rt following randomization (intent-to-treat population). The analysis includes participants with non-missing data for each dimension at baseline and week 12.|||units on a scale||Standard Error|Mean
1211335|NCT00797225|Secondary|Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved|"The PGIC is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
1211336|NCT00797225|Secondary|Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved|"The PGIC is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
1211337|NCT00797225|Secondary|Patient Global Impression of Change at Weeks 4, 8 and 12|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
1211338|NCT00797225|Secondary|Change From Baseline in Non-menstrual Pelvic Pain CPSSS Component|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration.~To assess non-menstrual pelvic pain, participants were asked to select the best description of pelvic pain over the past 28 days using the following response categories:~0 = Absent; No discomfort.~1 = Mild; Occasional pelvic discomfort that can be treated with NSAIDs.~2 = Moderate; Noticeable discomfort or pain for most of cycle requiring regular use of NSAID or weak opiate.~3 = Severe; Pain persisting during the cycle or pain requiring strong analgesics."|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). Data collection for this endpoint was added via a protocol amendment; therefore, the analysis only includes the subset of participants affected by the protocol amendment.|||units on a scale||Standard Error|Least Squares Mean
1211339|NCT00797225|Secondary|Change From Baseline in Dysmenorrhea Component of the CPSSS|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration.~To assess dysmenorrhea (pain during menstruation), participants were asked to select the best description of painful menstruation over the past 28 days using the following response categories:~0 = Absent; Amenorrhea (no bleeding) or no discomfort.~1 = Mild; Some loss of work efficiency; occasional use of analgesics.~2 = Moderate; In bed part of one day, occasional loss of work; regular use of analgesics.~3 = Severe; In bed ≥ 1 day, incapacitation; requirement for strong analgesics."|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). Data collection for this endpoint was added via a protocol amendment; therefore, the analysis only includes the subset of participants affected by the protocol amendment.|||units on a scale||Standard Error|Least Squares Mean
1211340|NCT00797225|Secondary|Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration.~To assess dyspareunia (painful intercourse) participants were asked to select the best description of pain during sexual intercourse over the past 28 days using the following response categories:~0 = Absent; No discomfort during sexual intercourse.~1 = Mild; I can tolerate the discomfort during sexual intercourse.~2 = Moderate; Intercourse is sometime interrupted due to pain.~3 = Severe; I prefer to avoid intercourse because of pain.~Not applicable. I am not sexually active for reasons other than my endometriosis symptoms."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at baseline and at each time point.|||units on a scale||Standard Error|Least Squares Mean
1211341|NCT00797225|Secondary|Change From Baseline in the Percentage of Days of Narcotic Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of “none”)."|Baseline, Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
1211342|NCT00797225|Secondary|Change From Baseline in the Percentage of Days of Prescription Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of “none”)."|Baseline, Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
1211352|NCT00797108|Other Pre-specified|Number of Participants With Healthcare Resource Utilization|Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization, date of discharge, location of discharge, type/length of treatment inside and outside of the hospital, healthcare professional visits outside of the hospital, emergency room visits, and other hospitalizations.|Baseline up to 15 to 28 days after EOT|This assessment was not performed due to the small sample size and hence data for this outcome measure is not reported.||||||
1211343|NCT00797225|Secondary|Change From Baseline in the Percentage of Days of Any Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of “none”)."|Baseline, Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
1211344|NCT00797225|Secondary|Change From Baseline in the Monthly Mean Sum of Dysmenorrhea and Non-menstrual Pelvic Pain Scores|"Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in an e-Diary. The dysmenorrhea scale included an option for participants who were not having their period.~The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1211345|NCT00797225|Secondary|Change From Baseline in the Monthly Mean Dysmenorrhea Score|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day of their period in an e-Diary according to the following response options:~Subject is not having her period~0 = No pain related to period~1 = Mild pain related to period; subject could not do some of the things she usually does~2 = Moderate pain related to period; subject could not do many of the things she usually does~3 = Severe pain related to period; subject could not do most of or all of the things she usually does.~The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1211346|NCT00797225|Secondary|Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:~0 = No pelvic pain~1 = Mild pelvic pain; subject could not do some of the things she usually does~2 = Moderate pelvic pain; subject could not do many of the things she usually does~3 = Severe pelvic pain; subject could not do most or all of the things she usually does.~The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1211347|NCT00797225|Secondary|Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1211348|NCT00797225|Primary|Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1211349|NCT00797212|Secondary|Percentage of Participant Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour|per protocol|||percent of participants|||Number
1211350|NCT00797212|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants as to their success at performing meter testing. The rating scale was:~Successful~Successful after being referred to user instructions~Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol|||percent of participants|||Number
1211351|NCT00797212|Primary|Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results|Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP|One hour|per protocol|||number of AST Blood Glucose Results|||Number
1211354|NCT00797108|Other Pre-specified|Number of Participants With Categorical Change From Baseline in Vital Signs|Participants who met the categorical criteria for increase in vital signs data were reported. Categorical criteria for increase from baseline vital signs data: supine and sitting systolic blood pressure (BP) of greater than or equal to (>=) 30 millimeter of mercury (mmHg); supine and sitting diastolic BP of >=20 mmHg.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants evaluable for this measure for specified category for each arm, respectively.|||participants|||Number
1211355|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, neurological, extremities, and others. Criteria for abnormal physical findings were based on investigator’s discretion.|Last observation (up to 15-28 days after EOT, approximately 38 days)|ITT population included all randomized participants who received at least 1 dose of double blind study drug.|||participants|||Number
1211356|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Criteria for laboratory abnormalities: hemoglobin (Hb), hematocrit, red blood cell (RBC) (less than [<] 0.8*lower limit of normal [LLN]); reticulocyte (absolute and percentage) (<0.5*LLN or greater than [>] 1.5*upper LN [ULN]); platelet (<0.5*LLN or >1.75*ULN); white blood cell (WBC) (<0.6*LLN or >1.5*ULN); lymphocyte, neutrophil (<0.8*LLN or >1.2*ULN); eosinophil, monocyte, basophil (>1.2*ULN); bilirubin (BR) (>1.5*ULN); aspartate and alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, lactate dehydrogenase (>3.0*ULN); total protein, albumin (<0.8*LLN or >1.2*ULN);blood urea nitrogen, creatinine (>1.3*ULN); sodium (<0.95*LLN or >1.05*ULN); potassium, chloride, calcium, magnesium, bicarbonate (<0.9*LLN or >1.1*ULN); glucose (<0.6*LLN or >1.5*ULN); urine (pH [<4.5 or >8], glucose, protein, blood, ketone [>=1]). Total number of participants with abnormal laboratory values were reported.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1211357|NCT00797108|Other Pre-specified|Number of Participants Who Died||Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug.|||participants|||Number
1211358|NCT00797108|Secondary|Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit|The CAP Symptom Questionnaire was a participant reported questionnaire administered by interview. It consisted of 12 items (coughing, chest pains, shortness of breath, sweating, chills, headache, nausea, muscle pain, lack of appetite, trouble concentrating, trouble sleeping, and fatigue). Depending on if the participant had or not had symptoms/problems, they were asked how much they had been bothered by the symptoms/problems over the previous 24 hours. CAP items were rated on the 6-point response scale (0 = participant did not have symptom/problem: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely; if the participant had the symptom/problem and were bothered). All 12 items score were summed and averaged to produce a CAP symptom score (range, 0 to 6). High values indicated poorer outcomes (higher symptom bothersomeness).|Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)|Clinically evaluable population. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1211359|NCT00797108|Secondary|Number of Participants With Microbiological Response at Test of Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication=the absence of the original pathogens from the post-treatment TOC culture of specimen from the original site of infection. Presumed eradication=the complete resolution of signs and symptoms associated with cessation of culturable specimen (for example, sputum). Persistence=the presence of the original pathogen in the post-treatment TOC culture specimen from the original site of infection. Presumed persistence=in a participant who was judged to be a clinical failure and a culture of specimen was not possible or was not done, it was presumed that there was persistence of the pathogen. Not applicable microbiologic response included participants that did not have post-treatment microbiologic cultures due to early discontinuation. Data reported for eradication is combination of eradication and presumed eradication data and data reported for persistence is combination of persistence and presumed persistence data.|7 to 14 days after EOT|Microbiologic clinically evaluable population included all microbiologic ITT participants (all ITT participants in whom a pathogen was isolated at baseline) who also met criteria for the clinically evaluable subset.|||participants|||Number
1211360|NCT00797108|Secondary|Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit|CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOT (Day 7 to 10) and follow-up (15 to 28 days after EOT), CR was evaluated as “cure”=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; “failure”=persistence or progression of baseline signs and symptoms of pneumonia, development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; with additional CR evaluated as “improvement”= of few not all signs and symptoms of pneumonia when compared to baseline and no additional antibacterial treatment required at EOT and “indeterminate”=extenuating circumstances precluded classification to 1 of the above at follow-up.|EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).|||percentage of participants|||Number
1211373|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils Plus Bands - All Treated Population|Neutrophils plus bands (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5.|Day 1 to Week 48||||participants|||Number
1211361|NCT00797108|Primary|Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit|Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment [EOT]) CR was evaluated as “cure”=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; “failure”=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell [WBC] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; “indeterminate”=extenuating circumstances precluded classification to 1 of the above.|7 to 14 days after end of treatment|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).|||percentage of participants|||Number
1211362|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Uric Acid - All Treated Population|Uric acid was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 * ULN - 10.0; GRADE (4): > 10.0 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211363|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Lipase - All Treated Population|Total Lipase (as measured with a turbidimetric assay) was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * ULN; GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 X ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211364|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Calcium (High) - All Treated Population|Total Calcium was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 8.0 - < LLN OR > ULN - 11.5; GRADE (2): 7.0 - < 8.0 > 11.5 - 12.5; GRADE (3): 6.0 - < 7.0 > 12.5 - 13.5; GRADE (4): < 6.0 > 13.5 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211365|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Amylase - All Treated Population|Amylase was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211366|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Serum Potassium (High) - All Treated Population|Serum potassium was measured as milliequivalents per liter (mEq/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN OR > ULN - 5.5;; GRADE (2): > 5.5 - 6.0; GRADE (3): 2.5 - < 3.0 > 6.0 - 7.0; GRADE (4): < 2.5 mEq/L.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211367|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Bilirubin - All Treated Population|Total Bilirubin was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 3.0 * ULN; GRADE (3): > 3.0 - 10.0 * ULN; GRADE (4): > 10.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211368|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alkaline Phosphatase - All Treated Population|Alkaline Phosphatase was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211369|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Albumin - All Treated Population|Albumin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): < LLN - 3.0; GRADE (2): < 3.0 - 2.0; GRADE (3): < 2.0 g/dL.|Day 1 to Week 48||||participants|||Number
1211370|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Aspartate Aminotransferase (AST) - All Treated Population|AST was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48||||participants|||Number
1211371|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alanine Aminotransferase (ALT) - All Treated Population|ALT was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211372|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Platelet Count - All Treated Population|Platelets were measured as *10^9 cells per liter (c/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 75.0 - < LLN; GRADE (2): 50.0 - < 75.0; GRADE (3): 25.0 - < 50.0; GRADE (4): < 25.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1212443|NCT00790556|Other Pre-specified|Hepatic Glucose Production (HGP) at Baseline||Baseline|Subjects who discontinued were not used in the analysis.|||mg/kg/min||Standard Deviation|Mean
1211374|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils - All Treated Population|Neutrophils (absolute) are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211375|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Lymphocytes - All Treated Population|Lymphocytes (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 0.8 - < 1.5; GRADE (2): 0.5 - < 0.8; GRADE (3): 0.2 - < 0.5; GRADE (4): < 0.2|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211376|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Leukocytes - All Treated Population|Leukocytes are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN; GRADE (2): 2.0 - < 3.0; GRADE (3): 1.0 - < 2.0; GRADE (4): < 1.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211377|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Hemoglobin - All Treated Population|Hemoglobin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 10.0 - less than (<) lower limit of normal (LLN); GRADE (2): 8.0 - < 10.0; GRADE (3): 6.5 - < 8.0; GRADE (4): < 6.5|Day 1 to Week 48||||participants|||Number
1211378|NCT00796991|Secondary|Mean Baseline Change in Body Temperature at Weeks 16 and 48 - All Treated Population|Temperature was obtained while the participant was sitting down and was measured in degrees Fahrenheit (F). During the induction phase this vital sign was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Temperature was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a temperature value available for analysis.|||degrees F||Standard Deviation|Mean
1211379|NCT00796991|Secondary|Mean Change From Baseline in Respiration Rate at Weeks 16 and 48 - All Treated Population|Respiration rate was obtained while the participant was sitting down and measured in breaths per minute (bpm). During the induction phase respiration rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Respiration rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Respiration rate value available for analysis.|||bpm||Standard Deviation|Mean
1211380|NCT00796991|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 16 and 48 - All Treated Population|Pulse rate was obtained while the participant was sitting down and measured in beats per minute (bpm). During the induction phase pulse rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Pulse rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Pulse rate value available for analysis.|||bpm||Standard Deviation|Mean
1211381|NCT00796991|Secondary|Mean Change From Baseline at Weeks 16 and 48 in Diastolic and Systolic Blood Pressure - All Treated Population|Blood pressure was obtained while the participant was sitting down and was measured in millimeters of mercury (mmHg). During the induction phase blood pressure was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Orthostatic blood pressure was to be measured when clinically indicated (for example, participant was experiencing lightheadedness, dizziness, syncope). Blood pressures were recorded at Weeks 1, 4, 7, 10,13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had blood pressure value available for analysis.|||mmHg||Standard Deviation|Mean
1211382|NCT00796991|Secondary|Mean Absolute Lymphocyte Count (ALC) at Each Nominal Ipilimumab Induction Dose and at End of the Induction Period - Pharmacodynamic Population|Absolute lymphocyte counts were obtained from routine hematology panels from 28 days prior to the first treatment with any study medication through the end of the Induction-Dosing Period and were reported as number*10^3 cells per micro liter (x10^3 c/µL).|Day to Week 12|"Pharmacodynamic Population: All treated participants with one unambiguous date of first dose; and at least 1 ALC evaluation during the induction-dosing period. For each of these participants, all ALC evaluations from 28 days prior to first dose of any study medication to the end of the induction dosing are included.~period."|||10^3 cells/µL||95% Confidence Interval|Mean
1211383|NCT00796991|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, Deaths, and Discontinuation Due to Adverse Events From Day 1 to Week 48 - All Treated Population|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Week 48 database lock was 27 July 2010.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211384|NCT00796991|Secondary|Number of Participants With Objective Response to Treatment and Disease Control Using mWHO Criteria - All Randomized Participants|Number of participants with an objective response to treatment excluded participants with a best overall response (BOR) of Stable Disease (SD). Disease control is non-progression of disease while on treatment. A participant was considered to have achieved disease control if he/she had a BOR of CR, PR, or SD in the absence of resected index lesions or new lesions while the participant was considered to have an objective response to treatment in he/she had a BOR of CR or PR in the absence of resected index lesions or new lesions.|Day 1 to Week 48|Randomized Population includes all participants randomized to a treatment arm|||participants|||Number
1222223|NCT00721188|Primary|Time to Maximum Serum Concentration (Tmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
1211385|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Immune Related (ir) Response Criteria (RC) - All Treated Participants|Assessments: Weeks 12, 16, 20, and 24. Participants with resected index or new lesions considered progressed in their disease. The immune-related (ir) response criteria (irRC) represents further modifications of mWHO criteria reflecting clinical experience with ipilimumab in which objective and durable responses (as per mWHO) were observed in participants following progression and without intervening alternative anti-cancer therapy. Immune-related (ir)Complete Response (irCR): Complete disappearance of all index lesions; ir Partial Response (irPR): Decrease, relative to baseline, of 50% or greater in sum of products of the two largest perpendicular diameters of all index and all new measurable lesions, in the absence of irCR; ir Stable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (PD); ir PD: At least 25% increase in Tumor Burden compared to sum of product diameters (SPD) at nadir. ir Unknown=participants overall response not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211386|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Modified World Health Organization (mWHO) Criteria - All Treated Participants|Assessments for antitumor activity by physical exam and routine anatomic imaging were at Week 12 and confirmatory imaging at Weeks 16, 20, and 24. Participants with resected index or new lesions were considered progressed in their disease. Complete Response (CR): Complete disappearance of all index lesions; Partial Response (PR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease (SD): Does not meet criteria for complete or partial response, in the absence of progressive disease. Participants with PR or CR that was not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions; Progressive Disease: At least 25% increase in the sum of products of all index lesions and/or the appearance of any new lesion(s). Unknown=the participants overall response was not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1211387|NCT00796991|Secondary|Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Vss reported in liters(L): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||L||Geometric Coefficient of Variation|Geometric Mean
1211388|NCT00796991|Primary|Area Under the Concentration Time Curve (AUC) From Time Zero to 21 Days [AUC(0-21d)] for Ipilimumab and AUC Time Zero Extrapolated to Infinity [AUC(INF)] for Paclitaxel, Dacarbazine and the Active Metabolite AIC - Pharmacokinetic Analysis Population|AUC=micrograms*hour(h) per mL (µg*h/mL): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1211389|NCT00796991|Secondary|Pharmacokinetic Parameter of Clearance (CLT) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|CLT reported in milliliters/hour (mL/h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
1211404|NCT00796757|Secondary|Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1211390|NCT00796991|Secondary|Pharmacokinetic Parameter of Terminal Elimination Half Life (T-HALF) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|T(HALF) reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||h||Standard Deviation|Mean
1211391|NCT00796991|Secondary|Pharmacokinetic Parameter of Time of Maximum Observed Concentration (Tmax) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Tmax reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||h||Full Range|Median
1211392|NCT00796991|Primary|Pharmacokinetic Parameter Maximum Observed Serum Concentration (Cmax) for Ipilimumab, Paclitaxel, Dacarbazine and the Active Metabolite for Dacarbazine, 5-aminoimidazole-4carboxamide (AIC)- Pharmacokinetic Analysis Population|Cmax=micrograms per milliliter (µg/mL): drug concentration versus time for ipilimumab (Day 43) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma by Enzyme-linked Immunosorbent Assay (ELISA); lower level of quantitation (LLOQ)=0.8 µg/mL; upper limit of quantitation (ULOQ)=25.6 µg/mL; Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; from Day 162 on every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined using liquid chromatography tandem mass spectrometry (LC/MS/MS) detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography atmospheric pressure ionization (API) tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate Pharmacokinetic (PK) profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1211393|NCT00796926|Secondary|Superior and Inferior Tear Meniscus Height|This is determined by anterior segment OCT visante system|6 weeks|||||||
1211394|NCT00796926|Secondary|Tear Osmolarity|This is measured by the TearLab (Ocusense) system|6 weeks|||||||
1211395|NCT00796926|Secondary|Meibography Grading||6 weeks|||||||
1211396|NCT00796926|Secondary|Schirmer I Reading||6 weeks|||||||
1211397|NCT00796926|Secondary|Tear Break Up Time (TBUT)||6 weeks|||||||
1211398|NCT00796926|Secondary|Corneal Fluorescein Staining Score|This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any|6 weeks|||||||
1211399|NCT00796926|Primary|Visual Analog Score (VAS)|Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum|6 weeks|intention to treat|||scores on a scale||Standard Deviation|Mean
1211400|NCT00796861|Primary|Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.|A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.|An average of every 6 weeks|No analyses were performed as none of the subjects made it through a full cycle.||||||
1211401|NCT00796822|Secondary|Change in Soluble TNF-Receptor I Levels|Measure of systemic inflammation|Measured at baseline and Week 8|Those who had both baseline and Week 8 data available|||pg/mL||Standard Deviation|Mean
1211402|NCT00796822|Primary|Change in Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.|Measured at baseline and Week 8|Number of remaining participants at week 8 with evaluable vascular ultrasonography. In the Pentoxifylline group, 10 participants were evaluated at week 8 but only 9 had evaluable ultrasonography.|||absolute percentage||Standard Deviation|Mean
1211403|NCT00796757|Secondary|EQ-5D - Visual Analog Scale (VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1211405|NCT00796757|Secondary|OS - Time to Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||months||95% Confidence Interval|Median
1211406|NCT00796757|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants|||Number
1211407|NCT00796757|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months|OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants||95% Confidence Interval|Number
1211408|NCT00796757|Primary|PFS - Time to Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population|||months||95% Confidence Interval|Median
1211409|NCT00796757|Primary|PFS - Percentage of Participants With an Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants|||Number
1211410|NCT00796757|Secondary|Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)|Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population; only participants with measurable disease were included in the analysis.|||percentage of participants|||Number
1211411|NCT00796757|Primary|Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|12 and 24 months|ITT population|||percentage of participants||95% Confidence Interval|Number
1211412|NCT00796744|Secondary|The Time to Re-epithelialization of the Ulcer Site.|Average time to complete re-epithelialization of baseline ulcer area.|24 weeks||||Weeks||Standard Error|Mean
1211413|NCT00796744|Secondary|The Rate of Re-epithelialization of the Ulcer Site.|The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.|12 weeks||||percent ulcer area re-epithelialized/wk||Standard Deviation|Mean
1211414|NCT00796744|Secondary|The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.||Duration of subject's participation (24 weeks)|Safety Population|||patients|||Number
1211415|NCT00796744|Primary|The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.||Healing to occur within 12 weeks of first treatment|Intent-to-Treat Population|||number of ulcers healed|||Number
1211416|NCT00796718|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|Up to 15 weeks|All enrolled participants.|||percentage of participants|||Number
1211417|NCT00796718|Secondary|Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 15 weeks (assessed 1 month after surgery)|Participants with available data.|||percentage of participants|||Number
1211725|NCT00795145|Secondary|Cohort 2: AUC Inf and AUC Last|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.~AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||ug *hr/mL||Standard Deviation|Mean
1211418|NCT00796718|Secondary|Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)|Participants with available data.|||percentage of participants|||Number
1211419|NCT00796718|Primary|Percentage of Participants With Pathological Complete Response|Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.|Up to 11 weeks (assessed at the time of post-treatment surgery)|Participants with available data.|||percentage of participants|||Number
1211420|NCT00796705|Secondary|Participants With an ACR 70 Response at Week 12|"The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
1211421|NCT00796705|Secondary|Participants With an ACR 50 Response at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
1211422|NCT00796705|Secondary|Participants With an ACR 20 Response at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
1211423|NCT00796705|Secondary|Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)|The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28[CRP] value of ≥ 1.2.|Baseline, Week 12|Intent-to-treat|||participants|||Number
1211424|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat|||participants|||Number
1211425|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat|||participants|||Number
1211426|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat|||Scores on a scale||Standard Deviation|Mean
1211427|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat|||Scores on a scale||Standard Deviation|Mean
1211428|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Physical Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211429|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211430|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211431|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211432|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211433|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Vitality score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211434|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211435|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211436|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211437|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 and ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1211438|NCT00796666|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48|WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X.|Baseline, Weeks 12, 24 or ET|ITT|||participant|||Number
1211439|NCT00796666|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change from baseline = score at Week x - score at baseline.|Baseline to Weeks 12 and 24|ITT; N=number of participants analyzed; Missing values at Weeks 12 and 24 imputed with the last non-missing 6MWD based on the last observation carried forward (LOCF) method|||meters (m)||Standard Deviation|Mean
1211530|NCT00796510|Secondary|Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)|The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).|Baseline, Week 12 and ET (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||||||
1211440|NCT00796666|Primary|Time to Clinical Worsening (TTCW)|Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study’s first dose date in and date when first clinical worsening event occurs.|Baseline, Weeks 12, 24 or Early Termination (ET)|Intent-to-Treat population (ITT): all participants who were randomized|||Days||Full Range|Median
1211441|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
1211442|NCT00796653|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first study drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1211443|NCT00796653|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.|||percentage of participants|||Number
1211444|NCT00796653|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1211445|NCT00796653|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1211446|NCT00796653|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1211447|NCT00796653|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
1211448|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
1211449|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
1211450|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211451|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211531|NCT00796510|Secondary|Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24|The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.|Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||||||
1211452|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211453|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211454|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211455|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211456|NCT00796653|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211457|NCT00796653|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211458|NCT00796653|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211459|NCT00796653|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211460|NCT00796653|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS|||Number of puffs||Standard Error|Mean
1211461|NCT00796653|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS|||L/min||Standard Error|Mean
1211462|NCT00796653|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211532|NCT00796510|Primary|Overall Survival|Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.|Baseline and every 12 weeks up to Week 18|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||||||
1211726|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population|||msec|||Number
1211463|NCT00796653|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211464|NCT00796653|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211465|NCT00796653|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211466|NCT00796653|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211467|NCT00796653|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
1211468|NCT00796653|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
1211469|NCT00796653|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
1211470|NCT00796653|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
1211727|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population|||msec|||Number
1211471|NCT00796653|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
1211472|NCT00796653|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
1211473|NCT00796653|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
1211474|NCT00796653|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
1211475|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211476|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211477|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211485|NCT00796653|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
1211478|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211479|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211480|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211481|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211482|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211483|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211484|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211848|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 9|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211486|NCT00796653|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
1211487|NCT00796653|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
1211488|NCT00796653|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
1211489|NCT00796653|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
1211490|NCT00796653|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
1211491|NCT00796653|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
1211492|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211493|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1222224|NCT00721188|Primary|Maximum Observed Serum Concentration (Cmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug/dL||Standard Deviation|Mean
1211494|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211495|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211496|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211497|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211498|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211499|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211500|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211501|NCT00796653|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
1211514|NCT00796614|Secondary|Change From Baseline in LPP at Week 14 (End of Treatment)|Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.|Baseline and Week 14|Full analysis set-LPP (FAS-LPP), OT|||cm H2O||Standard Error|Least Squares Mean
1211533|NCT00796419|Secondary|Ventilator-free Days|The ‘ventilator free survival days’ in a 30-day period is a previously validated method of comparing groups with respect to mechanical ventilator requirements while adjusting for mortality. This variable represents the number of days in the 30-day period following baseline that the patient is alive and not requiring mechanical ventilation.|Day 30||||days||Inter-Quartile Range|Median
1212666|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Number of Adverse Effects Including a) All Events; b) All Events Requiring Unblinding of the Treatment; c) All Events Requiring Early Termination of the Intervention||10-14 weeks|||||||
1211502|NCT00796653|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211503|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|73 hours to 6 weeks post-operative|Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
1211504|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|49 to 72 hours post-operative|Data only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
1211505|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|0 to 24 hours post-operative|Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
1211506|NCT00796627|Primary|The Quantification of Circulating Angiogenic Cells in the Blood of Individuals Who Are Healthy Volunteers Compared to Those in Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|baseline||||cells per standard well||Full Range|Mean
1211507|NCT00796614|Secondary|Post Void Residual Volume at Week 14|Median change from baseline to Week 14 in post void residual (mL) by study treatment.|Baseline and Week 14.|Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.|||mL||Standard Deviation|Median
1211508|NCT00796614|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.|"Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis.~Relevant findings or worsening of baseline conditions were reported as adverse events."|From first drug administration until 28 days after last study drug administration, upto 160 days|"Treated Set (TS).~All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study."|||Participants|||Number
1211509|NCT00796614|Secondary|Change From Baseline in Number of Times Patient Was Wet at Catheterisation|Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH)|||Times patient wet at catheterization||Standard Error|Least Squares Mean
1211510|NCT00796614|Secondary|Change From Baseline in Urine Volume at Week 14|Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.|||mL||Standard Error|Least Squares Mean
1211511|NCT00796614|Secondary|Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline|"Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).~Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14."|Baseline and Week 14|Full analysis set-renal (FAS-RENAL)|||Participants|||Number
1211512|NCT00796614|Secondary|Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline|"Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.~The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization"|Baseline and Week 14|Full analysis set-renal (FAS-RENAL): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.|||Participants|||Number
1211513|NCT00796614|Secondary|Percentage Change From Baseline in LPP at Week 14 (End of Treatment)|Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.|Baseline and Week 14.|Full analysis set-LPP (FAS-LPP), OT|||Percentage change||Standard Error|Least Squares Mean
1211587|NCT00795951|Primary|Diagnostic Performance: Carba Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211515|NCT00796614|Primary|Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.|The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.|Week 14|Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.|||Percentage of participants|||Number
1211516|NCT00796549|Secondary|Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status|"Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below :~0 : Fully active, able to carry on all pre-disease performance without restriction.~: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.~: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.~: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.~: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.~: Dead.~Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included."|End Of Treatment, up until 190 weeks|Treated set (TS).|||percentage of participants|||Number
1211517|NCT00796549|Secondary|Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction|"Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.~There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF)."|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).|||percentage of participants|||Number
1211518|NCT00796549|Secondary|Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder|The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs.|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).|||Percentage of participants|||Number
1211519|NCT00796549|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.|Day 15|"Pharmacokinetic set (PK set) contains all patients who received study medication and have evaluable pharmacokinetic parameter data.~Data from patients who received the starting dose of 50 mg afatinib and were still on treatment and not dose-reduced on Day 15 are presented."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1211520|NCT00796549|Secondary|Overall Survival (OS) Time|Overall survival time is defined as time from the date of start of treatment to the date of death.|Baseline until last vital status assessment 17JUN13|Treated set (TS).|||Weeks||95% Confidence Interval|Median
1211521|NCT00796549|Secondary|Progression Free Survival (PFS) Time|Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||Weeks||95% Confidence Interval|Median
1211522|NCT00796549|Secondary|Duration of Confirmed Disease Control|Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||Weeks||Standard Deviation|Mean
1211523|NCT00796549|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||percentage of participants||95% Confidence Interval|Number
1211524|NCT00796549|Secondary|Duration of Confirmed Objective Response (OR)|Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).|||Weeks||Standard Deviation|Mean
1211525|NCT00796549|Secondary|Number of Participants With Objective Response (OR) Categorized by Time|Cumulative number of participants with objective response by time points with responders.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).|||percentage of participants|||Number
1211526|NCT00796549|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||percentage of participants||95% Confidence Interval|Number
1211527|NCT00796523|Primary|Hours Per Day of Sleep|mean sleep time is the mean of 3 daily sleep times reported in a time period.|week 8|Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis|||hours per day||Standard Deviation|Mean
1211528|NCT00796523|Primary|Hours Per Day of Fuss/Cry|total hours per day of fuss, cry, and unsoothable crying.|week 8|If fewer than 3 diaries were completed for a given time period (that is, one or two of the days was missing or had more than 180 minutes unrecorded), then the average of only the completed diaries was used. Results are based on ITT; 16 subjects did not complete any diaries and are not included in the analysis|||hours per day||Standard Deviation|Mean
1212667|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Incidence of Significant Cardiac Arrhythmias in the Acute Phase||48 hours|||||||
1211534|NCT00796419|Secondary|Change in Oxygenation (PaO2/FiO2 Ratio)|Change in arterial oxygenation measured by arterial blood gas analysis. The partial pressure of O2 in arterial blood to fraction of inspired oxygen ratio (PaO2/FiO2) is a ratio of partial pressure arterial oxygen to fractional inspired inspired oxygen. This ratio is used as an indicator of hypoxemia (low blood oxygen). A PaO2/FiO2 ratio of 200-300 indicates mild ARDS, 100-200 indicates moderate ARDS, and less than 100 indicates severe ARDS.|Baseline, Day 1||||mmHg||Standard Deviation|Mean
1211535|NCT00796419|Primary|Change in Extravascular Lung Water (EVLW)|Quantity of extravascular lung water (EVLW) measured by transpulmonary thermodilution. Higher measurements of EVLW per kilogram of body weight indicate increased lung injury. Normal values for EVLW are thought to be less than 10 mL/kg.|Baseline to Day 5 (120 hours)||||mL/kg||Standard Deviation|Mean
1211536|NCT00796367|Primary|Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.||Baseline to End of Treatment|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent participants|||Number
1211537|NCT00796367|Primary|Percent Weight Change at End of Treatment, Week 108.||From baseline to end of treatment|Intent-to-Treat Last observation carried forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
1211538|NCT00796328|Primary|Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension|The effective dose at which 90% of subjects will have a “positive” response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 – 60 mcg/min.|Spinal administration until delivery||||dose of phenylephrine|||Number
1211539|NCT00796315|Primary|Cmax of Doxylamine|Maximum concentration of Doxylamine from 0 to 72 hours post-dose|72 Hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1211540|NCT00796315|Primary|AUC of Doxylamine|Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.|72 Hours||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1211541|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Severity of Illness|Using this clinician rating scale the severity of the illness is scored from 1= normal to 7= extremely ill. This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Severity of Illness scores are reported below.|Measured at endpoint visit|ADHD and severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Severity of Illness rating|||participants|||Number
1211542|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Improvement|Using this clinician rating scale the patient's improvement is scored on a 7-point scale which ranges from “very much improved” (1), through “no change” (4), to “very much worse” (7). This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Improvement scores are reported below.|Measured at endpoint visit|ADHD & severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Improvement rating|||participants|||Number
1211543|NCT00796302|Other Pre-specified|Antisocial Behavior Scale - Reactive Aggression Subscale|The Antisocial Behavior Scale (ABS) is a 28-item scale that contains 10 Proactive Aggression items and six Reactive Aggression items. Each item is rated on a 3-point scale, ranging from 1 (Never) to 3 (Very often). Thus, scores on the Reactive Aggression subscale can range from 6 through 18; with higher scores indicating more reactive aggression.|Measured at baseline and Week 9|ADHD & severe physical aggression|||units on a scale||Standard Deviation|Mean
1211544|NCT00796302|Primary|NCBRF-TIQ D-Total Score|"Parent ratings of aggression and hostility on the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ) D-Total Score. The NCBRF provides 1 prosocial subscale (Positive/Social) and 6 problem behavior subscales (Conduct Problem, Oppositional Behavior, Hyperactive, Inattentive, Overly Sensitive, and Withdrawn/Dysphoric). The NCBRF has excellent internal consistency, distinguishes between controls and subjects with DBDs. Conduct Problem and Oppositional Behavior subscales map closely to DSM-IV-TR symptoms of CD and ODD; they were scored together to form a variable called the D-Total.~For the NCBRF D-Total, higher scores reflect worse behavior. Each subscale is scored by taking the rating (0 [did not occur or was not a problem] to 3 [occurred a lot or was a very severe problem]) for all component items. The D-Total score was computed by adding the 6 scores from the Oppositional subscale and the 10 items from the Conduct Problem subscale. Thus D-Total scores could range from 0-69."|Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9|ADHD & severe physical aggression|||units on a scale||Standard Deviation|Mean
1211545|NCT00796224|Secondary|Adverse Events (AEs) and Serious AEs (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.|Baseline up to 28 days|All subjects who received at least 1 dose of study medication were included in the safety analyses.|||participants|||Number
1211546|NCT00796224|Secondary|Number of Participants With a Clinical Response|"Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following:~Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary;~New clinical signs and symptoms of acute illness have developed and additional therapy is necessary"|Days 7,8,9 or 10|Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events.|||participants|||Number
1211547|NCT00796224|Secondary|Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)||1,2,3,4,8,24,48,72 hours postdose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/ml|||Number
1211548|NCT00796224|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||hr||Full Range|Median
1211549|NCT00796224|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azithromycin||Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/ml||Standard Deviation|Mean
1211550|NCT00796224|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)|AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng*hr/ml||Standard Deviation|Mean
1211551|NCT00796224|Primary|Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)|AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.|Predose/0 to 72 Hours|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng*hr/ml||Standard Deviation|Mean
1211552|NCT00796120|Secondary|Duration of Response (DOR)|The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.|Up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
1211553|NCT00796120|Secondary|Overall Survival|Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline up to End of Study (an average of 4 years)|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||months||95% Confidence Interval|Median
1211554|NCT00796120|Secondary|Percentage of Participants With Objective Response|Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||percentage of participants||95% Confidence Interval|Number
1211555|NCT00796120|Secondary|6-month Progression - Free Survival|Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.|6 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||percentage of participants||95% Confidence Interval|Number
1211556|NCT00796120|Primary|Progression - Free Survival (PFS)|The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS)|||months||95% Confidence Interval|Median
1211557|NCT00796003|Secondary|Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial)|IWG 2000 - Major: disappearance of cytogenetic abnormality; Minor: 50% or more reduction in abnormal metaphases. IWG 2006 - Complete: disappearance of the chromosomal abnormality without appearance of new ones; Partial: At least 50% reduction of the chromosomal abnormality.|Up to 1.5 years after the last participant enrolled|20 participants who had chromosomal abnormality were evaluated in Phase II for cytogenetic response. The IWG criteria requires 20 analyzable metaphases using conventional cytogenetic techniques.|||Participants|||Number
1211558|NCT00796003|Secondary|Phase II: Overall Improvement Rate: Number of Participants Who Achieved Complete Response (CR)+Partial Response (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 1.5 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this set|||Participants|||Number
1211559|NCT00796003|Secondary|Phase II: Median Duration of Overall Improvement|Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement).|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.|||Days||Full Range|Median
1211560|NCT00796003|Secondary|Phase II: Median Duration of Remission|Median time duration for which participants achieved remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.|||Days||Full Range|Median
1211561|NCT00796003|Secondary|Phase II: Median Time to Improvement|Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement)|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.|||Days||95% Confidence Interval|Median
1211562|NCT00796003|Secondary|Phase II: Median Time to Remission|Median time required for the participants to achieve remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.|||Days||95% Confidence Interval|Median
1211588|NCT00795951|Primary|Diagnostic Performance: Epoxy Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211563|NCT00796003|Secondary|Phase I: Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia; PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes; HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 28 Days of treatment Cycle 1|Full Analysis Set (FAS): 9 participants were included in this set for Phase I|||Participants|||Number
1211564|NCT00796003|Secondary|Phase I: Area Under the Plasma Concentration-time Curve (AUC)|Area under the curve from time zero to extrapolated infinite time (AUC Infinity) and area under the curve from time zero to last quantifiable concentration (AUC Last).|Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis|||ng*h/mL||Standard Deviation|Mean
1211565|NCT00796003|Secondary|Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax)||Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis|||ng/mL||Standard Deviation|Mean
1211566|NCT00796003|Primary|Phase I and II: Number of Participants Who Experienced Adverse Events||Up to 1.5 years after the last participant enrolled|Safety Population: 9 participants in Phase I and 34 participants in Phase II were evaluated for safety|||Participants|||Number
1211567|NCT00796003|Primary|Phase II: Overall Remission Rate (ORR): Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes.|Up to 1 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this analysis set for Phase II|||Participants|||Number
1211568|NCT00795951|Secondary|Itching/Burning|Number of subjects who presented with itching/burning at patch removal|Day 2: 48 hours after patch application||||participants|||Number
1211569|NCT00795951|Secondary|Adhesion|Number of subjects who presented with poor adhesion at patch removal|Day 2: 48 hours after application||||participants|||Number
1211570|NCT00795951|Secondary|Irritation|Number of subjects who presented with irritation at patch removal|Visit 2: 48 hours after patch application||||participants|||Number
1211571|NCT00795951|Secondary|Persistent Reactions|Number of subjects who presented with persistent reactions|appear 2-4 days after patch application and last through 7-14 days after application||||participants|||Number
1211572|NCT00795951|Secondary|Late Reactions|Number of subjects who presented with late reactions|7-10 days after patch application||||participants|||Number
1211573|NCT00795951|Primary|Diagnostic Performance: Quinoline Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211574|NCT00795951|Primary|Diagnostic Performance: Tixocortol-21-pivalate|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211575|NCT00795951|Primary|Diagnostic Performance: Budesonide|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211576|NCT00795951|Primary|Diagnostic Performance: Imidazolidinyl Urea|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211577|NCT00795951|Primary|Diagnostic Performance: Diazolidinyl Urea|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211578|NCT00795951|Primary|Diagnostic Performance: Thiuram Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211579|NCT00795951|Primary|Diagnostic Performance: Thimerosal|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211580|NCT00795951|Primary|Diagnostic Performance: Mercapto Mix|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211581|NCT00795951|Primary|Diagnostic Performance: Formaldehyde|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211582|NCT00795951|Primary|Diagnostic Performance: p-Phenylenediamine|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211583|NCT00795951|Primary|Diagnostic Performance: Mercaptobenzothiazole|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211584|NCT00795951|Primary|Diagnostic Performance: Quaternium-15|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211585|NCT00795951|Primary|Diagnostic Performance: Cl+Me-Isothiazolinone|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211586|NCT00795951|Primary|Diagnostic Performance: Black Rubber Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1211600|NCT00795951|Primary|Diagnostic Performance: Neomycin Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|The prevalence of allergic contact dermatitis varies greatly (≤1%-10%) in consecutive subjects. Therefore, estimates of sample size and study power are based on overall AE rates, which are generally similar across populations and test allergens and for which there is relevant historical data.|||participants|||Number
1211601|NCT00795951|Primary|Diagnostic Performance: Nickel Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All completed subjects were included in the efficacy analysis.|||participants|||Number
1211602|NCT00795886|Primary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation. The Kaplan-Meier product limit method was used to compute the probability of overall survival to 2 years. Greenwood's formula was used to compute the standard error.|24 months after transplant|All patients enrolled in study.|||probability||Standard Error|Mean
1211603|NCT00795886|Secondary|Percentage of Patients Developing Acute Graft vs. Host Disease (GVHD)|Cumulative incidence of Grade 2-4 acute GVHD at 180 days.|180 days||||percentage of participants||95% Confidence Interval|Number
1211604|NCT00795886|Primary|Number of Participants With Transplant-related Mortality|Death not associated with relapse. We determined that if transplant related mortality(TRM) 25% at day 100 or if Grade III-IV (severe, life threatening, or disabling) acute GVHD was >30% a stopping rule would be triggered.|24 months after transplant|All participants enrolled in the trial.|||participants|||Number
1211605|NCT00795821|Secondary|Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684|Blood samples collected from participants that received LY2216684 were measured to determine the plasma LY2216684 concentrations.|Baseline through Week 62|N=number of participants analyzed (N=365); n=number of plasma LY2216684 concentration observations. The sum of the individual ‘n’ values for each dose group does not equal 365 since the same participant could have received various doses during his/her participation in the study.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1211606|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Supine Pulse at Week 62|Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1211607|NCT00795821|Secondary|Mean Change From Baseline in Supine Pulse at Week 10|Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1211608|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Supine Systolic and Diastolic Blood Pressure at Week 62|Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
1211609|NCT00795821|Secondary|Mean Change From Baseline in Supine Systolic and Diastolic Blood Pressure at Week 10|Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
1211610|NCT00795821|Secondary|Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62|"C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a yes answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a yes answer to actual attempt or completed suicide."|Baseline (Week 10) through Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
1211611|NCT00795821|Secondary|Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10|"C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a yes answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a yes answer to actual attempt or completed suicide."|Baseline through Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline C-SSRS value.|||percentage of participants|||Number
1211612|NCT00795821|Secondary|Percentage of Participants Reporting Resource Utilization at Week 62|The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.|Baseline (Week 10) through Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
1211613|NCT00795821|Secondary|Percentage of Participants Reporting Resource Utilization at Week 10|The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.|Baseline through Week 10|The analysis population included all randomized participants.|||percentage of participants|||Number
1211614|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 62|The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211615|NCT00795821|Secondary|Mean Change From Baseline in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 10|The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211616|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Brief Fatigue Inventory (BFI) Global Total Score at Week 62|The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its “worst,” “usual,” and “now” during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant’s life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211617|NCT00795821|Secondary|Mean Change From Baseline in the Brief Fatigue Inventory (BFI) Global Total Score at Week 10|The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its “worst,” “usual,” and “now” during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant’s life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211618|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211619|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211620|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1-5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211621|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1 to 5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211663|NCT00795600|Secondary|Absolute Change in Basophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||10^9 cells/L||Standard Deviation|Mean
1211622|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211623|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211624|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 62|EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, mood. Single score between 1 and 3 was generated for each domain. For each participant, outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211625|NCT00795821|Secondary|Mean Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 10|EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211626|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 62|The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211627|NCT00795821|Secondary|Mean Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 10|The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211628|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 62|The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211629|NCT00795821|Secondary|Mean Change From Baseline in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 10|The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all participants with a baseline and at least 1 post-baseline value in the Per Protocol population, defined as the subset of randomized participants who had baseline and post-baseline data collected using the correct version of the QIDS-SR16 worksheet.|||units on a scale||Standard Error|Least Squares Mean
1211630|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 62|CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for investigator, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211706|NCT00795535|Primary|Serious Injury|A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
1211631|NCT00795821|Secondary|Mean Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10|CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211632|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 62|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211633|NCT00795821|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 10|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211634|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 62|The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211635|NCT00795821|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10|The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1211636|NCT00795769|Primary|Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)|Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.|Baseline up to 120 minutes||||Participants|||Count of Participants
1211637|NCT00795717|Secondary|Brachial Artery Reactivity|"To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.~Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of % of brachial artery."|12 weeks||||% of brachial artery diameter||Standard Deviation|Mean
1211638|NCT00795717|Secondary|Serum HDL Level||12 weeks||||mg/dl||Standard Deviation|Mean
1211639|NCT00795717|Primary|Change in Baseline Mean Serum Triglyceride Level at Study End|Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo|Baseline and 12 weeks|Randomized, cross over design|||mg/dl||Standard Deviation|Mean
1211640|NCT00795704|Secondary|Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages|2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.|Baseline and 3 months|Intention-to-treat with data submitted baseline and final.|||mg/dL||Standard Deviation|Mean
1211641|NCT00795704|Secondary|Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels|Sodium (>150 mmol/L), Potassium (>5 mmol/L), Bicarbonate (>34 mmol/L), Chloride (>110 mmol/L), Serum Creatinine (>1.2 mg/dL), Blood Urea Nitrogen (24 mg/dL), Calcium (>11 mg/L), Alanine Aminotransferase (>3 times baseline), Aspartate Aminotransferase (>3 times baseline) were collected at baseline, 1 month, and 3 months. Self-Reported adverse drug reactions are also reported.|Baseline, 1 month, and 3 months||||participants|||Number
1211642|NCT00795704|Primary|Hemoglobin A1C||3 month minus baseline|intention-to-treat|||percent||Standard Deviation|Mean
1211643|NCT00795639|Secondary|Time to Clinical Worsening (TTCW)|TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events included: hospitalization for worsening PAH, on-study death, heart-lung or lung transplant, atrial septostomy or withdrawal due to the addition of any chronic medications for the treatment of worsening PAH.|Baseline, Weeks 4, 8 and 12 or ET|ITT; N=number of participants with analyzable data|||days||Full Range|Median
1211644|NCT00795639|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12|WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Improvement = reduction in functional class, deterioration = increase in functional class, no change = no change in functional class.|Baseline, Weeks 4, 8 and 12 or Early Termination (ET)|ITT; N=number of participants with analyzable data; n=number of participants with analyzable data at the specific time point|||participants|||Number
1211645|NCT00795639|Primary|Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change is Week 12 results minus baseline results.|Baseline/Day 1 and Week 12|Intent to treat population (ITT): all participants who were randomized; missing value at Week 12 imputed with last non-missing value, including the non-missing value obtained at early termination based on last observation carried forward (LOCF)|||Meters (m)||Full Range|Median
1211646|NCT00795600|Secondary|Number of Non-serious Adverse Events|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.|||events|||Number
1211647|NCT00795600|Secondary|Number of Hypoglycaemic Episodes|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.|||episodes|||Number
1211648|NCT00795600|Secondary|Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects from the Insulin Detemir group and one subject from the Insulin NPH group did not show a PAI-1 available value at week 0. Three subjects from each treatment group did not present a PAI-1 available value at week 26.|||ng/L||Standard Error|Least Squares Mean
1211649|NCT00795600|Secondary|Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)|Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject from each treatment group did not present a hsCRP available value at week 0. Two subjects from the Insulin Detemir group and three subjects from the Insulin NPH group did not show a hsCRP available value at week 26.|||mg/L||Standard Error|Least Squares Mean
1211650|NCT00795600|Secondary|Absolute Change in Hip Circumference|Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in hip circumference at week 26.|||cm||Standard Error|Least Squares Mean
1211651|NCT00795600|Secondary|Absolute Change in Waist Circumference|Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in waist circumference at week 26.|||cm||Standard Error|Least Squares Mean
1211652|NCT00795600|Secondary|Absolute Change in Body Weight|Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in body weight at week 26.|||kg||Standard Error|Least Squares Mean
1211653|NCT00795600|Secondary|Absolute Change in Potassium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Potassium at week 26.|||mmol/L||Standard Deviation|Mean
1211654|NCT00795600|Secondary|Absolute Change in Sodium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Sodium at week 26.|||mmol/L||Standard Deviation|Mean
1211655|NCT00795600|Secondary|Absolute Change in Alkaline Phosphatase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the Alkaline Phosphatase at week 26.|||IU/L||Standard Deviation|Mean
1211656|NCT00795600|Secondary|Absolute Change in Aspartate Aminotransferase (ASAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ASAT at week 26.|||IU/L||Standard Deviation|Mean
1211657|NCT00795600|Secondary|Absolute Change in Alanine Aminotransferase (ALAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ALAT at week 26.|||IU/L||Standard Deviation|Mean
1211658|NCT00795600|Secondary|Absolute Change in Bilirubin Total||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Bilirubin Total at week 26.|||mg/dL||Standard Deviation|Mean
1211659|NCT00795600|Secondary|Absolute Change in Albumin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the albumin at week 26.|||mg/dL||Standard Deviation|Mean
1211660|NCT00795600|Secondary|Absolute Change in Urea||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Urea at week 26.|||mg/dL||Standard Deviation|Mean
1211664|NCT00795600|Secondary|Absolute Change in Eosinophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||10^9 cells/L||Standard Deviation|Mean
1211665|NCT00795600|Secondary|Absolute Change in Neutrophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||percentage||Standard Deviation|Mean
1211666|NCT00795600|Secondary|Absolute Change in Monocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Monocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
1211667|NCT00795600|Secondary|Absolute Change in Lymphocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Lymphocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
1211668|NCT00795600|Secondary|Absolute Change in Leucocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Leucocytes at week 26.|||10^9 cells/L||Standard Deviation|Mean
1211669|NCT00795600|Secondary|Absolute Change in Erythrocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Erythrocytes at week 26.|||percentage||Standard Deviation|Mean
1211670|NCT00795600|Secondary|Absolute Change in Thrombocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subjects in the Insulin Detemir group presented values at week 26 in thrombocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
1211671|NCT00795600|Secondary|Absolute Change in Blood Volume (Haematocrit)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the Haematocrit at week 26.|||percentage||Standard Deviation|Mean
1211672|NCT00795600|Secondary|Absolute Change in Haemoglobin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the haemoglobin at week 26.|||g/dL||Standard Deviation|Mean
1211673|NCT00795600|Secondary|Absolute Change in Free Fatty Acids||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the free fatty acids at week 26.|||mg/dL||Standard Deviation|Mean
1211674|NCT00795600|Secondary|Absolute Change in Triglycerides||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and six patients in the Insulin NPH group did not present a value in the triglycerides at week 26.|||mg/dL||Standard Deviation|Mean
1211675|NCT00795600|Secondary|Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and seven patients in the Insulin NPH group did not present a value in the VLDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
1211676|NCT00795600|Secondary|Absolute Change in Low Density Lipoprotein (LDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the LDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
1211677|NCT00795600|Secondary|Absolute Change in High Density Lipoprotein (HDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the HDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
1211678|NCT00795600|Secondary|Absolute Change in Total Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the total cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
1211679|NCT00795600|Secondary|Absolute Change in Adiponectin|Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Six subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the adiponectin at week 26.|||mcg/dL||Standard Error|Least Squares Mean
1211680|NCT00795600|Secondary|Absolute Change in Fasting Plasma Glucose (FPG)|Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and six subjects in the Insulin NPH group did not present a value in the fasting plasma glucose at week 26.|||mg/dL||Standard Error|Least Squares Mean
1211723|NCT00795145|Secondary|Cohort 2: Tmax and t1/2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Tmax is the time to reach Cmax.|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||hr||Full Range|Median
1211681|NCT00795600|Secondary|Absolute Change in HbA1c (Glycosylated Haemoglobin)|Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the hbA1c at week 26.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1211682|NCT00795600|Secondary|Percentage Change in Liver/Spleen Attenuation Ratio|Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.|||percent change||Standard Error|Least Squares Mean
1211683|NCT00795600|Secondary|Absolute Change in Liver/Spleen Attenuation Ratio|Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.|||ratio||Standard Error|Least Squares Mean
1211684|NCT00795600|Secondary|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.|||percent change||Standard Error|Least Squares Mean
1211685|NCT00795600|Secondary|Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.|||ratio||Standard Error|Least Squares Mean
1211686|NCT00795600|Secondary|Percentage Change in Subcutaneous Adipose Tissue Area|Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.|||percent change||Standard Error|Least Squares Mean
1211687|NCT00795600|Secondary|Absolute Change in Subcutaneous Adipose Tissue Area|Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.|||cm^2||Standard Error|Least Squares Mean
1211688|NCT00795600|Secondary|Percentage Change in Visceral Adipose Tissue Area|Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.|||percent change||Standard Error|Least Squares Mean
1211689|NCT00795600|Secondary|Absolute Change in Visceral Adipose Tissue Area|Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.|||cm^2||Standard Error|Least Squares Mean
1211690|NCT00795600|Secondary|Percentual Change in Calculated Trunk Fat Percentage|Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.|||percent change||Standard Error|Least Squares Mean
1211691|NCT00795600|Secondary|Absolute Change in Calculated Trunk Fat Percentage|Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.|||percent of trunk fat (%)||Standard Error|Least Squares Mean
1211692|NCT00795600|Secondary|Percentual Change in Calculated Whole Body Fat Percentage|Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.|||percent change||Standard Error|Least Squares Mean
1211693|NCT00795600|Secondary|Absolute Change in Calculated Whole Body Fat Percentage|Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.|||percent of whole body fat (%)||Standard Error|Least Squares Mean
1211694|NCT00795600|Secondary|Percentage Change in Trunk Lean Mass|Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.|||percent change||Standard Error|Least Squares Mean
1211695|NCT00795600|Secondary|Absolute Change in Trunk Lean Mass|Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
1211696|NCT00795600|Secondary|Percentage Change in Whole Body Lean Mass|Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.|||percent change||Standard Error|Least Squares Mean
1211697|NCT00795600|Secondary|Absolute Change in Whole Body Lean Mass|Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
1211698|NCT00795600|Secondary|Percentage Change in Whole Body Fat Mass|Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.|||percent change||Standard Error|Least Squares Mean
1211699|NCT00795600|Secondary|Absolute Change in Whole Body Fat Mass|Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
1211700|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.|||grams (g)||Standard Error|Least Squares Mean
1211701|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|ITT analysis set using LOCF is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
1211702|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.|||percent change||Standard Error|Least Squares Mean
1211703|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.|||percent change||Standard Error|Least Squares Mean
1211704|NCT00795535|Primary|SDNN: Standard Deviation of the Normal-to-normal R-R Interval|A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.|Upon arrival to the hospital||||milliseconds (ms)||Standard Deviation|Mean
1211705|NCT00795535|Primary|Life Saving Intervention in the Operating Room.|A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
1211707|NCT00795535|Primary|Base Deficit </= -6|Indicator for volume deficit and resuscitation. Number of participants with Base Deficit </= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit </= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
1211708|NCT00795509|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.|||participants|||Number
1211709|NCT00795509|Primary|Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.|||participants|||Number
1211710|NCT00795366|Primary|Time ICP >20|The number of hours that participants remained with intracranial pressure above 20 mmHg|The number of hours during the first 5 days of intracranial pressure monitoring|Intent-to-Treat|||Hours||Standard Deviation|Mean
1211711|NCT00795340|Secondary|Objective Tumor Response as Assessed by RECIST Criteria v1.1.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|ITT|||percentage of participants||95% Confidence Interval|Number
1211712|NCT00795340|Secondary|Progression-free Survival|Medians of PFS and their confidence intervals by arm|at every 3 months visit throughout trial, a median of 12 months|ITT|||months||95% Confidence Interval|Median
1211713|NCT00795340|Primary|Overall Survival|Medians of survival time, and their confidence intervals.|at every 3 months visit throughout trial, a median of 13.1 months.|ITT|||months||95% Confidence Interval|Median
1211714|NCT00795288|Secondary|Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk|Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.|7-10 days after hemorrhage||||ratio||Standard Deviation|Mean
1211715|NCT00795288|Primary|Cerebral Autoregulation During Peak Period of Vasospasm Risk|Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.|7-10 days after hemorrhage||||participants|||Number
1211716|NCT00795288|Primary|Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk|Resting cerebral blood flow during peak period of vasospasm risk measured by PET|7-10 days after hemorrhage|"Of the total population enrolled complete data sets were available on 25. This was due to patient refusal to perform the PET study, logistical difficulties and technical problems.~be completed in seven due to logistical difficulties (n = 4) or patient refusal (n = 3). Two of the completed studies could not be analyzed for technical reasons"|||mL/100 g/min||Standard Deviation|Mean
1211717|NCT00795210|Secondary|Insulin Sensitivity|"insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; M value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given"|after two weeks treatment|Insulin stimulated glucose uptake data were unavailable for 4 subjects in the GH 2mg group. Two subjects did not have sufficient IV access and thus could not complete the clamp procedure. Two subjects did not reach target glucose and thus their data could not be used.|||mg/kg/min||Standard Deviation|Mean
1211718|NCT00795210|Primary|Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug|Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.|after 2 weeks treatment|Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis.|||ng/mL||Inter-Quartile Range|Median
1211719|NCT00795184|Primary|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett’s Esophagus.|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett’s Esophagus.|Centralized histopathology confirmation within 4-6 weeks||||percentage of lesions|Participants|95% Confidence Interval|Number
1211720|NCT00795145|Secondary|Cohort 2: Number of Subjects With AEs and SAEs|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|SAS|||participants|||Number
1211721|NCT00795145|Secondary|Cohort 2: Vss|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||L/kg||Standard Deviation|Mean
1211722|NCT00795145|Secondary|Cohort 2: CL|Drug clearance = Dose / AUC inf|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||mL/min/kg||Standard Deviation|Mean
1211724|NCT00795145|Secondary|Cohort 2: Cmax||Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||ug/mL||Standard Deviation|Mean
1211728|NCT00795145|Primary|Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo|The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia’s formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|The pharmacokinetic (PK) parameter analysis population was defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||milliseconds (msec)|||Number
1211729|NCT00795145|Secondary|Cohort 1: Steady-State Volume of Distribution (Vss)|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||L/kg||Standard Deviation|Mean
1211730|NCT00795145|Secondary|Cohort 1: Clearance of Linezolid (CL)|Drug clearance = Dose / AUC inf|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||mL/minute (min)/kilogram (kg)||Standard Deviation|Mean
1211731|NCT00795145|Secondary|Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||hr||Full Range|Median
1211732|NCT00795145|Secondary|Cohort 1: Maximum Observed Plasma Concentration (Cmax)||predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||ug/mL||Standard Deviation|Mean
1211733|NCT00795145|Secondary|Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last)|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.~AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||microgram (ug)*hours (hr)/mL||Standard Deviation|Mean
1211734|NCT00795145|Primary|Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|Safety Analysis Set (SAS): All subjects who received at least 1 dose of study medication.|||participants|||Number
1211735|NCT00795132|Secondary|Number of Participants Who Experienced Transplantation-related Mortality (TRM)|Cumulative incidence transplantation-related mortality (TRM)|24 months|All incidences of enrolled patients were analyzed.|||participants|||Number
1211736|NCT00795132|Secondary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation.|24 months|All enrolled participants were analyzed.|||probability||Standard Error|Mean
1211737|NCT00795132|Primary|Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments|Assessed donor engraftment in very high risk pediatric patients.|24 months|All enrolled patients were analyzed except for the 3 patients who relapsed or died prior to engraftment.|||participants|||Number
1211738|NCT00795002|Secondary|Disease-free Survival|This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs.|up to 2 years|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy.|||months||95% Confidence Interval|Median
1211739|NCT00795002|Secondary|Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM|Toxicity defined as death from any cause within 60 days of starting FLAM.|60 days|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy. Toxicity defined as death from any cause within 60 days of starting FLAM.|||Participants|||Count of Participants
1211740|NCT00795002|Primary|Complete Response|Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.|1 year|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy|||participants|||Number
1211741|NCT00794963|Primary|Change in Weight||baseline and 8 months|4 participants in usual care arm did not return for follow-up and were not available for analysis; 1 participant in the integrated care group was lost to follow-up|||pounds||Standard Deviation|Mean
1211742|NCT00794924|Secondary|Improvement in Nutritional and Immunological Measurements||45 days|||||||
1211743|NCT00794924|Primary|Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group|Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.|45 days of measuring the outcome|The number of participants was chosen in order to receive a difference by GEE statistical model with > 0.05 p value. The analysis was done per protocol.|||days of constipation or diarrhea||Standard Deviation|Mean
1211744|NCT00794820|Secondary|Overall Survival (OS) Rate|OS was defined as the time from the initiation of treatment to last follow-up date or death. OS were calculated using Kaplan-Meier estimates.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants is not included in analysis, the participant went off study after two months of treatment.|||Percentage of Participants|||Number
1211849|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 6|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211745|NCT00794820|Secondary|Remission Duration/Time to Progression (TTP)|TTP was defined as time from initiation of treatment to primary refractory disease or CLL progression. TTP was censored for therapy-related myelodysplastic syndrome (t-MDS) or acute myelogenous leukemia (t-AML) and death in remission. TTP calculated using Kaplan-Meier estimates.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.|||Months||Full Range|Median
1211746|NCT00794820|Primary|Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months|CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Progressive disease (PD): ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter’s transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, CRi, PR or PD.|6 months|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.|||Percentage of Participants|||Number
1211747|NCT00794677|Other Pre-specified|Percent Change of Non-high Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
1211748|NCT00794677|Other Pre-specified|Percent Change in High Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
1211749|NCT00794677|Other Pre-specified|Percent Change of Low Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
1211750|NCT00794677|Other Pre-specified|Percent Change of Apolipoprotein B||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
1211751|NCT00794677|Other Pre-specified|Log (AUC of Plasma Triglyceride) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, one subject eliminated because the AUC was negative and cannot be log transformed|||Log(mg/dl)||Standard Error|Mean
1211752|NCT00794677|Other Pre-specified|Log (AUC of Plasma Total Cholesterol) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, restricted to changes that were nonnegative because there is no log for a negative number|||Log(mg/dl)||Standard Error|Mean
1211753|NCT00794677|Other Pre-specified|Log(Fasting Plasma Levels of Diet-derived Oxysterols (7-ketocholesterol))||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||Log(mg/dl)||Standard Error|Mean
1211754|NCT00794677|Secondary|Log(Maximal Plasma Concentration (Cmax) of 7-ketocholesterol) After an Oral Bolus|Log Cmax of 7 ketocholesterol after an oral bolus in patients with primary hypercholesterolemia.|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol|||Log(mg/dl)||Standard Error|Mean
1211755|NCT00794677|Primary|Log[Area-under-the-plasma-concentration-curve(AUC) 0-8 Hours 7-ketocholesterol] After an Oral Bolus|Log of Area-under-the-plasma-concentration curve (AUC 0-8hrs) of 7-ketocholesterol after an oral bolus in patients with primary hypercholesterolemia after treatment with ezetimibe versus placebo|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|per protocol|||Log(mg/dl)||Standard Error|Mean
1211756|NCT00794664|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211757|NCT00794664|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1211758|NCT00794664|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211759|NCT00794664|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1211760|NCT00794664|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||ratio||Inter-Quartile Range|Median
1211761|NCT00794664|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1211762|NCT00794664|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211763|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1211764|NCT00794664|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211765|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1211766|NCT00794664|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211767|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1211768|NCT00794664|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211769|NCT00794664|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1211770|NCT00794664|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211771|NCT00794664|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1211772|NCT00794664|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211850|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 3|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211773|NCT00794664|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1211774|NCT00794664|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1211775|NCT00794664|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.|||percentage of baseline||Standard Deviation|Mean
1211776|NCT00794560|Secondary|Patient Satisfaction||at the end of the individual drug therapy, an average of 18 days|||||||
1211777|NCT00794560|Secondary|Compliance|objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).|at the end of the individual drug therapy, an average of 18 days||||percentage of syringes||Standard Deviation|Mean
1211778|NCT00794560|Primary|Drug Use Problems|During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.|during the individual drug therapy, an average of 18 days||||scores on a scale||Standard Deviation|Mean
1211779|NCT00794547|Other Pre-specified|To Correlate the Pharmacokinetic Parameters of Systemic Calcitriol Exposure (AUC) With SNPs of the 24-hydroxylase (CYP24), the Major Vitamin D3 Inactivating Enzyme.||3-6 months|||||||
1211780|NCT00794547|Secondary|Mean AUC 1,25-D3 Concentration at 12 and 24 Hours|The mean AUC (area under the curve) concentrations of 1,25-D3 from 0-12 hours and 0-24 hours will be calculated.|12 and 24 hours post dose|Patients from the phase II portion of the study were included in the pharmacokinetics analysis|||h*ng/mL||Standard Error|Mean
1211781|NCT00794547|Primary|Median Overall Survival|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, overall survival was determined.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.|||months||95% Confidence Interval|Median
1211782|NCT00794547|Primary|Median Time to Progression|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, median time to progression was determined. Progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.|||months||95% Confidence Interval|Median
1211783|NCT00794547|Primary|Number of Participants That Experience Grade 3 or Greater Neutropenia|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. Toxicity was assessed, in part, by noting the number of participants that experience grade 3 or greater neutropenia in each phase of the trial. Toxicities were recorded using NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0 and were followed for 30 days after the date of withdrawal from study drug.|30 days after last dose|Thirty-four patients were enrolled (18 in phase I and 16 in phase II). 16 of 18 patients enrolled in the Phase 1 portion of the study were evaluable for toxicity. One patient in the phase II study went to another therapy prior to the 30 day window for a confirmatory scan and was thus excluded from analysis.|||participants|||Number
1211784|NCT00794547|Primary|MTD of Intravenous Calcitriol When Administered Prior to Fixed Dose Cisplatin 75mg/m2 and Docetaxel 75 mg/m2, Every 3 Weeks in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)|The primary objective was to determine the Maximum Tolerated Dose (MTD) of intravenous calcitriol when administered prior to fixed dose cisplatin 75mg/m2 and docetaxel 75 mg/m2, every 3 weeks in patients with advanced non-small cell lung cancer (NSCLC). Accrual duration for the study is 5 years.|5 years|Eighteen patients were enrolled, and 16 were evaluable for toxicity assessments. Two patients were not evaluable as they progressed prior to completion of cycle 1.|||mcg/m^2|||Number
1211785|NCT00794508|Secondary|Number of Participants Reaching the Normal Range of ADA Enzyme Activity|As measured by ADA enzyme activity in peripheral blood mononuclear cells|2 years||||participants|||Number
1211786|NCT00794508|Secondary|Number of Participants With Greater Than 1% of Gene-Modified Cells in the Peripheral Blood|As measured by quantitative polymerase chain reaction in peripheral blood cells separated into mononuclear and granulocyte fractions.|2 years||||participants|||Number
1211787|NCT00794508|Primary|Number of Participants With Adverse Events|"Examine the safety of the procedure: harvesting bone marrow, isolating CD34+ hematopoietic stem/progenitor cells, performing ex vivo gene transduction with the MND-ADA gamma-retroviral vector, giving 90 mg/m2 busulfan to make space in the bone marrow to aid engraftment, and re-infusing the autologous gene-modified cells."|2 years||||participants|||Number
1211788|NCT00794469|Primary|Baseline Metabolic Rate|baseline metabolic rate|baseline||||kcal/d||Standard Deviation|Mean
1211789|NCT00794469|Primary|Post-drinking Metabolic Rate|resting metabolic rate after drinking water|1 hour||||kcal/d||Standard Deviation|Mean
1211790|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 12|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
1211791|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 8|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
1211792|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 4|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
1211793|NCT00794313|Secondary|Modified Abnormal Involuntary Movement Scale Area Under the Curve|Area under the curve computed for whole body (total) mAIMS (Modified Abnormal Involuntary Movement Scale) scores at each time measurement. This is a commonly utilized scale that is completed by an observer who judges the severity of levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms). All body parts are rated separately on this 0 (none) to 4 (severe – markedly impairs activities) scale. Thus, the total score can range from 0 – 28 with 28 indicating the most severe LID. mAIMS ratings occur as the subject performs the cognitive task while standing on the force plate. mAIMS ratings are made every half hour during the levodopa (LD) dose cycle.|Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)||||Units on a Scale * Hours||Standard Deviation|Mean
1211794|NCT00794313|Primary|Forceplate AUC|Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.|Every 1/2 hour for 8 hour levodopa cycle|triple cross-over study design.|||(meters/second)*hours||Standard Deviation|Mean
1211795|NCT00794196|Secondary|Patient Wellbeing|"Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life.~The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health."|0, 3 and 6 months||||units on a scale||95% Confidence Interval|Mean
1211796|NCT00794196|Primary|Adherence to Antidepressant Medication|Adherence to antidepressant medication was measured through Pharmacy records|At 3 and 6 months||||percentage of adherence patients||95% Confidence Interval|Number
1211797|NCT00794170|Primary|Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)|The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.|Baseline and 12 months|The two treatment groups were compared on change in the percent of adherent patients between baseline and follow-up using a longitudinal logistic regression model fit using a generalized linear model. A p-value less than 0.05 was considered statistically significant. No statistical comparison was done.|||participants|||Number
1211798|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|Prior to last dose at Week 12 (Day 84)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1211799|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 8 (Day 57)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1212668|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in Serum BNP Levels, C-reactive Protein, and Hemoglobin A1c% From Baseline to Follow up||10-14 weeks|||||||
1211800|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 4 (Day 29)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1211801|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 2 (Day 15)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1211802|NCT00794157|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|End of treatment (Week 12 + 1 day, Day 85)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1211803|NCT00794144|Primary|Number of Participants With Anatomic Nasal Exam Abnormalities|The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa|Day 1 (Baseline) to Exit||||Participants|||Number
1211804|NCT00794118|Secondary|Indirect Costs|Indirect costs represent the loss of resources as a consequence of work disability or unemployment.|Baseline, Months 3, 6, 9 and 12||2012-08-31|08/2012||||
1211805|NCT00794118|Secondary|Direct Costs|Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.|Baseline, Months 3, 6, 9 and 12||2012-08-31|08/2012||||
1211806|NCT00794118|Primary|36-Item Short-Form Health Survey (SF-36) at Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
1211807|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 12|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
1211808|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 9|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1211809|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 6|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1211810|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 3|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1211811|NCT00794118|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||minutes||Standard Deviation|Mean
1212669|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in the Number of Circulating Endothelial Progenitor Cells From Baseline to Follow up Exam||10-14 weeks|||||||
1211812|NCT00794118|Primary|Duration of Morning Stiffness at Month 9|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
1211813|NCT00794118|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
1211814|NCT00794118|Primary|Duration of Morning Stiffness at Month 3|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
1211815|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
1211816|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211817|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211818|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211819|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 12|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
1211820|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 9|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211821|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 6|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211822|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 3|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211823|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
1211824|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211825|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211826|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211827|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
1211828|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 9|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211829|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211830|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 3|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1211831|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||mm/hr||Standard Deviation|Mean
1211832|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 9|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
1211833|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
1211834|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 3|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
1211835|NCT00794118|Primary|C-reactive Protein (CRP) at Month 12|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||mg/dL||Standard Deviation|Mean
1211836|NCT00794118|Primary|C-reactive Protein (CRP) at Month 9|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
1211837|NCT00794118|Primary|C-reactive Protein (CRP) at Month 6|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
1211838|NCT00794118|Primary|C-reactive Protein (CRP) at Month 3|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
1211839|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 12|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||cm||Standard Deviation|Mean
1211840|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 9|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211841|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 6|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211842|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 3|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211843|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||cm||Standard Deviation|Mean
1211844|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 9|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211845|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211846|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 3|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1211851|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
1211852|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1211853|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1211854|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1211855|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).|||Percentage of participants|||Number
1211856|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1211857|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1211858|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.|Month 3|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1211859|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
1211860|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|3 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
1211861|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|day 1 postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
1211862|NCT00793910|Secondary|Occurence of Use of Rescue Medication|Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured|2 hours to 4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||# of times rescue meds were used||Standard Deviation|Mean
1211863|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|2 hours postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
1211864|NCT00793871|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead).|Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug)|Safety analysis set included all participants who started study treatment.|||participants|||Number
1211865|NCT00793871|Secondary|Number of Participants With Significant Vital Signs Changes From Baseline|Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) > 100 mm Hg, or SBP > 200 mm Hg and/or DBP > 110 mm Hg; temperature: >38.3 degrees Celsius (degrees C), or increase of greater than or equal to (>=)1.1 degrees C (baseline >=36.8 degrees C); heart rate: >120 beats per minute (bpm) or less than (<) 50 bpm, or increase of >=30 bpm or decrease of ≥30 bpm; respiration rate: > 40 /minute or < 8 /minute; weight: a change of 5% or more from baseline.|Baseline (Day 1) up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
1211866|NCT00793871|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination.|Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
1211867|NCT00793871|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
1211868|NCT00793871|Other Pre-specified|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed.|Baseline (Day 1) to tumor response (up to 82 weeks)|All participants who started study treatment (safety analysis set) had a confirmed objective tumor response.|||weeks||95% Confidence Interval|Median
1211869|NCT00793871|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0.|Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks)|Safety analysis set included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
1211870|NCT00793871|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline (Day 1) up to end of study treatment (up to 276 weeks)|The per-protocol analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started study treatment.|||% of participants||95% Confidence Interval|Number
1211871|NCT00793871|Secondary|Overall Survival (OS)|"OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause.~In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive."|Baseline (Day 1) to death (up to 282 weeks)|Safety analysis set included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
1211872|NCT00793871|Primary|Progression-free Survival (PFS)|PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven’t yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)|Safety analysis included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
1211873|NCT00793819|Primary|Change in Nocturia Episodes||12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||episodes||Standard Deviation|Mean
1211874|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAauc data|||ratio||Geometric Coefficient of Variation|Geometric Mean
1211875|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAcmax data|||ratio||Geometric Coefficient of Variation|Geometric Mean
1211876|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1211877|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1211878|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1211879|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )|PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration [L] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Vz/F,ss data|||L||Geometric Coefficient of Variation|Geometric Mean
1211880|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )|PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration [mL/min] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available CL/F,ss data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1211881|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)|PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available MRTpo,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
1211882|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available t1/2,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
1211883|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available AUCτ,ss data|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1211884|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)|PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmin,ss data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1211885|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available tmax,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
1211886|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmax,ss data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1219729|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 54||Baseline and week 54|Treated Set with values for HbA1c at baseline and week 54. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1211887|NCT00793793|Secondary|PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)|PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1211888|NCT00793793|Secondary|PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)|PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||h||Geometric Coefficient of Variation|Geometric Mean
1211889|NCT00793793|Secondary|PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)|PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1211890|NCT00793793|Secondary|Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period|Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.|from day 1 and up to 4 weeks|TS|||percentage of participants discontinued|||Number
1211891|NCT00793793|Secondary|Occurrence of AEs, by Action Taken With Regard to Study Medication|Occurrence of AEs, by action taken with regard to study medication.|from day 1 and up to 4 weeks|TS|||percentage of participants|||Number
1211892|NCT00793793|Secondary|Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time|Achievement of a >= 2 log10 reduction in plasma HCV RNA level from baseline over time.|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
1211893|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Quantification Over Time|Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
1211894|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Detection Over Time|Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
1211895|NCT00793793|Secondary|Sustained Virologic Response (SVR)|Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).|week 72|FAS|||percentage of responders|||Number
1211896|NCT00793793|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).|week 48|FAS|||percentage of responders|||Number
1211897|NCT00793793|Secondary|Complete EVR2 (cEVR2)|VL below the limit of detection at both 4 weeks and 12 weeks|week 4 and week 12|FAS|||percentage of responders|||Number
1211898|NCT00793793|Secondary|Complete EVR1 (cEVR1)|VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks|week 4 and week 12|FAS|||percentage of responders|||Number
1211899|NCT00793793|Secondary|Early Virologic Response (EVR)|Early Virologic Response (EVR): >=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)|week 12|FAS|||percentage of responders|||Number
1211900|NCT00793793|Secondary|Rapid Virologic Response (RVR)|Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.|week 4|FAS (as randomized)|||percentage of responders||95% Confidence Interval|Number
1211901|NCT00793793|Secondary|Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients|Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised) including patients with available viral load data.|||Log10 IU/mL||Inter-Quartile Range|Median
1211902|NCT00793793|Secondary|Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients|Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised)|||log10 IU/mL||Inter-Quartile Range|Median
1211903|NCT00793793|Primary|Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time|"Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.~ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT)."|Baseline and up to 4 weeks|TS|||participants with grade 3 or 4 abnormal|||Number
1211904|NCT00793793|Primary|Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period|Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|TS|||percentage of participants with SAEs|||Number
1211905|NCT00793793|Primary|Occurrence of Adverse Events (AEs) During BI201335 + Washout Period|Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.|||percentage of participants with AEs|||Number
1211933|NCT00793624|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211906|NCT00793793|Primary|Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)|Efficacy endpoint: VR (virologic response) of >=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).|Baseline and up to 4 weeks|Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.|||percentage of responders||95% Confidence Interval|Number
1211907|NCT00793780|Secondary|Change in Questionnaire on Craving for Sweet or Rich Foods Score|The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.|baseline and week 8||||units on a scale||Standard Deviation|Mean
1211908|NCT00793780|Secondary|LDL Cholesterol|Determined by standard enzymatic procedures|baseline and week 8||||mg/dL||Standard Deviation|Mean
1211909|NCT00793780|Secondary|Insulin Levels|Determined with a double-antibody radioimmunoassay|baseline and week 8||||microIU/mL||Standard Deviation|Mean
1211910|NCT00793780|Secondary|PANSS- Positive and Negative Symptom Scale|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.|8 weeks||||units on a scale||Standard Deviation|Mean
1211911|NCT00793780|Secondary|Fasting Serum Glucose Lab Values||baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
1211912|NCT00793780|Primary|Change in Body Weight From Baseline|Weight was measured with shoes off to the nearest 0.1 kg.|8 weeks||||kg||95% Confidence Interval|Mean
1211913|NCT00793650|Secondary|Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.|"CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.~Partial Response:>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200mg per 24 hour."|100 days after transplant|As per the protocol.|||participants|||Number
1211914|NCT00793650|Primary|Safety and Engraftment|Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.|Day 30 after transplant|As per the protocol|||days||Full Range|Median
1211915|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
1211916|NCT00793624|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.|||percentage of participants|||Number
1211917|NCT00793624|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1211918|NCT00793624|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1211919|NCT00793624|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1211920|NCT00793624|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1211921|NCT00793624|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
1211922|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
1211923|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
1211924|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211925|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211926|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211927|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211928|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211929|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211930|NCT00793624|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211931|NCT00793624|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211932|NCT00793624|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211934|NCT00793624|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS|||Number of puffs||Standard Error|Mean
1211936|NCT00793624|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211937|NCT00793624|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211938|NCT00793624|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211939|NCT00793624|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211940|NCT00793624|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211941|NCT00793624|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
1211942|NCT00793624|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
1211943|NCT00793624|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
1211944|NCT00793624|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
1211945|NCT00793624|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
1211946|NCT00793624|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
1211947|NCT00793624|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
1211948|NCT00793624|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
1211949|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211950|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211951|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211952|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211953|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211954|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211955|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211956|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211957|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211958|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1212584|NCT00789854|Secondary|Change in Beck Depression Inventory (BDI)|Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1211959|NCT00793624|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
1211960|NCT00793624|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
1211961|NCT00793624|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
1211962|NCT00793624|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
1211963|NCT00793624|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
1211964|NCT00793624|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
1211965|NCT00793624|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
1211966|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1212014|NCT00793403|Primary|Patient’s General Health Assessment at Month 12|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1211967|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211968|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211969|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211970|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
1211971|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211972|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211973|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1211974|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1212002|NCT00793455|Secondary|Colorectal Cancer Screening Completion|"We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.~Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|6 months post randomization|Analysis was based on intention to treat.|||participants|||Number
1211975|NCT00793624|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
1211976|NCT00793624|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1211977|NCT00793611|Secondary|Patient Global Impression of Improvement|Outcome measure is only administered at follow-up and used following treatment in patients with urinary incontinence. Measure varies from 1 to 7 on a Likert scale. 1=very much better and 7=very much worse and 4=no change. Thus, lower numbers represent greater improvement.|6-12 weeks after study initiation (@ completion of intervention)|ITT|||units on a scale||Standard Deviation|Mean
1211978|NCT00793611|Secondary|Change in Voiding Frequency Based on Voiding Diary|change in mean number of voids per 24 hours. Each participant recorded voiding frequency every 24 hours for 3 days at baseline and follow-up. A mean number of voids for every patient over 24 hours was calculated at baseline and follow-up.|baseline and 6-12 weeks after study initiation|ITT change in mean number of voids/24 hours|||number of voids per 24 hours||Standard Deviation|Mean
1211979|NCT00793611|Primary|Change in Overactive Bladder Symptoms (Based on OABqSF)|Scale information; Score ranges for oab-qsf quality of life scores range from 13-78; 13=poor quality of life 78=good quality of life. We reported change scores, with larger negative numbers indicating greater improvement in quality of life scores.|baseline and approximately 6-12 weeks after study initiation|ITT|||units on a scale||Standard Deviation|Mean
1211980|NCT00793585|Secondary|The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).||baseline and 6 months|We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique.|||Upro/cr (mg/g)||Standard Deviation|Mean
1211981|NCT00793585|Primary|Change in Renal Function as Measured With eGFR||baseline and 6 months||||eGFR(min/ml)||Standard Deviation|Mean
1211982|NCT00793572|Secondary|OS|Estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.|At 2 years after the autograft||||Participants|||Count of Participants
1211983|NCT00793572|Secondary|Non-relapse Mortality|Confidence intervals will be estimated. Assessed at 200 days and 1 year after allograft.|200 and 365 days after allo||||Participants|||Count of Participants
1211984|NCT00793572|Secondary|Incidence of Toxicities Related to Bortezomib Maintenance Therapy After the Stem Cell Transplantation|Confidence intervals will be estimated.|Up to 100 days after the autograft or allograft||||Participants|||Count of Participants
1211985|NCT00793572|Secondary|Incidence of Chronic GVHD|Confidence intervals will be estimated.|1 year post allo||||Participants|||Count of Participants
1211986|NCT00793572|Secondary|Incidence of Grades II-IV Acute GVHD|Confidence intervals will be estimated.|100 days post allo||||Participants|||Count of Participants
1211987|NCT00793572|Primary|Progression-free Survival|"Confidence intervals will be estimated.~Progressive disease:~Greater than 25% increase in serum (absolute increase must be ≥0.5 g/dL) or urine (absolute increase must be ≥200 mg/24h) M proteins compared to best response status after autologous transplant.~Appearance of new lytic bone lesions or plasmacytomas."|At 2 years after the autograft||||Participants|||Count of Participants
1211988|NCT00793546|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211989|NCT00793546|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211990|NCT00793546|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211991|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) = worst imaginable health state to 100 mm =best imaginable health state; higher scores indicate a better health state.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1212013|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 6|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1211992|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211993|NCT00793546|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211994|NCT00793546|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211995|NCT00793546|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 24 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211996|NCT00793546|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211997|NCT00793546|Secondary|Progression Free Survival (PFS) Based on Investigator|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1211998|NCT00793546|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety population included all participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1211999|NCT00793546|Primary|Progression Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1212000|NCT00793520|Primary|Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.|Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.|Week 0, 5, 7 and 12||||Kg||95% Confidence Interval|Mean
1212001|NCT00793520|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 & 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient’s right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC|Weeks 0, 5, 7 and 12||||Pain Rating||95% Confidence Interval|Mean
1222319|NCT00720499|Secondary|Weekly Mean Morning PEFR|"Weekly mean morning PEFR [L/min] on weeks 1,2,3 and 4.~The presented means are adjusted."|Weeks 1,2,3 and 4|FAS|||Litres / minute||Standard Error|Mean
1212003|NCT00793455|Primary|Colorectal Cancer Screening Completion.|"We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.~Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|3 months post randomization|Analysis was based on intention to treat.|||participants|||Number
1212004|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12|SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212005|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6|SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212006|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 12|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1212007|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 6|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1212008|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 12|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1212009|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 6|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1212010|NCT00793403|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212011|NCT00793403|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212012|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 12|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1212670|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Percentage of Patients With Any of the Following : a) End-systolic or End-diastolic Volume Index Increase >10%; b) Ejection Fraction Decrease >10%; c) E/E'>15 at Follow up||10-14 weeks|||||||
1212015|NCT00793403|Primary|Patient’s General Health Assessment at Month 6|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212016|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212017|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212018|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm/hour||Standard Deviation|Mean
1212019|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm/hr||Standard Deviation|Mean
1212020|NCT00793403|Primary|C-reactive Protein (CRP) at Month 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mg/dL||Standard Deviation|Mean
1212021|NCT00793403|Primary|C-reactive Protein (CRP) at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mg/dL||Standard Deviation|Mean
1212022|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 12|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212023|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 6|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212024|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1212025|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1212026|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1212027|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1212028|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 12|CLARA: index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1212063|NCT00793104|Secondary|International Knee Documentation Committee (IKDC) at 24 Months.|The International Knee Documentation Committee scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months||||units on a scale||Standard Deviation|Mean
1212029|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 6|CLARA: index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1212030|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant’s physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212031|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant’s physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212032|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 12|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212033|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 6|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212034|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1212035|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1212036|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 12|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212037|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 6|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212038|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212228|NCT00791648|Secondary|Number of Participants That Died||until postoperative hospital discharge (about 7 days)||||Participants|||Count of Participants
1212039|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212040|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.~Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Joints||Standard Deviation|Mean
1212041|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.~Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Joints||Standard Deviation|Mean
1212042|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212043|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212044|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212045|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) <=20 millimeter per hour (mm/hr).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212046|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12|Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC <=1; SJC <=1 (TJC, SJC based on 28-joints); CRP <=1 mg/dL; PtGA<=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had SDAI score of <=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA [assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212047|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6|Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(<=)1;swollen joint count(SJC)<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) <=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had Simplified Disease Activity Index score of <=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment [PGA, assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1212048|NCT00793325|Primary|Change in Height SD Score for Calendar Age.|The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.|||standard deviation (SD) score||Standard Deviation|Mean
1212229|NCT00791648|Secondary|Number of Participants With Stroke||while in ICU (about 2 days)||||Participants|||Count of Participants
1212049|NCT00793325|Primary|Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.|Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.|||standard deviation (SD) score||Standard Deviation|Mean
1212050|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).|To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
1212051|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.|To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
1212052|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.|To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
1212053|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications|To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1212054|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1212055|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.|To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1212056|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1212057|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1212058|NCT00793325|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||events|||Number
1212059|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1212060|NCT00793182|Primary|Evaluate the Incidence of Contrast-induced Nephropathy (CIN), Defined as an Increase of ≥ 25% or an Increase of ≥ 0.5 mg/dL From Baseline Serum Creatinine (SCr), Within 48 - 72 Hours After Contrast Administration.||Labs obtained 2-24 hours before and 48-72 hours after contrast administration, with a 7-day follow-up if indicated|There were no subjects with a postcontrast Scr measurement reflecting an increase of ≥25% or ≥0.5 mg/dL from baseline, so no additional blood samples were obtained at 7days (±24 hours) postcontrast. Data were not collected||||||
1212061|NCT00793169|Primary|The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.||6 hours|Analysis was per protocol.|||Participants|||Number
1212062|NCT00793104|Secondary|MRI Evaluation Score|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months||||units on a scale||Standard Deviation|Mean
1212064|NCT00793104|Secondary|Lysholm With Tegner Score|The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.|24 months||||units on a scale||Standard Deviation|Mean
1212065|NCT00793104|Secondary|Current Health Assessment|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0–100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months, MRI only at 12 and 24 months||||units on a scale||Standard Deviation|Mean
1212066|NCT00793104|Primary|The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months||||units on a scale||Standard Deviation|Mean
1212067|NCT00792948|Other Pre-specified|MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry|Correlation between the two measures of MRD measured on the same remission specimens will be examined using scatterplots and correlation analysis. The prognostic effect for relapse of each measure will be illustrated using cumulative incidence plots, and estimated using Cox regression models. This outcome will be reported as funding allows.|Up to 5 years|||||||
1212068|NCT00792948|Other Pre-specified|Overall Survival (OS)|OS will be estimated using the method of Kaplan-Meier.|From the date of initial registration on the study until death from any cause, assessed up to 5 years|Analysis includes eligible patients who received treatment.|||Probability of surviving 12 months||95% Confidence Interval|Number
1212069|NCT00792948|Secondary|Continuous Complete Remission (CCR) Rate|Will be testing using an exact binomial test|18 months|Patients who had not received prior ALL therapy|||percentage of participants||95% Confidence Interval|Number
1212070|NCT00792948|Primary|Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation|Will be estimated using the method of Kaplan-Meier.|12 months|Patients who received allogeneic stem cell transplant|||Probability of 12-month RFS||95% Confidence Interval|Number
1212071|NCT00792935|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|"Hypoglycemic episodes are defined as either a fingerstick glucose~measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia."|Baseline to Week 6|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.|||participants|||Number
1212072|NCT00792935|Primary|Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose|"Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The weighted mean was used to avoid over-representation of post-meal glucose values."|Baseline and Week 6|The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).|||mg/dL||95% Confidence Interval|Least Squares Mean
1212073|NCT00792922|Primary|Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months|"100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia.~50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection.~Outcomes are reported at the community level because raw data could not be accessed.~There is no way to determine how many participants were examined in each arm."|3 years|We analyzed and reported the results of the trial at community level.|||community|community|Standard Deviation|Mean
1212074|NCT00792922|Primary|Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline|"Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years.~The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination."|At baseline|"At baseline 8 communities were randomized to each arm in Tanzania, 12 communities were randomized to each arm in Gambia and Niger.~Stop rule could not be applied in Tanzania.Communities in stop arm were moved to ≥90% coverage or 80%-89% coverage with azithromycin target arm and only main effect of coverage was analyzed in Tanzania."|||community|community|Standard Deviation|Mean
1212075|NCT00792909|Secondary|Number (%) of Subjects With Serious Adverse Events|A serious adverse event (SAE) was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = occurrence of a SAE, regardless of relationship to vaccination.|During the 31-day period following vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1212076|NCT00792909|Secondary|Number (%) of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any = occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post vaccination, with the Synflorix™ vaccine, following the additional dose in the Synflorix group1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1212077|NCT00792909|Secondary|Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/ fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and Fever (rectal temperature ≥ 38.0 °C). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 drowsiness = drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = crying that could not be comforted/ prevented normal everyday activities. Grade 3 loss of appetite = not eating at all. Grade 3 fever = rectal temperature > 40.0°C.|During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1212078|NCT00792909|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed local symptoms were pain, redness and swelling. Any = occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = crying when limb was moved/ spontaneously painful. Grade 3 Redness/ Swelling = Redness/ swelling at injection site greater than (>) 30 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group1 and the Synflorix Group2 and across the 2 doses in the Unprimed Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1212079|NCT00792909|Secondary|Number of Subjects With B-cells Detection in the Unprimed Group|Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post-dose 1.|Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants||Standard Deviation|Mean
1212080|NCT00792909|Secondary|Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2|Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to and 7-10 days post- additional dose.|Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants||Standard Deviation|Mean
1212081|NCT00792909|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group|ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1212082|NCT00792909|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2|ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1212083|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group|Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1212084|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2|Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1212085|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1212230|NCT00791648|Secondary|Liver Enzyme: Aspartate Aminotransferase Level||postoperative day 1||||units/liter||95% Confidence Interval|Median
1212086|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1212087|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1212088|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1212089|NCT00792909|Secondary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1212090|NCT00792909|Secondary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and19A (ANTI-6A and19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1212091|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1212092|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2|Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1212093|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1212094|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.2 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1212095|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1212096|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL..|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+ D7);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1212097|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1212098|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-additional dose at Month 34 in the current study (Month 34)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1212099|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1212100|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1212231|NCT00791648|Secondary|Plasma Markers of Inflammation||at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||2018-07-31|07/2018||||
1212101|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One week after dose 1 (Day 7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1212102|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1212103|NCT00792805|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized to impute missing data.|||Liters||Standard Error|Least Squares Mean
1212104|NCT00792701|Other Pre-specified|Relationship Between RNA and Protein Expression of RRM1 and ERCC1||From time of registration to maximum of 2 years||||Scores||Full Range|Median
1212105|NCT00792701|Other Pre-specified|Generation of Results on in Situ Protein Expression and Other Assays for Genes Involved in Drug Efficacy||From time of registration to maximum of 2 years|Due to lack of funding, the protein expression data were never collected. Thus, this outcome could not be analyzed.||||||
1212106|NCT00792701|Other Pre-specified|Analytical Performance of the Biomarker Assay||From time of registration to maximum of 2 years|Due to lack of funding, the assay was never performed. Thus, this outcome could not be analyzed.||||||
1212107|NCT00792701|Secondary|Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens.|RRM1 and ERCC1 protein levels are expressed as a simple score with no units.|From time of registration to maximum of 2 years|Protein expression relationships were analyzed in the overall patient population, and not by arm.|||Scores||Full Range|Median
1212108|NCT00792701|Secondary|Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0|Patients in the active monitoring arm were not followed for adverse events.|From time of registration to maximum of 2 years|"Number of Subjects With Greater Than Grade 2 Toxicity~Patients in the active monitoring arm were not followed for adverse events."|||participants|||Number
1212109|NCT00792701|Secondary|Two-year Disease-free Survival||From time of registration to maximum of 2 years||||percentage of participants||95% Confidence Interval|Number
1212110|NCT00792701|Primary|Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting|Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.|From time of registration to 84 days after surgical resection.|Percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.|||Participants|||Count of Participants
1212111|NCT00792688|Secondary|Cosmesis/11-point Likert Scale|The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).|At 1 month following the initial treatment.||||scores on a scale||Standard Deviation|Mean
1212112|NCT00792688|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject’s wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.|||days||Standard Deviation|Mean
1212113|NCT00792636|Secondary|Number of Participants Withdrawn From the Study Due to Blood Pressure Changes|The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
1212114|NCT00792636|Secondary|Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||days||Full Range|Median
1212232|NCT00791648|Secondary|Urine Markers of Renal Injury||at randomization, anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, 12 hours postop, and Post op Day (POD) 1, 2, 3.||2018-04-30|04/2018||||
1212115|NCT00792636|Secondary|Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||days||Full Range|Median
1212116|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg|The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
1212117|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study|The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
1212118|NCT00792636|Secondary|Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||participants|||Number
1212119|NCT00792636|Secondary|Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||participants|||Number
1212120|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1212121|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1212122|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1212233|NCT00791648|Secondary|Number of Participants Requiring Dialysis||while in ICU (about 2 days)||||Participants|||Count of Participants
1212123|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1212124|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Deviation|Mean
1212125|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Error|Mean
1212126|NCT00792636|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen|The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home BP assessment. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1212127|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Deviation|Mean
1212128|NCT00792623|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the active phase of the study (up to Month 24)|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered.|||Participants|||Count of Participants
1212129|NCT00792623|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered.|||Participants|||Count of Participants
1212130|NCT00792623|Secondary|Number of Subjects With Any and Related Rash|Rash was assessed as being either associated to the administration site or not. Non administration site rash was presented by following characteristics (with fever, measles/rubella like, varicella like and related).|During the 43-day (Days 0-42) post-vaccination period after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses.|||Participants|||Count of Participants
1212131|NCT00792623|Secondary|Number of Subjects With Any Fever|Any = fever equal to or greater than (≥) 37.5 °C. Grade 3 fever = fever above (>) 39.0 °C. Related = fever assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses.|||Participants|||Count of Participants
1212132|NCT00792623|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Adverse Events|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-vaccination period after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses.|||Participants|||Count of Participants
1212133|NCT00792623|Secondary|Anti-varicella Antibody Titers|Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).|At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects. Only those subjects who provided a serum sample at the specified time point (i.e. with anti-VZV antibody assay results available) were included in the analysis.|||Titers||95% Confidence Interval|Geometric Mean
1212134|NCT00792623|Secondary|Number of Seropositive Subjects for Anti-varicella Antibodies|The seropositivity cut-off titer of the assay was an anti-VZV antibody titer greater than or equal to (≥) 1:4.|At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects. Only those subjects who provided a serum sample at the specified time point (i.e. with anti-VZV antibody assay results available) were included in the analysis.|||Participants|||Count of Participants
1212135|NCT00792623|Secondary|Number of Subjects With a Varicella Vaccine Response|Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer.|At 6.5 months post-transplantation = 2 months post first dose of vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-VZV antibodies for Month 6.5 time point were available.|||Participants|||Count of Participants
1212136|NCT00792623|Primary|Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers|Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).|At 8 months post-transplantation = 1.5 months post-second dose of vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-VZV antibodies for Month 8 time point were available.|||Titers||95% Confidence Interval|Geometric Mean
1212137|NCT00792623|Primary|Number of Subjects With a Varicella Vaccine Response|Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer.|At 8 months post-transplantation = 1.5 months post-second dose of vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-varicella zoster virus (VZV) antibodies for Month 8 time point were available.|||Participants|||Count of Participants
1212138|NCT00792610|Primary|Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)|The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.|7 months||||participants|||Number
1212139|NCT00792428|Secondary|Wolf-Motor-Function-Test|"The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task, or similar as accurate. The average time in seconds is then log10 transformed."|Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days||||units on a scale (log(sec))||Standard Deviation|Mean
1212140|NCT00792428|Primary|Fugl-Meyer Assessment of Upper Extremity Motor Impairment|This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.|Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days||||units on a scale [0-66]||Standard Deviation|Mean
1212141|NCT00792298|Post-Hoc|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Period 1 (To Exclude Carryover Effect)|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. In order to evaluate the efficacy of suvorexant on LPS excluding the influence of a carryover effect from Period 1 to Period 2, an ad hoc analysis of LPS restricted to Period 1 data was also performed.|Night 1 (Period 1 only) and end of Week 4 (Period 1 only)|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
1212142|NCT00792298|Secondary|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
1212143|NCT00792298|Secondary|LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2|WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
1212144|NCT00792298|Primary|LS Mean Sleep Efficiency (SE) During Periods 1 and 2|SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||percent of time in bed||Standard Error|Least Squares Mean
1212145|NCT00792259|Primary|Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device|"The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.~Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer"|30 Minutes||||µm||Standard Deviation|Mean
1212146|NCT00792116|Primary|Math Grades||14 week (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||average percentage correct||Standard Deviation|Mean
1212147|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS).|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|14 weeks (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||percentile||Standard Deviation|Mean
1212148|NCT00792116|Secondary|State Anxiety Scores on the State Trait Anxiety Index for Children (STAIC).|The STAIC is a scale that distinguishes between a situationally based anxiety and a general intrinsic inclination towards experiencing feelings of anxiety|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
1212149|NCT00792116|Secondary|Scores on the Math Anxiety Rating Scale for Adolescents (MARS-A)|he MARS-A (12) is a 98-item scale that lists various everyday situations in which adolescents may have to use mathematics.|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
1212150|NCT00792116|Secondary|Math Scores on the Woodcock Johnson III Tests of Achievement (WJ-III)|The WJ-III (10) is a standardized test battery used to assess an individual’s academic strengths and weaknesses. For purposes of the current study, students were given the 4 math subtests of the WJ-III.|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
1212151|NCT00792116|Primary|Math Grades||baseline (the beginning of a school semester )|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||average percentage correct||Standard Deviation|Mean
1212152|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS)|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|the beginning of a school semester|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||percentile||Standard Deviation|Mean
1212153|NCT00792103|Secondary|Photophobia Free|Photophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participant|||Number
1212154|NCT00792103|Secondary|Phonophobia Free|Phonophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
1212155|NCT00792103|Secondary|Nausea Free|Nausea free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
1212156|NCT00792103|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch activation|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea).|||scores on a scale|Participants|Standard Deviation|Mean
1212157|NCT00792103|Secondary|Pain Relief|Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
1212158|NCT00791999|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
1212234|NCT00791648|Primary|Number of Participants With Delirium||while in ICU (about 2 days)||||Participants|||Count of Participants
1212159|NCT00791999|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
1212160|NCT00791973|Secondary|Total Eye Symptom Scores After Antigen Challenge|Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe|After one week of treatment wtih veramyst or placebo||||units on a scale||Inter-Quartile Range|Median
1212161|NCT00791973|Primary|Change in Tryptase Level From Baseline to Post-antigen Challenge|Tryptase levels (mcg/L) were measured from nasal lavages|After one week of treatment wtih veramyst or placebo||||mcg/L||Inter-Quartile Range|Median
1212162|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|10 weeks|The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.|||scores on a scale||Standard Deviation|Mean
1212163|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 year|The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.|||scores on a scale||Standard Deviation|Mean
1212164|NCT00791934|Secondary|Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg|Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of > 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).|10 weeks post-procedure|The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.|||participants|||Number
1212165|NCT00791934|Secondary|Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)|The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.|10 weeks post surgery|The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.|||participants|||Number
1212166|NCT00791934|Primary|Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.|The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.|10 weeks post-procedure|A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.|||scores on a scale||Standard Deviation|Mean
1212167|NCT00791921|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
1212168|NCT00791921|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
1212169|NCT00791908|Primary|Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters|Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).|Baseline and 3 months||||Units on a scale||Full Range|Mean
1212170|NCT00791817|Primary|Cmax|Maximum plasma concentration after a single dose|over 12 hours||||ng/mL||Standard Deviation|Geometric Mean
1212171|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1212172|NCT00791778|Other Pre-specified|EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1212173|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1212174|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1212175|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1212176|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1212177|NCT00791778|Other Pre-specified|EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
1212178|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1212179|NCT00791778|Other Pre-specified|EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1212180|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1212181|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1212182|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1212183|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1212184|NCT00791778|Other Pre-specified|EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
1212185|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1212186|NCT00791778|Other Pre-specified|FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1212187|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1212188|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1212189|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1212190|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1212191|NCT00791778|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 1 (4 weeks per Cycle)/baseline|Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
1212192|NCT00791778|Secondary|Overall Survival (OS)|The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).|From randomization of the first patient until 32.5 months later|FAS=all randomized participants|||Days||95% Confidence Interval|Median
1212193|NCT00791778|Secondary|Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level|Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Per protocol set (PPS)=all randomized participants who had normal CA-125 serum level at baseline and at least one post-baseline CA-125 assessment|||Days||95% Confidence Interval|Median
1212194|NCT00791778|Primary|Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment|Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Full analysis set (FAS)=all randomized participants|||Days||95% Confidence Interval|Median
1212195|NCT00791765|Secondary|Patient Satisfaction With Treatment at Week 12|This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from “very dissatisfied” to “very satisfied”) to indicate his or her level of satisfaction with the medication’s control of psoriasis.|12 Weeks|Intention-to-Treat with available data at week 12; last observation carried forward (LOCF) imputation was used.|||participants|||Number
1212196|NCT00791765|Secondary|Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12|Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation.|||Percent change||Standard Error|Mean
1212197|NCT00791765|Secondary|Percentage of Participants With PSSI 75% Response at Week 12|Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.|Baseline and Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
1212198|NCT00791765|Primary|Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12|The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 12|Intention-to-Treat population (all patients who were randomized to investigational product) with available data; last observation carried forward (LOCF) imputation was used.|||Percent change||Standard Error|Mean
1212199|NCT00791700|Secondary|Optimized Background Treatment (OBT) Susceptibility Scores (Net/Overall) by Outcome|Outcome (Response, PDVF or other/remainder) was summarized by the total ARV activity of the background regimen using simple and weighted totals (TOBT and p-wTOBTss, respectively) in the aggregate, categorized as 0, 1, ≥2 (TOBT) and 0 0.5, 1 1.5 and ≥2 (p-wOBTss) respectively, as well as by screening genotype. Six participants (Response: n=5; Other failure: n=1) failed to have successful PhenoSense GT analysis at screening, and so a net susceptibility score was not generated. One more participant was not included in the wOBTss analysis due to failed phenotype analysis. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores include: 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance.|48 weeks|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Percentage of participants|||Number
1212200|NCT00791700|Secondary|Summary of the Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF: Total and by Cohort Prior to Week 48|Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Participants with more than one mutation are counted more than once.|48 weeks|"The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).~One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment."|||Number of participants|||Number
1212201|NCT00791700|Secondary|Shift Table of Viral Tropism Between Screening and Confirmed PDVF Prior to Week 48|Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. A shift table of the change in detected tropism from screening to the time of failure was produced in the aggregate and also broken down by age cohort.|Screening and Week 48|Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment.|||Number of participants|||Number
1212202|NCT00791700|Secondary|Protocol Defined Virologic Failure|"The occurrence of any one of the following criteria would constitute Virologic failure:~A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days."|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Number of participants|||Number
1212203|NCT00791700|Secondary|Change From Baseline in CD4+ Percent (%) at Weeks 24 and 48|Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.|||percentage of CD4+ cells||Standard Deviation|Mean
1212204|NCT00791700|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48|Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.|||cells/mm^3||Standard Deviation|Mean
1212205|NCT00791700|Secondary|Summary of Change From Baseline in HIV-1 RNA (Log10 Copies/mL) by Visit|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.|||Log10 Copies/mL||Standard Deviation|Mean
1212206|NCT00791700|Secondary|Summary of Change From Baseline in HIV-1 RNA (Original) by Visit|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.|||copies/mL||Standard Deviation|Mean
1212235|NCT00791648|Primary|Number of Participants With Acute Kidney Injury||postoperative day 2||||Participants|||Count of Participants
1222373|NCT00720330|Secondary|Time From the End of Surgery to Readiness for Hospital Discharge.||Until hospital discharge, assessed up to 6 months||||hours||Standard Deviation|Mean
1212207|NCT00791700|Secondary|Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48|Percentage of subjects with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). Last Observation Carried Forward (LOCF) was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
1212208|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48|TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Percentage of participants|||Number
1212209|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This will be referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. The proportion of participants (100*n/N) is reported below. The proportion of participants (100*n/N) is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Percentage of participants||95% Confidence Interval|Number
1212210|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This will be referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. The proportion of participants (100*n/N) is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Percentage of participants||95% Confidence Interval|Number
1212211|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <48 Copies/mL Through Week 48 (MSDF)|The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The percentage of participants is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||percentage of participants|||Number
1212212|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <400 Copies/mL Through Week 48 (MSDF)|The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The percentage of participants is reported below.|Week 24 and Week 48 post-treatment.|The FAS will consist of all participants who receive at least one dose of study medication (same as APS4).|||percentage of participants|||Number
1212213|NCT00791700|Primary|Treatment Discontinuation Secondary to Serious Adverse Event (SAE) Related to Study Drug|The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||participants|||Number
1212214|NCT00791700|Primary|Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events (All Causality)|Safety was assessed by spontaneous reports, physical examination and laboratory test results in all participants who received at least 1 dose of study drug. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs.|48 weeks|Safety analysis was performed on all participants who received at least 1 dose of study drug.|||Number of events|||Number
1212215|NCT00791700|Primary|PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - Tmax (Time at Maximum Concentration)|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters (Tmax) at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Correlations between MVC PK and efficacy as well as compliance were also assessed.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of APS 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.|||hr||Full Range|Median
1212216|NCT00791700|Primary|PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - AUCtau (Area Under the Curve at Steady State)|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters (AUCtau) at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Correlations between MVC PK and efficacy as well as compliance were also assessed.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of APS 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1212236|NCT00791557|Primary|The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease|Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.|Week 26|Subjects who completed all required transfusions of infliximab were analyzed.|||participants|||Number
1212217|NCT00791700|Primary|Pharmacokinetic (PK) Parameters for Participants With Data in Stage 1 Enrolled in Stage 2 – Week 48|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of Analysis Population Set [APS] 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1212218|NCT00791661|Secondary|24-hour Weighted Mean Glucose (WMG) Concentration|Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.|Up to 36 hours|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||mg/dL||95% Confidence Interval|Least Squares Mean
1212219|NCT00791661|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|up to approximately 17 days|Participants who received study drug. The same participant may appear in more than one treatment arm.|||participants|||Number
1212220|NCT00791661|Secondary|Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006|The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||hours||Standard Deviation|Mean
1212221|NCT00791661|Secondary|Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||hours||Full Range|Median
1212222|NCT00791661|Secondary|Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM||Standard Deviation|Mean
1212223|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006|AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM*hr||Standard Deviation|Mean
1212224|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006|AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM*hr||Standard Deviation|Mean
1212225|NCT00791661|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)|Participants who received study drug. The same participant may appear in more than one treatment arm.|||participants|||Number
1212226|NCT00791648|Secondary|Mitochondrial Function|mtDNA copy number, lactate / pyruvate ratio, PGC-1alpha RNA expression|at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||2018-07-31|07/2018||||
1212227|NCT00791648|Secondary|Plasma and Urine Markers of Oxidative Stress (f2-Isoprostanes, Isofurans)||at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||2018-07-31|07/2018||||
1212237|NCT00791518|Secondary|Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups|The number of participants with the indicated affected medical conditions were counted.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1212238|NCT00791518|Secondary|Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||puffs||Standard Error|Mean
1212239|NCT00791518|Secondary|Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||puffs||Standard Error|Mean
1212240|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1212241|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1212242|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1212243|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1212244|NCT00791518|Secondary|Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <50% and >=50% predicted|||points on a scale||Standard Error|Mean
1212245|NCT00791518|Secondary|Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <80% and >=80% percent predicted|||points on a scale||Standard Error|Mean
1212246|NCT00791518|Secondary|Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios|The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).|Day 1 of a 1-day study|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||participants|||Number
1212247|NCT00791518|Secondary|Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||percentage of participants|||Number
1212248|NCT00791518|Primary|Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||percentage of participants|||Number
1212249|NCT00791492|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included participants who received at least one dose of study medication.|||participants|||Number
1212289|NCT00791336|Secondary|Safety and Tolerability of the Combined Treatment Regimen||7 weeks|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).||||||
1212250|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Holter Monitor Findings|Clinically significant Holter monitor findings included: atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (<30 beats), sustained ventricular tachycardia (>= 30 beats), sinus pause (RR >2.0 second, where RR=60/heart rate), ventricular premature contractions.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.|||participants|||Number
1212251|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.|||participants|||Number
1212252|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Echocardiography (ECHO) Findings|Clinically significant ECHO findings included: LV posterior wall thickness greater than or equal to (>=)13 mm, LV septal thickness >= 13 mm, right ventricular thickness >= 7 mm, ratio of peak mitral early diastolic and atrial contraction velocity (E/A ratio) >= 2, prime septal (E/E) >15, ejection fraction < 50 percent (%), E deceleration time <= 150 millisecond (ms), isovolumic relaxation time (IVRT) <= 70 ms, any valve thickening (> trace regurgitation in mitral, aortic, pulmonary, or tricuspid valves), abnormal respiratory variation of inferior vena cava, pericardial effusion.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||participants|||Number
1212253|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to Grade 3|AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.|||participants|||Number
1212254|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|An Adverse Event (AE) was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug, up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.|||participants|||Number
1212255|NCT00791492|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1212256|NCT00791492|Secondary|Intraepidermal Nerve Fiber (IENF) Density|IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. It is used in diagnosing various neuropathic conditions.|Baseline|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||fibers/mm||Standard Deviation|Mean
1212257|NCT00791492|Secondary|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 6, Month 3, 6 and 12|NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||picogram/milliliter (pg/mL)||Full Range|Median
1212258|NCT00791492|Secondary|Change From Baseline in Troponin I Concentration at Week 6, Month 3, 6 and 12|Troponin I was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular [LV] wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||nanogram/milliliter (ng/mL)||Full Range|Median
1212259|NCT00791492|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6 and 12|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
1212260|NCT00791492|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6 and 12|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1212261|NCT00791492|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6 and 12|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1212262|NCT00791492|Secondary|Change From Baseline in Norfolk Quality of Life – Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptoms present, 0=symptoms absent. Item 8-35:scored on 5-point Likert scale: 0=no problem,4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment,for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1212263|NCT00791492|Secondary|Change From Baseline in Neuropathy Impairment Score - Lower Limb (NIS-LL) Score at Month 6 and 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1212264|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1212265|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1212266|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 12|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1212290|NCT00791336|Secondary|Characterization of Overall and Disease-free Survival||long-term|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).||||||
1212267|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 6|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1212268|NCT00791479|Secondary|Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 8 weeks, 12 weeks|Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams [mg]) with evaluable pharmacokinetic data.|||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
1212269|NCT00791479|Secondary|Antibody Production and Effects to LY2189265|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 4 weeks, 12 weeks, 16 weeks|Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.|||participants|||Number
1212270|NCT00791479|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have body weight change from baseline data available.|||kilogram (kg)||Standard Error|Least Squares Mean
1212271|NCT00791479|Secondary|Treatment Emergent Adverse Events|A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug.|||participants|||Number
1212272|NCT00791479|Secondary|Rate of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.|||Events per participant per year||Standard Error|Least Squares Mean
1212273|NCT00791479|Secondary|Number of Participants With Self-reported Hypoglycemic Events|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.|||participants|||Number
1212274|NCT00791479|Secondary|Change From Baseline in Blood Pressure (BP)|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood pressure change from baseline data available.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1212275|NCT00791479|Secondary|Change From Baseline in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have pulse rate change from baseline data available.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1212276|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Heart Rate|Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have heart rate change from baseline data available.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1212277|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.|||millisecond (msec)||Standard Error|Least Squares Mean
1212278|NCT00791479|Secondary|Change From Baseline in Insulin Sensitivity (HOMA2-%S)|Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.|||percentage of HOMA2-%S||Standard Error|Least Squares Mean
1212279|NCT00791479|Secondary|Change From Baseline in Beta-cell Function (HOMA2-%B)|Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
1212280|NCT00791479|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1212281|NCT00791479|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.|12 weeks|Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.|||percentage of participants|||Number
1212282|NCT00791479|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1212283|NCT00791479|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.|Baseline, 4 weeks, 8 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1212284|NCT00791479|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1212285|NCT00791388|Primary|t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14|t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14|over a Dosing Interval (τ = 12 Hours) on Day 14||||hours||Standard Deviation|Mean
1212286|NCT00791388|Primary|Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14|the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14|12 Hours on Day 14||||hours||Standard Deviation|Mean
1212287|NCT00791388|Primary|Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14|Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14|12 hours on Day 14||||ng/mL||Standard Deviation|Mean
1212288|NCT00791388|Primary|AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14|the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours|14 days|PG 760564 blood plasma concentrations were not measured for the placebo arm|||ng*h/mL||Standard Deviation|Mean
1212292|NCT00791323|Primary|Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels|The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).|Day 3|Intent to Treat defined as all patients who started the study (randomized) with processed aqueous samples. Two patients in the Ketorolac 0.4% arm did not have aqueous humor samples processed.|||Picograms per milliliter (pg/ml)||Standard Deviation|Mean
1212293|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212294|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212295|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212296|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212297|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212298|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212299|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212300|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212301|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212302|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212303|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212304|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1212305|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
1212306|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
1212307|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
1212308|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
1212309|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
1212310|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2.|||Percentage of Participants|||Number
1212311|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
1212312|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
1212313|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212314|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212315|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212316|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212317|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
1212318|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
1212319|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
1212320|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
1212321|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212444|NCT00790556|Primary|Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14|Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.|Day 14 of each 14-day Treatment Period|Subjects who discontinued were not used in the analysis.|||mg/kg/min||Standard Deviation|Mean
1212322|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212323|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212324|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212325|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212326|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212327|NCT00791258|Secondary|Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212328|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212329|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212330|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212331|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212332|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212333|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212334|NCT00791258|Secondary|Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||mm Hg||Standard Error|Mean
1212335|NCT00791258|Secondary|Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||mm Hg||Standard Error|Mean
1223348|NCT00712270|Primary|QTc Measurement|Information regarding the Outcome Measure being a Primary or Secondary, is unavailable.||Limited data only available for 8 of 21 patients|||milliseconds||Full Range|Mean
1212336|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
1212337|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
1212338|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
1212339|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
1212340|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
1212341|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM – 4PM.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
1212342|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212343|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212344|NCT00791258|Secondary|Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212345|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1212346|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of participants|||Number
1212347|NCT00791258|Secondary|Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||mm Hg||Standard Error|Mean
1212348|NCT00791258|Secondary|Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at lease 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||mm Hg||Standard Error|Mean
1212349|NCT00791258|Secondary|The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks||Baseline to 12 and 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
1212350|NCT00791258|Secondary|The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
1212351|NCT00791258|Primary|The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
1212352|NCT00791128|Secondary|HbA1c Values at 12 Months||12 months||||HbA1c (%)||Standard Deviation|Mean
1212353|NCT00791128|Primary|% of Excess Weight Loss (EWL)|"Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight~% EWL = (baseline excess weight - weight loss) x 100"|12 months||||% excess weight loss||Standard Deviation|Mean
1212354|NCT00791102|Secondary|Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment||15 minutes prior to treatment and 15 minutes post antigen challenges||||L/min||Inter-Quartile Range|Median
1212355|NCT00791102|Primary|Change in Itching Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
1212356|NCT00791102|Primary|Change in Stuffy Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
1212357|NCT00791102|Primary|Change in Runny Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
1212358|NCT00791102|Secondary|Nasal Peak Inspiratory Flow Measurements|The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.|15 minutes after diluent challenge and 15 minutes after each antigen challenge||||L/min||Inter-Quartile Range|Median
1212359|NCT00791102|Primary|Change in Sneezing Symptom|Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||sneezes||Inter-Quartile Range|Median
1212360|NCT00791089|Primary|Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)|Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias with or without antiarrhythmic drug (AAD) therapy as shown in the two lines|6 months||||Participants|||Count of Participants
1212361|NCT00791076|Secondary|Frequency of Hypoglycemia Defined as < 60 mg/dl.||72 hours|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Data, if collected,is unknown since no data are available.||||||
1212362|NCT00791076|Primary|Total Amount of Insulin Administered While on Placebo/PP.|Glucose values and the pattern of glycemic excursions over the 72 hour test period.|2 years|Data was not collected for this outcome measure. The P.I. left the institution and the study was terminated.||||||
1212363|NCT00791037|Secondary|Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)||Up to 2 years|Due to getting regulatory approvals we could only enroll 1 patient in this part of the protocol|||Participants|||Count of Participants
1212364|NCT00791037|Secondary|Development of CD4+ and CD8+ Epitope Spreading|As assessed by the development of immunity to epitopes within the HER2 protein to which the patient was not vaccinated as well as the development of immunity to other breast cancer related tumor antigens.|Up to 2 years||||Participants|||Count of Participants
1212365|NCT00791037|Secondary|Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT||Up to 2 year following the last infusion||||Participants|||Count of Participants
1212366|NCT00791037|Primary|Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0|Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding those listed in Table 4) will be considered excessive toxicity and no further dose escalations will occur.|Up to 4 months after first booster vaccine|The infusion of escalating doses of HER2 specific T cells will be defined as safe if at least 75% of subjects are able to receive all 3 infusions without dose limiting toxicity (DLT)|||participants|||Number
1212367|NCT00790907|Secondary|Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population|||participants|||Number
1212383|NCT00790842|Secondary|Pharmacokinetics of Lenalidomide in Impaired Renal Function|To determine the pharmacokinetics of lenalidomide administration in myeloma patients with impaired renal function (pharmacokinetic analysis will be performed in up to 12 consented Mayo Clinic subjects treated during the Phase II component of the trial (only).|56 months|As only 1 patient was enrolled from Mayo Clinic during the Phase II component of the study, samples were neither collected nor analyzed for this endpoint.||||||
1212368|NCT00790907|Secondary|Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population|||participants|||Number
1212369|NCT00790907|Secondary|Number of Participants With Major PCI-related Procedural Complications|Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.|During PCI procedure: immediately after randomization (approximately 10-75 minutes)|ITT Population|||participants|||Number
1212370|NCT00790907|Secondary|Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
1212371|NCT00790907|Secondary|Number of Participants With Minor Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
1212372|NCT00790907|Secondary|Number of Participants With Major Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
1212373|NCT00790907|Secondary|Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR|ITT Population|||participants|||Number
1212374|NCT00790907|Primary|Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period|The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|Intent-to-Treat (ITT) Population: all randomized participants|||participants|||Number
1212375|NCT00790868|Secondary|Role Functioning|LIFE-RIFT. For this clinician-rated measure, total scores range from 0 to 20, with higher scores indicating greater impairment|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized sample|||units on a scale||Standard Deviation|Mean
1212376|NCT00790868|Secondary|Quality of Life Ratings|Quality of life as assessed by the Q-LES-Q. Scores range from 14-70 for total raw score, higher scores indicate higher quality of life ratings.|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized participants|||units on a scale||Standard Deviation|Mean
1212377|NCT00790868|Secondary|Depression Severity|Depression severity was assessed with the MADRS, with scores ranging from 0 to 60. Higher scores indicate greater depression.|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized participants with panic disorder|||units on a scale||Standard Deviation|Mean
1212378|NCT00790868|Primary|Remission Status|Remission status will be used as the primary categorical outcome variable. The CGI-S was used in determining whether patients met the “CGI-S of 1 or 2” component of the “remission status” criteria (i.e., zero panic attacks and CGI-S of 1 or 2 at endpoint). No values are missing because remission must be confirmed; missing status is assigned to disorder status. Hence results are for the full randomized sample.|Pre-treatment, Post-Treatment, and each follow-up sessions|Full sample of 180 randomized participants|||Participants|||Count of Participants
1212379|NCT00790868|Primary|Panic Disorder Severity Scale (PDSS)|The percent change in PDSS score from baseline to the relevant assessment points is the continuous primary outcome measure. The PDSS consists of seven items, each rated on a 0 to 4 scale (0 denoting none, and higher ratings reflecting greater degrees of symptom severity; for a possible range in scores from 0 to 28). In the tabular data below we present the total scores (sum of items).|baseline, mid-TX, post-TX, follow-up visits 1-4|Seventeen subjects out of 92 (five during treatment and 12 during follow-up, 20% total) in the control group compared to six out of 88 (four during treatment and two during follow-up, 10% total) in the DCS group dropped out.|||units on a scale||Standard Deviation|Mean
1212380|NCT00790855|Secondary|Number of Participants With a Response|A complete response (CR) is defined as normalization of the bone marrow and peripheral blood counts with </= 5% marrow blasts in a normo-or hypercellular marrow, with a granulocyte count of >/= 10^9/L and a platelet count of >/=100 X 10^9/L. A partial response (PR) was defined as for CR, but with only >/=50% reduction of marrow blasts and to a range of 6%-25%. A marrow complete response was defined as a reduction of marrow blasts to </=5% but without recovery of peripheral counts.|1 - 24 week cycles (up to 8 weeks)||||participants|||Number
1212385|NCT00790842|Secondary|Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient|The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.|56 months|All patients who started treatment|||participants|||Number
1212386|NCT00790842|Secondary|Duration of Response|Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.|56 months|Patients treated at the recommended phase II dose who experienced a response to treatment|||Months||Inter-Quartile Range|Median
1212387|NCT00790842|Secondary|Overall Survival Time|Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.|56 months|Eligible, treated patients|||months||90% Confidence Interval|Median
1212388|NCT00790842|Primary|Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]|Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components|56 months|Patients treated at the recommended phase II dose|||percentage of participants||90% Confidence Interval|Number
1212389|NCT00790842|Primary|Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy|"Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:~Grade 3 or higher neutropenia with fever ≥38.5 degrees C~Grade 4 neutropenia ≥7 days~Grade 4 or higher thrombocytopenia~Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause"|First cycle of therapy (28 days)|Patients treated during the dose finding phase of the study|||Participants|||Count of Participants
1212390|NCT00790803|Secondary|Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy|No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy.|32 weeks||||participants|||Number
1212391|NCT00790803|Secondary|A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye|"The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye.~In uveitis, severely inflamed vessels leak protein which clouds the normally clear aqueous. This looks hazy with the slit lamp. If severe, it disperses the light beam, causing flare.~White or red blood cells may be observed: the presence of inflammatory cells in the anterior chamber suggests inflammation of the iris and ciliary body.~Blood cells: grading of blood cells in the anterior chamber is as follows:~0 - None.~1+ - faint (barely detectable).~2+ - moderate (clear iris and lens details).~3+ - moderate (hazy iris and lens details).~4+ - intense (fibrin deposits, coagulated aqueous)."|32 weeks||||participants|||Number
1212392|NCT00790803|Secondary|Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT)|Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness.|32 weeks||||participants|||Number
1212393|NCT00790803|Secondary|Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss|Patients best corrected visual acuity was measured at each visit to monitor gain or loss of letters on the EDTRS chart.|32 weeks||||paticipants|||Number
1212394|NCT00790803|Primary|Improvement in VA ETDRS >/= 15 Letters|The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart.|32 weeks|Five consecutive adult patients with non-infectious uveitis associated CME were chosen from the PI's regular medical clinic. Patients demonstrated, on fluorescein angiogram and/or optical tomography, bilateral or unilateral CME with non-infectious uveitis for greater than three months, but less than twelve.|||participants|||Number
1212395|NCT00790790|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 30% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||Time (days)|||Number
1212396|NCT00790790|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (AEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
1212397|NCT00790790|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance was the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.|||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
1212398|NCT00790790|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, followup questions rated the degree to which the issue impaired his/her ability to do work or read.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||participants|||Number
1212399|NCT00790790|Secondary|Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB ECG change >450 milliseconds (msec) was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||participants|||Number
1212400|NCT00790790|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1212401|NCT00790790|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1212402|NCT00790790|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
1212403|NCT00790790|Secondary|Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
1212404|NCT00790790|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212405|NCT00790790|Secondary|Change From Baseline in European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EuroQoL Questionnaire - 5 Dimension (EQ-5D) was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212406|NCT00790790|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicated better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212407|NCT00790790|Secondary|Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks|The Total WOMAC index (pain, stiffness, physical function subscales) was completed by the participant and had 24 questions. Each question was answered using a 5-point Likert scale (0 to 4). The Total score had a range from 0 (none) to 96 (extreme). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212470|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 12 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1224350|NCT00707161|Primary|Response Rate of Melanoma Lesions|Response rate of melanoma lesions was measured after treated with the trial agent.|2005-2010|Study terminated. Analysis not conducted.||||||
1212408|NCT00790790|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represented better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212409|NCT00790790|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I was a scale that measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212410|NCT00790790|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S was a self-reported scale measuring severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessed worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 Weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212411|NCT00790790|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I was a self-reported scale measuring degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessed interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212412|NCT00790790|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212413|NCT00790790|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of night pain and worst pain each day, evaluated as weekly means.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.|||participants|||Number
1212414|NCT00790790|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212415|NCT00790790|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1212416|NCT00790790|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.|||units on a scale||Standard Error|Least Squares Mean
1212471|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 6 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212472|NCT00790335|Secondary|Death|All-cause mortality|Within 24 months after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1212417|NCT00790751|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Error|Least Squares Mean
1212418|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
1212419|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
1212420|NCT00790738|Secondary|Clinical Global Impression Scores|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. At the time of rating patients are rated as: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|8 weeks||||units on a scale||Standard Deviation|Mean
1212421|NCT00790738|Secondary|Clinician-Administered Rating Scale for Mania|The Clinician-Administered Rating Scale for Mania (CARS-M) contains 15 items rated from 0-5 or 0-6 on a Likert scale. It was developed to assess severity of manic symtoms. The scale ranges from 0 to 50, and the following thresholds are used: severe ≥26, moderate 16-25, mild 8-15 and normal ≤7.|8 weeks||||units on a scale||Standard Deviation|Mean
1212422|NCT00790738|Primary|Hamilton Rating Scale for Depression Scores|The Hamilton Rating Scale for Depression (HRSD) is a checklist of items ranked from 0-4 or 0-2, that was designed to measure the severity of depressive symptoms. The scale ranges from 0 to 50, and the following thresholds are used: very severe >23, severe 19-22, moderate 14-18, mild 8-13 and normal ≤7.|8 weeks||||units on a scale||Standard Deviation|Mean
1212423|NCT00790673|Secondary|Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects||16 weeks|||||||
1212424|NCT00790673|Primary|Pharmacokinetic Behavior of CF102 During Repeated Dosing||16 weeks|||||||
1212425|NCT00790673|Primary|Effect of Viral Load||16 weeks|||||||
1212426|NCT00790673|Primary|Adverse Event Profile of Repeated Dosing of CF102||16 weeks||||participants|||Number
1212427|NCT00790647|Secondary|Number of Participants Surviving at 2 Years||2 years from transplant||||Participants|||Count of Participants
1212428|NCT00790647|Secondary|Number of Participants Surviving at 1 Year||one year from transplant||||participants|||Number
1212429|NCT00790647|Secondary|Number of Participants Surviving at 100 Days From Transplant||100 Days from transplant date||||participants|||Number
1212430|NCT00790647|Primary|Number of Participants With Hematologic Response|"complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy <5% plasma cells with no clonal predominance of kappa or lambda isotype.~Partial response: any one of the following~For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells.~For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more.~For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume)."|one year||||participants|||Number
1212431|NCT00790569|Secondary|Change in Cigarettes Per Day|Change in mean cigarettes per day|6-Months||||cigarettes/day||Standard Deviation|Mean
1212432|NCT00790569|Secondary|Reinforcing Effects of Smoking|Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
1212433|NCT00790569|Secondary|Use of Illicit Drugs as Measured by Urine Toxicologies||12 months|Data not collected||||||
1212434|NCT00790569|Secondary|Methadone Dose Changes||12 months|Data not collected||||||
1212435|NCT00790569|Secondary|Retention in Methadone Maintenance||12 months|Data not collected||||||
1212436|NCT00790569|Secondary|Withdrawal Symptoms|Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
1212437|NCT00790569|Secondary|Change in Smoking Urges|Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
1212438|NCT00790569|Primary|CO-confirmed 7-day Abstinence|Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.|12 Months||||participants|||Number
1212439|NCT00790569|Primary|Self-reported 7-day Abstinence|Number of participants with self-reported 7-day abstinence at 12-months|12 Months||||participants|||Number
1212473|NCT00790335|Secondary|Death|All-cause mortality|Within 10 days after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1212445|NCT00790556|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)|"An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body.~Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc.~Drug-relatedness was determined by the investigator based on clinical judgement."|56 days|All 14 subjects enrolled in the study were included in the assessment of safety and tolerability (although only 12 subjects received placebo, our database includes all subjects in the analysis).|||participants|||Number
1212446|NCT00790452|Primary|Frequency of VTE Events|Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.|VTE evaluation with study visits (4 weeks) for up to 2 years|Analysis was to be per protocol, study terminated early with no analysis. Only enrolled participant to the study was prematurely taken off the study due to a drug supply issue.|||participants|||Number
1212447|NCT00790400|Secondary|Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)|Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician’s global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by >=25% or more.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced a best overall skin lesion response CCR or PR.|||months||95% Confidence Interval|Median
1212448|NCT00790400|Secondary|Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.|||months||95% Confidence Interval|Median
1212449|NCT00790400|Secondary|Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|"Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume > 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2.~For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.|||months||95% Confidence Interval|Median
1212450|NCT00790400|Secondary|Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose|C2h values collected 1-3 hours after dose administration on the same study day, at steady state, and patient did not vomit between taking previous dose and blood collection. Samples collected during the first 4 days of dosing will be excluded from all analyses.|2 hours post-dose administration at Weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.|||ng/mL||Standard Deviation|Mean
1212451|NCT00790400|Secondary|Everolimus Trough Concentrations (Cmin)|Cmin values collected prior to dose administration on the same study day and at 20-28 hours after previous dose, at steady state, and patient did not vomit within 4 hours of previous dose. Samples collected during the first 4 days of dosing were excluded from all analyses.|Prior to dosing at weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.|||ng/mL||Standard Deviation|Mean
1212452|NCT00790400|Secondary|Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker|Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.|4 weeks, 12 weeks, 24 weeks, 36 weeks 48 weeks, 60 weeks, 72 weeks|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||pg/mL||Standard Deviation|Mean
1212453|NCT00790400|Secondary|Percentage of Participants With Renal Impairment|Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of <30ml/min/1.73m2.|Day 1 up to 28 days after end of treatment|Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.|||Percentage of Participants|||Number
1212474|NCT00790335|Secondary|Recurrent Venous Thromboembolism|Symptomatic recurrent venous thromboembolism (DVT and/or PE)|Within 24 months after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1212454|NCT00790400|Secondary|Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)|Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician’s Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1212455|NCT00790400|Secondary|Time to Angiomyolipoma Progression as Per Central Radiology Review|"Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2.~For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.|||months||95% Confidence Interval|Median
1212456|NCT00790400|Primary|Angiomyolipoma Response Rate as Per Central Radiology Review|"Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.~For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.|||Percentage of Participants||95% Confidence Interval|Number
1212457|NCT00790335|Secondary|Change in Leg Circumference|Mean calf circumference measured 10 cm below the tibial tuberosity|Baseline to 30 days post-randomization|Modified full analysis set; intention to treat|||centimeters||Standard Error|Mean
1212458|NCT00790335|Secondary|Change in Leg Circumference|Mean calf circumference measured 10 cm below the tibial tuberosity|Baseline to 10 days post-randomization|Modified full analysis set; intention to treat|||centimeters||Standard Error|Mean
1212459|NCT00790335|Secondary|Change in Leg Pain Severity|Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain|Baseline to 30 days post-randomization|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212460|NCT00790335|Secondary|Change in Leg Pain Severity|Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain|Baseline to 10 days post-randomization|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212461|NCT00790335|Secondary|Change in Venous Disease-specific Quality of Life|Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.|Baseline to 24 months post-randomization|Modified full analysis set; intention to treat|||units on a scale||Standard Error|Mean
1212462|NCT00790335|Secondary|Change in General Quality of Life - Mental|Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.|Baseline to 24 months post-randomization||||units on a scale||Standard Error|Mean
1212463|NCT00790335|Secondary|Change in General Quality of Life - Physical|Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.|Baseline to 24 months post-randomization|Modified full analysis set; intention to treat|||units on a scale||Standard Error|Mean
1212464|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 24 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212465|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 18 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212466|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 12 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212467|NCT00790335|Secondary|Venous Clinical Severity Score|Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse|At 6 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212468|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 24 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212469|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 18 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1212478|NCT00790335|Secondary|Major Bleeding|Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).|Within 24 months after randomization|Modified full analysis set; intention-to-treat|||Participants|||Count of Participants
1212479|NCT00790335|Secondary|Major Bleeding|Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).|Within 10 days after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
1212480|NCT00790335|Secondary|Moderate-to-severe Post-thrombotic Syndrome|Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.|Between 6 and 24 months after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
1212481|NCT00790335|Secondary|Any Treatment Failure|Composite of PTS and major non-PTS treatment failure|Through 24 months|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1212482|NCT00790335|Secondary|Major Non-post-thrombotic Syndrome Treatment Failure|A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.|Through 24 months|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1212483|NCT00790335|Primary|Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)|Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.|Between 6 and 24 months after randomization|Modified full analysis set; intention-to-treat|||Participants|||Count of Participants
1212484|NCT00790296|Primary|Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion|1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.|Baseline and 7 hours post study medication infusion||||Scores on a scale||Standard Deviation|Mean
1212485|NCT00790270|Secondary|Resumption of Work or School|number of patients resuming regular activity the day following enrollment.|next day||||participants|||Number
1212486|NCT00790270|Primary|Use of Rescue Medications|the number of patients taking additional rescue medications beyond the study meds|24 hours|number of patients using additionl anlagesics on the day following enrollment|||participants|||Number
1212487|NCT00790270|Secondary|Time to Resumption of Work||1 week|||||||
1212488|NCT00790270|Primary|Pain||Daily for 1 week|||||||
1212489|NCT00790218|Primary|Maximum Tolarated Dose|The MTD was defined as the highest dose level at which < 2 of 6 patients developed Cycle 1 DLT.|first 28 days (Cycle 1)|||||||
1212490|NCT00790218|Secondary|Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102||Baseline|||||||
1212491|NCT00790218|Secondary|Therapeutic Effect of CF102 in Hepatocellular Carcinoma||Every 2 months|||||||
1212492|NCT00790218|Primary|Repeat-dose Pharmacokinetic Behavior of CF102||1 month|||||||
1212493|NCT00790218|Primary|Dose Limiting Toxicity|Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1|From start of treatment until Day 28 of Cycle 1||||participants|||Number
1212494|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1212495|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent [AHA] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1212496|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1212497|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1212498|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value for the outcome measure.|||g/mol Creatinine||Standard Deviation|Mean
1212581|NCT00789854|Secondary|Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1212499|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||g/mol Creatinine||Standard Deviation|Mean
1212500|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Intent to Treat Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value.|||Percentage of HbA1c||Standard Deviation|Mean
1212501|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Per Protocol Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||Percentage of HbA1c||Standard Deviation|Mean
1212502|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Intent to Treat Population)|Change in renal function based on eGFR using the MDRD method.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants with a baseline value.|||mL/min/1.73 m^2||Standard Deviation|Mean
1212503|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Per Protocol Population)|Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||mL/min/1.73 m^2||Standard Deviation|Mean
1212504|NCT00790205|Secondary|Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1212505|NCT00790205|Secondary|Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1212506|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Intent to Treat Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1212507|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Per Protocol Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1212508|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1212509|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1212510|NCT00790205|Primary|Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1212511|NCT00790205|Primary|Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1212582|NCT00789854|Secondary|Change in Anxiety Measured by Visual Analog Scale (VAS)|Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1212512|NCT00790192|Secondary|Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 (‘normal’, not ill) to 7 (extremely ill).|6-Weeks||||scores on a scale||95% Confidence Interval|Least Squares Mean
1212513|NCT00790192|Primary|Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Week 6|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1212514|NCT00790062|Primary|Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors|The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.|baseline to discharge (2-3 days)||||participants|||Number
1212515|NCT00790062|Secondary|Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus|number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)|Initial hospital discharge (2-3 days or more)||||Participants|||Number
1212516|NCT00790062|Secondary|Number of Subjects With Hospital Stays Greater Than 4 Days|Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge|Initial hospital discharge (2 days or more)||||Participants|||Number
1212517|NCT00790062|Secondary|Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)|the number of individuals with a clinically estimated postpartum blood loss of 500cc or more|Initial hospital discharge (2-3 days)||||Participants|||Number
1212518|NCT00790062|Secondary|Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome|the number of individuals with each of the component treatments or individual outcomes in the primary composite.|prior to discharge||||Participants|||Number
1212519|NCT00790062|Secondary|Change in Pre- to Post-delivery Hematocrit (%)|change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)|During delivery hospitalization: Admission hematocrit - post-delivery hematocrit||||hematocrit difference (%)||Inter-Quartile Range|Median
1212520|NCT00790062|Primary|Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage|In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.|Initial hospital discharge (2-3 days)||||participants|||Number
1212521|NCT00790062|Primary|Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment|the number of subjects with any treatment of uterineatony or hemorrhage.|baseline to discharge (2 - 3 days)||||Participants|||Number
1212522|NCT00790036|Secondary|Lymphoma-specific Survival (LSS)|LSS was defined as time from randomization to death as a result of lymphoma.|From randomization to death documented as a result of lymphoma up to 7 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1212523|NCT00790036|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to date of death due to any cause. If the patient was not known to have died, survival was censored at the date of the last contact.|From date of randomization to date of death due to any cause up to around 7 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1212524|NCT00790036|Primary|Disease-free Survival (DFS)|DFS was defined as the time from date of randomization to the date of event defined as the first documented relapse of the disease or death due to any cause. Relapse was based on investigator assessment and was assigned only if: It was documented according to Cheson guidelines by an objective radiological assessment method; It was documented by a biopsy proven lymphoma including new or recurrent bone marrow involvement; A new anticancer therapy for lymphoma started with subsequent confirmation of the relapse within 4 weeks of the start of this anticancer therapy|From date of randomization to the date of event defined as the first documented recurrence of the disease, or death due to any cause and up to 6 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1212525|NCT00790023|Secondary|Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day.|Week 0-2|Intent to Treat Population|||days||Standard Error|Least Squares Mean
1212526|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0|"Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval."|Baseline and up to 48 hours|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212583|NCT00789854|Secondary|Change in Pain, Measured by Visual Analog Scale (VAS)|Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1212527|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)|"Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline.~TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval."|Baseline and up to 36 hours|Intent to Treat Population. Some participants excluded for missing data.|||Units on a scale||Standard Error|Least Squares Mean
1212528|NCT00790023|Secondary|Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0|The RQLQ(S) in impaired subjects (baseline RQLQ[S] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In participants with a Baseline overall score >= 3.0|||units on a scale||Standard Error|Least Squares Mean
1212529|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212530|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212531|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212532|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212533|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212534|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212535|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1224950|NCT00703391|Secondary|Quantitative Sputum Bacteriology|Number of patients with an increase in bacteriological count from Day -1 to Day 15|Pre-dose day -1 to post-dose on day 15||||Participants|||Number
1212536|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212537|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212538|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212539|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212540|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212541|NCT00790023|Secondary|Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212542|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212543|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212544|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212556|NCT00789958|Secondary|2-year Stratum-specific Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1212545|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1212546|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212547|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212548|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212549|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1212550|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population. In participants with a baseline rTOSS >= 5.0|||units on a scale||Standard Error|Least Squares Mean
1212551|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1212552|NCT00790023|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
1212553|NCT00789997|Secondary|Number of Participants With Treatment Failure by 90 Days Assignment|In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group.|Day 0 to Day 90||||participants|||Number
1212554|NCT00789997|Primary|Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 was obtained using calibrated spirometers at approximately the same time of day at all visits throughout the study. The highest acceptable FEV1 and the highest FVC measurement each obtained on any of three blows (even if not from the same curve) meeting the American Thoracic Society criteria constituted the data for that test set.~Not all participants had Day 14 FEV1 measures collected"|Day 0 to Day 14||||percentage of change in FEV1||Standard Error|Mean
1212555|NCT00789958|Secondary|2-year Overall Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1212557|NCT00789958|Secondary|2-year Disease-free Survival in All Patients|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1212558|NCT00789958|Secondary|2-year Stratum-specific Disease-free Survival|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1212559|NCT00789958|Secondary|2-year Overall Survival for All Patients|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1212560|NCT00789958|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
1212561|NCT00789958|Primary|Stratum-specific (R0 and R1) 2-year Overall Survival|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1212562|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212563|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212564|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212565|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212566|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212579|NCT00789854|Secondary|Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4|Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement)|6 weeks of treatment||||MADRS item 4 score||Standard Error|Least Squares Mean
1212580|NCT00789854|Secondary|Change in Anxiety Measured by STAI, Trait Anxiety Inventory|Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1212567|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212568|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212569|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212570|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1212571|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 week of treatments||||Participants|||Number
1212572|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 weeks of treatment||||Participants|||Number
1212573|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221).|6 weeks of treatment||||Participants|||Number
1212574|NCT00789854|Secondary|Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)|Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1212575|NCT00789854|Secondary|Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility|Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1212576|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component|Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1212577|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component|Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1212578|NCT00789854|Secondary|Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)|Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1212585|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1212586|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1212587|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), All Patients|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1212588|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
1212589|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
1212590|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
1212591|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment||||Participants|||Number
1212592|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment||||Participants|||Number
1212593|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 week of treatments||||Participants|||Number
1212594|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1212595|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1212596|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure|Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1212597|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure|Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1212598|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients|Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1212599|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1212600|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks treatment|Analysis was 'per protocol'. Exclusion reason from analysis: Violation of exclusion/inclusion criteria; Non-compliance regarding prohibited concomitant medication, Total unavailability of MADRS score after randomization, Patient not treated with any dose of study drug after randomization, Non-compliance regarding titration to 300 mg quetiapine/d.|||scores on a scale||Standard Error|Least Squares Mean
1212622|NCT00789802|Secondary|Number of Bleeding Days Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.|Median number of bleeding days observed in women with a LNG-IUC treated with naproxen, estradiol and placebo at 16 weeks.|16 weeks|There 129 women who were randomly assigned to the 3 arms. At 12 weeks of follow up, there were 17 participants lost to follow up. This resulted in a total analysis population of 112 participants.|||days||Full Range|Median
1212623|NCT00789802|Primary|Number of Bleeding and Spotting Days|The median number of bleeding and spotting days reported at 12 weeks.|12 weeks||||DAYS||Full Range|Median
1224951|NCT00703391|Secondary|AZD9668 Sputum Concentrations||Pre-dose day -1 to post-dose on day 14||||nM||Full Range|Geometric Mean
1212601|NCT00789828|Secondary|Percentage of Participants With Renal Impairment During Core Period|Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788*(serum creatinine (micromol/L)^-1.154)*(age^-0.203 )*(0.742, if female)*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR < 30 mL/min/1.73 m^2 and participants with National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported.|Day 1 up to 28 days after end of treatment (Core period)|"The analysis was performed in the SAF population. Here, Number of participants analysed signifies the participants assessed for renal function during the study for each arm, respectively."|||Percentage of participants|||Number
1212602|NCT00789828|Secondary|Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose|The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as <5 ng/mL, 5-10 ng/mL, and >10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ng/mL||Standard Deviation|Mean
1212603|NCT00789828|Secondary|Everolimus Blood Concentration (C2h) at 2 Hours Post Dose|The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as < 20 ng/mL, 20-50 ng/mL, and > 50 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ng/mL||Standard Deviation|Mean
1212604|NCT00789828|Secondary|Duration of Skin Lesion Response in Everolimus Treated Participants|Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by > 25% or more from baseline.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population. Here, “Number of participants analysed” signifies everolimus treated responders with best overall skin lesion response during the core and extension period, respectively.|||months||95% Confidence Interval|Median
1212605|NCT00789828|Secondary|Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score|Skin lesions included hypomelanotic macules, the shagreen patch, periungual or subungual fibromas, facial angiofibromas and/or forehead plaques. Response was evaluated using the Physician’s Global Assessment of Clinical Condition (PGA) on a 7-point scale: Grade 0 = complete clinical response, indicated absence of disease, Grade 1, 2, and 3 = partial response, indicated improvements of ≥ 50% but < 100%, Grade 4, 5 = stable disease, indicated some or no improvements of 25% - < 50% and 6 = progressive disease, indicated worse than at baseline evaluation by > 25%. Response rate was determined for participants with ≥ 1 skin lesion at baseline, defined as the percentage of participants with overall status as complete clinical response or partial response.|End of core period (Week 48), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for skin lesion response during the study for each arm, respectively."|||Percentage of participants||95% Confidence Interval|Number
1212606|NCT00789828|Secondary|Time to SEGA Worsening|Time to SEGA worsening was defined as the time from the start of everolimus to date of the first SEGA worsening. SEGA worsening was defined as either; increase from nadir of ≥ 25% in SEGA volume or unequivocal worsening of non-target SEGA lesions, or appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, or new or worsening hydrocephalus. The median value was not reached in either treatment arm of core period as SEGA worsening was observed in less participants (everolimus - 7 and placebo - 8).|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for time to SEGA worsening during the study for each arm, respectively."|||months||95% Confidence Interval|Median
1212607|NCT00789828|Secondary|Duration of SEGA Response|Duration of SEGA response was defined as time from the date of the first documented SEGA response until the date of the first documented SEGA progression. Duration of SEGA response was evaluated only for participants who achieved a SEGA response. The time to SEGA progression was censored if SEGA progression was not observed before the first to occur out of (i) analysis cut-off date (ii) the date when systemic anti-SEGA medication is started, (iii) the date of a SEGA-related surgery or (iv) the date of death. Since, no case of SEGA progression was observed in core study which resulted in censored duration of SEGA response. Only 5 SEGA responders experienced a SEGA progression in extension period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for SEGA progression during the study for each arm, respectively."|||months||95% Confidence Interval|Median
1212608|NCT00789828|Secondary|Time to SEGA Response|Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population.|||months||95% Confidence Interval|Median
1212609|NCT00789828|Secondary|Time to SEGA Progression|Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here Number of participants analysed signifies the participants assessed for time to SEGA progression during the study for each arm, respectively."|||months||95% Confidence Interval|Median
1212610|NCT00789828|Secondary|Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period|Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was < 18 hours.|Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)|The analysis was performed in the FAS population. Missing values were imputed using last observation carried forward approach for core period while raw count for extension period.|||Seizure frequency||Standard Deviation|Mean
1212611|NCT00789828|Primary|Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response|Participants were assessed for SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilized to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|End of core period (Week 48), and end of extension period (up to 4 years)|The primary analysis was performed in Full Analysis Set (FAS) population, defined as all randomized participants involved in the study.|||Percentage of participants||95% Confidence Interval|Number
1212612|NCT00789815|Secondary|Patients Willing Return if Repeated Bronchoscopy is Indicated.|"Patients were asked their willingness to return for another FB if needed by means of a five-point scale (definitely not, probably not, unsure, probably would, and definitely would return). Both probably would, and definitely would return were defined as patients agreed to return."|After patients recovered orientation and before they leaved the scope room.|Patients who answered the question in the questionnaire after bronchoscopy|||participants|||Number
1212613|NCT00789815|Secondary|The Recovery Time to Ambulation|The recovery time to ambulation defined as the time between finishing flexible bronchoscopy to the moment when patients could walk without assistance.|After the bronchoscopy||||Minutes||Standard Deviation|Mean
1212614|NCT00789815|Primary|The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale|The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).|After patients recovered orientation and before they leaved the scope room.|Patients received intervention completely|||units on a scale||Full Range|Median
1212615|NCT00789815|Secondary|The Recovery Time to Orientation|The time to orientation defined as the time between finishing flexible bronchoscopy to the moment when patients could open their eyes spontaneously, could recall their date of birth, and perform a finger-nose test correctly|After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation||||minutes||Standard Deviation|Mean
1212616|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by Cough|“Procedure interference by cough” was when the bronchoscopist had to stop the procedure temporarily and additional xylocaine spray and/or alfentanil had to be given to stop the cough.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth||||participants|||Number
1212617|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy|“Procedure interference by patients’ movement” was when the bronchoscopist had to stop the procedure temporarily and our assistant had to hold down the irritant patient|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth||||participants|||Number
1212618|NCT00789815|Primary|The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy|The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|patients completed the whole intervention|||participants|||Number
1212619|NCT00789815|Primary|The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy|The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|Patients completed the whole intervention.|||participants|||Number
1212620|NCT00789802|Secondary|Continuation Rates of the LNG-IUC at the End of the 12 Week Between the 3 Study Groups|To compare continuation rates of the LNG-IUC at the end of the 12 week between the 3 study groups|12 weeks||||Participants|||Count of Participants
1212621|NCT00789802|Secondary|Patient Satisfaction With the LNG-IUC at the End of the 12 Weeks Between the 3 Study Groups.|To compare the level of patient satisfaction with the LNG-IUC at the end of the 12 weeks between the 3 study groups.|12 weeks|There 129 women who were randomly assigned to the 3 arms. At 12 weeks of follow up, there were 17 participants lost to follow up. This resulted in a total analysis population of 112 participants.|||Participants|||Count of Participants
1212665|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in Oxygen Uptake Kinetics From Baseline to Follow up Exam at Submaximal Cardiopulmonary Exercise Test||10-14 weeks|||||||
1212624|NCT00789776|Secondary|Number of Participants Who Experienced Chronic Extensive GVHD|Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.|Up to 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1212625|NCT00789776|Secondary|Number of Subjects Surviving Post-transplant.|Number of subjects surviving post-transplant.|Up to 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1212626|NCT00789776|Primary|Number of Participants Who Experienced Graft Failure|Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts >2 weeks and is refractory to growth factor support.|Day 100|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1212627|NCT00789776|Primary|Number of Non-relapse Participant Mortalities|Defined as death in any patient for whom there has not been a diagnosis of relapse or disease progression.|Day 200|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1212628|NCT00789776|Primary|Number of Participants With Grades III-IV Acute GVHD|"Number of patients who developed acute GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Day 100|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1212629|NCT00789776|Primary|Number of Participants With Relapsed Disease|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|At 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1212630|NCT00789776|Primary|Number of Participants With Dose Limiting Toxicities|Defined as having at least one of the following adverse events, independent of the attribution to the Natural Killer cell infusion: grade IV infusional toxicity (based on the Adapted Common Toxicity Criteria); grade IV regimen-related toxicity (based on Adapted Common Toxicity Criteria); grade IV acute Graft-Versus-Host Disease; non-relapse mortality.|Day 35 (28 days after NK cell infusion)|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1212631|NCT00789750|Secondary|Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||calculation||Standard Error|Least Squares Mean
1212632|NCT00789750|Secondary|Change From Baseline in Fasting C-peptide||Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||ng/mL||Standard Error|Least Squares Mean
1212633|NCT00789750|Secondary|Change From Baseline in Fasting Insulin Levels||Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||µIU/mL||Standard Error|Least Squares Mean
1212634|NCT00789750|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apo B is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1212635|NCT00789750|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)|Apo A-1 is measured in mg/dL|Baseline, Week 24|Intent-to-treat, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1212636|NCT00789750|Secondary|Percent Change From Baseline in Triglycerides (TG)|TG are measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Inter-Quartile Range|Median
1212637|NCT00789750|Secondary|Percent Change From Baseline in Non-HDL-C|Non-HDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1212638|NCT00789750|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|HDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1219730|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 42||Baseline and week 42|Treated Set with values for HbA1c at baseline and week 42. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1212639|NCT00789750|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|LDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last count carried forward|||percentage of change||Standard Error|Least Squares Mean
1212640|NCT00789750|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|TC is measured in milligrams per deciliter (mg/dL)|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1212641|NCT00789750|Secondary|Number of Participants With a Reduction in FPG of >= 30 mg/dL||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
1212642|NCT00789750|Secondary|Number of Participants With a Decrease of >= 0.5 Percent in HbA1c||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
1212643|NCT00789750|Secondary|Number of Participants With a Decrease of >= 0.7 Percent in HbA1c||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
1212644|NCT00789750|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.|Baseline, Week 24|Participants in the intent-to-treat set with values at both baseline and Week 24 with last observation carried forward|||mg/dL||Standard Error|Least Squares Mean
1212645|NCT00789750|Secondary|Number of Participants Achieving an HbA1c Goal of <7.0%||Week 24|Intent-to-treat set, with last observation carried forward|||Participants|||Count of Participants
1212646|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 16||Baseline, Week 16|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
1212647|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 8||Baseline, Week 8|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
1212648|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 4||Baseline, Week 4|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
1212649|NCT00789750|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24||Baseline, Week 24|Intent-to-treat, last observation carried forward|||percent||Standard Error|Least Squares Mean
1212650|NCT00789737|Secondary|Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test|To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1212651|NCT00789737|Secondary|Changes in Apolipoprotein B (apoB)|To assess the effects of Welchol on changes in apolipoprotein B (apoB)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1212652|NCT00789737|Secondary|Changes in Apolipoprotein A-I (apoA-I)|To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1212653|NCT00789737|Secondary|Changes in Triglycerides [TG]|To assess the effects of Welchol on changes in triglycerides [TG]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1212654|NCT00789737|Secondary|Changes in Non-HDL-C|To assess the effects of Welchol on changes in non-HDL-C|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1212655|NCT00789737|Secondary|Changes in High Density Lipoprotein Cholesterol [HDL-C]|To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||md/dL||Standard Error|Least Squares Mean
1212656|NCT00789737|Secondary|Changes in Low Density Lipoprotein Cholesterol [LDL-C]|To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1212657|NCT00789737|Secondary|Changes in Total Cholesterol [TC]|To assess the effects of Welchol on changes in total cholesterol [TC]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1212658|NCT00789737|Secondary|% Subjects With a Decrease in FPG >=30 mg/dL|% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
1212659|NCT00789737|Secondary|% Subjects Achieving an HbA1C Goal of <7.0|% Subjects achieving an HbA1C goal of <7.0 at 24 weeks|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
1212660|NCT00789737|Secondary|% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units|to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
1212661|NCT00789737|Secondary|Change in Fasting Plasma Glucose|to determine changes in Glycemic control after 24 weeks on therapy|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1212662|NCT00789737|Primary|Percent Change in Hemoglobin A1c|change in HbA1c from baseline to Week 24|24 week|Intent to Treat, Last Observation Carried Forward (LOCF) Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage change of hemoglobin A1c||Standard Error|Mean
1212663|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in End-diastolic Volume Indices and Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|||||||
1212664|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in E/E' Ratios and Myocardial Performance (Tei) Indices From Baseline to Follow up Exam at Transthoracic Echo-color-Doppler Cardiac Exam||10-14 weeks|||||||
1212671|NCT00789724|Primary|Difference Between the Anakinra Arm and Placebo Arm in Change in End-systolic Volume Indices From Baseline to Follow up Exam 10-14 Weeks Later at Cardiac Magnetic Resonance Imaging.||10-14 weeks||||mL/m2||Inter-Quartile Range|Median
1212672|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores|The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
1212673|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)|The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
1212674|NCT00789698|Secondary|Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.|The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.|Baseline and 6 Months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
1212675|NCT00789698|Primary|Relapse of Psychotic Symptoms|"Time to relapse will be defined as the earliest occurrence of any of the following:~Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3~rehospitalization for worsening of psychosis~emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate."|12 Months|The population for relapse analyses is the relapse population which consists of those subjects who are enrolled in the present study, demonstrated response to 6 weeks of treatment with either lurasidone or quetiapine XR in study D1050233-NCT 00790192, and who took at least one dose of study medication in the present study.|||participants|||Number
1212676|NCT00789685|Secondary|All Cause Mortality Rate at 6 Months|A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment|6 months following commencement of therapy|Number of patients whose survival status at 6 months was known|||percentage of patients who died|||Number
1212677|NCT00789685|Primary|All Cause Mortality at Day 28|The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment|28 days following commencement of therapy|Patients included in Safety population|||percentage of patients who died|||Number
1212678|NCT00789685|Primary|Clinically Significant Treatment Emergent Events|Treatment-emergent adverse events (TEAEs) in safety population|From first dose up until Day 28|Patients included in Safety population|||Number of patients|||Number
1212679|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa||||letters||Standard Deviation|Mean
1212680|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa||||participants|||Number
1212681|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks||||letters||Standard Deviation|Mean
1212682|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks||||participants|||Number
1212683|NCT00789672|Primary|Tolerability of Study Medication-Adverse Event Reporting|Number of adverse events reported throughout entire study.|24 weeks||||events|||Number
1212684|NCT00789672|Primary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks||||letters||Standard Deviation|Mean
1224952|NCT00703391|Secondary|Sputum Differential Neutrophil Count|Change from baseline to Day 14 in percentage neutrophil count|Pre-dose day -1 to post-dose on day 14||||Percentage||Full Range|Median
1212685|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|10 weeks after stopping levodopa||||letters||Standard Deviation|Mean
1212686|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|10 weeks after stopping levodopa||||participants|||Number
1212687|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|4 weeks after enrollment||||letters||Standard Deviation|Mean
1212688|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|4 weeks after enrollment||||participants|||Number
1212689|NCT00789672|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks||||participants|||Number
1212690|NCT00789672|Primary|Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|9 weeks after starting levodopa||||letters||Standard Deviation|Mean
1212691|NCT00789672|Primary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|9 weeks after starting levodopa||||participants|||Number
1212692|NCT00789581|Secondary|Overall Survival|The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause.|up to 5.25 years (63 months)|The intent-to-treat population (all randomized patients) are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1212693|NCT00789581|Primary|Disease-free Survival|The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.|up to 5.25 years (63 months)|The intent-to-treat population (all randomized patients) are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1212694|NCT00789555|Primary|Self-Rated Relief Assessment at Day 30|"Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief."|Day 30|Analysis population included all subjects enrolled under protocol Version 2.0 who received study drug and attended at least one on-therapy study visit (ITT). The LOCF (last observation carried forward method) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1212695|NCT00789555|Secondary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
1212696|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
1212697|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
1212712|NCT00789373|Secondary|Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)||Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|All randomized participants|||percentage of participants|||Number
1212698|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
1212699|NCT00789555|Primary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|This analysis population includes all subjects who received study drug (Safety Analysis Set), minus any missing data.|||Percentage of subjects|||Number
1212700|NCT00789529|Secondary|Subject Questionnaire Response|"Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.~0=Very poor 50 = Excellent"|2 weeks||||units on a scale||Standard Deviation|Mean
1212701|NCT00789529|Primary|Objective, In-vivo Soft Contact Lens Wettability Index|The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack–Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.|2 weeks|Per protocol. All participants that completed both arms were analysed.|||wettability index||Standard Deviation|Mean
1212702|NCT00789477|Secondary|Number of Focal Laser Treatments||Week 1 to week 48|For the first 24 weeks, the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups did not receive laser treatment. From week 24 onward, participants in the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups were allowed to receive laser rescue treatment.|||Treatments||Standard Deviation|Mean
1212703|NCT00789477|Secondary|Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF|Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52||||microns||Standard Deviation|Mean
1212704|NCT00789477|Secondary|Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF|Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52|FAS|||participants|||Number
1212705|NCT00789477|Secondary|Change in BCVA From Baseline to Week 52 - LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 52|FAS|||letters correctly read||Standard Deviation|Mean
1212706|NCT00789477|Primary|Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|"Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.~Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF)."|At week 24|The FAS was used for the primary efficacy analysis. It included patients as randomized.|||letters correctly read||Standard Deviation|Mean
1212707|NCT00789438|Primary|Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints|Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.|Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay||||SPI and delta SPI (to baseline)||Standard Error|Median
1212708|NCT00789373|Secondary|Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm*100.|Date of randomization to date of measured PD (up to 19.3 months)|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1212709|NCT00789373|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off|Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.|Baseline to date of measured progressive disease (up to 19.3 months)|All randomized participants|||percentage of participants|||Number
1212710|NCT00789373|Secondary|Percentage of Participants With Serious Adverse Events During Maintenance Phase|A summary of serious adverse events is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with all serious adverse events included.|||percentage of participants|||Number
1212711|NCT00789373|Secondary|Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase|A summary of non-serious AEs is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.|||percentage of participants|||Number
1224953|NCT00703391|Secondary|Sputum Absolute Neutrophil Count|Change from baseline to Day 14 in absolute neutrophil count|Pre-dose day -1 to post-dose on day 14||||10**9/L||Full Range|Median
1212713|NCT00789373|Secondary|Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)|Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.|||units on a scale||Standard Deviation|Mean
1212714|NCT00789373|Secondary|Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score|The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.|||units on a scale||Standard Deviation|Mean
1212715|NCT00789373|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.|Date of randomization to the date of death from any cause up to 39.5 months|All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.|||months||95% Confidence Interval|Median
1212716|NCT00789373|Secondary|Independently-assessed Objective Progression-free Survival (PFS)|To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)|Randomized participants with reviewable scan--(316/359 [88%] Maintenance arm and 156/180 [87%] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).|||months||95% Confidence Interval|Median
1212717|NCT00789373|Primary|Investigator-assessed Objective Progression-free Survival (PFS)|Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)|All randomized participants|||months||95% Confidence Interval|Median
1212718|NCT00789321|Secondary|Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2|Least Squares Mean Difference from Baseline|Baseline and 2 weeks|All patients treated with water displacement measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2) – two patients in the amlodipine group were excluded due to technical/procedural errors.|||Grams||Standard Deviation|Least Squares Mean
1212719|NCT00789321|Primary|Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2|Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint.|Baseline and 2 weeks|All patients treated with segmental bioimpedance measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2).|||Ohms||Standard Deviation|Least Squares Mean
1212720|NCT00789256|Secondary|Number of Participants With Correlation Between in Vitro and in Vivo Activity of the Combination of Bortezomib and Melphalan.|Leukemic cells will be collected to test the presence of the study drugs using a cell viability assay in vitro and in vivo.|Pre-treatment and at complete response|No data was collected and these results were not obtained. The collaborating laboratory with the capability to perform the assay with leukemic cells was not available to analyze the samples.||||||
1212721|NCT00789256|Secondary|Determine Safety Profile of the Combination of Bortezomib and Melphalan.|The safety profile is based on the number of adverse events experienced by participants as reported in the Adverse Events results section for this protocol.|Start of treatment through 28 days post-treatment||||Participants|||Count of Participants
1212722|NCT00789256|Primary|Response Rate of the Combination of Bortezomib and Melphalan in Patients With AML and High-risk MDS.|Determine disease response to treatment using Cheson 2000 report of an international working group to standardize response criteria for myelodysplastic syndromes.|Post Cycle 1 through 28 days post-treatment||||participants|||Number
1212723|NCT00789191|Secondary|Self-measured 9-point Plasma Glucose Profile||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||mmol/L||Standard Error|Mean
1212724|NCT00789191|Secondary|Hypoglycemic Episodes: Night Time|Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1212725|NCT00789191|Secondary|Hypoglycemic Episodes: Day Time|Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1224954|NCT00703391|Primary|QTcF|QTcF change from baseline greater than 60 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1212726|NCT00789191|Secondary|Hypoglycemic Episodes|Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1212727|NCT00789191|Secondary|FPG (Fasting Plasma Glucose)||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||mmol/L||Standard Error|Mean
1212728|NCT00789191|Secondary|Change in Body Weight||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||kg||Standard Error|Mean
1212729|NCT00789191|Secondary|Change in BMI (Body Mass Index)||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||kg/m^2||Standard Error|Mean
1212730|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
1212731|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
1212732|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
1212733|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
1212734|NCT00789191|Primary|HbA1c (Glycosylated Haemoglobin A1c)||Week 26|Sample size calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%. FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Percent (%) glycosylated haemoglobin||Standard Error|Mean
1212735|NCT00789113|Primary|Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG|To evaluate the absolute bioavailability of immediate release (IR) and extended release (ER) lamotrigine (LTG) via blood and urine sampling for 24 hour period followed by once a day blood sampling for 3 days following initial dose administration.|1 week||||µg*h/mL||95% Confidence Interval|Geometric Mean
1212736|NCT00789074|Secondary|Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence|"Change in the Mood and Physical Symptoms Scale (MPSS)*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8).~* The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual)."|Week 4 - 8|Participants who were abstinent at 1 week and provided data on withdrawal symptoms|||Scores on a scale||Standard Deviation|Mean
1212737|NCT00789074|Secondary|Change in Pre-quit Cigarette Consumption|Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.|Baseline - week 4|All participants that provided data at each session|||Cigarettes consumed per day||Standard Deviation|Mean
1212738|NCT00789074|Secondary|Change in Pre-quit Ratings of Cigarette Satisfaction|"Satisfaction measured on a scale of 1-5; Have you found your cigarettes more or less enjoyable than usual in the last week? 1= much more and 5 = much less"|Baseline - week 4|Participants who provided ratings of cigarette satisfaction at each visit|||units on a scale||Standard Deviation|Mean
1212739|NCT00789074|Secondary|Change in Pre-quit Cotinine Levels|Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.|Weeks 1-4 (the first 4-weeks after first medication dose)|All participants that provided data at all time points|||ng/ml||Standard Deviation|Mean
1212740|NCT00789074|Secondary|Change in Pre-quit End-expired Carbon Monoxide Reading (CO)|"Carbon monoxide concentration is measured in particles per million. It indicates smoke intake.~CO was measured at each contact to monitor changes in smoke intake and differences between the study arms."|Baseline - week 8|Participants that provided data at all time points|||ppm||Standard Deviation|Mean
1212741|NCT00789074|Primary|Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale|The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.|24 hours and 7 days after quit date (week 4)|Were abstinent and provided data at 24 hours post quit date|||units on a scale||Standard Deviation|Mean
1212742|NCT00789035|Secondary|Trough Concentrations of Empagliflozin in Plasma|Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1212743|NCT00789035|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||kg||Standard Error|Mean
1212744|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU / mmol||Standard Error|Mean
1212745|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L x mmol/L||Standard Error|Mean
1212746|NCT00789035|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L||Standard Error|Mean
1212747|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).|12 weeks|FAS (CLOCF)|||percentage of participants|||Number
1212748|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).|12 weeks|FAS (CLOCF)|||percentage of participants|||Number
1212749|NCT00789035|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS, classical last observation carried forward (CLOCF) was used as the imputation method.|||percentage of HbA1c||Standard Error|Mean
1212750|NCT00789035|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.~Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|FAS (LOCF)|||mg/dL||Standard Error|Mean
1212751|NCT00789035|Primary|Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment|"Change of HbA1c from baseline after 12 weeks of treatment.~Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|The full analysis set (FAS) consists of all randomised patients who were treated with at least 1 dose of study drug and had a baseline measurement of the primary endpoint. Modified last observation carried forward was used as the imputation method (LOCF).|||percentage of HbA1c||Standard Error|Mean
1212752|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Ganitumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1212753|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Ganitumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1212754|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Rilotumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1212755|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Rilotumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1212756|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Panitumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1212757|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Panitumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1212758|NCT00788957|Secondary|Part 1: Area Under the Drug Concentration-time Curve During a Dosing Interval (AUCtau) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.|||day*μg/ml||Standard Deviation|Mean
1212759|NCT00788957|Secondary|Part 1: Maximum Observed Drug Concentration (Cmax) and Minimum Drug Concentration (Cmin) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.|||μg/ml||Standard Deviation|Mean
1212760|NCT00788957|Secondary|Number of Participants With Antibody Formation to Panitumumab, Rilotumumab and Ganitumab|Validated immunoassays were used to detect anti-panitumumab, anti-rilotumumab and anti-ganitumab binding antibodies.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set participants with at least one post-baseline immunoassay result.|||participants|||Number
1212761|NCT00788957|Secondary|Number of Participants With Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).|||participants|||Number
1212770|NCT00788957|Primary|Part 1: Number of Participants With Dose-limiting Toxicities (DLT)|A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator|7 weeks|The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.|||participants|||Number
1212771|NCT00788892|Secondary|Aplasia Rate|Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.|Day 14 (1st Induction)|Efficacy Evaluable Analysis Set|||Participants|||Count of Participants
1212762|NCT00788957|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an AE that is fatal, life threatening (places the participant at immediate risk of death), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. AEs were graded for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. AEs were assessed by the investigator for the relationship of the AE to each one or more of the investigational products by the question: “Is there a reasonable possibility that the event may have been caused by the investigational product?”|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).|||participants|||Number
1212763|NCT00788957|Secondary|Overall Survival|The interval from the first dose of study therapy to the date of death. Participants still alive at the analysis data cutoff date were censored at their last contact date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||months||95% Confidence Interval|Median
1212764|NCT00788957|Secondary|On-treatment Progression-free Survival|An event is defined as a radiographic progression or death that occurred from the first dose to 28 days since the last dose of study therapy. Participants who did not progress or die during this period were censored at their last evaluable disease assessment before the end of the 28-day period. Participants who received Part 3 treatment before 28 days since their last dose of study drug in Part 2 and did not have radiographic progression or die were censored at their last evaluable disease assessment prior to receiving therapy in Part 3. Radiographic progressions after start of a new anti-tumor therapy, including Part 3 treatment, or after 28 days since the last dose in Part 2 were excluded from the analysis. Participants who died with no prior radiographic disease progression during Part 3 treatment, but within the 28-day period since the last dose in Part 2 were considered as having an event.|From the date of first dose until 28 days after the last dose until the data cut-off date of 23 July 2010. Median time on treatment was 3.7, 4.9 and 5.1 months in each treatment arm respectively.|Efficacy analysis set|||months||95% Confidence Interval|Median
1212765|NCT00788957|Secondary|Progression-free Survival|The interval from the first dose of study therapy to the earlier date of disease progression (per modified-RECIST v1.0) or death. Participants who did not progress or die by the analysis data cutoff date were censored at their last evaluable disease assessment date prior to the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 3 where applicable. Participants enrolled into Part 3 or who started a new line of anti-tumor therapy before radiographic progression but subsequently died were considered as having an event with the event date same as the death date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||months||95% Confidence Interval|Median
1212766|NCT00788957|Secondary|Part 2: Percentage of Participants With Disease Control|The percentage of participants with an overall objective response of CR, PR, or stable disease (SD). CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD). SD: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD and no progression of non-target lesions, or the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||percentage of participants||95% Confidence Interval|Number
1212767|NCT00788957|Secondary|Part 2: Time to Response|The interval from the first dose of study therapy to the date of the first confirmed objective response, calculated only for participants with an objective response.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.|||months||95% Confidence Interval|Median
1212768|NCT00788957|Secondary|Part 2: Duration of Response|The interval from the first visit of a confirmed objective response to disease progression as defined by the modified RECIST v1.0 criteria. Participants who did not progress by the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and the start of Part 3 dosing where applicable were censored at their last evaluable disease assessment date prior to the end of reporting period. Progressive disease is defined as at least a 20% increase in the size of target lesions, or unequivocal progression of existing non-target lesions, or any new lesions.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.|||months||95% Confidence Interval|Median
1212769|NCT00788957|Primary|Part 2: Percentage of Participants With an Objective Response|An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.|||percentage of participants|||Number
1212772|NCT00788892|Secondary|Rate of Stem Cell Transplant|The rate of patients who underwent stem cell transplant.|Up to 1 year|Efficacy Evaluable Analysis Set|||Participants|||Count of Participants
1212774|NCT00788892|Secondary|Event Free Survival|Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.|Up to 1 year from randomization|Efficacy Evaluable Analysis Set|||days||95% Confidence Interval|Median
1212775|NCT00788892|Secondary|Remission Duration/Time to Remission|"Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.~Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met."|Following achievement of CR over the study period|Efficacy Evaluable Analysis Set|||days||Full Range|Median
1212776|NCT00788892|Primary|Number of Participants With Complete Remission|Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts.|Within 6 weeks of the last induction treatment|Efficacy Evaluable Analysis Set: All randomized subjects who received at least 1 dose of study drug. One subject who developed Philadelphia chromosome positive disease prior to any efficacy assessment was excluded from the Efficacy Analysis Set.|||Participants|||Count of Participants
1212777|NCT00788775|Secondary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).||||participants|||Number
1212778|NCT00788775|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 16.2 months (90%CI 11.7-17.7 months; no/with CNS mets 16.2m/ 11.7m).|The analysis dataset is comprised of treated patients.|||months||90% Confidence Interval|Median
1212779|NCT00788775|Secondary|Progression-Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).|The analysis dataset is comprised of treated patients.|||months||90% Confidence Interval|Median
1212780|NCT00788775|Primary|4-month Progression-Free Survival Rate|4-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 4 months.|The analysis dataset is comprised of treated patients.|||proportion of patients||90% Confidence Interval|Number
1212781|NCT00788710|Secondary|Average Elicited Pain Upon Sitting Over Days 1 to 3|Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 days|Full analysis set population|||Score on a scale||Standard Error|Least Squares Mean
1212782|NCT00788710|Secondary|Average Total Daily Dose of Morphine Over Days 1 to 3||3 days|Full analysis set population|||milligrams (mg)||Standard Error|Least Squares Mean
1212783|NCT00788710|Primary|Average Pain Intensity at Rest Over Days 1 to 3|Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 Days|Full analysis set population|||Score on a scale||Standard Error|Least Squares Mean
1212784|NCT00788697|Secondary|Inter-reader Agreement|Inter-reader agreement of assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Computation for the percentage agreement within two categories: “3 out of 3 readers agree” and “2 out of 3 readers agree”.|24 hours to 6 months||||Percent of total number of lesions|||Number
1212785|NCT00788697|Secondary|Specific Diagnosis of Benign FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 116 ITD participants with benign lesions based on the truth standard, only 89 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.|||Benign lesions|Benign lesions to be characterized||Number
1212832|NCT00787904|Primary|Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells|(Please note to reviewer, CD3 positivity indicates a T-cell, the title is correct)|2 years||||percentage of CD3 positive cells||Standard Deviation|Mean
1219731|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 30||Baseline and week 30|Treated Set with values for HbA1c at baseline and week 30. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1212786|NCT00788697|Secondary|Specific Diagnosis of Malignant FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 124 ITD participants with malignant lesions based on the truth standard, only 115 participants (lesions) were characterized as either hepatocellular carcinoma (HCC) lesions or metastatic lesions.|||Malignant lesions|Malignant lesions to be characterized||Number
1212787|NCT00788697|Secondary|Negative Predictive Value (NPV): Percentage of True Negative Lesions Among All Malignant Lesions Per Ultrasound|"Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per ultrasound) x 100."|24 hours to 6 months|Among the 240 ITD participants, the overall number of participants (lesions) assessed as benign varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent negative lesions by ultrasound|Negative lesions|95% Confidence Interval|Number
1212788|NCT00788697|Secondary|Positive Predictive Value (PPV): Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound|"Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per ultrasound) x 100."|24 hours to 6 months|Among the 240 ITD participants, the overall number of participants (lesions) assessed as malignant varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent positive lesions by ultrasound|Positive lesions|95% Confidence Interval|Number
1212789|NCT00788697|Secondary|Accuracy: Percentage of True Positive and True Negative Among All Lesions|"The Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive and true negative lesions/number of total lesions per truth standard) x 100."|24 hours to 6 months|240 participants in the ITD population|||Percent true positive and negative lesio|Total lesions|95% Confidence Interval|Number
1212790|NCT00788697|Primary|Specificity: Percentage of True Negative Lesions Among All Malignant Lesions Per Truth Standard|"Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100."|24 hours to 6 months|Among the 240 ITD participants, only 116 participants (lesions) were benign based on the truth standard and were included for specificity.|||Percentage of true negative lesions|Benign lesions|95% Confidence Interval|Number
1212791|NCT00788697|Primary|Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard|"Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs), using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-Diagnose (ITD) population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~Truth standard: contrast-enhanced computed tomography (CE CT) and /or contrast-enhanced magnetic resonance imaging (CE-MRI) examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100."|24 hours to 6 months|Among the 240 ITD participants, only 124 participants (lesions) were malignant based on the truth standard and were included for sensitivity.|||Percentage of true positive lesions|Malignant lesions|95% Confidence Interval|Number
1212792|NCT00788593|Secondary|Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."|||kg/m^2||Standard Deviation|Mean
1212848|NCT00787800|Primary|Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)|An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).|Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.|||Participants|||Number
1212793|NCT00788593|Secondary|Change From Placebo Baseline in Weight at End of Each Treatment Period|Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||kilogram (kg)||Standard Deviation|Mean
1212794|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment|Percent CNA was calculated as [(nitrogen intake - nitrogen excretion)/nitrogen intake]*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least one dose of the study drug. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."|||percent CNA||Standard Deviation|Mean
1212795|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."|||percent CFA||Standard Deviation|Mean
1212796|NCT00788593|Primary|Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods.|3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."|||percent CFA||Standard Deviation|Mean
1212797|NCT00788372|Primary|Brief Pain Inventory-Short Form (BPI-SF) Total Score|The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1212798|NCT00788372|Primary|Participants Overall Assessment|The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1212799|NCT00788372|Primary|Physician’s Global Assessment Scale|The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||participants|||Number
1212800|NCT00788372|Primary|Short-Form 36-Item Health Survey (SF-36) Scores|The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1212801|NCT00788372|Primary|Number of Rescue Treatments|Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||treatments per day||Standard Deviation|Mean
1212849|NCT00787787|Secondary|Median Overall Survival|Survival estimated by Kaplan-Meier method|From start of treatment until death from any cause, assessed up to 3 years||||days||Full Range|Median
1212802|NCT00788372|Primary|Number of Participants With Quality of Sleep|The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1212803|NCT00788372|Primary|Number of Participants With Total Painful Time Per Day|The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1212804|NCT00788372|Primary|Number of Participants With Pain Assessed by Categorical Scale for Pain|Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable).|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1212805|NCT00788372|Primary|Pain Visual Analogue Scale Score|"Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Week 52 or end point (early discontinuation)|Full Analysis Set (FAS) population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||mm||Standard Deviation|Mean
1212806|NCT00788372|Primary|Dependence Questionnaire (DQ)|The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug.|Week 52 or end point (early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale|||Number
1212807|NCT00788372|Primary|Questionnaire of Opioid Withdrawal Symptoms|Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (>) 36 points = severe withdrawal.|Week 52 or endpoint (1 week after last treatment or early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1212808|NCT00788255|Primary|TTG|thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)|6 months||||mm||Standard Deviation|Mean
1212809|NCT00788255|Primary|Tmax|thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)|6 months||||minutes||Standard Deviation|Mean
1212810|NCT00788255|Primary|MRTG|thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)|6 months||||mm/min||Standard Deviation|Mean
1212811|NCT00788255|Primary|MA|thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)|6 months||||mm||Standard Deviation|Mean
1212812|NCT00788255|Primary|Alpha Angle|thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)|6 months||||degrees||Standard Deviation|Mean
1212813|NCT00788255|Primary|k Time|thromboelastographic indices - clot formation time (normal range, 1-3 min)|6 months||||minutes||Standard Deviation|Mean
1212814|NCT00788255|Primary|r Time|thromboelastographic indices - reaction time (normal range, 5-10 min)|6 months||||minutes||Standard Deviation|Mean
1212815|NCT00788073|Post-Hoc|ABC-FXS Social Avoidance Subscore|After completion of the study, but during data analysis, the ABC-C assessment was independently re-validated in Fragile X Syndrome subjects. The subscales were re-factored into a Fragile-X Syndrome specific ABC-C (ABC-FX). The ABC-FX contains the same 58 questions as the original ABC-C but there are six subscales. One of the subscales is Social Avoidance, which consists of 4 items. Minimum score is 0, maximum is 12. A decreased score indicates fewer social avoidant behaviors. A post-hoc analysis was performed from the study data examining the social avoidance subscale of the ABC-FX.|4 week treatment period||||Points on a scale||Standard Error|Least Squares Mean
1212816|NCT00788073|Primary|Aberrant Behavior Checklist Irritability Subscore|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|After 4 weeks of treatment||||Points on a scale||Standard Error|Least Squares Mean
1212870|NCT00787566|Secondary|Number of Emetic Episodes||24 hours|||||||
1212817|NCT00788008|Primary|Change in Neurocognitive Performance (Z-score)|"Mean change on composite scores (z-score) for memory and executive function measures.~Memory measures: Hopkins Verbal Learning Test–Revised and the Brief Visuospatial Memory Test–Revised.~Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination.~The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (<1%) to fall outside the -3.0 to +3.0 range.~Higher scores (and thus positive change value) indicate an improvement of function."|3 months post operatively||||z score||Full Range|Mean
1212818|NCT00787943|Primary|Number of Inflammatory Lesions (Papules and Pustules)|Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.|4 Weeks|Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat.|||Lesions|||Number
1212819|NCT00787930|Secondary|fa ROFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.|||units on a scale||Standard Deviation|Mean
1212820|NCT00787930|Secondary|fa LOFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.|||units on a scale||Standard Deviation|Mean
1212821|NCT00787930|Secondary|Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS).|up to 12 months|Number of subjects who who had >2 on the DWM hyperintensity assessment from the Boyko classification system.|||participants|||Number
1212822|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15.|12 months|Subjects who completed at least 4-12 months of consistent follow up appointments after stabilization from an acute manic episode. Note that 3 subjects dropped out of continuation treatment.|||participants|||Number
1212823|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania|Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions.|3 weeks|All subjects in an acute manic state who were treated with specified protocol.|||participants|||Number
1212824|NCT00787917|Secondary|Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||percentage of participants||Standard Error|Least Squares Mean
1212825|NCT00787917|Secondary|Change From Baseline in Average Oral Corticosteroid Use.||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||mg/day||Standard Deviation|Mean
1212826|NCT00787917|Secondary|Time to Steroid Free State.||12 months|No statistical analysis was performed due to insufficient study enrollment|||days||Standard Deviation|Mean
1212827|NCT00787917|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment||3 months, 6 months|No statistical analysis was performed due to insufficient study enrollment|||Liters||Standard Error|Least Squares Mean
1212828|NCT00787917|Secondary|Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||percentage||Standard Error|Least Squares Mean
1212829|NCT00787917|Primary|Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen||6 months of blinded treatment|No statistical analysis was performed due to insufficient study enrollment|||percentage||Standard Error|Least Squares Mean
1212830|NCT00787904|Secondary|Bone Mineral Density|Please note that the bone density measurements were done AFTER THE PRIMARY endpoints because bone mineral density changes take longer to see differences|2 years|||||||
1212831|NCT00787904|Primary|Percent Change in Thymus Size Measured by CT Scan||2 years||||percent change||Standard Deviation|Mean
1212871|NCT00787566|Secondary|Time to Treatment Failure|Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first|24 hours|||||||
1212833|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
1212834|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
1212835|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
1212836|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
1212837|NCT00787891|Primary|The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|36 weeks|Intention to Treat (ITT) analysis set|||Percentage of patients||95% Confidence Interval|Number
1212838|NCT00787891|Primary|The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|12 weeks|Intention to Treat (ITT) analysis set|||Percentage of participants||95% Confidence Interval|Number
1212839|NCT00787852|Secondary|Complete and Partial Response by CT Scan or MRI||within 30 days of last treatment|||||||
1212840|NCT00787852|Primary|Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0|6 patients came off study for toxicity|within 28 days after the last radiation treatment||||participants|||Number
1212841|NCT00787839|Secondary|Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes|Cost was expressed as cost (dollars) to identify a single case, with cases defined as (i) diabetes or (ii) high-risk dysglycemia. Cost projections for screening were conducted from both Medicare and VA perspectives. All screening projections assumed follow-up testing with an OGTT if the screening test exceeded a 70% specificity cut-off.|3 years||||Dollars|||Number
1212842|NCT00787839|Primary|Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast)|"Area under ROC curve (AROC) for prediction of diabetes (based on OGTT) and high-risk dysglycemia (based on OGTT, IGT with 2 hour OGTT glucose 140-199 mg/dl, and/or IFG with fasting glucose 110-125 mg/dl).~ROC curves are plots of (1-sensitivity) vs. (1-specificity) for all possible screening cutoffs, so a higher AROC indicates higher predictive accuracy. A perfect test would have an AROC of 1.00, while a test equivalent to tossing a coin (random) would have an AROC of 0.50; if confidence limits include 0.50, predictive accuracy is no better than chance.~It is important to appreciate that while AROC analysis can show the relative accuracy of different screening tests, and aid the selection of which test to use in clinical practice, such an analysis does not define what the optimal screening test cutoff is. Selection of the optimal cutoff generally requires consideration of other factors, such as costs and/or the clinical importance of having higher or lower sensitivity."|3 years||||area under ROC curve||95% Confidence Interval|Number
1212843|NCT00787800|Secondary|Atrial Fibrillation (AF) Burden|AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.|Implantation through 1 year|Intent to treat analysis population.|||Percentage of atrial arrhythmias per min||Standard Deviation|Mean
1212844|NCT00787800|Secondary|Number of Subjects With Newly Detected Atrial Tachyarrhythmias||Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.|||Participants|||Number
1212845|NCT00787800|Secondary|Total Cost of ICD Implantation Procedure||Baseline|Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs.|||US Dollars||Standard Deviation|Mean
1212846|NCT00787800|Secondary|Number of Appropriate Shocks by ICD|Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.|Baseline to 12 Months|Intent to Treat population analyzed.|||Shocks|||Number
1212847|NCT00787800|Secondary|Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes|Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.|Baseline to 12 Months|Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm).|||Episodes|||Number
1212872|NCT00787566|Secondary|Time to First Rescue Medication||24 hours|||||||
1212873|NCT00787566|Secondary|Time to First Emetic Episode||24 hours|||||||
1212850|NCT00787787|Secondary|Best Response by RECIST Criteria|Incidence rate of best clinical response (complete response [CR], partial response [PR], stable disease [SD], or progressive disease[PD]) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR indicates disappearance of all target lesions. PR indicates at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease indicates at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) indicates neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years|Only 4 patients in this study had assessments of response by RECIST criteria.|||Participants|||Count of Participants
1212851|NCT00787787|Primary|Median Progression-free Survival|Analyzed using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease (PD) indicates at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment to time of progression or death from any cause, assessed up to 3 years||||days||Full Range|Median
1212852|NCT00787761|Secondary|Overall Survival (OS) at 24 Months|Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease.|24 months|23 patients were able to be analyzed for OS at 24 months|||participants|||Number
1212853|NCT00787761|Secondary|Disease-free Survival (DFS) at 24 Months|Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted.|24 months|23 patients were able to be analyzed for DFS at 24 months|||participants|||Number
1212854|NCT00787761|Secondary|Non-relapse Mortality (NRM) at Day 180 Post-transplantation|non-relapse mortality refers to the death of a patient for causes other than relapsed disease.|Day 180|23 patients were able to be analyzed for NRM at 180 days|||participants|||Number
1212855|NCT00787761|Secondary|Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)|Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|2 years|23 patients were able to be analyzed for severe gvhd|||participants|||Number
1212856|NCT00787761|Secondary|Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease|number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|Day 100|23 patients were able to be analyzed for severe gvhd|||participants|||Number
1212857|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|180 days|20 of the patients treated on study had chimerism drawn on day 180.|||participants|||Number
1212858|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|20 of the patients treated on this study had Day 90 chimerism drawn.|||participants|||Number
1212859|NCT00787761|Primary|Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|only 15 of the patients treated on study had Day 30 chimerism results.|||participants|||Number
1212860|NCT00787644|Primary|PC20|"Airway reactivity will be measured with methacholine challenge testing following ATS guidelines.~This is the concentration of methacholine that produces a 20% decrease in lung function (measured by forced expiratory volume in 1 second)"|12 weeks||||mg/ml||Standard Deviation|Median
1212861|NCT00787618|Primary|Cmax of Proellex||48 hours|Study prematurely terminated||||||
1212862|NCT00787605|Secondary|Evaluate the Safety and Tolerability|Percentage of patients with Adverse Event and percentage of patients with edema|after 8 weeks of treatment|safety|||Percentage of participants|||Number
1212863|NCT00787605|Secondary|Biomarker Measurements|Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)|Baseline and Week 8|Full analysis set, intent-to-treat|||ratio||95% Confidence Interval|Geometric Mean
1212864|NCT00787605|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure < 130/80 mmHg.|after 8 weeks of treatment|Full analysis set, intent-to-treat|||Percentage of Participants|||Number
1212865|NCT00787605|Secondary|Percentage of Responders|Response defined by mean sitting Systolic Blood Pressure < 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure >= 20 mm Hg from baseline|Week 8|Full analysis set, intent-to-treat|||Percentage of Participants|||Number
1212866|NCT00787605|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline and Week 8|Full analysis set, intent-to-treat|||mmHg||Standard Error|Least Squares Mean
1212867|NCT00787605|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set, intent-to-treat|||mmHg||Standard Error|Least Squares Mean
1212868|NCT00787566|Secondary|Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS|VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied|24 hours|||||||
1212869|NCT00787566|Secondary|Severity of Nausea Measured by a 4 Categorical Scale|4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden)|24 hours|||||||
1212880|NCT00787566|Primary|Percentage of Patients With Complete Control|Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.|24 hours|ITT population|||Percentage|||Number
1212881|NCT00787527|Primary|Phase II MTD of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days||||mg/three times daily|||Number
1212882|NCT00787527|Primary|Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat|MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.|21 Days||||participants|||Number
1212883|NCT00787527|Primary|Phase I Maximum Tolerated Dose (MTD) of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days||||mg/day|||Number
1212884|NCT00787332|Primary|New Thrombosis, Amputation, Death, Major and Minor Bleeding||30 days|All patients receiving drug|||participants|||Number
1212885|NCT00787319|Other Pre-specified|Physician's Assessment of Tolerability|Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||participants|||Number
1212886|NCT00787319|Other Pre-specified|Mean Number of Doses of Study Medication Received||Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||doses||Standard Deviation|Mean
1212887|NCT00787319|Other Pre-specified|Duration of Treatment|Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||weeks||Standard Deviation|Mean
1212888|NCT00787319|Other Pre-specified|Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||participants|||Number
1212889|NCT00787319|Other Pre-specified|Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring|Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|Safety analysis set included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||participants|||Number
1212890|NCT00787319|Secondary|Physician's Assessment of Efficacy|Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Week 104 or End of study (EOS)|FAS included all enrolled participants who received study medication.|||participants|||Number
1212891|NCT00787319|Secondary|Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.|Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||participants|||Number
1212905|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)|The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1225766|NCT00697593|Primary|Hematology - Eosinophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
1212892|NCT00787319|Secondary|Change From Baseline in Visual Acuity (VA) at Each Visit|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||logMAR||Standard Deviation|Mean
1212893|NCT00787319|Primary|Change From Baseline in Visual Acuity (VA) at Final Visit|Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Final Visit (Week 104 or early termination [ET])|Full analysis set (FAS) included all enrolled participants who received study medication. Missing values were imputed using last observation carried forward (LOCF) method.|||logMAR||Standard Deviation|Mean
1212894|NCT00787267|Secondary|Determine Relationship Between K-ras Gene Mutation and Response to Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.||||||
1212895|NCT00787267|Secondary|Describe Change in Serum Levels of C-terminal Cross-linked Collagen I Between Pre-treatment and 6 Weeks After Starting Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.||||||
1212896|NCT00787267|Secondary|Grade 3-5 Toxicity Associated With Dasatinib Treatment|Number of subjects with Grade 3-5 toxicity as assessed using NCI CTCAE criteria with the attribution of possibly, probably, or definitely related to protocol treatment.|Duration of dasatinib treatment plus 30 days|All subjects who received at least one dose of dasatinib were included in the analysis.|||participants|||Number
1212897|NCT00787267|Secondary|Overall Survival|Overall survival (OS) is the duration from date of consent to date of death from any cause.|Progression and survival every 6 months|All subjects who received at least one dose of dasatinib were included in the analysis.|||months||95% Confidence Interval|Median
1212898|NCT00787267|Primary|Tumor Response|"Tumor response rate was defined by RECIST criteria:~CR (complete response) = disappearance of all target lesions taking as reference the baseline sum of the longest diameter (LD); PR (partial response) = at least a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = at least a 20% increase in the sum of the longest diameter of target lesions as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD (stable disease) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started"|2 years|Unable to determine the response for 9 subjects.|||participants|||Number
1212899|NCT00787254|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|Per Incidence (up to 24 months).||||participants|||Number
1212900|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212901|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212902|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212903|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212904|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1214740|NCT00773474|Primary|Progression Free Survival|To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.|18 months|20 participants were eligible for analysis via the Kaplan-Meier method. PFS assessed via RECIST criteria.|||days||95% Confidence Interval|Mean
1212906|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212907|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212908|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212909|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212910|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212911|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212912|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212913|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212914|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212915|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212916|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212917|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212918|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212919|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1214741|NCT00773461|Secondary|Time to First Remission|Time to first Remission was calculated as the number of days from the date of first dose of study drug administration to the date of first achievement of DAS<2.6|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Days||95% Confidence Interval|Median
1212920|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212921|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212922|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212923|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212924|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212925|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212926|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212927|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212928|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212929|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212930|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212931|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212932|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1213021|NCT00786565|Primary|Mesoptic Contrast Sensitivity|The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 Months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1212933|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212934|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212935|NCT00787254|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|On occurrence (up to month 24).|On days where participants did not have an occurrence of gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) and who also underwent endoscopic examination were considered censored dates. Values are from the Full Analysis Set.|||participants|||Number
1212936|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212937|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212938|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212939|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212940|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212941|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212942|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212964|NCT00787150|Other Pre-specified|Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban|Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||Second||Standard Deviation|Mean
1212943|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212944|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212945|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1212946|NCT00787254|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|24 Months|Participants not taking investigational drug were not included.|||participants|||Number
1212947|NCT00787241|Secondary|Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia|Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.|1 week to time of neuraxial analgesia||||Hours||Full Range|Median
1212948|NCT00787241|Secondary|Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia|The positive predictive value of the platelet count closest to neuraxial analgesia with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the closest platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the closest available platelet count multiplied by 100.|0 to 72 hours following delivery||||percentage of positive platelet counts|||Number
1212949|NCT00787241|Primary|Positive Predictive Value of Earliest Available Platelet Count|The positive predictive value of the earliest available platelet count with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the first platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the earliest available platelet count multiplied by 100.|0 to 72 hours following delivery||||percentage of positive platelet counts|||Number
1212950|NCT00787202|Secondary|Plasma Concentration of CP-690,550|Summary statistics were calculated for each dose group using the nominal collection times and by setting concentration values below the lower limit of quantification (LLOQ) (LLOQ=0.1 nanogram per milliliter [ng/mL]) to zero.|0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8|Analysis population included all participants who had at least 1 plasma concentration. N=evaluable participants for this measure.|||ng/mL||Standard Deviation|Mean
1212951|NCT00787202|Secondary|Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||milligram per kilogram (mg/kg)||Standard Deviation|Mean
1212952|NCT00787202|Secondary|Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||milligram per liter (mg/L)||Standard Deviation|Mean
1212953|NCT00787202|Secondary|Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8|IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicates better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1212954|NCT00787202|Secondary|Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12|Partial Mayo score was ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Baseline-observation-carried-forward (BOCF) was used for participants who withdrew as TF. Missing data due to reasons other than treatment failure were excluded. N=evaluable participants for the measure.|||units on a scale||Standard Deviation|Mean
1212955|NCT00787202|Secondary|Percentage of Participants With Endoscopic Remission|Endoscopic remission was defined as the findings of flexible proctosigmoidoscopy subscore of the Mayo score equals 0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
1212956|NCT00787202|Secondary|Percentage of Participants With Endoscopic Response|Endoscopic response was defined as decrease from baseline in the findings of the flexible proctosigmoidoscopy subscore of the Mayo score at least 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
1212957|NCT00787202|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score:instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
1212958|NCT00787202|Primary|Percentage of Participants With Clinical Response|Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|Full analysis set (FAS): all participants who withdrew as treatment failure (TF) or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF=non-responders. Missing data due to reason other than TF were excluded. N (number of participants analyzed)=evaluable participants for the measure.|||percentage of participants|||Number
1212959|NCT00787189|Secondary|Tinnitus, Hearing-related Quality of Life||up to 6 months|||||||
1212960|NCT00787189|Primary|Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.|Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the CID W-22 lists. The percent of total words repeated correctly for each ear was recorded and the change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.|baseline and one week|ITT analysis.|||participants|||Number
1212961|NCT00787150|Other Pre-specified|Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
1212962|NCT00787150|Other Pre-specified|Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||pmol/L||Standard Deviation|Mean
1212963|NCT00787150|Other Pre-specified|Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
1213018|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||24 Months|Patients without missing values for best corrected HCVA logmar at pre-operative and post operative at 1 month control.|||LogMar||Standard Deviation|Mean
1212965|NCT00787150|Other Pre-specified|Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||International normalized ratio||Standard Deviation|Mean
1212966|NCT00787150|Other Pre-specified|Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||second||Standard Deviation|Mean
1212967|NCT00787150|Other Pre-specified|Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|0, 2, 4 hours postdose at Week 1 and Week 8|The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
1212968|NCT00787150|Secondary|Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
1212969|NCT00787150|Secondary|Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
1212970|NCT00787150|Secondary|Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
1212971|NCT00787150|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period|Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
1212972|NCT00787150|Secondary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period|Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
1212973|NCT00787150|Secondary|Number of Participants With Total Bleeding Events During the Treatment Period|Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
1212974|NCT00787150|Primary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
1213019|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||24 Months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.|||LogMar||Standard Deviation|Mean
1213022|NCT00786565|Secondary|High Contrast Visual Acuity||12 months|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
1212975|NCT00787137|Primary|The Number of Episodes of Change From Screening in Laboratory Assessments|Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.|Three months||||Number of episodes of change|||Number
1212976|NCT00787137|Primary|The Number of Episodes of Change in Electrocardiogram|Episodes of clinically significant change in 12-lead electrocardiogram predose,1 & 4 hours and 1 & 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.|Three months||||Number of episodes of change|||Number
1212977|NCT00787137|Primary|The Number of Episodes of Change in Vital Signs|Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 & 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.|Three months||||Number of episodes of change|||Number
1212978|NCT00787137|Primary|The Percentage of Participants With Adverse Events||Three months|All patients dosed were evaluated|||Percentage of Participants|||Number
1212979|NCT00787137|Primary|The Number of Reported Adverse Events|This was an exploratory study and all safety endpoints were considered.|Three months|All adverse events reported for all patients dosed were evaluated|||Number of adverse events|||Number
1212980|NCT00787124|Primary|SNOHgB Levels|levels were never run by the laboratory|beginning and end of study|||||||
1212981|NCT00787124|Secondary|Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.|data not appropriately collected for the analysis due to machine malfunctions.|prior to, during, after transfusion|||||||
1212982|NCT00787020|Secondary|Cerebrospinal Fluid (CSF) Output Per Day||14 Days||||Milliliter||95% Confidence Interval|Mean
1212983|NCT00787020|Secondary|External Ventricular Drain (EVD) Complications|External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.|14 Days||||Participants|||Number
1212984|NCT00787020|Primary|Cerebral Artery Vasospasm|Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.|14 days||||Participants|||Number
1212985|NCT00786994|Primary|Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.|"Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.~The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success."|18 weeks||||participants|||Number
1212986|NCT00786916|Primary|Maximal Pain/Discomfort|"FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where 0 represented no pain and 100 (the furthest point to the left) represented the worst pain ever."|during initial 3 minute propofol infusion|All enrolled subjects were randomized into groups A, B or C by hospital pharmacists utilizing a standard prerandomization methodology.|||units on a scale||Standard Deviation|Mean
1212987|NCT00786864|Secondary|Hamstring Flexibility|Standardised hamstring muscle length test. The child was positioned in supine, with the hip flexed at 90 degrees. The knee was then extended passively. The angle of knee extension [from horizontal plane (level to plinth) to fibula] was measured using a digital inclinometer. Continuous data. Scores ranged from -20 (worst score) to 82 (best score).|3 months post-intervention|Intention to treat analysis|||degrees||Standard Deviation|Mean
1212988|NCT00786864|Primary|Low Back Pain Intensity|The visual analogue scale (standardised 100mm, non-hatched line) was used to determine pain intensity. Scores can range between 0 and 10, with the worst possible pain/score = 10 and no pain/best score = 0. Visual analogue scale is continuous.|3 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
1212989|NCT00786864|Secondary|Neural Mobility|Straight leg raise test was used to measure neural mobility. The amount of hip flexion (angle between the plinth and femur of the raised leg) was measured using a digital inclinometer. Scores ranged between 3 (worst score) and 90.5 (best score). Continuous data.|3 months post-intervention|Intention to treat analysis|||degrees||Standard Deviation|Mean
1212990|NCT00786864|Primary|Low Back Pain Prevalence|All of the children complained of low back pain at baseline. Low back pain prevalence post-intervention was determined by the number of children still complaining of low back pain post-intervention.|3 months post-intervention|Intention to treat analysis|||participants|||Number
1212991|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett’s Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett’s Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||milli seconds||Standard Deviation|Mean
1212992|NCT00786838|Secondary|Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose||Baseline (predose on Day 1) to 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order was excluded from evaluations. 73 participants analyzed in trabectedin group to derive the mean.|||beats per minute||Standard Deviation|Mean
1212993|NCT00786838|Secondary|Number of Participants With QRS Interval Greater Than 120 Milli Seconds|QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1212994|NCT00786838|Secondary|Number of Participants With PR Interval Greater Than 200 Milli Seconds|PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1212995|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 500 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1212996|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 480 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1212997|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 450 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1212998|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1212999|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1213000|NCT00786838|Secondary|Time Taken to Acheive Maximum Plasma Concentration (Tmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||hours||Standard Deviation|Mean
1213001|NCT00786838|Secondary|Maximum Plasma Concentration of Trabectedin (Cmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||nanogram per milliliter||Standard Deviation|Mean
1213002|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||milli seconds||Standard Deviation|Mean
1213003|NCT00786799|Secondary|Change in Serum TNFα (Cytokine) Level||Baseline and 1 year||||pg/ml||Standard Deviation|Mean
1213004|NCT00786799|Secondary|Change in Percentage of Serum Omega-3 Fatty Acids|Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)|Baseline and 1 year||||Percent change of levels of fatty acid||Standard Deviation|Mean
1213020|NCT00786565|Primary|Posterior Capsule Opacification Score|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|24 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.|||EPCO Score||Standard Deviation|Mean
1213005|NCT00786799|Primary|Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups)|Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from “no problem” to “major problem”). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement.|Baseline and 1 year||||scores on a scale||Standard Deviation|Mean
1213006|NCT00786682|Secondary|Overall Survival||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.||||||
1213007|NCT00786682|Secondary|Time to Disease Progression||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.||||||
1213008|NCT00786682|Primary|Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.|We will use a two-stage optimal Simon’s design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The “expected” sample size of the trial is 23.5 with the null response rate of 50%.|4 years|Upon reviewing response data for the first 8 patients, we noted that there were no responses thus far. As per the two-stage optimal Simon's design, we would need 8 responses in 15 patients to proceed to stage 2 but we would not have crossed that threshold. The study was stopped due to lack of improved efficacy compared to historical controls.||||||
1213009|NCT00786643|Secondary|Time to Progression|Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months||||Months||95% Confidence Interval|Median
1213010|NCT00786643|Secondary|Early Response Rate (RR) (Stratum 1 Only)|Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.|After 4 cycles of treatment (approximately 56 days)|Prior to the 5th cycle of treatment, early response rate was evaluated in patients in stratum 1 to assess whether bevacizumab would be added to the GFL treatment regimen. Stratum 1 patients with SD at this time point will have bevacizumab added to the regimen. Subjects in stratum 2 were not evaluated for this outcome.|||Participants|||Number
1213011|NCT00786643|Primary|Best Response (BR)|BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.|After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)|The best response is the best response recorded from the start of treatment until disease progression. Imaging was repeated by same technique after every 4 cycles of treatment. Subjects in both strata were evaluated for this outcome.|||Participants|||Number
1213012|NCT00786565|Secondary|Posterior Capsule Opacification|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|12 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.|||EPCO Score||Standard Deviation|Mean
1213013|NCT00786565|Secondary|Contrast Sensitivity Mesoptic|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1213014|NCT00786565|Secondary|Contrast Sensitivity Mesoptic 1.5 Cpd|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1213015|NCT00786565|Secondary|Contrast Sensitivity Photopic|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1213016|NCT00786565|Secondary|Contrast Sensitivity Photopic 1.5cpd|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1213017|NCT00786565|Secondary|Low Contrast Visual Acuity|Uncorrected Low contrast visual acuity - LogMar visual acuity value|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||LogMar||Standard Deviation|Mean
1213025|NCT00786565|Secondary|High Contrast Visual Acuity|High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.|1 month|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
1213026|NCT00786565|Primary|Photopic Contrast Sensitivity|The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1213027|NCT00786565|Primary|Low Contrast Uncorrected Visual Acuity Following Cataract Surgery|Low contrast uncorrected visual acuity 3 months post cataract surgery|3 months|Full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy|||LogMAR||Standard Deviation|Mean
1213028|NCT00786565|Primary|Low Contrast Best Corrected Visual Acuity Following Cataract Surgery|Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.|3 months|Number of participants 67 total with 67 eyes in each group, full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy.|||LogMAR||Standard Deviation|Mean
1213029|NCT00786487|Primary|Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion|Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)|at 6 hours after starting lipid/glycerol infusion||||M value||Standard Deviation|Mean
1213030|NCT00786474|Secondary|Number of Participants With Minor Bleeding|Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data|||participants|||Number
1213031|NCT00786474|Secondary|Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism||from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||participants|||Number
1213032|NCT00786474|Primary|Major Bleeding|Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||participants|||Number
1213033|NCT00786474|Primary|Number of Arterial Thromboembolic Events|The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||Arterial thromboembolic events|||Number
1213034|NCT00786422|Secondary|Percentage of Participants With Other Vascular Events|All events were adjudicated and confirmed by a central independent adjudication committee. Other vascular events comprised ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), unstable angina (UA), ischemic stroke, transient ischemic attack (TIA), non-central nervous system systemic embolism and vascular death.|Up to 3 months treatment and during subsequent 1 day|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
1213035|NCT00786422|Secondary|Percentage of Participants With Treatment Emergent Deaths - 7 Days Window|Treatment emergent deaths were adjudicated by a central independent adjudication committee. Participants who died from treatment emergent adverse events were counted for this measure.|Up to 3 months treatment and during subsequent 7 days|All participants|||Percentage of participants|||Number
1213036|NCT00786422|Secondary|Percentage of Participants With All Deaths|All deaths were adjudicated by a central independent adjudication committee. Participants who died for any reason were counted for this measure.|Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month|All participants|||Percentage of participants|||Number
1213037|NCT00786422|Secondary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee. The composite efficacy outcome symptomatic recurrent VTE was analyzed descriptively, with the components: Death due to PE, death for which PE cannot be excluded, symptomatic PE and DVT, symptomatic recurrent PE only, and symptomatic recurrent DVT only up to the end of intended treatment period (3 months; 98 study days) and on-treatment (up to 2 days after stop of study drug).|Up to 3 months treatment and during subsequent 30-day observational period for an individual participant|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
1213038|NCT00786422|Primary|Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)|All events were adjudicated and confirmed by a central independent adjudication committee. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|Up to 3 months treatment and during subsequent 2 days|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
1213100|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration|Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||Ratio|||Number
1213039|NCT00786422|Primary|Pharmacokinetics – Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmin,ss was predicted for each individual participant from rivaroxaban plasma concentrations and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||µg/L||90% Confidence Interval|Median
1213040|NCT00786422|Primary|Pharmacokinetics – Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmax,ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||µg/L||90% Confidence Interval|Median
1213041|NCT00786422|Primary|Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban|AUC(0-24)ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||(µg*h)/L||90% Confidence Interval|Median
1213042|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Slope|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out of PT is in seconds. The PT slope describes the linear increase of PT for one unit increase in concentration, thus the unit of PT slope is s*(µg/L)^-1. The final population PK/PD model included a fixed slope that was fitted to the data of the 19 patients that were eligible for evaluation. The estimated mean value (fixed/ the same for all patients in this study) is presented for PT slope.|Up to 3 months treatment|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||s*(µg/L)^-1|||Number
1213043|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Baseline Value|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Mean and standard deviation (SD) values are presented for PT baseline.|The baseline value of prothrombin time is measured or calculated at a rivaroxaban concentration of 0 µg/L and is based on the observations that were made during the 3 months treatment period|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||Seconds||Standard Deviation|Mean
1213044|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)||7 months|17 patients were Lupus anticoagulant negative at entry.|||Participants|||Count of Participants
1213045|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)||7 months|13 patients were Smith negative at entry.|||Participants|||Count of Participants
1213046|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP||7 months|8 patients were negative for anti-RNP at entry|||Participants|||Count of Participants
1213047|NCT00786409|Primary|SLEDAI Change Score|Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.|7 months||||units on a scale||95% Confidence Interval|Mean
1213048|NCT00786409|Primary|Anti-HPV 18 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
1213049|NCT00786409|Primary|Anti-HPV 18 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
1213050|NCT00786409|Primary|Anti-HPV 16 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
1213051|NCT00786409|Primary|Anti-HPV 16 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
1213052|NCT00786409|Primary|Anti-HPV 11 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
1213053|NCT00786409|Primary|Anti-HPV 11 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
1213054|NCT00786409|Primary|Anti-HPV 6 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
1213055|NCT00786409|Primary|Anti-HPV 6 Seroconversion|Percent Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
1213056|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8|Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.|Week 4 and Week 8||||BMI Kg/m2||Standard Error|Mean
1213057|NCT00786188|Secondary|Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8|"The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.~The measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question."|Week 4 and Week 8||||Percentage of true responders|||Number
1213058|NCT00786188|Secondary|Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated.|Week 8||||units on a scale||Standard Error|Mean
1213059|NCT00786188|Secondary|Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8|The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 4 and Week 8||||Percentage of participants|||Number
1213060|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4|"Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question."|Week 4||||percentage of responders|||Number
1213061|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4|"Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 335.~The percentage of participants who had a change from baseline in the total score at Week 4 is reported below."|Week 4||||percentage of participants|||Number
1213062|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8|"Depression & anxiety were measured using the Hospital Anxiety & Depression Scale (HADS).~The HADS is a scale developed to assess anxiety & depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.~The results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression combined at Week 8."|Week 8||||participants|||Number
1213063|NCT00786188|Secondary|Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8|"A scale was not used for this measurement.~Composite scores of hot flashes were calculated by using the following formula:~CS = (2 • Fm + 3 • Fs)~Where:~CS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score."|Week 4 and Week 8||||Composite score||Standard Error|Mean
1213064|NCT00786188|Secondary|Change From Baseline in Climacteric Symptoms at Week 8|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 8||||units on a scale||Standard Error|Mean
1213065|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8|"A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.~SS = (2•Fm + 3•Fs) ÷ (Fm + Fs)~Where:~SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score."|Week 4 and Week 8||||Severity score||Standard Error|Mean
1213066|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8|"The number of hot flashes reported in the result table are:~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week."|Week 4 and Week 8|MODIFIED ITT (MITT) POPULATION Brisdelle 49 (98.0%) Placebo 52 (100.0%) PER PROTOCOL (PP) POPULATION Brisdelle 45 (90.0%) Placebo 51(98.1%)|||Hot flashes||Standard Error|Mean
1213080|NCT00785928|Secondary|Change From Baseline in Serum Immunoglobulin up to 24 Weeks|Serum immunoglobulin measured by Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) levels.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||gram per liter (g/L)||Standard Deviation|Mean
1213067|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by selection rate. Accuracy rate – The proportion of correct selections made during the daily calibration period of “copy spelling.” Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g, THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The number of selections/min for the BCI applications was averaged across users.|Up to 18 months||||number of selection per minute||Standard Deviation|Mean
1213068|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by accuracy. Accuracy rate – The proportion of correct selections made during the daily calibration period of “copy spelling.” Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g., THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The independent-use periods of the 14 independent users was totaled by days. Of these days, BCI use was not possible for days (i.e. hiatus days) due to hospitalization, illness, home construction, travel, or BCI system assistant (SA) absence. Over these days, copy-spelling accuracy was averaged.|Up to 18 months||||percentage of days||Standard Deviation|Mean
1213069|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by time per application.|Up to 18 months||||percentage of BCI time||Standard Deviation|Median
1213070|NCT00786032|Secondary|Facility Support Speed of Solution|This study will look at how the technical problems of the BCI are supported by the facility through analyzing the speed of solution.|Up to 18 months||||hours||Standard Deviation|Mean
1213071|NCT00786032|Secondary|Time of BCI Impact on the Significant Other and Systems Operator|The quality of life of the significant other, caregiver and system operator will be measured using the Caregiver Burden Assessment at visits. At three month intervals, the significant other, caregiver and system operator will be asked to estimate how much time they spend on the following tasks per day in minutes: BCI System setup ( placing the electrode cap and initiating system operation), BCI System cleanup, and BCI System maintenance (removing cap).|Up to 18 months||||minutes||Standard Deviation|Mean
1213072|NCT00786032|Secondary|BCI Usage by and Impact on the ALS Patient|At three-month intervals, BCI use will be summarized. On a daily basis the BCI will record the total of number of selections made in copy spelling mode. Copy spelling mode is used for system calibration. Participants are expected to indicate that the burden associated with BCI use is inconsequential to the benefit derived from using the BCI. This will be assessed by the McGill Quality of Life (MQOL) at each visit.|Up to 18 months||||units on a scale||Standard Deviation|Mean
1213073|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by total time.|Up to 18 months||||days||Standard Deviation|Mean
1213074|NCT00786019|Primary|Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training|Evaluate potential changes in cardiac function by echocardiography following 2 interventions: Three months of exercise training and acute vitamin C administration. Ejection fraction (EF) is a measurement of the percentage of blood leaving your heart each time it contracts, typically measure by echocardiography. Numbers listed are absolute EF values.|7 months; Measures are made at rest for baseline, at rest for Vitamin C administration, and at rest following the exercise training||||percentage of blood leaving the heart||Standard Deviation|Mean
1213075|NCT00786019|Primary|Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training|Characterize the purported cardiac dysfunction during exercise in people with type 2 diabetes (T2D). In a normal patient when measuring circumferential strain, results are negative with downward tracing (as strain is a relative change in length). Circumferential strain is a measurement of ventricular circumference within the heart vessels, measured via echocardiography.|7 months; Measures are made at rest and after exercise for baseline, at rest and after infusion for Vitamin C administration, and at rest and after exercise following the exercise training||||percentage of change in length||Standard Deviation|Mean
1213076|NCT00785980|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on 20 subjects out of the 21 subjects who completed the study. One value was determined to be unreliable and was not used.|||ng-hr/mL||Standard Deviation|Mean
1213077|NCT00785980|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.||||ng-hr/mL||Standard Deviation|Mean
1213078|NCT00785980|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on twenty-one (21) subjects who successfully completed the study. Three (#3) subjects were dropped by the sponsor due to protocol violation.|||ng/mL||Standard Deviation|Mean
1213079|NCT00785928|Secondary|Number of Participants Experiencing An Adverse Event|Serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.|Baseline up to 24 weeks|All randomized participants who received any amount of blinded study drug.|||Participants|||Count of Participants
1213081|NCT00785928|Secondary|Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks|B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. Total B cell counts (CD20+CD3-) are represented by the number of cells per microliter (cells/µL). The reference range is 43 – 602 cells/µL.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||cells per microliter (cells/µL)||Standard Deviation|Mean
1213082|NCT00785928|Secondary|Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks|T1/2,tau is defined as the apparent steady state elimination within the dosing interval. T1/2,tau was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.|24 weeks|The PK analysis population included all intent-to-treat (ITT) participants who received LY2127399 and who had evaluable PK data except 2 participants who were excluded due to Good Clinical Practice (GCP) issues.|||days|||Number
1213083|NCT00785928|Secondary|Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks|C-trough is defined as the concentration of LY2127399 at the end of the dosing interval after the subcutaneous (sc) injection dosing once every 4 weeks. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.|24 weeks|The PK analysis population included all intent-to-treat (ITT) participants who received LY2127399 and who had evaluable PK data except 2 participants who were excluded due to Good Clinical Practice (GCP) issues.|||micrograms per milliliter (µg/mL)|||Number
1213084|NCT00785928|Secondary|Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks|A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains. MCS and PCS scores = 0 to 100 (higher scores indicate better health status).|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
1213085|NCT00785928|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks|The FACIT Fatigue Scale is a brief participant-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
1213086|NCT00785928|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks|Percent change = [(postbaseline CRP - baseline CRP)/baseline CRP]*100.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percent change||Standard Deviation|Mean
1213087|NCT00785928|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks|Participant's assessment of physical function. Disability section of questionnaire scores participant’s self-perception on degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do) when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities. Scores for each of the functional areas were averaged to calculate the functional disability index. The HAQ-DI total score, which is the average of the nonmissing functional scores, ranges from 0 (no disability) to 3 (severe disability).|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
1213088|NCT00785928|Secondary|Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks|Physician's assessment of disease activity using a visual analog scale (VAS) that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
1213089|NCT00785928|Secondary|Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks|Participant's assessment of disease activity using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
1213090|NCT00785928|Secondary|Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks|Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no pain and 100 indicated worst possible pain.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
1213091|NCT00785928|Secondary|Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks|The EULAR28 categorizes clinical response based upon improvement since baseline in the Disease Activity Score (DAS) modified to include the 28 joint count (DAS28) and post-baseline DAS28 level. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (participant global visual analog scale [VAS]). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units).|Up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
1213092|NCT00785928|Secondary|Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks|DAS (modified to include the 28 joint count [DAS28]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of his or her disease activity (participant global visual analog scale [pt global VAS]). The DAS28 is calculated by using the following formula: DAS28-CRP = 0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014*pt global VAS + 0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
1213093|NCT00785928|Secondary|Change From Baseline in Swollen Joint Count up to 24 Weeks|The number of swollen joints was determined by examination of 28 joints which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||swollen joints||Standard Deviation|Mean
1213094|NCT00785928|Secondary|Change From Baseline in the Tender Joint Count up to 24 Weeks|Number of tender and painful joints was determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. Participant was asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||tender joints||Standard Deviation|Mean
1213095|NCT00785928|Secondary|Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks|ACR20 Responder Index is composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|Up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF)/non-responder imputation (NRI). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
1213096|NCT00785928|Primary|Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with >50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|Up to week 24|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). Two participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
1213097|NCT00785798|Primary|Number of Subjects With Stable Disease (SD)||2 years||||participants|||Number
1213098|NCT00785798|Primary|Number of Subjects With Progressive Disease (PR)||2 years||||participants|||Number
1213099|NCT00785785|Primary|Time to Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to month 37|Full Analysis Set (FAS) consists of all randomized patients for the Core Phase.|||months||Full Range|Median
1213150|NCT00785291|Secondary|12 Month Progression Free Survival|Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|12 months|Participants who never began protocol treatment were excluded.|||percentage of participants||95% Confidence Interval|Number
1213101|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model|Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||Ratio|||Number
1213102|NCT00785772|Primary|Observed Plasma Gabapentin Concentration|Plasma gabapentin concentrations were measured on Day 8 and Day 15|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||µg/mL||Full Range|Mean
1213103|NCT00785707|Secondary|Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting|The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months.|24 months||||units on a scale||Full Range|Mean
1213104|NCT00785707|Primary|To Validate the LittleEARS Auditory Questionnaire|The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.|24 months||||units on a scale||Full Range|Mean
1213105|NCT00785629|Primary|Serum Phosphorus|mean serum phosphorus from months 3-9|months 3-9|ITT analysis was ALL active patients combined versus all placebo patients combined|||mg/dL||Standard Deviation|Mean
1213106|NCT00785577|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
1213107|NCT00785577|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||time (days)|||Number
1213108|NCT00785577|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.|||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
1213109|NCT00785577|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.|||participants|||Number
1213110|NCT00785577|Secondary|Number of Participants With Suicidal Behaviors and Ideations|"The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a yes answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation."|Baseline through week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||participants|||Number
1213111|NCT00785577|Secondary|Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score|The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213112|NCT00785577|Secondary|Percentage of Participants With Reported Hypoglycemic Events|"Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the Investigations system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||percentage of participants|||Number
1213113|NCT00785577|Secondary|Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB change ≥ 30 msec was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||participants|||Number
1219732|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 18||Baseline and week 18|Treated Set with values for HbA1c at baseline and week 18. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1213114|NCT00785577|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1213115|NCT00785577|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1213116|NCT00785577|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
1213117|NCT00785577|Secondary|Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
1213118|NCT00785577|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213119|NCT00785577|Secondary|Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213120|NCT00785577|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants’ quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213121|NCT00785577|Secondary|Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks|NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5‑point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3‑point bothersome/importance scale (1=none to 3=very).|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213122|NCT00785577|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213151|NCT00785291|Secondary|Time to Treatment Failure|Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)|Participants who never began protocol treatment were excluded.|||months||95% Confidence Interval|Median
1213123|NCT00785577|Secondary|Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks|SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213124|NCT00785577|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.|||units on a scale||Standard Error|Least Squares Mean
1213125|NCT00785577|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213126|NCT00785577|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213127|NCT00785577|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213128|NCT00785577|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.|||participants|||Number
1213129|NCT00785577|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213130|NCT00785577|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1213131|NCT00785577|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.|||units on a scale||Standard Error|Least Squares Mean
1213132|NCT00785538|Secondary|Number of Participants With Best Overall Response|SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR and PD were assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Enrollment to study completion up to 215 weeks|All enrolled participants.|||Participants|||Count of Participants
1213133|NCT00785538|Secondary|Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)|Analysis was not performed due to lack of available assay.|Before the last infusion of each treatment cycle|Zero participants were analyzed due to lack of available assay.||||||
1213134|NCT00785538|Secondary|Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.|Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 (last dose of Cycle 1 only) and 336 hours (last dose of Cycle 1 only) postdose|All participants who received study drug and had PK data available to calculate Vss. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
1213135|NCT00785538|Secondary|Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses|CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.|Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 (last dose of Cycle 1 only) and 336 hours (last dose of Cycle 1 only) postdose|All participants who received study drug and had PK data available to calculate CLss.|||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1213136|NCT00785538|Secondary|Half-Life (t1/2) of IMC-A12 Following Multiple Doses|Half-Life (t1/2) is the time measured for the plasma concentration of the drug to decrease by one half. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.|Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 (last dose of Cycle 1 only) and 336 hours (last dose of Cycle 1 only) postdose|All participants who received study drug and had PK data available to calculate t1/2. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.|||days||Geometric Coefficient of Variation|Geometric Mean
1213137|NCT00785538|Secondary|Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses||Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 (last dose of Cycle 1 only) and 336 hours (last dose of Cycle 1 only) postdose|All participants who received study drug and had PK data available to calculate AUCτ.|||micrograms*hour/milliliter (µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1213138|NCT00785538|Secondary|Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses||Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 (last dose of Cycle 1 only) and 336 hours (last dose of Cycle 1 only) postdose|All participants who received study drug and had PK data available to calculate Cmin.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1213139|NCT00785538|Secondary|Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses||Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 (last dose of Cycle 1 only) and 336 hours (last dose of Cycle 1 only) postdose|All participants who received study drug and had PK data available to calculate Cmax.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1213140|NCT00785538|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT). A DLT was defined as any Grade 3 or 4 hematologic or nonhematologic toxicity based on Common Terminology Criteria for AE (CTCAE), excluding alopecia, which was considered by the investigator to be definitely, probably, or possibly related to IMC-A12.|6 weeks|All participants who received at least 1 dose of study drug and completed Cycle 1 and 2-week observation or discontinued treatment for an IMC-A12-related toxicity.|||mg/kg|||Number
1213141|NCT00785538|Primary|Number of Participants With Adverse Events (AEs) or Deaths|Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Enrollment to study completion up to 215 weeks|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1213142|NCT00785512|Secondary|Trough Sitting Systolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)||||mm HG||Standard Deviation|Mean
1213143|NCT00785512|Primary|Trough Sitting Diastolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)||||mm HG||Standard Deviation|Mean
1213144|NCT00785486|Primary|The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam|Qualaquin (quinine) - AUC tau alone at steady state (day 9) and in the presence of coadministered midazolam 2 mg (day 10) over the dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.|Days 9 and 10 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours|per protocol|||ng•h/mL||Standard Deviation|Mean
1213145|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to Infinity (AUC Inf) for Midazolam and 1 Hydroxy Midazolam Before (Day 1) and After (Day 10) Qualaquin (Quinine).|AUC inf for Midazolam and hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with steady state Qualaquin(quinine)- the sum of AUC0-t plus the ratio of the last measured plasma concentration to the elimination rate constant to determine whether a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|per protocol|||ng·h/mL||Standard Deviation|Mean
1213146|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to T (AUC 0-t) for Midazolam and 1-hydroxy Midazolam at Baseline and With Qualaquin (Quinine) at Steady State.|Area under the concentration time curve(AUC 0-t) calculated by the linear trapezoidal method from time 0 to 24 hours, for Midazolam and 1-hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with Qualaquin -(quinine) at steady state to determine if a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|by protocol|||ng•h/mL||Standard Deviation|Mean
1213147|NCT00785486|Primary|Maximum Serum Concentration (Cmax)|Maximum serum concentration(Cmax)|Day 1 (Midazolam Alone), Day 9 (Qualaquin (quinine) Alone), Day 10 Midazolam with Qualaquin (quinine)|per protocol|||ng/ml||Standard Deviation|Mean
1213148|NCT00785356|Primary|The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.||3 months|||||||
1213149|NCT00785291|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization to death or last follow-up (up to 5 years)||||months||95% Confidence Interval|Median
1213152|NCT00785291|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).|Up to 5 years||||percentage of participants|||Number
1213153|NCT00785291|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)|Participants who never began protocol treatment were excluded.|||months||95% Confidence Interval|Median
1213154|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug-hr/mL||Standard Deviation|Mean
1213155|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug-hr/mL||Standard Deviation|Mean
1213156|NCT00785213|Primary|Maximum Plasma Concentration (Cmax) of Rosiglitazone|The maximum or peak concentration that rosiglitazone reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug/mL||Standard Deviation|Mean
1213157|NCT00785044|Primary|Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status|The numerical value of 123 I-mIBG uptake (H/M ratio) at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.|From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months|Efficacy population was 961 participants who received IMP and had a consensus H/M ratio on 3 hour 50 minute planar image in MBG 311 or MBG 312. Here, number of participant analyzed = number of participants with available data for this endpoint.|||Ratio||Standard Deviation|Mean
1213158|NCT00784979|Secondary|Monitor Patient Survival||5 years|||||||
1213159|NCT00784979|Secondary|Monitor Graft Survival||5 years|||||||
1213160|NCT00784979|Primary|The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor|The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.|four weeks||||percent of subjects becoming compatible|||Number
1213161|NCT00784927|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.||||months||95% Confidence Interval|Median
1213162|NCT00784927|Secondary|Progression-free Survival Time|"Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death.~Progressive disease is defined as having one of the following:~The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.~At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Up to 1 year from registration.||||months||95% Confidence Interval|Median
1213163|NCT00784927|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.||||months||95% Confidence Interval|Median
1213175|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline, 2 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.|||minutes||Standard Error|Least Squares Mean
1213164|NCT00784927|Secondary|Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom’s Macroglobulinemia).|"The proportion of responses in Waldenstrom's macroglobulinemia was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.||||percentage of participants||95% Confidence Interval|Number
1213165|NCT00784927|Primary|Assessment of Tumor Response|"The proportion of responses was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.||||percentage of participants||95% Confidence Interval|Number
1213166|NCT00784875|Secondary|Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||milliseconds||Standard Error|Least Squares Mean
1213167|NCT00784875|Secondary|Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||beats per minute||Standard Error|Least Squares Mean
1213168|NCT00784875|Secondary|Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint|Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).|2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had endpoint value. For LY2624803 1 mg, LY2624803 3 mg, Zolpidem 5 or 10 mg, and Placebo, the Number of Participants Analyzed were as follows: Period B: N=114, 113,117, 117; Period C: N=103, 97, 97, 98; and Period D: N=91, 89, 94, 88.|||participants|||Number
1213169|NCT00784875|Secondary|Change From Baseline in Weight at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||kilogram||Standard Error|Least Squares Mean
1213170|NCT00784875|Secondary|Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||beats per minute||Standard Error|Least Squares Mean
1213171|NCT00784875|Secondary|Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||mmHg||Standard Error|Least Squares Mean
1213172|NCT00784875|Secondary|Number of Participants With Serious Adverse Events (SAEs)|SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.|||participants|||Number
1213173|NCT00784875|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.|||participants|||Number
1213174|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group|Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline through 8 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.|||participants||Standard Error|Least Squares Mean
1213176|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type|Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline through 8 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.|||participants|||Number
1213177|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline, 2 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.|||minutes||Standard Error|Least Squares Mean
1213178|NCT00784875|Secondary|Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
1213179|NCT00784875|Secondary|Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
1213180|NCT00784875|Secondary|Treatment Satisfaction as Measured by the Participant Drug Preference Question|After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.|Baseline (Period A) and 2 weeks (Period B)|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
1213181|NCT00784875|Secondary|Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint|The EuroQoL Questionnaire–5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1213182|NCT00784875|Secondary|Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1213183|NCT00784875|Secondary|Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint|The ISI is a brief self-report instrument that measures a participant’s perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1213184|NCT00784875|Secondary|Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint|DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1213185|NCT00784875|Secondary|Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint|Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1213251|NCT00784563|Secondary|Change in 7 Meter Walk Time|Time complete the 7 m Walk test after 6 months aerobic training - Time complete the 7 m Walk test at baseline|6 months|See PMID: 24991037|||seconds||Standard Deviation|Mean
1213186|NCT00784875|Secondary|Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint|Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||ratio||Standard Error|Least Squares Mean
1213187|NCT00784875|Secondary|Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint|Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
1213188|NCT00784875|Secondary|Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint|Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||number of awakenings||Standard Error|Least Squares Mean
1213189|NCT00784875|Secondary|Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint|Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
1213190|NCT00784875|Primary|Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
1213191|NCT00784849|Secondary|Superficial Skin Necrosis|the number of participants who developed post-operative skin necrosis within 2 weeks of surgery|2 weeks postoperatively||||participants|||Number
1213192|NCT00784849|Secondary|Safety (Allergic Reaction to Blue Dye)|number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension|intraoperatively up to 6 hours||||participants|||Number
1213193|NCT00784849|Primary|The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)||intraoperatively; up to 6 hours||||participants|||Number
1213194|NCT00784836|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Planned for up to 18 months plus 30 days; actual study duration was 111 days.||||participants|||Number
1213195|NCT00784836|Primary|Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)|The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.|assessed every 3 months up to 18 months|The study was terminated early before any of the 3 enrolled subjects completed the study; therefore, no statistical analysis was performed.||||||
1213196|NCT00784810|Secondary|Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.|"To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the number of intakes of rescue medication for this period (ie between Visit 8 and Visit 9)."|Between visit 8 and 9|The number of participants for analysis is less due to subject withdrawals or lack of data.|||Number of rescue medication intakes||Standard Deviation|Mean
1213252|NCT00784563|Primary|Change in Aerobic Fitness|"VO2max after the training - VO2max at baseline (Adjusted for levodopa-equivalent, year, training mode, setting).~Please see publication PMID: 24991037 for details."|6 months|Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for all analyses.|||ml/min/kg||Standard Deviation|Mean
1213197|NCT00784810|Primary|Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)|The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)|Average daily pain over last 24 hours (at Week 12)|To achieve a study with 80% power at the 1-sided 5% sig level and define non-inferiority to be a relative different less than 1.2. A sample size of 98 subjects per treatment group was required, ie a total of 196 subjects completing the study. The lower number of participants is due to subject withdrawal or lack of data.|||Units on a BS-11 scale at Week 12||Standard Deviation|Mean
1213198|NCT00784784|Primary|Number of Laboratory Confirmed Influenza Infections|Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)|6 months|intention to treat|||infections|||Number
1213199|NCT00784784|Secondary|Number of Subjects Adhering to Long-term Zanamivir Prophylaxis|Number of subjects taking 80% or more doses per week of zanamivir (10 mg once daily), as influenza prophylaxis, for 13 weeks or longer (as measured by weekly diary and dose counts at study visits).|5 months|ITT|||participants||95% Confidence Interval|Number
1213200|NCT00784719|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8|NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
1213201|NCT00784719|Secondary|Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8|mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.||||||
1213202|NCT00784719|Secondary|Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).|Baseline, Week 1, 2, 4, 6, 8|Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.||||||
1213203|NCT00784719|Secondary|Percentage of Participants With >= 10 Units Decrease in Total OSDI Score|OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1213204|NCT00784719|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here ‘N’ (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1213205|NCT00784719|Secondary|Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8|Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||drops/day||Standard Deviation|Mean
1213206|NCT00784719|Secondary|Percentage of Participants With >= 5 Units Decrease in Total OCI Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1213298|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <200 Copies/mL at Week 24|This measure was assessed in the same manner as the primary efficacy analysis for the proportion of patients achieving HIV-1 RNA levels below 200 copies/mL at Week 24 of the study.|Week 24||||percentage of patients|||Number
1219733|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 6||Baseline and week 6|Treated Set with values for HbA1c at baseline and week 6. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1213207|NCT00784719|Secondary|Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1213208|NCT00784719|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8|TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||seconds||Standard Deviation|Mean
1213209|NCT00784719|Secondary|Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8|Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1213210|NCT00784719|Secondary|Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining|Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1213211|NCT00784719|Secondary|Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8|Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1213212|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1213213|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6|ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1213214|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||mm||Standard Deviation|Mean
1213215|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||mm||Standard Deviation|Mean
1213216|NCT00784719|Secondary|Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1213217|NCT00784719|Secondary|Time to Achieve 100 Percent (%) Clearance of Corneal Staining|Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1213218|NCT00784719|Secondary|Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1213219|NCT00784719|Primary|Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.|||percentage of participants|||Number
1213220|NCT00784719|Primary|Percentage of Participants With Ocular Tolerability Assessment|Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).|Baseline up to Week 8|ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1213221|NCT00784719|Primary|Percentage of Participants With Ocular Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.|Baseline up to Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1213222|NCT00784719|Primary|Percentage of Participants With Systemic Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.|Baseline up to Week 8|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1213223|NCT00784654|Other Pre-specified|C-SSRS During the Randomized Withdrawal Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Baseline of the randomized withdrawal period to end of the study (Up to 6 weeks)|Randomized Safety Population|||participants|||Number
1213224|NCT00784654|Other Pre-specified|Columbia-Suicide Severity Rating Scale (C-SSRS) During The Open-label Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|From open-label baseline to Week-26|Open-label Safety Population|||participants|||Number
1213225|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Randomized Withdrawal Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Randomized withdrawal baseline|Randomized FAS|||percentage of participants|||Number
1213226|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Safety Population includes all subjects who received at least 1 dose of any investigational product during the Randomized Withdrawal Period|||Scores on a scale||Standard Deviation|Mean
1213227|NCT00784654|Secondary|Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label Safety Population includes all subjects who received at least 1 dose of investigational product in the Open-label period.|||Scores on a scale||Standard Deviation|Mean
1213228|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Error|Least Squares Mean
1213229|NCT00784654|Secondary|Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||scores on a scale||Standard Deviation|Mean
1213230|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||T-scores||Standard Error|Least Squares Mean
1213231|NCT00784654|Secondary|Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||T-scores||Standard Deviation|Mean
1213232|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Deviation|Mean
1213233|NCT00784654|Secondary|Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||scores on a scale||Standard Deviation|Mean
1213234|NCT00784654|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period|"Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.~Improvement includes CGI-I categories of very much improved and much improved. No improvement includes all other assessed categories."|At Week 26|Open-label FAS|||percentage of improved participants|||Number
1213235|NCT00784654|Secondary|Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At endpoint of the randomized withdrawal period (Up to 6 weeks)|Randomized FAS|||percentage of participants|||Number
1213236|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Open-label baseline|Open-label FAS|||percentage of participants|||Number
1213237|NCT00784654|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At Week 26|Open-label FAS|||percentage of participants|||Number
1213238|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Error|Least Squares Mean
1215763|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24||||MPS DA/month||Standard Deviation|Mean
1213239|NCT00784654|Secondary|Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Open-label baseline and Endpoint (Week-26)|Open-label Full Analysis set (Open-label FAS) includes all subjects who received at least 1 dose of investigational product during the Open-label Period.|||Scores on a scale||Standard Deviation|Mean
1213240|NCT00784654|Primary|Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period|"Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period.~Subjects without an endpoint value were classed as treatment failures."|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Full Analysis Set (Randomized FAS) includes all subjects who were randomized and received at least 1 dose of investigational product during the Randomized Withdrawal Period.|||percentage of participants|||Number
1213241|NCT00784563|Other Pre-specified|Change in LEDD (Levodopa Equivalent Daily Dose)|=amount after 6 months training - amount at baseline Total antiparkinsonian treatment daily dose expressed in levodopa equivalents per Tomlinson et al (PMID:21069833). Higher scores are worse.|6 months||||mg/day||Standard Deviation|Mean
1213242|NCT00784563|Secondary|Change in Percent Increase Score (PIS) on Eriksen's Flanker Task|performance on the Eriksen's flanker task (see PMID: 24991037). Participants were asked to identify the orientation of a central arrow cue (‘<’ or ‘>’), which was flanked on both sides by two arrow cues that either pointed in the same direction (congruent: <<<<<) or a different direction (incongruent: >><>>). Using reaction times (RT) during congruent and incongruent trials, the PIS was calculated as =((RT_incongruent – RT_congruent) / RT_congruent) * 100. Higher PIS is worse.|6 months||||Percentage of Increase score||Standard Deviation|Mean
1213243|NCT00784563|Secondary|Change in the MOCA Score|=Score after 6 months training - baseline score. MOCA=Montreal Cognitive Training Assessment Scores range 0-30, higher is better.|6 months||||units on a scale||Standard Deviation|Mean
1213244|NCT00784563|Secondary|Change in the Total UPDRS Score|"=Score after 6 months training - baseline score The total UPDRS score is calculated by adding Section I, Section II, and Section III scores (below). Higher scores are worse. The score ranges 0-176.~Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108."|6 months||||units on a scale||Standard Deviation|Mean
1213245|NCT00784563|Secondary|Change in the UPDRS Section III Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
1213246|NCT00784563|Other Pre-specified|Change in Parkinson’s Disease Quality of Life Scale (PDQUALIF) Score|= PDQUALIF score after 6 months training - baseline score The PDQUALIF is a 32 item questionnaire resulting in 7 factors. . Subjects rate themselves between 1 (most favorable) and 5 (least favorable) on a Likert scale. Factor scores are standardized to100 and lower scores are better. The outcome measure is the average of these 7 factor scores.|6 months||||units on a scale||Standard Deviation|Mean
1213247|NCT00784563|Other Pre-specified|Change in Geriatric Depression Scale Score|=Score after 6 months training - score at baseline. The Geriatric Depression Scale (GDS)-short form is a 15 item yes/no questionnaire. The range is 0-15 and scores >5 suggest depression. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
1213248|NCT00784563|Other Pre-specified|Change in Fatigue Severity Scale Score|=Score after 6 months of training - baseline score. The Fatigue Severity Scale (FSS) is a self-administered unidimensional generic 9-item fatigue rating scale. These are rated on a seven-grade Likert scale of which only the respective ends are defined (‘‘completely disagree’’=1 to ‘‘completely agree’’=7). The total FSS score represents the mean score of each of the nine items, yielding a score range between 1 and 7, higher scores indicating a higher level of fatigue.|6 months||||units on a scale||Standard Deviation|Mean
1213249|NCT00784563|Secondary|Change in UPDRS Section II Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
1213250|NCT00784563|Secondary|Change in the UPDRS Section I Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
1213253|NCT00784550|Secondary|Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint|The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.|Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)|ITT Population|||points on a scale||Standard Error|Mean
1213254|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)|ITT Population|||ml||Standard Error|Mean
1213255|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).|Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)|ITT Population|||ml||Standard Error|Mean
1213256|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.|Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)|ITT Population|||ml||Standard Error|Mean
1213257|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)|ITT Population|||ml||Standard Error|Mean
1213258|NCT00784550|Primary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)|Intent-to-Treat (ITT) Population: all participants randomized to study drug|||milliliters (ml)||Standard Error|Mean
1213259|NCT00784459|Primary|Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept||3 months||||percentage of cells||Standard Deviation|Mean
1213260|NCT00784459|Primary|Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge|collected prior to randomization to abatacept or placebo|baseline||||percentage of cells||Standard Deviation|Mean
1213261|NCT00784368|Secondary|Number of Participants With Change in the Endoscopy or Image Diagnosis by Diagnosis Name (Centralized Assessment)|Level of Improvement in Endoscopy was assessed as disappeared, decreased, improved, no change, worsened and could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
1213262|NCT00784368|Secondary|Number of Participants With Change In the Endoscopy or Image Diagnosis By Centralized Assessment|Level of Improvement in the Endoscopy or Image diagnosis was assessed as disappeared (if the abnormal findings were normalized), decreased (if level of pathogenic fungus was decreased in culture), improved (if significant improvement was observed in the abnormal findings), no change (if no significant improvement was observed in the abnormal findings), worsened (if the abnormal findings were worsened) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
1213263|NCT00784368|Secondary|Number of Participants With Serologic Effect Against Fungi by Diagnosis Name (Centralized Assessment)|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), worsened (if the test values increased) and could not be assessed (if it was difficult to make above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
1216013|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1213264|NCT00784368|Secondary|Number of Participants With Serological Effect Against Fungi by Centralized Assessment|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), no change (if there was no change in the test values) , worsened (if the test values increased) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
1213265|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Diagnosis Name (Centralized Assessment)|Mycological efficacy was assessed as disappeared, decreased, no change, increased, could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
1213266|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Centralized Assessment|Mycological efficacy was assessed as disappeared (if results for pathogenic fungus became negative, or if it was not possible to obtain the appropriate specimens), decreased (if level of pathogenic fungus was decreased in culture), no change (if there was no quantitative change in pathogenic fungus), increased (if there was a quantitative increase in pathogenic fungus, if results for pathogenic fungus became positive after start of dosing or if new pathogenic fungus was identified) , could not be assessed (if it was difficult to make the above assessment due to lack of detection in tests).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
1213267|NCT00784368|Secondary|Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment)|E.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and number of cases for whom treatment was judged to be ineffective multiplied by 100. T.S.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, number of cases for whom treatment was judged to be ineffective and number of cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||percentage of participants||95% Confidence Interval|Number
1213268|NCT00784368|Secondary|Percentage of Participants With Overall Response by Centralized Assessment|Efficacy rate (E.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and cases for whom treatment was judged to be ineffective multiplied by 100. Treatment success rate (T.S.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, cases for whom treatment was judged to be ineffective and cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
1213269|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment)|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, chronic necrotic pulmonary aspergillosis (C.N.P.A), pulmonary aspergilloma (P.A.) and pulmonary cryptococcosis (P.C).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
1213270|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Centralized Assessment|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
1220405|NCT00732940|Secondary|Absolute Change From Baseline in Triglycerides at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
1213271|NCT00784368|Primary|Time Above Minimum Inhibitory Concentration (T>MIC)|The T>MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||percent time||Standard Deviation|Mean
1213272|NCT00784368|Primary|Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC)|The AUC (0-24) is defined as area under the plasma concentration-time curve over the dosing interval (24 hr). It is usually calculated by linear trapezoidal method. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The AUC 0-24/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||hour||Standard Deviation|Mean
1213273|NCT00784368|Primary|Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC)|The Cmax is maximum observed analyte concentration and MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The Cmax/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||ratio||Standard Deviation|Mean
1213274|NCT00784368|Primary|Minimum Inhibitory Concentration (MIC)|The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||mcg per ml||Standard Deviation|Mean
1213275|NCT00784368|Primary|Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24])|The AUC(0-24) is area under the plasma concentration time curve from time zero (pre-dose) to 24 hours post-dose. It is usually calculated by linear trapezoidal method. AUC was measured in mcg*hour(hr) per ml.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population, for SFI (ITCZ-OS). Here 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||mcg*hr per ml||Standard Deviation|Mean
1213276|NCT00784368|Primary|Maximum Plasma Itraconazole Concentration (Cmax)|The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|Pharmacokinetic (PK) analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population for SFI (ITCZ-OS). 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||mcg/ml||Standard Deviation|Mean
1213277|NCT00784277|Primary|Spontaneous Bowel Movements Per Week (SBMs/Week)|The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.|Week 1 to Week 2|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).|||number of stools/week||Standard Deviation|Mean
1213278|NCT00784277|Primary|5-Day Sum of Pain Intensity Difference (SPID5)|SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where “0” is no pain and “10” is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).|Day 1 to Day 5|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).|||Units on a scale||Standard Deviation|Mean
1213279|NCT00784238|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Millimeter (mm)||Standard Deviation|Mean
1213280|NCT00784238|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Millimeter (mm)||Standard Deviation|Mean
1213281|NCT00784238|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213282|NCT00784238|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213283|NCT00784238|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1213284|NCT00784238|Primary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213285|NCT00784238|Primary|Drug Attitude Inventory (DAI-10) Total Score at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213286|NCT00784238|Primary|Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Social integration subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213287|NCT00784238|Primary|Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213288|NCT00784238|Primary|Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213289|NCT00784238|Primary|Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213290|NCT00784238|Primary|Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213291|NCT00784238|Primary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213292|NCT00784238|Primary|Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Week 24|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1213293|NCT00784147|Secondary|Mean Change From Baseline in CD4+ T-Cell Count at Week 24/EOS|The mean change in CD4+ T-cell count from the Baseline measurement at Week 24/End of Study was summarized at each scheduled time point by treatment group.|Week 24 / End of Study||||cell/mL||Standard Deviation|Mean
1213294|NCT00784147|Secondary|Mean Change From Baseline in Viral Load (log10) at Week 24/EOS|The mean change in HIV-1 RNA (log10) from the Baseline measurement was analyzed at Week 24/End of Study using a generalized linear model at each scheduled study visit.|Week 24 / End of Study||||log10 copies/mL||Standard Deviation|Mean
1213295|NCT00784147|Other Pre-specified|Proportion of Patients With a 0.5 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 0.5 log10 reduction from the Baseline measurement in HIV-1 RNA at Week 24 of the study.|Week 24||||percentage of patients|||Number
1213296|NCT00784147|Other Pre-specified|Proportion of Patients With a 1.0 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 1.0 log10 reduction from Baseline in HIV-1 RNA.|Week 24||||percentage of patients|||Number
1213297|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <400 Copies/mL at Week 24|This efficacy measure was assessed in the same manner as the primary efficacy analysis to determine the proportion of the total population achieving HIV-1 RNA levels <400 copies at Week 24 of the study.|Week 24||||percentage of patients|||Number
1213299|NCT00784147|Primary|The Proportion of Patients Achieving Undetectable Viral Loads at Week 24.|"For the primary efficacy analysis, undetectable was defined as having HIV-1 RNA below the limit of assay detection at <50 copies/mL. The primary efficacy endpoint was analyzed using Fisher exact test. The primary analysis was performed using the ITT population and both the missing data equals treatment failure (MEF) and last observation carried forward (LOCF) methods. The more conservative MEF results are recorded here."|24 weeks||||percentage of participants|||Number
1213300|NCT00784134|Secondary|Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)|Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).|180 days|All the non-missing EuroQol scores at 180 days were analyzed.|||EuroQol score||Standard Deviation|Mean
1213301|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Recovery|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213302|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Participation|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213303|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Emotion|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213304|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Thinking|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213305|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Communication|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213306|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213307|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Hand Function|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213308|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Mobility|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213309|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Strength|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1213310|NCT00784134|Secondary|Functional Status - National Institutes of Health Stroke Scale (NIHSS)|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).|180 days|All the non-missing NIHSS scores at 180 days were analyzed.|||NIHSS score||Inter-Quartile Range|Median
1213342|NCT00784134|Primary|Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
1213311|NCT00784134|Secondary|Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.|180 days|All the non-missing eGOS scores at 180 days were analyzed.|||% of participants with score>=4|||Number
1213312|NCT00784134|Secondary|Functional Status - Barthel Index|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.|180 days|All the non-missing Barthel scores at 180 days were analyzed.|||Barthel score||Standard Deviation|Mean
1213313|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with a non-thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1213314|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with a thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1213315|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size greater than 50ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1213316|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size between 20ml and 50ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1213317|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size less than 20ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1213318|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients over 65 years of age with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
1213319|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients 65 years of age or under with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
1213320|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All male patients with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1213321|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All female patients with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1213322|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)|Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients that reported they were White with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1213323|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)|Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients that reported they were African-American with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
1213324|NCT00784134|Secondary|Predicting Hazards of Death by Treatment Group|Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
1213325|NCT00784134|Secondary|Adverse and Serious Adverse Events|Assessment of number of adverse and serious adverse events by treatment group.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
1213326|NCT00784134|Secondary|Safety/Mortality - Systematic Bleeds Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with systematic bleeds|||Number
1213327|NCT00784134|Secondary|Safety/Mortality - Systematic Bleeds Within 72 Hours|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|72 hours|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with systematic bleeds|||Number
1213328|NCT00784134|Secondary|Safety/Mortality - Bacterial Brain Infections Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with brain infection|||Number
1213329|NCT00784134|Secondary|Safety/Mortality - Mortality Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Percentage of patients|||Number
1213330|NCT00784134|Secondary|Intensity of Critical Care Management - All Infections|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with infections|||Number
1213331|NCT00784134|Secondary|Intensity of Critical Care Management - Pneumonia|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with pneumonia|||Number
1213332|NCT00784134|Secondary|Intensity of Critical Care Management - All Infections|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with infections|||Number
1213333|NCT00784134|Secondary|Intensity of Critical Care Management - Shunts|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with shunts|||Number
1213334|NCT00784134|Secondary|Intensity of Critical Care Management - Pressors|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with pressors|||Number
1213335|NCT00784134|Secondary|Intensity of Critical Care Management - Mechanical Ventilation|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with ventilation|||Number
1213336|NCT00784134|Secondary|Intensity of Critical Care Management - ICP Management|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Percentage of events of ICP >20mmHg|||Number
1213337|NCT00784134|Secondary|Intensity of Critical Care Management - ICU Days|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Number of days||Inter-Quartile Range|Median
1213338|NCT00784134|Secondary|Intensity of Critical Care Management - Hospital Days|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Number of days||Inter-Quartile Range|Median
1213339|NCT00784134|Secondary|Clot Removal (Amount of Residual Blood)|Change in blood volume measured between stability scan and end of treatment scan|72 hours|All patients that were enrolled in CLEAR III were analyzed.|||odds ratio per time-weighted ml|||Number
1213340|NCT00784134|Secondary|All Cause Mortality||180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
1213341|NCT00784134|Primary|Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3|Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|30 days and 180 days|All the non-missing mRS scores at 30 days and 180 days were analyzed.|||Percentage of participants|||Number
1216357|NCT00762762|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.|12 months||||µg/ml||Standard Deviation|Mean
1213343|NCT00784134|Primary|Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
1213344|NCT00784134|Primary|Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||mRS score||Inter-Quartile Range|Median
1213345|NCT00784134|Primary|Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis|Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
1213346|NCT00784095|Primary|QUAL-E Completion Sub-scale|A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
1213347|NCT00784095|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.|Baseline, 6 and 8 week follow ups||||units on a scale||Standard Deviation|Mean
1213348|NCT00784095|Secondary|Center for Epidemiology Studies - Depression Scale (CES-D)|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
1213349|NCT00784095|Secondary|Functional Status ADL|Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.|Baseline, 6 and 8 week follow ups||||units on a scale||Standard Deviation|Mean
1213350|NCT00784095|Primary|Quality of Life - Preparation|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
1213351|NCT00784043|Secondary|Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.|Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children.|5 years|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here.||||||
1213352|NCT00784043|Secondary|Language Acquisition Over Time in Bilaterally Implanted Children.|Scores over time on the MacArthur communicative development inventory.|60 months post initial activation|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here||||||
1213353|NCT00784043|Primary|Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems|Speech perception scores will be compared pre-operatively and postoperatively.|60 months post initial stimulation|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here||||||
1213354|NCT00784030|Primary|Change in Urine cAMP Concentration and Urine Osmolality (UOsm)|Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours|pre- and post-water loading (2 hours)|Number of participants was deemed to be adequate for the purposes of this pilot study|||fold change in cAMP/UOsm (umol/UOsm)||Standard Error|Mean
1213355|NCT00783965|Primary|Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0||Baseline and 36 months||||participants|||Number
1213356|NCT00783965|Primary|Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter||Baseline and 36 months||||participants|||Number
1213357|NCT00783952|Primary|Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations.|Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy.|6 months||||percentage of oxygen saturation||Standard Deviation|Mean
1213358|NCT00783835|Secondary|Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12|It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening.|Screening (Week -2), 4 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213454|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213359|NCT00783835|Secondary|Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale|The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants.|Baseline, Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213360|NCT00783835|Secondary|Clinical Global Impression-Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).|Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213361|NCT00783835|Secondary|Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = Normal, not at all ill and a rating of 7 = Among the most extremely ill participants. Higher scores indicate worsening."|Screening (Week -2), 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213362|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213363|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 4|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213364|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213365|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 8|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213366|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4|Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 4|Intent to treat efficacy evaluation (ITTe) included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1213367|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|5 years|||||||
1213368|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|4 years|||||||
1213619|NCT00782509|Secondary|Weekly Mean of Daily Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each night during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
1213369|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213370|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213371|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213372|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213373|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
1213374|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
1213375|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
1213376|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|5 years|||||||
1213377|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|4 years|||||||
1213378|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213379|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213481|NCT00783796|Secondary|Distal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
1213380|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213381|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213382|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213383|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|4 years|||||||
1213384|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|5 years|||||||
1213385|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213386|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213387|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213388|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213389|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213390|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|5 years|||||||
1213391|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|4 years|||||||
1213392|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213393|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213394|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213395|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213396|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213397|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|5 years|||||||
1213398|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|4 years|||||||
1213399|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213400|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213401|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213402|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213403|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization (TVR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213404|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|5 years|||||||
1213405|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|4 years|||||||
1213406|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213434|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213407|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213408|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213409|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213410|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213411|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|5 years|||||||
1213412|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|4 years|||||||
1213413|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213414|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213415|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213416|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213417|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213418|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|5 years|||||||
1213419|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|4 years|||||||
1213420|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213421|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213422|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213423|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213424|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213425|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|5 years|||||||
1213426|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|4 years|||||||
1213427|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213428|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213429|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213430|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213431|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213432|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|5 years|||||||
1213433|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|4 years|||||||
1216886|NCT00760266|Secondary|Percentage of Responders at Week 4 and Week 8|Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline|At 4 weeks and 8 weeks|Full analysis set|||Percentage of Participants|||Number
1213435|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213436|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213437|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213438|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213439|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|5 years|||||||
1213440|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|4 years|||||||
1213441|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213442|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213443|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213444|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213445|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213446|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
1213482|NCT00783796|Secondary|Proximal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
1213447|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
1213448|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
1213449|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 1123 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213450|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 758 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213451|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 days to 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213452|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|> 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213453|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213483|NCT00783796|Secondary|In-segment % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
1213455|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213456|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213457|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 1123 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213458|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 758 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213459|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|>1 year (Very late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213460|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|31 days - 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213461|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|greater than 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213462|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213463|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|5 years|||||||
1213464|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|4 years|||||||
1213465|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213466|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213467|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213468|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213469|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213470|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|5 years|||||||
1213471|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|4 years|||||||
1213472|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213473|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1213474|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213475|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213476|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1213477|NCT00783796|Secondary|Distal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
1213478|NCT00783796|Secondary|Proximal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
1213479|NCT00783796|Secondary|In-segment Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
1213480|NCT00783796|Secondary|In-stent Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
1213484|NCT00783796|Secondary|In-stent % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
1213485|NCT00783796|Secondary|Distal Late Loss|Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeter||Standard Deviation|Mean
1213486|NCT00783796|Secondary|Proximal Late Loss|Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeter||Standard Deviation|Mean
1213487|NCT00783796|Secondary|In-segment Late Loss (LL)|In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.|240 Days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeters||Standard Deviation|Mean
1213488|NCT00783796|Secondary|In-Stent Late Loss|In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeters||Standard Deviation|Mean
1213489|NCT00783796|Secondary|Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)|Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.|From the start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects.|||Percentage of Participants|||Number
1213490|NCT00783796|Secondary|Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)|Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.|From start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects|||Percentage of Lesions|Participants||Number
1213491|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1213492|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.|||percentage of participants||95% Confidence Interval|Number
1213493|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission."|Week 6 and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1213494|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).~All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1213618|NCT00782509|Secondary|Weekly Mean of Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each 24 hour period during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
1213495|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Response|"Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response."|Baseline, Week 6 and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1213496|NCT00783718|Secondary|Induction Phase: Percentage of Participants With Mucosal Healing at Week 6|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).~All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1213497|NCT00783718|Secondary|Induction Phase: Percentage of Participants in Clinical Remission at Week 6|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1213498|NCT00783718|Primary|Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.|||percentage of participants||95% Confidence Interval|Number
1213499|NCT00783718|Primary|Induction Phase: Percentage of Participants With a Clinical Response at Week 6|"Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical response."|Baseline and Week 6|Induction Study Intent-to-treat (ITT) population which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.|||percentage of participants||95% Confidence Interval|Number
1213500|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1213501|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1213502|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||mmol/L||Inter-Quartile Range|Median
1220406|NCT00732940|Secondary|Median Percent Change From Baseline in Triglycerides at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1213503|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1213504|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||pg/mL||Inter-Quartile Range|Median
1213505|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||pg/mL||Inter-Quartile Range|Median
1213506|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1213507|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1213508|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||umol/L||Inter-Quartile Range|Median
1213509|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
1213510|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
1213511|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
1214742|NCT00773461|Secondary|Time to First Low Disease Activity|Time to Low disease activity was calculated as the number of days from the first dose of drug administration to the date of first achievement of DAS28≤3.2.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Days||95% Confidence Interval|Median
1213512|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||pg/mL||Inter-Quartile Range|Median
1213513|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||pg/mL||Inter-Quartile Range|Median
1213514|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
1213515|NCT00783705|Secondary|Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray||From baseline up to 6 months|Data were not collected due to a study team decision not to analyze this endpoint.||||||
1213516|NCT00783705|Secondary|Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia||From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.|||percentage of Ki67 expression level||Standard Deviation|Mean
1213517|NCT00783705|Secondary|Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment|The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.|||percentage change in number of lesions||Standard Deviation|Mean
1213518|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.|"The definitions of responses are:~Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease"|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.|||percentage of participants|||Number
1213519|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.|"The definitions of responses are:~Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression."|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.|||percentage of participants|||Number
1213520|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission"|Assessed every 4 weeks from Week 6 to Week 50, and at Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1213521|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52|"Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.|||percentage of participants||95% Confidence Interval|Number
1213531|NCT00783432|Primary|Number of Participants Reporting Adverse Events|An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.|12 months|Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.|||Participants|||Number
1213522|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1213523|NCT00783692|Secondary|Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6|C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).|Baseline and Week 6|Induction Study ITT Population; last observation carried forward (LOCF) imputation was used. Baseline CRP was missing for one participant in the placebo group.|||mg/L||Full Range|Median
1213524|NCT00783692|Primary|Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52|"Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.|||percentage of participants||95% Confidence Interval|Number
1213525|NCT00783692|Primary|Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1213526|NCT00783692|Primary|Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study Intention to Treat (ITT) Population, which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.|||percentage of participants||95% Confidence Interval|Number
1213527|NCT00783614|Primary|Blood Markers of Inflammation, Endothelial Injury, and Thrombosis||changes from baseline to 6 months|Data measurements not obtained, as study terminated early due to poor enrollment||||||
1213528|NCT00783614|Primary|Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events|At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication|6 months|The number of participants with adverse events or reporting side effects|||participants|||Number
1213529|NCT00783432|Secondary|Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.|The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.|baseline, months 1,3,6,9 and 12/or early termination|Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.|||Units on a scale||Standard Deviation|Least Squares Mean
1213530|NCT00783432|Primary|Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.|Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.|baseline and 12 months/ET||||Participants|||Number
1213532|NCT00783302|Secondary|Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.|"The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration.~This outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration."|Within 1 month, 6 months and 12 months post contrast administration.||||Number of Subjects|||Number
1213533|NCT00783302|Primary|The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
1213534|NCT00783302|Primary|The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
1213535|NCT00783302|Primary|The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
1213536|NCT00783302|Primary|The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|The subject follow-up period went from 1 month, 6 months and 12 months.|||Percentage of Subjects||95% Confidence Interval|Number
1213537|NCT00783263|Secondary|Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels|Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.|Baseline to 6 weeks||||percentage change||Standard Deviation|Mean
1213538|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl|Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).|6 weeks of treatment||||participants|||Number
1213539|NCT00783263|Secondary|Number of Participants Who Reached the LDL-C Level of <70 mg/dl|Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|6 weeks of treatment||||participants|||Number
1213540|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached Their Target LDL-C Level|Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.|6 weeks of treatment||||participants|||Number
1213541|NCT00783263|Secondary|Number of Participants Who Reached Their Target LDL-C Level|Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.|6 weeks of treatment||||participants|||Number
1213542|NCT00783263|Secondary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks||||percentage change||Standard Deviation|Mean
1213543|NCT00783263|Primary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks||||percent change||Standard Deviation|Mean
1213544|NCT00783224|Primary|Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks|The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.|Baseline to 2 weeks of treatment||||Units on a scale||Standard Error|Least Squares Mean
1217035|NCT00759096|Primary|Near Uncorrected Visual Acuity(UCVA|Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.|6 months after surgery of 2nd eye||||logMAR||Standard Deviation|Mean
1213545|NCT00783198|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36, with a lower score indicating less rhinoconjuntivitis medication use. Raw means for DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
1213546|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
1213547|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
1213548|NCT00783198|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
1213549|NCT00783198|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (ANOVA) model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to Good Clinical Practice (GCP) issues.|||score on a scale||Standard Error|Mean
1213550|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint|Post residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||milliliter||Standard Deviation|Mean
1213551|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||microgram/liter||Standard Deviation|Mean
1213552|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 54-Week Endpoint||Baseline, 54-weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||beats per minute (bpm)||Standard Deviation|Mean
1213553|NCT00783094|Secondary|Change From Baseline in Blood Pressure During at 54-Week Endpoint||Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1213554|NCT00783094|Secondary|Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment|A listing of Adverse Events are reported in the Reported Adverse Event Section.|End of 12 weeks of double-blind through 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||participants|||Number
1213555|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1213556|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1213557|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1213558|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 54 weeks|All participants enrolled in the open-label phase who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1213559|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1213560|NCT00783094|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1213561|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 12 weeks|Safety Analysis Set: All randomized participants who received study treatment grouped by the treatment actually taken.|||Micrograms per liter||Standard Deviation|Mean
1213562|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint|Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||milliliters||Standard Deviation|Mean
1213563|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 12-Week Endpoint||Baseline, 12 Weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||beats per minute||Standard Deviation|Mean
1213564|NCT00783094|Secondary|Change From Baseline in Blood Pressure at 12-Week Endpoint||Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||mmHg||Standard Deviation|Mean
1213565|NCT00783094|Secondary|Number of Participants With Adverse Events During 12 Weeks of the Study|A listing of Adverse Events are reported in the Reported Adverse Event Section.|Baseline through 12 weeks|All randomized participants|||participants|||Number
1213566|NCT00783094|Secondary|Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement|Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.|Baseline, 12 weeks|Participants who received 2.5 mg or 5 mg tadalafil once daily during the double-blind period.|||nanogram/milliliter||Standard Deviation|Geometric Mean
1213567|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||milliliters per second||Standard Error|Least Squares Mean
1213568|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1213569|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1213570|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1213571|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1213603|NCT00782639|Secondary|The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)|This outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||Participants|||Number
1213572|NCT00783094|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1213573|NCT00782834|Primary|Response Rate|Response rate of nilotinib by RECIST criteria evaluated every 2 months for the first 6 months then every 3 months for the duration of treatment period.|1year||||Participants|||Number
1213574|NCT00782834|Primary|Progression Free Survival Rate at 6 Months|Number of participants that demonstrate progression free survival at 6 months|6 months||||Participants|||Number
1213575|NCT00782821|Secondary|Patient Allograft Survival at 12 Months|Patient's allograft was still functioning at 12 months post study enrollment|12 months||||participants|||Number
1213576|NCT00782821|Secondary|Patient Survival at 12 Months|Patient was still alive 12 months post study enrollment.|12 months||||participants|||Number
1213577|NCT00782821|Secondary|Acute Cellular Rejection by Banff '97 Criteria (Updated 2005)|"Acute cellular rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months||||participants|||Number
1213578|NCT00782821|Secondary|Antibody-mediated Rejection by Banff '97 Criteria (Updated 2005)|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria. Rejection due, at least in part, to documented anti-donor antibody (‘suspicious for’ if antibody not demonstrated); may coincide with categories 3, 4 and 5.~Grade I. ATN-like – C4d+, minimal inflammation Grade II. Capillary- margination and/or thromboses, C4d+ Grade III. Arterial – v3, C4d+"|6 months||||participants|||Number
1213579|NCT00782821|Primary|Incidence of Acute Rejection (Banff ’97) or Antibody Mediated Rejection|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria.~Acute rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months||||participants|||Number
1213580|NCT00782795|Secondary|Insulin Sensitivity (%S)|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/;|24 and 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||insulin sensitivity (%)||Standard Deviation|Mean
1213581|NCT00782795|Secondary|Missed Work|Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks)|12, 24, 36, 48, 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||days||Standard Deviation|Mean
1213582|NCT00782795|Secondary|Hospitalizations|Mean number of hospitalizations within the prior 12 weeks|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||hospitalizations||Standard Deviation|Mean
1213583|NCT00782795|Secondary|Body Mass Index (BMI)|standard BMI defined as mass in kilograms divided by height in meters squared|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||kg/m^2||Standard Deviation|Mean
1213584|NCT00782795|Secondary|Pain|"Pain is reported as the mean of four Visual analogue scales, ranging from 0 points (no pain) to 100 points (severe pain)~What is your pain right now?~What is your typical or average pain in the last 12 weeks?~What is your pain level at its best in the last 12 weeks (how close to “0” does your pain get at its best)?~What is your pain level at its worst in the last 12 weeks (how close to “0” does your pain get at its worst)?"|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||units on a scale||Standard Deviation|Mean
1213585|NCT00782795|Secondary|Number and Percentage of Participants With Steatorrhea|Participants were counted as having steatorrhea if they had either a) positive qualitative fecal fat; or b) 72 hour quantitative fecal fat result with >7g fat in stool in 24hours|48 weeks||||Participants|||Count of Participants
1213586|NCT00782795|Secondary|Quality of Life|The SF36 (Short Form with 36 questions) QoL scoring system has 36 questions, comprising two main dimensions (Physical Health and Mental Health), further divided by 8 independent scales (Physical functioning, Role-Physical, Bodily pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health). The scales for general health and mental health overlap components of both the two main dimensions (Physical Health and Mental Health). The scales, including the total score and dimensions are scored as a number between 0 and 100, where 0 represents lower limits of functioning and 100 is best functioning possible. Data reported is the average total score.|24, 48 weeks|The 24 week data has two participants' data missing from each arm because it was not available.|||units on a scale||Standard Deviation|Mean
1213604|NCT00782639|Primary|The Number of Participants With Contrast-induced Nephropathy (CIN)|The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|48 to 72 hours After Injection of Contrast Media||||Participants|||Number
1220407|NCT00732940|Secondary|Median Percent Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1213587|NCT00782795|Secondary|Pancreas Ultrasound Appearance|"Mean score on a scale of 0 - 10: count of positive Endoscopic Ultrasound(EUS) features:~Parenchymal Features - Only Body and Tail~Calcification (>3 hyperechoic foci >2 mm length & width with shadowing)~Lobularity (>3 well-circumscribed, >5mm structures)~Hyperechoic stranding (>3 hyperechoic lines >3mm in length, seen in > 2 different directions with respect to the imaged plane Parenchymal Features - Head, Body and Tail~Cyst (>2 mm diameter anechoic round or oval structure)~Hyperechoic foci (>3 reflectors, >3 mm long & wide, no shadowing) Ductal Features - Only Body and Tail~Side Branch Dilation (>3 tubular, anechoic, >1 mm structures,Main pancreatic duct (MPD) connects)~Irregular MPD contour (uneven and ectatic in its course)~Hyperechoic MPD margin (hyperechoic in >50% of MPD)~Dilation MPD (>3.5 mm body, >1.5 mm tail*) Ductal Features - Head, Body and Tail~MPD calculi (hyperechoic foci with shadowing contained within MPD)"|48 weeks||||units on a scale||Inter-Quartile Range|Median
1213588|NCT00782795|Secondary|Insulin Resistance at 24 and 48 Weeks|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/|24, 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||HOMA2-IR||Standard Deviation|Mean
1213589|NCT00782795|Secondary|Beta-cell Function|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/|24, 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||Beta-cell function (%)||Standard Deviation|Mean
1213590|NCT00782795|Primary|Insulin Sensitivity Index for Glycemia at 48 Weeks.|"Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).~GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.~INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin."|48 weeks||||numeric index||Standard Deviation|Mean
1213591|NCT00782795|Primary|Insulin Sensitivity Index for Glycemia at 24 Weeks|"Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).~GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.~INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin."|24 weeks||||numeric index||Standard Deviation|Mean
1213592|NCT00782795|Primary|Glucose Tolerance at 48 Weeks|"Normal = normal plasma glucose and normal glucose tolerance (OGTT).~Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.~Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl."|48 weeks||||Participants|||Count of Participants
1213593|NCT00782795|Primary|Glucose Tolerance at 24 Weeks|"Normal = normal plasma glucose and normal glucose tolerance (OGTT).~Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.~Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl."|24 weeks||||Participants|||Count of Participants
1213594|NCT00782756|Secondary|Neurocognitive Outcome||through study completion, an average of 1 year|37 participants agreed to undergo neuropsychological evaluations.|||Participants|||Count of Participants
1213595|NCT00782756|Secondary|Progression Free Survival||through study completion, an average of 1 year||||months||Full Range|Median
1213596|NCT00782756|Primary|Number of Participants With Adverse Events|Safety assessments and toxicity grading will follow CTCAE Version 4 Grade|through study completion, an average of 1 year||||Participants|||Count of Participants
1213597|NCT00782717|Secondary|Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).|BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.|From Day 7 to Day 90 (or Early Exit)|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).|||Percentage of patients|||Number
1213598|NCT00782717|Primary|Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery|Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).|3 Months|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).|||Percentage of patients|||Number
1213599|NCT00782639|Primary|Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit|Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||milligrams per deciliter (mg/dL)|||Number
1213600|NCT00782639|Secondary|Number of Participants Who Died From Acute Renal Failure|This outcome measure provides the total number of participants who died as a result of acute renal failure.|Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)||||Participants|||Number
1213601|NCT00782639|Secondary|Number of Participants Requiring Dialysis|This outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure.|48 to 72 hours after injection of contrast media||||Participants|||Number
1213602|NCT00782639|Secondary|The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)|This outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||Participants|||Number
1213617|NCT00782509|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS|||Point on scale||Standard Error|Mean
1213605|NCT00782626|Primary|Overall Response|Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy.Description: Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy. Response for target lesions (up to5) is based on 3 dimensions with an elliptical model volume used: 0.5L*W*T; (L) tumor extent in plane perpendicular to the selected plane; (W) longest measurement of the tumor width; (T) transverse measurement perpendicular to the width. CR is disappearance all target and non-target lesions and no new lesions. PR is >/= 65% decrease in sum of the products (referent baseline). PD 40% or more increase in any target lesion (referent smallest product observed on therapy). SD is none of the above. PR and SD classification as long as absent new lesions and unequivocal progression for non-target lesions else PD.|Disease evaluations (MRI brain, including volumetric analysis) occurred at baseline, at the end of course 1, every 3 courses during treatment up to 12 courses and at early treatment discontinuation.|The analysis dataset is comprised of all evaluable patients. All treated patients were evaluable.|||participants|||Number
1213606|NCT00782509|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.|||mmol/L||Standard Deviation|Mean
1213607|NCT00782509|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.|||percentage of participants|||Number
1213608|NCT00782509|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Mean number of moderate COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
1213609|NCT00782509|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Mean number of COPD exacerbations requiring hospitalization per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
1213610|NCT00782509|Secondary|Number of COPD Exacerbations|Mean number of COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
1213611|NCT00782509|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol.Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval..|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1213612|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1213613|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank.~The measured values presented are actually the First Quartile and 95% confidence interval."|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1213614|NCT00782509|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS|||Point on scale||Standard Error|Mean
1213615|NCT00782509|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS|||Point on scale||Standard Error|Mean
1213616|NCT00782509|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS|||Point on scale||Standard Error|Mean
1213620|NCT00782509|Secondary|Weekly Mean of Daily Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each day during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
1213621|NCT00782509|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS|||L/min||Standard Error|Mean
1213622|NCT00782509|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS|||L/min||Standard Error|Mean
1213623|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
1213624|NCT00782509|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1213625|NCT00782509|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1213626|NCT00782509|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1213627|NCT00782509|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1213628|NCT00782509|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1213629|NCT00782509|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours aftertreatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1213648|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1213630|NCT00782509|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
1213631|NCT00782509|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
1213632|NCT00782509|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
1213633|NCT00782509|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
1213634|NCT00782509|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
1213635|NCT00782509|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS|||Liter||Standard Error|Mean
1213636|NCT00782509|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
1213637|NCT00782509|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
1213638|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1213639|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1213640|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1213641|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1213642|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1213643|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1213644|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1213645|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1213646|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1213647|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1213667|NCT00782483|Primary|Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.|Three treatments up to one year, whichever is first|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.||||||
1213649|NCT00782509|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1213650|NCT00782509|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
1213651|NCT00782509|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
1213652|NCT00782509|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
1213653|NCT00782509|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
1213654|NCT00782509|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
1213655|NCT00782509|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
1213656|NCT00782509|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
1213657|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1213658|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1213659|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1213660|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1213661|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1213662|NCT00782509|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
1213663|NCT00782509|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS|||Liter||Standard Error|Mean
1213664|NCT00782509|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.|||Liter||Standard Error|Mean
1213665|NCT00782496|Secondary|Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2|Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.|Over six month period|63 surveys were available for analysis.|||percent of Level 2 participants|||Number
1213666|NCT00782496|Primary|Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features||6 months|For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available.|||number of post-prandial tests per week||Standard Error|Mean
1213670|NCT00782418|Primary|Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose|"Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate.~Insulin Secretion Rate (ISR)/ Blood Glucose (BG)"|Steady-state of HGC: 90 – 120 minutes post dose; highest glucose infusion rate of GGI: 120 – 160 minutes post dose|All subjects treated|||(ng/min) / (mg/dL)||Full Range|Geometric Mean
1213671|NCT00782379|Secondary|Disease Free Survival at Day 100|Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.|Day 100|17 patients were alive at Day 100 and therefore were eligible to be evaluated for disease free survival at D100|||participants|||Number
1213672|NCT00782379|Secondary|Disease Free Survival at 12 Months|Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.|12 months|14 patients were alive at one year and therefore were eligible to be evaluated for disease free survival at 1 year|||participants|||Number
1213673|NCT00782379|Secondary|Overall Survival at 12 Months|Overall survival, defined as a patient being alive after transplant, is without regard to disease status.|12 months|20 patients received haploidentical transplant and therefore were eligible to be evaluated for overall survival at 1 year|||participants|||Number
1213674|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|13 patients had chimerism drawn at Day 90|||participants|||Number
1213675|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 60|18 patients had chimerism drawn at Day 60|||participants|||Number
1213676|NCT00782379|Secondary|Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)||Day 100|2 patients died before Day 100 and therefore are eligible to be evaluated for non-relapse mortality|||participants|||Number
1213677|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|18 patients had Day 30 chimerism drawn|||participants|||Number
1213678|NCT00782379|Secondary|Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)|Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.|1 year|6 patients died prior to one year and therefore are eligible to be evaluated for non-relapse mortality.|||participants|||Number
1213679|NCT00782379|Secondary|Overall Survival at Day 100|Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.|Day 100|20 patients received a haploidentical transplant and therefore are eligible to be evaluated for Day 100 survival|||participants|||Number
1213680|NCT00782379|Primary|Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)|Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence|Day 100|17 patients were alive at Day 100 and eligible to be evaluated for grade 3-4 graft versus host disease|||participants|||Number
1213681|NCT00782379|Primary|Incidence of Graft Rejection for Patients at Day 100|Number of patients who experienced graft rejection by Day 100|Day 100|20 patients were treated and able to be analyzed for graft rejection|||participants|||Number
1213682|NCT00782340|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. A positive score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days||||mmHg||Standard Deviation|Mean
1213683|NCT00782340|Secondary|Clinician-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days||||participants|||Number
1213684|NCT00782340|Secondary|Patient-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days||||participants|||Number
1213685|NCT00782340|Secondary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1213686|NCT00782340|Secondary|Change in Activities Involving Walking a Short Time (OHDAS Item 3)|OHDAS Item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1213687|NCT00782340|Secondary|Change in Activities Involving Standing a Short Time (OHDAS Item 1)|OHDAS Item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1213688|NCT00782340|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score|OHSA composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1213689|NCT00782340|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|OHDAS composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1213690|NCT00782340|Primary|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from randomization, negative numbers represent improvement from randomization in OHQ score."|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1213691|NCT00782288|Secondary|Clinically Significant Changes in the Microbiology of Sputum in Subjects|Count of clinically significant changes in sputum microbiology during the Treatment phase (Day 1 to Day 28) to include any new acquisition of B. cepacia or new acquisition of any multiple resistant organism.|28 days|There were no significant changes in the microbiology of sputum in any subjects over the course of treatment.|||participants|||Number
1213692|NCT00782288|Secondary|Clinically Significant Alterations in ECG Readings|Safety indices included an assessment for the number of clinically significant alterations in the subjects ECG readings from Day 1 to Day 28.|28 days|Count of clinically significant alterations in the ECG in all subjects during the Treatment Phase of the study.|||participants|||Number
1213693|NCT00782288|Secondary|Number of CF Subjects With Microarray Results From Nasal Epithelial Cells to Measure the Effect of Digitoxin on Gene Expression.|Rhinoprobe was used to collect nasal epithelial cells. The cells were collected pre and post-treatment and placed in Trizol for RNA isolation then used to measure the effect of digitoxin on gene expression. The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). The accession number for that data is GSE76347 (data available Dec 2018).|Day 0 and Day 28|The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). Results can be found under the accession number GSE76347. One subject's pair of specimens in the placebo group was not collected.|||participants|||Number
1213694|NCT00782288|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period.|Median change in serum ESR (mm/hr) and IQR was calculated from Treatment Period (28 days).|Baseline and Day 28|All subjects had blood labs for ESR drawn on Visits 1,3,4 and 5. The changes in median ESR were calculated during the Treatment Period (28 days).|||mm/hr||Inter-Quartile Range|Median
1213695|NCT00782288|Secondary|Changes in C Reactive Protein (CRP) During Treatment.|Median changes in CRP and IQR were assessed from serum samples collected at Visits 1,3, 4 and 5.|Baseline and Day 28|All subjects had blood labs for CRP drawn on Visits 1,3,4 and 5. The changes in median CRP were calculated during the Treatment Period (28 days).|||mg/dL||Inter-Quartile Range|Median
1213696|NCT00782288|Primary|Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period).|The change in log 10 neutrophil cell count from Day 28 minus Day 1 (during the treatment period) expressed as log (10^4 neutrophil/mL).|28 days (Day 28 minus Day 1)|The change in neutrophil cell count from Day 1 to Day 28 was performed using a Kruskal-Wallis equality of populations rank test. The cells counts are expressed as log 10 (neutrophil cell/mL).|||log 10 (neutrophil cell/mL)||Inter-Quartile Range|Median
1213697|NCT00782288|Primary|Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The neutrophil counts were measured in the induced sputum of participants in each group on study 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1- Day 42)|Neutrophil cell counts were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between the placebo and the two digitoxin dose levels.|||log 10 (neutrophil cells/mL)||Inter-Quartile Range|Median
1213698|NCT00782288|Primary|Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period).|Change in Il-8 values are expressed as a change in log 10 Il-8 pg/mL from Day 28 minus Day 1.|28 days (Day 28 minus Day 1)|For change in Il-8 from Day 28 minus Day 1, a Kruskal-Wallis equality of populations rank was performed.|||log10 (pg/mL)||Inter-Quartile Range|Median
1213699|NCT00782288|Secondary|Change in WBC (White Blood Cell) Count by Group During Treatment Period|Safety indices included changes in FEV1 (lung function), changes in WBC, alterations in ECG and sputum microbiology. There were no significant alterations in the ECG in any subjects over the course of the study. There were no subjects who acquired multiple resistant changes in microbiology of sputum and no acquisition of B. cepacia in any subjects. Therefore, these data were not analyzed. The median changes in FEV1 and median changes in WBC, ESR and CRP are reported.|Baseline and Day 28|Safety indices included changes in WBC during treatment for each group.|||K/cu mm||Inter-Quartile Range|Median
1213712|NCT00782210|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1213700|NCT00782288|Secondary|Mean Change in Quality of Life Scores, for Each Domain, From Day 1 to Day 42 Using the Cystic Fibrosis Questionnaire Revised (CFQ-R).|"CFQ-R is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms. Developed specifically for use in patients with a diagnosis of cystic fibrosis. There are 9 Quality of life domains: physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions and 3 symptom scales: weight, respiratory, and digestion.~Scaling of items is done via 5 distinct 4-point Likert scales. Scores for each domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. Based on clinician judgment of global clinical change, a moderate change was a standardized effect size of 0.50 units and an important change was a standardized effect size of 0.80 units evaluating pre- and post-treatment for CF exacerbation. Mean changes in CFQ-R Scores by Group were evaluated between Visit 6 and Visit 1, by Domain."|Baseline and Day 42|Mean change in CFQ-R scores from Visit 1 to Visit 6, by domain.|||mean change of scores on a scale||Standard Deviation|Mean
1213701|NCT00782288|Secondary|Safety Indices Including Change in FEV1 in Stable CF Patients.|Safety indices included changes in FEV1 (forced expiratory volume in 1 second), changes in WBC (white blood cell count), alterations in ECG and sputum microbiology. The median changes in FEV1 are reported.|Baseline and Day 28|Median changes in FEV1 in L by group for the 28 days of treatment.|||liters||Inter-Quartile Range|Median
1213702|NCT00782288|Secondary|Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients.|Digitoxin serum levels were drawn on Days 1 (pre-dose), 7, 14, 21 and 42. The range of digitoxin levels for each visit is listed and the number of subjects who had that level are marked by group (placebo, low dose and high dose).|Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42|Subjects had serum digitoxin levels drawn at Day 1 (pre-dose) with no levels observed, as expected. Digitoxin was drawn on Day 7, 14, 21 and 42 to determine the number of subjects with a detectable level of digitoxin (ng/mL) in serum by group.|||participants|||Number
1213703|NCT00782288|Primary|Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The Il-8 measurements of sputum digitoxin levels for each group is shown for 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1 to Day 42)|Sputum was collected for Il-8 biomarkers on Days 1,14, 21, 28 during the treatment phase and at Day 42. Measures were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between placebo and the two doses.|||log 10 (pg/mL)||Inter-Quartile Range|Median
1213704|NCT00782275|Secondary|Overall Survival|Overall survival (OS) is defined from the date of registration to date of death, or censored at the date the participant was last known alive. OS is estimated based on the Kaplan-Meier method.|Median follow-up for survival in this study cohort is 56 months.|The analysis dataset is comprised of all treated participants.|||months||90% Confidence Interval|Median
1213705|NCT00782275|Secondary|Objective Response Rate|Objective response (OR) rate is the percentage of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment; Treatment continued until disease progression or unacceptable toxicity. Median (range) of treatment duration for this study cohort was 5 cycles (1-39) [1 cycle=28days].|The analysis dataset is comprised of all treated participants.|||percentage of participants||90% Confidence Interval|Number
1213706|NCT00782275|Primary|4-month Progression-Free Survival Rate|4-month progression-free survival rate was defined as the percentage of participants absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment. Relevant for this endpoint was disease status at 4 months.|The analysis dataset is comprised of all treated participants.|||percentage of participants||90% Confidence Interval|Number
1213707|NCT00782210|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.|||mmol/L||Standard Deviation|Mean
1213708|NCT00782210|Secondary|Changes in Safety Parameters Related to Treatment|Occurrence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.|||percentage of participants|||Number
1213709|NCT00782210|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.||||Number of COPD exacerbations||Standard Error|Mean
1213710|NCT00782210|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD exacerbations||Standard Error|Mean
1213711|NCT00782210|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD exacerbations||Standard Error|Mean
1213713|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1213714|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1213715|NCT00782210|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS|||Point on scale||Standard Error|Mean
1213716|NCT00782210|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS|||Point on scale||Standard Error|Mean
1213717|NCT00782210|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS|||Point on scale||Standard Error|Mean
1213718|NCT00782210|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS|||Point on scale||Standard Error|Mean
1213719|NCT00782210|Secondary|Weekly Mean Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
1213720|NCT00782210|Secondary|Weekly Mean Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
1213721|NCT00782210|Secondary|Weekly Mean Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
1213722|NCT00782210|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS|||L/min||Standard Error|Mean
1213723|NCT00782210|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS|||L/min||Standard Error|Mean
1213724|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
1213725|NCT00782210|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1213726|NCT00782210|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1213727|NCT00782210|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1213728|NCT00782210|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1213729|NCT00782210|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1213730|NCT00782210|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1213731|NCT00782210|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
1213732|NCT00782210|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
1213733|NCT00782210|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
1213734|NCT00782210|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
1213735|NCT00782210|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
1214367|NCT00775658|Primary|The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.||at baseline and at return visit (between study day 7-10)|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.|||cm2||Standard Deviation|Mean
1213736|NCT00782210|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS|||Liter||Standard Error|Mean
1213737|NCT00782210|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
1213738|NCT00782210|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
1213739|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1213740|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1213741|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1213742|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1213743|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1213744|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1214368|NCT00775658|Primary|The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.||at baseline and at return visit (between study day 7-10)||||cm2||Standard Deviation|Mean
1213745|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1213746|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1213747|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1213748|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1213749|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1213750|NCT00782210|Secondary|Peak FEV1 (0-3h) Response At Day 1|"Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.~Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by- visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect."|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1213751|NCT00782210|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
1213752|NCT00782210|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
1213753|NCT00782210|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
1213775|NCT00782184|Secondary|Percent Change From Baseline in Triglycerides||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213754|NCT00782210|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
1213755|NCT00782210|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
1213756|NCT00782210|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
1213757|NCT00782210|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
1213758|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1213759|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1213760|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1213761|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1213776|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213762|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|FAS|||Liter||Standard Error|Mean
1213763|NCT00782210|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
1213764|NCT00782210|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS|||Liter||Standard Error|Mean
1213765|NCT00782210|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.|||Liter||Standard Error|Mean
1213766|NCT00782184|Secondary|Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213767|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B/A-1 Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213768|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein A-1||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213769|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213770|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213771|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213772|NCT00782184|Secondary|Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213773|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213774|NCT00782184|Secondary|Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213777|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <100 mg/dL|Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
1213778|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <77 mg/dL|Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
1213779|NCT00782184|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL)-C||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1213780|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goals of <70 mg/dL|Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
1213781|NCT00782171|Secondary|Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events|Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)|until the 3 year post-surgery|All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled|||number of events|||Number
1213782|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|3 years post-surgery||||implants|Number of Implants||Number
1213783|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|2 years post-surgery|The analysis was based on implants as observational unit. The 2-year data was analyzed together with the 3-year data. Our statistical analysis for 2-year time point included how many implants were available but not how many participants.|||implants|Number of Implants||Number
1213784|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|1 years post-surgery||||implants|Number of Implants||Number
1213785|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|20-23 weeks post-surgery||||implants|Number of Implants||Number
1213786|NCT00782171|Secondary|Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected|Patients affected by AE Patients affected by related/ unknown AE|until the 3 year post-surgery|All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled|||patients affected|||Number
1213787|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|3 years post-surgery||||implants|Number of Implants||Number
1213788|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|2 years post-surgery||||implants|Number of Implants||Number
1213789|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|1 year post-surgery|Number of implants placed. Implants from drop-outs are not included|||implants|Number of implants||Number
1213790|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation|20-23 Weeks post-surgery||||implants|Implants||Number
1213791|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 3 years post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
1213792|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 2 years post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
1213793|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 1 year post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
1213794|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
1213795|NCT00782067|Secondary|Histopathologic Response|Histopathologic response was summarized to demonstrate the change from baseline in percentage of mast cell infiltrations in the Bone Marrow (BM) and related serum tryptase levels.|Up 5 years|Primary Efficacy Population (PEP); for each patient, the best improvement relative to Baseline was considered.|||Percentage of participants|||Number
1213796|NCT00782067|Secondary|Long-term Safety and Tolerability of Midostaurin|Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)|Up to 30 days after last dose of study treatment|Safety Set (SS)|||Percentage of participants|||Number
1213797|NCT00782067|Secondary|Median Time to Overall Survival (OS)|The Overall Survival (OS) is defined as the time from start of treatment to the date of death due to any cause.|Up 5 years|Primary Efficacy Population (PEP), which consisted of all participants with a confirmed response and the Full Analysis Set (FAS), which consisted of all patients who received at least one dose of study drug were considered.|||Months||95% Confidence Interval|Median
1213798|NCT00782067|Secondary|Median Time to Progression-Free Survival (PFS)|The Progression-free survival (PFS) is defined as the time from start of treatment to the date of the first documented and confirmed progression or death due to any cause.|Up 5 years|Primary Efficacy Population (PEP), which consisted of all participants with a confirmed response, was considered.|||Months||95% Confidence Interval|Median
1213799|NCT00782067|Secondary|Median Time to Response (TTR)|The Time to response (TTR) was defined as the time from start of treatment until the date of onset of confirmed response (MR or PR).|Up 5 years|Primary Efficacy Population (PEP), which consisted of all participants with a confirmed response, was considered.|||Months||Full Range|Median
1213800|NCT00782067|Secondary|Median Time to Duration of Response (DoR)|The Duration of response (DoR) was defined as the time from first onset of confirmed response (MR or PR) to the date of first documented and confirmed progression or death due to ASM/MCL.|Up 5 years|Primary Efficacy Population (PEP), which consisted of all participants with a confirmed response, was considered.|||Months||95% Confidence Interval|Median
1213801|NCT00782067|Primary|Percentage of Participants With Overall Response Rate (ORR)|"Overall Response Rate (ORR) was defined as the percentage of participants who classified as confirmed responders (Major Response (MR) or Partial Response (PR)) by the adjudication of the SSC and based on a Modified Valent Criteria.~A major responder had complete resolution of at least one C-Finding and no progression in other C-Findings. A partial responder showed a measurable improvement in one or more C-Finding(s) without confirmed progression in other C-Findings. A C-Finding was a Clinical Finding, which was considered by the investigator and corroborated by the Study Steering Committee (SSC) Chairperson or designee, attributable to the mast cell disease component and not the associated hematological clonal non-mast cell lineage disease (AHNMD) component or any other cause."|6 months|Primary Efficacy Population: participants assigned to study treatment who met diagnostic criteria for aggressive systemic mastocytosis or mast cell leukemia and presented with at least 1 measurable C-Finding at study entry and/or participants with transfusion dependent anemia due to their underlying disease at study entry as confirmed by the SCC.|||Percentage of participants||95% Confidence Interval|Number
1213802|NCT00781963|Primary|Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 – 21. A total score > 8 indicates poor sleep quality.|Six months after baseline assessment||||units on a scale||Standard Deviation|Mean
1213803|NCT00781963|Primary|Sleep Efficiency|Calculated from 7-day sleep diary|Six months after baseline assessment|||||||
1213804|NCT00781950|Secondary|Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.||1 year||||mmHg||Standard Error|Mean
1213805|NCT00781950|Primary|Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions||1 year||||participants|||Number
1213806|NCT00781937|Secondary|Binge Eating Scale Scores by Week and Severity|Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)|Week 0, week 50 and week 57|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||scores on a scale||Standard Deviation|Mean
1213807|NCT00781937|Secondary|Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)|Number of subjects using concomitant medications at Week 0 and Week 56, respectively|Week 0 and week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||Subjects|||Number
1213808|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)|Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage point||Standard Error|Least Squares Mean
1213809|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||pmol/L||Standard Error|Least Squares Mean
1214034|NCT00779311|Secondary|Determination of Progression Free Survival (PFS) Among Patients on This Regimen|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first.||||Months||95% Confidence Interval|Median
1213810|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
1213811|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)|Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||proportion||Standard Error|Least Squares Mean
1213812|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)|Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percent change||Standard Error|Least Squares Mean
1213813|NCT00781937|Secondary|Change From Baseline in Body Mass Index (BMI)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg/m^2||Standard Error|Least Squares Mean
1213814|NCT00781937|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||cm||Standard Error|Least Squares Mean
1213815|NCT00781937|Secondary|Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56|Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.|Week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1213816|NCT00781937|Secondary|Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||nmol/L||Standard Error|Least Squares Mean
1213817|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Total Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
1213818|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
1213819|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Triglycerides|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
1213820|NCT00781937|Secondary|Change From Baseline in Pulse||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||beats/minute||Standard Error|Least Squares Mean
1213821|NCT00781937|Secondary|Change From Baseline in Blood Pressure||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmHg||Standard Error|Least Squares Mean
1213822|NCT00781937|Secondary|Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 68|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg||Standard Error|Least Squares Mean
1213823|NCT00781937|Secondary|Change From Baseline in Fasting Weight|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg||Standard Error|Least Squares Mean
1213824|NCT00781937|Secondary|Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1214047|NCT00779142|Secondary|Number of Participants With Increase in Visual Acuity (VA) Two Lines or More at the End of One Month After the Last Intraocular Injection||1 month||||Participants|||Count of Participants
1213825|NCT00781937|Secondary|Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1213826|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1213827|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1213828|NCT00781937|Secondary|Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1213829|NCT00781937|Primary|Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1213830|NCT00781937|Primary|Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0|Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1213831|NCT00781937|Primary|Mean Percentage Change in Fasting Body Weight From Baseline|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage||Standard Error|Least Squares Mean
1213832|NCT00781911|Secondary|Pharmacodynamics Markers; Concentration of Insulin-like Growth Factor I, II (IGF-I, IGF-II), IGF Body Fat (IGFBF)-1 and IGFBF-2||18 months|Zero participants were analyzed due to no data collection due to low number of clinical responses observed.||||||
1213833|NCT00781911|Secondary|Serum Anti-Cixutumumab Antibody Assessment||18 months|Zero participants were analyzed due to no data collection due to low number of clinical responses observed.||||||
1213834|NCT00781911|Secondary|PK: Volume at Steady State (Vss) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1213835|NCT00781911|Secondary|PK: Clearance (CL) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1213836|NCT00781911|Secondary|PK: Area Under Concentration (AUCinf) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1213837|NCT00781911|Secondary|PK: Half-life (t 1/2) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1213838|NCT00781911|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1213839|NCT00781911|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)|Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|18 months|All participants who had received at least one dose of study drug.|||Participants|||Count of Participants
1213840|NCT00781911|Secondary|Percentage of Participants With a Biochemical Response Rate|Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease.|From Start of Treatment Up to 18 Months|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline Chromogranin A and Gastrin data.|||percentage of participants||95% Confidence Interval|Number
1214048|NCT00779142|Primary|30% Decrease in One Subfield Thickness on Optical Coherence Tomography (OCT) 4 Weeks After the Last Intraocular Injection||4 weeks||||participants|||Number
1213841|NCT00781911|Secondary|Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)|Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.|From Start of Treatment Baseline to Disease Progression (Up to 18 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1213842|NCT00781911|Primary|Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months|Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.|From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)|All participants who received at least one dose of study drug. Participants censored in the carcinoid tumor arm were 8 and in the islet cell carcinoma arm were 4.|||percentage of participants||95% Confidence Interval|Number
1213843|NCT00781898|Primary|Relapse|A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.|6 months||||Participants|||Count of Participants
1213844|NCT00781859|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
1213845|NCT00781859|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.|The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.|Day 28|Intention-To-Treat (ITT), Last Observation Carried forward (LOCF)|||percentage of participants|||Number
1213846|NCT00781768|Primary|Complete Response Rates Among Standard of Care and Combination Therapy Groups.|Comparison of complete response (CR) rates between patients receiving ondansetron and dexamethasone and those receiving ondansetron and dexamethasone plus NK-1 antagonist, aprepitant. CR is defined as no emesis and with normal oral intake. Disease response not applicable.|14 days|179 patients receiving autologous and allogeneic hematopoietic stem cell transplants.|||Participants|||Count of Participants
1213847|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 2|A total of 57 participants completed the month 2 visit. The 15 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
1213848|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 1|A total of 60 participants completed the month 1 visit. The 12 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
1213849|NCT00781599|Secondary|Cotinine Verified 7 Day Point Prevalence Smoking Abstinence|Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence.|Month 3|A total of 61 participants completed the final month 3 visit. The 11 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
1213850|NCT00781599|Primary|Percent Compliance With Chantix|Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.|Months 1, 2, 3|Number of participants determined by total number of enrolled participants. For reporting purposes, those participants that did not show up for a visit were treated as smokers.|||Percentage of Participants||Standard Deviation|Mean
1213851|NCT00781508|Secondary|The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg.|A standardized course was used to determine the distance walked (meters) during a 6 min walk supervised by a nurse trained in performance of the test.|Measured 1 hr after oral administration of sildenafil 50 mg||||meters||Standard Deviation|Mean
1213852|NCT00781508|Primary|Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil|Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e|Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil|All patients (10) that completed the protocol were analyzed.|||E/e' ratio||Standard Deviation|Mean
1213853|NCT00781456|Secondary|Mean Number of Days of Bleeding or Spotting|Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.|91-day treatment period|Safety population with available data|||days||Standard Deviation|Mean
1214104|NCT00778648|Secondary|Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs||Baseline, months 2,4,6,8.|||||||
1213854|NCT00781456|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.~The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.~Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.~A serious adverse event (SAE) is one that met any one of the following criteria:~Fatal or life threatening~Requires or prolongs in patient hospitalization~Results in persistent or significant disability/incapacity~Congenital anomaly / birth defect~Important medical event."|Up to 15 weeks|Safety population, consisting of all participants who received at least one dose of study drug.|||participants|||Number
1213855|NCT00781456|Secondary|Change From Baseline in Headache Impact Test|"The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.~HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.~There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated."|Baseline and Week 15|Analysis was not performed due to an error in the administration of the test.||||||
1213856|NCT00781456|Secondary|Change From Baseline in Migraine Disability Assessment|"The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.~The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).~The MIDAS score is classified into four grades of severity:~0 to 5: MIDAS Grade I, Little or no disability~6 to 10: MIDAS Grade II, Mild disability~11 to 20: MIDAS Grade III, Moderate disability~21+: MIDAS Grade IV, Severe disability"|Baseline and Week 15|Intent-to-treat population with available data.|||units on a scale||Standard Deviation|Mean
1213857|NCT00781456|Secondary|Percentage of Participants Who Required Rescue Medications During the Study Period|Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.|Baseline, Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.|||percentage of participants|||Number
1213858|NCT00781456|Secondary|Change From Baseline in Average Migraine Severity|"Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.~Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity."|Baseline and Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.|||units on a scale||Standard Error|Least Squares Mean
1213859|NCT00781456|Secondary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months|The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.|Baseline, Month1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time point.|||percentage of participants|||Number
1213860|NCT00781456|Primary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period|The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.|Baseline (25-35 days before Day 1) and Days 1-91|Intent-to-treat population|||percentage of participants|||Number
1213861|NCT00781391|Secondary|Adjudicated Bleeding Events|"Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.~Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements."|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|Safety-analysis set, on-treatment period|||number of participants with event|||Number
1213862|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality|Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
1213883|NCT00780741|Secondary|Proportion of Participants With Office Probing Success 6 Months After Randomization|The proportion of immediate office group participants whose office probing was successful when assessed 6 months after randomization. Office probing success was defined as absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) 6 months after randomization and no reoperation.|Randomization to 6 months|Participants randomized to immediate office probing who underwent office probing.|||proportion with treatment success||95% Confidence Interval|Number
1213863|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding|Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
1213864|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality|Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit..|||number of participants with event|||Number
1213865|NCT00781391|Primary|Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).|Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
1213866|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (per Protocol) Analysis set; which included all randomized subjects who received 1 or more dose of study drug for the overall study period (first dose to end of study) and did not have any major protocol violations. The time period included from the reference date (initial dose of study drug date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
1213867|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (Per Protocol) Analysis set; which included all randomized subjects who received at least 1 dose of randomized study drug and did not have any major protocol violations. The time period included the time the subject was taking study drug and up to 3 days after their last dose (On Treatment Period).|||number of participants with event|||Number
1213868|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time frame included overall study period (first dose to end of study).|||Number of participants with event|||Number
1213869|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time period included the subject was taking study drug and up to 3 days after their last dose (On-Treatment ).|||number of participants with event|||Number
1213870|NCT00781365|Primary|Mean Diastolic Blood Pressure|Mean diastolic blood pressure at baseline and 4 time points|Baseline, 6 months, 12 months, 18 months, 54 months||||mm Hg||95% Confidence Interval|Mean
1213871|NCT00781365|Primary|Mean Systolic Blood Pressure|Systolic blood pressure at baseline and 4 time points|Baseline, 6 months, 12 months, 18 months, 54 months||||mmHg||95% Confidence Interval|Mean
1213872|NCT00781365|Primary|Blood Pressure Control|Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)|Baseline, 6 months, 12 months, 18 months||||percentage of participants||95% Confidence Interval|Number
1213873|NCT00781326|Primary|Hamilton Depression Rating Scale (24 Item) [Phase I Primary Outcome]|Hamilton Depression Rating Scale (24 item) measures symptoms of major depression. We report total score which is the sum of all items. Total score range is 0 to 76 with higher scores indicating more severe depression. We reports scores at end of Phase I for subjects completing the phase.|End of Phase I (at 24 weeks)||||units on a scale||Standard Deviation|Mean
1213874|NCT00781274|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1213884|NCT00780741|Secondary|Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon unmasked examination 6 months after randomization. Participants who were operated before the 6-month visit were considered treatment failures.|Randomization to 6 months|All participants who had unilateral nasolacrimal duct obstruction at baseline, who were randomized to the deferred facility probing group, and who completed the 6-month visit (timed from randomization). The analysis followed the intent to treat principle.|||proportion of participants||95% Confidence Interval|Number
1214105|NCT00778648|Primary|Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.||within 6 months (after 2 months run-in period)||||Number of days||95% Confidence Interval|Mean
1213875|NCT00781079|Secondary|Quality of Life Interview, Brief Version|Subjective ratings of overall quality of life and the quality of social relationships, daily life, and family interactions was assessed using a combination of selected scales from the Quality of Life Instrument-Brief Version (QOLI), which been used extensively with a wide range of populations including those who are homeless, have a dual diagnosis, and are ethnic minorities. Because of low internal consistencies of subscales in our sample, a factor analysis was conducted which indicated that a larger scale that included the items from the overall quality of life, social relationships, daily life, and family interactions scales would be more reliable (all items averaged together). The score ranges from 1 to 5, with 1 meaning more quality of life.|immediately before the intervention (BL), and 12 months post intervention (Post).|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
1213876|NCT00781079|Secondary|Illness Management and Recovery Scale: Client Self-Rating|The Illness Management and Recovery Scale (IMR) has 15 items (rated on 5-point behaviorally anchored scales) that assess progress toward goals, knowledge about mental illness, involvement with significant others and self-help, time in structured roles, impairment in functioning, symptom distress and coping, relapse prevention and hospitalizations, use of medications, and alcohol and drug use. A total IMR score is made of the mean of the items and has demonstrated good internal consistency, stability (test-retest after two weeks), and convergent validity, correlating with the Recovery Assessment Scale and the Colorado Symptom Index. The total score is reported on the scale of 1 to 5 with higher scores mean better recovery.|12 months prior to the intervention (BL1), immediately before the intervention (BL2), and 12 months post intervention (Post).|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
1213877|NCT00781079|Secondary|Recovery Self-Assessment: Person in Recovery Version|Perceptions of the recovery orientation of the program were assessed with the Recovery Self-Assessment (RSA), a 36 item survey that assesses domains of recovery-orientated practice (e.g., focus on life goals, involvement of patients in their own care). The RSA has high internal consistency and is thought to represent a more recovery-oriented or recovery-supportive environment. Each item ranges from 1 to 5. The total score (all 36 items averaged together) also is reported on that scale, with higher meaning more recovery.|immediately before the intervention (BL), and 12 months post intervention (Post)|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
1213878|NCT00781079|Secondary|Patient Activation Measure|The mental health version of the Patient Activation Measure (PAM) is a single 13-item scale designed to assess patient’s knowledge, skill, and confidence in health self-management. Respondents endorse items (e.g., “I know what each of my prescribed medications do”) on a scale from 1 (“disagree strongly”) to 4 (“agree strongly”). Raw scores are converted using the established methodology for the PAM to an activation score from 0 (lowest)-100 (highest). Identifying levels of activation is based on whether an activation score falls within a previously determined range of scores. Level 1, the lowest level of activation, includes activation scores of 47 or lower; Level 2 includes scores of 47.1 to 55.1; Level 3 includes scores of 55.2 to 67.0; and Level 4 (the highest activation level) includes scores of 67.1 or above. This version has similar psychometric properties as the original 13-item PAM and correlates with related constructs in other samples of people with SMI.|immediately before the intervention (BL), and 12 months post intervention (Post).|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
1213879|NCT00781079|Secondary|Mental Health Recovery Measure (MHRM)|The Mental Health Recovery Measure (MHRM) is a 30-item, 5-point behaviorally-anchored self-report measure based upon recovery experiences of persons with psychiatric disabilities. The MHRM total score has good validity, correlating strongly with the Empowerment Scale and Community Living Skills Scales, yet assessing unique aspects of recovery. Range of total score is 0 to 144, with higher scores meaning better recovery.|immediately before the intervention (BL), and 12 months post intervention (Post).|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
1213880|NCT00781079|Primary|BASIS-R|The BASIS-R is a 24 item, comprehensive instrument assessing a range of psychiatric symptoms and problems. It is valid and reliable in both inpatient and outpatient settings in populations with SMI. All items have five response options ranging from 0 to 4, with higher scores indicating more problems (range in possible scores is 0 to 96).|immediately before the intervention (BL), and 12 months post intervention (Post).||||units on a scale||Standard Deviation|Mean
1213881|NCT00780962|Primary|Number of Participants With Contrast-induced Nephropathy|Contrast-induced nephropathy was defined as an increase in serum creatinine level of greater than or equal to 0.5 mg/dL or an increase of 25% above baseline. The primary outcome was measured by the change in serum creatinine level from the pre-radiocontrast baseline to the serum creatinine level measured 48 to 72 hours after radiocontrast administration.|48-72 hours|Out of 399 subjects who consented to participate in the study, only 357 (89.4%) had a second blood creatinine levels measurement done between 48 to 72h.|||Participants|||Count of Participants
1213882|NCT00780910|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1213885|NCT00780741|Secondary|Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age|Months of NLDO symptoms between randomization and 18 months of age. When resolution of NLDO occurred without surgery, the time of resolution was estimated as the midpoint between randomization and the first time point at which symptoms/signs were reported as absent (i.e. 3-month phone call, 6-month visit, or 18 months of age visit) without a subsequent report of symptoms/signs. For patients who underwent successful surgery, months of symptoms was estimated as months between randomization and the surgery. Patients who had clinical signs present at the 18 month of age visit were considered to have had symptoms present since randomization.|Randomization to 18 months of age.|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.|||months of symptoms||Full Range|Mean
1213886|NCT00780741|Primary|Cost of Treatment|Total cost of treatment including the cost of an initial office consultation and all surgeries received (i.e. initial surgeries and reoperations) and medications prescribed for NLDO between randomization and the 18 months of age visit. Estimates of treatment costs were obtained primarily from the 2011 Medicare Fee Schedules.|Randomization to 18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.|||US dollars||Full Range|Mean
1213887|NCT00780741|Primary|Proportion of Participants With Treatment Success|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.|18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the primary outcome visit at 18 months of age were analyzed. The analysis followed the intent-to-treat principle.|||proportion of participants|||Number
1213888|NCT00780715|Primary|HbA1c Change|Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)|6 months|Modified Intention to treat|||absolute change in %HbA1c||Standard Deviation|Mean
1213889|NCT00780676|Primary|Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months)|Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.|Tumor status assessed every 8 weeks during therapy, up to 6 months|Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to either group, and only treated participants (30) included in analysis.|||Percentage of Participants|||Number
1213890|NCT00780572|Primary|Time to Intervention Once an ADE Alert Has Fired in CPRS||From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours.||||hours to intervention||Inter-Quartile Range|Median
1213891|NCT00780481|Secondary|Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.||Single Study Day|Data was lost||||||
1213892|NCT00780481|Secondary|Radial Artery Elasticity||Single Study Visit|Data was lost||||||
1213893|NCT00780481|Secondary|Peak FMD||Single Study Day|Data Lost||||||
1213894|NCT00780481|Primary|Peak t-PA Release|tPA Release|Single Study day|Data was lost||||||
1213895|NCT00780455|Secondary|Quality of Life Assessed by Use of Self-questionnaire (SEP-59)|SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213896|NCT00780455|Secondary|Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)|FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213897|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits|"Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213898|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit|Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213899|NCT00780455|Secondary|Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit|The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213900|NCT00780455|Secondary|Covered Distance Gain Between MR2 Visit and MR3 Visit|"Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213901|NCT00780455|Primary|Rhythm Change During 6 Minutes Walking Test||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213902|NCT00780455|Primary|Distance of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213903|NCT00780455|Primary|Time of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213904|NCT00780455|Primary|Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1213905|NCT00780442|Primary|Cocaine Craving Scale|"Scale assess cocaine craving following cocaine cue exposure after two administrations of DCS. Subjects rate craving on a scale from 0-10 with 0 indicating Not at all and 10 indicating Extremely."|Immediately following cue exposure|Cocaine dependent individuals|||Units on a scale||Standard Deviation|Mean
1213906|NCT00780416|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1213907|NCT00780403|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).|||participants|||Number
1213908|NCT00780338|Secondary|Prevention Performance - Total Score (Percent Change)|A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or “components”) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from “highly faithful=7” to “highly divergent=1” from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (“highly faithful=7” to “highly divergent=1” from ideal performance)|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. Percent change was calculated from Pre to Mid, Mid to Post, PRE to POST.|||percent change||Full Range|Mean
1213909|NCT00780338|Secondary|Prevention Capacity - Assets Efficacy (User vs Non-user Analyses)|"The Assets efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing assets activities. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"|||percentage of the highest possible score||Standard Error|Least Squares Mean
1217580|NCT00754559|Secondary|Changes in C-Reactive Protein|CRP is an acute phase inflammatory marker used as a measure of inflammation. A reduction in CRP is considered to be an improvement.|Baseline, Weeks 1, 2 ,4 and 24|ITT Population|||mg/L||Standard Deviation|Mean
1213910|NCT00780338|Primary|Prevention Capacity-Assets Efficacy (Intent to Treat)|Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. Assets efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the Developmental Assets model. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale.|Baseline, mid (1 year), post (2 years)|Despite drop outs, all the data was used.|||percentage of the highest possible score||Standard Deviation|Mean
1213911|NCT00780338|Secondary|Prevention Capacity - Assets Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
1213912|NCT00780338|Primary|Prevention Capacity - ASSETS Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
1213913|NCT00780338|Primary|Prevention Capacity - ASSETS GTO Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
1213914|NCT00780338|Secondary|Prevention Capacity - ASSETS GTO BEHAVIORS (User vs Non-user Analyses)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
1213915|NCT00780338|Secondary|Prevention Capacity - GTO Efficacy (User vs Non-user Analyses)|"The GTO efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"|||percentage of the highest possible score||Standard Error|Least Squares Mean
1213916|NCT00780338|Secondary|Prevention Capacity - GTO Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in GTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
1213917|NCT00780338|Primary|Prevention Capacity - GTO Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
1217581|NCT00754559|Secondary|Changes in Hemoglobin|Hemoglobin levels were determined as a hematology parameter to measure changes in disease related anemia.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.|||g/dL||Standard Deviation|Mean
1213918|NCT00780338|Secondary|Prevention Performance - Total Score (Descriptive Means)|A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or “components”) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from “highly faithful=7” to “highly divergent=1” from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (“highly faithful=7” to “highly divergent=1” from ideal performance)|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. These means are presented at the timepoints in which they were collected.|||units on a scale|Participants|Full Range|Mean
1213919|NCT00780338|Primary|Prevention Capacity-GTO Efficacy (Intent to Treat)|Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. GTO efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale.|Baseline, mid-point (1 year), posttest (2 years)|Despite drop outs, all the data was used.|||percentage of the highest possible score||Standard Deviation|Mean
1213920|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|24 months after surgery||||Percentage of implants|Participants||Number
1213921|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|12 months after surgery||||Percentage of implants|Participants||Number
1213922|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|6 months after surgery||||Percentage of implants|Participants||Number
1213923|NCT00780208|Secondary|Number of Participants With Positive Drug Screen|Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens|8 weeks||||Participants|||Count of Participants
1213924|NCT00780208|Primary|ADHD Symptom Severity|Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).|Baseline, Week 8||||units on a scale||Standard Deviation|Mean
1213925|NCT00780143|Primary|Response Rate|To determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.|Until disease progression or unacceptable toxicity|not enough efficacy data were retrieved||||||
1213926|NCT00780143|Primary|Dose Limiting Toxicity|To determine the dose limiting toxicity (DLT) of Plitidepsin (Aplidin®) when administered daily x 5 days with a fixed dose of Cytarabine for 5 days every four weeks in patients with relapsed/refractory leukemia.|Until disease progression or unacceptable toxicity|The Dose Limiting Toxicity not occurred|||Participants|||Count of Participants
1213927|NCT00780143|Primary|Máximum Tolerate Dose|To determine the maximum tolerated dose (MTD) of Plitidepsin (Aplidin®) when administered daily x 5 days with a fixed dose of Cytarabine for 5 days every four weeks in patients with relapsed/refractory leukemia.|Until disease progression or unacceptable toxicity|The Máximum Tolerate Dose level was not reached||||||
1213928|NCT00780026|Secondary|Incidence of Venous Thrombotic Complications|Number of participants who were diagnosed with portal vein thrombosis post surgery|12 months||||participants|||Number
1213929|NCT00780026|Secondary|Incidence of Biliary Complications|Number of participants who experienced bile leak or biliary Stricture|12 months||||participants|||Number
1213930|NCT00780026|Secondary|Need for Hemodialysis|Number of people who had renal failure in the year following liver transplant and needing hemodialysis to support it;|12 months post surgery||||participants|||Number
1213931|NCT00780026|Secondary|Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU|Requirements for blood transfusion counted as a binary variable yes/no per participant|12 months||||participants|||Number
1213932|NCT00780026|Secondary|Hospital Length of Stay||12 months||||days||Standard Deviation|Mean
1213933|NCT00780026|Primary|One Year Survival Post Transplant||12 months||||participants|||Number
1213934|NCT00780026|Primary|Infection Rates|Number of participants who sustained an infection after surgery|30 days||||participants|||Number
1213935|NCT00779909|Secondary|Urinary Calcium/Creatinine Ratio|Urinary calcium ratios were calculated from urine samples at week 4, 7, and 12. A normal reference interval for the urine calcium (mg/dL):urine creatinine (mg/dL) ratio is <0.14.|week 4, week 7, week 12||||ratio||Standard Deviation|Mean
1213936|NCT00779909|Secondary|Serum Calcium|The serum calcium blood test measures the total calcium in the participants' blood. The normal range for total serum calcium concentration in adults is 8.9-10.2 mg/dL.|week 7, week 12||||mg/dl||Standard Deviation|Mean
1213966|NCT00779766|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|up to Months 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213937|NCT00779909|Secondary|Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12|"GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device.~GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. Concentrations of TNF-alpha, IL-1 beta, IL-2, and IL-12 will be measured and means and SDs will be calculated for each study arm."|week 8 and week 12||||pg/site||Standard Deviation|Mean
1213938|NCT00779909|Secondary|Gingival Crevicular Fluid (GCF) Volume|GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device. GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above.|week 8 and week 12||||ul||Standard Deviation|Mean
1213939|NCT00779909|Secondary|Maxillary Plaque Index (PI) Score|The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual’s score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
1213940|NCT00779909|Secondary|Mandibular Plaque Index (PI) Score|The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual’s score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
1213941|NCT00779909|Primary|Maxillary Modified Gingival Index (MGI) Score|The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
1213942|NCT00779909|Primary|Mandibular Modified Gingival Index (MGI) Score|The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
1213943|NCT00779909|Primary|Proportion of Sites That Bleed on Probing|Assessment of the bleeding index will be performed on oral and buccal sites. The periodontal probe will be moved gently across the marginal gingiva of all teeth of a quadrant. After 30 seconds, absence or presence of bleeding will be scored. The number of bleeding sites is used to calculate the gingival bleeding score.|end of 4 week experimental gingivitis phase|Data for this outcome measure was not collected on any of the participants as it was overlooked and failure to collect these data did not come to the attention of the PI until after all follow-ups were completed.||||||
1213944|NCT00779857|Primary|Percent of Patients With Complete Occlusion of the Left Atrial Appendage.|The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.|3 Months Post Procedure|The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.|||percentage of subjects||95% Confidence Interval|Number
1213945|NCT00779857|Primary|Rate of Device Related Serious Adverse Events|The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.|Discharge/30 days Post Procedure|The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.|||Number of participants||95% Confidence Interval|Number
1213946|NCT00779779|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Throughout the study period (Day 0 to Month 3 or 4)|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1213947|NCT00779779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1213948|NCT00779779|Secondary|Number of Subjects Reporting Each Type of Solicited General Symptoms|Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.|During the 8-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1213949|NCT00779779|Primary|"Number of Subjects With at Least One >= Grade 2 Fever, Vomiting or Diarrhoea"|"Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.~Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.~Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day."|During the 8-day solicited follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1213950|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213951|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213952|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213953|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes|"Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth congenital anomaly, Lost to follow up, Molar pregnancy and Pregnancy ongoing.~For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA)."|up to Months 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213954|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213955|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1214027|NCT00779467|Secondary|Shivering|maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably|until delivery||||units on a scale||Standard Deviation|Mean
1213956|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213957|NCT00779766|Secondary|Number (%) of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213958|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213959|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline.|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213960|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213961|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213962|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213963|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213964|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213965|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213967|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity"|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213968|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity.|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213969|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = prevented normal activity Grade 3 urticaria = distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213970|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling = swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1213971|NCT00779766|Secondary|Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status|"Titers were expressed as geometric mean titers calculated on all subjects HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL) at Months 0, 7, 12 and 24 and greater than or equal to 19 ELISA units per millilitre (EL.U/mL) at Months 36, 48 and 72.~HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL) at Month 0, 7, 12 and 24 and greater than or equal to 18 ELISA units per millilitre (EL.U/mL) at Months 36, 48 and 72..~Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above the assay cut-off value prior to vaccination."|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1213972|NCT00779766|Secondary|Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and greater than or equal to 18 ELISA units per millilitre (EL.U/mL) at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL and 18 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subjects|||Number
1213973|NCT00779766|Secondary|Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and greater than or equal to 19 ELISA units per millilitre (EL.U/mL) at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subjects|||Number
1213974|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type|"CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1214028|NCT00779467|Secondary|Sedation|average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy|until delivery||||units on a scale||Standard Deviation|Mean
1213975|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type|"CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213976|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection|CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213977|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection|"CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.~DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213978|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213979|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~US)."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213980|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24,48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213981|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213982|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213983|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18|"Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months.~Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA).~Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213984|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18|"Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months.~Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213985|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18|"HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered.~DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)~Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24,48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213986|NCT00779766|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18|"CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.~Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at Months 0 and 6 and seronegative at Month 0 or on subjects DNA- at Months 0 and 6, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1213987|NCT00779701|Primary|Time to Achieve Glycemic Control||Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.||||Minutes||Standard Deviation|Mean
1213988|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline..|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1213989|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1214029|NCT00779467|Secondary|Nausea|average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable|until delivery||||units on a scale||Standard Deviation|Mean
1214030|NCT00779467|Primary|Amount of Drug Consumed Per Hour in Each Group(Arm)|Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)|until delivery|median hourly total bupivacaine consumption in each group, in ml/hr|||milliliters per hour||Inter-Quartile Range|Median
1213990|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1213991|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1213992|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1213993|NCT00779675|Secondary|Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase with at least one PASI evaluation during the extended treatment phase.|||Participants|||Number
1213994|NCT00779675|Secondary|Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at each time point.|||Participants|||Number
1213995|NCT00779675|Secondary|Change From Baseline in Mean Dermatology Life Quality Index (DLQI)|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Baseline, Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at baseline and at each time point.|||Score on a Scale||Standard Error|Mean
1214031|NCT00779402|Primary|Number of Subjects That Met Biochemical Failure Status|time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.|Every 3 months post-infusion||||Participants|||Count of Participants
1214032|NCT00779402|Primary|Time to Biochemical Failure Cumulative Incidence Percentile|Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL|Every 3 months post-infusion|Number of subjects that met biochemical failure criteria.|||Months||95% Confidence Interval|Median
1213996|NCT00779675|Secondary|Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase|PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase and had a PASI-75 response at Week 50 with at least one PASI evaluation during the extended treatment phase.|||Participants|||Number
1213997|NCT00779675|Secondary|Change From Baseline in Mean PASI Score|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score.|Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98|The population consists of all participants with a baseline PASI score and a subsequent score at Week 14, 30, 50, 62, 78,and 98.|||Score on a Scale||95% Confidence Interval|Mean
1213998|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively.|Week 98|The population includes all participants that achieved PASI-50 response at Week 50 and entered the extended treatment phase.|||Participants|||Number
1213999|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period|Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline.|Week 98|The population consists of all participants that achieved PASI-90 response at Week 50 and entered the extended treatment phase.|||Participants|||Number
1214000|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline.|Week 50|The population includes all participants that achieved a PASI-50 response at treatment Week 14.|||Participants|||Number
1214001|NCT00779675|Secondary|Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline.|Week 50|The population consists of all participants that achieved PASI-75 response by treatment Week 14.|||Participants|||Number
1214002|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline.|Week 50|The population consists of all participants that achieved a PASI-90 response at treatment Week 14.|||Participants|||Number
1214003|NCT00779675|Primary|Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1214004|NCT00779584|Secondary|MK-8776 Terminal Phase Half-Life (t1/2)|The t1/2 of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||hr||Standard Deviation|Mean
1214005|NCT00779584|Secondary|Time of MK-8776 Cmax (Tmax)|The time of Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||hr||Standard Deviation|Mean
1214006|NCT00779584|Secondary|MK-8776 Area Under the Curve of the Plasma Concentration Versus Time From Time Zero to the Time of the Last Analytically Quantifiable Concentration (AUC0-last)|AUC0-last was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. AUC0-last was calculated by the linear trapezoidal method.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||ng*hr/mL||Standard Deviation|Mean
1214007|NCT00779584|Secondary|MK-8776 Maximum Plasma Concentration (Cmax)|The Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||ng/mL||Standard Deviation|Mean
1214008|NCT00779584|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximatey 66 weeks|The population consisted of all participants who received at least one dose of MK-8776.|||Participants|||Number
1214009|NCT00779584|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who experienced an AE is presented.|Up to approximately 72 weeks (Up to approximately 6 weeks after last dose of study treatment)|The population consisted of all participants who received at least one dose of MK-8776.|||Participants|||Number
1214033|NCT00779311|Secondary|Determination of Quality of Life (QoL) as Indicated by Patient Care Monitor (PCM) Data Among Patients on This Regimen|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The frequency of patient reported severe (rated as >=7) symptoms reported from the set of symptoms assessed by the PCM.|The PCM questionnaire was administered on day 1 of each cycle (approximately every 2 weeks) during study treatment.|The number of patients out of the total sample of 8 patients who reported severe (rated as >=7) symptoms as assessed by the PCM. Symptoms with 0 patients reporting severe symptoms have been omitted.|||Participants|||Number
1214010|NCT00779584|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 0 and Cycle 1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v 3.0)|During Cycle 0, a DLT was defined as: CTCAE v 3.0 Grade 3 neutropenia or thrombocytopenia lasting ≥3 days; any CTCAE v 3.0 Grade 4 neutropenia or thrombocytopenia; neutropenic fever; any CTCAE v. 3.0 ≥ Grade 3 QT interval corrected by Fridericia (QTcF) prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s); delay in Cycle 1 Day 1 beyond 3 weeks due to continuing toxicity. During Cycle 1, a DLT was defined as: CTCAE v 3.0 Grade 4 neutropenia that persists for ≥7 days; neutropenic fever; CTCAE v 3.0 Grade 4 thrombocytopenia; CTCAE v 3.0 ≥ Grade 3 thrombocytopenia with bleeding; any CTCAE v 3.0 QTc ≥ Grade 3 QTcF prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s).|Through Cycle 0 and Cycle 1 (Up to 42 days)|The population consisted of all participants who were evaluable for DLT assessment (i.e., completed Cycle 0 and Cycle 1).|||Participants|||Number
1214011|NCT00779558|Secondary|Need for Antibiotics||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||participants|||Number
1214012|NCT00779558|Secondary|Cardiac ICU Length of Stay||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||days||Standard Deviation|Mean
1214013|NCT00779558|Secondary|Days to Extubation||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||days||Standard Deviation|Mean
1214014|NCT00779558|Secondary|Total PRBCs Transfused||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||mL/kg||Standard Deviation|Mean
1214015|NCT00779558|Primary|Thrombosis|Echocardiographic evidence of thrombosis while on study drug|While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days||||participants|||Number
1214016|NCT00779506|Secondary|Global Assessment of Functioning (GAF) Score|To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1214017|NCT00779506|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1214018|NCT00779506|Secondary|Clinical Global Impression (CGI) Score|The Clinical Global Impression – Severity (CGI-S) and – illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient’s current clinical state. The CGI-I is scored to rate the patient’s change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1214019|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score|To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1214020|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Score|To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1214021|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Positive Score|To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1214022|NCT00779506|Primary|The Change in Positive and Negative Syndrome Scale(PANSS)Total Score|"PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 – 210.~Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method"|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1214023|NCT00779467|Secondary|Cesarean Delivery|percentage of subjects in each group requiring a ceserean delivery|occurence||||percentage of subjects in each group|||Number
1214024|NCT00779467|Secondary|Patient Satisfaction Scores|maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia|within 24 hours post delivery||||units on a scale||Inter-Quartile Range|Median
1214025|NCT00779467|Secondary|Bromage Score|the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)|until delivery|Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)|||units on a scale||Standard Deviation|Mean
1214026|NCT00779467|Secondary|Pruritus|the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.|until delivery|the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.|||units on a scale||Standard Deviation|Mean
1214035|NCT00779311|Primary|Determination of the Maximum Tolerated Dose (MTD) of Sorafenib When Given in Combination With mFOLFOX6 and Bevacizumab|The MTD of sorafenib was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first 2 cycles of treatment (i.e., the first 4 weeks of treatment since cycle length is 2 weeks)|3 patients (pts) were enrolled at DL 1 with 1/3 experiencing DLT, so 3 additional pts were enrolled at DL 1. 2 of those additional pts were not evaluable for DLT assessment and were replaced. 2 more pts were enrolled for a total of 8 pts, and 1 of these pts experienced a DLT. All of the 8 pts enrolled received sorafenib at DL 1.|||mg every other day|||Number
1214036|NCT00779285|Primary|Cardiac Events|A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).|Every 4 weeks during 6 cycles.||||Cardiac Events|||Number
1214037|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Theophylline Co-administered With Quinine, Study Day 12.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours post-dose on Day 12||||msec|||Number
1214038|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Quinine Study Day 11.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours after the morning dose on Day 11||||msec|||Number
1214039|NCT00779259|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug-hr/mL||Standard Deviation|Mean
1214040|NCT00779259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug-hr/mL||Standard Deviation|Mean
1214041|NCT00779259|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug/mL||Standard Deviation|Mean
1214042|NCT00779246|Secondary|Vancomycin Resistant Enterococcal Infection or Colonization||During ICU stay|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||Participants|||Count of Participants
1214043|NCT00779246|Secondary|Number of Participants With Central Line Associated Bloodstream Infection||During ICU stay up to six months|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||participants|||Number
1214044|NCT00779246|Primary|Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection|Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).|During ICU stay|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||participants|||Number
1214045|NCT00779155|Primary|"Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects on State."|The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.|Baseline and 8 weeks|Analysis was by intention to treat and all enrolled subjects completed the entire protocol.|||scores on a scale||Standard Deviation|Mean
1214046|NCT00779142|Secondary|Secondary Would be Significant Clinical Improvement (Judged at the Slit Lamp Exam Using a 90D Lens) in Macular Edema at the End of One Month After the Last Intraocular Injection.||1 month||||Participants|||Count of Participants
1214049|NCT00779116|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).|||Participants|||Number
1214050|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|End of Study treatment (Hour 72)|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1214051|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 48|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1214052|NCT00779038|Secondary|Number of Participants With Physician Global Assessment of Method of Pain Control|"The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1214053|NCT00779038|Secondary|Number of Participants With Nurse Global Assessment of Method of Pain Control|"The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1214054|NCT00779038|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: “Overall, would you rate this method of pain control as being poor, fair, good, or excellent?”|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1214055|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24|Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 24|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1214056|NCT00779025|Secondary|Number of Sensations Experienced by Female Subjects - Overall|Number of sensations experienced by female subjects, based on two applications of the product for each subject.|1 Week|Intention to Treat|||Sensations|Participants||Number
1214057|NCT00779025|Secondary|Number of Sensations Experienced by Male Subjects - Overall|Number of sensations experienced by male subjects, based on two applications of the investigational product.|1 Week||||Sensations|Participants||Number
1214058|NCT00779025|Primary|Number of Participants Showing Change From Baseline in Irritation Scores|Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions|1 week|Analysis was per Intention to Treat (ITT)|||Participants|||Number
1214059|NCT00778999|Secondary|Number of Good Quality Embryos|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1214060|NCT00778999|Secondary|Number of Fertilized (2PN) Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1214061|NCT00778999|Secondary|Number of Follicles on Day of hCG|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1214062|NCT00778999|Secondary|Number of Follicles on Stimulation Day 8|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1214063|NCT00778999|Secondary|Number of Mature Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1214064|NCT00778999|Primary|Total Number of Oocytes|The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response|12 weeks|Intent-to-treat, defined as all randomized subjects who received recombinant follicle stimulating hormone|||Number of oocytes||Standard Deviation|Mean
1214065|NCT00778921|Secondary|Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)||12 weeks|||||||
1214066|NCT00778921|Secondary|Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group||8 weeks|Analysis: Intention to Treat (ITT) Imputation Technique: Last Observation Carried Forward (LOCF)|||Participants|||Number
1214067|NCT00778921|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study||Baseline and Week 8|full analysis set|||mm Hg||Standard Error|Least Squares Mean
1214068|NCT00778921|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study||Baseline and Week 8|full analysis set|||mm Hg||Standard Error|Least Squares Mean
1214369|NCT00775645|Other Pre-specified|Association Between Genetic Markers Responsible for Taxane Metabolism and Clearance and the Degree of Neuropathy|Explore the relationship between genetic markers responsible for taxane metabolism and clearance (e.g., CYP2C8, CYP3A4, CYP3A5, GSTM1, and GSTP1) and the degree of neuropathy in these patients.|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
1214069|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214070|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214071|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214072|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214073|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|"Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214074|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|"Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1214075|NCT00778895|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1214076|NCT00778895|Secondary|Seroconversion Factor for HI Antibodies|"The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).~The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1214106|NCT00778622|Other Pre-specified|Number of Participants Who Had a Normal Electrocardiogram (ECG) at Baseline and an ECG at Week 16 (or Termination Visit) Which Was Considered to be Abnormal With Clinical Significance - Safety Population|Baseline was defined as ECG obtained at the screening visit. A judgment of clinical significance was at the discretion of the investigator. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|number of participants with a normal ECG at baseline for normal weight, overweight, and obese arms were 71, 62, 65, respectively.|||participants|||Number
1214077|NCT00778895|Secondary|Number of Subjects Seroprotected Against HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.~The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1214078|NCT00778895|Secondary|Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1214079|NCT00778895|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1214080|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214081|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214082|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214083|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214084|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1214107|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population|Baseline was defined as the value obtained at screening or value obtained on Day 1 before treatment. Diastolic and systolic blood pressure was measured in millimeters of mercury (mm Hg). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16||||mm Hg||Standard Deviation|Mean
1220408|NCT00732940|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
1214085|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1214086|NCT00778895|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1214087|NCT00778869|Primary|Number of Genes Which Were Differentially Expressed|Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.|14 weeks||||Number of genes|||Number
1214088|NCT00778830|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|Safety population consisted of all the enrolled subjects who received at least one dose of study treatment.|||Subjects|||Number
1214089|NCT00778830|Secondary|Overall Survival (OS) Time|OS time was defined as the time from first administration of study drug until date of death, assessed up to 5 years. OS time was censored if the subject was found to be alive on the last date of the assessment.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1214090|NCT00778830|Secondary|Progression-Free Survival (PFS) Time|PFS time was defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 90 days of the last tumor assessment or first study drug dose whichever occurred.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1214091|NCT00778830|Primary|Percentage of Subjects With Best Overall Confirmed Response Rate (BORR)|Response rate was defined as the percentage of subjects with BORR (confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012)|Intention-to-treat (ITT) population consisted of all the enrolled subjects who received at least one dose of study treatment.|||Percentage of subjects|||Number
1214092|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 48 Weeks|Total number of patients whose tumor size at 48 weeks was smaller than their tumor size recorded at baseline (by any amount).|48 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
1214093|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 18 Weeks|Total number of patients whose tumor size at 18 weeks was smaller than their tumor size recorded at baseline (by any amount).|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
1214094|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks|Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount).|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
1214095|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks|Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount).|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
1214182|NCT00777790|Primary|Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.|Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.|Day 0 and 8 and 28 days post-vaccination|GMT results were on the per-protocol population for immunogenicity.|||Titer||95% Confidence Interval|Geometric Mean
1214096|NCT00778817|Secondary|Response at 48 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|48 weeks||||percentage of participants|||Number
1214097|NCT00778817|Secondary|Response at 18 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|18 weeks||||percentage of participants|||Number
1214098|NCT00778817|Secondary|Response at 12 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|12 weeks||||percentage of participants|||Number
1214099|NCT00778817|Secondary|Response at 6 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|6 weeks||||percentage of participants|||Number
1214100|NCT00778817|Secondary|Best Response Rates|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|Up to 6 months||||percentage of participants|||Number
1214101|NCT00778817|Primary|Progression-free Survival Rate at 18 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
1214102|NCT00778817|Primary|Progression-free Survival Rate at 12 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
1214103|NCT00778817|Primary|Progression-free Survival Rate at 6 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
1214108|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population|Baseline was defined as ECG obtained at the screening visit. ECG was 12-lead. Heart rate (HR) was measured in beats per minute (beats/min). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Safety population included 125, 122, 124 participants in each arm, respectively. Participants missing from analysis for change at Week 16 for Heart Rate were 17, 18, 20 participants in the normal, overweight, obese arms, respectively.|||beats/min||Standard Deviation|Mean
1214109|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population|Urinalysis included pH and specific gravity. Baseline defined as values obtained at screening visit. Clinically significant: outside the reference range (low/high)and judged to be significant by the investigator: Specific gravity 1.003 - 1.035; ph 5 - 8. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16||||participants|||Number
1214110|NCT00778622|Other Pre-specified|Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population|Baseline defined as value obtained either in screening visit or last value obtained before glucophage XR treatment given on Day 1. Serum chemistries evaluating kidney or liver function: blood urea nitrogen(BUN), serum creatinine (SCr), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin (BR), uric acid (UA). Abnormal increase in kidney and liver function tests defined as 1.25 - less than, equal to (<=)2.6 times (x) upper limit of normal (ULN)in ALT, AST, total BR, UA; abnormal increase defined as 1.25 to <= 5.1 x ULN in BUN. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Number of participants (normal, overweight, obese, respectively) who were missing values and were not included in the Week 16 analysis for the following serum chemistry tests: ALT = 14, 11, 13; AST = 14, 11, 13; total BR = 14, 11, 13; creatinine = 14, 12, 13; BUN = 14, 12, 13; UA = 14, 12, 13.|||participants|||Number
1214111|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population|Hematology profile = hematocrit, hemoglobin, red blood cell count (RBC), white blood cell count(WBC), lymphocytes, monocytes, basophils, eosinophils, neutrophils, platelet count. Baseline: value obtained at screening or last value obtained before treatment. LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; RBC (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; WBC (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Week 16|Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|||participants|||Number
1214112|NCT00778622|Other Pre-specified|Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population|Day 1 was first day of treatment. Lactic acidosis defined as elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and increased lactate/pyruvate ratio. Hypoglycemia (low levels of blood glucose) was reported as an adverse event. Safety population included participants who had enrolled in the study and took at least 1 dose of glucophage extended release (glucophage XR). If a subject experienced more than one adverse event, the subject was counted once at the highest severity.|Day 1 to Week 16|All participants enrolled in the study and who received at least 1 dose of Glucophage XR.|||participants|||Number
1214113|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 78, 70, and 72 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mg/L||95% Confidence Interval|Mean
1214114|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL.|Baseline to Week 16|Full Analysis Set (FAS) population = 111, 111, 112 in normal, overweight, obese participants respectively. For this outcome measure, 84, 79, and 75 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||U/mL||95% Confidence Interval|Mean
1214115|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 102, 95, and 85 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mg/L||95% Confidence Interval|Mean
1214116|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 4, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1214370|NCT00775645|Other Pre-specified|Association Between Nerve Growth Factor Levels and the Degree of Neuropathy and Functional Status|Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
1214117|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 2, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1214118|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set|Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 9 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1214119|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set|For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1214120|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set|Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) included enrolled participants,who took at least 1 dose of drug and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 1, and 1 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1214121|NCT00778622|Primary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)|Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.|Baseline to Week 16|Full Analysis Set included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. Baseline data was not carried forward or averaged with on-treatment data to impute missing values for the LOCF data set.|||percentage of hemoglobin||95% Confidence Interval|Mean
1214122|NCT00778375|Secondary|Overall Response Rate (CR, CRp/CRi and PR)|IWG Response criteria (2003): Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L or Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial Remission (PR): Blood count recovery as for CR, but with both a decrease in marrow blasts of at least 50% and not more than 6 to 25% abnormal cells in the marrow. Participants not achieving a complete remission following first induction course, can receive a second induction course at least 28 days following first to optimize response if possible.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|Of 119 enrolled, one participant was not evaluable for response.|||Percentage of Participants|||Number
1214123|NCT00778375|Secondary|Event Free Survival (EFS)|EFS is defined as length of time after primary treatment for a cancer ends that the participant remains free of certain complications or events that the treatment was intended to prevent or delay, for example but not exclusive of hematologic and non-hematologic toxicities, cumulative toxicities with consolidation courses, or emergence of resistance to the chemotherapy component of treatment.|Follow up up to 5 years/60 months.|Of 119 enrolled, one participant was not evaluable for response.|||Months||Full Range|Median
1214124|NCT00778375|Primary|Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|One participant of 119 treated was not evaluable for response. Twenty-two participants required re-induction.|||Participants|||Number
1214125|NCT00778375|Primary|Median Overall Survival (OS)|Overall survival (OS): Time from date of treatment start until date of death due to any cause.|Evaluated from treatment date until date of death, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.|||Months||Full Range|Median
1214126|NCT00778375|Primary|Complete Remission (CR) Rate for First 60 Participants|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days|The outcome population consisted of first sixty participants enrolled between October 2008 and January 2010, of whom 59 were evaluable for response.|||Percentage of Participants|||Number
1214127|NCT00778375|Primary|Disease-free (DFS) or Relapse-free Survival (RFS) Time|Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.|Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.|||Months||Full Range|Median
1214128|NCT00778336|Secondary|Description of Treatments by Thrombotic Condition|The # of patients that were exposed to each treatment at least once in the given thrombotic condition.|Index Procedure||||Participants|||Number
1214129|NCT00778336|Secondary|Rethrombosis|The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).|3 Month Follow Up||||Participants|||Number
1214130|NCT00778336|Primary|Change From Baseline to Final Angiographic Results|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,each vessel was assigned a value by the treating physician:~complete occlusion (> 90% occlusion);~substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);~partial occlusion (<50% occlusion AND <3cm in length);~patent (Without visable thrombus or occlusion).~The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value."|Index Procedure ( pre-endovascular treatment and post-endovascular treatment)|Intention to Treat (ITT)|||Occlusion Index||Standard Error|Mean
1214131|NCT00778310|Primary|Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo|Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.|Placebo and Drug day, 1-2 weeks apart|The number who completed both fMRI one week apart (crossover study, scanned twice|||Face-Shape BOLD signal difference||Standard Deviation|Mean
1214132|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline to the time complete milk tolerance was established|Data were not collected and therefore no analyses could be performed.||||||
1214133|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline, Month 12, Month 24, and Month 36|Data were not collected and therefore no analyses could be performed.||||||
1214134|NCT00778258|Secondary|Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk|Participants were grouped based on the food they reacted to, at the baseline Oral Food Challenge (OFC). Group 1= reacted to muffin; Group 2= reacted to pizza; Group 3= reacted to rice pudding; Group 4= reacted to non-baked milk; Group 5= did not react. Groups 2- 4 were randomized to dose escalation or maintenance, and Group 1, and a Control group that chose not to participate in the study, continued to avoid milk. Randomized participants performed an OFC at each visit during which they were given progressively less denatured/ baked milk protein food items until they had an allergic reaction. Participants were considered tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk. Tolerance of non-heated milk was assessed by report among those who continued to avoid milk.|Month 36|Randomized and comparison participants|||percent participants|||Number
1214135|NCT00778258|Secondary|Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. The relationship between serum IgE to betalactoglobulin and casein, and the food level at which the participant reacted, were evaluated at each post randomization OFC visit. It is expected that those who reacted to muffin would have a higher ratio of casein to betalactoglobulin than those who reacted to less heated forms of milk.|Baseline, Month 12, Month 24, Month 36|Intent-to-treat|||Ratio||Inter-Quartile Range|Median
1214136|NCT00778258|Secondary|Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat participants who achieved tolerance|||months||Standard Deviation|Mean
1214137|NCT00778258|Secondary|Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of the number of basophils and T regulatory cells reactive to milk proteins and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat|||cells/µL||Inter-Quartile Range|Median
1214138|NCT00778258|Secondary|Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of IgE to milk proteins and allergic reaction at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat|||kUa/L||Inter-Quartile Range|Median
1214139|NCT00778258|Secondary|Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarkers of basophil reactivity and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Basophils come from blood drawn at baseline. Basophils counts were done using whole blood specimens. Basophil reactivity as measured as maximal degranulation percentage after stimulation with titrated dilutions of milk powder (from 1x103 to 1x10-1 µg/mL total protein) and was correlated to group assignment using Spearman correlation coefficients.|Baseline|Intent-to-treat|||percentage of max basophil degranulation||Inter-Quartile Range|Median
1214140|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any of the food given in the OFC.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat|||percentage of participants|||Number
1214141|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at the specified visit, they did not react to any of the foods given in the OFC.|12 months, 24 months, and 36 months|Randomized intent-to-treat|||percentage of participants|||Number
1214142|NCT00778258|Secondary|Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months|Participants were grouped based on the food they experienced a reaction to at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, performed an OFC where food products containing milk protein denatured through baking were given. Participants were given progressively less denatured milk protein food items until an allergic reaction occurred. A positive progression in tolerance of baked milk was defined as a reaction to a less denatured milk protein food at 12 months than at baseline. Positive progression at 24 months was defined as experiencing a reaction to a less denatured milk protein food at 24 months than at 12 months.|12 months, 24 months|Randomized intent-to-treat|||participants|||Number
1214143|NCT00778258|Primary|Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat|||participants|||Number
1214144|NCT00778167|Primary|Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)|Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.|From time of first dose up to 28 days|Patients were evaluated with history, physical examination, vital signs, and blood tests weekly through cycle 1 and on day 1 of each subsequent cycle. Incidence and severity of AEs were collected at each study visit and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.|||Participants|||Number
1214207|NCT00777205|Primary|Depression Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1214145|NCT00778102|Secondary|Percentage of Participants With Complications Related to Second Resective Surgery|Complications related to the second resective surgery were evaluated using the NCI-CTCAE version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 = resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given AE by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent second resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (Second Surgery Subpopulation): All participants who underwent a second resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.|||percentage of participants|||Number
1214146|NCT00778102|Secondary|Percentage of Participants With Complications Related to First Resective Surgery|Complications related to the first resective surgery were evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 equals (=) resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given adverse event (AE) by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent first resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (First Surgery Subpopulation): All participants who underwent a first resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.|||percentage of participants|||Number
1214147|NCT00778102|Secondary|Time to Response|Time to response according to RECIST version 1.0 was defined as the time from randomization to the date of first documented CR or PR. Participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. For participants who did not complete a confirmatory tumor assessment, time to response was censored at the date of last tumor assessment, or if unavailable, at the date of first dose. Time to response was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||months||95% Confidence Interval|Median
1214148|NCT00778102|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Using RECIST version 1.0, participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. The collective percentage of participants with confirmed best overall response of CR or PR was calculated as [number of participants meeting RECIST criteria for CR or PR divided by the number of participants analyzed] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1214149|NCT00778102|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause. For participants without an event of death, OS was censored at the last-known alive date. OS was estimated by Kaplan-Meier analysis.|Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population|||months||95% Confidence Interval|Median
1214150|NCT00778102|Secondary|Percentage of Participants Who Died||Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population|||percentage of participants|||Number
1214151|NCT00778102|Secondary|Progression-Free Survival (PFS)|PFS was defined, using RECIST version 1.0, as the time from randomization to the date of first documented PD or death from any cause. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. For participants without documented PD or death, PFS was censored at the time of last tumor assessment. PFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||months||95% Confidence Interval|Median
1214152|NCT00778102|Secondary|Percentage of Participants Experiencing Death or Disease Progression|PD was defined, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. The percentage of participants experiencing PD or death was calculated as [number of participants with event divided by the number of participants analyzed] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||percentage of participants|||Number
1214274|NCT00776984|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Score on a scale||Standard Error|Mean
1214153|NCT00778102|Secondary|Relapse-Free Survival (RFS)|RFS was defined as the time from curative resection (complete resection [R0] or microscopic residual tumor [R1]) to the date of first diagnosis of relapse. For participants with curative resection and without relapse, RFS was censored at the last known relapse-free assessment. RFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.|||months||95% Confidence Interval|Median
1214154|NCT00778102|Secondary|Percentage of Participants Experiencing Relapse Following Curative Resection|Among participants with curative resection (complete resection [R0] or microscopic residual tumor [R1]), relapse was defined as the first new occurrence of cancer or death. The percentage of participants who experienced relapse was calculated as [number of participants with a relapse event divided by the number of participants initially classified as R0 or R1 following resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.|||percentage of participants|||Number
1214155|NCT00778102|Secondary|Percentage of Participants With Complete or Major Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, as described previously. The collective percentage of participants assessed as having a complete or major response was calculated as [number of participants with complete or major response divided by the number of participants who completed the assessment] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1214156|NCT00778102|Secondary|Percentage of Participants With Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, where 'Complete response' was considered for those with 0 percent (%) viable tumor cells, 'Major response' for those with 1% to 49% viable tumor cells, 'Minor response' for 50% to 99% viable tumor cells, and 'No response' for 100% viable tumor cells. The response could not be determined in some cases and was documented as 'Unknown.' The percentage of participants within each response category was calculated as [number of participants with a given response divided by the number of participants who completed the assessment] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.|||percentage of participants|||Number
1214157|NCT00778102|Secondary|Time to Resection|Time to resection was defined as the time from randomization to the date of first resective surgery. For participants who did not undergo resective surgery, time to resection was censored at Day 1. Time to resection was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; prior to each cycle, and within 7 days prior to surgery; and at time of surgery)|ITT Population|||months||95% Confidence Interval|Median
1214158|NCT00778102|Primary|Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor|Following resective surgery, participants were evaluated for complete resection (R0) or the presence of microscopic (R1) or macroscopic (R2) residual tumor. The percentage of participants within each residual tumor classification was calculated as [number of participants with R0, R1, and/or R2 divided by the total number of participants] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1214159|NCT00777946|Secondary|Percentage of Participants Achieving a Systolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
1214160|NCT00777946|Secondary|Percentage of Participants Achieving a Diastolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
1214258|NCT00777036|Secondary|Major Cytogenetic Response (MCyR) Rate in Cohort 2|Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 2|||percent of participants||95% Confidence Interval|Number
1214161|NCT00777946|Secondary|Percentage of Participants Achieving Blood Pressure Control|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
1214162|NCT00777946|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|"The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.~Additional information about Adverse Events can be found in the Adverse Event Section."|8 weeks|Safety Population consisted of all randomized participants who received study drug.|||participants|||Number
1214163|NCT00777946|Secondary|Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||mm Hg||Standard Error|Least Squares Mean
1214164|NCT00777946|Primary|Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||mm Hg||Standard Error|Least Squares Mean
1214165|NCT00777855|Secondary|Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin|Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days|||ng/ml||Standard Deviation|Mean
1214166|NCT00777855|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin|Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days|||ng/ml*h||Standard Deviation|Mean
1214167|NCT00777855|Primary|S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours.|Uptake effects on warfarin pharmacokinetics during time period of hepatic organic anion-transporting polypeptide (OATP) inhibition by rifampin. Blood collection 1, 2, 4, 6, 8, and 12 hours after warfarin dosing.|0-12 hours after warfarin dosing|Each of 10 participants received both treatments separated by a minimum of 14 days; treatment sequence was randomly assigned|||ng/ml*h||Standard Deviation|Mean
1214168|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.|||participants|||Number
1214169|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.|||participants|||Number
1214170|NCT00777803|Secondary|Response by Patient's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214171|NCT00777803|Secondary|Responder by Patient's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1217626|NCT00754338|Primary|Comfort|Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1214172|NCT00777803|Secondary|Responder by Patient’s Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214173|NCT00777803|Secondary|Responder by Patient’s Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214174|NCT00777803|Secondary|Responder by Investigator’s Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214175|NCT00777803|Secondary|Responder by Investigator’s Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214176|NCT00777803|Secondary|Responder by Investigator’s Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214177|NCT00777803|Secondary|Responder by Investigator’s Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214178|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214179|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214180|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214181|NCT00777803|Primary|Responder by Independent Rater's Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1214338|NCT00776230|Primary|Primary: 1. Geometric Mean Titers (GMT) at Day 56||56 days post 1st vaccination|Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication|||Geometric Mean Titer - Estimate||95% Confidence Interval|Geometric Mean
1214183|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:100,000 dilutions: n=30; for 1:10,000 dilutions: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
1214184|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:1000 dilutions: n=27; for 1:100 dilutions: n=21; for 1:10 dilutions: n=13. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
1214185|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)|For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient. For healthy volunteer cohort, undiluted: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
1214186|NCT00777764|Primary|Number of Participants by of Adverse Events Following a Skin Test Procedure|"Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours.~Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death."|Up to 7 days following skin testing|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient.|||participants|||Number
1214187|NCT00777634|Primary|Incidence of Diagnosis of Three or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
1214188|NCT00777634|Primary|Incidence of Diagnosis of Two or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
1214189|NCT00777634|Primary|Incidence of Diagnosis of Any Metabolic Syndrome Component|The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
1214190|NCT00777634|Primary|Incidence of Diagnosis of Type 2 Diabetes|The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
1214191|NCT00777634|Primary|Incidence of Diagnosis of Hypertension|The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
1214192|NCT00777634|Primary|Incidence of Diagnosis of Dyslipidemia|The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
1214193|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12|"The ADAS-Cog is a psychometric instrument that evaluates memory, attention,~reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline."|Baseline and 4 weeks, 8 weeks and 12 weeks.|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
1214194|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.|Baseline and 2 weeks, 8 weeks and 12 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
1214371|NCT00775645|Other Pre-specified|Treatment and Concurrent Therapy|total dose of taxane received and treatment delays, compliance with therapy, and use of concurrent medications, dietary supplements (e.g., glutamine), vitamin E, and complementary and alternative medicines|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
1214195|NCT00777608|Primary|Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.|Baseline and 4 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
1214196|NCT00777556|Secondary|Participants Summarized by Repeat Use of Emergency Contraception (EC)|As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.|up to week 8|Participants dispensed the product|||participants|||Number
1214197|NCT00777556|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.|Day 1 to week 8|Safety population of participants who took study drug|||participants|||Number
1214198|NCT00777556|Primary|Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions|The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.|Week 1|Eligible participants who appropriately self-selected and used the product.|||percentage of treated participants||95% Confidence Interval|Number
1214199|NCT00777556|Primary|Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions|The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.|Day 1|Enrolled participants|||percentage of participants||95% Confidence Interval|Number
1214200|NCT00777335|Secondary|Corrected QT Interval Fridericia's Formula (QTcF)|Prolonged QTcF: QTcF >450 msec and increase of baseline on greater than or equal to 60 msec.|Panobinostat intra-venous (i.v.): All cycles pre-dose measurements. For cycles 1 and 2, post-dose measurements as well. / Panobinostat oral: Pre-dose and post-dose measurements for all cycles. Note: each cycle = 3 weeks||||participants|||Number
1214201|NCT00777335|Primary|Overall Response (OR) Rate (as Determined by the Investigator): the Number of Patients Assigned to a Treatment Arm With a Confirmed Best Response of Complete Response(CR) or Partial Response (PR).|"The assessment of OR is based on the response of target lesion, of non-target lesion and on presence of new lesions (RECIST Criteria (V1.0)-assessed by CT scan spiral and bone scan)~CR:Disappearance of all target lesions~PR:>=30% increase in the sum of the longest diameter (SLD),taking as reference the nadir SLD~Progressive Disease (PD):>=20% increase in the SLD, taking as reference the nadir SLD, or the appearance of one or more new lesions~Stable Disease(SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the nadir SLD"|At screening, every 2 cycles (i.e. 6 weeks) during the first 6 cycles, every 3 cycles (i.e. 9 weeks) during the subsequent cycles and at the End of Treatment (EOT) visit. After the EOT, the tumor assessments should be performed every 9 weeks.||||participants|||Number
1214202|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 Post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
1214203|NCT00777257|Secondary|Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.|Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.|0 to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population|||Percentage of participants|||Number
1214204|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
1214205|NCT00777257|Primary|Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.||Day 0 to Day 28 post-vaccination|Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population|||Percentage of participants|||Number
1214206|NCT00777205|Primary|Recovery Orientation|The 30-item Mental Health Recovery Measure (MHRM) was used to assess recovery orientation. The MHRM has been fielded among diverse populations and has a high level of internal consistency (Cronbach’s α =.93) and shows change following engagement in recovery oriented treatments. The MHRM is scored using a 5 point Likert Scale (0 to 4) for each item, yielding a theoretical range from 0 – 120 for Total Score. Higher scores correspond to a higher self-reported level of mental health recovery.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1214372|NCT00775645|Other Pre-specified|Serum Nerve Growth Factor Levels||12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
1214208|NCT00777205|Primary|Quality of Life|The 14-item Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), which has good reliability and has been used in multiple depression studies, was used to assess quality of life. Responses are scored on a 5-point scale (‘not at all or never’ to ‘frequently or all the time’), where higher scores indicate better enjoyment and satisfaction with life (possible range 14–70).|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1214209|NCT00777205|Primary|Change in Functional Status-Physical Health (PCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1214210|NCT00777205|Primary|Change in Functional Status-Mental Health (MCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1214211|NCT00777179|Secondary|Objective Response Rate (ORR)|"Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response.~Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response."|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||Participants|||Number
1214212|NCT00777179|Secondary|Disease of Response (DOR)|"Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response.~Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response"|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||Participants|||Number
1214213|NCT00777179|Secondary|Overall Survival (OS)|Overall survival (OS) defined as the median time from randomization to death from any cause.|Every 12 weeks unless the patient withdraws consent||||months||95% Confidence Interval|Median
1214214|NCT00777179|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||months||95% Confidence Interval|Median
1214215|NCT00777179|Primary|Progression-free Survival (PFS) Rate at 3 Months|Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.|12 weeks|The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set.|||Participants|||Number
1214216|NCT00777153|Secondary|Steroid Free Days|Number of days known not to have used any steroids prior to progression|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25||||Days||Standard Deviation|Mean
1214217|NCT00777153|Secondary|Daily Steroid Dose|The mean steroid dosage prior to treatment will be considered as the patient’s baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md – bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25||||percentage of change|||Number
1214218|NCT00777153|Secondary|Alive and Progression Free Rate at 6 Months (APF6)|Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.|6 Months||||% of patients alive and progression free|||Number
1214219|NCT00777153|Secondary|Response Rate|"An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.~An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan."|Baseline at 6 weeks and then every 6 weeks to discontinuation|Patients are only included in the analysis if they have measurable disease at baseline based on central.|||Participants|||Number
1214220|NCT00777153|Secondary|Overall Survival (OS)|Number of months from randomisation to the date of death from any cause|Baseline through to date of death up to 25th April 2010||||Months||Inter-Quartile Range|Median
1214259|NCT00777036|Primary|Complete Cytogenetic Response (CCyR) Rate|Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 3|||percentage of participants||95% Confidence Interval|Number
1214221|NCT00777153|Primary|Progression Free Survival (PFS)|"For patients with measurable disease at entry (at least one lesion that has a shortest diameter~≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:~The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.~The patient has died from any cause.~A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm."|Baseline at 6 weeks and then every 6 weeks to discontinuation||||Days||Inter-Quartile Range|Median
1214222|NCT00777101|Secondary|Time to CNS Metastases|Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).|From randomization date to first CNS symptom or lesions|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
1214223|NCT00777101|Secondary|Frequency of CNS Metastases (Frequency)|The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.|From randomization date to first CNS symptom or lesions|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants|||Number
1214224|NCT00777101|Secondary|Duration of Response|Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|From start date of response to first PD, assessed up to 69 months after the first subject was randomized.|No. of Subjects with either complete or partial response.|||months||95% Confidence Interval|Median
1214225|NCT00777101|Secondary|Clinical Benefit Rate|"Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.~Clinical Benefit (CB) = CR + PR + SD >= 24 weeks."|From randomization date to progression or last tumor assessment, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants||95% Confidence Interval|Median
1214226|NCT00777101|Secondary|Objective Response Rate (ORR).|Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From randomization date to progression or last tumor assessment, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants||95% Confidence Interval|Number
1214227|NCT00777101|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.|From randomization date to death, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
1214228|NCT00777101|Primary|Progression Free Survival|Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.|From randomization date to progression or death, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
1214229|NCT00777088|Secondary|Number of Participants With Device-related Adverse Events at 5 Years|Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement|5 years|Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement|||Participants|||Count of Participants
1214230|NCT00777088|Secondary|Number of Participants With Device-Related Adverse Events at 3 Years|Number of participants with incidence of device-related adverse events at 3 year follow-up|3 years||||Participants|||Count of Participants
1214231|NCT00777088|Secondary|Stenosis of the Parent Artery in PED at 5 Years|Parent artery stenosis at 5-year follow-up|5-years|Subjects that completed imaging at the 5-year follow-up were included in the parent artery stenosis analysis.|||Parent Artery Assessments|Parent Artery Assessments||Count of Units
1214232|NCT00777088|Secondary|Stenosis of the Parent Artery in PED at 3 Years|Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up|3-years|Subjects that completed imaging at the 3-year follow-up were included in the parent artery stenosis analysis.|||Parent Artery Assessments|Parent Artery Assessments||Count of Units
1214233|NCT00777088|Secondary|Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years|"The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:~Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac"|5 years|Pipeline treated subjects with observable data at 5 years|||Target Intracranial Aneurysms|Target Intracranial Aneurysms||Count of Units
1214234|NCT00777088|Secondary|Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up|"The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:~Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac"|3 years|Pipeline treated Subjects with observable data at 3 years|||Target Intracranial Aneurysms|Target Intracranial Aneurysms||Count of Units
1214235|NCT00777088|Secondary|Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year|"The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:~Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac"|1 Year|Pipeline treated subjects with observable data at 1 year|||Target Intracranial Aneurysms|Target Intracranial Aneurysms||Count of Units
1214236|NCT00777088|Primary|Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.|"The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:~Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac"|180 days|A total of 104 participants and 106 intracranial aneurysms treated with the Pipeline Embolization Device were included in the primary effectiveness endpoint analysis.|||Fully Occluded Intracranial Aneurysms|Fully Occluded Intracranial Aneurysms||Count of Units
1214237|NCT00777088|Primary|Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.|The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.|180-days and 5-years|Patients treated with one or more Pipeline Embolization Devices.|||Participants|||Count of Participants
1214238|NCT00777062|Primary|Time Line Follow Back -Reported Days of Abstinence From Drinking|Percentage of participants who were abstinent from drinking|8 week medication phase||||Percentage of Participants|||Number
1214239|NCT00777062|Primary|Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.|Percentage of subjects with no cocaine use for at least 3 weeks|8 week medication phase||||Percentage of Participants|||Number
1214240|NCT00777049|Primary|Objective Response Rate (as Determined by Investigator): the Percentage of Patients Assigned to a Treatment Arm With a Confirmed Best Response of CR or PR.|The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).|6 years and 2 months||||participants|||Number
1214241|NCT00777036|Secondary|Complete Molecular Response (CMR) Rate up to 2 Years|Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.|24 months|All randomized treated participants|||percentage||95% Confidence Interval|Number
1214242|NCT00777036|Secondary|Major Molecular Response (MMR) Rate up to 2 Years|Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant’s individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
1214243|NCT00777036|Secondary|Complete Cytogenetic Response (CCyR) Rate up to 2 Years|Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
1214244|NCT00777036|Secondary|Major Cytogenetic Response (MCyR) Rate up to 2 Years|Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
1214245|NCT00777036|Secondary|Complete Molecular Response (CMR) Rate|Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.|From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)|All treated participants|||percentage||95% Confidence Interval|Number
1214273|NCT00776984|Secondary|ACQ Score at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1214246|NCT00777036|Secondary|Major Molecular Response (MMR) Rate|Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant’s individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.|From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
1214247|NCT00777036|Secondary|Overall Survival (OS) Rate at 2 Years|OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.|2 years|All randomized and treated participants|||percentage||95% Confidence Interval|Number
1214248|NCT00777036|Secondary|Disease-Free Survival Rate at 2 Years|Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation.|2 years|All randomized treated participants with response of CCyR or CHR|||percentage||95% Confidence Interval|Number
1214249|NCT00777036|Secondary|Duration of Complete Hematologic Response (CHR)|Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.|From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)|All treated participants with CCyR|||months||95% Confidence Interval|Median
1214250|NCT00777036|Secondary|Time to Complete Hematologic Response (CHR)|Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.|From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)|All treated participants with CHR|||months||95% Confidence Interval|Median
1214251|NCT00777036|Secondary|Progression-Free Survival (PFS) Rate at 2 Years|"PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation.~Disease Progression was defined as any of the following criteria:~For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose~Increasing WBC~Loss of CHR (defined as any of the following: WBC count rises to >20.0x10^9/L; Platelet count rises to >600x10^9/L; appearance of extramedullary disease; appearance of >5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood)~Loss of MCyR or increase in Ph+ bone marrow cells by >=30% from nadir~Death from any case during treatment"|2 years|All treated participants|||percentage||95% Confidence Interval|Number
1214252|NCT00777036|Secondary|Duration of Complete Cytogenetic Response (CCyR)|Duration of CCyR will be computed from the first day criteria are met for CCyR until the date PD is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last.|From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)|All treated participants who achieved CCyR|||months||95% Confidence Interval|Median
1214253|NCT00777036|Secondary|Time to Complete Cytogenetic Response (CCyR)|Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR.|From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)|All treated participants with CCyR|||months||95% Confidence Interval|Median
1214254|NCT00777036|Secondary|Duration of Major Cytogenetic Response (MCyR)|Duration of MCyR will be computed from the first day criteria are met for MCyR until the date PD is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last.|From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)|All treated participants with MCyR|||months||95% Confidence Interval|Median
1214255|NCT00777036|Secondary|Time to Major Cytogenetic Response (MCyR)|Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR.|From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)|All treated participants with MCyR|||months||95% Confidence Interval|Median
1214256|NCT00777036|Secondary|Rate of Best Cytogenetic Response|The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|All treated participants|||percentage of participants|||Number
1214257|NCT00777036|Secondary|Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3|Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohorts 1 and 3|||percentage of participants||95% Confidence Interval|Number
1214260|NCT00777036|Primary|Complete Hematologic Response (CHR) Rate|Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 2|||percentage of participants||95% Confidence Interval|Number
1214261|NCT00777036|Primary|Major Cytogenetic Response (MCyR) Rate|Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 1|||percentage of participants||95% Confidence Interval|Number
1214262|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 12 weeks of treatment|Intent to treat population|||Units on a scale||95% Confidence Interval|Least Squares Mean
1214263|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 4 weeks of treatment|Intent to treat population|||Units on a scale||95% Confidence Interval|Least Squares Mean
1214264|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 12 weeks of treatment|Intent to treat population|||Hot flashes||95% Confidence Interval|Least Squares Mean
1214265|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 4 weeks of treatment|Intention to treat population|||Hot flashes||95% Confidence Interval|Least Squares Mean
1214266|NCT00776997|Secondary|Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline||12 months||||participants|||Number
1214267|NCT00776997|Secondary|At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline||12 months||||participants|||Number
1214268|NCT00776997|Primary|Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.|The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.|12 Months||||participants|||Number
1214269|NCT00776997|Primary|Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).|"SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria:~Results in death~Is life-threatening~Requires subject hospitalization > 24 hours~Requires prolongation of an existing hospitalization~Results in persistent or significant disability/incapacity~Results in fetal distress, fetal death, or a congenital anomaly or birth defect~Requires intervention to prevent permanent impairment or damage.~Outcome measure reports number of subjects with reported events."|through 24 months||||participants|||Number
1214270|NCT00776984|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).~This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)|||percentage of participants|||Number
1214271|NCT00776984|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Puffs||Standard Error|Mean
1214272|NCT00776984|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Days||Standard Error|Mean
1214373|NCT00775645|Other Pre-specified|Proportion of Patients Experiencing Grade 3 or 4 Neuropathy|Proportion of patients experiencing grade 3 or 4 neuropathy|12 weeks post-registration||||Participants|||Count of Participants
1214275|NCT00776984|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1214276|NCT00776984|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1214277|NCT00776984|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
1214278|NCT00776984|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
1214279|NCT00776984|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As < 50 percent (10 of 232 patients in the placebo group and 8 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
1214280|NCT00776984|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
1214281|NCT00776984|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
1214282|NCT00776984|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
1214283|NCT00776984|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
1214284|NCT00776984|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As < 50 percent (81 of 232 patients in the placebo group and 69 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
1214285|NCT00776984|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Percent||Standard Error|Mean
1214286|NCT00776984|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
1214287|NCT00776984|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
1214439|NCT00775437|Secondary|Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug.Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
1214288|NCT00776984|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
1214289|NCT00776984|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
1214290|NCT00776984|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214291|NCT00776984|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214292|NCT00776984|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214293|NCT00776984|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214294|NCT00776984|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214295|NCT00776984|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214296|NCT00776984|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214297|NCT00776984|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214298|NCT00776984|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214299|NCT00776984|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214300|NCT00776984|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||Days||Inter-Quartile Range|Median
1214301|NCT00776984|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214302|NCT00776984|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.|||Liter||Standard Error|Mean
1214303|NCT00776919|Secondary|Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation|An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.|Baseline (Day 1) through Week 12|ITT Population|||participants|||Number
1214304|NCT00776919|Secondary|Mean Duration of Study Product Use|Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.|Baseline (Day 1) through Week 12|ITT Population|||days||Standard Deviation|Mean
1214305|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging|Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.|||scores on a scale||Standard Deviation|Mean
1214306|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling|Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.|||scores on a scale||Standard Deviation|Mean
1214307|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Pulse Rate|Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
1214308|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Temperature|Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Degrees centigrade||Standard Deviation|Mean
1214309|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1214310|NCT00776919|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score >=2.|||participants|||Number
1214311|NCT00776919|Secondary|Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12|During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score >=2.|||participants|||Number
1214340|NCT00776100|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the date of randomization to the date at which the patient was removed from treatment (Arm II) or no treatment (Arm I) due to progression, adverse events, or refusal.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1214312|NCT00776919|Secondary|Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||Percent change in lesion counts||Standard Deviation|Mean
1214313|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Total Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||lesion counts||Standard Deviation|Mean
1214314|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||lesion counts||Standard Deviation|Mean
1214315|NCT00776919|Primary|Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or reported lost medication and never began treatment were excluded from the analysis. In the LOCF method, the last available observation, including BL, was used to estimate subsequent missing data points.|||lesion counts||Standard Deviation|Mean
1214316|NCT00776919|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12|During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Baseline (Day 1) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least 1 application of study product. Participants with missing Week 12 evaluations were considered failures. Failures are defined as those participants with a 1-grade improvement, no improvement, or a worsening.|||participants|||Number
1214317|NCT00776789|Secondary|Breast Feeding Status at 6 Weeks|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases|6 weeks||||percentage of partcipants|||Number
1214318|NCT00776789|Secondary|Breast Feeding Status at 48 Hours|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases.|48 hours|EBF rates were assessed using the standard WHO definitions. We asked the mothers about the method of feeding and the number and amount of supplemental feeds received in the first 2 days of life. Breastfeeding rates at 6 weeks were obtained by enquiring from the mothers at the time of the first vaccination of their infants in the follow-up clinic.|||percentage of partcipants|||Number
1214319|NCT00776789|Secondary|Salivary Cortisol|Saliva samples were collected with a Salivette. The infant had to suck on the swab for atleast 5 minutes. The prerequisite for collection of the saliva included that the infant should not have fed atleast 2 hours prior to the collection of the salivary sample. The filtrates were then transferred to a separate tube and were stored at 2-8º C for 24 hours. They were later transported to the central laboratory where the samples were stored at -20ºC and later analyzed using electrochemiluminescence immunoassay (ECLIA).|6 hours||||microgram/dl||Inter-Quartile Range|Median
1214339|NCT00776100|Secondary|Duration of Response|Duration of response was defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1214320|NCT00776789|Primary|The Median Breast Feeding Score|This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure [0 to 3] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more >=8.|36-48 hours by video recording||||scores||Inter-Quartile Range|Median
1214321|NCT00776659|Primary|Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.||||||
1214322|NCT00776659|Primary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.||||||
1214323|NCT00776659|Primary|Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.|Baseline up to 28 days after last dose of study treatment|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
1214324|NCT00776659|Primary|Number of Participants Who Discontinued Aromasin Therapy||Baseline until discontinuation (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
1214325|NCT00776659|Primary|Number of Participants Who Died||Baseline until death (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
1214326|NCT00776659|Primary|Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer||Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1214327|NCT00776659|Primary|Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer|Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.|Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1214328|NCT00776594|Secondary|Analysis of Cytokines and Angiogenic Factors in Plasma/Serum|Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).|6 months||||pg/ml||Inter-Quartile Range|Median
1214329|NCT00776594|Secondary|Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).|The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.|6 months||||participants|||Number
1214330|NCT00776594|Secondary|Number of Participants With PSA <0.2 ng/ml at Six Months|Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).|Six months (at completion of treatment)||||Number of participants|||Number
1214331|NCT00776594|Primary|Relapse-free Survival|To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.|2 years||||months||95% Confidence Interval|Median
1214332|NCT00776555|Secondary|DRQ-S, Question 3|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
1214333|NCT00776555|Secondary|DRQ-S, Question 1|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
1214334|NCT00776555|Primary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
1214335|NCT00776295|Secondary|3 Year Progression-free Survival|3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC|up to 3 years||||participants|||Number
1214336|NCT00776295|Primary|Number of Subjects Meeting 1-year Overall Survival|Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death|up to one year||||participants|||Number
1214337|NCT00776230|Secondary|Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability||see above|||||||
1214482|NCT00775190|Primary|Amount of Bleeding|Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).|6 Months|Study Terminated with no data analysis.||||||
1214341|NCT00776100|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|Time from registration to disease progression (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1214342|NCT00776100|Secondary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.|Time from registration to disease progression or death (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1214343|NCT00776100|Secondary|Response Rate|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations around 3 months apart. All participants with measurable disease (non-CR at baseline, etc.), meeting the eligibility criteria who have signed a consent form and have started the study were evaluable for response.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1214344|NCT00776100|Primary|Overall Survival|Overall survival was defined as the time from registration to the date of death or last follow-up|Time from registration to death or last follow-up (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1214345|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose|Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to “academic productivity.” A positive score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement.|||Number correct||Standard Error|Least Squares Mean
1214346|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose|Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to “academic productivity.” A positive score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Number attempted||Standard Error|Least Squares Mean
1214347|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
1214348|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
1214349|NCT00776009|Primary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
1214483|NCT00775021|Secondary|Overall Lens Handling|Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1214350|NCT00775983|Secondary|Participants Who Experienced Complications or Need for Additional Dilation|Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.|||participants|||Number
1214351|NCT00775983|Primary|Procedure Time|Procedure time to complete early second-trimester dilation and evacuation (D&E)|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.|||minutes||Standard Error|Mean
1214352|NCT00775944|Secondary|Use of Other NHS Smoking Cessation Interventions (e.g. Uptake of NHS Stop Smoking Services, Use of Other NRT Obtained From General Practitioner (GP) Etc.)|Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.|Measured 6 months after participant's quit date|||||||
1214353|NCT00775944|Secondary|Health Status at 6 Months EuroQol 5D (EQ5D)|This is a generic measure of health status used in health economic analyses.|Measured 6 months after participant's quit date|||||||
1214354|NCT00775944|Secondary|Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months|As title|Measured 6 months after participant's quit date|||||||
1214355|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month|Participants had to report not smoking for 7 or more days prior to outcome ascertainment.|Measured at 1 month after participant's quit date|All randomised cases|||participants|||Number
1214356|NCT00775944|Secondary|Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month|Prolonged abstinence was defined as not smoking between a quit date and one month later; minor lapses were permitted provided no more than 5 cigarettes in total had been smoked.|Measured at 1 month after participant's quit date|All randomised cases|||participants|||Number
1214357|NCT00775944|Secondary|Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months|Participants had to report not smoking in the three months prior to outcome ascertainment.|Measured at 6 months after participant's quit date|All randomised cases|||participants|||Number
1214358|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.|The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.|Measured 6 months after participant's quit date||||participants|||Number
1214359|NCT00775944|Primary|Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.|Prolonged abstinence was defined as not smoking between a quit date and six months later with minor smoking lapses permitted as long as no more than 5 cigarettes in total were smoked during this period.|6 months from participant's quit date|All randomised cases|||participants|||Number
1214360|NCT00775684|Primary|Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL)|AGRmin is performed during the 340mg/dl glucose clamp allows for estimation of the minimum alpha-cell glucagon secretion. Changes from baseline to 6 months of AGRmin were compared across groups.|Baseline and 6 months|"We conducted a randomized controlled trial in 40 adult subjects with early Type 2 diabetes (T2D) who received the~glucagon-like peptide (GLP-1) analog exenatide, the dipeptidyl peptidase IV inhibitor sitagliptin or the sulfonylurea glimepiride as an active comparator insulin secretagogue for 6 months."|||pg/mL||Standard Error|Mean
1214361|NCT00775684|Secondary|PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months|Between ∼60 and 250 mg/dL, the magnitude of AIRarg is a linear function of the plasma glucose level, so the difference in AIRarg at fasting and 230 mg/dL glucose levels divided by the difference in plasma glucose (ΔAIRarg/ΔPG) gives the glucose-potentiation slope (GPS) (8,24–26). Using the y-intercept (b) from the line created by these two points, the plasma glucose level at which half-maximal insulin secretion is achieved (PG50) is derived from solving the equation 1/2 (AIRmax) = (GPS · PG50) + b, and provides a measure of β-cell sensitivity to glucose The mean difference after 6 months in PG 50 were compared. Listed below are the PG50 values at baseline and 6 months.|Baseline and 6 months||||mg/dL||Standard Error|Mean
1214362|NCT00775684|Secondary|Insulin Sensitivity at Baseline and 6 Months|Insulin sensitivity (M/I) was determined by dividing the mean glucose infusion rate required during the 230 mg/dL glucose clamp (M) by the mean prestimulus insulin level (I) between 40 and 45 min of the glucose infusion The mean difference after 6 months in insulin sensitivity (M/I) were compared|Baseline and 6 months||||((mg/kg) /min) /uU/mL||Standard Error|Mean
1214363|NCT00775684|Secondary|Change in Acute Insulin Response to Arginine. (AIRarg)|The changes in B-cell insulin secretion, Acute Insulin Response to arginine (AIRarg) after 6 months were compared to baseline AIRarg for each group. Listed below are AIRarg at baseline and 6 months for each group.|Baseline and 6 months||||uU/mL||Standard Error|Mean
1214364|NCT00775684|Primary|Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml)|The acute insulin response to arginine (AIRarg) performed during the 340mg/dl glucose clamp allows for estimation of the the beta-cell secretory capacity (AIRmax) or functional beta-cell mass. Changes from baseline to 6 months of AIRmax were compared across groups|Baseline and 6 months|"We conducted a randomized controlled trial in 40 adult subjects with early Type 2 diabetes (T2D) who received the~glucagon-like peptide (GLP-1) analog exenatide, the dipeptidyl peptidase IV inhibitor sitagliptin or the sulfonylurea glimepiride as an active comparator insulin secretagogue for 6 months."|||μU/ml||Standard Error|Mean
1214365|NCT00775671|Primary|Marker of Fibrinolysis|Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.|After 12 weeks of study drug||||ng/mL||Standard Deviation|Mean
1214366|NCT00775671|Secondary|Measurement of Insulin Sensitivity|The change in insulin sensitivity index, from baseline to after 12 weeks of treatment. Calculated from the intravenous glucose tolerance test at baseline and at 12 weeks.|3 hours||||10-4xmin-1 per mU/L||Standard Deviation|Mean
1214958|NCT00772070|Primary|Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.||Day 0 and Days 8 and 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1214374|NCT00775645|Secondary|12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups|Compare fatigue outcome between treatment and placebo groups as measured by the 13-item Functional Assessment of Chronic Illness Therapy FACIT-fatigue questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate more fatigue. Total possible range is 0 to 52. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||FACIT-fatigue score||Full Range|Mean
1214375|NCT00775645|Secondary|12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups|Compare FACT-TOI outcome in treatment vs placebo groups at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse functional status. Total possible range is 0 to 120. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||units on a scale||Full Range|Mean
1214376|NCT00775645|Primary|12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups|Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||units on a scale||Full Range|Mean
1214377|NCT00775606|Secondary|Response to Immunization With Pneumococcus Polysaccharide and Tetanus-diphtheria Vaccines|Response to immunization with pneumococcus polysaccharide and tetanus-diphtheria vaccines was not done due to small sample size|4 weeks after treatment initiation|||||||
1214378|NCT00775606|Secondary|Activated and Regulatory CD4+ and CD8+ T-cell Frequencies||4, 12 and 24 weeks after treatment initiation|||||||
1214379|NCT00775606|Secondary|Naive, Central Memory and Effector Memory CD4+ and CD8+ (Cluster of Differentiation 8) T-cell Frequency||4, 12 and 24 weeks after treatment initiation|||||||
1214380|NCT00775606|Secondary|CD4+ T-cell Change|This measures the change in CD4+ T-cells from baseline to week 24 of treatment.|24 weeks after treatment initiation (baseline and week 24)||||cells/mm3||Standard Deviation|Mean
1214381|NCT00775606|Primary|CD4+ (Cluster of Differentiation 4) T-cell Apoptosis|Change in the percentage of naive CD4 T-cells undergoing apoptosis as measured by propidium iodide staining. This is a lab test that measures the percentage of naive CD4 T-cells that are undergoing cell death. The change in this measure is obtained by determining the difference between the percentage of naive CD4 T-cells undergoing apoptosis at week 24 of treatment and the percentage undergoing apoptosis at baseline.|24 weeks from treatment initiation (baseline and week 24)||||per cent||Standard Deviation|Mean
1214382|NCT00775593|Secondary|Duration of Survival||At 2 years from study entry||||months||Full Range|Median
1214383|NCT00775593|Secondary|Duration of Response|Participants who responded to treatment|At 2 years from study entry||||months||Standard Deviation|Mean
1214384|NCT00775593|Secondary|Number of Serious Adverse Events Within 2 Years||At 2 years from study entry||||serious adverse events|||Number
1214385|NCT00775593|Primary|Complete Response Rate||At 2 years from study entry||||participants|||Number
1214386|NCT00775528|Primary|Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)|Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.|10 Days||||Participants|||Number
1214387|NCT00775528|Secondary|Total Calorie Intake (kcal)|The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Kcal||Standard Deviation|Mean
1214388|NCT00775528|Secondary|Fat Intake (g)|The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Grams||Standard Deviation|Mean
1214389|NCT00775528|Secondary|Stool Fat (% Fat)|The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day).|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Percentage of fat||Standard Deviation|Mean
1214390|NCT00775463|Secondary|Time to Ulcer Healing|A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as “healed” and no new ulcers appeared for the remainder of the trial. The time to complete healing of all ulcers were calculated as the number of days from randomization to the date of these respective assessments, provided that complete healing was achieved during the study.|Week 20||||days||Standard Deviation|Mean
1214391|NCT00775463|Secondary|Time to Ulcer Healing- Percentage of Subjects With Complete Healing|A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as “healed” and no new ulcers appeared for the remainder of the trial.|Week 20||||percentage of participants|||Number
1214399|NCT00775463|Secondary|Patient Global Assessment of Digital Ulcer Severity VAS|"Patients rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).~The term “severity” was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1214392|NCT00775463|Secondary|Short Form 36|Change in patient quality of life was measured by the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), a self-administered questionnaire covering eight areas: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health. For each area, the score range from 0 (poorer health status) to 100 (better health status). The SF-36 is one of the most widely used and validated instruments to assess quality of life in patients with systemic illnesses. A decrease (negative change) in a domain score corresponds to deterioration.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1214393|NCT00775463|Secondary|Patient Impression of Change (PIC) Questionnaire|The PIC questionnaire consisted of three Likert items that asked the subject to rate changes in their digital ulcer, Raynaud’s phenomenon and disease status since their last visit on a seven-level scale (very much improved, much improved, somewhat improved, same, somewhat worse, much worse and very much worse).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||participants|||Number
1214394|NCT00775463|Secondary|Short-Form McGill Pain Questionnaire|The SF-MPQ assessment has three component scores: the pain rating index (PRI), a pain visual analogue numerical scale (Pain VAS) and the present pain intensity (PPI). PRI is calculated by summing the responses (0=None to 3=Severe) to the 15 questions describing pain during the previous week and rated on an intensity scale as 0= none, 1= mild, 2= moderate or 3= severe and has possible values ranging from 0 to 45. The Pain VAS is a 100 mm VAS on which subjects were asked to rate pain during the previous week with values ranging from no pain (0.0) to worst possible pain (10.0). The PPI rated pain on a 6-point category scale from 0 (no pain) to 5 (excruciating pain).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1214395|NCT00775463|Secondary|Modified Rodnan Skin Score (mRSS)|The skin thickening was assessed by the Investigator in 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each area was scored 0–3; 0 representing normal skin and 3 being severe thickening. The mRSS was the sum of the individual skin assessment scores: possible range of 0-51; 0 (no thickening) to 51 (severe thickening in all 17 areas) .|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1214396|NCT00775463|Secondary|Scleroderma Health Assessment Questionnaire (SHAQ)|The SHAQ is a patient self-administered instrument which has been previously validated in SSc and demonstrates meaningful clinical changes in the course of the disease over time. It is comprised of a 20 question instrument pertaining to specific activities with possible integer responses of 0 (without any difficulty) to 3 (unable to do), and five additional scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud’s Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with possible values ranging from 0.0 to 15.0. The 20 questions are divided into eight domains. A mean score is calculated for each domain ranging from 0 to 3. A composite HAQ DI score is calculated by dividing the summed domain scores by the number of domains answered. The composite score is reported, falling between 0 and 3 on an ordinal scale. The scores are interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1214397|NCT00775463|Secondary|Cochin Hand Function Scale (CHFS)|The CHFS has been demonstrated as a reliable and valid assessment of hand function at the activity level in persons with SSc. It is comprised of 18 questions with possible integer responses of 0 (without difficulty) to 5 (impossible). The CHFS Score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS Score values can range from 0 (least limitation) to 90 (most limitation). A higher score indicates more difficulty in hand function or greater disability.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||95% Confidence Interval|Median
1214398|NCT00775463|Secondary|Physician Global Assessment of Digital Ulcer Severity VAS|"Physicians rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).~The term “severity” was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1214438|NCT00775437|Secondary|Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
1214400|NCT00775463|Secondary|Digital Ulcer Pain VAS|Digital ulcer pain was rated on a 100-mm VAS on which subjects were asked to rate their average overall hand pain during the last week. The recorded value was divided by 10, with values ranging from 0.0 (no pain) to 10.0 (unbearable pain), expressed to one decimal.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1214401|NCT00775463|Primary|Net Ulcer Burden|Net ulcer burden was defined as the number of “new” or “active” digital ulcers (DU), plus the number of “indeterminate” DUs at that assessment that have previously been classified as either “active” or “new” at any earlier assessment during the study. A DU was defined as an area with visually discernable depth and a loss of continuity of epithelial coverage, which could be denuded or covered by a scab or necrotic tissue. If denuded, the DU was pronounced “active.” If denudation could not be judged because of the presence of scab or necrotic tissue, DU presenting with features, including underlying pain, based on Investigator clinical judgment to be consistent with loss of epithelialization, epidermis, or dermis, and requiring treatment were designated as “active.” Otherwise, the DU was pronounced “indeterminate.” Only DUs distal to the proximal interphalangeal joints, volar to the equator of the finger, not localized in creases and vascular in origin were assessed.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change.|||ulcers||Inter-Quartile Range|Median
1214402|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
1214403|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.|Days 0 and 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
1214404|NCT00775450|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1214405|NCT00775450|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.|Days 0 through 7 post vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Participants|||Number
1214406|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214407|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214408|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214409|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1220409|NCT00732940|Secondary|Median Percent Change From Baseline in HDL at Week 24||Baseline, 24 week|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1214410|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214411|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214412|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214413|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214414|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214415|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214416|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214417|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations – Physical Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214418|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1220410|NCT00732940|Secondary|Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
1214419|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.||||units on a scale||Standard Deviation|Mean
1214420|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214421|NCT00775437|Secondary|Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit|"Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214422|NCT00775437|Secondary|Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit|"Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present (1), absent (0) or replaced/injected (9). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214423|NCT00775437|Secondary|Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit|"Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present (1), absent (0) or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214424|NCT00775437|Secondary|C-reactive Protein (CRP): Mean Change From Baseline to Each Visit|CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||mg/dL||Standard Deviation|Mean
1214425|NCT00775437|Secondary|Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit|"Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214426|NCT00775437|Secondary|Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit|A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214427|NCT00775437|Secondary|Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit|The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214428|NCT00775437|Secondary|Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The parent’s assessment of how the participant’s arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214429|NCT00775437|Secondary|Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The physician’s assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1214430|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)|The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
1214431|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)|The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
1214432|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)|The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
1214433|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)|The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion [LOM] and joints with pain on passive motion [POM], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
1214434|NCT00775437|Secondary|Uric Acid: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
1214435|NCT00775437|Secondary|Creatinine: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
1214436|NCT00775437|Secondary|Total Bilirubin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
1214437|NCT00775437|Secondary|Creatine Phosphokinase: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
1214484|NCT00775021|Secondary|Initial Comfort|Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 Week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1214440|NCT00775437|Secondary|Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
1214441|NCT00775437|Secondary|Basophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
1214442|NCT00775437|Secondary|Eosinophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
1214443|NCT00775437|Secondary|Monocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
1214444|NCT00775437|Secondary|Lymphocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
1214445|NCT00775437|Secondary|Neutrophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
1214446|NCT00775437|Secondary|White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
1214447|NCT00775437|Secondary|Platelets: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
1214448|NCT00775437|Secondary|Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄12/L||Standard Deviation|Mean
1214449|NCT00775437|Secondary|Hematocrit: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||Fraction||Standard Deviation|Mean
1214450|NCT00775437|Secondary|Hemoglobin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||g/L||Standard Deviation|Mean
1214451|NCT00775437|Secondary|Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24|Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.|Weeks 0, 12, and 24|All participants who had samples for pharmacokinetic analysis|||µg/mL||Standard Deviation|Mean
1214452|NCT00775437|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).|TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).||||participants|||Number
1214453|NCT00775411|Secondary|Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).|Baseline, Week 26|Participants from the Intent to treat population consisting of all enrolled participants with data available for analysis at Week 26.|||Percentage of participants|||Number
1214485|NCT00775021|Secondary|End of the Day Comfort|Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1214454|NCT00775411|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 26|Intent to treat population consisting of all enrolled participants.|||Number of letters||Standard Deviation|Mean
1214455|NCT00775411|Primary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.|Baseline, Week 4|Participants from the Intent to treat Population consisting of all enrolled participants with data available at Week 4 for analyses.|||Microns||Standard Deviation|Mean
1214456|NCT00775346|Primary|Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).|Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP).|9 Hours||||Ratio||90% Confidence Interval|Mean
1214457|NCT00775229|Secondary|Liver Function Tests|Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).|Week 8 (last visit)||||percentage of individuals with LFT chang|||Number
1214458|NCT00775229|Secondary|Massachusetts General Hospital Hairpulling Scale|Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).||||units on a scale||Standard Deviation|Mean
1214459|NCT00775229|Primary|National Institute of Mental Health Trichotillomania Symptom Severity Scale|Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).||||units on a scale||Standard Deviation|Mean
1214460|NCT00775203|Secondary|Discontinuation Due to Lack of Efficacy|Number of patients who discontinued due to lack of efficacy during the whole study period (8 weeks).|Baseline to Week 8|Safety population is defined as all randomized patients who received any study medication.|||participants|||Number
1214461|NCT00775203|Secondary|Awakening During the Night at Each Visit|"Awakening during the night was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit did you awaken during the night?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1214462|NCT00775203|Secondary|Trouble Falling Asleep at Each Visit|"Trouble Falling Asleep was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit, how often did you experience trouble falling asleep?."|Weeks 1, 2, 3, 4, 6, 8|Full Analysis set (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1214463|NCT00775203|Secondary|Overall Quality of Sleep at Each Visit|"Overall Quality of Sleep was measured on a 4-point rating scale ranging from 1 = very poor to 4 = excellent in response to the question: Since the last study visit, how would you rate the overall quality of your sleep?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Points on a scale||Standard Deviation|Mean
1214464|NCT00775203|Secondary|Patient Global Impression – Improvement of Illness (PGI-I) Responders at Last Study Visit|Patients were responders if the PGI-I rating was “Much Improved” or “Very Much Improved”. The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: “Since the start of the study, my overall status with regard to depression is?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Responders Week 8 Observed Cases: Trazodone = 176, placebo = 183.|||participants|||Number
1214465|NCT00775203|Secondary|Clinical Global Impression – Improvement of Illness (CGI-I) Responders at Last Study Visit|Patients were responders if the CGI-I rating was “Much Improved” or “Very Much Improved”. The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Responders Week 8 Observed Cases: Trazodone = 180, placebo = 183.|||participants|||Number
1214731|NCT00773513|Secondary|Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
1214466|NCT00775203|Secondary|Patient Global Impression – Improvement of Illness (PGI-I) Score at Last Study Visit|The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: “Since the start of the study, my overall status with regard to depression is?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Week 8 Observed Cases: Trazodone = 176, placebo = 183.|||Units on PGI-I scale||Standard Deviation|Mean
1214467|NCT00775203|Secondary|Clinical Global Impression – Improvement of Illness (CGI-I) Score at Last Study Visit|The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Week 8 Observed Cases: Trazodone = 178, placebo = 182.|||Units on the CGI-I scale||Standard Deviation|Mean
1214468|NCT00775203|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Each Visit|The CGI-Severity (CGI-S) consists of one question for the investigator: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on CGI-S scale||Standard Deviation|Mean
1214469|NCT00775203|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10 item clinician-administered depression rating scale. The 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) are rated on a scale ranging from 0 (low severity/difficulty) to 6 (high severity/difficulty) with anchors at 2-point intervals. The overall total score range is from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. MADRS Week 8 Observed Cases: Trazodone = 178, placebo = 182.|||Units on MADRS scale||Standard Deviation|Mean
1214470|NCT00775203|Secondary|Change in HAMD-17 Depressed Mood Item (Item 1) Score From Baseline to Each Visit|Change from baseline in the HAMD-17, item 1: Depressed Mood item, at each post-baseline visit. The Depressed Mood item is rated on a 5-point scale ranging from rating of 0=absent; to 4=very severe.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Points on the HAMD scale||Standard Deviation|Mean
1214471|NCT00775203|Secondary|HAMD-17 Remitters at Each Visit|Number of patients who are remitters (defined as patients who achieved a HAMD-17 total score ≤7) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Participants|||Number
1214472|NCT00775203|Secondary|HAMD-17 Responders at Each Visit|Number of patients who show a response (defined as at least a 50% reduction from baseline in HAMD-17 score) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Participants|||Number
1214473|NCT00775203|Primary|Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline|The Hamilton Depression Rating Scale 17 items [HAMD-17] is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Week 8 Last Observation Carried Forward (LOCF): Trazodone = 202, placebo = 204.|||Points on HAMD-17 scale||Standard Deviation|Mean
1214474|NCT00775190|Secondary|Side Effects (Incidence of Thromboembolic Events)|Occurrence of any thromboembolic events during the study time frame.|6 months|Study Terminated with no data analysis||||||
1214475|NCT00775190|Secondary|Side Effects (Menstrual Cramps)|Intensity of menstrual cramps reported on a 4 point Likert scale.|6 months|Study Terminated with no data analysis||||||
1214476|NCT00775190|Secondary|Side Effects (Mood Changes)|Self reported changes in mood during each month over the time frame.|6 months|Study Terminated with no data analysis||||||
1214477|NCT00775190|Secondary|Side Effects (Breast Tenderness)|Incidence of breast tenderness during the study time frame|6 Months|Study Terminated with no data analysis||||||
1214478|NCT00775190|Secondary|Side Effects (Vomiting)|Number of episodes of vomitting|6 Months|Study Terminated with no data analysis||||||
1214479|NCT00775190|Secondary|Side Effects (Nausea)|Number of days of nausea|6 months|Study Terminated with no data analysis||||||
1214480|NCT00775190|Primary|Days of Bleeding|Number of days with bleeding during each menstrual period.|6 months|Study Terminated with no data analysis||||||
1214481|NCT00775190|Primary|Incidence of Breakthrough Bleeding|Any breakthrough bleeding during reporting period.|6 months|Study Terminated with no data analysis||||||
1214486|NCT00775021|Secondary|Inferior Region Corneal Staining|The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1214487|NCT00775021|Primary|Overall Comfort|Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1214488|NCT00774995|Secondary|Number of Subjects That Experienced Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period after the challenge dose (1 month).||||Subjects|||Number
1214489|NCT00774995|Secondary|Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination.|During the 31-day follow-up period after the hepatitis B vaccine challenge dose.||||Subjects|||Number
1214490|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
1214491|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
1214492|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
1214493|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA.|Cut-off values assessed were as follows: ≥6.2 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
1214494|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA.|Cut-off values assessed were as follows: ≥3.3 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
1214495|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
1214496|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||μmol/day||Standard Deviation|Mean
1214497|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||μg/L||Standard Deviation|Mean
1214498|NCT00774930|Secondary|Changes From Baseline in QoL in “Endocrine Symptoms” Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.~For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
1214499|NCT00774930|Secondary|Changes From Baseline in “Gastrointestinal (G.I). Symptoms” Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.~For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
1214500|NCT00774930|Secondary|"Changes From Baseline in Global Health Status/Quality of Life (QoL) Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)"|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.~For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
1214501|NCT00774930|Secondary|Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study|Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of subjects|||Number
1214502|NCT00774930|Secondary|Percentage of Days of Use of Other Rescue Medication|Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of days||Standard Deviation|Mean
1214503|NCT00774930|Secondary|Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Number of events per day||Standard Deviation|Mean
1214504|NCT00774930|Secondary|Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Number of events per day||Standard Deviation|Mean
1214505|NCT00774930|Primary|Percentage of Days With Subcutaneous Octreotide as Rescue Medication|Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of days||95% Confidence Interval|Least Squares Mean
1214534|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7|Comparing anti-Xa levels from the first day of using the port and the last day of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|7 days|All participants, excluding two outliers of 97% and 150%|||Percent||Full Range|Median
1214506|NCT00774852|Secondary|Proportion of Vaccinated Participants With a Competent Immune Response|"Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:~Pneumococcal vaccination response – absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.~Tetanus toxoid vaccination response – absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer~Competent immune response is indicative of low disease activity."|Week 52|Intent-to-treat who completed Week 52 and were vaccinated.|||percentage of participants|||Number
1214507|NCT00774852|Secondary|Lupus Disease Activity – Total BILAG-2004|BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.|Week 52|Intent-to-treat who completed Week 52 and BILAG 2004 data available.|||units on a scale||Standard Deviation|Mean
1214508|NCT00774852|Secondary|Lupus Disease Activity – SF-36 Scores Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.|||percent change||Standard Deviation|Mean
1214509|NCT00774852|Secondary|Lupus Disease Activity – SF-36 Scores|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.|||Score||Standard Deviation|Mean
1214510|NCT00774852|Secondary|Lupus Disease Activity – Patient Global Assessment Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.|||percent change||Standard Deviation|Mean
1214511|NCT00774852|Secondary|Lupus Disease Activity – Patient Global Assessment|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.|||units on a scale||Standard Deviation|Mean
1214512|NCT00774852|Secondary|Lupus Disease Activity – Frequency of Flares|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity."|Week 52|Intent-to-treat with available data between weeks 24 and 52.|||participants|||Number
1214513|NCT00774852|Secondary|Lupus Disease Activity – Presence of Hypocomplementemia|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus."|Week 104|Intent-to-treat participants who completed Week 104 and had hypocomplementemia data available|||participants|||Number
1214552|NCT00774397|Secondary|Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure|Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Systolic blood pressure and Diastolic blood pressure at Week 24)|||mmHg||Standard Deviation|Mean
1214514|NCT00774852|Secondary|Lupus Disease Activity – Negative Anti-dsDNA|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity."|Week 104|Intent-to-treat participants who completed Week 104.|||participants|||Number
1214515|NCT00774852|Secondary|Lupus Disease Activity – Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity."|Week 104|Participants from Intent-to-treat population who had positive anti-dsDNA at baseline and completed Week 104.|||participants|||Number
1214516|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response|A participant who did not meet the criteria for either a complete response (CR) or a partial response (PR) at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the investigator judged that the participant may benefit from continued participation. CR definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a CR. PR definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline, and prednisone dose has been tapered to 10 mg/day.|Week 52|Intent-to-treat||||||
1214517|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study|A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe.|Week 104|Intent-to-treat|||participants|||Number
1214518|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response|A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
1214519|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response|A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
1214520|NCT00774852|Secondary|Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis.|Week 52|Intent-to-treat|||participants|||Number
1214521|NCT00774852|Secondary|Number of Participants With a Complete or Partial Response|"Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.~Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.~Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis."|Week 52|Intent-to-treat|||participants|||Number
1214522|NCT00774852|Secondary|Number of Participants With Partial Response|Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
1215173|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
1214523|NCT00774852|Primary|Number of Participants With Complete Response|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
1214524|NCT00774800|Secondary|Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG])|AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 140 milligrams per deciliter (mg/dL) within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before; at 3, 6, 9, 12, 15, 20, 25 minutes; and every 10 minutes from minute 30 to 240 postdose.|Predose up to 4 hours after injection of study drug|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC(BG) data.|||minutes*milligrams per deciliter||90% Confidence Interval|Geometric Mean
1214525|NCT00774800|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable tmax data.|||minutes||Standard Deviation|Mean
1214526|NCT00774800|Secondary|Maximum Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable Cmax data|||Picomoles per liter (pmol/L)||Standard Deviation|Mean
1214527|NCT00774800|Primary|Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)|AUC was derived as the area under the serum insulin concentration profile from 0 to time “t.” Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose.|Predose up to 60 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC0-60 data.|||nanomole*minute per liter (nmol*min/L)||Standard Deviation|Mean
1214528|NCT00774787|Other Pre-specified|Local Skin Reactions|Mean maximum post-baseline intensity of investigator assessed local skin reactions (erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, erosion/ulceration) by treatment area. 0 = none, 1 = mild, 2 = moderate, 3 = severe. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|Post baseline to end of study (4-8 weeks post-treatment)|One patient not included who was lost to follow-up immediately after baseline visit, and had no post-treatment data.|||Scores on a scale||Standard Deviation|Mean
1214529|NCT00774787|Secondary|Cosmetic Appearance Score at 4-8 Weeks Post-treatment|Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|4-8 weeks post-treatment|Patients who had end of study visit with cosmetic appearance assessment. Cosmetic appearance score, by treatment area, not included for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data.|||Scores on a scale||Standard Deviation|Mean
1214530|NCT00774787|Post-Hoc|Complete Clearance of Actinic Keratoses at 4-8 Weeks Post-treatment|Complete clearance (actinic keratosis count of 0) in each respective area at 4-8 weeks post-treatment. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|4-8 weeks post-treatment|All patients enrolled.|||Participants|Participants||Number
1214531|NCT00774787|Primary|Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment|Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|Baseline, 4-8 weeks post-treatment|Patients who had end of study visit with count of actinic keratoses. Change not calculated for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline or new.|||Percent change||Standard Deviation|Mean
1214532|NCT00774748|Secondary|Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)|GFR was calculated from a creatinine blood level to establish a safe renal function that would validate anti-Xa levels. Low molecular weight heparin is primarily cleared from the body by the kidneys. Any condition that decreases kidney function can potentially decrease LMWH clearance, increasing its concentration in the blood and increasing the potential for excessive bleeding.|6 time points in approximately 3 months|Included all participants who had at lease one visit and one blood draw.|||mL/min||Full Range|Mean
1214533|NCT00774748|Primary|Average Subcutaneous Anti-Xa Blood Levels|Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.|approximately 3 months|Participants were separated into the two dosing schedules, since the target anti-Xa level is different for the two different types of doses. The once daily dosing sub-group was analyzed for this primary outcome measure.|||IU/mL||Full Range|Mean
1220582|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|3 month after enrollment|Modified intention to treat analysis|||Participants|||Number
1214535|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port|Comparing subcutaneous baseline (without port) anti-Xa levels with day one of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|approximately 3 months|Twenty participants, excluding one outlier of 97%.|||Percent||Full Range|Median
1214536|NCT00774748|Secondary|Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels|Anti-Xa subcutaneous blood levels are displayed in percent difference to show normal fluctuations of anti-Xa levels without using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|6 time points (for each participant) in approximately 3 months|All participants were represented with a baseline fluctuation in percent difference.|||Percent||Full Range|Median
1214537|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of PegIFN at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1214538|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1214539|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1214540|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Faldaprevir at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1214541|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline Total Bilirubin)|||percentage of patients|||Number
1214542|NCT00774397|Secondary|Change From Baseline to Week 24 in Total Bilirubin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Total Bilirubin at Week 24)|||mg/dL||Standard Deviation|Mean
1214543|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline ALT/GPT,SGPT)|||percentage of patients|||Number
1214544|NCT00774397|Secondary|Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients|Baseline is defined as the last value before the drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in ALT/GPT,SGPT at Week 24)|||U/L||Standard Deviation|Mean
1214545|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Absolute Neutrophils)|||percentage of patients|||Number
1214546|NCT00774397|Secondary|Change From Baseline to Week 24 in Absolute Neutrophils of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Absolute Neutrophils at Week 24)|||GI/L||Standard Deviation|Mean
1214547|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Haemoglobin)|||percentage of patients|||Number
1214548|NCT00774397|Secondary|Change From Baseline to Week 24 in Haemoglobin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Haemoglobin at Week 24)|||g/dL||Standard Deviation|Mean
1214549|NCT00774397|Secondary|Global Assessment of Tolerability|"The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation.~Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'."|Week 24|Per protocol set|||percentage of patients|||Number
1214550|NCT00774397|Secondary|Change From Baseline to Week 24 in Weight of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Weight at Week 24)|||kg||Standard Deviation|Mean
1214551|NCT00774397|Secondary|Change From Baseline to Week 24 in Pulse Rate|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Pulse rate at Week 24)|||bpm||Standard Deviation|Mean
1214553|NCT00774397|Secondary|Relapse|"Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection.~Patients could experience relapse at any point post-treatment."|post-End of treatment (i.e. post 48 weeks)|Per protocol set|||percentage of patients|||Number
1214554|NCT00774397|Secondary|Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)|Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.|Week 24 through Week 48|Per protocol set|||percentage of patients|||Number
1214555|NCT00774397|Secondary|Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)|Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.|Up to Week 24|Per protocol set|||percentage of patients|||Number
1214556|NCT00774397|Secondary|Virological Rebound|"Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection.~Note that this is numerical rebound, not requiring confirmation with a re-measurement."|Week 24 or Week 48|Per protocol set|||percentage of patients|||Number
1214557|NCT00774397|Secondary|Time to Loss of Virological Response|"Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero.~Time is expressed in Median number of days."|Week 24|Per protocol set|||Number of days||95% Confidence Interval|Median
1214558|NCT00774397|Secondary|Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection|Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)|On or after day 155 post end of all treatment|Per protocol set|||Days||Full Range|Median
1214559|NCT00774397|Secondary|Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy|Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60|Week 36 or Week 60|Per protocol set|||percentage of patients|||Number
1214560|NCT00774397|Secondary|End of Treatment Response at End of All Therapy|End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48|Week 24 or Week 48|Per protocol set|||percentage of patients|||Number
1214561|NCT00774397|Secondary|End of Treatment Response at Week 24|End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24.|Week 24|Per protocol set|||percentage of patients|||Number
1214562|NCT00774397|Secondary|Complete Early Virological Response (cEVR)|Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12|Week 12|Per protocol set|||percentage of patients|||Number
1214563|NCT00774397|Secondary|Extended Rapid Virological Response (eRVR)|Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12|Week 4 and Week 12|Per protocol set|||percentage of patients|||Number
1214564|NCT00774397|Secondary|Early Virological Response (EVR)|Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12|Baseline and Week 12|Per protocol set|||percentage of patients|||Number
1214565|NCT00774397|Secondary|Virological Response at Week 4|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)|Week 4|Per protocol set|||percentage of patients|||Number
1214566|NCT00774397|Secondary|Virological Response at Week 2|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)|Week 2|Per protocol set|||percentage of patients|||Number
1214567|NCT00774397|Primary|Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy|"Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection.~The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24.~Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved."|Day 155 after the end of all treatment|Per protocol set|||percentage of patients||95% Confidence Interval|Number
1214568|NCT00774397|Primary|Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo|"An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD).~This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48.~The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'."|Week 28|"Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations .~FAS was composed of all randomised patients who took at least 1 dose of study medication.~For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated."|||percentage of patients|||Number
1214569|NCT00774306|Secondary|Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)||8 weeks, 16 weeks|||||||
1214570|NCT00774306|Primary|Change in Serum Cholesterol, Non-HDL Cholesterol, HDL Cholesterol, Lipoprotein(a), and C-reactive Protein From Baseline to Second Draw and Third Draw in Each of the 4 Study Arms||8 weeks, 16 weeks|||||||
1214732|NCT00773513|Secondary|Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
1214571|NCT00774267|Primary|Percent Change From Baseline in Mammographic Breast Density at Month 24|The digitized mammogram pairs were analyzed by a single trained radiologist who determined the density of the breast using software. The only left craniocaudal view was used for assessing breast density.|primary study baseline, Month 24|All available participants were analyzed. Here, ‘N’ (number of participants analyzed) signifies those participants who had technically acceptable mammograms available at primary study baseline and Month 24.|||percent change||Standard Deviation|Mean
1214572|NCT00774202|Secondary|Relative Efficacy of the 2 Groups|The goal is to see if there are major differences between the two arms for each group in term of efficacy and of toxicity both overall and in comparison to the previous responses to rituximab alone. The comparisons are for level of response eg CR (>100k) vs PR (230-100k) vs NR (<30k) and for duration of response-----duration of response is controlled by comparison to duration of response from initial rituximab infusions|2 years||||number of responders|||Number
1214573|NCT00774202|Secondary|Number of Participants With SAEs|How many participants had SAEs among those receiving R-CVP or among those receiving double dose rituximab and di participants in one arm have substantially more SAEs than those in the other arm|2 years||||number of patients with SAEs|||Number
1214574|NCT00774202|Primary|Efficacy of Higher Double Doses of Rituxan and of Standard Dose of Rituxan + Cyclophosphamide, Vincristine, Prednisone|"Outcome measure was determined by comparing the study participants' historical responses to their initial treatment of rituximab at standard dose/regimen without enhancement (based on duration of response and type of response) to the participants response to their study treatment responses. Thus each patient was his or her own control although all study treatments included standard dose rituximab treatments (one at double the dose and one with additional treatments)."|2 years|the number of patients in each arm that increase their platelet count consistently above 100,000/uL after treatment|||Participants|||Count of Participants
1214575|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1214576|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1214577|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1214578|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1214579|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1214580|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1214581|NCT00774163|Primary|Serum Creatinine||Day 5||||mg/dl||Standard Deviation|Mean
1214582|NCT00774163|Primary|Blood Urea Nitrogen||Day 5||||mg/dl||Standard Deviation|Mean
1214583|NCT00774163|Primary|Serum AST in Males||Day 5|limited to males|||units per liter (U/L)||Standard Deviation|Mean
1214584|NCT00774163|Primary|Serum Aspartate Aminotransferase (AST) in Females||Day 5|limited to females|||units per liter (U/L)||Standard Deviation|Mean
1214585|NCT00774163|Primary|Serum ALT in Males||Day 5|limited to males|||units per liter (U/L)||Standard Deviation|Mean
1214586|NCT00774163|Primary|Serum Alanine Aminotransferase (ALT) in Female Participants||Day 5|limited to females|||units per liter (U/L)||Standard Deviation|Mean
1214587|NCT00774163|Primary|Leukocyte Count on Day 5||Measured on day 5||||cells per cubic millimeter||Standard Deviation|Mean
1214588|NCT00774163|Primary|Mean Daily Temperature|Measured daily during 5 days of study product administration|5 days of study product administration||||Degrees Celcius||Standard Deviation|Mean
1214589|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|Days of observation||Number
1214590|NCT00774163|Secondary|Number of Subjects With at Least One PCR Positive Stool Specimen||Average of 36 day follow up period||||participants|||Number
1214591|NCT00774163|Primary|Number of Participants With a Positive Blood Culture for L. Reuteri|To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).|participants were followed for an average of 36 days|2:1 randomization Lactbacillus:placebo using a randomizatin table as specified in the protocol|||participants|||Number
1214592|NCT00774046|Secondary|Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 883 days|Subset of patients undergoing autologous stem cell transplant|||Days||Full Range|Median
1214593|NCT00774046|Secondary|Overall Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 817 days|Subset of patients undergoing autologous stem cell transplant|||Days||Full Range|Median
1214594|NCT00774046|Secondary|Numbers of Stem Cells Collected||1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.|||10^6 CD34+ cells/kg||Full Range|Median
1214595|NCT00774046|Secondary|Feasibility of Stem Cell Collection|Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg|1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.|||percentage of participants||95% Confidence Interval|Number
1214596|NCT00774046|Primary|Relapse-free Survival|Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.|Up to 2000 days||||Days||Inter-Quartile Range|Median
1214597|NCT00774046|Primary|Overall Survival||Up to 2000 days||||Days||Inter-Quartile Range|Median
1215174|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
1214598|NCT00774046|Primary|Response to Induction Chemotherapy (CR or PR)|Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made|Day 28-40||||percentage of participants||95% Confidence Interval|Number
1214599|NCT00773968|Secondary|Percentage of Participants Who Required Red Blood Cell Transfusions||Weeks 1 to 28|Safety population.|||percentage of participants|||Number
1214600|NCT00773968|Secondary|Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP|The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP: Weeks 1 to 16; EEP: Weeks 17 to 28|Per protocol population.|||percentage of participants|||Number
1214601|NCT00773968|Secondary|Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP||EEP: Weeks 17 to 28|Per protocol population.|||days||Full Range|Median
1214602|NCT00773968|Secondary|Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP||EEP: Weeks 17 to 28|Per protocol population.|||percentage of participants||95% Confidence Interval|Number
1214603|NCT00773968|Secondary|Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)|Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.|SVP: Week -4 to Week 0; EEP: Weeks 17 to 28|Per protocol population.|||g/dL||Standard Deviation|Mean
1214604|NCT00773968|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)|The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).|EEP: Weeks 17 to 28|Per protocol population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom the data for at least one follow-up variable were available and were without any major protocol violation.|||percentage of participants||95% Confidence Interval|Number
1214605|NCT00773955|Secondary|Duration of Response||From the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years|There were no confirmed responses qualifying for this endpoint.||||||
1214606|NCT00773955|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. Estimated using the method of Kaplan-Meier.~Per the RECIST criteria, progression is defined as at least a 20% increase in the sum of Longest Dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From registration to the earliest date documentation of disease progression, assessed up to 5 years|All 15 patients were analyzed for this endpoint.|||months||95% Confidence Interval|Median
1214607|NCT00773955|Secondary|Survival Time|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|All 15 patients were analyzed for this endpoint.|||months||95% Confidence Interval|Median
1214608|NCT00773955|Primary|Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)|"The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:~A Complete Response (CR) requires the disappearance of all target lesions~A Partial Response (PR) requires a >=30% decrease in the sum of the longest diameter of target lesions from baseline measurements."|During the first 6 courses of treatment|One patient discontinued therapy after one cycle of treatment due to persistent grade 1 thrombocytopenia. Therefore, fourteen patients were evaluable for the primary end point at the interim analysis.|||participants|||Number
1214609|NCT00773786|Secondary|Change From Baseline in Inspiratory Capacity at 1 Week|Change from baseline in Inspiratory Capacity (IC) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline).|baseline and 2 hours after dosing||||Liters||Standard Error|Mean
1214610|NCT00773786|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at 1 Week|Change from baseline in Forced Vital Capacity (FVC) after 1 week on Brovana or Placebo. (Change = 1 week - baseline)|baseline and 1 week||||Liters||Standard Error|Mean
1214611|NCT00773786|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week|Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)|baseline and 1 week||||Liters||Standard Error|Mean
1214625|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 36|Intent to Treat; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
1214612|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214613|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214614|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 24|ITT; Participants who entered the extension period|||percentage of participants||95% Confidence Interval|Number
1214615|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214616|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1214617|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1214626|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 24|Intent to Treat; Includes participants who entered the long term extension study|||units on a scale||Standard Deviation|Mean
1214618|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1214619|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long-term extension study|||units on a scale||Standard Deviation|Mean
1214620|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1214621|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension study|||units on a scale||Standard Deviation|Mean
1214622|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1214623|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
1214624|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 48|Intent to Treat; Includes participants who entered the long term extension study|||units on a scale||Standard Deviation|Mean
1214627|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 18|Intent to Treat; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
1214628|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 48|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
1214629|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 36|Intent to Treat; participants who entered into the long-term extension period|||percent change||Full Range|Median
1214630|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 24|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
1214631|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 18|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
1214632|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 48|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1214633|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 36|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1214634|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 24|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1214635|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 18|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
1214636|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 196|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.||||||
1214637|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 4 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1214733|NCT00773513|Secondary|Time to Non-Fatal and Fatal Stroke||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
1214638|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 3 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1214639|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 2 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1214640|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 18 Months|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1214641|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years|PASI-100 response is the percentage of participants who achieved at a 100% reduction (improvement) from baseline in PASI score of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1214642|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 196 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214643|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 148 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214644|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 100 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214645|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 76 of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214646|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214647|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214648|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214649|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214650|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1214651|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1220583|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|1 month after enrollment|Modified intention to treat analysis|||Participants|||Number
1214652|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; participants who entered the long-term extension study|||percentage of participants||95% Confidence Interval|Number
1214653|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; participants who entered the long-term extension study|||percentage of participants||95% Confidence Interval|Number
1214654|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks|Safety population: includes all participants who were treated with Apremilast|||participants|||Number
1214655|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase|For PASI-90 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-90 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI-90 was not defined or analyzed as there were too few such participants.||||||
1214656|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase|For PASI-75 responders in the placebo-controlled period Weeks 0-16, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-75 is achieved.|Weeks 0 to 16|Includes PASI-75 responders during the placebo controlled phase.|||weeks||Full Range|Median
1214657|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase|For PASI-50 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to 16|Includes PASI-50 responders during the placebo controlled phase|||weeks||Full Range|Median
1214658|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0-88; up to data cut off of 21 July 2011|Includes all participants who were treated with Apremilast|||participants|||Number
1214659|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16; up to data cut off of 21 July 2011|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)|||participants|||Number
1214959|NCT00772070|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.||Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Percentage of participants|||Number
1214660|NCT00773734|Secondary|Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)|Time to loss of response was modified to be 50% loss in the PASI response observed at the end of treatment for participants who achieved at least a PASI-50 at the end of treatment. This definition was changed since participants may have already lost their maximal PASI response prior to enrollment into the Observation Follow-up Phase. Included all participants that enrolled into the observational follow-up phase after the treatment phase.|Up to 4 weeks after the last dose|Participants who entered the observational follow-up phase and were PASI-50 responders at the beginning of the time interval.|||weeks||95% Confidence Interval|Median
1214661|NCT00773734|Secondary|Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study.|Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in participants who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study|Week 0 to 52|This endpoint was not summarized since the time of the maximal improvement is variable and the maximal improvement could occur in either the core phase or the extension phase||||||
1214662|NCT00773734|Secondary|Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52|Dose response relationship using percent reduction in PASI scores across dose groups at Week 52 compared to Week 0|Week 0 to Week 52|The dose-response relationship analysis was anticipated, however, since the extension study was optional and there was not placebo control, no formal testing of dose response was conducted||||||
1214663|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value..|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat|||units on a scale||Standard Deviation|Mean
1214664|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat;|||units on a scale||Standard Deviation|Mean
1214665|NCT00773734|Secondary|Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
1214666|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
1214721|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1214667|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
1214668|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
1214669|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 52|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
1214670|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 40|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
1214671|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 32|Includes participants who entered the extension study and had DLQI assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
1214672|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 52|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 52|Includes participants who entered the extension study and had BSA assessment at Week 52; Intent to Treat;|||percent change||Standard Deviation|Mean
1214673|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 40|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 40|Includes participants who entered the extension study and had BSA assessment at Week 40; Intent to Treat|||percent change||Standard Deviation|Mean
1214674|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 32|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 32|Includes participants who entered the extension study and had a BSA assessment at Week 32; Intent to Treat|||percent change||Standard Deviation|Mean
1214675|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 52|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
1214676|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 40|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
1214677|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 32|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
1214678|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 52|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 52|Includes participants who entered the extension study and had PASI assessment at Week 52; Intent to Treat;|||percent change||Standard Deviation|Mean
1214679|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 40|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 40|Includes participants who entered the extension study and had PASI assessment at Week 40; Intent to Treat;|||percent change||Standard Deviation|Mean
1214680|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 32|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 32|Includes participants who entered the extension study and had PASI assessment at Week 32; Intent to Treat|||percent change||Standard Deviation|Mean
1214681|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
1214734|NCT00773513|Secondary|Time to Non-Fatal and Fatal Myocardial Infarction||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
1214735|NCT00773513|Secondary|Time to All-Cause Mortality||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.|||years||95% Confidence Interval|Median
1214682|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less disease.|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat|||percentage of participants||95% Confidence Interval|Number
1214683|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat|||percentage of participants||95% Confidence Interval|Number
1214684|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-100 During the Extension Study|For PASI-100 responders in the extension study, time to achieve PASI-100 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-100 was achieved.|Week 0 to Extension Study|Time to achieve PASI-100 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
1214685|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-90 During the Extension Study|For PASI-90 responders in the extension study, time to achieve PASI-90 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-90 was achieved.|Week 0 to Extension study|Time to achieve PASI-90 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
1214686|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-50 During the Extension Study|For PASI-50 responders in the extension study, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to Week 52|Time to achieve PASI-50 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
1214687|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-75 During the Extension Study|For PASI-75 responders in the extension study, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-75 was achieved.|Week 0 to Week 52|Time to achieve PASI-75 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
1214688|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1214689|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1214690|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1215175|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
1214691|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1214692|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1214693|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1214694|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1214695|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1214696|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1214736|NCT00773513|Primary|Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.|||years||95% Confidence Interval|Median
1214737|NCT00773474|Secondary|Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).||18 months|20 evaluable subjects were analyzed for Clinical Benefit Rate (CR+PR+SD>180 days per RECIST criteria.|||participants|||Number
1214697|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1214698|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1214699|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
1214700|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (tmax) observed at Week 24 (Time to achieve steady-state Tmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||hours||Full Range|Median
1214701|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (Cmax) observed at Week 14 (Time to achieve steady-state Tmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||hours||Full Range|Median
1214702|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 24 (steady-state Cmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1214703|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 14 (steady-state Cmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1214704|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculate using the linear trapezoid rule.|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1214705|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculated using the linear trapezoid rule.|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1214706|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
1214738|NCT00773474|Secondary|Toxicity Profile of Lonafarib|To determine the toxicity profile of lonafarnib in this patient population.|18 months||||participants|||Number
1214739|NCT00773474|Secondary|Overall Response Rate|To determine overall response rate.|18 months|17 participants were evaluable for Overall Response Rate analysis using RECIST criteria.|||participants|||Number
1214707|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
1214708|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
1214709|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
1214710|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
1214711|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
1214712|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
1214713|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percent change||Standard Error|Least Squares Mean
1214722|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1214714|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 24|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.||||||
1214715|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 16|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See other pre-specified outcome measures.||||||
1214716|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
1214717|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Week 16|Intent to Treat; Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
1214718|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 24|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
1214719|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 16|The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||Percent change||Standard Error|Least Squares Mean
1214720|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase|For PASI-100 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-100 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI 100 was not defined or analyzed as there were too few participants.||||||
1215419|NCT00769860|Secondary|Heat Shock Protein 70 (HSP70) Levels in the Tissue|Biopsy taken from participants at baseline and month 4 visits. Measured change in HSP70 levels in the tissue.|Change from Baseline to Month 4||||ng/100ng myosin||Standard Deviation|Mean
1214723|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy..The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
1214724|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
1214725|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
1214726|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
1214727|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy.The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
1214728|NCT00773734|Primary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 and Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
1214729|NCT00773513|Secondary|Percentage of Participants With Thromboembolic Events||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
1214730|NCT00773513|Secondary|Percentage of Participants With Gastrointestinal Bleeding||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
1214743|NCT00773461|Secondary|Percentage of Participants With ACR20 Response by First Week of Onset|ACR 20 responses are summarized by first onset as a percentage of the total number of responders at week 24. The number of participants first achieving an ACR20 response at each time point is represented by treatment arm as a proportion of the total number of participants that had an ACR20 response at Week 24 using n as the denominator.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Percentage of Participants|||Number
1214744|NCT00773461|Secondary|Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24|HAQ-DI is a self-completed participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and 24 Weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1214745|NCT00773461|Secondary|Change in Hemoglobin From Baseline to Week 24|Levels of hemoglobin were determined in grams/liter (g/L)as a measure of anemia in participants|Baseline and 24 Weeks|ITT Population|||g/L||Standard Deviation|Mean
1214746|NCT00773461|Secondary|Mean Rheumatoid Factor at Baseline and Week 24|Rheumatoid factor (RF) is a disease characteristic and more than 85% of the participants studied were positive for the factor. These data are from patients who were RF positive. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL.|Baseline and 24 Weeks|ITT Population|||IU/mL||Standard Deviation|Mean
1214747|NCT00773461|Secondary|Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in health status.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1214748|NCT00773461|Secondary|Percentage of Participants With Low Disease Activity and in Clinical Remission|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, ESR and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants analyzed.|||Percentage of Participants|||Number
1214749|NCT00773461|Secondary|Change in ESR From Baseline to Week 24|The ESR was measured in mm/hour. A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population|||mm/hour||Standard Deviation|Mean
1214750|NCT00773461|Secondary|Change in C-Reactive Protein From Baseline to Week 24|The serum concentration of CRP an acute phase inflammatory marker, is measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population|||mg/dL||Standard Deviation|Mean
1214751|NCT00773461|Secondary|Change in Participant's Global Assessment of Pain From Baseline to Week 24|The participants assessed their pain on a 0 to 100 mm VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
1214752|NCT00773461|Secondary|Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity).|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
1214753|NCT00773461|Secondary|Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24|The participant’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
1214754|NCT00773461|Secondary|Change in Tender and Swollen Joint Counts From Baseline to Week 24|"68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.~66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66."|Baseline and Week 24|ITT Population|||Joints||Standard Deviation|Mean
1214755|NCT00773461|Secondary|Number of Participants Who Received Escape Therapy|Participants who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 could, if requested and deemed necessary by the investigator, receive escape therapy, comprising adjustment of the background DMARD dose and/or treatment with a different traditional DMARD.|24 Weeks|ITT Population|||Number of participants|||Number
1214756|NCT00773461|Secondary|Percentage of Participants With ACR50 and ACR70 Responses at Week 24|To achieve an ACR50 or ACR 70 response required at least a 50% or 70% improvement, compared with baseline in both TJC and SJC, as well as in 3 out of 5 additional ACR core set variables: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant’s assessment of pain, HAQ-DI and CRP. CRP was used primarily for the calculation of the ACR response; if missing, ESR was substituted.|Week 24|ITT Population|||Percentage of Participants|||Number
1214960|NCT00772070|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.||Baseline to Day 8 and Day 28 post-vaccination|Fold rise analysis was assessed in per-protocol population with valid serology data.|||Percentage of participants|||Number
1214757|NCT00773461|Primary|Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24|To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant’s assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward [LOCF]).|Week 24|ITT Population|||Percentage of Participants|||Number
1214758|NCT00773422|Secondary|Number of Cigarettes Smoked During the Ad-lib Period|Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study.|day 8||||cigarettes||Standard Error|Mean
1214759|NCT00773422|Primary|Latency to Initiate Ad-lib Smoking Session|Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes.|day 8||||minutes||Standard Error|Mean
1214760|NCT00773383|Secondary|Assessment of Potential Predictive and Prognostic Biomarkers.|Total IGF-I, free IGF I/II and other potential biomarkers present in serum. Further putative biomarker analyses in blood and tumor samples were planned in the protocol for exploratory assessment of correlation with clinical outcome. None of these were analyzed due to the termination of the trial.|Throughout study|Responders and non-responders||||||
1214761|NCT00773383|Secondary|Population Pharmacokinetics of R1507 and Tarceva|Population PK of R1507 and erlotinib were planned but not analyzed due to the termination of the trial.|Throughout study|Population PK of R1507 and erlotinib||||||
1214762|NCT00773383|Secondary|Electrocardiogram (ECG)|12 lead ECG is required at baseline and will be measured during the trial as clinically indicated at the discretion of the investigators. For each reading, QTcF value will be calculated as the QT value (seconds) divided by the cube root of the RR interval in seconds (Fridericia correction). A listing will be generated showing, for each patient, the visits at which ECGs were taken and the results (normal or abnormal, as well as any comments provided).|baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks)|Safety Population|||ms (millisecond)||Standard Deviation|Mean
1214763|NCT00773383|Secondary|Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing|"Number of participants who tested positive for Human anti-human antibody (HAHA) testing for immunogenicity.~To determine HAHA specificity, screened positive samples were tested in a confirmatory assay in the presence of 10 ug/mL R1507. Samples with > 19.7% inhibition were considered true positives, whereas those with < 19.7% inhibition were considered to be false positives."|prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks)|Safety Population|||participants|||Number
1214764|NCT00773383|Secondary|Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.~Not posted; it will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|Within 7 days of starting treatment (baseline visit)|Female patients of childbearing potential||||||
1214765|NCT00773383|Secondary|Hemoglobin A1c (HbA1c)|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.~Data will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|screening|Safety Population||||||
1214766|NCT00773383|Secondary|Fasting Glucose, Highest Post-Baseline Value|A fasting glucose was required at baseline, and random non-fasting glucose testing was performed weekly for the first 6 weeks followed by day 1 of each 3 week treatment phase. The number of participants with the highest post-baseline fasting glucose level at any time point post baseline relative to the participant’s baseline glucose level is reported.|Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks)|Safety Population: based on the total number of participants n = 34|||participants|||Number
1214767|NCT00773383|Secondary|Baseline Electrocardiogram (ECG)|"Standard safety monitoring includes baseline Electrocardiogram (ECG).~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|baseline within 28 days of starting treatment (screening visit).|Safety Population||||||
1214768|NCT00773383|Secondary|Duration of Objective Response|This is defined similarly for complete and partial responders. Complete response or partial response lasts from the date the complete response or partial response was first recorded to the date on which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken|All Treated Population||||||
1214769|NCT00773383|Secondary|Time to Progressive Disease (PD)|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.|All Treated Population||||||
1214770|NCT00773383|Secondary|Time to Best Response|"This is defined as time from the start of therapy to the date of first CR or PR.~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population||||||
1214771|NCT00773383|Secondary|Participants Achieving Objective Response|"Objective response is defined as a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST)criteria.~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population||||||
1214772|NCT00773383|Secondary|Duration of Overall Survival|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of treatment to death; up to the time that all participants ended treatment|All Treated Population||||||
1214773|NCT00773383|Primary|Percentage of Participants With Progression Free Survival (PFS)|The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.|12 weeks|All Treated Population|||Percentage of participants|||Number
1214774|NCT00773370|Secondary|Stroke Impact Scale (SIS)|The SIS Version 3.0 is a self report scale widely used to assess health status after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above.|||units on a scale||Standard Error|Mean
1214775|NCT00773370|Secondary|Short Physical Performance Battery (SPPB)|The SPPB, which is extensively used in stroke studies, includes three components and a composite score. Components include gait speed, a repeated chair stand, and a standing balance test. Scores for gait speed, chair stand, and total balance are calculated and then summed for the total score. Each component can range from 0-4 points, thus the maximum composite score can range from 0-12 points, with 0 reflecting the lowest functioning while a score of 12 indicates the subject reached the maximum measured competency in all three domains. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
1214776|NCT00773370|Secondary|Balance as Measured by the Berg Balance Scale (BBS)|The Berg is a widely used test for assessing balance and to predict fall risk in the elderly. It has been validated with patients post stroke. The Berg consists of 14 items, each graded on a scale of 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the fall risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
1214777|NCT00773370|Primary|6 Minute Walk Test (6MWT)|Total distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||meters||Standard Error|Mean
1214778|NCT00773279|Secondary|Hypoglycaemic Episodes, Number of Events Per Subject Day||Weeks 0-12 (first treatment) and 12-24 (second treatment)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).|||events per subject-day|||Number
1214779|NCT00773279|Secondary|Number of Adverse Device Effects|Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.|From randomisation (week 0) and until 7 days after Week 24 (Visit 16)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||events|||Number
1214780|NCT00773279|Secondary|Number of Hypoglycaemic Episodes|Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.|Weeks 0-12 (first treatment) and 12-24 (second treatment)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||episodes|||Number
1214781|NCT00773279|Secondary|Clinical Technical Complaints (CTCs)|A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.|Weeks 0-24 (whole trial period)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||CTCs|||Number
1215145|NCT00771901|Primary|Body Composition|Fat mass (%)|Baseline and four weeks||||percentage||Standard Deviation|Mean
1214782|NCT00773279|Secondary|Score for Treatment Impact Measure for Diabetes|Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.|Week 24|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any TRIM-D available results in PDS290 and FlexPen® treatment groups, respectively.|||scores on a scale||Standard Deviation|Mean
1214783|NCT00773279|Secondary|Summary Score for Treatment Satisfaction|Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.|Week 24|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available ITSQ results in PDS290 and FlexPen® treatment groups, respectively.|||scores on a scale||Standard Deviation|Mean
1214784|NCT00773279|Secondary|Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use|Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)|Week 24|ITT population. Some subjects did not have any available Niskanen Comparative Device Questionnaire results.|||percentage of participants|||Number
1214785|NCT00773279|Primary|HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®||Week 12 of each treatment sequence|Intention-to-treat (ITT) population comprising all randomised subjects and with data on HbA1c. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects dropped out during either treatment sequence.|||percentage (%) of total haemoglobin||Standard Deviation|Mean
1214786|NCT00773253|Primary|Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale|Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).|48 weeks|All participants that completed all phases of the study|||percent change in units on the scale||Standard Deviation|Mean
1214787|NCT00773253|Primary|Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)||pre-injection, week 16, 20, 36, and 40|||||||
1214788|NCT00773175|Secondary|Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge|Participants were discharged from the ED to home or the hospital to continue hydration therapy.|from randomization up to approximately 98 hours|ITT Population. Only those participants who were re-hospitalized or had an Emergency Department visit after initial discharge to home were analyzed.|||Participants|||Count of Participants
1214789|NCT00773175|Secondary|Number of Participants Discharged From the ED to Home or the Hospital|Participants were discharged from the ED to home or the hospital to continue hydration therapy.|up to approximately 26 hours|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
1214790|NCT00773175|Secondary|Number of Participants for Which the Indicated Gauge for Infusion Device Was Used|Data are reported for the gauge of infusion device used.|average of approximately 3 minutes|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
1214791|NCT00773175|Secondary|Number of Participants for Which the Indicated Type of Infusion Device Was Used|Data are reported for the type of infusion device used.|average of approximately 3 minutes|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
1214792|NCT00773175|Secondary|Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration|Data are reported for the number of needle stick attempts needed to initiate fluid administration.|average of approximately 3 minutes|ITT Population|||Participants|||Count of Participants
1214793|NCT00773175|Secondary|Time From Randomization to the First Drop of Fluid Infusion|Data are reported for the time from randomization to the start of fluid infusion for all randomized participants.|up to approximately 110 and 220 minutes for the SC and IV arms, respectively|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||minutes||95% Confidence Interval|Median
1214794|NCT00773175|Secondary|Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge|Data are reported from the start of infusion to the time of ED discharge.|up to approximately 26 hours|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants with available data were analyzed.|||hours||Standard Deviation|Mean
1214795|NCT00773175|Secondary|Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement|Data were collected for the number of additional personnel involved in needle placement.|average of approximately 3 minutes|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
1214796|NCT00773175|Secondary|Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training|Data were collected for the level of staff training for the person who performed the needle placement.|average of approximately 3 minutes|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
1214797|NCT00773175|Secondary|Number of Participants Experiencing Reductions in Flow Rate|In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
1214808|NCT00773175|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure|Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.|Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants with available data were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1214798|NCT00773175|Secondary|Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration|In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
1214799|NCT00773175|Secondary|Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire|"A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Do you believe the method of therapy was successful in your child's rehydration?; Question 2: Have you or your child ever previously had IV fluids (for SC Group) / SC fluids (for IV Group)?; Question 3: If the response to Question 2 was yes, how does this compare to prior experience with IV (for SC Group) / SC (for IV Group)?; Question 4: Should your child(ren) need rehydration treatment in the future, would you opt for this procedure?; Question 5: Should you need rehydration treatment in the future, would you opt for this procedure?; Question 6: What is your global satisfaction with the study procedure?"|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|"ITT Population. Only participants with a response of Yes to Question 2 contributed responses for Question 3."|||Participants|||Count of Participants
1214800|NCT00773175|Secondary|Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy?|A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV).|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
1214801|NCT00773175|Secondary|Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire|A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Was the participant successfully hydrated using the randomized route of administration?; Question 2: Overall, was the procedure of fluid infusion easy to perform?; Question 3: Were there any unacceptable side effects from the therapy?; Question 4: Would you consider using this hydration therapy for this indication in the future?|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
1214802|NCT00773175|Secondary|Number of Participants With the Indicated Type of Rescue Route Therapy Administered|Participants for whom parenteral access by the randomized route of administration could not be achieved after a reasonable number of attempts and for whom the investigator had deemed the access by that route a failure were expected to receive fluid administration by other means, designated as “rescue route” for the purpose of this study. This rescue route may have included venous cut-down, central venous line, interosseous access, etc., and for those participants initially randomly assigned to IV fluid administration, SC fluid administration by hylenex-facilitated infusion.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
1214803|NCT00773175|Secondary|Percent Change From Baseline in Body Weight|Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) * 100.|Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants contributing data at the indicated time point were assessed.|||percent change||Standard Deviation|Mean
1214804|NCT00773175|Secondary|Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion|Hydration status was assessed clinically using the Gorelick 10-item scale: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate, and capillary refill time at the fingertip. Scores ranged from 0 (less severe impairment) to 10 (more severe impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants contributing data at the indicated time point were assessed.|||score on a scale||Standard Deviation|Mean
1214805|NCT00773175|Secondary|Infusion Duration During the Initial Infusion|Infusion duration was assessed as a measure of the time required to complete the initial infusion of 20 mL/kg.|first hour of infusion|ITT Population|||hours||Standard Deviation|Mean
1214806|NCT00773175|Secondary|Number of Participants With the Indicated Type of Fluid Administered|Data are reported for the initial fluid administered.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
1214807|NCT00773175|Secondary|Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score|The infusion site was assessed for pain at two time points: after placement of the infusion device but before fluid infusion and at the end of infusion. Pain was recorded using the FLACC pain scale for children less than 3 years of age. Scores on the scale ranged from 0 (no hurt) to 10 (hurt worst).|Before infusion (Baseline); after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants with available data were analyzed.|||score on a scale||Standard Deviation|Mean
1215146|NCT00771875|Secondary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)||1 year||||participants|||Number
1215147|NCT00771875|Secondary|Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy||90 days||||participants|||Number
1215148|NCT00771875|Secondary|Incidence of Death||90 days||||participants|||Number
1214809|NCT00773175|Secondary|Mean Change From Baseline in Respiratory Rate|Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.|Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants with available data were analyzed.|||breaths per minute||Standard Deviation|Mean
1214810|NCT00773175|Secondary|Mean Change From Baseline in Heart Rate|Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.|Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants with available data were analyzed.|||beats per minute||Standard Deviation|Mean
1214811|NCT00773175|Secondary|Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration|Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion. Not Rel Dehy = Abnormal, Not Related to Dehydration; Rel Dehy = Abnormal, Related to Dehydration. The investigator assessed findings as abnormal.|Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
1214812|NCT00773175|Secondary|Number of Participants With the Indicated Type of Adverse Events|Adverse events (AEs) are defined as any untoward medical occurrence in a participant administered a product, which did not necessarily have a causal relationship with the treatment. Treatment-emergent adverse events (TEAEs) are defined as those events that occurred on or after the first injection device insertion attempt.|up to 7 days after hospital discharge|Safety Population: all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)|||Participants|||Count of Participants
1214813|NCT00773175|Secondary|Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration|The number of participants administered at least 20 mL total volume was assessed.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
1214814|NCT00773175|Secondary|Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration|The maximum flow rate was averaged over any 60-minute period of time.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
1214815|NCT00773175|Secondary|Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants|The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.|||milliliters per kilogram per hour||Standard Deviation|Mean
1214816|NCT00773175|Secondary|Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants|The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.|||milliliters per kilogram per hour||Standard Deviation|Mean
1214817|NCT00773175|Secondary|Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants|The mean flow rate was averaged over any 60-minute period of time.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.|||milliliters per kilogram per hour||Standard Deviation|Mean
1214818|NCT00773175|Secondary|Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants|The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.|||milliliters per hour||Standard Deviation|Mean
1214819|NCT00773175|Secondary|Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants|The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.|||milliliters per hour||Standard Deviation|Mean
1214820|NCT00773175|Secondary|Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants|The mean flow rate was averaged over any 60-minute period of time.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||milliliters per hour||Standard Deviation|Mean
1214821|NCT00773175|Secondary|Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Achieving > 200 mL|It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term “anatomical site” was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Randomized Participants. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.||||||
1214822|NCT00773175|Secondary|Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Achieving > 200 mL|It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term “anatomical site” was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Randomized Population. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were to be analyzed.||||||
1214823|NCT00773175|Secondary|Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Achieving > 200 mL|It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term “anatomical site” was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the Food and Drug Administration (FDA) removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Randomized Population: all participants who were assigned a patient randomization number||||||
1214824|NCT00773175|Secondary|Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants|It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term “anatomical site” was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||milliliters||Standard Deviation|Mean
1214825|NCT00773175|Primary|Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants|It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term “anatomical site” was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.|||milliliters||Standard Deviation|Mean
1214826|NCT00773175|Primary|Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants|It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term “anatomical site” was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.|||milliliters||Standard Deviation|Mean
1214941|NCT00772447|Primary|Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)|Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||percentage||Standard Deviation|Mean
1214827|NCT00773175|Primary|Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants|It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term “anatomical site” was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Intent-to-Treat (ITT) Population: all randomly assigned participants for whom the treatment was attempted, (i.e., infusion device placement was initiated)|||milliliters||Standard Deviation|Mean
1214828|NCT00773136|Primary|Efficacy of Bimatoprost in Lengthening of Eyelashes|Eyelash growth after application of bimatoprost vs control (split face study).|4.5 months (6 weeks of drug application and 3 months after discontinuing)||||mm||Standard Deviation|Mean
1214829|NCT00773097|Secondary|Number of Participants With Adverse Events Associated With the Study Agent|Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.|54 weeks||||participants|||Number
1214830|NCT00773097|Secondary|Number of Participants With Autoimmune Response to Muc-1 Vaccine|Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.|52 weeks||||participants|||Number
1214831|NCT00773097|Primary|Number of Participants With Anti Muc-1 Antibody|Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.|52 weeks|Of the 46 subjects who consented to participate, 6 did not receive vaccine: 4 had abnormal screening laboratory test, 1 did not meet criteria for an advanced adenoma, and 1 declined to participate|||participants|||Number
1214832|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
1214833|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
1214834|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
1214835|NCT00772967|Primary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
1214836|NCT00772954|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.||Day 0 up to 70 days post first vaccination|Safety assessments were on the safety population.|||Participants|||Number
1214837|NCT00772941|Secondary|Number of Participants With Continuous Abstinence Situation by 52 Weeks.|Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.|52 weeks|No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events.|||participants|||Number
1214838|NCT00772941|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of unlisted treatment related adverse events.|||events|||Number
1214839|NCT00772941|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of treatment related adverse events.|||participants|||Number
1214840|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842.|||participants|||Number
1214841|NCT00772941|Primary|Risk Factors for the Proportion of Responders – Prolonged Administration After 12 Weeks.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598.|||participants|||Number
1214842|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827.|||participants|||Number
1214843|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.|Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700.|||participants|||Number
1214844|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Therapies.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1214845|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Drugs.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1214846|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1214847|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Age.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1214848|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Gender.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1214849|NCT00772928|Other Pre-specified|Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™|Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.|0-3 days post- vaccination and entire study period|Analysis was on all enrolled and vaccinated subjects, intend-to-treat population.|||Percentage of Participants|||Number
1214850|NCT00772928|Primary|Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.|60 Days Post-dose 3|Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population|||All Units||95% Confidence Interval|Geometric Mean
1214851|NCT00772928|Primary|Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.|28 to 48 days post-3rd vaccination|Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1214852|NCT00772915|Secondary|Adverse Events||Duration on treatment (up to 18 cycles from registration)|||||||
1214853|NCT00772915|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.~Progression was defined as any one or more of the following:An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|Time from registration to progression or death (up to 3 years)|||||||
1214854|NCT00772915|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 3 years from randomization. The median OS with 95% CI was estimated using the Kaplan Meier method|Time from registration to death (up to 3 years)|||||||
1214855|NCT00772915|Secondary|Overall Response Rate|"Response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Up to 18 cycles from registration|||||||
1214856|NCT00772915|Primary|Progression-free Survival Rate at 12 Months|PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of registration.|12 months from registration||||participants|||Number
1214857|NCT00772889|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 21-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1214858|NCT00772889|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort . The cohort included all evaluable subjects for whom data concerning immunogenicity at were available.|||fold increase||95% Confidence Interval|Mean
1214859|NCT00772889|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
1214860|NCT00772889|Secondary|The Number of Subjects Seroprotected by HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
1214861|NCT00772889|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
1214862|NCT00772889|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||titer||95% Confidence Interval|Geometric Mean
1214863|NCT00772889|Secondary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-364.|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1214879|NCT00772707|Primary|Comfort Ratings at 30 Days|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|30 days|5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).|||Percentage of Participants|||Number
1214864|NCT00772889|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1214865|NCT00772889|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1214866|NCT00772889|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1214867|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1214868|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1214869|NCT00772889|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1214870|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1214871|NCT00772889|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1214872|NCT00772889|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1214873|NCT00772772|Secondary|1, 25-OH Vitamin D||after 8 weeks of vitamin D therapy|||||||
1214874|NCT00772772|Secondary|25-hydroxy Vitamin D (25-OH Vitamin D)|25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly.|after 8 weeks of vitamin D therapy|Patients with chronic kidney disease had 25-OH vitamin D levels measured at baseline and after 8 weeks of Vitamin D3 therapy. Analysis was per protocol.|||ng/ml||Standard Error|Mean
1214875|NCT00772772|Secondary|Nuclear Magnetic Resonance (NMR) Lipoprotein Profile||after 8 weeks of vitamin D therapy|||||||
1214876|NCT00772772|Secondary|Intestinal Permeability||after 8 weeks of vitamin D therapy|||||||
1214877|NCT00772772|Secondary|Blood Pressure||after 8 weeks of vitamin D therapy|||||||
1214878|NCT00772772|Primary|Change in Endotoxin Activity|Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).|baseline and 8 weeks|Per protocol. Result is expressed as change in endotoxin activity with therapy|||EA units||Standard Deviation|Mean
1215149|NCT00771875|Secondary|Mean Serum Creatinine|Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation|7, 14, 28, 60, 90 days and 1 year post therapy initiation||||mg/dL||Standard Deviation|Mean
1214880|NCT00772707|Primary|Comfort Ratings at Baseline|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|Baseline (Day 0)|6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).|||Percentage of Participants|||Number
1214881|NCT00772668|Secondary|Rate of Toxicity in Study Participants|Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants|Up to 5 years||||participants|||Number
1214882|NCT00772668|Secondary|Overall Survival (OS)|Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact.|Up to 5 years||||months|||Number
1214883|NCT00772668|Secondary|Progression-free Survival (PFS)|Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact.|Up to 5 years||||months|||Number
1214884|NCT00772668|Primary|Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL)|"Rate of overall response (CR, CRu, PR) to protocol therapy according to International Workshop Criteria (IWC):~Complete Response (CR) includes complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL;~Complete Response Unconfirmed (CRu) includes above CR criteria but a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product of the perpendicular diameters (SPD), or indeterminate bone marrow;~Partial Response (PR) includes >= 50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen."|Post cycles 2,4,6,8 and then every 3 months, about 2 years|A minimum enrollment of 30 participants was required for this outcome measure. Due this minimum requirement not being met, and the early termination of the study due to lack of funding, the data for this outcome measure were not analyzed.||||||
1214885|NCT00772629|Primary|Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.|Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.|Day 28 post-vaccination|SBA-BR to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Participants|||Number
1214886|NCT00772603|Secondary|Seizure Free Rate, ITT, (M)|Percent of patients seizure-free during Maintenance, Intent-to-Treat population|At the end of 12 weeks (Maintenance Period)|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.|||percentage of patients|||Number
1214887|NCT00772603|Secondary|Seizure-Free Rates, ITT|Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of patients|||Number
1214888|NCT00772603|Secondary|Responder Rate, ITT|Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of patients|||Number
1214889|NCT00772603|Secondary|PCH(M)- ITT|Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population|Change at 12 weeks (Maintenance Period) compared to Baseline|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.|||percentage of change||95% Confidence Interval|Median
1214890|NCT00772603|Primary|PCH(T), ITT|Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.|Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of change||Full Range|Median
1214891|NCT00772590|Primary|Mean Change From Baseline CD4+ Cell Count|Comparison of normalised mean change from baseline CD4+ cell count|24 weeks|intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.|||Cells/microlitre||Standard Deviation|Mean
1214892|NCT00772577|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP)|To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1214918|NCT00772538|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214893|NCT00772577|Secondary|Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)|To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).|||Percentage of patients|||Number
1214894|NCT00772577|Secondary|Percentage of Patients Achieving Blood Pressure Control During 8 Weeks|The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).|||Percentage of patients|||Number
1214895|NCT00772577|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1214896|NCT00772577|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1214897|NCT00772538|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.417 (NCT00776984) and the Present 205.416 (NCT00772538)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).~This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)|||percentage of participants|||Number
1214898|NCT00772538|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Puffs||Standard Error|Mean
1214899|NCT00772538|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Days||Standard Error|Mean
1214900|NCT00772538|Secondary|ACQ at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1214901|NCT00772538|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1214902|NCT00772538|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1214903|NCT00772538|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1214904|NCT00772538|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
1214905|NCT00772538|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
1215150|NCT00771875|Secondary|Renal Allograft Survival||1 year after rejection treatment||||participants|||Number
1214906|NCT00772538|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As <50percent (10 of 222 patients in the placebo group and 8 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
1214907|NCT00772538|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
1214908|NCT00772538|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
1214909|NCT00772538|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS..|||Participants|||Number
1214910|NCT00772538|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS..|||Participants|||Number
1214911|NCT00772538|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As <50percent (68 of 222 patients in the placebo group and 53 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
1214912|NCT00772538|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Percent||Standard Error|Mean
1214913|NCT00772538|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
1214914|NCT00772538|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
1214915|NCT00772538|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
1214916|NCT00772538|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
1214917|NCT00772538|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214942|NCT00772382|Secondary|The Change in Serum Phosphorus From Baseline to Week 52||52 weeks|Intent-to-treat (ITT) with last observation carried forward (LOCF). (ITT population included all enrolled subjects who took at least one dose of study medication and had at least one post-enrollment efficacy value after the start of study medication.)|||mg/dL||95% Confidence Interval|Mean
1214919|NCT00772538|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214920|NCT00772538|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214921|NCT00772538|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214922|NCT00772538|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214923|NCT00772538|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214924|NCT00772538|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214925|NCT00772538|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214926|NCT00772538|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214927|NCT00772538|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||Days||Inter-Quartile Range|Median
1214928|NCT00772538|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1214929|NCT00772538|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.|||Liter||Standard Error|Mean
1214930|NCT00772447|Secondary|Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC|This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 48 patients indentified staphylococcus aureus infection both in daptomycin group and in comparator group.|||Percentage of patients|||Number
1214931|NCT00772447|Secondary|Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC|This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 33 patients indentified MSSA infection in daptomycin group and 37 patients indentified with MSSA in comparator group.|||Percentage of patients|||Number
1214932|NCT00772447|Secondary|Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)|This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups.|baseline and TOC, for up to 4 weeks|There were 14 patients indentified MRSA infection in daptomycin group and 10 patients indentified with MRSA in comparator group.|||Percentage of patients|||Number
1214933|NCT00772447|Secondary|Microbiological Response at EOT(End of Therapy)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline.|baseline and EOT, for up to 2 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 86 strains isolated from 81 patients in daptomycin arm and 88 strains from 81 patients in comparator arm who met the criteria of ME population at EOT visit.|||Percentage of strains|Participants||Number
1214934|NCT00772447|Secondary|Microbiological Response at TOC(Test of Cure)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline.|baseline and TOC, for up to 4 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 83 strains isolated from ME population of daptomycin arm(78 patients) and 86 strains from ME population in comparator arm(79 patients).|||Percentage of strains|Participants||Number
1214935|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and EOT(end of therapy), for up to 2 weeks|There were 110 patients in daptomycin arm and 103 patients in comparator arm who both completed EOT visit and met the criteria of CE population|||Percentage of patients|||Number
1214936|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and TOC, for up to 4 weeks|There were 107 patients in daptomycin arm and 101 patients in comparator arm meeting the criteria of CE population and completed TOC visit.|||percentage of patients|||Number
1214937|NCT00772447|Primary|Shift in ECG|percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had both measurements at baseline and TOC visit and those who got normal ECG resluts at baseline were included in the summary. Change=TOC visit-baseline|||percentage of patients|||Number
1214938|NCT00772447|Primary|Change in Urine pH||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements were included in the summary of a specific parameter at a specific time point. Change = TOC visit - baseline|||pH||Standard Deviation|Mean
1214939|NCT00772447|Primary|Change in Serum Total Creatine Phosphokinase (CPK)||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||IU/L||Standard Deviation|Mean
1214940|NCT00772447|Primary|Change in Creatinine Clearance||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||ml/min||Standard Deviation|Mean
1214943|NCT00772382|Primary|Number of Adverse Events (AE)||52 weeks||||participants|||Number
1215151|NCT00771875|Secondary|Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy||Day 1||||participants|||Number
1214944|NCT00772369|Primary|Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.|"SAE: any untoward medical occurrence with the following outcomes:~death,~a life-threatening adverse drug experience (as confirmed by the investigators),~inpatient hospitalization or prolongation of existing hospitalization,~a persistent or significant disability/incapacity, or~a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)"|6 Months post 4th dose vaccination|Response to questionnaire that were confirmed by the primary care physician’s office were analyzed, Primary Analysis Population. Unconfirmed safety data form 29 participants were excluded from the primary analysis.|||Participants|||Number
1214945|NCT00772369|Primary|Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series|"Positive response is a 'Yes' to any of the following questions:~Has your child been admitted to a hospital?~Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician’s office?~Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?~Has your child been diagnosed by a physician as having:~Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?"|6 months post 4th dose vaccination|Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.|||Particpants|||Number
1214946|NCT00772304|Secondary|Taste and Aftertaste of Medication||5 min, 45 min.|||||||
1214947|NCT00772304|Primary|Product Preference Questionnaire for Immediate Taste|Using a set of coded responses, subjects evaluated product preference in regards to immediate taste|5 min post-dose||||Percentage of participants|||Number
1214948|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|14 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
1214949|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|7 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
1214950|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|1 day|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
1214951|NCT00772148|Primary|Pharmacokinetics (AUC0-24) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameter (AUC, 0 to 24 hours post dose) was evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)|||ng/mL*hr||Standard Deviation|Mean
1214952|NCT00772148|Secondary|Number of Participants Who Died Within the 360 Days.|Number of patients who died was compared between the two groups during the study.|360 days||||participants|||Number
1214953|NCT00772148|Primary|Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)|||ng/mL||Standard Deviation|Mean
1214954|NCT00772109|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to 7 Days post vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population|||Participants|||Number
1214955|NCT00772109|Secondary|Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.~Seroprotection was defined as a HAI antibody titer ≥ 1:40."|Before and 28 Days post-vaccination|4-Fold increase in antibody levels were analyzed in h per-protocol population|||Percentage of Participants|||Number
1214956|NCT00772109|Primary|Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination."|28 Days post-vaccination|Seroprotection was analyzed in the per-protocol population|||Percentage of Participants|||Number
1214957|NCT00772109|Primary|Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines|The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay|Baseline (Day 0) and 28 Days post-vaccination|Geometric Mean Titers (GMTs) were analyzed in the per-protocol population|||Titer||95% Confidence Interval|Geometric Mean
1215420|NCT00769860|Primary|Count of Adverse Events Reported|Measure reflects the total number of adverse events reported during course of the study.|Month 12||||adverse events reported|||Number
1214961|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 Months||||units on a scale||Standard Deviation|Mean
1214962|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1214963|NCT00772031|Secondary|Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|baseline and 6 months post randomization|per protocol|||units on a scale||Standard Deviation|Mean
1214964|NCT00772031|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months|MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability).|Baseline and 6 months|per protocol|||units on a scale||Standard Deviation|Mean
1214965|NCT00772031|Secondary|Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months|Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21).|Baseline and 6 months|The number who completed the Beck's Depression Inventory at baseline and three months|||units on a scale||Standard Deviation|Mean
1214966|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days||6 months|All participants with the opportunity for 6-month follow-up. Due to early study termination some participants were randomized and did not have the opportunity to be followed for six months|||participants|||Number
1214967|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days||6 months post randomization|All subjects randomized with opportunity for 6 month followup. Due to early study termination those who did not have opportunity for 6 month followup at time of study closure were excluded. All lost to followups were counted as failure|||participants|||Number
1214968|NCT00772031|Primary|Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline|(Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).|Baseline (pre-randomization), months 5 and 6 post randomization|ITT to the extent diary information was available. Available defined as all subjects with 12 or more diary entries between 16 and 24 weeks. Multiple imputation used on all randomized subjects as a sensitivity analysis on the primary outcome.|||Moderate to severe headache days||Standard Deviation|Mean
1214969|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1214970|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1214971|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1214972|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214973|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214974|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214975|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214976|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214977|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214978|NCT00772005|Secondary|Change From Baseline to Week 24 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
1214979|NCT00772005|Secondary|Change From Baseline to Week 12 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
1214980|NCT00772005|Secondary|Change From Baseline to Endpoint in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
1215152|NCT00771875|Primary|Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection|"Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment.~Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal."|1 year||||participants|||Number
1214981|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214982|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214983|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1214984|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1214985|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.|||percentage of participants|||Number
1214986|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1214987|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1214988|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1214989|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1219141|NCT00740714|Secondary|Adverse Experiences: Hypertension|Number of participants with hypertension|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1214990|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1214991|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1214992|NCT00772005|Secondary|Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1214993|NCT00772005|Secondary|Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1214994|NCT00772005|Secondary|Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1214995|NCT00772005|Secondary|Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1214996|NCT00772005|Secondary|Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1214997|NCT00772005|Secondary|Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215153|NCT00771849|Secondary|Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.||28 days post-vaccination|SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.|||Participants|||Number
1215154|NCT00771849|Primary|Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.||Day 0 (before) and 28 days post-vaccination|SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1214998|NCT00772005|Secondary|Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1214999|NCT00772005|Secondary|Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215000|NCT00772005|Secondary|Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215001|NCT00772005|Secondary|Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215002|NCT00772005|Secondary|Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215003|NCT00772005|Secondary|Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215004|NCT00772005|Secondary|Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215005|NCT00772005|Secondary|Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215155|NCT00771810|Secondary|Rescue Treatment for Hematopoiesis and Mucositis|"Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:~Transfusions~Filgrastim or Pegfilgrastim~Erythropoietin~Palifermin"|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1215006|NCT00772005|Secondary|Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215007|NCT00772005|Secondary|Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215008|NCT00772005|Secondary|Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215009|NCT00772005|Secondary|Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215010|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215011|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215012|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215013|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215156|NCT00771810|Secondary|Alopecia|Number of subjects with a treatment emergent adverse event of alopecia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1215157|NCT00771810|Secondary|Mucositis|Number of subjects with a treatment emergent adverse event of mucositis|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1215014|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215015|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215016|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215017|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215018|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215019|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 24, positive value represents worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215020|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 20, positive value represents worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215021|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 16, positive value represents worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215158|NCT00771810|Secondary|Anemia|Number of subjects with a treatment emergent adverse event of anemia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1215159|NCT00771810|Secondary|Neutropenia|Number of subjects with a treatment emergent adverse event of neutropenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1215022|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 12, positive value represents worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215023|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 8, positive value represents worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215024|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 4, positive value represents worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215025|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 2, positive value represents worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215026|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 1, positive value represents worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215027|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to endpoint, positive value represents worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1215028|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
1215029|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
1215030|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to endpoint with positive values demonstrating improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
1215031|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minus errors||Standard Error|Least Squares Mean
1215032|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minus errors||Standard Error|Least Squares Mean
1215033|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to endpoint and a positive value represents improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minue errors||Standard Error|Least Squares Mean
1215034|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
1215035|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
1215036|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to endpoint with positive values representing improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
1215037|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 24, with positive score showing improvement."|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215038|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 12, with positive score showing improvement."|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215160|NCT00771810|Secondary|Lymphopenia as Determined by Lymphocyte Count|Number of subjects with a treatment emergent adverse event of lymphopenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1215161|NCT00771810|Secondary|Chemotherapy Dose Intensity and Dose Density|Mean percentage of cycles where projected (target) chemotherapy dose was maintained|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
1215039|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to endpoint, with positive score showing improvement."|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215040|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215041|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215042|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215043|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to endpoint in the overall score with positive values signifying improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215044|NCT00772005|Secondary|Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215045|NCT00772005|Secondary|Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 22|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215046|NCT00772005|Secondary|Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215162|NCT00771810|Secondary|Treatment Cycles With Platelets Counts Below 25,000/mm3|Mean percentage of treatment cycles where platelets counts were below 25,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
1215047|NCT00772005|Secondary|Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 18|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215048|NCT00772005|Secondary|Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215049|NCT00772005|Secondary|Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 14|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215050|NCT00772005|Secondary|Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215051|NCT00772005|Secondary|Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 10|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215052|NCT00772005|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215053|NCT00772005|Secondary|Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 6|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215054|NCT00772005|Secondary|Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215163|NCT00771810|Secondary|Subjects With Platelet Counts Below 50,000/mm3|Number of subjects who experienced a platelet count below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1215164|NCT00771810|Primary|Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3|Mean percentage of cycles with platelet counts below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
1215055|NCT00772005|Secondary|Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215056|NCT00772005|Secondary|Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215057|NCT00772005|Secondary|Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to endpoint in the CGI-S rating. A negative value indicates improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215058|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215059|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215060|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215061|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215062|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215165|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Bothersome|"The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = not at all to 5=a very great deal."|Day 10|Intent-to Treat population.|||percent of participants|||Number
1225767|NCT00697593|Primary|Hematology - Neutrophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
1215063|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215064|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215065|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215066|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) score indicates worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215067|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215068|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215069|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215070|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215166|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming|The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = “not at all” to 5=“a very great deal.”|Day 10|Intent-to Treat population.|||percent of participants|||Number
1215071|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215072|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215073|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215074|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215075|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenic patients. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms/posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215076|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215077|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215078|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215167|NCT00771758|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.|||percenatage of participants|||Number
1215079|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215080|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215081|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215082|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215083|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215084|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) scores indicate worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215085|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215086|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215168|NCT00771758|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.|||percenatage of participants|||Number
1215169|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
1215087|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215088|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215089|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215090|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215091|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215092|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. Positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215093|NCT00772005|Secondary|Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item scored on 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215094|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1227296|NCT00685334|Primary|Change From Baseline in Weight (Lbs.) at 12 Weeks|This study looked at change in weight before and after medication use.|baseline and 12 weeks||||lbs||Standard Deviation|Mean
1215095|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215096|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215097|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215098|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215099|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215100|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215101|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215102|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1227297|NCT00685295|Secondary|Occurrence of Untoward Opioid Side Effects|Subjects were monitored for any signs of untoward opioid side effects.|120 minutes||||Participants|||Count of Participants
1215103|NCT00772005|Secondary|Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215104|NCT00772005|Secondary|Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215105|NCT00772005|Secondary|Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215106|NCT00772005|Secondary|Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215107|NCT00772005|Secondary|Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215108|NCT00772005|Secondary|Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215109|NCT00772005|Secondary|Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215110|NCT00772005|Secondary|Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1229908|NCT00665626|Secondary|Absolute Neutrophil Count (ANC) <1500/mm3|The number of participants with ANC values less than 1500/mm3|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1215111|NCT00772005|Secondary|Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data shows change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215112|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215113|NCT00772005|Secondary|Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215114|NCT00772005|Secondary|Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215115|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215116|NCT00772005|Secondary|Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215117|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215118|NCT00772005|Secondary|Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215170|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
1215119|NCT00772005|Secondary|Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215120|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to endpoint. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1215121|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215122|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215123|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215124|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215125|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215126|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215171|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
1215127|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215128|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 1. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215129|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215130|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215131|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215132|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215133|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215134|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215172|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
1215135|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215136|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates severity of psychopathology in schizophrenics. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg.anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. The data here represents the change in total score from baseline to week 1 and higher (positive) scores indicate more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215137|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents change in total score from baseline to endpoint, higher (positive) scores indicate more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1215138|NCT00772005|Primary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1215139|NCT00771953|Primary|Progression Free Survival|For determining progression-free survival, progression was determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization until the first date that recurrent or progressive disease is objectively documented.||||days||95% Confidence Interval|Median
1215140|NCT00771927|Secondary|The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional.~Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population|||Treatment-Emergent Adverse Events|||Number
1215141|NCT00771927|Primary|The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation.~Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population|||Treatment-Emergent Adverse Events|||Number
1215142|NCT00771914|Primary|the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment|The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.|4 hours|Each participant acted as own control since each received the intervention (placebo, aspirin, lovaza, and both aspirin and lovaza) and had these effects compared to baseline (four hour effect of each intervention).|||seconds||Standard Deviation|Mean
1215143|NCT00771901|Secondary|VLDL-triglyceride (TG) Concentration||Baseline and four weeks||||mmol/l||Standard Deviation|Mean
1215144|NCT00771901|Secondary|Insulin Sensitivity in the Liver|HISI (hepatic insulin sensitivity index). HISI is the inverse of the product of endogenous glucose production and plasma insulin concentration and provides an index of how well circulating insulin controls the amount of glucose supplied by the liver. A higher number is indicative of greater insulin sensitivity.|Baseline and four weeks||||100/ (µmol/min * uIU/mL)||Standard Deviation|Mean
1215176|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
1215177|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
1215178|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
1215179|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
1215180|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
1215181|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Placebo)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Placebo arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
1215182|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
1215183|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via Interactive Voice Response (IVR) system in the morning."|10 days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
1215184|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 10|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 10|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
1215185|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 5|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 5|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
1215186|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 3|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 3|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
1215187|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 2|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 2|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
1215188|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study|"The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.~Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved."|Day 10|Intent-to-Treat subjects.|||second||Standard Deviation|Mean
1215189|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study|The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.|||chair stands||Standard Deviation|Mean
1215190|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study|The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.|Day 10|Intent-to-Treat subjects.|||seconds||Standard Deviation|Mean
1215191|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study|The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.|||meters||Standard Deviation|Mean
1215192|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief.|10 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215193|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief.|5 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215194|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215195|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215196|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 10 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215197|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 5 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief.|5 Days (120 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215198|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 3 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215199|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 2 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215200|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 10 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215201|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 5 Days (SPID120)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief.|5 Days (120 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215202|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 2 Days (SPID48)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215203|NCT00771758|Secondary|50% Responder Rate on Day 10.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1215204|NCT00771758|Secondary|30% Responder Rate on Day 10.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1215205|NCT00771758|Secondary|50% Responder Rate on Day 5.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1215206|NCT00771758|Secondary|30% Responder Rate on Day 5.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1215207|NCT00771758|Secondary|50% Responder Rate on Day 3.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1215208|NCT00771758|Secondary|30% Responder Rate on Day 3.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1215209|NCT00771758|Primary|Sum of Pain Intensity Difference Over 3 Days (SPID72)|"Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.~The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects."|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized patients who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1215210|NCT00771745|Secondary|Malignancy||Undefined|||||||
1215211|NCT00771745|Secondary|Serum Creatinine||Post-operative days 1-7, 30, 90 and 6 months|||||||
1215212|NCT00771745|Secondary|Severity of Biopsy-proven Rejection Using Banff 97 Criteria||Not defined|||||||
1215213|NCT00771745|Secondary|Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection||Not defined|||||||
1215214|NCT00771745|Secondary|Incidence of Infections||Not defined|||||||
1215215|NCT00771745|Secondary|Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.||Ongoing|||||||
1215216|NCT00771745|Primary|Composite End Point of Acute Rejection, Graft Loss or Patient Death|Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death|6 months|Patients received tacrolimus (goal level 10-15 ng/mL) and mycophenolate mofetil (2gm daily) at time of transplant. Methylprednisolone (MP), acetaminophen, and diphenhydramine were given as premedication for each rATG dose (500mg MP 1st dose, 250mg MP subsequent 2 doses, 125mg MP 4th dose).|||participants|||Number
1215217|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1215218|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)|As measured by a CDAI score of < 150 points.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1215219|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 8|As measured by a CDAI score of < 150 points.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1215220|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 8|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1215221|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 4|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 4|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1215222|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 6|As measured by a CDAI score of < 150 points.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1219142|NCT00740714|Secondary|Adverse Experiences: Nausea|Number of participants with nausea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1215223|NCT00771667|Primary|Number of Participants With Clinical Response at Week 6|As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1215224|NCT00771615|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
1215225|NCT00771615|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.“Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 42|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
1215226|NCT00771615|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
1215227|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
1215228|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
1215229|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215230|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215231|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215232|NCT00771615|Secondary|Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215233|NCT00771615|Secondary|Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
1215542|NCT00768651|Primary|C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
1215234|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||fold change||95% Confidence Interval|Geometric Mean
1215235|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215236|NCT00771615|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215237|NCT00771615|Secondary|HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
1215238|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||fold change||95% Confidence Interval|Geometric Mean
1215239|NCT00771615|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
1215240|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 0 to Day 42 and at Day 0 to Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215241|NCT00771615|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
1215242|NCT00771615|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215243|NCT00771615|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
1215244|NCT00771602|Secondary|52 Week Toxicity Rate|The definition of toxicities include any >/= grade 3 non-hematologic toxicity, >/= grade 3 infection, and any symptomatic (i.e. febrile) documented CMV (cytomegalovirus) reactivation, according to NCI-WG definitions.|52 weeks|||||||
1215245|NCT00771602|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from date of trial entry until documented progression of disease or death from any cause.|52 weeks or until disease progression|||||||
1215543|NCT00768651|Primary|Acute Insulin Responses to Arginine After 6 Months of Therapy|An intravenous arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function.|6 months|||||||
1215246|NCT00771602|Primary|Number of Patients With Molecular Remissions at 52 Weeks|Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.|52 weeks|No analysis available participant ineligible for evaluation; study terminated due to slow accrual.||||||
1215247|NCT00771537|Primary|Willingness to Participate in a HIV Vaccine Clinical Trial|Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).|Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.|Only participants who answered the Willingness to Participate questions on the survey were included in these analyses.|||units on a scale||Standard Deviation|Mean
1215248|NCT00771537|Primary|Number of Participants Who Accepted Rapid HIV Testing.|Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.|During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.||||participants|||Number
1215249|NCT00771472|Secondary|Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||hours||Standard Deviation|Geometric Mean
1215250|NCT00771472|Secondary|Part I: Time at Which Cmax Occurs (Tmax)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||hours||Full Range|Median
1215251|NCT00771472|Secondary|Part I: Maximum Drug Concentration (Cmax)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||µM||Standard Deviation|Geometric Mean
1215252|NCT00771472|Primary|Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)|"A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):~Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC~Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment~Grade 4 neutropenia lasting at least 5 days~Grade 4 thrombocytopenia~Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator~Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies"|Day 1 to Day 28||||participants|||Number
1215253|NCT00771472|Secondary|Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||µM*hr||Standard Deviation|Geometric Mean
1215254|NCT00771472|Primary|Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)|A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.|Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)||||participants|||Number
1215255|NCT00771407|Secondary|Stoma Quality of Life||Serially over 24 months|||||||
1215256|NCT00771407|Secondary|Stoma Complications||more than 1 month postoperatively|||||||
1215257|NCT00771407|Secondary|Stoma Complications||30 days|||||||
1215258|NCT00771407|Primary|Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.||24 months|Efficacy Evaluable Population (received assigned treatment, completed all protocol-required evaluations, no major protocol violations).|||participants|||Number
1215259|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.||||||
1215260|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Clinical response at DCIV defined as: 1) Improved-All or most pretherapy signs and symptoms of infection have improved and no additional antibiotic is required, 2) Failure-No response to therapy, persistence or progression of pretherapy signs and symptoms, 3) Indeterminate-Study data not available due to complications related to underlying medical condition, patient withdrawn from study or extenuating circumstances preclude classification as improved or failure.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.||||||
1215261|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at the 5 to 9 Day Post Therapy Early Follow-up Visit|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|5 to 9 days post therapy|This analysis was not completed due to early termination of the study.||||||
1215262|NCT00771277|Secondary|Zarit Burden Inventory|Caregiver burden, as measured by the 12-item Zarit Burden Interview (Bédard et al., 2001; Zarit, Reever, & Bach-Peterson J, 1980). Burden includes concepts such as lack of time because of care, strain, restriction of life, etc. Items are scored from never (0) to nearly always (4), and higher total scores indicate greater burden. Total scores range from 0 to 88.|baseline||||units on a scale||Standard Deviation|Mean
1215263|NCT00771277|Secondary|PHQ-9|The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001) assesses caregiver depression and anxiety on a scale from not at all (0) to nearly every day (3), with higher total scores indicating greater symptoms. Scores range from 0-27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively.|baseline||||units on a scale||Standard Deviation|Mean
1215264|NCT00771277|Primary|Number of Participants Who Reported 5 Themes|Six caregivers of TBI patients were interviewed; responses were transcribed and coded; inter-rater agreement was calculated. Themes were lack of understanding about TBI and its long-term effects and the differences between TBI and PTSD, privacy concerns, independence, fear of negative employment/financial repercussions, and difficulty in interactions with the Department of Defense (DoD) and the Department of Veterans Affairs (VA)|collected over 3 interviews of approximately 1 hour each||||participants|||Number
1215265|NCT00771264|Primary|"The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis."|A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.|13 weeks|Intent to treat|||participants|||Number
1215266|NCT00771238|Secondary|Cost of Rental Beds|Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only|End of study|Tertiary Care ICU patients|||US Dollars|||Number
1215267|NCT00771238|Primary|Indicence of Pressure Ulcers|New pressure ulcers were assessed|at the end of study period (21 days)|Tertiary Care ICU patients|||participants|||Number
1215268|NCT00771173|Primary|Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments|The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts.|24 hours|Per Protocol|||centimeters||Standard Deviation|Mean
1215269|NCT00771056|Secondary|Time to Next Treatment|number of months to time from last HCQ dose to next CLL treatment|1 yr|only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose|||months||Full Range|Mean
1215270|NCT00771056|Primary|Percentage of Participants With Response|Percentage of participants with a reduction of the absolute lymphocytic count- ALC|1 yr||||percentage of participants|||Number
1215271|NCT00770991|Primary|Change in Burden of Rectal Polyps|The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks.|Baseline and 36 weeks||||polyp number x mm||Standard Deviation|Mean
1215272|NCT00770991|Secondary|Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.|A pooled analysis of all participants was used for biomarker results. Tissue from normal mucosa and rectal polyps were obtained to assay KI 67 (proliferation) and TUNEL at baseline and end of treatment. A decrease in the value of KI 67 implies lower proliferation while an increase in TUNEL is suggestive of an increase in apoptosis.|baseline and 36 weeks||||percentage of brown staining of cells||Standard Deviation|Mean
1215273|NCT00770991|Primary|Change From Baseline to End of Study in Number of Rectal Polyps||Baseline and 36 weeks||||polyps||Standard Deviation|Mean
1215274|NCT00770965|Secondary|Investigator Global Assessment (IGA) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32|||||||
1215275|NCT00770965|Secondary|Change From Baseline in PASI|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, weeks 12, 14, 16, 20, 24, 28 and 32|||||||
1215276|NCT00770965|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, week 4|||||||
1215277|NCT00770913|Primary|Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)|Grade N indicates a normal appearance of lower esophageal mucosa|8 weeks|The primary analysis was on the full analysis set (FAS) population.|||Percentage of Participants|||Number
1215278|NCT00770861|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).|The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)||||mm Hg||Standard Deviation|Mean
1215279|NCT00770861|Primary|Change From Baseline in Trough Seated DBP at Week 8(LOCF).|The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)||||mm Hg||Standard Deviation|Mean
1215280|NCT00770809|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3|The type and grade of treatment-related toxicity will be tabulated by treatment arm.|Up to 30 days post-treatment|||||||
1215544|NCT00768651|Primary|HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy|HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.|6 months|||||||
1215281|NCT00770809|Secondary|Time to First Failure|Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.|Time from study entry to any recurrence ( up to 10 years)|||||||
1215282|NCT00770809|Secondary|Relapse-free Survival (RFS)|Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method.|Time from surgery to any recurrence (up to 10 years)|||||||
1215283|NCT00770809|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method|Time from randomization to death or last follow-up (up to 10 years)|||||||
1215284|NCT00770809|Secondary|Radiographic Response Rate (at Completion of Neoadjuvant Therapy)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).|Week 16|||||||
1215285|NCT00770809|Secondary|Pathologic Stage in the Breast and Axilla|Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system.|At time of surgery|||||||
1215286|NCT00770809|Primary|pCR Rate|Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.|At time of surgery|Participants who did not start protocol therapy or withdrew prior to surgery are excluded. Participants who did not undergo surgery are considered no having a pCR.|||percentage of participants||95% Confidence Interval|Number
1215287|NCT00770770|Primary|Visual Acuity|To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.|3 months||||Letters||Standard Error|Mean
1215288|NCT00770757|Post-Hoc|Survival Rate of CC-4047 Responders||Median follow-up 5.6 years (4.2-5.6 years)|Five participants have died and these were the participants who did not respond or were removed from study prior to cycle 3 due to adverse events.|||percentage of participants|||Number
1215289|NCT00770757|Post-Hoc|Chronic Graft-versus-host Disease Global Score at the Start/End of the Study|"Global scoring of chronic GvHD consists of questions about various organs including skin, genital tract, lungs, liver, and multiple others. The physician scores each organ from 0 to 3. Score 0 means the patient has no symptoms. Score 1 means the patient has mild symptoms. Score 2 means the patient has moderate symptoms. Score 3 means the patient has severe syptoms.~Mild scoring of chronic GvHD is only 1 or 2 organs or site (except the lung). No clinically significant functional impairment (maximum of score 1 in all affected organs or sites)~Moderate scoring of chronic GvHD is at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) or 3 or more organs or sites with no clinically significant functional impairment (maximum of 1 in all affected orgnas or sites)~Severe scoring of chronic GvHD is a major disability caused by chronic GvHD (score of 3 in any organ or site) and lung function score >=2."|1 year after last dose of CC-4047||||participants|||Number
1215290|NCT00770757|Post-Hoc|Organ System Response||1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable|||participants|||Number
1215291|NCT00770757|Secondary|Safety as Measured by the Most Common Adverse Effects and Reasons for Dose Reductions or Study-discontinuation|-Toxicities will be graded according to the NCI CTCAE v3.0.|30 days after last dose of CC-4047 or until resolution of event||||participants|||Number
1215292|NCT00770757|Primary|Overall Response (Complete Response + Partial Response + Other)|"CR is defined as complete resolution in all of signs and symptoms at all affected organs and tissues~PR is defined as improvement in greater than or equal to 1 organ/tissue with no progression in any other affected organ/tissue~Improvement in chronic GvHD symptoms less than what meets the definition of a PR is defined as other~Progressive disease is defined as failure of therapy to control chronic GvHD despite increasing the dose of primary therapy or adding second line treatments~No response is defined as no change in disease."|1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable|||participants|||Number
1215293|NCT00770692|Secondary|Mean Change From Baseline in Total Number of Awakenings|Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||Number of Awakenings||Standard Deviation|Mean
1215545|NCT00768651|Primary|Change From Baseline on Gastrin Level After One Month of Therapy|Gastrin levels were measured at baseline and at one month by method (manufacturer).|Baseline and One month|||||||
1215294|NCT00770692|Secondary|Mean Change From Baseline in Total Sleep Time|Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
1215295|NCT00770692|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO)|Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
1215296|NCT00770692|Primary|Incidence of Adverse Events|"Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)*100.~An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF."|Up to 25 weeks (24 weeks treatment period & 1 week follow-up)|Safety analysis set: All 161 non-elderly participants who were enrolled in the treatment period were included. All 164 elderly patients who were enrolled in the treatment period were included. The participant who was excluded from the efficacy analysis set was included in the safety analysis set because the participant had evaluable safety data.|||Percentage of Participants|||Number
1215297|NCT00770692|Secondary|Mean Change From Baseline In Sleep Latency|Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
1215298|NCT00770679|Primary|Change in Endothelial Function as Measured on MRI in the Legs||chance from baseline to end of study, up to 5 weeks|No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.||||||
1215299|NCT00770679|Primary|Change in Endothelial Function as Measured on MRI in the Arms||chance from baseline to end of study, up to 5 weeks|No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.||||||
1215300|NCT00770679|Primary|Mean Change in Low Density Lipoprotein (LDL)|Serum LDL, mg/dL (baseline LDL-follow-up LDL)|Change from baseline to follow-up, up to 5 weeks|3 participants were lost to follow-up, 3 participants did not have LDL values collected/reported at follow-up|||mg/dL||Standard Deviation|Mean
1215301|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (60.00).|The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1215302|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (30.00).|The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1219143|NCT00740714|Secondary|Adverse Experiences: Urinary Tract Infection|Number of patients with urinary tract infections|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1215303|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (12.00).|The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1215304|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (6.00).|The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1215305|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (3.00).|The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1215306|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (1.20).|The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1215307|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.60%)|The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1215308|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.30%).|The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1215309|NCT00770653|Secondary|Change From Baseline in Von-Willebrand Factor.|The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Error|Least Squares Mean
1215310|NCT00770653|Secondary|Change From Baseline in E-Selectin.|The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
1215311|NCT00770653|Secondary|Change From Baseline in Platelet Function.|The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||sec||Standard Error|Least Squares Mean
1215312|NCT00770653|Secondary|Change From Baseline in Thromboxane B2.|The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||pg/mL||Standard Error|Least Squares Mean
1215313|NCT00770653|Secondary|Change From Baseline in Soluble Vascular Cell Adhesion Molecule.|The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
1215314|NCT00770653|Secondary|Change From Baseline in Soluble Intracellular Adhesion Molecule.|The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
1215546|NCT00768651|Primary|Change From Baseline of GLP-1 Level After One Month of Therapy|Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.|Baseline and One month|||||||
1215315|NCT00770653|Secondary|Change From Baseline in Matrix Metallo Proteinase-9.|The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
1215316|NCT00770653|Secondary|Change From Baseline in Soluble CD40 Ligand.|The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||pg/mL||Standard Error|Least Squares Mean
1215317|NCT00770653|Secondary|Change From Baseline in Nitrotyrosine.|The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||nmol/L||Standard Error|Least Squares Mean
1215318|NCT00770653|Secondary|Intake of Study Medication Greater Than 80% and Less Than 120%.|The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||participants|||Number
1215319|NCT00770653|Secondary|Change From Baseline in Diastolic Blood Pressure.|The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mmHg||Standard Deviation|Least Squares Mean
1215320|NCT00770653|Secondary|Change From Baseline in Systolic Blood Pressure.|The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mmHg||Standard Error|Least Squares Mean
1215321|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).|The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/L||Standard Deviation|Mean
1215322|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Original).|The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/L||Standard Error|Least Squares Mean
1215323|NCT00770653|Secondary|Change From Baseline in Adiponectin.|The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||μg/mL||Standard Error|Least Squares Mean
1215324|NCT00770653|Secondary|Change From Baseline in Fasting Glucose.|The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1215325|NCT00770653|Secondary|Change From Baseline in Fasting Intact Proinsulin.|The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||pmol/L||Standard Error|Least Squares Mean
1215326|NCT00770653|Secondary|Change From Baseline in Glycosylated Hemoglobin.|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1215327|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol.|The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1215547|NCT00768651|Primary|Mean Daily Insulin Use (U/Day) After 6 Months of Therapy|Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.|6 months|||||||
1215548|NCT00768651|Primary|Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy||6 months|||||||
1215328|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Subfractions.|The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1215329|NCT00770653|Secondary|Change From Baseline in Triglycerides.|The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1215330|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.|The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1215331|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol.|The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1215332|NCT00770653|Primary|The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.|The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analysis was performed on participants with at least one valid baseline and post-baseline measurement. This condition was not fulfilled in 17 participants who were excluded from the all-participants-randomized set, leading to a full-analysis-set of 288 (146 vs. 142). Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1215333|NCT00770588|Secondary|Adverse Event|Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse events will be calculated.|AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored||||Participants|||Number
1215334|NCT00770588|Secondary|Symptom Improvement|Symptom improvement will be assessed from the 7-question Lung Cancer Subscale domain score derived from the FACT-L questionnaire. It is defined as an increase of two or more points on the LCS from randomization, maintained for 21 or more days. It will be calculated as the number of patients analysed with improvement.|at randomization, every 6 weeks until disease progression, and at discontinuation.||||Participants|||Number
1215335|NCT00770588|Secondary|Disease Control Rate (DCR)|DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase|Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.|||||||
1215336|NCT00770588|Secondary|Objective Tumour Response (ORR)|The objective tumour response will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.||||Participants|||Number
1215337|NCT00770588|Secondary|Overall Survival (OS)|The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died(which may include those who have been lost to follow up or who have withdrawn from the study for whatever reason), OS will be censored for the analysis at the last date at which the patients were known to be alive.|The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive.||||month||95% Confidence Interval|Median
1215338|NCT00770588|Primary|Progression Free Survival (PFS)|PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.||||month||95% Confidence Interval|Median
1215339|NCT00770562|Secondary|Percentage of Participants With an Initial Complete Response|Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.|||percentage of participants|||Number
1215340|NCT00770562|Secondary|Percentage of Participants With an Initial Response|Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.|||percentage of participants|||Number
1215549|NCT00768651|Primary|Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy|HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.|6 months|||||||
1215550|NCT00768651|Primary|Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy||6 months|||||||
1215341|NCT00770562|Primary|Percentage of Participants With a Sustained Response|Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.|Week 24|The Intent-to-Treat (ITT) population includes all participants who were randomized, who received at least (<) 1 dose of study medication, and who had at least 1 follow-up contact.|||percentage of participants|||Number
1215342|NCT00770510|Primary|Sleep Latency (SL)|The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Standard Deviation|Mean
1215343|NCT00770510|Secondary|Number of Awakenings (Objective & Subjective)|"Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Number of awakenings||Full Range|Median
1215344|NCT00770510|Secondary|Wake Time After Sleep Onset (WASO)- Objective & Subjective|"Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Full Range|Median
1215345|NCT00770510|Secondary|Sleep Efficiency|"Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent.~PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Percentage of time asleep of 8 hours||Full Range|Median
1215346|NCT00770510|Secondary|Total Sleep Time (Objective & Subjective)|"Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Full Range|Median
1215347|NCT00770510|Primary|Latency To Persistent Sleep (LPS)|The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Standard Deviation|Mean
1215348|NCT00770484|Primary|Maximal Oxygen Consumption Capacity (VO2 Max)||Over approximately 30 minutes, within 2 hours of receiving each intervention.||||mL/kg/min||Standard Error|Mean
1215349|NCT00770432|Primary|Number of Participants With a Complete Resolution at the Final Visit|A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.|24 hours to 3 days after last dose of seven day treatment period.|Per-Protocol Population|||Participants|||Number
1215350|NCT00770367|Secondary|NOx f2-isoprostanes|Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress|3 months|36 adults with diabetes enrolled in the study, and 31 completed the 7-month protocol. Adherence with medication was 93% during the trial according to pill counts at the final visit. Participants were allowed to take their other regular medications during the trial.|||Oxidative stress||Standard Error|Mean
1215351|NCT00770367|Primary|Asymmetric Dimethylarginine (ADMA) Level|Labs measured micro moles per liter of ADMA levels in participants.|3 months|Recruited 36 participants per randomization.1st analysis is serum Asymmetric Dimethylarginine ADMA at 12 weeks b/w groups.|||umol/L||95% Confidence Interval|Mean
1215352|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at TOC|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1215353|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at EOT|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1215354|NCT00770341|Secondary|EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).|"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1215355|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC|"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1215356|NCT00770341|Secondary|EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1215357|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)|"Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT).~MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline."|7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)|MITT-MRSA; One participant with possible MRSA RIE was enrolled. This participant was excluded from the efficacy population.|||Participants|||Number
1215358|NCT00770328|Secondary|Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy.||Baseline and 8 weeks|Unable to complete analysis due to TNF-a assay failure (see Outcome measure #3)||||||
1215359|NCT00770328|Secondary|Change in TNF-alpha Level||Baseline and 8 weeks|TNF-a assay did not work properly. Meaningless data resulted including negative values which are impossible.||||||
1215360|NCT00770328|Secondary|Change in CRP Level||Baseline and 8 weeks||||mg/dl||Standard Error|Mean
1215361|NCT00770328|Primary|Change in PAI-1 Level||Baseline and 8 weeks||||ng/ml||Standard Error|Mean
1215362|NCT00770315|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1215363|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1215551|NCT00768651|Secondary|Insulin Dose (U/Day)||After the 3 month washout period|||||||
1215991|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215364|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1215365|NCT00770315|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1215366|NCT00770315|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1215367|NCT00770289|Secondary|Number of Participants With Residual Symptoms in Case of Non Remission|Number of participants with residual symptoms who did not achieve remission was assessed. Remission according to HAM-D: HAM-D17 score =< 7 or HAM-D7 score =<3. Remission according to BDI: BDI score <10. HAM-D17: assessed 17 items associated with MD. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: assessed 7 items associated with MD. Total score: 0 to 26. BDI assessed severity of depressive symptoms. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. The total score: 0 to 63. For all the 3 scales, higher score indicated more severe depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||participants|||Number
1215368|NCT00770289|Secondary|Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)|HAM-D17: clinician-administered scale; assesses 17 items related to major depression (MD). Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: subset of HAM-D17; assesses 7 items related to MD. Total score: 0 to 26. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, physical symptoms of fatigue, weight loss, lack of interest in sex. Individual item scored on 4 point scale (0 to 3); 0=absent, 3=most severe. Total score: 0 to 63. For all the 3 scales, higher score represented more depression.|Baseline, Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available at baseline and were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1215369|NCT00770289|Secondary|Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)|Remission according to BDI: BDI score less than (<) 10. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1215370|NCT00770289|Primary|Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)|Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.|Week 12|Intent-to-treat (ITT) population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1215653|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Creatinine|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Micromole/Liter||Standard Error|Least Squares Mean
1215371|NCT00770224|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1215372|NCT00770224|Secondary|Response Rate|Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of the following. Positron emission tomography (PET) must be negative if no pre-treatment PET scan or when the PET was positive before therapy. If the PET scan was negative before therapy, all nodal masses must have regressed. no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. PR is ≥ 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD. In patients with no pre-treatment PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression|Eligible and evaluable patients were included in the analysis.|||Participants|||Count of Participants
1215373|NCT00770224|Secondary|5-year Overall Survival|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|0-5 years|Eligible and evaluable patients were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1215374|NCT00770224|Secondary|5-year Progression-free Survival|Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.|0-5 years|Eligible and evaluable patients were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1215375|NCT00770224|Primary|Percentage of Participants With 3-year Progression-free Survival (PFS)|Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.|0-3 years|Eligible and evaluable patients were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1215376|NCT00770211|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient’s Assessment on 4-point Scale|"Patient’s assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1215377|NCT00770211|Secondary|Responders at Maximum Frown at Day 30 by Investigator’s Rating on FWS|The investigator’s assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder as having a rating of none or mild|||Participants|||Number
1215378|NCT00770211|Secondary|1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale|"Patient’s assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1215379|NCT00770211|Secondary|Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS)|The investigator’s assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder defined as having a rating of none or mild|||Participants|||Number
1215654|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Units/Liter||Standard Error|Least Squares Mean
1215380|NCT00770211|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:~The investigator’s assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.~Patient’s assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.|||Particpants|||Number
1215381|NCT00770146|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1215382|NCT00770146|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1215383|NCT00770146|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||ratio||Standard Deviation|Mean
1215384|NCT00770146|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1215385|NCT00770146|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1215386|NCT00770146|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1215387|NCT00770146|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1215388|NCT00770146|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1215389|NCT00770146|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1215390|NCT00770146|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1215391|NCT00770146|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1215992|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215392|NCT00770146|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1215393|NCT00770146|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1215394|NCT00770146|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1215395|NCT00770146|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1215396|NCT00770146|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1215397|NCT00770146|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1215398|NCT00770146|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1215399|NCT00770146|Primary|Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1215400|NCT00770146|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. LDL-C was obtained using Friedewald’s calculation for patients with triglycerides ≤400 mg/dL and was directly measured by the central laboratory using ultracentrifugation for patients with triglycerides >400 mg/dL. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Inter-Quartile Range|Median
1215401|NCT00770120|Secondary|Frequency and Severity of Toxicities||Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.|Number of Subjects With Greater Than Grade 2 Toxicity|||participants|||Number
1215402|NCT00770120|Secondary|Overall Survival|Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Every 8 weeks until disease progression, up to 3 years.||||months||95% Confidence Interval|Median
1215403|NCT00770120|Secondary|Response|A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.|Every 8 weeks until disease progression, up to 3 years.||||percentage of overall response rate||95% Confidence Interval|Number
1215404|NCT00770120|Primary|Progression-Free Survival|Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a >= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease|Every 8 weeks until disease progression, up to 3 years.||||months||95% Confidence Interval|Median
1216076|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline|Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1215405|NCT00770029|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient’s Assessment on 4-point Scale.|"Patient’s assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1215406|NCT00770029|Secondary|Responders at Maximum Frown at Day 30 by Investigator’s Rating on FWS.|The investigator’s assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1215407|NCT00770029|Secondary|1-point Responders at Rest at Day 30 by Patient’s Assessment on 4-point Scale.|"Patient’s assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1215408|NCT00770029|Secondary|Responders at Rest at Day 30 by Investigator’s Rating on FWS.|The investigator’s assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1215409|NCT00770029|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on Facial Wrinkle Scale (FWS) and by Patient’s Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:~The investigator’s assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.~Patient’s assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.|||Participants|||Number
1215410|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 12||||newtons||Standard Deviation|Mean
1215411|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 8||||newtons||Standard Deviation|Mean
1215412|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 4||||newtons||Standard Deviation|Mean
1215413|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 12|One of the subjects that dropped from the study in the Arimoclomol arm, returned for the 12 month visit.|||units on a scale||Standard Deviation|Mean
1215414|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 8||||units on a scale||Standard Deviation|Mean
1215415|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 4||||units on a scale||Standard Deviation|Mean
1215416|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 12||||units on a scale||Standard Deviation|Mean
1215417|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 8||||units on a scale||Standard Deviation|Mean
1215418|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 4||||units on a scale||Standard Deviation|Mean
1215421|NCT00769704|Secondary|Response Interval|Response interval is defined as the interval between the date of randomization and the date of the last documented evidence of response (CR or PR as assessed by the Investigator) prior to any new anti-cancer therapy. Response Interval post response onset was censored if a patient was still in response at the last observation.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per Investigator assessment.|||months||95% Confidence Interval|Median
1215422|NCT00769704|Secondary|Time to Treatment Failure|"Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis.~Progressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point.~Clinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent to treat population|||months||95% Confidence Interval|Median
1215423|NCT00769704|Secondary|Response Onset|Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.|||months||95% Confidence Interval|Median
1215424|NCT00769704|Secondary|Duration of Response|The duration of response is defined as the longest individual period from entering response (CR or PR as assessed by the EAC) to the first documented evidence of the patient no longer meeting the criteria for being in response or death, whichever is earlier. Responses were censored at the last assessment showing response.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.|||months||95% Confidence Interval|Median
1215425|NCT00769704|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points.~Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
1215426|NCT00769704|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained.|From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months.|Intent-to-treat population|||months||95% Confidence Interval|Median
1215427|NCT00769704|Primary|Durable Response Rate|"Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline.~Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times.|||percentage of participants||95% Confidence Interval|Number
1215428|NCT00769652|Primary|Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
1215429|NCT00769652|Primary|Change in Weight||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
1215430|NCT00769652|Primary|Change in Fat Free Mass (FFM)||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
1215431|NCT00769561|Secondary|TMD Related Symptoms|TMD related symptoms, such as jaw pain, toothache or dizziness, were measured using a 41-item TMD symptom list. Following the SOMS-7 scale, intensity of symptoms experienced during the past week was rated from 0 (‘not at all’) to 4 (‘very high intensity’) (range 0 - 164). A sum score was built with higher scores indicating higher intensity of TMD related symptoms. The TMD symptom list has not been evaluated previously; however, large bivariate correlations with somatization (Pearson’s r = .79), medium to large correlations with pain intensity (r = .48), and medium correlations with depression (r = .37) and anxiety (r = .27) provide evidence of good convergent and divergent validity. Cronbach’s alpha level in the current sample was excellent (α = .93).|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up||||units on a scale||Standard Deviation|Mean
1215655|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|"All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing.~endpoints."|||Units/Liter||Standard Error|Least Squares Mean
1215432|NCT00769561|Primary|Jaw Use Limitations (JDL)|Jaw use limitations were measured using the Jaw Disability List (JDL) from the RDC/TMD. The JDL asks the patient to rate interference with eleven oral activities, for example chewing or talking. We used an 11-point numeric rating scale (from 0 'no limitation' to 10 'maximum limitation') instead of ratings of ‘yes’ and ‘no’ (range 0 - 110). Higher values indicate higher levels of jaw use limitations. Cronbach's alpha was .86 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1215433|NCT00769561|Secondary|Pain Coping (FESV)|Cognitive and behavioral pain coping strategies were assessed with Coping Strategies Scale from the German Pain Coping Questionnaire (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV). The scale asks for the use of 24 cognitive (e.g. cognitive restructuring) and behavioral (e.g. use of relaxation techniques) strategies for coping with pain on a scale ranging from 1 ('fully disagree') to 6 ('fully agree') (range 24-144). A sum score was used with higher scores indicating more adaptive coping. Cronbach’s alpha level was α = .80.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1215434|NCT00769561|Secondary|General Anxiety Symptoms (GAD-7)|General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 (‘not at all’) to 3 (‘more than half of the days’) rating scale (range 7-21). Higher scores indicate higher levels of anxiety. Cronbach’s alpha level in the current sample was α = .64.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1215435|NCT00769561|Secondary|Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)|Depressive symptoms were measured using the Centre for Epidemiological Studies Depression scale (CES-D). The CES-D asks for the frequency of 20 symptoms of depression during the past week on a scale ranging from 0 (‘less than 1 day’) to 3 (‘5 to 7 days’) (range 0-60). Higher scores indicate more depressive symptoms. It is suitable for use in chronic pain patients as it relies less on physical symptoms of depression than do other measures. Cronbach’s alpha level in the current sample was α = .89.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1215436|NCT00769561|Secondary|Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)|Somatoform complaints during the past week were assessed using the Screening for Somatoform Symptoms (SOMS-7). 32 medically unexplained symptoms (29 for male subjects) representing DSM-IV criteria for somatization disorder were rated on a 0 ('not at all') to 4 ('very much') scale (range 0 - 128 for women and 0 - 116 for men). A sum score was calculated with higher scores indicating higher intensity and burden of somatoform complaints. In the current sample, Cronbach’s alpha level was α = .88.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1215437|NCT00769561|Primary|Pain Disability (Pain Disability Index)|Pain related disability was assessed using the Pain Disability Index (PDI). The PDI is a brief self-rating scale which assesses the level of pain related disability in seven areas of daily life (e.g., social activity, self-care) on a 0 (no disability) -10 (maximum disability) numeric rating scale (range 0 - 70). Higher values indicate higher disability levels. Cronbach's alpha was .87 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1215438|NCT00769561|Primary|Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))|"Characteristic pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)):~Characteristic pain intensity was calculated by averaging ratings of current pain, average pain, and worst pain in the past month on a numeric rating scale from 0 (no pain) to 10 (maximum pain), as recommended by RDC/TMD (range 0 - 10). Higher values indicate higher pain levels."|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1215439|NCT00769314|Secondary|Patient Assessment of Efficacy of the Treatment|At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.|||participants|||Number
1215440|NCT00769314|Secondary|Patient Satisfaction With Treatment|At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.|||participants|||Number
1215441|NCT00769314|Secondary|Symptom Intensity (Visual Analogue Scale [VAS])|"Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from 0 was measured in millimeters (0 - 100) and recorded."|Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)|This endpoint was analyzed using the safety population, which consisted of all randomized patients who took at least 1 dose of study medication.|||units on a scale (0 - 100)||Standard Deviation|Mean
1215442|NCT00769314|Secondary|Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up|Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.|||participants|||Number
1215656|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Units/Liter||Standard Error|Least Squares Mean
1215443|NCT00769314|Secondary|Time to Recurrence of Non-aborted Lesions During 9-month Follow-up|Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.|||Days||95% Confidence Interval|Median
1215444|NCT00769314|Primary|Time to Healing (TTH) of Vesicular Primary Lesion|Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.|Assessed from time of treatment initiation through Day 14|The modified Intent-to-Treat (mITT) population was the population used for analysis of this endpoint. The mITT population included all randomized patients who received at least one dose of study medication and who reached the vesicular stage (ie, episodes that progressed through macula, papule, vesicle, crust and healing).|||Days||95% Confidence Interval|Median
1215445|NCT00769314|Secondary|TTH of Aborted Primary Lesions|TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the subgroup of patients within the ITT population with aborted lesions.|||Days||95% Confidence Interval|Median
1215446|NCT00769314|Secondary|Time to Cessation of Symptoms|Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the ITT population.|||Days||95% Confidence Interval|Median
1215447|NCT00769314|Secondary|Duration of Episode (DOE)|For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last.|Assessed from initiation of treatment to Day 14|This endpoint was analyzed using the ITT population.|||Days||95% Confidence Interval|Median
1215448|NCT00769314|Secondary|TTH of Non-primary Lesions (Aborted Lesions Excluded)|TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using a subgroup of patients in the ITT population with non-primary lesions.|||Days||95% Confidence Interval|Median
1215449|NCT00769314|Secondary|Abortion of Primary Lesions|Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using the Intent-to-Treat (ITT) population, which consisted of all randomized patients who received at least one dose of study medication and who had complete information recorded for the application time.|||participants|||Number
1215450|NCT00769184|Secondary|Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions|Mean percent improvement in disease severity using Physician Global Assessment (PGA) [PGA scale: Clear (0) - Very Severe (5)] and overall severity scores of target lesions (OTLS) [OTLS scale None (0) - Very Severe (4)] based on erythema, scaling and induration, at each visit interval.|Weeks 2, 6, & 12|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.|||Mean Percent Improvement||Full Range|Mean
1215451|NCT00769184|Primary|Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.|Those patients that have reached a PGA score of zero [PGA scale: clear (0) - very severe (5)], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.|Weeks 2, 6, & 12.|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.|||percentage of participants|||Number
1215452|NCT00769132|Secondary|Prostaglandin I Metabolite (PGI-M)|The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
1215453|NCT00769132|Primary|Urinary 11-dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
1215454|NCT00769119|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215993|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215455|NCT00769119|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215456|NCT00769119|Secondary|Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215457|NCT00769119|Secondary|Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215458|NCT00769119|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215459|NCT00769119|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215460|NCT00769119|Secondary|Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215461|NCT00769119|Secondary|Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215462|NCT00769119|Secondary|Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215463|NCT00769119|Primary|St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C)|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
1215464|NCT00769119|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||events|||Number
1215657|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Albumin|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Gram/Liter||Standard Deviation|Least Squares Mean
1215465|NCT00769119|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1215466|NCT00769119|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1215467|NCT00769119|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/s||Standard Error|Least Squares Mean
1215468|NCT00769119|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1215469|NCT00769119|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 Second (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1215470|NCT00769119|Primary|Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1215471|NCT00769119|Primary|24-hour Sputum Weight(g)|Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||g||Standard Error|Least Squares Mean
1215472|NCT00769119|Primary|Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215473|NCT00769119|Primary|Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1215474|NCT00769067|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.|Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||weeks||95% Confidence Interval|Median
1215475|NCT00769067|Secondary|Duration of Response (DR)|Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date [if none of the event dates available] minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Analysis population included sub-set of participants from ITT population who had a confirmed objective tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
1215537|NCT00768651|Secondary|Acute Insulin Response to Arginine After the 3 Month Washout Period|An intravenous Arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function. The Arginine is a proxy for insulin secretory reserve (Robertson:2004br)(Rickels:2007cg) and correlates with islet mass in the context of islet allo-transplant (Ryan:2002cg), auto-transplant (Teuscher:1998eu) and hemipancreatectomy (Seaquist:1992iv). An increase in Arginine (AIRarg) would have suggested an increase in beta cell mass.|3 months - washout period|||||||
1215476|NCT00769067|Secondary|Best Overall Response (BOR)|Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||participants|||Number
1215477|NCT00769067|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||percentage of participants||95% Confidence Interval|Number
1215478|NCT00769067|Primary|Progression-Free Survival (PFS)|PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date [if the event date unavailable] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Intent-to-treat (ITT) population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||weeks||95% Confidence Interval|Median
1215479|NCT00769067|Other Pre-specified|Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)|Only participants from “Dacomitinib” treatment arm were planned to be analyzed for this outcome.|C1D10-14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis population: all participants who received >=1 dose of study medication, with treatment assignments designated according to actual study treatment received, and from whom at least 1 PK sample was obtained. Here “n” signifies participants who were evaluable at specified time-point.|||ng/mL||Standard Deviation|Mean
1215480|NCT00769067|Other Pre-specified|Soluble Protein Biomarkers Level|Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin [E-cadherin]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.|Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)|Biomarker analysis population: participants who received >=1 dose and had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. “N”(number of participants analyzed): participants evaluable for this measure; “n”: participants evaluable at each time-point for each arm respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1215481|NCT00769067|Other Pre-specified|Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation|Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as “unknown”. Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR.|Baseline|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. The participants under the category EGFR T790M Mutation are already included in the EGFR Mutant category.|||participants|||Number
1215482|NCT00769067|Secondary|Dermatology Life Quality Index (DLQI)|DLQI: 10-item questionnaire to measure how much the participant’s skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.|Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. Here “N” (number of participants analyzed) signifies participants evaluable for this measure; “n” signifies participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1215493|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)|Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: <LLN-30; Gr 2: <30-20; Gr 3&4: <20.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1215538|NCT00768651|Primary|Weight Change From Baseline After 6 Months of Therapy|Measuring the weight change from baseline at months: 1, 3, 6 and 9.|6 months|||||||
1215483|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline <=-10), Worsened (if average scales change from baseline >=10), and Stable (if average scales change from baseline >-10 but <10) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.|||participants|||Number
1215484|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales >=10; for symptom scale/item <=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales <=-10; for symptom scale/item >=10), and Stable (if average scales change from baseline >-10 but <10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.|||participants|||Number
1215485|NCT00769015|Secondary|Quality of Life: Social Function|Self-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1215486|NCT00769015|Secondary|Quality of Life: Role Functioning|Self-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1215487|NCT00769015|Secondary|Quality of Life: Mental Health|Self-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1215488|NCT00769015|Secondary|Vision Function: Near Activities|Near vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1215489|NCT00769015|Secondary|Quality of Life: Dependency|Self-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1215490|NCT00769015|Secondary|Vision Function: Distance Activities|Distance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1215491|NCT00769015|Primary|Depression|The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. < 20/100), baseline better eye scotoma size, baseline depression scores [Patient Health Questionnaire (PHQ-9)], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.|4 months||||participants|||Number
1215492|NCT00768989|Secondary|Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4|AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1215539|NCT00768651|Primary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy||6 months|||||||
1215494|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4|Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1–10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1215495|NCT00768989|Secondary|Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants|ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1215496|NCT00768989|Secondary|Raltegravir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Standard Deviation|Mean
1215497|NCT00768989|Secondary|Atazanavir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Standard Deviation|Mean
1215498|NCT00768989|Secondary|Atazanavir Individual Inhibitory Quotient (IQ)|Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Units on a Scale||Full Range|Geometric Mean
1215499|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval|AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1215500|NCT00768989|Secondary|Raltegravir AUC (0-12h) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1215501|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1215502|NCT00768989|Secondary|Raltegravir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1215503|NCT00768989|Secondary|Atazanavir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng*h / mL||Standard Deviation|Geometric Mean
1215504|NCT00768989|Secondary|Raltegravir Cmin 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1215505|NCT00768989|Secondary|Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1215506|NCT00768989|Secondary|Raltegravir Tmax|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Full Range|Geometric Mean
1215507|NCT00768989|Secondary|Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Full Range|Geometric Mean
1215508|NCT00768989|Secondary|Raltegravir Cmax in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
1215509|NCT00768989|Secondary|Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
1215510|NCT00768989|Secondary|Mean Change From Baseline in Electrocardiogram Findings|The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24.|From Baseline to Week 24|All randomized participants who received at least 1 dose of study medication.|||msec||Standard Error|Mean
1215511|NCT00768989|Secondary|Mean Change From Baseline in Total Bilirubin Level||From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication.|||mg/dL||Standard Error|Mean
1215512|NCT00768989|Secondary|Baseline and Mean Change From Baseline in Total Cholesterol Levels|The mean change from baseline in participant fasting lipids was determined using fasting serum samples.|From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication. N=number of participants analyzed; n=number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
1215540|NCT00768651|Primary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.|Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
1215513|NCT00768989|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.|Week 1 to Week 96, continuously|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1215514|NCT00768989|Secondary|Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count||From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study medication and had baseline and timepoint results.|||cells/mm^3||Standard Error|Mean
1215515|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96||At Week 96 from Baseline|This analysis was not preformed due to early termination of the study.|||Participants|||Number
1215516|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48||At Week 48 from Baseline|The study terminated early, and this analysis was only done at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.|||Participants|||Number
1215517|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24|NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1215518|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96|Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases.|At Weeks 48 and 96 from Baseline|The study terminated early, and this analysis was done only at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.|||Participants|||Number
1215519|NCT00768989|Secondary|Number of Nonresponders at Week 8|Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL.|At Week 8 from Baseline|The first 60 participants randomized, who received at least 1 dose of study medication.|||Participants|||Number
1215520|NCT00768989|Primary|Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24|The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC).|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1215521|NCT00768898|Primary|Conjunctival Staining at 5 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|5 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1215522|NCT00768898|Primary|Conjunctival Staining at 4 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|4 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1215523|NCT00768898|Primary|Conjunctival Staining at 3 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|3 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1215524|NCT00768898|Primary|Conjunctival Staining at 2 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|2 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1215525|NCT00768898|Primary|Conjunctival Staining at 1 Minute|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|1 minute after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1215541|NCT00768651|Primary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
1215526|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||units on a scale||95% Confidence Interval|Mean
1215527|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT)|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||units on a scale||95% Confidence Interval|Mean
1215528|NCT00768755|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Subgroup of participants from the FA population with a confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
1215529|NCT00768755|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1215530|NCT00768755|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1215531|NCT00768755|Primary|Progression-Free Survival (PFS)|"Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was Death) or from the end of study data."|Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Full analysis (FA) population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1215532|NCT00768651|Secondary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|After the 3 month washout period|||||||
1215533|NCT00768651|Secondary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period|||||||
1215534|NCT00768651|Secondary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period|||||||
1215535|NCT00768651|Secondary|C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a Mixed Meal Tolerance Test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function. Ther|After the 3 month washout period|||||||
1215536|NCT00768651|Secondary|HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period|Measuring of HbA1c using method (manufacturer) at baseline, and months: 1, 3, 6, 9.|After the 3 month washout period|||||||
1215552|NCT00768651|Secondary|Insulin Independence After the 3 Month Washout Period|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|After the 3 month washout period|Per Protocol Set of participants; The subset of participants in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary and secondary variables.|||% of insulin indipendent participants|||Number
1215553|NCT00768651|Primary|The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|6 months|Per Protocol Set of participants: The participants of subjects in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary variables.|||proportion of participants||95% Confidence Interval|Number
1215554|NCT00768599|Secondary|Mycological Cure: Mocassin Disease|Negative KOH and negative fungal culture at Day 43|43|MITT|||Participants|||Number
1215555|NCT00768599|Secondary|Mycological Cure: Interdigital Disease|Negative KOH and negative fungal culture at Day 43|43|MITT|||Participants|||Number
1215556|NCT00768599|Secondary|Effective Treatment: Mocassin Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT|||Participants|||Number
1215557|NCT00768599|Primary|Complete Cure Rate: Moccasin Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|43 Days|MITT|||Participants|||Number
1215558|NCT00768599|Secondary|Effective Treatment: Interdigital Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT|||Participants|||Number
1215559|NCT00768599|Primary|Complete Cure Rate: Interdigital Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|Day 43|MITT|||Participants|||Number
1215560|NCT00768560|Secondary|Target Blood Pressure Achievement in All Subjects|Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg. Subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg.|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
1215561|NCT00768560|Secondary|Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder|Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
1215562|NCT00768560|Secondary|Target Blood Pressure Achievement in Non-elderly (<65)|Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
1215563|NCT00768560|Secondary|Target Blood Pressure Achievement in Elderly (≥65)|Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
1215564|NCT00768560|Secondary|Differences of Diastolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis|||mm Hg||Standard Deviation|Mean
1215565|NCT00768560|Secondary|Differences of Systolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis|||mm Hg||Standard Deviation|Mean
1215566|NCT00768560|Primary|Change of Sitting Blood Pressure|Changes of sitting SBP and DBP (trough values) from baseline (ie [trough BP at the end of each period during the double-blind treatment period] minus [trough BP at the end of the baseline treatment period])|Baseline and after 2 weeks treatment|Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.|||mm Hg||Standard Error|Least Squares Mean
1215567|NCT00768521|Secondary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 1|All patients|||Percentage change||90% Confidence Interval|Least Squares Mean
1215568|NCT00768521|Primary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 7|All patients|||Percentage change||90% Confidence Interval|Least Squares Mean
1215569|NCT00768469|Primary|Maximum Tolerated Dose|The maximum tolerated dose of neratinib, as determined by the incidence of DLTs, in combination with paclitaxel 80 mg/m^2, in subjects with advanced solid tumors.|From first dose day through day 28.|Patients with at least one dose of neratinib.|||mg|||Number
1219144|NCT00740714|Secondary|Adverse Experiences: Headache|Number of participants with headache|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1215570|NCT00768469|Secondary|Duration of Response|Number of weeks from the time at which measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date on which recurrence or progressive disease (PD) is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started, for responders only, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From start date of response to first disease progression, up to 71 weeks.|Patients with Partial Response (PR) or Complete Response (CR) in the evaluable population.|||weeks||95% Confidence Interval|Median
1215571|NCT00768469|Secondary|Progression Free Survival|Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.|From first dose date to progression/death, up to 78 weeks.|Subjects who met the eligibility criteria, received at least 2 weeks of neratinib and at least 2 doses of paclitaxel, and underwent at least 1 follow-up tumor assessment at approximately cycle 2 (week 8). In the case of disease progression prior to week 8, a clinical assessment of progressive disease was adequate.|||weeks||95% Confidence Interval|Median
1215572|NCT00768469|Secondary|Objective Response Rate|Percentage of participants with partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression/death or last tumor assessment, up to 78 weeks.|Subjects who met the eligibility criteria, received at least 2 weeks of neratinib and at least 2 doses of paclitaxel, and underwent at least 1 follow-up tumor assessment at approximately cycle 2 (week 8). In the case of disease progression prior to week 8, a clinical assessment of progressive disease (PD) was adequate.|||percentage of participants||95% Confidence Interval|Number
1215573|NCT00768469|Primary|Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT Events|The incidence of DLTs in subjects with advanced solid tumors, treated with neratinib in combination with paclitaxel 80 mg/m^2. DLT was defined as any neratinib plus paclitaxel related Grade 3 or 4 nonhematologic toxicity or Grade 4 hematologic toxicity with few exceptions.|From first dose day through day 28.|Patients with at least one dose of neratinib.|||percentage of participants.|||Number
1215574|NCT00768430|Primary|MADRS|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression.|24 hours post-infusion||||units on a scale||95% Confidence Interval|Mean
1215575|NCT00768300|Secondary|Percentage of Participants Who Developed PH on Study|The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.|Up to 48 weeks|Participants in the Full Analysis Set without PH at baseline were analyzed.|||percentage of participants|||Number
1215576|NCT00768300|Secondary|Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
1215577|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George’s Respiratory Questionnaire (SGRQ)|The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
1215578|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
1215579|NCT00768300|Secondary|Change in 6MWT at Week 48|The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||meters||Standard Deviation|Mean
1215580|NCT00768300|Secondary|Change in DLCO % Predicted at Week 48|DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||percent change in DLCO % predicted||Standard Deviation|Mean
1215581|NCT00768300|Secondary|Change in FVC % Predicted at Week 48|FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||percent change in FVC % predicted||Standard Deviation|Mean
1215582|NCT00768300|Secondary|Proportion of Participants With No Disease Progression or Death at 48 Weeks|The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.|Baseline and Week 48|Full Analysis Set|||percentage of participants|||Number
1215583|NCT00768300|Primary|Time to Death or Disease (IPF) Progression.|"The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:~Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days~Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan~All-cause mortality"|Up to 48 months|Full Analysis Set: participants who were randomized and treated|||weeks||Inter-Quartile Range|Median
1215584|NCT00768287|Other Pre-specified|Number of Surgeries Requiring Blood Transfusions|Measure was assessed during Surgical Substudy.|During the surgical procedure||||Major surgeries|Major surgeries||Count of Units
1215585|NCT00768287|Other Pre-specified|Hemostasis Following Surgery|Surgeon assessment of hemostasis at 12 and 24 hours after surgery using the following descriptors: superior, adequate, or poorly controlled. Measure was assessed during Surgical Substudy.|12 and 24 hours after surgery||||Major surgeries|Major surgeries||Count of Units
1215586|NCT00768287|Other Pre-specified|Blood Loss During Surgery|Surgeon assessment of blood loss during the procedure using the following descriptors: less than expected, expected, or more than expected. Measure was assessed during Surgical Substudy.|During the surgical procedure|Major surgeries include synovectomy, knee or hip replacement, total tooth extraction, surgery for intracranial hemorrhage, radial head excision, arthrodesis, ankle surgery, abdominal surgery, prostatectomy, or surgery for major muscle bleed repair|||Major surgeries|Major surgeries||Count of Units
1215587|NCT00768287|Secondary|Annualized Bleed Rate|Measure was assessed during the Treatment Study|Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months|The 68 patients in the Treatment Study (Part 2) were assigned to an initial treatment regimen as follows: prophylaxis (n=58), on demand (n=9), and unassigned (n=1). Patients were allowed to switch regimens during the course of the study. As a result 61 patients were treated with prophylaxis and 12 patients were treated on demand.|||Bleeds/year||Inter-Quartile Range|Median
1215588|NCT00768287|Secondary|Volume of Distribution (Steady State)|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||dL/kg||Standard Deviation|Mean
1215589|NCT00768287|Secondary|Clearance|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||dL/kg*hr||Standard Deviation|Mean
1215590|NCT00768287|Secondary|Mean Residence Time|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||hours||Standard Deviation|Mean
1215591|NCT00768287|Secondary|Incremental Recovery|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||IU/dL per IU/kg||Standard Deviation|Mean
1215592|NCT00768287|Secondary|Concentration (Max)|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||IU/dL||Standard Deviation|Mean
1215593|NCT00768287|Secondary|Terminal Half-life|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||hours||Standard Deviation|Mean
1215594|NCT00768287|Secondary|Area Under the Curve (0-72 hr)|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||IU*hr/dL||Standard Deviation|Mean
1215595|NCT00768287|Secondary|Area Under the Curve (0-inf)|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||IU*hr/dL||Standard Deviation|Mean
1215596|NCT00768287|Primary|Degree of Hemorrhage Control by Treatment Regimen|"Subject rating of bleed control within 6 hours of the time bleeding has stopped:~Excellent: a dramatic response with abrupt pain relief and clear reduction in joint or hemorrhage site size;~Good: pain relief or reduction in hemorrhage site size that may have required an additional infusion for resolution;~Fair: probable or slight beneficial response usually requiring one or more additional infusions for resolution;~Poor: no improvement or condition worsens."|Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months|The 68 patients in the Treatment Study (Part 2) were assigned to an initial treatment regimen as follows: prophylaxis (n=58), on demand (n=9), and unassigned (n=1). Patients were allowed to switch regimens during the course of the study. As a result 61 patients were treated with prophylaxis and 12 patients were treated on demand.|||Bleeding Episodes|Bleeding Episodes||Count of Units
1220933|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)||12 weeks|ITT; LOCF|||percentage of superficial cells||Standard Deviation|Mean
1215597|NCT00768261|Secondary|Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change|The ADAS-Cog evaluates cognition and differentiates normal from impaired cognitive functioning. The total score is the summed number of errors in each task. The greater the impairment, the greater the score. We combined the dementia of the Alzheimer's type patients receiving all treatments together and grouped them into 3 subgroups according to the rates of change(roc) of their ADAS-Cog scores. To determine trends in hippocampal volume atrophy over time we compared the patients showing most negative ADAS-Cog rate of change (improving), patients with most positive ADAS-cog roc (worsening), patients with intermediate, near-zero ADAS-Cog roc (stable) .|two years|We combined the DAT patients who received any treatment (donepezil or combined) & used the annual roc in ADAS-Cog to equally separate them into 3 subgroups; improving (1/3 negative ADAS-Cog roc), stable (1/3 near-zero ADAS-Cog change) & worsening (1/3 positive ADAS-Cog change).|||(mm^3/year)||Standard Deviation|Mean
1215598|NCT00768261|Primary|Rate of Change of Hippocampal Volume Slope||2 years||||mm^3/year||Standard Deviation|Mean
1215599|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 90|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215600|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 30|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215601|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 12|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215602|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 7|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215603|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 5|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215604|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 3|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215605|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|30 days|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215606|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|12 days|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215607|NCT00768222|Primary|Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)|Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar|30 days (+/- 5) post-operative|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1215608|NCT00768144|Secondary|Progression-Free Survival|Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.|||weeks||95% Confidence Interval|Median
1215658|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Uric Acid|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Micromole/Liter||Standard Error|Least Squares Mean
1215609|NCT00768144|Secondary|16-Week Progression-Free Survival|16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods. Patients alive and progression-free at last follow-up are censored. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
1215610|NCT00768144|Primary|Overall Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
1215611|NCT00768118|Primary|The Magnitude of Change in Blood Lymphocyte NF-kB Level|The target accrual goal is 15 subjects. It is hoped that of those 15, at least 10 will be intervention compliant, and provide both planned blood samples. NF-kB levels will be measured using a supershift assay, which tests the specificity and level of NF-kB in the sample by measuring the optical density of a scan. With 10 patients, the mean difference in blood lymphocyte NF-kB level could be estimated to within 0.44 standard 7 deviations, with 80% confidence. That is reasonable precision and confidence level for a small pilot study, and should provide sufficiently precise estimates for use in planning a subsequent study.|15 days||||Optical Density unit||90% Confidence Interval|Mean
1215612|NCT00768066|Secondary|Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 Months post-catheterization||||percent change||95% Confidence Interval|Mean
1215613|NCT00768066|Secondary|Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.|Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months post-catheterization||||units on a scale||95% Confidence Interval|Mean
1215614|NCT00768066|Secondary|Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 months post-catheterization||||meters||95% Confidence Interval|Mean
1215615|NCT00768066|Secondary|Number of Deaths||12-months post-catheterization||||participants|||Number
1215616|NCT00768066|Secondary|Ectopic Tissue Formation.||12 months post-catheterization||||participants|||Number
1215617|NCT00768066|Secondary|Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI.||12 months post-catheterization||||participants|||Number
1215618|NCT00768066|Secondary|Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization||||ng/mL||95% Confidence Interval|Mean
1215619|NCT00768066|Secondary|Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization||||ng/mL||95% Confidence Interval|Mean
1215620|NCT00768066|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||one month post-catheterization||||participants|||Number
1215621|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12|American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215622|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12|American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215659|NCT00767806|Secondary|Participants Who Discontinued From Baseline to 12 Weeks|Reasons for discontinuation are listed in the participant flow.|baseline, 12 weeks|All randomized participants.|||participants|||Number
1220934|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)||12 weeks|ITT; LOCF|||percentage of parabasal cells||Standard Deviation|Mean
1215623|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12|American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215624|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12|American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215625|NCT00768053|Secondary|Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2|Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Baseline up to Week 12|All injected subjects population; DAS28 assessed at Week 4 and Week 12; sustained LDAS could only have been observed beyond Week 12. Time to event analysis not possible within study duration.|||participants|||Number
1215626|NCT00768053|Secondary|Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215627|NCT00768053|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215628|NCT00768053|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215629|NCT00768053|Secondary|Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215630|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||percentage of participants|||Number
1215631|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||percentage of participants|||Number
1215733|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators|Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1215632|NCT00768053|Secondary|Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable.|Week 4, Week 12|All injected subjects population. Unacceptable value put to participants prematurely withdrawn or with missing data; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||scores on a scale|||Number
1215633|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||percentage of participants|||Number
1215634|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||percentage of participants|||Number
1215635|NCT00768053|Secondary|Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement.|Week 4, Week 12|All injects subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||scores on a scale|||Number
1215636|NCT00768053|Secondary|Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12|EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1215637|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 12|All injected subjects population|||standardized response mean|||Number
1215638|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 4|All injected subjects population|||standardized response mean|||Number
1215639|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.|||correlation coefficient||95% Confidence Interval|Number
1215640|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12|PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Week 12|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
1215641|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status|PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Baseline, Week 4|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
1215642|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.|||correlation coefficient||95% Confidence Interval|Number
1215643|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Week 12|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
1215644|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Week 4|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
1215645|NCT00768053|Primary|Simplicity: Time for Completion of the EULAR-RAID Questionnaire|EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected).|Baseline up to Week 12|All injected subjects population. Data was not summarized; the time to complete the EULAR-RAID questionnaire was not analyzed separately from other components of the EULAR questionnaire (EULAR-RAID, questions on pain, Modified Health Assessment Questionnaire, sleep and coping)|||minutes||Standard Deviation|Mean
1215646|NCT00768053|Primary|Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score|EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial).|Screening, baseline|All injected subjects population: received at least 1 dose of study treatment (same as Safety population).|||intraclass correlation coefficient||95% Confidence Interval|Number
1215647|NCT00768040|Primary|Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment|The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor|Baseline to week 12|This study was terminated early due to low recruitment of patients.|||μm||Standard Error|Least Squares Mean
1215648|NCT00767806|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale|The Columbia Suicide Severity Rating Scale (C–SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.|baseline through 12 weeks|All randomized participants.|||participants|||Number
1215649|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Pulse Rate|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||beats per minute||Standard Error|Least Squares Mean
1215650|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||kilogram||Standard Error|Least Squares Mean
1215651|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Blood Pressure|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||millimeter mercury||Standard Error|Least Squares Mean
1215652|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Total Protein|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Gram/Liter||Standard Error|Least Squares Mean
1215660|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism~Presenteeism~Work productivity loss~Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment."|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints. Not for all participants were data for all WPAI items available.|||units on a scale||Standard Deviation|Mean
1215661|NCT00767806|Secondary|Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension|Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
1215662|NCT00767806|Secondary|Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
1215663|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
1215664|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
1215665|NCT00767806|Secondary|Patient's Global Impression of Improvement (PGI-I) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
1215666|NCT00767806|Secondary|Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
1215667|NCT00767806|Secondary|Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution|The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint.|12 weeks|All randomized participants with non-missing baseline value; baseline observation carried forward method was used to impute missing endpoints.|||participants|||Number
1215668|NCT00767806|Secondary|Number of Sustained Responders at 12 Week Endpoint|Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
1215811|NCT00766415|Primary|Induced Sputum: Neutrophils Count (%)|Change in Induced sputum Neutrophils count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215669|NCT00767806|Secondary|Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
1215670|NCT00767806|Secondary|Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
1215671|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
1215672|NCT00767806|Secondary|Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
1215673|NCT00767806|Primary|Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1215674|NCT00767767|Primary|GSR Trial 1|Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)|First Trial, for up to 1 day||||units on a scale||Standard Deviation|Mean
1215675|NCT00767676|Primary|Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale|"To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale [scale is 0 (no visible reaction) to 5 (severe erythema)]~No statistical analyses were performed."|7 weeks|Per protocol|||participants|||Number
1215676|NCT00767624|Secondary|Percentage of Participants in Insomnia Remission|Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.|16 weeks||||percentage of particpants in arm|||Number
1215677|NCT00767624|Primary|Percent of Participants With Depression Remission|"Depression remission was defined if both a and b below are satisfied~absence of both depressed mood and anhedonia for at least three consecutive weeks~no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks"|16 weeks||||percentage of participants in arm|||Number
1215678|NCT00767572|Primary|Pre-post Change in Brachial Artery Reactivity|Brachial artery reactivity was assessed by Flow-mediated dilatation (FMD), performed before and after the 12 week period on therapy. FMD uses high-frequency ultrasound measurement of changes in brachial artery diameter after a 5-minute blood pressure cuff arterial occlusion. Brachial artery reactivity has been shown to predict long-term cardiovascular events.|Baseline, 12 weeks|12 enrolled participants were randomly assigned to receive a 12-week course of either atorvastatin or placebo, followed by a 4-week washout, then 12 weeks on the alternate intervention.|||mm||Standard Deviation|Mean
1215679|NCT00767520|Secondary|Number of Participants With Abnormalities in Electrocardiograms||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||2013-05-31|05/2013||||
1215680|NCT00767520|Secondary|Number of Participants With Abnormalities in Vital Signs||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||2013-05-31|05/2013||||
1215681|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)|Grade (GR)1= mild, GR2= moderate, GR3= severe, GR4= life threatening. Ranges are provided by the local laboratory and may vary according to sex and age. Phosphorous, GR1:<LLN 2.5 mg/dL, GR2:<2.5–2.0 mg/dL, GR3: 1.0-<2.0 mg/dL; Low sodium,GR1:<LLN 130mmol/L, GR3:120-<130 mmol/L; High Magnesium, GR1 >ULN 3.0 mg/dL,GR 3:<0.3 0.8mg/dL; Uric acid, GR1:>ULN 10 mg/dL, GR4:>10 mg/dL; Low potassium, GR1:<LLN 3.0mmol/L,GR3:<3.0 2.5mmol/L; High potassium, GR1:>ULN–5.5 mmol/L, GR2:>5.5–6.0 mmol/L; Bicarbonate, GR1:<LLN–16 mmol/L; GR2:<16 – 11 mmol/L; Hig sodium, GR1:>ULN–150 mmol/L,GR2:>150–155 mmol/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
1215682|NCT00767520|Primary|Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs. Maximum participant PFS of ____ months)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.|||participants|||Number
1215683|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)|Grade (GR) 1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening). Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, GR 1: >ULN–2.5 x ULN (upper limit of normal), GR 2: >2.5–5.0 x ULN, GR 3: 5.0-20.0 x ULN; Low calcium, GR 1: <LLN – 8.0 mg/dL, GR 2: <8.0–7.0 mg/dL, GR 4:<6.0 mg/dL; High calcium, GR 1:>ULN – 11.5 mg/dL; bilirubin, GR 1: >ULN–1.5 x ULN,GR 3: >3-10 x ULN; Creatinine, GR1:>ULN–1.5 x ULN, GR2: >1.5–3.0 x ULN; Albumin, GR1:<LLN–3 g/dL,GR2:<3–2 g/dL.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
1215684|NCT00767520|Secondary|Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)|Abnormalities were graded per NCI-CTC, Version 3.0 criteria. Grade (GR)1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening. Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Granulocytes, GR 1;<LLN–1.5x 10^9/L, GR 2:<1.5–1.0x10^9/L, GR 3: <1.0 – 0.5x10^9/L, GR, 4: <0.5x10^9 /L; Hemoglobin, GR 1: <LLN–10.0 g/dL, GR 2: <10.0–8.0 g/dL, GR 3: <8.0–6.5 g/dL, GR, 4: <6.5g/dL; Platelets, GR 1: <LLN–75.0x10^9/L, GR 2: <75.0–50.0x10^9/L, GR 3: <50.0-25.0x10^9/L; Leukocytes, GR 1: <LLN–3.0x10^9/L, GR 2: <3.0–2.0x10^9/L, GR 4: <1.0x10^9/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
1215685|NCT00767520|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade (GR)1 = mild, GR 2 = moderate, GR 3=severe, GR 4=life threatening, GR 5=death.|From start of study drug therapy up to 30 days after the last dose. Median duration of therapy (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
1215686|NCT00767520|Secondary|Changes in Markers of Bone Lysis in Participants With Bone Metastasis|Assay for urinary N-telopeptide was used to evaluate Osteolytic activity.|Screening, Day 1, after week 2, 4, and week 8 and subsequently every 8 weeks, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||2013-05-31|05/2013||||
1215687|NCT00767520|Secondary|Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis|Pain intensity evaluated by administration of the Brief Pain Inventory - Short Form (BPI-sf). The BPI-sf is a psychometrically-validated instrument which measures both pain severity and functional interference caused by pain using an 11-point numerical rating scale. Severity of pain at its “worst”, “least” and “on average” in the last 24 hours, and “right now” (ie, at the time the questionnaire is being filled out) is recorded using anchors of “no pain” = “0” and “pain as bad as you can imagine” = “10”.|Start of study, at treatment start, after 2, 4, and 8 weeks of therapy and every 8 weeks thereafter, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||2013-05-31|05/2013||||
1215688|NCT00767520|Secondary|Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Duration of response is defined as the time from date that measurement criteria are first met for PR or CR until first date of documented PD or death. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer.||2013-05-31|05/2013||||
1215689|NCT00767520|Secondary|Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Time to response is defined as time from first dose of study therapy until measurement criteria are first met for PR or CR (whichever is recorded first). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until CR or PR. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer||2013-05-31|05/2013||||
1215690|NCT00767520|Secondary|Participants With Freedom-From-Progression (FFP) at 6 Months|FFP at month 6 is defined for the randomized participants who had the probability of neither progressing nor dying before 6 months.|at 6 months||2013-05-31|05/2013||||
1215734|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants|Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least one dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1215691|NCT00767520|Secondary|Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Response= Proportion of response-evaluable participants whose best response is CR or PR. Confidence intervals was computed using the Clopper-Pearson method. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant response was 39 weeks)|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||percentage of participants||95% Confidence Interval|Number
1215692|NCT00767520|Secondary|Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months|CB = participants whose best response is CR, PR, or stable disease(SD). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value). Confidence interval computed by Clopper-Pearson method.|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||percentage of participants||95% Confidence Interval|Number
1215693|NCT00767520|Secondary|Number of Participants With Best Overall Response|Complete response (CR) = Disappearance of all measurable and non-measurable lesions, and no new lesions; Partial response (PR) = Decrease ≥30% from baseline in sum of longest diameters (LD) of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value).|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||participants|||Number
1215694|NCT00767520|Primary|Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.|||weeks||95% Confidence Interval|Median
1215695|NCT00767507|Secondary|Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner||Through 7 days or hospital discharge, whichever was sooner||||patients|||Number
1215696|NCT00767507|Secondary|Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild||Randomization until start of CABG surgery|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.|||participants|||Number
1215697|NCT00767507|Secondary|Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding|Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of >1.5 liters (L), and/or packed red blood cell transfusions > 4 units|Randomization through Hospital discharge|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.|||Patients|||Number
1215698|NCT00767507|Secondary|Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU|"This endpoint analyzed the percent of patients with platelet reactivity < 240 PRU at the following timepoints:~Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition)~Last sample during infusion~Following discontinuation of study drug infusion"|baseline until just prior to surgery (post infusion)||||percent of patients|||Number
1215699|NCT00767507|Primary|Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.|"This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events.~Patients had multiple samples and all on-infusion samples had to be <240 PRU to meet the endpoint."|During study drug infusion up to 1-6 hours prior to surgery|"Based on available data from ITT population; ITT population (Cangrelor N = 93) / (Placebo N = 90).~Valid PRU results were not available during the infusion period for 15 patients (9 cangrelor and 6 placebo)."|||Percent of patients|||Number
1215700|NCT00767507|Primary|Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.|Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).|During study drug infusion up to 1-6 hours prior to surgery||||percentage of samples|Participants||Number
1215735|NCT00766831|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score|The CGI-Improvement score evaluates how much the participant’s condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1215701|NCT00767455|Primary|Presence of Cumulative Irritation|Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).|22 days|Per protocol|||units on a scale|||Number
1215702|NCT00767364|Secondary|Serum Anti-rotavirus IgA Level Post-vaccination|Serum anti-rotavirus IgA level was measured post-vaccination in all subjects|6 months from the first vaccination date||||U/ml|||Number
1215703|NCT00767364|Primary|Safety and Tolerability of the Oral RotaTeq® Vaccine|Adverse events and patient tolerance of vaccine doses 1 - 3 for all infants participating in the study were recorded.|12 months from the first vaccination date||||Individual Adverse Events|||Number
1215704|NCT00767338|Primary|Number of Live Births After Eight Cycles of Infertility Treatment.||January 2009 to January 2012|The participants analyzed correspond to the number of participants who completed the study. In two of the arms, the study was terminated before participants were randomized to those arms.|||participants|||Number
1215705|NCT00767325|Secondary|Number of Participants With Adverse Events (AEs) of Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Infusion reaction: acute=1 hour or less after start of dosing; periinfusional=24 hours or less after start of dosing.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.|||Participants|||Number
1215706|NCT00767325|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events(SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.|||Participants|||Number
1215707|NCT00767325|Secondary|Number of Early (Days 7 to 113) Global PDUS MCP 2-5 Scores or Global PDUS Component MCP 2-5 Scores Associated With an Acceptable Predictability of Clinical Response at Day 169, As Assessed by DAS28-CRP|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography; DAS=Disease Activity Score;CRP=C-reactive protein. Receiver Operator Characteristics (ROC) analysis assessed predicatability. ROC curve analyses performed; area under the curve of ≥0.7 was considered acceptable for prediction. Clinical response defined as: Clinically Meaningful Improvement=drop from baseline of ≥1.2 in DAS28-CRP; Remission=DAS28-CRP score <2.6; Low Disease Activity=≤3.2. PDUS scores: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH with ≤Gr 2 Doppler signal or minimal SH and Gr 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint rated 1-3, for a total possible score ranging from 8-24 (8*1, 8*3)for the 2 hands. Higher gr/score=more severe disease.|Days 1 to 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Scores|||Number
1215708|NCT00767325|Primary|Earliest Time Point at Which Improvement of Core Component of the Global PDUS in the MCP (2-5) Joints of Both Hands Was Assessed|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography. Time point at which early signs of Global PDUS improvement were observed=earliest time point for which 0 was not included in the 95% confidence interval for the mean changes from baseline in Global PDUS (MCP 2-5) score at that and all later time points. Total PDUS scores are independent of the presence and grade of joint effusion: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH, with ≤Gr 2 Doppler signal or minimal SH and grade 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher Gr/score=more severe disease.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Day|||Number
1215709|NCT00767325|Secondary|Mean Change From Baseline in Global PDUS MCP 2-5 Component Scores Over Time (LOCF Analysis)|PDUS=power Doppler ultrasonography; MCP=metacarpophalangeal; LOCF=last observation carried forward. PDUS was used to assess the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and grade 2 Doppler signal); Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤ Grade 3 Doppler signal or minimal or 1-3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher grade/score=more severe disease. Change=score Day X-baseline score.|Days 7, 15, 29, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Units on a scale||Standard Error|Mean
1215747|NCT00766753|Primary|Number of Participants Who Experienced Treatment-related Dose Limiting Toxicities (DLT)|Number of participants who experienced treatment-related Dose Limiting Toxicities (DLT) at any dose level.|up to 8 weeks|Participants at any dose level, through the first booster phase.|||Participants|||Count of Participants
1215710|NCT00767325|Primary|Mean Change From Baseline in Global Power Doppler Ultrasonography (PDUS) Score Assessing the Metacarpophalangeal (MCP) 2-5 Joints of Both Hands (LOCF Analysis)|LOCF=last observation carried forward. PDUS assessed the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. Total PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and Grade 2 Doppler signal; Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤Grade 3 Doppler signal or minimal or moderate synovial hypertrophy and Grade 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for 2 hands. Higher grade/score=more severe disease. Change=score Day x - baseline score.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Units on a scale||95% Confidence Interval|Mean
1215711|NCT00767104|Secondary|% Reduction in Total Lesion Count|.This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.|12 weeks||||% reduction in total lesion count||95% Confidence Interval|Mean
1215712|NCT00767104|Primary|Total Lesion Count|The number of papules, pustules and cysts at Week 12.|12 weeks|Number of participants in each group|||lesions||95% Confidence Interval|Mean
1215713|NCT00767039|Secondary|Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.|Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.|NICU hospitalization, up to 42 weeks post menstrual age|All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at > 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied.|||Subjects with BPD + Neonatal Deaths||90% Confidence Interval|Number
1215714|NCT00767039|Secondary|Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)|Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.|36 weeks post menstrual age|Population analyzed was limited to those subjects who survived to >36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at >36 weeks post menstrual age) were tallied.|||Surviving Subjects with BPD||90% Confidence Interval|Number
1215715|NCT00767039|Secondary|Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant|Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.|One hour following second surfactant dose at 12-24 hours after initial dose|The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration.|||Percent change from baseline velocity||Standard Error|Mean
1215716|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20-Percent of O2||Standard Error|Mean
1215717|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20-Percent of O2||Standard Error|Mean
1215718|NCT00767039|Secondary|Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)|Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.|First hour after 2nd surfactant dose|Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data.|||cc/min||Standard Error|Mean
1215748|NCT00766675|Secondary|Number of Participants With Subject's Global Assessment|Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
1215719|NCT00767039|Secondary|Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)|Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.|Hemodynamically significant PDA at > 2 days|Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at >3 days, were tallied|||Subjects||90% Confidence Interval|Number
1215720|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|72 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.|||Participants successfully extubated||90% Confidence Interval|Number
1215721|NCT00767039|Primary|Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20||Standard Error|Mean
1215722|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|48 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.|||Participants successfully extubated||90% Confidence Interval|Number
1215723|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20||Standard Error|Mean
1215724|NCT00767000|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event||Entire study including 54-week study and 104-week extension||||percentage of participants|||Number
1215725|NCT00767000|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Entire study including 54-week study and 104-week extension|Full analysis set. Includes additional participants enrolled in the MK-0941 40 mg and placebo groups to enhance evaluation of the safety profile of MK-0941.|||percentage of participants|||Number
1215726|NCT00767000|Secondary|Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%||Weeks 54, 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158||||||
1215727|NCT00767000|Secondary|Percentage of Participants Who Achieve an HbA1c of <7.0%||Weeks 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158||||||
1215728|NCT00767000|Secondary|Change in the Fasting Plasma Glucose Level|Least squares mean change from baseline in fasting plasma glucose.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1215729|NCT00767000|Secondary|Change in the Two-hour Post Meal Glucose Level|Least squares mean change from baseline in 2-hour post meal glucose level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1215730|NCT00767000|Primary|Change in Hemoglobin A1c (HbA1c) Level|Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||Percent HbA1c||95% Confidence Interval|Least Squares Mean
1215731|NCT00766831|Secondary|Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug|"Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were I experienced a certain pain relief effect during the administration of the drug, I didn’t wake up due to pain while sleeping, It was more convenient because the number of administrations was reduced, I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain and other."|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Percentage of participants|||Number
1215732|NCT00766831|Secondary|Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug|Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.|Day 15|ITT population included all the participants who received at least one dose of study medicaation and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.|||Percentage of participants|||Number
1215736|NCT00766831|Secondary|Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score|The ECOG performance status was used to evaluate participant’s disease progression and the effect of the disease on the participant’s activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1215737|NCT00766831|Secondary|Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain|The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'N' signifies participants who were evaluated for this outcome measure.|||Frequency of breakthrough pain drug||Standard Deviation|Mean
1215738|NCT00766831|Secondary|Participant’s Pain Intensity|Participant’s pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Units on a scale||Standard Deviation|Mean
1215739|NCT00766831|Secondary|Korean Brief Pain Inventory (K-BPI) Questionnaire Score|K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies the number of participant who were evaluated for particular category at particular time point.|||Units on a scale||Standard Deviation|Mean
1215740|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain|"The Investigator evaluated sleep disturbance through the participant’s answers to below question in yes or no response: ‘Did you wake up because of unbearable pain this morning?’"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1215741|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Frequency of Waking Up|The Investigator evaluated sleep disturbance through the participant’s answers to below question: How many times did you wake up while sleeping late night (frequency [once, 2 times, 3 times, 4 times, 5 times, couldn’t fall asleep at all] of waking up due to pain last night).|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies participants who were evaluated for this outcome measure at a particular time point.|||Participants|||Number
1215742|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Analgesic Administration|"The Investigator evaluated sleep disturbance through the participant’s answers to below question in yes or no response: ‘Did you need to take an analgesic for pain relief in order to go to sleep last night?’"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1215743|NCT00766831|Primary|Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain|Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.|Day 15 or Early withdrawal|Intent to treat (ITT) population included all the participants who received study medication at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.|||Percentage of treatment response||95% Confidence Interval|Number
1215744|NCT00766753|Secondary|Overall Survival (OS)|Time interval from start of treatment until date of death.|Up to 102 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||months||90% Confidence Interval|Median
1215745|NCT00766753|Secondary|12-month- Progression Free Survival (PFS)|Number of patients with progression-free status lasting at least 12 months|Up to 12 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||participants|||Number
1215746|NCT00766753|Primary|Median Time To Progression|Median number of months until disease progression. Tumor size was assessed using magnetic resonance imaging (MRI) scans with contrast enhancement to detect change from baseline.|At baseline, 9, 17, 25, and 33 weeks, and every 3 months; up to 23 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||months||Full Range|Median
1215749|NCT00766675|Secondary|Number of Participants With Physician Global Assessment|The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
1215750|NCT00766675|Secondary|Total Fibromyalgia Impact Questionnaire (FIQ) Score|The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.|Baseline and Day 56|"The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."|||Units on a scale||Standard Deviation|Mean
1215751|NCT00766675|Secondary|Participant Assessment Sleep Questionnaire Score|Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to “How often during past 4 weeks did participant felt” and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1215752|NCT00766675|Secondary|Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept|The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant’s sleep habits out of which Q1 was “How long did it usually take for participant to fall asleep during the past 4 weeks” and Q2 was “On the average, how many hours did participant sleep each night during the past 4 weeks”.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Hours||Standard Deviation|Mean
1215753|NCT00766675|Secondary|Tender-Point Evaluation/ Myalgic Score|Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1215754|NCT00766675|Secondary|Number of Participants With Categorical Scores on Pain Relief Rating Scale|Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
1215755|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 56|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
1215756|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 28|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 28|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
1215757|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 14|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 14|Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
1215758|NCT00766649|Secondary|Change in Photoreceptor Outer Segment (PROS) Thickness as Measured by Optical Coherence Tomography at 24 Months as Compared to Baseline||Baseline and Month 24|||||||
1215759|NCT00766649|Secondary|Change in Drusen Volume as Measured by Optical Coherence Tomography (OCT) at 24 Months as Compared to Baseline||Baseline and Month 24|||||||
1215760|NCT00766649|Secondary|Change in Total Area of Drusen in the Fellow Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
1215761|NCT00766649|Secondary|Change in Total Area of Drusen in the Study Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
1215762|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24||||MPS DA/month||Standard Deviation|Mean
1215764|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the fellow eye at 24 months by the baseline value.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline and Month 24||||Ratio|Participants|Standard Deviation|Mean
1215765|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 24 months by the baseline value.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline to Month 24||||Ratio|Participants|Standard Deviation|Mean
1215766|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the fellow eye at baseline from the GA value for the study eye at Month 24.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
1215767|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 24.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
1215768|NCT00766649|Secondary|Number of Study Eyes With a 15 Letter Drop From Baseline at 24 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Month 24||||eyes|Participants||Number
1215769|NCT00766636|Primary|Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.|Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report|Following resection performed at time of surgery, day 36 of treatment +/- 5 days|The study was terminated early without enough patients to perform any analysis between the groups. Of the five registered, one withdrew prior to any treatment and the others either had disease progression or left prior to surgery with incomplete preoperative regimen.||||||
1215770|NCT00766597|Secondary|Change in Plasma HIV RNA PCR|Changes in HIV RNA (copies/mL) from baseline to Week 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1215771|NCT00766597|Secondary|Change in Polymerase Genome and Envelope Sequence|Number of subjects with changes in genotypic and phenotypic drug resistance to the OBT and to vicriviroc (envelope sequence) from baseline to Week 24 and/or virologic failure will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1215772|NCT00766597|Secondary|Change in CD4 Percent|Change in CD4 percent from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1215773|NCT00766597|Secondary|Change in CD4 Counts|Change in CD4 count from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1215774|NCT00766597|Secondary|Number of Participants With Changes in Co-receptor Tropism From Baseline|Among all patients enrolled in Step I, the prevalence of detectable coreceptor phenotype, R5 tropic, R5/X4 mixed and X4 tropic viruses will be evaluated. The extent to which coreceptor phenotype in Step I is associated with Step I CD4 cell count, HIV RNA, and age will be evaluated. The association of Step I coreceptor phenotype and nadir CD4, HIV subtype, number of ART regimens, and years of ART will be evaluated. At the time of virologic failure, the extent of change from Step I and/or baseline R5 tropic virus to R5/X4 mixed or to X4 tropic virus as detected by the TrofileTM assay will be evaluated.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1215775|NCT00766597|Secondary|Number of Participants Who Failed to Achieve =>1-log Drop From Baseline in HIV-1 Viral Load and HIV-1 Viral Load of =>400 Copies/mL (Virologic Failures)|Plasma HIV RNA (RNA) concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular). The primary definition of virologic success will require subjects to have achieved and maintained 1-log drops from baseline of HIV-1 RNA or HIV-1 RNA <400 copies/mL.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1215776|NCT00766597|Primary|Number of Participants Who Failed to Meet PK Targets|For Stage I subjects who are enrolled in Step II, the average of the pre-dose and 24 hour post dose sample from the intensive PK evaluations of said subjects will be used as the estimate of Cmin. The whole cohort will fail the PK targets if the population target (median vicriviroc Cmin should be =>200 ng/mL) is not met, and that nearly all of subjects’ Cmin failed to be > 100 ng/mL.|At Week 24|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II and who failed the PK targets. Outcome measure not analyzed since the PK targets were for the whole cohort, but the lone cohort opened was not fully enrolled due to early study termination.||||||
1215777|NCT00766597|Primary|Number of Participants With Adverse Events of Grade 3 or Higher Severity|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II|||participants|||Number
1215778|NCT00766597|Primary|Number of Participants With Suspected Adverse Drug Reaction Leading to Treatment Termination|The protocol required reporting of signs and symptoms and laboratory abnormalities of >=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules is to be determined by the Study Team. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR5-tropic virus who started treatment in Step II.|||participants|||Number
1215779|NCT00766532|Primary|Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy|intestinal calcium absorption|baseline and 6 weeks later|12 subjects provided informed consent but two dropped and did not undergo calcium absorption study visits. 10 subjects completed all calcium absorption study visits.|||percent calcium absorption||Standard Deviation|Mean
1215780|NCT00766506|Other Pre-specified|Number of Participants Facing Technical Failure of the Device|Technical failure was defined as malfunctioning or failure of device to work appropriately.|Baseline up to end of study treatment (Hour 72)|Safety population included all participants randomly assigned to study treatment and who used either of the study treatment at least once.|||Participants|||Number
1215781|NCT00766506|Secondary|Number of Participants Who Require Concomitant Non-opioid Analgesics|Non-opioid analgesics are non morphine like medications used to get relieve from pain.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
1215782|NCT00766506|Secondary|Number of Participants Who Require Concomitant Antiemetic Medication|Antiemetic medicines are the drugs which prevent vomiting.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
1215783|NCT00766506|Secondary|Number of Participants Who Require Rescue Medication|Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group.|Baseline up to Hour 3|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
1215784|NCT00766506|Other Pre-specified|Time to Actual Discharge|The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.|When participant was actually discharged from ward care (assessed up to 258.5 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Hours||95% Confidence Interval|Median
1232655|NCT00640224|Secondary|Delta Androstenedione at Baseline and 6 Months|Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.|Baseline and 6 months||||ng/dL||Standard Error|Mean
1215785|NCT00766506|Secondary|Time to Fit For Discharge (FFD)|Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a “Yes” or “No” basis. When all criteria were answered as Yes, participant was considered to be FFD.|When participant was FFD (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Hours||95% Confidence Interval|Median
1215786|NCT00766506|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: “Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?”|Hour 72 or early study withdrawal|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1215787|NCT00766506|Secondary|Nurse Ease of Care (EOC) Questionnaire Score|Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from ‘not at all’ (Score 0) to ‘a very great deal’ (score 5). The total score was calculated as the mean of the non-missing items for all the questions.|When participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Units on scale||95% Confidence Interval|Least Squares Mean
1215788|NCT00766506|Secondary|Pain Intensity Numerical Rating Scale (NRS)|Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant’s pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now.|Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Unit on Scale||Standard Deviation|Mean
1215789|NCT00766506|Primary|Participant’s Evaluation of Mean Ability to Mobilize After Surgery|The ability to mobilize was assessed through a combined analysis of participant’s responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from “not at all” (score 0) to “a very great deal” (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).|Hour 72 or early study withdrawal|The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Units on scale||Standard Deviation|Mean
1215790|NCT00766493|Secondary|Neurologic Events|Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).|30 days||||Participants|||Number
1215791|NCT00766493|Secondary|Access Site Complications|Access Site Complications defined as the presence of a large hematoma (>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.|30 days||||Participants|||Number
1215792|NCT00766493|Secondary|Clinical Success|Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.|30 days||||Participants|||Number
1215793|NCT00766493|Secondary|Device Success|Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).|Post Procedure||||Participants|||Number
1215794|NCT00766493|Primary|Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure||30 days|EMBOLDEN subjects evaluable for the primary endpoint|||Participants|||Number
1215795|NCT00766467|Secondary|Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment|To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment.|56 days|Grade 3 - 4 events at least possibly related to study treatment.|||number of incidents|||Number
1215796|NCT00766467|Secondary|Change From Baseline in Quality of Life at Days 22, 43 and 56|The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life.|baseline, day 22, day 43, and day 56|Analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.|||units on a scale||80% Confidence Interval|Median
1216221|NCT00763867|Other Pre-specified|Best Available Creatinine|Best available=local lab results only when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1215797|NCT00766467|Primary|Change From Baseline in Fatigue at Day 43|The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score < 30 indicates severe fatigue.|43 days|Primary analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.|||units on a scale||80% Confidence Interval|Median
1215798|NCT00766415|Secondary|Adverse Event (AE)|Number of participants with an Adverse Event|1 month||||Participants|||Number
1215799|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1215800|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score|Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1215801|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1215802|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score|Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1215803|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Evening|Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||95% Confidence Interval|Mean
1215804|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Morning|Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||95% Confidence Interval|Mean
1215805|NCT00766415|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)|Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||95% Confidence Interval|Mean
1215806|NCT00766415|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage change||95% Confidence Interval|Mean
1215807|NCT00766415|Primary|Induced Sputum: Total Cells Count|Change in Induced sputum Total cells count from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||10^6/g||95% Confidence Interval|Mean
1215808|NCT00766415|Primary|Induced Sputum: Epithelial Cells Count (%)|Change in Induced sputum Epithelial cells count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215809|NCT00766415|Primary|Induced Sputum: Lymphocytes Count (%)|Change in Induced sputum Lymphocytes count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215810|NCT00766415|Primary|Induced Sputum: Macrophages Count (%)|Change in Induced sputum Macrophages count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1216358|NCT00762762|Primary|HbA1c Levels in Blood|Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.|12 months||||percentage of HbA1c levels||Standard Deviation|Mean
1215812|NCT00766415|Primary|Induced Sputum: Eosinophil Count (%)|Change in Induced sputum Eosinophil count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215813|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Total Cells Count|Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||10^6/g||95% Confidence Interval|Mean
1215814|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)|Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215815|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)|Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215816|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Macrophages Count (%)|Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215817|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Neutrophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215818|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Eosinophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1215819|NCT00766415|Primary|Aggregated Pathology Score|Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1215820|NCT00766376|Secondary|Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.|To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.|participants at three months||||Participants|||Number
1215821|NCT00766376|Primary|Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.|To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.|participants at three months||||Participants|||Number
1215822|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])|Rivastigmine PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for rivastigmine after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||h*ng/mL||Standard Deviation|Mean
1215823|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)|Rivastigmine PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||hours||Standard Deviation|Mean
1215824|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)|Rivastigmine PK data; Maximum Concentration (Cmax); i.e, highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||ng/mL||Standard Deviation|Mean
1215825|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])|Donepezil PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for donepezil (parent compound only) after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||h*ng/mL||Standard Deviation|Mean
1216095|NCT00764790|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1215826|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)|Donepezil PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||hours||Standard Deviation|Mean
1215827|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)|Donepezil PK data; Maximum Concentration (Cmax); i.e, highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||ng/mL||Standard Deviation|Mean
1215828|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])|EVP-6124 PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||h*ng/mL||Standard Deviation|Mean
1215829|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)|EVP-6124 PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||hours||Standard Deviation|Mean
1215830|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)|EVP-6124 PK data; Maximum Concentration (Cmax); i.e, highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||ng/mL||Standard Deviation|Mean
1215831|NCT00766363|Primary|Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer’s Disease|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood chemistry/urinalysis)|Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only]|Safety Population: All randomized subjects who ingested at least 1 dose of study drug.|||Participants|||Number
1215832|NCT00766090|Secondary|Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods|Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population|||participants|||Number
1215833|NCT00766090|Secondary|Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period|Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
1215834|NCT00766090|Secondary|Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1215835|NCT00766090|Secondary|Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period|Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1215836|NCT00766090|Secondary|24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period|A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.|Day 28 of the relevant treatment period (up to Study Day 112)|Urine Cortisol (UC) Population: participants who had both a Baseline urine sample and at least one urine sample from the end of a treatment period that did not have confounding factors that could affect the interpretation of results|||Nanomoles per 24 hours||Geometric Coefficient of Variation|Geometric Mean
1215837|NCT00766090|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population|||participants|||Number
1215847|NCT00765947|Primary|Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks|Full analysis set|||Percentage of participants|||Number
1215838|NCT00766090|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.|Day 28 of the relevant treatment period (up to Study Day 112)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication|||Liters||Standard Error|Least Squares Mean
1215839|NCT00766051|Secondary|"A Priori H4: A Total Scale Score of Parents' Perception of Infant Easiness (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Easiness Scale measures the parent's perceived efficacy in the areas of infant irritability, sleeping habits, alertness and responsiveness, and difficulty. The Easiness Scale(Wolke [in Brazelton and Nugent], 1995]) was used to determine mother/parent perceptions of their infants' mood and state in the NICU as a result of training in NBOTI. An increasing score denotes an improvement in parent efficacy in their perception of their infant's easiness.uses a Likert scale. There are four questions, ranging from -3-3. The maximum score is 12, and the minimum score is -12.|Upon an infant's entry into the study, and again at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.|||Scores on Scale||Standard Deviation|Mean
1215840|NCT00766051|Secondary|"A Priori H3: A Total Score of the Parents' Global Confidence (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Global Confidence Scale of The Mother and Baby Scales (Wolke [in Brazelton and Nugent], 1995]) is a total score measure of mother/parent self efficacy in the NICU as a result of training in NBOTI. It is a total score measure of the parent's perceived efficacy of themselves as confidence in the feeding, handling, caretaking, and interactions needed to foster relationships with their infants. An increase in this score denotes an increase in the parent's perception of their global confidence in caring for their infant. Global Confidence Measure uses a Likert scale. There are three questions, ranging from -3-3. The maximum score is 9, and the minimum score is -9.|Upon an infant's entry into the study, and at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.|||scores on scale||Standard Deviation|Mean
1215841|NCT00766051|Secondary|A Priori H2: The Increase in Oral Feeding Percentage Over Days Was Correlated With Increasing Respiratory Competency During Oral Feeding; Measured as the High Frequency Percentage (HF%) of Intervention Groups' Heart Rate Variability (HRV) During Feeding.|Oral feeding percentage was based upon 150 kc/kg/day. Heart rate data was recorded about once per week during feeding using a Holter monitor connected to the bedside ecg. This data was downloaded in Cardiology, converted to numerical data as HRV by bioengineers at Politecnico di Milano, Italy. As infants reached 100% of oral feedings, heart rate variability data was analyzed to determine the infants' overall trend toward relaxation, measured as increasing High Frequency Percentage (HF %). Hierarchical linear modeling (HLM) (Singer and Willett, 2003) SPSS Grad Pack 17, mixed model analysis.|The time frame was from Baseline until discharge (at or before 20 days).|The intervention group consisted of Four Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, and Two near term infants with Omphalocele. This outcome measured the correlation between the percentage of oral feedings and the percentage of High Frequesncy Heart Rate Variability.|||Percentage||Standard Deviation|Mean
1215842|NCT00766051|Primary|A Priori H1. The Number of Days to Achieve Oral Feeding Between the Intervention Group and the Matched Historical Comparison Group - From All Tube to All Oral Feeding - Was Analyzed.|This outcome measured the number of days it took to go from all tube to all oral feeding or at discharge, whichever came first. Oral feeding percentages were based upon 150 kcal/kg/day. Feeding volumes and weights were taken directly from the nurses notes, and averaged daily. A two sample t-test was used to detect differences between the groups.|The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).|The intervention group and matched historical comparison group consisted of Four pairs of Extremely Preterm to Preterm infants with high risk factors, Three pairs of term or near term infants with Gastroschisis, Two pairs of infants term or near term with Omphalocele, and One pair of infants term age with Congenital Diaphragmatic Hernia.|||Days||Standard Deviation|Mean
1215843|NCT00765947|Secondary|Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment||24 weeks|||||||
1215844|NCT00765947|Secondary|Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]|Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics).|24 weeks||||Percentage of Participants|||Number
1215845|NCT00765947|Secondary|Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]||Baseline and Week 24|Full analysis set|||mm Hg||Standard Deviation|Mean
1215846|NCT00765947|Secondary|Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks||||Percentage of Participants|||Number
1215861|NCT00765817|Secondary|Change in Systolic Blood Pressure (SBP)|Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmHg||Standard Error|Least Squares Mean
1215848|NCT00765895|Primary|Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits|A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.|at end of treatment, 15 weeks from baseline assessment|intention to treat|||participants||95% Confidence Interval|Number
1215849|NCT00765882|Secondary|12-Week Constipation Severity|Constipation severity was based on a 5-point ordinal scale where a value of l is “none” and a value of 5 is “very severe”.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 11 additional patients who dropped out prior to finishing 1 week of the trial were excluded from the Constipation Severity endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1215850|NCT00765882|Secondary|12-Week Bloating|Bloating was based on a 5-point scale where a value of l is “none” and a value of 5 is “very severe”.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 1 additional patient without a baseline Bloating score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1215851|NCT00765882|Secondary|12-Week Abdominal Discomfort|Abdominal discomfort is based on a 5-point scale where a value of l is “none” and a value of 5 is “very severe.”|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. 1 additional patient without a baseline Abdominal Discomfort score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1215852|NCT00765882|Secondary|12-Week Severity of Straining|Straining is measured on a 5-point scale, where a value of 1 is “not at all” and a value of 5 is “an extreme amount.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 Patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1215853|NCT00765882|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1215854|NCT00765882|Secondary|12-Week Spontaneous Bowel Movement (SBM) Frequency Rate|A patient’s 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||SBM per week||Standard Error|Least Squares Mean
1215855|NCT00765882|Secondary|12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||CSBM per week||Standard Error|Least Squares Mean
1215856|NCT00765882|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.~A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1215857|NCT00765843|Primary|Heel Pain|Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.|baseline, one month and three months||||score on a survey||Standard Deviation|Mean
1215858|NCT00765817|Secondary|Percentage of Subjects Experiencing Minor Hypoglycemia|Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set|||percentage|||Number
1215859|NCT00765817|Secondary|Minor Hypoglycemia Rate Per Year|Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set|||events per subject per year||Standard Deviation|Mean
1215860|NCT00765817|Secondary|Change in Diastolic Blood Pressure (DBP)|Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmHg||Standard Error|Least Squares Mean
1215862|NCT00765817|Secondary|Change in Daily Insulin Dose (on a Per Body Weight Basis)|Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||insulin units per kg (U/kg)||Standard Error|Least Squares Mean
1215863|NCT00765817|Secondary|Change in Daily Insulin Dose|Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||insulin units (U)||Standard Error|Least Squares Mean
1215864|NCT00765817|Secondary|Change in Waist Circumference|Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||cm||Standard Error|Least Squares Mean
1215865|NCT00765817|Secondary|Change in Body Weight|Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||kg||Standard Error|Least Squares Mean
1215866|NCT00765817|Secondary|Change in Triglycerides|Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)|baseline and 30 weeks|Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1215867|NCT00765817|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
1215868|NCT00765817|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1215869|NCT00765817|Secondary|Change in Total Cholesterol|Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1215870|NCT00765817|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1215871|NCT00765817|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1215872|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.|||percentage|||Number
1215873|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.|||percentage|||Number
1215874|NCT00765817|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.|baseline and 30 weeks|Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||percentage of hemoglobin||Standard Error|Least Squares Mean
1215875|NCT00765765|Primary|Tumor Response Rate|Overall Complete Response and Partial Response will be considered tumor response. Ixabepilone as a single agent (40 mg/m2 as an intravenous infusion every 3 weeks) was evaluated in a previous (Phase II) study in women with metastatic breast cancer and that the objective tumor response rate was 11.5%. In another(Phase III) study, Ixabepilone in combination with capecitabine resulted in an objective tumor response rate of 35%, compared to that of capecitabine alone (14%). Therefore, in the Phase II portion of the ixabepilone plus hydroxychloroquine combination treatment study, a tumor response rate of less than 15% will be deemed uninteresting. The target tumor response rate will be 35%. Due to uncertainty about the true response rate of ixabepilone plus hydroxychloroquine combination on this patient poupation, we also will consider a response rate of 30% to be encouraging.|3 years|The study was closed early due to slow accrual. Insufficient data were collected to evaluate this outcome measure.||||||
1215876|NCT00765765|Secondary|Correlation of Estrogen Receptor, Progesterone Receptor and/or HER2 Status With Treatment Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
1215882|NCT00765726|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.|Month 24 or early withdrawal|Safety analysis population included all enrolled participants who had taken at least 1 dose of the study medication.|||Percentage of participants||95% Confidence Interval|Number
1215883|NCT00765674|Secondary|Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)|Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
1215884|NCT00765674|Secondary|Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)|Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|End of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||Percentage of patients|||Number
1215885|NCT00765674|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
1215886|NCT00765674|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
1215887|NCT00765661|Secondary|Evaluation of Safety and Efficacy of LCP-Tacro Compared to Prograf in Adult de Novo Kidney Transplant Patients.|"To evaluate the efficacy and safety of LCP-Tacro compared to Prograf in the first 12 months after kidney transplantation.~Efficacy was assessed by monitoring biopsy-proven acute rejection (BPAR) according to the Banff criteria, graft failure (defined by a patient starting dialysis for at least 30 days, nephrectomy, retransplantation, or death with a functioning graft), patient survival, and renal function based on serum creatinine and glomerular filtration rate (GFR), based on serum creatinine, serum urea nitrogen, and serum albumin."|12 months|All patients receiving at least one dose of study drug was included in the safety evaluation.|||participants|||Number
1215888|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.|||ng*hr/mL||Standard Deviation|Mean
1215889|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.|||ng/mL||Standard Deviation|Mean
1215890|NCT00765661|Primary|Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients.|Comparison of the proportion of patients achieving sufficient tacrolimus whole blood trough levels (7 to 20 ng/mL) during the first 14 days post-transplantation|14 days||||percentage of patients|||Number
1215891|NCT00765648|Secondary|Transition Time to Oral Medication|The median transition time (in hours) to oral medication|6 hours|these are the correct participant numbers for this secondary analysis|||hours||Inter-Quartile Range|Median
1215892|NCT00765648|Secondary|Subjects Requiring the Use of Intravenous Rescue Medications|The percent of subjects requiring the use of intravenous rescue medications|6 hours||||percentage of participants|||Number
1215893|NCT00765648|Secondary|Treatment Failure|Treatment failure is defined as admission to the hospital or observation unit for BP management|6 hours|these are the correct participant numbers for this secondary analysis|||percentage of participants|||Number
1215894|NCT00765648|Secondary|Emergency Department(ED)Time to Disposition Decision|Median number of hours from hospital admission until Emergency Department(ED)disposition|6 hours|these are the correct participant numbers for this secondary analysis|||hours||Inter-Quartile Range|Median
1215895|NCT00765648|Secondary|Average Number of Dose Titrations Within 30 Minutes|Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group|30 minutes||||number of titrations||Standard Deviation|Mean
1215896|NCT00765648|Primary|Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.|Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.|30 minutes after initiation of therapy|Intent to treat cohort.|||percentage of participants|||Number
1215897|NCT00765570|Secondary|Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.|Complete response (CR) = 100% tumor disappearance Partial response (PR) = > 50% reduction in size Stable disease (SD) = < 50% reduction or no change +/- 10% increase in tumor size Progressive disease (PD) = > 10% increase in size of tumor Unknown Status (UK)|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.||||participants|||Number
1215898|NCT00765570|Primary|Protocol Treatment Related Morbidity|Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.||||events|||Number
1215899|NCT00765388|Secondary|Changes in Skin Compared to Before Study|The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product|4 weeks|ITT population|||Participants|||Number
1215900|NCT00765388|Secondary|Bag Twisting During Night|The patient was asked if he/she noticed whether the bag twisted during night|4 weeks|ITT population|||Participants|||Number
1215901|NCT00765388|Secondary|Problems With Splashing Sounds During Use|The patient was asked whether he/she noticed any splashinh sounds during use|4 weeks|ITT population|||Participants|||Number
1215902|NCT00765388|Secondary|Feeling of Security During the Night|The patients feeling of security with the product during the night|4 weeks|ITT population|||Participants|||Number
1215903|NCT00765388|Secondary|Feeling of Security During the Day|The patients feeling of security with the bag during the day|4 weeks|ITT population|||Participants|||Number
1215904|NCT00765388|Secondary|Awareness of the Presence of the Product|Evaluates the patients awareness of the presence of the product during use.|4 weeks|ITT population|||Participants|||Number
1215905|NCT00765388|Secondary|Flexibility of the Product|Evaluation of the ability of the bag to conform with the patients movements (flexibility)|4 weeks|ITT population|||Participants|||Number
1215906|NCT00765388|Secondary|Adhesives Ability to Absorb Perspiration|Evaluation of the adhesives ability to absorb perspiration from the skin|4 weeks|ITT population|||Participants|||Number
1215907|NCT00765388|Secondary|Adhesion of the Bag During Use|Evaluation of the adhesion of the base plate around the stoma during use|4 weeks|ITT population|||Participants|||Number
1215908|NCT00765388|Secondary|Removal of the Bag|How easy/difficult it was to remove the bag|4 weeks|ITT population|||Participants|||Number
1215909|NCT00765388|Secondary|Immediate Adhesion|Evaluation of immediate adhesion after each period|4 weeks|Intention to treat (ITT)|||Participants|||Number
1215910|NCT00765388|Primary|Preference of Sensura vs Moderma|Subjects were asked which of the tested products they preferred; SenSura or Moderma.|4 weeks||||percentage of prefering the product|||Number
1215911|NCT00765375|Primary|Change in Mean Lesion Count From Baseline at 90 Days|To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)|Baseline and 90 days|All subjects completing Day 90 visit|||Lesions||Standard Deviation|Mean
1215912|NCT00765362|Primary|Knee Society Scores Used as Success/Failure Criteria.|The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Percentage of Participants with Success|||Number
1215913|NCT00765362|Primary|Knee Society Function Score|The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Average Knee Function Score||Standard Deviation|Mean
1215914|NCT00765362|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Average Knee Rating Score||Standard Deviation|Mean
1215915|NCT00765336|Primary|Mean Percent Change From Screening in Sperm Concentration.||Baseline and 12 Weeks|The enrollment was designed to ensure study completion of approximately 150 subjects. Actual enrollment was 180 subjects (92 in the minocycline group, 88 in the placebo group). A total of 145 subjects (72 in the minocycline group, 73 in the placebo group) comprised the completed population group.|||Percent change||Standard Deviation|Mean
1215916|NCT00765245|Other Pre-specified|Exploratory: Concordance Between IHC for GCB and Non-GCB Subtypes to the Gene Expression Profiles Associated With the Subtypes||up to two years|||||||
1215917|NCT00765245|Other Pre-specified|Investigate Potential Predictive Biomarkers of Clinical Response or Resistance to Lenalidomide||up to two years|||||||
1216220|NCT00763867|Other Pre-specified|Best Available Glomerular Filtration Rate (GFR)|Best available=local lab results when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min/1.73m^2||Standard Deviation|Mean
1215918|NCT00765245|Secondary|Number of Patients With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death. Toxicities present at baseline and continuing without change in grade are excluded when considering worst‐grade toxicity.|30 days after completing treatment, for up to 13 months|Total number of patients reported with any toxicity|||participants|||Number
1215919|NCT00765245|Secondary|Disease-free Survival at 2 Years|Disease-free survival is the estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method where death is an event, with censoring for non‐expired patients at last known date alive.|From on-treatment date to disease recurrence, up to 2 years||||years||95% Confidence Interval|Median
1215920|NCT00765245|Primary|Disease-free Survival at 1 Year|Disease-free survival is the time from on-treatment to first relapse or death (whichever comes first). Those who are alive and without relapse are censored at the last date known alive.|From on-treatment date to disease recurrence, up to 1 year||||years||95% Confidence Interval|Mean
1215921|NCT00765232|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery||||mg||Standard Deviation|Mean
1215922|NCT00765232|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery||||units on a scale||Standard Deviation|Mean
1215923|NCT00765206|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days||||pH scale||Full Range|Median
1215924|NCT00765193|Secondary|Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.||one year|||||||
1215925|NCT00765193|Primary|Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.||one year|From a population of patients with various skin conditions, participants were considered for inclusion only if aged 18 years or more, and if suffering from focused skin complaints. Patients with diffuse skin complaints were excluded.|||participants|||Number
1215926|NCT00765128|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery||||mg||Standard Deviation|Mean
1215927|NCT00765128|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery||||units on a scale||Standard Deviation|Mean
1215928|NCT00765102|Secondary|Kaplan Meier Estimates for Overall Survival|Overall survival is the time from initiation of therapy to death from any cause.|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
1215929|NCT00765102|Secondary|Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator|"Progression-free survival is the time from initiation of therapy to progressive disease, removal from study for any reason, death from any cause, or the last follow-up visit, whichever occurs first.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
1215930|NCT00765102|Secondary|Kaplan Meier Estimate for Duration of Response Assessed by the Investigator|"Duration of response is defined as the time from first response to progressive disease as assessed by the investigator.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
1215931|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Response Assessed by the Investigator|"The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response).~Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.~Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.~Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.~Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
1216094|NCT00764790|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1215932|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Progression Assessed by the Investigator|"Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. Analysis was not performed due to early termination of the study.||||||
1215933|NCT00765102|Secondary|Total Volume of Distribution (Vz)|Total volume of distribution of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||L||Geometric Coefficient of Variation|Geometric Mean
1215934|NCT00765102|Secondary|Total Clearance (CL)|Total clearance of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1215935|NCT00765102|Secondary|Terminal Half-life (t1/2)|Terminal half-life of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||hr||Geometric Coefficient of Variation|Geometric Mean
1215936|NCT00765102|Secondary|Time to Maximum Observed Concentration (Tmax)|Time to maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||hr||Full Range|Median
1215937|NCT00765102|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1215938|NCT00765102|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0–∞)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples.|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1215939|NCT00765102|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.|up to 9 months|Safety population of participants who took at least one dose of drug.|||participants|||Number
1215940|NCT00765102|Primary|Count of Participant Best Overall Response As Assessed by the Investigator|"Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.~Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.~Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.~Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other.~Stable Disease: Less than MR, but not PD~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia."|up to 8 months|Intent-to-Treat (ITT) population of patients defined as all patients who receive at least one dose of romidepsin and bortezomib. However efficacy data was not analyzed due to the early termination of the study.||||||
1215941|NCT00765076|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1215942|NCT00765076|Secondary|Number of Subjects Reporting Any AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1215943|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1215944|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1215945|NCT00765076|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.|||Days||Full Range|Median
1215946|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1215947|NCT00765076|Secondary|Duration of Solicited Local AEs|Duration was defined as the number of days with any grade of local symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.|||Days||Full Range|Median
1215948|NCT00765076|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1215949|NCT00765076|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
1215950|NCT00765076|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||fold increase||95% Confidence Interval|Geometric Mean
1215951|NCT00765076|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
1215952|NCT00765076|Secondary|The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
1215953|NCT00765076|Secondary|Haemagglutinin Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.|At Day 0, 21, 42 and 180|The analysis of immunogenicity was performed on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1215954|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|The analysis was based on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
1215955|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
1215956|NCT00765076|Primary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)|Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. Analysis was only performed for New generation influenza vaccine GSK2186877A Group and Fluarix elderly Group.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
1215994|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215957|NCT00765063|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1215958|NCT00765063|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant’s pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Units on a scale||Standard Deviation|Mean
1215959|NCT00765063|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Participants|||Number
1215960|NCT00765063|Secondary|Time to First Amputation||Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Months||95% Confidence Interval|Median
1215961|NCT00765063|Secondary|Time to Intact Skin Healing|Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Months||95% Confidence Interval|Median
1215962|NCT00765063|Secondary|Number of Participants Who Underwent Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Participants|||Number
1215963|NCT00765063|Secondary|Number of Participants With Improved Ulcer Healing|Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Participants|||Number
1215964|NCT00765063|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.|Baseline through Week 24 (EOT) or ET|Intent to treat (ITT) population included all participants who were enrolled into the study.|||Participants|||Number
1215965|NCT00765063|Primary|Number of Trivial Hemorrhages|Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1215966|NCT00765063|Primary|Number of Clinically Relevant Minor Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1215967|NCT00765063|Primary|Number of Minor Hemorrhages|Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1215968|NCT00765063|Primary|Number of Major Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1215969|NCT00765063|Primary|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1215970|NCT00765037|Primary|Survivorship of the Encore Reverse Shoulder Prosthesis|Number of subjects who completed all study visits through the 1 year visit.|1 year||||participants|||Number
1215971|NCT00764946|Primary|Number of Participants Who Discontinued Due to an Adverse Event|Numbers of participants who discontinued due to an adverse event were summarized by race.|Week 48||||Participants|||Number
1215973|NCT00764946|Secondary|Number of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.|||participants|||Number
1215974|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count|Mean changes from baseline in CD4 cell counts were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.~Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."|||cells/mm^3||95% Confidence Interval|Mean
1215975|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in HIV RNA|Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.~Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."|||log10 copies/mL||95% Confidence Interval|Mean
1215976|NCT00764946|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values.|||Participants|||Number
1215977|NCT00764946|Primary|Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.|Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.~The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values."|||Participants|||Number
1215978|NCT00764881|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215979|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215980|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215981|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215982|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215983|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215984|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215985|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215986|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215987|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215988|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1215989|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1215990|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1215995|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215996|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1215997|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215998|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1215999|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1216000|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216001|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216002|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216003|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216004|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216005|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216006|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1216007|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1216008|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1216009|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216010|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216011|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216012|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216014|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216015|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1216016|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1216017|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216018|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216019|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216020|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216021|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216022|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216023|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216024|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216025|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1216026|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1216027|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 2|Reference Period 2 is defined as Day 91 to 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216028|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 1|Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1216029|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216030|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216031|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Baseline|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216032|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216033|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216034|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216035|NCT00764881|Secondary|Vaginal Effects Evaluated by Vaginal pH at Cycle 6|Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Proportion of participants|||Number
1216036|NCT00764881|Secondary|Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1216037|NCT00764881|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1216038|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Vitality|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216039|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Cycle 6|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216040|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Baseline|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216041|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – General Health|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216042|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Cycle 6|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216043|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Baseline|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216044|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Self-control|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216045|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Cycle 6|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1232656|NCT00640224|Secondary|DHEAS at Baseline and 6 Months|DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.|Baseline and 6 months||||ug/dL||Standard Error|Mean
1216046|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Baseline|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216047|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Positive Well-being|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216048|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Cycle 6|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216049|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Baseline|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216050|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Depressed Mood|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216051|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Cycle 6|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216052|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Baseline|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216053|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Anxiety|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216054|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Cycle 6|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216055|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Baseline|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216056|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score|Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216057|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6|The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216058|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline|The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Baseline|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1216059|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216060|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6|Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216061|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline|Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216062|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score|Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216063|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216064|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216065|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Total Score|The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216066|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Cycle 6|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216067|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Baseline|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
1216068|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)|Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216069|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216070|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216071|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)|Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216072|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6|Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216073|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline|Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216074|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)|Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216075|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6|Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216077|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)|Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1216078|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1216079|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1216080|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)|Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1216081|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6|Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1216082|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline|Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
1216083|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)|Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1216084|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1216085|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
1216086|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Per Protocol Set (PPS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|Per Protocol Set (PPS) includes those participants of the FAS without major protocol deviations affecting the primary variables|||scores on a scale||Standard Deviation|Mean
1216087|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Full Analysis Set (FAS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1216088|NCT00764868|Secondary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and Up to 52 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1216089|NCT00764868|Secondary|Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 52 weeks|FAS|||Percent of participants|||Number
1216090|NCT00764868|Primary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 52 weeks|Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure.|||Units on a scale||Standard Deviation|Mean
1216091|NCT00764790|Secondary|Number of Subjects Reporting Rare Serious Events|Rare serious events have an occurrence rate of 1/300 (0.3%).|During the entire study (Day 0 until Month 6)||||Participants|||Count of Participants
1216092|NCT00764790|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.~NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders"|During the entire study (Day 0 until Month 6)||||Participants|||Count of Participants
1216093|NCT00764790|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During a 28-day follow-up period after vaccination||||Participants|||Count of Participants
1216096|NCT00764790|Secondary|Seroconversion Factor|"Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity|||fold increase||95% Confidence Interval|Mean
1216097|NCT00764790|Secondary|Number of Seroprotected Subjects|"A seroprotected subject is a subject with a serum anti-HA titer~≥ 1:40~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity|||Participants|||Count of Participants
1216098|NCT00764790|Primary|Number of Subjects Who Seroconverted|"Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity|||Participants|||Count of Participants
1216099|NCT00764790|Primary|Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains|"GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||titre||95% Confidence Interval|Geometric Mean
1216100|NCT00764699|Primary|The Primary Outcome Variable for the Monitoring Study (Baseline, Six Months and Disease Exacerbation) Will be Longitudinal Growth as Measured by Height Velocity||Six months and 1 year|The PI left the institution suddenly and participant records stayed with the institution, so no analysis was able to be performed.||||||
1216101|NCT00764673|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|All subjects in the study were evaluated for adverse events.|||Events|||Number
1216102|NCT00764673|Primary|Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.|Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.|2-year|The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.|||participants|||Number
1216103|NCT00764673|Secondary|Oxford Knee Score|Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.|2-year|The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit.|||Units on a scale||Standard Deviation|Mean
1216104|NCT00764673|Primary|Knee Society Function Score|The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.|2-year|The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.|||Average Knee Function Score||Standard Deviation|Mean
1216105|NCT00764673|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|The number of subjects who completed their 2 year visit.|||Average Knee Rating Score||Standard Deviation|Mean
1216106|NCT00764660|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 12 weeks|The APT population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1216107|NCT00764660|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 16 weeks|The All-Participants-Treated (APT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1216108|NCT00764660|Secondary|Change From Baseline in Mood VAS Score|Participants were asked to answer the question: “Over the past week, how did you feel?” The 100 mm line of the VAS was anchored on the left by “Extremely bad” and on the right by “Extremely good”. Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1216109|NCT00764660|Secondary|Change From Baseline in Motivation VAS Score|Participants were asked to answer the question: “Over the past week, how motivated were you to stay alcohol abstinent?” The 100 mm line of the VAS was anchored on the left by “No motivation at all” and on the right by “Extremely motivated”. Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1216123|NCT00764517|Secondary|Progression-free Survival|"Time from treatment start until disease progression or death.~Estimated using the Kaplan-Meier method. A logrank test will be used to compare progression-free survival between Group I and Group II. A p-value less that 0.05 will be considered statistically significant."|Up to 5 years||||Months||95% Confidence Interval|Median
1216110|NCT00764660|Secondary|Change From Baseline in Craving Visual Analog Scale (VAS) Score|Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: “Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink?” The 100 mm line of the VAS was anchored on the left by “No desire at all” and on the right by “Extreme desire”. Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1216111|NCT00764660|Secondary|Global Functioning: CGI - Therapeutic Effect|The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||Standard Deviation|Mean
1216112|NCT00764660|Secondary|Global Functioning: Clinical Global Impression (CGI) - Severity of Illness|The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||Standard Deviation|Mean
1216113|NCT00764660|Secondary|Percentage of Participants With Complete Abstinence|Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Participants|||Number
1216114|NCT00764660|Secondary|Percentage of Abstinent Days|Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1216115|NCT00764660|Secondary|Time to First Relapse Into Drinking|Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of <1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Days||Standard Deviation|Mean
1216116|NCT00764660|Secondary|Number of Lapses Into Any Drinking|An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Lapses||Standard Deviation|Mean
1216117|NCT00764660|Secondary|Number of Relapses Into Heavy Drinking|An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Relapses||Standard Deviation|Mean
1216118|NCT00764660|Secondary|Number of Drinks Per Drinking Day|The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with ‘day’ being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Drinks||95% Confidence Interval|Least Squares Mean
1216119|NCT00764660|Primary|Percentage of Heavy Drinking Days|"Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use.~A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol).~Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval."|12 weeks|The modified Intent-to-Treat (mITT) population consisted of all participants from the All-Participants-Treated (APT) population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1216120|NCT00764517|Secondary|Scientific Correlates|"Perform scientific correlates to determine if SCR treatment a) is associated with global and gene specific changes in transcription of mRNAs and MiRNAs b) is acting as an inhibitor of DNA methylation c) is activating or silencing specific genes or miRNAs.~Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis."|Baseline|Data not collected and the outcome will never be analyzed.||||||
1216121|NCT00764517|Secondary|Contribution (if Any) of DNA Methylation/Histone Deacetylation|"Determine the contribution (if any) of DNA methylation/histone deacetylation to disease progression and/or response to SCR combination chemotherapy.~Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis."|Up to 2 years|Data not collected and the outcome will never be analyzed.||||||
1216122|NCT00764517|Secondary|Event-free Survival|"Time from treatment start until disease progression, death, or discontinuation of treatment for adverse event (toxicity)~Estimated using the Kaplan-Meier method. A logrank test will be used to compare progression-free survival between Group I and Group II. A p-value less that 0.05 will be considered statistically significant."|Up to 5 years||||Months||95% Confidence Interval|Median
1232657|NCT00640224|Secondary|SHBG at Baseline and 6 Months|SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.|Baseline and 6 months||||nmol/L||Standard Error|Mean
1216124|NCT00764517|Primary|Tolerability of Treatment|Tolerability is determined to be the percentage of patients who completed the full duration of treatment (all 6 cycles) regardless of adverse event status. % tolerability shows the rate of patients that tolerated the treatment for the full duration.|6 months||||percentage of participants||95% Confidence Interval|Number
1216125|NCT00764517|Primary|Toxicities as Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Toxicity is determined percentage of patients that experienced an adverse event (AE) grade 3 or higher during the time frame, assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade refers to the severity of the AE increasing from Grade 1 to 5. Generally, Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; Grade 5 = Death related to AE.|6 months||||percentage of participants||95% Confidence Interval|Number
1216126|NCT00764517|Primary|Objective Response Rate|ORR defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR). Assessed per the revised Cheson criteria. Response definitions per revised International Working Group Response Criteria. 95% confidence interval will be provided. Definitions: Complete response (CR) = disappearance of all evidence of disease; Partial response (PR) = regression of measurable disease and no new sites.|2 years||||percentage of participants||95% Confidence Interval|Number
1216127|NCT00764504|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.|||adverse events|||Number
1216128|NCT00764504|Primary|Radiographic Failures|Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis.|Post-operative, 3-month, 6-month, 1-year, 2-year|Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.|||participants|||Number
1216129|NCT00764504|Primary|"Neer's Limited Goals"|To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
1216130|NCT00764504|Primary|Have Surgery Again?|Subject satisfaction: subject's willingness to have surgery performed again if necessary.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
1216131|NCT00764504|Primary|Subject Satisfaction With Surgery|Each subject had a chance to rate their satisfaction with surgery at each study interval.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
1216132|NCT00764504|Primary|Average Range of Motion|Physician's assessment of a subject's range of motion in degrees.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||Angle of Degrees of Shoulder Motion||Standard Deviation|Mean
1216133|NCT00764504|Primary|American Shoulder and Elbow Surgeons Shoulder Score|"The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:~[(10 – Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score]"|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||Units on a scale||Standard Deviation|Mean
1216134|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score sums the scores from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216135|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score sums the score from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216136|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216137|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216138|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score sums the scores from all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216139|NCT00764478|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale sums the scores from all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216140|NCT00764478|Secondary|Change From Baseline in PANSS Positive Subscale Score|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216141|NCT00764478|Secondary|Change From Baseline in PANSS Negative Subscale Score|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216142|NCT00764478|Secondary|Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score sums the scores from all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216143|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score|The CGI-BP-I depression is a score on a 7-point scale for assessing the change from preceding phase of depression symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I depression score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1216144|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score|The CGI-BP-I mania is a score on a 7-point scale for assessing the change from preceding phase of mania symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I mania score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1216145|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score|The CGI-BP-I overall is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I overall score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1216146|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Depression Score|The CGI-BP-S depression is a score that assesses the severity of the depression component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1216147|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Mania Score|The CGI-BP-S mania is a score that assesses the severity of the mania component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216148|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216149|NCT00764478|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS measures depression and consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score sums the scores from the 10 items, ranging from 0 to 60, with a higher numeric rating implying a greater degree of symptom severity. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7 and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1216150|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a generalized linear mixed model (GLMM). Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 2, Day 4, Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1216151|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement.|||Percentage of participants|||Number
1216152|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1216153|NCT00764478|Secondary|Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7 and Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216154|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Percentage of participants|||Number
1216176|NCT00763971|Secondary|Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1216155|NCT00764478|Secondary|Change From Baseline in Clinical Global Impression – Bipolar Mania – Severity of Illness (CGI-BP-S) Overall Score at Day 21|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216156|NCT00764478|Primary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1216157|NCT00764465|Primary|AUC: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng•h/mL||90% Confidence Interval|Mean
1216158|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng/mL||90% Confidence Interval|Mean
1216159|NCT00764465|Secondary|Number of Participants Who Experienced an Adverse Event|"Safety/tolerability data collected included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:~MVC 300mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with MVC 300mg BID~FPV 700mg/RTV 100 mg BID combined with MVC 300mg BID~FPV 1400mg/RTV 100mg QD combined with MVC 300mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004"|Day 0 through Day 49||||participants|||Number
1216160|NCT00764465|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens||||ng•h/mL||90% Confidence Interval|Mean
1216161|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens||||ng/mL||90% Confidence Interval|Mean
1216162|NCT00764361|Secondary|Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)||baseline, week 4, week 10, week 20|||||||
1216163|NCT00764361|Primary|Number of Participants Without Adverse Events|Participants were monitored for 20 weeks during the study.|every 2 weeks||||participants|||Number
1216164|NCT00764322|Secondary|Patient Understanding of Pharmacogenomics|To examine patients' beliefs about how hypothetical genotype information would affect their perceived recurrence risk and benefits of tamoxifen therapy, participants were given experimentally manipulated 6 vignettes to describe hypothetical tamoxifen treatment (no or yes) and hypothetical genotype (EM, IM or PM). For each vignette, participants gave their perceived recurrence risk (RR; 0-100%)|baseline|Of 377 patients who were eligible to complete the survey, 320 patients completed the survey and 57 returned incomplete surveys|||percent chance of recurrence||Full Range|Mean
1216195|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216165|NCT00764322|Secondary|Change in Plasma Endoxifen Levels After an Increase in Tamoxifen Citrate Dose From 20 mg to 40 mg Daily in Patients With Poor-metabolizing Genotypes|The intrapatient change in median endoxifen levels were calculated between baseline and 4 months after the increase in dose of Tamoxifen from 20mg/day to 40 mg/day|Baseline and 4 months after dose increase|Analysis limited to only those subjects with the Poor Metabolizing (PM) genotype who were evaluable at baseline|||ng/mL||Inter-Quartile Range|Median
1216166|NCT00764322|Secondary|CYP2D6 Allele Frequencies and Endoxifen Levels Among African-American Women Taking Tamoxifen Citrate|Mean endoxifen levels by CYP2D6 genotype among African Americans. Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline.The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.|baseline|Only participants who self-identified as African American were included in this analysis|||ng/ml||Full Range|Mean
1216167|NCT00764322|Secondary|Change in Median Endoxifen Concentrations to Determine Feasibility of Obtaining Pharmacogenomic Information From Patients in the Clinical Setting and Using it to Guide Changes in Therapy|If the key active tamoxifen metabolite, endoxifen, could be significantly increased by genotype-guided tamoxifen dosing in patients with intermediate CYP2D6 metabolism (by increasing tamoxifen dosing based on CYP2D6 genotype), then the study would be deemed feasible and the accrual expanded.|Baseline and 4 months after dose increase|This was based on the initial 119 subjects enrolled (based on initial sample size of 100) and of those, the 89 that completed 4 months of tamoxifen therapy|||ng/mL||Inter-Quartile Range|Median
1216168|NCT00764322|Secondary|Number of Participants With Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), Stroke, and/or Endometrial Cancer|"The doubling of tamoxifen dose is defined as unacceptable (i.e., not tolerable) if the prevalence of Pulmonary embolism (PE), Deep vein thrombosis (DVT), stroke, or endometrial cancer, either individually or in any combination, is greater than 2%."|Approximately ten months from registration to last follow-up|Incidence of unacceptable adverse events among all patients who completed study|||Participants|||Count of Participants
1216169|NCT00764322|Primary|Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes|Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.|4 months|Baseline measurements are reported on all 353 subjects, while the 4 month levels are reported only for patients who completed 4 months of treatment|||ng/mL||Standard Deviation|Mean
1216170|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Blood Chemistry Per (NCI-CTCAE) Version 3.0 Grade (GR)|GR0=normal,1=mild,2=moderate,3=severe,4=life-threatening. ALP(U/L) GR0:40-135,GR1:>135-337; ALT(U/L) GR0:0-47,GR1:>47-117; AST(U/L) GR0:0-37,GR1:>37-93; High(↑) Calcium(mg/dL) GR0:8.4-10.2,GR1:>10.2-11.5; Low(↓) Calcium(mg/dL) GR0:8.4-10.2,GR1:<8.4-8.0,GR2:7.0-<8.0; CK(U/L) GR0:24-195,GR1:>195-488, GR2:>488-975; Creatinine(mg/dL) GR0:0.6-1.4,GR1:>1.4-2.1,GR2:>2.1-4.2; ↑Potassium(mEq/L) GR0:3.6-5.2,GR1:>5.2-5.5,GR2:>5.5-6.0; ↑Sodium(mEq/L) GR0:134-146; ↓Sodium(mEq/L) GR0:134-146,GR1:<134-130; Inorganic Phosphorus(mg/dL) GR0:2.4-4.9,GR2:≥2.0-<2.5; Total Bilirubin(mg/dL) GR0:0-1.1,GR1:>1.1-2.75.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||participants|||Number
1216171|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Hematology|Toxicity was graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. (Grade (GR)0=normal, GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening). Granulocyte count (x 10^9 /L), GR1: ≥1.0 - <1.5, GR2: ≥0.5 - <1.0; Hemoglobin (g/dL), GR0: 13-17, GR1: <13 - 10.0 , GR2: 8.0 - <10.0, GR3: 6.5 - <8.0; Platelet count (x 10^9 /L) GR0: 150-400, GR2: ≥50.0 - <75.0; Leukocyte count (x 10^9 /L ), GR0: 3.5-11.1, GR2: 2.0 - <3.0.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||participants|||Number
1216172|NCT00764309|Primary|Reasons for Discontinuation of Study Treatment|"Participants who discontinued the study due to any AEs were recorded.~Significant drug-related discontinuations were those SAEs recorded on the SAE case report forms with relationship to study drug of related or missing and action taken regarding study drug of discontinued or missing."|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||Participants|||Number
1216173|NCT00764309|Primary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||Participants|||Number
1216174|NCT00763971|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.|Up to 7 weeks|Safety Population|||participants|||Number
1216175|NCT00763971|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 7 weeks|Safety Population defined as all subjects who took at least 1 dose of investigational product.|||Scores on a scale||Standard Deviation|Mean
1216219|NCT00763867|Other Pre-specified|Cystatin C||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1216177|NCT00763971|Secondary|Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline and up to 7 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
1216178|NCT00763971|Secondary|Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Deviation|Mean
1216179|NCT00763971|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1216180|NCT00763971|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 7 weeks|FAS|||percentage of participants|||Number
1216181|NCT00763971|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and up to 7 weeks|Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product.|||Scores on a scale||Standard Error|Least Squares Mean
1216182|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.|Number of participants with positive opiate urine sample at the 24 week follow-up.|24 weeks|All subjects were included in the analysis population as intent to treat.|||participants|||Number
1216183|NCT00763958|Secondary|Number of Participants Who Enroll in the Study.|To determine the number of participants who enroll in the study during the time of recruitment.|up to 24 months||||participants|||Number
1216184|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.|Number of participants with positive opiate urine samples at 12 weeks of treatment.|12 weeks|All subjects were included in the analysis population as intent to treat.|||participants|||Number
1216185|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216186|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216187|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216188|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216189|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216190|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216191|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216192|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216193|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216194|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216196|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216197|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216198|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216199|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216200|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216201|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216202|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216203|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216204|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1216205|NCT00763919|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216206|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216207|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1216208|NCT00763867|Other Pre-specified|Furosemide-Equivalent Dose||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
1216209|NCT00763867|Other Pre-specified|Galectin 3||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL||Standard Deviation|Mean
1216210|NCT00763867|Other Pre-specified|Cyclic Guanosine Monophosphate (cGMP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pmol/mL||Standard Deviation|Mean
1216211|NCT00763867|Other Pre-specified|Collagen Type I (CITP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1216212|NCT00763867|Other Pre-specified|High Sensitivity C-Reactive Protein||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1216213|NCT00763867|Other Pre-specified|Endothelin-1||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1216214|NCT00763867|Other Pre-specified|Procollagen III N-terminal Peptide||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1216215|NCT00763867|Other Pre-specified|High Sensitivity Troponin I||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1216216|NCT00763867|Other Pre-specified|Aldosterone||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1216217|NCT00763867|Other Pre-specified|N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1216218|NCT00763867|Other Pre-specified|Uric Acid||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1216222|NCT00763867|Other Pre-specified|ECHO Pulmonary Artery Systolic Pressure|A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mmHg||Standard Deviation|Mean
1216223|NCT00763867|Other Pre-specified|MRI Aortic Distensibility|An increase in Aortic Distensibility is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||cm^2*dyne-1||Standard Deviation|Mean
1216224|NCT00763867|Other Pre-specified|MRI Aortic Thickness|A decrease in Aortic Thickness is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mm||Standard Deviation|Mean
1216225|NCT00763867|Other Pre-specified|MRI Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Woods units||Standard Deviation|Mean
1216226|NCT00763867|Other Pre-specified|MRI Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Farads-1||Standard Deviation|Mean
1216227|NCT00763867|Other Pre-specified|ECHO Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Woods units||Standard Deviation|Mean
1216228|NCT00763867|Other Pre-specified|ECHO Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Farads-1||Standard Deviation|Mean
1216229|NCT00763867|Other Pre-specified|Lateral Filling Pressure|A decrease in lateral filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
1216230|NCT00763867|Other Pre-specified|Medial Filling Pressure|A decrease in medial filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
1216231|NCT00763867|Other Pre-specified|Lateral Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
1216232|NCT00763867|Other Pre-specified|Medial Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
1216233|NCT00763867|Other Pre-specified|Lateral Diastolic Elastance|A decrease in Lateral Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||(m/sec)/cc||Standard Deviation|Mean
1216234|NCT00763867|Other Pre-specified|Medial Diastolic Elastance|A decrease in Medial Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||(m/sec)/cc||Standard Deviation|Mean
1216235|NCT00763867|Other Pre-specified|Echocardiogram Left Ventricular Mass|A decrease in Left Ventricular Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm||Standard Deviation|Mean
1216236|NCT00763867|Other Pre-specified|MRI Left Ventricular Ejection Fraction (LVEF)|An increase in LVEF is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||percentage of volume||Standard Deviation|Mean
1216237|NCT00763867|Other Pre-specified|MRI Left Ventricular End Systolic Volume Index|An increase in Left Ventricular End Systolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/m^2||Standard Deviation|Mean
1216238|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume Index|An increase in Left Ventricular End Diastolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/m^2||Standard Deviation|Mean
1216239|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume|An increase in Left Ventricular End Diastolic Volume is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1216240|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass Index|A decrease in Left Ventricular Mass Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm/m^2||Standard Deviation|Mean
1216241|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass|A decrease in LV Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm||Standard Deviation|Mean
1216242|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire|The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1216453|NCT00762463|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 6|C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline <0 indicated improvement.|Baseline, 6 Weeks|FAS|||mg/L||Standard Error|Least Squares Mean
1216243|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHFQ)|"The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.~Total score: 0 – 105 Physical subscore: 0 – 40 Emotional subscore: 0 – 25"|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1216244|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
1216245|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
1216246|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||minutes||Standard Deviation|Mean
1216247|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||minutes||Standard Deviation|Mean
1216248|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 minute walk distance|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||meters||Standard Deviation|Mean
1216249|NCT00763867|Secondary|Composite Score Reflective of Clinical Status|"Participants ranked sequentially with ranking stratified in one of three tiers based on:~Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier.~Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier.~Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier)~The use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better)"|Measured at Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1216250|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 Minute Walk Distance|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||meters||Standard Deviation|Mean
1216251|NCT00763867|Secondary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
1216252|NCT00763867|Primary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
1216253|NCT00763815|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1216254|NCT00763815|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1216255|NCT00763815|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1232658|NCT00640224|Secondary|Free Testosterone at Baseline and 6 Months|Free testosterone was measured by equilibrium dialysis.|Baseline and 6 months||||pg/mL||Standard Error|Mean
1216256|NCT00763815|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
1216257|NCT00763815|Secondary|Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1216258|NCT00763815|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1216259|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPI assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
1216260|NCT00763815|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1216261|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1216262|NCT00763815|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1216263|NCT00763750|Primary|Number of Patients Assessed for Toxicity According to CTC Version 3.0||Throughout the entire study until patient is removed from study an average of 6 weeks||||participants|||Number
1216264|NCT00763698|Primary|Left Ventricular Bipolar Pacing Capture Threshold (Volts)|The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.|3 months|This effectiveness endpoint was carried out on the first 16 patients who had a LV lead bipolar pacing capture threshold measurement at 3 months at 0.5 ms pulse width. This patient cohort is referred to as the “Primary Pacing Capture Threshold Patient Cohort”.|||volts||Standard Deviation|Mean
1216265|NCT00763698|Primary|Percentage of Successful Left Ventricular Lead Implants|Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.|3 months|All patients with an implant or attempted implant were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1216266|NCT00763698|Primary|Freedom From Left Ventricular Lead-related Complications|A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.|3 months|Analysis was conducted on the 81 patients with a successful left ventricular lead implant.|||percent of participants||95% Confidence Interval|Number
1216267|NCT00763490|Secondary|Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)|"The percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated.~Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea)."|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
1216268|NCT00763490|Secondary|Cumulative Incidence of Neutrophil and Platelet Engraftment|The failure to achieve a neutrophil count > 500/uL or a platelet count >30.0 x 10e9 /L within 35 days of the stem cell infusion will be defined as primary engraftment failure.|Day 35||||percentage of participants||95% Confidence Interval|Number
1216269|NCT00763490|Secondary|Percentage of Patients Alive at the End of the Trial|Event Free Survival (EFS) was determined. Patients were followed up to 5 years (median time of 2.35 years).|5 Years||||percentage of patients||95% Confidence Interval|Number
1216270|NCT00763490|Primary|Percentage of Participants Alive at 1 Year After Transplant|One-year survival rate after transplant|1 year||||percentage of participants||95% Confidence Interval|Number
1216271|NCT00763451|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks|"Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||participants|||Number
1216272|NCT00763451|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
1216273|NCT00763451|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|"mITT population. The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
1216274|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
1216275|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
1216305|NCT00763256|Primary|P. Gingivalis|Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.|12 months||||Pg/ng DNA||Inter-Quartile Range|Median
1216400|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216276|NCT00763451|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||kilogram||Standard Error|Least Squares Mean
1216277|NCT00763451|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.The Placebo (Two-step Titration)andPlacebo (One-step Titration)Arms/Groups were combined as pre-specified in the study protocol"|||mmol/L||Standard Error|Least Squares Mean
1216278|NCT00763451|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.~The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1216279|NCT00763412|Secondary|C-Peptide||2 year||||pg/ml||Full Range|Mean
1216280|NCT00763412|Secondary|FEV 1|% of lung function|2 year/end of study||||% lung function||Full Range|Mean
1216281|NCT00763412|Secondary|Tanner Stage|Puberty scale measuring 1-5, 1 being least development, 5 being most development.|2 year/end of study||||units on a scale||Full Range|Mean
1216282|NCT00763412|Secondary|Wt Z Score||2 year/end of study||||Z score||Full Range|Mean
1216283|NCT00763412|Secondary|Inflammatory Markers||2 year/end of study||||pg/ml||Full Range|Mean
1216284|NCT00763412|Secondary|Glucose Tolerance|We completed the OGTT at the 2 year/end of study visit.|2-year||||mg/dl||Full Range|Mean
1216285|NCT00763412|Primary|CRP||2 year/end of study||||mg/L||Full Range|Mean
1216286|NCT00763412|Primary|Body Composition|Reporting % of Fat and Lean body mass|2 year/end of study||||% body mass||Full Range|Mean
1216287|NCT00763412|Primary|BMI||2 year/end of study||||Kg/m^2||Full Range|Mean
1216288|NCT00763386|Secondary|Return to Function (RtF) Via Knee Society Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.~Grading for the Knee Society Score is based on a scale from 0-100 and results are established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|6 Weeks to 2 Years Post-op, based on on the intervals listed||||units on a scale||Standard Deviation|Mean
1216289|NCT00763386|Primary|Postoperative Range of Motion (ROM)|Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.|6 Weeks to 2 Years Post-op, based on on the intervals listed|Analysis was determined by calculating the measurements of the enrolled cases who completed the stated visit interval.|||degrees||Standard Deviation|Mean
1216290|NCT00763360|Secondary|Corneal Clarity|Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.|2 weeks|Data from subjects for whom this evaluation was not performed is not included in this analysis.|||units on a scale|||Number
1216291|NCT00763360|Secondary|Change in Corneal Thickness|Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.|1 month|Subjects that did not have both baseline and 1 month values were not included in this analysis.|||millimeters||Standard Deviation|Median
1216292|NCT00763360|Primary|Investigator Reported Space Maintenance|"Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: Full Chamber Maintained, Working Space Maintained, Shallow, Flat. Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion."|During surgical procedure||||participants|||Number
1216293|NCT00763360|Primary|Endothelial Cell Count Change From Baseline|Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.|one month|Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis.|||Percent change from baseline||Standard Deviation|Mean
1216306|NCT00763256|Primary|Gingivitis Score (GI)|"Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|12 months||||Units on a scale||Standard Deviation|Mean
1216450|NCT00762463|Secondary|Percentage of Days With Concomitant Administration of Paracetamol|Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.|Week 6|FAS|||percentage of days||Standard Deviation|Mean
1216294|NCT00763321|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant’s sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.|||scores on a scale||Standard Error|Least Squares Mean
1216295|NCT00763321|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).|||scores on a scale||Standard Error|Least Squares Mean
1216296|NCT00763282|Secondary|Mean Number of Skin-related Admissions|Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.|Discharge to end of study (6 months)|Mean number of skin-related post-discharge admissions (ICD9 code =707.xx)|||admissions/participant||Standard Deviation|Mean
1216297|NCT00763282|Primary|Skin Status|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|Admission (Baseline), 3 months, 6 months||||participants|||Number
1216298|NCT00763282|Primary|Any Skin Worsening|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|6 months||||participants|||Number
1216299|NCT00763282|Primary|Skin Behavior Change|"Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms.~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months||||% Change||Standard Deviation|Mean
1216300|NCT00763282|Primary|Percent of Possible Self-Reported Skin Care Behaviors|"Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline).~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months||||% of Possible Self-Reported Behaviors||Standard Deviation|Mean
1216301|NCT00763269|Secondary|Air Blast Hypersensitivity (8 Week)|"Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth."|8 weeks||||units on a scale||Standard Deviation|Mean
1216302|NCT00763269|Secondary|Air Blast Hypersensitivity (4 Week)|Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:“0”No subject response to stimulus“1”responds but will continue“2”responds and moves or requests discontinuation“3”Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.|4 weeks||||units on a scale||Standard Deviation|Mean
1216303|NCT00763269|Primary|Hypersensitivity Tactile (Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|8 weeks||||Units on a scale||Standard Deviation|Mean
1216304|NCT00763269|Primary|Hypersensitivity Tactile(Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|4 weeks||||units on a scale||Standard Deviation|Mean
1216352|NCT00762788|Primary|Incidence of Adverse Events|Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.|||percentage of participants||95% Confidence Interval|Number
1216307|NCT00763256|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||nmol/L||Standard Deviation|Mean
1216308|NCT00763256|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||mg/L||Standard Deviation|Mean
1216309|NCT00763256|Primary|HbA1c Levels in Blood|Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||Percentage||Standard Deviation|Mean
1216310|NCT00763243|Primary|Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)|"The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory."|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
1216311|NCT00763243|Primary|Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)|This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory.|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
1216312|NCT00763243|Primary|Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)|This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
1216313|NCT00763139|Secondary|ESR|sed rate|baseline and after 8 weeks on either placebo or pioglitazone||||mm/hr||Standard Deviation|Mean
1216314|NCT00763139|Secondary|C-reactive Protein (CRP)||Measured after 8 weeks of treatment||||mg/dl||Standard Deviation|Mean
1216315|NCT00763139|Primary|Homeostasis Model Assessment (HOMA) for Insulin Sensitivity|Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose * Insulin/22/5|Measured after 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
1216316|NCT00763139|Primary|Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)|A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH|Measured after 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
1216317|NCT00763061|Secondary|Mean IOP Change at 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 4 PM||||mmHg||Standard Deviation|Mean
1216318|NCT00763061|Primary|Week 12 - Mean IOP At 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At the 4 PM time point for the patient's worse eye.||||mmHg||Standard Deviation|Mean
1216319|NCT00763061|Secondary|Mean IOP Change From Baseline at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 9 AM||||mmHg||Standard Deviation|Mean
1216320|NCT00763061|Primary|Mean Intraocular Pressure (IOP) at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At Week 12 - At the 9 AM time point for the patient's worse eye.||||millimeters mercury (mmHg)||Standard Deviation|Mean
1216321|NCT00763048|Primary|Metabolite Associated With Inflammation (Xanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216322|NCT00763048|Primary|Metabolite Associated With Inflammation (Putrescine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216323|NCT00763048|Primary|Metabolite Associated With Inflammation (Phenylalanine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216324|NCT00763048|Primary|Metabolite Associated With Inflammation (Lysine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216325|NCT00763048|Primary|Metabolite Associated With Inflammation (Leucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216326|NCT00763048|Primary|Metabolite Associated With Inflammation (Isoleucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216327|NCT00763048|Primary|Metabolite Associated With Inflammation (Inosine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216328|NCT00763048|Primary|Metabolite Associated With Inflammation (Hypoxanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216329|NCT00763048|Primary|Metabolite Associated With Inflammation (Choline)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216330|NCT00763048|Primary|Metabolite Associated With Inflammation (Cadaverine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1216331|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing)|To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Episodes of (SBP>140), low number represent better outcome. Episodes of arrhythmias (including PVCs) and bradycardia (HR<60), low number represent better outcome. Episodes of wheezing and SPO2<94%, low number represent better outcome.|1 day||||number of episodes||Full Range|Mean
1216332|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire|To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Ease of Administration - Scale from 1(most easy among all MRI stress tests) to 5(most difficult), low score represent better outcome. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Side effects - Scale from 1(fewer than any other MRI stress test) to 4(the most), low score represent better outcome.|1 day||||units on a scale||Full Range|Mean
1216333|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing)|To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Low scores represent better outcome.|1 day||||number of episodes||Full Range|Mean
1216353|NCT00762788|Primary|Incidence of Corneal Infiltrative Events|Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.|||percentage of participants||95% Confidence Interval|Number
1216354|NCT00762762|Primary|TNF-α (Tumor Necrosis Factor - Alpha)|Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.|12 months||||pg/ml||Standard Deviation|Mean
1216334|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire|To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Level of monitoring - Scale from 1(most easy among all MRI tests) to 4(most difficult), low score represent better outcome. Level of anxiety while during the procedure - Scale from 1(less than any other MRI stress test) to 4(the most), low score represent better outcome. Overall rating of the procedure - Scale from 1(very difficult) to 4(very easy), higher scores represent better outcome.|1 day||||units on a scale||Full Range|Mean
1216335|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing)|Ease of Administration of regadenoson versus intravenous dobutamine using Compare MD Questionnaire. Episodes of arrhythmias (including PVCs) and bradycardia (HR<60), low score represent better outcome. Number of Episodes of wheezing and SPO2<94%, low numbers represent better outcome.|1 day||||number of episodes||Full Range|Mean
1216336|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire|The Compare MD tool have the following scales: Ease of Administration - Scale from 1(most easy among all MRI stress tests) to 5(most difficult), low score represent better outcome. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Side effects - Scale from 1(fewer than any other MRI stress test) to 4(the most), low score represent better outcome. Level of anxiety while during the procedure - Scale from 1(less than any other MRI stress test) to 4(the most), low score represent better outcome. Overall rating of the procedure (1 very Difficult to 5 very easy), higher scores represent better outcomes.|1 day||||units on a scale||Full Range|Mean
1216337|NCT00763035|Primary|Duration of Procedures|To compare the time involved during pharmacologic stress testing using regadenoson versus intravenous dobutamine in individuals with moderate to severe chronic obstructive pulmonary disease (COPD)or asthma.|1 day||||Minutes||Full Range|Mean
1216338|NCT00763009|Secondary|To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.||6-12 months|The study was terminated due to poor enrollment||||||
1216339|NCT00763009|Primary|To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function.|To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling|6-12 months|"All patients responded. Function and Expression of the Transporter were therefore not performed.~The study was terminated due to poor enrollment"||||||
1216340|NCT00762996|Secondary|Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable|1 week||||Units on a scale||Standard Error|Least Squares Mean
1216341|NCT00762996|Primary|Distance Visual Acuity|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|1 week||||logMar||Standard Error|Least Squares Mean
1216342|NCT00762970|Primary|Axial Length (Axial Elongation)|Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||millimeter (mm)|eyes|Standard Deviation|Mean
1216343|NCT00762970|Primary|Spherical Equivalent Refraction|Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||diopter (D)|eyes|Standard Deviation|Mean
1216344|NCT00762931|Secondary|Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).|"An assessment of Forced Expiry Volume in 1second (FEV1) measurements were taken throughout the course of treatment (15,30 and 60 minutes).~Peak FEV1 measurements were recorded for each subject, and the number of minutes the subject had received treatment at the time of peak FEV1.~The threshold for improvement was set at 12% over baseline at any of the time points (15,30 and 60 minutes). Outcome measure data indicates the number of subjects above 12%."|60 minutes|Safety population. 1 subject result missing due to no stimulation performed.|||Participants|||Count of Participants
1216345|NCT00762931|Primary|Safety- Number of Participants With Adverse Events|Safety- Number of participants that reported Adverse Events|2 weeks|Safety|||Participants|||Count of Participants
1216346|NCT00762892|Secondary|Change From Baseline in Homocysteine at 6 Months||Baseline and 48 weeks||||umol/L||Standard Deviation|Mean
1216347|NCT00762892|Secondary|Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks||Baseline and 48 weeks||||pg/mL||Standard Deviation|Mean
1216348|NCT00762892|Primary|Change From Baseline in Log HIV Viral Load at 48 Weeks||Baseline and 48 weeks||||copies/mL||Standard Deviation|Mean
1216349|NCT00762892|Secondary|Change From Baseline in Lipids at 48 Weeks||Baseline and 48 weeks||||mg/dL||Standard Deviation|Mean
1216350|NCT00762892|Primary|Change From Baseline in CD4 Count at 48 Weeks||Baseline and 48 weeks||||cells/uL||Standard Deviation|Mean
1216351|NCT00762853|Primary|Triclosan Concentration in Dental Plaque|Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.|12 hours||||ppm levels of triclosan||Standard Deviation|Mean
1216355|NCT00762762|Primary|IL-6 (Interleukin - 6)|Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picagrams)|12 months||||pg/ml||Standard Deviation|Mean
1216359|NCT00762723|Primary|Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)|- Fusion Assessment|Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months|Data not analyzed because study was stopped due to slow enrollment.||||||
1216360|NCT00762645|Secondary|Number of Patients With Peripheral Anterior Synechiae (PAS)||Week 12 Visit||||Participants|||Number
1216361|NCT00762645|Primary|Mean Intraocular Pressure (IOP)||4PM at Week 12 Visit||||millimeters mercury (mm Hg)||Standard Deviation|Mean
1216362|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216363|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216364|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216365|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216366|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216367|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216368|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)-Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216369|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216370|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216371|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216372|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216373|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216374|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216375|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216376|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216377|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216378|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216379|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216380|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216381|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216382|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216383|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216384|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216385|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216386|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216387|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216388|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216389|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216390|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216391|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216392|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216393|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216394|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216395|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216396|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216397|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216398|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216399|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216401|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216402|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216403|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216404|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216405|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216406|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216407|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216408|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216409|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216410|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216411|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216412|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216413|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216414|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216415|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216416|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1216417|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).|3 months||||Log cfu (Colony Forming Units)||Standard Error|Least Squares Mean
1216418|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|6 months||||Units on a scale||Standard Deviation|Mean
1216419|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|3 months||||Units on a scale||Standard Deviation|Mean
1216451|NCT00762463|Secondary|Percentage of Participants With Concomitant Use of Paracetamol|Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6|Week 6|FAS|||percentage of participants|||Number
1216420|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.|6 months||||Units on a scale||Standard Deviation|Mean
1216421|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.|3 months||||Units on a scale||Standard Deviation|Mean
1216422|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months||||units on a scale||Standard Deviation|Mean
1216423|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months||||units on a scale||Standard Deviation|Mean
1216424|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months||||units on a scale||Standard Deviation|Mean
1216425|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation–slight change in color and little change in texture,2 = Moderate inflammation–moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation–marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months||||units on a scale||Standard Deviation|Mean
1216426|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months||||units on a scale||Standard Deviation|Mean
1216427|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months||||units on a scale||Standard Deviation|Mean
1216428|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months||||units on a scale||Standard Deviation|Mean
1216429|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months||||units on a scale||Standard Deviation|Mean
1216430|NCT00762606|Secondary|Corneal Astigmatism|Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.|3 months after surgery||||Diopters||Standard Deviation|Mean
1216431|NCT00762606|Primary|Posterior Capsule Opacification Evaluation|The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.|12 months after surgery||||participants|||Number
1216432|NCT00762528|Primary|8-iso-prostaglandinF2α (8-iso-PGF2α)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1216433|NCT00762528|Primary|Nuclear Factor Kappa B Ligand (RANK-L)|Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1216452|NCT00762463|Secondary|Change From Baseline in CRP at Week 12|CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mg/L||Standard Deviation|Mean
1216434|NCT00762528|Primary|Interleukin-6 (IL-6)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1216435|NCT00762528|Secondary|Bleeding on Probing (BOP)|Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.|29 days||||Units on a scale||Standard Deviation|Mean
1216436|NCT00762528|Secondary|Dental Plaque Index (PI)|measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.|29 days||||Units on a scale||Standard Deviation|Mean
1216437|NCT00762528|Primary|Interleukin - 1 Beta (IL-ß)|Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1216438|NCT00762528|Primary|Prostaglandin E2 (PGE2)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1216439|NCT00762528|Primary|Gingival Index (GI)|"Gingival Index(GI)recorded on scale of 0-3 detailed below:~0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed"|29 days||||units on a scale||Standard Deviation|Mean
1216440|NCT00762515|Secondary|Control Gingivitis in Adults|Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).|6 weeks||||Units on a scale||Standard Deviation|Mean
1216441|NCT00762515|Primary|Control Established Plaque in Adults|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.|6 weeks||||Units on a scale||Standard Deviation|Mean
1216442|NCT00762502|Primary|Tarsal Roughness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
1216443|NCT00762502|Primary|Bulbar Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
1216444|NCT00762502|Primary|Limbal Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
1216445|NCT00762502|Primary|Corneal Staining|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
1216446|NCT00762476|Secondary|Rhinovirus-associated Colds|The incidence of rhinovirus-associated cold illnesses.|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||RV-associated cold illnesses per 100 sub|||Number
1216447|NCT00762476|Secondary|Rhinovirus Infections.|The incidence of rhinovirus infections|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||rhinovirus infections per 100 subjects|||Number
1216448|NCT00762476|Primary|The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.|Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||cold illnesses per 100 subjects|||Number
1216449|NCT00762463|Secondary|Paracetamol Tablets Taken Per Day by Participant|Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.|Week 6|FAS|||tablets per day||Standard Deviation|Mean
1216454|NCT00762463|Secondary|Change From Baseline in ESR at Week 12|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm/h||Standard Deviation|Mean
1216455|NCT00762463|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6|Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline <0 indicated improvement.|Baseline, Week 6|FAS|||mm/h||Standard Error|Least Squares Mean
1216456|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Week 12|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||cm||Standard Deviation|Mean
1216457|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Weeks 2, 4, and 6|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (>) 0 represented improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||cm||Standard Error|Least Squares Mean
1216458|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Week 12|Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline <0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||cm||Standard Deviation|Mean
1216459|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6|Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||cm||Standard Error|Least Squares Mean
1216460|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Week 12|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
1216461|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
1216462|NCT00762463|Secondary|Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20|Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).|Weeks 2, 4, 6, 12|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||percentage of participants|||Number
1216463|NCT00762463|Secondary|Change From Baseline in BASDAI at Week 12|BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
1216464|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6|Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
1216465|NCT00762463|Secondary|Change From Baseline in BASFI at Week 12|BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
1216466|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6|Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
1216467|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12|5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||units on a scale||Standard Deviation|Mean
1222374|NCT00720330|Secondary|Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents|The cumulative opioid consumption is calculated as fentanyl equivalent|From admission to the end of surgery||||mcg||Standard Deviation|Mean
1216468|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6|5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||units on a scale||Standard Error|Least Squares Mean
1216469|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||units on a scale||Standard Deviation|Mean
1216470|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||units on a scale||Standard Error|Least Squares Mean
1216471|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
1216472|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of <0 indicated improvement."|Baseline, Weeks 2, 4|Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
1216473|NCT00762463|Primary|Participant's Assessment of Global Pain Intensity at Baseline|"100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain."|Baseline|PP|||mm||Standard Deviation|Mean
1216474|NCT00762463|Primary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6|"100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement."|Baseline, Week 6|Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.|||mm||Standard Error|Least Squares Mean
1216475|NCT00762450|Primary|ph of Dental Plaque After Sucrose Challenge|Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.|1 week||||ph of dental plaque||Standard Deviation|Mean
1216476|NCT00762424|Primary|Time of Stone Passage|Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.|10 Days||||hours||Inter-Quartile Range|Median
1216477|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1216478|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1216479|NCT00762411|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino acid peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1216480|NCT00762411|Secondary|Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1222375|NCT00720330|Primary|Postoperative Opioid Consumption in Oral Oxycodone Equivalents|The cumulative opioid consumption after surgery until the end of second postoperative day.|2 days after surgery||||mg||Full Range|Mean
1216481|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1216482|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1216483|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug|Used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges: 0 to 30. Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1216484|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug|Assess QoL for AD; participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares Mean value controlled for baseline, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but QoL-AD not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1216485|NCT00762411|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges: 0 to 100. Lower scores=greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1216486|NCT00762411|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug|Assesses healthcare resource utilization (formal and informal care). Information gathered on both care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1216487|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. The Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1216510|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216488|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug|Semi-structured interview. Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains; total score (SB) ranges: 0 to 18. Higher scores=greater disease severity. Least Squares Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1216489|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
1216490|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma which is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.|||liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1216491|NCT00762411|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1216492|NCT00762411|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer’s participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1216493|NCT00762411|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of right and left hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
1216494|NCT00762411|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||ratio||Standard Error|Least Squares Mean
1216495|NCT00762411|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1216496|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1216497|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks|Assess QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant’s primary caregiver asked to complete same measure. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1216498|NCT00762411|Secondary|Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1216499|NCT00762411|Secondary|Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||number of hospitalizations||Standard Error|Least Squares Mean
1216500|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1216501|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1216502|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1216503|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1216504|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug|The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1216505|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks|The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1216506|NCT00762385|Primary|Comfort Symptoms|A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable|1-week, 2-weeks|Only participants who completed the study per protocol (n=78)|||score||Standard Error|Least Squares Mean
1216507|NCT00762385|Secondary|Overall Corneal Staining|Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|2 weeks|Only the participants who completed the study per protocol (n=78)|||combined score||Standard Error|Least Squares Mean
1216508|NCT00762385|Primary|Lens Comfort|>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.|1-week, 2- weeks|Only participants who completed the study per protocol (n=78)|||combined score||Standard Error|Least Squares Mean
1216509|NCT00762359|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|18 Months||||participants|||Number
1222418|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 2 Years|Number of participants with clinically significant infections at 2 years|2 years post transplant||||Participants|||Count of Participants
1216511|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216512|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216513|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216514|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216515|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216516|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216517|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216518|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216519|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216520|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216521|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216522|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216523|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216524|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216525|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216526|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216527|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216528|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216529|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216530|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216531|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216532|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216533|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216534|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216535|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216536|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216537|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216538|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216539|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216540|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216541|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216542|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216543|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216544|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216545|NCT00762359|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Values are from the Full Analysis Set.|||participants|||Number
1216556|NCT00762359|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Participants not taking investigational drug were not included.|||participants|||Number
1216546|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216547|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216548|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216549|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216550|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216551|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216552|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216553|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216554|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Median
1216555|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1216557|NCT00762320|Secondary|Parent Satisfaction|Parent Satisfaction Survey. Eight item Likert scale of parent/guardian satisfaction with the child's HIV treatment regimen. Item scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 4 week, 12 weeks and 24 weeks||||Score on a survey||Standard Deviation|Mean
1216558|NCT00762320|Primary|Lopinavir and Ritonavir AUC on Low Dose Tablet|Lopinavir and Ritonavir AUC at 4 weeks when participants are receiving the study intervention, low dose tablet formulation of Kaletra. Data collection points for AUC were 0, 2, 4, 6, and 8 hours post dose.|4 weeks|All participants were analyzed|||hr*ng/ml||Standard Deviation|Median
1216559|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks|Lpv and rtv Cmax at 4 weeks when participants are receiving study intervention, low dose Kaletra. Time points for data collection: 0, 2hrs, 4hrs, 6hrs, 8hrs|4 weeks|All participants were analyzed|||ng/ml||Standard Deviation|Median
1216560|NCT00762320|Primary|Viral Load (VL)|Number of participants who maintained their Viral load undetectable (< 20 copies/ml) for the duration of the study|Baseline, Week 4, Week 12 and Week 24|All subjects in study were analyzed|||participants|||Number
1216561|NCT00762320|Secondary|Symptoms Across All Patients|Cumulative tally of symptoms for each patients across all visits. Targetted symptoms were asked for at each visit and patients and parents were encouraged to report additional symptoms that were experienced. Each patient got a score for the total number of symptoms at each visit. Scores were totalled, but it the same symptoms occurred continuously it was counted as 1 symptom.|Baseline, 1 month, 3 months, 6 months|All participants analyzed|||numer of symptoms||Standard Deviation|Mean
1216562|NCT00762320|Secondary|Patient Satisfaction|Patient Satisfaction Survey. Eight item Likert scale of patient satisfaction with their HIV treatment regimen for patients 7 years of age and older. Items scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 1 month|Patients had to be able to read and write to complete the patient satisfaction questionnaire, so an arbitrary age of 7 was selected and patients under the age of 7 did not complete the patient satisfaction questionnaire. All 5 of the patients over the age of 5 completed the questionnaire and were analyzed.|||units on a scale||Standard Deviation|Mean
1216563|NCT00762320|Primary|Lopinavir AUC Ratio of Baseline:Week 4|Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet). AUC data were collected at 0, 2, 4, 6, and 8 hours post dose.|Baseline, week 4||||ratio||Standard Deviation|Mean
1216564|NCT00762320|Primary|Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra|Area under the curve values for lopinavir at baseline when participants are taking liquid Kaletra as part of their baseline treatment. Time points for data collection: 0, 2 hrs post, 4 hrs post, 6 hrs post, 8 hrs post.|Baseline|All participants were analyzed|||hr*ng/ml||Standard Deviation|Median
1216565|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid|Cmax values at baseline (participants are taking liquid Kaletra as part of baseline treatment). Time points for data collection: 0, 2hrs post dose, 4 hrs post dose, 8 hrs post dose.|Baseline|All participants were analyzed|||ng/ml||Standard Deviation|Median
1216566|NCT00762320|Primary|Absolute CD4 and CD4 %|Number of participants who had no clinically significant deterioration in absolute CD4 and % CD4 count for the duration of the study. Absolute CD4 and Percent CD4 counts were determined by single or dual platform analysis performed on blood samples by Phoenix Children's Hospital Laboratory, Sonora Quest Laboratory or Labcorp Laboratory. Clinically significant change was determine to be a deterioration in both Absolute CD4 to less than 500 and %CD4 to less than 25%.|Baseline, 4 weeks, 12 weeks, 26 weeks|All participants were analyzed.|||participants|||Number
1216567|NCT00762268|Secondary|YMRS||6-weeks|||||||
1216568|NCT00762268|Secondary|HAM-D||6-weeks|||||||
1216569|NCT00762268|Primary|MADRS|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.|At each weekly visit for 4 weeks||||units on a scale||Full Range|Mean
1216570|NCT00762229|Secondary|Total Cholesterol|Total cholesterol fasting|4 weeks||||mg/dL||Standard Deviation|Mean
1216571|NCT00762229|Primary|LDL Cholesterol|LDL cholesterol|4 weeks||||mg/dL||Standard Deviation|Mean
1216572|NCT00762216|Secondary|Residual Refractive Cylinder|The refractive astigmatism 6 months post-surgery, measured in diopters.|6 Months post-surgery|69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.|||diopters||Standard Error|Mean
1216573|NCT00762216|Primary|Rotational Stability|Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.|6 Months post-surgery|67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.|||degrees||Standard Error|Mean
1216574|NCT00762177|Primary|Antimicrobial Species on the Cheek(Veillonella)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216575|NCT00762177|Primary|Antimicrobial Species in Tongue(Veillonella)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216634|NCT00762034|Secondary|Number of Participants Receiving Concomitant Medication||Baseline to study endpoint (up to 37.06 months)|All randomized participants|||participants|||Number
1216635|NCT00762034|Secondary|Number of Participants Who Received a Transfusion||Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1216576|NCT00762177|Primary|Antimicrobial Species in Saliva(Veillonella)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216577|NCT00762177|Primary|Antimicrobial Species in Plaque(Veillonella)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216578|NCT00762177|Primary|Antimicrobial Species on the Cheek(Sulfur Bacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216579|NCT00762177|Primary|Antimicrobial Species in Tongue(Sulfur Bacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216580|NCT00762177|Primary|Antimicrobial Species in Saliva(Sulfur Bacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216581|NCT00762177|Primary|Antimicrobial Species in Plaque(Sulfur Bacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216582|NCT00762177|Primary|Antimicrobial Species on the Cheek(Oral Streptococci)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216583|NCT00762177|Primary|Antimicrobial Species in Tongue(Oral Streptococci)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216584|NCT00762177|Primary|Antimicrobial Species in Saliva(Oral Streptococci)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216585|NCT00762177|Primary|Antimicrobial Species in Plaque(Oral Streptococci)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216586|NCT00762177|Primary|Antimicrobial Species on the Cheek(Fusobacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216587|NCT00762177|Primary|Antimicrobial Species in Tongue(Fusobacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216588|NCT00762177|Primary|Antimicrobial Species in Saliva(Fusobacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216589|NCT00762177|Primary|Antimicrobial Species in Plaque(Fusobacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216590|NCT00762177|Primary|Antimicrobial Species on the Cheek(Total Anaerobic)|After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216887|NCT00760266|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8||Baseline and Week 8|Full analysis set, restricted for msDBP to those with baseline msDBP at least 90 mm Hg)|||mm Hg||Standard Error|Least Squares Mean
1216591|NCT00762177|Primary|Antimicrobial Species in Tongue(Total Anaerobic)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216592|NCT00762177|Primary|Antimicrobial Species in Saliva(Total Anaerobic)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216593|NCT00762177|Primary|Antimicrobial Species in Plaque(Total Anaerobic)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216594|NCT00762177|Primary|Antimicrobial Species on the Cheek(Actinomyces)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216595|NCT00762177|Primary|Antimicrobial Species on the Tongue(Actinomycetes)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216596|NCT00762177|Primary|Antimicrobial Species in Saliva(Actinomyces)|Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216597|NCT00762177|Primary|Antimicrobial Species in Plaque(Actinomyces)|After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1216598|NCT00762164|Secondary|Total Cholesterol||6 weeks||||% change in total cholesterol||Standard Deviation|Mean
1216599|NCT00762164|Primary|LDL Cholesterol||6 weeks||||% change in LDL cholesterol||Standard Deviation|Mean
1216600|NCT00762086|Primary|Absolute Claudication Distance (ACD)|Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters|3 months|ITT cohort|||Meters||Standard Error|Least Squares Mean
1216601|NCT00762073|Secondary|Mean Change in Blood Pressure (BP) at End of Treatment|BP was assessed for each treatment group at baseline and at each post-baseline visit including the final treatment evaluation.|Baseline, 12 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.|||mmHg||Standard Deviation|Mean
1216602|NCT00762073|Secondary|Percent of Participants With Potential Corticosteroid-Related Treatment-Emergent Adverse Events (TEAEs)|Corticosteroid-Related TEAEs included candidiasis, oesophageal candidiasis, crying, psychomotor hyperactivity, aggression, anger, anxiety, conduct disorder, emotional disorder, insomnia, or mood altered mood. Corticosteroid-Related TEAEs were assessed systematically during the treatment and taper periods.|15 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.|||percentage of participants|||Number
1216603|NCT00762073|Secondary|Area Under The Plasma Concentration-Time Curve (AUC) of Budesonide From Time Zero to Time of The Last Measurable Concentration (AUC0-last)|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||hr*pg/mL||Standard Deviation|Mean
1216604|NCT00762073|Secondary|Time to Maximum (Tmax) And Half Maximum (T1/2) Plasma Concentration of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together. T1/2 is the time to terminal elimination half-life.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||hours||Standard Deviation|Mean
1216888|NCT00760266|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set, restricted to baseline msDBP >= 90 mmHg|||mm Hg||Standard Error|Least Squares Mean
1216605|NCT00762073|Secondary|Maximum Plasma Concentration (Cmax) of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The Pharmacokinetic (PK) Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||pg/mL||Standard Deviation|Mean
1216606|NCT00762073|Secondary|Change From Baseline in Physician's Global Assessment Score of Disease Severity|"Physician investigators were asked to complete a visual analog scale (VAS) to provide a global assessment of eosinophilic esophagitis (EoE) activity in each participant. The VAS was a 100-mm horizontal line on which the right extreme (100) was labeled “worst possible disease activity” and the left (0) was labeled “no disease activity.” Investigators were instructed to consider the line for the VAS as a continuum with their own opinion of extremes on either end. Investigators drew a vertical line at a point that best approximated the participant's current level of EoE disease activity. The investigator was to take into consideration how esophageal disease was impacting the participant’s daily activities. The following instruction was given to the investigators: Using the visual analog scale below, please mark a vertical line on the scale to indicate your assessment of EoE activity in this participant at this time. A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||scores on a scale||Standard Deviation|Mean
1216607|NCT00762073|Secondary|Percent Change From Baseline in Eosinophilic Esophagitis (EoE) Clinical Symptom Score (CSS)|"The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1= Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2= Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3= Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors.~A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percent change||Standard Deviation|Mean
1216608|NCT00762073|Secondary|Percent of Participants With Clinical Remission|"Clinical remission was defined as an eosinophilic esophagitis (EoE) clinical symptom score (CSS) of zero. EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1216609|NCT00762073|Secondary|Percent of Participants With Clinical Response|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS). The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1216610|NCT00762073|Secondary|Change From Baseline in Endoscopy Score|Esophageal endoscopy was used to assess the level of inflammation and eosinophilia. Four categories of endoscopic findings were evaluated and scored for this study: (1) pallor and diminished vascular markings; (2) furrowing with thickened mucosa; (3) presence of white mucosal plaques; and (4) concentric rings or strictures. For each category, 0 points were allocated if no esophageal sites were involved, 1 point if 1 or 2 esophageal sites were involved, and 2 points for pan-esophageal involvement (see Aceves et al., 2007). The maximum possible endoscopy score was 8 points. A negative change from baseline indicates that esophageal inflammation decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||scores on a scale||Standard Deviation|Mean
1216611|NCT00762073|Secondary|Percent Change From Baseline in Peak Eosinophil Count|The maximum peak number of eosinophils at baseline and at the final treatment evaluation was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value. A negative change from baseline indicates that eosinophil count has decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percent change||Standard Deviation|Mean
1216889|NCT00760266|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
1216612|NCT00762073|Secondary|Percent of Participants With Histologic Remission|Histologic remission was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤1 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1216613|NCT00762073|Secondary|Percent of Participants With Histologic Response|Histologic response was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤6 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1216614|NCT00762073|Primary|Percent of Participants Who Responded to Therapy|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS) and a reduction in peak eosinophil count to ≤6/high power field (light microscopy) from esophageal biopsies collected at the final evaluation. The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The Full Analysis Set (FAS), defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1216615|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression|Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score >0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with FR-α Cytoplasm or Membrane H scores. Participants censored: FR-α Positive Cytoplasm n=21, 15 and Negative n=4, 3; FR-α Membrane Positive n=16, 8 and Negative n=9, 10 for Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1216616|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression|Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score >0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TS Cytoplasm and Nucleus H scores. Participants censored: TS Cytoplasm Positive n=23, 20 and Negative n=4, 1; TS Nucleus Positive n=17, 9 and Negative n=10, 12 for the Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1216617|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment|Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score >0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TTF-1 H scores regardless of study treatment. Participants censored: n=38, 11 in the TTF-1 Nuclear Positive and Negative arms, respectively.|||months||95% Confidence Interval|Median
1216618|NCT00762034|Secondary|Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations|Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).|Baseline|All randomized participants with EGFR data regardless of study treatment.|||participants|||Number
1216619|NCT00762034|Secondary|Pharmacokinetics (PK): Bevacizumab Clearance (CL)||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.|||liters per day (L/day)||Geometric Coefficient of Variation|Geometric Mean
1216620|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.|||microgram*day per milliliter (μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
1216621|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.|||days||Geometric Coefficient of Variation|Geometric Mean
1216622|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1216623|NCT00762034|Secondary|Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1216624|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.|||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1216625|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
1216626|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1216627|NCT00762034|Secondary|Pharmacokinetics (PK): Pemetrexed Clearance (CL)||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable CL data.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1216628|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable AUC(0-∞) data.|||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1216629|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable t1/2 data.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
1216630|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1216631|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)|FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items; each uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT/GOG-Ntx data, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
1216632|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)|FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items. Each item uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-L, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
1216633|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)|"The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction."|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-G data, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
1216636|NCT00762034|Secondary|Duration of Hospitalizations Per Participant|Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug and had at least one hospitalization while on study or within 30 days of discontinuation.|||days||Standard Deviation|Mean
1216637|NCT00762034|Secondary|Safety and Toxicity Profile of Study Treatments|Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug during the specified treatment phase.|||participants|||Number
1216638|NCT00762034|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=198, 172 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1216639|NCT00762034|Secondary|Progression Free Survival Time|Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=127, 109 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1216640|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)|Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle|||percentage of participants||95% Confidence Interval|Number
1216641|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)|Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle|||percentage of participants||95% Confidence Interval|Number
1216642|NCT00762034|Primary|Overall Survival|Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=131, 127 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1216643|NCT00762021|Primary|9% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background.~VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.|||LogMAR||Standard Deviation|Mean
1216644|NCT00762021|Primary|100% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background.~VA is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.|||LogMAR||Standard Deviation|Mean
1216645|NCT00762021|Primary|Posterior Capsule Opacification (PCO)|Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.|2 years after surgery|Data for all patients completing the 24 month visit were analyzed.|||Percentage of PCO||Standard Deviation|Mean
1216646|NCT00761969|Secondary|Incidence of Revascularization Procedures|Incidence of coronary, carotid and peripheral arterial revascularization procedures|5 years||||participants|||Number
1216647|NCT00761969|Primary|Incidence of Major Cardiovascular Events|Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.|5 years:||||participants|||Number
1216926|NCT00759902|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||ng/mL||Standard Deviation|Mean
1222419|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 1 Year|Number of participants with clinically significant infections at 1 year|1 year post transplant||||Participants|||Count of Participants
1216648|NCT00761956|Secondary|Return to Function (RtF) Via Knee Scoiety Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.~Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|24 Months|There was one case in the CR Flex Fixed cohort and 3 in the CR Standard Knee cohort where the Return to Function was not complete. Therefore, the total number analyzed is 51 instead of 52 and 45 instead of 48 respectfully.|||units on a scale||Standard Deviation|Mean
1216649|NCT00761956|Primary|Postoperative Range of Motion (ROM)|The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.|24 Months|There was one case in the CR Standard Knee cohort where the Range of Motion was not complete. Therefore, the total number analyzed is 47 and not 48.|||degrees||Standard Deviation|Mean
1216650|NCT00761930|Primary|Bleeding Index (EIBI)|Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.|6 weeks||||Units on a scale||Standard Deviation|Mean
1216651|NCT00761930|Primary|Gingivitis Score|"Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored."|6 weeks||||Units on a scale||Standard Deviation|Mean
1216652|NCT00761930|Primary|Dental Plaque|Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.|6 weeks||||Units on a scale||Standard Deviation|Mean
1216653|NCT00761865|Secondary|Patient Satisfaction (Measured on a Visual Analog Scale)|Satisfaction on 0-10 scale with 10 being the best.|2 weeks post-sprain||||units on a scale||Full Range|Mean
1216654|NCT00761865|Primary|Modified Karlsson Score|Ankle function score - range 0 to 100. Higher score is better ankle function.|2 weeks post-sprain||||units on a scale||Full Range|Mean
1216655|NCT00761813|Secondary|Complications, Including Avascular Necrosis, Nonunion, and Infection||Measured 2 years after original surgery||||participants|||Number
1216656|NCT00761813|Secondary|Quality of Life|The SF-12 PCS is the short form - 12 Health Survey Physical component summary - 0 is bad and 100 is good The WOMAC is Western Ontario and McMaster Universities Osteoarthritis Index 0 is good and 100 is bad The EQ-5D is EuroQol5D 1 is good and 5 is bad|Measured 2 years after original surgery|secondary outcomes not given or completed to all subjects|||units on a scale||Standard Deviation|Mean
1216657|NCT00761813|Primary|Revision Surgery|Additional Surgery on the affected hip|Measured 2 years after original surgery||||Participants|||Count of Participants
1216658|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
1216659|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
1216660|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
1216661|NCT00761774|Primary|Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1216662|NCT00761774|Primary|Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1222420|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 6 Months|Number of participants with clinically significant infections at 6 months|6 months post transplant||||Participants|||Count of Participants
1216663|NCT00761774|Primary|Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1216664|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms|Symptoms of anxiety were measured using the Hamilton Anxiety Rating Scale (HARS). Minimum score = 0, Maximum score = 60. Higher scores on HARS indicate worse functioning|Baseline and 8 week treatment|Stable Bipolar Patients|||units on a scale||Standard Deviation|Mean
1216665|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.|Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.|Baseline and 8 weeks treatment|Stable Bipolar Patients|||units on a scale||Standard Deviation|Mean
1216666|NCT00761761|Secondary|Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms|Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Minimum score = 0, Maximum score = 60. Higher scores on MADRS indicate worse functioning.|Baseline and 8 week treatment|Stable Bipolar patients|||units on a scale||Standard Deviation|Mean
1216667|NCT00761761|Primary|Change From Baseline in Digit-Span Score at 8 Weeks|"Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al, 2012). However, the results for Digit span which assesses short term or working memory are presented.~The raw scores for digit span ranges from a minimum of 2 to a maximum of 8. The Digit Span test measures working memory and the longer the span the better the cognition therefore the higher score is the better outcome."|8 week treatment||||units on a scale||Standard Error|Least Squares Mean
1216668|NCT00761748|Primary|Preference of the Two Urostomy Products|"Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.~The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred."|6 weeks|The Per protocol (PP) population is analysed. PP-criteria: Subjects fulfill the inclusion and exclusion criteria, do not seriously violate the protocol, are exposed to both products and are evaluable with respect to the primary endpoint (state preference). *One drop out was evaluable, as the subject tried both products and stated a preference.|||participants|||Number
1216669|NCT00761735|Primary|Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender|The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.|Last assessment of the Part 2 LTFU (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU with non-missing Tanner Stage data at the last observation (up to Year 5 of the LTFU) were analyzed.|||years||Standard Deviation|Mean
1216670|NCT00761735|Primary|Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
1216671|NCT00761735|Primary|Mean Weight Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
1216672|NCT00761735|Primary|Mean Height Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
1216673|NCT00761735|Primary|Number of Participants Who Relapsed At End of LTFU Year 5|Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.|Part 2 LTFU Year 5|Of 94 participants entering the P02538 Part 2 LTFU, 63 participants had achieved sustained virologic response (SVR) while in Part 1 of the study. 54 of these 63 participants completed 5 years of LTFU and were evaluated for relapse.|||participants|||Number
1216706|NCT00761527|Secondary|Investigator Assessment of Clinical Efficacy|Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15.|Day 15|ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported.|||Participants|||Number
1216674|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2|Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
1216675|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1|Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary.|From the day of dose 1 (Day 1) to Day 7 of dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
1216676|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
1216677|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 1 (Day 1) to Day 7 after dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
1216678|NCT00761631|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4|Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3 and 4|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with a determinate antibody titer.|||titer||95% Confidence Interval|Geometric Mean
1216679|NCT00761631|Primary|Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)|Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.|28 to 42 days after dose 1|||||||
1216680|NCT00761631|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3|Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.|||mcg/mL||95% Confidence Interval|Geometric Mean
1216681|NCT00761631|Primary|Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2|Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.|28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2|Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1216682|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1216683|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1216684|NCT00761605|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1216685|NCT00761605|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Millimeter (mm)||Standard Deviation|Mean
1216686|NCT00761605|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Millimeter (mm)||Standard Deviation|Mean
1216687|NCT00761605|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1216688|NCT00761605|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1216719|NCT00761306|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
1217691|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1216689|NCT00761605|Primary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1216690|NCT00761592|Secondary|Duration of Action|Median Duration for decision to reinject|Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)|Intention to Treat|||Weeks||Standard Deviation|Median
1216691|NCT00761592|Secondary|Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score|"Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect~+1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement."|Baseline to Week 4 and 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
1216692|NCT00761592|Secondary|Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)|Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open > 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.|Baseline to Week 4 and Week 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
1216693|NCT00761592|Secondary|Change From Baseline to Week 8 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point (0-4) scale with six items (e.g., reading, driving a vehicle).~0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.~The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
1216694|NCT00761592|Primary|Change From Baseline to Week 4 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle).~0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.~The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 4|Intention to Treat|||Points on Scale||Standard Deviation|Mean
1216695|NCT00761579|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1216696|NCT00761579|Secondary|Change From Baseline in Sleep Quality at Week 48|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||millimeter (mm)||Standard Deviation|Mean
1216697|NCT00761579|Secondary|Change From Baseline in Daytime Drowsiness at Week 48|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||millimeter (mm)||Standard Deviation|Mean
1216720|NCT00761306|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)|||units on a scale||Standard Deviation|Mean
1216721|NCT00761306|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS|||percentage of patients|||Number
1216698|NCT00761579|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1216699|NCT00761579|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1216700|NCT00761579|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1216701|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1216702|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1216703|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1216704|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1216705|NCT00761527|Primary|Participant Global Tolerability Assessment|"The participant’s global assessment of tolerability with the medication was assessed using a categorical scale as follows:~Excellent~Very Good~Good~Fair~poor~Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented."|Day 15|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed.|||Participants|||Number
1216707|NCT00761527|Primary|Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment|Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.|||Participants|||Number
1216708|NCT00761527|Primary|Number of Adverse Events Reported By Category After 14 Days of Treatment|Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.|||Adverse Events|||Number
1216709|NCT00761514|Primary|Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities.|Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.|Week 24 of treatment|Available subject data were used in calculations; 14 at Baseline and 7 at Week 24. Missing data were not imputed.|||Percent change in average total score|||Number
1216710|NCT00761514|Secondary|Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score|On visual analog scale (VAS), patient marks activity of rheumatoid arthritis in previous 24 hours (0 mm=no symptoms; 100 mm=very active). On another VAS, patient marks how much pain (0 mm=no pain; 100 mm=severe pain) he/she had because of the illness in previous week. Patient also marks tender joints and swollen joints on body diagrams. Number of swollen and painful joints and values on VAS are used with erythrocyte sedimentation rate to calculate the patient's global assessment of disease activity. High score indicates high activity.|Week 24 of treatment|Available subject data were used in calculations. Missing data were not imputed.|||Percent change in average score|||Number
1216711|NCT00761462|Primary|Incidence of Nervous System Events (Cumulative)|Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug).|||participants|||Number
1216712|NCT00761462|Primary|Incidence of Arthropathy (Cumulative)|Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug)|||participants|||Number
1216713|NCT00761345|Secondary|To Measure Progression Free Survival and Overall Survival||Evaluate CT scans after every 2 cycles of therapy (about every 6 weeks) and long term follow up every 3 months once off treatment for survival|||||||
1216714|NCT00761345|Primary|To Determine the Dose Limiting Toxicities||weekly physician and nurse assessment and in between as needed until 30 days after treatment termination|27 patients (median age 64years and 15 male) with locally advanced or metastatic pancreatic cancer confined to the abdomen and an ECOG performance status of 0-1 who had received 0-1 prior regimens (without Gemcitabine or Erlotinib) and no prior radiotherapy were eligible.|||participants|||Number
1216715|NCT00761319|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.|Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.|||Percentage of patients|||Number
1216716|NCT00761319|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.|Day 0, Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.|||Units on a scale||Standard Error|Mean
1216717|NCT00761306|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC|||percentage of patients|||Number
1216718|NCT00761306|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC|||percentage of patients|||Number
1216722|NCT00761306|Primary|Number of Patients With Adverse Events (AEs)||Up to 52 weeks and a 4-week safety follow-up period|APTS|||participants|||Number
1216723|NCT00761280|Secondary|Median Time to Progression (Days) by Independent Review for the Intent-to-treat Population (Descriptive Analysis, Only)|Time to progression was calculated from the date of randomization to the date of the first documented tumor progression. Participants who did not progress or died were censored at the last tumor assessment date or the date of start of a new anti-tumor treatment or death.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||days||95% Confidence Interval|Median
1216724|NCT00761280|Secondary|Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|"Tumor response was classified based on the (neuro-)radiologist’s evaluation:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21 and 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
1216725|NCT00761280|Secondary|Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist’s evaluation:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21, and 24 months|The Intent-to-treat population includes all participants randomized.|||participants|||Number
1216726|NCT00761280|Secondary|Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only)|"Duration of response was defined as the time from the first documentation of confirmed response (Complete Response, CR, or Partial Response, PR) to the first signs of Progressive Disease (PD), as assessed by the study neuro-oncologist. Median Duration of Response was calculated by Kaplan-Meier estimate.~Censoring rules were:~at the date of randomization -- participants without baseline assessments, or for those with no post-baseline timor assessments who were discontinued for other than progressive disease or death.~at the date of last tumor assessment -- discontinuation other than PD or death, or if a new treatment was started prior to disease progression~at the date of death or last tumor assessment -- death or PD after one missed tumor assessment~at the date of last tumor assessment -- death or PD after more than one missed tumor assessment~at the date of last tumor assessment -- participants on ongoing treatment at data cut-off"|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||days||95% Confidence Interval|Median
1216727|NCT00761280|Primary|Survival at 24 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at 24 months from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to / insufficient follow-up includes participants who were alive at last data collection point but did not yet have enough follow-up time to reach the 24 month time point."|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||participants|||Number
1216728|NCT00761280|Secondary|Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Tumor control rate was defined as the proportion of participants assessed as having Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Participants with unknown or missing response were treated as non-responders.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
1216729|NCT00761280|Secondary|Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Overall response rate was the proportion of participants with a best response of Complete Response (CR) or Partial Response (PR) observed from the start of treatment until disease progression.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
1216730|NCT00761280|Secondary|Response Category by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist’s evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Two qualified neuro-radiologists reviewed scans at each MRI time point, with adjudication of discrepancies by a third reviewer. Their findings and clinical information were independently reviewed by a neuro-oncologist, who made the assessment of overall response."|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||participants|||Number
1216927|NCT00759863|Secondary|Center for Epidemiologic Studies Depression Scale|The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The construct being assessed is the caregiver depression. Best value = 0. Worst Value = 60.|6 months||||Units on a scale||Standard Deviation|Mean
1216731|NCT00761280|Secondary|Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only)|Median overall survival was defined as the date of randomization to the date of death. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. Analysis was by Kaplan-Meier estimation.|Up to 24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||days||95% Confidence Interval|Median
1216732|NCT00761280|Secondary|Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to follow-up for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point."|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||participants|||Number
1216733|NCT00761280|Secondary|Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||percentage of participants||95% Confidence Interval|Number
1216734|NCT00761280|Primary|Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||percentage of participants||95% Confidence Interval|Number
1216735|NCT00761267|Secondary|All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits||Overall treatment period (up to 49 days); during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)|The safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1216736|NCT00761267|Secondary|Percentage of Participants With New Infection|New infection was defined as a participant presenting with clinical failure with the emergence of new Candida species at the original site of infection or at a distant site of infection. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection occurred. Participants had received at least 3 doses of study medication to be classified as a failure. End of treatment visit defined as last day of study treatment (IV or oral).|During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)|The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.|||percentage of participants|||Number
1216737|NCT00761267|Secondary|Percentage of Participants With Relapsed Response|Relapse was defined as any baseline Candida species isolated following eradication (documented or presumed); or culture data not available for a participant with a clinical response of failure after a previous response of success. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection. Participants had received at least 3 doses of study medication to be classified as a failure. Clinical response of success was defined as resolution of sign and symptoms attributed to Candida infection occurred with no additional systemic or oral antifungal treatment required to complete the course of therapy. Eradication or presumed eradication: baseline pathogen not isolated from original site culture(s), or culture data are not available for a participant with successful clinical outcome. End of treatment visit defined as last day of study treatment (IV or oral).|During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)|The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.|||percentage of participants|||Number
1216738|NCT00761267|Secondary|To Explore the Exposure-Response (Safety and Efficacy Endpoints) Relationship of Anidulafungin Using a Nonlinear Mixed Effects Approach as Appropriate, Including Exploring the Association Between PK-PD Index (eg, AUC/MIC) and Efficacy Endpoints|Data for this outcome will be estimated and reported in a separate analysis plan, and will be provided once available.|Day 1 - Day 9, at specified collection time points|||||||
1216739|NCT00761267|Secondary|Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin|Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 mg/ml. Cmax PK time points were assessed on at Day 1, Day 2, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.|Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose|The PK population for PS80 included all participants aged between 1 month to <2 years who had 1 or more PK sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1216751|NCT00761215|Secondary|Response Rate at End of Therapy|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|last day of study treatment|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection|||Percentage of participants||95% Confidence Interval|Number
1216740|NCT00761267|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin|Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 milligram per milliliter (mg/mL). AUC24 PK time points were assessed on at Day 1, Day 2, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.|Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose|The PK population for PS80 included all participants aged between 1 month to <2 years who had 1 or more PK sample available.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1216741|NCT00761267|Secondary|Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup|Cmax PK time points were assessed on Day 1 and Day 2. Summarized data for both time points was reported.|Day 1: 2 minutes before the end of infusion, Day 2: pre- infusion, 6, 12 and 24 hours after the start of infusion and 2 minutes before the end of infusion|PK subgroup population included the first 6 participants aged between 1 month to <2 years.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1216742|NCT00761267|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup|AUC24 PK time points were assessed on Day 1 and Day 2. Summarized data for both time points was reported.|Day 1: 2 minutes before the end of infusion, Day 2: pre- infusion, 6, 12 and 24 hours after the start of infusion and 2 minutes before the end of infusion|PK subgroup population included the first 6 participants aged between 1 month to <2 years.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1216743|NCT00761267|Secondary|Number of Participants With Global Response|Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection[CI]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral).|End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)|The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.|||Participants|||Count of Participants
1216744|NCT00761267|Primary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: <0.8*lower limit of normal (LLN); reticulocytes count (absolute or percent): <0.5*LLN or greater than (>) 1.5*upper limit of normal (ULN); Platelets: <0.5*LLN or >1.75*ULN; white blood cell count: <0.6*LLN or >1.5*ULN; neutrophils (absolute or percent): <0.8*LLN or >1.2*ULN; basophils (absolute or percent): >1.2*ULN; lymphocytes (absolute or percent): <0.8*LLN or >1.2*ULN; monocytes (absolute or percent): >1.2*ULN. Serum Chemistry parameters: sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, bicarbonate, calcium: <0.9*LLN or >1.1*ULN; magnesium: >1.1*ULN or <0.9*LLN; BUN (blood urea nitrogen): >1.3* ULN, creatinine: >1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : >3.0*ULN ; total bilirubin: >1.5*ULN; albumin: <0.8*LLN or >1.2*ULN and glucose: <0.6*LLN or >1.5*ULN.EOT visit defined as last day of study treatment (IV or oral).|Baseline up to 6 weeks after EOT (up to 91 days)|The safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1216745|NCT00761267|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral).|Baseline up to 6 weeks after EOT (up to 91 days)|The safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1216746|NCT00761215|Secondary|Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set||21-28 days after last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.|||Percentage of participants||95% Confidence Interval|Number
1216747|NCT00761215|Secondary|Population PK||Multiple|||||||
1216748|NCT00761215|Secondary|To Evaluate the Safety Profile of Tedizolid Phosphate||Multiple|||||||
1216749|NCT00761215|Secondary|Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set|Persistent clinical cure was defined as continuing favorable response.|21 to 28 days after the last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.|||Percentage of Participants|||Number
1216750|NCT00761215|Secondary|Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set|Satisfactory microbiological outcomes are eradication and presumed eradication|7-14 days after last dose of study drug|The microbiologically evaluable analysis set includes all participants who received study drug, had a diagnosis of complicated skin and skin structure infection, completed an assessment, had no confounding events or factors, and had a baseline Gram-positive bacterial pathogen.|||Percentage of participants||95% Confidence Interval|Number
1232659|NCT00640224|Secondary|Percent Body Fat at Baseline and 6 Months|DXA scans were done to measure the percentage of body fat.|Baseline and 6 months||||percentage of body fat||Standard Error|Mean
1216752|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7-14 days after last dose of study drug|The clinically modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection.|||Percentage of participants||95% Confidence Interval|Number
1216753|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7 to 14 days after the last dose of study drug|The Clinically Evaluable analysis set includes data from all participants who had a diagnosis of cSSSI, received minimal study therapy, completed an assessment, and had no confounding events or factors.|||Percentage of participants||95% Confidence Interval|Number
1216754|NCT00761202|Secondary|Lipid Layer Pattern Assessment|Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.|Week 1, month 1|Intent to Treat Population|||Lipid Layer Mixing Pattern||Full Range|Median
1216755|NCT00761202|Secondary|Daily Eyedrop Usage|Average daily eyedrop use|Month 1|Intent to Treat Population|||drops/day||Standard Deviation|Mean
1216756|NCT00761202|Secondary|Ocular Comfort and Ocular Symptoms on Visual Analogue Scale|Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)|week 1, month 1|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
1216757|NCT00761202|Secondary|Conjunctival Hyperaemia|Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
1216758|NCT00761202|Secondary|Corneal Staining by Fluorescein|Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
1216759|NCT00761202|Primary|Conjunctival Staining by Lissamine Green|Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
1216760|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Participants|||Number
1216761|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Participants|||Number
1216762|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Units on a scale||Standard Deviation|Mean
1216763|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Units on a scale||Standard Deviation|Mean
1216764|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1216809|NCT00760669|Primary|Overall Efficacy Assessment|The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator’s discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.|Baseline up to Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment.|||Participants|||Number
1216765|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1216766|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Percentage of Participants|||Number
1216767|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Percentage of participants|||Number
1216768|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Units on a scale||Standard Deviation|Mean
1216769|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Units on a scale||Standard Deviation|Mean
1216770|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Percentage of participants|||Number
1216771|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Percentage of participants|||Number
1216772|NCT00761176|Primary|The Incidence of Wounds Reaching Complete Closure||approximate one year|Analysis was not done as this study was early terminated due to all subjects not meeting inclusion/exclusion criteria.||||||
1216773|NCT00761150|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.|||scores on a scale||Standard Error|Least Squares Mean
1216820|NCT00760617|Secondary|HI Antibody Seroconversion Factor (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||fold increase||95% Confidence Interval|Geometric Mean
1216774|NCT00761150|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).|||scores on a scale||Standard Error|Least Squares Mean
1216775|NCT00761137|Secondary|Percentage Change in Saliva Volume|Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined.|Before and 75 minutes after treatment administration|Percentage saliva volume change was determined in the last seven (7) patients enrolled.|||percentage change of saliva volume||95% Confidence Interval|Median
1216776|NCT00761137|Primary|Sialorrhea Visual Analogue Scale (VAS)|Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.|Before and 120 min after treatment administration||||cm on VAS||Standard Deviation|Mean
1216777|NCT00761007|Secondary|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat (ITT) subgroup of patients with IBS-D (N=234)|||Participants|||Number
1216778|NCT00761007|Post-Hoc|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat subgroup of patients with IBS-D and baseline pain score>1 (in a 5-point scale ranging from 0=no pain to 4=very severe) (N=189)|||Participants|||Number
1216779|NCT00761007|Secondary|Response of Overall IBS Symptom Relief - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-Treat (N=544)|||Participants|||Number
1216780|NCT00761007|Primary|Response of Overall IBS Symptom Relief - 50% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 2/4 weeks (50% rule)"|Four weeks|Intention-to-Treat (N=544)|||Participants|||Number
1216781|NCT00760877|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Months||95% Confidence Interval|Median
1216782|NCT00760877|Secondary|Event-free Survival|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Months||95% Confidence Interval|Median
1216783|NCT00760877|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.|48 months|24 months, Non-responders|||months||95% Confidence Interval|Median
1216784|NCT00760877|Secondary|Number of Cross-over Participants With CMR|The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 months, 48 months|Participants from the Imatinib treatment group who crossed over to the Nilotinib treatment group were analyzed.|||Participants|||Number
1216785|NCT00760877|Secondary|Rate of Confirmed Best Cumulative CMR|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 month, 48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Participants|||Number
1216821|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
1216786|NCT00760877|Primary|Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|12 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Participants|||Number
1216787|NCT00760838|Secondary|Change in Total Score on the Asthma-related Quality of Life (AQLQ)|"A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease~32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items)~7-point Likert scale (7 = not impaired at all - 1 = severely impaired).~Scores range 1-7, with higher scores indicating better quality of life."|from baseline to week 26|intention to treat analysis|||units on a scale||Standard Deviation|Mean
1216788|NCT00760838|Secondary|Change in Total Score on Asthma Control Questionnaire (ACQ)|"A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.~ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff~Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)~Scores range between 0 (totally controlled) and 6 (severely uncontrolled)."|from baseline to week 26|intention to treat analysis|||units on a scale||Standard Deviation|Mean
1216789|NCT00760838|Secondary|Change in Forced Expiratory Volume in 1 Second||from baseline to week 26|intention to treat analysis|||percentage of baseline FEV1||Standard Deviation|Mean
1216790|NCT00760838|Secondary|Peakflow Measurements|change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second|from baseline to week 26|intention to treat analysis|||L/min||Standard Deviation|Mean
1216791|NCT00760838|Secondary|Proportion of Participants Using Rescue Medication From Baseline to Week 26|"proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used.~This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26."|from baseline to week 26|intention to treat analysis|||proportion of participants||Standard Deviation|Mean
1216792|NCT00760838|Primary|Proportion of Participants With Severe Asthma Exacerbations|Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.|from baseline to week 26|intention to treat analysis|||proportion of participants||95% Confidence Interval|Mean
1216793|NCT00760747|Secondary|Number of Participants With Suicidal Behaviors and Ideations|Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.|Baseline through 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||participants|||Number
1216794|NCT00760747|Secondary|Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||kilogram||Standard Deviation|Mean
1216795|NCT00760747|Primary|Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 2 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1216796|NCT00760747|Secondary|Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||beats per minute||Standard Deviation|Mean
1216797|NCT00760747|Secondary|Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||mmHg||Standard Deviation|Mean
1216798|NCT00760747|Secondary|Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint|The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1216799|NCT00760747|Secondary|Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint|CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score– Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||standard deviation units||Standard Error|Least Squares Mean
1216800|NCT00760747|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint|The CGI- S is a single-item clinician rating of the severity of the participant’s ADHD symptoms in relation to the clinician’s total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1216801|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1216802|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1216803|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1216804|NCT00760747|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1216805|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction|An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1216806|NCT00760669|Primary|Number of Participants With Adverse Drug Reactions|Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as “not related”.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1216807|NCT00760669|Primary|Number of Participants With Unexpected Adverse Events|Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1216808|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1216810|NCT00760669|Primary|Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30|The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline and Week 30|Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.||||||
1216811|NCT00760669|Primary|Change From Baseline in Number of Tender Joints at Week 30|Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Tender joints||Standard Deviation|Mean
1216812|NCT00760669|Primary|Change From Baseline in Number of Swollen Joints at Week 30|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Swollen joints||Standard Deviation|Mean
1216813|NCT00760669|Primary|Change From Baseline in C-Reactive Protein (CRP) at Week 30|The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Milligram per deciliter||Standard Deviation|Mean
1216814|NCT00760669|Primary|Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30|The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure.|||Millimeter per hour||Standard Deviation|Mean
1216815|NCT00760669|Primary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30|The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure.|||Millimeter||Standard Deviation|Mean
1216816|NCT00760617|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.|||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
1216817|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
1216818|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
1216819|NCT00760617|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||fold increase||95% Confidence Interval|Geometric Mean
1216822|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
1216823|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
1216824|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
1216825|NCT00760617|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||titers||95% Confidence Interval|Geometric Mean
1216826|NCT00760617|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
1216827|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 180 to Day 209|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1216828|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1216829|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1216830|NCT00760617|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1216831|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1216832|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1216884|NCT00760383|Primary|Stair Time up||6 weeks||||seconds||Standard Error|Mean
1222487|NCT00719329|Primary|Colonization at Day 1 Swab|Was the swab collected on the day 1 visit (usually within 24 hours of birth) positive for any organism? If so, this is defined as positive.|First week of life|Intention to Treat|||Participants|||Number
1216833|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1216834|NCT00760617|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1216835|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1216836|NCT00760617|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1216837|NCT00760617|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1216838|NCT00760578|Post-Hoc|Change From Baseline in Insulin|Change from Baseline in insulin levels following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 pre-dose laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||uIU/mL||Standard Error|Least Squares Mean
1216839|NCT00760578|Post-Hoc|Change From Baseline in FPG|Change from baseline in fasting plasma glucose (FPG) following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had Day 8 and Day 43 fasting plasma glucose values. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1216840|NCT00760578|Secondary|Change From Baseline in HDL|Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1216841|NCT00760578|Secondary|Change From Baseline in Triglycerides|Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1216842|NCT00760578|Secondary|Change From Baseline in FFAs|Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment|After 28 days of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1216843|NCT00760578|Secondary|Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test|Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test.|After four weeks of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||uIU/mL||Standard Error|Least Squares Mean
1216844|NCT00760578|Primary|Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test|Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1216845|NCT00760552|Primary|Blood Pressure Change|Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint—BP—will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).|Measured at Baseline, and 6,12,18,24, and 30 months post baseline.||||mmHg||Standard Deviation|Mean
1216885|NCT00760266|Secondary|Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8|Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg|At Weeks 4 and 8|Full analysis set|||Percentage of Participants|||Number
1216846|NCT00760526|Secondary|Parental Quality of Life Measures: CGM Satisfaction Scale|"Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)~JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679–684"|26 weeks||||units on a scale||Standard Deviation|Mean
1216847|NCT00760526|Secondary|Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1–4. Higher score denotes fewer problems in the past month.|26 weeks||||units on a scale||Standard Deviation|Mean
1216848|NCT00760526|Secondary|Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)|The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.|26 weeks||||units on a scale||Standard Deviation|Mean
1216849|NCT00760526|Secondary|Parental Quality of Life Measures: Hypoglycemia Fear Survey|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0–100 with higher score denoting more fear. The results reported below are the values at 26 weeks.|26 weeks||||units on a scale||Standard Deviation|Mean
1216850|NCT00760526|Secondary|Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)|Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||percentage of median||Inter-Quartile Range|Median
1216851|NCT00760526|Secondary|Measures of Variability: Mean Absolute Rate of Change|mean absolute rate of change|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||mg/dL per minute||Inter-Quartile Range|Median
1216852|NCT00760526|Secondary|Measures of Variability: Standard Deviation (SD)|standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.|||mg/dL||Inter-Quartile Range|Median
1216853|NCT00760526|Secondary|Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.|26 weeks||||percentage of sensor readings||Inter-Quartile Range|Median
1216854|NCT00760526|Secondary|CGM Glucose Values (mg/dL)|Percentage of sensors values in range (71 mg/dL to 180 mg/dL)|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||percentage of sensor readings||Inter-Quartile Range|Median
1216855|NCT00760526|Secondary|Number of Severe Hypoglycemic Events Experienced by Participants||26 weeks|Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization.|||events|||Number
1216856|NCT00760526|Primary|Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events||26 weeks|Excludes five subjects in the CGM group and four in the control group who dropped out prior to the 26-week visit; for one subject who was missing central laboratory HbA1c values at randomization and one at 26 weeks, the DCA value measured at the site was used to impute values using repeated-measures regression models|||participants|||Number
1216857|NCT00760487|Secondary|IOL Rotation|Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.|6 months post-operative||||Percentage of Participants|||Number
1216858|NCT00760487|Secondary|Spectacle Independence|Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit|6 months post-operative||||Percentage of participants|||Number
1216859|NCT00760487|Primary|Visual Acuity (VA)|Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|Pre-operative, 1 month, 3 month, and 6 month post-operative||||logMAR||Standard Deviation|Mean
1216860|NCT00760474|Secondary|Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria|Participant rated severity of pain upon application of 4 kilograms (kg) pressure via dolorimeter at the bilateral epicondyle tender points (2 tender points, 2 centimeters distal to the epicondyles) described in the American College of Rheumatology (ACR) classification criteria and scored on a 0 (no pain) to 10 (worst possible pain) rating scale. Each arm was to be assessed for any pain (one point on each arm) with the application of pressure.|Day 58|FAS; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
1216861|NCT00760474|Secondary|Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked|"BP cuff evoked allodynia assessed based on participant response to the following question When I take your blood pressure, tell me if the cuff's pressure is painful. A standard BP cuff was inflated at approximately 10 millimeters of mercury (mm Hg) per second up to 180 mm Hg or to point when participant experienced pain; performed 3 times on each arm whether or not pain was reported. If no pain elicited at 180 mm Hg, it was recorded that no sphygmomanometry-evoked allodynia occurred. If pain was reported, value (in mm Hg) at which pain first occured was recorded for each of the assessments."|Day 58|FAS; N=number of participants with analyzable data at observation.|||mm Hg||Standard Deviation|Mean
1216862|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by the participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12). Total (overall) score was sum of items 1 to 15, range 0 to 45; higher scores indicated higher pain/impact. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
1216863|NCT00760474|Other Pre-specified|Pain Catastrophizing Scale (PCS) Including Outliers|"PCS is a participant rated 13-item instrument to measure the presence and severity of catastrophizing. Scored 0 (not at all) to 4 (all the time) to statements such as When I'm in pain…I worry all the time about whether the pain will end. All 13 statements start with When I'm in pain…. Total score ranged from 0 to 52; higher scores reflected greater impairment. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier."|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1216864|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
1216865|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
1216866|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1216867|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1216868|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The individual daily pain score was defined as the final score recorded in the last pain diary of the treatment period 24 hours prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1216869|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 3 day average pain score was defined as the mean daily pain NRS value for the last 3 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1216870|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 7 day average pain score was defined as the mean daily pain NRS value for the last 7 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1216871|NCT00760474|Secondary|Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers|Minimum and maximum pain unpleasantness acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (neutral) to 20 (very intolerable). Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1216872|NCT00760474|Secondary|Gracely Box Scales for Pain Intensity (GBSint) Including Outliers|Minimum and maximum pain intensity acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (no pain sensation) to 20 (extremely intense). Baseline and Post-dose data for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1216873|NCT00760474|Secondary|Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions|Resting state brain activity assessed for correlation of brain seed region (pIns, anIns) to ROI connectivity at baseline (pre-dose) and post-dose (pre minus post) measured using z-score (mean of 0, standard deviation [SD] of 1); range approximately -3 to +3. Positive (+) z-scores reflect greater connectivity (+correlation between seed region and ROI). Negative (-) z-scores reflect -connectivity (anti-correlation between seed region and ROI). ROIs include PCC and IPL from within the default mode network (DMN). DMN is a constellation of regions in which connectivity is augmented in fibromyalgia.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Participants in FAS with quality resting state data (data able to be corrected for motion [head and cardiorespiratory artifacts]).|||z-score||Standard Deviation|Mean
1216874|NCT00760474|Secondary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined ROI brain regions in response to checkerboard visual stimuli (flashing at 8 hertz [Hz]). Reported as percent change between the pre-dose (baseline) and post-dose values.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS.|||percent change in BOLD signal||Standard Deviation|Mean
1216875|NCT00760474|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms [kg] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Change from baseline for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Abbreviation: Dorso Lateral Prefrontal Cortex (DLPFC).|||percent change||Standard Error|Least Squares Mean
1216876|NCT00760474|Primary|Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)|Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Full Analysis Set (FAS) all participants who received a minimum fixed dose of 300 mg/day of study treatment. N=number of participants with analyzable data at observation.|||ratio||Standard Deviation|Mean
1216877|NCT00760461|Primary|Gastroparesis Cardinal Symptom Index||upon study completion|Data cannot be summarized or analyzed due to the lack of data being collected on the primary outcome due to the trial being terminated.||||||
1216878|NCT00760435|Secondary|Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm|left anterior descending coronary artery Z-score; a Z score is the coronary artery adjusted for body surface area|2 weeks||||Z-score||95% Confidence Interval|Mean
1216879|NCT00760435|Secondary|Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm.||24 hours||||mg/dL||95% Confidence Interval|Mean
1216880|NCT00760435|Secondary|Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks)||up to 6 weeks||||days||Inter-Quartile Range|Median
1216881|NCT00760435|Primary|The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion||10 weeks|1 subject in the placebo group was removed from the modified ITT analysis (this subject was removed from the study prior to receiving the placebo)|||participants|||Number
1216882|NCT00760383|Secondary|Mid-thigh Muscle Volume|Analysis was performed using the Analyze 11 software package with semi-automated delineation of quadriceps, hamstrings, and adductors boarders. Using thresholding methods, the software can differentiate operator-delineated parameters set to distinguish muscle from non-muscle (i.e., adipose tissue) using voxel intensity within each border region for quantitative determination of muscle volume.|6 weeks||||Volume (cm^3)||Standard Error|Mean
1216883|NCT00760383|Primary|Quadriceps Muscle Strength||6 weeks||||Newtons||Standard Error|Mean
1216890|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216891|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216892|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216893|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216894|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216895|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216896|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216897|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216898|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216899|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1216900|NCT00760214|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1216901|NCT00760214|Primary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1216902|NCT00760084|Primary|The Number of Subjects With Adverse Events|Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (< 30% blasts) or AML (> 30% blasts).|3 months||||participants|||Number
1216903|NCT00760019|Primary|Flow-mediated, Endothelium-dependent Vasodilation|Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.|Upon completion of 4 weeks of salsalate and placebo treatment|The ultrasound data for two subjects was inadequate for analysis. This determination was made prior to unblinding. The data for these two subjects were discarded, leaving 56 subjects for analysis.|||percentage vasodilation||Inter-Quartile Range|Median
1216904|NCT00760006|Primary|Number of Participants With Fistula or Delayed Wound Healing Following Palatoplasty|Primary outcomes of fistula or delayed wound healing following palatoplasty were measured in two groups of patients. This outcome measure addresses both objectives noted in the summary of the study description.|We anticipate a minimum of less than 2 months to a maximum of 1 year for follow-up will be necessary to document either stage 1 healing or the presence of a palatal fistula in nearly all cases.|"Only participants receiving preoperative antibiotics are considered for this outcome measure. Please refer to the exclusion criteria listed in the initial protocol -- Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or placebo groups."|||Participants|||Count of Participants
1216905|NCT00759967|Secondary|To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Markers of Inflammation||once the final participant has completed all intervention procedures, approx. 3 months||||pg/mL||Inter-Quartile Range|Median
1216906|NCT00759967|Secondary|To Determine Patient Modality Preference.|each participant will complete a questionaire regarding modality preference|at study completion|The trial did not include a questionnaire regarding modality preference as originally planned||||||
1216907|NCT00759967|Secondary|To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Oxidative Stress.||once the final participant has completed all intervention procedures, approx. 3 months||||mmol/ml MDA equivalent||Inter-Quartile Range|Median
1216908|NCT00759967|Secondary|To Determine if Short Daily Hemodialysis, Compared to Conventional Hemodialysis Maintains Metabolic Homeostasis|Serum phosphate values from the end of the three month run in phase and after randomization used to measure metabolic homeostasis|once the last participant has completed run in phase and after randomization, approx. 3 months||||mmol/Litre||Standard Deviation|Mean
1216909|NCT00759967|Secondary|To Determine if the Mechanism by Which Short Daily Hemodialysis is Associated With Changes in Extracellular Fluid Volume|The extracellular fluid volume will be measured using bioelectrical impedance to determine if the mechanism by which short daily hemodialysis is associated with an improvement in blood pressure control is secondary to changes in extracellular fluid volume.|once the final participant has completed all intervention procedures, approx. 3 months||||Litres||Standard Deviation|Mean
1216910|NCT00759967|Primary|Mean Systolic Blood Pressure Over the Third Month of Each Treatment Arm|The average of 2 measurements taken pre each dialysis session in the third month of treatment were compared when the patients were on conventional hemodialysis compared to short daily hemodialysis. SBP was taken in accordance with guidelines from the Canadian Hypertension Society|Average of the last month of the 3 month intervention||||mm Hg||Standard Deviation|Mean
1216911|NCT00759954|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post dose||||ng*hr/mL||Standard Deviation|Mean
1216912|NCT00759954|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng*hr/mL||Standard Deviation|Mean
1216913|NCT00759954|Secondary|Time of Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|Subjects completed the study without protocol violations.|||hour||Full Range|Median
1216914|NCT00759954|Primary|Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
1216915|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months|Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
1216916|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
1216917|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
1216918|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
1216919|NCT00759915|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
1216920|NCT00759915|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
1216921|NCT00759915|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||Hr||Full Range|Median
1216922|NCT00759915|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||ng/mL||Standard Deviation|Mean
1216923|NCT00759902|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
1216924|NCT00759902|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
1216925|NCT00759902|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr||Full Range|Median
1216928|NCT00759863|Secondary|Revised Memory and Behavior Problems Checklist|This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this “bothered or upset” them. A “conditional bother” score is calculated which is the “upset” or “bother” ratings for only the problematic behavior that occurred. Best value = 0. Worst Value = 96.|6 months||||Units on a scale||Standard Deviation|Mean
1216929|NCT00759863|Primary|Multidimensional Observation Scale for Elderly Subject|"This scale reflects the overall well-being of dementia patients. The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: Personal Care, Communication, Awareness & Memory, Mood, and Interpersonal Awareness Behaviors. The overall score provides an indication of the overall perceived well-being of the dementia patient. Best value = 32. Worst Value = 144."|6 months||||Units on a scale||Standard Deviation|Mean
1216930|NCT00759811|Secondary|Incidence of Adverse Effects of the Treatment||12 weeks|||||||
1216931|NCT00759811|Secondary|Incidence of All Cause Mortality, Hospitalization for Worsening Heart Failure, Myocardial Infarct, Stroke or Myocardial Revascularization Need||12 weeks|||||||
1216932|NCT00759811|Secondary|Reduction of Inflammatory Marker Measured Using C-reactive Protein Blood Levels||12 weeks|||||||
1216933|NCT00759811|Secondary|Improve in Quality of Life Measured Using the Brazilian Edition SF-36||12 weeks|||||||
1216934|NCT00759811|Secondary|Improve in Heart Failure Functional Class Measured Using New York Heart Association||12 weeks|||||||
1216935|NCT00759811|Primary|Change in Physical Capacity Measured Using the 6-minute Walk Test Distance|The primary outcome of the study was the difference in 6MWT distance before and after the treatment (change in meters evaluated by t test).|Baseline and 12 weeks||||meters||Standard Deviation|Mean
1216936|NCT00759785|Secondary|Change From Baseline in IGF1R Membrane H-Score After a Single Dose of Dalotuzumab|IGF1R expression was measured in pre and post-dose biopsy samples using an immunohistochemistry assay. Results were expressed as an IGF1R membrane H-score. The H-score was calculated from the percentage of cells staining very weak (+/-); weak (1+); moderate (2+); or strong (3+) and obtained by the formula: (3 x percentage of strongly staining nuclei) + (2 x percentage of moderately staining nuclei) + (1 x percentage of weakly staining nuclei) + (0.5 x percentage of weakly staining nuclei). The H-score ranges from 0 to 300; with a score of 0 representing the absence of IGF1R expression and an H-score of 300 representing maximum IGF1R expression. A decrease in IGF1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement|Baseline and Up to 12 Days|All participants who received a single dose of dalotuzumab, had evaluable baseline and post-dose biopsy samples, and had H-score data available for pre- and post-dose measurements.|||H-score||Full Range|Mean
1216937|NCT00759785|Secondary|Percentage of IGF1R Negative Participants With a Decrease in GFS by Cohort|Biopsy samples were considered IGF1R negative if less than 10% of tumor cells stain. GFS response was correlated with IGF1R expression for ER-positive luminal B and triple negative cohorts.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab, were IGF1R negative at baseline, and had evaluable postdose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
1216938|NCT00759785|Secondary|Percentage of IGF1R Positive Participants With a Decrease in GFS by Cohort|Insulin-like Growth Factor Receptor Type 1 (IGF1R) expression was measured in pre-dose biopsy samples using an immunohistochemistry assay to establish baseline IGF1R positivity. Biopsy samples were considered IGF1R positive if at least 10% of tumor cells stain with intensity 1+ or greater based on staining criteria of very weak (+/-); weak (1+); moderate (2+); or strong (3+). GFS response was correlated with IGF1R expression for ER-positive luminal B and triple negative cohorts.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab, were IGF1R positive at baseline, and had evaluable postdose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
1216939|NCT00759785|Primary|Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)|GFS was measured by microarray analysis of the entire 101 gene signature expression. The GFS is quantified as the change in gene expression between two separate samples collected from the same participant. A log (base 10) ratio of expression in the post-dose sample was generated relative to the reference in both the Up and DOWN arms of the gene signature. A log ratio value of zero indicated no change in the expression between the two samples. GFS was calculated as the mean log ratio of genes in the UP arm minus mean log ratio of genes in the Down arm. GFS was compared for paired samples (pre-dose and post-dose) by a T-statistic calculated as the GFS divided by its standard error. Responders to therapy had a T-statistic that was smaller than the threshold 1st percentile of student's T-distribution and were counted as having a decrease in GFS.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab and had evaluable baseline and post-dose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
1216940|NCT00759772|Primary|Percent Change in Lumbar Spine Bone Mineral Density|Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)|Baseline and 6 months|All participants were included in analysis (intention to treat).|||percentage of change||Standard Error|Mean
1216941|NCT00759759|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
1216942|NCT00759759|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36, 48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
1216943|NCT00759759|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr||Full Range|Median
1216944|NCT00759759|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
1217692|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1216945|NCT00759707|Primary|Change From Baseline in Saphenous Vein Bypass Graft Vasodilation|Flow-mediated, endothelium-dependent vasodilation was determined by comparing baseline vein graft diameter with vein graft diameter as measured after deflation of a 2.5-inch wide sphygmomanometric cuff that had been inflated to suprasystolic pressure for 5 minutes. The cuff was never placed directly over the graft. Vasodilation of the vein graft was determined by acquiring images at 1 minute after cuff deflation.|Single visit study||||vein bypass graft size increase (%)||Standard Error|Mean
1216946|NCT00759681|Primary|Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response|The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.|Treatment through 6 weeks|Based on ITT population for primary safety analysis.|||participants|||Number
1216947|NCT00759681|Primary|Immediate Sealing Evidenced by no Bleeding on Clamp Release.|The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery|Immediate at time of surgery|Treatment sites were the unit of measure based on ITT for effectiveness outcomes.|||Treatment sites|Participants||Number
1216948|NCT00759668|Primary|Near Uncorrected Visual Acuity Right Eye (UCVA RE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1216949|NCT00759668|Primary|Near Best Corrected Visual Acuity Right Eye (BCVA RE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1216950|NCT00759668|Primary|Near Uncorrected Visual Acuity Left Eye (UCVA LE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1216951|NCT00759668|Primary|Near Best Corrected Visual Acuity Left Eye (BCVA LE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1216952|NCT00759668|Primary|Near Uncorrected Visual Acuity (UCVA) Binocular|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1216964|NCT00759577|Primary|Improvement in Patient Perception of Bladder Condition Score (PPBC)|Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.|12 weeks|There was no questionnaire available for analysis. Secondary to poor enrollment the study was stopped and efforts to collect questionnaires at an earlier time point were not carried out.||||||
1216953|NCT00759668|Primary|Near Best Corrected Visual Acuity (BCVA) - Binocular|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1216954|NCT00759655|Secondary|Mean Number of Breakthrough (Spontaneous/Non-traumatic) Bleeds|The number of breakthrough (spontaneous/non-traumatic) bleeds within 48 hours following a prophylaxis dose of Xyntha was summarized. The data from the electronic Infusion Log Diary plus the Test Article CRF was used to determine the number of infusions administered to treat a new bleed, counting only those infusions administered =<48 hours after an infusion marked as 'prophylaxis' (which had no associated bleed).|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Bleeds|Participants|Standard Deviation|Mean
1216955|NCT00759655|Secondary|Response to First On-demand Xyntha Treatment for All New Bleeds as Assessed by the Caregiver|A 4-point response scale to be completed is as defined as follows: (Excellent: definite pain relief/improvement in signs of bleeding starting within 8 hrs after an infusion, with no additional infusion; Good: definite pain relief/improvement in signs of bleeding starting within 8 hrs or following the infusion; Moderate: probable/slight improvement starting after 8 hours following the infusion; No Response: no improvement at all between infusions).|Baseline to 24 months or early withdrawal|The study was terminated, analysis was not conducted.|||Scores on scale|||Number
1216956|NCT00759655|Secondary|Number of Xyntha Infusions Needed to Treat Each New Bleed|The data from the electronic Infusion Log Diary plus the Test Article case report form (CRF) was used to determine the number of infusions administered to treat a bleed. This was calculated by adding the initial ‘for a new bleed’ (on demand) infusion to any subsequent (on demand) infusions for the (same) ‘previously treated bleed’. An on-demand infusion for a ‘previously treated bleed’ was counted toward the bleed with the most recent start time prior to that infusion.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Infusions|Participants||Number
1216957|NCT00759655|Secondary|Mean Annualized Bleed Rate (ABR)|An annualized bleeding rate (ABR) for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the electronic Infusion Log Diary), divided by his total therapy duration (in days), and then multiplied by 365.25.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Number of Bleeds|Participants|Standard Deviation|Mean
1216958|NCT00759655|Primary|Percentage of Participants With Low Recovery LETE|The LETE could be considered lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of participants|||Number
1216959|NCT00759655|Primary|Percentage of Participants With LETE in the Prophylaxis Setting|The LETE in the prophylaxis setting was the occurrence of a bleed. LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (=<48 hours) after a regularly scheduled prophylactic dose of Xyntha (which was not used to treat a bleed) in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of participants|||Number
1216960|NCT00759655|Primary|Percentage of Participants With Less Than Expected Therapeutic Effects (LETE) in the On-Demand Setting|"LETE in the on-demand setting was based on the response to the treatment of a bleeding episode. LETE in the on-demand setting occurred if the participant recorded 2 successive No Response ratings (indicated there was no improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsened) after 2 successive Xyntha infusions, respectively. The infusions was to be administered within 24 hours (=<24 hours) of each other for the treatment of the same bleeding event in the absence of confounding factor."|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of Participants|||Number
1216961|NCT00759655|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of inhibitor development was defined as any result determined positive at a central laboratory (Bethesda inhibitor titer of >=0.6 BU/mL) using Nijmegen modification of the Bethesda assay.|Baseline to 24 months or early withdrawal.|Intent-to-treat (ITT) population: Participants who had received at least 1 dose of Xyntha.|||Percentage of participants|||Number
1216962|NCT00759642|Primary|Progression Free Survival|Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.|12 months||||months||80% Confidence Interval|Median
1216963|NCT00759603|Primary|Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines|Complete response: Absence lymphadenopathy, hepatomegaly or splenomegaly & constitutional symptoms; Normal complete blood count (CBC) exhibited by polymorphonuclear leukocytes>1500/µL, platelets>100,000/µL, hemoglobin>11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate & biopsy normocellular for age with <30% nucleated cells lymphocytes; Absence Lymphoid nodules. Fulfillment CR criteria after induction with exception of treatment related persistent cytopenia & bone marrow lymphoid nodules both considered partial response; Partial response: Requires 50% decrease in peripheral lymphocytes from pre-treatment, 50% reduction in lymphadenopathy, &/or 50% reduction in splenomegaly/hepatomegaly for 2+ months from therapy completion. Additionally one following from pre-treatment: Polymorphonuclear leukocytes 1,500/µL or 50% improvement; Platelets>100,000/µL or 50% improvement; Hemoglobin>11.0 g/dL (untransfused) or 50% improvement.|Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.||||Percentage of Participants|||Number
1223596|NCT00711009|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||mm Hg||Standard Deviation|Mean
1216965|NCT00759564|Secondary|Number of Participants With Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline, 7-10 days after the last dose of study drug|Safety analysis set included all participants who received the study medication.|||participants|||Number
1216966|NCT00759564|Secondary|Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for abnormal ECG (12-lead) values were defined as: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent for baseline value of >200 msec and >=50% for baseline value of <=200 msec for PR interval, QRS interval >=200 msec; QT interval corrected using the Fridericia formula (QTcF) >=500 msec or increase of >45 msec.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
1216967|NCT00759564|Secondary|Number of Participants With Vital Sign Abnormalities|Criteria for vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg, >=20 mmHg maximum increase and decrease from baseline in same posture, heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
1216968|NCT00759564|Secondary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 6/High Power Field [HPF]).|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
1216969|NCT00759564|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
1216970|NCT00759564|Secondary|Concentration Versus Time Summary of Plasma Formate|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1216971|NCT00759564|Secondary|Concentration Versus Time Summary of 2-Ethylbutyric Acid|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1216972|NCT00759564|Secondary|Pharmacokinetics of CP-70429 and PF-03709270 Metabolites|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429 and metabolites.|0.5, 2, 4, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|Data was not collected for this outcome because the metabolite data for CP-70,429 and PF-03709270 were not analyzed as per change in planned analysis||||||
1216973|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1216974|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 1.0 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 1.0 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1216975|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1216976|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 microgram per milliliter (mcg/mL) at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1216977|NCT00759564|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCinf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1216978|NCT00759564|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1216979|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following PF-03709270 Oral Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1216980|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following CP-70,429 Intravenous Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1216981|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following PF-03709270 Oral Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1216982|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70429 Following PF-03709270 Oral Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1216983|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following PF-03709270 Oral Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1216984|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following PF-03709270 Oral Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1217036|NCT00759031|Primary|Gingival Margin Plaque Index|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.|1 day||||Units on a scale||Standard Deviation|Mean
1216985|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following PF-03709270 Oral Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1216986|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following CP-70,429 Intravenous Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||liter per hour (L/hr)||Standard Deviation|Geometric Mean
1216987|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70,429 Following CP-70,429 Intravenous Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1216988|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following CP-70,429 Intravenous Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1216989|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following CP-70,429 Intravenous Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1216990|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following CP-70,429 Intravenous Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1216991|NCT00759525|Primary|Forearm Blood Flow|At the end of each 14-day intervention (Glycyrrhinitic acid or Placebo), vascular endothelial function was assessed by measuring forearm blood flow and comparing to Baseline. The outcome measure depicted below reflects the change in forearm blood flow from Baseline after completing the glycyrrhinitic acid regimen as well as the change in forearm blood flow from Baseline after taking the matching placebo.|Outcome was measured at the end of each study period (i.e. 14 days after Baseline measurements were taken)||||ml/100ml of tissue/min||Standard Error|Mean
1216992|NCT00759473|Primary|Subjective Craving of Cocaine|Average of participants' subjective measures of craving immediately following cue exposure at the one-week follow-up session. Participants rated craving on a 10 point analog scale ranging from 0 (not at all) to 10 (extremely).|two weeks|Data of participants who completed all cue exposure sessions and the one-week follow-up were analyzed.|||units on a scale||Standard Deviation|Mean
1216993|NCT00759408|Secondary|Cardiac Output (CO)|CO will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.|Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)|Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.|||l/min||Standard Error|Mean
1216994|NCT00759408|Secondary|Mean Pulmonary Artery Pressure (PAP)|PAP will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.|Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)|Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.|||mmHg||Standard Error|Mean
1216995|NCT00759408|Secondary|Systemic Vascular Resistance (SVR)|SVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.|Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)|Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.|||dyn*sec/cm^5||Standard Error|Mean
1216996|NCT00759408|Primary|Pulmonary Vascular Resistance (PVR)|PVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.|Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)|Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.|||dyn*sec/cm^5||Standard Error|Mean
1216997|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.|"Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in HAM-A total score.~The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome."|Randomization to week 4||||Participants|||Number
1216998|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.|"Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score.~Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Randomization to week 4||||Participants|||Number
1216999|NCT00759395|Secondary|Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).|"Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome.~Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Week 4||||Units on a scale||Standard Error|Least Squares Mean
1217000|NCT00759395|Primary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score.|The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.|Week 4||||Units on a scale||Standard Error|Least Squares Mean
1217001|NCT00759395|Primary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Week 4||||Units on a scale||Standard Error|Least Squares Mean
1217002|NCT00759356|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
1217003|NCT00759356|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
1217004|NCT00759356|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr||Full Range|Median
1217005|NCT00759356|Primary|Mean Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
1217006|NCT00759330|Secondary|Patient Assessment of Wearability of Therapy|"At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where:~1 = Excellent, 4 = Poor."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||participants|||Number
1217007|NCT00759330|Secondary|Percentage of Patients Who Discontinued|The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.|Days 1 through Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||percentage of patients who discontinued|||Number
1217008|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The total amount (mg) of rescue medication used during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||mg||Standard Error|Least Squares Mean
1217009|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The percentage of patients who used rescue medication during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||percentage of patients|||Number
1217010|NCT00759330|Secondary|Patient Global Impression of Change (PGIC)|"At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where:~1 = very much improved, 7 = very much worse."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||participants|||Number
1217032|NCT00759109|Secondary|Number of Participants With Development of Hepatic Decompensation|The development of hepatic decompensation, defined as worsening of the hepatic function as measured by Child Pugh Score. The Child Pugh score was calculated based on biochemical changes (changes in serum albumin, serum bilirubin, prothrombin time) and clinical impairment (ascites, encephalopathies) or both. Each of the 5 parameters was scored from 1-3, and the Child Pugh Score represented the total score. The maximum score was 15, and a score of 10-15 represents the worst outcome and a life expectancy of 1-3 years.|Baseline, During 3 years of treatment and 2 years of follow-up|ITT population|||Participants|||Number
1217011|NCT00759330|Secondary|Change From Baseline in Total Tender Point Examination Score|"At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where:~0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect."|Baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||units on a scale||Standard Error|Least Squares Mean
1217012|NCT00759330|Secondary|Percent Change From Baseline in Total Functional Rating Index (FRI)|"Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome.~FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where:~Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = ([baseline - Day 7]/baseline)*100.~A positive percent change indicates a favorable treatment effect."|baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||percent change from baseline||Standard Error|Least Squares Mean
1217013|NCT00759330|Secondary|Average Daily Categorical Pain Scale Scores|"Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where:~0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time.~Data are reported as the daily average categorical pain scale score by treatment group."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Deviation|Mean
1217014|NCT00759330|Secondary|Pain Intensity Difference (PID+)|"+PID = pre-treatment value at baseline – post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.~A positive PID indicates a reduction in pain."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Error|Least Squares Mean
1217015|NCT00759330|Primary|Cumulative Summed Pain Intensity Difference (SPID+)|"The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.~Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient."|Days 4 and 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Error|Least Squares Mean
1217016|NCT00759187|Primary|Dental Plaque Index|Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)|4-Day||||Units on a scale||Standard Deviation|Mean
1217017|NCT00759174|Other Pre-specified|Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows.|60-day period prior to onset of NAION symptoms|FAS population. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days or every week within 60 days prior to symptom onset.|||exposed weeks|Participants||Number
1217018|NCT00759174|Other Pre-specified|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|FAS included all participants who signed informed consent, were eligible for study and reported exposure to PDEi within 60 days prior to participant reported-onset of NAION symptoms. N (number of participants analyzed) represents Definite or Possible NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.|||exposed days|Participants||Number
1217033|NCT00759109|Primary|Number of Participants With the Development of Hepatocellular Carcinoma (HCC)|"Participants were tested for focal lesions by liver ultrasound and for AFP levels every 6 months the during study (treatment and follow-up).~The development of hepatocellular carcinoma was determined by:~the appearance of a focal lesion detected by liver ultrasound with metastases confirmed by fine needle biopsy, or~the appearance of a focal lesion detected by ultrasound + alphafetoprotein (AFP) levels in blood >400 ng/mL."|During 3 years of treatment and 2 years of follow-up|ITT population|||Participants|||Number
1217019|NCT00759174|Primary|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|Full Analysis Set (FAS) included all participants who signed informed consent, were eligible for study, reported exposure to PDE5i within 60 days prior to participant-reported onset of NAION symptoms. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.|||exposed days|Participants||Number
1217020|NCT00759161|Secondary|Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 21 and 35 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque vs. vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 7,14, 21, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1217021|NCT00759161|Secondary|Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35|Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1217022|NCT00759161|Secondary|Change From Baseline in Scaling at Day 7,14, 21, 28 and 35|Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1217023|NCT00759161|Secondary|Change From Baseline in Erythema at Day 7,14, 21, 28 and 35|Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1217024|NCT00759161|Secondary|Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1217025|NCT00759161|Primary|Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque versus (vs.) vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 28|ITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1217026|NCT00759148|Secondary|Microbiological Success at the Day 4 (EOT)/Exit Visit|Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.|Day 4|MBITT Analysis Set|||percentage of subjects|||Number
1217027|NCT00759148|Primary|Clinical Cure at the Day 4 (EOT)/Exit Visit|Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.|Day 4|This analysis population includes all patients who received drug, had at least 1 on-therapy visit and were pathogen positive for bacteria on Day 1 (Microbiological Intent-to-Treat (MBITT) Analysis Set).|||percentage of subjects|||Number
1217028|NCT00759109|Other Pre-specified|Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI) at Baseline|Liver tissues obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome.|Baseline|ITT population|||Score on a scale||Standard Deviation|Mean
1217029|NCT00759109|Secondary|Change in the Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI)|"PCNA-LI was measured at baseline and at 18 months of treatment, and the change in PCNA-LI was calculated.~To measure PCNA-LI, liver tissue samples obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome."|Baseline and at 18 months of treatment|Participants with tissue biopsies at 18 months.|||Score on a scale||Standard Deviation|Mean
1217030|NCT00759109|Secondary|Number of Patients With a Virological Response Rate|"Virological Response rate was measured by the disappearance of Hepatitis C Virus from serum. Serum samples from participants were analyzed for the~presence of HCV-RNA using a qualitative polymerase chain reaction (PCR)."|Baseline and every year during 3 years of treatment|ITT population|||Participants|||Number
1217031|NCT00759109|Secondary|Survival Time of Participants|Survival time was defined as time from screening visit to the death of the participant and was studied with Kaplan-Meier and Log-rank tests. If a participant did not die, he or she was censored with the last available date.|During 3 years of treatment and 2 years of follow-up|ITT population|||Years||95% Confidence Interval|Median
1217037|NCT00758862|Primary|Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used|"The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
1217038|NCT00758862|Primary|Area Under the Curve by SIRS Score|"On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s).~The severity was to be recorded using the Severity of Infection Rating Scale (SIRS).~For the SIRS, the following seven clinical signs/symptoms of infection were assessed:~Exudates/pus, Crusting, Erythema, Oedema, Tissue warmth, Itching and Pain.~Each of the seven signs/symptoms was scored using the following scale:~0 = absent 2 = mild 4 = moderate 6 = severe~The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
1217039|NCT00758862|Primary|Area Under the Curve by Baseline Lesion Size|"On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm².~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
1217040|NCT00758862|Primary|Area Under the Curve (AUC(0-t))|"Area under the concentration-time curve (AUC(0-t)) from time 0 to time of last non-zero observation after dosing, calculated by linear/log trapezoidal method.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
1217041|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
1217042|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
1217043|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
1217044|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax )|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
1217045|NCT00758862|Primary|Peak Serum Concentration by Amount of TD1414 Cream Used|"The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
1217046|NCT00758862|Primary|Peak Serum Concentration by SIRS Score|"On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s).~The severity was to be recorded using the Severity of Infection Rating Scale (SIRS).~For the SIRS, the following seven clinical signs/symptoms of infection were assessed:~Exudates/pus Crusting Erythema Oedema Tissue warmth Itching Pain~Each of the seven signs/symptoms was scored using the following scale:~0 = absent 2 = mild 4 = moderate 6 = severe The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
1217047|NCT00758862|Primary|Peak Serum Concentration by Baseline Lesion Size|"On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm². The Cmax is presented by baseline lesion size category (≤15 cm² and >15 cm²).~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
1217048|NCT00758862|Primary|Peak TD1414 Serum Concentration (Cmax )|"The Cmax was summarised by lesion size at baseline, by SIRS scores at baseline and by amount of TD1414 cream used.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses. For description of lesion size, SIRS score and amount of TD1414 cream used please see outcome measure 3, 4 and 5 respectively."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
1217061|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
1217049|NCT00758862|Primary|TD1414 Serum Concentration by Timepoint|On Days 1 and 2(and possibly Day 3 depending on the time of first application on Day 1) a sample was taken for pharmacokinetic(PK) analysis at any time before first application on Day 1, and at 12±1, 18±1, 24±1 and 36±4 hours after first application. If the 36±4 hours sampling time fell on Day 3, then a second sample was also required on Day 3, but was to be obtained at 6pm or afterwards. On Days 3 to 6(and also Day 7 if the very last application fell on Day 8), one sample was taken on each day at any time during the day. On Days 7 and 8(or Days 8 and 9 if very last application was on Day 8), a sample was taken immediately before the very last application and at 6±1, 12±1 and 24±2 hours after the very last application. On Days 9 and 10, one sample was taken on each day at any time during the day. If the participant had already had a sample(s) taken on Day 9 because the timing of some of the post-last application samples fell on this day, then further samples were not required on Day 9|From 0 hours to 240 hours|One participant withdrew at day 3 due to the participant being out of range of the inclusion criterion.|||pg/mL||Standard Deviation|Mean
1217050|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 14 days post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).|||participants|||Number
1217051|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 48 hours post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).|||Participants|||Number
1217052|NCT00758836|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose.|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).|2 hours post-dose|The FAS comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.|||Percentage of Participants|||Number
1217053|NCT00758836|Primary|Percentage of Participants With Pain Freedom at Two Hours Post-dose|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).|2 hours post-dose|The Full Analysis Set (FAS) comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.|||Percentage of Participants|||Number
1217054|NCT00758771|Primary|Shear Rheology|Baseline measure of sputum shear rheology|Cross-sectional||||Pascal||Standard Error|Mean
1217055|NCT00758758|Primary|Neck Disability Index (NDI)|"The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability.~NDI scoring:~0 – 4 = No disability~5 – 14 = Mild disability~15 – 24 = Moderate disability~25 – 34 = Severe disability~35 or over = Complete disability"|12 Months||||units on a scale||Standard Deviation|Mean
1217056|NCT00758758|Primary|Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)|Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months|12 Months||||participants|||Number
1217057|NCT00758745|Primary|Posterior Capsule Opacification (PCO)|Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.|Up to 3 years||||Units on a scale||Standard Deviation|Mean
1217058|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
1217059|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
1217060|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
1223597|NCT00711009|Secondary|Mean Change From Baseline in Urine pH||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||pH||Standard Deviation|Mean
1217062|NCT00758706|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ) Total|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Baseline and Week 6|Full analysis set|||Score on scale||Full Range|Mean
1217063|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||L/min||Full Range|Mean
1217064|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||L/min||Full Range|Mean
1217065|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Flow (FEF) 25−75% at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L/s||Full Range|Mean
1217066|NCT00758706|Secondary|Change From Baseline in Inspiratory Capacity (IC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
1217067|NCT00758706|Secondary|Change From Baseline in Vital Capacity (VC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
1217068|NCT00758706|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
1217069|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
1217070|NCT00758706|Secondary|Incidence of Adverse Events|Number of patients who had an AE|all study visits||||Participants|||Number
1217071|NCT00758706|Primary|Ratio of Total Urine Desmosine at Week 6 to Baseline|Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
1217072|NCT00758706|Primary|Ratio of Sputum Total Cells at Week 6 to Baseline|Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
1217073|NCT00758706|Primary|Ratio of TNF Alpha at Week 6 to Baseline|Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
1217074|NCT00758680|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug|||participants|||Number
1217075|NCT00758680|Secondary|Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)|Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).|Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)|Per-Protocol Population; subset of participants who complied with the protocol sufficiently in terms of considerations as exposure to treatment, availability of measurements and absence of major protocol violations.|||mg/dL||Standard Deviation|Least Squares Mean
1217076|NCT00758680|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug|||participants|||Number
1217077|NCT00758667|Secondary|Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care||one year||||participants|||Number
1217078|NCT00758667|Primary|Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care||one year||||participants|||Number
1217079|NCT00758602|Secondary|Glomerular Filtration Rate (GFR) (mL/Min)|The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
1217080|NCT00758602|Secondary|Serum Creatinine (Micromoles Per Liter [µmol/L])|The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.|||µmol/L||Standard Deviation|Mean
1217082|NCT00758602|Secondary|Percentage of Participants With Treatment Failure at 12 Months Post-Transplant|Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.|Month 12|ITT population|||percentage of participants|||Number
1217083|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant|The median time, in days, between randomization and acute rejection.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population|||days||95% Confidence Interval|Median
1217084|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant - Number of Participants With an Event||BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population|||participants|||Number
1217085|NCT00758602|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant||Months 6 and 12|ITT population|||percentage of participants|||Number
1217086|NCT00758602|Primary|Glomerular Filtration Rate (GFR) at Month 12 After Transplantation|GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].|Month 12|ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.|||mL/min||Standard Deviation|Mean
1217087|NCT00758602|Primary|Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation|CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.|Month 12|ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.|||score on a scale||Standard Deviation|Mean
1217088|NCT00758589|Secondary|Adverse Event (AE)|Number of patients reporting at least one event|4 weeks||||Participants|||Number
1217089|NCT00758589|Secondary|Asthma Control Questionnaire 5 Items (ACQ5)|Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
1217090|NCT00758589|Secondary|Forced Vital Capacity (FVC) at the Clinic|Mean FVC during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
1217091|NCT00758589|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at the Clinic|Mean FEV1 during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
1217092|NCT00758589|Secondary|Reliever Free Day|Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
1217093|NCT00758589|Secondary|Symptom Free Day|Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
1217094|NCT00758589|Secondary|Asthma Control Day|Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
1217095|NCT00758589|Secondary|Awakenings|Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
1217096|NCT00758589|Secondary|Day-time Asthma Symptom Score|Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Standard Deviation|Mean
1217097|NCT00758589|Secondary|Night-time Asthma Symptom Score|Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Standard Deviation|Mean
1217098|NCT00758589|Secondary|Total Use of Reliever|Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Number of inhalations per day||Standard Deviation|Mean
1217099|NCT00758589|Secondary|Evening Forced Expiratory Volume in 1 Second (eFEV1)|Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
1217100|NCT00758589|Secondary|Morning Forced Expiratory Volume in 1 Second (mFEV1)|Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
1217101|NCT00758589|Secondary|Evening Peak Expiratory Flow (ePEF)|Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Standard Deviation|Mean
1217102|NCT00758589|Primary|Morning Peak Expiratory Flow (mPEF)|Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Standard Deviation|Mean
1217103|NCT00758576|Primary|Uncorrected Near Visual Acuity|Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
1217104|NCT00758576|Primary|Uncorrected Distance Visual Acuity|Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
1217105|NCT00758576|Primary|Uncorrected Intermediate Visual Acuity|Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
1217106|NCT00758563|Primary|Mean Gingival Plaque Units|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).|1 day||||Units on a scale||Standard Deviation|Mean
1217107|NCT00758550|Secondary|Questionnaire Results|Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).|6 Months||||Units on a scale||Standard Error|Mean
1217108|NCT00758550|Primary|Uncorrected Visual Acuity (UCVA)|Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 Months after surgery||||logMAR||Standard Deviation|Mean
1217109|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
1217110|NCT00758498|Secondary|Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Percent||Standard Deviation|Mean
1217111|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
1217130|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1217112|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
1217113|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here.|Day 3|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 3|||Units on a scale||Standard Deviation|Mean
1217114|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here.|Day 2|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 2|||Units on a scale||Standard Deviation|Mean
1217115|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here.|Day 1|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 1|||Units on a scale||Standard Deviation|Mean
1217116|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here.|Endpoint defined as either Day 3 or last observation after baseline|Safety analysis population defined as all subjects who had at least one dose of study drug and one State and Trait Anxiety Inventory Assessment after Baseline|||Units on a scale||Standard Deviation|Mean
1217117|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 3|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
1217118|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 2|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
1217119|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 1|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
1217120|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Baseline|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here."|Baseline, prior to start of study drug dosing|Full analysis set defined as all subjects who received at least one dose of study drug and had a baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1217121|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here.|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
1217122|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here.|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
1217123|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here.|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
1217124|NCT00758498|Secondary|Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline|MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here.|Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1||||Minutes||Standard Deviation|Mean
1217125|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here."|Day 3 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1217126|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here."|Day 2 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1217127|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here."|Day 1 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1217128|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here."|Baseline prior to starting study medication|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1217129|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1217141|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Scores on a Scale||Full Range|Mean
1217131|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1217132|NCT00758498|Secondary|Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1217133|NCT00758498|Primary|Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2|"The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1217134|NCT00758498|Primary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2|MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
1217135|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
1217136|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
1217137|NCT00758485|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB), with a higher ratio indicating a greater recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >=0.9, the minimum acceptable ratio that indicated complete recovery from NMB. A shorter time to recovery of the T4/T1 Ratio >=0.9 indicates a faster recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes)|The Intent-to-Treat (ITT) Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
1217138|NCT00758459|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 6 weeks of treatment||||m||Full Range|Mean
1217139|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings|Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Score on scale||Full Range|Mean
1217140|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Scores on a Scale||Full Range|Mean
1217693|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217142|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Score on scale||Full Range|Mean
1217143|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||Score on scale||Full Range|Mean
1217144|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
1217145|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Morning|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
1217146|NCT00758459|Secondary|Forced Expiratory Flow (FEF)25−75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L/s||Full Range|Mean
1217147|NCT00758459|Secondary|Inspiratory Capacity (IC)|Change in IC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
1217148|NCT00758459|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
1217149|NCT00758459|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
1217150|NCT00758459|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in FEV1 from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
1217151|NCT00758459|Primary|Incidence of Adverse Events|Number of patients who had an Adverse Event|all study visits||||Participants|||Number
1217152|NCT00758420|Primary|The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks|The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) - 5] * 4.|Baseline to 8 weeks||||units on a scale||Standard Error|Least Squares Mean
1217153|NCT00758394|Primary|Dental Plaque Index|plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.|4-Day||||Units on a scale||Standard Deviation|Mean
1217154|NCT00758342|Primary|Mean IOP (Intraocular Pressure)||Screening: Week 12; (At 9 am and 4 pm time points)||||mm Hg (millimeters mercury)||Standard Deviation|Mean
1217155|NCT00758290|Primary|Dental Plaque Index|Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque|4 Day||||Units on a scale||Standard Deviation|Mean
1217156|NCT00758264|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1217157|NCT00758264|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1217158|NCT00758264|Secondary|Number of Subjects Reporting Rash|Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1217159|NCT00758264|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1217160|NCT00758264|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Day 0-30) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1217161|NCT00758264|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 4-day (Days 0-3) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.|||Participants|||Count of Participants
1217162|NCT00758264|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|Within the 4-day (Days 0-3) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.|||Participants|||Count of Participants
1217163|NCT00758264|Secondary|Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1217164|NCT00758264|Secondary|Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1217165|NCT00758264|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1217166|NCT00758264|Secondary|Anti-protein D (Anti-PD) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1217167|NCT00758264|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes|Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1217168|NCT00758264|Secondary|Opsonophagocytic Titers Against Pneumococcal Serotypes|Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1217169|NCT00758264|Secondary|Cross-reactive Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1217170|NCT00758264|Secondary|Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1217171|NCT00758264|Primary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Nimenrix Group.|||Titers||95% Confidence Interval|Geometric Mean
1217172|NCT00758264|Primary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Nimenrix Group.|||Participants|||Count of Participants
1217173|NCT00758264|Primary|Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Synflorix Group.|||μg/mL||95% Confidence Interval|Geometric Mean
1217174|NCT00758160|Other Pre-specified|Global Assessment of Satisfaction by Participant|Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217175|NCT00758160|Secondary|Global Assessment of Satisfaction by Parents/Caregivers|Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217176|NCT00758160|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score|CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Participants|||Number
1217177|NCT00758160|Secondary|Clinical Global Impression-Severity (CGI-S) Score|CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217178|NCT00758160|Secondary|Social Adjustment Scale Score for Children and Adolescents (SAICA)|SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children’s current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.|Baseline, Week 4 and Week 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217179|NCT00758160|Secondary|Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score|Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217180|NCT00758160|Secondary|Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score|Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.|Baseline, Week 4 and 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217181|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.|Baseline and Week 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217182|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.|Baseline and Week 4|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217183|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.|Baseline and Week 8|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
1217184|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.|Baseline and Week 4|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
1217185|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.|Baseline and Week 2|Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
1217186|NCT00758069|Secondary|Change From Baseline in Plasma Glucose|Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
1217187|NCT00758069|Primary|Change From Baseline in 24-hour Weighted Mean Plasma Glucose|Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
1217188|NCT00758043|Secondary|Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments||Week 72|||||||
1217189|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively).||Week 24 or Week 48||||participants|||Number
1217190|NCT00758043|Secondary|Proportion of Enrolled Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up||Week 72|||||||
1217191|NCT00758043|Secondary|Proportion of Randomized Subjects Who Relapse, Defined as Those Who Complete Treatment, Have Undetectable HCV RNA at End of Treatment (EOT; Week 24 or Week 48 Respectively), and Become HCV RNA Detectable During Antiviral Follow-up||Week 24 or Week 28|||||||
1217192|NCT00758043|Secondary|Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment|SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.|12 weeks after last dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
1217193|NCT00758043|Secondary|Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).|Week 4 and Week 12|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
1233768|NCT00631488|Secondary|Change From BL to Week 4 in Fasting Plasma Glucose (FPG)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||mg/dL||Standard Error|Least Squares Mean
1217194|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at Week 72|SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.|72 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
1217195|NCT00758043|Primary|Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)|SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).|24 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
1217196|NCT00757848|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217197|NCT00757848|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217198|NCT00757848|Secondary|Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217199|NCT00757848|Secondary|Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217200|NCT00757848|Secondary|Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217201|NCT00757848|Secondary|Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217202|NCT00757848|Secondary|Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217203|NCT00757848|Secondary|Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217204|NCT00757848|Secondary|Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217205|NCT00757848|Primary|Cystic Fibrosis Questionnaire (CFQ-R) - Quittner|Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
1217206|NCT00757848|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Signs and Symptoms|||Number
1217207|NCT00757848|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1217208|NCT00757848|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1217209|NCT00757848|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1217210|NCT00757848|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1217211|NCT00757848|Primary|Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1217212|NCT00757848|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1217213|NCT00757848|Primary|24-hour Sputum Weight|Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||grams||Standard Error|Least Squares Mean
1217214|NCT00757848|Primary|Sputum Percentage Neutrophil Count|Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||percentage of neutrophils in WBCs||Standard Error|Least Squares Mean
1217215|NCT00757848|Primary|Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1217216|NCT00757822|Secondary|Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication|Percent of participants willing to pay extra money for preemptive medication for PONV for subsequent surgical procedures when queried at post-operative 24-48 hr. and at 2-6 wk. follow-up interviews.|Post-operative follow-up interviews 24 hr to 6 weeks post surgery||||percent of participants|||Number
1217217|NCT00757822|Secondary|Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting|Percent of participants who responded that they would be willing to take preemptive medication for nausea and vomiting for subsequent surgeries when queried during post-operative follow-up interviews at 24-48 hrs or 2-6 weeks.|Post operative follow up interviews 24 hrs to 6 wks||||percent of participants|||Number
1217218|NCT00757822|Secondary|Post-operative Antiemetic Use|Percentage of participants requiring post-operative anti-emetic medications.. Anti-emetic medication need was assessed during a) post-operative care unit (PACU) stay and b)during the first 48 hrs. following discharge from PACU to home or if applicable to in-patient unit.|End of surgery to 48 hr post surgery||||percentage of participants|||Number
1217219|NCT00757822|Secondary|Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure|Number of all-cause hospital admissions on day of elective out-patient surgery .|Post-operative Day of Surgery (DOS)||||participants|||Number
1217220|NCT00757822|Secondary|Post-Operative Care Unit Length of Stay (Min)|Length of time in PACU (minutes) measured from end of surgery to time of transfer to ambulatory care prior to home discharge or time to hospital admission if applicable.|Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)||||minutes||Inter-Quartile Range|Median
1217221|NCT00757822|Primary|Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery|Participants were queried for presence of postoperative nausea (PON) or postoperative vomiting (POV) during the 24-48 hr window post surgery.|24-48 hrs post surgery||||percentage of participants|||Number
1217222|NCT00757822|Primary|Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale|"VAS Scale: 0=no nausea, 1-3=mild nausea, 4-6= moderate nausea, 7-9= severe nausea, 10=extreme nausea usually accompanied with vomiting.~VAS nausea score were obtained every 30 min from entry into post-operative care unit (PACU) for first 2 hrs. and then hourly until time of transfer out of PACU."|Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit||||percentage of participants|||Number
1217223|NCT00757822|Primary|Incidence of Postoperative Nausea and Vomiting|The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.|Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)|Per protocol|||percentage of participants|||Number
1217224|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of CD4 cells||Standard Deviation|Mean
1217225|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||cells/uL||Standard Deviation|Mean
1217226|NCT00757783|Secondary|Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.|Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||cells/micro L||Standard Deviation|Mean
1217227|NCT00757783|Secondary|Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.|the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Log10 HIV RNA||Standard Deviation|Mean
1217228|NCT00757783|Secondary|Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)|Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.|||number of participants|||Number
1217229|NCT00757783|Secondary|Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.|Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.|||number of participants|||Number
1217230|NCT00757783|Secondary|Change From Baseline in Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) at Week 12 and 48.|Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.|||HOMA-IR score||Standard Deviation|Mean
1223624|NCT00711009|Secondary|Mean Change From Baseline in Uric Acid (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1217231|NCT00757783|Secondary|Change From Baseline in Insulin at Week 12 and 48.|Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.|||IU/mL||Standard Deviation|Mean
1217232|NCT00757783|Secondary|Change From Baseline in Glucose at Week 12 and 48.|Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.|Baseline, Week 12 and 48|Intent-to-treat (ITT) population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group.|||mg/dL||Standard Deviation|Mean
1217233|NCT00757783|Secondary|Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.|Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ratio||Standard Deviation|Mean
1217234|NCT00757783|Secondary|Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||g/L||Standard Deviation|Mean
1217235|NCT00757783|Secondary|Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||grams per liters (g/L)||Standard Deviation|Mean
1217236|NCT00757783|Secondary|Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
1217237|NCT00757783|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
1217238|NCT00757783|Secondary|Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
1217239|NCT00757783|Primary|Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12|Observed values.|Baseline, Week 12|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||milligram per deciliters (mg/dL)||Standard Deviation|Mean
1217240|NCT00757705|Secondary|Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24|The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217241|NCT00757705|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).|Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.|||Participants|||Number
1217242|NCT00757705|Secondary|Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24|The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.|||Units on a scale||Standard Deviation|Mean
1217243|NCT00757705|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants."|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217244|NCT00757705|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.|||Units on a scale||Standard Deviation|Mean
1217245|NCT00757705|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217246|NCT00757705|Secondary|Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Up to Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.|||Percentage of participants|||Number
1217247|NCT00757705|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217248|NCT00757705|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using last observation carried forward (LOCF). Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1217249|NCT00757666|Secondary|VO2 at Ventilatory Threshold||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1217250|NCT00757666|Secondary|Exercise Time||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1217251|NCT00757666|Secondary|Metabolic Chronotropic Relationship (MCR) Slope||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1217252|NCT00757666|Secondary|Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test|This outcome measure will be compared against baseline.|2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1217253|NCT00757666|Primary|Mean Change in Functional Capacity (Peak VO2).|"The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor.~The mean change in functional capactity will be compared against baseline; changes from baseline will be measured."|1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1217694|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217254|NCT00757627|Secondary|Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4|Weighted scores of the 8 domains of SF36 (i.e., physical functioning; role limiting due to physical problem; bodily pain; general health; vitality; social functioning; role limiting due to emotional problem; mental health) were scored on a scale from 0 ~100, with 100 representing the best possible functioning)|Baseline and Week 4|Intention to treat (ITT)|||Units on a Scale||Standard Deviation|Mean
1217255|NCT00757627|Secondary|Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4||Baseline and Week 4|Only patients with both baseline and week 4 data were included in this analysis.|||Days||Standard Deviation|Mean
1217256|NCT00757627|Secondary|Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4|TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0 (0=worst) to 100 (100=best) were derived from converting the original Likert's scales to VAS scale.|Baseline and Week 4|"22 patients who reported side effects at baseline and week 4 were included in side effect evaluation."|||Units on a Scale||Standard Deviation|Mean
1217257|NCT00757627|Secondary|Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4|BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for pain interference ( 0=no interference to 10= greatest interference).|Baseline and Week 4|Only patients with both baseline and week 4 follow up data were included in this analysis.|||Units on a Scale||Standard Deviation|Mean
1217258|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [ Not present, moderate and extreme]for discomfort and anxiety/depression|Week 4|per protocol|||Percentage of participants|||Number
1217259|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [Not present, moderate and extreme] for discomfort and anxiety/depression.|Baseline|"Only patients with baseline and week 4 data were included in the analysis.~Week 4 N Values; Motility 423 , Self care 422 , Daily Activity 421 , Pain/Discomfort 421 , Anxiety/Depressed 422"|||Percentage of Participants|||Number
1217260|NCT00757627|Primary|"The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 Pain Walking on a Flat Surface at Week 4"|"WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent no pain and 100 represent extreme pain)"|Baseline and end of week 4|"Per protocol (all patients who completed the WOMACpain walking on a flat surface  question at baseline and follow up visit at week 4 will be included for analysis of this endpoint.~Among the 419 patients with follow up visit data, 27 patients rated 0 in their VAS pain score at baseline and were excluded from this analysis."|||Percentage of Participants|||Number
1217261|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants met the criteria of any of the 5 categories at week 4 were collected.|Week 4|Per Protocol|||Percentage of Participants|||Number
1217262|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants who met the criteria of any of the 5 categories at baseline were collected.|Baseline|Only patients with baseline and week 4 data were included.|||Percentage of Participants|||Number
1217263|NCT00757627|Secondary|Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4|The change from baseline in 3 domain scores (pain, stiffness, and difficult in doing daily activity) of WOMAC at week 4 were measured. Each domain comprises of questions and VAS scales for scoring. For pain domain, 0 represents no pain and 100 represents extreme pain; for stiffness domain, 0 represents no stiffness and 100 represents extreme stiffness; for difficult in doing daily activity domain, 0 represents no difficulty and 100 represents most difficulty.|Baseline and Week 4|Only patients with baseline and week 4 data were included in this analysis of change|||Units on a Scale||Standard Deviation|Mean
1217264|NCT00757601|Secondary|Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006|The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM.hr||Standard Deviation|Mean
1217265|NCT00757601|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.|||participants|||Number
1217280|NCT00757588|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response|Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.|||Percentage of participants|||Number
1217266|NCT00757601|Secondary|Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||hr||Standard Deviation|Mean
1217267|NCT00757601|Secondary|Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||hr||Full Range|Median
1217268|NCT00757601|Secondary|Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM||Standard Deviation|Mean
1217269|NCT00757601|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006|The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM.hr||Standard Deviation|Mean
1217270|NCT00757601|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.|||participants|||Number
1217271|NCT00757588|Other Pre-specified|Percentage of Participants With Reported and Confirmed Hypoglycemia|Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/|Baseline to Week 52||||Percentage of Participants|||Number
1217272|NCT00757588|Other Pre-specified|Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period|"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4."|Baseline and during and up to 14 days after last dose of study drug (in Week 52)|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
1217273|NCT00757588|Other Pre-specified|Shift in Platelet Counts From Baseline to Selected Visits (LOCF)|Platelet count=value*10^9 c/L|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
1217274|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Heart Rate||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.|||Beats per minute||95% Confidence Interval|Number
1217275|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.|||mm Hg||95% Confidence Interval|Number
1217276|NCT00757588|Other Pre-specified|Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline to Week 52, continuously|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
1217277|NCT00757588|Other Pre-specified|Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)|Absolute lymphocyte count=value*10^3 c/uL|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
1217278|NCT00757588|Other Pre-specified|Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results|"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions."|Baseline to Week 52|Participants who had normal ECG findings at baseline and who received at least 1 dose of study medication.|||Participants|||Number
1217279|NCT00757588|Secondary|Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)|Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.|||Units||Standard Error|Mean
1217282|NCT00757588|Secondary|Change From Baseline in 120-minute PPG Values During an MTT|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal.|Baseline to Week 24||||mg/dL||Standard Error|Mean
1217283|NCT00757588|Secondary|Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal|Baseline to Week 24||||mg*min/dL||Standard Error|Mean
1217284|NCT00757588|Primary|Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])|Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24- and 52-week periods.|||Percentage of change||Standard Error|Mean
1217285|NCT00757484|Secondary|Surgical Time|Length of surgery|January 2007 to January 2008||||minutes||Full Range|Mean
1217286|NCT00757484|Secondary|Percentage of Participants Undergoing Different Types of Anesthesia|Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control).|January 2007 to January 2008||||percentage of participants|||Number
1217287|NCT00757484|Secondary|Percentage of Women With Asymptomatic Hypotension|% women with asymptomatic hypotension|1 year||||percentage of participants|||Number
1217288|NCT00757484|Primary|Percentage of Participants Who Underwent Gynecologic Surgery|491 women were included in analysis. Measure is categorized by the type of surgery.|January 2007 to January 2008|491 women were included in analysis.|||percentage of participants|||Number
1217289|NCT00757237|Other Pre-specified|Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)|"Antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee.~Use of IV and/or inhaled antibiotics for a respiratory event was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to antibiotic use for a respiratory event was measured in days from baseline (Day 0) to the date of first antibiotic use for a respiratory event or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
1217290|NCT00757237|Other Pre-specified|Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)|Inhaled and/or IV antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antipseudomonal antibiotics was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to IV and/or inhaled antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.|Day 0 through Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||events|||Number
1217291|NCT00757237|Other Pre-specified|Total Number of Respiratory Hospitalizations|Respiratory hospitalizations were determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed hospitalizations and determined which were related to respiratory events.|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||hospitalizations|||Number
1217292|NCT00757237|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20|This 14 item questionnaire consists of 3 subscales that gauge participant perceptions of a medication’s effectiveness, side effects, and convenience. The measure also contains a global satisfaction scale to evaluate overall participant satisfaction. The global satisfaction score is the endpoint reported here. The range of scores is 0 to 100, with higher scores indicating greater satisfaction.|At Week 20|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||units on a scale||Standard Error|Least Squares Mean
1217293|NCT00757237|Other Pre-specified|Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was the average actual change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms) at the end of each treatment course (Weeks 4, 12, and 20).|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The LOCF method was used to impute missing data for statistical purposes.|||units on a scale||Standard Error|Least Squares Mean
1217294|NCT00757237|Other Pre-specified|Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). LOCF method was used to impute missing data for statistical analyses.|||Units on a scale||Standard Error|Least Squares Mean
1223625|NCT00711009|Secondary|Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1217295|NCT00757237|Secondary|Time to First Respiratory Hospitalization|"This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events.~Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF.~Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
1217296|NCT00757237|Secondary|Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events|"IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee.~Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
1217297|NCT00757237|Secondary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of >=84 days in the previous 12 months."|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on participants with prior inhaled tobramycin use >= 84 days in the previous 12 months using the ITT analysis set.|||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
1217298|NCT00757237|Secondary|Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of >= 84 days in the previous 12 months.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on participants with previous inhaled tobramycin use of >= 84 days within the previous 12 months using the ITT analysis set. The last observation carried forward (LOCF) method was used to impute missing data for statistical analyses.|||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
1217299|NCT00757237|Primary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set."|Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
1217300|NCT00757237|Primary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The last observation carried forward (LOCF) method was used to impute missing data.|||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
1217301|NCT00757172|Secondary|Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution|Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.|Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery|All recruited participants.|||participants|||Number
1217302|NCT00757172|Secondary|Percentage of Participants With 2-year Disease-free Survival|Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.|2 years|All registered participants who have met the eligibility criteria.|||percentage of participants|||Number
1217303|NCT00757172|Secondary|Percentage of Participants With 3-year Overall Survival|Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).|3 years|All registered participants who have met the eligibility criteria.|||percentage of participants|||Number
1217304|NCT00757172|Secondary|Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)||Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.|||participants|||Number
1219145|NCT00740714|Secondary|Adverse Experiences: Diarrhoea|Number of participants with diarrhoea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1217305|NCT00757172|Primary|Number of Participants With Pathologic Complete Response Following Surgery|Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.|Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.|||participants|||Number
1217306|NCT00757003|Secondary|Overall Survival|Overall survival is reported as the count of participants alive 60 months following implant procedure.|60 months|9 lost to followup, 4 withdrew, 2 explanted, 1 never implanted, all excluded|||Participants|||Count of Participants
1217307|NCT00757003|Secondary|Count of Participants Experiencing at Least One Endoleak Following Procedure|Endoleak is persistent blood flow in the aneurysm sac.|Up to 60 months following procedure||||Participants|||Count of Participants
1217308|NCT00757003|Primary|Percentage of Participants With Technically Successful Implant|The percentage of participants with technically successful implantation as assessed by the investigator is reported.|Day 0 to Day 30||||percentage of participants|||Number
1217309|NCT00756977|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days||||mOsm/kg||Standard Deviation|Mean
1217310|NCT00756977|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days||||MILL/MCL||Standard Deviation|Mean
1217311|NCT00756977|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
1217312|NCT00756977|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days|Intent to treat population|||1000/MCL||Standard Deviation|Mean
1217313|NCT00756977|Secondary|Serum Chemistry Results (GFR)|Change from Baseline|2 days||||ml/min||Standard Deviation|Mean
1217314|NCT00756977|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||g/dL||Standard Deviation|Mean
1217315|NCT00756977|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||mEq/L||Standard Deviation|Mean
1217316|NCT00756977|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||U/L||Standard Deviation|Mean
1217317|NCT00756977|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population|||standard %||Standard Deviation|Mean
1217318|NCT00756977|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||mg/dL||Standard Deviation|Mean
1217319|NCT00756977|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent"|2-day||||percentage of participants||95% Confidence Interval|Number
1217320|NCT00756964|Primary|Number of Patients With Acute Kidney Injury (AKI).|Acute kidney injury will be defined as an increase in serum creatinine of 0.3mg/dL from baseline or a 50% increase in serum creatinine from baseline values within 48 hours after surgery.|Within 48 hours postoperatively|As no similar study has been performed, a power analysis could not be performed. As such, we decided to do a pilot study with 26 subjects and to set criteria to maximize the likelihood of seeing an effect.|||Participants|||Number
1217321|NCT00756938|Primary|Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.|||Participants|||Number
1217322|NCT00756938|Primary|Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.|||Participants|||Number
1217323|NCT00756938|Secondary|Mean Change From Baseline in Diastolic Blood Pressure|Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation|||mmHg||Standard Deviation|Mean
1217324|NCT00756938|Primary|Mean Change From Baseline in Systolic Blood Pressure|Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation|||mmHg||Standard Deviation|Mean
1217325|NCT00756886|Primary|Atrial Fibrillation||0-21 days post-operative||||participants|||Number
1217326|NCT00756730|Primary|The Change in Fasting Triglyceride Level From Baseline to Week 24||Baseline to week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
1217327|NCT00756730|Primary|At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||percentage of participants|||Number
1217328|NCT00756730|Secondary|HDL Cholesterol at Week 24||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
1217329|NCT00756730|Secondary|LDL Cholesterol at Week 24||week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
1217333|NCT00756730|Primary|Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.|A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.|baseline, 24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia. Neither subject met criteria for virologic failure.|||percentage of patients|||Number
1217334|NCT00756678|Secondary|Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16|Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.|Day 16|Intent to Treat; defined as all randomized (started study) patients.|||Number of patients|||Number
1217335|NCT00756678|Secondary|Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16|"Percentage of patients who responded Strongly Agree and Agree to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are Strongly Agree, Agree, Neither Agree or Disagree, Disagree and Strongly Disagree."|Day 16|Intent to treat; defined as all randomized (started study)patients. Of the 51 randomized patients, data for 50 patients were evaluated for this outcome measure|||Percentage of Patients|||Number
1217336|NCT00756678|Secondary|Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16|Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.|Baseline, Day 16|Intent to Treat; defined as all randomized (started study) patients. Of the 51 randomized patients, data from 49 patients were evaluated for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1217337|NCT00756678|Primary|Mean Frequency of Eye Drop Use Over 1 Week|Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.|1 week|Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure|||Use per day||Standard Deviation|Mean
1217338|NCT00756574|Secondary|Absenteeism|Absent from work because of flu-like illness|over study period||||participants|||Number
1217339|NCT00756574|Secondary|Influenza-like Illness|Cough and fever|Over entire study period||||participants|||Number
1217340|NCT00756574|Secondary|Physician Visits for Respiratory Illness|visit to primary care MD|one year||||participants|||Number
1217341|NCT00756574|Primary|Laboratory-confirmed Influenza Infection|Laboratory confirmed influenza|one year||||participants|||Number
1217342|NCT00756561|Primary|Intratesticular Hormones in Normal Men|Average between right and left testis for each subject and serum hormone concentration in 10 normal men|6-weeks|per protocol|||ng/mL||Inter-Quartile Range|Median
1217343|NCT00756548|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days||||mOsm/kg||Standard Deviation|Mean
1217344|NCT00756548|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days||||million/microliter||Standard Deviation|Mean
1217345|NCT00756548|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days||||1000/MCL||Standard Deviation|Mean
1217346|NCT00756548|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
1217347|NCT00756548|Secondary|Serum Chemistry Results - Glomerular Filtration Rate|Change from Baseline|2 days||||ml/min||Standard Deviation|Mean
1217348|NCT00756548|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
1217349|NCT00756548|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days||||mg/dL||Standard Deviation|Mean
1217350|NCT00756548|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days||||U/L||Standard Deviation|Mean
1217351|NCT00756548|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population|||Percentage of cells||Standard Deviation|Mean
1217352|NCT00756548|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days||||milliequivalent/L||Standard Deviation|Mean
1217353|NCT00756548|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent)"|2 days|186 patients were included in the BLI850 intent-to-treat population. One patient took the preparation but did not undergo colonoscopy due to insurance coverage issues. This patient is excluded from all efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
1217354|NCT00756470|Primary|Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy|Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.|Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)|With an intent-to-treat population analysis, all participants who received any treatment were included in the analyses.|||Percentage of Participants|||Number
1217366|NCT00756314|Primary|Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up|"The acceptability and the use of contraceptives during the follow-up period was defined as just yes or no"|after the contraceptive counseling and during the 6-month follow|"The analysis was by intention to treat in both groups. All the women were retained in their original assigned group."|||participants|Participants||Number
1217695|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217355|NCT00756470|Secondary|Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)|Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.|Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)|While analyses was based on intent-to-treat (ITT) the surgical population includes only subjects who underwent definitive surgery (10 participants had a modified radical mastectomy) thus 5 were not evaluable for this outcome.|||participants|||Number
1217356|NCT00756457|Secondary|Foot Strength|A force transducer (Model SML-200, Interface, Scottsdale, AZ) was connected in series with a resistance plate and oscilloscope (TDS 410A, Tektronix, Beaverton, OR) to display force readings. Participants were seated with their leg in an an air stirrup brace (Aircast, Inc.) mounted on uprights. The air stirrup brace was adjusted so the heel was approximately 10 cm above the resistance plate, resulting in 30 to 45 degrees of ankle plantar flexion depending on foot length. The resistance plate was mounted on ball bearing tracks in the medial/lateral direction and moleskin was used to fit to the general shape of the medial forefoot. The result was that participants could exert maximum effort against the resistance plate (medial direction) with little discomfort. This testing position essentially replicates the manual muscle test position for the posterior tibialis muscle. Force in Newtons was then divided by body mass in kilograms to calculate normalized strength (N/Kg).|Measured at Weeks 1, 6, and 12||||N/kg||Standard Deviation|Mean
1217357|NCT00756457|Primary|Short Musculoskeletal Functional Assessment|The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is a 46 item self-report questionnaire consisting of the Dysfunction Index, which has thirty-four items, and the Bother index which has 12 items. The Dysfunction index is used for assessment of patient perceptions of functional performance while the Bother index is used to assess patients’ perceptions of the degree patients are bothered in broad areas such as recreation and leisure. The responsiveness to change of the SMFA is 10 points out a range of 100 for each scale (Dysfunction, Mobility, and Bother indexes). The SMFA is also particularly suitable for the current investigation due to the presence of a sub-category of questions from the Dysfunction Index that pertains specifically to mobility (i.e. Mobility Index). Lower scores (lowest = 0) indicate better function, mobility, and that patients are less bothered while higher scores (highest = 100) indicate worse function, mobility and that patients are bothered.|Measured at Weeks 1, 6, and 12||||score||Standard Deviation|Mean
1217358|NCT00756457|Secondary|Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)|A 3 dimensional foot kinematic model including the tibia, calcaneus (hindfoot), 1st metatarsal, 2-4th metatarsals and hallux was used to measure foot movement. Six infrared cameras (Optotrak Motion Analysis System, Northern Digital Inc, CAN), synchronized with force plate data (Model 9286, Kistler, Switzerland), were used to collect kinematics (60 Hz) and force (1000 Hz) data with the Motion Monitor software Version 7.24 (Motion Monitor, Innsport Training Inc, USA). Anatomically based coordinate systems were established for each segment using digitized boney landmarks consistent with a previous study. Kinematic data were smoothed using a 4th order, zero phase lag, Butterworth filter with a cut off frequency of 6 Hz. To calculate relative joint angles a Cardan angle Z-X-Y sequence of rotations was used as suggested by Cole et al. The range of possible values varies for each individual and each joint.|Measured at Weeks 1,6 and 12||||Degrees||Standard Deviation|Mean
1217359|NCT00756457|Primary|Foot Function Index(FFI)|The Foot Function Index (FFI) is a validated disease specific questionnaire that has been used to document outcomes in uncontrolled studies of PTTD. The domains of the 23 item FFI questionnaire include pain, disability, and activity limitations. The scale was originally validated in subjects with foot problems related to rheumatoid arthritis patients, and has subsequently been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD. In clinical trials, the FFI has been used to detect change attributable to orthotics, plantar fasciitis, and brace use in PTTD. The three domains of the FFI include pain (FFI-Pain) range 0 to 90, disability (FFI-Disability) range 0- 90, and activity limitations (FFI-Activity Limitations) range 0 to 50. Each category asks patients to rate items relative to pain with higher scores indicating greater pain. The average of the three scales is the FFI-Total.|Measured at Weeks 1, 6, and 12|A power analysis was performed based on previous a previous study. Only the participants that completed the study are included in the analysis. One participant opted to have surgery at 2 weeks from the Brace & Exercise group. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.|||units on a scale||Standard Deviation|Mean
1217360|NCT00756444|Primary|Steady-state Plasma Concentrations (Css) for 5-FU With and Without the Presence of Panitumumab|Steady-state plasma concentrations (Css) of 5-FU were estimated as the mean of two or more evaluable concentrations at 24, 72, and 96 hours after the start of 5-FU infusion. Css is estimated both for subjects receiving 5-FU with panitumumab and for subjects receiving 5-FU without panitumumab|24 to 96 hours following start of cycle 2 infusion with 5-FU|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive Css|||ng/mL||Standard Deviation|Mean
1217361|NCT00756444|Primary|Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab|AUC refers to area under the concentration curve from time 0 to last measurable concentration. AUC of total plasma cisplatin-derived platinum levels is estimated both for subjects receiving cisplatin with panitumumab and for subjects receiving cisplatin without panitumumab.|Levels measured at 0.5, 1, 2, 3, 4, 6 and 24 hours following start of cycle 2 cisplatin infusion|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive AUC|||ng*hr/mL||Standard Deviation|Mean
1217362|NCT00756314|Secondary|Satisfaction With the Used Contraceptive Method|the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.|During the 6-month Follow-up||||participants|||Number
1217367|NCT00756275|Secondary|Beck Depression Inventory|0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression|Week 12|Outcome data available for 80 participants who had valid depression data 12 week assessment.|||units on a scale||Standard Deviation|Mean
1217368|NCT00756275|Secondary|Percent Relapsed to Any Heavy Drinking|6 or more drinks for men; 5 or more drinks for women|6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of particpiants|||Number
1217369|NCT00756275|Secondary|Percent Relapsed to Any Heavy Drinking|6 or more drinks for men; 5 or more drinks for women|3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of participants|||Number
1217370|NCT00756275|Secondary|Percent Relapsed to Drug Use||6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of participants|||Number
1217371|NCT00756275|Secondary|Percent Relapsed to Drug Use||3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of participants|||Number
1217372|NCT00756275|Secondary|Percent Smoking Days||6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of days||Standard Deviation|Mean
1217373|NCT00756275|Secondary|Percent Smoking Days||3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of days||Standard Deviation|Mean
1217374|NCT00756275|Primary|7-day Point-prevalence Smoking Abstinence|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|6 month follow up||||participants|||Number
1217375|NCT00756275|Secondary|Length of Longest Continuous Abstinence||Weeks 9 to 12||||Days||Standard Deviation|Mean
1217376|NCT00756275|Primary|7-day Point-prevalence Smoking Abstinence|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|3 month follow up|"Intent to Treat Note: People who were lost were counted as smoked"|||participants|||Number
1217377|NCT00756236|Primary|Area Under the Curve of etSEV Over the First Hour|We will measure the amount of Sevoflurane used to achieve the same level Bispectral Index. Each patient will have their percentage of sevoflurane in expired breath measured every 5 minutes for 2 hours, resulting in 24 data points per person. The primary endpoint will be area under the curve (AUC) for each subject for the first hour.|Every 5 minutes for 2 hours||||percent*hour||Standard Deviation|Mean
1217378|NCT00756093|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.|once upon instillation||||units on a scale||Standard Deviation|Mean
1217379|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217380|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217381|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217382|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
1217383|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
1217384|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
1217385|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
1217386|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
1217387|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
1217388|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217389|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217390|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217391|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217392|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217393|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217394|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217395|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217396|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217397|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217398|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217399|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217400|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30).|Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217401|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217402|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1217403|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 29-30).|The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
1217404|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 15-16).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
1217405|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 1-2).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
1217406|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217407|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1219146|NCT00740714|Secondary|Adverse Experiences: Nasopharyngitis|Number of participants with nasopharyngitis|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1217408|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217409|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 29 -30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217410|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217411|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217412|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 29-30).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217413|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 15-16).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217414|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 1-2).|All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217415|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217416|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217417|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217418|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217419|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217420|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217421|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217422|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1217423|NCT00756002|Primary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.|Nights 1-2|The Full Analysis Set (FAS) population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and Last Observation Carried Forward (LOCF) data.|||minutes||Standard Error|Least Squares Mean
1217424|NCT00755937|Secondary|Number of Serious Adverse Events||Throughout study (up to 36 months)|Safety data were collected for all patients registered. Total number of subjects: 556. Non serious adverse events: 198. Serious Adverse Events: 105.|||Number of Serious Adverse Events|||Number
1217425|NCT00755937|Primary|Clinical Remission at 36 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1217426|NCT00755937|Primary|Clinical Remission at 24 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1217427|NCT00755937|Primary|Clinical Remission at 12 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1217428|NCT00755937|Primary|Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1217429|NCT00755937|Primary|Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1217430|NCT00755937|Primary|Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1217431|NCT00755911|Secondary|Number of Participants Who Successfully Received Dental Implant Fixtures|The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures|12 months after tooth extraction||||participants|||Number
1217461|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1217432|NCT00755911|Primary|Bone Regeneration|"The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction.~Safety was assessed through adverse event reporting~Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)"|12 months after tooth extraction||||% bone height||Standard Deviation|Mean
1217433|NCT00755846|Secondary|Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).|The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.|85 Days.|"Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline.~Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics."|||percent incidence||Standard Deviation|Mean
1217434|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 85).|The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217435|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 43).|The change between triglycerides collected at day 43 and triglycerides collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217436|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).|The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217437|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).|The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217438|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).|The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217439|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).|The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217440|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 85).|The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217441|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 43).|The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217442|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 85).|The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217443|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 43).|The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217444|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 85).|The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217445|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 43).|The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1217446|NCT00755846|Secondary|Change From Baseline in Glycosylated Hemoglobin at Day 43.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1217447|NCT00755846|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1217448|NCT00755807|Secondary|Change From Baseline in Weight at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||kilograms (kg)||Standard Deviation|Mean
1217449|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||beats per minute (bpm)||Standard Deviation|Mean
1217450|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||mm Hg||Standard Deviation|Mean
1217451|NCT00755807|Other Pre-specified|Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||gram/deciliter (g/dL)||Standard Deviation|Mean
1217452|NCT00755807|Other Pre-specified|Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||milliEq/Liter||Standard Deviation|Mean
1217453|NCT00755807|Other Pre-specified|Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||Thousand/microliter||Standard Deviation|Mean
1217454|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase||Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.|||participants|||Number
1217455|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.|||participants|||Number
1217456|NCT00755807|Secondary|Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)||Baseline (6 weeks) through Endpoint (18 weeks)|All participants randomized to placebo in acute phase received duloxetine during the extension phase.|||participants|||Number
1217457|NCT00755807|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1217458|NCT00755807|Secondary|Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.|Baseline (6 weeks) through Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Error|Least Squares Mean
1217459|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|18 weeks|All randomized participants who entered the extension phase.|||participants|||Number
1217460|NCT00755807|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1217504|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Discomfort|"Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
1217462|NCT00755807|Secondary|Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline (end of acute phase/Week 6), Endpoint (Week 18)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1217463|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).|18 weeks|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1217464|NCT00755807|Secondary|Change From Baseline in Weight at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||kilograms (kg)||Standard Error|Least Squares Mean
1217465|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1217466|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mm Hg||Standard Error|Least Squares Mean
1217467|NCT00755807|Other Pre-specified|Change From Baseline in Uric Acid at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of uric acid.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mg/dL||Standard Deviation|Mean
1217468|NCT00755807|Other Pre-specified|Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mg/dL||Standard Deviation|Mean
1217469|NCT00755807|Other Pre-specified|Change From Baseline in the Platelet Count at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of platelet count.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||Thousand/microliter||Standard Deviation|Mean
1217470|NCT00755807|Other Pre-specified|Change From Baseline in Creatinine at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of creatinine.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1217471|NCT00755807|Other Pre-specified|Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||milliEq/Liter||Standard Deviation|Mean
1217472|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase||Baseline through 6 weeks|All randomized participants.|||participants|||Number
1217473|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline through 6 weeks|All randomized participants.|||participants|||Number
1217474|NCT00755807|Secondary|Number of Participants Who Discontinued During the Acute Phase (by Week 6)||Baseline through 6 weeks|All randomized participants.|||participants|||Number
1217475|NCT00755807|Secondary|Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Deviation|Mean
1217476|NCT00755807|Secondary|Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1217477|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|6 weeks|All randomized participants.|||participants|||Number
1217478|NCT00755807|Secondary|Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1217479|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1217480|NCT00755807|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1217481|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|6 weeks|Number of randomized participants with at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented.|||units on a scale||Standard Error|Least Squares Mean
1217482|NCT00755807|Secondary|Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented for participants with early discontinuation. Baseline-observation-carried-forward (BOCF) imputation was implemented for participants with early discontinuation.|||participants|||Number
1217483|NCT00755807|Primary|Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1217484|NCT00755755|Primary|Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)|Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.|Week 13|Intent-to-treat|||percentage of change||Full Range|Median
1217485|NCT00755755|Primary|Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment."|Week 13 visit|Intent-to-treat|||percentage of patients|||Number
1217486|NCT00755716|Secondary|MNWS|"Minnesota Nicotine Withdrawing Scale~Scale contains 9 items which are scored 0-4. The total range for the scale is 0-36, where higher scores indicate greater nicotine withdrawal symptoms."|Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded.|Subjects only needed to have an MNWS at one of these time points (weeks 7-10) to be included in the analysis.|||units on a scale||Standard Error|Mean
1217487|NCT00755716|Primary|Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment.|The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment.|weeks 7-10||||Participants|||Count of Participants
1217488|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 12 weeks||||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
1217489|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 4 weeks||||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
1217490|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|Form baseline to 12 weeks||||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
1217491|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|From baseline to 4 weeks||||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
1217492|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
1217493|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.|Day 28 post-single dose or Day 21 post-Dose 2|"Four-fold rises in vaccine Influenza titers were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
1217494|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
1217495|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 2|Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group)|||Participants|||Number
1217496|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
1217497|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data."|||Titers||95% Confidence Interval|Geometric Mean
1217498|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Titers||95% Confidence Interval|Geometric Mean
1217499|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.|||Participants|||Number
1217500|NCT00755261|Primary|RECIST|Study was terminated because of low accrual.|6 month PFS|study was terminated because of low accrual (4 subjects enrolled/2 years)||||||
1217501|NCT00755235|Secondary|Treatment Satisfaction|"Single item seven point scale ranging from very satisfied to very dissatisfied"|Measured after 6 months of treatment||||participants|||Number
1217502|NCT00755235|Primary|20-Item Symptom Checklist Depression Scale|20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.|Measured at baseline and after 6 months of treatment|Analysis included all participants participating in outcome assessment|||units on a scale||Standard Deviation|Mean
1217503|NCT00755222|Primary|Change From Baseline in PDQ Penile Pain|Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
1219147|NCT00740714|Secondary|Adverse Experiences: Tremor|Number of participants with tremor|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1217505|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Contraint|"Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
1217506|NCT00755222|Primary|Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie’s Disease Symptom Bother|"Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
1217507|NCT00755222|Primary|Change From Baseline in Penile Curvature|Negative change reflects improvement in penile curvature|Baseline and Week 36 or last observation carried forward (LOCF)||||Percent change from baseline||Standard Deviation|Mean
1217508|NCT00755196|Secondary|Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque vs. vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 7, 14, 28, 42, 56, 70, 91|ITT population included all randomized participants who received the study medication.|||percentage of participants|||Number
1217509|NCT00755196|Primary|Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque versus (vs.) vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 84|ITT population included all randomized participants who received the study medication.|||percentage of participants|||Number
1217510|NCT00755131|Other Pre-specified|Heart Rate Recovery at Baseline and 6 Months|"The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system.~Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease."|baseline and 6 month follow-up||||beats/min||Standard Deviation|Mean
1217511|NCT00755131|Secondary|Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months|Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute.|Baseline and 6-month follow-up|intention to treat (ITT) analysis|||ml/kg/min||Standard Deviation|Mean
1217512|NCT00755131|Primary|High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months|High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response.|baseline and 6-month follow-up||||ng/ml||Standard Deviation|Mean
1217513|NCT00755105|Primary|Rate of Iron Excretion.|Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55|4 years|Per protocol|||milligrams per day||95% Confidence Interval|Mean
1217514|NCT00755079|Secondary|Expiratory Respiratory Muscle Strength|Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.||||cmH2O||Standard Deviation|Mean
1217515|NCT00755079|Primary|Inspiratory Respiratory Muscle Strength|Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.||||cmH2O||Standard Deviation|Mean
1217516|NCT00755040|Secondary|Numerical Score of Ocular Surface Disease Index (OSDI) and Development or Lack of Ocular GVHD (by Ophthalmologic Examination) as Measured by Odds Ratio in a Linear Regression Model.|OSDI is a patient reported questionnaire consisting of 12 questions which are scored from 0 to 4. The total scored is computed and depending on the number of questions answered scores are computed which are then categorized into mild, moderate or severe dry eye symptoms. This tool should adequately reflect the morbidity of the dry eye symptoms.|1 year after transplant|Not collected/analysed due to staffing constraints||||||
1217517|NCT00755040|Primary|Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)|Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were <5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.|Up to 2 years after transplantation|Number of patients that develop ocular GVHD while on study|||participants|||Number
1217518|NCT00754923|Secondary|Mutational Status for EGFR or Kras||2008-present||||participants|||Number
1217519|NCT00754923|Secondary|Toxicity||2008-present|||||||
1217520|NCT00754923|Secondary|Overall Survival||2008-present|||||||
1217521|NCT00754923|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate"|6 months||||participants|||Number
1217522|NCT00754845|Secondary|Change From Baseline in Role Function- Physical Scale on SF(Short Form)-36 Health Survey|Difference between post baseline scores and baseline score of role function-physical scale on SF-36 Health Survey (scale range between 0 and 100 with higher score indicating better quality of life).|8 years|All randomized patients.|||score on a scale||Standard Error|Least Squares Mean
1217523|NCT00754845|Secondary|Overall Survival (OS)|For subjects who died, overall survival was calculated in months from the day of randomization to the date of death. Otherwise, survival was censored at the last day the patient was known to be alive. Probability of overall survival at 5 years is estimated and reported.|Until the end of study with a median follow-up of 75 months|All women randomized|||probability of OS at 5 years||95% Confidence Interval|Number
1217524|NCT00754845|Secondary|Incidence of Contralateral Breast Cancer|The annual incidence rate was estimated based on the time to the development of contralateral breast cancer, which was calculated in months from the day of randomization to the diagnosis date of contralateral breast cancer for subjects who had developed the contralateral breast cancer, to the time of death for the patient who died, or to the last day the patient was known alive for subjects without contralateral breast cancer|10 years|All women randomized|||Number of new case per 1000 person years||95% Confidence Interval|Number
1217525|NCT00754845|Primary|Disease-free Survival (DFS)|It is defined as the months from the day of randomization to the earliest date when a recurrence of the primary disease (recurrence in the breast, chest wall and nodal sites or the development of metastatic disease) or a contralateral breast cancer was observed. Subjects who died without recurrence of the primary disease or the development of the contralateral breast cancer were censored at their death date. If a patient has not recurred, developed a contralateral breast cancer, or died, disease-free survival was censored on the date of the last day the patient was known to be alive. Probability of disease free survival at 5 years is estimated and reported.|Unitil the end of study with a median follow up of 75 months|All women randomized were included in the analysis based on treatment arm they were randomized.|||probability of DFS at 5 years||95% Confidence Interval|Number
1217526|NCT00754832|Secondary|Realtime Digital Fatigue Score|fatigue scored on 0-10 scale with higher scores indicating more fatigue|6 weeks of intervention||||units on a scale||Standard Deviation|Mean
1217527|NCT00754832|Secondary|Modified Fatigue Impact Scale|21 item scale, score range 0-84, lower scores indicate less fatigue|6 weeks of intervention||||units on a scale||Standard Deviation|Mean
1217528|NCT00754832|Primary|Fatigue Severity Scale|The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.|after 6 weeks of intervention|intention to treat|||units on a scale||Standard Deviation|Mean
1217529|NCT00754793|Primary|Sino-Nasal Outcome Test-20 (SNOT-20)||baseline, 1 month, 3 months|||||||
1217530|NCT00754767|Primary|Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork|Data was not analyzed due to study termination|baseline, days 1 and 2 post chemo x 4 cycles|||||||
1217531|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 36 months post randomization||||participants|||Number
1217532|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1217533|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1217534|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1217535|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1217536|NCT00754741|Secondary|LDL Cholesterol Levels||at 12 months post randomization||||mg/dL||Standard Deviation|Mean
1217537|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 12 months post randomization||||Percent||Standard Deviation|Mean
1217538|NCT00754741|Secondary|LDL Cholesterol Levels||at 6 months post randomization||||mg/dL||Standard Deviation|Mean
1217539|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 6 months post randomization||||Percent||Standard Deviation|Mean
1217540|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 24 months post randomization||||participants|||Number
1217696|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217541|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1217542|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1217543|NCT00754741|Primary|LDL-cholesterol Levels||at 18 months post randomization||||mg/dL||Standard Deviation|Mean
1217544|NCT00754741|Primary|Glycated Hemoglobin Levels||at 18 months post randomization||||Percent||Standard Deviation|Mean
1217545|NCT00754650|Secondary|Best Overall Response (BOR)|The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.|||Percentage of participants|||Number
1217546|NCT00754650|Primary|Bone Marrow Response|Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.|||Percentage of infiltration||Inter-Quartile Range|Median
1217547|NCT00754624|Secondary|High Resolution Computerized Tomography Scans of the Chest||End of study|participants in Safety population with available post-baseline data|||participants|||Number
1217548|NCT00754624|Secondary|Change in Weight in kg From Baseline to End of Study|Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months)|Safety|||kilograms||Standard Deviation|Mean
1217549|NCT00754624|Secondary|Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)|Change from Baseline to last study measurement on treatment (maximum of 48 months)|Baseline to last study measurement on treatment (maximum of 48 months)||||milligrams per deciliter||Standard Deviation|Mean
1217550|NCT00754624|Secondary|Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)|Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months|Safety|||percentage||Standard Deviation|Mean
1217551|NCT00754624|Secondary|Annual Rate of Change in DLCo From Baseline to End of Study||Baseline to 48 months|Safety|||mL/min/mmHg per year||Standard Error|Mean
1217552|NCT00754624|Secondary|Annual Rate of Change in FVC From Baseline to End of Study||Baseline to 48 months|Safety|||Liters per year||Standard Error|Mean
1217553|NCT00754624|Primary|Annual Rate of Change in FEV1 From Baseline to End of Study||Baseline to 48 months|Safety Population defined as all subjects who received at least one dose of study drug|||Liters per year||Standard Error|Mean
1217554|NCT00754572|Secondary|Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
1217555|NCT00754572|Secondary|Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
1217556|NCT00754572|Secondary|Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity and DAS28<2.6 = remission|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1217557|NCT00754572|Secondary|Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population. All participants with endpoint values collected at Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
1217971|NCT00752726|Secondary|Change From Baseline to Week 24 in Liver Fat|The liver fat was measured by CT scan in Hounsfield Units (HU).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Hounsfield Units (HU)||Standard Deviation|Mean
1217558|NCT00754572|Secondary|AUC of DAS28|The AUC was computed using the trapezoidal rule, considering baseline value as 0, through NCSS software. For each participant, AUC for DAS28 units was calculated. Each individual AUC DAS28 value was divided by 52 to have the conversion of AUC DAS28 in unit weeks to AUC DAS28 in unit years, as 1 week is approximately 1/52 years. The set of individual AUC DAS28 was computed as summary statistics.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||scores on a scale * years||Standard Deviation|Mean
1217559|NCT00754572|Secondary|Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24|DAS28- based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with DAS28 < 3.2; moderate response: change from baseline >1.2 with DAS28 >3.2 to <5.1 or change from baseline >0.6 to <1.2 with DAS28 <5.1; No response: change from baseline < 0.6 or change from baseline >0.6 and <1.2 with DAS28 >5.1.|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1217560|NCT00754572|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24|DAS28 calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
1217561|NCT00754572|Secondary|Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models|The probability of ACR positive response was determined using the GEE.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||odds||95% Confidence Interval|Number
1217562|NCT00754572|Secondary|Percentage of Participants Achieving ACR20 Response|"ACR20 is defined as 20% improvement in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain (VAS)~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by the HAQ-DI~Acute phase reactant levels - ESR or CRP"|Week 2|ITT Population; All participants with endpoint values collected at Week 2 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1217563|NCT00754572|Secondary|Area Under The Curve (AUC) of the ACR(n)|ACR-n was defined as the lowest of 3 values (the percent change in the swollen joint count, the percent change in the tender joint count, and the median of the other 5 measures in the ACR core data set which included Participant's global assessment of pain (VAS), Participant's global assessment of disease activity (VAS), Investigator/Physician's global assessment of disease activity (VAS), Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP). Therefore, a percentage value was assigned to each participant at each timepoint. AUC was calculated for each participant from baseline to Week 112. Mean and standard deviation values are are provided in percent*years.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||percent*years||Standard Deviation|Mean
1217564|NCT00754572|Secondary|Percent Change From Baseline in HAQ-DI at Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1217565|NCT00754572|Secondary|HAQ-DI at Baseline and Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 =without difficulties; 1= with some difficulties; 2=with great difficulties; and 3= unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified time point.|||units on a scale||Standard Deviation|Mean
1217566|NCT00754572|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1217578|NCT00754559|Secondary|Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response|Participants who withdrew from study drug due to other reasons were not taken into account.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; participants who withdrew from study drug due to other reaasons were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1217579|NCT00754559|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammation marker used to determine acute phase response.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.|||mm/h||Standard Deviation|Mean
1217567|NCT00754572|Secondary|Physician's Global Assessment of Disease Activity at Baseline and Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
1217568|NCT00754572|Secondary|Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1217569|NCT00754572|Secondary|Participant's Global Assessment of Disease Activity at Baseline and Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n= number of participants analyzed for the given parameter at the specified time point.|||mm||Standard Deviation|Mean
1217570|NCT00754572|Secondary|Percent Change From Baseline in Pain as Assessed by the Participant at Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at Baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1217571|NCT00754572|Secondary|Pain as Assessed by the Participant at Baseline and Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at the specified timepoints were included in the analysis. number (n) equals (=) number of participants analyzed for the given parameter at the specified time point.|||mm||Standard Deviation|Mean
1217572|NCT00754572|Secondary|Percent Change From Baseline in SJC and TJC at Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1217573|NCT00754572|Secondary|SJC and TJC at Baseline and Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||joints||Standard Deviation|Mean
1217574|NCT00754572|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
1217575|NCT00754572|Secondary|Time to Onset of ACR20, ACR50, and ACR70|"ACR20, ACR50 and ACR70 are defined as 20, 50 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain by VAS~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by HAQ-DI~Acute phase reactant (ESR or CRP)"|Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
1217576|NCT00754572|Secondary|Percentage of Participants With ACR20 and ACR70 Response at Week 24|"ACR20 and ACR70 are defined as 20 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain by VAS~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by HAQ-DI~Acute phase reactant (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1217577|NCT00754572|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"ACR50 is defined as 50 percent (%) improvement in: a) Swollen Joints Count (SJC) and Tender Joints Count (TJC) and b) Three of the following 5 assessments:~Participant's global assessment of pain by Visual Analog Scale (VAS)~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)~Acute phase reactant levels - Erythrocyte Sedimentation Rate or C-Reactive Protein (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1217582|NCT00754559|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Score|The TSQM is a general measure of participants treatment satisfaction and consists of 14 questions that result in 4 subscales: “effectiveness”, “side-effects”, “convenience” and “global satisfaction”. All subscale scores range from 0 to 100%, with 100% being the best possible result.|Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1217583|NCT00754559|Secondary|Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF|Participants were asked to assess their overall level of fatigue/tiredness during the previous 24 hours using a 100-mm horizontal VAS with 0=none and 100=very severe. Participants responded by placing a mark on the line to indicate their current level of fatigue. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2 and 4|ITT Population; Missing data were imputed using LOCF.|||mm||Standard Deviation|Mean
1217584|NCT00754559|Secondary|Duration of Morning Stiffness as Assessed Using PTHF|Duration of morning stiffness: participants were asked 'how long did your morning stiffness last from the time you woke up yesterday' and the response was provided in minutes and hours. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline, Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.|||hours||Standard Deviation|Mean
1217585|NCT00754559|Secondary|Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)|Participant's were asked to state the worst level of pain felt in the past 24 hours using a 100-mm horizontal VAS (0 to 100 mm) with 0=no pain and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their level of pain. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.|||mm||Standard Deviation|Mean
1217586|NCT00754559|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Absolute change was defined as the change from baseline to Week 24.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1217587|NCT00754559|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1217588|NCT00754559|Secondary|Change From Baseline in HAQ-DI at Week 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1217589|NCT00754559|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|"CDAI was calculated according to the following formula:~CDAI = Number of swollen joints (plus) + Number of tender joints + VAS disease activity participant assessment + VAS disease activity investigator assessment. The maximum score was 334 (66 joints + 68 joints + 100 mm + 100 mm); higher scores indicated higher disease activity."|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population; only participants with values for CDAI at baseline and the respective visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
1217590|NCT00754559|Secondary|Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24|"Participant’s global assessment of disease activity was an overall assessment of their current disease activity on a 100-mm horizontal VAS scale (left-hand extreme: “no disease activity”; right-hand extreme: “maximum disease activity”).~Physician’s global assessment of disease activity was measured as participant’s current disease activity on a 100-mm horizontal VAS scale (left hand extreme: “no disease activity”; right-hand extreme: “maximum disease activity”)."|Week 24|ITT Population; missing data were imputed using LOCF.|||mm||95% Confidence Interval|Mean
1217591|NCT00754559|Secondary|Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24|Participant's global assessment of pain was assessed using a 100-mm horizontal VAS (0 to 100 mm) with 0=pain absent and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Week 24|ITT Population; missing data were imputed using LOCF.|||mm||95% Confidence Interval|Mean
1217592|NCT00754559|Secondary|Change From Baseline in the Levels of C-Reactive Protein at Week 24|The serum concentration of CRP is measured in mg/L. A reduction in the level was considered an improvement.|Week 24|ITT Population; missing data were imputed using LOCF.|||mg/L||95% Confidence Interval|Mean
1217593|NCT00754559|Secondary|Change From Baseline in Swollen and Tender Joint Counts at Week 24|"Swollen joint count: 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.~Tender joint counts: 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68."|Week 24|ITT Population; missing data were imputed using last observation carried forward (LOCF).|||Joints||95% Confidence Interval|Mean
1217652|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with an AUC(0-24hr) measurement|||nmol*hr/L||Standard Deviation|Mean
1217594|NCT00754559|Secondary|Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response|ACR20/50/70 response: ≥20%, 50%, or 70% improvement, respectively, in swollen and tender joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
1217595|NCT00754559|Secondary|Percentage of Participants With a DAS28 Response at Weeks 4 and 24|DAS28 calculated from the number of swollen joints and painful joints using the 28-joint count, the ESR and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment using VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 = low disease activity, DAS28 <2.6 = remission and a clinically significant (CS) reduction was defined as ≥1.2.|Weeks 4 and 24|ITT Population;|||percentage of participants||95% Confidence Interval|Number
1217596|NCT00754559|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population|||Percentage of Participants|||Number
1217597|NCT00754559|Secondary|Absolute Changes in DAS28 From Baseline|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant rated global assessment of disease activity using 100-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; only participants with a DAS28 value at baseline were included in the analysis.|||units on a scale||Standard Deviation|Mean
1217598|NCT00754559|Primary|Percentage of Participants With Low Disease Activity Score at Week 24|Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Week 24|ITT population.|||Percentage of Participants||95% Confidence Interval|Number
1217599|NCT00754546|Secondary|Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise|"linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise~The higher the number the worse the shortness of breath"|After one dose||||breathlessness units/min||Standard Deviation|Least Squares Mean
1217600|NCT00754546|Primary|Exercise Endurance Time|Participants were asked to exercise until symptom limitation|After one dose|Number of participants determined by previous studies. Analysis was intention to treat|||seconds||Standard Deviation|Mean
1217601|NCT00754494|Secondary|Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks||||participants|||Number
1217602|NCT00754494|Secondary|Number of Participants Reported at Least 1 Rash Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks||||participants|||Number
1217603|NCT00754494|Secondary|Number of Participants Reported at Least 1 Side Effect During the Study|Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.|Up to 9 weeks||||participants|||Number
1217604|NCT00754494|Secondary|Normal Mucosa OSI-420 Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mg||Standard Deviation|Mean
1217605|NCT00754494|Secondary|Normal Mucosa Erlotinib Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mg||Standard Deviation|Mean
1217606|NCT00754494|Secondary|Plasma OSI-420 Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mL||Standard Deviation|Mean
1217607|NCT00754494|Secondary|Plasma Erlotinib Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mL||Standard Deviation|Mean
1217608|NCT00754494|Secondary|ACF: Normal Mucosa pERK Ratio|Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.|Up to day 30|ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels||||||
1217609|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in ACF|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
1218198|NCT00750191|Primary|Physical Function|"Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component.~Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome)."|6 months||||units on a scale||Standard Deviation|Mean
1217610|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in ACF|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
1217611|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in Normal Mucosa|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
1217612|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in Normal Mucosa|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
1217613|NCT00754494|Primary|Change in ACF pERK Levels|Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.|From baseline to post-treatment (up to 30 days)|Change in ACF pERK levels not reported as the assay did not demonstrate signaling||||||
1217614|NCT00754468|Secondary|Side Effects of Subjects Receiving Cryospray Therapy.||End of Study||||side effects|||Number
1217615|NCT00754468|Primary|Depth of Injury|histopathological findings analyzed to determine max depth of injury (mm)|End of Study||||millimeters|Participants|80% Confidence Interval|Mean
1217616|NCT00754442|Secondary|The Number of Patients With Mutations in CYP27B1|CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data|blood samples taken at baseline and sequenced over several days|All patients were sequenced and compared to published control data. Controls were not sequenced for cost reasons|||participants|||Number
1217617|NCT00754442|Primary|The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours|1,25-D was measured at baseline, 4 and 8 hours after PTH infusion|baseline, 4 and 8 hours after start of infusion|The final analysis was made on participants with glomerular filtration rate (GFR) of 70 and above since <70, 1,25-D production decreases. After study completion, it was noted that one participant in each group (patient and control) had GFR<70 so these two participants were excluded from final analysis.|||pg/ml||Standard Deviation|Mean
1217618|NCT00754390|Primary|Zinc Absorption|Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time|16 weeks|Analysis restricted to women who completed all 4 treatment periods|||Percentage of Zinc-65 absorbed||Standard Error|Mean
1217619|NCT00754377|Secondary|Change in Knowledge Scores About Quality Improvement|Residents' knowledge was assessed using the knowledge scale (e.g., describe change concept, how a cause-effect diagram is created, elements of the improvement model) from the SQI TAT and scores could range from 0 to 54 points. Difference scores were used based on total score of the scale with larger positive values indicating more increase in knowledge.|1 Month||||units on a scale||Standard Deviation|Mean
1217620|NCT00754377|Primary|Beliefs About Ability to Implement a CQI Project|Residents' belief about their ability to implement a CQI project was measured using a single efficacy item (values ranged from 1, strongly disagree, to 5, strongly agree). The item is from the Systems Quality Improvement Training and Assessment Tool. Differences (post minus pre) in this belief item were looked at with positive and higher difference values reflecting more positive change/increase in belief.|1 month||||units on a scale||Standard Deviation|Mean
1217621|NCT00754338|Primary|Lens Deposits|Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1217622|NCT00754338|Primary|Lens Wettability|Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1217623|NCT00754338|Secondary|Corneal Staining|"Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.~Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.~A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining."|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1217624|NCT00754338|Secondary|Subjective Vision|Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1217625|NCT00754338|Secondary|Dryness|Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.|4 weeks|analysis was per protocol|||Units on a Scale||Standard Deviation|Mean
1218258|NCT00749606|Primary|Weight|Weight (kg)|baseline, 1, 2, 3 years||||kg||Standard Deviation|Mean
1217627|NCT00754325|Secondary|Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Safety Population on initial treatment; any participants that was randomized to any treatment group in the study and received at least one treatment therapy.|||participants|||Number
1217628|NCT00754325|Secondary|Number of Participants With Best Overall Response|Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval. An unconfirmed CR was recorded as PR.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment with measurable lesion by RECIST (Response Evaluation Criteria In Solid Tumors). Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||participants|||Number
1217629|NCT00754325|Secondary|Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)|Table represents the best response achieved over this time frame. CR = Disappearance of all target lesions. No new lesions. PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||participants|||Number
1217630|NCT00754325|Secondary|Percentage of Participants With Clinical Benefit for At Least 6 Months|Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination, radiological assessment, and bone scans (if applicable) were used to assess outcome.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||percentage of participants||95% Confidence Interval|Number
1217631|NCT00754325|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan Meier assessments were used to estimate the percentages.|at 6 months|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||percentage of participants||95% Confidence Interval|Number
1217632|NCT00754325|Secondary|Median Time of Progression-free Survival (PFS)|Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||months||95% Confidence Interval|Median
1217653|NCT00754130|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.~Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.|||participants|||Number
1217697|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217633|NCT00754325|Primary|Number of Participants With Disease Progression (PD) or Death|This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included as non-responders. Censored participants = 15 Fulvestrant and Dasatinib, 9 Fulvestrant|||participants|||Number
1217634|NCT00754234|Primary|Nonheme Iron Absorption|Absorption was estimated from whole body retention of a Iron-59 radiotracer, 2 weeks after consuming a menu labeled with the isotope, then normalized to a ferritin of 15 nanogram/milliLiter (ng/mL)|2 weeks (wks)|Analysis was per protocol|||percentage of nonheme Iron absorbed||Standard Deviation|Log Mean
1217635|NCT00754208|Secondary|Clinical Global Impression- Improvement|The Clinical Global Impression-Improvement scale is a measure of the clinician's assessment of the overall degree of improvement in ADHD symptoms from baseline to endpoint. The CGI-I is rated on a 1 to 6 scale, with 1=very much improved, 2=much improved, 3=minimally improved, 4= no change, 5= minimally worse, 6=much worse.|8 weeks||||Participants|||Count of Participants
1217636|NCT00754208|Secondary|Change in Children's Global Assessment Scale (CGAS) Score|This measures the change in the subject's global assessment of functioning as rated by the clinician. This Children's Global Assessment Scale (CGAS) is rated on a 0-100 scale (refer to baseline information). The change in this score is the difference between the score at baseline to end point.|8 weeks||||units on a scale||Standard Deviation|Mean
1217637|NCT00754208|Secondary|Change in Clinical Global Impression-Severity|Change in global rating of severity of ADHD symptoms. CGI severity is rated on a scale of 1 to 6 (normal to severely ill; refer to description in baseline information). The change in the severity rating reflects the change in this score from baseline to endpoint.|8 weeks||||units on a scale||Standard Deviation|Mean
1217638|NCT00754208|Primary|Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score.|Change from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline.|8 weeks||||units on a scale||Standard Deviation|Mean
1217639|NCT00754156|Secondary|Blood Transfused||Duration of Hospital Stay less than 6 months||||Units||Inter-Quartile Range|Median
1217640|NCT00754156|Secondary|Hospital Days||Duration of Hospital Stay less than 6 months||||Days||Inter-Quartile Range|Median
1217641|NCT00754156|Secondary|ICU Days||Duration of hospital stay less than 6 months||||Days||Inter-Quartile Range|Median
1217642|NCT00754156|Secondary|Days to Closure||Duration of Hospital Stay less than 6 months||||Days||Inter-Quartile Range|Median
1217643|NCT00754156|Primary|Operating Room Time Utilization|The amount of time needed to manage the open abdomen inside the operating room.|Duration of Hospital Stay less than 6 months||||Minutes||Standard Deviation|Mean
1217644|NCT00754156|Primary|Number of Trips to the Operating Room||12 Months||||Number of trips||Inter-Quartile Range|Median
1217645|NCT00754156|Primary|Primary Closure Rate|The rate in which the abdomen was closed the first time.|up to 12 months|Descriptive Study.|||% of participants|||Number
1217646|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr|Geometric Mean of the Day 5 to Day 1 Accumulation Ratio|Day 5 and Day 1|All participants with pharmacokinetic measurements on Days 1 and 5|||Ratio||Full Range|Geometric Mean
1217647|NCT00754130|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.~Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.|||participants|||Number
1217648|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a t1/2 measurement|||hr||Standard Deviation|Mean
1217649|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a C24hr measurement|||nmol/L||Standard Deviation|Mean
1217650|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Tmax measurement|||hr||Full Range|Median
1217651|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Cmax measurement|||nmol/L||Standard Deviation|Mean
1218259|NCT00749580|Secondary|Virologic Suppression of < 75 Copies/ml at 48 Weeks||at 48 weeks for each patient||||participants|||Number
1217654|NCT00754065|Other Pre-specified|The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
1217655|NCT00754065|Other Pre-specified|Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6|Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217656|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217657|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217658|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217659|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217660|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217661|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217662|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Item Satisfaction|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217663|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Item Satisfaction|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217664|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – General Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217665|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – General Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217666|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Social Relationship|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217667|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Social Relationship|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217668|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Leisure Time Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217669|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Leisure Time Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217670|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – School/Course Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217671|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – School/Course Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217672|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Household Duties|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217673|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Household Duties|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217674|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217675|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217676|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217677|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217678|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217679|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217680|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217681|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217682|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217683|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217684|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217685|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217686|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217687|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217688|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217689|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217690|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217698|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217699|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217700|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217701|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217702|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217703|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217704|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 13|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217705|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217706|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217707|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217708|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217709|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217710|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217711|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1217712|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217713|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217714|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217715|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217716|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217717|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217718|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217719|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1217720|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217721|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217722|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217723|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217724|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217725|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217726|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217727|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217728|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217729|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217730|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217731|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217732|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217733|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217734|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217735|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217736|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217737|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217738|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217739|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217740|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217741|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217742|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217743|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217744|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217745|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217746|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217747|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217748|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217749|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217750|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217751|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217752|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217753|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217754|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217755|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1217756|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217757|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217758|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217759|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217760|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
1217761|NCT00754065|Secondary|Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
1217762|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.|From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217763|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.|From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217764|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217765|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217766|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217767|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1217768|NCT00754065|Secondary|The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.|From Baseline to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
1217769|NCT00754065|Secondary|The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.|From Baseline to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
1217770|NCT00754065|Primary|The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in Full Analysis Set (FAS) with assessment for this outcome measure|||mm||Standard Deviation|Mean
1217771|NCT00754052|Secondary|Mean Change From Baseline if the Forward Memory and Attention Sustained Sub-tests of the Leiter International Performance Scale - Revised (Leiter-R)|Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent was planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
1217772|NCT00754052|Secondary|Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER)|TOVER, a subject performance-based measure of expressive language function was planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
1217773|NCT00754052|Secondary|Mean Change From Baseline in Additional Analyses of the VABS-11/PCRF|Additional analyses of the VABS-II/PCRF were planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
1217774|NCT00754052|Primary|Mean Change From Baseline in Vineland-II Adaptive Behavior Scale (VABS-II) Parent/Caregiver Rating Form (PCRF) Score Using Last Observation Carried Forward (LOCF)|Mean change from Baseline from Visit 1 (baseline) to Visit 3 (Week 10 or early termination) in VABS-11/PCRF, a sum of the 9 sub-domain v-scores (3 scores for each of the communication, daily living skills, and socialization domains) using last observation carried forward was planned.|Baseline (Day 0) to Visit 3 (Week 10) or at early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
1217775|NCT00754013|Secondary|Mean Change From(Baseline) to Visit 3(Week 10 or Early Termination) in VABS-II/PCRF Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The planned secondary objectives of the study included further evaluation of efficacy as assessed by additional analyses of the VABS-II/PCRF, by analyses of the Test of Verbal Expression and Reasoning (TOVER), a subject-performance-based measure of expressive language function, and by the Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent. In addition, observed case analyses of these assessments at Week 4 and Week 10 were planned.|Visit 1 (Baseline) to Visit 3 (Week 10 or early termination).|This study was terminated early. Secondary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.||||||
1217776|NCT00754013|Primary|Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The primary objective of the study was evaluation of the efficacy and safety of donepezil hydrochloride in the treatment of the cognitive dysfunction exhibited by children with Down syndrome (DS), aged 6 to 10, as assessed by analysis of VABS-II/PCRF in the domains of communication, daily living skills, and socialization, and as assessed by standard safety measurements.|Visit 0 (Screen), Visits 1 (Baseline), 2, and 3 (or Early Termination).|The planned efficacy analysis was on the intent-to-treat (ITT) population. This study was terminated early. Primary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.||||||
1217777|NCT00753948|Secondary|Methacholine Challenge||During study visits, methacholine challenge will be performed 120 minutes post intervention.|||||||
1217778|NCT00753948|Secondary|Lung Function as Measured by Plethysmography||During study visits, measures are obtained prior to intervention (intravenous or nebulized) and 60, 120 minutes post intervention.|||||||
1217779|NCT00753948|Primary|Exhaled Levels of Nitric Oxide|Nitric Oxide was measured applying a real time technique for measurement of Nitric Oxide in Exhaled Breath Condensate. Elevated Nitric Oxide in exhalate is a measure of elevated production of NO in conditions such as underlying inflammation and/or oxidative stress|Exhaled NO was reported as the mean of three values within 10% of each other.||||ppb (parts per bilion)||Standard Deviation|Mean
1217780|NCT00753935|Primary|Change in Serum Thromboxane B2|Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.|after 2 weeks on aspirin||||ng/mL||Inter-Quartile Range|Median
1217781|NCT00753922|Post-Hoc|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications|The safety analyses were conducted in accordance with the FDA November 17, 2006 “Guidance for Industry and FDA Staff – Saline, Silicone Gel, and Alternative Breast Implants.” The study investigator assessed any complications durign study follow-up visits in alignment with this guidance. Time of occurrence was calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. Complications with an incidence > 5.0% are reported.|10 years|All Enrolled Subjects|||percentage of subjects||95% Confidence Interval|Number
1217782|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
1217783|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
1217784|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
1217785|NCT00753922|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects|||centimeters||Standard Deviation|Mean
1217786|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included|||percentage of subjects||95% Confidence Interval|Number
1217787|NCT00753896|Secondary|Change in Blood Pressure From Baseline to Week 52|Change in Systolic and Diastolic Blood Pressure from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmHg||Standard Error|Mean
1217788|NCT00753896|Secondary|Change in Triglycerides From Baseline to Week 52|Change in Triglycerides from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
1217789|NCT00753896|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 52|Change in HDL from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
1217790|NCT00753896|Secondary|Change in Total Cholesterol From Baseline to Week 52|Change in Total Cholesterol from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
1217791|NCT00753896|Secondary|Change in Body Weight From Baseline to Week 52|Change in body weight from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||kg||Standard Error|Mean
1217792|NCT00753896|Secondary|Change in Fasting Serum Glucose From Baseline to Week 52|Change in fasting serum glucose from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
1217793|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 52|Percentage of patients achieving HbA1c <=6.5% at endpoint (for patients with HbA1c >6.5% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 6.5%. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
1217794|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 52|Percentage of patients achieving HbA1c <=7% at endpoint (for patients with HbA1c >7% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 7% . Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
1217795|NCT00753896|Secondary|Change in HbA1c From Baseline to Week 52|Change in HbA1c from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of total hemoglobin||Standard Error|Mean
1217814|NCT00753688|Secondary|Change From Baseline in Heart Rate|Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||beats per minute||Standard Deviation|Mean
1219148|NCT00740714|Secondary|Adverse Experiences: Anxiety|Number of participants with anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1217796|NCT00753896|Primary|Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.|||events per subject-year||Standard Error|Mean
1217797|NCT00753896|Primary|Percentage of Patients Experiencing Adverse Events|Percentage of patients experiencing treatment-emergent adverse events over 52 weeks|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.|||percentage of patients|||Number
1217798|NCT00753766|Secondary|Rate of Return to the Operating Room||6 weeks|||||||
1217799|NCT00753766|Secondary|A Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia||6 weeks|||||||
1217800|NCT00753766|Secondary|Length of Hospital Stay||6 weeks|||||||
1217801|NCT00753766|Secondary|Occurrence of Wound Infection in the 30 Day Post-operative Period||6 weeks|||||||
1217802|NCT00753766|Secondary|Change in A1c & Fructosamine From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control, Fructosamine Provides a Measure of Shorter-term Glucose Control [2-3 Wks])||6 weeks|||||||
1217803|NCT00753766|Secondary|Percent of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications||6 weeks||||participants|||Number
1217804|NCT00753766|Secondary|Participant Adherence With the Study Protocol (i.e. Attending Study Visits, CGMS Studies||6 weeks|||||||
1217805|NCT00753766|Primary|Percent of Screened Participants That Are Eligible and Choose Participation||6 weeks||||percentage of potential participants|||Number
1217806|NCT00753714|Secondary|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes|Oct 2008- Dec 2011||||Adverse Events|||Number
1217807|NCT00753714|Secondary|Duration of Response||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
1217808|NCT00753714|Secondary|Overall Objective Response||Oct 2008- dec 2011||||Participants|||Number
1217809|NCT00753714|Secondary|Overall Survival||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
1217810|NCT00753714|Primary|Progression Free Survival||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
1217811|NCT00753688|Secondary|Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function (based on the institutional lower limit of normal [LLN]). LVEF was assessed at BL, Week 12, and every second scheduled visit thereafter until study drug discontinuation and end of treatment or as clinically indicated by using multi-gated acquisition scan (MUGA) or echocardiogram (ECHO). Absolute change from BL was calculated as the on-study value minus the baseline value (LVEF is calculated as a percentage).|Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
1217812|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin|Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
1217813|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count|Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
1217897|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.|9 months|Intent to Treat population|||participants|||Number
1217815|NCT00753688|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in on-therapy SBP and DBP was calculated as the values at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population: all participants who had started their allocated treatment (at least one dose of the study drug). Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||Millimeters of mercury||Standard Deviation|Mean
1217816|NCT00753688|Secondary|PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization [WHO] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)|"ITT Population. The ns in the category titles represent the number of participants in each treatment arm with the indicated STS."|||weeks||95% Confidence Interval|Median
1217817|NCT00753688|Secondary|Duration of Response Assessed by the Independent Radiologist and the Investigator|Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.|||weeks||95% Confidence Interval|Median
1217818|NCT00753688|Secondary|Time to Response Assessed by an Independent Radiologist and the Investigator|Time to response was defined as the time from the date of randomization until the date of first documented evidence of CR or PR (whichever status was recorded first). The Kaplan-Meier method was used for time to response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.|||weeks||95% Confidence Interval|Median
1217819|NCT00753688|Secondary|Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator|Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).|From the start of treatment until disease progression (assessed for an average of 10 months)|ITT Population|||participants|||Number
1217820|NCT00753688|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. The length of this interval was calculated as the date of death minus the date of randomization plus 1 day. Participants who were alive at the time of analysis were censored at the date of last follow-up. The interim OS analysis was conducted when 215 (77 percent [%]) of the 279 required death events had occurred in the study. The Kaplan-Meier method was used for OS estimates.|From the date of randomization until 215 deaths (assessed for an average of 12 months)|ITT Population|||months||95% Confidence Interval|Median
1217821|NCT00753688|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)|Intent-to-Treat (ITT) Population: all randomized participants analyzed in the treatment arm they were allocated by randomization.|||weeks||95% Confidence Interval|Median
1217822|NCT00753675|Secondary|Overall Survival|OS is defined from the date of randomization to death|up to 1032 days|ITT|||Days||95% Confidence Interval|Median
1217823|NCT00753675|Secondary|Duration of Response (DOR)|DOR is defined from the date of first documentation of response until date of PD or death|up to 1032 days|ITT (best response of CR or PR only)|||Days||95% Confidence Interval|Median
1217824|NCT00753675|Secondary|Disease Control Rate (CR+PR+SD)|DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis|up to 1032 days|ITT|||Partecipants|||Number
1217825|NCT00753675|Secondary|Objective Tumor Response Rate (CR+PR),|Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD|up to 1032 days|ITT|||Participants|||Number
1217826|NCT00753675|Primary|Progression Free Survival|Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).|up to 1032 days|ITT|||days||95% Confidence Interval|Median
1219149|NCT00740714|Secondary|Adverse Experiences: Insomnia|Number of participants with insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1217827|NCT00753649|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period up to Last subject last visit on 03/12/2013|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.|||Subjects|||Number
1217828|NCT00753649|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day (Days 0-30) post vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.|||Subjects|||Number
1217829|NCT00753649|Secondary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1217830|NCT00753649|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL|The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1217831|NCT00753649|Secondary|Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)|A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1217832|NCT00753649|Secondary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1217833|NCT00753649|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL|For this assay, 1 μg/mL was considered as the seropositivity cut-off.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1217834|NCT00753649|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1217835|NCT00753636|Secondary|Pharmacokinetic Data – Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine|Mean Plasma Concentration (+/- SD ng/mL)|1 year||||ng/mL||Standard Deviation|Mean
1217836|NCT00753636|Secondary|Change in Motor UPDRS Scores: Baseline vs. Final Visit|"Baseline visit = Week 0 Final visit = Week 12~Unified Parkinson's Disease Rating Scale (UPDRS)is made up of the following sections:~Part I: evaluation of Mentation, behavior, and mood Part II: self evaluation of the activities of daily life Part III: clinician-scored motor evaluation Part IV: Hoehn and Yahr stating of severity of Parkinson disease. Part V: Schwab and England ADL scale Only part three was used for this assessment.~The higher the UPDRS score, the greater the disability from PD.~The range for scores for Section III is 0 to 108."|12 weeks||||UPDRS Part III Score||Standard Deviation|Mean
1217837|NCT00753636|Secondary|Number of Participants That Completed the Study at Each Dose Level of Isradipine||1 year||||Participants|||Number
1217838|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent|"At the time of enrollment, some patients were currently being treated with antihypertensive agents including Propanolol, Toprol, Lisinopril, Diovan, Norvasc.~HTN+: Participants on an antihypertensive agent HTN-: Participants not on an antihypertensive agent"|1 year||||Participants|||Number
1217839|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose of Isradipine|Tolerability= maximum tolerated dose|1 year||||Participants|||Number
1217840|NCT00753636|Secondary|Safety of the Standard Titration Schedule in PD Population as Measured by the Number of Patients That Are Able to Increase the Dose to 20 mg Daily||1 year||||Participants|||Number
1217841|NCT00753636|Primary|Tolerability of Isradipine Based on the Number of Participants That Complete the Study||1 year||||Participants|||Number
1217842|NCT00753623|Primary|Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments|Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.|VAS score at baseline and after the treatment period|Only 15 subjects completed both treatment phases so we only included these subjects in the analysis.|||units on a scale||Standard Deviation|Mean
1217843|NCT00753545|Secondary|Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1217844|NCT00753545|Secondary|Trial Outcome Index(TOI)Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1217845|NCT00753545|Secondary|FACT-O Symptom Index (FOSI) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1217846|NCT00753545|Secondary|Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
1217847|NCT00753545|Secondary|Improvement Rate for Trial Outcome Index (TOI)|The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
1217848|NCT00753545|Secondary|Improvement Rate for FACT-O Symptom Index (FOSI)|The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
1217849|NCT00753545|Secondary|Time to Earlier of CA-125 or RECIST Progression|Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1217850|NCT00753545|Secondary|RECIST and CA-125 Response Separately and Combined|RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.||||Participants|||Number
1217851|NCT00753545|Secondary|Best Objective Response|Best overall response from radiologic assessments. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.||||Participants|||Number
1217852|NCT00753545|Secondary|Best Percentage Change in Cancer Antigen 125 (CA-125) Levels|Best percentage change from baseline in CA-125 level|CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.|A subset of the FAS with baseline and at least 1 follow-up value of CA-125|||percentage of change||Full Range|Median
1217853|NCT00753545|Secondary|Percentage Change From Baseline in Tumour Size at Week 24|Percentage change from baseline to Week 24 in target tumour size.|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.|||Percent change in tumour size||Full Range|Least Squares Mean
1217854|NCT00753545|Secondary|Duration of Response|Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn.|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1217855|NCT00753545|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS]|Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).||||percentage of participants|||Number
1217856|NCT00753545|Secondary|Objective Response Rate (ORR) (According to RECIST)|For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline|||percentage of participants|||Number
1217857|NCT00753545|Secondary|Overall Survival (OS)|OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.|Follow up every 12 weeks post progression, assessed maximum up to 90 months.||||Months||95% Confidence Interval|Median
1217898|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.|30 days|Intent to Treat population|||participants|||Number
1217858|NCT00753545|Primary|Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])|PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1217859|NCT00753519|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment).|baseline, 1 day post iTBS||||units on a scale||Standard Deviation|Mean
1217860|NCT00753519|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|baseline, 1 day post iTBS||||units on a scale||Standard Deviation|Mean
1217861|NCT00753519|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post iTBS||||seconds||Standard Deviation|Mean
1217862|NCT00753519|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real iTBS and sham iTBS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline, 1 day post intervention, and 1 month post intervention.|baseline, 1 day post iTBS||||seconds||Standard Deviation|Mean
1217863|NCT00753506|Secondary|Change in Cognitive Functioning as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status and Change in Functional Performance as Measured by the UCSD Performance-based Skills Assessment.||10 weeks (weeks 2 & 12)|||||||
1217864|NCT00753506|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale. PANSS positive symptom scores and negative symptom scores each range from 7 to 49 units on a scale.|10 weeks (weeks 2 & 12)||||units on a scale||Standard Deviation|Mean
1217865|NCT00753454|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects."|||units on a scale||Standard Deviation|Mean
1217866|NCT00753454|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects."|||units on a scale||Standard Deviation|Mean
1217867|NCT00753454|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
1217868|NCT00753454|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
1219150|NCT00740714|Secondary|Adverse Experiences: Constipation|Number of participants with constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1217869|NCT00753454|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
1217870|NCT00753454|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
1217871|NCT00753454|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
1217872|NCT00753454|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
1217873|NCT00753454|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
1217874|NCT00753454|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
1217875|NCT00753454|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
1217876|NCT00753454|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
1217877|NCT00753454|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
1217899|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|9 months|Intent to Treat population|||percentage of limbs|Participants||Number
1217878|NCT00753454|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects."|||units on a scale||Standard Deviation|Mean
1217879|NCT00753454|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating improvement in activity and a higher score indicating a decline activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 152 are included in this analysis.~Data was not available for 16 subjects."|||percentage of subjects|||Number
1217880|NCT00753454|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 151 are included in this analysis.~Data was not available for 17 subjects."|||percentage of subjects|||Number
1217881|NCT00753454|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 149 are included in this analysis.~Data was not available for 19 subjects."|||percentage of subjects|||Number
1217882|NCT00753454|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 146 are included in this analysis.~Data was not available for 22 subjects."|||units on a scale||Standard Deviation|Mean
1217883|NCT00753454|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 145 are included in this analysis.~Data was not available for 23 subjects."|||units on a scale||Standard Deviation|Mean
1217884|NCT00753454|Secondary|Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects."|||units on a scale||Standard Deviation|Mean
1217885|NCT00753454|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
1217886|NCT00753454|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
1217887|NCT00753454|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
1217888|NCT00753454|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|"A Serious Adverse Event is any untoward medical occurrence that at any dose~results in death,~is life threatening,~requires in-patient hospitalization or prolongation of existing hospitalization,~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect"|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
1217889|NCT00753454|Primary|Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).~TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
1217890|NCT00753454|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).~TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
1217891|NCT00753415|Secondary|Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)|An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.|From pre-vaccination to Week 69|Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.||||||
1217892|NCT00753415|Primary|Number of Participants With Adverse Events (AEs)|This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|All Participants as Treated (APaT) population; all participants who received at least one vaccination.|||Participants|||Number
1217893|NCT00753415|Primary|Number of Participants With Dose-Limiting Toxicity (DLT)|DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.|||Participants|||Number
1217894|NCT00753363|Secondary|Fitness|Maximal oxygen consumption (VO2max) on a treadmill|Baseline and 6 month||||L/min||Standard Error|Mean
1217895|NCT00753363|Secondary|Body Weight||Baseline and 6 month||||kg||Standard Error|Mean
1217896|NCT00753363|Primary|Insulin Sensitivity|Insulin resistance is defined as a reduction in glucose utilization rate elicited by a given insulin concentration. Glucose utilization is measured during a three hour hyperinsulinemic-euglycemic clamp and is presented as a measure of insulin sensitivity. This is one of the most sophisticated methods to measure insulin sensitivity.|Baseline and 6 month||||μmol/kgFFM/min||Standard Error|Mean
1217900|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|30 days|Intent to Treat population|||percentage of limbs|Participants||Number
1217901|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|9 months|Intent to Treat population|||percentage of limbs|Participants||Number
1217902|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|30 days|Intent to Treat population|||percentage of limbs|Participants||Number
1217903|NCT00753337|Secondary|Procedure Success|Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)|9 months|Intent to Treat population|||percentage of participants|||Number
1217904|NCT00753337|Secondary|Lesion Success|Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
1217905|NCT00753337|Secondary|Device Success|Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
1217906|NCT00753337|Secondary|Primary Patency Rate at 9 Months|Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
1217907|NCT00753337|Primary|Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).|Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.|9 months|Intent to Treat population (ITT)|||percentage of participants|||Number
1217908|NCT00753298|Primary|Subject's Sensation When Using Test Catheter|Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1217909|NCT00753298|Primary|Subject's General Satisfaction With Test Catheter|Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1217910|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter After Withdrawal|Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1217911|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Withdrawal|Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1217912|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Insertion|Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1217913|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter Before Insertion|Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1217914|NCT00753272|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains|In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4.|At Day 21 of the first year (2008/2009) of the study.|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.|||Participants|||Count of Participants
1217915|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the second year of the study.|||Titers||95% Confidence Interval|Geometric Mean
1217916|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the first year of the study.|||Titers||95% Confidence Interval|Geometric Mean
1238651|NCT00593840|Secondary|Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms||5 years from completion of treatment||2020-04-30|04/2020||||
1217917|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the second year of the study.|||Titers||95% Confidence Interval|Geometric Mean
1217918|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the first year of the study.|||Titers||95% Confidence Interval|Geometric Mean
1217919|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
1217920|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
1217921|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
1217922|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
1217923|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Days||Full Range|Mean
1217924|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
1217925|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Days||Full Range|Mean
1217972|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Liver Fat|For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).|Baseline to week 24|ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter.|||Percentage (%) IHL||Standard Deviation|Mean
1217926|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
1217927|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Days||Full Range|Mean
1217928|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
1217929|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Days||Full Range|Mean
1217930|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
1217931|NCT00753272|Secondary|Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.~Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1217932|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1217933|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)|The Two-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented in each year of the study|||Participants|||Count of Participants
1217934|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)|The One-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented during the first year of the study.|||Participants|||Count of Participants
1217935|NCT00753272|Secondary|Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine|Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
1217936|NCT00753272|Secondary|Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.|The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
1217937|NCT00753272|Secondary|Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.|"Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough.~The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v)."|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
1217938|NCT00753272|Secondary|Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.|Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
1217939|NCT00753272|Secondary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
1217940|NCT00753272|Primary|Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset, which included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.|||Titers||95% Confidence Interval|Geometric Mean
1217941|NCT00753272|Primary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))|The One-Dose According-To-Protocol cohort for efficacy included eligible subjects from the One-Dose Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
1217942|NCT00753220|Primary|Maximum Tolerated Dose (MTD)|"PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer.~ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD."|Up to 1 year||||intratumorally delivered cells|||Number
1217943|NCT00753142|Secondary|Number of Participants With Beta-cell Failure|Pancreatic beta-cells can adapt to insulin resistance during the early stages of diabetes but continuous exposure of beta-cells to prolonged hyperglycemia can cause irreversible damage due to glucotoxicity. This study aimed to evaluate whether hyperglycemia-induced reduced beta-cell failure was the result of beta-cell exhaustion or beta-cell desensitization, however, no participants experienced beta-cell failure so this original analysis could not be performed.|Hour 20||||Participants|||Count of Participants
1217970|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Calories Expended for Physical Activity|Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Kilocalorie (kcal)/week||Standard Deviation|Mean
1217944|NCT00753142|Primary|First-Phase Insulin Release (FPIR)|An arginine stimulation test was used to evaluate beta-cell function and insulin secretion. Increased glucose in the blood causes insulin to be released, beginning with a spike in insulin in the first 10 minutes and plateauing 2 to 3 later. Diminished first-phase insulin release is an early indicator of beta-cell dysfunction. Two sequential arginine stimulation tests were performed, the first set before and the second after completion of the 20-hour dextrose infusion. The first-phase insulin release (FPIR) was calculated as the sum of the insulin levels at 2, 3, 4, and 5 minutes after the arginine infusion. FPIR is expected to rise after the dextrose (glucose) infusion and FPIR generally rises less in persons with impaired glucose tolerance.|Hour 0, Hour 20||||microunits/ml||Standard Deviation|Mean
1217945|NCT00753012|Primary|Blood Pressure at Maximum Exertion|Diastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET)|3-6 months||||mmHg||Standard Deviation|Mean
1217946|NCT00753012|Primary|Cardiac Function Index (E/A Ratio)|Left ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months||||cm/sec/cm/sec||Standard Deviation|Mean
1217947|NCT00753012|Primary|Left Ventricle Size|Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months|14 subjects completed endpoint TTE; one HTN subject missed the scheduled endpoint TTE appointment.|||mm||Standard Deviation|Mean
1217948|NCT00752986|Secondary|Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes||Continuous assessment of safety.|||||||
1217949|NCT00752986|Secondary|Overall Survival||Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.|||||||
1217950|NCT00752986|Secondary|Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)||Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.|||||||
1217951|NCT00752986|Primary|Event Free Survival|Success rate (patients without progression and still on treatment at 24 weeks|Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.|||||||
1217952|NCT00752973|Secondary|Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.|To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|A total of 12 subjects were enrolled. All of them used the study drug for at least one dose of the treatment. At Day 0 the study drug was to be used. At Day 7 if subject presented with live lice they were provided a second treatment. The subjects may used it for 1 (for subjects not requiring retreatment) or 2 (for retreated subjects).|||participants|||Number
1217953|NCT00752973|Primary|Participants Clinically Cured of Head Lice 14 Days After Last Treatment|No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects).|Day 7±1 and Day 14 or Day 21|No statistical analysis provided for Clinical Cure|||participants cured of lice|||Number
1217954|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 24 hrs (Day 1)||||percentage of participants|||Number
1217955|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 1 hr (Day 0)||||percentage of participants|||Number
1217956|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participant had wheezing as medical history which continued without increase in severity throughout the treatment."|at Baseline||||percentage of participants|||Number
1217957|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).|"Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals.~Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.~Mean percent reduction = (Post treatment value – Baseline)/ Baseline x100."|Change from baseline to 24 hrs (1 day)|11 subjects with obtained blood sample. subject 01-004: At Visit 2, Day 1 Lab could not perform testing due to sample not suitable for testing. Because only 2ml blood was able to collected after multiple attempts.|||percentage change in cholinesterase||95% Confidence Interval|Mean
1217969|NCT00752726|Secondary|Change From Baseline to Week 24 in Quality of Life (QoL) Scores.|QoL scores were measured using an Impact of Weight Quality of Life (IWQoL) Questionnaire, which scored the responses at a scale of 1 to 5(1, never true, to 5, always true): QoL scales for physical function, self-esteem, sexual life, public distress, and work were evaluated, and summarized in a total score. A higher value indicated a better quality of life.|Baseline to week 24|This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
1218020|NCT00751998|Secondary|Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures.||Post Procedure|||||||
1217958|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).|"Each patient (aged 6 – 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals.~If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines.~Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.~Mean percent change (reduction) = (Post treatment value – Baseline)/ Baseline x100."|Change from Baseline to 1 hour|"10 subjects with obtained blood sample. subject 01-003: Study coordinator was unable to obtain blood sample post treatment at Visit 1, Day 0.~subject 01-004: At Visit 1 Day 0 (post treatment), Blood sample could not be obtained even after two attempts."|||percentage change in cholinesterase||95% Confidence Interval|Mean
1217959|NCT00752895|Secondary|Number of Antibiotic Use Days|An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.|3 months|Participants who returned respiratory symptom and antibiotic use diaries. Note that a few participants failed to provide antibiotic use diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.|||days||Standard Deviation|Mean
1217960|NCT00752895|Primary|Acute Respiratory Infection (ARI) Days|An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.|3 months|Participants who returned a respiratory symptom diary between January and March. Note that a few participants failed to provide respiratory diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.|||days||Standard Deviation|Mean
1217961|NCT00752791|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 1-19) and Evaluation Period (Weeks 20-25). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 25|Safety Analysis Set. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.|||percentage of participants|||Number
1217962|NCT00752791|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 25 weeks.|Full analysis set where data was available for each time interval (indicated by N).|||percentage of participants||95% Confidence Interval|Number
1217963|NCT00752791|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). One patient did not have central lab hemoglobin value during a regularly scheduled visit during weeks 2-5.|Up to 25 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).|||g/dL||Standard Deviation|Mean
1217964|NCT00752791|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 1 - 19) and Evaluation Period (Weeks 20 -25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. One patient had the last study visit during the titration period and the transfusion after the titration period. This patient is excluded from the summary of evaluation period.|Up to 25 weeks.|Full Analysis Set.|||percentage of participants||95% Confidence Interval|Number
1217965|NCT00752791|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|Percentage of participants with a mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from measured at Weeks 20 to 25) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.|Baseline and Week 20 to Week 25.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
1217966|NCT00752791|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Week 20 to Week 25). The target hemoglobin range was 10.0 to 12.0 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 20 to Week 25.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
1217967|NCT00752791|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The primary efficacy endpoint was the mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to Enrollment and the hemoglobin on the day of Enrollment) and the Evaluation Period (mean hemoglobin from Weeks 20 to 25).|Baseline and Week 20 to Week 25.|The Full Analysis Set included all patients who received at least 1 dose of peginesatide injection and where data was available at both time points (indicated by N).|||g/dL||Standard Deviation|Mean
1217968|NCT00752726|Secondary|Selectivity Index at Week 24|The selectivity index (SI) was used as a measure of orlistat’s ability to target abdominal VAT loss compared to total adipose tissue lost. SI was calculated using the following equation: Mean % change in VAT divided by Mean % change in total fat mass.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment, only in Orlistat 60 mg group. This analysis was not carried out for placebo group.|||Ratio|||Number
1218021|NCT00751998|Secondary|Ability to Visualize and Access Various Targeted Anatomic Areas.||Procedure|||||||
1217973|NCT00752726|Secondary|Change From Baseline to Week 24 in Waist Circumference|Waist circumference was measured against the skin, without interference from clothing, at the level midway between the lateral lower rib margin and the iliac crest in standing position.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||cm||Standard Deviation|Mean
1217974|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Body Fat|Body fat was assessed through Bioelectrical Impedance Analysis (BIA).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Percentage (%) body fat||Standard Deviation|Mean
1217975|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Fat Mass|Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
1217976|NCT00752726|Secondary|Change From Baseline to Week 24 in Body Weight|Participants were weighed at least twice until two consecutive measurements were within 0.5 kg of each other and the average of the two measurements was recorded.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
1217977|NCT00752726|Secondary|Change From Baseline to Week 12 in Abdominal VAT Mass|Abdominal VAT mass from baseline to week 12 was measured by CT scan.|Baseline to week 12|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
1217978|NCT00752726|Primary|Change From Baseline to Week 24 in Abdominal VAT Mass|VAT was measured by the computed tomography (CT) scan.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
1217979|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission Off Steroids in the Interventional Phase|"Number of participants who were in clinical remission and off systemic corticosteroids at visit.~The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1217980|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1217981|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI-100 at Weeks 14-16, 24 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical response was defined as a 100-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1217982|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI at Weeks 14-16 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical response was defined as a 70-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at week 14-16 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1217983|NCT00752622|Secondary|Number of Participants That Required Treatment Optimization in the Observational Phase|"Participants required treatment-optimization if:~Disease progression/lack of response after entering observational phase; or~Participant was successfully randomized into the interventional phase~The definition of loss of response was as follows:~- An increased HBI score >= 3 points over the week 10 evaluation score and a CDAI score >= 175.~Despite:~having received regular infusions of infliximab every 8 weeks during the observational phase with a maximum interval of no > 10 weeks between each infusion, and~having received previous doses of infliximab of >= 4.7 mg/kg."|Week 54 in the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication. Of the 98 participants in the ELIG population, 65 participants entered the observational phase.|||Participants|||Number
1217984|NCT00752622|Primary|Mean Change From Baseline in Harvey-Bradshaw Index (HBI)|Mean change in HBI score from Baseline to Week 10, 30, and 54. HBI score consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is the sum of individual parameters. Minimum score is 0 and no pre-specified maximum score as it depends on the number of liquid stools. Lower scores indicate better well being. Clinical response/ long-term response is defined as a decrease by 3 or more points from baseline value. Loss of response is defined as an increase of >= 3 points.|Baseline and Evaluation Week 10, Week 30 and Week 54 of the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1218022|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management.||Procedure or at 12 months|||||||
1218023|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis.||Procedural through end of study|||||||
1217985|NCT00752622|Primary|Number of Participants Who Had a Clinical Response Using the Crohn's Disease Activity Index (CDAI) at Week 24 in the Interventional Phase|The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Participants provided completed CDAI diary cards and were considered as responders in the interventional phase if their CDAI score at week 24 was decreased by 70 points or greater over their CDAI score at randomization into the interventional phase, or if their week 24 CDAI score is <= 150. Baseline is value at randomization.|Baseline and Week 24 of the Interventional phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1217986|NCT00752609|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 20|Safety Analysis set, which included all patients who received at least 1 dose of study drug. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.|||percentage of participants|||Number
1217987|NCT00752609|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals.|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full analysis set where data was available for each time interval (indicated by N).|||percentage of participants||95% Confidence Interval|Number
1217988|NCT00752609|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24).|Up to 24 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).|||g/dL||Standard Deviation|Mean
1217989|NCT00752609|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full Analysis Set.|||percentage of participants||95% Confidence Interval|Number
1217990|NCT00752609|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|"Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Baseline and Week 19 to Week 24.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
1217991|NCT00752609|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 19 to Week 24|Full Analysis Set where data was available.|||percentage of participants||95% Confidence Interval|Number
1217992|NCT00752609|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24).|Baseline and Week 19 to Week 24.|The Full Analysis Set including all patients who received at least 1 dose of study drug where data was available (indicated by N).|||g/dL||Standard Deviation|Mean
1217993|NCT00752232|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1217994|NCT00752232|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Z-score||Standard Deviation|Mean
1218024|NCT00751998|Primary|Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.||During Procedure||||percent||95% Confidence Interval|Number
1217995|NCT00752232|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1217996|NCT00752232|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1217997|NCT00752232|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geometric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
1217998|NCT00752232|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
1217999|NCT00752232|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1218000|NCT00752232|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1218001|NCT00752232|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1218002|NCT00752219|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
1218003|NCT00752219|Secondary|Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
1218004|NCT00752219|Secondary|Number of Participants With Clinical Response in CE Participants at the End of IV Therapy|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|End of IV therapy: From Day 5 to Day 14|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
1218005|NCT00752219|Secondary|Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|Test of cure visit: 2 weeks post-therapy (Day 28)|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
1219151|NCT00740714|Secondary|Adverse Experiences: Back Pain|Number of participants with back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1218006|NCT00752219|Secondary|Number of Participants With Microbiological Response at the Late Follow-up Visit|Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1218007|NCT00752219|Secondary|Number of Participants With Microbiological Response at the End of IV Therapy|Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.|End of IV therapy: From Day 5 to Day 14|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1218008|NCT00752219|Secondary|Number of Participants With Microbiological Response at the Test of Cure Visit|Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.|Test of cure visit: 2 weeks post-therapy (Day 28)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1218009|NCT00752219|Secondary|Number of Participants With Clinical Response at the Late Follow-up Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1218010|NCT00752219|Secondary|Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.|End of IV therapy: From Day 5 to Day 14|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1218011|NCT00752219|Primary|Number of Participants With Clinical Response at the Test of Cure (TOC) Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.|Test of cure visit: 2 weeks post-therapy (Day 28)|ME set:clinically evaluable(CE)subset with atleast 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. CE set:participants diagnosed with intraperitoneal infection confirmed by operative findings with adequate therapy and information to determine clinical outcome at specified visit.|||participants|||Number
1218012|NCT00752128|Secondary|Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition||12 Months|Intention to treat|||percentage of participants|||Number
1218013|NCT00752128|Primary|Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)||12 Months|Analysis per intention to treat|||percentage of participants|||Number
1218014|NCT00752102|Primary|Coronary Artery (CAC) Score Progression|"coronary artery (CAC) score difference between baseline and followup CT scans. It was measured in Agatston units. These are units of amount of calcification in the blood vessels so it's a continuous variable. The amount of calcium was quantified with the Agatston scoring method. Calcium scores were adjusted with a standard calcium phantom that was scanned along with the participant. The phantom contained known calcium density bars and provided a way to calibrate the x-ray attenuation level.~Participants scoring CAC >400 are considered to be at risk for having at least one coronary lesion."|48 weeks||||Agatston units||Standard Deviation|Mean
1218015|NCT00752089|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"PP population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."|||ug*F/cm^3||95% Confidence Interval|Least Squares Mean
1218016|NCT00752089|Primary|Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Per-Protocol (PP) population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."|||% SMHR||95% Confidence Interval|Least Squares Mean
1218017|NCT00751998|Secondary|Health Resources Utilization (Health Economics)||Procedure through end of study.|||||||
1218018|NCT00751998|Secondary|Device Durability and Device Performance.||Procedure|||||||
1218019|NCT00751998|Secondary|Safety||Procedural through end of study|||||||
1218025|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D|"The EQ-5D is a standardized instrument for use as a generic measure of the quality of health-related life and of health outcome.~The EuroQoL EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.~Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL|||units on a EuroQol EQ-5D scale||Standard Deviation|Mean
1218026|NCT00751972|Secondary|Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days|"The 6MWT is a simple test which does not require expensive equipment or advanced training for technicians. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. The patient can stop or slow down at any time and then resume walking, depending on his/her degree of fatigue.~A longer distance walked is indicative of a better outcome."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of 6 minute walk distance.|||meters||Standard Deviation|Mean
1218027|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|"KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.~The KCCQ’s questions are used to calculate scores in ten domains:~Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall Summary: a combined measure of all the above~For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL.|||units on a KCCQ scale||Standard Deviation|Mean
1218028|NCT00751972|Secondary|Incidence of All Device Failures and Device Malfunctions|The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Number of events|||Number
1218029|NCT00751972|Secondary|Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects|Adverse events are only provided for patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS). Adverse events as described by INTERMACS for the contemporaneous control population were not a part of the agreement for analysis and thus not provided by INTERMACS, and so not included in the Adverse Event Module and relevant Outcome Measures for comparison.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||percentage of patients|||Number
1218030|NCT00751972|Secondary|Survival to 180 Days|All subjects will be followed for date of death until 180 days.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Percentage of participants with survival|||Number
1218031|NCT00751972|Primary|The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful.|The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.|180 days|The primary effectiveness analyses was performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Percentage of participants with success|||Number
1218032|NCT00751933|Secondary|Symptom Score Improvement of 2 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months|||||||
1218033|NCT00751933|Primary|Symptom Score Improvement of 3 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months|||||||
1218034|NCT00751881|Other Pre-specified|Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);~Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin (TB) >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."|||participants|||Number
1218043|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score|"EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.~EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).~Baseline adjusted least-squares means at Week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on EDSS score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1218035|NCT00751881|Secondary|Extension Treatment Period: ARR: Poisson Regression Estimate|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. A relapse is defined as the appearance of a new clinical sign/symptom or clinical worsening of a previous sign/symptom (one that had been stable for at least 30 days) that persists for a minimum of 24 hours in the absence of fever. Relapse was confirmed by an increase in EDSS score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.|||relapses per year||95% Confidence Interval|Number
1218036|NCT00751881|Secondary|Extension Treatment Period: Time to Disability Progression|"Probability of disability progression since the randomization of the core period was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12 week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].~Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event free for the amount of time t. Probability of event at time t was 1 minus the probability of being event-free for the amount of time t."|Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.|||percent probability||95% Confidence Interval|Number
1218037|NCT00751881|Secondary|Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|"Safety population: all randomized participants who received at least 1 dose of investigational product.~Two participants in placebo of core study received teriflunomide and were analyzed according to teriflunomide dose.~One participant in teriflunomide 14 mg in core study group who received 7 mg was analyzed in teriflunomide 7 mg group."|||participants|||Number
1218038|NCT00751881|Secondary|Core Treatment Period: Overview of Adverse Events|Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."|||participants|||Number
1218039|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for each summary score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1218040|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|"SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.~Two summary scores are obtained:~the physical health component summary score,~the mental health component summary score.~Both scores range from 0 to 100 and a high score indicates a more favorable health state.~Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures [MMRM] on each summary score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1218041|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1218042|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score|"FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1223626|NCT00711009|Secondary|Mean Change From Baseline in Creatinine (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1218044|NCT00751881|Secondary|Core Treatment Period: Time Without Relapse|"Probability of no relapse at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse.~Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population|||percent probability||95% Confidence Interval|Number
1218045|NCT00751881|Secondary|Core Treatment Period: Time to Disability Progression|"Probability of disability progression at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12-week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].~Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population|||percent probability||95% Confidence Interval|Number
1218046|NCT00751881|Primary|Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate|"ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||relapses per year||95% Confidence Interval|Number
1218047|NCT00751790|Secondary|LH Increase|% of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st & 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts|day 1 and day 169|||||||
1218048|NCT00751790|Primary|Achievement of Castration and Maintenance of Castration|Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).|at Day 29||||percentage of enrolled patients|||Number
1218049|NCT00751777|Primary|Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|"Definition of SCR:~Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline~Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline"|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||percentage of participants||95% Confidence Interval|Number
1218050|NCT00751777|Primary|Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||ratio||95% Confidence Interval|Number
1218051|NCT00751777|Secondary|Evaluation of Duration of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group||13 months|||||||
1218052|NCT00751777|Secondary|Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear||1 month|||||||
1218053|NCT00751777|Secondary|Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch||7 months|||||||
1218054|NCT00751777|Primary|Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo||Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1218055|NCT00751634|Secondary|Number of Participants With Arrhythmia|New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm|Six hours||||participants|||Number
1218056|NCT00751634|Secondary|Number of Participants With Hypotension|New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period|six hours||||participants|||Number
1218057|NCT00751634|Secondary|Number of Participants With Severe Shivering|"Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall~Mild: shivering localized to the neck and/or thorax only~Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)~Severe: shivering involves gross movements of the trunk and upper and lower extremities"|six hours|All participants were analyzed for the outcome of BSAS=3|||participants|||Number
1218058|NCT00751634|Secondary|Time From Start of Cooling Device to Core Temperature < 100.4F|For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F|Six hours||||hours||Standard Deviation|Mean
1218529|NCT00746863|Secondary|In-hospital Medication Amounts|Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized.|From surgery until discharge, average||||number of pills||Standard Deviation|Mean
1218059|NCT00751634|Primary|Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care|Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.|baseline, one, two and six hours after application.||||degrees F||Standard Deviation|Mean
1218060|NCT00751621|Secondary|Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion|The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period.|||AEs per infusion|Participants||Number
1218061|NCT00751621|Secondary|Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.|The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom laboratory parameter data was collected at both baseline and completion.|||participants|||Number
1218062|NCT00751621|Secondary|Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.|The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom vital signs data was collected at both baseline and completion.|||participants|||Number
1218063|NCT00751621|Secondary|Health Related Quality of Life (Short Form 36 Health Survey)|The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At baseline and at the last available post-baseline observation for each subject (up to 42 months)|The analysis population comprised the Full-Analysis health related quality of life (HRQL) data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age.|||score on a scale||Full Range|Median
1218064|NCT00751621|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
1218065|NCT00751621|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days|||Number
1218066|NCT00751621|Secondary|Annualized Rate of Hospitalization Due to Infections|The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
1218067|NCT00751621|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days|||Number
1218068|NCT00751621|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
1218069|NCT00751621|Secondary|Number of Infection Episodes|Total number of infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||infection episodes|||Number
1218070|NCT00751621|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||infection episodes per subject year|Participants|95% Confidence Interval|Number
1218071|NCT00751621|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs."|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||SBIs per subject year|Participants||Number
1218072|NCT00751621|Primary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Up to 42 months|The “all treated” (AT) safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the “Full Analysis/intention-to-treat” (ITT) data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||g/L||Standard Deviation|Mean
1218073|NCT00751530|Secondary|Percentage of Participants Using Etravirine in Background Regimen|These results report the percent of participants using Etravirine in the background regimen.|Background regimen (no specific time frame)||||Percentage of Participants|||Number
1218074|NCT00751530|Primary|Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 Weeks||||Percentage of Participants|||Number
1218075|NCT00751530|Secondary|Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)|The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.|Baseline||||score||Full Range|Mean
1218076|NCT00751530|Secondary|CD4 Cell Changes Among Participants in PI vs Non-PI Group|CD4 cell counts were measured using standard of care testing via local laboratories.|baseline to 24 Weeks||||cells/mm3||Full Range|Mean
1218077|NCT00751530|Secondary|Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 weeks||||Percentage of participants|||Number
1218078|NCT00751400|Secondary|Number of Dosing Occasions Per Subject That Exceeded 660 mg|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions||Standard Deviation|Mean
1218079|NCT00751400|Secondary|Number of Total Dosing Occasions Per Subject|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions||Standard Deviation|Mean
1218080|NCT00751400|Secondary|Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days|This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing|1 month|number of subjects reporting at least one tablet taken at any point during study|||participants|||Number
1218081|NCT00751400|Secondary|Average Daily Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||mg||Standard Deviation|Mean
1218082|NCT00751400|Secondary|Number of Subjects With and Without More Than 660 mg at Least Once|This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
1218083|NCT00751400|Secondary|Number of Subjects With and Without Next Dose Less Than 22 Hours Later|This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
1218084|NCT00751400|Secondary|Number of Subjects With and Without More Than One Tablet Taken Per Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
1218085|NCT00751400|Secondary|Use Days With and Without Next Dose Less Than 22 Hours Later|Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||days|||Number
1218260|NCT00749580|Primary|Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen|Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.|at 24weeks for each patient||||participants|||Number
1218086|NCT00751400|Secondary|Dosing Occasions With One and More Than One Tablet Taken|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions|||Number
1218087|NCT00751400|Primary|Use Days With One or More Misuse Occasions|Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||days|||Number
1218088|NCT00751348|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 up to Day 43 or Day 57)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1218089|NCT00751348|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1218090|NCT00751348|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
1218091|NCT00751348|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptoms sheet filled in.|||Participants|||Count of Participants
1218092|NCT00751348|Secondary|Antibody Titers Against Varicela Viruses|Antibody titers were presented as geometric mean titers (GMTs).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Titers||95% Confidence Interval|Geometric Mean
1218093|NCT00751348|Secondary|Antibody Concentrations Against Rubella|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1218094|NCT00751348|Secondary|Antibody Concentrations Against Mumps|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||U/mL||95% Confidence Interval|Geometric Mean
1218095|NCT00751348|Secondary|Antibody Concentrations Against Measles|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1218096|NCT00751348|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values|Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.|At 42 days post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Participants|||Count of Participants
1218311|NCT00748956|Secondary|Post-sleep Questionnaire|measure in the morning|on study day 2|data not collected||||||
1218312|NCT00748956|Secondary|Appetite Scale|measure in 2 hours post intranasal administration|on study day 2|data not collected||||||
1218097|NCT00751296|Secondary|Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS).|Assess the time to disease progression and overall survival. (Progressive disease is defined as at least one of the following: more than or equal to 50% increase in the sum of the products of the greatest diameters of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥ 2 cm) or new palpable lymph nodes, more than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the costal margin or appearance of palpable hepatomegaly or splenomegaly not previously present, more than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5.0 x109/L, OR transformation to a more aggressive histology (e.g. Richter’s syndrome or prolymphocytic leukemia with >55% prolymphocytes)).|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.||||percentage of participants||95% Confidence Interval|Number
1218098|NCT00751296|Primary|To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL)|"The primary endpoint was objective response to lenalidomide (Complete response +Partial response) evaluated as per the revised 1996 National Cancer Institute Working Group Guidelines.~Complete response: absence of lymphadenopathy and organomegaly by physical exam and radiology, absence of constitutional symptoms, normal CBC. Bone marrow to be done 2 months after the above criteria are met, must be normocellular, with <30% lymphocytes.~Partial Response: ≥ 50% decrease in the peripheral blood lymphocytes from pre-treatment value, ≥ 50% reduction in lymphadenopathy and organomegaly by physical exam or on CT scan. one or more of the following: neutrophils ≥ 1.5 x109/L, platelets > 100 x109/L or 50% improvement over baseline, hemoglobin > 110 g/L or 50% improvement over baseline (without transfusion)."|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.|Severe toxicities were seen in the first two patients enrolled on the initial protocol. The study was halted and the protocol amended to use a starting dose of lenalidomide 2.5 mg with monthly escalations to a target dose of 10 mg, extended tumor lysis prophylaxis and monitoring. 25 response evaluable patients were enrolled on the amended protocol.|||participants|||Number
1218099|NCT00751179|Secondary|Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice.|Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)|Participants who received succinylcholine and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.|||Minutes||95% Confidence Interval|Geometric Mean
1218100|NCT00751179|Secondary|Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)|Participants who received both rocuronium and sugammadex and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.|||Minutes||95% Confidence Interval|Geometric Mean
1218101|NCT00751179|Secondary|Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups|"Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered pretreatment events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure)."|Up to 7 days post dose|Participants who received sugammadex or succinylcholine.|||participants|||Number
1218102|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1218103|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1218113|NCT00751114|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)|||participants|||Number
1218104|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1218105|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1218106|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1218107|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1218108|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1218109|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1218110|NCT00751140|Secondary|Surgical Outcomes: Mean Lymph Node Count|The mean (range) total lymph node count and lymph node count per procedure category. Between 2009 and 2011, patients with suspected upper urinary tract urothelial carcinoma (UUT-UC) underwent open, laparoscopic, or robot-assisted radical nephroureterectomy (RNU) with modified retroperitoneal lymph node dissection (RPLND).|2 years|Total Participants and Participants Per Procedure Category|||Lymph Nodes||Full Range|Mean
1218111|NCT00751140|Primary|Number of Participants With Pathologically Proven Lymph Node Metastasis|"The number of participants having pathologically proven lymph node metastasis at the time of radical nephroureterectomy (RNU) and modified retroperitoneal lymph node dissection (RPLND).~The primary endpoint is the detection via lymph node dissection of pathological node positive urothelial carcinoma in patients treated with open or laparoscopic nephroureterectomy for upper tract urothelial cancer."|Up to 4 years|All evaluable participants. On histopathological review, one patient had a benign angioma and was excluded from the final data analysis.|||participants|||Number
1218112|NCT00751114|Secondary|Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)|||participants|||Number
1218114|NCT00751114|Secondary|Change in Body Weight From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of the safety population (treated patients) who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||kg||Standard Error|Least Squares Mean
1218115|NCT00751114|Secondary|Lipid Profile: Change From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
1218116|NCT00751114|Secondary|Insulin Dose in the Insulin Glargine Group|Daily dose at the face-to-face visits.|visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value|The population analyzed for this outcome was the safety population defined as randomized patients who received at least one dose of investigational product.|||unit per kg body weight||Standard Deviation|Mean
1218117|NCT00751114|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.~Change = study endpoint - baseline."|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.~Depending on the time point, few values were missing.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
1218118|NCT00751114|Secondary|Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).~Study endpoint was defined as the last available SMFPG mean value collected on-treatment.~Change= study endpoint - baseline"|baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
1218119|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.|||percentage of participants|||Number
1218120|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.|||percentage of participants|||Number
1218121|NCT00751114|Primary|HbA1c: Change From Baseline to Study Endpoint|Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value."|||percent||Standard Error|Least Squares Mean
1218122|NCT00751036|Secondary|Overall Survival (OS)|. OS is defined as the time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff. The median time to overall survival and its associated 95 % CI will be derived, for each treatment arm, using the time to event analysis based on Kaplan-Meier methodology.|time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Days||95% Confidence Interval|Median
1218123|NCT00751036|Secondary|Time to Treatment Failure|TTF, defined as the time from date of randomization to the earliest of date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than ‘Protocol deviation’ or ‘Administrative problems’.|Time from date of radomization to the earliest date of the first objective tumor, death or discontinuation, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Days||95% Confidence Interval|Median
1218124|NCT00751036|Secondary|Disease Control Rate (DCR)|The Disease Control Rate (Complete Response(CR), Partial Response (PD) and Stable Disease (SD) rates for each treatment arm will be computed using the exact Clopper-Pearson interval estimation methodology. DCR is defined as the percentage of patients with a best overall response of • CR, i.e. at least two determinations of CR at least 4 weeks apart without loss of response between the determinations, • PR, i.e. at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) and without loss of PR between the determinations, or • SD lasting at least 24 weeks, i.e. at least one SD or better response at least 24 weeks after randomization (and not qualifying for CR or PR).|every 2 months until 24 months (end of study)|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Percentage of Patients||95% Confidence Interval|Number
1218136|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||Subjects|||Number
1218125|NCT00751036|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|24 months|Full Analysis Set (FAS) consisted of all randomized patients. Following the intent to treat principle, patients were analyzed according to the treatment which they were assigned at randomization.|||Days||95% Confidence Interval|Median
1218126|NCT00750919|Primary|Number of Participants Discontinuing Due to AEs|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 26 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Participants|||Number
1218127|NCT00750919|Primary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 30 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Participants|||Number
1218128|NCT00750919|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded for sleep diary question 5 how much time were you awake, after falling asleep initially as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
1218129|NCT00750919|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded for sleep diary question 3 how long did it take you to fall asleep’,  as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
1218130|NCT00750919|Primary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded for sleep diary question 6 how much time did you actually spend sleeping as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
1218131|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||Subjects|||Number
1218132|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||Subjects|||Number
1218133|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1218134|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1218135|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||Subjects|||Number
1218137|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1218138|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1218139|NCT00750893|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.|During the 8 day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1218140|NCT00750880|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit|FACIT-Fatigue is a 13-item questionnaire; participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1218141|NCT00750880|Secondary|Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit|The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of <0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of ≥0.22.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1218142|NCT00750880|Primary|Percentage of Participants With Adverse Events (AEs): Overall Summary|Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.|Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants included in the study who received at least 1 dose of study medication and who had at least 1 postbaseline assessment of safety (post-baseline laboratory data, vital signs, or adverse events). number (n) equals (=) number of participants analyzed for the parameter within the specific population.|||percentage of participants|||Number
1218143|NCT00750880|Secondary|Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1218144|NCT00750880|Secondary|HAQ-DI Scores by Visit|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1218145|NCT00750880|Secondary|Erythrocyte Sedimentation Rate by Visit|ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
1218146|NCT00750880|Secondary|C-Reactive Protein by Visit|The test for CRP (mg per deciliter [mg/dL]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1218147|NCT00750880|Secondary|Patient's Global Assessment of Pain by Visit|The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as “no pain” and the right-hand extreme=100 mm as “unbearable pain”. The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1218148|NCT00750880|Secondary|Physician's Global Assessment of Disease Activity by Visit|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as “maximum disease activity” (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1218149|NCT00750880|Secondary|Patient's Global Assessment of Disease Activity by Visit|The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as “maximum disease activity” (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1218150|NCT00750880|Secondary|Tender Joint Count by Visit|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the last observation carried forward (LOCF) approach.|||tender joints||Standard Deviation|Mean
1218151|NCT00750880|Secondary|Swollen Joint Count by Visit|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the LOCF approach.|||swollen joints||Standard Deviation|Mean
1218152|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.|Weeks 4, 8, 12, 16, 20, and 24|ITT population; only participants with a response (ACR20/ACR50/ACR70/ACR90) were included in the analysis. n=number of participants with a response for the specified parameter|||days||95% Confidence Interval|Median
1218153|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||participants|||Number
1218154|NCT00750880|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale [VAS]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||percentage of participants|||Number
1218155|NCT00750880|Secondary|DAS28 Scores by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1218156|NCT00750880|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. If the EULAR response could not be determined, it was set to 'No response'.|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||percentage of participants|||Number
1218157|NCT00750880|Secondary|Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event|The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 ≤3.2 and remission defined as DAS28 <2.6.|Baseline,Weeks 4, 8, 12, 16, 20, and 24|ITT population with DAS28 ≤3.2|||days||Full Range|Median
1218169|NCT00750373|Secondary|All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies||up to 6 months after enrollment|||||||
1218170|NCT00750373|Secondary|Recurrences of Infective Endocarditis||up to 6 months after enrollment|||||||
1218171|NCT00750373|Secondary|All-cause Death||up to 6 month after enrollment|||||||
1218158|NCT00750880|Secondary|Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 ≤3.2 and remission was defined as DAS28 <2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; Only population with complete DAS28 data were analyzed.|||participants|||Number
1218159|NCT00750880|Secondary|Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (≤)3.2 and remission was defined as DAS28 less than (<)2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; no imputation of missing data was performed for this analysis.|||percentage of participants|||Number
1218160|NCT00750867|Secondary|Preliminary Efficacy of IVIg for Treatment of MSA.|The secondary outcome measure was to evaluate the preliminary efficacy of IVIG for the treatment of MSA. The primary efficacy endpoint was change of the Unified MSA Rating Scale (UMSARS-I and UMSAR-II) compared to baseline. UMSARS-I and UMSARS-II are validated semiquantitative rating scales for evaluation of severity of MSA. UMSARS-I comprises a historical review of disease-related impairments and UMSARS-II comprises motor examination. UMSARS-I has 12 questions, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-I is 0 to 48. UMSARS-II has 12 items rated by an examiner, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-II is 0 to 56. The scores of UMSARS-I and UMSARS-II at baseline (month 1) was compared with the scores obtained at the final visit (month 8) which was 8 months apart. The interventions occured at months 2-7, total six times.|Monthly, up to 8 months (including the screening visit and the final visit)||||units on a scale||Standard Deviation|Mean
1218161|NCT00750867|Primary|Number of Adverse Events up to Six Months Post-treatment|The primary outcome measure was to evaluate the safety and tolerability of the IVIG infusions in patients with multiple system atrophy. The primary endpoint was defined as the frequency of adverse events (AE). AEs including their severity and relationship to the IVIG were assessed throughout the study and at least 60 days after the last infusion. The AEs were considered to be related to the IVIG infusion (infusional AE) if they occurred during an infusion or within 72 hours afterwards. Non-infusional AEs were further classified as possible related to IVIG or likely not related to IVIG. Serious AEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization. Any AE was defined as occurrence of any symptom regardless of intensity grade.|Monthly, up to 8 months (including the screening visit and the final visit)|Two participants dropped out from the study.|||Adverse events|||Number
1218162|NCT00750815|Secondary|Phase II: Two Year Overall Survival (OS)|Overall survival by disease risk stratification after CVDD. OS: time from initiation of therapy until death from any cause.|2 years|Participants with cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification.|||percentage of participants||95% Confidence Interval|Number
1218163|NCT00750815|Secondary|Phase II: Progression-Free Survival (PFS)|"Progression-free survival after CVDD in participants with newly diagnosed active multiple myeloma. PFS: time from the initiation of therapy to progression, relapse or death from any causes.~Progressive Disease (PD): Progressive Disease requires any one or more of the following:~Increase of ≥ 25% from baseline in:~serum M-component and /or (the absolute increase must be ≥ 0.5 g/dL)~urine M-component and/or (the absolute increase must be ≥ 200 mg/24 h)"|Up to 50.9 months||||months||95% Confidence Interval|Median
1218164|NCT00750815|Primary|Phase II: Overall Response Rate (ORR)|Best response to CVDD chemotherapy. Overall Response: Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR). PR: ≥ 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein with urine M-protein level < 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.|Up to 6 months|All Participants with Partial Response, Very Good Partial Response, or Complete Response.|||participants|||Number
1218165|NCT00750815|Primary|Phase I - Maximum Planned Dose (MPD) Level|"Maximum Phase II planned dose of cyclophosphamide when given in combination with bortezomib, pegylated liposomal doxorubicin and Dexamethasone (CVDD) in participants with newly diagnosed active multiple myeloma. Dose levels 1, 2, 3, 4 as outlined in Treatment Arm A.~If no dose limiting toxicity (DLT) was reported in the first 3 participants at a dose level, that dose level was to be considered safe and 3 participants would be enrolled at the next dose level. If 1/3 participants in a cohort at a dose level had dose limiting toxicity (DLT), the dose level would be expanded to obtain 6 evaluable participants. MPD reflects the highest dose of drug that did not cause a DLT in 33% of participants."|9 months|All participants in Arm A. Three participants at each dose level.|||Dosing Level|||Number
1218166|NCT00750737|Secondary|Efficacy Outcome Measured as Success or Failure|Success: Defined as the absence of proven or probable invasive fungal infection through the end of prophylaxis and absence of Grade 1-4 toxicity related to prophylaxis requiring the discontinuation of the drug. Failure: Presence of proven or probable fungal infection or development of Grade 1-4 toxicity related to prophylaxis while on study drug and requiring discontinuation of study drug or inability to tolerate intravenous ABLC (due to infusion related toxicities) or oral Posaconazole (due to mucositis or vomiting).|Day 1 through Day 42|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.|||percentage of participants|||Number
1218167|NCT00750737|Primary|Incidence of Invasive Fungal Infection (IFI)|Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).|Within 7 days of antifungal prophylaxis therapy|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.|||percentage of participants|||Number
1218168|NCT00750373|Secondary|Readmission Due to Development of Congestive Heart Failure||up to 6 months after enrollment|||||||
1218172|NCT00750373|Primary|Number of Participants With In-hospital Death or Clinical Embolic Events|The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.|within 6 weeks from the randomization|intention to treat analysis|||participants|||Number
1218173|NCT00750360|Secondary|Number of Participants Reporting Serious Adverse Events (SAE).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Within 1 month following vaccination||||participants|||Number
1218174|NCT00750360|Secondary|Number of Participant Reporting Unsolicited Adverse Events.|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day follow-up period (Day 0 to Day 20) after vaccination||||participants|||Number
1218175|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.||||participants|||Number
1218176|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.||||participants|||Number
1218177|NCT00750360|Primary|Number of Participants Reporting Severe Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities"|During the 21-day follow-up period (Day 0 to Day 20) after vaccination||||participants|||Number
1218178|NCT00750308|Primary|Insulin Sensitivity|As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm|three weeks|Those who completed protocol|||(mU/L)-1x(min)-1xL||Standard Error|Mean
1218179|NCT00750308|Primary|Beta Cell Function|Beta cell function as measured during a frequently sampled IV glucose tolerance test|3 hours||||microU/mM||Standard Error|Mean
1218180|NCT00750282|Secondary|Standard Uptake Value Ratios for Florbetaben Signal|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, lateral temporal cortex, parietal cortex, anterior cingulate, posterior cingulate cortex, occipital cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.)|90-110 min post injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||ratio||Standard Deviation|Mean
1218181|NCT00750282|Secondary|Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)|The agreement between 3 blinded readers concerning the visual assessment of abnormality of the brain scan (based on BAPL score) was measured by the kappa coefficient. Kappa values close to 1.0 indicate a high agreement while values close to 0 indicate random agreement.|45-60 min, 90-110 min, 110-130 min|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||Kappa coefficient|||Number
1218182|NCT00750282|Secondary|Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment|PET scans from two additional imaging windows (45-60 min and 110-130 min) were visually assessed|45 - 60 min and 110 - 130 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||percentage of subjects||95% Confidence Interval|Number
1218183|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth.|"Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores “2 or 3”) which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score “1) which was considered a match for specificity.~The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia.~Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media."|90 - 110 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||percentage of subjects||95% Confidence Interval|Number
1218184|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth|"Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis.~Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used.~Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of “1” (without beta-amyloid plaque load) or “2” (with minor beta-amyloid plaque load) was considered normal and a BAPL score of “3” (with significant beta-amyloid plaque load) was considered abnormal.~Using algorithm B (Average), a brain scan of a subject with a BAPL score of “1” was considered normal and a brain scan with a BAPL score of “2” or “3” was considered abnormal. Algorithm B was used in Part B and in the final"|90 - 110 min after investigational medical product (IMP) injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis.(n=146)|||percentage of subjects||95% Confidence Interval|Number
1218185|NCT00750269|Secondary|Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0|Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.|From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment who were observed more than 1 year after start of SBRT|||percentage of participants||95% Confidence Interval|Number
1218186|NCT00750269|Secondary|Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0|Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity.|From start of SBRT until 1 year.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1218187|NCT00750269|Secondary|Distant Metastases|Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1218188|NCT00750269|Secondary|Nodal Progression|Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of patients||95% Confidence Interval|Number
1218189|NCT00750269|Secondary|Local Progression|Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1218190|NCT00750269|Secondary|Overall Survival|An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1218191|NCT00750269|Secondary|Progression-free Survival|Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.|From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1218192|NCT00750269|Primary|(Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)|Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.|From start of SBRT to 2 years.|All eligible patients who started study treatment|||percentage of participants||90% Confidence Interval|Number
1218193|NCT00750269|Primary|(Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0|Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity <= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).|From start of SBRT to 1 year|All eligible patients who started study treatment|||Gy/FX|||Number
1218194|NCT00750204|Primary|Amount of Sedatives Used||48 hours|Data was not collected for this outcome measure, as the study was terminated prematurely.||||||
1218199|NCT00750152|Secondary|Mycological Cure and Treatment Effectiveness|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.|Week 4 (two weeks post-treatment)|This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.|||percentage of subjects|||Number
1218200|NCT00750152|Primary|Percentage of Subjects|Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.|Week 4 post-baseline|The Full Analysis Set (FAS)is the subset of all subjects in the Safety Evaluation Set (SES)with a positive culture at baseline and for whom the primary efficacy variable is available. This is a modified intent-to-treat (MITT) principle because the culture results were not available before the start of treatment.|||percentage of subjects with complete cur|||Number
1218201|NCT00750139|Secondary|Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.|Week 6|This was the Full Analysis Set (FAS) comprising of subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable was available. This was a Modified Intent to Treat (MITT) principle because the culture results were not available at the start of treatment.|||percentage of Subjects|||Number
1218202|NCT00750139|Primary|Percentage of Subjects With Complete Cure at Week 6.|"The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6.~The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6.~Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale."|Week 6|This is based on the Full Analysis Set (FAS). The FAS is the subset of all subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable is available. This is a modified intent to treat (MITT) principle because the culture results will not be available before the start of treatment.|||percentage of subjects with complete cur|||Number
1218203|NCT00750061|Secondary|Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain|Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 ~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 ~ 100, the less the better)|6 months|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1218204|NCT00750061|Primary|Changes of Neurological Scores for Baseline|Changes of Motor Scores (0 ~ 100), Pin Prick Scores (0 ~ 112) and Light Touch Scores (0 ~ 112) from Baseline to Week 6 and Month 6. The higher the changes the better the functional improvement.|6 months|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1218205|NCT00749996|Secondary|To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).|"The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI).~The ODI is a low back pain disability questionnaire used to measure a patient’s permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability."|12 Months||||patient's score||Standard Deviation|Mean
1218206|NCT00749996|Primary|To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).|The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning ‘no pain’ and 10cm meaning ‘worst possible pain’) will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.|6 Months||||units on a scale||Standard Deviation|Mean
1218207|NCT00749957|Secondary|Participants With Changes in Best Corrected Visual Acuity|Increase in BCVA of 7 or more letters at Year 2 visit compared to average baseline value|2 years||||participants|||Number
1218208|NCT00749957|Secondary|Participants With Changes in Visual Fields|Improvement in the central 30 degree visual field, measured by static perimetry, at one or more time points after treatment, that was greater than the limit of agreement for baseline values .|2 years||||participants|||Number
1218209|NCT00749957|Primary|Number of Participants Experiencing Ocular or Non-ocular Adverse Events||2 years||||participants|||Number
1218210|NCT00749944|Secondary|Change From Baseline in the Number of Cigarettes Smoked Per Day||Baseline (Week 0) to Week 2|FAS; (n)=number of subjects with at least 1 dose of study drug and an observation for a given day.|||cigarettes smoked per day||Standard Deviation|Mean
1218211|NCT00749944|Secondary|Number of Participants With 7-day Point Prevalence of Abstinence (Smoking Cessation)|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (during treatment) in the previous 7 days and who did not have carbon monoxide of more than 10 parts per million for that observation (if measured).|Week 5 to Week 13|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1218212|NCT00749944|Secondary|Number of Participants With Carbon Monoxide Confirmed Daily Smoking Cessation|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory, which was used to collect the information of cigarette or other nicotine use during the study) and who did not have carbon monoxide of more than 10 parts per million at any time from Week 9 to Week 12|Week 9 to Week 12|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1218213|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Social Dysfunction and Aggression Scale (SDAS): Total Score|SDAS total scores ranged from 0 (not present) to 44 (extremely severe). Participants exceeding the threshold had a SDAS total score of more than 6 out of 44.|Baseline B (Week 2) to Week 4 (Period BC)|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1218214|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Barratt Impulsiveness Scale – Version 11 (BIS-11): Total Score|The BIS-11 is designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Total score ranged from 30 (less impulsive) to 120 (more impulsive). Participants exceeding the threshold had a BIS-11 total score more than or equal to 70 out of 120. BIS-11 total scores of more than or equal to 70 could reflect clinically important and potentially pathological impulsivity.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1218215|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Suicidality total score ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency). No threshold criterion was determined for OAS-m Suicidality total score.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|The number of participants above the threshold for the OAS-m Suicidality total score was not analyzed as the majority of observations were recorded as 0.|||participants|||Number
1218216|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Irritability total score ranged from 0 (no irritability) to 10 (extreme irritability). Participants exceeding the threshold had an OAS-m Irritability total score of more than or equal to 2 out of 10. OAS-m Irritability total scores of more than or equal to 2 reflect clinically important irritability.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1218217|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Agression Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Aggression total score ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week. Participants exceeding the threshold had an OAS-m Aggression total score of more than or equal to 3 out of any number with no upper limit depending on the frequency of agressive behaviour in a week. OAS-m Aggression total scores of more than or equal to 3 reflect clinically important aggression.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1218218|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms. Total scores ranged from 0 (not affected) to 56 (very severely affected). Participants exceeding the threshold had a HAM-A total score of more than or equal to 14 out of 56. HAM-A total scores of more than or equal to 14 may reflect clinically noteworthy levels of anxiety.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1218219|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms. Total score ranged from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Participants exceeding the threshold had a MADRS total score of more than 14 out of 60. MADRS total scores exceeding 14 may represent clinically notable effective symptomatology.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively. Statistical analyses were not performed for Period AB due to the small number of participants exceeding the threshold.|||participants|||Number
1218220|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Profile of Mood States (POMS): Total Score|POMS total mood disturbance (TMD) summary results were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). Participants exceeding the threshold had an increase from baseline of 1 standard deviation of the TMD baseline T-score plus 1 or more.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1218221|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Increased Appetite Subscale|The MNWS increased appetite subscale contains 1 item (increased appetite) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no increased appetite) to 4 (extreme increased appetite).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218313|NCT00748956|Secondary|Systematic Assessment of Treatment-Emergent Effects (SAFTEE)|Number of participants with serious adverse events|on study day 2||||Participants|||Count of Participants
1218314|NCT00748956|Primary|Levels of NPY in CSF|Levels of Neuropeptide Y in the cerebrospinal fluid|on study day 2||||pg/mL||Standard Deviation|Mean
1218222|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Restlessness Subscale|The MNWS restlessness subscale contains 1 item (restlessness) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no restlessness) to 4 (extreme restlessness).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218223|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Urge to Smoke Subscale|The MNWS urge to smoke subscale contains 1 item (urge to smoke) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no urge to smoke) to 4 (extreme urge to smoke).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218224|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Insomnia Domain Subscale|The MNWS insomnia domain subscale contains 2 items (difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average of the 2 items and ranged from 0 (no insomnia) to 4 (extreme insomnia).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218225|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Negative Affect Domain Subscale|The MNWS negative affect domain subscale contains 4 items (depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average from all 4 items and ranged from 0 (no negative affect) to 4 (extreme negative affect).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218226|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Total Score|The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Total scores were the average score for all 9 items and ranged from 0 (no withdrawal symptoms) to 4 (extreme withdrawal symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218227|NCT00749944|Primary|Change From Baseline in the Barratt Impulsiveness Scale – Version 11 (BIS-11): Total Score|The BIS-11 is a 30-item self-report questionnaire designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Possible responses to each item were: 1=rarely/never, 2=occasionally, 3=often, and 4=almost always/always. Scores of Items 1, 7, 8, 9, 10, 12, 13, 15, 20, 29 and 30 were reversed when calculating the total score. Total score ranged from 30 (less impulsive) to 120 (more impulsive).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218228|NCT00749944|Primary|Change From Baseline in the Social Dysfunction and Aggression Scale (SDAS): Total Score|The SDAS contains 11 items with 5 possible responses: 0=not present, 1=doubtful or very mild, 2=mild to moderate, 3=severe, and 4=extremely severe. The SDAS was collected 3 times a day during the inpatient abstinence period (BC). Total scores ranged from 0 (not present) to 44 (extremely severe).|Baseline B (Week 2) to Week 4 (Period BC)|No change from baseline analysis was performed on the SDAS total score as the majority of observations were recorded as 0.|||scores on a scale||Standard Error|Least Squares Mean
1218229|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Suicidality total score was calculated by summing the items Q7 to 7b. Scores for Q7 ranged from 0 (none) to 6 (very extreme) and scores for Q7a to 7b ranged from 0 (none) to 5 (extreme). Total scores ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|No change from baseline analysis was performed on the OAS-m Suicidality total score as the majority of observations were recorded as 0.|||scores on a scale||Standard Error|Least Squares Mean
1218230|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Irritability total score was calculated by summing the items in Q5 to 6. Scores for each question ranged from 0 (not at all) to 5 (extreme). Total scores ranged from 0 (no irritability) to 10 (extreme irritability).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218315|NCT00748865|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,|once upon instillation||||Units on a scale||Standard Deviation|Median
1218231|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Aggression Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Aggression total score was calculated by summing the weighted scores in Q1 to 4. Scores for each question ranged from 0 (no events) to 5 (very severe events). Total scores ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218232|NCT00749944|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms and is a 14-item questionnaire. Each item was scored from 0 (not present) to 4 (very severe) and a lower score indicated less affected. Total scores ranged from 0 (not affected) to 56 (very severely affected).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218233|NCT00749944|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms and is a 10-item checklist. Each item was rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218234|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Confusion Subscale|POMS Confusion subscale data were responses to 7 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Efficient. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218235|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Fatigue Subscale|POMS Fatigue subscale data were responses to 7 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218236|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Vigor Subscale|POMS Vigor subscale data were responses to 8 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218237|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Anger-Hostility Subscale|POMS Anger-Hostility subscale data were responses to 12 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218238|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Depression-Dejection Subscale|POMS Depression-Dejection subscale data responses to 15 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218239|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Tension-Anxiety Subscale|POMS Tension-Anxiety subscale data were responses to 9 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Relaxed. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218367|NCT00748540|Primary|Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge|Percent correct on words in quiet at the preoperative interval compared to 6 month post operative interval.|6 months post initial activation||||percentage of words correct||Standard Deviation|Mean
1218240|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD)|POMS TMD were responses to 65 items in 6 subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor, Fatigue, and Confusion), on ‘How you feel right now?’ (scale:0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for Relaxed and Efficient in the Tension-Anxiety and Confusion subscales. TMD was the sum of the scores of all 6 subscales but weighting Vigor negatively. Summary results (TMD scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|Full analysis set (FAS): All randomized subjects with at least 1 dose of study drug and at least 1 post-baseline neuropsychiatric evaluation or Minnesota Nicotine Withdrawal Scale (MNWS) obtained; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1218241|NCT00749931|Post-Hoc|Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens||Up to 2 months post-surgery||||percentage of participants|||Number
1218242|NCT00749931|Primary|The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.|Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively|two weeks after surgery|"The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen (PSS – Positive specimen subjects)"|||percentage of participants analyzed|||Number
1218243|NCT00749775|Secondary|Number of Participants That Responded to Selara Treatment.|Number of participants among the efficacy analysis population that responded to Selara treatment.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||participants|||Number
1218244|NCT00749775|Secondary|Change in Diastolic Blood Pressure Over Time.|The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||mmHg||Standard Deviation|Mean
1218245|NCT00749775|Secondary|Change in Systolic Blood Pressure Over Time.|The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||mmHg||Standard Deviation|Mean
1218246|NCT00749775|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.|12 weeks|No statistical analysis provided for the frequency of serious treatment related adverse events.|||participants|||Number
1218247|NCT00749775|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.|12 weeks|No statistical analysis provided for the frequency of Treatment Related adverse events.|||participants|||Number
1218248|NCT00749684|Primary|Relapse Free Survival Time|Median time to recurrence according to Kaplan Maier evaluation|Throughout 12 months of treatment and 24 months of follow-up||||months||Full Range|Median
1218249|NCT00749684|Primary|Number of Participants With Disease Recurrence|Number of participants with disease recurrence was being measured.|Throughout 12 months of treatment and 24 months of follow-up|138 participants with malignant melanoma, 88 male participants and 50 female participants were evaluated.|||participants|||Number
1218250|NCT00749671|Secondary|Patient Recall of Defibrillation Testing|The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.|30 minutes||||percentage of patients with DFT recall|||Number
1218251|NCT00749671|Primary|Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes|"Sedation level was evaluated and graded according to the observer's assessment of alertness/sedation (OAAS) rating scale. This scale has 6 possible measures of consciousness:~OAAS score 5—awake and responds readily to name spoken in normal tone.~OAAS score 4—lethargic responses to name in normal tone.~OAAS score 3—responds only after name is called loudly and/or repeatedly.~OAAS score 2—responds only after name called loudly and mild shaking.~OAAS score 1—does not respond when name is called loudly and mild shaking or prodding.~OAAS score 0—does not respond to noxious stimulation."|30 minutes||||units on a scale||95% Confidence Interval|Mean
1218252|NCT00749606|Secondary|International Physical Activity Questionnaire|Measure of physical activity is calculated as in mets/week|baseline, 6 months, 1 and 2 years||||mets per week||Standard Error|Mean
1218253|NCT00749606|Secondary|SF-12 Physical Summary Score|The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).|baseline, 6 months, 1 and 2 years||||units on a scale||Standard Error|Mean
1218254|NCT00749606|Secondary|Health Behaviors (Diet, Physical Activity)|National Cancer Institute Fat screener|baseline, 6 months, 1 and 2 years||||percentage of daily calories from fat||Standard Error|Mean
1218255|NCT00749606|Secondary|Fasting Glucose Level|Fasting glucose (mg/dL)|baseline, 1, 2, 3 years||||mg/dL||Standard Deviation|Mean
1218256|NCT00749606|Secondary|Fasting Lipid Panel|LDL-cholesterol (mg/dL)|baseline, 1, 2, 3 years|Note: LDL-cholesterol measurements were not available for 13 participants in the Individual Call arm and 6 participants in the Conference Call arm|||mg/dL||Standard Deviation|Mean
1218257|NCT00749606|Secondary|Blood Pressure|Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)|baseline, 1, 2, 3 years||||mmHg||Standard Deviation|Mean
1218261|NCT00749476|Primary|Number of Participants Reporting Efficacy|Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion.|4 months|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||Participants|||Number
1218262|NCT00749463|Secondary|Point Prevalence Smoking Abstinence (PPSA)|Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment.|24 Weeks||||Participants|||Number
1218263|NCT00749463|Primary|Smoking Abstinence|Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day|24 Weeks||||Participants|||Number
1218264|NCT00749463|Secondary|Smoking Consumption Per Week|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)|24 Weeks from last visit:||||Cigarettes||Standard Deviation|Mean
1218265|NCT00749463|Secondary|Smoking Consumption Per Day|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)|24 Weeks from last visit:||||Cigarettes||Standard Deviation|Mean
1218266|NCT00749463|Secondary|Carbon Monoxide (CO)-Verified Smoking Reduction|Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)|Baseline to Week 24||||Percentage of Participants||Standard Deviation|Mean
1218267|NCT00749463|Primary|Self-Reported Smoking Reduction|Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day|24 Weeks||||Percentage of Participants||Standard Deviation|Mean
1218268|NCT00749463|Primary|Treatment-Related Adverse Events|Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher|24 Weeks|Safety Analysis Set (ITT)|||Percentage of Participants|||Number
1218269|NCT00749398|Secondary|Number of Participants With Satisfactory Health Status|"Participant's opinion on his/her health status, as assessed by the following question: Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)"|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Participants|||Number
1218270|NCT00749398|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218271|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Participant|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218272|NCT00749398|Secondary|Static PGA Score as Assessed by the Participant|Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218273|NCT00749398|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218274|NCT00749398|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218275|NCT00749398|Secondary|Percent Body Surface Area (BSA) Involved With Psoriasis||Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)|Per protocol analysis.|||Percent BSA Involved with Psoriasis||Standard Deviation|Mean
1218276|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Investigator|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218277|NCT00749398|Primary|Dynamic Photographic PGA Score as Assessed by Two Dermatologists|The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218278|NCT00749398|Secondary|Static PGA Score as Assessed by the Investigator|Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218279|NCT00749398|Primary|Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists|Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1218280|NCT00749268|Secondary|Hernia Recurrence||Discharge, 1 Month, 6 Month, 1 year||||participants|||Number
1218281|NCT00749268|Secondary|Quality of Life|"Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.~The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Pre-op, Month 1, Month 6, 1 year|Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively.|||units on a scale||Standard Deviation|Mean
1218282|NCT00749268|Primary|Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events||One year||||participants|||Number
1218283|NCT00749268|Primary|Postoperative Pain|"Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.~Scale is 0 - 10 with 0 being no pain and 10 being worst pain imaginable."|Discharge, Month 1, Month 6, Month 12|1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis.|||units on a scale||Standard Deviation|Mean
1218284|NCT00749203|Secondary|Hopkins Verbal Learning Test (HVLT)|Repeatable test of memory acquisition and delayed recall of words. It is a three-trial list learning and free recall task comprising 12 words, 4 words from each of three semantic categories. Total Recall score range is 0 to 36.|20 to 40 minutes after infusion|data not collected||||||
1218285|NCT00749203|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|Clinician-administered questionnaire measuring depressive symptoms. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). Mean difference between baseline and 2 weeks.|24 hours after first infusion||||units on a scale||Standard Deviation|Mean
1218286|NCT00749203|Secondary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|Self-report questionnaire measuring depressive symptoms. Each item is rated 0 (no depression) to 3 (severe depression). The total score ranges from 0-27.|24 hours after first infusion||||units on a scale||Standard Deviation|Mean
1218287|NCT00749203|Secondary|Clinician-Administered PTSD Scale (CAPS)|Clinician-administered structured interview measuring PTSD symptoms. frequency score - scale 0 = none of the time to 4 = most or all of the time intensity score - scale 0 = none to 4 = extreme To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. 30 questions scale, with total score ranging from 0 to 240.|7 days after first infusion|Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.|||units on a scale||Standard Deviation|Mean
1218288|NCT00749203|Primary|Impact of Event Scale - Revised (IES-R)|"A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely)"|7 days after first infusion|Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.|||units on a scale||Standard Deviation|Mean
1218289|NCT00749190|Secondary|Trough Concentrations of Empagliflozin in Plasma|(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1218290|NCT00749190|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||kg||Standard Error|Mean
1218291|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU / mmol||Standard Error|Mean
1218292|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L x mmol/L||Standard Error|Mean
1218293|NCT00749190|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA|Baseline and 12 weeks|FAS (CLOCF)|||mU/L||Standard Error|Mean
1218294|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)|||percentage of participants|||Number
1218295|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)|||percentage of participants|||Number
1218296|NCT00749190|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS. Imputation method used was the classical LOCF (CLOCF) approach which uses always the last available value.|||percentage of HbA1c||Standard Error|Mean
1218660|NCT00745368|Primary|Female Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
1218297|NCT00749190|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.~In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|FAS using modified LOCF imputation method|||mg/dL||Standard Error|Mean
1218298|NCT00749190|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment|"Change from baseline in HbA1c after 12 weeks of treatment.~In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|Full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug and has a baseline measurement of the primary endpoint. The imputation method used was a modified last observation carried forward (LOCF) approach which used linear interpolation, LOCF and worst observation carried forward (WOCF).|||percentage of HbA1c||Standard Error|Mean
1218299|NCT00749125|Primary|Activations in Different Cortical Regions Caused by Emotionally Evocative Task|MRI scans from 41 participants (23 depressed and 18 controls), including fMRI scans using an emotional distractor task, were analyzed for differences between groups in activation in a priori regions (amygdala and DLPFC), measured with BOLD signal, for two conditions of the task - attend fearful and ignore fearful, both at baseline and following 8 weeks of treatment for the depressed group. Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions. Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region. We expect more positive values (greater activation) in depressed participants at baseline than in controls during the attend fearful task, and more negative values (greater de-activation) in controls at baseline than depressed during the ignore fearful task. These differences were expected to lessen significantly following treatment in the depressed group.|baseline and week 8|23 patients with major depression were matched with 18 demographically similar healthy controls. Depressed subjects were treated with Lexapro 10 mg/day, initiated immediately following the first fMRI scan.|||Voxels||Standard Deviation|Mean
1218300|NCT00749073|Primary|Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.|The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Six months|All available treated patients with six month follow-up.|||units on a scale||95% Confidence Interval|Mean
1218301|NCT00749073|Primary|Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire|Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.|Baseline and Month 6|All treated patients having six month follow-up were included.|||units on a scale||Standard Deviation|Mean
1218302|NCT00749073|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at six months post treatment. Mean change from baseline to Month 6 was reported.|||units on a scale||Standard Deviation|Mean
1218303|NCT00748982|Secondary|QTcF Interval|Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula|Up to 24 hours following start of IV dosing.||||ms||95% Confidence Interval|Mean
1218304|NCT00748982|Secondary|Area Under Curve (AUC) ( µmol*h/L) of AZD1305|To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.||||µmol*h/L||Full Range|Mean
1218305|NCT00748982|Secondary|Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group|To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.|From randomisation to last study visit (mean infusion time 1.6 hours)||||Participants|||Number
1218306|NCT00748982|Primary|Left Ventricular Ejection Fraction (LVEF), Change From Baseline|To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out||||Percent change||95% Confidence Interval|Mean
1218307|NCT00748969|Secondary|Safety: Number Drug Related SAEs||1 months|Study stopped early due to inability to enroll participants.|||Participants|||Count of Participants
1218308|NCT00748969|Primary|Change in Growth Velocity From Baseline to End of Study Year 1.||12 months|"Zero participants analyzed in the No growth hormone treatment group due to subject withdrew from study as soon as informed they were assigned the no treatment group."|||cm/yr|||Number
1218309|NCT00748956|Secondary|Profile of Mood States (POMS)|measure in 2 hours post intranasal administration and on the next morning|on study day 2|data not collected||||||
1218310|NCT00748956|Secondary|Quick Inventory of Depressive Symptoms (QIDS)|measure in 2 hours post intranasal administration|on study day 2|data not collected||||||
1218316|NCT00748826|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised of a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participant|||Number
1218317|NCT00748826|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the In-vitro TB test (cellular blood test, i.e. gamma interferon release assays) per clinical testing as the first screening test was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
1218318|NCT00748826|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (Multiple puncture Tuberculin skin test) per clinical testing as the first screening test was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
1218319|NCT00748826|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (Tuberculin sensitivity skin test by intradermal injection) per clinical testing as the first screening test was presented in~three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
1218320|NCT00748709|Secondary|Number of Patients With Diarrhea or Rash|Number of Patients with Diarrhea or Rash|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
1218321|NCT00748709|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15 for patients on 50mg on day 15.|Day 15||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1218322|NCT00748709|Primary|Percentage of Participants With Objective Response (OR)|OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.|||percentage of patients|||Number
1218323|NCT00748709|Secondary|Maximum CTCAE Grade|Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
1218324|NCT00748709|Secondary|Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation|Patients with adverse events (AEs) resulting in dose reduction or treatment discontinuation|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
1218325|NCT00748709|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the start of treatment to the occurrence of disease progression or death, whichever came first. Disease progression was assessed according to RECIST 1.0 criteria as well as by the investigators assessment, progression date recorded from post trial follow up or start of new anticancer treatment.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for PFS.||||||
1218326|NCT00748709|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for duration of OR.||||||
1218327|NCT00748709|Secondary|Time to Objective Response (OR)|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|Trial terminated early, therefore no data summaries produced for time to OR.||||||
1218328|NCT00748709|Secondary|Percentage of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|TS.|||percentage of patients|||Number
1218329|NCT00748657|Secondary|Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0|Adverse Events at least possibly related to study agent.|Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
1218330|NCT00748657|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||Months||95% Confidence Interval|Median
1218661|NCT00745368|Primary|Male Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
1218331|NCT00748657|Secondary|Progression-free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
1218332|NCT00748657|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients|||percentage of patients||90% Confidence Interval|Number
1218333|NCT00748579|Secondary|Effects of CK-1827452 on Ventricular Performance, Myocardial Oxygen Consumption, Pressure-volume Relationships, Systolic Ejection Time and Invasively Measured Hemodynamics, Including Filling Pressures and Cardiac Output.||1 day|||||||
1218334|NCT00748579|Primary|Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.|Measure the effect CK-1827452 on hemodynamics and energetic measures of ventricular performance, myocardial oxygen consumption, and myocardial efficiency (the ratio of ventricular performance to myocardial oxygen consumption), in patients with clinical heart failure.|1 day|Study was terminated due to poor enrollment; 2 participants completed the study. Data quantity was insufficient to analyze or draw conclusions.||||||
1218335|NCT00748566|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior(3)(“Yes” on “preparatory acts or behavior”), suicidal ideation(4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(“Yes” on “Has subject engaged in non-suicidal self-injurious behavior”).|Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1218336|NCT00748566|Secondary|Changes From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1218337|NCT00748566|Secondary|Change From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Index (EQ-I) Score at Week 28 and 52|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1218338|NCT00748566|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52|SOFAS: a 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1218339|NCT00748566|Secondary|Change From Baseline in Drug-Attitude Inventory–30-Item Scale (DAI-30) Score at Week 28 and 52|DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1218340|NCT00748566|Secondary|Clinical Global Impression-Improvement (CGI-I) Scale Score|CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse.|Endpoint (premature discontinuation or Week 52)|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1218341|NCT00748566|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52|CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants).|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1218662|NCT00745368|Primary|Raltegravir Female Genital Tract Concentration||8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
1218342|NCT00748566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52|Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity.|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1218343|NCT00748566|Secondary|Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds (60 divided by heart rate).|Baseline, Week 4, 12, 28, 52|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure. Missing values at Week 52 were imputed using LOCF. N (number of participants analyzed)=participants evaluable for this measure. n=evaluable participants at specified time points.|||milliseconds||Standard Deviation|Mean
1218344|NCT00748566|Secondary|Change From Baseline in the Physical Activity Index Score at Week 28 and 52|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (>=21). Higher total score = higher frequency and intensity of physical activity.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1218345|NCT00748566|Secondary|Change From Baseline in Insulin Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values were imputed using LOCF at Week 52. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||international unit per liter (IU/L)||Standard Deviation|Mean
1218346|NCT00748566|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of total hemoglobin||Standard Deviation|Mean
1218347|NCT00748566|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52|Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 .|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||kg/m^2||Standard Deviation|Mean
1218348|NCT00748566|Secondary|Change From Baseline in Weight at Week 4,12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||kilogram (kg)||Standard Deviation|Mean
1218349|NCT00748566|Secondary|Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mmol/L||Standard Deviation|Mean
1218350|NCT00748566|Secondary|Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to >=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from <1% to >=30%, where higher percent indicates greater risk for CHD.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||percent of 10-year CHD risk||Standard Deviation|Mean
1218351|NCT00748566|Secondary|Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mg/dL||Standard Deviation|Mean
1218352|NCT00748566|Secondary|Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52|Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mg/dL||Standard Deviation|Mean
1218353|NCT00748566|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52|BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mmHg||Standard Deviation|Mean
1218354|NCT00748566|Secondary|Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52|Waist circumference data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||cm||Standard Deviation|Mean
1218355|NCT00748566|Secondary|Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of participants||95% Confidence Interval|Number
1218356|NCT00748566|Secondary|Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||participants|||Number
1218357|NCT00748566|Secondary|Percentage of Participants With Metabolic Syndrome (MS)|According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of participants||95% Confidence Interval|Number
1218358|NCT00748566|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: greater than or equal to (>=)102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (<)1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||risk factors||Standard Deviation|Mean
1218359|NCT00748566|Primary|Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)|MS risks factors: elevated (el) waist, men:>=102 centimeters(cm), women:>=88 cm (Asian origin:>=90 cm in men, >=80 cm in women); el triglycerides: >=1.7 millimoles per liter (mmol/L) (>=150 milligram per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C), men:<1.03 mmol/L (<40 mg/dL), women:<1.3 mmol/L (<50 mg/dL); el fasting glucose: >=5.6 mmol/L (>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP>=130 millimeters of mercury (mmHg) and/or DBP>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.|Endpoint (premature discontinuation or Week 52)|Per protocol (PP) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure, and remained in the study for at least 16 weeks. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants||95% Confidence Interval|Number
1218360|NCT00748553|Secondary|Progression-free Survival|Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse.|2 years|Data were not collected.||||||
1218361|NCT00748553|Secondary|Number of Participants With ER+ Status|Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days).|2 years|Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity. Thirteen patients were evaluated for ER+ status.|||participants were ER+|||Number
1218362|NCT00748553|Primary|Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria|"Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized.~For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1.5 years|Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity.|||percentage of participants||95% Confidence Interval|Number
1218363|NCT00748553|Primary|Phase I: Percentage of Participants Responding to Treatment|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.|6 months|16 patients were evaluable for toxicity. 13 were evaluable for response per RECIST v1.|||percent of participants with response||95% Confidence Interval|Number
1218364|NCT00748540|Secondary|Residual Hearing in Patients Implanted With Vibrant Soundbridge|Unaided hearing thresholds measured at the 10 month interval compared to the preoperative interval in order to assess any changes|10 months post initial activation||||Participants|||Count of Participants
1218365|NCT00748540|Secondary|Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.|Signal to Noise Ratio for sentences at the preoperative interval compared to the 6 month interval.|6 months post initial activation|3 subjects did not completed this testing due to limitations of the equipment used.|||Signal to Noise Ratio||Standard Deviation|Mean
1218366|NCT00748540|Secondary|Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.|Auditory thresholds in the soundfield at the preoperative interval compared to the 6 month postoperative interval.|6 months post initial activation||||Participants|||Count of Participants
1218368|NCT00748410|Secondary|Amount of Medicine in Blood|Blood samples were collected at 1, 2.25, 4, 8 hour on Day 1 and 7 for the analysis of amount of medicine in blood. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|At 1, 2.25, 4, 8 hour on Day 1 and 7|All subjects population.|||nanogram per hour (ng/hr)|||Number
1218369|NCT00748410|Secondary|Changes From Baseline to After Treatment in Faecal Calprotectin Levels|Stool sample was collected from 1-hour post dose until 8 hours post dose for faecal calprotectin measures. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.|Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7|All subjects population.|||milligram per litre (mg/L)|||Number
1218370|NCT00748410|Secondary|Vital Signs Assessment- Heart Rate|Vital sign measurements included heart rate at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|Day 1 and 7|All subjects population. Only those participants with data available at the specified time points were analyzed.|||beats per minute (bpm)|||Number
1218371|NCT00748410|Secondary|Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements included SBP and DBP at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|Day 1 and 7|All subject population. Only those participants with data available at the specified time points were analyzed.|||millimeter of mercury (mmHg)|||Number
1218372|NCT00748410|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to follow-up (7 to 10 days after last dose)|All subject population.|||Participants|||Count of Participants
1218373|NCT00748410|Primary|Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)|Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.|Baseline (Day -1) and Day 1 and 7|The ‘All Subjects population’ was defined as all participants who received at least one dose of study medication. Only those participants with data available at the specified time points were analyzed.|||Score on scale|||Number
1218374|NCT00748241|Secondary|Implant Failure|Total number of implants reported as failure.|3 years after implant placement|Number of failed implants based on total number of patients enrolled and total number of placed implants|||Number of implants|Participants||Number
1218375|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 3 years after implants have been loaded|Population includes subjects who completed 36 month visit.|||Percentage of implants|Participants||Number
1218376|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 2 years after implants have been loaded|Population includes subjects who completed 24 month visit.|||Percentage of implants|Participants||Number
1218377|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 1 year after implants have been loaded|Population includes subjects who completed 12 month visit.|||Percentage of implants|Participants||Number
1218378|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 6 months after implants have been loaded|Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).|||Percentage of implants|Participants||Number
1218439|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode (Outcome Measure Percentage of patients healed. Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After two weeks||||percentage of patients|||Number
1218379|NCT00748189|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Gram per liter||Standard Deviation|Mean
1218380|NCT00748189|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1218381|NCT00748189|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1218382|NCT00748189|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented by treatment cycle. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1218383|NCT00748189|Secondary|Number of Participants With AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1218384|NCT00748189|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1218385|NCT00748189|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL)|HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTCQLQC30), Chronic Lymphocytic Leukemia module (EORTC QLQ-CLL16), EuorQoL-Five Dimension (EQ-5D), and HCQ. Period (P)1 (Day 85, Day 169, Day 253) and P2 (scheduled follow-up (FU) and withdrawal visits) analysis were considered. Baseline (BL) for P1 was defined as score from screening visit and BL for P2 was defined as the last on-treatment score. The 2 principal QoL outcomes were pre-specified as the Global Health scale (GHS/QOL) of the EORTC QLQ-C30 and fatigue scale of the EORTC QLQ-CLL16. For EORTC QLQ-C30,GHS/Qol, the possible scale range was 0-100 (with 100 being 'best') and a positive difference from BL is indicative of better functioning (range -100 to +100). For the EORTC QLQ-CLL16 fatigue scale, the possible scale range was 0-100 (with 0 being 'best') and a negative difference from BL represents an improvement in fatigue (range -100 to +100).|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
1218386|NCT00748189|Secondary|Dose-normalized AUC(0-6) and AUC(0-inf) of Chlorambucil and Dose-normalized AUC(0-6) of Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The area under the plasma concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) and over 6 hours (AUC[0-6]) of chlorambucil and AUC(0-6) of PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.|||Hours*nanogram/milliliter/milligram||Standard Deviation|Geometric Mean
1218663|NCT00745368|Primary|Raltegravir Male Genital Tract Concentration||8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
1218387|NCT00748189|Secondary|Dose-normalized Cmax of Chlorambucil and Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The maximum observed concentration (Cmax) of chlorambucil and PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.|||nanograms per milliliter per milligram||Standard Deviation|Geometric Mean
1218388|NCT00748189|Secondary|Plasma Half Life (t1/2) of Ofatumumab|The terminal half-life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original concentration. Blood samples were collected to assess the plasma half-life of ofatumumab. Blood samples were collected from participants who received ofatumumab plus chlorambucil pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population|||hours||Geometric Coefficient of Variation|Geometric Mean
1218389|NCT00748189|Secondary|Vss of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Blood samples were collected from participants who received ofatumumab plus chlorambucil at predose and 0.5 hour after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."|||Liters||Geometric Coefficient of Variation|Geometric Mean
1218390|NCT00748189|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval [AUC(0-tau)] is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the ofatumumab plasma concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of ofatumumab. For estimation of AUC(0-tau), blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hous after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."|||µg x hours/mL||Geometric Coefficient of Variation|Geometric Mean
1218391|NCT00748189|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population.|||Milliliter/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1218392|NCT00748189|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of treatment.|Cycle 1 Day 1,Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, and Cycle 9 Day 1|Pharmacokinetic (PK) Population: all participants for whom a pharmacokinetic sample was obtained and analyzed.|||Micrograms/Milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1218393|NCT00748189|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result|Serum samples for analysis of HAHA were collected at Baseline (Screening), Cycle 4 Day 1 (after 3 months of treatment), and at 1 month and 6 months post last dose of ofatumumab. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive and further evaluated in the titration test to obtain a titer of HAHA.|Baseline, Cycle 4 Day 1, 1 Month Follow-up, and 6 Month Follow-up|Safety population: all participants who received at least 1 dose of a study drug. Only participants with post-ofatumumab HAHA Results are included.|||Participants|||Number
1218394|NCT00748189|Secondary|Number of Participants With Improvement in Constitutional Symptoms (CS)|Assessment for the presence of the following symptoms were performed at Screening, Day 1 of each treatment cycle and at every Follow-up visit: night sweats (without signs of infection); unexplained, unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of greater than 38 degrees celsius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue. The best response refers to overall best response in terms of CR, CRi, PR or nPR. Data are presented for constitutional response= yes and no.|Baseline, Cycle 3 Day 1, and 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1218664|NCT00745290|Secondary|Number of Participants With Adverse Events Through 96 Hours and Serious Adverse Events Through 30 Days||through 30 days|||||||
1218395|NCT00748189|Secondary|Number of Participants With Improvement in ECOG Performance Status of 0 or 1, as Assessed by the IRC|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead. Participants with an ECOG performance status of 0 or 1 are shown..|Baseline, Cycle 3 Day 1, 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1218396|NCT00748189|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
1218397|NCT00748189|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
1218398|NCT00748189|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.|||Months||95% Confidence Interval|Median
1218399|NCT00748189|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (CR, CRi, nPR, or PR). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders. Only responders (CR, CRi, PR, nPR) were included in the analysis.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Time to response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.|||Months||95% Confidence Interval|Median
1218400|NCT00748189|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the total IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
1218401|NCT00748189|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD)|MRD was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
1218409|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and were asked to rate their leg discomfort on a 100 millimeters visual analog scale every 5 minutes (score of 0-100, 0=none, higher numbers indicate more discomfort) and PLMs were assessed. The SIT-PLM Index is defined as the number of PLMs per hour during the SIT. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||number of PLMs per hour||Standard Error|Least Squares Mean
1218402|NCT00748189|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed. OR was according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.|||Participants|||Number
1218403|NCT00748189|Primary|Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|Intent-to-Treat (ITT) Population: all par. randomized to study treatment regardless of whether or not they received treatment. PFS was assessed by a blinded independent review committee according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines.|||Months||95% Confidence Interval|Median
1218404|NCT00748098|Secondary|Number of Participants Who Self-reported “Very Satisfied” or “Satisfied” With the Investigational Product at Week 4/10 Using LOCF|"Participant satisfaction with RLS medication was captured on a seven-point ordinal scale. The scale asked Overall, how satisfied are you with the medication you received for the treatment of your RLS symptoms during the study. The participant responses ranged from 1 (Very satisfied) to 7 (Very dissatisfied). A satisfied response was scored a 2."|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
1218405|NCT00748098|Secondary|"Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF"|The CGI-I scale allows the investigator to rate the participant’s global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 (“Very much improved”) or 2 (“Much improved”) are considered to be responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
1218406|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness – Severity (CGI-S) Score at Week 4/10 Using LOCF|The CGI-S scale allows the investigator to rate the severity of participants’ illness considering their total clinical experience with the participant population being studied and based on all information available at the time of rating. The scale is rated from 1-7 (1=Normal, not at all ill; 7=Among the most extremely ill patients). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
1218407|NCT00748098|Secondary|Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF|"Each participant completed the participant-completed Patient Global Impression questionnaire at the end of each Treatment Period (Weeks 4 and 10) or Early Withdrawal. This instrument was developed to capture a participant’s subjective assessment of therapy and is composed of the following 4 questions with dichotomous (Yes or No) responses: “Helped me sleep,” Helped me fall asleep faster,” “Helped me sleep longer,” and “Helped me get a better night’s sleep.”"|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
1218408|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and rated their leg discomfort on a visual analog scale every 5 minutes (range 0-100, 0=none, higher numbers indicate more discomfort). The SIT MDS is the average rating of leg discomfort during the specified time frame. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
1218436|NCT00747916|Primary|To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events.||1 year|zero participants analyzed due to early termination of study||||||
1218410|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.|Wake After Sleep Onset (WASO) is defined as the total amount of time spent awake after falling asleep until the end of PSG recording. This endpoint is measured objectively by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1218411|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Sleep efficiency is a percentage that is calculated by dividing total sleep time by the amount of time the participant was in bed during the PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes/hour||Standard Error|Least Squares Mean
1218412|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Total sleep time is the number of minutes participants slept on average during the 8-hour polysomnography. Scoring of PSG data to yield measure of total sleep time was conducted at a central site in the United States. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1218413|NCT00748098|Secondary|Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||participants|||Number
1218414|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the total number of hours spent awake the previous night due to RLS. Response to number of hours awake was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||hours||Standard Error|Least Squares Mean
1218415|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF|The number of awakenings was measured by PSG and is defined as the number of wake periods lasting at least 1 minute. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||awakenings||Standard Error|Least Squares Mean
1218416|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Participant’s Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.|Each day upon awakening, participants rated how rested they felt upon awakening on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to feeling rested upon awakening was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||scores on a scale||Standard Error|Least Squares Mean
1218417|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF|Each day upon awakening, participants rated their overall sleep quality for the previous night on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to sleep quality was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||scores on a scale||Standard Error|Least Squares Mean
1218437|NCT00747812|Primary|Number of Days With 4 or More Hours of Headache||12 Weeks||||Days||Standard Deviation|Mean
1218438|NCT00747812|Primary|Number of Hours of Headache||12 weeks||||Hours||Standard Deviation|Mean
1218418|NCT00748098|Secondary|Number of PLMAI Responders at Week 4/10 Using LOCF|PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||participants|||Number
1218419|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAWI is defined as the number of PLMs (involuntary leg movements) that caused participants to wake up per hour of sleep. It is calculated by dividing the number of PLMs causing awakening by the total number of hours of sleep. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||number of PLMs/total hours of sleep||Standard Error|Least Squares Mean
1218420|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10|Percentage of stage REM sleep time was defined as the time spent in stage REM sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
1218421|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF|In REM sleep, a participant’s breathing becomes more rapid, irregular, and shallow; eyes jerk rapidly; and limb muscles are temporarily paralyzed. Brain waves during this stage increase to levels experienced when a person is awake. This is the stage when most dreams occur. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1218422|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10|Percentage of stage N3 sleep time was defined as the time spent in stage N3 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
1218423|NCT00748098|Secondary|Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF|Stage N3 is referred to as deep sleep; it is very difficult to wake a participant in this stage of sleep. In deep sleep, there is no eye movement or muscle activity. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1218424|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10|Percentage of stage N2 sleep time was defined as the time spent in stage N2 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
1218425|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF|In stage N2 of sleep, eye movement stops and brain waves become slower, with only an occasional burst of rapid brain waves. Participants may also experience spontaneous periods of muscle tone mixed with periods of muscle relaxation. During this stage, muscular activity, and conscious awareness of the external environment disappears. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1239203|NCT00590460|Secondary|Number of Patients With Graft Failure|Graft failure is defined as engraftment of less than 65% of donor cells 100 days after transplantation.|100 days||||participants|||Number
1218426|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF|Percentage of stage N1 sleep time was defined as the time spent in stage N1 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
1218427|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF|Stage N1 is considered “light sleep,” during which participants drift in and out of sleep and can be awakened easily. In this stage, the eyes move slowly and muscle activity slows. This stage is sometimes referred to as “somnolence” or “drowsy sleep.” Sudden twitches and hypnic jerks may be associated with the onset of sleep during N1. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1218428|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF|"The IRLS is a measure of RLS disease severity. Item 4 of the IRLS evaluates RLS-related sleep impairment. It asks: In the past week, how severe was your sleep disturbance due to your RLS symptoms?. The item is participant rated using a 5-point scale, where 0 is the absence of any sleep disturbance and 4 is very severe disturbance. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
1218429|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF|The IRLS is a measure of RLS disease severity. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
1218430|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||limb movements per hour||Standard Error|Least Squares Mean
1218431|NCT00748098|Primary|Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)|"PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a sleep study that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1218432|NCT00748085|Secondary|Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection.||1 year|no analysis conducted. Study terminated for business reasons||||||
1218433|NCT00748085|Primary|Efficacy of the Cryogen on a Tumor Evaluated by Histopathological Data and Visual Inspection Along With Visual Confirmation of Absence of Scarring and Stricturing of the Airway. The Primary Safety Endpoint is the Reporting of All Adverse Events.||1 year|no analysis conducted-study terminated for business reasons||||||
1218434|NCT00748072|Primary|The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.||Immediately post-biopsy and 24 hours post-biopsy.||||participants|||Number
1218435|NCT00747916|Secondary|To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent.||1 year|zero participants analyzed due to early termination of study||||||
1239204|NCT00590460|Primary|Number of Patients With Donor Engraftment|Number of patients with engraftment of at least 65% of donor cells 100 days after transplantation|100 Days||||participants|||Number
1218440|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode(Outcome Measure Percentage of patients healed). Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After one week|Eligibility according to in/ex criteria and compliance with study requirements|||percentage of patients|||Number
1218441|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)|After two weeks||||percentage of patients|||Number
1218442|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups."|After two weeks||||percentage of patients|||Number
1218443|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups"|After one week|Eligibility per in/ex criteria and compliance with study requirements and diary completion requirements|||percentage of patients|||Number
1218444|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)|After one week|The patients were eligible according to inclusion and exclusion criteria and were compliant with the study requirements.|||percentage of patients|||Number
1218445|NCT00747643|Secondary|A Measure of the Subjective Expected Value of a Cigarette|The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).|3 weeks per participant|Per Protocol|||Dollars||Standard Error|Mean
1218446|NCT00747643|Primary|Cue-provoked Cravings|"Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale How strong was your craving to smoke a cigarette?"|3 weeks per participant|Per Protocol|||Scores on a scale||Standard Error|Mean
1218447|NCT00747643|Secondary|Smoking Topography - Number of Puffs on a Cigarette|# Puffs = total number of puffs taken at Assessment Session.|3 weeks per participant|Per Protocol|||Puffs on a Cigarette||Standard Error|Mean
1218448|NCT00747643|Primary|Tonic Craving Score (QSU) Based on Self Reports|Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.|3 weeks per participant|Per Protocol|||Scores on a scale||Standard Error|Mean
1218449|NCT00747617|Secondary|Serum Testosterone Responses to hCG|Mean serum testosterone levels before and after hCG injection. Serum testosterone levels before (-0.5 and 0 hrs) were averaged to achieve a single value|-0.5, 0, 24 hrs||||ng/ml||Standard Error|Mean
1218450|NCT00747617|Primary|Serum 17OHP Responses to hCG|Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects|24 hrs post dose|PCOS and Normal groups were analyzed according to peak 17OHP levels at each dose of r-hCG.|||ng/ml||Standard Error|Mean
1218451|NCT00747565|Primary|Mean Binocular Distance Corrected Near Visual Acuity in Snellen|Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.|One year|Binocular subjects at one year available for testing for both studies combined.|||Mean Snellen Line (with ETDRS line SD)||Standard Deviation|Mean
1218452|NCT00747565|Primary|Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.|"Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,first eye refers to the first implanted eye of each subject."|One year|First eye results from subjects at one year in both the original study and the expansion study combined.|||Participants (First Eyes only)|||Number
1218453|NCT00747552|Secondary|Median Bladder Pressure for All Measurements|Intra-abdominal Pressure (IAP) measurements will be tabulated and frequency distributions determined for patients with and without any clinical/surgical abdominal pathology. Median and quartile values will be assessed in order to describe normative values. In patients with clinical abdominal pathology (abdominal distention, necrotizing enterocolitis, abdominal wall defects, diaphragmatic hernia, etc), sequential evaluation of IAP will be done to try to identify thresholds for Intra-abdominal Hypertension (IAH).|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.|||mmHg||Inter-Quartile Range|Median
1218454|NCT00747552|Primary|Intra-abdominal Pressure(IAP) Measurements in NICU Patients.|Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.|||IAP measurements|||Number
1218455|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1239205|NCT00590369|Secondary|Patient Reported Pain|scale of 0= no pain to 10= worst pain possible|at first dressing change; generally 48 hours||||units on a scale||Standard Deviation|Mean
1218456|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218457|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218458|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218459|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218460|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1218461|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1218462|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1218463|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1218464|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1218465|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218466|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218467|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218468|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218469|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1218470|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1h, 1h30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1218471|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1218472|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1218473|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1218474|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1218475|NCT00747474|Primary|Number of Participants With Adverse Events|Number of participants with AEs that occurred during treatment and follow-up period (30 days after last treatment). Drug-related AEs and SAEs were followed until resolved or stabilized. AEs were classified by the investigator according to severity graded using CTCAE version 3.0 and relationship to study drug. The severity scale is: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to AE|an average of 6 months|Patients received at least one dose of Lipotecan|||participants|||Number
1218476|NCT00747474|Secondary|Anti-tumor Activity|Patients were evaluated by tumor assessment using RECIST guidelines. Possible evaluations include: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the size of target lesions. Progressive Disease (PD): at least a 20% increase in the size of target lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From start of treatment assessed every 2 cycles up to 2.5 years|Patients received at least one dose of Lipotecan.|||participants|||Number
1218477|NCT00747474|Primary|Maximum Tolerated Dose (MTD) of Lipotecan|MTD is the highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT)). A 3+3 study design was used to determine MTD. The MTD was the highest dose level at which 0 of 3 or 1 of 6 patients experience a DLT, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.|First treatment to toxicity up to 42 days|Patients received at least one dose of Lipotecan.|||mg/m^2|||Number
1218478|NCT00747461|Secondary|Treatment Durability|need for additional treatments within specified period|12 months|study terminated-no subjects analyzed.||||||
1218479|NCT00747461|Primary|Improvement in Luminal Patency Following Cryospray Treatment||30 days|study terminated by Sponsor-data not analyzed||||||
1218480|NCT00747435|Secondary|Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.|Satisfaction is ranked from 1-5, with 1 being very dissatisfied and 5 being very satisfied. Data reported is the percentage of subjects who experienced an increase in satisfaction when using EAS compared to preoperative hearing aids.|12 months post initial activation|Only 59 subjects completed the HDSS at preop and 12 month post activation.|||Participants|||Count of Participants
1218481|NCT00747435|Secondary|Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.|A lower score on the APHAB indicates a better performance. The global score for preoperative hearing aid use was subtracted from the global score for EAS at 12 months giving an improvement on the APHAB with EAS.|12 months post initial activation|Only 59 subjects completed the APHAB at preop and 12 months post activation.|||percentage of scoring change (APHAB)||Standard Deviation|Mean
1218482|NCT00747435|Secondary|Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.|CNC words are scored as the percent correct out of 50 words. The percent correct for preoperative hearing aid use was subtracted from the percent correct for CI Alone at 12 months giving an improvement on speech perception for CI Alone compared to preoperative hearing aids.|12 months post initial activation||||percentage of words correct (CNC)||Standard Deviation|Mean
1218483|NCT00747435|Secondary|Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition|CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for the CI Alone condition was subtracted from the total percent correct for the EAS condition at 12 months giving an improvement in speech perception with EAS compared to CI Alone.|12 months initial activation|One subject lost residual hearing immediately after surgery and was unable to use EAS. The subject was testing in cochlear implant alone condition.|||percentage of words correct (CUNY)||Standard Deviation|Mean
1218484|NCT00747435|Primary|Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.|CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.|12 months post initial activation|One subject lost residual hearing immediately following surgery and was unable to use EAS. This subject was tested with the cochlear implant alone and is not included in this analysis.|||percentage of words correct (CUNY)||Standard Deviation|Least Squares Mean
1218485|NCT00747344|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline to Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Scores on a scale||Standard Deviation|Mean
1218486|NCT00747344|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Participants|||Number
1218487|NCT00747344|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12|PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).|Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Participants|||Number
1218488|NCT00747227|Secondary|"Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent."|"Subjects indicating a subjective response to a multiple choice question, At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?, on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit."|One Year|Two subjects in the ZV9003 group did not complete the one year questionnaire.|||participants|||Number
1218489|NCT00747227|Primary|Uncorrected Distance Visual Acuity|Snellen Equivalent of 20/40 or better at one year|One Year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.|||participants|||Number
1218490|NCT00747227|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|4-6 months|Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported.|||log contrast||90% Confidence Interval|Mean
1218491|NCT00747227|Primary|Best Corrected Distance Visual Acuity|Snellen Equivalent visual acuity of 20/40 or better|One year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.|||participants|||Number
1218492|NCT00747214|Secondary|Change in Fatigue (MAF Scale) Score From Baseline to Day 42|"The Multidimensional Assessment of Fatigue (MAF) scale is a self-administered, 16 item questionnaire to measure self-reported fatigue (http://www.son.washington.edu/research/maf/). The following steps were used to calculate a single score ranging from 1 (no fatigue) to 50 (severe fatigue).~Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5~Sum items #1, 2, and 3~Average items #4 through 14~Add results from above Steps 1 through 3 to obtain a single score~A score was not be assigned to items #4 through 14 if a respondent indicated they did not engage any activity for reasons other than fatigue. If respondent selected “no fatigue” on item #1, a 0 was to be assigned to items #2 through 16; item #16 was not included in the global fatigue index."|Baseline and Day 42||||units on a scale||Standard Deviation|Mean
1218493|NCT00747214|Secondary|Change in DAS28 Score From Baseline to Day 42|To calculate the DAS28, the number of swollen joints and tender joints should be assessed using 28-joint counts, the ESR should have been measured in mm/hour, and the patient's general health (GH) or global disease activity measured on a Visual Analog Scale (VAS) of 100 mm must be obtained. Using these data, the DAS28 could be calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The DAS28 provides a number between 0 and 10 that indicates the current activity of RA in the subject. A DAS28 above 5.1 means high disease activity and below 3.2 indicates low activity. Remission is achieved when a DAS28 score is lower than 2.6. The DAS28 measurements were to be taken at each visit.|Baseline and Day 42||||units on a scale||Standard Deviation|Mean
1218494|NCT00747214|Secondary|Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)|The percentage of subjects in each group that achieved an ACR 20 response on Day 42|Day 42||||percentage of participants|||Number
1218495|NCT00747214|Primary|Change in CRP From Baseline to Day 42|The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.|Baseline and Day 42||||percentage change from baseline||Standard Deviation|Mean
1218496|NCT00747149|Secondary|Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy||6 and 12 Weeks|||||||
1218497|NCT00747149|Secondary|Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12||6 and 12 Weeks|||||||
1218498|NCT00747149|Secondary|Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio||6 and 12 Weeks|||||||
1218499|NCT00747149|Secondary|Percentage of Subjects Achieving Total Cholesterol (TC)/ High-density Lipoprotein Cholesterol (HDLC) Ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 Weeks of Treatment|Proportion of subjects achieving total cholesterol (TC)/ High-density lipoprotein cholesterol (HDLC) ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 weeks of treatment|6 and 12 Weeks|||||||
1218500|NCT00747149|Primary|Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy|The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100|12 Weeks||||Percentage||95% Confidence Interval|Mean
1218501|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
1218502|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
1218503|NCT00747006|Secondary|Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
1239206|NCT00590369|Secondary|Nursing Time||hospital stay; generally 6 days||||minutes||Standard Deviation|Mean
1218504|NCT00747006|Secondary|Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
1218505|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||mg/dL||Full Range|Mean
1218506|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus TI Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||mg/dL||Full Range|Mean
1218507|NCT00747006|Primary|Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||mg/dL||Full Range|Mean
1218508|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||mg/dL||Full Range|Mean
1218509|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
1218510|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
1218511|NCT00747006|Primary|Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
1218512|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
1218513|NCT00746954|Primary|Apnea-hypopnea Index (Number of Central and Mixed Apneas/Hour of Sleep)||Overnight polysomnogram over 3 separate nights|Comparisons among Drugs (not Arms)|||APNEA-HYPOPNEA/HR by drug or placebo||Standard Deviation|Mean
1218514|NCT00746941|Secondary|Participants Who Died Within 6 Months|The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen.|Day 1 up to 6 months|"Safety population: All participants who enrolled in the study and were dosed, and who have at least 1 post-baseline safety assessment.~The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen."|||participants|||Number
1218515|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||log10 mm^3||Standard Deviation|Mean
1218516|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||log10 mm^3||Standard Deviation|Mean
1218517|NCT00746941|Secondary|Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||participants|||Number
1218518|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS)|"Participants rate their neurological function on a scale of 100 mm line, where the 0 end of the scale indicates poor neurological function and 100 indicates excellent neurological function. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
1218519|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT)|"The SDMT is a simple substitution task. The test gives participants 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0 (worst outcome) to 110 (best outcome).~Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. SDMT was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
1218520|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score|"The KPS Index classifies participants' functional impairment. KPS can be used to compare effectiveness of different therapies and to assess the prognosis in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the KPS score, the worse the survival for most serious illnesses. The KPS index is subdivided into 3 categories: incapacitated (0 to 40), self-care (50 to 70), and normal activity (80 to 100).~Negative change from baseline scores indicate improved prognosis."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
1218521|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) Score|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death) was calculated. Negative change scores indicate improvement.|Day 0 (baseline), Week 4 and 8|"Participants with values at the time frames being measured. EDSS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
1218522|NCT00746941|Primary|Change From Baseline to Week 8 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 8 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.~Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 8|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.~Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 8 were available."|||log10 copies/mL||Standard Deviation|Mean
1218523|NCT00746941|Primary|Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 4 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.~Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 4|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.~Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 4 were available."|||log10 copies/mL||Standard Deviation|Mean
1218524|NCT00746889|Other Pre-specified|Change in WOMAC Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 12 weeks|These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group.|||units on a scale||Standard Deviation|Mean
1218525|NCT00746889|Primary|Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 4 weeks|This population was defined as patients who completed the 4 week follow up assessment as per protocol.|||units on a scale||Standard Deviation|Mean
1218526|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.|At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|24 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected.|||cm||Standard Deviation|Mean
1218527|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.|At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|6 hours postoperative from mid-urethral sling placement|Intention to treat|||cm||Standard Deviation|Mean
1218528|NCT00746863|Secondary|Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.|Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row.|From after surgery to discharge from hospital.||||participants w/sucessful voiding trial|||Number
1218530|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.|At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|2 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected.|||cm||Standard Deviation|Mean
1218531|NCT00746798|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.||Day 0 up to Day 14 post-vaccination|Safety assessments were on the Safety, intend-to-treat Population.|||Participants|||Number
1218532|NCT00746798|Primary|Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|"Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test.~Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10."|Day 0 and Day 28 post-vaccination|Serum antibody levels and seroconversion were assessed in the per-protocol population.|||Participants|||Number
1218533|NCT00746798|Secondary|Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units [pfu]/mL) viremia at the reported visit.|Day 2 up to Day 14 post-vaccination|Viremia concentrations were assessed in a randomly selected subset of the per-protocol population.|||Participants|||Number
1218534|NCT00746798|Primary|Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine|Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.|Day 0 and Day 28 post-vaccination|Serum antibody levels were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1218535|NCT00746785|Primary|Drinks Per Drinking Day|"Drinks are measured as the number of standard alcoholic beverages consumed each day, assessed in varying lengths of time (i.e., 2 weeks, 4 weeks, 6 weeks, etc.). A standard alcoholic beverage is equivalent to: 1, 12 oz. regular beer; 1, 5 oz. glass of wine; 1, mixed drink with one1.5 oz shot; or 1, 1.5 oz shot. A drinking day is measured as any day of the week in which an alcoholic beverage is consumed. Data for drinks per drinking day is gathered using the Time Line Follow Back method in which participants are asked to recall their alcohol consumption day by day for a pre-defined set of time."|up to 36 weeks||||Drinks per drinking day||Standard Deviation|Mean
1218536|NCT00746733|Primary|T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1218537|NCT00746733|Primary|AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
1218538|NCT00746733|Primary|Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1218539|NCT00746733|Primary|Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||ng/ml||Standard Deviation|Mean
1218540|NCT00746733|Primary|T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1218541|NCT00746733|Primary|AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC||0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
1218542|NCT00746733|Primary|Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1218543|NCT00746733|Primary|Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||ng/ml||Standard Deviation|Mean
1218544|NCT00746733|Secondary|Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Pre-dose, 2 and 8 hours after dosing|Safety population|||msec||Standard Deviation|Mean
1218545|NCT00746733|Secondary|Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population|||bpm||Standard Deviation|Mean
1218546|NCT00746733|Secondary|Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population|||mmHg||Standard Deviation|Mean
1218547|NCT00746733|Primary|Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1218548|NCT00746733|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
1218549|NCT00746733|Primary|Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1219334|NCT00738673|Secondary|Participants at Testosterone Castrate Level Throughout the Study|Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.|up to month 12|Intent to treat population|||participants|||Number
1218550|NCT00746733|Secondary|Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1218551|NCT00746733|Secondary|DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population|||units on a scale||Standard Deviation|Mean
1218552|NCT00746733|Secondary|DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population|||units on a scale||Standard Deviation|Mean
1218553|NCT00746733|Secondary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported.|||units on a scale||Standard Deviation|Mean
1218554|NCT00746733|Primary|Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles.|||ng/ml||Standard Deviation|Mean
1218555|NCT00746694|Primary|Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE|The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.|Participants will do a single visit, but cases will be collected during a period of 12 months.||||Participants|||Number
1218556|NCT00746694|Primary|Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)|"Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE.~Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it."|Participants will do a single visit, but cases will be collected during a period of 12 months.||||Participants|||Number
1218557|NCT00746668|Primary|Sentence Reading|To assess reading performance, after each training module (1-3), two lines of text were presented at the center of the monitor. Each subject was seated with his or her forehead on a head rest at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test. The number of words read correctly was divided by the time required to read the sentence to yield a measure of reading speed in words per minute (wpm). Sentences were displayed at sizes of 0.1, 0.2, 0.3, 0.4, 0.5, and 0.6 log units above the subject's letter acuity threshold. Five sentences were presented at each font size. We used 105 different sentences so that no sentence was repeated for any subject. Average speed of reading (log wpm) was plotted as a function of font size (logMAR).|Pre-training, 6 weeks, 12 weeks, 18 weeks|Intent to Treat|||Words per Minute (wpm)||Standard Deviation|Mean
1218558|NCT00746590|Secondary|Changes in Laboratory Measurements||Baseline and every 3 weeks until progression|||||||
1218559|NCT00746590|Secondary|Adverse Events||Until progression|||||||
1218560|NCT00746590|Secondary|Changes in Alpha Fetoprotein||Baseline, every 3 weeks until progression|||||||
1218561|NCT00746590|Secondary|Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour||Every 6 weeks until progression|||||||
1218562|NCT00746590|Secondary|Time to Tumour Progression||Every 3 weeks until progression|||||||
1218563|NCT00746590|Secondary|Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease||Approximately 12 weeks or more after first treatment with Prolarix|||||||
1218564|NCT00746590|Primary|Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST||every 6 weeks until progression|Study was terminated prematurely after only 1 patient was enrolled. The patient died one month after the initial dose of Prolarix, but his death was unrelated to Prolarix administration.|||participants||Standard Deviation|Mean
1218565|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings – Phase II|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.|6 weeks|All patients implanted with the SJM Confirm device in participating in Phase II. Total patients 36: (19 rollovers from Phase I enrollments)+(25 Phase II enrollments)-(1 withdrawal)-(7 subjects with no automatically triggered recordings). Total recordings obtained: 958|||percentage of inappropriate recordings|Participants|95% Confidence Interval|Number
1218566|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings – Phase I|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes).|||percentage of inappropriate recordings|Participants|95% Confidence Interval|Number
1239207|NCT00590369|Secondary|Cost of Wound Care|cost of device/supplies used in application and dressing changes|during hospital stay; generally 6 days||||dollars (USD)||Standard Deviation|Mean
1218567|NCT00746564|Other Pre-specified|Interpretability of Automatically Triggered/Symptom Driven Recordings|The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes). Total analyzable recordings 2804.|||percentage of interpretable recordings|Participants|95% Confidence Interval|Number
1218568|NCT00746564|Other Pre-specified|Interpretability of Weekly Subject Activator Recordings|The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 30; 50-(1 withdrawal)-(19 patients who did not initiate recordings). Total analyzable recordings 58.|||percentage of interpretable recordings|Participants|95% Confidence Interval|Number
1218569|NCT00746564|Primary|Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers|The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 92: 96 obtained-(4 recordings with zero visible R waves)|||percentage of recordings|Participants|95% Confidence Interval|Number
1218570|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 45; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel)-(2 patients where no recording was obtained). Total analyzable recordings 45: 46 obtained-(1 recording with zero visible R waves).|||percentage of recordings|Participants|95% Confidence Interval|Number
1218571|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings at Rest|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient with no recording obtained). Total analyzable recordings 89.|||percentage of recordings|Participants|95% Confidence Interval|Number
1218572|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 82; 96 obtained-(14 recordings with zero visible R waves)=82 recordings|||percentage of recordings|Participants|95% Confidence Interval|Number
1218573|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 46; 50-(1 withdrawal)-(1 patient's recording lacking surface ECG channel)-(2 no recording obtained). Total analyzable recordings =39; 46 obtained-(7 with zero visible R waves).|||percentage of recordings|Participants|95% Confidence Interval|Number
1218574|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings at Rest|The sensitivity was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I were included in this analysis. Total patients 48; 50-(1 withdrawal)-(1 patient with recording lacking the surface channel). Total analyzable recordings 88; 89-(1 recording lacking visible R waves).|||percentage of recordings|Participants|95% Confidence Interval|Number
1218575|NCT00746551|Secondary|Haemoglobin Level||3 weeks after intervention||||g/dL||Standard Deviation|Mean
1218576|NCT00746551|Primary|Serum Ferritin Level||3 weeks after intervention||||µg/dL||Standard Deviation|Mean
1218577|NCT00746512|Secondary|Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])|"The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was:~DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96.~Where SQR is square root and ln is natural log.~The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission."|Baseline and Day 14||||score on scale||Standard Deviation|Mean
1218578|NCT00746512|Primary|Synovial Blood Flow|Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.|Baseline and Day 14||||pixel count||Standard Deviation|Mean
1218579|NCT00746421|Secondary|Brief Assessment of Cognition for Affective Disorders (BAC-A)|This is a series of neurocognitive tests and includes brief assessments of attention, motor speed, working memory, verbal memory, reasoning and problem solving, verbal fluency, affective interference, and emotion inhibition. The total BAC-A score is represented by a composite T-score which is dimensionless. This is computed by adding up the scores for each trial of a test domain (e.g. verbal memory) within the cognitive battery. Each test domain total is then inputted into a proprietary BAC-A calculator which determines the composite T-scores. A higher score indicates better performance. A study of 404 healthy adults demonstrated a mean composite score of 50 with a standard deviation of 10 (Keefe et al. Schizophrenia Bulletin. 2008; 102: 108-115).|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.|||units on a scale (composite t-score)||Standard Deviation|Mean
1219152|NCT00740714|Secondary|CoQ10 Levels in Plasma|Based on samples analyzed to date|Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants have been included and data is based on samples analyzed to date.|||ug/ml||Standard Deviation|Mean
1218580|NCT00746421|Primary|The Continuous Performance Test-Identical Pairs Version|The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the d' scores from three trials.|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.|||units on a scale||Standard Deviation|Mean
1218581|NCT00746395|Secondary|Small Bowel Transit|Small bowel transit time|Duration of the test - 8 hours|Patients without transit to cecum were excluded|||Minutes||Standard Error|Mean
1218582|NCT00746395|Primary|Complete Small Bowel Transit|Percent of subjects with capsule passage through small bowel|8 hours|Placebo 95%, lubiprostone 75%|||percentage of subjects with passage|||Number
1218583|NCT00746356|Primary|Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle were included in the analysis.|||Volts||Standard Deviation|Mean
1218584|NCT00746356|Primary|Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle were included in this analysis.|||Volts||Standard Deviation|Mean
1218585|NCT00746356|Primary|Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold test were included in this analysis.|||Volts||Standard Deviation|Mean
1218586|NCT00746356|Primary|Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.|3 months post implant|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold test were included in this analysis.|||Volts||Standard Deviation|Mean
1218587|NCT00746356|Primary|Percentage of Participants Free of System-related Complications at 3-months Post Implant||3 months post implant||||Percentage of Participants|||Number
1218588|NCT00746330|Secondary|Urinary Excretion of Formoterol Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in urine was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for urine was 0.0174 nmol/L expressed as free base. The amounts of unchanged formoterol excreted in urine from 0 to 3 hours (Ae0-3) and from 0 to 12 hours post-dose (Ae0-12) were calculated from the formoterol concentrations in urine and the urine volumes using non-compartmental methods.|0 to 3 hrs and 0-12 hrs|The pharmacokinetic population which was modified by the exclusion of dosing periods where formoterol was present at a concentration in excess of 5% of the Cmax.Five subjects were excluded due to various reasons.|||nmol||90% Confidence Interval|Least Squares Mean
1218589|NCT00746330|Secondary|Plasma Formoterol Concentrations (Pmol/L) Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in plasma was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for plasma was 1.45 pmol/L. No non-compartmental PK analysis was performed.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Because of the dosing periods where formoterol was present at concentrations greater than 5% of the Cmax data for 4 subjects was excluded. A dosing error resulted in the exclusion of 1 subject and 1 subject had all data excluded from PK evaluation due to the plasma drug concentrations in conflict with the recorded randomization.|||pmol/L||Standard Deviation|Mean
1218741|NCT00744692|Secondary|To Evaluate the Incidence of Late Graft Failures at 2 Years Post-transplant||2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late graft failure endpoint.|||participants|||Number
1218590|NCT00746330|Secondary|Serial Peak Expiratory Flow Rate (PEF) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS/ERS standards|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
1218591|NCT00746330|Secondary|Serial Forced Vital Capacity (FVC) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FVC is the volume (liters) of air that can forcibly be blown out after full inspiration. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS / ERS standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
1218592|NCT00746330|Secondary|Serial FEV1 Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FEV1 is the maximum amount of air expired in one second. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the (ATS / ERS) standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
1218593|NCT00746330|Primary|The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment|For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose|From 0 to 12 Hours (0-12h) post-dose, after each treatment administered (approximately 1 treatment a week for 4 weeks of treatment).|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
1218594|NCT00746252|Primary|Weight Gain|Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.|These measurements are done biweekly from baseline up until 12 weeks||||pounds||Standard Deviation|Mean
1218595|NCT00746239|Secondary|Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.||10 weeks|||||||
1218596|NCT00746239|Primary|Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.||10 weeks|||||||
1218597|NCT00746187|Primary|Marginal Bone Level Changes|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.|3 years after implant placement (baseline)|Per protocol analysis presented and this includes 86 implants in 36 patients. At 3-year follow-up, 74 implants in 31 patients were still in the study and thus evaluable for the analysis.|||millimeter|Participants|Standard Deviation|Mean
1218598|NCT00746096|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks||||units on a scale||Standard Deviation|Mean
1218599|NCT00746096|Primary|Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|"Five patients in the IKH-01 group were excluded from efficacy analysis due to no available data for 3 patients and 2-4 administration days for 2 patients.~One patient in the placebo group was also excluded from efficacy analysis."|||units on a scale||Standard Deviation|Mean
1218600|NCT00746018|Primary|To Determine if the LigaSure Device, Which we Routinely Used for Removal of Tubes and Ovaries, is Effective at Destroying All Tubal Cells Comprising the Fallopian Tube Including Those Cells Within the Cornua of the Uterus.||conclusion of the study|Data were not collected||||||
1218601|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Acceptance Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1218602|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Awareness Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1218603|NCT00745940|Secondary|Symptom Checklist-90 Revised (Depression Subscale)|The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from “Not at All” to “Extremely” with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1218604|NCT00745940|Primary|Beck Depression Inventory - II|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders—Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1218605|NCT00745940|Secondary|Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27."|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1218606|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Participants|||Number
1218607|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 2|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Participants|||Number
1218608|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 1|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
1218609|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Participants|||Number
1218610|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 2|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Participants|||Number
1218611|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 1|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
1218612|NCT00745901|Primary|Overall Number of Days of Total Blood Loss|cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 to 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1218742|NCT00744692|Secondary|To Evaluate Long-term Complications, Such as Sterility, Endocrinopathy, and Growth Failure||at least 2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late effects endpoint.|||percentage of patients|||Number
1218613|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 3 (Day 57 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
1218614|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 2 (day 29 to Day 56)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
1218615|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 (Day 8 to Day 28)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1218616|NCT00745901|Primary|Overall Number of Days of Scheduled Blood Loss|summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 to Cycle 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1218617|NCT00745901|Primary|Number of Days of Scheduled Blood Loss – Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
1218618|NCT00745901|Primary|Number of Days of Scheduled Blood Loss – Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
1218619|NCT00745901|Primary|Number of Days of Scheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1218620|NCT00745901|Primary|Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes|Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
1218621|NCT00745901|Primary|Overall Number of Days of Unscheduled Blood Loss|cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1218622|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 3|Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
1218623|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
1218624|NCT00745901|Secondary|Patient Satisfaction - Overall|patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.|Cycle 1 to Cycle 3|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
1218743|NCT00744692|Secondary|To Describe the Incidence of Grade 3-4 Organ Toxicity||2 years post transplant||||participants|||Number
1219164|NCT00740480|Primary|Coaptation (Tissue Approximation)|Complete tissue approximation at one week.|One week post surgery|ITT|||participants|||Number
1218625|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1218626|NCT00745875|Secondary|Progression-free Survival|Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method|Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation||||Days||Full Range|Median
1218627|NCT00745875|Primary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)|Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010).||||Days||Full Range|Median
1218628|NCT00745823|Secondary|Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|||||||
1218629|NCT00745823|Secondary|Number of Participants With One or More Adverse Events at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|||||||
1218630|NCT00745823|Secondary|Mean Change From Baseline to Week 96 in CD4 Cell Count|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Baseline and Week 96|The Week 96 data analysis was not performed.||||||
1218631|NCT00745823|Secondary|Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.||||||
1218632|NCT00745823|Secondary|Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.||||||
1218633|NCT00745823|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count||Baseline and Week 48|Data were analyzed for all participants treated with study drug. Baseline values were carried forward for participants who discontinued treatment due to lack of efficacy.|||cells/mm^3||95% Confidence Interval|Mean
1218634|NCT00745823|Primary|Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.|||Participants|||Number
1218635|NCT00745823|Primary|Number of Participants With One or More Adverse Events at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.|||Participants|||Number
1218636|NCT00745823|Secondary|Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks||48 weeks|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.|||Participants|||Number
1218637|NCT00745823|Primary|Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks||Week 48|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.|||Participants|||Number
1218638|NCT00745498|Secondary|Postoperative Resolution of Neovascularization||6 months|||||||
1218639|NCT00745498|Secondary|Visual Outcome|Best-corrected visual acuity (BCVA) at postoperative 6 months|6 months||||logMAR||Standard Deviation|Mean
1218640|NCT00745498|Secondary|Initial Time of Vitreous Clearing (ITVC)|The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels.|6 months||||days||Standard Deviation|Mean
1218641|NCT00745498|Primary|Recurrent VH Incidence (Early and Late)|"Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. Early recurrent VH was VH occurring <= 4 weeks and late recurrent VH was VH occurring >4 weeks after surgery."|6 months|With study power of 80%, significance level of 0.05, assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated. The ITT approach was used for analysis.|||Percentage of participants|||Number
1218642|NCT00745420|Secondary|Change From Baseline to 1 Year in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to 1 year post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|1 year post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1218643|NCT00745420|Secondary|Change From Baseline to 1 Year in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to 1 year post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|1 year post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1218744|NCT00744692|Secondary|To Describe Incidence of Acute Graft Versus Host Disease (GVHD) (II - IV)|To describe incidence of acute Graft Versus Host Disease (GVHD) (II - IV) : measured by cumulative incidence analysis|100 days post transplant||||percentage of participants||95% Confidence Interval|Number
1218644|NCT00745420|Secondary|Change From Baseline to Day 180 in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 180 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|180 days post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1218645|NCT00745420|Secondary|Change From Baseline to Day 180 in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 180 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|180 days post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1218646|NCT00745420|Secondary|Change From Baseline to Day 100 in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 100 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|100 days post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1218647|NCT00745420|Secondary|Change From Baseline to Day 100 in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 100 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|100 days post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1218648|NCT00745420|Secondary|Percentage of Participants With Posterior Reversible Encephalopathy Syndrome (PRES)||1 year||||percentage of participants||95% Confidence Interval|Number
1218649|NCT00745420|Secondary|Number of Participants With Chronic GVHD by Severity|Chronic GVHD severity is defined per NIH 2005 Consensus Criteria.|1 year post-transplant||||Participants|||Count of Participants
1218650|NCT00745420|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is defined per NIH 2005 Consensus Criteria.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
1218651|NCT00745420|Secondary|Percentage of Participants With Acute Graft-vs-Host-Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|100 days||||percentage of participants||95% Confidence Interval|Number
1218652|NCT00745420|Secondary|Graft Rejection|Primary graft rejection is defined as the presence of less than 20% donor cells as assessed by peripheral blood or bone marrow chimerism assays on or after Day 42. Secondary graft rejection is defined as the presence of less than 20% donor derived hematopoietic cells in peripheral blood or bone marrow that occurs after prior evidence of 20% or greater donor cells.|1 year||||Participants|||Count of Participants
1218653|NCT00745420|Secondary|Neutrophil and Platelet Recovery|Time to neutrophil recovery is defined as the time of the first of three measurements on consecutive days where the patient has an absolute neutrophil count of >= 500/uL following conditioning regimen induced nadir. Time to platelet recovery is defined as the time of the first of three measurements on consecutive days where the patient has achieved a platelet count > 50,000/uL and is platelet transfusion independent for a minimum of seven days following conditioning regimen induced nadir.|Up to 100 days||||days||Full Range|Median
1218654|NCT00745420|Secondary|Percentage of Participants With Overall Survival (OS)|OS is defined as the percentage of participants that have not died.|2 years||||percentage of participants||95% Confidence Interval|Number
1218655|NCT00745420|Primary|Percentage of Participants With Event-Free Survival (EFS)|EFS is defined as percentage of participants that have not had an event. Primary or secondary graft rejection, disease recurrence, or death will count as events for this endpoint.|2 years||||percentage of participants||95% Confidence Interval|Number
1218656|NCT00745368|Primary|Female Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose||||ratio||Inter-Quartile Range|Median
1218657|NCT00745368|Primary|Male Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose||||ratio||Inter-Quartile Range|Median
1218658|NCT00745368|Primary|Female Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose||||hours||Inter-Quartile Range|Median
1218659|NCT00745368|Primary|Male Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose||||hours||Inter-Quartile Range|Median
1218665|NCT00745290|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|The subject’s pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?”|through 72 hours post surgery|Note: 245 subjects were randomized and received study drug and were included in the analyses.|||Units on a scale*hours||Standard Deviation|Mean
1218666|NCT00745251|Secondary|Percent Change in Weight From Baseline to Week 28||baseline to week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
1218667|NCT00745251|Primary|Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.|AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep|between baseline and Week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||events/hour||Standard Error|Least Squares Mean
1218668|NCT00745095|Secondary|Polyp Detection|The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.|Time of Study||||Number of polyps detected (numerical)||Standard Deviation|Mean
1218669|NCT00745095|Primary|Quality of Bowel Preparation|The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content.|1-2 days following intervention||||units on a scale||Standard Deviation|Mean
1218670|NCT00745030|Secondary|Study Terminated Due to Low Subject Recruitment and Enrollment.|Low subject recruitment and enrollment||||||||
1218671|NCT00745030|Secondary|Changes in The Montreal Cognitive Assessment Scale (MoCA)||12 weeks|||||||
1218672|NCT00745030|Secondary|Changes in Mini-Mental State Exam (MMSE)||12 weeks|||||||
1218673|NCT00745030|Secondary|Changes in Physician Completed United Parkinson’s Disease Rating Scale (UPDRS)||12 weeks|||||||
1218674|NCT00745030|Secondary|Changes in Patient Completed PDQ-39 Scale(PD-specific Quality of Life Scale)||12 weeks|||||||
1218675|NCT00745030|Secondary|Changes in Patient Completed The Fatigue Severity Scale (FSS)||12 weeks|||||||
1218676|NCT00745030|Secondary|Changes in Pittsburgh Sleep Quality Index (PSQI) (Patient Completed)||12 weeks|||||||
1218677|NCT00745030|Secondary|Changes in Beck Depression Inventory (BDI)||12 weeks|||||||
1218678|NCT00745030|Secondary|Changes in Patient Completed Epworth Sleepiness Scale (ESS)||12 weeks|||||||
1218679|NCT00745030|Secondary|Changes in Patient Completed Parkinson's Disease Sleep Scale (PDSS)- the Only Validated PD Specific, Questionnaire-based, Sleep Evaluation Scale||12 weeks|||||||
1218680|NCT00745030|Secondary|Changes in RBD Structured Questionnaire (Completed by Patient and Bed Partner)||12 weeks|||||||
1218681|NCT00745030|Secondary|Changes in Clinician Global Impression Scale of Improvement (CGI-I)||10 weeks|||||||
1218682|NCT00745030|Secondary|Changes in Mean TST, LPS, WASO (Based on PSG)||8 weeks|||||||
1218683|NCT00745030|Secondary|Change in the Amount of Tonic Muscle Activity Based on the Results of the Baseline and Final Polysomnographic (PSG) Study||8 weeks|||||||
1218684|NCT00745030|Primary|Change in the Frequency of RBD Based on the Daily Sleep Diaries, Completed Daily for the Duration of the Study by the Study Subjects' Bed Partners/Caregivers|"Change in the frequency of RBD based on the daily sleep diaries, completed daily for the duration of the study by the study subjects' bed partners/caregivers.~Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment."|12 weeks||||Participants|||Number
1218685|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Identification at Week 6.|||log10 millisecond||Standard Error|Least Squares Mean
1218686|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Identification at Week 3.|||log10 millisecond||Standard Error|Least Squares Mean
1218687|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Identification at Week 1.|||log10 millisecond||Standard Error|Least Squares Mean
1218688|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for Visual Learning at Week 6.|||arcsine proportion correct||Standard Error|Least Squares Mean
1218745|NCT00744692|Secondary|To Determine the Overall Survival at day180 Post-transplant|To determine the overall survival at day180 post-transplant: determined by Kaplan Meier survival analysis|180 days||||percentage of participants||95% Confidence Interval|Number
1218689|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for Visual Learning at Week 3.|||arcsine proportion correct||Standard Error|Least Squares Mean
1218690|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for Visual Learning at Week 1.|||arcsine proportion correct||Standard Error|Least Squares Mean
1218691|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 6.|||arcsine proportion correct||Standard Error|Least Squares Mean
1218692|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 3.|||arcsine proportion correct||Standard Error|Least Squares Mean
1218693|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 1.|||arcsine proportion correct||Standard Error|Least Squares Mean
1218694|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 6|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 6.|||errors||Standard Error|Least Squares Mean
1218695|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 3|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 3.|||errors||Standard Error|Least Squares Mean
1218696|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 1|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 1.|||errors||Standard Error|Least Squares Mean
1218697|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Detection at Week 6.|||log10 millisecond||Standard Error|Least Squares Mean
1218698|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Detection at Week 3.|||log10 millisecond||Standard Error|Least Squares Mean
1218699|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Detection at Week 1.|||log10 millisecond||Standard Error|Least Squares Mean
1218700|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 6|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 6|FAS. N = number of participants with a NPI total score at Week 6.|||scores on scale||Standard Error|Least Squares Mean
1219165|NCT00740220|Primary|Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)|The kappa statistic is a measure of the quality of a test. It is a ratio.|All three 6MWTs should take place within 30 days||||Ratio|||Number
1218701|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 3|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 3|FAS. N = number of participants with a NPI total score at Week 3.|||scores on scale||Standard Error|Least Squares Mean
1218702|NCT00744978|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 6|FAS; N = number of participants with a CGI-I score at Week 6.|||units on a scale||Standard Error|Least Squares Mean
1218703|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 6|FAS. N = number of participants with ADAS-Cog 70 results at Week 6.|||units on scale||Standard Error|Least Squares Mean
1218704|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 3|FAS. N = number of participants with ADAS-Cog 70 results at Week 3.|||units on scale||Standard Error|Least Squares Mean
1218705|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 3|FAS; N = number of participants with ADAS-Cog 75 results at Week 3.|||units on scale||Standard Error|Least Squares Mean
1218706|NCT00744978|Primary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 6|Full analysis set (FAS): all participants who were randomized and took at least 1 dose of randomized study medication. N = number of participants with ADAS-Cog 75 results at Week 6.|||units on scale||Standard Error|Least Squares Mean
1218707|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1218708|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1218709|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
1218710|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set.|||Participants|||Number
1218711|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle ore epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1220414|NCT00732940|Secondary|Absolute Change From Baseline in Complement C4 at Week 24||Baseline, 24 weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.|||mg/dL||Standard Error|Mean
1218712|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1218713|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
1218714|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
1218715|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1218716|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1218729|NCT00744848|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?”|through 96 hours|Note: 204 randomized subjects received study drug and were included in the analyses.|||Units on a scale*hours||Standard Deviation|Mean
1219286|NCT00739336|Primary|Body Weight|Weight loss in kg|3 months|"Participants from the wait-list Control Arm have been combined in the Intervention Arm with those receiving the intervention immediately upon study entry for the purposes of this analysis."|||kg||95% Confidence Interval|Mean
1218717|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set|||Participants|||Number
1218718|NCT00744939|Primary|Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set|||Participants|||Number
1218719|NCT00744874|Secondary|Total Fluoroscopy Time|Total time that flouroscopy was used during the ablation procedure.|Post Ablation Procedure||||minutes||Standard Deviation|Mean
1218720|NCT00744874|Secondary|Total Procedure Time|Measurement of total procedure time defined as “skin to skin” and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)|End of Procedure||||minutes||Standard Deviation|Mean
1218721|NCT00744874|Secondary|Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins|Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation|After Procedure||||minutes||Standard Deviation|Mean
1218722|NCT00744874|Secondary|The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline|The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score.|6 months||||units on a scale||Standard Deviation|Mean
1218723|NCT00744874|Secondary|Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months|Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).|6 Months||||units on a scale||Standard Deviation|Mean
1218724|NCT00744874|Primary|Chronic Safety|The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.|7 day post procedure to 6 months|The Chronic Safety Endpoint is the proportion of subjects with serious procedure and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.|||participants|||Number
1218725|NCT00744874|Primary|Acute Safety|The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site.|7 days post procedure|The proportion of subjects with one or more serious procedure and/or device related AEs occurring within 7 days of the ablation procedure. No acute events were related to the device.|||participants|||Number
1218726|NCT00744874|Primary|Chronic Effectiveness|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.|6 months|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.|||participants|||Number
1218727|NCT00744874|Primary|Number of Participants With Successful Pulmonary Vein Isolation|Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.|6 months|Subjects that had successful pulmonary vein isolation.|||participants|||Number
1218728|NCT00744848|Secondary|Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30||through day 30|||||||
1219287|NCT00739310|Primary|Hospitalizations Lasting at Least 24 Hours in This Patient Population|Hospitalizations lasting at least 24 hours|end of study||||hospitalizations|||Number
1218730|NCT00744757|Secondary|Quality of Life Assessment|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life.|Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days)|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1218731|NCT00744757|Secondary|Number of Events Which Led to Hospitalization|The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported.|Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Events|||Number
1218732|NCT00744757|Secondary|Duration for Hospitalization|Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission.|Cycle 1 up to Cycle 8, each cycle of 28 days.|ITT population was defined as all participants who had received at least one dose of treatment. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Days||Standard Deviation|Mean
1218733|NCT00744757|Secondary|Percentage of Participants With Transfusion Independency|Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks.|8 weeks before first dose and 736 days of treatment|ITT population was defined as all participants who had received at least 1 dose of study medication.|||percentage of participants|||Number
1218734|NCT00744757|Secondary|Percentage of Participants With Transfusion Dependency|Transfusion requirements for both red blood cells as well as platelets were recorded for each participant.|8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Percentage of participants|||Number
1218735|NCT00744757|Secondary|Overall Survival|Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Months||Full Range|Median
1218736|NCT00744757|Secondary|Time to Acute Myeloid Leukemia (AML) Progression or Death|Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Months||Full Range|Median
1218737|NCT00744757|Secondary|Percentage of Participants With Cytogenetic Response|Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|ITT population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated at given time point.|||Percentage of participants|||Number
1218738|NCT00744757|Secondary|Percentage of Participants With Hematologic Treatment Response|Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment<11 gram per deciliter [g/dl]):hemoglobin increase by>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment<100*109/l):absolute increase of >=30*10^9/l for participants starting with>20*10^9/l and increase from <20*10^9/l to>20*10^9/l and by at least 100%. HI-N response (pre-treatment<1.0*10^9/l): at least 100% increase and an absolute increase >0.5*10^9/l.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|Intent-to-treat (ITT) population was defined as all participants who had received at least one dose of treatment. Here ‘N’ specifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluable for this outcome measure at given time point.|||Percentage of participants|||Number
1218739|NCT00744757|Primary|Percentage of Participants With Response|Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin >=11 gram (g) per deciliter (dl), platelets >=100*10^9 liter (l), neutrophils >=1.0*10^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by >=50% over pre-treatment but still >=5%.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|The efficacy-evaluable (EE) population included all participants who received at least 2 cycles of treatment. Participants who died before receiving 2 complete cycles or were taken off study due to progressive disease were included. Here ‘N’ specifies those participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1218740|NCT00744692|Secondary|To Describe the Pace of Platelet Recovery|Platelet engraftment was defined as the first day of platelet counts more than 50,000/uL for 7 consecutive days without transfusions|180 days post transplant||||days||Full Range|Median
1218746|NCT00744692|Secondary|To Evaluate the Pace of Immune Reconstitution.|Immune reconstitution after RIC in UCBT was described. CD4 count is a standard measure of immune reconstitution and is described here. Additional data is available upon request.|1 year post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of Immune reconstitution endpoint. CD4 count is reported here.|||cells/uL||Full Range|Median
1218747|NCT00744692|Secondary|To Describe the Pace of Neutrophil Recovery|Neutrophil recovery was defined as the first day of an absolute neutrophil count (ANC) more than 500/uL for 3 consecutive days not secondary to granulocyte infusions|42 days post transplant||||days||Full Range|Median
1218748|NCT00744692|Primary|Determine the Feasibility of Attaining Acceptable Rates of Donor Cell Engraftment (>25% Donor Cells at 180 Days) Following RIC Regimens in Children < 21 Years Receiving UCBT for Non-malignant Disorders.|Determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor cells at 180 days) following reduced intensity conditioning regimens in children < 21 years receiving cord blood transplant for non-malignant disorders.|180 days post transplant|Of the 22 patients enrolled, 18 patients were alive at 180 days, the time-point for primary end point|||% of participants|||Number
1218749|NCT00744653|Secondary|Safety and Toxicity||up to 1 year|per protocol|||adverse events|Participants||Number
1218750|NCT00744653|Secondary|Participants With Objective Response Evaluated With PET/CT|Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.|3, weeks, 8 weeks, and up to 6 months after treatment|per protocol|||participants|||Number
1218751|NCT00744653|Primary|Clinical Measure of Lesion Size.|Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size|up to one year|Based on Simons optimal design for phase II trials, 25 evaluable patients were to be included and treated.|||Participants|||Number
1218752|NCT00744627|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set.|||participants|||Number
1218753|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218754|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218755|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218756|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218757|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218787|NCT00744497|Other Pre-specified|Number of Participants With Abnormal Results in Urinalysis|Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment.|||Participants|||Number
1218758|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218759|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218760|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218761|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218762|NCT00744627|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression-Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218763|NCT00744627|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1218764|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218765|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1218766|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2 and 4|"Full analysis set where Baseline data were available. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218767|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218768|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1 and 4|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218769|NCT00744627|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1218770|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1218771|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1218772|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.|||percentage of participants|||Number
1218773|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1218808|NCT00744328|Secondary|To Evaluate the Durability of Maternal Response to Estradiol, Sertraline, and Placebo in a Continuation Phase Through the Time the Infant is Assessed at 6.5 Months of Age.||yearly|||||||
1218809|NCT00744328|Secondary|Infant Serum Concentrations of Estradiol in 3 Treatment Arms||monthly|||||||
1218810|NCT00744328|Secondary|Infant Development Among 6.5 Month Old Children of Mothers With PPMD, as Assessed by Bayley Scales of Infant Development||yearly|||||||
1218774|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1218775|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1218776|NCT00744627|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1218777|NCT00744523|Secondary|Access Site Adverse Events|Number of subjects with adverse events at the percutaneous access site as a result of the index procedure, including bruising, hematoma and bleeding requiring treatment by transfusion of blood products, surgical repair, ultrasound compression or thrombin injection.|Index Procedure through Hospital Discharge||||participants|||Number
1218778|NCT00744523|Secondary|Target Lesion Revascularization at 30 Days|Number of subjects with any repeat invasive procedure, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase lumen diameter inside or within 10 mm of the previously treated lesion.|Up to 30 days after the procedure was performed||||participants|||Number
1218779|NCT00744523|Secondary|Restenosis at 30 Days|Number of subjects with re-narrowing of the lesion at 30 days as defined as a >= 50% stenosis measured by duplex ultrasound scan.|Up to 30 days after the procedure was performed||||participants|||Number
1218780|NCT00744523|Secondary|Procedural Success|"Number of subjects with technical success without the occurrence of any MACCE or unresolved antegrade flow blockage intolerance during the index hospitalization.~Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure through hospital discharge||||participants|||Number
1218781|NCT00744523|Secondary|Technical Success|"Number of subjects with device success and the ability to successfully implant a carotid stent and obtain a residual stenosis < 30% during the index procedure(as evaluated by the angiographic core laboratory).~Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure|Roll-In participants were analysed on the number of roll-in cases performed. Pivotal subjects were analysed as Intention To Treat (ITT).|||participants|||Number
1218782|NCT00744523|Secondary|Device Success|Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.|The entire duration of the index procedure|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria who were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.|||participants|||Number
1218783|NCT00744523|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure.|Number of subjects with one or more Major Adverse Cardiac and Cerebrovascular Events through 30 days after the procedure. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.|Up to 30 days after the procedure was performed|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.|||participants|||Number
1218784|NCT00744497|Other Pre-specified|Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study|BL=baseline; OS=on-study|At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated|All participants who were randomized to receive any treatment|||Participants|||Number
1218785|NCT00744497|Other Pre-specified|Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable|||Participants|||Number
1218786|NCT00744497|Other Pre-specified|Number of Participants by Maximal On-study Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable|||Participants|||Number
1218788|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0–10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0–6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment|||Participants|||Number
1218789|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology|Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment|||Participants|||Number
1218790|NCT00744497|Other Pre-specified|Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. AEs of Special Interest=recognized events in other agents within this drug class or events for which safety data from nonclinical and clinical studies with dasatinib indicate that careful evaluation is warranted. Drug-related=having certain, probable, possible, or missing relationship to study drug. Drug-related AEs of Special Interest are identified by the medical and safety representatives of the sponsor based on MedDRA preferred terms or laboratory data. ANC=absolute neutrophil count.|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment|||Participants|||Number
1218791|NCT00744497|Other Pre-specified|Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment|||Participants|||Number
1218792|NCT00744497|Secondary|Percentage of Participants With a Reduction in Pain Intensity From Baseline|The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire.|At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants with a baseline pain intensity of 2 or greater|||Percentage of participants||95% Confidence Interval|Number
1218793|NCT00744497|Secondary|Time to Prostate Specific Antigen (PSA) Progression|PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized.|From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
1218794|NCT00744497|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization.|From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
1218795|NCT00744497|Secondary|Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline|The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal.|At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants who entered the study with baseline urinary N-telopeptide values higher than the upper limit of normal (ULN), or ≥60 nmol/mmol creatinine, if ULN was missing|||Percentage of participants||95% Confidence Interval|Number
1218796|NCT00744497|Secondary|Time to First Skeletal-related Event (SRE)|Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized.|From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
1218797|NCT00744497|Secondary|Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present.|At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)|Participants with at least 1 target lesion at baseline|||Percentage of participants||95% Confidence Interval|Number
1218798|NCT00744497|Primary|Overall Survival: Time From Randomization to Date of Death|Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive.|From randomization to death or date of last contact (maximum reached: 45 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
1218799|NCT00744380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|The HADS consists of 14 questions, seven for anxiety and seven for depression. Each item is scored from 0 to 3, with a cut-off cumulative score of 11 for both subscales indicative of anxiety or depression. This scoring tool has been used for 30 years, possesses excellent reliability and validity, and avoids reliance conditions that are also common somatic symptoms of illness such fatigue, insomnia, and hypersomnia. The maximum score for each subscale is 21 with a maximum possible cumulative score of 42. The minimum score for each subscale is 0. The minimum cumulative score is 0|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the HADS were provided the assessment. Seven subjects were excluded.|||units on a scale||Standard Deviation|Mean
1218800|NCT00744380|Secondary|Manifestations of Acute Stress Disorder by Impact of Event Scale - Revised (IES-R)|The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately often,” 3 = “quite a bit,” and 4 = “extremely often.” The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the IES-R were provided the assessment. Seven subjects were excluded.|||units on a scale||Standard Deviation|Mean
1218801|NCT00744380|Secondary|Duration of Study Drug Administration||Duration of ICU stay, up to 24 weeks||||days||Inter-Quartile Range|Median
1218802|NCT00744380|Secondary|ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)|The ICU-SEQ assesses patient recall of their ICU experience. The ICU-SEQ assesses both psychological (e.g. fearfulness, anxiety) and physical (e.g. pain, difficulty breathing) perceptions of ICU patients who have received mechanical ventilation. It consists of 29 potentially stressful experiences with seven items specifically addressing the endotracheal tube. The extent that patients are bothered by each item is scored on a five point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately,” 3 = “quite a bit,” and 4 = “extremely.” The cumulative score is an integer interpreted as interval data with higher scores indicating greater stressful experiences associated with the ICU. The minimum score is 0 and the maximum score possible is 116.|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the ICU-SEQ were provided the assessment. Seven subjects were excluded.|||units on a scale||Full Range|Median
1218803|NCT00744380|Secondary|Sedation-related Adverse Effects||Duration of ICU stay, up to 24 weeks||||participants|||Number
1218804|NCT00744380|Secondary|The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)|The Riker sedation-agitation score (range 1-7) and PABS (range 0-10) are assessed hourly by the bedside nurse. Riker scores assess restlessness and cooperation. Riker scores of 5 – 7 indicate agitation, 3 - 4 represent adequate sedation and 1 - 2 represent excessive sedation. PABS assessments include domains of restlessness, muscle tone, vocalization, consolability, and facial expressions. PABS assessments of 0 represent no pain, 1 - 3 represent mild pain, 4 - 6 represent moderate pain, and ≥ 7 represent severe pain.|Duration of ICU stay, for up to 24 weeks||||percentage of assessments while on study|||Number
1218805|NCT00744380|Secondary|Cumulative Doses of Conventional Sedatives and Analgesics||Duration of ICU stay, for up to 24 weeks||||mg||Inter-Quartile Range|Median
1218806|NCT00744380|Primary|Time From Study Drug Initiation to Tracheal Extubation||Duration of ICU stay, for up to 24 weeks|The analysis only includes patients successfully extubated for at least 72 hours. Eight subjects were excluded.|||days||Inter-Quartile Range|Median
1218807|NCT00744328|Secondary|To Explore the Relationship of Remission and Response to the Subjects’ Serum Levels of Estradiol.||Monthly|||||||
1218811|NCT00744328|Primary|To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29|Depression was assessed with the Structured Interview Guide for the Hamilton Depression Rating Scale - Atypical Depression Symptoms Version (SIGH-ADS29). The scale incorporates the 17 and 21-item Hamilton Rating Scales for Depression (HRSD) as well as 8 atypical symptoms of depression. Scores range from 0 to 90, where a higher score corresponds to a higher level of depressive symptomatology.|Week 8|Analyses presented are Last Observation Carried Forward. For women who completed the 8 week trial the percent change was measured from baseline to week 8. For non-completers, the percent change was measured from baseline to last observation.|||percentage change in SIGH-ADS29 Score||Standard Deviation|Mean
1218812|NCT00744263|Other Pre-specified|Percentage of Participants With Newly Diagnosed Chronic Medical Condition|Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.|From 1 month after vaccination up to 6 months after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.|||percentage of participants|||Number
1218813|NCT00744263|Other Pre-specified|Percentage of Participants Who Died|Deaths collected throughout the case acquisition period were presented.|From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Safety population included all participants who received study vaccine and who had any safety data.|||percentage of participants|||Number
1218814|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination|Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.|Within 7 days after vaccination|Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.|||percentage of participants||95% Confidence Interval|Number
1218815|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination|Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.|Within 7 days after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.|||percentage of participants||95% Confidence Interval|Number
1218816|NCT00744263|Secondary|Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases|VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).|Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
1218817|NCT00744263|Secondary|Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature >38.0 degrees C or <36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15% bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.|Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
1218876|NCT00743340|Primary|Number of Participants Who Had Access to, and Received the Intervention|This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.|Up to 586 weeks|Participants who were enrolled into the study and received study drug.|||Participants|||Count of Participants
1218818|NCT00744263|Primary|Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (>) 38.0 degrees Celsius (C) or less than (<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15 percent (%) bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).|Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
1218819|NCT00744237|Secondary|Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5|[visit 5(week 0) and visit 14(week 26)]||||Unit on a scale||Standard Deviation|Mean
1218820|NCT00744237|Primary|Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26|Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.|visit 5(week 0) and visit 14(week 26)||||Percentage||Standard Deviation|Mean
1218821|NCT00744211|Other Pre-specified|Number of Other Adverse Events By Type|Other (non-serious) Adverse Events (reported by arm/group)|up to 24-hours post-CPB||||events|||Number
1218822|NCT00744211|Other Pre-specified|Sitaxsentan Levels|Sitaxsentan levels (microg/mL)|0, 6, 12 and 24 hours post-CPB||||microg/mL||Standard Deviation|Mean
1218823|NCT00744211|Secondary|Plasma Endothelin-1|Plasma Endothelin-1 (fmol/mL)|Baseline, 0, 6, 12 and 24 hours post-CPB||||fmol/mL||Standard Deviation|Mean
1218824|NCT00744211|Primary|Pulmonary Vascular Resistance|Pulmonary Vascular Resistance (d.s.cm-5)|Baseline, 0, 6, 12 and 24 hours post-cardiopulmonary bypass (CPB)||||dyne*second/centimeter˄5||Standard Deviation|Mean
1218825|NCT00744055|Primary|Clinician-Administered PTSD Scale|Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD|12 weeks||||units on a scale||Standard Deviation|Mean
1218826|NCT00744055|Primary|Number of Drinking Days|Using the Timeline Follow Back method, a calendar method for assessing drug and alcohol use|12 weeks||||days||Standard Deviation|Mean
1218827|NCT00744042|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||h*U/L||Standard Deviation|Mean
1218828|NCT00744042|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Time at maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||hour||Standard Deviation|Mean
1218829|NCT00744042|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax)|Maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose)|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||U/L||Standard Deviation|Mean
1218830|NCT00744042|Primary|Change in Rickets Severity From Baseline to Week 24, Based on Assessment of Skeletal Radiographs Using Radiologic Global Impression of Change (RGI-C)|"A 7-point RGI-C (Radiographic Global Impression of Change) score was used to rate change in rickets severity. Scores ranged from -3 (severe worsening of rickets) to +3 (complete healing of rickets). Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings. Average scores were derived for each patient at each assessment."|24 weeks|ITT (intention to treat)|||Units on a scale||Full Range|Median
1218831|NCT00743730|Secondary|Parent Satisfaction With the Administration Technique|Parents were asked “Overall, how satisfied were you with the pain relief your child received after surgery?” Response options were: 1. Very Dissatisfied, 2. Dissatisfied, 3. Satisfied, 4. Very Satisfied. Responses were scored on a 1-4 scale, with Very Dissatisfied = 1; Dissatisfied = 2; Satisfied = 3; Very Satisfied = 4.|parents, once at the end of study|Data was obtained from parents who completed the satisfaction survey|||units on a scale||Standard Deviation|Mean
1218832|NCT00743730|Secondary|Number of Patients Requiring Naloxone for Respiratory Depression|Number of patients requiring naloxone for respiratory depression (our most important side effect)|Daily, for up to 3 days||||Participants|||Count of Participants
1218833|NCT00743730|Primary|Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale|Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported.|First 24 hours on study||||units on a scale||Inter-Quartile Range|Median
1218834|NCT00743717|Primary|Knee Score at 2 Years Post Operation|"The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess success."|within 2 years||||units on a scale||Full Range|Mean
1218835|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose||28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
1218836|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose||28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
1218837|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series||28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
1218838|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose|Antibody geometric mean titers as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
1218839|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Toddler Dose|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all subjects with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
1218840|NCT00743652|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
1218841|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218842|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218843|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218906|NCT00742885|Secondary|Number of Subjects Reporting Any Medically-significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.|During the 182-day (Days 0-181) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218844|NCT00743652|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1218845|NCT00743652|Other Pre-specified|GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1218846|NCT00743652|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1218847|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218848|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218849|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218850|NCT00743652|Other Pre-specified|Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC|In order to assess the impact of 13vPnC on the incidence of IPD in the Yukon Kuskokwim (YK) Delta region, the Centers for Disease Control and Prevention (CDC) Arctic Investigation Program (AIP) accessed IPD data through evaluation of ongoing statewide IPD surveillance in Alaska. The CDC’s AIP followed IPD (including serotype and vaccination history) to show whether identified cases of IPD received Prevnar, 13vPnC, or both. These data were combined with statewide data and used to identify the overall trend in IPD in the YK Delta region after introduction of 13vPnC.|Baseline to 6 months after last vaccination|Safety Population|||Participants|||Number
1218851|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2|Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
1218852|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1|Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
1240029|NCT00582166|Secondary|Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0|To record the toxicities associated with this regimen.|Up to 5 years and 9.5 months||||Participants|||Count of Participants
1218853|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
1218854|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population: all participants who received at least 1 dose of 13vPnC; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
1218855|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218856|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218857|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218858|NCT00743652|Secondary|Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218859|NCT00743652|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218860|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218874|NCT00743431|Primary|Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)|"Definitions in assessment of adverse event severity:~Mild: awareness of sign, symptom, or event, but easily~tolerated.~Moderate: discomfort enough to cause interference with usual~activity and may warrant intervention.~Severe: incapacitating with inability to do usual activities or~significantly affects clinical status, and warrants~intervention."|The observational program was conducted over a period of 2 years|Intent-to-treat (ITT) (N=214). This is also the Safety population.|||Events|||Number
1218932|NCT00742625|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||months||95% Confidence Interval|Median
1218861|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population: received treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1218862|NCT00743574|Primary|AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months|AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT|3 months|Number determined by all participants who completed all interventions and procedures|||mg/min/120min||Standard Deviation|Mean
1218863|NCT00743574|Primary|AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months|Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT|3 months|Number determined by completion of all study interventions and procedures|||µIU/ml/120min||Standard Deviation|Mean
1218864|NCT00743574|Primary|Fasting Glucose Levels at Completion of Treatment, at 3 Months|Fasting glucose levels drawn after 3 months completion during oral GTT|3 months|Number determined based on all interventions and procedures completed.|||mg/dl||Standard Deviation|Mean
1218865|NCT00743574|Primary|Fasting Insulin Levels at Study Completion After 3 Month Treatment|Fasting insulin levels at study completion after 3 month treatment|3 months intervention|Number determined by all those who completed all interventions and procedures.|||µIU/ml||Standard Deviation|Mean
1218866|NCT00743574|Primary|Participants Were Assessed at Study Completion After 3 Month Treatment|Fasting HbA1C levels at study completion after 3 month treatment|Completion|Number determined by those who completed all interventions and procedures.|||percentage||Standard Deviation|Mean
1218867|NCT00743574|Secondary|Serum Levels of C-reactive Protein at Completion of 3 Months Treatment Compared to Baseline.|Serum levels of C-reactive protein upon completion, at 3 months|3 months|All subjects who completed treatment for 3 months|||mg/L||Inter-Quartile Range|Median
1218868|NCT00743509|Secondary|Median Overall Survival Time|Median overall duration of survival.|48 weeks|All patients who completed at least one 28 day cycle|||days||95% Confidence Interval|Median
1218869|NCT00743509|Primary|Number of Patients Alive Without Disease Progression|Patients who were evaluable for response to therapy, alive and without evidence of sarcoma disease progression. Target lesions followed were lesions that had progressed by World Health Organization (WHO) criteria. Disease progression is defined as a greater than or equal to 25% increase in the sum of the product of target lesions, or unequivocal progression of non-target lesions or the appearance of new tumor lesions >10mm.|6 months|Patients that tolerated and completed at least one 28 day cycle of therapy were considered evaluable|||participants|||Number
1218870|NCT00743483|Primary|The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)|"The absolute difference between baseline and treatment CFA, i.e. the change from the baseline level.~CFA was calculated as follows 100 x ((fat consumed - fat excreted)/fat consumed).~Fat consumed was determined from the weight of fat of the dietary intake during a 72 hour period during the final 3 days of the baseline and treatment period.~Fat excreted was determined from stool collected during the 72-hour periods and analyzed for fat using the Van de Kamer method.~The unit of CFA is %"|Final 3 days of baseline and treatment period|Per protocol|||% CFA||Standard Deviation|Mean
1218871|NCT00743444|Secondary|Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.|The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here.|0-12 hours post first dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 1 patient was excluded from the pharmacokinetic analysis due to error in dose administration at dose 2.|||μmol*hours / L||Standard Deviation|Geometric Mean
1218872|NCT00743444|Secondary|Total Number Reflux Episodes 0-24 Hours Post First Dose|Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.|0-24 hours|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from this analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 2 due to insufficient impedance/pH recording time.|||Episodes||95% Confidence Interval|Geometric Mean
1218873|NCT00743444|Primary|Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose|"The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133).~The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment."|0-3 hours post meal, post third dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from the primary analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 1 due to low LESP, 1 due to multiple swallowing.|||Relaxations||95% Confidence Interval|Geometric Mean
1218875|NCT00743366|Primary|Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase|"This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke.~Over each 3 day period, the puffs chosen by each participant is averaged for a single value."|Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)||||Puffs||Standard Error|Mean
1218877|NCT00743288|Primary|Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan|Responses were evaluated according to criteria modified from those developed by Blade et al., 1998 The reference point for evaluating response improvement is the baseline. This baseline reference point is also valid when a patient has already achieved a response and transitions through into a better response grade.|24 months||||participants|||Number
1218878|NCT00743288|Primary|MTD|Phase 1: to determine MTD of melphalan in combination with panobinostat to be used in the Phase 2 portion of the study|12 months||||mg/kg melphalan|||Number
1218879|NCT00743288|Primary|Maximum Tolerated Dose (MTD)|Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study|12 months|MTD for Melphalan and Panobinostat was reached in the cohort of 6 participants who received 20 mg/daily LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1 of each cycle. Three additional patients were enrolled as part of the phase 2 expansion.|||mg LBH589|||Number
1218880|NCT00743288|Secondary|Time to Progression||Time from the start of treatment to progressive disease|All cohorts were analyzed|||months||Full Range|Median
1218881|NCT00743288|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death|Only three patients had responses.|||months||Full Range|Median
1218882|NCT00743275|Primary|Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)|Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation|21 days post-vaccination|Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Percentage of Participants|||Number
1218883|NCT00743275|Primary|Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)|Seroprotection was defined as post-vaccination titer value of ≥ 1:40.|21 days post-vaccination|Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Percentage of Participants|||Number
1218884|NCT00743275|Primary|Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation||Day 0 and 21 days post-vaccination|Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Titers||95% Confidence Interval|Geometric Mean
1218885|NCT00743275|Primary|Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering|Days 0-3 post-vaccination|Safety profile was assessed in the intent-to-treat (ITT) population|||Participants|||Number
1218886|NCT00743262|Secondary|Device Life Time|Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)|one year||||days||Standard Deviation|Mean
1218887|NCT00743262|Secondary|Subjective Voice and Speech Quality|Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.|3 weeks||||units on a scale||Standard Deviation|Mean
1218888|NCT00743262|Primary|Short-term Feasibility Provox Vega 22.5 French|Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.|3 weeks||||Patients|||Number
1218889|NCT00743249|Secondary|Percentage of Subjects Retaining the Stent at Month 3|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|Month 3|Intent to treat|||Percentage of subjects|||Number
1218890|NCT00743249|Primary|Mean Retention Time|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|From baseline (Day 0) up to Month 3|Intent to treat|||Days||Standard Deviation|Mean
1218891|NCT00743197|Secondary|The Role and Function of Endothelial Progenitor Cells (EPCs) in the Presence of Proven Endothelial Dysfunction and the Response of EPCs to Medical Therapy for Endothelial Dysfunction.|no analyses were conducted due to the PI's departure from the institution; all work including analyses ceased upon departure- the study was not transferred with the PI. In addition, the study end points were based on changes between groups (treatment vs. usual care group) at 12 month follow up for both groups - none of the enrolled subjects made it to the final (month 12) visit.|1 year|||||||
1218892|NCT00743197|Primary|Effectiveness of Therapy Compared to Usual Care, in Those Women With Chest Pain (CP), Reversible Ischemia by Stress Testing and Nonobstructive Coronary Artery Disease (CAD) by Angiography Who Are Found to Have Coronary Endothelial Dysfunction (CED).|The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.|1 year|no analyses were conducted due to PI's departure from institution;all work including analyses ceased upon departure-the study was not transferred with the PI. In addition, study end points were based on changes between groups (treatment vs. usual care)at 12-mo follow up for both groups- none of the enrolled subjects completed the month 12 visit.|||participants|||Number
1218893|NCT00743145|Primary|Subjective Marijuana Effects|Subjective ratings of marijuana’s quality and effect (‘Strength', ‘Good Effect’, 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with a series of 100 mm long lines labeled ‘not at all’ at one end (0 mm) and ‘extremely’ at the other end (100 mm). Participants were instructed to indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement.|180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.||||units on a scale (0-100mm)||Standard Error|Mean
1218894|NCT00743119|Primary|Pain Tolerance|Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion).|Within each session lasting approximately 5 minutes, for a total of five sessions|All participants who completed the study (N=30) were included in the final analysis.|||seconds||Standard Error|Mean
1218895|NCT00743106|Secondary|Postoperative Creatinine (mg/dL)|assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4)|"immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"||||mg/dL||Standard Error|Mean
1218896|NCT00743106|Primary|Glomerular Filtration Rate (GFR) Percentage of Change From Baseline|Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.|percentage of change from baseline to post-operatively day 3||||percentage change||Standard Deviation|Mean
1218897|NCT00743093|Secondary|The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).||Days 1-3|A subset of the safety population was monitored for early detection of APAP-cys. This subset of subjects had APAP-cys measured at Days 1, 2, and 3 in addition to other protocol defined timepoints.|||participants|||Number
1218898|NCT00743093|Primary|The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.|ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40.|serial samples for 16-40 days|The total number of subjects completing the trial was used for analysis. Subjects who withdrew early were not included.|||participants|||Number
1218899|NCT00742963|Primary|Maximum Tolerated Dose (MTD) Measured of TH-302 When Used in Combination With Doxorubicin and Prophylactic Growth Factor Support in Subjects With Advanced Soft Tissue Sarcoma||Two years||||mg/m2|||Number
1218900|NCT00742924|Secondary|Prognostic Value of Bone Resorption Markers|Blood will be collected for quantification of c-telopeptide and urine will be collected for quantification of n-telopeptide.|At baseline and at weeks 13 and 36|||||||
1218901|NCT00742924|Secondary|Secondary Limiting Toxicity|"Secondary limiting toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor.~CTC AE version 4 hematologic toxicity will be based on time to blood count recovery to an ANC ≥ 1000/µL and platelet count ≥ 100,000/µL that delays definitive surgery by more than 2 weeks."|After week 13 to the end of protocol therapy|||||||
1218902|NCT00742924|Secondary|Event-free Survival|The EFS and survival functions will be estimated by the Kaplan-Meier methodology.|Time from study enrollment to disease recurrence, death without disease progression, diagnosis of a second malignant neoplasm, assessed up to 5 years|||||||
1218903|NCT00742924|Secondary|Histologic Response as Assessed in the Primary Tumor and in Resected Metastases|"Histologic response as graded according to the system of Huvos across all specimens resected at the time of local control in the primary tumor and in resected metastases.~The best response, as quantified by maximum necrosis grading according to the system of Huvos across all specimens resected at the time of local control, will be used to quantify the effect of Induction chemotherapy."|At definitive surgery planned for 12 weeks after the start of protocol therapy.|||||||
1218904|NCT00742924|Primary|Limiting Toxicity|"The occurrence of Limiting Toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor."|Enrollment through the first 12 weeks of therapy.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome|||participants|||Number
1218905|NCT00742885|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 181)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218933|NCT00742625|Secondary|Disease-free Survival|Disease-free survival (DFS) was measured as the interval from achievement of CR until relapse or death, regardless of cause. DFS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||months||95% Confidence Interval|Median
1218907|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|From Day 0 to Day 83 following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218908|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218909|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218910|NCT00742885|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm).|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218911|NCT00742885|Secondary|Number of Subjects With Any Normal or Abnormal Urine Values|Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218912|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218913|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218914|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218915|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges.|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1218916|NCT00742885|Secondary|Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies|"A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182.~The H5N1 vaccine strain included A/Indonesia antigen."|At Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
1218917|NCT00742885|Secondary|Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Titer||95% Confidence Interval|Geometric Mean
1218918|NCT00742885|Secondary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
1218919|NCT00742885|Secondary|Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Fold Increase||95% Confidence Interval|Geometric Mean
1218920|NCT00742885|Secondary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
1218921|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Titer||95% Confidence Interval|Geometric Mean
1218922|NCT00742885|Primary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1218923|NCT00742885|Primary|HI Antibody Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Fold Increase||95% Confidence Interval|Geometric Mean
1218924|NCT00742885|Primary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1218925|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1218926|NCT00742872|Primary|Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.||Within the first 8 weeks of treatment||||participants|||Number
1218927|NCT00742859|Secondary|Exposure-adjusted Incidence Rate of Any Bleeding (Major, Clinically Relevant Non-major, or Minimal)|The time to the first occurrence of any bleeding event. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.|A maximum of 1 year|All randomized patients who took at least 1 dose of study medication after randomization.|||Number of Patients per 100 Patient years||95% Confidence Interval|Number
1218928|NCT00742859|Primary|Exposure-adjusted Incidence Rate of Major or Clinically Relevant Non-major Bleeding Episode|The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.|A maximum of 1 year|All randomized patients who took at least 1 dose of study medication after randomization.|||Number of Patients per 100 Patient years||95% Confidence Interval|Number
1218929|NCT00742781|Primary|25(OH)D3 Serum Levels|25(OH)D3 levels before and after vitamin D supplementation.|6 months||||ng/ml 25(OH)D3||Standard Error|Mean
1218930|NCT00742781|Secondary|Health Improvement|International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.|6 months|Activity records for 14 participants were recorded at baseline and after vitamin D supplementation.|||units on a scale||Standard Error|Mean
1218931|NCT00742781|Primary|Crohn's Disease Activity Index|Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.|6 months||||units on a scale||Standard Error|Mean
1218934|NCT00742625|Primary|Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine|"DLTs were considered only during the first cycle of consolidation therapy and included grade 3 or 4 sensory or autonomic neuropathy, persistent grade 4 thrombocytopenia or neutropenia at day 42 in the absence of AML,any grade 4 or 5 nonhematologic toxicity, and any grade 3 nonhematologic toxicity (excluding neuropathy and toxicities secondary to neutropenia and sepsis) that did not resolve to grade 2 by day 42 unless attributable to persistent or recurrent AML. Grade 4 anorexia (requiring total parenteral nutrition) and grade 4 fatigue (requiring bed rest) were not considered DLTs.~Toxicity was graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale is as follows: grade 1: mild; grade 2: moderate; grade 3: Severe; grade 4: Life Threatening; grade 5: Death."|during consolidation cycle 1 (42 days)|Participants who were registered to bortezomib consolidation were included in the analysis.|||participants|||Number
1218935|NCT00742625|Primary|Remission Induction Response|"Response was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML)~A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction.~A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL).~A CRp is defined as a CR except platelets < 100,000 mL without need for transfusion."|2 months||||participants|||Number
1218936|NCT00742560|Secondary|Plasma Cell Myeloma Cytogenetic Subtype|Plasma cell myeloma cytogenetic subtype was assessed at the screening visit using standard karyotyping and/or fluorescence in situ hybridization. The number of participants in each cytogenetic risk category are provided: High Risk (International Staging System [ISS] stage II or III and t(4;14) or del(17p) abnormality); Standard Risk (not high or low risk); and Low Risk (ISS stage I or II and absence of t(4;14), del(17p) and 1q21 abnormalities AND age < 55).|Screening (up to 14 days prior to dosing)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
1218937|NCT00742560|Secondary|Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)|Treatment-emergent (post-dose) positive elotuzumab-specific ADA is differentiated from pre-existing (positive at the predose time point) positive elotuzumab-specific ADA. The percentage of participants with confirmed treatment-emergent ADA overall by dose is provided.|From screening through 60-day follow up period (up to 101 months)|All participants who received at least one dose of study drug and with at least one evaluable post-dose sample.|||percentage of participants|||Number
1218938|NCT00742560|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression or death. The distribution of PFS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the PFS distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1218939|NCT00742560|Secondary|Time to Progression (TTP)|TTP is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression. The distribution of TTP was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the TTP distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1218940|NCT00742560|Secondary|Duration of Response|Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. The distribution of duration of response was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the duration of response distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1218941|NCT00742560|Secondary|Serum Half-life (t1/2) of Elotuzumab|The serum half-life of a drug (t1/2, measured in hours) is the time necessary to reduce the plasma concentration by half. The t1/2 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1218942|NCT00742560|Secondary|Volume of Distribution (V) of Elotuzumab|Volume of distribution (V, measured in L/kg) is the hypothetical volume of body fluid that would be required to dissolve the amount of drug needed to achieve the same concentration in the blood. The V of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1218943|NCT00742560|Secondary|Systemic Clearance (CL) of Elotuzumab|Systemic clearance (CL, measured in mL/kg/hr) is a measure of the efficiency with which a drug is irreversibly removed from the body. The CL of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1219301|NCT00739102|Secondary|Index Limb Amputation at 30-day Follow up|Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.|30 day|Active subjects in the Modified ITT population at 30 days post procedure|||participants|||Number
1218944|NCT00742560|Secondary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab|The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1218945|NCT00742560|Secondary|Maximum Serum Concentration (Cmax) of Elotuzumab|The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1218946|NCT00742560|Secondary|Mean Serum Concentrations of Elotuzumab During Cycle 1|Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose.|Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)|Safety population: All randomized participants who received at least 1 dose of study drug, with evaluable data at given time point.|||μg/mL||Standard Deviation|Mean
1218947|NCT00742560|Secondary|Number of Participants With Infusion Reactions|During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0).|Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
1218948|NCT00742560|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
1218949|NCT00742560|Secondary|Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)|ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).|From first dose of elotuzumab until 60 days following the last infusion (or before initiation of new therapy), up to 100.5 months|Safety population: All randomized participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1218958|NCT00742508|Primary|Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8|There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
1218950|NCT00742560|Primary|Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)|ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).|From date of randomization until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1218951|NCT00742560|Primary|Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1)|MTD was determined by testing increasing doses up to 20 mg/kg once daily dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (dose limiting toxicity [DLT]) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria for Adverse Events (CTCAE) Grade 4 neutropenia in specific conditions, platelets < 10,000 cells/mm^3 that do not recover to 25,000 cells/mm^3; and specific non-hematologic/biochemical toxicities CTCAE Grade 3 or 4 (except fatigue and Grade 3 infections); CTCAE version 3.0 were used.|4 weeks|All participants in the safety population (all randomized participants who received at least 1 dose of study drug) in the escalation cohorts (Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone [Phase 1]; Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone [Phase 1]; and Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone [Phase 1]).|||mg/kg|||Number
1218952|NCT00742508|Secondary|Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8|Left ventricular ejection fraction (LVEF) is a marker of left ventricular systolic function and was measured by echocardiogram. It is shown as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.|||percentage||Standard Deviation|Mean
1218953|NCT00742508|Secondary|Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8|Brain natriuretic peptide is a surrogate marker of the severity of heart failure and was measured by a central laboratory.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.|||ng/L (nanogram per Liter)||Standard Deviation|Mean
1218954|NCT00742508|Secondary|Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8|The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of. 4 classes: I, no resulting limitations on physical activity (PA); II, slight limitations on PA; III, marked limitations on PA; IV, inability to carry out any PA without discomfort. The number of participants with any change from Baseline in the NYHA Functional Class at Week 8 was calculated. Improved=class at the visit is decreased compared to baseline class, Unchanged=class at the visit is stable, Worsened=class at the visit is increased compared to baseline class.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
1218955|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|PD Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||beats per minute||Standard Error|Mean
1218956|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||millimeters of mercury (mmHg)||Standard Error|Mean
1218957|NCT00742508|Primary|Cardiothoracic Ratio at Baseline and Week 8|Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage||Standard Deviation|Mean
1219302|NCT00739102|Secondary|Death at 12-month Post Procedure||12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1218959|NCT00742508|Primary|Mean Change From Baseline in Weight at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||kilograms (kg)||Standard Deviation|Mean
1218960|NCT00742508|Primary|Mean Change From Baseline in Heart Rate at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||beats per minute||Standard Deviation|Mean
1218961|NCT00742508|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1218962|NCT00742508|Primary|Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8|Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
1218963|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Volume at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||femtoliters (fL)||Standard Deviation|Mean
1218964|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||picograms (pg)||Standard Deviation|Mean
1218965|NCT00742508|Primary|Mean Change From Baseline in Red Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||tebi (2 to the power of 40)/liter (Ti/L)||Standard Deviation|Mean
1218966|NCT00742508|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||gibi (2 to the power of 30)/liter (Gi/L)||Standard Deviation|Mean
1218967|NCT00742508|Primary|Mean Change From Baseline in Hematocrit at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||proportion of 1 (SI)||Standard Deviation|Mean
1218968|NCT00742508|Primary|Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||grams per liter (g/L)||Standard Deviation|Mean
1218969|NCT00742508|Primary|Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage of each WBC type in WBC count||Standard Deviation|Mean
1218970|NCT00742508|Primary|Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage of Total Creatine Kinase||Standard Deviation|Mean
1218971|NCT00742508|Primary|Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1218972|NCT00742508|Primary|Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||micromoles per liter (umol/L)||Standard Deviation|Mean
1219303|NCT00739102|Secondary|Death Rate at 30-day Post Procedure||30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
1218973|NCT00742508|Primary|Mean Change From Baseline in Amylase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||units per liter (U/L)||Standard Deviation|Mean
1218974|NCT00742508|Primary|Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||international units per liter (IU/L)||Standard Deviation|Mean
1218975|NCT00742508|Primary|Mean Change From Baseline in Albumin and Total Protein at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||grams per liter (g/L)||Standard Deviation|Mean
1218976|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||millimeters of mercury (mmHg)||Standard Error|Mean
1218977|NCT00742508|Secondary|Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Time of maximal plasma concentration (tmax) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 in group F who gave samples at Week 8 in the CRV-IR group; total of 15 participants, including 4 in group C who gave samples at Week 8 in the SK&F-105517-D group|||hours||Full Range|Median
1218978|NCT00742508|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Area under the plasma concentration versus time curve from time zero to 24 hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|Pharmacokinetic (PK) Parameter Population: all participants who received the study drug at each dose level and provided sufficient PK concentration data and the data for estimation of PK parameters (total of 13 participants, 3 gave samples at Week 8 in CRV-IR group; total of 15 participants, 4 gave samples at Week 8 in the SK&F-105517-D group)|||hours * nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1218979|NCT00742508|Secondary|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 active Metabolite (SB-203231) were measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 who gave samples in group F at Week 8 in CRV-IR group; total of 15 participants, including 4 who gave samples at Week 8 in the SK&F-105517-D group)|||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1218980|NCT00742508|Primary|Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)|Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.|Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D|Safety Population: all participants who received at least one dose of the investigational product|||participants|||Number
1218981|NCT00742417|Secondary|Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)|Percentage of patients with improved perfusion at the end of the study compared to their initial perfusion. Frontal, parietal and temporal lobes were evaluated from the quantified NeuroGam images. This rendered parametric images showed brain alterations with more than 2 standard deviations with respect to a normal data base. Initial parametric images were compared to the final ones and it was considered perfusion improvement those patients that showed less stretch and/or defect intensity.|End of study|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients|||percentage of participants|||Number
1218991|NCT00742391|Primary|Patients With Complete Clearance of Actinic Keratosis (AKs)|Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population|||Participants|||Number
1218982|NCT00742417|Secondary|Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.|Structural changes in volume of the hippocampus, posterior cingular area, and other associated areas by Magnetic Resonance Imaging (MRI). Three measurements were made (week -2 or -1, 20 and 44). It was measured the variations versus the baseline.|Week 00 (baseline), week 20 and week 44|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients|||cubic centimetres (cc)||Standard Deviation|Mean
1218983|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).|"Change in the cognitive, functional and neuropsychiatric scores and overall development.~ADCS-ADL: Alzheimer’s Disease Cooperative Study/Activities Of Daily Living (23 questions describing daily activity of the subject and requests the informer to describe the actions or behaviors observed. Increased autonomy associated to higher scores, maximum of 78 points and minimum of 0)~NPI: Neuropsychiatric Inventory Questions (12 symptom domains scored by frequency [range=0 to 4, higher values being more frequent] and severity [range=1 to 3, higher values being more severe], total score is sum of frequency x severity of all domains)~CDR-Sb: Clinical Dementia Rating (range=0 to 3, higher values being more severe)~ADCS-CGIC: Alzheimer’s Disease Cooperative Study/Clinical Global Impression of Change (7-point Likert scale, 0=not assessed, 1=marked improvement, 2=moderate improvement, 3=minimal improvement, 4=no change, 5=minimal worsening, 6=moderate worsening and 7=marked worsening)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||units on a scale||Standard Deviation|Mean
1218984|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)|"Change in the cognitive, functional and neuropsychiatric scores and overall development.~MMSE: Mini Mental State Examination Score (range = 0 to 30, with lower values indicating impairment)~ADAS-Cog: Alzheimer’s Disease Assessment Scale, Cognitive Subscale (range = 0 to 70, with higher values indicating impairment)~NPS (Neuropsychological battery): •SDMT (Symbol Digit Modalities Test, range = 0 to 110, with lower values indicating impairment), •SVF (Semantic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •PVF F, A and S (Phonetic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •BNT (Boston Naming Test, with a maximum of 15 pictures), •RAVLT (Rey Auditory Verbal Learning Test, with 15 words the patient should listen and remind)~CSDD (Cornell Scale for Depression in Dementia, 0 = none; 1 =mild or intermittent; 2 = severe)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||units on a scale||Standard Deviation|Mean
1218985|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (Innotest).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using Innotest commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
1218986|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
1218987|NCT00742417|Secondary|Aβ1−40 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−40 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
1218988|NCT00742417|Secondary|P-Tau and Tau CSF Levels Throughout the Study.|Levels of Tau and P-tau in CSF throughout the treatment phase and the follow-up phase (week 44).|Baseline, week 02, week 08, week 20, week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
1218989|NCT00742417|Primary|Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.|Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.|Baseline and up to week 44|The efficacy analyses were performed with the full analysis set (FAS) population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions (or sham procedures) during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||95% Confidence Interval|Least Squares Mean
1218990|NCT00742391|Secondary|Patients With Partial Clearance of Actinic Keratosis (AKs)|Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.|baseline and 57 days|Intention to treat population|||participants|||Number
1240130|NCT00581048|Secondary|Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL||baseline to after 16-18 weeks of treatment with vitamin E daily||||UI/ml||Inter-Quartile Range|Median
1218992|NCT00742326|Secondary|Change in Insulin Resistance in HIV- and HCV-infected Patients With Steatosis Compared to Placebo|Change in Glucose Area Under the Curve from standard oral glucose challenge ( baseline to 2 hours): Week 48 - Baseline values|48 weeks|One subject in the placebo arm was discontinued due to health issues and does not have a 48 week OGTT available|||mg*120 minutes/dL||Standard Deviation|Mean
1218993|NCT00742326|Primary|Change in Hepatic Steatosis and Hepatic Inflammation/Fibrosis in HIV/HCV Co-infected Patients With Steatosis.|Change in hepatic steatosis and hepatic inflammation/fibrosis in HIV/HCV co-infected patients with steatosis. Change in Hepatic Fat Content measured by MR spectroscopy: 48 weeks compared to Baseline|48 weeks|Two subjects (one in each group) did not have a follow up MRI for comparision to baseline. One developed claustrophobia and could not tolerate MRI and one was discontinued from study due to other illnesses.|||percentage of hepatic fat on MRS||Standard Deviation|Mean
1218994|NCT00742313|Primary|Number of Participants With Decreased Bleeding|The number of participants with less than expected bleeding (bleeding typically expected for the vein grafting procedure) at the surgical site. Blood was collected in the Blake drain of the EVH wound bed treated with FloSeal MatrixFloSeal Matrix™in the tunnel of the endoscopically harvested Greater Saphenous vein.|14 days|Six participants were not analyzed due to early termination of study|||participants|||Number
1218995|NCT00742274|Primary|Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation|"Subjects with any of the following met this composite outcome:~partial/no false lumen thrombosis~aortic rupture~aortic dilatation~lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image)"|1 year|Intent to Treat (ITT)|||participants|||Number
1218996|NCT00742235|Primary|Baseline 25-OH Vitamin D Level||Baseline||||ng/ml||Inter-Quartile Range|Median
1218997|NCT00742235|Primary|hCAP18 Levels||Baseline||||ng/ml||Standard Deviation|Mean
1218998|NCT00742209|Other Pre-specified|Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17|"Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting Very Satisfied (scale value = 1) or Satisfied (scale value = 2) on the scale."|Week 17|ITT Population|||Percentage of Patients|||Number
1218999|NCT00742209|Other Pre-specified|Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)|Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.|Week 17|ITT Population|||Hours||Standard Error|Mean
1219000|NCT00742209|Other Pre-specified|Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17|The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.|Week 17|ITT Population|||Points on a scale||Standard Error|Mean
1219001|NCT00742209|Other Pre-specified|Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17|The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.|Baseline and Week 17|ITT Population|||units on a scale||Standard Error|Mean
1219002|NCT00742209|Secondary|Number of Participants Who Were “Much Improved” or “Very Much Improved” (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17|"The CGIC is a single question measured on a 7-point Likert Scale. (1 = “very much improved”; 2= much improved, and 7 = “very much worse”) designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'."|Week 17|ITT Population|||Participants|||Number
1219003|NCT00742209|Secondary|Number of Participants Who Were “Much Improved” or “Very Much Improved” on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17|"The PGIC is a single question measured on the 7-point Likert Scale (1 = “very much improved”; 2 = much improved; 7 = “very much worse”). A responder is defined as being very much improved or much improved."|Week 17|ITT Population|||participants|||Number
1219004|NCT00742209|Secondary|Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods|A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.|Baseline to the Last 4 weeks of treatment|ITT Population|||percentage of participants|||Number
1219005|NCT00742209|Secondary|Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia|The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Percentage of MA with migraine symptoms||Standard Error|Mean
1219050|NCT00741611|Secondary|Number of Participants With Acute Procedural Success in Mesh Treated Patients.|Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter|During the mesh ablation procedure|All mesh treated patients.|||participants|||Number
1219006|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use|The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Migraine Medication Doses||Standard Error|Mean
1219007|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use|The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Days||Standard Error|Mean
1219008|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use|The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Migraine Medication Dose||Standard Error|Mean
1219009|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered|The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Medication Doses Admin.||Standard Error|Mean
1219010|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use|The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Days||Standard Error|Mean
1219011|NCT00742209|Secondary|Change From Baseline in the Mean Peak Migraine Pain Severity|Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Scores on a Scale||Standard Error|Mean
1219012|NCT00742209|Secondary|Change From Baseline in the Mean Migraine Attack Duration|The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Hours||Standard Error|Mean
1219013|NCT00742209|Secondary|Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)|A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Headache Periods (MHP)||Standard Error|Mean
1219014|NCT00742209|Secondary|Adjusted Mean Change From Baseline in the Number of Migraine Attacks|A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Attacks||Standard Error|Mean
1219015|NCT00742209|Secondary|Mean Change From Baseline in the Number of MHD in All Study Phases|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Headache Days (MHD)||Standard Error|Mean
1219016|NCT00742209|Primary|Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|Intent to treat (ITT). There were 3 subjects who were randomized but did not take investigational product, and, therefore were not included in the Safety, ITT, or Per Protocol (PP) population.|||Migraine Headache Days (MHD)||Standard Error|Least Squares Mean
1219034|NCT00741936|Primary|Responder of Complete Spontaneous Bowel Movement (CSBM)|Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|End of treatment (wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1219035|NCT00741936|Secondary|Success of Blinding|The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken.|End of follow-up (Wk18)|Only for subjects attended the last follow-up visit on Wk 18.|||participants|Participants||Number
1219017|NCT00742183|Primary|Compare the Costs of Using the Interventions (Direct and Indirect)|"The incremental cost-effectiveness ratio is calculated as the difference in total costs in each group divided by the difference in rate of full re-epithelialization (taken from the survival curve) at 20 days in each group (Δcosts/ Δeffects). Total costs were calculated based on the costs of primary and secondary dressings, silver sulphadiazine cream and estimated application, labor, supplies and pain medications. These costs were estimated from a representative sample of each population, across study facilities, using activity-based costing methods.~The incremental cost-effectiveness ratio is interpreted as the price of additional health benefits. The ratio is supposed to be used by decision makers, in order for them to compare their willingness-to-pay for an additional health benefit with the pr"|August 2008-August 2009|Primary analysis: the Intention To Treat (ITT) population will include all patients subject to at least one post-randomisation treatment and that provide some data for the primary endpoint. If there are any patients included which do not comply with the inclusion/exclusion criteria they will be included in the ITT population|||dollars||95% Confidence Interval|Mean
1219018|NCT00742170|Secondary|Opioid Craving (Self-report)|Self-report on scale of 3 to 30 (higher number indicates more craving)|at 2-weeks post discharge||||units on a scale||Standard Deviation|Mean
1219019|NCT00742170|Primary|Percent of Participants Using Drugs||2 weeks following discharge||||percent|||Number
1219020|NCT00742079|Secondary|Change in the Maudsley Assessment of Delusions Scale|This scale is a one-question item added on to the Bead Task. The one item asks for a certainty rating, from 1-3. Higher scores represent better outcomes.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1219021|NCT00742079|Secondary|Change in Bead Task Score Measuring Probabilistic Reasoning|The Bead task is a reasoning task, where the number of beads guessed is the numeric value represented in the data. The lower end range is 1, and there is no upper range limit. Higher scores represent better outcomes.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1219022|NCT00742079|Secondary|Change in Beck Cognitive Insight Scale (BCIS)|"The BCIS is a 15-item self-report scale with Likert items 0-3. It consists of a composite score, where higher scores represent better outcomes, and there are 2 subscales: 1) Self-Reflectiveness (higher scores represent better outcomes) and 2) Self-Certainty (higher scores represent worse outcomes). The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty.~Step 1. Score every item on the BCIS from “0” to “3” according to the following rule:~“Do Not Agree at All” = 0, “Agree Slightly” = 1, “Agree a Lot” = 2, “Agree Completely” = 3 Step 2. Calculate self-reflectiveness subscale: sum items 1, 3, 4, 5, 6, 8, 12, 14, and 15.~Step 3. Calculate self-certainty subscale: sum items 2, 7, 9, 10, 11, and 13. Step 4. Calculate BCIS composite index: self-reflectiveness minus self-certainty."|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1219023|NCT00742079|Secondary|Change in Psychotic Rating Scales (PSYRATS) Delusion Score|The Delusions subscale is a 6 item clinician administered scale, with Likert items 0-4 and range is 0-24. Higher scores represent worse outcomes|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1219024|NCT00742079|Primary|Change in Alternative Beliefs Assessment|Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1219025|NCT00742053|Primary|Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction|In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.|during catheter insertion||||cm||Standard Deviation|Mean
1219026|NCT00741988|Secondary|Characterization of the Toxicity in Patients With Previously Untreated Advanced NSCLC Treated With Ixabepilone and Carboplatin With and Without Bevacizumab.||18 months|||||||
1219027|NCT00741988|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||months||95% Confidence Interval|Median
1219028|NCT00741988|Secondary|Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease||18 months||||months||95% Confidence Interval|Median
1219029|NCT00741988|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months||||percentage of participants||95% Confidence Interval|Number
1219030|NCT00741936|Secondary|Serum Glutamic Oxaloacetic Transaminase (SGOT)||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
1219031|NCT00741936|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
1219032|NCT00741936|Secondary|Blood Creatinine Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||μmol/L||Standard Deviation|Mean
1219033|NCT00741936|Secondary|Blood Urea Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||mmol/L||Standard Deviation|Mean
1219089|NCT00741091|Secondary|Target Lesion Revascularization|Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.|30 days||||Participants|||Number
1219036|NCT00741936|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Wk 6, 10 & wk 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1219037|NCT00741936|Secondary|Changes on Individual Symptom Scores|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1219038|NCT00741936|Secondary|Complete Spontaneous Bowel Movement (CSBM)||Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
1219039|NCT00741936|Secondary|Bowel Movement||Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
1219040|NCT00741936|Secondary|Responder of Complete Spontaneous Bowel Movement (CSBM)|"Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.~CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours."|End of follow up (wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1219041|NCT00741858|Primary|Physical Health Quality of Life|Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)|7 years||||units on a scale||Standard Error|Mean
1219042|NCT00741819|Secondary|Drug Administration Activities Questionnaire|Change in tasks from Baseline to Week 12. At Baseline and Week 12, subjects provided information related to the daily administration and time requirements of inhaled iloprost (Baseline) and inhaled treprostinil (Week 12).|Baseline and 12 weeks|Subjects who completed the questionnaire at Baseline and Week 12.|||minutes||Standard Deviation|Mean
1219043|NCT00741819|Secondary|World Health Organization (WHO) Functional Class|Change in WHO Functional Class (FC) from Baseline to Week 12. Data presented as percent of subjects who either improved FC, worsened FC, or had no change in FC from Baseline to Week 12.|Baseline and 12 Weeks|Subjects still enrolled at Week 12 with a WHO Functional Class at Baseline and Week 12.|||percentage of subjects|||Number
1219044|NCT00741819|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)|Change in NTpro-BNP from Baseline to Week 12. Blood samples were collected for plasma NTpro-BNP analysis during the study.|Baseline and Week 12|Subjects with a NTproBNP sample drawn at Baseline and Week 12|||pg/mL||Full Range|Median
1219045|NCT00741819|Secondary|Patient Impression of Change|The patient impression of change (PIC) was three single therapy-related questions related to the subjects overall impression of the transition from inhaled iloprost to inhaled treprostinil. Subjects were surveyed related to their overall impression of the transition from inhaled iloprost to inhaled treprostinil at Week 12.|Baseline and 12 weeks|Subjects who completed questionnaire at Baseline and Week 12|||percentage of patients|||Number
1219046|NCT00741819|Secondary|Treatment Satisfaction Questionnaire of Medication (TSQM)|Change in TSQM score from Baseline to Week 12. The TSQM is a validated instrument (Health and Quality of Life Outcomes 2004, 2:12) that measures major dimensions of patient satisfaction with medications. The questionnaire is comprised of 15 questions which fall into one of four categories; Effectiveness, Side-Effects, Convenience, and Global Satisfaction. Responses are scaled on a seven point bipolar scale from 'Extremely Satisfied' to 'Extremely Dissatisfied' where higher scores indicate improvements (total scores from 0-100). The questionnaire was completed at Baseline and Week 12. The Baseline questionnaire focused on the subject’s satisfaction with inhaled iloprost treatment, while the questionnaire completed at Week 12 focused on the subject’s satisfaction with inhaled treprostinil.|Baseline and 12 weeks|Subjects who completed the TSQM at Baseline and Week 12. Total analysis population was less for the Convenience Score (N=67) and Global Satisfaction Score (N=66).|||units on a scale||Full Range|Mean
1219047|NCT00741819|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 12. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 12 weeks|Subjects who were still enrolled and completed the questionnaire at Baseline and Week 12. Total analysis population was less for the activity score and total score (N = 67).|||units on a scale||Full Range|Mean
1219048|NCT00741819|Secondary|Six-minute Walk Distance (6MWD)|Change in 6MWD from Baseline to Week 12. The 6-minute walk test (6MWT) was conducted at Baseline (10–30 minutes following the last dose of inhaled iloprost) and at Week 12 (10–60 minutes following the dose of inhaled treprostinil). The change in distance (meters) between Baseline and Week 12 is reported below.|Baseline and 12 weeks|Subjects enrolled at Week 12 visit.|||meters||Full Range|Median
1219049|NCT00741819|Primary|Number of Adverse Events|Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.|up to 24 months|All subjects who received at least one dose of inhaled treprostinil were included in the safety analysis population.|||number of events|||Number
1223627|NCT00711009|Secondary|Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1219051|NCT00741611|Secondary|Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.|Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.|12 months|All mesh treated patients.|||participants|||Number
1219052|NCT00741611|Primary|Number of Participants With Freedom From Symptomatic Atrial Fibrillation|Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.|12 months|All treated patients||||||
1219053|NCT00741611|Primary|Number of Participants With Serious Atrial Fibrillation Events|Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.|12 months|All treated patients.|||participants|||Number
1219054|NCT00741611|Primary|Number of Participants With Major Complications|A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.|12 months|Patients who were treated with the HD Mesh Ablation System|||participants|||Number
1219055|NCT00741598|Secondary|Quality of Life Satisfaction Questionnaire (Q-LES-Q)|"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction.~The outcome measures presented are Q-LES-Q Total score = Sum of all scores from all 16 areas of functioning"|Screening||||units on a scale||Standard Deviation|Mean
1219056|NCT00741598|Secondary|The Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT is a brief measure of functional impairment. The total scale score is a sum of four items with range of scale from 0 to 26 (from no impairment to severe impairment).|Baseline, Weeks 4, 8, 12, and 16||||units on a scale||Standard Deviation|Mean
1219057|NCT00741598|Primary|The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16|"Conner’s CPT (Conner’s Continuous Performance Task) is a neuropsychological test that measures a person's sustained and selective attention. Subjects are instructed to click the space bar when they are presented with any letter except the letter X. The person must refrain from clicking if they see the letter X presented. Clicking to the letter “X” is a commission error, not clicking to other letters are omission errors.~The outcome measures presented are Total number of errors = Total number of omission + commission errors This outcome measure is presented at each study visit (baseline, week 4, week 8, week 12, and week 16)"|Measured at screening; baseline; and Weeks 4, 8, 12, and 16||||total number of errors||Standard Deviation|Mean
1219058|NCT00741598|Primary|Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16|"WCST (Wisconsin Card Sorting Test) is a neuropsychological test measuring the ability to display flexibility in the face of changing schedules of reinforcement. Subjects are presented with cards and requested to match them. Unbeknownst to the subject, the matching rules change while the test is delivered. The test measures subjects' ability to understand the new rules.~The outcome measures presented are Total correct baseline = total correct card choices at baseline Total errors baseline = total erroneous card choices at baseline Total correct week 16 = total correct card choices at week 16 Total errors baseline = total erroneous card choices at week 16"|Measured at screening and Week 16||||number of card choices made||Standard Deviation|Mean
1219059|NCT00741598|Primary|Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16|"CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are:~CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16."|Measured at screening and Week 16||||number of total words remembered||Standard Deviation|Mean
1219060|NCT00741468|Primary|Plasma AUC Ratio of Day 1 and Day 8|"Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). The Day 8 AUC was compared to the Day 1 AUC to determine inhibition.~For CYP1A2 the plasma paraxanthine/caffeine MR ratio (metabolic ratio) was used. For CYP2D6 the MR ratio of dextromethorphan/dextrorphan was used."|8 days|One subject had concentrations of Proellex (CDB-4124 and CDB-4453) that were below the lower level of quantitation at all time points tested and was excluded from the pharmacokinetic analyses.|||Ratio of geometric means Day 8 to Day 1||90% Confidence Interval|Mean
1219061|NCT00741390|Secondary|Reported Device Preference Within Lancing Pair at Visit 2|"After each pair of 4 lancings, the subject was asked: Which of the two devices did you find more comfortable, overall? The choices were: first lancing, second lancing or equivalent. The Stated Preference row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The No Preference row includes lancing pairs with preference of equivalent or no answer."|Approximately Day 3 (Visit 2)|Comfort was analyzed per lancing pairs. 236 subjects performed up to 4 lancing pairs. 869 pairs were evaluated across the 4 arms. Pairs were excluded if they did not result in a valid meter reading or associated with protocol deviations or had missing comfort data.|||lancing pairs|||Number
1219062|NCT00741390|Secondary|Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)|"The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs.~After each pair of lancing, the subject was asked to record the difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second."|Approximately Day 3 (Visit 2)|61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above.|||mm||Standard Deviation|Mean
1219063|NCT00741390|Primary|Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)|In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.|Approximately Day 3 (Visit 2)|Of the 234 subjects that completed Visit 2, 229 had evaluable pairs and were included in the analysis for Visit 2. Some of the lancing pairs from several subjects were excluded due to protocol deviations, subject discontinuation or adverse events. Of these 175 subjects were analyzed for this primary outcome.|||mm||Standard Deviation|Mean
1219064|NCT00741390|Primary|Blood Sample of Sufficient Volume to Yield a Valid Meter Reading|Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.|Study Day 1 (Visit 1)|BD/BD33g and Mini/BD33g were included in 4 arms,the Mini/OT28g in 2 arms,and Ultra/OT28g and AC/AC28g in 1 arm. Thus the # of subj evaluated for each device was 246, 246, 124, 63, and 60, resp. Subj were analyzed for blood volume adequacy if they completed the depth setting/volume testing for at least 1 device w/o significant protocol deviation.|||Participants|||Number
1219065|NCT00741338|Secondary|Percent Reduction of Urinary Glycosaminoglycan (uGAG) Level From Baseline to the End of Treatment/Early Withdrawal|Urinary Glycosaminoglycan (uGAG) Levels: concentration of glycosaminoglycan (GAG) relative to creatinine in urine. A greater decrease in uGAG level indicates a greater response.|Baseline, end of treatment/early withdrawal (up to 24 weeks after start of full-dose laronidase therapy)|Safety population included all participants who received any study drug treatment.|||percent change in uGAG level||Full Range|Median
1219066|NCT00741338|Primary|Number of Participants Who Achieved Immune Tolerance Induction|Immune tolerance induction success was defined as development of an anti-laronidase immunoglobulin G (IgG) antibody titer less than or equal to (<=) 1:3200 after 24 weeks of receiving full-dose (0.58 mg/kg) laronidase therapy.|24 weeks after start of full-dose laronidase therapy|Safety population included all participants who received any study drug treatment.|||participants|||Number
1219067|NCT00741286|Secondary|Number of Patients With First Recurrent Stroke of Any Type||90 days||||participants|||Number
1219068|NCT00741286|Primary|The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study|The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling’s PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study.|14 days and 90 days from the baseline TCD study|Of the 203 patients included in the intention-to-treat analysis, 164 were included in the per-protocol analysis of the primary outcome.|||ratio||Standard Deviation|Mean
1219069|NCT00741273|Primary|Proellex Half-life (T1/2)|Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours||||Hours||Standard Deviation|Mean
1219070|NCT00741273|Secondary|Area Under the Curve (AUC0-t) for Proellex|AUC0-t of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose.|48 hours||||ng x min/L||Standard Deviation|Mean
1219071|NCT00741273|Primary|Maximum Blood Concentration (Cmax)|Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours||||ng/L||Standard Deviation|Mean
1219072|NCT00741260|Primary|Maximum Tolerated Dose (MTD) of Capecitabine|MTD reflects the highest dose of capecitabine in combination with neratinib that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.|From first dose date to day 21.|All patients in the safety population in part 1 (dose-escalation) of the study.|||mg/m^2|||Number
1219073|NCT00741260|Primary|Maximum Tolerated Dose (MTD) of Neratinib|MTD reflects the highest dose of neratinib plus capeciteabine that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.|From first dose date to day 21.|All patients in the safety population in part 1 (dose-escalation) of the study.|||mg|||Number
1219139|NCT00740714|Secondary|Adverse Experiences: Constipation: Moderate/Severe|Number of participants with moderate/severe constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1219074|NCT00741260|Secondary|Duration of Response|Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|From start date of response to first PD/death, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||weeks||95% Confidence Interval|Median
1219075|NCT00741260|Secondary|Clinical Benefit Rate|The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From first dose date to progression or last tumor assessment, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||percentage of participants||95% Confidence Interval|Number
1219076|NCT00741260|Secondary|Overall Response Rate|Number of Subjects with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||percentage of participants||95% Confidence Interval|Number
1219077|NCT00741260|Primary|Number of Participants With Dose Limiting Toxicities|Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).|From first dose date to day 21|Safety population|||Participants|||Count of Participants
1219078|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat|Systemic, pulmonary and cerebral resistance is compared at baseline and after enalaprilat|Baseline and after enalaprilat||||Wood units per metre squared||Full Range|Median
1219079|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat||Baseline and after enalaprilat||||l/min/m2||Inter-Quartile Range|Median
1219080|NCT00741104|Primary|Number of Patients Agreeing to Participate in a Dose Reduction Study|"As part of the Remicade questionnaire, patients were asked would you consider participating in a dose reduction study?"|Measured from the Remicade Questionnaire at first (and only) study visit|Out of the 363 subjects in the analysis, 361 subjects answered this question.|||participants|||Number
1219081|NCT00741104|Primary|Patient Response to Increased Dosing Interval|"Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked did you notice any difference when your dosing interval was extended? Those who noticed a difference were asked if their experience was positive or negative."|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks. Among the 106 patients who increased dosing interval, 79 noticed a difference. These 79 were analyzed for this measure.|||participants|||Number
1219082|NCT00741104|Primary|Reason for Extending Dosing Interval|Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks.|||participants|||Number
1219083|NCT00741104|Secondary|Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
1219084|NCT00741104|Secondary|Adverse Events (AEs)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
1219085|NCT00741104|Secondary|Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
1219086|NCT00741104|Primary|Dosing Interval Between the Infliximab Infusions|Patients were asked as part of the Remicade questionnaire what dosing interval they were on.|Measured from the Remicade Questionnaire at first (and only) study visit||||participants|||Number
1219087|NCT00741091|Secondary|Device Malfunction|Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.|30 days||||Devices|||Number
1219088|NCT00741091|Secondary|System Technical Success|System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.|30 days|To be evaluable for system technical success, subjects needed to have a Carotid WALLSTENT deployment attempted.|||Participants|||Number
1219090|NCT00741091|Secondary|Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)|Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.|30 days||||Participants|||Number
1219091|NCT00741091|Primary|Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)|Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).|30 days|All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.|||Participants|||Number
1219092|NCT00741039|Primary|Determine Response Rate of Patients > or = to 65 Yrs Diagnosed|For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).|8-16 weeks following vaccination.||||participants|||Number
1219093|NCT00741026|Secondary|Diastolic Blood Pressure|Diastolic Blood Pressure|3 Days||||mmHg||Standard Error|Mean
1219094|NCT00741026|Secondary|Systolic Blood Pressure|Systolic Blood Pressure|3 Days||||mmHg||Standard Error|Mean
1219095|NCT00741026|Secondary|Heart Rate|Heart Rate|3 Days||||beats per minute||Standard Error|Mean
1219096|NCT00741026|Secondary|BMI|BMI|3 Days||||kg / m2||Standard Error|Mean
1219097|NCT00741026|Secondary|Body Weight|Body Weight|3 Days||||kg||Standard Error|Mean
1219098|NCT00741026|Secondary|Total Cholesterol|Total Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
1219099|NCT00741026|Secondary|LDL Cholesterol|LDL Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
1219100|NCT00741026|Secondary|Triglycerides|Triglycerides|3 Days||||mg/dl||Standard Deviation|Mean
1219101|NCT00741026|Secondary|HDL Cholesterol|HDL Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
1219102|NCT00741026|Primary|Plasma Free Fatty Acid|Plasma Free Fatty Acid|3 Days||||mM||Standard Deviation|Mean
1219103|NCT00741026|Primary|Oral Glucose Tolerance|Oral Glucose Tolerance|3 Days||||min*mg/dl||Standard Deviation|Mean
1219104|NCT00741026|Primary|Plasma Leptin|Leptin following placebo or olanzapine treatment|3 Days||||ng/ml||Standard Deviation|Mean
1219105|NCT00741013|Secondary|Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation|Number of total nucleated cells isolated from the first aliquoe of BAL obtained to correlate with PET data.|24 hours after endotoxin instillation||||cells per cubic mm||Standard Deviation|Mean
1219106|NCT00741013|Primary|Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation|Calculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment|24 hours after endotoxin instillation||||Change in Ki||Standard Deviation|Mean
1219107|NCT00740870|Secondary|Functional Assessment (NYHA Classification)|Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.|6 Months|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours and had paired data from pre-implant to 6 months post-implant.|||Participants|||Count of Participants
1219108|NCT00740870|Secondary|Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)|Deaths (all-cause, procedural and device-related) at 5 years|5 years|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.|||percentage of subjects||95% Confidence Interval|Number
1219109|NCT00740870|Secondary|Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit|Freedom From Surgical Replacement of the RVOT Conduit|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
1219110|NCT00740870|Secondary|Kaplan-Meier Freedom From Catheter Re-intervention on TPV|All Catheter Re-intervention on TPV at 5 years|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
1219111|NCT00740870|Secondary|Kaplan-Meier Freedom From Major Stent Fracture at 5 Years|Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
1219112|NCT00740870|Secondary|Serious Device-related Adverse Event|A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).|5 years|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.|||percentage of subjects|||Number
1219113|NCT00740870|Secondary|Serious Procedural Adverse Event (AE)|A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).|5 years|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.|||percentage of subjects|||Number
1219114|NCT00740870|Secondary|Procedural Success|"Procedural success is a composite outcome defined as:~Melody TPV fixated within the desired location~Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant~Less than mild pulmonary regurgitation by angiography post-implant~Free of explant at 24 hours post-implant"|Within 24 Hours post implant|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).|||percentage of subjects|||Number
1219115|NCT00740870|Primary|Kaplan-Meier Freedom From TPV Dysfunction|"To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following:~Hemodynamic dysfunction of the TPV~Moderate or greater pulmonary regurgitation, and/or~Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg~RVOT reoperation for conduit dysfunction or device-related reasons~Catheter re-intervention on the TPV"|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
1219116|NCT00740857|Secondary|Time to First Perceptible Relief|The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.|||minutes||95% Confidence Interval|Median
1219117|NCT00740857|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours|TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1219118|NCT00740857|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours|SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1219119|NCT00740857|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points|PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1219120|NCT00740857|Secondary|Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours|SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1219121|NCT00740857|Secondary|Pain Relief (PR) Scores at Individual Time Points|"Response to the question How much pain do you have from your starting pain? was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken."|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1219122|NCT00740857|Secondary|Pain Intensity Difference (PID) Scores at Each Individual Time Points|PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1219123|NCT00740857|Primary|Time to Meaningful Pain Relief|Subjects evaluated the time to “First Perceptible” Relief by depressing a stopwatch at the moment they first began to experience “perceptible” relief and the time to “Meaningful” Relief by depressing a second stopwatch at the moment they first began to experience “meaningful” relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.|||minutes||95% Confidence Interval|Median
1219124|NCT00740831|Primary|Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist|"Difference in percentage of subjects reporting moderate or severe hot flushes:~Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17."|Up to week 17|Safety population|||percentage of patients|||Number
1219125|NCT00740831|Primary|Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist|Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples|Week 13 visit|Safety population|||log 10 (log pg/ml) E2||Standard Error|Mean
1219140|NCT00740714|Secondary|Adverse Experiences: Depression|Number of participants with depression|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1219126|NCT00740831|Secondary|Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13|"Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.~The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10)."|3 months|Per protocol|||Log 10 (Log cm3) Total volume||Standard Error|Mean
1219127|NCT00740831|Primary|Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment."|3 months|Per protocol|||percentage of patients|||Number
1219128|NCT00740792|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population (18 yrs of age and older) who have had one post baseline efficacy observation|||units on a scale||Standard Deviation|Least Squares Mean
1219129|NCT00740792|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative value is suggestive of improvement."|day 1 to14|Intent to Treat (ITT)population includes all subjects who were randomized and had at least one post baseline efficacy observation.|||units on a scale||Standard Deviation|Least Squares Mean
1219130|NCT00740792|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how you felt over the previous 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improvement."|day1 to 14 days|Intent-to-Treat(ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation|||units on a scale||Standard Deviation|Least Squares Mean
1219131|NCT00740779|Primary|National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.|Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||Units on a 0 to 43 scale||Standard Deviation|Mean
1219132|NCT00740727|Secondary|Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up|"Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.~Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back)."|2 days|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
1219133|NCT00740727|Secondary|Number of Participants With Pain During EASI Infusion|Assessment during EASI placement & initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
1219134|NCT00740727|Primary|Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose|Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
1219135|NCT00740727|Primary|Number of Participants With Successfully Placed EASI Lines|"Ability of Basic Life Support (BLS) providers to place EASI access lines.~The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed)."|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
1219136|NCT00740714|Secondary|Adverse Experiences: Insomnia: Moderate/Severe|Number of participants with moderate/severe insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1219137|NCT00740714|Secondary|Adverse Experiences: Back Pain: Moderate/Severe|Number of participants with moderate/severe back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1219138|NCT00740714|Secondary|Adverse Experiences: Anxiety: Moderate/Severe|Number of participants with moderate/severe anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1219153|NCT00740714|Secondary|Change in Hoehn & Yahr Score From Baseline to 16 Months|The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1219154|NCT00740714|Secondary|Change in Symbol Digit Modalities Test From Baseline to 16 Months|The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1219155|NCT00740714|Secondary|Change in PD Quality of Life Scale From Baseline to 16 Months|The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1219156|NCT00740714|Secondary|Change in Modified Rankin Scale From Baseline to 16 Months|The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1219157|NCT00740714|Secondary|Change in Modified Schwab & England Independence Scale From Baseline to 16 Months|This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1219158|NCT00740714|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|Eligible research participants were assigned by randomization to one of three treatment groups: CoQ10 2400 mg/day, CoQ10 1200 mg/day or matching placebo. All participants also received 1200 IU of vitamin E daily.|||units on a scale||Standard Error|Least Squares Mean
1219159|NCT00740636|Primary|The Objective Overall Response|"The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years||||participants|||Number
1219160|NCT00740597|Primary|Wound Complication Rate|"Major wound complications up to 4 months post surgery include:~Complications requiring a secondary operation under general or regional anesthesia for wound care.~Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days."|1 year|The one patient accrued to the study stopped treatment prior to completing treatment due to insurance denial.||||||
1219161|NCT00740584|Secondary|Number of Participants With Adverse Experiences|Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product|Approximately 13 weeks|All Enrolled|||Participants|||Count of Participants
1219162|NCT00740584|Primary|HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)|"The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture.~The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has."|at 3 hours||||percent anti-viral activity||Inter-Quartile Range|Median
1219163|NCT00740480|Secondary|Tissue Reaction to Implant|None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.|One week post surgery|ITT|||participants|||Number
1219166|NCT00740207|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose||||Participants|||Number
1219167|NCT00740207|Secondary|The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable.|Immediately postdose|Patients who did not deviate from the planned protocol.|||Participants|||Number
1219168|NCT00740207|Primary|Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.|Immediately prior to power injection run and again immediately following power injection run|Patients who did not deviate from the planned protocol.|||Participants|||Number
1219169|NCT00740181|Primary|Response Rate|"Complete Response/Complete Remission:~Complete remission (CR) is defined as the presence of all of the following:~Peripheral blood - No leukemic blasts present.~No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)~Bone marrow~No Auer rods~Less than 5% blast cells.~CBC and bone marrow criteria must be met within one week of each other.~Hemoglobin 9g/dl or greater~Neutrophil count >1000 and platelet count >100,000.~RBC Transfusion free for 2 weeks."|within 30 days of last treatment||||participants|||Number
1219170|NCT00740051|Secondary|The Change in FPG From Baseline by Visit Over Time|This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.|Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)|||mg/dL||Standard Deviation|Mean
1219171|NCT00740051|Secondary|The Change in HbA1c From Baseline by Visit Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.|Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)|||percent||Standard Deviation|Mean
1219172|NCT00740051|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders.|||percent of patients|||Number
1219173|NCT00740051|Secondary|Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|FAS patients with baseline HbA1c >= 6.5%. Patients without a value at Week 18 were analysed as non-responders.|||percent of patients|||Number
1219174|NCT00740051|Secondary|Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|Full Analysis Set (FAS) patients with baseline HbA1c >= 7.0%. Patients without a value at week 18 were analysed as non-responders.|||percent of patients|||Number
1219175|NCT00740051|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).|Baseline and week 18|All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis).|||mg/dl||Standard Error|Mean
1219176|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Final Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Mean
1219177|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Interim Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Mean
1219178|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)|Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromatography tandem mass spectrometric method. Vc/F value based on 70 kg body weight. Parameter estimation uncertainty (95% CI) by non-parametric bootstrap analysis. Data presented are result of model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.|||liters||95% Confidence Interval|Number
1240131|NCT00581048|Secondary|Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL||baseline to after 16-18 weeks of treatment with vitamin E daily||||pg/mL||Inter-Quartile Range|Median
1219179|NCT00739999|Secondary|Percent Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial Flow-Mediated Dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.|||percent change in FMD||Standard Deviation|Mean
1219180|NCT00739999|Secondary|Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial artery flow-mediated dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. Standardized image acquisition: brachial artery images recorded for one minute at rest, blood pressure cuff inflated to 250 mm Hg for 5 minutes with brachial artery imaged continuously throughout cuff inflation, cuff released to produce reactive hyperaemia and the brachial artery imaged continuously for 3 minutes after release. Total duration of measurement approximately 25 minutes. Change from baseline = value at observation minus baseline value.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.|||FMD||Standard Deviation|Mean
1219181|NCT00739999|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Very low-density lipoprotein-cholesterol (VLDL-C): percent (%) change from baseline by treatment over time = [VLDL-C at observation minus VLDL-C at Week 0] divided by VLDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in VLDL-C||Standard Deviation|Mean
1219182|NCT00739999|Secondary|Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) measured in millimoles per liter (mmol/L). Change from baseline = value at observation minus baseline value. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
1219183|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apolipoprotein B (Apo B): percent (%) change from baseline by treatment over time = [Apo B at observation minus Apo B at Week 0] divided by Apo B at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in Apo B||Standard Deviation|Mean
1219184|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein B (Apo B)|Change from baseline in Apolipoprotein B measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||g/L||Standard Deviation|Mean
1219185|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Apolipoprotein A-1 (Apo A-1): percent (%) change from baseline by treatment over time = [Apo A-1 at observation minus Apo A-1 at Week 0] divided by Apo A-1 at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in Apo A-1||Standard Deviation|Mean
1219186|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Change from baseline in Apolipoprotein A-1 measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||g/L||Standard Deviation|Mean
1219187|NCT00739999|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|High-density lipoprotein cholesterol (HDL-C): percent (%) change by treatment over time = [HDL-C at observation minus HDL-C at Week 0] divided by HDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in HDL-C||Standard Deviation|Mean
1219188|NCT00739999|Secondary|Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|Change from baseline in high-density lipoprotein cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
1219189|NCT00739999|Secondary|Percent Change From Baseline in Triglycerides (TG)|Triglycerides (TG): percent (%) change from baseline by treatment over time = [TG at observation minus TG at Week 0] divided by TG at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in TG||Standard Deviation|Mean
1219190|NCT00739999|Secondary|Absolute Change From Baseline in Triglycerides (TG)|Change from baseline in triglycerides measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
1219191|NCT00739999|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Total cholesterol (TC): percent (%) change from baseline by treatment over time = [TC at observation minus TC at Week 0] divided by TC at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in TC||Standard Deviation|Mean
1219192|NCT00739999|Secondary|Absolute Change From Baseline in Total Cholesterol (TC)|Total Cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
1219193|NCT00739999|Secondary|Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density Lipoprotein Cholesterol (LDL-C): percent (%) change from baseline by treatment over time = [LDL-C at observation minus LDL-C at Week 0] divided by LDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in LDL-C||Standard Deviation|Mean
1220415|NCT00732940|Secondary|Median Percent Change From Baseline in Compliment C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1219194|NCT00739999|Secondary|Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density lipoprotein cholesterol (LDL-C) measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|Pharmacodynamic (PD) analysis population: all enrolled subjects who received ≥ 1 dose of study drug and had ≥ 1 PD parameter measurement.|||mmol/L||Standard Deviation|Mean
1219195|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)|Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensitive, and specific high-performance liquid chromatography tandem mass spectrometric method. Data presented are the result of the model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.|||L/hr|||Number
1219196|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Systolic Blood Pressure Response|Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure < 140 mmHg or a >= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
1219197|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response|Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure < 90 mmHg or a >=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
1219198|NCT00739973|Secondary|Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study|Blood pressure control defined as msSBP < 140 mm Hg and msDBP < 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
1219199|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219200|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219201|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219202|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219203|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219204|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219205|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219206|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All randomized patients who received the study medication.|||mm Hg||Standard Error|Least Squares Mean
1219207|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219208|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219224|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1220416|NCT00732940|Secondary|Absolute Change From Baseline in Complement C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.|||mg/L||Standard Error|Mean
1219209|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219210|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219211|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219212|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219213|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219214|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219215|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219318|NCT00738881|Secondary|Time to Treatment Failure|The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves.|The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
1219216|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219217|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219218|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219219|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219220|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219221|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219222|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1219223|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1219225|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1219226|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N=number of participants with analyzable data.|||hours||Full Range|Median
1219227|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1219228|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1219229|NCT00739934|Secondary|Trough Concentrations (Cmin)||Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.|||μg/mL||Standard Deviation|Geometric Mean
1219230|NCT00739934|Secondary|Tmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1219231|NCT00739934|Secondary|Cmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1219232|NCT00739934|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1219233|NCT00739934|Primary|Tmax Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1219234|NCT00739934|Primary|Cmax,ss Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1219235|NCT00739934|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1219236|NCT00739934|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1219237|NCT00739934|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1219238|NCT00739934|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|Intent-to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1219239|NCT00739908|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|CGI-S measures the study rater's assessment of the severity of depression illness. CGI-S is rated on a scale of 1-7 as follows: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill patients. CGI-S was measured at randomization and Weeks 1, 2, 4 and 6. Percentage of subjects reported as normal, not at all ill; borderline mentally ill; and mildly ill is reported here at Week 6 or the last available post treatment result (LOCF).|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants|||Number
1219251|NCT00739882|Primary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA – H&F) Rating Of Clear, Almost Clear Or Mild At Week 12|"The proportion of subjects achieving a PGA – H&F rating of clear, almost clear, or mild at Week 12:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1219240|NCT00739908|Secondary|Clinical Global Impression - Improvement of Illness (CGI-I)|"The Clinical Global Impression - Improvement of Illness (CGI-I) was rated on a 7-point scale by the investigator to measure subject’s total improvement compared to his/her condition at randomization according to the following scale: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I was measured at Weeks 1, 2, 4 and 6. Percentage of participants very much improved and much improved at Week 6 or the last available post treatment result (LOCF) is reported here."|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants|||Number
1219241|NCT00739908|Secondary|Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)|IDSR-SR 30 measures the severity of depressive symptoms by subjects. This scale has 30 items. The minimum score is 0 and the maximum possible IDS-30 score is 90 (the highest severity). IDS-SR30 was administered at screening, randomization and Weeks 1, 2, 4, and 6. Change from randomization in the IDS-SR30 total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||units on a scale||95% Confidence Interval|Least Squares Mean
1219242|NCT00739908|Secondary|The Hospital Anxiety and Depression Scale (HADS)|HADS is a subject-rated questionnaire designed to detect states of anxiety and depression. The HADS consists of 14 questions relating to anxiety or depression, each with a choice of four responses [Zigmond, 1983]. These responses are numerically scored 0-3, with 0 representing the least severe response and 3 representing the most severe response. The highest possible total score is 42. HADS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. Change from randomization in the HADS total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||units on a scale||95% Confidence Interval|Least Squares Mean
1219243|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate|Percentage of participants with total MADRS score of 11 or less. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Remitter rate at Week 6 or the last available post treatment result (LOCF)is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants||95% Confidence Interval|Number
1219244|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate|MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. Percentage of participants who achieved a reduction in total MADRS score of at least 50% or more as compared to baseline. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Responder rate at Week 6 or the last available post treatment result (LOCF) is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomization MADRS score.|||percentage of participants||95% Confidence Interval|Number
1219245|NCT00739908|Primary|Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.|Randomization and study end (Week 6).|mITT population consisted of all patients with at least one post randomzation MADRS score. The primary efficacy variable was the change-from-randomization to each available post-randomization measurement of the MADRS total score, used as the response variable in a mixed model repeated measures (MMRM) analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1219246|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.~Cleared = 100% improvement; Excellent = 75-99% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1219247|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12.~Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1219248|NCT00739882|Secondary|Proportion of Participants From the Initial Placebo Group Achieving a PGA – H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24.|"The proportion of participants achieving a PGA – H&F rating of clear, or almost clear, at Week 24:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1219249|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24|"The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1219250|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12|"The proportion of participants achieving a PGA – H&F rating of clear, or almost clear, at Week 12:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1219281|NCT00739336|Secondary|Questionnaires||baseline, 3, 6, 12 months|||||||
1219252|NCT00739765|Secondary|Hamilton Depression Rating Scale|Continuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores <8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62|After 14 weeks of treatment||||units on a scale||Standard Deviation|Mean
1219253|NCT00739765|Primary|Clinician-Administered PTSD Scale (CAPS)|Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores >50 indicate at least moderately severe PTSD; scores <20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75–90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156|After 14 weeks of treatment||||units on a scale||Standard Deviation|Mean
1219254|NCT00739752|Primary|Mean Number of Doses of HBV Vaccine Received|Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses.|Day of research visit with 8 month follow-up||||Doses of HBV Vaccine||Standard Deviation|Mean
1219255|NCT00739674|Secondary|Time to Achieve the Target Blood Pressure From Baseline|Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 437 and 386 patients for L group and DML group respectively.|||Weeks||95% Confidence Interval|Median
1219256|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1219257|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1219258|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1219259|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1219260|NCT00739674|Primary|Change in Diastolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1219261|NCT00739674|Primary|Change in Systolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1219262|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment|40 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 351 and 331 patients at week 40 for L group and DML group respectively.|||Participants|||Number
1219263|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment|10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||Participants|||Number
1219264|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment|6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||Participants|||Number
1219265|NCT00739674|Primary|Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||Participants|||Number
1219266|NCT00739661|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death by any cause.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.|||Months||Standard Deviation|Mean
1219267|NCT00739661|Secondary|Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression|Hedgehog antigen expression was measured with immunohistochemical methods in tumor tissue taken from each patient prior to enrollment in the study. The percentage of cells with (> 0%) and without (0%) Hedgehog antigen expression was measured microscopically. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 29 patients in the vismodegib group and 28 patients in the placebo group.|||Months||95% Confidence Interval|Median
1219268|NCT00739661|Primary|Progression-free Survival (PFS)|PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.|||Months||95% Confidence Interval|Median
1219269|NCT00739648|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|The percent change in the amount of air a patient can exhale in 1 second|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT|||Percent||Standard Error|Least Squares Mean
1219270|NCT00739648|Secondary|Percent Change in Forced Vital Capacity (FVC)|The percent change in the amount of air a patient can inhale|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT|||Percent||Standard Error|Least Squares Mean
1219271|NCT00739648|Secondary|Duration of Acute Exacerbation|From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation|from randomization to the patient's final study visit (up to 12 months)|MITT|||Days||Standard Deviation|Mean
1219272|NCT00739648|Primary|Exacerbation Rate|The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.|From randomization to the patients final study visit (up to 12 months)|modified intent to treat (MITT; patients who received at least one dose of study drug)|||exacerbation per patient year||Standard Error|Mean
1219273|NCT00739596|Secondary|Percentage of Participants Achieving BP Control After 8 Weeks of Treatment|To compare the percentage of patients achieving BP control (<140/90 mm Hg) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.|||Cumulative percentage of participants|||Number
1219274|NCT00739596|Secondary|Percentage of Responders After 8 Weeks of Treatment.|To compare the percentage of responders after 8 weeks of treatment with an aliskiren HCTZ based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension: [ Responders were defined as patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg at 1st response. A response was counted when a patient first achieved MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg.]|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.|||Cumulative percentage of responders|||Number
1219275|NCT00739596|Secondary|Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment|To compare the change from baseline in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
1219276|NCT00739596|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment|To assess the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
1219277|NCT00739596|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment|To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
1219278|NCT00739583|Secondary|Judgment of Reviewing Orthopaedic Surgeons That the Site Marking is Identifiable for Them to Perform Site Identification|The number of sets of initials judged by the viewing orthopedic surgeons as sufficient for adequate site identification. Each participant was labeled with three initials to simulate a surgeon's initials. Ten orthopaedic surgeons determined if the initials were visible enough to allow for site identification. Each surgeon viewed all of the sets of initials, resulting in 100 viewed sets of initials in each group.|at time of surgery, approximately ten minutes||||sets of intials|Participants||Number
1219279|NCT00739583|Secondary|The Mean Change in Gray Level (Contrast) of the Horizontal Line|The Mean change in gray level of the ink line as expressed in units between pre and post skin preparation. Gray level is a unitless value from 0-255 describing the brightness of a pixel (0 being black and 255 being white).|at time of surgery, approximately ten minutes||||gray level units|Participants|Standard Deviation|Mean
1219280|NCT00739583|Primary|Identification of the Random Initials by the Reviewing Orthopaedic Surgeons|The number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.|at time of surgery, approximately 10 minutes||||number of correctly identified initals|Participants||Number
1219288|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.|0 (baseline) and 24 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
1219289|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.|0 (baseline) and 8 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
1219290|NCT00739297|Secondary|Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration|FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (albuterol or matching placebo) 4 hours after treatment with montelukast at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
1219291|NCT00739297|Primary|Change From Baseline in FEV1 Over 4 Hours|FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|0 (=baseline) to 4 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L (Liter)||95% Confidence Interval|Least Squares Mean
1219292|NCT00739102|Secondary|Major Adverse Events at 12-month Post Procedure|Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1219293|NCT00739102|Secondary|Rutherford / Becker Classification Category at 12-month Follow Up||12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1219294|NCT00739102|Secondary|Rutherford/Becker Classification at 30-day Follow Up|"The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:~Stage 0 – Asymptomatic, no hemodynamically significant occlusive disease~Stage 1 – Mild claudication~Stage 2 – Moderate claudication~Stage 3 – Severe claudication~Stage 4 – Ischemic rest pain~Stage 5 – Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia~Stage 6 – Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
1219295|NCT00739102|Secondary|Index Limb Ischemia at 12-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1219296|NCT00739102|Primary|Primary Safety Endpoint|Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30 days post procedure|||participants|||Number
1219297|NCT00739102|Secondary|Index Limb Ischemia at 6-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|6 months|Active subjects in the Modified ITT population at 6-month post procedure|||participants|||Number
1219298|NCT00739102|Secondary|Stent Fracture at 12-month Follow Up|Stent fracture was assessed by x-ray evaluation.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1219299|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1219300|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
1219304|NCT00739102|Primary|12-month Primary Patency Rate|Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound.|12 months|As a subset of the modified ITT, this analysis population consisted of the subjects who had ultrasound assessment at 12 months or had target vessel revascularization (TVR) performed by 12 months.|||participants|||Number
1219305|NCT00739063|Primary|Time to Progression (TTP)|Time to progression calculated from the date of study entry to the date of disease progression or death. Progression of disease is defined by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, as measurable increase in the smallest dimension of any target or not-target lesion, or the appearance of new lesions, since baseline. Confirmed response based on two tumor assessments (imaging) separated by at least 4 weeks.|Baseline to disease progression, up to 22 months with follow up.|Study terminated early, unable to complete overall analysis due to insufficient data.|||months|||Number
1219306|NCT00739050|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
1219307|NCT00739050|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
1219308|NCT00739050|Secondary|Change in Total Cholesterol From Baseline at Week 12|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
1219309|NCT00739050|Primary|Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
1219310|NCT00739024|Primary|T-Test|It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.|4 weeks|||||||
1219311|NCT00738972|Primary|Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients|Left ventricular hypertrophy reduction was to be measured by echocardiography.|6 Month(s)|This study was terminated early and due to sample size it was not possible to perform further statistical analyses.||||||
1219312|NCT00738894|Secondary|Number of Subjects With Effective Closure in Test (Device) Arm|"Assessment of PFO closure in test (device) arm subjects by transesophageal echocardiography (TEE) at 24-month follow-up.~Effective closure defined as occluded, small, or moderate shunt (0-25 bubbles)."|24 months|All subjects randomized to test (device) arm with 24-month PFO closure assessment|||Participants|||Count of Participants
1219313|NCT00738894|Secondary|Number of Subjects With Study-related Serious Adverse Events|Adverse event seriousness and relationship to study treatments (device, procedure, or antiplatelet medical therapy) as reported by each investigative site|24 months|Intention to Treat: all subjects randomized|||Participants|||Count of Participants
1219314|NCT00738894|Primary|Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)|"Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days.~An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm."|24 months|Intention to Treat: includes all subjects randomized and evaluated for brain infarct|||Participants|||Count of Participants
1219315|NCT00738894|Primary|Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)|A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.|24 months|Intention to Treat: includes all subjects randomized|||Participants|||Count of Participants
1219316|NCT00738881|Secondary|Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST)|Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. The proportion of patients with confirmed CR and PR will be computed within each treatment arm and exact binomial confidence intervals for the true proportion computed. Chi-square test and Fisher’s exact test will be used to compare the response rates between the treatment arms within the subgroups defined by FISH status, IHC, and MUT.|Up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
1219317|NCT00738881|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier survival curves. A 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare overall survival between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups, compare overall and progression free survival between the erlotinib and pemetrexed arms within the subgroups defined on the basis of the epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC), and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences.|Time from randomization to time of death from any cause, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
1220417|NCT00732940|Secondary|Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24||Baseline, 24 weeks|LOCF|||Percentage||Standard Error|Mean
1219319|NCT00738881|Primary|Progression-free Survival (PFS)|Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients ~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.|Time from randomization to the first date of documented disease progression or death, assessed up to 5 years|All the 23 randomized patients are eligible for primary end point analysis using an ITT principle.|||months||95% Confidence Interval|Median
1219320|NCT00738699|Other Pre-specified|Serologic Response Rate|Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.|Length of study|Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.||||||
1219321|NCT00738699|Other Pre-specified|Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)|Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.|Length of study|Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.||||||
1219322|NCT00738699|Secondary|Time to Tumor Response (TTR)|TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.|Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Months||95% Confidence Interval|Median
1219323|NCT00738699|Secondary|Best Overall Response|BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).|Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Percentage of participants|||Number
1219324|NCT00738699|Primary|Overall Survival (OS)|OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.|Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Months||95% Confidence Interval|Median
1219325|NCT00738699|Primary|Progression-Free Survival (PFS)|PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).|Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment.|||Months||95% Confidence Interval|Median
1219326|NCT00738673|Secondary|Kaplan-Meier Estimate for Overall Survival|The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient’s data were censored at the date of last visit.|up to month 12|"Intent to treat population.~Analysis was not performed since no participants died during study."||||||
1219327|NCT00738673|Secondary|Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study|Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.|up to month 12|Intent to treat population|||participants|||Number
1219328|NCT00738673|Secondary|Participants at Testosterone Level <=0.32 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.|||participants|||Number
1219329|NCT00738673|Secondary|Participants at Testosterone Level <=0.2 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.|||participants|||Number
1219330|NCT00738673|Secondary|Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||IU/L||Standard Deviation|Mean
1219331|NCT00738673|Secondary|Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit|LH is measured in IU/L|Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||percentage of baseline||Standard Deviation|Mean
1219332|NCT00738673|Secondary|Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||ng/mL||Standard Deviation|Mean
1219333|NCT00738673|Secondary|Change From Baseline in Serum Levels of Testosterone at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||ng/mL||Standard Deviation|Mean
1219335|NCT00738673|Secondary|Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level.~Per protocol, the two month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 2 months|Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.|||percentage of participants||95% Confidence Interval|Number
1219336|NCT00738673|Secondary|Participants’ Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level.~Per protocol, the one month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 1 month|Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.|||percentage of participants||95% Confidence Interval|Number
1219337|NCT00738673|Primary|Participants’ Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level"|Day 0 (baseline), 3 months|Intent to treat population. Last observation carried forward.|||percentage of participants||95% Confidence Interval|Number
1219338|NCT00738543|Secondary|Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period|Presence of allergy or skin reaction at 24 hours after the application of the antiseptic|24 hours||||Number of participants with reaction|||Number
1219339|NCT00738543|Primary|Bacterial Colony Forming Units for the Control Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
1219340|NCT00738543|Primary|Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
1219341|NCT00738543|Secondary|Presence of Skin Reactions for the 10% Povidone-iodine Period|Presence of allergy or any skin reaction at 24 hours after the antiseptic application|24 hours|A minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL, with a power of 80%, and bilateral error of 5%. Analysis per protocol.|||Number of participants with skin reactio|||Number
1219342|NCT00738543|Primary|Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period|Bacterial colony count of skin cultures to determine antiseptic properties|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
1219343|NCT00738530|Secondary|Change From Baseline in Karnofsky Performance Status|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Week 7, 15, 23, 31, 43|Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.|||score on a scale||Full Range|Median
1219344|NCT00738530|Secondary|Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to mRECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >=30% decrease under baseline of the sum of the LD of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.|||percentage of participants|||Number
1219345|NCT00738530|Secondary|Percentage of Participants With Objective Response According to mRECIST|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.|||percentage of participants|||Number
1219357|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8|Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful erections||95% Confidence Interval|Least Squares Mean
1219435|NCT00737672|Secondary|Circuit Primary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219346|NCT00738530|Secondary|Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to treatment failure was defined as the time between the date of randomization and the date of insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last tumor assessment or last treatment administration, whichever occurred last. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
1219347|NCT00738530|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||percentage of participants|||Number
1219348|NCT00738530|Secondary|Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to progression was defined as the time between date of randomization and date of documented progression. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event (including participants who died before progressive disease) were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
1219349|NCT00738530|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST. Progressive disease was defined as at least a 20 percentage(%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
1219350|NCT00738530|Secondary|Percentage of Participants With Disease Progression or Death|Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||percentage of participants|||Number
1219351|NCT00738530|Primary|Overall Survival (OS) Duration|Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.|Baseline until death (up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
1219352|NCT00738530|Primary|Percentage of Participants Who Died||Baseline up to 4.25 years|ITT population included all participants randomized into the study.|||percentage of participants|||Number
1219353|NCT00738426|Secondary|Changes in Weight, Body Mass Index (BMI) and Scores on the Body Shape Questionnaire (BSQ).||4 weeks|||||||
1219354|NCT00738426|Primary|Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.||2 weeks||||participants|||Number
1219355|NCT00738400|Secondary|Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))|Number of participants with no recorded titration of Vardenafil after visit 3.|week 4 and week 8||||Participants|||Number
1219356|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8|Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful ejaculations||95% Confidence Interval|Least Squares Mean
1240302|NCT00579670|Secondary|"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"||Week 12|FAS|||Participants|||Number
1219358|NCT00738400|Secondary|"Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)"|Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')|up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.|||Percentage of participants|||Number
1219359|NCT00738400|Primary|Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8|Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent erection maintenance||95% Confidence Interval|Least Squares Mean
1219360|NCT00738400|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8|Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful penetrations||95% Confidence Interval|Least Squares Mean
1219361|NCT00738400|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)|The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.|baseline and up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1219362|NCT00738374|Secondary|Disease-Free Survival|The mean time, in days, from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi. In both groups, the mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||days||Standard Error|Mean
1219363|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR/CRi|Disease-free survival was defined at the time from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants with a confirmed CR or CRi were included in the analysis.|||participants|||Number
1219364|NCT00738374|Secondary|Duration of Response|The mean time, in days, from the date of first documented CR, CRi or PR to the date disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||days||Standard Error|Mean
1219365|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR, CRi, or PR|Duration of response was defined as the time from the date of the first documented CR, CRi, or PR to the date of disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||participants|||Number
1219366|NCT00738374|Secondary|OS|The mean time, in days, from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. The mean survival time and it's SE were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||Standard Error|Mean
1219367|NCT00738374|Secondary|Number of Participants Who Died|Overall Survival (OS) was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
1219368|NCT00738374|Secondary|Time to Next Treatment (TTNT)|The mean time, in days, from the date of the first dose of study treatment to the date of new CLL treatment or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. Mean survival time and it's standard error (SE) were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||Standard Error|Mean
1219369|NCT00738374|Secondary|Number of Participants With New CLL Treatment or Death|Time to new CLL treatment (TTNT) was defined as the time from the first dose of study treatment to the date of new CLL treatment received or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
1219370|NCT00738374|Secondary|PFS|The median time, in days, from the date of the first dose of study treatment to the date of first documentation of disease progression or death. CR and PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||95% Confidence Interval|Median
1219371|NCT00738374|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the first dose of study treatment to the first documentation of disease progression or death. PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
1219372|NCT00738374|Secondary|EFS|The median time, in days, from the the date of first dose of study treatment to the date of first documentation of disease progression, relapse for participants with CR, death due to any cause, withdrawal due to AE, or new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose if study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||95% Confidence Interval|Median
1219373|NCT00738374|Secondary|Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment|Event-free Survival (EFS) was defined as the time from the first dose of study treatment to the date of first documentation of disease progression, relapse for participants with previous CR, death due to any cause, withdrawal due to AE, or beginning new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose of study treatment.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
1219374|NCT00738374|Secondary|Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study|Molecular CR was defined as the absence of MRD evaluated in participants who achieved CR by quantitative PCR in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1219375|NCT00738374|Secondary|Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study|Immunophenotypic CR was defined as the absence of MRD evaluated in participants who achieved CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants, only participants with a confirmed CR were included in the analysis.|||percentage of participants|||Number
1219376|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study|CR, CRi, PR, SD, PD, relapse, and nodular PR as previously defined.|Month 35|All randomized participants.|||percentage of participants|||Number
1219377|NCT00738374|Secondary|Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment|Immunophenotypic CR was defined as the absence of minimal residual disease (MRD) evaluated in participants with CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells. Molecular CR was defined as the absence of MRD evaluated in participants with CR by quantitative polymerase chain reaction (PCR) in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 10|ITT population|||participants|||Number
1219378|NCT00738374|Secondary|Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study|CR, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a ≥ 50% increase in greatest diameter of any previously noted lesion; 2) a ≥50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter’s syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 35|All randomized participants who were assessed at Month 35 were included in the analysis.|||percentage of participants|||Number
1219379|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment|CR, CRi, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a greater than or equal to (≥) 50% increase in greatest diameter of any previously noted lesion; 2) a ≥ 50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥ 50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter’s syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥ 6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 10|ITT population|||percentage of participants|||Number
1219406|NCT00737711|Secondary|Mean Serum Bilirubin Over Time|Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
1219380|NCT00738374|Secondary|Percentage of Participants With Documented CR, CRi, or PR at the End of Study|CR defined as: 1) laboratory CR: PBL <4000/μL, PMN > 1500/μL, platelets > 100,000/μL, and Hb > 11 g/dL; 2) clinical CR: LN < 1.5 cm, and no constitutional symptoms, HM or SM; 3) instrumental CR: LN < 1.5 cm and no HM/SM, and 4) bone marrow CR: normocellular aspirate/biopsy for participant age < 30% lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to CLL, with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from BL in the HM/SM, and 1 of the following: PMN > 1500/μL, platelets > 100,000/μL or > 50% improvement from BL, and Hb >11.0 g/dL or > 50% improvement from BL.|Month 35|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1219381|NCT00738374|Primary|Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment|CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (<) 4000/microliter (μL), neutrophils (PMN) greater than (>) 1500/μL, platelets >100,000/μL, and hemoglobin (Hb) >11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) <1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN <1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age <30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN >1500/μL, platelets >100,000/μL or >50% improvement from BL, and Hb >11.0 g/dL or >50% improvement from BL.|Month 10|Intent to treat (ITT) population: all consented participants who received at least 1 dose of rituximab.|||percentage of participants||95% Confidence Interval|Number
1219382|NCT00738361|Secondary|Overall Survival|Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive.|up to 1 year following last treatment, for a total of approximately 5 years||||months||Standard Error|Mean
1219383|NCT00738361|Secondary|Progression-free Survival|Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel|up to 1 year following last treatment, for a total of approximately 5 years|all patients progressed at the time of first scan|||months||95% Confidence Interval|Median
1219384|NCT00738361|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 1 year following last treatment, for a total of approximately 5 years||||patients|||Number
1219385|NCT00738283|Primary|Zinc Absorption|"Zinc fractional absorption was measured using a dual tracer stable isotope method in which 67Zn was given orally with a single feed followed immediately by infusion of 70Zn intravenously. A spot urine sample was collected 96 hours after the infusion and the relative dose-corrected enrichments used to calculate fractional absorption at the time oral isotope was administered.~Tracer:tracee ratios (TTR), measured by ICP-MS, were used to calculated fractional zinc absorption."|96 hours after single feed infusion|Relationships between zinc absorption, zinc excretion (urine or fecal) and zinc balance, and potential explanatory variables were analyzed using the GLM model function of JMP 7 for Macintosh (SAS inc, Cary, NC). Simple and multiple regression analysis were used as appropriate. Significance was assumed at a p < 0.05.|||fractional zinc absorption (%)||Standard Deviation|Mean
1219386|NCT00738062|Secondary|Clinician Rated Clinical Global Impressions - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.~Patients will be grouped according change in disease as follows;~Very Much Improved to Slightly Improved (CGI-I 1-3),~No Change (CGI-I 4),~Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days||||participants|||Number
1219387|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.~Patients will be grouped according change in disease as follows;~Very Much Improved to Slightly Improved (CGI-I 1-3),~No Change (CGI-I 4),~Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days||||participants|||Number
1219388|NCT00738062|Secondary|Clinician Recorded Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2),~Mild-Moderate OH (CGI-S 3-4),~Marked OH-Most Ill with OH (CGI-S 5-7)."|14 days||||participants|||Number
1219389|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2),~Mild-Moderate OH (CGI-S 3-4),~Marked OH-Most Ill with OH (CGI-S 5-7). ."|14 days||||participants|||Number
1219390|NCT00738062|Post-Hoc|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients were on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days||||units on a scale||Standard Deviation|Mean
1219391|NCT00738062|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days||||mmHg||Standard Deviation|Mean
1219756|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Eosinophils|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.|78 weeks|Treated Set with values for Eosinophils|||participants|||Number
1219392|NCT00738062|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score|"The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days||||units on a scale||Standard Deviation|Mean
1219393|NCT00738062|Secondary|Change in Orthostatic Hypotension Daily Activities (OHDAS) Score|"The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days|One droxidopa patient excluded from analysis because data were not evaluable.|||units on a scale||Standard Deviation|Mean
1219394|NCT00738062|Primary|Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization."|14 days|"The analysis population was based on the ITT population of all patients randomized. Last observation carry forward was used for patients who prematurely discontinued the study.~One droxidopa patient was excluded from the analysis because OHQ values were not evaluable."|||units on a scale||Standard Deviation|Mean
1219395|NCT00738049|Secondary|Change During Darusentan Treatment in the Coronary Flow Reserve (CFR)|CFR is calculated as the unitless ratio between hyperemic to resting flow|0, 2, 4, and 6 weeks||||no units||Standard Deviation|Mean
1219396|NCT00738049|Secondary|Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia||0, 2, 4, and 6 weeks||||cc/min/gm||Standard Deviation|Mean
1219397|NCT00738049|Primary|Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity|Markovian homogeneity analysis characterizes an image produced by a PET scan by examining the probability that a pixel with a given intensity will have a neighbor with a different intensity. The homogeneity index ranges from >0 to 1, where a value near 0 represents an image with a high probability that neighboring pixels have intensity values that differ greatly, and a value near 1 represents an image with a high probability that neighboring pixels have similar intensity values.|0, 2, 4, and 6 weeks|Statistical analysis is exploratory, therefore not easily planned. A paired t-test with 40 subjects will provide approximately 89% power to test the null hypothesis of no change in the homogeneity number versus a two-sided alternative at alpha= 5%,if the true mean change is 0.15,e.g.,a homogeneity index of 0.5 at baseline and 0.65 after darusentan.|||No units||Standard Deviation|Mean
1219398|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention|Systolic blood pressure change from baseline during an 48-hour intralipid infusion after taking rosiglitazone for 6 weeks in obese diabetic subjects|48 hours||||mmHg||Standard Error|Mean
1219399|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Saline Infusions|Systolic blood pressure change from baseline during an 48-hour normal saline infusion in obese diabetic subjects|48 hours||||mmHg||Standard Error|Mean
1219400|NCT00738023|Primary|Changes in Systolic Blood Pressure During Initial Intralipid Infusion|Systolic blood pressure change from baseline during an 48-hour intralipid infusion|Baseline, 48 hours||||mmHg||Standard Error|Mean
1219401|NCT00737737|Secondary|Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?||4 weeks||||ng/ml|||Number
1219402|NCT00737737|Primary|Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?||4 weeks||||ng/ml|||Number
1219403|NCT00737711|Secondary|Mean Serum Alkaline Phosphatase Over Time|Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||U/L||Standard Deviation|Mean
1219404|NCT00737711|Secondary|Mean Alanine Aminotransferase Over Time|Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||U/L||Standard Deviation|Mean
1219405|NCT00737711|Secondary|Mean Aspartate Transaminase Over Time|Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Units/Liter (U/L)||Standard Deviation|Mean
1219436|NCT00737672|Secondary|Circuit Primary Patency|"Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.~P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve."|6 months||||Percentage of Subjects||95% Confidence Interval|Number
1219407|NCT00737711|Secondary|Mean Serum Phosphate Over Time|Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
1219408|NCT00737711|Secondary|Mean Serum Sodium Over Time|Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mmol/L||Standard Deviation|Mean
1219409|NCT00737711|Secondary|Mean Serum Potassium Over Time|Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1219410|NCT00737711|Secondary|Mean Blood Urea Nitrogen Over Time|Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
1219411|NCT00737711|Secondary|Mean Serum Creatinine Over Time|Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
1219412|NCT00737711|Secondary|Mean Serum Globulin Over Time|Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||g/dL||Standard Deviation|Mean
1219413|NCT00737711|Secondary|Mean Serum Albumin Over Time|Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||g/dL||Standard Deviation|Mean
1219414|NCT00737711|Secondary|Mean Transferrin Saturation Over Time|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Percentage of transferrin saturation||Standard Deviation|Mean
1219415|NCT00737711|Secondary|Mean Total Iron-binding Capacity Over Time|Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mcg/dL||Standard Deviation|Mean
1219416|NCT00737711|Secondary|Mean Transferrin Over Time|Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1219417|NCT00737711|Secondary|Mean Serum Ferritin Over Time|Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||nanogram /milliliter (ng/mL)||Standard Deviation|Mean
1219418|NCT00737711|Secondary|Mean Serum Iron Over Time|Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||microgram/deciliter (mcg/dL)||Standard Deviation|Mean
1219419|NCT00737711|Secondary|Mean Platelet Count Over Time|Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
1219420|NCT00737711|Secondary|Mean Hypochromic Red Blood Cells Over Time|Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
1219421|NCT00737711|Secondary|Mean Value of Mean Corpuscular Volume Over Time|Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Femtoliter||Standard Deviation|Mean
1219422|NCT00737711|Secondary|Mean White Blood Cell Count Over Time|The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
1219423|NCT00737711|Secondary|Number of Participants With Reports of Anti-Epoetin Antibodies|Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug.|||Participants|||Number
1219424|NCT00737711|Secondary|Number of Participants With Reports of Blood Transfusions|Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included.|||Participants|||Number
1219425|NCT00737711|Secondary|Number of Participants With Abnormal Electrocardiogram|Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.|Up to Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Participants|||Number
1219426|NCT00737711|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 18|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number.|||Participants|||Number
1219427|NCT00737711|Secondary|Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
1219428|NCT00737711|Secondary|Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10–12 g/dL) during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||Weeks||Standard Deviation|Mean
1219429|NCT00737711|Secondary|Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter|Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.|Up to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||Weeks||Standard Deviation|Mean
1219430|NCT00737711|Primary|Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period|The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.|Baseline (Week 0) and Week 16|The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||gram/deciliter (g/dL)||Standard Deviation|Mean
1219431|NCT00737672|Secondary|Procedural Success|Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.|Following Index Procedure||||Participants|||Number
1219432|NCT00737672|Secondary|Anatomic Success|Less than 30 percent residual stenosis following study treatment (Index Procedure).|Index Procedure||||Participants|||Number
1219433|NCT00737672|Secondary|Clinical Success|The resumption of normal dialysis for at least one session following study treatment (Index Procedure).|Following Index Procedure||||Participants|||Number
1219434|NCT00737672|Secondary|Circuit Primary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219437|NCT00737672|Primary|Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure|The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.|30 days||||Participants|||Number
1219438|NCT00737672|Primary|Target Lesion Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~P-Value calculated from 24-month data cohort after study completion."|24 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219439|NCT00737672|Secondary|Access Secondary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219440|NCT00737672|Secondary|Access Secondary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219441|NCT00737672|Secondary|Access Secondary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Six-month estimate of secondary access patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219442|NCT00737672|Secondary|Assisted Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219443|NCT00737672|Secondary|Assisted Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219444|NCT00737672|Secondary|Assisted Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Six-month estimate of assisted primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219445|NCT00737672|Primary|Target Lesion Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|12 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219446|NCT00737672|Primary|Target Lesion Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1219447|NCT00737633|Secondary|Percent Weight Change From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)|||percent change||Standard Deviation|Mean
1219448|NCT00737633|Primary|Change in HbA1c From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)|||percent change||Standard Deviation|Mean
1219449|NCT00737594|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment|Study terminated early, data was not analyzed.|4 weeks|||||||
1219450|NCT00737568|Secondary|Development of Drug-resistant Mutations (DRMs)|The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.|Baseline to Week 240|Full Analysis Set|||participants|||Number
1219451|NCT00737568|Secondary|Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set with hip BMD measurements at the given time point were included in the analysis.|||percentage change||Standard Deviation|Mean
1219452|NCT00737568|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as grams per cubic centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) with spine BMD measurements at the given time point were included in the analysis.|||percentage change||Standard Deviation|Mean
1219453|NCT00737568|Secondary|Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240|The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being < 400 copies/mL.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis.|||percentage of participants|||Number
1219454|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240|The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1220442|NCT00732875|Primary|Number of Subjects Experiencing Any Adverse Event||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.|||participants|||Number
1219455|NCT00737568|Secondary|Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1219456|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.|||percentage of participants|||Number
1219457|NCT00737568|Secondary|Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.|||percentage of participants|||Number
1219458|NCT00737568|Secondary|Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240|Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1219459|NCT00737568|Secondary|HBV DNA Level at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis.|||log10 copies/mL||Standard Deviation|Mean
1219460|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1219461|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240||Weeks 48, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1219462|NCT00737568|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
1219463|NCT00737529|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|From the first dose of lenalidomide through 28 days after the last dose during the follow-up phase; median (minimum, maximum) duration of treatment was 94.0 (1.0, 1950 days)|The safety population received at least one dose of lenalidomide was used for all safety analysis. This was identical to the ITT population.|||participants|||Number
1219464|NCT00737529|Secondary|Overall Survival (OS)|Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.|From Day 1 of study drug to first documented date of progressive disease or death; up to the final data cut-off date of 30 March 2017; median duration of follow-up for surviving participants was 62.94 months|Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
1219465|NCT00737529|Secondary|Time to Complete Response (CR+CRu) According to the Independent Review Committee|Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.|From Day 1 of study drug to first documented CR/CRu or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days|Included participants from the ITT population who achieved a CRu or better.|||months||Full Range|Median
1219466|NCT00737529|Secondary|Time to Response (TTR)|Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.|From Day 1 of study drug to time of first documented PR or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days|Included participants from the ITT population who achieved a PR or better.|||months||Full Range|Median
1219467|NCT00737529|Secondary|Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee|Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.|From Day 1 of study drug to first documented time of treatment failure; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days|Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
1219485|NCT00737477|Secondary|Percentage of Participants With Hb Values Within Target Range During the EEP|During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data for at least one Hb value. The number of participants who provided sufficient data for each analysis (n) is shown in the table."|||percentage of participants|||Number
1219468|NCT00737529|Secondary|Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee|Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir|From Day 1 of study drug to first documented time of progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months|Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
1219469|NCT00737529|Secondary|Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee|Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.|From Day 1 of study drug to first documented date of disease progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months|Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
1219470|NCT00737529|Secondary|Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee|Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.|From Day 1 of study drug to progression or early discontinuation; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months|Includes participants from the ITT population who achieved a CRu or better.|||months||95% Confidence Interval|Median
1219471|NCT00737529|Secondary|Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee|The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow.|From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days|The ITT population was defined as all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1219472|NCT00737529|Primary|Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee|Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.|From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days.|Includes participants from the ITT population who achieved a PR or better.|||months||95% Confidence Interval|Median
1219473|NCT00737529|Primary|Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC)|Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.|From Day 1 of study treatment to progession or early treatment discontinuation; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days.|ITT population defined as all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1219474|NCT00737477|Secondary|Percentage of Participants Requiring Blood Transfusions|The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.|Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants|||Number
1219475|NCT00737477|Secondary|Percent Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."|||percent change in dose||Standard Deviation|Mean
1219667|NCT00736385|Secondary|Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1219476|NCT00737477|Secondary|Absolute Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."|||mcg||Standard Deviation|Mean
1219477|NCT00737477|Secondary|Number of Dose Adjustments of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."|||dose adjustments||Standard Deviation|Mean
1219478|NCT00737477|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis within each timeframe (n) is shown in the table."|||percentage of participants|||Number
1219479|NCT00737477|Secondary|Percentage of Participants With Down Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one down excursion."|||percentage of participants|||Number
1219480|NCT00737477|Secondary|Percentage of Participants With Up Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one up excursion."|||percentage of participants|||Number
1219481|NCT00737477|Secondary|Percentage of Participants With Cycles or Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated."|Weeks 4 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants|||Number
1219482|NCT00737477|Secondary|Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit.|Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data at each timepoint (n) is shown in the table."|||percentage of participants|||Number
1219483|NCT00737477|Secondary|Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks.|Weeks 16 to 24 and Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."|||weeks||Standard Deviation|Mean
1219484|NCT00737477|Secondary|Change in Hb Value From Baseline to the EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|Baseline and Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||g/dL||Standard Deviation|Mean
1219668|NCT00736385|Secondary|Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1219486|NCT00737477|Primary|Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants||95% Confidence Interval|Number
1219487|NCT00737464|Secondary|Mean Values of Serum Sodium and Serum Potassium Over Time|Mean values of serum sodium and serum potassium were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||millimole per liter||Standard Deviation|Mean
1219488|NCT00737464|Secondary|Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time|Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||miligram per deciliter||Standard Deviation|Mean
1219489|NCT00737464|Secondary|Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time|Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||units per litre||Standard Deviation|Mean
1219490|NCT00737464|Secondary|Mean Values of Serum Albumin and Serum Globulin Over Time|Mean values of serum albumin and serum globulin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||gram per deciliter||Standard Deviation|Mean
1219491|NCT00737464|Secondary|Mean Values of Transferrin Saturation Over Time|Mean values of Transferrin Saturation (TSAT) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Percentage||Standard Deviation|Mean
1219492|NCT00737464|Secondary|Mean Values of Transferrin Over Time|Mean values of transferrin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||miligram per mililiter||Standard Deviation|Mean
1219493|NCT00737464|Secondary|Mean Values of Serum Ferritin Over Time|Mean values of serum ferritin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||nanogram per mililiter||Standard Deviation|Mean
1219494|NCT00737464|Secondary|Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time|Mean values of serum iron and total iron binding capacity (TIBC) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||microgram per deciliter||Standard Deviation|Mean
1219495|NCT00737464|Secondary|Mean Corpuscular Volume Levels Over Time|Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||femtoliters||Standard Deviation|Mean
1219496|NCT00737464|Secondary|Mean Values of Hypochromic Red Blood Cells Over Time|Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Percentage of RBCs||Standard Deviation|Mean
1219497|NCT00737464|Secondary|Mean Values of White Blood Cells and Platelets Over Time|Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Per cubic millimeter||Standard Deviation|Mean
1219498|NCT00737464|Secondary|Number of Participants With Abnormal Electrocardiogram|Participants with abnormal electrocardiogram were reported.|At Week -2 and Week 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.|||Number of participants|||Number
1219499|NCT00737464|Secondary|Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time|Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.|From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.|||mmHg||Standard Deviation|Mean
1219500|NCT00737464|Secondary|Mean Change From Baseline in Heart Rate Over Time|Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.|From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Beats per minute (bpm)||Standard Deviation|Mean
1219501|NCT00737464|Secondary|Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths|Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|Safety population included all enrolled participants who received at least one dose of study drug.|||Number of participants|||Number
1219502|NCT00737464|Secondary|Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL|Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.|Up to Week 12|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||Weeks||Standard Deviation|Mean
1219503|NCT00737464|Secondary|Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)|The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||gm/dL||Standard Deviation|Mean
1219504|NCT00737464|Primary|Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)|Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 – 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|Weeks 8 to 12 (Last 4 weeks of treatment period)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||Percentage of participants||95% Confidence Interval|Number
1219505|NCT00737438|Primary|Overall Response Will be Characterized by the Patient's FDG-PET Scan|A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline.|2 years||||participants|||Number
1219506|NCT00737360|Secondary|Safety|Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.|Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.|All patients who received at least 1 dose of TAS-106 were the primary population for the safety evaluation.|||number of participants|||Number
1219507|NCT00737360|Secondary|Overall Survival|Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.|12 months after enrollment of the last patient||||day||95% Confidence Interval|Median
1219508|NCT00737360|Secondary|Antitumor Activity|"Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR., or similar text that was as accurate and appropriate."|Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.|Antitumor activity was the rate of best overall objective responses(complete response + partial response).|||participants|||Number
1219509|NCT00737360|Primary|Progression Free Survival(PFS)|PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.|From the date of registration until the earliest date of documented disease progression, death, or censoring event.|One patient enrolled was discontinued without any post-baseline tumor assessment, therefore, 26 patients were included in the efficacy analyzes.|||day||95% Confidence Interval|Median
1219510|NCT00737282|Primary|To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)||12 months|Study prematurely terminated||||||
1219511|NCT00737243|Secondary|Number of Participants With a Tissue of Origin Successfully Predicted by the Assay|To evaluate the utility of the assay in identifying the tissue of origin in patients with carcinoma of unknown primary site (CUP), an archived tumor specimen was assayed upon study entry. If a tissue of origin was predicted by the assay, participants received standard site-specific therapy for that tumor type. When tissue of origin was not predicted by the assay, patients received standard empiric chemotherapy for CUP and were not followed further. If the assay was not completed due to inadequate amount of tumor in the biopsy specimen, patients were not treated on the study.|at baseline|Of 252 participants analyzed, the assay correctly predicted the tissue of origin in 247 patients (98%). The predicted tissue of origin could not be determined in 5 participants (2%).|||participants|||Number
1219512|NCT00737243|Primary|Overall Survival|Defined as the elapsed time from the start of treatment to the date of death from any cause or lost to follow-up. Participants lost to follow up were censored as of the last date known to be alive.|every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months|Of 223 treated patients: 194 received assay-directed therapy; 29 received empiric CUP therapy. The 194 patients who received assay-directed therapy were separated into groups based on predicted responsiveness of the tumor type for further analysis.|||months||95% Confidence Interval|Median
1219513|NCT00737204|Secondary|HIV Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Log10 copies/mL||Standard Deviation|Mean
1223628|NCT00711009|Secondary|Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1219514|NCT00737204|Secondary|CD4 Cell Count|Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >=100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Cells/mcL||Standard Deviation|Mean
1219515|NCT00737204|Primary|Role Function Scale|The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.|Measured at Baseline and Week 4|The week 4 outcome analyses are based on an intention to treat sample, which includes the 6 dropouts, using the last data point brought forward.|||units on a scale||Standard Deviation|Mean
1219516|NCT00737204|Primary|Fatigue Severity Scale(FSS) Outcome|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.|Measured at baseline and Weeks 4|Of the 70 patients randomized, 64 completed the 4-week trial. Data presented are for the 70, using the last data point carried forward (intention to treat).|||units on a scale||Standard Deviation|Mean
1219517|NCT00737178|Primary|Use of the IUD for Contraception at Six Months|Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).|6 months||||participants|||Number
1219518|NCT00737178|Secondary|Expulsion and Removal Rates|"Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study.~Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study."|Within six months of medication abortion|Per protocol: insertion and removal rates were calculated only for participants undergoing IUD insertion|||participants|||Number
1219519|NCT00737178|Secondary|Insertion Rates|Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.|By six months after medication abortion||||participants|||Number
1219520|NCT00737100|Secondary|Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation|Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.|From first drug administration until 30 days after last drug administration (up to 121 days)|Treated set|||participants|||Number
1219521|NCT00737100|Secondary|Time From Dosing to the Maximum Concentration (Tmax,ss)|Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||h||Full Range|Median
1219522|NCT00737100|Secondary|Maximum Measured Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1219523|NCT00737100|Secondary|Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)|Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||ng||Geometric Coefficient of Variation|Geometric Mean
1219524|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Parent Questionnaire|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
1219525|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adolescents Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
1219526|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adult Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
1219527|NCT00737100|Secondary|Respiratory and Systemic Symptoms Questionnaire (RSSQ)|Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Participants|||Number
1219528|NCT00737100|Secondary|Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12|Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1220535|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|12 months post-surgery||||"% responding yes and probably"|||Number
1219529|NCT00737100|Secondary|Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12|Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1219530|NCT00737100|Secondary|Percent Predicted FVC Trough Response at the End of Week 12|Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1219531|NCT00737100|Secondary|Percent Predicted FVC AUC0-4 Response at the End of Week 12|Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1219532|NCT00737100|Primary|Percent Predicted FEV1 Trough Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1219533|NCT00737100|Primary|Percent Predicted FEV1 AUC0-4 Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1219534|NCT00737061|Secondary|3 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.|3 years|Population includes all participants able to rely on Adiana (n=570). This analysis is cumulative and based on survival analysis methodology. Thus, participants only followed for 2 years, for example, would still be included in this cumulative analysis. In total, 481 participants were available with 3 years of follow-up at the time of analysis.|||percentage of participants|||Number
1219535|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum comfort reported at 12-Months as 530/532 participants.|||percentage of participants|||Number
1219536|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum comfort reported at 1-Month as 604/608 participants.|||percentage of participants|||Number
1219537|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.|48 hours|Intent to treat population; no imputations for missing data. Minimum comfort reported as 578/632 participants.|||percentage of participants|||Number
1219538|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.|Post-Procedure|Intent to treat population; no imputations for missing data. Minimum comfort reported as 504/629 participants.|||percentage of participants|||Number
1219539|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum satisfaction reported at 12-Months as 528/531 participants.|||percentage of participants|||Number
1219540|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum satisfaction reported at 2-Months as 587/613 participants.|||percentage of participants|||Number
1219541|NCT00737061|Secondary|Patient Satisfaction With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.|48 hours|Intent to treat population; no imputations for missing data. Minimum satisfaction reported as 605/625 participants.|||percentage of participants|||Number
1219542|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|Including Second Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 611/645 participants after 7 participants underwent a successful second attempt.|||percentage of participants|||Number
1219543|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|After First Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 604/645 participants after the first procedure.|||percentage of participants|||Number
1240303|NCT00579670|Secondary|"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?"||Week 12|FAS|||Participants|||Number
1219544|NCT00737061|Primary|1 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.|1 year|645 participants had treatment attempted; Intent to Treat population. Of these 645, 570 were able to rely on the device and are used to evaluate the pregnancy prevention rate for the 1-year endpoint. During the 1-year follow-up period, there were 6 pregnancies, of which 3 were attributable to physician error, i.e., misinterpretation of HSG results.|||percentage of participants|||Number
1219545|NCT00737048|Secondary|Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain|"Percentage of participants were assessed with treatment response based on evaluation criteria for efficacy of analgesics in post-tooth-extraction pain for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as very effective, effective, somewhat effective and ineffective for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as extremely useful, useful, not useful & could not be assessed for overall evaluation (OE)."|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Percentage of participants|||Number
1219546|NCT00737048|Secondary|Number of Participants Treated With a Relief Analgesic|Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Participants|||Number
1219547|NCT00737048|Secondary|Percentage of Participants With Categorical Score for Patient Impressions|Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn’t work.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Percentage of participants|||Number
1219548|NCT00737048|Secondary|Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy|Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Minutes||Standard Deviation|Mean
1219549|NCT00737048|Secondary|Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1219550|NCT00737048|Secondary|Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1219551|NCT00737048|Secondary|Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment|The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1219552|NCT00737048|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1219553|NCT00737048|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)|The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1219554|NCT00737048|Secondary|Sum of Pain Intensity Difference (SPID)|Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1219555|NCT00737048|Secondary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1219556|NCT00737048|Primary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|8 hours|Final analysis set (FAS) population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1219557|NCT00736996|Secondary|Change in Peak Oxygen Uptake (VO2 Peak)|Peak oxygen consumption (VO2 peak, ml/kg/min) was determined by open circuit spirometry during a standard treadmill stress test (modified Balke protocol).|Baseline to 6 months||||ml/kg/min||95% Confidence Interval|Number
1219558|NCT00736996|Secondary|Change in Insulin Resistance|Change in whole body glucose disposal rate (mg/kg/min) calculated during a single-stage (40 mU/m2/min), 3-hour hyperinsulinemic, euglycemic clamp|Baseline to 6 months||||mg/kg/min||95% Confidence Interval|Number
1219559|NCT00736996|Primary|Change in Cognitive Performance|Participants were administered a neuropsychological testing battery consisting of assessments in four cognitive domains: memory (Visual Reproduction II, Logical Memory II, Rey Auditory Verbal Learning Test), language (Boston Naming Test , Category Fluency), visuospatial (Block Design, Picture Completion), and executive function (Trail Making Test B, Digit Symbol Test). Raw test scores for these primary cognitive domain measures were transformed into age-adjusted scaled scores with a mean of 10 and a standard deviation (SD) of 3, with higher numbers indicating better cognitive performance, using the Mayo’s Older American Normative Studies data. Cognitive domain scores were calculated as the arithmetic mean of the normatively derived scaled scores for all of the tests in that domain.|Baseline to 6 months||||units on a scale||95% Confidence Interval|Number
1219560|NCT00736957|Secondary|Change From Baseline in Short Form-36 (SF-36) Score|SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status.|Baseline, Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure and n = the number of participants with measurements for that time point.|||units on a scale||Standard Deviation|Mean
1219561|NCT00736957|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4|PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on scale||Standard Deviation|Mean
1219562|NCT00736957|Secondary|Pain Relief (PAR) Score at Week 4|Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1219563|NCT00736957|Secondary|Pain Intensity Difference (PID) at Week 4|PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1219564|NCT00736957|Secondary|Number of Participants With Improvement From Baseline in VAS24 Score|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Last Observation Carried Forward (LOCF) method was used.|||participants|||Number
1219565|NCT00736957|Primary|Change From Baseline in VAS24 Score at Week 52|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.|||millimeter||Standard Deviation|Mean
1223629|NCT00711009|Secondary|Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1219566|NCT00736957|Primary|Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4|Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.|||millimeter||Standard Deviation|Mean
1219567|NCT00736944|Secondary|Progression-free Survival|Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
1219568|NCT00736944|Secondary|Disease Free Survival|Time from complete response to death from any cause, to disease progression or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
1219569|NCT00736944|Secondary|Overall Survival|Time from diagnosis to death or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
1219570|NCT00736944|Secondary|Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis||completion of the first 10 patients induction chemotherapy||||participants|||Number
1219571|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.|||participants|||Number
1219572|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.|||participants|||Number
1219573|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.|||participants|||Number
1219574|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.|||participants|||Number
1219575|NCT00736944|Secondary|Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|1 patient was not evaluable for CT scan because the primary site could not be clearly measured and was noted as non-target lesion. 1 patient was not evaluable for PET scan because the patient's insurance company denied coverage.|||percentage of participants|||Number
1219576|NCT00736944|Secondary|Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|12 patients were not evaluable for VSR because they did not have nodal disease. 6 patients were not evaluable for CT scan because 5 patients did not have nodal disease and 1 patient didn't have measurable nodal disease. 5 patients were not evaluable for PET because 5 patients did not have nodal disease.|||percentage of participants|||Number
1219577|NCT00736944|Secondary|Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|"In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests.~We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|2 patients were not evaluable for the CT Scan of this outcome because they did not have primary disease that could be measured per RECIST. 2 patients were not evaluable for PET scan of this outcome because one patient's insurance company denied coverage and the other patient did not have primary site disease.|||percentage of participants|||Number
1219578|NCT00736944|Secondary|Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient had primary site disease that could not be clearly measured per CT and was listed as a non-target lesion.|||participants|||Number
1219579|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Six patients were not evaluable for this outcome. Five of these patients did not have any involved lymph nodes available to evaluate. The sixth patient did not have involved lymph nodes that were clearly measurable by CT and RECIST.|||participants|||Number
1219580|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. The first patient didn't have primary site disease that could be measured by RECIST. The second patient had primary site disease but it could not be clearly measured by CT. This disease was noted as a non-target lesion as present at baseline.|||participants|||Number
1219581|NCT00736944|Other Pre-specified|Overall Complete and Partial Response Rates by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient's insurance company denied coverage for the post-cycle 2 timepoint and because of this was not included in this overall response rate for PET scan.|||participants|||Number
1219582|NCT00736944|Secondary|Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Five patients were not evaluable for this outcome because these patients did not have any involved lymph nodes that could be measured.|||participants|||Number
1219583|NCT00736944|Secondary|Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. One patient's insurance company denied coverage for the PET scan so the PET scan was not performed. The other patient only had neck nodes that were clearly measurable on the PET scan, the primary site could not be measured on the PET scan.|||participants|||Number
1219584|NCT00736944|Secondary|Clinical Overall Complete and Partial Response Rates|"Clinical exam included laryngoscopy in office or operating room.~Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days)||||participants|||Number
1219585|NCT00736944|Secondary|Clinical Complete and Partial Response Rates to the Involved Regional Nodes|"Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Twelve patients were not evaluable because of initial absence of nodal disease on clinical exam.|||participants|||Number
1219586|NCT00736944|Secondary|Clinical Partial Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.~Partial response rate (PR) defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Participants who completed 2 cycles of induction therapy|||participants|||Number
1219587|NCT00736944|Primary|Clinical Complete Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size."|post-2 cycles of induction (approximately 42 days from start of treatment)|All patients who completed 2 cycles of induction therapy.|||participants|||Number
1219588|NCT00736879|Secondary|Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants|Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX, >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.|Baseline to Week 24/end of treatment plus 4 days|N=Number of participants who received at least 1 dose of study medication and had non-missing laboratory results.|||participants|||Number
1219669|NCT00736385|Secondary|Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1219589|NCT00736879|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants|12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline (BL) and Week 24 (LOCF) values.|||participants|||Number
1219590|NCT00736879|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants|Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||bpm||Standard Error|Mean
1219591|NCT00736879|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants|Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Participants who took at least 1 dose of double-blind study medication were analyzed. n= number of treated participants with non-missing baseline and Week 24 values.|||mmHg||Standard Error|Mean
1219592|NCT00736879|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs summarized below were prior to rescue.|||participants|||Number
1219593|NCT00736879|Secondary|Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.|||participants|||Number
1219594|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants|Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||cm||Standard Error|Mean
1219595|NCT00736879|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Baseline (Day 1), Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.|||Adjusted Percentage of participants|||Number
1219604|NCT00736853|Secondary|Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219596|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants|Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Mean
1219597|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Mean
1219598|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||kg||Standard Error|Mean
1219599|NCT00736879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants|Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||Percent Hemoglobin||Standard Error|Mean
1219600|NCT00736853|Secondary|Change From Baseline in SF-36 at Day 28 of Double-Blind Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219601|NCT00736853|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1219602|NCT00736853|Secondary|Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219603|NCT00736853|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1219605|NCT00736853|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1219606|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219607|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief.|Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
1219608|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Double-Blind Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219609|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Open-Label Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1 and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
1219610|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219611|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, and Day 8 of open-label period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1219612|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219613|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study medication. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
1219614|NCT00736853|Secondary|Mean PAR Score During the Double-Blind Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219615|NCT00736853|Secondary|Mean Pain Relief (PAR) Score During the Open-Label Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1219616|NCT00736853|Secondary|Mean PID During the Double-Blind Period|The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219617|NCT00736853|Secondary|Mean Pain Intensity Difference (PID) During the Open-Label Period|The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1219618|NCT00736853|Secondary|Mean PI Score During Double-Blind Period|The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1219619|NCT00736853|Secondary|Mean Pain Intensity (PI) Score During Open-Label Period|PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1219620|NCT00736853|Secondary|Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.|||mm||Standard Deviation|Mean
1219621|NCT00736853|Secondary|Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 of open-label period and Day 1 of double-blind period|Efficacy analysis set included participants who received at least one dose of study drug.|||mm||Standard Deviation|Mean
1219622|NCT00736853|Primary|Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period|The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.|Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.|||number of participants|||Number
1219623|NCT00736840|Secondary|AUC of ROC (Area Under Receiver Operating Characteristic Curve)|The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy.|At study day 1 after 1 hour test||||Probability||95% Confidence Interval|Mean
1219624|NCT00736840|Primary|"Number of Subjects With Likelihood of Cirrhosis Based on Hepatic Impairment Score (HIS)"|"Hepatic Impairment Score (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard."|Study day 1 after a 1 hour test|The primary efficacy was conducted on all evaluable subject data in the full analysis (FA)set with biopsy confirmed cirrhosis.|||Participants|||Number
1219625|NCT00736723|Primary|Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes|maximal NT-proBNP concentrations in critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealingnonseptic and septic shock|01 July 2008 to 31 Dec 2008||||pg/ml||Full Range|Median
1219626|NCT00736645|Secondary|Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction|Compare cleaved caspase 3 values with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of cleaved caspase 3 values of Arm A, Arm B, Arm D with Arm C.|1 year|All treated and eligible patients|||percentage of apoptotic cells||Full Range|Median
1219627|NCT00736645|Primary|Effects of Selenium and Finasteride and Their Combination on PSA Level|Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C.|1 year|All treated and eligible patients|||ng/mL||Full Range|Median
1219631|NCT00736502|Secondary|Virologic Response (VR)|VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.|48 weeks|TS|||Participants|||Number
1219632|NCT00736502|Primary|Proportion of Patients Reporting Adverse Events|the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.|48 weeks|The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.|||Percentage of participants|||Number
1219633|NCT00736489|Secondary|Plasma AZD3199 AUC0-24|Area under the plasma concentration curve from time 0 to 24 h post-dose|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.|||nmol*h/L||Full Range|Geometric Mean
1219634|NCT00736489|Secondary|Plasma AZD3199 Cmax|Maximum plasma concentration of AZD3199 measured|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.|||nmol/L||Full Range|Geometric Mean
1219635|NCT00736489|Secondary|Palpitations, Average Effect Over 0 - 4 h Post-dose|Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
1219636|NCT00736489|Secondary|Palpitations, Peak Effect Over 0 - 4 h Post-dose|Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
1219637|NCT00736489|Secondary|Tremor, Average Effect Over 0 - 4 h Post-dose|Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
1219638|NCT00736489|Secondary|Tremor, Peak Effect Over 0 - 4 h Post-dose|Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
1219639|NCT00736489|Secondary|QTcB, Average Effect Over 0 - 4 h Post-dose|Average QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||ms||Standard Deviation|Mean
1219640|NCT00736489|Secondary|QTcB, Peak Effect Over 0 - 4 h Post-dose|Maximum QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||ms||Standard Deviation|Mean
1219641|NCT00736489|Secondary|Heart Rate, Average Effect Over 0 - 4 h Post-dose|Average heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
1219642|NCT00736489|Secondary|Heart Rate, Peak Effect Over 0 - 4 h Post-dose|Maximum heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
1219643|NCT00736489|Secondary|Pulse, Average Effect Over 0 - 4 h Post-dose|Average pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
1219644|NCT00736489|Secondary|Pulse, Peak Effect Over 0 - 4 h Post-dose|Maximum pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
1219645|NCT00736489|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
1219646|NCT00736489|Secondary|Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Minimum DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
1219647|NCT00736489|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
1219648|NCT00736489|Secondary|Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Maximum SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
1219716|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Cholesterol|||participants|||Number
1219649|NCT00736489|Secondary|FEV1 Average Effect Over 12 - 24 h Post-dose|FEV1 average effect over 12 h night-time period|12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1219650|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 12 h Post-dose|FEV1 average effect over 12 h day-time period|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1219651|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 24 h Post-dose|FEV1 average effect over 24 h dosing interval|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1219652|NCT00736489|Secondary|FEV1 Effect at 5 Min Post-dose|FEV1 at 5 minutes|5min|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on Placebo and 1 on AZD3199 480 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1219653|NCT00736489|Primary|S-potassium, Average Effect Over 0 - 4 h Post-dose|Average S-potassium concentration|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||mmol/L||Standard Deviation|Mean
1219654|NCT00736489|Primary|S-potassium, Peak Effect Over 0 - 4 h Post-dose|Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||mmol/L||Standard Deviation|Mean
1219655|NCT00736489|Primary|E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.|Residual FEV1 24 h post-dose|22- 26 h post dose|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1219656|NCT00736489|Primary|FEV1 Peak Effect Within 0 - 24 h Post-dose|Maximum FEV1 value|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1219657|NCT00736476|Secondary|Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)|The proliferation of H. pylori-specific Peripheral blood mononuclear cells (PBMCs) following HP antigen stimulation was assessed to measure the magnitude of the cell mediated immune response.|12 weeks post HP challenge|Per-protocol dataset|||Stimulation Index (SI)||Standard Deviation|Mean
1219658|NCT00736476|Secondary|Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge|The response to 3 doses of HP vaccine and the oral HP challenge was assessed with respect their ability to induce differentiation and changes in the phenotype of a subset of regulatory T-cells CD4+CD25+Foxp3+ that expresses Treg Markers PD-1 and/or HLA-DR.|12 weeks post HP challenge|Per-protocol dataset|||percentage of T-cells||Standard Deviation|Mean
1219659|NCT00736476|Secondary|Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.|The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP) after HP challenge were compared between vaccinated and placebo groups.|12 months|Per-protocol dataset|||μg/mL||95% Confidence Interval|Geometric Mean
1219660|NCT00736476|Secondary|The Geometric Mean Concentrations After HP Vaccination.|The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP)after HP vaccination as compared to placebo are reported.|upto 1 month after 3rd vaccination|Per-Protocol dataset|||μg/mL||95% Confidence Interval|Geometric Mean
1219661|NCT00736476|Secondary|The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups|The time course of HP infection following HP challenge in subjects of the HP vaccine and placebo groups, were assessed by non-invasive HP tests.|12 months||||Participants|||Number
1219662|NCT00736476|Primary|Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination|To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local* and systemic adverse events.|Day 1-7 post vaccination|This analysis was done on the safety dataset|||Participants|||Number
1219663|NCT00736476|Primary|The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.|"The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo).~Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT)."|12 weeks post HP challenge|Per-protocol dataset|||Percentage of subjects|||Number
1219664|NCT00736450|Secondary|Efficacy of Treatment, in Terms of Complete Response Rate (Anyone Achieving a CR or Cru)|Response criteria are the recommendations of the International Harmonization Project’s update to the International Working Group guidelines. Complete response (CR) is defined as disappearance of all evidence of disease; Partial response (PR) is defined as regression of measurable disease and no new sites|End of treatment, an average of 4 months||||Participants|||Count of Participants
1219670|NCT00736385|Primary|Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1219671|NCT00736333|Primary|Number of Times Premedications Were Given for Prevention of PPE|Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.|Day 1 up to 24 weeks|Safety population (those who received at least one dose of study medication)|||Number of times premedication was given|||Number
1219672|NCT00736333|Primary|Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)|PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.|Up to 24 weeks|Safety population (those who received at least one dose of study medication)|||Occurrences|||Number
1219673|NCT00736333|Primary|Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR|Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.|Cycles 1 & 3 (Week 4 & Week 12)|Safety population (those who received at least one dose of study medication)|||Participants|||Number
1219674|NCT00736333|Primary|Percent of Participants Taking Premedication for Prevention of IR|Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.|Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin|Safety population (those who received at least one dose of study medication)|||Percent of participants|||Number
1219675|NCT00736333|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|CR and PR were documented according to the clinical standards of each site.|Day 1 up to 24 weeks|Intent-to-treat (those who received at least one dose of study medication)|||Participants|||Number
1219676|NCT00736333|Primary|Number of Participants With Infusion Reactions (IR)|Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.|Day 1 up to Week 24|Safety population (those who received at least one dose of study medication)|||Participants|||Number
1219677|NCT00736255|Secondary|Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. 1-Very Much Improved through 7-Very Much Worse.|Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)||||score on a scale||Standard Deviation|Mean
1219678|NCT00736255|Secondary|N-back Test Proportion Correct Across 4 Load Factors|This is measured by the N-Back test, a cognitive functioning, including working memory test. The test is designed with 4 Load Factors, where the current stimulus matches the one from 'n' steps back or prior in the sequence. The load factor n is adjusted so there is a 'O-back' (i.e. 'n-0'), '1-back' (i.e. 'n-1'), '2-back' (i.e. 'n-2'), and '3-back' (i.e. 'n-3'). When the correct stimulus appears on the screen, the participant then responds on the computer. Missing the stimulus decreases the proportion correct.|Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)||||proportion correct to stimuli response||Standard Deviation|Mean
1219679|NCT00736255|Secondary|ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms|"T-scores derived from compiled ADHD symptoms from two forms. Specifically the t-scores for the DSM-IV Total subscale, representing ADHD symptoms. This is conducted by the participant and clinician at randomization, visits 2 and 4 (i.e. dose titration visits), Visit 6 (i.e. monitoring visit), and Visit 8 (i.e. final/end of study visit).~The following describes severity of the ADHD symptoms (based upon T-Score):~70+ = Very Much Above Average 66-70 = Much Above Average 61-65 = Above Average 56-60 = Slightly Above Average 45-55 = Average 30-44 = Below Average (Low scores are good)"|Randomization, Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)||||T-score on a scale||Standard Deviation|Mean
1219680|NCT00736255|Secondary|Continuous Performance Test (CPT) Reaction Time Standard Error|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors – measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)||||Reaction time in seconds||Standard Deviation|Mean
1219681|NCT00736255|Secondary|Continuous Performance Test (CPT) Commission Errors|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors – measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)||||Errors of Commission||Standard Deviation|Mean
1219682|NCT00736255|Secondary|Smoking Rates|Smoking rates, measured as self-reported cigarettes/day.|Randomization, visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)||||Cigarettes smoked per day||Standard Error|Mean
1219683|NCT00736255|Primary|The Number of Subjects in Each Treatment Group Exhibiting Sustained, 4-week Smoking Abstinence, Defined as CO Levels <= 4 Ppm for Each Post-quit Study Visit.|The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels <= 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.|4 weeks|Subjects exhibiting sustained 4 week smoking abstinence defined as CO levels <= 4ppm for each post quit study visit were analyzed for the outcome measure.|||participants|||Number
1219717|NCT00736099|Secondary|Change in FPG From Baseline to Week 78||Baseline and week 78|Treated Set with values for FPG at baseline and at week 78. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1219718|NCT00736099|Secondary|Change in FPG From Baseline to Week 66||Baseline and week 66|Treated Set with values for FPG at baseline and at week 66. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1219684|NCT00736242|Secondary|Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment|"An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a~congenital anomaly or birth defect."|From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).|Safety Analysis Set: All participants who received any amount of PEG-IFN alfa-2b. If the application of any PEG-IFN alfa-2b was not certain, the participant was considered part of this set. Participants who were not treated with PEG-IFN alfa-2b were also included in this set providing they did not violate any inclusion or exclusion criterion.|||participants|||Number
1219685|NCT00736242|Secondary|Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment|The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.|From the Baseline Visit up to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with data available.|||cells/μL||Full Range|Median
1219686|NCT00736242|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment.~HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing"|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.|||participants|||Number
1219687|NCT00736242|Secondary|Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR).~HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing."|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.|||participants|||Number
1219688|NCT00736242|Secondary|Participant Study Status at End of Follow-up (EOF)|"Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA.~SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT."|From EOT to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, with HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.|||participants|||Number
1219689|NCT00736242|Secondary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as undetectable serum HCV-RNA at week 12 and/or a~≥2 log decline in HCV-RNA levels at week 12 from baseline."|From Treatment Week 1 to Treatment Week 12|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 12.|||participants|||Number
1219690|NCT00736242|Secondary|Number of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable serum HCV-RNA at week 4.|At Treatment Week 4|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 4|||participants|||Number
1219691|NCT00736242|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).|From End of Treatment to 24 weeks post-treatment (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for ≥6 months before the first application of PEG-IFN alfa-2b, Human Immunodeficiency Virus [HIV] co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.|||participants|||Number
1219692|NCT00736229|Secondary|Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)||30 days||||participants|||Number
1219693|NCT00736229|Secondary|Rates of Hypoglycemia and Severe Hypoglycemia|Total number of patients having at least one hypoglycemic episode (blood glucose less than 70 mg/dl), including episodes classified as severe (blood glucose less than 50 mg/dl)|1-48 hours||||participants|||Number
1219694|NCT00736229|Primary|Time to Steady State|Time to steady state was defined as the time from the initiation of drug infusion (Exenatide or Insulin) to first glucose value that is ≤140 mg/dl.|Start of infusion through 48 hours or until discharge||||hours||Inter-Quartile Range|Median
1219695|NCT00736229|Primary|Median Glucose Values From Steady State Through 48 Hours or Until Discharge.|Time to steady state was defined as the time from the initiation of drug infusion to first glucose value that is ≤140 mg/dl. Median glucose values were then calculated for each patient from the start of steady state through 48 hours or until discharge.|1-48 hours|Intention to treat|||mg/dL||Inter-Quartile Range|Median
1219696|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Who Discontinued the Study Early|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, discontinued TDF treatment after Week 24 with HBV DNA >= 400 copies/mL, and had serum sample for testing.|||Participants|||Number
1219697|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants With Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and had virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).|||Participants|||Number
1219698|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Without Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|10 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and did not have virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).|||Participants|||Number
1219699|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||2099-01-31|01/2099||||
1219700|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||2099-01-31|01/2099||||
1219701|NCT00736190|Secondary|Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48|Blood samples from study participants were collected for measuring HBV DNA via PCR method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1219702|NCT00736190|Secondary|Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion|HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48.|Week 48||||Participants|||Number
1219703|NCT00736190|Secondary|Change From Baseline in FibroTest Value|The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant’s age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline and Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Scores on a scale||Standard Deviation|Mean
1219704|NCT00736190|Secondary|Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48|Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1219705|NCT00736190|Secondary|Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48|A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L)|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study, received at least one dose of study drug, and had baseline ALT > ULN (34 U/L).|||participants|||Number
1219706|NCT00736190|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48|Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1219707|NCT00736190|Primary|Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)|Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1219708|NCT00736125|Secondary|Biomarkers of Neuronal Damage||Within 72 hours after surgery|||||||
1219709|NCT00736125|Secondary|Systemic Inflammatory Response (SIRS) Markers||Within 72 hours after surgery|||||||
1219710|NCT00736125|Secondary|Cardiac Injury||Within 3 days after surgery|||||||
1219711|NCT00736125|Secondary|Changes in Pulmonary and Renal Function||Within 3 days after surgery|||||||
1219712|NCT00736125|Secondary|Delirium During Hospital Stay||First 3 days after surgery|||||||
1219713|NCT00736125|Secondary|Changes in Neurocognitive Tests Following Surgery||2 weeks prior to 1 year following surgery|||||||
1219714|NCT00736125|Secondary|Number of Patients With Emboli in the High Category||During surgery||||Patients w/ emboli in high category|||Number
1219715|NCT00736125|Primary|The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)||During surgery||||emboli|||Number
1219719|NCT00736099|Secondary|Change in FPG From Baseline to Week 54||Baseline and week 54|Treated Set with values for FPG at baseline and at week 54. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1219734|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for LDH|||participants|||Number
1219735|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Albumin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.|78 weeks|Treated Set with values for Albumin|||participants|||Number
1219736|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.|78 weeks|Treated Set with values for AP|||participants|||Number
1219737|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.|78 weeks|Treated Set with values for Bilirubin|||participants|||Number
1219738|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Glucose|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.|78 weeks|Treated Set with values for Glucose|||participants|||Number
1219739|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for AST|||participants|||Number
1219740|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for ALT|||participants|||Number
1219741|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Sodium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).|78 weeks|Treated Set with values for Sodium|||participants|||Number
1219742|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Calcium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).|78 weeks|Treated Set with values for Calcium|||participants|||Number
1219743|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Phosphate|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).|78 weeks|Treated Set with values for Phosphate|||participants|||Number
1219744|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for Creatinine kinase|||participants|||Number
1219745|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.|78 weeks|Treated Set with values for Creatinine|||Participants|||Number
1219746|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for GGT|||Participants|||Number
1219747|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Amylase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).|78 weeks|Treated Set with values for Amylase|||Participants|||Number
1219748|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Triglycerides|||Participants|||Number
1219749|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.|78 weeks|Treated Set with values for Uric acid|||Participants|||Number
1219750|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Potassium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).|78 weeks|Treated Set with values for Potassium|||participants|||Number
1219751|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Platelets|For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).|78 weeks|Treated Set with values for Platelets|||Participants|||Number
1219752|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: White Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).|78 weeks|Treated Set with values for White blood cell count|||Participants|||Number
1219753|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Red Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.|78 weeks|Treated Set with values for Red blood cell count|||Participants|||Number
1219754|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haematocrit|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.|78 weeks|Treated Set with values for Haematocrit|||Participants|||Number
1219755|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haemoglobin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.|78 weeks|Treated Set with values for Haemoglobin|||Participants|||Number
1219757|NCT00736099|Primary|Number of Patients With Abnormalities in Vital Signs|Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
1219758|NCT00736099|Primary|Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events|Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)|78 weeks|Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug|||participants|||Number
1219759|NCT00736099|Primary|Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)|As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
1219760|NCT00736099|Primary|Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events||78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
1219761|NCT00736099|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
1219762|NCT00736073|Secondary|Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis||7 days||||participants|||Number
1219763|NCT00736073|Secondary|Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis||48 hours post ERCP and 1 week post ERCP|There are 2 telephone assessments that participants are required to complete in order to analyze the outcome measure. The study team was unable to collect both assessments within the required timeframe due missed calls & lack of return calls from participants. Therefore data collection and analysis could not be completed per protocol.||||||
1219764|NCT00736073|Primary|Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).||48 hours|The number of participants who received the aprepitant or placebo were evaluated for ERCP pancreatitis. Each case of ERCP pancreatitis was tracked for the participant.|||cases of ERCP in participants|||Number
1219765|NCT00736034|Secondary|Clinical Global Impression of Change (CGI-C)Scale|The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician’s global impression of change. Global improvement score ranges from 1 = “Very much improved”, through 4 = “No change”, to 7 = “Very much worse”. Participants who experienced an improvement (scores 1, 2 or 3) were classified as improved over the treatment period.|15 weeks|||||||
1219766|NCT00736034|Primary|Change From Baseline in Neuropsychological Computerized Test|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|baseline, 15 weeks||||Points on a scale||Standard Deviation|Mean
1219767|NCT00735969|Primary|Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.||24 weeks after treatment stop||||participants|||Number
1219768|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1219769|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1219770|NCT00735943|Secondary|Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy|VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient’s VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1219771|NCT00735943|Secondary|Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen|Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1219772|NCT00735943|Secondary|Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA|FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1219773|NCT00735943|Secondary|Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||injections||Full Range|Median
1219774|NCT00735943|Secondary|Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||injections|||Number
1219775|NCT00735943|Secondary|Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA|Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1219776|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters|A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions.|12 months or last follow-up visit before study termination|Due to small sample size, the analysis was not conducted.|||Percentage of participants|||Number
1219777|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique.|||Percentage of participants|||Number
1219778|NCT00735943|Secondary|Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy|Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF analysis.|||Percentage of participants|||Number
1219779|NCT00735943|Primary|Median Number of Injections to Achieve Stabilization of VA|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.|||injections||Full Range|Median
1219780|NCT00735943|Primary|Average Number of Injections to Achieve Stabilization of VA|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.|||injections||Standard Deviation|Mean
1219793|NCT00735878|Primary|The Median Survival in the Study Population|Median overall survival using the Kaplan Meier method|from the start of the study until the last subject dies (up to 100 weeks)|12 Participants were enrolled into the phase 1 portion of the tiral and later 8 more patients were enrolled for a total of 20 analyzed patients.|||months||95% Confidence Interval|Median
1223630|NCT00711009|Secondary|Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1219781|NCT00735943|Primary|Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)|VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.|Baseline through 12 months or last follow-up visit before study termination|Full Analysis Set (FAS) included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by Last Observation Carried Forward (LOCF) technique.|||percentage of participants|||Number
1219782|NCT00735917|Secondary|Progression-Free Survival|Time from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.|Progression and survival status assessed every month, up to 2 years||||months||95% Confidence Interval|Median
1219783|NCT00735917|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Estimated by the method of Kaplan-Meier.|From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years|No patients qualified for a confirmed response and therefore this endpoint was not analyzed.||||||
1219784|NCT00735917|Secondary|Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])|"A confirmed tumor response is defined to be a CR or PR noted as > the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) > > Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to <1.0 centimeters. >~> Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters."|Evaluated using the first 6 courses of treatment||||participants|||Number
1219785|NCT00735917|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.|Up to 2 years||||months||95% Confidence Interval|Median
1219786|NCT00735917|Primary|Six Month Survival|The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.|Up to 6 months||||percentage of patients||95% Confidence Interval|Number
1219787|NCT00735904|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).|||Months||95% Confidence Interval|Median
1219788|NCT00735904|Secondary|Progression Free Survival (PFS)|"Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
1219789|NCT00735904|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
1219790|NCT00735904|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1219791|NCT00735878|Secondary|Number of Patients With Buccal Cells Demonstrating a Decline in Cyclin D1|Cyclin D1 levels were evaluated by immunoblot analyses of pretreatment (day 0) and paired posttreatment (day 4, 8 and 22) buccal swabs.|pretreatment (Day 0) and patient paired post- treatment (Days 4,8, 22) buccal swabs.|A subset of patients treated at the recommended Phase II dose from Phase II/Group 2|||participants|||Number
1219792|NCT00735878|Secondary|Pharmacokinetic Profile of ABT-751 for Phase 2|The pharmacokinetic profile of ABT-751 given in combination with carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.|Randomization to maximum tolerated dose confirmed|Data were not collected. The PK analysis was not performed at the request of financial sponsor.||||||
1219868|NCT00735475|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|Abbreviation UAE stands for Unsolicited Adverse Event.|21 days after vaccination||||participants|||Number
1219794|NCT00735878|Primary|Objective Response Rate of Participants Using A Combination of ABT-751 and Carboplatin|The effectiveness of the combination with ABT-751 and carboplatin in patients with advanced NSCLC as measured by objective response rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), The disappearance of all known disease determined by two observations not less than four weeks apart.; Partial Response (PR), At least a 30% or more decrease in total tumor load of the lesions that have been measured to determine the effect of therapy by two observations not less than four weeks apart.; Overall Response (OR) = CR + PR|42 days (end of cycle 2)||||Participants|||Count of Participants
1219795|NCT00735878|Primary|Maximum Tolerated Dose (MTD) of ABT-751 in Combination With Carboplatin|The maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose Carboplatin AUC 6 in patients with advanced non small cell lung cancer (NSCLC). Initially, 1 patient will be enrolled in dose level 1. If the patient experiences a Gr 2 toxicity, additional 2 patients will be enrolled at the dose level. If 1 of the 3 patients experience a Gr 3 toxicity or higher the cohort will be expanded to 6 patients. However, if 1 patient completes one cycle at the assigned dose regimen without a Gr 2 toxicity, enrollment in the next cohort (dose level 2) can begin. The rapid dose escalation scheme will apply to cohorts 1 through 3.|21 Days (end of cycle 1)||||mg of ABT-751|||Number
1219796|NCT00735839|Primary|Number of Participants With Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.|Baseline (Day 1) to Day 84 postvaccination||||Participants|||Number
1219797|NCT00735839|Primary|Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level|Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.|Baseline (Day 1) to Day 14 postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1219798|NCT00735826|Secondary|Effects of Vorinostat Treatment on Induction of Apoptosis or Necrosis in Treated vs. Untreated Tumors|vorinostat's effects on induction of apoptosis or necrosis in treated vs untreated tumors and on p21, p27, EGFR, and phospho-EGFR expression aerodigestive tract tumors. Immunohistochemical score is defined as follows: 0, no tumor cells staining positive; 1+, 0% to 50% of tumor cells staining positive; 2+, 50% to 75% of tumor cells staining positive; and 3+, 75% to 100% of tumor cells staining positive.|Baseline to day 7||||score on a scale||95% Confidence Interval|Mean
1219799|NCT00735826|Secondary|Concentration of Vorinostat in Tumor Tissue|Concentration of vorinostat in tumor tissue will be measured after 7 days of use of Vorinostat.|Day 7 from Baseline||||ng/mg||95% Confidence Interval|Median
1219800|NCT00735826|Primary|Changes in Tumor Markers on Tumors of the Lung, Esophagus, or Head and Neck, After 7 Days of Treatment With Vorinostat|Immunohistochemical score, defined as: 0, no tumor cells staining positive; 1+, 0% to 50% of tumor cells staining positive; 2+, 50% to 75% of tumor cells staining positive; and 3+, 75% to 100% of tumor cells staining positive. The change in the score before and after treatment is percentage - 0-100|Baseline to Day 7|Participants who had at least two days days of treatment with vorinostat.|||percentage of change||95% Confidence Interval|Median
1219801|NCT00735787|Secondary|Number of Subjects With Difficulties According to PHQ-9|Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).|Baseline and Weeks 2, 8, 16, and 28|"Analysis was based on the ITT subject population. Missing values were imputed as extremely difficult."|||subjects|||Number
1219802|NCT00735787|Secondary|Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)|The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
1219803|NCT00735787|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)|WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).|Baseline and Weeks 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
1219804|NCT00735787|Secondary|Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain|On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using LOCF.|||mm on scale||Standard Deviation|Mean
1219805|NCT00735787|Secondary|Number of Subjects Achieving a DLQI of 0|Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1219806|NCT00735787|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
1219807|NCT00735787|Secondary|Number of Subjects With PASI 100|Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1219869|NCT00735475|Secondary|Duration of Local and Systemic Solicited Symptoms||5 days after vaccination||||Days||Standard Deviation|Mean
1219808|NCT00735787|Secondary|Number of Subjects With PASI 90|Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1219809|NCT00735787|Secondary|Number of Subjects With PASI 75|Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1219810|NCT00735787|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50|Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1219811|NCT00735787|Secondary|Number of Subjects With PGA of Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1219812|NCT00735787|Secondary|Number of Subjects With PGA of Clear or Almost Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
1219813|NCT00735787|Secondary|Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
1219814|NCT00735787|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).|Baseline and Weeks 8, 16, and 28|Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF.|||units on a scale||Standard Deviation|Mean
1219815|NCT00735787|Secondary|Number of Subjects With Marked Improvement in ESIF From Baseline|Number of subjects that achieved > 75% reduction from Baseline in ESIF|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
1219816|NCT00735787|Secondary|Number of Subjects With Moderate Improvement in ESIF From Baseline|Number of subjects that achieved > 50% reduction from Baseline in ESIF.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
1219817|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Soles|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using the LOCF method.|||units on a scale||Standard Deviation|Mean
1219818|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Palms|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using the LOCF method.|||units on a scale||Standard Deviation|Mean
1219819|NCT00735787|Secondary|Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1219820|NCT00735787|Primary|Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Week 16|Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders.|||subjects|||Number
1219821|NCT00735709|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants' absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
1219822|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219823|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219824|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2 and 4|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219825|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219826|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219827|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219828|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219829|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219870|NCT00735475|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms||5 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||Percentage of Participants|||Number
1219830|NCT00735709|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis|Baseline and Weeks 1, 4, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219831|NCT00735709|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219832|NCT00735709|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219833|NCT00735709|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219834|NCT00735709|Secondary|Percentage of Participants With a Sustained Response in HAM-D24 Total Score|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|From Baseline through Week 8|Full analysis set|||percentage of participants|||Number
1219835|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Other Weeks Assessed|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Weeks 1, 2, 4 and 6|Full analysis set with available data at Week 1; Last observation carried forward was used for other time points.|||percentage of participants|||Number
1219836|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥20 and with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219837|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Week 1; Last observation carried forward (LOCF) was used for other time points. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1219838|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available CGI-S data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219839|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2 and 6|"Full analysis set with available SDS Total Score data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219840|NCT00735709|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1219841|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
1219842|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1219843|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Week 8|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Week 8|Full analysis set; last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1219844|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1219845|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1219871|NCT00735475|Primary|Percentage of Participants With Seroconversion 21 Days After the Study Vaccination|Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.|||Percentage of participants||95% Confidence Interval|Number
1219846|NCT00735709|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8|The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|The full analysis set (FAS) included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1219847|NCT00735696|Secondary|Maximum Concentration of Ramucirumab (Cmax)||Week 18 (Cycle 6), at 1-Hour Post End of Infusion|Participants who received any quantity of study medication and had evaluable concentration data at the specified time point.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
1219848|NCT00735696|Secondary|Serum Anti-Ramucirumab Antibody Assessment|The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline.|Week 15 (Cycle 5)|Participants who had Anti-Ramucirumab Antibody assessment at week 15 (cycle 5).|||participants|||Number
1219849|NCT00735696|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive.|First dose to death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Fourteen participants were censored."|||months||95% Confidence Interval|Median
1219850|NCT00735696|Secondary|Progression-free Survival (PFS)|"Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause.~Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy."|First dose to measured progressive disease or death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored."|||months||95% Confidence Interval|Median
1219851|NCT00735696|Secondary|Overall Survival (OS) at 1 Year|Data presented are the percentage of participants surviving at least 12 months after first dose of study medication.|First dose to 1 year|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1219852|NCT00735696|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.|First dose up to 32.5 months|Participants who had tumor response. Two participants who had tumor response did not progress by the data cut-off date, therefore were censored for duration of response analysis.|||months||95% Confidence Interval|Median
1219853|NCT00735696|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])|Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.|First dose to measured progressive disease or death due to any cause up to 32.5 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1219854|NCT00735696|Secondary|Summary of Participants Reporting Adverse Events|Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Baseline up to 32.5 months|Safety Population: All participants who received any quantity of study drug.|||participants|||Number
1219855|NCT00735696|Primary|Percentage of Participants Who Are Progression-free (PFS) at 6 Months|Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.|6 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored."|||percentage of participants||95% Confidence Interval|Number
1219872|NCT00735475|Primary|Geometric Mean Titer 21 Days After the Study Vaccination||21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.|||Titers||95% Confidence Interval|Geometric Mean
1219906|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 8 of treatment|5 subjects with missing values|||mm (on a scale)||Standard Deviation|Mean
1223631|NCT00711009|Secondary|Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1219856|NCT00735670|Secondary|Depression Scale of the Patient Health Questionnaire (PHQ-9)|The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Higher total scores indicate more severe symptomatology, ranging from 0 (no symptoms) to 27 (most severe symptoms). Data in the tables begin with the overall mean for each group that includes all subjects, average across all assessment time points. Each subsequent row reports the mean and standard deviation of each time point by allocation, noting sample size for each group in the arm/group title given missing data in each time point after baseline.|Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks|Subjects with PHQ-9 data at any of the measurement time points (baseline, weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks) are included in the means reported for each time point. The sample size for each time point is given in the category title (e.g., 10Ven = 10 venlafaxine group or 11Plac = 11 placebo group) if it deviates from baseline.|||units on a scale||Standard Deviation|Mean
1219857|NCT00735670|Primary|16-Item Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR16)|The QIDS assesses symptoms of depression across the nine DSM-IV criterion domains for major depressive episode. The primary end-point in this study was the number of participants who had a >50% change in scores on the QIDs from baseline to week 13 (end of treatment period).|Baseline and Week 13|Participants who completed the week 13 assessment.|||participants|||Number
1219858|NCT00735644|Other Pre-specified|Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.|Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set.|||Participants|||Number
1219859|NCT00735644|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.|Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.|||Participants|||Number
1219860|NCT00735644|Secondary|Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine|Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the Per Protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1219861|NCT00735644|Secondary|Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Participants|||Number
1219862|NCT00735644|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV|Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1219863|NCT00735644|Primary|Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Participants|||Number
1219864|NCT00735618|Primary|Differences Between Pre/Post ESAS Score|Total symptom burden as measured by Edmonton Symptom Assessment Scale (ESAS) in which there are eight visual analog scales (VAS) of 0 to 10, with 10 being most severe. The differences from ESAS baseline (before) to post (after) a 15 minute, one-time, guided relaxation program for each participant assessed, with the average difference in ESAS scores for all participants reported.|Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)|Analysis included all study participants.|||units on a scale||Standard Deviation|Mean
1219865|NCT00735553|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated||||||
1219866|NCT00735475|Secondary|New Onsets of Chronic Illness|A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||participants|||Number
1219867|NCT00735475|Secondary|Serious Adverse Events||180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||participants|||Number
1219873|NCT00735462|Secondary|Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period|"Treatment related defined as probably related or related by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.~Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction."|Up to 16 weeks|Analysis population was based on safety population which defined as for all subjects randomized and received at lease one dose. There was one subject who randomized to the 2.5% group but received one treatment kit of 3.75% imiq cream, so this subject was assigned to 3.75% for the safety analysis.|||participants|||Number
1219874|NCT00735462|Primary|Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.|The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.|Up to 16 weeks||||proportion of participants||95% Confidence Interval|Number
1219875|NCT00735449|Secondary|Number of Subjects With Adverse Events|Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).|Week 12|Safety population, which included all patients who started the study (randomized) and were treated.|||Participants|||Number
1219876|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 6|Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1219877|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 12|Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1219878|NCT00735449|Primary|Mean Intraocular Pressure (IOP) at 10 AM at Week 12|Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1219879|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 10 AM at Week 6|Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1219880|NCT00735436|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities|47 months|intent-to-treat|||participants|||Number
1219881|NCT00735436|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage|Incidence and severity of CNS hemorrhage|47 months|intent-to-treat|||participants|||Number
1219882|NCT00735436|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause, assessed up to 47 months|intent-to-treat|||months||95% Confidence Interval|Median
1219883|NCT00735436|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 47 months|intent-to-treat|||months||95% Confidence Interval|Median
1219884|NCT00735436|Secondary|24-week Progression-free Survival (PFS)|The percentage of participants surviving 24 weeks from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|24 weeks|intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1219885|NCT00735436|Primary|24-week Overall Survival|The percentage of participants surviving 24 weeks from the start of study treatment|24 weeks|intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1219886|NCT00735397|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline(responders) was assessed. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.|||Percent responders|||Number
1219904|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 4 of treatment|5 subjects with missing values|||participants|||Number
1219905|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 12 of treatment|Intention to treat population|||mm (on a scale)||Standard Deviation|Mean
1219887|NCT00735397|Secondary|Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.|||Percent change||Full Range|Median
1219888|NCT00735397|Primary|Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.|The safety analysis set (SAS) was defined as participants who provided informed consent for the OLE study, received at least 1 dose of perampanel in the OLE study, and had at least 1 postdose safety assessment in the OLE study.|||participants|||Number
1219889|NCT00735371|Secondary|Youth Quality of Life-Research Version (YQOL-R) Total Score|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 4 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1219890|NCT00735371|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|1, 2, 3 and 4 Weeks|FAS|||Participants|||Number
1219891|NCT00735371|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3 and 4 weeks|Full Analysis Set (FAS) is defined as all subjects who took at least one dose of study medication and had a valid Baseline and at least one post-Baseline follow-up assessment of the primary outcome measure (ADHD-RS-IV Total Score)|||Units on a scale||Standard Error|Least Squares Mean
1219892|NCT00735306|Secondary|One Year Overall Survival From Time of Diagnosis|One year survival from time of diagnosis for patients who completed this regimen|1 year||||participants|||Number
1219893|NCT00735306|Secondary|Number of Dose Limiting Toxicities||Within 30 days of completing radiation||||Events|||Number
1219894|NCT00735306|Primary|Tarceva Maximum Tolerated Dose in mg|Tarceva maximum tolerated dose in mg|1 yr||||mg|||Number
1219895|NCT00735254|Primary|Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar|The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision.|1 year|study was not conducted per protocol, data was not collected, study terminated. Reported to IRB and closed study.||||||
1219896|NCT00735072|Primary|Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells)||Week 24||||%CD38+ HLA-DR+ CD8+ T cells||Inter-Quartile Range|Median
1219897|NCT00735072|Secondary|Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only)||Week 24|||||||
1219898|NCT00735072|Secondary|Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only)||Week 24|||||||
1219899|NCT00735072|Secondary|Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay)||Week 24|||||||
1219900|NCT00735072|Secondary|Change in CD4+ T Cell Count||Week 24|||||||
1219901|NCT00735007|Secondary|The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.|Information on these outcomes is shown separately above, apart from information on the incidence of injection site related adverse events which is shown in the Adverse Events section|at the end of weeks 4, 8, and 12 of treatment|||||||
1219902|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 12 of treatment|Intention to treat population|||participants|||Number
1219903|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 8 of treatment|5 subjects with missing values|||participants|||Number
1219907|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 4 of treatment|4 subjects with missing values|||mm (on a scale)||Standard Deviation|Mean
1219908|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 12 of treatment|21 subjects with missing values|||participants|||Number
1219909|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 8 of treatment|21 subjects with missing values|||participants|||Number
1219910|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 4 of treatment|21 subjects with missing values|||participants|||Number
1219911|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219912|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 8 of treatment|5 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219913|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219914|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219915|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219916|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219917|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219918|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219919|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219920|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219921|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219922|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1219947|NCT00734903|Secondary|Addiction Severity Index Employment Composite|Employment problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1219923|NCT00735007|Primary|The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).|"RebiSmart was evaluated as very suitable or suitable; a little suitable; or not suitable at all for self-injecting RNF. The Patient User Trial Questionnaire (UTQ) provides confidence in the ability to evaluate the suitability of the device and ease of understanding the different features of the RebiSmart during the training session and the overall subject impression of the injection administration. Subjects completed the Patient UTQ at Study Day1, Week4, and Week12. The Trainer User UTQ provides confidence in the ability to evaluate the suitability of the RebiSmart by the trainer."|End of 12 week treatment period|4 subjects with missing values|||participants|||Number
1219924|NCT00734994|Primary|Safety and Tolerability|Number of patient treatments stopped due to safety concerns or treatment intolerability. All events below are grade 1/2 toxicity. No grade 3-5 toxicity was observed.|During Treatment Phase average 6 weeks||||Grade 1/2 event count (no grade 3+)|Participants||Number
1219925|NCT00734994|Secondary|Median Recurrence Free-survival|Time to first recurrence of cancer in the bladder.|Median follow-up 3.18 years|Entire cohort|||Months||95% Confidence Interval|Median
1219926|NCT00734968|Primary|Incidence of Post-operative UTI in Treatment Group|The incidence of UTI in the nitrofurantoin group was 17.6%.|6 weeks||||participants|||Number
1219927|NCT00734968|Primary|Incidence of Post-operative UTI in Placebo Group|The incidence of UTI in the placebo group was 32%.|6 weeks||||participants|||Number
1219928|NCT00734968|Primary|Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence|The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)|6 weeks||||participants|||Number
1219929|NCT00734929|Secondary|"Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied"|Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)|48 hour||||participants|||Number
1219930|NCT00734929|Secondary|Time to First Vomiting||48 h|The analysis population only includes participants who had vomiting and had a complete data set|||hours||Inter-Quartile Range|Median
1219931|NCT00734929|Secondary|Number of Vomiting Episodes||48 hours||||vomiting episodes||Inter-Quartile Range|Mean
1219932|NCT00734929|Secondary|Average Nausea Score|Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable|Post OP hours 0-2, 24 h, 48 h||||units on a scale||Inter-Quartile Range|Mean
1219933|NCT00734929|Secondary|Number of Participants With a Complete Response Rate|complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.|24 hours Post OP, 48 hours Post OP||||participants|||Number
1219934|NCT00734929|Secondary|Use of Rescue Antiemetics (48 Hours)||48 hour||||participants|||Number
1219935|NCT00734929|Secondary|Use of Rescue Antiemetics (24 Hours)||24 h||||participants|||Number
1219936|NCT00734929|Secondary|Use of Rescue Antiemetics (Post OP)||Post OP (0 - 2 hours)||||participants|||Number
1219937|NCT00734929|Secondary|Incidence of Vomiting (24 Hours)|Any vomiting or retching|24 h|ITT analysis|||participants|||Number
1219938|NCT00734929|Secondary|Incidence of Vomiting (Post OP)||Post OP (0 - 2 hours)||||participants|||Number
1219939|NCT00734929|Secondary|Incidence of Nausea|operative procedure|Post operative procedure (OP) hours (0-2, 24, 48)||||participants|||Number
1219940|NCT00734929|Primary|Cumulative Incidence of Emesis|Any vomiting or retching|48 h|ITT analysis|||participants|||Number
1219941|NCT00734903|Secondary|Alcoholics Anonymous (AA) Intention Measure|Self-reported attitudes toward attending 12-step meetings; a scale of 17 items, each rated 1 (extremely unlikely) to 7 (extremely likely). The mean across all items thus ranges from 1 to 7 with with more positive scores indicating a more positive attitude toward 12-step meetings.|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1219942|NCT00734903|Secondary|Coping Skills Measure|Self-report measure of confidence in ability to cope comprising 18 items, each scaled from 0 (not at all) to 5 (extremely). The mean across all 18 items ranges from 0 to 5 with higher scores indicating less pathology (i.e., stronger ability to cope).|Baseline, end of treatment, 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1219943|NCT00734903|Secondary|BASIS-24 Psychosocial Functioning|24 items that address how patients feel before and after receiving care. The survey measures the degree of difficulty experienced by the patient during a one-week period on a five-point scale ranging from 0 (no difficulty) to extreme difficulty (4) with the overall score ranging from 0-96.|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1219944|NCT00734903|Secondary|Global Severity Index of the Brief Symptom Inventory|Self-report measure of severity of general psychiatric symptoms ranging from 0 (not at all) to 4 (extremely). The total scale score Global severity index (GSI) is the mean of all 53 items on the measures. The mean ranges from 0 to 4, with higher indicating worse pathology.|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1219945|NCT00734903|Secondary|Addiction Severity Index Family/Social Composite|Family/social problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1219946|NCT00734903|Secondary|Addiction Severity Index Psychiatric Composite|Psychiatric problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1240304|NCT00579670|Secondary|"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?"||Week 12|FAS|||Participants|||Number
1219948|NCT00734903|Secondary|Addiction Severity Index Medical Composite Score|Medical problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1219949|NCT00734903|Primary|Brief Addiction Monitor|Assesses number of days in the past 30 days that person used substances including alcohol and drugs|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||days out of past 30 days||Standard Deviation|Mean
1219950|NCT00734903|Primary|Addiction Severity Index Drug Composite|Drug use and associated problems as measured by blinded-interviewer rated composite score. Urinalysis/breathalyzer is also obtained to verify self-report.Drug use and associated problems as measured by blinded-interviewer rated composite score. Eleven questions comprise the drug composite, of which 9 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome). Urinanalysis was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).|Baseline, end of treatment (3 months), and 3-month post-treatment followup||||units on a scale||Standard Deviation|Mean
1219951|NCT00734903|Primary|Addiction Severity Index Alcohol Composite|Alcohol use and associated problems as measured by blinded-interviewer rated composite score. Six questions comprise the alcohol composite, of which 4 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome). Breathalyzer was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
1219952|NCT00734851|Secondary|Comparison of RNA Expression Profile From Original Prostate Radical Prostatectomy Specimen Among Those With PSA Relapse at 2 and 3 Years as Compared to Those Without PSA Relapse at the Primary Endpoint.|Prospective collection of prostate tissue at the time of radical prostatectomy is routinely performed at Duke. These samples will be analyzed by laser capture microdissection (LCM) for genomic profiling by RNA expression analysis for all subjects with tissue available. The expression profiles of subjects who experience PSA recurrence after protocol therapy by the 24 month endpoint will be compared with the expression profiles of subjects without recurrence at this time point as an exploratory measure to predict aggressive prostate cancer and those subjects who are unlikely to benefit from this approach. Baseline prostate tumor biomarkers in the form of RNA expression profiles will be correlated with 2 year PFS in an exploratory analysis. The median bPFS of those with detectable biomarker expression is reported.|2 and 3 years|Due to the unavailability of tissue, this outcome was not performed.||||||
1219953|NCT00734851|Secondary|Change in Quality of Life (QoL) After 3 Month|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline and 3 months after completing radiotherapy. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 3 months|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.|||units on a scale||Full Range|Median
1219954|NCT00734851|Secondary|Change in Quality of Life (QoL) After 1 Year|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline, at 3 months after completing radiotherapy, at 12 months, and at 2 and 3 years of follow-up for a total of 5 possible surveys per patient. Due to a low number of completed surveys at the fourth and fifth time point, the difference between the 12 month time point and baseline is summarized. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 1 year|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.|||units on a scale||Full Range|Median
1219955|NCT00734851|Secondary|Metastasis-free Survival (MFS) Rates at 2 and 3 Years.|MFS is defined as the length of time between the date of start of treatment and the date of evidence of systemic disease on bone scan or cross sectional imaging or death, whichever occurs first.|2 and 3 years|This rate is not estimable as 0 patients had locally recurrent disease before being taken off study for biochemical progression.||||||
1219956|NCT00734851|Secondary|Rate of Local Recurrence at 2 and 3 Years|Local recurrence is defined as men with locally recurrent disease confirmed pathologically within the radiation field, and is estimated at 2 and 3 years.|24 months and 36 months||||percentage of participants|||Number
1219957|NCT00734851|Secondary|Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.|Percentage of participants surviving 24 and 36 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount or a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks. Please note: bPFS is identical to PFS but includes only PSA-based endpoints or death.|24 months and 36 months||||percentage of patients||95% Confidence Interval|Number
1219958|NCT00734851|Primary|The Rate of Progression Free Survival (PFS) at 24 Months|Percentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, or evidence of clinical progression or initiation of systemic therapy for progressive disease.|2 years||||percentage of patients||95% Confidence Interval|Number
1219959|NCT00734799|Secondary|Nightmare Frequency|Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries.|12 weeks after Baseline||||Nightmare frequency per night||Standard Error|Mean
1219960|NCT00734799|Primary|Insomnia Severity|Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period.|12-weeks after Baseline|Intent to treat and completed were both reported. Data on completers reported here.|||ISI Score||Standard Error|Mean
1219961|NCT00734747|Secondary|Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject||6 months|Note: 1 of the 66 participants was not taking proton pump inhibitors (PPIs) at baseline, therefore they were excluded from the analysis of PPI use reduction.|||percentage of subjects||95% Confidence Interval|Number
1219962|NCT00734747|Secondary|Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test|Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure|6 months||||percentage of time pH <4.0||Standard Deviation|Mean
1219963|NCT00734747|Primary|Serious Adverse Events (SAEs)|The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. “Treatment-related” events were conventionally defined as those which occurred in the first 30 days post-procedure. The SAEs presented here include all SAEs from the study, including one that occurred 35 days post-procedure (suicidal behavior). There was an interim review of early Serious Adverse Events (SAEs) after the first 24 patients. Protocol and device changes were then implemented, prior to the final 48 patients. Therefore, the SAEs are presented in two categories consisting of the first 24 patients and the final 48 patients.|6 months||||participants|||Number
1219964|NCT00734747|Primary|Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score|Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire, also known as Velanovich score. The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total. This questionnaire was administered while the subjects were not taking proton pump inhibitor (PPI) medication (i.e. off-PPI). Criterion for success was an improvement >= 50% compared to baseline, at six months post procedure in at least 53% of the subjects (53% is the lower boundary of the 95% confidence interval)|Six months||||percentage of total participants||95% Confidence Interval|Number
1219965|NCT00734734|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0 to 3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.|||Number of participants|||Number
1219966|NCT00734734|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.|||Percentage of participants||95% Confidence Interval|Number
1219967|NCT00734734|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).~The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.|||Ratio||95% Confidence Interval|Geometric Mean
1219981|NCT00734604|Secondary|Number of Participants With at Least One Serious Adverse Event|Serious adverse events are listed in the Reported Adverse Event module.|baseline through 26 weeks (including two washout periods of 1 week each)||||participants|||Number
1219982|NCT00734604|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint|EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219968|NCT00734734|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1219969|NCT00734656|Secondary|Change in Serum 3a-androstanediol Glucuronide|Ratio of serum 3a-androstanediol drawn prior to alcohol administration (2-4 days after medication administration) compared to the baseline level prior to medication dose. The pharmacologic effect of dutasteride was measured by assay of serum 5a-androstan-3a,17b-diol,17-glucuronide (aka 3a-androstanediol glucuronide) as a biochemical measure of 5a-reductase enzyme inhibition. 3a-androstanediol glucuronide is the primary metabolic excretion product of 3a,5a-androstane neuroactive steroids. The|Baseline (pre medication administration) and 2-4 days post-medication (alcohol session)|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||ratio||Standard Error|Mean
1219970|NCT00734656|Primary|BAES Stimulation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES)Simulation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 stimulation related questions regarding effects of alcohol. Total BAES stimulation subscale score 0-70 with higher numbers indicating greater stimulating effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||units on a scale||Standard Error|Mean
1219971|NCT00734656|Primary|BAES Sedation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score 0-70 with higher numbers indicating greater sedative effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||units on a scale||Standard Error|Mean
1219972|NCT00734656|Primary|Breath Alcohol|Breath Alcohol level|40 minutes after beginning drink|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||gr/dL||Standard Error|Mean
1219973|NCT00734630|Secondary|Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)||||mmHG||Standard Deviation|Mean
1219974|NCT00734630|Primary|Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)||||mmHG||Standard Deviation|Mean
1219975|NCT00734617|Primary|Continuous Abstinence From Smoking at Ten Weeks Post-quit|Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.|May 2009||||participants|||Number
1219976|NCT00734604|Secondary|"Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 4 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219977|NCT00734604|Secondary|"Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 3 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219978|NCT00734604|Secondary|"Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 2 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219979|NCT00734604|Secondary|"Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 1 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219980|NCT00734604|Secondary|Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1–8) and Confidence (items 9–14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219983|NCT00734604|Secondary|Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219984|NCT00734604|Secondary|Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219985|NCT00734604|Secondary|Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection||baseline, 8 weeks of each treatment||||proportion of days||Standard Deviation|Mean
1219986|NCT00734604|Secondary|Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219987|NCT00734604|Secondary|Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219988|NCT00734604|Secondary|Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219989|NCT00734604|Secondary|Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219990|NCT00734604|Primary|Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1219991|NCT00734591|Secondary|Rate of Primary Lung Cancer Diagnosis|The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population|||Lung Cancer per 1000 PY||95% Confidence Interval|Number
1219992|NCT00734591|Secondary|Rate of All-cause Mortality|The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population|||Deaths per 1000 PY||95% Confidence Interval|Number
1219993|NCT00734591|Secondary|Rate of Primary Lung Cancer Mortality Among Former Smokers|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Subset of the entire study population who were former smokers.|||Deaths per 1000 PY||95% Confidence Interval|Number
1219994|NCT00734591|Primary|Rate of Primary Lung Cancer Mortality|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population: all randomized participants (retrospective).|||Deaths per 1000 patient years (PY)||95% Confidence Interval|Number
1219995|NCT00734578|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
1219996|NCT00734578|Secondary|Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF|This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1220106|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1219997|NCT00734578|Secondary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1219998|NCT00734578|Secondary|Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and week 8|FAS|||Percent of participants|||Number
1219999|NCT00734578|Secondary|Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1220000|NCT00734578|Secondary|Change From Baseline in Conners’ Global Index – Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1220001|NCT00734578|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
1220002|NCT00734578|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
1220003|NCT00734578|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and weekly up to 8 weeks|Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study.|||Units on a scale||Standard Deviation|Mean
1220004|NCT00734539|Secondary|Intraventricular Hemorrhage|Grade 3 or 4|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220005|NCT00734539|Secondary|Positive Bacterial Infection From a Sterile Site||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220006|NCT00734539|Secondary|Length of Hospitalization||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||days||Inter-Quartile Range|Median
1220007|NCT00734539|Secondary|Retinopathy of Prematurity Requiring Laser Surgery||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220008|NCT00734539|Secondary|Periventricular Leukomalacia||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220009|NCT00734539|Secondary|Patent Ductus Arterious Requiring Surgical Ligation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220010|NCT00734539|Secondary|Chronic Lung Disease||36 weeks corrected gestational age|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220011|NCT00734539|Secondary|Focal Intestinal Perforation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220012|NCT00734539|Secondary|Stage II or Higher Necrotizing Enterocolitis||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220013|NCT00734539|Secondary|Candidiasis|Definite or probable|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220014|NCT00734539|Secondary|Neurodevelopmental Impairment|Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy|18-22 months corrected gestational age|Attended the follow-up visit and had complete data on composite endpoint|||participants|||Number
1220015|NCT00734539|Primary|Death or Candidiasis|"The primary endpoint for the study is death or candidiasis.~Death prior to study day 49.~Candidiasis prior to study day 49~Definite: isolation of Candida from normally sterile body fluid (blood, CSF, urine [obtained via sterile catheterization or suprapubic tap], peritoneal fluid).~Probable:~i. > 5 days of consecutive antifungal therapy~AND both:~ii. Thrombocytopenia <150,000/mm3 iii. Positive Candida culture from nonsterile site (ETS, bag urine)"|study day 49|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1220016|NCT00734500|Secondary|Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.|During and up to 10 days after last dose of study drug.||||participants|||Number
1220017|NCT00734500|Primary|The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Area under the curve at steady state|5 days||||µg*h/mL||Full Range|Median
1220107|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220018|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks|Data on any new cardiovascular (CV) event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.|||participants|||Number
1220019|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Pancreatitis at 104 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.|||participants|||Number
1220020|NCT00734474|Secondary|Antibodies to LY2189265|The number of participants with postbaseline detection of treatment-emergent antidrug LY2189265 antibodies (ADA) is summarized.|Baseline through 104 weeks|All randomized participants in the LY2189265 arms who had evaluable ADA data. If there were no data after the date of randomization, the endpoint was considered missing.|||participants|||Number
1220021|NCT00734474|Secondary|Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve|Pharmacokinetic (PK) parameter estimates from LY2189265 concentration data were obtained using a 2-compartment population PK model with first order absorption. Area under the plasma-concentration curve from 0 to 168 hours, steady state (AUC0-168h, ss) of LY2189265 is summarized.|Baseline through 52 weeks|Randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) who had blood samples collected for PK assessments.|||nanograms times hours per milliliter||Standard Deviation|Mean
1220022|NCT00734474|Secondary|Resource Utilization|The number of visits to the emergency room (ER) is summarized cumulatively.|Baseline through 52 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.|||events|||Number
1220023|NCT00734474|Secondary|Participant-reported Outcomes, EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts. The first part allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale of 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the questionnaire consists of a 100-millimeter visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable EQ-5D data. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Deviation|Mean
1220024|NCT00734474|Secondary|Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)|The Impact of Weight on Quality of Life-Lite (IWQoL-Lite questionnaire) is an obesity-specific, 31-item questionnaire designed to measure the impact of weight on participants’ quality of life. Items are scored on a 5-point numeric rating scale where 5 = “always true” and 1 = “never true”. Items are summed into 6 scales (physical function [11 items], self-esteem [7 items], sexual life [4 items], public distress [5 items], work [4 items], and total score [31 items]) based on the average for the valid responses on that scale multiplied by the number of items on that scale (rounded to the nearest whole integer). Higher scores indicate lower levels of functioning (negative effects). Scores are linearly transformed to a 0 to 100 scale.|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable IWQoL-Lite data. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Deviation|Mean
1220025|NCT00734474|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable ECG data. If there were no data after the date of randomization, the endpoint was considered missing.|||milliseconds (msec)||Standard Error|Least Squares Mean
1220026|NCT00734474|Secondary|Change From Baseline in Blood Pressure|Sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable SBP and DBP data. If there were no data after the date of randomization, the endpoint was considered missing.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1220108|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220109|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220027|NCT00734474|Secondary|Change From Baseline in Pulse Rate|Sitting and standing pulse rate were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable pulse data. If there were no data after the date of randomization, the endpoint was considered missing.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1220028|NCT00734474|Secondary|Change From Baseline in Blood Pressure at Dose Decision Point|Sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at the dose decision point. Change from baseline in DBP was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the time of the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting SBP and DBP data.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1220029|NCT00734474|Secondary|Change From Baseline in Pulse Rate at Dose Decision Point|Sitting pulse rate was measured at the time that the dose decision was made (dose decision point). Change from baseline in pulse rate was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting pulse rate data.|||beats per minute (bpm)||Standard Deviation|Mean
1220030|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Lipid Tests|The number of participants with treatment-emergent abnormal lipid test (cholesterol, high density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], and triglycerides [TG]) results (defined as lipid test abnormalities that first occurred after baseline) is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
1220031|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
1220032|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR) .|Baseline through 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
1220033|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
1220034|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 104 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.|||participants|||Number
1220035|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|All randomized participants in the LY2189265 and active comparator (Sitagliptin) arms.|||participants|||Number
1220036|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||participants|||Number
1220037|NCT00734474|Secondary|Beta Cell Function and Insulin Sensitivity (HOMA2)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-%B and HOMA2-%S were set at 100%. Least squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point and who had evaluable HOMA2 data. If there were no data after the date of randomization, the endpoint was considered missing.|||HOMA2-%||Standard Error|Least Squares Mean
1220038|NCT00734474|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of HE is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||episodes per participant per year||Standard Deviation|Mean
1220039|NCT00734474|Secondary|Incidence of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of participants with self-reported hypoglycemic events is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||participants|||Number
1220040|NCT00734474|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|The percentage of participants achieving HbA1c levels <7.0% and ≤6.5% was analyzed using a logistic regression model and last observation carried forward (LOCF) imputation with baseline, country, and treatment as factors included in the model.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1220041|NCT00734474|Secondary|Waist Circumference Change From Baseline|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable waist circumference data. If there were no data after the date of randomization, the endpoint was considered missing.|||centimeters (cm)||Standard Error|Least Squares Mean
1220042|NCT00734474|Secondary|Durability of Change From Baseline Body Weight|Durability of effect on body weight was assessed by comparing the differences in mean change from baseline in body weight at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline body weight data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable body weight data. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
1220043|NCT00734474|Secondary|Body Weight Change From Baseline|Least squares (LS) means of change from baseline body weight were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable body weight data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
1220044|NCT00734474|Secondary|Change From Baseline in Body Weight at Dose Decision Point|Change from baseline in body weight was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable body weight data.|||kilograms (kg)||Standard Deviation|Mean
1220045|NCT00734474|Secondary|Fasting Insulin Change From Baseline|Least squares (LS) means of change from baseline fasting insulin data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable fasting insulin data. If there were no data after the date of randomization, the endpoint was considered missing.|||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
1220046|NCT00734474|Secondary|Fasting Blood Glucose Change From Baseline|Least squares (LS) means of change from baseline were calculated using mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable fasting plasma glucose data. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1220047|NCT00734474|Secondary|Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Durability of effect on HbA1c was assessed by comparing the differences in mean change from baseline in HbA1c at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline HbA1c data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable HbA1c data. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
1220048|NCT00734474|Secondary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
1220049|NCT00734474|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point|Change from baseline in HbA1c was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable HbA1c data.|||percentage of HbA1c||Standard Deviation|Mean
1220050|NCT00734474|Primary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
1220051|NCT00734409|Secondary|Mean Days on Mechanical Ventilation|The mean number of days that the patients were on mechanical ventilation.|ICU stay- through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||Days||Standard Deviation|Mean
1220052|NCT00734409|Secondary|Unplanned Self-device Removal Events|The number of unplanned self-device removal events that took place during the study period.|ICU stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||Event|||Number
1220053|NCT00734409|Primary|Mean Sedative Use|The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.|Intensive Care Unit (ICU) stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||ml/hour||Standard Deviation|Mean
1220054|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 11 Months|Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|11 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 9 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 9 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220055|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 10 Months|Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1240305|NCT00579670|Secondary|"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"||Week 12|FAS|||Participants|||Number
1220056|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 9 Months|Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|9 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 8 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220057|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 8 Months|Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220058|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 7 Months|Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|7 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220059|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 6 Months|Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220060|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 5 Months|Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|5 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220061|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 4 Months|Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220062|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 3 Months|Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|3 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220063|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 2 Months|Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 1 subject because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1220064|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 1 Months|Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410–1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|1 month after baseline||||cells/mm3||Full Range|Mean
1220065|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 14 Months|The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1220066|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 12 Months|The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1220067|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 10 Months|The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1220068|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 8 Months|The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1220069|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 6 Months|The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1220216|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
1220070|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 4 Months|The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1220071|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 2 Months|The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm|||count per microliter||Full Range|Mean
1220072|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 14 Months|Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1220073|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 12 Months|Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1220074|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 10 Months|Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1220075|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 8 Months|Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1220076|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 6 Months|Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1220077|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 4 Months|Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1220078|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 2 Months|Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1220079|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 14 Months|Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1220411|NCT00732940|Secondary|Median Percent Change From Baseline in Anti-dsDNA at Week 24||Baseline, 24 weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220080|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 12 Months|Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1220081|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 10 Months|Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1220082|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 8 Months|Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1220083|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 6 Months|Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1220084|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 4 Months|Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|4 months post baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1220085|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 2 Months|Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|baseline to 2 months|Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy.|||white blood cells per microliter (mcL).||Full Range|Mean
1220086|NCT00734305|Secondary|To Determine the Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The AUC is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
1220087|NCT00734305|Secondary|To Determine the Pharmacokinetic and Immunogenicity Parameters of MM-121|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).~Immunogenicity data is not available."|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1220088|NCT00734305|Secondary|To Describe the Dose-limiting Toxicity of MM-121 as a Monotherapy|To establish the safety of escalating doses of MM-121 administered as a monotherapy in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 47 weeks||||participants reporting DLTs|||Number
1220140|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks.||||Days per week with symptoms||Standard Deviation|Mean
1220089|NCT00734305|Primary|Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort from cohort 1-6. Cohort 1 began at 3.2 mg/kg IV QW and the dose escalated in separate cohorts from 6 mg/kg IV QW, 10 mg/kg IV QW, 15 mg/kg IV QW, 20 mg/kg IV QW, to the highest scheduled testing dose at 40 mg/kg one-time loading dose on cycle 1, week 1 followed by 20 mg/kg IV QW maintenance doses. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose and was used to open the expansion cohort.|From date of first dose to 30 days after termination, the longest 47 weeks|All participants in the 6 cohorts of dose escalation|||mg/kg|||Number
1220090|NCT00734305|Primary|Objective Response Rate and Duration|"To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response is defined as a >20% decrease in tumor burden from baseline and a Complete Response is defined as complete disappearance of tumor burden from baseline. Duration of response is defined as the length of time in weeks from observation of response until progression.~NOTE: because no patients experienced an objective response as shown below, duration of response is not presented. No duration of response could be measured."|Time from first dose to date of progression, with a median of 7.1 weeks||||participants with objective response|||Number
1220091|NCT00734214|Primary|Hyponatremia|Plasma sodium less than 135 mmol/L|during the study intervention|Intention to treat analysis|||participants|||Number
1220092|NCT00734214|Secondary|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.||During the treatment and follow-up period|||||||
1220093|NCT00734214|Primary|Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)||During the treatment and follow-up period.|||||||
1220094|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-Positive with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
1220095|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
1220096|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
1220097|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
1220098|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
1220099|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
1220100|NCT00734162|Secondary|Number of Participants With Changes in Drug-Resistant Mutations During the Study|The number of participants with changes in drug-resistant mutations during the study was summarized.|Baseline through Week 192|Participants with HBV DNA ≥ 400 copies/mL, with confirmed virologic breakthrough (defined as 2 consecutive increases in HBV DNA of at least 10-fold from nadir, or confirmed values ≥ 400 copies/mL after being < 400 copies/mL while on study medication), or subjects who discontinued early (after Week 24 with HBV DNA ≥ 400 copies/mL) were analyzed.|||participants|||Number
1220101|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220102|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220103|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220104|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220105|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220110|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 48|To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject’s recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject’s recorded value was higher than typical for their age, ethnicity, and gender. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1220111|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220112|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220113|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220114|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220115|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220116|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220117|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220118|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220119|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220120|NCT00734162|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1220121|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 72, 96, 144, and 192|Safety Analysis Set|||percentage of participants|||Number
1220122|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 96, 144, and 192|Safety Analysis Set|||percentage of participants|||Number
1220123|NCT00734162|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192|HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1220124|NCT00734162|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1220125|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1220126|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1220127|NCT00734162|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1220128|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1220180|NCT00733993|Primary|Visual Analog Scale Subjective Rating of Drug Effects|Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.|Immediately after dose||||units on a scale||Standard Error|Mean
1240306|NCT00579670|Secondary|"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?"||Week 12|FAS|||Participants|||Number
1220129|NCT00734162|Primary|Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72|"Data were summarized by treatment and age group (grouped by baseline age for analysis).~In contrast with what was previously reported in the interim results posting, 1 participant met the primary safety endpoint of at least a 6% decrease from baseline in spine BMD at Week 72, based on the final BMD data analysis. The apparent discrepancy was due to the correction factor applied to the subject-specific BMD calculations performed at the time of the Interim Week 72 clinical study report that could not take into account the actual Week 72 phantom data (ie, calibration test used in longitudinal clinical trials to monitor and adjust for shifts in the dual-energy x-ray absorptiometry (DXA) scanner calibration over time), which were not provided by the site at that time. The correction factor applied to the final analysis has been properly based on all phantom data through the end of Week 72, as well as through the end of Week 192."|Baseline to Week 72|Safety Analysis Set: participants who received at least one dose of study drug.|||percentage of participants|||Number
1220130|NCT00734162|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72|"The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm.~In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included."|Week 72|Full Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1220131|NCT00734149|Secondary|Median Duration of Response|Duration of response is measured from date of first confirmed response until date of disease progression.|up to 4 years||||months||95% Confidence Interval|Median
1220132|NCT00734149|Secondary|Number of Patients With Any Grade or Severe Adverse Event|Number of patients with any grade or severe, defined as ≥ grade 3 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0, adverse events as a measure of safety|At any time during the study and up to 30 days after stopping the study drug||||participants|||Number
1220133|NCT00734149|Primary|Response|Overall response rate equals complete response and partial response per Southwest Oncology Group Criteria. Measurable, quantifiable protein criteria must be present. Acceptable protein criteria are quantitative immunoglobulin IgG, IgA, IgD, IgE or IgM and/or urine M-component (Bence-Jones protein). If both are present, the quantitative immunoglobulin will be followed for response. Complete Remission: The absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-components on electrophoresis as by immunofixation studies. There must also be no evidence of increasing anemia. Partial Remission: A 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). Stable/No Remission): A <50% reduction I nthe quantitative immunoglobulin, or if the patient has light-chain disease only, a <50% reduction in the urine M-component (Bence-Jones protein.|6 weeks following completion of treatment||||participants|||Number
1220134|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 4 Weeks of Treatment|"Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units of scale||Standard Deviation|Mean
1220135|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 8 Weeks of Treatment|"Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
1220136|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 4 Weeks of Treatment|"Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units of scale||Standard Deviation|Mean
1220137|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 8 Weeks of Treatment|"Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
1220138|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 8 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe)."|At Baseline and 8 weeks||||Days per week with pain||Standard Deviation|Mean
1220139|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 4 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Days per week with pain||Standard Deviation|Mean
1220536|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|6 months post-surgery||||"% responding yes and probably"|||Number
1220141|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks.||||Days per week with symptoms||Standard Deviation|Mean
1220142|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment|"Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units on scale||Standard Deviation|Mean
1220143|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment|"Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
1220144|NCT00734097|Secondary|Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment|Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.|At Baseline and 4 weeks||||Days per week with symptoms||Standard Deviation|Mean
1220145|NCT00734097|Primary|Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment|Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline|At Baseline and 8 weeks||||Days per week with symptoms||Standard Deviation|Mean
1220146|NCT00734071|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set with available data at Baseline (139 and 136 patients) and at Week 8 (122 and 131 patients).|||participants|||Number
1220147|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220148|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220149|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220150|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220151|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220213|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
1220567|NCT00731874|Secondary|Incidence of Opportunistic Infection||36 months post-transplant||||Participants|||Count of Participants
1220152|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220153|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220154|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220155|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220156|NCT00734071|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220157|NCT00734071|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1220158|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220159|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used; n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1220412|NCT00732940|Secondary|Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24||Baseline, 24 Weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.|||IU/mL||Standard Error|Mean
1220160|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means and P-values were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220161|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220162|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220163|NCT00734071|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220164|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220165|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220166|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.|||percentage of participants|||Number
1220167|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220168|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220169|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220170|NCT00734071|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220171|NCT00734032|Secondary|Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline [Week 1, Week 2 and Follow-up] values) minus log (Baseline value).|Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)|FAS Population with LOCF analysis.|||Log(millimole per milliliter per minute)||Geometric Coefficient of Variation|Geometric Mean
1220172|NCT00734032|Secondary|Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up–Baseline value) divided by [Baseline value]).|Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)|FAS Population with LOCF analysis.|||Percent inhibiton of Lp-PLA2 activity||Standard Deviation|Mean
1220173|NCT00734032|Primary|Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value [week 4]) minus log (Baseline value).|Baseline (Week 0, Visit 2) and Week 4|Full Analysis Set (FAS) Population was defined as all randomized participants who received at least one dose of study medication during treatment period and who had at least one evaluable assessment of Lp-PLA2 activity after randomization. Missing values during treatment period, except for Baseline were imputed by last observed response (LOCF).|||Log(millimole per milliliter per minute)||Geometric Coefficient of Variation|Geometric Mean
1220174|NCT00733993|Secondary|Saliva Caffeine and Paraxanthine Levels|"Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects.~Analyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls."|30 minutes prior to dose, 30/90/150 minutes post dose.|Assessment was not performed for amphetamine intervention|||ng/mL||Standard Error|Mean
1220175|NCT00733993|Secondary|Probabalistic Feedback Selection Task|Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.|75 minutes after dose||||accuracy||Standard Error|Mean
1220176|NCT00733993|Primary|Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects|Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.|Immediately after dose||||units on a scale||Standard Error|Mean
1220177|NCT00733993|Primary|Addiction Research Center Inventory Subjective Rating of Drug Effects|"Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items.~Includes the following subscales:~Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and intellectual efficiacy (+4 to +9, higher scores = more energy)"|Immediately after dose||||units on a scale||Standard Error|Mean
1220178|NCT00733993|Primary|Heart Rate|Sitting heart rate|Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours||||Beats per minute||Standard Error|Mean
1220179|NCT00733993|Primary|Systolic and Diastolic Blood Pressure|Sitting Blood Pressure|Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours||||mmHg||Standard Error|Mean
1220181|NCT00733980|Secondary|Discontinuation-Emergent Signs and Symptoms|The discontinuation signs and symptoms scale consisted of 43 signs and symptoms, scored as ‘new symptom (NS)’, ‘old symptom (OS) but worse’, ‘OS but improved’ or ‘ symptom not present/old symptom but unchanged’. The total number of new signs and symptoms, old symptoms but worse, and old symptoms but improved was calculated for each participant. The number of participants with Discontinuation-Emergent Signs and Symptoms were reported. The visits were at Week 6 Visit, 7-D FU and 28-D FU visit.|At Week 6, 7-day (D) FU and 28-D FU|All subject population.|||Participants|||Count of Participants
1220182|NCT00733980|Secondary|Number of Participants With Hormonal Data of PCI|The number of participants with hormone values outside the CRI were reported. The hormone data was analyzed for parameters like Cortisol total, Dehydroepiandrosterone, Thyroxine, free, and thyroid stimulating hormone (TSH) .|up to Week 10|All subject population.|||Participants|||Count of Participants
1220183|NCT00733980|Secondary|Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range|The number of participants with clinical chemistry values outside the clinical importance range (CIR) were reported. The values for chemistry parameters outside CRI were reported for Alanine amino transferase (ALT), Aspartate amino transferase, total bilirubin, calcium, Creatine Kinase, carbon dioxide (CO^2) content/bicarbonate (BC), glucose and potassium were reported.|Upto Week 10|All subject population.|||Participants|||Count of Participants
1220184|NCT00733980|Secondary|Number of Participants With Abnormal Hematology Values of PCI-Platelet|Number of participants with abnormal Hematology values of PCI were reported. The abnormal values were reported only for platelet, diagnosed at Week 6 or Early withdrawal visit.|Upto 28-day FU|All Subject population|||Participants|||Count of Participants
1220185|NCT00733980|Secondary|Number of Participants With Abnormal Electrocardiograph (ECG) Values|The 12-lead ECG, were obtained at each time-point during the study using an ECG machine. The number of participants with ECG abnormal values were reported.|Randomization (Week 0), Week 4, Week 6 and 28 Day follow-up|All subject population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1220186|NCT00733980|Secondary|Number of Participants With Abnormal Urinalysis Data|Urinalysis included analysis for urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine proteins and urine Leukocyte Esterase test (LET) via dipstick analysis. The number of participants with abnormal urinalysis data were reported. In the dipstick test the levels for urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine proteins and urine LET with results of trace, negative, positive,1+=slightly positive, 2+=positive, 3+=high positive were reported.|Randomization (Week 0), Week 3, Week 6/ Early withdrawal (EW) and 28 Day follow-up (FU)|All subject population.|||Participants|||Count of Participants
1220187|NCT00733980|Secondary|Number of Participants With Vital Sign of Potential Clinical Importance (PCI)|Vital sign measurements included height (screening only), systolic blood pressure(SBP) and diastolic blood pressure (DBP) and heart rate (HR). Sitting vital signs were measured at all clinic visits. Standing vital signs were measured at screening, Week 3 and at any other times as clinically indicated. Only the PCI values for SBP, DBP and HR were reported.|Up to Week 10|All subject population.|||Participants|||Count of Participants
1220188|NCT00733980|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to 28-day FU (18 months)|All subject population.|||Participants|||Count of Participants
1220189|NCT00733980|Secondary|Change From Randomization in the Cohen Perceived Stress Scale (PSS) at Week 6.|The PSS is most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in past month (how unpredictable, uncontrollable, and overloaded respondents find their lives). Individual items were rated on a scale of 0-4, where 0(never) to 4 (very often) that best describes how often they have had the feelings or thoughts described in the last month for each question. The total scores can range from 0-40, where 0 score indicated no stress and a higher score indicated more stress. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0. Thus a negative change from randomization indicated improvement.|Randomization (Week 0) and Week 6.|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1220190|NCT00733980|Secondary|Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6|The MOS-12 Sleep Scale is a 12-item questionnaire which measures specific aspects of sleep in participants that may have varying co-morbidities, as a result, is appropriate for a medically diverse participant population. It consist of following items: initiation (2 items), maintenance (2 items), respiratory problems (2 items), quantity (1 item), perceived adequacy (2 items), and somnolence (3 items). All items were given equivalent weightage from 1 to 6. Each index summarizes information across most or all sleep dimensions. The total score is transformed linearly to a common metric with a possible range of 0-100 and is averaged across items in the same scale. The higher score indicates a greater degree of the attribute implied by the scale name. Change from randomization was calculated by randomization value minus the value at Week 6. Randomization was defined as Week 0.|Randomization (Week 0) and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1220191|NCT00733980|Secondary|Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. The CGI –responders, are defined as participants with a score of 1 (very much improved) or 2 (much improved) in the CGI-I).|Weeks 1, 2, 4, and 6.||||perecntage of participants|||Number
1220413|NCT00732940|Secondary|Median Percent Change From Baseline in Complement C4 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220192|NCT00733980|Secondary|Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. Both the CGI-I and CGI-S items are rated on a 1 to 7 point scale. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). Scores, on the CGI-S, range from 1 (normal, not ill at all) to 7 (amongst the most extremely ill). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Weeks 1, 2, 4, and 6.|ITT population|||Scores on scale||Standard Error|Least Squares Mean
1220193|NCT00733980|Secondary|Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6)|"The time to maintained antidepressant response at the end of treatment phase (week 6), as the participants with a > or = to 50 % reduction from randomization in their HAMD-17 total score, sustained until the end of the Treatment Phase [Week 6]). This OM time to maintained antidepressant response was not evaluated due to lower number of participants in the GSK561679 group as compared to placebo"|Week 6|Endpoint not evaluated.||||||
1220194|NCT00733980|Secondary|Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.|HAMD-17 Responders were defined as the participants with a > or = 50% reduction from randomization in their HAMD-17 total score at Weeks 1, 2, 4, and 6. The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranged from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicated at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity.|Weeks 1, 2, 4, and 6.|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1220195|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)|The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranges from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2, 4 and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1220196|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.|The IDS-SR is self-report rating scale that assesses symptom severity of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), diagnostic criterion for major depressive disorder. The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. Each item has a 4-likert scale and each symptom item is given equivalent weightings and scored on 0 to 3 scale, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2,3, 4 and 6). Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2, 3,4 and Week 6|ITT population|||Scores on scale||Standard Error|Least Squares Mean
1220197|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)|HAM A, is internationally accepted and validated measurement tool for assessment of severity of anxiety symptoms. Used to assess severity of overall anxiety in participants who met criteria for anxiety of depressive disorders and to monitor outcome of treatment. Instrument does not distinguish symptoms of specific anxiety disorder or distinguish an anxiety disorder from an anxious depression. It is clinician-administered and consists of 14 individual questions, each rated on five point scale from 0 (not present) to 4 (very severe). Total HAM A range from 0 to 56 with higher scores reflecting more severe anxiety. Change from randomization was defined as post-baseline value minus value at randomization. Randomization was defined as Week 0. Provided no more than 1 response was missing for any one visit assessment for a participant, total score was calculated adjusting for missing data as follows: Total score = (14/13)* observed total score the score was rounded to nearest integer number.|Randomization (Week 0) and Week 1, 2, 4 and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1220198|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.|The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2 and 4). Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2 and 4|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1220214|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
1220215|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
1220387|NCT00733135|Primary|Successful Revascularization|Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory|at the end of the procedure|Number of lesions assessed by the angiographic core lab|||percentage of lesions|Participants|95% Confidence Interval|Number
1220199|NCT00733980|Primary|Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17).|The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Week 6|Intent to Treat (ITT) population consisted of all participants who gave informed consent, were randomized, received at least one dose of double-blind medication, and had at least one post-randomization efficacy assessment available (HAM D, IDS-SR CGI, HAM A, MOS, PSS).|||Scores on scale||Standard Error|Least Squares Mean
1220200|NCT00733954|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment|Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|Safety|||Participants|||Number
1220201|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||% BSA||Standard Deviation|Mean
1220202|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||% BSA||Standard Deviation|Mean
1220203|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment|Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||% BSA||Standard Deviation|Mean
1220204|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||% BSA||Standard Deviation|Mean
1220205|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment|Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF|||% BSA||Standard Deviation|Mean
1220206|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment|Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF|||% BSA||Standard Deviation|Mean
1220207|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
1220208|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
1220209|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
1220210|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
1220211|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
1220212|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
1220217|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst from Baseline to after 2 weeks of treatment|Baseline and Week 2||||Participants|||Number
1220218|NCT00733954|Primary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|Intent-to-treat (ITT), Last observation carried forward (LOCF)|||Participants|||Number
1220219|NCT00733824|Secondary|Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event||30 days post transplant||||participants|||Number
1220220|NCT00733824|Secondary|Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype||1 year||||mean percentage of total CD34+ cells||Standard Deviation|Mean
1220221|NCT00733824|Secondary|Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration||From baseline to Day 1||||fold change||Full Range|Median
1220222|NCT00733824|Primary|Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study|Dose limiting toxicity: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.|7 days from first dose of IV AMD3100||||participants|||Number
1220223|NCT00733824|Primary|Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only)|"MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose.~DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause."|7 days from first dose of IV AMD3100||||micrograms/kilograms|||Number
1220224|NCT00733746|Secondary|Response Rate|The response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib and rates of accurate pathologic assessment of the resected tumor specimen according to College of American Pathology guidelines will be estimated with a binomial point estimate and corresponding 95% confidence intervals.|Up to 4 years postoperative chemotherapy treatment|All patients that completed neoadjuvant treatment and were eligible for protocol surgery were included in this endpoint.|||proportion of patients||95% Confidence Interval|Number
1220225|NCT00733746|Secondary|Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI’s Common Toxicity Criteria for Adverse Events|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. These patterns will be summarized with descriptive statistics. The number of patients reporting grade 3 or higher adverse events as graded by the NCI’s Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.|Up to 4 years postoperative chemotherapy treatment|All patients that started protocol treatment and were assessed for adverse events were included in this endpoint.|||Participants|||Count of Participants
1220226|NCT00733746|Secondary|Relapse/Progression-free Survival|Relapse/progression-free survival is defined as the time from date of registration to the date of documentation of disease recurrence/progression. If a patient dies without documentation of disease recurrence/progression, the patient will be considered to have had disease recurrence/progression at the time of their death unless there is sufficient documented evidence to conclude no recurrence/progression occurred prior to death. If a patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation occurred. If a patient is lost to follow-up, s/he will be censored at the data of last contact. The distribution of disease-free survival will be estimated using the method of Kaplan and Meier.|At 2 years post-registration|All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.|||months||95% Confidence Interval|Median
1220227|NCT00733746|Secondary|Resection Rate|"The resection rate is defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1) following neoadjuvant treatment with gemcitabine plus erlotinib.The resection rate will be estimated by the binomial point estimate, i.e. as the number of patients that undergo the planned surgery with removal of the primary tumor following neoadjuvant treatment with gemcitabine plus erlotinib divided by the number of evaluable patients. This quantity will also be estimated with a 95% binomial confidence interval.~Curative resection (R0) is defined as macroscopically and microscopically complete resection (with microscopic surgical margin assessment according to AJCC Staging Principles).~An R1 resection is defined as macroscopically complete tumor removal with any positive microscopic surgical margin (bile duct, pancreatic parenchyma, or SMA margins)."|Up to 4 years postoperative chemotherapy treatment|All patients that completed neoadjuvant treatment and were eligible for surgery were included in this endpoint.|||proportion of patients||95% Confidence Interval|Geometric Least Squares Mean
1220228|NCT00733746|Primary|Overall Survival at 2 Years|The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.|At 2 years post-registration|All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.|||proportion of patients||95% Confidence Interval|Number
1220229|NCT00733512|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|1 week to 10 months|contrast sensitivity data was received for only 51 of 146 patients.|||log units||Standard Deviation|Mean
1220230|NCT00733512|Primary|Visual Acuity|Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.|1 week to 10 months||||logMAR||Standard Deviation|Mean
1220231|NCT00733499|Primary|Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.|The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint|6 Months Post Surgery|The number of participants analysed is based on the number of case report forms measuring the VAS pain score that we have in our database at the 6 month time point.|||units on a scale||Standard Deviation|Mean
1220232|NCT00733421|Secondary|Patient Assessed Quality of Life|Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life|At 16-week post surgery follow-up||||score on a scale||Standard Deviation|Mean
1220233|NCT00733421|Secondary|Patient Assessed Overall Satisfaction With Surgery/Outcome|overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.|16 weeks||||Patients.|||Number
1220234|NCT00733421|Secondary|Satisfaction With Pain Medication|satisfied or unsatisfied with study medication, assessed by patient in questionnaire|during the first 20 days after surgery, 1st outpatient clinic visit||||patients|||Number
1220235|NCT00733421|Secondary|Wound Healing|healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad|16 week follow-up||||patients|||Number
1220236|NCT00733421|Secondary|Dizziness/Sleepiness|Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire|During the 7-day pain medication period||||patients|||Number
1220237|NCT00733421|Secondary|Gastro-intestinal Symptoms|Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire|during the 7- day pain medication period||||patients|||Number
1220238|NCT00733421|Secondary|Compliance to Base Medication|Number of patients that did not discontinue study medication before day 7|7-day study period, during study medication||||patients|||Number
1220239|NCT00733421|Secondary|Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain|VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70|The first 7 days after surgery, during study pain medication||||scores on a scale||Standard Deviation|Mean
1220240|NCT00733421|Primary|Number of Patients Requiring Rescue Medication|Number of patients requiring any further pain medication|7 day study period||||patients|||Number
1220241|NCT00733408|Secondary|Changes in Levels of Circulating Endothelial Cells|Descriptive statistics, such as mean and standard deviation, will be summarized for circulating endothelial cells at baseline and last visit.|Baseline to up to 8 years||||log10 of CEC per mL||Standard Deviation|Mean
1220242|NCT00733408|Secondary|Changes in Levels of Circulating Tumor Cells|Descriptive statistics, such as mean, standard deviation, and range, will be summarized for circulating tumor cells at baseline and last visit.|Baseline to up to 8 years||||log10 of CTC per mL||Standard Deviation|Mean
1220243|NCT00733408|Secondary|EGFR and SPARC Expression in the Primary Tumor||Up to 8 years|Data published that shows that running assay does not provide useful results||||||
1220244|NCT00733408|Secondary|Incidence of Adverse Events as Assessed by National Cancer Institute CTCAE Version 3.0|Adverse events that meet severity grade 2 or greater will be collected and reported. The number and percent of subjects reporting adverse events (all, severe or worse, serious and related) will be summarized for all patients, and stratified by center and other subgroups of interest.|Up to 30 days after treatment discontinuation|Of the 59 patients enrolled, 4 patients failed to complete a single cycle of induction and considered invaluable and therefore were removed from efficacy analysis. Safety analysis included all 59 patients.|||Participants|||Count of Participants
1220245|NCT00733408|Secondary|Percentage of Participants With Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 8 years||||percentage of participants||90% Confidence Interval|Number
1220246|NCT00733408|Secondary|Overall Survival|Kaplan-Meier survival curves will be used.|Time from date of registration to date of death due to any cause, assessed up to 8 years||||Months||95% Confidence Interval|Median
1220247|NCT00733408|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.|Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years||||Months||95% Confidence Interval|Median
1220248|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1220249|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (4Inv & 4Contr)+ 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220250|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 13 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 3 Missing outcome (0Inv & 3Contr)}|||Points|Participants|Standard Deviation|Mean
1220251|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220252|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220253|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220254|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220255|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1220256|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220276|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|2 years|106 knees enrolled, 16 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220257|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220258|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220259|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1220260|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220261|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220262|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220263|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1220264|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 enrolled knees, 15 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1220265|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 enrolled knees, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome ( 0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1220266|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220267|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early to slow recruitment rate. 5 Year data not available.||||Participants||
1220268|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220269|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220270|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220271|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.||||Participants||
1220272|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|106 knees enrolled, 17 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 2 Missing outcome (0Inv & 2Contr)}|||Points|Participants|Standard Deviation|Mean
1220273|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 year|106 knees enrolled, 12 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220274|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220275|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.||||Participants||
1220306|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|12 weeks|There were 32 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
1220277|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220278|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220279|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|Study terminated early due to a slow recruitment rate. 5 year data not available.||||Participants||
1220280|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|106 enrolled knees, 18 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 4 revisions (1 Inv, 1 Contr) + 3 Lost to follow up (2 Inv, 1 Contr) + 3 missing outcome (0 Inv, 3 Cntr)}|||Points|Participants|Standard Deviation|Mean
1220281|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|106 enrolled knees, 11 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 2 lost to follow up (1 Inv, 1 Contr) + 1 missing outcome (1 Inv, 0 Contr) }|||Points|Participants|Standard Deviation|Mean
1220282|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1220283|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1220284|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 knees enrolled, 16 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}|||Points|Participants|Standard Deviation|Mean
1220285|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from the analysis due to:{0 Deaths+ 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}|||Points|Participants|Standard Deviation|Mean
1220286|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to:{0 deaths + 8 Protocol Violations + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220307|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|8 weeks|There were 20 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
1220287|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate, 5 year data not available.||||Participants||
1220288|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 16 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}|||Points|Participants|Standard Deviation|Mean
1220289|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}|||Points|Participants|Standard Deviation|Mean
1220290|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220291|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to a slow recruitment rate.||||Participants||
1220292|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1220293|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1220294|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220295|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study was terminated early due to a slow recruitment rate. 5 year data not available.||||Participants||
1220388|NCT00733096|Secondary|Medication Reduction|Number of people who reduced medications|1 month|Patients who underwent epidural steroid injections|||participants|||Number
1220296|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 1 Contr)+ 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1220297|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1220298|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220299|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study has been terminated early, therefore the 5 year data was not collected.||||Participants||
1220300|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1220301|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1220302|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1220303|NCT00733369|Primary|Change From Pre-op to 1 Year Range of Motion.|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational &4 control) + 2 lost to follow up (1 Inv & 1 Contr) + 1 missing outcome (1 Inv & 0 Contr)}|||Degrees|Participants|Standard Deviation|Mean
1220304|NCT00733356|Primary|Gray Oral Reading Rest, Fourth Edition (GORT-4)|"The GORT-4 evaluates oral reading rate, accuracy and comprehension. Both Forms A and B were used.Half of the subjects randomly were tested on From A at baseline and the other half were tested with Form B.~The GORT-4 is a standardized measure/test. Scores provided are standard scores, which range from 1 to 20, with a Mean of 10 and Standard Deviation of 3. A higher score means better reading performance. There was no total score used or calculated in this study."|baseline and final day (lab school Assessments)||||units on a scale||Standard Deviation|Mean
1220305|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|6 months|There were 13 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
1220308|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|4 weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.|||Feet||Standard Deviation|Mean
1220309|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest). Pre-operatively, the subject must complete both a practice walk and a test walk.|pre-op|There were 5 missing outcomes for this endpoint.|||Feet||Standard Deviation|Mean
1220310|NCT00733330|Secondary|To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.|An independent radiographer will observe and record alignment|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
1220311|NCT00733330|Secondary|To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographer will observe and record alignment.|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
1220312|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|6 months|There were 12 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||millimeters||Standard Deviation|Mean
1220313|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|12 Weeks|There were 37 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||millimeters||Standard Deviation|Mean
1220314|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|8 Weeks|There were 26 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow up for this endpoint.|||millimeters||Standard Deviation|Mean
1220315|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|4 Weeks|There were 23 missing outcomes and 1 Consent Withdrawal for this endpoint.|||millimeters||Standard Deviation|Mean
1220316|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|pre-op|There were 3 missing outcomes for this endpoint.|||millimeters||Standard Deviation|Mean
1220317|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|5 years|The study was terminated early for business reasons therefore there are no outcomes for this endpoint.||||||
1220318|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|2 years|There were 44 missing outcomes, 3 Protocol Violations, 1 Consent Withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1220319|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|1 year|There were 25 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1220333|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|The study was terminated before completion due to business purposes, therefore no outcomes are available for this endpoint.||||||
1220320|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|6 months|There were 16 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1220321|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|12 weeks|There were 36 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1220322|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|8 weeks|There were 22 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1220323|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|4 Weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.|||points||Standard Deviation|Mean
1220324|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|pre-op|There were 4 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
1220325|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|The study was terminated before completion due to business purposes, therefore there are no results for this outcome.||||||
1220326|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|There were 41 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1220327|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 Year|There were 21 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
1220328|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|6 Months|There were 10 missing outcomes, 1 protocol violation, 1 consent withdrawal and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
1220329|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|12 Weeks|There were 33 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
1220330|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 protocol violation, and 1 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1220331|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this outcome.|||points||Standard Deviation|Mean
1220332|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|pre-op|There were 2 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
1220334|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|There were 41 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.|||points||Standard Deviation|Mean
1220335|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|There were 22 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.|||points||Standard Deviation|Mean
1220336|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|6 Months|There were 10 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
1220337|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|12 Weeks|There were 32 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
1220338|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
1220339|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this endpoint.|||points||Standard Deviation|Mean
1220340|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Pre-op|Of the 84 subjects who received surgery, there were 3 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
1220341|NCT00733330|Secondary|To Compare the Number of Optimal Implantations Achieved From Pre-op to 6-12 Weeks Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.|4 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
1220342|NCT00733330|Secondary|To Compare the Proportion of Procedures That Fall Within a Satisfactory Alignment Window Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographic observer will determine and record alignment.|operative|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
1220343|NCT00733330|Primary|To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)|6 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed.||||||
1220344|NCT00733304|Secondary|Number of Participants With Lesion Types Over Period|Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported.|Up to 6 months|Safety population.|||Participants|||Count of Participants
1220345|NCT00733304|Secondary|Change in Neo-vascular Size and Lesion Size Over Period|The analysis was planned to be performed up to 6 months; however, due to heterogeneity of the population and the low likelihood of the utility of the data, the anatomic effects of the pazopanib treatment in this treatment were limited to investigator determined assessment of OCT central subfield retinal thickness. Thus, the study team decided not to have DARC (central reading center) perform the grading for the secondary PD outcomes like lesion size and change with respect to time were not analyzed. Thus, data was not collected for this outcome measure.|Up to 6 weeks|PD population was planned for analysis of this outcome; however, Data was not collected for this outcome measure.||||||
1220346|NCT00733304|Secondary|Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months|The OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of Pazopanib. The anatomic effects of pazopanib treatment were limited to investigator determined assessment of OCT central subfield retinal thickness due to heterogeneity of participant population and the low likelihood of utility of central reading center determination. The OCT equipment used was approved by central OTC reading center. OCT scans were collected at indicated time points and were evaluated by Investigator. Thus, grading of further secondary objectives was not performed as per the study team. Change from Baseline is the value at indicated time point minus the Baseline value. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.|From Baseline (Screening visit) and up to 5 months|Pharmacodynamic subpopulation included participants that were analyzed for PD outcome measures. Only the participants available at the time of assessment were analyzed.|||Microns||Standard Deviation|Mean
1220347|NCT00733304|Secondary|Change From Baseline (Screening Visit) in BCVA at Month 2 and 5|Change from Baseline in BCVA is the value at indicated time point minus the Baseline value. BCVA at screening visit was used as statistical Baseline. Only data before post-dose intravitreal injection of Avastin/ Lucentis (IVT) has been presented. Arithmetic mean was presented as data values; however statistical analysis is based on means of observed case (OC) data. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.|From Baseline (screening visit), Month 2, and Month 5|Efficacy population included all participants in safety population who have classic choroidal neovascularization present as detected by fluorescein angiography in the previous screening visit.|||Number of letters||Standard Deviation|Mean
1220348|NCT00733304|Primary|Number of Participants With Abnormal (Dilated) Fundus Examination|Dilation of fundus was examined post dosing up to 6 months. Number of participants with abnormal change from Baseline indicating dilation of fundus of eye was reported. Change from Baseline was the value at indicated time point minus the Baseline value. The abnormalities were posterior vitreous separation, pale optic nerve, fluid in the posterior pole, drusen, thick arterio-venous changes, pigment changes, cystoids, macular edema, drying of posterior fluid or sub-retinal fluid, underlying central atrophy, and retinal pigment epithelial changes etc. Refraction measurement were determined at the screening and 2 month/5 month visits in order to determine BCVA.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1220349|NCT00733304|Primary|Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function|Meibomian gland dysfunction was measured as obvious insipisation/debris, mild injection, no trichiasis or lid thickening; inspisation, debris, obvious injection, lid thickening, may have trsichiasis; or a two step worsening. Any 2+ worsening of Meibomian gland function was considered a value of PCI.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1220350|NCT00733304|Primary|Number of Participants With Abnormal Tear Films of PCI|Tear film abnormalities were based on the clinical judgment of investigator. Tear film thickness was analyzed and it was reported whether the film was increased or decreased or was normal. Presence of debris or mucus was also reported. Other test were tear lake analysis and checking of discharge from eyes.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1220351|NCT00733304|Primary|Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale|A two step change in any of the lens opacity categories was considered a value of PCI. Aphakia (surgical removal of lens) or pseudophakia was noted if any. Stroma opacity or edema was measured by investigator when it was detected as edema or opacity in stroma.|Approximately up to 6 months|Safety population|||Participants|||Count of Participants
1220352|NCT00733304|Primary|Number of Participants With Abnormal Corneal Examination of PCI|A two step change in any of the lens opacity categories was categorized as of PCI. Corneal epithelium was defined as abnormal when punctate keratopathy was measured as mild, moderate, severe; epithelial edema was measured as subtle epithelial haze, mild patchy microcystic changes, diffuse microcystic changes, and/or investigator determined abnormality. Stromal opacity/ edema was measured by investigator when stroma identifies opacity or edema. Corneal staining was measured as obvious (<=20) localized or diffuse punctate staining areas, severe localized or diffuse punctate staining. Participants were analyzed for any of the mentioned abnormality over 6 weeks (up to follow-up period).|Approximately up to 6 months|Safety population|||Participants|||Count of Participants
1220353|NCT00733304|Primary|Number of Participants With Abnormal Anterior Chamber Examination of PCI|A two step worsening in the anterior chamber examination was considered a value of PCI. The participants were examined for any anterior chamber abnormality. Fibrinous response and obvious aqueous haze were considered abnormalities related to anterior chamber examination.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1220354|NCT00733304|Primary|Number of Participants With Abnormal Conjunctival Examination of PCI|A two step worsening in the conjunctival examination was considered a value of PCI. Participants were analyzed for conjunctival examination up to follow-up (6 months).|Up to follow-up (approximately 6 months)|Safety population.|||Participants|||Count of Participants
1220355|NCT00733304|Primary|Number of Participants With Abnormal Pupil Examination of PCI|Pupil abnormalities were of different types. Meibomian gland dysfunction was measured as obvious inspissation (debris). Mild injection, no trichiasis (lid thickening), or two step worsening was analyzed. Afferent pupillary defect, motility examination, PERRL, confrontation visual field was measured as a new definite abnormality. Left and right both eyes were examined.|Up to follow-up (approximately 6 months)|Safety population.|||Participants|||Count of Participants
1220356|NCT00733304|Primary|Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)|Visual acuity was measured over 5 months and also during follow-up period. Visual acuity was measured using standardized early treatment of diabetic retinopathy study (ETDRS) visual acuity charts. Visual acuity measurement was performed by an examiner that had been appropriately trained. Screening, Month 2 and Month 5 data were considered as Best Corrected Visual Acuity (BCVA) data. A loss of greater than or equal to 15 letters in BCVA from Baseline was considered of PCI. Data for number of participants who met the criteria for PCI have been presented.|Approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1220357|NCT00733304|Primary|Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)|Number of participants with ocular and non-ocular AEs and SAEs were separately recorded. An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1220389|NCT00733096|Secondary|Global Perceived Effect|Satisfaction. Number of participants with positive perceived global satisfaction.|1 month|Subjects who underwent epidural steroid injections|||participants|||Number
1220358|NCT00733304|Primary|Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis|In this dipstick test, the level of blood occult and glucose, ketones, protein in urine samples were recorded as negative, trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive).|Approximately up to 6 months (up to follow-up)|Safety population. Only those participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1220359|NCT00733304|Primary|Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Intra-ocular pressure was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1220360|NCT00733304|Primary|Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. MCV was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed|||Femtoliters||Standard Deviation|Mean
1220361|NCT00733304|Primary|Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period|Change from Baseline (Day 1) is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Calcium, chloride, carbon di oxide equivalent content (CO2), glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
1220362|NCT00733304|Primary|Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Direct bilirubin, total bilirubin, and creatinine were recorded from Baseline up to 6 months|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Micromoles per Liter (umol/L)||Standard Deviation|Mean
1220363|NCT00733304|Primary|Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Over here, the change is % Basophils at month x - % Basophils at Baseline. Baseline measurement was recorded at Day 1. Percentage change in the hematological parameter mentioned above was recorded from Baseline up to 5 months.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||Percentage of cells||Standard Deviation|Mean
1220364|NCT00733304|Primary|Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. The above mentioned hematological parameters were recorded from Baseline up to 5 months.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||Giga per Liter (G/L)||Standard Deviation|Mean
1220365|NCT00733304|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period|ALP, ALT and AST values were measured over 5 months and till the follow-up period. Baseline value was recorded pre-dose Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||International units per Liter (IU/L)||Standard Deviation|Mean
1220366|NCT00733304|Primary|Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period|Albumin and hemoglobin values were recorded at Baseline, Month2, and till follow-up (Month 6). Baseline was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1), Month 2, 5 and approximately up to Month 6|Safety population. Only the participants available at the time of assessment were analyzed.|||Grams per liter||Standard Deviation|Mean
1220367|NCT00733304|Primary|Change From Baseline (Day 1) in Heart Rate Over Period|Heart rate was measured over 6 months. Baseline value was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Heart rate measurement were repeated in case it was in range < 50 beats per minute (bpm) or >110 bpm.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||bpm||Standard Deviation|Mean
1220368|NCT00733304|Primary|Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. SBP and DBP were recorded from Baseline up to 6 months. At screening and Baseline, if the single measured value of blood pressure was above 150 millimeters of mercury (mm Hg) systolic or 95 mm Hg diastolic, then blood pressure measurement could not be repeated. If, the SBP was <80 or >140 mm Hg and DBP was <40 or >90 mm Hg, then measurement of BP was repeated. Three consecutive blood pressure readings that were less than 150 mmHg systolic and 95 mmHg diastolic were taken with each measurement separated by at least 1 hour.|Baseline (Day 1) and approximately up to 6 months|Safety population included all participants who received at least one dose of the study drug. Only those participants available at the time of assessment were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1220369|NCT00733291|Primary|Total Corneal Staining Type|Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
1220390|NCT00733096|Secondary|Oswestry Disability Score|0-100%. 0= no disability, 100% is complete disability|1 month|Patients who received epidural steroid injections|||percentage of disability out of 100%||95% Confidence Interval|Mean
1220370|NCT00733291|Secondary|Ocular Redness|"Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes look... with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red."|After two hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
1220371|NCT00733291|Primary|Average Corneal Staining Area|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Percentage area of cornea||Standard Deviation|Mean
1220372|NCT00733291|Secondary|Ocular Comfort|"Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes feel... with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable."|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
1220373|NCT00733278|Secondary|Visibility Within the Vagina of IUD Strings at All Times.||At 3 days, 2 weeks and 6 weeks postpartum||||participants|||Number
1220374|NCT00733278|Primary|Successful Retention of IUD||6 weeks||||participants|||Number
1220375|NCT00733226|Secondary|Effect of OM-85 BV on Cytokine Levels|Cytokine levels were not measured during the trial because of unavailability of laboratory resources.|6 months|||||||
1220376|NCT00733226|Secondary|Duration of Hospitalization/Per Patient|Over the 12 months of the study we calculated mean duration of hospitalization/per patients.|12 months||||day/per patient||Standard Error|Mean
1220377|NCT00733226|Secondary|Number of Hospitalizations|"During the study period of 12 months all hospitalizations for wheezing attacks were recorded.~Over the 12 months of the trial mean number of hospitalizations/per patients were calculated.~This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial."|12 months||||hospitalization/per patient||Standard Error|Mean
1220378|NCT00733226|Secondary|Number of Wheezing Attacks That Required Systemic Steroid Therapy|"All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study.~At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group."|12 months||||wheezing attacks/per patient||Standard Error|Mean
1220379|NCT00733226|Secondary|Number of Common Cold|"All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial.~This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial."|12 months||||common cold/per patients||Standard Error|Mean
1220380|NCT00733226|Secondary|Mean Duration (in Day) of Wheezing Attacks Per Patient|Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks.|12 months||||day/per patient||Standard Error|Mean
1220381|NCT00733226|Primary|Mean Rate of Wheezing Attacks|Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.|12 months||||wheezing attacks/per patient||Standard Error|Mean
1220382|NCT00733135|Secondary|Preservation of Run-off Distal to the Filter|Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.|at the end of the procedure|115/133 subjects had the required angiographic images to assess this outcome.|||percentage of participants|||Number
1220383|NCT00733135|Secondary|Presence of Debris in Deployed SpiderFx™ Embolic Protection Device|Presence of debris in deployed SpiderFx™ embolic protection device|at the end of the procedure||||percentage of deployed filters|Participants||Number
1220384|NCT00733135|Secondary|Residual Diameter Stenosis|This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.|at the end of the procedure|1 lesion not included because there is no angiographic core laboratory post-treatment data available|||percentage of lesions|Participants||Number
1220385|NCT00733135|Secondary|Technical Procedural Success|"Technical Procedural Success was defined as meeting all of the following requirements:~Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory~No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)~No device malfunction causing the procedure to be aborted~Successful delivery and placement of the SpiderFX™ embolic protection device"|at the end of the procedure|Total patient population minus one patient because there was no angiographic post-treatment core lab data available.|||percentage of participants|||Number
1220386|NCT00733135|Primary|Major Adverse Event Free Rate 30 Days|MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).|30 Days||||percentage of participants||95% Confidence Interval|Number
1220391|NCT00733096|Primary|Numerical Rating Leg Pain Score|0-10 pain score. 0= no pain, 10= worst imaginable pain.|1 month|Patients who received epidural steroid injections|||units on a scale||95% Confidence Interval|Mean
1220392|NCT00733005|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.|15 days of treatment|Standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
1220393|NCT00733005|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|Standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
1220394|NCT00732992|Secondary|Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants|Complete response (CR): disappearance of all target lesions; Partial response (PR): >=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): >=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of >=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started.|End of study (Up to individual study discontinuation)|Evaluable subjects = defined as all subjects who met all the following 3 requirements: 1) met the eligibility (inclusion and exclusion) criteria, 2) received at least 1 dose of the study drug, and 3) assessed appropriately at the baseline and had a measurable lesion based on the RECIST.|||Participants|||Number
1220395|NCT00732992|Secondary|Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose|Participants who provided a plasma concentration data was included in the analysis|||nanogram/mL||Standard Deviation|Mean
1220396|NCT00732992|Secondary|Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|"Terminal phase elimination half-life was calculated as natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)."|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||hours||Standard Deviation|Mean
1220397|NCT00732992|Secondary|AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct*/kel), where Ct* was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||microgram*hour/mL||Standard Deviation|Mean
1220398|NCT00732992|Secondary|Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1||Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||microgram/mL||Standard Deviation|Mean
1220399|NCT00732992|Secondary|Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||hours||Full Range|Median
1220400|NCT00732992|Secondary|AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||nanogram*hour/mL||Standard Deviation|Mean
1220401|NCT00732992|Secondary|Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||nanogram/mL||Standard Deviation|Mean
1220402|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 50 mg/Day Schedule-2/1 Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 6|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."|||percent of total planned dose||Full Range|Median
1220403|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 37.5 mg/Day Continuous Daily Dosing Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 5 (end of study)|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."|||percent of total planned dose||Full Range|Median
1220404|NCT00732992|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.|End of study (up to individual discontinuation)|All subjects who received at least 1 dose of the study drug.|||Participants|||Number
1220418|NCT00732940|Secondary|Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 Weeks|LOCF|||Points on a scale||Standard Error|Mean
1220419|NCT00732940|Secondary|Mean Percent Change From Baseline in PGA Score at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|LOCF|||Percentage||Standard Error|Mean
1220420|NCT00732940|Secondary|Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24|PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Last Observation Carried Forward (LOCF)|||Scores on a 3-point scale||Standard Error|Mean
1220421|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220422|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
1220423|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220424|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mL||Standard Error|Mean
1220425|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220426|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
1220427|NCT00732940|Primary|Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220428|NCT00732940|Primary|Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
1220429|NCT00732940|Secondary|Median Percent Change From Baseline in IgM at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220430|NCT00732940|Secondary|Absolute Change From Baseline in IgM at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
1220431|NCT00732940|Secondary|Median Percent Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220432|NCT00732940|Secondary|Absolute Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
1220433|NCT00732940|Secondary|Median Percent Change From Baseline in IgA at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1220434|NCT00732940|Secondary|Absolute Change From Baseline in IgA at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
1220435|NCT00732940|Secondary|Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||µg/mL||Standard Deviation|Mean
1220436|NCT00732940|Primary|Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 24 weeks|Please see Adverse Events Section|||Percentage of participants|||Number
1220437|NCT00732901|Secondary|Cocaine Positive Urines|Number of urine drug screens positive for cocaine metabolite benzoylecgonine.|5 weeks of treatment||||Positive urine drug screens|||Number
1220438|NCT00732901|Secondary|Attentional Bias as Measured by the Cocaine Stroop Task.|Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.|5 weeks of treatment||||milliseconds||Standard Deviation|Mean
1220439|NCT00732901|Primary|Immediate Memory Task|The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer’s left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or ‘false alarms’. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.|after acute dose and after chronic administration|Numerical data values are not accessible because PI transferred institutions. See references.||||||
1220440|NCT00732875|Primary|Number of Subjects Experiencing Any Infection||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study|||participants|||Number
1220441|NCT00732875|Primary|Number of Subjects Experiencing Serious Adverse Event|Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.|throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.|||participants|||Number
1220443|NCT00732758|Secondary|Collagen Type 1 Cross-linked C-telopeptide (CTx)|Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.|6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing participants with 6 month CTx data.|||ng/mL||Standard Deviation|Mean
1220444|NCT00732758|Secondary|Osteocalcin (OC)|Marker of bone formation|6 months|Intention to treat with participants analyzed in the group to which they were assigned but only using participants with 6 month OC data available.|||ng/mL||Standard Deviation|Mean
1220445|NCT00732758|Secondary|Parathyroid Hormone (PTH) Dietary Data||6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing those participants with follow up data for PTH at 6 months.|||pg/mL||Standard Deviation|Mean
1220446|NCT00732758|Primary|Serum 25-hydroxyvitamin D|Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL.|6 months|Intention to treat -- participants analyzed based on the group to which they were randomized but only included in the analysis if they had follow up data at 6 months.|||ng/mL||Standard Deviation|Mean
1220447|NCT00732680|Primary|Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)|The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.|2 weeks after intervention, 2 months|No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.||||||
1220448|NCT00732654|Primary|Oral Food Challenge Threshold (OFC) Threshold|mg CM protein|Change from baseline to after therapy (up to 18 months)||||mg||Full Range|Median
1220449|NCT00732654|Primary|Change in End Point Skin Test|Allergen provoked skin test (mm)|Change from baseline to after therapy (up to 18 months)||||mm||Full Range|Median
1220450|NCT00732654|Primary|Change in CM-specific Immunoglobulin G4 (IgG4)|Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L)|Change from baseline to after therapy (up to 18 months)||||kUa/L||Full Range|Median
1220451|NCT00732654|Primary|Change in CM-specific Immunogloblin E (IgE)|Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)|Change from baseline to after therapy (up to 18 months)|Data was not collected for one participant in the SLIT/OIT A group.|||kUa/L||Full Range|Median
1220452|NCT00732641|Secondary|Quality of Life|Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions. The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social). All of the scales ranged in score from 0 (worst) to 100 (best).|Screening and Last Observation (up to 5 years)|"Intent-to-treat population (those who received at least one dose of study drug).~The number of participants analyzed varied depending on the number of observations available for each category."|||Score on a scale||Standard Deviation|Mean
1220453|NCT00732641|Secondary|Number of Participants With Progressive Disease(PD) or Relapse From CR|"PD (for patients not in CR) required one or more of the following:~25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells;~Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas;~Development of hypercalcemia.~Relapse from CR required at least one of the following:~Reappearance of serum or urinary paraprotein;~>5% plasma cells;~Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions;~Development of hypercalcemia."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
1220454|NCT00732641|Secondary|Number of Participants With Minimal Response (MR) to Treatment|"MR was defined as:~A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks;~Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks;~For patients with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;~A 25-49% reduction in the size of soft tissue plasmacytomas;~No increase in the size or number of lityc lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
1220455|NCT00732641|Secondary|Number of Participants With Partial Response (PR) to Treatment|"PR was defined as:~At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks;~Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to < 200 mg, maintained for a minimum of 6 weeks;~For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;~At least 50% reduction in the size of soft tissue plasmacytomas;~No increase in size or number of lytic bone lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
1220456|NCT00732641|Secondary|Number of Participants With Complete Response (CR) to Treatment|"CR was defined as:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks;~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy was performed.~No increase in size or number of lytic bone lesions (development of a compression fracture did not include response);~Disappearance of soft tissue plasmocytomas."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
1220457|NCT00732641|Secondary|Number of Days of Overall Survival (OS)|"OS was calculated from the date of randomization to the date of death for any~cause. Participants alive at the end of study were censored at the last date they were known to be alive. Participants who were still living at the end of the study were censored on the last date they were known to be alive."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)|||Days||95% Confidence Interval|Median
1220487|NCT00732381|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|The standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
1220458|NCT00732641|Primary|Number of Days With Progression Free Survival (PFS)|"PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse.~PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)|||Days||95% Confidence Interval|Median
1220459|NCT00732615|Secondary|Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.|Clinical symptoms were a selected group of adverse events that occurred during study weeks 16 through 24. The group of terms were defined by key opinion leaders and documented in study protocol.|8 Weeks|Intent to Treat (ITT) population.|||percentage of participants|||Number
1220460|NCT00732615|Secondary|Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.|Subjects Who Achieved Independence from Active Vitamin D Usage and with Calcium Dose of 500 mg/day or less. This analysis was based on Investigator Prescribed Data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data.|||percentage of participants|||Number
1220461|NCT00732615|Secondary|Percentage Changes From Baseline in Daily Calcium Dose at Week 24.|The analysis of this endpoint was based on investigator prescribed data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data|||percentage change from baseline||Standard Deviation|Mean
1220462|NCT00732615|Primary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.|Week 24 of dosing|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1220463|NCT00732472|Secondary|Urine Half Life (t1/2) of UMEC on Day 7|Urine half life (t1/2) of UMEC on Day 7 was estimated. Urine samples were collected from 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.|||hours||Geometric Coefficient of Variation|Geometric Mean
1220464|NCT00732472|Secondary|Renal Clearance of UMEC on Day 1 and Day 7|Renal clearance was calculated as the urinary recovery of unchanged drug from time zero to time x (Ae[0-x])/area under concentration from time zero to time x (AUC[0-x]) for the longest period of time after dosing when both could be accurately determined (where x is either 8, 12, or 24). Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||Liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1220465|NCT00732472|Secondary|Fe(0-4), Fe(0-8), Fe(0-12), and Fe(0-24) of UMEC on Day 1 and Day 7|The fraction of the total dose excreted (Fe) in each interval was estimated as the urinary recovery of unchanged drug (Ae) per dose. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population: Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||Percentage of dose administered||Standard Deviation|Mean
1220466|NCT00732472|Secondary|Ae(0-4), Ae(0-8), Ae(0-12), and Ae(0-24) of UMEC on Day 1 and Day 7|Urinary recovery of unchanged drug (UMEC) within the first 8, 12, and 24 hours (Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 1 and within the first 4, 8, 12, and 24 hours (Ae[0-4], Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 7 was estimated. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||nanograms (ng)||Geometric Coefficient of Variation|Geometric Mean
1220467|NCT00732472|Secondary|Tmax and Tlastof UMEC on Day 1 and Day 7|Tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last quantifiable concentration of UMEC; both were measured on Day 1 and Day 7. Blood samples were collected pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||hours||Full Range|Median
1220468|NCT00732472|Secondary|Cmax of UMEC on Day 1 and Day 7|Cmax is defined as the maximum observed concentration of UMEC and was measured on Day 1 and Day 7. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1220469|NCT00732472|Secondary|Mean AUC(0-2), AUC(0-8), and AUC(0-t) of UMEC on Day 1 and Day 7|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 2 hours (AUC[0-2]), from time zero to 8 hours (AUC[0-8]), from time zero to the last time of a quantifiable concentration of UMEC (AUC[0-t]) on Day 1 and Day 7 were measured. AUC is a measure of systemic exposure. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|Pharmacokinetic (PK) Population: participants (par.) in the ASP for whom a PK sample was obtained and analyzed. Different par. may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of par. summarized reflects everyone in the PK Population.|||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1220470|NCT00732472|Primary|Mean Corpuscle Volume (MCV) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCV pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||10^-15 liters (femtoliters)||Standard Deviation|Mean
1220471|NCT00732472|Primary|Mean Corpuscle Hemoglobin (MCH) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCH pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||picograms/cell (pg)||Standard Deviation|Mean
1220472|NCT00732472|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil (ANC: Absolute Neutrophil Count), Platelet, and White Blood Cell (WBC) Count Values on Day 1 and Day 7|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelets, and white blood cell (WBC) count pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1220473|NCT00732472|Primary|Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values on Day 1 and Day 7|Blood samples were collected for the measurement of calcium, glucose, potassium, sodium, and urea/BUN pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1220474|NCT00732472|Primary|Direct Bilirubin, Total Bilirubin, and Creatinine Values on Day 1 and Day 7|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1220475|NCT00732472|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Values on Day1 and Day 7|Blood samples were collected for the measurement of ALP, ALT, AST, and GGT Pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||International units per liter (IU/L)||Standard Deviation|Mean
1220476|NCT00732472|Primary|Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Concentration (MCHC) Values on Day 1 and Day 7|Blood samples were collected for the measurement of albumin, total protein, hemoglobin, and MCHC values pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Grams per liter (G/L)||Standard Deviation|Mean
1220477|NCT00732472|Primary|Total Number of Salbutamol Doses Taken Over the 7 -Day Study Period|The total number of salbutamol doses taken per day was recorded by the participants in their dairy card over the entire 7-day treatment period. Diaries were reviewed by the Investigator when participants were admitted to the unit on Day 1, Day 7, and Day 8. Salbutamol was given as rescue medication, defined as a quick-relief or fast-acting medication that is given in addition to the investigational drug or placebo that can alleviate symptoms due to disease or lack of efficacy of the study treatment.|Day 1 to Day 7|All Subjects Population. Only those participants who took at least one dose of salbutamol were summarized.|||salbutamol doses|||Number
1220478|NCT00732472|Primary|Mean Forced Expiratory Volume in One Second (FEV1) at Screening and on Days 1 and 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured at Screening, pre-dose, and 4 hours (hr) post-dose on Day 1 and Day 7. FEV1 tests were repeated until three technically acceptable measurements were made.|Screening, Day 1, and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Liters||Standard Deviation|Mean
1220488|NCT00732303|Secondary|Overall Survival|To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|No data was collected and analyzed for this outcome measure due to termination of the study.||||||
1220489|NCT00732303|Secondary|Assess Safety and Toxicity|- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|Most frequent toxicities reported.|||participants|||Number
1220479|NCT00732472|Primary|Maximum and Mean (0-24 Hour) Heart Rate From Holter Monitoring on Day 7|Maximum heart rate (Max HR) and mean HR from 0-24 hour Holter monitoring on treatment Day 7 were derived. The analysis was adjusted for treatment and Baseline, where Baseline is defined as the corresponding summary measure (i.e., mean heart rate [0-24 hours] or maximum heart rate [0-24 hours]) from screening records.|Day 7|All Subjects Population. The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.|||Beats per minute||Standard Error|Least Squares Mean
1220480|NCT00732472|Primary|Number of Participants With Abnormal 24-hour Holter Findings at Screening and Day 7|Twenty-four hour Holter ECG values were obtained at Screening and on Day 7. During the Screening procedure and study, standard Holter monitors were used (in order to exclude participants with underlying cardiac arrhythmogenicity). During the treatment periods, Holter monitors were only switched on immediately prior to dosing (up to 15 minutes pre-dose) so as to capture Holter ECG data from the 24 hour period following dosing. The following summary data were transcribed into the Case Report Form: Maximum and mean (0 to24 hour) heart rate; normal and aberrant beats and arrhythmias. Analysis of the Holter tapes was arranged by GlaxoSmithKline.The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at Screening and Day 7, are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Screening and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Participants|||Number
1220481|NCT00732472|Primary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Values on Days 1 and 7|The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose on Day 7 are reported. The following are of potential clinical importance: absolute QTc interval >450 milliseconds (msec); increase from Baseline QTc >60 msec; PR interval <110 and >220 msec; QRS interval <75 and >110 msec. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Day 1 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr)|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Participants|||Number
1220482|NCT00732472|Primary|Maximum and Weighted Mean (0-4 Hour) Heart Rate at Days 1 and 7|Maximum heart rate (Max HR) and weighted mean (WM) from 0-4 hour on Days 1 and 7 were derived. Max HR (0-4 h) is defined as the maximum heart rate attained within 0-4 h. The weighted mean HR (0-4 h) was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Each of the maximum and weighted mean (0-4h) endpoints for heart rate, was statistically analyzed using a mixed effects model. The terms treatment, baseline, day and any relevant interactions were considered in the model. Least squares means are adjusted for treatment, Baseline, day, treatment by Baseline and Baseline by day interaction, where Baseline is defined as the mean of the three pre-dose assessments.|Day 1 and Day 7|All Subjects Population (ASP). The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.|||Beats per minute||Standard Error|Least Squares Mean
1220483|NCT00732472|Primary|Mean Heart Rate (HR) on Days 1 and 7|HR was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. HR was obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Beats per minute||Standard Deviation|Mean
1220484|NCT00732472|Primary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) on Days 1 and 7|Blood pressure was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. SBP and DBP were obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population (ASP). Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1220485|NCT00732472|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any On-treatment Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An on-treatment adverse event is defined as an event that occurred between the start of investigational product and follow-up contact. Refer to the general SAE/non-serious AE module for a complete list of AEs reported in the study. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From start of treatment to study day 12|All Subjects Population: all participants who received at least one dose of study medication|||participants|||Number
1220486|NCT00732381|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment||||Units on a scale||Standard Deviation|Least Squares Mean
1220490|NCT00732303|Primary|Progression Free Survival|To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation|24 months|No data was collected and analyzed for this outcome measure due to termination of the study||||||
1220491|NCT00732251|Secondary|Hamilton Depression Scale (HAM-D)||2 Years|||||||
1220492|NCT00732251|Primary|Young Mania Rating Scale (YMRS)||2 Years|Only 1 subject completed the study. The other 6 withdrew at Week 1, Month 3, Month 5, Month 7, Month 11, and Month 13. Due to the closure of the Psychiatry Dept, the study was terminated; no analysis was completed.||||||
1220493|NCT00732238|Secondary|The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy|Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf)|Up to 180 days of end of therapy||||participants|||Number
1220494|NCT00732238|Primary|The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect||Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)||||participants|||Number
1220495|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 20 DuoVisc eyes, 6 BioVisc eyes,4 Healon5 eyes, and 14 Amvisc Plus eyes.|||Percentage of Eyes|||Number
1220496|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye during Phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 19 DuoVisc eyes, 6 BioVisc eyes,3 Healon5 eyes, and 11 Amvisc Plus eyes.|||Percentage of Eyes|||Number
1220497|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye During Anterior Capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 2 DisCoVisc eyes and 2 Healon5 eyes|||Percentage of Eyes|||Number
1220498|NCT00732225|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure between 10 mmHg and 20 mmHg.|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit with the exception of the following: 3 DisCoVisc patients, 4 DuoVisc patients, 1 Healon5 patient, and 4 Amvisc Plus patients.|||mmHg||Standard Deviation|Mean
1220499|NCT00732225|Secondary|Aqueous Signs - Aqueous Cells|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings:~0 - None~- 1 to 5 cells~- 6 to 15 cells~- 16 to 30 cells~- >30 cells"|1 day following surgery|This data was collected on all eyes of patients attending the 1 day post-operative visit.|||Percentage of Eyes|||Number
1220500|NCT00732225|Secondary|Aqueous Signs – Aqueous Flare|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings:~0-None: No visible flare when compared with the normal eye.~Mild: Flare visible against dark papillary background but not visible against iris background.~Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.~Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit.|||Percentage of Eyes|||Number
1220501|NCT00732225|Secondary|Aqueous Signs - Corneal Edema|"Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings:~0 - None~- Mild, slight localized or generalized edema~- Moderate, significant localized or generalized edema~- Severe, advanced localized or generalized edema"|1 day after surgery|This data was collected on all eyes of patients attending the 1-day visit.|||Percentage of Eyes|||Number
1220502|NCT00732225|Primary|Percent Loss of Endothelial Cells|Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.|2 months following surgery|This data was collected on the eyes of patients attending the visit 2 months after surgery.|||Percent Loss||Standard Deviation|Mean
1220503|NCT00732212|Other Pre-specified|Hospital Days After Randomization|Comparisons of days spent in the ICU and hospital will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Days||Standard Deviation|Mean
1220504|NCT00732212|Secondary|Units of Red Blood Cells (RBC) Transfused for Rebleeding After Randomization|RBC units of transfusion post-randomization will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Units of RBC||Standard Deviation|Mean
1220505|NCT00732212|Secondary|Death|Death up to 30 days from a co-morbid condition, bleeding, or another cause in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
1220506|NCT00732212|Secondary|Rate of Complications|Rates for each treatment group will be determined and compared for General medical complications (pneumonia, infection, myocardial infarction, stroke) & GI procedure related (perforation, aspiration) up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
1220507|NCT00732212|Secondary|Rates of Surgery up to 30 Days After Randomization|GI surgery rate for control of active bleeding or rebleeding - up to 30 days after randomization in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
1220508|NCT00732212|Primary|30 Day Rebleeding Rate|The primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
1220509|NCT00732199|Secondary|Brief Hyperoxia Response|Brief hyperoxia response was the nadir minute ventilation achieved immediately upon exposure to brief hyperoxia expressed as a percent of eupneic minuted ventilation.|4-6 wks for each participant|young adults: 3 women/6 men; older adults: 6 women/4 men; participants with data available were included in the analysis|||percentage of eupneic minute ventilaion||Standard Error|Mean
1220510|NCT00732199|Secondary|Hypoxic Ventilatory Response|Hypoxic ventilatory response was calculated as the change in minuted ventilation for a change in oxygen saturation during each hypoxia trial.|4-6 wks for each participant|older adults: 7 women/6 men; young adults: 6 women/4 men;participants with data available were included in the analysis|||Liter/minute/%saturation||Standard Error|Mean
1220511|NCT00732199|Primary|Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only|Episodic hypoxia (EH) leads to sustained elevation of the ventilatory motor output, referred to as LTF, an excitatory mechanism characterized by a sustained elevation in ventilatory motor output following EH. Minute ventilation during recovery period after multiple trials of EH. This is reported in older adults on this grant.|4-6 wks for each participant|Older adults 8 women/6 men;participants with data available were included in the analysis|||percentage of control minute ventilation||Standard Error|Mean
1220512|NCT00732199|Primary|Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve|The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.|4-6 wks for each participant|Older adults : n=10, 6 females/4 males Young n=15, 8 females/ 7 males; participants with data available were included in the analysis|||mm Hg||Standard Error|Mean
1220513|NCT00732160|Secondary|Insulin Sensitivity|Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.|3 hours|Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.|||mg/kg/min per uU/mL*100||Standard Deviation|Mean
1220514|NCT00732160|Primary|Insulin Secretion|Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)|3 hours|Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.|||uU/mL||Standard Deviation|Mean
1220515|NCT00732069|Secondary|F2-Isoprostanes|Mean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo|During dialysis after one week of study drug||||pg/mL||Standard Error|Mean
1220516|NCT00732069|Primary|Interleukin 1 Beta|Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo|During dialysis after one week of study drug|All participants who completed the three arm treatment.|||pg/mL||Standard Error|Mean
1220517|NCT00732030|Secondary|Patient Satisfaction Survey|Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.|6 months||||Units on a Scale||Standard Deviation|Mean
1220518|NCT00732030|Primary|Residual Refractive Cylinder|Residual Refractive Cylinder at month 6 measured in diopters (D).|6 Month||||Diopters||Standard Deviation|Mean
1220519|NCT00732030|Primary|Best Corrected Distance Visual Acuity|Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|6 Months|Data was collected for 29 eyes in 24 patients.|||logMAR||Standard Deviation|Mean
1220520|NCT00732030|Primary|Uncorrected Distance Visual Acuity|Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|6 months|Data was collected for 29 eyes in 24 patients.|||logMAR||Standard Deviation|Mean
1220521|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|6 months||||units on a scale||Standard Deviation|Mean
1220522|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1220523|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 9|How likely the subject will need continued training or retraining?|6 weeks||||percentage of participants|||Number
1220524|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 8|How easy was it for the subject to learn?|6 weeks||||percentage of participants|||Number
1220525|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 7|The subject likes the OTR pump?|6 weeks||||percentage of participants|||Number
1220526|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 6|The OTR pump was easy to use at 1st cycling?|6 weeks||||percentage of participants|||Number
1220527|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 5|Subject training with OTR pump was easier than with previous pump?|6 weeks||||percentage of participants|||Number
1220537|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|3 months post-surgery||||"% responding yes and probably"|||Number
1220538|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|12 months post-surgery||||"% responding yes and probably"|||Number
1220539|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|6 months post-surgery||||"% responding yes and probably"|||Number
1220540|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|3 months post-surgery||||"% responding yes and probably"|||Number
1220541|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220542|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220543|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220544|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220545|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220546|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220547|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220548|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220549|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220550|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220551|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220552|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220553|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220554|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220555|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220556|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220557|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220558|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220559|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220560|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220561|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220562|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220563|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220564|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1220565|NCT00731939|Primary|Assess the Ease of Deflation of the Titan® OTR Pump|"The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of satisfactory or somewhat satisfactory. Other possible responses were neither satisfactory nor unsatisfactory, somewhat unsatisfactory, and very unsatisfactory."|6 months||||% of participants meeting success criter|||Number
1220566|NCT00731874|Secondary|Development of New Onset Diabetes Mellitus||36 months post-transplant|Only subjects who did not have a diagnosis of diabetes mellitus at transplant are included, per protocol.|||Participants|||Count of Participants
1220568|NCT00731874|Secondary|Severity of Acute Rejection (by Banff Criteria and Need for Anti-lymphocyte Agents to Treat Acute Rejection)||36 months post-transplant|Data reported only for those subjects who developed acute rejection during the study, per protocol. Three of the 5 subjects in Arm 2 with rejection were treated with rabbit anti-thymocyte globulin.|||Participants|||Count of Participants
1220569|NCT00731874|Secondary|Incidence of Acute Rejection|Incidence of biopsy-proven acute rejection|36 months post-transplant||||Participants|||Count of Participants
1220570|NCT00731874|Secondary|Development of Donor Specific Antibody (DSA)|Percent of subjects who developed new donor specific antibody (mean fluorescence intensity > 3,000) after enrollment, within 36 months of transplant|36 months post-transplant||||Participants|||Count of Participants
1220571|NCT00731874|Secondary|Renal Function (Estimated Glomerular Filtration Rate)||36 months post-transplant|Data are not included for one subject because one subject was lost to follow-up.|||Participants|||Count of Participants
1220572|NCT00731874|Secondary|Change in Incidence and Severity of Interstitial Fibrosis/Tubular Atrophy (IF/TA) From Baseline (3 Month Biopsy)|Compared to the baseline biopsy performed at the time of study entry, was there new development (incidence) or progression (severity) of interstitial fibrosis/tubular atrophy (formerly called chronic allograft nephropathy).|36 months post-transplant||||Participants|||Count of Participants
1220573|NCT00731874|Secondary|Graft Survival||36 months post-transplant|Data are not included for one subject because one subject was lost to follow-up.|||Participants|||Count of Participants
1220574|NCT00731874|Secondary|Patient Survival||36 months post-transplant||||Participants|||Count of Participants
1220575|NCT00731874|Primary|Number of Participants With Biopsy-confirmed Acute Rejection and/or Progression of Histologically Proven Chronic Allograft Nephropathy at 15 Months After Transplantation.||15 months post-transplant||||participants|||Number
1220576|NCT00731822|Secondary|Mean Change From Baseline (Pre-dose on Day 1) in Weighted Mean FEV1 (0-4 Hours Post-dose) on Days 1 and 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Day 1 and Day 28 clinic visits (60 minutes pre-dose; immediately pre-dose; post-dose after 5, 15, and 30 minutes and 1, 2, and 4 hours. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the 0 to 4 hours post-dose assessment. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline FEV1 was defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the average Day 28 FEV1 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline (pre-dose on Day 1); Day 1 and Day 28|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1220577|NCT00731822|Secondary|Mean Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) on Days 2, 15, and 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Days 2, 15, and 29 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Days 1, 14, and 28. The highest of 3 technically acceptable measurements was recorded. Baseline FEV1 is defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the Day 29 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline; Day 2, Day 15, and Day 29|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1220578|NCT00731822|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Study|Co-Primary Endpoint. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. See the SAE/AE module of this results summary for a list of specific SAEs/AEs occurring in the study.|From Baseline (Day 1) until Follow-up (up to Study Day 37)|ITT Population|||participants|||Number
1220579|NCT00731822|Primary|Change From Baseline in Weighted Mean Heart Rate 0-4 Hours Post-dose at the End of the 28-day Treatment Period|Co-Primary Endpoint. Weighted mean was derived by calculating the average area under the curve (AUC), and then dividing by the relevant time interval. Baseline is the most recent result taken on or before pre-dose Day 1. Heart rate was recorded at 60 minutes (min) prior to dosing and at 15 min, 45 min, 90 min, 120 min, and 240 min post-dose on Day 28. Change from Baseline was calculated as the Day 28 value minus the Baseline value. Analysis was performed using a restricted maximum likelihood (REML)-based repeated measures mixed model approach (MMRM) with covariates of Baseline heart rate, sex, age, smoking status, treatment, and day and day by treatment and day by Baseline interactions. par.=participants.|Baseline to Day 28|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. The number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT Population without missing covariate information and with >=1 post-BL measurement are included in the analysis.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
1220580|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|12 month after enrollment|Modified intention to treat analysis|||Participants|||Number
1220581|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|6 month after enrollment|Modified intention to treat analysis|||Participants|||Number
1220584|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|12 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
1220585|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|6 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
1220586|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|3 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
1220587|NCT00731783|Primary|Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|1 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
1220588|NCT00731731|Secondary|Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II)|"The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing."|Up to 5 years||||participants evaluable for toxicity|||Number
1220589|NCT00731731|Secondary|Time to Tumor Progression (Phase II)|Progression free survival time will be defined from date of registration to date of progression or death.|Up to 5 years||||months||95% Confidence Interval|Median
1220590|NCT00731731|Secondary|Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade|Safety variables will be summarized by descriptive statistics. Adverse Events (AEs) that occur will be reported for each phase and dose level and described in terms of incidence and severity. Parameters will be described based on the CTC severity grading. Distribution by CTC severity grade and clinical relevance will be given.|Up to 5 years||||participants evaluable for toxicity|||Number
1220591|NCT00731731|Primary|Overall Survival at 15 Months (Phase II)|The primary endpoint will be survival status at 15 months (OS15). In addition, survival will be estimated using a Kaplan-Meier curve. For this analysis, patients who are still alive at the time of analysis have survival time censored at the last contact date.|Time from study registration to the date of death from any cause, assessed up to 5 years||||percentage of phase II patients||95% Confidence Interval|Number
1220592|NCT00731731|Primary|Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I)|"The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.~>~>~DLT will be defined as any of the following events occurring during treatment with vorinostat and temozolomide and attributable to one or both study drugs:~Grade 3 or 4 thrombocytopenia, grade 4 anemia or grade 4 neutropenia lasting > 7 days~Any non-hematologic grade 3 or greater adverse event, excluding alopecia and venous thromboembolism~Grade 4 radiation-induced skin changes~Failure to recover from toxicities to be eligible for re-treatment with vorinostat and temozolomide ≤ 14 days of the last dose of the two drugs"|10 weeks||||number of patients with DLT|||Number
1220593|NCT00731692|Secondary|Change in MSFC Z-score and Subscale Scores From Baseline to Month 36|The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.|Baseline to Month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS|||Z-scores||Standard Deviation|Mean
1220594|NCT00731692|Secondary|Blood Concentrations of Fingolimod and Fingolimod-phosphate|"Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.~Venous blood samples were collected for the analysis."|Month 3 up to 36 months|Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. (N). Only participants (n) who provided one or more evaluable blood concentration were included in the pharmacokinetic analysis population. Analysis include 147 patients (cohort 1)|||ng/ml||Standard Deviation|Mean
1220595|NCT00731692|Secondary|Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)|The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42*100).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1220865|NCT00729859|Secondary|Luteinizing Hormone Concentration (LH)||Baseline, Day 28|The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3.|||IU/L||Standard Deviation|Mean
1220596|NCT00731692|Secondary|Change From Baseline in European Quality of Life – 5 Dimensions (EQ-5D Score)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1220597|NCT00731692|Secondary|Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score|Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1220598|NCT00731692|Secondary|Change From Baseline in PRIMUS-Activities|The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1220599|NCT00731692|Secondary|Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)|The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1220600|NCT00731692|Secondary|Percent Change in Total T2 Lesion Volume From Baseline to Month 36|Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis|Baseline to month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percent Change||Standard Deviation|Mean
1220601|NCT00731692|Secondary|Number of Gd-enhancing Lesions at Month 36|Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis|Baseline to 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Gd-enhanced lesions per patient per scan||95% Confidence Interval|Least Squares Mean
1220602|NCT00731692|Secondary|Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36|Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis|Baseline to 36 months|Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||T2 Lesions per year||95% Confidence Interval|Least Squares Mean
1220603|NCT00731692|Secondary|Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.|The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants|||Number
1220604|NCT00731692|Secondary|Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentge of Participants|||Number
1220605|NCT00731692|Secondary|Percent Change From Baseline in Brain Volume at Month 36|The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.|Baseline to month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. N= Total number of patients included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1220694|NCT00730925|Secondary|Progression Free Survival (PFS) Time|PFS time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Weeks||95% Confidence Interval|Median
1220606|NCT00731692|Secondary|Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)|The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants||95% Confidence Interval|Number
1220607|NCT00731692|Primary|Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint|3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25’ TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25’ TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants||95% Confidence Interval|Number
1220608|NCT00731679|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.|||percentage of responders|||Number
1220609|NCT00731679|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.|||percentage of responders|||Number
1220610|NCT00731666|Secondary|The Rate of Change in Male Stress Urinary Incontinence(SUI).|"Subject responses to 3 questions were evaluated:~On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?~Overall, how often have you needed to change your daily activities because of urinary incontinence?~Overall, how big of a social problem has urinary incontinence been for you during the past month?"|12 months||||percentage of participants|||Number
1220611|NCT00731666|Secondary|Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.||12 and 24 months|Subjects implanted with Titan IPP|||percentage of participants|||Number
1220612|NCT00731666|Primary|The Study's Primary Objective Will Assess the Change in Penile Length.||12 months||||cm||Standard Deviation|Mean
1220613|NCT00731653|Primary|The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.||Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)|All patients who received at least one dose of study treatment during the extension phase were included in the analysis population. Analyses were performed with observed data. Tables and listings of safety and efficacy assessments will include all data observed. There was no imputation or adjustment for missing data values.|||participants|||Number
1220614|NCT00731640|Secondary|Spectacle Independence|The percentage of patients reporting spectacle independence (no longer needing to wear glasses).|6 Months||||Percentage of Participants|||Number
1220615|NCT00731640|Secondary|Patient Satisfaction|Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).|6 Months Postoperative||||Units on a Scale||Standard Deviation|Mean
1220616|NCT00731640|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 Months||||Log Units||Standard Deviation|Mean
1220617|NCT00731640|Primary|Visual Acuity|Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months||||LogMar||Standard Deviation|Mean
1220618|NCT00731614|Secondary|SF-12|the SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning.|Baseline, end of treatment, 12 weeks posttreatment, 24 weeks posttreatment||2015-06-30|06/2015||||
1220619|NCT00731614|Primary|Phantom Limb Pain Questionnaire|The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)|Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.|Data analyzed for participants with complete data for all assessments using repeated measure ANOVA.|||units on a scale||Standard Error|Mean
1220620|NCT00731549|Secondary|Percentage of Participants Who Discontinued Due to All Causes.|Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included.|||Percentage of participants|||Number
1220621|NCT00731549|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) Score.|To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 2, 4, 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
1220622|NCT00731549|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.|PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
1220623|NCT00731549|Secondary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.|To assess CGI-S, the rater or physician will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
1220624|NCT00731549|Secondary|Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
1220625|NCT00731549|Secondary|Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.|Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed had available assessments for evaluation of exacerbation of psychotic symptoms/impending relapse.|||Percentage of participants|||Number
1220626|NCT00731549|Secondary|Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.|"Stable was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here."|Baseline to Week 28|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.|||Percentage of participants|||Number
1220627|NCT00731549|Secondary|Percentage of Participants Achieving Remission.|Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.|Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.|||Percentage of participants|||Number
1220644|NCT00731133|Secondary|Proportion of Amphetamine-positive Urine Samples|the proportion of urine samples positive for amphetamine. Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|thrice weekly for 6 weeks|Only data from participants who received more than one dose of disulfiram were analyzed. Of the 15 participants who entered the study, one participant received only one dose so data from 14 participants were analyzed.|||proportion of urines positive for amphet||Standard Deviation|Least Squares Mean
1220695|NCT00730925|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
1220628|NCT00731549|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|"Impending relapse criteria was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage."|Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.|||Percentage of participants|||Number
1220629|NCT00731549|Primary|Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).|"Stable was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here."|Baseline to Week 52/Last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.|||Percentage of participants|||Number
1220630|NCT00731484|Primary|Tear Osmolarity in Human Measured by TearLab System|Tear osmolarity was measured with a laboratory-on-a-chip, which simultaneously collects and analyzes the electrical impedance of a 50 nL tear sample from the inferior lateral meniscus (TearLab Osmolarity System). The results are reported in mOsm/L. The trial was not set up to evaluate diagnostic performance, as no gold-standard method was used to establish dry eye status, but rather, to determine whether the TearLab could measure tear osmolarity in human subjects.|Single visit, at time of tear osmolarity testing.|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens Syndrome|||mOsms/L||Full Range|Mean
1220631|NCT00731341|Secondary|Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure|Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).|Post procedure||||Score from 1 to 5||Full Range|Mean
1220632|NCT00731341|Secondary|Evaluation of Length of an Average Cryoablation Procedure|Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids|Post procedure||||Minutes||Full Range|Mean
1220633|NCT00731341|Secondary|Number of Participants Discharged on Day of Cryoablation Procedure.|Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.|Post procedure||||Participants|||Number
1220634|NCT00731341|Secondary|Time (in Days) to Return to Normal Activity|The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.|4 weeks post procedure||||Days||Full Range|Mean
1220635|NCT00731341|Secondary|Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient|Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient|Prior to hospital discharge (less than 24 hours post-procedure)||||Units on a scale from 1 to 10||Full Range|Mean
1220636|NCT00731341|Primary|Number of Adverse Events|Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)|up to 4 weeks post procedure.||||Participants|||Number
1220637|NCT00731211|Secondary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months||||months||95% Confidence Interval|Median
1220638|NCT00731211|Primary|Overall Response Rate|Proportion of patients with complete and partial response (CR and PR). CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.|18 months||||percentage of patients||95% Confidence Interval|Number
1220639|NCT00731198|Secondary|Side Effects||Intra-procedure and 24 hours after ERCP|||||||
1220640|NCT00731198|Secondary|Frequency of Post-ERCP Complications||48 hours after ERCP|||||||
1220641|NCT00731198|Secondary|Percentage of Successful Selective Cannulation||Intra-procedure|||||||
1220642|NCT00731198|Secondary|Cannulation Time||Intra-procedure|||||||
1220643|NCT00731198|Primary|The Grades of the Number of Duodenal Contractions|a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.|Intra-procedure||||scores on a scale||Standard Deviation|Mean
1220692|NCT00730964|Primary|The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.|A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.|Within 24 hours post contrast administration||||Serious Adverse Reactions|||Number
1220645|NCT00731133|Primary|Side Effects Checklist|It consists of 25 items describing side effects specific to disulfiram alone or combined with alcohol or cocaine that are rated on a scale from 0 (not at all) to 4 (very much). Total scores range from 0 (minimum) to 100 (maximum). Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|Weekly for six weeks|Those who received more than one dose of disulfiram and/or completed more than one set of assessments during the protocol. Of the 15 participants who entered the study, one participant only attended clinic one day and so data were analyzed for 14 participants.|||units on a scale||Standard Deviation|Least Squares Mean
1220646|NCT00731120|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
1220647|NCT00731120|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means were from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Full analysis set with a Baseline SF-36 measurement; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1220648|NCT00731120|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1220649|NCT00731120|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1220650|NCT00731120|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model adjusting for Baseline score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220651|NCT00731120|Secondary|Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model adjusting for Baseline CGI-S score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220652|NCT00731120|Secondary|Percentage of Participants in HAM-A Remission at Week 8|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
1220653|NCT00731120|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as a participant with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
1220693|NCT00730925|Secondary|Summary of Pre-dose Concentrations of Afatnib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)|Day 15, 29 and 57|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1220654|NCT00731120|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220655|NCT00731120|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
1220656|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 12|Month 12||||meters||Standard Deviation|Mean
1220657|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 6|Month 6||||meters||Standard Deviation|Mean
1220658|NCT00731094|Secondary|Physical Function: 6-Minute Walking Distance (6MWD)|Physical Function: 6MWD in meters measured at Month 0|Month 0||||meters||Standard Deviation|Mean
1220659|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 12||||scores on a scale||Standard Deviation|Mean
1220660|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 6||||scores on a scale||Standard Deviation|Mean
1220661|NCT00731094|Secondary|HRQL: SF-36 Mental Component Summary Measure (MSC)|HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 0||||scores on a scale||Standard Deviation|Mean
1220662|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 12||||scores on a scale||Standard Deviation|Mean
1220663|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 6||||scores on a scale||Standard Deviation|Mean
1220866|NCT00729859|Secondary|Follicle Stimulating Hormone (FSH)||Baseline, 28 days|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||IU/L||Standard Deviation|Mean
1220664|NCT00731094|Secondary|Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)|HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 0||||scores on a scale||Standard Deviation|Mean
1220665|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
1220666|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
1220667|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
1220668|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
1220669|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
1220670|NCT00731094|Secondary|High-density Lipoprotein (HDL) Cholesterol|HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
1220671|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
1220672|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
1220673|NCT00731094|Secondary|Low-density Lipoprotein (LDL) Cholesterol|LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
1220674|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 12|Month 12||||mmHg||Standard Deviation|Mean
1220675|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 6|Month 6||||mmHg||Standard Deviation|Mean
1220676|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 0|Month 0||||mmHg||Standard Deviation|Mean
1220677|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 12|Month 12||||mmHg||Standard Deviation|Mean
1220678|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 6|Month 6||||mmHg||Standard Deviation|Mean
1220679|NCT00731094|Secondary|Systolic Blood Pressure (BP)|Systolic BP in millimeters of mercury (mmHg) measured at Month 0|Month 0||||mmHg||Standard Deviation|Mean
1220680|NCT00731094|Secondary|Weight|Weight in kilograms measured at Month 12|Month 12||||kg||Standard Deviation|Mean
1220681|NCT00731094|Secondary|Weight|Weight in kilograms at measured at Month 6|Month 6||||kg||Standard Deviation|Mean
1220682|NCT00731094|Secondary|Weight|Weight in kilograms (kg) measured at Month 0|Month 0||||kg||Standard Deviation|Mean
1220683|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12|Month 12||||participants|||Number
1220684|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6|Month 6||||participants|||Number
1220685|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0|Month 0||||participants|||Number
1220686|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire|Month 12||||participants|||Number
1220687|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire|Month 6||||participants|||Number
1220688|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire|Month 0||||participants|||Number
1220689|NCT00731055|Primary|Cigarette Choice|Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.|During each of the four weekly 6-hour experimental sessions||||number of cigarette choices (0-9)||Standard Deviation|Mean
1220690|NCT00731042|Primary|Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days|Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).|Baseline and 14 days|Analysis was done per protocol|||units on a scale||Standard Deviation|Mean
1220691|NCT00730964|Secondary|The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.|The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography.|Within 24 hours post contrast administration||||Serious adverse events|||Number
1220867|NCT00729859|Primary|Endothelial Progenitor Cells|Number of CD33 + CD134+ cells as a percentage of all lymphocytes|Baseline, Day 28|Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed|||percentage of all lymphocytes||Standard Deviation|Mean
1220696|NCT00730925|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
1220697|NCT00730912|Primary|Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.|||ng•hr/mL||Standard Deviation|Mean
1220698|NCT00730912|Primary|Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.|||ng/mL||Standard Deviation|Mean
1220699|NCT00730886|Secondary|Health Care Costs||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220700|NCT00730886|Secondary|Medical Outcomes Study 36-Item Short Form Survey||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220701|NCT00730886|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220702|NCT00730886|Secondary|Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220703|NCT00730886|Secondary|C-Section Rate||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220704|NCT00730886|Secondary|Time to Conception||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220705|NCT00730886|Secondary|Miscarriage Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220706|NCT00730886|Secondary|Term Delivery Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220707|NCT00730886|Secondary|Pregnancy Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220708|NCT00730886|Primary|Live Birth Rate||Between the 3 and 9-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1220709|NCT00730847|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.|During the entire study period (from Day 0 up to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.|||Participants|||Count of Participants
1220710|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.|||Participants|||Count of Participants
1220868|NCT00729846|Primary|Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.||1 Year||||percent of participants|||Number
1220711|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0°C.|During the 7-day follow-up period (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.|||Participants|||Count of Participants
1220712|NCT00730847|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.|||Participants|||Count of Participants
1220713|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redeness. Reflective ratings assessed the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM) and were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1220714|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of eye itching/burning, eye tearing/watering, and eye redness were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1220715|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redness. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM). The average of the AM and PM reflective individual ocular symptoms is the daily reflective individual ocular symptoms. Reflective individual ocular symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1220716|NCT00730756|Secondary|Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)|The Total Ocular Symptom Score (TOSS) is a sum (scale 0-9) of the individual ocular scores for eye itching/burning, eye tearing/watering, and eye redness. All 3 symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 2 (Severe). The daily reflective TOSS (daily rTOSS) is the average of the morning (AM) and evening (PM) rTOSS assessments that measure symptoms over the previous 12 hours. The AM pre-dose instantaneous (iTOSS) assessment is performed in the morning prior to dosing and evaluates symptoms at that moment, providing data on the duration of action of treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1220717|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip as measured in the morning and evening. Reflective rating represents the participant's symptoms over the preceding 12 hours. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1220718|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1220719|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed in the morning (AM) and evening (PM). The daily reflective individual nasal symptom score average of the AM and PM reflective individual nasal symptoms is the daily reflective individual nasal symptom score. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1220720|NCT00730756|Secondary|Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)|The TNSS is the Total Nasal Symptom Score (scale 0-9), a sum of the individual nasal scores for (1) rhinorrhea, (2) nasal congestion, and (3) post-nasal drip. All 3 symptoms were evaluated using a scale of: 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours (AM rTNSS, PM rTNSS). The AM pre-dose instantaneous assessment (AM pre-dose iTNSS) was performed in the morning just prior to dosing and assessed symptoms at that moment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1220781|NCT00730275|Secondary|Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||nM||95% Confidence Interval|Geometric Mean
1220721|NCT00730756|Primary|Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)|The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.|Baseline through Week 4 (28 days)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication|||points on a scale||Standard Error|Least Squares Mean
1220722|NCT00730730|Secondary|Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.|"Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI.~An ABI ≥ 0.90 is considered normal."|From baseline up to 30-days|Evaluable Ankle-brachial Index (ABI)/Toe brachial Index (TBI)result: missing data for 1 limb|||limbs|Participants||Number
1220723|NCT00730730|Secondary|Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.|"Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up-~Category 0: Asymptomatic, no hemodynamically significant occlusive disease;~Category 1: Mild claudication;~Category 2: Moderate claudication;~Category 3: Severe claudication;~Category 4: Ischemic rest pain;~Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia;~Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable"|From baseline up to 30-days|Analysis calculated using number of evaluable limbs with Rutherford results; data missing for two limbs|||limbs|Participants||Number
1220724|NCT00730730|Secondary|Number of Participants With Acute Success|angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)|from after stent placement to prior to hospital discharge (up to 3 days)|Intent to Treat population(ITT); missing angiographic data for one patient|||participants|||Number
1220725|NCT00730730|Primary|The Number of Participants With Major Adverse Events (MAE)|Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry|30 days|Intent-to-treat population (ITT)|||participants|||Number
1220726|NCT00730691|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
1220727|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 4 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220728|NCT00730691|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220729|NCT00730691|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1220737|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; Last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1240307|NCT00579670|Secondary|"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"||Week 12|FAS|||Participants|||Number
1220730|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220731|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1220732|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220733|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220734|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220735|NCT00730691|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1220736|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220748|NCT00730639|Secondary|Duration of Tumor Response|Duration of tumor response (DOR) was calculated from the first date of response of complete response (CR) or partial response (PR) to the date of the first progressive disease (PD) or the date of death. Duration of response was censored at the last tumor assessment date if a responder did not have PD or death. Nonresponders were not included in the analysis. Median DOR was estimated by Kaplan-Meier analysis.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with a measurable tumor response were analyzed.|||months||Full Range|Median
1220738|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220739|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220740|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220741|NCT00730691|Primary|Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1220742|NCT00730639|Secondary|Mean Effective Half-life (T-HALFeff)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of T-HALFeff was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||hours (h)||Standard Deviation|Mean
1220743|NCT00730639|Secondary|Geometric Mean Total Body Clearance of Drug From Serum (CLT)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples Blood samples were assessed at all doses from a subset of participants. The PK parameter of CLT was measured in milliliters per hour (mL/h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1220744|NCT00730639|Secondary|Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of AUC was measured in micrograms*hours per milliliter (μg*h/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||micrograms*hours per milliliter (μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1220745|NCT00730639|Secondary|Median Time of Maximum Serum Concentration (Tmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed Blood samples were assessed at all doses from a subset of participants. The PK parameter of Tmax was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||hours (h)||Full Range|Median
1220746|NCT00730639|Primary|Number of Participants With Abnormal Hematology Laboratory Values|Hemoglobin, Lymphocytes, Neutrophils, Platelets and Leukocytes. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for Hemoglobin were based on Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for Neutrophils were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0. Abnormal values for Leukocytes were based on Gr 1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.|||participants|||Number
1220747|NCT00730639|Secondary|Geometric Mean Maximum Serum Concentration (Cmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA). Blood samples were assessed at all doses from a subset of participants. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1220749|NCT00730639|Secondary|Objective Response Rate|Tumor response was evaluated by the sponsor based on tumor assessments by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate (ORR) was defined as the proportion of participants who's confirmed best overall response (BOR) is either complete (CR) or partial (PR), where the denominator is the number of treated participants in the population of interest. Response was based on tumor measurements. Responders= complete response (CR) or partial response (PR). CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. 95% Confidence intervals (CIs) were computed using the Clopper Pearson method.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with an evaluable tumor response were analyzed.|||percentage of participants||95% Confidence Interval|Number
1220750|NCT00730639|Secondary|Immunogenicity Assessment|Classification of participants host immune response was based on the following definitions: Anti-Drug Antibody (ADA) Positive Subjects have with at least one ADA positive sample at any time after initiation of treatment. ADA positive subjects were further classified into categories with Persistent Positive defined as an ADA positive sample at 2 or more sequential timepoints at least 8 weeks apart.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab and were ADA-evaluable were analyzed.|||participants|||Number
1220751|NCT00730639|Primary|Number of Participants With Abnormal Serum Chemistry Laboratory Values|Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine and Total Bilirubin. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.|||participants|||Number
1220752|NCT00730639|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||participants|||Number
1220753|NCT00730483|Secondary|Symptomatic Response by Assessing Symptom Severity in Patients|"Symptomatic response not assessed due to premature termination of study.~Scoring system for assessing symptom severity in patients with neuroendocrine/carcinoid syndrome was as follows:~- No symptoms - Patient completely asymptomatic~- Mild symptoms - Patient with symptoms of diarrhea, flushing, or asthma up to 4 times weekly~- Symptoms impact daily living - symptoms of diarrhea, flushing, or asthma up 5-7 weekly~- Severe symptoms - multiple daily symptoms of diarrhea, flushing, or asthma; symptoms require significant reorganization of daily activities~- Disabling symptoms - Patient disabled by multiple attacks and severe symptoms; unable to leave home or requires hospitalization"|Duration of study participation, average of 12 months|||||||
1220754|NCT00730483|Secondary|Biochemical Response - Time to Progression|Biochemical response not assessed due to premature termination of study.|Time to progression, 12 months|||||||
1220755|NCT00730483|Secondary|Survival|Survival outcomes not assessed due to premature termination of study.|overall survival|||||||
1220756|NCT00730483|Secondary|Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria|"Study was terminated and full outcome not assessed. The results below are based on 13 patients at 1 month post DEB-TACE, 10 patients at 6 months, and 6 patients at 12 months.~RECIST:~Complete Response (CR): Disappearance of all targeted lesions Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): At least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Cases that are not applicable for PD or PR.~EASL:~CR: Absence of any enhancement in target lesion PR: Greater than 50% decrease from baseline enhancement in target lesion PD: Greater than 25% increase in target lesion SD: All other cases"|12 months|13 patients were analyzed for 1 month post-treatment; 10 patients for 6 months post-treatment; and 6 patients at the 12 month post-treatment time point.|||Participants|||Count of Participants
1220757|NCT00730483|Primary|Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE|Safety was assessed at each DEB-TACE procedure and at every follow-up thereafter according to National Cancer Institute Common Toxicity Criteria (CTCAE) v3.0. The study was prematurely terminated due to high incidence of biloma and liver abscess. Safety data below is based off of 13 patients enrolled on protocol at 1 month post initial treatment.|1 month after initial DEB-TACE treatment||||number of adverse events|||Number
1220758|NCT00730405|Secondary|The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52|A count of the number of toenails affected, using visual examination, was performed at all study visits (Week 12, 24, 30, 36, 44 and 52). The investigator given a global evaluation of the toenails condition, based on the investigator’s assessment of the reduction in extent of nail involvement and improvement in clinical signs as compared with the status at the Baseline visit. The 0-5 rating scale was used: 0: cleared, 1: much improved, 2: minimally improved, 3: unchanged, 4: minimally worse and 5: much worse; where higher score indicates worse condition and lower score indicates clear toenail.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1220759|NCT00730405|Secondary|Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52|Length of the unaffected part of the target nail was measured in millimeters along the midpoint from the nail fold to the proximal border of the affected part (lowest point affected) along the midpoint of the target nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. Baseline values were the observations at Week 0/Day 1 or before. Change from Baseline was a Baseline value subtracted from Week 52 value. P-value was based on analysis of variance (ANOVA) with treatment and pooled center. Statistics is provided for adjusted least square mean.|Baseline (Week 0/Day 1 or before) and up to Week 52|ITT analysis set. All participants were available at the time of assessment.|||Millimeters||Standard Deviation|Mean
1220760|NCT00730405|Secondary|The Percentage of Participants Who Achieve Complete Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Complete cure was defined as mycological cure plus clinical cure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1220761|NCT00730405|Secondary|The Percentage of Participants Who Achieve Mycological Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Mycological cure was defined as negative potassium hydroxide (KOH) and negative cultures for dermatophytes. It was assessed on Week 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1220762|NCT00730405|Secondary|The Percentage of Participants Who Achieve Clinical Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Clinical cure was defined as 100% clear nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1220763|NCT00730405|Primary|The Percentage of Participants Who Achieve Effective Treatment at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|The intent-to-treat (ITT) analysis set consists of all randomized participants who receive study product. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1220764|NCT00730353|Secondary|Toxicity Profile|Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.|16 months||||instances of adverse event|||Number
1220765|NCT00730353|Secondary|Progression-Free Survival|To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.|12 months|Intention-to-treat patients|||Days||90% Confidence Interval|Median
1220766|NCT00730353|Secondary|Overall Survival|To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma|12 months|All participants on an intent-to-treat basis|||percentage of participants||90% Confidence Interval|Median
1220767|NCT00730353|Secondary|Response Rate|To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.|6 months|Evaluable patients, as previously defined.|||percentage of participants||90% Confidence Interval|Number
1220768|NCT00730353|Primary|Progression Free Survival Rate at 24 Weeks|To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|24 weeks|Intent to treat - all enrolled participants|||percentage of participants||90% Confidence Interval|Number
1220769|NCT00730327|Post-Hoc|Percent Total Body Weight Loss (%TBWL)|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).|||percentage of TBWL||95% Confidence Interval|Mean
1220770|NCT00730327|Post-Hoc|Percent EWL (Using BMI=25 kg/m²)|"Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).~Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)|||percentage of EWL||Standard Deviation|Mean
1220780|NCT00730275|Secondary|Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||hours||Full Range|Median
1220771|NCT00730327|Post-Hoc|Change in BMI|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).|||kg/m²||Standard Deviation|Mean
1220772|NCT00730327|Secondary|Change in Participant Depression (Beck Depression Inventory II)|Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)|||units on a scale||Standard Deviation|Mean
1220773|NCT00730327|Secondary|Change in Quality of Life (IWQOL-Lite)|The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints).|||units on a scale||Standard Deviation|Mean
1220774|NCT00730327|Secondary|Change in Quality of Life (SF-36)|The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.|Baseline, Week 39|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).|||units on a scale||Standard Deviation|Mean
1220775|NCT00730327|Secondary|Percent of Participants With Comorbid Conditions|"The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline.~Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL.~Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic.~Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female)."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).|||percentage of participants|||Number
1220776|NCT00730327|Primary|Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group|"The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group.~%EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight.~Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table."|9 months|Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).|||percentage of BIB participants||95% Confidence Interval|Number
1220777|NCT00730327|Primary|Mean Percent Excess Weight Loss (%EWL)|"The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint.~Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight."|9 months|Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).|||percentage of EWL||Standard Deviation|Mean
1220778|NCT00730275|Secondary|Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo|"Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose.~WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity."|Pre-dose through 24 hours post-dose|All participants who received a single dose of sitagliptin or placebo.|||Percent inhibition||95% Confidence Interval|Least Squares Mean
1220779|NCT00730275|Secondary|Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin|Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||hours||Standard Deviation|Mean
1220782|NCT00730275|Primary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin|Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||nM*hour||95% Confidence Interval|Geometric Mean
1220783|NCT00730275|Primary|Number of Participants Who Experienced at Least One Adverse Event||Pre-study through 10 to 14 days following administration of study drug|All enrolled participants.|||participants|||Number
1220784|NCT00730236|Secondary|Absolute Change From Baseline in Weight|Absolute change from Baseline in weight|Baseline and Week 78|All patients treated|||kg||Standard Deviation|Mean
1220785|NCT00730236|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and Week 78|All patients treated|||mg/dL||Standard Deviation|Mean
1220786|NCT00730236|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and Week 78|All patients treated|||U/L||Standard Deviation|Mean
1220787|NCT00730236|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and Week 78|All patients treated|||U/L||Standard Deviation|Mean
1220788|NCT00730236|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and Week 78|All patients treated|||Percent Hepatic Fat||Standard Deviation|Mean
1220789|NCT00730236|Secondary|Percent Change From Baseline in Apolipoprotein AI (Apo AI)|Percent change from Baseline in Apo AI|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1220790|NCT00730236|Secondary|Percent Change From Baseline in Non-HDL-C|Percent change from Baseline in non-HDL-C|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1220791|NCT00730236|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Percent change from Baseline in HDL-C|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Median
1220792|NCT00730236|Secondary|Percent Change From Baseline in Triglycerides|Percent change from Baseline in triglycerides|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1220793|NCT00730236|Secondary|Percent Change From Baseline for Apolipoprotein B (Apo B)|Percent change from Baseline for Apo B|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1220794|NCT00730236|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change from Baseline in TC|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1220795|NCT00730236|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline and Week 26|Intention To Treat (ITT) Population|||Percent Change||Standard Deviation|Mean
1220796|NCT00730171|Primary|Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)|For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug.|From first dose of open-label study drug up to 78 weeks|Enrolled participants who received at least 1 dose of open-label study drug. It was identified that 1 participant enrolled twice in the study under 2 ID numbers; this participant is included as an RI participant in the CC Safety Population, and as an RO participant in both the IBS-C and Overall Safety Populations.|||Participants|||Count of Participants
1220797|NCT00730132|Primary|Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||mmol/L||Standard Deviation|Mean
1220798|NCT00730132|Primary|Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||mmol/L||Standard Deviation|Mean
1220799|NCT00730132|Primary|Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation||Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded.|||Percentage of patients|||Number
1220800|NCT00730132|Primary|Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation|Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||Percentage of patients|||Number
1220801|NCT00730132|Primary|Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin.|Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|During the study|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol violations were recorded. One subject each from ezetimibe added to existing statin and new statin group were excluded (missing data)|||Percentage of patients|||Number
1220802|NCT00730041|Secondary|Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)|The CPAP machine has an internal clock/calendar, and capabilities to record usage onto a removable data card the size of a credit card. Data is recorded from the first time the machine is turned on to the last time the machine is turned on during a given period in which the SmartCard is present in the machine. The SmartCard records all days during the given period and keeps track of days in which the CPAP machine is used and days in which it is not used. The SmartCard data is able to be downloaded to a computer for review and analysis.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.|||Average hours per day of days used||Standard Deviation|Mean
1220803|NCT00730041|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.|The FOSQ can assess the quality of sleep and this scale is a validated measure the impact of excessive sleepiness on multiple activities of daily living. It has 30 questions in 5 subgroups of general productivity (8 questions), social outcome (2), activity level (9), vigilance (7), and intimate relationships and sexual activity (4). Responses for each question range from 1 (extreme difficulty or low activity level) to 4 (no difficulty or high activity level) for each subgroup. A mean is calculated for each subgroup, and then the mean of the subgroups is calculated and multiplied by 5.|Baseline and 4 months post-procedure|Two subjects became lost to follow-up and did not return for the final study visit.|||Scores on a Scale||Standard Deviation|Mean
1220804|NCT00730041|Secondary|Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.|The Epworth Sleepiness Scale (ESS) was included in the subject questionnaire as a tool to further assess the quality of sleep for each subject throughout the follow-up period. This scale is a validated clinical indicator that quantifies the patient’s chance of falling asleep during eight different activities of daily living such as reading, talking, resting and driving. Each of the eight questions has four possible responses: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing to 3 = high chance of dozing, for a possible maximum score of 24.|Baseline and 4 months post-procedure|Two participants became lost to follow-up and did not return for the final study visit.|||Scores on a Scale||Standard Deviation|Mean
1220805|NCT00730041|Secondary|Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP satisfaction. Scores ranged from 0 (very unsatisfied) to 10 (very satisfied).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.|||Scores on a Scale||Standard Deviation|Mean
1220806|NCT00730041|Secondary|Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)|Leak is an indicator of mask/headgear fit and can also be used to substantiate or contradict an assigned therapeutic pressure. Total leak is the sum of intentional leak to prevent carbon dioxide rebreathing and unintentional leak. Each mask has a known amount of leak (the intentional leak), and subjects were instructed not to changes masks to minimize this variable. Approximate range is 0-100, and the amount of leak increases as the number increases. Average leak values are in the 20-50 liters per minute range. The CPAP machine records leak data during each night of usage and can average.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.|||Units on a scale||Standard Deviation|Mean
1220807|NCT00730041|Secondary|Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP therapy comfort. Scores ranged from 0 (very uncomfortable) to 10 (very comfortable).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.|||Scores on a Scale||Standard Deviation|Mean
1220808|NCT00730041|Primary|Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration|The American Academy of Sleep Medicine’s (AASM) recommended treatment for patients with obstructive sleep apnea (OSA) is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to prevent collapse of the upper airway. CPAP pressures are measured in centimeters of water, and range in whole numbers from 4cm H2O to 20cm H2O. The therapeutic pressure is usually determined during overnight polysomnography and usually performed by a technician.|Baseline and 3 months post-procedure|50 of 51 total participants returned to the sleep lab for the 90-day PSG. All 50 participants are part of the primary endpoint analysis.|||centimeters of water (cm H2O)||Standard Deviation|Mean
1220809|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|All participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
1220820|NCT00730015|Secondary|12-week Change in Severity of Straining|"Severity of Straining is measured on a 5-point scale, where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1220810|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit.|||percentage of participants||95% Confidence Interval|Number
1220811|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|All participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
1220812|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit.|||percentage of participants||95% Confidence Interval|Number
1220813|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.|"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The ITT population was comprised of all participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
1220814|NCT00730028|Secondary|Number of Participants Reporting Adverse Events That Are Treatment Limiting.|Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.|||participants|||Number
1220815|NCT00730028|Secondary|Number of Participants Reporting Adverse Events.|Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.|||participants|||Number
1220816|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.|"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit.|||percentage of participants||95% Confidence Interval|Number
1220817|NCT00730015|Secondary|12-week Change in Constipation Severity|"Constipation severity was based on a 5-point ordinal scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 10 patients who dropped out prior to finishing 1 week of the trial have missing data. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1220818|NCT00730015|Secondary|12-week Change in Bloating|"Bloating was based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1220819|NCT00730015|Secondary|12-week Change in Abdominal Discomfort|"Abdominal discomfort is based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1220859|NCT00729859|Secondary|Fasting Serum Insulin||Baseline, Day 28, Day 56|per protocol|||picomolar||Standard Deviation|Mean
1220821|NCT00730015|Secondary|12-week Change in Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1220822|NCT00730015|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The number of SBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||SBMs per Week||Standard Error|Least Squares Mean
1220823|NCT00730015|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The number of CSBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||CSBMs per Week||Standard Error|Least Squares Mean
1220824|NCT00730015|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1220825|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220826|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220827|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.|||days||Standard Deviation|Mean
1220828|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||days||Standard Deviation|Mean
1220829|NCT00729937|Secondary|Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class|All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220830|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220860|NCT00729859|Secondary|Homeostasis Model of Insulin Resistance (HOMA-IR)|HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol|||HOMA score||Standard Deviation|Mean
1220861|NCT00729859|Secondary|Quantitative Insulin Sensitivity Check Index (QUICKI)|QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol|||QUICKI index||Standard Deviation|Mean
1220831|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220832|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220833|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220834|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220835|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220836|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220837|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220838|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220839|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220840|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220862|NCT00729859|Secondary|Sex Hormone Binding Globulin (SHBG)||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||nmol/L||Standard Deviation|Mean
1220863|NCT00729859|Secondary|Estradiol Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||pmol/L||Standard Deviation|Mean
1220841|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220842|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220843|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220844|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220845|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220846|NCT00729937|Secondary|Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220847|NCT00729937|Secondary|Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220848|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220864|NCT00729859|Secondary|Testosterone Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3.|||nmol/L||Standard Deviation|Mean
1220928|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)||12 weeks|ITT; LOCF|||percentage of parabasal cells||Standard Deviation|Mean
1220849|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220850|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220851|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220852|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220853|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220854|NCT00729937|Primary|Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1220855|NCT00729937|Secondary|Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1220856|NCT00729924|Secondary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.|This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).|Day 7||||ratio||Inter-Quartile Range|Median
1220857|NCT00729924|Primary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.|The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL).|Day 7||||1/h||Inter-Quartile Range|Median
1220858|NCT00729859|Secondary|Fasting Lipid Levels||Baseline, Day 28, Day 56|per protocol|||mmol/L||Standard Deviation|Mean
1220869|NCT00729833|Secondary|Number of Participants With Objective Response (OR)|Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1220870|NCT00729833|Secondary|Number of Participants With Anti-Drug Antibodies (ADA)|Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.|0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)|ADA Analysis Set: Participants who started treatment with study medication and provided at least 1 on-study ADA sample. Due to early termination of the study, ADA samples were not assayed.||||||
1220871|NCT00729833|Secondary|Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib||24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1220872|NCT00729833|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib||0.5 hour predose on Day 1 of Cycle 2|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1220873|NCT00729833|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib|AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).|0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1220874|NCT00729833|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||hours||Full Range|Median
1220875|NCT00729833|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1220876|NCT00729833|Secondary|Plasma Decay Half-Life (t1/2) of Figitumumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||hours||Standard Deviation|Mean
1220877|NCT00729833|Secondary|Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab|AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1220878|NCT00729833|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||milligram*hour/milliliter (mg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1220879|NCT00729833|Secondary|Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab||0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4|Pharmacokinetic (PK) Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||milligram/liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
1220880|NCT00729833|Secondary|Percentage of Participants With Blood Chemistry Laboratory Test Abnormality|Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication; n=number of participants evaluable for this outcome measure, respectively.|||percentage of participants|||Number
1220881|NCT00729833|Secondary|Percentage of Participants With Hematologic Laboratory Test Abnormality|Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1220929|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||12 weeks|ITT; LOCF|||participants|||Number
1220882|NCT00729833|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1220883|NCT00729833|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|"Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (>=) 7 days delay in administration of Cycle 2.~Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Baseline up to the end of Cycle 1 (each cycle=3 weeks)|Per-Protocol Analysis Set: All participants who started treatment and who did not have first cycle major treatment deviations.|||participants|||Number
1220884|NCT00729807|Secondary|Progression Time in Patients|To observe the time to progression in these patients. However, in the six patients treated they either all had progression of disease or stable when they came off study (i.e., the drug did not work, there was no basis to collect the data to time to progression (they went on to different treatments or hospice.) One patient was inevaluable due to going on hospice, four had disease progression disease and one had stable disease and patients must come off per protocol if they do not show a response to the drug.|pre- to post-treatment||2017-04-30|04/2017||||
1220885|NCT00729807|Secondary|Pre- and Post-treatment Changes in the Concentration of S100B and p21 in Tumor Biopsy Samples|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotension and hypoglycemia in the small cohort of patients actuallyly treated.|pre- and pos-treatment||2017-04-30|04/2017||||
1220886|NCT00729807|Secondary|Serial Serum S100B Levels|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotension and hypoglycemia in the small cohort of patients actually treated.|Days 3, 8, and 12 of Cycles 1 and 2||2017-04-30|04/2017||||
1220887|NCT00729807|Secondary|Wild-type p53 and S100B Status at Baseline|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotensions and hypoglycemia in the small cohort of patients actually treated.|Baseline||2017-04-30|04/2017||||
1220888|NCT00729807|Primary|CR, PR, Stable Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum of the longest diameter since the treatment started. (Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, J., Van Glabbeke, M., van Oosterom, A.T., Christian, M.C., Gwyther, S.G. (2000) J Natl Cancer Inst 92, 205-16)|Every 6-8 weeks||||participants|||Number
1220889|NCT00729781|Primary|Safety|Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.|During 12-week original study and at long-term follow-up of 11 months or longer|All enrolled subjects' adverse events were collected.|||events|||Number
1220890|NCT00729781|Primary|Cosmetic Improvement|"An independent clinician will review Vectra 3D photographs of each subject at baseline and at 12 weeks post-procedure to assess physical appearance of the external nasal wall. The clinician will be asked to determine which photographs are pre-treatment and which are post-treatment in the correct order. The clinician will then rate the photograph chosen as post-treatment using the Global Aesthetic Improvement Scale (GAIS; relative scale from Worse to Very much improved). If the post-treatment photograph was not correctly identified, that procedure will receive a “worse” on the rating scale."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.|||participants|||Number
1220891|NCT00729781|Primary|Functional Improvement|"Functional improvement was defined as a subject who achieves both 1) an improvement in the physical condition of the collapsed nasal valve as evidenced by an increase of >= 10% in the change in volume during inspiration as measured by Vectra 3D photography from baseline to 12 weeks post-procedure; and 2) a reduction of at least 30% in the symptoms of nasal obstruction as measured by the Nasal Obstruction Symptom Evaluation Scale (NOSE) scale (5 questions with 0-4 scale from Not a problem to Severe problem, possible score 0-100 via raw score × 5) from baseline to 12 weeks post-procedure."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.|||participants|||Number
1220892|NCT00729690|Secondary|Passive Knee Flexion|Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion).|PostOp day 2|All Completed Patients were used|||Degrees||Standard Deviation|Mean
1220930|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
1220893|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 12 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|12 hours Post dose|All Completed Patients|||Area (NRS*hr)||Standard Deviation|Mean
1220894|NCT00729690|Secondary|Active Knee Flexion|The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2|PostOp day 2|All completed patients used.|||Degrees||Standard Deviation|Mean
1220895|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 24 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|24 hours|All Completed Patients were included in the analysis.|||Area (NRS*hr)||Standard Deviation|Mean
1220896|NCT00729677|Post-Hoc|Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy|Number of participants on 2-drug (5HT3 inhibitor plus steroid) versus 3 drug (2-drug regimen plus an NK-1 inhibitor) who reported nausea during the first cycle of chemotherapy. 5HT-3 inhibitors included ondansetron, dolasetron, granisetron, and palonosetron. The NK-1 inhibitor was aprepitant. The steroid was dexamethasone.|Week 1||||participants|||Number
1220897|NCT00729677|Primary|Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy|Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy|week 1||||participants|||Number
1220898|NCT00729677|Primary|Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index – Emesis Scale at 5-7 Days|Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.|Week 1|this data was not collected||||||
1220899|NCT00729677|Primary|Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy||Week 1 of FOLFOX chemotherapy||||percentage of participants|||Number
1220900|NCT00729651|Post-Hoc|Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||ng/ml||Standard Deviation|Mean
1220901|NCT00729651|Post-Hoc|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||participants|||Number
1220902|NCT00729651|Secondary|Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment||Baseline and 16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||Percentage Change Serum PTH||95% Confidence Interval|Least Squares Mean
1220903|NCT00729651|Primary|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||participants|||Number
1220904|NCT00729612|Secondary|Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0|The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics|Up to 5 years|Grade 3 and 4|||patients|||Number
1220905|NCT00729612|Secondary|Overall Survival|Will be analyzed using a Kaplan-Meier methods.|Up to 5 years||||months||95% Confidence Interval|Median
1220906|NCT00729612|Secondary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 5 years||||months||95% Confidence Interval|Median
1220907|NCT00729612|Primary|Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.|Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
1220908|NCT00729586|Other Pre-specified|Number of Participants and Their Levels of Expression of the Candidate Markers|The levels of expression of the candidate markers measured prior to study treatment are tabulated. The expressions being tabulated include immunohistochemical expression of hormone receptors. The hormone receptors are estrogen receptor positive, progesterone receptors-A, progesterone receptor-B, PAKT Positive and PTEN Positive. The associations between the immunohistochemical expression of these biomarkers and between these biomarkers and treatment, outcome or clinical characteristics are reported for future investigation.|Baseline|Eligible and treated patients with primary tumor specimen|||participants|||Number
1220909|NCT00729586|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment.|Eligible and treated patients|||Participants|||Count of Participants
1220931|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
1220932|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)||12 weeks|ITT; LOCF|||pH||Standard Deviation|Mean
1220910|NCT00729586|Secondary|Duration of Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions.|Radiologic tumor evaluations at baseline and every six weeks for the first 24 weeks and then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.|Eligible and treated patients|||months||95% Confidence Interval|Median
1220911|NCT00729586|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every 6 weeks during treatment, then every 3 months for one year.|Eligible and treated patients|||months||95% Confidence Interval|Median
1220912|NCT00729586|Primary|Percentage of Participants With a Confirmed Objective Tumor Response Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Radiologic tumor evaluations at baseline and every 6 weeks for the first 24 weeks; then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.|Eligible and treated patients|||percentage of participants||94% Confidence Interval|Number
1220913|NCT00729560|Primary|DCI-IPG Measurements in Blood and Urine|zero participants analyzed, no assays performed|2 years|||||||
1220914|NCT00729521|Primary|Emergency Department and In-patient Hospitalization for Fall Injury|Rates of fall injury diagnoses per 100 person-years (P-Y) were computed for the communities in each of the study groups for a 2 year baseline period, 2007-2008, and for a 2 year follow-up period corresponding to years 2010-2011. Change in fall injury rates and their 95% confidence intervals (CI) are reported. A mixed-effects Poisson regression model was used to test the presence of an interaction effect on the fall rate between study group and time period (baseline or follow-up). The test is intended to detect a differential time effect by study group. This model, with main effects for study group and time period and an interaction term, will be referred to as the primary model. Model coefficients and incidence rate ratios (IRR) with 95% confidence intervals (CI) are reported.|2007-2008; 2010-2011|Population of residents aged 65 and older for participating communities in each study arm for 2007-2008 baseline period and 2010-2011 follow-up period.|||Fall Injury Rate per 100 person years||95% Confidence Interval|Number
1220915|NCT00729482|Secondary|Number of Participants With Adverse Events|(according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)|up to 24 weeks||||participants|||Number
1220916|NCT00729482|Secondary|Overall Survival||1 year||||Months||95% Confidence Interval|Median
1220917|NCT00729482|Secondary|Response Rate|Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.|2years|51 patients were available for response assessments.|||percentage of participants|||Number
1220918|NCT00729482|Primary|Progression-free Survival Rate at 4-month (16 Weeks)|progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion|4 months (16 weeks)||||percentage of participants|||Number
1220919|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
1220920|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
1220921|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group.|||participants|||Number
1220922|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)||4 weeks|ITT|||pH||Standard Deviation|Mean
1220923|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group.|||participants|||Number
1220924|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)||4 weeks|ITT|||pH||Standard Deviation|Mean
1220925|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||12 weeks|ITT; LOCF|||participants|||Number
1220926|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)||12 weeks|ITT; LOCF|||pH||Standard Deviation|Mean
1220927|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)||12 weeks|ITT; LOCF|||percentage of superficial cells||Standard Deviation|Mean
1220935|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Infarct Size|Measured as change in infarct size from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
1220936|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction|Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
1220937|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis|Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
1220938|NCT00729430|Primary|Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling|Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)|Before and after study treatments||||Percent Change||Standard Deviation|Mean
1220939|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Tibia 66% Site|Baseline to 24-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1220940|NCT00729378|Primary|24-month Change in Cortical Thickness at the Tibia 66% Site|Baseline to 24-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220941|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 66% Site|Baseline to 24-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220942|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220943|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220944|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 66% Site|Baseline to 24-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220945|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Tibia 50% Site|Baseline to 24-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1220946|NCT00729378|Primary|24-month Change in Cortical Thickness at the Tibia 50% Site|Baseline to 24-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1221192|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Size|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Error|Least Squares Mean
1220947|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 50% Site|Baseline to 24-month measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220948|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220949|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220950|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 50% Site|Baseline to 24-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220951|NCT00729378|Primary|24-month Change in Bone Strength Index at the Tibia 4% Site|Baseline to 24-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
1220952|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 4% Site|Baseline to 24-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220953|NCT00729378|Primary|24-month Change in Cortical Bone Area at the Tibia 4% Site|Baseline to 24-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1220954|NCT00729378|Primary|24-month Change in Trabecular Bone Area at the Tibia 4% Site|Baseline to 24-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1220955|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220956|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221193|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1220957|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 4% Site|Baseline to 24-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220958|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Femur 20% Site|Baseline to 24-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1220959|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Femur 20% Site|Baseline to 24-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220960|NCT00729378|Primary|24-month Change in Thickness of Cortical Bone at the Femur 20% Site|Baseline to 24-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220961|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220962|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220963|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Femur 20% Site|Baseline to 24-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220964|NCT00729378|Primary|24-month Change in Bone Strength Index at the Femur 4% Site|Baseline to 24-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
1220965|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Femur 4% Site|Baseline to 24-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220966|NCT00729378|Primary|24-month Change in Cortical Bone Area at the Femur 4% Site|Baseline to 24-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1221194|NCT00727857|Secondary|Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration|The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
1220967|NCT00729378|Primary|24-month Change in Trabecular Bone Area at the Femur 4% Site|Baseline to 24-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1220968|NCT00729378|Primary|24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220969|NCT00729378|Primary|24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220970|NCT00729378|Primary|24-month in Change in Total Volumetric Bone Density the Femur 4% Site|Baseline to 24-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units mg/ccm.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220971|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Tibia 66% Site|Baseline to 12-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1220972|NCT00729378|Primary|12-month Change in Cortical Thickness at the Tibia 66% Site|Baseline to 12-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220973|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 66% Site|Baseline to 12-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220974|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220975|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220976|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 66% Site|Baseline to 12-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221199|NCT00727857|Secondary|Change From Baseline in Very Small Low Density Lipoprotein Concentration|The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1220977|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Tibia 50% Site|Baseline to 12-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1220978|NCT00729378|Primary|12-month Change in Cortical Thickness at the Tibia 50% Site|Baseline to 12-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220979|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 50% Site|Baseline to 12-month change in periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220980|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220981|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220982|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 50% Site|Baseline to 12-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220983|NCT00729378|Primary|12-month Change in Bone Strength Index at the Tibia 4% Site|Baseline to 12-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
1220984|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 4% Site|Baseline to 12-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220985|NCT00729378|Primary|12-month Change in Cortical Bone Area at the Tibia 4% Site|Baseline to 12-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1220986|NCT00729378|Primary|12-month Change in Trabecular Bone Area at the Tibia 4% Site|Baseline to 12-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1221195|NCT00727857|Secondary|Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration|The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
1220987|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220988|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220989|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 4% Site|Baseline to 12-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220990|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Femur 20% Site|Baseline to 12-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1220991|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Femur 20% Site|Baseline to 12-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220992|NCT00729378|Primary|12-month Change in Thickness of Cortical Bone at the Femur 20% Site|Baseline to 12-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220993|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220994|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220995|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Femur 20% Site|Baseline to 12-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1220996|NCT00729378|Primary|12-month Change in Bone Strength Index at the Femur 4% Site|Baseline to 12-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
1221221|NCT00727714|Secondary|Changes in FeNO Measurements During One Shift (6-8h)||baseline and 6-8h|Problems With the FeNO (NIOX) device lead to few (58) included in FeNO measurements|||ppb||Full Range|Median
1220997|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Femur 4% Site|Baseline to 12-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1220998|NCT00729378|Primary|12-month Change in Cortical Bone Area at the Femur 4% Site|Baseline to 12-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1220999|NCT00729378|Primary|12-month Change in Trabecular Bone Area at the Femur 4% Site|Baseline to 12-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1221000|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221001|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221002|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density the Femur 4% Site|Baseline to 12-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221003|NCT00729378|Primary|Baseline Stress-Strain Index at the Tibia 66% Site|Baseline (initial) measurement of strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
1221004|NCT00729378|Primary|Baseline Cortical Thickness at the Tibia 66% Site|Baseline (initial) measurement of cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1221005|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 66% Site|Baseline (initial) measurement of periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1221006|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221007|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221196|NCT00727857|Secondary|Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration|The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
1221008|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 66% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221009|NCT00729378|Primary|Baseline Stress-Strain Index at the Tibia 50% Site|Baseline (initial) measurement of stress-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
1221010|NCT00729378|Primary|Baseline Cortical Thickness at the Tibia 50% Site|Baseline (initial) measurement of cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1221011|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 50% Site|Baseline (initial) measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1221012|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221013|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221014|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 50% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221015|NCT00729378|Primary|Baseline Bone Strength Index at the Tibia 4% Site|Baseline (initial) measurement of bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^4||Standard Deviation|Mean
1221016|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 4% Site|Baseline (initial) measurement of periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1221017|NCT00729378|Primary|Baseline Cortical Bone Area at the Tibia 4% Site|Baseline (initial) measurement of cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
1221018|NCT00729378|Primary|Baseline Trabecular Bone Area at the Tibia 4% Site|Baseline (initial) measurement of trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
1221019|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221197|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Size|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Error|Least Squares Mean
1221020|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 4% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221021|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221022|NCT00729378|Primary|Baseline Stress-Strain Index at the Femur 20% Site|Baseline (initial) measurement of stress-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
1221023|NCT00729378|Primary|Baseline Cortical Thickness at the Femur 20% Site|Baseline (initial) measurement of cortical thickness at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1221024|NCT00729378|Primary|Baseline Periosteal Circumference at the Femur 20% Site|Baseline (initial) measurement of periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1221025|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221026|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221027|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Femur 20% Site|Baseline (initial) measurement of total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221028|NCT00729378|Primary|Baseline Bone Strength Index at the Femur 4% Site|Baseline (initial) measurement of bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^4||Standard Deviation|Mean
1221029|NCT00729378|Primary|Baseline Periosteal Circumference at the Femur 4% Site|Baseline (initial) measurement of periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1221030|NCT00729378|Primary|Baseline Cortical Bone Area at the Femur 4% Site|Baseline (initial) measurement of cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
1221031|NCT00729378|Primary|Baseline Trabecular Bone Area at the Femur 4% Site|Baseline (initial) measurement of trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
1221198|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Concentration|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
1221032|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221033|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221034|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Femur 4% Site|Baseline (initial) measurement of total volumetric bone density at the femur 4% site. Measurement made by peripheral quantitative computed tomography (pQCT) at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1221035|NCT00729365|Secondary|We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.||year 1, 3, 5 and after the washout phase (5years and 1month)|||||||
1221036|NCT00729365|Primary|Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.||at 3months and then every 6months during the 5years of the study|||||||
1221037|NCT00729326|Secondary|Episodes of Hypoglycemia (Overall)|Number of episodes of hypoglycemia experienced overall during the study|4 weeks and 8 weeks|All patients in FAS|||episodes of hypoglycemia|||Number
1221038|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Overall)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 weeks and 8 weeks|All patients in FAS|||Percentage of patients|||Number
1221039|NCT00729326|Secondary|Episodes of Hypoglycemia (Week 4 to Week 8)|Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study|8 weeks|All patients in FAS|||episodes of hypoglycemia|||Number
1221040|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|8 weeks|All patients in FAS|||Percentage of patients|||Number
1221041|NCT00729326|Secondary|Episodes of Hypoglycemia (Baseline to Week 4)|Number of episodes of hypoglycemia experienced during the first 4 weeks of the study|4 weeks|Full analysis set|||episodes of hypoglycemia|||Number
1221042|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 Weeks|All patients in FAS|||Percentage of patients|||Number
1221043|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal|Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1221044|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC After the Morning Meal|Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1221045|NCT00729326|Secondary|Change in Postprandial Insulin AUC Excursion After the Morning Meal|Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1221046|NCT00729326|Secondary|Change in Postprandial Insulin AUC After the Morning Meal|Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1221047|NCT00729326|Secondary|Change in Postprandial C-peptide AUC Excursion After the Morning Meal|Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||nmol*hours/L||Standard Error|Least Squares Mean
1221048|NCT00729326|Secondary|Change in Postprandial C-peptide AUC After the Morning Meal|Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||nmol*hours/L||Standard Error|Least Squares Mean
1221049|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC Excursion After the Morning Meal|Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||mg*hours/dL||Standard Error|Least Squares Mean
1221050|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC After the Morning Meal|Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||mg*hours/dL||Standard Error|Least Squares Mean
1221051|NCT00729326|Secondary|Change in Postprandial Glucagon AUC Excursion After the Morning Meal|Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1221052|NCT00729326|Secondary|Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal|Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1221053|NCT00729326|Secondary|Change in Fasting Blood Glucose After the Morning Meal|Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward|||mg/dL||Standard Error|Least Squares Mean
1221054|NCT00729326|Secondary|Change in Two-hour Postprandial Glucose After the Morning Meal|Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward|||mg/dL||Standard Error|Least Squares Mean
1221055|NCT00729326|Primary|Change in Time-averaged Glucose During a 24 Hour Period|Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).|baseline and 8 Weeks|The number of patients was determined based on 90% powering of the study. Analyses were based on data from all randomized patients receiving at least one dose of the study drug and completing at least one treatment period. For each patient, the missing data for some time points were imputed by linear interpolation.|||mg/dL||Standard Error|Least Squares Mean
1221056|NCT00729248|Primary|CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors|CD4+CD25 high FOXP3+ cell levels in mixed lymphocyte reactions (MLRs) of Renal Pre-transplant Recipients/Donors were measured in the presence of 1) No Drug/Control; 2) 0.05-0.2, 0.3-3 and > 5 ng/ml Tacrolimus (TAC); OR 3) 0.05-0.2, 0.3-3 and > 5 ng/ml Sirolimus (SRL). CD4+CD25 high FOXP3+ cell levels in the MLRs with TAC or SRL are expressed as the percentage of CD4+CD25 high FOXP3+ cell levels in the MLRs with no drug.|3 months|For each arm, blood samples from 5 donor/recipient pairs (i.e., 10 participants) were used.|||Percentage of Control Cells||Standard Deviation|Mean
1221057|NCT00729183|Secondary|Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level|s-P1NP is a biochemical marker index of bone formation. s-P1NP was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. s-P1NP was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.|Baseline, 12 months, 24 months|PP population: All participants receiving at least one dose of study treatment and with available s-P1NP data, excluding participants with important deviations from the protocol that may have substantially affected the results.|||percent change||95% Confidence Interval|Least Squares Mean
1221058|NCT00729183|Secondary|Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level|s-CTx is a biochemical marker index of bone resorption. s-CTx was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. S-CTx was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.|Baseline, 12 months, 24 months|Per-Protocol (PP) population: All participants receiving at least one dose of study treatment and with available s-CTx data, excluding participants with important deviations from the protocol that may have substantially affected the results.|||percent change||95% Confidence Interval|Least Squares Mean
1221059|NCT00729183|Secondary|Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)|Trabecular vBMD at the lumbar spine (L2) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L2) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L2) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L2) baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221089|NCT00728988|Primary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)|Percentage calculated as: (number of participants who experienced MACE [death, myocardial infarction, target vessel revascularization] within 30 days post-PCI) divided by (number of participants who experienced PCI) * 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded.|30 days post PCI|Full Analysis Set (FAS): all participants who received at least one dose of study medication and received percutaneous coronary intervention (PCI). Last observation carried forward (LOCF).|||percentage of participants|||Number
1221060|NCT00729183|Secondary|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)|Trabecular vBMD at the lumbar spine (L1) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L1) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L1) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L1) baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221061|NCT00729183|Secondary|Percent Change From Baseline in Distal Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the one-third distal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the distal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization distal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having distal radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221062|NCT00729183|Secondary|Percent Change From Baseline in Ultradistal Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the ultradistal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the ultradistal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization ultradistal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having ultradistal radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221063|NCT00729183|Secondary|Percent Change From Baseline in Total Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the total radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total radius aBMD endpoint data subsequent to at least one dose of study treatment, and having total radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221064|NCT00729183|Secondary|Percent Change From Baseline in Hip Trochanter aBMD|aBMD (g/cm^2) data was measured by DXA at the hip trochanter. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the hip trochanter was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization hip trochanter aBMD endpoint data subsequent to at least one dose of study treatment, and having hip trochanter aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221065|NCT00729183|Secondary|Percent Change From Baseline in Femoral Neck aBMD|aBMD (g/cm^2) data was measured by DXA at the femoral neck (hip). All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the femoral neck was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization femoral neck aBMD endpoint data subsequent to at least one dose of study treatment, and having femoral neck aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221066|NCT00729183|Secondary|Percent Change From Baseline in Total Hip aBMD|aBMD (g/cm^2) data was measured by DXA at the total hip. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total hip was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total hip aBMD endpoint data subsequent to at least one dose of study treatment, and having total hip aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221090|NCT00728962|Secondary|Crestal Bone Regression||four years|||||||
1221067|NCT00729183|Secondary|Percent Change From Baseline to Month 24 in Lumbar Spine aBMD|aBMD (g/cm^2) was measured by DXA at the lumbar spine and mean BMD measurements from at least 3 evaluable vertebrae from L1 through L4 were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.|Baseline, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 24 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1221068|NCT00729183|Primary|Percentage of Participants That Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that discontinued study treatment (different from discontinuation of the study) due to an AE was reported for each treatment arm.|Up to ~14 days post study end (up to ~24 months)|APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.|||percentage of participants|||Number
1221069|NCT00729183|Primary|Percentage of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.|Up to ~14 days post study end (up to ~24 months)|All-Participants-as-Treated (APaT) population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.|||percentage of participants|||Number
1221070|NCT00729183|Primary|Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD)|aBMD (g/cm^2) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and mean BMD measurements from at least 3 evaluable lumbar spine vertebrae (L1-L4) were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal Analysis of Covariates (ANCOVA) model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.|Baseline, 12 months|Full-Analysis-Set (FAS) population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 12 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline (BL) data.|||percent change||95% Confidence Interval|Least Squares Mean
1221071|NCT00729157|Other Pre-specified|To Determine if Changes in Thyroglobulin Concentration After Four Cycles (Approximately 8 Weeks) of IV VEGF-Trap Therapy Correlate With Radiographic Response After Four Cycles (Approximately 8 Weeks)|This part is currently under data analysis, therefore, this outcome measure has not been calculated|8 weeks|||||||
1221072|NCT00729157|Other Pre-specified|To Determine if Pre-treatment Serum VEGF Concentration Correlates With Clinical Outcomes After IV VEGF Trap Therapy in Patients With Recurrent and/or Metastatic D-TC-FCO.|This part is currently under data analysis, therefore, this outcome measure has not been calculatedThis part is currently under data analysis, therefore, this outcome measure has not been calculated.|Baseline-6 months post treatment|||||||
1221073|NCT00729157|Secondary|Effect of Thyroglobulin Concentration on Progression-free Survival|The change is serum thyroglobulin was measured by the percent change between the baseline value and the lowest value obtained while on treatment.|6 months||||percent change serum thyroglobulin||Full Range|Median
1221074|NCT00729157|Secondary|To Determine the Biologic Effect of IV VEGF Trap on FDG Avidity After Four Cycles (Approximately 8 Weeks) of Therapy Through Pre- and Post-treatment FDG-PET Scans in Patients With Recurrent and/or Metastatic D-TC-FCO.|To determine the biologic effect of IV VEGF Trap on FDG avidity after four cycles (approximately 8 weeks) of therapy through pre- and post-treatment FDG-PET scans in patients with recurrent and/or metastatic D-TC-FCO.|8 weeks||||percent of SUVm change||95% Confidence Interval|Median
1221075|NCT00729157|Secondary|The Safety and Toxicity Profile of IV VEGF Trap in Patients With Recurrent and/or Metastatic TC-FCO|The number of participants, with recurrent and/or metastatic TC-FCO, who experienced adverse events. Please see the adverse event table for the specifics for this protocol.|From the beginning of treatment through 30 days until participant comes off study||||participants|||Number
1221091|NCT00728962|Primary|Patients With Implants Achieving Osseous Integration|Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.|1 year|total number of patients enrolled in the study was used for primary outcome analysis|||participants|||Number
1221092|NCT00728949|Primary|Overall Survival (OS)|OS is defined as the interval between date of randomization and the date of death due to any cause. Participants who are alive at the time of study completion will be censored at the time the participants was last known to be alive.|From randomization up to 36.5 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||months||90% Confidence Interval|Median
1221093|NCT00728949|Secondary|Changes in Circulating Tumor Cell Counts (CTS)||Approximately 24 months|Zero participants analyzed. Circulating tumor cell counts were not collected for analysis.||||||
1221076|NCT00729157|Primary|Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions & assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + P RMeasurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (CT, MRI, x-ray) or as ≥ 10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions (or sites of disease), including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm using spiral CT scan), are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT or MRI), & cystic|After 8 weeks of study therapy||||participants|||Number
1221077|NCT00729157|Primary|Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate|Progression-free survival to determine the 6-month progression-free-survival (PFS) rate|6 months||||months||95% Confidence Interval|Median
1221078|NCT00729053|Secondary|Time to Disease Progression.|Time between the date of randomization to the Study Day of documented disease progression (an increase in tumor burden of at least 20%, appearance of new lesions, or unequivocal progression of non-measurable disease) or death (whichever comes first) by RECIST v1.0. Patients who had not progressed at last disease assessment, but whose progression status was unknown at the date last known alive, date of death, or date of study exit (whichever comes first), had event time censored at the date of last assessment. Patients who did not die and did not progress during treatment or follow-up had their event time censored on the last contact date.|Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression|ITT Population|||Days||95% Confidence Interval|Median
1221079|NCT00729053|Secondary|Overall Survival at 1 Year|Overall survival is defined as (date of death +1 - date of randomization). Patients without an event (death) during treatment or follow-up will have their date censored on the last visit the patient was known to be alive.|From date of randomization until the date of progression or date of death from any cause, whichever came first, asses up to 1 year after the last dose of study drug.|ITT Population|||Participants|||Count of Participants
1221080|NCT00729053|Secondary|Duration of Response by RECIST v1.0|Time in days from the date of the first response by RECIST v1.0 to documented disease progression or death from any cause.|Every 8 weeks (2 cycles) from first response to documented disease progression during treatment, 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.|Participants with reported response as reflected in Outcome Measure 1|||Days|||Number
1221081|NCT00729053|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity|Number of patients with Treatment-emergent adverse events (TEAEs) by National Cancer Institute (NCI) grade/severity that began on or after the date of the first injection of study drug or worsened in severity or frequency after study drug was administered.|From start of treatment through one month after the end of study visit (up to 28 weeks)|Safety Population|||Participants|||Count of Participants
1221082|NCT00729053|Primary|Best Response by RECIST v1.0|Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.|From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.|ITT Population|||Participants|||Count of Participants
1221083|NCT00728988|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP)|C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents.|Baseline, 8 hours, 24 hours and 30 days|FAS. N = number of subjects with non-missing values at baseline.|||percent change in CRP||Standard Error|Least Squares Mean
1221084|NCT00728988|Secondary|Percentage of Participants With Elevated Myoglobin|Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
1221085|NCT00728988|Secondary|Percentage of Participants With Elevated Troponin I|Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
1221086|NCT00728988|Secondary|Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)|CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
1221087|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100.|24 hours post PCI|FAS.|||percentage of participants|||Number
1221088|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100.|8 hours post PCI|FAS.|||percentage of participants|||Number
1221171|NCT00728182|Other Pre-specified|Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
1221094|NCT00728949|Secondary|Number of Participants Experiencing Adverse Events (AEs) in National Cancer Institute Common Toxicity Criteria for AE's (NCI-CTCAE) Version 3.0 Criteria for Adverse Events (NCI-CTCAE)|The NCI-CTCAE provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Severity will be graded as mild (grade 1), moderate (grade 2), severe (grade 3), or very severe (life threatening – grade 4). Clinically significant events were defined as serious and other non-serious adverse events related to study drug regardless of causality. A summary of serious and other non-serious adverse events is located in the Reported Adverse Event module.|Randomization to End of Study up to 36.5 Months|Safety population: All participants who received actual treatment of any drug. There is a difference of 6 participants for treatment groups of IMC-A12 (Cixutumumab) + Antiestrogen and IMC-A12 (Cixutumumab) of ITT population and Safety population due to planned treatment (based on randomization) differed from actual treatment.|||Participants|||Count of Participants
1221095|NCT00728949|Secondary|Percentage of Participants With Complete Response (CR) and Partial Response (PR) or Stable Disease (SD) Disease Control Rate [DCR])|DCR is defined as percentage of participants with CR, PR, or SD using RECIST v 1.0 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.|Randomization to PD up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment. Number of participants censored = 15 Cixutumumab + antiestrogen, 5 Cixutumumab only|||percentage of participants||95% Confidence Interval|Number
1221096|NCT00728949|Secondary|12-Month Survival Rate|The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.|From randomization to until the date of first documented date of death from any cause within 12 months, assessed up to 35.1 months|Intent-to-treat (ITT) population: All randomized participants who receive any drug.|||percentage of participants||90% Confidence Interval|Number
1221097|NCT00728949|Secondary|Percentage of Participants With Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])|Best overall response of CR or PR was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of longest diameter (SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Randomization to PD up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||percentage of participants||95% Confidence Interval|Number
1221098|NCT00728949|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the date of randomization until date of objectively determined progressive disease (PD) or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a ≥20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions unequivocal progression of non-target lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS will be estimated following the Kaplan-Meier method.|From randomization up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||months||90% Confidence Interval|Median
1221099|NCT00728923|Secondary|Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.|Patients given HAM-D (Hamilton Depression Scale), a measure of depressive symptoms. For the HAM-D the minimum units are 0 and Maximum units on the total scale are 50. The higher the number on the HAM-D, the more severe the symptoms. Response was defined as at least a 30% reduction on the HAM-D.|12 weeks||||participants|||Number
1221100|NCT00728923|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 30% reduction on the YBOCS.|12 weeks||||participants|||Number
1221101|NCT00728910|Primary|Post-prandial Triglyceride Incremental Area Under the Curve (iAUC)|Triglyceride iAUC was measured during an oral fat tolerance test administered after 4 weeks of atorvastatin 10 mg/day , a further 8 weeks of atorvastatin 10mg /day+ABT335 135mg/day and then after a further 10 weeks of atorvastatin 10 mg/day+ABT335 135 mg/day+Niaspan 2000 mg/day. The standardized oral fat load was administered one hour post medication dosing and blood was collected prior to drug dosing, prior to the oral fat load and hourly thereafter for 10 hours (0,1,2,3,4,5,6,7,8,9,10,12 hrs post drug dosing)|4 weeks, 12 weeks, 22 weeks|subjects completing any phase of treatment for whom complete post-prandial data were available|||mg/dl*h||95% Confidence Interval|Mean
1221102|NCT00728910|Primary|Apo-A1 Production Rate|The apolipoprotein A-I production rate using (5,5,5-2H3-L-leucine) was measured following each of the three study periods i.e following 4 weeks of atorvastatin 10 mg/day, following 8 further weeks of ABT335 135 mg/day added to atorvastatin and following 10 further weeks of ER niacin 2000 mg/day and aspirin 325 mg/day added to atorvastatin+ABT335.|4 weeks, 12 weeks and 22 weeks|Patients who completed any phase of treatment for whom kinetic data were available|||mg/kg/day||95% Confidence Interval|Mean
1244273|NCT00550459|Secondary|Change From Baseline in Serum Sodium; ITT Population|Change from Baseline to Day 22 in Serum Sodium; ITT population|Baseline and Day 22|ITT population with OC|||mEq/L||Standard Deviation|Mean
1221103|NCT00728910|Primary|The Apolipoprotein A-I Fractional Catabolic Rate (FCR)|After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a compartment model to fit data, consisting a precursor compartment (Compartment 1), the plasma leucine pool, an intracellular compartment accounting for apoA1 synthesis and lipoprotein assembly (Compartment 2), and compartments to account for dispositional kinetics of the subfractions including a plasma pool compartment (Compartment 3). The apoA1 FCR corresponds to the rate of irreversible loss of leucine pools from Compartment 3.|4 weeks, 12 weeks and 22 weeks|Patients who completed any of the three phases for whom the kinetic study data was available for any phase of treatment|||pools/day||95% Confidence Interval|Mean
1221104|NCT00728884|Secondary|Crestal Bone Resorption||four years||2018-12-31|12/2018||||
1221105|NCT00728884|Primary|Osseous Integration||one year|total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.|||participants|||Number
1221106|NCT00728845|Secondary|Overall Survival (Phase II)||Treatment start date to date of death|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1221107|NCT00728845|Secondary|Progression-free Survival at 1 Year (Phase II)||Treatment start date to 1 year|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1221108|NCT00728845|Secondary|Time to Progression (Phase II)||Treatment start date and date of progression|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1221109|NCT00728845|Primary|Overall Response (Phase II)||Treatment start date to date of best response|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1221110|NCT00728845|Primary|Recommended Phase II Dose of Hydroxychloroquine and Carboplatin When Administered With Paclitaxel and Bevacizumab (Phase I)||Followed for the duration of the phase 1 treatment, an average of 18 weeks|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1221111|NCT00728819|Secondary|Symptomatic PICC-related Venous Thrombosis|Symptomatic PICC-related venous thrombosis|Procedure through 28 days|Number of participants who had this outcome measure|||Participants|||Count of Participants
1221112|NCT00728819|Secondary|Post-operative Bleeding|Post-operative bleeding|Day 1|Number of participants who received the intervention as assigned|||Participants|||Count of Participants
1221113|NCT00728819|Primary|Evidence of PICC-related Venous Thrombosis|Number participants with vein thrombosis|28 days, PICC removal or hospital discharge||||Participants|||Count of Participants
1221114|NCT00728754|Secondary|Osseous Integration||four years|||||||
1221115|NCT00728754|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis).|||millimeters|implants|Standard Error|Mean
1221116|NCT00728728|Secondary|Clinical Global Impressions (CGI) Scale|The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|Missing data for a total of 5 participants for the CGI.|||score||Standard Error|Mean
1221117|NCT00728728|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
1221118|NCT00728728|Secondary|The Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period.||||total score||Standard Error|Mean
1221119|NCT00728728|Primary|Scale for the Assessment of Negative Symptoms(SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
1221120|NCT00728728|Primary|Brief Assessment of Cognition in Schizophrenia (BACS)|The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||Z score||Standard Error|Mean
1221121|NCT00728728|Primary|University of California Performance-based Skills Assessment (UPSA)|The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
1221122|NCT00728728|Primary|MATRICS Consensus Cognitive Battery (MCCB)|"The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.~The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance."|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||T score||Standard Error|Mean
1221123|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Tmax|Time to maximum plasma concentration(Tmax; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||hours||Standard Deviation|Mean
1221124|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Cmax|Maximum drug concentration in plasma, determined directly from individual concentration-time data (Cmax)|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants as 'per protocol'. Form V group lost a particpant during wash-out period due to death in the family.|||ng/mL||Standard Deviation|Mean
1221125|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-∞|Area under the drug concentration-time curve from time zero to infinity (AUC0-∞; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.|||ng*hr/mL||Standard Deviation|Mean
1221126|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-τ|Area under the drug concentration-time curve from time zero to time t, where t is the last timepoint with a drug concentration ≥ lowest obtainable quantification (AUC0-τ; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||ng*hr/mL||Standard Deviation|Mean
1221127|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: t½|Mean terminal half-life (t½; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from the half-life analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.|||hours||Standard Deviation|Mean
1221128|NCT00728689|Secondary|Number of Study Participants Who Tolerated a Single Dose of ST-246 Form I vs. Form V as Determined by No Clinically Significant Changes in Safety Parameters|"Evaluated safety parameters included:~physical examination/vital signs~electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)~laboratory safety tests (hematology, chemistry, urinalysis)~adverse events For a), b) and c), summary statistics (mean,SD, median, minm, maxm)for values, and changes from baseline(Day 1 pre-dose) to each timepoint, were measured and compared to laboratory normal reference ranges. Values for a)- d) were assigned grades according to DAIDS AE Grading Table. Any Grade of 3 or higher was considered severe and significant."|4 weeks|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||participants|||Number
1221129|NCT00728507|Primary|To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens.|Study was prematurely terminated and data was not collected for this outcome measure.|Weekly or more frequent|||||||
1221130|NCT00728507|Primary|To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy.|LJ culture conversion|Week 8|modified intention to treat population|||percentage of participants|||Number
1221131|NCT00728494|Primary|The Number of Participants Who Relapsed at 6 Months Post-treatment|Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment|Measured at end of treatment and 6 months post-treatment||||Participants|||Number
1221132|NCT00728494|Primary|The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment|Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment|Measured at 6 months post-treatment||||Participants|||Number
1221133|NCT00728494|Secondary|Average Dosage of Rebetol|Rebetol dosage was expressed in milligrams per kilogram of body weight per day.|Up to 48-week treatment duration||||mg/kg/day||Standard Deviation|Mean
1221134|NCT00728494|Secondary|Average Dosage of PegIntron|Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week|Up to 48-week treatment duration||||micrograms/kg/week||Standard Deviation|Mean
1221135|NCT00728494|Secondary|Average Length of Treatment|Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.|Maximum 48-week treatment duration||||Participants|||Number
1221136|NCT00728494|Primary|The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C|Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program|At the end of the 48-week treatment period||||Participants|||Number
1221137|NCT00728481|Primary|Symptomatic Response to Treatment|"Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30).~Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study."|Baseline, 6 months||||Participants|||Number
1221138|NCT00728481|Secondary|Participants With Presence of Erosive Esophagitis at Six Month Endoscopy||Baseline, 6 months||||participants|||Number
1221139|NCT00728481|Secondary|Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy|Multiple concentric rings or furrows of the esophagus is an endoscopic finding traditionally ascribed to eosinophilic esophagitis.|Baseline, 6 months||||participants|||Number
1221140|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.|Baseline, 6 months|The analysis population for this item only included subjects with a non-significant histologic response. Subjects were considered to have a histological response to treatment if both sets of 6-month biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.|||Participants|||Number
1221141|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Symptomatic improvement was defined as only an improvement of 2 levels on this question.|Baseline, 6 months|The analysis population includes only subjects with a histologic response. Subjects were considered to have a histological response to treatment if both sets of biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.|||Participants|||Number
1221142|NCT00728481|Primary|Histological Response to Treatment|Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.|Baseline, 6 months||||Participants|||Number
1221143|NCT00728468|Other Pre-specified|Ratio of Dextromethorphan Area Under the Curve to Dextrorphan Area Under the Curve on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator’s decision.||||||
1221144|NCT00728468|Other Pre-specified|Ratio of Dextromethorphan Area Under the Curve to Dextrorphan Area Under the Curve 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator’s decision.||||||
1221145|NCT00728468|Secondary|Time to Tumor Progression (TTP)|Time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.437. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD).|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|All enrolled participants|||months||95% Confidence Interval|Median
1221146|NCT00728468|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|Participants with a response (CR or PR) in response analysis set.|||weeks||95% Confidence Interval|Median
1221147|NCT00728468|Secondary|Best Overall Response (BOR)|BOR: investigator assessment by Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD): >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|Response anslysis set: all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment.|||participants|||Number
1221148|NCT00728468|Primary|Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan on Cycle 2 Day 7|The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day 7 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day 7.|8 hours after dosing on Day 7|PK parameter analysis population|||ratio||Standard Deviation|Mean
1221172|NCT00728182|Other Pre-specified|Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose (pre-specified subgroup analysis)|Enrolment, Days 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
1221149|NCT00728468|Primary|Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan 3 Days Prior to PF-00299804 Dosing|The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day -3 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day -3.|8 hours after dosing on Day -3|PK parameter analysis population: all participants enrolled who were extensive metabolizers (EM), & treated who had at least 1 PK parameter of primary interest in at least 1 treatment period. EMs were defined as participants with a baseline UMR ≤0.3 & were either ultrarapid, extensive, or intermediate metabolizers as predicted by CYP2D6 genotyping.|||ratio||Standard Deviation|Mean
1221150|NCT00728468|Primary|Oral Clearance For Dextromethorphan on Cycle 2 Day 7|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.||||||
1221151|NCT00728468|Primary|Oral Clearance For Dextromethorphan 3 Days Prior to PF-00299804 Dosing|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.||||||
1221152|NCT00728468|Primary|Plasma Decay Half-Life (t1/2) For Dextrorphan on Cycle 2 Day 7|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Standard Deviation|Mean
1221153|NCT00728468|Primary|Plasma Decay Half-Life (t1/2) For Dextrorphan 3 Days Prior to PF-00299804 Dosing|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Standard Deviation|Mean
1221154|NCT00728468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Full Range|Median
1221155|NCT00728468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Full Range|Median
1221156|NCT00728468|Primary|Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng/mL||Standard Deviation|Mean
1221157|NCT00728468|Primary|Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng/mL||Standard Deviation|Mean
1221158|NCT00728468|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan on Cycle 2 Day 7|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
1221191|NCT00727857|Secondary|Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration|The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1221222|NCT00727714|Primary|Changes in Lung Function Measurements During One Work Shift (6-8h)|Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity|baseline and 6-8h||||Litres||Standard Deviation|Mean
1221159|NCT00728468|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan 3 Days Prior to PF-00299804 Dosing|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
1221160|NCT00728468|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
1221161|NCT00728468|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Pharmacokinetic (PK) analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||nanograms*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1221162|NCT00728416|Secondary|Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1221163|NCT00728416|Primary|Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1221164|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 31 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1221165|NCT00728260|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database – All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 doses|||Number
1221166|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 0 up to Day 30 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1221167|NCT00728182|Other Pre-specified|Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 with ruptured aneurysms was compared in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30||||No. of participants with mRS 0-2|||Number
1221168|NCT00728182|Other Pre-specified|National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for participants with ruptured aneurysms in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30|All subjects who entered the study with a ruptured aneurysm, who received study drug and outcome assessment at Day 30.|||No. of participants with NIHSS 0-1|||Number
1221169|NCT00728182|Other Pre-specified|Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
1221170|NCT00728182|Other Pre-specified|Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
1221173|NCT00728182|Secondary|Modified Rankin Scale (mRS).|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 was compared in both treatment groups.|Enrolment, Day 30|All patients who received study drug and an outcome assessment at Day 30|||No. of participants with mRS 0-2|||Number
1221174|NCT00728182|Secondary|National Institutes of Health Stroke Scale (NIHSS).|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for both groups.|Enrolment, Day 30|All patients who received study drug and outcome assessment at Day 30.|||No. of participants with NIHSS 0-1|||Number
1221175|NCT00728182|Secondary|Volume of New DWI Lesions (MRI)|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
1221176|NCT00728182|Secondary|Number of New FLAIR Lesions (MRI)|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI scan at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
1221177|NCT00728182|Secondary|Number of New DWI Lesions (MRI)|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose.|Enrolment, Day 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
1221178|NCT00728182|Primary|Volume of New FLAIR Lesions(MRI)|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose|Enrolment, Days 2-4|All study patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
1221179|NCT00728130|Secondary|The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.|Pathological detection of carcinoma within each of the dissected nodes reported as node groups.|Post surgical time point||||carcinoma positive nodes||Standard Deviation|Mean
1221180|NCT00728130|Primary|the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.|The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.|Post Surgical Time point||||nodes||Standard Deviation|Mean
1221181|NCT00727961|Primary|Number of Participants With Progression|Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
1221182|NCT00727961|Primary|Number of Participants With Stabilization|All other subjects (except complete or partial responders and those with progression [see prior definitions]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
1221183|NCT00727961|Primary|Number of Participants With Partial Response|Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
1221184|NCT00727961|Secondary|Mean Survival Time During the Study|Mean time to the occurrence of death|from the beginning of study drug administration up to 18 months||||days||95% Confidence Interval|Mean
1221185|NCT00727961|Secondary|Median Time to Progression|Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|from the beginning of study drug administration up to 4 weeks after chemotherapy completed||||days||95% Confidence Interval|Median
1221186|NCT00727961|Secondary|Mean Time to Positive (Partial) Treatment Response Achievement|"Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.~Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions."|from the beginning of study drug administration up to 4 weeks after chemotherapy completed||||days||Standard Deviation|Mean
1221187|NCT00727961|Primary|Number of Participants With Complete Response|Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||participants|||Number
1221188|NCT00727909|Primary|Percentage of Participants That Selected a Particular Type of Hearing Aid||At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)||||percentage of participants|||Number
1221189|NCT00727857|Secondary|Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration|The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||nmol/L||Standard Error|Least Squares Mean
1221190|NCT00727857|Secondary|Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration|The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1221705|NCT00724815|Secondary|Nausea Free at Two Hours|Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
1221200|NCT00727857|Secondary|Change From Baseline in Small Low Density Lipoprotein Concentration|The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1221201|NCT00727857|Secondary|Change From Baseline in Medium-Small Low Density Lipoprotein Concentration|The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1221202|NCT00727857|Secondary|Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration|The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1221203|NCT00727857|Secondary|Change From Baseline in Large Low Density Lipoprotein (L3) Concentration|The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1221204|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Size|The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Deviation|Least Squares Mean
1221205|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Concentration|The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||nmol/L||Standard Error|Least Squares Mean
1221206|NCT00727857|Secondary|Change From Baseline in Triglycerides|The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1221207|NCT00727857|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1221208|NCT00727857|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1221209|NCT00727857|Secondary|Change From Baseline in Total Cholesterol|The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1221210|NCT00727857|Secondary|Change From Baseline in Adiponectin|The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mcg/ml||Standard Error|Least Squares Mean
1221211|NCT00727857|Secondary|Median Percent Change From Baseline in High Sensitivity C-reactive Protein|Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: [(Week 24 - baseline levels)/baseline]*100|Baseline and Week 24||||percent||Full Range|Median
1221212|NCT00727857|Secondary|Change From Baseline in Homeostasis Model Assessment - Insulin Resistance|The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||percent of insulin resistance||Standard Error|Least Squares Mean
1221213|NCT00727857|Secondary|Change From Baseline in Fasting Insulin|The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||μIU/mL||Standard Error|Least Squares Mean
1221214|NCT00727857|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1221215|NCT00727857|Primary|Percent Change From Baseline in Glycosylated Hemoglobin|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1221216|NCT00727844|Primary|Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months.||Sputum smear conversion or max 4 months after the start of Linezolid therapy.||||participants|||Number
1221217|NCT00727740|Primary|Reduction in Pancreatitis Rate|Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.|24 hours||||percentage of participants with PEP|||Number
1221218|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h||0-32h||||ng/Litre||Full Range|Median
1221219|NCT00727714|Secondary|Changes in FeNO Measurements Between Baseline (0h) and 32 h||0-32h||||ppb||Full Range|Median
1221220|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)||Baseline and 6-8h||||ng/Litre||Full Range|Median
1221223|NCT00727649|Secondary|Fecal Incontinence Severity Index Score, FISI|The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms.|baseline, 4 week and 12 weeks||||units on a scale||Standard Deviation|Mean
1221224|NCT00727649|Primary|Percentage of Bowel Movements With Incontinence|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.|4 weeks||||percentage of incontinent bowel movement||Standard Deviation|Mean
1221225|NCT00727649|Primary|7-day Bowel Diary, Number of Fecal Incontinence Episodes|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.|6 weeks and 12 weeks||||Fecal incontinence episodes||Standard Deviation|Mean
1221226|NCT00727636|Primary|Antibody Titer to HPV 18|Geometric mean titer (95%CI)|Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1221227|NCT00727636|Primary|Antibody Titers to HPV 16|Geometric mean titer (95% CI)|Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1221228|NCT00727636|Primary|Antibody Titer to HPV 11||Month 7|Number of participants who completed all vaccine doses|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1221229|NCT00727636|Primary|Antibody Titer to HPV 6||Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1221230|NCT00727597|Primary|Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events||96 weeks||||participants|||Number
1221231|NCT00727597|Primary|Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)|"Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons:~To resolve a Grade 3 or 4 Adverse Event~The subject experienced a virologic failure (as defined in section 3.6.2)~The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue~The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"|96 weeks||||participants|||Number
1221232|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Right Leg|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pounds||Standard Deviation|Mean
1221233|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Left Leg.|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pounds||Standard Deviation|Mean
1221234|NCT00727571|Secondary|Physical Performance: Grip Strength|Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pound-force||Standard Deviation|Mean
1221235|NCT00727571|Secondary|Physical Performance: Time to Rise From Sitting to Standing|Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||seconds||Inter-Quartile Range|Median
1221236|NCT00727571|Secondary|Physical Performance: Duration Walked or Wheeled at Each Visit|The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||minutes||Standard Deviation|Mean
1221237|NCT00727571|Secondary|Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||feet per minute||Standard Deviation|Mean
1221238|NCT00727571|Secondary|Estimated Glomerular Filtration Rate (GFR) for Participants With CKD|Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x [Serum creatinine]^-1.154 x [Age]^-0.203 x [0.742 if patient is female] x [1.210 if patient is black]. 2. Cockcroft-Gault formula: GFR = (140-age) * (Weight in kg) * (0.85 if female) / (72 * Serum Creatinine).|Weeks 1, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||mL/min/1.73 m^2||Standard Deviation|Mean
1221256|NCT00727506|Secondary|Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase I|Safety of afatinib as indicated by number of participants with adverse events based on intensity and incidence of AE's, especially skin reactions (rash, acne), gastrointestinal (GI) (Vomiting, nausea, diarrhea) and neurological|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
1221239|NCT00727571|Secondary|Percentage of Participants With Anemia Related Conditions at Baseline|"The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative.~Vitamin B12 and folate deficiency based on standard laboratory ranges."|Baseline|Enrolled patients with anemia|||Percentage of participants|||Number
1221240|NCT00727571|Secondary|Number of Participants With Anemia|Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin <12 g/dL in women, < 13 g/dL in men.|Baseline|All enrolled patients with available anemia lab results.|||participants|||Number
1221241|NCT00727571|Primary|Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||feet||Inter-Quartile Range|Median
1221242|NCT00727558|Secondary|Inferior Region Corneal Staining|National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=243).|||Units on a scale||Standard Error|Least Squares Mean
1221243|NCT00727558|Secondary|Initial Comfort|"Rating of comfort immediately when you first put them on using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent."|at 1 week|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
1221244|NCT00727558|Secondary|End of Day Comfort|Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
1221245|NCT00727558|Secondary|How Comfortable Eyes Feel at the End of the Day|"Rating of How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable."|at 1 week wear|Analysis includes participants who completed the study per protocol and had no missing data.|||Units on a scale||Standard Error|Least Squares Mean
1221246|NCT00727558|Secondary|Overall Handling|Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
1221247|NCT00727558|Primary|Measured Limbal Hyperemia|Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|at 1 week of wear.|Analysis includes participants who completed the study per protocol and had no missing data (n=243).|||Units on a scale||Standard Error|Least Squares Mean
1221248|NCT00727558|Primary|Overall Comfort|Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear.|Analysis includes participants who completed the protocol and had no missing data (n=240)|||Units on a scale||Standard Error|Least Squares Mean
1221249|NCT00727506|Secondary|Number of Participants With Clinically Relevant Abnormalities for Decreased Cardiac Left Ventricular Function - Phase II|Number of participants with Clinically Relevant Abnormalities for decreased Cardiac left ventricular function.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
1221250|NCT00727506|Secondary|Causes of Death - Phase II|Causes of death during on treatment.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||deaths|||Number
1221251|NCT00727506|Secondary|Number of Participants With Adverse Events, Graded According CTCAE - Phase II|Safety of Afatinib assessed based on the number of participants with adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
1221252|NCT00727506|Secondary|Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase II|Safety of afatinib as indicated by number of participants with adverse events based on intensity and incidence of AE's, especially skin reactions (rash, acne), gastrointestinal (GI) (Vomiting, nausea, diarrhea) and neurological.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
1221253|NCT00727506|Secondary|Number of Participants With Investigator Defined Drug−Related AEs, AE Leading to Dose Reduction, AEs Leading to Discontinuation of Trial Drug and All SAE- Phase II|Safety was assessed based on number of participants with investigator defined drug−related AEs, AE leading to dose reduction, Adverse events (AEs) leading to discontinuation of trial drug and All Serious Adverse events (SAE).|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
1221254|NCT00727506|Secondary|Causes of Death - Phase I|Cause of the death reported during on treatment was due to disease progression.|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||deaths|||Number
1221255|NCT00727506|Secondary|Number of Participants With Adverse Events, Graded According CTCAE - Phase I|Safety of Afatinib assesed based on Number of participants with adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
1221257|NCT00727506|Secondary|Number of Participants With Investigator Defined Drug−Related AEs, AEs Leading to Discontinuation of Trial Drug, All Serious Adverse Events (AE) and Other Significant AEs - Phase I|Safety was assessed based on number of participants with investigator defined drug−related AEs, AEs leading to discontinuation of trial drug, All Serious Adverse events (AE) and other significant AEs (according to International Conference on Harmonisation (ICH) E3).|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
1221258|NCT00727506|Secondary|Number of Participants With Chromosomes (CEP10) Assessed by FISH|Number of participants with Chromosomes (CEP10) assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Chromosomes (CEP10) by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
1221259|NCT00727506|Secondary|Number of Participants With Chromosomes (CEP7) Assessed by FISH|Number of participants with Chromosomes (CEP7) assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Chromosomes (CEP7) by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
1221260|NCT00727506|Secondary|Number of Participants With PTEN Assessed by FISH|Number of participants with PTEN assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for PTEN by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
1221261|NCT00727506|Secondary|Number of Participants With EGFR Assessed by FISH|Number of participants with EGFR assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for EGFR by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
1221262|NCT00727506|Secondary|Number of Participants With PAKT Marker Assessed by IHC Test.|Number of participants with PAKT marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Serinethreonine kinase (PAKT) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
1221263|NCT00727506|Secondary|Number of Participants With PTEN Marker Assessed by IHC Test.|Number of participants with PTEN marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Phosphatase and Tensin Homologue – a tumor suppressor gene/protein (PTEN) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
1221264|NCT00727506|Secondary|Number of Participants With EGFR Marker Assessed by IHC Test.|Number of participants with EGFR marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Epidermal Growth Factor Receptor (EGFR) by immunohistochemistry (IHC) test|Baseline (during screening)|Randomized set|||Participants|||Number
1221265|NCT00727506|Secondary|Number of Participants With MGMT Marker Assessed by IHC Test.|Number of participants with MGMT marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for O6-methylguanine-DNA methyltransferase (MGMT) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
1221266|NCT00727506|Secondary|Number of Participants With EGFRvIII Assessed by IHC Test.|Number of participants with the epidermal growth factor receptor variant III (EGFRvIII) assessed by IHC test for the evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for EGFRvIII by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
1221267|NCT00727506|Secondary|Phase II - Trough Plasma Concentration of Afatinib|Trough plasma concentration of afatinib after multiple administration of 40 mg afatinib administered as monotherapy or in combination with 75 mg/m² temozolomide|Before (-0.05 h) the drug administration of afatinib on Day 15 of Cycle 2 & 3|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1221268|NCT00727506|Secondary|t1/2 for Temozolomide|terminal half-life (t1/2) of temozolomide in presence and absence of afatinib|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||hours||Geometric Coefficient of Variation|Geometric Mean
1221269|NCT00727506|Secondary|Tmax for Temozolomide|time from dosing to the maximum plasma concentration following the first dose of uniform intervals τ (tmax) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||h||Full Range|Median
1221270|NCT00727506|Secondary|Cmax for Temozolomide|maximum measured plasma concentration following the first dose of uniform intervals τ (Cmax) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1221271|NCT00727506|Secondary|AUC (0-8) for Temozolomide|Area under the plasma concentration-time curve over the time interval from zero to 08h (AUC (0-8)) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1221272|NCT00727506|Secondary|Tmax,ss for Afatinib|time from dosing to the maximum plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS set|||hour||Full Range|Median
1221286|NCT00727311|Primary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA~negativity from baseline to Week 12"|Treatment Week 12|Number of evaluable participants at 12 weeks of treatment|||Participants|||Number
1221273|NCT00727506|Secondary|Cmax,ss for Afatinib|maximum measured plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide.|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS set|||ng/mL||Standard Deviation|Geometric Mean
1221274|NCT00727506|Secondary|AUCτ,ss for Afatinib|Area under the plasma concentration-time curve of afatinib after multiple administration (AUCτ,ss) of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide (TMZ).|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24 h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS Set and the patients who had enough PK samples for calculation of AUC. Pharmacokinetic set (PKS) : All patients who provided at least one blood sample were included in the Pharmacokinetic (PK) analysis.|||ng·h/mL||Standard Deviation|Geometric Mean
1221275|NCT00727506|Secondary|Progression-free Survival (PFS)- Phase II Part|Progression-free survival was defined as the duration between randomization and the date of the first of the two following events: progression or death.|from date of randomization until the date of first documented progression or death by any cause, whichever came first, assessed up to 9 Months.|Randomized set|||Months||Full Range|Median
1221276|NCT00727506|Secondary|Objective Tumor Response in Phase II|Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review. Only data collected until cut-off date July 15, 2016 were considered.|From randomization to until the date of first documented progression or data cutoff on July 15, 2016, whichever came first, with a mean treatment duration of 110.0 days|RS|||participants|||Number
1221277|NCT00727506|Secondary|Objective Tumor Response in Phase I|Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review.|From treatment start until the date of first documented progression or data cutoff at May 12, 2011, whichever came first, with a mean treatment duration of 69.7 days.|Patients treated in Phase I part|||participants|||Number
1221278|NCT00727506|Primary|Progression-free Survival (PFS-6) at Six Months - Phase II|"PFS-6 is defined as probability of patients surviving to six months after randomization without progression. Disease progression was evaluated by an independent review committee and by the investigators, independently. The evaluation by the independent review committee was used for the primary outcome measure. The measurement Number the estimated PFS-6 value from the Kaplan-Meier curve of PFS."|At six months after randomization|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment in the Phase II part of the trial.|||probablity of survival||95% Confidence Interval|Number
1221279|NCT00727506|Primary|Number of Participants With DLT- Phase I|Number of Participants With Dose Limiting Toxicities (DLT) - Phase I Part|From randomization till data cut-off (10 Jun 2009), with a mean treatment duration of 51 days||||participants|||Number
1221280|NCT00727402|Primary|Cumulative Incidence of Corneal Inflammatory Events|Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.|annual||||annual incidence per 100 subjects|Participants|95% Confidence Interval|Mean
1221281|NCT00727337|Secondary|Hearing Handicap Inventory for the Elderly (HHI) Change|The HHI is a 25-item questionnaire that assesses the social and emotional consequences of hearing loss. The HHI for the elderly is for individuals age 65 years and older (Ventry & Weinstein 1982); the HHI for adults is for individuals aged 64 years and younger (Newman et al. 1990). The versions differ in the wording of three questions. The participants were asked to complete the appropriate HHI for aided listening to reflect their residual hearing handicap. HHI items are answered on a scale of Yes (4 points), Sometimes (2 points) and No (0 points), with higher scores indicating greater reported hearing handicap. Total HHI scores, which can range from 0 to 100, were used for all analyses.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||units on a scale||Standard Deviation|Mean
1221282|NCT00727337|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB) Change|The Abbreviated Profile of Hearing Aid Performance (APHAP; Cox & Alexander 1995) was used to assess activity limitations and the Hearing Handicap Inventory for the Elderly or Adults (HHI; Ventry & Weinstein 1982; Newman et al. 1990) was used to assess participation restrictions. The APHAP is a 24-item questionnaire that documents hearing difficulties in specified listening situations. The items are answered on a 7-point scale from ‘Always’ (or 99%) to ‘Never’ (or 1%) with higher scores indicating greater reported hearing difficulty. The APHAP global score that ranges from 1 to 99 was used for all analyses.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||units on a scale||Standard Deviation|Mean
1221283|NCT00727337|Primary|Words-in-Noise Test (WIN) Change|Monosyllabic words (NU-6 female version) with a carrier phrase were presented auditory only in a multitalker babble.The participant is asked to repeat the last word of each phrase. The total number of correct words is input into the Spearman-Karber equation to derive a 50% point. This is the signal-to-noise ratio in dB that an individual requires to get 50% of the words correct. This test was completed at baseline and follow up visits.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||dB SNR||Standard Deviation|Mean
1221284|NCT00727311|Primary|Number of HCV-RNA Negative Participants at Follow-up|HCV-RNA was measured by PCR.|24 weeks post-treatment (Weeks 48 or 72, depending on genotype)|Number of participants with results at the 6 month follow-up examination|||Participants|||Number
1221285|NCT00727311|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT|24 weeks post-treatment (Week 48 or 72, depending on genotype)|Number of evaluable participants with follow-up information|||Participants|||Number
1221297|NCT00727220|Primary|Change in HgBA1c||Baseline and 6 months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1221287|NCT00727311|Primary|Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)|HCV-RNA level was measured by polymerase chain reaction (PCR).|24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6|Number of evaluable participants at EoT|||Participants|||Number
1221288|NCT00727298|Secondary|Clinicians' Impression of Therapeutic Efficacy|Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.|Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.|||Percentage of Participants|||Number
1221289|NCT00727298|Secondary|Clinicians' Impression of Disease Severity From Baseline to Week 102|Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.|Baseline, Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.|||Percentage of Participants|||Number
1221290|NCT00727298|Primary|Number of Participants Experiencing at Least One Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.|Baseline to Month 24|The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.|||Participants|||Number
1221291|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
1221292|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
1221293|NCT00727272|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng/mL||Standard Deviation|Mean
1221294|NCT00727259|Primary|Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months|Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).|The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.|Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects.|||satisfaction rating from 0-7||Standard Deviation|Mean
1221295|NCT00727246|Primary|Cognitive Composite Score for Group of Subjects With TBI and Unmatched Healthy Controls|A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. Higher T-scores indicate higher levels of cognitive functioning. Due to the small number of subjects in this study, this second analysis was completed using the same number of subjects in the TBI and control groups, but without matching so that a slightly larger number of subject's data could be utilized. Although analyses were run, due to the very small number of participants in this study, results should be considered with caution.|6 weeks|cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. See note above related to the limited number of subjects in each group.|||T-score||95% Confidence Interval|Mean
1221296|NCT00727246|Primary|Cognitive Composite Score for Group of Subjects With TBI and Healthy Controls Matched by Age, Education, and Treatment Group.|.A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. A higher T-score indicates a higher level of cognitive function. Due to matching criteria of age range, gender and education level, as well as the small number of subjects with TBI who complete the study (n = 5), matched groups required a reduction to 2 subjects per group for analysis as planned per protocol. Due to the small number of subjects in this study overall, although analyses were run, results should be considered with caution.|6 weeks|A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of subjects with TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. Matching criteria and small n for TBI group reduced group sizes.|||T-score||95% Confidence Interval|Mean
1221298|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Ptosis)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.|||units on a scale||Standard Deviation|Mean
1221299|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Double Vision)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.|||units on a scale||Standard Deviation|Mean
1221300|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Negative Inspiratory Force. NIF is a measurement of respiratory muscle strength and ventilator reserve. NIF is represented by centimeters of water pressure (cmH2O). A normal NIF measurement is negative 60 cmH2O, or as 100% predicted value.|16 weeks|Comparison of NIF at the Last Visit Between Eculizumab and Placebo Cohorts.|||percentage of predicted||Standard Deviation|Mean
1221301|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Forced Vital Capacity|16 weeks|Comparison of FVC at the Last Visit Between Eculizumab and Placebo Cohorts.|||percentage of predicted||Standard Deviation|Mean
1221302|NCT00727194|Secondary|Change From Baseline in the QoL Instrument, SF-36.|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (physical functioning, role-physical, bodily pain, general health, mental health, role-emotional, social functioning and vitality) as well as psychometrically-based physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group. The lower the score the more disability; the higher the score the less disability. Norm-based scoring involving a linear T-score transformation method was used so that scores for each of the health domain scales and component summary measures have a mean of 50 and a standard deviation of 10 based on the 1998 US general population. Thus, scores above and below 50 are above and below the average, respectively, in the 1998 US general.|16 weeks|Comparison of SF-36 at the Last Visit Between Eculizumab and Placebo Cohorts.|||units on a scale||Standard Deviation|Mean
1221303|NCT00727194|Secondary|Change From Baseline in the MG-Activity of Daily Living Profile (MG-ADL)|The MG-ADL is an 8-point questionnaire that focuses on relevant symptoms and functional performance of activities of daily living (ADL) in MG patients. The 8 items of the MG-ADL were derived from symptom-based components of the original 13-item QMG to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 – 24. MG-ADL was to be performed at every study visit. The recall period for MG-ADL was since the preceding study visit (1 or 2 weeks).|16 weeks|Comparison of MG Activities of Daily Living (Total score) at the Last Visit Between Eculizumab and Placebo Cohorts.|||units on a scale||Standard Deviation|Mean
1221304|NCT00727194|Secondary|Change From Baseline in the MGFA Post-Intervention Status (PIS)|The MGFA PIS is designed to assess the clinical state of MG patients at any time after treatment of MG is initiated. Change in status categories of Improved, Unchanged, Worse, Exacerbation, and Died of MG was to be assessed and recorded at every visit from Visits 3 to 24 (Weeks 1 to 16). Minimal manifestations were to be assessed at these visits.|16 weeks||||participants|||Number
1221305|NCT00727194|Secondary|Mean Change From Baseline in QMG Total Score|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The Myasthenia Gravis Foundation of America task force has recommended that the QMG score be used in prospective studies of therapy for MG. The QMG scoring system consists of 13 items. Each item is graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0-39.|16 weeks||||units on a scale||Standard Deviation|Mean
1221306|NCT00727194|Primary|Quantitative Myasthenia Gravis (QMG): The Primary Efficacy Endpoint in This Study Was the Percentage of Patients With a 3-point Reduction From Baseline in the QMG Total Score for Disease Severity.|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG.|16 weeks||||percentage of patients|||Number
1221307|NCT00727090|Secondary|Glasgow Coma Scale|Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)|48 hours|||||||
1221308|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 48 Hours||48 hours||||mMol/L||Standard Deviation|Mean
1221309|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 36 Hours||36 hours||||mMol/L||Standard Deviation|Mean
1221310|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 24 Hours||24 hours||||mMol/L||Standard Deviation|Mean
1221311|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 18 Hours||18 hours||||mMol/L||Standard Deviation|Mean
1221312|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 12 Hours||12 hours||||mMol/L||Standard Deviation|Mean
1221313|NCT00727090|Secondary|NIH Stroke Scale|Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).|48 hours|||||||
1221315|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
1221316|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status|Cmax is a measure of drug metabolism and is presented as least squares geometric mean with 90% Confidence Interval.Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
1221317|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
1221318|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|Cmax is a measure of drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
1221319|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
1221320|NCT00727064|Primary|Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status|Cmax is a measure of drug metabolism and presented as least squares geometric mean with 90% Confidence Interval. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
1221321|NCT00727025|Primary|Time to Perform Wound Closure|Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture|intraoperatively|those who completed application of devices intraoperatively|||minutes||Standard Deviation|Mean
1221322|NCT00727025|Secondary|Patient Postoperative Incisional Comfort|Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable|10 days||||units on a scale||Standard Deviation|Mean
1221323|NCT00727025|Primary|Scar Quality at 6 Months Postoperative|Patients used a rating scale with range of 1-9 with 1 being the best scar and 9 being the worst scar. Patients had photos of scars within this range to anchor their choices.|6 months||||units on a scale||Standard Deviation|Mean
1221324|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 2||||mg/kg/h||Standard Deviation|Mean
1221325|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 1||||mg/kg/h||Standard Deviation|Mean
1221326|NCT00726999|Secondary|Side Effect Occurrence|The number of episodes of/occurrence of side effects was monitored in both groups.|First 10 days after surgery|||||||
1221327|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)|Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.|PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)||||mg/kg/h||Standard Deviation|Mean
1221328|NCT00726986|Secondary|Safety|Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.|Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||participants|||Number
1221329|NCT00726986|Secondary|Response Rate|"The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|reevaluated for response every 8 weeks|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||participants|||Number
1221330|NCT00726986|Secondary|Median Overall Survival|Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||months||95% Confidence Interval|Median
1221331|NCT00726986|Primary|Progression-free Survival(PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||months||95% Confidence Interval|Median
1221332|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
1221333|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
1221334|NCT00726895|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng/mL||Standard Deviation|Mean
1221335|NCT00726882|Secondary|Number of Participants With Serious Adverse Events Related to Study Procedures|Only serious adverse events that the investigator considered causally related to study procedures (i.e., venipuncture) were to be collected in this study. A serious adverse event was defined as any untoward medical occurrence in a clinical investigation subject that the investigator believed to be causally related to a study procedure and met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.|48 weeks||||participants|||Number
1221336|NCT00726882|Primary|Persistence of Resistance-Associated Variants and Phenotypic Resistance|Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.|Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks|Resistance analyses included all participants who received ABT-333 in the previous study who had sufficient HCV RNA recovered from samples collected during this study for genotypic and phenotypic analysis to proceed. m, n = the number of evaluable participants for the analysis specified for M10-380 and M10-351, respectively.|||participants|||Number
1221337|NCT00726830|Secondary|Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items||28 days|||||||
1221338|NCT00726830|Primary|Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)|MDASI questionnaire completed on days 8, 15, and 22 after enrollment. The ‘primary success’ is defined as a 3-point reduction in pain score on the MDASI. Scores from baseline and from four weeks later compared using the MDASI average pain intensity on a scale of 0 (no pain) to 10 (worst pain).|28 days|No Analysis accomplished as there is not sufficient participant data to meet the study end points.||||||
1221339|NCT00726752|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.|Up to 470 days of treatment plus 28-days follow-up|Safety analysis set was defined as all enrolled participants who received the study drug at least once in this study (same as the full analysis set:FAS).|||participants|||Number
1221340|NCT00726752|Secondary|Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 470 days|Anti-tumor response analysis set was defined as all participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug.|||participants|||Number
1221341|NCT00726752|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF|Prior to the initial dose (baseline) and Day 1 of Cycle 2|Pharmacodynamic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacodynamic blood sampling for at least 1 day.|||percent||Full Range|Median
1221342|NCT00726752|Secondary|Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ratio||Standard Deviation|Mean
1221343|NCT00726752|Secondary|Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Full Range|Median
1221344|NCT00726752|Secondary|Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 12 hours in this study.|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng*h/mL||Standard Deviation|Mean
1221345|NCT00726752|Secondary|Multiple Dose: Maximum Observed Plasma Concentration (Cmax)|Cmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng/mL||Standard Deviation|Mean
1221346|NCT00726752|Primary|Single Dose: Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Standard Deviation|Mean
1221347|NCT00726752|Primary|Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Full Range|Median
1221348|NCT00726752|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng*hr/mL||Standard Deviation|Mean
1221349|NCT00726752|Primary|Single Dose: Maximum Observed Plasma Concentration (Cmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng/mL||Standard Deviation|Mean
1221350|NCT00726739|Secondary|Immune Response|Immune responses is be assessed by Delayed Type Hypersensitive (DTH) responses to LMI, IFN-γ production by CD8 T cells using the ELISPOT assay, and CD8 T cell binding to HLA-A2 multimers complexed with melanoma-derived peptides (pentamer analysis). DTH reactions are determined at 48 hours by measuring the largest diameter and right angle diameter of the area of induration and calculating the mean. DTH responses are recorded as present or absent but cannot be used as a quantitative measure of immune activation.|48 hours After Study Medication||||participants|||Number
1221351|NCT00726739|Secondary|Overall Survival at 1 Year|One year survival (alive at 1 year from randomization) rate of each treatment group.|1 Year||||Percentage of patients|||Number
1221352|NCT00726739|Secondary|Overall Survival at 2 Years|Two year survival (alive at 2 years from randomization) rate of each treatment group.|2 Years||||percentage of patients|||Number
1221353|NCT00726739|Secondary|Clinical Response of Lesion(s)|Beginning at 2 months Through End of Treatment: To determine clinical response of each treatment group - Best Clinical response will be determined using Solid Tumor Response Criteria (RECIST). Complete Response (CR) = complete disappearance of all target lesions. Partial Response (PR) = At least a 30% decrease in sum of longest diameters of target lesions. Progressive Disease (PD) = At least a 20% increase in sum of longest diameters of target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR or PD.|Month 2 through Month 12|All patients who received at least one dose of study treatment are included. One patient who was originally screened did not receive treatment due to brain metastasis.|||participants|||Number
1221354|NCT00726739|Primary|Median Time of Progression-free Survival|Progression free survival (PFS) was measured in months from date of randomization to date of disease progression, or date of death. For patients who died without tumor progression, PFS assumes their deaths are randomly related to tumor progression. Therefore, PFS includes deaths if they came first.|From Date of Randomization to Date of Disease Progression or Last Contact - up to 2 years.|All patients who received at least one dose of study treatment are included. One patient who was originally screened and randomized did not receive treatment due to brain metastasis. This patient was included in PFS analysis based on the intent-to-treat principle, but was excluded from the evaluation of adverse events.|||Months||Full Range|Median
1221355|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including Potential Antioxidant (PAO)|Analyte levels were taken at 0 (Baseline) and 24 weeks||||µmol/L||Standard Deviation|Mean
1221356|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including hs-CRP|Analyte levels were taken at 0 (Baseline) and 24 weeks||||mg/L||Standard Deviation|Mean
1221357|NCT00726713|Secondary|Change From Baseline in Total Homocysteine at Week 16 and 24|To determine if Metanx® (compared to placebo) affects change in subjects total homocysteine levels|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks||||µmol/L||Standard Deviation|Mean
1221706|NCT00724815|Secondary|Phonophobia Free at Two Hours|Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
1221358|NCT00726713|Secondary|(Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24|The Hospital Anxiety and Depression Scale (HADS) consists of a 14-item questionnaire that provides a measurement of depression. Each item is rated on a 4-point scale, giving a maximum scores of 21 for the most severe depression. Depression was evaluated using the Hospital Anxiety and Depression Scale (HADS) question inventory at Baseline, and 24-week evaluation visits|HADS Scores scores were taken at 0 (Baseline) and 24 weeks||||units on a scale (0-21)||Standard Deviation|Mean
1221359|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory marker levels, including IL-6 and TNF-α|Analyte levels were taken at 0 (Baseline) and 24 weeks||||pg/mL||Standard Deviation|Mean
1221360|NCT00726713|Secondary|Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24|"To determine if Metanx® (compared to placebo) affects a subject’s lower extremity pain level using a 10-point Visual Analog Scale at Baseline and 24-week evaluation visits.~The Visual Analog Scale (VAS) measures a patients sensation of pain. A 10-cm visual analog scale is used. A measurement on the 10 cm analog scale is used to quantify the level of pain indicated with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable."|VAS scores were taken at 0 (Baseline) and 24 weeks||||units on a scale (0-10)||Standard Deviation|Mean
1221361|NCT00726713|Secondary|Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24|"To determine if Metanx® (compared to placebo) affects a subject’s “quality of life” as determined by the SF-36 questionnaire~The Short Form- 36 Mental Component Summary (SF-36 MCS) and SF-36 Physical Component Summary (SF-36 PCS) both measure health related quality of life, the MCS quantifying mental health and the PCS quantifying physical function. They are both scored on 100 point scales with 0 representing the worst possible outcome and 100 representing the most optimal possible scoring"|SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks||||units on a scale (0-100)||Standard Deviation|Mean
1221362|NCT00726713|Secondary|Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24|To determine if Metanx® (compared to placebo) affects a change in subject's total folate and total methyl malonic acid (MMA) at week 16 and 24|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks||||nmol/L||Standard Deviation|Mean
1221363|NCT00726713|Secondary|Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24|"This outcome was taken to determine if Metanx® (compared to placebo) has an effect on clinical examination as determined by the Neuropathy Disability Score (NDS)~The Neuropathy Disability Score (NDS) evaluates the severity of individual symptoms of neuropathy. A simple visual numeric distress scale is used that ranges from 0 to 10. The most favorable score is 0, which indicates an absence of symptoms. The most severe symptoms possible would be recorded as a score of 10."|NDS scores were taken at 0 (Baseline), 16, and 24 weeks||||units on a scale (0-10)||Standard Deviation|Mean
1221364|NCT00726713|Secondary|Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)|"This measure was taken to determine if Metanx® (compared to placebo) changes neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)~The Neuropathy Total Symptom Score-6 Scale (NTSS-6) is a validated scale that evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN). This scale was a modified 6 item scale that consists of yes or no questions. Scores range between 0 and 21.96, a higher score indicates greater severity of symptoms. After adjusting for baseline measurements scores are reflected as negative numbers. Negative numbers indicate improvement in symptoms. ie. a change from baseline after 24 weeks of -2 would be a greater improvement than a change in baseline of -1 after 24 weeks."|NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks||||units on a scale (0-6)||Standard Deviation|Mean
1221365|NCT00726713|Primary|Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks|Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes.|VPT was measured a 0 (baseline), and 24 weeks||||volts||Standard Deviation|Mean
1221366|NCT00726661|Secondary|Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy|All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
1221367|NCT00726661|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
1221368|NCT00726661|Secondary|Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation|Participants were assessed quarterly for progressive events and treatment status.|Approximately 4.5 years|All enrolled participants in Hormonal Therapy Cohort were considered for this outcome measure. n = number of participants evaluated at that particular time point.|||participants|||Number
1221493|NCT00725608|Secondary|Dosing of Suboxone (Buprenorphine Plus Naloxone)|One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.|day 1, month 6, month 12|All participants with eligible datasets were included in the final analysis|||Dose of Suboxone® in mg||Standard Deviation|Mean
1221369|NCT00726661|Secondary|Number of Participants With Tumor Response|The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
1221370|NCT00726661|Secondary|Overall Survival|Overall survival was defined as the time from enrolment to death of any cause.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
1221371|NCT00726661|Primary|Progression Free Survival|Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
1221372|NCT00726622|Secondary|Bowel and Stoma Function||Up to 5 years post surgery|||||||
1221373|NCT00726622|Secondary|Bowel Function||Up to 5 years post surgery|||||||
1221374|NCT00726622|Secondary|Quality of Life and Sexual Function||Up to 5 years post surgery|||||||
1221375|NCT00726622|Secondary|Overall Survival||Up to 5 years post surgery|||||||
1221376|NCT00726622|Secondary|Local Pelvic Recurrence Rates||Up to 2 years post surgery|||||||
1221377|NCT00726622|Secondary|Disease-free Survival||Up to 2 years post surgery|||||||
1221378|NCT00726622|Secondary|Operative Times|Open to close operative time.|During surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||minutes||Standard Deviation|Mean
1221379|NCT00726622|Secondary|Use of Pain Medication|The number of days patients received parenteral narcotics post-surgery were counted.|Two weeks post-surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||days||Standard Deviation|Mean
1221380|NCT00726622|Secondary|Length of Stay|The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.|Two weeks post-surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||days||Standard Deviation|Mean
1221381|NCT00726622|Secondary|Circumferential Margin > 1 mm|The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1221382|NCT00726622|Secondary|Negative Distal Resected Margin|The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binomial 95% confidence intervals.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1221383|NCT00726622|Secondary|Completeness of Total Mesorectal Excision (Complete or Nearly Complete)|"Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.~The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI."|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1221384|NCT00726622|Primary|Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.|"The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation.~Primary endpoint parameters:~Circumferential margin > 1 mm~Negative distal margin~Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat.~All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior."|At time of Surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1221497|NCT00725543|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||mg/kg||Full Range|Median
1221385|NCT00726609|Primary|Number of Participants Reporting Adverse Drug Reactions.|"The severity of an Adverse Drug Reaction is determined on the basis of the following definitions:~Mild: The abnormality, symptom or event is noticed but well tolerated.~Moderate: Symptoms impair normal activities and may require intervention.~Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required."|Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.||||Participants|||Number
1221386|NCT00726557|Primary|Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week|Tolerability of the treatment was measured by number of participants with complete treatment.|Assessed at the end of treatment|All enrolled participants|||participants|||Number
1221387|NCT00726557|Primary|Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions|Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).|End of Follow-up (Week 48 or Week 72, depending on genotype)|Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)|||Participants|||Number
1221388|NCT00726453|Secondary|Stent Thrombosis (ST)|Stent Thrombosis (ST) (as determined by historic and ARC definitions).|12 months||||percentage of participants|||Number
1221389|NCT00726453|Secondary|Target Vessel MI|Target Vessel MI (as determined by extended historical and ARC definitions).|12 months||||percentage of eligible participants|||Number
1221390|NCT00726453|Secondary|Death||12 months||||percentage of participants|||Number
1221391|NCT00726453|Secondary|Major Adverse Cardiac Event (MACE)|Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).|12 months||||percentage of participants|||Number
1221392|NCT00726453|Secondary|Target Vessel Failure (TVF)|Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).|12 months||||percentage of participants|||Number
1221393|NCT00726453|Primary|Target Lesion Failure (TLF)|Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.|12 Months||||percentage of participants|||Number
1221394|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Quinine Sulfate|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng-hr/mL||Standard Deviation|Mean
1221395|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Quinine Sulfate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng-hr/mL||Standard Deviation|Mean
1221396|NCT00726414|Primary|Maximum Plasma Concentration (Cmax) for Quinine Sulfate|The maximum or peak concentration that Quinine Sulfate reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1221397|NCT00726375|Secondary|The Number of Patients in Complete Remission (CR) at Four Weeks.|"Estimate the proportion of patients in complete remission (CR) at four weeks who remain alive and never require additional therapy four weeks after the last dose of etanercept.~Complete remission is defined as the resolution of all manifestations of GVHD (Graft Versus Host Disease) within the first four weeks of treatment. All organs must have a Grade 0."|28 days||||patients|||Number
1221398|NCT00726375|Primary|The Percentage of Patients Who Progress Within 28 Days of Initiation of Etanercept Treatment|We hypothesized that treatment of grade 1 acute GVHD (Graft Versus Host Disease) with etanercept would reduce the proportion of patients who progressed to grade 2 to 4 acute GVHD within 4 weeks of diagnosis from 58%, historically observed at our institution, to 38%.|28 days||||percentage of patients|||Number
1221399|NCT00726323|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, and Deaths|Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 4 years|Safety population|||Participants|||Number
1221400|NCT00726323|Secondary|Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case)|CTCAE gradation The worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for hemoglobin, leukocytes, platelets, percentage of lymphocytes, and percentage of neutrophils.|Up to 4 years|Safety population|||Participants|||Number
1221401|NCT00726323|Secondary|Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period|The worst case overall common terminology criteria for adverse events (CTCAE) grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases (ALT), aspartate aminotransferases (AST), Albumin, alkaline phosphatase (ALP), calcium, sodium, potassium, glucose, amylase, carbon dioxide, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. High (H) levels and low (L) levels were measured.|Up to 4 years|Safety population|||Participants|||Number
1221402|NCT00726323|Secondary|Overall Survival|Overall survival, which is defined as the time between the date of first dose of study drug and the date of death (due to any cause). For participants who were alive at the time of data cutoff, duration of overall survival was right censored at the date of last contact. Duration of overall survival = date of death/censoring - date of first dose +1. Percentiles and confidence intervals are calculated using Kaplan-Meier methods.|Up to 4 years|Safety population|||Months||95% Confidence Interval|Median
1221403|NCT00726323|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as the time between the date of first dose of study drug and the date of the first occurrence of one of the tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to disease progression, or disease progression as documented on the follow-up participants status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of stable disease was right censored at the date of the last available tumor measurement.|Up to 4 years|Safety population. All participants with Best overall response, not progressive disease were considered.|||Months||95% Confidence Interval|Median
1221404|NCT00726323|Secondary|Duration of Response (DOR)|Duration of response is defined as the time between the date of first response (later confirmed CR or confirmed PR) and the date of the first occurrence of one of the events as tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to any cause, disease progression as documented on the follow-up or participant status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of response was censored at the date of the last available tumor measurement.|Up to 4 years|Safety Population- All Objective Responders (those who did not reach an event by the time of data cut-off as defined in protocol)|||Months||95% Confidence Interval|Median
1221405|NCT00726323|Secondary|Time to Response (TTR) Over Period|Time to response is the time between the date of first dose of study drug and the date of first response (for participants who had overall responses that were later confirmed as CR/PR). For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the time to response was censored at the date of the last visit. The median time to response was not estimable in either of the dosing cohorts or in the overall safety population using the Kaplan-Meier method.|Up to 4 years|Safety population|||Months||95% Confidence Interval|Median
1221406|NCT00726323|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the time between the date of first dose of study drug and the date of the first occurrence of either tumor progression per RECIST or clinical assessment of progression as assessed by Investigator or Death due to any cause, whichever occurs the first. For participants who did not reach an event (disease progression or death) at the time of data cutoff, PFS was censored at the date of the last available tumor measurement. For participants who did not have any post-baseline tumor assessments, PFS was right censored at Day 1. For any participants who received subsequent anticancer therapy, PFS was right censored at the date of last adequate tumor assessment on or prior to the date of anticancer initiation. For any participants, who died or progressed after an extended follow-up, PFS was censored at the date of last adequate assessment prior to the extended loss to follow-up.|At the end of forth year|Safety population|||Months||95% Confidence Interval|Median
1221407|NCT00726323|Secondary|Disease Stabilization Rate Over Period|The percentage of participants for whom the best overall response was a confirmed PR, confirmed CR, or stable disease. Exact confidence intervals were obtained using the Clopper-Pearson method. Exact confidence intervals were obtained using the Clopper-Pearson method.|Up to 4 years|Safety population|||Percentage of participants||95% Confidence Interval|Number
1221408|NCT00726323|Primary|Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0|Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator’s assessment of the target and non target lesions.|At the end of forth year|The Safety population included all participants who passed the screening criteria, were enrolled in the study and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1221409|NCT00726232|Secondary|Change From Baseline to Week 4 in Health-related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 4 (Cycle 2, Day 1)|Intent to treat population.|||units on a scale||Standard Deviation|Mean
1221410|NCT00726232|Secondary|Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.~For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness."|Baseline and Week 4 (Cycle 2, Day 1)|Essential Thrombocythemia intent to treat population who had symptom scores > 0 at baseline and for whom data was available.|||participants||Standard Deviation|Mean
1221494|NCT00725608|Primary|Retention Rate|The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study|month 6, month 12|All eligible datasets were included in analysis population.|||percentage of patients||95% Confidence Interval|Number
1221411|NCT00726232|Secondary|Change From Baseline to Week 4 in Polycythemia Vera Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.~For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats."|Baseline and Week 4 (Cycle 2, Day 1)|Polycythemia Vera intent to treat population who had symptom scores > 0 at baseline for whom data was available.|||scores on a scale||Standard Deviation|Mean
1221412|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 36 weeks (Cycle 10, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1221413|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 24 weeks (Cycle 7, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1221414|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 4 weeks (Cycle 2, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1221415|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 36 (Cycle 10, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1221416|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 24 (Cycle 7, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1221417|NCT00726232|Primary|Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.~Complete Clinical Response:~Platelet count < 400 x 10^9/L~White blood cell count < 10 x 10^9/L with normal differential and Hematocrit ≤ upper limit of normal~Absence of sustained (> 2 weeks) anemia or leucopenia based on institutional normal ranges~Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias)~Absence of palpable splenomegaly~Partial Clinical Response:~Platelet count < 400 x 10^9/L~50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3.|Essential thrombocythemia intent to treat population, including all patients who took at least 1 dose of study drug. One patient in the 50 mg QD group did not have a response assessment at Cycle 3, Day 1.|||percentage of participants|||Number
1221418|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 12 (Cycle 4, Day 1)|Polycythemia Vera intent to treat population for whom data was available.|||percentage of participants|||Number
1221419|NCT00726232|Primary|Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.~CR:~Hematocrit < 45% in men and < 42% in women~No phlebotomy for 1 month~No palpable splenomegaly~White blood cells < 10 x 10^9/L with normal differential and platelets < 400 x 10^9/L~No sustained leucopenia or thrombocytopenia (>2 weeks)~No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss)~PR:~Hematocrit < 45% in men and < 42% in women~50% reduction in phlebotomy requirements from 6 months before treatment started~50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3|Polycythemia Vera intent to treat population, including all patients who took at least 1 dose of study drug.|||percentage of participants|||Number
1221420|NCT00726180|Primary|Standard Immunohistochemistry and Allred Scores Were to be Used to Measure the Estrogen Receptor (ER) Response Rate in Patients With ER-negative/Low, and Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-positive Breast Cancer.||90 days|Only 1 patient was enrolled to this study, so no data was obtained.||||||
1221421|NCT00726063|Secondary|Prosthesis Survival and Procedural Success||3 years||2018-12-31|12/2018||||
1221422|NCT00726063|Primary|Integration Success of the Implant||1 year|Number of implants surviving (lack of mobility) at the end of the study (time of analysis)|||implants|Implants||Number
1221423|NCT00726037|Secondary|Optimal Time for Future Dendritic Cell Vaccine Administration|The goal is to define the optimal time with 95% sensitivity and 95% specificity for future dendritic cell vaccine administration|33 Days|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption||||||
1221424|NCT00726037|Primary|T-reg Suppression From a Fractionated Dose of Ontak in Patients With Metastatic Pancreatic Cancer|The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.|days 8, 12 ,19,26 and 33 post administration|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption||||||
1221425|NCT00725985|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Number of participants with AEs includes number of participants with both serious adverse events (SAEs) and non-SAEs.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo) and had at least one safety assessment during the ITP.|||Participants|||Number
1221426|NCT00725985|Secondary|Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, new or enlarging T2 lesions, and new or persisting T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Lesions||Standard Deviation|Mean
1221427|NCT00725985|Secondary|Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS|The McDonald criteria use dissemination in time and space established by magnetic resonance imaging (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium enhanced (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions. Kaplan-Meier estimates were provided for the cum. % of participants with McDonald MS over time.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Cum. % of participants with McDonald MS|||Number
1221428|NCT00725985|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS|Clinically definite multiple sclerosis (CDMS) according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (>=) 1 point if baseline EDSS was between >= 1.0 and less than or equal to (=<) 4.5; or >= 1.5 points if baseline EDSS was 0, or >= 0.5 if baseline EDSS >= 5.0 over a period of at least 3 months. Kaplan-Meier estimates were provided for of the cumulative (cum.) percentage (%) of participants with CDMS over time. The probability of patients remaining event-free over time (from randomization) in each of the three treatment groups was displayed in the form of survival curves estimated using the non-parametric Kaplan-Meier method.|Baseline up to Week 96|The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Cum. % of participants with CDMS|||Number
1221429|NCT00725959|Secondary|Condom and Abstinence Norms, Attitudes, Self-efficacy and Intentions||two months|||||||
1221430|NCT00725959|Primary|Proportion of Condom Usage|number of times condom used divided by number of times person had sex in past 60 days|two months||||proportion of condom use||95% Confidence Interval|Mean
1221431|NCT00725920|Primary|Clinician Administered Posttraumatic Stress Disorder Scale|"The Clinician-Administered PTSD Scale (CAPS) [33] : is a structured interview developed to diagnose PTSD and rate its severity. It is comprised of 30-items to assess PTSD-related symptom frequency and severity. Total scores (sum of 3 clusters items) range from 0 to 136, with scores classified as follows: subclinical, from 0 to 19; mild, from 20 to 39; moderate, from 40 to 59; severe, from 60 to 79; extreme, 80 and above.~CAPS has 3 subscales characterized by the sum of all symptoms for each cluster: CAPS 1 (Revivesce/intrusive recolllections, 5 symptoms, score range: 0-28); CAPS 2 (avoidance, 7 symptoms, score range: 0-36); and CAPS 3 (hyperarousal, 5 symptoms, score range: 0-28).~CAPS scoring: each symptom scores range from 0 to 4, plus 0-2 scores for frequency, and 0-2 severity."|12 week||||Total CAPS score||Standard Deviation|Mean
1221432|NCT00725842|Secondary|Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.|72 weeks post EOT|77 of 90 participants had a negative HCV-RNA at Week 24 post EOT. These 77 were then evaluated for relapse at Week 72 post EOT.|||participants|||Number
1221433|NCT00725842|Secondary|Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response|Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.|Baseline and 24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.||||||
1221434|NCT00725842|Secondary|Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment|Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.|24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.||||||
1221495|NCT00725543|Primary|Median Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Full Range|Median
1221496|NCT00725543|Primary|Mean Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Standard Deviation|Mean
1221435|NCT00725842|Primary|Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.|24 weeks post end of treatment (EOT)|Of the 97 participants who started the study, 7 were excluded from analysis because of protocol violations. 90 participants underwent HCV-RNA testing at Week 24 post EOT.|||participants|||Number
1221436|NCT00725764|Secondary|Apparent Volume of Distribution|Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). Data for apparent volume of distribution was not derived as pharmacokinetic analysis was not completed. Data was not collected for PK analysis.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1221437|NCT00725764|Secondary|Apparent Oral Clearance|Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). Data for apparent oral clearance was not derived as pharmacokinetic analysis was not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1221438|NCT00725764|Secondary|Elimination Half-life (t1/2) of Foretinib in Participants With SCCHN|t1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1221439|NCT00725764|Secondary|Area Under the Concentration-time Curve (AUC) of Foretinib in Participants With SCCHN|AUC was defined as area under the plasma concentration vs. time curve. Blood samples were planned to be collected on time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1221440|NCT00725764|Secondary|Time to Maximum Plasma Concentration (Tmax) of Foretinib in Participants With SCCHN|tmax was defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. Blood samples were planned to be obtained during the time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1221441|NCT00725764|Secondary|Maximum Plasma Concentration (Cmax) of Foretinib in Participants With Squamous Cell Carcinoma of the Head and Neck (SCCHN)|Plasma samples for pharmacokinetic analysis were planned to be drawn at time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing) of each treatment cycle, however these analyses were not completed. Cmax was defined as maximal measured plasma concentration over the time span specified. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1221442|NCT00725764|Secondary|Percentage Participants With Disease Stabilization Rate|Disease stabilization rate was defined as the proportion of participants for whom the best overall response was a PR, CR, or stable disease. percentage participants with disease stabilization rate were presented.|Approximately up to 1 year|Safety Population|||percentage of participants||95% Confidence Interval|Number
1221443|NCT00725764|Secondary|Duration of Stable Disease|Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Duration of stable disease was defined as the time between the date of first dose of study drug and the first occurrence of 1 of the events: Tumor progression per RECIST as assessed by the investigator, Termination of study drug because of disease progression, Death due to disease progression, Disease progression as documented on the participant follow-up status form, Initiation of subsequent anticancer therapy.|Approximately up to 1 year|Safety Population. Analysis set included only participants whose best overall response was not disease progression.|||Months||Full Range|Median
1221444|NCT00725764|Secondary|Duration of Overall Survival|Overall survival was defined as the duration from the date of the first dose to the date of death. The start of a confounding anticancer therapy was treated as a censoring event. Every effort made to follow participant’s until death. Time to death was censored at the date of the latest participant contact or at the analysis cutoff date, if earlier. Kaplan-Meier method was used to estimate the overall survival distribution.|Approximately up to 1 year|Safety Population.|||Months||Full Range|Median
1221445|NCT00725764|Secondary|Duration of Progression-free Survival|Progression-free survival was defined as the duration from the date of first dose to the date of disease progression or date of death without documented progression or date of study termination + 1. The start of confounding anticancer therapy was not treated as a censoring event. Time to progression or death was censored at the study termination date or at the analysis cutoff date, if earlier.|Approximately up to 1 year|Safety Population.|||Months||Full Range|Median
1221446|NCT00725764|Primary|Number of Participants With Abnormalities in Urinalysis|Urinalysis parameters like appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood were performed. Number of participants with abnormalities are reported. In case of no abnormalities observed then it is reported as zero.|Week 5 [Day 29]|Safety population.|||Participants|||Count of Participants
1221458|NCT00725725|Secondary|Change in Anxiety Sensitivity Index (ASI) Score|The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had ASI scores at Screening and EOT.|||ASI Score||Standard Deviation|Mean
1221447|NCT00725764|Primary|Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology)|The National Cancer Institute -CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. Number of participants with abnormalities of CTCAE grade 3 in clinical chemistry parameters: alanine aminotransferase (ALT), γ-glutamyl transferase (GGT), phosphate, low sodium and hematology parameters: Leukocyte and Lymphocytes were presented.|Up to 20 months|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1221448|NCT00725764|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 20 months|Safety Population.|||Participants|||Count of Participants
1221449|NCT00725764|Primary|Percentage of Participants With Objective Response Rate (ORR)|ORR was defined as the proportion of participants achieving best overall response of confirmed CR or PR divided by the total number of participants who received treatment. Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Participants were evaluated for tumor response per RECIST. Percentage of participants with ORR were reported.|Approximately up to 1 year|Safety Population.|||Percentage of participants||95% Confidence Interval|Number
1221450|NCT00725764|Primary|Number of Participants Achieving Best Overall Response|Best overall response was assessed by the investigator per response evaluation criteria in solid tumors (RECIST). Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Tumor size was recorded at Baseline, and tumor response were recorded approximately every 8 weeks. Tumor response were classified by the investigator using RECIST criteria participant’s best response whether observed in the study treatment period or the treatment extension period was considered. The best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Number of participants who achieved best overall response were recorded.|Approximately up to 1 year|safety population comprised of all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.|||Participants|||Count of Participants
1221451|NCT00725751|Secondary|Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy|This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.|Day 1|Participants who received at least one dose of antiviral treatment.|||participants|||Number
1221452|NCT00725751|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)|All treated participants.|||participants|||Number
1221453|NCT00725751|Primary|Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin|For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 to 48 weeks|Participants who received at least one dose of PegIFN-2b/ribavirin|||participants|||Number
1221454|NCT00725725|Secondary|Number of Participants Discontinuing Study Therapy Due to AEs|The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 2 weeks|All treated participants are included in the safety analysis.|||Participants|||Number
1221455|NCT00725725|Secondary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 59 days|All treated participants are included in the safety analysis.|||Participants|||Number
1221456|NCT00725725|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|"The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 (very poor) to 5 (very good), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life)."|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had Q-LES-Q scores at Screening and EOT.|||Q-LES-Q Score||Standard Deviation|Mean
1221457|NCT00725725|Secondary|Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score|The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had MADRS scores at Screening and EOT.|||MADRS score||Standard Deviation|Mean
1221459|NCT00725725|Secondary|Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score|The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SIGH-A scores at Screening and EOT.|||SIGH-A Score||Standard Deviation|Mean
1221460|NCT00725725|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score|The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had CGI-S scores at Screening and EOT.|||CGI-S Score||Standard Deviation|Mean
1221461|NCT00725725|Secondary|SCID-I/P With Psy Screen Score at EOT|The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at EOT.|||Participants|||Number
1221462|NCT00725725|Secondary|Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening|The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with [w] or without [w/o] AGP) as being current (full criteria for the disorder met), in full remission (IFR) [there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder], or in partial remission (IPR) [full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Screening|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at Screening.|||Participants|||Number
1221463|NCT00725725|Secondary|Change in PDSS Score From Baseline to Follow-Up|The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Follow-Up (Day 59)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS scores at Screening and Follow-Up.|||PDSS Score||Standard Deviation|Mean
1221464|NCT00725725|Secondary|Change in PDSS Score From Baseline to Visit 4|The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Visit 4 (Day 22)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and PDSS scores at Screening and Visit 4.|||PDSS Score||Standard Deviation|Mean
1221465|NCT00725725|Primary|Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)|The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Day 36|The Intent-to-Treat (ITT) population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS assessments at Screening and EOT.|||PDSS Score||Standard Deviation|Mean
1221466|NCT00725712|Secondary|Median Duration of Overall Survival (OS)of GSK1363089|Duration of OS is defined as (Date of Death [due to any cause]) minus Date of first dose. For the participants who were alive at the time of data cut-off, duration of overall survival was censored at the date of last contact. The upper value of the full range was censored observation.|At every 8 Weeks upto 31 months|Evaluable population|||months||Full Range|Median
1221467|NCT00725712|Secondary|Disease Stabilization Rate of GSK 1363089|It is defined as the number of participants achieving best overall response of confirmed CR or PR or stable disease (SD). It was assessed using RECIST criteria 1.0. The CR for target lesions was defined as disappearance of all TLs and the NTLs. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference, the smallest sum LD since the treatment started.|At every 8 Weeks upto 31 months|Safety population|||percentage of participants||95% Confidence Interval|Number
1221468|NCT00725712|Secondary|Duration of Stable Disease of GSK1363089|Duration of stable disease, was defined as the time between the date of first dose and death or disease progression, in participants whose best overall response was not progressive disease|At every 8 Weeks upto 31 months|Evaluable population. Only those participants available at the specified time-points were analyzed.|||months||95% Confidence Interval|Median
1221479|NCT00725712|Primary|Change From Baseline in Vital Signs-Systolic and Diastolic Blood Pressure|Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The data for minimum (min) and maximum (max) post-baseline has been reported. Baseline is defined as the last non-missing record on or before first dose.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1221469|NCT00725712|Secondary|Median Progression Free Survival (PFS) of GSK1363089|Duration of PFS in months is defined as (Date of Disease Progression/Death - Date of First Dose + 1)/30.44. For participants who did not reach an event (disease progression or death) at the time of data cut-off, duration of PFS is censored at date of last available tumor assessment that is not 'Unable to Evaluate'. For participants who did not have any post-baseline tumor assessments, PFS was censored at Day 1. For any participants who received subsequent anti-cancer therapy, PFS will be right censored at the date of last adequate tumor assessment on or prior to the date of anti-cancer therapy initiation. For any participants who died or progressed after an extended lost-to-follow-up time (greater than 17 weeks), PFS was censored at the date of last adequate assessment prior to extended lost-to follow-up.|At every 8 Weeks upto 31 months|Safety population|||months||95% Confidence Interval|Median
1221470|NCT00725712|Primary|Number of Participants Who Required Concomitant Medications|The number of participants who received concomitant medication during the study were reported. The data has been reported for the participants who have received subsequent chemotherapy, subsequent radiation therapy or other therapy.|Baseline (pre-dose) and before 30-day follow- up (up to 2 years)|Safety population.|||Participants|||Count of Participants
1221471|NCT00725712|Primary|Number of Participants With Shift From Baseline by Grade for Hematology Parameters|The worst overall grading by CTCAE version 3.0, was used to report the shift from baseline for hematology parameters namely hemoglobin, platelets and lymphocytes. The grades were namely G0, G1, G2, G3 and G4. The data for shifts from G2 to G3 and G0 to G4, mainly the shifts to higher grades G3 and G4 have been reported.|Baseline (pre-dose) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1221472|NCT00725712|Primary|Number of Participants With Grade Shift for Urinalysis Parameters|The urinalysis parameters by worst case overall CTCAE grade shift post Baseline for each parameter were mentioned as per the CTCAE grading for version 3.0 and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for abnormal values for bilirubin, ketones, nitrites, occult blood, pH, protein, specific gravity, and urobilinogen.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified timepoints were reported.|||participants|||Number
1221473|NCT00725712|Primary|Number of Participants With Shift From Baseline by High/Low Flag for Hematology Paramaters|The hematology parameters worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. CTCAE grading for version 3.0 was used and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for basophils, eosinophils, erythrocytes, hematocrit, and monocytes were analyzed. Only the abnormal values were reported where normal to high and normal to low changes were reported. Worst Overall was defined as highest post baseline CTCAE grade before 30 day follow up.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1221474|NCT00725712|Primary|Number of Participants With Shift From Baseline in Serum Chemistry- Graded|The worst overall common terminology criteria for adverse events version 3.0 (CTCAE) grade (G) shift post baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading is done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases, aspartate aminotransferases, Albumin, alkaline phosphatase, calcium, sodium, potassium, glucose, amylase, amylase, bilirubin, creatinine, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. Worst Overall defined as worst post baseline out of normal range flag in the order of (high, low, normal) before 30 day follow up. Data for G3 and G4 is reported.|From Day 1 to up to 30-day follow-up visit (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed .|||Participants|||Count of Participants
1221475|NCT00725712|Primary|Number of Participants With Shift From Baseline in by High/Low Flag for Serum Chemistry- Ungraded|The data for serum chemistry parameters like albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), amylase, aspartate amino transferase (AST), calcium, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, blood urea nitrogen (BUN), chloride, free thyroxine, free triiodothyronine, lipase, phosphorous, potassium, sodium, total bilirubin, lactate dehydrogenase, total protein. The abnormal values have been reported wherein data for normal to low and normal to high has been reported.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points we re analyzed.|||participants|||Number
1221476|NCT00725712|Primary|Change From Baseline in Respiratory Rate (RR)|The RR for the participant’s, were collected after the participant sat quietly for at least five minutes. Baseline evaluations should be performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1 . The RR was measured in breaths per minute. Min and max post-baseline values are reported.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time-points were analyzed.|||breaths per minute||Standard Deviation|Mean
1221477|NCT00725712|Primary|Change From Baseline in Temperature|The body temperature for the participants was assessed. These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline is defined as the last non-missing record on or before first dose.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||degree celsius||Standard Deviation|Mean
1221478|NCT00725712|Primary|Change From Baseline in Vital Signs-Pulse Rate|The pulse rate or heart rate (HR) for the participant’s, were collected after the participant sat quietly for at least five minutes. Baseline evaluations were performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1. The HR was measured in beats per minute (bpm). The min and max values have been reported.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
1221480|NCT00725712|Primary|Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered SAEs if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 31 months|Safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.|||participants|||Number
1221481|NCT00725712|Primary|Number of Participants With Objective Response Rate (ORR), of GSK1363089, Per- Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0|ORR is defined as the percentage of participants achieving best overall response of confirmed complete response (CR) or partial response (PR). Tumor response for participants with measurable lesions was assessed routinely (after 8 weeks of treatment and approximately every 8 weeks thereafter) using RECIST (version 1.0) criteria. The CR for target lesions was defined as disappearance of all target lesions (TLs) and the non-target lesions (NTLs). PR defined as at least 30% decrease in sum of the longest diameter (LD) of TLs, taking as reference baseline sum LD. The safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug. Progressive disease will be used as PD.|At every 8 Weeks upto 31 months|Evaluable population included participants from safety population who had received atleast 75% of protocol mandated doses at treatment period, had BL and post BL tumor assessment, with no extended lost to followup (17 wks or more) or who had received atleast 75% of protocol mandated doses at treatment period and discontinued study drug due to PD.|||participants|||Number
1221482|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.|||Score on a scale||Standard Deviation|Mean
1221483|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.|||Score on a scale||Standard Deviation|Mean
1221484|NCT00725621|Primary|Median Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Full Range|Median
1221485|NCT00725621|Primary|Mean Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Standard Deviation|Mean
1221486|NCT00725621|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||mg/kg||Full Range|Median
1221487|NCT00725621|Secondary|Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)|Some participants had more than one previous treatment with a DMARD.|24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.|||Participants|||Number
1221488|NCT00725621|Secondary|Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy||24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.|||Years||Standard Deviation|Mean
1221489|NCT00725621|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
1221490|NCT00725621|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Full Range|Median
1221491|NCT00725621|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Standard Deviation|Mean
1221492|NCT00725608|Secondary|Dispensing of Suboxone (Buprenorphine Plus Naloxone)|Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)|month 6, month 12|All participants with eligible datasets were included in the final analysis|||Participants|||Number
1221498|NCT00725543|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
1221499|NCT00725543|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Full Range|Median
1221500|NCT00725543|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Standard Deviation|Mean
1221501|NCT00725530|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|7 days|All enrolled participants.|||Participants|||Number
1221502|NCT00725504|Primary|Present Pain Intensity|Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).|Patients completed the VAS of present pain intensity at each infusion level. Each infusion level took approximately one hour, and the assessment was done at the end of the hour (approximately 3 hours total).||||Score||Standard Error|Mean
1221503|NCT00725491|Primary|The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.|The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.|At completion of ovarian stimulation; maximally after 18 days of recFSH administration.|The number of participants for this analysis included only those participants in the intent-to-treat (ITT) group who received hCG and for whom data was available.|||international units (IU)||Standard Deviation|Mean
1221504|NCT00725452|Secondary|Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab|BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.|Baseline and Infusion 9|Infliximab-naive participants who received Infliximab during the study.|||Percent of BSA involved with psoriasis||Standard Deviation|Mean
1221505|NCT00725452|Secondary|Median Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.|||mg/kg||Full Range|Median
1221506|NCT00725452|Secondary|Mean Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
1221507|NCT00725452|Secondary|Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.|||Days||Full Range|Mean
1221508|NCT00725452|Secondary|Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.|||Days||Standard Deviation|Mean
1221509|NCT00725452|Primary|Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab|"The types of therapies were assessed according to the following criteria:~Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days).~Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks).~Episodic Therapy: given out of time frame (> 12 weeks)."|Maximum 2 years|Infliximab-naive participants who received Infliximab during the study.|||Therapies|||Number
1221510|NCT00725361|Secondary|Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline.|Range is 0-3 with 0 meaning the least amount of disability and 3 the greatest of disability.|24 weeks||||units on a scale||Standard Deviation|Mean
1221511|NCT00725361|Secondary|Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12.||12 weeks|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||Participants|||Count of Participants
1221512|NCT00725361|Secondary|Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12.||12 weeks|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||Participants|||Count of Participants
1221513|NCT00725361|Secondary|New DU 4 Weeks Prior to Week 12|The number of new DU that have developed in the preceding 4 weeks assessed at week 12 from baseline.|4 weeks prior to week 12|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||new digital ulcers||Standard Deviation|Mean
1221514|NCT00725361|Primary|New Digital Ulcers (DU) 4 Weeks Prior to Week 24|The number of new digital ulcers (DU) that have developed in the preceding 4 weeks assessed at week 24 from baseline.|4 weeks prior to week 24||||new digital ulcers||Standard Deviation|Mean
1221515|NCT00725322|Secondary|NRS Score Three Weeks After Injection|The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain.|Three weeks after injection|Although 27 participants completed the study, 3 participants were excluded from analysis of the NRS score because they had missing data.|||Units on a scale||Standard Deviation|Mean
1221516|NCT00725322|Primary|Time Until Analgesic Failure|Participants made daily NRS reports via Palm Pilot, and “failure” was defined as (Pre-injection baseline NRS) – (Mean NRS for any 3 preceding days) ≤ 0; or 9 months|Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline||||Days||Standard Deviation|Mean
1221517|NCT00725296|Primary|Median Dose of All Infusions Per Participant|The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.|||mg/kg||Full Range|Median
1221518|NCT00725296|Primary|Average Overall Dose of All Infusions Per Participant|The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.|||mg/kg||Standard Deviation|Mean
1221519|NCT00725296|Primary|Median Dose During Induction Therapy and Subsequent Maintenance Therapy|The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||mg/kg||Full Range|Median
1221520|NCT00725296|Primary|Average Dose During Induction Therapy and Subsequent Maintenance Therapy|The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||mg/kg||Standard Deviation|Mean
1221521|NCT00725296|Primary|Median Time Interval Between Infusions During Maintenance Therapy|The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||days||Full Range|Median
1221522|NCT00725296|Primary|Mean Time Interval Between Infusions During Maintenance Therapy|The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||days||Standard Deviation|Mean
1221523|NCT00725283|Secondary|Number of Patients With Serious Adverse Events Related to Study Treatment|Serious adverse events (SAEs) assessed include medical occurrences related to treatment administration that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the CRF, but not as an SAE.|During the whole study duration (From Day 0 up to the concluding visit, at Month 49)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
1221524|NCT00725283|Secondary|Number of Patients With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include any medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the Clinical Report Form (CRF), but not as an SAE.|During the whole study duration (From Day 0 up to the concluding visit, at Month 49)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
1221525|NCT00725283|Secondary|Number of Patients With Any Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-administration period|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
1221526|NCT00725283|Primary|Number of Patients With Anti-WT1 Antibody Response|"Treatment response was defined as:~For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/ML; For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration."|At Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||Participants|||Count of Participants
1221527|NCT00725283|Primary|Concentrations for Anti-WT1 Antibodies|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).|At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||EU/mL||95% Confidence Interval|Geometric Mean
1221528|NCT00725283|Primary|Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies|Seropostivity rate was defined as the number of patients with anti-WT1 antibody concentration greater than or equal to (≥) the cut-off value of 9 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).|At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||Participants|||Count of Participants
1221529|NCT00725283|Primary|Number of Patients With Severe Toxicities|"Severe toxicities (as classified according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0) during the study treatment period defined as a study product-related or possibly study product-related:~Grade 4 toxicity (exception: Grade 4 fatigue – including lethargy, asthenia, and malaise – had to have a duration of at least 48 hours to be taken into account).~Grade 3 toxicity lasting for at least 48 hours (exceptions: myalgia, arthralgia, headache, and fever, regardless of duration).~An allergic reaction/hypersensitivity Grade 2 toxicity (i.e., rash, flushing, urticaria, and dyspnea). Drug fever was not part of this definition.~Decrease in renal function, with a calculated creatinine clearance < 40 mL/min.~Grade 2 cardiac ischemia/infarction (i.e., asymptomatic and testing suggesting ischemia; stable angina)."|During the study treatment period (From Day 0 to Month 48)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
1221530|NCT00725270|Primary|Change in Mood Symptoms|Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63, with higher scores indicating greater levels of depression.|Baseline and Day 9||||units on a scale||Standard Deviation|Mean
1221531|NCT00725270|Primary|Change in Positive Psychotic Symptoms Over the Course of Treatment|Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms|8 days||||units on a scale||Standard Deviation|Mean
1221532|NCT00725205|Secondary|Number Of Participants Self-Administering Pegylated Interferon Alfa-2b|Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.|Up to 48 Weeks|All Participants enrolled.|||Participants|||Number
1221533|NCT00725205|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.|24 Weeks following completion of 24 or 48 weeks of therapy|Full Analyses Set: All enrolled participants who received any dose of any medication (Peginterferon or Ribavirin) and had a known viral genotype. Of the 294 enrolled participants, 2 were not treated.|||Participants|||Number
1221534|NCT00725205|Primary|Number of Participants Who Are Triple-80 Compliant|Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.|24 or 48 Weeks|"All enrolled participants who received any dose of any medication, had a known viral genotype, and did not discontinue from the study with the status being “treatment~failure”. Of the 294 enrolled participants, 253 participants started treatment and continued treatment beyond Week 12."|||Participants|||Number
1221535|NCT00725153|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|10 hours|All enrolled participants.|||Participants|||Number
1221536|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)|Participant productivity was described as the number of days a participant missed work due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1221707|NCT00724815|Secondary|Photophobia Free at Two Hours|Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
1221537|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)|Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1221538|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)|Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1221539|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)|Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1221540|NCT00725101|Secondary|Number of Days of Partial Care for Fibromyalgia (FM) Participants|Partial (day or night) care included day care, day nursing home, and partial hospitalization.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1221541|NCT00725101|Secondary|Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing ER visit values.|||ER visits||Standard Deviation|Mean
1221542|NCT00725101|Secondary|Number of Outpatient Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing outpatient visit values.|||outpatient visits||Standard Deviation|Mean
1221543|NCT00725101|Secondary|Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months|The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing SDS scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
1221544|NCT00725101|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months|FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing FIQ scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
1221545|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months|BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-S scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
1221546|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months|Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-I scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
1221547|NCT00725101|Secondary|Hazard Ratios for Factors Associated With Discontinued Opioid Use|Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.|Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.|||hazard ratio|||Number
1221548|NCT00725101|Secondary|Percentage of Participants Who Discontinued Opioids||Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.|||percentage of participants|||Number
1221549|NCT00725101|Secondary|Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study|Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.|Baseline through 12 months|The analysis population included participants who reported discontinuing medication at least once during the 12-month period post-baseline.|||participants|||Number
1221550|NCT00725101|Primary|Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use|Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity [not at all severe, severe for several days, severe for more than half the days, severe nearly every day]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.|||odds ratio||95% Confidence Interval|Number
1221551|NCT00725101|Primary|Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication|Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.|||odds ratio||95% Confidence Interval|Number
1221552|NCT00725101|Primary|Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months||Baseline through 12 months|The analysis population included enrolled participants who took part in all follow-up interviews.|||medications||Standard Deviation|Mean
1221553|NCT00725075|Secondary|Change From Baseline in Extrapyramidal Symptoms Rating Scale Score at Week 12|The abbreviated Extrapyramidal Symptoms Rating Scale (ESRS-A) was a sum of the severity rating of a 24-item instrument assessing four types of movement disorders: parkinsonism, dystonia, dyskinesia, and akathisia. Each item was rated on a 7-point scale, from 0=absent to 6=severe. Higher scores indicated more impairment. A negative change from baseline indicated an improvement.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy.|||Score on a Scale||Standard Deviation|Mean
1221554|NCT00725075|Secondary|Change From Baseline in Composite Memory Score at Week 12|Composite memory was a composite of verbal memory and visual memory and was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221555|NCT00725075|Secondary|Change From Baseline in Executive Functioning Score at Week 12|Executive functioning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Shifting Attention Test. The participant matched geometric shapes either by shape or color. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221556|NCT00725075|Secondary|Change From Baseline in Sustained Attention Score at Week 12|Sustained attention was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was asked to identify a target shape/color when presented with a battery of different geometric shapes/colors. Only Parts 2 to 4 of the 4 Part Continuous Performance Test contributed towards the sustained attention score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221557|NCT00725075|Secondary|Change From Baseline in Working Memory Score at Week 12|Working memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was presented with targets and remembered target presentation sequencing in order to respond to the directions. Only Part 4 of the 4 Part Continuous Performance Test contributed towards the working memory score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221558|NCT00725075|Secondary|Change From Baseline in Speed of Complex Information Processing Score at Week 12|Speed of complex information processing was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Symbol-digit Coding Test. The participant linked numbers to digits. The test consisted of serial presentations of screens, each containing a bank of 8 symbols above and 8 empty boxes below. The participant typed the number that corresponded to the symbol highlighted. The raw score was the processing time in milliseconds. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221559|NCT00725075|Secondary|Change From Baseline in Visual Memory Score at Week 12|Visual memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 geometric figures within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Sore on a Scale||Standard Deviation|Mean
1221560|NCT00725075|Secondary|Change From Baseline in Verbal Memory Score at Week 12|Verbal memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 words within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221561|NCT00725075|Secondary|Change From Baseline in Non-Verbal Reasoning Score at Week 12|Non-verbal reasoning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant solved 15 visual analogies composed of geometric 2x2, 3x3, or 4x4 puzzles by choosing the most appropriate geometric figure that solved the matrix. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221562|NCT00725075|Secondary|Change From Baseline in Perception of Emotions Score at Week 12|Perception of emotion was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant identified different emotional states (happy, sad, angry, and calm [neutral]) presented in pictures of faces by choosing the appropriate word for the emotion. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221563|NCT00725075|Secondary|Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) at Week 12|CDSS was a 9-item clinician-rated instrument used to evaluate depression in participants who have schizophrenia. For each item, symptom severity was rated on a 4-point scale, from 0=absent to 3=severe, with a total scoring range of 0 to 27. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221564|NCT00725075|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Schizophrenia at Week 12|PANSS was a 30-item clinician-rated instrument used for assessing the positive, negative, and general psychopathology symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme, with a total scoring range of 30 to 210. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221565|NCT00725075|Primary|Change From Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS 1-22 Composite Score) at Week 12|SANS was a 25-item clinician-rated instrument for assessing the negative symptoms of schizophrenia. SANS 1-22 Composite Score consisted of the SANS 25 scale minus the last 3 questions (attention items). The remaining non-attention items (affective flattening, alogia, avolition-apathy, and anhedonia-asociality) comprised the SANS 1-22 Composite Score. For each item, symptom severity was rated on a 6-point scale, from 0=absent to 5=severe. The SANS 1-22 Composite Score had a total scoring range of 0 to 110. Higher scores indicated more impairment. The SANS 1-22 Composite Score was reported using data from the adjusted site rater. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1221566|NCT00725049|Secondary|Cost Analysis||3 years||2018-12-31|12/2018||||
1221567|NCT00725049|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.|3 years|Number of participants used in analysis selected as per protocol|||participants|Dental implants||Number
1221568|NCT00725010|Primary|Number of Participants Who Discontinued Due to Toxicity||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase||||Participants|||Number
1221569|NCT00725010|Primary|Safety: Number of Adverse Events in the Indicated Categories||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase||||Adverse Events|||Number
1221570|NCT00724984|Primary|Phase II: Overall Response Rate (CR+PR)||From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles||||Percentage of Participants||95% Confidence Interval|Number
1221571|NCT00724984|Primary|Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response|Number of patients experienced DLT in each cohort|From the Date of PCI-24781 first administration to Cycle 2 Day 1||||participants|||Number
1221572|NCT00724958|Primary|Total Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|315 of infliximab-naive participants were treated in the active phase of the study. Of these, 191 participants received induction therapy (Weeks 0, 2, and 6); 27 received only induction therapy, 132 received induction therapy and subsequent maintenance therapy, and 32 received induction therapy and subsequent episodic therapy.|||mg/kg||Standard Deviation|Mean
1221573|NCT00724958|Primary|Median Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||mg/kg||Full Range|Median
1221574|NCT00724958|Primary|Average Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||mg/kg||Standard Deviation|Mean
1221575|NCT00724958|Secondary|Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.|HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease).|5 years|207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI)|||Score on a scale||Standard Deviation|Mean
1221576|NCT00724958|Primary|Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||Days||Full Range|Median
1221577|NCT00724958|Primary|Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||Days||Standard Deviation|Mean
1221578|NCT00724945|Primary|Subject Vision|"Subjects responded to How would you rate the overall quality of vision with these study contact lenses using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent."|after 1 week wear||||Scores on a scale||Standard Error|Least Squares Mean
1221579|NCT00724945|Primary|Near Visual Acuity|This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.|after 1 week wear||||logMAR units||Standard Error|Least Squares Mean
1221580|NCT00724945|Primary|Distance Visual Acuity|This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal|after 1 week of wear|Analysis includes participants who completed the study per protocol.|||logMAR units||Standard Error|Least Squares Mean
1221581|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.|From signing of informed consent to end of trial (7 days after surgery)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1221582|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs|"An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.~Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration."|From signing of informed consent to end of trial (7 days after surgery)|The All-Subjects-Treated (AST) Population consisted of all randomized participants who received IMP.|||participants|||Number
1221583|NCT00724932|Other Pre-specified|Time From PACU Admit to Actual PACU Discharge|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From PACU admit to actual PACU discharge (up to ~4.3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221584|NCT00724932|Other Pre-specified|Time From PACU Admit to PACU Discharge Ready|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From PACU admit to PACU discharge ready (up to ~25 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221585|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to Actual PACU Discharge|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221586|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to PACU Discharge Ready|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221587|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual PACU Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221621|NCT00724893|Secondary|Number of Participants Achieving RVR by Gender (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1221588|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221589|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Actual Operating Room Discharge|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From tracheal extubation to actual OR discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221590|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Operating Room Discharge Ready|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From tracheal extubation to Operating Room discharge ready (up to ~1 minute)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221591|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Actual Operating Room Discharge|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221592|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Operating Room Discharge Ready|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221593|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Tracheal Extubation|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated.|From start of IMP administration to tracheal extubation (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221594|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to T4/T1 Ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90|The time of IMP administration was defined as the actual time at which IMP administration was started.|From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Data not collected. In Protocol Amendment 2, this outcome measure was removed.||||||
1221595|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual Operating Room Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221596|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Actual Operating Room Discharge|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room admission to actual Operating Room discharge (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221597|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Operating Room Discharge Ready|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place.|From Operating Room admission to Operating Room discharge ready (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1221598|NCT00724932|Other Pre-specified|Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study|Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial.|Up to 30 days after IMP administration|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1221599|NCT00724932|Other Pre-specified|Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites|The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site.|Up to PACU discharge (up to ~4.5 hours)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1221600|NCT00724932|Other Pre-specified|Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium|Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded.|Up to 7 days after IMP administration|The AST Population consisted of all randomized participants who received sugammadex. Participants who received neostigmine were excluded from this analysis.|||participants|||Number
1221601|NCT00724932|Other Pre-specified|Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)|Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring.|Up to 24 hours after IMP administration|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1221602|NCT00724932|Other Pre-specified|Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB.|Up to 30 minutes after IMP administration|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||participants|||Number
1221603|NCT00724932|Other Pre-specified|Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events|Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user.|From induction of anesthesia to recovery from NMB (up to ~3 hours)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1221604|NCT00724932|Other Pre-specified|Number of Participants Who Had Physical Examinations|Physical examinations were to be conducted at screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery).|At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP. As there was no specific physical examination case report form used in this study, data on whether or not a physical examination was conducted were not recorded.||||||
1221605|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.|||minutes||95% Confidence Interval|Geometric Mean
1221606|NCT00724932|Other Pre-specified|Mean Heart Rate|Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||beats per minute||Standard Deviation|Mean
1221607|NCT00724932|Other Pre-specified|Mean Diastolic Blood Pressure|Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||mm Hg||Standard Deviation|Mean
1221608|NCT00724932|Other Pre-specified|Mean Systolic Blood Pressure|Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||mm Hg||Standard Deviation|Mean
1221609|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group|The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered.|From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received neostigmine and had at least one efficacy measurement. The participants who received sugammadex were not included in this analysis.|||minutes||95% Confidence Interval|Geometric Mean
1221708|NCT00724815|Primary|Pain Free at Two Hours|Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
1221610|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group|The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered.|From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)|The ITT Population consisted of all randomized participants who received sugammadex and had at least one efficacy measurement. The participants who received neostigmine were not included in this analysis.|||minutes||95% Confidence Interval|Geometric Mean
1221611|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB.|From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times from administration of last dose of rocuronium to recovery of the T4/T1 ratio to 0.5, 0.6, 0.7, 0.8 and 0.9.|||minutes||95% Confidence Interval|Geometric Mean
1221612|NCT00724932|Other Pre-specified|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times to recovery of the T4/T1 ratio to 0.5 and 0.6.|||minutes||95% Confidence Interval|Geometric Mean
1221613|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.|||minutes||95% Confidence Interval|Geometric Mean
1221614|NCT00724932|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)|The Intent-To-Treat (ITT) Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
1221615|NCT00724893|Secondary|Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)|Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered “always” or “most of the time” to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants who completed the MAQ questionnaire during the study and achieved SVR|||percentage of participants|||Number
1221616|NCT00724893|Secondary|Number of Participants Achieving SVR by HIV Status (Stage 2)|"SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|This analysis was not done.||||||
1221617|NCT00724893|Secondary|Number of Participants Achieving EVR by HIV Status (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|This analysis was not done.||||||
1221618|NCT00724893|Secondary|Number of Participants Achieving RVR by HIV Status (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|This analysis was not done.||||||
1221619|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221620|NCT00724893|Secondary|Number of Participants Achieving EVR by Gender (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221622|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221623|NCT00724893|Secondary|Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221624|NCT00724893|Secondary|Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1221625|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221626|NCT00724893|Secondary|Number of Participants Achieving EVR by Weight (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221627|NCT00724893|Secondary|Number of Participants Achieving RVR by Weight (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprises 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1221628|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221629|NCT00724893|Secondary|Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221630|NCT00724893|Secondary|Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)|RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1221631|NCT00724893|Secondary|Number of Participants Achieving EVR Who Achieved SVR (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication and achieved EVR|||participants|||Number
1221632|NCT00724893|Secondary|Number of Participants Achieving RVR Who Achieved SVR (Stage 2)|RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Week 4|Participants who achieved RVR|||participants|||Number
1221633|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 2)|SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221634|NCT00724893|Secondary|Number of Participants Achieving EVR by Race (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221635|NCT00724893|Secondary|Number of Participants Achieving RVR by Race (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1221636|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221637|NCT00724893|Secondary|Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1221638|NCT00724893|Secondary|Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT population); no participants had Genotype 5|||Participants|||Number
1221639|NCT00724893|Secondary|Relapse Rate by HCV Genotype (Stage 1)|The relapse rate was calculated with these parameters: EOT “yes”, EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|"All participants who took at least one dose of study medication (ITT population) and had EOT yes and valid EVR evaluation ; no participants had Genotype 5"|||Percentage of Participants|||Number
1221640|NCT00724893|Secondary|Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Week 12|The EVR analysis population comprised participants with HCV genotypes 1, 4, and 6 only, who took at least one dose of study medication; no participants had Genotype 5|||Participants|||Number
1221641|NCT00724893|Secondary|Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)|EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as “not done” then EOT was set to “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||particpants|||Number
1221642|NCT00724893|Secondary|Number of Participants With End of Treatment (EOT) Response (Stage 1)|EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as “not done” then EOT was set to “no”.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
1221643|NCT00724893|Secondary|Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221644|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221645|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221646|NCT00724893|Secondary|Number of Participants Achieving SVR by EVR Type (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|The EVR analysis population comprised participants with HCV Genotypes 1, 4, 5, and 6 who took at least one dose of study medication. No participants had Genotype 5.|||participants|||Number
1221647|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|From Week 10 to Week 14|The EVR analysis population comprised participants with HCV Genotypes 1, 4, and 6 only, who took at least one dose of study medication.|||participants|||Number
1221648|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
1221649|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
1221650|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
1221651|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221652|NCT00724893|Secondary|Number of Participants Achieving SVR by Viral Load (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221653|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221654|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221655|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
1221656|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population).|||Participants|||Number
1221657|NCT00724893|Secondary|The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data|||participants|||Number
1221658|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data|||Participants|||Number
1221659|NCT00724893|Secondary|Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
1221660|NCT00724893|Secondary|Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
1221661|NCT00724893|Secondary|Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)|Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
1221662|NCT00724893|Secondary|Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221663|NCT00724893|Primary|Number of Participants Achieving SVR (Stage 2)|SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221664|NCT00724893|Primary|Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)|This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
1221665|NCT00724893|Primary|Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)|This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
1221666|NCT00724893|Primary|Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)|This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1221667|NCT00724867|Secondary|Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Percentage of Participants|||Number
1221668|NCT00724867|Secondary|Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
1221684|NCT00724867|Primary|Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Millimeters of mercury||Standard Deviation|Mean
1221669|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints|The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
1221670|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point|The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
1221671|NCT00724867|Secondary|Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points|Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change >0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Percentage of Participants|||Number
1221672|NCT00724867|Secondary|Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage change||Full Range|Median
1221673|NCT00724867|Secondary|Observed B-cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Cell count||Full Range|Median
1221674|NCT00724867|Secondary|Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with >= 50% reduction in proteinuria among participants with Baseline proteinuria >0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage of Participants|||Number
1221675|NCT00724867|Secondary|Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.|Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage of Participants|||Number
1221692|NCT00724867|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Grams per liter||Standard Deviation|Mean
1221676|NCT00724867|Secondary|Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligrams per decilitre (mg/dL) and C4 <16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percent Change||Full Range|Median
1221677|NCT00724867|Secondary|Observed Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligram per deciliter (mg/dL) and C4 <16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Milligrams per deciliter||Full Range|Median
1221678|NCT00724867|Secondary|Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.|Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage change||Full Range|Median
1221679|NCT00724867|Secondary|Observed Anti-double Stranded DNA Levels at Indicated Time Points.|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA >=30 International Units/milliliter [IU/mL]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||International units per milliliter||Full Range|Median
1221680|NCT00724867|Secondary|Percentage of Participants Achieving SRI Response at Indicated Time Points|The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MIIT Population|||Percentage of Participants|||Number
1221681|NCT00724867|Secondary|Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.|Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (<0.5 nanograms per milliliter [ng/mL]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 392|MITT Population|||Participants|||Number
1221682|NCT00724867|Primary|Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population. Only those subjects with abnormal (>124 umol/L) creatinine at baseline by year interval.|||Percentage of Participants|||Number
1221683|NCT00724867|Primary|Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Percentage of Participants|||Number
1221701|NCT00724854|Secondary|Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR|Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.|Treatment Week 48 and Treatment Week 72|Participants who achieved RVR at Treatment Week 4.|||Participants|||Number
1221685|NCT00724867|Primary|Number of Participants With the Indicated Immunogenic Response|Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Participants|||Number
1221686|NCT00724867|Primary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Units per liter||Standard Deviation|Mean
1221687|NCT00724867|Primary|Change From Baseline in BUN/Creatinine at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Ratio||Standard Deviation|Mean
1221688|NCT00724867|Primary|Change From Baseline in Creatinine Clearance at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Milliliters per second||Standard Deviation|Mean
1221689|NCT00724867|Primary|Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Micromoles per liter||Standard Deviation|Mean
1221690|NCT00724867|Primary|Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Millimoles per liter||Standard Deviation|Mean
1221691|NCT00724867|Primary|Change From Baseline in Albumin and Protein at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Grams per liter||Standard Deviation|Mean
1221702|NCT00724854|Secondary|Number of Participants With RVR Who Also Achieved SVR|RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.|Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)|Participants who achieved RVR at Treatment Week 4.|||Participants|||Number
1221703|NCT00724854|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.|Assessed at 24 weeks post-treatment||||Participants|||Number
1221693|NCT00724867|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Percentage||Standard Deviation|Mean
1221694|NCT00724867|Primary|Change From Baseline in Erythrocytes at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Trillions cells per liter||Standard Deviation|Mean
1221695|NCT00724867|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Billion cells per liter||Standard Deviation|Mean
1221696|NCT00724867|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Seconds||Standard Deviation|Mean
1221697|NCT00724867|Primary|SAE Rates by System Organ Class (SOC) During the Study|SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / participants Years. participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to Week 440|MITT Population|||Adverse events/100 participant-years|||Number
1221698|NCT00724867|Primary|AE Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / Participant Years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up Week 440|MITT Population|||Adverse events/100 participant-years|||Number
1221699|NCT00724867|Primary|Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)|An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.|Up to Week 440|Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.|||Participants|||Number
1221700|NCT00724854|Secondary|Assessment of Baseline Characteristics in Participants With SVR|Baseline characteristics assessed were age, gender, and genotype.|24 Weeks post-treatment|Participants with SVR|||Participants|||Number
1221704|NCT00724854|Primary|Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment|Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.|Assessed at Treatment Week 4||||Participants|||Number
1221709|NCT00724750|Secondary|Average Cost of Supplies and Rental|Direct costs for each type of dressing were measured. In the VAC group, this included rental charges for the equipment and the cost of supplies. In the G-SUC group, this included the cost of supplies (suction canisters, catheters or drains, tubing, gauze, and adhesive drapes).|Participants were followed for the duration of inpatient stay, an average of 5 days.||||dollars||Standard Deviation|Mean
1221710|NCT00724750|Secondary|Pain Score With Dressing Changes|Self-reported pain levels were used to assess pain. Patients were asked to rate their pain level according to the 0 to 10 linear analog scale immediately before, during, and after removal of the dressing. The average number of dressing changes for the G-SUC group was 4.5 (range 2-15) and the average number of dressing changes for the VAC group was 2.8 (range 2-6). The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels. The SPID score was calculated for each dressing change using the formula: (pain during - pain before) + (pain after - pain during). Higher values indicating greater pain.|Participants were followed for the duration of inpatient stay, an average of 5 days.||||units on a scale||95% Confidence Interval|Mean
1221711|NCT00724750|Secondary|Average Time Spent on Dressing Changes|Time was measured from the start of the dressing change until the initiation of suction.|Participants were followed for the duration of inpatient stay, an average of 5 days.||||minutes||Standard Deviation|Mean
1221712|NCT00724750|Secondary|Failure to Maintain Dressing Because of Fluid or Suction Leaks||Participants were followed for the duration of inpatient stay, an average of 5 days.||||participants|||Number
1221713|NCT00724750|Primary|Percent Change Per Day in Wound Volume|Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days||||% change per day||95% Confidence Interval|Mean
1221714|NCT00724750|Primary|Percent Change Per Day in Wound Surface Area|Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days||||% change per day||95% Confidence Interval|Mean
1221715|NCT00724711|Secondary|Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Participants Enrolled after Amendment 3~Missing = Excluded"|||pg/mL||Standard Deviation|Mean
1221716|NCT00724711|Secondary|Change From Baseline Fibrinogen at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded"|||mg/dL||Standard Deviation|Mean
1221717|NCT00724711|Secondary|Change From Baseline C-Reactive Protein at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded"|||mg/dL||Standard Deviation|Mean
1221718|NCT00724711|Secondary|Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||Ratio||Standard Deviation|Mean
1221719|NCT00724711|Secondary|Change From Baseline Fasting Lipid Parameters at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mg/dL||Standard Deviation|Mean
1221720|NCT00724711|Secondary|Change From Baseline Fasting Glucose at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mg/dL||Standard Deviation|Mean
1221721|NCT00724711|Secondary|Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mL/min/1.73m^2||Standard Deviation|Mean
1221722|NCT00724711|Secondary|Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set: The treated analysis set included all randomized participants who received at least one dose of study drug. Participants who were randomized to continue ABC/3TC+PI/r during the study were included in the treated analysis set if they took at least one dose of their study drug after the baseline visit.|||mL/min||Standard Deviation|Mean
1221723|NCT00724711|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"ITT Analysis Set~Missing = Excluded: Participants with missing values were excluded from this analysis"|||cells/microliter||Standard Deviation|Mean
1221724|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set~TLOVR: No virologic rebound on or before Week 48; no discontinuation before Week 48; no new ARV by study completion~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 50 copies/mL~Virologic Success: Last available HIV-1 RNA < 50 copies/mL in Week 48 window on randomized treatment"|||percentage of participants|||Number
1221725|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 200 copies/mL~Virologic Success: Last available HIV-1 RNA < 200 copies/mL in the Week 48 window while on randomized treatment"|||percentage of participants|||Number
1221726|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set|||percentage of participants|||Number
1221727|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set|||percentage of participants|||Number
1245533|NCT00541866|Secondary|All Cause Mortality|Mortality of those patients enrolled in the study and receiving intervention|30 and 60 days|All treated analysis set|||Participants|||Count of Participants
1221728|NCT00724711|Primary|Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm|The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|Intent-to-treat (ITT) Analysis Set: Participants who were treated with at least one dose of study drug with no documented resistance to study drug prior to screening.|||percentage of participants|||Number
1221729|NCT00724698|Primary|Adverse Events|Number of adverse events reported|Final Visit (Day 15)||||adverse events reported|||Number
1221730|NCT00724594|Secondary|Cytokine Level IL-1Ra in Plasma|anti-inflammatory cytokine Interleukin -1 Receptor alpha (IL-1Ra)|after N-acetylcysteine infusion||||IL-1Ra pg/ml||Inter-Quartile Range|Median
1221731|NCT00724594|Secondary|Magnetic Resonance Spectroscopy of Infants||36 - 40 weeks gestational age||||ratio of myoInositol/NAA in basal gangli||Standard Deviation|Mean
1221732|NCT00724594|Primary|Prothrombin Time|prothrombin clotting time|after N-acetylcystiene or saline infusion||||seconds||Standard Deviation|Mean
1221733|NCT00724594|Primary|Cerebral Blood Flow|Resistive index in middle cerebral artery (MCA)|after NAC infusion|blood flow resistive indices after first dose of N-acetylcysteine or saline|||ratio||95% Confidence Interval|Mean
1221734|NCT00724594|Primary|Maternal and Infant Mean Blood Pressure Change||Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing|The infant and maternal populations analyzed for this portion are incomplete, as not all individuals had paired before/after blood pressure measurements at this time point.|||mmHg||Standard Deviation|Mean
1221735|NCT00724594|Primary|Placental Transfer Ratio|Ratio of NAC concentration in cord to maternal venous blood|At time of delivery||||ratio||Standard Deviation|Mean
1221736|NCT00724594|Primary|NAC Concentrations||Peak: 30 minutes after NAC infusion. Cord: at delivery||||micromol/L||Standard Deviation|Mean
1221737|NCT00724594|Primary|NAC Total Body Clearance||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||mL/h/kg||Standard Deviation|Mean
1221738|NCT00724594|Primary|NAC Volume of Distribution||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||L/kg||Standard Deviation|Mean
1221739|NCT00724594|Primary|NAC Terminal Elimination Half-life||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||hours||Standard Deviation|Mean
1221740|NCT00724568|Secondary|The Percentage of Patients That Achieved Partial or Complete Response to Treatment.|"Partial Response:~50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.~If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to <200 mg for at least two determinations six weeks apart.~50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks.~No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).~Complete Response:~Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks.~<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks.~No increase in the size or number of lytic bone lesions."|24 weeks (8, 21-day cycles)|74 patients were enrolled, but 2 were not evaluable for dose limiting toxicities. 72 patients were included in this analysis.|||percentage of patients|||Number
1221741|NCT00724568|Primary|Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)|"Dose Level 1:~15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 2:~20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 3:~25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 4:~25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 30 mg/m2 Doxil daily on day 4"|1 month post treatment|A total of 74 patients were enrolled in this phase 1/2 study: 42 in phase 1.|||mg|||Number
1221742|NCT00724477|Primary|Number of Participants Reaching the Targeted LDL-C Levels|"A subject was considered to have met targeted LDL-C levels (been controlled) if:~subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L,~subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L,~subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L,~subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L,~subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L."|1 to 3 months after starting treatment|This was the efficacy population per protocol (PP) targeted for study treatment, and consisted of patients having taken INEGY at least once, with a primary efficacy criterion available (presence of risk factors or not plus lipid assessment after introduction of INEGY), and showing no major deviations from the protocol.|||Participants|||Number
1221743|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule|SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment.|24 weeks following completion of 24 or 48 weeks of therapy|No data had been captured in the Case Report Forms, and therefore no relevant analysis had been performed.||||||
1221744|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 250 participants.|||Participants|||Number
1221745|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis.|||Participants|||Number
1221746|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 6 participants.|||Participants|||Number
1221747|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 32 participants.|||Participants|||Number
1221748|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 157 participants.|||Participants|||Number
1221749|NCT00724464|Primary|Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up|Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.|||Participants|||Number
1221750|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. 23 participants were relapsers.|||Participants|||Number
1221751|NCT00724464|Primary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.|||Participants|||Number
1221752|NCT00724451|Secondary|Number of Participants With Treatment Failure by Reason for Failure|Investigators recorded reasons for treatment failure whether or not treatment was completed.|24 to 48 weeks|132 of the 500 treated participants failed treatment per Investigator assessment.|||participants|||Number
1221753|NCT00724451|Secondary|Number of Participants Discontinued From Treatment by Reason for Discontinuation|Investigators recorded reasons for treatment discontinuation.|24 weeks after the end of treatment (total of 48 to 72 weeks)|Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants.|||participants|||Number
1221754|NCT00724451|Primary|Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility|Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.|Measured at baseline|431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision.|||participants|||Number
1221755|NCT00724373|Primary|Participants With Treatment Success|Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).|Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.|Number of participants who had treatment success.|||Participants|||Number
1221756|NCT00724347|Primary|.Speech Discrimination Ability|Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.|Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..|older hearing impaired listeners with hearing aids.|||signal to noise ratio in dB SNR||Standard Deviation|Mean
1221757|NCT00724308|Secondary|VA Site-level Performance Rates on the VA Tobacco Performance Measures||Quarterly after study implementation|||||||
1221758|NCT00724308|Secondary|Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)||2 and 6 months after enrollment|||||||
1221759|NCT00724308|Secondary|Quit Attempt Rate||2 and 6 months after enrollment|||||||
1221760|NCT00724308|Secondary|30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)||2 months after enrollment|||||||
1221761|NCT00724308|Primary|Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)||6 months after enrollment||||participants|||Number
1221762|NCT00724282|Primary|Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test||at the end of each treatment|Investigator left university without analyzing data and no information is available on unblinding.||||||
1221763|NCT00724243|Primary|Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria|Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 14 and Week 54||||Participants|||Number
1221764|NCT00724243|Primary|Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|Baseline, Week 14, and Week 54|"Thirty-three participants had a DAS 28 score at the beginning of treatment.~Twenty-eight participants had a DAS 28 score at Week 14.~Twenty-two participants had a DAS 28 score at Week 54."|||Units on a Scale||Standard Deviation|Mean
1221765|NCT00724152|Secondary|Tinnitus Reaction Questionnaire (TRQ)|This is another commonly used measure of tinnitus distress in research. The TRQ is a global measure of tinnitus distress and was developed using correlations with clinician and self-report ratings of symptom categories. Scores on this measure range from 0 to 104 with higher scores indicating more distress. This measure has a high internal consistency reliability (Cronbach’s alpha = .96) and test-retest validity for the total score (r = .88). Scores of 17 points or higher on this measure will indicate tinnitus severity is such that the patient is significantly disturbed by tinnitus. This is based on the use of the TRQ as a pre-test measure in measuring outcome of a controlled trial of CBT for tinnitus in an elderly sample. That study sample had an average TRQ score of 16.9 prior to treatment.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)|Period 1 and Period 2|||units on a scale ranging 0-104||Standard Deviation|Mean
1221766|NCT00724152|Primary|Tinnitus Handicap Inventory (THI)|Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients’ responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus. The authors of the THI have designated levels of severity, with scores of 16 and below falling into the “no handicap” range. This measure has strong internal consistency reliability (Cronbach’s alpha = .93) and test-retest validity for the total score (r = .92). Significant improvement in tinnitus handicap can be observed with a 20-point change in total score.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)|Period 1 and Period 2|||units on a scale of 0-100||Standard Deviation|Mean
1221833|NCT00723580|Secondary|The Personality Inventory for Children: Achievement Scale|The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
1221767|NCT00724126|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.~Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.|||percentage of responders|||Number
1221768|NCT00724126|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.~Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.|||percentage of responders|||Number
1221769|NCT00724061|Other Pre-specified|Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells||Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase|||||||
1221770|NCT00724061|Other Pre-specified|Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment|The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients.|At baseline and after 2 weeks of treatment (for those patients who consented to this portion)|||||||
1221771|NCT00724061|Secondary|To Evaluate the Duration of Response|To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.|At each study visit|No data collected for this outcome measure.||||||
1221772|NCT00724061|Secondary|Number of Patients Exhibiting a Complete Response|"Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease.~CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR."|During 12 weeks of dose escalation and then up to one year during maintenance therapy.|No data collected for this outcome measure.||||||
1221773|NCT00724061|Primary|Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy – Biologic Response Modifier (FACT-BRM)|The FACT-BRM is a patient self-report tool to assess health-related quality of life measures.|During 12 weeks of dose escalation and then up to one year during maintenance therapy.|No data collected for this outcome measure.||||||
1221774|NCT00724061|Primary|Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b|"Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity."|From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)||||dose limiting toxicities|||Number
1221775|NCT00724009|Secondary|Leukemia Free Survival|Time to event analysis used the day of transplant as day 0.|2 years|One patient with refractory AML underwent conditioning but died 1 day before stem cell infusion due to sepsis (grade 5 infection)|||days||95% Confidence Interval|Median
1221776|NCT00724009|Secondary|Number of Participants Infection Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1221777|NCT00724009|Secondary|Number of Participants With Skin Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1221778|NCT00724009|Secondary|Number of Participants With Cardiac Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1221779|NCT00724009|Secondary|Number of Participants With Hepatic (SGOT) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1221780|NCT00724009|Secondary|Number of Participants With Hepatic (Total Bilirubin) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1221781|NCT00724009|Secondary|Number of Participants With Renal Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1221782|NCT00724009|Primary|Cytoreductive Response|Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%|Day 12||||percentage of participants|||Number
1221867|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 2)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
1221783|NCT00723957|Secondary|Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors|Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.|Randomization to death or last known alive date, up to 31.34 months|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
1221784|NCT00723957|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results|ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Aspartate aminotransferase (AST) Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN|At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)|All participants who received any investigational product.|||Participants|||Number
1221785|NCT00723957|Secondary|Number of Participants With Hematology Laboratory Results of Grade 3 or 4|LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: <LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3: <2.0 to 1.0*10^9/L, Grade 4: <1.0*10^9/L; Neutrophils (neutropenia) Grade 1: <LLN to 1.5*10^9/L, Grade 2: <1.5 to 1.0*10^9/L, Grade 3: <1.0 to 0.5*10^9/L, Grade 4: <0.5*10^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0*10^9/L, Grade 2: <75.0 to 50.0*10^9/L, Grade 3: <50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L; Hemoglobin (anemia) Grade 1: <LLN to 10.0 g/dL, Grade 2: <10.0 to 8.0 g/dL, Grade 3: <8.0 to 6.5 g/dL, Grade 4: <6.5 g/dL.|At screening and weekly during 21-day cycle|All participants who received any investigational product.|||Participants|||Number
1221786|NCT00723957|Secondary|Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21, continuously|All participants who received any investigational product.|||Participants|||Number
1221787|NCT00723957|Secondary|Time to Response|Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR])|Randomization to date of first response (PR or CR)|All randomized participants|||Weeks||Full Range|Median
1221788|NCT00723957|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)|Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles||||Percentage of participants||95% Confidence Interval|Mean
1221789|NCT00723957|Secondary|Progression-free Survival in the Overall Population|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death, assessed to 12.29 months|All randomized participants who received study drug|||Months||95% Confidence Interval|Median
1221790|NCT00723957|Secondary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death (maximum reached: 12.29 months)|All randomized participants who had βIII-tubulin positive tumors and who received study drug|||Months||95% Confidence Interval|Median
1221791|NCT00723957|Primary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.|Randomization to disease progression or death (maximum reached: 14.39 months )|All randomized participants with βIII-tubulin positive tumors and who received study drug|||Months||95% Confidence Interval|Median
1221792|NCT00723944|Secondary|Osseous Integration||4 years|||||||
1221793|NCT00723944|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage.|||millimeters|implants|Standard Error|Mean
1221794|NCT00723931|Primary|Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold|Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection.||||Participants|||Number
1221868|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 3)|Heart rate was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
1221795|NCT00723931|Primary|Number of Participants That Reported a Serious Adverse Event|Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection||||Participants|||Number
1221796|NCT00723892|Secondary|the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol||12 months after onset of treatment|Participants with no missing results.|||Weeks||Standard Deviation|Mean
1221797|NCT00723892|Primary|Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.||12 months after onset of treatment|Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.|||Participants|||Number
1221798|NCT00723840|Primary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease|"EQ-5D was calculated for the pharmacoeconomics analysis to evaluate quality of life (QoL) in participants in the active phase with Crohn's Disease and had a CDAI score >= 150.~EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.|||Score on a scale|||Number
1221799|NCT00723840|Primary|Cost of Illness in Participants With Crohn's Disease|"Direct health care costs, non health care costs and costs for productivity loss were calculated by observation period in Crohn's Disease participants (in active phase) with a CDAI score >= 150.~Direct health care costs refer to the resources used to prevent and treat a disease. Indirect costs include expenses for a participant's (or their caregiver's) transport, home assistance or home nursing assistance. Costs for productivity loss include the participant's (or their caregiver's) productivity loss or time loss."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.|||Euros|||Number
1221800|NCT00723827|Primary|Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)|The response ratings were based on the judgment of the investigator.|Complete study duration (up to approximately 6.5 months)||||participants|||Number
1221801|NCT00723827|Primary|Number of Temozolomide Drug Interactions|Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||events|||Number
1221802|NCT00723827|Primary|Number of Temozolomide Misuse or Abuse Events|"Drug abuse was defined as the use of the study drug for a non-therapeutic effect.~Misuse was defined as use of the study medication in a way that was not prescribed."|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||Events|||Number
1221803|NCT00723827|Primary|Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)|An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||participants|||Number
1221804|NCT00723827|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||participants|||Number
1221805|NCT00723801|Secondary|Diastolic Function - Ejection Fraction|Two-dimensional echocardiography was performed using a 3.0 MHz transducer (General Electric VIVID 7). Left ventricular and left atrial dimensions were determined in parasternal long axis views. Left ventricular ejection fraction was calculated using the modified Simpsons calculation in the apical two and four chamber views.|Baseline and 6 months||||Change in % ejection fraction||Standard Deviation|Mean
1221806|NCT00723801|Primary|Aortic Biophysical Properties - Pulse Wave Velocity|Aortic stiffness was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, West Ryde, NSW, Sydney, Australia) to measure carotid to femoral artery pulse wave velocity (PWV). With the patient lying supine in a quiet environment, a handheld micromanometer-tipped probe was applied to the skin surface over the carotid and femoral arteries, compressing the vessel wall so that transmural forces within the vessel wall were perpendicular to the arterial surface. The distance from the sternal notch to the sites of carotid and femoral pulse acquisition were measured and inputted into the device to represent the relative distance from the carotid to femoral artery. The calculation of distance divided by time of pulse upstroke relative to the upstroke of the QRS on a 3 lead surface EKG was used by the device to calculate velocity. All recorded measurements met the manufacturer’s quality control standards integrated into the software package.|Baseline and 6 months||||change in meters/second||Standard Deviation|Mean
1221807|NCT00723788|Primary|Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up|Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)|during diagnostic procedure|All patients received MRI, of those 20 also received US and 9 CT, meaning that 8 patients received all three procedures.|||participants|||Number
1221808|NCT00723749|Secondary|Drug Craving (Subjective Effects of Therapy)|Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)|Baseline and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||Units on a scale||Standard Deviation|Mean
1221869|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 2)|Heart rate was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
1221809|NCT00723749|Secondary|Take Home Prescriptions of SUBOXONE®|"Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.~Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.~A patient can receive only one take home prescription for up to 7 days at the time."|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||participants with take home prescription|||Number
1221810|NCT00723749|Primary|Retention Rate After 12 Months of Treatment With Suboxone|The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.|12 months|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||% of participants||95% Confidence Interval|Number
1221811|NCT00723749|Secondary|Dosage of SUBOXONE®|Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||mg daily dosage of Suboxone||Standard Deviation|Mean
1221812|NCT00723736|Primary|Proportion of Patients With Adverse Events|An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.|Follow-up visit at 3 - 5 weeks after treatment initiation||||participants|||Number
1221813|NCT00723710|Primary|Number of Participants Who Completed Treatment|Treatment completion was defined as those who completed both the induction and maintenance phases.|Up to 1 year|The number of participants who started the induction phase|||Participants|||Number
1221814|NCT00723697|Primary|Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.|Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|All eligible patients|||participants|||Number
1221815|NCT00723697|Secondary|Number of Patients Reporting Clinical Consequences of Engaging in Misuse|Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.|first visit, 6 months, and 12 months|Number of patients analyzed for the consequence, at each visit.|||participants|||Number
1221816|NCT00723697|Primary|Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)|Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|Number of patients with self-questionnaire responses.|||participants|||Number
1221817|NCT00723645|Secondary|Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)|"Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72.~SVR was defined as negative for HCV RNA at Week 24 of follow-up."|From 24 weeks post-treatment to 72 weeks post-treatment|"The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2).~187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3)."|||Percentage of participants||95% Confidence Interval|Number
1221818|NCT00723645|Primary|Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)|"Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT.~RNA= Ribonucleic Acid"|From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment|The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2).|||Percentage of participants||95% Confidence Interval|Number
1221819|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Prior Treatment Status|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
1221834|NCT00723580|Secondary|The Personality Inventory for Children: Adjustment Scale|This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment and developmentally associated change.|May-7-2008 to July -14-2010|||||||
1221820|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Ribavirin Dosage|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
1221821|NCT00723632|Primary|Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
1221822|NCT00723606|Secondary|Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours|BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
1221823|NCT00723606|Secondary|Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
1221824|NCT00723606|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
1221825|NCT00723606|Secondary|Change From Baseline in BPRS Agitation Subscale Score at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
1221826|NCT00723606|Secondary|BPRS Agitation Subscale Response at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score.|72 hours|FAS. Missing data were replaced by last observation carried forward (LOCF).|||participants|||Number
1221827|NCT00723606|Primary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours|BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.|Baseline, 72 hours|Per protocol (PP) population = Full Analysis Set (FAS) subjects (ie, randomized subjects who took at least one dose of study medication) who provided a baseline and 72 hour BPRS total score and did not deviate from the protocol in a significant manner.|||scores on a scale||Standard Error|Least Squares Mean
1221828|NCT00723580|Secondary|The Personality Inventory for Children: Family Relations Scale|The factors that underlie this scale are family stability, inter-parent communication, presence of love and happiness in the home and appropriateness of discipline. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
1221829|NCT00723580|Secondary|The Personality Inventory for Children: Social Skills Scale|The factors that underlie this scale are social success, social rejection, adults as only social contacts, and the ability to lead and follow. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
1221830|NCT00723580|Secondary|The Personality Inventory for Children: Withdrawal Scale|The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function|May-7-2008 to July -14-2010|||||||
1221831|NCT00723580|Secondary|The Personality Inventory for Children: Delinquency Scale|The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May 7, 2008-July 14,2010|||||||
1221832|NCT00723580|Secondary|The Personality Inventory for Children: Somatic-Physiological Scale|The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
1221835|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Hyperactivity Observed||May-7-2008 to July -14-2010|||||||
1221838|NCT00723580|Secondary|Systematic Observation Scale Item: Percentage of Impulsivity Observed|The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation.|May-7-2008 to July -14-2010|||||||
1221839|NCT00723580|Primary|Actigraphic Measurement of Treatment Conditions|The child’s impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions.|May 12- July 14, 2010|Single subject repeated Actigraphic(at thirty second intervals), observational (every two months) and psychometric (baseline and at 23 months) measurements of a child anticipating pharmacological treatment. Actigraphic measurements (three 21 day periods) over five treatment conditions that included a non-medication baseline and spanned 23 months.|||activity|Participants|Standard Deviation|Mean
1221840|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221841|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221842|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221843|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221844|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the end of study (EOS) visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221870|NCT00723554|Primary|Heart Rate - Iloprost PD-6 (Period 1)|Heart rate was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population|||beats per minute||Standard Deviation|Mean
1221845|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221846|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221847|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221848|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221849|NCT00723554|Secondary|New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1221850|NCT00723554|Secondary|Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
1221851|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
1221852|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
1221853|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
1221854|NCT00723554|Secondary|Change in Average Number of Daily Doses - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
1221855|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
1221856|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
1221857|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
1221858|NCT00723554|Secondary|Change in Average Number of Days of Dosing - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
1221859|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
1221860|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
1221861|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
1221862|NCT00723554|Secondary|Change in Average Inhalation Time - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
1221863|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
1221864|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
1221865|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
1221866|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 3)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
1221871|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 3)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1221872|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 2)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1221873|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 3)|Diastolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1221874|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 2)|Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1221875|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-6 (Period 1)|Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1||||mmHg||Standard Deviation|Mean
1221876|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 3)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1221877|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 2)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1221878|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 3)|Systolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1221879|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 2)|Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1221880|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-6 (Period 1)|Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population|||mmHg||Standard Deviation|Mean
1221881|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Serious AEs|Number of patients reporting at least one treatment-emergent serious AEs|From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population|||participants|||Number
1221882|NCT00723554|Primary|Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE|Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment|From the first dose of investigational product to study discontinuation, an average of approximately 268 days|Safety population|||participants|||Number
1221883|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Adverse Events (AEs)|Number of patients reporting at least one treatment-emergent AE/Serious AE|From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population|||participants|||Number
1221884|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.|||Percentage of participants|||Number
1221885|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.|||Percentage of participants|||Number
1221886|NCT00723528|Secondary|Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64|Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1221887|NCT00723528|Secondary|Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64|The number of nails with psoriasis involvement was assessed by a dermatologist.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Nails||Standard Deviation|Mean
1221888|NCT00723528|Secondary|Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 12, 28, 40,52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1221889|NCT00723528|Secondary|Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64|The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1221890|NCT00723528|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1221891|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1221892|NCT00723528|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.|||Percentage of participants|||Number
1221893|NCT00723528|Secondary|Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.|||Percentage of treatment response||Standard Deviation|Mean
1221894|NCT00723528|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.|||Units on a scale||Standard Deviation|Mean
1221895|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 12|"The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on scale||Standard Deviation|Mean
1221896|NCT00723528|Primary|Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score|Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.|||Percentage of participants|||Number
1221897|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D TC – (AD) Compared to YFV-17D TC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
1221898|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D SC –(AD) Compared to YFV-17D SC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
1221899|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive , CD4 Positive T-cells, YFV-17D TC – (AD) Compared to YFV-17D TC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD4 Positive T-cells that express IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T- Cells (Day 30). A higher count reflects a better immune response to Yellow Fever virus.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
1221900|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD4 Positive T-cells, YFV-17D SC – (AD) Compared to YFV-17D SC – (Non- AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD4 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T-cells on Day 30 (acceptable blood draw window: Day 28 – 35).|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(Non-AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
1221901|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters|||participants|||Number
1221902|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D TC– (AD) Participants Compared to YFV-17D TC – (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters|||participants|||Number
1221903|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||Log10 (NT50)||Standard Deviation|Mean
1221904|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D TC – (AD) Participants Compared to YFV-17D TC – (Non – AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||Log10 (NT50)||Standard Deviation|Mean
1221905|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D SC – (AD) Participants Compared to YFV-17D SC– (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization)|All participants who completed the study; and seroconverted|||Log10 Neutralization Index (LNI)||Standard Deviation|Mean
1221906|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC– (AD) Participants Compared to YFV-17D TC– (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||LNI||Standard Deviation|Mean
1221926|NCT00723450|Secondary|Time From Randomization to Intervention for a Mood Episode (TIME)|The time from randomization to the intervention for a mood episode (depression, mania/hypomania or mixed mood) was analyzed. TIME was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for a mood episode (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
1221907|NCT00723450|Secondary|Change From Randomization in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Randomized Phase.|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221908|NCT00723450|Secondary|Change From Baseline in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Open-Label Phase|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221909|NCT00723450|Secondary|Change From Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Randomized Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221910|NCT00723450|Secondary|Change From Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Open-Label Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221911|NCT00723450|Secondary|Change From Randomization in the Young Mania Rating Scale (YMRS) at Each Visit in the Randomized Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221912|NCT00723450|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) at Each Visit in the Open-Label Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221913|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Randomization in the Randomized Phase|The CGI-BP(I) asks the following question: “Compared to the Randomization assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Participants|||Number
1221914|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Baseline in the Open-Label Phase|The CGI-BP(I) asks the following question: “Compared to the Baseline assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.|||Participants|||Number
1221915|NCT00723450|Secondary|Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Randomized Phase|Improvement of bipolar illness was based on the CGI-BP(I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Randomization weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32 and 36|Randomized ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Randomized ITT Population.|||Scores on a scale||Standard Deviation|Mean
1221916|NCT00723450|Secondary|Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Open-label Phase|Improvement of bipolar illness was based on the CGI-BP (I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.|||Scores on a scale||Standard Deviation|Mean
1221917|NCT00723450|Secondary|Change From Randomization in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Randomized Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221918|NCT00723450|Secondary|Change From Baseline in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Open-Label Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221919|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221920|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Open-Label Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221921|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Randomized Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1221922|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Open-Label Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT population: all participants who entered the Open-Label Phase and received at least one dose of LTG.|||Scores on a Scale||Standard Error|Least Squares Mean
1221923|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase|The proportion of participants (par.) requiring intervention to treat either the emergence of or a change in bipolar symptoms, that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state at any time within the first 30, 90, and 180 days in the Randomized Phase were analyzed.|From randomization up to Week 36|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.|||Participants|||Number
1221924|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State|The number of participants requiring intervention to treat either the emergence of or a change in bipolar symptoms that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state were analyzed.|From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36)|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.|||Participants|||Number
1221925|NCT00723450|Secondary|Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix)|The time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix) was analyzed. TIDep, TIMan, and TIMix were calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
1222022|NCT00722436|Secondary|Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).||(baseline, after osteotomies, and immediately after procedure)||||seconds||Standard Deviation|Mean
1221927|NCT00723450|Secondary|Time From Randomization to Withdrawal From the Study for Any Cause (TTW)|The time from randomization to the withdrawal from study was analyzed. TTW was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until withdrawal from the study for any cause (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
1221928|NCT00723450|Primary|Time From Randomization to the Occurrence of a Bipolar Event (TOBE)|TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until Week 36|Randomized Intent-to-Treat (ITT) Population: all participants who were randomized to LTG or placebo and received at least one dose of investigational product.|||Days||Standard Error|Mean
1221929|NCT00723398|Secondary|Changes in Complete Blood Count: White Blood Cells and Platelets|Changes in complete blood count levels as measured through white blood cells (WBC) and platelets. Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||thousand cells/mL||Standard Deviation|Mean
1221930|NCT00723398|Secondary|Changes in Complete Blood Count: Hematocrit|Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||volume percentage||Standard Deviation|Mean
1221931|NCT00723398|Secondary|Changes in Complete Blood Count: Hemoglobin|Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||g/dL||Standard Deviation|Mean
1221932|NCT00723398|Secondary|Changes in Complete Blood Count: Red Blood Cells|Changes in complete blood count levels as measured through red blood cells (RBC). Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||millions of cells per microliter||Standard Deviation|Mean
1221933|NCT00723398|Secondary|Changes in Serum Lipid Levels|Changes in serum lipid levels as measured through total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||mg/dL||Standard Deviation|Mean
1221934|NCT00723398|Secondary|Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)|Changes in insulin-like growth factor-1 (IGF-1) and insulin-like growth factor-1 binding protein-3 (IGFBP-3) obtained through blood sample. Specific time points for evaluation are baseline and Year +1 (only).|1 year|Measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 46).|||ng/mL||Standard Deviation|Mean
1221935|NCT00723398|Secondary|Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)|Changes in serum biomarkers for inflammation including highly sensitive C-reactive protein and IL-6 obtained through a blood draw. Specific time points for evaluation are baseline and Year +1 (only).|1 Year|Biomarker measurements were not taken for the entire population of the study (N = 266) due to non-significant trends for treatment effects found in this initial population (n = 89).|||pg/ml||Standard Deviation|Mean
1221936|NCT00723398|Secondary|Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)|Changes in biomarkers for estrogen metabolism: 2-hydroxy estrone (Urinary 2-OHE1) and 16-α-hydroxy estrone (16α-OHE1) as measured by urinary analysis. Specific time points for evaluation are baseline and Year +1 (only).|1 year|Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).|||ng/mg creatinine||Standard Deviation|Mean
1221937|NCT00723398|Secondary|Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine|Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-hydroxy-deoxyguansine as measured through urinary analysis.|1 year|Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).|||ng/mg creatinine||Standard Error|Mean
1221938|NCT00723398|Secondary|Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α|Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-(isoprostane) F-2α as measured through urine analysis.|1 year|Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).|||pg/mg creatinine||Standard Error|Mean
1221939|NCT00723398|Primary|Change in Absolute Breast Density|Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||cm squared||Standard Deviation|Mean
1221940|NCT00723294|Secondary|Pain Assessment||Up to 14 days post surgery||2017-12-31|12/2017||||
1221941|NCT00723294|Secondary|Adverse Events||Up to 14 days post surgery||2017-12-31|12/2017||||
1222023|NCT00722436|Primary|Number of Patients That Remained Transfusion Free||24 hours||||participants|||Number
1221942|NCT00723294|Secondary|Negative Predictive Value of MRI|Negative predictive value of MRI: The negative predictive rate of MRI will be estimated as the number of patients with no residual disease upon pathologic review of the resected tissue AND with a MRI that indicated no residual disease divided by the number of patients who had an MRI that indicated no residual disease. Both a binomial point estimate and 90% two-sided confidence interval will be computed.|Up to 14 days post cryoablation|One patient had bilateral disease and therefore outcomes are reported for 87 cancers.|||percentage of cancers|cancers|90% Confidence Interval|Number
1221943|NCT00723294|Primary|Rate of Complete Tumor Ablation|The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound).|Up to 14 days post surgery|One patient had bilateral disease and therefore outcomes are reported for 87 lesions.|||percentage of lesions|lesions|90% Confidence Interval|Number
1221944|NCT00723255|Secondary|Progression-free Survival at 6 Months by Tumor Grade|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
1221945|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
1221946|NCT00723255|Secondary|Progression-free Survival at 6 Months by Histologic Type|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
1221947|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
1221948|NCT00723255|Secondary|Progression-free Survival at 6 Months by Performance Status|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
1221949|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Performance Status|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
1221950|NCT00723255|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, up to 5 years|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
1221951|NCT00723255|Secondary|Progression-Free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
1221952|NCT00723255|Primary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Every cycle and 30 days after the last treatment, an average of 5 years.|Eligible and evaluable patients|||Participants|||Count of Participants
1221953|NCT00723255|Primary|Progression-free Survival at 6 Months|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1221954|NCT00723255|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1221955|NCT00723229|Secondary|Duration of Genital HSV Shedding Episodes|Median duration of HSV shedding episodes, in hours|9 weeks|Only episodes of known duration were included|||Hours|Episodes|Inter-Quartile Range|Median
1221956|NCT00723229|Secondary|Number of Genital HSV Shedding Episodes|The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs|9 weeks|The number of participants analyzed is the same as the overall number. No participants were excluded from this analysis.|||Episodes|||Number
1221957|NCT00723229|Secondary|Quantity of HSV Detected, Median|Median quantity of HSV detected, among swabs with any HSV detected|9 weeks|The number of swabs with HSV detected was analyzed. This is a subset of overall numbers of swabs collected, since not all swabs had HSV detected.|||log 10 copies/ml|Swabs|Inter-Quartile Range|Median
1221958|NCT00723229|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.||9 weeks|Participants collected at least one swab on each study arm|||percentage of swabs with HSV detected|Swabs||Number
1245555|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population||Week 13|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1221959|NCT00723203|Primary|Hematological Response Rate|Morphologic CR: morphologic leukemia-free state with absolute neutrophil count > 1000/uL and platelet count ≥ 100,000/uL and independent of blood transfusions. Cytogenic CR: morphologic CR along with reversion to a normal karyotype by cytogenetic analysis. Molecular CR: morphologic CR with no residual disease by molecular or flow cytometric detection methods. Morphologic CR with incomplete blood recovery (CRi): morphologic CR except for residual neutropenia (<1000/uL) and/or thrombocytopenia (<1000,000/uL). PR: same hematologic values for a CR but with a decrease of at least 50% in percentage of blasts to a post-treatment value of 5% to 25% in bone marrow aspirate. (If the pre-treatment blast percentage was 50-100% this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49% this must decrease by at least half to a value > 5%.) A value ≤ 5% is also considered a PR if Auer rods are present. Hematological response = morphologic CR+PR.|Up to 6 cycles of treatment, up to 24 weeks.|Three patients of the 16 accrued were not included in the analysis for response per protocol due to patient refusal for alternative treatment prior to completing the first cycle of treatment.|||percentage of responding participants|||Number
1221960|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-I scale:~1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1221961|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-S scale:~1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1221962|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4||At baseline and at Week 4|Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||beats per minute||Standard Deviation|Mean
1221963|NCT00723190|Primary|Change From Baseline in Heart Rate at Week 4|Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||beats per minute||Standard Deviation|Mean
1221964|NCT00723190|Primary|Change From Baseline in Body Temperature at Week 4|Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Fahrenheit||Standard Deviation|Mean
1221965|NCT00723190|Primary|Change From Baseline in Systolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||mmHg||Standard Deviation|Mean
1221966|NCT00723190|Primary|Change From Baseline in Diastolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||mmHg||Standard Deviation|Mean
1221967|NCT00723190|Primary|Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12||At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Kilograms||Standard Deviation|Mean
1221968|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett’s (QTcB) at Week 4||At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||milliseconds||Standard Deviation|Mean
1221969|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Events|||Number
1221970|NCT00723190|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12|The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1221992|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L/Sec||Standard Deviation|Mean
1221971|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Participants|||Number
1221972|NCT00723177|Secondary|The Effects of AV411 on the Analgesic Effects of Oxycodone.|The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.|Measured at the end of each AV411 of the three two-week maintenance periods||||units on a scale||Standard Deviation|Mean
1221973|NCT00723177|Primary|Subjective Opioid Withdrawal Scale Score (SOWS)|Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.|Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).|Only 30 of the total number of 44 enrolled completed the study .|||units on a scale||Standard Error|Mean
1221974|NCT00723125|Secondary|Measure of Safety and Tolerability According to CTC Version 3.0||2 years|||||||
1221975|NCT00723125|Primary|Pathological Complete Response Rates at Surgery||at surgery approximately 5 months after initial treatment|Cohort1: 33 pts enrolled to cohort 1,33 underwent surgery even if they did not complete all treatment Cohort 2: 27 enrolled to cohort 2 and 27 underwent surgery, even if they did not complete all treatment|||participants|||Number
1221976|NCT00723073|Secondary|Duration of Neutropenia|Median number of days patients were neutropenic during the study period|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
1221977|NCT00723073|Secondary|Duration of Hospitization|Median number of days patients were hospitalized during the study period|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
1221978|NCT00723073|Secondary|Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation|The description of the adverse event that resulted in discontinuation of echinocandin (EC) therapy|11/1/2005 - 10/31/2007||||participants|||Number
1221979|NCT00723073|Secondary|Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy|aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5x the upper limit of normal (ULN) or total bilirubin > 3x the upper limit of normal (ULN)|11/1/2005 - 10/31/2007||||participants|||Number
1221980|NCT00723073|Secondary|Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN)|median duration of therapy with an echinocandin (caspofungin or micafungin) for persistent febrile neutropenia (FN)|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
1221981|NCT00723073|Primary|Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy|Defined as any advsere event directly attributable to echinocandin treatment that led to discontinuation of therapy or switch to alternative therapy|11/1/2005 - 10/31/2007||||participants|||Number
1221982|NCT00723073|Primary|Absence of Any Breakthrough Invasive Fungal Disease (IFD)|a breakthrough invasive fungal disesase was defined as any fungal infection that was diagnosed > 3 days on or during therapy or within 7 days after completion of therapy with an echinocandin|11/1/2005 - 10/31/2007||||participants|||Number
1221983|NCT00723073|Primary|Mortality at Hospital Discharge|We assessed all patients in the study cohort who dischaged from the hospital alive|11/1/2005 - 10/31/2007||||participants|||Number
1221984|NCT00723073|Primary|Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)|Possible or proven baseline invasive fungal disease were defined as were diagnosed within the 2 days of initiating echinocandin therapy for persistent febrile neutropenia|11/1/2005 - 10/31/2007||||participants|||Number
1221985|NCT00723073|Primary|Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)|Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.|11/1/2005 - 10/31/2007||||participants|||Number
1221986|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]|AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).|14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.||||||
1221987|NCT00723021|Other Pre-specified|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.||||||
1221988|NCT00723021|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.||||hrs||Full Range|Median
1221989|NCT00723021|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
1221990|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.|||ng*h/mL||Standard Deviation|Mean
1221991|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1221993|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline,24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1221994|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1221995|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1221996|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1221997|NCT00723008|Primary|Mean General Sleep Disturbance Scale (GSDS) Score|The GSDS is a questionnaire used to qualitatively evaluate sleep. This 21-question tool evaluates each aspect of sleep and restfulness on a 0-7 score, indicating the number of days per week that each problem may be present. Total scores range from 0-147, with higher scores indicating more profound disturbances in sleep.|Baseline, Week 4, Week 8|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Score||Standard Deviation|Mean
1221998|NCT00723008|Primary|Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their anxiety level before and after each daily CES treatment. Responses were scored on a scale ranging from 0 (indicating no anxiety) to 10 (worst possible).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval|||VAS-A Score||Standard Deviation|Mean
1221999|NCT00723008|Primary|Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their pain intensity before and after each daily CES or sham treatment. Responses were scored on a scale ranging from 0 (indicating no pain) to 10 (worst possible pain).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||VAS-P Score||Standard Deviation|Mean
1222000|NCT00723008|Primary|Mean Brief Profile of Mood States (BPOMS) Score|BPOMS is a tool used to qualitatively measure anxiety. Subjects were asked to evaluate 30 feelings that they may have had over the past week. Stress-associated feelings are scored on a 5-point Likert scale from 0 (not at all)to 4 (extremely). Six of the feelings listed on the questionnaire are not associated with anxiety and therefore are not scored. Total scores range from 0-96, with higher scores indicating greater tension and anxiety.|Baseline, Week 4, Week 8|One A:Active/Unblinded subject was removed from analysis due to a 39-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Brief POMS Score||Standard Deviation|Mean
1222001|NCT00723008|Primary|Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score|This 20-item questionnaire measures depressive symptoms. Scores can range from 0-60, with scores greater than 16 indicating need for further evaluation due to possible Major Depression.|Baseline, 4 Weeks, 8 Weeks|One A:Active/Unblinded subject was removed from analysis due to a 31-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Score||Standard Deviation|Mean
1222002|NCT00723008|Primary|Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score|Subjects were asked to complete questionnaire three times during the course of study. Questions addressed symptoms associated with Post Traumatic Stress Disorder(PTSD). Scores can range from 17 to 85. A score >31 was used to identify symptomatic subjects and was therefore required at baseline for study enrollment.|Baseline, Week 4, Week 8|All active subjects|||Score||Standard Deviation|Mean
1222003|NCT00722865|Secondary|Safety|Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)|2 years||||Participants|||Count of Participants
1222004|NCT00722865|Secondary|Overall Survival|Overall survival: patients are still alive.|2 years||||Participants|||Count of Participants
1222005|NCT00722865|Secondary|Progression-free Survival|Progression-free survival: a patient lives with the disease but it does not get worse.|2 years and medium follow-up of 18 months||||percentage of participants||90% Confidence Interval|Number
1222006|NCT00722865|Secondary|Overall Response Rate Using the Modified Cheson Criteria|Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT|2 years||||percentage of participants||90% Confidence Interval|Number
1222007|NCT00722865|Primary|Failure-free Survival|Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy|2 years and median follow-up of 18 months||||percentage of participants||90% Confidence Interval|Number
1222008|NCT00722800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|6 months||||points||Standard Deviation|Mean
1222020|NCT00722553|Primary|Objective Response Rate (ORR)|The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment.||||participants|||Number
1222009|NCT00722800|Secondary|Change From Baseline in VAS Pain Scale at Month 6.|"For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated no pain and a score of 10 indicated worst pain. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|6 months from Baseline||||units on a scale||Standard Deviation|Mean
1222010|NCT00722800|Primary|Mean Improvement in the Sartorius Severity Score at Month 6.|The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|6 months||||units on a scale||Standard Deviation|Mean
1222011|NCT00722761|Secondary|Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination|Percentage of subjects rated Clear (score 0) or Almost Clear (score 1) on the Investigator's Global Assessment (IGA) of truncal acne at Week 24 as well as Subject's Assessment of Acne at Week 24/Early Termination were taken. It was computed by: number of successes (those scored 0 or 1)divided by the number of participants multiplied by 100.|24 weeks|Intention to treat analysis. Participants with at least one follow up visit were included in the analysis. Last observation carried forward was used to fill up missing values/|||percentage of participants|||Number
1222012|NCT00722761|Primary|Percent Change in Truncal Lesion Counts|Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.|0-24 weeks|Intention to treat analysis. Only participants with at least one follow up were included in the analysis. Last observation carried forward was used to fill up missing data.|||percentage change of lesions||Standard Deviation|Mean
1222013|NCT00722722|Primary|Response to Bortezomib Monotherapy|Response to treatment with Bortezomib (BTZ) alone was defined as a reduction in serum Donor Specific Alloantibody (DSA) levels following treatment. DSA levels were measured prior to treatment and after treatment. A good response occurred if all DSA were reduced. A partial response when a reduction was observed in at least one DSA, but not all DSA. No response occurred when no reduction of any DSA was attained.|6 months|In the 32 dose group, one patient received a kidney transplant with a B-cell flow cytometric crossmatch channel shift of less than 300 after dose 20 and was transplanted with a positive crossmatch donor. This patient was then excluded from further DSA analysis.|||participants|||Number
1222014|NCT00722566|Secondary|Number of Patients With Complete Response|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.~Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks."|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.|||Participants|||Number
1222015|NCT00722566|Primary|Number of Patients With Overall Response (Complete Response + Partial Response)|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.~Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.~Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg"|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.|||Participants|||Number
1222016|NCT00722553|Secondary|Overall Survival (OS)|The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months.|Analysis per protocol. Patients who had not died or were lost to follow-up were censored|||Months||95% Confidence Interval|Median
1222017|NCT00722553|Secondary|Progression Free Survival (PFS)|Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography [CT] or magnetic resonance imaging [MRI] scan, whichever indicates PD) or death, regardless of cause.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored.|||Months||95% Confidence Interval|Median
1222018|NCT00722553|Secondary|Clinical Benefit Rate (CBR)|The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)|Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.||||participants|||Number
1222019|NCT00722553|Secondary|Duration of Response (DOR)|Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.|Measured from the first day of documented response for up to 2 years after enrollment.|Analysis was per protocol, based on the number of all responding patients both confirmed and unconfirmed (n=5) in the evaluable population (n=30)|||Days||95% Confidence Interval|Median
1222024|NCT00722436|Primary|Total Volume (ml/kg) of Allogeneic Blood Exposure.|This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.|intraoperative and postoperative (24 hr)||||ml/kg||Standard Deviation|Mean
1222025|NCT00722423|Secondary|Antiviral Treatment Rate|Number of patients started antiviral treatment|12-24 weeks post-treatment||||percentage of participants|||Number
1222026|NCT00722423|Primary|Sustained Virologic Response Rates|Virus not detected by PCR assay|12-24 weeks post-treatment||||participants|||Number
1222027|NCT00722371|Secondary|Change From Baseline in 2-Hour PMG at Week 54|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1222028|NCT00722371|Secondary|Change From Baseline in FPG at Week 54||Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1222029|NCT00722371|Primary|Change From Baseline in A1C at Week 54|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1222030|NCT00722371|Secondary|Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1222031|NCT00722371|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24||Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1222032|NCT00722371|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|Full Analysis Set with last observation carried forward (LOCF). Reasons for exclusion included no baseline data and/or no post-baseline data.|||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1222033|NCT00722137|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug.|Up to 107.4 months|The safety population was defined as all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1222034|NCT00722137|Secondary|Overall Survival (OS) in Long Term Follow-up Period|OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.|Up to 107.4 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1222035|NCT00722137|Secondary|18-Month Survival|18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).|Up to month 18 from the time of randomization|The population consisted of all randomized participants.|||Percentage of Participants||95% Confidence Interval|Mean
1222036|NCT00722137|Secondary|Overall Survival (OS)|OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1222037|NCT00722137|Secondary|Overall Complete Response (CR + CRu)|Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Participants|||Number
1222038|NCT00722137|Secondary|Overall Response Rate (ORR)|ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Participants|||Number
1222039|NCT00722137|Secondary|Treatment-free Interval (TFI)|The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive.|Median duration of follow-up of 40 months|All randomized participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1222040|NCT00722137|Secondary|Time to Next Anti-lymphoma Treatment (TTNT)|The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive.|: Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1222135|NCT00721578|Secondary|Medication Administration|Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration.|Up to 9 months|FAS.|||Participants|||Number
1222041|NCT00722137|Secondary|Duration of Response|The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had >= 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Days||95% Confidence Interval|Median
1222042|NCT00722137|Secondary|Time to Progression (TTP)|Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1222043|NCT00722137|Primary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1222044|NCT00722124|Primary|7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)|7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide <8ppm)|8 weeks|Analysis was performed using intention to treat(ITT). Subjects who discontinued study participation were assumed to be smoking.|||participants|||Number
1222045|NCT00722111|Primary|Maximum Isometric Tongue Pressure|Peak isometric pressure at 4 sensors|16 months|PI is not available, thus the numbers presented are what was initially entered by research team. For the other treatment arms, data is unavailable, as PI is not available.Data was only available for two arms. All efforts were made to retrieve data.|||kPa||Full Range|Mean
1222046|NCT00722111|Primary|Isometric Lingual Pressure|Tongue Strength|8 weeks|PI is not available, thus the numbers presented are what was initially entered by research team. For the other treatment arms, data is unavailable, as PI is not available. Data was only available for one arm. All efforts were made to retrieve data.|||kPa||Full Range|Mean
1222047|NCT00722072|Secondary|Overall Survival||28 to 56 days after discontinuation of study therapy|Long term survival data was not collected due to early study termination||||||
1222048|NCT00722072|Secondary|Progression-free Survival||Start of treatment to time of progression or death, whichever comes first.|Long term survival data was not collected due to early study termination||||||
1222049|NCT00722072|Secondary|Time to Progression||Start of treatment to time of progression.|Progression data was not collected due to early study termination.||||||
1222050|NCT00722072|Secondary|Objective Response Rate||Every 8 weeks (two cycles) while receiving study therapy.|Response assessment data was not collected past 4 months due to early study termination.||||||
1222051|NCT00722072|Primary|Number of Participants With Progression-free Survival at 4 Months|Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).|4 months after initiating treatment with sorafenib plus fulvestrant.||||Participants|||Number
1222052|NCT00722020|Secondary|Secondary Endpoint Total Hospital Length of Stay|Seconadary endpoint was Total Hospital length of stay|30 Days||||days||Standard Deviation|Mean
1222053|NCT00722020|Primary|The Primary Endpoint Will be Time to Readiness for Discharge.|Days in the hospital prior to patient being clinically ready to discharge|30 days|asthmatic children|||days||Standard Deviation|Mean
1222054|NCT00721968|Other Pre-specified|Number of Ocular Hypotensive Medications by Visit||12 months||||medications||Standard Deviation|Mean
1222055|NCT00721968|Primary|Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications|Percent reaching this endpoint|12 months|Number of subjects at Month 12 with IOP ≤ 18 mmHg without topical hypotensive medications|||participants|||Number
1222056|NCT00721955|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|Baseline and 2 hours|ITT Population with LOCF|||Participants|||Count of Participants
1222057|NCT00721955|Secondary|Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
1222058|NCT00721955|Primary|Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo|The Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
1222059|NCT00721799|Primary|Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change||Standard Deviation|Mean
1222136|NCT00721578|Secondary|Median Duration of Antifungal Therapy||Up to 9 months|FAS.|||Days||Full Range|Median
1222060|NCT00721799|Primary|Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-Patlak||Standard Deviation|Mean
1222061|NCT00721799|Primary|Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-FLT||Standard Deviation|Mean
1222062|NCT00721799|Primary|Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmax||Standard Deviation|Mean
1222063|NCT00721799|Primary|Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmean||Standard Deviation|Mean
1222064|NCT00721799|Primary|Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222065|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the mid-therapy FLT PET scan|||l/min||Standard Deviation|Mean
1222066|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat).Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the mid-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
1222067|NCT00721799|Primary|Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222068|NCT00721799|Primary|Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222069|NCT00721799|Primary|Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222070|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the pre-therapy FLT PET scan|||l/min||Standard Deviation|Mean
1222071|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
1222072|NCT00721799|Primary|Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS)|Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mm^3 (cubic milimeters)||Standard Deviation|Mean
1222073|NCT00721799|Primary|Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222074|NCT00721799|Primary|Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222075|NCT00721799|Primary|Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change||Standard Deviation|Mean
1222076|NCT00721799|Primary|Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-Patlak||Standard Deviation|Mean
1222077|NCT00721799|Primary|Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-FLT||Standard Deviation|Mean
1222078|NCT00721799|Primary|Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmax||Standard Deviation|Mean
1222079|NCT00721799|Primary|Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmean||Standard Deviation|Mean
1222080|NCT00721799|Primary|Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222081|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the mid-therapy FLT PET scan|||l/min||Standard Deviation|Mean
1222082|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the mid-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
1222083|NCT00721799|Primary|Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222137|NCT00721578|Secondary|Concomitant Medications||Up to 9 months|FAS.|||Participants|||Number
1222084|NCT00721799|Primary|Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222085|NCT00721799|Primary|Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222086|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the pre-therapy FLT PET scan|||l/min||Standard Deviation|Mean
1222087|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
1222088|NCT00721799|Primary|Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)|Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mm^3 (cubic milimeters)||Standard Deviation|Mean
1222089|NCT00721799|Primary|Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222090|NCT00721799|Primary|Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1222091|NCT00721734|Secondary|Time to Progression (TTP)|Time to Progression is defined as the time from first dose of carfilzomib to disease progression. Median TTP was estimated using Kaplan-Meier methods.|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population|||months||95% Confidence Interval|Median
1222092|NCT00721734|Secondary|Duration of Response|"Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death.~Progressive disease was defined as any of the following:~An increase of more than 25% from nadir in any one of the following:~M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL);~Urine (the absolute increase had to be ≥ 200 mg/24 hours);~The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be > 10 mg/dL);~≥ 10% bone marrow infiltration by plasma cells;~Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas.~Median duration of response was estimated using the Kaplan-Meier method."|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.|||months||95% Confidence Interval|Median
1222093|NCT00721734|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate is defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89% from baseline, maintained for at least 6 weeks.|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population|||percentage of participants||95% Confidence Interval|Number
1222111|NCT00721734|Primary|Clearance (CL) of Carfilzomib on Day 1 of Cycle 1|Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method.|Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|"The pharmacokinetic (PK) evaluable population includes participants with stable baseline renal function (Arms 1–4) who completed all protocol-specified treatment and PK blood sample collection through Cycle 1, Day 16. In Group 5, only samples collected before dialysis were included.~CL could not be estimated for 11 patients in the PK population."|||liters/hour||Standard Deviation|Mean
1222112|NCT00721630|Secondary|Number of Participants With Toxicities Associated With Capecitabine and Lapatinib|Toxicities evaluated according to NCI CTC v.3|6 months||||Participants|||Count of Participants
1222094|NCT00721734|Secondary|Overall Response Rate (ORR)|"ORR is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Uniform Response Criteria for Multiple Myeloma.~sCR: CR as defined below plus normal serum free light chain (sFLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or immunofluorescence; CR: absence of M-protein in serum and urine confirmed by immunofixation and < 5% plasma cells in the bone marrow; VGPR: serum and urine M-proteins detectable by immunofixation, but not by electrophoresis or a ≥ 90% reduction in serum M-protein from baseline, plus a urine M-protein level of < 100 mg/24 hours; PR: reduction of M-protein in serum of ≥ 50% and in urine of ≥ 90% from baseline. If serum and urine M-protein were not measureable at baseline, a ≥ 50% decrease in the difference between involved and uninvolved sFLC levels from baseline."|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population included all participants with measurable disease and a baseline and at least 1 post-baseline disease assessment or who discontinued study treatment due to a related adverse event prior to obtaining an on-study disease assessment.|||percentage of participants||95% Confidence Interval|Number
1222095|NCT00721734|Secondary|Plasma Protein Binding (PPB) of Carfilzomib|The plasma protein binding (PPB) of carfilzomib in plasma samples was determined using a rapid equilibrium dialysis (RED) device. Data are averages of the 3 time points (Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15).|End of injection and 5 minutes post-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15|Participants with available data|||percentage of carfilzomib bound||Standard Deviation|Mean
1222096|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
1222097|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
1222098|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
1222099|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
1222100|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222101|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222102|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222103|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222104|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222105|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population; AUCinf could not be estimated for 11 participants in the PK population who did not have adequate PK data.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222106|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222107|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222108|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222109|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data|||liters/hour||Standard Deviation|Mean
1222110|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data|||liters/hour||Standard Deviation|Mean
1222113|NCT00721630|Primary|Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|6 months||||Participants|||Count of Participants
1222114|NCT00721617|Secondary|C-peptides Levels for Intralipid/Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
1222115|NCT00721617|Secondary|C-peptides Levels for Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
1222116|NCT00721617|Secondary|C-peptides Levels for Intralipid Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after Intralipid infusion, and 8 hours after Intralipid infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
1222117|NCT00721617|Secondary|C-peptides Levels for Saline Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
1222118|NCT00721617|Secondary|Insulin Levels for Intralipid/Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
1222119|NCT00721617|Secondary|Insulin Levels for Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
1222120|NCT00721617|Secondary|Insulin Levels for Intralipid Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
1222134|NCT00721617|Primary|Change in Flow-mediated Dilation From Baseline to 4 Hours|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.|Baseline, 4 hours||||percent change in diameter||Standard Deviation|Mean
1222121|NCT00721617|Secondary|Insulin Levels for Saline Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
1222122|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid/Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
1222123|NCT00721617|Secondary|Plasma Glucose Levels for Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
1222124|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 8 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 8 hours||||mmHg||Standard Deviation|Mean
1222125|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 4 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 4 hours||||mmHg||Standard Deviation|Mean
1222126|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
1222127|NCT00721617|Secondary|Plasma Glucose Levels for Saline Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
1222128|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 8 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 8 hour triglyceride levels from baseline triglyceride levels.|Baseline, 8 hours||||mg/dL||Standard Deviation|Mean
1222129|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 4 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 4 hour triglyceride levels from baseline triglyceride levels.|Baseline, 4 hours||||mg/dL||Standard Error|Mean
1222130|NCT00721617|Secondary|Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 8 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change iis the difference between 8 hour FFA levels from baseline FFA levels.|Baseline, 8 hours||||mmol/L||Standard Deviation|Mean
1222131|NCT00721617|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 4 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 4 hour FFA levels from baseline FFA levels.|Baseline, 4 hours||||mmol/L||Standard Deviation|Mean
1222132|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 8 Hours|Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 8 hours||||mmHg||Standard Error|Mean
1222133|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 4 Hours|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 4 hours||||mmHg||Standard Error|Mean
1222216|NCT00721188|Secondary|Volume of Distribution Based on the Terminal Phase (Vdarea)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
1222138|NCT00721578|Primary|Number of Participants With Mycological Outcomes|"Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy~), or unknown (results are not available/not known) as assessed by the Investigator/Physician."|Up to 9 months|FAS.|||Participants|||Number
1222139|NCT00721578|Primary|Number of Participants With Clinical Outcomes.|"Clinical outcomes, as assessed by the investigator, defined as:~Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period.~Deteriorated: clinical signs and symptoms of fungal infection worsened (including death).~Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation."|Up to 9 months|FAS.|||Participants|||Number
1222140|NCT00721578|Primary|Total Daily Dose for Selected Antifungal Agent||Up to 9 months|FAS. Data were not analyzed.|||mg|||Number
1222141|NCT00721578|Primary|Management of SFI: Reason for Selection of Antifungal Agent|Number of participants with reason for investigator's selection of particular antifungal therapy.|Up to 9 months|FAS. Data were not analyzed.|||Participants|||Number
1222142|NCT00721578|Primary|Management of SFI: Choice of Treatment|Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.|Up to 9 months|FAS.|||Participants|||Number
1222143|NCT00721578|Primary|Diagnosis of Systemic Fungal Infection (SFI)|Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.|Up to 9 months|Full analysis set (FAS) = all enrolled participants who received at least one dose of antifungal therapy. n = number of participants who had microbiological assessments performed. SOT = start of treatment, EOT = end of treatment|||Participants|||Number
1222144|NCT00721539|Secondary|Average Operative Time|Average operative time in minutes|Up to four hours (240 minutes)|Participants|||Minutes||Full Range|Mean
1222145|NCT00721539|Secondary|Average Blood Loss|Blood lost during procedure|Duration of procedure up to two hours|Participants|||mL||Full Range|Mean
1222146|NCT00721539|Secondary|Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure||Six weeks|Adult patients 18 years of age and over|||Participants|||Number
1222147|NCT00721539|Primary|Overall Complication Rate (Intraoperative and Postoperative)|Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.|Six weeks|Subjects enrolled in this pilot study.|||Participants|||Number
1222148|NCT00721500|Primary|Lens Tightness on Cornea With Manual Digit Push Up|Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||percentage|Participants|Standard Deviation|Mean
1222149|NCT00721500|Primary|Lens Fit Decentration|Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||mm|Participants|Standard Deviation|Mean
1222150|NCT00721500|Primary|Proportion of Eyes Successfully Fit|Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||proportion of participant eyes|Participants||Number
1222151|NCT00721409|Secondary|Number of Participants With Treatment-Related Adverse Events at Phase 2|AE: any untoward medical occurrence in a participant who received study drug. AEs included both serious and non-serious adverse events. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs: events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Treatment related AEs: all AEs with causality related to treatment. Relatedness to drug was assessed by the investigator. AEs were graded according to the CTCAE version 3.0 and coded using the MedDRA. Number of participants with AE of grade 3 or 4 and with AE of grade 5 were reported as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE.|Baseline up to 28 days after last dose of study drug (for a maximum of 86 months)|All treated as treated set included all treated participants classified by the treatment actually received.|||Participants|||Count of Participants
1222152|NCT00721409|Secondary|Number of Participants With TEAEs (All Causalities) at Phase 2|AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.AEs included both serious and non-serious AEs.SAE:AE resulting in any of following outcomes/deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience (immediate risk of dying);persistent or significant disability/incapacity;congenital anomaly.Treatment emergent AEs:events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or worsened relative to pre-treatment state.AEs were graded as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and coded using Medical Dictionary for Regulatory Activities (MedDRA). Participants with AE of grade 3 or 4 and grade 5 were reported as Grade 3:Severe, Grade 4:Life threatening, Grade 5:Death related to AE.|Baseline up to 28 days after last dose of study drug (for a maximum of 86 months)|All treated as treated set included all treated participants classified by the treatment actually received.|||Participants|||Count of Participants
1222217|NCT00721188|Secondary|Initial Volume of Distribution (Vdc)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
1222153|NCT00721409|Secondary|Percentage of Participants With Tumor Expression of CYP19A1 and CCND1 Genotypes at Phase 2|One 2-mL blood specimen was collected for the analysis of germline polymorphism in CYP19A1 and CCND1 genes. A single nucleotide polymorphism (SNP) rs4646 as defined in the National Center for Biotechnology Information (NCBI) database in the aromatase gene (CYP19A1) was analyzed. A germline polymorphism G/A870 (rs9344) in the CCND1 gene was analyzed.|Screening visit (≤ 28 Days prior to dosing)|Polymorphism analysis set included participants in the safety analysis set who had at least 1 polymorphism assessment.|||Percentage of participants|||Number
1222154|NCT00721409|Secondary|Summary of Copy Number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) at Phase 2|Gene copy number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) were evaluated. This analysis was done for Phase 2 combined group.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.|||Copy number||Standard Deviation|Mean
1222155|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Tumor Retinoblastoma (RB) and CyclinD1|Presence or absence of tumor RB and CyclinD1 were evaluated. The following definitions of expression applied in the below table: Positive: any expression >0 and Negative: any expression=0.|Screening visit (≤ 28 Days prior to dosing)|Protein biomarkers analysis set included all participants in the safety analysis set who had at least protein biomarker assessment.|||Participants|||Number
1222156|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Ki67|Frequency of tumor tissue biomarker Ki67 was evaluated in across treatment groups.|Screening visit (≤ 28 Days prior to dosing)|All participants in the Safety Analysis set who had a Ki67 protein biomarker assessment.|||Participants|||Number
1222157|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - p16/INK4A, CCND1|Tissue samples were used for retrospective biomarker analyses. For Phase 2 Part 2, the tissue samples were sent to a central laboratory for the assessment of participant selection biomarkers. For Phase 2 Part 1, the assessment of the biomarkers (CCND1 amplification and/or loss of p16) were performed retrospectively from the available samples.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.|||Participants|||Number
1222158|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Interference Scale (mBPI-sf) Questionnaire at Phase 2|The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (“no pain” or “does not interfere”) to 10 (“pain as bad as you can imagine” or “completely interferes”).|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.|||Units on a scale||Standard Error|Mean
1222159|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Severity Scale (mBPI-sf) Questionnaire at Phase 2|The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (“no pain” or “does not interfere”) to 10 (“pain as bad as you can imagine” or “completely interferes”).|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.|||Units on a scale||Standard Error|Mean
1222160|NCT00721409|Secondary|Time to Tumor Progression (TTP) at Phase 2-Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1222161|NCT00721409|Secondary|Number of Participants With CBR at Phase 2 - Investigator Assessment|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized patients from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Percentage of participants||95% Confidence Interval|Number
1222162|NCT00721409|Secondary|Duration of Response at Phase 2 - Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|A subset of ITT population i.e., participants who had response was used for this analysis.|||Months||95% Confidence Interval|Median
1222218|NCT00721188|Secondary|Total Body Clearance (Cl)|Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)|Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.||||dL/hour||Standard Deviation|Mean
1222163|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response in Participants With Measurable Disease at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions. Measurable disease referred to the lesions that was accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10-16 mm with spiral computer tomography scan (depending on reconstruction interval). Clinical lesions were only be considered measurable when they were superficial (eg, skin nodules, palpable lymph nodes).|From randomization up to the end of treatment (approximately 41 months)|Participants in ITT population with measurable disease were used.|||Percentage of participants||95% Confidence Interval|Number
1222164|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Percentage of participants||95% Confidence Interval|Number
1222165|NCT00721409|Secondary|Overall Survival (OS) at Phase 2|Time in weeks or months from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7 or 30.44 if in months.|From randomization until death (assessed up to 86 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1222166|NCT00721409|Secondary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval at Phase 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR), by Bazette’s formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|Cycle 1 Day 1 prior to dosing, Cycle 1 Day 14 (2, 4 [prior to meal], 8, 24, 48, and 96 hours after dosing of Palbociclib), Cycle 2 Day 1 and Day 14 (prior to and 4 hours after dosing of letrozole)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
1222167|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Tmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Full Range|Median
1222168|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Cmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222169|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: AUC24 at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1222170|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Volume of Distribution (Vz/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||L||Geometric Coefficient of Variation|Geometric Mean
1222171|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Clearance (CL/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1222172|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Terminal Plasma Half-life (t1/2) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Standard Deviation|Mean
1222173|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Time to Maximum Plasma Concentration (Tmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Full Range|Median
1222174|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Maximum Observed Plasma Concentration (Cmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222175|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC24) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1222176|NCT00721409|Secondary|Percentage of Participants With Clinical Benefit Response (CBR) at Phase 1|CBR is defined as a confirmed CR, confirmed PR, or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 weeks after initial response.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.|||Percentage of participants||95% Confidence Interval|Number
1222177|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Tumor Response at Phase 1|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.|||Percentage of participants||95% Confidence Interval|Number
1222178|NCT00721409|Primary|Progression-Free Survival (PFS) at Phase 2 - Investigator Assessment|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Weeks or Months) = (first event date minus randomization or the first dose date plus 1) divided by 7 (or 30.44 if in months). PFS is usually characterized by the median, 25% percentile,75% percentile and their 95% Confidence Intervals (CIs).|From randomization date to date of first documentation of progression or death (assessed up to 41 months)|Intent-to-Treat (ITT) was used. This represented all randomized participants from Ph2P1 or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1222219|NCT00721188|Primary|Terminal Phase Elimination Rate Constant (λz)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||1/hour||Standard Deviation|Mean
1222179|NCT00721409|Primary|Number of Participants With Dose Limiting Toxicities at Phase 1|Dose limiting toxicity was defined as any of the following TEAEs occurring during the second cycle of treatment and possibly attributable to the combination of letrozole plus Palbociclib: 1. Grade 4 hematologic toxicity (including platelets <25,000/μL, ANC <500/μL). 2. Grade 3 neutropenia associated with a documented infection or fever ≥38.5°C. 3. Grade ≥3 non-hematologic toxicities, except those that have not been maximally treated (eg, nausea, vomiting, diarrhea, hypertension). 4. Delay by ≥1 week in receiving the next scheduled dose of either study treatment due to persisting treatment-related toxicities (platelet count <50,000/μL; ANC <1,000/μL; nonhematologic toxicities of Grade ≥3 severity). 5. Inability to deliver at least 80% of the planned Palbociclib or letrozole doses during Cycle 2 due to toxicity possibly attributable to the study treatment.|Cycle 2 (4 weeks)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
1222180|NCT00721409|Primary|Number of Participants With Treatment-Related Adverse Events at Phase 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
1222181|NCT00721409|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) at Phase 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
1222182|NCT00721396|Secondary|Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.|"Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline.~Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies."|1 month after 3rd vaccination||||Percentages of subjects||95% Confidence Interval|Number
1222183|NCT00721396|Secondary|Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|One month after third Men B vaccination|PP Population|||Percentages of subjects||95% Confidence Interval|Number
1222184|NCT00721396|Secondary|Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.|The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.|One month after third Men B vaccination|PP Population|||Percentages of subjects||95% Confidence Interval|Number
1222185|NCT00721396|Secondary|Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|one month after third Men B vaccination|PP Population|||Ratio||95% Confidence Interval|Geometric Mean
1222186|NCT00721396|Secondary|Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.|One month after third Men B vaccination|PP Population|||Titers||95% Confidence Interval|Geometric Mean
1222187|NCT00721396|Secondary|Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine|Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.|One month after 3rd vaccination|All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis: Per Protocol (PP) Population.|||Percentages of subjects||95% Confidence Interval|Number
1222188|NCT00721396|Secondary|Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age|The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.|One month after 3rd Men B vaccination|Analysis was done on the per-protocol population i.e all subjects in the MITT population who received all the relevant doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
1222220|NCT00721188|Primary|Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug/dL||Standard Deviation|Mean
1222189|NCT00721396|Primary|Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age|Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357).|10 months (groups 1 and 2); 8 months (groups 3 and 4)|All subjects receiving at least one injection and providing post-baseline safety data (Safety Set).|||Number of subjects|||Number
1222190|NCT00721396|Primary|Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine|"The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).~The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains."|One month after third Men B vaccination|The analysis was done on the Modified Intention to Treat (MIIT) population, ie, enrolled subjects who actually received a study vaccination and provided at least one evaluable serum sample after baseline.|||Percentages of subjects||95% Confidence Interval|Number
1222191|NCT00721357|Secondary|Magnetic Resonance Spectroscopy of Muscle Metabolic Properties||within one week of enrollment|||||||
1222192|NCT00721357|Secondary|Muscle Mechanical Energy Expenditure|mechanical work done by lower extremity joints|one time measure||2015-12-31|12/2015||||
1222193|NCT00721357|Primary|Oxygen Consumption During Walking|Amount of oxygen consumed during walking at self-selected speed normalized to speed|within one week of enrollment||||ml/kg/min||Standard Deviation|Mean
1222194|NCT00721279|Primary|Correlation of the Change in IRLS at End of Titration and at Final Visit|Correlation of the change in IRLS at end of titration and at final visit|Up to 12 weeks|Full Analysis Set (FAS)|||percentage of patients|||Number
1222195|NCT00721279|Primary|Frequency of Adverse Events|Frequency of patients with any adverse event, causally related adverse events and serious adverse events|Up to 16 weeks|Safety Analysis Set (SAF)|||participants|||Number
1222196|NCT00721279|Primary|Change in Global Clinical Impression - Improvement (CGI-I) Scale|The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient’s illness has improved or worsened relative to a baseline state. A patient’s illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse|baseline and final visit (week 12)|Full analysis set|||percentage of participants|||Number
1222197|NCT00721279|Primary|Change in Total Scores of IRLS (International Restless Legs Rating Scale)|"The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.~The change from baseline was calculated as baseline minus the week 12 value."|Baseline and final visit (week12)|Only those patients of the full analysis set with an evaluation of the IRLS at visit 3 were included|||scores on a scale||Inter-Quartile Range|Median
1222198|NCT00721279|Primary|Frequency Analysis for Baseline Pattern of RLS Symptoms|Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.|Baseline|Full analysis set (FAS)|||percentage of participants|||Number
1222199|NCT00721253|Secondary|Defocus Curve|Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months post-operative||||logMAR||Standard Deviation|Mean
1222200|NCT00721253|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 months||||log units||Standard Deviation|Mean
1222201|NCT00721253|Primary|Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate|Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.|6 months||||logMAR||Standard Deviation|Mean
1222202|NCT00721227|Secondary|Weight Loss Following Reduction Gastroplasty|Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.|12 months|Includes only participants who completed month 12 visit.|||Percentage of weight loss||Standard Deviation|Mean
1222203|NCT00721227|Secondary|Durability of Gastric Plications Following Reduction Gastroplasty|The number of participants who completed month 12 gastroscopies showing intact plications.|12 month|Includes only participants who completed month 12 gastroscopy.|||participants|||Number
1222204|NCT00721227|Primary|Successful Gastric Plication Using Reduction Gastroplasty|The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.|Immediately post-operative||||participants|||Number
1222221|NCT00721188|Primary|Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug*hr/dL||Standard Deviation|Mean
1222222|NCT00721188|Primary|Serum Terminal Phase Elimination Half-life (T1/2)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
1222205|NCT00721214|Secondary|Two-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with two year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two- year event-free survival rate is the same as for overall survival, 37% (SE = 14.3%).|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1222206|NCT00721214|Secondary|One-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with one year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated one-year event-free survival rate is the same as for overall survival, 47% (SE = 13.6%).|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1222207|NCT00721214|Secondary|Two-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts.|Percentage of participants alive two years after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two year survival rate is 37% .The estimated two-year overall survival rate is the same as two-year event free survival.|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1222208|NCT00721214|Primary|Two Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival. The percentage of patients was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated two-year event-free survival rate is the same as overall survival, 50%.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
1222209|NCT00721214|Primary|One Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival, as estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated one-year event-free survival rate is the same as overall survival, 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
1222210|NCT00721214|Primary|Two Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive two years after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated two year survival rate is 50%, the same as one year survival rate.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
1222211|NCT00721214|Secondary|One-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants alive one year after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored. The estimated one year overall survival rate from this curve is 47%. The one year overall survival is the same as one year event free survival rate.|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1222212|NCT00721214|Primary|One Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive one year after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated one year survival rate from this curve is 50%, while the estimated two year survival rate is 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
1222213|NCT00721188|Secondary|Number of Participants With Serious Adverse Events (SAE's)||Day of initial treatment with Venofer through 30 days after study treatment||||participants|||Number
1222214|NCT00721188|Secondary|Mean Residence Time (MRtime)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
1222215|NCT00721188|Secondary|Volume of Distribution at Steady State (Vdss)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
1222225|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.|at 2 weeks and 4 weeks after stent insertion|91 participants who had successful stent insertion were analyzed based on per protocol analysis.|||proportion of participants||95% Confidence Interval|Mean
1222226|NCT00721175|Secondary|Cost Effective Ratio of Metallic and Plastic Stent|cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature|until the patients expire (Markov model)|Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma|||cost (US$) per QALY|||Number
1222227|NCT00721175|Secondary|Patients Survival Times|survival times of the patients after the first stent insertion|until patient died or 6 months after the last patient was enrolled||||days||Inter-Quartile Range|Median
1222228|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.|at 2 weeks and 4 weeks after stent insertion|All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)|||proportion of participants||95% Confidence Interval|Mean
1222229|NCT00721162|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 30 months|All participants who received any amount of study drug.|||participants|||Number
1222230|NCT00721162|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 43.9 months|All participants who received any amount of study drug. The number of participants censored was 12.|||months||95% Confidence Interval|Median
1222231|NCT00721162|Secondary|Overall Survival at 1 Year (OS-1)|Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.|First dose to 12 months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1222232|NCT00721162|Secondary|Progression-Free Survival (PFS)|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 34.6 months|All participants who received any amount of study drug. The number of participants censored was 11.|||months||95% Confidence Interval|Median
1222233|NCT00721162|Primary|Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)|Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1222234|NCT00721162|Primary|Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)|Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.|First Dose to 6 Months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1222235|NCT00721149|Secondary|Percentage of Subjects Who Responded to Quality of Life Assessment|SF 36 Symptom Frequency and Severity Checklist|1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
1222236|NCT00721149|Secondary|TTM Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
1222237|NCT00721149|Secondary|24-hour Holter Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
1222238|NCT00721149|Secondary|Percentage of Subjects Who Achieved Acute Success|Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.|Day 91 - 361|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
1222257|NCT00721110|Secondary|Verbal Response Fatigue Score on Postoperative Day 1|Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.|postoperative day 1|11 patients had missing POD 1 fatigue scores (e.g., 11 for lidocaine vs. nonlidocaine and 11 for ketamine vs. nonketamine).|||units on a scale||Standard Deviation|Mean
1222239|NCT00721149|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.|within 7 days of ablation procedure|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
1222240|NCT00721149|Primary|Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.|A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).|From study day 91 through day 361|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
1222241|NCT00721136|Primary|Anticoagulant Related Complications|Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia|30 days||||participants|||Number
1222242|NCT00721136|Primary|Thromboembolic Events||30 days||||participants|||Number
1222243|NCT00721136|Primary|Bleeding Complication|Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.|30 days|Baseline characteristics of both groups were well matched except that patients randomized to warfarin discontinuation were more obese (P = .024).|||participants|||Number
1222244|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks|The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Percentage of Participants|||Number
1222245|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks|"Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis.~FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Percentage of Participants|||Number
1222246|NCT00721123|Primary|Overall Death Rate Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1.~To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure."|through 264 Weeks|All exposure population, which included all participants who entered the study and received at least one dose of tocilizumab at any time.|||Deaths per 100 PY||95% Confidence Interval|Number
1222247|NCT00721123|Primary|Summary Adverse Event Rates Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied.~Abbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed “unrelated” to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity.~Medical confirmation of the AESI GI perforation was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Adverse Events per 100 Patient Years||95% Confidence Interval|Number
1222248|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks|The patient’s assessment of the patient's current level of pain on a 100 mm horizontal VAS was recorded. The extreme left end of the line was described as “no pain” and the extreme right end as “unbearable pain”. Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
1222258|NCT00721110|Secondary|Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day||2 hours after surgery, on postoperative day 1||||percentage of participants|||Number
1222259|NCT00721110|Secondary|Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2||intraoperative through postoperative day 2||||milligram morphine sulfate equivalents||Inter-Quartile Range|Median
1222249|NCT00721123|Secondary|Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks|Physician’s global assessment of disease activity is the treating physician’s assessment of the patient’s current disease activity on a 100 mm horizontal visual analogue scale (VAS). The extreme left end of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end as “maximum disease activity”. Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
1222250|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks|Patient’s global assessment of disease activity is the patient’s overall assessment of their disease activity during specified time periods on a 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme as “maximum disease activity” (maximum arthritis disease activity). Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
1222251|NCT00721123|Secondary|Change From Baseline in Scores for Health Assessment Questionnaire − Disability Index Over Time, Through 264 Weeks|"The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.~To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
1222252|NCT00721123|Secondary|Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks|"Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement.~A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Joints||Standard Deviation|Mean
1222253|NCT00721123|Secondary|Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks|Participants were classified as responders based on a European League Against Rheumatism (EULAR) response of Good or Moderate. Comparing the DAS28 from one patient on two different time points, it is possible to define improvement or response. The EULAR response criteria take into consideration both the first score and the change in score in order to classify them as good response, moderate response or no response. The percentage of participants who were classified as responders was recorded, as posted below.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Percentage of Participants|||Number
1222254|NCT00721123|Secondary|Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks|The disease activity score 28 (DAS28) is a combined index for measuring disease activity in rheumatic arthritis (RA) that includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The DAS28 scale ranges from 0 to 10, where lower scores represent less disease activity. Participants with DAS28 scores less than 2.6 were categorized as responders with remission and those with DAS 28 scores of 3.2 or less were categorized as responders with low disease activity (LDA). The percentage of participants classified as responders in each category was recorded over time.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Percentage of Participants|||Number
1222255|NCT00721123|Secondary|Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks|"The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire.~Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms.~Scores on the ACR scale may be up to ACR100 because the number after “ACR” is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score – that percentage of improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab, with a score at the given time point.|||Percentage of Participants|||Number
1222256|NCT00721123|Primary|Adverse Event (AE) Summary Over Time|The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Participants|||Number
1223632|NCT00711009|Secondary|Mean Change From Baseline in Basophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1222260|NCT00721110|Secondary|Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2|Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.|PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2||||units on a scale||Standard Deviation|Mean
1222261|NCT00721110|Primary|The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two|The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.|postoperative day 2||||meters||Standard Deviation|Mean
1222262|NCT00720941|Secondary|MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.|Weeks 4, 10, 16, and 22|ITT Population. Only those participants who had NSLVs, NSRVs, HHVs, and medical procedures were analyzed.|||visits||Standard Deviation|Mean
1222263|NCT00720941|Secondary|Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24|Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician’s assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.|From Day 1 up to Week 24|ITT Population. Only those participants who had non-study medical visits, telephone consulations, days in the hospital, and ER visits were analyzed.|||events per 30 days||Standard Deviation|Mean
1222264|NCT00720941|Secondary|Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The CTSQ assesses 3 domains related to the participant’s satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.|Weeks 4, 10, 16, and 22|ITT Population. Participants missing scores at early time points were excluded from the analysis at those time points. Mean total score was calculated at each assessment week.|||Scores on a scale||Standard Deviation|Mean
1222265|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. assessed the limitations caused by their foot soreness by answering the question of In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
1222266|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants (par.) assessed the limitations caused by their mouth/throat soreness by answering the question of In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
1222273|NCT00720941|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.|Baseline (predose); Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at some of the other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
1222267|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of  In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness? by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1222268|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1222269|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions (I am able to work, I am able to enjoy life, and I am content with the quality of my life now) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1222270|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions (I have nausea, I have diarrhea, and I am bothered by side effects of treatment) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12).Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1222271|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument measuring disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of I worry that my condition will get worse by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
1222272|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions (I have a lack of energy, I feel pain, for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1222291|NCT00720798|Secondary|Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Joints||Standard Deviation|Mean
1222274|NCT00720941|Secondary|Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)|See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.|From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)|Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.|||Participants|||Number
1222275|NCT00720941|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)|ITT Population. Only those participants who had either a confirmed CR or PR were analyzed.|||Months||95% Confidence Interval|Median
1222276|NCT00720941|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)|ITT Population. Only those participants who experienced either a confirmed CR or a PR were analyzed.|||Weeks||95% Confidence Interval|Median
1222277|NCT00720941|Secondary|Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review|The number of participants with evidence of CR (the disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.|From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)|ITT Population|||Participants|||Number
1222278|NCT00720941|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death (up to Study Week 268)|ITT Population. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|||Months||95% Confidence Interval|Median
1222279|NCT00720941|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.|From randomization until the earliest date of disease progression or death (up to Study Week 191)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|||Months||95% Confidence Interval|Median
1222280|NCT00720876|Secondary|Number of Participants With Grade 3 and 4 Toxicities|Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 3.0.|3 weeks after the stop of treatment||||Participants|||Count of Participants
1222281|NCT00720876|Secondary|Progression-free Survival|Progression\Relapse is defined using the 2007 Cheson criteria, as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy; or at least a 50% increase for nadir in the SPD of any previously involved nodes; or at least a 50% increase in the longest diameter of any singe previously identified node more than 1 cm in its short axis. Estimated using the product-limit method of Kaplan and Meier.|Until disease progress\relapse, up to 1 year after the start of treatment||||Months||95% Confidence Interval|Median
1222282|NCT00720876|Primary|Overall Response Rate (Complete and Partial Response)|Response was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR.|After every 3 cycles, up to 1 year after the start of treatment||||percentage of participants|||Number
1222283|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264|The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1222284|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264|The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1222285|NCT00720798|Secondary|Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1222286|NCT00720798|Secondary|Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1222287|NCT00720798|Secondary|Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1222288|NCT00720798|Secondary|Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Erythrocyte sedimentation rate (ESR) was determined locally.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||mm/h||Standard Deviation|Mean
1222289|NCT00720798|Secondary|Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1222290|NCT00720798|Secondary|Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Participant’s made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). The participant’s treating physician made a global assessment of the participant’s current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). Participant’s made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated “no pain” (score = 0) and the right end of the scale indicated “unbearable pain” (score = 100).|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||mm||Standard Deviation|Mean
1222292|NCT00720798|Secondary|Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264|Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1222293|NCT00720798|Secondary|Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264|A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1222294|NCT00720798|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264|Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1222295|NCT00720798|Secondary|Percentage of Participants Who Changed From Monotherapy to Combination Therapy|Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator’s practice and as tolerated by the patient, at any time during this study.|Baseline to Week 296|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants from the core study WA17824 are included in the analysis.|||Percentage of participants|||Number
1222296|NCT00720798|Secondary|Percentage of Participants With Concomitant Oral Corticosteroid Therapy|"Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count.~The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months."|Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
1222297|NCT00720798|Secondary|Percentage of Participants Who Withdrew From Treatment||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
1222298|NCT00720798|Primary|Percentage of Participants With ≥ 1 Adverse Event||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
1222299|NCT00720759|Primary|Wolf Motor Function Test (Time)|The Wolf Motor Function Test (time) score is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one’s forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task. Score range on the WMFT-T is 0-120, lower scores being better.|3 months after completion of treatment||||units on a scale||Standard Deviation|Mean
1222300|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 2|Mean terminal half-life (±SD)|Up to 205 hours|All participants|||hours||Standard Deviation|Mean
1222301|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 1|Mean Cmax (±SD)|At 1 - 2 hours|All participants|||ng/mL||Standard Deviation|Mean
1222302|NCT00720629|Secondary|Overall Survival (OS)|Median OS in days. Survival was measured from the time of transplant to the time of death.|At 2 years and 5 years|Participants who had died by Year 2 and additional participants who had died by Year 5.|||days||Full Range|Median
1222303|NCT00720629|Secondary|Incidence of Rituximab Response to Reactivated EBV Without PTLD|"Participants who developed plasma EBV-DNA of >1000 copies/mL on any tests received rituximab.~Incidence of Rituximab Response: Reactivated EBV participants whose plasma titers cleared after rituximab, without post-transplant lymphoproliferative disorder (PTLD)."|100 days|Reactivated EBV participants|||participants|||Number
1222304|NCT00720629|Secondary|Incidence of Epstein-Barr Virus (EBV) Reactivation|Number of participants who reactivated EBV. Patients had their plasma tested once weekly using the TaqMan polymerase chain reaction (PCR) for quantitative determination of EBV-DNA for 6 weeks. Plasma levels > 1000 copies per ml plasma were scored as positive.|3 months|All participants|||participants|||Number
1222305|NCT00720629|Primary|Number of Participants With Grade II-IV Acute Graft-versus-Host Disease (GVHD) Score at 100 Days|"Cumulative Incidence of Grade II-IV Acute GVHD Score at 100 Days. Investigators had planned to assess whether the grade of acute GVHD was decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors, from day of transplant up to one year. Study was closed during the first treatment stage and did not proceed to the second stage treatment comparison to ATG in combination with tacrolimus/methotrexate as originally planned.~Overall GVHD Grade: From Filipovich AH, Weisdorf D, Pavletic S, etal: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 11:945-955 (2005). Grade I: Skin Stage 1-2, Liver Stage 0, Gut State 0; Grade II: Skin Stage 3 or, Liver Stage 1 or, Gut Stage 1; Grade II"|100 days|All participants|||participants|||Number
1222306|NCT00720499|Secondary|AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised)|"AUC (0-6h) for FEV1, and PEFR (unsupervised) after first dose and after 2 and 4 weeks of treatment were not analysed in the study report because the pertinent information from the unsupervised Pulmonary Function Tests (PFTs) was for the time interval from 6 to 12 hours post-dosing.~FVC peak 0-3h response after the first dose and at Week 2 (supervised) and AUC (6-12h) for FEV1 and PEFR after the first dose and at Week 2 (unsupervised) were not analysed in the study report.~Individual PEFR (supervised) measurements and individual FEV1 and PEFR (unsupervised) measurements at each time point were not analysed in the study report."|4 weeks|No patients analyzed in the study report.||||||
1222307|NCT00720499|Secondary|12-lead ECG QT Intervals|"12-lead ECG QT intervals baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1222308|NCT00720499|Secondary|12-lead ECG QTcB Intervals|"12-lead ECG heart rate corrected QT interval, using Bazett method (QTcB), baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1222309|NCT00720499|Secondary|12-lead ECG QTcF Intervals|"12-lead ECG corrected heart rate (QT) interval, using Fridericia method (QTcF), baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1222310|NCT00720499|Secondary|12-lead ECG QRS Intervals|"12-lead ECG QRS intervals baseline and change from baseline at other time points in milliseconds~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1222311|NCT00720499|Secondary|12-lead ECG PR Intervals|"12-lead ECG PR intervals baseline and change from baseline at other timepoints in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1222312|NCT00720499|Secondary|12-lead ECG Heart Rate|"12-lead Electrocardiogram (ECG) Heart rate baseline and change from baseline values at other time points in Beats Per Minute (BPM)~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||BPM||Standard Deviation|Mean
1222313|NCT00720499|Secondary|Overall Marked Changes From Baseline in Vital Signs|Overall marked changes from baseline in systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline to week 14|TS|||participants|||Number
1222314|NCT00720499|Secondary|Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination|Clinically significant abnormalities for blood chemistry, haematology, urinalysis and physical examination|14 weeks|Treated Set (TS) including all randomized patients who received at least one dose of study medication.|||participants|||Number
1222315|NCT00720499|Secondary|Physician’s Global Evaluation|"Physician’s global evaluation score on days 15 and 29~The score was evaluated on a 8-points scale :~Poor : 1,2~Fair : 3,4~Good : 5,6~Excellent : 7,8~The presented means are adjusted"|Days 15 and 29|FAS|||units on a scale||Standard Error|Mean
1222316|NCT00720499|Secondary|Patient Global Rating|"Patient global rating scores treatment comparison after 4 weeks~The score was evaluated on a 7-point scale :~1 : very much better~2 : much better~3 : a little better~4 : no change~5 : a little worse~6 : much worse~7 : very much worse~The presented means are adjusted."|4 weeks|FAS|||units on a scale||Standard Error|Mean
1222317|NCT00720499|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol])|"Weekly mean number of occasions of rescue therapy used per day (as occasion require (PRN) salbutamol [albuterol]) on weeks 1,2,3 and 4.~The means presented are the adjusted mean of weekly mean."|Weeks 1,2,3 and 4|FAS|||number of occasions / day||Standard Error|Mean
1222318|NCT00720499|Secondary|Weekly Mean Evening PEFR|"Weekly mean evening PEFR [L/min] on weeks 1,2,3 and 4.~The presented means are adjusted."|Weeks 1,2,3 and 4|FAS|||Litres / minute||Standard Error|Mean
1222320|NCT00720499|Secondary|PEFR AUC (6-12h) Response|"PEFR AUC (6-12h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29|FAS|||Litres / minute||Standard Error|Mean
1222321|NCT00720499|Secondary|PEFR Peak 0-3h Response|"PEFR peak 0-3h response [L/min] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres / minute||Standard Error|Mean
1222322|NCT00720499|Secondary|PEFR AUC (0-3h) Response|"Peak Expiratory Flow Rate (PEFR) AUC (0-3h) response [L/min] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres / minute||Standard Error|Mean
1222323|NCT00720499|Secondary|FVC Peak 0-3h Response|"FVC peak 0-3h response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1222324|NCT00720499|Secondary|FVC AUC (0-6h) Response|"FVC AUC (0-6h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1222325|NCT00720499|Secondary|FVC AUC (0-3h) Response|"FVC AUC (0-3h) response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
1222326|NCT00720499|Secondary|Individual FVC Measurements|"Individual FVC measurements [L] at each time point~The categories correspond to the planned times for FVC measurements on Day 29.~The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1222327|NCT00720499|Secondary|Trough FVC Response|"Trough Forced Vital Capacity (FVC) response [L] on days 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1222328|NCT00720499|Secondary|FEV1 (Unsupervised) AUC (6-12h) Response|"FEV1 (unsupervised) AUC (6-12h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|6 hours (h), 9h and 12h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1222329|NCT00720499|Secondary|FEV1, AUC (0-6h) Response|"FEV1, AUC (0-6h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1222330|NCT00720499|Secondary|FEV1 Peak 0-3h Response|"FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
1222331|NCT00720499|Secondary|FEV1 AUC 0-3h, Response|"FEV1 Area Under the Curve (AUC) 0-3h, response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
1222332|NCT00720499|Secondary|Individual FEV1 Measurements|"Individual FEV1 measurements [L] at each time point on Day 29.~The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1246045|NCT00537823|Primary|Major Postoperative Complication Rate|Fraction of patients with any complication grades IV and V|30 days following surgery|4 participants did not have surgery.|||percentage of participants|||Number
1222333|NCT00720499|Secondary|Trough FEV1 Response [L] After 2 Weeks of Treatment|"Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15|FAS|||Litres||Standard Error|Mean
1222334|NCT00720499|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.|"Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|Full analysis Set (FAS) which included all randomized patients who received at least one dose of study medication and had baseline data and Washout Period for at least 1 efficacy endpoint for each treatment period.|||Litres||Standard Error|Mean
1222335|NCT00720473|Primary|Means of MADRS Scores at 8 Weeks|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|8 Weeks|MADRS scores were available for 16 bipolar subjects who completed the protocol and 8 healthy controls.|||units on a scale||Standard Deviation|Mean
1222336|NCT00720473|Primary|Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|Baseline|MADRS scores were available for 27 eligible bipolar subjects and 14 eligible controls.|||units on a scale||Standard Deviation|Mean
1222337|NCT00720473|Primary|Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||NAA:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
1222338|NCT00720473|Primary|Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Gln:Cr/-10 MADRS Score||95% Confidence Interval|Least Squares Mean
1222339|NCT00720473|Primary|Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. The MADRS minimum score is 0 and maximum is 60, with 60 being the most depressed score. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 Weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Glu:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
1222340|NCT00720473|Primary|Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks||||NAA to creatine ratio||95% Confidence Interval|Least Squares Mean
1222341|NCT00720473|Primary|Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks||||serum Glutamine to Creatine ratio||95% Confidence Interval|Least Squares Mean
1222342|NCT00720473|Primary|Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 Weeks||||serum Glutamate to Creatine ratio||95% Confidence Interval|Least Squares Mean
1222343|NCT00720473|Primary|Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline|Estimated changes in least squares mean in the metabolite ratio per 10-point increase in MADRS score. The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|Baseline|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Glu:Cr/+10 MADRS||95% Confidence Interval|Least Squares Mean
1222344|NCT00720473|Primary|Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||Mean NAA to creatine ratio||Standard Deviation|Mean
1222345|NCT00720473|Primary|Mean Glutamate to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||mean serum Glutamate to Creatine ratio||Standard Deviation|Mean
1222346|NCT00720473|Primary|Mean Glutamine to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||mean serum Glutamine to Creatine ratio||Standard Deviation|Mean
1222347|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.|||log10 IU/mL||Standard Deviation|Mean
1222643|NCT00718315|Secondary|Time to Appearance of Skin Rash|Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE|Days 0, 15, and 30|ITT Population|||Days||95% Confidence Interval|Median
1222348|NCT00720434|Secondary|Population Pharmacokinetics (PK) of PF-00868554|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28|||||||
1222349|NCT00720434|Secondary|Alanine Aminotransferase (ALT) Levels||Week 4, 12, 48, 72|FAS included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
1222350|NCT00720434|Secondary|Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.|Week 4, 12, 48, 60, 72|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.|||proportion of participants||95% Confidence Interval|Number
1222351|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||log10 IU/mL||Standard Deviation|Mean
1222352|NCT00720382|Other Pre-specified|Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|change from baseline to 12 months||||Units on a scale||Standard Deviation|Least Squares Mean
1222353|NCT00720382|Primary|Change From Baseline on Direct Visual Nasal Exams to 12 Months|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|Change from baseline to 12 months||||Participants|||Number
1222354|NCT00720369|Secondary|We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.|"The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 question questionnaire which assesses symptom severity of depression. The score is on a 0-60 scale with higher numbers indicating more severe depressive symptoms. The score is represented as a number of points.~Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group."|8 week trial|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.|||units on a scale||Standard Deviation|Mean
1222355|NCT00720369|Primary|We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).|The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr <---> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.|8 week trial||||per second||Standard Deviation|Mean
1222356|NCT00720356|Post-Hoc|Median Progression Free Survival|Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.|From the start of treatment and every 2 cycles, where 1 cycle equals 28 days, during treatment. Median follow up at time of data was 33 months.|Two patients were not evaluable|||months||95% Confidence Interval|Median
1222357|NCT00720356|Post-Hoc|Overall Survival at 24 Months|Overall Survival (OS) will be measured from start of treatment until death of any cause|At 24 months from first treatment|Two patients were not evaluable|||percentage of patients|||Number
1222358|NCT00720356|Post-Hoc|Overall Survival at 12 Months|Overall Survival (OS) is measured from start of treatment until death from any cause.|At 12 months from start of treatment|Two patients were not evaluable|||percentage of patients|||Number
1222359|NCT00720356|Post-Hoc|Progression Free Survival at 6 Months|Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.|At 6 months from start of treatment|Two patients were not evaluable.|||percentage of patients|||Number
1222360|NCT00720356|Other Pre-specified|Gene Methylation Studies (Optional)|Tissue and plasma collected from consenting patients in the study will be used to correlate tumor tissue with imaging and outcomes. Tissue will be collected before treatment on study begins and plasma will be collected the first day of treatment (before treatment) and every odd cycle after that, whilst on study treatment. Tissue and plasma analysis will be correlated with patients imaging results and response to to treatment|At baseline and then plasma only will be collected every odd cycle (1 cycle = 28 days) during treatment for a maximum of 49 cycles.|This was an optional portion of the study for consenting patients. No data was collected and analyzed for this outcome measure.||||||
1222361|NCT00720356|Other Pre-specified|Changes in Tumor Blood Flow Based on MR Perfusion|Data from consenting patients will be used to assess of changes in tumor blood flow based on MR perfusion using MRI scans. Two scans will be completed prior to treatment on study; the first after surgery buta before radiation, the second within 14 days before starting combination treatment or erlotinib and bevacizumab. Then scans will be completed every 2 cycles during treatment, where one cycle equals 28 days.|Prior to study treatment (after surgery, but before radiation), just before study treatment (within 14 days prior to first treatment) and then every 2 cycles during study treatment, where 1 cycle equals 28 days for a maximum of 49 cycles.|This was an optional portion of the study that patients could participate in. Data was not collected or analyzed for this outcome measure.||||||
1222362|NCT00720356|Secondary|Progression Free Survival at 18 Months|Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.|At 18 months from start of treatment|Most patients had progressed before the 18 month time point. Data was not collected for PFS at 18 months.||||||
1222363|NCT00720356|Secondary|Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population|"Toxicity data for combination treatment of erlotinib and bevacizumab will be collected on day 1 of every cycle (1 cycle = 28 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|From the start of treatment, at the beginning of every cycle (1 cycle = 28 days) during treatment until 30 days after completion of treatment for up to 49 cycles.|All patients that received at least one dose of study drug were evaluable for toxicity. Data for grade 3 and 4 toxicities during treatment were collected.|||patients|||Number
1222364|NCT00720356|Secondary|Response Rate (RR)|"Response Rate (RR) will be defined as the best response seen during treatment measured by CT/MRI scan every 8 weeks during treatment using McDonald Criteria.~CR=Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients off steroids.~PR=Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable/decreased dose of steroids.~Stable/No Response=Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration. Stable/decreased dose of steroids.~Progressive disease = 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), worsening of evaluable disease, new lesions/site, failure to return for evaluation due to death or deteriorating condition."|From the start of treatment, every 2 cycles (1 cycle = 28 days) during treatment until progressive disease|Two patients were determined not to be evaluable (one patient withdrew consent from the study and one patient complete one cycle of treatment only)|||Participants|||Count of Participants
1222365|NCT00720356|Secondary|Progression-free Survival at 12 Months|Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.|At 12 months from start of treatment|Two patients were determined not to be evaluable (one patient withdrew consent from the study and one patient completed one cycle)|||percentage of patients|||Number
1222366|NCT00720356|Primary|Overall Survival|Overall survival (OS) will be measured from the start of treatment until death from any cause. At data cut off patients remaining alive will be censored at the last known date of contact.|From start of treatment, during treatment and every 3 months following the end of treatment until death. Median follow up at time of OS data was 33 months.|2 patients were not evaluable - 1 patient withdrew consent and 1 patient completed less than 1 cycle of treatment|||Months||95% Confidence Interval|Median
1222367|NCT00720343|Secondary|Prevalence of Opioid Use||24 hours after surgery|||||||
1222368|NCT00720343|Secondary|Prevalence of High Blood Choline Concentration||24 hours after surgery|||||||
1222369|NCT00720343|Secondary|Prevalence of Nausea||24 hours after surgery|||||||
1222370|NCT00720343|Primary|Prevalence of Pain||24 hours after surgery|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.||||||
1222371|NCT00720330|Secondary|Postoperative Nausea|Number of patients who had postoperative nausea or vomiting were recorded.|After surgery until the second postoperative day.||||Participants|||Count of Participants
1222372|NCT00720330|Secondary|Pain Scores on Numerical Rating Scale|Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings.|After surgery until the second postoperative mornings.||||units on a scale||Standard Deviation|Mean
1222376|NCT00720278|Secondary|Change From Baseline on Direct Visual Nasal Exams|"Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa.~Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation"|14 days||||Participants|||Number
1222377|NCT00720278|Secondary|Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 days||||28 item/7 domain RQLQ on 0-6 scale||Standard Deviation|Least Squares Mean
1222378|NCT00720278|Secondary|Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days||||Reflective secondary symptom score||Standard Deviation|Least Squares Mean
1222379|NCT00720278|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 Days||||total nasal symptom score||Standard Deviation|Least Squares Mean
1222380|NCT00720278|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days||||total nasal symptom score||Standard Deviation|Least Squares Mean
1222381|NCT00720226|Secondary|Change in FEV1 (L)|Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.|Measured at Baseline and Month 12|Participants with 5-35% emphysema at baseline who had HRCT scans performed both at baseline and at 12 months.|||L (BTPS)||Standard Deviation|Mean
1222382|NCT00720226|Primary|Change in Percent Emphysema on CT Scan|Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.|Change between baseline and month 12.|Participants with 5-35% emphysema on baseline CT scan|||% Emphysema Whole Lung||Standard Deviation|Mean
1222383|NCT00720122|Primary|Change in Spine Bone Density (g/cm^2)|Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.|Baseline and 6 months|The study participants analyzed were those that completed the first 6 months of the study and had a bone density performed at the baseline visit and then again at the 6 month visit as per protocol.|||gm/cm^2||Standard Error|Mean
1222384|NCT00720109|Secondary|Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)|An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death.|From the time entry on study to first event or date of last follow-up, assessed up to 7 years|Included in the analysis are two patients who received the drug therapy but were not risk classified.|||percentage of patients||90% Confidence Interval|Number
1222385|NCT00720109|Secondary|Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation|A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.|At end of consolidation (at 11 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percentage of participants||90% Confidence Interval|Number
1222386|NCT00720109|Secondary|Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy|Percent of patients MRD Positive (MRD > 0.01%) at End of Induction.|At the end of induction therapy (at 5 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percentage of participants||90% Confidence Interval|Number
1222387|NCT00720109|Primary|Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events|Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)|Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)|||Pts with DLTs|||Number
1222388|NCT00720109|Primary|Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy|Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.|At 3 years|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percent probability||90% Confidence Interval|Number
1222389|NCT00720096|Secondary|Response Rate|Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score >/= 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.|1 year, 2 months|Data was not collected for this Pilot study, due to small sample size and early termination.||||||
1222390|NCT00720096|Primary|Interpret Genomic Array|Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.|1 year, 2 months|All patients enrolled 4/4 had biopsiable tumor and sufficient quantity and quality.|||Participants|||Number
1222391|NCT00720096|Primary|Assess Feasibility|Number of patients meeting 3 week feasibility window which was set as the benchmark.|1 year, 2 months|Patients whose information for treatment was available within the 3 week feasibility window which was set as the benchmark.|||Participants|||Number
1222392|NCT00720083|Primary|Disease-free Survival|This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.|From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.|||||||
1222393|NCT00720057|Secondary|Time to Onset of Effect|"Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both perceptible and meaningful pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them."|from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours|Efficacy analyses are based on ITT population (n=312).|||hours||Full Range|Median
1222394|NCT00720057|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).|at 24 hours postdose or immediately before first use of rescue medication|Efficacy analyses are based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
1222395|NCT00720057|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.|postdose to first use of rescue medication|Efficacy analyses are based on ITT population (n=312).|||hours||Full Range|Median
1222396|NCT00720057|Secondary|Summed Pain Intensity Difference at Specific Time Intervals|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.|0-16 hours post dose|Efficacy analyses were based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
1222397|NCT00720057|Secondary|Total Pain Relief (TOTPAR)|Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.|0-24 hours post dose|Efficacy analyses were based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
1222398|NCT00720057|Primary|Summed Pain Intensity Difference (SPID)|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.|0 to 24 hours post dose|Randomized population is defined as all subjects who signed informed consent form, completed the screening period, and were randomized. The ITT population is defined as all subjects who were randomized and received at least one dose of the study treatment. Efficacy analyses are based on the ITT population (n=312).|||units on a scale||Standard Deviation|Mean
1222399|NCT00719953|Primary|Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|Base line and 12 weeks||||Points on a scale||Standard Error|Mean
1222400|NCT00719914|Primary|Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)||30 days|study terminated due to low enrollment||||||
1222401|NCT00719901|Secondary|Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)|Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either “unrelated or unlikely to be related” to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.||||||
1222402|NCT00719901|Secondary|Time to Treatment Failure (Phase II)|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|Time from study entry to the date patients end treatment|No participants proceeded to Phase II for evaluation.||||||
1222403|NCT00719901|Secondary|Overall Survival (Phase II)|The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|No participants proceeded to Phase II for evaluation.||||||
1222404|NCT00719901|Secondary|Time to Progression (Phase II)|The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time from registration to the time of progression|No participants proceeded to Phase II for evaluation.||||||
1222644|NCT00718315|Primary|Percentage of Participants With Skin Rash Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death|30 Days|ITT Population|||percentage of participants|||Number
1222405|NCT00719901|Secondary|Number of Patients Who Have at Least a Partial Response (Phase I)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years||||participants|||Number
1222406|NCT00719901|Primary|Proportion of Patients Who Achieve a Partial Response or Better. (Phase II)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.||||||
1222407|NCT00719901|Primary|Number of Dose-limiting Toxicity (DLT) Incidents (Phase I)|DLT was defined as any events that is determined to be possibly, probably, or definitely related to the combination of bortezomib and GX15-070 (as determined by the investigator) and occurring during the first cycle of treatment, irrespective of whether the toxicity resolved. Hematologic DLT measures were assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via Common Terminology Criteria for Adverse Events (CTCAE) version 3 standard toxicity grading.|Up to 21 days of every first course||||Toxicity Incidents|||Number
1222408|NCT00719862|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None,Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days||||Participants|||Number
1222409|NCT00719862|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Total overall score is not calculated by adding all subscales scores for an overall score. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days||||Units on a scale||Standard Deviation|Least Squares Mean
1222410|NCT00719862|Secondary|Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days||||Refecltive secondary symptom score||Standard Deviation|Least Squares Mean
1222411|NCT00719862|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days||||total nasal symptom score||Standard Deviation|Least Squares Mean
1222412|NCT00719862|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days||||scores on a scale||Standard Deviation|Least Squares Mean
1222413|NCT00719862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days||||scores on a scale||Standard Deviation|Least Squares Mean
1222414|NCT00719849|Secondary|Incidence of Relapse at 2 Years|"Number of participants with relapse at 2 years.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated."|2 years post transplant||||Participants|||Count of Participants
1222415|NCT00719849|Secondary|Incidence of Relapse at 1 Year|"Number of participants with relapse at 1 year.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated."|1 year post transplant||||Participants|||Count of Participants
1222416|NCT00719849|Secondary|Probability of Progression-free Survival at 2 Years|Kaplan-Meier estimate of the probability of progression-free survival at 2 years|2 years post transplant||||progression free survival probability||95% Confidence Interval|Number
1222417|NCT00719849|Secondary|Probability of Progression-free Survival at 1 Year|Kaplan-Meier estimate of the probability of progression-free survival at 1 year|1 year post transplant||||progression free survival probability||95% Confidence Interval|Number
1222421|NCT00719849|Secondary|Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year|"Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year.~Clinical Limited cGVHD~Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD.~Mild liver test abnormalities (alkaline phosphatase <2 x upper limit of normal, AST or ALT <3 x upper limit of normal and total bilirubin <1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD.~Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving <20% of body surface area (BSA), dyspigmentation involving <20% BSA, or erythema involving <50% BSA, positive skin biopsy, and no other manifestations of cGVHD.~Ocular sicca (Schirmer’s test <5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD.~Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD."|1 year post transplant||||Participants|||Count of Participants
1222422|NCT00719849|Secondary|Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100|"Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)"|Day 100 post transplant||||Participants|||Count of Participants
1222423|NCT00719849|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100|"Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)"|Day 100 post transplant||||Participants|||Count of Participants
1222424|NCT00719849|Secondary|Incidence of Platelet Engraftment at 6 Months|Number of participants with platelet engraftment at 6 months|6 months post transplant||||Participants|||Count of Participants
1222425|NCT00719849|Secondary|Incidence of Neutrophil Engraftment at Day 42|Number of participants with neutrophil engraftment at day 42|Day 42 post transplant||||Participants|||Count of Participants
1222426|NCT00719849|Secondary|Chimerism|Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.|7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant||||Participants|||Count of Participants
1222427|NCT00719849|Secondary|Incidence of Non-relapse Mortality at 6 Months|Number of Participants with Non-relapse Mortality at 6 Months|6 months post transplant||||Participants|||Count of Participants
1222428|NCT00719849|Secondary|Probability of Survival at 2 Years|Kaplan-Meier estimate of the probability of survival at 2 years|2 years post transplant||||survival probability||95% Confidence Interval|Number
1222429|NCT00719849|Primary|Probability of Survival at 1 Year|Kaplan-Meier estimate of the probability of survival at 1 year|1 year post transplant||||survival probability||95% Confidence Interval|Number
1222430|NCT00719810|Secondary|Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|Clinically Evaluable (CE) patients (see previous definition) with MRSA isolated from screening culture of primary infection.|||Participants|||Number
1222431|NCT00719810|Primary|Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|The CE population included patients with a diagnosis of cSSSI who received at least 80% of study drug, had a test of cure (TOC) visit 14-21 days after the last dose of study drug, and who did not receive any concomitant, systemic antibacterial therapy with activity against the causative pathogen.|||Participants|||Number
1222432|NCT00719732|Primary|Uncorrected Visual Acuity (UCVA)|Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months||||logMAR||Standard Deviation|Mean
1222433|NCT00719706|Secondary|Phosphorus MRS Scans on 4T Scanner|Whole brain total NTP levels as measured by a phosphorus MRS scan on the 4T scanner. The data could range from 0 - 1, with 0 representing the lowest NTP level and 1 representing the highest NTP level.|Baseline to 12 weeks|At baseline, the number of participants analyzed was the number entered into the imaging portion of the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 10 participants in each category.|||units on a scale||Standard Deviation|Mean
1222434|NCT00719706|Primary|Clinical Global Impression-Severity|"Scores could range from 0 - 7 units on a scale, with 0 representing the least severe (Normal, not at all ill) and 7 representing the most severe (Among the most extremely ill patients)."|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
1222435|NCT00719706|Primary|The Young Mania Rating Scale|The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
1222436|NCT00719706|Primary|The Montgomery-Asberg Depression Rating Scale|Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
1222437|NCT00719706|Primary|The 25-Item Hamilton Depression Rating Scale.|Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.|Baseline to 15 Weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
1222438|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers|Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1222439|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters|Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1222440|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs|Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature.|At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1222441|NCT00719680|Secondary|Number of Subjects Reporting Mild, Moderate, or Severe Local AEs|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1222442|NCT00719680|Secondary|Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion|"The rate of AEs was the number of AEs over the number of infusions administered.~AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion."|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.|||AEs per infusion|Participants||Number
1222443|NCT00719680|Secondary|Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion|AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1222444|NCT00719680|Secondary|Relatedness and Severity of All AEs (Percentage of Total AEs)|"At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.|||percentage of total AEs|Participants||Number
1222445|NCT00719680|Secondary|Rate of All AEs by Relatedness and Severity|"The rate of AEs was the number of AEs over the number of infusions administered.~At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The All-Treated (AT) safety population comprised all subjects treated with the study medication during any study period.|||AEs per infusion|Participants||Number
1222446|NCT00719680|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
1222447|NCT00719680|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
1222448|NCT00719680|Secondary|Number of Days of Hospitalization Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days||Standard Deviation|Mean
1222449|NCT00719680|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
1222450|NCT00719680|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days||Standard Deviation|Mean
1222451|NCT00719680|Secondary|Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations|Mean of individual median total IgG trough concentration.|Before infusion at Weeks 1, 24, 48, 72, and 96|The ITT population comprised all subjects treated with study medication during any study period.|||g/L||Standard Deviation|Mean
1222452|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Per-Protocol Efficacy population comprised all subjects who completed at least 48 weeks of the efficacy period that started with the first IgPro20 dose in this study.|||infections per subject year|Participants||Number
1222453|NCT00719680|Secondary|Annualized Rate of Any Infection|The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||infections per subject year|Participants||Number
1222454|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Intention-to-Treat (ITT) population comprised all subjects treated with study medication during any study period.|||infections per subject year|Participants||Number
1222455|NCT00719615|Primary|Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups.|We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, & 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D < 30 ng/ml.|Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database|"This study is a pilot study to provide preliminary data. Per protocol, we accrued 37% of the sample size needed for a fully powered study. Using the outcome the proportion of persons with vitamin D deficiency, a sample size of 160 subjects (64 nodule, 64 remission, and 32 active) would achieve an 80% power to detect an effect size of 0.25."|||participants|||Number
1222456|NCT00719576|Secondary|Participants With Treatment-Emergent Adverse Events||Week 104||||Participants|||Count of Participants
1222457|NCT00719576|Secondary|Change From Baseline at Week 104 in the Remaining 3 Subscales of the KOOS Instrument (Activities of Daily Living, Knee-related Quality of Life, and Other Symptoms)|The KOOS is a validated knee-specific instrument developed to assess the patients’ opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems).|Baseline and Week 104||||units on a scale||Standard Deviation|Mean
1222458|NCT00719576|Secondary|Treatment Failure|"The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. As such, the number of participants with treatment failure is being reported.~Patients were considered as a treatment failure if all of the following 5 criteria were met:~Patient’s global assessment of their knee joint compared to Baseline was the same or worse~Physician’s global assessment of the patient’s knee joint compared to Baseline was the same, worse, or significantly worse.~Percent improvement from Baseline in KOOS Pain score was less than 10%.~Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.~The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or autologous cultured chondrocyte implantation."|Week 104||||Participants|||Count of Participants
1222459|NCT00719576|Secondary|Response Rate Based on KOOS Pain and Function (Sports and Recreational Activities) Scores at Week 104.|A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from Baseline|Week 104||||Participants|||Count of Participants
1222460|NCT00719576|Secondary|Assessment of Defect Fill by Magnetic Resonance Imaging (MRI)|"Number of participants with MRI degree of defect fill > 50%. Evaluation of MRI data was performed by independent central review blinded to the participant's treatment.~Appropriate MRI sequences were used to image cartilage repair tissue."|Week 104|Number of participants with MRI data at Week 104|||Participants|||Count of Participants
1222461|NCT00719576|Secondary|Histological Evaluation of Structural Repair of Evaluable Biopsies Harvested From the Core of the Index Lesion During Arthroscopy at Week 104|"The mean microscopic International Cartilage Repair Society (ICRS) II overall assessment score was used to assess the histology efficacy endpoint.~Scoring of the cartilage repair biopsies was completed using the ICRS II histology scoring system (Mainil-Varlet, 2010, Am J Sports Med) by 2 independent pathologists blinded to the patient’s assigned study treatment. This scoring system includes 14 parameters, comprising an overall assessment score reported here, as well as 13 other items related to chondrocyte phenotype, tissue structure, and other factors, each scored on a scale from 0 to 100 representing poor to good quality cartilage."|Week 104|includes all subjects with histology follow-up data|||units on a scale||Full Range|Least Squares Mean
1222484|NCT00719355|Primary|Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test|Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).|Baseline and 24 weeks|Data were analyzed on patients with at least 1 follow-up treadmill test from baseline.|||minutes||Standard Deviation|Mean
1222462|NCT00719576|Primary|Change From Baseline to Week 104 for the Participant's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational Activities) Scores.|The KOOS is a validated knee-specific instrument developed to assess the patients’ opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|Baseline and Week 104|All randomized patients|||units on a scale||Standard Deviation|Mean
1222463|NCT00719563|Secondary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and Week 4|The analysis was not able to be done due to the low numbers of minorities accrued.||||||
1222464|NCT00719563|Secondary|Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.|||units on a scale||Standard Deviation|Mean
1222465|NCT00719563|Secondary|Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.|||units on a scale||Standard Deviation|Mean
1222466|NCT00719563|Secondary|Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
1222467|NCT00719563|Secondary|Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
1222468|NCT00719563|Secondary|Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
1222469|NCT00719563|Secondary|Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
1222470|NCT00719563|Secondary|Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1222471|NCT00719563|Secondary|Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1222472|NCT00719563|Secondary|Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1222473|NCT00719563|Secondary|Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1222474|NCT00719563|Secondary|Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Week 1 to Week 8|Includes all participants that reported at least one value after baseline.|||participants|||Number
1222475|NCT00719563|Primary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1222476|NCT00719537|Primary|Incidence of Preeclampsia|Number of Participants with preeclampsia in second and third trimester of pregnancy.|second and third trimester of pregnancy|1 Participant withdrawn in aspirin and placebo group, one participant lost to followup in aspirin and progesterone group.|||Participants|||Count of Participants
1222477|NCT00719472|Secondary|Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)|Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS).|Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses.|||Percentage of participants|||Number
1222478|NCT00719472|Secondary|Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)|Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples.|Day 1 of Cycles 2 and either 6 or 8 (last cycle)|Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data.|||µg/mL||Standard Deviation|Mean
1222479|NCT00719472|Secondary|Duration of Rituximab Infusion Including Dose Interruption Times|The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported.|Day 1 of each of Cycles 1 to 6 or 8|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Minutes||Inter-Quartile Range|Median
1222480|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)||Cycle 2 through Cycle 6 or 8 (end of study)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Percentage of participants|||Number
1222481|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1||Cycle 1|Intent-to-treat (ITT) population: All patients who received at least 1 dose of rituximab regardless of infusion rate.|||Percentage of participants|||Number
1222482|NCT00719472|Primary|Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2|The percentage of patients who developed Grade 3 or 4 IRRs resulting from faster infusion of rituximab at Cycle 2 was assessed in patients who had previously received rituximab at the standard infusion rate without experiencing a Grade 3 or 4 IRR at Cycle 1. IRRs were a predefined list of Medical Dictionary for Regulatory Activities (MedDRA) terms for infusion-related adverse events occurring on the day of and/or the day after rituximab infusion. The list of IRR terms was compiled based on IRRs observed in the present and previous studies in which rituximab was infused at the standard rate.|Days 1 and 2 of Cycle 2|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Percentage of participants||95% Confidence Interval|Number
1222483|NCT00719355|Secondary|Onset of Claudication Pain During Constant Work Rate Treadmill Test|Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded.|At 24 weeks|Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test.|||minutes||Standard Deviation|Mean
1222488|NCT00719264|Secondary|Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab|This outcome measure was assessed continuously.|From the date of the first participant treated until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.|||weeks||Full Range|Median
1222489|NCT00719264|Secondary|Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
1222490|NCT00719264|Secondary|Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units|The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
1222491|NCT00719264|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths|Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.|From the first participant randomized until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.|||Participants|||Number
1222492|NCT00719264|Secondary|Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.|Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.|A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders.|||Months||95% Confidence Interval|Median
1222493|NCT00719264|Secondary|Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.|||Number of participants|||Number
1222494|NCT00719264|Secondary|Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.|Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
1222566|NCT00718809|Secondary|Overall Survival|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|Time from the date of registration to last reported date of survival, assessed up to 5 years|All patients who enrolled and received treatment|||months||95% Confidence Interval|Median
1222495|NCT00719264|Primary|Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
1222496|NCT00719212|Secondary|Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat|||months||95% Confidence Interval|Median
1222497|NCT00719212|Secondary|Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression.|"The GCIG criteria (November 2005) were used to define progressive disease, based on serum CA 125 levels, as follows:~Patients with elevated CA 125 pretreatment and normalization of CA 125 needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart or~Patients with elevated CA 125 pretreatment, which never normalizes needed to show evidence of CA 125 greater than, or equal to, two times the nadir value on two occasions at least 1 week apart or~Patients with CA 125 in the normal range pretreatment needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart."|Day 1 of each cycle|Intent To Treat|||months||95% Confidence Interval|Median
1222498|NCT00719212|Secondary|Overall Survival (OS) Investigator Assessment|Interval between the date of registration and the date of death|Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first|Intent To Treat|||months||95% Confidence Interval|Median
1222499|NCT00719212|Secondary|Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts|"RECIST(v1.0):~CR:disappearance of all target les°&non-target les°&normalization of tumor marker level~PR:at least 30% decrease in the sum of the LD of target les°-ref the baseline sum LD OR CR for target les°&incomplete resp/SD for non target les°~SD:insufficient shrinkage for PR or increase for PD-ref the smallest sum LD since ttmt started or Persistence of one/more non-target les°or/&maintenance of tumor marker level above the normal~CA125 level:~PR:elev of CA125 at baseline PR if a ≥ 50% decrease compared to baseline value observed on 2 consec assessmts drawn at least 1 wk apart~CR:elev of CA125 at baseline CR 2 CA125 below ULN observed on 2 consec assessmts drawn at least 1 wk apart~SD:neither CR/PR nor PD~Best overall resp of :~CR:if CR per RECIST & per CA125~PR:if CR per RECIST & PR per CA125 OR CR per RECIST and SD per CA125 with elev CA125 at baseline OR PR per RECIST & CR/PR or SD per CA125~SD:other cases not qualifying for progression-at least 24 wks"|At 16 weeks from registration|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
1222500|NCT00719212|Primary|Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria.|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.~CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:~PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart~CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
1222501|NCT00719212|Secondary|Time To Progression (TTP) Investigator Assessment|Interval from the date of registration to the date of disease progression Investigator assessment As per RECIST (v1.0), disease progression represented an increase of at least 20% in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat|||months||95% Confidence Interval|Median
1222502|NCT00719212|Primary|Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.~CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:~PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart~CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
1222503|NCT00719186|Secondary|Neonatal Complication Rate||September 2008 - December 2011|Neonatal complications reported per infant, an infant could have more than one complication.|||participants|||Number
1222504|NCT00719186|Secondary|Number of Serious Adverse Events||as few as 5 months, up to 16 months||||events|||Number
1222505|NCT00719186|Secondary|Number of Ovulations||as few as 5 months, up to 16 months||||ovulations|||Number
1222506|NCT00719186|Secondary|Number of Pregnancy||as few as 5 months, up to 16 months||||Participants|||Count of Participants
1222507|NCT00719186|Primary|Live Birth|The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring.|as few as 5 months, up to 16 months||||Participants|||Count of Participants
1222508|NCT00719160|Secondary|Gastric pH|"The American Heritage Dictionary defines pH as a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14. The normal pH range for stomach acid is between 1.5 and 3.5."|Day 5 of a high protein diet||||units on a scale of pH||Standard Error|Mean
1222509|NCT00719160|Primary|Percent Change in Intestinal Calcium Absorption|This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.|Day 5 of a high protein diet||||percentage of calcium absorption||Standard Error|Mean
1222510|NCT00719134|Secondary|Pain Free at 2 Hours After Treatment|A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.|2 hours after treatment|For the secondary endpoint, the proportion of patients who were free from pain 2 hours after treatment, we used a mixed-effects logistic regression model to analyze the individual dichotomous outcomes.|||percent of patients pain free||95% Confidence Interval|Number
1222511|NCT00719134|Primary|Change in Headache Intensity|The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).|2 hours after treatment|For the primary endpoint, change in headache intensity from baseline to 2 hours after treatment, we used generalized linear mixed models with a normal random component and a logarithmic link function to analyze the pain scores.|||percent change||95% Confidence Interval|Mean
1222512|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222513|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|"A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0.~This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups."|At Days 10 and 42|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222514|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1222515|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Day 0, Day 10, Day 42, Day 182 and Day 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1222516|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 0, 10, 42, 182, 549 and 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1222517|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 10, 42, 182 and 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1222518|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1222519|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1222520|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1222521|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1222522|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1222531|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
1222523|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1222524|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222525|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222526|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
1222527|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
1222528|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222529|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222530|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222564|NCT00718809|Secondary|Expected Toxicities Including Skin Rashes and Diarrhea|Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.|Up to 5 years|All patients|||participants|||Number
1222532|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222533|NCT00719043|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1222534|NCT00719043|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.|Within the 43-day (Days 0-42) post-vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1222535|NCT00719043|Primary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1222536|NCT00719043|Primary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1222537|NCT00719043|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1222538|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222539|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222540|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
1222541|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
1223633|NCT00711009|Secondary|Mean Change From Baseline in Eosinophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1222542|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222543|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1222544|NCT00718887|Secondary|Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results|Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes.|Day 1 through Week 48|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
1222545|NCT00718887|Secondary|Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug.|Continually from Day 1 through Week 48, and through 24-week follow-up period|"Participants who were randomized and received at least~1 dose of study drug."|||Participants|||Number
1222546|NCT00718887|Secondary|Number of Participants With Genotypic Resistance to Entecavir||At Week 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||Participants|||Number
1222547|NCT00718887|Secondary|Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion||At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||Participants|||Number
1222548|NCT00718887|Secondary|Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion||At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and who were HBeAg-positive at baseline. n=number of evaluable participants.|||Percentage of participants|||Number
1222549|NCT00718887|Secondary|Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT)|ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN|At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and whose ALT values were >1*ULN at baseline. n=number of evaluable participants.|||Percentage of participants|||Number
1222550|NCT00718887|Secondary|Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing|HBV=hepatitis B virus|At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||log10 IU/mL||Standard Deviation|Mean
1222551|NCT00718887|Secondary|Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing|HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
1222552|NCT00718887|Primary|Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing|HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 12 from Day 1|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
1222553|NCT00718861|Secondary|Change in Height at Years 7, 8 and 9 Relative to Year 6|Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with evaluable measurements at both Year 6 and the post-Year 6 visit, as determined by the analysis window.|||millimeters (mm)||Standard Error|Least Squares Mean
1222554|NCT00718861|Secondary|Mean of Time to First Clinical Fracture|The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.|over 3 years of study duration|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups.|||Days||Standard Error|Mean
1222565|NCT00718809|Secondary|Disease Control Rate|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.|Up to 5 years|All patients who enrolled and received treatment|||months||95% Confidence Interval|Median
1222555|NCT00718861|Secondary|Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6|Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.|Year 6 (extension 2 baseline), Year 9 (3 years of study duration)|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n= the number of patients with the event|||participants|||Number
1222556|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
1222557|NCT00718861|Secondary|Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
1222558|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
1222559|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 – Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
1222560|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 – Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
1222561|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
1222562|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
1222563|NCT00718861|Primary|Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (baseline) and Year 9|The modified intent-to-treat (MITT) population included all patients in the ITT population who had DXA measurements of the total hip at Visit 11 (Year 6) and Visit 15 (Year 9). This was the primary population for the primary efficacy parameter.|||Percentage Change of BMD||Standard Error|Least Squares Mean
1222567|NCT00718809|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Time from the date of registration to the first reported outcome event, assessed up to 5 years|All patients who enrolled and received treatment.|||months||95% Confidence Interval|Median
1222568|NCT00718809|Primary|Objective Response Rate (Complete and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.|Up to 5 years|All patients with at least one post baseline measurement.|||percentage of participants||95% Confidence Interval|Number
1222569|NCT00718770|Primary|Change in Tumor Size|To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria|1 year|Adults with radioiodine resistant metastatic follicular cell derived thyroid cancer|||cm||Standard Deviation|Mean
1222570|NCT00718718|Secondary|Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)|Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.|Baseline, Week 2|Population analyzed included randomized participants in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
1222571|NCT00718718|Secondary|Serum Sirukumab Concentrations Through Week 38 (Part B)|Sirukumab Concentrations in serum were measured.|Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38|Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure whereas 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.|||Microgram per milliliter||Standard Deviation|Mean
1222572|NCT00718718|Secondary|Serum Sirukumab Concentrations Through Week 38 (Part A)|Sirukumab Concentrations in serum were measured.|Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38|Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part A (excluding a site based on sponsor audit for data integrity). Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure whereas 'n' signifies participants evaluable at specific time points, for each arm, respectively.|||Microgram per milliliter||Standard Deviation|Mean
1222573|NCT00718718|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)|An ACR 50 response is defined as >= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant’s assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.|Week 12|Population analyzed included all randomized participants in Part A (excluding a site based on sponsor audit for data integrity). Here 'N'(number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1222574|NCT00718718|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.|Baseline, Week 12|Population analyzed included randomized subjects in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.|||Units on a Scale||Standard Deviation|Mean
1222575|NCT00718718|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)|An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: participant’s assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant’s assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and serum C-reactive protein (CRP).|Week 12|Population analyzed included all randomized participants in Part B.|||Percentage of Participants|||Number
1222639|NCT00718315|Secondary|Percentage of Participants With Erythema Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
1222576|NCT00718666|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
1222577|NCT00718666|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
1222578|NCT00718666|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
1222579|NCT00718666|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal. Any was defined as occurrence of the symptom regardless of their intensity grade or relationship to study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.|||Participants|||Count of Participants
1222580|NCT00718666|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.|||Participants|||Count of Participants
1222581|NCT00718666|Secondary|Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers|"Vaccine response was defined as:~for initially seronegative subjects: antibody titer ≥ 1:32 at post-vaccination; and for initially seropositive subjects: antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. Titers were determined by Public Health England (PHE) laboratory assay."|At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
1222582|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, determined by Public Health England [PHE] laboratory assay.|At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Titers||95% Confidence Interval|Geometric Mean
1222583|NCT00718666|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values|The cut-off values for the assay were ≥1:8 and ≥1:128. Titers were determined by Public Health England (PHE) laboratory assay.|At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
1222584|NCT00718666|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Vaccine response was defines as: for initially seronegative subjects (pre-vaccination titer < 1:4): hSBA post-vaccination antibody titers ≥ 1:8 and for seropositive subjects (pre-vaccination titers ≥ 1:4): hSBA antibody titers at least four times the pre-vaccination antibody titers.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
1222640|NCT00718315|Secondary|Percentage of Participants With Pain|Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
1222641|NCT00718315|Secondary|Percentage of Participants With Pruritus|Pruritus is defined as intense localized itching|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
1222585|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers|Titers were given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC,hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Titers||95% Confidence Interval|Geometric Mean
1222586|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:4 or 1:8.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all vaccinated subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix1 and Nimenrix 2 Group)|||Participants|||Count of Participants
1222587|NCT00718666|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Titers||95% Confidence Interval|Geometric Mean
1222588|NCT00718666|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 or 1:128. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Participants|||Count of Participants
1222589|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Titers||95% Confidence Interval|Geometric Mean
1222590|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:4 or 1:8. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Participants|||Count of Participants
1222591|NCT00718666|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values|The cut-off values for the assay were ≥ 0.3 μg/ml and ≥ 2.0 μg/ml respectively.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222592|NCT00718666|Secondary|Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations|Results were tabulated as geometric mean antibody concentration (GMC) calculated on all subjects, expressed in microgram per milliliter (μg/ml).|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||μg/ml||95% Confidence Interval|Geometric Mean
1222593|NCT00718666|Secondary|rSBA Antibody Titers.|Titers are given as geometric mean titers (GMTs), calculated for all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 5 (60 months following primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1222594|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs), calculated on all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively by GSK Biologicals’ laboratory assay.|At Year 5 (60 months post-primary vacccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1222642|NCT00718315|Secondary|Percentage of Participants With Erythema|Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
1222595|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 3 (36 months following primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1222596|NCT00718666|Secondary|rSBA Antibody Titers.|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals’ laboratory assay.|At Year 3 (36 months post-primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1222597|NCT00718666|Secondary|rSBA Antibody Titers|Titers were given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals’ laboratory assay.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1222598|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128 determined by Public Health England (PHE) laboratory assay.|At Year 5 (60 months post-primary vacccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222599|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 5 (60 months post-primary vacccination).|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222600|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222601|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222602|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222603|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
1222604|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
1222605|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
1222606|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222607|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222608|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 1 (12 months post vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222609|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222610|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.|At Year 3 (36 months post primnary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222611|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1222612|NCT00718640|Secondary|Renal Function|Renal function was analysed by creatinine clearance. Creatinine clearance was calculated by Cockroft-Gault fourmula. Creatinine clearance is equal to 140 minus age multiplied by weight and constant (1 for men and 0.85 for women) divided by creatinine in (micro mole per liter)|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222613|NCT00718640|Secondary|Quality of Life Assessed by Euro Quality of Life (EQ-5D)|The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression where 1=better health state (no problems), 3=worst health state. Scoring formula was developed by Euro quality of life group which assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Quality of Life (EQ-5D) Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222614|NCT00718640|Secondary|Quality of Life Assessment by QLQ C-30|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale is equal to higher level of symptomatology or problems.|Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222615|NCT00718640|Secondary|Karnofsky Performance Status (KPS) Score|The KPS is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. KPS score is 11-level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222616|NCT00718640|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory (able to walk) and able to carry out work on a light or sedentary nature.|Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222617|NCT00718640|Secondary|Duration of Response|The duration of Response was defined as the time of first recorded achievement of a particular response level, which was defined according to IMWG uniform response criteria, as either complete response, stringent complete response, very good partial response or partial response included only responding participants, until the participants were assessed to have progressive disease.|Day 1 (Start of treatment) until the date of first documented achievement of response|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222618|NCT00718640|Secondary|Time to Progression (TTP) of Disease|The TTP was defined as the time from the date of starting treatment until the date of first documented evidence of progression of disease or death.|Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222619|NCT00718640|Secondary|Best Response to Treatment|It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or > reduction in serum and urine M-protein level<100 mg per 24 hour. Partial Response as <=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by <=90% or to <200mg per 24 hr.|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222620|NCT00718640|Primary|Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria|The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or >reduction in serum and urine M-protein level <100 milligram(mg) per 24 hour(hr).PR as <=50% reduction of serum and <= 90% of urine M-protein or up to <200 mg/24 hr.|Week 24 or Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1222621|NCT00718549|Secondary|Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 129|MRD: the presence of tumor cells in bone marrow, using 4-color flow cytometry of CD19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR (>/=2 months after last treatment): no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and MRD after study treatment.|12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
1222622|NCT00718549|Secondary|Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 29|MRD: the presence of tumor cells in bone marrow, using 4-color flow cytometry of CD19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR (>/=2 months after last treatment): no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and MRD after study treatment.|8 weeks after the last dose of rituximab during induction treatment (Week 29)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
1222635|NCT00718510|Primary|Change From Baseline in Mean Positive and Negative Syndrome Scale (PANSS) Total and Positive, Negative and General Psychopathology Subscale Scores at 3 Weeks|The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS) total score and PANSS positive, negative and general psychopathology subscale scores. The PANSS is a 30-item scale used to evaluate the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranges from 30 to 210 with a higher score indicating a greater severity of symptoms. The PANSS positive symptom subscale score (7 items) ranges from 7=absent to 49=extreme; the PANSS negative subscale score (7 items) ranges from 7=absent to 49=extreme; and the PANSS general psychopathology subscare score (16 items) ranges from 16=absent to 112=extreme.|Baseline and 3 Weeks|All participants who received all doses of each intervention and completed all study visits were included in the efficacy analysis|||units on a scale||Standard Deviation|Mean
1222623|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 129|CR was achieved if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed the relationship between clinical markers and clinical outcome (response) after study treatment.|12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
1222624|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 29|CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed the relationship between clinical markers and clinical outcome (response) after study treatment.|8 weeks after the last dose of rituximab during induction treatment (Week 29)|ITT population. Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among Participants included in Overall IIT population only.|||percentage of participants|||Number
1222625|NCT00718549|Secondary|PFS Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors|PFS: time from date of randomization to date of PD, relapse, or death from any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD: appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of >/=50% in greatest determined diameter of any previous site; an increase in previously noted enlargement of liver or spleen by >/=50%; an increase in number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000/mcL; transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and clinical outcome (PFS) after study treatment.|From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||years||95% Confidence Interval|Median
1222626|NCT00718549|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR|MRD was defined by the presence of tumor cells in bone marrow, using 4-color flow cytometry of cluster of differentiation (CD)19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR: if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline).|8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||percentage of participants||95% Confidence Interval|Number
1222627|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL|CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, platelets (PL) >100,000/mcL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), bone marrow (BM) sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly (decrease in lymph node size by >/=50% compared to pre-treatment state, no increase in any lymph node, no new enlarged lymph node); a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline).|8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||percentage of participants||95% Confidence Interval|Number
1222636|NCT00718328|Primary|Perihematomal Edema|Solitary patient lost to follow up (out of state)|Days 7 and 14||||Relative perihematomal edema||Standard Deviation|Mean
1222628|NCT00718549|Primary|Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL|PFS was defined as the time from date of randomization to date of PD, relapse, or death due to any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of >/=50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by >/=50%; an increase in the number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000/mcL; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.|From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||years||95% Confidence Interval|Median
1222629|NCT00718549|Primary|Percentage of Participants With Disease Progression (PD), Relapse, or Death Due to Any Cause Assessed According to the National Cancer Institute (NCI) Revised Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia (CLL)|PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (greater than [>]1.5 centimeters [cm]), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of greater than or equal to (>/=) 50 percent (%) in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by >/=50%; an increase in the number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000 per microliter (/mcL); transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.|From randomization to PD, Relapse, or death due to any cause (overall approximately 5 years)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-treatment efficacy measurement available. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1222630|NCT00718523|Secondary|Overall Survival (OS)|Interval between the date from randomization to death from any cause whichever came first.|Day 1 of each cycle up to 4 years after randomization|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
1222631|NCT00718523|Secondary|Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
1222632|NCT00718523|Primary|Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
1222633|NCT00718510|Secondary|Change From Baseline in Mean Calgary Depression Scale for Schizophrenia (CDSS) at 3 Weeks|The Secondary Outcome Measure was the Calgary Depression Scale for Schizophenia (CDSS). The CDSS is a 9-item scale that is used to rate the depressive symptoms in patients with schizophrenia. For each CDSS item, symptom severity was rated on a 3-point scale, from 0=absent to 3=severe. The CDSS total score ranges from 0 to 27 with a higher score indicating a greater severity of symptoms.|Baseline and 3 Weeks||||units on a scale||Standard Deviation|Mean
1222634|NCT00718510|Secondary|Change From Baseline in Mean Clinical Global Impression (CGI) Scale at 3 Weeks|The Secondary Outcome Measure was the Clinical Global Impression (CGI) scale. The CGI is a 3-item scale that rates treatment response and monitors the clinical course of all psychiatric illnesses including schizophrenia. Within the CGI, the Severity of Illness was rated on a 7-point scale, 0=not assessed to 7=among the most severely ill patients. For Global Improvement, the total improvement following treatment as compared to at baseline of the trial was rated on a 7-point scale, 0=not assessed to 7=very much worse.|Baseline and 3 Weeks|All participants who received all doses of each intervention and completed all study visits were included in the efficacy analysis|||units on a scale||Standard Deviation|Mean
1222637|NCT00718315|Secondary|Percentage of Participants With Pain Stratified by Severity Grade|The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
1222638|NCT00718315|Secondary|Percentage of Participants With Pruritus Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
1223634|NCT00711009|Secondary|Mean Change From Baseline in Monocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1222645|NCT00718315|Primary|Percentage of Participants Who Develop Skin Rash|Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line “Rash/desquamation” – short name “rash”).|30 Days|ITT Population|||percentage of participants||95% Confidence Interval|Number
1222646|NCT00718302|Secondary|SMFA - Bother Index|The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
1222647|NCT00718302|Secondary|The Short Musculoskeletal Functional Assessment (SMFA) Score|The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.|3 months, 6 months, 9 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
1222648|NCT00718302|Secondary|American Orthopedic Foot and Ankle Society Score (AOFAS) Scores|American Orthopedic Foot and Ankle Society Score (AOFAS) score. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. A subject can score anywhere from 0-100, 100 being best.|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
1222649|NCT00718302|Secondary|Percentage Normal Peroneal Tendons|Percentage of Participants with Normal Peroneal Tendons|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||percentage of participants|||Number
1222650|NCT00718302|Primary|Percentage of Nonpalpable Hardware|Percentage of Participants with Nonpalpable Hardware|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP)|||percentage of participants|||Number
1222651|NCT00718237|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool antigen prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
1222652|NCT00718237|Primary|Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
1222653|NCT00718237|Secondary|Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
1222654|NCT00718159|Secondary|Pharmacokinetics: Concentration Maximum (Cmax) of LY573636||Predose up to 24 hours postdose in Cycle 1|Participants who received the study drug and had pharmacokinetic (PK) data.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1222655|NCT00718159|Secondary|Number of Participants With Bone Marrow (BM) Response|The International Working Group's revised recommendations were used to assess response in acute myeloid leukemia (AML): complete response (CR) is <5% blasts in BM and with a cell count ≥200 cells in BM, and with peripheral blood platelets ≥100x10⁹/liter (L) and absolute neutrophils ≥1x10⁹/L; CR with incomplete blood count recovery is defined as CRi; partial response (PR) is ≥5% blasts in BM but with ≥50% reduction in blast count. Number of responders for AML = CR+PR+ CRi. Result of a European Leukemia Net consensus conference was used to assess response in essential thrombocythemia (ET). CR is platelets ≤400x10⁹/L in peripheral blood, no disease-related symptoms, normal spleen size and white blood cells ≤10x10⁹/L in peripheral blood; PR has platelets ≤600x10⁹/L in peripheral blood or decrease > 50% from baseline but does not meet CR criteria. Number of responders for ET = CR+PR.|Baseline to measured progressive disease up to 70 days|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
1222656|NCT00718159|Secondary|Pharmacokinetics Area Under the Curve(AUC) of LY573636 Above the Albumin-Corrected Threshold (AUCalb)|LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.|Days 1-35 of Cycle 1|Participants who received the study drug and had pharmacokinetic (PK) data.|||micrograms*hour/milliliter (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1222657|NCT00718159|Primary|Recommended Phase 2 Dose of LY573636-Sodium in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Essential Thrombocythemia (ET)|Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose at which no more than 1 of 6 participants experienced a dose-limiting toxicity (DLT) and level immediately below that which had ≥2 instances of DLT. A DLT is an adverse event (AE) observed during the first cycle of treatment that is believed to be related to LY573636 and fulfills any of the following: ET only , Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity for ≥3 days; For all, ≥Gr 3 nonhematological toxicity except for nausea/vomiting or diarrhea unless it fits the next criteria; ≥Gr 3 nausea, vomiting, or diarrhea that persists >7 days despite maximal treatment; Gr 3 electrolyte disturbances that persist despite maximal measures; DLT can be declared if a participant experienced increasing toxicity during treatment. The primary outcome measure was not analyzed because the enrollment was stopped early before MTD was reached.|Predose up to 35 days postdose in Cycle 1|No participants were analyzed since the MTD was not reached.||||||
1222658|NCT00718120|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1222659|NCT00718120|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1222660|NCT00718120|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.|During the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
1222661|NCT00718120|Primary|Fold Increase From Baseline in Serum HI Antibody Titer|The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.|At Day 21||||fold increase|||Number
1222662|NCT00718120|Primary|Number of Seroprotected Subjects|Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.|At Day 0 and 21||||subjects|||Number
1222663|NCT00718120|Primary|Number of Seroconverted Subjects|Seroconversion, defined as a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.|At Day 21||||subjects|||Number
1222664|NCT00718120|Primary|Hemagglutination Inhibition (HI) Antibody Titers|Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.|At Day 0 and 21||||titer||95% Confidence Interval|Geometric Mean
1222665|NCT00718094|Primary|Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.|"This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity.~Each variable is scored from 0–3 so that the total index score ranges from 0–12; 0–2: remission; 3–6: mild; 7–10: moderate; >10: severe UC."|day 56||||Participants|||Count of Participants
1222666|NCT00718081|Secondary|Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief|At the end of the 12-hour study period each patient rated their overall pain relief since starting study drug on a 5-point scale: poor, fair, good, very good or excellent.|Up to 12 hours after surgery||||percentage of patients|||Number
1222667|NCT00718081|Primary|SPID-12|The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.|12 hours after surgery||||units on a scale||Standard Error|Least Squares Mean
1222668|NCT00718042|Secondary|ESA Chagas Testing in Chagas Endemic Population|Specimen collected in Chagas endemic areas in South or Central America (524) tested with ESA Chagas and licensed test for T cruzi antibody. Specimens repeatedly reactive with either screening assay and/or ESA Chagas positive were tested with supplemental assay (RIPA). Presentation of ESA Chagas results for 132 specimens from a Chagas endemic population that were RIPA positive.|2 months|Total of 132 out of the 524 specimens from Chagas endemic areas that were tested RIPA positive per protocol.|||participants|||Number
1222669|NCT00718042|Secondary|ESA Chagas Sensitivity in Serologically Positive Non-US Specimens|ESA Chagas Sensitivity in a non-US population was determined for the 85 out of the total 287 serologically positive specimens (202 US Serology Positive specimens were excluded). These specimens were collected from individuals positive for T cruzi antibodies based on 2 different serologic tests for antibodies to T cruzi in Argentina and were tested with ESA Chagas.|3 months|A total of 85 serum specimens from non-US individuals reactive for T cruzi antibodies per protocol.|||participants|||Number
1222670|NCT00718042|Primary|ESA Chagas Sensitivity|Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.|3 months|Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol.|||participants|||Number
1222671|NCT00718042|Primary|ESA Chagas Specificity|Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.|3 months|Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol.|||participants|||Number
1222672|NCT00718042|Secondary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.|A total of 41,760 US blood donor specimens were tested by ABBOTT PRISM Chagas. Of these specimens, 58 out of 79 specimens were T cruzi antibody repeatedly reactive by ABBOTT PRISM Chagas (26 from 16,249 donor specimens tested in design validation phase and 32 from 25,511 specimens from the Chagas extended evaluation). Donor specimens that were repeatedly reactive with the licensed T cruzi antibody assay, but PRISM Chagas nonreactive (6) and specimens PRISM Chagas grayzone negative (15) were excluded from this analysis.|15 months|A total of 58 US blood donor specimens were PRISM Chagas repeatedly reactive were included per protocol.|||participants|||Number
1222673|NCT00718042|Secondary|PRISM Chagas Reactivity in Chagas Endemic Population|Population of specimen collected in Chagas endemic area in South/Central America (524) were tested to demonstrate reactivity with the PRISM Chagas assay in a population with a 5% or greater prevalence of infection with T cruzi antibody. specimens tested with PRISM Chagas assay and licensed test for T cruzi antibody and if repeatedly reactive with either assay the specimens were tested with supplemental assay (RIPA). Data presented with PRISM Chagas and RIPA results.|2 months|Total of 524 specimens from Chagas endemic areas tested with PRISM Chagas per protocol.|||participants|||Number
1222674|NCT00718042|Primary|PRISM Chagas Sensitivity|Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.|6 months|Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol.|||participants|||Number
1222675|NCT00718042|Secondary|PRISM Chagas Reactivity Serology Positive Specimens|Total of 85 specimens from subjects from South America known to be positive for T cruzi antibodies and 202 US blood donor specimens that were repeatedly reactive on a licensed test for antibodies to T cruzi were tested with the PRISM Chagas assay and supplemental testing (RIPA).|4 months|Total of 287 specimens presumed T cruzi antibody positive per protocol.|||participants|||Number
1222676|NCT00718042|Primary|PRISM Chagas Specificity|Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay [radioimmune precipitation assay (RIPA)].|6 months|All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol.|||participants|||Number
1222677|NCT00717977|Primary|Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1222678|NCT00717977|Primary|Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1222679|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Time of Day|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||Percent||Inter-Quartile Range|Median
1222680|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Age Group|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||Percent||Inter-Quartile Range|Median
1222681|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Time of Day||48-72 hours||||mg/dL/min||Inter-Quartile Range|Median
1222682|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Age Group||48-72 hours||||mg/dL/min||Inter-Quartile Range|Median
1222683|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Time of Day|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1222684|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Age Group|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1222685|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels >140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.~Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels >140 mg/dl' for all 24 hours."|48-72 hours||||Percent||Inter-Quartile Range|Median
1222686|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
1222687|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
1222688|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
1222689|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels <=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.~Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels <=60mg/dL' for all 24 hours."|48-72 hours||||Percent||Inter-Quartile Range|Median
1222690|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
1222691|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
1222692|NCT00717977|Primary|Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
1222693|NCT00717977|Primary|Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
1223635|NCT00711009|Secondary|Mean Change From Baseline in Lymphocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1222694|NCT00717977|Primary|Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group|The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.|48-72 hours||||Percent||Inter-Quartile Range|Median
1222695|NCT00717977|Primary|Nighttime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1222696|NCT00717977|Primary|Daytime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1222697|NCT00717977|Primary|Peak Nightime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1222698|NCT00717977|Primary|Peak Daytime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1222699|NCT00717977|Primary|Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.|48-72 hours||||mg/dL||Standard Deviation|Mean
1222700|NCT00717977|Primary|Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.|48-72 hours||||mg/dL||Standard Deviation|Mean
1222701|NCT00717977|Primary|Overall Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.|48-72 hours||||mg/dL||Standard Deviation|Mean
1222702|NCT00717912|Secondary|Insulinemic Index|"The specific measure that will be use to determine the insulinemic responses is the change in blood insuline levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.~Sugar syrup was used as the reference food, giving it a insulinemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above"|Every 48 hours (each new intervention), over a 2 hour blood glucose challenge||||% of the GI of the glucose||Standard Deviation|Mean
1222703|NCT00717912|Primary|Glycemic Index|"The specific measure that will be use to determine the glycemic responses is the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.~Sugar syrup was used as the reference food, giving it a glycemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above"|Every 48 hours (each new intervention), over a 2 hour blood glucose challenge||||% of GI of the glucose||Standard Deviation|Mean
1222704|NCT00717886|Primary|Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).||2 years||||participants|||Number
1222705|NCT00717873|Primary|Hospital Length of Stay|an average of 10 days|Admission to Discharge||||days||Standard Deviation|Mean
1222706|NCT00717860|Secondary|Number of Participants With Favorable Overall Response at the End of Study Therapy|Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|Per Protocol Set (PPS) population.|||Participants|||Number
1222707|NCT00717860|Secondary|Number of Participants With a Specific Safety Finding|A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|APaT population.|||Participants|||Number
1222708|NCT00717860|Primary|Number of Participants With a Significant Drug-related Adverse Experience|A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|All Participants as Treated (APaT) population.|||Participants|||Number
1222709|NCT00717756|Primary|Response Rate by Recist Criteria|"radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD~It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed."|on average about every 2 months until progression, on average about 4 months.||||participants|||Number
1222710|NCT00717574|Primary|The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)|"We planned this study to compare the effect of adding N2O on BIS and SE during an intravenous or an inhalation anesthetic. We hypothesized that neither BIS nor SE would decrease in response to the addition of N2O to a Propofol anesthetic. We also hypothesized that neither BIS nor SE would decrease in participants under Sevoflurane anesthesia if the inspired concentration of Sevoflurane were carefully and continuously adjusted to maintain a constant end-tidal concentration during the addition and discontinuation of N2O.~BIS (0-100) and SE (0-92) are unitless, ordinal indices of anesthetic depth. Both indices are decreased when the depth of anesthesia is increased."|From baseline to 20 minutes after the addition of 60% nitrous oxide||||units on a scale||Standard Deviation|Mean
1222724|NCT00717405|Secondary|Number of Participants Who Underwent Mastectomy|Surgery included a mastectomy with axillary node dissection and had to be performed at least 4 weeks after the last infusion of neoadjuvant bevacizumab treatment.|Anytime between Week 26 and Week 29|ITT population.|||participants|||Number
1222796|NCT00717093|Secondary|Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use|Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL.|Week 9 through 12, Week 26|ITT|||participants|||Number
1222711|NCT00717522|Secondary|Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines|Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).|This analysis was not done. Study enrollment was suspended due to a corporate strategic decision unrelated to patient safety, and the protocol was amended to evaluate safety only (efficacy data was stored but not cleaned or analyzed unless related to safety).||||||
1222712|NCT00717522|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs|An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject’s health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.|AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).|All participants|||participants|||Number
1222713|NCT00717418|Other Pre-specified|Schirmer's Test With and Without Anesthesia at Baseline|Schirmer’s Test with and without anesthesia at baseline. The Schirmer’s test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit).|||millimeters (mm)||Standard Deviation|Mean
1222714|NCT00717418|Primary|Ocular Surface Disease Index (OSDI) Total Score at Baseline|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.|||Scores on a Scale||Standard Deviation|Mean
1222715|NCT00717405|Secondary|Overall Survival (OS) Duration|OS was defined as the time from the first administration of neoadjuvant treatment to death of any cause. OS was estimated using Kaplan-Meier method.|Up to 5 years|ITT population.|||months||95% Confidence Interval|Median
1222716|NCT00717405|Secondary|Percentage of Participants Who Were Alive at 3 and 5 Years||3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
1222717|NCT00717405|Secondary|Recurrence Free Survival (RFS) Duration|RFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.|||months||95% Confidence Interval|Median
1222718|NCT00717405|Secondary|Percentage of Participants Who Were Recurrence Free at 3 and 5 Years|A participant was considered recurrence free if the participant did not experience local or regional recurrence (wall or axillaries nodes), or occurrence of distant metastases (including soft tissue and distal lymph nodes).|3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
1222719|NCT00717405|Secondary|Disease Free Survival (DFS) Duration|DFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.|||months||95% Confidence Interval|Median
1222720|NCT00717405|Secondary|Percentage of Participants Who Were Disease Free at 3 and 5 Years|A participant was considered disease free if the participant did not experience any of the following events: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colon carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause.|3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
1222721|NCT00717405|Secondary|Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit||Baseline, Neoadjuvant Final Visit (Week 25)|Safety population: Number of participants included all the participants who received at least one infusion of bevacizumab. n included participants who were evaluable at that time point.|||Units per milliliter (U/mL)||Standard Deviation|Mean
1222722|NCT00717405|Secondary|Percentage of Participants Who Underwent Lymph Node Resection|Among the participants who were planned to undergo mastectomy, lymph node resection was also performed by the physician depending up on the participant's breast cancer grades.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.|||percentage of participants|||Number
1222723|NCT00717405|Secondary|Percentage of Participants With Macroscopically Visible Tumor|Local pathologists assessed the tumor whether it was macroscopically visible or not and percentage of participants for whom the tumor was macroscopically visible was reported.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.|||percentage of participants|||Number
1222725|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on overall clinical response at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed. n included number of participants who were evaluable at a particular time point.|||percentage of participants|||Number
1222726|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on inflammatory signs at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed and were evaluated for response from baseline assessment of inflammatory signs. n included number of participants who were evaluable at a particular time point.|||percentage of participants|||Number
1222727|NCT00717405|Secondary|Percentage of Participants With a PCR According to the Chevallier Classification|PCR was assessed at the time of definitive surgery according to Chevallier classification and centrally reviewed by an independent committee under blinded conditions. The Chevallier classification for grading of therapeutic effect related to the primary tumor site and axillary lymph nodes was defined by microscopic changes as follows - Grade 1: Disappearance of all tumors either in the breast or in the nodes, Grade 2: Persistence of carcinoma in situ in the breast only and no nodal invasion, Grade 3: Presence of invasive carcinoma with stromal alteration, Grade 4: Presence of invasive carcinoma without modification. Grade 1 response was considered as PCR. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1222728|NCT00717405|Primary|Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification|PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1222729|NCT00717366|Secondary|Apparent Terminal Phase Half-Life (t1/2) of MIRCERA|t1/2 was defined as the time (in hours) measured (from all sample collection timepoints [as provided in timeframe]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population. Number of participants analyzed = participants evaluable for t1/2 assessments.|||hours||Geometric Coefficient of Variation|Geometric Mean
1222730|NCT00717366|Secondary|Time to Reach Cmax (Tmax) of MIRCERA|Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints [as provided in timeframe]). The median time, among all participants, was reported.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population.|||hours||Full Range|Median
1222731|NCT00717366|Secondary|Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA|Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population. Number of participants analyzed = participants with AUC0-672h assessment at specified time-points.|||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1222732|NCT00717366|Secondary|Maximum Observed Serum Concentration (Cmax) of MIRCERA|Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|Pharmacokinetic (PK) evaluable population included all enrolled participants who received at least one dose of study drug and had evaluable PK assessment. Here 'n' signifies number of participants evaluable at specified time-points.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1222733|NCT00717366|Secondary|Change in Average Reticulocyte Count Between the Baseline and Evaluation Period|A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.|Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|ITT population. Reticulocyte values within 21 days after blood transfusion(s) were excluded from analysis. Here, number of participants analyzed = participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time-points.|||10^3 cells/microliter||Standard Deviation|Mean
1222734|NCT00717366|Secondary|Number of Participants With Blood Transfusions||Baseline to Week 20|ITT population.|||participants|||Number
1222735|NCT00717366|Secondary|Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL|The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).|Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.|||participants|||Number
1222736|NCT00717366|Secondary|Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb|Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).|Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.|||participants|||Number
1222737|NCT00717366|Primary|Change in Average Hb Concentration Between Baseline and Evaluation Period|A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.|Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis.|||g/dL||Standard Deviation|Mean
1222738|NCT00717314|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52|The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.|Week 52|PP population|||percentage of participants|||Number
1222739|NCT00717314|Secondary|Percentage Change in Creatinine Clearance From Baseline|Creatinine clearance was calculated using the Cockcroft and Gault formula.|Weeks 16, 28, 40, and 52|PP population|||percentage change from baseline||Standard Deviation|Mean
1222740|NCT00717314|Secondary|Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52|Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Week 52|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.|||mL/min||95% Confidence Interval|Mean
1222741|NCT00717314|Secondary|Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])|Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Baseline and Weeks 16, 28, and 40|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
1222742|NCT00717314|Secondary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52|BPAR was graded according to Banff criteria.|Week 52|PP population|||percentage of participants|||Number
1222743|NCT00717314|Secondary|Percentage of Participants With Graft Loss or Death at Week 52|Graft loss was defined for this protocol as re-transplantion or death.|Week 52|PP population|||percentage of participants|||Number
1222744|NCT00717314|Primary|Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%|The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.|Week 52|PP population|||percentage of participants|||Number
1222745|NCT00717288|Secondary|Reversion to Intravenous Insulin for Failure of Glycemic Control|Number of participants who went back on intravenous insulin for failure of glycemic control.|72 hours||||participants|||Number
1222746|NCT00717288|Secondary|Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)|Number of patients with hypoglycemia (defined as glucose <65 mg/dl)|48 hours|Intention to treat (ITT)|||participants|||Number
1222747|NCT00717288|Primary|Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3|Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3|day 2, day 3|intention to treat (ITT)|||participants|||Number
1222748|NCT00717275|Primary|Number of Participants Who Developed Distant Brain Failure at One Year.||1 Year|Data was not analyzed.||||||
1222749|NCT00717249|Primary|Average Contact Lens Wear Time|The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.|6 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||time in hours||Full Range|Mean
1222750|NCT00717249|Primary|Visual Acuity|Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
1222751|NCT00717249|Primary|Subject Reported Symptoms|"Subjects were asked Have you experienced any symptoms or problems since your last visit? at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, Dryness, Other, Cloudy/ Blurry / Hazy, Irritation / Discomfort. The percentage of each response across all visits was reported."|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Percentage of Observations|Participants||Number
1246046|NCT00537823|Primary|Postoperative Complication Rate|Fraction of patients with any grade of complication I-V|30 days following surgery|4 participants did not have surgery.|||percentage of participants|||Number
1222752|NCT00717249|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Number of Subject Eyes|Participants||Number
1222753|NCT00717236|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 848 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
1222754|NCT00717236|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 857 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
1222755|NCT00717236|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 856 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
1222756|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 28|Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 851 had observed values at Week 28 and Baseline and are included in this analysis|||mg/L||95% Confidence Interval|Least Squares Mean
1222757|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 854 had observed values at Week 28 and Baseline and are included in this analysis|||units on a scale||Standard Error|Least Squares Mean
1222758|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 28|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1222759|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 28|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1222760|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1222761|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1222762|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1222773|NCT00717236|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
1222763|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1222764|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 828 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1222765|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1222766|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 28|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1222767|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 28|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1222768|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 28|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1222769|NCT00717236|Secondary|European League Against Rheumatism (EULAR) Response at Week 12|EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)].|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1222770|NCT00717236|Secondary|Time to Sustained American College of Rheumatology 20% (ACR20) Response|The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12).|Baseline up to Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1222771|NCT00717236|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (827 CZP, 202 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
1222772|NCT00717236|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
1222774|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 12|Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1046 (841 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1222775|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (826 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1222776|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1222777|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1222778|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1222779|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1222780|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1222781|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis.|||units on a scale||Standard Deviation|Mean
1222782|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1222783|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1037(834 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1222784|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 12.|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1222795|NCT00717093|Secondary|Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco|Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26.|Week 26|ITT|||participants|||Number
1246047|NCT00537810|Primary|BMI||4 months treatment|Participants with complete data reported here (i.e., no imputation)|||BMI (kg/m^2)||Standard Deviation|Mean
1222785|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 12|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1222786|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 807 were in the disease duration greater than or equal to 2 years stratum (645 CZP, 162 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1222787|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 256 were in the disease duration less than 2 years stratum (206 CZP, 50 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1222788|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 663 were in the no prior anti-tumor necrosis (anti-TNF) use stratum (531 CZP, 132 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1222789|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 400 were in the prior anti-tumor necrosis (anti-TNF) use stratum (320 CZP, 80 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1222790|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 331 were in the no concomitant methotrexate use stratum (262 CZP, 69 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1222791|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 732 were in the concomitant methotrexate use stratum (589 CZP, 143 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1222792|NCT00717236|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects (851 CZP, 212 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of subjects|||Number
1222793|NCT00717197|Primary|Percentage of Participants With Progression-free Survival.|Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.|From date of first dose of study drug until month 6.|Per protocol|||percentage of participants with PFS6||95% Confidence Interval|Number
1222794|NCT00717093|Secondary|Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)|Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL.|Week 12, Week 26|ITT|||participants|||Number
1222797|NCT00717093|Primary|Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco|"Number of subjects who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL."|Weeks 9 through 12|Intent to treat (ITT)|||participants|||Number
1222798|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals|Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to <480 msec, 480 to <500 msec, and >500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to < 60 msec, and change = ≥ 60 msec.|Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.|||subjects|||Number
1222799|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute|Number of subjects with pulse rate < 40 beats per minute (BPM), number of subjects with pulse rate > 120 BPM.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.|||bpm|||Number
1222800|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure|Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: <90 mmHg; and supine diastolic blood pressure, range: <50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication. BL: Baseline.|||subjects|||Number
1222801|NCT00717067|Secondary|Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD|CLdD: dialysate clearance before dialysis; measured in milliliters per minute.|Before dialysis|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mL/min||Standard Deviation|Geometric Mean
1222802|NCT00717067|Secondary|Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae|Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mg||Standard Deviation|Mean
1222803|NCT00717067|Secondary|Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function|Renal clearance (CLR) measured in milliliters per minute (mL/min).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mL/min||Standard Deviation|Geometric Mean
1222804|NCT00717067|Secondary|Half-life (t1/2)|Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||hour||Standard Deviation|Mean
1222805|NCT00717067|Secondary|Time of First Occurrence (Tmax)|Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||hours||Full Range|Median
1222806|NCT00717067|Secondary|Area Under the Time Curve From 0 to Infinity (AUCinf)|Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms * hour divided by millilters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUC infinity was not determined for subjects in the multiple dose treatment groups.|||ng*hr/mL||Standard Deviation|Geometric Mean
1222807|NCT00717067|Secondary|Plasma Protein Binding|Percent protein binding (protein unbound maraviroc (MVC) fraction [percent free]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.|2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||percent free|||Number
1222808|NCT00717067|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||ng/mL||Standard Deviation|Geometric Mean
1222809|NCT00717067|Primary|AUCtau|AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms * hours divided by milliliters (ng.hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUCtau for end stage renal disease subjects was not determined.|||ng*hr/mL||Standard Deviation|Geometric Mean
1246048|NCT00537810|Primary|Binge Eating (Remission)|Remission from binge eating (zero binge episodes during previous 28 days)|4 months treatment; 6 and 12 month follow up post treatment||||participants|||Number
1222810|NCT00717067|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms * hour divided by milliliters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||ng*hr/mL||Standard Deviation|Geometric Mean
1222811|NCT00717054|Secondary|Need for Antiemetic Medication||24 hours postoperatively||||participants|||Number
1222812|NCT00717054|Secondary|Total Vomiting||24 hours postoperatively||||participants|||Number
1222813|NCT00717054|Secondary|Number of Participants With Nausea and Vomiting in PACU||Postoperatively, up to 2 hours||||participants|||Number
1222814|NCT00717054|Primary|Number of Participants With Nausea and Vomiting||24 hours postoperatively||||participants|||Number
1222815|NCT00717041|Secondary|Depression and Cognitive Impairment at 2 Weeks|For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.|2 weeks||||participants||95% Confidence Interval|Number
1222816|NCT00717041|Primary|Participants With Anxiety by Generalized Anxiety Disorder - 7|Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.|2 hours||||participants|||Number
1222817|NCT00717041|Primary|Participants With Cognitive Impairment by Six Item Screener|Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect|2 hours||||participants|||Number
1222818|NCT00717041|Primary|Participants With Depression by Patient Health Questionnaire - 9|Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.|2 hours||||participants|||Number
1222819|NCT00716976|Secondary|Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)||4 weeks after the last dose of cisplatin|Data was and never will be collected||||||
1222820|NCT00716976|Secondary|Overall Survival (OS)|Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description.|4 Years after enrollment|61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm.|||Percentage probability||95% Confidence Interval|Number
1222821|NCT00716976|Secondary|Event-Free Survival (EFS)|Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description.|4 years after enrollment|61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm.|||Percentage probability||95% Confidence Interval|Number
1222822|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 8000 hz|Mean change in hearing threshold (post-pre) at 8000 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 8000 hz; 42 patients in the observation arm had paired audiometry at 8000 hz.|||Decibels||Standard Deviation|Mean
1222823|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 4000 hz|Mean change in hearing threshold (post-pre) at 4000 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 4000 hz; 47 patients in the observation arm had paired audiometry at 4000 hz.|||Decibels||Standard Deviation|Mean
1222824|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 2000 hz|Mean change in hearing threshold (post-pre) at 2000 hz|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 2000 hz; 47 patients in the observation arm had paired audiometry at 2000 hz.|||Decibels||Standard Deviation|Mean
1222825|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 1000 hz|Mean change in hearing threshold (post-pre) at 1000 hz.|4 weeks after last dose of cisplatin|37 eligible patients in the STS arm had paired audiometry at 1000 hz; 47 patients in the observation arm had paired audiometry at 1000 hz.|||Decibels||Standard Deviation|Mean
1222826|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 500 hz|Mean change in hearing threshold (post-pre) at 500 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 500 hz; 45 patients in the observation arm had paired audiometry at 500 hz.|||Decibels||Standard Deviation|Mean
1222827|NCT00716976|Primary|Incidence of Hearing Loss|Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.|4 weeks after last dose of cisplatin|55 eligible patients enrolled on the observation Arm had complete audiometry data for evaluation; 49 eligible patients enrolled on the STS arm had complete data audiometry for evaluation.|||Patients|||Number
1222828|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||24 hours methacholine and sputum|||||||
1222829|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||sputum @ 7 hours|||||||
1222830|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).||Before inhalation both evaluations (0 hours)|||||||
1222831|NCT00716963|Primary|The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.||7 hours after challenge|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.|||percentage fall FEV1||Standard Deviation|Mean
1222832|NCT00716963|Primary|The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.||Before inhalation 3 hours|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.|||percentage fall FEV1||Standard Deviation|Mean
1222833|NCT00716859|Secondary|Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience|An investigator’s causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as “related to investigational product” for reporting purposes.|Baseline through Week 12|Intent to treat (ITT) population: all participants who were randomized into the study and received at least 1 dose of study medication.|||Percentage of particpants|||Number
1246049|NCT00537771|Secondary|Time to Treatment Failure||Within 3 years||||days||95% Confidence Interval|Median
1222834|NCT00716859|Secondary|Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12|Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4, and Week 12|Evaluable participants in PP|||Percentage of participants||95% Confidence Interval|Number
1222835|NCT00716859|Secondary|Mean IOP at Week 12|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 12|Evaluable participants in PP|||mmHg||Standard Deviation|Mean
1222836|NCT00716859|Secondary|Mean IOP at Week 4|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 4|Evaluable participants in PP|||mmHg||Standard Deviation|Mean
1222837|NCT00716859|Secondary|Mean IOP at Week 1|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 1|PP|||mmHg||Standard Deviation|Mean
1222838|NCT00716859|Secondary|Mean IOP at Baseline|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline|PP|||mmHg||Standard Deviation|Mean
1222839|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 12 (Observed)|Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Evaluable participants in PP|||mmHg||Standard Error|Least Squares Mean
1222840|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 4|Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4|Evaluable participants in PP|||mmHg||Standard Error|Least Squares Mean
1222841|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 1|Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 1|PP|||mmHg||Standard Error|Least Squares Mean
1222842|NCT00716859|Primary|Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)|Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Per Protocol (PP) Population: participants with no major protocol violations who received at least 1 week of study medication and had at least Week 1 IOP measurements. LOCF.|||mmHg||Standard Error|Least Squares Mean
1222843|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222844|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222845|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222846|NCT00716820|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222847|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222848|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222849|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222850|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222851|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222852|NCT00716820|Secondary|Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1222853|NCT00716820|Secondary|Objective Response Rates by c-Kit Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1222854|NCT00716820|Secondary|Objective Response Rates by KIT Expression Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1222855|NCT00716820|Primary|Objective Response Rate|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1222856|NCT00716820|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222857|NCT00716807|Primary|Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.||20 minute intervals for three hours.|Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants.||||||
1222858|NCT00716742|Primary|Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year|Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).|Baseline, 1 Year|Intent-to-treat, which includes all patients who started the study and completed the one-year follow-up visit and whose data was available for this outcome measure.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1222859|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222860|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222861|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222862|NCT00716625|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222863|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222864|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222865|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222866|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222867|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222868|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Pediatric Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Pediatric population was defined as the participants who aged younger than 15, and adult population was defined as those aged 15 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222869|NCT00716625|Primary|Objective Response Rate|Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1222870|NCT00716625|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1222871|NCT00716482|Secondary|Interobserver Agreement of B Mode Ultrasound and SWE Features|614 benign and 144 malignant breast masses.|performed on the same day, after study completion|Per protocol. One lesion was analyzed per participant. Two independent readers did a qualitative assessment of 7 image parameters (per lesion) using Kappa.|||kappa statistic||95% Confidence Interval|Number
1222872|NCT00716482|Secondary|Intraobserver Reliability of Quantitative SWE Measurements|614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.|performed on the same day, within 2 years from study start date|Per protocol. 758 masses (614 benign and 144 malignant)are analyzed. One lesion was analyzed per participant. 3 acquisitions per lesion were analyzed with the ICC method for 10 different parameters.|||correlation coefficient||95% Confidence Interval|Number
1222873|NCT00716482|Secondary|Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature|614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.|performed on the same day, within 2 years from study start date|Per protocol. One lesion was analyzed per participant.|||participants|||Number
1222874|NCT00716482|Primary|Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics|"Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size.~Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions.~Based on 939 lesions."|2 years|Per protocol. Analysis includes 289 malignant and 650 benign masses. One lesion was analyzed per participant.|||participants|||Number
1222875|NCT00716456|Primary|The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks|To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)|At conclusion of study, up to 24 weeks||||mg/m2 of CETUXIMAB|||Number
1222876|NCT00716443|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds|Number of participants w/ tolerability assessments (erythema, edema, blanching) resulting in adverse events from Baseline to two days after injection of Restylane® into the nasolabial folds|Baseline to two days after injection of Restylane® into the nasolabial folds|Safety|||participants|||Number
1222877|NCT00716443|Secondary|"Number of Participants With Yes/no Answers to Question to Investigator Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure? Day of Injection of Restylane® Into Nasolabial Folds"|"Number of participants with yes or no answers to question asked to investigator on the day of injection of Restylane® into the nasolabial folds Did the topical anesthetics provided adequate anesthesia for the injections of Restylane® into the nasolabial folds procedure?"|Day of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222878|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222879|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after an injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222880|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222881|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222882|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222883|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222884|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222885|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|Upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222886|NCT00716443|Secondary|"Number of Participants Who Answered the Question Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member? 3 Hours After Injection of Restylane® Into Nasolabial Folds"|"Number of participants who answered No, Yes or No response to the question Still speaking to the topical anesthetic you had on the right/left side of your face, would you recommend it to your friend or family member? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222887|NCT00716443|Secondary|"Number of Participants Who Answered the Question If it Was Different Than What You Expected, Was it? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered the question If it was different than what you expected, was it? (More pain, Less pain or No response) three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222888|NCT00716443|Secondary|"Number of Participants Who Answered the Question If You Experienced Pain, Was it What You Expected From the Injection Procedure? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered No, Yes, Had no expectations or No response to the question If you experienced pain, was it what you expected from the injection procedure? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222889|NCT00716443|Secondary|"Number of Participants Who Answered the Question What Level of Pain Did You Experience When You Were Injected? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered according to a scale of None, Minimal, Mild, Moderate, Severe, or No response to the question What level of pain did you experience when you were injected? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1222890|NCT00716443|Primary|Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds|Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||centimeters||Standard Deviation|Mean
1222891|NCT00716417|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of afatinib in plasma at steady state|0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration|The pharmacokinetic analysis set includes all patients who took at least one dose of trial medication and provided at least one blood sample following drug administration. Values were excluded from descriptive statistics when a comparison with plasma concentrations in the same treatment group was impossible.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1223052|NCT00715741|Primary|Oxygen Requirement to Maintain SpO2>90%|Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.|45 min after emergence (tracheal extubation)||||liters per minute||Inter-Quartile Range|Median
1222892|NCT00716417|Secondary|Number of Patients With Objective Response|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR).|Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days)|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
1222893|NCT00716417|Primary|Maximum Tolerated Dose (MTD) for Regimen A and Regimen B|The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||mg/m^2|||Number
1222894|NCT00716417|Primary|Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
1222895|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.|||units on a scale||Standard Error|Least Squares Mean
1222896|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction."|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
1222897|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Healthy Participants|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.|||participants||Standard Deviation|Mean
1222898|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
1222899|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Healthy Participants|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Deviation|Mean
1222900|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.|Baseline, 32 weeks|All healthy participants who had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1222910|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.|The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|From Week 16 Up to Week 32|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1223103|NCT00715403|Secondary|Unconfirmed Best Objective Response|Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
1222901|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 32 Weeks|All healthy participants who had baseline and post-baseline WJ III measurements.|||units on a scale||Standard Deviation|Mean
1222902|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.|||units on a scale||Standard Error|Least Squares Mean
1222903|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction."|Baseline, 16 Weeks|All participants who had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
1222904|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Healthy Participants|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Deviation|Mean
1222905|NCT00716274|Secondary|Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
1222906|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Healthy Participants|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.|Baseline, 16 weeks|All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Deviation|Mean
1222907|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1222908|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Deviation|Mean
1222909|NCT00716274|Secondary|Number of Participants With Adverse Events|Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|32 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1222911|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With Dyslexia|The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|From 16 Weeks Up to Week 32|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1222912|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.|The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|16 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1222913|NCT00716274|Secondary|The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia|The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|16 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1222914|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222915|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222916|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222917|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222918|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1223104|NCT00715403|Secondary|Unconfirmed Best Overall Response|"Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).~PD = Progressive disease."|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
1222919|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222920|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222921|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222922|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222923|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222924|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1223106|NCT00715403|Secondary|Clinically Relevant Abnormalities for Vital Signs|Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From baseline until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1222925|NCT00716274|Secondary|Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222926|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222927|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222928|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222929|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222930|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1223349|NCT00712270|Primary|Pre and Post Treatment PET and MRI Imaging||At baseline and 16 weeks|Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.||||||
1222931|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to 32 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1222932|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|From Week 16, Up to Week 32||2019-01-31|01/2019||||
1222933|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|From Week 16, Up to Week 32||2019-01-31|01/2019||||
1222934|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|From Week 16, Up to 32 Weeks||2019-01-31|01/2019||||
1222935|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|From Week 16, Up to Week 32||2019-01-31|01/2019||||
1222936|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222937|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222938|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age."|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222939|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age."|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222993|NCT00715962|Secondary|Life-Space Assessment Score|"The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. Life-space levels range from within one’s dwelling to beyond one’s town. A life-space composite score is calculated based on life-space level, degree of independence in achieving each level, and the frequency of attaining each level. Scores range from 0 - 120 with higher scores indicating greater community mobility."|4-6 weeks after baseline||||units on a scale||Standard Deviation|Mean
1222940|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222941|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222942|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WMTB-C measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222943|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222944|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222945|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222994|NCT00715962|Primary|Falls|Patients were asked daily during hospitalization to self-report any falls|18 months||||participants|||Number
1222995|NCT00715949|Secondary|To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.||study completion|||||||
1223105|NCT00715403|Secondary|Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)|Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29|Just before drug administration every 28±7 days after day 29|Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1222946|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222947|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222948|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222949|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222950|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222951|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1223006|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 3 years following primary vaccination|Analysis was performed on Total cohort at Year 3 which included all subjects vaccinated in the primary study and who came back to the visit at Year 3.|||Subjects|||Number
1223636|NCT00711009|Secondary|Mean Change From Baseline in Neutrophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1222952|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222953|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1222954|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.|||units on a scale||Standard Error|Least Squares Mean
1222955|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
1222956|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
1222957|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
1222958|NCT00716274|Secondary|Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
1222959|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
1222960|NCT00716274|Secondary|Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
1222961|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
1222962|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
1222963|NCT00716274|Secondary|Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
1222964|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1222965|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1222966|NCT00716274|Secondary|Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1222967|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a baseline and post-baseline WJ III measurement.|||units on a scale||Standard Error|Least Squares Mean
1222968|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a baseline and post-baseline WJ III measurement.|||units on a scale||Standard Error|Least Squares Mean
1222969|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a WJ III baseline and post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1222970|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, “ADD possible but not likely”. 40-54 equate to, “ADD probable but not certain”. 55-120 equate to, “ADD highly probable”. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
1222971|NCT00716274|Secondary|Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant’s word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Error|Least Squares Mean
1222972|NCT00716274|Primary|Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.|||units on a scale||Standard Error|Least Squares Mean
1222973|NCT00716274|Primary|Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Error|Least Squares Mean
1222974|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|Baseline, 16 Weeks||2019-01-31|01/2019||||
1222975|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With Attention Deficit Hyperactivity Disorder (ADHD) or ADHD + Dyslexia (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|Baseline, 16 Weeks||2019-01-31|01/2019||||
1222976|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|Baseline, 16 Weeks||2019-01-31|01/2019||||
1222977|NCT00716274|Primary|Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|Baseline, 16 Weeks||2019-01-31|01/2019||||
1222978|NCT00716144|Secondary|PASI75 at Each Post Baseline Visit Except Visit 6|PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)|MITT population.|||Participants|||Number
1222979|NCT00716144|Secondary|Investigator's Global Assessment (IGA) at Each Post Baseline Visit|The IGA was used to assess the overall severity of a participant’s plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant’s plaque psoriasis and recorded the one integer grade that best described the average, overall severity of the condition. Investigators were trained not to refer to previous assessments of the IGA, and not to base the IGA scores on any component of the PASI. Individual body regions were not assessed (as in the PASI), but rather a global evaluation for each participant at each visit was determined.|Week 1 to Week 20 (Visit 3 to Visit 8)|MITT population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the MITT Population.|||Participants|||Number
1222980|NCT00716144|Secondary|PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit|PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 1 to Week 20 (Visit 3 to Visit 8)|MITT population.|||Participants|||Number
1223007|NCT00715910|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 1 year following primary vaccination|Analysis was performed on Total cohort at Year 1 which included all subjects vaccinated in the primary study and who came back to the visit at Year 1.|||Subjects|||Number
1247064|NCT00530842|Secondary|Static Lung Volumes|Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1222981|NCT00716144|Primary|Psoriasis Area Severity Index (PASI)75 Success at Visit 6|PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 12 (Visit 6)|Modified Intent-to-Treat (MITT) population. MITT population comprised of all randomized participants who took study medication and provided post-Visit 2 efficacy data (i.e., had one on-therapy follow-up visit).|||Participants|||Number
1222982|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for Plasma Glucose AUEC (0-3h).|||mg*h/dL||Standard Error|Mean
1222983|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for FPG.|||mg/dL||Standard Error|Mean
1222984|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for GLP-1.|||pmol*h/L||Standard Error|Mean
1222985|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for WMG.|||mg/dL||Standard Error|Mean
1222986|NCT00716092|Secondary|Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).|Baseline and day 28|The pharmacodynamic set (PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo, further restricted to patients who had a baseline and at least one on-treatment value for Glucose AUEC(0-3h). Sitagliptin results from model with all 3 groups.|||mg*h/dL||Standard Error|Mean
1222987|NCT00716092|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for FPG. Sitagliptin results are from model containing all 3 groups|||mg/dL||Standard Error|Mean
1222988|NCT00716092|Primary|GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. Analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one ontreatment value for GLP-1. Sitagliptin results are from model containing all 3 groups.|||pmol*h/L||Standard Error|Mean
1222989|NCT00716092|Primary|Weighted Mean Glucose (WMG) Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for WMG. Sitagliptin results are from model containing all 3 groups|||mg/dL||Standard Error|Mean
1222990|NCT00716079|Secondary|Death at 90 Days||90 days||||participants|||Number
1222991|NCT00716079|Primary|A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)||90 days|In the intensive group 12 patients were alive at 90 days but missing data on mRS (required for primary outcome), and 9 patients in the guideline group|||participants|||Number
1222992|NCT00715962|Primary|Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers|Throughout the hospital stay, both the WP and UC patient wore a triaxial accelerometer on the ipsilateral thigh and ankle. The patient’s skin was assessed regularly to assure there is no evidence of irritation. The wireless monitors were used to quantify the amount of mobility that occurs daily for each patient with researchers being blinded to the outcome.|During hospital stay|Only data from those recording days during which sensors were worn for at least 12 hours, defined as a valid day recording, were considered for final analysis. The average out of bed activity (standing or walking) duration over valid days of recording for each person was reported.|||minutes/day||Standard Deviation|Mean
1222996|NCT00715949|Primary|The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.|In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Participation numbers were determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with minor traumatic brain injury (MTBI).|Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury.|Analysis population includes only subjects who completed computerized neurocognitive tests. 120 subjects began the study, however 4 dropped out because they were unable to complete the first test and were not included in the final number of analyzed participants.|||participants|||Number
1222997|NCT00715910|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1222998|NCT00715910|Secondary|Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)|Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1222999|NCT00715910|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1223000|NCT00715910|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1223001|NCT00715910|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1223002|NCT00715910|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|"Vaccine response was defined as:~For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination."|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Subjects|||Number
1223003|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1223004|NCT00715910|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Subjects|||Number
1223005|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 5 years following primary vaccination|Analysis was performed on Total cohort at Year 5 which included all subjects vaccinated in the primary study and who came back to the visit at Year 5.|||Subjects|||Number
1223251|NCT00713479|Primary|Diastolic Blood Pressure|Diastolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals||||mm Hg|Time Points|Standard Deviation|Mean
1223008|NCT00715910|Secondary|Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||μg/mL||95% Confidence Interval|Geometric Mean
1223009|NCT00715910|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values|The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1223010|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1223011|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1223012|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1223013|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1223014|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1223015|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1223016|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1223017|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1223018|NCT00715910|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1223019|NCT00715884|Secondary|Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.|31-360 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
1223020|NCT00715884|Secondary|Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.|0-30 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure.|||Percentage of participants|||Number
1223021|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)|"Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following:~DEFINITE - Angiographic or pathologic confirmation;~PROBABLE - Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent;~POSSIBLE - Any unexplained death > 30 days.~ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
1223022|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)|Protocol defined Stent thrombosis include both Early and Late Thrombosis. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave MI, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site-reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
1223023|NCT00715884|Secondary|Percentage of Participants Who Experienced Stroke|The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
1223024|NCT00715884|Secondary|Percentage of Participants Who Experienced Any Myocardial Infarction (MI)|Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
1223025|NCT00715884|Secondary|Percentage of Participants Who Died|Death incidences include both Cardiac and non-cardiac death.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
1223026|NCT00715884|Secondary|Percentage of Participants Who Experienced Bleeding Complications|Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and “Protocol” definitions.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
1223027|NCT00715884|Secondary|Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants who had diabetes and were followed up for 12 months.|||Percentage of participants|||Number
1223028|NCT00715884|Secondary|Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants with lesions of more than 1 vessel and were followed for 12 months|||Percentage of participants|||Number
1223029|NCT00715884|Secondary|Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)|MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1223030|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Failure (TVF)|Target Vessel failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1223031|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)|"TVR is defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1223032|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)|TLR is defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA.|12 months post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1223033|NCT00715884|Secondary|Percentage of Participants Who Achieved Procedure Success|Procedure success is defined as achievement of a final diameter stenosis of < 50 percent (by QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion during the hospital stay.|At procedure during hospital stay|Intent to Treat|||Percentage of participants|||Number
1223637|NCT00711009|Secondary|Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1223034|NCT00715884|Secondary|Percentage of Device Success - All CYPHER® Stents Included|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. All CYPHER® Stents were included if the final residual stenosis was <50%. Non-study CYPHER® Stents were also included.|At procedure|Intent to Treat population.|||Percentage of success|Participants||Number
1223035|NCT00715884|Secondary|Percentage of Device Success - Protocol Definition|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. Protocol definition: Only protocol-defined study stents were included.|At procedure|Intent to Treat population.|||Percentage of success|Participants||Number
1223036|NCT00715884|Secondary|Percentage of Lesion Success|Lesion success is defined as the attainment of < 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.|At procedure|ITT: All randomized participants regardless whether they received the intervention|||Percentage of success|Participants||Number
1223037|NCT00715884|Primary|Percentage of Participants Who Experienced Target Lesion Failure (TLF)|The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure. A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12-months post-procedure|Event-specific adjusted intent to treat (ITT) population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1223038|NCT00715793|Secondary|1-year Overall Survival (OS) Rate|Percentage of patients alive at one year (number of patients alive / total number of evaluable (analyzed) patients).|12 months||||percentage of participants|||Number
1223039|NCT00715793|Secondary|Overall Survival (OS)|OS was defined as the time from study entry until the death or date of last contract.|Up to 42 months||||months||95% Confidence Interval|Median
1223040|NCT00715793|Secondary|6-month Progression-free Survival (PFS) Rate||6 months|Patients that either progressed or died by 6 months.|||percentage of participants|||Number
1223041|NCT00715793|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from study entry until the documented radiological or symptomatic progression. Per RECIST v1.0 criteria (assessed by MRI or CT): Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions.|Up to 42 months||||months||Full Range|Median
1223042|NCT00715793|Secondary|Disease Control Rate (DCR)|Using RECIST v1.0 criteria, disease control rate (DCR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD). Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 30 months||||percentage of participants|||Number
1223043|NCT00715793|Primary|Recommended Phase 2 Dose (RP2D) of DAC + TMZ|Toxicity assessments used CTCAE v3.0. Two dose levels were explored in the phase I portion of the study. A modified 3 + 3 ‘up and down’ design was used. Given the knowledge that DAC exhibits its epigenetic effects at 30-fold lower doses than at its maximum-tolerated dose (MTD), escalation of DAC to the MTD was not done.|Up to 26 months||||mg/kg DAC|||Number
1223044|NCT00715793|Primary|Overall Response Rate (ORR)|Using RECIST v1.0 criteria, overall response rate (ORR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD), multiplied by 100. Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 30 months||||percentage of participants|||Number
1223045|NCT00715793|Primary|Percentage of Participants That Experienced a Dose Limiting Toxicity (DLT)|Dose-limiting toxicities (DLTs) were defined as grade 4 neutropenia or thrombocytopenia which lasts >7 days; grade 3 or 4 febrile neutropenia; grade 3 or greater non-hematological toxic effects.|Up to 26 months|Patients participating in the Phase 1 portion of the study that were treated on a standard “3+3” phase I dose-escalation design who were observed for unacceptable toxicities.|||percentage of participants|||Number
1223046|NCT00715754|Primary|Estimated Fetal Weight Percentile|Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation||||Percentile||Standard Deviation|Mean
1223047|NCT00715754|Primary|Fetal Abdominal Circumference|Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation||||cm||Standard Deviation|Mean
1223048|NCT00715754|Primary|Infant Adiposity at 24-72 Hours Following Birth|Adiposity as measured by air displacement plethysmography|24-72 hours following birth||||Percentage of total body weight||Full Range|Mean
1223049|NCT00715741|Secondary|SpO2 Postoperatively|SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.|24 hours after tracheal extubation||||percent saturation||Standard Deviation|Mean
1223050|NCT00715741|Secondary|"Arterial Oxygen Saturation by Pulse Oximetry (SpO2)"|SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%|45 min after tracheal extubation||||percent saturation||Standard Deviation|Mean
1223051|NCT00715741|Primary|Oxygen Requirement|amount of oxygen (LPM) required to maintain SpO2 >90%|24 hours after tracheal extubation||||liters per min||Inter-Quartile Range|Median
1223053|NCT00715728|Primary|Intraoperative Time Weighted Average Core Temperature|Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.|Until the end of surgery, up to 5 hour|Medical University of Vienna adults having major maxillary-facial reconstructive surgery expected to last about 5 h. Most had pectoral flap reconstructions after extensive cancer debridement. We did not study patients with Reynaud’s disease, thyroid dysfunction, insulin-dependent diabetes mellitus, or who were of ASA physical status > 3.|||degrees as measured in Celcius||Standard Error|Mean
1223054|NCT00715728|Primary|The Rate of Core Rewarming Over the Range From 35°C to 37°C.|The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.|Until the end of surgery, up to 5 hour||||degrees Celcius / hr||Standard Error|Mean
1223055|NCT00715676|Secondary|Number of Subjects With at Least 1 Treatment-emergent Adverse Event|To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.|1 year|The participants for this analysis included all randomized subjects who received a dose of study drug.|||Participants|||Number
1223056|NCT00715676|Secondary|Percent Change From Baseline in Serum Bone Markers at Week 26|Percent change from baseline at Week 26|Baseline and Week 26|Analyses were performed using subjects for whom both Baseline and Week 26 samples were available.|||Percent change||Standard Deviation|Mean
1223057|NCT00715676|Secondary|Change From Baseline in Serum Calcium Levels at Week 52|Change in serum calcium value (relative to baseline) at Week 52|Baseline and Week 52|This analysis was done for all subjects for whom both baseline and Week 52 data was available.|||mg/dL||Standard Deviation|Mean
1223058|NCT00715676|Secondary|Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52|Percent change in trochanter BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
1223059|NCT00715676|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52|Percent change in femoral neck BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
1223060|NCT00715676|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52|The percent change in hip BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was conducted on the Full Analysis Set, which included all randomized subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent Change||Standard Deviation|Mean
1223061|NCT00715676|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|Percent change in lumbar spine BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
1223062|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 6||||days||Standard Deviation|Mean
1223063|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 3||||days||Standard Deviation|Mean
1223064|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 1||||days||Standard Deviation|Mean
1223065|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Baseline||||days||Standard Deviation|Mean
1223066|NCT00715624|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration for up to 125 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1223067|NCT00715624|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1223068|NCT00715624|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223069|NCT00715624|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1223070|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1223071|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1223072|NCT00715624|Secondary|Change From Baseline in Total Insulin Dose at Week 24|Change was calculated for total insulin dose by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline total insulin dose assessment during on-treatment period.|||units per day||Standard Error|Least Squares Mean
1223073|NCT00715624|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1223074|NCT00715624|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223075|NCT00715624|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223076|NCT00715624|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223087|NCT00715520|Secondary|Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse|Mean sum of normalized MEP for repeated TMS (rTMS) conditions with respect to the pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Its amplitude is measured from peak to peak and expressed in mV. Long- lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||millivolts||Standard Deviation|Mean
1223077|NCT00715624|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. LOCF was used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1223078|NCT00715559|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|"The SAFTEE is used to measure somatic and other symptoms which may arise during the course of a clinical trial. This is a non-quantitative instrument that does not yield a numeric score. Instead, it provides study subjects the opportunity to check off symptoms listed on a checklist and indicate if the severity of the symptoms is mild moderate or severe. The reported values represent symptoms that were indicated at any point during the 8 week trial at a level of moderate or severe that also represented a change from a baseline-line pre-intervention SAFTEE assessment."|weekly, for 8 weeks|Study participants were assessed for side effects or adverse events with the SAFTEE at each study visit over the 8 week trial.|||symptoms||Standard Deviation|Mean
1223079|NCT00715559|Secondary|Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)|This is a self-report which measures the level of depression severity. I ranges from 0 (no illness) to 27 (severe illness).|8 weeks||||scale score||Standard Deviation|Mean
1223080|NCT00715559|Secondary|Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)|"This set of scales measures global improvement in a patient's level of symptoms, without reference to a particular condition (ie depression). GCI-S is a measure of severity, which ranges from 0 (not ill) to 7 (severely ill). CGI-I is a measure of change, with a score of 4 indicating no change, 1 indicating very much improved and 7 indicating very much worse."|8 weeks||||scale score||Standard Deviation|Mean
1223081|NCT00715559|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.|8 weeks|Mean MADRS score at end of treatment (LOCF) in 3 participants treated with cysteamine bitartrate.|||scale score||Standard Deviation|Mean
1223082|NCT00715520|Secondary|Aim 3: Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|No sufficient data collected.||||||
1223083|NCT00715520|Secondary|Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|No sufficient data collected.||||||
1223084|NCT00715520|Secondary|Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency|Mean peak acceleration for the different frequencies of rTMS treatment (placebo, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||g||Standard Deviation|Mean
1223085|NCT00715520|Secondary|Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency|Mean sum of normalized MEP for the different frequencies of rTMS treatment (placebo at 0.1 Hz, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||millivolts||Standard Deviation|Mean
1223086|NCT00715520|Secondary|Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse|Mean peak acceleration of wrist movements for repeated TMS (rTMS) conditions with respect of the TMS pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||g||Standard Deviation|Mean
1223101|NCT00715403|Secondary|Confirmed Objective Response|Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
1223102|NCT00715403|Secondary|Clinical Benefit|Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
1223088|NCT00715520|Primary|Aim 1: Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 1 participants per protocol. One subject was not included in the analysis due to corrupt data.|||g||Standard Deviation|Mean
1223089|NCT00715520|Primary|Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 1 participants per protocol for the placebo condition. One subject was not included in the analysis due to corrupt data.|||mV||Standard Error|Mean
1223090|NCT00715403|Primary|Difference From Baseline for Electrolytes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||mmol/L||Standard Error|Median
1223091|NCT00715403|Primary|Difference From Baseline for Coagulation Parameters|Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||sec||Standard Error|Median
1223092|NCT00715403|Primary|Difference From Baseline for Haematology and Differentials Parameters|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||10^9 /L||Standard Error|Median
1223093|NCT00715403|Primary|Difference From Baseline for Haemoglobin|Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From baseline until end of treatment, up to 991 days|Treated set.|||g/dL||Standard Error|Median
1223094|NCT00715403|Primary|Difference From Baseline for Bilirubin, Creatinine and Glucose|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||mg/dL||Standard Error|Median
1223095|NCT00715403|Primary|Difference From Baseline for Liver Enzymes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||U/L||Standard Error|Median
1223096|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5|All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1223097|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4|All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1223098|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3|All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1223099|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2|All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1223100|NCT00715403|Secondary|Progression Free Survival|"Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.~PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.~Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first."|First drug administration (in previous trial) until end of treatment, up to 1230 days|Treated set. Data for category|||percentage of participants|||Number
1223107|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1|All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1223108|NCT00715390|Primary|Arrhythmias During General Anesthesia in Children||July 1998 through July 2004||||participants|||Number
1223109|NCT00715299|Primary|The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.|Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.|Pre and post Treatment||||meters per second||Standard Deviation|Mean
1223110|NCT00715208|Secondary|Number of Patients Who Experienced at Least One Serious Adverse Event||From completion of informed consent through 30 days after the last dose of study drug|Safety Population: Treated patients|||participants|||Number
1223111|NCT00715208|Secondary|Duration of Response|"Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.~CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria."|2 years|Responders: CR + PR (Not done for VELCADE R-CAP, only 5 responders)|||Months||95% Confidence Interval|Median
1223112|NCT00715208|Secondary|Percentage of Participants With Progression-free Survival (PFS) at 1 Year|PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).|Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD|Safety population: Treated|||percentage of participants|||Number
1223113|NCT00715208|Secondary|Number of Participants With Overall Response (OR)|"OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.~CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET."|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to PD or death.|||participants|||Number
1223114|NCT00715208|Primary|Number of Patients With Complete Response (CR)|Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to progressive disease (PD) or death.|||participants|||Number
1223115|NCT00715117|Primary|Number of Patients Reporting Side Effects|Using adverse events and laboratory values Safety & toxicity were evaluated between those on placebo for 8 weeks and those on naltrexone for either 8 or 16 weeks.|8 weeks or 16 weeks|The Fisher Exact Test was used to evaluate the number of side effects reported between placebo and naltrexone groups. The Student T-test was used to evaluate the differences between the mena values of laboratory tests.|||participants|||Number
1223116|NCT00715117|Secondary|Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy|IMPACT III was a pediatric Crohn's specific quality of life survey used in this study. It examines five major categories influencing the quality of life in children with Crohn’s disease including bowel symptoms, systemic symptoms, emotional well-being, social well-being, and body image perception. The IMPACT-III uses 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life. So an increase in score denotes improved Quality of life.|16 weeks||||units on a scale||Standard Error|Mean
1223117|NCT00715117|Secondary|Pediatric Crohn's Disease Activity Index Score (PCDAI)|"Secondary outcome was efficacy on clinical activity. Mean pretreatment PCDAI scores in patients had moderate to severe disease activity at baseline were compared between those who received placebo for 8 weeks and those who received active experimental drug, naltrexone.~The PCDAI score is a number unit that is calculated from symptoms scores by the subject over a 7-day period prior to the visit, laboratory values, height & weight, and physical exam findings. A score of 10 and under denotes remission. Mild disease (score of 11-30); moderate disease (score of 31-45), a severe disease (scores greater than 45. A decline of 10 points or more is considered response to therapy. The score can range from 0 to >60 Patient must have a PCDAI score of equal or greater than 30 to qualify for this study (i.e., moderate to severe disease)."|Pretreatment and 8 weeks|The power calculations were performed using STPLAN version 4.1. The current investigation was designed as a pseudo-cross over study to increase the number of participants. In the proposed study, it was assumed that 80% would respond to naltrexone and that no more than 25% of the placebo.|||units on a scale||Standard Error|Mean
1223118|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.|||numbers of spots||Standard Error|Mean
1223119|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.|||number of spots||Standard Error|Mean
1223120|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.|The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.|||number of spots||Standard Error|Mean
1223121|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.|The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.|||numbers of spots||Standard Error|Mean
1223122|NCT00715104|Secondary|Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood|Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.|Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||numbers of spots||Standard Error|Mean
1223123|NCT00715104|Secondary|Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood|"Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays.~This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150–7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells."|Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||numbers of spots||Standard Error|Mean
1223124|NCT00715104|Secondary|Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster"|||cells/μm2||Standard Error|Mean
1223125|NCT00715104|Secondary|Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster"|||cells/μm2||Standard Error|Mean
1223126|NCT00715104|Primary|Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||cells/μm2||Standard Error|Mean
1223127|NCT00715078|Primary|Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.|An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.|Baseline, Months 2, 4 and 6.|Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject.|||Ratio ofCD54 molecules on BDS65:FP cells||Standard Error|Mean
1223128|NCT00715026|Secondary|Continued Assessment of Implant Survivorship and Incidences of Adverse Events.|A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination.|At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years||||adverse events|||Number
1223129|NCT00715026|Primary|Harris Hip Score|The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.|Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years|Data was received on 24 subjects/25 hips at preop, on 17 subjects/18 hips at 3 months, and on 4 subjects at 1 year prior to the early termination of the study. Each hip, whether unilateral or bilateral, was counted separately. Early study termination was done due to voluntary removal of the device from the US market.|||units on a scale||Standard Deviation|Mean
1223130|NCT00714948|Primary|To Determine the Progression Free Survival Rate at One Year Untreated Patients With Advanced/Metastatic Urothelial Carcinoma Treated With the Combination of Sorafenib, Gemcitabine, and Cisplatin.||conclusion of the study|||||||
1223252|NCT00713479|Primary|Systolic Blood Pressure|Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|Per protocol|||mm Hg|time points|Standard Deviation|Mean
1223131|NCT00714870|Primary|Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)|"Using a validated quality of life questionnaire we analyzed change in child self-report scores comparing baseline questionnaire scores to end of study questionnaire scores for these categories: total (includes physical and psychosocial), physical, and psychosocial(includes emotional, social, and school).~Scale information: The range is 0-100 in terms of points they could get for each category. They had the options of 0-4, 0 being the best. 0 would then be transformed to a score of 100, 1 to 75, 2 to 50, 3 to 25 and 4 to 0.~Results are clinically significant if the difference in scores are higher than the Minimal Clinical Important Difference (MCID). MCID are as follows: Total Score: 4.36, Physical Health: 6.66, Psychosocial Health: 5.30."|one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later|To detect an effect with greater than or equal to 80% power at a 0.05 two sided significant level, we concluded we needed 22 participants completing each group, intervention and control|||units on a scale||Standard Deviation|Mean
1223132|NCT00714792|Primary|Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation|Sterile specimens were obtained from subjects. The urethra was prepared with Betadine and an 8Fr urethral catheter passed into the bladder and urine obtained in a sterile container. Bladder washings were obtained after urine was completely emptied from the bladder via the catheter. Saline (60ccs) was used to vigorously irrigate the bladder 2-3 times through the 8 Fr catheter. The bladder washings were then collected and placed in a sterile container. The experimental cultures included 100ml inoculated on Blood Agar, MacConkey Agar and Brucella Blood Agar, incubated for 72 hours at 35-37 C in ambient atmosphere supplemented with 5-8% carbon dioxide. Colonies were counted to quantify the cfu/ml and all growth of any organism was reported. Organisms were then identified using standard microbiologic techniques.|within one week of enrollment|One overactive bladder subject had greater than 100,000 cfu in routine culture and their specimens were excluded from the analysis.|||participants|||Number
1223133|NCT00714753|Secondary|Freedom From Salvage Androgen Suppression Treatment|Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from salvage androgen suppression therapy.|From baseline to 5 years after registration|With only 5 patients, the study team deemed that this information would be unsuitable.||||||
1223134|NCT00714753|Secondary|Freedom From Biochemical and Clinical Failure|Freedom from biochemical and clinical failure, will be analyzed using Kaplan-Meier procedures. Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from biochemical and clinical failure.|From baseline to 5 years after registration|With only 5 patients, the study team deemed that the information would be unsuitable.||||||
1223135|NCT00714753|Secondary|Changes in Health-related Quality of Life Scores|A pretest-posttest design will be employed to detect changes in HRQOL scores over time. The HRQOL scores will be calculated per assessment, as appropriate. Each construct will be standardized to a range of 0-100 so that comparison across constructs is facilitated. Sets of difference scores will be computed: 1) differences between baseline and treatment completion (at 1 month post treatment follow up), and 2) differences between treatment completion and all post-treatment follow-up examinations for up to five years after finishing the protocol treatment (see Section 4.1 for specific HRQOL instruments to be completed at follow-up visits). The first analysis will allow for determination of the short-term impact of treatment on HRQOL, while the second will investigate the long-term treatment effect. Student’s t-test methodology will be applied to the differences at end of treatment (1 month post treatment follow up) and at each follow-up.|From baseline to 5 years after registration|None of the enrolled patients were analyzed for this endpoint due to too few patients.||||||
1223136|NCT00714753|Secondary|Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)|Patient preference for second treatment (group 1 or group 2) will be assessed using a Treatment Preference Questionnaire (Appendix IX) developed specifically for this study. Qualitative and quantitative analyses will be performed on patient responses to the questions posed after choosing their second treatment in an exploratory fashion.|From baseline until the end of the first treatment|None of the enrolled patients were analyzed for this endpoint due to too few patients.||||||
1223137|NCT00714753|Secondary|Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events|Dose-volume limitations for organs at risk will be analyzed byassociating GU or GI AEs (both rate and severity) with dosimetric parameters using simple correlational methods. These parameters will include (1) bladder V80, V60, V50, and Dmax; (2) penile bulb median dose; (3) rectum V80, V60, V50 and Dmax; and (4) urethra V120, V110, V100, and Dmax.|From baseline to 5 years after registration|No patients registered to a dose escalation Phase I group were analyzed for this endpoint. With only 5 patients, the study team deemed that the information would be unsuitable.||||||
1223138|NCT00714753|Primary|Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)|Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade >3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs.|From baseline to 3 years after registration|All patients registered to a dose escalation Phase I group were analyzed for this endpoint. Only 1 patient was registered to the HDR+EBRT arm. Due to protected health information, listing only 1 patient's results is contraindicated.|||Acute >3, Late 2, or ≥3 grade events|||Number
1223139|NCT00714714|Primary|Assessment of Facial Irritation and Cutaneous Effects|Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)|cumulative daily weekday scores for two weeks|One panelist terminated treatment on Day 2. Her scores were carried over and the analysis was based on Intention to Treat (ITT).|||Ordinal data treated as interval||Standard Deviation|Mean
1223153|NCT00714415|Secondary|Assessment of Treatment Handling by the Participants|Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1223140|NCT00714688|Secondary|Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score|The CAARS-S:S is a 26-item self-report scale that measures symptoms based on the DSM-IV criteria for ADHD. Respondents were asked to rate items pertaining to their behavior/problems using the following 4-point scale (from 0 = Not at all, never; to 3 = Very much, very frequently). The CAARS-S:S total score range is from 0 (best) to 78 (worse). The change in CAARS-S:S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set. It excludes patients for which a baseline value was missing.|||units on a scale||Standard Deviation|Mean
1223141|NCT00714688|Secondary|Clinical Global Impression-Change (CGI-C)|The CGI-C rating scale is used to rate the change in severity of the subject's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.It excludes patients for which either a baseline or end of treatment value was missing.|||units on a scale||Full Range|Median
1223142|NCT00714688|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment|The CGI-S rating scale is used to rate the severity of a subject's illness on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe illness). The change in CGI-S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.|||units on a scale||Full Range|Median
1223143|NCT00714688|Primary|Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)|The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed.|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.|||units on a scale||Standard Deviation|Mean
1223144|NCT00714571|Primary|Memory Test Accuracy on Trained Stimuli|Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test|Pre-training, post-training, 1 month|MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study|||Percent correct||Standard Deviation|Mean
1223145|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Weeks 26.|Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient’s assessment of pain visual analog scale (VAS), Patient’s global assessment of disease activity (VAS), Evaluator’s global assessment of disease activity (VAS), Patient’s assessment of physical function as measured by the HAQ disability index, and CRP.|Week 26||||percentage|||Number
1223146|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Week 10|Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient’s assessment of pain visual analog scale (VAS), Patient’s global assessment of disease activity (VAS), Evaluator’s global assessment of disease activity (VAS), Patient’s assessment of physical function as measured by the HAQ disability index, and CRP.|Week 10||||percentage|||Number
1223147|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 26||||scale -3 to 3||Standard Deviation|Mean
1223148|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 10||||scale -3 to 3||Standard Deviation|Mean
1223149|NCT00714493|Secondary|Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26|Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26|Week 26||||percentage|||Number
1223150|NCT00714493|Secondary|Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase|Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase|Week 26||||percentage|||Number
1223151|NCT00714493|Primary|Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10|Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.|Week 10|The evaluable population was the subset of the mITT population (included the enrolled patients who received at least 1 dose of study medication) after excluding all 6 patients from Site 8631 where significant trial misconducts were identified.|||Percentage|||Number
1223152|NCT00714415|Secondary|Investigator Assessment of Treatment Satisfaction of Participants|Investigator evaluated the participant’s satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied.|Baseline up to 8.7 years|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1223154|NCT00714415|Secondary|Assessment of Treatment Efficacy by the Participants|Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1223155|NCT00714415|Secondary|Investigator Assessment of Treatment Handling of Participants|Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1223156|NCT00714415|Secondary|Investigator Assessment of Treatment Efficacy of Participants|Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1223157|NCT00714415|Secondary|Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work|Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement was defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.|Baseline, up to 8.7 years|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1223158|NCT00714415|Secondary|Mean Total Number of Bleeding Episodes Per Year in Participants|Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.|Baseline until last visit (up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||bleeding episodes per year||Standard Deviation|Mean
1223159|NCT00714415|Secondary|Mean Total Number of Bleeding Episodes in Participants|Participants documented all bleeding episodes in a diary during the study.|Baseline until last visit (up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||bleeding episodes||Standard Deviation|Mean
1223160|NCT00714415|Primary|Participant Assessment of Treatment Tolerability|Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1223161|NCT00714415|Primary|Investigator Assessment of Treatment Tolerability of Participants|Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1223162|NCT00714415|Primary|Number of Participants With Adverse Events (AEs) of Special Interest|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity.|Baseline until last visit (up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.|||participants|||Number
1223163|NCT00714415|Primary|Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay|FIX inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.|Baseline until last visit (up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.|||participants|||Number
1223164|NCT00714415|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious. Relatedness to BeneFIX was assessed by the investigator.|Baseline until last visit (up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.|||participants|||Number
1223183|NCT00714285|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Days 0 and 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1223253|NCT00713349|Primary|Complete Wound Closure|Each subject acting as their own control|21 Days||||days||Standard Deviation|Mean
1223165|NCT00714415|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.|Baseline until last visit (up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.|||participants|||Number
1223166|NCT00714389|Primary|Maximal Flow Rate|Maximal uroflow of spontaneous subject voids|March 2008||||mL/sec||Standard Deviation|Mean
1223167|NCT00714389|Primary|Voided Volume|Volume of spontaneous void|March 2008||||mL||Standard Deviation|Mean
1223168|NCT00714311|Secondary|Borderline Symptomatology (DSM-IV Criteria)||1 month|||||||
1223169|NCT00714311|Secondary|Attachment Style and Reflective Function (Adult Attachment Interview, AAI)||1 year|||||||
1223170|NCT00714311|Secondary|Self-assessment of Psychopathology (BDI, STAI, BSI)||1 year|||||||
1223171|NCT00714311|Secondary|Number of Self-harming Acts||1 year|||||||
1223172|NCT00714311|Secondary|Level of Personality Organization (Structured Interview for Personality Organization, STIPO)||1 year|||||||
1223173|NCT00714311|Secondary|Psychosocial Functioning (Global Assessment of Functioning, GAF-Score)||1 year|||||||
1223174|NCT00714311|Primary|Suicidality (Suicide Attempts)||1 year|||||||
1223175|NCT00714311|Primary|Drop-out|Did not finish one year of treatment.|1 year||||participants|||Number
1223176|NCT00714285|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
1223177|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination|During a 21 day (Days 0-20) follow-up period after vaccination-|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
1223178|NCT00714285|Secondary|Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).|MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
1223179|NCT00714285|Secondary|Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.|Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed|||Subjects|||Number
1223180|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed|||Subjects|||Number
1223181|NCT00714285|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.|Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.|||Subjects|||Number
1223182|NCT00714285|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During a 7 day (Days 0-6) follow-up period after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.|||Subjects|||Number
1223184|NCT00714285|Secondary|HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1223185|NCT00714285|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1223186|NCT00714285|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1223187|NCT00714259|Primary|Progression Free Survival Post Transplant|Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.|2 years post transplant||||participants|||Number
1223188|NCT00714259|Primary|Progressive Free Survival Post Transplant|Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|365 days post transplant||||participants|||Number
1223189|NCT00714259|Primary|Progressive Free Survival Post Transplant|Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|180 days post transplant||||participants|||Number
1223190|NCT00714259|Secondary|Composite Incidence of Acute and Chronic Graft Versus Host Disease||Up to 100 days post transplant.||||participants|||Number
1223191|NCT00714259|Secondary|Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant|Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.|Post transplant up to 100 days post transplant||||participant|||Number
1223192|NCT00714259|Secondary|Non-relapse Treatment Related Mortality|Death related to treatment without relapse within 100 days after transplant|Within 100 days post transplant||||participants|||Number
1223193|NCT00714259|Primary|Progressive Free Survival Post Transplant|subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|100 days post transplant||||participants|||Number
1223194|NCT00714233|Secondary|Change in Fasting Glucose|Change in fasting glucose concentration by treatment group pre to post intervention|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
1223195|NCT00714233|Secondary|Triglyceride Concentration by Treatment Group|Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
1223196|NCT00714233|Secondary|Change in SHBG|Measurement of SHBG by treatment group pre and post intervention|baseline and 24 weeks||||ratio||Standard Deviation|Mean
1223197|NCT00714233|Secondary|Change in Free Androgen Index (FAI)|Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.|baseline and 24 weeks|analysis per protocol|||total T/SHBG||Standard Deviation|Mean
1223198|NCT00714233|Secondary|Weight Loss in Lifestyle Intervention Group|In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI|baseline and 24 weeks|Analysis per protocol|||kg/m^2||Standard Deviation|Mean
1223199|NCT00714233|Primary|Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification|The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY|24 week|Analysis was a description of number of recruited subjects.|||participants|||Number
1223200|NCT00714168|Secondary|Body Composition|Change in Percent Body Fat from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis|||percent body fat||95% Confidence Interval|Least Squares Mean
1223201|NCT00714168|Secondary|Cardiovascular Fitness|Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.|||minutes||95% Confidence Interval|Least Squares Mean
1223202|NCT00714168|Secondary|Energy Intake|Change in Energy Intake from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects analyzed.|||kcal/day||95% Confidence Interval|Least Squares Mean
1223203|NCT00714168|Secondary|Physical Activity|Change in Physical Activity from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.|||kcal/week||95% Confidence Interval|Least Squares Mean
1223204|NCT00714168|Primary|Weight Loss|Change in Weight from Baseline|Measured at Month 18|We used an intention-to-treat analysis with all randomized subjects included in the analysis.|||kg||95% Confidence Interval|Least Squares Mean
1223205|NCT00714051|Primary|Number of Participants Who Fell on a Tripping Test|Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.|4 weeks||||participants|||Number
1223206|NCT00713830|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 120 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The one patient in the placebo group who received Lixisenatide was analyzed in the Lixisenatide group|||participants|||Number
1223207|NCT00713830|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1223208|NCT00713830|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1223209|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1223210|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1223211|NCT00713830|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|The fasting C-peptide and the 2-hour postprandial C-peptide blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. here. number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||nmol/L||Standard Error|Least Squares Mean
1223212|NCT00713830|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|The fasting proinsulin-to-insulin ratio and 2-hour postprandial proinsulin-to-insulin ratio were measured during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data imputed using LOCF. Number of patients analyzed=patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n'= patients with baseline and at least 1 post-baseline assessment for the specific category.|||ratio||Standard Error|Least Squares Mean
1223638|NCT00711009|Secondary|Mean Change From Baseline in Platelet Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1223213|NCT00713830|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|The fasting Proinsulin and the 2-hour postprandial Proinsulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
1223214|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin at Week 24|The fasting plasma insulin and the 2-hour postprandial plasma insulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
1223215|NCT00713830|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|The fasting glucagon and the 2-hour postprandial glucagon blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||ng/L||Standard Error|Least Squares Mean
1223216|NCT00713830|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223217|NCT00713830|Secondary|Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta blood samples were drawn during a standardized meal challenge test (performed in selected sites). HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
1223218|NCT00713830|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1223219|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223305|NCT00712725|Secondary|Absence of Phonophobia|Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1223220|NCT00713830|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG blood sample was drawn 2 hours after start of a standardized meal (standardized meal challenge test performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223221|NCT00713830|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-Treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1223222|NCT00713817|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study is presented.|Day 0 -35|The safety analysis set comprised all subjects who received at least one dose of study medication.|||participants|||Number
1223223|NCT00713817|Secondary|Subject Global Impression of Change at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your nerve pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of subjects wo reported an improvement is presented.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1223224|NCT00713817|Secondary|Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The sleep disruption Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223225|NCT00713817|Secondary|Number of Subjects With More Than a 20% Loss of Response at the End of Treatment|The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1223226|NCT00713817|Secondary|Number of Subjects Who Failed Treatment at the End of the Treatment Period|"Treatment failure was defined as follows:~A. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr:~B. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline."|Day 7 to time of last dose|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1223227|NCT00713817|Secondary|Change From Baseline Neuropathic Pain Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223228|NCT00713817|Primary|Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223229|NCT00713700|Primary|The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.|The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.|180 days|Of the 192 enrolled, 178 subjects experienced successful device placement.Of the 178 subjects with the device implanted,166 had a 6-month TTE and physical examination before 200 days post procedure or had an explant before the 6-month follow-up interval ended.|||percentage of participants||95% Confidence Interval|Number
1223639|NCT00711009|Secondary|Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^12/liter||Standard Deviation|Mean
1223230|NCT00713700|Primary|The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.|"The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure~SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event."|180 days|Of the 192 enrolled subjects, 188 completed follow-up through 180 days post procedure;3 subjects were lost to follow-up (LTFU) before the 180-day interval and 1 subject was discontinued at the end of the 6-month visit without follow-up.|||percentage of participants||95% Confidence Interval|Number
1223231|NCT00713661|Secondary|The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.|Day of surgery|Data are presented for the 25 subjects treated with TachoSil®. They constitute the intention-to-treat (ITT) and the safety analysis set.|||participants|||Number
1223232|NCT00713661|Primary|The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.|Day of surgery|"ITT + Safety Analysis Set.~All applications recorded as “not feasible” by external assessor was because he was not able to see it all the way around the anastomosis. The implication is that the primary endpoint was not really reporting the true feasibility, as it was hindered due to technical/practical problems recording the whole anastomosis."|||participants|||Number
1223233|NCT00713648|Secondary|Number of Subjects With rFXIII Antibody Development|Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit)|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - Subjects who received at least one dose of trial product.|||participants|||Number
1223234|NCT00713648|Secondary|Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.|||U/kg||Standard Deviation|Mean
1223235|NCT00713648|Secondary|Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.|||percentage (%) of subjects|||Number
1223236|NCT00713648|Primary|Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period|It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product.|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product.|||bleeding episodes per subject per year||Full Range|Mean
1223237|NCT00713609|Secondary|Proportion of Participants With an ISGA Score of 0 or 1 at Week 12|An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.|Week 12|ITT Analysis Set|||Percentage of participants|||Number
1223249|NCT00713479|Secondary|Depression|Using the Beck Depression Index (BDI-II), depression was assessed on a daily basis. The daily mean score during the medication intervention period is presented, with a lower score indicating lower reported depression. The scores range from 0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression.|Daily||||units on a scale|Total BDI|Standard Deviation|Mean
1223250|NCT00713479|Primary|Heart Rate|Heart rate is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals||||bpm|Time Points|Standard Deviation|Mean
1223238|NCT00713609|Secondary|Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)|The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).|Baseline and up to Week 12|ITT Analysis Set|||Percent change||Standard Deviation|Mean
1223239|NCT00713609|Primary|Proportion of Participants With a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.|Baseline and up to Week 12|ITT Analysis Set|||Percentage of participants|||Number
1223240|NCT00713609|Primary|Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12|The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).|Baseline and up to Week 12|Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.|||Lesion count||Standard Deviation|Mean
1223241|NCT00713596|Primary|Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity|"ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied).~NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem).~Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose"|6 months post operative|||||||
1223242|NCT00713596|Secondary|Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire|At the end of the study standard post operative rhinoplasty photos will be obtained, and the photos will be reviewed by three blinded observers, who are experienced rhinoplasty surgeons. The photos will be presented to the evaluators in a completely random fashion at a single session. These photos will be graded at that time using the same questionnaire used by the operating surgeon. The questionnaire covers bruising, swelling, tenderness, and length, width, hump and tip of nose, with a range 4-40, 4=ideal nose to 40=many postoperative problems and disfigured nose.|6 months postoperative|||||||
1223243|NCT00713583|Primary|Confirmed Abstinence From Cocaine as Assessed by Treatment Effectiveness Score (TES)|The Treatment Effectiveness Score (TES) is the number of cocaine-negative urines collected out of the total scheduled urine tests for the 12-week trial (36 total scheduled urine tests per participant). The mean number of cocaine-negative urines over all time points is reported in this outcome measure.|12 weeks of treatment||||cocaine-negative urines||Standard Deviation|Mean
1223244|NCT00713544|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months’ treatment, calculated as score at 12 Weeks minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability.|Baseline to 12 Weeks||||Units on a scale||Standard Deviation|Mean
1223245|NCT00713544|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28)|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of disease activity; and ESR) after 12 Weeks’ treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms.|Baseline to 12 Weeks||||Units on a scale||Standard Deviation|Mean
1223246|NCT00713544|Secondary|American College of Rheumatology 70 Response (ACR70)|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks||||Participants|||Number
1223247|NCT00713544|Secondary|American College of Rheumatology 50 Response (ACR50)|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks||||Participants|||Number
1223248|NCT00713544|Primary|American College of Rheumatology 20 Response (ACR20)|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks||||Participants|||Number
1223254|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks)|"The patient was asked on a scale of ‘0 to 10’ please indicate the average level of your intoxication due to medications over the last 24 hours (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223255|NCT00713323|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).|42 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||participants|||Number
1223256|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223257|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223258|NCT00713323|Secondary|Subject Global Impression of Change|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|week 38|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||participants|||Number
1223259|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223260|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223261|NCT00713323|Primary|Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223262|NCT00713310|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and Week 6|mITT subjects who were randomized & took at least one dose of study medication|||% participants with treatment success|||Number
1223263|NCT00713310|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and 6 weeks|miTT includes subjects who were randomized and took at least one dose of study medication|||% participants with treatment success|||Number
1223303|NCT00712725|Secondary|Sustained Pain Freedom (SPF)|Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.|2-24 hours postdose|Full Analysis Set (FAS), which included all randomized participants who met the FAS criteria for PF at 2 hours postdose, and who, between 2-24 hours posedose, either 1) did not have PF at any time, 2) used rescue, or 3) answered the 24 hour recurrence question.|||Participants|||Number
1223346|NCT00712335|Secondary|Sputum Eosinophil Percentages|Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups|24 weeks|We will use ITT and PP protocols for analysis|||percentage of eosinophils||Standard Deviation|Mean
1223264|NCT00713258|Secondary|Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment|"Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person’s functional level is restricted by pain.~ODI scores from 0 = no disability to 100 = maximum disability.~Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status."|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."|||scores on a scale||Standard Deviation|Mean
1223265|NCT00713258|Primary|Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.|The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = “no pain” and 10 = “unendurable pain”).|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."|||points on a scale||Standard Deviation|Mean
1223266|NCT00713219|Primary|Overall Progression-Free Survival (PFS).|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|conclusion of the study||||Days||Full Range|Mean
1223267|NCT00713206|Secondary|Crestal Bone Regression||four years||2018-12-31|12/2018||||
1223268|NCT00713206|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis|3 year|Number of participants used in analysis selected as per protocol|||participants|Number of implants analyzed||Number
1223269|NCT00712985|Primary|Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months|17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.|One year||||participants|||Number
1223270|NCT00712959|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose|"Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1223271|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
1223272|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
1223273|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:~≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or~≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or~≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ."|Day 30 post-vaccination|Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.|||Percentage of Particpants|||Number
1223274|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Anti-diphtheria or anti-tetanus booster responses were defined as:~Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response."|Day 30 post-vaccination|Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.|||Percentage of Participants|||Number
1223275|NCT00712959|Primary|Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
1223276|NCT00712959|Primary|Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose|"Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).~Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL."|Day 0 (pre-vaccination) and 30 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.|||Percentage of Participants|||Number
1223277|NCT00712933|Primary|Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit|The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score – Baseline score) > 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
1223278|NCT00712933|Primary|Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit|Participants who had improving SLE disease activity for at least 8 weeks, at the investigator’s discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.|Up to 9 years|MITT Population|||Participants|||Number
1223279|NCT00712933|Primary|Number of Participants With IgG Values Below the Lower Limit of Normal by Year|Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
1223280|NCT00712933|Primary|Number of Participants With Immunogenic Response by Year|Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
1223281|NCT00712933|Primary|Change From Baseline in Immunoglobulin G (IgG) Levels|Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||g/L||Standard Deviation|Mean
1223282|NCT00712933|Primary|Change From Baseline in Bilirubin (Bili) Levels|Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||µmol/L||Standard Deviation|Mean
1223283|NCT00712933|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels|Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||International Units/liter (IU/L)||Standard Deviation|Mean
1223284|NCT00712933|Primary|Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1223285|NCT00712933|Primary|Change From Baseline in BUN and Glucose at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||mmol/L||Standard Deviation|Mean
1223286|NCT00712933|Primary|Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Grams per liter (g/L)||Standard Deviation|Mean
1223287|NCT00712933|Primary|Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to 9 years|MITT Population|||Ratio||Standard Deviation|Mean
1223288|NCT00712933|Primary|Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points|Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1223289|NCT00712933|Primary|Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Trillions cells per liter||Standard Deviation|Mean
1223290|NCT00712933|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Percentage of blood by volume||Standard Deviation|Mean
1223291|NCT00712933|Primary|Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Gram per liter (g/L)||Standard Deviation|Mean
1223304|NCT00712725|Secondary|Absence of Nausea|Absence of nausea at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1223292|NCT00712933|Primary|Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Billion cells per liter||Standard Deviation|Mean
1223293|NCT00712933|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point|Baseline and up to 9 years|MITT Population|||Seconds||Standard Deviation|Mean
1223294|NCT00712933|Primary|SAE Rates by SOC During the Study|SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to 9 years|MITT Population|||Adverse events per 100 participant years|Subject years||Number
1223295|NCT00712933|Primary|Number of Participants With Serious Adverse Events (SAE)|An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.|Up to 9 years|MITT Population|||Participants|||Number
1223296|NCT00712933|Primary|AE Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to 9 years|MITT Population|||Adverse events per 100 participant years|Subject years||Number
1223297|NCT00712933|Primary|Number of Participants With Adverse Events (AE)|An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.|Up to 9 years|MITT Population|||Participants|||Number
1223298|NCT00712920|Secondary|Change From Baseline on Direct Visual Nasal Exams and 28 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 28 days|ITT|||Participants|||Number
1223299|NCT00712920|Secondary|Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days|A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.|baseline and 28 Days|ITT|||Units on a Scale||Standard Deviation|Least Squares Mean
1223300|NCT00712920|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days|Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.|baseline and 28 days|ITT|||Scores on a Scale||Standard Deviation|Least Squares Mean
1223301|NCT00712920|Secondary|Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day."|baseline and 28 days|ITT|||Scores on a Scale||Standard Deviation|Least Squares Mean
1223302|NCT00712920|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.|"Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day~Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 28 days|ITT|||Scores on a Scale|||Number
1223306|NCT00712725|Secondary|Absence of Photophobia|Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1223307|NCT00712725|Secondary|Pain Relief (PR)|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose.~Rating of Headache Severity (Scale from Grade 0 to 3):~Grade 0: No pain~Grade 1: Mild pain~Grade 2: Moderate pain~Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1223308|NCT00712725|Primary|Pain Freedom (PF)|"Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose.~Rating of Headache Severity (Scale from Grade 0 to 3):~Grade 0: No pain~Grade 1: Mild pain~Grade 2: Moderate pain~Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1223309|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1223310|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1223311|NCT00712673|Secondary|Percentage of Patients Requiring Rescue Therapy During the Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1223312|NCT00712673|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1223313|NCT00712673|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1223314|NCT00712673|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
1223315|NCT00712673|Secondary|Change From Baseline in Adiponectin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline adiponectin assessment during on-treatment period.|||mcg/mL||Standard Error|Least Squares Mean
1223316|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.|||ng/L||Standard Error|Least Squares Mean
1223317|NCT00712673|Secondary|Change From Baseline in Fasting Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.|||ng/L||Standard Error|Least Squares Mean
1223318|NCT00712673|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal teat. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223319|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.|||nmol/L||Standard Error|Least Squares Mean
1223320|NCT00712673|Secondary|Change From Baseline in Fasting C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.|||nmol/L||Standard Error|Least Squares Mean
1223321|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
1223322|NCT00712673|Secondary|Change From Baseline in Fasting Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
1223323|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PPI assessment during on-treatment period|||pmol/L||Standard Error|Least Squares Mean
1223324|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
1223347|NCT00712270|Secondary|Assessment of Pretreatment and Posttreatment Psychiatric Rating Scales to Include PANSS and CGI|Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.|7 visits over 16 weeks|Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.||||||
1223325|NCT00712673|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1223326|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223327|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1223328|NCT00712673|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1223329|NCT00712543|Primary|Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.||14 days||||participants|||Number
1223330|NCT00712530|Other Pre-specified|Change in HIV-specific Memory T Cell Responses at Week 48|"HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.~Note, group Single low-dose was measured at 24 weeks, for this group the 48 weeks data is not available"|48 weeks||||PHPC count||Standard Deviation|Mean
1223331|NCT00712530|Secondary|Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline|HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.|28 days||||PHPC count||Standard Deviation|Mean
1223332|NCT00712530|Secondary|Number of Subjects Having More Than 50 Copies/mL HIV RNA||28 days||||participants|||Number
1223333|NCT00712530|Secondary|Number of Subjects With Detectable Anti-ds Antibody and ANA||28 days||||participants|||Number
1223334|NCT00712530|Secondary|CD4+ T Cell Counts/mm3||28 days||||CD4+ T cell counts/mm3||Standard Deviation|Mean
1223335|NCT00712530|Primary|Grade 3 Adverse Event Related to DermaVir Treatment|Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.|28 days||||participants|||Number
1223336|NCT00712348|Primary|Hemoglobin||Every 3 months from Baseline to Month 9||||g/dL||Standard Deviation|Mean
1223337|NCT00712348|Other Pre-specified|Liver Volume|Liver volume measured by MRI|Baseline and 9 months|2 patients were MRI phobic|||mL||Standard Deviation|Mean
1223338|NCT00712348|Other Pre-specified|Spleen Volume|Spleen volume measured by MRI in mL|Baseline and 9 Months|25 patients had spleen volume measured by MRI, 2 were MRI phobic and 3 were splenectomized|||mL||Standard Deviation|Mean
1223339|NCT00712348|Other Pre-specified|Platelet Count||Every 3 months from Baseline to Month 9||||platelets/mm^3||Standard Deviation|Mean
1223340|NCT00712335|Secondary|Sputum RANTES Levels|Week 24 sputum RANTES levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.|||pg/ml||Standard Deviation|Mean
1223341|NCT00712335|Secondary|Sputum Eotaxin Levels|Week 24 sputum eotaxin levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.|||pg/ml||Standard Deviation|Mean
1223342|NCT00712335|Secondary|Sputum IFN-gamma/IL-5 Ratios|Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.|24 weeks|ITT and PP were used for analysis.|||ratio||Standard Deviation|Mean
1223343|NCT00712335|Secondary|Sputum GM-CSF Levels|Week 24 sputum GM-CSF levels in active treatment groups were measured.|24 weeks|We will use ITT and PP for analysis|||pg/ml||Standard Deviation|Mean
1223344|NCT00712335|Secondary|Sputum IL-8 Levels|Week 24 sputum IL-8 levels in active treatment groups|24 weeks|We will ITT and PP protocols for analysis|||pg/ml||Standard Deviation|Mean
1223345|NCT00712335|Primary|Sputum Neutrophil Percentages|Week 24 sputum neutrophil percentages were measured in active treatment groups.|24 weeks|We will be using intention-to-treat and per protocol for analysis.|||percentage of neutrophils||Standard Deviation|Mean
1223350|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during intraocular lens (IOL) insertion. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
1223351|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
1223352|NCT00712244|Secondary|Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during anterior capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
1223353|NCT00712244|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure is between 10 mmHg and 20 mmHg.|1 day after surgery|This data was collected on all subjects attending the visit one day after surgery with the exception of 3 DisCoVisc subjects, 4 DuoVisc subjects, 2 Healon5 subjects, and 1 AmVisc Plus subject.|||mmHg||Standard Deviation|Mean
1223354|NCT00712244|Secondary|Aqueous Signs - Aqueous Cells|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings: 0 - None, 1 - 1 to 5 cells, 2 - 6 to 15 cells, 3 - 16 - 30 cells, 4 - >30 cells.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of participants|||Number
1223355|NCT00712244|Secondary|Aqueous Signs - Aqueous Flare|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings: 0 - None: No visible flare when compared to the normal eye, 1 - Mild: Flare visible against dark papillary background but not visible against iris background, 2 - Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as teh dark papillary background, 3 - Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.|1 Day after Surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of participants|||Number
1223356|NCT00712244|Secondary|Aqueous Signs - Corneal Edema|Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings: 0 - none; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of Participants|||Number
1223357|NCT00712244|Secondary|Percent Gain in Corneal Thickness.|Percent Gain in Corneal Thickness between the assessment performed before surgery to that performed after surgery. This was assessed at both the 1 week and 1 month visit. Corneal thickness is measured in micrometers and is evaluated by Pachymetry. A negative number indicates a decrease in corneal thickness.|1 week and month after surgery|Participants analyzed for Baseline to 1 week: 29 DisCovisc, 28 DuoVisc, 26 Healon5, 26 Amvisc Plus.|||Percent Gain||Standard Deviation|Mean
1223358|NCT00712244|Primary|Corneal Endothelial Cell Loss|Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope.|1 month after surgery||||Percent Change||Standard Deviation|Mean
1223359|NCT00712179|Primary|Diagnostic|"The electromyographic (EMG) gait pattern of stroke survivors was compared with normal pattern using z-scores."|During sessions- 1 day measurement|Individuals with chronic stroke.|||Z-score||Standard Error|Mean
1223360|NCT00712166|Secondary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF method was used.|||Percent change from baseline||Standard Error|Least Squares Mean
1223361|NCT00712166|Secondary|Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28|Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
1223362|NCT00712166|Other Pre-specified|The Minimum Concentrations of Aztreonam That Inhibit 50% and 90% of All PA Isolates (MIC50 and MIC90, Respectively)|Aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed. The minimum inhibitory concentration (MIC) is the lowest concentration of antimicrobial agent that inhibits visible growth of a microorganism. The MIC50 and MIC90 for PA is the MIC required to inhibit the growth of 50% or 90% of PA isolates, respectively. Given that there might be multiple PA isolates for each participant, the MIC50 and MIC90 for PA was calculated using the MIC values for all PA isolates. The MIC50 and MIC90 were calculated by treatment group.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo).|||µg/mL|||Number
1223363|NCT00712166|Other Pre-specified|Number of Participants Testing Positive for Other Respiratory Pathogens|Sputum/throat swab samples were collected at all visits for quantitative and qualitative culture of Burkholderia species, Stenotrophomonas maltophilia, Achromobacter xylosidans, methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), and Aspergillus species. One CFU on the culture from either a sputum or throat swab sample was considered presence of the particular organism.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Participants|||Number
1223364|NCT00712166|Secondary|Number of Participants Hospitalized During Study|Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Study participants|||Number
1223365|NCT00712166|Secondary|Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study|The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher’s Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Participants|||Number
1223366|NCT00712166|Secondary|Change From Baseline in CFQ-R Physical Functioning Domain Score|The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
1223367|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 42|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 42|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
1223368|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 14|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 14|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
1223369|NCT00712166|Primary|Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis on intent-to-treat (ITT) population (received at least part of 1 dose of AZLI/placebo). Missing baseline data not imputed. Missing post-baseline data imputed with worst-case value for participants who withdrew due to an adverse event (AE)/study drug intolerance. Imputation for other missing data was last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1223370|NCT00712075|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)||||units on a scale||Standard Deviation|Mean
1223901|NCT00709319|Secondary|Surgical Complications From Baseline to Six Months|Including intraoperative and perioperative medical complications. Same subject could have more than one complication|Baseline to 6 months||||Participants|||Number
1223371|NCT00712075|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)||||units on a scale||Standard Deviation|Mean
1223372|NCT00712075|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent a higher level of functioning.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|Due to incomplete ILSS data for one participant in the CBSST group, 25 of 26 participants were included in the analyses for this measure.|||units on a scale||Standard Deviation|Mean
1223373|NCT00712010|Primary|Calculation of the Area Under Curve Over Baseline for Plasma Insulin|The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes from baseline||||nmole/L*min||Standard Error|Mean
1223374|NCT00712010|Secondary|Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids||180 minutes|||||||
1223375|NCT00712010|Primary|Post-prandial Plasma Responses of Glucose Concentrations|The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes|23 subjects were investigated for AUC of glucose calculations|||mmole/L*min||Standard Error|Mean
1223376|NCT00711997|Primary|Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819|Number of Participants Reaching Maximal Tolerated Dose (MTD)|Week 4|All participants had to receive all 4 scheduled treatments and completed the Week 4 assessment|||participants|||Number
1223377|NCT00711997|Secondary|Tumor Resectability|The number of subjects in each cohort whose tumor was resectable at the end of the study was to be presented for the ITT and the per-protocol population.|5 to 6 weeks||||participants|||Number
1223378|NCT00711997|Secondary|Tumor Response|Tumor response and progression were defined in accordance with RECIST v. 1.0 and assessed by radiological examination 2 weeks after the end of treatment|4 weeks||||participants|||Number
1223379|NCT00711971|Other Pre-specified|Cord Arterial pH|Arterial blood gas analysis of umbilical cord blood|Immediately after birth (collected within the first hour after delivery)|Umbilical cord gases (pH) were sent at the discretion of the delivering physician and so were not available for all participants.|||pH||Standard Deviation|Mean
1223380|NCT00711971|Other Pre-specified|Five Minute Apgar Score|Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the five minute Apgar.|5 minutes after birth|One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.|||units on a scale||Standard Deviation|Mean
1223381|NCT00711971|Other Pre-specified|One Minute Apgar Score|Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the one minute Apgar.|1 minute after birth|One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.|||units on a scale||Standard Deviation|Mean
1223382|NCT00711971|Other Pre-specified|NICU (Neonatal Intensive Care Unit) Admissions|Admission to the NICU|6 weeks post delivery|One set of twins in group A|||Participants|||Count of Participants
1223383|NCT00711971|Other Pre-specified|Neonatal Birthweight|Mean weight in grams: where <2500 gm is considered small for gestational age and >4500 gm is considered large for gestational age.|immediately after birth|Data is provided for all babies on whom delivery weights were available with a set of twins in EPA rich fish oil arm and a delivery elsewhere for whom no birth weight was available for one baby from a mother in the Soy oil placebo arm. Thus there is 1 more participant than mothers participating in the EPA-rich arm and one less in the soy oil arm.|||grams||Standard Deviation|Mean
1223384|NCT00711971|Other Pre-specified|Estimated Blood Loss (ml)||Within 24 hours after delivery||||mL||Standard Deviation|Mean
1223385|NCT00711971|Other Pre-specified|Gestational Age at Delivery (Weeks)||delivery date was assessed by medical record review between 1 day and 8 weeks after delivery|Gestational age is measured based on the pregnancy not the neonates, therefore although there were 40 babies born to the 39 mothers randomized to the EPA-rich fish oil, it is proper to consider the participants analyzed to be the 39 participating mothers. This is clarified still further by identifying the units appropriately as pregnancies.|||weeks|pregnancies|Standard Deviation|Mean
1223386|NCT00711971|Other Pre-specified|Maternal Outcomes|While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery.|visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after delivery|"Gestational hypertension and diabetes were self-reported for all participants so her data is included for those two rows.~One woman in the soy placebo arm delivered out of the geographic area, so documentation of delivery outcome is unavailable for analysis."|||participants|||Number
1223387|NCT00711971|Primary|Beck Depression Inventory|The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)|6 - 8 weeks postpartum|Per protocol analysis is reported here.|||units on a scale||Standard Deviation|Mean
1223388|NCT00711958|Primary|Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia|Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.|5-12 weeks|Intention-to-treat population: patients with post baseline Hemoglobin value available|||Participants|||Count of Participants
1223389|NCT00711880|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
1223390|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment|"Subjects were asked to give their impression of the overall change in their allodynia since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’.~A summary of the number and percentage of subjects"|Day 0 - 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
1223391|NCT00711880|Secondary|Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment|Intoxication scores were measured using a 100 mm Visual Analogue Scale, where 0 equalled ‘no intoxication’ and 100 equalled ‘extreme intoxication’. A negative value indicates an improvement in intoxication score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223392|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment|Subjects were asked to give their impression of the overall change in their peripheral neuropathic pain since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’. The number of subjects who reported an improvement is presented.|Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
1223393|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||number of words||Standard Deviation|Mean
1223394|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||percentage of correct answers||Standard Deviation|Mean
1223395|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223396|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for ‘10/36 Spatial Recall' at the End of Treatment|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223397|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223398|NCT00711880|Secondary|Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment|The General Health Questionnaire-12 is designed to measure non-psychotic mental disorders. It consists of 12 questions, scored on a 0 to 3 Likert scale to measure and compare psychological morbidity levels, where 0 represents better psychological health. The total General Health Questionnaire-12 score is the unweighted sum of the 12 scores. Zero indicates the best possible psychological health, 36 indicates the worst possible psychological health.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223399|NCT00711880|Secondary|Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment|The static allodynia test involved applying pressure to a non-allodynic area (on the contralateral side to the identified allodynic area), and recording the pressure that caused pain to this area. Seventy five percent of the pressure that caused pain to the non-allodynic area (up to the subject’s pain/pressure threshold) was then applied to the allodynic area, and an 11-point Numerical Rating Scale pain score recorded (between 0 (no pain)and 10 (most intense pain imaginable)). A negative value indicates an improvement in pain score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223400|NCT00711880|Secondary|Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5sec intervals, and recording the pain severity on a 0–10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes. A negative change from baseline indicates an improvement in score.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223401|NCT00711880|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment|The Pain Disability Index consisted of seven self-administered questions relating to the effect of the subject’s chronic pain on their personal life (family/home responsibilities, social activity, sexual behaviour, life-support activity, recreation, occupation and self-care). Each assessment was scored on an 11-point Numerical Rating Scale ranging from 0 (which equals ‘no disability’) to 10 (which equals ‘total disability’). The total Pain Disability Index is the unweighted sum of the seven Numerical Rating Scale scores. The maximum (worst) total score was 70.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223402|NCT00711880|Secondary|Change From Baseline in Mean Sleep Quality at the End of Treatment|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223403|NCT00711880|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale (NPS) score consisted of a series of assessments of different aspects of pain (intensity, sharpness, hot, dull, cold, sensitive, itchy, unpleasantness, and surface compared with deep), each scored using 11-point Numerical Rating Scales. The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223404|NCT00711880|Primary|Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)|"The neuropathic pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = worst possible pain. A negative value indicates an improvement in pain score from baseline."|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1223405|NCT00711867|Primary|Sublingual Temperature.||Within 10 minutes of arrival in PACU|Per protocol.|||C||Standard Deviation|Mean
1223406|NCT00711828|Secondary|Adverse Events|Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.|up to 12 cycles (28 days per cycle) of treatment||||participants|||Number
1223407|NCT00711828|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
1223408|NCT00711828|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years from registration|Thirteen patients achieved a CR or a PR and are included in this analysis.|||months||95% Confidence Interval|Median
1223409|NCT00711828|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
1223410|NCT00711828|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
1223411|NCT00711828|Primary|Proportion of Responses (Complete Response or Partial Response)|A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.|up to 12 cycles||||percentage of participants||95% Confidence Interval|Number
1223412|NCT00711802|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])|"Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points:~Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion."|Predose and 5 timepoints according to age group (up to 12 hours postdose)|Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.|||microgram*hour per milliliter (μg*hr/mL)||Standard Deviation|Mean
1223413|NCT00711802|Secondary|Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit|"The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as Success or Failure by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered Success by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of “Failure” was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was “Failure.” If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was Unable to evaluate."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.|||percentage of participants|||Number
1223414|NCT00711802|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included possibly related or related as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.|||percentage of participants|||Number
1223415|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Legs|Ankle dorsiflexion, knee extension and hip flexion were assessed and scored to give a maximum of 100%. The Motricity Index score (scale 1-100) was recorded for limbs that had an associated Ashworth Scale score, which was greater than or equal to two at baseline.|Day 7 and Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223416|NCT00711646|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented.|Day 0-52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
1223417|NCT00711646|Secondary|Patient’s Global Impression of Change in Condition at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the change in your condition since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
1223418|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Arms|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. The total arm score was the addition of the score for the 3 arm movements. One point was then added to give a maximum score of 100; minimum was 1 point. Where both arms were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition..|Day 7 and 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223419|NCT00711646|Secondary|Change From Baseline in Mean Spasm Frequency Score at the End of Treatment|Each day subjects recorded in their diary the frequency of their spasms using the following scoring system: 0 = no spasms, 1 = one or fewer spasms per day, 2 = between one and five spasms per day, 3 = six to nine spasms per day, 4 = ten or more spasms per day or continuous contraction. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy.|Days 0 - 52||||units on a scale||Standard Deviation|Mean
1223420|NCT00711646|Secondary|Change From Baseline in Mean Ashworth Scale Score at the End of Treatment|The mean Ashworth Scale score across muscle groups was calculated using only those muscle groups with a score of greater than or equal to two at baseline. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Days 0 - 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223421|NCT00711646|Primary|Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.|"The spasticity Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your average spasticity in the last 24 hours where 0 = no spasticity and 10 = worst ever spasticity. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy. A negative value indicates an improvement in spasticity score from baseline."|0-52 days|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1223422|NCT00711594|Secondary|Phase I Step: Cmax,Cmax,ss of BIBW 2992 After Multiple Oral Administration||Just before start of the treatment to Course 4 Visit 4R2|"The “treated set” of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.Some samples were excluded from the evaluation because these were taken outside the allowed time-windows.~Number of analyzed patients of BIBW 50mg cohort for Cmax,ss: 5"|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1223423|NCT00711594|Secondary|Phase II Step: Summary of EGFR Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
1223424|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 15|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 15|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1223425|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 1|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 1|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1223426|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course1 Day 15|"Outcome data show the geometric mean (gMean) of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|Course 1 Day 15|Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification. No patient was treated with 30 mg during the Course 1.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1223427|NCT00711594|Secondary|Phase II Step: Maximum CTC Grade During the Trial for Laboratory Parameters, Among Patients Who Experienced an Increase in CTC Grade From Baseline|outcome data show the number of patients for the maximum CTC grade during the trial for laboratory parameters, among patients who experienced an increase in CTC Grade|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.~For activated partial thromboplastin time (APTT), N = 59 For Prothrombin Time and International Normalized Ratio (PT-INR), N = 61"|||participants|||Number
1223428|NCT00711594|Secondary|Phase II Step: Safety of BIBW 2992 as Indicated by Intensity and Incidence of Adverse Events, Graded According to CTCAE|outcome data show the number of patients with Adverse events (AE) by intensity and incidence of adverse events, graded according to CTCAE.|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
1223429|NCT00711594|Secondary|Phase II Step: Overall Survival (OS)|OS was defined as the duration of time from the start of treatment to the time of death.|from start of treatment until end of follow up, up to 53 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Months||Inter-Quartile Range|Median
1223430|NCT00711594|Secondary|Phase II Step: Progression-free Survival (PFS)|PFS was defined as the duration of time from the start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to the RECIST) or death.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Months||Inter-Quartile Range|Median
1223431|NCT00711594|Secondary|Phase II Step: Duration of Clinical Benefit|Presented as duration of disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Weeks||Full Range|Median
1223432|NCT00711594|Secondary|Phase I Step: Summary of Epidermal Growth Factor Receptor (EGFR) Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
1223501|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 6 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months||||μm||Full Range|Median
1223433|NCT00711594|Secondary|Phase II Step: Duration of Objective Response|Duration of objective response was defined as the time at which RECIST was first met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||weeks||Full Range|Median
1223434|NCT00711594|Secondary|Phase II Step: Time to Objective Response|Number of participants with first response at week 4, 8 and 12, assessed by investigator and independent review.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||Number of patients|||Number
1223435|NCT00711594|Secondary|Phase II Step: Clinical Benefit|Clinical benefit was defined as a RECIST assessment of complete response, partial response, or stable disease according to the best response to study treatment as defined in the previous section. Clinical benefit presented as the disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||percentage of participants||95% Confidence Interval|Number
1223436|NCT00711594|Secondary|Phase I Step: AUC0-24, AUCtau,ss of BIBW 2992 After Multiple Oral Administration|area under the concentration-time curve of BIBW 2992 over the time interval 0-24 hours (AUC0-24), Area under the concentration-time curve of Afatinib in plasma at steady state (AUCtau,ss) after multiple oral administration Pharmacokinetic was abbreviated to PK.|AUC0-24: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00 on Day 1-2 in Course 1; AUCtau,ss: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00, 48:00, 72:00 on Day 28-31 in Course 1|"“Treated set” was defined as all patients who received at least 1 dose of BIBW2992. Some samples were excluded from calculation of descriptive statistics of plasma concentration because these were taken outside the allowed time-windows but used for calculation of PK parameters.~Number of analyzed patients of BIBW 50mg:5(AUCtau,ss), 40mg:2(AUC0-24)"|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1223437|NCT00711594|Primary|Phase II Step: Objective Tumour Response According to Response Evaluation Criteria in Solid Tumours (RECIST)|The objective response (complete response [CR] and partial response [PR]) was defined as determined by the RECIST according to the best response to study treatment.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation), up to 41.3 months|"The full analysis set of patients was defined as all patients included in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||percentage of participants||95% Confidence Interval|Number
1223438|NCT00711594|Primary|Phase I Step: Safety of BIBW 2992 Assessed Based on Incidence of Dose Limiting Toxicity (DLT) and Incidence & Intensity of Adverse Events According to CTCAE||start of treatment to end of treatment|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
1223439|NCT00711555|Secondary|no Significant Nausea|defined as a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
1223440|NCT00711555|Secondary|no Nausea|defined as maximum nausea severity < 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
1223441|NCT00711555|Secondary|no Emesis||cycle 1, day 1||||%|||Number
1223442|NCT00711555|Secondary|Complete Protection|defined as no emesis, no use of rescue medications, and a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
1223443|NCT00711555|Primary|Complete Response|defined as a no emetic episodes and no use of rescue therapy|cycle 1, day 1||||%|||Number
1223444|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks.|Week 8||||units on a scale (HFRDIS)||Full Range|Median
1223445|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point.|Week 4||||units on a scale (HFRDIS)||Full Range|Median
1223446|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization).|Baseline||||units on a scale (HFRDIS)||Full Range|Median
1223447|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 8||||units on a scale (severity score)||Full Range|Median
1223448|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 4||||units on a scale (severity score)||Full Range|Median
1223449|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Baseline||||units on a scale (severity score)||Full Range|Median
1223450|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark."|Week 8||||daily hot flashes||Full Range|Median
1223451|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark."|Week 4||||daily hot flashes||Full Range|Median
1223452|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries."|Baseline||||daily hot flashes||Full Range|Median
1223453|NCT00711516|Secondary|Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test|During anatomic scanning (and prior to functional runs when anatomic scanning was not performed), a modified continuous 10 minute attention task (“Psychomotor Vigilance Test [PVT]-like task,” nearly identical to the PVT but for absence of performance feedback) was run to obtain a measure of vigilance in the scanner—in this instance, the “+” symbol appeared at random (mean inter trial interval of 5 seconds, range 2 - 10 seconds) but disappeared when subject pressed a button. Subject performance speed was measured. Change in subject performance speed from Baseline to Endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline|||milliseconds (ms)||Standard Error|Least Squares Mean
1223454|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the thalamus.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
1223902|NCT00709319|Primary|Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline|Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.|Baseline to 6 Months||||microns||Inter-Quartile Range|Median
1223455|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
1223456|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels meeting pre-defined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
1223457|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the dorsolateral prefrontal cortex.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline|||Voxels||Full Range|Median
1223458|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the thalamus.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline|||BOLD signal intensity||Full Range|Median
1223459|NCT00711516|Secondary|Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline|||BOLD signal intensity||Full Range|Median
1223460|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent signal (BOLD) intensity in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline|||BOLD signal intensity||Full Range|Median
1223461|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the dorsolateral prefrontal cortex (DLPFC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline|||BOLD signal intensity||Full Range|Median
1223462|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the thalamus for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
1223463|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the posterior parietal cortex (PPC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
1223464|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the anterior cingulate cortex (ACC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
1223473|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI over DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1223465|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the dorsolateral prefrontal cortex (DLPFC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis among non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
1223466|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (voxels that differ significantly from reference wave form) in the thalamus. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
1223467|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels (voxels that differ significantly from reference wave form) in Posterior Parietal Cortex (PPC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had a response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
1223468|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (that differ significantly from reference wave form) in Anterior Cingulate Cortex (ACC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
1223469|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels meeting the predefined threshold in DLPFC. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels (that differ significantly from reference wave form) for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test defined as subjects who had a response latency of < 713 ms at Endpoint|||Activated voxels||Standard Error|Mean
1223470|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between BOLD signal intensity on fMRI in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1223471|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1223472|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in the ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1223502|NCT00711490|Secondary|Change in Visual Acuity From Baseline to 12 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|12 months||||ETDRS letters||Full Range|Median
1223474|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1223475|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1223476|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline|||Correlation Coefficient|||Number
1223477|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1223478|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent change in BOLD signal||Full Range|Median
1223479|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent change in Bold signal||Full Range|Median
1223480|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline|||Percent change in BOLD signal||Full Range|Median
1223481|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Percentage change in BOLD signal||Full Range|Median
1223490|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in any 1 of 5 locations in the 5 choice reaction time phase. The change from baseline to endpoint in median correct latency is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Full Range|Median
1223482|NCT00711516|Secondary|Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint|The MOS-CF6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6 item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 was scored by summing responses across the 6 items and converting the total to a 0 to 100 point scale, with higher scores indicating better cognitive functioning. Change in MOS-CF6 from baseline to endpoint is reported.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Population defined as subjects who had at least one efficacy evaluation after baseline.|||Units on a scale||Standard Error|Least Squares Mean
1223483|NCT00711516|Secondary|Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint|Severity of sleepiness, was assessed by the Clinical Global Impression of Severity (CGI-S) at Baseline. The clinician assessed the change from baseline in the patient’s condition, as related to excessive sleepiness, in response to treatment using the CGI-C, which consisted of the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders had to be at least minimally improved from Baseline to qualify as a responder at Endpoint.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Participants|||Number
1223484|NCT00711516|Secondary|Epworth Sleepiness Scale Change From Baseline to Endpoint|The patient’s evaluation of excessive daytime sleepiness was measured by the patient reported measure, ESS (Johns1991). The ESS score was based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflected a patient’s propensity to fall asleep in those situations. The ESS score was derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS ranged from 0 to 24, with a higher score indicating a greater daytime sleepiness. Change from baseline to endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full analysis set defined as subjects who had at least one efficacy evaluation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1223485|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient had to work out how many moves the solutions required in their heads. Mean change from baseline to endpoint in number of choices to correct for hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Choices to correct||Standard Deviation|Mean
1223486|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient is shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient has to work out how many moves the solutions required in their heads. Mean change from Baseline to endpoint in number of choices to correct for easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy measure after baseline|||Choices to correct||Standard Deviation|Mean
1223487|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Standard Deviation|Mean
1223488|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Milliseconds (ms)||Standard Deviation|Mean
1223489|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in a single location during the simple reaction time phase. The change from baseline to endpoint in median correct latency is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Full Range|Median
1223957|NCT00709098|Other Pre-specified|Average Inhalation Time|Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)|12 weeks|All treated population|||minutes||Standard Deviation|Mean
1223491|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint|"The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory as measured by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Twenty minutes following the immediate recognition test, another delayed recognition test is performed, featuring the same stimuli as in the first phase. The change from baseline to endpoint in percent correct responses of this delayed test are presented here. Subjects complete 24 trials per assessment."|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent correct trials|Participants|Standard Deviation|Mean
1223492|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint|The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Immediately afterwards a recognition test is performed, in which each pattern shown earlier is presented with another pattern of similar form and color. Patient has to touch the pattern seen earlier. Change from baseline to endpoint in % correct responses with immediate recall is presented. Subjects complete 24 trials per assessment.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent correct trials|Participants|Standard Deviation|Mean
1223493|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus|The outcome was the change from baseline in number of contiguous activated voxels in the thalamus on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value significantly (p<0.05), the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set|||Activated voxels||Standard Error|Mean
1223494|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)|The outcome was the change from baseline in number of contiguous activated voxels in the posterior parietal cortex (PPC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value with p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Activated voxels||Standard Deviation|Mean
1223495|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)|The outcome was the change from baseline in number of contiguous activated voxels in the anterior cingulate cortex (ACC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Activated Voxels||Standard Deviation|Mean
1223496|NCT00711516|Secondary|Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed|The 2-Back is a verbal working memory test in which random letters are presented visually every 4 sec, with each stimulus lasting 500 msec. Subjects are asked to make a yes/no response following each letter indicating whether it was the same or different from the letter presented two earlier. The load on working memory was the ordering, retention, updating, and manipulation of 2 letters and consideration of the relationship to a 3rd newly presented letter, which could have been a target or a nontarget. The change from baseline in response latency at endpoint is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Milliseconds (ms)||Standard Deviation|Mean
1223497|NCT00711516|Primary|Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation|The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Efficacy analyses were performed on the full analysis dataset which includes those patients in the safety analysis set who had at least 1 post baseline primary efficacy assessment.|||Activated voxels||Standard Deviation|Mean
1223498|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 12 Months, as Measured on Fluorescein Angiography (FA)||12 months|||||||
1223499|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 6 Months, as Measured on Fluorescein Angiography (FA)||6 months|||||||
1223500|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 12 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|12 months||||μm||Full Range|Median
1223503|NCT00711490|Primary|Change in Visual Acuity From Baseline to 6 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months||||ETDRS letters||Full Range|Median
1223504|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Posterior Insula|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1223505|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Parietal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1223506|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 2|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1223507|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 1|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1223508|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Anterior Cingulate|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1223509|NCT00711477|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1223510|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in External Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The External Eating subscale consisted of 10 items and the scores ranged from 10 (better outcome) to 50 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1223511|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating B Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating B subscale (diffuse emotions) consisted of 4 items and the scores ranged from 4 (better outcome) to 20 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1223512|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating A Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating A subscale (clearly labeled emotions) consisted of 9 items and the scores ranged from 9 (better outcome) to 45 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1223513|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Restrained Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Restrained Eating subscale consisted of 10 items and the scores ranged from 10 (worse outcome) to 50 (better outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1223514|NCT00711477|Secondary|Percent Change in Body Weight||Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percentage of body weight||Standard Error|Least Squares Mean
1224466|NCT00706641|Secondary|Reduced pSFK Expression|pSFK levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
1223515|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Frontal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1223516|NCT00711464|Secondary|Heart Rate|beats per minute|3-5 hours||||beats per minute||Standard Deviation|Mean
1223517|NCT00711464|Secondary|Systolic Blood Pressure|systolic blood pressure in mm Hg|3-5 hours||||mm Hg||Standard Deviation|Mean
1223518|NCT00711464|Primary|Cognitive Performance|Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control|3-5 hours||||percentage correct of all trials||Standard Deviation|Mean
1223519|NCT00711425|Primary|Marginal Bone Adaptation|Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis.|||Millimeter|Participants|Standard Deviation|Mean
1223520|NCT00711425|Primary|Implant Stability|Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis.|||ISQ|Participants|Standard Deviation|Mean
1223521|NCT00711425|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).|||Percentage of implants|Participants||Number
1223522|NCT00711412|Post-Hoc|Overall Survival||From the start of treatment and then every 3 months until death or a maximum of 24 months.|1 patient was registered to the study, but was not treated on study and was therefore not evaluable. Data for overall surivival was collected at 3 months, 6 months, 12 months and 24 months. There was no further data analysis completed|||percentage of patients alive|||Number
1223523|NCT00711412|Post-Hoc|Determine Progressive Free Survival||After cycles 2, and 4 (pre-surgery) 30 days after surgery and then every 3 months until first documentation of progressive disease, death and up to a maximum of 24 months.|The only data collected for this outcome measure was progression free survival rate at 3 months, 6 months, and 12 months.|||percentage of patents progression free|||Number
1223524|NCT00711412|Secondary|Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy.||At time of sugery|No data was collected for this outcome measure. There is no data to report on.||||||
1223525|NCT00711412|Secondary|Toxicity Profile|"Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0)~In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~Only incidents of AEs determined to be related to chemotherapy are recorded here."|During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.|Toxicity data was collected and analysed for the first 40 patients.|||participants|||Number
1223526|NCT00711412|Secondary|Patterns of Failure||At time of surgery|No data collected for this outcome measure. There is no data to report on.||||||
1223527|NCT00711412|Secondary|Time to Progression|Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact.|From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.|Data collected was not analyzed before the study was terminated. Count of participants indicates the number of patients with progressive disease or death at the time the study closed permanently.|||Participants|||Count of Participants
1223528|NCT00711412|Secondary|Recurrence Rate|Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study.|From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.|1 patient was registered but not treated on study and therefore was not evaluable.|||Participants|||Count of Participants
1223529|NCT00711412|Secondary|Clinical Response Rate|"Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) .~Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD"|four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery|1 patient was registered to the study but was not treated on study and was therefore not evaluable.|||Participants|||Count of Participants
1223530|NCT00711412|Primary|Determine Pathologic Complete Response|"Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections.~Pathologic response will be defined as:~P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer"|At time of surgery|Patients analyzed were patients that reached and completed surgery.|||Participants|||Count of Participants
1223531|NCT00711347|Secondary|Surgeon Survey|"Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported:~Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult~Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree~Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective"|Time of Surgery||||Units on a scale||Standard Deviation|Mean
1223532|NCT00711347|Secondary|Aqueous Signs - Edema|"Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale:~0 = none~= mild - slight localized or generalized edema~= moderate - significant localized or generalized edema~= severe - advanced localized or generalized edema"|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
1223533|NCT00711347|Secondary|Aqueous Signs - Flare|"Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale:~0:No-Visible flare when compared with the normal eye.~Mild-Flare visible against dark papillary background but not visible against iris background.~Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.~Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
1223534|NCT00711347|Secondary|Aqueous Signs - Cells|Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
1223535|NCT00711347|Secondary|Intraocular Pressure (IOP)|Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.|1 Day Postoperative|14 patients/28 eyes in each group.|||mmHg||Standard Deviation|Mean
1223536|NCT00711347|Primary|Corneal Endothelial Cell Loss|Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.|1 month|14 patients/28 eyes in each group.|||Percent change||Standard Deviation|Mean
1223537|NCT00711269|Secondary|Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)|Proportion of participants with treatment-emergent adverse events. An adverse event was considered serious if it met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Was considered to be an important medical event.|From Baseline to up to 8 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.|||Participants|||Count of Participants
1223538|NCT00711269|Secondary|Proportion of Participants With TEAEs Leading to Discontinuation||From Baseline to up to 8 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.|||Participants|||Count of Participants
1223539|NCT00711269|Secondary|Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)|Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a study participant who was taking a medicinal (investigational) product. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a start date on or after the date of the first dose through the end of follow-up, or adverse events occurring before the date of first dose and worsening during the treatment or follow-up period.|From Baseline to up to 8 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.|||Participants|||Count of Participants
1223540|NCT00711269|Secondary|Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)|The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity.|Baseline and Week 6 (LOCF)|FAS (Full Analysis Set)|||units on a scale||Standard Deviation|Least Squares Mean
1223541|NCT00711269|Secondary|Change From Baseline in the PANSS Negative Subscales at Week 6|The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Baseline and Week 6 (LOCF)|FAS (Full Analysis Set)|||units on a scale||Standard Deviation|Least Squares Mean
1223542|NCT00711269|Secondary|Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)|The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Baseline and Week 6 (LOCF)|FAS (Full Analysis Set)|||units on a scale||Standard Deviation|Least Squares Mean
1247065|NCT00530842|Secondary|Static Lung Volumes|Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1223543|NCT00711269|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline and Week 6 [Last Observation Carried Forward (LOCF)]|FAS (Full Analysis Set)|||units on a scale||Standard Deviation|Least Squares Mean
1223544|NCT00711243|Post-Hoc|Median Overall Survival (OS)|Median Overall Survival (OS)|From first day of treatment until death from any cause measured, assessed up to 4 years|Patients enrolled in phase II portion of the study were evaluable for OS. One patient in phase II was registered to the study but did not receive treatment and was not evaluable for OS. Two patients did not have death dates and were censored for the last known time to be living.|||Months||95% Confidence Interval|Median
1223545|NCT00711243|Secondary|Toxicity Profile|"Toxicity data will be collected on day 1 of every 14 day cycle during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events (AE) version 3.0 (CTCAE v3.0). For patients that experience multiple grades of the same AE that is determined to be at least possibly related to at least one study drug, only highest grade will be collected. In general AEs will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Day 1 of each cycle of therapy with 1 cycle =14 days until disease progression for up to a maximum of 34 cycles and 30 days after last treatment|Data collected and analyzed for patients enrolled in the phase II of the study only.1 Patient did not receive treatment on study and was not evaluable. For each patient that experienced the toxicity, highest grade for that patient is recorded. Grades ranging between 1-5 were collected and are represented below.|||participants|||Number
1223546|NCT00711243|Secondary|Frequency of DPD and TSER Polymorphisms and Their Impact on Fluorouracil Toxicity||Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle|Data not collected.||||||
1223547|NCT00711243|Secondary|Frequency of XRCC1 and ERCC2 Polymorphisms and Their Impact on Oxaliplatin Toxicity||Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle|Data not collected.||||||
1223548|NCT00711243|Secondary|Frequency of CYP3A4, CYP3A5, and MDR Polymorphisms and Their Impact on Docetaxel Toxicity||Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle|Data not collected.||||||
1223549|NCT00711243|Secondary|Dose-limiting Toxicity of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil|"Dose limiting toxicities (DLT) will be graded according to National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) except for neurosensory. The occurrence of any of the following during the 1st cycle, seen in more than one patient, will constitute a DLT.~Grade 3 non-hematologic toxicity(except alopecia) Grade 4 thrombocytopenia, not recovered to platelet count of >75,000/ul by day 15.~Grade 4 neutropenia, not recovered to count of >1,500/ul by day 15. Grade 4 neutropenia with fever or infection. Grade 2 neurologic-sensory toxicity not recovered to grade 1 or better by day 15"|After 1 cycle of therapy (1 cycle = 14 days)|15 patients enrolled in 5 dose escalating cohorts were monitored for DLTs in the phase I part of the study.|||participants|||Number
1223550|NCT00711243|Primary|Response Rate in Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction (Phase II)|"Overall Response Rate (ORR) is defined as Complete Response (CR) plus Partial Response (PR) and will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan.~Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum.~Stable Disease, neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study.~Progressive Disease - <=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|After 4 cycles of therapy (1 cycle = 14 days)|One patient that was registered to phase II did not get treated on study and was therefore not evaluable. Two patients did not reach first response at 4 cycles and therefore were not evaluable.|||percentage of patients|||Number
1223551|NCT00711243|Primary|Maximum Tolerated Dose (MTD) of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil (Phase I)|"The MTD will be determined using a 3+3 dose escalating design. There will be 5 dose cohorts:~Cohort 1a 25mg/m2 Cohort 2a 30mg/m2 Cohort 3a 40 mg/m2 Cohort 4a 50 mg/m2 Cohort 5a 60 mg/m2~3 patients will be enrolled at dose of 25mg/m2 docetaxel. If no dose limiting toxicities (DLTs) are seen then dose will be escalated to next cohort and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. Dose of docetaxel will be escalated by use of cohorts until the MTD for phase II is determined.~DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0"|After completion of 1 cycle of therapy (1 cycle = 14 days)|Dose of docetaxel was escalated up through 5 cohorts.|||mg/m2|||Number
1223552|NCT00711191|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer|Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing. RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1.|Baseline up to time of determination of maximum tolerated dose (MTD)|Safety population|||mg/kg|||Number
1223553|NCT00711191|Secondary|Carbohydrate Antigen 19-9 (CA 19-9)|CA 19-9 or sialylated Lewis (a) antigen (a tumor marker). Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease.|At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223554|NCT00711191|Secondary|18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort)|FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV). A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment.|Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223555|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR)|Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies. Change calculated as mean of pre-dose and post-dose values. Positive values indicate greater presence of cells associated with antibody production.|Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223556|NCT00711191|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223557|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223558|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223559|NCT00711191|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast analyzed using a noncompartmental approach to estimate individual participant values.|Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223560|NCT00711191|Secondary|Maximum Serum Concentration (Cmax)||Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223561|NCT00711191|Secondary|Time to Progression|Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Criteria for progression also included unequivocal progression of existing nontarget lesions.|Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1223562|NCT00711191|Secondary|Progression Free Survival (PFS)|PFS is time from baseline to first progression (Prog) or death from any cause. Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog. Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored. Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95% CI for 50% quartile based on Brookmeyer and Crowley Method. Criteria for progression also included unequivocal progression of existing nontarget lesions.|||months||95% Confidence Interval|Median
1223563|NCT00711191|Secondary|Overall Survival (OS)|OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95 percent confidence interval (95% CI) for 50% quartile based on Brookmeyer and Crowley Method.|||months||95% Confidence Interval|Median
1223564|NCT00711191|Secondary|Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response|Safety population; Confidence Interval (CI) calculated using exact method based on binomial distribution.|||percentage of participants||95% Confidence Interval|Number
1223579|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223565|NCT00711191|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|"Any of the following during first cycle of treatment and attributable to CP-870893:~afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia)."|Baseline up to Cycle 1 / Day 28|Safety population: all participants who received any study treatment. Cubic millimeters (mm^3).|||participants|||Number
1223566|NCT00711113|Primary|Marginal Bone Adaptation|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At baseline (loading) and at 5 year follow-up|Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis.|||Millimeter|Participants|Standard Deviation|Mean
1223567|NCT00711113|Primary|Implant Stability|Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis.|||units on a scale|Participants|Standard Deviation|Mean
1223568|NCT00711113|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period.|||percentage of implants|Participants||Number
1223569|NCT00711100|Primary|Abstinence From Cigarettes|Abstinence from cigarettes during Abstinence Phase.|Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)|At the end of Sampling Phase, subjects chose a preferred product to use during a two week Abstinence Phase. Abstinence from cigarettes was determined during the 2 week study product phase (e.g., Abstinence Phase) and 1 week after this phase.|||Participants|||Count of Participants
1223570|NCT00711100|Primary|Product Preference|Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).|2 weeks||||participants|||Number
1223571|NCT00711087|Primary|A Change in DLPP of 20cm H2O at Day 30 and Day 120 in the BTX-A Injected Group (Group 1) Compared to the Sham Saline Injected Group (Group 2).|This outcome measure was not able to be determined due to the subject being lost to follow-up. The subject no longer returns phone calls or visits the clinic.|2.5 years|Early spinal cord injury||||||
1223572|NCT00711022|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5-year follow-up|Per protocol analysis presented, this includes implants loaded within 24 hours from implant placement (306 implants in 51 subjects), of these 20 implants failed during the 5 year follow-up period.|||percentage of implants|Participants||Number
1223573|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams/cm^2||Standard Deviation|Mean
1223574|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223575|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223576|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223577|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223578|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223580|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223581|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223582|NCT00711009|Secondary|Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223583|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223584|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223585|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223586|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1223587|NCT00711009|Secondary|Mean Change From Baseline in Mid-Thigh Measurement (cm)|Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant’s thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
1223588|NCT00711009|Secondary|Mean Change From Baseline in Hips Measurement (cm)|Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
1223589|NCT00711009|Secondary|Mean Change From Baseline in Mid-Arm Measurement (cm)|Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant’s arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
1223590|NCT00711009|Secondary|Mean Change From Baseline in Waist Measurement (cm)|Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant’s waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
1223591|NCT00711009|Secondary|Mean Change From Baseline in Chest Measurement (cm)|Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant’s chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||cm||Standard Deviation|Mean
1223592|NCT00711009|Secondary|Mean Change From Baseline in Temperature (°F)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||°F||Standard Deviation|Mean
1223593|NCT00711009|Secondary|Mean Change From Baseline in Weight (kg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||kg||Standard Deviation|Mean
1223594|NCT00711009|Secondary|Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||beats per minute||Standard Deviation|Mean
1223595|NCT00711009|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||mm Hg||Standard Deviation|Mean
1223598|NCT00711009|Secondary|Mean Change From Baseline in Urine Specific Gravity|Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||ratio of urine density to water density||Standard Deviation|Mean
1223599|NCT00711009|Secondary|Mean Change From Baseline in Insulin (Picomoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picomoles/liter||Standard Deviation|Mean
1223600|NCT00711009|Secondary|Mean Change From Baseline in Leptin (Nanograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||nanograms/milliliter||Standard Deviation|Mean
1223601|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picograms/milliliter||Standard Deviation|Mean
1223602|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picograms/milliliter||Standard Deviation|Mean
1223603|NCT00711009|Secondary|Mean Change From Baseline in Lactate (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
1223604|NCT00711009|Secondary|Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||nanograms/liter||Standard Deviation|Mean
1223605|NCT00711009|Secondary|Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micrograms/milliliter||Standard Deviation|Mean
1223606|NCT00711009|Secondary|Mean Change From Baseline in Magnesium (Millimoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
1223607|NCT00711009|Secondary|Mean Change From Baseline in Lipase (Units/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1223608|NCT00711009|Secondary|Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1223609|NCT00711009|Secondary|Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
1223610|NCT00711009|Secondary|Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||milliliters/second||Standard Deviation|Mean
1223611|NCT00711009|Secondary|Mean Change From Baseline in Triglycerides (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223612|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)||Baseline to Week 96|Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.|||ratio||Standard Deviation|Mean
1223613|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223614|NCT00711009|Secondary|Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223615|NCT00711009|Secondary|Mean Change From Baseline in Cholesterol (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223616|NCT00711009|Secondary|Mean Change From Baseline in Total Protein (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
1223617|NCT00711009|Secondary|Mean Change From Baseline in Albumin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
1223618|NCT00711009|Secondary|Mean Change From Baseline in Bicarbonate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223619|NCT00711009|Secondary|Mean Change From Baseline in Chloride (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223620|NCT00711009|Secondary|Mean Change From Baseline in Potassium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223621|NCT00711009|Secondary|Mean Change From Baseline in Sodium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223622|NCT00711009|Secondary|Mean Change From Baseline in Calcium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223623|NCT00711009|Secondary|Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1223640|NCT00711009|Secondary|Mean Change From Baseline in Hematocrit (Fraction)|Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||% by volume of packed RBCs in blood||Standard Deviation|Mean
1223641|NCT00711009|Secondary|Mean Change From Baseline in Hemoglobin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
1223642|NCT00711009|Secondary|Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication|The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1223643|NCT00711009|Secondary|Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication|The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1223644|NCT00711009|Secondary|Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)|The Effectiveness Scale of the TSQM evaluates the participant’s satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1223645|NCT00711009|Secondary|Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||Scores on a scale||Standard Error|Mean
1223646|NCT00711009|Secondary|Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||Scores on a scale||Standard Error|Mean
1223647|NCT00711009|Secondary|Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir|Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/mL to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.|||Participants|||Number
1223648|NCT00711009|Secondary|Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.|Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/ml to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.|||Participants|||Number
1223649|NCT00711009|Secondary|Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672|Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.|Baseline to Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1223650|NCT00711009|Secondary|Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit||Baseline to Week 96|Participants who had values at Baseline and the visit were included in the analysis of data at that visit. Number of participants in each visit analysis ranged from 98 and 96 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 8, to 80 and 76 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 96.|||cells/microliter||Standard Error|Mean
1223651|NCT00711009|Primary|Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values|Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.|Baseline to Week 96|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.|||Percentage of participants|||Number
1223652|NCT00711009|Secondary|Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 96|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1223653|NCT00711009|Primary|Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.|Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1223654|NCT00711009|Primary|Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 48|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1223655|NCT00710996|Primary|Photostress Recovery Time in Seconds.|The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.|3 months||||seconds||Standard Deviation|Mean
1223656|NCT00710970|Primary|Sustained Stable Disease is Considered to be Clinically Important. Hence, 4-month Freedom From Progression (FFP) (Stable Disease + Partial Response + Complete Response) is Chosen as the Primary End-point Instead of Response Rate.||4 months||||participants|||Number
1223657|NCT00710970|Primary|Tamoxifen : Tamoxifen is Administered at 20 mg/Day as a Single Daily Oral Dose. Tamoxifen is Continued Until Progressive Disease or Intolerable Grade 3 or 4 Side Effects Occur Due to Tamoxifen.||To progression|||||||
1223658|NCT00710944|Primary|Implant Survival|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|12 months after implant placement|Per protocol analysis presented, this includes implants immediately loaded (Group A: 55 implants in 55 subjects, Group B: 58 implants in 58 subjects, Group C: 19 implants in 19 subjects), of these 5 implants in total failed within 12 months after implant placement.|||percentage of implants|Participants||Number
1223659|NCT00710931|Primary|Binocular Visual Acuity at Distance, Near and Intermediate|Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after surgery||||LogMAR||Standard Deviation|Mean
1223660|NCT00710905|Primary|Binocular Visual Acuity at Near, Intermediate and Distance|Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after surgery||||LogMAR||Standard Deviation|Mean
1223661|NCT00710879|Secondary|Solution Utlility|The Utility was determined based on the results of the efficacy and safety evaluations.|3 months, 6 months|All Eligible, Dispensed Eyes|||Eyes|Participants||Number
1223662|NCT00710879|Secondary|Solution Related AE's and Lens Changes|Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.|3 months, 6 months|All Eligible, Dispensed Eyes|||Eyes|Participants||Number
1223683|NCT00710749|Primary|Mean Urine Flow Rate|Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow.|At every voiding event during approximately one week.|Intention to treat analysis. Number of participants analyzed differs between groups since data was missing mainly due to technical problems.|||ml/s||Standard Deviation|Mean
1223663|NCT00710879|Primary|Antimicrobial Efficacy|Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae|2 weeks, 3 months|All eligible, dispensed eyes with cultures taken within window. Group I subjects were cultured at the 3-Month Visit. Group IV subjects were cultured at the 2-week Follow-up visit.|||Eyes|Participants||Number
1223664|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol|||participants|||Number
1223665|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Infants 6-11 Months|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol|||participants|||Number
1223666|NCT00710866|Primary|Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1223667|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)||27-46 days after the second dose|Per Protocol|||participants|||Number
1223668|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1223669|NCT00710866|Primary|Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1223670|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1223671|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1223672|NCT00710840|Secondary|Functional Performance: Stair Climb Test|This outcome measures the time (seconds) it takes to climb up and back down 12 steps.|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Seconds||Standard Deviation|Mean
1223673|NCT00710840|Primary|Knee Range of Motion|Knee Flexion Active Range of Motion (AROM)|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||degrees||Standard Deviation|Mean
1223674|NCT00710840|Secondary|Functional Performance: 6 Minute Walk (6MW) Distance||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Meters||Standard Deviation|Mean
1223675|NCT00710840|Primary|Quadriceps Muscle Force||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Nm/kg||Standard Deviation|Mean
1223676|NCT00710814|Primary|Weight Change (in kg.) After Each Intervention|"For the Leptin Intervention, 16 week values were compared to baseline for those who received Leptin in the first period, and 32 week values were compared to 16 week values in those who received Leptin in the second period.~For the Placebo Intervention, 16 week values were compared to baseline for those who received Placebo in the first period, and 32 week values were compared to 16 week values in those who received Placebo in the second period."|0 weeks, 16 weeks and 32 weeks||||kg weight change||95% Confidence Interval|Mean
1223677|NCT00710762|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters|Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|First drug administration until 28 days after last drug administration, up until 309 days|Treated set|||Percentage of participants|||Number
1223678|NCT00710762|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First drug administration until 28 days after last drug administration,up until 309 days|Treated set|||percentage of participants|||Number
1223679|NCT00710762|Secondary|Time to Death|This end point was not determined as no patients died during the trial.|9 months|This endpoint could not be calculated as no patients died.||||||
1223680|NCT00710762|Secondary|Time to Tumour Progression|"Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.~For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:~Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.~Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD."|9 months|Treated set|||days||95% Confidence Interval|Median
1223681|NCT00710762|Secondary|PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)|The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|12 weeks (after 3 months) and 24 weeks ( after 6 months)|Treated set|||percent probability of PFS||95% Confidence Interval|Number
1223682|NCT00710762|Primary|PFS Rate at 36 Weeks (After 9 Months)|The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|36 weeks (after 9 months)|Treated set.|||percent probability of PFS||95% Confidence Interval|Number
1223684|NCT00710684|Secondary|Change From Baseline in RBANS Scale in Participants With APOE4 Gene|Genetic analyses was conducted to assess the effect of APOE4 carriage. RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
1223685|NCT00710684|Secondary|Change From Baseline in CDR-SB Scale in Participants With APOE4 Gene|Genetic analyses was conducted to assess the effect of APOE4 carriage. The CDR-SB is an interviewer administered scale and impairment is scored in following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment was scored on a scale in which none =0, questionable =0.5, mild =1, moderate =2 and severe =3. The 6 individual category ratings, or “box scores”, were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher score indicating severe impairment. If there were any missing items then CDR-SB was set to missing and was not imputed. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
1223686|NCT00710684|Secondary|Change From Baseline in ADAS-Cog Scale in Participants With APOE4 Gene|Genetic analyses was conducted to assess the effect of APOE4 carriage. ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five-point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores were recorded on the CRF for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population consisted of all participants in the ITT population who had evaluable PGx data. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
1223687|NCT00710684|Secondary|Exposure Estimates for Donepezil (Cavgss)|Participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) were allowed to participate in this study. Cavgss for donepezil approximately 12 to 20 hours after dosing were summarized by donepezil dose level 5 mg/7.5 mg/10 mg/15 mg.|Post-dose at 12 to 20 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|Donepezil PK population comprised of participants who received a stable dose of donepezil 5 mg/7.5 mg/10 mg/15 mg. Analysis is exclusively for Cavgss of donepezil therefore the two arms SB-742457 15 mg and SB-742457 35 mg have not been presented.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1223688|NCT00710684|Secondary|Exposure Estimates for SB-742457 : Minimum Concentrations at Steady State (Cmin-ss)|Cmin-ss was estimated via nonlinear mixed effect analysis. This PK model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.|Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1223689|NCT00710684|Secondary|Exposure Estimates for SB-742457 : Area Under the Concentration Time Curve Over the Dosing Interval at Steady State (AUCτss)|AUCτss of SB-742457 was estimated via nonlinear mixed effect analysis. This pharmacokinetic(PK) model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.|Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|PK population included all participants for whom a pharmacokinetic sample was obtained and analyzed.|||Nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1223690|NCT00710684|Secondary|Number of Participants With Parameters of Clinical Concern - Clinical Chemistry|Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Alanine Amino Transferase (ALT) (high-1.5), Alkaline Phosphatase (high-1.5), Aspartate Amino Transferase (ASAT) (high-1.5), BUN/Creatinine ratio (high-1.5), Calcium (low- 0.75, high-1.25), Carbon dioxide content/Bicarbonate (low-15, high- 40), Cholesterol (high-1.25), Creatine Kinase ((low- 0.5, high-1.25), Creatinine (low- 0.5, high-1.25), Direct Bilirubin (high-1.5), Gamma Glutamyl Transferase (GGT) (high-2), Glucose (low- 3.6, high-7.8), HDL Cholesterol (low-0.65), LDL Cholesterol (hig-1.25), Magnesium (low-0.5, high-2), Phosphorus inorganic (low- 0.5, high-1.5), Potassium (low- 3, high-5.5), Sodium (low- 130, high-150), Total Bilirubin (high-1.5), Triglycerides (high -4) and Urea/BUN (high-11).|Up to Week 48|Safety population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
1223691|NCT00710684|Secondary|Number of Participants With Parameters of Clinical Concern - Hematology|Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Eosinophils (high-2), Hematocrit (low- 0.8, high-1.2), Lymphocytes (low-0.75, high-1.5), Mean Corpuscle Hemoglobin (MCH) (low-0.8, high-1.2), Monocytes(low-0.75, high-2), Neutrophil bands (high-10), Platelet count (low-100, high-500), Segmented Neutrophils (low-0.75, high-1.3), Total Neutrophils (low-0.75, high-1.5), and white blood cells (WBC) (low-3, high-15).|Up to Week 48|Safety population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
1223710|NCT00710593|Secondary|Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
1223711|NCT00710593|Secondary|Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
1223692|NCT00710684|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During Treatment Phase|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to follow-up i.e. 2 weeks post end of treatment (Week 24, Week 48 or Early Withdrawal)|Safety population consisted of all participants randomized to treatment who had received at least one dose of study medication.|||Participants|||Count of Participants
1223693|NCT00710684|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 24 and 48|The MMSE consisted of 11 items covering orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Scores for each of the 11 individual tests were not recorded on the CRF, therefore if any item was missing then the total score was be set to missing. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 24 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1223694|NCT00710684|Secondary|Change From Baseline in Alzheimer’s Disease Co-operative Study Group – Activities of Daily Living Inventory (ADCS- ADL) Total Score at Weeks 12, 24, 36 and 48|The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions about the participant. The questions ranged from basic to instrumental activities of daily living and take approximately 20 minutes to complete. The Total score ranges from 0-78 and a higher score signified greater functional ability. The questionnaire was split into two types of questions, an initial question relating to whether a participant had completed a particular activity and then a follow on question which scored how much assistance the participant had required if they had performed that particular activity. The total score was calculated by adding up the responses for each of the individual activities. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 12, 24, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1223695|NCT00710684|Secondary|Change From Baseline in RBANS Score at Week 12, 36 and 48|RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 12, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1223696|NCT00710684|Secondary|Change From Baseline in CDR-SB Score at Week 12, 36 and 48|The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or “box scores”, were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1223697|NCT00710684|Secondary|Change From Baseline in ADAS-Cog Total Score at Week 12, 36 and 48|ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the CRF for questions 3 to 6 and 8 to 11. In cases where more than one question was missing, a total score was not be imputed. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been present|Baseline (Week 0) and Week 12, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1223698|NCT00710684|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score at Week 24|RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1223712|NCT00710593|Secondary|Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-18 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
1223699|NCT00710684|Primary|Change From Baseline in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score at Week 24|The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or “box scores”, were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline(Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1223700|NCT00710684|Primary|Change From Baseline in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 24|ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the case report form (CRF) for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean is presented.|Baseline(Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1223701|NCT00710606|Secondary|Mean Endometrial Proliferation|The mean endometrial proliferation from week 1, week 2 and week3|Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||millimeters||Standard Deviation|Mean
1223702|NCT00710606|Secondary|Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up|Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter > 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).|continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||Participant w/follicular diameter >=13mm|||Number
1223703|NCT00710606|Primary|Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol|Serum concentrations were obtained from thirty-seven women completed follow-up.|Measurements at Week 3 and Week 6 continuous ring use|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||ng/L||95% Confidence Interval|Geometric Mean
1223704|NCT00710593|Secondary|Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).|Rate of AEs is the total number of AEs divided by the total number of participants. The rate is not a percentage bur rather it could be above 1 or less than 1. This outcome measure looked at number of AEs reported, by grade; number of AEs > Grade 3 identified; and number of AEs > Grade 3 evaluated within 24 or 48 hours.|Day 1 through Week 24||||AEs/Total Number of Participants|||Number
1223705|NCT00710593|Secondary|Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.|Visit compliance is the total number of days participants actually called the TRS or completed the VRC divided by the total number of days expected to call the TRS or complete the VRC, multiplied by 100%.|Day 1 through Week 24||||percentage of days||Standard Deviation|Mean
1223706|NCT00710593|Secondary|"Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the 12-item Knowledge About HPV and HPV Vaccine Measure)"|"To characterize young women's risk perceptions, sexual behaviors, and sexually transmitted infections (STI) diagnoses over the 48 weeks after initial vaccination, the relationship of baseline 12-item Knowledge About HPV and HPV Vaccine measure was used to evaluate the need for safer sexual behaviors."|Week 48|Total population analyzed was 99 participants. Percentage of participants reflects percentage of participants in both lower NSSB and higher NSSB.|||percentage of participants|||Number
1223707|NCT00710593|Secondary|Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination|"Participants’ perceptions for the need to practice safe sex following HPV vaccination was measured using a safer sexual behaviors subscale, which was comprised of the following five questions:~After getting vaccinated against HPV …~You feel that condom use during sex is less necessary.~You feel it is still just as important to have as few sexual partners as possible.~You feel that it is less important to talk to your sex partners about safe sex.~You think it is still just as important to use a condom every time you have sex.~You will be less worried about having unprotected sex. Those who were categorized in the “lower need for safer sexual behaviors (NSSB)” group had a summary score that was less than the median and those in the “higher NSSB” group had a summary score that was equal to or higher than the median."|Week 48||||percentage of participants|||Number
1223708|NCT00710593|Secondary|Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
1223709|NCT00710593|Secondary|Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
1223713|NCT00710593|Secondary|Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-16 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative for at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
1223714|NCT00710593|Secondary|Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-11 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
1223715|NCT00710593|Secondary|Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-6 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
1223716|NCT00710593|Primary|HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
1223717|NCT00710593|Primary|HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
1223718|NCT00710593|Primary|HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
1223719|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||mMU/mL||Standard Deviation|Geometric Mean
1223720|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||mMU/mL||Standard Deviation|Geometric Mean
1223721|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
1223722|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.|Week 48|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
1223723|NCT00710593|Secondary|Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine|When a subject had at least one adverse event or sign/symptom during the study after doses 1, 2 or 3, and the event was possibly, probably, or definitely related to vaccine, this subject was considered to have had a vaccine-associated adverse event, sign and/or symptom.|Entry, Week 8, and Week 24|Subjects who had at least one event that was possibly, probably, or definitely related to vaccine.|||participants|||Number
1223724|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18|Subjects who had a >= 24 mMU/mL were classified as responders; subjects who had a less than < 24 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
1223725|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16|Subjects who had a >= 20 mMU/mL were classified as responders; subjects who had a less than < 20 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
1223961|NCT00709098|Primary|Treatment-emergent Adverse Events|Number of adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population|||adverse events|||Number
1223726|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11|Subjects who had a >= 16 mMU/mL were classified as responders; subjects who had a less than < 16 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
1223727|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6|Subjects who had a greater than or equal to (>=) 20 Milli-Merck units (mMU)/milliliter (mL) response were classified as responders; subjects who had a less than (<) 20 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV Sero-Negative at baseline.|||participants|||Number
1223728|NCT00710593|Primary|HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)|The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at baseline (BL).|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
1223729|NCT00710554|Secondary|Incidence of Adverse Events as a Measure of Subject's Safety.|The number of subjects that reported an adverse event in this study is presented.|19 weeks|All subjects were included in this analysis.|||participants|||Number
1223730|NCT00710554|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks)|Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|Days 0-7 and Days 92-98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||number of tablets||Standard Deviation|Mean
1223731|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223732|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223733|NCT00710554|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223734|NCT00710554|Secondary|Subject Global Impression of Change|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||participants|||Number
1223735|NCT00710554|Secondary|Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)|Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable).|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223746|NCT00710424|Secondary|Subject Global Impression of Change at the End of Treatment|The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1223736|NCT00710554|Secondary|Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0–10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223737|NCT00710554|Secondary|Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223738|NCT00710554|Secondary|Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223739|NCT00710554|Primary|Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)|"The peripheral neuropathic pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|Day 7 to Day 98|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223740|NCT00710424|Primary|Number of Responders at the 30% Improvement Level at the End of Treatment|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period."|Day 0 - Day 98|All subjects who were randomised and received at least one actuation of study medication were included in the analysis. Subjects with no data during the primary period (i.e. unknown response) were included in the analysis, and were classed as non-responders.|||participants|||Number
1223741|NCT00710424|Secondary|Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment|Subjects rated their intoxication levels on a scale of 0-10, where 0 equals “no intoxication” and 10 equals “extreme intoxication”. A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223742|NCT00710424|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented.|Day 0 - Day 133|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1223743|NCT00710424|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End of Treatment|The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||Tablets||Standard Deviation|Mean
1223744|NCT00710424|Secondary|Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale|The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223745|NCT00710424|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment|The brief pain inventory (short form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The pain severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1224424|NCT00706823|Primary|Leak Pressure|After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.|duration of intubation||||cm of H2O||Standard Deviation|Mean
1223747|NCT00710424|Secondary|Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment|"The sleep quality Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your sleep quality in the last 24 hours where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment)."|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223748|NCT00710424|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period.|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223749|NCT00710424|Primary|The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis."|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1223750|NCT00710385|Secondary|"Drug Liking"|"Participant's subjective ratings of how much they Like the dose they just received on a scale of 0 -100."|Peak (highest) rating obtained following drug administration throughout the entire 3 hr session||||units on a scale||Standard Error|Mean
1223751|NCT00710385|Primary|Drug's Breakpoint|"Measure of a drug's reinforcing effects. The Breakpoint is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested"|Single measurement taken following each of the 7 IV experimental doses|Heroin users, not seeking treatment|||number of clicks on a mouse||Standard Deviation|Mean
1223752|NCT00710203|Other Pre-specified|Evidence of Texture Irregularities|The physician assessed evidence of texture irregularities.|6 to 12 weeks||||lesions|||Number
1223753|NCT00710203|Other Pre-specified|Evidence of Scar|The physician assessed evidence of scar.|6 to 12 weeks||||lesions|||Number
1223754|NCT00710203|Other Pre-specified|Evidence of Hyperpigmentation|The physician assessed evidence of hyperpigmentation.|6 to 12 weeks||||lesions|||Number
1223755|NCT00710203|Other Pre-specified|Evidence of Hypopigmentation|The physician assessed evidence of hypopigmentation.|6 to 12 weeks||||lesions|||Number
1223756|NCT00710203|Primary|Percent Clearance of All Lesions|The physician assessed percent clearance of all treated lesions and the control lesion.|6 to 12 weeks||||percentage of lesion clearance|Participants|Standard Deviation|Mean
1223757|NCT00710034|Secondary|Product Effect on Biomarkers of Exposure and Toxicity|Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).|Baseline and Week 4 post smoking substitution||||pmol//mg creatinine||Standard Deviation|Mean
1223758|NCT00710034|Secondary|Products Effect on Withdrawal Symptoms.|Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.|Week 1-12 post switching|Using assigned product only. The numbers of subjects that were only using the assigned product were 40 and 37 for nicotine gum and oral tobacco respectively at week 12. Analysis was conducted from weeks 1-12 post-switching.|||units on a scale||Standard Deviation|Mean
1223759|NCT00710034|Primary|Number of Products Used|Pieces of product per week at mid intervention|6 weeks post smoking substitution||||Pieces per week||Standard Deviation|Mean
1223760|NCT00710034|Primary|Number of Cigarettes Smoked|Cigarettes per day at mid intervention|6 weeks post cigarette substitution||||cigarettes per day||Standard Deviation|Mean
1223761|NCT00710034|Primary|Product Effect on Complete Substitution for Smoking|Number of subjects using only the assigned study product at week 6|6 week post smoking substitution||||participants|||Number
1223762|NCT00710021|Secondary|Percent of Participants With Adverse Events of Grade 3 or Above|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From start of study treatment through Week 12|Safety|||Percent of participants|||Number
1223763|NCT00710021|Secondary|Renal BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Renal-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223764|NCT00710021|Secondary|Ophthalmic BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Ophthalmic-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223765|NCT00710021|Secondary|Neuropsychiatric BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Neuropsychiatric-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223766|NCT00710021|Secondary|Musculoskeletal BILAG Status at Week 12|Outcome measure description: The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Musculoskeletal-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223767|NCT00710021|Secondary|Mucocutaneous BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Mucocutaneous-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223768|NCT00710021|Secondary|Hematological BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Hematological-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223769|NCT00710021|Secondary|Gastrointestinal BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Gastrointestinal-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223770|NCT00710021|Secondary|Constitutional BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Constitutional-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223771|NCT00710021|Secondary|Cardiorespiratory BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Cardiorespiratory-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1223772|NCT00710021|Secondary|Change in SELENA-SLEDAI Total Score From Baseline to Week 12|The modified Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. For this study, the SELENA-SLEDAI score was modified to include proteinuria defined by dipstick rather than 24 hour urine. Positive change in the SELENA-SLEDAI score indicate increased disease activity.|0, Week 12|Modified Intent-to-Treat with available data|||Change in Scores on a Scale||Standard Deviation|Mean
1223773|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 6|Modified Intent-to-Treat with available data|||Percent of participants|||Number
1249845|NCT00513526|Primary|Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine||All study visits|Intention to treat (i.e., received at least one dose of the vaccine)|||participants|||Number
1223774|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 12|Modified Intent-to-Treat with available data|||Percent of participants|||Number
1223775|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 6|Outcome measure description: C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
1223776|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 12|C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
1223777|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 6|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
1223778|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 12|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
1223779|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6|The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1223780|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12|The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1223781|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6|The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1223782|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12|The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1223783|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6|The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1223784|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12|The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. This gene encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1223785|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 6|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.|||Percent of participants|||Number
1223786|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 12|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.|||Percent of participants|||Number
1223787|NCT00710021|Secondary|Percent of Participants With an IFN Alpha Signature Response at Week 6|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.|||Percent of participants|||Number
1223788|NCT00710021|Primary|Percent of Participants With an IFN Alpha Signature Response at Week 12|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.|||Percent of participants|||Number
1223789|NCT00709956|Secondary|Borg Dyspnea Score|"The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labeled extremely severe, or the worst possible dyspnea imaginable. Reliability and validity have been reported in a general population and in patients with PAH as well as other respiratory conditions."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.|||scores on a scale||Standard Deviation|Mean
1223790|NCT00709956|Primary|6-minute-walk Distance (6MWD)|"The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk.~It was conducted by a trained member of the site staff who was listed on the site’s delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.|||meters||95% Confidence Interval|Least Squares Mean
1223791|NCT00709891|Secondary|Percentage of Participants With a Diagnosis of ≥ CIN3|A diagnosis of ≥ CIN3 (cervical intraepithelial neoplasia) included histology results of CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the study (up to 5 years, 1 month)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).|||Percentage of participants|||Number
1223792|NCT00709891|Primary|Percentage of Participants With a Diagnosis of ≥ CIN2|A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the Baseline period (up to 12 weeks)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).|||Percentage of participants|||Number
1223793|NCT00709878|Primary|Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.||6 months||||Total number of cases|||Number
1223794|NCT00709852|Secondary|Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers|From the quantitative signal intensity values assessed by the BR, the percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced was calculated.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of lesion enhancement||Standard Deviation|Mean
1223795|NCT00709852|Secondary|Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers|Two BRs independently provided the number of contrast-enhanced lesions for gadobutrol and gadoteridol. In cases of disagreement between the readers, an independent adjudicator provided the number of contrast-enhanced lesions. The adjudicator results were used in the analysis in the cases of disagreement between the original readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1223796|NCT00709852|Secondary|Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher|Percentage of participants for which blinded readers said image quality was higher|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223797|NCT00709852|Secondary|Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers|The BRs evaluated the relative image quality of the gadobutrol-enhanced T1w MR images and the gadoteridol-enhanced T1w MR images in a paired fashion on a 5-point scale where 1 = image on right was worse, 2 = image on right was slightly worse, 3 = both images were the same, 4 = image on right was slightly better, and 5 = image on right was better.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223798|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the combined unenhanced/gadobutrol-enhanced MR image sets and the combined unenhanced/gadoteridol MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223799|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadoteridol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223800|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadobutrol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223801|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223802|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223803|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223804|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223805|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223806|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223807|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223808|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223809|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223810|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223811|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223812|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223813|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1224425|NCT00706823|Secondary|Number of Participants With Oropharyngeal Discomfort|Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.|post operative, immediately and 24 hrs after intubation||||participants|||Number
1223814|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223815|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223816|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223817|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223818|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223819|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223820|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223821|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223839|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1223822|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223823|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223824|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223825|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223826|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223827|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223828|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223829|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223892|NCT00709592|Secondary|Donor Lymphocyte Infusion||2 year rate of DLI||||percentage of participants|||Number
1224955|NCT00703391|Primary|QTcF (QT Interval Corrected for Heart Rate by Fridericia’s Method)|QTcF interval greater than 450 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1223830|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223831|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the clinical investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1223832|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1223833|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1223834|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1223835|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1223836|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1223837|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223838|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223840|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223841|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223842|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223843|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1223844|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223845|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223846|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223847|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1223848|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223849|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223893|NCT00709592|Secondary|Relapse|Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans.|2 year relapse rate (%)||||Percent patients relapsing|||Number
1223850|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223851|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1223852|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1223853|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223854|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1223855|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223856|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223857|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223858|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223859|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223894|NCT00709592|Secondary|Event-free Survival||2 years||||percentage of participants|||Number
1223895|NCT00709592|Secondary|Treatment Related Mortality||Day 100||||percentage of patients|||Number
1223896|NCT00709592|Secondary|Survival||2-year survival rate (%)||||percentage of patient surviving|||Number
1223897|NCT00709592|Secondary|Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT.||Up to 52 weeks post transplant.||||Days||95% Confidence Interval|Median
1223860|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223861|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223862|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223863|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223864|NCT00709852|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1223865|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223866|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223867|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1223898|NCT00709592|Primary|The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine.|A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).|Up to 9 months following transplant||||participants|||Number
1223899|NCT00709319|Primary|Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months|Change in thickness is followup thickness minus baseline thickness.|Baseline to 6 months||||participants|||Number
1223868|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI, combined unenhanced and gadobutrol-enhanced MRI, and combined unenhanced and gadoteridol-enhanced MRI, excluding the sample participants (the first participant from each study site).|||scores on a scale||Standard Deviation|Mean
1223869|NCT00709826|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Randomization then every other cycle|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.16 between the proportions of patients who were progression free in AP/EG (0.35) and P/EG (0.19) after 9 months; an overall sample size of approximately 110 patients (73 in AP/EG and 37 in P/EG) was randomized in a 2:1 ratio.|||Months||95% Confidence Interval|Median
1223870|NCT00709826|Secondary|Overall Survival||Randomization then every other cycle||||Months||95% Confidence Interval|Median
1223871|NCT00709761|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner.|Start of treatment to disease progression or death (up to Week 131)|ITT Population|||weeks||95% Confidence Interval|Median
1223872|NCT00709761|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the start of treatment until the earliest date of disease progression or death due to breast cancer.|Start of treatment to disease progression or death (up to Week 131)|ITT Population|||weeks||95% Confidence Interval|Median
1223873|NCT00709761|Secondary|Time to Response (TTR)|TTR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first).|Start of treatment to first documented response (CR or PR) (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.|||weeks||95% Confidence Interval|Median
1223874|NCT00709761|Secondary|Duration of Response (DOR)|DOR was defined for the subset of participants who showed a confirmed CR or PR, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|First documented response (CR or PR) to disease progression or death (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.|||weeks||95% Confidence Interval|Median
1223875|NCT00709761|Secondary|Overall Survival (OS)|OS was defined as the time from the start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. OS could not be analyzed because only 13 participants had died as of data cut off, and data were not mature (greater than 75% of the participants were censored for the endpoint).|Start of treatment to death (up to Week 131)|ITT Population||||||
1223876|NCT00709761|Primary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR is defined as the disappearance of all lesions (target and/or non-target). PR is defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Start of treatment to disease progression or death or discontinuation from study or at least 28 days after last dose (up to Week 131)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||percentage of participants|||Number
1223877|NCT00709735|Secondary|Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score|IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 2 IES-R total score from the Day 8 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms.|Day 2 (Baseline ) and Day 8|All randomized participants who completed the study.|||score on a scale||Standard Deviation|Mean
1223878|NCT00709735|Primary|Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Traumatic Memory Recollection|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven imagery of traumatic combat events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant’s posterior probability of being classified as PTSD.|Day 8|All randomized participants who completed the study.|||percent probability||Standard Deviation|Mean
1223879|NCT00709722|Secondary|Treatment Days With Corticosteroids of <= 7.5 mg/Day|"Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day).~OCS dosage was maintained, decreased or increased according to the response to DSG.~The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle."|1st and 9th Cycle|ITT population|||Days||Full Range|Mean
1223880|NCT00709722|Secondary|SELENA-SLEDAI Score|The “Safety of Estrogen in Lupus Erythematosus National Assessment – systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity.|Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks|ITT population|||Score on a scale||Full Range|Mean
1223881|NCT00709722|Primary|Complete and Partial Response Rate|A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.|Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks|ITT population|||Percentage of participants|||Number
1223882|NCT00709696|Primary|Nicotine Withdrawal Scale|Scale is equal to days subject did not smoke Scale is 0-5 0 being no days 5 being did not quit at all|21 days|Treatment-seeking smokers|||units on a scale||Standard Deviation|Mean
1223883|NCT00709618|Secondary|Overall Survival|OS is defined as the time from the start of study treatment to the date of death. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Overall survival was not assessed because the study was terminated due to low screening and a low enrollment rate after 3 years. There were no-survival follow-up visits required.|From the start of study treatment to the date of death, assessed for up to 3 years|||||||
1223884|NCT00709618|Secondary|Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine|Qualitative and quantitative toxicities associated with the combination of lapatinib and vinorelbine during the study are those adverse events (AEs) that are judged to be related to the study treatment by the investigator. Those AEs occuring in more than 5 participants in the ITT Population are listed here.|From the start of study medication until disease progression, assessed every 4 weeks for up to 2 years|ITT Population|||participants|||Number
1223885|NCT00709618|Secondary|Time to Progression (TTP), as Assessed by the Investigator|TTP is defined as the time from the start of treatment until the earliest date of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to breast cancer, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).|||weeks||95% Confidence Interval|Median
1223886|NCT00709618|Secondary|Time to Response, as Assessed by the Investigator|Time to response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||weeks||95% Confidence Interval|Median
1223887|NCT00709618|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the first documented evidence of CR or PR until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to any cause, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||weeks||95% Confidence Interval|Median
1223888|NCT00709618|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the time from the start of treatment until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).|||weeks||95% Confidence Interval|Median
1223889|NCT00709618|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesions)/recurrence.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|Intent-to-Treat (ITT) Population: participants who received >=1 dose of investigational product. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||participants|||Number
1223890|NCT00709592|Secondary|Chronic Graft-Versus-Host Disease (GVHD)||2 year GVHD rate||||percentage of participants|||Number
1223891|NCT00709592|Secondary|Acute Graft-Versus-Host Disease (GVHD)||2 year rate (%)||||percentage of participant|||Number
1223903|NCT00709319|Primary|Visual Acuity|Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 6 months||||Units on a scale||Inter-Quartile Range|Median
1223904|NCT00709306|Primary|Sun Stage of Change at 12 Months|The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).|12 months||||Participants|||Count of Participants
1223905|NCT00709306|Primary|Sun Stage of Change at 3 Months|The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).|3 months||||Participants|||Count of Participants
1223906|NCT00709228|Primary|Number of HCV LVL G1 Participants Who Relapsed|Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.|Week 24 of follow-up|The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data.|||Participants|||Number
1223907|NCT00709124|Secondary|Subgroup Analysis|"For patients with >= 7 days of mechanical ventilation, we will compare the 2 groups for the following outcomes: Lower extremity muscle strength, mean change in whole body muscle strength score from baseline to ICU discharge, mean change in whole body muscle strength score from baseline to hospital discharge, and whole body muscle strength score at ICU discharge and at hospital discharge.~Each muscle group is assessed bilaterally (scale of 0 [no visible or noticeable contraction] to 5 [maximum strength]). There are three muscle groups assessed bilaterally for lower extremity (hip flexion, knee extension, and ankle dorsiflexion) (score range 0-30, higher score is better i.e. stronger); while for whole body strength assessment (score range 0-360, higher score is better), the following additional muscles are assessed: shoulder abduction, elbow flexion and wrist extension.~The scores are then summed for each patient at each time point."|ICU and hospital discharge and change over time|This was an a priori subgroup analyses of patients who had mechanical ventilation duration >=7 days. Not all participants could be evaluated at each time point (e.g. cognitive status) and this explains the different sample sizes for each outcome.|||muscle strength score (higher is better)||Standard Deviation|Mean
1223908|NCT00709124|Secondary|ICU Delirium|Proportion of ICU days the patient had delirium|During ICU stay - on days with study (NMES/Sham) session||||Mean % delirious days|Days of session|Standard Deviation|Mean
1223909|NCT00709124|Secondary|Mean Change in Subject’s Lower Extremity Muscle Strength Composite Score From Baseline|"The mean change of the sum of the lower limb strength scores between awakening and ICU discharge and between ICU discharge and hospital discharge.~Three lower limb muscle groups are assessed bilaterally (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength]). The scores are then summed for each patient at each time point (range 0 -30, higher score is better)."|At ICU and Hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Score||Standard Deviation|Mean
1223910|NCT00709124|Secondary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps)|Measured via manual muscle strength test using a composite Medical Research Council (MRC) score with each muscle group rated with score ranging from 0 (no visible or noticeable contraction of the muscle) to 5 (maximum strength). The sum of the scores for the lower limb muscle groups can range from 0 to 30 (higher score is better)|At hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Score||Standard Deviation|Mean
1223911|NCT00709124|Secondary|Hospital Discharge Destination (e.g., Home, Rehab Facility)|Discharge location after hospital stay.|Hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||Participants|||Count of Participants
1223912|NCT00709124|Secondary|Total Hospital Charges|The total dollar amount of charges from hospital stay|Hospital discharge||||US dollars||Standard Deviation|Mean
1223913|NCT00709124|Secondary|ICU and In-hospital Mortality|The number of patients who died in the ICU and those who died by hospital discharge.|ICU discharge and Hospital discharge||||Participants|||Count of Participants
1223914|NCT00709124|Secondary|ICU and Hospital Length of Stay|The number of days that the patient was in the ICU and hospital, respectively.|ICU and Hospital discharge||||days||Standard Deviation|Mean
1223915|NCT00709124|Secondary|Duration of Mechanical Ventilation|The number of days the patient was on mechanical ventilation.|Until hospital discharge||||days||Standard Deviation|Mean
1223916|NCT00709124|Secondary|Functional Status Measured Using Functional Status Score for the Intensive Care Unit|Evaluates a patient’s physical function in the ICU setting. Each task is scored, ranging from 0 (unable to perform) to 7 (complete independence).The total score ranges from 0-35, with higher scores indicating better physical functioning.|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||FSS-ICU Score||Standard Deviation|Mean
1223917|NCT00709124|Secondary|Respiratory Muscle Strength|Measured using maximal inspiratory pressure (MIP) measurements that is then compared to predicted values for each participant (i.e., % predicted)|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||% predicted||Standard Deviation|Mean
1223918|NCT00709124|Secondary|Hand Grip Strength|Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield % predicted)|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||% predicted||Standard Deviation|Mean
1223958|NCT00709098|Primary|Patients With Adverse Events Leading to Premature Discontinuation of Study Drug|Number of patients with adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.||||participants|||Number
1223919|NCT00709124|Secondary|Overall Body Strength|Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Composite Score||Standard Deviation|Mean
1223920|NCT00709124|Secondary|Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength|Strength (in pounds) - measured via handheld dynamometry of tibialis anterior, gastrocnemius, and quadriceps|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||pounds||Standard Deviation|Mean
1223921|NCT00709124|Primary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score|Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups|At hospital discharge||||units (range 0-30; higher is better)||Standard Deviation|Mean
1223922|NCT00709111|Secondary|Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall|Self-reported MVC adherence data were based on a four-day (8 expected doses) recall. Based on the wording of the Self Report case report form (CRF), participants reporting that they were currently taking MVC that then failed to complete the record of the number of missed doses were assumed to have no missed doses to report. Missing adherence assessments at a time point of interest were ignored and only those participants completing an adherence assessment at least one time point of interest were included.|At weeks 4, 12, and 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.|||doses missed||Full Range|Median
1223923|NCT00709111|Secondary|Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)|A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml.|At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36|As-treated: Participants who initiated treatment were included. Through week 24, follow-up while receiving MVC without change in background regimen were included. For week 36, only results obtained while receiving background regimen were included. One subject who had a large rise (blip) in viral load at week 24 was excluded.|||proportion of participants|||Number
1223924|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1223925|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||ng/ml||90% Confidence Interval|Median
1223926|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||pg/ml||90% Confidence Interval|Median
1223927|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mg/dl||90% Confidence Interval|Median
1223928|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1223929|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||ng/ml||90% Confidence Interval|Median
1223930|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||pg/ml||90% Confidence Interval|Median
1223931|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mg/dl||90% Confidence Interval|Median
1223932|NCT00709111|Secondary|Change in D-dimer|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1223959|NCT00709098|Primary|Adverse Events Leading to Premature Discontinuation of Study Drug|Number of adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.|Safety population|||adverse events|||Number
1223933|NCT00709111|Secondary|Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||ng/ml||90% Confidence Interval|Median
1223934|NCT00709111|Secondary|Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||pg/ml||90% Confidence Interval|Median
1223935|NCT00709111|Secondary|Change in High Sensitivity C-reactive Protein (Hs-CRP)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mg/dl||90% Confidence Interval|Median
1223936|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1223937|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1223938|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values). Soluble CD14 is a marker of gut microbial translocation.|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1223939|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
1223940|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
1223941|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
1223942|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
1223943|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
1223944|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
1223960|NCT00709098|Primary|Treatment-emergent Serious Adverse Events|Number of serious adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population|||serious adverse events|||Number
1223945|NCT00709111|Secondary|Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.|Events with date of onset or specimen date prior to first dose of MVC or after the last dose of MVC were excluded. Signs and symptoms with a date of onset the same as the first dose of MVC were excluded if confirmed by the site to be before the first dose. Lab abnormalities with the date of specimen the same as the date of the first dose of MVC were excluded on the assumption that the specimen was drawn before the first dose. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.|From baseline through week 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.|||participants|||Number
1223946|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 48 CD4 percentage (average of week 46 and week 48) minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4 percentage or a week 48 CD4 percentage obtained while receiving background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
1223947|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4 percentage obtained while receiving background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
1223948|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4 percentage (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.|||% of total lymphocytes/year||90% Confidence Interval|Mean
1223949|NCT00709111|Secondary|Within-subject CD4 Percentage Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.|||% of total lymphocytes/year||90% Confidence Interval|Mean
1223950|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as the week 24 CD4 percentage (average of the week 22 and week 24 values) minus the baseline CD4 percentage (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4 percentage or a week 24 CD4 percentage obtained while receiving MVC without change in background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
1223951|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 48 CD4+ T-cell count (average of week 46 and week 48) minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4+ T-cell count or a week 48 CD4+ T-cell count obtained while receiving background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
1223952|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 36 CD4+ T-cell count minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4+ T-cell count obtained while receiving background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
1223953|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4+ T-cell counts (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.|||cells/mm^3/year||90% Confidence Interval|Mean
1223954|NCT00709111|Secondary|Within-subject CD4+ T-cell Count Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.|||cells/mm^3/year||90% Confidence Interval|Mean
1223955|NCT00709111|Secondary|Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count|Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.|||proportion of participants||90% Confidence Interval|Number
1223956|NCT00709111|Primary|Change in CD4+ T-cell Count|Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
1223962|NCT00709059|Primary|Number of Study Participants Who Had a Virological Response (VR) at Week-72|"VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.~Participants who dropped out or were withdrawn from treatment were considered not to respond."|Treatment Week 72|Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72.|||Participants|||Number
1223963|NCT00708942|Secondary|Incidence of Patients With Adverse Events||3 months|All patients treated|||percentage of no of patients analyzed|||Number
1223964|NCT00708942|Secondary|Eradication of HPV|High risk HPV|6 months|Patients who were positive for high risk HPV at baseline|||percentage of no. of patients analyzed|||Number
1223965|NCT00708942|Primary|Complete Response Rate|"Based on histology, cytology and HPV status. Complete response is defined as normal pathology, normal cytology and negative HPV."|6 month|Per protocol population. Patients with major protocol violations excluded.|||percentage of no. of patients analyzed|||Number
1223966|NCT00708877|Primary|Transplant-related Mortality|Determined mortality-related transplant outcomes.|2 years|Entire cohort was used for analysis.|||participants|||Number
1223967|NCT00708851|Secondary|The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.|Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores were filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.|||participants|||Number
1223968|NCT00708851|Primary|The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.|Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores we filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.|||percent improvement from baseline||Full Range|Mean
1223969|NCT00708734|Primary|Gait and Balance Measures|Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.|5 months|The purpose of this pilot study was to evaluate the feasibilty of a structured, group exercise program in this population. Only 3 of 10 participants completed the study, due to high attrition, the project was considered unfeasible and data was not analysis.||||||
1223970|NCT00708721|Secondary|Number of Participants With Adverse Events|NCI CTCAE version 3.0 will be used to assess adverse events. The number of participants experiencing adverse events and the number of adverse events per patient will be documented through the course of study.|To 30 days after end of treatment or until full resolution.|All participants experienced at least 1 adverse event (100% of the patient population; 11/11 participants)|||participants experiencing adverse events|||Number
1223971|NCT00708721|Secondary|The Effect of Low Dose Daily Oral Clofarabine on miRNA and mRNA Expression Patterns in Patients With MDS|Assessment of potential change in miRNA and mRNA genetic expression patterns in patients following administration of low dose daily clofarabine.|through end of treatment|Data were not collected and the outcome measure was not analyzed||||||
1223972|NCT00708721|Secondary|The Effect of Low Dose Daily Oral Clofarabine on Global Methylation in Patients With MDS.|Potential genomic changes following low dose daily oral clofarabine administration will be assessed.|through end of treatment|Data were not collected and the outcome measure was not analyzed||||||
1223973|NCT00708721|Secondary|Response of MDS Patients Treated With Low Dose Daily Oral Clofarabine.|Stable disease is defined as failure to achieve at least PR, but no evidence of progression for > 8 weeks.|approximately 4 years|Of 11 patients, 9 were evaluable for response. Two patients had stable disease responses.|||Participants|||Count of Participants
1223974|NCT00708721|Secondary|Time to Progression to Acute Myeloid Leukemia (AML)|Longest documented duration of time until progression to AML.|approximately 4 years|Cycles are 28 days long. Analysis assessed the longest number of cycles completed on study until progression to AML.|||cycles|||Number
1223975|NCT00708721|Primary|The Overall Response Rate in Response to Low Dose Daily Oral Clofarabine in Patients With High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (Dysplastic Type).|Response rate was measured as complete, partial and hematologic improvement by modified IWG criteria. For complete remission the following must be present for four weeks in a bone marrow aspirate and biopsy: <5% myeloblasts, normal maturation of all cell lines, persisted dysplasia. Peripheral blood counts need to be hemoglobin >11 g/dL, neutrophils >1000/mm3, platelets>100000/mm3, blasts 0%. Partial remission requires all criteria for complete remission except blasts decreased by >50% over pretreatment. Stable disease is defined as failure to achieve at least partial remission, but no evidence of progression for > 8 weeks. Failure is defined as death during tre3atment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment.|4 weeks|Two patients were not eligible for analysis.|||participants who experienced a response|||Number
1223976|NCT00708721|Primary|Number of Participants Who Experienced a Dose-Limiting Toxicity|Dose-limiting toxicity was defined as any nonhematologic toxicity grade 3 or greater except for alopecia or nausea (which may be of grade 4 severity), or any grade 4 hematologic toxicity lasting more than 28 days after the last day of therapy.|28 days after the first admistration of oral clofarabine|9 out of 11 participants were evaluable for this outcome.|||participants who experienced a DLT|||Number
1224084|NCT00708435|Secondary|Transfusion of Red Blood Cells|Red blood cells were packed red blood cells (PRBCs).|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||Units of PRBCs||Standard Deviation|Mean
1223977|NCT00708708|Secondary|Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs.|Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24)|Safety analysis set included all participants with available post-baseline safety data.|||participants|||Number
1223978|NCT00708708|Secondary|Criteria for Treatment Resumption|Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
1223979|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Recommendation of Therapy|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, “Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?” Participants responded as yes or no to the question. Results are reported for participant’s likeliness to recommend therapy.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points. Results are not reported for before Cycle 4, 5, 6, and after Cycle 5 as no participant was evaluable at these time points.|||participants|||Number
1223980|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Preference to Continuous Therapy|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, “If possible, would you prefer a continuous therapy without drug-free interval?” Participants responded as yes or no to the question. Results are reported for participant’s preference towards continuous therapy.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
1223981|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Comfort in Everyday Life|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “A drug-free interval means more comfort in my everyday life.” Results are reported for participant’s perception of comfort of life during the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223982|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reminder of Disease|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “During drug-free interval I will not be reminded permanently of my disease.” Results are reported for participant’s perception of reminder of disease during the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223983|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “A drug-free interval reduces the risk for adverse drug reactions.” Results are reported for participant’s perception of risk of adverse drug reactions.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223991|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Length of Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “How long do you expect the drug-free interval to last for?” After the drug-free interval participants were asked, “How long did the drug-free interval last?” Results are reported for participant’s perception of the length of drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||months||Standard Deviation|Mean
1223984|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How much were you satisfied with the condition of your skin during the first half of the drug-free interval?” and “How much were you satisfied with the condition of your skin during the second half of the drug-free interval?” Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant’s satisfaction with their skin condition during the first half and second half of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223985|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Disease Activity|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How would you assess the activity of your disease during the first half of the drug-free interval?” and “How would you assess the activity of your disease during the second half of the drug-free interval?” Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant’s perception of disease activity during the first half and second half of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223986|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?” After the drug-free interval participants were asked, “To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?” Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant’s perception of effective therapy after drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223987|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Relapse of Symptoms|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “How much are you concerned about a relapse of symptoms?” After the drug-free interval participants were asked, “Were you concerned about a relapse of symptoms during the drug-free interval?” Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant’s perception of relapse of symptoms.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223988|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Duration|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How would you assess the length of the current drug-free interval?” Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant’s perception of the duration of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223989|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “Do you basically like the idea of a drug-free interval?” After the drug-free interval participants were asked, “How did you like the current drug-free interval?” Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant’s liking of the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1223990|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reason for Returning to Practice|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “Why did you return to the practice today?” Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
1224956|NCT00703391|Primary|Leucocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||10**9/L||Standard Deviation|Mean
1223992|NCT00708708|Secondary|Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)|"Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here n’=number of participants evaluable at the specified time points for the given cycles.|||units on a scale||Standard Deviation|Mean
1223993|NCT00708708|Secondary|Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score|"Effect of drug free interval on DLQI was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst)."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ’n’=number of participants evaluable at the specified time points for the given cycles.|||units on a scale||Standard Deviation|Mean
1223994|NCT00708708|Secondary|Effect of Drug-Free Interval on Patient’s Global Assessment of Disease Activity (PatGA)|"Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1223995|NCT00708708|Secondary|Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications|Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Prior to study, Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.|||Euros||Standard Deviation|Mean
1223996|NCT00708708|Secondary|Average Cost of Treatment by Disease Severity|Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for the given disease severities.|||Euros||Standard Deviation|Mean
1223997|NCT00708708|Secondary|Annual Costs for Treatment With Etanercept|Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.|||Euros||Standard Deviation|Mean
1223998|NCT00708708|Secondary|Number of Participants With at Least 1 Concomitant Medication|Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported.|Cycle 1 Week 0 up to Cycle 6 Week 24|Safety analysis set included all participants with available post-baseline safety data.|||participants|||Number
1223999|NCT00708708|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1224000|NCT00708708|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1224001|NCT00708708|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1224002|NCT00708708|Secondary|Patient’s Global Assessment of Disease Activity (PatGA)|Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set included all participants >=18 years of age, confirmed diagnosis of plaque psoriasis, had not received treatment with etanercept previously and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1224003|NCT00708708|Secondary|Percentage of Time on Treatment Over Entire Period|Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1).|Cycle 1 up to Cycle 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of entire treatment period||Standard Deviation|Mean
1224004|NCT00708708|Secondary|Percentage of Time on Treatment in First Year|Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1.|Year 1|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of first year||Standard Deviation|Mean
1224005|NCT00708708|Secondary|Cumulative Dose of Etanercept Per Year|Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n' = participants evaluable at the specified time points for this outcome measure.|||mg||Standard Deviation|Mean
1224006|NCT00708708|Secondary|Number of Injections Per Year|Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable at the specified time points for this outcome measure.|||injections||Standard Deviation|Mean
1224007|NCT00708708|Secondary|Patient Global Assessment of Efficacy|Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.|||participants|||Number
1224008|NCT00708708|Secondary|Physician Global Assessment of Efficacy|Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.|||participants|||Number
1224009|NCT00708708|Secondary|Static Physician Global Assessment (sPGA) of Disease Activity|Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1224080|NCT00708461|Primary|Change in Body Mass Index (BMI)|Assessed in kilograms per meter squared.|Baseline to 24 months|Participants with complete data at baseline and two years, and those who were not pregnant at either time, were retained for analysis.|||kilograms per meter squared||Standard Error|Least Squares Mean
1224957|NCT00703391|Primary|Reticulocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||relative particle count (%)||Standard Deviation|Mean
1224010|NCT00708708|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points for each arm, respectively.|||percentage of BSA||Standard Deviation|Mean
1224011|NCT00708708|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1224012|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 6|Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 5 Week 24 up to Cycle 6 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1224013|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 5|Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 4 Week 24 up to Cycle 5 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1224014|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 4|Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 3 Week 24 up to Cycle 4 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1224015|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 3|Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 2 Week 24 up to Cycle 3 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post-baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1224016|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 2|Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 1 Week 24 up to Cycle 2 Week 0|Efficacy analysis set: all participants greater than or equal to (>=) 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1224017|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
1224118|NCT00708214|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria.|Baseline till progression, death or data cut-off (04 Jan 2010)|TS|||days||95% Confidence Interval|Median
1224018|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of Infant Series (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
1224019|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
1224020|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
1224021|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
1224022|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
1224023|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
1224024|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
1224025|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.|Toddler Dose (12 months of age)|Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose.|||mcg/mL||95% Confidence Interval|Geometric Mean
1224026|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 3 of infant series (6 months of age)|Evaluable 3-Dose Infant Immunogenicity population|||mcg/mL||95% Confidence Interval|Geometric Mean
1224027|NCT00708682|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 2 of infant series (4 months of age)|Evaluable 2-Dose Infant Immunogenicity population|||mcg/mL||95% Confidence Interval|Geometric Mean
1224083|NCT00708435|Secondary|Use of Other Blood Products and Hemostatic Agents|Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs.|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||Units of blood products||Standard Deviation|Mean
1224028|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1224029|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after dose 2 of the infant series (5 months of age)|Evaluable 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1224030|NCT00708682|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1224031|NCT00708643|Secondary|Corneal Staining|A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.||||units on a scale||Standard Error|Least Squares Mean
1224032|NCT00708643|Secondary|Tarsal Hyperemia|Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1224033|NCT00708643|Secondary|Tarsal Roughness|Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1224034|NCT00708643|Primary|Upper Lid Margin Staining|Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.|||units on a scale.||Standard Error|Least Squares Mean
1224035|NCT00708643|Primary|Lens Comfort|"Rating of lens comfort by rating agreement to the following statement:~The lenses I am wearing are comfortable.~Rating using the following scale:~1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames."|At 3,7,10,13,17,21,24, and 27 days|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1224036|NCT00708643|Primary|Limbal Hyperemia|Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1224037|NCT00708552|Secondary|Exposure Estimates for Donepezil Average Concentration at Steady State (Cavgss)|Blood sample for pharmacokinetic analysis, were obtained within 24 hours of last dose. A total of five pharmacokinetic samples per participants were taken at Weeks 4, 8,12,18 and Week 24. The Donepezil exposures at steady state Cavgss for each participant were estimated via nonlinear mixed effect analysis. Data has been presented in a consolidated format for SB-742457 exposures at steady state Cavgss.|Weeks 4, 8,12,18 and Week 24|Pharmacokinetic concentration population. Only those participants with data available at the time of analysis were included.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1224038|NCT00708552|Secondary|Exposure Estimates for SB-742457 Minimum Concentration at Steady State (Cmin-ss)|Blood sample for pharmacokinetic analysis, were obtained within 24 hours of last dose. A total of five pharmacokinetic samples per participants were taken at Weeks 4, 8,12,18 and Week 24. The SB-742457 exposures at steady state Cmin-ss for each participant were estimated via nonlinear mixed effect analysis. Data has been presented in a consolidated format for SB-742457 exposures at steady state Cmin-ss.|One sample at Day 28±5, 56±5, 84±5, 126±5 and 168±5 post 24 hours of last dose|Pharmacokinetic concentration population. Only those participants with data available at the time of analysis were included.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1224039|NCT00708552|Secondary|Exposure Estimates for SB-742457 Area Under Curve Over the Dosing Interval at Steady State (AUCτss)|A total of five pharmacokinetic samples per participant were collected for the purpose of assessing plasma concentrations of SB-742457 and donepezil. At each visit (Day 28±5, 56±5, 84±5, 126±5 and 168±5) one sample was collected post 24 hours of last dose.|One sample at Day 28±5, 56±5, 84±5, 126±5 and 168±5 post 24 hours of last dose|Pharmacokinetic concentration population comprised of all participants for whom a pharmacokinetic sample was obtained and analyzed. Only those participants with data available at the time of analysis were included.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1224040|NCT00708552|Secondary|Number of Participants With Electrocardiogram (ECG) Findings as Assessed by Investigator and Central Cardiologist|The clinical interpretation of the ECG by the investigator was recorded as Normal, Abnormal but not clinically significant (ANCS) and Abnormal clinically significant (ACS). ECG interpretation by the central cardiologist included the most extreme result of the available ECGs where the central cardiologist’s interpretation of the ECG was recorded as Normal, Unable to Evaluate and Abnormal. Data has been presented for number of participants with most severe on-treatment abnormal ECG findings.|Upto Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1224041|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Red Blood Cell Count at Week 24|Hematology parameter included red blood cell count. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||trillion cells per liter||Standard Deviation|Mean
1224042|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Mean Corpuscle Volume and Mean Platelet Volume at Week 24|Hematology parameter included mean corpuscle volume and mean platelet volume. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||femtoliters||Standard Deviation|Mean
1224043|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin at Week 24|Hematology parameter included mean corpuscle hemoglobin. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||picograms||Standard Deviation|Mean
1224044|NCT00708552|Secondary|Change From Baseline in Hematology Parameters Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Week 24|Hematology parameter included hemoglobin and mean corpuscle hemoglobin concentration. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
1224045|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Hematocrit|Hematology parameter included hematocrit. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Ratio||Standard Deviation|Mean
1224046|NCT00708552|Secondary|Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, White Blood Cell Count at Week 24|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils, white blood cell count. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||giga cells per liter||Standard Deviation|Mean
1224047|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Creatinine, Direct Bilirubin and Total Bilirubin at Week 24|Clinical chemistry parameters included creatinine, direct bilirubin and total bilirubin. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||umol/L||Standard Deviation|Mean
1224048|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Calcium, CO2 Content/Bicarbonate, Chloride, Glucose, HDL Cholesterol, LDL Cholesterol, Magnesium, Phosphorus, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen at Week 24|Clinical chemistry parameters included calcium, CO2 content/bicarbonate, chloride, glucose, HDL cholesterol, LDL cholesterol, magnesium, phosphorus, potassium, sodium, triglycerides, urea/blood urea nitrogen. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
1224049|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameter Blood Urea Nitrogen /Creatinine Ratio at Week 24|Clinical chemistry parameter included blood urea nitrogen /creatinine ratio. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Ratio||Standard Deviation|Mean
1224050|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein at Week 24|Clinical chemistry parameters included albumin and total protein. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||grams per liter||Standard Deviation|Mean
1224051|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Week 24|Clinical chemistry parameters included alanine amino transferase, alkaline phosphatase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time point were analyzed.|||IU/L||Standard Deviation|Mean
1224958|NCT00703391|Primary|Haemoglobin (Hb)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||g/L||Standard Deviation|Mean
1224052|NCT00708552|Secondary|Number of Participants With Chemistry Data of PCC ATOT|Clinical chemistry parameters included alanine amino transferase international units per liter (IU/L) RR [0-48], alkaline phosphatase IU/L (20-125), aspartate amino transferase international units per liter (0-55), blood urea nitrogen/creatinine ratio (24-101), calcium millimoles per liter (mmol/L) [2.12-2.56], carbon dioxide content/bicarbonate mmol/L (20-32), cholesterol mmol/L (0.00-5.15), creatine kinase IU/L (males 0-235 and females 0-190), creatinine micromoles per liter (umol/L) [44-124], direct bilirubin umol/L (0-6), gamma glutamyl transferase IU/L (males 0-65 and females 0-45), glucose mmol/L (3.9-6.9), low density lipoprotein cholesterol mmol/L (0.00-3.35), lactate dehydrogenase IU/L (0-270), potassium mmol/L (3.5-5.3), sodium mmol/L (135-146), total bilirubin umol/L (0-22), triglycerides mmol/L (0.00-2.24), urea/blood urea nitrogen mmol/L (2.5-10.5). Data has been presented in a consolidated format for clinical chemistry parameters high and low from the RR of PCC ATOT.|Upto Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1224053|NCT00708552|Secondary|Number of Participants With Hematology Data of PCC ATOT|Hematology parameters included hematocrit ratio (reference range males 0.410-0.500, females 0.350-0.460 [18-64 years] and males 0.360-0.490, females 0.330-0.460 [65+ years]), hemoglobin grams per liter (13.8-17.2), lymphocytes giga per liter (0.85-4.10), monocytes giga per liter (0.20-1.10), platelet count giga per liter (130-400), segmented neutrophils giga per liter (1.80-8.00), total neutrophils (1.80-8.00). Data has been presented in a consolidated format for hematology parameters high and low from the reference range of PCC ATOT.|Upto Week 24|Safety population. Only those participants available at the specified time point were analyzed.|||Participants|||Number
1224054|NCT00708552|Secondary|Number of Participants With Vital Signs Data of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT)|Vital sign measurements included systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Heart Rate (HR), Body weight (BW). SBP and DBP and HR were measured once after the participant sat quietly for at least 5 minutes and in addition, upon standing to assess participants for postural hypotension. DBP was measured at the disappearance of Korotkoff sounds (Phase V). The plethysmographic method (preferably with a column sphygmomanometer where available) was used to measure blood pressure throughout the study. Body weight was measured, without shoes and wearing light clothing. The PCC range were as follows: SBP (Reference Range [RR] <90-140> Increase from Baseline [IFB]>=40 and decrease from baseline [DFB] >=30), DBP (RR < 50-90> IFB>=30 and DFB >=20), HR (RR <50-100> IFB >=30 and DFB >=30, BW (IFB >= 7% and DFB >=7%).|Upto Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Number
1224055|NCT00708552|Secondary|Number of Participants With Any Adverse Event (Serious and Non-serious) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Number of participants with any adverse event (serious and non-serious) and SAEs were reported.|Upto Week 24|Safety population.|||Participants|||Number
1224056|NCT00708552|Secondary|Change From Baseline in ADCS-ADL-Basic Score; ADCS-ADL: Instrumental Score and ADCS-ADL: Total Independence Score at Weeks 12 and 24|Basic score was calculated as the sum of questions 1-6b and ranges from 0-22 (activities included are: eating, walking, using the toilet, bathing, grooming and dressing) and Instrumental score, sum of questions 7-23, ranges from 0-56 (activities included are: using the telephone, watching television, conversations, clearing dishes, personal belongings, making drinks, making snacks, taking rubbish out, getting out and about, shopping, keeping appointments, being left alone, current events, reading, writing, pastimes/hobbies, household chores). Total independence score is calculated by re-scoring the individual questions for each activity. The total independence score therefore ranges between 0 to 23, where 23 indicates that a participant is independent (based on these 23 ADL). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 12 and 24.|Baseline (Week 0) and Weeks 12 and 24|ITT population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224057|NCT00708552|Secondary|Change From Baseline in MMSE Total Score at Week 24|The MMSE is used to test for cognitive dysfunction. The scale is completed by a trained and experienced neurologist/psychiatrist/neuropsychologist based on the performance of the participants, and takes approximately 5 to 10 minutes to administer. It consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing, drawing across 5 sections (orientation, registration, attention-calculation, recall, and language). Scoring was done by circling 0 if the response was incorrect, or 1 if the response was correct. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better cognitive function. The total MMSE score was a sum of all item scores. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224081|NCT00708435|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. Treatment-related AEs were defined as events whose relationship to study treatment was definitely related, probably related, or possibly related in the opinion of the investigator. AEs with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent SAEs. Deaths reported up to and including Day 45; one additional Beriplex death occurred after Day 45.|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.|The ITT-S population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.|||participants|||Number
1224058|NCT00708552|Secondary|Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) Total Score at Week 24|The CSDD is used to assess signs and symptoms of major depression in demented participants. The CSDD scale contains 19 items on mood-related signs of depression, behavioral disturbance, physical signs of depression, cyclic functions and ideational disturbances, where each item is rated for severity on a scale of 0-2 (0=absent, 1=mild/intermittent, 2=severe). Scores above 10 (probable major depression),scores above 18 (definite major depression), scores below 6 (absence of significant depressive symptoms). The total score was calculated as a weighted average of the scores provided for the remaining 18 questions as follows: Imputed Total= Observed Total Score x 1+ Maximum Score of the missing value/ Sum of the Maximum Score of the non -missing values) and ranges from 0-38. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224059|NCT00708552|Secondary|Change From Baseline in Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Total Score at Weeks 12 and 24|The ADCS-ADL measures functional impairment in terms of activities of daily living. The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions (i.e. those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, making judgments and decisions) about the participant. The questions range from basic to instrumental activities of daily living and take approximately 20 minutes to complete. The Total score ranges from 0-78 and a higher score signifies greater functional ability and lower scores indicating greater impairment. The total score is the sum of all items and sub-questions. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 12 and 24.|Baseline (Week 0) and Weeks 12 and 24|ITT population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224060|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 10-20.|Week 12|Intent-to-Treat (Baseline MMSE 10-20). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224061|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 16-26.|Week 12|Intent-to-Treat (Baseline MMSE 16-26). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224062|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 12|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 10-20. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|Intent-to-Treat (Baseline MMSE 10-20). Only those participants available at the specified time-points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224063|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 12|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for Participants with Baseline MMSE score 16-26. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|Intent-to-Treat (Baseline MMSE 16-26). Only those participants available at the specified time-points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224426|NCT00706823|Secondary|Level of Difficulty for Intubation|Ease of SGA insertion and intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = very easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = very difficult).|duration of intubation||||participants|||Number
1224064|NCT00708552|Secondary|Change From Baseline in RBANS Total Score at Week 12|RBANS is an individually administered neurocognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). The scale is completed by a trained and experienced neurologist, psychiatrist or neuropsychologist, or another trained and experienced person. It is preferred that this individual is the same person who administers the ADAS-Cog, but he/she must be a separate individual from the person who completes the CIBIC+. The scale is based on the performance of the participant and takes approximately 25-30 minutes to administer. Raw total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where low score= (greater impairment) and high score=(better cognitive function). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224065|NCT00708552|Secondary|CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse).|Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224066|NCT00708552|Secondary|Change From Baseline in ADAS-Cog Total Score at Week 12|ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a five point scale. The ADAS-Cog total score is the sum of the calculated scores for Questions 1 (Word recall task), 2 (Naming objects and fingers), and 7 (Word recognition task) and the scores recorded on the CRF for Questions 3 to 6 (Commands, Constructional praxis, Ideational praxis, Orientation) and 8 to 11 (Remembering test instructions, Spoken language ability, Word finding difficulty in spontaneous speech, Comprehension). The total score ranges from 0-70 with higher scores indicating greater dysfunction while lower indicates better cognitive function. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224067|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the CIBIC+ Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Higher scores indicate worst outcome. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with baseline MMSE 10-20. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 10-20). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224068|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the CIBIC+ Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 16-26. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 16-26). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224069|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline [MMSE Scores 10-20) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 24|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 10-20. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 10-20) which comprised of participants who had a baseline MMSE score of 16-26. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224082|NCT00708435|Secondary|45-Day All-cause Mortality||Until Day 45|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||participants|||Number
1224119|NCT00708214|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|First occurence or OR till progression or death|TS. Median duration of RECIST tumour response was not calculable as there was no OR observed.|||days||95% Confidence Interval|Median
1224070|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline Mini Mental State Examination [MMSE] Scores 16-26) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 24|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 16-26. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 16-26) which comprised of participants who had a baseline MMSE score of 16-26. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224071|NCT00708552|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score at Week 24|RBANS is an individually administered neurocognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). The scale is completed by a trained and experienced neurologist, psychiatrist or neuropsychologist, or another trained and experienced person. It is preferred that this individual is the same person who administers the ADAS-Cog, but he/she must be a separate individual from the person who completes the CIBIC+. The scale is based on the performance of the participant and takes approximately 25-30 minutes to administer. Raw total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where low score= (greater impairment) and high score=(better cognitive function). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224072|NCT00708552|Primary|Clinician’s Interview-Based Impression of Change – Plus (CIBIC+) Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse).|Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224073|NCT00708552|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 24|ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a five point scale. The ADAS-Cog total score is the sum of the calculated scores for Questions 1 (Word recall task), 2 (Naming objects and fingers), and 7 (Word recognition task) and the scores recorded on the CRF for Questions 3 to 6 (Commands, Constructional praxis, Ideational praxis, Orientation) and 8 to 11 (Remembering test instructions, Spoken language ability, Word finding difficulty in spontaneous speech, Comprehension). The total score ranges from 0-70 with higher scores indicating greater dysfunction while lower indicates better cognitive function. Baseline was defined as the value at Week 0. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1224074|NCT00708526|Secondary|Return of Cognitive Function|average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth|up to 30 minutes|number of participants determined by protocol|||minutes||Standard Deviation|Mean
1224075|NCT00708526|Primary|Recovery From Anesthesia|average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).|up to 2 hours||||minutes||Standard Deviation|Mean
1224076|NCT00708500|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.||At Follow-up Week 12 and at 72 weeks after randomization|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||participants|||Number
1224077|NCT00708500|Secondary|Number of Participants With Early Virologic Response.|Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response.|At Week 2, 4, 8, or 12|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||participants|||Number
1224078|NCT00708500|Secondary|Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.|"SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment.~This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009."|At Follow-up Week 24|mITT = all randomized subjects who received at least one dose of boceprevir (experimental arms) or boceprevir placebo (control arm).|||Percentage of Participants|||Number
1224079|NCT00708500|Primary|Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.|SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.|At Follow-up Week 24|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||Percentage of Participants|||Number
1224085|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After Randomization|The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
1224086|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
1224087|NCT00708435|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From preinfusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of normal||Standard Deviation|Mean
1224088|NCT00708435|Secondary|Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex|The incremental IVR [(IU/dL)/(IU/kg)] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = [maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)]/{[exact dose of component in drug administered (IU)]/[body weight (kg)]}.|Before infusion and up to 3 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||(IU/dL)/(IU/kg body weight)||Standard Deviation|Mean
1224089|NCT00708435|Secondary|Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding|Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where ‘effective’ was a hemostatic efficacy rating of “excellent” or “good,” and ‘non-effective’ was a hemostatic efficacy rating of “poor/none”.|At 3 and 6 hours after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
1224090|NCT00708435|Primary|Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)|A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after end of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
1224091|NCT00708435|Primary|Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed|Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where ‘effective’ was a hemostatic efficacy rating of “excellent” or “good,” and ‘non-effective’ was a hemostatic efficacy rating of “poor/none”.|At 1 and 4 hours after the end of infusion|The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
1224092|NCT00708422|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.|||Units on a scale||Standard Deviation|Mean
1224093|NCT00708422|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.|||seconds||Standard Deviation|Mean
1224748|NCT00705367|Primary|Short-term Period: Mean Respirations Rate|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||Respirations per minute||Standard Deviation|Mean
1224094|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 4 hours post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1224095|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 2 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1224096|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 1 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1224097|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 30 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1224098|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 15 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1224099|NCT00708305|Secondary|Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||ln(μg*F*minutes/cm^2)||Standard Error|Log Mean
1224100|NCT00708305|Primary|Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||ln(μg*F*minutes/cm^2)||Standard Error|Least Squares Mean
1224101|NCT00708227|Secondary|Bronchodilator Response Following Methacholine Challenge at Visit 4|The area under the curve (AUC) bronchodilator response after Visit 4 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had discontinued Advair for 36 hours.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Advair for 2 weeks at Visit 3.|||Liters*min||Standard Deviation|Mean
1224120|NCT00708214|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|Baseline till progression|TS. Median time to RECIST tumour response was not calculable as there was no OR observed.|||days||95% Confidence Interval|Median
1224121|NCT00708214|Secondary|Number of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|16 weeks and 24 weeks|TS|||Participants|||Number
1224122|NCT00708214|Secondary|Number of Participants With Confirmed Objective Response (OR)|OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status.|Baseline till progression|TS|||Participants|||Number
1224102|NCT00708227|Secondary|Bronchodilator Response Following Methacholine Challenge at Visit 3|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Advair for 2 weeks at Visit 3.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Advair for 2 weeks at Visit 3.|||Liters*min||Standard Deviation|Mean
1224103|NCT00708227|Secondary|Bronchodilator Response to Methacholine (PC20) After Visit 2|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Flovent for 2 weeks at Visit 2.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.|All participants who had received Flovent for 2 weeks at Visit 2.|||Liters*min||Standard Deviation|Mean
1224104|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 4|Visit 4 log10 PC20 to Methacholine after stopping Advair|36 hours after the last dose of Advair|All participants who had a methacholine challenge at Visit 4. All participants had discontinued Advair for 36 hours.|||log10 mg/mL||Standard Deviation|Mean
1224105|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 3|Visit 3 Log10 PC20 after receiving 2 weeks of Advair|Visit 3:12 hours after the last dose of Advair|All participants who had a methacholine challenge at Visit 3. All participants had received Advair for 2 weeks.|||log10 mg/mL||Standard Deviation|Mean
1224106|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 2|Visit 2 log10 PC20 after receiving 2 weeks of Flovent|Visit 2:12 hours after last dose of Flovent|All participants who had a methacholine challenge at Visit 2. All participants had received Flovent for 2 weeks.|||log10 mg/mL||Standard Deviation|Mean
1224107|NCT00708214|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1|baseline till end of treatment||||participants|||Number
1224108|NCT00708214|Secondary|Change From Baseline in Ca15.3|Change from baseline in Ca15.3 tumor marker levels|baseline and day 29|Analysis of all treatment arms combined for tumor marker analysis.|||percentage of baseline level||Full Range|Median
1224109|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||hours||Full Range|Median
1224110|NCT00708214|Secondary|Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1224111|NCT00708214|Secondary|Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1224112|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||hours||Full Range|Median
1224113|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85)|Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85.|Day 85|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1224114|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1224115|NCT00708214|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1224116|NCT00708214|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1224117|NCT00708214|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death.|Baseline till progression, death or data cut-off|TS. Estimation of median time to death was not feasible, due to the small number of patients who died during the trial.|||days||95% Confidence Interval|Median
1224123|NCT00708214|Primary|Percentage of Progression Free Participants After 16 Weeks of Treatment|Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.|16 weeks|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
1224124|NCT00708201|Secondary|Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events|CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.|Baseline to 30 days post discharge|All participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1224125|NCT00708201|Secondary|Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points|DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.|||percentage of participants|||Number
1224126|NCT00708201|Secondary|Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points|Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.|||percentage of participants|||Number
1224127|NCT00708201|Secondary|Percentage of Participants With Postoperative Morbidity (POM)|POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.|During hospitalization or within 7 days after discharge|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable POM data.|||percentage of participants|||Number
1224128|NCT00708201|Secondary|Percentage of Participants Considered Postoperative LOS Responders|A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.|Day of surgery (Day 0) up to 7 days after surgery|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.|||percentage of participants|||Number
1224129|NCT00708201|Secondary|Postoperative Length of Stay (LOS)|The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).|Day of surgery (Day 0) to the day of hospital DOW|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.|||Days||Standard Deviation|Mean
1224130|NCT00708201|Secondary|Mean Time to Discharge Order Written (DOW) Using KM Estimates|"The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to DOW data. 36 participants in the Placebo group and 15 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
1224131|NCT00708201|Secondary|Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model|"The endpoint of “time to ready for discharge” was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable ready to discharge data. 21 participants in the Placebo group and 12 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
1224148|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1224149|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1224132|NCT00708201|Primary|Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model|"Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement [BM]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|From day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data. 39 participants in the Placebo group and 17 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
1224133|NCT00708175|Other Pre-specified|Number of Participants With Fracture|Number of participants with confirmed (through an adjudication process) fractures during the study. Circumstances surrounding the fracture, available X-ray and other diagnostic results and healing status were collected for the adjudication process.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||participants|||Number
1224134|NCT00708175|Other Pre-specified|Number of Participants Who Converted to Type 2 Diabetes Mellitus (T2DM)|Participants were considered to have converted to T2DM if there were ≥2 consecutive post-Baseline FPG measurements ≥126 mg/dL. Participants meeting criteria were tabulated and summarized by Study Period (Treatment and Follow-up). Conversion to T2DM during Treatment Period occurred if either both of the consecutive post-Baseline high FPG values, or the first of the 2 consecutive high values occurred on or before the first day off study drug. Conversion to T2DM occurred during the Follow-up Period if both consecutive high values occurred after at least 1 day after the Treatment Period.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||participants|||Number
1224135|NCT00708175|Other Pre-specified|Change in Fasting Plasma Glucose (FPG)|The change between the fasting plasma glucose value collected at each time frame indicated.|Baseline and Month 12; Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||mg/dL||Standard Error|Least Squares Mean
1224136|NCT00708175|Secondary|Percent Change From Month 12 to Month 18 in Bone Mineral Density in the Total Proximal Femur by DXA|The change in bone mineral density in the total proximal femur at month 18 relative to month 12. DXA is a means of measuring BMD through x-ray.|Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data.|||percent||Standard Error|Least Squares Mean
1224137|NCT00708175|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA)|The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 12.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data. If a valid pre-treatment scan was not available, the earliest (within 30 days) post-dosing scan was used as Baseline. There was one such participant for this endpoint.|||percent||Standard Error|Least Squares Mean
1224138|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 96|The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.|||cells/mm^3||Standard Deviation|Mean
1224139|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.|||cells/mm^3||Standard Deviation|Mean
1224140|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 96|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1224141|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1224142|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1224143|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1224144|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1224145|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1224146|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1224147|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1224150|NCT00708162|Secondary|Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1224151|NCT00708162|Secondary|Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1224152|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1224153|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1224154|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1224155|NCT00708162|Primary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1224156|NCT00708123|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"ITT population: All randomized participants who had a least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."|||µg*F/cm^2||Standard Error|Least Squares Mean
1224157|NCT00708123|Secondary|Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."|||%SMHR||Standard Error|Least Squares Mean
1224158|NCT00708123|Primary|Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the n per treatment group."|||%SMHR||Standard Error|Least Squares Mean
1224159|NCT00708110|Secondary|Number of Participants With the Emergence of Drug Resistance Mutations|The number of participants with the emergence (from Baseline) of drug resistance mutations at Day 11 was measured.|Baseline and Day 11|ITT(E) Population|||participants|||Number
1224160|NCT00708110|Secondary|Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Day 11|Median change from Baseline in CD4+ cell count was calculated as the Day 11 value minus the Baseline value.|Baseline and Day 11|Per-Protocol Population: all participants included in the ITT(E) Population, excluding those who had at least one major protocol deviation|||Cells per cubic millimeter (cells/mm^3)||Full Range|Median
1224161|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population|||Log10 copies/mL||Standard Deviation|Mean
1224162|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population|||Log10 copies/mL||Full Range|Median
1224197|NCT00708071|Secondary|Resolution of Edema as Assessed by Investigators.|Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
1224163|NCT00708110|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities|Clinical laboratory toxicities were graded according to the National Institutes of Allergy and Infectious Diseases (NIAID), Division of Acquired Immunodeficiency Syndrome (DAIDS). Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented only for Grade 3 and Grade 4 laboratory abnormalities. Clinical laboratory abnormalities included: increased glucose, lipase, decreased platelets, and triglycerides.|Screening; Days 1, 3, 7, and 10; and Follow-up (up to Study Day 21)|Safety Population|||participants|||Number
1224164|NCT00708110|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A 12-lead electrocardiogram (ECG) was performed by qualified personnel at the site after the participant had rested for at least 5 minutes in a semi-recumbent or supine position. If a QTc measurement of >=500 milliseconds (msec) was noted on a scheduled or unscheduled ECG, two additional ECGs were to be obtained within 5 minutes to confirm the abnormality. The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) ECG findings are presented here. The site determined if an ECG finding is significant or not. ECGs were obtained at Screening, Day 1 (pre-dose [twice] and then 1.0, 1.5, and 2.0 hours [hrs] post dose), Day 4 (pre-dose), Day 7 (pre-dose), Day 10 (pre-dose and then 1.0, 1.5, and 2.0 hrs post dose), Day 11 (prior to the 24 hr PK sample [pre lab]), and Follow-up.|Screening; Days 1, 7, 10, 11; and Follow-up (up to Study Day 21)|Safety Population. Only those participants who were available at the indicated time points were analyzed.|||participants|||Number
1224165|NCT00708110|Primary|Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10|Heart rate is the measure of heart beats per minute (bpm). Change in the mean heart rate from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population|||beats per minute||Standard Deviation|Mean
1224166|NCT00708110|Primary|Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10|Blood pressure measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Change in the mean blood pressure from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1224167|NCT00708110|Primary|Number of Participants Who Received the Indicated Concomitant Medications During the Study Period|Concomitant medications received during the study period are presented by generic term. Only those concomitant medications that were received by at least two participants are presented. “Multiple ingredient” is the term used in the statistical package for items that contain more than one active ingredient.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population. Only those participants who received a concomitant medication were analyzed.|||participants|||Number
1224168|NCT00708110|Primary|Number of Participants With Any Non-serious Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population: all participants who were randomized into the study with documented evidence of having received at least one dose of randomized treatment|||participants|||Number
1224169|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 10|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1224170|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following the Last Repeat Administration on Day 10|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analysed for the placebo group.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1224171|NCT00708110|Primary|Time to the Maximum Observed Concentration (Tmax) of GSK1349572 Following the Last Repeat Administration on Day 10|tmax is defined as the time to the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||Hours||Full Range|Median
1224172|NCT00708110|Primary|Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration|C0 is defined as the pre-dose concentration. Ctau is defined as the concentration at the end of the dosing interval. Cmin is defined as the minimum observed concentration during one dosing interval. Cmax is defined as the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1224198|NCT00708071|Secondary|Resolution of Ecchymosis as Assessed by Investigators|Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
1224173|NCT00708110|Primary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK1349572 Following the Last Repeat Administration on Day 10|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-tau) is defined as the area under the concentration-time curve over the dosing interval. Blood samples for PK analysis of GSK1349572 were obtained on Day 10at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1224174|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 1|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1224175|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following Dose Administration on Day 1|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1224176|NCT00708110|Primary|Time to Maximum Observed Concentration (Tmax) and Absorption Lag Time (Tlag) of GSK1349572 Following Dose Administration on Day 1|tmax is defined as the time to the maximum obsevered plasma concentration. Absorption lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. tlag was estimated based on PK sampling times of 0 (pre-dose), 0.5, 1, 1.5, 2 3, 4, 6, 8, 12, and 24 hours post-dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Hours||Full Range|Median
1224177|NCT00708110|Primary|Maximum Observed Plasma Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) of GSK1349572 Following Dose Administration on Day 1|Cmax is defined as the maximum observed plasma concentration, and C24 is defined as the concentration at 24 hours post dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, Cmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed in the placebo group.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1224178|NCT00708110|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) and Over 24 Hours (AUC[0-24]) of GSK1349572 Following Dose Administration on Day 1|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to24 hours. Blood samples for pharmacokinetic (PK) analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|Pharmacokinetic Summary (PKS) Population: participants (par.) with an evaluable profile of GSK1349572 on Day 10. Par. were excluded if they vomited within 2 hours of dosing on Day 10, missed more than one dose 2 days prior to Day 10, and took prohibited concomitant medication during the treatment period. No par. were analyzed in the placebo group.|||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1224179|NCT00708110|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL and <50 Copies/mL|The number of participants who achieved plasma HIV-1 RNA levels <400 copies/mL and <50 copies/mL through Day 11 was measured.|Day 11|ITT(E) Population|||participants|||Number
1224180|NCT00708110|Secondary|Plasma HIV-1 RNA Rate of Decline Over 10 Days|The rate of decline of plasma HIV-1 RNA levels from Day 1 to Day 11 was measured.|Day 1 to Day 11|ITT(E) Population|||Log10 copies/mL/day||90% Confidence Interval|Mean
1224181|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population|||Log10 copies/mL||Full Range|Median
1224182|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population|||Log10 copies/mL||Standard Deviation|Mean
1224183|NCT00708110|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11|Change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) was calculated as the Day 11 value minus the Baseline value. Blood samples for the measurement of HIV-1 RNA levels were obtained throughout the treatment period (Day 1 to Day 11).|Baseline (Day 1) and Day 11|Intent to Treat Exposed (ITT[E]) Population: all participants who met study criteria and were randomized into the study with documented evidence of having received at least one dose of randomized treatment and at least one post-baseline HIV-1 RNA measurement|||Log10 copies/milliliter (log10 copies/mL||Standard Deviation|Mean
1224184|NCT00708097|Secondary|Enamel Fluoride Uptake (Demineralized Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population: All randomized participants with at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.|||μg*F/cm^2||Standard Error|Least Squares Mean
1224185|NCT00708097|Secondary|Enamel Fluoride Uptake (Sound Enamel Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population:. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.|||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Least Squares Mean
1224186|NCT00708097|Secondary|Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
1224187|NCT00708097|Secondary|Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
1224188|NCT00708097|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
1224189|NCT00708071|Primary|Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period||Through Postoperative Day 14 (± 1)|Safety Data Set|||Adverse Events|||Number
1224190|NCT00708071|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)|Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another.|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
1224191|NCT00708071|Secondary|Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol|||Scores on a scale||Full Range|Median
1224192|NCT00708071|Secondary|Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol|||Scores on a scale||Full Range|Median
1224193|NCT00708071|Secondary|Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14|Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points|Postoperative Days 3, 7, 10, and 14|Per protocol|||mm||Full Range|Median
1224194|NCT00708071|Secondary|Participants With Hematoma/Seroma During the Study|Investigators assessed each side of the face for the presence of hematoma/seroma|Through Postoperative Day 14 (± 1)|Per protocol|||participants|||Number
1224195|NCT00708071|Secondary|Participants With Hematoma/Seroma|Investigators assessed each side of the face for the presence of hematoma/seroma|Days 0, 1, 3, 5, 7,10, and 14|Per Protocol|||Participants|||Number
1224196|NCT00708071|Secondary|Total Volume of Drainage on Each Side of the Face||24 hours postoperative|Per Protocol|||mL||Full Range|Median
1224199|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224200|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224201|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224202|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224203|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224204|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224427|NCT00706823|Primary|Time Required for Intubation|The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).|duration of intubation||||seconds||Standard Deviation|Mean
1224205|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224206|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224207|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224208|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224209|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224210|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4.~Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224211|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3|"Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Postoperative Day 3|Per Protocol|||Scores on a scale||Full Range|Median
1224218|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 14|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 14|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1224212|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224213|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224214|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224215|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224216|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224217|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1224451|NCT00706719|Primary|Semen Volume|Semen volume was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mL||Standard Deviation|Mean
1224219|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 10|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 10|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1224220|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 7|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 7|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1224221|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 5|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 5|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1224222|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 1|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 1|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1224223|NCT00708071|Primary|Visual Comparison of Ecchymosis at Postoperative Day 3|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 3|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1224224|NCT00708032|Primary|Papillary Conjunctivitis|Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.|12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
1224225|NCT00708032|Secondary|Subjective Overall Vision After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
1224226|NCT00708032|Secondary|Subjective Overall Comfort After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
1224227|NCT00708032|Secondary|Visual Acuity After 12 Months of Wear|Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||logMar||Standard Deviation|Mean
1224228|NCT00708032|Secondary|Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.|Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
1224229|NCT00708019|Secondary|Worst Pain Intensity Score|"Worst pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.~Change in worst pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks||||units on a scale||95% Confidence Interval|Mean
1224230|NCT00708019|Primary|Average Pain Intensity Score|"Average pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.~Change in average pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks||||units on a scale||95% Confidence Interval|Mean
1224231|NCT00707993|Secondary|Incidence of Glycosylated Hemoglobin Decrease From Baseline.|The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percentage of participants|||Number
1224232|NCT00707993|Secondary|Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%|The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percentage of participants|||Number
1224233|NCT00707993|Secondary|Change From Baseline in High Sensitivity C-reactive Protein|The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/L||Standard Error|Least Squares Mean
1224234|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Triglycerides)|The change in triglycerides measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1224235|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)|The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1224236|NCT00707993|Secondary|Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)|The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1224237|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Total Cholesterol)|The change in total cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1224238|NCT00707993|Secondary|Change From Baseline in Body Weight|The change in body weight measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||kg||Standard Error|Least Squares Mean
1224239|NCT00707993|Secondary|Homeostasis Model Assessment of Beta Cell Function|The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percent score of beta cell function||Standard Error|Least Squares Mean
1224240|NCT00707993|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||ratio||Standard Error|Least Squares Mean
1224241|NCT00707993|Secondary|Change From Baseline in Insulin|The change between the value of insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mcIU/mL||Standard Error|Least Squares Mean
1224242|NCT00707993|Secondary|Change From Baseline in Fasting Proinsulin|The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||pmol/L||Standard Error|Least Squares Mean
1224243|NCT00707993|Secondary|Change From Baseline in 2-hour Postprandial Glucose|The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set).|||mg/dL||Standard Error|Least Squares Mean
1224244|NCT00707993|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1224245|NCT00707993|Secondary|Incidence of Hyperglycemic Rescue|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis.|||participants|||Number
1224246|NCT00707993|Secondary|Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).|The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set).|||participants|||Number
1224247|NCT00707993|Secondary|Incidence of Hypoglycemia|Percentage of participants with at least one hypoglycemic episode during 52 week study.|On occurrence (up to 52 weeks).|Percentages based on the number of Safety Set participants in each treatment group.|||percentage of participants|||Number
1224248|NCT00707993|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit relative to baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1224249|NCT00707993|Primary|Change From Baseline in Glycosylated Hemoglobin at Week 52.|The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1224959|NCT00703391|Primary|Creatinine|Creatinine level greater than the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1224250|NCT00707980|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 52|Safety set with available data|||participants|||Number
1224251|NCT00707980|Secondary|Change From Baseline to the Final Visit in the Sheehan Disability Scale|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.|||scores on a scale||Standard Deviation|Mean
1224252|NCT00707980|Secondary|Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst).|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.|||scores on a scale||Standard Deviation|Mean
1224253|NCT00707980|Secondary|Change From Baseline in the Clinical Global Impression of Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1224254|NCT00707980|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1224255|NCT00707980|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1224256|NCT00707980|Secondary|Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1224257|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.|Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52|Safety set|||participants|||Number
1224258|NCT00707980|Primary|Number of Participants With Adverse Events (AEs)|"The intensity (severity) of each AE was defined as:~Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities.~Moderate: sufficiently uncomfortable to produce some impairment of normal activities.~Severe: incapacitating, preventing the patient from participating in normal activities.~The causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion."|From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)|Safety set|||participants|||Number
1224259|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval [QTc]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.|Weeks 4, 12, 24, 36 and 52|Safety set|||participants|||Number
1224260|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|Safety set|||participants|||Number
1224261|NCT00707980|Primary|Physical Examination Findings|"Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area.~Each system was assessed as normal or abnormal."|Baseline and Week 52|The safety set included all participants who enrolled and received at least 1 dose of open-label study medication. Results include data for participants with available data at each time point; 834 participants at Baseline and 524 participants at Week 52.|||participants|||Number
1224262|NCT00707967|Secondary|Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes|Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.|From Day 60 to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224263|NCT00707967|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1224264|NCT00707967|Secondary|Cell Count of CD4+ T Cells|CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.|At Day 0, 30, 60 and 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||T cells/cubic millimeter||Inter-Quartile Range|Median
1224265|NCT00707967|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.~For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
1224266|NCT00707967|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
1224267|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224268|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224269|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224270|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224271|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224272|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224273|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224274|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224275|NCT00707967|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224276|NCT00707967|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity|During the entire study period, from Day 0 up to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224277|NCT00707967|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224278|NCT00707967|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224279|NCT00707967|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1224280|NCT00707954|Secondary|Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin||18 days|||||||
1224281|NCT00707954|Secondary|Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr||19 days|||||||
1224282|NCT00707954|Primary|Safety: Adverse Events, Adverse Drug Reactions|In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.|19 days||||percentage of incidences|||Number
1224283|NCT00707915|Secondary|Clinical Global Impression (CGI)|The CGI rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The CGI - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. This will be performed at week 8.|Week 8||||units on a scale||Standard Deviation|Mean
1224284|NCT00707915|Secondary|Leeds Sleep Evaluation Questionnaire (LSEQ)|The LSEQ comprises 10 self-rating 100-mm-line analogue questions regarding changes in the quality of sleep and early morning behavior, following any given intervention. Scores range between 0 and 100. Scores beneath 50 indicate better sleep. This will be performed at week 8.|Week 8||||units on a scale||Standard Deviation|Mean
1224285|NCT00707915|Secondary|Critical Flicker Fusion Test (CFF)|The CFF threshold has been regarded as a functional measure of psychomotor function. Sub-threshold intermittent light is perceived as a flicker. If the frequency is gradually increased, the flicker becomes gradually less distinct until it is finally perceived as a continuous light (fusion threshold). The device (T.K.K.501c) provides luminance with a mean intensity of 500Lux±10% and a range of frequency of 20-60Hz. A change in the critical fusion frequency from baseline to week 8 will be recorded.|Baseline and week 8||||Hz||Standard Deviation|Mean
1224286|NCT00707915|Secondary|Clinical Stabilometric Platform (CSP)|CSP (ANIMA® GS-7, Tokyo) measures a total length of the trunk motion by varying the resistance applied to the platform for 30 seconds with eyes closed with feet together. Change in the total length of the trunk motion from baseline to week 8 will be recorded.|Baseline and week 8||||cm||Standard Deviation|Mean
1224287|NCT00707915|Secondary|A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8.|This brief test is to assess areas of cognitive functioning and profile impairment across domains with 12 subtests, including: List Learning, Story Memory, Figure Copy, Line Orientation, Digit Span, Coding, Picture Naming, Semantic Fluency, List Recall, List Recognition, Story Recall, and Figure Recall. This assessment is repeatable and not subject to practice effects. A total scale score ranges between 40 and 160; a higher score indicates better cognitive function. A change in the score between the baseline and week 8 is defined as a secondary outcome measure.|Baseline and week 8||||units on a scale||Standard Deviation|Mean
1224288|NCT00707915|Primary|Completion Rate|The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects|8 weeks||||percentage of successful completers|||Number
1224289|NCT00707863|Primary|17-item Hamilton Depression Rating Scale (HAM-D)|Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1224290|NCT00707759|Secondary|Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy||12 months|||||||
1224291|NCT00707759|Primary|Stimulation of Growth After 12 Months (Delta Z-score)||12 months||||units on a scale||Standard Deviation|Mean
1224292|NCT00707746|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1224293|NCT00707746|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224294|NCT00707746|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1224295|NCT00707746|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224296|NCT00707746|Other Pre-specified|Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||ratio||Standard Deviation|Mean
1224297|NCT00707746|Other Pre-specified|Percent Change From Baseline in the Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224298|NCT00707746|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1224299|NCT00707746|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224960|NCT00703391|Primary|Total Bilirubin|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||micromol/L||Standard Deviation|Mean
1224300|NCT00707746|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1224301|NCT00707746|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224302|NCT00707746|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1224303|NCT00707746|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224304|NCT00707746|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1224305|NCT00707746|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224306|NCT00707746|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1224307|NCT00707746|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224308|NCT00707746|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1224309|NCT00707746|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Inter-Quartile Range|Median
1224310|NCT00707746|Primary|Summary of Participants With Adverse Events|"The on-treatment time frame spanned the time during which the study drug was administered until the later of the primary efficacy time point and 14 days beyond the last study drug date.~Adverse events (AEs) were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug.~Severity was assessed as:~Mild-symptom barely noticeable to the patient or do not make the patient uncomfortable;~Moderate-symptom makes the patient uncomfortable, affects performance of daily activities;~Severe-symptom causes the patient severe discomfort, may cause cessation of treatment with the study drug.~Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Pre-treatment (prior to first dose), On-treatment (Day 1 to week 28), Post-treatment (Week 28-52)|Safety set of all randomized participants who received at least one injection of study drug.|||participants|||Number
1224311|NCT00707746|Primary|Low-density Lipoprotein Cholesterol at Baseline and the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1224312|NCT00707746|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1224313|NCT00707655|Secondary|Tumor Response Rate/ Complete or Partial Response||2 years||||participants|||Number
1224314|NCT00707655|Secondary|Best Overall Tumour Response|Best overall tumor response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|2 years||||participants|||Number
1224315|NCT00707655|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.|Overall study||||participants|||Number
1224316|NCT00707577|Primary|Weight Loss|Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program|1 year||||pounds||Standard Deviation|Mean
1224317|NCT00707486|Secondary|Incidence of Post Surgical Sequelae||1 week post surgery||||Percent of Participants|||Number
1224318|NCT00707486|Primary|Time to Hemostasis|This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.|Minutes After Application|Participants served as their own control thus the total amount of participants is reflected in both of the outcome measures.|||Minutes|Participants|Standard Error|Mean
1224319|NCT00707447|Secondary|Emotional Well-being/ Depression (CES-D)|"The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items scored from 0 to 3. Scores are summated, with raw score ranging from 0 to 25. Higher Scores idicate a higher depressive state.~Mean change in depression score (CES-D) after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1224320|NCT00707447|Secondary|Psychological Well-being (WHO-5)|"The WHO (Five) Well-being index consists of 5 items on the overall well-being over the last two weeks. Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25. Then the scores are transformed to 0-100 by multiplying by 4, with higher scores meaning better well-being.~Mean change in psychological well-being score (WHO-5) after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1224321|NCT00707447|Secondary|Eating Behavior (TFEQ) - Hunger|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale hunger consists of 14 Item with a minimum score of 0 and a maximum score of 14. Low scores indicate an eating behavior strongly depending on feelings of hunger.~Mean change in the TFEQ - hunger scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1224322|NCT00707447|Secondary|Eating Behavior (TFEQ) - Disinhibition|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale disinhibition consists of 16 Item with a minimum score of 0 and a maximum score of 16. High scores indicate an uninhibited eating behavior strongly depending on external cues.~Mean change in the TFEQ - disinhibition scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1224323|NCT00707447|Secondary|Eating Behavior (TFEQ) - Cognitive Restraint|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale cognitive restraint consists of 21 Item with a minimum score of 0 and a maximum score of 21. Low scores indicate an uninhibited eating behavior.~Mean change in the TFEQ - cognitive restraint scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1224324|NCT00707447|Secondary|Physical Exercise|Mean changes in physical exercise (in min/week) after 12 months|12 months||||minutes per week||Standard Deviation|Mean
1224325|NCT00707447|Secondary|Glucose Tolerance|Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months|12 months||||mg/dl||Standard Deviation|Mean
1224326|NCT00707447|Secondary|Fasting Glucose|Mean changes in fasting glucose (in mg/dl) after 12 month|12 months||||mg/dl||Standard Deviation|Mean
1224327|NCT00707447|Primary|Waist Circumference|Mean change in waist circumference (in cm) after 12 months|12 months||||cm||Standard Deviation|Mean
1224328|NCT00707447|Primary|Weight Change|Mean weight change (in kg) after 12 months|12 month|Intention to treat analysis (LOCF) and per protocol analysis for primary outcome and per protocol analysis for secondary outcome measures|||kg||Standard Deviation|Mean
1224339|NCT00707239|Other Pre-specified|Time to Reach Maximum Observed Serum Concentration (Tmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hrs||Full Range|Median
1224340|NCT00707239|Other Pre-specified|Maximum Observed Serum Concentration (Cmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1224329|NCT00707343|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques|"The ROC AUC represents the probability that tumor recurrence will be differentiated from radiation necrosis.~Positron Emission Tomography (PET) imaging methods using radiopharmaceutical agents F-18 fluorodeoxyglucose (FDG) and F-18 fluorothymidine (FLT) were used for analysis. For F-18 FDG, the maximum standardized uptake value (SUVmax) with correction for body weight was measured at suspicious area of lesion enhancement. The ratio of F-18 FDG SUVmax of the suspicious lesion to that of the SUVmean of a 1 cm diameter region of normal contralateral white matter was also measured (F-18 FDG ratio lesion: contralateral white matter). For F-18 FLT, the maximum standardized uptake value (SUVmax) was measured at suspicious area of lesion enhancement. Patlak graphical analysis was applied using the metabolite-corrected plasma input function to obtain voxel-wise estimates of the FLT metabolic influx parameter (F-18 FLT Kimax)."|30 minutes for FDG imaging, 70 minutes for FLT imaging acquisition; 2-33 months for lesion outcome confirmation||||Probability||95% Confidence Interval|Number
1224330|NCT00707239|Other Pre-specified|Duration of Intravenous Antibiotic Treatment, Hospital and Intensive Care Unit (ICU) Stay||Baseline up to Day 44 (30 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable for intravenous antibiotic treatment, hospital or ICU stay for each reporting group respectively.|||days||Full Range|Median
1224331|NCT00707239|Other Pre-specified|Time to Reach Half of the Maximum Observed Plasma Concentration and Time to Normalization of Concentrations (Tnorm) of Procalcitonin||Baseline up to Day 6|Data was not analyzed because there was no apparent change in procalcitonin concentration over time.|||hr||Full Range|Median
1224332|NCT00707239|Other Pre-specified|Maximum Observed Plasma Concentration of Procalcitonin (Cmaxpd) and Predicted Procalcitonin Plasma Concentration at 24 Hours (Cpd,24) and 48 Hours (Cpd,48)||Baseline up to Day 6|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1224333|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Microbiological Outcome|Microbiological response:Eradication=baseline isolate not present in repeat culture from original infection site;Presumed Eradication=clinical response of cure precluded availability of specimen for culture;Persistence=baseline isolate present in repeat culture from original infection site;Presumed Persistence=culture data not available for participants with clinical response of failure;Superinfection=culture from primary infection site had new pathogen not identified as baseline isolate, clinical response was failure. MIC=lowest drug concentration with no visible growth of microorganism.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Data was not analyzed because correlation analysis could not be performed due to insufficient number of participants for whom data for both microbiological outcomes and tigecycline concentration was available.|||ratio||Standard Deviation|Mean
1224334|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Clinical Outcome|Clinical response:Cure =Initial SSx improved;CXR improved/stable;no other antibiotic for pneumonia;no worsening/new SSx. Failure=Persistence/worsening SSx;no clinical improvement/initial improvement with worsening; other antibiotic;CXR progression;death >study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reason;death in 2 days after dose 1 for any reason or >2 days but before TOC visit for non-pneumonia reason. MIC=lowest drug concentration with no visible growth of microorganism. AUC(0-24)/MIC:reported for cure and failure/indeterminate.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1224335|NCT00707239|Other Pre-specified|Correlation of AUC (0-24) of Tigecycline With Nausea and Vomiting|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population PK analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Baseline up to Day 29 to 35 (15 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg*hr/mL||Standard Deviation|Mean
1224336|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Tigecycline|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg*hr/mL||Standard Deviation|Mean
1224337|NCT00707239|Other Pre-specified|Clearance (CL) of Tigecycline|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of serum from which drug can be completely removed per unit of time.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter/hr||95% Confidence Interval|Mean
1224338|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Tigecycline|AUC (0-12) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
1224341|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Potentially clinically significant ECG data: Non-first values greater than 240 millisecond (msec) with increase of greater than or equal to 10 percent (%) from baseline for PR interval; Non-first values greater than or equal to 120 msec for QRS interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for corrected QT (QTc) interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for QTc using Framingham formula (QTc F).|Baseline up to Day 14 or LDOT|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1224342|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Laboratory Examinations|Participants were evaluated for following laboratory parameters: albumin, alkaline phosphatase, amylase, urea (blood urea nitrogen [BUN]), total bilirubin, calcium, magnesium, carbon dioxide, international normalized ratio (INR), chloride, creatinine, glucose, lipase, potassium, phosphorus, aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, total protein, hemoglobin, hematocrit, white blood cells, eosinophils, neutrophils, lymphocytes, platelets, prothrombin time, prothrombin activity and partial thromboplastin time.|Baseline up to Day 24 to Day 35 (10 to 21 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1224343|NCT00707239|Other Pre-specified|Number of Participants Who Experienced Nausea or Vomiting||Baseline up to Day 29 to Day 35 (15 to 21 days after LDOT)|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1224344|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Participant Level Population at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure precluded the availability of a specimen for culture; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure; Superinfection = culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|Up to Day 24 to 35 (10 to 21 days after LDOT)|ME population included participants who met specified evaluability criteria for efficacy, had culture taken from the infected site before first dose of study medication and had at least 1 pathogen, and at least 1 baseline pathogen was susceptible to tigecycline and imipenem/cilastatin regimens.|||percentage of participants|||Number
1224345|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Pathogen Level Population at Test-of-Cure (TOC) Visit|Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for participants with a clinical response of failure; Indeterminate=unable to determine outcome for non-study drug/infection reasons; no baseline isolate; death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Microbiologically Evaluable (ME) population:participants who met evaluability criteria for efficacy, had culture taken from infected site before dose 1 of study drug, had at least (>=)1 pathogen, >=1 pathogen was susceptible to tigecycline, imipenem/cilastatin regimen; ‘n’ = those participants who had specified pathogen for each group respectively.|||percentage of participants|||Number
1224346|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Ventilator Associated Pneumonia (VAP) and Non-VAP Participants at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. 'n' is signifying those participants who were evaluable for this measure and included in VAP (suffering from VAP) and non-VAP group (not suffering from VAP) for each group respectively.|||percentage of participants|||Number
1224347|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Clinical Modified Intent-to-treat (c-mITT) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|c-mITT population included all participants who were randomly assigned to receive intravenous study medication and had clinical evidence of hospital-acquired pneumonia (HAP).|||percentage of participants|||Number
1224348|NCT00707239|Primary|Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR) improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after last day of therapy [LDOT])|CE population included those participants who met specified evaluability criteria for efficacy.|||percentage of participants|||Number
1224349|NCT00707174|Primary|The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants|Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.|24 months|All evaluable patients from both groups were compared|||participants|||Number
1224351|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 4|"Global evaluation, maximum relief, and overall relief scores for dose 4 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 4 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 48 hours or at time of rescue between 36 and 48 hours.|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1224352|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 3|"Global evaluation, maximum relief, and overall relief scores for dose 3 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 3 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 36 hours or at time rescue between 24 and 36 hours|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
1224353|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 2|"Global evaluation, maximum relief, and overall relief scores for dose 2 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 2 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 24 hours or at time of rescue between 12 and 24 hours|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1224354|NCT00707057|Secondary|Global Evaluation for Dose 1|"Global evaluation for dose 1, either at the time of rescue or at dose 2 (hour 12), whichever came first were summarized. At the 12-hour time point but before Dose 2, or within 1 minute of rescue medication use (if it occurred before hour 12), the subject was to provide a Global Evaluation of Dose 1 of study medication on an 11 point PI-NRS in response to the following command:~“Select the number that best describes how you would rate this medication as a pain-reliever (select one number only).” The range went from 0 (Very poor) to 10 (Excellent)."|At 12 hours after Dose 1 or at time of rescue|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1224355|NCT00707057|Secondary|Pain Relief and PID Scores at Individual Time Points for Dose 1|Pain relief and pain intensity difference (PID) scores at individual time points were summarized by descriptive statistics. The PID at each time point prior to dose 2 was derived by subtracting the pain intensity from the baseline pain intensity, so that a higher value was indicative of a greater improvement. Range of possible scores could be from 0 (no improvement) to 5 (greatest possible improvement)|24, 36, 48 hours after taking Dose 1|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1224356|NCT00707057|Secondary|Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1|Percentage of participants who require rescue medication (Lortab) at or prior to hour 8, hour 10 and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.|0-12 hours after taking Dose 1|Intention to treat (ITT)|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1224357|NCT00707057|Secondary|Duration of Relief After Dose 1|Duration of relief was defined as the time to treatment failure (i.e.,taking rescue medication, or withdrawing due to lack of efficacy) up to the 12-hour time point. For those withdrawing from the study due to lack of efficacy prior to taking dose 2 or rescue medication, time to treatment failure was the time from dose 1 to the last assesment time. For those discontinuing from the study for any other reason, the time to treatment failure was censored at the last assessment time.|Time to rescue or time of Dose 2 (up to 12 hours following dose 1)|Intention to treat (ITT)|||Minutes||Full Range|Median
1224358|NCT00707057|Secondary|Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID)|The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity from baseline pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval (scale ranges from 0 to 10; 0=no pain relief and 10= complete pain relief) was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval (e.g., 4-12 hours in case of SPID 4-12). Time weighted TOTPAR for each specified interval was similarly derived.|0-12 hours after Dose 1|Intention to treat (ITT)|||Time weighted units on a scale||Standard Deviation|Mean
1224359|NCT00707057|Secondary|"Percentage of Subjects Achieving Meaningful Relief as Indicated by the Time Recorded on the Second Stopwatch Following First Perceptible Relief"|"Percentage(%) of subjects with confirmed first perceptible relief and meaningful relief after dose 1. Subjects that achieved both first perceptible relief and meaningful relief within the time allotted. The assigned censored time for No Pain Relief is 240 minutes. Meaningful relief is a subjective definition, based on each subject's determination of pain"|Within 4 hours post Dose 1|Intention to treat (ITT)|||Percent of participants||95% Confidence Interval|Number
1224360|NCT00707057|Secondary|Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1|"Percentage (percentage of total) of subjects with first perceptible relief within 1 hour of Dose 1. The assigned censored time for No Pain Relief was 240 minutes."|Within 1 hour of Dose 1|Intention to treat (ITT)|||Percent of participants||95% Confidence Interval|Number
1224361|NCT00707057|Secondary|"Time to Confirmed Meaningful Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. To determine the exact moment that the subject began to notice pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed meaningful relief was achieved if both stopwatches were stopped within the 4 hour observation period, when both initial and meaningful relief were observed. Meaningful relief is a subjective definition, based on each subjects determination of pain."|Within 4 hours post Dose 1|Intention to treat (ITT)|||Minutes||Full Range|Median
1224362|NCT00707057|Secondary|"Time to Confirmed First Perceptible Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. In an effort to determine the exact moment that the subject began to obtain noticeable pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also later stopped the second stopwatch indicating meaningful relief. The assigned censored time for No Pain Relief is 240 minutes."|Within 4 hours post Dose 1|Intention to treat (ITT)|||Minutes||Full Range|Median
1224363|NCT00707057|Primary|Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours|Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation.|24, 36, and 48 hours|Intention to treat (ITT)|||participants|||Number
1224364|NCT00707057|Primary|Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale|"Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID).~An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation."|from baseline to 12 hours after dose 1|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1224365|NCT00707031|Other Pre-specified|Quality of Life: Change From Baseline in Patient's Satisfaction to Treatment (PAGI-QOL) at Week 24|PAGI-QOL: a 30–item self-administered questionnaire to measure health related QOL of patients with upper gastrointestinal disorders during past 2 weeks. Consists of 5 sub-scales. Each item rated on a 0-5 point Likert scale (0 [none of the time] to 5 [all the time]). Sub-scale score calculated by dividing sum of all items of subscale by number of items in the sub-scale. Total score calculated by taking mean of sub-scale scores. Sub-scale score and total score ranges from 0=none of the time (lowest score) to 5=all of the time (highest score) with lower scores indicating better QOL. The on-treatment period for this variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PAGI-QOL assessment during on-treatment period.|||units on a scale||Standard Error|Least Squares Mean
1224366|NCT00707031|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from hypoglycemia in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 116 weeks|Safety population included all randomized patients who received at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1224367|NCT00707031|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1224368|NCT00707031|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1224369|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1224384|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - FACE|Functional Alterations due to Changes in Elimination (FACE) is a 14-item questionnaire designed to evaluate the effects of changes in urinary and bowel elimination on daily functioning. It is scored out of 56, with higher scores reflecting poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
1224370|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1224371|NCT00707031|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1224372|NCT00707031|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1224373|NCT00707031|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute Change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1224374|NCT00706992|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years||||Participants|||Number
1224375|NCT00706992|Primary|Percentage of Participants With Immunologic Response|Percentage of participants with an immunologic response of >20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.|9/24/08-10/9/12|Arms 1-6 were evaluated in patients who received F5 cells. Arm 7 was not included in the evaluation because the participants did not receive F5 cells.The immunological response was measured for the total percentage of pts whom specimen was available for analysis. This was not captured per Arm. No statistically significant responses were observed.|||Percentage of participants|||Number
1224376|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At 6-month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
1224377|NCT00706979|Primary|A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|Serious quit attempt of >=24hrs, which fits the CDC’s definition of a quit attempt.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
1224378|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At any point during the study|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
1224379|NCT00706979|Primary|A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
1224380|NCT00706966|Secondary|Testosterone Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||ng/dL||Standard Deviation|Mean
1224381|NCT00706966|Secondary|Dihydrotestosterone (DHT) Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||ng/dL||Standard Deviation|Mean
1224382|NCT00706966|Secondary|Total PSA Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 for the 6-month Mean(SD) levels.|||ng/mL||Standard Deviation|Mean
1224383|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - SQLI|The Spitzer Quality of Life Index (SQLI) is a validated five-item questionnaire evaluating global HRQL. Activity, daily living, health, support of family and friends, and outlook are each rated on a 3-point scale (0 to 2), with total score ranging from 0-10, with lower score indicating poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to 6 months; thus, n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
1224961|NCT00703391|Primary|Creatine Kinase (CK)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||IU/L||Standard Deviation|Mean
1224385|NCT00706966|Secondary|Symptom Indices Over Time - IIEF-5|The International Index of Erectile Function (IIEF-5) is an abridged five-item version of the original IIEF 15-item questionnaire designed to evaluate erectile function, based on a definition arrived at by the National Institutes of Health Consensus Panel. Each of 5 questions about erectile function over the past 6 months is scored by the patient from 1 (severe dysfunction) to 5 (little or no dysfunction). The IIEF-5 is scored from 5 to 25, with lower scores indicating erectile dysfunction: 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
1224386|NCT00706966|Secondary|Symptom Indices Over Time - IPSS|IPSS (The International Prostate Symptom Score) is a symptom index based on seven questions concerning urinary symptoms (1 Incomplete emptying, 2 Frequency, 3 Intermittency, 4 Urgency, 5 Weak Stream, 6 Straining, 7 Nocturia) for which the patient chooses one out of six answers indicating increasing severity of the particular symptom, ranging from 0 (Not at all) to 5(Almost always). The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).|Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
1224387|NCT00706966|Secondary|Adverse Events Indicative of Safety of Dutasteride|Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.|Baseline, 1, 3, and 6 months||||adverse events|||Number
1224388|NCT00706966|Primary|Change in Extent of Cancer|Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, primary comparisons were made between the 1-month and 6-month scans.|1 month, 6 months|One participant withdrew from the study|||participants|||Number
1224389|NCT00706914|Other Pre-specified|Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)|FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
1224390|NCT00706914|Other Pre-specified|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)||Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
1224391|NCT00706914|Other Pre-specified|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)|The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
1224392|NCT00706914|Primary|Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores|Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Units on a scale||95% Confidence Interval|Mean
1224393|NCT00706914|Primary|Change From Baseline in Weekly Average Nocturnal Symptom Scores|Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Units on a scale||95% Confidence Interval|Mean
1224394|NCT00706901|Secondary|Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Days of drug use||Standard Deviation|Mean
1224395|NCT00706901|Primary|Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Number of 12-step sessions attended||Standard Deviation|Mean
1224396|NCT00706901|Primary|Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Number of treatment sessions||Standard Deviation|Mean
1224397|NCT00706901|Primary|Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Standard alcohol drinks||Standard Deviation|Mean
1224398|NCT00706901|Primary|Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)|||Days of binge drinking||Standard Deviation|Mean
1224399|NCT00706901|Primary|Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)|||Days Using Alcohol||Standard Deviation|Mean
1224400|NCT00706849|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
1224401|NCT00706849|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1224402|NCT00706849|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1224403|NCT00706849|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
1224404|NCT00706849|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||ratio||Inter-Quartile Range|Median
1224405|NCT00706849|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1224406|NCT00706849|Other Pre-specified|Very Low Density Lipoprotein at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
1224407|NCT00706849|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1224408|NCT00706849|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
1224409|NCT00706849|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1224410|NCT00706849|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
1224411|NCT00706849|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1224412|NCT00706849|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1224413|NCT00706849|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
1224414|NCT00706849|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1224415|NCT00706849|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
1224416|NCT00706849|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1224417|NCT00706849|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
1224418|NCT00706849|Primary|LDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1224419|NCT00706849|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of Baseline||Standard Deviation|Mean
1224420|NCT00706836|Secondary|To Evaluate the Effects of an Anxiolytic Drug Versus Placebo on Eye Blink Startle Response at Rest and During Emotional Stimuli (Anxiety Potentiated Startle, APS) as Well as on Clinical Scales.||Week 1, 2, 3|||||||
1224421|NCT00706836|Primary|Effect of Pregabalin (Two Doses) Versus Placebo|Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.|Week 1, 2, 3 (Cross-over Design)|Cross-over design, complete data available for all participants. Total number of participants in study is 16; all subjects received all 3 arms of treatment in randomized order.|||% signal change L amygdala + anticipn||Standard Error|Mean
1224422|NCT00706823|Secondary|Number of Attempts|The number of attempts taken to place the device|Before intubation||||participants|||Number
1224423|NCT00706823|Secondary|Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization|When the fiberoptic scope was placed in the gastirc drain tube of the i-gel, if the esophageal mucosa was visible and the stomach was readily accessible, then placement was considered succussful.|after intubation|Only the -gel has a gastric drainage tube--the uLMA does not. Thus, only those receiving the i-gel were assessed for this measure.|||participants|||Number
1224749|NCT00705367|Primary|Short-term Period: Mean Heart Rate|Vital signs measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||beats per minute||Standard Deviation|Mean
1224428|NCT00706810|Secondary|Median Progression-free Survival Rates of the Treatment Population.|Response and progression will be evaluated in this study using measurements from the MRI/CT scans. Measurements will be made of the image slice with the largest cross sectional area. Two orthogonal measures will be made to determine maximal AP and lateral dimensions. Progression of disease will be defined as a greater than 25% increase of largest cross sectional area by two orthogonal measurements, taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|31 months||||months||Full Range|Median
1224429|NCT00706810|Primary|Number of Participants Experiencing Serious Adverse Events Including But Not Limited to Hospitalizations, Deaths Related to Treatment, or Other Incapacitating Conditions.|Adverse Events assessed in accordance with CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.|two years||||participants|||Number
1224430|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on scale||Standard Deviation|Mean
1224431|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health Index|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on scale||Standard Deviation|Mean
1224432|NCT00706797|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)|Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224433|NCT00706797|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)|Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 12, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224434|NCT00706797|Secondary|Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period|Mean daily dose of corticosteroids to manage flare-ups (temporary increases in corticosteroid dose or use of intra-articular steroids) during treatment period. Daily dose of equivalent prednisone derived in mg/day: oral corticosteroids: 5 mg of prednisone = 5 mg of prednisolone = 25 mg of cortisone = 20 mg of hydrocortisone = 4 mg of methylprednisolone = 4 mg of triamcinolone = 2mg of paramethasone = 0.75 mg of betamethasone = 0.75 of dexamethasone = 0.3 of cortivazol.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||mg||Standard Deviation|Mean
1224435|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 90% (ACR90) Response|American College of Rheumatology 90% (ACR 90) response: responder = ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224436|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|American College of Rheumatology 70% (ACR70) response: responder = ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR) . Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224437|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|American College of Rheumatology 50% (ACR50) response: responder = ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224438|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|American College of Rheumatology 20% (ACR20) response: responder = ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224452|NCT00706719|Primary|Motile Total Sperm Count|Motile total sperm count was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||millions sperm||Standard Deviation|Mean
1224439|NCT00706797|Secondary|Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria|Response to treatment assessed by EULAR response criteria. Participants were characterized as good, moderate, or non-responders based on both Disease Activity Score (DAS) level attained and change in DAS. Good response defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders = participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >5.1. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224440|NCT00706797|Secondary|Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and participant’s assessment of general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission. DAS28 response of >0.6 defined as decrease in DAS28 >0.6 (change in DAS28 < -0.6).|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224441|NCT00706797|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224442|NCT00706797|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.60)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224443|NCT00706797|Secondary|Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using Visual Analog Scale (VAS); range 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 square root (√) (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.1=higher disease activity; <3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (change in DAS28 < -1.2).|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1224444|NCT00706797|Secondary|Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52|Radiographic non-progression determined based on TSS change <0.5 using the dichotomous response Yes / No. The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52, Last observation carried forward (LOCF)|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants||95% Confidence Interval|Number
1224445|NCT00706797|Secondary|Change From Baseline in Joint Space Narrowing at Week 52|Joint space narrowing score (a component of the modified TSS) is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
1224446|NCT00706797|Secondary|Change From Baseline in Erosions at Week 52|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
1224447|NCT00706797|Primary|Change From Baseline in Modified Total Sharp Score (TSS) at Week 52|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|Modified intent-to-treat (mITT) population including all participants with an erosion at randomization confirmed by the blinded expert assessor, received at least 1 dose of subject treatment, and had data for randomization and 1 post randomization X-ray. Efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
1224448|NCT00706784|Primary|Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion||8 hours||||pg/ml||Standard Deviation|Mean
1224449|NCT00706719|Secondary|Follicle Stimulating Hormone (FSH) Levels|FSH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mIU/mL||Standard Deviation|Mean
1224450|NCT00706719|Secondary|Luteinizing Hormone (LH) Levels|LH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mIU/mL||Standard Deviation|Mean
1224453|NCT00706719|Primary|Sperm Concentration|Total sperm concentration was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||millions sperm/mL||Standard Deviation|Mean
1224454|NCT00706706|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)|Safety population included those participants who had taken at least one dose of the study drug.|||Percent chance of survival||95% Confidence Interval|Number
1224455|NCT00706706|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.|||Weeks||95% Confidence Interval|Median
1224456|NCT00706706|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Per protocol (PP) population included those participants who had the disease under study, measurable disease and an adequate baseline disease assessment and had taken at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1224457|NCT00706706|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.|||Weeks||95% Confidence Interval|Median
1224458|NCT00706654|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
1224459|NCT00706654|Secondary|Percentage of Responders up to Week 38|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
1224460|NCT00706654|Secondary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse||Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
1224461|NCT00706654|Primary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26|A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline to Week 26|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
1224462|NCT00706641|Secondary|Increase in Cas3 Expression|Cas3 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
1224463|NCT00706641|Secondary|Reduced Ki-67 Expression|Ki-67 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
1224464|NCT00706641|Secondary|Post-Cystectomy Pathologic Stage|Tumor Node Metastasis (TNM) Staging. This system classifies tumors by size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M) T0=No evidence of primary tumor, Tis=Carcinoma in situ, and T1, T2, T3, T4=Increasing size and/or local extension of the primary tumor, TX=Not assessed N0=No Regional lymph node metastases, N1, N2, N3=Increasing number or extent of regional lymph node involvement, NX=not assessed M0=No distant metastases, M1=Distant metastases present|Staged Post-Cystectomy and dasatinib treatment||||percentage of particpants||95% Confidence Interval|Number
1224465|NCT00706641|Secondary|Pathologic Complete Response (pCR) Rate|Pathologic complete response (pCR) rate is defined as no residual evidence of muscle-invasive disease at cystectomy (< pT0).|24 months|23 participants completed treatment and underwent radical cystectomy.|||participants|||Number
1224467|NCT00706641|Secondary|Grade 3/4 Toxicities|Report grade 3/4 toxicities during treatment with dasatinib prior to radical cystectomy in patients with muscle invasive transitional cell carcinoma of the bladder.|Time of consent through 30 days after treatment discontinuation|24 patients received treatment, 1 patient ineligible due to small cell histology after starting dasatinib treatment and was not evaluable.|||percentage of particpants|||Number
1224468|NCT00706641|Primary|Feasibility|Feasibility for this trial is defined as at least 60% (>=14 of 23) of patients completing study therapy in the absence of Dose Limiting Toxicity (DLT)|From enrollment to completion of radical cystectomy|All patients who completed dasatinib|||participants|||Number
1224469|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Combination Therapy|"Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment (C12,14 for BIBF1120 ; C24,7 and C24,14 for BIBW2992)~C12,14: plasma concentration at 12 hours Day 14"|Day7, Day 14|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1224470|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Monotherapy|Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment|Day 15, Day 29 and Day 57|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1224471|NCT00706628|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set|||percentage of participants|||Number
1224472|NCT00706628|Secondary|Incidence and Worst Intensity of Adverse Events With Grading According CTCAE|Incidence and worst intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set|||percentage of participants|||Number
1224473|NCT00706628|Secondary|Overall Survival (Time to Death)|Overall survival (time to death) was calculated in days from baseline to the date of reporting of death. Time is expressed in Median number of days.|start of treatment until 28 days after end of treatment (Up to 52 weeks)|FAS|||days||95% Confidence Interval|Median
1224474|NCT00706628|Secondary|Time to Progression|"Time from first administration of study drug until disease progression according to composite endpoint.~Time is expressed in Median number of days."|start of treatment until end of the treatment (Up to 48 weeks)|FAS|||days||95% Confidence Interval|Median
1224475|NCT00706628|Secondary|Duration of RECIST Response|"Time from first observation of response (PR, CR, confirmed or unconfirmed) until progression according to RECIST (version 1.0) or death.~Duration is expressed in Median number of days."|Up to 48 weeks|FAS (RECIST evaluable set)|||days||Inter-Quartile Range|Median
1224476|NCT00706628|Secondary|Overall Objective Response by RECIST Criteria (Version 1.0) (Complete Response [CR] or Partial Response [PR]) for Patients With Measurable Disease at 12, 24, 36 and 48 Weeks|Objective response is defined as a Complete or Partial response Complete response [CR] for Target lesions: Disappearance of all target lesions. Complete response [CR] for Non- target lesions: Disappearance of all non-target lesions and normalization of tumour marker level Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|12, 24, 36 and 48 weeks|FAS (RECIST evaluable set)|||percentage of participants|||Number
1224477|NCT00706628|Secondary|RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks|RECIST (version 1.0) tumour progression rate at 12, 24, 36, and 48 weeks was calculated based on the occurrence of new lesions, or an increase in the sum of the longest lesion diameters of at least 20%.|12, 24, 36, and 48 weeks|FAS (RECIST evaluable set); RECIST evaluable set, which consisted of patients who had RECIST measurable disease at baseline.|||percentage of participants|||Number
1224478|NCT00706628|Secondary|Time to PSA Progression|"Time to PSA progression through 48 weeks was calculated as the number of days from first administration of study drug to the first time that there was an increase of 50% from the PSA nadir, provided the absolute increase was at least 5 ng/mL.~Time is expressed in median number of days."|Start of treatment until end of treatment (Up to 48 weeks)|FAS|||days||95% Confidence Interval|Median
1224479|NCT00706628|Secondary|Duration of PSA Response|"Duration of PSA response was calculated from the time of first 50% decline in PSA (compared to baseline) until the time at which there was an increase of 50% from the PSA nadir, provided that the absolute increase was at least 5 ng/mL. The increase had to be confirmed by a second consecutive measurement that was at least 50% above the nadir. If the PSA never showed a 50% increase over the nadir value, then the patient was censored at the last PSA measurement.~Duration of PSA response expressed in median number of days."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS|||days||Inter-Quartile Range|Median
1224480|NCT00706628|Secondary|Number of Patients Showing Prostate Serum Antigen (PSA) Response|"PSA response was evaluated according to the PSAWG guidelines. All patients achieving a fall in PSA of ≥50% from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria for PSA response. The confirmatory value had to be at least 50% lower than the baseline value, but could be higher than the original drop in PSA (first PSA value).~However, the confirmatory value could not be 50% higher than the first PSA value. If it was ≥50% higher than the first PSA, another sample was taken to determine if response had been achieved."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS|||percentage of participants|||Number
1224498|NCT00706550|Primary|IgG Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine||||Micrograms/ml||Full Range|Geometric Mean
1224481|NCT00706628|Secondary|Progression Free Rate at 24 and 48 Weeks|"PFR is defined as a composite endpoint for disease progression.~If patients met one of the following criteria they were counted as having progressive disease (PD):~Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria~Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)~Disease progression according to RECIST version 1.0"|24 weeks and 48 weeks|"Full analysis set (FAS), which consisted of all patients who received at least~1 dose of study medication and for whom progression status could be determined at 12 weeks."|||percentage of participants||95% Confidence Interval|Number
1224482|NCT00706628|Primary|Progression Free Rate (PFR) at 12 Weeks|"PFR is defined as a composite endpoint for disease progression.~If patients met one of the following criteria they were counted as having progressive disease (PD):~Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria~Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)~Disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0"|12 weeks|Modified full analysis set(mFAS): Patients who received at least 1 dose of study medication and for whom progression status could be determined at 12 weeks,excluding patients who discontinued treatment before 12 weeks for reasons other than PD.|||percentage of participants||95% Confidence Interval|Number
1224483|NCT00706589|Primary|Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)|The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.|10 week|ITT (Intention-To-Treat)analysis|||units on a scale||Full Range|Mean
1224484|NCT00706589|Secondary|1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.||10 weeks|||||||
1224485|NCT00706563|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1224486|NCT00706563|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1224487|NCT00706563|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.~Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever"|During the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
1224488|NCT00706563|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects unprotected at pre-vaccination and with available results|||subjects|||Number
1224489|NCT00706563|Primary|Serconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|At Day 21||||factor|||Number
1224490|NCT00706563|Primary|Number of Serconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|At Day 21||||subjects|||Number
1224491|NCT00706563|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|At Day 0 and 21||||subjects|||Number
1224492|NCT00706563|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|At Day 0 and 21||||subjects|||Number
1224493|NCT00706563|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|At Day 0 and 21||||titer||95% Confidence Interval|Geometric Mean
1224494|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.|One-month post-vaccine||||Titers||Full Range|Geometric Mean
1224495|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.|Baseline||||Titers||Full Range|Geometric Mean
1224496|NCT00706550|Primary|IgM Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine||||Micrograms/ml||Full Range|Geometric Mean
1224497|NCT00706550|Primary|Immunoglobulin M (IgM) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline||||Micrograms/ml||Full Range|Geometric Mean
1224499|NCT00706550|Primary|Immunoglobulin G (IgG) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline||||Micrograms/ml||Full Range|Geometric Mean
1224500|NCT00706485|Secondary|Marginal Failure.|Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.|up to 10 years|Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.||||||
1224501|NCT00706485|Secondary|Number of Participants With Local Control|Local failure is defined as: extension of the tumor margin[s] in any direction at least 5 mm beyond that present on the pre-treatment imaging studies or the appearance of -tumor in tissues previously scored as sites of sub-clinical disease. Local control is absence of local failure.|at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10||||participants|||Number
1224502|NCT00706485|Primary|Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use||At time of procedure||||participants|||Number
1224503|NCT00706446|Secondary|Asthma-related Quality of Life||1 year|Data was not collected for secondary outcomes due to study termination.||||||
1224504|NCT00706446|Secondary|Symptom-free Days||1 year|Data was not collected for secondary outcomes due to study termination.||||||
1224505|NCT00706446|Secondary|Exhaled NO (Nitric Oxide)||1 year|Data was not collected for secondary outcomes due to study termination.||||||
1224506|NCT00706446|Secondary|FEV1 (Forced Expiratory Volume)||1 year|Data was not collected for secondary outcomes due to study termination||||||
1224507|NCT00706446|Primary|Number of Patients With Asthma Exacerbation||1 year||||Participants|||Count of Participants
1224508|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 10 (6 Weeks after Final PDT)|ITT observed|||particpants|||Number
1224509|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
1224510|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 7 (Week 9)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 7 (Week 9)|ITT observed|||participants|||Number
1224511|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 5 (Week 6)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 5 (Week 6)|ITT observed|||participant|||Number
1224512|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 3 (Week 3)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 3 (Week 3)|ITT observed|||participants|||Number
1224513|NCT00706433|Secondary|Oozing/Vesiculation/Crusting 48 Hours After PDT #1|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|48 hours after PDT #1|ITT observed|||participants|||Number
1224514|NCT00706433|Secondary|Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 10 (6 Weeks after Final PDT)|ITT observed|||participants|||Number
1224531|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - during light treatment)|ITT observed|||participants|||Number
1224515|NCT00706433|Secondary|Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
1224516|NCT00706433|Secondary|Scaling and Dryness at Visit 7 (Week 9)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 7 (Week 9)|ITT observed|||participants|||Number
1224517|NCT00706433|Secondary|Scaling and Dryness at Visit 5 (Week 6)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 5 (Week 6)|ITT observed|||participants|||Number
1224518|NCT00706433|Secondary|Scaling and Dryness at Visit 3 (Week 3)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 3 (Week 3)|ITT observed|||participants|||Number
1224519|NCT00706433|Secondary|Scaling and Dryness 48 Hours After PDT #1|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|48 hours after PDT #1|ITT observed|||participants|||Number
1224520|NCT00706433|Secondary|Stinging/Burning at Visit 10 (6 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 10 (6 Weeks after Final PDT)|ITT observed|||participants|||Number
1224521|NCT00706433|Secondary|Stinging/Burning at Visit 9 (3 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
1224522|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - post light treatment)|ITT observed|||participants|||Number
1224523|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - during light treatment)|ITT observed|||participants|||Number
1224524|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - prior to light treatment)|ITT observed|||participants|||Number
1224525|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - before study drug application)|ITT observed|||participants|||Number
1224526|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - post light treatment)|ITT observed|||participants|||Number
1224527|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - during light treatment)|ITT observed|||participants|||Number
1224528|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - prior to light treatment)|ITT observed|||participants|||Number
1224529|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - before study drug application)|ITT observed|||participants|||Number
1224530|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - post light treatment)|ITT observed|||participants|||Number
1224962|NCT00703391|Primary|Aspartate Aminotransferase (AST)|AST level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1224532|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - before light treatment)|ITT observed|||participants|||Number
1224533|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - before study drug application)|ITT observed|||participants|||Number
1224534|NCT00706433|Secondary|Stinging/Burning 48 Hours Post PDT #1|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|48 hours post PDT #1|ITT observed|||participants|||Number
1224535|NCT00706433|Secondary|Stinging/Burning at Baseline - Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - post light treatment|ITT observed|||participants|||Number
1224536|NCT00706433|Secondary|Stinging/Burning at Baseline - During Light|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - during light|ITT observed|||participants|||Number
1224537|NCT00706433|Secondary|Stinging/Burning at Baseline - Before Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - before light treatment|ITT observed|||participants|||Number
1224538|NCT00706433|Secondary|Edema 6 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|6 weeks after final PDT|ITT observed|||participants|||Number
1224539|NCT00706433|Secondary|Edema 3 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|3 weeks after final PDT|ITT observed|||participants|||Number
1224540|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - post light treatment)|ITT observed|||participants|||Number
1224541|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Prior to Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - prior to light treatment)|ITT observed|||participants|||Number
1224542|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - before study drug application)|ITT observed|||participants|||Number
1224543|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - post light treatment)|ITT observed|||participants|||Number
1224544|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Pre Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - pre light treatment)|ITT observed|||participants|||Number
1224545|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - before study drug application)|ITT observed|||participants|||Number
1224546|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - post light treatment)|ITT observed|||participants|||Number
1224613|NCT00706121|Other Pre-specified|Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||ercentage of participants in subgroup|||Number
1224547|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before light treatment)|ITT observed|||participants|||Number
1224548|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before study drug application)|ITT observed|||participants|||Number
1224549|NCT00706433|Secondary|Edema 48 Hours After PDT #1|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|48 hours after PDT #1|ITT observed|||participants|||Number
1224550|NCT00706433|Secondary|Edema at Baseline - Post Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - Post Light Treatment|ITT observed|||participants|||Number
1224551|NCT00706433|Secondary|Edema at Baseline - Pre Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - pre light treatment|ITT observed|||participants|||Number
1224552|NCT00706433|Secondary|Erythema 6 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|6 Weeks after Final PDT|ITT observed|||participants|||Number
1224553|NCT00706433|Secondary|Erythema 3 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|3 Weeks after Final PDT|ITT observed|||participants|||Number
1224554|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - post light treatment)|ITT, observed|||participant|||Number
1224555|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Pre Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - pre light treatment)|ITT observed|||participants|||Number
1224556|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - prior to study drug application)|ITT observed|||participants|||Number
1224557|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - post light treatment)|ITT, observed|||participants|||Number
1224558|NCT00706433|Secondary|Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Weeks 6 - pre-light treatment)|ITT, observed|||participants|||Number
1224750|NCT00705367|Primary|Short-term Period: MeanSystolic and Diastolic Blood Pressure|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||mm Hg||Standard Deviation|Mean
1224559|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - prior to study drug application)|ITT, observed|||participants|||Number
1224560|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - post light treatment)|ITT, observed|||participants|||Number
1224561|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre-light)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre-light)|ITT, observed|||participants|||Number
1224562|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre study drug application)|ITT, observed|||participants|||Number
1224563|NCT00706433|Secondary|Erythema 48 Hours After PDT #1|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|48 hours after PDT #1|ITT, observed|||participants|||Number
1224564|NCT00706433|Secondary|Erythema at Baseline - Post Light Treatment|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline - post light treatment|ITT observed|||participants|||Number
1224565|NCT00706433|Secondary|Erythema at Baseline (Pre-light)|"After solution application, prior to light treatment~﻿ Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema"|Baseline (pre-light)|ITT, observed|||participants|||Number
1224566|NCT00706433|Secondary|Hypopigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed|||participants|||Number
1224567|NCT00706433|Secondary|Hypopigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed|||participants|||Number
1224568|NCT00706433|Secondary|Hypopigmentation at Visit 7 (Week 9)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed|||participants|||Number
1224569|NCT00706433|Secondary|Hypopigmentation at Visit 5 (Week 6)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed|||participants|||Number
1224570|NCT00706433|Secondary|Hypopigmentation at Visit 3 (Week 3)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed|||participants|||Number
1224571|NCT00706433|Secondary|Hypopigmentation 48 Hours Post PDT #1|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|48 hours post PDT #1|ITT, observed|||participants|||Number
1224572|NCT00706433|Secondary|Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed|||participants|||Number
1224573|NCT00706433|Secondary|Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed|||participants|||Number
1224574|NCT00706433|Secondary|Hyperpigmentation at Visit 7 (Week 9)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed|||participant|||Number
1224575|NCT00706433|Secondary|Hyperpigmentation at Visit 5 (Week 6)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed|||participants|||Number
1224576|NCT00706433|Secondary|Hyperpigmentation at Visit 3 (Week 3)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed|||participants|||Number
1224577|NCT00706433|Secondary|Hyperpigmentation 48 Hours After PDT #1|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|48 hours after PDT #1|ITT, observed|||participants|||Number
1224578|NCT00706433|Secondary|Investigator Global Assessment of Acne Severity Successes|"Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.~﻿0 Clear skin with no inflam or non-inflam lesions~Almost clear; rare non-inflam lesions with no more than a few small inflam lesions~Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)~Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule~Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules"|Baesline and 6 weeks after final treatment|ITT LOCF|||participants|||Number
1224579|NCT00706433|Secondary|Change in Inflammatory Lesion Counts Relative to Baseline|change in lesion counts compared to baseline|Baseline and 6 weeks after final treatment|ITT LOCF|||change in lesion count||Standard Deviation|Median
1224580|NCT00706433|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|6 weeks after final treatment|ITT, observed|||participants|||Number
1224581|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 6 weeks after final treatment|ITT LOCF|||percent change in lesion count||Standard Deviation|Median
1224582|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT LOCF|||percent change in lesion count||Standard Deviation|Median
1224583|NCT00706433|Primary|Investigator Global Assessment of Acne Severity Successes|Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.|Baseline and 3 weeks after final treatment|ITT LOCF|||participants|||Number
1224584|NCT00706433|Primary|Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT analysis, LOCF|||change in lesion count||Standard Deviation|Median
1224585|NCT00706407|Primary|Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis|The correlation of the NIRS pattern itself (independent of Qmax and PVR) to BOO. We looked at if the use of the NIRS is a comparable predictor for BOO in patients who were obstructed and those who weren't. The goal of the NIRS is to provide a non-invasive means to diagnose BOO. According to the NIRS algorithm, a downward NIRS pattern related to a higher probability of obstruction and and upward pattern relates to a higher probability of non obstruction.|Assessed at 3 and 6 months, post operatively||||participants|||Number
1224614|NCT00706121|Other Pre-specified|Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||ercentage of participants in subgroup|||Number
1224586|NCT00706355|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression up to C2 D1|Efficacy analysis set included all enrolled participants who received the study treatment and had measurable disease at baseline.|||Percentage of participants||95% Confidence Interval|Number
1224587|NCT00706355|Secondary|Change From Baseline in Tumor Proliferation Using F-Fluoro-3'-Deoxy-3’-L-Fluorothymidine Positron Emission Tomography (FLT-PET) Imaging at Day 1 of Cycle 2|F-fluoro-3'-deoxy-3’-L-fluorothymidine positron emission tomography (FLT-PET) imaging was used to assess the tumor proliferation in RP2D cohorts. Results of the FLT-PET were scored according to the methods developed by the American College of Radiology Imaging Network (ACRIN).|Cycle 2 Day 1|Data was not analyzed due to insufficient number of participants enrolled.|||Standardized Uptake Value (SUV)||Standard Deviation|Mean
1224588|NCT00706355|Secondary|Apparent Oral Clearance (CL/F) for PF-04217903|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Liter/hr (L/hr)||Standard Deviation|Geometric Mean
1224589|NCT00706355|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to End of Dosing Interval (MRAUCtau)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to end of dosing interval (MRAUCtau).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Ratio||Standard Deviation|Mean
1224590|NCT00706355|Secondary|Accumulation Ratio (Rac) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Rac is obtained from AUCtau (Cycle 2 Day 1) divided by AUCtau (Cycle 1 Day 1). Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Ratio||Standard Deviation|Mean
1224591|NCT00706355|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval [AUC(0-tau)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the concentration-time profile from time zero to time tau (dosing interval), where tau is equal to 12 hours.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng*hr/mL||Standard Deviation|Geometric Mean
1224592|NCT00706355|Secondary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration [AUC(0-last)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng*hr/mL||Standard Deviation|Geometric Mean
1224593|NCT00706355|Secondary|Pre-dose Plasma Concentration (Ctrough) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
1224594|NCT00706355|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||hr||Full Range|Median
1224595|NCT00706355|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng/mL||Standard Deviation|Geometric Mean
1224596|NCT00706355|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1|The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1224597|NCT00706355|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLT includes Gr 2 elevated creatinine and acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable), Gr >= 3 non-hematological non-disease-related (NDR) toxicities (except alopecia, Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >= 7 days, febrile neutropenia, neutropenic infection, inability to deliver at least 80 percent of planned dose during Cycle 1 due to NDR adverse events.|Baseline up to 21 days after the start of each increased treatment dose|DLT analysis set: participants who received first cycle of study medication and did not temporarily or permanently discontinue from study medication or missed more than 3 consecutive days of PF-04217903 dosing for reasons other than DLTs within first cycle.|||Participants|||Number
1224598|NCT00706355|Primary|Recommended Phase 2 Dose (RP2D)||Baseline up to 21 days after the start of each increased treatment dose|Data was not analyzed due to insufficient number of participants enrolled.|||mg|||Number
1224599|NCT00706355|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.|Baseline up to 21 days after the start of each increased treatment dose|Analysis population included all enrolled participants who received at least 1 dose of the study treatment.|||mg|||Number
1224600|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24||24 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1224601|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12||12 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1224602|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24||24 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1224603|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12||12 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1224604|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6||6 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1224605|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2||2 weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1224606|NCT00706329|Primary|Close Belly Button or Umbilical Hernia|The study was terminated prematurely by the IRB. Results are not shared due to data integrity concerns. These concerns are outlined in an FDA warning letter.|After surgery, subjects will be followed at intervals of one month and six months from date of surgery.|||||||
1224607|NCT00706134|Secondary|Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.|Baseline to end of study (week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||mmHg||Standard Error|Least Squares Mean
1224608|NCT00706134|Secondary|Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||Ratio||Standard Error|Least Squares Mean
1224609|NCT00706134|Secondary|Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||mmHg||Standard Error|Mean
1224610|NCT00706134|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Response|Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.|Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||Percentage of participants|||Number
1224611|NCT00706134|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
1224612|NCT00706134|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
1224635|NCT00706004|Secondary|Serum Glucose||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1224615|NCT00706121|Other Pre-specified|Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||ercentage of participants in subgroup|||Number
1224616|NCT00706121|Other Pre-specified|Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||percentage of participants|||Number
1224617|NCT00706121|Secondary|Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||Participants|||Count of Participants
1224618|NCT00706121|Primary|Effect of Selenium on Occurrences of Multiple (>2) Adenomas||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
1224619|NCT00706121|Primary|Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence||From 1 year post randomization through study completion||||Participants|||Count of Participants
1224620|NCT00706121|Primary|Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo|Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia|From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
1224621|NCT00706121|Primary|Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
1224622|NCT00706095|Primary|Best Overall Response Per Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|throughout the study and up to 30 days after the last dose of study drug|ITT Population|||Number of Participants|||Number
1224623|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Maximum Observed Plasma Concentration (Cmax)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population|||ng/mL||Standard Deviation|Mean
1224624|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Area Under Concentration Time Curve From Zero to Infinity (AUC0-oo)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population|||ng*hr/mL||Standard Deviation|Mean
1224625|NCT00706030|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) of Neratinib in combination with vinorelbine in subjects with advanced solid tumors.|From Day 1 to Day 21.|Safety population of Study Part 1. Treated set including patients eligible for MTD determination.|||mg|||Number
1224626|NCT00706030|Secondary|Duration Of Response|Duration of response for subjects who had complete or partial response from first response to disease progression, death or last assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From start date of response to first PD/death, up to four years and six months.|Subjects in evaluable population who had CR or PR according to Independent Assessment.|||weeks||Full Range|Median
1224627|NCT00706030|Secondary|Progression-Free Survival|Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.|From first dose date to progression or death, up to four years and six months.|Evaluable population, independent assessment.|||weeks||95% Confidence Interval|Median
1224628|NCT00706030|Secondary|Clinical Benefit Rate|Percentage of participants with partial response (PR) or complete response (CR) or stable disease > 24 weeks by independent assessment for subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to four years and six months.|Safety population|||percentage of participants||95% Confidence Interval|Number
1224629|NCT00706030|Primary|Overall Response Rate|Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to four years and six months.|Safety population|||percentage of participants||95% Confidence Interval|Number
1224630|NCT00706004|Secondary|Serum Albumin||baseline and 4 weeks|Participants who completed the study|||g/dL||Standard Deviation|Mean
1224631|NCT00706004|Secondary|Serum Prealbumin||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1224632|NCT00706004|Secondary|Serum Vitamin E||baseline and 4 weeks|Participants who completed the study|||mg/L||Standard Deviation|Mean
1224633|NCT00706004|Secondary|Serum Vitamin A||baseline and 4 weeks|Participants who completed the study|||ug/dL||Standard Deviation|Mean
1224634|NCT00706004|Secondary|Serum Vitamin D||baseline and 4 weeks|Participants who completed the study|||ng/mL||Standard Deviation|Mean
1224647|NCT00706004|Secondary|Self Reported Adverse Effects at Each Study Visit|Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit.|During entire study period|Participants who completed the study|||participants|||Number
1224648|NCT00706004|Secondary|Body Mass Index||baseline, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||kg/m^2||Standard Deviation|Mean
1224649|NCT00706004|Secondary|Bristol Stool Scale Score|The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea.|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||scores on a scale||Standard Deviation|Mean
1224650|NCT00706004|Secondary|Patient Assessment of Constipation Symptoms|The Patient Assessment of Constipation – Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient’s assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4).|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||scores on a scale||Standard Deviation|Mean
1224651|NCT00706004|Primary|Number of Spontaneous Bowel Movements Per Week||2-week run-in period, 2-weeks of treatment, 4-weeks of treatment|Participants who completed the study|||bowel movements||Standard Deviation|Mean
1224652|NCT00705939|Secondary|Platelet Count||Platelet count at Baseline and Months 12, 24 and 36||||Platelets per cubic millimeter||Standard Deviation|Mean
1224653|NCT00705939|Secondary|Hemoglobin||Hemoglobin at Baseline and Months 12, 24 and 36||||mg/dL||Standard Deviation|Mean
1224654|NCT00705939|Other Pre-specified|Liver Volume Multiples of Normal (MN)|Liver volume measured by MRI. Normal liver volume is 25 mL/kg × body weight (kg).|Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI.|||Multiples of Normal Liver Volume||Standard Deviation|Mean
1224655|NCT00705939|Other Pre-specified|Spleen Volume Multiples of Normal (MN)|Spleen volume measured by MRI. Normal spleen volume is 2 mL/kg × body weight (kg)|Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.|||Multiples of Normal Spleen Volume||Standard Deviation|Mean
1224656|NCT00705939|Secondary|Liver Volume|Liver volume measured by MRI|Liver volume at Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI .|||mL||Standard Deviation|Mean
1224657|NCT00705939|Primary|Spleen Volume|Spleen volume measured by MRI|Spleen Volume at Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.|||mL||Standard Deviation|Mean
1224658|NCT00705874|Secondary|Pharmacokinetics||End of Study|||||||
1224659|NCT00705874|Secondary|Drug Safety||Ongoing|||||||
1224660|NCT00705874|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).~DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047:~Any nonhematologic toxicity > Grade 3 lasting > 3 days~Grade 4 thrombocytopenia~Grade 4 Anemia on the next scheduled dosing day~Grade 4 Neutropenia (lasting > than 5 days~Any febrile neutropenia (Grade 3 or 4))~Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity"|End of Study|Cohorts comprised 3 patients. When a patient experienced a treatment related toxicity qualifying as a DLT, up to 3 additional patients were to be enrolled at that dose. Patients who completed cycle 1 per protocol were evaluable.|||mg|||Number
1224661|NCT00705783|Secondary|Time to Discontinuation|Time to discontinuation was defined as the date of randomization to the date of study discontinuation.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
1224662|NCT00705783|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient’s condition at Baseline. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-I scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Deviation|Mean
1224663|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Negative Subscale Score|The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
1224793|NCT00704938|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module.|5 months||||Participants|||Number
1249846|NCT00513500|Secondary|Number of Children Who do Not Respond to Treatment for Pneumonia||one year|Based on number classified as having pneumonia. Analysis was per intention to treat|||participants|||Number
1224664|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Positive Subscale Score|The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
1224665|NCT00705783|Secondary|Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score|The severity of illness for each patient was rated using the CGI-S. To assess CGI-S, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-S scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Mean
1224666|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Total Score|The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS total scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
1224667|NCT00705783|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who stayed in Phase 4 for at least 6 months and had values for the specific PANSS items P1, G9, P3, P2,G5, N1, N4, and N6.|||Percentage of patients|||Number
1224668|NCT00705783|Secondary|Percentage of Responders|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat (ITT) population: All randomized patients. Two of the 269 patients in the ITT population did not attend the Last Visit at which this Outcome Measure was assessed and were not included in the analysis.|||Percentage of patients|||Number
1224669|NCT00705783|Secondary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria|This is the key secondary Outcome Measure.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
1224670|NCT00705783|Primary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse|A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
1224671|NCT00705757|Primary|The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.|"Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity.~Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement."|one year|Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans.|||L*a*b*||Standard Error|Mean
1224672|NCT00705718|Secondary|Secondary Endpoint - Effectiveness Evaluation|"The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System.~Stent Graft migration through 12 months~Stent Graft Patency through 12 months~All stent Graft Endoleaks at 1-month, 6-months, and 12-month~Secondary Procedures to correct Type I and type III Endoleaks through 12 months~Secondary Endovascular Procedures through 12 months~Technical Observations through 12 months"|12 months|Number of subjects enrolled in the study arm|||percentage of evaluable subjects|||Number
1224673|NCT00705718|Primary|Primary Effectiveness Endpoint (Treatment Success)|"Treatment success is defined as Technical success and the following:~Freedom from AAA diameter increased, defined as >5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month~Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months~Freedom from aneurysm rupture through 12 months~Freedom from conversion to surgery through 12 months~Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months~Freedom from stent graft occlusion at 12 months"|12 months|The number of evaluable subjects for ths endpoint.|||participants|||Number
1224674|NCT00705718|Primary|Primary Effectiveness Endpoint (Technical Success)|Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.|Intra-operatively|The Technical Success of the Endurant Bifurcated arm was based on obtaining information for the first 121 evaluable subjects available in the clinical study.|||participants|||Number
1224675|NCT00705718|Secondary|Secondary Endpoints - Safety Evaluation|"The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System.~Aneurysm-Related Mortality through 12 months~All-Cause Mortality with 30 days~All-Cause Mortality within 12 months~Major Adverse Events through 12 months~Adverse Events through 12 months~Unanticipated Adverse Device Events~Serious Adverse Events (SAEs) As reported at the time of the data cut off.~Device Related Adverse Events~Procedure Related Adverse Events~Adverse Events (excluding SAEs)"|12 months|Number of subjects enrolled in the study arm|||percentage of evaluable participants|||Number
1224676|NCT00705718|Primary|Major Adverse Events Within 30 Days of Index Procedure|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.~All-Cause Mortality~Bowel Ischemia~Myocardial Infarction~Paraplegia~Procedural Blood Loss > or equal to 1000 cc~Renal Failure~Respiratory Failure~Stroke"|30 days||||percentage of participants|||Number
1224677|NCT00705718|Primary|Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.~All-Cause Mortality~Bowel Ischemia~Myocardial Infarction~Paraplegia~Procedural Blood Loss > or equal to 1000 cc~Renal Failure~Respiratory Failure~Stroke"|30 days (Safety)|Freedom from Major Adverse Events within 30 Days of Implant|||percentage of participants|||Number
1224678|NCT00705679|Primary|Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events|This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm.|Throughout study, up to 2.5 years|All participants randomized (intention-to-treat).|||participants|||Number
1224679|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
1224680|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
1224681|NCT00705679|Primary|Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
1224682|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
1224963|NCT00703391|Primary|Alanine Aminotransferase (ALT)|ALT level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1224683|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
1224684|NCT00705679|Primary|Person-years of Follow-up of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
1224685|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
1224686|NCT00705679|Secondary|Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product|The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure.|Throughout study, up to 2.5 years|Resistance testing was successfully completed on plasma from 301/312 HIV-1 seroconverters while on study product. 11 participants did not have a resistance result due to no stored plasma, insufficient copies of HIV-1 RNA for extraction, or PCR amplification failure.|||participants|||Number
1224687|NCT00705679|Primary|Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
1224688|NCT00705679|Primary|Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
1224689|NCT00705666|Primary|The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).||Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.|For the 48 week treatment period, the analysis did not separate Genotype 1 (G1) from Genotype 4 (G4) or others. Of the 789 participants, 8 were excluded from analysis (3 for lack of data; 5 because they were untreated).|||Participants|||Number
1224690|NCT00705653|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT).~Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047."|The MTD had to occur during cycle 1 of treatment||||mg|||Number
1224691|NCT00705653|Secondary|Preliminary Efficacy|As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.|Patients with non-missing overall response|||percentage (of participants)|||Number
1224692|NCT00705614|Secondary|Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months|The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with surgical procedure data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Surgical Procedures|||Number
1224693|NCT00705614|Secondary|Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay duration data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Days||Standard Deviation|Mean
1225768|NCT00697593|Primary|Hematology - White Blood Cell Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
1224694|NCT00705614|Secondary|Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Hospital Stays||Standard Deviation|Mean
1224695|NCT00705614|Secondary|Number of Participants With a Draining Fistula By Study Visit|The number of participants with a draining fistula was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with fistula status data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1224696|NCT00705614|Secondary|Work/Daily Activity Status Score By Study Visit|The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.|Up to 5 Years|The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
1224697|NCT00705614|Secondary|The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit|The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.|Up to 5 Years|The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
1224698|NCT00705614|Secondary|Participant Assessment of Overall Health Status By Study Visit|The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.|Up to 5 Years|The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
1224699|NCT00705614|Primary|Number of Participants With Lymphoproliferative Disorders/Malignancies|The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1224700|NCT00705614|Primary|Number of Participants With Hematologic Conditions|The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1224701|NCT00705614|Primary|Number of Participants With Demyelinating Neurological Disorders|The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1224702|NCT00705614|Primary|Number of Participants With New or Worsening Congestive Heart Failure|The number of participants with new or worsening congestive heart failure was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1224703|NCT00705614|Primary|Number of Participant Fatalities|The number of participant fatalities was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1224704|NCT00705614|Primary|Number of Participants With Infusion-Related Reactions/Hypersensitivity|The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1224705|NCT00705614|Primary|Number of Participants With Serious Infections|The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1224706|NCT00705575|Secondary|Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.|||Percentage|||Number
1224707|NCT00705575|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
1224708|NCT00705575|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 8|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
1224709|NCT00705575|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to end of study (Week 12)|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 12 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
1224710|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 360 Minutes After Injection (AUC[GIR{0-360}])|The area under glucose infusion rate curve from minutes (min) 0 to 360 after injection (AUC[GIR{0-360}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 360 during the clamp. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[360]) data.|||Grams per kilogram||Standard Deviation|Mean
1224711|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}])|The area the glucose infusion rate curve from minutes (min) 0 to 240 after injection (AUC[GIR{0-240}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 240 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose up to 240 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[240]) data.|||Grams per kilogram||Standard Deviation|Mean
1224712|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 180 after injection (AUC[GIR{0-180}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 180 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 180 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[180]) data.|||Grams per kilogram||Standard Deviation|Mean
1225218|NCT00701805|Secondary|Change in Mean iPTH||Every week from Baseline through Week 13 and every other week thereafter until Week 53|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||pg/mL||Standard Deviation|Mean
1224713|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}])|The area under the glucose infusion rate curve from minutes 0 to 120 after injection (AUC[GIR{0-120}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 120 during the clamp. Means were calculated using analysis of variance with fixed effects of participant, sequence within participant, treatment, and period.|Predose and up to 120 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-120]) data.|||Grams per kilogram||Standard Deviation|Mean
1224714|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 60 after injection (AUC[GIR{0-60}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment and every 3 min from min 0 through 60 during the clamp procedure. Means were calculated using analysis of variance with fixed of participant, sequence within participant, treatment, and period.|Predose and up to 60 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-60]) data.|||Grams per kilogram||Standard Deviation|Mean
1224715|NCT00705536|Secondary|Maximum Glucose Infusion Rate (GIR[Max])|Maximum glucose infusion rate (GIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable GIR(max) data.|||Milligrams per kilogram per minute||Standard Deviation|Mean
1224716|NCT00705536|Primary|Relative Bioavailability (Area Under the Curve [AUC] for Insulin + Recombinant Human Hyaluronidase [rHuPH20] / AUC for Insulin Alone)|"Relative bioavailability was determined by dividing the baseline-corrected geometric mean of the area under the curve (AUC) for insulin (ins) (Humalog or Humulin-R) with recombinant human hyaluronidase PH20 (rHuPH20) by the baseline-corrected geometric mean of the AUC for insulin alone (AUC[insulin+rHuPH20]/AUC[insulin]).~Bioavailability values for participants who received Humalog or Humulin-R and rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog + rHuPH20 or Humulin-R + rHuPH20 with evaluable relative bioavailability (AUC[insulin+rHuPH20]/AUC[insulin alone]) data.|||Ratio of AUC(ins+rHuPH20)/AUC(ins alone)||Standard Deviation|Mean
1224717|NCT00705536|Primary|Area Under the Concentration-Time Curve From Time 0 to Time to Reach Maximum Concentration (Tmax) for Serum Insulin With Recombinant Human Hyaluronidase PH20 (rHuPH20) (AUC[0-tmaxPH20])|Area under the concentration-time curve from time 0 to time to reach maximum concentration (tmax) for serum insulin (Humalog or Humulin-R) with recombinant human hyaluronidase (rHuPH20) (AUC[0-tmaxPH20]) for participants who received Humalog or Humulin-R and with rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment and every 3 min from min 0 through 48 for Stage 1 and, and every 3 min from min 0 through 68 for Stage 2 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 48 minutes postdose during Stage 1, or up to 68 minutes postdose during Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-tmaxPH20) data.|||Picomoles per liter times minutes||Standard Deviation|Mean
1224718|NCT00705536|Primary|Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t'])|Area under the serum concentration-time curve from time zero to the time required to reach endogenous plasma glucose levels (AUC[0-t']) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-t') data.|||Picomoles per liter times minutes||Standard Deviation|Mean
1224719|NCT00705536|Secondary|Time to Late Half-Maximal Effect for Glucose Infusion Rate (tGIR[late50%])|"Time to late half-maximal effect for glucose infusion rate (tGIR[late50%]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.~Because the study was only 360 minutes in duration, there was not sufficient time for regular human insulin to show an effect and therefore tGIR(late50%) could not be calculated for participants receiving Humulin-R alone."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, or Humulin-R + rHuPH20 with evaluable tGIR(late50%) data.|||Minutes||Standard Deviation|Mean
1224720|NCT00705536|Secondary|Time to Early Half-Maximal Effect for Glucose Infusion Rate (tGIR[early50%])|Time to early half-maximal effect for glucose infusion rate (tGIR[early50%]) for participants who were randomized to Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(early50%) data.|||Minutes||Standard Deviation|Mean
1224721|NCT00705536|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Time to maximal effect for glucose infusion rate (tGIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained every 3 minutes during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(max) data.|||Minutes||Standard Deviation|Mean
1224722|NCT00705536|Primary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable Cmax data.|||Picomoles per liter||Standard Deviation|Mean
1224723|NCT00705536|Primary|Time to Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (tmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tmax data.|||Minutes||Standard Deviation|Mean
1224724|NCT00705523|Secondary|Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.|The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking.|12 weeks of treatment, with a follow-up one month after treatment||||alcohol composite score||Standard Deviation|Mean
1224725|NCT00705523|Primary|Rate of Heavy Drinking Days Per Week.|Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).|12 weeks of treatment and one month follow-up||||rate of heavy drinking days per week||Standard Deviation|Median
1224726|NCT00705484|Primary|Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories|The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities.|Up to 5 years.|All enrolled participants. The Remicade and Standard Therapy Groups are the number of participants who enrolled at the start of the study (N=2239). The Switched to Remicade group are the subset of participants in the Standard Therapy Group, who switched to Remicade.|||Percentage of participants|||Number
1224727|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR|"Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 4, 8, 12, 16, 20|Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.|||Participants|||Number
1224794|NCT00704938|Primary|Clinical Response (Complete Response + Partial Response)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.|5 months||||Participants|||Number
1224728|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)|"Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 2, 4, 8, 12, 16, or 20|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Participants|||Number
1224729|NCT00705432|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL."|At FW 12 and at 72 weeks after randomization|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Participants|||Number
1224730|NCT00705432|Secondary|Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR."|At FW 24|Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.|||Percentage of participants|||Number
1224731|NCT00705432|Primary|Sustained Virologic Response (SVR) Rate|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR."|At Follow-up Week (FW) 24|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Percentage of participants|||Number
1224732|NCT00705406|Other Pre-specified|Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).|||Fold Change from Baseline||Standard Error|Mean
1224733|NCT00705406|Other Pre-specified|Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number of participants who had baseline susceptibility values to zanamivir, oseltamivir, and peramivir.|||nM||Standard Error|Mean
1224734|NCT00705406|Other Pre-specified|Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N is for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).|||Fold Change from Baseline||Standard Error|Mean
1224735|NCT00705406|Other Pre-specified|Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.|Baseline|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N was 113 for zanamivir susceptibility in the Placebo group.|||nM||Standard Error|Mean
1224736|NCT00705406|Other Pre-specified|Incidence of Influenza-related Complications|Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.|14 days|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||participants|||Number
1224795|NCT00704912|Secondary|Prevalence of Metabolic Syndrome||Baseline, 4 months||||participants|||Number
1224737|NCT00705406|Other Pre-specified|Time to Resolution of Fever|Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||hours||95% Confidence Interval|Median
1224738|NCT00705406|Other Pre-specified|Subject’s Severity of Illness (Score*Hours)|"A subject’s severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized.~The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21."|Information collected predose on Day 1 and then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||score*hours||Full Range|Median
1224739|NCT00705406|Secondary|Change in Influenza Virus Shedding|Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).|Baseline and Days 3, 4, 9|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||log10(TCID50/mL)||95% Confidence Interval|Median
1224740|NCT00705406|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected with Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A by culture or PCR.|||hours||95% Confidence Interval|Median
1224741|NCT00705367|Secondary|Long-term Period: Number of Participants With Abatacept-specific Antibodies|Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.|Day15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of abatacept and had an immunogenicity test result.|||Participants|||Number
1224742|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3X*ULN, or if preRX>ULN, use >4*preRX; GGT (/L): >*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; BUN (mg/dL):>2*preRX; sodium: <.95*LLN, >1.05*ULN, <.95* preRX if <LLN preRX, >1.05*preRX if >ULN preRX; >ULN if <LLN preRX, <LLN if >ULN preRX; potassium: chloride: calcium: phosphorous:|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1224743|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): <65 or >220. Glucose, fasting(mg/dL): <0.8*LLN or >1.5* ULN; if preRX<LLN, use <0.8*preRX or >ULN; if preRX>ULN, use >2.0*preRX or <LLN. Protein, total (g/dL): <0.9*LLN or >1.1*ULN; if preRX<LLN, use 0.9*preRX or >ULN if preRX >ULN, use 1.1*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX<LLN use <0.75*preRX. Uric acid (mg/dL): >1.5*ULN; if preRX>ULN use >2*preRX. Protein, urine: if missing preRX, use>=2; if >=4; if preRX=0 or 0.5, use >=2; if preRX=1, use >=3, or if preRX=2 or 3, use >= 4. Glucose, urine: if preRX missing, use >=2; if >=4, or if preRX=0 or 0.5 use >=2,or if preRX=1, use >=3, or if preRX=2 or 3 use >=4. Blood, urine: if preRX missing, use>= 2, or if >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3; if preRX=2 or 3 use >=4. WBC, urine (hpf): if missing preRX, use>= 2, or if >= 4, or if preRX =0 or 0.5 use >=2, or if preRX=1 use >=3, or if preRX=2 or 3 use >=4.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1224744|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): >3g/dL drop from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/L): <0.67*LLN or >1.5*ULN, or <100,000/mm^3 or if preRX<LLN, use <0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN, >1.25*ULN, <0.8*preRX if preRX <LLN or >1.2*preRX if preRX >ULN; >ULN if preRX <LLN, <LLN if >ULN preRX; neutrophils+bands (*10^3 c/uL): if value <1.00*10^3 c/uL; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL; monocytes (*10^3 c/uL): if value >2000/mm^3; basophils (*10^3 c/uL): if value >400/mm^3; eosinophils (*10^3 c/uL): if value> 0.750*10^3 c/uL|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1224745|NCT00705367|Primary|Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities|Laboratory tests consisted of complete blood count, chemistry, and urinalysis.|Screening and Days 1 and 2|All participants who received at least 1 dose of study drug|||Participants|||Number
1224746|NCT00705367|Primary|Short-term Period: Mean Temperature|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||Degrees Celsius||Standard Deviation|Mean
1224747|NCT00705367|Secondary|Maximum (Cmax) Plasma Concentration of Abatacept|Cmax is a drug's maximum, or peak, concentration observed after its administration.|Postdosing Day 1|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1224751|NCT00705367|Primary|Short-term Period: Number of Adverse Events (AEs) Related to Study Drug|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.|||Events|||Number
1224752|NCT00705367|Secondary|Minimum (Cmin) Plasma Concentration of Abatacept|Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.|Days 15, 29, 85, 169, 253 and 337|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.|||ug/mL||Standard Deviation|Mean
1224753|NCT00705367|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 infusion of abatacept during the open-label long-term extension period of the study.|||Participants|||Number
1224754|NCT00705367|Primary|Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1224755|NCT00705341|Secondary|Predictive Value of Methacholine Challenge Test for Phase 1|Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls|one time||||% predictive value||95% Confidence Interval|Number
1224756|NCT00705341|Primary|Methacholine Challenge Test Result for Phase 2|Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks|weeks 0, 4|There was a significant period effect in the percentage change in post diluent baseline (PC20) for high- and low-dose depending upon the order in which the doses were administered. In order to remove the effect of the order, we compared the high- and low-dose MCT results exclusively during the first cross over.|||mg/ml||Full Range|Geometric Mean
1224757|NCT00705289|Primary|Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.|At Baseline|All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates.|||Score on a scale||Standard Deviation|Mean
1224758|NCT00705289|Primary|Baseline Raw DAS28 by Country of Residence|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.|At Baseline||||Score on a scale||Standard Deviation|Mean
1224759|NCT00705289|Primary|Baseline Raw DAS28 by Gender|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.|||Score on a scale||Standard Deviation|Mean
1224760|NCT00705289|Primary|Baseline Raw DAS28 by Time Since Diagnosis|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.|At Baseline||||Score on a scale||Standard Deviation|Mean
1224761|NCT00705289|Primary|Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.|||Score on a scale||Standard Deviation|Mean
1224762|NCT00705263|Primary|Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.|Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.|After 4 weeks of treatment.|Patients with chronic hepatitis C treated with PegIntron pen plus Rebetol|||Satisfied Participants|||Number
1224796|NCT00704912|Secondary|Change in Weight|Change from baseline to end of the 4-month intervention.|Baseline, 4 months||||kg||95% Confidence Interval|Least Squares Mean
1224797|NCT00704912|Secondary|Ovulation Rate||Up to 4 months||||total number of ovulations|Clomiphene Treatment Cycles||Number
1224763|NCT00705250|Primary|Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL.|The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.|up to 3 years||||percentage of evaluable participants|||Number
1224764|NCT00705224|Secondary|Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline|Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study.|Week 12 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 210 participants demonstrated early virological response (N=158 and N=50). 2 participants of the 210 had missing values.|||Percentage of Participants|||Number
1224765|NCT00705224|Secondary|Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively).|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 29 participants demonstrated virological relapse (N=18 and N=11) and were therefore included in this analysis.|||Percentage of Participants|||Number
1224766|NCT00705224|Secondary|Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline|Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration.|Week 24 or 48 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 208 achieved RFT (N=156 and N=51) and were therefore included in this analysis. 1 participant of the 208 had missing values.|||Percentage of Participants|||Number
1224767|NCT00705224|Secondary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 181 achieved SVR (N=140 and N=40) and were therefore included in this analysis. 1 participant of the 181 had missing values.|||Percentage of Participants|||Number
1224768|NCT00705224|Primary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study|Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study.|||Percentage of Participants||95% Confidence Interval|Number
1224769|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3|Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 7|Study eye ITT population, subjects with non-missing data|||Score on a scale||Standard Deviation|Mean
1224770|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2|Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 3|Study eye, ITT population, non-missing data|||Score on a scale||Standard Deviation|Mean
1224771|NCT00705159|Primary|Change From Baseline in the Total Blepharoconjunctivitis Grade.|Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to 15 days|Study eye, ITT Population, Non-missing data|||Score on a scale||Standard Deviation|Mean
1224772|NCT00705146|Secondary|Pain|AUSCAN 3.1 pain subscale. Possible score range is 0 to 50. Lower scores indicate less pain. Change scores are reported (baseline to 4 weeks splint wear) for each of the two splints.|4 weeks|Pooled all participants for the phase they wore the hybrid, then comfort cool splints, respectively. Mean change scores are reported|||units on a scale||95% Confidence Interval|Mean
1224773|NCT00705146|Primary|Hand Function|Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.|4 weeks|Pooled participants from both arms from the phase they wore the hybrid splint, then from the phase they wore the comfort cool splint. Mean change scores are reported.|||units on a scale||95% Confidence Interval|Mean
1224774|NCT00705107|Secondary|Average Length of Treatment.||Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.||||weeks||Standard Deviation|Mean
1224775|NCT00705107|Primary|Number of Subjects Who Completed Treatment.||Assessed at the end of the 48-week treatment.|All participants|||Participants|||Number
1224776|NCT00705081|Primary|Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy|Achievement of LDL-C target levels as determined by physician|4-6 weeks after the first visit|All patients enrolled|||Participants|||Number
1224777|NCT00705081|Primary|Intensity of Adverse Events Reported|Intensity of adverse events reported after co-administration therapy|4-6 weeks after the first visit|All participants enrolled|||Participants|||Number
1224778|NCT00705081|Primary|Number of Participants Reporting Adverse Events|Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)|4-6 weeks after the first visit|All participants enrolled|||Participants|||Number
1224779|NCT00705016|Secondary|Safety - Number of Participants Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Safety population included all participants who were administered any dose of the trial medication, that is, cilengitide, cisplatin, 5-FU, or cetuximab.|||participants|||Number
1224780|NCT00705016|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of progressive disease (PD), or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1224781|NCT00705016|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 84 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1224782|NCT00705016|Secondary|Disease Control Rate|The disease control rate is defined as the percentage of participants having achieved confirmed CR, PR or stable disease (SD) as best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
1224783|NCT00705016|Secondary|Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of the participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
1224784|NCT00705016|Secondary|Overall Survival (OS) Time|The OS time is defined as the time from randomization to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1224785|NCT00705016|Primary|Progression-free Survival (PFS) Time: Investigator Read|The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Intention-to-treat (ITT) population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1224798|NCT00704912|Primary|Live Birth Rate||Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.||||participants|||Number
1224826|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.|The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.|Week 48|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
1224786|NCT00705003|Secondary|The Change From Baseline on the HAM-A at Week 6|"The 14-item HAM-A scale rates the patient’s level of anxiety based on feelings of anxiousness, tension, and depression; any phobias, sleep disturbance, or difficulty in concentrating; the presence of genitourinary, cardiovascular, respiratory, autonomic or somatic symptoms; and the interviewer’s assessment of the patient’s appearance and behavior during the interview. Each item is to be scored on a 5 point scale with 0 reflecting no symptoms and 4 reflecting symptoms of maximum symptom severity (Hamilton 1960).~The items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 56 units on a scale, where higher scores indicate more severe anxiety. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement."|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
1224787|NCT00705003|Secondary|The Change From Baseline in the Quick Inventory of Depressive Symptomatology – 16 Item Self-Report (QIDS-SR16) at Week 6|"The QIDS-SR16 is a 16 question, patient rated scale that assesses the 9 Diagnostic & Statistical Manual of Mental Disorders-IV-Text Revision criterion diagnostic symptom domains including sad mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease or increase in appetite or weight, & psychomotor agitation or retardation. Each item is measured on a scale of 0 to 3. To find total score, you enter:~highest score from items 1-4 (Sleep Items)~item 5 score~highest score from items 6-9 (appetite/weight)~item 10 score~item 11 score~item 12 score~item 13 score~item 14 score~highest score from items 15-16 (psychomotor) These 9 scores are summed to find total score. Total minimum score is 0 units on a scale & total maximum score is 27 units, where higher scores indicate more severe depression. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement"|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
1224788|NCT00705003|Secondary|The Change From Baseline in the IDS-C30 at Week 6|The Inventory of Depressive Symptomatology is a 30-item scale that assesses criteria including mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep, decrease/increase in appetite or weight, psychomotor agitation or retardation, diurnal mood variation, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. Items are scored on a 4 point scale with 0 reflecting no symptoms and 3 reflecting symptoms of maximum severity. The total score is calculated by summing the scores from 28 of the 30 items. Only one of items 11 or 12, and only one of items 13 or 14 are scored. The minimum score is 0 and the maximum score is 84. A score of 84 indicates maximum severity of depressive symptoms. Change from baseline is calculated as the baseline score minus the post-baseline score. A positive change indicates improvement.|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
1224789|NCT00705003|Secondary|The Change From Baseline in the CGI-S at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). The CGI-S is a sub-scale of the Clinical Global Impression. The Investigator was asked: “Considering your total clinical experience with patients with this particular population, please assign a rating to how mentally ill the subject is at this time.”~Possible responses include the following:~0: Not Assessed~Normal, not ill at all~Borderline mentally ill~Mildly ill~Moderately ill~Markedly ill~Severely ill~Among the most extremely ill patients. The change from baseline CGI-S score was calculated as the baseline CGI-S score minus the post-baseline CGI-S score, such that a positive change indicated an improvement from baseline."|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1224790|NCT00705003|Primary|The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). Specifically, it consists of two global subscales: Global Improvement (CGI-I) Severity of Illness (CGI-S)~The CGI-I was administered at Weeks 2, 4 and 6. The CGI-I evaluation was performed with instruction to “Rate the patient’s total improvement whether or not, in your judgment, it is due entirely to drug treatment.” The Investigator was asked “Compared to the patient’s condition at the Baseline visit, please assign a rating to how much the patient changed.” Responses for the CGI-I evaluation included the following categories:~0: Not Assessed~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Week 6|142 subjects were enrolled and randomized in the study. 8 of these subjects were randomized but never received study drug. Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
1224791|NCT00704964|Primary|Number of Participants With Adherence to Therapy According to Physician Approximation|Adherence was based on physiciant's clinical judgment.|Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3||||Participants|||Number
1224792|NCT00704964|Primary|Number of Participants With Biometrical Adherence to Therapy|Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.|Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3||||Participants|||Number
1224799|NCT00704847|Primary|Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||Units on a scale||Standard Deviation|Mean
1224800|NCT00704847|Secondary|• Bone & Cartilage Metabolism Biochemical Marker Change. • Questionnaires to Assess Function, Stiffness, Pain, Physical Activity, and Quality of Life • Knee Disease Progression Assessed by MRI||From baseline to 24 months|||||||
1224801|NCT00704847|Primary|Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||mm||Standard Deviation|Mean
1224802|NCT00704808|Primary|Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme||After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide|Intent-to-Treat population|||Months||Standard Error|Median
1224803|NCT00704769|Primary|General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments|Physicians judged the subjects as good, excellent, fair, or poor.|Minimum of 7 days after initiation of desloratadine||||Participants|||Number
1224804|NCT00704769|Primary|Adverse Events|An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.|Minimum of 7 days after initiation of desloratadine||||Participants|||Number
1224805|NCT00704730|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject’s time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.|Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT.|||% of participants|||Number
1224806|NCT00704730|Secondary|Biochemical Response Calcitonin (CTN) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject’s time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.|Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT.|||% participants|||Number
1224825|NCT00704418|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis(LOCF), ITT Population|||participants|||Number
1224853|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.||30 days||||Percentage of participants|||Number
1224807|NCT00704730|Secondary|Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined|For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.|From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.|The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders.|||months||95% Confidence Interval|Median
1224808|NCT00704730|Secondary|Objective Response Rate (ORR)|The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR|Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months.|The primary analysis Objective Response Rate (ORR) was performed among subset of Intent To Treat (ITT) subjects with measurable disease at baseline (N = 208 cabozantinib, N = 104 placebo) based upon response determined by Independent Radiology Committee (IRC.) Subjects without post-baseline adequate tumor assessments - counted as nonresponders.|||% of participants|||Number
1224809|NCT00704730|Secondary|Overall Survival (OS) With XL184 Compared With Placebo|Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.|The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.|Intent to treat (ITT) randomized to either XL184 or placebo|||months||95% Confidence Interval|Median
1224810|NCT00704730|Primary|Progression-Free Survival (PFS)|The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.|Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.|Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.|||months||95% Confidence Interval|Median
1224811|NCT00704717|Primary|Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.|The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen.|The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.||||Units on a scale||Standard Deviation|Mean
1224812|NCT00704535|Primary|Tolerability as Measured by Subject Self-assessment|Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment|28 days after Visit 1||||subjects|||Number
1224813|NCT00704535|Primary|Safety as Measured by Outcome of Adverse Events|To evaluate overall safety of ezetimibe as measured by outcome of adverse events|28 days after Visit 1||||adverse events|||Number
1224814|NCT00704535|Primary|Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event|To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event|28 days after Visit 1||||adverse event|||Number
1224815|NCT00704535|Primary|Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.|To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.|28 days after Visit 1||||adverse events|||Number
1224816|NCT00704535|Primary|Safety as Measured by Severity of Adverse Events as Determined by the Investigator|To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator|28 days after Visit 1||||adverse events|||Number
1224817|NCT00704535|Primary|Safety as Measured by Number and Type of Adverse Events.|Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.|28 days after Visit 1||||adverse events|||Number
1224818|NCT00704535|Secondary|To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)|Change in mean total cholesterol values|28 days after Visit 1|All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements|||mg/dL||Standard Deviation|Mean
1224819|NCT00704535|Primary|Safety as Measured by Number of Subjects With at Least One Adverse Event|Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event|28 days after Visit 1||||subjects|||Number
1224820|NCT00704522|Primary|Average Length of Treatment With PegIntron/Rebetol||After start of treatment|Number of participants who received study drug|||Weeks||Standard Deviation|Mean
1224821|NCT00704522|Primary|Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program||24 or 48 weeks (depending on genotype) and 24 weeks of follow up|All participants|||Participants|||Number
1224822|NCT00704496|Secondary|Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo|daytime sleepiness by subjective questionnaires|3 years|data disposed of and no longer in existence||||||
1224823|NCT00704496|Primary|Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo|sleep improvement by subjective questionnaires|3 years|data disposed of and no longer in existence||||||
1224824|NCT00704418|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses|Day 1|LOCF Analysis, ITT Population|||participants|||Number
1224827|NCT00704405|Secondary|Percentage of Participants Achieving cEVR|The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.|Up to Week 60|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. The 3 Vaniprevir 600 mg b.i.d. arms were combined in this analysis.|||Percentage of participants|||Number
1224828|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.|The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.|72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
1224829|NCT00704405|Primary|Number of Participants Discontinuing From Study Treatment Due to AEs|The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.|Up to 48 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.|||Number of participants|||Number
1224830|NCT00704405|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|Up to 73 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.|||Number of participants|||Number
1224831|NCT00704405|Primary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.|The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.|Up to 72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
1224832|NCT00704379|Secondary|Neuroimaging Variables (i.e., Fractional Anisotropy [FA] of Frontal White Matter Such as the Cingulate Gyrus)|"FA is a measured obtained from Diffusion Tensor Imaging, an image modality of Magnetic Resonance Imaging (MRI). FA is a unitless index. Range: 0 to 1. FA describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted or equally restricted in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. In the context of this study, FA measures the integrity of the cingulate gyrus white matter. Higher FA values reflect higher integrity of the cingulate gyrus white matter tract. Average FA values for the right and left cingulate gyri were summed.~One aim of this project was to identify predictors of the occurrence of mood disturbances during the first 6 months following TBI. The hypothesis for this aim was that patients who develop a mood or anxiety disorder six months after TBI present at baseline with lower FA of the cingulate gyrus than those who do not."|Baseline|Of the 94 participants randomized, only 61 participants had an MRI and were included in the analysis of this study aim.|||unitless index||Standard Deviation|Mean
1224833|NCT00704379|Secondary|Social Functioning Examination Total Score|The Social Functioning Examination (SFE) is a semi-structured interview that measures social functioning in areas such as interpersonal relationships, work adjustment, use of community resources and satisfaction with living environment. Range: 0 to 1. Higher scores denote lower levels of social functioning.|6 months after TBI|Out of the 80 participants who completed the trial, only 63 completed SFE at this evaluation time.|||units on a scale||Standard Deviation|Mean
1224834|NCT00704379|Secondary|Memory Function Composite|This outcome measures memory function and is a composite of five standardized scores: Brief Visuospatial Memory Test - Revised, Delayed Recall and California Verbal Learning Test, Short Delay Free Recall Number Correct and Discriminability, and Long Delay Free Recall Number Correct and Discriminability. Standardized scores (i.e., z-scores) for each test of this composite were obtained by subtracting the mean raw score of all participants to the raw score of each participant and dividing the result by the standard deviation of the raw scores of all participants. The composite score was obtained by averaging the z-scores of the four memory tests mentioned previously. Range: -3 to 3. Higher scores represent better memory function.|6 months following traumatic brain injury|Out of the 80 participants who completed the trial, only 61 completed all the tests necessary to calculate the composite score at this evaluation time.|||z-scores||Standard Deviation|Mean
1224835|NCT00704379|Secondary|Iowa Gambling Task Score|The Iowa Gambling Task (IGT) evaluates decision making ability. During IGT subjects have to choose between decks of cards which yield high immediate gain but larger future loss (i.e., long term loss), and decks which yield lower immediate gain but a smaller future loss (i.e., a long term gain). The task consists of four decks of cards: A, B, C, and D. The goal in the task is to maximize profit. Subjects are required to make a series of card selections. The decks A and B are long term loss decks and the decks C and D are long term gain decks. The IGT Score reported is the combination of the raw score for each deck combined in the following way: (C+D) - (A+B). The range for this score is: -100 to 100. Higher values of this score indicate better decision making ability.|6 months after TBI|Out of the 80 participants who completed the trial, only 64 completed IGT at this evaluation time.|||units on a scale||Standard Deviation|Mean
1224922|NCT00703729|Primary|Patient Reported Pain on Day 1|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1224836|NCT00704379|Secondary|Total Community Integration Questionnaire Scores|The Community Integration Questionnaire (CIQ) is intended as a brief, reliable measure of an individual’s level of integration into the home and community following traumatic brain injury. Total CIQ scores were used as the outcome measure. Range: 0 to 25. Higher scores indicate higher levels of integration into the home and community following TBI.|6 months after TBI|Out of the 80 participants who completed the trial, only 68 completed CIQ at this evaluation time.|||units on a scale||Standard Deviation|Mean
1224837|NCT00704379|Primary|Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI)|"Following the DSM-IV (now updated by the DSM-5), depressive disorders associated with TBI are categorized as Mood Disorder Due to Another Medical Condition with subtypes: 1) With major depressive-like episode (if the full criteria for a major depressive episode [MDE] are met) or 2) With depressive features (prominent depressed mood but full criteria for a MDE are not met); and 3) with mixed features (e.g. significant irritability, pressured speech and formal thought disorder).~On the other hand, bipolar and related disorders due to TBI are subdivided in: 1) with manic or hypomanic like episode; 2) with manic features; and 3) with mixed features.~A similar conceptual framework has been used to define Anxiety Disorder due to another Medical Condition, in this case, TBI. According to DSM-IV/DSM-5, such diagnosis can be made when, besides an evident pathophysiological relationship with TBI, panic attacks or generalized anxiety are the prominent features of the clinical presentation."|6 months after TBI||||weeks||Standard Error|Mean
1224838|NCT00704353|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)||through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)||||participants|||Number
1224839|NCT00704340|Secondary|Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak|"As determined from clinical diagnosis by one of the following methods:~CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 30 days post-operation~CSF leak confirmation by diagnostic testing within 30 days post-operation~CSF leak confirmation by clinical evaluation including physical examination of the surgical site within 30 days post-operation"|30 days||||percent of subjects||95% Confidence Interval|Number
1224840|NCT00704340|Secondary|Percentage of Subjects With Post-operative Surgical Site Infections||30 days||||percent of subjects||95% Confidence Interval|Number
1224841|NCT00704340|Primary|Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.|"Surgical Wound Complications;~Superficial incisional surgical site infection (SSI)~Deep incisional SSI~Organ/Space SSI~Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery~Poor wound healing~Central Nervous System Events;~Cerebrospinal Fluid (CSF) leak~Hydrocephalus~Bacterial meningitis~Aseptic meningitis~In addition, any complication related to the neurosurgical procedure that required unplanned intervention (i.e., minimally invasive procedures) or return to the operating room was counted."|30 days||||percent of subjects||95% Confidence Interval|Number
1224842|NCT00704184|Secondary|Mean Log Change From Baseline in HCV RNA|The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Log10 IU/mL||Standard Deviation|Mean
1224843|NCT00704184|Secondary|Number of Participants With ≥3-log10 Decrease in HCV RNA|The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Number of Participants|||Number
1224844|NCT00704184|Secondary|Number of Participants With ≥2-log10 Decrease in HCV RNA|The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Number of Participants|||Number
1224845|NCT00704184|Primary|Number of Participants Discontinuing From Study Therapy Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.|Day 1 to Day 28|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy|||Participants|||Number
1224846|NCT00704184|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.|Up to Day 42|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.|||Participants|||Number
1224847|NCT00704184|Primary|Percentage of Participants Achieving RVR|Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.|Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Percentage of Participants|||Number
1224848|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge|Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles|30 days|Analysis by grade of air leak.Grade 1= countable air bubbles, Grade 2= Stream of bubbles, Grade 3 = Coalesced bubbles.|||Percentage of participants|||Number
1224849|NCT00704171|Secondary|Duration of Hospitalization||30 days||||hours||Standard Deviation|Median
1224850|NCT00704171|Secondary|Duration of Chest Drainage||30 days||||hours||Standard Deviation|Median
1224851|NCT00704171|Secondary|Time From Skin Closure to Last Observable Air Leak.||30 days||||hours||95% Confidence Interval|Median
1224852|NCT00704171|Secondary|Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.|Success is defined as no presence of air leak intra-operatively.|Intra-operatively, time of study procedure||||Percentage of participants|||Number
1224854|NCT00704132|Primary|Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6|Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.|Baseline and Week 6|Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6.|||mg*hr/dL||95% Confidence Interval|Least Squares Mean
1224855|NCT00704028|Primary|The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)||Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer||||participants|||Number
1224856|NCT00703976|Secondary|2-year Overall Survival (OS)|Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.|2 years of follow-up after closing accrual||||percentage of participants||95% Confidence Interval|Number
1224857|NCT00703976|Primary|2-year Progression-free Survival (PFS)|Two-year PFS is an estimated percentage of participants without disease progression (locoregional or distant) at two years after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as: at least a 20% (and at least 5 millimeters) increase in the sum of the diameters of target lesions, or the appearance of one or more new lesions.|18 months to patient accrual and 2 years of follow-up after closing accrual.||||percentage of participants||90% Confidence Interval|Number
1224858|NCT00703963|Secondary|Mean Number of INR Tests Performed||baseline to 3 months||||INR tests||Standard Deviation|Mean
1224859|NCT00703963|Secondary|Mean Percentage of INR Tests Within the Therapeutic Range||baseline to 3 months||||percentage of tests||Standard Deviation|Mean
1224860|NCT00703963|Primary|Mean Percentage of Time in Therapeutic Range||baseline to 3 months||||percentage of time||Standard Deviation|Mean
1224861|NCT00703937|Primary|Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC|Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent|First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer||||participants|||Number
1224862|NCT00703924|Secondary|Rate of Relapse|"Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher’s exact test.~Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher’s exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable."|180 days||||Participants|||Count of Participants
1224863|NCT00703924|Secondary|Final Cure Rate by Subject of All Lesions|Final cure rate by subject was determined using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable.|180 days||||Participants|||Count of Participants
1224864|NCT00703924|Secondary|Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse|100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization.|180 days|Days to 100% re-epithelialization of index lesion. Volunteer Identification Number (VIN). VINs 17, 72, and 109 failed to meet 100% re-epithelialization|||Participants|||Count of Participants
1224865|NCT00703924|Primary|Safety of WR 279,396 (AEs and SAEs)|Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.|180 days|All solicited local and systemic AEs and SAEs including immediate and delayed reactions that occurred during this study are summarized.|||Adverse Events|||Number
1224866|NCT00703924|Primary|Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)|CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher’s exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. The Breslow-Day test was used to examine whether the effect of WR 279,396 varied between subgroups|180 days||||Participants|||Count of Participants
1224867|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1224868|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (All Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1224923|NCT00703729|Secondary|Use of Pain Medication on Day 1|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1224869|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1224870|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (All Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1224871|NCT00703911|Secondary|Adults' Health Related Quality of Life (Haemo-QoL-A): Overall Score|The adult Haemo-QoL-A is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of adult subjects above 16 years included in the study that completed the questionnaire at baseline and/or at discontinuation|||scores on a scale||Standard Deviation|Mean
1224872|NCT00703911|Secondary|Childrens' Health Related Quality of Life (Haemo-QoL): Overall Score|The Haemo-QoL is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of paediatric subjects age 4 to 16 (inclusive) included in the study that completed the questionnaire at baseline and/or at discontinuation|||scores on a scale||Standard Deviation|Mean
1224873|NCT00703911|Secondary|Overall Time to Cessation/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable.|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose, excluding bleed episodes treated with more than one dose for which > 24 hours between the 1st and 2nd dose was reported (bleed episodes with > 24 hours between 1st and 2nd rFVIIa dose likely reflects treatment of re-bleeding or prophylactic/maintenance dosing)|||minutes||95% Confidence Interval|Median
1224874|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||minutes||95% Confidence Interval|Median
1224875|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (All Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||minutes||95% Confidence Interval|Median
1224876|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (Spontaneous Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1224877|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (All Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1224878|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Symptom Relief (Spontaneous Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1224879|NCT00703911|Secondary|Percentage of Patients Reporting Satisfaction With Symptom Relief (All Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1224880|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (Spontaneous Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes. Excludes bleeds episodes with > 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing, and 2 bleed episodes categorised as CNS that would not meet criteria of mild to moderate spontaneous bleed episodes|||mcg/kg||Full Range|Median
1224881|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (All Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level. Excludes bleeds episodes with greater than 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing|||mcg/kg||Full Range|Median
1224882|NCT00703911|Secondary|Total Number of Injections (Spontaneous Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||injections||Inter-Quartile Range|Median
1224883|NCT00703911|Secondary|Total Number of Injections (All Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||injections||Inter-Quartile Range|Median
1224884|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (Spontaneous Bleed Episodes)|Effective pain relief at 3 different time points for spontaneous bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1224885|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (All Bleed Episodes)|Effective pain relief at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1224886|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (Spontaneous Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1224887|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (All Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1224888|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (Spontaneous Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1224889|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1224890|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1224891|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1224892|NCT00703885|Primary|Voxelwise Brain Imaging Data|Analysis of data not completed.|Post-Rx Administration|||||||
1224893|NCT00703885|Primary|Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing|Analysis not completed.|Same Day|||||||
1224894|NCT00703846|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the functional component, participants were asked to answer 15 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of the 12 question scores; total score ranges from 15 to 75.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1224924|NCT00703729|Primary|Patient Reported Pain on Day 0|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1224925|NCT00703677|Secondary|Geriatric Depression Scale(GDS)-15:Change From Baseline|The GDS-15 is a 15-item instrument used to screen for depression in the elderly. Subjects will be assessed at the Screening Visit and at Week 28.|28 weeks|||||||
1224895|NCT00703846|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the emotional component, participants were asked to answer 10 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of the 10 question scores; total score ranges from 10 to 50.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1224896|NCT00703846|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the symptomatic component, participants were asked to answer 7 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of the 7 question scores; total score ranges from 7 to 35.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1224897|NCT00703846|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1224898|NCT00703846|Secondary|Median Number of Flare Days|The median number of flare days for all participants was calculated based on data self-reported in diaries that participants kept during the study. The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare day is defined as a day on which flare signs and symptoms for seborrheic dermatitis (erythema, scaling, and pruritus of the target area) occurred.|From baseline through 52 weeks|Safety Analysis Set|||flare days||Full Range|Median
1224899|NCT00703846|Secondary|Median Number of Flares|The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare is defined as a clinical diagnosis and presentation of seborrheic dermatitis that shows as an erythematous, thin, scaly patch with a greasy sandpaper texture that varies depending on disease severity. Flares are commonly seen on the scalp, nasal folds, eyebrows, glabella, upper eyelids, retroauricular/external ear canal, and midchest areas.|From baseline through 52 weeks|Safety Analysis Set|||flares||Full Range|Median
1224900|NCT00703846|Secondary|Mean Change From Baseline in Investigator’s Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|"This seborrhoeic dermatitis-specific ISGA scale (range=0-4) is used to assess skin condition severity without considering changes over time (static). 0=clear, except for minor residual discoloration; 1-4=majority of lesions have average scaling/erythema scores of 1-4, respectively. 1=almost clear, occasional fine scale, faint erythema/barely perceptible plaque thickness; 2= mild, fine scale with light coloration/mild plaque elevation; 3=moderate, coarse scale with moderate red coloration/moderate plaque thickness; 4=severe, thick tenacious scale with deep coloration/severe plaque thickness."|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
1224901|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for pruritis ranges from 0 to 4; 0=No itching; 1=Minimal: rarely aware of itching; 2=Mild: only aware of itching at times; only present when relaxing; not present when focused on other activities; 3=Moderate: often aware of itching; annoying; sometimes disturbs sleep and daytime activities; 4=Severe: constant itching; distressing; frequent sleep disturbance; interferes with activities. Pruritus is defined as an itching/scratching sensation.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
1224902|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline in skin assessments for scaling was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for scaling ranges from 0 to 4; 0=Normal skin with rare fine scale; 1=Minimal: occasional fine scales over less than 10% of the lesions; 2=Mild: fine scales predominate; 3=Moderate: coarse scales predominate; 4=Severe: thick tenacious scales predominate. Scaling of skin is the loss of the outer layer of the epidermis in large, scale-like flakes.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
1224926|NCT00703677|Secondary|Frontal Assessment Battery (FAB): Change From Baseline|The FAB is a brief, 6-item instrument designed to assess executive function. Subjects will be assessed at baseline and at Week 28.|28 weeks|||||||
1250581|NCT00508027|Other Pre-specified|Change in Plasma Hs-CRP Levels|Change in plasma high sensitivity C-reactive protein levels in subjects treated with simvastatin|Baseline, 21 days||||mg/L||Standard Deviation|Mean
1224903|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or early termination) value minus the baseline value. The grading scale for erythema ranges from 0 to 4; 0=Normal skin without erythema; may have residual hyper/hypopigmentation; 1=Faint erythema; may have residual hyper/hypopigmentation; 2=Light red erythema; may have residual hyper/hypopigmentation; 3=Moderate red coloration; 4=Dusky to deep red coloration. Erythema was defined as redness of the skin caused by increased blood circulation in the capillaries found in the deeper layers of the skin.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
1224904|NCT00703846|Primary|Number of Participants With Any Adverse Event (AE)|"An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled Other (Non-Serious) Adverse Events."|From baseline through 52 weeks|Safety Analysis Set: all participants who had used the study product at least once|||participants|||Number
1224905|NCT00703820|Secondary|Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.||3 years after completion of therapy|||||||
1224906|NCT00703820|Secondary|Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.||3 years after completion of therapy|||||||
1224907|NCT00703820|Primary|Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry|MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.|Day 22 MRD measurement after one course of therapy|Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.|||Participants|||Count of Participants
1224908|NCT00703781|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop|Day 1|LOCF Analysis, ITT Population|||Participants|||Number
1224909|NCT00703781|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT)|||Participants|||Number
1224910|NCT00703729|Secondary|Use of Pain Medication on Day 7|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1224911|NCT00703729|Secondary|Use of Pain Medication on Day 6|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1224912|NCT00703729|Secondary|Use of Pain Medication on Day 5|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1224913|NCT00703729|Secondary|Use of Pain Medication on Day 4|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1224914|NCT00703729|Secondary|Use of Pain Medication on Day 3|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1224915|NCT00703729|Secondary|Use of Pain Medication on Day 2|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1224916|NCT00703729|Primary|Patient Reported Pain on Day 7|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1224917|NCT00703729|Primary|Patient Reported Pain on Day 6|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1224918|NCT00703729|Primary|Patient Reported Pain on Day 5|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1224919|NCT00703729|Primary|Patient Reported Pain on Day 4|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1224920|NCT00703729|Primary|Patient Reported Pain on Day 3|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1224921|NCT00703729|Primary|Patient Reported Pain on Day 2|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1224927|NCT00703677|Secondary|PSP-Quality of Life Scale (QoL):Change From Baseline|The PSP-QoL Scale is an instrument designed to assess mental and physical aspects of quality of life specifically in patients with PSP. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks|||||||
1224928|NCT00703677|Secondary|Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline|The UPDRS is a commonly used clinical rating scale to assess motor function in patients with parkinsonism. Subjects will be assessed at baseline and Weeks 5, 12, 20, and 28.|28 weeks|||||||
1224929|NCT00703677|Secondary|PSP Rating Scale Score: Change From Baseline|The PSP Rating Scale is a 28-item scale designed to assess the disability associated with PSP. The six functional categories assessed are: daily activities, behavior, bulbar function, oculomotor function, limb motor function, and gait/midline function. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks|||||||
1224930|NCT00703677|Secondary|Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity|Levels of beta-catenin and the ratio of phosphorylated GSK-3 beta to total GSK-3 beta will be measured at baseline and at Week 28|28 weeks|Due to the very small number of samples collected, samples were not analyzed.||||||
1224931|NCT00703677|Secondary|Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF|With inhibition of Glycogen Synthase Kinase (GSK)-3 beta, levels of BDNF may increase. BDNF levels will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed||||||
1224932|NCT00703677|Secondary|Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)|Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are characterized by hyperphosphorylation of tau. Lithium inhibits one of the kinases (GSK-3 beta) that phosphorylates tau; levels of tau phosphorylation will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed||||||
1224933|NCT00703677|Secondary|Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses between study visits were considered compliant.|28 weeks|All subjects were evaluated for compliance.|||Subjects|||Number
1224934|NCT00703677|Primary|Ability to Tolerate Lithium Carbonate|The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L.|28 weeks|One subject completed the full 28 week course of study drug; 13 subjects stopped drug early due to intolerability.|||Subject|||Number
1224935|NCT00703664|Secondary|Duration of Stable Disease|Median duration of stable disease per cohort.|Up to 9 years|All participants with stable disease.|||months||Full Range|Median
1224936|NCT00703664|Secondary|Duration of Partial Response|Median duration of response per cohort.|Up to 9 years|All participants with Partial Response.|||months||Full Range|Median
1224937|NCT00703664|Secondary|Progression-free Survival (PFS)|Median progression-free survival in months per cohort.|Up to 9 years|All evaluable participants at time of analysis. Cohort B was closed early due to lack of accrual.|||months||95% Confidence Interval|Median
1224938|NCT00703664|Secondary|Best Response|Number of participants per category: Partial Response (PR), Stable Disease (SD), Progressive Disease (PD). PR: Regression of measurable disease and no new sites. SD: Failure to attain Complete Response (CR), /PR or PD. Relapsed or Progressive Disease: Any new lesion or increase by ≥ 50% of previously involved sites from nadir.|Up to 9 years|All participants evaluable and available at time of assessment.|||Participants|||Count of Participants
1224939|NCT00703664|Primary|Overall Response Rate (ORR)|ORR: Complete Response (CR) + Partial Response (PR) assessed according to the Revised Response Criteria for Malignant Lymphoma.|Up to 9 years|All participants.|||percentage of participants|||Number
1224940|NCT00703534|Primary|Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary|Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)|Run-in period of 8-12 days and treatment period of 26-30 days|None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.|||participants|||Number
1224941|NCT00703508|Secondary|Determine in Which Genotype(s) Frequency of Ovulation Correlates With Improvement in Reduction in Total Testosterone and Insulin Sensitivity as Measured by the Matsuda Index.|Bivariate fit (RSquare with P values) of ovulation rate post treatment by change in total testosterone and Matsuda Index for each of the 3 genotypes (G/G, C/G, C/C)|9 months|Individuals that were lost to follow up had missing data on testosterone and OGTT (oral glucose tolerance testing) for Matsuda index.|||Correlation coefficient (r^2)|||Number
1224942|NCT00703508|Primary|Ovulation Rate Over Study Duration for STK11 Genotypes CC, CG and GG|Ovulations were determined by measurement of daily urine pregnanediol-3-glucuronide or weekly progesterone levels over 6-9 months of study duration for each participant. The ovulation rate was calculated as the number of confirmed ovulation events per months of study participation.|9 months||||ovulations/month||Standard Deviation|Mean
1224943|NCT00703508|Primary|Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G)|Responders were defined as those that had a doubling of baseline ovulation rate estimated by self-report of menstrual history.|9 months||||participants|||Number
1224944|NCT00703391|Primary|Renal Clearance of Drug From Plasma (CLR)|CLR following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||L/h||Full Range|Geometric Mean
1224945|NCT00703391|Primary|Terminal Half-life of Drug in Plasma (t1/2)|t1/2 following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||hours||Full Range|Median
1224946|NCT00703391|Primary|Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)|tmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||hours||Full Range|Median
1224947|NCT00703391|Primary|Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)|Cmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||nM||Full Range|Geometric Mean
1224948|NCT00703391|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))|AUC(0-12) following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||nM.h||Full Range|Geometric Mean
1224949|NCT00703391|Primary|FEV1 (Forced Expiratory Volume in the First Second)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||L||Standard Deviation|Mean
1224964|NCT00703339|Secondary|Pharmacokinetic (PK) Parameters After a Single Dose of Inhaled Treprostinil and Acute Hemodynamic Effects.|PK samples will be collected at frequent intervals up to 4 hours following single dosing . Hemodynamic parameters at 4 hours post dosing include heart rate, pulmonary arterial pressure, systemic arterial pressure, right atrial pressure, pulmonary capillary wedge pressure, mixed venous oxygen saturation and cardiac output.|acute|Insufficient enrollment, therefore no participants were analyzed.||||||
1224965|NCT00703339|Primary|Safety and Tolerability of Inhaled Treprostinil Sodium in Patients With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis,Reported as Number of Participants With Adverse Events|Safety and Tolerability evaluation include any observed or reported changes in vital signs, ECGs, clinical chemistry ,hematological or urinalysis, and any reported symptoms following a single dose administration on the day of dosing and up to the final visit 3-5 days later. Adverse events will be tabulated by total incidence and by individual patient, and the severity, causality and outcomes will also be documented. Each cohort of 4 patients will be fully evaluated as described before proceeding to the escalation to the next dose.|3-5 days|Insufficient enrollment, therefore no Participants were analyzed.||||||
1224966|NCT00703326|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and other NSAEs is located in the Reported Adverse Event module.|First dose to study completion (up to 49 months) plus 30-day safety follow-up|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1224967|NCT00703326|Other Pre-specified|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The overall percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals.|Baseline, prior to cycle 3 infusion, prior to cycle 5 infusion, onset of infusion reaction, resolution of reaction and 30 days following the event until data cutoff of 31-Mar-2013 (up to 31 months)|All randomized participants who received at least 1 dose of study drug with anti-IMC-1121B antibodies samples collected during the study.|||percentage of participants|||Number
1224968|NCT00703326|Secondary|Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns of breast cancer subscale (BCS) each with 6 or more items developed to measure problems specific to breast cancer symptoms plus additional items related to global QoL. Participants respond to each of the 36 questions on a 5-point scale from 0 (not at all) to 4 (very much) with a total scores range of 0-144. Higher scores indicate fewer symptoms and better HR-QoL.|Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 42 months)|A subset of Intent-to-Treat (ITT) Population: all randomized participants with a valid baseline and end of therapy assessments.|||units on a scale||Standard Deviation|Mean
1224969|NCT00703326|Secondary|Duration of Response|Duration of complete response (CR) or partial response (PR) measured from time criteria were first met for CR or PR until first date of progressive disease (PD) or death from any cause defined using Response Evaluation Criteria in Solid Tumor (RECIST 1.0); by Investigator assessment. CR defined as disappearance of all target and non-target lesions. PR defined as ≥30% decrease in sum of longest diameter (LD) of target lesions and no progression in non-target lesions. PD defined as ≥20% increase in LD sum of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of ≥1 new lesion(s). Participants who did not relapse or die censored at day of last radiographic tumor assessment. If death or PD was after ≥2 missing radiographic visits, censoring was at date of last radiographic visit prior to missed visits. Symptomatic/clinical disease progression without documented radiologic progression did not constitute progression.|Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 35 months)|A subset of the Intent-to-Treat (ITT) Population: all randomized participants with CR or PR. Censored participants: ramucirumab + docetaxel=80, placebo + docetaxel=28.|||months||95% Confidence Interval|Median
1224970|NCT00703326|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), based on the achievement of both measurement and confirmation criteria; by Investigator assessment. CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1224971|NCT00703326|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the first documented date of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who did not progress were censored at the last radiographic tumor assessment. If no post-baseline assessment was available censoring occurred at the date of randomization. If PD occurred after 2 or more missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=263, placebo + docetaxel=104.|||months||95% Confidence Interval|Median
1224972|NCT00703326|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death from any cause. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death or until data cutoff of 31-Mar-2013 (up to 49 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=448, placebo + docetaxel=225.|||months||95% Confidence Interval|Median
1224973|NCT00703326|Primary|Progression-Free Survival (PFS)|PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after ≥2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=231, placebo + docetaxel=94.|||months||95% Confidence Interval|Median
1224974|NCT00703261|Secondary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all statin-naive participants who completed the study and had complete image sets.|||Percent reduction||90% Confidence Interval|Geometric Mean
1224975|NCT00703261|Primary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all participants who completed the study and had complete image sets with usable data.|||Percent reduction||90% Confidence Interval|Geometric Mean
1224976|NCT00703157|Secondary|Left Atrial Dimension and Contractility||Through 24 months post-ablation|Data were not collected||||||
1224977|NCT00703157|Secondary|Reduced Anti-arrhythmic Drug Requirement||Through 24 months post-ablation|Data were not collected||||||
1224978|NCT00703157|Secondary|Assessment of AF Burden||Through 24 months post-ablation|Data were not collected||||||
1224979|NCT00703157|Secondary|Occurences of Treatment of Arrhythmic Episodes||Through 24 months post-ablation|Data were not collected||||||
1224980|NCT00703157|Secondary|Symptoms Associated With Atrial Arrhythmias||Through 24 months post-ablation|Data were not collected||||||
1224981|NCT00703157|Secondary|Reduced Number, Duration and Severity of AF Symptoms||Through 24 months post-ablation|Data were not collected||||||
1224982|NCT00703157|Secondary|Duration, Burden and Costs of Treatment Procedures||Through 24 months post- ablation|Data were not collected||||||
1224983|NCT00703157|Secondary|Mortality and Hospitalization||Time from procedure until 24 months post-ablation||||participants|||Number
1224984|NCT00703157|Secondary|Number of Subjects With Adverse Events, Associated With the Ablation Procedure||Time from procedure||||Participants|||Count of Participants
1224985|NCT00703157|Secondary|Treatment Failures Requiring Redo or Alternative Therapy||Time from procedure until 6 months post-ablation||||Participants|||Count of Participants
1224986|NCT00703157|Primary|Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.|AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.|Baseline through 3-6 months post-ablation||||percentage of time in AF||Standard Deviation|Mean
1224987|NCT00703118|Secondary|Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12|Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.|Week 4 and Week 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1224988|NCT00703118|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4||Baseline (Day 1) to Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||log10 IU/mL||Standard Deviation|Mean
1224989|NCT00703118|Secondary|Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)|Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).|Up to Week 72|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1224990|NCT00703118|Secondary|Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8|Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.|Week 4, Week 6, or Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1224991|NCT00703118|Secondary|Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned|SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).|Week 60|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1224992|NCT00703118|Secondary|Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)||Week 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1224993|NCT00703118|Secondary|Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4|RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1224994|NCT00703118|Primary|Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned|SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.|Week 72|Full Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Number
1224995|NCT00703092|Secondary|Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.||||||
1224996|NCT00703092|Primary|Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.||||||
1224997|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses|The kinetics of the antibody response to vaccination with A/Vietnam/04 is evaluated by the HAI GMT against the A/Vietnam/04 antigen at weekly intervals after receipt of 2 doses 7, 14 and 28 days apart|Weeks 1, 2, 3 and 4 after the second dose|Analyses are based on a modified intent to treat population. 5 subjects in the VN/VN, Day 0, 28 group not receiving vaccination 2 are excluded, as were 2, also in this group, due to receipt of prohibited vaccines.|||Titer||95% Confidence Interval|Geometric Mean
1224998|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1224999|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1225000|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. The CI shown as 5.0 to 5.0 reflect that all subjects had a titer of 5.0 for the VN,VN, Day 0,14 and VN, Day 0 groups.|Six months after last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1225001|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1225002|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1225003|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1225032|NCT00702949|Secondary|Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment||||percent change||95% Confidence Interval|Median
1225004|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1225005|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1225006|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1225007|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1225008|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1225009|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1225010|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1225011|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1225012|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1225769|NCT00697593|Primary|Hematology - Red Blood Cell Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^12/L||Standard Deviation|Mean
1225013|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after the second vaccination and review the Memory Aid with clinic staff at a follow up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after second vaccination|All subjects receiving the second vaccination are included in this outcome measure. The VN, Day 0 Group received only one dose.|||Participants|||Number
1225014|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after first vaccination|All subjects receiving the first vaccination are included in the safety population and analyses of safety are ITT. Three subjects were randomized but not vaccinated.|||Participants|||Number
1225015|NCT00703053|Secondary|Number of Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 180 days after the last vaccination.|Duration of study|All subjects receiving at least one study vaccination are included in the safety population and analyses of safety are intention to treat (ITT). Three subjects were randomized but not vaccinated.|||Events|||Number
1225016|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1225017|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Percentage of Participants|||Number
1225018|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Percentage of Participants|||Number
1225019|NCT00703014|Primary|Number of Infants in Current Follow Up Trial Experiencing SAEs|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.|||Participants|||Number
1225020|NCT00703014|Primary|Number of Infants Born in Current Follow Up Trial Experiencing AEs|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.|||Participants|||Number
1225021|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Participants|||Number
1225022|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Participants|||Number
1225023|NCT00702962|Secondary|To Assess the Safety Profile and Define the Toxicities of Using a Fixed Dose (300mg) of Vorinostat With Carboplatin and Etoposide|Evaluation of resultant adverse events that occurred with participants with extensive disease SCLC after initiating treatment using a fixed dose of vorinostat in combination with carboplatin and etoposide.|2 years, not analyzed|One participant enrolled in the Phase II portion and discontinued treatment prematurely due to concurrent health issues and hospitalization. No unanticipated adverse events occurred while on study. The study closed prematurely due to low accrual. No analysis conducted.||||||
1225024|NCT00702962|Secondary|Evaluate Objective Response Rate Among Patients With Extensive Disease SCLC Receiving Carboplatin and Etoposide With a Fixed Dose of Vorinostat.|Eligibility limits the study population to those who have measurable disease pre-treatment. This secondary outcome measure was intended to objectively evaluate disease response and survival rate in recipients of the investigational medication regimen. Disease response was performed using standard diagnostic imaging. Tumor markers and cytology may be used to support the imaging results. Objective response rate was defined as progression-free survival (PFS) among treatment recipients. PFS, is defined as time (in months) from entry to clinical evidence of disease progression or death without progression. The clinical trial closed prematurely due to low accrual. For this reason, an analysis of this secondary objective would not be meaningful. No analysis done.|2 years, not analyzed|One participant enrolled and treated in the Phase II portion. Participant rendered off treatment and off study prior to completion due to concurrent health disorders. The clinical trial closed prematurely due to low accrual. For this reason, an analysis of this secondary objective would not be meaningful. No analysis done.||||||
1225025|NCT00702962|Secondary|To Evaluate Overall Survival of Patients With Extensive Disease SCLC Receiving Carboplatin, Etoposide, and a Fixed Dose (300mg) of Vorinostat|For the purpose of this study, overall survival is defined as the percentage of participants who are alive at two years post initiation of study treatment.|2 years, not analyzed|One participant enrolled on Phase II. Off treatment and off study prematurely due to concurrent health disorders.||||||
1225026|NCT00702962|Primary|Assess Maximum Tolerated Dose of Vorinostat When Combined With Carboplatin and Etoposide of Patients With Extensive Disease SCLC|"To estimate the maximum tolerated dose of vorinostat using a traditional dose escalation schedule (3 + 3 design). MTD is determined by assessing for specific predefined dose limiting toxicities. A starting dose of vorinostat 200mg was combined with carboplatin and etoposide. Dose escalation went in increments of 100mg (i.e. 300mg, 400mg)."|2 years, not analyzed|The first three participants enrolled were treated at dose level 1 (vorinostat 200 mg). Phase I protocol closed prematurely with no additional subjects enrolled. No analysis due to premature closure.||||||
1225027|NCT00702949|Secondary|Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment|Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better.|Baseline, after week 6 of treatment.||||units on a scale||Full Range|Median
1225028|NCT00702949|Primary|Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||percent change||95% Confidence Interval|Median
1225029|NCT00702949|Secondary|Toxicity Data for the Individual Study Arms From the Symptom Experience Diary .|A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions).|Baseline, 6 weeks during treatment.||||units on a scale||Full Range|Median
1225030|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||percent change||95% Confidence Interval|Median
1225031|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||units on a scale||95% Confidence Interval|Median
1225062|NCT00702780|Primary|% Change of Whole Brain Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.|||percentage of change||Standard Deviation|Mean
1225033|NCT00702949|Secondary|Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment||||Hot flashes per day||95% Confidence Interval|Median
1225034|NCT00702949|Primary|Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||units on a scale||95% Confidence Interval|Median
1225035|NCT00702923|Secondary|Number of Participants With PSA Recurrence.|PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.|one year||||participants|||Number
1225036|NCT00702923|Secondary|The Number of Participants With an Increase in PSA Doubling Time||Up to 18 months after last dose of study agent||||participants|||Number
1225037|NCT00702923|Primary|The Number of Participants Who Developed Cancer Antigen-specific Immune Responses||Up to 12 months after treatment with study agent||||participants|||Number
1225038|NCT00702884|Secondary|Quantitative Assessment of Proliferating Tumor Cells and Apoptosis|Biopsy sample taken from patients before and after treatment Apoptosis measures using the terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) assay, which measures 3’ nicked DNA. DNA is degraded in the early steps of apoptosis into low molecular weight (LMW) fragments and the production of single strand breaks in the high molecular weight DNA.Both of these features of apoptosis can be detected by labeling free 3’-OH termini with modified nucleotides, in our case this will be biotin-labeled dUTP. Terminal deoxynucleotidyl transferase (TdT) is an enzyme that labels blunt-ends of DNA breaks and can catalyze polymerization of nucleotides to free 3’-OH DNA ends in a template-independent manner. The newly incorporated nucleotides are detected by a secondary antibody, avidin-peroxidase. After substrate reaction, the stained cells can be detected and counted under a light microscope. Apoptotic cells will be fixed with formaldehyde which links LMW DNA|up to 4 years|Analysis for tumor cells not performed due to insufficient samples available||||||
1225039|NCT00702884|Secondary|Change in Mean Vessel Density|Quantitative assessment of proliferating tumor cells, and apoptosis, of the laboratory and radiographic correlates, the analyses will be purely explorative.|up to 4 years|Insufficient tissue was available and the analysis for mean vessel density not performed||||||
1225040|NCT00702884|Secondary|Frequency and Severity of Adverse Events|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.|up to 4 years||||percentage of patients|||Number
1225041|NCT00702884|Secondary|Median Progression-free Survival Time|Progression free survival was measured as the time from start of treatment to the first measurement of tumor growth.|up to 4 years||||weeks||95% Confidence Interval|Median
1225042|NCT00702884|Secondary|Median Overall Survival Time|The median overall survival time will be reported using the 95% confidence intervals for the parameters.|up to 4 years||||weeks||95% Confidence Interval|Median
1225043|NCT00702884|Secondary|Overall Response Rate|The Overall Response Rate (ORR) was assessed using Partial Response + Complete Response for patients. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|up to 4 years|Durable Complete Response= PR + SD > 10 weeks|||patients|||Number
1225044|NCT00702884|Primary|Progression-free Survival Rate|Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks|up to 24 weeks||||weeks||95% Confidence Interval|Median
1225045|NCT00702845|Secondary|Number of Participants With Pregnancies|A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.|Up to 10 weeks after ET (up to a maximum of 14 weeks)|ITT Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.|||Participants|||Number
1225046|NCT00702845|Secondary|Number of Participants With Miscarriages|"A miscarriage, also known as a spontaneous abortion, was defined as the loss of a fetus without induction or instrumentation."|Up to 10 weeks after ET (up to a maximum of 14 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who had a biological pregnancy.|||Participants|||Number
1225047|NCT00702845|Secondary|Implantation Rate for Participants With ET|The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.|Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ET.|||Percentage||Standard Deviation|Mean
1225063|NCT00702780|Primary|% Change of Hippocampus Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.|||percentage of change||Standard Deviation|Mean
1225048|NCT00702845|Secondary|Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)|"Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. Other grade embryos were those that did not qualify as Grade 1, 2, or 3."|Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent IVF and/or ICSI.|||Number of embryos||Standard Deviation|Mean
1225049|NCT00702845|Secondary|Fertilization Rate|Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.|Up to 10 weeks after ET|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received fertilized oocytes.|||Percentage||Standard Deviation|Mean
1225050|NCT00702845|Secondary|Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)|The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).|Up to 36 hours after administration of hCG|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ICSI.|||Number of oocytes||Standard Deviation|Mean
1225051|NCT00702845|Secondary|Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration|For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.|Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Follicles||Standard Deviation|Mean
1225052|NCT00702845|Secondary|Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||pg/mL||Full Range|Median
1225053|NCT00702845|Secondary|Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||nmol/L||Full Range|Median
1225054|NCT00702845|Secondary|Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||pmol/L||Full Range|Median
1225055|NCT00702845|Secondary|Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||IU/L||Full Range|Median
1225056|NCT00702845|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||IU/L||Full Range|Median
1225057|NCT00702845|Secondary|Total Duration of Stimulation (Days)|Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Days||Full Range|Median
1225058|NCT00702845|Secondary|Number of Days Treated With recFSH|Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Days||Full Range|Median
1225059|NCT00702845|Secondary|Total Dose of recFSH Administered From Day 8 Onwards|Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||International Unit (IU)||Full Range|Median
1225060|NCT00702845|Secondary|Total Dose of recFSH Administered|Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||International Unit (IU)||Full Range|Median
1225061|NCT00702845|Primary|Number of Cumulus-oocyte-complexes Retrieved, Per Attempt|The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.|One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)|Intent-to-Treat (ITT) Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.|||Number of cumulus-oocyte-complexes||Standard Deviation|Mean
1225064|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 8 (84 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1225065|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 7 (72 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1225066|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 6 (60 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1225067|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 5 (48 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1225068|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 4 (36 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1225069|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 3 (24 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1225070|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 2 (12 wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1225071|NCT00702754|Primary|Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms|7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms|Session 1 - Time 0, 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Error|Mean
1225072|NCT00702715|Secondary|Time to Recovery of T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
1225073|NCT00702715|Secondary|Time to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
1225074|NCT00702715|Primary|Time to Recovery of the T4/T1 Ratio to 0.9.|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
1225075|NCT00702702|Primary|Change in Hemoglobin vs Placebo|Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3|3 months|Study prematurely terminated for safety reasons||||||
1225076|NCT00702689|Secondary|Change in Immunosuppression|Change in immunosuppression was defined by an increase or decrease in steroid use form baseline.|6 months|Pred:prednisone; tacro:tacrolimus; MPred:methylprednisolone; siro:sirolimus; and MMF:mycophenolate mofetil|||participants|||Number
1225077|NCT00702689|Secondary|Lung Function Score at Baseline and 6 Months|Lung function was graded by the National Institutes of Health Chronic Graft Versus Host Disease organ response criteria. The Lung function score = forced expiratory volume 1 (FEV1) score + carbon monoxide diffusing capacity (DLCO) score, with a possible range of 2 (better outcome)-12 (worst outcome). The percent predicted FEV1 and DLCO (adjusted for hematocrit but not alveolar volume) should be converted to a numeric score as follows: >80% =1; 70-79% = 2; 60-69% = 3; 50-59% = 4; 40-49% = 5; <40% = 6.|Baseline and 6 Months||||units on a scale|||Number
1225770|NCT00697593|Primary|Hematology - Hemoglobin|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||g/L||Standard Deviation|Mean
1225078|NCT00702689|Secondary|Total Chronic Graft Versus Host Disease (cGVHD) Provider Global Rating Score at Baseline and 6 Months|The provider global rating is a physician impression of severity of cGVHD symptoms from a scale of zero (no symptoms) to 10 (most severe GVHD symptoms possible).|Baseline and 6 months||||Provider Global Rating Score|||Number
1225079|NCT00702689|Secondary|Total Skin Score at Baseline and 6 Months|Total skin score was graded by the National Institutes of Health Consensus Criteria. Skin score was calculated by dividing the total score by seven domains (skin, eye, oral, joint, gastrointestinal, hepatic, pulmonary) in men and 8 domains in women (previous domains noted plus gynecologic). Total skin score is a percentage of body surface area (BSA) involvement (range 0-100%). It was calculated from the sum of moveable body surface BSA and non-moveable BSA. Higher numbers = greater body surface area affected.|Baseline and 6 Months||||units on a scale|||Number
1225080|NCT00702689|Secondary|Average Percentage Change in Range of Motion (ROM) Deficit|One or more joints were assessed for ROM deficit by a physiatrist with expertise in graft versus host disease and joint ROM.|6 months|This outcome is the average percentage change in ROM deficit among 13 evaluable patients based on each patients baseline range of motion deficit compared to his/her ROM deficit at 6 months.|||Percent change||Inter-Quartile Range|Mean
1225081|NCT00702689|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|41 months, 27 days||||Participants|||Number
1225082|NCT00702689|Primary|Primary Range of Motion (ROM) Response|Progressive disease is defined as joint ROM: decrease of >25% in composite ROM score on 2 consecutive evaluations at least 2 weeks apart, but not greater than 4 weeks apart or steroid pulse: >1 steroid pulse per 3 month period if administered for sclerotic-type chronic graft versus host disease (ScGVHD). Response is joint ROM: increase of >25% in composite ROM score. Maximal response is a response with no further improvement over 2 sequential 3-month evaluations. Stable disease does not meet the criteria for progression, response, or maximal response.|6 months||||participants|||Number
1225083|NCT00702689|Primary|Percent Change in Absolute Range of Motion (ROM) From Baseline to 6 Months|A change in ROM is 25% or greater from baseline. A partial response required improvement in 25% or more in ROM. Progression required 25% or greater loss of ROM.Patients with negative values in the Table are those who lost ROM. Percent improvement in ROM for 1-3 target joints. For patients with >1 target joint, the average ROM improvement was calculated. The average percentage change in ROM deficit from baseline to 6 months was obtained based on the number of degrees of ROM change (6 months)/total ROM deficit (baseline) at each joint.|6 months||||Percent change from baseline|||Number
1225084|NCT00702650|Secondary|Change From Baseline to Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.|||units on a scale||Standard Deviation|Mean
1225085|NCT00702650|Secondary|Change From Baseline to Endpoint in Haematocrit|Haematocrit: percentage of total blood volume made up of blood cells|Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||percentage of red blood cells||Standard Deviation|Mean
1225086|NCT00702650|Secondary|Change From Baseline to Endpoint in Haemoglobin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||g/dL||Standard Deviation|Mean
1225087|NCT00702650|Secondary|Change From Baseline to Endpoint in Estradiol||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||pg/mL||Standard Deviation|Mean
1225088|NCT00702650|Secondary|Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||mIU/mL||Standard Deviation|Mean
1225089|NCT00702650|Secondary|Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)||Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.|||ng/mL||Standard Deviation|Mean
1225090|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Glucose||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||mg/dL||Standard Deviation|Mean
1225091|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Insulin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||uIU/mL||Standard Deviation|Mean
1225092|NCT00702650|Secondary|Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||units on a scale||Standard Deviation|Mean
1225093|NCT00702650|Secondary|Change From Baseline to Endpoint in Psychosexual Daily Questionnaire|Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||units on a scale||Standard Deviation|Mean
1225094|NCT00702650|Secondary|Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL|Cmin is the minimum observed serum concentration (<300 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
1225095|NCT00702650|Secondary|Percentage of Participants With Cmax >2500 ng/dL|Cmax is the maximum observed serum concentration (>2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
1225096|NCT00702650|Secondary|Percentage of Participants With Cmax Between 1800 and 2500 ng/dL|Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
1225097|NCT00702650|Secondary|Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL|Cmax is the maximum observed serum concentration (>1500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
1225098|NCT00702650|Primary|Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120|Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. Participants were also included if they withdrew prior to Day 120 because of adverse event or lack of efficacy (considered as treatment failures).|||percentage of participants||95% Confidence Interval|Number
1225099|NCT00702624|Primary|Number of Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Live born infants|||Number
1225100|NCT00702624|Primary|Number of Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Live born infants|||Number
1225101|NCT00702624|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Participants|||Number
1225102|NCT00702624|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Participants|||Number
1225103|NCT00702624|Primary|Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.|||Percentage of participants|||Number
1225104|NCT00702546|Secondary|Percentage of Participants With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
1225105|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
1225106|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
1225107|NCT00702546|Secondary|Percentage of Participants in Follow up Study With an Ecotopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
1225108|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711 with vital pregnancy|||Percentage of participants|||Number
1225109|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants in follow up study P05711 with a clinical pregnancy|||Percentage of participants|||Number
1225110|NCT00702546|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.|Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.|||Percentage of participants|||Number
1225111|NCT00702520|Primary|Take-Home Baby Rate|The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).|Birth of a one or more live babies (Up to 1 year)|Participants treated with Corifollitropin alpha in the base study (P05788, 38833).|||Percentage of participants|||Number
1225112|NCT00702520|Primary|Number of Infants Experiencing SAEs|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
1225113|NCT00702520|Primary|Number of Infants Experiencing AEs|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
1225114|NCT00702520|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
1225115|NCT00702520|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
1225116|NCT00702507|Secondary|Number of Participants With Mycological Cure of First to Third Recurrent Episodes|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
1225117|NCT00702507|Secondary|Number of Participants With Clinical Cure of First to Third Recurrent Episodes|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clinical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
1225273|NCT00701363|Secondary|Serum Growth Hormone (GH) Levels||At Baseline, week 24 and week 48|"ITT population. n = Number of subjects at the visit.~Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2."|||ng/mL||Standard Deviation|Mean
1225118|NCT00702507|Secondary|Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as Successes; those without OC were categorized as Failures (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication."|Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
1225119|NCT00702507|Secondary|Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.|||scores on a scale||Full Range|Median
1225120|NCT00702507|Secondary|Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.|||scores on a scale||Full Range|Median
1225121|NCT00702507|Secondary|Number of Participants With Mycological Cure|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population|||participants|||Number
1225122|NCT00702507|Secondary|Number of Participants With Clinical Cure|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clianical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population|||participants|||Number
1225123|NCT00702507|Primary|Number of Participants With Overall Cure (OC)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide [KOH] and culture results). Participants who had OC were categorized as Successes; those without OC were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|Modified Intent-to-Treat (MITT) Population: all participants who were dispensed study drug and had demonstrated clinical symptoms of diaper dermatitis (DD) (DD severity index score of 4-8; clinical erythema grade of >=2 [see outcome measure #4 for a description]) and confirmed Candida species (positive baseline KOH and culture for Candida species)|||participants|||Number
1225124|NCT00702468|Secondary|Carer Global Impressions of Change for Ease of Transfer|"The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):~How has the subject’s general functional abilities changed?”~How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35||||paticipants|||Number
1225125|NCT00702468|Secondary|Carer Global Impressions of Change for Functional Ability|"The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):~How has the subject’s general functional abilities changed?”~How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35||||paticipants|||Number
1225126|NCT00702468|Secondary|Subject Global Impressions of Change.|"At baseline subjects will write a brief description of their spasticity caused by MS and how it affects them emotionally, physically and their ability to function with day to day activities. This will be used to aid their memory before they answer the following question which is rated on a seven-point scale.~“Please assess the change in your spasticity due to MS since immediately before receiving the first course of study treatment (Baseline) using the scale below” The markers are: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better."|Day 35||||participants|||Number
1225127|NCT00702468|Secondary|Daily Sleep Disruption NRS|Subjects will be asked: ”On a scale of 0-10 please indicate how your spasticity disrupted your sleep last night” with the anchors 0 = ‘did not disrupt sleep’, 10 = ‘completely disrupted (unable to sleep at all)’.|Week 1- Week 5|It is important to note that 16 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.|||points on scale||Standard Deviation|Mean
1225577|NCT00699660|Secondary|PTSD Diagnosis|Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).|Post-exam, same day||||participants|||Number
1225128|NCT00702468|Secondary|Timed 10-metre Walk.|The time taken to travel 10 metres.|Week 2 and Week 5|ITT. Only 4 placebo subjects were included in the analysis and 11 of the Sativex subjects. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||Seconds||Standard Deviation|Mean
1225129|NCT00702468|Secondary|Change in Motricity Index|The Motricity Index involves assessing three movements in both the arms and the legs. In the arm the three movements are; pinch grip, elbow flexion and shoulder abduction and the three leg movements are, ankle dorsiflexion, knee extension and hip flexion. The total arm/leg score is then the addition of the score for the three arm/leg movements. One point is then added to each limb score so that the maximum score is 100 points. The higher the score the better the limb movement.|Week 2 and Week 5|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||points on scale||Standard Deviation|Mean
1225130|NCT00702468|Secondary|Change in Modified Ashworth Scale.|"The Modified Ashworth Scale was completed at baseline and at the end of treatment at approximately the same time of day. All 20 muscle groups were assessed for spasticity (using a 0=no increase in muscle tone to 4 scale=affected part rigid in flexion or extensions), to result in a total score out of 80. The higher the score the worse the spasticity is.~The change from baseline to end of study was assessed. The higher the score the better"|Day 7 to Day 28|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||score on scale||Standard Deviation|Mean
1225131|NCT00702468|Secondary|Change in Mean Daily Spasticity Severity as Measured on a Spasticity Severity 0-10 Numerical Rating Scale (NRS).|"Spasticity NRS was completed daily by answering the following question:~“On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’. The change in mean spasticity severity NRS from baseline to end of study (last seven days)was calculated. A negative change from baseline indicates an improvement in spasticity."|Baseline (Week 1) to Week 5|It is important to note that 17 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.|||points on scale||Standard Deviation|Mean
1225132|NCT00702468|Primary|Number of Subjects Who Experience Treatment Failure.|The time to treatment failure was calculated as the number of days from the first day of treatment up to the day of treatment failure. The day of treatment failure was the earliest of:the day of premature cessation of study medication;the first day of the longest period, ending on the last day of treatment, where the mean spasticity NRS had increased by at least 20% and at least 1 unit from the treatment baseline; the day of a clinically relevant increase in anti-spasticity or disease modifying medication. The number of subjects who failed treatment were calculated.|Week 1- Week 5||||Participants|||Number
1225133|NCT00702403|Secondary|Relapse|The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia|1 and 3 years|Proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia among those who did not die from non-relapse causes during the first year, and first 3-years after transplant.|||Participants|||Count of Participants
1225134|NCT00702403|Secondary|Patients Alive With Out Relapse|The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year|Up to 1 year|Proportion alive without relapse among the total number of patients with minimal residual disease follow-up data|||Participants|||Count of Participants
1225135|NCT00702403|Secondary|Survival|The proportion of study participants alive at 1, 2 and 3 years|Up to 3 years|Overall Survival (complete follow-up is available out to three years for all patients)|||Participants|||Count of Participants
1225136|NCT00702403|Secondary|The Proportion of Patients at 1 Year With Treatment Efficacy Success|To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, >5% BCR/ABL in marrow by fluorescent in situ hybridization, or >1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).|Up to 1 year|"The analysis population was considered in two ways: first the number of treatment success in the entire cohort (by intention to treat), and second the number of treatment successes among only those patients who did not die before 1 year from non-relapse mortality."|||Participants|||Count of Participants
1225137|NCT00702403|Primary|Number of Participants With Treatment Safety Failure|Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.|Up to 365 days post-transplant|"Critical to note are two intention-to-treat populations: the 1st (N=57) at time of consent, evolved into the second ITT population (N=40), because 17 subjects lost eligibility to begin relapse prophylaxis at engraftment. A 2nd wave of discontinuations occurred at or after Day 81 when all patients were to be switched from imatinib to nilotinib."|||Participants|||Count of Participants
1225138|NCT00702377|Primary|Corneal Staining|Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye’s surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42||||Units on a scale||Standard Deviation|Mean
1225219|NCT00701805|Secondary|The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%||Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||Percentage of Participants|||Number
1225139|NCT00702377|Primary|Conjunctival Staining|Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye’s surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42||||Units on a scale||Standard Deviation|Mean
1225140|NCT00702377|Primary|Tear Break-up Time|Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.|Day 0, Day 7, Day 14, Day 28, and Day 42||||seconds||Standard Deviation|Mean
1225141|NCT00702364|Secondary|Neurobehavioral Functioning Inventory Depression Subscale|"Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring never, rarely, sometimes, often, or always. Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology."|Post treatment||||T-score||95% Confidence Interval|Mean
1225142|NCT00702364|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score|The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms (“never”, “rarely”, “sometimes”, “often”, and “very often”). A previous study of the ASRS found the self-report to be both valid (Cronbach’s alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score.|Post treatment||||units on a scale||95% Confidence Interval|Mean
1225143|NCT00702364|Primary|Stroop Test Interference T-score|The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm.|Post treatment||||T-score||95% Confidence Interval|Mean
1225144|NCT00702364|Primary|CDR Power of Attention|"Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [19] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations.~Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally,"|Post treatment||||msec||95% Confidence Interval|Mean
1225145|NCT00702338|Primary|Number of Infants With SAEs During Follow-up|An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.|||participants|||Number
1225146|NCT00702338|Primary|Number of Infants With AEs During Follow-up|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.|||participant|||Number
1225147|NCT00702338|Primary|Number of Mothers With Serious AEs (SAEs) During Follow-up|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.|||participants|||Number
1225160|NCT00702325|Secondary|Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period|Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
1225237|NCT00701727|Secondary|de Novo Cholesterol Synthesis (DNC)|Plasma DNC will be measured following the isotope infusion of deuterated water, expressed as %.|7 weeks|per protocol, all subjects|||%/day plasma DNC||Standard Deviation|Mean
1225148|NCT00702338|Primary|Number of Mothers With Adverse Events (AEs) During Follow-up|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.|||participants|||Number
1225149|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis|Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Participants in the Intent-to-Treat group (ITT) in base study P05693 (NCT00697255) that received bolus injection of hCG.|||percentage of participants|||Number
1225150|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Intent-to-Treat group (ITT) consisted of all treated participants in base study P05693 (NCT00697255): 5 participants in Stage Ia and 3 participants in Stage Ib.|||percentage of participants|||Number
1225151|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|1 week||||Participants|||Number
1225152|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away|1 week||||Participants|||Number
1225153|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|12 week||||Participants|||Number
1225154|NCT00702325|Secondary|Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)|There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
1225155|NCT00702325|Secondary|Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment|There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.|12 weeks||||Proportion of Participants|||Number
1225156|NCT00702325|Secondary|Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])|Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1225157|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away|12 week||||Participants|||Number
1225158|NCT00702325|Secondary|Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period|Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
1225159|NCT00702325|Secondary|Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period|Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
1225161|NCT00702325|Secondary|Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period|Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
1225162|NCT00702325|Secondary|Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
1225163|NCT00702325|Secondary|Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
1225164|NCT00702325|Secondary|Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period|Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Number of nights||Standard Deviation|Mean
1225165|NCT00702325|Secondary|Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1225166|NCT00702325|Secondary|Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1225167|NCT00702325|Secondary|Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1225168|NCT00702325|Secondary|Number of Withdrawals Due to a Predefined Asthma Event|Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)|12 weeks||||Participants|||Number
1225169|NCT00702325|Secondary|Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry|Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)|12 weeks||||Participants|||Number
1225170|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period|Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/second||Standard Deviation|Mean
1225171|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1225172|NCT00702325|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
1225238|NCT00701727|Secondary|Change From Baseline in Total Cholesterol, From Fasting Plasma Samples|plasma levels of total cholesterol|7 weeks|per protocol, all subjects|||mg/dL total cholesterol||Standard Deviation|Mean
1225173|NCT00702325|Secondary|Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
1225174|NCT00702325|Primary|Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1225175|NCT00702299|Secondary|Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed|Cmax levels were found through plasma collected between 0.5 to 4 hours and at 24 hours after initiation of intraperitoneal administration|18 months||||ug/mL||Standard Deviation|Mean
1225176|NCT00702299|Secondary|Overall Survival||Average Length of follow-up 788 days||||Days||Full Range|Median
1225177|NCT00702299|Secondary|Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125|Progression was evaluated with posttreatment CT scans and measured changes in cancer antigen 125 levels 6 months after the initiation of the treatment regimen, or within one month after discontinuation of treatment if stopped early. Cancer antigen 125 response in evaluable patients (N=13) was analyzed using the modified Gynecologic Cancer Intergroup (GCIG) criteria. There was one evaluable patient by Response Evaluation Criteria in Solid Tumors(RECIST) criteria|18 months||||% of participants|||Number
1225178|NCT00702299|Primary|Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)|Toxicity was assessed by NCI Common Toxicity Criteria for Adverse Effects v3.0|18 months||||participants|||Number
1225179|NCT00702299|Primary|Patients That Completed at Least 6 Courses of Therapy of Pemetrexed Along With Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)at the Determined Maximum Tolerated Dose|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the Maximum Tolerance Dose (MTD) would be determined to be the next lower dose level.|18 months||||% of participants|||Number
1225180|NCT00702299|Primary|Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the maximum tolerated dose would be determined to be the next lower dose level.|18 months||||mg/m2|||Number
1225181|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
1225182|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
1225183|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
1225184|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ectopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study.|||Percentage of participants|||Number
1225185|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a vital pregnancy.|||Percentage of participants|||Number
1225186|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a clinical pregnancy.|||Percentage of participants|||Number
1225187|NCT00702273|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.|Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial|ITT group from base trial P05787, consisting of randomized participants who were treated with Corifollitropin Alfa or recFSH.|||Percentage of participants|||Number
1225188|NCT00702234|Primary|Number of Live Born Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
1225189|NCT00702234|Primary|Number of Live Born Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
1225190|NCT00702234|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
1225191|NCT00702234|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
1225192|NCT00702234|Primary|Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)|The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.|Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)|Participants administered corifollitropin alfa in base study P05714 (NCT00696878)|||percentage of participants|||Number
1225193|NCT00702221|Primary|Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)||baseline to 8 weeks|study prematurely terminated|||mmHg||Standard Error|Mean
1225194|NCT00702208|Primary|Kappa Coefficient|Kappa comparing clinician-collected cytology result to self-lavage cytology result|1-3 months between 2 specimen collections||||kappa coefficient for paired specimens||95% Confidence Interval|Number
1225195|NCT00702208|Secondary|Outcome: Acceptability of Device|On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening|cross-sectional - asked at time of Screener use|For acceptability, 197 women used the device; 30 of these women did not have valid gold standard results but did respond to acceptability, thus for acceptability endpoint the sample size is 197 (while the sample size is 167 for sensitivity, specificity and kappa analyses due to insufficient sepcimens /loss to follow-up for colposcopy).|||units on a scale||Inter-Quartile Range|Median
1225196|NCT00702208|Primary|Sensitivity and Specificity|"We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results.~The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints."|1-3 months between 2 specimen collections||||% of participants correctly diagnosed||95% Confidence Interval|Number
1225197|NCT00702143|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||SUVR||Standard Deviation|Mean
1225198|NCT00702143|Secondary|Proportion of Positive Florbetapir-PET Scans|Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||percentage of amyoid positive scans|||Number
1225199|NCT00702143|Primary|Qualitative Amyloid Image Assessment|Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||participants|||Number
1225217|NCT00701805|Secondary|Duration of 2 Consecutive Decreases in iPTH >= 50%||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||days||Standard Deviation|Mean
1225200|NCT00701935|Secondary|Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event|All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||hypoglycemia rate/year||Standard Error|Mean
1225201|NCT00701935|Secondary|Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months|Change in HDL cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
1225202|NCT00701935|Secondary|Change in Triglycerides From Baseline to 6 Months|Change in triglycerides|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
1225203|NCT00701935|Secondary|Change in Total Cholesterol From Baseline to 6 Months|Change in total cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
1225204|NCT00701935|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months|Change in Diastolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1225205|NCT00701935|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months|Change in Systolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1225206|NCT00701935|Secondary|Change in Weight From Baseline to 6 Months|Change in weight|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analyzed.|||kg||Standard Error|Least Squares Mean
1225207|NCT00701935|Secondary|Change in Fasting Plasma Glucose From Baseline to 6 Months|Change in Fasting plasma glucose|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Analysis done only for patients with measurement at Month 6.|||mmol/L||Standard Error|Least Squares Mean
1225208|NCT00701935|Secondary|Percentage of Patients With HbA1c <=7.0% at 6 Months|Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received.Analysis done only for patients with measurement at Month 6.|||Percentage of patients|||Number
1225209|NCT00701935|Secondary|Change in HbA1c From Baseline to 6 Months|Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analysed.|||% change||Standard Error|Least Squares Mean
1225210|NCT00701935|Secondary|Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months|Percentage change in subcutaneous abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
1225211|NCT00701935|Secondary|Percentage Change in Total Abdominal Fat From Baseline to 6 Months|Percentage change in total abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
1225212|NCT00701935|Primary|Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months|Percentage change in abdominal visceral fat|baseline, 6 months|Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
1225213|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.|||Percentage of participants|||Number
1225214|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.|||Percentage of participants|||Number
1225215|NCT00701805|Other Pre-specified|The Percentage of Participants With Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)|Anytime from Week 13 through Week 53||||Percentage of participants|||Number
1225216|NCT00701805|Secondary|Duration of 2 Consecutive iPTH Values <= 180 pg/mL||From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||days||Standard Deviation|Mean
1225220|NCT00701805|Secondary|The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||Percentage of participants|||Number
1225221|NCT00701805|Secondary|The Mean Change in Intact Parathyroid Hormone (iPTH)||From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||picograms/milliliter (pg/mL)||95% Confidence Interval|Mean
1225222|NCT00701805|Primary|The Percentage of Participants With Hyperphosphatemia|The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.|||Percentage of participants|||Number
1225223|NCT00701805|Primary|The Percentage of Participants With of Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.|||Percentage of participants|||Number
1225224|NCT00701779|Secondary|Number of Participants With a Reduction of AUR and BPH-related Surgery|To assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior improvement in the clinical outcomes of AUR or BPH-related prostatic surgery to BPH patients.|13 months||||Participants|||Count of Participants
1225225|NCT00701779|Secondary|Economic Impact|Annual financial cost per participant starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin.|13 months||||US dollars||Standard Deviation|Mean
1225226|NCT00701779|Secondary|Safety and Tolerability|To assess safety and tolerability of starting with combination therapy with Dutasteride and Tamsulosin and subsequent elimination of Tamsulosin. Evaluating number of reported adverse events designated as possibly or probably study-drug related.|13 months||||adverse events|||Number
1225227|NCT00701779|Secondary|Health Outcome Measures|Number of participants who are able to subsequently reduce or discontinue Tamsulosin usage after starting with combination therapy with Dutasteride and Tamsulosin while still maintaining the same degree of improvement in lower urinary tract symptoms|13 months||||Participants|||Count of Participants
1225228|NCT00701779|Primary|Prostate Specific Antigen|Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||ng/mL||Standard Deviation|Mean
1225229|NCT00701779|Primary|Post-void Residual Volume|Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||mL||Standard Deviation|Mean
1225230|NCT00701779|Primary|Benign Prostate Hyperplasia Impact Index|"Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Benign Prostatic Hyperplasia Impact Index asked the following:~Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)~Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)~Overall, how bothersome has any trouble with urination been during the past month? (0-3)~Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13."|12 months||||units on a scale||Standard Deviation|Mean
1225231|NCT00701779|Primary|Peak Flow Rate (QMax)|Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||ml/sec||Standard Deviation|Mean
1225232|NCT00701779|Primary|International Prostate Symptom Score|"Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom.~Total range is from 0-35. The scores are evaluated as such:~0-7: Mild 8-19: Moderate 20-35: Severe"|12 months||||units on a scale||Standard Deviation|Mean
1225233|NCT00701727|Secondary|High-density Lipoprotein (HDL)|Change from baseline in plasma HDL, measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL HDL||Standard Deviation|Mean
1225234|NCT00701727|Secondary|Low-density Lipoprotein (LDL);|Change from baseline in plasma low-density lipoprotein(LDL), measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL LDL||Standard Deviation|Mean
1225235|NCT00701727|Secondary|Triglycerides (TG)|Change from baseline in plasma triglycerides, measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL TG||Standard Deviation|Mean
1225236|NCT00701727|Secondary|Cholesterol Efflux Rate (Ra Cholesterol)|The efflux, or mobilization, rate of cholesterol from peripheral tissues into the plasma will be measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® and 10 % ethanol is given piggy-backed into normal saline over 20 hours (4pm – 12 noon). This is used to determine rate of appearance (Ra) cholesterol, which will be measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol that will be traced into biliary sterols.|7 weeks|per protocol, all subjects|||mg/kg/hr cholesterol||Standard Deviation|Mean
1225239|NCT00701727|Primary|Fecal Excretion of Plasma-derived Cholesterol|"(Fecal excretion of plasma-derived cholesterol):The following measurements will be made following isotope infusion:~The composition of fecal neutral and acidic sterols will be measured as % of total.~The excretion rate of fecal neutral and acidic sterols will be measured as mg/day.~The isotopic enrichment of both fecal neutral and acidic sterols will be measured as atomic percent excess (% APE).~Fecal isotope excretion, or recovery, of plasma-derived cholesterol will be calculated as %/day."|7 weeks|Per Protocol,all subjects|||mg/day cholesterol excreted||Standard Deviation|Mean
1225240|NCT00701714|Secondary|Immunogenicity|Number of participants with antibody formation against Epoetin during treatment period (safety set)|13 weeks||||participants|||Number
1225241|NCT00701714|Primary|Weekly Epoetin Dose|Mean weekly epoetin dose [IU/kg] in study weeks 11-13|weeks 11-13|Full analysis set required: “all randomized patients who received at least one dose of the study medication and for whom at least one Hb value after study day 27 was available”. 3 out of 174 patients started in EPO HEXAL group and 6 out of 163 patients started in ERYPO group had no Hb values after study day 27 so they were excluded from analysis.|||IU/kg||Standard Deviation|Mean
1225242|NCT00701714|Primary|Change in Hemoglobin Level|Mean absolute change in hemoglobin (baseline to end of study week 13)|13 weeks|Full analysis set required: “all randomized patients who received at least one dose of the study medication and for whom at least one Hb value after study day 27 was available”. 3 out of 174 patients started in EPO HEXAL group and 6 out of 163 patients started in ERYPO group had no Hb values after study day 27 so they were excluded from analysis.|||g/dL||Standard Deviation|Mean
1225243|NCT00701675|Primary|Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg|Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of <17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe.|11 weeks from baseline|sertraline 50mg group and placebo group each had 2 subjects with missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
1225244|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Baseline to Week 25|The SDS comprised all treated patients.|||participants|||Number
1225245|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters.|Baseline to Week 25|The SDS comprised all treated patients.|||participants|||Number
1225246|NCT00701662|Secondary|Number of Patients With Local/Injection Site Reactions|All AEs arising from local/injection site reactions.|For the duration of the study, up to Week 25|The SDS comprised all treated patients.|||participants|||Number
1225247|NCT00701662|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered. Included all AEs that occurred during the entire study period.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The SDS comprised all treated patients.|||AEs per infusion|Participants||Number
1225248|NCT00701662|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Included all AEs that occurred during the entire study period.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The safety data set (SDS) comprised all treated patients.|||participants|||Number
1225249|NCT00701662|Secondary|Overall Health Status at Baseline and Week 25|Overall Health Status was assessed using a Visual Analogue Scale (VAS). Patients were asked to rate their overall health status by placing a mark on a 100 mm VAS, with 0 being the worst imaginable state and 100 being the best imaginable state.|Baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
1225250|NCT00701662|Secondary|Treatment Satisfaction at Baseline and Week 25|Treatment satisfaction was assessed using the Life Quality Index, which comprises 15 items rated on a 7-point scale (1 = worst rating, 7 = best rating) with a possible maximum score of 105. The highest score indicates the highest satisfaction with the impact of treatment on social factors. The 15 items were summarized to 4 scales: treatment interference, therapy-related problems, therapy setting, and treatment costs. The raw scores for these scales were transformed to a score ranging from 0 to 100, with 100 being the best score achievable.|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
1225251|NCT00701662|Secondary|Health-Related Quality of Life at Baseline and Week 25|"Assessed using a questionnaire on patients' satisfaction with current immunoglobulin G (IgG) treatment, treatment at home, and treatment at the hospital/doctor's office. The questions were answered by choosing a number between 1 (extremely good) and 7 (extremely bad).~Note: No patients received IgG treatment at the hospital/doctor's office at Week 25."|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
1225252|NCT00701662|Secondary|Mean Motor Function Score at Screening and Week 25|For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst).|Screening and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||Full Range|Mean
1225272|NCT00701363|Secondary|Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL||At weeks 24 and 48|n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
1225253|NCT00701662|Primary|Mean Overall MRC Score at Baseline and Week 24|The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement.|Baseline and week 24|The ITT data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.|||score on a scale||Full Range|Mean
1225254|NCT00701662|Secondary|Change From Baseline to the Completion Visit in Motor Function|"The change in motor function was determined at the completion visit compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method.~For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst). The baseline motor function score was calculated as the mean of the patient's assessments at Screening and Week 1. Negative values for change in motor function score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to the completion visit (up to week 25)|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||95% Confidence Interval|Mean
1225255|NCT00701662|Secondary|Mean Disability Score at Baseline and Week 24|Disability was measured using a modified Guy’s Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability.|Baseline and Week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||Full Range|Mean
1225256|NCT00701662|Secondary|Change From Baseline to Week 24 in Disability|"The change in disability score was determined at week 24 compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.~Disability was measured using a modified Guy’s Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability. Negative values for change in disability score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||95% Confidence Interval|Mean
1225257|NCT00701662|Primary|Change From Baseline to Week 24 in Muscle Strength|"The change in Medical Research Council (MRC) score was determined at week 24 compared to baseline using descriptive statistics and nonparametric, two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.~The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Baseline to week 24|The Intention-to-Treat (ITT) data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.|||score on a scale||95% Confidence Interval|Mean
1225258|NCT00701636|Primary|Mean Daptomycin Concentrations at 12, 18, 24, and 48 h|Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h|Hospital discharge or 7 days, whichever comes first|Based on sample sizes from previously published studies on antibiotic pk for CABG surgery.|||mcg/ml||Standard Deviation|Mean
1225259|NCT00701558|Secondary|Overall Survival|Overall survival was defined as the interval between the day of randomization and the date of death from any cause.|From the time of randomization until death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.|||weeks||95% Confidence Interval|Median
1225260|NCT00701558|Primary|Overall Response Rate (ORR)|Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the time of randomization until disease progression or death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.|||percentage of participants|||Number
1225261|NCT00701558|Primary|Time to Disease Progression|Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|From the time of randomization until disease progression or death (up to 193 weeks)]|Intention to treat (ITT) population included all participants who were randomized to treatment group.|||weeks||95% Confidence Interval|Median
1225262|NCT00701441|Other Pre-specified|Peroxynitrite Deposition in the Vascular Walls|A forearm biopsy will be collected to isolate human microcirculatory endothelial cells. The stain density of peroxynitrite, an indicator of oxidative stress, in the vascular walls is compared between pre-treatment and post treatment patient tissue. Also another comparison is made between pre-treatment and control tissue. The stain density is a software-generated measurement of pixel intensity and is considered to be an arbitrary unit. Higher numbers indicate greater density|baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and flow mediated dilation only.|||stain density units||Standard Error|Mean
1225263|NCT00701441|Primary|Flow Mediated Dilation|A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.|Baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and nitrotyrosine stain density values only.|||percentage change of vessel diamter||Standard Error|Mean
1225264|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Urine|Plasma samples were assayed for total urine GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal of <0.030 mg/mmoL of creatinine. Number of participants analyzed=participants with both baseline and post-baseline GL-3 urine clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.|||Percent change||Standard Deviation|Mean
1225265|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Plasma|Plasma samples were assayed for GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal plasma GL-3 level of 7.0 μg/mL. Number of participants analyzed=participants with both baseline and post-baseline GL-3 plasma clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.|||Percent change||Standard Deviation|Mean
1225266|NCT00701415|Primary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 52, Week 156 and Week 260 or early withdrawal and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was scored for GL-3 accumulation on a severity score-scale of none, mild, moderate, severe (0-1-2-3). Scores are categorized as normal (score = 0) or abnormal (score = 1, 2 or 3). Data was summarized in terms of number of participants with none/trace, mild, moderate and severe biopsy scores.|Baseline, Week 52, Week 156 and Week 260|Analysis was performed on Full analysis set (FAS), which included all randomized participants who received at least 1 infusion of study treatment.|||Percentage of participants|||Number
1225267|NCT00701389|Secondary|Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The number of participants who were discontinued from the study due to adverse event was summarized.|up to 10 weeks|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Participants|||Number
1225268|NCT00701389|Secondary|Number of Participants Who Experienced an Adverse Event During the Study|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 10 weeks)|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Participants|||Number
1225269|NCT00701389|Secondary|Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered telcagepant or placebo in either Periods 1, 2, 3, or 4 regardless of sequence.|||mmHg||95% Confidence Interval|Least Squares Mean
1225270|NCT00701389|Primary|Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered sumatriptan with telcagepant or sumatriptan alone in either Periods 1, 2, 3, or 4 regardless of sequence and had evaluable blood pressure data obtained.|||mmHg||95% Confidence Interval|Least Squares Mean
1225271|NCT00701363|Secondary|Subject Treatment Schedule Preference|"At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks.~At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.~Lan: Lanreotide~W: Week~Inj: Injection~Wks: Weeks~Phs: Phase~Grp: Group~evy: every"|||Percentage of subjects|||Number
1225274|NCT00701363|Secondary|Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit|"AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline.~IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline.~Correlation presented is a Spearman correlation (non parametric)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."|||Correlation coefficient||95% Confidence Interval|Number
1225275|NCT00701363|Secondary|Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48|The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.|At week 48 (End of Study)|"MITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."|||Percentage of subjects||95% Confidence Interval|Number
1225276|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (SF-36)|Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|ITT population. n = Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.|||Units on a scale||Standard Deviation|Mean
1225277|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (AcroQoL)|AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|"ITT population n = Number of subjects at the visit. Phase 1 only: These subjects participated only in phase 1 & did not move onto phase 2.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included"|||Units on a scale||Standard Deviation|Mean
1225278|NCT00701363|Secondary|Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)|Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).|At baseline, week 24 and week 48|"ITT population.~Number of Participants Analyzed:~Phase 1 in week 24: 3~Phase 2 (Group A) in week 24: 13~Phase 2 (Group B) in week 24: 69~Phase 2 (Group C) in week 24: 25~Phase 2 (Group A) in week 48: 13~Phase 2 (Group B) in week 48: 68~Phase 2 (Group C) in week 48: 26~NA = Not Applicable"|||Units on a scale||Standard Deviation|Mean
1225279|NCT00701363|Secondary|Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24||Baseline (visit 1)|"ITT population. n = Number of subjects at the visit.~These subjects entered in phase 2~One subject was not included in this analysis because IGF-1 was lower than 130% at week 24 but not in the second phase and one subject in group A had missing IGF-1 value at baseline."|||Percentage of ULN||95% Confidence Interval|Mean
1225280|NCT00701363|Secondary|Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C||Baseline (visit 1)|"MITT population.~One subject in Group A had missing IGF-1 value at baseline. One subject in Group B had missing IGF-1 value at week 48 and two subjects did not attend week 48 (early withdrawal). One subject in Group C had missing IGF-1 value at week 48."|||Percentage of ULN||95% Confidence Interval|Mean
1225281|NCT00701363|Secondary|Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval|IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline|Baseline (visit 1) and week 48|MITT population. One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.|||Percentage of ULN||Standard Deviation|Mean
1225282|NCT00701363|Secondary|Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels|The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48.|At week 48|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
1225283|NCT00701363|Secondary|Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks|The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.|During phase 2 of the study (up to week 48)|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
1225284|NCT00701363|Secondary|Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)|The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.|At week 24|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
1225285|NCT00701363|Primary|Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)|A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)|At week 48 (End of Study)|"Intention to Treat (ITT) population: All patients having received ≥1 study drug dose. Modified ITT (MITT) population: All subjects in the ITT population for whom group allocation was performed (included in Phase 2).~n = Number of subjects at the visit"|||Percentage of subjects||95% Confidence Interval|Number
1225578|NCT00699660|Primary|Completeness and Quality of PTSD Interview|total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment|Post-exam, same day||||percentage of criteria PTSD assessment||Standard Deviation|Mean
1225286|NCT00701311|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.~The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks||||participants|||Number
1225287|NCT00701129|Primary|Disability Index Assessed by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at End of Study|The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. It consists of all items of the original PEDI (197 functional skill items in 3 domains: self-care; mobility; and social function) and additional items in the functional skills, mobility, and self-care domains to reflect clinically relevant functional skills for children with Pompe disease. Each domain consisted of 2 subdomains: functional skill performance and caregiver assistance scale. Norm-based scoring was developed for these additional items, and scoring algorithms for the PEDI have been adjusted to reflect additional normative data collected for the Pompe PEDI. Total score range for each domain (mean of subdomains) and subdomain ranges from 0 to 100, where higher score indicates high capability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patient analyzed = number of patients with end of study Pompe PEDI assessment and n = number of patients with end of study assessment of specified category.|||units on a scale||Full Range|Median
1225288|NCT00701129|Primary|Motor Development Status Assessed by Alberta Infantile Motor Scale (AIMS) at End of Study|"AIMS is a 58-item reliable and valid measure of motor development for infants at risk for motor delay. It assesses infant movement in 4 positions (subscales): prone (reciprocal crawling); supine (moving hands to feet); sitting (sitting with arm support); and standing (pulls to stand). For each subscale, items were scored as observed or not observed. Item in the observed range create a motor window. When scoring, subscale scores are calculated by giving the child credit (1 point) for observed items within the motor window in addition to being given credit (1 point) for all of the less mature items before motor window. AIMS total score was calculated by summing the scores for 58 items and ranged from 0 to 58, with higher score indicating more mature motor development. Score was then compared with age-equivalent peers from normative sample and equivalence level age (in months) is reported. End of study refers to the last post baseline observation during study period (up to Week 79)."|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study AIMS assessment.|||months||Full Range|Median
1225289|NCT00701129|Primary|Gross Motor Disability Assessed by Gross Motor Function Measure-88 (GMFM-88) at End of Study|GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item is scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension is expressed as a percentage of the maximum score for that dimension. Total score is obtained by adding the percentage scores for each dimension and dividing the sum by the total number of dimensions. Total score ranges from 0% to 100%, where higher scores indicate better motor functions. A total score of <7.5% demonstrates gross motor disability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study GMFM-88 assessment.|||percentage of maximum total score||Full Range|Median
1225290|NCT00701129|Primary|Number of Patients With Ventilator Use at End of Study|Number of patients who had ventilator support at end of study was reported. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
1225291|NCT00701129|Primary|Number of Patients With Normal/Abnormal Left Ventricular Mass (LVM) Z-Score and LVM Index at End of Study|LVM Z-score and LVM index were assessed by ECHO. LVM Z-Score provides an indicator of degree of standard deviations from the mean in a normal distribution. Negative values indicate a smaller LVM than mean and values higher than 0 indicate a larger LVM than the mean. The normal range for LVM Z-Score is -2 to 2. Values <-2 or >2 indicate abnormal LVM Z-Score. LVM index is an index value derived by normalizing LVM by body surface area. LVM index provides evidence of cardiomyopathy. LVM index values <65 gram per meter^2 (g/m^2) were considered as normal and LVM index values >=65 g/m^2 were considered as abnormal. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
1225292|NCT00701129|Primary|Number of Patients Who Survived at End of Study||Baseline up to End of study (Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
1225293|NCT00701129|Primary|Number of Patients With Recombinant Human Acid Alfa-glucosidase (rhGAA) Inhibitory Antibody at End of Study|Patients with positive anti-rhGAA IgG antibody were assessed for the presence of inhibitory antibodies (inhibition of enzyme activity and inhibition of enzyme uptake). Enzyme-linked immunosorbent assay (ELISA) was used to measure inhibition of rhGAA enzymatic activity in vitro and a cell-based assay was used to measure the inhibition of the uptake of rhGAA in normal fibroblast cells by flow cytometry.|End of study (up to Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patients analyzed = patients with positive anti-rhGAA IgG antibody.|||participants|||Number
1225319|NCT00701051|Primary|Glucose Utilization (Pre/Post Intervention)|Insulin-stimulated glucose uptake|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
1225294|NCT00701129|Primary|Change From Baseline in Number of Patients With Anti-Recombinant Human Acid Alfa-glucosidase (Anti-rhGAA) Immunoglobulin G (IgG) Antibody at End of Study|Serum samples from patients were analyzed for the presence of anti-rhGAA IgG antibodies. End of study (EOS) refers to the last post baseline observation during study period (up to Week 79).|Baseline, End of Study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
1225295|NCT00701103|Secondary|Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)|Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND <5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.|Up to 2 years|The population consisted of all evaluable participants who received >90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.|||Percentage of Participants|||Number
1225296|NCT00701103|Secondary|Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab|It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).|Up to 2 years|The population consisted of all participants who received >90% of intended drug volume and had measurements at Baseline and at least once during treatment.|||Percentage of Participants|||Number
1225297|NCT00701103|Secondary|Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples|IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.|Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)|The population consisted of all evaluable participants who received >90% of intended drug volume and had IGF-1R tumor pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 2.5 mg/kg Q1W and Dalotuzumab 30 mg/kg Q3W treatment groups.|||H-score||Standard Deviation|Mean
1225298|NCT00701103|Secondary|Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples|IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.|Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)|The population consisted of all evaluable participants who received >90% of intended drug volume and had skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.|||H-score||Standard Deviation|Mean
1225299|NCT00701103|Primary|Mean Trough Serum Concentration (Ctrough) of Dalotuzumab|The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.|Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing|The population consisted of all evaluable participants who received >90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.|||ug/mL||Standard Deviation|Mean
1225300|NCT00701103|Primary|Mean Serum Clearance of Dalotuzumab|Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had mean serum clearance pharmacokinetic measurements at Baseline and at least once during treatment.|||mL/min/kg||Standard Deviation|Mean
1225301|NCT00701103|Primary|Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab|AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.|||mg*hr/mL||Standard Deviation|Mean
1225320|NCT00701051|Secondary|Baseline 2-hour Postprandial Glucose||baseline||||mg/dl||Standard Error|Mean
1225321|NCT00701051|Primary|Baseline Glucose Utilization|Insulin-stimulated glucose uptake|baseline||||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
1225607|NCT00699413|Secondary|Percent Body Fat||Measured at baseline and 12 weeks|||||||
1225302|NCT00701103|Primary|Mean Terminal Half-life (t1/2) of Dalotuzumab|Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had t1/2 pharmacokinetic measurements at Baseline and at least once during treatment.|||Hours||Full Range|Mean
1225303|NCT00701103|Primary|Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)|Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.|Up to 3 weeks|The population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1225304|NCT00701090|Secondary|Percent of Patients With A1C <6.5% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percentage of Participants|||Number
1225305|NCT00701090|Secondary|Percent of Patients With A1C <7.0% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percentage of Participants|||Number
1225306|NCT00701090|Secondary|Change From Baseline in Body Weight at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|All patients who took at least one dose of study therapy and had body weight measurements at both baseline and Week 30.|||Kilograms||95% Confidence Interval|Least Squares Mean
1225307|NCT00701090|Secondary|Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30||Week 0 to Week 30|All patients who took at least one dose of study therapy.|||Percentage of Participants|||Number
1225308|NCT00701090|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||mg/dL||95% Confidence Interval|Least Squares Mean
1225309|NCT00701090|Primary|Change From Baseline in HbA1c at Week 30|Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percent||95% Confidence Interval|Least Squares Mean
1225310|NCT00701064|Secondary|Posttraumatic Stress Disorder Checklist (PCL-M)|Self-rated PTSD scale with 17 items (rated 1-5) with range of 17-85. Higher score = worse severity of PTSD. Reported are decreases from baseline to end-of-study.|Baseline to following 4-week treatment||||decrease in units on scale||Standard Error|Mean
1225311|NCT00701064|Primary|Clinical Global Impressions Scale (CGI)|The CGI assesses baseline severity on a 7-point scale, and change on 7-point scale. (1=normal; 4=moderately ill; 7= among the most severely ill). Change: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse|Baseline severity to post-treatment (4 weeks later) Change||||units on scale||Standard Error|Mean
1225312|NCT00701064|Primary|Clinical Assessed PTSD Scale (CAPS-2)|The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.|Mean change from baseline to post-treatment (5-6 weeks later)|Separate analysis will be conducted to include drop-outs and exclusions. reported are end of study data|||change in units on scale||Standard Deviation|Mean
1225313|NCT00701051|Secondary|Body Composition (%Fat)||baseline, 24 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||percentage of fat||Standard Error|Mean
1225314|NCT00701051|Secondary|Cardiorespiratory Fitness|Maximal oxygen consumption|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||L/Min||Standard Error|Mean
1225315|NCT00701051|Primary|Skeletal Muscle Capillarization (Pre/Post Intervention)||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||capillaries/mm2||Standard Error|Mean
1225316|NCT00701051|Primary|Baseline Skeletal Muscle Capillarization||baseline||||capillaries/mm2||Standard Error|Mean
1225317|NCT00701051|Secondary|Baseline Cardiorespiratory Fitness|maximal oxygen consumption|baseline||||L/min||Standard Error|Mean
1225318|NCT00701051|Secondary|2-hr Post-prandial Plasma Glucose Level||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||mg/dL||Standard Error|Mean
1225608|NCT00699413|Secondary|Insulin Activity||Measured at baseline and 12 weeks|||||||
1225609|NCT00699413|Primary|Body Mass Index / Weight||measured at baseline and 12 weeks||||kg/m^2||Standard Deviation|Mean
1225322|NCT00701038|Primary|Left Ventricular Ejection Fraction Improvement|Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.|baseline and again after three nights in hospital|ITT|||percent change||Standard Error|Mean
1225323|NCT00700999|Primary|Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later.|Baseline and 12 weeks|The number of participants analyzed is only 17 in each arm. The total number of participants in the Intervention group who completed fMRI scans pre-treatment and post treatment is only 19, in the Combat Exposed Control Group it is 18. Three of the participants scans were removed from data analysis due to the level of movement during the scan.|||percent change in BOLD signal||Standard Deviation|Mean
1225324|NCT00700973|Primary|Addiction Severity Index Legal Composite|Scores range from 0 to 1, with higher scores indicating more severe legal problems.|One year post-intervention||||units on a scale||Standard Deviation|Mean
1225325|NCT00700817|Secondary|Hypoglycaamic Episodes, Weeks 52-78|Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 52-78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||episodes|||Number
1225326|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
1225327|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
1225328|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
1225329|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
1225330|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
1225331|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
1225332|NCT00700817|Secondary|Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 52, Week 78|Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Deviation|Mean
1225333|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 52|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Error|Least Squares Mean
1226388|NCT00692198|Secondary|Health Care Utilization|Health care utilization is measured by the rate of all hospitalizations.|Through study completion. Median follow-up was 18.4 months.||||Hospitalizations per 100 person-years|||Number
1225334|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 26|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Error|Least Squares Mean
1225335|NCT00700817|Secondary|Mean Change in Pulse From Week 52 to Week 78|Mean change in pulse from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||beats/minute||Standard Deviation|Mean
1225336|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 52|Calculated as an estimate of the mean change from baseline in pulse at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1225337|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 26|Calculated as an estimate of the mean change from baseline in pulse at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||beats/minute||Standard Error|Least Squares Mean
1225338|NCT00700817|Secondary|Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78|Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmHg||Standard Deviation|Mean
1225339|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1225340|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1225341|NCT00700817|Secondary|Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78|Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmHg||Standard Deviation|Mean
1225342|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52|Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1225343|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26|Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1225344|NCT00700817|Secondary|Mean Change in Waist Circumference From Week 52 to Week 78|Mean change in Waist Circumference from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||kg||Standard Deviation|Mean
1225345|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 52|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||participants||Standard Error|Least Squares Mean
1225346|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 26.|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm||Standard Error|Least Squares Mean
1225347|NCT00700817|Secondary|Mean Change in Waist to Hip Ratio From Week 52 to Week 78|Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||cm/cm||Standard Deviation|Mean
1225348|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 52|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm/cm||Standard Error|Least Squares Mean
1225349|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 26.|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm/cm||Standard Error|Least Squares Mean
1225350|NCT00700817|Secondary|Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.|Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
1225351|NCT00700817|Secondary|Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pg/mL||Standard Error|Least Squares Mean
1225352|NCT00700817|Secondary|Mean Change From Baseline in Adiponectin at Week 26.|Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mcg/mL||Standard Error|Least Squares Mean
1225353|NCT00700817|Secondary|Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pmol/L||Standard Error|Least Squares Mean
1225354|NCT00700817|Secondary|Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.|Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pg/mL||Standard Error|Least Squares Mean
1225355|NCT00700817|Secondary|Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.|Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||U/L||Standard Error|Least Squares Mean
1225356|NCT00700817|Secondary|Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26|Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mg/L||Standard Error|Least Squares Mean
1225357|NCT00700817|Secondary|Mean Change in Apolipoprotein B From Week 52 to Week 78|Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1225358|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 52|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||g/L||Standard Error|Least Squares Mean
1225359|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 26|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||g/L||Standard Error|Least Squares Mean
1225360|NCT00700817|Secondary|Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78|Mean change in free fatty acids (FFA) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1225361|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225362|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225363|NCT00700817|Secondary|Mean Change in Triglycerides (TG) From Week 52 to Week 78|Mean change in triglycerides (TG) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1225364|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 52|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225365|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 26|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225366|NCT00700817|Secondary|Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78|Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1225367|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225368|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225369|NCT00700817|Secondary|Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78|Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1225370|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225371|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225372|NCT00700817|Secondary|Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78|Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1225373|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225374|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225375|NCT00700817|Secondary|Mean Change in Total Cholesterol From Week 52 to Week 78|Mean change in total cholesterol from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1225376|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 52|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225377|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 26|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225378|NCT00700817|Secondary|Mean Change in Beta-cell Function From Week 52 to Week 78|Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage point||Standard Deviation|Mean
1225379|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 52|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
1225380|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 26|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
1225381|NCT00700817|Secondary|Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78|Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1225382|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78|Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225383|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225384|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1225385|NCT00700817|Secondary|Mean Change in Body Weight From Week 52 to Week 78|Mean change in body weight from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||kg||Standard Deviation|Mean
1225386|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 52|Calculated as an estimate of the mean change from baseline in body weight at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||kg||Standard Error|Least Squares Mean
1225387|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 26|Calculated as an estimate of the mean change from baseline in body weight at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||kg||Standard Error|Least Squares Mean
1225388|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage of subjects|||Number
1225389|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1225390|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1225391|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1225392|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage of subjects|||Number
1225393|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1225394|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1225395|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1225396|NCT00700817|Primary|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||Percentage point of total HbA1c||Standard Deviation|Mean
1225397|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1225398|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1225399|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1225400|NCT00700804|Primary|Calcium Absorption|Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time|17 weeks|Only participants which completed both protein diet periods were included in the statistical analysis|||percentage of Calcium absorbed||Standard Deviation|Mean
1225401|NCT00700804|Secondary|Serum Insulin-like Growth Factor 1 (IGF-1)||7 weeks||||nanomoles per liter (nmols/L)||Standard Error|Geometric Mean
1225617|NCT00699400|Secondary|Oocyte Level Live Birth Rate|Oocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes|Birth of one or more live babies||||% of all oocytes thawed|Participants||Number
1225402|NCT00700752|Primary|Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).|Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.|after 4 weeks of lens wear||||Units on a scale||Standard Error|Least Squares Mean
1225403|NCT00700739|Secondary|Device Related Adverse Events|The proportion of subjects with device related adverse events as reported throughout the duration of the study.|Intra-operatively to 24 months post-operative||||Percentage of subjects|||Number
1225404|NCT00700739|Secondary|Cervical Range of Motion Measured Radiographically at 6 Months|Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs.|6 months|Only 2 subjects in the cTDR and 2 subjects in the ACDF treatment groups were available for this outcome measure.|||degrees||Standard Deviation|Mean
1225405|NCT00700739|Secondary|Foraminal Height Measured Radiographically at 24 Months|Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI).|24 months|The study was terminated prior to 24 months therefore there are no results for this endpoint.||||||
1225406|NCT00700739|Secondary|Maintenance of Disc Height Measured Radiographically at 6 Months|Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm).|6 months|Only 2 subjects in the cTDR and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.|||mm||Standard Deviation|Mean
1225407|NCT00700739|Secondary|Adjacent Level Degeneration Measured Radiographically at 24 Months|Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA.|24 months|Study was terminated prior to 24 months therefore there are no results for this endpoint.||||||
1225408|NCT00700739|Secondary|Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months|Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view.|6 months|Only 2 subjects in the Cervical Total Disc Replacement (cTDR) and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.|||degrees||Standard Deviation|Mean
1225409|NCT00700739|Secondary|Work Status Assessed at 12 Months|The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 12 subjects in the ACDF treatment groups were available for this outcome.|||Percentage of Subjects|||Number
1225410|NCT00700739|Secondary|Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months|The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||Percentage of Subjects|||Number
1225411|NCT00700739|Secondary|Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1225412|NCT00700739|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1225413|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 17 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1225414|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1225415|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1225416|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1225417|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1225418|NCT00700739|Primary|Overall Patient Success|Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.|12 months|Overall Patient Success is composed of several outcome measures, some of which require a valid pre-operative and 12-month post-operative score. Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for the Overall Patient Success calculation.|||Percentage of subjects|||Number
1225419|NCT00700713|Other Pre-specified|Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1225420|NCT00700713|Other Pre-specified|Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1225421|NCT00700713|Primary|Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1225422|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 2|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
1225423|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
1225424|NCT00700635|Secondary|Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1225425|NCT00700635|Secondary|Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Percentage of Participants|||Number
1225426|NCT00700635|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Percentage of Participants|||Number
1225427|NCT00700622|Primary|Change From Baseline in HbA1c to Week 16|Change from Baseline in glycosylated hemoglobin at Week 16|Baseline to Week 16|Intent to Treat with Available Data at Week 16|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1225428|NCT00700570|Secondary|Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was to be confirmed at a minimum of 4 weeks after the first documented response. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, as well as no new target lesions. Disease progression or PD was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Non-evaluability for tumor assessment was also documented when applicable. The percentage of participants with each level of response was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
1225429|NCT00700570|Secondary|Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was confirmed at a minimum of 4 weeks after the first documented response. The percentage of participants with confirmed CR or PR was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
1225430|NCT00700570|Secondary|Time to Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Time to disease progression was defined as the time from first dose to time of disease progression. Participants without progression were censored at the time of last tumor assessment. Time to disease progression was estimated using Kaplan-Meier analysis and expressed in months.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT)|ITT Population.|||months||95% Confidence Interval|Median
1225431|NCT00700570|Secondary|Percentage of Participants With Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20 percent (%) increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT])|ITT Population.|||percentage of participants|||Number
1225432|NCT00700570|Primary|Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases|Participants were assessed via microscopic and macroscopic examination for tumor resectability after completion of 5 cycles of neoadjuvant treatment. Unresectable participants exhibited any of the following criteria: greater than or equal to (≥) 4 liver metastases; location and/or distribution of metastatic disease within the liver considered unsuitable for resection with clear margins; liver involvement precluding resection, in the setting of adequate parenchymal volume for otherwise viable liver function in the immediate postoperative period; and inability to maintain adequate circulation for viable liver function. Participants who had not met any of the above criteria at the end of 5 cycles underwent surgical resection. The percentage of participants with conversion from initially unresectable to resectable liver metastases was calculated as [number of participants eligible for surgical resection divided by the number analyzed] multiplied by 100.|After 5 cycles of neoadjuvant treatment (10 weeks)|ITT Population.|||percentage of participants|||Number
1225433|NCT00700440|Secondary|1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival||5 year|||||||
1225434|NCT00700440|Primary|3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy|"The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.~Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria."|3 months||||participants with loco-regional control|||Number
1225435|NCT00700427|Secondary|Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49|The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state “worse than dead.” A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1225436|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|BRIEF-A:Informant is a 75-item third-party observer’s view of the participants’ executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1225437|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1225438|NCT00700427|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49|CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1225439|NCT00700427|Secondary|Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49|The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1225440|NCT00700427|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49|The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.|Baseline (Week 24), Week 49|All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1225441|NCT00700427|Secondary|Number of Days Until Relapse|"Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.~CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants)."|Baseline (Week 24) up to Week 49|Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).|||days||Standard Deviation|Mean
1225454|NCT00700310|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase.|||Percent Change||Full Range|Median
1227185|NCT00686205|Primary|PRISM HIV O Plus Test Data for Specificity|Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.|12 months|The analysis was per the protocol.|||participants|||Number
1225442|NCT00700427|Primary|Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period|Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.|Baseline (Week 24) up to Week 49|Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).|||percentage of responders|||Number
1225443|NCT00700401|Secondary|Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48|Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.|Baseline, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.|||Percent change||Standard Error|Mean
1225444|NCT00700401|Secondary|Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48|Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.|At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.|||Percent change||Standard Error|Mean
1225445|NCT00700401|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 48 weeks|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||participants|||Number
1225446|NCT00700401|Secondary|Percentage of Participants With Positive Predictive Value|Positive predictive value is defined as participants with RVR who did not achieve SVR.|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1225447|NCT00700401|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.|At week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1225448|NCT00700401|Secondary|Percentage of Participants With Virological Response at Week 24|Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).|At Week 24|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1225449|NCT00700401|Secondary|Percentage of Participants With Rapid Virological Response at Week 4|Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.|At Week 4|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1225450|NCT00700401|Primary|Percentage of Participants With Sustained Virological Response at Week 48|Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1225451|NCT00700375|Primary|Occurrence of Contrast-induced Nephropathy|The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.|after procedure and 1,2-3day after procedure||||participants|||Number
1225452|NCT00700310|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set|||Percent Change||Full Range|Median
1225453|NCT00700310|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set.|||Percentage of Participants|||Number
1227298|NCT00685295|Primary|Pain Reduction|Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).|60 minutes||||Participants|||Count of Participants
1225455|NCT00700271|Secondary|Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for 5 minutes; the investigator then took 3 blood pressure and 1 pulse rate reading. The measurements were recorded at 1-2 minute intervals. BP Control is defined as msSBP/msDBP <149/90 mmHg and/or <130/80 mmHg if diabetes or renal insufficiency (RI).|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||Percentage of participants|||Number
1225456|NCT00700271|Secondary|Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||Percentage of participants|||Number
1225457|NCT00700271|Secondary|Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||Percentage of Participants|||Number
1225458|NCT00700271|Secondary|Percentage of Participants With 24-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 125/80 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||Percentage of Participants|||Number
1225459|NCT00700271|Secondary|Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Screening visit (Week -4, prior to 4-week open-label screening phase) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Mean
1225460|NCT00700271|Secondary|Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
1225461|NCT00700271|Secondary|Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
1225462|NCT00700271|Secondary|Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
1225610|NCT00699400|Secondary|Number of Miscarriages|Number of pregnancy outcomes reported as spontaneous abortions|Anytime after embryo transfer|Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.|||Number of Miscarriages|Participants||Number
1225463|NCT00700271|Secondary|Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
1225464|NCT00700271|Secondary|Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
1225465|NCT00700271|Primary|Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
1225466|NCT00700180|Secondary|Overall Survival - Time to Event|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.|Baseline, weekly to death due to any cause, or to end of study|ITT Population.|||months||95% Confidence Interval|Median
1225467|NCT00700180|Secondary|Overall Survival - Percentage of Participants With an Event|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.|Baseline, weekly to 28 days after last dose of study treatment, every 8 weeks thereafter to death due to any cause|ITT population.|||percentage of participants|||Number
1225468|NCT00700180|Secondary|Duration of Response - Time to Event|The median time, in months, from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR). Median Duration of Response was estimated using the Kaplan-Meier method.|Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.|ITT population: only participants with an objective tumor response (CR or PR) were included in the analysis.|||months||95% Confidence Interval|Median
1225469|NCT00700180|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response is defined as time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR).|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT population; only participants with an objective tumor response (CR or PR) were included in the analysis.|||percentage of participants|||Number
1225470|NCT00700180|Secondary|Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks|Percentage of participants with measurable disease at baseline who on assessment achieved CR, PR, or SD according to RECIST. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met. For participants with SD, follow-up assessments must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT Population|||percentage of participants||95% Confidence Interval|Number
1225486|NCT00700063|Primary|Incidence of Scarring Following Study Medication Application|The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
1225471|NCT00700180|Secondary|Percentage of Participants With Objective Response|Percentage of participants with CR or PR according to RECIST criteria. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses were confirmed no less than 4 weeks after the criteria for response were first met.|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT Population. Data for 12 participants (3 at 7.5 mg and 9 at 15 mg) were excluded for reasons including but not limited to: no study treatment (ST), no postbaseline tumor assessment (TA), non-protocol defined antineoplastic therapy before first TA, first TA >70 days after last dose of last ST, last TA less than (<) 42 days from start of therapy.|||percentage of participants||95% Confidence Interval|Number
1225472|NCT00700180|Secondary|Progression-Free Survival - Time to Event|PFS was defined as the time between randomization and disease progression or death due to any cause. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization. Disease progression was evaluated according to the RECIST using CT scans, MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method.|Baseline, Day 1, weekly to disease progression|ITT Population.|||months||95% Confidence Interval|Median
1225473|NCT00700180|Secondary|Progression-Free Survival - Percentage of Participants With an Event|PFS was defined as the time between randomization and progressive disease (PD) according to RECIST criteria, or death due to any cause. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. Disease progression was evaluated according to the RECIST using computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization.|Baseline, Day 1, weekly to disease progression|ITT population.|||percentage of participants|||Number
1225474|NCT00700180|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level|Overall response was analyzed and correlated within dichotomized (low- and high-level) baseline plasma biomarker (basic fibroblast growth factor [bFGF], E-selection, intracellular adhesion molecule [ICAM], placental growth factor [PlGF], vascular endothelial growth factor A [VEGF A], vascular endothelial growth factor receptor [VEGFR]-1, and VEGFR-2) subgroups: low-level equals (=) less than or equal to (≤) median baseline level, high-level=greater than (>) median baseline level. Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.0 CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease; no new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after criteria for response were first met|Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.|Biomarker Evaluable Protein Plasma (BEP) Population: Participants in the ITT population who started at least 1 dose of bevacizumab and had a non-missing baseline biomarker level determined for at least 1 biomarker. n (number) equals (=) number of participants assessed for the specified biomarker.|||percentage of participants|||Number
1225475|NCT00700141|Secondary|Pharmacoeconomic Benefits as Assessed by the Surgeon|Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)|peri- and post-surgery until hospital discharge|"All 482 patients included and treated with TachoSil®, missing values not imputed.~Multiple answers possible."|||participants|||Number
1225476|NCT00700141|Primary|Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales|Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)|after surgery|"All 482 patients included and treated with TachoSil® [= Intention to Treat population (ITT)], missing values not imputed.~For one patient missing information in all three scales (Handling, Utility and Satisfaction in the Operation)"|||Units on a scale||Standard Deviation|Mean
1225477|NCT00700115|Primary|Plasma Viral Loads (HIV-1 RNA PCR)|Percentage subjects with undetectable Plasma viral loads|baseline to week 48||||percentage of subjects||95% Confidence Interval|Number
1225478|NCT00700115|Secondary|To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects||48 weeks|intention to treat|||mg/dL||Standard Error|Mean
1225479|NCT00700102|Secondary|Response Rate: Participants With Response Status Based on RECIST Criteria|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment."|within 6.5 years|Participants with measurable disease|||percentage of participants||95% Confidence Interval|Number
1225480|NCT00700102|Secondary|Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria||within 6.5 years|Participants with measurable disease|||percentage of participants||95% Confidence Interval|Number
1225481|NCT00700102|Secondary|Progression Free Survival: Time to Event||within 6.5 years|Unstratified intention to treat population|||Months||Full Range|Median
1225482|NCT00700102|Secondary|Participants With Progression Free Survival Event||within 6.5 years|Unstratified intention to treat population|||participants|||Number
1225483|NCT00700102|Secondary|Overall Survival: Months From Time of First Line Therapy||within approximately 9.6 years||||months||95% Confidence Interval|Median
1225484|NCT00700102|Primary|Overall Survival: Time From Randomization to Death From Any Cause||within 6.5 years|Intention to treat|||months||95% Confidence Interval|Median
1225485|NCT00700063|Primary|Complete Clearance Rate of AK Lesions;|Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area|Day 57||||participants|||Number
1225487|NCT00700063|Primary|Incidence of Scarring Following Study Medication Application|The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
1225488|NCT00700063|Primary|Incidence of Hypopigmentation Following Study Medication Application|The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
1225489|NCT00700063|Primary|Incidence of Hypopigmentation Following Study Medication Application|The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
1225490|NCT00700063|Primary|Incidence of Hyperpigmentation Following Study Medication Application|The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
1225491|NCT00700063|Primary|Incidence of Hyperpigmentation Following Study Medication Application|The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
1225492|NCT00700063|Primary|Incidence Rate and Severity of LSRs Following Study Medication Application|"The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.~The actual value and change from baseline in the composite LSR score were also summarized."|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||units on a scale||Standard Deviation|Mean
1225493|NCT00700063|Primary|Incidence Rate and Severity of LSRs Following Study Medication Application|"The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.~The actual value and change from baseline in the composite LSR score were also summarized."|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||scores on a scale||Standard Deviation|Mean
1225494|NCT00700063|Primary|Incidence of SAE Recorded Throughout the Study|Incidence of SAE recorded throughout the study|57 days|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
1225495|NCT00700063|Secondary|Efficacy (Clearance of AK Lesions) Partial Clearance Rate|Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp|57 days||||participants|||Number
1225496|NCT00700063|Primary|Incidence of AEs Recorded Throughout the Study|Incidence of AEs recorded throughout the study|57 days|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
1225497|NCT00700011|Primary|To Determine the Non-hematologic Toxicity Profile of This Dose Schedule (Grade 2 and Above)|Assess for adverse events in all the patients receiving the Clofarabine at the dose schedules described in the protocol (CTCAE 3.0 used).|biweekly for duration of treatment , an average of 3 months|All participants considered.|||participants|||Number
1225498|NCT00700011|Primary|Determine Frequency and Duration of Bone Marrow Responses to IV Clofarabine|The International Working Group response criteria was used. Complete remission is defined as <5 % marrow blasts without evidence of dysplasia and normalization of the peripheral blood counts, including hemoglobin >11 g/dL, neutrophil count of >1 x 10^9/L. and platelet count of >100 x 10^9/L. Patients must also be transfusion-independent and not require any recombinant erythropoietin. Partial remission (PR) is defined as: satisfying complete remission criteria if abnormal before treatment, except that blasts are reduced by 50% or more compared to pretreatment levels, but still >5 %. Stable disease is defined as: failure to achieve at least a PR but without evidence of disease progression for at least 8 weeks.Progression of disease is defined as: disease progression with worsening cytopenias. Best response of these patients is used in the determination for this outcome below.|2-3 months|All patients considered except one on the 5 mg/m2 arm who we didn't have enough time to assess response as he died within 2 weeks after receiving cycle 1.|||participants|||Number
1225499|NCT00700011|Secondary|Number of Participants With DNA Hypomethylation During the Study|Since we previously observed decreases in DNA methylation in tumor cells after in vitro treatment with Clofarabine, we compared the long interspersednuclear element-1 methylation of genomic DNA obtained from CD3-depletedperipheral blood mononuclear cells between day 1 and day 5 of each cycle of Clofarabine.|assessed twice per cycle|All participants were considered except one patient on 5 mg/m2 arm who died within 2 weeks after cycle 1, so this was unassessable.|||participants|||Number
1225500|NCT00700011|Primary|Improvement in Peripheral Blood Count and Reduction in Number of Transfusions|Hematologic improvement will be an increased Hemoglobin of 1.5 g/dL or a reduction in the need for PRBC transfusions by at least 4 units over an 8 week period, at least 100% increase and an ANC of >0.5 x 10^9/L and an absolut platelet count increase of >30 x 10^9/L for patients who start at > 20 x 10^9/L, or increase from <20 x 10^9/L to >20 x 10^9/L and by at least 100%.|2-3 months|All patients considered for analysis except for one on the 5 mg/m2 arm who died within 2 weeks after cycle one making this unassessable for that patient.|||participants|||Number
1225501|NCT00699998|Secondary|Summary of All Deaths|All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.|Randomization through end of study (30-month visit)|All randomized participants|||participants|||Number
1225502|NCT00699998|Secondary|Economic and Quality of Life Outcomes|Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.|Baseline and follow-up (24 months)|All randomized participants (combined <75 years and 75 years and older) with SAQ data.|||units on a scale||Standard Deviation|Mean
1225503|NCT00699998|Secondary|Genotyping Related to Drug Metabolism|Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.|Baseline|All randomized participants who provided a DNA sample.|||percentage participants with geneotype|||Number
1225504|NCT00699998|Secondary|Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)|C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.|Day 30 and Month 6|All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline CRP measurement at Day 30 or 6 Months.|||milligrams per liter (mg/L)||Standard Error|Geometric Mean
1225505|NCT00699998|Secondary|Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)|Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.|Day 30 and 6 Months|All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline BNP measurement at Day 30 or 6 Months.|||picograms per milliliter (pg/mL)||Standard Error|Geometric Mean
1225506|NCT00699998|Secondary|Platelet Aggregation Measures|Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.|Day 30 and 12 Months|All participants who received at least 1 dose of study drug, and had a baseline and post-baseline PRU measurement at Day 30 or Month 12.|||P2Y12 Reaction Units (PRU)||Standard Error|Least Squares Mean
1225507|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke|The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants|||percentage of participants with an event|||Number
1225508|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)|The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants|||percentage of participants with an event|||Number
1225509|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of CV Death and MI|The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants|||percentage of participants with an event|||Number
1225530|NCT00699816|Primary|Recurrence Free Survival(RFS)|RFS was measured from the date of randomization to the first recurrence or to death from any cause.|Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||months||95% Confidence Interval|Median
1225510|NCT00699998|Primary|Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke|The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants|||percentage of participants with an event|||Number
1225511|NCT00699972|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. One subject in Arm 3 was treated for 1 day prior to being excluded.|||Percent Change||Full Range|Median
1225512|NCT00699972|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. One subject in Arm 3 was treated for 1 day prior to being excluded.|||Percentage of Participants|||Number
1225513|NCT00699972|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase. One subject in Arm 3 was treated for 1 day prior to being excluded.|||Percent Change||Full Range|Median
1225514|NCT00699907|Primary|Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Stroma|ErbB4 levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
1225515|NCT00699907|Primary|Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Epithelium|ErbB4 levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
1225516|NCT00699907|Primary|Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Endosalpingiosis|ErbB4 levels were measured by immunohistochemistry (IHC).|Surgery||||Histo-score (H-Score)||Full Range|Median
1225517|NCT00699907|Primary|Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma|CSF-1R levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
1225518|NCT00699907|Primary|Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium|CSF-1R levels were measured by immunohistochemistry (IHC).|Surgery||||Histo-score (H-Score)||Full Range|Median
1225519|NCT00699907|Primary|Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis|CSF-1R levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
1225520|NCT00699907|Primary|Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma|CSF-1 levels were measured by immunohistochemistry (IHC).|Surgery||||Histo-score (H-Score)||Full Range|Median
1225521|NCT00699907|Primary|Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium|CSF-1 levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
1225522|NCT00699907|Primary|Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis|"CSF-1 levels were measured by immunohistochemistry (IHC).~The modified H-Score assess extent of nuclear immunoreactivity applicable to steroid receptors.~The modified H-scores total range is 0-300. A lower modified H-score indicates weakly staining nuclei. A higher modified H-score indicated strongly staining nuclei.~This applies to all measures."|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Modified H-Score||Full Range|Median
1225523|NCT00699842|Secondary|Safety With Dose Escalation|Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.|2 years|||||||
1225524|NCT00699842|Primary|Determine CR, PR, and Rate of Stable Disease in MDS Patients|Determine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in >10mg doses of lenalidomide|2 years|||||||
1225525|NCT00699816|Secondary|Cancer-specific Survival Rate|Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.|Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||percentage of participants|||Number
1225526|NCT00699816|Secondary|Overall Survival(OS) Rate|Overall survival rate was measured from the date of randomization until death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||percentage of participants|||Number
1225527|NCT00699816|Primary|Recurrence Free Survival(RFS) Rate|RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||percentage of participants|||Number
1225528|NCT00699816|Secondary|Cancer-specific Survivals|Cancer-specific survival was measured from the date of randomization until death resulting from HCC.|Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||months||95% Confidence Interval|Median
1225529|NCT00699816|Secondary|Overall Survival(OS)|Overall survival was measured from the date of randomization until death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||months||95% Confidence Interval|Median
1225531|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139)|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at follow-up visit 8, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Follow-up Visit 8 (Week 139)|The ITT population was all randomized subjects with with EQ-5D analyzed.|||Participants|||Number
1225532|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 24, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Week 24|The ITT population was all randomized subjects with with EQ-5D analyzed.|||Participants|||Number
1225533|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 16, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Week 16|The ITT population was all randomized subjects with with EQ-5D analyzed.|||Participants|||Number
1225534|NCT00699751|Other Pre-specified|Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. Total possible score was 108; a higher score indicates a better quality of life. The changes from baseline in the FACT-G total score (physical, social/family, emotional, and functional well-being) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -108 to 108.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225535|NCT00699751|Other Pre-specified|Absolute Scores for Functional Assessment of Cancer Therapy – General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. The FACT-G absolute total score (physical, social/family, emotional, and functional well-being) was calculated at Week 16, Week 24, and Follow-up Visit 2. FACT-G Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB). Score ranges from 0 (worst) to 108 (best).|At Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225536|NCT00699751|Other Pre-specified|Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. Total possible score was 156; a higher score indicates a better quality of life. The changes from baseline in the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -156 to 156.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225537|NCT00699751|Other Pre-specified|Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score of the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) was calculated at Week 16, Week 24, and Follow-up Visit 2.FACT-P Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 156 (best).|At Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225538|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Follow-up Visit 2.|At Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225539|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 24.|At Week 24|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225648|NCT00699218|Secondary|Inventory of Depressive Symptomatology|Self reported depression scale range 0-84. Questionnaire administered at 1,2, and 3 weeks (end of treatment). We also did a 5 week follow-up. The higher scores indicate greater or more severe depression.|5 weeks||||units on a scale||Standard Deviation|Mean
1225540|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 16.|At Week 16|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225541|NCT00699751|Other Pre-specified|Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Possible scores were 0 to 104; the higher the score, the better the quality of life. The changes from baseline (range -104 to 104) in the domain FACT-P TOI were summarized using descriptive statistics at Week 16, Week 24, and Follow-up Visit 2.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225542|NCT00699751|Other Pre-specified|Absolute Scores for Functional Assessment of Cancer Therapy – Prostate (FACT-P) Trial Outcome Index (TOI)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Prostate Cancer Trial Outcome Index (TOI): Physical Well-being (PWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 104 (best).|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
1225543|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 24|Participants in The ITT population and with ECOG analyzed|||Participants|||Number
1225544|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 16|Participants in The ITT population and with ECOG analyzed|||Participants|||Number
1225545|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 8|Participants in The ITT population and with ECOG analyzed|||Participants|||Number
1225546|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 0|Participants in The ITT population and with ECOG analyzed|||Participants|||Number
1225547|NCT00699751|Secondary|Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline|ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.|From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225548|NCT00699751|Secondary|Time to Occurrence of First Start of Any Other Anti-cancer Treatment|The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225611|NCT00699400|Secondary|Number of Clinical Pregnancies|Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.|At time of ultrasound after embryo transfer|Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.|||Number of Clinical Pregnancies|Participants||Number
1225549|NCT00699751|Secondary|Time to Occurrence of First Spinal Cord Compression|The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first spinal cord compression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225550|NCT00699751|Secondary|Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention|The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225551|NCT00699751|Secondary|Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral|The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225552|NCT00699751|Secondary|Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms|The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first use of radioisotopes until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225553|NCT00699751|Secondary|Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms|The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first EBRT until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225554|NCT00699751|Secondary|Time to First Skeletal Related Event (SRE)|A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first first SRE until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225555|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period|PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of [(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline to End of Treatment (Week 24; 4 weeks post last injection)|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
1225556|NCT00699751|Secondary|Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|PSA level was measured in subject’s blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)*100|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
1225557|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in PSA up to Week 12|PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of [(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline up to Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
1225558|NCT00699751|Secondary|Percentage Change From Baseline in PSA at Week 12|PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)*100|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percent change||Standard Error|Least Squares Mean
1225559|NCT00699751|Secondary|Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
1225560|NCT00699751|Secondary|Percentage of Participants With PSA Response at Week 12|PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
1225574|NCT00699699|Primary|Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks|Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)|Baseline and after 6 weeks of treatment|There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks|||Percentage of participants|||Number
1225561|NCT00699751|Secondary|Time to Prostate Specific Antigen (PSA) Progression|The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later|From randomization to first PSA progression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
1225562|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment|ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of [(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline During the 24 Week Treatment|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
1225563|NCT00699751|Secondary|Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)*100|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure|||Percent change||Standard Error|Least Squares Mean
1225564|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in Total ALP up to Week 12|ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of [(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline to Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
1225565|NCT00699751|Secondary|Percentage Change From Baseline in Total ALP at Week 12|ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)*100|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
1225566|NCT00699751|Secondary|Percentage of Participants With Total ALP Normalization at Week 12|The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
1225567|NCT00699751|Secondary|Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
1225568|NCT00699751|Secondary|Percentage of Participants With Total ALP Response at Week 12|ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either >/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
1225569|NCT00699751|Secondary|Time to Total Alkaline Phosphatase (ALP) Progression|The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later|From randomization to first ALP progression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects.|||Months||95% Confidence Interval|Median
1225570|NCT00699751|Primary|Overall Survival|Overall survival was defined as the time from date of randomization to the date of death.|From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)|The intent-to-treat (ITT) population was defined as all randomized subjects.|||Months||95% Confidence Interval|Median
1225571|NCT00699699|Secondary|Patients' Satisfaction After 6 Weeks of Treatment|"Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment (very satisfied, satisfied, rather satisfied, neither satisfied nor unsatisfied, rather unsatisfied, unsatisfied, and very unsatisfied)"|6 weeks|There were 1260 patients who had evaluable PGE after 6 weeks|||Participants|||Number
1225572|NCT00699699|Secondary|Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety|"Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications poor (1, 2), satisfactory (3, 4), good (5, 6), and excellent (7, 8))"|Baseline and after 6 weeks of treatment|There were 1260 patients who had evaluable PGE at both baseline and after 6 weeks|||PGE scale points||Standard Deviation|Mean
1225573|NCT00699699|Secondary|Change From Baseline in the PF-10 Score After 6 Weeks|Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)|Baseline and after 6 weeks of treatment|There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks|||PF-10 score points||Standard Deviation|Mean
1225575|NCT00699660|Secondary|Resource Utilization|time spent administering the exam|same day||||minutes||Standard Deviation|Mean
1225579|NCT00699608|Secondary|Coordination Score, as Assessed by the Linear Analogue Rating Scales|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Dizziness and Clumsiness scores are averaged to derive an overall “Coordination” score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||points on a scale||Standard Error|Least Squares Mean
1225580|NCT00699608|Secondary|Mood Score, as Assessed by the Linear Analogue Rating Scales|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Anxiety, Depression, Relaxed, and Sadness scores are averaged to derive an overall “Mood” score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||points on a scale||Standard Error|Least Squares Mean
1225581|NCT00699608|Secondary|Sedation Score, as Assessed by the Linear Analogue Rating Scales|The Linear Analogue Rating Scale (LARS) is used as a measure of the subjective effects of psychoactive drugs. Participants mark a series of 10 cm (100 unit line) analogue scales (1-100, 100 = most impaired) relating to dizzy, clumsy, anxious, relaxed, tired, drowsy, alert, energetic, sad, and depressed, indicating their present feeling with regard to a mid-point, representing their “usual” state of mind before treatment began. The higher the score, the more impaired the participant feels. The Tiredness, Alertness, Energy, and Drowsiness scores are averaged to derive an overall Sedation score.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||points on a scale||Standard Error|Least Squares Mean
1225582|NCT00699608|Secondary|3-Back Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||milliseconds||Standard Error|Least Squares Mean
1225583|NCT00699608|Secondary|1-Back Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||milliseconds||Standard Error|Least Squares Mean
1225584|NCT00699608|Secondary|3-Back Percentage of Correct Responses|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). In “3-back” tasks, a comparison is made between the current stimulus and the two before the immediately preceding stimulus. In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of “match” trials to non-match trials. The duration of the test is 2 min. The percentage of correct responses is the percentage of correct responses given in 2 min.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||percentage of responses||Standard Error|Least Squares Mean
1225585|NCT00699608|Secondary|1-Back Percentage of Correct Responses|The N-Back task requires the participant to indicate, using the mouse, whether the current stimulus presented on the screen and the one immediately before it visually match (i.e., “one-back”). In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of “match” trials to non-match trials. The duration of the test is 2 minutes. The percentage of correct responses is the percentage of correct responses given in 2 minutes.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||percentage of responses||Standard Error|Least Squares Mean
1225586|NCT00699608|Secondary|Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||number of substitutions||Standard Error|Least Squares Mean
1225612|NCT00699400|Secondary|Implantation Rate|Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles|At time of ultrasound after embryo transfer||||Implantation Rate (%)|Participants|Standard Deviation|Mean
1225613|NCT00699400|Secondary|Oocyte Survival Rate|Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle|At time of fertilization||||Oocyte survival rate (%)|Participants|Standard Deviation|Mean
1225587|NCT00699608|Secondary|Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||number of substitutions||Standard Error|Least Squares Mean
1225588|NCT00699608|Secondary|Critical Flicker Fusion Test–Overall Threshold|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four ascending and four descending presentations of the CFF give the overall threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||hertz||Standard Error|Least Squares Mean
1225589|NCT00699608|Secondary|Critical Flicker Fusion Test –Descending Threshold|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four descending presentations from the CFF give the descending threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||hertz||Standard Error|Least Squares Mean
1225590|NCT00699608|Secondary|Critical Flicker Fusion Test–Ascending Threshold|Critical Flicker Fusion (CFF) is a validated cognitive assessment task that provides an index of central nervous system (CNS) activity and attention modulated motion detection. Participants are required to discriminate flicker from fusion, and vice versa, in a set of four light-emitting diodes arranged in a one-centimetre square. These diodes are held in foveal fixation when viewed at a distance of one metre. Individual thresholds are determined on four ascending and four descending scales. The mean of the four ascending presentations give the ascending threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||hertz||Standard Error|Least Squares Mean
1225591|NCT00699608|Secondary|CTT Mean Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) A further outcome derived from the CTT is a peripheral awareness task where the participant responds to a stimulus presented in the periphery of vision, while simultaneously attending to the tracking test. The mean reaction time, in milliseconds, to these stimuli over the trial period is taken as the response measure for this component of the divided attention task. A lower mean reaction time is indicative of better peripheral awareness.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||milliseconds||Standard Error|Least Squares Mean
1225592|NCT00699608|Secondary|Mean Tracking Error (MTE) Assessed During the CTT|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) . The CTT is a task (8 minute duration) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the MTE, the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||pixels||Standard Error|Least Squares Mean
1225593|NCT00699608|Primary|Mean Tracking Error Assessed During the Continuous Tracking Test (CTT)|Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.|7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all subjects who gave informed consent, were randomised, and received at least one dose of double-blind medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||pixels||Standard Error|Least Squares Mean
1225594|NCT00699582|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set with Complex Partial plus Secondarily Generalized Seizures at Pre-randomization. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.|||Percent Change||Full Range|Median
1225614|NCT00699400|Secondary|Number of Oocytes Thawed||At start of thawing cycle||||Number of oocytes thawed|Participants||Number
1225615|NCT00699400|Secondary|Number of Oocytes Frozen||At cryopreservation||||Number of Oocytes Frozen|Participants||Number
1225595|NCT00699582|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.|||Percentage of Participants|||Number
1225596|NCT00699582|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Doubleblind Phase. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.|||Percent Change||Full Range|Median
1225597|NCT00699556|Secondary|Craving for Alcohol|Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ). The range of scores is 1-100 on a visual analog scale (VAS). Higher scores indicate higher levels of craving. Score indicated is the total score.|first measurement during laboratory session (+60 minutes after beginning of laboratory session)||||units on a scale||Standard Error|Mean
1225598|NCT00699556|Primary|Number of Drinks Consumed During an Ad-libitum Drinking Period|Participants are presented with alcohol beverages and allowed to drink at their leisure.|Two hour ad-libitum drinking period during laboratory session||||drinks||Standard Deviation|Mean
1225599|NCT00699491|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.|||months||95% Confidence Interval|Median
1225600|NCT00699491|Secondary|Progression Free Survival Rate|Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method.|At 6 months|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.|||percentage of patients||95% Confidence Interval|Number
1225601|NCT00699491|Secondary|Progression Free Survival (PFS) (Phase II)|Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method.|Time from registration to documentation of disease progression, up to 5 years|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.|||months||95% Confidence Interval|Median
1225602|NCT00699491|Secondary|Duration of Response (Phase II)|Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method.|Up to 5 years|No patients were eligible for this endpoint.||||||
1225603|NCT00699491|Secondary|Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II)|Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be ‘at least possibly related to treatment’ will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported.|Up to 5 years|All patients that received protocol treatment were evaluable for this endpoint.|||participants|||Number
1225604|NCT00699491|Primary|Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)|"A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart.~Complete Response (CR): All of the following must be true:~Disappearance of all target and non-target lesions.~Each target lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures.~The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach."|Up to 5 years|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.|||percentage of patients with response||90% Confidence Interval|Number
1225605|NCT00699491|Primary|Recommended Dose Level for Phase II Testing (RPTD) (Phase I)|"The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.~Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:~Any grade 4 hematologic toxicity~Hyperglycemia that cannot be stably controlled with diabetic medication~Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)"|During first course|Patients registered to the Phase I portion of the protocol were analyzed for this endpoint. One patient in Dose Level -1, one patient in Dose Level -2, and two patients in Dose Level -2B discontinued study treatment during Cycle 1 for reasons unrelated to toxicity and were excluded from this endpoint.|||DLTs|||Number
1225606|NCT00699413|Secondary|Hunger||Measured at baseline and 12 weeks|||||||
1225618|NCT00699400|Primary|Thawing Cycle Level Live Birth Rate|Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.|Birth of one or more live babies|Live birth rate per thaw cycle(%)|||% of oocytes thawed per cycle|Participants|95% Confidence Interval|Mean
1225619|NCT00699374|Secondary|European Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state."|Day 1 of each cycle|Data were not collected per Amendment 2 to the protocol removing collection for this endpoint.||||||
1225620|NCT00699374|Secondary|Time to Tumor Progression (TTP)|Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population|||Weeks|Participants|95% Confidence Interval|Median
1225621|NCT00699374|Secondary|Progression-Free Survival (PFS)|The period from randomization until disease progression or death.|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population|||Weeks|Participants|95% Confidence Interval|Median
1225622|NCT00699374|Primary|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population, all randomized participants where participants were classifed according to the randomized treatment arm regardless of what treatment, if any, was received.|||Weeks|Participants|95% Confidence Interval|Median
1225623|NCT00699348|Secondary|Number of Participants With Red Blood Cell Transfusion During the Study|Number of participant who underwent red blood cell transfusion during the study was reported.|Week -4 up to Week 52|Safety population.|||participants|||Number
1225624|NCT00699348|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 up to Week 16 and Week 17 up to Week 24|PP population.|||percentage of participants|||Number
1225625|NCT00699348|Secondary|Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|PP population.|||days||Full Range|Median
1225626|NCT00699348|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range|Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|PP population.|||percentage of participants||95% Confidence Interval|Number
1225627|NCT00699348|Secondary|Change in Hemoglobin Concentration Between Reference SVP and EEP|The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.|Week -4 up to Week 0 and Week 17 up to Week 24|PP Population.|||g/dL||Standard Deviation|Mean
1225628|NCT00699348|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range|Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|Per protocol (PP) population included all participants who received at least 1 dose of C.E.R.A. and for whom data for at least 1 follow-up variable was available with the exception of participants who did not fulfill the protocol specified inclusion criteria for this analysis set.|||percentage of participants||95% Confidence Interval|Number
1225629|NCT00699335|Secondary|Physician's Final Assessment of the Tolerability of Matrifen®|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
1225630|NCT00699335|Secondary|Physician's Assessment of the Adhesion Properties of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
1225631|NCT00699335|Primary|EQ-5D (Optional): Visual Analogue Scale|Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1225632|NCT00699335|Primary|EQ-5D (Optional): European Index Score|Index derived from the five EQ-5D-items (= mobility, self care, usual activities, pain/discomfort, anxiety/depression) resulting in a value from -1= very ill to 1=full health|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1225633|NCT00699335|Primary|EQ-5D (Optional): Domain Anxiety / Depression|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I am not anxious or depressed~I am moderately anxious or depressed~I am extremely anxious or depressed"|Before and after therapy with Matrifen® (4 weeks)||||Units on a scale||Standard Deviation|Mean
1227299|NCT00685295|Primary|Time to Analgesia|Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)|60 minutes||||minutes||Inter-Quartile Range|Median
1225634|NCT00699335|Primary|EQ-5D (Optional): Domain Anxiety / Depression|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I am not anxious or depressed~I am moderately anxious or depressed~I am extremely anxious or depressed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
1225635|NCT00699335|Secondary|Patient's Assessment of the Acceptance of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
1225636|NCT00699335|Secondary|Physician's Assessment of the Skin Tolerability of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
1225637|NCT00699335|Primary|EQ-5D (Optional): Pain / Discomfort|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no pain or discomfort~I have moderate pain or discomfort~I have extreme pain or discomfort"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1225638|NCT00699335|Primary|EQ-5D (Optional): Pain / Discomfort|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no pain or discomfort~I have moderate pain or discomfort~I have extreme pain or discomfort"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
1225639|NCT00699335|Primary|EQ-5D (Optional): Domain Usual Activities|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with performing my usual activities~I have some problems with performing my usual activities~I am unable to perform my usual activities"|Before and after therapy with Matrifen® (4 weeks)||||Units on a scale||Standard Deviation|Mean
1225640|NCT00699335|Primary|EQ-5D (Optional): Domain Usual Activities|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with performing my usual activities~I have some problems with performing my usual activities~I am unable to perform my usual activities"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
1225641|NCT00699335|Primary|EQ-5D (Optional): Domain Self Care|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with self-care~I have some problems washing or dressing myself~I am unable to wash or dress myself"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1225642|NCT00699335|Primary|EQ-5D (Optional): Domain Self Care|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with self-care~I have some problems washing or dressing myself~I am unable to wash or dress myself"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
1225643|NCT00699335|Primary|EQ-5D (Optional): Domain Mobility|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems in walking around~I have some problems in walking around~I am confined to bed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1225644|NCT00699335|Primary|EQ-5D (Optional): Domain Mobility|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems in walking around~I have some problems in walking around~I am confined to bed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
1225645|NCT00699335|Primary|Physician's Final Assessment of the Efficacy of Therapy With Matrifen®|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
1225646|NCT00699335|Primary|Patient's Assessment of Pain Severity Score|Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1225647|NCT00699283|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase|The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.|From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)|"The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs.~The Outcome Measure was only pre-specified for the Brivaracetam (BRV) 50 mg Arm"|||percentage of subjects||95% Confidence Interval|Number
1225649|NCT00699218|Primary|Hamilton Rating Scale for Depression (HAM-D)|Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.|5 weeks||||units on a scale||Standard Deviation|Mean
1225650|NCT00699192|Secondary|Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)|Overall blood pressure control was defined as a msSBP < 140 mmHg and msDBP < 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|End of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.|||Percentage of patients|||Number
1225651|NCT00699192|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)|Systolic blood pressure control was defined as a msSBP < 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|End of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.|||Percentage of patients|||Number
1225652|NCT00699192|Secondary|Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8|A systolic blood pressure response was defined as a msSBP < 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.|||Percentage of patients|||Number
1225653|NCT00699192|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.|||mmHg||Standard Deviation|Mean
1225654|NCT00699192|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the Week 8 assessments, an LOCF (last observation carried forward) approach was used.|||mmHg||Standard Deviation|Mean
1225655|NCT00699153|Secondary|Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative Day 3-18 (Each follow-up Visit 4-7)|Intent to treat population.|||Composite scores||Standard Deviation|Mean
1225656|NCT00699153|Secondary|Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|At each visit: Visit 4-7, postoperative days 3-18|Intent to treat population|||participants|||Number
1225657|NCT00699153|Primary|Participants With Grade 0 (no) Pain|Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe|Postoperative day 8 (Visit 5)|Intent to treat population|||participants|||Number
1225658|NCT00699153|Primary|Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative day 8 (Visit 5)|Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no.|||participants|||Number
1225723|NCT00698035|Secondary|Total Testosterone Levels|By serum ultrasensitive total testosterone test (Quest Diagnostics)|12 weeks|Per protocol, participants assigned to the Testosterone arm who completed 12 weeks of assigned treatment and had testosterone measurement at baseline, 4 weeks and 12 weeks.|||ng/dl||Standard Deviation|Mean
1225659|NCT00699140|Secondary|Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA|The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|Intent-to-treat population|||seroconversions|||Number
1225660|NCT00699140|Secondary|Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels)|Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator’s judgment) was listed.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|Intent-to-treat population|||participants|||Number
1225661|NCT00699140|Secondary|Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions|All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|ITT population: patient who received at least one infusion with the study drug.|||percentage of infusions|||Number
1225662|NCT00699140|Secondary|Frequency of Adverse Reactions During and After Infusions by Percentage of Patients|All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|ITT population: patient who received one infusion with the study drug.|||percentage of patients|||Number
1225663|NCT00699140|Secondary|Regression of Hemorrhages.|"Percentage of subjects with regression of hemorrhages of Types 1 to 3:~Type 0: Patients without symptoms of bleeding at the first infusion continue without presenting spontaneous bleeding~Type 1: Patients with bleeding symptoms at the first infusion had a reduction of the size of large ecchymoses, and no spontaneous appearance of new ecchymoses~Type 2: Patients with bleeding symptoms at the first infusion had a decrease in the number of cutaneous petechiae, or the extent of the affected area of the body decreased~Type 3: Patients had active mucosal bleedings at the first infusion, these episodes stopped without re-bleeding, and there was no occurrence of new spontaneous mucosal hemorrhages (e.g., gingival bleeding, epistaxis)"|First 10 to14 days since the first infusion day (Day 1)|ITT population: patients who received at least one infusion of the study drug|||percentage of subjects||95% Confidence Interval|Number
1225664|NCT00699140|Secondary|Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)|Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1)|At any time during the study period (up to 3 months [90 days])|From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population only 13 responded to the treatment|||days||Full Range|Median
1225665|NCT00699140|Secondary|Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)|The time taken for the platelet count to reach ≥ 50x10^9/L from first dose|At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])|From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population but only 13 responded to the treatment|||days||Full Range|Median
1225666|NCT00699140|Secondary|Maximum Platelet Level Reached During the Follow-up Period|Platelet count was measured at various time points in the follow-up period after infusion.|During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])|The maximum platelet counts were taken from the population who responded to treatment (platelet count ≥ 50x10^9/L). If any patient received banned medication due to ITP progression during the study, the values obtained after patients received treatment were excluded.|||platelets x 10^-9/L||Full Range|Median
1225667|NCT00699140|Primary|Responder Patients|The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L.|At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).|All 18 subjects received at least one infusion (at any dose) of IGIV3I Grifols and were included in the intent-to-treat (ITT) population for efficacy and safety analysis.|||percentage of subjects||95% Confidence Interval|Number
1225668|NCT00699010|Primary|Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)|"“Do you dislike or like the drug effect you are feeling now?” This question was rated on a 1 to 29 point VAS scale that was anchored in the center with “neither like nor dislike” (14), on the left with “dislike an awful lot” (1), and on the right with “like an awful lot (29)."|Effects assessed at 0.5 hours after dosing.|Study completers and per protocol|||score on a scale||Standard Error|Mean
1225669|NCT00698932|Secondary|Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24|Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||Percentage of Participants|||Number
1225691|NCT00698815|Secondary|Overall Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Duration of treatment (up to 3 years)||||percentage of participants||95% Confidence Interval|Number
1225670|NCT00698932|Secondary|Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.|||mg*min/dL||Standard Error|Mean
1225671|NCT00698932|Secondary|Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.|||mmol*min/L||Standard Error|Mean
1225672|NCT00698932|Secondary|Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
1225673|NCT00698932|Secondary|Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||mmol/L||Standard Error|Mean
1225674|NCT00698932|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||percent||Standard Error|Mean
1225675|NCT00698867|Secondary|Incidence of Surviving Elbows|Proportion of elbows that did not require revision or removal|Up to 5 Years|Subjects with complete 5 year data.|||Proportion of Elbows|Elbows|95% Confidence Interval|Number
1225676|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength|Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.|5 Years||||Scores on a scale|Elbows|Standard Deviation|Mean
1225677|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability|Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.|5 Years||||Scores on a scale|Elbows|Standard Deviation|Mean
1225678|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs|This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.|5 Years||||Scores on a scale|Elbows|Standard Deviation|Mean
1225679|NCT00698867|Primary|Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction|This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.|5 Years||||Scores on a scale|Elbows|Standard Deviation|Mean
1225680|NCT00698867|Primary|Patient Derived American Shoulder and Elbow Society Score (ASES) Function|This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.|5 Years|Discovery elbows|||Scores on a scale|Elbows|Standard Deviation|Mean
1225681|NCT00698867|Primary|American Shoulder and Elbow Society Score (ASES) Pain Assessment|This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.|5 years|Discovery Elbow|||Scores on a scale|Elbows|Standard Deviation|Mean
1225692|NCT00698815|Secondary|PFS|PFS was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.|Time from randomization to disease progression and death of any cause, whichever comes first (up to 3 years)||||months||95% Confidence Interval|Median
1225760|NCT00697593|Primary|Biochemistry - Potassium|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||mmol/L||Standard Deviation|Mean
1225682|NCT00698841|Secondary|Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study|BL=baseline; OS=on-study; LLN=lower level of normal. Laboratory values assessed using CTC for AEs, Version 3.0. Hemoglobin (g/dL) Grade 1:<LLN to 10.0, Grade 2:<10.0 to 8.0, Grade 3:<8.0 to 6.5, Grade 4:<6.5. Platelets Grade 1:LLN to 75.0*10^9/L, Grade 2:<75.0 to 50.0*10^9/L, Grade 3:<50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L. White blood cells Grade 1:<LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3:<2.0 to 1.0*10^9/L, Grade 4:<1.0*10^9/L. Neutrophils Grade 1:<LLN to 1.5*10^9/L, Grade 2:<1.5 to 1.0*10^9/L, Grade 3:<1.0 to 0.5*10^9/L, Grade 4:<0.5*10^9/L.|At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up|All participants who received at least 1 dose of cetuximab.|||Participants|||Number
1225683|NCT00698841|Primary|Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia’s Correction Formula (QTcF) by Study Day and Time Point|The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The QTc is the QT interval corrected for heart rate. The QTcF=QT/RR^1/3, where RR=RR interval in seconds. Baseline=predose. Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline.|Predose Day 1 (Baseline) to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.|||msec||Standard Error|Mean
1225684|NCT00698841|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)|BL=baseline; OS=on-study; LLN=lower level of normal; ULN=upper level of normal. Sodium, low(mmol/L) Grades 1&2:<LLN–130, Grade 3:<130–120, Grade 4:<120. Sodium, high (mmol/L) Grade 1:>ULN-150, Grade 2:>150-155, Grade 3:>155-160, Grade 4:>160. Potassium, high (mmol/L) Grade 1:>ULN-5.5, Grade 2:>5.5-6.0, Grade 3:>6.0-7.0, Grade 4:>7.0. Glucose, low(mg/dL) Grade 1:<LLN-55, Grade 2:<55-40, Grade 3:<40-30, Grade 4:<30. Glucose, high (mg/dL) Grade 1:>ULN-160, Grade 2:>160-250, Grade 3:>250-500, Grade 4:>500. Calcium, high(mg/dL) Grade 1:>ULN-11.5, Grade 2:>11.5-12.5, Grade 3:>12.5-13.5, Grade 4:>13.|At screening, at the end of Cycle 1 (28 days)|All participants who received at least 1 dose of cetuximab|||Participants|||Number
1225685|NCT00698841|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study|BL=baseline; OS=on-study; ULN=upper level of normal. Albumin,low (g/dL) Grade 1:<LLN-30, Grade 2:<30-20, Grades 3&4:<20. Aspartate aminotransferase (AST)(U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Total bilirubin, high Grade 1:ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-10.0*ULN, Grade 4:>10.0*ULN. Alkaline phosphatase (ALP) (U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Creatinine (mg/dL) Grade 1:>ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-6.0*ULN, Grade 4:>6.0*ULN.|At screening, at the end of Cycle 1 (28 days)|All participants who received at least 1 dose of cetuximab|||Participants|||Number
1225686|NCT00698841|Secondary|Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs of special interest have been sponsor-selected based on the known clinical effects of cetuximab. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. CTC Grade 1: Mild. Grade 2: Moderate. Grade 3: Severe or medically significant but not immediately life-threatening. Grade 4: Life-threatening.|Baseline through Cycle 1 (28 days), continuously||||Participants|||Number
1225687|NCT00698841|Secondary|Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment.|Baseline through Cycle 1 (28 days), continuously|All participants who received at least 1 dose of cetuximab.|||Participants|||Number
1225688|NCT00698841|Secondary|Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate|12-Lead continuous digital ECG data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The PR interval is the time from the onset of the P wave to the beginning of the QRS complex. The QRS interval=deflections in the ECG, comprising Q, R, and S waves, that represent depolarization of the ventricles. Clinically significant was determined at the investigator's discretion.|Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.|||Participants|||Number
1225689|NCT00698841|Primary|Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline|12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.|Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.|||Participants|||Number
1225690|NCT00698815|Secondary|Overall Survival (OS)|OS is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 3 years)||||months||95% Confidence Interval|Median
1225693|NCT00698815|Primary|18 Week Progression-free Survival (PFS) Rate|The 18 week progression-free survival rate was defined as the proportion of patients that were alive and progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.|At 18 weeks||||percentage of participants||95% Confidence Interval|Number
1225694|NCT00698685|Primary|Non-relapse Mortality at or Before Day 100|The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin’s disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).|Day 100 after transplant|All participants who received at least 1 day of treatment.|||Participants|||Number
1225695|NCT00698685|Primary|Actuarial Probability of Donor Hematopoietic Engraftment (Defined as at Least 50% Donor DNA in Bone Marrow at Day 100).|The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.|Day 100 after transplant.|All participants who completed treatment and underwent allogeneic transplant.|||participants|||Number
1225696|NCT00698646|Secondary|Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])||During 16 weeks|Intent to treat (ITT)|||Weeks||95% Confidence Interval|Median
1225697|NCT00698646|Secondary|Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)|Cumulative refers to achieving blood pressure goal before or at the corresponding visit.|Weeks 4, 8, 12 and 16|Intent to treat (ITT)|||Percentage of Participants|||Number
1225698|NCT00698646|Secondary|Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg|Cumulative refers to achieving of blood pressure control before or at the corresponding visit.|Weeks 4, 8, 12 and 16|Intent to treat (ITT)|||Percentage of Participants|||Number
1225699|NCT00698646|Secondary|Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Weeks 8, 12, and 16|Intent to treat (ITT), Last observation carried forward|||mm Hg||Standard Deviation|Mean
1225700|NCT00698646|Secondary|Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Weeks 4, 8, 12 and 16|Intent to treat (ITT), Last observation carried forward|||mm Hg||Standard Deviation|Mean
1225701|NCT00698646|Primary|Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward|||mm Hg||Standard Deviation|Mean
1225702|NCT00698581|Secondary|The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.|||Participants|||Number
1225703|NCT00698581|Secondary|The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.|||Participants|||Number
1225704|NCT00698581|Secondary|The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.|||Participants|||Number
1225705|NCT00698581|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase|The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.|From Week 1 up to Week 17|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.|||proportion of subjects||95% Confidence Interval|Number
1225706|NCT00698516|Secondary|Overall Survival|Overall survival is defined as the time from initiation of investigational product to death due to any cause. For participants who did not die, the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population|||weeks||95% Confidence Interval|Median
1225707|NCT00698516|Secondary|Time to Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Time to response is defined as the time from initiation of investigational product to the time of first documented response (CR or PR).|Baseline to disease progression or death (up to 82.4 weeks)|Participants from the ITT Population who had CR and PR|||weeks||95% Confidence Interval|Median
1225708|NCT00698516|Secondary|Duration of Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Duration of response is defined as the time from start of response (CR or PR) until progression or death due to any cause. For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|Participants from the ITT Population who had CR and PR|||weeks||95% Confidence Interval|Median
1225709|NCT00698516|Secondary|Number of Participants With a Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population|||participants|||Number
1225761|NCT00697593|Primary|Biochemistry - Sodium|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||mmol/L||Standard Deviation|Mean
1225710|NCT00698516|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|Tumor response was determined using the RECIST guidelines.CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since treatment started; PD, >=20% increase in sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population|||participants|||Number
1225711|NCT00698516|Secondary|PFS - Overall|Progression-free survival at any site was defined as the time from initiation of investigational product to the time of first documented disease progression or death due to any cause. Progression was assessed using the RECIST guidelines: >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion (s). For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population|||weeks||95% Confidence Interval|Median
1225712|NCT00698516|Primary|Percentage of Participants With Progression-free Survival (PFS) at 3 Months|PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): >=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.|3 months|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication|||percentageof participants|||Number
1225713|NCT00698451|Secondary|The Secondary Efficacy Endpoints is Duration of Objective Response.|Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.|Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.|ITT|||Days||Full Range|Median
1225714|NCT00698451|Primary|The Primary Efficacy End Point is the Number of Patients With an Objective Response.|Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)|ITT|||Participants|||Number
1225715|NCT00698204|Secondary|Evaluation of Pain Severity at 5000 cGy Radiation|Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable|5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)|Only subjects who were still taking the study drug (celecoxib or placebo) when cumulative radiation dose of 5000 cGy was reached are included in this analysis (19 of 20 in each group were analyzed).|||units on a scale||Standard Deviation|Mean
1225716|NCT00698204|Primary|Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy|"Oral Mucositis Assessment Scale (OMAS) was used to assess oral mucosal injury during the period of radiation therapy. This validated scale scores ulceration and erythema independently at nine specified sites in the oral cavity. Ulceration is scored from 0-3 based on size of lesion and erythema is scored from 0-2 based on severity of erythema. The sum of scores is then divided by 9.~The mean OMAS score at a cumulative radiation dose of 5000 cGy (approximately 5 weeks of treatment) was compared between groups."|5 weeks from start of radiation therapy (5000 cGy)|Subjects participating in the study as they reached a cumulative dose of 5000 cGy were included. One subject in the celecoxib group withdrew prior to reaching 5000 cGy.|||units on a scale||Standard Deviation|Mean
1225717|NCT00698139|Secondary|Changes in B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) was measured for all subjects to determint the difference between pre- and post-procedure.|baseline and 6 hours||||ng/L||Standard Deviation|Mean
1225718|NCT00698139|Secondary|Changes in Thoracic Impedence|Impedence will be measured using the pacemaker programmer to determine the difference in thoracic impedence pre- and post-procedure.|baseline and 6 hours||||ohm||Standard Deviation|Mean
1225719|NCT00698139|Primary|Change in Cardiac Output (CO)|The difference between post and pre CO|baseline and 6 hours||||L/min||Standard Deviation|Mean
1225720|NCT00698035|Secondary|Change in Vaginal Epithelium Scores|During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.|Baseline, 12 weeks|Patients with both baseline and week 12 gynecologic exams for evaluation of vaginal atrophy|||units on a scale||Standard Deviation|Mean
1225721|NCT00698035|Secondary|Sexual Satisfaction|"Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked Overall, how satisfactory to you is your sexual relationship with your partner? Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory)."|Baseline, Week 4, Week 12|Participants who provided responses to SD, SI and SS at all 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)|||units on a scale||Standard Deviation|Mean
1225722|NCT00698035|Secondary|Sexual Quality of Life|Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.|Baseline, Week 4, Week 12|Participants who provided responses to SD, SI and SS at 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)|||units on a scale||Standard Deviation|Mean
1225762|NCT00697593|Primary|Hematology - Platelet Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 4 participants missing values|||x10^9/L||Standard Deviation|Mean
1225724|NCT00698035|Primary|Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range|Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.|12 Weeks|Per protocol, to be considered evaluable for the Primary Outcome, patients must complete both baseline evaluation and week 4 safety blood draw. 1 participant in the Testosterone arm was not evaluable.|||participants|||Number
1225725|NCT00698035|Secondary|Matched E2 by Commercial and Research (RIA) Analyses|Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women|baseline, 4 weeks|Patients from both study arms arms with matched pairs of baseline and week 4 E2 performed by both commercial and research labs|||pg/ml||Standard Deviation|Mean
1225726|NCT00698035|Secondary|Serum Estradiol (E2)|serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)|12 weeks|Per protocol, participants who completed 12 weeks of assigned treatment|||pg/ml||Standard Deviation|Mean
1225727|NCT00698022|Secondary|The Safety Objective is to Evaluate the Safety and Tolerability of Mifepristone in Combination With Risperidone in Healthy Male Volunteers.||28 days|||||||
1225728|NCT00698022|Secondary|The Secondary Study Objectives Are to Determine the Mean Percent Change in Baseline Body Weight; and the Proportion of Subjects That Gain Less Than 5% and Less Than 7% of Their Baseline Body Weight in the Treatment Groups.||28 days|||||||
1225729|NCT00698022|Primary|Change in Weight (kg) From Baseline to Day 28.|Change in weight (kg) was compared at Baseline and Day 28 for all subjects in all treatment arms.|baseline and 28 days||||kilograms||Standard Error|Mean
1225730|NCT00698009|Primary|Number of Participants Infused Haploidentical Donor-derived Natural Killer (NK) Cells and Low-dose Interleukin-2 (IL-2)|Feasibility of an infused allogeneic donor NK cell product and IL-2 following a cyclophosphamide and fludarabine preparative regimen to treat relapsed neuroblastoma after autologous peripheral blood stem cell (PBSC) transplant where feasibility is defined as being able to infuse NK cells on day 0.|21 days, up to 1 year|||||||
1225731|NCT00698009|Primary|Participant Disease Response|Neuroblastoma International Response Criteria: Complete Response (CR): No evidence of disease (primary and metastasis) clinically & radiographic studies, (homovanillic acid (HVA)/vanillylmandelic acid (VMA) normal). Very Good Partial Response (VGPR): >90% reduction in primary tumor, resolution all metastatic tumor except bone. No new bone lesions and improvement on scan of all pre-existing lesions; HVA/VMA decreased >90%. Partial Response (PR): 50-90% reduction primary and all measurable metastatic lesions, 0-1 bone marrow samples with tumor; scans of bone lesions same as VGPR. HVA/VMA decreased 50-90%. Mixed Response (MR): > 50% reduction any measurable disease (primary or metastases); no new lesions; <25% increase in any existing lesion (exclude bone marrow evaluation). No Response (NR): No new lesions; < 25% increase in existing lesion. Progressive Disease (PD): Any new lesions. Increase <25% in measurable lesion, previous negative bone marrow positive for tumor.|1 Year for overall patient response, or until disease progression|||||||
1225732|NCT00697827|Secondary|Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. There are 10 questions. The questions are designed in a way to show how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. For this study,any improvement at 24 months compared to pre-operative baseline was determined as a success.|24 months||||participants|||Number
1225733|NCT00697827|Primary|Zurich Claudication Questionnaire(ZCQ)|The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of < 2.5 points for patient satisfaction at 24 months.|24 months||||participants|||Number
1225734|NCT00697801|Secondary|Change From Baseline in FEV1% Predicted|The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer. An increase indicates an improvement (a greater volume of air expired).|baseline, week 6|Patients with available data at specified time points are included in the analysis population.|||percentage of predicted FEV1||Standard Deviation|Mean
1225735|NCT00697801|Primary|Change From Baseline in Nighttime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 6|Patients with available data at specified time points are included in the analysis population.|||units on a scale||Standard Deviation|Mean
1225763|NCT00697593|Primary|Hematology - Lymphocytes|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
1225764|NCT00697593|Primary|Hematology - Monocytes|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
1225765|NCT00697593|Primary|Hematology - Basophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
1225736|NCT00697801|Primary|Change From Baseline in Daytime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 6|Patients with available data at specified time points are included in the analysis population.|||units on a scale||Standard Deviation|Mean
1225737|NCT00697788|Secondary|Heart Rate|Heart Rate recorded off EKG in beats per minute|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration||||heart beats per minute||Standard Deviation|Mean
1225738|NCT00697788|Secondary|Oxygen Saturation|Pulse oximetry was used to measure oxygen saturation.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration||||Percent of Hemoglobin Saturated||Standard Deviation|Mean
1225739|NCT00697788|Secondary|Presence of Arrhythmias.|Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration|EKG was analyzed on each participant looking for presence of arrhythmias. None were detected.|||Participants|||Count of Participants
1225740|NCT00697788|Primary|Percent Change in Mean Arterial Pressure (MAP)|Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration|Acutely burned pediatric patients intubated with burns >=20% between 2 and 19 years of age requiring escalating doses of morphine and midazolam|||% change||Standard Deviation|Mean
1225741|NCT00697697|Primary|Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination|A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.|40 weeks|All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.|||participants|||Number
1225742|NCT00697697|Primary|Number of Patients With Treatment Emergent Adverse Events Related to Study Drug|A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.|40 weeks|All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.|||participants|||Number
1225743|NCT00697619|Primary|Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .||Baseline, the first, second and third month||||nM /mM||Standard Error|Median
1225744|NCT00697593|Primary|Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis|Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above|Week 12 / Early Termination|||||||
1225745|NCT00697593|Primary|Urinalysis - Leukocytes Esterase|Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values|||participants|||Number
1225746|NCT00697593|Primary|Urinalysis - Nitrite|Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values|||participants|||Number
1225747|NCT00697593|Primary|Urinalysis - Blood|Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values|||participants|||Number
1225748|NCT00697593|Primary|Urinalysis - Glucose|Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values|||participants|||Number
1225749|NCT00697593|Primary|Urinalysis - Ketones|Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine|Week 12 / Early Termination||||participants|||Number
1225750|NCT00697593|Primary|Urinalysis - Protein|Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine|Week 12 / Early Termination||||participants|||Number
1225751|NCT00697593|Primary|Urinalysis - pH|Urine samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||pH units||Standard Deviation|Mean
1225752|NCT00697593|Primary|Biochemistry - C-Reactive Protein (CRP)|Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L|Week 12 / Early Termination|Safety Population - 1 participant with missing values|||participants|||Number
1225753|NCT00697593|Primary|Biochemistry - Urea|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||mmol/L||Standard Deviation|Mean
1225754|NCT00697593|Primary|Biochemistry - Glutamyl Transferase|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||IU/L||Standard Deviation|Mean
1225755|NCT00697593|Primary|Biochemistry - Alkaline Phosphatase|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||IU/L||Standard Deviation|Mean
1225756|NCT00697593|Primary|Biochemistry - Alanine Transaminase (ALT)|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||IU/L||Standard Deviation|Mean
1225757|NCT00697593|Primary|Biochemistry - Aspartate Transaminase (AST)|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 2 participants missing values|||IU/L||Standard Deviation|Mean
1225758|NCT00697593|Primary|Biochemistry - Total Bilirubin|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||μmol/L||Standard Deviation|Mean
1225759|NCT00697593|Primary|Biochemistry - Creatinine|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||μmol/L||Standard Deviation|Mean
1225771|NCT00697593|Secondary|Static Physician’s Global Assessment (sPGA)|Number of subjects who achieve an Static Physician’s Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).|12 Weeks/Early Termination|Safety Population|||participants|||Number
1225772|NCT00697593|Primary|Hematology - Hematocrit|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 4 participants missing values|||packed cell volume||Standard Deviation|Mean
1225773|NCT00697541|Primary|Tmax - Time to Maximum Plasma Concentration|time to maximum plasma concentration|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose||||Hours||Full Range|Mean
1225774|NCT00697541|Primary|AUC - Area Under the Curve of Brimonidine|"Area under the plasma concentration-time curve from 0 hour to the last measurable plasma concentration, calculated by the linear trapezoidal method~After two topical applications of 0.18% COL-118 facial gel, plasma levels of brimonidine for all subjects were below the LoQ (25 pg/mL), with the exception of one single outlier value.~Thus, no PK analysis could be performed for 0.18% COL-118 facial gel.~After ocular administration of 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations of brimonidine were observed in 11 of the 18 subjects who received the brimonidine tartrate ophthalmic solution. Brimonidine rapidly appeared in plasma The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects The mean AUC0-t also was not calculated."|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose||||pg*hr/mL||Full Range|Mean
1225775|NCT00697541|Primary|Cmax - Maximum Systemic Concentration of Brimonidine|Maximum observed plasma concentration|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose||||pg/mL||Full Range|Mean
1225776|NCT00697515|Secondary|Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and 7 days|SP|||msec||Standard Deviation|Mean
1225777|NCT00697515|Secondary|Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|SP|||bpm||Standard Deviation|Mean
1225778|NCT00697515|Secondary|Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|SP|||mmHg||Standard Deviation|Mean
1225779|NCT00697515|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|Safety Population (SP) defined as all subjects who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1225780|NCT00697515|Secondary|Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase|AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree).|Baseline and 26 days||||Units on a scale||Standard Deviation|Mean
1225781|NCT00697515|Secondary|Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase|AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best).|Baseline and 26 days|EEP|||Units on a scale||Standard Deviation|Mean
1225782|NCT00697515|Secondary|Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase|MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.|26 days|EEP|||Participants|||Number
1225783|NCT00697515|Secondary|Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase|The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.|Baseline and 26 days|EEP|||Units on a scale||Standard Deviation|Mean
1225784|NCT00697515|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7 days|ITT|||Participants|||Number
1225785|NCT00697515|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7, 14, 21 and 28 days|EEP|||Participants|||Number
1225786|NCT00697515|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|EEP|||Participants|||Number
1225787|NCT00697515|Secondary|ADHD-RS With Prompts Total Score in the Crossover Phase|The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|7 days|ITT|||Units on a scale||Standard Error|Least Squares Mean
1225788|NCT00697515|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase|The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 7, 14, 21 and 28 days|Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1225789|NCT00697515|Secondary|PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT|||Units on a scale||Standard Error|Least Squares Mean
1225790|NCT00697515|Secondary|PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT|||Units on a scale||Standard Error|Least Squares Mean
1225791|NCT00697515|Secondary|PERMP Total Score by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT|||Units on a scale||Standard Error|Least Squares Mean
1225792|NCT00697515|Primary|Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
1225793|NCT00697463|Primary|Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)|Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.|Baseline, Month 18 or 24 reported|Of 22 women with IOP who enrolled, one withdrew for personal reasons, therefore the overall number of participants analyzed is 21. The percentage of BMD change is calculated for each participant between baseline and Month 24 or between baseline and Month 18, whichever is the longer reported timeframe as some are lost to follow up by Month 24.|||percentage of BMD change||Standard Deviation|Mean
1225794|NCT00697255|Secondary|Number of Participants With AEs of Ovarian Hyperstimulation Syndrome (OHSS)|OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.|During In-Treatment Period (up to 14 weeks after first corifollitropin injection)|The All-Participants-Treated (APT) group consisted of all participants who received corifollitropin alfa. Participants were grouped according to the stage of the trial and the active treatment group (recFSH Stage Ia, hCG Stage Ib) they actually received.|||participants|||Number
1225795|NCT00697255|Secondary|Number of Participants With Pregnancy|A pregnancy test (serum or urinary hCG) was performed two to three weeks after bolus injection of hCG. In case of a positive pregnancy test vaginal and/or abdominal ultrasound scan was performed to confirm the pregnancy at 5 to 6 weeks after bolus injection of hCG and ≥10 weeks after bolus injection of hCG to confirm ongoing pregnancy.|At least 10 weeks after bolus injection of hCG (up to 13 weeks)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||participants|||Number
1225796|NCT00697255|Secondary|Percentage of Participants Who Cancelled Treatment (Cancellation Rate)|Treatment was considered cancelled if no bolus injection of hCG was administrated. Reasons of treatment failure included Adverse Event (AE)/ Serious Adverse Event (SAE), insufficient ovarian response on stimulation day 13 (no follicle ≥12 mm), insufficient ovarian response after 7 days of hCG/recFSH treatment (no follicle ≥18 mm), and multifollicular growth (≥3 follicles ≥15 mm).|Up to 3 weeks after bolus injection of hCG (up to 41 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||percentage of participants|||Number
1225797|NCT00697255|Secondary|Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)|Monofollicular ovulation rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) and confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.|8 days after bolus injection of hCG (up to 28 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||percentage of participants|||Number
1225798|NCT00697255|Secondary|Percentage of Participants With Ovulation (Ovulation Rate)|Ovulation rate was defined as the number of participants with confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.|8 days after bolus injection of hCG (up to 28 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||percentage of participants|||Number
1225799|NCT00697255|Primary|Percentage of Participants With Monofollicular Response (Monofollicular Rate)|The monofollicular rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) divided by the number of the treated participants.|At day of bolus injection of hCG (up to 20 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||percentage of participants|||Number
1225800|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225801|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225802|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225803|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225804|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225805|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225806|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225807|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225808|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225809|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225810|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225811|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225812|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225813|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225814|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
1225815|NCT00697112|Secondary|Percentage of Participants With Clinically-Significant Radiological Abnormalities|Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
1226174|NCT00694551|Secondary|Number of Participants Who Did Not Have PSA Doubling|Number of participants who did not have a PSA doubling before their last study visit, median 458 days from baseline PSA (55-613).|Up to 48 months|29 patients who had serial PSA data, normalized by date and PSA.|||participants|||Number
1225816|NCT00697112|Secondary|Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities|Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats [RR interval]).|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
1225817|NCT00697112|Secondary|Percentage of Participants With Serious Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
1225818|NCT00697112|Secondary|Percentage of Participants With Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
1225819|NCT00697112|Secondary|Percentage of Participants With Physical Abnormalities|Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
1225820|NCT00697112|Secondary|Body Weight||Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||kilogram||Standard Deviation|Mean
1225821|NCT00697112|Secondary|Pulse Rate||Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||beats per minute||Standard Deviation|Mean
1225822|NCT00697112|Secondary|Blood Pressure|Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant’s arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||mmHg||Standard Deviation|Mean
1225823|NCT00697112|Secondary|Number of Participants With Body Temperature|Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever.|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. Results for hypothermia not reported as none of the participants was found hypothermic.|||participants|||Number
1225824|NCT00697112|Secondary|Body Mass Index|BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||kg/m^2||Standard Deviation|Mean
1225825|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported.|Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||percentage of participants|||Number
1225826|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy||Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||percentage of participants|||Number
1225827|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy||Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||percentage of participants|||Number
1226204|NCT00694304|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS|||percentage of patients|||Number
1226205|NCT00694304|Primary|Number of Patients With Adverse Events (AEs)||Baseline to end of the 4-week safety follow-up period|APTS|||participants|||Number
1225828|NCT00697112|Secondary|Average Proteinuria|Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||g/24 hr||Standard Deviation|Mean
1225829|NCT00697112|Secondary|Average Creatinine Clearance|Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||milliliter per minute (mL/min)||Standard Deviation|Mean
1225830|NCT00697112|Secondary|Average Blood Level of Immunosuppressive Drugs Administered|Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1225831|NCT00697112|Secondary|Average Dose of Immunosuppressive Drugs Administered|Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.|||milligram per day||Standard Deviation|Mean
1225832|NCT00697112|Secondary|Probability of Participant Survival|Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||probability of participant survival||95% Confidence Interval|Number
1225833|NCT00697112|Secondary|Probability of no Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than [>] 25 percent [%] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (>25% of parenchyma affected) and severe tubulitis (>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising >25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||probability of no acute rejection||95% Confidence Interval|Number
1225834|NCT00697112|Secondary|Probability of Graft Survival|Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||probability of graft survival||95% Confidence Interval|Number
1225835|NCT00697112|Primary|Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy|The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.|Baseline|Intention-to-Treat (ITT) population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||percentage of participants||95% Confidence Interval|Number
1225836|NCT00697073|Secondary|Nature and Frequency of Adverse Events||12 Months|||||||
1225837|NCT00697073|Secondary|FARS (Friedreich’s Ataxia Rating Scale)||baseline and 12 Months|||||||
1225838|NCT00697073|Primary|Change in ICARS|"International Cooperative Ataxia Rating Scale (ICARS):~ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability.~Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst)."|baseline and 12 months||||ICARS points||Standard Deviation|Mean
1225839|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 3|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||pg/mL||Standard Deviation|Mean
1225840|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 2|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||pg/mL||Standard Deviation|Mean
1225841|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 1|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||pg/mL||Standard Deviation|Mean
1225842|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 3|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||nmol/L||Standard Deviation|Mean
1225843|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 2|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||nmol/L||Standard Deviation|Mean
1225844|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 1|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||nmol/L||Standard Deviation|Mean
1225845|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 3|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||pmol/L||Standard Deviation|Mean
1225846|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 2|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||pmol/L||Standard Deviation|Mean
1225847|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 1|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||pmol/L||Standard Deviation|Mean
1225848|NCT00696878|Secondary|Serum LH Levels in Treatment Cycle 3|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||IU/L||Standard Deviation|Mean
1225849|NCT00696878|Secondary|Serum LH Levels in Treatment Cycle 2|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||IU/L||Standard Deviation|Mean
1225850|NCT00696878|Secondary|Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||IU/L||Standard Deviation|Mean
1225851|NCT00696878|Secondary|Serum FSH Levels in Treatment Cycle 3|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||IU/L||Standard Deviation|Mean
1225852|NCT00696878|Secondary|Serum FSH Levels in Treatment Cycle 2|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||IU/L||Standard Deviation|Mean
1225853|NCT00696878|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||International Units (IU)/L||Standard Deviation|Mean
1225864|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa in Treatment Cycle 1|||number of embryos||Standard Deviation|Mean
1225854|NCT00696878|Secondary|Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy|The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa|||percentage of participants|||Number
1225855|NCT00696878|Secondary|Number of Participants With Ongoing Pregnancy in Any FTET Cycle|After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|10 weeks up to 9 months after ET within an FTET cycle|Participants who received corifollitropin alfa and had ET in any FTET cycle|||participants|||Number
1225856|NCT00696878|Secondary|Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3|Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy.|From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle|Participants who received corifollitropin alfa and had biochemical pregnancy in any of Treatment Cycles 1, 2 or 3|||participants|||Number
1225857|NCT00696878|Secondary|Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3|Miscarriage: Loss of the fetus without induction or instrumentation, also known as “spontaneous abortion.” Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan.|5-6 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had vital pregnancy in any of Treatment Cycles 1, 2 or 3|||participants|||Number
1225858|NCT00696878|Secondary|Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3|Miscarriage: Loss of the fetus without induction or instrumentation, also known as “spontaneous abortion.” Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan.|5-6 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had clinical pregnancy in any of Treatment Cycles 1, 2 or 3|||participants|||Number
1225859|NCT00696878|Secondary|Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3|Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|10 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had ongoing pregnancy in any of Treatment Cycles 1, 2 or 3|||participants|||Number
1225860|NCT00696878|Secondary|Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3|Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
1225861|NCT00696878|Secondary|Implantation Rate for Participants With ET|The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant.|Approximately 5-6 weeks after ET, within a treatment cycle|Participants who received corifollitropin alfa and had ET|||percentage of embryos||Standard Deviation|Mean
1225862|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa in Treatment Cycle 3|||number of embryos||Standard Deviation|Mean
1225863|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa in Treatment Cycle 2|||number of embryos||Standard Deviation|Mean
1225865|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had ET in Treatment Cycle 3|||participants|||Number
1225866|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had ET in Treatment Cycle 2|||participants|||Number
1225867|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had ET in Treatment Cycle 1|||participants|||Number
1225868|NCT00696878|Secondary|Number of Embryos Transferred|ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized.|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa and had ET|||number of embryos||Standard Deviation|Mean
1225869|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3|||number of embryos||Standard Deviation|Mean
1225870|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3|||number of embryos||Standard Deviation|Mean
1225871|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3|||number of embryos||Standard Deviation|Mean
1225872|NCT00696878|Secondary|Fertilization Rate|The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant.|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa and had IVF and/or ICSI|||percentage of oocytes||Standard Deviation|Mean
1225873|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3|||number of fertilized oocytes||Standard Deviation|Mean
1225874|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2|||number of fertilized oocytes||Standard Deviation|Mean
1226302|NCT00693498|Secondary|Median wrCRP Level|wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects|post op day 1 and 2|64 subjects in each group that received blood; all included in the analysis|||mg/dL||Full Range|Median
1225875|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1|||number of fertilized oocytes||Standard Deviation|Mean
1225876|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3, and were enrolled at a site using cyropreservation at the fertilized oocyte level|||number of fertilized oocytes||Standard Deviation|Mean
1225877|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2, and were enrolled at a site using cyropreservation at the fertilized oocyte level|||number of fertilized oocytes||Standard Deviation|Mean
1225878|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1, and were enrolled at a site using cyropreservation at the fertilized oocyte level|||number of fertilized oocytes||Standard Deviation|Mean
1225879|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3|||number of fertilized oocytes||Standard Deviation|Mean
1225880|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2|||number of fertilized oocytes||Standard Deviation|Mean
1225881|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1|||number of fertilized oocytes||Standard Deviation|Mean
1225882|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 3|||number of oocytes||Standard Deviation|Mean
1225893|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 2|||follicles||Standard Deviation|Mean
1227479|NCT00683904|Secondary|Total Body Clearance of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||Liters/hour||Standard Deviation|Mean
1225883|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 2|||number of oocytes||Standard Deviation|Mean
1225884|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 1|||number of oocytes||Standard Deviation|Mean
1225885|NCT00696878|Secondary|Number of Oocytes Retrieved in a Participant Among Entire Study Population|Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle|Participants who received corifollitropin alfa|||number of oocytes||Standard Deviation|Mean
1225886|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 3|||follicles||Standard Deviation|Mean
1225887|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 2|||follicles||Standard Deviation|Mean
1225888|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 1|||follicles||Standard Deviation|Mean
1225889|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 3|||follicles||Standard Deviation|Mean
1225890|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 2|||follicles||Standard Deviation|Mean
1225891|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 1|||follicles||Standard Deviation|Mean
1225892|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 3|||follicles||Standard Deviation|Mean
1225894|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 1|||follicles||Standard Deviation|Mean
1225895|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 3|||follicles||Standard Deviation|Mean
1225896|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 2|||follicles||Standard Deviation|Mean
1225897|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 1|||follicles||Standard Deviation|Mean
1225898|NCT00696878|Secondary|Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG|Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.|Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle|Participants who received corifollitropin alfa and (rec)hCG|||International Unit (IU)||Full Range|Median
1225899|NCT00696878|Primary|Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS)|OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.|Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
1225900|NCT00696878|Primary|Number of Participants With Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa|||participants|||Number
1225901|NCT00696878|Primary|Number of Participants With AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa|||participants|||Number
1225902|NCT00696878|Primary|Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
1225903|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
1225927|NCT00696800|Secondary|Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8|The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 8 onwards.|From Day 8 to Day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.|||IU||Full Range|Median
1225904|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
1225905|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
1225906|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
1225907|NCT00696878|Primary|Percentage of Participants With Clinically Relevant Immunogenicity|Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.|Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle|Participants who received corifollitropin alfa and had a post dose sample for anti-corifollitropin alfa antibody testing|||percentage of participants|||Number
1225908|NCT00696800|Secondary|Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer|Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.|Two weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.|||Percentage of participants|||Number
1225909|NCT00696800|Secondary|Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt|Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.|Two weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.|||Percentage of participants|||Number
1225910|NCT00696800|Secondary|Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy|The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity.|Up to day of miscarriage (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a vital pregnancy.|||Percentage of participants|||Number
1225911|NCT00696800|Secondary|Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy|The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth.|Up to day of miscarriage (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a clinical pregnancy.|||Percentage of participants|||Number
1225912|NCT00696800|Secondary|Percentage of Gestational Sacs (Implantation Rate)|The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred.|Up to 6 weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.|||Percentage of gestational sacs||Standard Deviation|Mean
1225913|NCT00696800|Secondary|Number of Embryos Transferred on Day 3|After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account.|Post fertilization Day 3 (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.|||Number of embryos||Standard Deviation|Mean
1226507|NCT00690898|Secondary|Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.||Week 12, 24, and 48|Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.|||percentage change||95% Confidence Interval|Mean
1225914|NCT00696800|Secondary|Number of Embryos Obtained on Day 3 Categorized by Quality|Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality.|Post fertilization Day 3 (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with IVF and/or ICSI, and excludes those who had embryos transferred or cryopreserved before Day 3.|||Number of embryos||Standard Deviation|Mean
1225915|NCT00696800|Secondary|Percentage of Fertilized Oocytes (Fertilization Rate)|The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI|Up to 18 hours after start of fertilization (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.Restricted to participants with IVF and/or ICSI.|||Percentage of fertilized oocytes||Standard Deviation|Mean
1225916|NCT00696800|Secondary|Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)|The number of oocytes used for ICSI was assessed, and categorized based on their quality|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. For participants who had ICSI; but also includes 3 participants whose oocytes were assessed, but ICSI was not performed.|||Number of oocytes||Standard Deviation|Mean
1225917|NCT00696800|Secondary|Number of Cumulus-oocyte-complexes|Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who underwent IVF.|||Number of cumulus-oocyte complexes||Standard Deviation|Mean
1225918|NCT00696800|Secondary|Number of Follicles Categorized by Size on the Day of hCG|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|Day of HCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection and with USS data available.|||Number of follicles||Standard Deviation|Mean
1225919|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 8|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|On Day 8 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 8.|||Number of follicles||Standard Deviation|Mean
1225920|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 5|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|On Day 5 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 5.|||Number of follicles||Standard Deviation|Mean
1225921|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 1|Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size.|On Day 1 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 1.|||Number of follicles||Standard Deviation|Mean
1225922|NCT00696800|Secondary|Serum Inhibin-B Levels During Stimulation|Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had Inhibin-B data available.|||pg/mL||Standard Deviation|Mean
1225923|NCT00696800|Secondary|Serum Progesterone (P) Levels During Stimulation|Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had P data available.|||nmol/mL||Standard Deviation|Mean
1225924|NCT00696800|Secondary|Serum Estradiol (E2) Levels During Stimulation|Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had E2 data available.|||pmol/L||Standard Deviation|Mean
1225925|NCT00696800|Secondary|Serum Luteinizing Hormone (LH) Levels During Stimulation|Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had LH data available.|||IU/L||Standard Deviation|Mean
1225926|NCT00696800|Secondary|Serum FSH Levels During Stimulation|Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had FSH data available.|||IU/L||Standard Deviation|Mean
1232660|NCT00640224|Secondary|Total Testosterone at Baseline and 6 Months|Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.|Baseline and 6 months||||ng/dL||Standard Error|Mean
1225928|NCT00696800|Secondary|Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1|The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 1 onwards.|From Day 1 to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.|||IU||Full Range|Median
1225929|NCT00696800|Primary|Mean Number of Oocytes Retrieved|Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.|||Number of oocytes||Standard Deviation|Mean
1225930|NCT00696800|Primary|Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)|An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.|Assessed at least 10 weeks after embryo transfer (up to 1 year)|Intent to Treat (ITT) population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.|||Percentage of participants|||Number
1225931|NCT00696787|Secondary|Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients|The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.|Baseline and 8 weeks|All randomized subjects who had taken at least one dose of double-blind test article, had a baseline primary efficacy evaluation, and had at least one primary efficacy evaluation on double-blind therapy. Subjects who did not complete the study due to its discontinuation were excluded.|||units on scale||Standard Error|Mean
1225932|NCT00696787|Primary|Change From Baseline on the Numeric Rating Scale (NRS)|The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.|Baseline and 8 weeks|The Modified Intent to Treat (MITT) population included all randomized subjects who had taken at least one dose of double-blind test article, who had a baseline primary efficacy evaluation, and who had at least one primary efficacy evaluation on double-blind therapy.|||units on scale||Standard Error|Mean
1225933|NCT00696774|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225934|NCT00696774|Secondary|Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks|The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225935|NCT00696774|Secondary|Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks|A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores <=47 (men) and <=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section.|Baseline, 4 Weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225936|NCT00696774|Secondary|Change From Baseline in Patient Global Impression - Improvement (PGI–I) Scale Score at 8 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1226006|NCT00696436|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1225937|NCT00696774|Secondary|Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225938|NCT00696774|Secondary|Change From Baseline in the Clinical Global Impression – Severity (CGI-Severity) Scale at 8 Weeks|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225939|NCT00696774|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks|The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225940|NCT00696774|Secondary|Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks|The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225941|NCT00696774|Secondary|Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks|The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225942|NCT00696774|Secondary|Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks|The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225943|NCT00696774|Secondary|Change From Baseline HAMD-17 Maier Subscale at 8 Weeks|"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225944|NCT00696774|Secondary|Change From Baseline HAMD-17 Core Subscale at 8 Weeks|"The Core subscale (Items 1,2,3,7,8) evaluates core symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225945|NCT00696774|Secondary|Change From Baseline HAMD-17 Total Score at 8 Weeks|The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225946|NCT00696774|Secondary|Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks|"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a >=50% reduction in the Maier subscale score from baseline."|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Percentage of participants||95% Confidence Interval|Number
1225959|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)|Change from baseline in urine-haemoglobin was measured in terms of number of subjects in each category (negative, trace, small, moderate/large and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
1232661|NCT00640224|Secondary|Total Fat Mass at Baseline and 6 Months|DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.|Baseline and 6 months||||Kg||Standard Error|Mean
1225947|NCT00696774|Primary|Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks|"BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a >=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 4 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1225948|NCT00696761|Primary|Treatment Efficacy Was Analyzed by Validated Symptom Scores.|Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.|12 month|The population analyzed included participants receiving drug for 12 months|||score||Standard Deviation|Mean
1225949|NCT00696761|Secondary|Changes of International Continence Society (ICS)-Male Questionnaire, Uroflowmetry, Residual Urine Volume, and Patient's Global Impression of Improvement||3month, 6month, 12month|||||||
1225950|NCT00696761|Primary|Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment|"international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome~Baseline score minus 12-month score"|12months||||score||Standard Deviation|Mean
1225951|NCT00696696|Secondary|Median Overall Survival (mOS)|Median overall survival is defined as the time when 50% of the patients are alive from the start of the treatment.|up to 2 years|Based on the number of patients treated.|||days||95% Confidence Interval|Median
1225952|NCT00696696|Secondary|Objective Response Rate|The response rate is the percentage of the patients who have a complete response or partial response based on RECIST from the start of the treatment. The response is evaluated every 2 cycles by radiologic methods (e.g., computer tomography (CT)).|up to 1 year|Based on the number of patients evaluable for response. The evaluable patients were those patients who received any treatment and had first response assessment followed by at least one confirmatory scan.|||percentage of patients|||Number
1225953|NCT00696696|Primary|4-month Progression Free Survival (PFS) Rate|The PFS rate at 4 months is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment. Disease progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Radiological measurements to determine progression is performed every 2 cycles.|4 months|Based on the number of patients treated.|||percentage of patients|||Number
1225954|NCT00696657|Secondary|Percentage of Subjects Developing Anti-semaglutide Antibodies|Antibodies were measured after 12-week of treatment at week 17; percentage of participants with positive anti-semaglutide antibodies are presented here. Assessments of antibodies were not done for subjects allocated to the open-label liraglutide treatment arms.|After 12 weeks of treatment|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Percentage (%) of participants|||Number
1225955|NCT00696657|Secondary|Change From Baseline in Calcitonin|Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||ng/L||Standard Deviation|Mean
1225956|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)|Change from baseline in urine-protein was measured in terms of number of subjects in each category at week 0 (negative, 0.3 g/L, 1.0 g/L and missing) and week 12 (negative, trace, 0.3 g/L, 1.0 g/L, >=3.0 g/L and missing). i.e., change in each category in terms of number of subjects from week 0 to week 12.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
1225957|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)|Change from baseline in urine-pH was measured in terms of number of subjects in each category (pH=6.0, 6.5, 7.0, 7.5, 8.0, >=8.5 and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
1225958|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)|Change from baseline in urine-ketone was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
1226007|NCT00696436|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1225960|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)|Change from baseline in urine-glucose was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L, or missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
1225961|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)|Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
1225962|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)|Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
1225963|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)|Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
1225964|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)|Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||umol/L||Standard Deviation|Mean
1225965|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)|Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
1225966|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)|Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
1225967|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)|Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||umol/L||Standard Deviation|Mean
1225968|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)|Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||U/L||Standard Deviation|Mean
1225969|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)|Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||U/L||Standard Deviation|Mean
1225970|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)|Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||U/L||Standard Deviation|Mean
1225971|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)|Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||g/L||Standard Deviation|Mean
1225972|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)|Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
1225973|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)|Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Trillion cells/litre (10^12/L)||Standard Deviation|Mean
1225974|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)|Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
1225975|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)|Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
1225976|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)|Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
1225977|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)|Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
1225978|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)|Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Gram/litre (g/L)||Standard Deviation|Mean
1225979|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)|Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Litre/litre (L/L)||Standard Deviation|Mean
1225980|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)|Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
1225981|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)|Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
1225982|NCT00696657|Secondary|Change From Baseline in Vital Signs (Blood Pressure; DBP)|Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmHg||Standard Deviation|Mean
1225983|NCT00696657|Secondary|Change From Baseline in Vital Signs (Blood Pressure; SBP)|Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmHg||Standard Deviation|Mean
1225984|NCT00696657|Secondary|Change From Baseline in Vital Signs (Pulse)|Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Beats/minute||Standard Deviation|Mean
1225985|NCT00696657|Secondary|Change From Baseline in ECG|A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as “week -2, week 12”. Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant [NCS] or abnormal clinically significant [CS]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12).|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
1225986|NCT00696657|Secondary|Percentage of Subjects With Hypoglycaemic Episode|The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was <3.1 mmol/L (56 mg/dL). Symptoms only: If the subject was able to treat himself or herself and measured plasma glucose was >=3.1 mmol/L (56 mg/dL) or no plasma glucose measurement was done.|After 12 weeks of treatment|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Percentage (%) of subjects|||Number
1225987|NCT00696657|Secondary|Percentage of Subjects With an Adverse Events|The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.|After 12 weeks of treatment.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Percentage (%) of subjects|||Number
1225988|NCT00696657|Primary|HbA1c|Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.|After 12 weeks of treatment.|The full analysis set included all randomised subjects who had been exposed to at least 1 dose of the trial product (placebo/semaglutide/liraglutide). Four subjects mistakenly received a different treatment instead of the randomised treatment. The randomised treatment was applied regardless of the treatment actually received.|||Percentage (%) of HbA1c||Standard Deviation|Mean
1225989|NCT00696618|Secondary|D(Average) at Two Hours|Mean proximal residence distance of radio-signal from anus as measured on SPECT/CT|two hours following dosing of intervention|All participants who received one dose of each intervention and completed all study visits were included in the analysis.|||centimeters||Inter-Quartile Range|Median
1225990|NCT00696618|Secondary|Radiolabel Area Under the Curve (AUC 0-24 hr)|Percent of radiolabel dose administered was determined by plasma sampling at standardized intervals over 24 hours. AUC was then calculated using the trapezoidal rule and reported as x10 log 7 microcurie-hours/mL|24 hours following each intervention|All participants who received one dose of each intervention and completed all study visits were included in the analysis.|||10 log 7 microcurie-hours/mL||Inter-Quartile Range|Median
1226004|NCT00696436|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1226005|NCT00696436|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1225991|NCT00696618|Primary|Mucosal Toxicity Using Histopathology|"Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded.~Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention."|One hour following enema exposure|All participants who received one dose of each intervention and completed all study visits were included in the analysis.|||units on a scale|colon biopsies|95% Confidence Interval|Geometric Mean
1225992|NCT00696488|Primary|Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.|Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used|12 weeks||||percentage of prescribed doses||Full Range|Mean
1225993|NCT00696449|Primary|Adherence to Treatment|Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap|12 weeks||||Percent of prescribed doses||Full Range|Median
1225994|NCT00696436|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1225995|NCT00696436|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1225996|NCT00696436|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1225997|NCT00696436|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1225998|NCT00696436|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1225999|NCT00696436|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1226000|NCT00696436|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1226001|NCT00696436|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1226002|NCT00696436|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1226003|NCT00696436|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1226008|NCT00696436|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1226009|NCT00696423|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period after booster vaccination||||subjects|||Number
1226010|NCT00696423|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after booster vaccination||||subjects|||Number
1226011|NCT00696423|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.|During the 4-day follow-up period after booster vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with a documented dose.|||subjects|||Number
1226012|NCT00696423|Secondary|The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||subjects|||Number
1226013|NCT00696423|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Geometric mean concentrations are given in EL.U/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1226014|NCT00696423|Secondary|Anti-tetanus Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||IU/mL||95% Confidence Interval|Geometric Mean
1226015|NCT00696423|Secondary|Anti-diphtheria Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||IU/mL||95% Confidence Interval|Geometric Mean
1226016|NCT00696423|Secondary|Anti-PRP Antibody Concentrations|Geometric mean concentrations are given in μg/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||μg/mL||95% Confidence Interval|Geometric Mean
1226017|NCT00696423|Primary|The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||subjects|||Number
1226018|NCT00696423|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1226019|NCT00696423|Primary|Anti-tetanus Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||IU/mL||95% Confidence Interval|Geometric Mean
1226020|NCT00696423|Primary|Anti-diphtheria Toxoid Antibody Concentrations|Geometric mean concentrations are given in international Unit per milliliter (IU/mL).|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||IU/mL||95% Confidence Interval|Geometric Mean
1226021|NCT00696423|Primary|Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations|Geometric mean concentrations are given in microgram per milliliter (μg/mL).|One month after booster vaccination|Analysis was performed on the According To Protocol (ATP) cohort for immunogenicity.|||μg/mL||95% Confidence Interval|Geometric Mean
1226022|NCT00696410|Other Pre-specified|Change From Baseline in Serum Measures of of Myeloperoxidase (MPO) After 10 Months of Zinc Acetate Treatment|Change from baseline in serum myeloperoxidase (MPO) after 10 months of zinc acetate treatment in patients with systolic heart failure and compared with a single measure from healthy controls|Baseline (time 0) and 10 months|Healthy controls only analyzed at one time point|||units per L||Inter-Quartile Range|Median
1226023|NCT00696410|Other Pre-specified|Change From Baseline in Serum Superoxide Dismutase|Change from baseline in serum superoxide dismutase after 10 months of zinc acetate in patients with systolic heart failure and compared with a single measure in healthy controls|Baseline (time 0) and 10 months|Specimens from healthy controls were only analyzed at one time frame.|||units per microL||Inter-Quartile Range|Median
1226024|NCT00696410|Other Pre-specified|Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls|Change in PIIINP from baseline after 10 months of Zinc Acetate in patients with systolic heart failure and compared with a single measure in healthy controls|Baseline (time 0) and 10 months|Specimens from healthy controls were only analyzed at one time frame.|||ng/ml||Inter-Quartile Range|Median
1226025|NCT00696410|Secondary|Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure|Change from baseline in serum isoprostane 10 months after Zn Acetate in patients with systolic heart failure and compared with a single measure in healthy subjects|Baseline (time 0) and 10 months|power calculation using prior studies of the above laboratories. For Controls, a single measure was obtained without further followup.|||pg/ml||Inter-Quartile Range|Median
1226026|NCT00696410|Primary|Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls.|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times daily for 10 months. The change from baseline in markers of cardiac collagen turnover (PINP) in patients with systolic heart failure after 10 months of zinc acetate was measured and compared with a single measure from healthy controls.|Baseline (time 0) and after 10 months of Zinc Acetate.|Power was determined using prior studies examining the change in PINP and (separately) PIIINP in heart failure following administration of aldactone. Results below are PINP. For Controls, a single measure was obtained without further followup.|||ng/ml||Inter-Quartile Range|Median
1226027|NCT00696384|Secondary|Number of Participants With Adverse Events in the Double-Blind Baseline Phase|Treatment-emergent adverse events defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after last dose of study drug, or within 30 days after the last dose of study drug for SAE. A SAE is defined as any untoward medical occurrence that either results in death; is life-threatening; requires hospitalization; results in persistent or significant disability/incapacity; leads to a congenital anomaly/birth defect; or is an important medical event.|Double-blind Baseline/Week 26 to Week 32||||participants|||Number
1226028|NCT00696384|Secondary|Number of Participants With Adverse Events During the Open-Label Phase|Treatment-emergent adverse events defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after last dose of study drug, or within 30 days after the last dose of study drug for serious adverse event (SAE). A SAE is defined as any untoward medical occurrence that either results in death; is life-threatening; requires hospitalization; results in persistent or significant disability/incapacity; leads to a congenital anomaly/birth defect; or is an important medical event.|Baseline to Week 26||||participants|||Number
1226029|NCT00696384|Secondary|Change From Open Label Baseline (Week 0) in Sitting Clinic Systolic Blood Pressure to Week 26|The change from baseline in sitting clinic systolic blood pressure measured at final visit or week 26.|Baseline and Week 26.|Safety analysis set with last observation carried forward.|||mmHg||Standard Deviation|Mean
1226030|NCT00696384|Secondary|Change From Open Label Baseline (Week 0) in Sitting Clinic Diastolic Blood Pressure to Week 26|The change from baseline in sitting clinic diastolic blood pressure measured at final visit or week 26.|Baseline and Week 26.|Safety analysis set with last observation carried forward.|||mmHg||Standard Deviation|Mean
1226031|NCT00696384|Secondary|Change From Double-blind Baseline (Week 26) in Sitting Clinic Systolic Blood Pressure to Week 32|The change in sitting clinic systolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26.. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.|Double-blind Baseline (Week 26) and Week 32.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226032|NCT00696384|Primary|Change From Double-blind Baseline (Week 26) in Sitting Clinic Diastolic Blood Pressure to Week 32|The change in sitting clinic diastolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.|Double-blind Baseline (Week 26) and Week 32.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226033|NCT00696293|Primary|Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks|"The McGill Pain Questionaire, short form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The McGill Pain Questionaire score ranged from 0 (none) to 45 (severe).~A larger reduction of the score from baseline to 12 weeks would represent a better outcome"|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1226034|NCT00696293|Primary|Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks|"The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome~Larger reduction between MADRS from baseline to 12 weeks would represent better outcome"|baseline and 12 weeks|description of median change|||units on a scale||Standard Deviation|Mean
1226035|NCT00696241|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1226036|NCT00696241|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1226037|NCT00696241|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1226062|NCT00696020|Secondary|Tmax,ss Olodaterol [h]|"Time from last dosing to maximum concentration of Olodaterol in plasma at steady state (tmax,ss) after 4 weeks treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||hours||Full Range|Median
1226038|NCT00696241|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226039|NCT00696241|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226040|NCT00696241|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226041|NCT00696241|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226042|NCT00696241|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226043|NCT00696241|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226044|NCT00696241|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226045|NCT00696241|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226046|NCT00696241|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226047|NCT00696241|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226048|NCT00696241|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226049|NCT00696241|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1226050|NCT00696137|Primary|Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.|Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.|3 years||||Participants|||Count of Participants
1226063|NCT00696020|Secondary|Cmax,ss Olodaterol [pg/mL]|"Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss) after 4 weeks of treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK or had insufficient data.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1226051|NCT00696072|Secondary|Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)|All participants who received at least one dose of study drug were summarized. The participants were analyzed as per the treatment arm to which they were originally randomized.|||participants|||Number
1226052|NCT00696072|Secondary|Median Time to Treatment Failure (TTF) - ITT Population|Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|ITT population: All participants enrolled in the study.|||Months||95% Confidence Interval|Median
1226053|NCT00696072|Secondary|Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population|Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants.|At 6 months and at 12 months|ITT population=Includes all participants registered on the study. n= number at risk|||percentage of participants||95% Confidence Interval|Number
1226054|NCT00696072|Secondary|Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib|Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|Participants who changed their treatment regimen from single-agent letrozole to letrozole + dasatinib during the study.|||percentage of participants||95% Confidence Interval|Number
1226055|NCT00696072|Secondary|Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population|PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014.|Day 1 to Study Completion (approximately 6 years)|ITT population includes all participants enrolled in the study. The participants were analyzed as per the treatment arm to which they were originally randomized.|||months||95% Confidence Interval|Median
1226056|NCT00696072|Secondary|Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression|CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|All treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of study drug were analyzed. The participants are analyzed as per the treatment arm to which they were originally randomized.|||participants|||Number
1226057|NCT00696072|Primary|Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population|CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|Evaluable Population was defined as all treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of randomized study drug. Participants presented in the treatment arm to which they were originally randomized.|||participants|||Number
1226058|NCT00696020|Secondary|AUC(0-3h,ss) Tiotropium [pg*h/mL]|Area under the concentration-time curve of Tiotropium at steady state (AUC(0-3h,ss)) from 0 to 3 hours post dosing after 4 weeks of treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1226059|NCT00696020|Secondary|Tmax,ss Tiotropium [h]|Time from last dosing to maximum concentration of Tiotropium in plasma at steady state (tmax,ss) after 4 weeks of treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||hours||Full Range|Median
1226060|NCT00696020|Secondary|Cmax,ss Tiotropium [pg/mL]|Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss) after 4 weeks treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1226061|NCT00696020|Secondary|AUC(0-1h,ss) Olodaterol [pg*h/mL]|"Area under the concentration-time curve of Olodaterol in plasma at steady state (AUC(0-1h,ss)) from 0 to 1 hour post dosing after 4 weeks of treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1226064|NCT00696020|Secondary|Clinically Significant Anormalities (Laboratory Data); Marked Changes From Baseline for Vital Signs, Notable Change in ECG and New Onset of ECG Abnormalities|"Possible clinically significant anormalities (laboratory data); marked changes from baseline for vital signs, notable change in ECG and new onset of ECG abnormalities. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AEs).~All AEs with an onset after the first dose of study medication up to 21 days after the last dose of study medication were to have been assigned to the Treatment Period."|From first dose up to 21 days after last dose of study medication.|Treated Set.|||participants|||Number
1226065|NCT00696020|Secondary|Patient’s Global Rating|"Patient’s Global Rating at the end of the 4 week treatment period.~Patients rated their health (respiratory condition) at Day 29 (compared to the day before they commenced treatment with study medication) on a 7-point scale as “very much better (1), much better (2), a little better (3), no change (4), a little worse (5), much worse (6), or very much worse (7)”. The assessment was made prior to pulmonary function testing and all other study procedures. The Patient’s Global Rating was also completed before the Physician’s Global Evaluation.~The means are adjusted, based on an ANCOVA with terms for treatment, centre (centre random, treatment effect fixed)."|4 weeks|Full Analysis Set.|||units on a patient's global rating score||Standard Error|Least Squares Mean
1226066|NCT00696020|Secondary|Physician’s Global Evaluation|"Measured a 8-point scale, from 1 (poor) to 8 (excellent), as judged by the physician, over 4 weeks of treatment.~The physician made a global evaluation at the end of the Baseline Period (Test Day 1) and at each visit thereafter. These assessments were made prior to pulmonary function testing and reflected the physician’s opinion of the patient's overall clinical condition. This evaluation was based on the need for concomitant medication, number and severity of COPD exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, and other relevant clinical observations.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 week, 2 weeks and 4 weeks|Full Analysis Set.|||units on a scale||Standard Error|Least Squares Mean
1226067|NCT00696020|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day|The means are adjusted, Based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).|Throughout the 4 weeks treatment period|Full Analysis Set.|||occasion(s)||Standard Error|Least Squares Mean
1226068|NCT00696020|Secondary|Weekly Mean Evening PEF [L/Min]|"The patient will record twice daily peak flow measurements using an AM2+ device. The evening measurement will be performed at bedtime.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|Throughout the 4 weeks treatment period|Full Analysis Set.|||L/min||Standard Error|Mean
1226069|NCT00696020|Secondary|Weekly Mean Pre-dose Morning PEF [L/Min]|"The patient will record twice daily peak flow measurements using an Asthma Monitor®Am2+ (AM2+) device. Morning measurements will be performed immediately upon arising after the patient has cleared out mucus, prior to administration of trial and/or rescue medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|Throughout the 4 week treatment period|Full Analysis Set.|||L/min||Standard Error|Least Squares Mean
1226070|NCT00696020|Secondary|PEF (Unsupervised) AUC(6-12h) Response [L/Min] After First Administration and 1,2 and 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) AUC(6-12h) response is defined as change from the baseline value. AUC(6-12h) will be calculated as the area under the curve from 6 to 12 hours on the various test days using the trapezoidal rule, divided by the full duration (6 hours) to report in litres/min. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|6 h, 9 h and 12 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L/min||Standard Error|Least Squares Mean
1226071|NCT00696020|Secondary|FEV1 (Unsupervised) AUC(6-12h) Response [L] After First Administration and 1,2 and 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) AUC(6-12h) response is defined as change from the baseline value. AUC(6-12h) will be calculated as the area under the curve from 6 to 12 hours on the various test days using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|6 h, 9 h and 12 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226072|NCT00696020|Secondary|FEV1 and PEF (Unsupervised) AUC(0-6h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|AUC(0-6h) for FEV1, and PEF (unsupervised) were not studied because the pertinent information from the unsupervised pulmonary function tests was for the time interval from 9 to 12 hours post-dosing.|After first administration, 1 week, 2 weeks and 4 weeks|Full Analysis Set.||||||
1226073|NCT00696020|Secondary|PEF Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226113|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226074|NCT00696020|Secondary|FVC Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"FVC (forced vital capacity) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226075|NCT00696020|Secondary|FEV1 Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226076|NCT00696020|Secondary|PEF AUC(0-6h) Response [L] After 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226077|NCT00696020|Secondary|FVC AUC(0-6h) Response [L] After 4 Weeks of Treatment|"FVC (forced vital capacity) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226078|NCT00696020|Secondary|FEV1 AUC(0-6h) Response [L] After 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226079|NCT00696020|Secondary|PEF AUC(0-3h) Response [L/Min] After First Administration and After 1, 2 and 4 Weeks of Treatment.|"PEF (peak expiratory flow rate L/min) AUC(0-3h) response is defined as change from the baseline value. AUC(0-3h) will be calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres/min. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.|||L/min||Standard Error|Least Squares Mean
1226080|NCT00696020|Secondary|FVC AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment.|"FVC (forced vital capacity) AUC(0-3h) response is defined as change from the baseline value. AUC(0-3h) was calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres. Baseline FVC was defined as the mean of the 2 pre-treatment FVC values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226081|NCT00696020|Secondary|FEV1 AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"Response is defined as change from the baseline value. AUC(0-3h) (area under the curve) was calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226171|NCT00694603|Primary|Response Rate by CT Scan Using RECIST Criteria||8 weeks|The trial used a Simon two-stage design, which enrolled 18 pts in the first stage and was to proceed to enroll an additional 28 evaluable patients if 1 or more response was observed in the first group. This design provided a 57% chance of early termination if the true response rate was <3%. PFSand OS were calculated using the Kaplan-Meier method.|||participants|||Number
1226082|NCT00696020|Secondary|Trough FVC Response [L] After 1, 2 and 4 Weeks of Treatment|"Trough FVC (forced vital capacity) was defined as the mean of the 2 FVC values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FVC response was defined as the change from baseline in trough FVC. Baseline FVC was defined as the mean of the 2 pre-treatment FVC values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|Baseline, 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226083|NCT00696020|Secondary|Trough FEV1 Response [L] After 1 and 2 Weeks of Treatment.|"Trough FEV1 (forced expiratory volume in 1 second) was defined as the mean of the 2 FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 15."|Baseline, 1 week and 2 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
1226084|NCT00696020|Primary|Trough FEV1 Response [L] After 4 Weeks of Treatment|"Trough FEV1 (Forced expiratory volume in 1 second) was defined as the mean of the two FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed)."|Baseline and 4 weeks|Full Analysis Set (FAS). The FAS consisted of all patients who received at least 1 dose of study medication and had baseline data (pre-treatment at the end of the 2-week baseline) for at least 1 efficacy endpoint. For this trial all randomized and treated patients were included in the FAS.|||L||Standard Error|Least Squares Mean
1226085|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.|The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks.|Full Analysis Set.|||mmHg||Standard Deviation|Mean
1226086|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.|The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks.|Full Analysis Set.|||mmHg||Standard Deviation|Mean
1226087|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2|The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks|Full Analysis Set.|||mmHg||Standard Deviation|Mean
1226088|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.|The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks|Full Analysis Set.|||mmHg||Standard Deviation|Mean
1226089|NCT00695955|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|56 weeks.|Full Analysis Set.|||participants|||Number
1226090|NCT00695955|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|56 weeks.|Full Analysis Set.|||participants|||Number
1226091|NCT00695903|Secondary|Number of Participants With Treatment Cure at Test of Cure (TOC)/Safety Visit|Investigator's assessment of clinical response. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy.|Test of Cure (TOC) Visit (35 to 49 days post-therapy, approximately week 8)|Subset of modified intent-to-treat population who completed TOC/Safety visit|||participants|||Number
1226092|NCT00695903|Primary|Number of Participants With Elevated Serum Creatinine|Number of participants with treatment-emergent serum creatinine increases ≥0.5 mg/dL (for patients with a baseline value ≤3.0 mg/dL) or ≥1.0 mg/dL (for patients with a baseline value >3.0 mg/dL) by the EOT visit.|On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)|All subjects who received at least one dose of study medication (Safety Population). Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.|||participants|||Number
1226114|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226093|NCT00695903|Secondary|Number of Participants With Treatment Cure at End of Therapy (EOT) Visit|Investigator's assessment of treatment cure. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy.|End of Therapy (median day 12 and 6.5 in daptomycin and vancomycin modified intent-to treat population, respectively)|Patients who met the continuation criteria (modified intent-to-treat) and had a EOT assessment of clinical outcome.|||participants|||Number
1226094|NCT00695903|Primary|Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations|Number of participants with treatment-emergent CPK elevations ≥5 x upper limit of normal (≥1,000 U/L) by the EOT visit.|On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)|All subjects who received at least one dose of study medication (Safety Population). Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.|||Participants|||Number
1226095|NCT00695864|Primary|Change in Withdrawal Symptoms With Placebo and With Ondansetron|Subjective Opioid Withdrawal Scale: Participants were asked to rate, from 0 to 4, their experience of 15 withdrawal symptoms. Scores for each participant were derived from the sum of their withdrawal symptoms score (minimum:0, maximum: 60). A higher score indicates more symptoms experienced and/or at a greater degree of severity.|Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron|9 participants and 13 independent trials (3 patients had more than 1 distinct withdrawal episode) were analyzed. Of the 14 participants assigned to intervention, 5 were withdrawn from the study and/or analysis.|||Percent change||Standard Error|Mean
1226096|NCT00695669|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
1226097|NCT00695669|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 51-day follow-up period (Days 0-50) after first vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
1226098|NCT00695669|Secondary|Number of Subjects With Medically Attended Adverse Events (MAEs).|A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
1226099|NCT00695669|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature ≥ 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.|||Subjects|||Number
1226100|NCT00695669|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.|||Subjects|||Number
1226101|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.|Subjects with vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
1226102|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
1226172|NCT00694564|Secondary|Safety|Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.|0, 2 weeks, 1 month, 2 month|||||||
1226173|NCT00694564|Primary|Wong-Baker FACES Pain Rating Scale|We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).|0, 2 weeks, 1 month, 2 months||||units on a scale||Standard Deviation|Mean
1226103|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At 7, 14 and 21 days after the second dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
1226104|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226105|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226106|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226107|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226108|NCT00695669|Secondary|Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|The GMFR is presented as the GMT ratio between GMTs at Day 42/182 and at Day 0.|At Days 0, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
1226109|NCT00695669|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
1226110|NCT00695669|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
1226111|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226112|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226115|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226116|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226117|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226118|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226119|NCT00695669|Primary|Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.|At Day 0 and at Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
1226120|NCT00695669|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.|At Day 0 and at Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
1226121|NCT00695669|Primary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
1226122|NCT00695578|Primary|Mean Severity Score|The change in the Mean Severity Score from Baseline to Week 4 (or end of treatment) as measured by the Mean Combined Severity Scores for Erythema, Scab, and Thickness on a scale of 0-4 with 0=None 1=slight 2=mild 3= moderate 4= severe|4 weeks||||units on a scale||Standard Deviation|Mean
1226123|NCT00695565|Secondary|Change in Blood Pressure From Baseline to Week 12|Systolic and Diastolic Blood Pressure were measured at clinic visits. This outcome assesses the change in blood pressure from Baseline to Week 12 of treatment.|Baseline and Week 12|ITT (Intent-to-Treat)|||mmHg||Standard Deviation|Mean
1226124|NCT00695565|Secondary|Clinician Global Impression of Change (CGIC) at Week 12|At Week 12, the Investigator was asked to independently rate the subject's total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.|Week 12|All subjects with a CGIC score were analyzed.|||percentage of subjects|||Number
1226125|NCT00695565|Secondary|Patient Global Impression of Change (PGIC) at Week 12|At Week 12 the subject was asked to rate their total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.|Week 12|All subjects with a PGIC score were analyzed.|||percentage of subjects|||Number
1226134|NCT00695565|Secondary|Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale. Subjects were asked to record the worst pain in their feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (greater pain relief)."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).|||units on a scale||Standard Deviation|Mean
1226126|NCT00695565|Secondary|Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score|The McGill Pain Questionnaire asks subjects to rate 15 different kinds of pain, each on a scale of 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Severe). The total score is a sum of the individual ratings and has a range from 0 to 45, where higher numbers indicate more pain. The 15 types of pain assessed are throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, and punishing-cruel. This scale was completed at the Baseline and Week 12 clinic visits. The change from Baseline is calculated as the Week 12 total score minus the Baseline total score, so greater negative numbers indicate more improvement (pain relief).|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
1226127|NCT00695565|Secondary|Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)|The HADS was completed at the Baseline and Week 12 clinic visits. The Anxiety Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Anxiety, 11-14 indicates Moderate Anxiety, and 15-21 indicates Severe Anxiety. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
1226128|NCT00695565|Secondary|Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)|The HADS was completed at the Baseline and Week 12 clinic visits. The Depression Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Depression, 11-14 indicates Moderate Depression, and 15-21 indicates Severe Depression. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
1226129|NCT00695565|Secondary|Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)|Subjects rated overall quality of sleep over the past week using a 100 mm Visual Analog Scale (VAS) where 100=Excellent and 0=Very Poor. This scale was completed during clinic visits. Change from Baseline is a positive value where quality of sleep improved.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
1226130|NCT00695565|Secondary|Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation|"The Brief Pain Inventory was completed by the subject at clinic visits. The Functional Interference Scale (of 0 to 70) is a composite score that measures the degree to which pain interferes with mood, walking, work, relationships, sleep, general activity, and enjoyment of life. The composite score is a sum of the seven individual question scores. Each individual question is rated in reference to pain over the past 24 hours on a scale of 0 to 10, where 0 indicates that pain does not interfere and 10 indicates that pain completely interferes with that function, so lower scores represent better outcomes on this scale.~The change in functional interference is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement."|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
1226131|NCT00695565|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation|"The Brief Pain Inventory was completed by the subject at clinic visits. The Severity Scale (of 0 to 40) is a composite score, which is the sum of the individual ratings for worst pain, least pain, average pain, and current pain. Each individual question is rated on a scale of 0 to 10, where 0 indicates No Pain and 10 indicates Pain as bad as you can imagine. The change in pain severity is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (pain relief)."|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
1226132|NCT00695565|Secondary|Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).|||percentage of subjects|||Number
1226133|NCT00695565|Secondary|Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).|||percentage of subjects|||Number
1226169|NCT00695019|Secondary|Sustained Virologic Response Rate|Percentage of participants who remained HCV RNA negative throughout the study|48 weeks|Intent-to-treat|||percentage of participants|||Number
1226135|NCT00695565|Secondary|Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. A weekly average was calculated from the daily scores for each week. The change in pain is represented as the average weekly score minus Baseline, so greater negative numbers represent more improvement (more pain relief)."|Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation)|||units on a scale||Standard Deviation|Mean
1226136|NCT00695565|Primary|Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain.~The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief)."|Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was mLOCF (modified Last Observation Carried Forward): LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication (in which case Baseline Observation Carried Forward (BOCF) was used).|||units on a scale||Standard Deviation|Mean
1226137|NCT00695500|Other Pre-specified|BOLD Response to Alcohol Cue|Percent BOLD signal change during Alcohol Food Incentive Delay Task (Alcohol - Neutral)|fMRI session following 2 weeks of treatment|sample that completed the assessment|||Percent Signal Change||Standard Error|Mean
1226138|NCT00695500|Secondary|Alcohol Urges|"Peak Alcohol Urge Questionnaire Score during IV alcohol self-administration. Scale: Alcohol Urge Questionnaire. Contains 8 items, each item scored on a likert scale from 1 to 7.~Range: Total scores range between 8 and 64. Higher scores indicate higher urges for alcohol."|2.5 hr session following 3 weeks of treatment|sample that completed the assessment|||Units on a scale||Standard Error|Mean
1226139|NCT00695500|Primary|Alcohol Consumption|Peak Breath Alcohol Concentration during IV alcohol self-administration|2.5 hr session following 3 weeks of treatment|sample that completed the assessment|||mg/%||Standard Error|Mean
1226140|NCT00695435|Secondary|Tobramycin Tear Concentration Area Under the Curve (AUC)|Trapezoidal AUC was calculated from 2 to 18 minutes.|2 to 18 minutes post administration||||min*ug/mL||Standard Deviation|Mean
1226141|NCT00695435|Primary|Tobramycin Tear Concentration Cmax (Maximum Concentration)|Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject’s right eye for each treatment period.|2, 4, 6, 12, and 18 minutes||||µg/mL||Standard Deviation|Mean
1226142|NCT00695409|Secondary|Number of Patients With RIT/ZBEAM Developing Therapy Induced MDS and AML|Patient receiving the full treatment of RIT/ZBEAM developed therapy induced MDS or AML.|From peripheral stem cell infusion (Day0 ASCT) to onset of therapy induced MDS/AML, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis.|||Participants|||Count of Participants
1226143|NCT00695409|Secondary|Time to Platelet Recovery|Platelet recovery was defined as the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions.|From peripheral stem cell infusion (Day0 ASCT) till the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions|6 patients did not receive full treatment so are excluded from the result analysis.|||Days||95% Confidence Interval|Median
1226144|NCT00695409|Secondary|Time to Neutrophil Recovery|Neutrophil recovery was defined as the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.|From peripheral stem cell infusion (Day0 ASCT) till the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.)|6 patients did not receive full treatment so are excluded from the result analysis.|||Days||95% Confidence Interval|Median
1226145|NCT00695409|Secondary|100-Day Treatment-Related Mortality|The cumulative incidence was estimated after taking into account the competing risk of relapse post-ASCT.|From peripheral stem cell infusion (Day0 ASCT) to death due to any couse, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis.|||Percentage of Participants (%)||95% Confidence Interval|Number
1226146|NCT00695409|Secondary|Number of Patients With Grade 3-4 Bearman Toxicities.|Toxicities were recorded using the modified Bearman Scale for non-hematologic adverse events.|From initial of study treatment to Day 100 post-ASCT||||Participants|||Count of Participants
1226147|NCT00695409|Secondary|Number of Patients With Active Disease at ASCT Achieving CR/PR by Day 100 After ASCT|Responses are assessed using the Revised Criteria for Malignant Lymphoma Response Definitions for Clinical Trials (Cheson et al. 2007). Complete Response (CR) defined as disappearance of all evidence of disease. Partial Response (PR) defined as regression of measurable disease and no new sites.|Up to Day 100 post-ASCT||||Participants|||Count of Participants
1226148|NCT00695409|Secondary|2-Year Cumulative Incidence of Progression|The cumulative incidence was estimated after taking into account the competing risk of early death.|From peripheral stem cell infusion (Day0 ASCT) to date of first observation of progressive disease or relapsed disease, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis|||Percentage of Participants (%)||95% Confidence Interval|Number
1226149|NCT00695409|Secondary|2-Year Overall Survival|Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood’s formula. [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]|From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis.|||Percentage of Participants (%)||95% Confidence Interval|Number
1226170|NCT00694603|Secondary|Progression-free Survival||From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months||||months||95% Confidence Interval|Median
1226150|NCT00695409|Primary|2-Year Progression-Free Survival|Progression-free survival (PFS) was defined as time from peripheral stem cell infusion to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood’s formula [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]|From peripheral stem cell infusion (Day0 ASCT) to first observation of progressive disease or death due to any cause, whichever comes first, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis.|||Percentage of Participants (%)||95% Confidence Interval|Number
1226151|NCT00695396|Secondary|Transfusion Dependent|Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period.|Approximately 48 weeks|The intent-to-treat (ITT) population.|||participants|||Number
1226152|NCT00695396|Secondary|RBC Transfusion From Day 29 Through the End of Study|incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks).|Day 29 through the end of study (approximately 48 weeks)|The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment.|||participants|||Number
1226153|NCT00695396|Primary|Red Blood Cell (RBC) Transfusion|Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study)|Approximately 48 weeks|The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment.|||participants|||Number
1226154|NCT00695318|Primary|Change From Baseline in Size of Geographic Atrophy||24 months|Patients received either a 0.2µg/Day or 0.5 µg/Day treatment in the study eye and a sham treatment in the fellow eye.|||mm3/year||Standard Deviation|Mean
1226155|NCT00695292|Secondary|Efficacy and Safety Analysis Will be Conducted in Patients With Progressive Disease or Irreversible Toxicity on Chemotherapy Alone Who Elect to Receive Sunitinib Alone Until Progressive Disease or Irreversible Toxicity.||18 months|||||||
1226156|NCT00695292|Secondary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Objective benefit is defined as substantial (30% or greater) shrinkage in tumor volume per RECIST 1.0.|18 months|The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.|||percentage of participants||95% Confidence Interval|Number
1226157|NCT00695292|Primary|One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment||18 months|The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.|||percentage of participants|||Number
1226158|NCT00695188|Secondary|HAQ (Health Assessment Questionnaire)||16 weeks|||||||
1226159|NCT00695188|Primary|DAS-28 (Disease Activity Score in 28 Joints)|"DAS stands for Disease Activity Score and is a measure of the activity of rheumatoid arthritis. In Europe the DAS is the recognized standard in research and clinical practice.~The following parameters are included in the calculation:~Number of joints tender to the touch (TEN)~Number of swollen joints (SW)~Erythrocyte sedimentation rate (ESR)~Patient assessment of disease activity (VAS; mm)~The DAS-28 is evaluated using a scale:~0 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity > 5.1: severe disease activity"|16 weeks||||Units on a Scale||Standard Deviation|Mean
1226160|NCT00695136|Primary|Change in Percentage of Time That Subjects With Autism Spend in REM Sleep.||1 month (from baseline to 1.25 mg dose)||||percentage of REM sleep||Standard Error|Mean
1226161|NCT00695097|Primary|Change in Biopsy Cell Densities From Baseline to Follow-up|Follow-up biopsy was done 3-6 months after study treatment. Study follow-up monthly for 1 year.|1 year|5 Rituximab participants and 4 Control participants provided both baseline and follow-up biopsies for analysis. 6 participants withdrew their consent.|||cells/mm^3||Standard Deviation|Mean
1226162|NCT00695019|Post-Hoc|Normalization of Platelets|Percentage of participants with a low platelet count at baseline who had a normal platelet count at the end of the study|48 weeks|Participants with a baseline platelet count below 150 who were evaluable for response at week 48 were included in the analysis|||percentage of participants|||Number
1226163|NCT00695019|Secondary|Change in Fibrotest Score|Change in fibrotest score from baseline to week 48|48 weeks||||units on a scale||Standard Deviation|Mean
1226164|NCT00695019|Secondary|Change in Social Functioning|"Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48~Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities."|48 weeks|Intent-to-treat|||change in score||Standard Deviation|Mean
1226165|NCT00695019|Primary|Relapse Rate|"Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation~Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml."|48 weeks|Intent-to-treat|||percentage of participants|||Number
1226166|NCT00695019|Secondary|Change in Serum ALT|Change in Serum ALT concentration from baseline to week 48|48 weeks|Intent-to-treat|||U/L||Standard Deviation|Mean
1226167|NCT00695019|Secondary|Change in Serum HCV RNA Concentration|Change in serum HCV RNA concentration (log10 IU) from baseline to week 48|48 weeks|Intent-to-treat population|||log10 IU||Standard Deviation|Log Mean
1226168|NCT00695019|Secondary|Normalization of ALT|Percentage of participants with a normal serum ALT level at the end of the study|48 weeks|Intent-to-treat|||percentage of participants|||Number
1226175|NCT00694551|Secondary|Number of Participants With Prostatic Specific Antigen (PSA) Doubling|"Number of Participants Who Had a Doubling of the PSA or Proceeded to Another Therapy.~Assess the impact of the vaccine on the pattern of PSA change in patients with castrate testosterone level and in patients with non-suppressed testosterone level not on hormone therapy."|Up to 48 months|29 patients who had serial PSA data, normalized by date and PSA.|||participants|||Number
1226176|NCT00694551|Primary|Occurrence of Related Adverse Events - Grade 3 or Higher|Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.|Up to 48 months|All participants who received treatment.|||participants|||Number
1226177|NCT00694473|Secondary|Navigator CGM Accuracy by Category|Mean Absolute Relative Difference (MARD) between the Navigator CGM and reference blood glucose values by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)|72 hours|MARD by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)|||percent absolute relative difference||Standard Deviation|Mean
1226178|NCT00694473|Secondary|Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing:|"Percentage of readings in different blood sugar ranges as shown by point of care testing:~< 60 mg/dl 61-120 mg/dl 121-180 mg/dl 181-240 lmg/dl >240 mg/dl"|72 hours||||percentage of readings|||Number
1226179|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Projected High Blood Sugar Alarm Criteria Calculated for Events Defined by a High Reference BG Value (> 250 mg/dl)||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia||||||
1226180|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Projected Low Blood Sugar Alarm Criteria Calculated for Events Defined by a Low Reference BG Value (< 60 mg/dL)||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity.||||||
1226181|NCT00694473|Secondary|Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values|Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values|72 hours||||percent absolute relative difference||Full Range|Mean
1226182|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl).||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia||||||
1226183|NCT00694473|Primary|Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl).||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity.||||||
1226184|NCT00694369|Secondary|Patient’s Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication|Patient’s Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient’s rating of the study medication for pain.|At 24 hours post the initial Day 1 dose of the study medication|Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose.|||Participants|||Number
1226185|NCT00694369|Primary|Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)|TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.|Over the first 6 hours post the initial Day 1 dose of the study medication|Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue.|||Units on a Scale||Standard Error|Least Squares Mean
1226186|NCT00694356|Secondary|Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab|Formation of HAHAs may block efficacy by substantially increasing the clearance of dalotuzumab and limit the possibility of future dalotuzumab therapy. The occurrence of HAHAs in the sera of dalotuzumab treated participants at any of the serum collection times was assessed.|Cycle 1: predose on Days 1, 8, 15, and 22; Cycles 2 and 3: predose on Day 1; 4 weeks after last dose of study drug|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1226187|NCT00694356|Secondary|Steady State Volume of Distribution (Vss) of Dalotuzumab|Vss was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
1226188|NCT00694356|Secondary|Clearance (CL) of Dalotuzumab|CL of dalotuzumab was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||mL/min/kg||Geometric Coefficient of Variation|Geometric Mean
1226189|NCT00694356|Secondary|Apparent Terminal Half-life (t1/2) of Dalotuzumab|t1/2 was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||h||Geometric Coefficient of Variation|Geometric Mean
1226508|NCT00690898|Secondary|Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels||Week 12, 24, and 48|Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population.|||percentage change||95% Confidence Interval|Mean
1226190|NCT00694356|Secondary|Time to Cmax (Tmax) of Dalotuzumab|Tmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||h||Full Range|Median
1226191|NCT00694356|Secondary|Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab|AUC0-∞ was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1226192|NCT00694356|Secondary|Maximum Plasma Concentration (Cmax) of Dalotuzumab|Cmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had pharmacokinetic (PK) measurements at Baseline and at least once during treatment.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1226193|NCT00694356|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.|Up to 71 days|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1226194|NCT00694356|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.|Up to 30 days after last dose of study treatment (Up to 101 days)|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1226195|NCT00694356|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. DLTs were defined as the occurrence of any of the following events when judged to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except alopecia and inadequately treated diarrhea, nausea and vomiting. The number of participants who experienced a DLT is presented.|Cycle 1 (Up to 4 weeks)|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1226196|NCT00694304|Secondary|Change From Baseline in SDS Total Score After 52 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
1226197|NCT00694304|Secondary|Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment||Baseline and Week 52|FAS; OC|||percentage of patients|||Number
1226198|NCT00694304|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC; Baseline from lead-in study NCT00635219 / 11984A|||percentage of patients||Standard Deviation|Mean
1226199|NCT00694304|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC; Baseline from lead-in study NCT00635219 / 11984A|||percentage of patients||Standard Deviation|Mean
1226200|NCT00694304|Secondary|Change From Baseline in CGI-S Score After 52 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
1226201|NCT00694304|Secondary|Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
1226202|NCT00694304|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
1226203|NCT00694304|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)|||units on a scale||Standard Deviation|Mean
1226206|NCT00694161|Other Pre-specified|Change From Baseline in 6-Minute Walk Test (6MWT) at Month 3, 6 and 12|6MWT was used to assess the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.. The distance walked in 6 minutes was categorized as: Level 1: <300 meter, Level 2: 300-374.9 meter, Level 3: 375-449.9 meter, Level 4: >=450 meter.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||meters||Standard Deviation|Mean
1226207|NCT00694161|Other Pre-specified|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide(NT-proBNP) Levels at Week 2, 6, Month 3, 6 and 12|NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.|||picogram/mL (pg/mL)||Standard Deviation|Mean
1226208|NCT00694161|Other Pre-specified|Change From Baseline in Troponin I and Troponin T at Week 2, 6, Month 3, 6 and 12|Troponin I and troponin T were the cardiac markers. Troponin I and troponin T were part of the troponin complex, where troponin I was bound to actin in thin myofilaments and troponin T was bound to tropomyosin. Higher level of these markers was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1226209|NCT00694161|Other Pre-specified|Change From Baseline in the Short Form 36 (SF-36) at Month 3, 6 and 12|SF-36 was standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Scores for the 8 domains range from 0-100, where higher scores were better (100=highest level of functioning) and reported as 2 summary scores; Mental Component Score (MCS) and Physical Component Score (PCS). The score for a section was an average of the individual question scores, which were scaled 0-100, where higher scores were better.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints. Data was collected at Month 3 but not statistically summarized as planned.|||Units on a scale||Standard Deviation|Mean
1226210|NCT00694161|Other Pre-specified|Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at Month 3, 6 and 12|KCCQ was a 23-item heart failure specific questionnaire quantified in to following 10 summary scores: physical limitation, symptom frequency, symptom severity, and symptom stability, total symptoms, quality of life, social interference, self-efficacy, overall summary and clinical summary. Total score ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life. Summary scores were scaled to range from 0 to 100, with higher scores representing greater disability.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Units on a scale||Standard Deviation|Mean
1226211|NCT00694161|Other Pre-specified|Number of Participants With Change in Patient Global Assessment (PtGA) at Month 3, 6 and 12|"Participant’s overall quality of life was measured by the PtGA. At baseline participants answered to question: in general, how do you feel today? - on a 5-point scale from '1' (excellent) to '5' (poor). At each follow-up visit, participant’s answered to question: “How do you feel today as compared to when we talked with you at your last clinic visit for this study?” on a 7-point scale- '1' markedly improved, '2' moderately improved, '3' mildly improved, '4' unchanged, '5' mildly worsened, '6' moderately worsened, '7' markedly worsened."|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Participants|||Number
1226212|NCT00694161|Other Pre-specified|Number of Participants With Increased Interstitial Markings and Pleural Effusions|Chest x-ray was done to record the presence of increased interstitial markings (a large number of interstitial markings was indicative of abnormality in the lung) and pleural effusion, which was defined as accumulation of fluid between the layers of tissue that line the lungs and chest cavity.|Baseline, Month 6, Month 12|Intent to Treat (ITT) population included all participants who received at least one dose of study medication.|||Participants|||Number
1226213|NCT00694161|Other Pre-specified|Cardiothoracic (CT) Ratio|Cardiothoracic ratio was defined as the transverse diameter of the heart, compared with that of the thoracic cage, used to help determine enlargement of the heart.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication.|||Ratio||Standard Deviation|Mean
1226214|NCT00694161|Other Pre-specified|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Week 6, Month 3, 6 and 12|NYHA: classified as ‘class I’ (participants with cardiac disease but without resulting limitations of physical activity), ‘class II’ (participants with cardiac disease resulting in slight limitation of physical activity), ‘class III’ (participants with cardiac disease resulting in marked limitation of physical activity), ‘class IV’ (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as ‘improved' (positive change), ‘no change’ or ‘worsened' (negative change).|Baseline, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Data at Week 6 was collected but was not summarized due to a change in the planned analysis. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Participants|||Number
1226312|NCT00693420|Other Pre-specified|Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)|"Overall, how satisfied are you with your eyelashes? Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)"|Baseline to Week 20|Intent to Treat Population|||score on a scale||Standard Deviation|Mean
1226215|NCT00694161|Other Pre-specified|Heart Rate Variability- Percentage of Successive R-R Intervals With Greater Than 50 Msec Difference Between Normal Beats (pNN50)|Holter monitor was a machine that recorded the heart rhythms. The term ‘NN’ was used in place of ‘R-R’ when the processed beats are normal beats. The percentage of successive R-R intervals with greater than 50 msec difference between normal beats was derived by dividing NN50 by the total number of NN intervals (pNN50), where NN50 was the number of interval differences of successive NN intervals greater than 50 msec.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Percentage of intervals||Standard Deviation|Mean
1226216|NCT00694161|Other Pre-specified|Heart Rate Variability (HRV)- Standard Deviation (SD) Parameters|Holter monitor was a machine that recorded the heart rhythms. HRV time-domain indices were summarized for root-mean-square of successive differences [RMS SD] of the R-R intervals (R-R is the interval between successive Rs in the ECG wave) between normal beats (NN), magid standard deviation (Magid SD) of normal to normal R-R intervals and Kleiger standard deviation of normal to normal R-R intervals (Kleiger SD). The term ‘NN’ is used in place of ‘R-R’ when the processed beats are normal beats.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||msec||Standard Deviation|Mean
1226217|NCT00694161|Other Pre-specified|Number of Participants With Complete Heart Block|Complete heart block is the third-degree atrioventricular block in which the impulse generated in the sinoatrial node in the atrium does not propagate to the ventricles.|Baseline, Month 6, Month 12|No summary was prepared for this data as there were no reports of complete heart block.||||||
1226218|NCT00694161|Other Pre-specified|24-Hour Average Heart Rate and Maximium/Minimum Heart Rate|Holter monitor was a machine that recorded the heart rhythms. 24-hour average heart rate and maximium/minimum heart rate was recorded using Holter monitoring.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||beats per minute (bpm)||Standard Deviation|Mean
1226219|NCT00694161|Other Pre-specified|Number of Participants With Atrial Fibrillation/Flutter, Atrial Tachycardia, Non-Sustained Ventricular Tachycardia (NSVT) Beats), Sustained Ventricular Tachycardia (SVT), Sinus Pause at Month 6 and 12|Holter monitor was a machine that recorded the heart rhythms. Holter monitoring abnormalities of atrial fibrillation/flutter (rapid, irregular heart rhythm), atrial tachycardia (rapid cardiac rate), non-sustained ventricular tachycardia (NSVT)<30 beats, sustained ventricular tachycardia (SVT) >=30 beats and sinus pause (transient interruption in the sinus rhythm) were recorded.|Baseline, Month 6, Month 12|ITT population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal(that is treatment-emergent abnormalities).|||Participants|||Number
1226220|NCT00694161|Other Pre-specified|Change From Baseline in 4 Chamber Left Atrial Dimension and 4 Chamber Right Atrial Dimension at Month 6 and 12|Cardiac MRI was done to measure the left and right atrial dimensions which have diagnostic and prognostic significance in cardiology, in the 4 chamber view.|Baseline, Month 6, Month 12|Data for this measure was not collected due to a change in the planned analysis.||||||
1226221|NCT00694161|Other Pre-specified|Change From Baseline in 4 Chamber Interatrial Septal Thickness at Month 6 and 12|Cardiac MRI was done to measure interatrial septal thickness in the 4 chamber view.|Baseline, Month 6, Month 12|Data for this measure was not collected due to a change in the planned analysis.||||||
1226222|NCT00694161|Other Pre-specified|Change From Baseline in Percentage of Left Ventricular Myocardial Mass With Amyloidosis and Left Ventricular Myocardial Mass With Fibrosis/Scar at Month 6 and 12|Cardiac MRI was done to measure percentage of LV myocardial mass with amyloidosis and LV myocardial mass with fibrosis/scar. LV myocardial mass with amyloidosis or fibrosis/scar was calculated from the product of the myocardial volume and specific gravity of heart muscle, in participants with amyloidosis or fibrosis/scar, respectively.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Percentage of LVM||Standard Deviation|Mean
1226223|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Cardiac Output and Right Ventricular Cardiac Output at Month 6 and 12|Cardiac MRI was done to measure cardiac output, which was the volume of blood being pumped by the heart, in particular by the left or right ventricle in the time interval of one minute.|Baseline, Month 6, Month 12|MRI data was collected and reported for cardiac output through the measure of stroke volume as given in outcome measure 17.||||||
1226224|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Ejection Fraction and Right Ventricular Ejection Fraction at Month 6 and 12|Cardiac MRI was done to measure: left ventricular ejection fraction (LVEF) was the fraction of the EDV that is ejected out of left ventricle with each contraction and right ventricular ejection fraction (RVEF) was the fraction of the EDV that is ejected out of right ventricle with each contraction. EDV is the volume of blood within a ventricle immediately before a contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Percentage of EDV||Standard Deviation|Mean
1226270|NCT00694096|Primary|Proliferative Response|Number of patients achieving proliferative response (at least Partial Response) assessed with follow-up FLT-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average SUVmax relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.|4 weeks|Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.|||participants|||Number
1226225|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricle End Diastolic Volume, Left Ventricle End Systolic Volume, Left Ventricle Stroke Volume, Right Ventricle End Diastolic Volume, Right Ventricle End Systolic Volume, Right Ventricle Stroke Volume at Month 6 and 12.|Cardiac MRI was done to measure left ventricle end diastolic volume (LVEDV), left ventricle end systolic volume (LVESV), left ventricle stroke volume (LVSV), right ventricle end diastolic volume (RVEDV), right ventricle end systolic volume (RVESV) and right ventricle stroke volume (RVSV).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||mL||Standard Deviation|Mean
1226226|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Mass, Mass of Left Ventricular Myocardium With Amyloidosis, Mass of Left Ventricular Myocardium With Fibrosis/Scar and Right Ventricular End Diastolic Mass at Month 6 and 12|Cardiac MRI was done to measure LVM, mass of left ventricular (LV) myocardium with amyloidosis, mass of LV myocardium with fibrosis/scar and right ventricular end diastolic mass (RVEDM).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Gram||Standard Deviation|Mean
1226227|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Anteroseptal, Left Ventricular Inferolateral Wall Thickness and Right Ventricular End Diastolic Free Wall Thickness at Month 6 and 12|Cardiac Magnetic Resonance Imaging (MRI) was done to measure the thickness of left ventricular anteroseptal (LVAS) wall, left ventricular inferolateral (LVIL) wall and right ventricular end diastolic free (RVEDF) wall.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||mm||Standard Deviation|Mean
1226228|NCT00694161|Other Pre-specified|Number of Participants With Change From Baseline in Valvular Abnormalities at Month 6 and 12|Valvular abnormalities were those abnormalities (thickening or regurgitation) that involved one or more valves of the heart, determined by echocardiography.|Baseline, Month 6, Month 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1226229|NCT00694161|Other Pre-specified|Change From Baseline in Pericardial Effusion at Month 6 and 12|Pericardial effusion was the presence of an abnormal amount of fluid in the pericardial cavity, as determined by echocardiography.|Baseline, Month 6, Month 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1226230|NCT00694161|Other Pre-specified|Change From Baseline in Tissue Doppler- Septal and Lateral Velocity at Month 6 and 12|Tissue Doppler used doppler principles to measure the annular velocities at the lateral and septal areas of the mitral annulus. s’: systolic velocity during ejection, e’: early diastolic mitral annular velocity, a’: late diastolic mitral annular velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific categories.|||centimeter/second (cm/sec)||Standard Deviation|Mean
1226231|NCT00694161|Other Pre-specified|Change From Baseline in Doppler Data: Mitral Deceleration Time at Month 6 and 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. The mitral deceleration time was the time taken from the maximum E wave to baseline. E wave arises due to early diastolic filling.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||msec||Standard Deviation|Mean
1226232|NCT00694161|Other Pre-specified|Change From Baseline in Doppler Data: E/A and E/e' Ratio at Month 6 and 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Ratio of early (E) diastolic transmitral flow velocity and atrial (A) contraction velocity (E/A) and ratio of the early (E) diastolic transmitral flow velocity to the mitral annular velocity (e’) (E/e') were estimated.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Ratio||Standard Deviation|Mean
1226233|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Ejection Fraction at Month 6 and 12|Left ventricular ejection fraction (LVEF) was the fraction of the end-diastolic volume (EDV) that is ejected out of left ventricle with each contraction, estimated by echocardiography. EDV is the volume of blood within a ventricle immediately before a contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Percentage of EDV||Standard Deviation|Mean
1226234|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Mass (LVM) at Month 6 and 12|LVM was defined as increase in the mass of left ventricle, estimated by echocardiography. Increased LVM was associated with cardiovascular morbidity and mortality.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Gram||Standard Deviation|Mean
1226286|NCT00693719|Secondary|Overall Survival|Still alive for a certain period of time after they were diagnosed with or started treatment|Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months||||Days||95% Confidence Interval|Median
1226569|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
1226235|NCT00694161|Other Pre-specified|Change From Baseline in Echocardiographic (ECHO) Parameters at Month 6 and 12|Echocardiography was used to measure interventricular septal thickness (IVST), posterior left ventricular wall thickness (PLVWT), right ventricular wall thickness (RVWT), left atrial diameter (LAD): anterior-posterior (ant-post), medio-lateral, superior-inferior (sup-inf) and left ventricular end diastolic diameter (LVEDD).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||millimeter (mm)||Standard Deviation|Mean
1226236|NCT00694161|Other Pre-specified|Number of Participants Discontinuing From The Study Due to Clinically Significant Clinical or Laboratory Adverse Events (AEs)||Baseline up to Month 12|ITT population included all participants who received at least one dose of study medication.|||Participants|||Number
1226237|NCT00694161|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings|ECHO:investigator assessed test to assess cardiac function.ECHO abnormality criteria:any/valvular abnormality,pericardial effusion,abnormal regional wall motion,inferior vena cava respiratory variation,posterior left ventricular wall/septal thickness>=13 millimeter(mm),right ventricular thickness>=7mm,ejection fraction <50%, ratio of early (E) diastolic transmitral flow and atrial(A) contraction velocity (E/A)>=2, ratio of ‘E’to lateral/septal mitral annular velocity (e’) (E/e’prime lateral>15, E/e’prime septal>15), E deceleration time<=150 millisecond(msec),Isovolumic relaxation time<=70msec.|Baseline up to Month 12|ITT population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal(that is treatment-emergent abnormalities).|||Participants|||Number
1226238|NCT00694161|Other Pre-specified|Number of Participants With Greater Than or Equal to (>=) Grade 3 Treatment-Emergent AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. On the basis of intensity, grade 3 was referred as severe, grade 4 as life-threatening and grade 5 as death.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least one dose of study medication.|||Participants|||Number
1226239|NCT00694161|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least one dose of study medication.|||Participants|||Number
1226240|NCT00694161|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Month 6 and 12|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1226241|NCT00694161|Primary|Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Week 6|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 6|Intent-to-Treat (ITT) population included all participants who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1226242|NCT00694122|Primary|Blood Glucose|Average value of repeatedly measured absolute values beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on NPH insulin as the long acting insulin; the other overnight was glargine(Lantus) insulin as the the long acting insulin.|Overnight|All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.|||mmol/l||Standard Deviation|Mean
1226243|NCT00694122|Secondary|Growth Hormone|Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.|||ug/l||Standard Deviation|Mean
1226244|NCT00694122|Secondary|Glucagon|Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.|||mcg/l||Standard Deviation|Mean
1226245|NCT00694122|Secondary|Cortisol|Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.|||nmol/l||Standard Deviation|Mean
1226246|NCT00694122|Secondary|Insulin Dose|NPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours.|Overnight||||units||Standard Deviation|Mean
1226247|NCT00694122|Primary|Blood Glucose Area Under the Curve (AUC)|Cumulative sum of repeatedly measured blood glucose values (mg/dl) beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on neutral protamine Hagedorn (NPH) insulin as the long acting insulin; the other overnight was glargine (Lantus) insulin as the the long acting insulin.|Overnight|All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.|||mg*10hr/dL||Standard Deviation|Mean
1226313|NCT00693420|Secondary|Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)|Baseline to Week 20|Intent to Treat Population|||intensity unit||Standard Deviation|Mean
1226248|NCT00694109|Secondary|Percent Change From Baseline in Apolipoprotein A-1|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
1226249|NCT00694109|Secondary|Change From Baseline in C-Reactive Protein|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
1226250|NCT00694109|Secondary|Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Total VLDL Particles' Size and Chylomicron Particles' Size.|||percent change||95% Confidence Interval|Mean
1226251|NCT00694109|Secondary|Percent Change From Baseline in VLDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Small).|||percent change||95% Confidence Interval|Mean
1226252|NCT00694109|Secondary|Percent Change From Baseline in VLDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Medium).|||percent change||95% Confidence Interval|Mean
1226253|NCT00694109|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size.|||percent change||95% Confidence Interval|Mean
1226254|NCT00694109|Secondary|Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Intermediate Density Lipoprotein Particles' Size.|||percent change||95% Confidence Interval|Mean
1226314|NCT00693420|Secondary|Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)|Baseline to Week 16|Intent to Treat Population|||intensity unit||Standard Deviation|Mean
1226255|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Small).|||percent change||95% Confidence Interval|Mean
1226256|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Medium).|||percent change||95% Confidence Interval|Mean
1226257|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Large)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).|||percent change||95% Confidence Interval|Mean
1226258|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Very Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Very Small).|||percent change||95% Confidence Interval|Mean
1226259|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Small).|||percent change||95% Confidence Interval|Mean
1226260|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Medium).|||percent change||95% Confidence Interval|Mean
1226261|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Large)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).|||percent change||95% Confidence Interval|Mean
1226570|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
1226262|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Total)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Total).|||percent change||95% Confidence Interval|Mean
1226263|NCT00694109|Secondary|Percent Change From Baseline in Lipoprotein (a)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
1226264|NCT00694109|Secondary|Percent Change From Baseline in Triglycerides|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
1226265|NCT00694109|Primary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
1226266|NCT00694109|Primary|Percent Change From Baseline in Total Cholesterol|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
1226267|NCT00694109|Primary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
1226268|NCT00694109|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
1226269|NCT00694096|Secondary|Overall Survival|The length of time from the start of treatment for a disease that patients are still alive; no time limit was imposed on data collection|2399 days|All patients that received study treatment and PET scans at baseline and follow-up|||days||Full Range|Median
1226287|NCT00693719|Primary|Median Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months||||Days||Standard Error|Median
1226271|NCT00694096|Primary|Metabolic Response|Number of patients achieving metabolic response (at least Partial Response) assessed with follow-up FDG-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average maximum standardized uptake value (SUVmax) relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.|4 weeks|Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.|||participants|||Number
1226272|NCT00694070|Primary|Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)|Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.|1-2 hours||||participants|||Number
1226273|NCT00694070|Primary|Number of Participants Rated as <= 3 (Success in Using the Program)|"Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:~successful~successful after being referred to user instructions~success with assistance (similar to a customer call)~unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3."|1-2 hours||||Participants|||Number
1226274|NCT00694070|Primary|Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)|"After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.~Very Simple~Simple~Neither simple nor difficult~Difficult~Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3."|1-2 hours|per protocol|||Participants|||Number
1226275|NCT00694018|Primary|The Roland Morris Disability Questionnaire (RDQ) Score|The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability|12 months|The number of participants analyzed is slightly lower than the number who completed the study at 12 months due to item non-response on the final study survey|||units on a scale||Standard Deviation|Mean
1226276|NCT00693992|Other Pre-specified|VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS||Up to 6 weeks|||||||
1226277|NCT00693992|Secondary|Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.|Duration of study (up to 5 years)|189 participants were evaluable for adverse events.|||percentage of participants|||Number
1226278|NCT00693992|Secondary|Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale|The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.|At 3 months|Patients who completed the EORTC LC13 Dyspnea Subscale at baseline and 3 months were included in this analysis.|||percentage of patients|||Number
1226279|NCT00693992|Secondary|Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale|The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.|At 3 months|Patients who completed the EORTC-QLQ-C30 Global Health Subscale at baseline and 3 months were included in this analysis.|||percentage of patients|||Number
1226280|NCT00693992|Secondary|Response Rate (RR)|"The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Duration of treatment (up to 5 years)||||percentage of participants|||Number
1226281|NCT00693992|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 5 years)||||months||95% Confidence Interval|Median
1226282|NCT00693992|Primary|Progression Free Survival (PFS)|Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.|Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)||||months||95% Confidence Interval|Median
1226283|NCT00693784|Secondary|Roland-Morris Disability Questionnaire|24-item questionnaire with score determined by the number of items checked by the subject. Items assess the effect of back pain on limitations of normal daily activities. Best value = 0 (least disability). Worst value = 24 (most disability). Higher number indicate greater disability.|Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks|n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks|||Units on a scale||Standard Deviation|Mean
1226284|NCT00693784|Secondary|Visual Analog Scale for Low-back Pain|"100 mm line anchored on the left with the descriptor No pain (best value = 0 mm) and anchored on the right with the descriptor Worst possible pain (worst value = 100 mm). Lower scores indicate less pain."|Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks|n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks|||mm||Standard Deviation|Mean
1226285|NCT00693784|Primary|Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail)|The primary outcome for this safety study includes the number and types of adverse events reported in the study. The data fields in this section do not allow for reporting all aspects of this outcome (i.e., the number of adverse events, as well as the types of event). These numbers were entered and are reported in the adverse event section of the Results.|104 weeks|All 15 participants available through 26-week primary endpoint. One voluntary withdrawal and 1 lost-to-follow-up between 26-week follow-up and 52-week extended follow-up. One additional voluntary withdrawal and 1 additional lost-to-follow-up between 52-week extended follow-up and 104-week extended follow-up.|||Events|||Number
1226301|NCT00693628|Primary|Reduction in Time to Healing|time to healing in each group|1 year|study was closed due to low enrollment. Data were not collected.||||||
1226288|NCT00693706|Primary|Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.|GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold rise||95% Confidence Interval|Geometric Mean
1226289|NCT00693706|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1226290|NCT00693706|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1226291|NCT00693706|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1226292|NCT00693706|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1226293|NCT00693706|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 90-day (Days 0-89) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1226294|NCT00693706|Primary|Number of Subjects With New Onset of Chronic Diseases (NOCDs).|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1226295|NCT00693706|Primary|Number of Subjects With Medically Attended Adverse Events (MAEs).|Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1226296|NCT00693706|Primary|Number of Subjects With Solicited General Symptoms.|Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).|||subjects|||Number
1226297|NCT00693706|Primary|Number of Subjects With Solicited Local Symptoms.|Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).|||subjects|||Number
1226298|NCT00693693|Primary|Adherence to Locoid|Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied|2 weeks||||percentage of days||Standard Deviation|Mean
1226299|NCT00693654|Secondary|VAS of Pruritus|Subject's self assessment of itching based on a 100 mm visual analog scale with 0 being no itching and 10 being most severe itching|Assessed at baseline and 4 weeks, week 4 reported||||units on a scale||Standard Deviation|Mean
1226300|NCT00693654|Primary|Investigator Global Assessment|"Investigator’s Global Assessment Disease Severity is based on the following scale:~0 = completely clear: except for possible residual hyper pigmentation~= almost clear: very significant clearance (about 90%)~= Marked improvement: significant improvement (about 75%)~= Moderate improvement: intermediate between slight and marked; representing about 50% improvements~= Slight improvement: some improvement (about 25%); however, significant disease remaining~= No change (moderate to severe disease)~= Worse"|Disease severity assessed at baseline and 4 weeks, week 4 reported||||units on a scale||Standard Deviation|Mean
1226303|NCT00693498|Primary|12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio|plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.|12 hours post-cardiopulmonary bypass|Only data from those subjects receiving transfusions was analyzed as the study intervention was the type of red blood cell and platelet transfusion (washed v. unwashed).|||ratio||Standard Error|Median
1226304|NCT00693485|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 6|Safety Population: all patients who received 1 dose of study medication or sham treatment|||Number of Letters Read Correctly||Standard Deviation|Mean
1226305|NCT00693485|Primary|Percentage of Patients With a Visual Field Improvement in the Study Eye|Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.|Baseline, Month 6|Safety Population: all patients who received 1 dose of study medication or sham treatment|||Percentage of Patients|||Number
1226306|NCT00693472|Secondary|Part 2: PANSS Total Score at Day 14|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item).|Day 14 of Part 2|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.|||Score on a scale||Standard Deviation|Mean
1226307|NCT00693472|Secondary|Part 2: Mean GCI at Day 14|The GCI was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).|Day 14 of Part 2|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.|||Score on a scale||Standard Deviation|Mean
1226308|NCT00693472|Secondary|Part 1: Mean Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score at Day 14|"The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal).~For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item)."|Day 14 of Part 1|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.|||Score on a scale||Standard Deviation|Mean
1226309|NCT00693472|Secondary|Part 1: Mean Global Clinical Impression at Day 14|Global clinical impression (GCI) was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).|Day 14 of Part 1|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.|||Score on a scale||Standard Deviation|Mean
1226310|NCT00693472|Primary|Part 2: Number of Participants Who Were Treatment Failures|Incidence of treatment failure is reported as the number of participants who were treatment failures. A treatment failure is defined as the failure to achieve at least a 1 point reduction from baseline in BAS score at 24 to 26 hours following study treatment. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 – 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).|Up to 14 days|Efficacy analysis population was defined as participants who received at least one dose of study drug.|||Participants|||Number
1226311|NCT00693472|Primary|Part 1: Number of Participants With Akathisia|Incidence of akathisia is reported as the number of participants who experienced akathisia. Akathisia is defined as a score of 3 on the Barnes akathisia scale (BAS) for 3 consecutive intervals or an akathisia score (BAS) of ≥4 for any single day, or the use of a rescue medication within 13 days of initiating treatment with haloperidol and preladenant. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 – 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).|Up to 13 days|Efficacy analysis population was defined as participants who received at least one dose of study drug.|||Participants|||Number
1226315|NCT00693420|Secondary|Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.|Baseline to Week 20|Intent to Treat Population|||percentage of AOI (in pixels)||Standard Deviation|Mean
1226316|NCT00693420|Primary|Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)|The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])|Baseline to Week 20|Intent to Treat Population|||Percentage of participants|||Number
1226317|NCT00693420|Other Pre-specified|Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16|"Overall, how satisfied are you with your eyelashes?~Possible Answers on a 5 point scale as follows:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied"|Baseline to Week 16|Intent to Treat Population|||score on a scale||Standard Deviation|Mean
1226318|NCT00693420|Secondary|Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.|Baseline to Week 16|Intent to Treat Population|||percentage of AOI (in pixels)||Standard Deviation|Mean
1226319|NCT00693420|Secondary|Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Upper eyelash length technologically measured in millimeters|Baseline to Week 20|Intent to Treat Population|||millimeters||Standard Deviation|Mean
1226320|NCT00693420|Secondary|Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Upper eyelash length technologically measured in millimeters|Baseline to Week 16|Intent to Treat Population|||millimeters||Standard Deviation|Mean
1226321|NCT00693420|Primary|Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16|The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])|Baseline to Week 16|Intent to Treat Population|||Percentage of participants|||Number
1226322|NCT00693303|Primary|Evaluation Tool of Children's Handwriting|This criterion-referenced tool measures a child's legibility and speed in grades one through six. The child writes letters and words, numerals, performs near point and far point copying, writes to dictation, and composes a sentence.|8 weeks from start of training||||percent of legible letters||Standard Deviation|Mean
1226323|NCT00693238|Secondary|Disease Control||20 years after end of radiation|||||||
1226324|NCT00693238|Primary|Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.||6 months after the end of radiation therapy||||Participants|||Number
1226325|NCT00693225|Secondary|Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|16 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade D. 14 of the 43 participants in the Omeprazole/sodium bicarbonate PM dose arm were LA Grade D.|||percentage of participants|||Number
1226326|NCT00693225|Secondary|Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|25 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C. 29 of the 43 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C.|||percentage of participants|||Number
1226327|NCT00693225|Primary|Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks||||percentage of patients|||Number
1226328|NCT00693160|Secondary|Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration|Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac|2.5 hours|11 Subjects in the Intrathecal Ketorolac group received post study treatment analysis of CSF for PGE2. We were not able to obtain CSF samples in 3 of the subjects post study drug injection.|||picograms per milliliter||Standard Deviation|Mean
1226329|NCT00693160|Primary|Hyperalgesia|Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament|24 hours||||centimeters^2||Standard Deviation|Mean
1226330|NCT00693017|Secondary|Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures|Percentage Change from Baseline in the monthly number of days with myoclonic seizures was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline and up to 16 weeks|||||||
1226372|NCT00692341|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1226331|NCT00693017|Primary|Number of Participants Considered Responders as Assessed During the Maintenance Period|The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)|||||||
1226332|NCT00692913|Secondary|Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase|BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 52|Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1226333|NCT00692913|Secondary|Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio|NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 52|Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1226334|NCT00692913|Secondary|Falls Per Participant|"Number of falls per participant was measured.~The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year.~In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the~SPONSOR and served as a guideline to standardize operational procedures for fall adjudication."|Up to Week 52|Intent-to-Treat (ITT) population included all randomized participants within the treatment group to which they were randomized regardless of whether or not a participant may have dropped out in the base or continued into the extension study.|||Number of Falls||Standard Deviation|Mean
1226335|NCT00692913|Secondary|Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density|Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy.|Baseline and Week 52|The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period.|||Percent Change||95% Confidence Interval|Least Squares Mean
1226336|NCT00692913|Secondary|Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52|"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls."|Week 52|The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period.|||Percentage of Participants|||Number
1226337|NCT00692913|Secondary|Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase|Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 26|Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1226338|NCT00692913|Secondary|Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio|N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 26|Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1226339|NCT00692913|Primary|Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26|"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls."|Week 26|"Full Analysis Set Population (FAS) included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were~assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period."|||Percentage of Participants|||Number
1226348|NCT00692770|Secondary|Time to Recurrence (TTR) by Independent Assessment|"TTR was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment. For subjects who had not recurred at the time of analysis, TTR was censored at their last date of evaluable scan before withdrawal for any other reason than recurrence. NA in the reported data indicates values could not be estimated due to censored data."|From randomization up to 4 years or until disease recurrence whichever came first|FAS included participants who were randomized to study treatments.|||Days||95% Confidence Interval|Median
1226340|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - MET|Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into “high” and “low” groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.|||Days||95% Confidence Interval|Median
1226341|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - AFP|Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into “high” and “low” groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.|||Days||95% Confidence Interval|Median
1226342|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - ANG-2|Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into “high” and “low” groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.|||Days||95% Confidence Interval|Median
1226343|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score|The PWB, FWB, SWB and EWB were summed to form the FACT-G total score. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). FACT-G scores ranged from 0 to 108 and the higher scores represented a better quality of life. The MID for the FACT-G total score was in the range of 6 to 7. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-G score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
1226344|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score|The FACT-HEP is a 45 item, self-administered, multi-dimensional, psychometrically sound questionnaire used extensively in oncology clinical trials. FACT-HEP consisted of five subscales: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The PWB, FWB, SWB and EWB were summed to form the FACTGeneral (FACT-G) total score. The FACT-G and HCS scores were summed to form the FACT-HEP total score. FACT-HEP scores ranged from 0 to 180 and the higher scores represented a better quality of life. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). The minimally important difference (MID) for the FACT-Hep total score was in the range of 8 to 9. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-HEP score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
1226345|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score|The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D VAS is a measure that represents health status as a single value. It is a 20-centimetre vertical graduated visual analogue scale with scores that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). The respondent rated his/her current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the EQ-5D VAS. A 3-digit number (including leading zeros) was read off the scale from the point where the respondent’s line crossed the scale, which was the EQ-5D VAS score. A change of at least 7 points on the VAS was considered as minimally important. The results on the ANCOVA analysis of time-adjusted AUC for the EQ-5D VAS score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
1226346|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score|The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D Index is a descriptive system of the following health dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Subjects were asked to choose any one of the 3 response levels for each dimension: no problems, some problems, and severe problems. The 5 health dimensions were summarized into a single score, the EQ-5D Index score which ranged from -0.59 to 1 with higher scores representing better health states (0=death, 1= perfect health, and -0.59=a health state worse than death). A change of at least 0.10 to 0.12 points was considered a minimally important difference using Eastern Cooperative Oncology Group Performance Status as the anchor. The results on the Analysis of covariance of timeadjusted Area under curve for the EQ-5D index score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
1226347|NCT00692770|Secondary|Overall Survival (OS)|"OS was defined as the time from randomization to date of death due to any cause. OS for subjects alive at the time of analysis was censored at their last date of contact. NA in the reported data indicates values could not be estimated due to censored data."|From randomization of the first subject until 4 years later.|FAS included participants who were randomized to study treatments.|||Days||95% Confidence Interval|Median
1226349|NCT00692770|Primary|Recurrence Free Survival (RFS) by Independent Assessment|Disease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death.|From randomization up to 4 years or until disease recurrence whichever came first|Full analysis set (FAS) included participants who were randomized to study treatments.|||Days||95% Confidence Interval|Median
1226350|NCT00692692|Primary|Post Surgical Infection|Number of participants with post surgical infection|4 weeks||||Participants|||Count of Participants
1226351|NCT00692692|Primary|Patient Satisfaction With the Procedure||one year from time of operation|study was terminated and 1 year follow up was not done||||||
1226352|NCT00692419|Primary|Change in Pain, Sexual Dysfunction, and Depression Symptoms|The primary outcome of this study is the change in symptom scores during the intervention phase of the study|12 months|change in pain score during intervention period. In adjusted models, we used mixed effects linear regression to compare changes in symptom scores between the two study arms over the duration of the intervention, and to compare symptom scores among individual patients across the observation and intervention phases.|||units on a scale||Standard Error|Mean
1226353|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in Cun following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Median
1226354|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in Cun following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
1226355|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in AnG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
1226356|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in AnG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
1226357|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
1226358|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
1226359|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
1226373|NCT00692341|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hours (hrs) post-dose|Pharmacokinetic (PK) concentration population included all participants who were treated and had at least 1 concentration measurement.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1226360|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
1226361|NCT00692341|Secondary|Unbound Maximum Observed Plasma Concentration (Cmaxu)|Cmaxu is the highest measured unbound plasma concentration during the dosing interval.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK concentration population included all participants who were treated and had at least 1 concentration measurement. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1226362|NCT00692341|Secondary|Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1226363|NCT00692341|Secondary|Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]|AUC (0 - ∞)u = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) for unbound drug. It is obtained from AUCu (0 - t) plus AUCu (t - ∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1226364|NCT00692341|Secondary|Unbound Apparent Volume of Distribution (Vzu/F)|Volume of distribution of unbound drug is defined as the theoretical volume in which the total amount of unbound drug would need to be uniformly distributed to produce the desired plasma concentration of unbound drug. Unbound apparent volume of distribution after oral dose (Vzu/F) is influenced by the oral bioavailability.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||L||Geometric Coefficient of Variation|Geometric Mean
1226365|NCT00692341|Secondary|Unbound Apparent Oral Clearance (CLu/F)|Clearance of an unbound drug is a measure of the rate at which an unbound drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Unbound drug clearance is a quantitative measure of the rate at which an unbound drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1226366|NCT00692341|Secondary|Fraction of Unbound Drug (fu)|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1226367|NCT00692341|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the oral bioavailability.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
1226368|NCT00692341|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1226369|NCT00692341|Secondary|Plasma Elimination Half-life (t1/2)|Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||hr||Standard Deviation|Mean
1226370|NCT00692341|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||hr||Full Range|Median
1226371|NCT00692341|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1226374|NCT00692237|Secondary|Ejection Fraction (EF) Defined as the Volume of Blood Ejected With Each Beat Was Measured on Cine-Cardiac Magnetic Resonance (CMR) Images Before and After Three Months Treatment With Sildenafil and Placebo (100 mg/Day).|The volume of blood within a ventricle immediately before a contraction is known as the end-diastolic volume; the volume of blood left in a ventricle at the end of contraction is end-systolic volume. The difference between end-diastolic volume and end-systolic volumes is the volume of blood ejected with each beat. Ejection fraction (Ef) is the fraction of the end-diastolic volume that is ejected with each beat; expressed as percentage of EDV. This is a measure of cardiac performance that can be deteriorated in diabetic cardiomyopathy.|0 and + 3 months|"We included in this analysis all the patients that concluded the study (Sildenafil group = 29; Placebo group = 25).~The 4 randomized patients who discontinued, did not perform the second after-treatment CMR evaluation.~Analysis was per protocol."|||Percentage % of volume (delta)||Standard Deviation|Mean
1226375|NCT00692237|Primary|Left Ventricular Torsion Defined as Change in Ventricular Mid-wall Rotation (°) Measured by Cine-Cardiac Magnetic Resonance (CMR) Imaging With Tagging, Before and After Three Months of Treatment With Sildenafil and Placebo (100 mg/Day).|Diabetic cardiomyopathy and hypertrophy are characterized by an increase in cardiac torsion Normal value of rotation are < 12°; in hypertrophic heart such values can raise up to 20-25°. A reduction in left ventricular wall rotation is a sign of improvement after removal of known causes of hypertrophy (for example after surgical repair of aortic stenosis). Based on previous studies a reduction of 3 degrees (°) is considered clinically significant.|0 and + 3 months|An overall sample size of 32 subjects (16 for each group) would thus have given a 90% power to detect the specified minimum detectable difference (3°) at a 2-sided significance level of 0.01; 59 patients were enrolled: 29 randomized to Sildenafil and 25 randomized to Placebo completed the trial. Analysis was per primary efficacy outcome (LV-q).|||Degree angle (delta)||Standard Deviation|Mean
1226376|NCT00692211|Primary|Colorectal Cancer Screening|Completing fecal blood test within 90 days of enrolling|3 months||||participants|||Number
1226377|NCT00692198|Secondary|Dyspnea|Change in dyspnea is measured by change in the St George's Respiratory Questionnaire (SGRQ) total score, follow-up value minus baseline value. The SGRQ total score ranges from 0 to 100, with higher values indicating worse dyspnea. The change in score, follow-up value minus baseline value, ranges from -100 to +100, with higher values indicating increase in dyspnea.|Baseline to 1 year|Patients with both the baseline and 1 year SGRQ total score are included|||units on a scale||Standard Deviation|Mean
1226378|NCT00692198|Secondary|6-minute Walk Distance|Change in distance walked during 6-minute walk test, follow-up value minus baseline value (feet)|Baseline to 1 year|Change in 6 minute walk distance from baseline to 1 year is analyzed for patients with both baseline and 1 year values|||feet||Standard Deviation|Mean
1226379|NCT00692198|Secondary|Development of Severe Resting Desaturation|Severe resting desaturation is defined as resting room air SpO2 <=88%|Baseline to 1 year|Participants completing the 1 year saturation assessment are analyzed|||Participants|||Count of Participants
1226380|NCT00692198|Secondary|Depression|Depression is measured by the change in the Hospital Anxiety and Depression Scale (HADS) depression score, follow-up value minus baseline value. The HADS depression score ranges from 0 to 21 with higher values indicating greater depression. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating increase in depression|Baseline to 1 year|Patients with both baseline and 1 year values are included|||units on a scale||Standard Deviation|Mean
1226381|NCT00692198|Secondary|Anxiety|Anxiety is measured by the change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, follow-up value minus baseline value. The HADS anxiety score ranges from 0 to 21 with higher values indicating greater anxiety. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating increase in anxiety|Baseline to 1 year|Patients with both the baseline and 1 year values are included; a subset of clinics administered the HADS questionnaire.|||units on a scale||Standard Deviation|Mean
1226382|NCT00692198|Secondary|Sleep Quality|Sleep quality is measured by the change in the Pittsburgh Sleep Quality Index total score, follow-up value minus baseline value. The Pittsburgh Sleep Quality Index total score ranges from 0 to 21 with higher values indicating worse sleep quality. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating worsening in sleep quality.|Baseline to 1 year|Participants with both the baseline and 1 year values are included|||units on a scale||Standard Deviation|Mean
1226383|NCT00692198|Secondary|General Quality of Life|General quality of life is measured by the change in the physical component summary subscale of the SF-36 quality of life questionnaire, follow-up value minus baseline value. The physical component summary subscale score ranges from 0 to 100 with higher values indicating better physical functioning. The change in score, follow-up minus baseline value, ranges from -100 to +100 with higher values indicating improvement in physical functioning.|Baseline to 1 year|Participants with both the baseline and 1 year values are included; the SF-36 was administered at a subset of clinics|||units on a scale||Standard Deviation|Mean
1226384|NCT00692198|Secondary|Disease-specific Quality of Life|Disease-specific quality of life is measured by the change in the St George's Respiratory Questionnaire total score, follow-up value minus baseline value. The total score ranges from 0 to 100 with lower score indicating fewer respiratory symptoms. Change in score, follow-up minus baseline may range from -100 to +100, with lower values indicating improvement in disease-specific quality of life.|Baseline to 1 year|Participants with both the baseline and 1 year values are included|||units on a scale||Standard Deviation|Mean
1226385|NCT00692198|Secondary|Preference-weighted Health-related Quality of Life|Preference-weighted health-related quality of life is measured by change in the Quality of Well-being Scale total daily score, follow-up value minus baseline value. The total daily score ranges from 0 to 1 with higher score indicating more better quality of life. Death is scored 0. Greater change, follow-up minus baseline, indicates improvement in quality of life compared to baseline. Change scores may range from -1 to +1.|Baseline to 1 year|Participants with both the baseline and 1 year values were included|||units on a scale||Standard Deviation|Mean
1226386|NCT00692198|Secondary|COPD Exacerbation|Rate of all COPD exacerbations|Through study completion. Median follow-up was 11.4 months||||COPD exacerbations per 100 person-years|||Number
1226387|NCT00692198|Secondary|Adherence|Adherence is measured by self-reported hours of home oxygen per day|Through study completion. Median follow-up was 18.4 months.|Patients providing at least 1 self-report are included.|||hours per day of supplemental oxygen||Standard Deviation|Mean
1226389|NCT00692198|Secondary|Death|The difference between treatment groups in mortality is assessed with a time-to-event analysis by calculation of the between group hazard ratio for death; the statistical significance of the hazard ratio was determined from the log rank test. The uncertainty in the hazard ratio is expressed in the 95% confidence interval on the hazard ratio.|Through study completion. Median follow-up was 41.5 months.||||Deaths/100 person-years|||Number
1226390|NCT00692198|Primary|Death or Hospitalization, Whichever Occurs First|The primary outcome event is death or hospitalization, whichever occurs first. The difference between treatment groups on the primary outcome was assessed with a time-to-event analysis by calculation of the between group hazard ratio for the primary composite outcome; the statistical significance of the hazard ratio was determined from the log rank test. The uncertainty in the hazard ratio is expressed in the 95% confidence interval on the hazard ratio.|Through study completion. Median follow-up was 18.4 months.||||Composite events/100 person-years|||Number
1226391|NCT00692185|Secondary|Anxiety||Measured at Week 8|||||||
1226392|NCT00692185|Primary|Weight Gain||Measured at Week 8||||lbs||Standard Deviation|Mean
1226393|NCT00692003|Primary|Number of Participants Considered Responders as Assessed During the Maintenance Period|The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease from baseline in Primary Generalised Tonic-Clonic Seizures (PGTCS) frequency of >= 50% (i.e. 28-day PGTC seizure frequency in the period from Week 4 to the Week 16 visit compared to Week -8/-4 to randomization at Week 0). Each participant's response to treatment was assessed on the basis of their seizure diaries. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) through out the titration and maintenance treatment periods until the Early termination Visit at Week 16. Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline (Week -8/-4 to Week 0) and Maintenance Phase (Week 4 to Week 16)|Due to early termination of the study by the Sponsor, no formal analyses were conducted.||||||
1226394|NCT00692003|Secondary|Absolute Change From Baseline in 28-day PGTC Seizure Frequency|Absolute Change from Baseline in 28-day PGTC Seizure Frequency was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline and up to 16 weeks|Due to early termination of the study by the Sponsor, no formal analyses were conducted.||||||
1226395|NCT00691938|Secondary|Rate of Hematologic Improvement.|"-Hematologic improvement (HI). Includes the following categories:~Erythroid response: Hemoglobin increase by ≥ 1.5 g/dL over baseline in which the pretreatment hemoglobin is < 11 g/dL or reduction of RBC transfusions of at least 4 RBC transfusions / 8 wk compared with the pretreatment transfusion number in the previous 8 weeks.~Platelet response. Absolute increase of > 30 x 10^9/L for patients starting with 20 x 10^9/L or increase from < 20 x 10^9/L to > 20 x 109/L and by at least 100%~Neutrophil response. At least 100% increase and an absolute increase > 0.5 x 109/L for patients with pretreatment neutrophils < 1.0 x 109/L)"|Up to 12 months||||percentage of participants|||Number
1226396|NCT00691938|Secondary|Rates of Morphologic Complete Remission With Incomplete Count Recovery (CRi)|Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL).|Up to 12 months||||percentage of participants|||Number
1226397|NCT00691938|Secondary|Overall Survival|Overall survival is defined as the date of first dose of study drug to the date of death from any cause.|Completion of follow-up (median follow-up was 58 months)||||months||Full Range|Median
1226398|NCT00691938|Secondary|Event-free Survival|Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, relapse from CR, or death due to any cause.|Completion of follow-up (median follow-up was 58 months)||||days||95% Confidence Interval|Median
1226399|NCT00691938|Secondary|Progression-free Survival||Completion of follow-up (median follow-up was 58 months)|Data was not collected for this outcome measure. Progression is very hard to define for MDS and AML and including it as a pre-specified secondary outcome measure in the protocol was an oversight.||||||
1226400|NCT00691938|Secondary|Remission Duration|Defined as the first date that all criteria for CR, CRi or HI are fulfilled to the date of treatment failure, relapse from CR, or death due to any cause.|Completion of follow-up (median follow-up was 58 months)|Number of participants analyzed include those participants who met the criteria for CR, CRi, or HI.|||days||Full Range|Median
1226401|NCT00691938|Secondary|Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced|Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.|Up to 13 months after start of treatment||||percentage of participants|||Number
1226402|NCT00691938|Secondary|Time to Response|Time to response is defined as the date of the first dose of study drug to the date that all criteria for CR or CRi are fulfilled.|Up to 12 months|Number of participants analyzed are participants that met the criteria for CR or CRi.|||days||Full Range|Median
1226403|NCT00691938|Secondary|Changes in Quality of Life Scores as Measured by the Function Assessment of Cancer Therapy-Leukemia (FACT-Leu) Version 4|-The FACT-Leu consists of a 27-item compilation of general questions divided into four primary quality of life domains: physical well-being, social/family well being, emotional well-being, and functional well-being along with a 17 item subscale developed specifically for patients with leukemia.|Up to approximately 12 months after start of treatment|Data was not collected for this outcome measure.||||||
1226404|NCT00691938|Secondary|Rate of Cytogenetic Complete Remission (CRc)|Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.|Up to 12 months||||percentage of participants|||Number
1226423|NCT00691704|Primary|Progression Free Survival|Progression free survival (PFS) is defined for all subjects as the time from the date of initiation of treatment to the date of first documentation of relapse, progression, or death due to any cause. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). PFS survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|2 years|Subjects enrolled and able to initiate induction therapy.|||participants|||Number
1226405|NCT00691938|Primary|Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi)|"Morphologic complete remission (CR). A CR designation requires that the patient achieve the morphologic leukemia-free state with less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods or persistence of extramedullary disease. Patients must also have an absolute neutrophil count of more than 1,000/μLand platelets of 100,000/μL.~Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.~Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL)."|Up to 12 months||||percentage of participants|||Number
1226406|NCT00691938|Primary|Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine||Completion of Phase I enrollment for MTD (approximately 26 months)|After enrolling all Phase I patients in Dose Levels 1-5b, the maximum tolerated dose was not determined. The Phase II portion of the study used the 5b dose level.|||mg (level 5b dosing schedule)|||Number
1226407|NCT00691808|Primary|Treatment Compliance|Subjects were considered compliant if they had taken >70% of possible doses of the study drug.|End of study||||Percentage of Participants||Standard Deviation|Mean
1226408|NCT00691808|Primary|Number of Subjects Reporting Adverse Events Leading to Withdrawal||28 days||||Participants|||Number
1226409|NCT00691808|Primary|Number of Subjects Reporting at Least One Adverse Event (AE)|An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.|28 days||||Participants|||Number
1226410|NCT00691808|Secondary|Change From Baseline in Epworth Sleepiness Scale at Day 28|The Epworth Sleepiness Scale is a self-administered questionnaire used to help quantify a subject's level of daytime sleepiness. Subjects recorded their chances of dozing on a scale of 0 to 3, with 0 being no chance and 3 being a high chance. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28||||Units on a scale||Standard Deviation|Mean
1226411|NCT00691808|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index at Day 28|The Pittsburgh Sleep Quality Index is a self-rated questionnaire that assesses sleep quality and disturbances. Responses were scored on a scale of 0 to 3 where 3 is the negative extreme. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28||||Units on a scale||Standard Deviation|Mean
1226412|NCT00691808|Secondary|Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28|The subjects were asked to describe their memory ability in a variety of situations of everyday life (a list of 25 questions) using a 5-point scale, with a lower score being a negative assessment. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28||||Units on a scale||Standard Deviation|Mean
1226413|NCT00691808|Secondary|Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28|Subjects are asked to recall words from the preceding week's 15-Words Test. Baseline (Day -1) scores (scale 0-15, 0 being the worst) were subtracted from Day 28 scores to obtain the score change from baseline.|Day 28||||Number of words||Standard Deviation|Mean
1226414|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||14 to18 days||||Participants|||Number
1226415|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||25 to 27 days||||Participants|||Number
1226416|NCT00691808|Secondary|Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28|The 15-Words Test is used to measure verbal learning and memory. Subjects are scored on the number of recognized words on a scale of 0-15, with 0 being the worst and 15 being the best. The baseline (Day -1) score was subtracted from the Day 28 score to obtain the Score Change from Baseline.|Day 28||||Number of words||Standard Deviation|Mean
1226417|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||≥28 days||||Participants|||Number
1226418|NCT00691808|Secondary|Plasma Concentration||Day 28||||ng/mL||Standard Deviation|Mean
1226419|NCT00691704|Secondary|Duration of Response|The duration of response, defined only among the responders, is measured from start of achieving Partial Response (PR) [first observation of PR before confirmation] to the time of disease progression, with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). Duration of response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 years||||months||Full Range|Mean
1226420|NCT00691704|Secondary|Time to Progression|Time to progression (TTP) is defined for all patients as the time from initiation of treatment to disease progression with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006).|6 years|Subjects who experienced disease progression.|||months||Full Range|Mean
1226421|NCT00691704|Secondary|Overall Survival|Overall survival is defined as the time from the date of initiation of treatment to the date of death due to any cause. Overall response rate will be estimated with its 80% confidence interval, and the numbers of subjects achieving a sustained complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) will be tabulated. Overall survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 years|Subjects who initiated drug therapy. Eleven patients are still alive as of 2/28/14.|||months||Full Range|Mean
1226422|NCT00691704|Secondary|Time to Response|Time to response will be measured in the population of subjects with a confirmed response as the time from the date of initiation of treatment to the date of the first documentation of a confirmed response. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). Time to response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 months|Subjects who responded to drug induction therapy.|||months||Full Range|Mean
1226456|NCT00691132|Secondary|Urinary Levels of [Pyridine-D4]Hydroxy Acid:Total [Pyridine-D4]NNAL Ratio by GSTM1 and GSTT1 Genotype.|% Difference in ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL while on PEITC compared to while on Placebo ((PEITC - Placebo) / PEITC) x 100%|After 5 days of treatment||||percentage of change in ratio||95% Confidence Interval|Geometric Mean
1226424|NCT00691665|Primary|Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.|14 Days minus baseline||||Percent change||Standard Deviation|Mean
1226425|NCT00691665|Primary|Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline|Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.|14 Days minus baseline||||Percent change||Standard Deviation|Mean
1226426|NCT00691665|Primary|Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline||||Percent change||Standard Deviation|Mean
1226427|NCT00691665|Primary|Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline|Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|14 Days minus baseline||||Percent change||Standard Deviation|Mean
1226428|NCT00691652|Secondary|Identity of the Gene Activated by Clofarabine Therapy by Using Genomic DNA and RNA Array Technology||Twice monthly at standard of care visits for 3 months post last cycle of chemotherapy.|||||||
1226429|NCT00691652|Secondary|Whether Response to Clofarabine Alone or in Combination With Rituximab Correlates With Changes in Global Serum DNA Methylation Index||Duration of the study, up to 1 year.|||||||
1226430|NCT00691652|Secondary|Whether Clofarabine Acts as an Inhibitor of DNA Methylation Similar to Cladribine by Performing Scientific Correlates||Duration of the study, up to 1 year.|||||||
1226431|NCT00691652|Secondary|Determine the Safety and Efficacy of Clofarabine in Combination With Rituximab||Duration of the study, up to 1 year.|||||||
1226432|NCT00691652|Secondary|Determine One-year Progression Free Survival Using the MTD of Clofarabine With Rituximab in Relapsed CD20+NHL||One year after study drug(s) have been given. Duration of study up to 1 year.|||||||
1226433|NCT00691652|Primary|Estimate Objective Response Rates of Oral Clofarabine in Combination With Rituximab in Relapsed CD20+NHL||Oral Clofarabine x 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle|||||||
1226434|NCT00691652|Primary|The Maximum Tolerated Dose (MTD) of Oral Clofarabine in Adult Patients With Relapsed CD20+ Non-Hodgkin Lymphoma(NHL)|"Initially, 3 patients will be enrolled into a dose level during the dose-escalation portion:~If no patient experiences dose-limiting toxicities during the first 4 weeks, then 3 patients will be enrolled into the next dose level.~If one of the three patients develops dose-limiting toxicities, then 3 additional patients will be enrolled in that cohort. If none of the additional 3 patients experiences dose-limiting toxicities, then further dose-escalation occurs.~If one additional patient experiences dose-limiting toxicities, then the maximum tolerated dose is exceeded."|14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days||||Number of participants|||Number
1226435|NCT00691483|Other Pre-specified|Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12|Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).|Baseline through Week 5|Number of participants analyzed = participants with FQA through Week 5, excluding 157 participants for whom FTND was not done at the time of FQA (1 participant also had inconsistent FQA date with first dosing date). Analysis done by smoking status at Week 12 (Responder for the primary endpoint of CA Weeks 9-12).|||Units on a scale||Standard Deviation|Mean
1226436|NCT00691483|Secondary|Percentage of Participants With 4-week Point Prevalence of Nonsmoking|Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.|Week 24|"FAS. Missing inventory interview questions of whether the subject had smoked or used any other tobacco products in the last 4 weeks were not imputed. Missing CO was imputed as =<10 ppm."|||Percentage of participants|||Number
1226437|NCT00691483|Secondary|Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)|Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.|Week 12 and Week 24|"FAS. Missing weekly interview questions of whether the subject had smoked in the last 7 days were not imputed; missing CO was imputed as =<10 ppm."|||Percentage of participants|||Number
1226457|NCT00691132|Secondary|Combined Effects of GSTM1 and GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC||After 5 days of treatment||||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
1226438|NCT00691483|Secondary|Percentage of Participants With Long Term Quit Through Week 24|Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.|Week 9 through Week 24|FAS. If the number of days smoked was missing for a subject visit, the CA responder status of the subject at that visit determined the imputation.|||Percentage of participants|||Number
1226439|NCT00691483|Secondary|Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24|Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products ‘since the last visit’ and did not have CO >10 ppm.|Week 9 through Week 24|FAS. Missing CO measurements imputed as =<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions.|||Percentage of participants|||Number
1226440|NCT00691483|Primary|Percentage of Participants With 4-week Continuous Abstinence (CA)|The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products ‘since the last visit’ and did not have CO >10 ppm.|Week 9 through Week 12|Full analysis set (FAS): took at least 1 dose, including partial doses, of randomized study drug. Missing CO measurements imputed as =<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions.|||Percentage of participants|||Number
1226441|NCT00691327|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|5 years|All patients who had a breast implant satisfaction rating|||Units on a scale||Standard Deviation|Mean
1226442|NCT00691327|Primary|Local Complications|By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts|5 years|All enrolled patients|||Percentage by Patient||95% Confidence Interval|Number
1226443|NCT00691301|Secondary|Duration of Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years.|Eligible and treated patients|||months||Full Range|Median
1226444|NCT00691301|Secondary|Progression-free Survival|Duration of progression-free survival in months.|From enrollment onto the study until the onset of disease progression or death, up to 5 years|Individuals who initiated study treatment|||months||Inter-Quartile Range|Median
1226445|NCT00691301|Primary|Frequency and Severity of Observed Adverse Effects|All eligible and evaluable patients|every 21 days during study treatment and up to 30 days after the last cycle of treatment.|All eligible and evaluable patients.|||Participants|||Count of Participants
1226446|NCT00691301|Primary|Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years.|Individuals who initiated study treatment|||participants|||Number
1226447|NCT00691210|Primary|The Maximum Tolerated Dose of Niacinamide in the Combination of Vorinostat and Niacinamide||3 years||||mg/kg|||Number
1226448|NCT00691210|Secondary|Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies||continuous|||||||
1226449|NCT00691210|Secondary|The Prevalence of Anti-tumor Activity||continuous|||||||
1226450|NCT00691210|Secondary|The Number of Dose Delays and Reductions at the MTD||continuous|||||||
1226451|NCT00691210|Secondary|The Greatest Number of Cycles Received in Each Treatment Group|The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.|up to 45 weeks||||cycles|||Number
1226452|NCT00691197|Post-Hoc|Patient Preference|Percentage of patients who used pre-study rewetting drops and answered “Agree” or “Strongly Agree” when asked if they preferred the study drops (SD) over their pre-study drops(PSD).|Day 30|Responders Completed Population|||Percentage of participants|||Number
1226453|NCT00691197|Secondary|Corneal Staining|Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding|Day 90|Completed Population|||Participants|||Number
1226454|NCT00691197|Post-Hoc|Patient Acceptability|"A questionnaire was administered to all patients to evaluate the acceptability of the Rewetting Drops (RD) with use with Contact Lenses (CL). Table below shows the percentage of participants responding either Agree or Strongly Agree at day 90. Number of participants answering question is indicated as (number of Test subjects/number of Control subjects)"|Day 90|Intent to Treat Population|||Percentage of Participants|||Number
1226455|NCT00691197|Primary|Best Corrected Visual Acuity|Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.|Change from Baseline at Day 90|Completed Population|||Percentage of Participants|||Number
1226458|NCT00691132|Secondary|Effects of GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC|Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTT1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.|After 5 days of treatment||||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
1226459|NCT00691132|Secondary|Effects of GSTM1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC|Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTM1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.|After 5 days of PEITC treatment||||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
1226460|NCT00691132|Primary|Urinary Levels of Biomarkers of NNK Metabolism|The ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL will be measured. This ratio is not expected to be influenced by the number of cigarettes smoked per day, or smoking topography.|After 5 days of treatment||||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
1226461|NCT00691132|Primary|Urinary Levels of Biomarkers of NNK Metabolism|Urinary levels of Total ITC and PEITC-NAC by treatment sequence groups and treatment period.|2 periods, 5 days each on PEITC or Placebo, with washout week between||||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
1226462|NCT00691093|Secondary|Reasons for Study Treatment Dose Changes|Possible change in the dose and the reasons for the change were collected and documented.|Month 3 or ET|SAS|||participants|||Number
1226463|NCT00691093|Secondary|Study Doses|Number of subjects that changed doses throughout the study period.|Month 3 or ET|SAS|||participants|||Number
1226464|NCT00691093|Secondary|Time To Onset Of Treatment Response|Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.|Month 1, Month 2, Month 3 or ET|FAS|||weeks||Full Range|Median
1226465|NCT00691093|Secondary|Change From Baseline in Total Scores of OAB-q at Visit 4|Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.|Baseline, Month 3 or ET|FAS|||scores on a scale||Standard Deviation|Mean
1226466|NCT00691093|Primary|Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4|The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or ET|FAS|||episodes||Standard Deviation|Mean
1226467|NCT00691093|Primary|Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4|UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of ‘urgency’ urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).|Baseline, Month 1, Month 2, Month 3 or ET|FAS|||episodes||Standard Deviation|Mean
1226468|NCT00691093|Primary|Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4|Nocturnal frequency: mean number of ‘night time’ (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of ‘night time’ urinations, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or ET|FAS|||episodes||Standard Deviation|Mean
1226469|NCT00691093|Secondary|Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale|Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.|Baseline, Month 3 or ET|FAS|||scores on a scale||Standard Deviation|Mean
1226470|NCT00691093|Secondary|Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4|Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered ‘(2) About the same’ to question 1 then a score of 0 was given. If a subject answered ‘(1) Worse’ to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered ‘(3) Better’ to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.|Month 3 or ET|FAS|||scores on a scale||Standard Deviation|Mean
1226471|NCT00691093|Secondary|Clinical Global Evaluation of Fesoterodine|Clinical global evaluation of study medication was assessed via the question ‘how would you rate the study medication the patient received for overactive bladder?,’ and was assessed on the four point categorical scale, ranging from ‘Poor’ to ‘Excellent.’|12 weeks|SAS|||participants|||Number
1226472|NCT00691093|Secondary|Patient's Global Evaluation of Fesoterodine|The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?’ and was assessed on the four point categorical scale, ranging from ‘Poor’ to ‘Excellent'.|Baseline, Month 3 or ET|The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.|||participants|||Number
1226473|NCT00691093|Secondary|Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4|The PVR urine volume: measured by an ultrasound scan.|Baseline, Month 1, Month 2, Month 3 or ET|FAS|||ml||Standard Deviation|Mean
1226571|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
1226474|NCT00691093|Primary|Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit|Micturition frequency: mean number of ‘day time’ (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of ‘day time’ urinations, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)|The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.|||episodes||Standard Deviation|Mean
1226475|NCT00691054|Secondary|Median Overall Survival of Participants|Median overall survival rate of participants measured in months|12 months||||months||95% Confidence Interval|Median
1226476|NCT00691054|Secondary|Number of Participants Experiencing Adverse Events||6 months||||Participants|||Count of Participants
1226477|NCT00691054|Secondary|Progression-free Survival|Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months||||months||95% Confidence Interval|Median
1226478|NCT00691054|Secondary|Number of Participants Showing Stable Disease|Number of participants showing stable disease according to RECIST 1.0 criteria|12 months||||participants|||Number
1226479|NCT00691054|Secondary|Number of Participants Showing Complete or Partial Response|Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||participants|||Number
1226480|NCT00691054|Primary|Overall Survival Rate at 6 Months|Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.|6 months||||percentage of participants||95% Confidence Interval|Number
1226481|NCT00691028|Secondary|Pharmacokinetics Positive- ATI|ATI (antibody to Infliximab) was measured by a modification of an enzyme immunoassay.|54 weeks||||participants|||Number
1226482|NCT00691028|Secondary|Pharmacokinetics- Serum Concentration of Infliximab|Serum level of infliximab was measured by enzyme-linked immunosorbent assay (ELISA), using a monoclonal antibody against infliximab. The lowest level of infliximab that could be reliably detected was 0.1 ug/ml.|54 weeks|||||||
1226483|NCT00691028|Secondary|Change in Modified Total Sharp Score (mTSS) at week54 From Baseline|The mTSS is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 54 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 and joint space narrowing on a scale of 0 (no damage) to 4. Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 390 [maximal disease]). An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|baseline and week 54||||score||Inter-Quartile Range|Median
1226484|NCT00691028|Secondary|Change From Baseline to Week 54 in HAQ|HAQ: patient’s assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|54 weeks||||units on a scale||Standard Deviation|Mean
1226485|NCT00691028|Secondary|Change From Baseline in DAS28|DAS28 is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative change score indicates improvement. Total score range:0 to 9.4, higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 to 9.4 implied high disease activity and <2.6 implied remission.|baseline and week 54||||units on a scale||Standard Deviation|Mean
1226486|NCT00691028|Secondary|CRP Level|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range of CRP is 0 mg/dL to 0.3 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|54 weeks||||mg/dl||Inter-Quartile Range|Median
1226487|NCT00691028|Secondary|Swollen Joint Count (SJC)|The SJC was determined by examination of 66 joints and identifying when swelling was present. The SJC was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|54 weeks||||count||Standard Deviation|Mean
1226488|NCT00691028|Secondary|Tender Joint Counts (TJC)|The TJC was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The TJC was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|54 weeks||||count||Standard Deviation|Mean
1226489|NCT00691028|Secondary|Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)|ACR 20 (50 or 70) response is a decrease of at least 20% (50% or 70%) in both TJC and SJC and in 3 to 5 assessments (patient's assessment of pain [VAS] with 0, no pain to 100, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 100, very poor and 0, no arthritis activity to 100, extremely active, respectively]; [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; [CRP])|54 weeks||||percentage of participants|||Number
1226505|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
1226490|NCT00691028|Primary|Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)|The ACR-N index of improvement is the minimum of the following: (1) the percent decrease from baseline in tender joint counts(TJC) or (2) the percent decrease from baseline in swollen joint counts(SJC) or (3) the median percent decrease from baseline for the following: a. Patient’s assessment of pain (visual analog scale (VAS) 0-100, 100 worst pain); b. Patient’s global assessment of disease activity (VAS 0-100); c. Physician’s global assessment of disease activity (VAS 0-100); d. Physical function as measured by the Health Assessment Questionnaire(HAQ)(0-3); e. C-Reactive Protein(CRP) measurement. Higher numbers (maximum:100) indicate more improvement.|baseline and week 54||||percent change||Standard Deviation|Mean
1226491|NCT00691015|Secondary|Karnofsky Performance Status Performance Status|"100 – Normal; no complaints; no evidence of disease. 90 – Able to carry on normal activity; minor signs or symptoms of disease. 80 – Normal activity with effort; some signs or symptoms of disease. 70 – Cares for self; unable to carry on normal activity or to do active work. 60 – Requires occasional assistance, but is able to care for most of their personal needs.~50 – Requires considerable assistance and frequent medical care. 40 – Disabled; requires special care and assistance. 30 – Severely disabled; hospital admission is indicated although death not imminent.~20 – Very sick; hospital admission necessary; active supportive treatment necessary.~10 – Moribund; fatal processes progressing rapidly. 0 – Dead"|At 90 days after PBSCT|All participants|||units on a scale||Full Range|Median
1226492|NCT00691015|Secondary|Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)||Within 6 months after PBSCT|All participants|||percentage of participants||95% Confidence Interval|Number
1226493|NCT00691015|Secondary|Overall Survival.||At 2 years after PBSCT||||percentage of participants||95% Confidence Interval|Number
1226494|NCT00691015|Secondary|Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )||post transplant, up to 4 weeks|All participants|||Days||Full Range|Median
1226495|NCT00691015|Secondary|Incidence of Chronic GVHD.||Within 2 years after PBSCT|All participants|||percentage of participants||95% Confidence Interval|Number
1226496|NCT00691015|Primary|Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment.||Within 6 months after PBSCT|All participants|||% of participants with a reported SAE||95% Confidence Interval|Number
1226497|NCT00691015|Primary|Severity of Acute Graft-versus-host Disease (GVHD)||Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria|The patients that contracted sever acute graph versus host disease (aGVHD) from those who developed aGVHD|||% of participants with severe aGVHD||90% Confidence Interval|Number
1226498|NCT00691015|Primary|Incidence of Acute Graft-versus-host Disease (GVHD)||Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria||||percentage of participants||90% Confidence Interval|Number
1226499|NCT00690924|Primary|Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks|"Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.~CTEP Version 4 of the CTCAE is identified and located at:~http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm."|3 months|All treated and eligible patients|||participants|||Number
1226500|NCT00690898|Secondary|Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline|Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||units on a scale||95% Confidence Interval|Mean
1226501|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
1226502|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
1226503|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
1226504|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
1226506|NCT00690898|Secondary|Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels||Week 12, 24 and 48|Analysis based on the number (n) of subjects with baseline level between 20 ng/ml and 100 ng/ml in the ITT population with a valid value.|||mcg/L||Standard Deviation|Mean
1226509|NCT00690898|Secondary|Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).||Baseline (week 1) to week 12 and week 24|Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.|||participants|||Number
1226510|NCT00690898|Primary|Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)|A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant.|Week 1 and Week 48|Analysis based on intent-to-treat (ITT) population comprised of 89 patients.|||percentage of subjects||95% Confidence Interval|Number
1226511|NCT00690833|Primary|Investigator Global Assessment at Week 4|The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe|Week 4||||units on a scale||Standard Deviation|Mean
1226512|NCT00690820|Secondary|Percentage of Days With no Abdominal Pain.|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
1226513|NCT00690820|Secondary|Percentage of Days With Formed/Normal Stools.|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
1226514|NCT00690820|Secondary|Percentage of Days With no Flatulence.|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
1226515|NCT00690820|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Number per day||Standard Deviation|Mean
1226516|NCT00690820|Secondary|Total Stool Weight (Grams)|Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Grams||Standard Deviation|Mean
1226517|NCT00690820|Secondary|Total Fat Excretion (Grams)|Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Grams||Standard Deviation|Mean
1226518|NCT00690820|Secondary|Coefficient of Nitrogen Absorption (%)|This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage||Standard Deviation|Mean
1226519|NCT00690820|Primary|Coefficient of Fat Absorption (%)|This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage||Standard Deviation|Mean
1226520|NCT00690794|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by the total number of patients analyzed.|Day 90|Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.|||percentage of patients|||Number
1226521|NCT00690794|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point score) used to measure ocular symptoms, visual function and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|Baseline, Day 90|Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.|||Units on a scale||Standard Error|Mean
1226522|NCT00690755|Primary|Alterations in PKC-zeta mRNA in Vastus Lateralis Skeletal Muscles|All muscle samples obtained by 9/30/07, final date for examination of samples 9/30/08 Muscle dependent ability to diminish blood glucose levels during insulin treatment.|PKC-zeta mRNA levels and aPKC activity in muscle evaluated 40 minutes post-insulin treatment|PKC-zeta mRNA and aPKC activity in vastus lateralis skeletal muscle was measured by analysis of gene expression levels of PKC and measuring them in relative amounts in comparison to control subjects.|||arbitrary units/ng rRNA||Standard Error|Mean
1226523|NCT00690612|Primary|Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).|Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.|every 3 months - baseline to final visit||||mm Hg||Standard Deviation|Mean
1226524|NCT00690612|Primary|Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).|Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.|Every 3 months- baseline to final visit||||Millimeters of Mercury (mm Hg)||Standard Deviation|Mean
1226525|NCT00690573|Secondary|Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)|Serum samples with adalimumab concentration below 2 mcg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.|Week 24 and Week 60||||Participants|||Number
1226526|NCT00690573|Secondary|Mean Serum Adalimumab Concentration|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL).|Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60|For the 20 mg dose, N = 8 at each timepoint. For the 40 mg dose, N = 17 at Weeks 2 and 4; N = 16 at Weeks 8, 16, and 24; N = 14 at Week 36; N = 15 at Week 48; and N = 14 at Week 60.|||mcg/mL||Standard Deviation|Mean
1226527|NCT00690573|Secondary|Number of Subjects Achieving PedACR 30/50/70 Responses||Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit|The analysis was conducted using the full analysis set (FAS) population (all subjects who received at least 1 dose of study drug) as observed. N=25 at Weeks 2, 4, and the Final Visit; N=24 at Weeks 8, 24, and 36; N=23 at Week 48; N=22 at Week 60; N=19 at Weeks 72 and 96; N=11 at Week 120; and N=5 at Week 144.|||Participants|||Number
1226528|NCT00690573|Secondary|Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16|Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug. Missing values were treated as non-responders.|||Participants|||Number
1226529|NCT00690573|Primary|Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16|Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug.|||Participants|||Number
1226530|NCT00690495|Secondary|Further Assessment of Injection Pain||during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia|||||||
1226531|NCT00690495|Primary|Incidence of Expression of Pain During Injection||during first propofol bolus|per protocol|||participants|||Number
1226532|NCT00690482|Secondary|Adverse Event|The number of participants that experienced at least one adverse event.|Up to 4 Weeks|The safety analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo.|||Participants|||Number
1226533|NCT00690482|Secondary|Total Use of Reliever|Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Number of inhalations per day||Full Range|Mean
1226534|NCT00690482|Secondary|PEF (Peak Expiratory Flow) Evening|Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Full Range|Mean
1226535|NCT00690482|Secondary|PEF (Peak Expiratory Flow) Morning|Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Full Range|Mean
1226536|NCT00690482|Secondary|COPD Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
1226537|NCT00690482|Secondary|COPD Symptom Cough Score|Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
1226572|NCT00690378|Secondary|Microbiological Outcome in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
1226538|NCT00690482|Secondary|COPD Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
1226539|NCT00690482|Secondary|COPD Symptom Sleep Score|Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
1226540|NCT00690482|Secondary|FEF25%-75%|Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/s||Full Range|Mean
1226541|NCT00690482|Secondary|Inspiratory Capacity|Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Full Range|Mean
1226542|NCT00690482|Secondary|Slow Vital Capacity|Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Full Range|Mean
1226543|NCT00690482|Secondary|Forced Vital Capacity|Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Full Range|Mean
1226544|NCT00690482|Primary|Clinical COPD Questionnaire|Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
1226545|NCT00690482|Primary|FEV1|Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Full Range|Mean
1226546|NCT00690443|Secondary|Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.||Baseline and 4 weeks||||Percent||Standard Deviation|Mean
1226547|NCT00690443|Primary|Percent Change in LDL-C After 8 Weeks of Therapy||Baseline and 8 weeks of treatment||||Percent Change||Standard Deviation|Mean
1226548|NCT00690430|Secondary|Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
1226549|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
1226550|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
1226551|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
1226552|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria|Disease control rate (DCR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline, or a new lesion; or progression of non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Month 6|Full Analysis Set (FAS) consists of all patients randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Patients with analyzable data at month 6 were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
1226573|NCT00690378|Secondary|Microbiological Outcome in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
1226574|NCT00690378|Secondary|Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit|Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required|4 to 6 weeks post-therapy||||Participants|||Number
1226575|NCT00690378|Secondary|Clinical Outcome in CE Patients at the TOC Visit|Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required|5 to 9 days post-therapy||||Participants|||Number
1226553|NCT00690430|Secondary|Objective Tumor Response Rate Assessed by Investigator|Baseline evaluations were to include Triphasic CT scan or MRI of the abdomen. Triphasic CT or MRIs were to be read by same radiologist at each assessment, measuring the same target and non-target lesions and accounting for all lesions that were present at Baseline. All known disease was accounted for when assessing objective tumor status. Current objective tumor status was to be captured on Tumor Assessment CRF. Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|Month 6|Full Analysis Set (FAS) consists of all patients randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization. Patients randomized 6 months before the final clinical cutoff date were included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
1226554|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
1226555|NCT00690430|Secondary|Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.|Percent change from Baseline in total number of flushing episodes comprising Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. total number of flushing episodes at Baseline) and randomization stratum (D+F or F) as covariates.|6 months|The Efficacy analyzable set consists of the subset of FAS patients who were randomized at least six months prior to the futility DMC data cut-off. Patients were analyzed according the treatment they were assigned to at randomization. (ITT) principle.|||Percentage of Episodes||Standard Deviation|Mean
1226556|NCT00690430|Secondary|Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.|Percent change from Baseline in mean daily bowel movements at Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. mean daily bowel movement at Baseline) and randomization stratum (D+F or D) as covariates. Percentage change = (Month 6 - baseline)/baseline.|6 months|The Efficacy analyzable set consists of the subset of FAS patients who were randomized at least six months prior to the futility DMC data cut-off. Patients who had symptoms at baseline and at 6 months were included in this analysis.|||Percentage of Episodes||Standard Deviation|Mean
1226557|NCT00690430|Primary|Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.|Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): <4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of <5 flushing episodes. (CBRC) <4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of <4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.|Month 6|The Efficacy analyzable set consists of subset of FAS patients who were randomized at least six months prior to futility interim analysis data cut-off. It is for the primary efficacy analysis and secondary efficacy analysis except for tumor response assessment. Data reported was based on randomized patients at the time of the interim analysis.|||Percentage of Participants||95% Confidence Interval|Number
1226558|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
1226559|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
1226560|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
1226561|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
1226562|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
1226563|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
1226564|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
1226565|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
1226566|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
1226567|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
1226568|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
1226576|NCT00690378|Secondary|Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit|Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required|End of IV therapy (4 to 14 days)||||Participants|||Number
1226577|NCT00690378|Primary|Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
1226578|NCT00690339|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|10 years|All patients who had a breast implant satisfaction rating|||units on a scale||Standard Deviation|Mean
1226579|NCT00690339|Primary|Local Complications|By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts|10 years||||Percentage of Patients||95% Confidence Interval|Number
1226580|NCT00690235|Primary|Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine|Mean Number of Pounds Lost on Pramlintide Over 16 Weeks|16 weeks||||pounds||Standard Deviation|Mean
1226581|NCT00690040|Secondary|To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups||At the end of the study|||||||
1226582|NCT00690040|Primary|Average Time in Hours From Insertion of the Catheter Until Delivery||At the end of the study||||HOURS||Standard Deviation|Mean
1226583|NCT00689936|Secondary|Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base|Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed.|From randomization to 24 May 2013|||||||
1226584|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.|Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety population; Includes participants with baseline and postbaseline platelet laboratory test grade information|||participants|||Number
1226585|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase|Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population; Includes participants with baseline and postbaseline hemoglobin laboratory test grade information|||participants|||Number
1226586|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase|Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population; includes participants with baseline and postbaseline absolute neutrophil laboratory test grade information|||participants|||Number
1226587|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase|Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population with baseline and postbaseline CrCl data.|||participants|||Number
1226588|NCT00689936|Secondary|Number of Participants With Adverse Events (AEs) During the Active Treatment Phase|A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event.|From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety population included all participants who received at least one dose treatment dose of treatment in any arm|||Participants|||Number
1226589|NCT00689936|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) up to last visit completed 25 July 2016|Healthcare Resource Utilization not analyzed.||||||
1226590|NCT00689936|Secondary|Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score|EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1227480|NCT00683904|Secondary|Volume of Distribution at Steady State of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||Liters||Standard Deviation|Mean
1226591|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1226592|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1226593|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1226594|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s).|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1226595|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1226596|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1226597|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Constipation Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1226598|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
1226805|NCT00688753|Secondary|Objective Response Rate|ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression|End of trial||||% participants||90% Confidence Interval|Number
1226599|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Insomnia Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226600|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population includes all participants with available data.|||units on a scale||Standard Deviation|Mean
1226601|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226602|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226603|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226604|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226605|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226620|NCT00689936|Secondary|Time to First Response Based on the Review by the IRAC|The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Participants who had at least a PR.|||months||Full Range|Median
1226606|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226607|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226608|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226609|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
1226610|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a Cytogenetic Risk of Uncertain Risk|||percentage of participants|||Number
1226611|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a cytogenetic risk of normal|||percentage of particpants|||Number
1226761|NCT00689078|Primary|Ocular Redness at Day 6|Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1227542|NCT00683787|Secondary|Toxicity||1 year|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.||||||
1226612|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a Cytogenetic Risk of Favorable Hyperploidy|||percentage of participants|||Number
1226613|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with Cytogenetic risk of Adverse Risk|||Percentage of participants|||Number
1226614|NCT00689936|Secondary|Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population; Participants with second line AMT.|||percentage of participants|||Number
1226615|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis|Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.|From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.|||months||Full Range|Median
1226616|NCT00689936|Secondary|Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)|Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.|From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months|ITT population includes all participants who were randomized, independent of whether they received study treatment or not|||months||95% Confidence Interval|Median
1226617|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis|TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.|From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.|ITT population includes participants who were randomized, independent of whether they received study treatment or not|||months||95% Confidence Interval|Median
1226618|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Treatment Failure (TTF)|TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.|From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.|ITT population includes participants who were randomized, independent of whether they received study treatment or not|||months||95% Confidence Interval|Median
1226619|NCT00689936|Secondary|Time to First Response Based on the Investigator Assessment at the Time of Final Analysis|The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.|Participants who had at least a PR.|||months||Full Range|Median
1226766|NCT00689078|Primary|Ocular Itching at Day 6|Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1226621|NCT00689936|Secondary|Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis|Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.|Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months|Study participants with at least a PR|||months||95% Confidence Interval|Median
1226622|NCT00689936|Secondary|Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC|Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months|Study participants with at least a PR|||months||95% Confidence Interval|Median
1226623|NCT00689936|Secondary|Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.|||percentage of participants|||Number
1226624|NCT00689936|Secondary|Percentage of Participants With an Objective Response Based on IRAC Review|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.|||percentage of participants|||Number
1226625|NCT00689936|Secondary|Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)|Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive.|From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months|ITT population included all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
1226626|NCT00689936|Primary|Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis|PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).|From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months|The intent to treat population included all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
1226627|NCT00689936|Primary|Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)|PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).|From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.|The intent to treat (ITT) population included all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
1226806|NCT00688753|Secondary|Disease Control Rate (SD + PR + CR)|DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR|6 mos|PP,ITT|||% Participants||90% Confidence Interval|Number
1226628|NCT00689884|Secondary|Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants.|Costs will be divided into three categories: 1. Pre-pheresis preparation (cost of Pegfilgrastim, laboratory testing, drug administration, providers, line placement); 2. Pheresis procedure (costs related to # collections and total hours on apheresis machine, microbiological testing, provider, CD34 analysis and related labs, cryopreservation/storage and complications); 3. Post-pheresis processing (cost of stem cell thawing, microbiological testing, CD34 analysis and related labs, providers, administration).|At each stage of pheresis for each enrolled subject for a maximum of 2 years.|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.||||||
1226629|NCT00689884|Primary|Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.|2 years|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.||||||
1226630|NCT00689871|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|10 years|All patients who had a breast implant satisfaction rating|||units on a scale||Standard Deviation|Mean
1226631|NCT00689871|Primary|Local Complications|By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts|10 years|all enrolled patients|||percentage by patient||95% Confidence Interval|Number
1226632|NCT00689819|Secondary|Change in Prevalence of PCCD|To measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients.|Baseline and 1 year||||percentage of participants|||Number
1226633|NCT00689819|Primary|Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life|To evaluate the ability of this program to produce (as a surrogate for heart failure prevention) a clinically significant difference in blood pressure lowering, health status and quality of life between the 2 treatment groups.|Baseline and 1 year||||mm Hg||95% Confidence Interval|Mean
1226634|NCT00689793|Secondary|Adherence to Treatment.|Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland)|4 weeks||||percentage of day||Standard Deviation|Mean
1226635|NCT00689793|Secondary|Response of Iron Supplementation on Mental Disorder|Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score >15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or <15) after placebo or treatment.|baseline and 4 weeks|Number of participant was set according the primary outcome.|||participants|||Number
1226636|NCT00689793|Secondary|Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test|Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate.|baseline and 4 weeks||||mLO2/kg/min||Standard Deviation|Mean
1226637|NCT00689793|Secondary|Ferritin Change Before and After 4 Weeks of Treatment/Placebo|Level of ferritin measured 4 weeks after randomization|baseline and 4 weeks||||ng/mL||Standard Deviation|Mean
1226638|NCT00689793|Secondary|Hemoglobin Variation Before and After Treatment vs Placebo|The level of hemoglobin measured 4 weeks after randomization|baseline and 4 weeks|The number of participants was calculated according to the primary outcome.|||g/L||Standard Deviation|Mean
1226639|NCT00689793|Primary|Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.|"The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from no fatigue=0 to very severe fatigue=10."|baseline and 4 weeks|The sample size for randomized volunteers was calculated using a two-sample comparison of means to detect a one point difference in the visual analogical scale (first outcome).|||centimeter||Standard Deviation|Mean
1226640|NCT00689728|Secondary|Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)|T-half life (t1/2, tau) is defined as the apparent steady state elimination within the dosing interval. T-half life was obtained by conducting a simulation consisting of 1000 participants using the study drug regimens (30 and 80 mg, intravenous infusion over 30 minutes, once every 3 weeks). The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the t-half life values were calculated for each dose group based on simulated data.|Pre-dose, Day 1 through Week 24|All randomized participants with evaluable PK t-half life data.|||Days||Standard Deviation|Mean
1226641|NCT00689728|Secondary|Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state|C-trough is defined as the concentration of LY at the end of the dosing interval at steady state. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the Ctrough values were calculated for each dose group based on simulated data.|Pre-dose, Day 1 through Week 24|All randomized participants with evaluable PK C-trough data.|||Micrograms per Milliliter||Standard Deviation|Mean
1226642|NCT00689728|Secondary|Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16|Serum immunoglobulin measured by Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM) levels.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline serum immunoglobulin assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||gram/Liter||Standard Deviation|Mean
1226762|NCT00689078|Primary|Ocular Redness at Baseline (Day 0)|A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1226643|NCT00689728|Secondary|Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes|B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this outcome, total B cells (CD20+CD3- cells) are expressed as the relative percent of lymphocytes. There is no reference range provided for this parameter by the performing laboratory.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline CD20 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percentage of Lymphocytes||Standard Deviation|Mean
1226644|NCT00689728|Secondary|Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16|B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this endpoint, total B cell counts (CD20+CD3- cells) are represented by number of cells per microliter. The reference range for the absolute counts is 43-602 cells per microliter.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline CD20 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Cells per Microliter||Standard Deviation|Mean
1226645|NCT00689728|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16|The FACIT Fatigue Score is a brief patient-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline FACIT assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Units on a Scale||Standard Deviation|Mean
1226646|NCT00689728|Secondary|Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16|EULAR28 categorizes clinical response based upon improvement since baseline in Disease Activity Score modified to include the 28 joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (patient global VAS). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units).|16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline EULAR28 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Participants|||Count of Participants
1226647|NCT00689728|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 16|Disease Activity Score (modified to include the 28 joint count [DAS28]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (patient global VAS). It is calculated by using the following formula:DAS28-CRP=0.56 times the square root of(28TJC)+0.28 times the square root of(28SJC)+0.36*natural log (ln)(CRP+1)+0.014*patient global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline DAS28 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Units on a Scale||Standard Deviation|Mean
1226648|NCT00689728|Secondary|Percent Change From Baseline in C-reactive Protein (CRP) at Week 16||Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline CRP assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percent Change||Standard Deviation|Mean
1226649|NCT00689728|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The HAQ-DI questionnaire scores the participant’s self-perception on the degree of difficulty when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do). The scores for each of the functional areas, which have a range from 0 to 3, are averaged to calculate the functional disability index. Higher scores are associated with greater disability.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline HAQ-DI assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Units on a Scale||Standard Deviation|Mean
1226650|NCT00689728|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16|Physician's global assessment of arthritis disease activity using a visual analog scale (VAS) which ranged from 0 to 100 millimeters, where 0 indicates no arthritis activity and 100 indicates extremely active arthritis.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline physician's disease activity assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Millimeters||Standard Deviation|Mean
1226763|NCT00689078|Primary|Ocular Itching at Day 28|Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1227543|NCT00683787|Secondary|Overall Survival||3 years|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.||||||
1226651|NCT00689728|Secondary|Change From Baseline in Participant's Assessment of Disease Activity at Week 16|Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 to 100 millimeters, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline disease activity assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Millimeters||Standard Deviation|Mean
1226652|NCT00689728|Secondary|Change From Baseline in Participant's Assessment of Joint Pain at Week 16|Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 millimeters, where 0 indicated no pain and 100 indicated worst possible pain.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline joint pain assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Millimeters||Standard Deviation|Mean
1226653|NCT00689728|Secondary|Change From Baseline in Swollen Joint Count at Week 16|The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline swollen joint assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Swollen Joints||Standard Deviation|Mean
1226654|NCT00689728|Secondary|Change From Baseline in Tender Joint Count at Week 16|The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline tender joint assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Tender Joints||Standard Deviation|Mean
1226655|NCT00689728|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR70 Responder is defined as a participant with at least 70% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire–Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|16 weeks|Non-responder imputation (NRI)/last observation carried forward; intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR70 assessment. Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percentage of Participants|||Number
1226656|NCT00689728|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as a participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire–Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|16 weeks|Non-responder imputation (NRI)/last observation carried forward; intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR20 assessment. Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percentage of Participants|||Number
1226657|NCT00689728|Secondary|Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16|Self-reported questionnaire of 36 questions in 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health). Each domain is scored by summing individual items and transforming scores into a 0-100 scale (higher scores=better health status/function). The mental and physical component summaries are based on the 8 domains. Component scores are transformed scores representing a mean (50) and standard deviation (10) in the general United States (US) population. Scores > or <50 are above or below the average US population.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline SF-36 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Units on a Scale||Standard Deviation|Mean
1226658|NCT00689728|Secondary|Number of Participants Experiencing An Adverse Event|Serious adverse events and other non-serious adverse events are located in the Reported Adverse Event section.|Baseline up to 68 weeks|Safety population defined as all participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
1226678|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.|||percentage of participants|||Number
1226807|NCT00688753|Primary|To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.|PFSR at 6 months based on central review|6 mos|PP, PPFF, ITT|||% participants||80% Confidence Interval|Number
1226659|NCT00689728|Primary|Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR50 Responder is defined as a participant with greater than 50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire–Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|16 weeks|Non-responder imputation/last observation carried forward (NRI/LOCF); intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR50 assessment. Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percentage of Participants|||Number
1226660|NCT00689611|Secondary|Composite Major Adverse Cardiovascular Events (MACE)|"All clinical end points were adjudicated by members of the Endpoints Evaluation Committee who were blinded to treatment assignment.~Composite MACE (death, myocardial infarction, unstable angina)"|12 months||||percentage of participants|||Number
1226661|NCT00689611|Primary|Smoking Abstinence|"The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm.~The primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials."|12 months||||percentage of participants|||Number
1226662|NCT00689481|Secondary|Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 Weeks|ITT|||participants|||Number
1226663|NCT00689481|Secondary|Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.|8 Weeks|ITT|||participants|||Number
1226664|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8|Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.|8 Weeks|ITT|||participants|||Number
1226665|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2-grade Improvement From Baseline at Week 8|Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.|8 Weeks|ITT|||participants|||Number
1226666|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8|Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.|8 Weeks|ITT|||participants|||Number
1226667|NCT00689481|Primary|Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|Intent-to-Treat (ITT) Population|||participants|||Number
1226668|NCT00689390|Primary|Number of Participants That Discontinued the LTFU Due to SAEs|An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.|From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)|All enrolled participants were included in safety analyses.|||participants|||Number
1226669|NCT00689390|Primary|Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU|Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.|From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)|All enrolled participants were included in safety analyses.|||participants|||Number
1226670|NCT00689390|Primary|Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci|Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS).|From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years)|All participants with TE-RAVs who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study. Participants could have had more than one TE-RAV. All TE-RAVs were observed in participants in the boceprevir studies (i.e. none of the participants in the narlaprevir study had a TE-RAV).|||participants|||Number
1226671|NCT00689390|Primary|Kaplan-Meier Exposure-adjusted Relapse Rate|The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = [(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)] / 365.25 days [for 1 year].|From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)|All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis.|||relapses per 1,000 person-years|||Number
1226672|NCT00689390|Primary|Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response)|Durability of response was assessed by the number of participants who relapsed during the LTFU among those that had achieved sustained virologic response (SVR) by 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 treatment study. In the current LTFU, participants were classified based on the last Hepatitis C Virus ribonucleic acid (HCV-RNA) result available at the time of the data cut-off date as follows: A participant was classified as a sustained virologic responder at a given time point if serum HCV-RNA was undetectable at that time point and there had not been a positive HCV-RNA since the participant was determined to have achieved SVR in the previous study. A participant was classified as a relapser if they were a sustained virologic responder in the previous treatment study and became serum HCV-RNA positive with no subsequent negative results during LTFU.|From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)|All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis.|||participants|||Number
1226673|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.|||percentage of participants|||Number
1226674|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.|||percentage of participants|||Number
1226675|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.|||percentage of participants|||Number
1226676|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.|||percentage of participants|||Number
1226677|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.|||percentage of participants|||Number
1226764|NCT00689078|Primary|Ocular Itching at Day 27|Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1227544|NCT00683787|Secondary|Progression-free Survival||3 years|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.||||||
1226679|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.|||percentage of participants|||Number
1226680|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.|||percentage of participants|||Number
1226681|NCT00689351|Other Pre-specified|Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose|Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.|1 month after the Toddler Dose (13 months of age)|Evaluable Toddler Immunogenicity Population|||Mcg/mL||95% Confidence Interval|Geometric Mean
1226682|NCT00689351|Other Pre-specified|Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series|Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series (7 months of age)|Evaluable Infant Immunogenicity Population|||Mcg/mL||95% Confidence Interval|Geometric Mean
1226683|NCT00689351|Secondary|Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population:41-99 days old inclusive on day of first vaccination, 365-395 days old inclusive at toddler dose, had all treatments as randomized, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations|||percentage of participants||95% Confidence Interval|Number
1226684|NCT00689351|Primary|Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).|1 month after the infant series (7 months of age)|Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.|||percentage of participants||95% Confidence Interval|Number
1226685|NCT00689338|Secondary|Time to Successful Intensive Care Unit (ICU) Discharge|Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.|Day 1 up to Day 56|MITT. N = participants who had a successful ICU discharge.|||days||95% Confidence Interval|Mean
1226686|NCT00689338|Secondary|Day 90 Survival|Percentage of participants known or assumed to be alive on Day 90.|Day 90|MITT|||percentage of participants||95% Confidence Interval|Number
1226687|NCT00689338|Secondary|Time to First Negative Blood Culture|Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.|Day 1 up to Day 42|MITT. N = participants who received a minimum of 3 days of dosing with anidulafungin, excluding participants who experienced invasive candidiasis either at baseline or while on anidulafungin and participants who did not have a first negative blood culture by EOIVT.|||days||95% Confidence Interval|Mean
1226688|NCT00689338|Secondary|Percentage of Participants With Global Response Success 6 Weeks After End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)|MITT; N excludes participants with missing or unknown global responses.|||percentage of participants||95% Confidence Interval|Number
1226765|NCT00689078|Primary|Ocular Itching at Day 7|Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1227545|NCT00683787|Primary|Overall Response Rate||1 year|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.||||||
1226689|NCT00689338|Secondary|Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)|MITT; N excludes participants with missing or unknown global responses.|||percentage of participants||95% Confidence Interval|Number
1226690|NCT00689338|Secondary|Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|EOIVT (Day 10 up to Day 42)|MITT; N excludes participants with missing or unknown global responses.|||percentage of participants||95% Confidence Interval|Number
1226691|NCT00689338|Primary|Percentage of Participants With Global Treatment Response Success at End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|End of Treatment (Day 14 to Day 56)|Modified Intent-To-Treat (MITT) analysis set: all participants in the ITT population with confirmed diagnosis of candidemia or invasive candidiasis, documented within 96 hours prior to initiation of study treatment or 48 hours after commencing treatment. N excludes participants with missing or unknown global responses.|||percentage of participants||95% Confidence Interval|Number
1226692|NCT00689299|Primary|Scores on a Scale (Average of Total Symptom Scores)|"Sum of individual symptoms scores, 7 items, 21 points maximum~Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat.~Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures."|20 weeks|Modified Intent to Treat. All subjects with at least 1 symptom assessment during post treatment chamber exposure|||Scores on a scale||Standard Deviation|Mean
1226693|NCT00689260|Secondary|Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.|||Participants|||Number
1226694|NCT00689260|Secondary|Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.|||Participants|||Number
1226695|NCT00689260|Secondary|Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the Easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.|||Participants|||Number
1226696|NCT00689260|Primary|Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. Seven subjects who had damaged devices or incorrect device setting were excluded from this analysis set.|||Percent of injections missed||Full Range|Median
1226697|NCT00689221|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters||Up to 50 months|Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section.||||||
1226698|NCT00689221|Secondary|Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI−CTC Toxicity Grade 3 or 4|Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||Participants|||Number
1226731|NCT00689104|Secondary|Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||percentage of participants|||Number
1226699|NCT00689221|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||Participants|||Number
1226700|NCT00689221|Secondary|Number of Participants With Change From Baseline in Work Status at End of Study|Number of participants with change from baseline in work status (working full time [FT], part-time [PT], unemployed/retired [U/R]) at end of study (EOS) (up to cut-off date, [19 Nov 2012]) was reported. For the category ‘part-time’, the following sub-categories were defined: part-time due to basic disease (PT1); part-time not due to basic disease (PT2); part-time reason not known (PT3).|Baseline, End of study (up to cut-off date, [19 Nov 2012])|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||participants|||Number
1226701|NCT00689221|Secondary|EuroQol 5-Dimensions (EQ-5D) Questionnaire Index|The EuroQuol-5D (EQ-5D) questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.594 (death) and the highest is 1.00 (full health).|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1226702|NCT00689221|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores|The QLQ-BN20 is a questionnaire specifically designed as the QLQ-C30 supplement for the evaluation of quality of life in brain tumor participants. It includes 4 multi-item sub-scales: future uncertainty, visual disorder, motor dysfunction, communication deficits, and 7 single-item scales: headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs, and bladder control. All items are rated on a 4-point Likert-type scale (‘1=not at all’, ‘2=a little’, ‘3=quite a bit’ and ‘4=very much’), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category.|||units on a scale||Standard Deviation|Mean
1226703|NCT00689221|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores|The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category.|||units on a scale||Standard Deviation|Mean
1226704|NCT00689221|Secondary|Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose|The AUC (0-6) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||hour*ng/mL||Standard Deviation|Mean
1226705|NCT00689221|Secondary|Time to Maximum Plasma Concentration (Tmax)|The Tmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1."|||hours||Standard Deviation|Mean
1226706|NCT00689221|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1226754|NCT00689091|Secondary|Overall Use of Anesthetics Comparing the BIS to MAC Alerts.||During surgery (45 minutes - 18 hours)||||mg||Inter-Quartile Range|Median
1226755|NCT00689091|Secondary|Percentage of Cases With Electronic Alerts||During surgery: (45 minutes - 18 hours)||||Percentage of cases||Standard Deviation|Mean
1226707|NCT00689221|Secondary|Progression Free Survival (PFS) Time - Investigator and Independent Read|"The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site and Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). Investigator’s assessed progression according to MacDonald criteria and IRC by Response Assessment in Neuro-Oncology Working Group (RANO) criteria using Gadolinium-enhanced magnetic resonance imaging.~Investigator and IRC read: Progression is defined as greater than 25 percent increase in the sum of the product of the largest perpendicular diameters of enhancing tumor compared to the smallest prior sum, or Worsening of an evaluable lesion(s),or Marked increase in T2/FLAIR non-enhancing lesions (IRC only) or Any new lesion"|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)|ITT population included all the participants who were randomized to study treatment.|||Months||95% Confidence Interval|Median
1226708|NCT00689221|Primary|Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)|ITT population included all the participants who were randomized to study treatment.|||Months||95% Confidence Interval|Median
1226709|NCT00689117|Secondary|The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12|The ISGA is a static (“snap-shot”) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.|Week 12|ITT Population|||percentage of participants|||Number
1226710|NCT00689117|Secondary|The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12|The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.|Week 12|ITT Population|||participants|||Number
1226711|NCT00689117|Secondary|Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12|Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.|Baseline, Week 12|ITT Population|||percent change||Standard Deviation|Mean
1226712|NCT00689117|Primary|The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|The ISGA is a static (“snap-shot”) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.|Baseline, Week 12|ITT Population|||percentage of participants|||Number
1226713|NCT00689117|Primary|Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)|Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.|Baseline, Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product.|||lesions||Standard Deviation|Mean
1226714|NCT00689104|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
1226715|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Physician visits||Standard Deviation|Mean
1226716|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1226717|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1226718|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Deviation|Mean
1226719|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226720|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226721|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226722|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226723|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226756|NCT00689091|Secondary|Number of Participants With Dreams During Anesthesia Compared Between MAC or BIS Monitoring|Binary variables for whether participants recall dreaming or not.|During surgery (45 minutes - 18 hours), measured based on 30 day interviews||||Participants|||Count of Participants
1226757|NCT00689091|Primary|The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups.|By modified intention-to-treat analysis|Outcome of awareness is assessed 30-days after the operation||||Percentage of participants/30days||95% Confidence Interval|Number
1226724|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percent activity impairment||Standard Deviation|Mean
1226725|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent overall work impairment||Standard Deviation|Mean
1226726|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent impairment while working||Standard Deviation|Mean
1226727|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent work time missed||Standard Deviation|Mean
1226728|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was utilized for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||Scores on a scale||Standard Error|Least Squares Mean
1226729|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||Scores on a scale||Standard Error|Least Squares Mean
1226730|NCT00689104|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||percentage of participants|||Number
1226758|NCT00689078|Primary|Ocular Redness at Day 28|Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1226732|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||pads||Standard Error|Least Squares Mean
1226733|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||nocturia episodes||Standard Error|Least Squares Mean
1226734|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||Scores on a scale||Standard Error|Least Squares Mean
1226735|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||Urgency episodes||Standard Error|Least Squares Mean
1226736|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.|||Urgency incontinence episodes||Standard Error|Least Squares Mean
1226737|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as “N”.|||mL||Standard Error|Least Squares Mean
1226738|NCT00689104|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as “N”. LOCF was not used in this analysis.|||micturitions||Standard Error|Least Squares Mean
1226759|NCT00689078|Primary|Ocular Redness at Day 27|Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1226760|NCT00689078|Primary|Ocular Redness at Day 7|Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1226739|NCT00689104|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
1226740|NCT00689104|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.|||micturitions||Standard Error|Least Squares Mean
1226741|NCT00689104|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not utilized in this analysis.|||Incontinence episodes||Standard Error|Least Squares Mean
1226742|NCT00689104|Secondary|Change From Baseline to Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The Full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||mL||Standard Error|Least Squares Mean
1226743|NCT00689104|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||micturitions||Standard Error|Least Squares Mean
1226744|NCT00689104|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12 (final visit)|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
1226745|NCT00689091|Other Pre-specified|Incidence of Post-traumatic Stress Disorder.||NEED VALUE HERE|||||||
1226746|NCT00689091|Other Pre-specified|Meta-Analysis of Awareness Events in Conjunction With the BAG-RECALL Study Based at Washington University.||Outcome of awareness is assessed|||||||
1226747|NCT00689091|Other Pre-specified|Anesthetic Induction Doses, Hypotension, and BIS Values.||Outcome of hypotension in relationship to induction doses and BIS values will be assessed|||||||
1226748|NCT00689091|Other Pre-specified|Predictors of Post-traumatic Stress Disorder Based on the Type of Awareness Event.||Outcome of post-traumatic stress disorder is assessed with the covariate of awareness|||||||
1226749|NCT00689091|Other Pre-specified|The Relationship Between Cumulative Deep Hypnotic Time, Anesthetic Doses, and Mortality.||Outcome of mortality is assessed|||||||
1226750|NCT00689091|Other Pre-specified|Relationship Between BIS Values and Hemodynamic Parameters.||Outcome of hemodynamic stability is assessed|||||||
1226751|NCT00689091|Secondary|Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence.|There is controversy regarding the appropriate technique for assessing awareness during anesthesia with explicit recall. A total cohort was utilized to compare the incidence of awareness with recall as determined by formal interview vs. the incidence of awareness with recall based on spontaneous reports (in the same cohort).|30 days after surgery||||participants|||Number
1226752|NCT00689091|Secondary|Number of Participants Without Nausea or Vomiting||During recovery room stay: 30 minutes to 6 hours|Nausea and vomiting numbers were dependent on nurse reporting; as not all nurses did, the participants analyzed are fewer than the total number in the study.|||Participants|||Count of Participants
1226753|NCT00689091|Secondary|Time Till Discharge Readiness|measured in time within Post Anesthesia Care Unit ( PACU) until the participant is ready for discharge from PACU based on a composite of factors, including pain and neurologic status|During recovery room stay: 30 minutes to 6 hours||||minutes||Inter-Quartile Range|Median
1226767|NCT00689078|Primary|Ocular Itching at Baseline (Day 0)|A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1226768|NCT00689052|Secondary|Change From Baseline in Mean Tender Point Threshold|The Tender Point Pain Threshold will be assessed for all 18 tender points by a study clinician. A dolorimeter will be used to exert the pressure at each point and to measure the threshold reading; when the patient first indicates pain, the threshold will be recorded in kg/sq.cm ;If the patient reports pain before 1.0 kg/sq.cm is reached (>0 kg/sq.cm), 1.0 kg/sq.cm will be entered. If the patient does not report pain when the maximum pressure is applied (10.0 kg/sq.cm),0 (no pain) will be entered.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226769|NCT00689052|Secondary|Frequency of Rescue Medication for Pain|Acetaminophen/paracetamol (maximum of 4 g/day) to be allowed as rescue medication for pain.|Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226770|NCT00689052|Secondary|Clinical Global Impression of Severity (CGI-S Scores)|Clinical Global Impression of Severity (CGI-S) Scale is a clinician’s assessment of patient’s severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226771|NCT00689052|Secondary|Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)|The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226772|NCT00689052|Secondary|Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)|The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing .|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226773|NCT00689052|Secondary|Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)|The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient’s health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226774|NCT00689052|Secondary|The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).|"The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .~SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).~Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.~Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226775|NCT00689052|Secondary|Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).|The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226776|NCT00689052|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)|"FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week.~The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226777|NCT00689052|Secondary|The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale|11-Point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from: 0 = no pain to 10 = worst possible pain .|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226804|NCT00688753|Secondary|Duration of Response|The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.|End of trial|In the final analysis, for central review, the DOR could not be calculated as only 1 patient in the PP and ITT sets met the criteria|||days||95% Confidence Interval|Median
1226778|NCT00689052|Secondary|The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).|"The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .~SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).~Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.~Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226779|NCT00689052|Secondary|The Proportion of Patients “Very Much Improved” or “Much Improved” on the Patient’s Global Impression of Improvement (PGI-I) 7-point Scale|"PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment.~The score ranges from 1 = very much improved to 7 = very much worse"|Week 29 (at the end of the maintenance phase)|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226780|NCT00689052|Primary|The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale|The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
1226781|NCT00689026|Primary|The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.|The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial.|The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours|13 patients were excluded from the Experimental Arm (12 cancelled their appointment and 1 did not complete the prep) and 6 were excluded from the Control Arm (5 cancelled their procedure and 1 withdrew from the trial) therefore results were analyzed and compared using the chi-square statistics-Validated Aronchik colonoscopy cleansing grading scale.|||percentage of patients|||Number
1226782|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (15 months of age)|Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
1226783|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of the infant series (6 months of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
1226784|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after Dose 2 of the infant series (4 months of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
1226785|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after Dose 1 of the infant series (2 months of age)|Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1226786|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (15 months of age)|Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
1226787|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after Dose 3 of the infant series (6 months of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
1227256|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|6 months (approproximately study days 91 - 180)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1226788|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 Days after Dose 2 of the infant series (4 months of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
1226789|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after Dose 1 of the infant series (2 Months of Age)|Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1226790|NCT00688870|Other Pre-specified|GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (16 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||GMC mcg/mL||95% Confidence Interval|Geometric Mean
1226791|NCT00688870|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the 3-dose infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||GMC mcg/mL||95% Confidence Interval|Geometric Mean
1226792|NCT00688870|Secondary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after toddler dose (16 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1226793|NCT00688870|Primary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1226794|NCT00688844|Other Pre-specified|Change From Baseline in Serotonin at 12 Months|Objective: 1 year prospective cohort of PKU patients introduced to sapropterin (Kuvan)to evaluate peripheral neurotransmitter changes across time.|Baseline and 12 months|||||||
1226795|NCT00688844|Primary|Change From Baseline in Phenylalanine Intake at 12 Months|Total dietary phenylalanine assessed through 3-day food records - calculated as average phenylalanine intake (grams/day) in the 3 days recorded|Baseline and 12 months|Dietary intake not submitted by 11 participants at 12 months.|||grams per day||Standard Deviation|Mean
1226796|NCT00688844|Primary|Change From Baseline in Total Dietary Protein Intake at 12 Months|Total dietary protein intake assessed through 3-day food records - calculated as average protein intake (grams/day) in the 3 days recorded|Baseline and 12 months|Dietary intake not submitted by 11 participants at 12 months.|||grams per day||Standard Deviation|Mean
1226797|NCT00688844|Primary|Change From Baseline in Plasma Phenylalanine at 12 Months|Full amino acid panel, including phenylalanine, analyzed in fasting plasma samples.|Baseline and 12 months||||Micromoles per liter||Standard Deviation|Mean
1226798|NCT00688844|Primary|Change From Baseline in Percent (%) Fat Mass at 12 Months|Percent fat mass measured via dual energy x-ray absorptiometry (DXA)|Baseline and 12 months|Data missing for 3 participants|||Percent Fat Mass||Standard Deviation|Mean
1226799|NCT00688844|Primary|Change From Baseline in Percent (%) Lean Mass at 12 Months|% lean mass was measured via dual energy x-ray absorptiometry (DXA)|Baseline and 12 months|Data missing for 3 participants|||Percent Lean Mass||Standard Deviation|Mean
1226800|NCT00688844|Primary|Change From Baseline in Bone Mineral Density (BMD) at 12 Months|Change in bone mineral density (BMD) from baseline of Kuvan study to 12 months post-baseline|Baseline and 12 months|Data missing for 3 participants|||grams/centimeter^2||Standard Deviation|Mean
1226801|NCT00688844|Primary|Change From Baseline in BMI at 12 Months|Change in Body mass index (BMI) from baseline of Kuvan study to 12 months post-baseline|Baseline and 12 months|Data missing for 2 participants|||kg/m^2||Standard Deviation|Mean
1226802|NCT00688753|Secondary|Incidence of Adverse Events, Serious Adverse Events, and Death.||End of trial|Safety Set|||% participants|||Number
1226803|NCT00688753|Secondary|Median Progression Free Survival|PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.|End of trial||||days||95% Confidence Interval|Median
1226808|NCT00688740|Secondary|Number of Participants With Second Primary Malignancies (Toxicity)|Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast.|up to 10 year follow-up||||Participants|||Number
1226809|NCT00688740|Secondary|Number of Participants With Overall Survival Events|Overall Survival - time from the date of randomization up to the date of death of any cause.|up to 10 year follow-up||||Participants|||Number
1226810|NCT00688740|Primary|Number of Participants With Disease-Free Survival Events|Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.|up to 10 year follow-up|The study was originally designed to have 90% power to detect a 26% risk reduction of relapsing for TAC compared to FAC (hazard ratio=0.74)|||Participants|||Number
1226811|NCT00688701|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1226812|NCT00688701|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1226813|NCT00688701|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 12|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1226814|NCT00688701|Secondary|Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period|Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: >270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: >240 mg/dL (13.3 mmol/L). For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 12|mITT population.|||percentage of participants|||Number
1226815|NCT00688701|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1226816|NCT00688701|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1226817|NCT00688701|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1226818|NCT00688701|Secondary|Change From Baseline in Body Weight at Week 12|Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1226819|NCT00688701|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|Subgroup for standardized meal test. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1226820|NCT00688701|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1226821|NCT00688688|Secondary|Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram|"An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event.~The data reported represent the number of participants with adverse events in each category."|From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.|The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.|||participants|||Number
1226822|NCT00688688|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
1226823|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician’s office during the 4 weeks prior to each study visit (excluding study visits) because of the patient’s bladder condition.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Physician visits||Standard Deviation|Mean
1226824|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||scores on a scale||Standard Deviation|Mean
1226825|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226869|NCT00688467|Secondary|Change From Baseline in Sputum Myeloperoxidase (MPO) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. MPO level was measured in the sputum supernatant.|Baseline and 7 and 24 hours after allergen challenge|MPO level was not analyzed because too few evaluable samples were collected||||||
1227159|NCT00686517|Secondary|Number of Peripheral Blood Mononuclear Cells (PBMCs)|Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.|Treatment Weeks 2, 4, 8, and 12|The association between HCV specific immune and SR to be assessed applying descriptive methods could not be evaluated as PBMC measurements were not carried out.||||||
1226826|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226827|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226828|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226829|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1226830|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline value. LOCF was used for the Final Visit analysis.|||Percent activity impairment||Standard Deviation|Mean
1226831|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||Percent overall work impairment||Standard Deviation|Mean
1226832|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||Percent impairment while working||Standard Deviation|Mean
1227181|NCT00686257|Primary|Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)||During the first 3 hours of recruitment|By power analysis|||units on a scale||Standard Error|Mean
1227182|NCT00686231|Secondary|To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization.|Radial artery diameter|November 2009||2009-11-30|11/2009||||
1226833|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||Percent work time missed||Standard Deviation|Mean
1226834|NCT00688688|Secondary|Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled ‘No, not at all’ on the left (=0) to ‘Yes, completely satisfied’ on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit.|||scores on a scale||Standard Error|Least Squares Mean
1226835|NCT00688688|Secondary|Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit.|||scores on a scale||Standard Error|Least Squares Mean
1226836|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||scores on a scale||Standard Error|Least Squares Mean
1226837|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||scores on a scale||Standard Error|Least Squares Mean
1226838|NCT00688688|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit|The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
1226839|NCT00688688|Secondary|Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
1226870|NCT00688467|Secondary|Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. Neutrophil elastase activity was measured in the sputum supernatant as milli units/mL (mU/mL). Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples|||mU/mL||Standard Deviation|Least Squares Mean
1226840|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 nocturia episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||nocturia episodes||Standard Error|Least Squares Mean
1226841|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients who had at least 1 use of a pad at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit|||pads||Standard Error|Least Squares Mean
1226842|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit analysis.|||scores on a scale||Standard Error|Least Squares Mean
1226843|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 urgency episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||urgency episodes||Standard Error|Least Squares Mean
1226844|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 urgency incontinence episode at baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||urgency incontinence episodes||Standard Error|Least Squares Mean
1226845|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.|||mL||Standard Error|Least Squares Mean
1226846|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.|||incontinence episodes||Standard Error|Least Squares Mean
1227183|NCT00686231|Primary|To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery.|Diameter of radial artery|November 2009||||mm||Standard Deviation|Mean
1227546|NCT00683774|Primary|Level of Circulating D-chiro Inositol (DCI)|Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide|12 days||||nmol/mL||Full Range|Mean
1226847|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.|||micturitions||Standard Error|Least Squares Mean
1226848|NCT00688688|Primary|Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)|"An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities."|From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.|The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.|||participants|||Number
1226849|NCT00688662|Secondary|Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.|Successful outcome was defined using the primary outcome definition of success at 12 months post randomization. Abnormal sphincter manometry was determined as a basal pressure of more than 40mm Hg in both leads.|1 year|Participants with abnormal sphincter manometry|||percentage of participants with success|||Number
1226850|NCT00688662|Primary|Percentage of Participants With Success|The primary outcome was a dichotomous (success/failure) variable. Success was defined as patients having a RAPID score of <6 days at months 9 and 12 post-procedure, without re-intervention and without use of prescription analgesics during months 10, 11 and 12 unless used for non-abdominal pain for no more than 14 days. The subject was considered a failure if the 12-month RAPID score was missing or collected outside the acceptable window. If the 9-month RAPID was missing, or outside of the window, then the 6-month value was used when available.|1 year|The primary analysis was conducted with the intention-to-treat population defined as all randomized patients.|||percentage of paricipants with success||95% Confidence Interval|Number
1226851|NCT00688636|Secondary|Mean Erythrocyte Sedimentation Rate|erythrocyte sedimentation rate value - blood test|one year||||mm/h||Full Range|Median
1226852|NCT00688636|Secondary|C-reactive Protein Concentration as a Surrogate Marker of Inflammation|The CRP was obtained at each study visit as a surrogate marker of inflammation. The CRP was recorded as milligram per deciliter (mg/dl). A normal CRP was 0-0.8 mg/dl; levels exceeding 0.8 mg/dl indicated inflammation.|one year||||mg/dL||Full Range|Median
1226853|NCT00688636|Secondary|Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis|Histologic recurrence based on a histologic activity score and the presence of polymononuclear cells. The maximum score is 14 per biopsy site.|One year|Histologic activity score|||participants|||Number
1226854|NCT00688636|Secondary|Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200|The Crohn's Disease Activity Index (CDAI) is calculated by a measurement of symptoms, signs, and lab tests over a time period of the previous 7 days. The CDAI includes: Number of very soft stools; sum of abdominal pain ratings: (0=none, 1= mild, 2=moderate, 3=severe); general well being (0=well, 1=slightly below par, 2=poor, 3=very poor, 4=terrible); Symptoms or findings presumed related to Crohn's disease (present): arthritis or arthralgia, iritis or uveitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, anal fissure, fistula or perirectal abscess, other bowel related fistula, febrile episode over 100 degrees during past week, taking lomotil or opiates for diarrhea, abnormal mass (0=none; 0.4=questionable; 1=present) hematocrit [(typical-current) X 6] Normal average male = 47, female =42, body weight|One year|CDAI score > 200|||participants|||Number
1226855|NCT00688636|Primary|Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year|Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts’ Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.|one year|The proportion of patients with endoscopic recurrence (> or = i2) at 1 year after surgery|||participants|||Number
1226856|NCT00688597|Secondary|Change In 6-minute Walk Test (6MWT) From Baseline To End Of Study|The 6MWT (American Thoracic Society standards) was evaluated in ambulatory participants at screening, baseline, and to the end of the study. It was a standardized test that measured the distance in meters (m) covered over a 6-minute walk. Reference equations used (for 6MWT distance in healthy adults) included: (height in centimeters [cm], weight in kilograms [kg]) 6MWT distance for men = [7.57 × height (cm)] – [5.02 × age] – [1.76 × weight (kg)] – 309 m; 6MWT distance for women = [2.11 × height (cm)] – [5.78 × age] – [2.29 × weight (kg)] + 667 m|Baseline, Week 11|Safety Population: All participants who received at least 1 dose of duvoglustat.|||m||Standard Deviation|Mean
1226871|NCT00688467|Secondary|Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. IL-8 level was measured in the sputum supernatant. Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples|||pg/mL||Standard Deviation|Least Squares Mean
1232662|NCT00640224|Primary|Glucose Tolerance Status at Baseline and 6 Months.|Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.|Baseline and 6 months||||Participants|||Count of Participants
1226857|NCT00688597|Primary|Proportion Of Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs)|The number of participants experiencing severe TEAEs is presented for participants who received duvoglustat treatment in this open-label study. The duration of duvoglustat exposure for Cohort 1 ranged from 2 to 24 days, and their exposure ranged from a total of 7,500 to 32,500 milligrams of duvoglustat. An adverse event (AE) refers to any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation in the clinical study. The following guideline was used to grade the intensity of an AE: mild, the AE is easily tolerated and does not interfere with daily activity; moderate, the AE interferes with the daily activity but the participant is still able to function; severe, the AE is incapacitating and requires medical intervention. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline, Week 11|Safety Population: All participants who received at least 1 dose of duvoglustat.|||Participants|||Count of Participants
1226858|NCT00688545|Primary|JIA Concomitant Medications|JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication.|Year 2 or early termination|Safety Analysis Set subset of participants who received JIA concomitant medications|||Participants|||Number
1226859|NCT00688545|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry.|Baseline up to 2 years|Safety Analysis Set: participants who were prescribed at least one dose of any NSAID. Participants who switched treatment were counted for the NSAID utilized at the time of the event, regardless of the initial NSAID treatment at enrollment.|||Participants|||Number
1226860|NCT00688519|Secondary|Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|ITT|||participants|||Number
1226861|NCT00688519|Secondary|Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.|8 weeks|ITT|||participants|||Number
1226862|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8|Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.|8 weeks|ITT|||participants|||Number
1226863|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8|Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.|8 weeks|ITT|||participants|||Number
1226864|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8|Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.|8 weeks|ITT|||participants|||Number
1226865|NCT00688519|Primary|Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|Intent-to-Treat (ITT) Population|||particpants|||Number
1226866|NCT00688467|Secondary|Number of Participants Discontinued From the Study Because of an Adverse Event|An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. Discontinuations due to an AE are reported based on the study drug taken at the time of the event.|Up to 48 days|The population analyzed included all participants who received study drug|||Participants|||Number
1226867|NCT00688467|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. AEs were reported based on the study drug taken at the time of the event.|Up to 48 days|The population analyzed included all participants who received study drug|||Participants|||Number
1226868|NCT00688467|Secondary|Change From Baseline in Sputum Eosinophil Cationic Protein (ECP) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. ECP level was measured in the sputum supernatant.|Baseline and 7 and 24 hours after allergen challenge|ECP level was not analyzed because too few evaluable samples were collected||||||
1226872|NCT00688467|Secondary|Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and had evaluable blood samples available|||Percent change from baseline||Standard Deviation|Least Squares Mean
1226873|NCT00688467|Secondary|Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were collected via the nebulized method. Baseline values were determined at 24 hours before allergen challenge in each treatment period. Sputum neutrophils were measured as percent of total white blood cells. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples|||Percent change from baseline||Standard Deviation|Least Squares Mean
1226874|NCT00688467|Secondary|Maximum Percent Change From Baseline in FEV1 During the Early Asthmatic Response Following 9 Days of Pretreatment With Navarixin|Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. The EAR was 0 to 2 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 0 to 2 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Percent change from baseline||Standard Deviation|Least Squares Mean
1226875|NCT00688467|Secondary|Percent Change From Baseline in FEV1 Area Under the Curve From 0 to 2 Hours (AUC0-2hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|This is a measure of Early Asthmatic Response (EAR) between 0 to 2 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. A percent change >0 indicates a reduction in FEV1 from before to after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 0 to 2 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Percent change from baseline||Standard Deviation|Least Squares Mean
1226876|NCT00688467|Secondary|Change in Concentration of Methacholine That Initiated a 20% Reduction in FEV1 From 24 Hours Before (Baseline) to 24 Hours After Allergen Challenge|This is a measure of allergen-induced changes in airway responsiveness to methacholine. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Log methacholine (mg/mL)||Standard Deviation|Least Squares Mean
1226877|NCT00688467|Secondary|Maximum Change From Baseline in FEV1 During the LAR Following 9 Days of Pretreatment With Navarixin|Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. The LAR was 3 to 7 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 3 and 7 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Liters||Standard Deviation|Least Squares Mean
1226878|NCT00688467|Primary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change >0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 3 and 7 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Percent change from baseline||Standard Deviation|Least Squares Mean
1226879|NCT00688324|Secondary|Cognitive Impairment|"Cognitive tests will include the DigitSymbol Test (evaluating processing speed), California Verbal Learning Test (CVLT; evaluating verbal learning and episodic memory), and NBack (evaluating working memory).~Digit Symbol scaled scores range from 1 to 19, with the larger numbers indicating better performance.~On the CVLT, the delayed recognition score ranges from 0 to 16, with the larger numbers indicating better performance.~On the NBack test, subjects were asked to recall items 0-back, 1-back, and 2-back in a sequence. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower."|Change from Baseline (Treatment Week 0) to End of Study (Treatment Week 2)|Subjects who completed cognitive testing at both study time points.|||units on a scale||Standard Deviation|Mean
1226880|NCT00688324|Secondary|SANS - Negative Symptoms of Schizophrenia Total Score|Negative symptoms of schizophrenia measured using the Scale for the Assessment of Negative Symptoms (SANS) Total Score. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Baseline (Treatment Week 0) and End of Study (Treatment Week 2)|Subjects completing the SANS assessment at each time point.|||units on a scale||Standard Deviation|Mean
1232663|NCT00640224|Primary|Hepatic Insulin Sensitivity at Baseline and 6 Months.|Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.|Baseline and 6 months||||(mg/kg/min x uU/mL)-1||Standard Error|Mean
1226881|NCT00688324|Secondary|BPRS - Symptoms of Psychosis Total Score|"The psychosis total score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Baseline (Treatment Week 0) and End of Study (Treatment Week 2)|Subjects completing BPRS rating at each time point.|||units on a scale||Standard Deviation|Mean
1226882|NCT00688324|Secondary|BPRS - Symptoms of Psychosis Change in Scores|"Symptoms of psychosis were measured with the Brief Psychiatric Rating Scale (BPRS). The items rated for psychosis are Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content. Each item score ranges from 1=Not Present to 7=Very Severe.~Value at End of Study minus value at Baseline."|Baseline (Treatment Week 0) and End of Study (Treatment Week 2)|Subjects completing the BPRS rating at Baseline and End of Study.|||units on a scale||Standard Deviation|Mean
1226883|NCT00688324|Primary|Fractional Anisotropy Measured With Diffusion Tensor Imaging|Diffusion Tensor Imaging Frational Anisotropy (FA) Measures by Lifetime History of Alcohol Abuse/Dependence and Brain Hemisphere.|Completion of two scans|Subjects completing study (both scans).|||FA||Standard Deviation|Mean
1226884|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - Myo-inositol|"Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226885|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - N-acetylaspartate|"N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226886|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - Glutamate|"Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226887|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - Creatinine|"Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226888|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - Choline|"Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226889|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - Myo-inositol|"Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226890|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - N-acetylaspartate|"N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226891|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - Glutamate|"Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226892|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - Creatinine|"Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226893|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - Choline|"Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
1226894|NCT00688324|Primary|Anterior Cingulate Cortex - Myo-inositol|"Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
1227294|NCT00685334|Secondary|Medication Side Effects|Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.|Measured at Week 12|||||||
1226895|NCT00688324|Primary|Anterior Cingulate Cortex - N-acetylaspartate|"N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
1226896|NCT00688324|Primary|Anterior Cingulate Cortex - Glutamate|"Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
1226897|NCT00688324|Primary|Anterior Cingulate Cortex - Creatinine|"Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
1226898|NCT00688324|Primary|Anterior Cingulate Cortex - Choline|"Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
1226899|NCT00688259|Secondary|Changes in Distress From Schizophrenia Symptoms|"Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress~Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889."|Pre-treatment to follow-up, approximately 6 months post end-of-treatment||||units on a scale||Standard Error|Least Squares Mean
1226900|NCT00688259|Secondary|Changes in Distress From Schizophrenia Symptoms|"Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress~Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889."|Pre-treatment to end-of-treatment, approximately 6 months post-randomization||||units on a scale||Standard Error|Least Squares Mean
1226901|NCT00688259|Primary|Changes in Global Social Functioning|"Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler N, Hogarty G, Weissman M:, 1979) with low scores indicating better functioning~Schooler N, Hogarty G,& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303)"|Pre-treatment to follow-up, approximately 6 months post end-of-treatment||||units on a scale||Standard Error|Least Squares Mean
1226902|NCT00688259|Primary|Changes in Global Social Functioning|"Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler, Hogarty, Weissman:, 1979) with low scores indicating better functioning~Schooler N, Hogarty G,& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303)"|Pre-treatment to end of treatment, approximately 6 months post-randomization||||units on a scale||Standard Error|Least Squares Mean
1226903|NCT00688259|Primary|Changes in Positive Schizophrenia Symptoms|"Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, & Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms~Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243"|Pre-treatment to follow-up, approximately 6 months post end-of-treatment||||units on a scale||Standard Error|Least Squares Mean
1226904|NCT00688259|Primary|Changes in Positive Schizophrenia Symptoms|"Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, & Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms~Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243"|Pre-treatment to end of treatment, approximately 6 months post-randomization||||units on a scale||Standard Error|Least Squares Mean
1226905|NCT00688155|Secondary|Composite Episodic Memory|"Composite of 4 components.~The Hopkins Verbal Learning Test (HVLT) of verbal learning. Subjects hear 12 words and repeat as many as possible. This is repeated twice for a total of 3 trials. 20 mins later the subject is asked to recall as many words as possible. Subjects also do a recognition trial with 24 words. Scores for immediate and delayed recall, and recognition are calculated.(Brandt J. Clin Neuropsych 1991;5:125-42).~The Logical Memory (LM) test The LM test has 2 parts. In Part 1, subjects hear a story and recall as many pieces as possible immediately and after a 30 minute delay. Subjects receive a story unit score for accuracy of re-telling story details and a thematic score for recalling story themes. The higher the scores the better the performance. ( Wechsler D. The Wechsler Memory Scale-3rd Edition (WHM-III). Psycholog Corp, Harcourt, Inc.)~Individual scores are converted to z-scores and averaged to form the composite."|Change a 4 months|Participants assessed at 4 months|||z-scores (e.g. SD units)||Standard Error|Mean
1226906|NCT00688155|Secondary|Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below.|"Composite of 5 tasks:~Self-Ordered Pointing Task of planning, working memory, and monitoring. Subjects view 16 abstract shapes and choose a shape so that each is selected by the 16th trial and none is chosen more than once. (Eriksen, Percept Psychophysiology 1974;16:143-49).~N-Back Test of working memory. Subjects see individual letters and indicate whether the letter is the same as the nth back letter, with n equal to 1 and 2. (Dobbs, Psychol Aging 1989;4:500-3.)~Eriksen flanker task of response incompatibility. Subjects see an arrow facing either right or left and indicate the direction.The target displays can be neutral congruent, or incongruent. (Eriksen, Percept Psychophys 1974;16:143-49.)~Trail Making Test-Part B of alternating attention. Subjects connect 25 labeled circles and are scored by completion time. The lower the scores the better the performance. See details in the primary outcome.~Raw scores for each test were converted to z-scores."|Baseline to 4 months|Participants assessed at 4 months -- note some dropouts occurred|||z-scores (e.g. SD units)||Standard Error|Mean
1226907|NCT00688155|Primary|Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests.|"6 measures of executive functioning: Self-Ordered Pointing task (24): working memory~1- and 2-Back tests (25-26): working memory Eriksen flanker (27): response inhibition Task Switching (28): attentional flexibility Trail Making (29): executive function z-score=(raw score-mean)/standard deviation 4 measures of episodic memory Hopkins Verbal Learning Test (30) Wechsler Memory Scale-III (31)~A composite of 10 scores: dividing each’s difference from the baseline mean by the baseline SD, averaging the 6 executive function and 4 episodic memory z-transformed measures, and norming to have SD 1.~24. Petrides. Neuropsych 1982;20:249-62. 25. Dobbs. Psychol Aging 1989;4:500-3. 26. Jonides. J Cog Neurosci 1997;9:462-75. 27. Ericksen. Br J Sports Med 2009;43:22-4. 28. Kramer. Acta Psychologica 1999;101:339-78. 29. Reitan. Per Motor Skills 1958;8:271-6. 30. Brandt. Clin Neuropsych 1991;5:125-42. 31. Wechsler D.1997. Psychological Corporation, Harcourt, Inc: San Antonio."|Changes from baseline at 4 months in z-scores.|Participants assessed at four months post-randomization. Note that this does not include all who were randomized due to dropout.|||z-scores (e.g.Standard Deviation Units)||Standard Error|Mean
1226908|NCT00688103|Primary|Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score|"The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively.~Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet.~For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, <50% of the original joint space; 3=general, >50% of the original joint space or subluxation; 4=ankylosis."|at 52 weeks||||units on a scale||Standard Deviation|Mean
1226909|NCT00688103|Primary|ACR50 Response Rate|ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).|at 24 weeks||||percentage of responders|||Number
1226910|NCT00688103|Primary|EULAR Good Response|EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by > 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 < 3.2 is regarded as low disease activity.|at 24 weeks||||percentage of responders|||Number
1226911|NCT00688064|Secondary|Percent of Subjects With Adverse Events|Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)|Up to 12 weeks|ITT|||% of subjects|||Number
1226912|NCT00688064|Secondary|Success Rate on the Investigator's Global Assessment|"Percentage of subjects graded Clear or Almost Clear on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12"|Week 12|ITT, LOCF|||% of subjects|||Number
1226913|NCT00688064|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12||Week 12|ITT, LOCF|||% of change||Full Range|Median
1226914|NCT00688064|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.||Week 12|ITT, LOCF|||% of change||Full Range|Median
1226915|NCT00688064|Primary|Percent Change From Baseline in Total Lesion Counts at Week 12.||Week 12|ITT, LOCF|||% of change||Full Range|Median
1226916|NCT00687973|Secondary|Change From Baseline of Pulse Pressure at Week 24 (Office BP)||Baseline and Week 24|ITT Population|||mmHg||Standard Deviation|Least Squares Mean
1226917|NCT00687973|Secondary|Change From Baseline of SBP/DBP at Week 24 (Office BP)||Baseline and Week 24|ITT Population|||mmHg||Standard Error|Least Squares Mean
1226918|NCT00687973|Secondary|Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)||Baseline and Week 24|ITT Population|||mmHg||Standard Error|Least Squares Mean
1226919|NCT00687973|Secondary|Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)|Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.|Baseline and Week 24|ITT population|||mmHg||Standard Error|Least Squares Mean
1226920|NCT00687973|Secondary|Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||m/s||Standard Error|Least Squares Mean
1226921|NCT00687973|Secondary|Change From Baseline of Aix Corrected to Heart Rate at Week 24|The heart rate correction was computed by a multivariate model analysis|Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||Ratio||Standard Error|Least Squares Mean
1226922|NCT00687973|Secondary|Change From Baseline of Aix at Week 24||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||Ratio||Standard Error|Least Squares Mean
1227186|NCT00686166|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.|Only adverse events that are possibly, probably or definitely related to study regimen are reported.|Up to 4 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
1226923|NCT00687973|Secondary|Change From Baseline of Augmentation Index (Aix) at Week 8|To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.|Baseline and Week 8|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||Ratio||Standard Error|Least Squares Mean
1226924|NCT00687973|Secondary|Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||mmHg||Standard Error|Least Squares Mean
1226925|NCT00687973|Secondary|Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)||Baseline and Week 8|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||mmHg||Standard Error|Least Squares Mean
1226926|NCT00687973|Primary|Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||mmHg||Standard Error|Least Squares Mean
1226927|NCT00687908|Secondary|Percent of Subjects With Adverse Events|All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent|Up to 24 weeks||||percent of subjects|||Number
1226928|NCT00687908|Secondary|Investigator Global Assessment (IGA) Maintenance Success at Week 24|"IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.~IGA grade:~0 Clear:Residual hyperpigmentation & erythema may be present~Almost Clear:A few scattered comedones & a few small papules.~Mild:Some comedones & some papules and pustules. No nodules present~Moderate:Many comedones, papules & pustules. One nodule may be present~Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present~Very severe:Highly inflammatory acne covering the face; with nodules & cysts present"|Baseline, Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)|||percent of subjects|||Number
1226929|NCT00687908|Secondary|Maintenance Success for Non-inflammatory Lesions at Week 24|Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.|Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)|||percent of subjects|||Number
1226930|NCT00687908|Secondary|Maintenance Success for Inflamatory Lesions at Week 24|Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.|Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)|||percent of subjects|||Number
1226931|NCT00687908|Primary|Maintenance Success for Total Lesions at Week 24|Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.|Week 24|ITT - Worst-case (Any missing data at Week 24 is considered as a failure)|||percent of subjects|||Number
1226932|NCT00687856|Secondary|Refine and Test Feedback Control Algorithm That Allows Precise Prescription of Cardiac Loading Through Synchronized and Asynchronized LVAD Operation With Native Left Ventricular Contraction||Measured at Year 3|||||||
1226933|NCT00687856|Primary|Number of Subjects With Left Ventricular Recovery and LVAD Explant|Noninvasive determination of left ventricular function using novel echocardiographic imaging methods and routine clinical assessments to optimize markers of left ventricular recovery. These markers would determine LVAD patients with cardiac recovery who no longer needed LVAD support.|Number of participants who had LV recovery and LVAD explant over 3 years.|The outcome measured were the number of patients who had cardiac recovery and who no longer required LVAD support and had successful LVAD explant. Of 211 LVAD recipients, there were 8 who had successful LVAD explant|||Participants|||Count of Participants
1226934|NCT00687830|Secondary|Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.|Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.|An hour before the colonoscopy procedure||||participants|||Number
1226935|NCT00687830|Primary|Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.||Within 1 hr after the colonoscopy procedure||||units on a scale||Standard Deviation|Mean
1226936|NCT00687804|Secondary|Extension Study: Mean Change From Core Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.|Core baseline (Day 1 of the core study), Month 36 (end of extension study)|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Letters||Standard Deviation|Mean
1226937|NCT00687804|Secondary|Extension Study: Mean Change From Extension Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.|Extension baseline (Month12 -end of core study), Month 36 (end of extension study)|Participants from the Safety Population that included all participants who entered the extension and who had at least one safety assessment in the extension study with data available for analyses. Participants were grouped according to the treatment assigned in the Core study.|||Letters||Standard Deviation|Mean
1226938|NCT00687804|Primary|Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study|"Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Percentage of participants|||Number
1226939|NCT00687804|Secondary|Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 36 Months of the Core and Extension Studies|"Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about Adverse Events can be found in the Adverse Event section."|Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Percentage of participants|||Number
1226940|NCT00687804|Secondary|Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 36 Months of the Core and Extension Studies|"Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Percentage of participants|||Number
1226941|NCT00687804|Primary|Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study|"Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Percentage of participants|||Number
1226942|NCT00687804|Secondary|Core Study: Mean Change From Baseline in Patient-reported Visual Functioning|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient’s subjective assessment of vision-related quality of life. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline to Month 12|The number analyzed is the Full Analysis Set, including the number of patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.|||Units on a scale||Standard Deviation|Mean
1226943|NCT00687804|Secondary|Core Study: Mean Change From Baseline at Month 12 in Central Retinal Thickness of the Study Eye|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation.|Baseline to Month 12|The number analyzed is the Full Analysis Set, including patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.|||Micrometers||Standard Deviation|Mean
1226944|NCT00687804|Secondary|Core Study: Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline to Month 12|Full analysis set, utilizing last observation carried forward.|||Letters||Standard Error|Mean
1226984|NCT00687531|Secondary|Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)|Participants were to record their daily AM and PM PEFR values in a diary. PEFR can be measured using a peak flow meter that was given to the participant. Normal readings are based on a person's gender, age, and height. A reading of 80 to 100% of the usual or normal peak flow readings indicate that the asthma is under good control. Increased PEFR indicates improvement in asthma control.|Day 1 and Week 12|study completers (per protocol population)|||Liters/minute||Standard Deviation|Mean
1226945|NCT00687804|Secondary|Core Study: Categorized Change in Visual Acuity (Letters) of the Study Eye From Baseline at Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline to Month 12|Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.|||Participants|||Number
1226946|NCT00687804|Primary|Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline through the end of study (Month 12)|Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.|||Letters||Standard Deviation|Mean
1226947|NCT00687713|Secondary|Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use|The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.|30 days||||Participants|||Count of Participants
1226948|NCT00687713|Primary|Number of Subjects Showing Abstinence|The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.|Weeks 11 and 12||||Participants|||Count of Participants
1226949|NCT00687674|Secondary|Change in VEGF Expression Levels and Correlation With Clinical Outcomes (Phase II)||Post treatment|||||||
1226950|NCT00687674|Secondary|Percentage of Stained Circulating Endothelial Cells and Endothelial Progenitor Cells and Correlation With Clinical Outcomes (Phase II||Post treatment|||||||
1226951|NCT00687674|Secondary|Plasma Cell Gene Expression Profiles and Correlation With > Clinical Outcomes||Post treatment|||||||
1226952|NCT00687674|Secondary|Change in Apoptosis Rate From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)||Pre and Post treatment (up to 3 years)|||||||
1226953|NCT00687674|Secondary|Changes in Microvessel Density From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)||Pre and Post treatment (up to 3 years)|||||||
1226954|NCT00687674|Secondary|Time to Disease Progression (Phase II)|"Time to disease progression (TTP) was defined as the time from registration to progression. The median TTP with 95%CI was estimated using the Kaplan Meier method.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|From registration to progression (up to 3 years)|No participants proceeded to Phase II for evaluation.||||||
1226955|NCT00687674|Secondary|Overall Survival (Phase II)|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 2 years from registration. The median OS with 95%CI was estimated using the Kaplan Meier method|From registration to death (up to 3 years)|No participants proceeded to Phase II for evaluation.||||||
1226956|NCT00687674|Primary|Number of Participants Who Achieve a Confirmed Response (Partial Response [PR], Very Good PR [VGPR], Complete Response [CR], or Stringent CR [sCR]) (Phase II)|"Response that was confirmed on 2 consecutive evaluations during treatment~CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)~sCR: CR plus normal FLC ratio & absence of clonal cells in BM~VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Duration on Treatment (up to 3 years)|No participants proceeded to Phase II for evaluation.||||||
1226957|NCT00687674|Primary|Number of Participants With a Grade 3 and 4 Adverse Event (Phase I)|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|up to 3 years|One participant refused further treatment prior to being assessed for adverse events.|||participants|||Number
1226958|NCT00687609|Secondary|C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4|Participants rate most common and most severe ideation type by frequency (1=<once per week/5=many times/day), duration (1=fleeting/5=>8 times per hour persistent, continuous), controllability (1=easily able to control thoughts/8=no attempt), deterrents to active attempts (1=deterrent definitely stopped you/8=N/A, wish to die only), and reason for ideation (1=completely for attention/revenge/reaction/5=completely to stop the pain). Only items with yes responses at a given week are listed. A participant could have a yes response in more than one item.|Week 4|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Participants|||Number
1226985|NCT00687531|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Spirometry was performed to measure FEV1, which is the amount of air the participant is able to exhale in 1 second. Normal values for FEV1 in healthy people depend on age and gender, but values between 80% and 120% of the normal value is considered good. Increased FEV1 indicates improvement in asthma control.|Day 1 and Week 12|study completers (per protocol population)|||Liters||Standard Deviation|Mean
1226986|NCT00687453|Secondary|Any Adverse Event Other Than Hypoglycemia||6 months|||||||
1226987|NCT00687453|Secondary|Total Daily Insulin Dose||6 months|||||||
1226959|NCT00687609|Secondary|C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts|Solicits suicide-related information with structured questioning. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses at a given week are listed.|Week 4|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Participants|||Number
1226960|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task|For the Time Reproduction Task participants need to reproduce the duration of a visual stimulus (lightbulb) by pressing a button. The intervals vary between 2 – 20 seconds. The performance of this task takes about 15 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Milliseconds||Standard Deviation|Mean
1226961|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task|For the Contingency Task participants estimate the duration of a time interval of 1 second by pushing a button. Responses that are within a dynamic time interval are being classified as correct. This way, 50 % of the responses are correct, 50% incorrect. Three contingency conditions: neutral, reward and response cost. The performance of this task takes about 15 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Milliseconds||Standard Deviation|Mean
1226962|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task|Consists of 2 types of trials: go trials and stop trials. Go trials require participants to locate the position of an aircraft displayed to the left or right of a fixation point on a computer screen by pressing a left or right button. In 25% of the go stimili an additional stop stimulus (auditory signal) is presented shortly after the go stimulus. Participant then needs to inhibit their response. By varying the time period between go and stop stimulus, 50% of the trials are inhibited successfully, 50% not. The latency of inhibition is estimated. This task takes about 25 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Milliseconds||Standard Deviation|Mean
1226963|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)|The MCQ is a 12-item self-rated questionnaire to assess cannabis craving with 4 factors: compulsivity (an inability to control marijuana use), emotionality (use of marijuana in anticipation of relief from withdrawal/negative mood), expectancy (anticipation of positive outcomes from smoking marijuana) and purposefulness (intention and planning to use marijuana for positive outcomes). Scores are calculated on a 7-point scale (1=strongly disagree; 7=strongly agree). A separate score is calculated for each factor; scores range from 3-21 each with higher scores indicating greater craving.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1226964|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)|The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1226965|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1226966|NCT00687609|Secondary|Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version|The Global Impression of Perceived Difficulties (GIPD) scale is a five-item rating of ADHD-related difficulties. For each item, difficulties during the past week are rated on a 7 point scale (1=normal, not difficult at all; 7= extremely difficult). The GIPD total score is the sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. The scale is completed by the participant.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1226967|NCT00687609|Secondary|Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)|12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1226988|NCT00687453|Secondary|Body Mass Index Change From Baseline||6 months|||||||
1226989|NCT00687453|Secondary|Frequency of Severe Hypoglycemic Reactions||6 months|||||||
1226968|NCT00687609|Primary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher scores indicate greater impairment. The scale is scored by an investigator while interviewing the parent.|12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1226969|NCT00687544|Secondary|Number of Participants Experiencing Adverse Events|An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.|Throughout the study (up to 72 weeks)||||participants|||Number
1226970|NCT00687544|Secondary|Number of Participants Who Died||Throughout the study (up to 72 weeks)||||participants|||Number
1226971|NCT00687544|Primary|Number of Participants Who Achieved Sustained Biochemical Response (SBR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72).~The study was terminated due to low enrollment. This analysis was not performed."|Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)|||||||
1226972|NCT00687544|Secondary|Number of Participants Experiencing Opportunistic Infection|The study was terminated due to low enrollment. This analysis was not performed.|Throughout the study (up to 72 weeks)|||||||
1226973|NCT00687544|Primary|Number of Participants Who Achieved Virologic Response (VR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~The study was terminated due to low enrollment. This analysis was not performed."|24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)|||||||
1226974|NCT00687544|Primary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72).~The study was terminated due to low enrollment. This analysis was not performed."|Week 48 or Week 72 (depending on duration of treatment)|||||||
1226975|NCT00687531|Secondary|Number of Participants With Use of Rescue Medication in Each Episode||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||episodes||
1226976|NCT00687531|Secondary|Number of Participants Who Adhered to Treatment|The compliance was measured via medication consumption. In the end of the last week of study (Week 12), a review of the remaining study drug in the initial prescribed Twisthaler device was done. A Twisthaler reading of 0 indicates no study drug left and full compliance.|Day 1 to Week 12|study completers (per protocol population)|||participants|||Number
1226977|NCT00687531|Secondary|Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations|Exacerbation severity will be characterized based on exacerbation classification from the Global Initiative for Asthma (GINA) workshop 2005 and the National Heart Lung and Blood Institute (NHLBI) asthma guidelines.|Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||||
1226978|NCT00687531|Secondary|Patient’s Assessment of Response to Therapy Based on a 5-point Scale|A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).|Baseline, Week 12|This analysis was not performed due to missing data at the sites.||||||
1226979|NCT00687531|Secondary|Investigator’s Assessment of Response to Therapy Based on a 5-point Scale|The investigator will assess the subject's response to therapy by interviewing the subject and comparing the current level of symptoms from baseline. A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).|Baseline, Week 12|This analysis was not performed due to missing data at the sites.||||||
1226980|NCT00687531|Secondary|Number of Puffs of Salbutamol Used Daily||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||||
1226981|NCT00687531|Secondary|Number of Nocturnal Awakenings||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||||
1226982|NCT00687531|Secondary|Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).|The symptoms of cough, chest tightness, wheezing, and shortness of breath were each to be graded on a scale of 0 to 3 with 0 being no symptoms present and 3 being very marked symptoms which was disturbing most of the time. Scores were to have been recorded at 12AM and 12PM for a total of 24 points summed.|Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||||
1226983|NCT00687531|Secondary|Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint|"Questionnaires consisted of items such as General Health Condition (excellent/very good/good/regular/bad), Difficulty to Breathe (always/almost always/considerable part of time/partially/few amount of time/almost never/never), General Asthma Limitations (completely/a lot/enough to be considered/regular/a few/almost nothing/nothing), etc...~The questionnaires together consisted of 44 questions, each question with categorical variables as response. A Friedman test was performed to determine the significance of change in samples from baseline to endpoint, for each question."|Day 1 and Week 12|study completers (per protocol population)|||questions|questions||Number
1226990|NCT00687453|Secondary|Frequency of Total Hypoglycemic Reactions||6 months|||||||
1226991|NCT00687453|Secondary|Frequency of Pre-supper Glucose Readings 120 mg/dL or Less||6 months|||||||
1226992|NCT00687453|Primary|Hemoglobin A1c Change From Baseline||Baseline to 6 months|ITT (LOCF)|||Percent||Standard Deviation|Mean
1226993|NCT00687440|Primary|Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.|Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.|Intent-to-treat population|||Participants|||Number
1226994|NCT00687401|Primary|Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score|"PASI 75 response is defined as participants who achieved at least a~75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."|10 weeks|"Intent to Treat Population (ITT): 159 participants out of the 215 enrolled patients who received at least one dose of the study drug.~Per Protocol Population (PP): 138 participants not withdrawn from the study due to major protocol violation and who have received the three infusions of the study drug planned by the protocol."|||Participants|||Number
1226995|NCT00687362|Primary|Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10|"PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10.~The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."|10 weeks||||participants|||Number
1226996|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by Functional Assessment of Cancer Therapy (FACT)-G|The FACT-G was a 27-item questionnaire developed to assess the QoL in patients with chronic illnesses. Scores ranged from 0 to 28. For physical well being, lower scores indicated a better outcome. For functional well being, higher scores indicated a better outcome. For social & emotional well being, whether a high score or a lower one indicated a better outcome depended on the question.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.||||||
1226997|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by EORTC QLQ-LC13|The EORTC QLQ-LC13 was a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It had a score range 0-100 with higher scores representing an increase in symptoms.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.||||||
1226998|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30|The EORTC QLQ-C30 was a 30-item questionnaire developed to assess the QoL of cancer patients. Scores ranged from 0 -100. For functional and global QoL scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.||||||
1226999|NCT00687323|Secondary|Progression-free Survival for Participants Achieving PR, MLSF, or MR|Progression-free survival was defined as time to disease progression. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts.|Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) who achieved PR, MLSF, or MR|||months||95% Confidence Interval|Median
1227000|NCT00687323|Secondary|Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity|Toxicity was defined as any adverse event experienced by a participant regardless of causal relationship with study treatment. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. Adverse events may have included the onset of new illness and/or the exacerbation of preexisting conditions.|From first dose to 30 days after last dose of study drug (up to 67 weeks)|Number of participants who achieved CR, PR, or MLFS and received modified low dose maintenance therapy|||participants|||Number
1227001|NCT00687323|Secondary|MGMT Expression in Leukemic Blasts at the Time of Relapse|"Low MGMT expression was defined as MGMT/β-actin ratio of <0.2.~MGMT & β-actin are cancer biomarkers."|Up to 1 year after treatment ends (up to 115 weeks)|Analysis could not be performed due to lack of specimens.||||||
1227002|NCT00687323|Secondary|Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression|Low MGMT expression was defined as MGMT/β-actin ratio < 0.2. MGMT & β-actin are cancer biomarkers.|Baseline|All screened participants|||participants|||Number
1227003|NCT00687323|Secondary|Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|"OS was defined as the time from start of treatment until death or end of study.~Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent."|Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)|||months||95% Confidence Interval|Median
1227004|NCT00687323|Secondary|Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|Relapse-free survival was defined as time to disease progression. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.|Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)|||months||95% Confidence Interval|Median
1227005|NCT00687323|Secondary|Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.|Up to 1 year after treatment ends (up to 115 weeks)|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)|||Days||Full Range|Median
1227006|NCT00687323|Primary|Clinical Response at the End of Temozolomide Induction|"Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.~CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.~Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met.~Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts."|at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)|||participants|||Number
1227007|NCT00687297|Secondary|Progression-free Survival|Time from randomization to first evidence of disease progression or death. Patients alive without progression are censored at the date of last disease evaluation.|every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance)|All randomized patients were included.|||months||95% Confidence Interval|Median
1227008|NCT00687297|Secondary|Objective Response Rate|Best overall response (complete or partial response), assessed using RECIST criteria (version 1.0)|Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))|All randomized patients were included.|||percentage of participants||95% Confidence Interval|Number
1227009|NCT00687297|Primary|Progression-free Survival|Time from randomization (prior to induction) to first evidence of disease progression or death without progression. Participants alive without progression were censored at the date of last disease evaluation.|Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))|All randomized patients were included.|||Months||95% Confidence Interval|Median
1227010|NCT00687271|Secondary|Percentage Change From Baseline in TG|Blood collected at baseline (predose) and after 4 weeks of treatment to determine TG levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage of Participants||95% Confidence Interval|Median
1227011|NCT00687271|Secondary|Percentage Change From Baseline in HDL-C|Blood collected at baseline (predose) and after 4 weeks of treatment to determine HDL-C levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1227012|NCT00687271|Secondary|Percentage Change From Baseline in Total Cholesterol (TC)|Blood collected at baseline (predose) and after 4 weeks of treatment to determine TC levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1227013|NCT00687271|Secondary|Percentage Change From Baseline in Apolipoprotein B (ApoB)|Blood collected at baseline (predose) and after 4 weeks of treatment to determine ApoB levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1227014|NCT00687271|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Blood collected at baseline (predose) and after 4 weeks of treatment to determine non-HDL-C levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1227015|NCT00687271|Secondary|Percentage of Participants That Had Study Drug Discontinued Due to an AE|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.|up to 4 weeks|All participants that received at least 1 dose for study drug.|||Percentage of Participants|||Number
1227016|NCT00687271|Secondary|Percentage of Participants Who Experience at Least 1 Adverse Event (AE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized|Up to 14 days post last dose of study drug (up to 6 weeks)|All participants that received at least 1 dose for study drug.|||Percentage of Participants|||Number
1227017|NCT00687271|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1227018|NCT00687219|Secondary|Number of Participants With Undetectable HCV-RNA at End of Treatment|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Up to 48 weeks||||Participants|||Number
1227058|NCT00687076|Secondary|Change in Total Cholesterol (mg/dl) From Baseline to Month 12|Lipids: Total cholesterol (mg/dl); Lipid Data at 12-Months (change from baseline) [mg/dl].|Measured at baseline and 12 months|All values are medians and interquartile range (IQR). P-values were calculated with the KruskaleWallis rank test.|||mg/dl||Inter-Quartile Range|Median
1227019|NCT00687219|Secondary|Number of Participants With Undetectable HCV-RNA at Week 24|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Week 24|Peginterferon alfa-2b administered at 1.0 μg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks|||Participants|||Number
1227020|NCT00687219|Primary|Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Measured at 24 weeks after 48 weeks treatment (72 weeks)||||Participants|||Number
1227021|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227022|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227023|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227024|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227025|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227026|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change =score at Week 12 minus score at baseline"|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227027|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227028|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227029|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227030|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227031|NCT00687193|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227032|NCT00687193|Secondary|Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)|ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1227033|NCT00687193|Secondary|Change From Baseline in C- Reactive Protein (CRP) (mg/L)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||mg/L||Standard Error|Least Squares Mean
1227034|NCT00687193|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritis|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227035|NCT00687193|Secondary|Change From Baseline in Patient’s Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227036|NCT00687193|Secondary|Change From Baseline in Patient’s Assessment of Pain|"Change from Baseline in Patient’s Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement.~Change = value at observation minus value at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227037|NCT00687193|Secondary|Change From Baseline in Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||units on a scale||Standard Error|Least Squares Mean
1227038|NCT00687193|Secondary|Change From Baseline in Painful and Tender Joint Counts|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.|Baseline, Weeks 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||units on a scale||Standard Error|Least Squares Mean
1227039|NCT00687193|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|"HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.~Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227040|NCT00687193|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]|"The DAS28-4 (ESR) score is a measure of the participant’s disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant’s global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.~Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227041|NCT00687193|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]|"The DAS28-3 (CRP) score is a measure of the perticipant’s disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.~Change = value at observation minus value at baseline"|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
1227042|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
1227043|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
1227044|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
1227045|NCT00687193|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP)at each visit.|Week 2, 4, and 8|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
1227046|NCT00687193|Primary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
1227047|NCT00687167|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
1227048|NCT00687167|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.||||ng/mL||Standard Deviation|Mean
1227049|NCT00687102|Secondary|Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group|"Mean Change From Baseline on the Geriatric Depression Scale. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures depression in older adults. Mood is also assessed with the 15-item short form of the GDS which measures non-somatic features of depressed mood. Participants indicate the presence or absence of each symptom. The GDS-SF score is the total number of positive depressive items. Score range is 0-15, with 0-4 denoting better outcomes and a score of 5 and above denoting worse outcomes (depression)."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||units on a scale||Standard Error|Mean
1227050|NCT00687102|Secondary|Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group|"Mean Change From Baseline on the Positive and Negative Affect Schedule (PANAS). Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures positive and negative affect. Mood is assessed with the PANAS, a list of ten pleasant mood states (e.g., interested, proud, inspired) and ten unpleasant mood states (e.g., irritable, guilty, jittery). Respondents are asked to rate on a 5-point scale (1 being very slightly or not at all and 5 being extremely) the extent to which they have experienced each mood during a specific time frame. Ratings for each item can range from 0 to 4 with total scores for positive affect and negative affect subscales ranging from 0 to 40. For positive affect, higher scores denote higher levels of positive affect and for negative affect, lower scores denote lower levels of negative affect."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||units on a scale||Standard Error|Mean
1227051|NCT00687102|Secondary|Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group|"Mean Change From Baseline on the the Finger Tapping Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures motor speed, coordination, attention, alertness, slowing of responses, and motor control. In this test of motor speed and dexterity participants are asked to depress a lever as many times as possible in each of 7, 10-second trials, first with the right hand and next with the left hand. The highest and lowest scores are dropped; the score is the average of the remaining five trials for each hand.Higher scores represent better outcomes."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||finger taps||Standard Error|Mean
1227052|NCT00687102|Secondary|Mean Change From Baseline on Card Rotations Test Scores by Treatment Group|"Mean Change From Baseline on the Card Rotations Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures the ability to mentally manipulate figures in two and three-dimensions. On each of 28 trials, participants view sample line drawings of a geometric figure and 8 alterations representing 2 or 3-dimensional rotations of the drawing. Participants are asked to identify alternatives that show the sample in 2-D but not in 3-D. Total range 0 – 160 and the number of incorrect/correct responses is measure. Higher number of correct answers is a better outcome."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||correct responses||Standard Error|Mean
1227053|NCT00687102|Secondary|Mean Change From Baseline on Digit Span Test Scores by Treatment Group|"Mean Change From Baseline on the Digit Span Test - Digits Forward and Digits backward Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures reasoning, verbal ability, and memory. The participant is asked to provide immediate recall of a series of digits in forward and backward sequences. The individual's score is the total number of items correctly repeated forwards or backwards. Total range 0 – 14, higher results denotes a better outcome."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||units on a scale||Standard Error|Mean
1227054|NCT00687102|Secondary|Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group|"Mean Change From Baseline on the Letter Fluency Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures cognitive function. In this test, the participant names as many words as possible in 1 minute, beginning with each letter for letter fluency (F, A, and S) and category for semantic fluency (fruits and vegetables). To score the administrator, counts up the total number letters or words that the individual is able to produce. The score minimum would be 0 and the maximum would be the total of correct items named within 1 minute. Higher scores represent better outcomes."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||change in number of words||Standard Error|Mean
1227055|NCT00687102|Primary|Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group|"Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~The experimenter reads a list of 16 nouns aloud, at one-second intervals, in fixed order, over 3 learning trials (list A) . After each trial, the subject is asked to recall as many words as they can in any order (i.e., free recall) given a score 0-16 each. Total range as the sum of the 3 learning trials: 0 – 48. Participants were asked to recall a second interference list (List B) with a score range of 0-16. Free recall of list A are tested immediately after list B (short-delay) Total range 0- 16 , and again after 20 minutes (long-delay) 0-16. Each part of the scale is reported separately as Total List A trials, Total List B trials, Short-delay free recall, and Long-delay free recall."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||correct responses||Standard Error|Mean
1227056|NCT00687102|Primary|Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group|"Mean Change From Baseline on the Benton Visual Retention (BVRT) Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~The BVRT measures short term visual memory and visuo-constructional abilities. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score on the BVRT is the total number of errors, 0-26 represents the total number of theoretically possible errors. Lower score denotes better outcomes."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||Number of errors||Standard Error|Mean
1227057|NCT00687076|Secondary|Effect of Intensive Lipid Modification Medication Therapy on Thrombosis, and Relationship to PAD Progression, Restenosis, and Clinical Events||Measured at baseline and Months 6, 12, and 24|||||||
1227059|NCT00687076|Primary|Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis|"The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed.~Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4)."|Measured at baseline and Months 6, 12, and 24|Multilevel models were used to describe changes over time in the MRI outcome variables and to compare the drug therapy groups. The advantage of multilevel models is the capability to use data with missing or irregularly timed observations, due to death or loss to follow-up, on the outcome variable.|||mm^3, at 24-months||Standard Error|Mean
1227060|NCT00686998|Primary|Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline|PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.|Baseline, Day 28||||Points on a scale||Standard Error|Mean
1227061|NCT00686972|Primary|Insulin Secretion||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.||||||
1227062|NCT00686959|Secondary|Percentage of Participants With a Post Baseline Swallowing Diary Score >=4|Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.|Baseline through 30 Days Post Study|All randomized participants with at least one post baseline swallowing diary score.|||percentage of participants||95% Confidence Interval|Number
1227063|NCT00686959|Secondary|First Site of Disease Failure in Terms of Relapse|The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.|Baseline to Relapse (Up to 66.6 Months)|All randomized participants with objective PD.|||percentage of participants||95% Confidence Interval|Number
1227064|NCT00686959|Secondary|Survival Rates at 1, 2, and 3 Years|The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.|Baseline to Date of Death from Any Cause (Up to 71.4 Months)|All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.|||probability of survival||95% Confidence Interval|Number
1227065|NCT00686959|Other Pre-specified|Adverse Events: The Number of Deaths Per Treatment Group|The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 30 Days Post Study|All randomized participants who received at least one dose of study drug.|||participants|||Number
1227066|NCT00686959|Secondary|Objective Response Rate (Complete Response [CR] + Partial Response [PR])|Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline to Measured Progressive Disease (Up to 7 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1227067|NCT00686959|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)|All randomized participants. Arm A had 99 participants censored and Arm B had 87 participants censored.|||months||95% Confidence Interval|Median
1227187|NCT00686166|Secondary|3-year Disease-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|3 years|Eligible and analyzable patients|||percentage of participants||95% Confidence Interval|Number
1227068|NCT00686959|Primary|Overall Survival|Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.|Baseline to Date of Death from Any Cause (Up to 71.4 Months)|All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.|||months||95% Confidence Interval|Median
1227069|NCT00686894|Primary|The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software.|Two measures were to be used for each enthesis evaluation. 1.) Vascularization: yes/no. 2.) Area of hyper-vascularization: mm^2 (continuous) using proprietary software. This study was terminated early due to slow recruitment. As a result, efficacy analyses were not performed.|8 weeks||||Number of Enthesitis|||Number
1227070|NCT00686881|Secondary|Number of Participants With Change in Metavir Inflammation Score|Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).|Baseline and Week 48|All treated participants excluding 3 participants on the PegIFN-2b arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.|||Participants|||Number
1227071|NCT00686881|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration|The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.|Week 24|All treated participants except 1 SNMC participant who had no available data after initial treatment.|||Participants|||Number
1227072|NCT00686881|Primary|Number of Participants With Change in Metavir Fibrosis Score|Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).|Baseline and discontinuation of treatment (up to 156 weeks)|All treated participants excluding 2 participants on the PegIFN-2B arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.|||Participants|||Number
1227073|NCT00686855|Primary|The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.|Participants were given a survey at the time of screening and 4 weeks after start of therapy. The participants self-reported three symptoms of oral cGVHD: oral sensitivity, mouth pain, and mouth dryness. Each symptom was given a score ranging from 0-10, with 0 as none and 10 as the worst. Improvement in subjective scores was defined as 3 points or further reduction from pre-treatment to post-treatment assessment.|Participants were assessed at Baseline and 4 weeks after start of therapy|Of the 46 participants enrolled on the trial, 36 were deemed evaluable for response.|||participants|||Number
1227074|NCT00686842|Secondary|Effects of Study Drug on Viral Gene Expression and Cellular Gene Transcription, as Measured by Real-time Quantitative PCR-based Profiling, in Tumor Biopsy Samples||Screening and day 28|||||||
1227075|NCT00686842|Secondary|Effects of Study Drug on VEGF, VEGFR-2 and -3, Phospho-Akt, p53, and HIF-1α Expression and Tumor Cell Proliferation, as Measured by Ki-67 Staining, in Tumor Biopsy Samples||Screening and day 28|||||||
1227076|NCT00686842|Secondary|Effects of Study Drug on T-lymphocyte Subsets (i.e., CD4 and CD8)||Screening, day 29, every 3 cycles thereafter, and at treatment discontinuation|||||||
1227077|NCT00686842|Secondary|Effects of Study Drug on HIV and KSHV Viral Loads||Screening, end of cycle 1, end of every third cycle thereafter, and treatment discontinuation|||||||
1227078|NCT00686842|Secondary|Effects of Study Drug on Serum and Plasma VEGF, VEGFR, and Cytokine Profiles||On the first day of every 28-day cycle of treatment, Day 15, and treatment discontinuation|||||||
1227079|NCT00686842|Secondary|Pharmacokinetics||Days 1, 15, 28, 57|||||||
1227080|NCT00686842|Primary|Response to Treatment||After each 28-day cycle of treatment and at discontinuation of therapy|||||||
1227081|NCT00686842|Primary|Maximum Tolerated Dose||After each group of 3 subjects completes cycle 1 of treatment|||||||
1227082|NCT00686842|Primary|Safety and Toxicity of Anti-VEGF Small Molecule PTC299|Patients who experienced an adverse event of grade 3 or greater|All study visits||||participants|||Number
1227083|NCT00686803|Primary|Pharmacodynamics as Measured by cGMP Levels.|"Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax~The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible."|24 hours||||ng/mL||Full Range|Median
1227084|NCT00686803|Primary|Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.|"The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach.~•Maximum concentration (Cmax)~The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible."|24 hours||||ng/mL||Standard Deviation|Mean
1227085|NCT00686790|Secondary|Number of Participants With a Liver Histology Response|"The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies.~The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT."|Baseline and 52 week (EOT)|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.|||Participants|||Number
1227086|NCT00686790|Primary|Number of Participants With a Combined Response|"The combined response was defined as an ALT level below the upper~reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L."|52 weeks (EOT), 104 weeks (EOF)|"The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.~2 participants with adverse events (AE) that had protocol violations have been included in the analysis."|||Participants|||Number
1227087|NCT00686790|Primary|Number of Participants With a Biochemical Response|A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.|52 weeks (EOT), 104 weeks (EOF)|"The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.~2 participants with adverse events (AE) that had protocol violations have been included in the analysis."|||Participants|||Number
1227088|NCT00686790|Secondary|Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)|Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum.|52 week (EOT)|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.|||Participants|||Number
1227089|NCT00686790|Primary|Number of Participants With a Virological Response|For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).|52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.|||Participants|||Number
1227090|NCT00686777|Primary|Number of Participants Discontinuing Treatment|Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.|From time of first treatment to Week 48||||participants|||Number
1227091|NCT00686777|Secondary|Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT|HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.|Measured at 24 weeks of treatment and at EOT (Treatment week 48)|All treated Participants|||percentage of participants|||Number
1227092|NCT00686777|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation|"SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.~HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result."|Measured at 24 weeks after the end of treatment (at the end of follow-up)|All treated Participants|||percentage of participants|||Number
1227093|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group|"MGMT was measured by IHC.~PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 8."|||months||Standard Deviation|Median
1227094|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group|"MGMT was measured by IHC.~PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 9."|||months||Standard Deviation|Median
1227095|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group|"MGMT was measured by IHC.~OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment.~OS was calculated by the Kaplan-Meier method."|6, 12, & 18 months|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 6."|||percentage of participants||95% Confidence Interval|Number
1227096|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group|"MGMT was measured by IHC.~OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment.~OS was calculated by the Kaplan-Meier method."|6, 12, & 18 months|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 7."|||percentage of participants||95% Confidence Interval|Number
1227097|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group|"MGMT was measured by IHC.~OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.~OS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 4."|||months||Standard Deviation|Median
1227098|NCT00686725|Secondary|Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group|"MGMT was measured by immunohistochemistry (IHC).~OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.~OS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 5."|||months||Standard Deviation|Median
1227121|NCT00686686|Secondary|Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18.|"The Physician Static Global Assessment (PGA) documents the physician's assessment of the subject's psoriasis status according to the following categories: induration, scaling, and erythema. Each category is rated from 0 to 5, where 0 represents no evidence of induration/scaling/erythema (clear), 1 represents minimal induration/scaling/erythema, and 5 represents the most severe induration/scaling/erythema."|Weeks 12 and 18|One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16 for the Week 12 observations (but n=17 for the Week 18 observations).|||participants|||Number
1227099|NCT00686725|Secondary|Objective Tumor Assessment After Surgery: Overall Response|"Overall response was based on neuroimaging (magnetic resonance imaging [MRI]), clinical neurological examination, and steroid administration.~It was assessed as follows:~Complete Response (CR): Disappearance of all enhancing tumor (measurable~or non-measurable), no corticosteroid use, and neurologically stable or~improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor~(measurable or non-measurable) for any measurable lesions or definite~improvement for any non-measurable lesions, corticosteroid dosage stable or~reduced, and neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in contrast enhancement for any~measurable lesions or definite worsening for any non-measurable lesions, or~any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded.~Stable Disease (SD): All other situations."|Up to 2 years||||participants|||Number
1227100|NCT00686725|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years||||months||95% Confidence Interval|Median
1227101|NCT00686725|Primary|Overall Survival (OS)|"OS was defined as the time from randomization to death.~OS was calculated by the Kaplan-Meier method."|Up to 2 years||||months||95% Confidence Interval|Median
1227102|NCT00686712|Secondary|Any Adverse Event Other Than Hypoglycemia|Any reported adverse event that is not hypoglycemia|6 months|Enrolled subjects|||Events|||Number
1227103|NCT00686712|Secondary|Total Daily Insulin Dose|Total daily number of units of insulin used|6 months|Enrolled subjects|||Units of insulin per day||Standard Deviation|Mean
1227104|NCT00686712|Secondary|Body Mass Index Change From Baseline|Change in body mass index from baseline BMI measurement|6 months|Enrolled subjects|||kg per square meter||Standard Deviation|Mean
1227105|NCT00686712|Secondary|Frequency of Severe Hypoglycemic Reactions|Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person|6 months|Enrolled subjects|||Severe hypoglycemic events|||Number
1227106|NCT00686712|Secondary|Frequency of Total Hypoglycemic Reactions|Frequency of hypoglycemic reactions without regard to time of occurrence|6 months|Enrolled subjects|||Hypoglycemic events per patient||Standard Deviation|Mean
1227107|NCT00686712|Secondary|Frequency of Glucose Readings < 130 mg/dL|Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL|6 months|Enrolled subjects|||percentage of readings||Standard Deviation|Mean
1227108|NCT00686712|Primary|Hemoglobin A1c Change From Baseline||Baseline to 6 months|ITT (LOCF)|||Percent||Standard Deviation|Mean
1227109|NCT00686699|Secondary|Mean ESRS Part IV Subscores: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
1227110|NCT00686699|Secondary|Lowest ESRS Part IV Subscore: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
1227111|NCT00686699|Secondary|Mean ESRS Part III Subscores: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
1227112|NCT00686699|Secondary|Lowest ESRS Part III Subscore: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
1227122|NCT00686686|Secondary|Number of Participants Who Achieve a Moderate Response.|Moderate response is defined as a 50% to 75% reduction in PPPASI score from baseline.|Baseline and Week 8|It was decided that this analysis will not be done.||||||
1227252|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|24 months (approximately study days 547 - 730)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227113|NCT00686699|Secondary|Mean ESRS Part II Subscores: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
1227114|NCT00686699|Secondary|Lowest ESRS Part II Subscore: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
1227115|NCT00686699|Secondary|Mean ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
1227116|NCT00686699|Secondary|Lowest ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
1227117|NCT00686699|Secondary|Mean ESRS Total Scores Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS total score consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The mean ESRS total scores at Hours 1, 2, 3, 4, 5, and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
1227118|NCT00686699|Primary|Lowest Extrapyramidal Symptom Rating Score (ESRS) Total Score Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS total score consists of 4 subscales: 1) a questionnaire of extrapyramidal symptoms (EPS) and drug-induced movement disorders (DIMD) over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The lowest ESRS total score for each participant within the 6-hour range on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
1227119|NCT00686686|Secondary|Dermatology Life Quality Index (DLQI)|"The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a subject's QOL. It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI was completed by the subject prior to the PPPASI and PGA evaluations.~The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired."|Baseline and Week 12|One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16.|||scores on a scale||Standard Deviation|Mean
1227120|NCT00686686|Secondary|Number of Participants Who Respond to the Fourth Infusion.|>=25% reduction in PPPASI score would be considered a response.|Week 12 and Week 18|Only three participants received a fourth infusion but according to the protocol they were not suppose to receive it at that time because their improvement in PPPASI score on Week 8 was less than 75%. Therefore, because no participants qualified to be analyzed for this endpoint, no data are given.||||||
1227253|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|18 months (approximately study days 366 - 546)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227123|NCT00686686|Primary|Number of Participants Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions.|"The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. Extent is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement."|Baseline and Week 8|Per Protocol population included the 17 subjects who completed the trial.|||participants|||Number
1227124|NCT00686647|Secondary|Major Adverse Cardiac Events|cardiac death, myocardial infarction, or target lesion revascularization|9 months||||percentage of participants|||Number
1227125|NCT00686647|Secondary|Major Adverse Cardiovascular Events|cardiac death, myocardial infarction, or target lesion revascularization|30 days|intention to treat|||percentage of particpants|||Number
1227126|NCT00686647|Primary|Procedural Success|Defined as less than or equal to 30% diameter stenosis in the main branch and less than or equal to 70% diameter stenosis in the side branch at the conclusion of the procedure (including adjunctive stenting) in the absence of in-hospital major adverse cardiac events (MACE) [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR]|1 day|intention to treat|||percentage of participants|||Number
1227127|NCT00686634|Secondary|Number of Adverse Events||1 year||||Adverse event|||Number
1227128|NCT00686634|Secondary|Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year||1 year||||participants|||Number
1227129|NCT00686634|Secondary|Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months||4 months||||participants|||Number
1227130|NCT00686634|Primary|Hemoglobin A1c (HbA1c) Change From Baseline||Baseline, 4 months|Last Observation Carried Forward for subjects with paradoxical worsening of control (switched to alternate treatment before 4 months)|||percentage||Standard Deviation|Mean
1227131|NCT00686595|Secondary|Percent Reduction in SKINDEX-29 Scores at Week 24|The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from “never” (=0) to “all the time” (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the SKINDEX-29 assessments were available.|||Percent reduction||Standard Deviation|Mean
1227132|NCT00686595|Secondary|Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18|The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from “never” (=0) to “all the time” (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the SKINDEX-29 assessments were available.|||Percent reduction||Standard Deviation|Mean
1227133|NCT00686595|Secondary|Percent Reduction in DLQI Total Score at Week 24|DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the DLQI assessment was available.|||Percent reduction||Standard Deviation|Mean
1227134|NCT00686595|Secondary|Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18|DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the DLQI assessment was available.|||Percent reduction||Standard Deviation|Mean
1227135|NCT00686595|Secondary|Percent Reduction in VAS Referred Itch at Week 24|VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the VAS assessment was available.|||Percent reduction||Standard Deviation|Mean
1227136|NCT00686595|Secondary|Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18|VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the VAS assessment was available.|||Percent reduction||Standard Deviation|Mean
1227137|NCT00686595|Secondary|Percent Reduction in Affected BSA at Week 24|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant’s body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the BSA assessment was available.|||Percent reduction||Standard Deviation|Mean
1227138|NCT00686595|Secondary|Percent Reduction in Affected Body Surface Area (BSA) at Week 18|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant’s body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the BSA assessment was available.|||Percent reduction||Standard Deviation|Mean
1227139|NCT00686595|Secondary|Percent Reduction in SAPASI at Week 24|SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the SAPASI assessment was available.|||Percent reduction||Standard Deviation|Mean
1227140|NCT00686595|Secondary|Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18|SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the SAPASI assessment was available.|||Percent reduction||Standard Deviation|Mean
1227141|NCT00686595|Secondary|PASI 100 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 24 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 24.|24 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227142|NCT00686595|Secondary|PASI 100 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 18 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227143|NCT00686595|Secondary|PASI 100 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 10 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227144|NCT00686595|Secondary|PASI 90 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 24 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 24.in PASI at Week 24|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227145|NCT00686595|Secondary|PASI 90 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 18 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227146|NCT00686595|Secondary|PASI 90 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 10 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227147|NCT00686595|Secondary|PASI 50 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 24 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 24.|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227148|NCT00686595|Secondary|PASI 50 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 18 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1232664|NCT00640224|Primary|Peripheral Insulin Sensitivity at Baseline and 6 Months.|Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.|Baseline and 6 months||||mg/kg/min per uU/mL||Standard Error|Mean
1227149|NCT00686595|Secondary|PASI 50 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 10 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227150|NCT00686595|Secondary|PASI 75 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 24 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 24.|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227151|NCT00686595|Secondary|PASI 75 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 18 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percent of participants|||Number
1227152|NCT00686595|Primary|Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the intent-to-treat (ITT) population for whom the PASI assessment was available.|||Percentage of participants|||Number
1227153|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||Participants|||Number
1227154|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15|Individual mean concentrations calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||Participants|||Number
1227155|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 3 and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||Participants|||Number
1227156|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 3 and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||Participants|||Number
1227157|NCT00686543|Primary|Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||ng/mL||90% Confidence Interval|Mean
1227158|NCT00686543|Primary|Mean POS Plasma Concentrations on Days 2, 3, and 8.|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||ng/mL||90% Confidence Interval|Mean
1227254|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|12 months (approximately study days 271 - 365)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227160|NCT00686517|Secondary|Number of Participants With Rapid Virologic Response (RVR)|"Participants were considered to have RVR if serum HCV RNA level at 2 or 4~weeks of treatment was below the cut off value of the referring local~laboratory of each participating site."|Evaluated at 2 and 4 weeks of treatment|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
1227161|NCT00686517|Secondary|Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization|ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.|Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
1227162|NCT00686517|Secondary|Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).|LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.|At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
1227163|NCT00686517|Secondary|Virologic Response at the End of Treatment Follow-up (ETR)|"ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks~treatment (depending on treatment arm) was <15 IU/mL."|At the end of treatment (either 12 weeks or 24 weeks depending on randomization).|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
1227164|NCT00686517|Primary|Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period|SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.|Evaluated at the end of 6 months|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
1227165|NCT00686374|Secondary|Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time|The CDAI includes 8 variables: participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. Participants kept track of daily symptoms on a diary card, and the scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease) and > 450 (severely active disease). A CDAI was calculated at each visit for those who were ≥ 13 years old at Study M06-806 entry. The baseline value was defined as the last non-missing value on or before the date of the first dose of study drug in Study M06-806. Negative changes indicate reductions (improvement) in disease activity.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384|Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||units on a scale||Standard Deviation|Mean
1227166|NCT00686374|Secondary|Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The baseline value was defined as the last non-missing value on or before the date of the first dose of study drug in Study M06-806. Negative changes indicate reductions (improvement) in disease activity.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384|ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||units on a scale||Standard Deviation|Mean
1227167|NCT00686374|Secondary|Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time|The CDAI includes 8 variables encompassing subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. Participants kept track of daily symptoms on a diary card, and the scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease), and > 450 (severely active disease). A CDAI was calculated at each visit for subjects ≥ 13 years old at M06-806 entry. CDAI corticosteroid-free remission was defined as discontinued use at least 90 consecutive days prior to the respective visit and a CDAI < 150 at that visit.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384|Participants ≥ 13 years old with corticosteroid use at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
1227184|NCT00686205|Primary|PRISM HIV O Plus Test Data for Sensitivity|Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).|12 months|1,388 specimens from individuals positive for HIV antibodies and 136 specimens positive by supplemental testing from US individuals at increased risk of HIV infection or from an HIV-2 endemic area. These 1,524 specimens were used for the sensitivity calculation.|||participants|||Number
1227168|NCT00686374|Secondary|Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384|Participants with corticosteroid use at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
1227169|NCT00686374|Secondary|Number of Participants Who Were in Crohn’s Disease Activity Index (CDAI) Clinical Response Over Time|The CDAI includes 8 variables: subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight). Participants kept track of symptoms on a diary card, and scores were summed for the week. Each item is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. Scale: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease), and > 450 (severely active disease). A CDAI was calculated at each visit for participants ≥ 13 yrs old at M06-806 entry. Clinical response was defined as a decrease from M06-806 Baseline CDAI value of ≥ 70 pts. The M06-806 Baseline value was defined as the last non-missing value on or before the date of the 1st dose of study drug in M06-806.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408|Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
1227170|NCT00686374|Secondary|Number of Participants Who Were in Crohn’s Disease Activity Index (CDAI) Clinical Remission Over Time|The CDAI includes 8 variables encompassing both subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, participants kept track of daily symptoms on a diary card, and the daily symptom scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease. A CDAI was calculated at each visit for participants who were age 13 or older at Study M06-806 entry. The Study M06-806 Week 52 visit served as the baseline visit for this study.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408|Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
1227171|NCT00686374|Primary|Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The baseline PCDAI value was defined as the last non-missing value on or before the date of the first dose of study drug during Study M06-806. Clinical response was defined as a PCDAI ≥ 15 points lower than the Study M06-806 baseline PCDAI value.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408|ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
1227172|NCT00686374|Primary|Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408|ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
1227173|NCT00686335|Primary|Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment|Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra.|4 weeks and 8 weeks|The efficacy analysis population included all 7 patients who completed both study periods without major protocol deviations.|||number of nocturnal awakenings||Standard Deviation|Mean
1227174|NCT00686257|Secondary|In-hospital Mortality Rate||during hospitalization (after recruitment)||||Participants|||Count of Participants
1227175|NCT00686257|Secondary|Length of Hospital Stay||during hospitalization (after recruitment)||||Days||Full Range|Mean
1227176|NCT00686257|Secondary|Total Length of Time Requiring NIV||during hospitalization (after recruitment)||||Hours||Inter-Quartile Range|Median
1227177|NCT00686257|Secondary|Deterioration in Gas Exchange||during the first 24 hours of the study||||Participants|||Count of Participants
1227178|NCT00686257|Secondary|Deterioration Vital Signs||during the first 24 hours of the study||||Participants|||Count of Participants
1227179|NCT00686257|Secondary|Early NIV Discontinuation Rate|Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support|During hospitalization period (after recruitment into the study)||||Participants|||Count of Participants
1227180|NCT00686257|Primary|Time Required for Mask Placement||at the initiation of NPPV||||Minutes||Inter-Quartile Range|Median
1227188|NCT00686166|Primary|Pathologic Complete Response Rate|Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.|15-20 weeks from registration|Eligible and analyzable patients with available data. It was assumed that a pathologic complete response was not achieved for patients who do not receive surgery or for whom a surgical specimen is lacking. These patients were included in the denominator.|||percentage of participants||95% Confidence Interval|Number
1227189|NCT00686127|Secondary|Pain Interference With Function||12 weeks|||||||
1227190|NCT00686127|Primary|Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks|Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).|Baseline, 12 weeks|This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.|||units on a scale|||Number
1227191|NCT00686075|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.|||participants|||Number
1227192|NCT00686075|Secondary|Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization|An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.|||participants|||Number
1227193|NCT00686075|Secondary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.|||participants|||Number
1227194|NCT00686075|Secondary|Genotypic Stability of Recovered Vaccine-Type Virus|Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.|Within 28 days after any dose|Shedding population included all randomized participants who received study vaccine and had valid shedding data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nasal wash samples|Participants||Number
1227195|NCT00686075|Secondary|Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3|Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.|Day 28 after Dose 3|Immunogenicity population included all randomized participants who received study vaccine for the specified dose and had valid immunogenicity data. 'N' (number of participants analyzed) = participants evaluable for this measure; and ‘n’ = participants evaluable for specified virus type, for each group, respectively.|||percentage of participants||95% Confidence Interval|Number
1227196|NCT00686075|Secondary|Number of Participants Who Shed Vaccine-Type Virus|Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.|7, 12 and 28 days after Dose 1, 2 and 3|Shedding population included all randomized participants who received study vaccine and had valid shedding data after the specified dose. ‘N’ (number of participants analyzed) = participants who were evaluable for this measure; and 'n' = participants who were evaluable for this measure at given time points for each group, respectively.|||participants|||Number
1227197|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.|||participants|||Number
1227198|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.|||participants|||Number
1227199|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.|||participants|||Number
1227200|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.|||participants|||Number
1227201|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.|||participants|||Number
1227202|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.|||participants|||Number
1227203|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.|||participants|||Number
1227204|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.|||participants|||Number
1227205|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.|||participants|||Number
1227206|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 3|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.|||participants|||Number
1227207|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 2|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.|||participants|||Number
1227255|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|9 months (approximately study days 181 - 270)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227208|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 1|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.|||participants|||Number
1227209|NCT00686036|Secondary|Serum Testosterone Levels||Change from baseline at each visit post-randomization until until week 78|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.||||||
1227210|NCT00686036|Secondary|Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)||From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.||||||
1227211|NCT00686036|Secondary|Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)||78 weeks during off-treatment phase of ADT|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.||||||
1227212|NCT00686036|Primary|Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)||52 weeks|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.||||||
1227213|NCT00685945|Other Pre-specified|Net Glucose Uptake|Individual net reuptake rates at each time point were calculated by the following formula: net uptake = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of glucose in the brachial vein and artery, respectively.|At baseline and after maximum dose of bradykinin||||microgram/min/100ml||Standard Error|Mean
1227214|NCT00685945|Secondary|Forearm Blood Flow (FBF)|Forearm blood flow was measured by strain gauge plethysmography|During and after each study drug administration||||ml/min/100ml||Standard Error|Mean
1227215|NCT00685945|Primary|Net Tissue-type Plasminogen Activator (t-PA) Release|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively.|During and after each study drug administration|Twenty four subjects were studied. One subject was excluded because of erroneous drug administration. Analysis was per protocol. Twenty-three subjects receive bradykinin then L-NMMA plus bradykinin infusions. Subjects were then randomized to either isosorbide or sildenafil. Twelve subjects received sildenafil and 11 subjects received isosorbide.|||ng/min/100ml||Standard Error|Mean
1227216|NCT00685932|Primary|The Degree of Pain With Activity on Post-operative Day Number Two|Visual analog scale (VAS) of pain with activity on a scale of 0-15cm with 0cm: No pain to 15cm: Severe pain.|2 days||||cm||Standard Deviation|Mean
1227217|NCT00685932|Secondary|Number of Participants Who Report Asymmetrical Pain on Second Post-operative Day After Cesarean Delivery|Visual analog scale will be used to assess pain on the right or left side of the body with activity.VAS will use a 0-7.5cm range on the right and 0-7.5cm range on the left. This scale is with 0 (or central mark) as no pain and increasing as the subject marks away from the central mark.|2 days post-operation||||participants|||Number
1227218|NCT00685880|Primary|Number of Participants With a Decreased Pain Score >20%|Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.|baseline, 6 month follow-up|||||||
1227219|NCT00685802|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.|Pharmacokinetic analyses of cilostazol and Pletal® are based on 28 and 27 subjects, respectively. Reliable estimates could not be obtained for one subject administered Cilostazol and two subjects administered Pletal® because there was not a smooth decline in concentrations in the terminal phase of elimination.|||ng-hr/mL||Standard Deviation|Mean
1227220|NCT00685802|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
1227221|NCT00685802|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.||||ng/mL||Standard Deviation|Mean
1227222|NCT00685763|Secondary|Collect and Analyze Tumor Control Measures||1 year following the completion of radiation therapy|||||||
1227223|NCT00685763|Primary|Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)||1 year following the completion of radiation therapy||||participants|||Number
1227224|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||participants|||Number
1227225|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||participants|||Number
1227226|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|Number at Test of Cure Visit, ITT population|||participants|||Number
1227227|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|Number at the End of Treatment/Early Termination Visit, ITT population|||participants|||Number
1227228|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||participants|||Number
1227229|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||participants|||Number
1227230|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||participants|||Number
1227231|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||participants|||Number
1227232|NCT00685698|Secondary|Total Wound Score (at End of Treatment/ Early Termination in PP Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||scores on a scale||Standard Deviation|Mean
1227233|NCT00685698|Secondary|Total Wound Score (at End of Treatment/ Early Termination in ITT Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and End of Treatment/ Early Termination visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||scores on a scale||Standard Deviation|Mean
1227234|NCT00685698|Secondary|Total Wound Score (at Test of Cure in PP Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||scores on a scale||Standard Deviation|Mean
1227235|NCT00685698|Secondary|Total Wound Score (at Test of Cure in ITT Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||scores on a scale||Standard Deviation|Mean
1227236|NCT00685698|Secondary|Per-Pathogen Microbiological Responses|Microbiological responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Microbiological Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Microbiological Success rates for Streptococcus pyogenes in the PP population.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||percentage of participants||95% Confidence Interval|Number
1227237|NCT00685698|Secondary|Per-Pathogen Clinical Response (at End of Treatment/Early Termination)|Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at at End of Treatment/Early Termination within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||percentage of participants||95% Confidence Interval|Number
1227238|NCT00685698|Secondary|Per-Pathogen Clinical Responses (at Test of Cure)|Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||percentage of participants||95% Confidence Interval|Number
1227239|NCT00685698|Secondary|Clinical Success (at End of Treatment/Early Termination)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||percentage of participants||95% Confidence Interval|Number
1227240|NCT00685698|Secondary|Clinical Success (in PP Population)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1), and adhered to the protocol without major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1227241|NCT00685698|Secondary|Microbiological Success Rate|"Microbiological Success~Eradicated, defined as absence of the original pathogen(s) from a repeat culture of the original infection site performed at the TOC visit.~Presumed Eradicated, defined as meeting the definition for Clinical Success at the TOC visit, but tissue sample could be obtained for culture from the original infection site.~TOC=Test of Cure"|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||percentage of participants||95% Confidence Interval|Number
1227242|NCT00685698|Primary|Clinical Success (in ITT Population)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1).|||percentage of participants||95% Confidence Interval|Number
1227243|NCT00685685|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|54 subjects were enrolled and 51 subjects completed the study. Lovastatin plasma concentration data for 48 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 3 subjects. Mevacor® plasma concentration data for 50 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 1 subject.|||ng-hr/mL||Standard Deviation|Mean
1227244|NCT00685685|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
1227245|NCT00685685|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.|||ng/mL||Standard Deviation|Mean
1227246|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|24 months (approximately study days 547 - 730)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227247|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|18 months (approximately days 366 - 546)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227248|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|12 months (approximately study days 271 - 365)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227249|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|9 months (approximately study days 181 - 270)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227250|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|6 months (approximately study days 91 - 180)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227251|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|3 months (approximately study days 1 - 90)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227257|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|3 months (approximately study days 1 - 90)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
1227258|NCT00685659|Secondary|HIV Sex Risk Score|Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.|24 months|N's represent the participants at 24 months for whom we have a completed RAB (Risk Assessment Battery).|||units on a scale||Standard Deviation|Mean
1227259|NCT00685659|Secondary|HIV Sex Risk Score|Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.|12 months|N's represent the participants at 12 months for whom we have a completed RAB (Risk Assessment Battery).|||units on a scale||Standard Deviation|Mean
1227260|NCT00685659|Secondary|Participation in Protocol|Percent available sessions completed|24 months|Participants in TAU did not receive telephone counseling so were not included in these analyses. N's for TMAC and TMAC Plus represent participants who completed orientation.|||percentage of sessions||Standard Deviation|Mean
1227261|NCT00685659|Primary|Net Comparisons of Savings and Spendings Across Groups From Societal Perspective|Savings minus intervention costs. Presented in 2008 dollars.|24 months||||US Dollars||Standard Deviation|Mean
1227262|NCT00685659|Primary|Net Saving/Spending Comparisons Across Groups From Provider Perspective|Savings minus intervention costs. Presented in 2008 dollars.|24 months||||US Dollars||Standard Deviation|Mean
1227263|NCT00685659|Primary|Comparison Across Groups in Societal Costs|Total savings/spending calculated as the monetary value of days of illegal activity, days experiencing medical problems, days experiencing psychiatric problems, and days in jail captured with the ASI. Presented in 2008 dollars.|24 months||||US Dollars||Standard Deviation|Mean
1227264|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|24 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 24.|||proportion of participants positive|||Number
1227265|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|18 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 18.|||proportion of participants positive|||Number
1227266|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|12 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 12.|||proportion of participants positive|||Number
1227267|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|9 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 9.|||proportion of participants positive|||Number
1227268|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|6 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 6.|||proportion of participants positive|||Number
1227269|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|3 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 3.|||proportion of participants positive|||Number
1227270|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|24 month follow up|The N analyzed represents the number of participants we were able to reach for 24 month follow up.|||participants|||Number
1227271|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|18 month follow up|The N analyzed represents the number of participants we were able to reach for the 18 month follow up.|||participants|||Number
1227272|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|12 month follow up|The N analyzed represents the number of participants we were able to reach at the 12 month follow up for evaluation.|||participants|||Number
1227273|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|9 month follow up|The N analyzed represents the number of participants we were able to reach for the 9 month follow up evaluation.|||participants|||Number
1227295|NCT00685334|Primary|Tolerability|This study addressed the benefits, tolerability, acceptability, safety, and appropriate dosage of olanzapine and aripiprazole, as determined by clinical evaluation and self report. The outcome measure reported here is the number of patients who did not experience untoward side effects while taking the medication.|Measured at Week 12|Data was not available for all 22 participants.|||Participants|||Number
1227274|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|6 month follow up|The N analyzed represents that number of participants we reached for 6 month follow up evaluation.|||participants|||Number
1227275|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|3 month follow up|The N analyzed represents that number of people we reached for three month follow up evaluation.|||participants|||Number
1227276|NCT00685516|Secondary|Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).||6 weeks|Pre and post blood samples unavailable for: 4 participants in Arm I (GT group), 3 participants in Arm II (control/water group) and 3 participants in Arm III (BT group).|||ng/mL||Standard Deviation|Mean
1227277|NCT00685516|Secondary|Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).|Concentration of tea polyphenols and methyl-metabolites in urine after the consumption of GT and BT. No polyphenols were found after water consumption|6 weeks|"Urine concentration of (-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG)."|||umol/g creatinine||Standard Deviation|Mean
1227278|NCT00685516|Secondary|Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue|Examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.|6 weeks|"Concentration of tea polyphenols and methyl-metabolites in prostate tissue after the consumption of GT and BT. No polyphenols were found after water consumption.~(-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG)."|||(pmol/g tissue)||Standard Deviation|Mean
1227279|NCT00685516|Primary|Effect of Green Tea (GT) and Black Tea (BT) Consumption on Percentage of Cells With Positive Staining for Apoptosis, Proliferation, Oxidation, and Inflammation in Malignant Radical Prostatectomy Tissue Compared to Water Control Using Immunohistochemistry.|To determine the effect of Green Tea and Black Tea consumption on Prostate cancer tissue by examining programmed cell death, cell proliferation, cell oxidation, and cellular inflammation in that malignant radical prostatectomy tissue compared to water control using immunohistochemistry.|6 weeks|subjects that completed study|||percent positive of total cells||Standard Deviation|Mean
1227280|NCT00685477|Secondary|Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method||15, 30, 45 and 60 minutes post-infusion|Some participants were excluded from analyses due to location testing procedures|||percentage||Standard Deviation|Mean
1227281|NCT00685477|Primary|Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method|The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values.|15, 30, 45, and 60 minutes post drug infusion|Some participants were excluded from analyses due to location testing procedures|||percentage||95% Confidence Interval|Number
1227282|NCT00685399|Secondary|Number of Participants Who Were Able to Re-induce a Remission if a Flare-up Occurs|A flare was defined as an increase of inflammation in either eye so that the anterior chamber cell score or the vitreous haze score become 1+ or greater. Vitreous haze was evaluated with an indirect ophthalmoscope and a hand-held 20-diopter lens. Haze is defined as a reduction in the clarity of fundus details seen through the vitreous, the degree of haze was quantified using standard National Eye Institute (NEI) photographs. The standard photographs provide a grading scale with photographs of fundi with vitreous haze grades “0” (zero), “trace” (which counts as 0.5+), 1+, 2+, 3+, and 4+. If the amount of vitreous haze appears to fall between two integer grades, the value would be recorded as halfway between the grades. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Day 1 to Day 57|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||||||
1227283|NCT00685399|Secondary|Number of Participants With Remission in Uveitis|Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes after the first course of one or two doses by Day 57 visit . The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Baseline (Day 1) up to Month 8|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||||||
1227284|NCT00685399|Secondary|Number of Participants Who Were Able to Induce a Remission in Uveitis|Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes by Day 57 visit after the first course of one or two doses of AIN457 were to be categorized as nonresponders and were to be discontinued from the study at the Day 85 visit. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Day 1 to Day 85|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||||||
1227285|NCT00685399|Secondary|Number of Participants With Reduction in Oral Prednisone or Topical Corticosteroid and Other Immunosuppressant Drugs|Participants intake of oral prednisone or topical corticosteroid and other immunosuppressant drugs was reduced if participant was on up to 1.5 mg/kg/day dose of prednisone during the week prior to Day 1 or whom the resumption of prednisone was not considered the appropriate systemic therapy by investigator or who have never been on systemic immunosuppressive therapy and whose uveitis was so severe that, in the clinician’s judgment, prednisone at a dose of 1.0-1.5 mg/kg/day alone will be insufficient to control the uveitis or participant with HLA-B27-associated anterior uveitis who would ordinarily be started on systemic prednisone. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Baseline (Day 1) up to Month 8|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||||||
1227286|NCT00685399|Secondary|Number of Complete Responders in Cohort 2, 3 and 6 at Day 57|A “complete responder” was defined as a participant who was able to stop all topical and systemic corticosteroids in both eyes and maintain remission of uveitis (=remains a responder as defined above) lasting at least 1 week (since stopping corticosteroids, if corticosteroids were given).|Day 1 (Baseline), Day 57|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.|||Participants|||Number
1227287|NCT00685399|Secondary|Number of Responders in Cohort 1, 2, 3 and 6 at Day 57|A “responder” was defined as a participant who fulfilled at least one of the 3 criteria compared to baseline: 1. Increase in visual acuity by at least 15 letters using Early Treatment Diabetic Retinopathy Study method, no increase in daily prednisone dose compared to week 1 and without worsening of uveitis. 2. Decrease in vitreous haze by 2 steps or more or for participants with anterior uveitis, resolution of the anterior chamber inflammation (i.e., no cells or only a rare cell in the anterior chamber (score 0 or trace (0.5+)), use measurement before dilation), no increase in daily prednisone dose compared to week 1 and without any worsening of uveitis.3 For those participant on a. >20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 10 mg/day or less. b. ≤20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 0 mg/day. c. topical corticosteroids during week 1: Reduction in daily topical corticosteroid dose to 0 during the last 2 weeks.|Day 1 (Baseline), Day 57|The Per Protocol Analysis Set (PPAS) consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.|||Participants|||Number
1227288|NCT00685399|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Day 603|Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug and had at least one post–baseline safety assessment. All safety evaluations were carried out on the safety analysis set.|||participants|||Number
1227289|NCT00685373|Secondary|Pharmacokinetics|Mean Clearance from serum in Liter per Day (CLD) in adult participants >=18, pediatric participants <18 with body weight >40 kg and pediatric participants <18 with body weight <=40 kg.|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety population defined as all participants who received at least 1 dose of study drug. 3 participants were excluded because dosing information was not available at the time of analysis.|||L/day||Standard Deviation|Mean
1227290|NCT00685373|Secondary|Immunogenicity of Canakinumab (ACZ885)|The number of participants who tested positive for anti-ACZ885 antibodies using the Biacore Assay at the end of the study.|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety Population defined as all participants who received at least one dose of study drug and were tested for anti-ACZ885 antibodies at the end of the study.|||participants|||Number
1227291|NCT00685373|Secondary|The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers.|"Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal.~Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe."|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety Population defined as all participants who had at least one dose of study drug and were included in the Relapse Assessment.|||Percentage of participants|||Number
1227292|NCT00685373|Primary|The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions|The number of participants with Adverse Events and Infections & Infestations are regardless of study drug relationship by primary system organ class preferred term equal and/or greater than 2% in any group. The number of participants with mild injection site reactions= mild reactions observed on at least one occasion but no moderate or severe reactions. The number of participants with moderate injection site reactions= moderate reactions observed on at least one occasion but no severe reactions.|2 years depending on when the participant enters the study|Safety Population defined as all participants who received at least one dose of study drug.|||participants|||Number
1227293|NCT00685334|Secondary|Treatment Compliance|Total number of randomized patients that completed the full 12 weeks of treatment.|Measured at Week 12|||||||
1227300|NCT00685178|Secondary|Voucher Earnings|"Voucher earnings used as a measurement of contigency management (CM) or operate conditioning. Volunteers were rewarded vouchers of escalating monetary value for cocaine abstinence, as indicated by a cocaine negative urine sample. The first cocaine negative urine earned a $2.50 voucher, and the value increased by $1.50 for each subsequent cocaine negative sample. Volunteers were awarded a bonus of $10.00 for every three consecutive cocaine negative urine samples. Urine samples were collected 3 times per week, and vouchers were attainable between Weeks 8 and 20.~Contingency management as a measurement of operant conditioning in which positive reinforcement is applied (in this case vouchers of monetary value) and cocaine abstinence"|12 weeks (Weeks 8-20)||||Dollars||Standard Error|Mean
1227301|NCT00685178|Primary|Proportion of Cocaine Positive Urine Samples Per Treatment Condition|Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)|Urine samples collected 3 times weekly from week 1 through 26|This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.|||percentage of positive urine samples|||Number
1227302|NCT00685165|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.|||ng-hr/mL||Standard Deviation|Mean
1227303|NCT00685165|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.|||ng-hr/mL||Standard Deviation|Mean
1227304|NCT00685165|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.|||ng/mL||Standard Deviation|Mean
1227305|NCT00685139|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
1227306|NCT00685139|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 33 out of 34 subjects who completed this study. One subject elected to withdraw prior to the study hour 2 blood sample collection during period II.|||ng/mL||Standard Deviation|Mean
1227307|NCT00685035|Secondary|Patients' Perceived Comfort Using the Different Settings for the Vest Device|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable). Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."|Immediately following each airway clearance therapy on day 1 and day 4|power calculation not performed for secondary outcomes|||units on a scale||Full Range|Median
1227308|NCT00685035|Secondary|Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."|Sputum produced during the 15 minutes immediately following airway clearance therapy sessions on day 1 and day 4|power calculation not performed for secondary outcomes|||dynes/cm^2||Full Range|Median
1227309|NCT00685035|Secondary|Pre vs. Post Therapy Spirometry|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.|Prior to and following each airway clearance therapy session on days 1 and 4|Power calculation not performed for secondary outcomes.|||ml||Standard Deviation|Mean
1227342|NCT00684762|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.|||ng/mL||Standard Deviation|Mean
1227310|NCT00685035|Primary|Sputum Wet and Dry Weight|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container."|Produced during each airway clearance therapy session on days 1 and 4|In a previous study with similar design,21 the standard deviation for the difference in the mean sputum wet weight between treatment arms was 4.6 g. Assuming the same standard deviation for the current study, enrollment of 16 subjects provided an 80% chance of detecting a 3.5-g difference in the sputum wet weights at a significance level of .05.|||grams||Full Range|Median
1227311|NCT00684996|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1227312|NCT00684996|Primary|Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST), Including Confirmed and Unconfirmed Complete and Partial Responses (Phase II)|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of nonmeasurable disease. No new lesions.|Up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
1227313|NCT00684996|Primary|Overall Survival (Phase II)|Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|From date of registration to date of death due to any cause, assessed up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
1227314|NCT00684996|Primary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 (Phase II)|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
1227315|NCT00684996|Primary|Progression-free Survival (Phase II)|Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|From date of registration to date of first observation of progressive disease, systemic deterioration, or death due to any cause, assessed up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
1227316|NCT00684996|Primary|Maximum Tolerated Dose of Bevacizumab , Based on Incidence of Dose-limiting Toxicity (DLT) Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)||Up to 8 weeks|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
1227317|NCT00684983|Secondary|Adverse Event Profile of Capecitabine and Lapatinib With and Without IMC-A12 (Using NCI CTCAE v3.0)|"All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) according to CTCAE v3.0 within each treatment arm. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.~4/19 (21.05%) 14/45 (31.11%)"|Baseline to 30 days past end of treatment||||percentage of patients with AEs|||Number
1227318|NCT00684983|Secondary|Duration of Response|Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.|Up to 5 years|Evaluable patients that had a response to treatment drug|||Months||Full Range|Median
1227319|NCT00684983|Secondary|Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)||Up to 5 years|Includes patients with at least one disease assessment at least 6 weeks after registration.|||% of evaluable participants||95% Confidence Interval|Number
1227320|NCT00684983|Secondary|Time to Treatment Failure|Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.|From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 years||||Months||Full Range|Median
1227321|NCT00684983|Secondary|Overall Survival|Median Survival time (months)|From randomization to death due to any cause, up to 5 years|All evaluable patients|||Months||Full Range|Median
1227322|NCT00684983|Primary|Progression-free Survival (PFS)|Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.|From randomization to the earliest date of documentation of disease progression, up to 5 years|First 8 patients in Arm B are from safety cohort, they are not eligible for primary end point|||Median survival and CI in months||95% Confidence Interval|Median
1227343|NCT00684749|Secondary|Surgeon Satisfaction With Outcome|Patient completedsurvey regarding outcome|1 Year|||||||
1227344|NCT00684749|Secondary|Patient Satisfaction With Outcome|Patient completed a survey regarding outcome|1 Year|||||||
1227345|NCT00684749|Primary|Reoperation Rates|Surgeon completed survey|2 years|All patients who were treated in the time period|||participants|||Number
1227323|NCT00684814|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate|The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.|||ng-hr/mL||Standard Deviation|Mean
1227324|NCT00684814|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.|||ng-hr/mL||Standard Deviation|Mean
1227325|NCT00684814|Primary|Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate|The maximum or peak concentration that zolpidem tartrate reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.|||ng/mL||Standard Deviation|Mean
1227326|NCT00684788|Secondary|HIV Risk Behaviors|Went to a crack house|4 months||||percentage of months reported||Standard Deviation|Mean
1227327|NCT00684788|Secondary|Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine|Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100|18 weeks|intent to treat|||percentage of cocaine negative||Full Range|Mean
1227328|NCT00684788|Secondary|Percentage of 30-day Assessments Urine Samples Negative for Cocaine|(The number of urine samples that were negative for cocaine/total number of urine samples)x 100|4 months||||percentage of cocaine negative||Full Range|Mean
1227329|NCT00684788|Secondary|Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates|Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100|18 weeks||||percentage of opiate negative||Full Range|Mean
1227330|NCT00684788|Secondary|Percentage of 30-day Assessments Urine Samples Negative for Opiates|(The number of urine samples that were negative for opiates/total number of urine samples)x 100|4 months||||percentage of opiate negative||Full Range|Mean
1227331|NCT00684788|Secondary|The Time to the First Missed Dose of Depot Naltrexone|The number of weeks until the first missed dose of depot naltrexone|18 weeks||||weeks||Standard Deviation|Mean
1227332|NCT00684788|Primary|Percentage of Depot Naltrexone Doses Received|The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.|18 Weeks||||percentage of injections||Full Range|Mean
1227333|NCT00684775|Secondary|Percentage of M,W,F Urine Samples Negative for Opiates|Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates|Collected every Monday, Wednesday and Friday for 24 weeks|intent to treatment|||percentage of opiate negative||Full Range|Mean
1227334|NCT00684775|Secondary|HIV Risk Behaviors|behaviors that place participants at risk for acquiring or transmitting HIV infection|24 weeks||||percentage of months reported||Standard Deviation|Mean
1227335|NCT00684775|Secondary|Average Percentage of 30-day Urine Samples Negative for Cocaine|The percentage of urine samples collected at 30-day assessments that are negative for cocaine.|Collected every 30 days for 150 days|intent to treat|||percentage cocaine negative urine sample||Full Range|Mean
1227336|NCT00684775|Secondary|Percentage of M-W-F Samples Negative for Cocaine|Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine|Collected every Monday, Wednesday and Friday for 24 weeks|intent to treat|||percentage of mwf cocaine negative||Full Range|Mean
1227337|NCT00684775|Secondary|Percentage of 30-day Urine Samples Negative for Opiates|Percentage of urine samples collected at the 30-day assessments that are negative for opiates|Collected every 30 days for 150 days|intent to treat|||percentage of opiate negative||Full Range|Mean
1227338|NCT00684775|Primary|Time to the First Missed Dose|The time to the first missed dose of depot naltrexone|24 weeks||||weeks||Standard Deviation|Mean
1227339|NCT00684775|Primary|Naltrexone Injections Received|The percentage of depot naltrexone doses that participants received|24 weeks|intent-to-treat|||Percentage of injections received||Full Range|Mean
1227340|NCT00684762|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable cilostazol (reference and test) plasma concentration to the elimination rate constant.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 26 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used. Additionally, two subjects had data values that were not used in this analysis.|||ng-hr/mL||Standard Deviation|Mean
1227341|NCT00684762|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable cilostazol (test and reference) concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.|||ng-hr/mL||Standard Deviation|Mean
1227547|NCT00683774|Primary|Renal Clearance of D-chiroinositol (DCI) at 12 Days|Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay|12 days||||ml/min||Full Range|Mean
1227346|NCT00684723|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
1227347|NCT00684723|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
1227348|NCT00684723|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.||||ng/mL||Standard Deviation|Mean
1227349|NCT00684671|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.|During one month following the administration of the challenge dose||||Participants|||Count of Participants
1227350|NCT00684671|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.|Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year)||||Participants|||Count of Participants
1227351|NCT00684671|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptoms = any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 31-day follow-up period after the challenge dose.||||Participants|||Count of Participants
1227352|NCT00684671|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius).|During the 4-day follow-up period after the challenge dose.||||Participants|||Count of Participants
1227353|NCT00684671|Secondary|Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.|Two weeks and one month after the challenge dose|Analysis was performed on the Log-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
1227354|NCT00684671|Secondary|Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.|Prior to administration of challenge dose|Analysis was performed on the Long-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
1227355|NCT00684671|Primary|Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|"Anamnestic response was defined as :~for initially seronegative subjects, antibody concentration ≥ 10 Milli-International Units per Milliliter (mIU/mL),~for initially seropositive subjects: antibody concentration at ≥ 4 fold the pre-vaccination antibody concentration."|One month after the challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||Participants|||Count of Participants
1227356|NCT00684671|Primary|Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies|"Anamnestic response was defined as:~for initially seronegative subjects, antibody concentration greater than or equal the cut-off [≥ 15 Milli-International Units per Milliliter (mIU/mL)],~for initially seropositive subjects with pre-vaccination antibody, concentration < 100 mIU/mL: antibody concentration at least four times the pre-vaccination antibody concentration,~for initially seropositive subjects with pre-vaccination antibody concentration ≥ 100 mIU/mL: antibody concentration at least two times the pre-vaccination antibody concentration."|One month after the challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||Participants|||Count of Participants
1227357|NCT00684645|Other Pre-specified|Percentage of Participants Responding to Treatment|Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started.|12 months|All participants|||percentage of participants|||Number
1227358|NCT00684645|Other Pre-specified|Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade|Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (>) 20% during the study. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20 millimeters of Mercury (mm Hg) (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (>=24 hours) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL; Grade 3: Requiring >1 drug or more intensive therapy than previously; Grade 4: Life-threatening; Grade 5: Death.|Baseline up to 12 months|All participants|||percentage of participants|||Number
1227359|NCT00684645|Other Pre-specified|Summary of Adverse Events for Participants Who Required Dose Modification|Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment.|Baseline up to 12 months|Number of participants analyzed = All participants who required dose modification because of an adverse event. The total number of participants may exceed the number of participants analyzed because one participant may have reported more than one adverse event.|||participants|||Number
1227360|NCT00684645|Primary|Percentage of Participants With Hypertension|Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20mm Hg (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL. Grade 3: Requiring >1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death.|Baseline, Week 6, Months 3, 6, 9, 12|FAS. n = number of participants with evaluable data at that time point.|||percentage of participants|||Number
1227361|NCT00684645|Primary|Percentage of Participants With Hypothyroidism|TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level >5.0 mIU/L at that time point.|Baseline, Months 3, 6, 9, 12|FAS. n = number of participants with evaluable data at that time point.|||percentage of participants|||Number
1227362|NCT00684645|Primary|Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)|Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS.|Baseline to date of death (up to 12 months)|FAS|||participants|||Number
1227363|NCT00684645|Primary|Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)|Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension).|Baseline to date of first documentation of response to treatment (up to 12 months)|FAS|||participants|||Number
1227364|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 12|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
1227365|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 9|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
1227366|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 6|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
1227367|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 3|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
1227368|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Week 6|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
1227369|NCT00684645|Primary|Overall Survival (OS)|OS is the duration from enrollment to death.|Baseline to date of death (up to 12 months)|FAS|||months||95% Confidence Interval|Median
1227370|NCT00684645|Primary|Progression-free Survival (PFS)|The period from study entry until disease progression, death, or date of last contact.|Baseline to measured progressive disease (up to 12 months)|FAS|||months||95% Confidence Interval|Median
1227371|NCT00684645|Primary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|12 months|Full analysis set (FAS): all participants who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Number
1227372|NCT00684593|Secondary|Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all participants for which serum samples were available for the determination of Tmax at Day 28.|||Hours||Full Range|Median
1227373|NCT00684593|Secondary|Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all enrolled participants for which serum samples were evaluable for T1/2. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing. An additional 2 participants were excluded from the population because their T1/2 was incalculable.|||Hours||Standard Deviation|Mean
1227374|NCT00684593|Secondary|Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all enrolled participants for which serum samples were evaluable at Day 28 for AUC (0-24). One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.|||hr*ng/mL||Standard Deviation|Mean
1227375|NCT00684593|Secondary|Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all participants for which serum samples were available for the determination of Cmax at Day 28. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.|||ng/mL||Standard Deviation|Mean
1227376|NCT00684593|Secondary|Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29|The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.|Day 29|The population consisted of all treated participants with follow-up.|||Participants|||Number
1227377|NCT00684593|Primary|Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29|PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).|Baseline and Day 29|The population consisted of all treated participants with follow-up.|||Score on a Scale||Standard Deviation|Mean
1227378|NCT00684567|Secondary|Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response|"CR = measurable lesion disappeared.~PR = total sum of lesions measurable in bidimension decreased by 50% or more on whole and no secondary progression attributable to tumor was noted. No onset of new lesion."|1 year after the start of administration in the concomitant radiotherapy phase|Response rate in terms of tumor response (ratio of CR + PR) in 19 participants was assessed by Efficacy and Safety Evaluation Committee. 19 participants were found to have measurable lesions. Nineteen participants (as opposed to 30 participants) were analyzed because that is how many participants were still alive 1 year after start of therapy.|||Participants|||Number
1227379|NCT00684567|Secondary|Number of Participants With Progression Free Survival (PFS) for 1 Year|Administration of SCH 52365 was continued until progression was observed (progression was judged by the investigator based on MRI and clinical symptoms).|1 year after the start of admininstration in the concomitant radiotherapy phase||||Participants|||Number
1227380|NCT00684567|Primary|Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.|until 30 days after the completion of administration of monotherapy||||Participants|||Number
1227381|NCT00684567|Primary|Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.|until 30 days after the completion of administration of monotherapy||||Participants|||Number
1227382|NCT00684567|Primary|Adverse Events With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.|until 30 days after the completion of administration of monotherapy||||Participants|||Number
1227383|NCT00684554|Secondary|Prolonged Withdrawal|participants experiencing prolonged withdrawal beyond two days after buprenorphine induction|a) 2 days|participants who initiated induction|||participants|||Number
1227384|NCT00684554|Primary|The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.|The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.|one week after initial primary care visit|patients who in initiated induction|||participants|||Number
1227548|NCT00683696|Secondary|Number of Subjects With All-cause Mortality|Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.|From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years||||Participants|||Count of Participants
1227385|NCT00684541|Secondary|Social Phobia and Agoraphobia Inventory|Our secondary outcome assessment of social anxiety symptoms was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), a 45-item self-rated measure that assesses the cognitive, behavioral, and somatic dimensions of SAD. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. Previous research suggests that the SPAI has sound psychometric properties (e.g., Turner et al., 1989). Internal consistencies for these measures in the current sample were satisfactory.|Pre, Post (6 weeks), Followup (3 months after post-assessment)||||units on a scale||Standard Deviation|Mean
1227386|NCT00684541|Primary|Liebowitz Social Anxiety Scale (LSAS)|Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms.|Pre, Post (6 weeks), Followup (3 months after post-assessment)||||units on a scale||Standard Deviation|Mean
1227387|NCT00684515|Secondary|Mean Membrane-Bound P-Selectin Levels By Study Visit|Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had membrane-bound p-selectin data available.|||Arbitrary Units||Standard Error|Mean
1227388|NCT00684515|Secondary|Mean CD40 Ligand Levels By Study Visit|Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had CD40 ligand data available.|||mg/L||Standard Error|Mean
1227389|NCT00684515|Secondary|Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit|Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden.|Up to Day 60|The population consisted of all enrolled participants who received at least one dose of study drug and had hs-CRP data available.|||mg/L||Standard Deviation|Median
1227390|NCT00684515|Secondary|Number of Participants With MACE or Death|The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization.|Up to Day 121|The population consisted of all enrolled participants that received at least one dose of study drug.|||Participants|||Number
1227391|NCT00684515|Secondary|Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events|Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages <10 mm evident on magnetic resonance imaging [MRI]), clinical over signs of hemorrhge associated with a drop in hemoglobin >=5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in a hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had TIMI bleeding data available.|||Participants|||Number
1227392|NCT00684515|Primary|Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis.|Up to Day 121|The population consisted of all enrolled participants that received at least one dose of study drug.|||Participants|||Number
1227393|NCT00684424|Secondary|Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale|MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.|Baseline, Week 16 (Final Visit)|FAS. Abbreviations: BL = Baseline; FV = Final Visit.|||participants|||Number
1227394|NCT00684424|Secondary|Medical Outcomes Sleep Scale (MOS-S)|MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 16 (Final Visit )|FAS. A subscale was classified as missing if any of the questions used in the calculation were missing. Abbreviations: BL = Baseline, SOB = short of breath.|||scores on scales||Standard Deviation|Mean
1227395|NCT00684424|Secondary|Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)|CGI-C scale: physician’s global impression of a subject’s clinical condition in terms of change from baseline. Improvement = CGI response of very much improved, much improved, or minimally improved. No Change = CGI response of no change. Worsening = CGI response of very much worse, much worse or minimally worse.|Week 16 (Final Visit)|FAS|||participants|||Number
1227396|NCT00684424|Secondary|Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S scale: physician’s global impression of a subject’s clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.|Baseline|FAS|||participants|||Number
1227397|NCT00684424|Secondary|Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)|Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.|Baseline, Week 16 (Final Visit), Last Observation Carried Forward|FAS; Last observation carried forward (LOCF) method: subject’s last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.|||mm||Standard Deviation|Mean
1227398|NCT00684424|Secondary|Visual Analog Scale of Anxiety (VAS-A)|Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.|Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward|FAS; Last observation carried forward (LOCF) method: subject’s last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.|||mm||Standard Deviation|Mean
1227399|NCT00684424|Secondary|Average Dosage of Pregabalin Taken at Baseline and Final Visit|Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.|Baseline, Week 16 (Final Visit )|Safety analysis set.|||participants|||Number
1227400|NCT00684424|Secondary|Concomitant Drug Treatments|Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.|Baseline through Week 16 (Final Visit)|Safety analysis set.|||participants|||Number
1227401|NCT00684424|Secondary|Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study|Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.|Week 8 up to Week 16 (Last 4 weeks of the treatment period)|FAS|||participants|||Number
1227402|NCT00684424|Secondary|Change in 28 Day Partial Seizure Frequency|Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.|Baseline through Week 16 (Final Visit )|FAS. Subjects who discontinued less than 4 weeks into the treatment period or with missing date of the attack were excluded from analyses.|||number of seizures per 28 days||Standard Deviation|Mean
1227403|NCT00684424|Secondary|Antiepileptic Drugs Used in the Past|Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.|Baseline|Safety analysis set: all subjects who received at least 1 dose of study medication.|||participants|||Number
1227404|NCT00684424|Primary|Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency|Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.|Baseline through Week 16|Full Analysis Set: all subjects who received at least 1 dose of study drug and had at least 1 efficacy measurement.|||participants|||Number
1227405|NCT00684411|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival for the earlier of 6 weeks from the end of treatment or death. Maximum follow-up was 288 days in this study cohort.|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.|||days||90% Confidence Interval|Median
1227406|NCT00684411|Secondary|Progression-Free Survival|"Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Disease progression was assessed per International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].~Per International Working Group response criteria in lymphoma progressive disease (PD) was defined as the appearance of new lesions; the sum of the product of the diameter (SPD) increasing ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall; or, in any single nodal target lesion, a node with a short axis > 10 mm must increase > 50% in greatest transverse diameter or a node with short axis <10mm must increase by at least 50% to at least 15 mm x 15 mm or have a greatest transverse diameter greater than 15 mm."|Disease was evaluated radiologically at baseline, on treatment at weeks 8, 16, 24 and every 12 weeks thereafter, off treatment for 6 weeks or until death, whichever occurs first. Treatment duration was a median of 56 days (range 5-253 days).|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.|||days||90% Confidence Interval|Median
1227427|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events|Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had bleeding event data available.|||Participants|||Number
1227428|NCT00684203|Secondary|Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI|Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had CD40 ligand data available.|||ng/mL||Standard Error|Mean
1227407|NCT00684411|Primary|Overall Response Rate|"Overall response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].~Per the International Working Group response criteria in lymphoma (Cheson 2007) for target lesions assessed by CT: Complete response (CR): nodes that were greater than 15 mm in greatest transverse diameter at baseline shrank to less than 15 mm in greatest transverse diameter and those that were 11-15 mm in greatest transverse diameter but had a short axis diameter greater than 10 mm had a short axis diameter less than 10mm and a transverse diameter that remained less than 15 mm; partial response (PR) was defined as a decrease in the sum of the product of the diameter of target lesions by more than 50% but not fulfilling criteria for CR. Overall response was defined as CR+PR."|Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days).|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.|||proportion of participants||90% Confidence Interval|Number
1227408|NCT00684320|Secondary|Social Phobia and Anxiety Inventory|Our primary self-report outcome measure was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), which consists of 45 items assessing the cognitive, behavioral, and somatic dimensions of SP. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. This measure has strong psychometric properties (Turner et al., 1989) and has been widely used in previous treatment outcome research in SP (e.g., Clark et al., 2006).|Pre-Treatment, Post-Treatment (after 4 weeks of treatment)||||units on a scale||Standard Deviation|Mean
1227409|NCT00684320|Primary|Liebowitz Social Anxiety Scale (LSAS)|Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms|Pre-Treatment, Post-Treatment (6 weeks)||||units on a scale||Standard Deviation|Mean
1227410|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC|Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T|36 weeks according to protocol||||L/h||Full Range|Median
1227411|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC|Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T|36 weeks according to protocol||||L/h||Full Range|Median
1227412|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT|Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T|36 weeks according to protocol||||L/h||Full Range|Median
1227413|NCT00684307|Secondary|Plasma Concentration of AR-H067637XX (Active Metabolite)|Assessment made on the week 12 visit|12 weeks after baseline according to protocol||||nmol/L||Full Range|Median
1227414|NCT00684307|Secondary|Plasma Concentration of AZD0837 (Prodrug)|Assessment made on the week 12 visit|12 weeks after baseline according to protocol||||nmol/L||Full Range|Median
1227415|NCT00684307|Secondary|Ecarin Clotting Time (ECT)|Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)||||sec||Full Range|Median
1227416|NCT00684307|Secondary|Activated Partial Thromboplastin Time (APTT)|Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)||||sec||Full Range|Median
1227417|NCT00684307|Secondary|D-Dimer|Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)|14 weeks according to protocol.(enrolment to week 12 visit)||||ng/mL||Full Range|Median
1227418|NCT00684307|Primary|Bilirubin|Number of patients while on study drug with Bilirubin>=2 times upper limit of normal|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)||||Participants|||Number
1227419|NCT00684307|Primary|Alanine Aminotransferase (ALAT)|Number of patients while on study drug with ALAT>=3 times upper limit of normal.l|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)||||Participants|||Number
1227420|NCT00684307|Primary|Creatinine|Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)||||umol/L||Standard Deviation|Mean
1227421|NCT00684307|Primary|Bleeding Events|Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)||||Participants|||Number
1227422|NCT00684255|Secondary|Progression Free and Overall Survival.|Probability of progression free and overall survival will be measured.|1 year|||||||
1227423|NCT00684255|Secondary|Immune Reconstitution.|Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell.|1 year|||||||
1227424|NCT00684255|Secondary|Chimerism|Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points.|1 year|||||||
1227425|NCT00684255|Primary|Toxicity|Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured.|1 year|||||||
1227426|NCT00684242|Primary|Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS)|"Changes in cancer pain from baseline to day 15 using ESAS to measure participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Intensity of symptoms rated on a 0 to 10 scale from 0 no symptom to 10 worst possible symptom."|From baseline to Day 15|One participant was not evaluable for Day 15.|||units on a scale|||Number
1227429|NCT00684203|Secondary|Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI|Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hs-CRP data available.|||mg/L||Standard Deviation|Median
1227430|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization|Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group.|Up to Day 30|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hospitalization data available.|||Participants|||Number
1227431|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion|Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group.|Up to Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had transfusion data available.|||Participants|||Number
1227432|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events|Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI.|Up to 10 Hours Post-CABG|Evaluation of the bleeding events associated with CABG occurring after Vorapaxar treatment was not analyzed since only three participants in the non-PCI cohort underwent CABG in this study.||||||
1227433|NCT00684203|Secondary|Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group.|Up to Day 121|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had non-MACE AE data available.|||Participants|||Number
1227434|NCT00684203|Secondary|Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI|Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group.|Up to Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had TIMI bleeding data available.|||Participants|||Number
1227435|NCT00684203|Secondary|Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge|Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group.|Up to Day 121|The population included all participants who received at least 1 dose of study drug, underwent PCI, and had bleeding event data.|||Participants|||Number
1227436|NCT00684203|Secondary|Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI|Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants that received at least 1 dose of study drug and underwent PCI with membrane-bound P-selectin data available.|||Arbitrary Units||Standard Error|Mean
1227437|NCT00684203|Secondary|Mean CD40 Ligand Levels Among Participants Who Underwent PCI|Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with CD40 ligand data available.|||ng/mL||Standard Error|Mean
1227438|NCT00684203|Secondary|Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit|Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with hs-CRP data available.|||mg/L||Inter-Quartile Range|Median
1227439|NCT00684203|Secondary|Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit|Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60, Day 74, Day 90, Day 121|The population consisted of all enrolled participants who received at least 1 dose of study drug and underwent PCI with inhibition of platelet aggregation data available.|||Participants|||Number
1227449|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
1227440|NCT00684203|Secondary|Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI|Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo magnetic resonance imaging [MRI]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group.|Up to Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with TIMI bleeding data available.|||Participants|||Number
1227441|NCT00684203|Secondary|Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group.|Up to Day 121|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with Non-Major MACE data available.|||Participants|||Number
1227442|NCT00684203|Primary|Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI.|||Participants|||Number
1227443|NCT00684177|Secondary|Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)|"Therapeutic Success (Succ) was referred to as both Clinical Succ and Microbiological (Micro) Succ at Follow-up. Clinical Succ was the Resolution of baseline signs/symptoms of infection with a pus score of 0. A participant was Micro Succ if the micro outcome for all baseline pathogens (bps) belonged to Eradication (elimination of bps), Presumed Eradication (clinical outcome is success; no culturable material), or Colonization (new pathogen is identified at end of therapy in participants who are resolved/improved). All other combinations were deemed Therapeutic Failures."|Follow-up (Days 12-14)|ITTB subset of Primary Efficacy Population|||participants|||Number
1227444|NCT00684177|Secondary|Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)|"The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The results presented below pooled all baseline pathogens (bps). Eradication: elimination of bps. Presumed Eradication: clinical outcome was success; no culture was obtained due to lack of culturable material. Presumed Improvement: clinical outcome was improvement such that no culture was obtained due to lack of culturable material. Persistence: bps still present. Presumed persistence: clinical failure and no culture was obtained."|Days 7-9|ITTB subset of Primary Efficacy Population|||baseline pathogens|||Number
1227445|NCT00684177|Secondary|Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)|Clinical outcome is determined by the investigator based on signs and symptoms (S/S) at the end of therapy evaluation. The 4 clincal outcome categories are: clinical success, resolution of clinically meaningful S/S of infection recorded at baseline (BL), including a pus/exudates score of 0; clinical improvement, improvement of S/S of infection recorded at BL to such an extent that no further antimicrobial therapy is necessary; clinical failure, insufficient improvement of deterioration of S/S of infection recorded at BL such that additional antibiotic therapy is required; unable to determine.|Days 7-9|Primary Efficacy Population|||participants|||Number
1227446|NCT00684177|Secondary|Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)|"The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The by subject microbiological response was Microbiological Success if the microbiological outcomes for all baseline pathogens (bps) belong to Eradication (elimination of bps), Presumed Eradication (clinical outcome was success; no culture was obtained due to lack of culturable material), or Colonization (previously unidentified pathogen is identified at end of therapy in participant who is resolved/improved); otherwise, response was Microbiological Failure."|Days 12-14|ITTB subset of Primary Efficacy Population|||participants|||Number
1227447|NCT00684177|Secondary|Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population|"“Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items."|Days 12-14|ITTB subset of Primary Efficacy Population: participants in the Primary Efficacy Population (see analysis population description in the Primary Outcome section) who had at least one pathogen isolated at the baseline visit.|||participants|||Number
1227448|NCT00684177|Primary|Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population|"“Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items."|Days 12-14|Primary Efficacy Population: ITTC participants (par.) with baseline pus/exudate >=3 who were enrolled under the original protocol with data captured under eCRF V1 and who were enrolled under protocol amendments with data captured under eCRF V2; ITTC (Intent-to-treat Clinical): all randomized par. who received at least one dose of study medication.|||participants|||Number
1227450|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
1227451|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
1227452|NCT00684138|Secondary|Binocular Distance Corrected Distance Visual Acuity|Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
1227453|NCT00684138|Primary|Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)|Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.|3 months|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
1227454|NCT00684073|Primary|Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).|"Score of 0 = Not satisfied at all; Score of 10 = Totally satisfied"|Each treatment Day (post-dose on days 1-5)|Intent to Treat (ITT) - each day's results were based on number of subjects who had a Day 1 visit.|||centimeters||Standard Deviation|Mean
1227455|NCT00684060|Primary|Regional Left Ventricular Function (Border Zone Wall Motion)|Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|Measured at Baseline and Month 6|"Five patients were excluded from analysis due to incomplete signal intensity enhancement data (1) or lack of a signal intensity enhancement signal in the border zone (4).~Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months."|||mm||Standard Deviation|Mean
1227456|NCT00684060|Primary|Regional Left Ventricular Function (Infarct Zone Wall Motion)|One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included. One patient was excluded from the analysis due to incomplete signal intensity enhancement data.~Values reported represent the change in wall motion over time in the infarct zone from baseline to six months."|||mm||Standard Deviation|Mean
1227457|NCT00684060|Secondary|Infarct Volume|Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in infarct volume from baseline to six months."|||mL||Standard Deviation|Mean
1227458|NCT00684060|Secondary|End Systolic Volume Index|Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end systolic volume index from baseline to six months."|||mL/m2||Standard Deviation|Mean
1227459|NCT00684060|Secondary|End Diastolic Volume Index|Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end diastolic index from baseline to six months."|||mL/m2||Standard Deviation|Mean
1227460|NCT00684060|Secondary|Left Ventricular Mass|Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.)|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV mass from baseline to six months."|||g||Standard Deviation|Mean
1227461|NCT00684060|Secondary|Combined Endpoint|Combined endpoint: first of death, reinfarction, repeat revascularization, and hospitalization for heart failure. This is measured as the number of events by treatment group over the 6 month follow up period.|Measured at Baseline and Month 6|All randomized patients were followed for clinical outcomes. However the paucity of events precluded a reliable time to event analysis.|||events|||Number
1227462|NCT00684060|Primary|Global Left Ventricular Function|Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in Global EF from baseline to six months."|||percentage of ejection fraction||Standard Deviation|Mean
1227463|NCT00684047|Secondary|Prevalence of Treatment Failures|The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II)|10 minutes from the start of treatment application at the target bleeding site|intent to treat population|||percentage of participants|||Number
1227464|NCT00684047|Secondary|Proportions of Subjects Achieving Hemostasis|The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II)|10 minutes from the start of treatment application at the target bleeding site|intent to treat population|||percentage of participants|||Number
1227465|NCT00684047|Primary|The Primary Efficacy Endpoint is Time to Hemostasis.|The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.|The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.||||percentage of subjects|||Number
1227466|NCT00684021|Primary|Regional Left Ventricular Function (Border Zone Wall Motion)|Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|Measured at Baseline and Month 6|Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|||mm||Standard Deviation|Mean
1227467|NCT00684021|Primary|Regional Left Ventricular Function (Infarct Zone Wall Motion)|One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|Measured at Baseline and Month 6|Only participants with both baseline and 6 month MRI images available are included. Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|||mm||Standard Deviation|Mean
1227468|NCT00684021|Secondary|Infarct Volume|Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in infarct volume from baseline to six months."|||mL||Standard Deviation|Mean
1227469|NCT00684021|Secondary|End Systolic Volume Index|Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end systolic volume index from baseline to six months."|||mL/m2||Standard Deviation|Mean
1227470|NCT00684021|Secondary|End Diastolic Volume Index|Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end diastolic index from baseline to six months."|||mL/m2||Standard Deviation|Mean
1227471|NCT00684021|Secondary|Left Ventricular Mass|Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV mass from baseline to six months."|||g||Standard Deviation|Mean
1227472|NCT00684021|Secondary|Clincal and Safety Outcomes|Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements|Measured from baseline to six months.|All randomized patients were followed for clinical outcomes.|||events|||Number
1227473|NCT00684021|Primary|Global Left Ventricular Function|Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in Global EF from baseline to six months."|||percentage of ejection fraction||Standard Deviation|Mean
1227474|NCT00683930|Secondary|Duration of Prednisone Maintenance Dosing|The duration of prednisone maintenance dosing was defined as the number of days that subjects maintained a prednisone dose of not more than 10 mg/day in the absence of new persistent lesions.|52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day = 21; MMF 3 g/day = 37; MMF Groups Combined (2 g/day or 3 g/day) = 58.|||Days||Inter-Quartile Range|Median
1227475|NCT00683930|Secondary|Time to Sustained Response|Time to sustained response is defined as the week the subject first demonstrates both of the conditions of responder status provided the conditions are maintained through to study termination at Week 52. If a subject does not have a sustained response, time to sustained response is censored on the last day of the study.|up to 52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 20; MMF 2 g/day or 3 g/day = 58, subjects censored = 23.|||Weeks||Full Range|Median
1227476|NCT00683930|Secondary|Time to Initial Response|Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)|up to 52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 7; MMF 2 g/day or 3 g/day = 58, subjects censored = 10.|||Weeks||Inter-Quartile Range|Median
1227477|NCT00683930|Primary|Percentage of Patients Achieving Responder Status at Week 52|The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group|52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day or 3 g/day = 58.|||Percentage of Participants|||Number
1227478|NCT00683917|Primary|The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.||4 months|Study prematurely terminated||||||
1227481|NCT00683904|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||ng*h/mL||Standard Deviation|Geometric Mean
1227482|NCT00683904|Secondary|Time of Maximum Observed Plasma Concentration of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||Hours||Standard Deviation|Mean
1227483|NCT00683904|Secondary|Maximum Observed Plasma Concentration of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||ng/mL||Standard Deviation|Geometric Mean
1227484|NCT00683904|Secondary|Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment|Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met.|Days 1 through 21 (Cycle 1)|All treated participants with measurable disease at baseline, as determined by investigator|||Participants|||Number
1227485|NCT00683904|Secondary|Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status|Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair.|At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)||||Participants|||Number
1227486|NCT00683904|Secondary|Number of Participants With Abnormalities in Blood Pressure and Heart Rate|Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE.|At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)||||Participants|||Number
1227487|NCT00683904|Secondary|Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade|Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry.|At screening and Days 8 and 15 of Cycle 1 (21 days)||||Participants|||Number
1227488|NCT00683904|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade|ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L)|At screening and Days 8 and 15 of Cycle 1 (21 days)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
1227489|NCT00683904|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade|"LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365)~Appendix 7.1.2"|At screening and Days 8 and 15 of Cycle 1 (21 days)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
1227490|NCT00683904|Secondary|Number of Participants With Grade 3 or Greater Treatment-related AEs|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.|Days 1 through 21 (Cycle 1)|All subjects who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
1227491|NCT00683904|Secondary|Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation|An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
1227492|NCT00683904|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2|The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||mg/min/mL|||Number
1227493|NCT00683904|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
1227494|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF) among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2|||kg||Standard Error|Mean
1227495|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in waist circumference at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing waist circumference values at baseline and Week 24 (LOCF)|||cm||Standard Error|Mean
1227496|NCT00683878|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||Percentage of participants||Standard Error|Mean
1227497|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1227498|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
1227499|NCT00683878|Secondary|Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1227500|NCT00683878|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
1228310|NCT00677833|Secondary|Nadir Hemoglobin Level|Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.|Day 0 through Day 3|mITT population, including participants in the Ivory Coast center.|||grams per deciliter (g/dL)||Standard Deviation|Mean
1227501|NCT00683852|Other Pre-specified|Number of Patients With Treatment Emergent AEs in Two Treatment Groups - People Exclusively on Drug or Placebo Throughout the Study|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis compared AEs between the arms that received exclusively drug throughout the study or placebo throughout the study.|12 Weeks||||Patients|||Number
1227502|NCT00683852|Other Pre-specified|Number of Patients With Treatment Emergent AEs in Two Treatment Groups - Placebo Non-Responders|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis focused on placebo non-responders in phase 1 and presented them by their treatment assignment in phase 2.|12 Weeks|Of the 138 phase 1 placebo non-responders, 14 dropped out in phase 2: 9 in the drug arm and 5 in the placebo arm. Therefore, 124 total placebo non-responders from phase 1 were included in the analysis.|||Patients|||Number
1227503|NCT00683852|Other Pre-specified|Treatment Emergent AEs in Two Treatment Groups - Safety Sample|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. In this analysis, AEs were summarized according to person-phase of occurrence. Each AE was attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset.|12 Weeks|AEs were summarized according to person-phase of occurrence. Each AE will be attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset. If the severity or other characteristic of the AE changes between phases, it can be counted in both phases. Also see Table 5 in Reference.|||adverse events|participant-phases||Number
1227504|NCT00683852|Secondary|Mean Change in Symptom Questionnaire (SQ)|The SQ, a 92-item (yes/no) self-rating questionnaire, includes 4 distress and 4 well-being subscales. There are 68 items for the distress subscales and 24 items for the well-being subscales. Each item has either a Yes/No or True/False answer. For the distress symptom score, add together the following items and score 1 when the answer is Yes/True: 1, 2, 3, 5, 6, 8, 11, 12, 15, 18, 20, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 36, 37, 39, 41, 42, 44, 45, 47, 48, 49, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 79, 80, 81, 82, 84, 85, 86, 87, 88, 90, 91, 92. Minimum score is 0 and maximum score is 68. A higher score indicates more distress symptoms. For the well-being subscale score, add together the following items and score 1 when the answer is No/False: 4, 7, 9, 10, 13, 14, 16, 17, 19, 21, 23, 29, 31, 35, 38, 40, 43, 46, 50, 51, 71, 78, 83, 89. Minimum score is 0 and maximum score is 24. A higher score indicates more well-being.|Baseline and 12 weeks|This analysis used observed cases rather than LOCF (last observation carried forward), so some participants were missing follow-up data.|||units on a scale||Standard Deviation|Mean
1227505|NCT00683852|Secondary|Mean Change in Clinical Global Impression of Severity (CGI-S)|The CGI-S scale was administered by clinicians based on assessment of the patient’s clinical status. They measured, based on history and scores on other instruments, depressive severity. It consists of one question scored on a seven-point scale (1 = normal to 7 = among the most severe), so a higher total score indicates greater depressive severity. The minimum score is 1, and the maximum score is 7.|Baseline and 12 weeks|This analysis used observed cases rather than LOCF (last observation carried forward), so some participants were missing follow-up data.|||units on a scale||Standard Deviation|Mean
1227506|NCT00683852|Secondary|Mean Change in MADRS (Montgomery-Asberg Depression Rating Scale) Score From Baseline to the End of Follow-up|The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|Baseline and 12 Weeks||||units on a scale||Standard Deviation|Mean
1227507|NCT00683852|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Readmission Rate|MADRS readmission rate is defined as MADRS score<11. The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|12 weeks||||Participants|||Count of Participants
1227508|NCT00683852|Primary|MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate|The primary outcome was the difference in response rate (decrease in MADRS total score of at least 50%) using the SPCD (sequential parallel comparison design). The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|12 weeks||||Participants|||Count of Participants
1227509|NCT00683826|Primary|Weight||at the end of each study treatment arm (six weeks)|||||||
1227510|NCT00683826|Secondary|Energy Expenditure||will be measure at the end of each treatment period (6 weeks)|||||||
1227511|NCT00683826|Primary|Effects on Weight||4 weeks||||kilograms||Standard Deviation|Mean
1227512|NCT00683800|Other Pre-specified|Number of Participants With Hepatic Events|Hepatic events were defined as incidence of increased Liver Function Test (AST [aspartate aminotransferase] or ALT [alanine aminotransferase]) levels greater than 5 times the ULN (upper limit of normal).|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1227513|NCT00683800|Other Pre-specified|Number of Participants With Ischemic Heart Disease|"Potential ischaemic cardiac events were identified using the Standardized MedDRA Query (SMQ) Ischemic Heart Disease."|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1227514|NCT00683800|Other Pre-specified|Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA|Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for “central nervous system haemorrhages and cerebrovascular conditions”. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1227515|NCT00683800|Other Pre-specified|Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke|Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for “central nervous system haemorrhages and cerebrovascular conditions”. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1227516|NCT00683800|Secondary|Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
1227517|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 6|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
1227518|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Week 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
1227519|NCT00683800|Secondary|Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
1227520|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
1227521|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
1227522|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
1227523|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 6|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
1227524|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Week 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
1227698|NCT00682786|Post-Hoc|Toxicities by Genotype Group (Good Risk Versus Poor Risk)|Grade 3 to 4 toxicities related to treatment and surgery using CTC Version 2.0.|First day of treatment through 30 days after completion of surgery|Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
1227525|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
1227526|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
1227527|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
1227528|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.|||Units on a Scale||Standard Error|Mean
1227529|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.|||Units on a Scale||Standard Error|Mean
1227530|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy Greene Climacteric Scale (GCS) assessment or at least 1 on therapy Patient Global Impression (PGI) assessment.|||Units on a Scale||Standard Error|Mean
1227531|NCT00683800|Secondary|Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12|Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases.|Baseline, Month 6 and Month 12|MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Units on a Scale||Standard Error|Mean
1227532|NCT00683800|Secondary|Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases.|Baseline, Month 6 and Month 12|MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Hot Flushes||Standard Error|Mean
1227699|NCT00682786|Secondary|Determine Patient Fears and Expectations of Pharmacogenetics.|The questionnaire is encouraged but not required.|Prior to start of study treatment and 3-6 weeks post completion of radiation therapy|The data was not collected for this outcome measure as the questionnaire was encouraged but not required.||||||
1227533|NCT00683800|Secondary|Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes|Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days.|Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy.|||Days||95% Confidence Interval|Median
1227534|NCT00683800|Secondary|Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline, Week 4 and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Percentage of participants|||Number
1227535|NCT00683800|Secondary|Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline, Week 4 and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Percentage of participants|||Number
1227536|NCT00683800|Secondary|Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes|A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Participants|||Number
1227537|NCT00683800|Primary|Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events|Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1227538|NCT00683800|Primary|Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12|Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Mean
1227539|NCT00683800|Primary|Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4|Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.|Baseline and Week 4|MITT population: All participants randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using LOCF method. 1 participant in each group did not have data till Week 4.|||Units on a Scale||Standard Error|Mean
1227540|NCT00683800|Primary|Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Hot Flushes||Standard Error|Mean
1227541|NCT00683800|Primary|Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline and Week 4|Modified Intent-to-Treat(MITT) population: Participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks. Last observation carried forward (LOCF) method was used. 1 participant in each group did not have data till Week 4.|||Hot Flushes||Standard Error|Mean
1227549|NCT00683696|Secondary|Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)|"Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.~This composite endpoint used a weighted scoring scale based on the African-American Heart Failure Trial (A-HeFT) study Endpoint Score. (Taylor, AL, Ziesche, S, Yancy, C, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. N Engl J Med 2004; 351:2049-57.)~Composite Endpoint Scoring:~Vital Status:~Death (-3),~Survival to end of trial (0),~Hospitalization:~1st hospitalization for HF (-1),~No hospitalization (0),~QOL score:*~Improvement by ≥ 10 units (+2),~Improvement by 5-9 units (+1),~Change by < 5 units (0),~Worsening by 5-9 units (-1),~Worsening by ≥ 10 (-2).~Possible total score -6 to +2.~*QOL score details are provided in Secondary Outcome Measure 5."|Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)|Subjects with a potential of 24 months of follow-up.|||Composite score||Standard Deviation|Mean
1227550|NCT00683696|Secondary|Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up|Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. Therefore, a negative change in QOL score from baseline to 6 months represents an improvement in quality of life, while a positive change in QOL score from baseline to 6 months represents a worsening in quality of life.|Changes between baseline and 6 months|Subjects with Baseline & 6-month QOL scores. 25 subjects (15 CRT ON, 10 CRT OFF) that were in the study at least 6 months and that did not have 6-month QOL data, had 3-month data inputted using the LOCF principle.|||units on a scale||Standard Deviation|Mean
1227551|NCT00683696|Secondary|New York Heart Association (NYHA) Classification Change|"Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.~NYHA classes:~Class I - Subjects with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation,dyspnea, or anginal pain.~Class II - Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III - Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV - Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|Subjects with Baseline & 6-month NYHA classification. 18 subjects (9 CRT ON, 9 CRT OFF) that were in the study at least 6 months and that did not have 6-month NYHA data, had the most recent post-randomization NYHA inputted using the Last Observation Carried Forward (LOCF) principle.|||Participants|||Count of Participants
1227552|NCT00683696|Secondary|Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)|Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).|Study duration from randomization to study exit||||Hospitalizations per subj-yr|||Number
1227553|NCT00683696|Primary|Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)|The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.|6 months|The primary safety endpoint included all subjects undergoing an implant procedure.|||participants|||Number
1227554|NCT00683696|Primary|Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death|The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.|From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years|This analysis was carried out according to the intention-to-treat principle. Follow-up was censored at study closure, date of death, LVAD, heart transplant, withdrawal from the study, or loss to follow-up, whichever came first. 4 deaths in CRT OFF group and 1 death in CRT ON group were after LVAD/transplant and are not included in this analysis.|||participants|||Number
1227555|NCT00683657|Secondary|Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4|Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
1227556|NCT00683657|Secondary|Change From Baseline in Mean Daily Glucose at Week 4|Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
1227557|NCT00683657|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4|Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
1227558|NCT00683657|Secondary|Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4|Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
1227559|NCT00683657|Primary|Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4|Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
1227560|NCT00683644|Secondary|Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment|Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance)|baseline and 4 months|Subjects that complete 4 months treatment|||units on a scale||Standard Deviation|Mean
1227561|NCT00683644|Secondary|Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment|Participants should rate their tinnitus loudness on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception).|baseline and 4 months|Subjects that complete 4 months treatment|||units on a scale||Standard Deviation|Mean
1227562|NCT00683644|Primary|Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months|Validated questionnaire of tinnitus reactions. Scale 0 (no tinnitus reaction)- 100 (worst tinnitus reaction). Our primary outcome was the difference scores between Tinnitus Handicap Questionnaire (THQ) on baseline and end of treatment on zinc and placebo treatment. As stated by Newman et al., the test-retest variability was 20%, and difference scores greater than this should be considered a significant reduction. Therefore, changes on the difference scores of 20 or greater were considered as a statistically significant and therefore clinically meaningful improvement for THQ. The minimum score is zero and the maximum is 100. 0 is better and 100 is worse. This applies to all outcome measures.|baseline - 4 months|For data analysis purposes subjects were recombined in 2 groups (Zinc and Placebo). Group ZINC: subjects who completed 4 months with Zinc 50 mg daily either from baseline to month 4, or after washout (from month 5 to 9). Group PLACEBO: subjects who completed 4 months with placebo either from baseline to month 4, or after washout (from month 5 to 9)|||units on a scale||Standard Deviation|Mean
1227563|NCT00683618|Secondary|Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)"|from week 6 to week 12|Patients did not achieve NCEP ATP III LDL-C goal at the end of 6 weeks randomised treatment period, they entered into extension treatment period upon investigator’s discretion.|||percentage of patients|||Number
1227564|NCT00683618|Secondary|6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL); non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL),non-HDL-C goal < 3.36mmol/L (130mg/dL)"|week 6|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percentage of patients|||Number
1227565|NCT00683618|Secondary|Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)"|week 6|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percentage of patients|||Number
1227566|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227567|NCT00683618|Secondary|Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227568|NCT00683618|Secondary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227569|NCT00683618|Secondary|Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227570|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227571|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227572|NCT00683618|Secondary|Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227573|NCT00683618|Secondary|Percentage Change From Baseline in Triglycerides (TG) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||Percent change||Standard Error|Least Squares Mean
1227574|NCT00683618|Secondary|Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227575|NCT00683618|Secondary|Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
1227576|NCT00683618|Primary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.|baseline, 6 weeks||||Percent change||Standard Error|Least Squares Mean
1227577|NCT00683618|Primary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.|baseline, 6 weeks||||percent change||Standard Error|Least Squares Mean
1227578|NCT00683592|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8|MADRS remission was defined as a MADRS total score < 10 at Week 8. The remission rate is the percentage of subjects in each treatment group who met the criteria for remission. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Participants|||Number
1227579|NCT00683592|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8|MADRS response was defined as ≥ 50% decrease from baseline in MADRS total score at Week 8. The response rate is the percentage of subjects in each treatment group meeting the criteria for response. The method of last observation carrier forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Participants|||Number
1228329|NCT00677820|Secondary|Number of Subjects Reporting Any AEs Post Treatment||Days 0-14|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
1227580|NCT00683592|Secondary|Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score|The HAM-A is a rating scale developed to quantify the severity of anxiety. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Change from baseline in the HAM-A total score may range from -52 to 52 with negative value indicating improvement in anxiety symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1227581|NCT00683592|Secondary|The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8|The CGI-I scale measures change from the baseline state at every visit after the baseline visit. It permits a global evaluation of the patient’s improvement over time. At the scheduled clinic visits, the clinician assessed the patient’s improvement relative to the symptoms at baseline on a CGI-I item using a 7-point scale, where 1 = very much improved and 7 = very much worse. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1227582|NCT00683592|Secondary|Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score|The HAM-D 17 is a 17-item subscale of the HAM-D 21, which is designed to be completed by a trained rater. It is designed for rating depressive symptom severity in patients with a confirmed diagnosis of depressive disorder. The change in HAM-D 17 has a possible range of -52 to 52 with negative values indicating improvment in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, week 1, week 2, week 4, week 6, week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1227583|NCT00683592|Primary|Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.|The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1227584|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 30|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 30|Zero participants were analyzed.||||||
1227585|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 16|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 16|Zero participants were analyzed.||||||
1227586|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 15|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 15|Zero participants were analyzed.||||||
1227587|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 1|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 1|Zero participants were analyzed.||||||
1227588|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 30|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 30|Zero participants were analyzed.||||||
1227589|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 16|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 16|Zero participants were analyzed.||||||
1227590|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 15|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 15|Zero participants were analyzed.||||||
1227591|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 1|"Maximum Concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 1|Zero participants were analyzed.||||||
1227592|NCT00683475|Secondary|Objective Response Rate (ORR)|"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.~Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100."|Baseline to date of progressive disease or death up to 36.3 months|Participants with measurable disease at baseline, who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1227593|NCT00683475|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive.|First dose to death due to any cause up to 36.3 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. Twelve participants were censored in the IMC-1121B + Mitoxantrone + Prednisone arm"|||months||95% Confidence Interval|Median
1227594|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 12-months|"Data presented are the percentage of participants without disease progression at 12 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|12 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1227595|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 9-months|"Data presented are the percentage of participants without disease progression at 9 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|9 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1227596|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 6-months|"Data presented are the percentage of participants without disease progression at 6 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|6 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1227597|NCT00683475|Secondary|Prostate Specific Antigen (PSA) Response Rate|PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline.|Baseline up to data cut-off date (up to 36.3 months)|Participants who received any quantity of study drug, had baseline PSA value >= 2 ng/ml and at least one non-missing post-baseline PSA.|||percentage of participants||95% Confidence Interval|Number
1227598|NCT00683475|Secondary|Time to Radiographic Evidence of Disease Progression|"Time between date of randomization and earliest date of radiographic progression defined as either:~Tumor progression by RECIST;~Evidence of progression by bone scan;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).~Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy."|Randomization to date of radiographic progression, up to 36.3 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~34 participants were censored in IMC-A12 arm and 34 participants were censored in IMC-1121B (ramucirumab) arm."|||months||95% Confidence Interval|Median
1227599|NCT00683475|Secondary|Summary Listing of Participants Reporting Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Randomization to 36.3 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||participants|||Number
1227600|NCT00683475|Primary|Composite Progression-free Survival (cPFS)|"Defined as the median time from randomization to the earliest of:~Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);~Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)~Symptomatic progression (for participants without measurable disease);~Other clinical events attributable to prostate cancer that require major interventions; or~Death from any cause~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|Randomization to composite progressive disease, up to 23.4 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~11 participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. 15 participants were censored in the IMC-1121B (ramucirumab) + Mitoxantrone + Prednisone arm."|||months||95% Confidence Interval|Median
1227601|NCT00683449|Secondary|Hospital Admission Rate During Visit 1|After a patient in the emergency department (ED) presents with an acute exacerbation of asthma, the hospital proceeds with SOC procedures for this condition. Despite treatment in the ED, it is sometimes necessary to admit the patient into the hospital. In the study described here, the rate of hospital admissions was recorded.|Hour -1.5 through Hour 5||||participants|||Number
1227602|NCT00683449|Secondary|FEV1 (L) The Forced Expiratory Volume in One Second as Measured in Liters Per Second.|FEV1 (L) was determined over time using a spirometer. Measure the mean change in FEV1 (L) from Baseline.|Baseline to Hour 2|29 subjects experiencing an acute exacerbation of asthma were at approximately 8 ED sites. The sample size was based on feasibility and precedent for this type of study, rather than statistical considerations.|||liters per second||Full Range|Mean
1227700|NCT00682786|Secondary|Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.|The questionnaire is encouraged but not required.|Prior to start of study treatment and 3-6 weeks post completion of radiation therapy|The data was not collected for this outcome measure as the questionnaire was encouraged but not required.||||||
1227603|NCT00683449|Primary|Change of FEV1 (Forced Expiratory Volume in 1 Second) Expressed as Percent of Predicted After Two Doses of Albuterol (5 mg Each) and Ipratropium (0.5 mg Each) When Compared to FEV1 at Hour 2 After the Start of the Infusion of MN-221 or Placebo.|The primary efficacy summary was change from Baseline in FEV1 (percent predicted), at Hour 2. Baseline was defined as FEV1 (percent predicted) after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) and FEV1 (percent predicted) FEV1 at Hour 2 was defined as the FEV1 (percent predicted) at 2 hours after the start of the infusion of MN-221 or placebo. Change from Baseline in FEV1 (percent predicted), was summarized by treatment group at Hour 2.|Baseline and Hour 2|The analysis was performed on the Intention-to-Treat (ITT) population. Twenty-nine subjects met the study entry criteria, provided written informed consent, and were enrolled in the study.|||FEV1 (percent of predicted)||Full Range|Mean
1227604|NCT00683410|Primary|Number of Participants With Spontaneous Adverse Events||30 days post injection up to 3 years|Safety Analysis set - all participants who received at least one dose of Prevenar|||Participants|||Number
1227605|NCT00683384|Primary|Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection||30 days post injection up to 3 years|Full analysis set|||Participants|||Number
1227606|NCT00683332|Primary|Number of Participants With Spontaneous Adverse Events|"Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: How have you been feeling since your last visit?"|30 days post injection up to 3 years|Safety Population: All participants who received at least 1 dose of tygacil|||Participants|||Number
1227607|NCT00683293|Secondary|Complications||up to 2 weeks||||participants|||Number
1227608|NCT00683293|Primary|Duration of Surgery|•Mean Time to complete surgery from cut to suture|after surgey||||minutes||Standard Deviation|Mean
1227609|NCT00683163|Secondary|Change From Baseline in Trabecular Spine vBMD|Areal bone mineral density (aBMD) at the lumbar spine, hip, and distal one-third radius was assessed by dual-energy X-ray absorption at baseline and 6, 12, 18, and 24 months. The precision for aBMD is 1.0%. Volumetric BMD and bone geometry in trabecular and cortical compartments were assessed by quantitative computed tomography (QCT) at the spine and hip. The left hip was used for analysis. The precision for trabecular spine vBMD measurement is 1.0%. Trabecular spine vBMD was our primary BMD outcome, thus the one presented here.|Baseline, 24 months.||||Percent change from baseline||Standard Deviation|Mean
1227610|NCT00683163|Primary|P1NP (ng/ml) Change From Baseline.|After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.|Baseline, 3 months|Analyses were performed according to intention-to-treat principle. A sample size of 20 participants per group was estimated to provide 80% power to detect a change of 25ng/mL in PINP, assuming the SD of 40ng/mL observed previously with concurrent PTH(1-84) and daily alendronate.|||Percent change from baseline||95% Confidence Interval|Geometric Mean
1227611|NCT00683085|Secondary|Number of Participants With Tumor Regression|Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.|2 months|intension to treat (ITT)|||participants|||Number
1227612|NCT00683085|Primary|Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events|Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)|2 months|Intention to treat (ITT)|||participants|||Number
1227613|NCT00683046|Secondary|Median Overall Survival|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"|Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years||||Days||95% Confidence Interval|Median
1227614|NCT00683046|Primary|Median Disease-free Survival|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"|Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years||||Days||95% Confidence Interval|Median
1227615|NCT00683020|Secondary|Changes in Diastolic Blood Pressure (DBP)|Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood. Change is calculated as 6-month pressure minus baseline pressure.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||mm Hg||Standard Error|Least Squares Mean
1227616|NCT00683020|Secondary|Changes in Systolic Blood Pressure (SBP)|Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body. Change is calculated as 6-month pressure minus baseline pressure.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||mm Hg||Standard Error|Least Squares Mean
1227727|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 12|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
1227617|NCT00683020|Secondary|Changes in Hemoglobin A1c Levels|Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement. Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease. Change is calculated as 6-month level minus baseline level.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||percentage||Standard Error|Least Squares Mean
1227618|NCT00683020|Secondary|Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale|The Interpersonal Processes of Care (IPC) is an 18-item patient report instrument that measures patients’ perspectives on the structure of their care and collects patient reports on providers’ communication over the prior 6 months. The scale is intended to measure patients’ assessment of providers’ communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness). Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Higher total scores indicate better communication. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
1227619|NCT00683020|Secondary|Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale|The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients’ perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past 6 months that are aligned with the Chronic Care Model. The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support. Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Scores are transformed to a 100-point scale (0-100) and averaged across all items to create a total scale score. Higher transformed and total scale scores indicate better care. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
1227620|NCT00683020|Secondary|Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale|The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project. The scale is designed to reflect patients’ assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care). Respondents are asked how difficult over the past 6 months has it been to follow exactly as their doctor who takes care of their diabetes suggested. Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy. Total scale score is calculated as the average across all items. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
1227621|NCT00683020|Secondary|Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale|The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure’s author’s recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
1227622|NCT00683020|Secondary|Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale|The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure’s author’s recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
1233769|NCT00631488|Primary|Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||mg/dL||Standard Error|Least Squares Mean
1227623|NCT00683020|Secondary|Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities|A measure of diabetes interference on patients is ascertained by asking patients the following question: “In the last 6 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?” Responses consist of 6 possible options: “Always”, “Almost Always”, “Often”, “Sometimes”, “Almost Never”, and “Never”. These responses are grouped into 2 categories, with one category consisting of “Always”, “Almost Always”, and “Often” responses while the other category consists of the remaining responses. The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.|6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||proportion of patients|||Number
1227624|NCT00683020|Secondary|Number of Days Spent in Bed Due to Illness|A measure of patients’ functional status is ascertained by asking patients the following question: “In the last 30 days, how many days did health problems keep you in bed for all or most of the day?” Number of days may range from 0 to 30, with lower number of days indicating better functional status. Because a negative binomial model was used to analyze the data for number of days spent in bed due to illness, log means are reported. A log mean is the natural (base e) logarithm of the mean (in this context specifically, the mean number of days spent in bed due to illness). To calculate the mean, one raises e by the number given as the log mean. Lower log means indicate better functional status.|6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||log days||95% Confidence Interval|Mean
1227625|NCT00683020|Primary|Changes in the Mental Component Summary of the SF-12 Health Survey|The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
1227626|NCT00683020|Primary|Changes in the Physical Component Summary of the SF-12 Health Survey|The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
1227627|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score|The Modified Social Support Scale is an 18-item scale developed as a measure of perceived social support. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates greater perceived support. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in perceived support and correlates to a better outcome. A negative result indicates a decrease in perceived support and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Modified Social Support scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227628|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score|The Modified Social Support Scale is an 18-item scale developed as a measure of perceived social support. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates greater perceived support. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in perceived support and correlates to a better outcome. A negative result indicates a decrease in perceived support and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Modified Social Support scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227629|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score|The Mental Health Inventory (MHI) is an 18-item scale developed as a measure of overall emotional functioning. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates better mental health. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in mental health and correlates to a better outcome. A negative result indicates decrease in mental health and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 14 subjects completed all Mental Health Inventory questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure. The Mental Health Inventory was added late to the study beginning with subject 22 of 42|||units on a scale||Standard Deviation|Mean
1227630|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score|The Mental Health Inventory (MHI) is an 18-item scale developed as a measure of overall emotional functioning. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates better mental health. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in mental health and correlates to a better outcome. A negative result indicates decrease in mental health and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through Wk 7; 2 subjects who discontinued early (AE & withdraw by subject) were active at Wk 3 and were included in the Wk 3 analysis; 14 subjects completed all MHI questions at both the Wk 0 and Wk 3 and were analyzed for this outcome measure. The MHI was added late to the study beginning with subject 22 of 42|||units on a scale||Standard Deviation|Mean
1227631|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score|The Perceived Deficits Scale is a 20-item scale developed to assess the patient's perceived cognitive deficits. It is composed of four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-80. The scale is set up so that a higher score indicates greater perceived cognitive impairment. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the perception of cognitive impairment. A positive result indicates an increase in the perception of cognitive impairment. Since patient perceptions of cognitive impairment may not correlate with objective measures of cognitive impairment, the results should be interpreted with caution.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Perceived Deficits scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227632|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score|The Perceived Deficits Scale is a 20-item scale developed to assess the patient's perceived cognitive deficits. It is composed of four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-80. The scale is set up so that a higher score indicates greater perceived cognitive impairment. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the perception of cognitive impairment. A positive result indicates an increase in the perception of cognitive impairment. Since patient perceptions of cognitive impairment may not correlate with objective measures of cognitive impairment, the results should be interpreted with caution.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Perceived Deficits scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227633|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score|The Impact of Visual Impairment Scale is a 5-item scale developed to assess the extent to which activities dependent on vision are affected by MS-related visual problems. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-15. The scale is set up so that a higher score indicates greater impact of visual problems on daily activities. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of visual problems on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of visual problems on daily activities and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects completed all Impact of Visual Impairment scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227634|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score|The Impact of Visual Impairment Scale is a 5-item scale developed to assess the extent to which activities dependent on vision are affected by MS-related visual problems. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-15. The scale is set up so that a higher score indicates greater impact of visual problems on daily activities. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of visual problems on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of visual problems on daily activities and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Impact of Visual Impairment scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227635|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score|The Bowel Control Scale is a 5-item scale developed to assess the impact of multiple sclerosis on bowel function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-26. The scale is set up so that a higher score indicates greater bowel control problems. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in bowel control and correlates to a better outcome. A positive result indicates a decrease in bowel control and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects completed all Bowel Control scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227702|NCT00682786|Primary|Rate of Tumor Downstaging Compared With Historical Controls.|"Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1.~Historical studies demonstrate a DS rate of 45%."|1 year after enrollment|"8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX~6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician"|||percentage of participants||95% Confidence Interval|Number
1227636|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score|The Bowel Control Scale is a 5-item scale developed to assess the impact of multiple sclerosis on bowel function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-26. The scale is set up so that a higher score indicates greater bowel control problems. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in bowel control and correlates to a better outcome. A positive result indicates a decrease in bowel control and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Bowel Control scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227637|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score|The Bladder Control Scale is a 4-item scale developed to assess the impact of multiple sclerosis on bladder function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-22. The scale is set up so that a higher score indicates greater bladder control problems. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in bladder control and correlates to a better outcome. A positive result indicates a decrease in bladder control and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects completed all Bladder Control scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227638|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score|The Bladder Control Scale is a 4-item scale developed to assess the impact of multiple sclerosis on bladder function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-22. The scale is set up so that a higher score indicates greater bladder control problems. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in bladder control and correlates to a better outcome. A positive result indicates a decrease in bladder control and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Bladder Control scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227639|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score|"The Sexual Satisfaction Scale is a 4-item scale developed to assess the impact of multiple sclerosis on sexual function and satisfaction. It is a part of the MS Quality of Life Inventory. The scale is measured from 4-24. The scale is set up so that a higher score indicates greater problems with sexual satisfaction. Subjects that answered No to the question, Do you have a relationship with one primary partner, did not complete the scale. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in sexual satisfaction and correlates to a better outcome. A positive result indicates a decrease in sexual satisfaction and correlates to a worse outcome."|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 19 subjects completed all Sexual Satisfaction scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227640|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score|"The Sexual Satisfaction Scale is a 4-item scale developed to assess the impact of multiple sclerosis on sexual function and satisfaction. It is a part of the MS Quality of Life Inventory. The scale is measured from 4-24. The scale is set up so that a higher score indicates greater problems with sexual satisfaction. Subjects that answered No to the question, Do you have a relationship with one primary partner, did not complete the scale. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in sexual satisfaction and correlates to a better outcome. A positive result indicates a decrease in sexual satisfaction and correlates to a worse outcome."|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 19 total subjects completed all Sexual Satisfaction scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227641|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score|The Pain Effects Scale is a 6-item scale developed to assess the effects of pain on behavior and mood. It is a part of the MS Quality of Life Inventory. The scale is measured from 6-30. The scale is set up so that a higher score indicates a greater impact of pain on a patient's mood and behavior. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of pain on mood and behavior and correlates to a better outcome. A positive result indicates an increase in the impact of pain on mood and behavior and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects completed all Pain Effects scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227642|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score|The Pain Effects Scale is a 6-item scale developed to assess the effects of pain on behavior and mood. It is a part of the MS Quality of Life Inventory. The scale is measured from 6-30. The scale is set up so that a higher score indicates a greater impact of pain on a patient's mood and behavior. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of pain on mood and behavior and correlates to a better outcome. A positive result indicates an increase in the impact of pain on mood and behavior and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects completed all Pain Effects scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227643|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score|The Modified Fatigue Index is a 21-item scale developed to assess the perceived impact of fatigue on daily activities. It is a part of the MS Quality of Life Inventory. The scale is measured from 0 - 84. The scale is set up so that a higher score indicates a greater impact of fatigue on a patient's daily activities. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of fatigue on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of fatigue on daily activities and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Modified Fatigue Index questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227644|NCT00682929|Secondary|Change From Week 0 to Week3 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score|The Modified Fatigue Index is a 21-item scale developed to assess the perceived impact of fatigue on daily activities. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-84. The scale is set up so that a higher score indicates a greater impact of fatigue on a patient's daily activities. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of fatigue on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of fatigue on daily activities and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Modified Fatigue Index questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227645|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component|The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0. A positive result indicates an improvement in mental health status and correlates to a better outcome. A negative result indicates a decline in mental health and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 23 subjects completed all SF-36 mental component questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227646|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component Score|The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0. A positive result indicates an improvement in mental health status and correlates to a better outcome. A negative result indicates a decline in mental health and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 21 total subjects completed all SF-36 mental component questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227647|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score|The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in health status and correlates to a better outcome. A negative result indicates a decline in health and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 23 subjects completed all SF-36 physical component questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227648|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score|The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in health status and correlates to a better outcome. A negative result indicates a decline in health and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 21 total subjects completed all SF-36 physical component questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227649|NCT00682929|Secondary|Change From Week 0 to Week 7 in Expanded Disability Status Score (EDSS)|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The total EDSS score ranges from 0 to 10, in 0.5 unit increments. A score of 0 is the lowest (normal neurological exam) and 10 is the highest (death due to MS). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had completed & scored EDSS assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227650|NCT00682929|Secondary|Change From Week 0 to Week 3 in Expanded Disability Status Score (EDSS)|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The total EDSS score ranges from 0 to 10, in 0.5 unit increments. A score of 0 is the lowest (normal neurological exam) and 10 is the highest (death due to MS). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had completed & scored EDSS assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227651|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Cerebral|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebral score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (dementia). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome. Fatigue did not contribute to this FS score or the EDSS total score.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Cerebral assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227652|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Cerebral|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebral score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (dementia). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome. Fatigue did not contribute to this FS score or the EDSS total score.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Cerebral assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227653|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Bowel and Bladder|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Bowel and Bladder score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (loss of bowel and bladder function). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Bowel & Bladder assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227654|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Bowel and Bladder|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Bowel and Bladder score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (loss of bowel and bladder function). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Bowel & Bladder assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227655|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Sensory|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Sensory score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (sensation essentially lost below the head). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Sensory assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227703|NCT00682734|Primary|Pain Intensity Score|Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.|Baseline, 60 minutes|per protocol|||scores on a scale||Standard Deviation|Mean
1227656|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Sensory|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Sensory score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (sensation essentially lost below the head). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Sensory assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227657|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Cerebellar|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebellar score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (unable to perform coordinated movements due to ataxia). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Cerebellar assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227658|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Cerebellar|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebellar score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (unable to perform coordinated movements due to ataxia). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had FS Cerebellar assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227659|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Pyramidal|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Pyramidal score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (tetraplegia (grade 0 or 1 in all muscle groups of upper and lower limbs). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Pyramidal assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227660|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Pyramidal|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Pyramidal score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (tetraplegia (grade 0 or 1 in all muscle groups of upper and lower limbs). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Pyramidal assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227661|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Brainstem|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Brainstem score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (inability to swallow or speak). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Brainstem assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227726|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 14|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
1227662|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Brainstem|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Brainstem score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (inability to swallow or speak). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Brainstem assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227663|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Vision|"The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Vision score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (grade 5 plus maximal visual acuity of better eye of 20/60 (0.3) or less).~Higher values indicate more impaired vision. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in vision and correlates to a better outcome."|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Vision assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227664|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Vision|"The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Vision score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (grade 5 plus maximal visual acuity of better eye of 20/60 (0.3) or less).~Higher values indicate more impaired vision. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in vision and correlates to a better outcome."|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had FS Vision assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227665|NCT00682929|Secondary|Change From Week 0 to Week 7 in Paced Auditory Serial Addition Test (PASAT) Score|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability; The test is presented via recording on a CD to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test score is the number of correct sums given (out of a possible 60) in each trial. There are 2 test forms, A and B. The forms were alternated and at least 1 practice test (10 sums) was performed prior to each trial. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in performance and correlates with a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects had PASAT assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||number correct||Standard Deviation|Mean
1227666|NCT00682929|Secondary|Change From Week 0 to Week 3 in Paced Auditory Serial Addition Test (PASAT) Score|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability; The test is presented via recording on a CD to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test score is the number of correct sums given (out of a possible 60) in each trial. There are 2 test forms, A and B. The forms were alternated and at least 1 practice test (10 sums) was performed prior to each trial. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in performance and correlates with a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 29 total subjects had PASAT assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||number correct||Standard Deviation|Mean
1227667|NCT00682929|Secondary|Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time|"The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time.~A negative result indicates an improvement in arm and hand function and correlates with a better outcome."|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 25 subjects had 9 Hole Peg tests (non-dom. hand) performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
1227701|NCT00682786|Secondary|Complete Response Rates|"Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0).~Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0).~pCR rate of historical controls is 8%-14%."|1 year after enrollment|"8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX~6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician"|||percentage of participants|||Number
1227668|NCT00682929|Secondary|Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time|"The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The non-dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time.~A negative result indicates an improvement in arm and hand function and correlates with a better outcome."|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects had 9 Hole peg tests (non-dom. hand) at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
1227669|NCT00682929|Secondary|Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time|"The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time.~A negative result indicates an improvement in arm and hand function and correlates with a better outcome."|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had 9 Hole Peg tests (dominant hand) performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
1227670|NCT00682929|Secondary|Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time|"The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time.~A negative result indicates an improvement in arm and hand function and correlates with a better outcome."|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects had 9 Hole Peg tests (dominant hand) at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
1227671|NCT00682929|Primary|LIDO Machine Score - Rate of Torque Increase, Extension|A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had Lido assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||degrees/second||Standard Deviation|Mean
1227672|NCT00682929|Primary|Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion|A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had Lido assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||degrees/second||Standard Deviation|Mean
1227673|NCT00682929|Primary|Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension|A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; only 25 total subjects had Lido assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||degrees/second||Standard Deviation|Mean
1227674|NCT00682929|Secondary|Change From Week 0 to Week 7 in 25 Foot Walk Time|The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had 25 Foot Walk tests performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
1227675|NCT00682929|Secondary|Change From Week 0 to Week 3 in 25 Foot Walk Time|The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 22 total subjects had 25 Foot Walk tests performed at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
1227676|NCT00682929|Secondary|Change From Week 0 to Week 7 in Ambulation Index (AI) Score|The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects had Ambulation Index assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227677|NCT00682929|Secondary|Change From Week 0 to Week 3 in Ambulation Index (AI) Score|The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had Ambulation Index assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227678|NCT00682929|Secondary|Change From Week 0 to Week 7 in Modified Ashworth Score|The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had Ashworth assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1227679|NCT00682929|Secondary|Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)|The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had Ashworth assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on scale||Standard Deviation|Mean
1227680|NCT00682929|Primary|Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion|A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; only 25 total subjects had Lido assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||degrees/second||Standard Deviation|Mean
1227681|NCT00682890|Primary|Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)|Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790–800) and is reported with units min-1/(µlU/L).|baseline and 3 months||||min-1/(µlU/L)||Standard Deviation|Mean
1227747|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 12|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227682|NCT00682890|Primary|Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)|Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790–800) and is reported with units min-1/(µlU/L).|baseline and 3 months||||units on a scale||Standard Deviation|Mean
1227683|NCT00682851|Secondary|Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.|Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.|Visit 1||||Percentage of Participants||95% Confidence Interval|Number
1227684|NCT00682851|Secondary|Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.|Sensitivity of the BVBlue Test and Amsel criteria in diagnosing bacterial vaginosis using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.|Visit 1||||Percentage of Participants||95% Confidence Interval|Number
1227685|NCT00682851|Secondary|Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women|Specificity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.|Visit 1||||Percentage of Participants||95% Confidence Interval|Number
1227686|NCT00682851|Primary|Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women|Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.|Visit 1||||Percentage of Participants||95% Confidence Interval|Number
1227687|NCT00682838|Primary|Nightly CPAP Adherence|Nightly CPAP adherence hours per night measured over the three-months period|3 mos||||hours per night||Standard Deviation|Mean
1227688|NCT00682786|Post-Hoc|Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
1227689|NCT00682786|Post-Hoc|Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.|||participants|||Number
1227690|NCT00682786|Post-Hoc|Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
1227691|NCT00682786|Post-Hoc|Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.|||participants|||Number
1227692|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
1227693|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.|||participants|||Number
1227694|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
1227695|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|"Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.~MTHFR gene = methylenetetrahydrofolate reductase (NAD(P)H)"|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.|||participants|||Number
1227696|NCT00682786|Post-Hoc|Relapse-free Survival|Analyzed using Kaplan-Meier Models.|1 year, 2 years, and 3 years|"14 patients in the Good Risk arm had metastatic rectal cancer at time of enrollment are not included in this analyses.~3 patients in the Poor Risk arm had metastatic rectal disease before surgery and are included in this analyses.~2 of the patients in the Good Risk arm and Poork Risk arm withdrew consent and are not included."|||percentage of participants|||Number
1227697|NCT00682786|Post-Hoc|Overall Survival|Analyzed using Kaplan-Meier Models.|1 year, 2 years, and 3 years|Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included.|||percentage of participants|||Number
1228398|NCT00676793|Primary|Change in Serum VEGF in Breast Cancer|Change in serum VEGF from baseline to post treatment with polyphenon E.|Baseline and 4 to 6 weeks|Number of participants for analysis was determined per protocol.|||pg/ml||Inter-Quartile Range|Median
1227704|NCT00682643|Secondary|Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods|rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).|Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
1227705|NCT00682643|Secondary|Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104|"The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the cup portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology."|Baseline and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||percent change||Standard Deviation|Mean
1227706|NCT00682643|Secondary|Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104|ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the [decadic] logarithm of the minimum angle of resolution [range from +1.00 to -0.30]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
1227707|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline in IOP was calculated by subtracting the baseline value from the Week 104 value.|Baseline and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||participants|||Number
1227708|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 value.|Baseline and Week 52|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||participants|||Number
1227709|NCT00682643|Secondary|Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||mm Hg||Standard Deviation|Mean
1227710|NCT00682643|Secondary|Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104|Nuclear color is associated with the force required to compress a lens to 75% of its original depth. The range for NC is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NC was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
1227711|NCT00682643|Secondary|Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104|Nuclear opacity refers to the opacity in the central nucleus of the eye.The range for NO is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NO was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
1227712|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104|An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||participants|||Number
1227713|NCT00682643|Secondary|Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104|An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
1227714|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104|An event for P is defined as an increase of >=0.3 from baseline in LOCS III (classification system based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||participants|||Number
1227715|NCT00682643|Secondary|Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104|An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
1227716|NCT00682643|Primary|Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event|An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.|Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104|ITT Population. All participants with post-baseline ophthalmic examination data were included in the analysis for this endpoint.|||percentage of participants|||Number
1227717|NCT00682643|Primary|Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)|An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.|Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104|ITT Population. All participants (par.) with post-baseline ophthalmic examination data were included in the analysis for this endpoint. Par. without post-baseline ophthalmic exam data were censored at the randomization data. Par. who completed the study without an event for P or were discontinued for reasons other than an event for P were censored.|||Percentage of participants|||Number
1227718|NCT00682565|Secondary|Participants With 1 mm ST Segment Depression During ETT-3|ST Segment Depression measured by Electrocardiography while performing ETT-3.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3. However, majority of patients did not have ECGs assessable (per protocol) for 1 mm ST depression.|||Participants|||Number
1227719|NCT00682565|Secondary|Participants Stopping ETT-3 for Angina at Any Stage|"This Outcome Measure includes all participants who stopped ETT-3 for angina at any stage, not only those who stopped at a stage earlier than ETT-B.~Note: All 9 subjects who stopped ETT-3 for angina also stopped ETT-B for angina."|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.|||Participants|||Number
1227720|NCT00682565|Secondary|Increase in Exercise Duration During ETT-3 vs. ETT-B||1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.|||seconds||Standard Deviation|Mean
1227721|NCT00682565|Secondary|Participants Stopping ETT-3 for Any Reason at Stage Earlier Than ETT-B|The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.|||Participants|||Number
1227722|NCT00682565|Primary|Participants Stopping Exercise Treadmill Test 3 (ETT-3) for Angina at Stage Earlier Than Baseline Exercise Treadmill Test (ETT-B)|The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.|||Participants|||Number
1227723|NCT00682539|Secondary|To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.|Area of leakage and non perfusion is measured in FA, morphologic details like presence of cysts or sub retinal fluid is evaluated in OCT. Data is still under evaluation.|12 month||2016-06-30|06/2016||||
1227724|NCT00682539|Primary|Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)|Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome|12 months||||µm||Standard Deviation|Mean
1227725|NCT00682539|Primary|Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.|Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome|12 month||||logMAR||Standard Deviation|Mean
1228610|NCT00675428|Primary|Objective Response Rate (ORR)|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006).|Day 1 up to Month 6|ORR was not calculated because the study was terminated early.||||||
1227728|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 6|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
1227729|NCT00682461|Secondary|Percentage of Participants With Adverse Events|"Adverse Event=any untoward medical occurrence in a subject following administration of an investigational product, which did not necessarily have a causal relationship with this treatment.~Serious Adverse Event=any untoward medical occurrence that at any dose; results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect"|From baseline to Week 14|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
1227730|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 1|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
1227731|NCT00682435|Secondary|Change in Pain Intensity|Pain intensity is measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable) from baseline to 60 minutes after medication infused|60 minutes after medication infused||||units on a scale||Inter-Quartile Range|Median
1227732|NCT00682435|Secondary|Number of Patients With Reduction in Pain Intensity|Pain intensity is measured on the numerical rating scale (NRS), with a pain score from 0 (no pain) to 10 (worst pain imaginable). The reduction in pain intensity is defined here as a change in pain score by 2 or more units.|60 minutes after medication infused||||% of participants|||Number
1227733|NCT00682435|Primary|Number of Patients With Oxygen Desaturation Less Than 95%|primary safety outcome, defined as number of participants who experienced oxygen saturation < 95%|120 minutes after medication infused|Total of 223 split into patients who received only 1 mg of IV hydromorphone (179) and those who received 2 mg of IV hydromorphone|||Participants|||Count of Participants
1227734|NCT00682435|Primary|Number of Patients Who Had Adequate Analgesia|Adequate analgesia is defined as declining additional hydromorphone within 1 hour of entering the protocol|60 minutes after medication infused|Those given a second dose only included patients who wanted more pain medication 15 minutes after 1st dose. 7 patients did not receive the second dose, resulting in 44 patients analyzed instead of expected 51|||Participants|||Count of Participants
1227735|NCT00682357|Secondary|Change in Serum Cortisol|Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.|Change from Baseline Visit to Day 28||||mcg/dL||Standard Deviation|Mean
1227736|NCT00682357|Secondary|Change in Testosterone|Outcome represents the mean change in testosterone level from baseline visit to day 28.|Change from Baseline Visit to Day 28|Only males randomized to Group 1 - Standard Dose were included in this analysis.|||ng/dL||Standard Deviation|Mean
1227737|NCT00682357|Primary|Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)|Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.|Change from Baseline Visit to Day 28||||U/L||Standard Deviation|Mean
1227738|NCT00682357|Primary|Change in Serum Osteocalcin|Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.|Change from Baseline Visit to Day 28||||ng/mL||Standard Deviation|Mean
1227739|NCT00681889|Secondary|Efficacy by Measuring Mean Change of BCVA||Prospective|||||||
1227740|NCT00681889|Secondary|Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs||Prospective|||||||
1227741|NCT00681889|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||16 Weeks|||||||
1227742|NCT00681889|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing|16 Weeks|All participants enrolled into the study were analyzed.|||participants|||Number
1227743|NCT00681863|Secondary|Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters|Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis)|Baseline and 24 weeks|Observed Cases Treated set (OC TS). All participants in Treated Set having observed data at the particular timepoint.|||participants|||Number
1227744|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||participants|||Number
1227745|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 20|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227746|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 16|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1228733|NCT00674154|Secondary|Increased Bone Mineral Density||One year|||||||
1228734|NCT00674154|Secondary|Increase in Quality of Life||One year|||||||
1227748|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 8|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227749|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 4|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227750|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 3|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227751|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 2|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227752|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 1|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227753|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||participants|||Number
1227754|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 20|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227755|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 16|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227756|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 12|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227757|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 8|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227758|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 4|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227759|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 3|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227760|NCT00681863|Primary|Patients With Adverse Events Leading to Discontinuation of Trial Drug|Number of patients with Adverse Events leading to discontinuation of trial drug|24 Weeks|Treated set|||participants|||Number
1227761|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 2|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227762|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 1|This outcome measure was not analyzed due to the premature ending of the trial.||||||
1227763|NCT00681863|Secondary|Clinical Global Impressions - Severity of Illness, Categorized|"Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients).~Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement."|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||participants|||Number
1227764|NCT00681863|Secondary|Clinical Global Impressions - Severity of Illness|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||score on a scale||Standard Deviation|Mean
1227765|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 24|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227766|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 20|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227767|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 16|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227768|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 12|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227769|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 8|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227770|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 4|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227771|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 3|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227772|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 2|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227773|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 1|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227774|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 24|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227775|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 20|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227776|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 16|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227777|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 12|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227778|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 8|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227779|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and week 4|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227780|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 3|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227781|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 2|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1227782|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 1|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
1228330|NCT00677820|Secondary|Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14||Days 0-14|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
1227783|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 24 (end of treatment visit)|The Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).|||Score on a scale||Standard Deviation|Mean
1227784|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||Score on a scale||Standard Deviation|Mean
1227785|NCT00681824|Secondary|Number of Participants With Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria||within 1 month following surgery|"Primary Safety Data Set~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"|||participants|||Number
1227786|NCT00681824|Secondary|Incidence of Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria||within 1 month following surgery|"Primary Safety Data Set~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"|||percentage of participants||95% Confidence Interval|Number
1227787|NCT00681824|Primary|Number of Participants With Cerebrospinal Fluid (CSF) Leakage Observed After Surgery|"Study-relevant CSF leakage is defined as one or more of following:~Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2–transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)~Epidural CSF collection in surgical area depicted by CT or MRI~Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2–transferrin~Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage."|33 +/- 3 days after surgery|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~Two participants (FS VH S/D 500 s-apr arm) removed from analysis due to (1) subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy (2) withdrew from study"|||participants|||Number
1227788|NCT00681824|Secondary|Number of Participants With Procedures Resulting From the Treatment of CSF Leaks|The number of participants with surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures.|until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"|||participants|||Number
1227789|NCT00681824|Secondary|Incidence of Procedures Resulting From the Treatment of CSF Leaks|The incidence of surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures|until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"|||percentage of participants||95% Confidence Interval|Number
1227790|NCT00681824|Primary|Incidence of Cerebrospinal Fluid (CSF) Leakage Observed After Surgery|"Study-relevant CSF leakage is defined as one or more of following:~Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)~Epidural CSF collection in surgical area depicted by CT or MRI~Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin~Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage."|33 +/- 3 days after surgery|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~Two participants (FS VH S/D 500 s-apr arm) removed from analysis due to (1) subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy (2) withdrew from study"|||percentage of participants||95% Confidence Interval|Number
1227791|NCT00681811|Primary|Days of Exposure to HGT-1111|End of study was defined as until HGT-1111 was commercially available, the participant’s participation was discontinued, or the study was terminated by the Sponsor.|Baseline until end of study (Week 139)|Safety population was defined as all enrolled participants who received at least one study infusion (or any portion of a dose) of HGT-1111.|||Days||Standard Deviation|Mean
1227792|NCT00681811|Secondary|Score of Gross Motor Function Measurement (GMFM)|Gross motor function was measured using GMFM-88 at 6-month intervals. The GMFM-88 item scores were summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) to 264 (maximum). Decrease in GMFM score indicates disease progression.|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure."|||scores on a scale||Standard Deviation|Mean
1227793|NCT00681811|Secondary|Level of White Matter Metabolites|Level of white matter metabolites [N-acetyl Aspartate (NAA)] measured at 6-month intervals in HGT-MLD-049 (NCT00681811).|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure. No participants were analysed after Month 18, hence, data were not available after Month 18."|||nmol/L||Standard Deviation|Mean
1227794|NCT00681811|Secondary|Level of Cerebrospinal Fluid (CSF) Sulfatide|Level of CSF sulfatide measured at 6-month intervals in HGT-MLD-049 (NCT00681811).|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure."|||nanomole per liter (nmol/L)||Standard Deviation|Mean
1227795|NCT00681668|Secondary|Electrocardiogram (ECG), Vital Signs, Laboratory|"Safety parameter:s electrocardiogram (ECG), vital signs, laboratory~no participants analysed - terminated study"|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated|||participants|||Number
1228735|NCT00674154|Secondary|Reduced Postoperative Hypocalcemia||Postoperative week|||||||
1227796|NCT00681668|Secondary|Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)|Change in functional outcome: Global Assessment of Functioning (GAF),scale of 1-100 (1 = severe symptoms - 100 = no symptoms) Parental bonding Questionnaire (PBQ) no participants analysed - terminated study|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated|||scores on a scale||Full Range|Median
1227797|NCT00681668|Secondary|Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)|"Change in efficacy scales: Clinical Global Impression (CGI),Scale of 1-7 (1 = normal or no change - 7 = extremely ill or extreme changes).~Montgomery Asberg Depression Rating scale (MADRS) 10 questions with a scale of 1-4 (1 = no symptoms - 4 = severe symptoms), higher score = worst values.~Brief Psychiatric rating scale (BPRS)- 24 symptom constructs, each to be rated in a 7-point scale of severity ranging from 'not present' to 'extremely severe' no participants analysed - terminated study"|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated|||Units on a scale||Full Range|Mean
1227798|NCT00681668|Primary|The Change in the Hamilton Rating Scale for Depression (HAM-D)|HAM-D is a 17-21 item observer-rated scale to assess presence and severity of depressive states. 9 items are scored 0-4, whereas the further 8 are scored 0-2, as these represent variables which do not lend themselves to quantitative rating (0=absent; 1=doubtful or slislight; 2=clearly present). Higher scores indicate higer depressive state|Baseline Day 1 to final visit 28 weeks||||scores on a HAM-D scale||Full Range|Mean
1227799|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events|Listing of all adverse event or SAE´s to show the safety and tolerability.|4 month|No data were reported as no participants completed the study|||number of events|||Number
1227800|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Concomitant Medication|Listing of all concomitant medication to show the efficacy and safety.|4 month|No data were reported as no participants completed the study|||Name of concomitant medication|||Number
1227801|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Laboratory Tests|Measuring of: B-Haemoglobin (g/dl), B-Haematocrit(%), B-Erythrocyte count(pl), B-Leucocytes count (nl), B-Platelet count(nl), Complete blood count (nl), B-Leucocytes differential count (%), B-HbA1c(%), S-ALAT (U/l), S-ASAT (U/l), S-GGT (U/l), P-Glucose (fasting)(mh/dl), S-prolactin level (ng/ml), S-Pregnancy test (IU/l), Qualitative analysis of urine with Stix®,Urine pregnancy. Comparing results with standard values.|4 month|No data were reported as no participants completed the study|||depending on the Lab test (see above)||Full Range|Mean
1227802|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference|Measuring of weight and waist circumference in centimeter.|4 month|No data were reported as no participants completed the study|||centimeters||Standard Deviation|Mean
1227803|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication|Concomitant psychotropic drugs will be coded (ATC = Drug code) to allow a comparison of the number of drugs used per ATC class and per treatment visit. The drugs used will be listed by keeping their brand name for allowing to translate them into costs.|4 month|No data were reported as no participants completed the study|||Drugs||Standard Deviation|Mean
1227804|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities|The number of lost work days, lost school days or days without completing routine daily activities will be evaluated. With any number of lost workdays or lost school days or without completing routine daily activities, the costs will increase and the productivity will decrease.|4 month|No data were reported as no participants completed the study|||days||Standard Deviation|Mean
1227805|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization|Any hospitalisation days in inpatients units and emergency ward stays will be recorded. At each hospitalisation, the number of days will be computed and at each visit, the cumulative total number of days will be used to calculate total costs. As higher the number of hospitalisation days as higher the costs per patient.|4 month|No data were reported as no participants completed the study|||days||Standard Deviation|Mean
1227806|NCT00681629|Secondary|Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)|"The 'CSQ-8 is a brief, self-administered method to monitor the consumer's satisfaction with services in outpatient psychotherapy, showing high internal consistency. It is identified as a core subset of the general CSQ covering 8 Likert-type items with four response choices where '1' indicates the lowest and '4' the highest degree of satisfaction."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227807|NCT00681629|Secondary|Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)|The 'Medication Adherence Rating Scale' (MARS) is a reliable and valid self-reporting tool for investigation of the compliance in psychiatric patients also recognizing the complexity of compliance behaviour. 10 questions on medication attitude have to be answered by 'yes' or 'no' (8 times 1= no and Yes = 0 and twice 1= no, Yes =1). Results will be descriptively summarized. Summarized results minimum 0: low medication adherence, maximum 10: high medication adherence.|4 month|No data were reported as no participants completed the study|||Participants|||Number
1227808|NCT00681629|Secondary|Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)|"The 'SES is a 14-item measure consisting of statements that assess the client specific engagement with services. It will be rated on a four-point Likert scale (not at all / rarely / sometimes / most of the time) by the investigator. The total score ranges from min. 0 to a max. of 42. Higher scores indicate lower engagement."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227809|NCT00681629|Secondary|Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale|"The '(RSM is a new 36-item measure validated to assess the QoL in different dimensions of schizophrenic patient treated with antipsychotics. It will be rated on a four-point Likert scale (not / rather not / rather yes / yes) by the patient and the investigator. The total score ranges from min. 0 to max. of 108. Higher scores indicate higher QoL."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227810|NCT00681629|Secondary|Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire|Q-LES-Q-18 will allow to generate a general QoL-index which will be used for the analysis and is defined as the average of the single scores for all 18 items. Scoring will be carried out from 1-5 per item (never / rarely / sometimes / frequently / all the time). Results will be descriptively summarized.|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227811|NCT00681629|Secondary|"Vocational Occupational Index VOC Score"|The “VOC” index will assess the following 7 items: 1 fulltime gainful employment, 2 homemaker or student, 3 part-time gainful employment (20 hours per week or less), 4 retired, 5 full or part-time volunteer, 6 on medical or psychiatric leave of absence, 7 unemployed, whether or not expected to work. Results will be descriptively summarized. The VOC index will be completed at each visit. Difference from baseline of the index will be derived at each assessment|Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227812|NCT00681629|Secondary|EQ-5D (European Quality of Life Questionnaire) Score|"The EQ-5D questionnaire is a generic measure of health status. It defines health in terms of five dimensions:1 (Mobility); 2 (Self-care); 3 (Usual activity); 4 (Pain/Discomfort); 5 (Anxiety/Depression).~The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Each dimension has 3 levels of severity- no problems, some problems and extreme problems. Higher scores indicate more problems."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227813|NCT00681629|Secondary|PSP (Personal and Social Performance) Scale Score|"The '(PSP rating scale (100 until 0) used by clinicians for assessment of 4 main domains of functioning in adult patients acc. (a) socially useful activities including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. Higher scores indicate better patient condition and performance."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227814|NCT00681629|Secondary|GAF (Global Assessment of Functioning) Scale Score|"The GAF is a numeric rating scale used by clinicians for assessment of the social, occupational, psychological functioning of adult patients. The scale represents a hypothetical continuum of mental health illness providing a descending scoring code from 100 until 0. Higher scores indicate better patient condition and performance."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227815|NCT00681629|Secondary|Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score|The schizophrenic symptomatology will be measured by the Positive and Negative Syndrome Scale (PANSS) providing 8 items of which each is rated on a severity scale ranging from 1-7, (1= absent - 7 = extreme severe. higher scores implying higher severity.|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227816|NCT00681629|Secondary|Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale|With the CGI-S the rate of the severity of a patient’s symptoms (positive, negative, cognitive, depressive and overall) using a scale ranging from 1 (normal, not ill) to 7 (among the most severely ill) is measured - higher scores implying higher severity.|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227817|NCT00681629|Secondary|Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score|The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227818|NCT00681629|Primary|Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale|The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.|4 months|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
1227819|NCT00681590|Secondary|Change From Baseline in Serum 25-hydroxyvitamin D Levels||baseline and 6 months||||ng/ml||Standard Deviation|Mean
1227820|NCT00681590|Primary|Number of Participants Who Develop Hypercalcemia|calcium serum levels measured at baseline and at the end of the intervention (6-months)|6 months||||participants|||Number
1227821|NCT00681564|Secondary|Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
1227822|NCT00681564|Secondary|Matrix Metalloproteinase-9 (MMP-9)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
1227823|NCT00681564|Secondary|Myeloperoxidase (MPO)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
1227824|NCT00681564|Secondary|Vascular Cell Adhesion Molecule 1 (VCAM-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
1227825|NCT00681564|Secondary|Intercellular Adhesion Molecule 1 (ICAM-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
1228082|NCT00679354|Secondary|Time to Tumor Progression (TTP)|The distribution of TTP will be analyzed separately using product limit (PL) estimate.|Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years|29 eligible patients are included in the analysis.|||Days||Inter-Quartile Range|Median
1227826|NCT00681564|Secondary|Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)|"Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®).~Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis."|12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
1227827|NCT00681564|Secondary|LDL Cholesterol||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy||||mg/dL||Standard Deviation|Mean
1227828|NCT00681564|Secondary|Subgingival Microbiota|Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf).|12 weeks post-periodontal therapy||||participants|||Number
1227829|NCT00681564|Secondary|White Blood Cell Count||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy||||cells/mm^3||Standard Deviation|Mean
1227830|NCT00681564|Secondary|Total Cholesterol||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy||||mg/dL||Standard Deviation|Mean
1227831|NCT00681564|Secondary|High-sensitivity C-Reactive Protein|The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).|Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy||||mg/L||Standard Deviation|Mean
1227832|NCT00681564|Primary|Brachial Artery Flow-mediated Dilation|All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).|Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables.|||Percentage of dilatation of brachial art||Standard Deviation|Mean
1227833|NCT00681538|Secondary|Mood Assessment: Change in Beck Depression Inventory - II (BDI-II)From Baseline to End of Treatment (Phase B)|This was a 21-question multiple choice self-report inventory. Subjects’ responses to the 21 questions were assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. An decrease in score indicates an improvement in condition.|Baseline (End of week 4) - end of treatment (end of week 17)||||Score on scale||Standard Deviation|Mean
1227834|NCT00681538|Secondary|Change EuroQoL Quality of Life Questionnaire (EQ-5D)From Baseline to End of Treatment (Phase B)|"The EQ-5D questionnaire provided two outcomes:~A weighted health state index visual analogue scale (VAS)~A self-rated health status VAS EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.~The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing."|[Baseline (End of Week 4) - End of treatment (End of Week 17)|EQ-5D Health State Index Sativex n=117 and placebo n=111. EQ-5D Health Status VAS Sativex n=121 and placebo n=117.|||score on scale||Standard Deviation|Mean
1227835|NCT00681538|Secondary|Physician Global Impressions of Change at End of Treatment (Phase B).||End of treatment (week 17)||||participants|||Number
1227836|NCT00681538|Secondary|Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).||End of treatment (week 17)|Sample sizes were reduced as not all subjects had a Carer to make this assessment.|||participants|||Number
1227837|NCT00681538|Secondary|Carer Global Impressions of Change at of Treatment (Phase B).||End of treatment (Week 17)|Sample sizes were reduced as not all subjects had a Carer to make this assessment.|||participants|||Number
1227838|NCT00681538|Secondary|Subject Global Impressions of Change at End of Treatment (Phase B).||End of Treatment (WeeK 17)||||participants|||Number
1227839|NCT00681538|Secondary|Change in Timed 10-metre Walk From Baseline to End of Treatment (Phase B).|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.|Baseline (End of Week 4) - End of treatment (End of Week 17)|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk.|||Seconds||Standard Deviation|Mean
1227840|NCT00681538|Secondary|Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs.|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. Leg - 3 movements were ankle dorsiflexion, knee extension and hip flexion. The total arm and leg score was the addition of the score for the 3 arm movements and 3 leg movements, respectively. One point was then added to each limb score to give a maximum score of 100; minimum was 1 point. Where both arms (or both legs) were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition.|Baseline (End of Week 4) - End of treatment (End of Week 17)|For Arm subject numbers were 23 for Sativex and 22 for placebo. For Leg subject numbers were 91 for Sativex and 92 for placebo.|||Score on scale||Standard Deviation|Mean
1227841|NCT00681538|Secondary|Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B).|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Baseline (End of Week 4) - End of treatment (End of Week 17)||||Score on scale||Standard Deviation|Mean
1228736|NCT00674154|Secondary|Improved Muscular Function||One Year|||||||
1227842|NCT00681538|Secondary|Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B).|The sleep disruption NRS score was recorded by subjects via a daily call to the interactive voice response system at bedtime. Subjects were asked “On a scale of ‘0 to 10’ please indicate how you your spasticity disrupted your sleep last night” with the anchors: 0 = ‘did not disrupt sleep’ and 10 = ‘completely disrupted (unable to sleep at all)'.|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)||||Points on scale||Standard Deviation|Mean
1227843|NCT00681538|Secondary|Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B).|The subjects’ baseline spasm frequency was the mean of the last seven days scores (Week 4) of Phase A treatment. The variable for analysis was the change in mean spasm frequency from baseline to the end of treatment (last 7 days of Week 17 Phase B).|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)||||Spasms per day||Standard Deviation|Mean
1227844|NCT00681538|Secondary|Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline.|A subject was classified as a responder in the evaluable period provided they did not withdraw due to lack of efficacy and achieved at least a 30% or 50% reduction (i.e. improvement) in the mean NRS spasticity score from baseline (Day 1) to the end of treatment(last 7 days of Week 17 Phase B). All other subjects and subjects without evaluable data were considered non-responders.|Baseline (Day 1) - End of treatment (last 7 days of Week 17)||||participants|||Number
1227845|NCT00681538|Primary|The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).|Subjects were asked “On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’. They were asked to relate ‘no spasticity’ to the time prior to the onset of their spasticity.|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)||||Points on scale||Standard Deviation|Mean
1227846|NCT00681473|Secondary|Percentage of Participants With Overall Survival|Percentages were estimated by Kaplan Meier|At 1, 3, and 5 years||||% of participants|||Number
1227847|NCT00681473|Secondary|Percentage of Participants With Progression Free Survival|Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier|At 1, 3, and 5 years||||% of participants|||Number
1227848|NCT00681473|Primary|Number of Participants With Late Effects > 3 Months Post RT||5 years||||Participants|||Count of Participants
1227849|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 24 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 24 Months|Of the 88 participants in Arm 1 who started the study, 75 completed the Activities Assessment Scale at 24 months. Of the 84 participants in Arm 2 who started the study, 57 completed the Activities Assessment Scale at 24 months.|||units on a scale||Standard Deviation|Mean
1227850|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 12 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 12 Months|Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 12 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 12 months.|||units on a scale||Standard Deviation|Mean
1227851|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 6 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 6 Months|Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 6 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 6 months.|||units on a scale||Standard Deviation|Mean
1227863|NCT00681187|Secondary|Number of Patients Stating at Least One Injection Interfered With Daily Activities|The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'|Between baseline to week 32, after each injection (8-9 injections)|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded|||Participants|||Number
1228120|NCT00679172|Primary|Number and Proportion of Subjects Experiencing Symptomatic Fever.|Number and proportion of subjects experiencing symptomatic (e.g., chills, rigors, sweating, headache, myalgia etc.) elevated body temperature of 38.0°C or more in the 14 days following dosing.|From start of dosing to 14 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||Participants|||Count of Participants
1227852|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 3 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty = 1” to “Not able to do it = 5.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 3 Months|Of the 88 participants in Arm 1 who started the study, 81 completed the Activities Assessment Scale at 3 months. Of the 84 participants in Arm 2 who started the study, 77 completed the Activities Assessment Scale at 3 months.|||units on a scale||Standard Deviation|Mean
1227853|NCT00681265|Secondary|Fluorescein Tear Film Break-up Time|Standard clinical assessment methodology for assessing tear stability.|120 minutes after eye drops instillation|Study N determined empirically by PI.|||seconds||Standard Deviation|Mean
1227854|NCT00681265|Primary|Noninvasive Tear Film Break-up Time|State-of-the-art methodology to assess tear stability.|15 minutes after eye drop instillation|Study N determined empirically by PI.|||seconds||Standard Deviation|Mean
1227855|NCT00681187|Secondary|Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method|"Assessed by the number of HCP with a positive response 'yes' to two questions:~Based on your experience during this trial, did you feel confident in the safety of your patients?~Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?"|Between week 30 to 34|One HCP from each site who enrolled participants replied to the question|||participants|||Number
1227856|NCT00681187|Secondary|5-hydroxyindoleacetic Acid (5-HIAA) Levels|"Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site.~'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.~'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.~'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.~'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2."|Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.|5-HIAA were assessed as judged necessary by the investigator at each site.|||nmol/l||Standard Deviation|Mean
1227857|NCT00681187|Secondary|Chromogranin A Levels|"Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects.~'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.~'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.~'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.~'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2."|Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.|ITT population that had hormone levels assessed at each administration block.|||nmol/l||Standard Deviation|Mean
1227858|NCT00681187|Secondary|Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea|Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.|Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.|||participants|||Number
1227859|NCT00681187|Secondary|Perceived Symptom Control Evaluation in Respect to Episodes of Flushing|Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.|Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.|||participants|||Number
1227860|NCT00681187|Secondary|Total Number of Visits to HCP Due to Carcinoid Symptoms|Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.|Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)|Safety population: all randomised subjects with at least one dose of study medication|||visits|||Number
1227861|NCT00681187|Secondary|Days Sick Leave|Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).|Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)|Safety population: all randomised subjects with at least one dose of study medication. Two of the six subjects reported sick leave during the study. One subject was absent for one day due to unknown reason, the other was absent for 22 days due to surgery of metastasis.|||days|||Number
1227862|NCT00681187|Secondary|Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing|The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'|Between baseline to week 32, after each injection (8-9 injections)|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded|||participants|||Number
1227864|NCT00681187|Primary|Subject Preference for Self or Partner Administration|A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection|Between week 30 to 34|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded|||participants|||Number
1227865|NCT00681109|Primary|Ocular Surface Disease Index (OSDI)|"The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4].~Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning.~OSDI was assessed on the Baseline Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Baseline to Week 12."|Baseline and 12 Week Time Point data|The OSDI analysis for this study is based on a standard intention-to-treat analysis with each study participant analyzed with respect to the randomized treatment assignment, regardless of eventual compliance.|||units on a scale||Standard Deviation|Mean
1227866|NCT00681109|Primary|Corneal Fluorescein Staining Score|Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.|12 Week Time Point||||Units on a scale||Standard Deviation|Mean
1227867|NCT00681109|Primary|Tear Breakup Time (TBUT)|TBUT measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.|12 Week Time Point||||Seconds||Standard Deviation|Mean
1227868|NCT00681109|Primary|Meibomian Gland Secretion Quality|Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)|12 Week Time Point||||Units on a scale||Standard Deviation|Mean
1227869|NCT00681044|Secondary|Tolerability||100 days|No data were collected or analyzed due to study termination||||||
1227870|NCT00681044|Secondary|Overall Survival||life|No data were collected or analyzed due to study termination||||||
1227871|NCT00681044|Secondary|Organ or Clinical Response||One year|No data were collected or analyzed due to study termination||||||
1227872|NCT00681044|Secondary|Predictability of Early Free Light-chain Response for Heme Response||One month|No data were collected or analyzed due to study termination||||||
1227873|NCT00681044|Primary|Hematologic Response Rate||one year|No data were collected or analyzed due to study termination||||||
1227874|NCT00681031|Primary|Geometric Mean Titre (GMT) of Varicella Antibodies|Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).|Predose (Day 0) and Day 28-35 Post Dose|All vaccinated participants excluding those with any protocol deviation which may have interfered with the immunogenicity evaluation and excluding participants with herpes zoster onset before the post-vaccination blood sample|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1227875|NCT00680992|Secondary|Mean Serum Denosumab Trough Concentrations|Blood samples for determination of serum denosumab concentration levels were obtained from participants included in the pharmacokinetic (PK) substudy at baseline (prior to administration of study drug on day 1) and at scheduled time points during the study up to week 25.|Blood samples were collected at baseline (day 1), days 8 and 15 and weeks 5, 9, 13 and 25.|The PK analysis set included all participants who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement. Only participants with available data at each time point were included in the analysis.|||nanograms / milliliter||Standard Deviation|Mean
1227876|NCT00680992|Secondary|Percentage of Participants Without Any On-Study Surgery at Month 6 for Cohort 2|The percentage of participants without any surgery at month 6 was equivalent to the number of participants without any surgery by month 6 divided by the number of cohort 2 participants who had an opportunity to complete 6 months of treatment, expressed as a percentage.|At month 6.|The efficacy analysis set included all enrolled participants who were eligible for the study, and who received at least one dose of denosumab on the study. Analysis was performed on cohort 2 only for those who had the opportunity to be on-study for at least 6 months.|||Percentage of participants||95% Confidence Interval|Number
1227877|NCT00680992|Secondary|Time to Disease Progression or Recurrence During the On-Study Period for Cohort 1, Presented as Kaplan-Meier Estimates of Probability|Time to disease progression or recurrence during the on-study period was defined as the time interval (in days) from the date of first dose of study drug to the date of earliest Progressive Disease (PD) during the initial treatment phase. PD was defined as the response of progressive disease, locally recurrent disease or relapse as captured in the Disease Status page of the Case Report Form. If a participant had not had PD by the end of the initial treatment phase date, time to disease progression or recurrence were censored at her/his end of initial treatment phase date. Since median time to disease progression or recurrence for participants in cohort 1 was not reached, Kaplan-Meier estimates for the probability (expressed as a percentage) of participants in cohort 1 to have disease progression or recurrence at months 6, 12, 24, 36 and 60 are presented.|From first dose of study drug up to the end of the initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).|The efficacy analysis set included all enrolled participants who were eligible for the study, and who received at least one dose of denosumab on the study. Analysis was performed on cohort 1 only.|||Percent probability||95% Confidence Interval|Number
1227892|NCT00680914|Secondary|Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine|Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||ug/mL||95% Confidence Interval|Geometric Mean
1227878|NCT00680992|Primary|Number of Participants Who Experienced the Maximum Toxicity Grade (CTCAE Grade ≥ 3) in the Indicated Clinical Chemistry Parameters|Serum samples for clinical chemistry were collected on study day 1 (baseline), day 15, week 5 and each study visit Q4W thereafter until last study visit for the on-study period (ie, until end of initial treatment phase). The parameters included albumin, calcium (albumin-adjusted), creatinine, magnesium and phosphate. Results are presented for number of participants who experienced the maximum toxicity grade for each of these clinical parameters. The maximum toxicity grade experienced by each participant was based on CTCAE, v3.0, and are summarized for Grade 3 and 4. Increases and decreases in relationship to the normal parameter ranges are indicated as 'Above' and 'Below' respectively.|Baseline (day 1) up to last study visit for initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).|The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.|||Participants|||Number
1227879|NCT00680992|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|AE defined as any untoward medical occurrence in a clinical trial participant. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v3.0) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. Investigator assessed AEs for relatedness to study drug. Results are presented for treatment-emergent events (TEAEs) and included all AEs occurring from first dose in initial treatment phase to end of initial treatment phase (or for participants entering retreatment, from first dose in initial treatment phase until end of retreatment phase).|From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months).|The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.|||Participants|||Number
1227880|NCT00680953|Secondary|Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.|The results are expressed as a percentage by Kaplan-Meier estimate.|Baseline to 24 Months||||percentage of participants|||Number
1227881|NCT00680953|Secondary|The Percentage of Non-vertebral Fractures|The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures|Baseline to 24 Months||||percentage of participants||95% Confidence Interval|Number
1227882|NCT00680953|Primary|Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo||Baseline to 24 months||||Vertebral fractures||95% Confidence Interval|Mean
1227883|NCT00680914|Secondary|Number of Subjects With Serious Adverse Events (SAE)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||subjects|||Number
1227884|NCT00680914|Secondary|Number of Subjects Reporting Unsolicited Adverse Events||Within 31 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||subjects|||Number
1227885|NCT00680914|Secondary|Number of Subjects With Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.~Fever was defined as axillary temperature >= 37.5 degrees Celsius."|Within 4 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||subjects|||Number
1227886|NCT00680914|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within 4 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||subjects|||Number
1227887|NCT00680914|Secondary|Number of Subjects With Seroprotection Status Against PRP|Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1227888|NCT00680914|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentration of anti-PRP antibody given as GMC in ug/mL.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||ug/mL||95% Confidence Interval|Geometric Mean
1227889|NCT00680914|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes|The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1227890|NCT00680914|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes|Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||ug/mL||95% Confidence Interval|Geometric Mean
1227891|NCT00680914|Secondary|Anti-PD Antibody Concentration|Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.|One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1228121|NCT00679172|Primary|Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.|Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||Participants|||Count of Participants
1227893|NCT00680914|Secondary|Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).~Pneumococcal cross-reactive serotypes were 6A and 19A."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1227894|NCT00680914|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value|"The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was >= 8.~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1227895|NCT00680914|Secondary|Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes|"Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL.~Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1227896|NCT00680914|Primary|Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|One month after administration of 3rd dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1227897|NCT00680901|Secondary|Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Hematology Parameters|Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for indicated hematology parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Hematology parameter included: Hemoglobin (Hemo), Total Neutrophils (TN) Absolute, Platelet Count (PC), and White Blood Cell (WBC) Count.|From Baseline (Day 1) until 28 days after the last dose (average of 239 days)|"Safety Population. Different participants may have been assessed for different parameters; thus the number of participants analyzed reflects everyone in the Safety Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
1227898|NCT00680901|Secondary|Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Clinical Chemistry Parameters|Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for the indicated clinical chemistry parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transeferase (AST), Total Bilirubin (TB), Calcium (Hypercalcemia and Hypocalcemia), Creatine Kinase (CK), Creatinine, Glucose (Hyperglycemia [high] and Hypoglycemia [low]), Potassium (Hyperkalemia [high] and Hypokalemia [low]), Magnesium (Hypermagnesemia [high] and Hypomagnesemia [low]), and Sodium (Hypernatremia [high] and Hyponatremia [low]).|From Baseline (Day 1) until 28 days after the last dose (average of 239 days)|"Safety Population. Different participants may have been assessed for different parameters; thus the number of participants analyzed reflects everyone in the Safety Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
1227899|NCT00680901|Secondary|Mean Change in Scores on the Questionnaire EuroQoL-5 Dimensions (EQ-5D) From Baseline to Week 36|The EQ-5D is a generic preference-based HROOL self administered tool comprising of a 5-dimensional health status measure (5D utility measure) and a visual analog rating scale feeling thermometer (T.). 5D utility measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. T. assesses participant’s current health state. Each 5D utility question was responded to on a 3-point scale, indicating the level of impairment (1=no problem; 2=some or moderate problem(s); 3=unable, or extreme problems). The index utility values corresponding to the 243 health states were defined by the EuroQol classification and calculated based on country-specific regression coefficients. In the UK-based value set, the possible EQ-5D index utility values range from –0.594 to 1. The T. value ranges from 0 to 100. EQ-5D utility index score 0=death, 1=perfect health, -0.594 = worse than death. The T. score: 100=best imaginable health state, 0=worse imaginable health state.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
1227900|NCT00680901|Secondary|Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36|The EORTC QLQ-STO22, the Gastric module of QLQ-C30, is a self administered tool use to assess HROOL of patients with gastric cancer. It consists of 22 items consisting of nine symptom scales or single items (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, taste, body image, hair loss) that were developed for participants with gastric cancer. For the symptom scales or single items, participants assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
1227925|NCT00680745|Secondary|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%|To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.|At Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1228122|NCT00679081|Secondary|Subject Preference Measures||6-months|||||||
1228123|NCT00679081|Secondary|Post-Surgical Subject Comfort Measures||4-weeks|||||||
1227901|NCT00680901|Secondary|Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36|The QLQ-C30, a self administered tool used to assess HROL, consists of 30 items that assesses 15 domains consisting of 5 functional scales (s.) (physical, role, emotional, cognitive, social) and nine symptom s. or single items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status or QOL s.. For the functional s. and symptom s. or single items, participants assessed using a 4-point s. (1=not at all; 2=a little; 3=quite a bit; 4=very much), whereas global health status or QOL was assessed using a 7-item Likert s., ranging from “poor” to “excellent.” All s. and single-item scores ranged from 0 to 100. For the functional scores, a higher score indicated a better HRQOL, i.e. 0=worst HRQOL, 100=best HRQOL; for the symptom s. or single items , a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
1227902|NCT00680901|Secondary|Number of Participants With Adverse Events of the Indicated Severity, Per the National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to NCI CTCAE, version 3.0: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the first dose of study medication until 30 days after the last dose (average of 229 days)|Safety Population|||Participants|||Number
1227903|NCT00680901|Secondary|Number of Participants With Any Non-serious Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication until 30 days after the last dose (average of 229 days)|Safety Population: all randomized participants who received at least one dose of study medication|||Participants|||Number
1227904|NCT00680901|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of a CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) until the first documented sign of PD or death due to any cause. Per RECIST, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause (average of 36 weeks)|Primary Efficacy Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.|||Months||95% Confidence Interval|Median
1227905|NCT00680901|Secondary|Time to Response (TTR)|TTR is defined as the time from randomization until the date of the first documented evidence of CR (the disappearance if all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking a reference the Baseline sum LD) as assessed by the investigator.|From Baseline (Day 1) until the first documented evidence of confirmed CR or PR (average of 9 weeks)|Primary Efficacy Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.|||Months||95% Confidence Interval|Median
1227906|NCT00680901|Secondary|Number of Participants With Clinical Benefit (CB)|CB is defined as evidence of a CR (disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started) as assessed by the investigator.|From randomization until disease progression (PD) or death due to any cause (average of 30 weeks)|Primary Efficacy Population|||Participants|||Number
1227907|NCT00680901|Secondary|Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR)|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target and non-target lesions) or a PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) as assessed by the investigator (confirmed by radiographic imaging within 4 weeks from initial observations).|From randomization until the date of the first documented response of CR or PR (average of 9 weeks)|Primary Efficacy Population|||Participants|||Number
1227926|NCT00680745|Secondary|Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise|To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
1227927|NCT00680745|Secondary|Adjusted Mean Change in Body Weight|To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
1227908|NCT00680901|Secondary|Progression Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >= 1 new lesion. Participants who did not have a radiological assessed PD but had symptomatic PD were also counted. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From randomization until the earliest date of disease progression or death due to any cause (average of 30 weeks)|Primary Efficacy Population|||months||95% Confidence Interval|Median
1227909|NCT00680901|Primary|Overall Survival in All Randomized Participants|Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.|From randomization until death due to any cause (average of 51 weeks)|Intent-to-Treat (ITT) Population: all participants randomized to study treatment, regardless of whether they actually received study medication.|||months||95% Confidence Interval|Median
1227910|NCT00680901|Primary|Overall Survival|Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.|From randomization until death due to any cause (average of 51 weeks)|Primary Efficacy Population: all randomized participants with Human Epidermal Growth Factor Receptor 2 (ErbB2)-positive tumors (based on Fluorescence In Situ Hybridization [FISH]-positive designated central laboratory assessment).|||months||95% Confidence Interval|Median
1227911|NCT00680862|Primary|Number of Participants Who Completed the Survey|survey responses from participants on thoughts pertaining to implementation of HIV rapid testing|6 months||||participants|||Number
1227912|NCT00680836|Secondary|Change in Bloating|Bloating is measured on a scale from 0 to 4; 0 = no bloating to 4 = severe bloating. Change in bloating is calculated from baseline to post treatment.|2 weeks||||units on a scale||95% Confidence Interval|Mean
1227913|NCT00680836|Secondary|Change in Abdominal Pain With Bowel Movement|Severity of abdominal pain on a scale of 0 to 4 was measured; 0 meaning no pain to 4 meaning severe pain. Change in abdominal pain from baseline to post treatment was calculated.|2 weeks||||units on a scale||95% Confidence Interval|Mean
1227914|NCT00680836|Secondary|Change in Bowel Urgency|Urgency in a bowel movements compared from baseline to post treatment was measured. Participants were asked to note if they had urgency at bowel movements (meaning if they had to rush to the restroom). They marked either 'yes' or 'no'. The percentage of the time they said yes was calculated for 7 days. The difference between baseline and post treatment urgency was calculated.|2 weeks||||difference in percentage of 'Yes'||95% Confidence Interval|Mean
1227915|NCT00680836|Secondary|Change in Stool Consistency|Change in Stool consistency from baseline to post treatment is measured. Bristol stool scale is used for this purpose. The scale ranges from a value of 1- 7; 1 being very hard stool to 7 being liquid stools. The change is measured for 1 week post-treatment and the average consistency is used for the purpose of measuring change from baseline.|2 weeks||||units on a scale (BSS)||95% Confidence Interval|Mean
1227916|NCT00680836|Secondary|Change in Stool Frequency (Number of Bowel Movements Per Day)|Change in stool frequency (number of bowel movements per day) compared from baseline to post treatment is measured. Number of bowel movements per day before treatment is subtracted from the number of bowel movements per day after treatment. The change in frequency has been reported in the outcomes table.|2 weeks||||Bowel movements/ day||95% Confidence Interval|Mean
1227917|NCT00680836|Primary|Global Improvement Scale|Improvement in Irritable Bowel Syndrome symptoms post treatment is measured. This scale is not measured at baseline. Participants are asked if their symptoms improved or got worse and to rate it on a scale of 1- 7 for seven days. Average score for 7 days is calculated. The Global improvement scale ranges from 1- 7. Score of 1-3 means the IBS symptoms got worse, 4 means no change and 5-7 means improvement in the IBS symptoms.|Measured for seven days at the end of 2 weeks treatment and average score is calculated||||units on a scale||Standard Deviation|Mean
1227918|NCT00680823|Secondary|Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study||72 hours||||Participants|||Count of Participants
1227919|NCT00680823|Secondary|Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision||3 hours||||Participants|||Count of Participants
1227920|NCT00680823|Primary|The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.||30 minutes||||Participants|||Count of Participants
1227921|NCT00680797|Primary|Insulin Sensitivity|As measured by change in insulin levels pre- and post-hormone changes|6 weeks|Two participants had missing values post-intervention therefore number of participants analyzed total 31.|||micro International Units/mL||Standard Deviation|Mean
1227922|NCT00680771|Primary|Positive Antibody Response|Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL.|3 Months after initial vaccination|From subjects with complete data only.|||participants|||Number
1227923|NCT00680745|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
1227924|NCT00680745|Secondary|Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2|To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with baseline BMI of 27 kg/m2 or more and Week 24 (LOCF) body weight value|||kg||95% Confidence Interval|Least Squares Mean
1228124|NCT00679081|Secondary|Aesthetic Measures||6-months|||||||
1228125|NCT00679081|Secondary|Periodontal Health Measures||6-months|||||||
1227928|NCT00680745|Primary|Adjusted Mean Change in HbA1c Levels|To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
1227929|NCT00680706|Primary|Effect of Thiamine Supplementation on Dyspnea|Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.|8-Hour||||mm||95% Confidence Interval|Mean
1227930|NCT00680706|Primary|Effect of Thiamine Supplementation on Dyspnea|Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.|Baseline||||mm||95% Confidence Interval|Mean
1227931|NCT00680628|Primary|Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome||90 days||||participants|||Number
1227932|NCT00680628|Primary|Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36)||90 days||||participants|||Number
1227933|NCT00680628|Primary|Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage||1,2,3,4, and 5 days||||participants|||Number
1227934|NCT00680524|Primary|Acceptability to Providers and Patients|Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below|Six months||||units on a scale||Standard Deviation|Mean
1227935|NCT00680459|Secondary|Recurrence of Central Venous Line Infection Within 35 Days of Enrollment||35 days||||# of pts with recurrent infection|||Number
1227936|NCT00680459|Secondary|Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study||35 days||||number of lines preserved|||Number
1227937|NCT00680459|Primary|Clearance of Central Venous Line Infection by Day 6 of Study||6 days||||number of CVL cleared|||Number
1227938|NCT00680407|Post-Hoc|Efficacy - Improvement by at Least 2 Points in Histology (NAS) - With NAS Without Cirrhosis|This outcome measure excludes the substantial percentage (62.8%) of patients with baseline biopsies that were deemed ineligible (per inclusion criteria) by the central pathologist due to NAS <4 or absence of NASH (nonalcoholic steatohepatitis) (n=34), NASH with presence of cirrhosis (n=1), or slides unavailable/not evaluable for reading (n=14).|48-50 week treatment period|Subgroup of ITT (Intent to Treat) Patients with NASH and without cirrhosis population|||participants|||Number
1227939|NCT00680407|Secondary|Safety - Occurrence of a Dose-limiting Toxicity||48-50 week treatment period||||participants|||Number
1227940|NCT00680407|Primary|Efficacy - Improvement by at Least 2 Points in Histology (NAS)||48-50 week treatment period||||participants|||Number
1227941|NCT00680368|Secondary|Intraclass Correlation Coefficient for Test-retest Reliability for Attending Physicians|Assesses the test-retest reliability among repeated responses to surveys administered to attending physicians only.|24 hours||||Intraclass Correlation Coefficient||95% Confidence Interval|Number
1227942|NCT00680368|Secondary|Intraclass Correlation Coefficient Assessing Test-retest Reliability for Resident Physicians|Assesses the test-retest reliability of repeated responses for resident physicians only to report the total time spent during resident supervision.|24 hours||||Intraclass Correlation Coefficient||95% Confidence Interval|Number
1227943|NCT00680368|Primary|Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.|Describes agreement between physician resident and attending physician assessment of total resident supervision time for a given patient and patient care clinical encounter.|24-hours||||Intraclass Correlation Coefficient||95% Confidence Interval|Number
1227944|NCT00680316|Secondary|Change in Respiratory Symptom Domain Score From the Cystic Fibrosis Questionnaire Revised (CFQ-R) for Parents of Preschoolers and for Preschoolers|"The CFQ-R for Preschoolers and the CFQ-R for Parents of Preschoolers was designed specifically to measure the impact of CF for patients with a diagnosis of CF. Each question is answered using a 4-point Likert scale.~In order to calculate the domain/symptom scale scores, the following algorithm is followed~Re-number items which have been reverse coded~Calculate the mean of the items to be included. If more than half of the items are missing, then the score is considered missing~Re-scale to result in a scaled score which ranges from 0 to 100, with higher scores indicating better health"|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.||||||
1227945|NCT00680316|Secondary|Change in Resistance at 4, 6, 8, and 10 Hz (Rrs4, Rrs6, Rrs8, and Rrs10)|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Resistance is complex measure that incorporates the lack of changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (10Hz was used for the secondary endpoint).|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.||||||
1227946|NCT00680316|Secondary|Change in Reactance at 4, 6, and 10 Hz (Xrs4, Xrs6, and Xrs10)|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (8Hz was used for the primary endpoint). Reactance is thought to reflect the elastic properties of the lung.|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.||||||
1227947|NCT00680316|Primary|Change in Reactance at 8 Hz (Xrs8) From Visit 2 to Visit 3 (Change From Baseline at Visit 2 to Visit 3, After Study Drug Treatment).|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (8Hz was used for the primary endpoint). Reactance is thought to reflect the elastic properties of the lung.|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.||||||
1227948|NCT00680225|Secondary|Visual Acuity Changes||12 mo|PI has left the institution and summary data are not available.||||||
1227949|NCT00680225|Primary|Mean Tumor Thickness||12 mo||||mm||Full Range|Mean
1227950|NCT00680186|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|From first intake of study drug to last intake of study drug + 6 days washout|TS|||participants|||Number
1227951|NCT00680186|Secondary|Number of Participants With Acute Coronary Syndrome (ACS)|Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.|From first intake of study drug to last contact date|TS|||participants|||Number
1227952|NCT00680186|Secondary|Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events|"Major bleeding events (MBE) are defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) are defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|From first intake of study drug to last intake of study drug + 6 days washout|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.|||participants|||Number
1227953|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE|Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
1227954|NCT00680186|Secondary|Number of Participants Who Died (Any Cause)|Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
1227955|NCT00680186|Secondary|Number of Participants Who Died Due to VTE|VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.|From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)|FAS|||participants|||Number
1227956|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic Non-fatal PE|Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
1227957|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic DVT|Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
1227958|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic VTE and All Deaths|VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
1227974|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76|AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from baseline was calculated as the Week 52or Week 76 value minus the baseline value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||millimoles per Liter (mmol/L)||Standard Error|Mean
1227959|NCT00680186|Primary|Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE|All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
1227960|NCT00680121|Secondary|Symptom Checklist-90 (SCL-90): Global Severity Index|The SCL-90 is a brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators. It provides an overview of symptom severity and intensity. The outcome measures psychiatric symptoms using a 30-item scale reported as t-scores relative to a normative population.|6 Months||||t-score||Standard Deviation|Mean
1227961|NCT00680121|Secondary|Barrett Impulsivity Scale: Total Impulsiveness|Scale measures impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). Items are scored on a 4 point scale with 1 point equaling rarely/never up to 4 points equaling almost always/always. Total impulsivity score ranges from 30 (least impulsive) to 120 (most impulsive). The higher the score the higher the level of impulsiveness.|6 Months||||scores on a scale||Standard Deviation|Mean
1227962|NCT00680121|Secondary|Alcoholism Severity Scale|The alcoholism severity scale measures the severity of a person's dependence to alcohol. The scale ranges from a score of 0 (least severe) to 33 (most severe). The higher the score the worse the dependence.|6 Months||||scores on a scale||Standard Deviation|Mean
1227963|NCT00680121|Primary|Change in Average Daily Alcohol Consumption|measured as standard drinks of alcohol per day (SD/day)|Change from Baseline to 6 Months||||alcoholic drinks per day||Standard Deviation|Mean
1227964|NCT00680056|Secondary|Mean Score on the Transitional Dyspnea Index (TDI)|TDI is a multidimensional clinical instrument developed to provide a comprehensive assessment of change in dyspnea after an intervention, considering three components (functional impairment, magnitude of task, and magnitude of effort). It ranges from -9 (major deterioration) to +9 (major improvement).|After 2 week of each treatment||||score on scale||Standard Deviation|Mean
1227965|NCT00680056|Primary|Percentage Change in Exercise Tolerance From Baseline at 2 Weeks|Percentage change from baseline in time to the limit of tolerance on a high intensity constant-speed treadmill exercise test (with a speed corresponding to 80% of that obtained during incremental test)|Baseline and after 2 weeks with each treatment|The specific period where the patient received a given treatment were analysed together.|||Percentage change||Standard Error|Mean
1227966|NCT00680043|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods|A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks.|Weeks 1 to 28|Full Analysis Population|||percentage of participants|||Number
1227967|NCT00680043|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods||Weeks 1 to 28|Full Analysis Population|||percentage of participants|||Number
1227968|NCT00680043|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.|Baseline and Weeks 21-28|Full Analysis Population|||g/dL||Standard Deviation|Mean
1227969|NCT00680017|Secondary|Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.|High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).|Baseline to 8 weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 postbaseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Least Squares Mean
1227970|NCT00680017|Primary|Median Percent Change in Triglycerides From Baseline to Week 8.|Triglycerides were measured in milligrams/deciliter.|Baseline to 8 weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 postbaseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Inter-Quartile Range|Median
1227971|NCT00679952|Secondary|Severity of Pancreatic Fistulas||2 years|||||||
1227972|NCT00679952|Primary|Number of Patients With Pancreatic Fistula|"pancreatic fistula rate is stratified according to ISGPF criteria.~Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate"|postoperative 1 week||||participants|||Number
1227973|NCT00679939|Post-Hoc|Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76|AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from Week 52 was calculated as the Week 76 value minus the Week 52 value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||millimoles per Liter (mmol/L)||Standard Error|Mean
1227975|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
1227976|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227977|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
1227978|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (orWeek 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227979|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
1227980|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227981|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
1227982|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227983|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
1227984|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227985|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from Baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
1228126|NCT00679081|Primary|Overall Rate of Adverse Events (AEs)|"Adverse events were collected at every visit throughout the 6 month duration.~An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition."|6-month||||participants|||Number
1227986|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227987|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
1227988|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227989|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
1227990|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227991|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
1227992|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227993|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
1227994|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days(or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227995|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
1227996|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227997|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
1227998|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 daysor Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days(or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Baseline, Week 52 plus 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1227999|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
1228000|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228001|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
1228002|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228003|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
1228004|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228005|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-posterior is the upper and back section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
1228006|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228007|NCT00679939|Post-Hoc|Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228008|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228009|NCT00679939|Post-Hoc|Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228010|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228011|NCT00679939|Post-Hoc|Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228012|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228013|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228022|NCT00679939|Other Pre-specified|Percent Change in Percentage of Free Estradiol From Week 52 to Week 76|Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228014|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228015|NCT00679939|Post-Hoc|Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Week 52 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/ vBMD at Week 52 + 30 days x 100% and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228016|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days|Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Baseline was calculated as (vBMD at Week 52+30 days (or Week 76+30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228017|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228018|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (BMD at Week 52 + 30 days (orWeek 76 + 30 days) minus BMD at baseline)/BMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228019|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (BMD at Week 52 + 30 days (or Week 76 + 30 days) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for all of the DXA measurements.|||percent change||Standard Error|Mean
1228020|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 10 days or Week 76 + 10 days was calculated as (BMD at Week 52 + 10 days (or Week 76 + 10 days ) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 10 days, and Week 76 + 10 days|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 10 days after initiating OL MET or at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for the DXA lumbar spine measurement.|||percent change||Standard Error|Mean
1228021|NCT00679939|Other Pre-specified|Percent Change in Free Estradiol From Week 52 to Week 76|Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228023|NCT00679939|Secondary|Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76|SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228024|NCT00679939|Secondary|Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76|SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228025|NCT00679939|Secondary|Percent Change in Free Testosterone From Week 52 to Week 76|Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228026|NCT00679939|Secondary|Percent Change From Baseline in Free Testosterone at Week 52 and Week 76|Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228027|NCT00679939|Secondary|Percent Change in Total Testosterone From Week 52 to Week 76|Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228028|NCT00679939|Secondary|Percent Change From Baseline in Total Testosterone at Week 52 and Week 76|Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228029|NCT00679939|Secondary|Percent Change in Serum Estradiol From Week 52 to Week 76|Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228030|NCT00679939|Secondary|Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76|Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228031|NCT00679939|Secondary|Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76|Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228032|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76|Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228033|NCT00679939|Secondary|Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76|Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228034|NCT00679939|Secondary|Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76|Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228035|NCT00679939|Secondary|Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76|CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228036|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76|CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228037|NCT00679939|Secondary|Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76|BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. One participant did not have P1NP measured.|||percent change|||Number
1228038|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76|BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
1228039|NCT00679939|Secondary|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET and Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for all of the DXA measurements.|||percent change||Standard Error|Mean
1228040|NCT00679939|Secondary|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 10 days and Week 76 + 10 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.|||percent change||Standard Error|Mean
1228041|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline and Week 52|Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.|||percent change||Standard Error|Mean
1228042|NCT00679939|Primary|Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52+10 days and Week 76+10 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228043|NCT00679939|Primary|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline and Week 76+10 days|Safety Population. Only evaluable participants with a value at baseline and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
1228057|NCT00679627|Secondary|Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)|The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants “home with friend or relative” using the APAS-CarB.|Baseline, Months 12 and 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline APAS-CarB measure.|||Percentage of participants|||Number
1228331|NCT00677820|Secondary|Number of Subjects Reporting Any Adverse Event (AE) Post-treatment||Days 0-7|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
1228044|NCT00679939|Primary|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm.|Baseline and Week 52|Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET are included in this primary analysis.|||percent change||Standard Error|Mean
1228045|NCT00679913|Secondary|Morbidity|Number of participants with morbidity, such as bleeding, sepsis, pancreatic fistula, intra-abdominal abscess, wound infection, delayed gastric emptying, and diarrhea after standard and extended pancreaticoduodenectomy|within 2 years after surgery||||participants|||Number
1228046|NCT00679913|Primary|Survival|comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery|2 year after surgery||||participants|||Number
1228047|NCT00679783|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.|RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.||||Days||Full Range|Median
1228048|NCT00679783|Secondary|CA-125 Levels (Ovarian Cancer Patients Only)|A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.|24 weeks||||Percentage of participants||95% Confidence Interval|Number
1228049|NCT00679783|Secondary|Best Percentage Change From Baseline in Tumour Size|The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).|Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.||||Percentage||Full Range|Median
1228050|NCT00679783|Secondary|Duration of Response|Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.|RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.||||Days||Full Range|Median
1228051|NCT00679783|Secondary|Disease Control Rate (DCR)|Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)|16 Weeks||||Percentage of participants||95% Confidence Interval|Number
1228052|NCT00679783|Primary|Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines|Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.|Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.||||Percentage of participants||95% Confidence Interval|Number
1228053|NCT00679627|Secondary|Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)|The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.|Baseline, Month 24|This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure.|||Scores on scale||Standard Deviation|Mean
1228054|NCT00679627|Secondary|Change From Baseline in the Mini–Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)|The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation [each with a maximum score of 5] was used). A higher score compared with baseline indicates less impairment.|Baseline, Month 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.|||Scores on scale||Standard Deviation|Mean
1228055|NCT00679627|Secondary|Change From Baseline in Institutional Status|This table describes the number of participants who were reported as institutionalized at baseline and Month 24.|Baseline, Month 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.|||Number of Participants|||Number
1228056|NCT00679627|Secondary|Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)|The table below presents the number of days that caregiving activities were provided during the past week.|Baseline, Months 12 and 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.|||Days||Standard Deviation|Mean
1228068|NCT00679367|Secondary|Number of Participants Removed From Study Due to Toxicities|Number of study participants removed from study treatment due to toxicities|One year|All patients who have had at least one dose of drug.|||Participants|||Count of Participants
1228058|NCT00679627|Secondary|Change From Baseline in Disability Assessment in Dementia (DAD) Scores|The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.|Baseline, Month 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline DAD measure.|||Scores on scale||Standard Deviation|Mean
1228059|NCT00679627|Secondary|Change From Baseline in the Mini–Mental State Examination (MMSE) Score|The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients’ cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.|Baseline, Month 6|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.|||Scores on scale||Standard Deviation|Mean
1228060|NCT00679627|Primary|The Number of Deaths Reported in Participants|An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.|Up to 2 years|The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug.|||Number of Participants|||Number
1228061|NCT00679627|Primary|Change From Baseline in the Mini–Mental State Examination (MMSE) Score|The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients’ cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.|Baseline, Month 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.|||Scores on scale||Standard Deviation|Mean
1228062|NCT00679432|Secondary|Endoscopic Improvement|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.~As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted."|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).|||percentage of patients||95% Confidence Interval|Number
1228063|NCT00679432|Secondary|Clinical Improvement.|Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).|||percentage of patients||95% Confidence Interval|Number
1228064|NCT00679432|Primary|Clinical and Endoscopic Remission.|Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).|||percentage of patients||95% Confidence Interval|Number
1228065|NCT00679380|Secondary|Endoscopic Improvement.|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.~As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted."|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.|||percentage of patients||95% Confidence Interval|Number
1228066|NCT00679380|Secondary|Clinical Improvement.|Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.|||percentage of patients||95% Confidence Interval|Number
1228067|NCT00679380|Primary|Clinical and Endoscopic Remission.|Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.|||percentage of patients||95% Confidence Interval|Number
1228737|NCT00674154|Primary|Decrease in Preoperative P-PTH|Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.|25 weeks||||pmol/l||Standard Error|Mean
1228069|NCT00679367|Secondary|Number of Organs Improved or Stable Based on Description Below:|"Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency.~Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline.~Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class.~Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus.~Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid.~Peripheral nervous system response – resolution of clinical signs of peripheral neuropathy."|one year||||number of organs stable or improved|involved organs||Number
1228070|NCT00679367|Primary|Number of Participants With Hematologic Response|"Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.~Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more."|one year|Participants who completed at least 3 cycles of treatment|||participants|||Number
1228071|NCT00679354|Secondary|Pharmacogenetic Polymorphism in Drug Transporter Gene ABCG2 and Relate to Cilengitide Disposition as Measured by Systemic Clearance|Cilengitide systemic exposure as measured by systemic clearance is used in this genotype-phenotype analysis. The ABCG2 (breast cancer resistance protein; BCRP) Exon 5 genotype is coded as 0/1/2 based on the number of G alleles.|At baseline|The analysis includes 12 eligible patients with both systemic clearance data and ABCG2 Exon 5 data available.|||Spearman’s Correlation|||Number
1228072|NCT00679354|Secondary|Pharmacogenetic Polymorphism in Drug Transporter Gene ABCG2 and Relate to Cilengitide Disposition as Measured by AUC|Cilengitide systemic exposure as measured by AUC is used in this genotype-phenotype analysis. The ABCG2 (breast cancer resistance protein; BCRP) Exon 5 genotype is coded as 0/1/2 based on the number of G alleles.|At baseline|The analysis includes 12 eligible patients with both AUC data and ABCG2 Exon 5 data available.|||Spearman’s Correlation|||Number
1228073|NCT00679354|Secondary|Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by Systemic Clearance|Cilengitide systemic exposure as measured by systemic clearance is used in this genotype-phenotype analysis. The ABCB1 (P-glycoprotein; P-gp) Exon 26 genotype is coded as 0/1/2 based on the number of T alleles.|At Baseline|The analysis includes 12 eligible patients with both systemic clearance data and ABCB1 Exon 26 data available.|||Spearman's Correlation|||Number
1228074|NCT00679354|Secondary|Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by AUC|Cilengitide systemic exposure as measured by AUC is used in this genotype-phenotype analysis. The ABCB1 (P-glycoprotein; P-gp) Exon 26 genotype is coded as 0/1/2 based on the number of T alleles.|At baseline|The analysis includes 12 eligible patients with both AUC data and ABCB1 Exon 26 data available.|||Spearman's correlation|||Number
1228075|NCT00679354|Secondary|Pharmacokinetic Parameter of Cilengitide in Plasma: Systemic Clearance (Cl)|Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Cl value per patient.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide|All 18 patients consenting for pharmacokinetic study are included in this analysis.|||L/hr/m^2||Full Range|Median
1228076|NCT00679354|Secondary|Pharmacokinetic Parameter of Cilengitide in Plasma: Half-life (t1/2)|Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one t1/2 value per patient.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide|All 18 patients consenting for pharmacokinetic study are included in this analysis.|||hours||Full Range|Median
1228077|NCT00679354|Secondary|Pharmacokinetic Parameter of Cilengitide in Plasma: Elimination Rate Constant (Ke)|Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Ke value per patient.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide|All 18 patients consenting for pharmacokinetic study are included in this analysis.|||hr^(-1)||Full Range|Median
1228078|NCT00679354|Secondary|Pharmacokinetic Parameter of Cilengitide in Plasma: Volume of Central Compartment (Vc)|Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Vc value per patient.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide|All 18 patients consenting for pharmacokinetic study are included in this analysis.|||L/m^2||Full Range|Median
1228079|NCT00679354|Secondary|Rate of Toxicity, Especially That of Symptomatic Intratumoral Hemorrhage (ITH) Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Rate of individual toxicity including that of symptomatic ITH will be summarized in each course of treatment using standard descriptive statistical methods.|Up to 5 years|Twenty-nine eligible patients are included in the analysis. One patient was excluded due to ineligibility.|||percent of pts with symptomatic ITH|||Number
1228080|NCT00679354|Secondary|Time to Death (TTD)|The distribution of TTD will be analyzed separately using PL estimate.|Time from study enrollment to death from any cause, assessed up to 5 years|Twenty-nine eligible patients are included in the analysis.|||Days||Inter-Quartile Range|Median
1228081|NCT00679354|Secondary|Time to Treatment Failure (TTF)|The distribution of TTF will be analyzed separately using PL estimate.|Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 5 years|Twenty-nine eligible patients are included in the analysis.|||Days||Inter-Quartile Range|Median
1228083|NCT00679354|Primary|Objective Response to Cilengitide|Objective response is defined as a complete response or partial response at 4 weeks that is sustained for at least another 4 weeks, or a stable disease at 4 weeks that is sustained for at least 12 weeks while on stable or decreasing dose of corticosteroids, except when corticosteroids are being used to control hydrocephaly unrelated to tumor progression.|Up to 16 weeks|Six patients are considered inevaluable for objective response (including one ineligible patient) and excluded from analysis.|||participants|||Number
1228084|NCT00679341|Secondary|Plasma Concentration of Free Emtansine|Plasma samples were collected from all 67 patients in the trastuzumab emtansine group 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. The plasma samples were assayed for free emtansine in a mass-spectrometric assay.|Baseline through Cycle 5 (up to 4 months)|Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.|||ng/mL||Standard Deviation|Mean
1228085|NCT00679341|Secondary|Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab|Serum samples were collected from all 67 patients enrolled in the trastuzumab emtansine arm using sparse pharmacokinetic sampling. Blood samples were collected prior to dosing and 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. Serum samples were assayed for trastuzumab emtansine and total trastuzumab (sum of unconjugated trastuzumab and emtansine conjugated to trastuzumab) in indirect sandwich ELISAs. The area under the concentration-time curve (AUC) was estimated based on non-compartmental analysis using WinNonlin (Version 5.2.1) software.|Baseline through Cycle 5 (up to 4 months)|Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.|||day•μg/mL||Standard Deviation|Mean
1228086|NCT00679341|Secondary|Time to Symptom Progression|Time to symptom progression was defined as the time from randomization to the first documentation of a ≥ 5-point decrease from baseline in the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) subscale score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B questionnaire is a valid and reliable measure of symptoms associated with breast cancer. The TOI-PFB is a 24-item subscale generated using 3 subsections (Physical Well-Being [7 items], Functional Well-Being [7 items], and Additional Concerns [10 items]) from the FACT-B questionnaire. Patients responded to each item on a scale of 0-4 (Not at all-Very much). The total score ranged from 0 to 96. A higher score indicates fewer symptoms. A positive change score indicates improvement.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with a Baseline and at least 1 post-Baseline valid score.|||Months||95% Confidence Interval|Median
1228087|NCT00679341|Secondary|Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|CB was defined as an objective response (complete response [CR], partial response [PR]) or stable disease (SD) for 6 months after randomization. For target lesions (TL), CR=the disappearance of all TL; PR=at least a 30% decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of TL, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions. For non-TL, CR=the disappearance of all non-TL; PR=the persistence of 1 or more non-TL; SD=the persistence of 1 or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits; PD=the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TL.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measurable disease at Baseline.|||Percentage of patients||90% Confidence Interval|Number
1228088|NCT00679341|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from initial response to investigator-assessed radiographic or clinical disease progression or death on study from any cause. For target lesions, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, disease progression was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measureable disease at Baseline. Only patients with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
1228089|NCT00679341|Secondary|Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measureable disease at Baseline.|||Percentage of patients||90% Confidence Interval|Number
1228090|NCT00679341|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death from any cause. Patients who were alive at the time of analysis were censored at the date on which they were last known to be alive. Patients with no post-baseline were censored at the date of randomization plus 1 day.|Baseline through the data cut-off date of 31 Aug 2011 (up to 2 years, 11 months)|Intent-to-treat population: All randomized patients.|||Months||95% Confidence Interval|Median
1228173|NCT00678639|Secondary|Number of Participants Who Utilized the Indicated Health Care Procedures|Measured as self report, assessed during telephone follow-up.|30d, 3mo, 6mo, and 1 year|Data reported through 30 days. Follow-up with participants is ongoing. Results will be updated once follow-up is complete.|||Participants|||Number
1228091|NCT00679341|Primary|Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)|PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|Intent-to-treat population: All randomized patients.|||Months||95% Confidence Interval|Median
1228092|NCT00679302|Secondary|New Lesion Development and Spread of Skin Abscesses (on Subject)|The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.|10-14 days and 3 month||||participants|||Number
1228093|NCT00679302|Primary|Skin Abscess Resolution||10-14 days||||participants||95% Confidence Interval|Number
1228094|NCT00679289|Secondary|Maximum KW2871 Antibody Levels in Plasma Following the First Infusion|Blood samples for pharmacokinetic (PK) measurements were collected at baseline and before and 30 minutes after the initial KW2871 infusion on Day 3. The KW2871 antibody protein in patient serum was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantitation was determined to be 100 ng/mL.|At Baseline and Study Day 3|Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and had at least 1 plasma sample evaluated for KW2871 antibody levels.|||µg/mL||Standard Deviation|Mean
1228095|NCT00679289|Secondary|Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871|Blood samples were collected for the analysis of HACA at baseline, on Days 29, 115, 143, 171, 199, 227, 255, 283, 311, 339, and at the End of Study visit. Measurement of HACA development in plasma was performed with a BIAcore 2000 biosensor (Biacore AB, Uppsala, Sweden), using the BDF TM015 method. HACA positivity was defined as an increase in binding evident in the test channel but not in the control channel, with positivity assigned for values exceeding a uniform test threshold.|From baseline through up to 17 months post-baseline|Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and had at least 1 post-baseline plasma sample evaluated for HACA.|||Participants|||Count of Participants
1228096|NCT00679289|Secondary|Number of Patients With Best Overall Tumor Response|Tumor responses were evaluated using whole body computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0) at Screening, on Days 29, 57, 85, 115, 143, 171, 227, 283, 339, and at the End of Study Visit. Patients who were treated beyond 49 weeks were to undergo clinical and radiologic assessments per the standard of care. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|From baseline through up to 17 months post-baseline|Patients who received initial treatment with HDI and at least 1 infusion of KW2871.|||Participants|||Count of Participants
1228097|NCT00679289|Primary|Number of Patients With Treatment-emergent Adverse Events (TEAEs)|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or Grade 5 (fatal). TEAEs were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Causal relationship of each TEAE to study treatment was evaluated by the investigator separately for HDI and KW2871. Regimen-limiting toxicity was defined as an HDI-related dose-limiting toxicity (DLT) that required more than 2 dose reductions of HDI during the induction phase or the first 4 weeks of the maintenance phase, or any KW2871- or regimen-related DLT.|From baseline through up to 17 months post-baseline|Patients who received initial treatment with HDI and at least 1 infusion of KW2871.|||Participants|||Count of Participants
1228098|NCT00679289|Primary|Median Progression-free Survival (PFS) With 95% Confidence Intervals|PFS was calculated from the date of the first infusion to the date of documented progression or death, whichever occurred first. PFS analyses were performed using Kaplan-Meier methods for all patients combined and for patients in Cohort 3. Based on published results from Phase 3 randomized clinical trials in patients with metastatic melanoma at the time of study initiation, 2.5 months was estimated as a conservative (i.e., somewhat high) external standard of median PFS. The intent of this study was to improve this standard by ≥ 70% to a median PFS of ≥ 4.3 months for patients treated with KW2871 combined with HDI. If the therapeutic target of 4.3 months for median PFS represented the true underlying treatment effect of KW2871 plus HDI, then 23 patients would provide 80% power to detect a statistically significant improvement (α = 0.05; 1-sided test) over the 2.5-month external standard.|From baseline through up to 17 months post-baseline|Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and experienced a PFS event (progression or death).|||months||95% Confidence Interval|Median
1228099|NCT00679263|Secondary|FEV1 Percent Predicted Changes From Base Line|The primary efficacy variable will be the change from baseline in FEV1, expressed as percent of predicted at hour 1 after the start of the infusion. Analysis of all other variables at all other time points will be considered secondary.|Day 1 to Day 2||||FEV1 percent predicted||Standard Deviation|Mean
1228100|NCT00679263|Primary|Number of Patients Reported to Have Adverse Events||Day 1 to Day 2||||participants|||Number
1228174|NCT00678639|Secondary|The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging|The number of participants able to complete the planned imaging sequences will be measured.|Emergency Department (ED) arrival through hospital discharge|All participants randomized to the Observation Unit - Cardiac Magnetic Resonance Imaging (OU-CMR) arm were analyzed based on intention to treat.|||Participants|||Number
1228738|NCT00674128|Primary|Reported Here Are the Number of Participants With Devices That Developed Infection||Within 3 months after surgery.||||participants|||Number
1228101|NCT00679211|Secondary|Percentage of Participants With Clinical Benefit Based on Investigator Assessment|Clinical benefit was defined as participants with an objective response (confirmed complete or partial response) or stable disease at 6 months. Patients with stable disease at 6 months were defined as patients who achieved at least stable disease based on tumor assessments and remained alive and progression free at 6 months. Response was based on the Investigator's assessment.|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Patients without a post-baseline tumor assessment were considered to have experienced no clinical benefit.|||percentage of participants||95% Confidence Interval|Number
1228102|NCT00679211|Secondary|Duration of Objective Response Based on Investigator Assessment|"For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was determined by the Investigator's assessment.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Participants with an objective response.|||months||95% Confidence Interval|Median
1228103|NCT00679211|Secondary|Progression-free Survival Based on Investigator Assessment|"Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population|||months||95% Confidence Interval|Median
1228104|NCT00679211|Secondary|Objective Response Based on Investigator Assessment|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Response was assessed by the study Investigator.~CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.~PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Participants without a post-baseline tumor assessment were considered to be non-responders.|||percentage of participants||95% Confidence Interval|Number
1228105|NCT00679211|Secondary|Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review|"Clinical benefit was defined as participants who achieved an objective response (confirmed complete or partial response) between randomization and 1 January 2010, or with stable disease at 6 months. Stable disease at 6 months was defined as participants who achieved at least stable disease based on tumor assessments by the independent review facility, and remained alive and progression-free at 6 months.~Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, and no new lesions and/or unequivocal progression of existing nontarget lesions. Response was assessed by the independent review facility."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Participants without a post-baseline tumor assessment were considered to have experienced no clinical benefit.|||percentage of participants||95% Confidence Interval|Number
1228106|NCT00679211|Secondary|Progression-free Survival as Assessed Through Independent Radiologic Review|"Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Disease progression was assessed by the independent review facility.~For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population.|||months||95% Confidence Interval|Median
1228107|NCT00679211|Secondary|Duration of Objective Response as Assessed Through Independent Radiologic Review|"For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant’s objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was assessed by the independent review facility.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Participants with an objective response.|||months||95% Confidence Interval|Median
1228108|NCT00679211|Primary|Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST).~CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.~PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions.~The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled)."|From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled).|Treated population (patients who received at least one dose of T-DM1). Participants without a post-baseline tumor assessment were considered to be non-responders.|||percentage of participants||95% Confidence Interval|Number
1228109|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Fold Change in IgG.|Number and proportion of subjects with 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).|From baseline (pre-dose) to Day 28.|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
1228110|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of ASCs Secreting IgA.|Number and proportion of subjects with ≥ 4 ASCs per 10^6 PBMCs at Day 7 secreting IgA specific for S. typhi LPS (detected by ELISPOT).|Day 7.|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
1228111|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of Antibody Secreting Cells (ASCs) Secreting IgA and/or Fold Change in IgG.|Number and proportion of subjects with ≥ 4 ASCs per 10^6 peripheral blood mononuclear cells (PBMCs) at Day 7 secreting IgA specific for S. typhi LPS (detected by enzyme-linked immunospot assay [ELISPOT]) AND/OR 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).|At Day 7 (IgA); and from baseline (pre-dose) to Day 28 (IgG).|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
1228112|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.|Number and proportion of subjects with an increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 7, 14 or 28. Serum IgG was assayed using ELISA.|From baseline (pre-dose) to Days 7, 14, or 28.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 14.|||Participants|||Count of Participants
1228113|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.|Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28. Serum IgG was assayed using ELISA.|From baseline (pre-dose) to Days 14 or 28.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
1228114|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgA Antibodies for S. Typhi LPS.|Number and proportion of subjects with increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgA was assayed using ELISA.|From baseline (pre-dose) to Days 7 or 14.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
1228115|NCT00679172|Primary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG and/or IgA Antibodies for S. Typhi Lipopolysaccharide (LPS).|Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28 AND/OR increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgG and IgA were assayed using enzyme-linked immunosorbent assay (ELISA).|From baseline (pre-dose) to Days 14 or 28 (IgG) or to Days 7 or 14 (IgA).|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
1228116|NCT00679172|Primary|Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC‾ssaV‾) ZH9.|Number of subjects having shedding in stool of S. typhi (Ty2 aroC‾ssaV‾) ZH9. Subjects were evaluated beyond Day 14 only in Cohort 4.|Beyond 7 days post-dosing through 14 days post-dosing (Cohorts 1-3) or through 21 days post-dosing (Cohort 4).|Safety Population: All subjects who received a dose of study medication.|||participants|||Number
1228117|NCT00679172|Primary|Number and Proportion of Subjects Experiencing Bacteraemia.|Number and proportion of subjects experiencing a proven bacteraemia attributed to the vaccine strain S. typhi (Ty2 aroC‾ssaV‾) ZH9.|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||Participants|||Count of Participants
1228118|NCT00679172|Primary|Number of Subjects Reporting Treatment-related TEAEs.|"Number of subjects having TEAEs considered by the principal investigator to be possibly or probably related to treatment."|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||participants|||Number
1228119|NCT00679172|Primary|Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.|Number of subjects having clinically significant changes in clinical laboratory test parameters.|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||participants|||Number
1228127|NCT00679055|Secondary|Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized.|up to 14 weeks|All enrolled participants who received at least one dose of study drug.|||Particpants|||Number
1228128|NCT00679055|Secondary|Change From Baseline in Messenger Ribonucleic Acid (mRNA)|mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.|Baseline and Week 12|Study terminated early. Planned analyses was not performed.||||||
1228129|NCT00679055|Primary|Change From Baseline in Cluster of Differentiation 68 (CD68)|CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.|Baseline and Week 12|Study terminated early. Planned analyses was not performed.||||||
1228130|NCT00679029|Primary|Overall Survival as Assessed by the Kaplan and Meier Method||From the date of first treatment to the date of death, assessed up to 100 months||||percentage of participants||95% Confidence Interval|Number
1228131|NCT00679029|Primary|Disease-free Survival as Assessed by the Kaplan and Meier Method||From the date of first treatment to the date of disease progression/recurrence, second cancer, or death, whichever came first, assessed up to 5 years|report below of estimated disease free survival at 5 years|||percentage of participants||95% Confidence Interval|Number
1228132|NCT00679029|Primary|Count of Participants With Related SAEs by NCI Common Toxicity Criteria v3.0|Assess the safety of Avastin in the adjuvant setting particularly regarding cardiac function, wound healing and toxicity of radiation.|through study completion, an average of 10 months||||Participants|||Count of Participants
1228133|NCT00679029|Primary|Percentage of Participants With Study Drug-associated Adverse Events Leading to Dose Holds or Reductions|This outcome is to measure the feasibility of the of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting in women with stage II and III breast cancer that does not over-express HER 2/neu|through study completion, an average of 10 months||||percentage of participants||95% Confidence Interval|Number
1228134|NCT00678899|Secondary|AzBio Sentence Score-Treated Ear|"Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:~The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in'unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported."|6 Months Postactivation||||percentage of subjects|||Number
1228135|NCT00678899|Secondary|Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear|"Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:~The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported."|6 Months Postactivation||||percentage of subjects|||Number
1228136|NCT00678899|Primary|AzBio Sentence Score in Noise - Treated Ear (Co-Primary)|"The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.~The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score."|6 Months Postactivation||||percentage of words correct||Standard Deviation|Mean
1228137|NCT00678899|Primary|Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)|"The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.~The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study."|6 Months Postactivation||||percentage of words correct||Standard Deviation|Mean
1228138|NCT00678886|Secondary|Percent Change From Baseline in CD3/TCR Modulation on CD4+ T Cells and CD8+ T Cells at Day 1, Day 4, Day 8|The extent of modulation of CD3/TCR receptors on CD4+ and CD8+ lymphocytes was determined by flow cytometry. The extent of TCRαβ expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites.CD3/TCR complexes on CD4+ and CD8+ T cells were detected with a non-competing antibody. Changes in the MESF of TCR expression was a direct measurement of TCR modulation. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (Pre-dose Day 1), Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Error|Mean
1228139|NCT00678886|Secondary|Percent Change From Baseline in CD3/TCR Saturation on CD4+ T Cells and CD8+ T Cells at Day 1, Day 4, Day 8|The extent of saturation of CD3/TCR receptors on CD4+ and CD8+ lymphocytes was determined by flow cytometry. The extent of TCRαβ expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites. MESF of free CD3 sites on CD4+ T cells and CD8+ T cells was direct measurement of saturation of the CD3/TCR complex on CD4+ T cells and CD8+ T cells. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (Pre-dose Day 1), Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Error|Mean
1228140|NCT00678886|Secondary|Percent Change From Baseline in Cell-bound Otelixizumab on CD4+ T Cells at Day 1, Day 4, Day 8|The amount of cell-bound otelixizumab was determined by flow cytometry. The extent of T cell receptor alpha beta (TCRαβ) expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. Free otelixizumab binding sites (sites not occupied by otelixizumab) were detected by staining with biotinylated otelixizumab. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites. MESF of bound antibody on CD4+ T cells was a direct measurement of cell-bound otelixizumab on CD4+ T cells. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (pre-dose on Day 1), Day 4 and Day 8|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Error|Mean
1228141|NCT00678886|Secondary|Percent Change From Baseline in Circulating Peripheral Lymphocytes CD4+CD25+FoxP3+ T Cells and CD4+CD25hiFoxP3+ T Cells in Type 1 Diabetes Mellitus (TIDM) up to Month 12|Blood samples were drawn for lymphocyte subset evaluations at Baseline and at 2hours after EOI on Day 4, pre-dose and after E0I on Day 8, Day 14, Day 21, Day 28, Week 6, Week 8, Week 10, Week 12, Month 6 and Month 12. Percentages of relevant lymphocyte subsets were determined by flow cytometry. The lymphocyte subsets assessed included CD8+CD25+ T lymphocytes, as well as the subsets of lymphocytes of these type that were positive for FoxP3, a protein that was expressed at high levels in the cytoplasm of regulatory T cells. CD4+CD25hiFoxP3+ T lymphocytes, a cell type was of interest because it played a regulatory role in T1DM. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (pre-dose on Day 1) and up to 12 Months|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Full Range|Median
1228142|NCT00678886|Secondary|Change From Baseline in Level of Cytokines Interleukin (IL-6), IL-10 and Tumor Necrosis Factor-alpha (TNF-a) at Day 1, Day 4, Day 8|Levels of cytokine (TNFα, IL-6, IL-10) were measured at Baseline and at 2 hours after end of infusion (EOI) on Day 1, Day 4, Day 8 . Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Day 1, Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter||Standard Error|Mean
1228143|NCT00678886|Secondary|Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use at Month 6 and Month 12|O’Brien analyses will be performed on a three-part composite of HbA1c level, C-peptide AUC, and mean daily Insulin use in the otelixizumab group compared with the placebo group at Months 6 and12. For the O’Brien mean rank analysis at a particular time point, HbA1c and insulin use will be ranked from smallest to largest, and C-peptide AUC will be ranked from largest to smallest. For each participant, the C-Peptide AUC, ranks for HbA1c and insulin use were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks.|Month 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Composite rank score||Standard Deviation|Mean
1228144|NCT00678886|Secondary|Composite Rank Summary for HbA1c and Exogenous Insulin Use at Month 6 and Month 12|O’Brien mean rank analyses was performed on a two-part composite of the baseline-adjusted HbA1c level and the baseline-adjusted mean total daily insulin use per kg body weight in the otelixizumab group compared with the placebo group at Months 6, 12. For the O’Brien mean rank analysis at a particular time point, adjusted HbA1c values (for both treatment groups together) was ranked from smallest to largest, and adjusted mean daily insulin use values were ranked from smallest to largest. For each participant, the HbA1c and insulin use ranks were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks.|Month 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Composite rank score||Standard Deviation|Mean
1228145|NCT00678886|Secondary|Change From Baseline in Average Daily Risk Range (ADRR) at Week 12 and Months 6 and 12.|Average daily risk range is a measure for evaluation of blood glucose variability that was designed to be equally sensitive to hypoglycemia and hyperglycemia. The ADRR was assessed over 30-day periods prior to Baseline and at key visits Week 12 and Months 6 and 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Week 12 and Months 6 and 12.|Baseline (Day 1) and Week 12, Months 6 and 12.|ITT population.|||Ratio||Standard Error|Least Squares Mean
1228175|NCT00678639|Secondary|Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days|Participants with ACS and admitted or not experiencing ACS and discharged will be considered a correct admission decision. Remaining participants will be considered to have incorrect admission decisions.|30 Days|4 participants (3 in the usual care group and 1 in the ED obs unit group) left Against Medical Advice (AMA) prior to completion of their evaluation and were excluded from this analysis. Analysis was per intention to treat.|||Participants|||Number
1228146|NCT00678886|Secondary|Number of Participants With Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12|Percentage of hyperglycemic excursions was calculated as the total number of observations that exceed the hyperglycemic excursion boundary (i.e. > HGTLV) divided by the total number of glucose measurements recorded in a time interval for the intervals: Baseline to Week 12, post-Week 12 to Month 6, post-Month 6 to Month 12. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected. Data for number of participants with their percentages are presented.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1228147|NCT00678886|Secondary|Magnitude of Greatest Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|The greatest hyperglycemic excursions during an interval was calculated as the largest recorded glucose level in the interval minus the hyperglycemic tolerance limit value (HGTLV). If a participant had data recorded during the interval but did not have a value above the HGTLV, the participants greatest hyperglycemic excursion for that interval was 0 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.|||milligrams per deciliter||Standard Error|Mean
1228148|NCT00678886|Secondary|Number of Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|The event frequency of glucose measurements that were hyperglycemic excursions were calculated on a per participant basis using the number of occurrences where blood glucose was greater than the hyperglycemic tolerance limit. There were 3 hyperglycemic tolerance limits considered: 200 mg/dL, 130 mg/dL and 100 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Hyperglycemic excursions||Standard Error|Mean
1228149|NCT00678886|Secondary|Number of Participants With Hypoglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12|Percentage of hypoglycemic excursions was calculated as the total number of observations that exceed the hypoglycemic excursion boundary (i.e.<= 70 mg/dL) divided by the total number of glucose measurements recorded in a time interval for the intervals: Baseline to Week 12, post-Week 12 to Month 6, post-Month 6 to Month 12. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected. Data has been presented for number of participants with their percentages having hypoglycemic excursion.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1228150|NCT00678886|Secondary|Magnitude of Greatest Hypoglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|"The greatest hypoglycemic excursions during an interval was calculated as 70 mg/dL minus the lowest recorded glucose level in the interval. If a participant had data recorded during the interval but did not have a value below 70 mg/dL, the participants greatest hypoglycemic excursion for that interval was 0 mg/dL.~Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected."|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.|||milligrams per deciliter||Standard Error|Mean
1228151|NCT00678886|Secondary|Number of Hypoglycemic Excursions (<=70 mg/dL) With Most Complete Glucose at Week 12 and Months 6 and 12.|The event frequency of glucose measurements that were hypoglycemic excursions were calculated per participant basis, using the number of occurrences where blood glucose was less than or equal to 70 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.|||Hypoglycemic excursions||Standard Error|Mean
1228176|NCT00678639|Primary|Cost of Index Hospitalization|Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.|Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours|All participants were analyzed based on intention to treat.|||US Dollars||Inter-Quartile Range|Median
1228152|NCT00678886|Secondary|Number of Participants With Hypoglycemic Events Defined by Hypoglycemic Event Categories From Baseline Upto Month 12|Hypoglycemic events reported by participants were classified as defined by the ADA Workgroup on Hypoglycemia as Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon/other resuscitative actions, documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration (PGC)<=70 mg/dL, asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured PGC<=70 mg/dL,probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia are not accompanied by a plasma glucose determination, but were presumably caused by a PGC<=70 mg/dL and relative hypoglycemia: an event during which the person with diabetes reports any of the typical symptoms of hypoglycemia, and interprets the symptoms as indicative of hypoglycemia, but with a measured PGC>70 mg/dL. Only categories with values are presented.|Upto Month 12|ITT population. Data has been presented for number of participants with their percentages with hypoglycemic events defined by hypoglycemic event categories from Baseline upto month 12.|||Participants|||Count of Participants
1228153|NCT00678886|Secondary|Number of Hypoglycemic Events Defined by Hypoglycemic Event Categories From Baseline Upto Month 12|Hypoglycemic events reported by participants were classified as defined by the American Diabetes Association (ADA) Workgroup on Hypoglycemia as follows: Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon/other resuscitative actions, documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration(PGC)<=70 mg/dL, asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured PGC<=70 mg/dL,probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia are not accompanied by a plasma glucose determination, but were presumably caused by a PGC<=70 mg/dL and relative hypoglycemia: an event during which the person with diabetes reports any of the typical symptoms of hypoglycemia, and interprets the symptoms as indicative of hypoglycemia, but with a measured PGC>70 mg/dL.|Upto Month 12|ITT population.|||Hypoglycemic events|||Number
1228154|NCT00678886|Secondary|HbA1c Level at Week 12 and Months 6 and 12|HbA1c levels were recorded at Screening, Baseline (Day 1), Day 28, Week 8, Week 12, Months 4 to 12 and Month 24. Data has been presented for HbA1c levels at Week 12 and Months 6 and 12.|Week 12 and Months 6 and 12|ITT population.|||Percentage||Standard Error|Least Squares Mean
1228155|NCT00678886|Secondary|Mean Daily Insulin Use at Week 12 and Months 6 and 12.|Participants recorded their daily insulin use in their electronic diaries. In particular, insulin was recorded thoroughly and accurately for at least 7 consecutive days during the 2 weeks before the visits at Baseline, Week 12, and Months 6 and 12. During each of these visits, the investigator/designee accessed the invivodata DiaryPRO web site to review insulin-use data for the previous 2-week period to ensure completeness. If errors/gaps were identified (e.g., if the participant did not take insulin and not entered 0 units), the investigator/designee recorded the missing data from participant recall using a data clarification form (DCF). Paper diary to collect insulin use, were reviewed for completeness. Any missing data that could be recalled by the participant was entered. If the participant did not record any insulin use during the 2-week period before the visit, the site obtained an insulin use history for the previous 7 days and calculated the average daily insulin dose.|Week 12 and Months 6 and 12.|ITT population.|||IU/kg||Standard Error|Least Squares Mean
1228156|NCT00678886|Secondary|Number of Participants Who Were Responders for (Glycosylated Hemoglobin) HbA1c/Insulin Use Response at Week 12 and Months 6 and 12|A participant was considered a responder if, at the given time point, the participant had HbA1c<= 6.5%, and mean daily insulin use over 7 consecutive days < 0.5 international units per kilogram per day (IU/kg/day) during the 2 weeks preceding the visit. Data has been presented from number of participants with their percentages who were responders at Week 12 and Months 6 and 12.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1228157|NCT00678886|Primary|Change From Baseline in 2-hour Mixed Meal Stimulated C-peptide Area Under Curve [AUC] (Normalized for 120-minute Time Interval) at Month 12|Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from Time 0 to 120 minutes, calculated using the trapezoidal rule. This reported AUC was normalized for time interval by dividing it by 120 minutes. This normalized AUC was calculated for each participant at Baseline, Week 12, and at Months 6, 12, 18, and 24. Data has been presented for meal stimulated C-peptide Area under assessment performed at Month 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Month 12.|Baseline (0-120 minutes on Day 1) and Month 12 (0-120 minutes)|Intent-to-treat (ITT) population, comprised of all participants who were randomized and received any part of at least 1 infusion of study drug.|||nanomoles per liter||Standard Error|Least Squares Mean
1228158|NCT00678834|Primary|"The Levels of TCT in the Tissues of Non-healthy Subjects and in the Tissue of Healthy Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)"||After at least 1 month of supplementation|Box plots were used to determine outliers defined as values . the 75th percentile plus 1.5 times the IQR or values , the 25th percentile minus 1.5 times the IQR (20). Outliers were identified and it was determined that laboratory procedural errors were the cause and thus removed from the analysis.|||nmol/g||Standard Deviation|Mean
1228159|NCT00678795|Secondary|Change From Baseline in the Mean Number of Daily Voids at the End of Treatment|Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||number of daily episodes||Standard Deviation|Mean
1228160|NCT00678795|Secondary|Patient’s Global Impression of Change|Subjects were asked at completion or withdrawal to give their impression of the overall change in their condition since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’. The numbers who scored 1, 2, or 3 are presented.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
1228161|NCT00678795|Secondary|Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment|Subjects subjectively assessed the severity of their urinary incontinence and general bladder symptoms by responding to the following question on a Numerical Rating Scale: My bladder condition, taking everything into account, causes me: 0 = “no problems” and 10 = “intolerable problems”. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1228162|NCT00678795|Secondary|Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal)|The I-QOL consists of 22 items from three subscales; avoidance/limiting behaviour (eight items), psychosocial impact (nine items) and social embarrassment (five items). The responses to each of the 22 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation. The transformation formula used for the I-QOL total scores is: Transformed score = 100 x (the sum of the items - lowest possible score) / Possible raw score range. An increase in score indicates an improvement in QOL.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1228163|NCT00678795|Secondary|Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment|Subjects documented in the daily subject diary, the total number of incontinence pads they had used each day. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||pads used daily||Standard Deviation|Mean
1228164|NCT00678795|Secondary|Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment|Subjects documented in the daily subject diary each instance of nocturia, and the time that each took place (as for the recording of incontinence episode frequency). Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||number of daily episodes||Standard Deviation|Mean
1228165|NCT00678795|Secondary|Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment|Subjects documented in the daily subject diary each instance of urgency, and the time that each took place, as for the recording of incontinence episode frequency. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|Daily diary entries throughout 10 week study period|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||number of daily episodes||Standard Deviation|Mean
1228166|NCT00678795|Primary|Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment|To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||number of daily episodes||Standard Deviation|Mean
1228167|NCT00678691|Primary|Brief Fatigue Inventory|This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue|8 weeks|last observation carried forward after power analysis calculated|||units on a scale||Standard Deviation|Mean
1228168|NCT00678652|Secondary|Total Antibody Response to the Parent Strain of Group B Meningococcus|Assess and characterize bactericidal activity and total antibody response against the vaccine strain and other strains of Group B Meningococcus induced by 3 injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.|126 days||||ug/mL||Full Range|Median
1228169|NCT00678652|Primary|Rate of Seroconversion After the 3rd Dose of 8570 L3-5, 7-5 Vaccine|Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 3rd dose of vaccine|84+7 days (visit 11)|Seroconversion is defined as a 4-fold or greater increase from baseline in antibody titer of bactericidal antibodies after 3 doses of vaccine|||Participants|||Count of Participants
1228170|NCT00678652|Primary|Rate of Seroconversion After the 2nd Dose of 8570 L3-5,7-5 Vaccine|Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 2nd dose of vaccine|42+7 days (visit 7)|Seroconversion is defined as a 4-fold or greater increase from baseline in antibody titer of bactericidal antibodies after 2 doses (the first and second) of vaccine.|||Participants|||Count of Participants
1228171|NCT00678652|Primary|Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections|Measure the bactericidal absolute values per dose group after vaccine injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.|18 weeks. Days 0, 14, 56, 84, 98 and 126||||titers||Standard Deviation|Mean
1228172|NCT00678639|Secondary|Adverse Events During Magnetic Resonance Imaging (MRI) Scanning|Any event leading to early termination of the MRI acquisition, or requiring intervention by a physician, will be considered an adverse event related to MRI, excluding physician termination of image acquisition due to concerns of cardiac ischemia.|Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.|Only participants undergoing Cardiac MRI scanning are eligible for this endpoint. Only 49 of the 53 participants randomized to observation unit arm underwent CMR testing. Nine participants in the usual care arm underwent CMR testing.|||Participants|||Number
1228177|NCT00678587|Secondary|Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures|The number of unscheduled events was analyzed as an indication of medical resource utilization throughout the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population. Data are missing for some participants.|||unscheduled events||Standard Deviation|Mean
1228178|NCT00678587|Secondary|Mean Number of Days Spent in the Hospital|The number of days spent in the hospital was analyzed as an indication of medical resource utilization throughout the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population. Data are missing for some participants.|||days||Standard Deviation|Mean
1228179|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, CL/F|CL/F is the apparent plasma clearance, where CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. Total clearance is the volume of blood cleared of the drug by the various elimination processes (metabolism and excretion) per unit time.|Day 14|PK Subpopulation|||Liters/hour||95% Confidence Interval|Geometric Mean
1228180|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, t1/2|t1/2 is the half life of a drug based on its terminal phase. Half life is defined as the time necessary to halve the plasma concentration.|Day 14|PK Subpopulation|||hours||95% Confidence Interval|Geometric Mean
1228181|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, Cmax|Cmax is the steady state peak plasma concentration of a drug observed after its administration.|Day 14|PK Subpopulation|||ug/mL||95% Confidence Interval|Geometric Mean
1228182|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)|AUC(0-tau) is the area under a concentration versus time curve between dose interval following repeat dosing. It is a measure of systemic drug exposure.|Day 14|PK Subpopulation: all participants who were treated with eltrombopag and provided evaluable PK samples|||hour*micrograms (ug)/milliliter (mL)||95% Confidence Interval|Geometric Mean
1228183|NCT00678587|Secondary|Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results|A 12-lead ECG was obtained in duplicate at screening, baseline, Day 15, and withdrawal from the study. Participants rested supine for 5 minutes before the 12-lead ECG was recorded. A 30 second rhythm strip was obtained, and the ECG was calibrated, labelled, and initialled by the person performing the recording. A written, interpretive assessment detailing clinical significance was produced, dated, and signed off by the physician at the site.|Screening, Baseline, Day 15, and Withdrawal|Safety Population. Data were missing for some participants.|||participants|||Number
1228184|NCT00678587|Secondary|Number of Participants With Renal Function Abnormality|Renal function abnormality was defined by threshold values for: serum creatinine: change from baseline of >=0.3 and <0.5 milligrams (mg)/deciliter (dL) (>=26.6 and <44.3 micromoles [umol]/L) or change from baseline of >=0.5 mg/dL (>=44.3 umol/L); microscopic urine analysis: cellular casts pathologic (as defined by local standards of microscopic urine analysis); urine protein/creatinine ratio (UP/CR): >0.5 mg/mg; Glomerular Filtration Rate (GFR) as determined by the Cockcroft-Gault formula and urine dipstick test.|Screening to Procedure +30 day follow-up or early withdrawal|Safety Population|||participants|||Number
1228185|NCT00678587|Secondary|Number of Participants With the Indicated Event Relating to Vision|The progression of pre-existing cataracts was measured by the use of slit lamp examination. Decrease in visual acuity is defined as the loss of 3 or more lines of visual acuity in either eye (0.3 log minimal angle of resolution [logMAR], 15 letters on the standard Early Treatment Diabetic Retinopathy Study chart).|Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit)|Safety Population: all randomized participants who received at least one dose of study medication. Data are missing for some participants.|||participants|||Number
1228186|NCT00678587|Secondary|Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant||Screening to Procedure +30 day follow-up or early withdrawal|Safety Population|||participants|||Number
1228187|NCT00678587|Secondary|Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect or an ocular event of clinical concern. Medical or scientific judgement is exercised in deciding whether reporting is appropriate in other situations.|Screening to Procedure +30 day follow-up or early withdrawal|Safety population: all randomized participants who received at least one dose of study medication|||participants|||Number
1228188|NCT00678587|Secondary|Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline|Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).|Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline|ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.|||participants|||Number
1228189|NCT00678587|Secondary|Median Platelet Count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 Day Follow-up; Early Withdrawal; and Maximum Post-baseline|Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).|Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline|ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.|||Gi/L||Full Range|Median
1228190|NCT00678587|Secondary|Number of Participants With the Indicated Number of Platelet Transfusions Administered|Platelet transfusion use was documented at every visit throughout the study from screening until the 4-week (30-day) post-procedure follow-up visit or at the time of participant withdrawal from the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population|||participants|||Number
1228191|NCT00678587|Secondary|Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures|The WHO Bleeding Scale was used to assess bleeding during the study. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).|Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population|||participants|||Number
1228192|NCT00678587|Primary|Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures|A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.|Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26|Intent-to-Treat (ITT) Population: all participants who were randomized to treatment|||participants|||Number
1228193|NCT00678574|Primary|Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment|GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.|2-3 months post-treatment w/ fluoxetine.|This study was conducted at Yale several years ago. Our group at UPenn only has basic information about this study. This includes the number of participants, which was 18, and that no adverse events occurred. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania.||||||
1228194|NCT00678535|Secondary|Safety - Number of Participants With Adverse Events (AEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|The safety population included all participants who received at least one dose of any trial treatment that is, cetuximab, cisplatin, or capecitabine.|||participants|||Number
1228195|NCT00678535|Secondary|Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire|EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Analysis population included participants who had at least one evaluable EuroQoL EQ-5D questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1228196|NCT00678535|Secondary|Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|Mean global health status and social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Analysis population included participants who had at least one evaluable EORTC QLQ-C30 questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1228197|NCT00678535|Secondary|Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments|The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) from the IRC.|Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
1228198|NCT00678535|Secondary|Overall Survival (OS)|The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1228199|NCT00678535|Primary|Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1228231|NCT00678301|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
1228200|NCT00678470|Primary|Number of Patients Who Were Both Intralesional and Intramuscular Responders.|"Patients were first injected with alefacept into a single target plaque. Those who had improvement in the plaque from baseline were deemed intralesional responders. All the patients then were injected with alefacept intramuscularly. The patients who had a 70% or greater improvement in their psoriasis severity score (includes assessment of entire body) were systemic responders to alefacept. The number of patients who were both intralesional and systemic responders was measured."|12 weeks after intramuscular injection of alefacept.|14 of 18 patients completed the study.|||Participants|||Number
1228201|NCT00678470|Primary|To Evaluate the Effectiveness of Intralesional Alefacept Administration as Defined by the Psoriasis Severity Assessment Score Followed by the Evaluation of the Effectiveness of Intramuscular Alefacept Administration.||6 months|||||||
1228202|NCT00678444|Secondary|Patient Satisfaction Scores - Visual Analogue Scores (VAS).|"Secondary study measures included a study-specific visual analog scales (VAS, range 0–100 mm) to assess comfort with Clean Intermittent Self-Catheterization (CISC) and opinions on the CISC video.~Higher VAS scores represent higher levels of comfort with CISC."|Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively||||participants|||Number
1228203|NCT00678444|Primary|State-Trait Anxiety Inventory-State Scores|The STAI-S scale is a 20-item, Likert-type, validated measure, scored 20-80 with higher scores reflecting higher situational anxiety. STAI-S is designed to specifically assess current anxiety as opposed to baseline trait anxiety. Respondents rated their current feelings specific to bladder catheterization by answering items regarding bladder catheterization such as, “I feel at ease” or “I feel upset.” Responses ranged from 1 to 5 from “not at all” to “very much so.”|Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively||||units on a scale||Standard Deviation|Mean
1228204|NCT00678418|Secondary|Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24|Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.|24 Weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). Change from baseline was calculated per subject as the percent of subjects' self-reported opioid-free days in Part A minus the percent of opioid-free days prior to the subjects' hospitalization for pre-study detoxification.|||Percentage of opioid-free days||Inter-Quartile Range|Median
1228205|NCT00678418|Secondary|Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)|Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence.|24 Weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).|||Percentage of participants who relapsed|||Number
1228206|NCT00678418|Secondary|Craving Score: Change From Baseline|"Measured using subjects' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 (No craving) to 100 (highest possible craving)."|Baseline to 6 months (24 weeks)|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).|||Units on a scale||95% Confidence Interval|Least Squares Mean
1228207|NCT00678418|Secondary|Days to Discontinuation During Part A|Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.|168 days (24 weeks)|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).|||Days to study discontinuation||95% Confidence Interval|Median
1228208|NCT00678418|Primary|Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)|Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.|20 weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (Intent-to-treat [ITT] population).|||Percentage of opioid-free weeks||Inter-Quartile Range|Median
1228209|NCT00678392|Secondary|Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."|||Units on a scale||Standard Deviation|Mean
1228210|NCT00678392|Secondary|Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."|||Units on a scale||Standard Deviation|Mean
1228232|NCT00678301|Secondary|Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off|The cut-off for the assay was > 39.0°C.|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
1234212|NCT00627406|Primary|Frequency of Moderate to Severe OHSS.||From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test|No power calculation was proformed.|||participants|||Number
1228211|NCT00678392|Secondary|Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score|FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."|||Units on a scale||Standard Deviation|Mean
1228212|NCT00678392|Secondary|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score|FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."|||Units on a scale||Standard Deviation|Mean
1228213|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis|Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."|||Participants|||Number
1228214|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry|Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."|||Participants|||Number
1228215|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology|Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."|||Participants|||Number
1228216|NCT00678392|Secondary|Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life ­threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non ­serious AEs.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of participants|||Number
1228217|NCT00678392|Secondary|Percentage of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of participants|||Number
1228218|NCT00678392|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non­serious AEs.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of participants|||Number
1228219|NCT00678392|Secondary|Duration of Response (DR)|DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1228220|NCT00678392|Secondary|Objective Response Rate (ORR)|ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1228221|NCT00678392|Secondary|Overall Survival (OS)|OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1228222|NCT00678392|Primary|Progression-Free Survival (PFS)|PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1228223|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate a Regular Diet|The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.||||Participants|||Count of Participants
1228224|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate Only a Soft Diet|The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.|per group diet|||Participants|||Count of Participants
1228225|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate Only Liquids|The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.|per group data|||Participants|||Count of Participants
1228226|NCT00678379|Secondary|Mean Visual Analog Scale Pain Number.|Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever|in recovery room; post-operative days 1,3,5 & 7||||pain score||Full Range|Mean
1228227|NCT00678379|Secondary|Total Time Until Discharge From Hospital.||Day of Surgery||||minutes||Full Range|Median
1228228|NCT00678379|Secondary|Median Number of Pain Medication Doses|The median number of intravenous fentanyl doses administered in the PACU due to pain|in recovery room|per group doses|||number of doses||Full Range|Median
1228229|NCT00678379|Primary|Total Number of Post-operative Doses of Analgesics.|The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)|Post-operative thru day 7|Number of patients randomized to each group|||number of doses||Full Range|Median
1228230|NCT00678301|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|Throughout the entire study period, from Month 0 to Month 3|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
1228264|NCT00678249|Secondary|Percent of Participants With Access Circuit Primary Patency (ACPP)|ACCP defined as patency (open to blood flow) following the index study procedure until access thrombosis or an intervention of a lesion anywhere within the access circuit.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
1228233|NCT00678301|Secondary|Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. “Any” was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) greater than (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all.|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
1228234|NCT00678301|Secondary|Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm). “Any” was defined as incidence of the specified symptom regardless of intensity.|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
1228235|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Anti-Hepatitis B Surface Antigen (HBs) Antibodies.|The seroprotection cut-off values considered for this endpoint were an anti-HBs antibody concentration ≥ 10 and 100 milli-international units per millliter (mIU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228236|NCT00678301|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|The seroprotection cut-off for the endpoint was an anti-HBs antibody concentration ≥ 10 milli-international units per millliter (mIU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1228237|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies ≥ the Cut-off|Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 1 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228238|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies ≥ the Cut-off.|Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 0.15 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228239|NCT00678301|Secondary|Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were measured and tabulated in microgram per milliliter (μg/mL). Cut-off for the assay was ≥ 0.15 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1228240|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibodies|A seroprotected subject as regards anti-D/-TT antibodies was defined as a subject with an Anti-D/-TT antibody concentration ≥ 0.1 IU/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228241|NCT00678301|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|The seroprotection cut-off for the assay was an anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international unit per millliter (IU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1228242|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Anti-Bordetella Pertussis (Anti-BPT) Antibodies|Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL).|At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228332|NCT00677820|Secondary|Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7||Days 0-7|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
1228243|NCT00678301|Secondary|Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations|Anti-BPT antibody concentrations were expressed in enzyme-linked immunosorbent assay (ELISA) unit per millilitre (EL.U/mL). Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentrations ≥ 15 EL.U/mL|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1228244|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228245|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228246|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Antibodies Against Protein D (Anti-PD Antibodies)|Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228247|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19 A. Seroprotection cut-off for the assay was an anti-6A/19A antibody concentrations ≥ 0.2 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228248|NCT00678301|Secondary|Number of Subjects Seropositive as Regards Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228249|NCT00678301|Secondary|Number of Subjects Seroprotected as Regards Antibodies Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seroprotection cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.2 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228250|NCT00678301|Secondary|Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1228251|NCT00678301|Secondary|Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes|Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titres||95% Confidence Interval|Geometric Mean
1228333|NCT00677820|Primary|Number of Subjects Reporting Fever|Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.|Days 0-7|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
1228252|NCT00678301|Secondary|Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1228253|NCT00678301|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1228254|NCT00678301|Primary|Antibody Concentrations Against Protein D (Anti-PD Antibodies)|Anti-PD antibody concentrations were expressed in enzyme-linked immunorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1228255|NCT00678301|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1228256|NCT00678288|Secondary|Overall Survival|Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
1228257|NCT00678288|Secondary|Duration of Response|Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
1228258|NCT00678288|Secondary|Time to Progression|Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
1228259|NCT00678288|Secondary|Response Rate|Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
1228260|NCT00678288|Primary|Progression-Free Survival|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|From start of treatment of the first subject until 14 months later, assessed every 8 weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
1228261|NCT00678249|Secondary|Percent of Participants With Binary Restenosis|Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window (or the core lab could not assess the angiogram), then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
1228262|NCT00678249|Secondary|Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)|ACCP defined as patency (open to blood flow) following the index study procedure until the access is surgically revised or abandoned because of the inability to treat the original lesion. Multiple treatments for occlusions to restore patency are compatible with ACCP.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
1228263|NCT00678249|Secondary|Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)|ACAPP defined as patency (open to blood flow)following the index study procedure until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
1228265|NCT00678249|Secondary|Percent of Participants With TAPP|TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.|2 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
1228266|NCT00678249|Secondary|Percent of Participants With Procedural Success|Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success|Index Procedure||||Percentage of Participants|||Number
1228267|NCT00678249|Secondary|Percent of Participants With Successful Delivery of the Device|The ability to successfully deliver the FLAIR™ Endovascular Stent Graft. Successful delivery is the ability to deliver and seat the implant in the intended location of a stenosed segment of the venous anastomosis region of a synthetic access graft. This attribute is only applicable to the FLAIR and FLAIR Roll-in arms.|Index Procedure|The PTA Only group was not analyzed for this outcome measure because it is for successful delivery of the FLAIR study device (PTA Only is the control arm).|||Percentage of Participants|||Number
1228268|NCT00678249|Secondary|Total Number of Adverse Events|The safety endpoint was evaluated based on the incidence of adverse events observed within the same time interval. An adverse event was defined as any undesirable clinical occurrence in a patient that (a) is considered possibly or definietly device related by the investigator, (b) involves the access circuit (AV graft arterial anastomosis to the superior vena cava-right atrial junction) or the arm where the access circuit is located or (c) the investigator considers relevant to the objectives of this study. An adverse event could be mild, moderate or severe.|6 month Follow-Up||||total events|||Number
1228269|NCT00678249|Primary|Percent of Participants With Treatment Area Primary Patency (TAPP)|TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.|6 month follow-up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
1228270|NCT00678210|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Baseline, Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.|||units on a scale||Standard Error|Mean
1228271|NCT00678210|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores and Total Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Baseline, Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.|||units on a scale||Standard Error|Mean
1228272|NCT00678210|Secondary|Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 12|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF.|||percentage of participants|||Number
1228273|NCT00678210|Secondary|Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.|||percentage of participants|||Number
1228291|NCT00678041|Secondary|Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.|0 participants analyzed due to study termination.Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
1228274|NCT00678210|Secondary|Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 2, 4, 8, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.|||percentage of participants|||Number
1228275|NCT00678210|Secondary|Percentage of Participants Achieving Physician’s Global Assessment (PGA) Score of “Clear” or “Almost Clear”|Physician global assessment of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the whole body according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. The score of 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.|||percentage of participants|||Number
1228276|NCT00678210|Primary|Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
1228277|NCT00678080|Primary|The Number of Participants Who Achieved a Hemoglobin A1C <7%|The hemoglobin A1c level is an indicator of glycemic control—it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.|at the time of delivery|At the time of delivery, hemoglobin A1c levels were obtained for only 5 in the metformin arm and 8 in the insulin arm.|||Participants|||Count of Participants
1228278|NCT00678080|Secondary|Number of Participants With Newborns Who Needed Neonatal Dextrose||Neonatal period||||Participants|||Count of Participants
1228279|NCT00678080|Secondary|Number of Participants Who Had a Newborn With Respiratory Distress Syndrome||Neonatal period||||Participants|||Count of Participants
1228280|NCT00678080|Secondary|Number of Participants With Shoulder Dystocia||At the time of delivery||||Participants|||Count of Participants
1228281|NCT00678080|Secondary|Number of Participants With Fetus With Macrosomia||At the time of delivery||||Participants|||Count of Participants
1228282|NCT00678080|Secondary|Number of Participants Who Had a Cesarean Section||At the time of delivery||||Participants|||Count of Participants
1228283|NCT00678080|Secondary|Number of Participants Who Failed Metformin Therapy|Those whose glucose levels were above target range thereby needing insulin therapy|Duration of pregnancy||||Participants|||Count of Participants
1228284|NCT00678080|Secondary|Number of Participants With Hypoglycemia|Defined as hypoglycemia as documented by neonatal chart based on health care provider description|During pregnancy||||Participants|||Count of Participants
1228285|NCT00678080|Secondary|Body Mass Index||at the time of delivery||||kg/m^2||Standard Deviation|Mean
1228286|NCT00678080|Primary|The Number of Participants Who Achieved a Hemoglobin A1C <7%|The hemoglobin A1c level is an indicator of glycemic control—it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.|during third trimester|During the third trimester, hemoglobin A1c levels were obtained for only 5 in the metformin arm and 12 in the insulin arm.|||Participants|||Count of Participants
1228287|NCT00678041|Secondary|Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
1228288|NCT00678041|Secondary|Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
1228289|NCT00678041|Secondary|Patient Perceptions Regarding CISC|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|||||||
1228290|NCT00678041|Secondary|Adherence to CISC|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
1234213|NCT00627393|Secondary|Discontinuation of Granulocyte Transfusions Due to Toxicity or Intolerance||Measured through Day 42|||||||
1228292|NCT00678041|Secondary|Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
1228293|NCT00678041|Primary|Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation|Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.|6 to 8 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
1228294|NCT00678015|Post-Hoc|Disease Progression at End of Study|End-of-study imaging was assessed for disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Progressive Disease (PD)=At least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline, End of treatment (2-19 cycles)|At the time of calculation, 1 patient was still on study after 29 cycles|||participants|||Number
1228295|NCT00678015|Post-Hoc|Change in Prostate Specific Antigen Doubling Time (PSADT)|PSADT was calculated using the formula natural log 2 divided by the slope of the natural log of the PSA versus time. Pretreatment PSADT was calculated using a minimum of 3 values; end of study PSADT incorporated all measured PSA values on study starting Cycle 2-Day 1 until the patient was removed from the study.|Cycle 2 through end of treatment (up to 29 months)|At the time of PSADT calculations, one participant was still on study at 29 months, and 11 participants' time on study had ranged from 2-19 months|||percentage change||Full Range|Median
1228296|NCT00678015|Post-Hoc|PSA Decline|Number of participants experiencing PSA decline during the first 3 treatment cycles|Baseline; Monthly, up to 29 months after beginning treatment||||participants|||Number
1228297|NCT00678015|Primary|Prostate Specific Antigen (PSA) Response According to Consensus Criteria|Participants who experienced a PSA decline of at least 50%, confirmed by a second PSA value 4 or more weeks later. The reference PSA for decline was a PSA measured within 2 weeks of beginning study treatment. If at most 1 PSA response was observed among the first 12 patients, then accrual would stop and the trial would close for futility.|Monthly, up to 29 months||||participants|||Number
1228298|NCT00677924|Secondary|Best Overall Response|Best overall response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16|Overall Study||||Participants|||Number
1228299|NCT00677924|Primary|Adverse Events|Number of patients experiencing an adverse event|Overall Study|Number of patients experiencing an adverse event|||participants|||Number
1228300|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides|Guidelines recommend that triglycerides be evaluated every 2 years|1 year||||percentage of days in the study period||Standard Deviation|Mean
1228301|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol|Guidelines recommend that HDL cholesterol be evaluated every 2 years|1 year||||percentage of days in study period||Standard Deviation|Mean
1228302|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol|Guidelines recommend that LDL cholesterol be evaluated every 2 years|1 year||||percentage of days in study period||Standard Deviation|Mean
1228303|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Glucose/HbA1c|Guidelines recommend that blood glucose/HbA1c be evaluated every year|1 year||||percentage of days in the study period||Standard Deviation|Mean
1228304|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure|Guidelines recommend that blood pressure be evaluated every 3 months|1 year||||percentage of days in the study period||Standard Deviation|Mean
1228305|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Body Mass Index|Guidelines recommend that body mass index be evaluated every 3 months|1 year||||percentage of days in the study period||Standard Deviation|Mean
1228306|NCT00677833|Secondary|Percentage of Participants With PfCRT in True Failures|A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.|Baseline to Day 42|Data for this outcome measure was not analyzed as per change in planned analysis.||||||
1228307|NCT00677833|Secondary|Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status||Baseline to Day 42|Data for this outcome measure was not analyzed as per change in planned analysis.||||||
1228308|NCT00677833|Secondary|Time to Recurrence of Parasitemia|Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).|Baseline (Day 0) to Day 42|mITT population, including participants in the Ivory Coast center.|||Days||Full Range|Median
1228309|NCT00677833|Secondary|Change From Nadir Hemoglobin Level at Days 14, 28, and 42|Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.|Day 14, 28, 42|"mITT population. N = number of participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."|||g/dL||Standard Error|Mean
1228311|NCT00677833|Secondary|Asexual Plasmodium Falciparum Parasite Clearance Time|Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Baseline to Day 42|mITT population, including participants in the Ivory Coast center.|||Hours||Full Range|Median
1228312|NCT00677833|Secondary|Fever Clearance Time|Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral).|Baseline to Day 42|mITT population, including participants in the Ivory Coast center.|||Hours||Full Range|Median
1228313|NCT00677833|Secondary|Percentage of Participants With Gametocytologic Response|Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|"mITT population. N= participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."|||Percentage of participants|||Number
1228314|NCT00677833|Secondary|Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)|Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 7, 14, 21, 28, 35, 42|"mITT population. Number of participants analyzed (N)=participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."|||Percentage of participants|||Number
1228315|NCT00677833|Secondary|Percentage of Participants With LPF in PP Population (PCR-corrected)|LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 28, 35, 42|PP population, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants|||Number
1228316|NCT00677833|Secondary|Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)|LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 28, 35, 42|mITT population, participants in Ivory Coast center were excluded from mITT population.|||Percentage of participants|||Number
1228317|NCT00677833|Secondary|Percentage of Participants With LCF in PP Population (PCR-corrected)|"LCF included participants who met any of the following criteria:~Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)~Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Days 7, 14, 21, 28, 35, 42|PP population, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants|||Number
1228318|NCT00677833|Secondary|Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)|"LCF included participants who met any of the following criteria:~Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)~Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Days 7, 14, 21, 28, 35, 42|mITT population, participants in Ivory Coast center were excluded from mITT population.|||Percentage of participants|||Number
1228319|NCT00677833|Secondary|Percentage of Participants With ETF in PP Population (PCR-corrected)|"ETF defined as participants who met the following criteria:~Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia~Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.~Parasitemia (P.falciparum) on Day 3 with fever or~Last available P.falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).~PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Day 0 up to Day 3|PP population, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants|||Number
1228320|NCT00677833|Secondary|Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)|"ETF defined as participants who met the following criteria:~Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia~Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.~Parasitemia (P. falciparum) on Day 3 with fever or~Last available P. falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).~PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Day 0 up to Day 3|mITT population, participants in Ivory Coast center were excluded from mITT population.|||Percentage of participants|||Number
1228321|NCT00677833|Secondary|Percentage of Participants With PCR-uncorrected ACPR in PP Population|ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants||95% Confidence Interval|Number
1228322|NCT00677833|Secondary|Percentage of Participants With PCR-uncorrected ACPR in the mITT Population|ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population.|||Percentage of participants||95% Confidence Interval|Number
1228323|NCT00677833|Secondary|Percentage of Participants With PCR-corrected ACPR in PP Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 35, 42|PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants||95% Confidence Interval|Number
1228324|NCT00677833|Secondary|Percentage of Participants With PCR-corrected ACPR in the mITT Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 35, 42|mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population.|||Percentage of participants||95% Confidence Interval|Number
1228325|NCT00677833|Primary|Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 28|Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population.|||Percentage of participants||95% Confidence Interval|Number
1228326|NCT00677833|Primary|Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population|ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures [LCF] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)– see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 28|mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter [mcL];fever/history of fever >=38 degree Celsius[C] [rectal],37.2 degree C [axillary] or >=37.5 degree C [oral] within last 24 hours).Participants in Ivory Coast center excluded from analysis.|||Percentage of participants||95% Confidence Interval|Number
1228327|NCT00677820|Secondary|Number of Subjects Reporting SAEs and SNMCs|"SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.~An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant."|Days 0-180|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
1228328|NCT00677820|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)|"SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.~An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant."|Days 0-28|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
1228334|NCT00677807|Secondary|Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52|"The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates.~SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant."|Weeks 36, 44 and 52|"Extension Intent-to-treat population consisting of all participants who received at least one dose of study drug. n in each of the categories is the number of participants with data at the given time point. Missing data were imputed using LOCF but not by more than 14 weeks and not by carrying forward scores within 4 weeks of treatment start."|||Score on a Scale||Standard Error|Least Squares Mean
1228335|NCT00677807|Primary|Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52|The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.|Weeks 12, 26, 36, 44 and 52|"Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment."|||mmol/L||Standard Error|Least Squares Mean
1228336|NCT00677807|Primary|Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52|The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.|Weeks 12, 26, 36, 44 and 52|"Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment."|||mmol/L||Standard Error|Least Squares Mean
1228337|NCT00677807|Primary|The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.~The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).~Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.|||participant|||Number
1228338|NCT00677807|Primary|The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.~A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.|||participants|||Number
1228339|NCT00677807|Primary|The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.~A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.|||participants|||Number
1228340|NCT00677807|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.|Week 52|Participants from the Extension Intent-to-treat population (consisting of all participants who received at least one dose of study drug) for whom data was available for this Outcome Measure. Missing data was imputed Last Observation Carried Forward.|||Liters||Standard Error|Least Squares Mean
1228341|NCT00677807|Primary|The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment.~Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm.~High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.|||Participants|||Number
1228342|NCT00677690|Secondary|Respiratory Function|forced expiratory volume in 1 second (FEV1)|5 weeks||||percentage of predicted value||Standard Deviation|Mean
1228343|NCT00677690|Primary|Quadriceps Strength|Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.|5 weeks||||repetitions||Standard Deviation|Mean
1228344|NCT00677690|Secondary|Quality of Life|St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).|5 weeks||||units on a scale||Standard Deviation|Mean
1228345|NCT00677690|Primary|Exercise Capacity|6 minute walk test(6MWT)|5 weeks||||meters||Standard Deviation|Mean
1228346|NCT00677690|Secondary|Dyspnoea|The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.|5 weeks||||units on a scale||Standard Deviation|Mean
1228347|NCT00677534|Primary|Change in Monocyte VDR Expression With Vitamin D Therapy|Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.|Change from End of Washout to Week 12|Clinical pilot trial - proof of concept|||units on a scale||Standard Deviation|Mean
1228348|NCT00677365|Secondary|Changes in Susceptability Patterns of Isolated Organisms|All isolates of P. aeruginosa cultures grown from patient sputum samples were evaluated to see whether the minimum concentration of levofloxacin needed to inhibit growth of the bacteria (i.e., minimum inhibitory concentration; MIC) had increased; 2. The MIC50 and MIC90 values were calculated as the 50th percentile value and the 90th percentile value, respectively. Note that percentile values between dilution values were rounded up to the nearest dilution value|from baseline until the end of the 28-day treatment period (28 days)|MITT|||ug/mL|Isolates||Number
1228349|NCT00677365|Secondary|Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)|Change in the score from 0 to 100 that a patient reports for their respiratory symptoms in the CFQ-R. An increase in score illustrates an improvement in symptoms. An increase of 4 or more is considered clinically significant|from baseline to the end of the 28-day treatment period (28 days)|MITT|||units on a scale||Standard Error|Least Squares Mean
1228350|NCT00677365|Secondary|Change in FEV1 Percent Predicted|Change in the predicted percent of air the patient could exhale in one second|from baseline to the end of the treatment 28-day treatment period (28 days)|MITT|||Percent||Standard Error|Least Squares Mean
1228351|NCT00677365|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|Percent change in the amount of air the patient could exhale in 1 second|from baseline to end of the 28-day treatment period (28 days)|MITT|||Percent change||Standard Error|Least Squares Mean
1228352|NCT00677365|Secondary|Time to Administration of Other Anti-pseudomonal Antimicrobials|Time to administration of other anti-pseudomonal antimicrobials in patients with at least one of the following: decreased exercise tolerance, increased cough, increased sputum/chest congestion, or decreased appetite; 25th percentile data reported|from baseline until final study visit (up to 56 days)|MITT|||days||95% Confidence Interval|Mean
1228353|NCT00677365|Primary|Change in P. Aeruginosa Density|Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period|from baseline to end of treatment (28 days)|Modified Intent-to-Treat (MITT; patients who received at least one dose of study drug)|||log10 CFU/g sputum||Standard Error|Least Squares Mean
1228354|NCT00677352|Secondary|Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase|The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group.|4 weeks|Completer Set : Subset of patients in the EES who had a PAS rating at Week 16.|||Percentage of participants|||Number
1228355|NCT00677352|Secondary|Summary of Adverse Events in Tapering Phase|Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row.|4 weeks|The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.|||Participants|||Number
1228356|NCT00677352|Secondary|Number of Participants With Summary of Adverse Events in Treatment Phase|Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row.|1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug|The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.|||Participants|||Number
1228357|NCT00677352|Secondary|Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase|"The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items.~The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52."|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"|||Scores on a scale||Standard Deviation|Mean
1228358|NCT00677352|Secondary|Mean Change From Baseline in Panic Attack at the End of Treatment Phase|Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills.|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"|||panic attacks per week||Standard Deviation|Mean
1228374|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 12 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|12 months||||proportion of participants||95% Confidence Interval|Number
1228359|NCT00677352|Secondary|Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement|"The ratings were rated to compare with baseline by 7-point  1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.~Responder was defined as number of participants who were assessed as very much improved or  much improved."|12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"|||Percentage of participants|||Number
1228360|NCT00677352|Primary|Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase|Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology.|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"|||Scores on scale||95% Confidence Interval|Least Squares Mean
1228361|NCT00677235|Post-Hoc|Treatment Area Primary Patency (TAPP) at 24 Months.|TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.|24 months follow-up||||proportion of participants||95% Confidence Interval|Number
1228362|NCT00677235|Post-Hoc|Treatment Area Primary Patency (TAPP) at 12 Months.|TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.|12 months follow up||||proportion of participants||95% Confidence Interval|Number
1228363|NCT00677235|Secondary|Post-intervention Secondary Patency at 6 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|6 month follow-up||||proportion of participants||95% Confidence Interval|Number
1228364|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 6 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|6 month follow up||||proportion of participants||95% Confidence Interval|Number
1228365|NCT00677235|Secondary|Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.|The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.|24 months|All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.|||Months/intervention||Standard Deviation|Least Squares Mean
1228366|NCT00677235|Secondary|Post-intervention Secondary Patency at 24 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|24 months||||proportion of participants||95% Confidence Interval|Number
1228367|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 24 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|24 month follow up||||proportion of participants||95% Confidence Interval|Number
1228368|NCT00677235|Secondary|To Estimate Safety at 24 Months.|To estimate the percentage of participants without safety issues through 24 months.|24 months||||percentage of participants|||Number
1228369|NCT00677235|Secondary|Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.|Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.|24 months|All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).|||proportion of participants||95% Confidence Interval|Number
1228370|NCT00677235|Secondary|Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months|Serious Adverse Events at 12 months are reported for all 270 subjects.|12 months||||percentage of participants with serious|||Number
1228371|NCT00677235|Secondary|Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure|The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the Bard Peripheral Vascular (BPV) clinician training program.|Patient Follow-Up||||events|||Number
1228372|NCT00677235|Secondary|Procedural Success|Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.|Patient Follow-Up||||Percentage of Participants|||Number
1228373|NCT00677235|Secondary|Post-intervention Secondary Patency (PSP) at 12 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|12 months||||proportion of participants||95% Confidence Interval|Number
1228375|NCT00677235|Secondary|To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure|The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|Patient Follow-Up||||reinterventions||Standard Deviation|Mean
1228376|NCT00677235|Primary|The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.||12 months||||Number of Participants with Device and/o|||Number
1228377|NCT00677235|Primary|The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.|The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.|12 months|All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.|||Months/intervention||Standard Deviation|Least Squares Mean
1228378|NCT00677235|Primary|ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.|To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.|12 months|All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).|||proportion of participants||95% Confidence Interval|Number
1228379|NCT00677092|Secondary|Change From Baseline in Short Form 36 (SF-36) Score||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
1228380|NCT00677092|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
1228381|NCT00677092|Secondary|Change From Baseline in Visual Analog Scale (VAS) for Pain||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
1228382|NCT00677092|Secondary|Change From Baseline in Histologic Appearance of Skin Biopsy||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
1228383|NCT00677092|Secondary|Change From Baseline in Maximal Extension of Elbows and Knees||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
1228384|NCT00677092|Primary|Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering|The modified Rodnan Skin Score is the accepted clinical measure of scleroderma skin activity. The investigator assessed the thickening of the skin using the modified Rodnan Skin Score through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness was assessed on a scale of 0 to 3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0 (normal) to 51 (severe thickening in all 17 areas). Percentage change is calculated as the Month 4 Score - Baseline Score/Baseline Score * 100. A negative percentage change indicates improvement.|Baseline and Month 4|All enrolled participants with Baseline and Month 4 data available for analysis.|||percentage change in mRSS score||Standard Deviation|Mean
1228385|NCT00677040|Secondary|Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured.||One visit||||Participants|||Count of Participants
1228386|NCT00677040|Primary|Tissue Oxygenation|Transcutaneous oxygen detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area.|One visit for 20 minutes||||mmHg||Standard Deviation|Mean
1228387|NCT00677014|Secondary|Secondary Endpoints Will Include Structural and Functional Measures||Chronic|||||||
1228388|NCT00677014|Primary|Left Ventricular End-systolic Volume (LVESV)|Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up|6 months|Availability of baseline and 6 month echocardiograms with primary endpoint values (LVESV) among randomized patients|||ml||Inter-Quartile Range|Median
1228389|NCT00676897|Secondary|Inflammatory Marker Levels|Change in inflammatory marker levels over time from time zero to time 24 hour.|over 24 hours (time zero and time 24 hours)||||pg/mL and ng/mL||Standard Deviation|Mean
1228390|NCT00676897|Primary|Time to Shock Reversal||up to 7 days||||hours||Standard Deviation|Mean
1228391|NCT00676806|Secondary|Compare Rates of Complications Between Patients Receiving Ablative vs. Non-myeloablative Conditioning Prior to UCB Transplantation|Composite endpoint of GVH or infection. Too few events to compare between arms.|+180 days||||events|||Number
1228392|NCT00676806|Secondary|Incidence of Chronic GVHD||After Day +100|No subject receiving reduced intensity conditioning was evaluable for the event of chronic GVHD (0/3 subjects survived to day +100)|||participants|||Number
1228393|NCT00676806|Secondary|Infectious Complications in UCB Recipients.||Day +100||||participants|||Number
1228394|NCT00676806|Secondary|Incidence of Acute GVHD||Day +100||||participants|||Number
1228395|NCT00676806|Secondary|Proportion of Subjects With Platelet Engraftment|Proportion of patients engrafting by days +45, +90, and +180.|+45, 90, and 180 days||||participants|||Number
1228396|NCT00676806|Primary|Number of Participants With Neutrophil Engraftment|Number of participants with neutrophil engraftment receiving umbilical cord blood for hematopoietic rescue following myeloablative or non-myeloablative conditioning|+45 and 90 days|Only 2 subjects were evaluable from each group at the +45 day mark. The same number were evaluable at the +90 day mark.|||participants|||Number
1228397|NCT00676793|Primary|Change in Serum HGF and Breast Cancer|Change in serum HGF from baseline to post Polyphenol E treatment.|Baseline and 4 to 6 weeks|Number of participants for analysis was determined per protocol.|||pg/ml||Inter-Quartile Range|Median
1228399|NCT00676780|Primary|Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.|Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks|Number of participants for analysis was determined per protocol.|||pg/mL||Inter-Quartile Range|Median
1228400|NCT00676780|Primary|Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.|Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks.|The number of participants for analysis was determined per protocol.|||pg/mL||Inter-Quartile Range|Median
1228401|NCT00676780|Primary|Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer|Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks|The number of participants for analysis was determined per protocol.|||ng/mL||Inter-Quartile Range|Median
1228402|NCT00676715|Secondary|Total Number of Gadolinium-Enhancing T1 Lesions at Weeks|Total number of gadolinium-enhancing T1 lesions at weeks were reported.|Weeks 4 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.|||Lesions||Standard Deviation|Mean
1228403|NCT00676715|Secondary|Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain|Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.|Weeks 4 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.|||Lesions||Standard Deviation|Mean
1228404|NCT00676715|Secondary|Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24|Change from baseline in total volume of T2 lesions on MRI scans of the Brain at week 24 was reported.|Baseline, Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, n signifies the number of participants evaluated at specified time points.|||Cubic Millimeter (mm^3)||Standard Deviation|Mean
1228405|NCT00676715|Secondary|Percentage of Participants Who Remained Relapse Free at Week 24|Percentage of participants who remained relapse free at week 24 were reported.|Week 24|The intent-to-treat population includes all randomized participants who had received any study drug.|||percentage of participants||95% Confidence Interval|Number
1228406|NCT00676715|Secondary|Annualized Protocol Defined Relapse Rate at Week 24|Adjusted annualized relapse rate for geographical region.|Week 24|The intent-to-treat population includes all randomized participants who had received any study drug.|||Number of relapses||95% Confidence Interval|Number
1228407|NCT00676715|Primary|Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain|Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.|Week 12 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.|||Lesion||Standard Deviation|Mean
1228408|NCT00676689|Secondary|Functional Improvement|"Functional improvement at 6 months as defined by:~a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis."|6 months|Valve implant population. There were 2 screen failure patients and 10 patients where procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population. There were 11 additional patients for which data was not available for analysis, leaving 58 patients in this analysis.|||participants|||Number
1228409|NCT00676689|Secondary|Freedom From MACCE|Clinical Events Committee (CEC) adjudicated.|6 Months|Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.|||percentage of participants||95% Confidence Interval|Number
1228410|NCT00676689|Primary|Freedom From Device or Procedure Related Death or Reintervention||1 year|Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.|||percentage of participants||95% Confidence Interval|Number
1228411|NCT00676676|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Scale|the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).|Baseline, 2-week, 8-week|This was a pilot protocol|||units on a scale||Standard Deviation|Mean
1228412|NCT00676650|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction."|Baseline, every 4 weeks up to 123 weeks|Data not summarized, study terminated early||||||
1228413|NCT00676650|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)|FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.|Baseline, every 4 weeks up to 123 weeks|Data not summarized, study terminated early||||||
1228414|NCT00676650|Secondary|Change From Baseline in Pain Severity|Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.|Day 1 through Day 7 every 28 days (every cycle) up to 29 months|Data not summarized, study terminated early||||||
1228415|NCT00676650|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response|Baseline, every 8 weeks up to 123 weeks|Data not summarized, study terminated early||||||
1228416|NCT00676650|Secondary|Percent of Participants With Objective Response (OR)|OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.|Baseline, every 8 weeks up to 123 weeks|FA Population|||percentage of participants||95% Confidence Interval|Number
1228417|NCT00676650|Secondary|Progression-Free Survival (PFS)|PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02|Baseline, every 8 weeks up to 123 weeks|FA Population|||weeks||95% Confidence Interval|Median
1228418|NCT00676650|Primary|Overall Survival (OS)|OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.|Baseline up to 32 months|Full analysis (FA) population: all participants who were randomized, with study drug assignment designated according to initial randomization, regaradless of whether participant received study drug according to the randomization schedule.|||months||95% Confidence Interval|Median
1228419|NCT00676585|Secondary|Sub-group Analysis of Patients With Adrenal Insufficiency|Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL|At time of enrollment|There were 9 patients identified with baseline absolute cortisol deficiency (3 in the control arm and 6 in the intervention arm). This sub population of study participants were analyzed for shock reversal, good neurological outcomes, and survival as shown in each row of the table below.|||Participants|||Count of Participants
1228420|NCT00676585|Secondary|Mortality||Length of hospital stay, an average of 9 days with a maximum of 36 days||||Participants|||Count of Participants
1228421|NCT00676585|Primary|Time to Shock Reversal|The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.|7 Days||||hours||Inter-Quartile Range|Median
1228422|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|1 year|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
1228423|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|180 days|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
1228424|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at baseline|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
1228446|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228425|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at 1 year|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
1228426|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at 180 days|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
1228427|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at baseline|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
1228428|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228429|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228430|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228431|NCT00676520|Secondary|Dual Antiplatelet Therapy Non-compliance Through 1 Year|Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.|1 year|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
1228432|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 1 year|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
1228433|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 180 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
1228434|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 30 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
1228435|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 14 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
1228436|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228437|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228438|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228439|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 14 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228440|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228441|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228442|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228443|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228444|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228445|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228447|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228448|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228449|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228450|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228451|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228452|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228453|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228454|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228455|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228456|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228457|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228458|NCT00676520|Secondary|Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228459|NCT00676520|Secondary|Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228460|NCT00676520|Secondary|Procedural Success||acute: post index procedure until hospital discharge|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants||95% Confidence Interval|Number
1228461|NCT00676520|Secondary|Clinical Device Success||acute: post index procedure until hospital discharge|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of lesions|Participants|95% Confidence Interval|Number
1228462|NCT00676520|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)|MI= ARC (Academic Research Constortium) defined|1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228463|NCT00676520|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).|"ARC Defines Stent Thrombosis in the following way:~Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria:~Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers~Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause~Possible Stent Thrombosis Any unexplained death beyond 30 days~For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1"|up to 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
1228464|NCT00676494|Primary|Major Adverse Events (MAEs) Within 30 Days|Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.|30 days|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.|||Participants|||Number
1228465|NCT00676494|Secondary|Freedom From Target Lesion Revascularization (TLR) at 6 Months|Number of patients that did not require target lesion revascularization 6 months after index procedure.|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.|||participants|||Number
1228466|NCT00676494|Secondary|Average Ankle Brachial Index (ABI) at 6 Months|Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.|||units on scale||Standard Deviation|Mean
1228467|NCT00676494|Secondary|Average Rutherford Classification Score at 6 Months|Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.|||Score on scale||Standard Deviation|Mean
1228468|NCT00676455|Secondary|Tumor Size Will be Measured by CT (by the MeVis Volumetry Software and Correlated With On-going Treatment Plan.|"Tumor size will be measured by CT (by the MeVis Volumetry Software and correlated with on-going treatment plan.~Correlation of the tumor growth with clinical treatment will be assessed. Tumor size will be expressed in volume. Specifically Three dimensional volume Volume of Interest(VOI)will be calculated and correlated with the treatment protocol. Measure = tumor volume."|As long as treatment is being assessed by CT examinations|Due to low enrollment no analysis was conducted due to the lack of participants.||||||
1228469|NCT00676455|Primary|This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions|"Due to the low enrollment for this project the data collected is not sufficient to provide any significant conclusion to the primary outcome hypothesis.~Due to lack of participants. No significant findings are reported at this time."|As long as treatment is being assessed by CT examinations|Due to low enrollment no analysis was conducted due to the lack of participants.||||||
1228470|NCT00676403|Secondary|Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores|"Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from much worse now to much better now. Recall period: month prior to the assessment."|Baseline, Week 6|ITT; N = number of subjects in a treatment group.|||participants|||Number
1228502|NCT00676338|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to Week 26.|Baseline, Week 26|Intent to treat (ITT) population consisted of all randomized patients who had taken at least one dose of study drug. All scheduled post-baseline measurements were included in the analysis. Unscheduled visit observations were carried forward to the next scheduled visits.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1228471|NCT00676403|Secondary|Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, had baseline and post-baseline values.|||scores on scale||Standard Error|Least Squares Mean
1228472|NCT00676403|Secondary|Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6|RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, and had baseline and post-baseline values.|||scores on scales||Standard Error|Least Squares Mean
1228473|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.|Week 1, Week 2, Week 4, Week 6|ITT|||participants|||Number
1228474|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228475|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228476|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.|Baseline,, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228477|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.|Baseline,, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228478|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228479|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228480|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228481|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT, Baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228482|NCT00676403|Secondary|Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
1228483|NCT00676403|Secondary|Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.|||minutes||Standard Error|Least Squares Mean
1228484|NCT00676403|Secondary|Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit.|||awakenings||Standard Error|Least Squares Mean
1228485|NCT00676403|Secondary|Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.|||hours||Standard Error|Least Squares Mean
1228486|NCT00676403|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||minutes||Standard Error|Least Squares Mean
1228487|NCT00676403|Secondary|Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)|CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)|ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward.|||participants|||Number
1228488|NCT00676403|Secondary|Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)|Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.|Week 6|ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating.|||participants|||Number
1228489|NCT00676403|Primary|Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6|IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment.|||scores on scale||Standard Error|Least Squares Mean
1234214|NCT00627393|Secondary|Evaluation of Granulocyte Yield||Measured immediately after each granulocyte donation||||Granulocyte Yield (billion cells/liter)|Participants|Inter-Quartile Range|Median
1228490|NCT00676364|Primary|Pain From Venipuncture|"Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. FACES in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain."|Pain was measured immediately after venipuncture.|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|||scores on a scale||Standard Deviation|Mean
1228491|NCT00676364|Secondary|Anxiety of Venipuncture|Participant anxiety was measured by the study participant and the objective observer before (anticipatory), during (venipuncture) and after (recovery) venipuncture using a validated visual analog scale (VAS). The VAS is a validated scale that is used to detect small changes in many types of observations. The scale ranges from 0-100 scores on a scale, and here the higher scores indicate higher anxiety levels. Only the participant's mean venipuncture (during venipuncture) anxiety scores are presented in outcome measure results here.|During venipuncture|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|||scores on a scale||Standard Deviation|Mean
1228492|NCT00676338|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26.|Change in Diastolic Blood Pressure from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmHg||Standard Error|Least Squares Mean
1228493|NCT00676338|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26.|Change in Systolic Blood Pressure from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmHg||Standard Error|Least Squares Mean
1228494|NCT00676338|Secondary|Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events|Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 26|ITT population.|||events per subject-year||Standard Error|Mean
1228495|NCT00676338|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 26|ITT population.|||events per subject-year||Standard Error|Mean
1228496|NCT00676338|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
1228497|NCT00676338|Secondary|Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26|Change in Fasting HDL from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmol/L||Standard Error|Least Squares Mean
1228498|NCT00676338|Secondary|Change in Fasting Total Cholesterol (TC) From Baseline to Week 26|Change in Fasting TC from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmol/L||Standard Error|Least Squares Mean
1228499|NCT00676338|Secondary|Change in Body Weight From Baseline to Week 26|Change in Body Weight from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||kg||Standard Error|Least Squares Mean
1228500|NCT00676338|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmol/L||Standard Error|Least Squares Mean
1228501|NCT00676338|Primary|Percentage of Patients Achieving HbA1c <=7% at Week 26|Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with baseline HbA1c >7%).|Baseline, Week 26|ITT subjects with baseline HbA1c>7%. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.|||percentage of patients|||Number
1228503|NCT00676208|Secondary|Change in Professionals' Attitudes About Diabetes|The University of Michigan's Research and Training Center's Diabetes Attitude Scale was used. There are 33 items and the response format is a 5 point Likert Scale ranging from 'strongly disagree'(1) to 'strongly agree'(5). A higher score means more positive attitudes toward diabetes and its treatment (e.g., psychosocial impact of diabetes; value of tight glucose control).The total score is computed by summing individual items and ranges from 0 to 165. Post-pre total scores were used with positive and higher values indicating greater favorable change.|Pre-intervention and Post-intervention at 1 month||||units on a scale||Standard Deviation|Mean
1228504|NCT00676208|Primary|Change in Confidence in Ability to Perform Teamwork|A three item scale was used to assess confidence in ability to convey logic of recommendations to other providers, explain one's distinctive perspective, and be accountable to patients for a decision made by a colleague from another discipline. The responses for each item ranged from 'not at all confident' (0) to 'very confident' (4), with higher values indicating more confidence. The total scale ranged from 0 to 16 with higher being more confident. Difference scores were analyzed (post-pre) with positive and higher values indicating more favorable change.|Pre-intervention and Post-Intervention at 1 month||||units of a scale||Standard Deviation|Mean
1228505|NCT00676195|Secondary|Glutathione Metabolism Intermediates in Peripheral Blood Measured by High-performance Liquid Chromatography||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.||||||
1228506|NCT00676195|Secondary|Irritability Subscale of the Aberrant Behavior Checklist (ABC)||4, 8, and 12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.||||||
1228507|NCT00676195|Secondary|Sensory Profile Questionnaire (SPQ)||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.||||||
1228508|NCT00676195|Secondary|Social Responsiveness Scale (SRS)||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.||||||
1228509|NCT00676195|Primary|Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES)|Number of Participants with adverse events reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES) during the course of the study as measured at time points (4, 8, and 12 weeks).|4, 8, and 12 weeks||||number of participants|||Number
1228510|NCT00676182|Primary|Beck Depression Inventory Score (Total Score)|Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.|||units on a scale||Standard Deviation|Mean
1228511|NCT00676182|Primary|Alcohol Use Disorders Identification Test (AUDIT) (Total Score)|Range for Total Score: 0-40 Directionality: Higher score means more alcohol use.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.|||units on a scale||Standard Deviation|Mean
1228512|NCT00676182|Primary|Modified PTSD Symptom Scale: Self-Report - Severity|Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.|||units on a scale||Standard Deviation|Mean
1228513|NCT00676182|Primary|Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)|Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.|Baseline, 6 Months, 12 Months|Veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.|||units on a scale||Standard Deviation|Mean
1228514|NCT00676182|Primary|PTSD Checklist Military Form (PCL-M) (Total Score)|Range for total score: 17- 85 Directionality for total score: Higher score means experiencing more PTSD-related problems.|Baseline, 6 Months, 12 Months|Veterans with TBI with comorbid PTSD who were analyzed at the specified time point.|||units on a scale||Standard Deviation|Mean
1228515|NCT00676182|Primary|Patient Competency Rating Scale (PCRS) (Total Score)|Range for total score: 30 - 150 Directionality for total score: higher score means higher competency (can do things with greater ease)|Baseline, 6 Months, 12 Months|Only participants with data at the specified time were analyzed.|||units on a scale||Standard Deviation|Mean
1228516|NCT00676182|Primary|Craig Handicap Assessment and Reporting Technique (CHART)|"Ranges for Subscales: 0 - 100 Physical Independence: 4 -100 Cognitive Independence: 0 -100 Mobility: 0 -100 Occupation: 0 -100 Social Integration: 0 -100 Economic Self Sufficiency: 0-100~Directionality: for each subscale, higher score means more independence; lower score means needs more assistance."|Baseline, 6 Months, 12 Months|Only participants with data at the specified time points were analyzed.|||units on a scale||Standard Deviation|Mean
1228517|NCT00676182|Primary|Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)|Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.|Baseline, 6 months, 12 months|Only participants with data at the specified time points are included in the analysis.|||units on a scale||Standard Deviation|Mean
1228518|NCT00676143|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78|The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units on a scale||Standard Error|Least Squares Mean
1228519|NCT00676143|Secondary|Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participant|||Number
1228520|NCT00676143|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score of ≤ 0, ≤ 6, and ≤ 12 points. In order to calculate time to first median placebo deterioration in DAD, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining “deterioration” for Alzheimer’s disease participants in the study. If the median change from baseline to Week 78 in the DAD total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the DAD total score of 7 points or more and the worsening is confirmed by the DAD assessment at the next non-missing visit.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants||95% Confidence Interval|Number
1228521|NCT00676143|Secondary|Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score was <7.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participant|||Number
1228522|NCT00676143|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)|Percentage of participants with worsening from baseline to Week 78 in ADAS-Cog/11 total score of ≤0, ≤3, and ≤7 points were reported. In order to calculate time to first median placebo deterioration in ADAS-Cog/11, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining “deterioration” for Alzheimer’s disease participants in the study. If the median change from baseline to Week 78 in the ADAS-Cog/11 total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the ADAS-Cog/11 total score of 7 points or more and the worsening is confirmed by the ADAS-Cog/11 assessment at the next non-missing visit.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants||95% Confidence Interval|Number
1228523|NCT00676143|Secondary|Change From Baseline in Dependence Scale Total Score at Week 78|The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Unit on a scale||Standard Error|Least Squares Mean
1228524|NCT00676143|Secondary|Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening) from baseline in DAD total score of >=12.|Baseline and 78 Weeks||||Days||95% Confidence Interval|Median
1228525|NCT00676143|Secondary|Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)|The time to first median placebo deterioration was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
1228526|NCT00676143|Secondary|Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
1228527|NCT00676143|Secondary|Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)|The time to first median placebo deterioration, defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of median time to first median placebo deterioration was presented.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
1228544|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1228528|NCT00676143|Secondary|Divergence of Effect on the DAD Total Scores From Week 39 to Week 78|Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. DAD total score range is 0 to 100; a positive treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 –month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.|Week 39 to Week 78|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units/Year||Standard Error|Least Squares Mean
1228529|NCT00676143|Secondary|Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78|Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. ADAS-Cog/11 total score range is 0 (least impairment) to 70 (most impairment); a negative treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 –month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.|Week 39 to Week 78|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units/Year||Standard Error|Least Squares Mean
1228530|NCT00676143|Secondary|Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71|Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.|Baseline and 71 Weeks|vMRI population included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.|||Milliliter (mL)/year||Standard Error|Least Squares Mean
1228531|NCT00676143|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71|Biomarkers CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.|Baseline and 71 Weeks|CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).|||pg/mL||Standard Error|Least Squares Mean
1228532|NCT00676143|Secondary|Change From Baseline in Brain Amyloid Burden at Week 71|Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PIB) positron emission tomography (PET). The latter is a semi-quantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer’s pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.|Baseline and 71 weeks|PIB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one postbaseline PIB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI ≥1.35 at baseline.|||standard uptake value ratio||Standard Error|Least Squares Mean
1228533|NCT00676143|Primary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78|"The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant.~This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement."|Baseline and 78 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Unit on a scale||Standard Deviation|Least Squares Mean
1228545|NCT00676091|Secondary|Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.|||percentage of participants||95% Confidence Interval|Number
1234882|NCT00622284|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 104|Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104|Week 104|FAS (NCF)|||Percentage of patients|||Number
1228534|NCT00676143|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78|"The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.~This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced.~The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment."|Baseline and 78 weeks|The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.|||Unit on a scale||Standard Error|Least Squares Mean
1228535|NCT00676130|Secondary|Progression to Abscess|Proportion of subjects in each arm with progression from cellulitis to abscess.|12 +/- 2 days, 30 days +/- 2 days||||participants|||Number
1228536|NCT00676130|Primary|Relative Efficacy|"Proportion of subjects in each arm with successful treatment.~Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days."|12 +/- 2 days; 30 +/- 2 days|Of the 153 randomized subjects, 4 were randomized in error and did not receive study drug, 1 received two doses before it was discovered that he was ineligible, 1 was lost to follow up, and 1 withdrew voluntarily in the first few days after enrollment. This left 146 subjects for intent-to-treat analysis.|||participants|||Number
1228537|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1228538|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1228539|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1228540|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1228541|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1228542|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1228543|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1228569|NCT00675922|Secondary|Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients||Admission to burn unit to discharge|||||||
1228546|NCT00676091|Secondary|Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1228547|NCT00676091|Primary|Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.|||percentage of participants||95% Confidence Interval|Number
1228548|NCT00676091|Primary|Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 Month after the infant series (7 Months of age)|Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1228549|NCT00676065|Primary|Breast Cancer|Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
1228550|NCT00676065|Primary|Venous Thromboembolism|Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
1228551|NCT00676065|Primary|Arterial Thromboembolism|Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
1228552|NCT00676052|Secondary|Change From Baseline in Clinic Visit Trough FVC on Day 29|The trough FVC is defined as the mean of the FVC values obtained 23 and 24 hours after dosing on Day 28. The Baseline FVC is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.|Baseline (pre-dose Day 1) and Day 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.|||Liter||Standard Error|Least Squares Mean
1228553|NCT00676052|Secondary|Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29|Weighted means serial FVC was derived by calculating the AUC, and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.|Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.|||Liter||Standard Error|Least Squares Mean
1228554|NCT00676052|Secondary|Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29|Weighted means serial FEV1 was derived by calculating the area under curve (AUC), and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.|Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.|||Liter||Standard Error|Least Squares Mean
1228555|NCT00676052|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29|The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.|Baseline (pre-dose Day 1) and Day 29|ITT Population. Last observation carried forward (LOCF) data has been presented.|||Liter||Standard Error|Least Squares Mean
1228556|NCT00676026|Primary|To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.|Each medication will be administered 2 times during a 1-month menstrual cycle.|UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.||||||
1228557|NCT00675987|Secondary|Change in E-selectin|E-selectin is expressed on inflamed endothelial cells in response to treatment with inflammatory cytokines.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||ng/ml||95% Confidence Interval|Mean
1228558|NCT00675987|Secondary|Change in F2-isoprostanes|F2-isoprostanes is a marker of oxidative stress.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||ng/mg of creatinine||95% Confidence Interval|Mean
1228559|NCT00675987|Secondary|Change in Ox-LDL (Oxidized Low-density Lipoprotein)|ox-LDL measures protein damage due to the oxidative modification of the ApoB subunit on LDL cholesterol.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||units/l||95% Confidence Interval|Mean
1228560|NCT00675987|Secondary|Change in MCP-1 (Monocyte Chemoattractant Protein-1)|MCP-1 is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||pg/ml||95% Confidence Interval|Mean
1228561|NCT00675987|Secondary|Change in VCAM-1(Vascular Cell-adhesion Molecule-1)|VCAM-1 is an immunoglobulin-like adhesion molecule expressed on activated endothelial cells.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||ng/ml||95% Confidence Interval|Mean
1228562|NCT00675987|Secondary|Change in hsCRP (High-sensitivity C-reactive Protein)|hsCRP (high-sensitivity C-reactive protein) is a marker of inflammation|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||percentage change||95% Confidence Interval|Mean
1228563|NCT00675987|Secondary|Change in Urine Albumin/Creatine|Urine was obtained to assess for the presence of microalbuminuria.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||mg/mmol||95% Confidence Interval|Mean
1228564|NCT00675987|Primary|Insulin Sensitivity Utilizing Endothelial Function as Assessed by Pulse Volume Amplitude|Endothelial function assessed as the ratio of pulse volume amplitude after compared with before a reactive hyperemia stimulus, measured by peripheral (fingertip) arterial tonometry. Reported values indicate the percentage change from Baseline in the ratio of pulse volume amplitude after compared to before the reactive hyperemia stimulus.|baseline, 8 weeks|analysis was ITT, but limited to those with interpretable data (3 clamp studies were excluded)|||percentage change||Standard Deviation|Mean
1228565|NCT00675987|Primary|Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp|Insulin clamp derived insulin sensitivity, as insulin stimulated glucose disposal corrected for steady state insulin level.|baseline, 8 weeks|analysis was ITT, but limited to those with interpretable data (3 clamp studies were excluded)|||mg/kg/min||Standard Deviation|Mean
1228566|NCT00675948|Secondary|Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment|The EORTC Quality of Life-C30 Health Status visual analogue scale was a self-reported score where subjects rated their health state from: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score from baseline indicates an improvement in condition. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of mean EORTC Quality of Life-C30 Health Status scores was only produced when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.|0 - 657 days|The efficacy analyses were conducted on data from all randomised subjects who received at least one dose of study medication and who yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1228567|NCT00675948|Secondary|Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks subjects to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A negative value indicates an improvement in score from baseline. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of the mean Brief Pain Inventory (Short Form) score was only carried out when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.|0 - 657 days|The efficacy analyses were conducted on data from all subjects who entered the study, who were randomised, who received at least one dose of study medication and who yielded on-treatment efficacy data|||units on a scale||Standard Deviation|Mean
1228568|NCT00675948|Primary|The Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event in this study is presented.|0 - 657 days|All subjects who took at least one dose of study medication and yielded on-treatment efficacy data were classed as the safety population.|||participants|||Number
1228570|NCT00675922|Primary|Infection Rate|Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.|Acute hospitalization following burn injury: admission to discharge (1-20 weeks)|Percent of sites treated with sulfamylon of Silver Nitrate soaks that developed infections|||percentage of participants|||Number
1228571|NCT00675909|Secondary|Nurse Rating of Sedation|Range is 0-10. Higher is associated with nurse impression that sedation is better.|After the procedure nurse was asked about their impression of the level of sedation.||||units on a scale||Full Range|Median
1228572|NCT00675909|Secondary|Physician Rating of Sedation|Range is 0-10. Higher is associated with physician impression that sedation is better.|Physician was asked after the procedure was done about their impression of sedation.||||units on a scale||Full Range|Median
1228573|NCT00675909|Secondary|Duration of Procedure||Duration of procedure up to 40 minutes||||minutes||Full Range|Median
1228574|NCT00675909|Secondary|Time From Study Drug Administration to Start of Procedure||Time from study drug administration to start of procedure up to 68 minutes||||minutes||Full Range|Median
1228575|NCT00675909|Primary|Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair).|"Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation.~Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3)."|Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).|Intention to treat|||Scores on a scale||95% Confidence Interval|Median
1228576|NCT00675792|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.7, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.|||Minutes||Standard Deviation|Mean
1228577|NCT00675792|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.8, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.|||Minutes||Standard Deviation|Mean
1228578|NCT00675792|Secondary|Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.9, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.|||Minutes||Standard Deviation|Mean
1228579|NCT00675792|Secondary|Number of Participants With Evidence of Possible Interaction of Sugammadex With Endogenous Compounds or Exogenous Compounds Other Than Rocuronium Bromide|Evidence of adverse events due to a possible interaction of sugammadex with exogenous compounds or endogenous compounds other than rocuronium was recorded.|Up to 7 days after surgery|All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine|||participants|||Number
1228580|NCT00675792|Secondary|Number of Participants With Post-operative Complications|Post-operative complications include any of the following: procedural pain, nausea, vomiting, incision-site pain, constipation, headache, pyrexia, dizziness and pruritus.|Up to 7 days after surgery|All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine|||participants|||Number
1228581|NCT00675792|Primary|Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation|Neuromuscular function was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds, and assessing twitch response at the adductor pollicis muscle with a TOF-Watch® SX. The magnitudes (heights) of the first and fourth twitches (T1 and T4) were used to calculate the T4/T1 ratio, where a higher T4/T1 ratio indicates a greater recovery from neuromuscular blockade, with a value of 1.0 indicating complete recovery. After anesthesia, when neuromuscular function was expected to be fully recovered, tracheal extubation was performed, at which time the T4/T1 ratio was measured, with any missing recovery times imputed.|Up to the first 24 hours after tracheal extubation|Intent to treat (ITT) group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.|||T4/T1 Ratio||Standard Deviation|Mean
1228598|NCT00675506|Secondary|Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS|Change in post-exercise phosphocreatine recovery [ViPCr] between baseline and 12 months (positive change indicates increase in the variable between baseline and 12 months). ViPCR is the initial rate of phosphocreatine recovery normalized based on participant effort. Greater ViPCr represents relatively better mitochondrial function.|Measured at Baseline and Month 12|All available data. Assessment of mitochondrial function could not be performed in all patients.|||milliMoles/second||Standard Deviation|Mean
1228857|NCT00673153|Secondary|Number of Participants Achieving CR or CRi With Induction Therapy (Poor-risk Group)||after completion of induction therapy, administered every 21-42 days for up to two courses|Poor-risk Group: patients aged ≥70 years and performance status 2-3|||Participants|||Count of Participants
1228582|NCT00675766|Primary|Neuropsychological Status (i.e., Cognitive Functioning)|Neurocognitive functions refer to cognitive abilities, namely learning/memory, motor speed, psychomotor speed, language, attention, visuospatial abilities, & executive function. They are measured using standard clinical neuropsychological test battery that included: HVLT, BVMT-R, Trails A & B, WCST-64, WAIS-Symbol Search/Digit Coding/Letter-Number Sequencing/Block Design, FAS, & Animals. Subgroups of these tasks were combined to create composite scores indicating participants' score on each cognitive domains. To make these cognitive domain composite scores, each participant's raw score on each of these tests was converted into a within-sample standardized score (i.e., z-score), which are normally distributed with a mean of 0 & SD of 1. Then, these standardized scores were summed to create composite scores for each cognitive domain and then averaged to create a global neuropsychological function composite score. A positive composite score represents a better outcome for all variables.|Baseline (Year 1) and 1-year follow-up (Year 2)|HIV+ and HIV negative men who were evaluated BOTH at baseline and Year 2. Those participants who were evaluated at Baseline but not at Year 2 were excluded from analyses.|||z-score composites of cognitive domains||Standard Error|Mean
1228583|NCT00675597|Primary|To Measure the Number of Cycles|Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.|2 years||||participants|||Number
1228584|NCT00675584|Secondary|Change Between 12 Months and Baseline in the Caregiver Quality-of-life|The caregiver quality-of-life questionnaire consists of seven questions, each scored from 0 (worse) to 3 (best), and all seven questions are summed to yield a total score ranging from 0 to 21|baseline and 12 months|Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the analysis based on the linear mixed-effects model|||units on a scale||95% Confidence Interval|Least Squares Mean
1228585|NCT00675584|Secondary|Change in Wheeze Severity During a Respiratory Tract Illness|Wheeze severity is scored as 0 (none) to 5 (very severe) during a respiratory tract illness|Measured during the first seven days for each respiratory tract illness|The data from every respiratory tract illness is included in the analysis|||units on a scale||95% Confidence Interval|Mean
1228586|NCT00675584|Secondary|Proportion of Days With Rescue Albuterol Use||Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of days|||proportion of days||95% Confidence Interval|Mean
1228587|NCT00675584|Secondary|Number of Days of Absence From Daycare and Preschool for the Child and From Work for the Caregiver Per 12 Months||Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of days|||days per 12 months||95% Confidence Interval|Mean
1228588|NCT00675584|Secondary|Adverse Events Associated With Corticosteroid Use||Measured during the 12-month follow-up period|All randomized children are included|||Participants|||Count of Participants
1228589|NCT00675584|Secondary|Change Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometry||baseline and 12 months|Prior to enrollment of the first randomized study participant, the clinical investigators decided that it would be futile to perform oscillometry in children of the target age range for MIST (2-5 years of age). A previous CARE Network trial (PEAK) performed oscillometry in such children, but the data were highly variable and of poor quality.||||||
1228590|NCT00675584|Secondary|Change Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO)|Exhaled nitric oxide (eNO) is measured in parts per billion, and the change constructed between 12 months and baseline|baseline and 12 months|Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the analysis based on the linear mixed-effects model|||parts per billion||95% Confidence Interval|Least Squares Mean
1228591|NCT00675584|Secondary|Number of Participants With Treatment Failure|"Treatment failure was defined as the occurrence of at least one of the following events:~four courses of systemic corticosteroids~one hospitalization for acute exacerbation of wheezing~hypoxic seizure during an acute exacerbation of asthma/wheezing~intubation for acute asthma/wheezing~serious adverse event related to a study medication~physician discretion with specific rationale"|Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the assessment of treatment failure|||Participants|||Count of Participants
1228592|NCT00675584|Secondary|Number of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 Months||Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of urgent care visits|||visits per 12 months||95% Confidence Interval|Mean
1228593|NCT00675584|Secondary|Proportion of Episode-free Days|An episode-free day consisted of no asthma symptoms and no asthma rescue medications|Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the numerator and denominator of the proportion of episode-free days|||proportion of episode-free days||95% Confidence Interval|Mean
1228594|NCT00675584|Primary|Rate of Exacerbations Requiring Systemic Corticosteroids|The rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up|Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the numerator and denominator of the exacerbation rate|||events per years of follow-up||95% Confidence Interval|Mean
1228595|NCT00675558|Secondary|Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area|Fatty acid uptake was expressed relative to adipocyte cell surface area [Vmax’(pmol/sec/µm^2) = Vmax/(cell surface area) X 10^8].|4 years||||pmol/sec/μm^2||Standard Deviation|Mean
1228596|NCT00675558|Primary|Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake|The Vmax for facilitated Long Chain Fatty Acids (LCFA) uptake by omental adipocytes was measured.|4 years||||pmol/sec||Standard Deviation|Mean
1228597|NCT00675558|Primary|Size of Adipocytes|The mean diameters of omental adipocytes were measured|4 years||||µm||Standard Deviation|Mean
1228599|NCT00675506|Secondary|Change in Growth Hormone Pulse Characteristics (Median Pulse Mass) as Assessed by Overnight Frequent Sampling of Growth Hormone|Overnight frequent sampling of growth hormone levels was performed and characteristics of pulsatile secretion were determine using automated deconvolution (using AutoDecon software). Based on the deconvolution, the median pulse mass (in nanograms per millileter of growth hormone) was calculated. A positive number indicates an increase in median pulse mass between baseline and 12 months.|Measured at baseline and Month 12|All available data (all participants for whom change from baseline to 12 months was available)|||nanograms/milliliter||Standard Deviation|Mean
1228600|NCT00675506|Secondary|Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test|Glucose tolerance was determined after an overnight fast using standard 75 gram oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Change in glucose tolerance (fasting and 2 hour OGTT) between baseline and twelve months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.|||mg/dL||Standard Error|Mean
1228601|NCT00675506|Secondary|Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)|Lipid Profile (total cholesterol, high-density lipoproteins [HDL] cholesterol, low-density lipoproteins [LDL] cholesterol, triglycerides)was determined after an overnight fast. The change in lipid profile between baseline and 12 months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.|||mg/dL||Standard Error|Mean
1228602|NCT00675506|Secondary|Change in Carotid Intima-media Thickness|Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.|||mm||Standard Error|Mean
1228603|NCT00675506|Primary|Change in Visceral Adipose Tissue Volume|Abdominal visceral adipose tissue and subcutaneous adipose tissue were assessed using a single crosssectional slice from noncontrast computed tomography at the L4 level. The change in abdominal visceral adiposity between baseline and twelve months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.|||cm2||Standard Error|Mean
1228604|NCT00675441|Primary|Number of Participants' With Treatment Response of Complete or Partial Response|Treatment responses defined as complete (CR) or partial organ response (PR) of chronic Graft-Versus-Host Disease (GVHD) to lenalidomide. Complete organ response (CR) indicates resolution of all reversible manifestations related to chronic GVHD in a specific organ. Partial organ response (PR) requires at least 50% improvement in scale used to measure disease manifestations related to chronic GVHD. Tools for response evaluation were skin assessment and functional assessment including minute walk and grip strength.|Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days.|Of the five (5) participants enrolled, two participants were taken off study after only a few days of therapy and one participant expired, all three of which were not evaluable for response.|||participants|||Number
1228605|NCT00675428|Secondary|Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)||Cycle 1: Day 1 (1 hour before infusion and 1 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: 1 hour before and 1 hour after infusion). Cycle 6: Day 1 (1 hour before infusion and 1 hour after infusion), Days 8, 15, 22.|Analysis of binding saturation of α4 integrin sites was not performed because the study was terminated early.||||||
1228606|NCT00675428|Secondary|Pharmacokinetic (PK) Profile Of Natalizumab|PK modeling, either compartmental or noncompartmental-based, was used to describe serum concentrations. Standard PK parameters estimated include: area-under-the-concentration-time curve (AUC), maximum-observed concentration (Cmax), time-to-reach maximum concentration (Tmax), total body clearance (Cl), volume of distribution (Vd), and elimination half-life (t1/2).|Cycles 1 and 6: Day 1 (before infusion and 0.25, 2, 6 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: Day 1 (before infusion and 0.25 hour after infusion)|PK analysis was not performed because the study was terminated early.||||||
1228607|NCT00675428|Secondary|Kaplan-Meier Estimates for Duration Of Response For Participants With A Response|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Kaplan-Meier methods were used to estimate the median duration of response and associated 95% confidence intervals.|Day 1 up to Month 6|Duration of response was not calculated because the study was terminated early.||||||
1228608|NCT00675428|Secondary|Number Of Participants Who Achieve A Complete Response|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Complete Response (CR): negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas , and ≤ 5% plasma cells in the bone marrow. Stringent CR (sCR): CR as defined above, and normal free light chain (FLC) ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence, based on a κ/λ ratio of > 4:1 or < 1:2 performed on a minimum of 100 plasma cells.|Day 1 up to Month 6||||participants|||Number
1228609|NCT00675428|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered medicinal (investigational) product and that does not necessarily have a causal relationship with this product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See the adverse events section of the record for more details.|Day 1 up to Month 6||||participants|||Number
1228611|NCT00675428|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) >3*upper limit of normal (ULN) with either a total bilirubin >2*ULN or an international normalized ratio (INR) >1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.|Day 1 up to Day 28||||participants|||Number
1228612|NCT00675415|Secondary|Proportion of Participants Experiencing Apnea||Continuously measured during endoscopy, typically about 2 hours||||Participants|||Count of Participants
1228613|NCT00675415|Secondary|Proportion of Participants Experiencing Severe Hypoxemia||Continuously measured during endoscopy, typically about 2 hours||||Participants|||Count of Participants
1228614|NCT00675415|Secondary|Proportion of Participants Requiring Supplemental Oxygen||Continuously measured during endoscopy, typically about 2 hours||||Participants|||Count of Participants
1228615|NCT00675415|Primary|Number of Participants Experiencing Hypoxemia During Endoscopy|Hypoxemia was defined as oxygen saturation less than 90 percent for at least 15 seconds.|Continuously Assessed during a single endoscopic procedure, typically about 2 hours||||Participants|||Count of Participants
1228616|NCT00675259|Secondary|Overall Expression of LZTS1 Before and After Neoadjuvant Therapy as Assessed by Immunohistochemistry|LZTS1 expression in breast cancer cells collected prior to NCT|prior to surgery|LZTS1 expression in breast cancer cells collected prior to NCT was assessed in 27 patients who had evaluable core biopsies.|||patients|||Number
1228617|NCT00675259|Secondary|Evaluation of Dynamic Contrast-enhanced Magnetic Resonance Imaging in Assessing pCR at Baseline and After 2 Cycles of Neoadjuvant Therapy|Relative angiogenic volume (AV) was defined as the ratio of AV to the geometric volume of the tumor in the breast.|after 2 cycles of therapy|Data only available for 20 of the 28 evaluable patients|||ratio||Standard Deviation|Mean
1228618|NCT00675259|Primary|Side Effects of Weekly Nab-paclitaxel, Carboplatin and Bevacizumab|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0|Up to 4 weeks|all grade 3 adverse events|||patients|||Number
1228619|NCT00675259|Primary|Number of Patients With Pathologic Complete Response (pCR)|pCR was defined as the absence of viable invasive tumor cells in the surgical breast specimen and axillary lymph nodes.|every 4 weeks|Includes patients with triple negative breast cancer and ER+/PR+ breast cancer.|||patients|||Number
1228620|NCT00675103|Secondary|Mean Plasma Uric Acid|This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.|Baseline, Week 3 and Week 7|ITT population|||mg/dL||Standard Deviation|Mean
1228621|NCT00675103|Primary|Adverse Event Profile|Number of participants reporting events|6 months||||Number of participants|||Number
1228622|NCT00674986|Secondary|Glycemic Variability Pre and Post-Prandial Excursions at Each Meal|"Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion.~The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects."|Month 1, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||mg/dL||Standard Error|Least Squares Mean
1228623|NCT00674986|Secondary|Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day|SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period.|12 Months|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Tests/day||Standard Error|Least Squares Mean
1228624|NCT00674986|Secondary|Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)|Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.|Baseline, Month 12|Per protocol population included all enrolled participants who completed the baseline training visit, completed at least 4 of 5 clinical visits, and had evaluable HbA1c data at Month 12. The Structured Testing Group also had to have at least 80% of the blood glucose values.|||Score on a scale||Standard Error|Least Squares Mean
1228625|NCT00674986|Secondary|Change From Baseline in the World Health Organization (WHO-5) Well-being Index|Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Score on a scale||Standard Error|Least Squares Mean
1228626|NCT00674986|Secondary|Change From Baseline in the Diabetes Distress Scale (DDS)|Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Score on a scale||Standard Error|Least Squares Mean
1228627|NCT00674986|Secondary|Change From Baseline in Depression Severity (PHQ-8)|The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Score on a scale||Standard Error|Least Squares Mean
1228628|NCT00674986|Secondary|Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations|Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.)|12 Months|Intent to treat population included all enrolled participants who completed the Baseline training visit. Participants who dropped out before Month 1 visit were not included in the analysis.|||Visits||Standard Deviation|Mean
1228629|NCT00674986|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12|Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Percent||Standard Error|Least Squares Mean
1228630|NCT00674973|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|Up to 28 days after discontinuation of study drug (up to 30 months)|Safety population included all participants who received at least 1 dose of study medication and had a safety follow-up, whether withdrawn prematurely or not, were included in the safety population.|||participants|||Number
1228631|NCT00674973|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.|From the time of randomization until or death (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.|||months||95% Confidence Interval|Median
1228632|NCT00674973|Secondary|Percentage of Participants With Disease Control Rate (DCR)|Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
1228633|NCT00674973|Secondary|Percentage of Participants With Best Overall Response Rate|Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|From the time of randomization until progression of disease or death (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
1228634|NCT00674973|Primary|Progression-Free Survival|Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.|From the time of randomization until progression of disease or death (up to 30 months)|The Full-Analysis Set (FAS) was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.|||weeks||95% Confidence Interval|Median
1228635|NCT00674817|Secondary|Time to Last Quantifiable Plasma Concentration (Tlast) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Tlast is the time to last quantifiable plasma concentration of GSK961081 over period determined directly from the concentration-time data|Up to 82 days|PK population. All participants were present for the analysis; however, there were few participants for whom parameter could not be derived because of non-quantifiable concentration. Data is presented for the participants available at the time of assessment.|||hours||Full Range|Median
1228636|NCT00674817|Secondary|Time to Maximum Plasma Concentration (Tmax) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Tmax is the time to maximum plasma concentration of GSK961081 over period determined directly from the concentration-time data|Up to 82 days|PK population. All participants were present for the analysis; however, there were few participants for whom parameter could not be derived because of non-quantifiable concentrations. Data is presented for the participants available at the time of assessment.|||Hours||Full Range|Median
1228637|NCT00674817|Secondary|Maximum Plasma Concentration (Cmax) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Cmax is the Maximum observed concentration of GSK961081 determined directly from the concentration-time data. A large proportion of Cmax values were reported as not countable (NC ) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. Cmax was imputed with 1/2 lowest limit of quantification (LLQ), where LLQ was 25 picograms per milliliter (pg/mL).|Up to 82 days|PK population. All participants were present for analysis, however, there were few participants for whom parameter could not be derived because of non-quantifiable concentrations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1228638|NCT00674817|Secondary|Area Under Plasma Concentration Time Curve (AUC) of GSK961081 to the Last Quantifiable Concentration|AUC(0-t) is the area under plasma concentration time curve of GSK961081 to the last quantifiable concentration. This parameter was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. A large proportion of AUC(0-t) and Cmax values were reported as not countable (NC) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. AUC(0-t) imputed with 1/2 lowest observed AUC(0-t), where lowest AUC(0-t) was 56.46 hour picograms per milliliter (h*pg/mL).|Up to 82 days|Pharmacokinetic (PK) population included participants in the ‘All Subjects’ population for whom a PK sample was obtained and analyzed following GSK961081 dosing. All participants were available at the time of analysis; however, for few participants, parameter cannot be derived because of non-quantifiable concentrations.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1228639|NCT00674817|Secondary|Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position|Analysis of QT (B) or QTc (F) interval during ECG (taken in supine position) was performed using Bazett's method and Fridericia's method, respectively. Heart rate, BP, potassium, and glucose were measured in supine body position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population. n=data is presented for the participants available at the time of assessment.|||hours||Full Range|Median
1228640|NCT00674817|Secondary|Minimum Change From Baseline (Pre-dose on Day 1) in Potassium Over 4 and 27 Hours and Weighted Mean Change From Baseline in Potassium Over 4 Hours|Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in potassium (K) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Error|Least Squares Mean
1228641|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Glucose Over 4 and 27 Hours and Weighted Mean Change From Baseline in Glucose Over 4 Hours|Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in glucose (GLU) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Error|Least Squares Mean
1228642|NCT00674817|Secondary|Minimum Change From Baseline (Pre-dose on Day 1) in Supine Diastolic Blood Pressure (DBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine DBP Over 4 Hours|Diastolic blood pressure (DBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/(MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data .|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Error|Least Squares Mean
1228643|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Supine Systolic Blood Pressure (SBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine SBP Over 4 Hours|Systolic blood pressure (SBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/ (MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Error|Least Squares Mean
1228644|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate in Supine Position From 0 to 4 Hours|Heart rate was recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population. Data is presented for the participants available at the time of assessment.|||Beats per minute||Standard Error|Least Squares Mean
1228645|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Supine Heart Rate From 0 to 4 Hours and From 0 to 27 Hours.|Heart rate was measured in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h) and until 27 hours (0-27 h)|Modified Per Protocol population.|||Beats per minute||Standard Error|Least Squares Mean
1228646|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours|Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population.|||msec||Standard Error|Least Squares Mean
1228647|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours and 0 to 27 Hours|Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data .|From dosing until 4 hours (0-4h) and 27 hours (0-27h)|Modified Per Protocol population.|||msec||Standard Error|Least Squares Mean
1228648|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(F) in Supine Position From 0 to 4 Hours|Analysis of QT(F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified per protocol population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Least Squares Mean
1228649|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 27 Hours After Dosing|Analysis of Q T (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data .|From dosing until 27 hours (0-27h)|Modified per protocol population|||msec||Standard Deviation|Mean
1228650|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 4 Hours After Dosing|Analysis of QT (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as least square (LS) mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified per protocol population|||msec||Standard Deviation|Mean
1228651|NCT00674817|Secondary|Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings|Analysis QTc interval of ECG was performed by Bazett's formula (QTc B) and Fridericia's correction (QTc F). Number of participants with abnormal ECG findings were recorded. Any participant with QTc(B) or QTc(F) >500 milliseconds (msec) or uncorrected QT >600 msec (machine or manual over read) was withdrawn from the study. Participants that had right bundle branch block with QTc(B) or QTc(F) >530 msec were also withdrawn from the study.|From dosing until 24h post-dose.|All subjects population|||Participants|||Number
1228652|NCT00674817|Secondary|Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours|Heart rate was considered as a measure of vital sign. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value.|Up to 27 hours post Day 1 dosing|All subjects population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1228653|NCT00674817|Secondary|Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours|Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was analyzed. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value.|Up to 27 hours post Day 1 dosing|All subjects population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mm of Hg)||Standard Deviation|Mean
1228654|NCT00674817|Secondary|Number of Participants With Laboratory Abnormalities of Potential Clinical Concern (PCC)|The normal ranges of laboratory parameters were hemoglobin: 130-167 grams per deciliter (g/dL), platelets: 173–383 Giga per liter (GI/L), lymphocytes: 20.1–44.5 %, glucose: 3.8857–6.106 millimoles per liter (mmol/L), creatinine: 44.2–132.6 micromoles per liter (uM/L) , aspartate transaminases (AST): 12–32 international units per liter (IU/L), total bilirubin (TB): 4.275–25.65 uM/L and potassium: 3.4–4.7 mmol/L, respectively. Laboratory values recorded outside the normal range were considered of potential clinical concern (PCC).|Up to 42 days|All subjects population|||Participants|||Number
1228655|NCT00674817|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|Upto 82 days|All subjects population|||Participants|||Number
1228656|NCT00674817|Secondary|Maximal Change in Forced Vital Capacity (FVC) in One Second From Pre-dose in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h, 12h and 24h.|FVC is defined as the amount of air that can be forcibly exhaled from the lungs after a maximum inspiration as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.|Baseline (Pre-dose on Day 1), 1h, 12h, and 24h on Day 1|Modified per protocol population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1228657|NCT00674817|Primary|Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h.|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.|Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1|Modified per protocol population included the participants who received at least one dose of the study drug where major deviations from the protocol had not occurred. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1228658|NCT00674765|Primary|TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase|The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.|12 weeks||||percent days of heavy drinking|||Number
1228659|NCT00674739|Secondary|Treatment Related Adverse Events|Numbers of subjects in each treatment group reporting one or more adverse events|Up to 16 weeks|Patients with adverse events considered probably related or related to the administration of the product.|||Participants|||Number
1228660|NCT00674739|Primary|Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study|Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.|Up to 16 weeks|Intention to treat|||participants||95% Confidence Interval|Number
1228661|NCT00674739|Secondary|Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.|"Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.~Rest period was a temporary interruption of dosing dur to intolerable LSRs."|Up to 16 weeks||||participants|||Number
1228763|NCT00673764|Primary|Time at Best Corrected Visual Acuity|Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.|15 minutes, 45 minutes, and 90 minutes post-dose||||seconds||Standard Error|Median
1228662|NCT00674700|Secondary|Average Rhinitis Total Symptom Score (ARTSS)|The Rhinitis Total Symptom Score (RTSS) evaluates the presence and severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion (absence of symptom (0), mild symptom (1), moderate symptom (2), severe symptom (3)). It ranges from 0 to 12, the higher the score the more severe the rhinitis.|Last 3 months of Year 1|The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.|||Units on a scale (range: 0 to 12)||Standard Error|Least Squares Mean
1228663|NCT00674700|Primary|Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period|"The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).~It ranges from 0 to 12, the higher the score the more severe the rhinitis."|Last 3 months of Year 1|The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.|||Units on a scale (range: 0 to 12)||Standard Error|Least Squares Mean
1228664|NCT00674661|Primary|Mean Change From Baseline in Maximum Keratometry (Kmax)|The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.|baseline,12 months||||diopters||Standard Deviation|Mean
1228665|NCT00674622|Secondary|Pain Threshold on Dolorimetry|Pressure pain threshold (PPT) has been noted to correlate with pain and disability associated with LE. PPT was determined by applying pressure with a digital algometer over the area of maximal tenderness corresponding with the common extensor tendon area. Only 1 determination was obtained as the 1st application of pressure can lower the pain threshold for subsequent testing.|6 and 12 weeks post-intervention||||Pounds||Standard Deviation|Mean
1228666|NCT00674622|Secondary|Nirschl Pain Phase Scale|The Nirschl Pain Phase Scale (NPPS), which has been used to describe functional impairment related to tendinopathies such as lateral epicondylitis. This scale provides a global rating of impairment associated with sports and musculoskeletal injuries. A rating from 0-7 describes the phase of overuse injuries, with Phase 0 noting “No stiffness or soreness after activity” and Phase 7 corresponding with “Pain that also disrupts sleep consistently. Pain is aching in nature and intensifies with activity”. It was used as an indication of severity for entry into the study and as the criterion for treatment response.|6 and 12 weeks post-intervention||||units on a scale||Standard Deviation|Mean
1228667|NCT00674622|Secondary|Grip Strength|Maximal pain-free grip strength has been used as a physical correlate of disability associated with LE. Grip strength was obtained using a Jamar Dynamometer set in the 2nd position. 3 trials were recorded and the average pain-free grip strength was noted.|6 weeks and 12 weeks post-intervention||||pounds||Standard Deviation|Mean
1228668|NCT00674622|Secondary|QuickDASH|The QuickDASH is an abbreviated form of the rating scale DASH or Disabilities of the Arm, Shoulder, & Hand. This is a self-report rating of function for individuals with problems of the upper extremity. The Institute for Work and Health, in collaboration with the American Academy of Orthopaedic Surgeons developed a self-report questionnaire “Disabilities of the Arm, Shoulder, & Hand”. It is seen as a valid and reliable measure of upper extremity functional impairment, is in widespread use in the States and abroad, having been translated into multiple languages and has been used for studies on LE. 11 items are scored on this self-rating instrument on a 1-5 Likert scale with higher score reflecting greater disability. The scores are averaged and then converted to a 100 point scale (0-100), with higher score reflecting greater disability.|6 weeks and 12 weeks post-intervention||||units on a scale||Standard Deviation|Mean
1228669|NCT00674622|Primary|McGill Pain Questionnaire|This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.|6 weeks and 12 weeks post intervention||||units on a scale||Standard Deviation|Mean
1228670|NCT00674609|Primary|The Consumption of Escape Analgesic Medication.|Subjects recorded their use of escape medication each day on their diary card.|2 weeks: baseline - end of week 2 (last 3 days of treatment)|The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.|||tablets per day||Standard Deviation|Mean
1228671|NCT00674609|Secondary|Brief Pain Inventory Short Form|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|End of 2 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
1228672|NCT00674609|Secondary|EORTC Quality of Life Questionnaire (EORTC-QLQC30)|Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100|2 weeks; baseline and end of treatment (2 weeks)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
1228673|NCT00674609|Secondary|Concentration 0-10 Numerical Rating Scale|"The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper? where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
1228674|NCT00674609|Secondary|Appetite 0-10 Numerical Rating Scale|"The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your appetite has been throughout the day? where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
1228675|NCT00674609|Secondary|Memory 0-10 Numerical Rating Scale|"The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours? where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
1228676|NCT00674609|Secondary|Nausea 0-10 Numerical Rating Scale|"The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how sick you felt throughout the day? where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline."|2 weeks; baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
1228677|NCT00674609|Secondary|Sleep Disturbance 0-10 Numerical Rating Scale|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|2 weeks: baseline to end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
1228678|NCT00674609|Primary|The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.|"The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.|||units on a scale||Standard Deviation|Mean
1228679|NCT00674583|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to six months after vaccination (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1228680|NCT00674583|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1228681|NCT00674583|Secondary|Number of Subjects Reporting Specific Adverse Events|Specific AEs included: - rash (hives, idiopathic thrombocytopenic purpura, petechiae); - new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies); - conditions prompting emergency room (ER) visits.|Up to 6 months after vaccination (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1228682|NCT00674583|Secondary|Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
1228683|NCT00674583|Secondary|Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
1228858|NCT00673153|Secondary|Relapse-free Survival (Good- and Poor-risk Group)||At relapse|Poor-risk Group: patients aged ≥70 years and performance status 2-3; Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1|||Participants|||Count of Participants
1228684|NCT00674583|Secondary|Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 50 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
1228685|NCT00674583|Secondary|Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 30 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
1228686|NCT00674583|Secondary|Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations|Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1228687|NCT00674583|Secondary|Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1228688|NCT00674583|Primary|Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody|Vaccine response to MenC was defined as: -for initially seronegative subjects [i.e. rSBA-MenC titer below (<) 1:8], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|One month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1228689|NCT00674492|Primary|Attributes of Treatment Experience|Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior.|Zero to five years since ending treatment.||||participants|||Number
1228690|NCT00674466|Secondary|Reduction in Fasting Body Weight From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||kg||Standard Deviation|Mean
1228691|NCT00674466|Secondary|Reduction in Fasting Plasma Glucose From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||mg/dL||Standard Deviation|Mean
1228692|NCT00674466|Primary|Reduction of HbA1c From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||Percent (%)||Standard Deviation|Mean
1228693|NCT00674362|Other Pre-specified|Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission.|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
1228694|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
1228695|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission.|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
1228696|NCT00674362|Other Pre-specified|Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
1228697|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
1228859|NCT00673153|Primary|Number of Participants Alive at Day 30 (Poor-risk Group)||At day 30|Poor-risk Group: patients aged ≥70 years and performance status 2-3|||Participants|||Count of Participants
1228698|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
1228699|NCT00674362|Other Pre-specified|Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits|Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared.|From Week 24 up to Week 52|"All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.~An ad-hoc analysis has been performed on the Week 24 Responder Set (W24RS) which showed similar results."|||days||Standard Error|Mean
1228700|NCT00674362|Secondary|Change From Baseline in Fatigue Assessment Scale at Week 24|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 180 (90 CZP, 90 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method|||units on a scale||Standard Deviation|Mean
1228701|NCT00674362|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 183 (92 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method|||mm||Standard Deviation|Mean
1228702|NCT00674362|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 162 (81 CZP, 81 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method|||mm||Standard Deviation|Mean
1228703|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228704|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 166 (83 CZP, 83 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228705|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228706|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228707|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 166 (82 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228708|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228860|NCT00673153|Primary|Number of Participants Achieving CR or CRi With Induction Therapy (Good-risk Group)||after completion of induction therapy, administered every 21-42 days for up to two courses|Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1|||Participants|||Count of Participants
1228709|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228710|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228711|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228712|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement.|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
1228713|NCT00674362|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from Baseline is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 182 (91 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1228714|NCT00674362|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 24|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
1228715|NCT00674362|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 24|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
1228716|NCT00674362|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
1228717|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits|DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.|||Days||Standard Deviation|Mean
1228718|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI >3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.|||days||Standard Deviation|Mean
1228719|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI >2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.|||days||Standard Deviation|Mean
1228720|NCT00674362|Secondary|Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
1228721|NCT00674362|Secondary|28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24|DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
1228722|NCT00674362|Primary|Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1228723|NCT00674323|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.|||Letters||Standard Deviation|Mean
1228724|NCT00674323|Secondary|Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)|High resolution 6 meridian scans were performed to measure central retinal thickness.|Baseline and Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.|||micrometers||Standard Deviation|Mean
1228725|NCT00674323|Secondary|Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA|Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.|Baseline through end of study (6 months)|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.|||Participants|||Number
1228726|NCT00674323|Primary|Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)|Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.|Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.|||Participants|||Number
1228727|NCT00674297|Primary|Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients|Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL)|3 months||||ng/mL||Standard Deviation|Mean
1228728|NCT00674297|Primary|Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients|Biomarker sTF (pM)|3 months||||pM||Standard Deviation|Mean
1228729|NCT00674297|Primary|Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients|Biomarkers: IL6 (pg/mL), IL1β (pg/mL), IL8 (pg/mL), VEGF (pg/mL), TNFα (pg/mL), IFNα (pg/mL), IP10 (pg/mL), sCD40L (pg/mL)|3 months||||pg/mL||Standard Deviation|Mean
1228730|NCT00674206|Secondary|Overall Survival From Time of Study Entry|"The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived.~Note: Not all patients started the study at the same time so the time frame is different from the full range.~The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived."|132 weeks||||Weeks||Full Range|Median
1228731|NCT00674206|Primary|Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.|"A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions.~Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|8 weeks||||participants|||Number
1228732|NCT00674154|Secondary|Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm||one year|||||||
1228739|NCT00674115|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days|25 participants in each arm had good quality tracings and were included in the efficacy analysis.|||pH scale||Full Range|Median
1228740|NCT00673959|Primary|Drop Comfort Upon Instillation|Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.|upon instillation||||Units on a scale||Standard Deviation|Mean
1228741|NCT00673933|Secondary|Erythema Score (Mild and Moderate)1 Day After First Treatment|Patients with mild or moderate erythema 1 day after first treatment.|1 day after 1st treatment and baseline|ITT|||percentage of participants|||Number
1228742|NCT00673933|Secondary|Erythema Score (Mild and Moderate)Immediately After Second Treatment|Patients with mild or moderate erythema after second treatment.|Immediately after second treatment, 2 weeks after baseline|ITT|||percentage of participants|||Number
1228743|NCT00673933|Secondary|Change in Noninflammatory Lesion Counts From Baseline||4 weeks after last treatment, 6 weeks after baseline|ITT|||lesion count||Standard Deviation|Mean
1228744|NCT00673933|Secondary|Change in Inflammatory Lesion Counts From Baseline||4 weeks after last treatment, 6 weeks after baseline|ITT|||lesion count||Standard Deviation|Mean
1228745|NCT00673933|Secondary|Erythema Score (Mild and Moderate)Immediately After First PDT|Patients with mild or moderate erythema after first treatment at baseline.|Immediately after treatment at baseline|ITT|||percentage of participants|||Number
1228746|NCT00673933|Primary|Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment||4 weeks after last treatment, 6 weeks after baseline||||participants|||Number
1228747|NCT00673881|Primary|Total Cholesterol|Mean Change in total cholesterol from baseline to End-of-treatment (Day 95)|12 weeks||||mg/dL||Standard Deviation|Mean
1228748|NCT00673881|Secondary|Endogenous Bile Acid Excretion|Change in endogenous bile acid excretion from baseline to end-of-treatment|12 weeks|||||||
1228749|NCT00673881|Secondary|Neutral Sterol Endogenous Excretion|Change in neutral sterol endogenous excretion from baseline to end-of-treatment|12 weeks|||||||
1228750|NCT00673881|Secondary|Change in Bile Acid Excretion|Change in bile acid excretion from baseline to end-of-treatment|Baseline to 12 weeks|||||||
1228751|NCT00673881|Secondary|Change in Neutral Sterol Excretion|The excretion rate of fecal neutral and acidic sterols was measured as mg/day, for each individual three times during the 10 day period following the isotope infusions at baseline and end-of-treatment.|baseline to 12 weeks|||||||
1228752|NCT00673881|Secondary|Percent Change in de Novo Cholesterol Synthesis|Plasma DNC was measured three times from blood draws on the 3 visits in the 10 day period following the isotope infusion at baseline and again at end-of-treatment at 12 weeks, and expressed in percent. Change from baseline to end-of-treatment expressed as percent.|Baseline to 12 weeks|||||||
1228753|NCT00673881|Secondary|Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)|Change in FCR from baseline to end-of-treatment (12 weeks)|Baseline to 12 weeks|||||||
1228754|NCT00673881|Secondary|Plasma Cholesterol Efflux|Change in efflux rate from baseline to end-of-treatment. The efflux rate of cholesterol from peripheral tissues into the plasma was measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® or Liposyn® and 10 % ethanol was given piggy-backed into normal saline over 24 hours. This was used to determine rate of appearance (Ra) cholesterol, measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol traced into biliary sterols.|12 weeks|||||||
1228755|NCT00673881|Primary|Mean Change in High Density Lipoprotein Cholesterol|Mean change in plasma high density plasma lipoprotein cholesterol (HDL-C)baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)|Baseline to 12 weeks||||mg/dL||Standard Deviation|Mean
1228756|NCT00673881|Primary|Mean Change in Plasma Triglycerides|Change in plasma triglyceride, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)|baseline to 12 weeks|per protocol|||mg/dL||Standard Deviation|Mean
1228757|NCT00673881|Primary|Mean Change in Calculated Low Density Lipoprotein Cholesterol|Mean change in calculated LDL, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,average Day 95)|baseline to 12 weeks||||mg/dL||Standard Deviation|Mean
1228758|NCT00673855|Primary|Drop Comfort Upon Instillation|Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.|Three minutes||||Units on a scale||Standard Deviation|Mean
1228759|NCT00673816|Secondary|Change in Retinal Angioma Leakage From Baseline to Week 36|"Leakage of the retinal angioma was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume."|Baseline and 36 Weeks|||||||
1228760|NCT00673816|Secondary|Change in Retinal Thickness From Baseline to Week 36|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 36 Weeks||||µm|||Number
1228761|NCT00673816|Primary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 36 Weeks||||ETDRS Letters|||Number
1228762|NCT00673764|Secondary|Functional Blink Rate Time (Time Between Blinks)|Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.|15 minutes, 45 minutes, and 90 minutes post-dose||||seconds||Standard Deviation|Mean
1228764|NCT00673738|Secondary|Overall Response Rate (ORR)|ORR = Complete Response (CR) + Partial Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response: Disappearance of all target lesions; Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 36 months|All participants|||percentage of participants||95% Confidence Interval|Number
1228765|NCT00673738|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time from randomization until death from any cause.|Up to 36 months|All participants|||months||95% Confidence Interval|Median
1228766|NCT00673738|Primary|Median Progression Free Survival (PFS)|Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 36 months|All participants|||months||95% Confidence Interval|Median
1228767|NCT00673712|Secondary|Hospital Length of Stay|time (days) from date of admission to discharge|primary admission|all randomized subjects|||days||Standard Deviation|Mean
1228768|NCT00673712|Secondary|Surgical Site Infection|surgical site infection diagnosed within 30 days post surgery|30 days postoperative|all randomized subjects|||participants|||Number
1228769|NCT00673712|Primary|Hospital Acquired Pneumonia|Pneumonia diagnosed during hospitalization|30 days postoperative|all randomized subjects|||participants|||Number
1228770|NCT00673673|Secondary|Overall Survival||Upon completion of study, up to 3 years||||months||95% Confidence Interval|Median
1228771|NCT00673673|Secondary|Overall Tumor Response Rate by RECIST Criteria|"Per response evaulation criteria in solid tumors criteria (RECIST) for target lesions assessed by FDG-PET Scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Upon completion of study||||percentage of participants|||Number
1228772|NCT00673673|Primary|Progression Free Survival||Upon completion of study, up to 3 years||||months||95% Confidence Interval|Median
1228773|NCT00673660|Secondary|Number of Participants With Reasons of Non-compliance to Statin Treatment|Participants were called for a final visit and reasons for non-compliance were recorded.|Month 12|Primary analysis population, subset of evaluable participants|||participants|||Number
1228774|NCT00673660|Secondary|Number of Participants With Reasons of Compliance to Statin Treatment|Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.|Month 12|Primary analysis population. The number of participants with reasons of compliance to statin treatment were not collected or analyzed.|||participants|||Number
1228775|NCT00673660|Secondary|Available Lipid Profiles of Compliant and Non-compliant Participants|Available laboratory measurements of participants were recorded in CRFs.|Month 12|Primary analysis population, subset of evaluable participants.|||milligrams per deciliter||Standard Deviation|Mean
1228776|NCT00673660|Primary|Percentage of Participants Who Were Compliant With Statin Treatment|The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.|Month 12|Primary analysis population: participants diagnosed with dyslipidemia who were taking or planning to take statin treatment. Subset of evaluable participants were analyzed.|||Percentage of participants|||Number
1228777|NCT00673595|Secondary|24-hour Ambulatory Blood Pressure|Ambulatory blood pressure will be measured using the Spacelabs 90202 recorder. Systolic and diastolic blood pressure during the 24-hour period will be analyzed.|2 weeks after participants quit smoking (study visit 3, day 15)|This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.|||mm Hg||Standard Deviation|Mean
1228778|NCT00673595|Primary|Arterial Endothelial Function as Measured by Flow-mediated Dilation|Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area. This blood flow will be induced by inflation of a blood pressure cuff placed around the forearm to a pressure of at least 50 mm Hg above systolic pressure for 5 min, followed by release. The ultrasound image of the artery will be recorded continuously from 30 sec before until 2 min after cuff release.|2 weeks after participants quit smoking (study visit 3, day 15)|This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.|||mm||Standard Deviation|Mean
1228779|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Tmax (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.||||||
1228780|NCT00673465|Secondary|Pharmacokinetic: Mean Time to Maximum Observed Plasma Concentration (Tmax) (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo).||||||
1228861|NCT00673127|Secondary|Time to Progression|Duration of time from treatment initiation until documented progression (PSA or Disease progression)|Duration of time from treatment initiation until documented progression. Maximum 32 months||||months||95% Confidence Interval|Median
1228781|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Cmax (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.||||||
1228782|NCT00673465|Secondary|Pharmacokinetic: Mean Maximum Observed Plasma Concentration (Cmax) (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo).||||||
1228783|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.||||||
1228784|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of type 2 diabetes mellitus [T2DM] participants after four weeks of treatment with SCH 497079 vs. placebo).||||||
1228785|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 2 - India)|The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Baseline and Week 4|No participants were randomized to treatment during Part 2 of the study.||||||
1228786|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States)|The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Baseline and Week 4|All participants who completed study treatment with at least SCH 497079 and placebo.|||mg/dL||Standard Error|Least Squares Mean
1228787|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)|The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|No participants were randomized to treatment during Part 2 of the study.||||||
1228788|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)|The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|All participants who completed study treatment with at least SCH 497079 and placebo.|||mg/dL||Standard Error|Least Squares Mean
1228789|NCT00673465|Secondary|Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 14 days after last dose of study drug (up to 98 days)|No participants were randomized to treatment during Part 2 of the study.||||||
1228790|NCT00673465|Secondary|Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 14 days after last dose of study drug (up to 98 days)|All randomized participants.|||Participants|||Number
1228791|NCT00673465|Primary|Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)|Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 mnutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|No participants were randomized to treatment during Part 2 of the study.||||||
1228792|NCT00673465|Primary|Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)|Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|All participants who completed study treatment with at least SCH 497079 and placebo.|||mg/dL||Standard Error|Least Squares Mean
1228793|NCT00673452|Secondary|Change From Baseline in Weight at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.|||kilograms (kg)||Standard Error|Least Squares Mean
1228794|NCT00673452|Secondary|Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)|"C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline through 12 Weeks|Number of randomized patients.|||participants|||Number
1228795|NCT00673452|Secondary|Change From Baseline in Heart Rate at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1228796|NCT00673452|Secondary|Change From Baseline in Blood Pressure at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.|||mm Hg||Standard Error|Least Squares Mean
1228797|NCT00673452|Secondary|Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint|Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).|12 weeks|Number of randomized patients with baseline and at least one post-baseline data.|||participants|||Number
1228798|NCT00673452|Secondary|Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint|Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).|12 Weeks|Number of randomized patients with baseline and at least one post-baseline data.|||participants|||Number
1228799|NCT00673452|Secondary|Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint|Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
1228800|NCT00673452|Secondary|Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint|"The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = greater than normal to 6 = totally absent. Total score ranges from 7 to 42."|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
1228801|NCT00673452|Secondary|Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks|The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
1228802|NCT00673452|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint|BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
1228803|NCT00673452|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint|The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 12 Weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
1228804|NCT00673452|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint|BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
1228805|NCT00673452|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint|MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
1228806|NCT00673452|Secondary|Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint|BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1228807|NCT00673452|Primary|Patient's Global Impressions of Improvement (PGI-I) at Week 12|The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “very much improved,” a score of 4 indicates that the patient has experienced “no change,” and a score of 7 indicates that the patient is “very much worse.”|12 weeks|Number of randomized patients with baseline PGI-S and at least one post-baseline PGI-I data.|||units on a scale||Standard Error|Least Squares Mean
1228808|NCT00673439|Secondary|the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux||4 weeks after INR reaches 2 or more|||||||
1228809|NCT00673439|Primary|the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux|Study terminated, results data not available|at fondaparinux discontinuation|||||||
1228810|NCT00673400|Other Pre-specified|SF36 Component Summary Scores|"Quality of life short form 36 version 2(SF36v2) standard form~PCS: physical component summary score (range 1 to 81, with 81 being the best) MCS: mental component summary score (range -9 to 82, with 82 being the best)~A score of 50 correlates with the result of a healthy standard US population (score transformation to a mean of 50 and a standard deviation of 10)~Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000."|Before surgery - 6 months||||units on a scale||Inter-Quartile Range|Median
1228811|NCT00673400|Other Pre-specified|Obstructive Defecation Syndrome Score|"Score based on severity or frequency of 9 symptoms of obstructive defecation (physician administered)~(0 - 40, no symptoms = 0)~Dis Colon Rectum 51:348(DOI: 10.1007/s10350-007-9115-1)"|before surgery - 6 weeks -3 months - 6 months||||units on a scale||Inter-Quartile Range|Median
1228812|NCT00673400|Other Pre-specified|Severity of Symptoms Score|"Score based on the severity of 9 symptoms of bowel movement (physician administered)~(0 - 36, no symptoms = 0)~Dis Colon Rectum 39:681 (DOI: 10.1007/BF02056950)"|before surgery - 6 weeks - 3 months - 6 months||||units on a scale||Inter-Quartile Range|Median
1228813|NCT00673400|Secondary|Hospitalization|Length of hospital stay (Date of release - Date of admission + 1)|1 day to 1 year (until release from hospital)||||days||Full Range|Median
1228814|NCT00673400|Secondary|Morbidity|Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)|1 year||||participants|||Number
1228815|NCT00673400|Primary|Quality of Life|"Quality of life is measured by Fecal incontinence quality of life (FIQL)~Possible range of score 0 - 4 (Depression/Self perception 4.4)~0 = worst condition~Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)"|6 months after intervention|Participating in the FIQL survey was voluntarily. Some patients did not participate at all, some did not answer all questions. Patients answering >=50% of questions of a domain were counted as participants|||units on a scale||Inter-Quartile Range|Median
1228816|NCT00673387|Secondary|Mean Change From Screening to Week 28 in the Electrocardiogram Parameter of Heart Rate - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained at Screening (visit 2), Day 1, Weeks 1, 12, 28 (study termination). Heart Rate was measured in beats per min (bpm).|Screening to Week 28 (or early termination)|Intent to treat population included all randomized participants who received at least one injection of study medication.|||bpm||Standard Deviation|Mean
1228817|NCT00673387|Secondary|Mean Change From Screening to Week 28 in Electrocardiogram Parameters - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained at Screening, Day 1, Weeks 1, 12, 28 (study termination). The PR interval, which is time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval (time from the beginning to the end of the QRS complex); QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).|Screening to Week 28 (or study termination)|Intent to treat population included all randomized participants who received at least one injection of study medication.|||msec||Standard Deviation|Mean
1228818|NCT00673387|Secondary|Number of Participants With Treatment-emergent Positive Anti-leptin Antibody Titers at Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||participants|||Number
1228819|NCT00673387|Secondary|Mean Change in Heart Rate From Baseline to Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28.|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||bpm||Standard Deviation|Mean
1228820|NCT00673387|Secondary|Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||mm Hg||Standard Deviation|Mean
1228821|NCT00673387|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population|Obtained at: Screening, Days -7, 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of laboratory values are cumulative across the study. Criteria for values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma/serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.|Screening to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||Number of Laboratory Values|||Number
1228822|NCT00673387|Secondary|Number of Hematology and Urinalysis Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of values are cumulative across the study.|Screening to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||Number of Laboratory Values|||Number
1228823|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population|The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Error|Mean
1228824|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Minutes to Fall Asleep, Hours of Sleep and The Pittsburgh Sleep Quality Index (PSQI) Global Score - Evaluable Population|The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire which assesses sleep quality and sleep disturbances over a period of 1 month. The PSQI provides ratings on seven domains of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). The sum of the individual domains yields a global sleep quality score with a range of 0-21. A PSQI score >5 is indicative of poor sleep, which is characterized by severe difficulties in at least two domains, or moderate difficulties in three or more domains. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Deviation|Mean
1228832|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray Absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Fat-free mass were measured in kilogram (k).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.|||kg||Standard Error|Least Squares Mean
1228825|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population|The POMS is a mood scale consisting of 65 mood adjectives that assess participants’ mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each of the six POMS factors. The mood adjectives load onto 6 mood factors, which are as follows: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. The factor scores are added to obtain the total mood disturbance score. A lower total mood disturbance score indicates improvement. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Error|Mean
1228826|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The higher the score, the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Error|Mean
1228827|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population|The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale (ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores indicate improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Deviation|Mean
1228828|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population|The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants’ perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. The minimum and maximum score for the BES instrument is 0 and 55, respectively. The higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Deviation|Mean
1228829|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite) Total Score - Evaluable Population|Subjective effects of weight loss were measured using the IWQOL-Lite questionnaire, a 31-item patient reported outcome (PRO) instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items have a range of 1 to 5 with 5=always true and 1= never true. The total score for the IWQOL-Lite instrument is measured on a scale from 0 (worst) to 100 (best). Higher scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Deviation|Mean
1228830|NCT00673387|Secondary|Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population|Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. Parameter was measured micro international units per milliliter. (µIU/mL).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding.|||µIU/mL||Standard Error|Least Squares Mean
1228831|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Fasting Plasma Glucose, Total Cholesterol (TC), Triglycerides, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol - Evaluable Population|Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. All parameters were measured in milligrams per deciliter (mg/dL).|Baseline to Week 28|Evaluable population: received at least one dose of randomized treatment, had adequate exposure to treatment, complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) presented above for TC, LDL and HDL cholesterol. Glucose n= 43, 50, 41, 46, 45, 43,44,36; Triglycerides n= 44,50,41,46,45,44,44.38.|||mg/dL||Standard Error|Least Squares Mean
1228841|NCT00673387|Secondary|Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population|Baseline refers to Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used.|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.|||participants|||Number
1228833|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Body fat mass was measured in kilogram (k).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.|||kg||Standard Error|Least Squares Mean
1228834|NCT00673387|Secondary|Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan and reported as a percent (%). Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Absolute change from baseline was defined as percent body fat at Week 28 - percent body fat at baseline.|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.|||percentage of body fat||Standard Error|Least Squares Mean
1228835|NCT00673387|Secondary|Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide|Assessment of Cmax was over a period of 2 hours following pramlintide administration at Weeks 4 and 24. Cmax was measured as picograms/milliliter (pg/mL).|Week 4 and Week 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4 n=46,40,41,40,40,33 in each arm, respectively; Week 24 n=48,38, 44,40,35,36 in each arm, respectively.|||pg/mL||Standard Error|Geometric Mean
1228836|NCT00673387|Secondary|Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide|Assessment of AUC was over a period of 2 hours following pramlintide administration. Area under the concentration curve (AUC) time 0 to infinity (-inf). For AUC calculations, concentration at -5 min will be considered as 0 h concentration if quantifiable. AUC measured in picograms*hour/milliliter (pg*h/mL).|Weeks 4 and 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4: n=39,36,37,36,35,31 in each arm, respectively; Week 24 n=46, 35, 42, 39, 33, 35 in each arm, respectively.|||pg*h/mL||Standard Error|Geometric Mean
1228837|NCT00673387|Secondary|Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide|Assessment of AUC was over a period of 2 hours following pramlintide administration. AUC (0 to time of last quantifiable concentration (-tlast). For AUC calculation, concentration at -5 min will be considered as 0 h concentration if quantifiable, otherwise, t=0 h. AUC measured as picograms*hour/milliliter (pg*h/mL). Pramlintide concentrations measured using a colorimetric immunoenzymetric assay employing monoclonal antibodies against pramlintide for both capture and detection.|Week 4 and Week 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4:n=46, 40,41, 40,40,33 in each arm respectively;Week 24:n=48, 38, 44, 40, 35, 36.|||pg*h/mL||Standard Error|Geometric Mean
1228838|NCT00673387|Secondary|LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population|Waist circumference was measured at baseline (Day 1), Weeks 12, 28 (or at early termination) in centimeters (cm).|Baseline to Weeks 12 and Week 28|Participants who received at least 1 dose of randomized treatment and who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock/unblinding. Numbers (n) analyzed Week 12 n=45,51,41,47,45,45,45,38 in each treatment group respectively; Week 28 n= 44, 51, 41, 46, 45, 44, 43, 38 in each group, respectively.|||cm||Standard Error|Least Squares Mean
1228839|NCT00673387|Secondary|LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population|Least Squares (LS) mean absolute change in Body weight was measured in kilograms (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used.|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.|||kg||95% Confidence Interval|Least Squares Mean
1228840|NCT00673387|Secondary|Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population|Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Evaluable population: all participants who received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Leptin concentrations measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc.|Baseline to Week 28|Number analyzed (n) at baseline above. Week 4: n=41 45,46, 45, 45, 38; Week 8: n=41,45,46,44,45,37; Week 12: n=41, 46, 46, 45,45,38; Week 16: n=41,47,46,45,45,38; Week 20: n=41, 45,45,45,45,38; Week 24: n=40, 43, 46, 42, 44,38; Week 28: n=41, 45, 45, 44, 43, 36. Leptin concentration for placebo and pramlintide plus placebo groups not presented.|||ng/mL||Standard Deviation|Mean
1228856|NCT00673153|Secondary|Number of Participants Alive at Day 30 (Good-risk Group)||At day 30|Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1|||Participants|||Count of Participants
1228842|NCT00673387|Primary|Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population|Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups).|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.|||Percentage change in kg||95% Confidence Interval|Least Squares Mean
1228843|NCT00673361|Secondary|Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria||post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years|||||||
1228844|NCT00673361|Primary|Progression Free Survival (PFS)|Terminated study before accrual goal, no data analysis|3 weeks, 6 weeks, 16 weeks, & 24 weeks|||||||
1228845|NCT00673257|Primary|Population Estimates for Daunorubicinol Volume of Distribution|Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.|prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.|There were 107 patients enrolled, 4 participants withdrew consent and there was 1 participant with insufficient specimen. 4 other participants were not analyzed as all samples time points were required for analysis and were not available.|||Liter||Standard Deviation|Mean
1228846|NCT00673257|Primary|Population Estimates for Daunorubicinol Clearance|Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.|prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.|There were 107 patients enrolled, 4 participants withdrew consent and there was 1 patient with insufficient specimen. 4 other participants were not analyzed as all sample time points were required for analysis and were not available.|||L/m2/hr||Standard Deviation|Mean
1228847|NCT00673257|Secondary|Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count|Multivariate analysis of the data will also be performed. Assess the significance of the relationship between the following characteristics: BMI, BSA, ALT, bilirubin, age, gender, and ethnicity, and daunomycin PK parameters.|Length of study|||||||
1228848|NCT00673231|Other Pre-specified|Proportion of Participants With Lack of Glycemic Control|Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets|Baseline to Week 24|Full Analysis Set|||Participants|||Number
1228849|NCT00673231|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
1228850|NCT00673231|Secondary|Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction|To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1228851|NCT00673231|Secondary|Adjusted Mean Change in Calculated Mean Daily Insulin Dose|To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||IU/day||95% Confidence Interval|Least Squares Mean
1228852|NCT00673231|Secondary|Adjusted Mean Change in Body Weight|To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
1228853|NCT00673231|Primary|Adjusted Mean Change in HbA1c Levels|To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
1228854|NCT00673179|Secondary|Quality of Life (Ped QL) Assessment||Peds QL measures at week 0 (during first chemo cycle), week 6, week 20, at end of therapy, and at 3 years.|||||||
1228855|NCT00673179|Primary|Treatment Success (6 or Fewer Hospitalizations During Front-line Chemotherapy)|Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.|Baseline to 5 Years|Study terminated early without analysis.||||||
1228862|NCT00673127|Primary|PSA Response|PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.|From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.||||percentage of participants||95% Confidence Interval|Number
1228863|NCT00673114|Secondary|Number of Participants With Donor Cells at 100 Days Post-transplant||Post transplant||||participants|||Number
1228864|NCT00673114|Secondary|Rates of Leukemic Relapse|Number of participants relapsed|Up to 2 years post transplant||||participants|||Number
1228865|NCT00673114|Secondary|Number of Participants With Acute or Chronic Graft-versus-host Disease (GVHD)|Acute and chronic GVHD|two years||||participants|||Number
1228866|NCT00673114|Secondary|Incidence of Primary and Secondary Graft Failure|Number of participants experiencing graft failure.|100 days post transplant||||participants|||Number
1228867|NCT00673114|Secondary|Platelet Engraftment (Untransfused and Platelet Count > 50,000)|Participants platelet engrafted.|Approximately 1 year||||participants|||Number
1228868|NCT00673114|Secondary|Non-Relapse Mortality at 180 Days Post Transplant||180 days||||participants|||Number
1228869|NCT00673114|Secondary|180 Day Survival|Number of participants alive at 180 days post transplant|180 days||||participants|||Number
1228870|NCT00673114|Primary|The Number of Participants Reaching Primary Endpoint of Absolute Neutrophil Count (ANC) of 500/uL (Engraftment).||By day 100||||participants|||Number
1228871|NCT00673075|Secondary|Left Ventricular Ejection Fraction (LVEF) (%) at Week 18|Left ventricular ejection fraction (LVEF) (%) at Week 18|18 weeks post-treatment||||percentage||Standard Error|Mean
1228872|NCT00673075|Secondary|Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18|Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18|18 weeks post-treatment||||participants|||Number
1228873|NCT00673075|Secondary|Peripheral Systolic Blood Pressure (SBP)|Peripheral systolic blood pressure (SBP) at visit 13 (week 18)|18 weeks post initiation of randomized treatment||||mmHg||Standard Error|Mean
1228874|NCT00673075|Primary|Peripheral Diastolic Blood Pressure (DBP)|Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)|18 weeks post initiation of randomized treatment||||mmHg||Standard Error|Mean
1228875|NCT00673049|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5, and EOT (21-28 Days After Last Dose)|QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprise 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)|This outcome measure was added in Protocol Amendment 3 (28 January 2010). However, data were not collected as the majority of the subjects had already been enrolled prior to this amendment and the study was terminated shortly thereafter (02 March 2010).||||||
1228876|NCT00673049|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)|EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)|This outcome measure was added in Protocol Amendment 3 (28 January 2010). However, data were not collected as the majority of the subjects had already been enrolled prior to this amendment and the study was terminated shortly thereafter (02 March 2010).||||||
1228877|NCT00673049|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)|EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every other cycle and EOT (21-28 days after last dose)|Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.||||||
1228878|NCT00673049|Secondary|Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)||Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)|Due to futility, the study was terminated early; therefore biomarker results were not analyzed.||||||
1228879|NCT00673049|Secondary|Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)|ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.|Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group|"Analysis population included all participants treated with figi. Data are combined for figi+erlo and erlo then figi because the objective was to report any participants with positive ADA after exposure to figi regardless of figi administration order, rather comparison of these 2 treatment groups. N=number of participants evaluable."|||percentage of participants|||Number
1228880|NCT00673049|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab||Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group|Due to futility, the study was terminated early; therefore pharmacokinetic data were not analyzed.||||||
1228881|NCT00673049|Secondary|Maximum Observed Plasma Concentration (Cmax) for Figitumumab||Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group|Due to futility, the study was terminated early; therefore pharmacokinetic data were not analyzed.||||||
1228882|NCT00673049|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response (OR) based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR are defined as complete disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.|||percentage of participants||95% Confidence Interval|Number
1228883|NCT00673049|Secondary|Progression Free Survival (PFS)|Time from randomization to date of first documentation of progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, who had a baseline and at least 1 on-study disease assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions.|Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.|||months||95% Confidence Interval|Median
1228884|NCT00673049|Primary|Overall Survival|The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.|Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.|||months||95% Confidence Interval|Median
1228885|NCT00672984|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||ng.h/ml||Standard Deviation|Mean
1228886|NCT00672984|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||ng.h/ml||Standard Deviation|Mean
1228887|NCT00672984|Secondary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||hours||Standard Deviation|Mean
1228888|NCT00672984|Secondary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||hours||Standard Deviation|Mean
1228889|NCT00672984|Secondary|Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||ng/ml||Standard Deviation|Mean
1228890|NCT00672984|Secondary|Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|Pharmacokinetic (PK) population consists of all subjects in the safety population (subjects who had taken one dose of study medication and had one follow-up safety assessment completed) who had evaluable concentration-time profiles.|||ng/ml||Standard Deviation|Mean
1228891|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
1228892|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
1228893|NCT00672984|Primary|Change From Baseline in Heart Rate (HR) at Tmax on Day 6||Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||bpm||Standard Error|Least Squares Mean
1228894|NCT00672984|Primary|Change From Baseline in Heart Rate (HR) at Tmax on Day 1||Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||bpm||Standard Error|Least Squares Mean
1228895|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
1228896|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
1228897|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6|QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
1228898|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1|QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline, Tmax (time of subject-specific maximum plasma concentration)|"Pharmacodynamic (PD) population consists of all evaluable subjects with no major protocol deviations. Evaluable subjects were defined as subjects who received a Day 6 dose and had Day 6 data for the primary and secondary endpoints for all three periods."|||msec||Standard Error|Least Squares Mean
1228899|NCT00672958|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 6|Full analysis set.|||participants|||Number
1228900|NCT00672958|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 6|Full analysis set where data were available; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1228901|NCT00672958|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36) at Week 6|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 6|Full analysis set where Baseline SF-36 data were available; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1228902|NCT00672958|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)|The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228903|NCT00672958|Secondary|Clinical Global Impression Scale-Global Improvement Scale|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228904|NCT00672958|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228905|NCT00672958|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A)|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least squares means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228906|NCT00672958|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least square means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228907|NCT00672958|Secondary|Percentage of Participants With a Sustained Response in HAM-D24|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 5 and at least 50% decrease from Baseline at Week 6.|Baseline to Week 6|Full analysis set. Participants with missing values were classified as nonsustained responders/remitters.|||percentage of participants|||Number
1228908|NCT00672958|Secondary|Percentage of Participants in MADRS Remission at Week 6|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 6|Full analysis set; LOCF was used.|||percentage of participants|||Number
1228909|NCT00672958|Secondary|Percentage of Responders in HAM-D24 Total Score by Study Visit|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1228910|NCT00672958|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4 and 5|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228911|NCT00672958|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 6|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
1228912|NCT00672932|Primary|Change in CSF Concentrations of Neopterin After 12 Weeks|CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.|three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)|One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.|||nmol/L||Standard Deviation|Mean
1228913|NCT00672932|Secondary|Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR|Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR.|three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)|One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.|||percentage of cells||Standard Deviation|Mean
1228914|NCT00672854|Secondary|Mean Change in Percentage of Granulocyte Phagocytosis After 7-day Administration of Parenteral Nutrition Between the Two Treatment Groups|Change in immune function is assessed by percentage of Granulocyte phagocytosis after 7-day administration of parenteral nutrition between the two treatment groups. The phagocytic and oxidative burst activity of monocytes and granulocytes in heparinized whole blood was assessed according to manufacturer’s instructions using specific reagent kits for this purpose at baseline and again at day 7. Briefly, granulocyte phagocytic activity was quantitated by incubation of whole blood with fluorescein isothiocyanate-labeled, opsonized Escherichia coli bacteria at 37°C with detection of fluorescence of internalized particles as a percentage of positive cells by flow cytometry.|Baseline and 7 days post randomization||||percentage of phagocytosis||Standard Deviation|Mean
1228915|NCT00672854|Secondary|Number of Deaths During Parenteral Nutrition Treatment Between Two Treatment Groups During Hospitalization|Mortality is defined as death occurring during admission, either during the time PN is received or after PN treatment is completed. Death during hospitalization rather than during PN treatment was chosen because many patients who undergo treatment with PN die or develop hospital complications within a period of several days after treatment cessation. The number of deaths between the two groups are compared.|During Parenteral Nutrition (up to 28 days post randomization)||||participants|||Number
1228916|NCT00672854|Secondary|Mean Hospital Blood Glucose (mg/dL) in Diabetic Patients is Measured During Parenteral Nutrition Between the Two Treatment Groups|Mean hospital blood glucose is measured as an indicator for insulin sensitivity. Capillary blood glucose was measured with a glucose meter at bedside during PN infusion. For this study normal blood glucose levels were indicated as 70-200 mg/dL, any blood glucose level < 70 mg/dL is regarded as hypoglycemia and above 200 mg/dL is regarded as hyperglycemia.|During Parenteral Nutrition (up to 28 days post randomization)||||mg/dL||Standard Deviation|Mean
1228959|NCT00672555|Secondary|Cosmetic Score|Patients was sent a postal questionnaire at 1 year, assessing cosmesis with the body image questionnaire adapted from Dunker et al. Cosmetic score resulting form 3 questions: worst 3; best 24.|1 year||||Units on a scale||Standard Deviation|Mean
1228960|NCT00672555|Secondary|Body Image Score|Patients was sent a postal questionnaire at 1 year, assessing body image with the body image questionnaire adapted from Dunker et al. Body image score resulting form 5 questions: worst 5; best 20.|1 year||||Units on a scale||Standard Deviation|Mean
1228917|NCT00672854|Secondary|Mean Change in Plasma Concentration of Cystine in Micromol Per Liter at Baseline, Day 3 and Day 7 Among the Treatment Groups|Mean Plasma concentration of circulating levels of oxidative stress markers like levels of cystine at baseline, day 3, and day 7 are measured and compared between the soybean oil– and olive oil–based parenteral nutrition infusion groups. Levels were measured using iodoacetate to alkylate free thiols, derivatization with dansyl chloride to fluorescently tag amino groups, and high pressure liquid chromatography (HPLC) and fluorescence to separate, detect, and quantify the molecules.|Baseline, Day 3 and Day 7||||micromol per liter||Standard Deviation|Mean
1228918|NCT00672854|Secondary|Mean Plasma Concentration of Tumor Necrosis Factor-alpha, in pg/mL is Measured Between the Two Treatment Groups|Plasma concentration of circulating levels of inflammatory stress markers like tumor necrosis factor-alpha is measured at baseline, day 3, and day 7 among soybean oil– and olive oil–based parenteral nutrition infusion groups. The normal reference values are < or =2.8 pg/mL. Levels were measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the Immulite analyzer.|Baseline, Day 3 and Day 7||||pg/mL||Standard Deviation|Mean
1228919|NCT00672854|Secondary|Mean Plasma Concentration of C-reactive Protein in mg/L at Baseline, Day 3 and Day 7 Among the Treatment Groups Will be Measured|Peripheral blood samples will be analyzed for circulating levels of inflammatory markers markers like plasma C-reactive protein (CRP) at baseline, day 3, and day 7 of soybean oil– and olive oil–based parenteral nutrition infusion and compared. A reading of less than 1 mg/L indicates low risk; a reading between 1 and 2.9 mg/L indicates intermediate risk; a reading greater than 3 mg/L indicates high risk and a reading above 10 mg/L indicates a need for further testing. Since the patients are sick and hospitalized, it is expected that their levels are elevated compared to normal subjects. The levels between the 2 groups are compared to see if there is any difference.Levels were measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the Immulite analyzer.|Baseline, Day 3 and Day 7||||mg/L||Standard Deviation|Mean
1228920|NCT00672854|Secondary|Number of Days Patients Stayed in ICU During Parenteral Nutrition Between Treatment Groups|The mean number of days patients stayed in the intensive care unit between the Intralipid 20% and ClinOleic 20% while they are on parenteral nutrition is calculated and compared|During Parenteral Nutrition (up to 28 days post randomization)||||days||Standard Deviation|Mean
1228921|NCT00672854|Primary|Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay|New nosocomial infections, defined as culture-proven infection including wound, drain, bloodstream, respiratory tract, and urinary tract infections during PN. The presence of nosocomial infections was diagnosed based on standardized Centers for Disease Control (CDC) guidelines for laboratory-confirmed bloodstream infection and did not distinguish catheter-related infections per se. The following daily information was evaluated by the study team for nosocomial infection surveillance: temperature (fever)curve, white blood cell counts, review of daily progress notes in the medical record, daily clinical microbiology laboratory culture data, orders for antimicrobial agents (agent, daily dose, and start/stop times will be recorded), review of all relevant dictated radiographic reports (e.g., chest radiographs, abdominal computer tomography), communication, as needed, with primary physicians and site infectious disease consultants, and use of the CDC guidelines.|2 days after Parenteral Nutrition (up to 28 days post randomization)||||number of nosocomial infections|||Number
1228922|NCT00672841|Primary|Safety and Tolerability of Preemptive Anidulafungin|reported as the Number of Adverse Events Possibly Related to Study Drug|weekly until ICU discharge|Subjects receiving at least 1 dose of anidulafungin were assessed.|||events|||Number
1228923|NCT00672841|Secondary|Incidence of Proven or Probable Invasive Fungal Infection (IFI)|Institution specific criteria were used to establish a diagnosis of proven or probable invasive candidiasis. Other IFIs were classified according to the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria. However, BDG results were not factored into the EORTC/MSG criteria.|Participants were followed until ICU discharge, an average of 17 days|4 subjects in the preemptive therapy were excluded from this analysis. These subjects were treated with empiric antifungal therapy despite repeatedly negative glucan results.|||participants|||Number
1228924|NCT00672841|Secondary|Validate Gene Expression Signatures Predictive of IC||Study Completion, an average of 17 days|Data was not collected for this outcome measure.||||||
1228925|NCT00672841|Primary|Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.|Clinical utility was defined as β-D-glucan test performance. Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis. True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology. Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.|Participants were followed until ICU discharge, an average of 17 days|Two study subjects in the preemptive therapy arm were excluded from the analysis of assay sensitivity and specific due to icteric serum specimens.|||participants|||Number
1228926|NCT00672737|Primary|Experimental Heat-induced Pain - SaO2|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography), on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.|||['C/(mcg/mL)] /%||95% Confidence Interval|Mean
1228927|NCT00672737|Primary|Experimental Cold-induced Pain - SaO2|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography) on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.|||[sec/(mcg/mL)] /%||95% Confidence Interval|Mean
1228928|NCT00672737|Primary|Experimental Heat-induced Pain - IGFBP-1|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in serum level of IGFBP-1, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.|||['C/(mcg/mL)] /pg/mL||95% Confidence Interval|Mean
1228929|NCT00672737|Primary|Experimental Cold-induced Pain - IGFBP-1|The effect of insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated beta (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in the serum level of IGFBP-1, cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.|||[sec/(mcg/mL)] /pg/mL||95% Confidence Interval|Mean
1228930|NCT00672646|Secondary|VAS Pain on Jaw Movement at Rescue Intake|0 = 'No pain' 100 ='Worst pain imaginable'|at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product|Only participants that took rescue medication are included in this analysis.|||Units on a VAS scale||Full Range|Median
1228931|NCT00672646|Secondary|VAS Pain Intensity at Rescue Intake|0 = 'No pain' 100 ='Worst pain imaginable'|at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product|Only participants that took rescue medication are included in this analysis.|||units on a VAS scale||Full Range|Median
1228932|NCT00672646|Secondary|Time to First Meaningful Pain Relief|First meaningful pain relief is the time when the participant’s pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours.|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours||||hour||Inter-Quartile Range|Median
1228933|NCT00672646|Secondary|Time to First Perceptible Pain Relief|First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours.|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours||||hour||Inter-Quartile Range|Median
1228934|NCT00672646|Secondary|Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)|0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately.|Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.||||units on VAS scale||Full Range|Median
1228935|NCT00672646|Primary|Sum of Pain Intensity Difference in Percent (SPID%)|Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours||||percentage of pain intensity change * h||Full Range|Median
1228936|NCT00672633|Secondary|HDL Cholesterol|High Density Lipoprotein Cholesterol|3 months|Intention to Treat|||mg/dL||Standard Error|Mean
1228937|NCT00672633|Secondary|LDL Cholesterol|Low Density Lipoprotein Cholesterol|3 months||||mg/dL||Standard Error|Mean
1228938|NCT00672633|Primary|Fasting Triglycerides|Fasting Triglycerides|3 months|Intention to Treat|||mg/dL||Standard Error|Geometric Mean
1228939|NCT00672620|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
1228940|NCT00672620|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1228961|NCT00672555|Secondary|Patient Overall Satisfaction With Procedure|Follow-up was initiated at 1 year. A postal questionnaire was sent to the patients with a VAS assessing overall satisfaction. Possible values were: lowest: 0; highest 10.|1 year||||Units on a scale||Standard Deviation|Mean
1228962|NCT00672555|Secondary|Reoperations Needed for Treatment of Complication|"All patients were seen at the outpatients clinic at 3 weeks. Follow-up control was initiated at 1 year.~All reoperations that were done were assessed and measured."|1year||||Reoperations|||Number
1228941|NCT00672620|Secondary|Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228942|NCT00672620|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228943|NCT00672620|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)|The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8|"Full analysis set with available data at Baseline; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228944|NCT00672620|Secondary|Clinical Global Impression Scale-Global Improvement Scale|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228945|NCT00672620|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228946|NCT00672620|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
1228947|NCT00672620|Secondary|Percentage of Participants With a Sustained Response in HAM-D24|A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|Baseline to Week 8|Full analysis set with available data.|||percentage of participants|||Number
1228948|NCT00672620|Secondary|Percentage of Responders in HAM-D 24 Total Score by Study Visit|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1228949|NCT00672620|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate.|Baseline and Weeks 1, 2, 4, and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1228963|NCT00672555|Secondary|Minor Complications (Wound Complications)|All wound complications were assessed; part of them being only very minor dehiscences or slight infections. They were assessed in the outpatients clinic at 3 Weeks and in the follow-up control initiated at 1 year. All patients suffering from a wound complication that occurred in the first year were counted.|1 year||||participants|||Number
1229145|NCT00670462|Secondary|Change From Baseline in Energy Intake at 6 Months||Baseline and 6 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."|||kcal/day||Standard Error|Mean
1228950|NCT00672620|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug and had at least 1 valid postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
1228951|NCT00672594|Primary|Change in Proliferation Indices Before and After Treatment|Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %proliferation (Ki67 positive nuclei out of total nuclei) between pre and post treatment will be reported.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis|||Percentage of Ki67 positive nuclei||Standard Deviation|Mean
1228952|NCT00672594|Secondary|Interstitial Fluid Pressure (IFP)|Measure Interstitial fluid pressure (IFP) pre-treatment and during treatment to indirectly measure the effect of Sunitinib malate on transcapillary transport and correlate with other biologic evidence of treatment effect.Eligible patients who sign consent will undergo a baseline transrectal ultrasound (TRUS)-guided measurement of tumor IFP. Participants will then begin treatment with daily oral Sunitinib malate with biweekly monitoring for response and toxicity. After 4 weeks of therapy, patients undergo a repeat TRUS and tumor IFP measurement. Following a 1 to 2 week wash out period, patients undergo prostatectomy with pathologic tissue collection. This will be performed as a means to evaluate whether Sunitinib malate has the ability to decrease tumor IFP, and whether this correlates with other tr|4 years|This was an optional test and no patients chose to participate.||||||
1228953|NCT00672594|Secondary|Difference in Gene Expression Patterns Using Microarray Analysis|Microarray data of 21 specimens from men enrolled who have undergone a prostatectomy and study treatment were compared to data from 21 prostatectomy only specimens. We used previously developed genomic signatures to measure the deregulation of oncogenic pathways built using Bayesian Probit models for ‘metagene’ factors from a singular value decomposition of top differentially expressed genes. A Monte Carlo Markov Chain was used to generate the predicted probabilities of pathway activity in normalized samples. We predicted the activity of these pathways, leading to the generation of probability measures that have previously reflected the state of pathway activity. These probability scores are interpreted as gene expression values to describe pathway activity patterns. A probability near 0 indicates a low chance of pathway activity; a probability near 1 indicates a higher likelihood of activity. Differences (treatment – control) in mean probability for each pathway are reported.|4 years|21 patients had adequate samples for analysis.|||Probability||Standard Deviation|Mean
1228954|NCT00672594|Secondary|Protein Levels and Activation Status of PDGFR in Prostate Cancer Tissue.|We will perform immunohistochemistry staining on snap frozen specimens for endothelial and pericyte cell staining as previously described (42). Frozen prostate tumor biopsies are sectioned at 6μm thickness and fixed with acetone for 10 minutes. Endogenous peroxidase activity is quenched with 3% hydrogen peroxide for 15 min and then blocked with 5% normal serum. The slides are incubated with the primary antibody (1;100) overnight at 4 C°, and washed with PBS. Negative controls will be included by omission of the primary antibody. Biotinylated donkey antimouse antibody (1:1000, v/v) will be applied for 30 min at room temperature, followed by application of ABC kit (Vector Lab, Inc., Burlingame, USA). Slides are again washed in PBS and the color is developed by 5 min incubation with diaminobenzidine (DAB) solution. Slides are then counterstained with hematoxylin. Mean protein levels are presented.|4 years|Due to changes in the field, this test was not performed due to lack of relevance.||||||
1228955|NCT00672594|Secondary|Change in Systemic Parameters Before and After Sunitinib Malate Treatment.|We evaluated candidate biomarkers of this pathway to predict for pharmacodynamic response to Sunitinib malate. In addition, a 7 ml plasma sample was collected at baseline and again at 4 weeks on all patients to assess possible biomarkers of response. Reported is the mean percent change in plasma concentration for each marker between 4 weeks and baseline.|Baseline and 4 weeks|17 patients had adequate measurements at both time points, were on an adequate dose, and took treatment at the correct time points.|||Percent change||Standard Deviation|Mean
1228956|NCT00672594|Secondary|Change in Pathologic (Microvessel Density).|Pathologic changes will be described using immuno-histochemical techniques (assessment of microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the MVD analysis. Results are reported as the difference in pre and post MVD. Units for MVD are number of CD31 cells per high powered field.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis|||CD31 cells/High Powered Field||Standard Deviation|Mean
1228957|NCT00672594|Secondary|Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity|Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to version 4.0 for the purposes of ClinicalTrials.gov reporting.|4 years||||participants|||Number
1228958|NCT00672594|Primary|Change in Apoptotic Indices Before and After Treatment|Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis|||Percentage of TUNEL positive cells||Standard Deviation|Mean
1228964|NCT00672555|Primary|Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure|At 1 year all patients were assessed. Patients with a recurrence of a pilonidal sinus were counted. The result is given as number of patients suffering from a recurrence.|1 year|"Per protocol:~All patients treated in the study period, who gave their informed consent and meet the inclusion criteria, as well did not have any reason for exclusion were enrolled prospectively"|||participants|||Number
1228965|NCT00672490|Secondary|Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28)|"The PANSS Supplemental Aggression Risk subscale score is the sum of 3 standard PANSS items – Excitement, Hostility and Depression – and 3 supplemental PANSS items related to anger – Anger, Difficulty in Delaying Gratification and Affective Lability and ranges from 6 to 42, where 6 is the best and 42 the worst score for the combined scale."|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
1228966|NCT00672490|Secondary|Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42.|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
1228967|NCT00672490|Secondary|Remission Rate (Number of Patients With Clinically Significant Remission)|"The number of patients with clinically significant remission (defined as YMRS total score ≤12) at Day 28 was calculated.~The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. Total score ≤12 indicates remission."|From Baseline to 4 weeks||||Participants|||Number
1228968|NCT00672490|Secondary|Response Rate (Number of Patients With Clinically Response)|The number of patients with clinically response (defined as ≥50% reduction in the YMRS total score from baseline to Day 28) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.|From Baseline to 4 weeks||||Participants|||Number
1228969|NCT00672490|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
1228970|NCT00672490|Secondary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)|The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. The MADRS total score is the sum of all 10 individual-item scores and ranges from 0 to 60.|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
1228971|NCT00672490|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210|Baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
1228972|NCT00672490|Secondary|Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)|The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
1228973|NCT00672490|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)|The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).|Baseline and 4 weeks|Per Protocol Population|||score on a scale||Standard Deviation|Mean
1228974|NCT00672477|Secondary|Time to First Rescue-free Laxation (Following the First Dose of Study Drug).|This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A “rescue free” laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.|14 days|The analysis population included subjects who received ≥ 1 dose of study drug.|||hours||Inter-Quartile Range|Median
1228975|NCT00672477|Primary|The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses|This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A “rescue free” laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.|7 days|The analysis population included subjects who received ≥ 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1228976|NCT00672451|Secondary|Rate of Decline of GFR||2 years|No data collected||||||
1228977|NCT00672451|Primary|Albumin Concentration in Urine||up to 15 months|Data not collected in all participants of the placebo group.|||mg/dL||Standard Deviation|Mean
1228978|NCT00672438|Secondary|Sedation by Patient Report|"Sedation was assessed by measuring cognitive speed and by asking participants to indicate on a 100-mm visual analog scale (VAS) how sedated they felt. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no sedation was experienced. The other extreme end of the scale represents 100, and 100 represents as much sedation as possible. Participants are asked to indicate what point on that continuum best represents their experience of sedation."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
1229030|NCT00671788|Secondary|Overall Survival||Every other cycle up to 5 years|Eligible and treated participants|||months||95% Confidence Interval|Median
1228979|NCT00672438|Secondary|Maximum Drug Disliking|"At the end of an infusion stage participants were asked, What was the maximum that you disliked the drug at any moment (VAS)? (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the most they disliked the drug experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
1228980|NCT00672438|Secondary|Maximum Drug Liking|"At the end of an infusion stage participants were asked, What was the maximum that you liked the drug at any moment (VAS)? (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the their experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
1228981|NCT00672438|Secondary|Average Drug Liking|"At the end of an infusion stage participants were asked, How much did you like the drug on average (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the their experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
1228982|NCT00672438|Secondary|Maximum Pruritis|"At the end of an infusion stage participants were asked to rate the maximum severity of pruritis on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no pruritis experienced. The other extreme end of the scale represents 100, and 100 represents as much pruritis as possible. Participants are asked to indicate what point on that continuum best represents their maximun experience of pruritis."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
1228983|NCT00672438|Secondary|Average Pruritis|"At the end of an infusion stage participants were asked to rate the average severity of pruritis on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no pruritis experienced. The other extreme end of the scale represents 100, and 100 represents as much pruritis as possible. Participants are asked to indicate what point on that continuum best represents their average experience of pruritis."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
1228984|NCT00672438|Secondary|Maximum Nausea|"At the end of an infusion stage participants were asked to rate the maximum severity of nausea on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no nausea experienced. The other extreme end of the scale represents 100, and 100 represents as much nausea as possible. Participants are asked to indicate what point on that continuum best represents their maximum experience of nausea."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
1228985|NCT00672438|Secondary|Average Nausea|"At the end of an infusion stage participants were asked to rate the average severity of nausea on a 100-mm visual analog scale (VAS) anchored by the words “not at all” and “as much as possible.” This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no nausea experienced. The other extreme end of the scale represents 100, and 100 represents as much nausea as possible. Participants are asked to indicate what point on that continuum best represents their average experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
1228986|NCT00672438|Secondary|Sedation|Sedative opioid effects were assessed with the trail-making test (TMT) (Angst et al., 2004; Oswald and Roth, 1987). The TMT is a paper-and pencil test consisting of 4 different matrices listing numbers 1–90 in a 9 × 10 format. Subsequent numbers are located in neighboring rows or columns. Matrices were allocated randomly. Subjects had to connect numbers 1–90 as quickly as possible and the time to completion was recorded.|The trail making test was performed at training prior to study procedures, at baseline, and during each of the infusions.|All participants were included for analysis.|||Time in seconds||Inter-Quartile Range|Median
1228987|NCT00672438|Primary|Transcutaneous Partial Pressure of Carbon Dioxide|Partial pressure of transcutaneous carbon dioxide (CO2) was measured with aid of a pO2/pCO2-electrode (Perimed Inc., North Royalton, OH) mounted to the anterior chest wall.|Measured continuously throughout the study session ~ 5 hours|All participants were included for analysis.|||mmHg||Inter-Quartile Range|Median
1228988|NCT00672438|Primary|Respiratory Rate|Breaths per minute counted by direct observation and additionally recorded / external electronic monitoring.|Measured throughout the study session ~ 5 hours|All participants were included for analysis.|||Breaths per minute||Inter-Quartile Range|Median
1228989|NCT00672438|Primary|Cold Pain Tolerance|"Time in seconds~Sensitivity to cold-pressor pain was tested by asking subjects to immerse their hand up to the wrist in ice water (1–2 C) continuously re-circulated within a 12-L container with the palm of the hand in full contact with the bottom of the container.They were asked to remove their hand from the water bath when it was no longer tolerable - reported as pain tolerance."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.|||Seconds||Inter-Quartile Range|Median
1229068|NCT00671437|Secondary|Determine the Overall Disease Control Rate by RECIST Criteria as Assessed by CT and Clinical Examination and to Determine the TTP and the OS With Cetuximab Therapy||Every 8 weeks until death (approximately 5 years)|This was not analyzed due to the lack of evidence-based medicine showing an overall survival benefit of cetuximab monotherapy in this type of cancer.||||||
1228990|NCT00672438|Primary|Cold Pain Threshold|"Time in seconds~Sensitivity to cold-pressor pain was tested by asking subjects to immerse their hand up to the wrist in ice water (1–2 C) continuously re-circulated within a 12-L container with the palm of the hand in full contact with the bottom of the container.They were asked to indicate the onset of pain - reported as pain threshold."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.|||Seconds||Inter-Quartile Range|Median
1228991|NCT00672438|Primary|Heat Pain Threshold|"Degrees Centigrade~Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin at the volar forearm. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.|||degrees centigrade||Inter-Quartile Range|Median
1228992|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Satiated Day|"Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following smoking as usual|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.|||percentage of signal change||Standard Deviation|Mean
1228993|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Abstinent Day|"Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.|||percentage of signal change||Standard Deviation|Mean
1228994|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Abstinent Day|"Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.|||percentage of signal change||Standard Deviation|Mean
1228995|NCT00672256|Primary|Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Satiated Day|"Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following smoking as usual|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.|||percentage of signal change||Standard Deviation|Mean
1228996|NCT00672243|Secondary|Number of Participants Experiencing a ≥ Grade 3, Treatment-related, Non-hematologic Toxicity.|Number of participants experiencing a ≥ grade 3, treatment-related, non-hematologic toxicity.|2 years|Intent to treat (ITT)|||participants|||Number
1228997|NCT00672243|Secondary|Best Radiographic Response|Best radiographic response per modified Macdonald criteria. Complete response: disappearance of all enhancing tumor, no new lesions, and no steroids or only maintenance doses. Partial response: ≥ 50% reduction in the products of the perpendicular diameters of all enhancing lesions, no new lesions, & steroids must be at a stable/decreasing dose. Stable disease: does not qualify for complete or partial response or progression & is stable clinically. Progression: ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|2 years|Intent to treat (ITT)|||participants|||Number
1228998|NCT00672243|Secondary|Median Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|2 years|Intent to treat (ITT)|||weeks||95% Confidence Interval|Median
1228999|NCT00672243|Secondary|Median Progression Free Survival (PFS)|Time in weeks from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|2 years|Intent to treat (ITT)|||weeks||95% Confidence Interval|Median
1229146|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 6 months|Baseline and 6 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."|||kcal/wk||Standard Error|Mean
1229000|NCT00672243|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|6 months|Intent to treat (ITT)|||percentage of participants||95% Confidence Interval|Number
1229001|NCT00672204|Primary|The Proportion of Insulin-independent Subjects With Full Islet Graft Function|"Islet transplant recipients will be considered insulin-independent with full islet graft function if they are able to titrate off insulin therapy for at least 1 week and all of the following criteria are met:~HbA1c < 7.0% or a ≥2.5% decrease from baseline;~fasting capillary glucose level should not exceed 140 mg/dL (7.8 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 7 times in a seven day period);~2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 21 times in a seven day period);~fasting serum glucose level ≤126 mg/dL (7.0 mmol/L); if the fasting serum glucose level is >126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements;~evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥0.5 ng/mL (0.16 nmol/L)."|1 year following the first islet transplant|Raptiva was removed from market after 3 subjects were transplanted|||participants|||Number
1229002|NCT00672178|Primary|Number of Participants With Overall Complete and Partial Response (CR+PR)||8 weeks|||||||
1229003|NCT00672139|Primary|Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.|This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.|10 weeks|The analysis population included subjects who received study drug and had laxation data and drug administration data. Two subjects in the 12 mg/day group had no drug administration data and were not included in efficacy analyses (but they were included in baseline characteristics and safety analyses).|||Number of laxations||Standard Deviation|Mean
1229004|NCT00672100|Secondary|Functional Outcome - Simple Shoulder Test (SST)|At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed.|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1229005|NCT00672100|Secondary|"Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful"|"Participants were asked to rate the helpfulness of their infusion:~extremely harmful~harmful~neutral~not harmful, but not helpful~helpful~extremely helpful"|at 24 and 48 hours after discharge from the hospital||||percentage of participants|||Number
1229006|NCT00672100|Primary|Change in Diaphragmatic Displacement From Baseline to Post-surgery|Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.|Baseline, Post anesthesia care unit (PACU) - within 8 hours||||percent change||95% Confidence Interval|Mean
1229007|NCT00672100|Primary|Pain Measurements Via Numeric Pain Rating Scales (NRS)|Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)|Discharge, 24 h, 48h, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1229008|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - VEGFR-2|Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC score is the product of the percentage of cancer cells positive for VEGFR-2 multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.|1 year||||IHC Expression Score||Full Range|Median
1229009|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Vascular Endothelial Growth Factor (VEGF)|Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC expression score is the product of the percentage of cancer cells positive for VEGF multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.|1 year||||IHC Expression Score||Full Range|Median
1229010|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Six tumors had an insufficient measurement for analysis.|||participants|||Number
1229011|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Four tumors had an insufficient measurement for analysis.|||participants|||Number
1229012|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis.|||participants|||Number
1229013|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - EGFR vIII|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit.|||participants|||Number
1229147|NCT00670462|Primary|Change in Body Weight||Baseline to18 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."|||kg||Standard Deviation|Mean
1229014|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis|||participants|||Number
1229015|NCT00671970|Secondary|Pharmacokinetics of Erlotinib: AUC|Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Area under the Curve (ng/mL.h) (AUC) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib|Day 1 and 42 of Dosing Erlotinib|22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib|||ng/ml.h||Full Range|Median
1229016|NCT00671970|Secondary|Pharmacokinetics of Erlotinib: Cmax|Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Maximum Concentration (ng/mL) (Cmax) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib|Day 1 and 42 of Dosing Erlotinib|22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib|||ng/ml||Full Range|Median
1229017|NCT00671970|Secondary|Radiographic Response|"The number of participants with complete or partial response as determined by the following criteria:~Complete response (CR): Disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses.~Partial response (PR): Greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose."|Patients were followed for the duration of the study, with a median follow-up of 103 weeks for grade III participants and 141.8 weeks for grade IV participants||||participants|||Number
1229018|NCT00671970|Primary|6 Month Progression-free Survival|The proportion of patients alive and progression free at 6 months|6 months||||proportion of participants||95% Confidence Interval|Number
1229019|NCT00671931|Primary|Motor Evoked Potential Amplitude|The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.|baseline, 30 minutes||||participants|||Number
1229020|NCT00671918|Secondary|Reverse Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.|||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
1229021|NCT00671918|Primary|Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/nonlymphatic) and pathology status (presence/absence of tumor cells) was confirmed.|||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
1229022|NCT00671879|Secondary|Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)|Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.|baseline and day +14|Intent to Treat(ITT) population|||marked statements||Standard Error|Least Squares Mean
1229023|NCT00671879|Primary|Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale|on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.|baseline to 14 days|intent to treat(ITT) population least square mean(LSMEAN, LSMEAN) diff vs Placebo|||mm||Standard Deviation|Least Squares Mean
1229024|NCT00671853|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A)|The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe|Week 0 - Week 8||||units on a scale||Standard Deviation|Mean
1229025|NCT00671853|Secondary|Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction.|Week 0 - Week 8||||units on a scale||Standard Deviation|Mean
1229026|NCT00671853|Secondary|Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score|"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.~1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."|Week 0 - Week 8||||units on a scale||Standard Deviation|Mean
1229027|NCT00671853|Secondary|Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7.|Week 0 - Week 8||||Participants|||Number
1229028|NCT00671853|Secondary|Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.|Week 0 - Week 8||||participants|||Number
1229029|NCT00671853|Primary|Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.|Week 0 - Week 8||||units on a scale||Standard Deviation|Mean
1229031|NCT00671788|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated participants|||months||95% Confidence Interval|Median
1229032|NCT00671788|Secondary|Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0||Every cycle during treatment|||||||
1229033|NCT00671788|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
1229034|NCT00671788|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.||||percentage of participants||90% Confidence Interval|Number
1229035|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Burning/Stinging|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)|||participants|||Number
1229036|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Dryness|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)|||participants|||Number
1229037|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Scaling|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)|||participants|||Number
1229038|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Erythema|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)|||participants|||Number
1229039|NCT00671749|Secondary|Global Assessment of Improvement From Baseline||12 weeks||||participants|||Number
1229040|NCT00671749|Secondary|Global Severity Assessment Success|Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear|6 and 12 weeks||||participants|||Number
1229041|NCT00671749|Primary|Percent Change From Baseline in Total Lesion Counts||6 and 12 weeks||||Percent Change||Standard Deviation|Mean
1229042|NCT00671723|Secondary|Rate of Extubation|percentage of patient who were extubated at day 7|7 days||||Participants|||Count of Participants
1229043|NCT00671723|Primary|Change in the Chest X-ray Atelectasis Score|"Each CXR was assigned an atelectasis score.(*) The absence or presence of contralateral hyperinflation was marked as 0 or 1 point, respectively. The absence or presence of mediastinal shift was scored as 0 or 1, respectively. Atelectasis was scored for each lobe. A partial atelectasis of one lobe was scored as one point, whereas complete atelectasis of a lobe was marked as two points. The distinction between infiltrate and atelectasis as well as the total scoring was done by the interpreting radiologist. These results were summed for each CXR. The score range from 0 to 10 with 0 indicates no atelectasis,higher value indicates progressively more atelectasis.~*Hendriks T, de Hoog M, Lequin MH, Devos AS, and Merkus PJ: DNase and atelectasis in non-cystic fibrosis pediatric patients. Crit Care. 2005;9:R351–R356."|Baseline(Day 0) to Day 7||||units on a scale||Standard Deviation|Mean
1229044|NCT00671671|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. Results are reported for Cohort B at Day 3. Due to limited sampling, time interval over which plasma concentrations were measured after final dose was too short relative to projected t1/2. Therefore, t1/2 estimates were not calculated on Day 10.|||hours||Standard Deviation|Mean
1229478|NCT00667563|Primary|Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0|Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients|52 weeks from study entry|Intent-to-treat|||Grade 3/4 adverse events per 100 patient||95% Confidence Interval|Number
1229045|NCT00671671|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||hours||Full Range|Median
1229046|NCT00671671|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||ng/mL||Standard Deviation|Geometric Mean
1229047|NCT00671671|Secondary|Plasma Concentration at The End of Dosing Interval (Ctau)|Ctau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A|PP analysis set. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. The Ctau on Day 1 was not necessary for interpretation of the PK data and hence was not analyzed.|||ng/mL||Standard Deviation|Geometric Mean
1229048|NCT00671671|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are reported for Cohort B at Day 3. Due to differences in sampling schedules between Cohort A and B, AUC (0 - ∞) data was not considered meaningful and hence were not analyzed on Day 10 for Cohort A.|||ng*hr/mL||Standard Deviation|Geometric Mean
1229049|NCT00671671|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration (AUClast). AUClast was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm, respectively. Given the sampling schedule on Day 1 and Day 10 for 450 mg dose in Cohort A, AUClast data was not considered meaningful and hence were not analyzed.|||ng*hr/mL||Standard Deviation|Geometric Mean
1229050|NCT00671671|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. AUCtau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A|Per Protocol (PP) analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the pharmacokinetic (PK) parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1229051|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.|Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B|MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.|||log10 IU/mL||Standard Deviation|Mean
1229052|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.|Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B|FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.|||log10 IU/mL||Standard Deviation|Mean
1229053|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as the average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).|Baseline, Day 4|MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.|||log10 IU/mL||Standard Deviation|Mean
1229069|NCT00671437|Secondary|Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Overall Survival With Cetuximab Therapy||Every 8 weeks until death (approximately 5 years)|The small dataset precluded an adequate analysis of overall survival relationships due to varying co-variates such as post-progression therapies, ECOG PS, co-morbidities.||||||
1229054|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).|Baseline, Day 4|FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.|||log10 IU/mL||Standard Deviation|Mean
1229055|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).|Baseline, Day 11|Modified Analysis Set (MAS): a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.|||log10 IU/mL||Standard Deviation|Mean
1229056|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (lower limit of quantification [LLOQ] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).|Baseline, Day 11|Full Analysis Set (FAS) included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.|||log10 IU/mL||Standard Deviation|Mean
1229057|NCT00671606|Primary|Sentinel Node Identification Rate|Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.|15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes|Analysis was per protocol; no analysis conducted due to low detection rate.||||Participants||
1229058|NCT00671554|Secondary|Tumor Response Measured by RECIST Criteria and Progression-free Survival.|CT scans for disease assessment occurred at three month intervals. If partial or complete responses were observed confirmation scans were performed within four weeks. Patients were followed for 18 months post study completion. All three participants recieved at least one vaccine, and all participants had progression of disease prior to the 18 month followup visit.|From first vaccine to 18 months after the last injection||||participants|||Number
1229059|NCT00671554|Primary|Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.|Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.|From first vaccine to 18 months after the last injection||||participants|||Number
1229060|NCT00671528|Secondary|Number of Days Required to Achieve Total Remission|The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.|Up to 28 days||||Days|||Number
1229061|NCT00671528|Primary|Percent Improvement of Individually Measured Signs of the Disease|"Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator.~The following scale was used:~Cure- Complete remission~> 75% reduction: Marked improvement~50-75% reduction: Moderate improvement~25-50% reduction: Slight improvement~<25% reduction: Ineffectiveness~Worsening of signs & symptoms"|Days 1 (prior to start of treatment), 8, 15, 21, and 28.|Due to lack of participant recruitment and therefore study termination, no analyses were performed.||||||
1229062|NCT00671515|Secondary|Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. Typically cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.|Week 0-Week 12||||units on a scale||Standard Deviation|Mean
1229063|NCT00671515|Primary|Change in Depression Symptom Severity From Baseline to Study Endpoint|Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome|Week 0 - Week 12||||Units on a scale||Standard Deviation|Mean
1229064|NCT00671502|Secondary|Adverse Event Assessment|the number of adverse events reported during the course of the study as reported by the participants|up to 21 days|||||||
1229065|NCT00671502|Secondary|Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)||up to 14 days|||||||
1229066|NCT00671502|Primary|Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)|the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit|up to 14 days|efficacy analyses based on ITT population. LOCF used to impute missing data. To detect a 14% difference between the carisoprodol and placebo treated subjects, 196 ITTsubjects per group (alpha level 0.025,power 80%).Assuming 15% dropout rate, 226 subjects per group were needed.A total of678 subjects were required to achieve 584 ITT subjects.|||mm||95% Confidence Interval|Least Squares Mean
1229067|NCT00671437|Secondary|Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck||30 days after end of study treatment (approximately 1 year after start of treatment)||||participants|||Number
1229512|NCT00667420|Primary|Safety and Tolerability|Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy|after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)||||participants|||Number
1229070|NCT00671437|Secondary|Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Time to Progression (TTP) With Cetuximab Therapy|Cetuximab was continued after cycle 1 in patients with disease control(PR/SD) by CT, even if the FDG-PET/CT showed PMD. Cetuximab was discontinued after cycle 1 in patients with progression by CT.|Every 8 weeks until disease progression (up to 1 year)||||days||95% Confidence Interval|Median
1229071|NCT00671437|Secondary|Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination||Every 8 weeks until disease progression (up to 1 year)||||participants|||Number
1229072|NCT00671437|Secondary|Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination|Agreement in treatment decision using CT and FDG-PET/CT. Agreement in treatment decision occurred when tumor response by CT and FDG-PET/CT resulted in the same decision in treatment (continue cetuximab due to disease control or stop cetuximab due to progression). Disagreement in treatment decision occurred when tumor response assessment by CT and FDG-PET/CT resulted in different treatment decisions.|After 8 weeks of treatment||||participants|||Number
1229073|NCT00671437|Secondary|Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination|A generalization of McNemar’s test was used to test for concordance of response(partial, stable or progression) by CT and by FDG-PET/CT.|After 8 weeks of treatment||||participants|||Number
1229074|NCT00671437|Secondary|Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan|Definitions of anatomic response by RECIST for CT scan included: complete response(CR)—disappearance of all target and non-target lesions and no new lesions; partial response(PR)—at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter, persistence of one or more non-target lesions, and no new lesions; stable disease (SD)—neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started, persistence of one or more non-target lesions, and no new lesions; progressive disease(PD)—at least a 20% increase in the sum of the longest diameter of target lesions recorded since the treatment started, appearance of one or more new lesions/unequivocal progression of existing non-target lesions.|After 8 weeks of treatment||||participants|||Number
1229075|NCT00671437|Secondary|Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT|Definitions of metabolic response by FDG-PET/CT included: complete metabolic response(CMR)—complete resolution of all metabolically active target and non-target lesions, and no new lesions; partial metabolic response(PMR)—20% or greater decrease in SUV of target lesions with or without decrease in number/size of non-target lesions, and no new lesions; progressive metabolic disease(PMD)—one or more new lesions, 20% or greater increase in SUV of target lesions and/or unequivocal increase in FDG activity of non-target lesions; and stable metabolic disease(SMD)—not qualifying as CMR, PMR, or PMD.|After 8 weeks of treatment||||participants|||Number
1229076|NCT00671437|Primary|SUVmax at up to Three Target Tumor Sites as Assessed by FDG-PET/CT of Eligible Patients at Baseline and Then After Eight Weeks of Treatment With Cetuximab.|"Eight weeks of treatment is equal to one cycle of treatment.~FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response."|Baseline and after 8 weeks of treatment||||SUVmax||95% Confidence Interval|Mean
1229077|NCT00671437|Primary|Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT|FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response.|Baseline and after 8 weeks of treatment||||percentage of change||Full Range|Mean
1229078|NCT00671177|Secondary|Patient Satisfaction|Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).|At the time of the procedure||||units on a scale||Full Range|Mean
1229079|NCT00671177|Secondary|Time to Cecum||At the time of the procedure||||minutes||Standard Deviation|Mean
1229080|NCT00671177|Primary|Colonoscopy Success With Minimal Sedation||At the time of the procedure||||Participants|||Count of Participants
1229081|NCT00671060|Primary|Successful Expulsion of Fetus and Placenta Within 48 Hours||48 hours|One woman assigned to the 200μg arm was determined to be ineligible after enrollment due to a gestational age less than 14 weeks. She was not included in the analysis. One woman in the 100mcg arm was withdrawn from the study due to preeclampsia. She was included in the analysis as a failed induction.|||participants|||Number
1229082|NCT00671034|Secondary|Relationship Between PK and Presence of Antibodies|Patients with presence of Antibodies.|Day 29 of consolidation|These data will never be collected.||||||
1229112|NCT00670774|Secondary|Number of Patients Requiring Splenectomy|A splenectomy is a surgical operation involving removal of the spleen. Splenectomy was performed for severe AMR in the setting of a rising serum creatinine (usually >2.0) and a rising serum DSA level despite daily plasma exchange treatments.|1 year|10 subjects discontinued early (<1 year) according to protocol because they had a B flow cytometric crossmatch (BFMX) <200.|||Participants|||Count of Participants
1229083|NCT00671034|Secondary|Toxicities During Post Induction Intensification Therapy (All Grades)|The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events.|Up to 5 years|Patients who had data collected. International normalized ratio (INR). Activated partial thromboplastin (APT)|||Percentage of participants|||Number
1229084|NCT00671034|Secondary|Immunogenicity|Number of Patients with Positive Immunogenicity tests|25 Days Post-dose (Day 29)|Patients who had data collected.|||Participants|||Count of Participants
1229085|NCT00671034|Secondary|Plasma and CSF Concentrations of Asparagine in ug/ml|The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar.|25 Days Post-dose (Day 29)|Patients who had data collected.|||ug/mL||Standard Deviation|Mean
1229086|NCT00671034|Secondary|Asparaginase Level|The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar|Days 4, 15, 22 and 29 of Induction|Patients who had data collected.|||percentage of patients||95% Confidence Interval|Number
1229087|NCT00671034|Secondary|Percentage of Participants With Event-free Survival (EFS)|Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free.|5 Years||||Percentage of participants||95% Confidence Interval|Number
1229088|NCT00671034|Secondary|Percentage of Participants With Complete Remission at the End of Induction|Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow)|End of induction (Day 29)|Patients who had data collected|||Percentage of participants||95% Confidence Interval|Number
1229089|NCT00671034|Secondary|Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction|Percentage of participants with Negative MRD (MRD<0.01%).|End of induction (Day 29)|Patients who had data collected.|||Percentage of participants||95% Confidence Interval|Number
1229090|NCT00671034|Secondary|Pharmacodynamics (PD)|Plasma Asparaginase Concentration During consolidation and induction.|Day 29 of consolidation and induction|Patients who had data collected|||mIU/mL||Standard Deviation|Median
1229091|NCT00671034|Primary|Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)|Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half.|Post Day 29 of Induction and Post Day 22 of Consolidation|Analysis restricted to patients who had PK data collected|||hours||Standard Deviation|Mean
1229092|NCT00670982|Secondary|Progression-free Survival|Median progression free survival measured in months|3 years|Median time from registration to progression of disease|||months||Full Range|Median
1229093|NCT00670982|Secondary|Objective Response Rate|Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and assessed by computed tomography.Complete response (CR), disappearance of all target and non-target lesions; partial response (PR), >/=30% decrease in the sum of longest dimensions of target lesions; objective response rate = CR + PR.|1 year|Confirmed objective response rate|||percentage of participants|||Number
1229094|NCT00670982|Primary|Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.|Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.|1 year|What percentage of patients were still on study and without progression at one year|||percentage of participants||95% Confidence Interval|Number
1229095|NCT00670956|Secondary|Survival at One-month Between Study and Control Groups.|Status of neonate survival 30 days after delivery|30 days after delivery (up to approximately 24 weeks post-enrollment)||||participants|||Number
1229096|NCT00670956|Secondary|Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)||Baseline, Delivery (up to approximately 20 weeks post-enrollment)|Study was terminated without enrollment to control arm; therefore, no comparison was made||||||
1229097|NCT00670956|Primary|Incidence of Hydrops Fetalis||Delivery, up to approximately 20 weeks post-enrollment|Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm|||participants|||Number
1229098|NCT00670930|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy||78 weeks|The safety population consisted of all patients in the intent to treat (ITT) population that received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Number
1229099|NCT00670930|Secondary|Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.|||micrometer(µm)||Standard Deviation|Mean
1229113|NCT00670774|Secondary|Number of Patients Developing High DSA Levels at Less Than or Equal to 3 Months|High DSA levels were defined as B flow cross match channel shift >350 at any time point in the first 3 months.|3 months||||Participants|||Count of Participants
1229513|NCT00667394|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|45 months||||Participants|||Number
1229100|NCT00670930|Secondary|Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.|||cells/mm^2||Standard Deviation|Mean
1229101|NCT00670930|Secondary|Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.|||cells/mm^2||Standard Deviation|Mean
1229102|NCT00670930|Primary|Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)|The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Patients with both baseline and af end of week 78 data in each category have been reported.|||cells/mm^2||Standard Deviation|Mean
1229103|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Right Amygdala|"Mu-opioid binding potential in right amygdala measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and 4 months||||ratio||Standard Deviation|Mean
1229104|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Left Amygdala|"Mu-opioid binding potential in left amygdala measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)"|Baseline and after 4 months||||ratio||Standard Deviation|Mean
1229105|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Right Nucleus Accumbens|"Mu-opioid binding potential in right nucleus accumbens measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and after 4 months|All 7 PCOS women were included, 2 controls were excluded because repeat baseline HOMA2-IR %S was <80%.|||ratio||Standard Deviation|Mean
1229106|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Left Nucleus Accumbens|"Mu-opioid binding potential in left nucleus accumbens is measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and after 4 months|All 7 PCOS women completed the protocol and were included. 5 of 7 controls were included in this analysis. 2 controls were excluded from analysis because repeat baseline OGTT showed HOMA %S of <80%.|||ratio||Standard Deviation|Mean
1229107|NCT00670774|Secondary|Transplant Glomerulopathy Incidence at One Year|Transplant glomerulopathy is a morphologic lesion of renal allografts that is characterized histologically by duplication and/or multilayering of the glomerular basement membrane. It is widely accepted as a manifestation of chronic antibody-mediated rejection (AMR). This is determined by histology.|1 year|10 subjects discontinued early (<1 year) according to protocol because they had a B flow cytometric crossmatch (BFMX) <200. An additional subject did not have a biopsy done at one year.|||Participants|||Count of Participants
1229108|NCT00670774|Secondary|Number of Subjects Receiving Posttransplant Plasma Exchange (PE)|Plasma exchange is needed when there is poor kidney functioning, and donor specific alloantibody (DSA) is high|up to one year||||Participants|||Count of Participants
1229109|NCT00670774|Secondary|Number of Subjects With Graft Survival at One Year|Graft survival means the kidney has not been rejected by the body.|1 year|10 subjects discontinued early (<1 year) according to protocol because they had a B flow cytometric crossmatch (BFMX) <200.|||Participants|||Count of Participants
1229110|NCT00670774|Secondary|Length of Follow-up|Following the completion of dosing, subjects were to return for follow-up visits at 3 and 6 months post transplant to obtain biopsies and collect follow-up data. Subjects who continued the drug for 12 months were to receive their final assessment at 15 months.|up to 15 months||||months||Standard Deviation|Mean
1229111|NCT00670774|Secondary|Graft Dysfunction in First Month Post Transplant|(Maximum serum creatinine-nadir serum creatinine)|1 month||||mg/dL||Standard Deviation|Mean
1229143|NCT00670462|Secondary|Waist-to-hip Ratio at Baseline||baseline||||ratio||Standard Error|Mean
1229144|NCT00670462|Secondary|Blood Pressure||baseline, 6, 12, 18, and 30 months|||||||
1229114|NCT00670774|Primary|Number of Subjects With Antibody-Mediated Rejection (AMR) in the First 3 Months After Living Donor Kidney Transplantation|AMR can cause acute graft loss or shorten allograft survival. Renal allograft biopsies were obtained percutaneously using ultrasound guidance processed for light microscopy and immunofluorescence for peritubular capillary staining for C4d. All biopsies were reviewed by a pathologist in a blinded fashion. AMR was diagnosed using standard Banff criteria in combination with graft dysfunction (increase in serum creatinine >/=0.3 mg/dL over nadir.)|up to 3 months||||Participants|||Count of Participants
1229115|NCT00670748|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|66 months and 10 days||||participants|||Number
1229116|NCT00670748|Secondary|Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells|Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR). This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month post treatment||||participants|||Number
1229117|NCT00670748|Primary|Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|Approximately 3 years||||participants|||Number
1229118|NCT00670709|Primary|Quantitative Electroencephalography Absolute Alpha Power.|Absolute power in the alpha frequency as measured by quantitative electroencephalography|baseline EEG||||microvolts squared||Standard Deviation|Mean
1229119|NCT00670709|Primary|Quantitative Electroencephalography Absolute Delta Power.|Absolute power in the delta frequency as measured by quantitative electroencephalography|baseline- one time point||||microvolts squared||Standard Deviation|Mean
1229120|NCT00670631|Secondary|Overall Survival Will be Compared to a Historical Control (UARK 98-026, TT2)as a Secondary Outcome.||After 204 patients have been enrolled|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.||||||
1229121|NCT00670631|Primary|In Assessing Patient Safety, we Will Examine Treatment Toxicity Related Mortality and SAEs. Historical Study Results Indicate That a Mortality Rate of Greater Than 10% is Not Acceptable in This Population, Nor is an SAE Rate of Greater Than 15%.||Interim analyses for safety will be performed after 20, 100, 200, and 300 patients have been enrolled.|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.||||||
1229122|NCT00670631|Primary|To Determine Whether, in Comparison to TT II, the Median EFS Can be Increased From 4.8 Years to 6.2 Years, Which Represents an Increase in Median EFS of Approximately 30%||After enrollment of 204 subjects is completed|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.||||||
1229123|NCT00670540|Secondary|Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)||at 3 years||||percentage of participants||95% Confidence Interval|Number
1229124|NCT00670540|Secondary|Percentage of Participants Who Developed Cancer Onset||at 3 years||||percentage of participants||95% Confidence Interval|Number
1229125|NCT00670540|Secondary|Percentage of Participants Who Died From Any Cause||at 3 years||||percentage of participants||95% Confidence Interval|Number
1229126|NCT00670540|Secondary|Percentage of Participants Who Developed Cardiovascular Events||at 3 years||||percentage of participants||95% Confidence Interval|Number
1229127|NCT00670540|Secondary|Percentage of Participants With Treatment Anticoagulant Prescribed||after inclusion||||percentage of participants||95% Confidence Interval|Number
1229128|NCT00670540|Secondary|Percentage of Participants Who Developed Major Bleeding Events||at 3 years||||percentage of participants||95% Confidence Interval|Number
1229129|NCT00670540|Primary|Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)|new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.|at 3 years||||percentage of participants||95% Confidence Interval|Number
1229130|NCT00670462|Secondary|Waist-to-hip Ratio at 30 Months||30 months||||ratio||Standard Error|Mean
1229131|NCT00670462|Secondary|Waist-to-hip Ratio at 18 Months||18 months||||ratio||Standard Error|Mean
1229132|NCT00670462|Secondary|Waist-to-hip Ratio at 12 Months||12 months||||ratio||Standard Error|Mean
1229133|NCT00670462|Secondary|Waist-to-hip Ratio at 6 Months||6 months||||ratio||Standard Error|Mean
1229134|NCT00670462|Secondary|Change From Baseline in Energy Intake at 18 Months||18 months||||kcal/day||Standard Error|Mean
1229135|NCT00670462|Secondary|Change From Baseline in Energy Intake at 12months||12 months||||kcal/day||Standard Error|Mean
1229136|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 18 months|18 months||||kcal/wk||Standard Error|Mean
1229137|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 12 months|12 months||||kcal/wk||Standard Error|Mean
1229138|NCT00670462|Secondary|Mood State||baseline, 6, 12, 18, and 30 months|||||||
1229139|NCT00670462|Secondary|Triglycerides||baseline, 6, 12, 18, and 30 months|||||||
1229140|NCT00670462|Secondary|HDL||baseline, 6, 12, 18, and 30 months|||||||
1229141|NCT00670462|Secondary|Insulin||baseline, 6, 12, 18, and 30 months|||||||
1229142|NCT00670462|Secondary|Blood Glucose||baseline, 6, 12, 18, and 30 months|||||||
1229148|NCT00670449|Secondary|Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score|Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.|Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. • The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)|||Units on a scale||Standard Deviation|Mean
1229149|NCT00670449|Secondary|Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment|Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.|Baseline to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)|||Percentage of patients||95% Confidence Interval|Number
1229150|NCT00670449|Secondary|Percentage of Patients Relapse-free at the End of the Study|Patients who did not experience any relapses confirmed by a neurologist during the study were regarded as relapse-free patients.|Baseline to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010).(approximately 22 months before study completion)|||Percentage of patients||95% Confidence Interval|Number
1229151|NCT00670449|Secondary|Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses|The ARR was defined as the total number of relapses for all patients in the treatment arm / total number of days in the study for all patients in the treatment arm for the specific period of time × 365.25. General definition of relapse: Appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (< 37.5°C) or infection. A relapse was to be confirmed by a neurologist trained on the Expanded Disability Status Scale (EDSS). A relapse must be accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on 2 different Functional Systems (FS) of the EDSS or 2 points on 1 of the FS (excluding Bowel/Bladder or Cerebral FS).|Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)|||Relapses per year|||Number
1229152|NCT00670449|Secondary|Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions|To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of new or newly enlarged T2 weighted MRI lesions were counted and recorded. New lesions were identified by comparing each lesion with previous scans. Lesions expanding through several slices were counted as only 1 lesion.|Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years)|Core full analysis set(FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. Study became open-label with all patients receiving FTY720 0.5 mg/day. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb-2010). (approximately 22 months before study completion)|||Percentage of patients|||Number
1229153|NCT00670449|Primary|Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions|To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of Gd-enhanced T1 weighted MRI lesions were counted and recorded. Lesions expanding through several slices were counted as only 1 lesion.|Months 6, 9, 12, 18, 24, 36, and 48|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)|||Percentage of patients|||Number
1229154|NCT00670306|Primary|IPSS Change From Baseline|International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26|Baseline and Week 26|Intention to treat (ITT) analysis with Last Observation Carried Forward (LOCF) imputation technique|||Units on a scale||Standard Deviation|Mean
1229527|NCT00667355|Secondary|Mean Change From Baseline in Chest Expansion|Chest expansion is the difference in centimeters between full expiration and full inspiration, measured at the 4th inter-costal space. An increase in chest expansion represents improvement.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||cm||95% Confidence Interval|Mean
1229155|NCT00670267|Secondary|Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline|In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline to end of study (105 days)||||units on a scale||Standard Deviation|Mean
1229156|NCT00670267|Secondary|Percent Change in FEV1% Predicted From Baseline to End of Study||Baseline to end of study (105 days)||||percent change in FEV1% predicted||Standard Deviation|Mean
1229157|NCT00670267|Secondary|Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)|Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999).|Baseline to end of study (105 days)|Analysis excludes one early termination subject|||mg/mL||Standard Deviation|Mean
1229158|NCT00670267|Primary|Daily Dose at Study Termination Across Participants|The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.|Baseline to end of study (105 days)||||participants|||Number
1229159|NCT00670267|Primary|Mean Daily Dose at Study Termination Across Participants|The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.|Baseline to end of study (105 days)||||mg||Standard Deviation|Mean
1229160|NCT00670241|Secondary|Subjects With Rebound During the Study||Week 8-16||||participants|||Number
1229161|NCT00670241|Secondary|Subjects With Relapse During the Study|Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit|Week 8-16||||participants|||Number
1229162|NCT00670241|Secondary|The Percentage Change in PASI From Baseline to Week 8|PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst).|Baseline, Week 4 and 8||||Percent change in PASI score|||Number
1229163|NCT00670241|Secondary|"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity at Week 4"||Week 4||||participants|||Number
1229164|NCT00670241|Primary|"Subjects With Controlled Disease (Clear or Almost Clear Disease) According to Investigator's Global Assessment of Disease Severity at Week 8"||Week 8||||Participants|||Number
1229165|NCT00670228|Secondary|Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)||At Day 60|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.|||mg/L||Standard Deviation|Mean
1229166|NCT00670228|Secondary|Occurrence of the Major Adverse Cardiovascular Events (MACE)|"MACE:~Cardiac death, New onset or worsening congestive heart failure (>24 h post-admission) event evaluating using New York Heart Association (NYHA) Class II or greater Non-fatal Myocardial Infarction, Severe arrhythmia, Stroke/TIA (Transient Ischemic Attack), Cardiogenic shock, Catheterization/revascularization, Unstable angina leading to hospitalisation"|At Day 60|Analysis was performed on the safety population which includes all subjects who received any study treatment. All subjects in this population were analyzed according to the actual treatment they received.|||events|||Number
1229167|NCT00670228|Secondary|Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)|Due to study early termination and the limited number of randomized subjects, descriptive statistics for the Day 3 Ejection Fraction were selected for presentation instead of for Day 60 as initially planned.|At Day 3|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.|||percentage of Ejection Fraction||Standard Deviation|Mean
1229168|NCT00670228|Primary|Infarct Size Absolute Change From Baseline at Day 60|Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.|From baseline at Day 60|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.|||percentage of LV mass change||Standard Deviation|Mean
1229169|NCT00670202|Primary|Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.|We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo.|>= 2 weeks|||||||
1229170|NCT00670111|Secondary|Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.|"Each patient had RAP therapy On from one through six months. This endpoint evaluated Peak VO2 measured at 6 months (RAP On) vs. Peak VO2 measured at 1 month without RAP therapy (RAP Off).All participants were RAP On for months 1 through 6. All participants were 'Rap On' for months 6 to 12."|6 months post implant|"The following were required for a patient's dataset to be included in the analysis:~2 CPX tests had to be performed (1M with RAP Off, 6M with RAP On [RAP was On from 1M to 6M]),~Each CPX test had to result in RER ≥ 1.05,~Trending data from the disk had to have been obtained during each CPX test."|||ml/kg/min||Standard Deviation|Mean
1229171|NCT00670111|Primary|Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.|Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.|1 month post implant|"The following were required for a patient's dataset to be included in the analysis:~2 CPX tests had to be performed at 1M (RAP On & RAP Off),~Each 1M CPX test had to result in RER ≥ 1.05,~Trending data from the disk had to have been obtained during each 1M CPX test."|||ml/kg/min||Standard Deviation|Mean
1229172|NCT00670046|Secondary|Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score|"Study questionnaire, known as Functional Assessment of Cancer Therapy - Prostate (FACT-P), were given to participant to complete during study participation. FACT-P is a validated tool to assess self-perceived functionality, psychosocial well-being, and quality of life; and the scoring of the questionnaire was based on the technique published by FACIT (Functional Assessment of Chronic Illness Therapy). The FACT-P is a 39-item questionnaire, with each item being scored from on a Likert scale of 0-4. The total score ranges from 0-156, with a higher score reflecting a better outcome."|at time of enrollment, mid-study, end of study (up to 1 year)|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent; Average FACT-P scores for both arms at Study enrollment, mid study and at end of study is being reported.|||units on a scale||Standard Deviation|Mean
1229173|NCT00670046|Secondary|Number of Participants Who Achieve a Partial Response|Partial Response was defined as any participant that showed an increase in PSA doubling time|one year|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent|||Participants|||Count of Participants
1229174|NCT00670046|Secondary|Number of Participants Who Achieve a Complete Response|Complete response was defined as PSA Doubling Time increasing to greater than 10 months. Blood was drawn monthly during study period (1 year), serum PSA was measured & PSADT calculated. The > 10 month criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper.|one year|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent|||Participants|||Count of Participants
1229175|NCT00670046|Secondary|Duration of PSA Response as Assessed by PSA Doubling Time (PSADT)|Serum PSA was measured once a month, each month for the one year the subjects were on the protocol. PSA Doubling time is defined as the duration for PSA levels in the blood to increase by 100 percent, and is calculated based on the rate of change in serum PSA values. Prostate-specific antigen doubling time (PSADT) was calculated by natural log of 2 (0.693) divided by the slope of the relationship between the log of PSA and time of PSA measurement for each patient (Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697), therefore it can be much greater than the 12 months that we followed the patients for. PSADT was calculated for pre enrollment, at the mid point of the study & at the end of study.|pre-study, mid-study, end of study (up to 1 year)|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent.|||months||Standard Deviation|Mean
1229176|NCT00670046|Primary|Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time|Number of participants exhibiting an increase in observed or predicted prostate-specific antigen (PSA) doubling time after initiation of the study. Blood was drawn monthly during study period (1 year), serum PSA was measured & PSADT calculated. A doubling time of > 10 month is defined as complete response (3. Secondary Outcome) and this criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper. Any increase in PSADT is defined as partial response (4. Secondary Outcome).|1 year|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent|||Participants|||Count of Participants
1229177|NCT00670007|Secondary|Percentage of Subjects With Treatment Emergent Adverse Events|Percentage of subjects with treatment-emergent adverse events (TEAEs): overall, by severity, by relatedness, by seriousness, and which occurred within 24 hours of Zemaira administration.|From baseline up to 2.5 years|Safety population comprises all subjects who were included in the study and who received at least 1 dose of Zemaira during study CE1226_3001.|||percentage of subjects|||Number
1229178|NCT00670007|Secondary|Time to First Pulmonary Exacerbation||Up to 2 years|ITT population.|||years||95% Confidence Interval|Median
1229179|NCT00670007|Secondary|Annual Rate in Subject Years of Pulmonary Exacerbations|Annual exposure‑adjusted incidence rate of pulmonary exacerbations.|Up to 2 years|ITT population.|||Exacerbations/subject year||95% Confidence Interval|Number
1229180|NCT00670007|Secondary|Number of Subjects With Pulmonary Exacerbations||Up to 2 years|ITT population.|||participants|||Number
1229181|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Percent Predicted FEV1||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||Percent change from baseline||Standard Deviation|Mean
1229182|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity)||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||Percent change from baseline||Standard Deviation|Mean
1229183|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||Percent change from baseline||Standard Deviation|Mean
1229184|NCT00670007|Secondary|Change in Subject-reported Symptoms|Patient-reported symptoms were measured using the St George's Respiratory Questionnaire (SGRQ). SGRQ total, symptoms, activity and impact scores range from 0 to 100, with higher scores indicating more limitations, and change from baseline below zero (0) is favorable, indicating improvement.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||units on a scale (change from baseline)||Standard Deviation|Mean
1229208|NCT00669942|Primary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 29, 36, 43, 57, 71, 85, 99 and 113.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||day||Full Range|Median
1229185|NCT00670007|Secondary|Percent Change in Adjusted Lung Density|Percent change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average percent change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||Percent change from baseline||Standard Deviation|Mean
1229186|NCT00670007|Secondary|Absolute Change in Adjusted Lung Density|Absolute change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average absolute change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||g/L||Standard Error|Least Squares Mean
1229187|NCT00670007|Primary|Rate of Change of Adjusted Lung Density|As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (Total Lung Capacity; ie, full inspiration) and FRC (Functional Residual Capacity; ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in the early start and delayed start subgroups from a linear random regression model with country, inspiration state (only for 'TLC and FRC state'), time (time elapsed since Day 1 [CE1226_4001]), treatment and treatment by time interaction as fixed effects and subject and subject by time interaction as random coefficients.|Up to 2 years|Intention-to-treat (ITT) population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||g/L per year||Standard Error|Least Squares Mean
1229188|NCT00669955|Secondary|Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level|Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)|Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only|Plasma bismuth concentrations were analysed in the OBMT arm only. The goal was to determine whether bismuth plasma concentrations would be of 50 ug/l or above at end of treatment, or at the end of study. The results report the number of patients having reached 50 ug/l in the OBMT arm at either of these timepoints.|||participants|||Number
1229189|NCT00669955|Secondary|Overall Compliance to Study Medications|Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population|At the end of the treatment phase (days 8-14)|Safety population.|||participants||Standard Deviation|Mean
1229190|NCT00669955|Secondary|Metronidazole Resistance|Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml|Measured at baseline|Per protocol population|||participants|||Number
1229191|NCT00669955|Secondary|Clarithromycin Resistance|Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above|Measured at baseline|Per protocol analysis population|||participants|||Number
1229192|NCT00669955|Secondary|H. Pylori Eradication and Presence or Past History of Peptic Ulcers|Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows.|Week 6 and week 10 follow-up visits|Per protocol population.|||Participants|||Number
1229193|NCT00669955|Secondary|Number of Patients Experiencing Treatment Emergent Adverse Events.|"A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation.~All safety analysis based on the safety population."|at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.|Safety population, described as all randomized patients having received at least one dose of study medication|||Participants|||Number
1229194|NCT00669955|Primary|Helicobacter Pylori Eradication Confirmed by Urea Breath Test|H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.|Week 6 and week 10 follow-up visits|No imputation method used, as this is the per protocol population, which excludes patients with missing values, or with protocol violations.|||Participants|||Number
1229195|NCT00669942|Secondary|Disease Activity Score (DAS28) of Parts 2 and 3 Participants|The DAS28 is a composite score based on tender and swollen joint counts, C reactive protein (CRP) concentrations, and the participant's global disease activity based on a visual analogue scale (VAS). The tender joint count (based on 28 joints) was calculated by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. The information on various types of tenderness was then collapsed into a single tender versus non-tender dichotomy, and the number of joints that were classified as tender was recorded. The swollen joint count was calculated in the same manner. For CRP concentrations, blood samples were collected and sent to a central laboratory for assessment. For the VAS assessment, the participant used a 100 mm horizontal VAS to assess the severity of his or her arthritis where 0 = none and 100 = most severe. DAS28 scores range from <2.6 (disease remission) to >5.1 (high disease activity).|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.|||scores on a scale||Standard Error|Mean
1229230|NCT00669864|Secondary|Change in 8-point Plasma Glucose Profile|Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||mg/dL||Standard Error|Mean
1229196|NCT00669942|Secondary|Percentage of Parts 2 and 3 Participants Who Achieved ACR50 and ACR70|Clinical response to treatment was assessed according to ACR50 and ACR70 criteria. A participant was defined as an ACR50 or ACR70 responder if the following 3 conditions were met: 1) improvement of ≥50% or ≥ 70%, respectively, in the number of tender joints, 2) improvement of ≥50% or ≥ 70%, respectively, in the number of swollen joints and 3) improvement of ≥50% or ≥ 70%, respectively, in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.|||Percentage of participants|||Number
1229197|NCT00669942|Primary|Pharmacokinetics PK of AIN457: T1/2 in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||Day||Standard Deviation|Mean
1229198|NCT00669942|Primary|Pharmacokinetics PK of AIN457: CL in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||Liters/day||Standard Deviation|Mean
1229199|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Vz in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||Liter||Standard Deviation|Mean
1229200|NCT00669942|Primary|Pharmacokinetics PK of AIN457: AUClast and AUCinf in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||day*ug/mL||Standard Deviation|Mean
1229201|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Cmax in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||ug/mL||Standard Error|Mean
1229202|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Tmax in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||day||Full Range|Median
1229203|NCT00669942|Primary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||day||Standard Deviation|Mean
1229204|NCT00669942|Primary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||Liters/day||Standard Deviation|Mean
1229205|NCT00669942|Primary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||Liters||Standard Deviation|Mean
1229206|NCT00669942|Primary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||day*ug/mL||Standard Deviation|Mean
1229207|NCT00669942|Primary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||ug/mL||Standard Deviation|Mean
1229231|NCT00669864|Primary|Change in HbA1c (Glycosylated Haemoglobin A1c)|Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||percentage (%) of total haemoglobin||Standard Error|Mean
1229209|NCT00669942|Primary|Percentage of Parts 2 and 3 Participants Who Achieved American College of Rheumatology Response of 20 (ACR20)|Clinical response to treatment was assessed according to ACR20 criteria. A participant was defined as an ACR20 responder if the following 3 conditions were met: 1) ≥20% improvement in the number of tender joints, 2) ≥20% improvement in the number of swollen joint and 3) ≥20% improvement in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant.|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.|||percentage of participants|||Number
1229210|NCT00669916|Secondary|Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|All AIN457A treatment group participants|||day||Standard Deviation|Mean
1229211|NCT00669916|Primary|Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score|The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease. The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline. The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease. This outcome measure shows the percentage of patients who experienced a category change from baseline. Category changes of 1, 2 or 3 indicate improvement.|Baseline, Week 4|All participants|||Percentage of participants|||Number
1229212|NCT00669916|Secondary|Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.|||Liters/day||Standard Deviation|Mean
1229213|NCT00669916|Secondary|Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.|||Liters||Standard Error|Mean
1229214|NCT00669916|Secondary|Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|All AIN457A treatment group participants|||day*ug/mL||Standard Deviation|Mean
1229215|NCT00669916|Secondary|Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.|||ug/mL||Standard Deviation|Mean
1229216|NCT00669916|Secondary|Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457 treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.|||days||Full Range|Median
1229217|NCT00669916|Primary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score|The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement.|Baseline, Week 4|All participants|||Percentage change in PASI mean score|||Number
1229218|NCT00669903|Secondary|CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14|GMRT score defined as the –log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate|Baseline and Day 14||||unit on a scale||Standard Error|Least Squares Mean
1229265|NCT00669331|Secondary|Lung Function - Change in FVC (Forced Vital Capacity)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment|||mL||95% Confidence Interval|Least Squares Mean
1229219|NCT00669903|Secondary|CogState Identification Task (IT) Standardized Change Score at Day 14|IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate|Baseline and Day 14||||unit on a scale||Standard Error|Least Squares Mean
1229220|NCT00669903|Secondary|CogState Detection Task (DT) Standardized Change Score at Day 14|DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14||||units on a scale||Standard Error|Least Squares Mean
1229221|NCT00669903|Secondary|CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14|OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14||||units on a scale||Standard Error|Least Squares Mean
1229222|NCT00669903|Secondary|CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14|GMLT score is defined as the –log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14||||units on a scale||Standard Error|Least Squares Mean
1229223|NCT00669903|Primary|CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14|The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14||||units on a scale||Standard Error|Least Squares Mean
1229224|NCT00669877|Other Pre-specified|Overall Response Rate: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR)|Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10^9/L, a platelet count ≥100 × 10^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to <100 × 10^9/L. Partial remission (PR) was defined as a bone marrow with >5% and <25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR.|After two 21-day courses, response to treatment checked for Complete Remission (CR)|Of fifty-six registered, nine participants entered the study with CR therefore were not evaluable for response.|||percentage of participants|||Number
1229225|NCT00669877|Primary|Complete Remission Rate: Percentage of Participants With Complete Remission (CR)|Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10^9/L, a platelet count ≥100 × 10^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to <100 × 10^9/L. Partial remission (PR) was defined as a bone marrow with >5% and <25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR.|After two 21-day courses, response to treatment checked for Complete Remission (CR)|Of fifty-six registered, nine participants entered the study with CR therefore were not evaluable for response.|||percentage of participants|||Number
1229226|NCT00669864|Secondary|Hypoglycaemic Episodes, Diurnal/Nocturnal|Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).|weeks 0-16|Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||episodes|||Number
1229227|NCT00669864|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||episodes|||Number
1229228|NCT00669864|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||percentage of participants|||Number
1229229|NCT00669864|Secondary|Percentage of Subjects Achieving HbA1c Less Than 7.0%|Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||percentage of participants|||Number
1229266|NCT00669331|Secondary|Lung Function - Change in FEV1 (Forced Expiratory Volume in One Second)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment|||mL||95% Confidence Interval|Least Squares Mean
1229232|NCT00669682|Primary|Number of Positive Twave Studies and Concurrent Positive Optivol Measurement|We wanted to examine whether positive Optivol status corresponded to a higher likelihood of a positive T wave study. The T wave alternans result is determined by a proprietary device that measures T wave and reports the result as negative, positive, or indeterminate. The Optivol measurement is obtained through transthoracic impedance values in the implanted device. We investigated the correlation between Optivol status and T wave alternans status.|upto 3 years||||participants|||Number
1229233|NCT00669669|Secondary|Number of Participants With Chemoprotection|assessed by the ability to increase the Temozolomide dose beyond 472 mg/m^2|Up to 15 years||2027-12-31|12/2027||||
1229234|NCT00669669|Secondary|Gene Transfer Efficiency and in Vivo Selection|Assessed by gene marking in peripheral blood and marrow|Up to 15 years||2027-12-31|12/2027||||
1229235|NCT00669669|Secondary|Time to Progression|From the first day of treatment until unequivocal progression is documented, assessed up to 15 years|Up to 15 years||2027-12-31|12/2027||||
1229236|NCT00669669|Secondary|Number of Participants That Survived|From the first day of treatment until death, assessed up to 15 years|Up to 15 years||2027-12-31|12/2027||||
1229237|NCT00669669|Secondary|Duration of Response|From the onset of temozolomide to the date at which unequivocal disease progression, assessed up to 15 years|Up to 15 years||2027-12-31|12/2027||||
1229238|NCT00669669|Secondary|Response Rate|Proportion of patients with reduction in tumor burden of a predefined amount|Up to 15 years||2027-12-31|12/2027||||
1229239|NCT00669669|Primary|Number of Participants With Retrovirus or Leukemia|Replication competent retrovirus or diagnosis of leukemia|Up to 2 years after infusion||||Participants|||Count of Participants
1229240|NCT00669669|Primary|Number of Participants Dose-limiting Toxicity (DLT)|Defined as any grade 4 nonhematopoietic toxicity that is likely related to the investigational procedures (Part I)|Up to 6 weeks after infusion||||Participants|||Count of Participants
1229241|NCT00669617|Primary|Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose|FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.|Five Minutes Post Dose|Modified Intent-to-Treat (mITT) population: including all randomized patients who received at least one dose of study drug. If any of the values used in the period baseline FEV1 and FEV1 at 5 min post-dose were collected within 6 hours of rescue medication, then the individual FEV1 value was set to missing.|||Liters||Standard Error|Least Squares Mean
1229242|NCT00669578|Primary|Best Overall Response Over the First 6 Cycles of Treatment|"Response evaluation:~Complete Remission (CR):~Neutrophil count between 1 to 10 x 10^9/L without peripheral blasts in blood or bone marrow.~Partial Hematologic Response/Partial Remission (PR):~Increase in neutrophil by 50% + above 10^9/L for neutropenia)~Clinical Improvement (CI):~Increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts."|Every cycle of treatment for 6 cycles. Each cycle is 28 days.|None of the participants from the Phase I cohort were analyzed for this endpoint. All 65 Phase II participants were evaluable for this endpoint and included in the analysis.|||participants|||Number
1229243|NCT00669578|Secondary|Time to Response|The time to response is defined as the time from study registration to the first date at which the patient’s objective status was classified as a response (CR, PR or CI). In patients who do not achieve a response, time to response will be censored at the patient’s last evaluation date. The distribution for each of these event-time variables (duration of response and time to response) will be estimated by Kaplan-Meier curves.|Time from registration to the first date of response within twelve 28-day cycles of treatment.|None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) patients were recruited for the Phase II portion. Only 9 of the 65 patients achieved a response. Thus, the median of time to response and the upper limit of 95% confidence interval are not attainable.||||||
1229244|NCT00669578|Secondary|Duration of Response Time|Duration of response is defined as the date at which the patient’s objective status is first noted to be a CR, PR or CI to the date progression is documented (if one has occurred) or to the date of last follow-up(for those patients who have not progressed).|Time from response to disease progression, intolerance of study drug, or death.|None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) participants were recruited for the Phase II portion. Results presented here are on the 9 Phase II patients who responded to treatment.|||Months||95% Confidence Interval|Median
1229245|NCT00669578|Secondary|Number of Participants With Treatment Related Adverse Events.|Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. The number of participants with grade 3 or higher adverse events at least possibly related to study treatment are reported here.|During treatment and every 6 months until 3 years from registration or progression.|None of the Phase I participants were used for this primary endpoint. All 65 Phase II participants were evaluable for this endpoint.|||participants|||Number
1229246|NCT00669578|Primary|Determine the Maximum Tolerated Dose of CC-4047|Starting at a dose level of 2.5 mg/d on days 1-21 in every 28 day cycle, participants were accrued in cohorts of three to assess dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD). Dose escalation at increments of 0.5 mg/d was done if no subject had a DLT (a grade 4 or higher hematologic toxicity or a grade 3 or higher febrile neutropenia or a grade 3 or higher non-hematologic toxicity) in cycle 1. Subsequent cohorts were treated until the maximum tolerated dose (MTD) was reached (dose level before that which results in a DLT in >1 of 6 subjects). Subsequent participants were treated at the MTD, those without response at the MTD after 3 cycles were lowered to the minimal efficacious dose (MED) of 0.5 mg daily. Here, we are reporting the percentage of participants in Phase I with a DLT at each dose level.|The first 28-day cycle of treatment.|None of the Phase II participants were evaluable for this endpoint. For the Phase I portion of this study, three participants were accrued at a 2.5 mg/day dose level, six at the 3.0 mg/day dose level, and three at the 3.5 mg/day dose level.|||percentage of participants with DLT|||Number
1229909|NCT00665626|Secondary|Bilirubin >2x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229247|NCT00669552|Primary|Number of Subjects With Positive T Wave Studies During a Coronary Intervention|Positive T wave alternans is determined by a proprietary program using ECG recordings during a stress test. The result is reported as positive, negative, or indeterminate.|During the coronary intervention, upto 2 hours|Only collected on subjects that had an intervention|||participants|||Number
1229248|NCT00669539|Primary|Mean Amblyopic Eye Visual Acuity Improvement With Spectacles|Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.|Enrollment to 18 Weeks|Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.|||logMAR units||Standard Deviation|Mean
1229249|NCT00669461|Secondary|Average Number of Spontaneous Bowel Movements (SBM) Per Week|Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)).|up to 6 weeks|Analysis was not performed for this outcome measure secondary to the small sample size ( one patient.||||||
1229250|NCT00669461|Primary|Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks|The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).|up to 6 weeks|Analysis was not performed for this outcome measure secondary to the small sample size ( one patient)||||||
1229251|NCT00669396|Secondary|IUD Expulsion, Removal, or Perforation|patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.|6 months||||participants|||Number
1229252|NCT00669396|Secondary|Infection|diagnosis and treatment for pelvic inflammatory disease|6 months||||participants|||Number
1229253|NCT00669396|Secondary|Pregnancy|positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.|6 months||||participants|||Number
1229254|NCT00669396|Primary|Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception|Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.|6 months||||participants|||Number
1229255|NCT00669331|Other Pre-specified|Cost Effectiveness of Treating Patients With Bronchiectasis With Inhaled Mannitol|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, cost effectiveness was not collected).|52 weeks|Not collected. As the primary objective of this study did not reach statistical significance, cost effectiveness data were not collected.||||||
1229256|NCT00669331|Other Pre-specified|Health Related Quality of Life (HRQL) and Quality Adjusted Life Years (QALYs) by Treatment Group Using Utility Scores From the Health Utilities Index Questionnaire|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, HRQL and QALYs were not collected).|52 weeks|No data were collected for this assessment. As the primary objective of this study did not reach statistical significance, HRQL and QALYs were not derived.||||||
1229257|NCT00669331|Other Pre-specified|Health Status and Utility Scores|In the presence of a significant primary endpoint, these data were intended to be derived from the trial data and external information (Note as the primary objective of this study did not reach statistical significance, differences in health status and utility scores were not assessed)|52 weeks|No data were collected. As the primary objective of this study did not reach statistical significance, health status and utility scores were not derived.||||||
1229258|NCT00669331|Other Pre-specified|Health Related Costs of Treating Patients With Bronchiectasis|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data together with external information (Note as the primary objective of this study did not reach statistical significance, health related costs were not assessed)|52 weeks|No data were collected. Since the primary objective was not significant in this study, further exploration of health economic endpoints was not done.||||||
1229259|NCT00669331|Secondary|• (Exploratory) Number of Hospitalizations Due to Pulmonary Exacerbations|Mean rate of hospitalisations (number/year) summarised and analysed to take account of differing follow-up times.|52 weeks||||hospitalisations/year||95% Confidence Interval|Mean
1229260|NCT00669331|Secondary|Safety Profile - Hematology|hematology assessed as clinically significant abnormal FBC (Full Blood count) at any point post baseline.|52 weeks||||participants|||Number
1229261|NCT00669331|Secondary|Safety Profile - Clinical Chemistry|Clinical chemistry was assessed as clinically significant abnormal liver function test and clinically significant abnormal urea/electrolyte test at any point post baseline.|52 weeks||||participants|||Number
1229262|NCT00669331|Secondary|Safety Profile - Sputum Microbiology|sputum microbiology assessed as the presence of abnormal flora in sputum sample taken at any post baseline visit|52 weeks||||participants|||Number
1229263|NCT00669331|Secondary|Lung Function - Change in FEF25-75 (Forced Expiratory Flow Rate Averaged Over 25th -75th Percentile of FVC)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment|||mL/s||95% Confidence Interval|Least Squares Mean
1229264|NCT00669331|Secondary|Lung Function - Change in FEV1/FVC|FEV1 expressed as a ratio of FVC. Endpoint is expressed as a percentage ie FEV1/FVC*100|52 weeks|Randomised and treated with at least one post-baseline spirometry assessment|||ratio (expressed as a %)||95% Confidence Interval|Least Squares Mean
1229267|NCT00669331|Secondary|Daytime Sleepiness Scores|Epworth Sleepiness Scale (ESS) score was calculated as the sum of scores for each of eight individual questions, such that a total score of zero represents no daytime sleepiness, and a total score of 24 represents the maximum degree of daytime sleepiness. Measured at baseline, 6 weeks, 16 weeks, 28 weeks, 40 weeks, 52 weeks|52 weeks||||units on a scale||Standard Deviation|Mean
1229268|NCT00669331|Secondary|Sputum Volume|24 hour sputum weight, measured at baseline, week 6, week 16, week 28, week 40, week 52|52 weeks||||g||Standard Deviation|Mean
1229269|NCT00669331|Secondary|Duration of Graded Exacerbations|Duration of graded exacerbations is defined as the number of days with graded PE within one treatment year. Mean days estimated via negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, with log of follow-up time as the offset variable|52 weeks|Randomised and treated|||Days with GPE||95% Confidence Interval|Mean
1229270|NCT00669331|Secondary|Time to First Graded Exacerbation|Time to first graded exacerbation is defined as the duration (in months) from the randomisation date to the start of the first reported graded PE during the on-treatment period. Patients without reported graded PE event will be censored at the last participation.|52 weeks|Randomised and treated|||months||95% Confidence Interval|Median
1229271|NCT00669331|Secondary|Antibiotic Use Prescribed for Treated Pulmonary Exacerbations|Rate of antibiotic treated graded pulmonary exacerbations, using the same definition of a graded pulmonary exacerbation as the primary endpoint. A graded pulmonary exacerbation was considered to be anti-biotic treated if use of oral, IV or inhaled antibiotic use was recorded related to the GPE event.|52 weeks|Randomised and treated (referred to as ITT)|||events/year|||Number
1229272|NCT00669331|Secondary|Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score|The SGRQ was collected at baseline, week 6, week 16, week 28, week 40 and week 52. Change in total score was calculated from baseline. Total scores are a weighted sum across all questions. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. Higher scores indicate lower quality of life. Outcome data table gives the raw mean total score at each visit.|52 weeks|Randomised and treated with one or more post-baseline SGRQ data available|||units on a scale||Standard Deviation|Mean
1229273|NCT00669331|Primary|Rate of Graded Pulmonary Exacerbations|A graded pulmonary exacerbation was defined as a worsening in signs and symptoms requiring a change in treatment (Center for Drug Evaluation and Research (CDER), 2007). Grade I was required 3 main signs and symptoms, Grade II 2 main signs and symptoms and Grade III 1 main and one or more minor signs and symptoms. Main signs and symptoms were increased cough, sputum volume or sputum purulence. Minor were upper respiratory tract infection, fever, increased wheezing, increased dyspnea, increase in respiratory rate, increase in cardiac frequency of >20%, and increased malaise, fatigue or lethargy. Rate is defined as the number of all GPE events observed in one treatment year|52 weeks|Randomised and Treated (referred to as the ITT population in this trial)|||GPE events per year|||Number
1229274|NCT00669318|Secondary|Time to Retreatment|Time to subsequent therapy is defined to be the time from the registration to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier|Follow-up status and retreatment information will be collected up to 5 years from registration||||months||95% Confidence Interval|Median
1229275|NCT00669318|Secondary|Progression-free Survival|The progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Follow-up status and retreatment information will be collected up to 5 years from registration||||months||95% Confidence Interval|Median
1229276|NCT00669318|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Follow-up status and retreatment information will be collected up to 5 years from registration||||months||95% Confidence Interval|Median
1229277|NCT00669318|Secondary|Overall Response Rate (Complete and Partial Response)|"A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, and lymphocytes <4000/uL. A bone marrow biopsy with evidence of <30% lymphocytes and no nodules.~Patients who fulfill all criteria for a CR but have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity will be classified as CR with incomplete marrow recovery (CRi).~A Partial Response (PR) requires a 50% reduction in nodes and liver/spleen measurements and at least two of the following: absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, or a >50% reduction in lymphocytes.~Here we report the rate of overall response as the number of patients attaining a CR, PR, or CRi status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution."|Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)||||percentage of patients||95% Confidence Interval|Number
1229278|NCT00669318|Primary|Complete Response Rate|"A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, and lymphocytes <4000/uL. In addition, a bone marrow biopsy with evidence of <30% lymphocytes and no nodules.~Here we report the rate of complete response as the number of patients attaining a CR status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution."|Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)||||percentage of participants||95% Confidence Interval|Number
1229279|NCT00669279|Secondary|Peripheral Blood Pressure||Measured at baseline, 2 weeks, and 4 weeks.|||||||
1229280|NCT00669279|Primary|Central Aortic Blood Pressure||Measured at baseline and 4 weeks.||||mmHg||Standard Error|Mean
1229293|NCT00669214|Secondary|Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks|"Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint)."|Week 12|ITT population. N's reflect patients who received at least one dose of study drug or placebo in the double-blind treatment period.|||Pecentage of BSA||Standard Deviation|Mean
1229281|NCT00669240|Secondary|Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium|Self-administered rating of intensity of nicotine withdrawal symptoms over past 24 hours; consists of 9 questions (urge to smoke, depressed mood, irritability, anxiety, difficulty concentrating, restlessness, increased appetite, difficulty going to sleep, difficulty staying asleep), each rated 0-4 (0=not at all, 1=slight, 2=moderate, 3=quite a bit, 4=extreme). Subscales: Negative affect domain (average of items 2-5); Insomnia domain (average of items 8 and 9); Urge to smoke (item 1); Restlessness (item 6); Increased appetite (item 7). Range 0-4 (higher score=greater intensity of symptoms)|Week 7 and Week 13 or 14 (Week 13/14)|All subjects population in Belgium; n=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
1229282|NCT00669240|Secondary|Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program|"Number of participants who answered 'yes' to the question Did you register with LifeREWARDS? (LifeREWARDS not available in Greece.)"|Week 12|All-subjects population; n=number of participants with analyzable data at observation (responded to the question at the last study visit).|||participants|||Number
1229283|NCT00669240|Secondary|Number of Participants Who Received Varenicline, by Duration of Treatment in Days||Baseline through Week 12 or Week 24|All-subjects population; Week 24 if a maintenance period was prescribed.|||participants|||Number
1229284|NCT00669240|Secondary|Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12|A maintenance period was an additional period of varenicline treatment that could be prescribed at Week 12 by the attending primary care physician in routine clinical practice|Week 12|All-subjects population|||participants|||Number
1229285|NCT00669240|Secondary|Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11|"Responders are participants who answered no to the following 2 questions: 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days? Assessment conducted at specified time points only when usual for the local clinical practice."|Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11|All-subjects population; n=number of participants in the All-subjects population with analyzable data (responders and non-responders) who were assessed for smoking cessation at the time point (per local clinical practice) .|||participants|||Number
1229286|NCT00669240|Secondary|Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11|Assessment of smoking cessation (ie, not a single puff) in previous 7 days, at time points of routine review of patients per local clinical practice.|Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11|All-subjects population|||participants|||Number
1229287|NCT00669240|Secondary|Number of Treatment Responders in Belgium at Week 12 and at Week 24|"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?"|Week 12 and Week 24|All-subjects population in Belgium|||participants|||Number
1229288|NCT00669240|Secondary|Number of Treatment Responders at Week 12|"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?"|Week 12|All-subjects population|||participants|||Number
1229289|NCT00669240|Secondary|Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks|"Number of participants in Belgium who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)"|Week 12 and Week 24|All-subjects population in Belgium|||participants|||Number
1229290|NCT00669240|Secondary|Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks|"Number of participants who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)"|Week 12|All-subjects population|||participants|||Number
1229291|NCT00669240|Primary|Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)|Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.|Baseline through Week 12 or Week 24|Safety population, which is identical to the all-subjects population: all enrolled subjects who received at least 1 dose (including partial doses) of varenicline; Week 24 if a maintenance period was prescribed.|||participants|||Number
1229292|NCT00669214|Secondary|Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks|"Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint)."|Week 24|ITT population. N's reflect patients who received at least one dose of study drug in the open-label period.|||Percentage of BSA||Standard Deviation|Mean
1229354|NCT00668863|Secondary|Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.|Plasma concentrations were assessed at predose, 2, 4, 6, 8, and 24 hours postdose and Cmax and Ctrough of sunitinib, its metabolite SU012662, and the total (sunitinib + SU0122662) were determined.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng/mL||Standard Deviation|Mean
1229294|NCT00669214|Secondary|Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks|Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient’s scalp itch on a scale of 0 to 10, where 0 was “no itching,” 5 was “moderate itching,” and 10 was “severe itching.”|Week 24|ITT population. If VAS at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 168 was missing for a patient who completed the Day 161 dose, the last available VAS was used for analysis.|||Points on VAS||Standard Deviation|Mean
1229295|NCT00669214|Secondary|Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks|Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient’s scalp itch on a scale of 0 to 10, where 0 was “no itching,” 5 was “moderate itching,” and 10 was “severe itching.”|Week 12|ITT population. If VAS at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 84 was missing for a patient who completed treatment, the last available VAS from the treatment period was used for analysis.|||Points on VAS||Standard Deviation|Mean
1229296|NCT00669214|Secondary|Mean Change in Scalpdex Score at 24 Weeks|Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.|Week 24|ITT population. If Scalpdex at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 168 was missing for a patient who completed the Day 161 dose, the last available Scalpdex was used for analysis.|||Points on Scalpdex||Standard Deviation|Mean
1229297|NCT00669214|Secondary|Mean Change in Scalpdex Score at 12 Weeks|Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.|The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84|ITT population. If Scalpdex at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 84 was missing for a patient who completed treatment, the last available Scalpdex from the treatment period was used for analysis.|||Points on Scalpdex||Standard Deviation|Mean
1229298|NCT00669214|Secondary|Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks|Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks.|Week 24|ITT population. If PGA rating at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 168 was missing for a patient who completed the Day 161 dose, the last available PGA rating was used for analysis.|||Proportion of patients||95% Confidence Interval|Number
1229299|NCT00669214|Secondary|Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks|"Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84)~Physician's Global Assessment (PGA) scale:~0: Clear. No signs of plaque psoriasis.~Almost clear. Just perceptible erythema and just perceptible scaling.~Mild disease. Light pink erythema with minimal scaling.~Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening.~Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening."|Week 12|ITT population. If PGA rating at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 84 was missing for a patient who completed treatment, the last available PGA rating from the treatment period was used for analysis.|||Proportion of patients|||Number
1229300|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks|Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 24|ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.|||Proportion of patients||95% Confidence Interval|Number
1229301|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks|Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 12|ITT population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.|||Proportion of patients|||Number
1229319|NCT00669110|Primary|Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.|Baseline (Extension study) up to Extension study Week 29 Follow up visit|Safety population (Baseline=Extension study) includes all treatment assigned participants with at least 1 dose of study treatment during Extension study NCT00669110.|||participants|||Number
1229302|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks|Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 24|ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.|||Proportion of patients||95% Confidence Interval|Number
1229303|NCT00669214|Primary|Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks|Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 12|Intent-to-treat (ITT) population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.|||Proportion of patients|||Number
1229304|NCT00669110|Other Pre-specified|Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)|Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of ≥4 millimoles per liter (mmol/L); hematocrit <0.32 or >0.50 (females) or <0.37 or >0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease >0.21 mmol/L and test value ≥1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) ≥2.258 mmol/L or increase ≥1.13 mmol/L and test value ≥3.39 mmol/L; urine specific gravity <1.001 or >1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable laboratory data. Participants may be represented in >1 category.|||participants|||Number
1229305|NCT00669110|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)|PCI criteria for females: heart rate (bpm) ranges from <68 and >126 at age 6 to <63 and >121 at age 11; heart rate from <63 and >121 at age 12 to <54 and >110 at age 17; heart rate <50 and >104 at age 18. Criteria for males: heart rate ranges from < 68 and >126 at age 6 to <63 and >121 at age 11; heart rate <58 and >116 at age 12 up <50 and >104 at age 17; heart rate <45 and >99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data.|||participants|||Number
1229306|NCT00669110|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)|ECG results meeting the criteria for PCI categorized as PR interval ≥200 milliseconds (msec); QT interval ≥480msec; QRS interval ≥120 msec; corrected QT (QTc) ≥500 msec ); >450 msec for males and >470 msec for females or increase of ≥60 msec or ≥30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data. Participants may be represented in >1 category.|||participants|||Number
1229307|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate|PCI criteria for females: supine pulse rate (beats per minute [bpm]) ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <63 or >121 at age 12 to <54 or >110 at age 17; pulse from <50 or >104 at age 18. Criteria for males: pulse ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <58 or >116 at age 12 to <50 or >104 at age 17; pulse from <45 or >99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse ≥20 bpm for last supine to first standing pulse [supine to standing]).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).|||participants|||Number
1229308|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight|Vitals signs meeting the PCI criteria for weight categorized according to an increase of ≥7 percent or a decrease of ≥3.5 percent in body weight.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).|||participants|||Number
1229309|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)|PCI criteria for females: systolic BP [SBP] ranges from >110 and diastolic BP [DBP] >73 (>110/73) at age 6 up to BP >124/81 at age 11; BP from >121/79 at age 12 up to BP >132/86 at age 17. Criteria for males: BP ranges from >112/73 at age 6 up to BP >123/82 at age 10; BP from >119/79 at age 11 up to BP >140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP ≥20 millimeters of mercury [mmHg] or in DBP ≥15 mmHg for the last supine to first standing BP [supine to standing]).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).|||participants|||Number
1229320|NCT00669071|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events|Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events|Baseline to week 10|Safety|||participants|||Number
1229355|NCT00668863|Secondary|Duration of Response (DR)|DR is defined as the time from the first objective documentation of complete or partial response that is subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurs first. The definition of censorship is the same as PFS.|Up to 11 cycles (1 cycle = 6 weeks)|Analysis set was consisted of participants with a confirmed objective tumor response (CR or PR) among Full Analysis Set.|||weeks||95% Confidence Interval|Median
1229310|NCT00669110|Other Pre-specified|Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males|Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.|Baseline (Extension study), Week 26 (Extension study)|Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.|||participants|||Number
1229311|NCT00669110|Other Pre-specified|Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females|Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.|Baseline (Extension study), Week 26 (Extension study)|Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.|||participants|||Number
1229312|NCT00669110|Other Pre-specified|Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Participant with response is defined as having a score of 1 (very much improved) or 2 (much improved).|Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.|||percentage of participants|||Number
1229313|NCT00669110|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. No participants had a CGI-I score of 6 or 7 (much worse, very much worse), therefore only scores 1 through 5 (very much improved to minimally worse) are reported. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.|||percentage of participants|||Number
1229314|NCT00669110|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. No participants had a CGI-S score of 5, 6 or 7 (markedly, severely, or extremely ill), therefore only scores 1 through 4 (normal to moderately ill) are reported.|||percentage of participants|||Number
1229315|NCT00669110|Other Pre-specified|Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score|HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.|Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF.|||scores on a scale||Standard Deviation|Mean
1229316|NCT00669110|Other Pre-specified|Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale – Revised (CDRS-R)|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission defined as a CDRS-R total score ≤28 (coded value of 1).|Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF.|||percentage of participants|||Number
1229317|NCT00669110|Other Pre-specified|Change From Baseline (Bsl) in Children's Depression Rating Scale – Revised (CDRS-R) Total Score at Final On-therapy Visit|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.|Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination)|Intent to Treat population (ITT): all treatment assigned participants with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after first dose in Extension study NCT00669110. Last observation carried forward (LOCF).|||scores on a scale||Standard Deviation|Mean
1229318|NCT00669110|Primary|Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)|Safety population (Baseline=Core study) includes all treatment assigned participants with at least 1 dose of study treatment during Core study NCT00619619 and Extension study NCT00669110.|||participants|||Number
1229321|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 10 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1229322|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 6 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1229323|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 10 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1229324|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 6 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1229325|NCT00669071|Secondary|Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10|Degree of pigmentation (melanin) using a Mexameter to record units on a scale at Weeks 6 and 10; units on a scale is a number that represents the presence or absence of melanin in the skin on a scale from 0 - 999 units with 0 units representing no melanin and 999 units representing the maximum amount of melanin.|Baseline to Week 6 and Baseline to Week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||units on a scale||Standard Deviation|Mean
1229326|NCT00669071|Secondary|Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure|Number of participants who were a success or failure with regards to melasma severity at Week 6 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1229327|NCT00669071|Primary|Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma|Number of participants who were a success or failure with regards to melasma severity at Week 10 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1229328|NCT00669032|Secondary|Mean Daily Dose of Paracetamol Consumption|Mean daily dose of paracetamol consumption throughout the study, an average of 40 months|Throughout the study, an average of 40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||mg/day||Standard Deviation|Mean
1229329|NCT00669032|Secondary|Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis|Consumption of rescue medication (paracetamol/NSAID) for osteoarthritis throughout the study, an average of 40 months|Throughout the study, an average of 40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
1229330|NCT00669032|Secondary|Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up|"Percentage of patients with an increase in the score of patient's global assessment by at least 20% and at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a better outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
1229331|NCT00669032|Secondary|Function Improvement 20% (10mm) at the End of Follow-up|"Percentage of patients with a decrease in physical function score of at least 20% or at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
1229332|NCT00669032|Secondary|Overall Pain Reduction 20% (10mm) at the End of Follow-up|"Percentage of patients with a decrease in pain score of at least 20% or at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
1229333|NCT00669032|Secondary|Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up|"Percentage of patients with a decrease in pain or physical function score of at least 50% and at least 20mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
1229394|NCT00667992|Secondary|Peak Exploratory Flow (PEF) Morning|Peak Exploratory Flow (PEF) recorded daily in the morning|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Liters/minutes||95% Confidence Interval|Least Squares Mean
1229334|NCT00669032|Secondary|Responders OARSI 2004 at 34 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 34 months follow-up visit (6 months after fourth cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|34 months (6 months after fourth cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
1229335|NCT00669032|Secondary|Responders OARSI 2004 at 27 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 27 months follow-up visit (12 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|27 months (12 months after third cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
1229336|NCT00669032|Secondary|Responders OARSI 2004 at 21 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 21 months follow-up visit (6 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|21 months (6 months after third cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
1229337|NCT00669032|Secondary|Responders OARSI 2004 at 14 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 14 months follow-up visit (6 months after second cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|14 months (6 months after second cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
1229338|NCT00669032|Secondary|Responders OARSI 2004 at 7 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 7 months follow-up visit (6 months after first cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|7 months (6 months after first cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
1229339|NCT00669032|Primary|Responders OARSI 2004 at the End of Follow-up|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
1229340|NCT00669019|Secondary|Progression-free Survival|Progression will be evaluated in this study using the RECIST criteria (the appearance of new lesions and/or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). Progression-free survival time was calculated as the time from treatment start to date of progression or death, whichever comes first.|Up to 2 years||||weeks||95% Confidence Interval|Median
1229395|NCT00667992|Secondary|Rescue Medication Total|The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Number of inhalations/24 hours||95% Confidence Interval|Least Squares Mean
1229341|NCT00669019|Primary|Objective Response Rate|"Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum LD; Objective response = CR + PR.~CT scans will be performed at baseline and every 4-8 weeks while on study."|Up to 25 weeks||||percentage of participants||95% Confidence Interval|Number
1229342|NCT00668902|Primary|DOBmax (Maximum Value of DOB)|"The stable isotope [13C]pantoprazole is O-demethylated by cytochrome P450 CYP2C19 and that the 13CO2 produced and exhaled in breath as a result can serve as a safe, rapid, and noninvasive phenotyping marker of CYP2C19 activity in vivo.~Exhaled 13CO2 and 12CO2 were measured by IR spectroscopy before (baseline) and 2.5 to 120 min after dosing. Ratios of 13CO2/12CO2 after [13C]pantoprazole relative to 13CO2/12CO2 at baseline were expressed as change over baseline (DOB)."|baseline and 2.5, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, and 120 min after dosing||||ratio||Standard Deviation|Mean
1229343|NCT00668863|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE).|Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 11 cycles (1 cycle = 6 weeks)|Safety analysis set was defined as the same population as the Full Analysis Set.|||Participants|||Number
1229344|NCT00668863|Secondary|Plasma Concentration at Steady State (Css) of 5-FU|Concentration at 22 hour post start of 5-FU infusion were to be used as Css if 5-FU concentrations suggested steady state at 22 hours time point.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng/mL||Standard Deviation|Mean
1229345|NCT00668863|Secondary|Volume of Distribution at Steady State (Vss) of Irinotecan|Vss was calculated using following equation: CL x mean residence time (MRT), where MRT = the area under the first moment curve from zero time to infinity (AUMC 0-∞)/AUC 0-∞− (infusion time/2), AUMC 0-∞ = the area under the first moment curve from zero time to time t (AUMC t)+ ((t x Ct*)/ kel) + (Ct* / kel^2), AUMC t is calculated using the linear trapezoidal method.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||L||Standard Deviation|Mean
1229346|NCT00668863|Secondary|Clearance of Irinotecan|CL is calculated as dose divided by AUC 0-∞|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||L/hour||Standard Deviation|Mean
1229347|NCT00668863|Secondary|Terminal Phase Elimination Half-life (t1/2) of Irinotecan|Terminal phase half-life of irinotecan was calculated as ln 2/ kel.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||hours||Standard Deviation|Mean
1229348|NCT00668863|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan|"AUC last of irinotecan and its metabolite SN-38 were calculated using the Linear/Log trapezoidal method.~AUC∞ of irinotecan was calculated using following equation; AUC last+(C*t/kel), where Ct* is the estimated concentration at the time of the last quantifiable concentration, kel is terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile."|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng.h/mL||Standard Deviation|Mean
1229349|NCT00668863|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan||Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||hours||Full Range|Mean
1229350|NCT00668863|Secondary|Maximum Observed Plasma Concentration (Cmax) of Irinotecan|Plasma samples were assessed at prior to initiation of irinotecan (and l-leucovorin) infusion, 1, 2 (predose for 5-FU bolus), 4, 8, and 24 hours after initiation of irinotecan infusion, and Cmax of irinotecan and its metabolite SN-38 were determined.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng/mL||Standard Deviation|Mean
1229351|NCT00668863|Secondary|Apparent Oral Clearance (CL/F) of Sunitinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||L/hour||Standard Deviation|Mean
1229352|NCT00668863|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib|AUC 0-24 was determined using the Linear/Log trapezoidal method.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng.h/mL||Standard Deviation|Mean
1229353|NCT00668863|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib||Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||hours||Full Range|Mean
1229396|NCT00667992|Secondary|Rescue Medication Evening|The average of means for inhalations of rescue medication in the evening is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Number of inhalations||95% Confidence Interval|Least Squares Mean
1229356|NCT00668863|Secondary|Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)|ORR is defined as the percentage of participants with best overall response of either a confirmed complete (CR) or partial response (PR) relative to the number of participants in FAS. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.|Up to 11 cycles (1 cycle = 6 weeks)|Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Median
1229357|NCT00668863|Secondary|Overall Survival (OS)|OS is defined as the time from the date of enrollment to the date of death due to any cause. OS data was censored on the day following the date of the last contact at which the patient is known to be alive.|Up to 11 cycles (1 cycle = 6 weeks)|Median OS was not calculable due to the large number of censored events (63 out of 71 were censored).|||weeks||95% Confidence Interval|Median
1229358|NCT00668863|Primary|Progression-Free Survival (PFS)|"PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first.~PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis."|Up to 11 cycles (1 cycle = 6 weeks)|Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication.|||weeks||95% Confidence Interval|Median
1229359|NCT00668811|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment to the time to death from any cause or final data collection, whatever happens first.|12 months after last patient completes treatment||||days||Inter-Quartile Range|Median
1229360|NCT00668811|Primary|Progression Free Survival|Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).|12 months after last patient completes treatment||||days||Inter-Quartile Range|Median
1229361|NCT00668785|Secondary|Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.|March 2010|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.||||||
1229362|NCT00668785|Secondary|Mean Change From Pre-PRP Optical Coherence Tomography (OCT) in Central Foveal Thickness and Macular Volume as Assessed by OCT at 1, 2 and 3 Months.|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.|March 2010|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.||||||
1229363|NCT00668785|Primary|Mean Change From Pre-PRP Best Corrected Visual Acuity (BCVA) at 3 Months as Expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) Score (Number of Letters Correctly Read.)|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.|March 2010|Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.||||||
1229364|NCT00668746|Secondary|Micocycline-Resistance From Saliva Sample|Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects|Baseline, Day 30 and Day 180|ITT|||Percentage of Subjects|||Number
1229365|NCT00668746|Secondary|Micocycline-Resistance From Plaque Samples|Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples|Baseline, Day 30 and Day 180|ITT|||Percentage of Subjects|||Number
1229366|NCT00668746|Primary|Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture|Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.|from Baseline to Day 30 and Day 180|intention to treat (ITT)|||Percentage Change||Standard Deviation|Mean
1229367|NCT00668733|Primary|Number of Participants With Recurrence of AK Lesions|The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.|Up to one year|Efficacy analyses were conducted on the evaluable subject population defined as all subjects who were eligible and enrolled in the follow-up study. All results were summarized overall and by original Phase 3 randomized treatment regimen and dose group. Actinic keratosis recurrence was categorized by presence or absence only.|||participants|||Number
1229368|NCT00668564|Secondary|Overall Survival|Number of patients alive at timepoints.|Day 100, 1 Year, 3 Years|Year 3 survival endpoint was not done due to study being terminated prematurely.|||Participants|||Number
1229369|NCT00668564|Primary|Number of Patients Achieving Engraftment|Rate of successful engraftment - patients who achieved and sustained donor engraftment; donor chimerism by day 100 of at least 90% after undergoing hematopoietic stem cell transplantation.|Day 100||||Participants|||Number
1229397|NCT00667992|Secondary|Rescue Medication Morning|The average of means for inhalations of rescue medication in the morning is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Number of inhalations||95% Confidence Interval|Least Squares Mean
1229570|NCT00667251|Secondary|CNS Metastases at the Time of Progression (ITT)||Incidence rate of CNS metastases at first progression assessed up to 39 months|178 Lapatinib patients with metastases assessed for CNS metastases; 157 Trastuzumab patients with metastases assessed for CNS metastases.|||CNS metastases|||Number
1229370|NCT00668525|Secondary|Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8|The HAMD is a clinician-rated 24-item scale was used to rate the patient’s depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).|Change from baseline in HAM-D at week 8|The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline HAMD total score as a covariate.|||Units on a scale||Standard Error|Mean
1229371|NCT00668525|Primary|Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.|The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).|Change from baseline in MADRS total score at week 8|The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline MADRS total score as a covariate.|||Units on a scale||Standard Error|Mean
1229372|NCT00668434|Secondary|Pain Numerical Rating Scale|Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.|Baseline, Week 52 follow-up||||units on a scale||Standard Error|Mean
1229373|NCT00668434|Secondary|Oswestry Disability Index, v2|The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.|Baseline, Week 52 follow-up||||units on a scale||Standard Error|Mean
1229374|NCT00668434|Secondary|Pain Numerical Rating Scale|Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.|Baseline, Week 3 follow-up||||units on a scale||Standard Error|Mean
1229375|NCT00668434|Primary|Oswestry Disability Index, v2|The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.|Baseline, Week 3 follow-up||||units on a scale||Standard Error|Mean
1229376|NCT00668395|Primary|Effect of CYP2B6 Genotype on Efavirenz Clearance|Efavirenz clearance is a measure of rate of elimination of the drug from the body. We used this measure to evaluate differences in rate of elimination of efavirenz at a single dose and after multiple dosing within three CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and CYP2B6*6/*6). Efavirenz clearance was measured in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6) and slow metabolizer (CYP2B6*6/*6) at a single 600 mg oral dose of efavirenz and then after multiple dosing (autoinduction), i.e., the administration of efavirenz (600 mg/day) for 17 days. Single and multiple dose efavirenz clearance was measured and compared to determine the extent of autoinduction within this genotype group.|Efavirenz clearance at single dose and multiple dose stratified by CYP2B6 genotypes||||ml/h/kg||Standard Deviation|Mean
1229377|NCT00668382|Primary|Number of Subjects With Greater Than Grade 3 or 4 Toxicity|Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection|1 month|Dose escalating Phase 1 scheme: three participants for each dose cohort. The second patient in the last (10 mg) dose cohort developed and adverse event (infection at injection site) and so three more participants were entered and analyzed at that dose|||participants|||Number
1229378|NCT00668317|Secondary|Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire||8 weeks|||||||
1229379|NCT00668317|Primary|Change in Methacholine Sensitivity|"Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20).~To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine"|baseline and 8 weeks|All subjects recruited with efficacy data recorded after week T0 will be included in the ITT population for analysis. Assuming a within subject standard deviation(for change in PC20) of no more than 2.71 units, 30 subjects are sufficient to provide 80% power to detect a treatment difference of 1.8 units using a 5% two sided significance test|||mg/ml||Standard Deviation|Mean
1229380|NCT00668265|Secondary|Beck Depression Inventory at 16 Weeks|To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.|16 weeks|Data were not analyzed. PI left institution, and did not respond to attempts top contact him.||||||
1229381|NCT00668265|Primary|Hamilton Anxiety Scale at 16 Weeks|Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety|16 weeks|Data was not analyzed: PI left the institution and the study was terminated||||||
1229382|NCT00668200|Secondary|Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)|The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.|End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)|This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.|||percentage of patients|||Number
1229398|NCT00667992|Secondary|Asthma Symptom Score Total|Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Units on a scale||95% Confidence Interval|Least Squares Mean
1229383|NCT00668200|Secondary|Change From Baseline in Serum Calcium (mmol/L) – Safety Population|Change from baseline = endpoint – baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used.|Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)|This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.|||mmol/L||Standard Deviation|Mean
1229384|NCT00668200|Primary|Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.|To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium <2.07 mmol/L at 9-11 days after the study drug infusion.|at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)|Safety population which includes 81 patients was used. 75 of the 81 patients in the safety population met the criteria. 6 patients did not meet criteria and were excluded from the analysis: 1 patient had a low serum calcium at baseline, and the other 5 patients were missing serum calcium values either at baseline or post-baseline.|||percentage of patients|||Number
1229385|NCT00668148|Secondary|Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)||30-day safety follow-up|Zero participants analyzed. Analysis was not performed due to lack of available assay.||||||
1229386|NCT00668148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths|TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs, serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.|Baseline through study completion (up to 112.9 weeks)|Enrolled participants who received any quantity of IMC-A12.|||Participants|||Count of Participants
1229387|NCT00668148|Secondary|Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)]|CBR was reported by disease condition. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria. Percentage of participants with best overall response is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100.|Baseline through study completion (up to 105.4 weeks)|Enrolled participants who received any quantity of IMC-A12.|||percentage of participants||95% Confidence Interval|Number
1229388|NCT00668148|Secondary|Overall Survival (OS)|OS was reported by disease condition and defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.|Baseline to date of death from any cause (up to 112.9 weeks)|Enrolled participants who received any quantity of IMC-A12. Five (5) participants in Ewing's sarcoma/PNET, 4 participants in rhabdomyosarcoma, 12 participants in leiomyosarcoma, 11 participants in adipocytic sarcoma, and 5 participants in synovial sarcoma groups were censored for analysis.|||weeks||95% Confidence Interval|Median
1229389|NCT00668148|Secondary|Duration of Response||Date of first response to the date of progression or death due to any cause (up to 105.4 weeks)|Zero participants analyzed. Duration to Response for CR and PR data was not collected for analysis per study report.||||||
1229390|NCT00668148|Secondary|Time to Response||Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks)|Zero participants analyzed. Time to Response for CR and PR data was not collected for analysis per study report.||||||
1229391|NCT00668148|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was reported by disease condition and defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100.|Baseline to measured PD (up to 105.4 weeks)|Enrolled participants who received any quantity of IMC-A12.|||percentage of participants||95% Confidence Interval|Number
1229392|NCT00668148|Secondary|Progression-Free Survival (PFS)|PFS was reported by disease condition and defined as the interval from the date of first dose until disease progression or death whichever occurred earlier. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience disease progression or death.|Baseline to measured PD (up to 105.4 weeks)|Enrolled participants who received any quantity of IMC-A12. Three (3) participants in Ewing's sarcoma/PNET, 1 participant in rhabdomyosarcoma, 4 participants in leiomyosarcoma, 6 participants in adipocytic sarcoma, and 3 participants in synovial sarcoma groups were censored for analysis.|||weeks||95% Confidence Interval|Median
1229393|NCT00668148|Primary|Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks|PFS at 12 weeks was reported by disease condition and defined as the percentage of participants who have neither experienced disease progression nor died at 12 weeks after the date of first dose. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 12 weeks divided by the total number of participants treated then multiplied by 100.|Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks|Enrolled participants who received any quantity of IMC-A12.|||percentage of participants||95% Confidence Interval|Number
1229399|NCT00667992|Secondary|Asthma Symptom Score Evening|Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Units on a scale||95% Confidence Interval|Least Squares Mean
1229400|NCT00667992|Secondary|Asthma Symptom Score Morning|Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Units on a scale||95% Confidence Interval|Least Squares Mean
1229401|NCT00667992|Secondary|eNO (Exhaled Nitrogen Oxide)|eNO ratio of baseline|baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Ratio||95% Confidence Interval|Geometric Mean
1229402|NCT00667992|Secondary|FEF 25-75 (Forced Expiratory Flow 25-75)|FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline|Baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Liters/seconds||95% Confidence Interval|Least Squares Mean
1229403|NCT00667992|Secondary|FEV1 (Forced Expiratory Volume in 1 Second)|FEV1 change from baseline|Baseline to week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Liters||95% Confidence Interval|Least Squares Mean
1229404|NCT00667992|Secondary|Peak Exploratory Flow (PEF)|Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate.|Baseline to week 2 recorded daily|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Liters/minutes||95% Confidence Interval|Least Squares Mean
1229405|NCT00667992|Primary|PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)|"Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%.~The ratio of Methacholine concentration measured at 2 weeks to that at Baseline."|Baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Ratio||95% Confidence Interval|Geometric Mean
1229406|NCT00667875|Secondary|Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance|Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime|16 weeks treatment trial||||Percent of riboflavin positive samples||Standard Deviation|Mean
1229407|NCT00667875|Secondary|Pill Counts During Treatment|Compliance with medication as determined by pill counts|16-week||||Percent of pills taken||Standard Deviation|Mean
1229408|NCT00667875|Primary|Percent Heavy Drinking Days|percent of total 112 day trial in which heavy drinking occurred (>=4 for females, >=5 male)|16 weeks||||percent of days||Standard Deviation|Mean
1229409|NCT00667875|Primary|Drinks Per Drinking Day|Standard drinks per drinking day|16-week treatment period||||drinks per drinking day||Standard Deviation|Mean
1229410|NCT00667849|Other Pre-specified|Treatment Compliance|The percent of subjects who used the device greater than or equal to 18 minutes per day over 80% of the days in their treatment period.|Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit)|FAS with compliance data (subjects who returned the device)|||percentage of compliant participants|||Number
1229411|NCT00667849|Primary|Time (Days) to Radiographic Healing of Tibial Fractures|Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier|over 365 days|Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.|||days||Inter-Quartile Range|Median
1229412|NCT00667849|Primary|Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)|Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best|Over 365 days|Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.|||units on a scale||95% Confidence Interval|Least Squares Mean
1229413|NCT00667810|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78|The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units on a scale||Standard Error|Least Squares Mean
1229474|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-6|Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline|28 weeks|Per-protocol participants with undetectable antibodies to HPV-6 at baseline|||participants|||Number
1229414|NCT00667810|Secondary|Change From Baseline in Dependence Scale Total Score at Week 78|The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units on a scale||Standard Error|Least Squares Mean
1229415|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.|78 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants|||Number
1229416|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants||95% Confidence Interval|Number
1229417|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants|||Number
1229418|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)|Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Number of participants||95% Confidence Interval|Number
1229419|NCT00667810|Secondary|Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
1229420|NCT00667810|Secondary|Time to Median Placebo Deterioration on DAD Total Score|The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
1229421|NCT00667810|Secondary|Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)|The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.|78 weeks||||Days||95% Confidence Interval|Median
1229422|NCT00667810|Secondary|Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)|The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
1229423|NCT00667810|Secondary|Divergence of Effect on the DAD Total Scores From Week 39 to Week 78|The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.|39 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units/Years||Standard Error|Mean
1229424|NCT00667810|Secondary|Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78|The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.|39 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units/Year||Standard Error|Mean
1229425|NCT00667810|Secondary|The Change From Baseline in Brain Volume at Week 71|Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.|71 Weeks|The vMRI population Included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.|||mL/year||Standard Error|Least Squares Mean
1229426|NCT00667810|Secondary|The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.|Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.|71 Weeks|CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).|||pg/mL||Standard Error|Least Squares Mean
1229427|NCT00667810|Secondary|The Change From Baseline in Brain Amyloid Burden at Week 71.|Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer’s pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.|71 Weeks|PiB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one post baseline PiB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI≥1.35 at baseline.|||SUVr||Standard Error|Least Squares Mean
1229428|NCT00667810|Primary|The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.|78 weeks|The Modified Intent-to-Treat (mITT) population included as all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units on a scale||Standard Error|Least Squares Mean
1229429|NCT00667810|Primary|The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|78 weeks|The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.|||Units on a scale||Standard Error|Least Squares Mean
1229430|NCT00667745|Secondary|Suicidality as Measured by the Modified Scale for Suicidal Ideation (MSSI)|The Modified Scale for Suicide Ideation (MSSI) assesses the presence of absence of suicide ideation and the degree of severity of suicidal ideas. The time frame is from the point of interview and the previous 48 hours. It uses 13 items from the Scale for Suicidal Ideation (SSI) and 5 new items. The modifications increased both reliability and validity. The scale was also changed to range from 0 to 3, yielding a total score ranging from 0 to 54. A total score is attained by summing all of the items. A score between 0-8 indicates low suicidal ideation; 9-20 indiciates mild-moderate suicidal ideation; 21+ indicates severe suicidal ideation.|Measured over 6 months||||units of scale||Standard Deviation|Mean
1229431|NCT00667745|Secondary|Mania Symptoms as Measured by the Young Mania Rating Scale (YMRS)|The scale has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. There are four items that are graded on a 0 to 8 scale with 0 indicating that symptoms are absent and 8 indicating that symptoms are severe (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale, with 0 indicating that symptoms are absent and 4 indicating that symptoms are severe (Elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, and insight). Total scores can vary from 0-60, with 0 indicating that symptoms are completely absent and 60 indicating that the patient is severely manic.|Measured over 6 months||||units on a scale||Standard Deviation|Mean
1229432|NCT00667745|Secondary|Depression Symptoms as Measured Self Report Montgomery Asberg Depression Rating Scale (MADRS)|"The MADRS is a 10-item measure and has a fixed scaling of seven points (from 0 through 6), with 0 representing sypmtoms that are not present and 6 being the most severe symptoms. When completed, the sum of each individual item is taken to create an overall score.~Overall scores:~0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|Measured over 6 months||||units on a scale||Standard Deviation|Mean
1229475|NCT00667563|Primary|Number of Patients With a Significant Increase in HIV Viral Load|Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions|Screening/week 0, weeks, 2, 10, 26 and 52||||participants|||Number
1229433|NCT00667745|Primary|Number of Necessary Medication Adjustments|"Metric Definition (Necessary Clinical Adjustments (NCA)): Medication adjustments to reduce symptoms, optimize treatment response and functioning, or to address intolerable side effects. This was determined with the Medication Recommendation Tracking Form (MRTF), a novel method for capturing physician prescribing behavior and clinical decision making.~Range: whole numbers~Relevant time points: Weeks 2, 4, 6, 8, 12, 16, 20, and 24."|Measured over 6 months||||Adjustments||Standard Deviation|Mean
1229434|NCT00667745|Primary|Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score|"Scale: Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Construct: This scale holistically measures severity of a participant’s depression, mania, and overall illness.~Range: 0- not assessed, 1-normal (not at all ill), 2- borderline mentally ill, 3- mildly ill, 4- moderately ill, 5- markedly ill, 6- severely ill, 7- among the most extremely ill patients."|Relevant time points: baseline and week 24||||units on a scale||Standard Deviation|Mean
1229435|NCT00667732|Secondary|The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment|efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%|After 24 weeks of randomized treatment|Per protocol, all participants who completed treatment|||percentage of participants|||Number
1229436|NCT00667732|Primary|The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment||After 24 weeks of randomized treatment|Intent to treat. All participants randomized to treatment.|||percentage of participants|||Number
1229437|NCT00667693|Secondary|The Number of Patients With Bleeding||From the start of intubation until 24 hours after surgery||||Participants|||Count of Participants
1229438|NCT00667693|Secondary|The Number of Patients With Different Number of Intubation Attempts|We summarized the number of patients with one, two or three intubation attempts.|From the start of intubation until 24 hours after surgery||||Participants|||Count of Participants
1229439|NCT00667693|Secondary|Successful Intubation on the First Attempt|The count number of successful intubation on the first attempt|From the start of intubation until 24 hours after surgery||||Participants|||Count of Participants
1229440|NCT00667693|Secondary|Ease of Intubation|Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation|From the start of intubation until 24 hours after surgery||||units on a scale||Standard Deviation|Mean
1229441|NCT00667693|Primary|Time to Intubation|time between sufficient muscle relaxant and placement of intubation tube|time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds||||seconds||Inter-Quartile Range|Median
1229442|NCT00667615|Secondary|Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation.|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|through study completion, an average of 1 year||||percentage of participants with CR|||Number
1229443|NCT00667615|Primary|Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma|Maximum Tolerated Dose (MTD) of Vorinostat reflects the highest dose of Ridaforolimus and Vorinostat that did not cause a new Grade 2 toxicity in >= 50% of participants|through study completion, an average of 1 year||||mg/m2|||Number
1229444|NCT00667602|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination|"Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups.~safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups"|From day 1 to day 7 postvaccination|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1229445|NCT00667602|Secondary|Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y|"Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y.~Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.|||Titers||95% Confidence Interval|Geometric Mean
1229446|NCT00667602|Secondary|Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C|"Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C."|1 month postvaccination.|Analysis was done on PP set.|||Titers||95% Confidence Interval|Geometric Mean
1229447|NCT00667602|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y|"Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.~Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
1229476|NCT00667563|Primary|Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28|Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline|Week 28|Per-protocol population with undetectable HPV-16 levels at baseline|||participants|||Number
1229448|NCT00667602|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C|"Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C."|1 month postvaccination.|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
1229449|NCT00667602|Secondary|Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y|Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).|6-18 months postvaccination.|Analysis was done on PP set (only for subjects enrolled in Australia).|||Titers||95% Confidence Interval|Geometric Mean
1229450|NCT00667602|Secondary|Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C|Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).|1 month postvaccination and 6-18 months postvaccination.|Analysis was done on PP set (subjects enrolled in Australia).|||Titers||95% Confidence Interval|Geometric Mean
1229451|NCT00667602|Secondary|Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y|Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).|1 month postvaccination 6-18 months postvaccination|Analysis was done on PP set (persistence subset).|||Percentages of subjects||95% Confidence Interval|Number
1229452|NCT00667602|Secondary|Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C|Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).|1 month postvaccination and 6-18 months postvaccination.|Analysis was done on PP set (persistence subgroup).|||Percentages of subjects||95% Confidence Interval|Number
1229453|NCT00667602|Secondary|Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)|"To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age.~Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL."|1 month postvaccination|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
1229454|NCT00667602|Secondary|Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)|"The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed.~For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration < LLQ) is defined as post-vaccination antibody concentration >= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration >=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration.~Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.~Polio type 1, 2 and 3: bNT (neutralization test) with >=1:8.~HepB (HBV): primary endpoint ELISA >=10mU/mL.~PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL."|1 month postvaccination|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
1229455|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y|"The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C.~The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y."|1 month postvaccination|Analysis was done on PP set.|||Titers||95% Confidence Interval|Geometric Mean
1229456|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y|Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.|1 month postvaccination|Analysis was done on PP set.|||Titers||95% Confidence Interval|Geometric Mean
1229457|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.|1 month postvaccination|Analysis was done on PP set.|||Titers||95% Confidence Interval|Mean
1229458|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y|"Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y.~Serogroup C is not shown here as it is shown in other outcome measures."|1 month postvaccination.|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
1229477|NCT00667563|Primary|Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count|Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests|Screening/Week 0, Weeks 2, 10, 26, and 52.|Intent-to-treat|||participants|||Number
1229571|NCT00667251|Secondary|Time to CNS Metastases at the Time of First Progression||From randomization to CNS metastases at time of first progression, assessed up to 39 months.||||Months||Full Range|Median
1229459|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y|"Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
1229460|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.|1 month postvaccination|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
1229461|NCT00667602|Primary|Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.|1 month postvaccination|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
1229462|NCT00667589|Secondary|Change in Skindex-16 Total Score Between Baseline and 2 Weeks|The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 2 weeks.|baseline and 2 weeks|Results for one subject from the Tazarotene 0.1% cream arm and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not completed a Skindex-16 questionnaire at 2 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.|||units on a scale||Standard Deviation|Mean
1229463|NCT00667589|Primary|Change in Skindex-16 Total Score Between Baseline and 8 Weeks|The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 8 weeks.|baseline and 8 weeks|Results for subjects from the fluocinonide 0.05% cream arm, subjects from the Tazarotene 0.1% cream arm, and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not complete a Skindex-16 questionnaire at 8 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.|||units on a scale|||Number
1229464|NCT00667576|Secondary|Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL||Through Week 13|Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH values ≤ 180 pg/mL. Missing data were not imputed.|||days||Standard Deviation|Mean
1229465|NCT00667576|Secondary|Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values||Through Week 13|Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH decreases of ≥ 50% from baseline. Missing data were not imputed.|||days||Standard Deviation|Mean
1229466|NCT00667576|Secondary|Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level||Through Week 13|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated subjects, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.|||Percentage of participants|||Number
1229467|NCT00667576|Secondary|Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.|||Percentage of participants|||Number
1229468|NCT00667576|Secondary|Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.|||pg/mL||95% Confidence Interval|Mean
1229469|NCT00667576|Other Pre-specified|Percentage of Subjects With Hyperphosphatemia|Hyperphosphatemia was defined as at least 2 consecutive phosphorus values ≥ 7.0 mg/dL|Through Week 13|Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.|||Percentage of participants|||Number
1229470|NCT00667576|Other Pre-specified|Percentage of Subjects With Hypercalcemia|Hypercalcemia was defined as at least 1 adjusted calcium value > 11.5 mg/dL or at least 2 consecutive adjusted calcium values ≥ 11.0 mg/dL|Through Week 13|Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.|||Percentage of participants|||Number
1229471|NCT00667576|Primary|Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.|||Percentage of participants|||Number
1229472|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-18|Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline|28 weeks|Per-protocol population of participants with undetectable HPV-18 antibodies at baseline|||participants|||Number
1229473|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-11|Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline|28 weeks|Per-protocol population of participants with undetectable antibodies for HPV-11 at baseline|||participants|||Number
1229479|NCT00667511|Primary|Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.|The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.|Study Week 20|Includes all patient reported treatments.|||events per 100 treatments|Participants||Number
1229480|NCT00667511|Primary|Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.|The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval).|Study Week 20|Includes all electronically captured treatments.|||percentage of successful treatments|Participants|95% Confidence Interval|Number
1229481|NCT00667459|Secondary|Change of General Health Status -- SF-36 MCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable MCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.|||units on a scale||Standard Deviation|Mean
1229482|NCT00667459|Secondary|Change of General Health Status -- SF-36 PCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable PCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.|||units on a scale||Standard Deviation|Mean
1229483|NCT00667459|Secondary|Change of Arm Pain Score From Baseline|"Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline."|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain score at both baseline and 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.|||units on a scale||Standard Deviation|Mean
1229484|NCT00667459|Secondary|Change of Neck Pain Score From Baseline|"Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to100) was the product of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline."|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.|||units on a scale||Standard Deviation|Mean
1229485|NCT00667459|Secondary|Change of Neck Disability Index Score From Baseline|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.|||units on a scale||Standard Deviation|Mean
1229486|NCT00667459|Secondary|Rate of Secondary Surgery at Index Level|Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of patients who had secondary surgeries at index level.|24 months post-operation|For this endpoint, the analysis consists of all subjects in the primary analysis dataset with 280 subjects in the investigational control and 265 subjects in the control group.|||percentage of participants|||Number
1229487|NCT00667459|Secondary|Hospital Stay||During the time of hospital stay, average of 1 day.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for hospital stay, which leads to 280 subjects in the investigational group and 265 subjects in the control group.|||days||Standard Deviation|Mean
1229488|NCT00667459|Secondary|Blood Loss||During the time of operation, approximately 1.5 hours.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for blood loss, which leads to 278 subjects in the investigational group and 263 subjects in the control group.|||ml||Standard Deviation|Mean
1229489|NCT00667459|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, approximately 1.5 hrs.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for operative time, which leads to 280 subjects in the investigational group and 265 subjects in the control group.|||hrs||Standard Deviation|Mean
1229572|NCT00667251|Secondary|Overall Survival|OS median follow-up not achieved; estimated with quartile estimates|From randomization to death from any cause, assessed up to 44 months.|two subpopulations: ITT (n=652) and HER2+ (n=537)|||Months||Inter-Quartile Range|Median
1235154|NCT00619957|Secondary|Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
1229490|NCT00667459|Secondary|Gait Success Rate|Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.|||percentage of participants|||Number
1229491|NCT00667459|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.|||percentage of participants|||Number
1229492|NCT00667459|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.|||percentage of participants|||Number
1229493|NCT00667459|Secondary|Arm Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.|||percentage of participants|||Number
1229494|NCT00667459|Secondary|Neck Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.|||percentage of participants|||Number
1229495|NCT00667459|Secondary|Rate of Disc Height Success|Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 224 subjects in the investigational group and 164 subjects in the control group.|||percentage of participants|||Number
1229496|NCT00667459|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.|||percentage of participants|||Number
1229497|NCT00667459|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.|||percentage of participants|||Number
1229498|NCT00667459|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative;~Maintenance or improvement in neurological status;~Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of “Postoperative Height - 6 Week Postoperative Height ≥ -2mm”;~No serious adverse event classified as implant associated or implant/surgical procedure associated; and~No secondary surgical procedure classified as a failure."|24 months|The primary analysis dataset for this study consists of all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 226 investigational subjects and 171 control subjects.|||percentage of participants|||Number
1229499|NCT00667446|Secondary|Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age|"Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula:~(BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline)."|Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36|Intention-to-treat with available bone age data. N = participants with available data at each time point.|||ratio||Standard Deviation|Mean
1229500|NCT00667446|Secondary|Change From Baseline in Growth Rate|Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.|Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36|Intention-to-treat with available growth rate data. N = participants with available data at each time point.|||cm/year||Standard Deviation|Mean
1229501|NCT00667446|Secondary|Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)|The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.|Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36|Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1229502|NCT00667446|Secondary|Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)|The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.|Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36|Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1229503|NCT00667446|Secondary|Mean Peak-stimulated Luteinizing Hormone Concentration by Visit|Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.|Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36|Intention-to-treat. N = the number of participants with available data at each time point.|||mIU/mL||Standard Deviation|Mean
1229504|NCT00667446|Secondary|Percentage of Male Participants With Suppression of Basal Testosterone|The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36.|Day 1, Months 3, 6, 9, 12, 24, 30, and 36|Intention-to-treat male population. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1229505|NCT00667446|Secondary|Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)|"The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.~The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36."|Months 6, 9, 12, 24, 30, and 36|Intention-to-treat female population. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1229506|NCT00667446|Secondary|Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)|"The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.~The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36."|Day 1, Months 3, 6, 9, 12, and 24|Intention-to-treat female population. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1229507|NCT00667446|Primary|Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone|Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.|Day 1, Months 6, 12, 24, and 36|Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, & did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1229508|NCT00667420|Secondary|Overall Survival|Overall survival (OS) is the duration from start of treatment to time of death from any cause.|duration from enrollment to death (up to 6 years)||||months||95% Confidence Interval|Median
1229509|NCT00667420|Secondary|Pathologic Complete Response Rate|For patients who undergo complete resection, those who have no evidence of residual viable tumor in the surgical specimen will be declared to have achieved a complete pathologic response (pCR), and the overall percentage of patients with pCR will be determined.|at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)||||participants|||Number
1229510|NCT00667420|Secondary|Progression-Free Survival|measured from the first day of treatment to the day when conclusive evidence of new disease is found|up to 72 months|We enrolled 17 patients|||months||Standard Deviation|Mean
1229511|NCT00667420|Secondary|R0 Resection Rate|percentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection|time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy||||percentage of participants|||Number
1229514|NCT00667394|Primary|Progression-free Survival at 6 Months|Percentage of participants with progression free survival at 6 months. Progression is defined as a 25% increase in the sum of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease), clear worsening of any evaluable disease, appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months||||Percentage of participants||95% Confidence Interval|Median
1229515|NCT00667381|Other Pre-specified|Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations|Patients found to have femoral artery bifurcations occurring over the femoral head were prospectively defined as having a high femoral bifurcation. This subgroup was prespecified for analysis during the trial designed, as it was suspected that operators would have particular difficulty inserting the sheath accurately in this population.|At angiogram analysis||||participants|||Number
1229516|NCT00667381|Secondary|Number of Participants With Vascular Complications|"Vascular complications were defined as vessel thrombosis, dissection, blood transfusion, hematoma > 5cm diameter, unexplained bleeding with a drop in Hgb >4 g/dL, or access site bleeding with drop in Hgb >3 g/dL.~Outcome was assessed by chart review, and clinical or telephone followup at 30 days. Medical records were adjudicated by a blinded independent review committee."|Immediate and up to 1 month after procedure.||||participants|||Number
1229517|NCT00667381|Secondary|Number of Patients With Accidental Femoral Venipunctures.|"Number of patients with any femoral venipunctures where an insertion was not intended, i.e. excluding patients with planned right heart catheterization. Multiple accidental venipunctures were not double counted.~Number of attempts and venipunctures were not recorded in 1 control and 1 ultrasound patient, so the denominator is 500 control patients and 502 ultrasound patients."|Immediate||||participants|||Number
1229518|NCT00667381|Secondary|Time to Successful Sheath Insertion.|"Time was measured from first fluoroscopy of the femoral head (control group), or first application of the ultrasound probe (ultrasound group), until successful sheath insertion.~Time was not recorded for 1 control patient, and 1 ultrasound patient, these patients were excluded from this analysis but included for other analyses."|Immediate||||seconds||Standard Deviation|Mean
1229519|NCT00667381|Primary|Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography|"Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses.~Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers."|Immediately, during procedure.||||participants|||Number
1229520|NCT00667368|Secondary|Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months|Percentage of women testing positive for BV at any follow-up visit. The outcome of BV status was determined by self-collected vaginal swab specimens that were evaluated by the Nugent criteria. A Nugent score of 7-10 indicates positive for BV.|2, 4, 6, 8, 10, 12 months after enrollment|All randomized participants|||percentage of participants|||Number
1229521|NCT00667368|Primary|One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment|Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.|At 4, 8, and 12 months after enrollment.||||Number infections per 100 person-years||95% Confidence Interval|Number
1229522|NCT00667355|Secondary|Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These are summarized in a physical component summary (PCS) and mental component summary (MCS) score. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=lowest level of functioning; 100=highest level of functioning).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||units on scale||95% Confidence Interval|Mean
1229523|NCT00667355|Secondary|Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)|The number of tender or painful joints among 23 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender or painful joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender or painful joints) to 46 (worst possible score; all joints tender or painful).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||TJC||95% Confidence Interval|Mean
1229524|NCT00667355|Secondary|Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)|The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||SJC||95% Confidence Interval|Mean
1229525|NCT00667355|Secondary|Mean Change From Baseline in Nocturnal Pain|Nocturnal pain assessed by subjects using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = no pain and 100 = worst possible pain).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||mm on scale||95% Confidence Interval|Mean
1229526|NCT00667355|Secondary|Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||units on a scale||95% Confidence Interval|Mean
1229528|NCT00667355|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total score ranging from 0 to 10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||units on scale||95% Confidence Interval|Mean
1229529|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission|Partial remission is defined as a score of less than 20 units (on a scale of 0–100; 0=no disease activity and 100=high disease activity) in each of the 4 Assessments in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
1229530|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = at least 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
1229531|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains (each domain measured on a 0 - 100 scale [0 = no disease activity; 100 = high disease activity]).|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
1229532|NCT00667355|Secondary|Mean Change From Baseline in C-Reactive Protein (CRP)|CRP is a marker of inflammation and measured in mg/dL. A higher level is consistent with inflammation.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||mg/dL||95% Confidence Interval|Mean
1229533|NCT00667355|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS subjects. Utilizing a VAS of 0–100 mm (0=easy, 100=impossible), subjects answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on last observation carried forward (LOCF).|||mm on scale||95% Confidence Interval|Mean
1229534|NCT00667355|Secondary|Mean Change From Baseline in Total Back Pain|Subject assessed his/her back pain by using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = no pain and 100 = most severe pain).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||mm on scale||95% Confidence Interval|Mean
1229535|NCT00667355|Secondary|Mean Change From Baseline in Patient's Global Assessment of Disease Activity|Subject's assessment of disease activity using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = none and 100 = severe).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||mm on scale||95% Confidence Interval|Mean
1229536|NCT00667355|Secondary|Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)|BASDAI is a validated self assessment tool used to determine disease activity in subjects with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
1229537|NCT00667355|Secondary|Number of Subjects Achieving ASAS 70|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = at least 70% improvement (vs. baseline) and an absolute improvement ≥ 30 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
1229538|NCT00667355|Secondary|Number of Subjects Achieving ASAS 50|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = at least 50% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
1229539|NCT00667355|Secondary|Number of Subjects Achieving ASAS 20|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on non-responder imputation (NRI), for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
1229586|NCT00666978|Secondary|Number of Participants for Each CYP2B6 Allele|We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.|Week 3||||Participants|||Count of Participants
1235155|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 24, ITT Population.||Baseline to Month 24|ITT Population|||percent||95% Confidence Interval|Least Squares Mean
1229540|NCT00667355|Primary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = at least 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0 - 100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Week 12|For all non-responder imputation (NRI) analyses, subjects with a missing value at a visit were imputed as a non-responder for that visit. Observed cases is based on a total of 40 subjects analyzed (vs. 41 subjects for the study and all other analysis sets) due to 1 subject who discontinued prior to Week 12.|||Subjects|||Number
1229541|NCT00667342|Other Pre-specified|Mean Duration of Neuropathic Pain Medication|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months||||Weeks|Number of Surgeries|Standard Deviation|Mean
1229542|NCT00667342|Other Pre-specified|Median Duration of Neuropathic Pain Medication|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication.|||Weeks|Number of Surgeries|Full Range|Median
1229543|NCT00667342|Other Pre-specified|Mean Duration of Neuropathic Pain|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication.|||Weeks|Number of Surgeries|Standard Deviation|Mean
1229544|NCT00667342|Other Pre-specified|Median Duration of Neuropathic Pain|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had definitive surgery (either limb sparing or/and amputation), experienced neuropathic pain (NP) and were treated for NP until resolution of NP symptoms and off NP medications.|||Weeks|Number of Surgeries|Full Range|Median
1229545|NCT00667342|Other Pre-specified|Number of Participants With Neuropathic Pain (NP) Following Surgery|Of the 43 participants enrolled on this trial, 37 met criteria for evaluation of neuropathic pain (NP) following definitive surgery. The 37 participants underwent 38 surgeries: one participant had a limb-sparing surgery followed by an amputation surgery. Six of 43 participants were excluded from evaluation for NP: 1 due to deep vein thrombosis, 2 removed from study prior to surgery, 1 removed immediately after surgery to receive radiation therapy, 1 had non-extremity osteosarcoma, and 1 patient had a fibula resection. Patients were followed for neuropathic pain daily for the first week postoperatively and weekly for up to 6 months postoperatively.|Up to 6 months postoperatively||||participants|Number of Surgeries||Number
1229546|NCT00667342|Secondary|Difference Between Good and Poor Response by SUVmax|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|One participant with no histologic response but with evaluable imaging was excluded.|||(unitless)||Standard Error|Mean
1229547|NCT00667342|Secondary|P95 of Ktrans by Good and Poor Response|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. P95 denotes the level of each kinetic parameter exceeding 95% of its values in each tumor.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.|||min(-1)||Standard Error|Mean
1229548|NCT00667342|Secondary|Ktrans by Good and Poor Response|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.|||min(-1)||Standard Error|Mean
1229549|NCT00667342|Secondary|Histologic Response by Number of Participants|The association of interested variables with response was checked with the Wilcoxon rank-sum test. The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.|||Participants|||Count of Participants
1229550|NCT00667342|Secondary|Mean Ve|The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points|||(unitless)||Standard Deviation|Mean
1229551|NCT00667342|Secondary|Mean Vp|The fractional blood plasma volume (Vp) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points|||(unitless)||Standard Deviation|Mean
1229552|NCT00667342|Secondary|Mean Ktrans|The volume transfer constant (Ktrans) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points|||min(-1)||Standard Deviation|Mean
1229553|NCT00667342|Secondary|2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol.|The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here.|After all patients have completed therapy, up to 2 years after last patient is enrolled|OS2008 Localized Resectable Disease group had 31 participants: 7 were expired and 24 still alive|||probability||95% Confidence Interval|Number
1229554|NCT00667342|Secondary|2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol.|The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here.|After all patients have completed therapy, up to 2 years after last patient is enrolled|OS2008 Localized Resectable Disease group had 31 participants: 14 had events, 17 had no events.|||probability||95% Confidence Interval|Number
1229555|NCT00667342|Secondary|2-Year Overall Survival (OS) of Patients With Osteosarcoma|Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.|After all patients have completed therapy, up to 2 years after last patient is enrolled|All the 42 evaluable participants in this study had osteosarcoma, of which 12 died and 20 were still alive as of 05/04/2015.|||probability||95% Confidence Interval|Number
1229556|NCT00667342|Secondary|2-Year Event Free Survival (EFS) of Patients With Osteosarcoma|Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.|After all patients have completed therapy, up to 2 years after last patient is enrolled|All the 42 evaluable participants were included in this analysis.|||probability||95% Confidence Interval|Number
1229557|NCT00667342|Secondary|Histologic Response by Stratum|"The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133.~Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor).~The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done."|After 6 cycles of chemotherapy, up to 1 year after the start of therapy|All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants.|||participants|||Number
1229558|NCT00667342|Primary|3-Year Event Free Survival|To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate.|After all patients have completed therapy, up to 4 years after last patient is enrolled||||Probability||95% Confidence Interval|Number
1229559|NCT00667342|Primary|Number of Participants With Unacceptable Toxicity|"Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma.~The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications.~A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity."|After all patients have completed therapy, up to 1 year after last patient is enrolled|Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.|||participants|||Number
1229560|NCT00667277|Secondary|Number of Cycles|Number of cycles of bevacizumab received. Patients received bevacizumab as a single agent at a dose of 15 mg/kg intravenously on Day 1 of a 21-day cycle.|2 years||||cycles||Standard Deviation|Mean
1229561|NCT00667277|Primary|Reason for Therapy Discontinuation|"Patient outcomes for myelofibrosis patients treated on a single agent bevacizumab.~The two subjects who withdrew consent prior to initiation of therapy are included in the patient refusal category."|2 years||||participants|||Number
1229562|NCT00667251|Secondary|Economic Evaluation, Including Health Utilities, as Measured by the EQ-5D Questionnaire, and Healthcare Utilization||Not available at this time|||||||
1229563|NCT00667251|Secondary|Effects of Changes in Biomarkers on Clinical Outcomes||Not available at this time|||||||
1229564|NCT00667251|Secondary|Quality of Life as Measured by the EORTC QLQ-C30 Global Score From Baseline to 12 Weeks|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The global score ranges from 0-100, with higher values representing a better quality of life. At 12 weeks: Group mean difference between arms|12 weeks||||Score on global scale||Standard Deviation|Mean
1229565|NCT00667251|Secondary|Clinical Benefit Response Rate (HER2/Neu+))|Best overall response of CR, PR, or stable disease at end of week 24.|24 weeks||||Participants|||Number
1229566|NCT00667251|Secondary|Clinical Benefit Response Rate (ITT)|Best overall response of CR, PR or stable disease at end of week 24.|24 weeks||||Participants|||Number
1229567|NCT00667251|Secondary|Overall Objective Response Rate (Complete or Partial) HER2/Neu+|Response determined by RECIST V 1.0|Median follow-up of 21.5 months.||||Participants|||Number
1229568|NCT00667251|Secondary|Overall Objective Response Rate (Complete or Partial) ITT|Patients included in this assessment must have had at least one measurable lesion at baseline, and had at least one RECIST re-evaluation after baseline while on protocol therapy, prior to, or on, date of progression. Best overall response was classified to be Complete Response (CR) or Partial Response (PR).|4 years||||Participants|||Number
1229569|NCT00667251|Secondary|CNS Metastases at the Time of Progression (HER2+)||Incidence rate of CNS mestastes at first progression, assessed up to 39 months|151 patients with metastases assessed for CNS metastases; 128 patients with metastases assessed for CNS metastases.|||CNS metastases|||Number
1229573|NCT00667251|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From randomization to RECIST V 1.0 progression or death assessed up to 39 months.|two subpopulations: ITT (n=652) and HER2+ (n=537)|||Months||Full Range|Median
1229574|NCT00667225|Secondary|Mean Change in Each Group Measured by Lesion Count.|Average change in number of lesions from baseline to 8 weeks|Baseline compared to 8 weeks (5 visits)||||lesions||Standard Deviation|Mean
1229575|NCT00667225|Primary|Patients Experiencing Complete Clearance of All Molluscum Lesions.||Baseline compared to 8 weeks (5 visits)|We used a power calculation to estimate the number of patients needed to detect a clinically significant result.|||Participants|Participants||Number
1229576|NCT00667186|Secondary|Percentage Consenting to Testing|Percentage of those successfully offered testing who consent to testing|3 years|the number consenting to testing divided by the number offered testing|||percentage of offered testing who consen|||Number
1229577|NCT00667186|Primary|Percentage of Tested Participants Newly Diagnosed as HIV Infected|Percentage of tested participants newly diagnosed as HIV infected|3 years|participants analyzed is restricted to the participants that consented to testing|||percentage of tested that are positive|||Number
1229578|NCT00667095|Secondary|Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|Baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||participants|||Number
1229579|NCT00667095|Secondary|Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. this score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||participants|||Number
1229580|NCT00667095|Secondary|Change in Urogenital Distress Inventory (UDI-6)|"The UDI-6 measures the effect of urinary incontinence on quality of life. It consists of 6 items, each with the response scale from 0=Not at all to 3=Greatly. The scores can range from 0 to 18; a low score indicates less impact of incontinence on quality of life."|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||units on a scale||Standard Deviation|Mean
1229581|NCT00667095|Secondary|Change in International Consultation on Incontinence Questionnaire – Short Form Score (ICIQ-SF)|The ICIQ-SF provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire has 4 items and the score can range from 0 to 21, with greater values indicating increased severity of symptoms and lower quality of life.|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||units on a scale||Standard Deviation|Mean
1229582|NCT00667095|Secondary|Change in Incontinence Impact Questionnaire Short Form (IIQ-7)|"The IIQ-7 measures the effect of urinary incontinence on quality of life. It is comprised of 7 items, each with the response scale from 0=Not at all to 3=Greatly. The scores can range from 0 to 21; a low score indicates less impact of incontinence on quality of life."|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DSMO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||units on a scale||Standard Deviation|Mean
1229583|NCT00667095|Primary|Change in Incontinence Quality of Life (I-QoL) Score|"The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from ‘1= Extremely’ to ‘5= Not at all’.~A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a ‘Scale score’ ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items – lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life."|Baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DMSO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||units on a scale||Standard Deviation|Mean
1229584|NCT00667017|Primary|Response Rate - Cutaneous T Cell Lymphoma (CTCL)|Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.|Once a week for seven weeks|Consent Withdrawn After Treatment Started Pt withdrew from treatment due to side effects.||||||
1229585|NCT00666978|Secondary|Number of Slow and Fast Metabolizers by Genotype|"Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.~Slow metabolizers have any reduction or loss of function variant. Fast metabolizers are *1/*1 genotype by exclusion."|Week 0|This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm. Blood was unable to be analyzed for CYP2A6 genotype for 6 participants.|||Participants|||Count of Participants
1229587|NCT00666978|Secondary|Number of Slow and Fast Metabolizers by Metabolite Ratio|"Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31.~The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.~Blood samples were collected for 3HC/COT ratio at Week 0."|Weeks 0|This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.|||Participants|||Count of Participants
1229588|NCT00666978|Primary|Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months|Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.|6 months||||Participants|||Count of Participants
1229589|NCT00666965|Secondary|IRLS Each Parameter|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.~The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown."|Baseline, every two weeks|FAS, LOCF|||Percentage of Participants|||Number
1229590|NCT00666965|Secondary|Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)|Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing. SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1229591|NCT00666965|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|"PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement.~The data at 6 weeks after dosing is shown."|Baseline, every two weeks|FAS, LOCF|||Percentage of Participants|||Number
1229592|NCT00666965|Secondary|Patient Global Impression (PGI) Improvement|The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7.|Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.|FAS, LOCF|||Percentage of Participants|||Number
1229593|NCT00666965|Secondary|Clinical Global Impression (CGI) Severity|"CGI is a clinician-reported scale for assessing severity of illness.~The sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients."|Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.|FAS, LOCF|||Percentage of Participants|||Number
1229594|NCT00666965|Primary|Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score.~The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, end of maintenance period at 6 weeks|Full analysis set (FAS), last observation carried forward (LOCF)|||scores on a scale||Standard Deviation|Mean
1229595|NCT00666926|Secondary|Caspase-3|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; sequential activation of caspases plays a central role in the execution-phase of cell apoptosis. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.||||||
1229596|NCT00666926|Secondary|Phospho-SRC (pSRC)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; SRC proto-oncogenes are regulators of growth and differentiation of eukaryotic cells and are implicated in development of human tumors. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose; on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.||||||
1229597|NCT00666926|Secondary|Phosphorylated Mitogen Activated Pathway Kinase (pMAPK)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; MAPK regulates activities of several transcription factors. A defect in MAPK pathway leads to uncontrolled cell growth. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.||||||
1229719|NCT00666406|Secondary|Incremental Recovery. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log_e -linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
1229598|NCT00666926|Secondary|Phosphorylated Focal Adhesion Kinase (pFAK)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; FAK is overexpressed in a variety of human cancers. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.||||||
1229599|NCT00666926|Secondary|Percentage of Participants With Best Overall Response as Measured Using the Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from start of treatment (Tx) until disease progression. Complete response: disappearance of all target lesions. Partial response: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD. Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions. Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Baseline up to 12 cycles (cycle=21days)|RECIST response analysis set: all enrolled participants who had an adequate baseline tumor assessment, measureable disease and who started treatment. N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1229600|NCT00666926|Secondary|Apparent Oral Clearance (CL/F): MDZ|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
1229601|NCT00666926|Secondary|Serum Decay Half-life (t 1/2): MDZ|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||hours||Standard Deviation|Mean
1229602|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): MDZ||C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||hours||Full Range|Median
1229603|NCT00666926|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): MDZ|AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1229604|NCT00666926|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): MDZ|Area under the serum concentration time-curve from zero to the last measured concentration.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1229605|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): MDZ||C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1229606|NCT00666926|Secondary|Observed Accumulation Ratio (Rac): PF-00562271 C1.D14|Rac was the ratio of the Day 14 AUC0-tau (0 hour to last dose interval) and AUC during the corresponding time period after the lead-in dose (AUCtau C1.D14/AUCtau C0.D1).|Escalation (Esc) cohort: C0.D1: 0 hr, and 0.5, 1, 2, 4, 6, 7,12 hrs post dose; Expansion (Exp) cohort: C0:D1: 0 hr, and 1, 2, 4, 8 hrs post dose; Esc and Exp cohorts: C1.D14 0 hour, and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1229607|NCT00666926|Secondary|Area Under the Curve From Time Zero to the End of the Dosing Interval (AUCtau): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1229608|NCT00666926|Secondary|Minimum Observed Serum Trough Concentration (Cmin): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1229609|NCT00666926|Secondary|Apparent Oral Clearance (CL/F): PF-00562271 C0. D1, C1.D1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1229720|NCT00666406|Secondary|Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Increase in factor VIII concentration from pre- to post-infusion.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
1229610|NCT00666926|Secondary|Serum Decay Half-life (t 1/2): PF-00562271 C0.D1, C1.D1|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||hours||Standard Deviation|Mean
1229611|NCT00666926|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): PF-00562271 C0.D1, C1.D1|AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1229612|NCT00666926|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-00562271 C0.D1, C1.D1|Area under the serum concentration time-curve from zero to the last measured concentration; nanograms multiplied by hours per milliliters (ng*hr/mL).|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1229613|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||hours||Full Range|Median
1229614|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C0.D1, C1.D1||Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||hours||Full Range|Median
1229615|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1229616|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): PF-00562271 C0.D1, C1.D1||Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 morning (am) dose|Pharmacokinetic (PK) parameter analysis set: all participants with at least 1 dose of study treatment and at least 1 of the PK parameters of interest estimated in at least 1 treatment period. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1229617|NCT00666926|Primary|Percentage of Participants With Tumor Metabolic Response (Reduction of ≥15%) in Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)|Metabolic response demonstrated in any tumor reduction of ≥15% in tumor FDG standardized uptake value (SUV) in Cycle 1; based on the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Participant must have had a baseline PET with at least 1 tumor lesion demonstrating an FDG SUV of ≥5.|Baseline, C1.D14|Participants in the 125 mg BID expansion cohort with at least 1 dose of study treatment, at least 1 lesion with an SUV ≥5 at baseline, and an on-study PET assessment C1.D14 (Day 13 up to Day 17).|||percentage of participants||90% Confidence Interval|Number
1229618|NCT00666926|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)|At least possibly attributable to study treatment (Tx): Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or Gr 3 febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); Gr ≥3 non-hematologic toxicity despite adequate medical intervention; Gr ≥3 confirmed prolonged QTc interval (>500 milliseconds [msec]); confirmed cardiac troponin I ≥99 percentile of reference range; Tx related toxicities with failure to receive ≥18 days Tx in 21-day cycle or inability to resume current dose level ≤14 days.|Baseline up to Cycle 1 Day 21 (C1.D21)|Safety analysis set: All enrolled participants who started treatment.|||participants|||Number
1229619|NCT00666848|Primary|Change in MAP During Sitagliptin|Mean change in mean arterial pressure in response to placebo or enalapril in the presence of 5 days of sitagliptin 100mg/day|just prior to drug administration and 8 hours following treatment||||mmHg||Standard Deviation|Mean
1229620|NCT00666848|Primary|Change in MAP During Placebo|The change in mean arterial pressure (MAP) in response to placebo or enalapril after pretreatment with 5 days of placebo|just prior to drug administration and 8 hours after drug administration||||mmHg||Standard Deviation|Mean
1229621|NCT00666835|Secondary|Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population|The mean absolute change in Hb levels between the screening/baseline period and the evaluation period was analyzed for the intent-to-treat (ITT) population in the same way as the primary efficacy endpoint. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between HX575 epoetin alfa Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL].|28 weeks|Intent-to-treat population (ITT): all randomized patients who received at least one dose of the study medication and for whom at least one post-baseline value of the primary endpoint Hb was available. A prerequisite to be included in the ITT population was that they were treated for four weeks with Hb values available during this period.|||g/dL||Standard Error|Least Squares Mean
1229622|NCT00666835|Primary|To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.|Primary endpoint was the mean absolute change in Hb level between the screening/baseline and the evaluation period. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period – mean of screening/baseline period) in Hb between epoetin alfa HX575 Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [–0.5 g/dL; 0.5 g/dL]. Primary Endpoint was analyzed based on intent-to-treat (ITT) population.|28 weeks|Primary Endpoint was analyzed based on ITT population: all treated patients with a post baseline hemoglobin value.|||g/dL||Standard Error|Least Squares Mean
1229623|NCT00666757|Secondary|Change From Baseline in Weight at Week-12 Endpoint|Mean change from baseline to endpoint in weight|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=370; and Week 12: Duloxetine N=273, SSRI N=284|||kilograms (kg)||Standard Error|Least Squares Mean
1229624|NCT00666757|Secondary|Change From Baseline in Pulse Rate at Week-12 Endpoint|Mean change from baseline to endpoint in pulse rate|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285|||beats per minute (bpm)||Standard Error|Least Squares Mean
1229625|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint|"Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0–100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between score for self and score for average worker in same job. Mean change baseline to endpoint is reported."|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.|||units on a scale||Standard Error|Least Squares Mean
1229626|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint|Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0–100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported.|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.|||hours lost per week||Standard Error|Least Squares Mean
1229627|NCT00666757|Secondary|Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint|Mean change from baseline to endpoint in diastolic blood pressure|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371: and Week 12: Duloxetine N=274, SSRI N=285|||mmHg||Standard Error|Least Squares Mean
1229628|NCT00666757|Secondary|Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint|Mean change from baseline to endpoint in systolic blood pressure|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285|||millimeters of mmercury (mmHg)||Standard Error|Least Squares Mean
1229629|NCT00666757|Secondary|Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283|||units on a scale||Standard Error|Least Squares Mean
1229630|NCT00666757|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=363, SSRI N=370; and Week 12: Duloxetine N=271, SSRI N=283|||units on a scale||Standard Error|Least Squares Mean
1229631|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint|Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100–absenteeism] × [100–presenteeism]). Mean change baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Last Observation Carried Forward.|||dollars||Standard Error|Least Squares Mean
1229632|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint|WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP.|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.|||dollars||Standard Error|Least Squares Mean
1229633|NCT00666757|Secondary|Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=260,SSRI N=267; and Week 12: Duloxetine N=182, SSRI N=192|||units on a scale||Standard Error|Least Squares Mean
1229634|NCT00666757|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283|||units on a scale||Standard Error|Least Squares Mean
1229635|NCT00666757|Secondary|Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)|The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=346, SSRI N=348; and Week 12: Duloxetine N=249, SSRI N=257|||units on a scale||Standard Error|Least Squares Mean
1229636|NCT00666757|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)|The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=211, SSRI N=233; and Week 12: Duloxetine N=156, N=166|||units on a scale||Standard Error|Least Squares Mean
1229637|NCT00666757|Secondary|Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285|||units on a scale||Standard Error|Least Squares Mean
1229638|NCT00666757|Secondary|Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
1229639|NCT00666757|Secondary|Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)|HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274; SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
1229640|NCT00666757|Secondary|Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)|"HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe)."|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
1229641|NCT00666757|Secondary|Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)|HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
1229642|NCT00666757|Secondary|Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and; and Week 12: Duloxetine N=272, SSRI N=283|||units on a scale||Standard Error|Least Squares Mean
1229643|NCT00666757|Secondary|Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]|Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.|Baseline, 12-Weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and Week 12: Duloxetine N=272, SSRI N=283|||Probability of response||Standard Error|Least Squares Mean
1229721|NCT00666406|Secondary|Terminal Half-life. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||hours||90% Confidence Interval|Geometric Mean
1229644|NCT00666757|Secondary|Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]|Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.|Baseline, 12-Weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284|||Probability of response||Standard Error|Least Squares Mean
1229645|NCT00666757|Secondary|Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]|Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] </=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy.|12 weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371 and Week 12: Duloxetine N=272, SSRI N=283|||Probability of remission||Standard Error|Least Squares Mean
1229646|NCT00666757|Secondary|Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)|The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
1229647|NCT00666757|Primary|Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]|Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.|12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284|||Probability of remission||Standard Error|Least Squares Mean
1229648|NCT00666718|Secondary|Number of Injections of Insulin at Week 24||Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||Participants|||Number
1229649|NCT00666718|Secondary|Total Daily Insulin Dose at Endpoint|LSMean values presented were controlled for treatment, country, and baseline HbA1C value.|Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||Units||Standard Error|Least Squares Mean
1229650|NCT00666718|Secondary|Change in Body Weight From Baseline to Week 24|LSMean values presented were controlled for treatment, country, and baseline HbA1C value.|Baseline, Week 24|Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.|||Kilograms (kg)||Standard Error|Least Squares Mean
1229651|NCT00666718|Secondary|Number of Participants With Adverse Events (AE)|A listing of adverse events is located in the Reported Adverse Event module.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.|||participants|||Number
1229652|NCT00666718|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Episodes|Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.|||percentage of participants|||Number
1229653|NCT00666718|Secondary|Rate Of All Self-reported Hypoglycemic Episodes|Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.|||episode/30 days/participant||Standard Error|Least Squares Mean
1229654|NCT00666718|Secondary|Glycemic Variability at Endpoint|LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.|Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||mmol/L||Standard Error|Least Squares Mean
1229655|NCT00666718|Secondary|7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint|LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.|24 weeks|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1229656|NCT00666718|Secondary|Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint||Week 24|Full Analysis Set: All patients who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||Percent of Participants|||Number
1229657|NCT00666718|Secondary|Change From Baseline in HbA1c at Week 12 and Week 24|LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.|Baseline, Week 12, Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||Percent of Glycosylated Hemoglobin||95% Confidence Interval|Least Squares Mean
1229658|NCT00666718|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24|Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.|Baseline, Week 24|Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.|||Percent of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1229659|NCT00666705|Other Pre-specified|Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
1229660|NCT00666705|Primary|Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
1229661|NCT00666705|Other Pre-specified|Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
1229662|NCT00666705|Primary|Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng.hr/mL||Standard Deviation|Mean
1229663|NCT00666705|Primary|Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
1229664|NCT00666705|Primary|Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng.hr/mL||Standard Deviation|Mean
1229665|NCT00666679|Post-Hoc|Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit.|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period in patients who met lung function eligibility criteria at randomization; measurements taken at 1 and 2 weeks contributed to average.|Baseline and 2 Weeks|The analysis was based on a subset of the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug, had a measurement for analysis available in at least one treatment period and met lung function eligibility criteria specifically at the randomization visit.|||L (Liter)||95% Confidence Interval|Least Squares Mean
1229819|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229666|NCT00666679|Other Pre-specified|Change From Baseline in Total Peripheral Blood Eosinophils|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||10^3/microliter||95% Confidence Interval|Least Squares Mean
1229667|NCT00666679|Other Pre-specified|Percentage of Days With Asthma Exacerbations|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period.|2 Weeks|The analysis was based on the Completers Set population which included all randomized patients who took a dose of blinded post randomization study drug (inhaled montelukast or matching placebo) in both treatment periods and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1229668|NCT00666679|Other Pre-specified|Percentage of Days With Asthma Control|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1229669|NCT00666679|Other Pre-specified|Change From Baseline in Total Daily β-agonist Use|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||Puffs||95% Confidence Interval|Least Squares Mean
1229670|NCT00666679|Secondary|Change From Baseline in Nighttime Asthma Symptom Score|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on a subset of the FAS population which included all randomized patients with nighttime symptoms at baseline (score>0), who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1229671|NCT00666679|Secondary|Change From Baseline in Daytime Asthma Symptom Score|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1229672|NCT00666679|Primary|Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L (Liter)||95% Confidence Interval|Least Squares Mean
1229673|NCT00666666|Secondary|Percentage of Patients With Overall PSA < 4.0 ng/mL||3 years||||percentage of participants|||Number
1229674|NCT00666666|Secondary|Percentage of Patients With PSA ≥ 0.2 ng/mL But < 4.0 ng/mL||3 years||||percentage of participants|||Number
1229675|NCT00666666|Primary|Percentage of Patients With Undetectable Prostate-specific Antigen (PSA) (< 0.2 ng/mL) at End of 7 Cycles||3 years||||percentage of participants|||Number
1229676|NCT00666588|Secondary|Feasibility of Stem Cell Quantitation: Percentage of Leukemia Initiation Cells (LIC) Depletion|Descriptive statistics to assess mean +/- standard deviation for the percentage leukemia initiation cells (LIC) depletion.|At baseline and after completion of course 1|Ineligible patients (n=4) are excluded. Patients without available data (n=42) are excluded.|||percentage of LIC depletion||Standard Deviation|Mean
1229677|NCT00666588|Secondary|Protein Expression Assessed by Western Blot|Relative expression of apoptotic and cell cycle proteins will be characterized using descriptive statistics. If differences are noted between pre and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test if the data are non-normally distributed. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.|At baseline, prior to and up to 24 hours after bortezomib treatment|These data will never be collected because the investigators decided not to perform quantitative biologic analysis.||||||
1229678|NCT00666588|Secondary|Proteasome Inhibition Activity|Mean and standard deviation of β1 and β5- Results are ratios (proteasome subunit/β-actin based on loading of 15 µg total protein, normalized to CEM).|At baseline|Ineligible patients (n=4) are excluded. Patients without available data (n=36) are excluded. The data summarized are only at baseline as that is the only data available.|||ratio||Standard Deviation|Mean
1235156|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 12, ITT Population.||Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1229679|NCT00666588|Secondary|NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)|NF-kB activity will be measured as a continuous variable (ng NF-kB/Mg protein). Differences in NF-κB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. We may perform exploratory analyses to determine if single time point measurements, or the difference between time points, correlate with treatment response.|At baseline, prior to and up to 24 hours after bortezomib treatment|Ineligible patients (n=4) are excluded. Patients without available data (n=36) are excluded.|||ng/Mg protein||Standard Deviation|Mean
1229680|NCT00666588|Primary|Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1|Overall response (complete remission [CR] and CR with partial recovery [CRp]) during course 1.|After course 1||||participants|||Number
1229681|NCT00666588|Primary|Dose Limiting Toxicity|Number of participants with dose limiting toxicity.|During Course 1||||participants|||Number
1229682|NCT00666562|Secondary|Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)||At Baseline|This outcome was assessed in all participants,combined irrespective of their randomization. Analysis was not able to be completed for 4 participants.|||ng/mL||Standard Deviation|Mean
1229683|NCT00666562|Secondary|Absolute Change for Baseline of EGCG in Urine Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.|||ng/mL||Standard Deviation|Mean
1229684|NCT00666562|Secondary|Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.|||ng/mL||Standard Deviation|Mean
1229685|NCT00666562|Secondary|Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.|||ng/mL||Standard Deviation|Mean
1229686|NCT00666562|Secondary|Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples||up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 2 participants in Arm III.|||ng/mL||Standard Deviation|Mean
1229687|NCT00666562|Secondary|Serum IGFBP-3 Levels Assessed by ELISA||Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I.|||ng/mL||Standard Deviation|Mean
1229688|NCT00666562|Secondary|Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)||At Baseline|"This outcome was assessed in all participants,combined irrespective of their randomization.~Analysis was not able to be completed on 4 participants."|||ng/mL||Standard Deviation|Mean
1229689|NCT00666562|Secondary|Absolute Change for Baseline From EGCG in Serum Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.|||ng/mL||Standard Deviation|Mean
1229690|NCT00666562|Secondary|Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples||up to 28 days|Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.|||ng/mL||Standard Deviation|Mean
1229691|NCT00666562|Secondary|Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA||Baseline and up to day 28|Analysis was not able to be completed for 2 participants in Arm I.|||ng/mL||Standard Deviation|Mean
1229692|NCT00666562|Secondary|Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry||up to 28 days||||optical density||Standard Deviation|Mean
1229693|NCT00666562|Secondary|Levels of EGCG in Malignant Bladder Tissue||up to 28 days|Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.|||ng/mL||Standard Deviation|Mean
1229694|NCT00666562|Primary|Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)|Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.|up to 28 days||||ng/mL||Standard Error|Mean
1229695|NCT00666536|Secondary|Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||Percentage of Patients|||Number
1229696|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSDBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
1229697|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSSBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
1229698|NCT00666536|Secondary|Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
1229699|NCT00666536|Secondary|Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||Percentage of Patients|||Number
1229700|NCT00666536|Primary|Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
1229701|NCT00666458|Secondary|Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)|Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.|Baseline, Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.|||mmol/L||Standard Error|Mean
1229702|NCT00666458|Secondary|Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)|Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.|Baseline, Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1229703|NCT00666458|Secondary|Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18|Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)|Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement.|||Percentage of Participants|||Number
1229704|NCT00666458|Primary|Hemoglobin A1c (HbA1c) Change From Baseline to Week 18|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline, Week 18|Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations.|||Percent||Standard Error|Mean
1229705|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted CL * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/kg||90% Confidence Interval|Geometric Mean
1229706|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted CL * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/kg||90% Confidence Interval|Geometric Mean
1229707|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted Clearance (CL) * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/kg||90% Confidence Interval|Geometric Mean
1229708|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Computed as weight-adjusted Clearance * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/kg||90% Confidence Interval|Geometric Mean
1229709|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
1229710|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
1229711|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
1229712|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
1229713|NCT00666406|Secondary|Mean Residence Time (MRT). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
1229714|NCT00666406|Secondary|Mean Residence Time (MRT). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
1229715|NCT00666406|Secondary|Mean Residence Time (MRT). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
1229716|NCT00666406|Secondary|Mean Residence Time (MRT). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
1229717|NCT00666406|Secondary|Incremental Recovery. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Increase in factor VIII concentration from pre- to post-infusion|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
1229718|NCT00666406|Secondary|Incremental Recovery. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Increase in factor VIII concentration from pre- to post-infusion|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
1229722|NCT00666406|Secondary|Terminal Half-life. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||hours||90% Confidence Interval|Geometric Mean
1229723|NCT00666406|Secondary|Terminal Half-life. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||hours||90% Confidence Interval|Geometric Mean
1229724|NCT00666406|Secondary|Terminal Half-life. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations (9 to 48 hours).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||hours||90% Confidence Interval|Geometric Mean
1229725|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU/dL||90% Confidence Interval|Geometric Mean
1229726|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU/dL||90% Confidence Interval|Geometric Mean
1229727|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU/dL||90% Confidence Interval|Geometric Mean
1229728|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU/dL||90% Confidence Interval|Geometric Mean
1229729|NCT00666406|Secondary|Systemic Clearance (Cl). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/h/kg||90% Confidence Interval|Geometric Mean
1229730|NCT00666406|Secondary|Systemic Clearance (Cl). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/h/kg||90% Confidence Interval|Geometric Mean
1229731|NCT00666406|Secondary|Systemic Clearance (Cl). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/h/kg||90% Confidence Interval|Geometric Mean
1229732|NCT00666406|Secondary|Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/h/kg||90% Confidence Interval|Geometric Mean
1229733|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
1229734|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
1229735|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
1229736|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|"AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.~FVIII activity measurement"|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
1229737|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
1229766|NCT00666263|Secondary|Rate of Related SAEs Per Infusion|The total number of SAEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.|Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||SAEs per infusion|Infusions||Number
1229738|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
1229739|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
1229740|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. One-Stage Activated Partial Thromboplastin Time (aPTT) -Based Assay Performed at Central Laboratory (Medical University Vienna)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
1229741|NCT00666328|Secondary|The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion||Within 30 minutes of the initiation of study drug infusion|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.|||percent participants|||Number
1229742|NCT00666328|Secondary|Percent Change in Heart Rate During 30 of Initiation of Clevidipine|Multiple timepoints were assessed (minutes 1, 2, 3, 4, 5, 10, 15, 20, 30) for analysis of percent change in heart rate during the initial 30 minutes.|From study drug initiation through each specified timepoint|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses. Data for 33 of the 35 patients in the Safety population had data for the 30 minute time point used for this analysis.|||percent change||Standard Deviation|Mean
1229743|NCT00666328|Secondary|Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine|Additional or alternative antihypertensive agent(s) comprise the use of other antihypertensive agent(s) either with clevidipine (additional) or in place of clevidipine (alternative) for the indication of hypertension from the time of clevidipine initiation to clevidipine termination. For purposes of this analysis, additional or alternative antihypertensive agents did not include oral antihypertensives that were administered in order to transition IV clevidipine-treated patients to oral therapy during the transition period of the study.|Up to 96 hours|The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.|||participants|||Number
1229744|NCT00666328|Secondary|Median Dose of Clevidipine During the Treatment Period|Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment|Up to 96 hours||||milligrams (mg)||Inter-Quartile Range|Median
1229745|NCT00666328|Secondary|Mean Dose of Clevidipine During the Treatment Period|Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment|Up to 96 hours|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.|||milligrams (mg)||Standard Deviation|Mean
1229746|NCT00666328|Secondary|Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine|The percent time that SBP was maintained within the SBP target range (≤160 mmHg to ≥140 mmHg) was summarized for each 24-hour period of monotherapy of clevidipine infusion through 96 hours (0 -≤24 h, 24-≤48 h, 48-≤72 h, 72-≤96 h). For purposes of this analysis, SBP data were available from all mITT patients for the overall infusion period and from 0 to ≤24 hours of infusion; however, data was only available for 8 patients from 24 to ≤48 hours, 4 patients from 48 to ≤72 hours and 1 patient from 72 to ≤96 hours due to the variability in infusion durations >24 hours across patients.|From study drug initiation through termination (up to 96 h)|The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.|||percent time||Standard Deviation|Mean
1229747|NCT00666328|Secondary|Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion|Total AUC-SBP captures the magnitude and duration of SBP either above the upper limit of the target SBP range at 160 mm Hg or below the lower limit of 140 mm Hg and normalized per hour for the duration of clevidipine infusion. A larger value for AUC-SBP indicates greater SBP variability outside the target range.|Duration of the study drug infusion (up to 96 hours)||||mm Hg × min/hr||Standard Deviation|Mean
1229748|NCT00666328|Secondary|Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion|Over the initial 30 minutes of the treatment period, the percent change from baseline (defined as immediately prior to study drug initiation) was summarized descriptively at 1, 2, 3, 4, 5, 6, 7, 10, 15, 20, 25, and 30 minutes after clevidipine initiation. Decreases in SBP from baseline were observed over the course of this time period.|Baseline through 30 minutes post initiation of clevidipine infusion||||percent change in SBP||Standard Deviation|Mean
1229749|NCT00666328|Secondary|Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine|The percentage of patients who reached SBP of ≤160 mmHg within the first 30 minutes of initiation of clevidipine infusion was summarized. If an additional or alternative IV antihypertensive agent and/or oral antihypertensive agent was administered for hypertension prior to a patient achieving SBP≤160 mmHg during the initial 30-minute treatment period, then the patient was considered to have failed to reach this efficacy endpoint.|Within 30 minutes of study drug initiation|Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.|||percent participants||95% Confidence Interval|Number
1229750|NCT00666328|Primary|Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine|The median time, in minutes, was estimated with its two-tailed 95% confidence interval from the time of the initiation of clevidipine infusion until the first observed SBP was achieved in the target range of ≤160 mmHg to ≥140 mmHg within the first 30 minutes of clevidipine treatment. If patients did not reach the blood pressure target range within the first 30 minutes, their data was considered censored at 30 minutes. If another IV and/or oral antihypertensive agent indicated for hypertension was administered less than 30 minutes prior to achieving the endpoint, the data was considered censored at the time when the additional or alternative antihypertensive agent was given.|Within 30 minutes of study drug initiation|Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.|||minutes||95% Confidence Interval|Median
1229751|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.|Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229752|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.|Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229753|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Weight.|Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229754|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Route of Administration.|Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229755|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.|Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229756|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.|Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229757|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.|Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229758|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Age|Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229759|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Gender.|Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229760|NCT00666276|Primary|Number of Participants With Adverse Drug Reactions(ADRs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229761|NCT00666276|Primary|Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.|The adverse drug reaction that have not been listed in Japanese package insert.|Baseline to 8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1229762|NCT00666263|Primary|The Percentage of Participants Reporting One or More Moderate or Severe AEs That Began During Infusion or Within 72 Hours of Completion of an Infusion||Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||percentage of participants|||Number
1229763|NCT00666263|Secondary|The Proportion of Infusions Associated With One or More AEs Related to the Study Product||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||proportion of infusions|Infusions||Number
1229764|NCT00666263|Secondary|The Proportion of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||proportion of infusions|Infusions||Number
1229765|NCT00666263|Secondary|The Proportion of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||proportion of participants|||Number
1229767|NCT00666263|Secondary|Rate of Related AEs Per Infusion|The total number of AEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.|Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||AEs per infusion|Infusions||Number
1229768|NCT00666263|Primary|The Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||percentage of infusions|Infusions||Number
1229769|NCT00666263|Primary|The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||percentage of participants|||Number
1229770|NCT00666263|Primary|Rate of Temporally Associated Adverse Events (AEs) Per Infusion|The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.|Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||Percentage of AEs per infusion|Infusions||Number
1229771|NCT00666263|Primary|Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy’s Neurological Disability Score (GNDS)|GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Proportion of participants|||Number
1229772|NCT00666263|Post-Hoc|Proportion of Participants With at Least a 30% Decline in Relative Grip Strength in the Less Affected Hand (Measured Using a DynEx Digital Dynamometer)|"Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Proportion of participants|||Number
1229773|NCT00666263|Primary|Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs|GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
1229774|NCT00666263|Secondary|Mean Relative Change in Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The VAS measured patients’ assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents “no symptoms” and 10 “disabled, unable to use affected limbs”."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in assessment||95% Confidence Interval|Mean
1229775|NCT00666263|Secondary|Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)|The VAS measured patients’ assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents “no symptoms” and 10 “disabled, unable to use affected limbs”.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
1229776|NCT00666263|Secondary|Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in time||95% Confidence Interval|Mean
1229777|NCT00666263|Secondary|Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Seconds||Inter-Quartile Range|Median
1229797|NCT00666211|Primary|Pain-related Distress|Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8. Pain-related distress scale is from 0 (no pain) to 10 (worst pain).|Baseline(Week 0) to week 8, Total time frame is 9 weeks.||||units on a scale||Standard Deviation|Mean
1229820|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229778|NCT00666263|Secondary|Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in time||95% Confidence Interval|Mean
1229779|NCT00666263|Secondary|Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Seconds||Inter-Quartile Range|Median
1229780|NCT00666263|Secondary|Mean Relative Change in Overall Disability Sum Score|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability (from 0, “no signs of disability” to 12, “most severe disability”). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||percent change in score||95% Confidence Interval|Mean
1229781|NCT00666263|Secondary|Overall Disability Sum Score - Standardized|"The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0–5) + leg disability scale (range 0–7); Overall Range: 0 (no signs of disability) to 12 (maximum disability).~This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
1229782|NCT00666263|Secondary|Overall Disability Sum Score|"The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability.~Overall disability sum score = arm disability scale (range 0–5) + leg disability scale (range 0–7); Overall Range: 0 (no signs of disability) to 12 (maximum disability)."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
1229783|NCT00666263|Secondary|Patient Global Impression of Change|"Patient Global Impression of Change was measured on an ordinal scale of 1-7, higher scores representing greater perceived deterioration since the previous efficacy assessment (ranging from (1) very much improved to very much worse (7)).~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
1229784|NCT00666263|Secondary|Proportion of Participants That Were Accelerated Forward Into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)|Participants were permitted to switch from blinded treatment with placebo or IGIV, 10% to open label IGIV, 10% if they and investigator agreed that deterioration had occurred to the extent that the participant had unacceptable difficulty carrying out daily activities involving the affected muscles, or decline in grip strength of ≥50% in the more affected hand had occurred.|During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Intent to treat|||Proportion of participants|||Number
1229785|NCT00666263|Secondary|Mean Relative Change in Grip Strength in the Less Affected Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - Baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in grip strength||95% Confidence Interval|Mean
1229786|NCT00666263|Secondary|Grip Strength in the Less Affected Hand|"The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg.~Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||kilograms||Inter-Quartile Range|Median
1229818|NCT00665925|Secondary|Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline|The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229787|NCT00666263|Secondary|Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)|"Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percentage of participants|||Number
1229788|NCT00666263|Primary|Mean Relative Change in Grip Strength in the More Affected Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in grip strength||95% Confidence Interval|Mean
1229789|NCT00666263|Primary|Grip Strength in the More Affected Hand|"The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg.~Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||kilograms||Inter-Quartile Range|Median
1229790|NCT00666224|Secondary|Percentage of Participants Who Converted to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. Conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).|up to 3 years|Intent-to-Treat (ITT) analysis set.|||percentage of total participants|||Number
1229791|NCT00666224|Primary|Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. Due to the number of participants in the glatiramer acetate group that converted to CDMS (see outcome #6), the 25th percentile was considered when running the Kaplan-Meier estimate for time to conversion to CDMS. Conversion to CDMS is determined by the occurrence of the second clinical attack.|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.|||days||95% Confidence Interval|Number
1229792|NCT00666224|Secondary|Percentage Change in Brain Volume From Baseline to the Last Observed Value (LOV) During the Double-blind Period Using the Structural Image Evaluation of Normalized Atrophy (SIENA) Technique|Data from interim analysis with database lock on October 14, 2007. Brain volume was measured annually by magnetic resonance imaging (MRI) during the Double-blind period. Brain atrophy was measured by comparing the change in brain volume from baseline to the Last Observed Value (LOV). LOV is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation. SIENA is a fully automated method of analyzing longitudinal brain change.|Day 0 (baseline), up to 3 years|Intent to treat population of participants with both baseline and last observed values.|||percent change||Standard Deviation|Mean
1229793|NCT00666224|Secondary|Change From Baseline to Last Observed Value (LOV) in T2 Brain Lesion Volume in the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. The difference in T2 brain lesion volume as observed in MRIs from baseline to the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.|Day 0 (baseline), up to 3 years|Intent to treat population for which data at both timepoints are available|||ml||Standard Deviation|Mean
1229794|NCT00666224|Secondary|Number of New T2 Brain Lesions Observed at the Last Observed Value (LOV) in the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. T2 lesions are brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. This outcome measures the number of new lesions at the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.|||new T2 lesions||Standard Deviation|Mean
1229795|NCT00666224|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion|Data from interim analysis with database lock on October 14, 2007. The time from randomization to conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.|||days||Standard Deviation|Mean
1229796|NCT00666211|Primary|Pain Duration|Pain duration in hours 0 to 24|at 9 weeks||||hours||Standard Deviation|Mean
1229910|NCT00665626|Secondary|Bilirubin >1.5x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229798|NCT00666211|Secondary|Quality of Life|Each patient in each arm is scored on the Functional Assessment of Cancer Therapy-General (FACT-G) at baseline + week 8 with 4 related sub-scales (physical, social/family, emotional, functional well-being. To generate sub-scale scores, physical and emotional items are reverse coded & items are then summed, such that higher values indicate better quality of life. Thus, each sub-scale score ranges from 0 (not at all, worse outcome) to 4 (very much, better outcome) with a minimum total score of 0 (worst quality of life) to a maximum of 16 (good quality of life).|9 weeks||||scores on a scale||Standard Deviation|Mean
1229799|NCT00666211|Secondary|Mood Disturbance|Patients in each arm will each have 5 measures on the Profile of Mood States-Short Form (POMS-SF): baseline + weeks 2, 4, 6, 8. The POMS-SF consists of 37 questions, querying 6 mood states (anxiety, depression, anger, confusion, fatigue, and vigor), with responses on a scale from 0 (not at all) to 4 (extremely). To generate a summary score, questions on vigor state are first recoded to reverse the scale, so that higher summary scores consistently indicate greater mood disturbance.|9 weeks||||units on a scale||Standard Deviation|Mean
1229800|NCT00666211|Secondary|Interference in Daily Life Due to Pain|Patients in each arm will each have 5 measures on the Brief Pain Inventory (BPI) scale: baseline + weeks 2, 4, 6, 8. The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes). The summary score is the average from the 7 questions, with higher score indicating greater interference due to pain.|9 weeks||||units on a scale||Standard Deviation|Mean
1229801|NCT00666211|Secondary|Ability to Engage in Activities of Daily Living (ADL)|The Functional Assessment Screening Questionnaire (FASQ) scale is used, scored at baseline and at weeks 2, 4, 6, 8. The FASQ consists of 15 questions about ability to perform ADL with minimum score of 1 (easy to perform) to a maximum score of 5 (N/A, meaning someone else performs this activity for the patient or else the patient chooses not to do it). A summary mean score is generated with a minimum score of 1 and a maximum score of 5.|Baseline(Week 0) to week 8, Total time frame is 9 weeks.||||units on a scale||Standard Deviation|Mean
1229802|NCT00666211|Primary|Pain Intensity|"Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8:~Average daily pain intensity 0 (no pain) to 10 (worst) scale~Worst daily pain intensity 0 (no pain) to 10 (worst) scale"|Baseline(Week 0) to week 8, Total time frame is 9 weeks.||||units on a scale||Standard Deviation|Mean
1229803|NCT00666198|Primary|Clinical Efficacy Rate by WHO Functional Classificaton of Severity|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by severity (WHO functional classification of PAH;The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links) were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
1229804|NCT00666198|Primary|Clinical Efficacy Rate by Disease Type|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by disease type were counted to assess whether it contributes to the clinical effectiveness.~* indicates Associated Pulmonary Arterial Hypertension (APAH). ** refers to Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
1229805|NCT00666198|Primary|Clinical Efficacy Rate by Gender|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
1229806|NCT00666198|Primary|Clinical Efficacy Rate by Age|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as “effective,” “ineffective” or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
1229807|NCT00666198|Primary|Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by severity (WHO functional classification for PAH range;This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH) to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Participants|||Number
1229808|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events by Disease Type|"A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by disease type to assess whether it was risk factor for the treatment related adverse events.~* indicates Associated Pulmonary Arterial Hypertension (APAH). ** refers to Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis."|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Participants|||Number
1229809|NCT00666198|Primary|Number of Paritcipants With Treatment-Related Adverse Events by Gender|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Paritcipants|||Number
1229810|NCT00666198|Primary|Number of Paritcipants With Treatment-Related Adverse Events by Age|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Paritcipants|||Number
1229811|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sildenafil citrate was assessed by the physician/investigator.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Participants|||Number
1229812|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sildenafil citrate was assessed by the physician/investigator.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Participants|||Number
1229813|NCT00666029|Primary|Insulin Sensitivity Index|Insulin sensitivity index was assessed during the final steady state 30 minutes of a high dose hyperinsulinaemic euglycaemic clamp (insulin infusion rate 1.5 mIU/kg/min). During this part of the clamp, insulin was infused at 1.5mIU/kg/min and the glucose concentration was maintained at 5 mmol/L using a dextrose infusion. The whole body insulin mediated glucose disposal rate (M value - mg/kg/min) was estimated from the total amount of glucose infused during the last 30 minutes of the clamp. The mean of four serum insulin concentrations was taken during this 30 minutes to determine the steady state insulin concentration (I value - milliunits/litre). M value/I value defined the insulin sensitivity index.|6 months|There was missing data in four people in the atorvastatin arm and two people in the placebo arm|||mg*kg^-1*min^-1*mIU^-1*L^-1||Standard Deviation|Mean
1229814|NCT00666029|Primary|Muscle Microvascular Function|Skeletal muscle microvascular function assessed (Filtrass plethysmographic system) using a passive inductive transducer (Compumedics.dwl, Singen, Germany) and a small pressure step venous congestion protocol. Fluid filtration rate (Jv mL min-1 100 mL-1), measured from the slope of limb volume change in response to each pressure step (10 mmHg steps to 60 mmHg around the thigh) over the last 2 minutes of its application, to allow for completion of vascular filling, and plotted against cuff pressure (Pcuff). The slope of this relationship, at pressures above those giving rise to net filtration, is a measure of Kf, microvascular filtration capacity, a function of exchange surface area and permeability. The CV for Kf measurement was 14.5%.|6 months|There was missing data on two participants in the atorvastatin arm and two participants in the placebo arm.|||10^3 mL*min^-1*100ml^-1*mmHg^-1||Standard Deviation|Mean
1229815|NCT00665925|Secondary|Absolute Neutrophil Count (ANC) <1500/mm3|The number of participants with ANC (a test of liver function) values lower than 1500/mm3|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229816|NCT00665925|Secondary|Bilirubin >2 x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229817|NCT00665925|Secondary|Bilirubin >1.5 x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229821|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229822|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229823|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229824|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5-2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229825|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229826|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229827|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229828|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229829|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229830|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229831|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229832|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229833|NCT00665925|Secondary|Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months|Change from baseline in the MCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The MCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in MCS after treatment|Baseline to 6 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229834|NCT00665925|Secondary|Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months|Change from baseline in the PCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The PCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in PCS after treatment|Baseline to 6 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229835|NCT00665925|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months|Change from baseline in FACIT-F, which is a patient-reported 13-item questionnaire that assesses fatigue, calculated as the score at 6 months minus the score at baseline. The FACIT-F runs from 0 to 52 with lower scores indicating higher fatigue. A positive change from baseline indicates an improvement in fatigue after treatment.|Baseline to 6 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229836|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|6 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229837|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|5 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229838|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|4 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229839|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229840|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|2 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229841|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|1 month|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229842|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|6 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229843|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|5 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229844|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|4 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229845|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229846|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|2 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229847|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|1 month|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229848|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|6 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229849|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|5 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229850|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|4 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229866|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 1 Month|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 month of treatment|1 month|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229851|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229852|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|2 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229853|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|1 month|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229854|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|6 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229855|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|5 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229856|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|4 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229857|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229858|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|2 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229859|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|1 month|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
1229860|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 6 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 months of treatment|6 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229861|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 5 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 5 months of treatment|5 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229862|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 4 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 4 months of treatment|4 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229863|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 3 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment|3 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229864|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 2 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 months of treatment|2 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229865|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 weeks of treatment|6 weeks|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229867|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 weeks of treatment|2 weeks|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229868|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 1 Week|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 week of treatment|1 week|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
1229869|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 6 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229870|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 5 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229871|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 4 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229872|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 3 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229873|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 2 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229874|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 6 Weeks|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229875|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 1 Month|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229876|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 2 Weeks|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229877|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 1 Week|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229878|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 6 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229879|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 5 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229880|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 4 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229906|NCT00665704|Primary|Self Reported 30 Day Smoking Quit Rate|Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.|30 days post intervention||||participants|||Number
1229881|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 3 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229882|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 2 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229883|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 6 Weeks|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229884|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 1 Month|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229885|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 2 Weeks|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229886|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 1 Week|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229887|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 5 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229888|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 4 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229889|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 3 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229890|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 2 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229891|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 6 Weeks|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229892|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 1 Month|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229893|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 2 Weeks|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229907|NCT00665652|Primary|Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide.|"Minimum value of the Total Neuropathy Score is 0, maximum value is 40. A higher score represents a worsening."|Baseline, 12 months|Subjects were evaluable if they were on study drug for 3 months.|||units on a scale||Full Range|Mean
1229894|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 1 Week|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.|||Participants|||Number
1229895|NCT00665925|Primary|American College of Rheumatology 20 (ACR20) Response at 6 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population includes all subjects that received study drug|||Participants|||Number
1229896|NCT00665847|Secondary|The Emergence of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations (NNRTI RAMs) in Patients Classified as Virologic Failures|Virologic failure (lack of response) was defined as: plasma viral load decline of < 0.5 log10 from Baseline by Week 8 and/or plasma viral load decline of <1.0 log10 from Baseline by Week 12. Virologic failure (loss of response) was defined as 2 consecutive measurements of plasma viral load > 0.5 log10 above the nadir after a minimum of 12 weeks of treatment. The table below provides data for 41 viologic failures of which 30 had mutation data available. In the table below, only the 4 most frequently emerging mutations are presented (emerging in at least 3 patients).|Baseline and Endpoint (up to Week 48)|The patients in the intent-to-treat (ITT) population classified as virologic failures were used for this analysis.|||Patients|||Number
1229897|NCT00665847|Secondary|The Change From Baseline in CD4 Cell Counts Over Time||Baseline, Week 48|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.|||10E6 cells/L||Standard Error|Mean
1229898|NCT00665847|Secondary|Change From Baseline in Human Immunodeficiency Virus – Type 1 (HIV-1) Ribonucleic Acid (RNA) in Plasma Over Time||Baseline, Week 48|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.|||log10 copies/mL||Standard Error|Mean
1229899|NCT00665847|Secondary|Percentage of Patients With Virologic Response at Week 24|Virologic response was defined as the percentage of patients with plasma viral load < 50 copies/mL at Week 24 calculated according to the non-completer=failure (NC=F) imputation method.|Week 24|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.|||Percentage of Patients|||Number
1229900|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Maximum Plasma Concentration (Cmax)|Etravirine/TMC125 (ETR) Cmax was approximated for each individual using the median value of plasma ETR concentrations taken 4 hours postdose (± 1 hour), when available, on the day of the Week 4 visit as shown in the table below.|Week 4|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.|||ng/mL||Standard Deviation|Mean
1229901|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Trough Plasma Concentration (C0h)||Week 48|"The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken ETR at least once, regardless of their compliance with the protocol was used for this analysis. The table below shows results for Overall (children and adolescents combined)."|||ng/mL||Standard Deviation|Mean
1229902|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Area Under the Plasma Concentration-time Curve Over 12 Hours at Steady-state (AUC12h)|The AUC12h is a Bayesian estimation based on a population pharmacokinetic model and sparse samples collected at each visit over the duration of trial. For each sparse sample taken, the time blood sample was recorded as well as the time of etravirine intake just prior to the time of blood sample.|Weeks 4-48|"The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken ETR at least once, regardless of their compliance with the protocol was used for this analysis. The table below shows results for Overall (children and adolescents combined)."|||ng.h/mL||Standard Deviation|Mean
1229903|NCT00665847|Primary|The Percentage of Patients With Treatment-emergent Adverse Events (TEAEs)|The percentage of patients with a treatment-emergent adverse event (TEAE) (defined as an event that occurred in the 48-week treatment period during which it emerged [i.e. started or worsened in severity, relation, or other attribute], and not in the subsequent study periods, even if the event continued to be present] are provided below. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen|48 weeks|The safety analysis was done on the intent-to-treat (ITT) population, which included all patients who received at least one dose of investigational medication.|||Percentage of patients|||Number
1229904|NCT00665847|Primary|The Number of Patients With Treatment-emergent Adverse Events (TEAEs)|A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 48-week treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and not in the subsequent study periods, even if the event continued to be present. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen|48 weeks|The safety analysis was done on the intent-to-treat (ITT) population, which included all patients who received at least one dose of investigational medication.|||Patients|||Number
1229905|NCT00665704|Secondary|Patient Feedback to Evaluate the Website|Formative evaluation during pre-testing included qualitative feedback on the: 1) ability to accomplish tasks; 2) ability to accomplish goals with skill and speed; 3) ability to operate the system; and 4) satisfaction. For the 9 veteran smokers that actually tried to use the Tobacco Tactics website to quit smoking, we were able to determine: 1) the number of times they signed onto the website; 2) the time spent on the website; and 3) the number of times each module was accessed.|30 days post intervention||||participants|||Number
1235157|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 6, ITT Population.||Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1229911|NCT00665626|Secondary|Alkaline Phosphatase >1.5x Upper Limit of Normal (ULN) and >1.5x Baseline|The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229912|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >10x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229913|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >5-10x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229914|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229915|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229916|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229917|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229918|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229919|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229920|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229921|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229922|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229923|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229924|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229925|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
1229926|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Synovitis Score at 3 Months|Change from baseline in RAMRIS synovitis score (a measure of inflammation in the joints of the hands and wrists), calculated as the score at 3 months minus the score at baseline. The synovitis score runs from 0 to 24 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.|||Score||Standard Deviation|Mean
1229927|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Osteitis Score at 3 Months|Change from baseline in RAMRIS osteitis score (a measure of bone inflammation in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The osteitis score runs from 0 to 75 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.|||Score||Standard Deviation|Mean
1229928|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Erosion Score at 3 Months|Change from baseline in RAMRIS erosion score (a measure of bone erosion in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The erosion score runs from 0 to 250 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.|||Score||Standard Deviation|Mean
1229929|NCT00665626|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 2|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 2 weeks|2 weeks|Intent-to-treat population|||Participants|||Number
1235158|NCT00619957|Secondary|Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.||Baseline to Month 3|ITT Population|||percent||95% Confidence Interval|Least Squares Mean
1229930|NCT00665626|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 1|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 1 week.|1 week|Intent-to-treat population|||Participants|||Number
1229931|NCT00665626|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant|||Participants|||Number
1229932|NCT00665626|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant|||Participants|||Number
1229933|NCT00665626|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant|||Participants|||Number
1229934|NCT00665626|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant|||Participants|||Number
1229935|NCT00665626|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 3 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment|3 months|Intent-to-treat population|||Score||Standard Deviation|Mean
1229936|NCT00665626|Secondary|American College of Rheumatology 70 (ACR70) Response at 3 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months|3 months|Intent-to-treat population|||Participants|||Number
1229937|NCT00665626|Secondary|American College of Rheumatology 50 (ACR50) Response at 3 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months|3 months|Intent-to-treat population|||Participants|||Number
1229938|NCT00665626|Primary|American College of Rheumatology 20 (ACR20) Response at 3 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months|3 months|Intent-to-treat population|||Participants|||Number
1229939|NCT00665470|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V3.0|Here is the number of participants with adverse events. For a detailed list of participants with adverse events, see the adverse event module.|16 months||||Participants|||Number
1229940|NCT00665470|Primary|Response|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|30 months||||Participants|||Number
1229941|NCT00665457|Primary|Participants Who Experienced Pathologic Complete Response, Progression-free and Overall Survival, and Time to Treatment Failure|CTEP RECIST guidelines are defined as followed: Pathologic complete response is no signs of residual malignancy cells at the primary site and axillary lymph nodes are seen with histologic examination. Progression-free survival is defined as from the first date of therapy until the first notation of clinical progression or relapse. Overall survival is defined as from the first date of therapy until the date of death. Time to treatment failure is defined as from the first date of therapy until the date the patient is removed from study for any reason.|20 weeks||||Participants|||Count of Participants
1229942|NCT00665457|Primary|Number of Participants With Grade 4 Adverse Events|Grading of adverse events was determine by the principal investigator according to NCI common toxicity criteria (CTC version 3.0). Safety analysis is based on any participant experiencing a grade 4 AE.|every 3 weeks X 4, then every 2 weeks X4|Of the 3 participants, one had a grade 4 event - neutropenic fever.|||Participants|||Count of Participants
1229943|NCT00665444|Secondary|Hamilton Rating Scale for Depression||3 months|Study was terminated early and data were not collected for this outcome.||||||
1229944|NCT00665444|Secondary|Young Mania Rating Scale||3 months|Study was terminated early and data were not collected for this outcome.||||||
1229945|NCT00665444|Secondary|Quality of Life Enjoyment Questionnaire||3 months|Study was terminated early and data were not collected for this outcome.||||||
1229946|NCT00665444|Secondary|Global Assessment of Functioning||3 months|Study was terminated early and data were not collected for this outcome.||||||
1229947|NCT00665444|Primary|Epworth Sleepiness Scale (General Level of Daytime Sleepiness)||3 month|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.||||||
1229948|NCT00665444|Primary|BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),||3 months|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.||||||
1229949|NCT00665431|Secondary|The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event|The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population|||participants|||Number
1229950|NCT00665431|Secondary|Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms|Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population|||participants|||Number
1229951|NCT00665431|Secondary|Percent of Days With no Heartburn (Heartburn Resolution)|During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).|12 weeks|Intent to treat|||percent days||Standard Deviation|Mean
1229952|NCT00665431|Secondary|Modified Severity of Dyspepsia Assessment (mSODA)|Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.|12 weeks|intent to treat with last observation carried forward|||Scores on a scale||Standard Deviation|Mean
1229953|NCT00665431|Secondary|Antacid Tablet Use|Tablet pill count|12 weeks|Intent to treat|||Tablets per subject||Standard Deviation|Mean
1229954|NCT00665431|Secondary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|Week 6|Intent to treat|||mm||Standard Deviation|Mean
1229955|NCT00665431|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat|||mm||Standard Deviation|Mean
1229956|NCT00665431|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat|||mm||Standard Deviation|Mean
1229957|NCT00665431|Secondary|Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.|For APS-POQ score is the change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.|Baseline and Day 7|Intent to treat|||Units on a scale||Standard Deviation|Mean
1229958|NCT00665431|Primary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
1229959|NCT00665431|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
1229960|NCT00665431|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Baseline and 12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
1229961|NCT00665366|Secondary|Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)|BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.|||kg/m^2||Full Range|Median
1229962|NCT00665366|Secondary|Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)|Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.|||Percentage of participants|||Number
1229963|NCT00665366|Secondary|Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)|Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.|||Kilograms||Standard Error|Mean
1229964|NCT00665366|Secondary|Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)|Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
1229965|NCT00665366|Secondary|Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)|Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.|Baseline to Weeks 6 and 12|All randomized participants who received at least 1 dose of study medication and had at least 1 outcome research evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
1229966|NCT00665366|Secondary|Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)|Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.|Baseline to Weeks 3,6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Percentage of participants|||Number
1229967|NCT00665366|Secondary|Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)|Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Percentage of participants|||Number
1229968|NCT00665366|Secondary|Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)|The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
1229969|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)|Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
1230020|NCT00664430|Secondary|Number of Participants With Adverse Events|The occurrence of adverse events was considered a secondary endpoint in this study. For details on adverse events that occurred prior to study termination, refer to the safety section below.|Up to 1 year||||Participants|||Number
1229970|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)|Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
1229971|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)|Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
1229972|NCT00665366|Primary|Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)|The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug.|||Units on a scale||Standard Error|Mean
1229973|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 fasting lipid results.|||mg/dL||Inter-Quartile Range|Median
1229974|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 HOMA-IR results.|||mg/dL x uIU/mL / 405||Inter-Quartile Range|Median
1229975|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 LFT results.|||x ULN||Inter-Quartile Range|Median
1229976|NCT00665353|Secondary|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.||Week 72 of Step 2|All enrolled subjects.|||proportion of participants||90% Confidence Interval|Number
1229977|NCT00665353|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.|Step 2 (Up to 72 weeks)|All subject enrolled in Step 2.|||participants|||Number
1229978|NCT00665353|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.|Step 1 (Up to 24 to 28 weeks)|All enrolled subjects.|||participants|||Number
1229979|NCT00665353|Primary|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.||Week 24 of Step 2|All enrolled subjects.|||proportion of participants||90% Confidence Interval|Number
1229980|NCT00665132|Secondary|Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5|Using Brief Pain Inventory questions 14 and 15, those 9 subjects who had pain change from Baseline to Day 5 were analyzed to determine change in pain for the overall group. In the BPI, an 11-point NRS is used to rate pain intensity, with a 0 for ‘‘no pain’’ and a 10 for ‘‘pain as bad as you can imagine.’’ At Baseline, patients circled the number that best described how much baseline pain they had 'on average' (BPI #14). During the study, patients circled the one number that best described how much pain they had at the time 'right now' (BPI #15).|Day 5 after final stimulation|Nine subjects who reported change after 5 days of StimRouter System use are analyzed to determine mean change in pain from Baseline to Day 5 of Stimulation for the overall group.|||units on a scale||Standard Deviation|Mean
1229981|NCT00665132|Secondary|Percent of Participants Reporting Pain Change From Baseline to Day 5|Brief Pain Inventory (BPI) questions 14 and 15 were used to measure pain change after 5 days use of StimRouter System. In the BPI, an 11-point numerical rating scale (NRS) is used to rate pain intensity, where zero (0) indicates ‘‘no pain’’ and 10 indicates ‘‘pain as bad as you can imagine.’’ At enrollment, participants circled the number that best described how much baseline pain they had 'on average' (BPI #14). After enrollment and during the study, patients circled the one number that best described how much pain they had at that time 'right now' (BPI #15). The percent of participants with change from Baseline to Day 5 was calculated.|Day 5|All ten participants were analyzed.|||percentage of patients|||Number
1229982|NCT00665132|Secondary|Patent Satisfaction|Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied|Day 5 after final stimulation|All ten subjects responses were analyzed.|||units on a scale||Standard Deviation|Mean
1229983|NCT00665132|Primary|Implant Success|Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed.|at device implantation procedure||||participants with successful implant|||Number
1229984|NCT00665002|Secondary|Participants Whose Samples Demonstrated Immunological Response After Vaccination|"Immune Response: Immune reactivity was measured for all participants. Immune response was measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT and/or multiparameter intracellular staining by flow cytometry were performed as well.~ELISPOT Assay: CD4+ immune response, CD4+ and CD8+ response. The samples of participants' blood obtained at baseline and week 12 were tested for CD4 T cell proliferation, CD4 and CD8 T cell interferon release.~Tetramer Analysis of WT1-specific Immune responses: subtle WT1 T cell expansion, positive by ELISPOT and T cell expansion.~Delayed-type Hypersensitivity (DTH): measurable DTH response without overlap with ELISPOT or tetramer responders).~Overall: any form of immune response."|12 weeks|All participants|||participants|||Number
1229985|NCT00665002|Primary|Number of Participants With Adverse Events (AEs)|Toxicities were tabulated according to the NCI Common Toxicity (version 3.0) by grade and category. If more than one patient developed ≥ grade 3 non-hematologic toxicity or grade 4 hematologic toxicity, the study accrual was to be suspended immediately for a careful toxicity data evaluation. Depending upon the findings of such safety/toxicity data assessment and consultation with the supporting pharmaceutical company, the principal investigator of this trial would have the option of terminating this trial permanently, amending the study protocol, or resuming the patient accrual.|12 weeks to 6 months|All participants|||participants|||Number
1229986|NCT00664755|Primary|End-of-treatment Abstinence|Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment|2 weeks||||Participants|||Count of Participants
1229987|NCT00664742|Secondary|Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels|The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC <200 mg/dL, LDL-C <100 mg/dL, HDL-C >=60 mg/dL and TG < 150 mg/dL.|Baseline, 6 weeks|This analysis was done on the safety population which consists of all participants who received at least one dose of study medication.|||Percentage of Participants|||Number
1229988|NCT00664742|Primary|Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6|Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.|Baseline,6 weeks|The analysis was done on the Per Protocol Population which consists of all participants who did not violate inclusion/ exclusion criteria, completed the treatment study phase or withdrew from the study due to progression, death, or toxicity (AE related to study drug) and had at least one key response evaluation.|||mg/dL||95% Confidence Interval|Mean
1229989|NCT00664560|Secondary|The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event|The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population|||participants|||Number
1229990|NCT00664560|Secondary|Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms|Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population|||participants|||Number
1229991|NCT00664560|Secondary|Percent of Days With no Heartburn (Heartburn Resolution)|During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).|12 weeks|Intent to treat|||percent days||Standard Deviation|Mean
1229992|NCT00664560|Secondary|Modified Severity of Dyspepsia Assessment (mSODA)|Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
1229993|NCT00664560|Secondary|Antacid Tablet Use|Tablet pill count|12 weeks||||Tablets per subject||Standard Deviation|Mean
1229994|NCT00664560|Secondary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|Week 6|Intent to treat|||mm||Standard Deviation|Mean
1229995|NCT00664560|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat|||mm||Standard Deviation|Mean
1229996|NCT00664560|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat|||mm||Standard Deviation|Mean
1229997|NCT00664560|Secondary|American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.|Mean change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.|Baseline and Day 7|Intent to Treat|||Units on a scale||Standard Deviation|Mean
1229998|NCT00664560|Primary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
1229999|NCT00664560|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
1230000|NCT00664560|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Baseline and 12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
1230001|NCT00664534|Secondary|Number of Participants With Adverse Events|"A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.~TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline."|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period.|||participants|||Number
1230002|NCT00664534|Secondary|Rate Per 30 Days of All Self-reported Hypoglycemic Episodes|The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.|||episodes per 30 days||Standard Deviation|Mean
1230003|NCT00664534|Secondary|Incidence of All Self-reported Hypoglycemic Episodes|Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.|||percentage of participants|||Number
1230004|NCT00664534|Secondary|Body Weight Change From Baseline to Endpoint||baseline, 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
1230005|NCT00664534|Secondary|Mean Daily Total, Basal and Prandial Insulin Dose||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||International Units per day (IU/day)||Standard Deviation|Mean
1230006|NCT00664534|Secondary|Mean Postprandial Blood Glucose Values|Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.|Baseline, 16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||microgram per milliliter (µg/mL)||Standard Deviation|Mean
1230007|NCT00664534|Secondary|7-point Self-monitored Blood Glucose Profiles||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
1230008|NCT00664534|Secondary|Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||percentage of participants|||Number
1230009|NCT00664534|Secondary|HbA1c Over Time|Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit*treatment in Full Analysis Set (FAS) Population.|16 weeks, 32 weeks, and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||percent glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1232301|NCT00642759|Secondary|Objective Response Rate to Carboplatin, Abraxane and Avastin|Objective response rate to carboplatin, Abraxane and Avastin according to Response Evaluation Criteria in Solid Tumors [Version 1.0]|3 years||||Participants|||Count of Participants
1230010|NCT00664534|Secondary|Percentage of Participants Using Each Possible Final Insulin Regimen|"Insulin Regimens:~Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro."|48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had a measurement for the dependent variable at the time point, according to intent-to-treat (ITT) principles.|||percentage of participants|||Number
1230011|NCT00664534|Primary|Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint|Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.|48 weeks|"PP Population=All participants who were randomized and met following criteria during study:~no violations of Inclusion/Exclusion Criteria~no early study discontinuation~compliant with treatment~received no other antihyperglycemic medication than allowed in Protocol, and have not been on systemic glucocorticoids for >14 consecutive days."|||percent glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1230012|NCT00664521|Secondary|Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells|Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels.|Baseline, Week 3, 7, 12, 16, 26 and 32|Safety population included all participants who received at least one dose of atacicept or placebo. Here 'n' signifies those participants who were evaluable for the specified category.|||percent change||Inter-Quartile Range|Median
1230013|NCT00664521|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 score ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Baseline, Week 32|ITT population included all randomized participants. Here 'n' signifies those participants who were evaluable for the specified category.|||Units on a scale||Standard Deviation|Mean
1230014|NCT00664521|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32|ACR20-CRP response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). ACR50-CRP and ACR70-CRP response are defined as >=50% and >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) respectively together with >=50% and >=70% improvement in at least 3 of the following respectively: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) CRP.|Week 32|ITT population included all randomized participants.|||percentage of participants|||Number
1230015|NCT00664521|Primary|Percent Change From Baseline in Anti-pneumococcus Titer at Week 32|Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||percent change||Inter-Quartile Range|Median
1230016|NCT00664521|Primary|Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32|Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here. N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||percent change||Inter-Quartile Range|Median
1230017|NCT00664521|Primary|Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32|Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature. Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen. Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category."|||Percent change||Standard Deviation|Mean
1230018|NCT00664521|Primary|Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L)||Week 64|Safety population included all participants who received at least one dose of atacicept or placebo. Here. “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1230019|NCT00664521|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 64|Safety population included all participants who received at least one dose of atacicept or placebo.|||Participants|||Number
1230021|NCT00664430|Secondary|Changes in Bone Remodeling Markers Over Time|Deoxypyridinoline and bone-specific alkaline phosphatase levels were to be measured every 3 months and changes over time analyzed using descriptive statistics.|Every 3 months|No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the secondary analysis.|||ng/mL||Standard Deviation|Mean
1230022|NCT00664430|Primary|Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values|This outcome was measured at Visit 15, which could occur at different timepoints from study start, depending on the duration of each study period for each participant, relative to values on Visit 4. For participants who did not perform visit 4, the reduction of the PTH levels were to be assessed relative to visit 5 values.|Up to Week 24|No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the primary analysis.|||Proportion of participants|||Number
1230023|NCT00664326|Other Pre-specified|Duration of Stable Disease (Update)|Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.|||Days||95% Confidence Interval|Median
1230024|NCT00664326|Other Pre-specified|Duration of Response (Update)|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Only subjects from ITT population with a response of CR or PR were included in this evaluation.|||Days||95% Confidence Interval|Median
1230025|NCT00664326|Other Pre-specified|Time to Progression (Update)|TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
1230026|NCT00664326|Other Pre-specified|Progression-free Survival (Update)|PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
1230027|NCT00664326|Other Pre-specified|Overall Survival (Update)|Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
1230028|NCT00664326|Other Pre-specified|Disease Control (Update)|Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
1230029|NCT00664326|Other Pre-specified|Tumor Response (Update)|Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
1230030|NCT00664326|Other Pre-specified|Objective Tumor Response (Update)|Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
1230031|NCT00664326|Secondary|Duration of Stable Disease (SD)|Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.|||Days||95% Confidence Interval|Median
1230032|NCT00664326|Secondary|Duration of Response|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Only subjects from ITT population with a response of CR or PR were included in this evaluation.|||Days||95% Confidence Interval|Median
1230033|NCT00664326|Secondary|Time to Progression (TTP)|TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
1230034|NCT00664326|Secondary|Progression-free Survival (PFS)|PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
1230035|NCT00664326|Secondary|Overall Survival|Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
1230036|NCT00664326|Secondary|Disease Control|Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
1230037|NCT00664326|Primary|Tumor Response|Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
1230038|NCT00664326|Primary|Objective Tumor Response|Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
1230039|NCT00664209|Secondary|Participants With Side Effects From Study Treatment|Side effects profile|2 months|All subjects receiving H. pylori treatment|||participants|||Number
1230040|NCT00664209|Secondary|Improvement in Quality of Life as Assessed by PDQ-39|The Parkinson's Disease Questionnaire (PDQ)-39 contains 39 questions addressing how often patients have experienced difficulties due to having PD in the preceding month. Items are scored from 0 (never) to 4 (always). Lower scores indicate better quality of life.|2 months|Subjects H pylori positive with greater than 4 hrs off time/day and completing the PDQ-29||||||
1230041|NCT00664209|Secondary|Improvement in UDPRS Part III|"Improvement in UDPRS Part III (Motor) scores (on and off) UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement"|2 months|Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS||||||
1230042|NCT00664209|Secondary|Improvement in UPDRS Total Scores|The Unified Parkinson Disease Rating Scale (UPDRS) is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.|2 months|Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS||||||
1230043|NCT00664209|Primary|"Off Time"|"Average total daily off time (measured by patient symptom diaries) in hours"|2 months|Participants did not return symptom diaries||||||
1230044|NCT00664105|Secondary|Number of Participants With Adverse Events by Grade|Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event|30 days after last treatment.|Patients who received treatment and who experienced an adverse event.|||participants|||Number
1230045|NCT00664105|Secondary|Time to Disease Progression|Time to disease progression in months|on-study date to date of progression|Patients with disease progression.|||Months||Full Range|Median
1232940|NCT00637728|Secondary|Change in Weight Over the Course of the 8-week Double-blind Phase||Baseline, Week 1, 2, 3, 4, 6, and 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.||||||
1230046|NCT00664105|Secondary|Overall Response Rate|"Patient response to treatment per RECIST:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|on-study date to date of best response|Patients who were available for measurement of response. Six patients were not available for measurement of response and are not included in the analyzed population|||participants|||Number
1230047|NCT00664105|Primary|Overall Survival|Months from on-study to expired/last date known alive.|14.95 months (average duration, on study date to off-study date)|Patients who received at least one treatment and who were available for determination of overall survival.|||Months||Full Range|Median
1230048|NCT00664066|Primary|Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|up to 3 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|||Participants|||Number
1230049|NCT00663962|Primary|Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively|Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale)|2 months postoperatively|pilot study--convenience|||participants|||Number
1230050|NCT00663962|Primary|The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.||2, 4, and 6 months|||||||
1230051|NCT00663923|Secondary|Surgically Induced Astigmatism|"It is the vector of the astigmatic change actually induced by the surgery.Participant population was the same as baseline participants.~It was measured by refraction(using autorefractor) and vector analysis(using special software).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters"|six months after surgery||||Diopter||Standard Deviation|Mean
1230052|NCT00663923|Secondary|Uncorrected Distance Visual Acuity (UCDVA)|UCDVA is attained without correction of refractive errors .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart( the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations.|six months|the analysis was per protocol|||LogMAR|Participants|Standard Deviation|Mean
1230053|NCT00663923|Secondary|Corrected Distance Visual Acuity(CDVA)|CDVA is attained after correction of refractive errors using lenses of varying powers .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart(the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations.|six months|the analysis was per protocol|||LogMAR|Participants|Standard Deviation|Mean
1230054|NCT00663923|Secondary|Higher Order Aberrations|Although lower- order aberrations decrease after laser vision correction,higher -order aberrations may increase after conventional PRK or LASIK(Laser in situ keratomileusis).Higher-order aberration is Composed of delicate irregularities within the cornea not correctable by spectacles.It is measured using aberrometer.In this study OPD scan was used that is one of the methods of wavefront analysis .|six months postoperative|the analysis was per protocol.|||micron|Participants|Standard Deviation|Mean
1230055|NCT00663923|Primary|Correction of Astigmatism|It shows the result of correction of astigmatism .In compound myopic astigmatism the meridians of maximum and minimum power are both too strong.So both line images fall short of the retina.It is measured by refraction(using autorefractor).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters.|six months after surgery|"The sample size was determined by the one proportion formula where power = 0.8, d=0.02 , p= 0.5(primary outcome) and type I error probability associated with this test of null hypothesis is 0.05.~The analysis was per protocol"|||diopter|Participants|Standard Deviation|Mean
1230056|NCT00663858|Primary|International Prostate Symptom Score (IPSS)|IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)|Baseline and 52 weeks||||Units on a scale||Standard Deviation|Mean
1230057|NCT00663819|Secondary|Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.|Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.|Within 4 - 12 weeks post-surgery|"Significant Post Operative Complications"|||Participants|||Count of Participants
1230058|NCT00663819|Secondary|Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses||Post operative||||Participants|||Count of Participants
1230059|NCT00663819|Secondary|Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.||Post operative||||Participants|||Count of Participants
1230060|NCT00663819|Primary|Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak|The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.|Completion of procedure through 4-12 weeks post procedure||||Participants|||Count of Participants
1230061|NCT00663793|Secondary|Area Under the Curve-E2||14 Days||||nmol*h/L||Standard Deviation|Mean
1230062|NCT00663793|Secondary|Area Under the Curve-serum DHT||14-days||||nmol*h/L||Standard Error|Mean
1230063|NCT00663793|Primary|Area Under the Curve-Serum T||14 days||||nmol*h/L||Standard Error|Mean
1230064|NCT00663702|Primary|Mean Temperature|Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable|||Degrees Celsius||Standard Deviation|Mean
1230065|NCT00663702|Primary|Mean Heart Rate|Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable|||Beats per minute||Standard Deviation|Mean
1230066|NCT00663702|Primary|Mean Sitting Systolic and Diastolic Blood Pressure (BP)|BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable|||mm Hg||Standard Deviation|Mean
1230067|NCT00663702|Primary|Number of Participants With Adverse Events of Special Interest|AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).|Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1230068|NCT00663702|Primary|Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality|preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use >=2 or, if value >= 4, or if preRx=0 or 0.5, use >=2 or, if preRx= 1, use >=3 or, if preRx=2 or 3, use >=4.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
1230069|NCT00663702|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time|The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.|Day 1 (Baseline) to Day 1093|All participants who received at least 1 dose of study medication|||Units on a scale||Standard Deviation|Mean
1230070|NCT00663702|Secondary|Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:|LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP <2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Day 1 (Baseline) through Day 1093|All participants who received at least 1 dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1230071|NCT00663702|Secondary|Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time|The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Day 1 (Baseline) through Day 1093|All participants who received at least 1 dose of study medication|||Units on a scale||Standard Deviation|Mean
1230072|NCT00663702|Secondary|Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85|"Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers >10) included:~A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline~A negative baseline immunogenicity response and a positive immunogenicity response postbaseline~A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value"|Day 1 (Baseline) through Day 85|All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable|||Percentage of participants|||Number
1230073|NCT00663702|Secondary|Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85|Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.|Day 1 (Baseline) through Day 85|All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable|||Percentage of participants|||Number
1230074|NCT00663702|Primary|Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .|Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
1230075|NCT00663702|Primary|Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: <0.95*LLN or >1.05*ULN or if preRx<LLN, <0.95*preRx or >ULN, or if preRx>ULN,>1.05*preRx or <LLN. Potassium,serum: <0.9*LLN or >1.1*ULN or if preRx<LLN, use <0.9*preRx or >ULN or if preRx>ULN, 1.1*preRx or <LLN. Phosphorus: 0.75*LLN or 1.25*ULN or, if preRx<LLN, <0.67*preRx or >ULN or, if preRx>ULN, <LLN.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
1230076|NCT00663702|Primary|Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2*ULN or if preRx>ULN, use 3*preRx. Alanine aminotransferase (U/L)>3*ULN or if preRx>ULN, use >4*preRx. G-glutamyl transferase (U/L)>2*ULN or if preRx>ULN, use >3*preRx. Blood urea nitrogen (mg/dL)>2*preRx. Creatinine (mg/dL)>1.5*preRx.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
1230077|NCT00663702|Primary|Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75*preRx. Erythrocytes (*10^6 c/uL) <0.75*preRx. Platelet count (*10^9 c/L) <0.67*LLN or 1.5*ULN or, if preRx<LLN, use <0.5*preRx and <100,000 mm^3. Leukocytes (*10^3 c/uL) <0.75*LLN or >1.25*ULN or, if preRx<LLN, use <0.8*preRx or >ULN or, if preRx>ULN, use >1.2*preRx or <LLN. Eosinophils >0.750*10^3 c/uL. Lymphocytes <0.750*10^3 c/uL or >7.50*10^3 c/uL.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
1230078|NCT00663702|Primary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation|An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication|||Participants|||Number
1230079|NCT00663702|Secondary|Mean Trough Serum Concentration (Cmin) of Abatacept|Cmin of abatacept was determined from serum samples.|Days 29, 85, 57, and 85|All participants who received at least 1 dose of study medication. n=patients who had at least 1 pharmacokinetic sample drawn postbaseline|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1230080|NCT00663702|Primary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85|An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.|Day 1 (Baseline) through Day 85|All participants who received at least 1 dose of study medication|||Participants|||Number
1230081|NCT00663403|Secondary|Daptomycin Free Fraction|"In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the free component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria."|From time of daptomycin administration to 48 hours post dose||||percent protein binding||Standard Deviation|Mean
1230082|NCT00663403|Secondary|Daptomycin Half-life|Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis||||hours||Standard Deviation|Mean
1230083|NCT00663403|Secondary|Daptomycin Total Body Clearance|Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis||||mL/min/kg||Standard Deviation|Mean
1230084|NCT00663403|Secondary|Daptomycin Volume of Distribution at Steady State|Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body.|From time of daptomycin administration to 48 hours post dose||||L/kg||Standard Deviation|Mean
1230085|NCT00663403|Secondary|Observed Daptomycin Peak Serum Concentration|The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min.|At the end of the daptomycin intravenous infusion (at approximately 30 minutes)||||ug/mL||Standard Deviation|Mean
1230086|NCT00663403|Secondary|Daptomycin Dose Actually Administered||Time of daptomycin administration||||mg/kg||Standard Deviation|Mean
1230087|NCT00663403|Primary|Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis|Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis||||mL/min||Standard Deviation|Mean
1230102|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.|||percentage of participants||90% Confidence Interval|Number
1230088|NCT00663260|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
1230089|NCT00663260|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1230090|NCT00663260|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
1230091|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
1230092|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
1230093|NCT00663234|Secondary|Percentage of Participants With Undetectable Plasma HIV-1 RNA|Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.|Study entry and weeks 12, 24, and 48|All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week.|||percentage of participants||90% Confidence Interval|Number
1230094|NCT00663234|Secondary|Percent Change in Interleukin 6 (IL-6) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week.|||percentage of IL-6 at study entry||90% Confidence Interval|Median
1230095|NCT00663234|Secondary|Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week.|||percentage of hs-CRP at study entry||90% Confidence Interval|Median
1230096|NCT00663234|Secondary|Percent Change in Apolipoprotein B (Apo B) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week.|||percentage of Apo B at study entry||90% Confidence Interval|Mean
1230097|NCT00663234|Secondary|Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week.|||percentage of Apo A-1 at study entry||90% Confidence Interval|Mean
1230098|NCT00663234|Secondary|Percent Change in HDL-cholesterol (HDL-C) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week.|||percentage of HDL-C at study entry||90% Confidence Interval|Mean
1230099|NCT00663234|Secondary|Percent Change in Triglycerides (TG) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week.|||percentage of TG at study entry||90% Confidence Interval|Mean
1230100|NCT00663234|Secondary|Percent Change in Fasting Total Cholesterol (TC) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week.|||percentage of TC at study entry||90% Confidence Interval|Mean
1230101|NCT00663234|Primary|Percent Change in LDL Cholesterol (LDL-C) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week.|||percentage of LDL-C at study entry||90% Confidence Interval|Mean
1230103|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.|||percentage of participants||90% Confidence Interval|Number
1230104|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
1230105|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who completed the study per protocol (initiated study drug, had LDL-C data available at all required study visits, attended study visits within the protocol-specified window, were dose-escalated according to protocol, and reported adherence to study drug at all study visits).|||percentage of participants||90% Confidence Interval|Number
1230106|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated study treatment and have LDL-C data available at study entry and the specified week.|||percentage of participants||90% Confidence Interval|Number
1230107|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.|||percentage of participants||90% Confidence Interval|Number
1230108|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE)|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
1230109|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
1230110|NCT00663208|Secondary|Number of Participants Meeting Pre-Specified Criteria in Electrocardiogram Parameters|Pre-specified criteria were defined as, Heart rate (HR) minimum as <=50 bpm/change from baseline <-20 bpm/maximum HR >100 bpm, QT interval corrected using Fridericia's formula (QTcF) maximum as QTcF<=450 msec/450 msec <maximum QTcF and <=480 msec/480 msec <maximum QTcF <= 500 msec/maximum QTcF>500 msec, QRS interval as <=120 msec/>120 msec, and PR interval maximum as <= 200 msec/>200 msec.|Screening, Day 2, 3, 5, 7, 9, 11, 13, 15, 21 and 28|All participants treated with study drug were summarized.|||participants|||Number
1230111|NCT00663208|Secondary|Number of Participants With Clinically Relevant Change From Baseline in Vital Signs|Vital signs included: body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. Blood pressure and heart rate were measured after the participant had been supine, semi-supine, or seated quietly for at least 5 minutes. Baseline was defined as the last observation prior to dosing on Day 1.|Screening, Day -1 and prior to morning dose on Day 1, 2, 14, and 28|All participants treated with study drug were summarized.|||participants|||Number
1230112|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Urinalysis|Marked laboratory abnormalities in urinalysis were defined as, Blood Urine High as >= 2*PreRx if PreRx >= 1/>= 2 if PreRx < 1/>= 2 if PreRx = Missing. Glucose Urine High as >= 1 if PreRx < 1/>= 1 if PreRx = Missing/>= 2*PreRx if PreRx >= 1.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.|||participants|||Number
1230113|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Lipase and Glucose|Marked abnormalities were defined as Lipase (U/L) High as >1.5*ULN, Glucose fasting serum (mg/dL) High as > 1.3*ULN if LLN <= PreRx <= ULN/> 1.3*ULN if PreRx = Missing/>2*PreRx; if PreRx > ULN/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.|||participants|||Number
1230114|NCT00663208|Secondary|Number of Participants With Marked Abnormalities in Liver and Kidney Function Laboratory Tests and Electrolytes|Liver and kidney function marked laboratory abnormalities were defined as Alanine Aminotransferase (ALT) units per liter (U/L) High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Aspartate Aminotransferase (AST) U/L High as > 1.25* PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Alkaline Phosphatase(ALP)U/L High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, G-Glutamyl Transferase (GGT) in U/L High as >1.15*ULN if PreRx<=ULN/>1.15* if PreRx missing/>1.2* PreRx if PreRx>ULN, Phosphorus Inorganic (mg/dL) Low as < 0.85*LLN if LLN <= PreRx <= ULN/< 0.85*LLN if PreRx = Missing/< 0.85*PreRx if PreRx < LLN/< LLN if PreRx > ULN, and Potassium serum milliequivalents per liter (mEq/L) High as > 1.1*PreRx if PreRx > ULN/> 1.1*ULN if LLN <= PreRx <= ULN/> 1.1*ULN if PreRx = Missing/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants who were treated with study drug were summarized.|||participants|||Number
1232956|NCT00637416|Primary|Change in Condition Over Treatment Period|Change measured using voice assessment protocol—Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).|3 months|Study was stopped early, data were not collected, and zero participants were analyzed.||||||
1230115|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hematology|Hematology marked laboratory abnormalities were defined as Hemoglobin (g/dL) Low as < 0.85*Pre-therapy (PreRx), Hematocrit (%) Low as < 0.85*PreRx, Platelet Count *10^9 c/L Low as < 0.85*Lower Limits of Normal (LLN) if PreRx = Missing/< 0.85*LLN if PreRx >= LLN/< 0.85*PreRx if PreRx < LLN, Eosinophils (absolute) *10^3 c/µL High as > 0.75*count, Leukocytes White Blood Cell (WBC) *10^3 c/µL High as > 1.2*ULN if LLN <= PreRx <= Upper Limits of Normal (ULN) > 1.2*ULN if PreRx = Missing/> 1.5*PreRx if PreRx > ULN/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.|||participants|||Number
1230116|NCT00663208|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 182 or Day of Discharge|All participants who received study drug were summarized.|||participants|||Number
1230117|NCT00663208|Secondary|Correlation Coefficients Between Measures of Decline in log10 Hepatitis C Virus (HCV) RNA and Daclatasvir PK Parameters Cmax, AUC(TAU), and Cmin on Day 14 in Participants Without Baseline Drug Resistance|Correlation between decline of log10 hepatitis C virus (HCV) RNA and exposure to study drug was measured by Pearson Correlation Coefficients. The change from baseline at Day 4 in log10 HCV RNA and the maximum decline in log10 HCV RNA were evaluated against the PK parameters Cmax, Cmin and AUC(TAU).|Day 4, Day 14|All participants who received at least 1 dose of daclatasvir and who had no baseline genotype resistance were analyzed. Placebo participants were excluded from this analysis.|||Correlation Coefficient|||Number
1230118|NCT00663208|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir on Days 1 and 14|Tmax was defined as the time to reach maximum observed plasma concentration of daclatasvir in plasma. Tmax was derived from plasma concentration-time data analyzed by non-compartmental methods. Tmax of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||h||Full Range|Median
1230119|NCT00663208|Secondary|Accumulation Index (AI) AUC(TAU), AI Cmax, and Degree of Fluctuation (DF) of Daclatasvir on Day 14|Accumulation index area under the concentration–time curve of daclatasvir to the end of the dosing period [AI AUC(TAU)] was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose.Accumulation index maximum observed concentration of daclatasvir in plasma (AI Cmax) was defined as the ratio of Cmax at steady-state to Cmax after the first dose. Degree of Fluctuation (DF) was defined as the ratio of difference between Cmax and Cmin at steady state by Css-av. The parameters were analyzed using non-compartmental methods, assayed by validated liquid chromatography tandem mass spectrometry (LC-MS/MS).|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1230120|NCT00663208|Secondary|Average Observed Plasma Concentration (Css-av) at Steady State of Daclatasvir at Days 1 and 14|The average observed plasma concentration at steady state (Css-av) was calculated as ratio of AUC(TAU) by TAU, where TAU = 24 h for QD dosing and 12 h for BID dosing. Css-av was derived from plasma concentration-time data analyzed by non-compartmental methods. Css-av of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11,13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1230121|NCT00663208|Secondary|Apparent Total Body Clearance (CLT/F) of Daclatasvir on Day 14|The apparent total body clearance at steady state (CLT/F) was defined as the apparent body clearance of canakinumab from the serum when the systemic availability was unknown. CLT/F was derived from plasma concentration-time data analyzed by non-compartmental methods. CLT/F of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1230122|NCT00663208|Secondary|Plasma Half-life (T-half) of Daclatasvir at Day 14|The absolute values of lamda (λ) were used to evaluate apparent terminal half-life (T-half) was defined as T-half= ln 2/λ. T-half was derived from plasma concentration-time data analyzed by non-compartmental methods. T-half of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||h||Standard Deviation|Mean
1230123|NCT00663208|Secondary|Area Under the Concentration-time Curve (AUC) in 1 Dosing Interval of Daclatasvir at Days 1 and 14|The area under the concentration-time curve in 1 Dosing Interval AUC(TAU) was used to measure the drug exposure over 1 dosing interval., derived from plasma concentration-time data analyzed by non-compartmental methods. AUC(TAU) of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1231152|NCT00656058|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 71 months and 17 days||||Participants|||Count of Participants
1230124|NCT00663208|Secondary|Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Daclatasvir on Days 1 and 14|The peak concentrations in plasma (Cmax) and minimum observed plasma concentration (Cmin) were defined as the peak maximum and minimum plasma level of daclatasvir, derived from plasma concentration-time data analyzed by non-compartmental methods. Cmax and Cmin of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13 and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available Pharmacokinetic (PK) data were summarized.|||nanograms/milliliters(ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1230125|NCT00663208|Secondary|Maximum Decline From Baseline in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL.|Day 1 up to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.|||log10 IU/mL||Standard Deviation|Mean
1230126|NCT00663208|Secondary|Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|Participants without baseline drug resistance were assessed for time to reach maximum decrease in log10 HCV RNA level.|Day 1 up to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.|||Days||Standard Deviation|Mean
1230127|NCT00663208|Secondary|Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.|||log10 IU/mL||90% Confidence Interval|Mean
1230128|NCT00663208|Secondary|Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline to Day 4|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.|||log10 IU/mL||90% Confidence Interval|Mean
1230129|NCT00663208|Secondary|Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations were summarized.|||log10 IU/mL||Standard Deviation|Mean
1230130|NCT00663208|Primary|Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline, Day 7|All randomized participants who took at least 1 dose of study medication.|||log10 IU/mL||90% Confidence Interval|Mean
1230131|NCT00663208|Secondary|Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 international units/ millilitre (IU/mL). Baseline was Day -1|Baseline, Day 7|All randomized participants who took at least 1 dose of study medication.|||log10 IU/mL||90% Confidence Interval|Mean
1230132|NCT00663169|Secondary|Number of Patients Who Took Rescue Medication|Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.|4 months|All participants.|||Participants|||Number
1230133|NCT00663169|Secondary|Change From Baseline in Pain Using a Visual Analog Scale at Month 4|Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.|||Score on a scale||Standard Deviation|Mean
1230134|NCT00663169|Secondary|ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period|Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).|Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.|||μg/mL||Standard Deviation|Mean
1230135|NCT00663169|Secondary|Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4|Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.|||mg/L||Standard Deviation|Mean
1230136|NCT00663169|Secondary|Change in C-reactive Protein (CRP) From Baseline at Month 4|Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.|||mg/L||Standard Deviation|Mean
1230137|NCT00663169|Secondary|Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study|Additional safety information can be found in the Adverse Event section.|4 months||||Participants|||Number
1230138|NCT00663169|Secondary|Time to Walk Independently (if Applicable) During Treatment Period||4 months|Since the study recruited only 6 subjects this analysis was not done.||||||
1230139|NCT00663169|Secondary|Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period|Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.|4 months|Since the study recruited only 6 subjects this analysis was not done.||||||
1230140|NCT00663169|Secondary|Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period||72 hours|Since the study only recruited 6 subjects this analysis was not done.||||||
1230141|NCT00663169|Primary|Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale|72 hours following treatment, patients were asked the question: “How would you rate the improvement in your gout since receiving the study medication?” Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a “good” or “excellent” response.|72 hours|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.|||Percentage of participants|||Number
1230142|NCT00663117|Secondary|Histology Inflammatory Score by Colon Biopsies|Histology scores to assess microscopic inflammation and structural architecture were determined at baseline and after 12 weeks of either naltrexone therapy or placebo by mucosal biopsy samples obtained during colonoscopies.The pathology specimens were reviewed and scored by a Pathologist blinded to the treatment. The mean scores at baseline were the same between both groups.Differences between naltrexone and placebo treated subjects was assessed.The range in scores could be 0-25, with 0 representing no inflammation and 25 being maximum or severe inflammation..|12 weeks|Tissue was removed by biopsy in those undergoing colonoscopy|||units on a scale||Standard Error|Mean
1230143|NCT00663117|Secondary|Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy|A secondary outcome was the appearance of the colonic mucosa on endoscopy using the Crohn’s Disease Endoscopic Index of Severity (CDEIS) score described by Mary et al. Gut 1989;30:983–989.This score ranges from 0-44 based upon the extent and severity of inflammation and ulcers seen during endoscopy of the colon. A response is a drop of > 5 points from baseline. Endoscopic remission is a score of < 6 and Complete endoscopic remission is a score of > 3.|12 weeks|Sample size was calculated under the assumption that at least 60% of the naltrexone-treated patients, and no more than 10% of the placebo-treated patients, would respond with at least a 70-point decline in CDAI scores. With a 10% withdrawal rate, 40 subjects yields an 86% power using a two-sided, 0.05-significance level Fisher’s exact test.|||percentage of patients|||Number
1230144|NCT00663117|Secondary|Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey)|IBDQ (Inflammatory bowel Disease questionnaire) contains questions about health ranging from a score of poor (i.e., 32) to excellent (i.e., 224) an increase from baseline indicates improvement in quality of life.|Between baseline and 3 months|Same as sample size calculation|||percentage of change||Standard Error|Mean
1230145|NCT00663117|Primary|Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;|The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.|3 months||||percentage of pts|||Number
1230146|NCT00663052|Other Pre-specified|Mean Number of Doctor Visits|As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Visits||Standard Deviation|Mean
1230147|NCT00663052|Other Pre-specified|Percentage of Participants With Doctor Visits|As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Percentage of participants|||Number
1230148|NCT00663052|Other Pre-specified|Mean Number of Emergency Room Days|As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Days||Standard Deviation|Mean
1230149|NCT00663052|Other Pre-specified|Percentage of Participants With Emergency Room Visits|As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Percentage of participants|||Number
1230150|NCT00663052|Other Pre-specified|Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores|FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue. For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue. The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13. If more than 6 items were missing, the total score was missing.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
1230151|NCT00663052|Other Pre-specified|Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24|MOS: participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
1230587|NCT00660699|Secondary|Disease Free Survival (DFS) - Median|DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.|Median follow-up was 24 months (range 3.2-97 months)|30 out of 48 participants completed all components of the study therapy.|||months||95% Confidence Interval|Median
1230152|NCT00663052|Other Pre-specified|Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12|MOS scale has 12 questions to assess sleep quality & quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed. Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12. All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.|Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
1230153|NCT00663052|Other Pre-specified|Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24|WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).|Week 24|mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.|||Percentage of indicated parameter||Standard Deviation|Mean
1230154|NCT00663052|Other Pre-specified|Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12|WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).|Week 12|mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.|||Percentage of indicated parameter||Standard Deviation|Mean
1230155|NCT00663052|Other Pre-specified|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230156|NCT00663052|Other Pre-specified|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230157|NCT00663052|Other Pre-specified|Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (example confined to bed). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state."|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230158|NCT00663052|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230159|NCT00663052|Other Pre-specified|Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
1233037|NCT00636987|Primary|Number of Participants With Adverse Events|Number of participants with Adverse Events|5 Years||||participants|||Number
1230160|NCT00663052|Other Pre-specified|Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
1230161|NCT00663052|Secondary|Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.|Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
1230162|NCT00663052|Secondary|Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.|Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
1230163|NCT00663052|Other Pre-specified|Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24|Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either ‘satisfactory’ or ‘not satisfactory.’ These are: 1) whether the participant’s current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant’s current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
1230164|NCT00663052|Other Pre-specified|Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24|Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either ‘satisfactory’ or ‘not satisfactory.’ These are: 1) whether the participant’s current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant’s current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
1230165|NCT00663052|Other Pre-specified|Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12|PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale. Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree. The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.|Baseline, Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230166|NCT00663052|Secondary|Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24|Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12.|From Week 12 to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
1230167|NCT00663052|Secondary|Change From Baseline in the Photographed Image of Lesions in Selected Participants|Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes. Measured as yes or no for change.|Baseline to Week 24|The data was not collected as planned.|||Units on scale|||Number
1230168|NCT00663052|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24||Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of BSA||Standard Deviation|Mean
1230588|NCT00660699|Secondary|Disease Free Survival (DFS) - Median|DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.|Median follow-up was 24 months (range 3.2-97 months)||||months||95% Confidence Interval|Median
1230169|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24|SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230170|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24|SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230171|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24|SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230172|NCT00663052|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230173|NCT00663052|Secondary|Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks|Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median. Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Days||95% Confidence Interval|Median
1230174|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
1230175|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
1230176|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
1230177|NCT00663052|Secondary|Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks|Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median. PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI. PASI score percent improvement =100*(baseline score - visit score)/baseline score.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. Observed cases (OC) analyses were performed including only those participants who were evaluated at the specified visits.|||Days||95% Confidence Interval|Median
1230178|NCT00663052|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI. For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
1230179|NCT00663052|Secondary|Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
1230180|NCT00663052|Secondary|Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
1230181|NCT00663052|Secondary|Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
1230182|NCT00663052|Secondary|Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
1230183|NCT00663052|Primary|Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 24|Modified intent-to-treat (mITT) population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.|||Percentage of participants|||Number
1230184|NCT00663039|Secondary|Facial Affect Recognition|This computer administered test includes 40 color photographs of four universal emotions (happy, sad, angry, and fearful) balanced for the posers gender, age, and ethnicity, including four low intensity and four high-intensity facial expressions of each emotion, plus 8 neutral faces. The stimuli are presented in random order and subjects are asked to identify which stimuli were presented to them at the end. Performance on this test correlates with negative symptom severity.|10 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of responses||Standard Deviation|Mean
1230185|NCT00663039|Secondary|Reading the Mind in the Eyes|A 30 item task presents a picture of a person's eyes and the participant is ask to determine the person's mental state from 4 multiple choice options.|10 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of correct responses||Standard Deviation|Mean
1230186|NCT00663039|Secondary|Brief Smell Identification Test|The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor.|5 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of correct responses||Standard Deviation|Mean
1230187|NCT00663039|Secondary|Brief Assessments of Cognition for Schizophrenia|The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer and provides a highly reliable measure of processing speed. There are nine symbols code 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches is the participants score. Scores range from 0-110.|5 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of correct responses||Standard Deviation|Mean
1230188|NCT00663039|Secondary|Rapid Visual Information Processing Test (RVIP)|RVIP measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600ms; the subjects respond when they see a target sequence of 3 odds or 3 even digits in a consecutive sequence. Two target sequences are separated by a minimum of 5 and maximum of 30 non-target digits. There are a total of 48 target sequences during each test block. The number of correctly Identified target sequences or hits is recorded, as well as, false alarms (incorrectly identified target sequences) and reaction times.|25 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of responses||Standard Deviation|Mean
1230189|NCT00663039|Secondary|RVIP Reaction Times|Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when they see a target sequence of 3 odds or 3 even digits in a consecutive sequence. Two target sequences are separated by a minimum of 5 and maximum of 30 non-target digits|25 minutes|Analyzable data for secondary outcomes was not available for some participants.|||milliseconds||Standard Deviation|Mean
1230190|NCT00663039|Secondary|Trust Game|Participants competed in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds the participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive an portion of the total offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240.|20 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Dollars||Standard Deviation|Mean
1230191|NCT00663039|Secondary|Hopkins Verbal Learning Test (HVLT)|HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first study day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials.|15 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of correct responses||Standard Deviation|Mean
1230192|NCT00663039|Primary|Social Affiliation Measured by Social Affiliative Role Play|In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. Participants are rated on a 5 point Likert scale ranging from very poor (1) to Very Good (5).|30 minutes|Of the 27 ppts that were screened and deemed eligible for study participation, only 19 completed testing while receiving oxytocin and only 18 complete testing while receiving placebo.|||units on a scale||Standard Deviation|Mean
1230193|NCT00663026|Secondary|Apparent Systemic Clearance (CL/F)|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||milliliter/hour/kilogram (mL/hr/kg)||Standard Deviation|Mean
1230194|NCT00663026|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
1230195|NCT00663026|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F).|||hours||Full Range|Median
1230196|NCT00663026|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|t1/2 not calculated due to inadequate characterization of the terminal elimination phase.||||||
1230197|NCT00663026|Secondary|Average Serum Concentration at Steady State (Cavg,ss)|Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1230198|NCT00663026|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|Pharmacokinetic (PK) analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, time to maximum concentration [tmax], area under the curve [AUC], terminal elimination half-life [t1/2], apparent systemic clearance [CL/F], and apparent volume of distribution [Vz/F]).|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1230199|NCT00663026|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after Week 25 dose|Safety population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1230200|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1230201|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1230202|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1230203|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1230204|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1230205|NCT00662909|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Percentage of participants|||Number
1230206|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Physician visits||Standard Deviation|Mean
1230207|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled ‘No, not at all’ on the left (=0) to ‘Yes, completely satisfied’ on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1230208|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1230209|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Deviation|Mean
1230210|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percent activity impairment||Standard Deviation|Mean
1230211|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent overall work impairment||Standard Deviation|Mean
1230212|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent impairment while working||Standard Deviation|Mean
1230213|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent work time missed||Standard Deviation|Mean
1235159|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
1230214|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.|||Scores on a scale||Standard Error|Least Squares Mean
1230215|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.|||Scores on a scale||Standard Error|Least Squares Mean
1230216|NCT00662909|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||Percentage of participants|||Number
1230217|NCT00662909|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||Percentage of participants|||Number
1230218|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||pads||Standard Error|Least Squares Mean
1230219|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis.~N is the number of participants included at each time point."|||Nocturia episodes||Standard Error|Least Squares Mean
1230220|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.|||Scores on a scale||Standard Error|Least Squares Mean
1230221|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||Urgency episodes||Standard Error|Least Squares Mean
1230222|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.|||Urgency incontinence episodes||Standard Error|Least Squares Mean
1230223|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as “N”.|||mL||Standard Error|Least Squares Mean
1230224|NCT00662909|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not used in this analysis. The number of patients included in the calculation for each time point is noted as “N”.|||Micturitions||Standard Error|Least Squares Mean
1230225|NCT00662909|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
1230226|NCT00662909|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not used in this analysis.|||Micturitions||Standard Error|Least Squares Mean
1230227|NCT00662909|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not used in this analysis.|||Incontinence episodes||Standard Error|Least Squares Mean
1230228|NCT00662909|Secondary|Change From Baseline to Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.|||mL||Standard Error|Least Squares Mean
1230229|NCT00662909|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.|||Micturitions||Standard Error|Least Squares Mean
1230315|NCT00662129|Secondary|Overall Survival Time|Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||months||95% Confidence Interval|Median
1230230|NCT00662909|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12 (Final Visit)|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was used in this analysis.|||Incontinence episodes||Standard Error|Least Squares Mean
1230231|NCT00662857|Primary|Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro|Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)|0 to 360 minutes post-dose|"Rapid-acting insulin Analogue (RAA) Population~All subjects who had serum insulin concentration data for both TI Inhalation Powder B and insulin lispro and were deemed to be protocol compliant (no major protocol violations during the clinical trial)."|||(micro U)*min/mL||Standard Error|Least Squares Mean
1230232|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax||0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).|||min||Full Range|Median
1230233|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.|Maximum observed baseline-corrected serum insulin concentration|0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).|||(micro U)/mL||Standard Error|Least Squares Mean
1230234|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360|Dose-normalized baseline-corrected area under the serum insulin vs. time curve|0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).|||(micro U)*min/mL||Standard Error|Least Squares Mean
1230235|NCT00662831|Other Pre-specified|Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||hemorrhages|||Number
1230236|NCT00662831|Other Pre-specified|Number of Major and Minor Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||hemorrhages|||Number
1230237|NCT00662831|Other Pre-specified|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||hemorrhages|||Number
1230238|NCT00662831|Secondary|Transcutaneous Local Tissue Oxygenation (pO2)|Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were analyzed at selected sites only, based on availability. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1230239|NCT00662831|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant’s pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1230378|NCT00661713|Secondary|GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination|Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.|||Ratio||95% Confidence Interval|Geometric Mean
1230240|NCT00662831|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1230241|NCT00662831|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||mm||Standard Deviation|Mean
1230242|NCT00662831|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1230243|NCT00662831|Secondary|Median Time to First Amputation||Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||||||
1230244|NCT00662831|Secondary|Time to Intact Skin Healing|Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||||||
1230245|NCT00662831|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|Major cardiovascular events were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||||||
1230246|NCT00662831|Secondary|Number of Participants Who Died||Week 24 (EOT) or early termination|ITT population included all participants who were randomized.|||participants|||Number
1230247|NCT00662831|Secondary|Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing|University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||participants|||Number
1230248|NCT00662831|Secondary|Number of Participants Who Underwent Major and Minor Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized.|||participants|||Number
1230249|NCT00662831|Secondary|Number of Participants Who Underwent Any Amputation|Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized.|||participants|||Number
1230250|NCT00662831|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||participants|||Number
1230270|NCT00662649|Primary|Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free|A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.|Core baseline to end of study (maximum up to 60 months)|Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.|||Percentage of patients||95% Confidence Interval|Number
1230251|NCT00662831|Primary|Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing|University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 [end of treatment (EOT)] or early termination|Intention to treat (ITT) population included all participants who were randomized. Last observation carried forward (LOCF) method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||participants|||Number
1230252|NCT00662818|Secondary|Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose|SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.|Up to 24 hours post-dose (Up to 14 weeks)|The FAS population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.|||Percentage of Participants||95% Confidence Interval|Number
1230253|NCT00662818|Secondary|Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether nausea was present or absent at each of the predefined time points.|2 hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for nausea prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.|||Percentage of Participants||95% Confidence Interval|Number
1230254|NCT00662818|Secondary|Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.|2 Hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for photophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.|||Percentage of Participants||95% Confidence Interval|Number
1230255|NCT00662818|Secondary|Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.|2 hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for phonophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.|||Percentage of participants||95% Confidence Interval|Number
1230256|NCT00662818|Secondary|Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose|Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.|Up to 48 hours after the dose of any study medication (Up to 14 weeks)|The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.|||Participants|||Number
1230257|NCT00662818|Primary|Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 48 hours post-dose (Up to 14 weeks)|The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.|||Participants|||Number
1230258|NCT00662818|Primary|Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Within 14 days of any dose of study medication (Up to 16 weeks)|All-Patients-as-Treated (APaT) population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.|||Participants|||Number
1230259|NCT00662818|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)|Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose (Up to 6 weeks)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of Participants||95% Confidence Interval|Number
1230282|NCT00662558|Secondary|Physician's Global Assessment of Disease Activity|"Number of subjects with a physician's grading of disease activity using the Physician’s Global Assessment of Disease Activity 5-point scale ((1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as Improved if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as Worsened if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as No Change otherwise."|Week 6/ET|ITT. Number of subjects with Physician's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=368, tramadol HCl n=361.|||participants|||Number
1230260|NCT00662818|Primary|Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)|Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose (Up to 6 weeks)|The full-analysis set (FAS) included participants treated for a migraine attack. Participants had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of participants||95% Confidence Interval|Number
1230261|NCT00662675|Secondary|Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase|Percent of patients reporting nausea, vomiting, bloating, diarrhea, oily/greasy stools, and abdominal pain signs and symptoms reported as Adverse events during the double-blind phase.|Entire 7 days double-blind phase|ITT|||Percent of participants|||Number
1230262|NCT00662675|Secondary|Change in Percent COA-Protein (Nitrogen)|The change in percent COA-protein from the stool collection period in double-blind phase to open-label phase|72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase.|ITT|||percentage COA-protein||Standard Deviation|Mean
1230263|NCT00662675|Primary|Change in the Coefficient of Fat Absorption (COA-fat Percent)|Change in the coefficient of fat absorption (percent COA-fat) from the 72-hour inpatient period in the open-label phase to the 72-hour period inpatient period in the double-blind (withdrawal) phase.|72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase.|Intent-to-Treat (ITT)|||percentage COA-fat||Standard Deviation|Mean
1230264|NCT00662649|Secondary|Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression|Kurtzke’s Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.|Core baseline to end of study (maximum up to 60 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.|||Percentage of patients||95% Confidence Interval|Number
1230265|NCT00662649|Secondary|Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Months 0 to end of study (maximum up to 60 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. This analysis included only patients with value at both core baseline and end of study.|||Percent change||Standard Deviation|Mean
1230266|NCT00662649|Primary|Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.|||Ratio of relapses per year||95% Confidence Interval|Number
1230267|NCT00662649|Primary|Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.|||Relapses per year||95% Confidence Interval|Number
1230268|NCT00662649|Secondary|Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.|||Percent change||Standard Deviation|Mean
1230269|NCT00662649|Secondary|Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.|||Percentage of patients|||Number
1230271|NCT00662649|Secondary|Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.|||Lesions||Standard Deviation|Mean
1230272|NCT00662649|Primary|Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0 to end of study (maximum up to 60 months)|Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.|||Relapses per year||95% Confidence Interval|Number
1230273|NCT00662558|Secondary|Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ|Subjects were successful responders if they had: > = 30% improvement from baseline to final visit in VAS assessment (as identified by 100 millimeter scale); > = 30% improvement from baseline to final visit in Patient's Global assessment (classified as improved if assessment reduced at least 2 grades from baseline or if assessment changed to Grade 1, worsened if assessment increased at least 2 grades from baseline or if assessment changed to Grade 5, or no change; and < 20% worsening from baseline to final visit in RMDQ assessment (lower scores indicated greater disability).|Week 6/ET|ITT|||participants|||Number
1230274|NCT00662558|Secondary|Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)|Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).|Week 6/ET|ITT. Number of subjects with Patient's Satisfaction Questionnaire (with walking and bending ability scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.|||participants|||Number
1230275|NCT00662558|Secondary|Patient's Satisfaction Questionnaire (With Pain Relief Scale)|Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).|Week 6/ET|ITT. Number of subjects with Patient's Satisfaction Questionnaire (with pain relief scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.|||participants|||Number
1230276|NCT00662558|Secondary|Patient's Global Evaluation of Study Medication|Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.|Weeks 1, 3, and 6/ET|ITT.|||participants|||Number
1230277|NCT00662558|Secondary|Change From Baseline in Work Limitations Questionnaire (WLQ)|The WLQ included the following: Time Scale, Physical Scale, Output Scale, Mental-Interpersonal Scale, and Index Scale. The scales ranged from 0 (Limited none of the time) to 100 (Limited all of the time). A negative change indicated subject improvement.|Baseline, Week 6/ET|ITT. Number of subjects with WLQ scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.|||scores on a scale||Standard Error|Mean
1230278|NCT00662558|Secondary|Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores|The Optimal Scale is scaled from 0 or 1 with 1 indicating 7 or 8 hours of sleep per night and 0 otherwise. Number of subjects with change of improvement (0 to 1), no change (1 to 1 or 0 to 0), or worsening (1 to 0) from baseline as indicated by the MOS Optimal sleep scale.|Baseline, Week 6/ET|ITT. Number of subjects with MOS Optimal sleep scale scores at Week 6/ET: celecoxib n=373, tramadol HCl n=365.|||participants|||Number
1230279|NCT00662558|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale|MOS sleep scale included the following attributes: sleep disturbance, snoring, awaken shortness of breath or headache, quantity of sleep, sleep adequacy, somnolence, Sleep Problem Index I, and Sleep Problem Index II. Score ranged from 0-100, with a higher score indicating more of the scale attribute (e.g., more sleep disturbance, etc.). A negative change indicated subject improvement. MOS sleep scale: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Number of subjects with MOS scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.|||scores on a scale||Standard Error|Mean
1230280|NCT00662558|Secondary|Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)|m-BPI-sf scale assessed pain severity (0 = no pain to 10 = worst possible pain), and pain interference of functional activities (0 = does not interfere to 10 = completely interferes) during the 24 hour follow-up period. Subjects indicated: how much pain now; worst pain; average level of pain; how much pain interfered with general activity, mood, walking ability, relations with other people, sleep, normal work (including housework), and enjoyment of life. m-BPI-sf: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with m-BPI-sf scores at Baseline and Week 6/ET: celecoxib n=373, tramadol HCl n=367.|||scores on a scale||Standard Error|Mean
1230281|NCT00662558|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score|Each subject assessed his/her own disability due to low back pain using the RMDQ worksheet, which consisted of 24 statements of disability. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total scores could have ranged from 0 to 24, with higher scores indicating greater disability. RMDQ: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with Roland-Morris Disability total scores at Baseline and Week 6/ET= celecoxib n=391, tramadol n=389.|||scores on a scale||Standard Error|Mean
1230302|NCT00662311|Secondary|Radiological Response Rate as Assessed by CT|Count of participants with stable disease or partial response. Patients were evaluated for treatment response per RECIST criteria (version 1.0).|12 weeks post-treatment, then every 3 months for 2 years, and then every 6 months for a year thereafter||||Participants|||Count of Participants
1235160|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.||Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1230283|NCT00662558|Secondary|Patient's Global Assessment of Disease Activity|"Number of subjects with a graded level of disease activity using the Patient’s Global Assessment of Disease Activity 5-point scale (1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as Improved if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as Worsened if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as No Change otherwise."|Week 6/ET|ITT. Number of subjects with Patient's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=375, tramadol HCl n=367.|||participants|||Number
1230284|NCT00662558|Secondary|Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)|VAS was a 100 millimeter (mm) scale that subjects used to assess the severity of their lower back pain. Based on the following question, “During the past day, how much back pain did you have?”, the subject was instructed to place a vertical line on the VAS to indicate the magnitude of his/her lower back pain. 0 mm = no pain and 100 mm = worst possible pain. VAS: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with VAS scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.|||mm||Standard Error|Mean
1230285|NCT00662558|Secondary|Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with NRS-Pain scale scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.|||scores on a scale||Standard Error|Mean
1230286|NCT00662558|Primary|Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)|A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).|Week 6 or Early Termination (ET)|Intent-to-treat = all subjects who were randomized and received at least one dose of study medication. Missing values were imputed using last observation carried forward (LOCF).|||participants|||Number
1230287|NCT00662545|Secondary|HIV RNA < 75 Copies/ml||entry, week 12, and week 24||||participants|||Number
1230288|NCT00662545|Secondary|Incidence of ALT Flares|ALT flare: sudden increase in blood level of alanine transaminase (ALT)|every 4 weeks for 24 weeks||||participants|||Number
1230289|NCT00662545|Secondary|Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)||every 4 weeks for 24 weeks||||participants|||Number
1230290|NCT00662545|Secondary|Incidence of Permanent Discontinuation Due to Toxicity||24 weeks||||participants|||Number
1230291|NCT00662545|Primary|Hepatitis B Virus (HBV) DNA|HBV DNA carries the genetic blueprint of the virus. How many HBV DNA “particles” or “copies” are found in the blood indicates how rapidly the virus is reproducing in the liver.|week 24||||log 10 IU/ml||Full Range|Median
1230292|NCT00662532|Secondary|BOP Percent Reduction From Baseline|Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline|at Day 90 and Day 180|ITT|||Percentage of Participants||Standard Deviation|Least Squares Mean
1230293|NCT00662532|Secondary|Initial PD Reduction|Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject|Baseline to Day 90||||mm||Standard Deviation|Mean
1230294|NCT00662532|Primary|Overall PD Reduction|Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject|Baseline to Day 180||||mm||Standard Deviation|Mean
1230295|NCT00662389|Primary|Serious Adverse Events|Number of Serious Adverse Events|Immediate||||Number of Serious Adverse Events|||Number
1230296|NCT00662363|Primary|Change in Patient Assessment of Constipation - Quality of Life|The second component of the PAC is the quality of life (QOL) component.The quality of life (QOL) component consists of five items that are rated on a 0-4 scale with higher scores indicating better QOL. Scores within the domains are averaged.|Baseline and day 7|intention to treat|||units on a scale||Standard Deviation|Mean
1230297|NCT00662363|Primary|Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)|Patient Assessment of Constipation (PAC) – Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items).|Baseline and Day 7, after treatment completed (6 days of treatment)|All subjects randomized and who had baseline and endpoint data were included in the intention to treat analysis.|||units on a scale||Standard Deviation|Mean
1230298|NCT00662311|Secondary|Safety and Toxicity of Vorinostat at the MTD as Assessed by NCI CTCAE Version 3.0|Count of participants with a grade 3 or higher toxicity. Toxicities were assessed using the NCI CTCAE (v3.0). Grade 3 or higher toxicities were considered worse.|Weekly during treatment, 30 days post-treatment, and 12 weeks post-treatment||||Participants|||Count of Participants
1230299|NCT00662311|Secondary|Overall Survival|Kaplan-Meier estimate|1 year||||survival probability||95% Confidence Interval|Number
1230300|NCT00662311|Secondary|Progression-free Survival|Kaplan-Meier estimate. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|1 year||||progression free survival probability||95% Confidence Interval|Number
1230301|NCT00662311|Secondary|Duration of Response||Up to 3 years||||months||Full Range|Median
1235161|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.||Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1230303|NCT00662311|Primary|MTD of Vorinostat When Administered in Combination With Paclitaxel and Radiotherapy Therapy as Assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)|Defined as the highest dose level at which no more than 1 of 6 patients experiences dose-limiting toxicity (DLT). Toxicity was graded according to the National Institutes of Health Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. A DLT was defined as any Grade 3 or higher non-hematologic adverse event with the exception of alopecia, fatigue, or anorexia. Nausea and/or vomiting that persisted > 48 hours despite optimal medical management at grade 3 or higher was considered a DLT. Hematologic dose-limiting toxicity was defined as either: Grade 4 neutropenia lasting for ≥ 7 days in duration, Grade > 3 febrile neutropenia with/without infection, Grade 4 thrombocytopenia or Grade 5 hematologic toxicity.|8 weeks||||mg|||Number
1230304|NCT00662207|Primary|Number of Participants With a Urethral Sphincter Contractions||3 hour recording session||||participants|||Number
1230305|NCT00662207|Primary|Number of Participants With a Change in Anal Sphincter Pressure|Measured via balloon catheter|3 hour recording session||||participants|||Number
1230306|NCT00662207|Primary|Number of Participants With a Change in External Urethral Pressure|Measured via balloon catheter|3 hour recording session||||participants|||Number
1230307|NCT00662207|Primary|Number of Participants With a Change in Bladder Pressure|Measured via pressure catheter in bladder with a pressure transducer|3 hour recording session||||participants|||Number
1230308|NCT00662155|Primary|Overall Average Sleep Efficiency (%)|The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep efficiency (total sleep time/time in bed x 100) as a function of treatment.|12-week average during Phase 3|These were participants that meant compliance criteria and were included in all analyses.|||percent sleep efficiency||Standard Error|Mean
1230309|NCT00662155|Primary|Overall Average Sleep Continuity Profile|The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep continuity as a function of treatment.|12-week average during Phase 3|These were participants that meant compliance criteria and were included in all analyses.|||minutes||Standard Error|Mean
1230310|NCT00662129|Secondary|Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8|"Quality of life (QOL) as measured by the mean change (from baseline) in FACT-B (TOI) Trial Outcome Index at Cycle 8 (24 weeks). FACT-B was scored according to the published scoring (*) criteria with higher scores representing better QOL. The FACT-B TOI was the sum of the following FACT-B subscale/scale scores: physical (score range 0-28), functional (score range 0-28), and Breast Cancer Subscale (score range 0-40); range of the FACT-B TOI is 0-96 (the change scores have a possible range of -96 to 96). The mean change and 95% confidence interval are reported below. A one-sample t-test is used to compare the change from baseline to a value of 0.~(*)= Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality of life instrument. J Clin Oncol 1997;15:974-986."|From baseline to end of Cycle 8; Up to 24 weeks|Of the participants evaluable for primary analysis, the Overall Number of Participants Analyzed reflects the number of subjects evaluable for this secondary outcome (with a FACT-B Trial Outcome Index score at baseline and at Cycle 8).|||units on a scale||95% Confidence Interval|Mean
1230311|NCT00662129|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||months||95% Confidence Interval|Median
1230312|NCT00662129|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years||||months||95% Confidence Interval|Median
1230313|NCT00662129|Secondary|Confirmed Response (Complete or Partial Response) Rate|A confirmed response is defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The confirmed response rate (percentage) will be estimated by the number of confirmed responses in evaluable patients divided by the total number of evaluable patients multiplied by 100. The appropriate confidence interval will be calculated based on the binomial distribution.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||percentage of patients with CR or PR||95% Confidence Interval|Number
1230314|NCT00662129|Secondary|PFS Time|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. The distribution of time to progression will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||months||95% Confidence Interval|Median
1230316|NCT00662129|Primary|6-month Progression-free Survival (PFS) Rate|The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|at 6 months|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||proportion of patients progression-free||95% Confidence Interval|Number
1230317|NCT00662038|Primary|Percentage of Participants With Adverse Events|An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.|7.5 years|All participants who received any pirfenidone.|||percentage of participants|||Number
1230318|NCT00662025|Secondary|t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).~n=Number of participants with analyzable data."|||hours||Standard Deviation|Mean
1230319|NCT00662025|Secondary|AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|"AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity.~5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil"|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants(Cohort 1).~n=Number of participants with analyzable data."|||nanogram∙hour/milliliter||Standard Deviation|Mean
1230320|NCT00662025|Secondary|Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil|Day 14 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 subjects (Cohort 1). n=Number of subjects with analyzable data.|||nanogram/milliliter||Standard Deviation|Mean
1230321|NCT00662025|Secondary|Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|"Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).~5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil"|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).~n=Number of participants with analyzable data."|||hours||Full Range|Median
1230322|NCT00662025|Secondary|AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose.~The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).|||nanogram∙hour/milliliter||Standard Deviation|Mean
1230323|NCT00662025|Secondary|Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration.~The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).|||nanogram/milliliter||Standard Deviation|Mean
1230324|NCT00662025|Secondary|Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).~The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).|||hours||Full Range|Median
1230325|NCT00662025|Secondary|Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).|||nanogram/milliliter||Standard Deviation|Mean
1230326|NCT00662025|Secondary|Overall Survival (OS)|OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death.|A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||months||Full Range|Median
1230327|NCT00662025|Secondary|Time to Objective Tumor Response (TTR)|Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|"FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.~Twenty three participants with objective tumor response were analyzed for TTR."|||months||95% Confidence Interval|Median
1230379|NCT00661713|Secondary|GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.|||IU/ml||95% Confidence Interval|Geometric Mean
1230328|NCT00662025|Secondary|Duration of Objective Tumor Response (DR)|Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|"FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.~Nineteen participants with objective tumor response were analyzed for DR."|||months||95% Confidence Interval|Median
1230329|NCT00662025|Secondary|Time to Tumor Progression (TTP)|Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|FAS is defined as the population of all enrolled patients who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||months||95% Confidence Interval|Median
1230330|NCT00662025|Secondary|Progression-Free Survival (PFS)|Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||months||95% Confidence Interval|Median
1230331|NCT00662025|Secondary|Number of Subjects With CBR Based on Investigator's Assessment|Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||participants|||Number
1230332|NCT00662025|Secondary|Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment|Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||participants|||Number
1230333|NCT00662025|Secondary|Number of Participants With Objective Response Based on Investigator's Assessment|Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||participants|||Number
1230334|NCT00662025|Primary|Number of Participants With Objective Response Based on Data Review Committee's Assessment|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.|Full Analysis Set (FAS) is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||participants|||Number
1230335|NCT00662012|Secondary|Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .|Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease.|5 years|Analysis per protocol|||participants|||Number
1230336|NCT00662012|Primary|The Primary Safety Endpoint - Frequency of Complications of Therapy|The primary safety endpoint is the frequency of complications of therapy|5 years|Analysis was per protocol|||participants|||Number
1230337|NCT00661999|Secondary|Transferrin Saturation at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks||||Percentage Saturation||Standard Deviation|Mean
1230338|NCT00661999|Secondary|Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16|MCV is a measure of the average red blood cell volume.|Baseline, 7 weeks and 16 weeks||||fL||Standard Deviation|Mean
1230339|NCT00661999|Secondary|Ferritin Level at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks||||µg/L||Standard Deviation|Mean
1230340|NCT00661999|Secondary|Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16||1 week, 7 weeks and 16 weeks||||mg/L||Standard Deviation|Mean
1230341|NCT00661999|Secondary|C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16||1 Week, 7 Weeks and 16 Weeks||||mg/L||Standard Deviation|Mean
1235162|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.||Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1230342|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study|FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.|Baseline and 16 weeks||||Scores on a scale||Standard Deviation|Mean
1230343|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study|Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.|Baseline and 16 weeks||||Scores on a scale||Standard Deviation|Mean
1230344|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study|SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.|Baseline and 16 weeks||||Scores on a scale||Standard Deviation|Mean
1230345|NCT00661999|Secondary|Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)|Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.|Baseline and 16 weeks||||Scores on a scale||Standard Deviation|Mean
1230346|NCT00661999|Secondary|Time to First Red Blood Cell (RBC) Transfusions||16 weeks|Only 63 participants (20 DA + IV Iron, 21 DA + Oral Iron and 22 DA + Placebo) needed RBC transfusion during 16 weeks of treatment period. Thus, median of time to first RBC transfusion and 95 % confidence interval are not attainable.|||Days||95% Confidence Interval|Median
1230347|NCT00661999|Secondary|Time to Hematopoietic Response|Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.|16 weeks||||Days||95% Confidence Interval|Median
1230348|NCT00661999|Secondary|Mean Increment in Hemoglobin Level at Week 16|Value at 16 weeks minus value at baseline.|Baseline and 16 weeks||||g/dL||Standard Deviation|Mean
1230349|NCT00661999|Secondary|Mean Increment in Hemoglobin Level at Week 7|Value at 7 weeks minus value at baseline.|Baseline and 7 weeks||||g/dL||Standard Deviation|Mean
1230350|NCT00661999|Secondary|Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions||Week 1 to Week 16||||Participants|||Number
1230351|NCT00661999|Secondary|Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL||16 Weeks||||Percentage of Participants|||Number
1230352|NCT00661999|Primary|Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response|Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.|16 Weeks||||Participants|||Number
1230353|NCT00661960|Primary|the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time.|Duodenal tissue immune cell subsets were measured by flow cytometry.|nine months|all subjects who completed all study visits|||% CD3/CD4 T-cells in GALT tissue||Inter-Quartile Range|Median
1230354|NCT00661895|Secondary|New Onset Diabetes Mellitus||3 month intervals|||||||
1230355|NCT00661895|Primary|Percentage of Subjects Achieving Blood Pressure Goals|Percentage of subjects who achieved JNC-VII defined blood pressure goals.|3 month intervals||||percentage of participants|||Number
1230356|NCT00661830|Secondary|Time to Objective Response|Time to Objective Response (OR) is defined as the time from start of treatment to objective tumor response (CR or PR) is first documented according to the RECIST tumor response criteria during treatment or until 30 days after termination of active therapy. Response must subsequently be confirmed. For subjects failing to achieve an objective response and who did not progress during the trial, time to objective response will be censored at their last date of tumor evaluation.|one year|All subjects who receive at least one dose of trial treatment and had no progression during the trial are included in the analysis|||days||95% Confidence Interval|Median
1230357|NCT00661830|Secondary|Best Overall Response|"Best Overall Response (BOR) is defined as the best tumor response (confirmed partial or complete response, stable disease) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. Best response is determined from the sequence of responses assessed. For complete response (CR) or partial response (PR), best response must be confirmed by a second assessment within 4 -6 weeks.~Two objective status determinations of CR before progression are required for a best response of CR.~Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR.~Best response of Stable Disease (SD) is defined as disease that does not meet the criteria of CR, PR or Progressive Disease (PD) and has been evaluated at least one time, at least 6 weeks after baseline assessment."|one year|All subjects who receive at least one dose of trial treatment are included in the analysis.|||participants|||Number
1230358|NCT00661830|Secondary|Overall Survival|Overall Survival (OS) is measured from start of treatment to death due to any cause until end of follow-up period. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored at the date of the last observation.|one year|All subjects who receive at least one dose of trial treatment are included in the analysis|||days||95% Confidence Interval|Median
1230380|NCT00661713|Secondary|Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.|||Ratio||95% Confidence Interval|Geometric Mean
1230381|NCT00661713|Secondary|Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
1230359|NCT00661830|Primary|Progression-free Survival (PFS)|The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method.|one year|All subjects who receive at least one dose of trial treatment are included in the analysis.|||days||95% Confidence Interval|Median
1230360|NCT00661778|Secondary|1-year Survival|The probability of surviving 1 year was estimated using the Kaplan-Meier method.|Baseline to 1 year|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1230361|NCT00661778|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 4 years)|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.|||Months||95% Confidence Interval|Median
1230362|NCT00661778|Secondary|Duration of the Objective Response|Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.|Baseline to the end of the study (up to 4 years)|||||||
1230363|NCT00661778|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.|Baseline to the end of the study (up to 4 years)|Evaluable population: All participants who received at least 2 treatment cycles, have had all baseline lesions assessed on at least 1 occasion after receiving the 2nd treatment cycle, and have not had any major protocol violations.|||Percentage of participants|||Number
1230364|NCT00661778|Primary|Progression-free Survival|Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the end of the study (up to 4 years)|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.|||Months||95% Confidence Interval|Median
1230365|NCT00661726|Primary|Change in Total Hemoglobin (Hb) From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||g/dL||Standard Error|Mean
1230366|NCT00661726|Secondary|Change in Percentage of Annexin-positive Cells From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||% of Annexin-Positive Cells||Standard Error|Mean
1230367|NCT00661726|Secondary|Change in Percentage of Red Blood Cell (RBC) Hb Concentration From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||% of RBC Hb Concentration||Standard Error|Mean
1230368|NCT00661726|Secondary|Change in Red Blood Cell (RBC) Deformability From Baseline to Peak (the Follow-up Time Point With the Highest Value)|Deformability was assessed by ektacytometry. Normal RBC have maximal deformability, measurable by osmotic ektacytometry, at isotonicity (290 mosmol). A decrease on the Deformability Index (measured in arbitrary units) corresponds to an impairment in the cell membrane’s ability to alter its shape under stress.|up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||Arbitrary Units||Standard Error|Mean
1230369|NCT00661726|Secondary|Change in Neutrophil Counts From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||X (10^9)/L||Standard Error|Mean
1230370|NCT00661726|Secondary|Change in Platelet Count From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||X (10^9)/L||Standard Error|Mean
1230371|NCT00661726|Secondary|Change in Erythropoietin Levels From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||mIU/mL||Standard Error|Mean
1230372|NCT00661726|Secondary|Change in Absolute Reticulocyte Count From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||X (10^9)/L||Standard Error|Mean
1230373|NCT00661726|Secondary|Change in Serum Lactate Dehydrogenase (LDH) From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||U/L||Standard Error|Mean
1230374|NCT00661726|Secondary|Change in Indirect Bilirubin From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||µmol/L||Standard Error|Mean
1230375|NCT00661726|Primary|Number of Evaluable Patients With an Increase From Baseline in Hemoglobin (Hb) of ≥1.5 g/dL||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||participants|||Number
1230376|NCT00661726|Secondary|Change in Absolute Fetal Hemoglobin (HbF) From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||g/dL||Standard Error|Mean
1230377|NCT00661713|Secondary|Number of Subjects Reporting Unsolicited AEs Throughout the Study.|Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.|Throughout the study|Analysis was performed as per the safety dataset.|||participants|||Number
1230382|NCT00661713|Secondary|Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.|Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.|Month-1, month-2, month-3 and month-7|Analysis was performed as per the protocol dataset.|||percentage of Subjects||95% Confidence Interval|Number
1230383|NCT00661713|Secondary|Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.|at baseline, month-1, month-2, month-3, month-6 and month-7.|Analysis was performed as per the protocol dataset.|||percentage of Subjects||95% Confidence Interval|Number
1230384|NCT00661713|Secondary|Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.|Month-6 & 7|Analysis was performed as per the protocol dataset.|||percentage of Subjects||95% Confidence Interval|Number
1230385|NCT00661713|Primary|Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination|Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV|1 to 7 days after each vaccination|Analysis was performed as per the safety dataset.|||participants|||Number
1230386|NCT00661713|Primary|Percentages ‘of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.|Month-1, 2, 3|Analysis was performed as per the protocol dataset|||percentage of Subjects||95% Confidence Interval|Number
1230387|NCT00661687|Secondary|Lens Characteristics|Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.|Over all scheduled visits day 1 - 1 month|Over All Scheduled Visits, All Eligible, Dispensed Eyes|||Eyes|Participants||Number
1230388|NCT00661687|Secondary|LogMAR Visual Acuity|The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.|Mean over all visits - 1 day, 1 week, 1 month|All Eligible, Dispensed Eyes|||LogMAR|Participants|Standard Deviation|Mean
1230389|NCT00661687|Primary|Subjective Responses to Symptoms/Complaints|Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.|Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits|All eligible participants|||Visual Analogue Scale|Participants|Standard Deviation|Mean
1230390|NCT00661674|Secondary|SOWS Score|"The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. 15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.~The highest score possible (64) would indicate that the individual was experiencing every symptom of opioid withdrawal to the fullest extent possible while the lowest score (0) would indicate that the individual was not experiencing any symptoms of opioid withdrawal.~Mean post-naloxone SOWS scores (+/- SEM) were computed for pretreatment groups: Placebo, palonosetron, and palonosetron with hydroxyzine"|Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration)||||units on a scale (SOWS Scale)||Standard Error|Mean
1230391|NCT00661674|Primary|OOWS Score|"The OOWS is a 13-item instrument documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score possible = 13, minimum score possible = 0. T=15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.~OOWS scores at T=180 is the primary outcome measure of the study compared with baseline OOWS scores at T=-30 (30 minutes prior to study medication administration). Reported time frames are in relation to time past since administration of study medications.~Mean post-Naloxone OOWS scores (+/- SEM) were determined for pretreatment groups"|Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration)||||units on a scale (OOWS Scale)||Standard Error|Mean
1230392|NCT00661661|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.|Baseline up to Week 288|Safety analysis set: all participants who received at least 1 dose of study medication in current study.|||Particiants|||Number
1230393|NCT00661661|Secondary|Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement. Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study.|First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96|Participants who had completed Study A3921044 among all participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230457|NCT00661505|Secondary|Mean Change From Baseline in Ferritin at Week 16 and Week 24|Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||microgram/liter||Standard Deviation|Mean
1230394|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230395|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230396|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230397|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230398|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230399|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230400|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230401|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230402|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230403|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230404|NCT00661661|Secondary|Change From Baseline in Swollen Joint Counts|Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Swollen joints||Standard Error|Mean
1230405|NCT00661661|Secondary|Change From Baseline in Tender/Painful Joint Counts|This was carried out on 68 joints. Each joint’s response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Tender/painful joints||Standard Error|Mean
1230406|NCT00661661|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230407|NCT00661661|Secondary|Change From Baseline in Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230408|NCT00661661|Secondary|Change From Baseline in Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS)."|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230519|NCT00661141|Secondary|PK of Acetaldehyde: T1/2||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||hours||Standard Deviation|Mean
1230409|NCT00661661|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230410|NCT00661661|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230411|NCT00661661|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
1230412|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Percentage of participants|||Number
1230413|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Percentage of participants|||Number
1230414|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Percentage of participants|||Number
1230415|NCT00661622|Secondary|Systemic Progression Free Survival|"Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s)."|Baseline to time of progression||||months||95% Confidence Interval|Median
1230416|NCT00661622|Secondary|Median Progression Free Survival|"Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s)."|Baseline to time of progression||||months||95% Confidence Interval|Median
1230417|NCT00661622|Secondary|Overall Survival|Measured from the start of the treatment to death of patients|Baseline to death||||months||95% Confidence Interval|Median
1230583|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|2 years||||percentage of participants||95% Confidence Interval|Number
1230418|NCT00661622|Primary|Overall Response Rate|Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.|Baseline then 3 to 4 weeks after every 2 treatments||||percentage of participants||90% Confidence Interval|Number
1230419|NCT00661622|Primary|Response of Liver Metastases|"Complete response: Disappearance of all target and non-target liver lesions~Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions~Stable disease: Absence of change which would qualify as response or progression~Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s)"|Every 8 weeks||||participants|||Number
1230420|NCT00661609|Secondary|Overall Survival (OS)|Time in weeks from the first administration of study drug to death.|Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).|||Weeks||Full Range|Median
1230421|NCT00661609|Secondary|Progression Free Survival (PFS)|Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.|Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).|||Weeks||Full Range|Median
1230422|NCT00661609|Secondary|Duration of Objective Tumor Response (OTR)|Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)|Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)|||||||
1230423|NCT00661609|Secondary|Disease Control Rate (DCR)|Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).|8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).|||Percentage of participants|||Number
1230424|NCT00661609|Primary|Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)|Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).|8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).|||Percengate of participants|||Number
1230425|NCT00661583|Secondary|Mean Change in Visual Acuity|Mean change in visual acuity in logMAR.|6 months||||logMAR||Full Range|Mean
1230426|NCT00661583|Secondary|Mean Change in in Intraocular Pressure.|Mean change in in intraocular pressure at 3 months and at 6 months|6 months||||mmHg||Full Range|Mean
1230427|NCT00661583|Secondary|Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.|To determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications)|6 months||||percentage of subjects|||Number
1230428|NCT00661583|Primary|Assessment of Ocular Adverse Events|To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months|6 months||||Number of Reported Adverse Events|||Number
1230429|NCT00661570|Secondary|Reason for Replacement||At removal of prosthesis|1 patient had his Vega inappropriately removed and received a Provox2.|||patients|||Number
1230430|NCT00661570|Secondary|Ease of Insertion|The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.|assessed immediately after insertion procedure|All patients included for insertion evaluation|||insertions|||Number
1230431|NCT00661570|Secondary|Voice Quality|Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.|at 3 months or device change (whichever was first)|23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.|||Units on a scale||Standard Deviation|Mean
1230432|NCT00661570|Primary|Device Life Time|Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.|at replacement of voice prosthesis (maximum 1 year)|In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.|||days of use||Full Range|Median
1230584|NCT00660699|Post-Hoc|Incidence of Disease Recurrence||Median follow-up was 24 months (range 3.2-97 months)||||percentage of participants|||Number
1230585|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|1 year||||percentage of participants||95% Confidence Interval|Number
1230433|NCT00661557|Secondary|Number of Subjects With Any Specific Adverse Events|"Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease).~Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately."|Day 0 to study month 6|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1230434|NCT00661557|Secondary|Number of Subjects Reporting Any Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Day 0 to study month 6|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1230435|NCT00661557|Secondary|Number of Subjects With Unsolicited Symptoms|An unsolicited symptom covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|Up to one month post-vaccination (Month 1)|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1230436|NCT00661557|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0 to Day 3) period after vaccination|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included.|||Participants|||Count of Participants
1230437|NCT00661557|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 4-day (Day 0 to Day 3) period after vaccination|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included.|||Participants|||Count of Participants
1230438|NCT00661557|Secondary|Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y|"Vaccine response defined as:~For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer"|One month post-vaccination (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||Participants|||Count of Participants
1230439|NCT00661557|Secondary|Anti-tetanus Toxoid Antibody Concentrations|Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs).|Prior to (Day 0) and one month post-vaccination (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1230440|NCT00661557|Secondary|Anti-meningococcal Polysaccharide (PS) Antibody Concentrations|For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs).|Prior to (Day 0) and one month post-vaccination (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1230441|NCT00661557|Secondary|Meningococcal rSBA Titers|For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).|Prior to vaccination (Day 0)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
1230442|NCT00661557|Primary|Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers|For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).|One month post-vaccination (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
1230443|NCT00661544|Primary|Response Rate|Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.|3, 6 and 12 months||||Participants|||Number
1230444|NCT00661531|Secondary|Response Rate|Response rate was defined per RECIST version 1.0. In this study, response rate was defined as including patients with either a complete response (complete disappearance of all target lesions with changes confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met) or a partial response (at least 30% decrease in the sum of the longest diameter of the target lesions)|6 months||||Participants|||Count of Participants
1230445|NCT00661531|Primary|Progression Free Survival|Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause|6 months||||Participants|||Count of Participants
1230586|NCT00660699|Secondary|Overall Survival (OS) - Median|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.|Median follow-up was 24 months (range 3.2-97 months)||||months||95% Confidence Interval|Median
1230446|NCT00661505|Secondary|Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period|Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.|Week 1 to Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.|||Number of participants|||Number
1230447|NCT00661505|Secondary|Number of Participants With Reports of Anti-erythropoietin Antibodies|The number of participants with Anti-epoetin antibodies is presented.|Up to Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.|||Number of participants|||Number
1230448|NCT00661505|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 28|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.|||Number of participants|||Number
1230449|NCT00661505|Secondary|Number of Participants Taking Concomitant Medications|The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.|Up to Week 28|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.|||Number of participants|||Number
1230450|NCT00661505|Secondary|Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.|Baseline (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Millimeters of Mercury||Standard Deviation|Mean
1230451|NCT00661505|Secondary|Mean Change From Baseline in Weight at Week 16 and Week 24|Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||kilogram||Standard Deviation|Mean
1230452|NCT00661505|Secondary|Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24|Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||millimole/liter||Standard Deviation|Mean
1230453|NCT00661505|Secondary|Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24|Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||milligram/liter||Standard Deviation|Mean
1230454|NCT00661505|Secondary|Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24|Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Percentage of TSAT||Standard Deviation|Mean
1230455|NCT00661505|Secondary|Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24|Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||gram/liter||Standard Deviation|Mean
1230456|NCT00661505|Secondary|Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24|Mean change from BL in each parameter [iron, total iron binding capacity (TIBC), and creatinine] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||micromole/Liter||Standard Deviation|Mean
1230458|NCT00661505|Secondary|Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24|Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Number of cells x 10^9/L||Standard Deviation|Mean
1230459|NCT00661505|Secondary|Mean Change From Baseline in Hemoglobin at Week 16 and Week 24|Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||g/dL||Standard Deviation|Mean
1230460|NCT00661505|Secondary|Mean Change From Baseline in Hematocrit at Week 16 and Week 24|The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||percentage of red blood cells||Standard Deviation|Mean
1230461|NCT00661505|Secondary|Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24|Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Femtoliter||Standard Deviation|Mean
1230462|NCT00661505|Secondary|Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period|The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)|The ITT population included participants who received at least 1 dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||mcg||Standard Deviation|Mean
1230463|NCT00661505|Secondary|Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period|Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Percentage of participants|||Number
1230464|NCT00661505|Secondary|Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period|The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.|EEP (Week 16 to Week 20)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.|||mcg||Standard Deviation|Mean
1230465|NCT00661505|Secondary|Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period|The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.|EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.|||days||Inter-Quartile Range|Median
1230466|NCT00661505|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period|The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.|EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available.|||Percentage of participants||95% Confidence Interval|Number
1230467|NCT00661505|Secondary|Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period|The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.|SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)|The Intention to treat (ITT) population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.|||g/dL||Standard Deviation|Mean
1230468|NCT00661505|Primary|Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period|The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.|EEP (Week 16 to Week 24)|The per protocol (PP) population included all participants who received at least one dose C.E.R.A. and underwent a safety follow-up except who had < 3 recorded Hb values and had inadequate iron status during EEP, missed C.E.R.A administration during Weeks 16-24, and/or who withdrawn before the end of EEP.|||Percentage of participants||95% Confidence Interval|Number
1230469|NCT00661492|Secondary|Median Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|30 months|ITT population|||months||Full Range|Median
1230470|NCT00661492|Secondary|Median Progression-free Survival (PFS)|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|24 months|ITT population|||months||Full Range|Median
1230471|NCT00661492|Secondary|Prostate-specific Antigen (PSA) Doubling Time|PSA doubling time = [log (2)× t] ÷ [log (final PSA) - log (initial PSA)]|24 months|Evaluable Population with Prostate-specific antigen (PSA) Information|||months||Full Range|Median
1230472|NCT00661492|Secondary|Prostate-specific Antigen (PSA) Response Rate|Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later|24 months|Evaluable Population with Prostate-specific antigen (PSA) Information|||percentage of participants||95% Confidence Interval|Number
1230473|NCT00661492|Secondary|Median Time to Prostate-specific Antigen (PSA) Progression|Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression.|24 months|Patients with Prostate-specific antigen (PSA) Information|||Months||Full Range|Median
1230474|NCT00661492|Secondary|Objective Response Rate (ORR)|ORR = CR + PR Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|24 months|Patients with solid tumors|||percentage of participants||95% Confidence Interval|Number
1230475|NCT00661492|Secondary|2-year Radiographically Evident Progression-free Survival (REPFS).|"Radiographic progression:~1) For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture)."|24 months.|Patients who received bone scans or had bone progression only (bone pain/pathologic fracture/palliative radiation).|||Probability of REPFS at 2-year||95% Confidence Interval|Number
1230476|NCT00661492|Primary|Median Time to Progression (TTP)|TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.|24 months|ITT population|||Months||Full Range|Median
1230477|NCT00661479|Secondary|Change From Baseline in Contrast Sensitivity in the Study Eye|Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.|Baseline, Month 6|Safety Population: all patients treated on Day 1|||Number of Letters Read Correctly||Standard Deviation|Mean
1230478|NCT00661479|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 6|Safety Population: all patients treated on Day 1|||Number of Letters Read Correctly||Standard Deviation|Mean
1230479|NCT00661453|Secondary|Whole Body DEXA Scanning for Lean Body Mass and Total Bone Mineral Density/ Content||-2 weeks or time 0, 3 months, 6 months|||||||
1230480|NCT00661453|Secondary|Maximum Ulnar CMAP Amplitude/Area and MUNE||-2 weeks, time 0, 3 months, 6 months|||||||
1230481|NCT00661453|Secondary|Quantitative SMN mRNA and Protein Measures||-2 weeks, time 0 , 3 months, or 6 months|||||||
1230482|NCT00661453|Secondary|Functional Motor Assessments: TIMPSI Scores||-2 weeks, time 0, 3 months, 6 months|||||||
1230483|NCT00661453|Secondary|Primary Caregiver Functional Rating Scale for SMA Type I Subjects (PCFRS)||time 0, and monthly for 12 months|||||||
1230484|NCT00661453|Secondary|Time to Death or Ventilator Dependence (Defined as >16 Hours/Day)||monthly|||||||
1230485|NCT00661453|Primary|Anthropometric Measures of Nutritional Status (Body Mass Index [BMI] Z-scores, Weight for Length Ratios, Lean/Fat Mass Via DEXA, Growth Parameters, and Triceps Skinfold Measures)||-2 weeks, time 0, 3 months, 6 months|20 participants have baseline values, only 12 have 3 and 6 month values|||g||Standard Deviation|Mean
1230486|NCT00661453|Primary|Laboratory Safety Data||-2 weeks, + 2 weeks, 3 months, 6 months|||||||
1230487|NCT00661427|Secondary|The Total Number of Participants That Were Effected by Adverse Events.|Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity.|at least weekly||||Participants|||Count of Participants
1230488|NCT00661427|Primary|Number of Patients With Overall Objective Response|Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam|Approximately every 8 weeks with imaging up to two years||||participants|||Number
1230489|NCT00661388|Secondary|Mean Change From Baseline in Transferrin Saturation Over Time|Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Percentage of Transferrin Saturation||Standard Deviation|Mean
1230490|NCT00661388|Secondary|Mean Change From Baseline in Ferritin Concentration Over Time|Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||mcg/L||Standard Deviation|Mean
1230491|NCT00661388|Secondary|Mean Change From Baseline in Creatinine Concentration Over Time|Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 32, 40|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Micromole/L||Full Range|Median
1230492|NCT00661388|Secondary|Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time|Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Micromole /L||Standard Deviation|Mean
1230493|NCT00661388|Secondary|Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time|Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Millimoles /L||Standard Deviation|Mean
1230494|NCT00661388|Secondary|Mean Change From Baseline in C-Reactive Protein Concentration Over Time|Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Milligrams /L||Standard Deviation|Mean
1230495|NCT00661388|Secondary|Mean Change From Baseline in Albumin Concentration Over Time|Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||g/L||Standard Deviation|Mean
1230496|NCT00661388|Secondary|Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time|Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||10^9 cells/Liter (L)||Standard Deviation|Mean
1230497|NCT00661388|Secondary|Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time|Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Femtoliters||Standard Deviation|Mean
1230498|NCT00661388|Secondary|Mean Change From Baseline in Hematocrit Level Over Time|Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Fraction||Standard Deviation|Mean
1230499|NCT00661388|Secondary|Mean Change From Baseline in Hb Concentration Over Time|Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||g/dL||Standard Deviation|Mean
1230500|NCT00661388|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 52|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.|||Participants|||Number
1230501|NCT00661388|Secondary|Number of Participants Who Received Red Blood Cell Transfusions During the Study Period|Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP [Week 37 to Week 52]) are presented.|Up to Week 52|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants who entered a particular phase is determined by ‘n’.|||Number of participants|||Number
1230502|NCT00661388|Secondary|Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP|Percentage of participants requiring dose adjustments during dose titration period (DTP [Week 0 to Week 28]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or < 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|Weeks 0 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.|||Percentage of participants|||Number
1230503|NCT00661388|Secondary|Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP|Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.|||Days||Standard Deviation|Mean
1230504|NCT00661388|Secondary|The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP|The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up variable were included. Participants with less than three recorded Hb values during EEP; participants missing administration of C.E.R.A. during weeks 28-36; participants with inadequate iron status, were excluded.|||Percentage of participants||95% Confidence Interval|Number
1230505|NCT00661388|Secondary|Mean Time to Achievement of Response During the EEP|Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.|||Days||Standard Deviation|Mean
1230506|NCT00661388|Primary|Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period|Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP [Week 29 to Week 36]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.|From Baseline (Week 0) to EEP (Week 29 to Week 36)|Per protocol (PP) population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.|||g/dL||Standard Deviation|Mean
1230507|NCT00661362|Secondary|Proportion of Patients Achieving a Therapeutic Glycemic Response|Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.|||Percentage of participants|||Number
1230508|NCT00661362|Secondary|Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.|||mg*min/dL||Standard Error|Mean
1230509|NCT00661362|Secondary|Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.|||mmol*min/L||Standard Error|Mean
1230510|NCT00661362|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement|||mg/dL||Standard Error|Mean
1230511|NCT00661362|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement|||mmol/L||Standard Error|Mean
1230512|NCT00661362|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.|||percent||Standard Error|Mean
1230513|NCT00661271|Secondary|Quality of Life|Life satisfaction was measured with the HIV Quality of Life (QOL) measure, which included three subscales: life satisfaction (range: 1-5), illness burden (range: 1-5) and illness anxiety (range: 1-5). For life satisfaction, higher scores indicated higher satisfaction, and for the other two subscales greater scores indicated more issues with illness burden and illness anxiety.|assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported||||units on a scale||Standard Deviation|Mean
1230514|NCT00661271|Primary|Mindful Attention and Awareness Scale (MAAS)|"Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness~Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism~Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior"|assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported||||units on a scale||Standard Deviation|Mean
1230515|NCT00661258|Primary|Mean Adherence, as Measured by Electronic Drug Monitors (EDM)|We used the electronic drug monitors (EDM) adherence metric that was found to be most strongly associated with viral suppression (HIV RNA <400 copies/ml) in analysis of the pre-intervention data, EDM ‘proportion taken within dose time’ (see Gill et al, 2009). This measure estimated monthly adherence as the proportion of prescribed doses taken on time, e.g., within 1 hour of scheduled dose time ([number of doses taken ±1 hour of dose time] / [total number of prescribed doses]).|Month 12 (last month of 6-month intervention period) and 6-month post-intervention period|Of 68 subjects randomized at 6 months, 64 completed the full 12 months of data collection, 31 in Intervention Arm and 33 in Comparison Arm.|||percentage of doses taken on time||Standard Deviation|Mean
1230516|NCT00661258|Secondary|Change in CD4 Count|Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)|Month 6, Month 12||||cells/µL||Standard Deviation|Mean
1230517|NCT00661193|Secondary|Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|From date of registration to 3 years or death, whichever comes first|Although 33 patients were eligible for Erlotinib Hydrochloride, only 32 were evaluable for response due to one patient not having measurable disease at baseline.|||participants|||Number
1230518|NCT00661193|Primary|Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months||From date of registration to 3 years or death, whichever comes first||||months||95% Confidence Interval|Median
1230520|NCT00661141|Secondary|PK of Acetaldehyde: AUC%Extrap||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||percentage||Standard Deviation|Mean
1230521|NCT00661141|Secondary|PK of Acetaldehyde: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM*hr/mg||Standard Deviation|Mean
1230522|NCT00661141|Secondary|PK of Acetaldehyde: AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM*hr||Standard Deviation|Mean
1230523|NCT00661141|Secondary|PK of Acetaldehyde: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM*hr/mg||Standard Deviation|Mean
1230524|NCT00661141|Secondary|PK of Acetaldehyde: AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM*hr||Standard Deviation|Mean
1230525|NCT00661141|Secondary|PK of Acetaldehyde: Tmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||hours||Full Range|Median
1230526|NCT00661141|Secondary|PK of Acetaldehyde: DN Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM/mg||Standard Deviation|Mean
1230527|NCT00661141|Secondary|PK of Acetaldehyde: Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM||Standard Deviation|Mean
1230528|NCT00661141|Secondary|PK of Ethanol: Vz/F||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||dL||Standard Deviation|Mean
1230529|NCT00661141|Secondary|PK of Ethanol: CL/F||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||dL/hr||Standard Deviation|Mean
1230530|NCT00661141|Secondary|PK of Ethanol: T1/2||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||hours||Standard Deviation|Mean
1230531|NCT00661141|Secondary|PK of Ethanol: AUC%Extrap||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||percentage||Standard Deviation|Mean
1230532|NCT00661141|Secondary|PK of Ethanol: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||(mg*hr/dL)/mg||Standard Deviation|Mean
1230533|NCT00661141|Secondary|PK of Ethanol: AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||mg*hr/mL||Standard Deviation|Mean
1230534|NCT00661141|Secondary|PK of Ethanol: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||(mg*hr/dL)/mg||Standard Deviation|Mean
1230535|NCT00661141|Secondary|PK of Ethanol: AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||mg*hr/dL||Standard Deviation|Mean
1230536|NCT00661141|Secondary|PK of Ethanol: Tmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||hours||Full Range|Median
1230537|NCT00661141|Secondary|PK of Ethanol: DN Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||(mg/dL)/mg||Standard Deviation|Mean
1230538|NCT00661141|Secondary|PK of Ethanol: Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||mg/dL||Standard Deviation|Mean
1230539|NCT00661141|Secondary|PK of 4-MP: Apparent Volume of Distribution During Terminal Phase (Vz/F)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||Liters||Standard Deviation|Mean
1230540|NCT00661141|Secondary|PK of 4-MP: Apparent Clearance (CL/F)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||L/hr||Standard Deviation|Mean
1230541|NCT00661141|Secondary|PK of 4-MP: Half-Life (T1/2)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||hours||Standard Deviation|Mean
1230542|NCT00661141|Secondary|PK of 4-MP: Percentage of AUC0–∞ Obtained by Extrapolation (AUC%Extrap)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||percentage||Standard Deviation|Mean
1230543|NCT00661141|Secondary|PK of 4-MP: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||(ng*hr/mL)/mg||Standard Deviation|Mean
1230544|NCT00661141|Secondary|PK of 4-MP: AUC, From Time 0 Extrapolated to Infinite Time (AUC[0-∞])||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||ng*hr/mL||Standard Deviation|Mean
1230545|NCT00661141|Secondary|PK of 4-MP: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||(ng*hr/mL)/mg||Standard Deviation|Mean
1230546|NCT00661141|Secondary|PK of 4-MP: Area Under the Plasma Concentration-Time Curve (AUC), Calculated to the Last Measured Concentration (AUC[0-t])||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||ng*hr/mL||Standard Deviation|Mean
1230547|NCT00661141|Secondary|PK of 4-MP: Time to Cmax (Tmax)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||hours||Full Range|Median
1230548|NCT00661141|Secondary|PK of 4-MP: Dose-Normalized (DN) Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment||||(ng/mL)/mg||Standard Deviation|Mean
1230549|NCT00661141|Secondary|Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||ng/mL||Standard Deviation|Mean
1230550|NCT00661141|Primary|Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation|AEs were collected to evaluate the safety and tolerability of oral Antizol with concomitant ethanol administration in particitpants with symptoms of acetaldehyde toxicity associated with altered ethanol metabolism. AE: any untoward medical event that occurs following the first administration of study medication until the study participant’s last study visit, whether or not the event is considered drug related. SAE: an event that meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of an exposed subject; is medically significant or an important medical event as assessed by investigator or sponsor; is, in the opinion of the investigator, an important medical event.|Study Day 0 through Study Visit Day 7||||Participants|||Count of Participants
1230551|NCT00661089|Primary|Change in Pain Rating From Baseline to Four Weeks|Change scores from patient ratings VAS on mm scale for worst pain, averaged over a week for ratings performed at baseline and week four. Scale range 0-100 mm. 0= No pain, 100= worst pain|baseline and four weeks||||units on a scale 0-100mm||Inter-Quartile Range|Median
1230552|NCT00661089|Secondary|Ability to Perform Hygiene Rating||2,4,12, and 16 weeks|||||||
1230553|NCT00661089|Secondary|Time to Don a Pull Over Shirt||2,4,12, and 16 weeks|||||||
1230554|NCT00661089|Secondary|Change in Disability Assessment Scale for Hygiene|Subject rating of scores on the Disability Assessment Scale Range 0-3, 0= no disability, 3= severe disability|baseline and 4 weeks post injection||||units on a scale from 0-3||Inter-Quartile Range|Median
1230555|NCT00661037|Secondary|Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up||2 years||||Participants|||Count of Participants
1230556|NCT00661037|Secondary|Severe Intra-operative Complications|including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death|Acute (ICD implant)||||Participants|||Count of Participants
1230557|NCT00661037|Primary|Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up|"Severe implant-related* complications at ICD implants among the following:~Survival from cardiopulmonary arrest due to VF requiring 3 or more consecutive external shocks for termination or due to electro-mechanical dissociation.~Transient ischemic attack or stroke,~Cardiogenic shock,~Pulmonary edema,~Embolic events,~Anoxic coma~Pericardial tamponade~Death.~Events at follow up:~Sudden cardiac death (defined as witnessed unexpected death occurring <1 hour from symptoms onset or unwitnessed during sleep)~Resuscitation after ineffective documented appropriate ICD shocks~Implant related events are considered as those listed above, occurring during the implant procedure in the timeframe betweend device poket insertion and patient exit from the cath-lab, as well as those events occurring after the patient exit from the cath-lab that, after review from the event adjudication committee, have been classified as related to the implant procedure."|2 years||||Participants|||Count of Participants
1230558|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)||||ng*h/mL||Standard Deviation|Mean
1230559|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)||||ng*h/mL||Standard Deviation|Mean
1230560|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24 hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)||||ng*h/mL||Standard Deviation|Mean
1230561|NCT00660985|Primary|Tmax (hr) at Day 30|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 20 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 30.|||hours||Standard Deviation|Mean
1230562|NCT00660985|Primary|Tmax (hr) at Day 15|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 23 subjects in the Differin Gel 0.3% and 7 subjects in the Differin Gel 0.1% were detectable at Day 15.|||hours||Standard Deviation|Mean
1230563|NCT00660985|Primary|Tmax (hr) at Day 1|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 14 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 1.|||hours||Standard Deviation|Mean
1230564|NCT00660985|Primary|Cmax (ng/mL) at Day 30|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose)||||ng/mL||Standard Deviation|Mean
1230565|NCT00660985|Primary|Cmax (ng/mL) at Day 15|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)||||ng/mL||Standard Deviation|Mean
1230566|NCT00660985|Primary|Cmax (ng/mL) at Day 1|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)||||ng/mL||Standard Deviation|Mean
1230567|NCT00660907|Secondary|Proportion of Participants With Body Weight Reduction of at Least 5%|To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1230568|NCT00660907|Secondary|Proportion of Participants With at Least One Episode of Hypoglycemia|To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.|Baseline to Week 52|Full analysis set|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1230569|NCT00660907|Secondary|Adjusted Mean Change in Body Weight|To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
1230570|NCT00660907|Primary|Adjusted Mean Change in HbA1c Levels|To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values|||percent||95% Confidence Interval|Least Squares Mean
1230571|NCT00660829|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 Days||||Participants|||Number
1230572|NCT00660829|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Scores for a series of subscales are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days|ITT|||Units on a scale||Standard Deviation|Least Squares Mean
1230573|NCT00660829|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"Reflective secondary complex symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14-days||||Scores on a scale||Standard Deviation|Least Squares Mean
1230574|NCT00660829|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14-days|ITT|||Scores on a scale||Standard Deviation|Least Squares Mean
1230575|NCT00660829|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous (tNSS) consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days||||Scores on a scale||Standard Error|Least Squares Mean
1230576|NCT00660829|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14 days|ITT|||Scores on a scale||Standard Deviation|Least Squares Mean
1230577|NCT00660816|Secondary|Disease Stabilization Rate (e.g., Complete Response, Partial Response, and Stable Disease)|Estimated based on number of evaluable patients with complete response, partial response or stable disease|36 months after enrollment of last patient|Patients with a complete response, partial response, stable disease, or progressive disease|||participants|||Number
1230578|NCT00660816|Secondary|Response Rate|Estimated based on the number of responses by excluding the dropouts who are not evaluable for response using a binomial distribution|36 months after enrollment of last evaluable patient|Patients with a complete response, partial response, stable disease, or progressive disease|||participants|||Number
1230579|NCT00660816|Secondary|Overall Survival|Measured from the date of randomization to the date of death, whichever occurs first and censored at the date of last followed for those survivors|36 months after enrollment of last patient||||Months||95% Confidence Interval|Median
1230580|NCT00660816|Primary|Progression-free Survival|From the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.|18 months after enrollment of last patient||||Months||95% Confidence Interval|Median
1230581|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|1 year|30 out of 48 participants completed all components of study treatment.|||percentage of participants||95% Confidence Interval|Number
1230582|NCT00660699|Secondary|Overall Survival (OS) - Median|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.|Median follow-up was 24 months (range 3.2-97 months)|30 out of 48 participants completed all components of study treatment.|||months||95% Confidence Interval|Median
1230589|NCT00660699|Secondary|Toxicities Associated With Treatment (Grade 3-4)|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.|30 days after completion of treatment (treatment lasts approximately 19 weeks)||||percentage of participants|||Number
1230590|NCT00660699|Secondary|Toxicities Associated With Treatment (Grade 1-2)|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.|30 days after completion of treatment (treatment lasts approximately 19 weeks)||||percentage of participants|||Number
1230591|NCT00660699|Primary|Incidence of Severe Toxicities|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0|1 month after completion of treatment (treatment lasts approximately 19 weeks)||||percentage of participants|||Number
1230592|NCT00660660|Secondary|Monetary Value of Work Hours Saved|The monetary value of the work hours saved was derived from questions 2,4, and 5 of the WPAI and a standard hourly compensation rate reported by the US Bureau of Labor Statistics (US$28.48 as of June 2008).|Week 4|Results based on MITT population with available data for this outcome measure.|||Monetary value (US dollars)||Standard Deviation|Least Squares Mean
1230593|NCT00660660|Secondary|Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)|To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, “no difficulty” to 3, “severe difficulty.” Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.|Baseline and 4 weeks||||Percentage||Standard Deviation|Mean
1230594|NCT00660660|Secondary|Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)|Equivalent number of work hours missed was derived from questions 2, 4 and 5 of the Work Productivity and Activity Impairment Questionnaire: Sleep Disturbance-GERD (Gastroesophageal Reflux Disease) and summed up with the percent work impairment during the remaining hours that were actually worked.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage||Standard Deviation|Mean
1230595|NCT00660660|Secondary|Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)|Degree of sleep disturbance affecting work productivity. 100% is considered to be the worst outcome where there is no ability to work. 0% is considered to be the best outcome, no impairment.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage||Standard Deviation|Mean
1230596|NCT00660660|Secondary|Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)||4 weeks|Results based on MITT population with available data for this outcome measure.|||Work hours||Standard Deviation|Mean
1230597|NCT00660660|Secondary|Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.|Number of patients with 24-hour heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230598|NCT00660660|Secondary|Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study|Number of patients with daytime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21-28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230599|NCT00660660|Secondary|Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study|Number and percentage of patients with nighttime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230600|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230601|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230602|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230711|NCT00660023|Secondary|Number of Blood Transfusions During the DTP and EEP|The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.|||blood transfusions|||Number
1230603|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230604|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230605|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230606|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230607|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230608|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230609|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230610|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230611|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Results based on MITT population with available data for this outcome measure. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response.'"|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230612|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230613|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230614|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230639|NCT00660595|Secondary|Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)|PANSS score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS consists of 7 positive and 11 negative items each with associated descriptors. Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).|baseline and 3 weeks||||units on a scale|||Number
1230615|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230616|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230617|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230618|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230619|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230620|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230621|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230622|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230623|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 1 week of treatment. Results based on MITT population with available data for this outcome measure. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week||||Percentage of participants|||Number
1230624|NCT00660660|Secondary|Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Days to complete resolution of sleep disturbance. Days to complete resolution of sleep disturbances associated with GERD was defined as the number of days until the first day of the first 7‑consecutive-day period during which the patient’s daily diary response was “No” (did not have trouble sleeping due to GERD symptoms).'|4 weeks|Results based on MITT population with available data for this outcome measure.|||Days||Full Range|Median
1230625|NCT00660660|Secondary|Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|4 weeks||||Days||Full Range|Median
1230626|NCT00660660|Secondary|Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days, and ‘days to first relief’ was defined as the first day of the 7 days that reached relief of sleep disturbance.|4 weeks|Results based on MITT population with available data for this outcome measure.|||Days||Full Range|Median
1230627|NCT00660660|Secondary|Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD)as measured by: Percent of days without sleep disturbances after 4 weeks of treatment. Each morning of the study, patients registered their answer “Yes” or “No” to the question, “Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?” in the diary card.'|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of days||Standard Deviation|Mean
1230628|NCT00660660|Secondary|Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of Participants|||Number
1230629|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
1230630|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
1230631|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
1230632|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Complete resolution of sleep disturbances on the patient's last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
1230633|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?”. Complete resolution of Gastroesophageal Reflux Disease (GERD)-related sleep disturbances was defined as a daily diary response of “No” on 7 consecutive days during 4 weeks of treatment.|4 weeks||||Participants|||Number
1230634|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of “No” on 14 consecutive days.|2 weeks||||Participants|||Number
1230635|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of “No” on 7 consecutive days.|1 week||||Participants|||Number
1230636|NCT00660660|Secondary|Achievement of Developer-defined Good Sleep|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with ‎Gastroesophageal reflux disease (GERD), as measured by achievement of (yes/no) developer-defined good sleep (global Pittsburgh Sleep Quality Index - PSQI score ≤5) at Week 4.|4 weeks|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
1230637|NCT00660660|Secondary|Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline|To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, “no difficulty” to 3, “severe difficulty.” Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.|||Scores on a scale||Standard Deviation|Least Squares Mean
1230638|NCT00660660|Primary|Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.|Relief of nighttime heartburn on patient’s last 7 days in the study. Relief was defined as a daily diary card response of “none” or 0, on at least 6 of 7 days, allowing for one “mild” or 1 response. Diary card scale (none, mild, moderate, severe).|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
1230640|NCT00660595|Secondary|Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)|The Overt Agression Scale (OAS) change was to be measured by calculating the difference between baseline score and 3 week's score. Score between 1 and 16 verbal aggression (OAS 1, score 1-4), physical aggression against objects (OAS 2, score 5-8), physical aggression against self (OAS 3, score 9-11) and physical aggression against other people (OAS 4, score 12-16).|baseline and 3 weeks||||units on a scale|||Number
1230641|NCT00660595|Secondary|Change From Baseline in Clinical Global Impression, Severity Scale (CGI-S) and in Absolute Clinical Global Impression, Improvement Scale (CGI-I) (Performed 4 Times/ 3 Weeks)|The CGI change was to be measured by calculating the difference between baseline score and 3 week's score. CGI-S Score of 1 = no illness to score of 7 = extremely ill. CGI-I Score of 1 =very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment|baseline and 3 weeks||||units on a scale|||Number
1230642|NCT00660595|Primary|Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)|PANSS-EC score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS-EC consists of 5 items (Poor IMpulse Control, Tension, Hostility, Uncooperativeness, and Excitement), each with associated descriptors. Each descriptor is rated on a 7 point scale from 1 = (absence of any symptom) to 7 = (extremely severe symptoms).|baseline and 3 weeks||||units on a scale|||Number
1230643|NCT00660543|Primary|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).|Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.||||participants|||Number
1230644|NCT00660543|Primary|Mean Cerebral Blood Volume (CBV)|Radiographical progression is determined based on RANO criteria.|At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)|All patients with treated GMB showed apparent tumor progression on conventional MR images.|||mL/g||Standard Deviation|Mean
1230645|NCT00660517|Secondary|Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days|Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value.|day 1 to day 14|Intent to Treat(ITT) population (18 years of age or older) who have had at least one post baseline efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
1230646|NCT00660517|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in the 12 hour instantaneous total nasal symptoms score(iTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value."|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
1230647|NCT00660517|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|change from baseline in the 12 hour reflective total nasal symptoms score(rTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.|day 1 to day14|Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation|||units on a scale||Standard Deviation|Least Squares Mean
1230648|NCT00660504|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|participants were followed for the duration of the study, an average of 12 weeks||||percentage of participants|||Number
1230649|NCT00660504|Secondary|Progression-Free Survival||1.5 years after last subject enrolled||||month||95% Confidence Interval|Median
1230650|NCT00660504|Other Pre-specified|Overall Survival at 6 and 12 Months||6 and 12 months.||||percentage of patients||95% Confidence Interval|Number
1230651|NCT00660504|Primary|Overall Survival||1.5 years after last subject enrolled||||month||95% Confidence Interval|Median
1230652|NCT00660400|Secondary|Percentage of Participants With Overall Survival (OS)|Overall survival for all participants at one year after first dose of 5-azacitidine (Vidaza). Overall survival was calculated by the method of Kaplan-Meier with standard errors computed using Greenwood's formula.|One year|Participants who proceeded to allogeneic HCT|||percentage of participants||95% Confidence Interval|Number
1230653|NCT00660400|Secondary|Percentage of Participants Who Proceed to Hematopoietic Cell Transplantation (HCT)|Proportion of patients enrolled who subsequently proceeded to allogeneic HCT.|Up to 3 years|All participants|||percentage of participants|||Number
1230654|NCT00660400|Secondary|Overall Response Rate (ORR)|Pre-allogeneic HCT responses to 5-azacitidine (Vidaza), based on the International Working Group criteria: Complete Remission (CR); Partial Response (PR); Stable Disease (SD). Point estimates and 95% confidence intervals were calculated for the response rate to 5-azacitidine, evaluated at marrow evaluation after 4 cycles of 5-azacitidine or prior to HCT whichever came first. CR: Bone marrow with 5% myeloblasts and normal maturation of all cell lines. PR: All CR criteria if abnormal before treatment except bone marrow blasts decreased by 50% over pretreatment but still > 5%. SD: Failure to attain CR, PR, relapsed (or progressive) disease.|At the end of up to six (28 day) cycles of 5-azacitidine|Participants who proceeded to allogeneic HCT|||percentage of participants|||Number
1230655|NCT00660400|Primary|Percentage of Participants With Relapse-free Survival (RFS)|Relapse-free survival one year after allogeneic HCT in MDS patients receiving at least one complete cycle of 5-azacitidine (Vidaza) in the pre-transplantation setting. Relapsed disease: if with complete remission (CR) - greater than 5% blasts in bone marrow; if with partial response (PR) - greater than 30% increase in blasts in the marrow; if with stable disease (SD) - return to pretreatment peripheral blood levels and transfusion requirements due to disease.|One year post allogeneic HCT|Participants who proceeded to allogeneic HCT|||percentage of participants||95% Confidence Interval|Number
1234080|NCT00628251|Secondary|Best Percentage Change From Baseline in CA-125 Levels|Best percentage change in cancer antigen 125 (CA-125) levels|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Percent change||Full Range|Median
1230656|NCT00660387|Secondary|Employment Impairment (EMP) II Status at Week 12|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.|Week 12 (or early termination)|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.|||participants|||Number
1230657|NCT00660387|Secondary|Employment Impairment (EMP) I Status at Baseline|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).|Baseline|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.|||participants|||Number
1230658|NCT00660387|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12|The EQ VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230659|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230660|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV was totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.|||units on a scale||Standard Error|Least Squares Mean
1230661|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230662|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.|||units on a scale||Standard Error|Least Squares Mean
1230663|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230664|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230688|NCT00660309|Secondary|Change From Single Dose Peak to Steady State Peak in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) was calculated as Day 15 peak - Day 2 peak GFR. Peak GFR was obtained using a moving average concept."|Day 2 and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
1230665|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230666|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230667|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230668|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230669|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230670|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230671|NCT00660387|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230712|NCT00660023|Secondary|Number of Participants Receiving Blood Transfusion During the DTP and EEP|The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.|||participants|||Number
1230672|NCT00660387|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230673|NCT00660387|Secondary|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230674|NCT00660387|Secondary|Change From Baseline in UPDRS Part III Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230675|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230676|NCT00660387|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1230677|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1230678|NCT00660387|Secondary|"Change From Baseline in Average Daily Normalized On Time Without Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as On time without dyskinesia and On time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Error|Least Squares Mean
1230679|NCT00660387|Primary|"Change From Baseline to Week 12 in Average Daily Normalized Off Time"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Error|Least Squares Mean
1230689|NCT00660309|Secondary|Change From Baseline to Steady State Peak in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~This maximum multiple dose effect (MDE_Max) was calculated as Day 15 peak - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
1230680|NCT00660348|Primary|Number of Subjects Per Arm With Decrease in Pain Scores|The primary objective of this study is to compare the effectiveness of pain control between intrathecal opioid delivery and standard analgesia delivery method in patients with locally advanced unresectable or metastatic pancreatic cancer. The primary end point is the number of subjects on each arm showing a decrease in the change in VAS self-assessment pain intensity rating (VAS pain rating) at one month from initial treatment with respect to the baseline pain score. The change is defined as (the Pain Score at one month of the treatment - the Pain Score at baseline). Serial pain scores will be collected at all assessment time points. Min: zero cm. Max 10cm. A higher value means worse pain. Subjects on each arm will report pain on a 10 cm Visual Analogue Scale (VAS) pain rating scale, by making a mark on the 10cm horizontal line with a pen and study team will measure distance from the mark to the start of the scale, which will indicate pain score (eg 1 cm, 3 cm 6 cm, etc.).|1 month|One subject was enrolled, and baseline pain score was obtained on questionnaire, but the subject came off-study before follow-up pain score could be collected. Study terminated shortly thereafter. No outcome data were collected.||||||
1230681|NCT00660309|Secondary|Change From Baseline in Retinal Blood Flow After Aliskiren or Irbesartan|"Retinal blood flow was assessed using the laser Doppler technique. The blood flow in the superior temporal retinal artery in one of the eyes of each study participant was determined.~The Single dose effect of aliskiren or irbesartan was measured as the change/difference between Day 2 and baseline measurements.~The Multiple dose effect of aliskiren or irbesartan wsas measured as the change/difference between Day 15 and Day 2 measurements"|Baseline (Day 1), Day 2 and Day 15.|PD analysis set. This assessment was only conducted at sites with available Canon Laser Blood Flowmeter. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||µL/min||Standard Deviation|Mean
1230682|NCT00660309|Secondary|Change in Serum Aldosterone After Captopril, Aliskiren or Irbesartan|"The following serum aldosterone effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
1230683|NCT00660309|Secondary|Change in Plasma Angiotensin II After Captopril, Aliskiren or Irbesartan|"The following angiotensin II effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
1230684|NCT00660309|Secondary|Change in Plasma Angiotensin I After Captopril, Aliskiren or Irbesartan|"The following angiotensin I effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
1230685|NCT00660309|Secondary|Change in Plasma Renin Activity (PRA) After Captopril, Aliskiren or Irbesartan|"PRA was measured by the trapping method and the following effects assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 baseline / Day 2 baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
1230686|NCT00660309|Secondary|Change in Plasma Pro-renin Concentration After Captopril, Aliskiren or Irbesartan|"The following plasma pro-renin concentration effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
1230687|NCT00660309|Secondary|Change in Plasma Renin Concentration (PRC) After Captopril, Aliskiren or Irbesartan|"The following plasma renin concentration effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
1230690|NCT00660309|Secondary|Change From Baseline to Steady State Trough in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~This multiple dose effect at steady state (MDE_SS) was calculated as Day 15 baseline - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values."|Day 2 and Day 15 at Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) .|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
1230691|NCT00660309|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) After a Single Dose of Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
1230692|NCT00660309|Primary|Change From Single Dose Peak to Steady State Peak in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) was calculated as Day 15 peak – Day 2 peak. Peak RPF was obtained using a moving average concept."|Day 2 and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
1230693|NCT00660309|Primary|Change From Baseline to Steady State Peak in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~This maximum multiple dose effect (MDE_Max) was calculated as Day 15 peak – Day 2 baseline. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
1230694|NCT00660309|Primary|Change From Baseline to Steady State Trough in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~This multiple dose effect at steady state (MDE_SS) was calculated as Day 15 baseline – Day 2 baseline. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values."|Day 2 and Day 15 at Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) .|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
1230695|NCT00660309|Primary|Change From Baseline in Renal Plasma Flow (RPF) After a Single Dose of Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data.|||mL/min/1.73m^2||Standard Deviation|Mean
1230696|NCT00660309|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) After a Single Dose of Captopril|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~The measure of the single dose effect (SDE) for captopril was calculated as Day 1 peak - Day 1 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 1: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
1230697|NCT00660309|Secondary|Change From Baseline in Renal Plasma Flow (RPF) After a Single Dose of Captopril|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~The measure of the single dose effect (SDE) for captopril was calculated as Day 1 peak – Day 1 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 1: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data.|||mL/min/1.73m^2||Standard Deviation|Mean
1230698|NCT00660192|Secondary|Number of Participants Satisfied With Treatment|"Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment."|4 weeks||||participants|||Number
1230699|NCT00660192|Primary|Mean Number of Days of Decrease in Pain Level Using VAS|Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.|4 weeks||||days||Standard Deviation|Mean
1230700|NCT00660179|Other Pre-specified|Summary of the First Causes of Morbidity or Mortality|"Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).~Other worsening of PAH was defined by the combined occurrence of all the following 3 events:~At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.~AND worsening of PAH symptoms including at least one of the following:~a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy~AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics"|Up to end of treatment (Up to 36 months)|All randomized patients|||participants|||Number
1230701|NCT00660179|Secondary|Cardiac Index at Baseline and Month 6|In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.|Baseline to month 6|All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study|||L/min/m^2||Full Range|Mean
1230702|NCT00660179|Secondary|Pulmonary Vascular Resistance at Baseline and Month 6|In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.|Baseline to month 6|All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study|||(dyn*sec/cm^5)||Full Range|Mean
1230703|NCT00660179|Secondary|Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6|"Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope.~Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope.~Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope.~Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA."|Baseline to month 6|All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis|||participants|||Number
1230704|NCT00660179|Secondary|Change From Baseline to Month 6 in 6-minute Walk Distance|The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.|Baseline to month 6|All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis|||metres||Standard Deviation|Mean
1230705|NCT00660179|Secondary|Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)|Events of death due to any cause up to the end of study (EOS). The initiation of EOS procedure occurred when the target of 285 events was expected to have been achieved (30 January 2012).|Up to end of study (data presented up to month 36)|All randomized patients|||percentage of participants-Kaplan Meier|||Number
1230706|NCT00660179|Secondary|Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)|Events of death due to any cause up to the end of treatment (plus 7 days)|Up to end of treatment (data presented up to month 36)|All randomized patients|||percentage of participants-Kaplan Meier|||Number
1230707|NCT00660179|Secondary|Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)|Events of PAH or hospitalization for PAH up to the end of treatment included: death due to PAH, or onset of a treatment-emergent adverse event with a fatal outcome due to PAH occurring up to 4 weeks after the end of treatment, or hospitalisation for PAH up to the end of treatment.|Up to end of treatment (data presented up to month 36)|All randomized patients|||percentage of participants-Kaplan Meier|||Number
1230708|NCT00660179|Primary|Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)|"Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).~Other worsening of PAH was defined by the combined occurrence of all the following 3 events:~At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.~AND worsening of PAH symptoms including at least one of the following:~a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy~AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics"|Up to end of treatment (data presented up to month 36)|All randomized patients|||percentage of participants-Kaplan Meier|||Number
1230709|NCT00660075|Primary|Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)||At the end of the two 6-week interventions|We analyzed all the subjects involved in the study. The analysis was per protocol. We compared data from the placebo phase with the sitagliptin phase.|||mmol*h/L||Standard Deviation|Mean
1230710|NCT00660049|Primary|Ease of Use for Patients|Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.|Baseline up to 31 days|All participants|||participants|||Number
1230713|NCT00660023|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.|||percentage of participants|||Number
1230714|NCT00660023|Secondary|Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.|||mcg||Standard Deviation|Mean
1230715|NCT00660023|Secondary|Mean Time Spent in the Target Range for Hb During the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.|||days||Standard Deviation|Mean
1230716|NCT00660023|Secondary|Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1230717|NCT00660023|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.|||g/dL||Standard Deviation|Mean
1230718|NCT00660023|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Per Protocol (PP) Population: All participants from the ITT Population who fulfill inclusion/exclusion criteria per study protocol.|||percentage of participants||95% Confidence Interval|Number
1230719|NCT00660010|Primary|Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)|Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).|Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 6 males (genital development suppression). Study drug was discontinued at the initiation of puberty.|||Percentage of subjects|||Number
1230720|NCT00660010|Other Pre-specified|Number of Pregnancies Reported by Subjects at Final Questionnaire|The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.|||Pregnancies|||Number
1230721|NCT00660010|Other Pre-specified|Number of Subjects Who Reported Pregnancies at Final Questionnaire|The final questionnaire was completed by 20 females who were at least 18 years of age. The subjects reported on total number of pregnancies resulting in live births or number of miscarriages (spontaneous or elective) and whether the subject was currently pregnant.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.|||Subjects|||Number
1230741|NCT00659815|Primary|Comfort|Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.|Over-all follow-up visits from baseline to 1 month|Symptoms/Complaints Over-All Scheduled Follow-Up Visits (All Eligible, Dispensed Eyes with non-missing scores)|||Units on a Scale|Participants|Standard Deviation|Mean
1230742|NCT00659789|Secondary|Effects on Vacc-4x on HIV-1 RNA||Weeks 24,28,32,36,40,44,48,52.||||copies/mL||Standard Deviation|Mean
1230722|NCT00660010|Other Pre-specified|Number of Female Subjects Who Reported Regular Menses at Adulthood|Subjects were required to complete final adult questionnaire to provide information on adult reproductive function. Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.|||Subjects|||Number
1230723|NCT00660010|Other Pre-specified|Mean Time to or Mean Age at Regular Menses in Females After Treatment|Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment.|Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)|During the posttreatment period, data were obtained from 32 female subjects. Twenty-seven subjects reported the start of menses, but only 26 subjects reported a menses start date.|||years||Standard Deviation|Mean
1230724|NCT00660010|Other Pre-specified|Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)|Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity <1 cm/year or a bone age >14 yrs in females or >15 yrs in males.|Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males)|For the follow-up posttreatment period, the ITT population=40 subjects and the safety population=55 subjects who received at least 1 injection of study drug during the treatment period. Study drug was discontinued at the initiation of puberty. The mean age of subjects at final questionnaire completion was 24.76 years with a range of 18.87 to 26.66.|||cm||Standard Error|Mean
1230725|NCT00660010|Secondary|Mean Ratio of Bone Age to Chronological Age|Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age.|Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.|||ratio||Standard Deviation|Mean
1230726|NCT00660010|Secondary|Mean Stimulated Testosterone Concentrations in Males|Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|All males in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.|||ng/dL||Standard Deviation|Mean
1230727|NCT00660010|Secondary|Mean Stimulated Estradiol Concentrations in Females|Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|All females in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.|||pg/mL||Standard Error|Mean
1230728|NCT00660010|Secondary|Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations|Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females and 6 males. Study drug was discontinued at the initiation of puberty.|||mIU/mL||Standard Deviation|Mean
1230729|NCT00660010|Primary|Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)|Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).|Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females (breast development suppression). Study drug was discontinued at the initiation of puberty.|||Percentage of subjects|||Number
1230730|NCT00659984|Secondary|Quality of Life|Patients (aged 5-18) and parents (of patients aged 2-18) were asked to complete the 23-item Pediatric Quality of Life InventoryTM (PedsQLTM). PedsQLTM consists of 4 scales (physical, emotional, social, school functioning) which are then averaged into an overall summary score (scale: 0-100 with 0 representing the worst possible Quality of Life overall summary score and 100 representing the best possible Quality of Life overall summary score). The mean difference between the post treatment overall summary score and the baseline overall summary score is reported.|Day 60 +/- 10 days post Therapeutic Dose|Self reported PedsQL™ scores were obtained for 9 patients in the ITT population (n=15) at baseline (prior to the start of the Ultratrace™ Iobenguane I 131 imaging studies) and at the end of therapy (60 ±10 days post treatment).|||units on a scale||Standard Deviation|Mean
1230743|NCT00659789|Secondary|Time to Restart of ART for Vacc-4x Subjects Versus Placebo|Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)|Between Week 28 to Week 52|ITT Population|||days||Standard Deviation|Mean
1230744|NCT00659789|Secondary|Effect of Vacc-4x on CD8 Counts|CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52|Weeks 6,18,24,28,32,36,40,44,48,52.|Subject who stopped ART at week 28 and remained off ART until week 52|||cells/µL||Inter-Quartile Range|Median
1230731|NCT00659984|Secondary|Tumor Response in CT/MRI Lesions Post Therapeutic Treatment|Measurable disease was defined for a conventional CT scan by the presence of at least one lesion that could be accurately measured in at least one dimension with the longest diameter at least 20 mm by Independent Review. Efficacy success was defined as a patient achieving a Complete Response (CR)=disappearance of all target and non-target CT/MRI lesions; or, Very Good Partial Response (VGPR)=greater than 90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurement disease at study entry. Non-target CT/MRI lesions stable to smaller in size; or, Partial Response (PR)=at least 30% decrease in the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size.|Day 60 +/- 10 days post Therapeutic Dose|The evaluable population (which excludes non-evaluable responses) contains one patient less than the full ITT population.|||percentage of evaluable population||95% Confidence Interval|Number
1230732|NCT00659984|Secondary|Overall Objective Tumor Response Post Therapeutic Treatment|The International Neuroblastoma Response Criteria (INRC) were utilized as a basis for the overall response criteria, which incorporated responses in MIBG positive lesions,bone marrow disease, and CT/MRI lesions that met NANT-modified RECIST criteria. Efficacy success was defined as the proportion of pts who were successful overall [i.e., achieving a Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR)] determined by independent reviewers. CR = Disappearance of all target lesions, homovanillic acid/ vanillylmandelic acid (HVA/VMA) normal (NL); VGPR = > 90% decr of disease for CT/MRI target lesions, all pre-existing bone lesions with CR by MIBG; MIBG scan can be SD/CR in soft tissue lesions. CR in bone marrow, no new tumor sites, and NL HVA/VMA.; PR = At least 30% decr in disease measurement for CT/MRI target lesions. Bone marrow with CR, MIBG with either PR/CR in bone lesions, MIBG may be SD /CR in soft tissue lesions, and HVA/VMA may still be elevated.|Day 60 +/- 10 days post Therapeutic Dose|The evaluable population (which excludes non-evaluable responses) contains one patient less than the full ITT population.|||proportion of evaluable population||95% Confidence Interval|Number
1230733|NCT00659984|Secondary|Dosimetric Estimation of Radiation Absorbed Doses to Measurable Lesions|The dosimetric endpoint was to estimate radiation absorbed doses to measurable lesions and to a standard set of normal organs following an imaging dose of 0.1 mCi/kg Ultratrace™ Iobenguane I 131. Biodistribution was assessed by determination of total body residence (TBR) time and by visual examination of whole body camera images. 3 timepoints were used, the 1st image was taken within 1hr after the imaging dose, the 2nd image was taken at ~24hr after imaging dose, the 3rd image was taken 2-5d after imaging dose. Whole body radiation absorbed dose estimates & kidney, liver, and lung were calculated using the Medical Internal Radiation Dose (MIRD) schema.TBR time is derived from time integration of curve-fitted injected activity across all 3 timepoints when the isotope is emitting radiation.Three points are sampled to estimate a singular value for each organ and tissue according to the commonly used methods of the Society of Nuclear Medicine and Molecular Imaging Committee on MIRD.|Day 5 post Dosimetric Dose|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection).|||Gy||Standard Deviation|Mean
1230734|NCT00659984|Secondary|Dose Limiting Toxicities|Dose limiting toxicities include treatment emergent adverse events (TEAEs) that were possibly, probably, or definitely related to Ultratrace™ Iobenguane I 131.|From the time of signed informed consent until Day 60 or until the end of therapy evaluation is completed (whichever comes first).|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection) and all 15 patients later received a single therapeutic dose of Ultratrace™ Iobenguane I 131.|||number of DLTs|||Number
1230735|NCT00659984|Primary|Maximum Tolerated Dose|The maximum tolerated dose (MTD) was defined as the dose immediately below the level at which dose escalation would be stopped due to dose limiting toxicities (DLTs). Once the MTD was reached, an additional 3 patients were to be treated at that dose level, for a total of 6 patients at that planned dose level. DLTs were defined as any of the events that are possibly, probably or definitely attributable to UltratraceTM iobenguane I 131. The MTD was supposed to be the highest dose tested at which fewer than 1/3 of pts experience a DLT when 6 patients have been treated at the MTD but the dosimetry results indicated that the maximal dosage allowed to normal organs would be exceeded if the highest planned dose (21.0 mCi/kg) was administered, so the highest dose administered in the study was 18.6 mCi/kg .|Day 60 +/-10 or Engraftment, whichever comes first|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection) and all 15 patients later received a single therapeutic dose of Ultratrace™ Iobenguane I 131.|||mCi/kg|||Number
1230736|NCT00659945|Primary|Number of Participants Having Post-operative Emesis and Nausea.|Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups.|48 hours post surgery||||participants|||Number
1230737|NCT00659880|Secondary|MRI Assessments|"MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn.~Images were also assessed for oedema in each of these 3 regions of the meniscus."|12 months||||participants|||Number
1230738|NCT00659880|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS)|The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.|60 months||||units on a scale||Standard Deviation|Mean
1230739|NCT00659815|Primary|Lens Deposits|Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.|Over-all study visits, baseline to 1-month|Lens deposits over all scheduled follow-up visits (all eligible, dispensed eyes with non-missing data)|||Eyes|Participants||Number
1230740|NCT00659815|Primary|Slit Lamp Findings|Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.|Over-all follow-up visits from baseline to1 month|Graded Slit Lamp Findings over All Follow-Up Visits (Any finding, All Dispensed Eyes, 151 + 2 possible).|||Eyes|Participants||Number
1230745|NCT00659789|Secondary|Immunogenicity|Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema|Week 1, week 18 and week 52|ITT Population|||participants|||Number
1230746|NCT00659789|Secondary|Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths|Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.|Up to week 52|Safety Population|||participants|||Number
1230747|NCT00659789|Primary|Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.||From Week 28 to Week 52|ITT Population|||participants|||Number
1230748|NCT00659737|Primary|Number of Participants With Postoperative Nausea and Vomiting||0-24 hours||||participants|||Number
1230749|NCT00659724|Primary|Dialyzer Assessment: Venous Header Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows:~Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots."|Each treatment: the assessment of the condition of the venous header after rinse-back||||Number of Dialyzers|Dialyzers||Number
1230750|NCT00659724|Primary|Dialyzer Assessment: Arterial Header Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows:~Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots."|Each treatment: assessment of the condition of the arterial header after rinse-back||||Number of Dialyzers|Dialyzers||Number
1230751|NCT00659724|Primary|Dialyzer Assessment: Fiber Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows:~Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)"|Each treatment: assessment of the condition of the dialyzer fibers after rinse-back||||Number of Dialyzers|Dialyzers||Number
1230752|NCT00659724|Primary|Ease of Use: Priming Dialysate Side|"For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows:~Dialysate Side at 500 ml Priming Volume (check one):~Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air."|Priming at each treatment||||Number of Dialyzers|Dialyzers||Number
1230753|NCT00659724|Primary|Ease of Use: Priming Blood Side|"For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows:~Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air.~Very Difficult:Air could not be removed."|Priming at each treatment||||Number of Dialyzers|Dialyzers||Number
1230754|NCT00659633|Primary|Pain Perception|"Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer.~The mechanical slide algometer [Price et al. (1994)] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale."|Participants will be followed from baseline through 128 minutes||||units on a scale||Standard Error|Mean
1230755|NCT00659607|Secondary|Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile|"Efficacy rate by medical characteristic of patients~40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient’s BP control result, this range exists"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment and Daily dose not recorded for 26 patients|||Percentage of patients|||Number
1230756|NCT00659607|Secondary|Baseline Severity of Hypertension Factors Affecting the Efficacy Profile|"Efficacy rate by medical characteristic of patients~Stage 1 (SBP 140~159 mmHg or DBP 90~99 mmHg) Stage 2 (SBP 160~179 mmHg or DBP 100~109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||Percentage of patients|||Number
1230757|NCT00659607|Secondary|Previous Medication Factors Affecting the Efficacy Profile|Efficacy rate by medical characteristic of patients|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||Percentage of patients|||Number
1230758|NCT00659607|Secondary|Medical History Factors Affecting the Efficacy Profile|Efficacy rate by medical characteristic of patients|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||Percentage of patients|||Number
1230759|NCT00659607|Secondary|Concomitant Disease Factors Affecting the Safety Profile|Occurrence status of adverse events by Concomitant disease of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment|||Percentage of patients||95% Confidence Interval|Number
1230760|NCT00659607|Secondary|Medical History Factors Affecting the Safety Profile|Occurrence status of adverse events by medical history of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment|||Percentage of patients||95% Confidence Interval|Number
1230761|NCT00659607|Primary|Effective Rate|"Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows:~Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved)~Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||Percentage of patients|||Number
1230762|NCT00659607|Primary|Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2|Effect on decrease in diastolic blood pressure|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||mmHg||Standard Deviation|Mean
1230763|NCT00659607|Secondary|Treatment Type Factors Affecting the Safety Profile|Occurrence status of adverse events by Treatment type of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Treatment type not recorded for 294 patients|||Percentage of patients||95% Confidence Interval|Number
1235163|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.||Baseline to Month 3|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1230764|NCT00659607|Secondary|Proportion of Geriatric Population Factor Affecting the Safety Profile|Occurrence status of adverse events by Proportion of geriatric population of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients|||Percentage of patients||95% Confidence Interval|Number
1230765|NCT00659607|Secondary|Age Factors Affecting the Safety Profile|Occurrence status of adverse events by Age category of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients|||Percentage of patients||95% Confidence Interval|Number
1230766|NCT00659607|Secondary|Gender Factors Affecting the Safety Profile|Occurrence status of adverse events by Gender category of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Gender not recorded for 15 patients|||Percentage of patients||95% Confidence Interval|Number
1230767|NCT00659607|Primary|Change From Baseline in SBP (Systolic Blood Pressure) at Week 2|Effect on decrease in systolic blood pressure|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||mmHg||Standard Deviation|Mean
1230768|NCT00659607|Primary|Frequency of Adverse Events||Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment|||Percentage of patients|||Number
1230769|NCT00659607|Primary|Unexpected Adverse Events|Occurrence status of unexpected adverse events|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment|||Percentage of patients|||Number
1230770|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 36 Months||initiation and 36 months|The 8270 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 36 months were excluded.|||mmHg||Standard Deviation|Mean
1230771|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 36 Months||initiation and 36 months|The 8267 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 36 months were excluded.|||mmHg||Standard Deviation|Mean
1230772|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 24 Months||initiation and 24 months|The 6544 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 24 months were excluded.|||mmHg||Standard Deviation|Mean
1230773|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 24 Months||initiation and 24 months|The 6544 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 24 months were excluded.|||mmHg||Standard Deviation|Mean
1230774|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 12 Months||initiation and 12 months|The 4400 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 12 months were excluded.|||mmHg||Standard Deviation|Mean
1230775|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 12 Months||initiation and 12 months|The 4400 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 12 months were excluded.|||mmHg||Standard Deviation|Mean
1230776|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 6 Months||initiation and 6 months|The 2506 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 6 months were excluded.|||mmHg||Standard Deviation|Mean
1230777|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 6 Months||initiation and 6 months|The 2503 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 6 months were excluded.|||mmHg||Standard Deviation|Mean
1230778|NCT00659581|Primary|Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events||3 years after initiation of treatment|All of observed 20,443 patients were included as intention to treat set|||Number of participants|||Number
1230779|NCT00659529|Secondary|Serum Sildenafil Levels||Pre/during therapy|||||||
1230780|NCT00659529|Secondary|CFQ-R||Pre/post therapy|||||||
1230781|NCT00659529|Secondary|Exhaled Breath Condensate pH||Pre/post therapy|||||||
1230782|NCT00659529|Primary|Sputum Elastase||Pre/post therapy|Subjects who completed 6 weeks of sildenafil and had available data for pre/post 6 weeks of sildenafil were analyzed. One subject presented to the final study visit with 1 week of previously unreported symptoms consistent with pulmonary exacerbation, and therefore, efficacy data was not analyzed on that subject as pre-specified in the protocol.|||micrograms/mL||95% Confidence Interval|Mean
1230783|NCT00659490|Secondary|Time to Max Deterioration in VAMS Down|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||minutes||Standard Deviation|Mean
1230784|NCT00659490|Secondary|Time to Max Deterioration in VAMS Sedated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||minutes||Standard Deviation|Mean
1230809|NCT00659438|Secondary|Overall Survival (OS)|To investigate the effect of vandetanib on overall survival. Patients alive at the time of the statistical analysis were censored at the time they were last known to be alive. Due to censored data, median overall survival in the placebo group cannot be calculated. OS defined as the number of participants who were alive.|End of study (July 2011)||||participants|||Number
1230785|NCT00659490|Secondary|Time to Max Deterioration in VAMS Anxious|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||minutes||Standard Deviation|Mean
1230786|NCT00659490|Secondary|Time to Max Deterioration in VAMS High|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||minutes||Standard Deviation|Mean
1230787|NCT00659490|Secondary|Time to Max Deterioration in VAMS Stimulated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||Minutes||Standard Deviation|Mean
1230788|NCT00659490|Secondary|Maximum Deterioration in VAMS Down|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included. The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
1230789|NCT00659490|Secondary|Maximum Deterioration in VAMS Sedated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
1230790|NCT00659490|Secondary|Maximum Deterioration in VAMS Anxious|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
1230791|NCT00659490|Secondary|Maximum Deterioration in VAMS High|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
1230792|NCT00659490|Secondary|Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
1230793|NCT00659490|Secondary|Number of Patients Requesting Rescue Medication|Observed case.|End of surgery up to 8hours following surgery|The analyses are based on a per-protocol population.|||Participants|||Number
1230794|NCT00659490|Secondary|Time to First Intake of Rescue Medication.||From end of surgery to 8 hours following surgery|Only patients actually taking rescue medication are included in analysis.|||Hours||Standard Deviation|Mean
1230810|NCT00659438|Secondary|PSA Response Rate|"To investigate the effect of vandetanib on the PSA response rate. PSA response rate defined by the number of participants with a PSA decrease relative to baseline of at least 50%.~A minimum decrease of 2 ng/mL in absolute value and a confirmation on at least 2 consecutive occasions (at least 4 weeks apart) were requested."|4 months||||Participants|||Number
1230795|NCT00659490|Secondary|Pain at Jaw Movement at Time of First Rescue Medication|"Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case.~Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)."|At time of first rescue medication (before 8 hours after end on surgery)|Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
1230796|NCT00659490|Secondary|Pain at Rescue Medication|"Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case.~Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)."|At time of first rescue medication taken before 8 hours after end of surgery|Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
1230797|NCT00659490|Secondary|Mean Pain at Jaw Movement|Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ).|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.|||mm||Standard Deviation|Mean
1230798|NCT00659490|Secondary|Maximum Pain at Jaw Movement|"Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.~Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)"|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.|||mm||Standard Deviation|Mean
1230799|NCT00659490|Secondary|Pain at Jaw Movement AUC0-4h|Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable).|0-4h after end of surgery to 4 hours post surgery|The analyses based on a per-protocol pop.|||mm*h||Standard Deviation|Mean
1230800|NCT00659490|Secondary|Pain at Jaw Movement AUC0-8h|Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable)|0-8h from end of surgery to 8 hours post surgery|The analyses based on a per-protocol pop.|||mm*h||Standard Deviation|Mean
1230801|NCT00659490|Secondary|Mean Pain Based on a VAS Scale|Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.|||mm||Standard Deviation|Mean
1230802|NCT00659490|Secondary|Maximum Pain Based on VAS Scale|"Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.~Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)"|From end of surgery to 8h or time first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.|||mm||Standard Deviation|Mean
1230803|NCT00659490|Secondary|Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)|Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.|0-4h (from end of surgery to 4 hours post surgery)|The analyses based on a per-protocol population.|||mm*h||Standard Deviation|Mean
1230804|NCT00659490|Primary|Pain Area Under the Curve 0-8h (AUC0-8h)|Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.|0-8 h(from end of surgery to 8 hours post surgery)|The analyses based on a per-protocol population.|||mm*h||Standard Deviation|Mean
1230805|NCT00659438|Secondary|Number of Patients With CECs, CTCs and Gene Signature Profile of CTCs|"To investigate the relationship between response to vandetanib, CTCs and CECs. To investigate gene signature profile of antiangiogenic response by gene micro-array analysis of CTCs.~Gene signature profile of CTCs was aimed to be compared before and after 2 months of treatment. No blood sample has been taken for the study, and so results on CTCs, CECs of tumour vessels and gene and signature profiles of CTCs were not performed."|4 months|||||||
1230806|NCT00659438|Secondary|Number of Circulating Endothelial Cells (CEC) of Tumour Blood Cells (in Patients Included in Ile de France Centres Only)|"To investigate the effect of vandetanib on CEC. Numbering of CECs was to be performed at baseline, 1 week, 1 month and 2 months after randomisation.~Correlation between the number of CECs and PSA response was to be estimated after 1 week, 1 month and 2 months of treatment."|4 months|This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.||||||
1230807|NCT00659438|Secondary|Number of Circulating Tumour Cells (CTC) (in Patients Included in Ile de France Centres Only)|"To investigate the effect of vandetanib on CTC. Numbering of CTCs to be performed at baseline, 1 week, 1 and 2 months after randomisation. This study was proposed only to patients followed in a study centre located in Ile de France.~Correlation between the number of CTCs and PSA response was to be estimated after 1 week, 1 and 2 months of treatment"|4 months|This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.||||||
1230808|NCT00659438|Secondary|Progression Rate From the Radionuclide Bone Scanning|To describe the effect of vandetanib on progression rate from the radionuclide bone scanning in a sub-group of patients who had a bone scan within 3 to 6 months after 1st treatment dose. Number of participants with at least 2 new lesions on the radionuclide bone scan compared to baseline assessment were counted for calculation of progression rate.|4 months||||Participants|||Number
1230811|NCT00659438|Secondary|Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms)|Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to onset of cancer-related symptoms was not evaluated. PFS was evaluated instead, whether biological or clinical progression.|4 months||||weeks||95% Confidence Interval|Median
1230812|NCT00659438|Secondary|Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression)|Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to PSA progression was not evaluated. PFS was evaluated instead, whether biological or clinical progression.|4 months||||weeks||95% Confidence Interval|Median
1230813|NCT00659438|Primary|Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months|"To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set).~PSA progression free rate defined as the number of participants with :~After decline from baseline: a 25% increase above the nadir~No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)"|4 months||||Participants|||Number
1230814|NCT00659425|Secondary|Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)|Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||participants|||Number
1230815|NCT00659425|Secondary|CD22 Expression Cells in Peripheral Blood by Best Response|Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug. Here, n = participants evaluable for specified category for each arm, respectively|||sites per cell||Full Range|Median
1230816|NCT00659425|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody|Participants tested for immunogenicity to CAT-8015 (moxetumomab pasudotox) prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||Participants|||Number
1230817|NCT00659425|Primary|Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.|||hour (h)||Standard Deviation|Mean
1230818|NCT00659425|Primary|Systemic Clearance (CL) for Moxetumomab Pasudotox|The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma area under the plasma concentration-time curve from time zone to infinite time (AUC[0-infinity]).|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.|||milliliter per hour per kilogram||Standard Deviation|Mean
1230819|NCT00659425|Primary|Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox|The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.|||hour*nanogram per milliliter (h.ng/mL)||Standard Deviation|Mean
1230820|NCT00659425|Primary|Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox|The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1230821|NCT00659425|Primary|Overall Survival (OS)|Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."|||months||Full Range|Median
1230822|NCT00659425|Primary|Progression-Free Survival (PFS)|Progression-free survival was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression or death due to any cause, whichever occurs first. Number of progressions/deaths were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."|||months||Full Range|Median
1230882|NCT00658788|Secondary|Signs of Psoriasis - Erythema||2, 4, 8 and 12 weeks||||participants|||Number
1230883|NCT00658788|Secondary|Global Improvement Score||2, 4, 8 and 12 weeks||||participants|||Number
1230823|NCT00659425|Primary|Time to Disease Progression (TDP)|Time to disease progression was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression. Number of progressions were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."|||months||Full Range|Median
1230824|NCT00659425|Primary|Duration of Response (DR)|Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment|Evaluable Population for Efficacy. Here, “N” is number of participants with objective disease response in the respective cohort. DR could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).|||months||Full Range|Median
1230825|NCT00659425|Primary|Time to Disease Response|Time to disease response was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was assessed in participants who achieved objective response.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Evaluable Population for Efficacy. Here, “N” is number of participants with objective disease response in the respective cohort. Time to disease response could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).|||months||Full Range|Median
1230826|NCT00659425|Primary|Percentage of Participants With Relapse of Disease|Relapse is defined as progressive disease (PD) following complete response (CR). Rate of relapse was only calculated for the subgroup of participants with complete response.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Efficacy population. Here, “N” is number of participants with CR in the respective cohort. Rate of relapse could not be estimated as none of the participants experienced CR in the 5 mcg/kg, 20 mcg/kg (Schema A) and 30 mcg/kg (schema A) cohort of the study.|||percentage of participants|||Number
1230827|NCT00659425|Primary|Objective Response Rate (ORR)|Objective response based on assessment of confirmed composite complete response (CRc) or partial response (PR) according to disease specific criteria [modified criteria for response in acute lymphoblastic leukemia (ALL)].|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|"Efficacy population included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. Here, N is number of participants analyzed for this outcome measure."|||percentage of participants|||Number
1230828|NCT00659425|Primary|Best Overall Tumor Response|Antitumor activity was assessed by best overall tumor response.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."|||Participants|||Number
1230829|NCT00659425|Primary|Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate|The 12-lead ECG data were summarized and evaluated for the following parameters: ,QT, QTC intervals and ventricular rate. Change from baseline in these parameters were reported.|Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||milli seconds (msec)||Standard Deviation|Mean
1230830|NCT00659425|Primary|Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG|Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||participants|||Number
1230831|NCT00659425|Primary|Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline|Ophthalmologic examination included evaluation of retinal, corneal and lens abnormalities at baseline and end of treatment that were not present at screening. Participants who experienced abnormalitities during ophthalmologic examination recorded and reported.|Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||Participants|||Number
1230832|NCT00659425|Primary|Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants|An abnormal chemistry finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.|From start of study drug administration up to 30 days after the last dose of study drug|Safety population included all participants who received any treatment of study drug.|||Participants|||Number
1230833|NCT00659425|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events (5% cut off) for laboratory abnormalities were reported as clinically relevant laboratory changes.|From start of study drug administration up to 30 days after the last dose of study drug|Safety population included all participants who received any treatment of study drug.|||Participants|||Number
1230884|NCT00658788|Primary|Overall Disease Severity Success (ODS)|Success was defined as a one-grade improvement in ODS from baseline.|8 and 12 weeks|The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.|||percentage of participants||95% Confidence Interval|Number
1230834|NCT00659425|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Vital signs included parameters as heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.|From start of study drug administration until 30 days after the last dose of study drug|Safety Population included all participants who received any treatment of study drug.|||Participants|||Number
1230835|NCT00659425|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From start of study drug administration until 30 days after the last dose of study drug|Safety Population included all participants who received any treatment of study drug.|||Participants|||Number
1230836|NCT00659425|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication.|Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)|"Evaluable Population for DLT included all participants who received any treatment of moxetumomab pasudotox (CAT-8015) and completed the DLT period without a DLT, or did not complete the DLT period due to a DLT. Here, N is number of participants evaluated for this outcome measure."|||participants|||Number
1230837|NCT00659373|Primary|Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)|Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study.|1 year after patient randomization to parent IBCSG 24-02 study||||standardized units||Standard Deviation|Mean
1230838|NCT00659360|Secondary|Time to Disease Progression|"The Kaplan-Meier method will be used to estimate time to progression estimates.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 5 years||||months||95% Confidence Interval|Median
1230839|NCT00659360|Secondary|Duration of Response|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;~Objective Tumor Response of more than 4 months was counted toward the Disease Control Rate."|Up to 5 years|Patients who had partial response, complete response or stable disease|||participants|||Number
1230840|NCT00659360|Secondary|Stable Disease Rate|Achieved stable disease as their best response|Up to 5 years||||participants|||Number
1230841|NCT00659360|Secondary|Overall Survival|Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.|Up to 5 years||||months||95% Confidence Interval|Median
1230842|NCT00659360|Secondary|Objective Response Rate|Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 5 years||||participants|||Number
1230843|NCT00659360|Primary|Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.|Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|Up to 5 years||||participants|||Number
1230844|NCT00659334|Secondary|Compare Pre- and Post-op Gd Enhanced MRI Combidex Enhanced MR Imaging Done Pre-, Intra- and Post-operatively, to Assess the Degree of Resection and Residual Tumor.||2 years|||||||
1230845|NCT00659334|Secondary|Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.||2 years|||||||
1230846|NCT00659334|Secondary|Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue||2 years|||||||
1230847|NCT00659334|Primary|Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.|Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.|24 hours (some patients between 3 and 72 hours) after administration of Combidex||||Participants|||Number
1230848|NCT00659295|Primary|Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events|The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.|Months 0-12|FAS (Full Analysis Set) consists of all patients with a baseline visit who were prescribed insulin detemir at least once|||participants|||Number
1230849|NCT00659269|Primary|Change in Neurotoxicity Assessment Between Cycle 4 and Baseline|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.|4 weeks|Of the 92 & 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 & 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 & 20 patients in Group 2 (Heavy Metals) and 5 & 9 patients in Group 3 (Vinca)|||units on a scale||Standard Deviation|Mean
1230850|NCT00659269|Primary|Neurotoxicity Assessment at Cycle 4|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.|4 weeks|Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 & 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 & 21 patients in Group 2 (Heavy Metals) and 6 & 9 patients in Group 3 (Vinca)|||units on a scale||Standard Deviation|Mean
1230851|NCT00659269|Primary|Neurotoxicity Assessment at Cycle 2|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.|2 weeks|Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 & 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 & 25 patients in Group 2 (Heavy Metals) and 9 & 10 patients in Group 3 (Vinca)|||units on a scale||Standard Deviation|Mean
1230852|NCT00659269|Primary|Neurotoxicity Assessment at Baseline|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.|At study start; prior to treatment (week 0)|Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)|||units on a scale||Standard Deviation|Mean
1230853|NCT00659230|Secondary|Clinician Administered PTSD Scale Subscale C Score|The Clinician Administered PTSD Subscale C (CAPS-C) measures the Avoidance and emotional numbing cluster of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS-C is zero to 56. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2, 4, and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).|||units on a scale||Standard Deviation|Mean
1230854|NCT00659230|Secondary|Clinician Administered PTSD Scale Subscale B Score|The Clinician Administered PTSD Subscale B (CAPS-B) measures the re-experiencing cluster of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS-B is zero to 40. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78). Blake, D.D., Weathers, F.W., Nagy, L.M., Kaloupek, D.G., Gusman, F.D., Charney, D.S., Kean, T.M., 1995, The development of a clinician-administered PTSD scale. Journal of Traumatic Stress, 8:75-90.|6 weeks|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).|||units on a scale||Standard Deviation|Mean
1230855|NCT00659230|Secondary|Clinician Administered PTSD Scale Total Score|The Clinician Administered PTSD Scale (CAPS) measures the full spectrum of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS is zero to 136. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2,4, and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).|||units on a scale||Standard Deviation|Mean
1231415|NCT00653263|Secondary|Hamilton Depression Rating Scale (HAM-D) Rating Score|Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above.|4 weeks||||"Units on a scale"||Standard Deviation|Mean
1230856|NCT00659230|Primary|Clinician Administered PTSD Scale Subscore D (Hyperarousal)|The Clinician Administered PTSD Scale subscore D (CAPS-D) measures the hyperarousal cluster for PTSD symptoms (5 items). Higher scores indicate greater severity. Range for CAPS-D is zero to 40. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2, 4 and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).|||units on a scale||Standard Deviation|Mean
1230857|NCT00659165|Primary|Calories Consumed After Fast.|Total energy ingested following the 24 hour fast.|Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks||||kcal||Standard Deviation|Mean
1230858|NCT00659061|Secondary|Percentage of Participants With Wasted Growth|Wasted defined as Weight for Height Z-score < -2SD|Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment|those who had complete anthropometric measurements at endline|||percentage of participants|||Number
1230859|NCT00659061|Secondary|Percentage of Participants With Stunted Growth|Stunted defined as Height for Age Z-score < -2 standard deviation|Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment|Those who had complete anthropometric measurements at endline|||percentage of participants|||Number
1230860|NCT00659061|Secondary|Percentage of Underweight Participants|Underweight defined as Weight for Age Z score < -2 standard deviation (SD)|Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment|those who had complete baseline anthropometric measures|||percentage of participants|||Number
1230861|NCT00659061|Primary|Mean Hemoglobin of Participants Post Intervention||Endline Hb taken 4-5 months post enrollment||||g/dL||95% Confidence Interval|Mean
1230862|NCT00659061|Primary|Number of Participants With Moderate to Severe Anemia|number of participants with moderate - severe anemia defined as Hb < 10g/dL|Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment||||participants|||Number
1230863|NCT00659061|Secondary|Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention||Measurement taken 4-5 months post enrollment||||ug/dl||95% Confidence Interval|Mean
1230864|NCT00659061|Secondary|Vitamin A Status of Participants - Post Intervention|Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl|Measurement taken 4-5 months post enrollment|those who had endline assessment of serum vitamin A|||participants|||Number
1230865|NCT00659061|Primary|Number of Participants With Anemia|number with mild to severe anemia (hemoglobin(Hb)<11g/dL)|Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment||||participants|||Number
1230866|NCT00658996|Primary|Contact Lens High Contrast Visual Acuity|VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test – Control) in overall logMAR VA.|Over-all follow-up visits, 2 weeks|All eligible, dispensed eyes|||LogMAR|Participants|Standard Deviation|Mean
1230867|NCT00658996|Secondary|Slit Lamp Findings|Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates|Over-all follow-up visits, 2 weeks|All dispensed eyes, over all follow-up visits|||Eyes|Participants||Number
1230868|NCT00658996|Primary|Symptoms and Complaints|1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.|Over-all follow-up visits for 2 week period|All eligible, dispensed eyes, Overall follow-up visits.|||Scores on a Scale|Participants|Standard Deviation|Mean
1230869|NCT00658814|Secondary|Relapse-free Survival|Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.|Up to 5 years||||months||95% Confidence Interval|Median
1230870|NCT00658814|Primary|30-Day Survival|Patients surviving more than 30 days after study registration|30 days||||percentage of participants||95% Confidence Interval|Number
1230871|NCT00658814|Primary|Complete Response|Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL.|Up to 60 days||||percentage of participants||95% Confidence Interval|Number
1230872|NCT00658814|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1230873|NCT00658788|Secondary|Tolerability Assessment - Folliculitis||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
1230874|NCT00658788|Secondary|Tolerability Assessment - Skin Atrophy||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
1230875|NCT00658788|Secondary|Tolerability Assessment - Stinging/ Burning||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
1230876|NCT00658788|Secondary|Tolerability Assessment - Telangiectasias||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
1230877|NCT00658788|Secondary|Tolerability Assessment - Pruritus||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
1230878|NCT00658788|Secondary|Overall Disease Severity||2, 4, 8 and 12 weeks||||participants|||Number
1230879|NCT00658788|Secondary|Percent Change From Baseline in Body Surface Area (% BSA) Affected||2, 4, 8 and 12 weeks||||Percent Change from Baseline||Standard Deviation|Mean
1230880|NCT00658788|Secondary|Signs of Psoriasis - Plaque Elevation||2, 4, 8 and 12 weeks||||participants|||Number
1230881|NCT00658788|Secondary|Signs of Psoriasis - Scaling||2, 4, 8 and 12 weeks||||participants|||Number
1230885|NCT00658775|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present) Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|ITT Population|||Percentage of Participants|||Number
1230886|NCT00658775|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present) Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|ITT Population - all randomized subjects who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1230887|NCT00658775|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|ITT Population|||Percentage of Participants|||Number
1230888|NCT00658736|Secondary|Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component|The SF12 survey measures patients' impressions of their level of health and well-being. The results are reported as two scores: A physical component and a mental component, each of which is reported on a scale of 0 (lowest level of health) to 100 (excellent health). Scores that increase from baseline indicate an improvement in patients' feelings of well-being.|1 month||||units on a scale||Standard Deviation|Mean
1230889|NCT00658736|Primary|Change in Pain Disability Index|The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.|1 month after block||||Participants|||Count of Participants
1230890|NCT00658723|Secondary|Incidence of Adverse Events||30 days (+14 days)||||% if participants with atleast one AE|||Number
1230891|NCT00658723|Secondary|Incidence of Re-treatment|"The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.~In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment."|Intra-operative||||participants|||Number
1230892|NCT00658723|Secondary|Incidence of Adverse Events Potentially Related to Transfusion Exposure|The types of events that were potentially related to transfusion exposure could have include hypocalcemia.|Intra-operative up to 1 month (+14 days)||||percentage of particpants|||Number
1230893|NCT00658723|Secondary|Incidence of Adverse Events That Are Potentially Related to Thrombotic Events|The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism|Intra-operative up to 1 month (+14 days)||||percentage of participants|||Number
1230894|NCT00658723|Secondary|Incidence of Adverse Events That Are Potentially Related to Bleeding|The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).|Intra-operative up to 1 month (+14 days)||||percentage of particpants|||Number
1230895|NCT00658723|Secondary|Incidence of Treatment Failures|If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.|Intra-operative||||percentage of treatment failure|||Number
1230896|NCT00658723|Secondary|Proportion of Subjects Achieving Hemostatic Success|The proportion of subjects achieving hemostatic success at 10 minutes following randomization|10 minutes||||percentage of success|||Number
1230897|NCT00658723|Primary|Proportion of Subjects Achieving Hemostatic Success|Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.|Intra-operative||||percentage of success|||Number
1230898|NCT00658697|Secondary|Toxicity|Treatment related adverse events were graded based on CTCAE v. 3.0.|Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years|All patients received at least one study therapies|||participants|||Number
1230899|NCT00658697|Primary|Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)|"For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL.~For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA >2.0 ng/mL.~Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression."|participants were followed for the duration of the study, an average of 2 years||||percentage of participants with data||95% Confidence Interval|Number
1230900|NCT00658697|Secondary|Testosterone Recovery|Testosterone recovery was defined as >100 or within DFCI institute normal range (240-950) at one year after the completion of ADT|2 years|All treated patients with assessable testosterone level data|||percentage of participants with data||95% Confidence Interval|Number
1230901|NCT00658697|Secondary|Time to PSA Progression (TTP)|For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA > 2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value|participants were followed for the duration of the study, an average of 2 years|the analysis dataset is comprised of all treated patients|||months||95% Confidence Interval|Median
1230902|NCT00658697|Secondary|Proportion of Patients With PSA Responses at One Year After the Completion of ADT|The PSA response was defined using two cut-offs: PSA <0.2 ng/mL or PSA <0.01 ng/mL at the one year after completion of ADT.|1 year + 3 month off last ADT injection|"The analysis comprised of all patients received at least one treatment and had PSA data available* for the assessment of PSA responses at one year after completing ADT~*Note excluded 5 patients started treatments but had no PSA information at one year."|||percentage of participants with data||95% Confidence Interval|Number
1230903|NCT00658684|Primary|Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume|The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.|52 Weeks|The safety analysis set (all subjects who took at least one dose of study drug) was analyzed.|||Number of subjects|||Number
1230904|NCT00658684|Secondary|Change From Baseline in Grade of PPBC at Week 28 and 52|"The PPBC assessment was rated on a 6-point scale as follows:~no problems at all~some very minor problems~some minor problems~some moderate problems~severe problems~many severe problems~Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement."|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)|||Scores on a scale||Standard Deviation|Mean
1230905|NCT00658684|Secondary|The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage|"The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:~no problems at all~some very minor problems~some minor problems~some moderate problems~severe problems~many severe problems"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)|||Number of subjects|||Number
1230906|NCT00658684|Secondary|Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52|"OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).~Change: mean at Week 28 and 52 minus mean at baseline"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)|||Scores on a scale||Standard Deviation|Mean
1230907|NCT00658684|Secondary|Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52|"KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.~KHQ consists of the following domains:~General health perceptions (GHP)~Impact on life~Role limitations~Physical limitations~Social limitations~Personal relationships (PR)~Emotions~Sleep/energy~Incontinence severity measures (ISM)~Change: mean at Week 28 and 52 minus mean at Baseline"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)|||Scores on a ascle||Standard Deviation|Mean
1230908|NCT00658684|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were analyzed. (n=number of analyzable subjects)|||mL||Standard Deviation|Mean
1230909|NCT00658684|Secondary|Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52|"The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of nighttime micturitions per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)|||Number of micturitions||Standard Deviation|Mean
1230918|NCT00658658|Primary|Area Under the Concentration-time Curve During the Dosing Interval (AUC0-tau) for Panitumumab|The area under the serum concentration-time curve from time zero to the end of the dosing interval (AUCtau), estimated using the linear trapezoidal method.|First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."|||day*μg/mL||Standard Deviation|Mean
1230910|NCT00658684|Secondary|Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of incontinence episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n= number of analyzable subjects)|||Number of episodes||Standard Deviation|Mean
1230911|NCT00658684|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)|||Number of episodes||Standard Deviation|Mean
1230912|NCT00658684|Secondary|Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52|"The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of anlyzable subjects)|||Number of micturitions||Standard Deviation|Mean
1230913|NCT00658684|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of UUI episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using last observation carried forward (LOCF) were analyzed. (n=number of analyzable subjects)|||Number of episodes||Standard Deviation|Mean
1230914|NCT00658658|Secondary|Percentage of Participants With Disease Control|"Disease assessments were based on investigator review of scans using modified RECIST version 1.0 criteria. A participant was considered to have disease control if their best response is either a complete or partial response, or stable disease. Participants without a post-baseline assessment were considered to not have disease control. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. A best overall response of SD requires a visit response of SD or better, no earlier than 49 days after the date of enrollment.~Stable disease (SD): Neither sufficient shrinkage of target lesions to qualify for a PR nor sufficient increase to qualify for PD and no progression of existing non-target lesions and no new lesions."|Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.|Safety Analysis Set participants with presence of baseline measurable disease|||percentage of participants||95% Confidence Interval|Number
1230915|NCT00658658|Secondary|Percentage of Participants With an Objective Response|Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria. A participant was considered a responder if their best response was either a complete or partial response. Participants without a post-baseline assessment were considered non-responders. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response (CR): Disappearance of all target and non-target lesions, normalization of tumor markers and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions, no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) or/and maintenance of tumor marker level above normal limits, and no new lesions.|Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.|Safety Analysis Set participants with presence of baseline measurable disease|||percentage of participants||95% Confidence Interval|Number
1230916|NCT00658658|Primary|Serum Clearance (CL) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."|||mL/day/kg||Standard Deviation|Mean
1230917|NCT00658658|Primary|Half-life (t1/2) for the Terminal Phase (First Dose) or Dosing Interval (Third Dose) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."|||days||Standard Deviation|Mean
1230919|NCT00658658|Primary|Minimum Observed Concentration (Cmin) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."|||μg/mL||Standard Deviation|Mean
1230920|NCT00658658|Primary|Maximum Observed Concentration (Cmax) of Panitumumab|Panitumumab serum concentration was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 400 pg/mL. Concentrations below the LLOQ were set to zero.|First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"Pharmacokinetic (PK) Analysis Set (all participants who received the correct dose of panitumumab and from whom the PK parameters could be assessed); n indicates the number of participants with available data for each time point."|||μg/mL||Standard Deviation|Mean
1230921|NCT00658658|Primary|Number of Participants With Adverse Events (AEs)|A serious adverse event is defined as an AE that: • is fatal; • is life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • is a congenital anomaly/birth defect; • other significant medical hazard. The investigator assessed whether adverse events were related to panitumumab. The severity of adverse events was based on CTCAE version 3 (with the exception of skin- or nail-related toxicities which were graded using the CTCAE version 3.0 with modifications), according to the following: Grade 1 = Mild (aware of sign or symptom, but easily tolerated); Grade 2 = Moderate (discomfort enough to cause interference with usual activity); Grade 3 = Severe (incapacitating with inability to work or do usual activity); Grade 4 = Life-threatening or disabling; Grade 5 = Fatal.|From first dose date to end of study date. The median duration of study was 47 days.|Safety Analysis Set (all participants who received at least 1 dose of panitumumab)|||participants|||Number
1230922|NCT00658658|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|Three validated assays were used to detect the presence of anti-panitumumab antibodies. Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. All samples confirmed to be positive by drug specificity in either screening immunoassay were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay. The number of participants who developed antibodies to panitumumab is the number of participants with a non-positive (including missing) antibody result at baseline and a positive antibody result at any post-baseline time point.|Before panitumumab administration on Day 1, Day 43, Day 169 and 30 days after last dose for all cohorts.|Safety Analysis Set participants with at least one post-baseline immunoassay result|||participants|||Number
1230923|NCT00658658|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Any panitumumab related grade 3 or 4 hematologic or non-hematologic toxicity (graded according to the modified Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria) was considered a DLT with the exception of alopecia and fatigue. Hypomagnesemia, nausea, diarrhea, vomiting, and skin or nail toxicities constituted a DLT only of the following occured: • Grade 3 or 4 hypomagnesemia that persisted for at least 5 days despite maximal magnesium replacement; • Grade 3 or 4 diarrhea, nausea, or vomiting that persisted for at least 5 days despite maximum supportive therapy; • Grade 4 skin or nail toxicity.|28 days from initial administration of panitumumab for the 2.5 and 6 mg/kg cohorts and 21 days from first administration for the 9 mg/kg cohort.|DLT Analysis Set (all participants who received at least 1 dose of panitumumab and were evaluated for DLTs and completed at least 28 days (for the 2.5 and 6 mg/kg cohorts) or 21 days (for 9 mg/kg cohort) of therapy unless due to a DLT)|||participants|||Number
1230924|NCT00658632|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.|||Percentage of Participants|||Number
1230925|NCT00658632|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.|||Percentage of Participants|||Number
1230926|NCT00658632|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.|||Percentage of Participants|||Number
1231318|NCT00654745|Secondary|Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks|change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.|week 0 - weeks 3, 6, 9, 12, 15, 18|Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.|||mm Hg||Standard Error|Mean
1230927|NCT00658619|Secondary|Change From Baseline in Reading Speed in the Study Eye|Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2|||Words per Minute (wpm)||Standard Deviation|Mean
1230928|NCT00658619|Secondary|Change From Baseline in Contrast Sensitivity in the Study Eye|Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2|||Number of Letters Read Correctly||Standard Deviation|Mean
1230929|NCT00658619|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2|||Number of Letters Read Correctly||Standard Deviation|Mean
1230930|NCT00658619|Secondary|Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye|Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).|Baseline, Month 3, Month 6, Month 9, Month 18, Month 24|Intent-to-Treat: All randomized patients who participated in Stage 2|||Disc Area||Standard Deviation|Mean
1230931|NCT00658619|Primary|Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye|Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).|Baseline, Month 12|Intent-to-Treat: All randomized patients who participated in Stage 2|||Disc Area||Standard Deviation|Mean
1230932|NCT00658606|Secondary|Change in Dermatology Life Quality Index (DLQI)|"The DLQI questionnaire is intended to measure how much a subject’s skin problem affects the subject’s life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst).~A negative change from Baseline represents improvement.~Change is calculated as Week 36- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."|||DLQI Score||Standard Deviation|Mean
1230933|NCT00658606|Secondary|Time for a 75% Decrease in PASI|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~Only subjects who experienced 75% decrease in PASI were included in the analysis."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who experienced a 75% decrease in PASI were included in the analysis."|||Days||Inter-Quartile Range|Mean
1230934|NCT00658606|Secondary|Time for 50% Decrease in PASI|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~Only subjects who experienced 50% decrease in PASI were included in the analysis."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who experienced a 50% decrease in PASI were included in the analysis."|||Days||Inter-Quartile Range|Median
1230935|NCT00658606|Secondary|Time to Relapse|"The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed.~Relapse is defined by a loss of 50% of improvement in PASI."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who achieved a 75% improvement in PASI and then relapsed were included in the analysis."|||Days||Standard Deviation|Mean
1230936|NCT00658606|Secondary|Percentage of Subjects Who Achieve PASI 90 at Week 16|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 90 was defined as an improvement of at least 90% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).|||Percentage of Subjects|||Number
1230964|NCT00658359|Secondary|Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Months 24, 36, 48, 60, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Percentage||Standard Deviation|Mean
1230937|NCT00658606|Secondary|Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study|"The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.~Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 36|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).|||Percentage of Subjects|||Number
1230938|NCT00658606|Secondary|Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16|"The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.~Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).|||Percentage of Subjects|||Number
1230939|NCT00658606|Secondary|Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study|"A negative change from Baseline represents improvement.~Change is calculated as Week 36- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."|||Percentage of BSA||Standard Deviation|Mean
1230940|NCT00658606|Secondary|Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16|"A negative change from Baseline represents improvement.~Change is calculated as Week 16- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 16|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."|||Percentage of BSA||Standard Deviation|Mean
1230941|NCT00658606|Secondary|Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who completed follow-up were included in this analysis."|||Percentage of Subjects|||Number
1230942|NCT00658606|Primary|Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).|||Percentage of Subjects|||Number
1230943|NCT00658567|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The total possible score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: ANCOVA, and missing data was imputed using LOCF method. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.|||Score on UPDRS-II+III scale.||95% Confidence Interval|Least Squares Mean
1230944|NCT00658567|Primary|Antipsychotic Efficacy|"Antipsychotic efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 1 to 100 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.|||Scores on the SAPS H+D scale||95% Confidence Interval|Least Squares Mean
1230945|NCT00658541|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate|The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.|||ng-hr/mL||Standard Deviation|Mean
1231319|NCT00654745|Secondary|Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment|Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP|week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)||||mm Hg||Standard Error|Mean
1230946|NCT00658541|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.|||ng-hr/mL||Standard Deviation|Mean
1230947|NCT00658541|Primary|Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate|The maximum or peak concentration that zolpidem tartrate reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.|||ng/mL||Standard Deviation|Mean
1230948|NCT00658528|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|ITT Population|||Percentage of Participants|||Number
1230949|NCT00658528|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1230950|NCT00658528|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of hearburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|ITT Population|||Percentage of Participants|||Number
1230951|NCT00658411|Secondary|1-year Post-Transplant Survival|Survival information for the 5 patients who were treated with deferoxamine was collected. This information was used to determine transplant-related mortality, relapse, disease-free and overall survival.|1 year|Stopped early for poor accrual|||participants|||Number
1230952|NCT00658411|Primary|Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.|"All patients meeting the criteria for Severe iron overload as defined by BOTH:~ferritin ≥ 1000 ng/ml and liver iron content(LIC) ≥ 5 mg/gdw were enrolled and received chelation therapy with Deferoxamine. All patients who received chelation therapy were monitored for grade 3 or above toxicity Attributable to Deferoxamine(grades defined by the CTCAE Version 3). The number of participants with grade 3 or higher toxicities were measured and used to determine the safety of chelation therapy."|Baseline , 6 month, 1 year|Patients who met criteria for iron overload pre-transplant, as defined by the protocol, were enrolled on study for chelation therapy. Those patients who received therapy were monitored for toxicities using the CTCAE version 3.0.|||Participants|||Number
1230953|NCT00658385|Primary|Number of Participants With no Serious Adverse Events|The entered value represents the number of participants with the absence of serious adverse events. G-CSF mobilization will be considered safe if there are no more than 1 of 5 patients with SAEs|Up to 14 Days||||participants|||Number
1230954|NCT00658359|Secondary|Mean Trough Levels of Cyclosporine by Visit|All CsA samples were taken predose (collected 0 to 10 minutes prior to the morning dose).|Predose: Months 18, 24, 36, 48, 60, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||ng/mL||Standard Deviation|Mean
1230955|NCT00658359|Secondary|Mean Trough Levels of Tofacitinib by Visit|The dates and times were recorded for the 6 doses of tofacitinib administered before each scheduled pharmacokinetic (PK) sampling. The participant was instructed to follow a 12 hourly schedule for these 6 doses of tofacitinib, with each dose administered within 1 hour of the scheduled time. Trough samples were collected 0 to 10 minutes prior to the morning dose. 1 hour postdose samples were required within 10 minutes of the nominal time point. Samples taken at -2 hours predose and at time points >1 hour post dose were required within 30 minutes of the nominal time point.|Months 18 and 24 (-2 hours, predose, 1 hour, 2 hours), Month 30 (predose, 1 hour and 2 hours), Month 36 (predose, 1, 2, and 4 hours), Months 42, 48, 54, 60, 66, 72 (predose and 2 hours)|Safety Analysis Set. n is the number of participants with the assessment at each time point.|||ng/mL||Standard Deviation|Mean
1230965|NCT00658359|Secondary|Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit|Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||g/dL||Standard Deviation|Mean
1230966|NCT00658359|Secondary|Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit|Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||k/mm^3||Standard Deviation|Mean
1230956|NCT00658359|Secondary|Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36|"SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia; consists of 3 subscales: Pain Intensity (PI, 6-items to assess pain and intensity of abdominal discomfort; Range: 2 to 47, higher score indicates greater pain and abdominal discomfort), Non-Pain Symptoms (NPS, 7-items to assess severity and impact of non-pain symptoms: burping/belching, heartburn, bloating, flatulence, sour taste, nausea, and bad breath; Range: 7 to 35, higher scores indicate increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with abdominal discomfort; Range: 2 to 23, higher scores indicate more satisfaction).~Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used."|Months 24, 36|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Score||Standard Error|Least Squares Mean
1230957|NCT00658359|Secondary|Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36|"ESRD-SCL: a 43-item disease specific self-administered questionnaire. Participants’ rated the question “At the moment,how much do you suffer?” for each item on a 5 point scale, range (Ra) from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: Cardiac and Renal (CR) dysfunction; Ra 0 to 28, Increased(In) Growth of Gum and Hair (IGGH); Ra 0 to 20, Limited Cognitive Capacity (LCC); Ra 0 to 32, Limited Physical Capacity (LPC); Ra 0 to 40, Side Effects (SEs) of Corticosteroids; Ra 0 to 20, Transplantation Associated Psychological Distress (TAPD); Ra 0 to 32. Total Score: 0 to 172, higher scores indicate greater dysfunction.~Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used."|Months 24, 36|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Score on a scale||Standard Error|Least Squares Mean
1230958|NCT00658359|Secondary|Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36|SF-36 v2 is a self-administered 36-item generic health status measure with 8 general health concepts which are the weighted sums of the questions in their section: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each scale is transformed into a 0 (minimum) to 100 (maximum) scale on the assumption each question carries equal weight. These concepts were also summarized into 2 summary scores; Physical Component Summary and Mental Component Summary (both a 0-100 scale). The 8 subscales, 2 summary scores and transition Question 2 (TR Scale, measured on a scale of 1 [minimum] to 5 [maximum]) were subjected to analysis. Higher domain, summary scores, and TR scale scores indicate better health status. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. First-order autoregressive variance-covariance structure was used.|Months 24, 36|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Score on a scale||Standard Error|Least Squares Mean
1230959|NCT00658359|Secondary|Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit|"GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR (mL/min/1.73 m^2) by MDRD equation = 170 * (serum creatinine [mg/dL])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration [mg/dL])^(-0.170) * (serum albumin concentration [g/dL])^(0.318). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.~Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used."|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
1230960|NCT00658359|Secondary|Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit|"GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR (mL/min) was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.~Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used."|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||min/mL||Standard Error|Least Squares Mean
1230961|NCT00658359|Secondary|Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit|"GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Nankivell formula, where:~Creatinine clearance (mL/min) = 6.7/serum creatinine (millimols per litre [mmol/L]) - serum urea (mmol/dL)/2 + actual body weight (kilograms [kg])/4 - 100/Height (metres [m])^2 + (35 for male or 25 for female).~A normal GFR for adults is > 90 mL/min. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.~Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used."|Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||minutes per milliliter (min/mL)||Standard Error|Least Squares Mean
1230962|NCT00658359|Secondary|Percentage of Participants by Proteinuria Category by Visit|Proteinuria was defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.|Months 24, 36, 48, 60, 72 and Follow-up|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Percentage of Participants|||Number
1230963|NCT00658359|Secondary|Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A compund symmetry variance-covariance structure was used.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Population. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
1230967|NCT00658359|Secondary|Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.|Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Population. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
1230968|NCT00658359|Secondary|Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
1230969|NCT00658359|Secondary|Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
1230970|NCT00658359|Secondary|Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
1230971|NCT00658359|Secondary|Percentage of Participants Discontinuing From the Study|Discontinuations were due to any reason including those occurring as a result of protocol Amendments 3 and 4.|Months 12 through 72.|Safety Analysis Set|||Percentage of Participants|||Number
1230972|NCT00658359|Secondary|Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit|The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
1230973|NCT00658359|Secondary|Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit|Graft loss was defined as graft nephrectomy, subject death, retransplantation, or return to dialysis for at least 6 consecutive weeks. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of participants||60% Confidence Interval|Number
1230974|NCT00658359|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit|Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: ‘suspicious’ for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection was calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
1230975|NCT00658359|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit|Efficacy failure was the first occurrence of BPAR diagnosed by the central pathologist or graft loss including participant death. BPAR (category acute rejection) was interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
1230976|NCT00658359|Primary|Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit|Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
1230977|NCT00658359|Primary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit|BPAR was category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
1230978|NCT00658359|Primary|Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36|Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]). The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 36 Banff-CS greater than the implantation biopsy score indicated progression of lesions.|Month 36|FAS. Only participants with Banff CS values at both Day 0 and Month 36 visits were included.|||Percentage of Participants|||Number
1230979|NCT00658359|Primary|Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min])|Glomerular filtration rate (GFR): an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous (IV) bolus over 5 minutes immediately after morning dosing of Tofacitinib or CsA on day of GFR evaluation. Blood samples for iohexol (3 millilitres [mL] each to provide a minimum of 1 mL serum) were collected into appropriately labeled tubes containing no additives at 120, 180, 240, and 300 minutes after the end of the iohexol IV bolus. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure.|Month 36|Full analysis set (FAS, which was defined the same as the Safety Analysis Set). The analysis included 1 participant in CsA and 2 in Tofacitinib LI from before protocol Amendment 1. Only subjects at Month 36 with GFR calculations were included.|||mL/min||Standard Error|Least Squares Mean
1230980|NCT00658359|Primary|Percentage of Participants With Malignancies|All treatment-emergent malignancies in Study A3921050 were included as collected on the Malignancy Case Report Form page.|Months 12 through 72.|Safety Analysis Set. Percentages use n (the number of participants with malignancies: 7,8,8 respectively) and include 1 participant in CsA and 2 in Tofacitinib LI from before dose reduction to 5 mg by Month 18 was implemented (protocol Amendment 1)|||Percentage of Participants|||Number
1230981|NCT00658359|Primary|Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit|Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
1230982|NCT00658333|Secondary|Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals|The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).|Baseline and week 4 to week 6|Safety Population|||mg||Standard Deviation|Mean
1230983|NCT00658333|Primary|Number of Participants With Response (Yes/no)|The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.|6 weeks|Intent to Treat Population|||Participants|||Number
1230984|NCT00658320|Primary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula|"Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula:~GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R C is the serum concentration of creatinine [mg/dL] A is age [years] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1"|Month 48|Participants from the Extension Intent-to-treat population with data available for analyses.|||mL/min/1.73m^2||Full Range|Median
1230985|NCT00658320|Secondary|Extension Study: Cyclosporine Trough Levels|Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) cyclosporine levels and was analyzed at a central laboratory using immunoassay.|Month 24, Month 48|Participants from the Extension safety population with data available for analyses.|||ng/mL||Standard Deviation|Mean
1230986|NCT00658320|Secondary|Extension Study: Everolimus Trough Levels|Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) everolimus levels and was analyzed at a central laboratory using liquid chromatography mass spectrometry.|Month 24, Month 48|Participants from the Extension safety population with data available for analyses.|||ng/mL||Standard Deviation|Mean
1230987|NCT00658320|Secondary|Extension Study: Number of Participants With Adverse Events and Serious Adverse Events|Additional information about Adverse Events can be found in the Adverse Event Section.|24 Months|Participants from the Extension Safety Population.|||Participants|||Number
1230988|NCT00658320|Secondary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR) Using the Nankivell Formula|"The Nankivell formula was used to calculate GFR at Month 24:~GFR[mL/min]=6.7/C + W/4 - UREA/2 - 100/H^2 + 35 (25 for females) W= body weight [kg] H= height [m] C= serum creatinine [mmol/L] UREA= serum urea [mmol\L]"|Month 24, Month 48|Participants from the Extension Intent-to-treat population with data available for analyses.|||mL/min||Standard Deviation|Mean
1230989|NCT00658320|Secondary|Extension Study: Number of Participants With Combined Efficacy Endpoint: Graft Loss, Death, Loss to Follow-up and/or Treated Biopsy Proven Acute Rejection (BPAR)|"Graft loss was defined as the day the patient started dialysis and was not able to subsequently be removed from dialysis or re-transplant.~Loss-to-follow was a patient who did not experience a treated BPAR, graft loss or death and whose last day of contact was prior to Month 24.~A Graft Biopsy was done within 48 hours of suspect rejection. Biopsies were read by the local pathologist according to the updated Banff ’97 criteria.~Treated BPAR was based on local laboratory biopsy results and was defined as a biopsy Banff criteria graded IA to III that was treated with anti-rejection therapy."|24 Months|Extension Intent-to-treat population.|||Participants|||Number
1230990|NCT00658320|Primary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula|"Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula:~GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R C is the serum concentration of creatinine [mg/dL] A is age [years] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1~Loss to follow up (in In Primary Core Outcome Measure) is composite efficacy failure and contains incidence of treated BPAR, graft loss, death or loss to follow-up"|Month 24|Participants from the Extension Intent-to-treat population with data available for analyses.|||mL/min/1.73m^2||Full Range|Median
1230991|NCT00658320|Secondary|Core Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula|"Modification of Diet in Renal Disease (MDRD) formula is:~Calculated GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|Month 12||||mL/min/1.73m^2||Full Range|Median
1230992|NCT00658320|Secondary|Core Study: Number Participants With Combined Graft Loss, Death or Loss to Follow-up|"The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.~A loss to follow-up in graft loss, death or loss to follow-up is a patient who did not experience graft loss or death and whose last day of contact was prior to Day 316, i.e. prior to the Month 12 visit window."|12 months|The Intent-To-Treat (ITT) population consisted of all patients randomized after transplantation.|||Participants|||Number
1230993|NCT00658320|Primary|Core Study: Number of Patients With Composite Efficacy Endpoint|"The composite efficacy endpoint consisted of treated biopsy proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up. A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.~For the individual components (including loss of follow-up)of the composite endpoint, patients are counted for the first event to occur."|12 months|The Intent-To-Treat (ITT) population consisted of all patients randomized after transplantation.|||Participants|||Number
1230994|NCT00658138|Primary|Percentage of Restorations Scoring Alpha|Restorations were scored Alpha, Bravo or Charlie for retention, post-operative sensitivity, anatomic form, margin integrity, color match, stain resistance, and secondary caries. Alpha score = 'excellent' Bravo = 'acceptable' Charlie = 'unsatisfactory'. Total Alpha scores were evaluated for the primary outcome.|12 months|Analysis was based on the number of study teeth available for review at 12 months|||percentage of Alpha scores|Participants||Number
1230995|NCT00658112|Primary|Adherence|Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied|6 weeks||||percentage of doses actually applied||Full Range|Mean
1230996|NCT00657709|Secondary|Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine|The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.|upto 7 days after any vaccination|The analysis was done on safety subset population - all subjects enrolled who received study vaccination and provided post-baseline safety data.|||Participants|||Number
1230997|NCT00657709|Secondary|Percentage of Subjects With hSBA Titers ≥1:8|Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.|1 month after third vaccination|Analysis was done on PP population|||Percentages of subjects||95% Confidence Interval|Number
1230998|NCT00657709|Secondary|Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination|Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.|1 Month after third vaccination|Analysis was done on PP dataset.|||Percentages of Subjects||95% Confidence Interval|Number
1230999|NCT00657709|Secondary|Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens|Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).|5 months|Analysis was done on PP dataset.|||Percentages of Subjects||95% Confidence Interval|Number
1231000|NCT00657709|Secondary|Percentages of Subjects With Antibody Response Against the Routine Antigens|"The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.~HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml"|1 Month after third vaccination|Analysis was done on PP population.|||Percentages Of Subjects||95% Confidence Interval|Number
1231001|NCT00657709|Secondary|Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations|Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.|1 month after third vaccination|Analysis was done on Immunogenicity Routine PP (Pertussis Antigens)|||IU/mL||95% Confidence Interval|Geometric Mean
1231002|NCT00657709|Secondary|Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)|The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.|1 month after third vaccination|Analysis was done on PP dataset.|||IU/mL||95% Confidence Interval|Geometric Mean
1231003|NCT00657709|Secondary|Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ|The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.|1 Month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
1234097|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||unit per liter [U/L]||Full Range|Median
1231004|NCT00657709|Secondary|The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)|The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.|1 month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
1231005|NCT00657709|Primary|The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)|The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.|one month after the third vaccination|Analysis was done on PP population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
1231006|NCT00657709|Primary|The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination|The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).|one month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
1231007|NCT00657657|Secondary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine||||subjects|||Number
1231008|NCT00657657|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine||||subjects|||Number
1231009|NCT00657657|Secondary|Concentration of Anti-HBs Antibodies|Concentrations are given as Geometric Mean Concentrations (GMCs), calculated on subjects seropositive (subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL) post-challenge dose.|One month after the hepatitis B vaccine challenge dose||||mIU/mL||95% Confidence Interval|Geometric Mean
1231010|NCT00657657|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values|Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.|One month after the hepatitis B vaccine challenge dose||||subjects|||Number
1231011|NCT00657657|Primary|Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine|"Immune response to a challenge dose of hepatitis B vaccine is defined as~at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or~a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (<3.3 mIU/mL) at the previous available long-term time point."|One month after the hepatitis B vaccine challenge dose||||subjects|||Number
1231012|NCT00657618|Primary|Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events|The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required.|prior to infusion on days 2) 5, 10, 15, 20, 25, and 28|74 patients received at least one dose of IV pentostam|||Participants|||Count of Participants
1231013|NCT00657618|Primary|Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience|The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required.|prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28|74 patients received at least one dose of IV pentostam|||Participants|||Count of Participants
1231014|NCT00657553|Primary|Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2|"The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates.~Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication."|three years|||||||
1231015|NCT00657540|Secondary|Drug-related Serious Adverse Events|The number of subjects with drug-related serious adverse events.|Start of Dose 1 through 17 days post treatment||||Participants|||Count of Participants
1231016|NCT00657540|Secondary|Number of Participants With at Least 13 mm Reduction in Pain Score at Any Time Point|The number of patients with a clinically significant decrease in pain intensity relative to baseline at any time point during the treatment phase was measured by the patient's self-assessment of pain intensity using the visual analog scale (VAS). A clinically significant reduction in pain was defined as a decrease in VAS scores of greater than or equal to 13 mm. The VAS ranged from 0 (no pain) to 100 mm (worst possible pain).|Start of Dose 1 to any post-infusion time point||||Participants|||Count of Participants
1231017|NCT00657540|Secondary|Drug-related Adverse Events|To evaluate safety of Analatro, the number of subjects experiencing at least one adverse event (AE) that was determined to be related to study drug was computed for each treatment group. All AEs classified as definitely or possibly related to study drug were considered drug-related.|Start of Dose 1 through 17 days post treatment||||Participants|||Count of Participants
1231018|NCT00657540|Secondary|Number of Participants With at Least 13 mm Reduction in Pain Score at 30 Minutes Post-Treatment|The number of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment (after Dose 1 and Dose 2, as applicable) will be measured by the patient's self-assessment of pain intensity using the visual analog scale (VAS). A clinically significant reduction in pain is defined as a decrease in VAS scores of greater than or equal to 13 mm. The VAS ranged from 0 (no pain) to 100 mm (worst possible pain).|30 minutes post treatment||||Participants|||Count of Participants
1231019|NCT00657540|Primary|Number of Participants With Treatment Failure|"The primary efficacy endpoint for this study was the number of subjects in which pain control was not achieved 48 hours post-study drug infusion as identified by treatment failure. A treatment failure was defined as a subject who did not achieve pain control during the treatment phase, up to 48 hours after Dose 1 infusion start time. Subjects were deemed treatment failures if they met one or more of the following criteria:~Subject did not complete the treatment phase due to absence of clinically significant improvement in pain intensity relative to baseline at 60, 90, 120, or 150 minutes post start of Dose 1.~Subject required treatment with commercially available antivenin or prescription pain medication for signs and symptoms associated with latrodectism at any time during the treatment phase up to 48 hours after Dose 1 infusion start time."|From start of Dose 1 infusion to 48 hours post treatment|The analysis population consists of all subjects that were randomized and received any study drug (modified intent to treat population).|||Participants|||Count of Participants
1231020|NCT00657371|Primary|Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)|After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.|Total 30 minutes procedure time with TER use.|Those polyps reported for Third Eye Retroscope were additional, located behind folds and then found with the colonscope only because they were first detected with the Third Eye Retroscope.|||polyps|Participants||Number
1231021|NCT00657371|Secondary|Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.|Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total.|2 year study period to collect colonoscopy exam results|||||||
1231022|NCT00657371|Primary|Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)|After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.|Total 30 minutes procedure time with TER use.||||percent of polyps|Participants||Number
1231023|NCT00657358|Primary|Tactile Sensation|Pin prick sensory thresholds (PPT) were obtained by touching the skin in-between the first and second metacarpal bone with a 23-gauge needles which moved freely out of a 10 mL plastic syringe barrel. The pin prick sensation was modified by adding small weights to the 23-gauge needles (from 0.2 to 5.2 mg). A syringe barrel of tuberculin (TB) needles that were cut to different lengths to add the desired weight to the 23-gauge needle. The PPT was determined using the weighted 23-gauge needle in ascending order, according to the method of limits. This assessment was to evaluate whether participants were able to feel the touch of the needle. The participant’s arm was placed on a tray table. A linen sheet was suspended in-between two IV poles in such a fashion that the subject’s view of his/her hand was blocked. Normal values are between 0.21mg and 5mg.|baseline, during 20 minute infusion, and 30 minutes after completion of infusion||||weight in mg||Standard Error|Mean
1231024|NCT00657358|Primary|Cold Pain|The participant’s foot was immersed up to the ankle into a container filled with ice water of 3°C. Participants were instructed to maintain their foot in the container until the cold pain became intolerable (cold pain tolerance). The length of time was recorded in seconds. This procedure was repeated once with a gap of at least fifteen minutes in-between repeated tests. The range was 0 seconds to 120 seconds|baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion||||time in seconds to withdrawal||Standard Error|Mean
1231025|NCT00657358|Primary|Heat Pain|The thermal procedure involved a baseline assessment of heat pain threshold and tolerance. Contact heat stimuli were delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-II; Ramat Yishai, Israel), which is a peltier elementbased stimulator. Temperature levels were monitored by a thermistor and returned to a preset baseline of 32°C by active cooling at a rate of 10°C/s. The 3 × 3 cm contact probe was applied to the right forearm. The pain scale is between 0 and 10 with 1 being no pain and 10 being the worst pain imaginable|baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion||||units on a scale||Standard Error|Mean
1231061|NCT00657020|Secondary|Mean Response Time for Correct Responses During RVIP Task|"During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participants responded to single occurrences of the number 0. Mean response time for correct responses was determined."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||milliseconds (msec)||Standard Deviation|Mean
1235164|NCT00619957|Secondary|Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
1231026|NCT00657358|Primary|Electrical Pain|Peripheral nerve stimulation electrodes were attached to the base and the tip of the third digit and connected to a constant current stimulator (DS7A, Digitimer Ltd, Hertfordshire, England). Ascending electrical stimuli of 2000 mu duration, ranging from 0.5 to 35 mA (ampere) was administered one per second in 0.5 mA increments. Participants were instructed to indicate when they first felt the slightest sense of pain (electrical pain threshold, EPTh) and when they were unable to tolerate a further increase (electrical pain tolerance, EPTo). For each measure, the average of three trials was computed for use in subsequent analyses. Each of the three electrical pain stimuli were presented three times and balanced in order using a Graeco-Latin square design. The pain scale is between 0 and 10, with 0 being no pain and 10 being the worst pain imaginable|Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion||||units on a scale||Standard Error|Mean
1231027|NCT00657358|Primary|Ischemic Pain|The right arm was exsanguinated by elevating it above heart level for 30 seconds, after which the arm was occluded with a standard blood pressure cuff positioned proximal to the elbow inflated to twice the participant’s mean arterial pressure. Participants then performed 20 handgrip exercises of 2-second duration at 4-second intervals at 50% of their maximum grip strength. Pain was rated on a scale from 0 - 10 with 0 being no pain to 10 being the worst pain imaginable.|baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion|health volunteers|||units on a scale||Standard Error|Mean
1231028|NCT00657280|Secondary|Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.|4 years|||||||
1231029|NCT00657280|Secondary|Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy||2010-2012|||||||
1231030|NCT00657280|Primary|Determine the Effects of Sitagliptin on Myocardial Glucose Uptake in Patients With Nonischemic Cardiomyopathy|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.|2008-2012|||||||
1231031|NCT00657280|Primary|Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. Baseline glucose uptake scans will be compared with the scans on sitagliptin thirty days after baseline|30 days|Scans were lost in 4 participants|||SUV||Full Range|Mean
1231032|NCT00657267|Secondary|Time to Progression.|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|From patient registration until end of study, assessed up to 54 months|Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.|||days||95% Confidence Interval|Median
1231033|NCT00657267|Secondary|Radiographic Response|Responders on study are those with a best response of either CR or PR. Per Modified Macdonald Criteria for lesions assessed by MRI/CT: Complete Response (CR) = Complete disappearance of all measurable and evaluable disease, no new lesions, no evidence of non-evaluable disease, with no steroids. Partial Response (PR) >/= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, no new lesions, with steroid dose @ time of response </= max dose w/in the first 8 weeks of therapy.|From patient registration until end of study, assessed up to 54 months|Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.|||percentage of participants evaluated|||Number
1231034|NCT00657267|Secondary|Overall Survival||From patient registration until end of study, assessed up to 54 months|Entire study population|||months||95% Confidence Interval|Median
1231035|NCT00657267|Primary|6 Month Progression Free Survival|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|Patients evaluable for imaging analysis, as protocol-defined.|||percentage of evaluable participants|||Number
1231036|NCT00657150|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients|||participants|||Number
1231037|NCT00657150|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1|Treated and operated patients|||mL||Standard Deviation|Mean
1231038|NCT00657150|Secondary|Blood Transfusion|Number of treated and operated patients with required blood transfusion on day of surgery.|Day 1|Treated and operated patients|||participants|||Number
1231089|NCT00656799|Secondary|Vital Sign: Mean Systolic Blood Pressure|Systolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex|||mm Hg||Standard Deviation|Mean
1231039|NCT00657150|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|28-35 days|All patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication.|||Participants|||Number
1231040|NCT00657150|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up|||Participants|||Number
1231041|NCT00657150|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)|||Participants|||Number
1231042|NCT00657150|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)|||Participants|||Number
1231043|NCT00657150|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)|||Participants|||Number
1231044|NCT00657150|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|28-35 days|Full Analysis Set-tDVT (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT.)|||Participants|||Number
1231045|NCT00657150|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - pDVT (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery (i.e. a date of surgery was reported), evaluable negative venogram for proximal DVT in both legs or positive venogram in either leg or confirmed symptomatic proximal DVT)|||Participants|||Number
1231046|NCT00657150|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|28-35 days|Full Analysis Set-major (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for proximal DVT in both legs or a positive venogram for proximal DVT in either leg or confirmed symptomatic proximal DVT, PE or death related to VTE during the treatment period.)|||Participants|||Number
1231047|NCT00657150|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|28-35 days|Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.)|||Participants|||Number
1231048|NCT00657046|Post-Hoc|Number Patients With Hypotension Induced Early Termination of Dialysis Procedure||6 weeks|Patients had to have at least one post baseline visit (visit 8 and beyond).|||participants|||Number
1231049|NCT00657046|Other Pre-specified|Change in Systolic Blood Pressure From Pre-dialysis to Post-dialysis|"Change from baseline (visits 2-7) to end of study (HD visits 14-19) in the drop in systolic blood pressure from pre-hemodialysis to 5 minutes post-hemodialysis.~The baseline value was the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value was defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 timeframe.|||mmHg||Standard Deviation|Mean
1231050|NCT00657046|Post-Hoc|Systolic Blood Pressure Difference Between Pre-Hemodialysis and Nadir|Change from baseline to end of study (HD visits 14-19) in systolic blood pressure difference between pre-hemodialysis and nadir.|6 weeks|Patients must have completed visits in the visit 14-19 timeframe. One droxidopa 400 mg patient did not have the required nadir blood pressure information for visits 14-19 and was excluded from the analysis.|||mmHg||Standard Deviation|Mean
1231320|NCT00654745|Secondary|Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment|24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP|week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)||||mm Hg||Standard Error|Mean
1231051|NCT00657046|Secondary|Change in the Multidimensional Fatigue Inventory (MFI-20)|"Fatigue will be measured by the general fatigue domain (items 1, 5, 12 and 16) of MFI-20 and will be summarized by treatment group and treatment period. The scores per item run from 1 to 5. A higher score indicates more fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). This concerns item: 5 and 16. A total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20.~The value at baseline (visit 7) will be subtracted from the value on treatment (visit 19 or visit 13 if visit 19 is not available)."|6 weeks|Patients must have completed at least visit 14. Three placebo patients did not complete their Multidimensional Fatigue Inventory during this visit.|||units on a scale||Standard Deviation|Mean
1231052|NCT00657046|Secondary|Daily Symptoms Associated With Hemodialysis|"The Daily symptoms associated with hemodialysis score is the sum of an 8 question scale (each rated 0 [asymptomatic] to 4 [severe]). The questions look at fatigability, malaise/weakness, physical disturbance on standing, coldness of limbs, dizziness/lightheadedness, dizziness on standing, general bad feeling, and sleep disorders and asks how each of these items affected the patients daily activities on that day.~The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 timeframe. Three placebo patients and one droxidopa 600mg patient did not complete their Daily Symptoms Assessments during these visits.|||units on a scale||Standard Deviation|Mean
1231053|NCT00657046|Secondary|Change in the Hypotension-induced Symptom Severity Score|"The hypotension-induced symptom severity score is the sum of a 6 question scale (each rated 0 [asymptomatic] to 4 [severe]). The questions look at cramps, dizziness, headache, nausea, itchiness, and restless legs syndrome experienced during dialysis.~The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 time frame.|||units on a scale||Standard Deviation|Mean
1231054|NCT00657046|Secondary|Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;|Evaluate the efficacy of droxidopa as measured by change in the number of hypotension-induced interventions during hemodialysis (HD) sessions between baseline (visits 2-7) and treatment (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).|6 weeks|Patients must have completed visits in the visit 14-19 timeframe.|||average interventions per session||Standard Deviation|Mean
1231055|NCT00657046|Secondary|Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;|Change between baseline (visits 2-7) and treatment (visits 14-19) in average mean nadir systolic blood pressures during hemodialysis. The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).|6 weeks|Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.|||mmHg||Standard Deviation|Mean
1231056|NCT00657046|Primary|Change in Average Mean Arterial Blood Pressure During Hemodialysis|"Change between average baseline (visits 2-7) mean arterial blood pressure during hemodialysis and average treatment (visits 14-19) mean arterial blood pressure during hemodialysis.~The calculation of MAP was based on the systolic (SBP) and diastolic (DBP) blood pressure measurements taken during each valid HD session, using the traditional formula:~MAP = (SBP+2*DBP)/3 for each time-point. The mean of the intradialytic measurements was calculated for each valid HD session, and these daily mean values were averaged across the visits within each period."|6 weeks|Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.|||mmHg||Standard Deviation|Mean
1231057|NCT00657020|Secondary|Mean Percentage of Correct Responses During DIA Task|Mean percentage of correct responses during DIA task was determined.|Approximately 2 hours post dose administration|Number of subjects with complete imaging data on both treatments (nicotine and placebo)|||Percentage of responses correct||Standard Deviation|Mean
1231058|NCT00657020|Secondary|Mean Response Time for Correct Responses During DIA Task|"DIA task comprised of three conditions: i) Sustained visual attention wherein participant responded to letter s every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number 8 each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of s (visual) and 8 (auditory) simultaneously. Mean response time for correct responses was determined."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||msec||Standard Deviation|Mean
1231059|NCT00657020|Secondary|Percent Mean Change in BOLD Scores During Divided Attention (DIA) Task|"BOLD fMRI signals evaluated different brain ROIs during DIA task which comprised of three conditions: i) Sustained visual attention wherein participant responded to letter s every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number 8 each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of s (visual) and 8 (auditory) simultaneously. Brain ROIs were right and left parietal cortex, visual cortex, superior occipital cortex and right premotor cortex."|Approximately 2 hours post dose admininstration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||Percentage change in BOLD signal||Standard Deviation|Mean
1231060|NCT00657020|Secondary|Mean Percentage of Correct Responses During RVIP Task|Percentage of correct responses during RVIP task was determined|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||Percentage of responses correct||Standard Deviation|Mean
1231062|NCT00657020|Primary|Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Rapid Visual Information Processing (RVIP) Task|In RVIP task, participant responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participant responded to single occurrences of the number “0”. BOLD fMRI signals evaluated different brain regions of interest (ROI) during RVIP task. Brain ROIs identified were right and left anterior insula, anterior putamen, parietal cortex, premotor cortex, visual cortex, dorsal anterior cingulate cortex, substantia nigra and thalamus.|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||Percentage change in BOLD signal||Standard Deviation|Mean
1231063|NCT00656968|Primary|Number of Participants Who Had Good Drug Compliance|Good drug compliance is defined as taking equal to or more than 80% of eradication medicines|one month after finishing test therapy||||participants|||Number
1231064|NCT00656968|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|one month after finishing study drugs||||participants|||Number
1231065|NCT00656916|Primary|Lung Function Non-deterioration Rate|Lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of < 20%. FEV1, maximal amount of air forcefully exhaled in 1 second, converted to percentage of normal, calculated from a pulmonary function test (PFT) performed at baseline and three months.|Baseline and three months|There was no analysis performed for the protocol due the low enrollment (one participant).|||Percentage (FEV1|||Number
1231066|NCT00656851|Secondary|Fasting Glucose Insulin and HOMA|fasting plasma glucose, insulin concentrations and HOMA-insulin resistance|Week 0 and 16||||mg/dL µU/mL||Standard Error|Mean
1231067|NCT00656851|Secondary|Fasting Lipids and Lipoproteins|fasting serum triglycerides, LDL-, and HDL-cholesterol concentrations|Week 0 and 16||||mg/dL||Standard Error|Mean
1231068|NCT00656851|Primary|Myocardial Fatty Acid Esterification|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid esterification as a % of total fatty acid extraction|Weeks 0 and 16||||(% of total fatty acid extraction)||Standard Error|Mean
1231069|NCT00656851|Primary|Myocardial Fatty Acid Oxidation Rate|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid oxidation rate.|Weeks 0 and 16||||(nmol palmitate/g heart muscle/min||Standard Error|Mean
1231070|NCT00656851|Primary|Myocardial Fatty Acid Utilization Rate|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid utilization rate. The rate at which palmitate exits the blood, enters the muscle cells in the left ventricle, and is metabolized (oxidation, re-esterification).|Weeks 0 and 16||||(nmol palmitate/g heart muscle/min||Standard Error|Mean
1231071|NCT00656851|Primary|Myocardial Glucose Utilization Rate Per Unit Insulin|Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate per unit of plasma insulin. Total glucose utilization rate in the left ventricle of the heart expressed per unit of the circulating plasma insulin concentration.|Weeks 0 and 16||||(nmol glucose/g heart muscle/min/µU insu||Standard Error|Mean
1231072|NCT00656851|Secondary|Myocardial Contractile Function During Systole|Echocardiographic quantification of E' wall velocity during systole averaged at the lateral wall and septum|Weeks 0 and 16||||cm/sec||Standard Error|Mean
1231073|NCT00656851|Secondary|Myocardial Contractile Function During Diastole|"Echocardiographic quantification of (E/A) early to late diastolic filling velocity. Aria transfer blood to the ventricles in 2 steps:~blood collected in the atria falls into the ventricles when the atrioventricular valves opens. In the left heart, the velocity at which the blood moves during this initial action is called the early or E filling velocity.~residual blood in the atria, is emptied during diastole by atrial contraction. The velocity of the blood during atrial contraction is the A (for atrial) filling velocity. These are expressed as a ratio (E/A). If A exceeds E velocity (ratio <1.0) this is a clinical marker of diastolic dysfunction. This can occur when the left ventricular wall becomes so stiff as to impair proper filling, which can lead to diastolic heart failure."|Weeks 0 and 16||||ratio||Standard Error|Mean
1231074|NCT00656851|Primary|Myocardial Glucose Utilization Rate|Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate. The rate at which glucose exits the blood, enters the muscle cells in the left ventricle, and is metabolized (ATP generation, glycolysis, glycogenolysis, or lactate production). Total glucose utilization rate in the left ventricle of the heart.|Weeks 0 and 16||||(nmol glucose/g heart muscle/min||Standard Error|Mean
1231075|NCT00656799|Primary|Rate of Clearance of Rocuronium From Dialysate|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||mL/min||Standard Deviation|Mean
1231076|NCT00656799|Primary|Rate of Clearance of Sugammadex From Dialysate|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||mL/min||Standard Deviation|Mean
1231090|NCT00656799|Secondary|Number of Participants With Medical Device (Near) Incidents|A medical device (near) incident is defined as an occurrence due to inaccurate or inadequate labeling/instructions, or information supplied with a medical device; or malfunction, deterioration or recall of a medical device that could lead to death or serious deterioration in health.|Up to day 7|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
1231077|NCT00656799|Primary|Rate of Clearance of Rocuronium From Blood|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||mL/min||Standard Deviation|Mean
1231078|NCT00656799|Primary|Rate of Clearance of Sugammadex From Blood|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||mL/min||Standard Deviation|Mean
1231079|NCT00656799|Primary|Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR)|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||Reduction Ratio||Standard Deviation|Mean
1231080|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.7. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement|||Minutes||95% Confidence Interval|Geometric Mean
1231081|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.8. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement|||Minutes||95% Confidence Interval|Geometric Mean
1231082|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|Intent To Treat (ITT) group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement|||Minutes||95% Confidence Interval|Geometric Mean
1231083|NCT00656799|Secondary|Number of Participants With Pregnancies at 30 Days Post-dose|Pregnancies reported by means of a Pregnancy Reporting Form, consist of pregnant female participants or pregnant female partners of male participants|Up to 30 days post -dose|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
1231084|NCT00656799|Secondary|Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium|Evidence of AEs due to possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium|Day 1|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
1231085|NCT00656799|Secondary|Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1|Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. Reoccurrence of neuromuscular blockade is defined as a decline in the T4/T1 ratio from >= 0.9 to < 0.8 in at least three consecutive measurements.|Day 1|AST consisting of all screened participants who received a dose of sugammadex|||participants|||Number
1231086|NCT00656799|Secondary|Number of Participants With Physical Examinations|Physical examinations were to be conducted at screening, on Day 1 and 7 days after surgery|Screening up to day 7|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
1231087|NCT00656799|Secondary|Vital Sign: Mean Heart Rate|Heart rate was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex|||Beats per minute||Standard Deviation|Mean
1231088|NCT00656799|Secondary|Vital Sign: Mean Diastolic Blood Pressure|Diastolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex|||mm Hg||Standard Deviation|Mean
1231091|NCT00656799|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A SAE is any untoward medical occurrence that at any dose results in the following: death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or is a congenital anomaly/birth defect|Up to day 7|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
1231092|NCT00656799|Secondary|Number of Participants With Pre-treatment Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body, whether or not related to the use of a product.|Screening up to Day 1|All Subjects Treated (AST) consisting of participants who received a dose of sugammadex|||participants|||Number
1231093|NCT00656799|Primary|Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||Reduction Ratio||Standard Deviation|Mean
1231094|NCT00656669|Secondary|To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy|This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib.|end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy)|All patients who were on paclitaxel plus sunitinib.|||participants|||Number
1231095|NCT00656669|Secondary|Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer||screening through surgery|All patients who had surgery.|||percentage of participants||95% Confidence Interval|Number
1231096|NCT00656669|Secondary|Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy|Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value.|end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days)|All patients in the paclitaxel plus sunitinib segment|||mm Hg||Standard Deviation|Mean
1231097|NCT00656669|Primary|Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy|Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.|baseline through end of segment 1 (2 weeks)|All patients that had both measures at baseline and endpoint in the sunitinib monotherapy segment|||mm Hg||Standard Deviation|Mean
1231098|NCT00656656|Secondary|Number of Patients Who Experienced Side-effects of Treatment|Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.|up to 43 months||||Participants|||Count of Participants
1231099|NCT00656656|Primary|Number of Patients Achieving a Short- and Long-term Remission of Pemphigus|Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.|up to 43 months||||Participants|||Count of Participants
1231100|NCT00656630|Secondary|Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1|The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score.|2 weeks|One participant in the naltrexone arm who completed the double blind portion of the trial was unable to be analyzed for change in ACQ-SF Total score due to incomplete ACQ-SF questionnaire at Week 1.|||units on a scale||Standard Deviation|Mean
1231101|NCT00656630|Secondary|Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1|The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score.|1 week|Seven participants who completed the double blind portion of the trial were unable to be analyzed for change in PSQI Total score due to incomplete PSQI questionnaire at baseline and/or Week 1.|||units on a scale||Standard Deviation|Mean
1231102|NCT00656630|Secondary|Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1|The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3.|1 week||||units on a scale||Standard Deviation|Mean
1231103|NCT00656630|Secondary|Change From Baseline in Standard Drinks Per Week at 1 Week|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.|1 week||||drinks/week||Standard Deviation|Mean
1231104|NCT00656630|Primary|Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period|The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.|1 week||||units on a scale||Standard Deviation|Mean
1234098|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||unit per liter [U/L]||Full Range|Median
1231105|NCT00656617|Secondary|Participant Response|Number of participants with response assessed according RECIST: Complete Response (CR) defined as normalization of marrow (< 5% blasts) and of peripheral blood counts (neutrophil count > 1.109/L, platelet count > 100 x 109/L). Partial response (PR) defined as for CR in terms of peripheral counts but with reduction of marrow blasts by >50% compared to pretreatment values but above <5%. Complete Response without platelet recovery (CRp) = CR, but platelets <100 x 109/L. Progressive disease (PD) defined as increase of blasts to > 10% after an initial response.|Monitoring with each 4 week cycle, up to 18 cycles of treatment|Four (4) participants were not treated therefore not evaluable for the outcome assessment.|||participants|||Number
1231106|NCT00656617|Primary|Progression Free Survival (PFS) at 7 Months|Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.|PFS Evaluation at 7 months|Four (4) participants did not receive treatment therefore were not evaluable for outcome assessment.|||percentage of participants|||Number
1231107|NCT00656513|Secondary|Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III|The UWHNSS includes ten categories—pain, disfigurement, activity, recreation/entertainment, employment, eating, saliva, taste, speech, mucus/phlegm. Patient scores on the UWHNSS range from 0 to 100 with higher scores indicating declining quality of life. Change in total score was calculated by subtracting baseline from follow-up , thus a positive change score indicates a worsening while a negative change score indicates an improvement.|Baseline and 9 months from randomization.|Eligible randomized patients with both baseline and 9-month UWHNSS total scores.|||units on a scale||Inter-Quartile Range|Median
1231108|NCT00656513|Secondary|Change From Baseline in Unstimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)|Basal whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.|Pre-treatment to 4, 6, 9 and 15 months from randomization|Eligible randomized patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.|||ml/min||Inter-Quartile Range|Median
1231109|NCT00656513|Secondary|Change From Baseline in Stimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)|Stimulated (citric acid primed) whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. Stimulation is elicited by asking patients to rinse 5 ml of 2% citric acid solution in the mouth for 15 seconds and then completely expectorating the citric acid. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.|Baseline, 4, 6, 9 and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.|||ml/min||Inter-Quartile Range|Median
1231110|NCT00656513|Secondary|Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III)|Symptom burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning. The domain score is the average of all responses on a given domain and can range from 0 to 4, with higher scores indicating increased symptom burden. Change in symptom burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the symptom burden.|Baseline, 4, 6, 9 and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) XeQOLS scores.|||units on a scale||Inter-Quartile Range|Median
1231111|NCT00656513|Secondary|Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III)|Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.|Baseline, 4, 6, and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6,15 months) XeQOLS scores.|||units on a scale||Inter-Quartile Range|Median
1231112|NCT00656513|Secondary|Phase II: Pecentage of Patients With Beneficial Treatment Response|This secondary objective was to evaluate the effect of ALTENS treatment on overall radiation-induced xerostomia burden by looking at treatment response. Treatment response was determined by a reduction of at least 20% from baseline to 6 months in the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4. Higher scores indicate increased xerostomia burden. This scale has high reproducibility and sensitivity. For the first and second stage analyses, 4 and 10 patients, respectively, must respond to treatment in order to proceed to the phase III component.|Pre-treatment and 6 months from registration|Eligible patients who started treatment and have both baseline and 6-month XeQOLS scores|||percentage of participants||95% Confidence Interval|Number
1231150|NCT00656058|Secondary|Percentage Overall 2-Year Survival|Percentage of participants alive at 2 years.|2 years|This is a multicenter study and the number analyzed reflect data for evaluable subjects enrolled at the National Institutes of Health only.|||percentage of participants|||Number
1231113|NCT00656513|Primary|Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months|Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.|Baseline (randomization) and 9 months|Eligible randomized patients with both baseline and 9 month XeQOLS scores|||units on a scale||Inter-Quartile Range|Median
1231114|NCT00656513|Primary|Phase II: Treatment Compliance (Number of Compliant Patients)|Patients completing at least 19 out of 24 ALTENS therapy sessions were categorized as compliant. Fleming’s two-stage was used, assuming a successful target compliance rate of 80%, statistical power of 0.87, and a type I error rate of 0.13. If fewer than 9 of the first 13 patients were compliant, then treatment delivery will be deemed not feasible. If there were between 9-12 compliant patients, the second stage analysis would be required to determine feasibility of treatment delivery. If all 13 patients are compliant, treatment delivery will immediately be deemed feasible. The second stage analysis required at least 31 compliant out of 39 overall patients for the treatment delivery to be deemed feasible.|Randomization to 12 weeks|Eligible patients starting protocol treatment|||Participants|||Count of Participants
1231115|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Mean Time To First Response at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Mean Time To First Response is a measure of latency and is unbounded. Change = (Day 28 Time - Day 0 Time). A more negative result indicates greater improvement.|Day 0 and Day 28||||milliseconds||Standard Deviation|Mean
1231116|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Total Errors are a measure of performance and are unbounded. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.|Day 0 and Day 28||||units on a scale||Standard Deviation|Mean
1231117|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Strategy Score is an estimate of use of the most efficient strategy to complete the task. Scores range from 8-56; higher scores equate to poor use of the most efficient strategy. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.|Day 0 and Day 28||||units on a scale||Standard Deviation|Mean
1231118|NCT00656487|Primary|Plasma Cortisol|Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.|Day 28|Two control participants and one placebo participant who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. The control participants did not have blood drawn; the placebo participant returned a non-detectable value.|||ug/dL||Standard Deviation|Mean
1231119|NCT00656487|Primary|Plasma Norepinephrine|Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.|Day 28|Five control participants who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. Two participants did not have blood drawn; two additional participant sample results were not returned by the laboratory; and one participant did not return a result due to an ELISA kit error.|||ng/mL||Standard Deviation|Mean
1231120|NCT00656487|Primary|Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period|The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal.|Day 28|One participant in the control group who completed monitoring during the double-blind portion of the trial did not complete a Marijuana Withdrawal Checklist at Day 28.|||units on a scale||Standard Deviation|Mean
1231121|NCT00656474|Secondary|Percentage of Wound Epithelialized|The percentage of wound epithelialized was assessed at Day 15 post laser ablation.|Day 15 post laser ablation.|Analysis was Per Protocol.|||percent|||Number
1231122|NCT00656474|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.|||days||95% Confidence Interval|Median
1231123|NCT00656448|Secondary|Number of Participants With Complete Remission|International Working Group (IWG) criteria for responses defined as: Complete Remission (CR) - Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); Partial remission (PR): as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%.|After 1 course of therapy, one course is 4 weeks.||||participants|||Number
1231124|NCT00656448|Primary|Median Number of Participant Transfusions Required During 12 Weeks of Treatment|"The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group (Procrit) and standard care group (No Procrit). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period."|12 weeks||||Transfusions per Participant||Full Range|Median
1231125|NCT00656370|Secondary|Number of Participant's With the Indicated Global Preference for Infusion (Left Versus Right Thigh)|Participants blinded to the type of infusion were asked to state their preference for the left or right infusion following all infusion day (Day 1) activities and assessments. The preference for the left or right infusion indicated which infusion was preferred: NS or LR.|End of infusion (Day 1)|15 participants were randomized and completed stage 1|||Participants|||Count of Participants
1231126|NCT00656370|Secondary|Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference|Thigh circumference was measured at the level of the angiocatheter with a flexible measuring tape prior to infusion initiation (Baseline), at the midpoint for each infusion, and at the end of each infusion.|Before the infusion (Baseline) until discharge (Day 1)|15 participants were randomized and completed stage 1. Only those participants who experienced a 5% or greater increase in thigh circumference for both infusions were included in the analysis.|||minutes||Standard Deviation|Mean
1231127|NCT00656370|Secondary|Percent Change From Baseline Thigh Circumference to Maximum Post-Baseline Thigh Circumference at Infusion Sites|Thigh circumference was measured in centimeters at 7 time points before, during, and after subcutaneous infusion of 500 mL NS or LR solution.|Before the infusion, during the infusion, after the infusion, and discharge (Day 1)|15 participants were randomized and completed stage 1|||percent change||Standard Deviation|Mean
1231128|NCT00656370|Secondary|Average Infusion Flow Rate (Milliliters Per Hour [mL/hr]) Derived From the Time to Infuse up to 500 mL of Solution|The infusion flow rate (mL/h) was derived from the time to subcutaneously (SC) infuse up to 500 mL of NS or LR solution (following SC injection of 150 Units hylenex) by measuring the change in weight of the infusion bag, fluid, and tubing.|During infusion on Day 1|15 participants were randomized and completed stage 1|||mL/hr||Standard Deviation|Mean
1231129|NCT00656370|Secondary|Number of Participants Assessed for Safety Measures|Safety outcome measures included adverse events (AEs), physical examinations (targeted physical examination included lung auscultation for rales, checking for edema, evaluation of infusion sites, positives on a review of systems, and follow-up of findings from previous physical examinations), and vital signs (systolic blood pressure, diastolic blood pressure, heart rate, and respiration rate).|Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left (up to approximately 8 days)|15 participants were randomized and completed stage 1|||participants|||Number
1231130|NCT00656370|Primary|The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)|Participant's self-assessment of discomfort at the infusion site by means of a validated VAS with a range of 0 millimeters (mm) (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of normal saline (NS) versus Lactated Ringer's (LR), each following an SC slow-push injection of 150 Units (U) Hylenex.|Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes on Day 1|15 subjects were randomized and completed stage 1|||mm||Standard Deviation|Mean
1231131|NCT00656305|Secondary|Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline|The BPI-QOL questionnaire is designed to show the severity and interference of pain in the lives of patients. This is a 7-item questionnaire that asks respondents the extent to which pain interferes with their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life using a 0-10 numerical rating scale in which 0 represents ‘does not interfere’ and 10 indicates ‘completely interferes’. Responses to the 7 items are averaged to form the pain interference scale score. Lower scores are better, showing less interference in daily activities while higher scores show more interference and hence worse outcomes.|3 months post treatment|115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.|||score on a scale||Standard Deviation|Mean
1231132|NCT00656305|Secondary|Number of Participants With a Change in Medication Use|"Medication Use change reported from baseline until of study. Medication use is quantified by morphine equivalent usage (measured separately from Responder/Non-responder definition for the primary endpoint)"|3 months post treatment|Only 26 of the 81 subjects in ExAblate treatment arm and 6 of 26 in the sham arm were taking non-opioid medication at baseline.|||Participants|||Count of Participants
1231133|NCT00656305|Primary|Number of Responders|Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), each subject was rated as a Responder or Non-responder. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use.|3 months post treatment|115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.|||Participants|||Count of Participants
1231134|NCT00656292|Secondary|Median Concentration of Tumor Necrosis Factor-Alpha (TNF)|Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||pg/ml||Inter-Quartile Range|Median
1231135|NCT00656292|Secondary|Median Concentration of Interleukin-6 (IL-6)|Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||ng/ml||Inter-Quartile Range|Median
1231136|NCT00656292|Secondary|Median Concentration of Creatine Kinase (CK)|A creatine kinase test may be used to detect inflammation of muscles or muscle damage due to muscle disorders. A person may have muscle injury with few or nonspecific symptoms, such as weakness, fever, and nausea, that may also be seen with a variety of other conditions. A healthcare practitioner may use a CK test to help detect muscle damage in these cases, especially if someone is taking a drug such as a statin. Normal values at rest are usually between 60 and 174 IU/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||U/L||Inter-Quartile Range|Median
1231137|NCT00656292|Secondary|Median Concentration of C-Reactive Protein (CRP)|C-reactive protein (CRP) is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||mg/L||Inter-Quartile Range|Median
1231138|NCT00656292|Secondary|Median Concentration of Alanine Aminotransferase (ALT)|An enzyme normally present in liver and heart cells that is released into the bloodstream when the liver or heart is damaged. The blood ALT levels are elevated with liver damage (for example, from viral hepatitis) or with an insult to the heart (for example, from a heart attack). The normal range is 7 to 56 U/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||U/L||Inter-Quartile Range|Median
1231139|NCT00656292|Primary|Median Concentration of Aspartate Aminotransferase (AST)|Description: AST is an enzyme found in high amounts in liver, heart, and muscle cells. This test is mainly done along with other tests such as alkaline phosphatase and bilirubin to diagnose and monitor liver disease. This test evaluates hepatocyte integrity, as serum levels of this enzyme rise in response to a variety of forms of injury to hepatic cells. The normal range is 10 to 40 U/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||U/L||Inter-Quartile Range|Median
1231140|NCT00656201|Primary|Percentage of Pregnant Patients After IVF Treatments|Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval|16 weeks|Number of participants for analysis was determined by completion of the IVF cycle using the specified medications, either Crinone or IM Progesterone|||percentage of participants|||Number
1231141|NCT00656175|Primary|Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)|Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm^2, not cm^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.|Baseline and 24 weeks||||cm^2||Inter-Quartile Range|Median
1231142|NCT00656136|Secondary|Objective Response Rate (OR)|OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.|From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.|||Percentage of patients with OR||95% Confidence Interval|Number
1231143|NCT00656136|Secondary|Progression-free Survival (PFS)|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.|||Months||95% Confidence Interval|Median
1231144|NCT00656136|Primary|Overall Survival|"Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock.~For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010.~For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013."|From randomization until death or the last patient out date, an average of 12 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.|||Months||95% Confidence Interval|Median
1231145|NCT00656084|Secondary|Progression-free Survival Rate at 1 Year.|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|1 year.|ITT population|||Probability of Progression-free Survival||95% Confidence Interval|Number
1231146|NCT00656084|Secondary|Overall Survival (OS) Rate at 1 Year|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|1 year.|ITT population|||Probability of Survival||95% Confidence Interval|Number
1231147|NCT00656084|Secondary|Duration of Response|"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.~CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|||months||Full Range|Median
1231148|NCT00656084|Primary|Objective Response Rate (CR + PR)|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|Evaluable Population|||percentage of participants||95% Confidence Interval|Number
1231149|NCT00656058|Secondary|Number of Non-Infected Participants at Baseline With Cysteinyl Leukotriene Receptor Expression on Cluster of Differentiation (CD4) and CD8 T Cells, Granulocytes, and Eosinophils in Bronchoalveolar Lavage (BAL) Fluid|Fluid from the bronchoalveolar lavage in adult participants (pediatric optional) will be collected and sent to the lab to be evaluated for infectious diseases by flow cytometry|Day 1 of study||||Participants|||Count of Participants
1231151|NCT00656058|Secondary|Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC)|Pulmonary function test performed for eligibility and baseline.|Baseline||||Ratio||Full Range|Median
1231153|NCT00656058|Primary|Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months|FEV-1 slope of decline was generated using regression line of FEV-1 value vs. days post hematopoietic stem cell transplant. Responsive disease (RD) for the slope of FEV-1 change will be an increase in the slope of absolute FEV-1. Progressive disease (PD) for the slope of FEV-1 change will be a decrease in the slope of absolute FEV-1. Stable disease (SD) for the slope of FEV-1 change will be a 0 change in FEV-1 slope.|180 days||||Participants|||Count of Participants
1231154|NCT00656058|Primary|Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature|Responsive disease (RD) will be defined as ≥15% absolute improvement in the percentage predicted FEV-1. Progressive disease (PD) will be defined as >15% decrease in FEV-1 documented on 2 pulmonary function test (PFT) evaluations greater than 2 weeks apart. Stable disease (SD) will be defined as <15% change in the absolute FEV-1.|180 days|No data is available for the one missing participant.|||Participants|||Count of Participants
1231155|NCT00656019|Primary|Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer|Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes|10 days to 4 weeks post diagnosis.||||percentage of participants|||Number
1231156|NCT00655889|Primary|Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)|A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.|Baseline (prior to first study treatment) compared to six months after first treatment|Subjects who received at least one treatment during the study were included in the Intent to Treat population|||participants|||Number
1231157|NCT00655889|Primary|Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)|A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.|Baseline (prior to first study treatment) compared to six months after first treatment|Subjects who received at least one treatment during the study were included in the Intent to Treat population|||participants|||Number
1231158|NCT00655876|Secondary|Quality-adjusted Survival (Using EQ-5D), Only if Primary Hypothesis is Supported|The protocol states that this study endpoint will be addressed ONLY if primary outcome results are positive, i.e. support the primary hypothesis of this study. The primary hypothesis was not supported therefore this outcome measure is not reported.|Baseline, 6-8 weeks after completion of chemoradiation, 1 year and 2 years from treatment start.|||||||
1231159|NCT00655876|Secondary|Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment|The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-68. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-E including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Improvement in FACT-E score is defined as an increase from baseline score of at least 5 points.|Baseline, 6-8 weeks after completion of chemoradiation , 1 year and 2 years from treatment start.|Patients who consented to collection of patient reported outcomes and quality of life (PRO-QOL) data and had FACT-E scores at baseline and corresponding timepoint|||percentage of participants|||Number
1231160|NCT00655876|Secondary|Endoscopic Complete Response Rate|All patients were to undergo a repeat endoscopy (EUS) 6-8 weeks after the completion of chemoradiation. At the time of EUS a visual inspection of the site of the original primary disease would be documented. Those patients found to be free of disease were NOT required to undergo repeat biopsy. These patients would be scored as clinical complete responses (cCR). Patients deemed to have residual disease or suspicion of residual disease would undergo a biopsy in order to pathologically confirm findings. Any patient with pathologically confirmed residual disease would be scored as a local failure. Patients who were pathologically proven to have no evidence of disease would be scored as cCRs.|From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks)|Eligible patients who started study treatment and had an endoscopy performed|||percentage of participants|||Number
1231161|NCT00655876|Secondary|Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events|Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE|From start of treatment to 90 days from end of treatment|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1231162|NCT00655876|Secondary|Local Failure (24-month Rate Reported)|Local failure (LF) was defined as residual cancer on posttreatment biopsy findings or biopsy-proven recurrent primary disease and local failure time was measured from randomization to failure or last follow-up. Nonprotocol surgery to the primary site with gross residual disease was considered a LF as of the surgery date. Patients with no viable disease or microscopic residual disease at nonprotocol surgery were censored for LF as of the surgery date. Local failure was estimated by the cumulative incidence method with death considered a competing risk.|From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.|All eligible patients|||percentage of participants||95% Confidence Interval|Number
1231351|NCT00654498|Primary|"The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved"|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.|6 weeks of treatment||||Proportion of Patients|||Number
1231163|NCT00655876|Primary|Overall Survival (24-month Rate Reported)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur after at least 281 deaths have been observed, unless an early stopping rule was satisfied.|From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.|"Eligible patients [We have defined completed as patients who have data available for analysis]"|||percentage of participants||95% Confidence Interval|Number
1231164|NCT00655863|Secondary|Change From Baseline in Endothelial Function Through Pulse Wave Tonometry|Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.|Baseline and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1231165|NCT00655863|Secondary|Change From Baseline in e-Selectin|The change in e-Selectin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||ng/mL||Standard Error|Least Squares Mean
1231166|NCT00655863|Secondary|Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)|The change in ICAM collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||ng/mL||Standard Error|Least Squares Mean
1231167|NCT00655863|Secondary|Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)|The change in VCAM collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||ng/mL||Standard Error|Least Squares Mean
1231168|NCT00655863|Secondary|Change From Baseline in Adiponectin|The change in adiponectin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||µg/mL||Standard Error|Least Squares Mean
1231169|NCT00655863|Secondary|Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)|The change in hs-CRP collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg/L||Standard Error|Least Squares Mean
1231170|NCT00655863|Secondary|Change From Baseline in Postprandial Proinsulin|The change in postprandial proinsulin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||pmol/L||Standard Error|Least Squares Mean
1231171|NCT00655863|Secondary|Change From Baseline in Postprandial C-Peptide|The change in postprandial C-peptide collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||ng/mL||Standard Error|Least Squares Mean
1231172|NCT00655863|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in fasting plasma glucose collected at each week indicated relative to baseline.|Baseline, Week 4, Week 8 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1231173|NCT00655863|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.|Baseline, Week 8 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1231174|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucagon|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||pg/mL||Standard Error|Least Squares Mean
1231416|NCT00653263|Primary|Methamphetamine Withdrawal Assessment (MAWA)|The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score).|Baseline through week 4||||"Units on a scale"||Standard Deviation|Mean
1231175|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Insulin|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||uIU/mL||Standard Error|Least Squares Mean
1231176|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucose|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1231177|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||pmol/L||Standard Error|Least Squares Mean
1231178|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.|Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg.h/dL||Standard Error|Least Squares Mean
1231179|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.|The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg.h/dL||Standard Error|Least Squares Mean
1231180|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.|The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.|Baseline and Week 4.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg.h/dL||Standard Error|Least Squares Mean
1231181|NCT00655863|Primary|Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.|The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.|Baseline and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg.h/dL||Standard Error|Least Squares Mean
1231182|NCT00655850|Secondary|Objective Response Rate|The percentage of patients who achieve a complete response and partial response according to RECIST criteria (v1.0).|Baseline up to 12 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.|||Participants|||Count of Participants
1231183|NCT00655850|Secondary|Overall Survival (OS)|Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences death or lost to follow up.|Baseline up to 84 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.|||months||Full Range|Median
1231184|NCT00655850|Secondary|Number of Participants With Adverse Events|All adverse events will be recorded as to the grade and relationship to the study drug in accordance with the Common Terminology Criteria for Adverse Events (CTCAE v 3.0)|Baseline through duration of treatment an average of 1 year|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.|||participants|||Number
1231185|NCT00655850|Primary|Progression-Free Survival (PFS)|Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences disease progression in accordance with the Response Evaluation Criteria Solid Tumors (RECIST v1.0). The RECIST criteria indicates progression as a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.|Baseline to 24 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.|||months||95% Confidence Interval|Median
1231186|NCT00655824|Secondary|Number of Participants With Normal and Abnormal Electrocardiogram Readings|Electrocardiograms of the participants were taken. The abnormal clinically significant (CS) and not clinically significant (NCS) reading, as determined by the Investigator, were recorded.|8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
1231470|NCT00653224|Secondary|Sneezing Score Over the Second Week|The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available sneezing score over Week 2|||points on a scale||Standard Deviation|Mean
1231187|NCT00655824|Secondary|Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK)|Blood samples of participants were collected to assess LDH and CPK. Both tests are performed to evaluate the injury and damage to the body tissue, potentially from B-cell lysis.|8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||U/L||Standard Deviation|Mean
1231188|NCT00655824|Secondary|Assessment of Body Temperature (BT)|The BT of the participants was measured BI and post the first (A) and second (B) infusions (PI) of each cycle to assess the effect of ofatumumab on the BT.The BT of the participants was measured before BI and PI A and B during all 7 treatment courses.Timing for taking BT reading: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.|||Degrees celcius||Standard Deviation|Mean
1231189|NCT00655824|Secondary|Assessment of Heart Rate (HR)|The HR of the participants was measured to assess the condition of the heart.HR was measured BI and post the first (A) and second (B) infusins during all 7 treatment courses.Timing for measuring HR: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
1231190|NCT00655824|Secondary|Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The blood pressure (BP) of the participants was measured before infusion (infu) (BI) and post the first (A) and second (B) infusions (PI) during all 7 treatment courses.Timing for taking BP readings: SBP (BP when the heart is contracting): TC1, 2, 3 (infu A) more than 2 hours PI; TC1, 2 ,3 (infu B) 2 hours PI; TC4, 5, 6, 7 (infu A) 2 hours PI; TC4, 7 (infu B) 2 hours PI; TC5, 6 (infu B) 1 hour PI. For DBP (BP when the heart is resting between beats): TC1, 3 (infu A) more than 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC1, 2, 3, 4, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1231191|NCT00655824|Secondary|Assessment of Blood Urea Nitrogen (BUN)|The blood samples of participants were collected to assess the amount of nitrogen (in the form of urea) in the blood. BUN is evaluated to asssess the renal function of the participants.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||millimoles per liter||Standard Deviation|Mean
1231192|NCT00655824|Secondary|Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT)|Blood samples of participants were collected for the evaluation of ALT, AST, AP, and GGT. AST, ALT, AP, and GGT are evaluated to assess the condition of the liver.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Units per liter (U/L)||Standard Deviation|Mean
1231193|NCT00655824|Secondary|Assessment of Total Bilirubin (TB) and Creatinine|Blood samples of participants were collected to evaluatate TB and creatinine levles. TB evlauation is performed to assess the condition of the liver, and possible hemolytic anemia, and the creatinine evaulation is performed to assess the renal condition (condition of the kidneys).|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Micromoles per liter (umol/L)||Standard Deviation|Mean
1231194|NCT00655824|Secondary|Assessment of Total Protein (TP) and Albumin|Blood samples of participants were collected to evaluate TP and albumin. TP can vary depending on auto-immune diseases, and TP and albumin can vary depending on debilitating diseases.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Grams/Liter (g/L)||Standard Deviation|Mean
1231195|NCT00655824|Secondary|Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid|Blood samples of participants were collected for the evaluation of uric acid and electrolytes (sodium, potassium, chloride, and calcium), as increased levels may reflect B-cell lysis due to treatment with ofatumumab.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Millimoles/liter (mmol/L)||Standard Deviation|Mean
1231196|NCT00655824|Secondary|Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter|Blood samples of participants were collected for the evaluation of IL-6. IL-6 plays an important role in immune response and helps assess the disease condition.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
1235165|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 24, ITT Population.||Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1231197|NCT00655824|Secondary|Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter|Blood samples of participants were collected for the evaluation of BLyS. BLyS is a potent co-stimulator of B lymphocytes, and elevated levels of BLyS are observed in automimmune diseases. It regulates the immunnoglobin (antibody produced by B cells that is used by the immune system to indentify bacteria and viruses in the body) secretion of normal B cells (type of cells in the blood).|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
1231198|NCT00655824|Secondary|Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter|Blood samples of participants were collected for the evaluation of Anti-CCP. Anti-CCP plays an important role in immune response and helps assess the disease condition.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
1231199|NCT00655824|Secondary|Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter|Blood samples of participants were collected for the evaulation of RA factor. RA factor is an antibody found in the blood of participants with rheumatoid arthritis and is used for the diagnosis of rheumatoid arthritis.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
1231200|NCT00655824|Secondary|Ratio of CD 4+/CD8+|Blood samples of participants were collected for the evaluation of CD4+ and CD8+ cell counts and the ratio was calculated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Ratio of CD 4+/CD8+ cells||Standard Deviation|Mean
1231201|NCT00655824|Secondary|CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3|Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ cell counts. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||cells per millimeters cubed (mm^3)||Standard Deviation|Mean
1231202|NCT00655824|Secondary|Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood|Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ B-cell subsets. These biomarkers are associated with immune functions.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Percentage of CD19+, 4+, 8+, and 3+ BCSs||Standard Deviation|Mean
1231203|NCT00655824|Secondary|Whole Blood Transcriptional Profiles|Blood samples were collected for transcriptomic analysis of messenger ribonucleic acid (mRNA). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231204|NCT00655824|Secondary|Number of Participants With HAHA Response|The host immune response was assessed based on Human Anti-Human Antibodies (HAHA). The serum samples of the participants were collected for the assessment of HAHA. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231205|NCT00655824|Secondary|Number of Participants With the Indicated Pain Score|"The pain score was assessed using the VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231206|NCT00655824|Secondary|Number of Participants With the Indicated Global Disease Assessment Using the VAS|The participant and the physician independantly used the VAS for overall assessment of the disease. VAS is used to measure the physician's subjective assessment of the participant's RA disease process at the time of the visit. The scale ranged from 0 (extremely well) to 10 (extremely poor). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231227|NCT00655733|Primary|The Efficacy of HMPL 004 Given at 1200 mg/Day, Assessed After 8 Weeks of Treatment With HMPL-004 in Inducing a Drop in the Subject's Crohn's Disease Activity Index (CDAI) by 100 Points.|For the Intention to Treat (ITT) population, the Worst Observation Carried Forward (WOCF) method, was used to measure the percentage of subjects in the HMPL 004 group as compared to the placebo group that achieved a clinical response of a CDAI reduction of 100 points at Week 8 as compared to the subject's entry level CDAI score.|8 weeks|The ITT population using the Worst Observation Carried Forward method.|||% Participants|||Number
1231207|NCT00655824|Secondary|Number of Participants in the Indicated Categories of the Health Assessment Questionnaire (HAQ)|The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The index is calculated by adding all scores, then dividing this score by the total number of components answered. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231208|NCT00655824|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response|EULAR response is based on the DAS score. EULAR response criterion classifies participants as good or moderate responders and non-responders. Good response: DAS28 score <=3.2 and >1.2 improvement from Baseline (IfB) in DAS28 score, Moderate response: DAS28 score <=3.2 and between >0.6 and <=1.2 IfB; DAS28 score between >3.2 and <=5.1 and >1.2 IfB; DAS28 score between >3.2 and <=5.1 and between >0.6 and <=1.2 IfB; DAS28 score >5.1 and >1.2 IfB. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231209|NCT00655824|Secondary|Number of Participants Achieving ACR70|ACR70 is achieved if the participant has 70% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from ‘no pain’ to ‘severe pain’ and the distance marked by the participant from the “no pain” end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231210|NCT00655824|Secondary|Number of Participants Achieving ACR50|ACR50 is achieved if the participant has 50% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from ‘no pain’ to ‘severe pain’ and the distance marked by the participant from the “no pain” end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TCand 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231211|NCT00655824|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)20|"ACR20 is achieved if the participant has 20% improvement from Baseline in TJC and SJC and in 3 out of 5 of following assessments (A); participant pain A, participant global A, physician global A on a visual analog scale (VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the “no pain” end is his joint pain score), participant self-assessed disability, and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
1231212|NCT00655824|Secondary|Ofatumumab Serum Concentration|Blood samples of participants were collected for the measurement of ofatumumab concentration in the blood. The blood samples were collected before infusion (BI) (baseline of that particular treatment course) and at the end of infusion (EI) of ofatumumab.|Before infusion and at the end of infusion for each Treatment Course (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next TC; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial vi|FAS Population. Only participants with data available at the particular time points were analyzed.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1231213|NCT00655824|Secondary|Time to Re-treatment in Each Treatment Course|Time to re-treatment in each treatment course (TC) is defined as the time from the first infusion of ofatumumab until the date of the first infusion of the first re-treatment course. The data presented reflect the time to re-treatment, which is defined as the time in days between the first infusion of each TC and the first infusion of the following TC. For TC 1, time to re-treatment is defined as the time between the first infusion in TC 1 and the first infusion in TC 2; similarly, for TC 2 it is the time between the first infusion of TC 2 and the first infusion of TC 3. The study was terminated by the sponsor after Treatment Course 7; therefore, there are no re-treatment data available for Treatment Course 7.|Week 16 to Week 104 of each treatment course (up to 125 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants available at the indicated time point were assessed.|||days||Standard Deviation|Mean
1231214|NCT00655824|Secondary|Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP)|DAS28(CRP) is a numeric outcome that measures RA activity based on the CRP (used to monitor acute inflammatory phases of RA), tender JC, swollen JC, and participant’s global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.|Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. One participant withdrew during the first infusion due to AEs of rash and pruritis. Only participants available at the indicated time point were assessed.|||scores on a scale||Standard Deviation|Mean
1231215|NCT00655824|Secondary|Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour)|DAS28(ESR) is a numeric outcome that measures RA activity based on the ESR (a non-specific general indicator of inflammation), tender joint count (JC), swollen JC, and participant’s global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.|Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. One participant withdrew during the first infusion due to adverse events (AEs) of rash and pruritus. Only participants available at the indicated time point were assessed. Minimum change from baseline is defined as the smallest change at any visit over the course of Weeks 1 to 24 of each treatment cycle.|||scores on a scale||Standard Deviation|Mean
1231216|NCT00655824|Primary|Time to Treatment Withdrawal|Time to treatment withdrawal was defined as the time from the first infusion of ofatumumab until the date of treatment withdrawal. The sponsor discontinued the intravenous route of administration development program for rheumatoid arthritis (RA), and this study was terminated early; hence, this primary endpoint was not evaluated.|From Baseline up to 144 weeks|Full Analysis Set (FAS) Population: all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment.||||||
1231217|NCT00655811|Secondary|The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application.|This secondary outcome is to see if subjects rated burning/pain differently between the topical capsaicin or placebo application. Participants will rate burning/pain intensity after topical capsaicin and placebo application. The burning/pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable burning/pain sensation). The subjects were also asked to indicate whether they experienced any non-burning/-painful sensation.|1 day||||units on a scale||Standard Deviation|Mean
1231218|NCT00655811|Secondary|Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds|A secondary endpoint is to see if topical capsaicin has an effect on warm and heat pain thresholds. Quantitative thermosensory testing was carried out using the Medoc TSA 2001 (Medoc Ltd). The probe baseline temperature was 32 °C and the contact area was 12 cm2. The probe warmed the skin surface at a linear rate of 0·4 °C per second, up to a cut-off of 50 °C. Thermal thresholds were measured in the following order: warmth sensation threshold was measured followed by heat pain detection threshold; each of them was determined four times by the ascending method of limits.|1 day||||Change in degrees Celsius||Standard Error|Mean
1231219|NCT00655811|Primary|Ethnic Differences in Burning Pain Induced by Topical Capsaicin|The primary endpoint is to test the burning pain effect of topical capsaicin by using an continuous visual analog scale (CoVAS) intensity scale as an outcome measure. Participants will rate burning pain intensity after topical capsaicin application. The burning or pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable pain sensation). The subjects were also asked to indicate whether they experienced any nonpainful sensation.|1 day||||units on a scale||Standard Error|Mean
1231220|NCT00655746|Primary|Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||ng∙h/mL||Full Range|Geometric Mean
1231221|NCT00655746|Primary|Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])|area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])for dasatinib|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||ng∙h/mL||Full Range|Geometric Mean
1231222|NCT00655746|Primary|Dasatinib PK Parameter: Plasma Half-Life (T-HALF)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=plasma half-life|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||hours||Standard Deviation|Mean
1231223|NCT00655746|Primary|Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Tmax=time of maximum observed plasma concentration|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||hours||Full Range|Median
1231224|NCT00655746|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7)||||Participants|||Number
1231225|NCT00655746|Primary|Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of dasatinib|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||ng/mL||Full Range|Geometric Mean
1231226|NCT00655733|Secondary|Safety||12 weeks|||||||
1231361|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 52|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52|52 weeks|For the 52-week analysis, it was planed to analyse for Linagliptin 5mg and 10mg. Then the patients with placebo and voglibose were excluded in this analysis. Full analysis set for 52-week treatment period with Last Observation Carried Forward|||Participants|||Number
1231228|NCT00655668|Secondary|Safety|Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)|Up to 24 months|Safety Population (received at least one dose of study drug)|||Participants|||Number
1231229|NCT00655668|Secondary|Progression-Free Survival|Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.|Up to 24 months|Intent-to-treat (ITT) Population|||Months||95% Confidence Interval|Median
1231230|NCT00655668|Secondary|Time-to-Progression|Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.|Up to 24 months|Due to early termination of study, data not analyzed. See outcome #4 for progression-free survival.||||||
1231231|NCT00655668|Secondary|Duration of Response|Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.|Up to 24 months|Intent-to-treat (ITT) Population|||Months||95% Confidence Interval|Median
1231232|NCT00655668|Primary|Participants Categorized by Best Response as Determined by Investigator|"Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail):~Complete Response(CR): Complete disappearance of all detectable disease~Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow~Partial Response(PR): >50% decrease in six largest nodes/nodal masses~Stable Disease(SD): Less than PR, but not progressive disease~Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites~Progressive Disease(PD): >=50% increase from low in PR/Non-Responders"|Up to 24 months|Intent-to-treat (ITT) Population|||Participants|||Number
1231233|NCT00655642|Primary|Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.|"Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words Least Severe on the left and Most Severe on the right. The possible values range from 0 to 100mm with 0 at the Least Severe extreme and 100 at the Most Severe extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes)."|Baseline and 30 minute assessments|Analysis was performed on all patients who received one of the four treatments and completed the 30-minute VAS assessment. The trial was anticipated to require 18 months to achieve full accrual of patients (n=600). Given that we were at 30% information fraction at 17 months, an unplanned interim analysis was done.|||millimeter||Inter-Quartile Range|Median
1231234|NCT00655629|Secondary|Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale|Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of participants|||Number
1231235|NCT00655629|Secondary|Satisfaction With Medication at Week 12 or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with medication at LOCF expressed as the least square mean difference"|up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.|||scores on a scale||Standard Deviation|Mean
1231236|NCT00655629|Secondary|Change From Baseline in Confidence for Completion at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Confidence for completion from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
1231237|NCT00655629|Secondary|Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with orgasm from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
1231238|NCT00655629|Secondary|Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Pleasure of sexual activity from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
1234099|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||micromole per liter [µmol/L]||Full Range|Median
1231239|NCT00655629|Secondary|Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Erectile function satisfaction from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
1231240|NCT00655629|Secondary|Change From Baseline in Ease With Erection at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Ease with Erection from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
1231241|NCT00655629|Secondary|Number of Sexual Attempts Till First Successful Attempt||up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||Sexual Attempts||Standard Deviation|Mean
1231242|NCT00655629|Secondary|Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of ejaculation successes||Standard Deviation|Mean
1231243|NCT00655629|Secondary|Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of satisfactory attempts||Standard Deviation|Mean
1231244|NCT00655629|Secondary|Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of satisfactory erections||Standard Deviation|Mean
1231245|NCT00655629|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of successful erections||Standard Deviation|Mean
1231246|NCT00655629|Secondary|"Percentage of Subjects Achieving Back to Normal Erectile Function"|Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of subjects|||Number
1231247|NCT00655629|Primary|Change From Baseline in Success of Erection Maintenance at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of successful maintenance||Standard Deviation|Mean
1231248|NCT00655629|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks|SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of successful penetrations||Standard Deviation|Mean
1231249|NCT00655629|Primary|Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)|The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.)|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
1231250|NCT00655564|Secondary|Safety of Alefacept Using CD4 Counts|Number of participants experiencing CD4 cell counts below 250/uL|52 weeks||||Participants|||Number
1231251|NCT00655564|Primary|Efficacy|Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52|52 weeks||||#Participants|||Number
1235166|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 12, ITT Population.||Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1231252|NCT00655551|Secondary|Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|0-4 hours post start of the infusion||||subjects|||Number
1231253|NCT00655551|Primary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)||||subjects|||Number
1231254|NCT00655551|Primary|Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|Treatment period (up to 7 days)||||subjects|||Number
1231255|NCT00655486|Primary|Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|2 years|All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis|||subjects|||Number
1231256|NCT00655486|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|2 years|All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis|||subjects|||Number
1231257|NCT00655356|Secondary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
1231258|NCT00655356|Secondary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
1231259|NCT00655356|Primary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) and 6 months after last treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
1231260|NCT00655356|Primary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) and 6 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
1231261|NCT00655083|Secondary|Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.|Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.|one week|Number of adverse events by dose and age stratum (18-24 weeks of age) are reported by system organ class and preferred term.|||Adverse Events|||Number
1231262|NCT00655083|Primary|Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.|Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.|24 hours|Urinary drug concentration was analysed by dose and age stratum of the infants (18-24 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces.|||ng||Standard Deviation|Mean
1231263|NCT00655083|Secondary|Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.|Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks.|one week|Number of adverse events by dose and age strata (6-<12 and 12- <18 weeks of age) are reported by system organ class and preferred term.|||Adverse Events|||Number
1231362|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 26|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.|||Participants|||Number
1231264|NCT00655083|Primary|Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.|Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.|24 hours|Urinary drug concentration was analysed by dose and age stratum of the infants (6-<12 and 12- <18 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces.|||ng||Standard Deviation|Mean
1231265|NCT00654992|Primary|Number of Participants Who Had AKI (Acute Kidney Injury)|number of participants who had 50% increase in serum creatinine levels from baseline|at any time within the first 5 days after surgery||||participants|||Number
1231266|NCT00654992|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)|estimated glomerular filtration rate (eGFR)as ml/min/1.73m2|during the first 5 days after surgery||||ml/min/1.73m2||Standard Deviation|Mean
1231267|NCT00654953|Primary|Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites|Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine.|70 days|Participants who completed the two-week residential stay and had 2 urine samples consecutively positive for cocaine were included in the analysis.|||Days to relapse (two consec coc+ urines)|Participants|Standard Deviation|Mean
1231268|NCT00654940|Secondary|Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment|Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined).|Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)|FAS; End of Treatment is treatment week 2 (Week 2 and Week 6) for Periods 1 and 2.|||scores on scale||Standard Error|Least Squares Mean
1231269|NCT00654940|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI at end of treatment: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.|Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)|FAS. Weeks 0 and 4 are baseline for Periods 1 and 2, respectively. Weeks 2 and 6 are End of Treatment for Periods 1 and 2, respectively.|||scores on scale||Standard Deviation|Mean
1231270|NCT00654940|Primary|Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale|Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.|Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)|Full Analysis Set: (FAS): all subjects randomized who received at least one dose of study drug, regardless of whether they had efficacy data. Baseline is Week 0 and Week 4 for Periods 1 and 2, respectively. Treatment Week 2 is End of Treatment (Week 2 and Week 6) for Periods 1 and 2, respectively.|||scores on scale||Standard Deviation|Mean
1231271|NCT00654927|Secondary|Expanded Disability Status Scale (EDSS)|"Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death)~*EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation"|Screening visit, visit 6 and every 24 months thereafter|ITT Population. No imputation for data missing|||units on a scale||Standard Deviation|Mean
1231272|NCT00654927|Secondary|Clinician Global Impression of Change (CGIC)|The CGIC was based on the Investigator’s overall impression of the patient’s neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse)|visit 1 and every clinic visit|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Median
1231273|NCT00654927|Secondary|Subject Global Impression (SGI)|The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 7 = delighted)|visit 1 and every clinic visit|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Mean
1231274|NCT00654927|Secondary|Timed 25 Foot Walk (T25FW)||Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit|ITT Population. No imputation for missing data|||feet/second||Standard Deviation|Mean
1231275|NCT00654927|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|over 7 years (2004-2011)|Safety Population. No imputation for missing data|||participants|||Number
1231285|NCT00654875|Primary|Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
1231276|NCT00654901|Primary|Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine|"Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable."|Days 0 up to 7 after any injection|Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population).|||Participants|||Number
1231277|NCT00654901|Primary|Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine|"Antibody persistence and immunogenicity response:~Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0."|Day 0 (pre-booster) and Day 30 (one month post-booster)|Antibody persistence and immunogenicity response were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per Protocol Population).|||Participants|||Number
1231278|NCT00654901|Primary|Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.|Day 0 (pre-booster) and Day 30 (one month post-booster)|Geometric mean titers were assessed in a subset of participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1231279|NCT00654875|Secondary|Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10)|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10).~Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg."|Week 10|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 10.|||Percentage of participants|||Number
1231280|NCT00654875|Secondary|Percentage of Participants Achieving Blood Pressure Control at Week 6|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6).~Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg."|Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 6.|||Percentage of participants|||Number
1231281|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
1231282|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
1231283|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
1231284|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
1231286|NCT00654836|Secondary|Overall Survival|Overall survival was measured from treatment initiation to 80 months|80 Months|All enrolled participants are included in this analysis|||Months||95% Confidence Interval|Median
1231287|NCT00654836|Secondary|Response Rate at End of Treatment|Response to treatment was recorded 30 months following treatment initiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions .|30 Months|Of the 32 enrolled participants, two participants did not return to the clinic at 30 months for final evaluation of their response to treatment.|||participants|||Number
1231288|NCT00654836|Primary|Progression-free Survival|Progression-free survival was measured from treatment initiation to 30 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|30 Months|All enrolled participants are included in this analysis|||Months||95% Confidence Interval|Median
1231289|NCT00654784|Secondary|Safety and Tolerability, Assessed by Adverse Events, Blood and Urine Laboratory Measures, ECG.||1 year|||||||
1231290|NCT00654784|Secondary|Skeletal Muscle Strength (Upper Limb, Right and Left): Hand Grip, Elbow Flexors and Elbow Extensors (Upper Limb Score) Timed Walking Test (10 Metres) (Ambulant Patients Only)||1 year|||||||
1231291|NCT00654784|Secondary|Respiratory Function: Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), Maximal Inspiratory Pressure (MIP) and Peak Flow (PF)||1 year|||||||
1231292|NCT00654784|Primary|The Relative Change in Peak Systolic Radial Strain of the Left Ventricle (LV) Inferolateral Wall From Baseline (at Screening) to Week 52, Assessed by Color Doppler Myocardial Imaging (CDMI).|"Assessing the peak systolic radial strain of the left ventricle inferolateral wall is used to characterize the cardiac involvement in the DMD patients.~Color Doppler Myocardial Imaging technique is used to quantify regional myocardial function.~The cardiac involvement in DMD is characterized by degeneration, atrophy and fibrosis of the myocardium, leading to dilated cardiomyopathy. The process begins in the posterolateral wall of the left ventricle, with septal involvement appearing at later stages."|baseline and Week 52|At Week 52, data from only 18 patients were available for the primary endpoint analysis due to missing data from 2 patients and the inability to acquire data from a 3rd patient. The efficacy comparison for the primary endpoint was conducted using the LOCF method in the ITT population. In addition, the analysis was repeated using the OC dataset.|||% change in peak systolic||Standard Deviation|Mean
1231293|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18|week 0 - week 18||||participants|||Number
1231294|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15|week 0 - week 15||||participants|||Number
1231295|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
1231296|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9|week 0 - week 9||||participants|||Number
1231297|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6|week 0 - week 6||||participants|||Number
1231298|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3|week 0 - week 3||||participants|||Number
1231299|NCT00654745|Secondary|Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
1231300|NCT00654745|Secondary|Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions|number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
1231301|NCT00654745|Secondary|Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
1231302|NCT00654745|Secondary|Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
1231303|NCT00654745|Secondary|Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
1231304|NCT00654745|Secondary|Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
1231305|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18|week 0 - week 18||||participants|||Number
1231306|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15|week 0 - week 15||||participants|||Number
1231307|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
1231308|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9|week 0 - week 9||||participants|||Number
1231309|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6|week 0 - week 6||||participants|||Number
1231310|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3|week 0 - week 3||||participants|||Number
1231311|NCT00654745|Secondary|Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
1231312|NCT00654745|Secondary|Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
1231313|NCT00654745|Secondary|Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12|number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
1231314|NCT00654745|Secondary|Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12|week 0 - week 12||||participants|||Number
1231315|NCT00654745|Secondary|Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
1231316|NCT00654745|Secondary|Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
1231317|NCT00654745|Secondary|Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks|change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.|week 0 - weeks 3, 6, 9, 12, 15, 18|Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.|||mm Hg||Standard Error|Mean
1231381|NCT00654355|Primary|Adherence|"adherence to topical therapy in children via MEMS cap in a real-life clinic population measured as the % of required applications completed"|Week 4||||percentage of required applicaitons||95% Confidence Interval|Median
1231321|NCT00654745|Primary|Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment|Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.|week 0 - week 12|ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12.|||mm Hg||Standard Error|Mean
1231322|NCT00654654|Primary|Independent Panel Global Improvement Assessment Compared to Baseline|An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.|Baseline (prior to treatment) compared to 6 months post last treatment|Number of patients for whom data were available|||participants|||Number
1231323|NCT00654654|Primary|Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment|Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.|Baseline (prior to first treatment) compared to 6 months post last treatment|Number of subjects for whom data were available from the assessment visit, 6 months after the final treatment|||participants|||Number
1231324|NCT00654641|Primary|Total Number of Patients Experiencing a Wound Complication|Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.|6 Weeks post-partum||||Participants|||Number
1231325|NCT00654628|Other Pre-specified|Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||mg/dL||Standard Deviation|Mean
1231326|NCT00654628|Secondary|Mean Percent Change of Triglycerides From Baseline at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Inter-Quartile Range|Median
1231327|NCT00654628|Secondary|Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
1231328|NCT00654628|Secondary|Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
1231329|NCT00654628|Secondary|Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
1231330|NCT00654628|Other Pre-specified|Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||mg/dL||Standard Deviation|Mean
1231331|NCT00654628|Secondary|Mean Percent Change of Triglycerides From Baseline at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Inter-Quartile Range|Median
1231332|NCT00654628|Secondary|Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
1231333|NCT00654628|Secondary|Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
1231334|NCT00654628|Secondary|Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
1231335|NCT00654628|Primary|The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.|Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.|Baseline and week 12|Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.|||Percentage of participants|||Number
1231352|NCT00654498|Primary|The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).|The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).|Baseline and 6 weeks of treatment|Full Analysis Set (FAS), All patients randomized, treated, having data for primary endpoint|||Score on a scale||Standard Error|Least Squares Mean
1231382|NCT00654329|Secondary|Length of Stay in PACU|Total time from PACU entry until discharge|up to 24 hours||||minutes||Standard Deviation|Mean
1231336|NCT00654628|Primary|The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.|Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.|Baseline and week 6|Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.|||Percentage of participants|||Number
1231337|NCT00654615|Secondary|Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)|The Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Each question is scored 1-5 with 1 meaning the least amount of severity of pain or difficulty and 5 meaning the maximum amount of pain or difficulty possible. At least 27 of the 30 items must be completed for a score to be calculate. All responses are summed and averaged producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. The overall DASH score ranged between 0-100. A higher score indicated greater disability.|two week post-surgery compared with six weeks post-surgery||||units on a scale||Standard Deviation|Mean
1231338|NCT00654615|Primary|Average Difference Between Michigan Hand Outcomes Questionnaire Scores|Developed at the University of Michigan Department of Plastic Surgery to evaluate outcomes and function in patients who sustain upper extremity injuries. This will be done one week post-surgery compared to six weeks post-surgery comparing the two groups. The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics, satisfaction. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. An overall MHQ score can be obtained by summing the scores for all six scales after reversing the pain scale (pain=100-pain score) and then dividing by six. The overall MHQ score ranged between 0-100. Higher scores indicate better hand performance.|two week post-surgery compared to six weeks post-surgery||||units on a scale||Standard Deviation|Mean
1231339|NCT00654511|Primary|Morphine Rescue|Total morphine administered in the Post Anesthesia Care Unit (PACU)|up to 24 hours||||micrograms/kilogram||Standard Deviation|Mean
1231340|NCT00654511|Primary|Time to First Morphine Dose|Total minutes from study medication administration to time of first morphine dose.|up to 24 hours||||minutes||Standard Deviation|Mean
1231341|NCT00654498|Secondary|The Change From Baseline in Visual Analogue Scales (VAS)|VAS is for assessment of RLS-associated pain. The patient was asked “How severe was your RLS associated pain in legs or arms during the past week?”. No pain:0; very worst pain:10|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
1231342|NCT00654498|Secondary|The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale|RLS-6 rating scales comprises 6 questions. The intensity of tiredness and sleepiness at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the intensity of tiredness and sleepiness at day.|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
1231343|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale|RLS-6 rating scales comprises 6 questions. The severity of RLS during the activities at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the activity at day.|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
1231344|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS during the test at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the rest at day.|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
1231345|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS during the night is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the night.|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
1231346|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS at time of falling sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS at time of falling sleep|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
1231347|NCT00654498|Secondary|the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales|RLS-6 rating scales comprises 6 questions Satisfaction of sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the satisfaction of sleep.|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
1231348|NCT00654498|Secondary|The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10|The ESS is a self-administered instrument to assess the patients likelihood of falling asleep in various activities of daily living; the maximum score is 24 indicating a very high level of daytime sleepiness and a high likelihood of falling asleep.|week 6 of treatment||||Proportion of Patients|||Number
1231349|NCT00654498|Secondary|The Proportion of Patient Global Impression(PGI) Responders|"PGI was a one-question scale with 7 degrees to assess patient's overall condition, ranging from very much better to very much worse. The responder are defined as patients with their assessment of much better or very much better."|6 weeks of treatment||||Proportion of participants|||Number
1231350|NCT00654498|Secondary|The Proportion of IRLS Responders|responders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population.|6 weeks of treatment||||Proportion of Patients|||Number
1231353|NCT00654420|Secondary|Phase II: Percentage of Participants With Complete Response (CR) or Partial Response (PR) After Dalotuzumab Plus Erlotinib Treatment (Objective Response Rate [ORR])|"ORR was defined as the percentage of participants in the Phase II analysis population having complete response (CR) or partial response (PR) during the course of the study.~RECIST criteria were used to quantify response rate. For evaluation of target lesions, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. For evaluation of non-target lesions, CR was defined as disappearance of all non-target lesions and normalization of tumor marker level.~Confirmation of response required a second assessment performed 4 weeks or more after the initial assessment. If the confirmation assessment contradicted the initial assessment, it was considered that a response had not been observed. If the confirmation assessment of a participant was not available, that participant was not considered as a responder in the response rate analyses."|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|All randomized participants in Phase II who received ≥1 dose of study treatment, had a baseline radiological (CT or MRI) disease assessment, and had ≥1 post-baseline radiological (CT or MRI) disease assessment subsequent to ≥1 dose of study treatment for reason other than discontinuation for AE. Phase I participants were not assessed for ORR.|||percentage of participants||95% Confidence Interval|Number
1231354|NCT00654420|Secondary|Phase II: Median Overall Survival (OS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment|OS was defined as the time from randomization to death in months due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The nonparametric Kaplan-Meier method was used to estimate the survival time distribution and the median survival of each treatment group.|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|Intent to Treat (IIT) Population; all randomized participants in Phase II included regardless of compliance to planned treatment. Phase I participants were not assessed for OS.|||months||95% Confidence Interval|Median
1231355|NCT00654420|Primary|Phase II: Median Progression Free Survival (PFS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment|PFS was defined as the time from randomization until either the emergence of radiographic evidence of disease progression or death due to any cause, whichever occurs first. Disease progression was classified as a radiographic assessment of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) using computed tomography (CT) or magnetic resonance imaging (MRI). As pre-specified by the protocol, final analysis of PFS was to take place after approximately 49 PFS events or deaths had occurred in the Phase II part of the trial. A non-parametric Kaplan-Meier method was used to estimate the median PFS time for each treatment group. Participants who discontinued from the study for reasons other than progression of disease were treated as right-censored observations at the time of the last response evaluation. Participants who withdrew from the study due to PD were considered to have a disease progression between the last visit and the time of withdrawal.|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|All randomized participants in Phase II who received ≥1 dose of study treatment, had a baseline radiological (CT or MRI) disease assessment, and had ≥1 post-baseline radiological (CT or MRI) disease assessment subsequent to ≥1 dose of study treatment for reason other than discontinuation for AE. Phase I participants were not assessed for PFS.|||months||95% Confidence Interval|Median
1231356|NCT00654420|Primary|Phase I: Number of Participants Experiencing at Least One Dose-Limiting Toxicity (DLT) Adverse Event (AE) During the First Four Weeks of Dalotuzumab Plus Erlotinib Treatment|"A DLT was an AE related (definitely, probably, or possibly) to study therapy and occurring within first 4 weeks of therapy.~Hematologic DLTs included Grade (Gr)4 neutropenia lasting for ≥7 days, Gr 3/Gr 4 neutropenia with fever >38.5 °C and/or infection requiring antibiotic or anti-fungal treatment, and Gr 4 thrombocytopenia (25.0 x 10^9/L).~Non-hematologic DLT defined as any ≥Gr 3 nonhematologic toxicity, except Gr 3 reversible rash; Gr 3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia occurring in setting of inadequate compliance with supportive care; alopecia; anorexia; asthenia; inadequately-treated hypersensitivity reactions; Gr 3 elevated transaminases (≤1 week duration); or infusion reactions to dalotuzumab.~Any drug-related AEs that led to dose modification of dalotuzumab/erlotinib or any unresolved drug-related toxicity that caused a ≥3 week delay of next scheduled dose of study drug, regardless of Common Terminology Criteria grade, were DLTs."|Up to 4 weeks after initiation of treatment|Participants in the Phase I part of the study who received at least one dose of dalotuzumab in combination with erlotinib during the first 4 weeks of treatment and were evaluable for DLT assessment. Participants in the Phase II part of the study were not evaluated for DLTs.|||participants|||Number
1231357|NCT00654381|Primary|Examination of Long-term Safety of Linagliptin (52-week Treatment)|The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks|52 weeks|The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period|||participants|||Number
1231358|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|52 weeks|The patients who had at least one available baseline FPG measurement under the treatment with linagliptin|||mg/dL||Standard Error|Least Squares Mean
1231359|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward|||mg/dL||Standard Error|Least Squares Mean
1231360|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.|||mg/dL||Standard Error|Least Squares Mean
1231363|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 12|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.|||Participants|||Number
1231364|NCT00654381|Primary|Change From Baseline in HbA1c at Week 26|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.|||Percent||Standard Error|Least Squares Mean
1231365|NCT00654381|Primary|Change From Baseline in HbA1c at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.|||Percent||Standard Error|Least Squares Mean
1231366|NCT00654368|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined by regulatory authorities as one that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.|25 months|Safety Analysis Set|||participants|||Number
1231367|NCT00654368|Secondary|Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)|The Treatment Satisfaction Questionnaire for Medication is a 14-item self-administered questionnaire which measures patients’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. Optional responses are: Extremely Dissatisfied (1), Very Dissatisfied (2), Dissatisfied (3), Somewhat Satisfied (4), Satisfied (5), Very Satisfied (6), and Extremely Satisfied (7). For each dimension, responses are added and transformed to a scale from 0 – 100, where higher scores indicate greater satisfaction. Change from Month 6 is reported for each dimension; a positive change score indicates improvement. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; LOCF. n indicates the number of participants with available data at each time point.|||scores on a scale||Standard Deviation|Mean
1231368|NCT00654368|Secondary|Change From Month 6 in Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. For each measure change from Month 6 is reported; a negative change score indicates improvement. End of study is month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; Work time missed and work impairment scores are only calculated for participants who were employed at the time. LOCF imputation was used.|||scores on a scale||Standard Deviation|Mean
1231369|NCT00654368|Secondary|Change From Month 6 in Short Form 36 Health Survey (SF-36)|"The SF-36 assesses the general quality of life (QOL) of participants by evaluating the domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The questionnaire consists of 36 questions that are completed by the participant.~The SF-36 is split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.~End of study is month 24 or early termination."|Month 6, 12, 18 and 24|Intent to treat analysis set with available SF-36 data at month 6; LOCF|||scores on a scale||Standard Deviation|Mean
1231370|NCT00654368|Secondary|Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)|The HAQ pain visual analog scale (VAS) is a measure of pain on a continuous 100 point scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 (severe pain). End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; LOCF|||scores on a scale||Standard Deviation|Mean
1231371|NCT00654368|Secondary|Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)|The HAQ disability index is a patient-reported questionnaire specific for rheumatoid arthritis that addresses health-related quality of life. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (score=0) to 'unable to do' (score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change score indicates an improvement. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set; LOCF|||scores on a scale||Standard Deviation|Mean
1231383|NCT00654329|Primary|Incidence of Pain|Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)|up to 24 hours||||participants|||Number
1231384|NCT00654186|Secondary|Time to Disesase Progression as Measured by Radiographic Progression|Progressive disease (PD) was determined, as outlined in the protocol, by using Recist 1.0. PD is defined as greater than or equal to a 20% increase in the sum of all measureable lesions or the apprearance of two new bone lesions or the appearnce of one new soft tissue lesion.|24 months||||months||Full Range|Median
1231385|NCT00654186|Secondary|Time to PSA Progression|As defined in the protocol PSA progression was an increase of at least 25%|24 months for acrual||||months||Full Range|Median
1231372|NCT00654368|Secondary|Change From Baseline in Joint Space Narrowing|"X-rays of hands and feet were read centrally and in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (15 joints) and each foot (6 joints) on a 5-point scale scored as follows:~0 = normal; 1 = focal or doubtful; 2 = generalised, less than 50% of the original joint space; 3 = generalised, more than 50% of the original joint space or subluxation; 4 = bony ankylosis or complete luxation. The scores were summed to calculate the total JSN score ranging from 0 to 168 (worst). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.~End of study is Month 24 or early termination."|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.|||scores on a scale||Standard Deviation|Mean
1231373|NCT00654368|Secondary|Change From Baseline in Joint Erosion Score|X-rays of hands and feet were read centrally and in a blinded manner. Sixteen joints on each hand/wrist and 6 joints on each foot were scored for erosions on a scale of 0 to 5 (or for the feet from 0 to 10, with each side of the joint independently scored from 0 to 5) according to the following: One point is scored if erosions are discrete, rising to 2, 3, 4, or 5 depending on the amount of surface area affected (complete collapse of the bone is scored as 5). Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 280 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion. End of study is Month 24 or early termination.|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a Baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.|||scores on a scale||Standard Deviation|Mean
1231374|NCT00654368|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|The modified Total Sharp Score (mTSS) is a measure of change in joint health. X-rays of hands and feet were scored in a blinded manner by an independent reader. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (bony ankylosis or complete luxation). Erosion scores and narrowing scores were added to obtain the total mTSS score, ranging from 0 (normal) to 448 (maximal disease). An increase in mTSS from Baseline (represented by a positive change from Baseline score) indicates disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease (negative change from Baseline score) represents improvement. End of study is Month 24 or early termination.|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.|||scores on a scale||Standard Deviation|Mean
1231375|NCT00654368|Secondary|Drug Persistence|Drug persistence is defined as the percentage of participants receiving etanercept at 6, 12, 18, and 24 months.|Month 6, 12, 18 and 24|Intent to Treat Analysis Set|||percentage of participants|||Number
1231376|NCT00654368|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean changes in DAS28 scores from Baseline were multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity. End of study is Month 24 or early termination.|Baseline and Month 6, 12, 18 and 24|Intent to treat; LOCF. The number of participants with available data at Month 6 was 95 and 105 in each treatment group respectively.|||scores on a scale||Standard Deviation|Mean
1231377|NCT00654368|Secondary|Disease Activity Score (DAS) 28 Response|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. Remission is defined by a DAS28 score less than 2.6. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Moderate is defined as a DAS28 higher than 3.2 but lower than or equal to 5.1. DAS28 above 5.1 indicates high disease activity. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat population (all randomized participants); Last observation carried forward (LOCF) imputation was used. At Month 6 data were available for 95 and 105 participants in each treatment group respectively.|||Percentage of participants||95% Confidence Interval|Number
1231378|NCT00654368|Primary|Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.|Month 6 (randomization) and Month 12|The per protocol population defined as all randomized participants with DAS28 measurements both at the 6- and 12-month visit.|||scores on a scale||Standard Error|Least Squares Mean
1231379|NCT00654355|Secondary|EASI|Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.|Week 4||||units on a scale||Standard Deviation|Mean
1231380|NCT00654355|Secondary|The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.|Investigator Global Assessment: Investigator’s Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from ‘0’ = clear or “No inflammatory signs of AD” to ‘4’ = Very Severe Disease with “severe erythema and severe papulation/infiltration with oozing/crusting.”|Week 4||||% change in IGA||95% Confidence Interval|Median
1231386|NCT00654186|Primary|Number of Participants With Overall Clinical Benefit (OCB), Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants|"The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as > or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined < a 30% decrease in the sum of the longest diameter of measureable lesions and < a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions.~Prostate-Specific Antigen (PSA) was also evaluated. A PSA CR was a PSA < or equal to 4 ng/dl. A PSA PR was a PSA that decreased by > or equal to 50%. Stable PSA was defined as a PSA that increased >25% and decreased < 50%."|24 months for acrual|evaluable patients|||percentage of patients|||Number
1231387|NCT00654147|Primary|Time to Virologic Failure|time to virologic failure at week 24 (up to 48 weeks)|week 24 (up to 48 weeks)||||weeks||Standard Deviation|Median
1231388|NCT00654147|Secondary|Study Medication Tolerability|study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment|date started study treatment to first week documented change study treatment up to week 48||||participants|||Number
1231389|NCT00654147|Secondary|Change From Baseline CD4+ and CD8+ Cell Counts|mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms|Baseline, Weeks 16 and 24|Change from baseline compared between arms using repeated measures analysis of covariance. Linear mixed models used to accomplish these analyses.|||cells/mm3||Standard Error|Mean
1231390|NCT00654147|Secondary|Weeks to HIV-1 RNA <200 Copies/ml|time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml|from date of treatment start to first week documented viral suppression||||week to viral supresssion||95% Confidence Interval|Median
1231391|NCT00654147|Secondary|Study Medication Toxicity-related Discontinuation .|grade 3 and grade 4 symptoms and laboratory study treatment limiting toxicity|48 weeks||||participants|||Number
1231392|NCT00654147|Primary|Time to Confirmed Virologic Failure|time to confirmed viologic failure at 24 weeks (up to 48 weeks)|weeks|descriptive|||weeks||95% Confidence Interval|Median
1231393|NCT00654095|Primary|Number of Participants With Adverse Events and Adverse Reactions|"An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.~That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.~Any adverse event that was considered treatment-related was considered an adverse reaction."|Throughout 1 year of study||||Participants|||Number
1231394|NCT00654069|Primary|SPID48|"Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0).~SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5*.5 + PID1*.5 + PID2*1 + PID3*1 + PID4*1 + PID6*2 +PID12*6 + PID18*6 +PID24*6 + PID30*6 + PID36*6 + PID42*6 + PID48*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings)."|48 hours||||score on a scale||Standard Deviation|Mean
1231395|NCT00654030|Primary|Number of Participants Responding to the Vaccine|The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.|16 weeks after vaccination||||Participants|||Count of Participants
1231396|NCT00654004|Secondary|The Difference in Plasma Insulin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting insulin levels in uU/ml were measured in both groups. The differences between groups were compared with a t-test|Fasting insulin levels uUnits/ml|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. Samples were missing on one subject so 11 subjects were compared to 11 controls.|||uU/ml||Standard Deviation|Mean
1231397|NCT00654004|Secondary|The Difference in Plasma Leptin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting leptin in ng/kg fat mass were measured in both groups (subjects with a long-chain fatty acid oxidation disorder; controls). The differences between groups were compared with a t-test|Fasting leptin levels ng per kg of fat mass|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.|||ng/kg||Standard Deviation|Mean
1231398|NCT00654004|Primary|An Outcome of This Study is the Difference in Glucose Tolerance Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.|"Glucose tolerance was estimated by the Matsuda Index using glucose and insulin values from a standard oral glucose tolerance test. The Matsuda Index is calculated by the following formula: 10,000/ sq root of (fasting glucose mg/dl X fasting insulin in units/ml) X (mean glucose (mg/dl) X mean insulin (units/ml) and correlates with insulin sensitivity measured by the gold standard method of a hyperinsulinemic euglycemic clamp. Values of 2.5 or greater are considered insulin sensitive. Values of 2.4 or less are considered insulin resistance.~The Matsuda Index of Insulin Sensitivity was measured in subjects with a long-chain fatty acid oxidation disorder (n=12). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed an oral glucose tolerance test. The difference in Mastuda Index between subjects and age matched controls was compared by t-test."|Subjects will be compared to controls at one point in time.|Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.|||units on a scale||Standard Deviation|Mean
1235167|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 6, ITT Population.||Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1231399|NCT00654004|Secondary|The Difference in Plasma Adiponectin Levels Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting total adiponectin levels in ug/ml were measured in both groups (subjects with a long-chain fatty acid oxidation disorder). The differences between groups were compared with a t-test|Fasting total adiponectin (ug/ml)|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.|||ug/ml||Standard Deviation|Mean
1231400|NCT00654004|Primary|An Outcome of This Study is the Difference in Percent Body Fat (%BF) Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.|Body composition by DEXA was measured in subjects with a long-chain fatty acid oxidation disorder (n=13). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed body composition measures. The difference in body composition between subjects and age matched controls was compared by t-test.|Subjects will be compared to controls at one point in time.|Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.|||percentage of body fat||Standard Deviation|Mean
1231401|NCT00653939|Secondary|Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)||Day 1 (pretreatment) per 21-day Cycle (6 Cycles)|Safety Population|||participants|||Number
1231402|NCT00653939|Secondary|Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)||Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)|Safety Population|||participants|||Number
1231403|NCT00653939|Secondary|Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)||Days 1 (pretreatment) per 21-day Cycle (6 Cycles)|Safety Population|||participants|||Number
1231404|NCT00653939|Primary|Progression Free Survival (PFS) in the Intent-to-Treat Population|Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.|Six 21-day cycles|Intent-to-Treat|||months||95% Confidence Interval|Median
1231405|NCT00653939|Secondary|Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population||Until death or lost to follow-up, up to 12 months since randomization|Intent-to-Treat|||Months||95% Confidence Interval|Median
1231406|NCT00653939|Secondary|Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population|Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.|Six 21-day cycles|Intent-to-Treat|||participants|||Number
1231407|NCT00653861|Secondary|Nasolabial Fold (NLF) Severity|Determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.|2 weeks|ITT|||Units on a scale||Standard Deviation|Mean
1231408|NCT00653861|Secondary|Comparative Pain|A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.|1 day|ITT|||Percent of Participants|||Number
1231409|NCT00653861|Primary|Procedural Pain Score|Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.|1 day|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1231410|NCT00653523|Primary|Number of Participants With Adverse Events and Adverse Reactions|"An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.~That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.~Any adverse event that was treatment-related was considered an adverse reaction."|Throughout 1 year of study||||Participants|||Number
1231411|NCT00653328|Secondary|Number of Patients With Worst Grade Toxicities|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria|Weekly for 2 weeks, then monthly for 5 months||||participants|||Number
1231412|NCT00653328|Secondary|Overall Survival||Date on study to date of death from any cause|All patients who received treatment. Two patients alive at last follow-up.|||Months||Full Range|Median
1231413|NCT00653328|Secondary|Number of Patients With Objective Response|"Patient response to treatment:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of >= 1 new lesions, and/or 2x CA-125 levels to >=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|At month 2 and monthly thereafter to cessation of treatment|Patients who were available for measurement of tumor response.One patient withdrew after beginning treatment and was not available for measurement.|||participants|||Number
1231414|NCT00653328|Primary|Median Time to Tumor Progression|Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level >=2x baseline and >=70 IU/ml, confirmed by a second determination at least 28 days after the first determination|Date on study to the date of measured progressive disease, every 2 cycles (2 months)|Patients available for measurement of tumor response. One patient withdrew after beginning treatment.|||Months||Full Range|Median
1231417|NCT00653263|Primary|Methamphetamine Selective Severity Assessment (MSSA)|Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms.|Baseline through week 4||||"units on a scale"||Standard Deviation|Mean
1231418|NCT00653224|Secondary|Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population|||participants|||Number
1231419|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.|Baseline and week 2|Number of participants from the ITT population with available ESS score at Week 2 and at Baseline|||points on a scale||Standard Deviation|Mean
1231420|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.|Baseline and week 1|Number of participants from the ITT population with available ESS score at Week 1 and at Baseline|||points on a scale||Standard Deviation|Mean
1231421|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available ESS score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231422|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
1231423|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
1231424|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
1231425|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
1231426|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
1231448|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular tearing/watering score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231471|NCT00653224|Secondary|Sneezing Score Over the First Week|The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available sneezing score over Week 1|||points on a scale||Standard Deviation|Mean
1231427|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
1231428|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
1231429|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
1231430|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
1231431|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
1231432|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
1231433|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
1231434|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
1231435|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
1231449|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the Second Week|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular tearing/watering score over Week 2|||points on a scale||Standard Deviation|Mean
1235168|NCT00619957|Secondary|Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.||Baseline to Month 3|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1231436|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
1231437|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
1231438|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
1231439|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
1231440|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
1231441|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
1231442|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
1231443|NCT00653224|Secondary|Global Physician’s Rating of Efficacy at Endpoint During the Two Week Treatment Period|"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from Marked worsening to Marked improvement."|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population|||participants|||Number
1231444|NCT00653224|Secondary|Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period|"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from Marked worsening to Marked improvement."|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population|||participants|||Number
1231445|NCT00653224|Secondary|Ocular Redness Score Over the Total Treatment Period (14 Days)|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular redness score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231446|NCT00653224|Secondary|Ocular Redness Score Over the Second Week|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular redness score over Week 2|||points on a scale||Standard Deviation|Mean
1231447|NCT00653224|Secondary|Ocular Redness Score Over the First Week|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular redness score over Week 1|||points on a scale||Standard Deviation|Mean
1231450|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the First Week|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular tearing/watering score over Week 1|||points on a scale||Standard Deviation|Mean
1231451|NCT00653224|Secondary|Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular itching/burning score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231452|NCT00653224|Secondary|Ocular Itching/Burning Score Over the Second Week|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular itching/burning score over Week 2|||points on a scale||Standard Deviation|Mean
1231453|NCT00653224|Secondary|Ocular Itching/Burning Score Over the First Week|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular itching/burning score over Week 1|||points on a scale||Standard Deviation|Mean
1231454|NCT00653224|Secondary|Ocular Pruritus Score Over the Total Treatment Period (14 Days)|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular pruritus score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231455|NCT00653224|Secondary|Ocular Pruritus Score Over the Second Week|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular pruritus score over Week 2|||points on a scale||Standard Deviation|Mean
1231456|NCT00653224|Secondary|Ocular Pruritus Score Over the First Week|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular pruritus score over Week 1|||points on a scale||Standard Deviation|Mean
1231457|NCT00653224|Secondary|Post-nasal Drip Score Over the Total Treatment Period (14 Days)|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available post-nasal drip score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231458|NCT00653224|Secondary|Post-nasal Drip Score Over the Second Week|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available post-nasal drip score over Week 2|||points on a scale||Standard Deviation|Mean
1231459|NCT00653224|Secondary|Post-nasal Drip Score Over the First Week|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available post-nasal drip score over Week 1|||points on a scale||Standard Deviation|Mean
1231460|NCT00653224|Secondary|Nasal Pruritus Score Over the Total Treatment Period (14 Days)|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available nasal pruritus score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231461|NCT00653224|Secondary|Nasal Pruritus Score Over the Second Week|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available nasal pruritus score over Week 2|||points on a scale||Standard Deviation|Mean
1231462|NCT00653224|Secondary|Nasal Pruritus Score Over the First Week|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available nasal pruritus score over Week 1|||points on a scale||Standard Deviation|Mean
1231463|NCT00653224|Secondary|Nasal Congestion Score Over the Total Treatment Period (14 Days)|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available nasal congestion score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231464|NCT00653224|Secondary|Nasal Congestion Score Over the Second Week|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available nasal congestion score over Week 2|||points on a scale||Standard Deviation|Mean
1231465|NCT00653224|Secondary|Nasal Congestion Score Over the First Week|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available nasal congestion score over Week 1|||points on a scale||Standard Deviation|Mean
1231466|NCT00653224|Secondary|Rhinorrhea Score Over the Total Treatment Period (14 Days)|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available rhinorrhea score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231467|NCT00653224|Secondary|Rhinorrhea Score Over the Second Week|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available rhinorrhea score over Week 2|||points on a scale||Standard Deviation|Mean
1231468|NCT00653224|Secondary|Rhinorrhea Score Over the First Week|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available rhinorrhea score over Week 1|||points on a scale||Standard Deviation|Mean
1231469|NCT00653224|Secondary|Sneezing Score Over the Total Treatment Period (14 Days)|The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available sneezing score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231472|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available TOSS over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231473|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the Second Week|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available TOSS over Week 2|||points on a scale||Standard Deviation|Mean
1231474|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the First Week|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available TOSS over Week 1|||points on a scale||Standard Deviation|Mean
1231475|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available TNSS over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231476|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the Second Week|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available TNSS over Week 2|||points on a scale||Standard Deviation|Mean
1231477|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the First Week|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available TNSS over Week 1|||points on a scale||Standard Deviation|Mean
1231478|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the total treatment period of 14 days is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available T4SS over the Total Treatment period|||points on a scale||Standard Deviation|Mean
1231479|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the Second Week|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available T4SS over Week 2|||points on a scale||Standard Deviation|Mean
1231480|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the First Week|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available T4SS over Week 1|||points on a scale||Standard Deviation|Mean
1231481|NCT00653224|Secondary|Total 5 Symptoms Score (T5SS) Over the Second Week|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available T5SS over Week 2|||points on a scale||Standard Deviation|Mean
1231482|NCT00653224|Secondary|Total 5 Symptoms Score (T5SS) Over the First Week|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided.|Over week 1|Number of participants from the ITT population with available T5SS over Week 1|||points on a scale||Standard Deviation|Mean
1231483|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ emotional score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
1231484|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ emotional score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
1231485|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ emotional score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231486|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
1231487|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
1231488|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ eye symptoms score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231489|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
1231490|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
1231491|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ nasal symptoms score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231492|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ practical problems score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
1231493|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ practical problems score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
1231494|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ practical problems score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231495|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
1231496|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
1231508|NCT00653159|Secondary|Device Satisfaction Rates|"Satisfaction rate is the proportion of subjects who report being happy or very happy with their assigned intrauterine contraceptive method on the date of their 6 month study visit."|6 months|Only subjects who were not lost to follow-up at 6 months were included in this analysis.|||percentage of subjects completing study|||Number
1231497|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231498|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
1231499|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
1231500|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231501|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
1231502|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
1231503|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231504|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.|Baseline and week 2|Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
1231505|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.|Baseline and week 1|Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
1231506|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1231507|NCT00653224|Primary|Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15.|Over the total treatment period (14 days)|Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period|||points on a scale||Standard Deviation|Mean
1231695|NCT00651625|Primary|Pain Using VAS (Visual Analogue Pain Scale)|0-10 cm VAS pain scale at 2 weeks compared to 0-10 cm VAS pain scale at 0 weeks where 0= no pain, and 10 = the worst pain imaginable. The difference (2 week VAS-0 week VAS) is the primary outcome measure.|2 weeks||||cm||Standard Deviation|Mean
1231509|NCT00653159|Secondary|Expulsion Rates|Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.|6 months|All study participants were included in the analysis.|||percentage of randomized subjects|||Number
1231510|NCT00653159|Secondary|Pregnancy Rates|Proportion of subjects who became pregnant within 6 months of IUD insertion|6 months|All study participants were included in the analysis.|||percentage of randomized subjects|||Number
1231511|NCT00653159|Secondary|Heavy Bleeding Rates|Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.|6 months|All study participants were included in the analysis.|||percentage of randomized subjects|||Number
1231512|NCT00653159|Primary|Retention Rate|Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)|6 months|All study participants were included in the analysis.|||percentage of randomized subjects|||Number
1231513|NCT00653133|Primary|Complications of Peripheral Nerve Block|Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic|Preoperative through 3 days post operative|Intent to treat (ITT)|||participants|||Number
1231514|NCT00653068|Secondary|Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy|Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy.|During protocol therapy up to 1 year after enrollment.|68 eligible patients were evaluable|||Participants|||Count of Participants
1231515|NCT00653068|Primary|Toxic Death|The number of patients who experience death that is considered to be primarily attributable to complications of treatment.|During and after completion of study treatment up to 1 year after enrollment.|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.|||Participants|||Count of Participants
1231516|NCT00653068|Primary|Overall Survival (OS)|Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored.|Up to 4 years after study enrollment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.|||Estimated Probability||95% Confidence Interval|Number
1231517|NCT00653068|Primary|Event-free Survival|Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.|Up to 4 years after study enrollment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.|||Estimated probability||95% Confidence Interval|Number
1231518|NCT00652951|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within the 31-day (Days 0-30) after booster vaccination|The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.|||Participants|||Count of Participants
1231519|NCT00652951|Secondary|Number of Subjects With Solicited General Symptoms - Booster Vaccination.|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.|During the 4-day (Days 0-3) post-vaccination period following booster dose|The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.|||Participants|||Count of Participants
1231520|NCT00652951|Secondary|Number of Subjects With Solicited Local Symptoms -Booster Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters from injection site.|During the 4-day (Days 0-3) post-vaccination period following booster dose|The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.|||Participants|||Count of Participants
1231521|NCT00652951|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Throughout the entire study period (up to Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
1231522|NCT00652951|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within the 31-day (Days 0-30) post-primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
1231541|NCT00652951|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.|Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.|Prior to (Month 9) and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1231523|NCT00652951|Secondary|Number of Subjects With Solicited General Symptoms - Primary Vaccination|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
1231524|NCT00652951|Secondary|Number of Subjects With Solicited Local Symptoms - Primary Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond (>) 30 millimeters from injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
1231525|NCT00652951|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.|Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).|Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
1231526|NCT00652951|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.|Acquisition of new H. influenzae* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.|Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
1231527|NCT00652951|Secondary|Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.|Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).|One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
1231528|NCT00652951|Secondary|Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.|Positive cultures of H. influenzae* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.|One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
1231529|NCT00652951|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1231530|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1231531|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.|Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1231696|NCT00651482|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) per RECIST criteria|24 months||||months||Full Range|Median
1231532|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.|Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
1231533|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1231534|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.|Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1231535|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.|Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
1231536|NCT00652951|Secondary|Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.|A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations < 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL).|One month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
1231537|NCT00652951|Secondary|Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.|Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.|Prior (Month 9) to and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1231538|NCT00652951|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL.|Prior (Month 9) to and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1231539|NCT00652951|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.|Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.|Prior (Month 9) to and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1231540|NCT00652951|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination|Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.|Prior to (Month 9) and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1231697|NCT00651482|Secondary|Treatment Discontinuation Due to Disease Progression|Number of subjects whose treatment was discontinued due to disease progression|24 months||||participants|||Number
1231542|NCT00652951|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|Prior (Month 9) to and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1231543|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|Prior to (Month 9) and one month after the administration of the booster dose (Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1231544|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination|Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.|Prior (Month 9) to and one month after the administration of the booster dose (Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1231545|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.|Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|Prior (Month 9) to and one month after the administration of the booster dose(Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
1231546|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|Prior (Month 9) to and one month after the administration of the booster dose(Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1231547|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination|Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.|Prior (Month 9) to and one month after the administration of the booster dose (Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1231548|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination|Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|Prior to (Month 9) and one month after the administration of the booster dose (Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
1231549|NCT00652951|Secondary|Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.|Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Titers||95% Confidence Interval|Geometric Mean
1231550|NCT00652951|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||mIU/mL||95% Confidence Interval|Geometric Mean
1231698|NCT00651482|Secondary|Treatment Discontinuation Due to Toxicity|Number of subjects whose treatment was discontinued due to toxicity|24 months||||participants|||Number
1231699|NCT00651482|Secondary|Total Number of Drug-related SAEs||24 months||||events|||Number
1231700|NCT00651482|Secondary|Number of Subjects With Drug-related SAEs||24 months||||participants|||Number
1231551|NCT00652951|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination|Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1231552|NCT00652951|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination|Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||µg/mL||95% Confidence Interval|Geometric Mean
1231553|NCT00652951|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination|Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||IU/mL||95% Confidence Interval|Geometric Mean
1231554|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Titers||95% Confidence Interval|Geometric Mean
1231555|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination|Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||µg/mL||95% Confidence Interval|Geometric Mean
1231556|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.|Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Participants|||Count of Participants
1231557|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Titers||95% Confidence Interval|Geometric Mean
1231558|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination|Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Participants|||Count of Participants
1231559|NCT00652951|Primary|Antibody Concentration Against Protein D (PD) - Primary Vaccination|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1231571|NCT00652938|Secondary|Anti-HBs Antibody Titers|"Anti-HBs antibody titers are given as GMTs in mIU/mL.~Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1231701|NCT00651482|Secondary|Overall Survival (OS)||44 months||||months||Full Range|Median
1231560|NCT00652951|Primary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination|Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.|At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||μg/mL||95% Confidence Interval|Geometric Mean
1231561|NCT00652938|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).|Throughout the safety follow-up (month 7 up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231562|NCT00652938|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).|Throughout the active phase of the study (up to Month 7)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231563|NCT00652938|Secondary|Number of Subjects Reporting Any and Causally Related to Vaccination SAEs|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~* Grade 3 SAEs were not assessed."|Throughout the safety follow-up (month 7 up to Month 12).|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231564|NCT00652938|Secondary|Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~Related SAEs were SAEs assessed by the investigators as related to the vaccination.~* Grade 3 SAEs were not assessed."|Throughout the active phase of the study (up to Month 7).|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231565|NCT00652938|Secondary|Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination."|During the 30-day period (Days 0 - 29) following any vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231566|NCT00652938|Secondary|Number of Subjects Reporting Related Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination."|During the 7-day period (Days 0 - 6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231567|NCT00652938|Secondary|Number of Subjects Reporting Grade 3 Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity.~Grade 3 temperature was temperature > 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas."|During the 7-day (Days 0-6) period following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231568|NCT00652938|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination."|During the 7-day (Days 0-6) period following vaccination.|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231569|NCT00652938|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms include injection site pain, redness and swelling.~Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was > 50 mm. Grade 3 swelling is swelling that was > 50 mm."|During the 7-day period (Days 0-6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231570|NCT00652938|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|"Solicited local symptoms included injection site pain, redness and swelling.~Any solicited local symptom is occurence of a symptom regardless of its intensity."|During the 7-day period (Days 0 - 6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231702|NCT00651482|Secondary|Time-to-Treatment Failure (TTF)||24 months||||months||Full Range|Median
1231703|NCT00651482|Secondary|Objective Response (OR) Duration||24 months||||weeks||Full Range|Median
1231704|NCT00651482|Secondary|Objective Response (OR)|Number of subjects with objective response (OR)|24 months||||participants|||Number
1231572|NCT00652938|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination.~Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1231573|NCT00652938|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.~Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1231574|NCT00652938|Secondary|Anti-HPV-16/18 Antibody Titres|"Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).~Only groups which had received the HPV vaccine were included in the analysis.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1231575|NCT00652938|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HPV vaccine were included in the analysis.~Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1231576|NCT00652938|Secondary|Anti-HBs Antibody Titres|"Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL.~Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1231577|NCT00652938|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.~Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1231578|NCT00652938|Primary|Anti-HPV-16/18 Antibody Titres|"Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).~Only groups which had received the HPV vaccine were included in the analysis.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1231579|NCT00652938|Primary|Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HPV vaccine were included in the analysis.~Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1231580|NCT00652938|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination.~Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1231581|NCT00652899|Secondary|Median Overall Survival Number of Days Patients Alive After Treatment|Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.|From first date on-study (treatment) to date of death||||Days||95% Confidence Interval|Median
1231582|NCT00652899|Secondary|Median Number of Days to Progression|Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) > or = 20% increase in sum of all target or any new lesions.|From date of first treatment to disease progression||||Days||95% Confidence Interval|Median
1231705|NCT00651313|Secondary|Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing||7 hours following fourth dose in 2 consecutive menstrual cycles|||||||
1231706|NCT00651313|Primary|Treatment-emgergent Adverse Events||approximately two months, based on onset of menses|||||||
1231583|NCT00652899|Secondary|Number of Patients Per Disease Response|Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- < or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of < or = 1 new lesion.|1 Month After Natural Killer Cell Infusion (Day 30)|Includes 12 patients that completed treatment per protocol criteria.|||Patients|||Number
1231584|NCT00652899|Primary|Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product|Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion.|Day 12-14||||Patients|||Number
1231585|NCT00652834|Primary|GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score|"The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms."|one month||||GSRS score||95% Confidence Interval|Mean
1231586|NCT00652743|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Month 12 up to Month 48)|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231587|NCT00652743|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231588|NCT00652743|Secondary|Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)|Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004.|At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
1231589|NCT00652743|Secondary|Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)|Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005.|At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
1231590|NCT00652743|Secondary|Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004.|At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
1231591|NCT00652743|Secondary|Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005.|At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
1231592|NCT00652743|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (From Month 12 to Month 48)|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1231725|NCT00651040|Primary|The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.|The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.|1 year||||mg/kg||Standard Deviation|Mean
1231593|NCT00652743|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptom|Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who has their symptom sheets filled in.|||Participants|||Count of Participants
1231594|NCT00652743|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
1231595|NCT00652743|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off|Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.|At Months 6/12/36 + 21 days, 12, 24, 36 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231596|NCT00652743|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Indonesia/05/2005.|At Months 6/12/36 + 21 days, 12, 24, 36 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231597|NCT00652743|Secondary|Booster Vaccine Response for Neutralizing Antibodies|Booster vaccine response was defined as: for pre-booster antibody titer < 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 6/12/36 + 21 days, 12, 24, 36 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231598|NCT00652743|Secondary|Titers for Serum Neutralizing Antibodies|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 6/12, 6/12 + 21 days, 24, 36 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1231599|NCT00652743|Secondary|Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies|Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 36, 42 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231600|NCT00652743|Secondary|Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies|Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24 and 30|The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.|||Participants|||Count of Participants
1231601|NCT00652743|Secondary|Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 36, 42 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
1231602|NCT00652743|Secondary|Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24, 30|The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.|||Fold change||95% Confidence Interval|Geometric Mean
1231886|NCT00650260|Secondary|Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.|Average core body temperature measured with an esophageal probe at 60 minutes post-induction|60 minutes post anesthesia induction||||degrees celcius||Standard Deviation|Mean
1231603|NCT00652743|Secondary|Booster Vaccine Response for H5N1 HI Antibodies|Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 36, 42 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231604|NCT00652743|Secondary|Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies|Seroconversion was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24 and 30|The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.|||Participants|||Count of Participants
1231605|NCT00652743|Secondary|Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12|Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24 and 30|The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.|||Participants|||Count of Participants
1231606|NCT00652743|Secondary|Number of Seropositive Subjects for H5N1 HI Antibodies|Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 42 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231607|NCT00652743|Secondary|Number of Seropositive Subjects for H5N1 HI Antibodies|Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24, 30 and 36|The analysis was performed on the ATP cohort for persistence at Month 12-18 (M12-18) and at Month 24-30 (M24-30), which included all evaluable subjects not boosted (M12-18) and boosted (M24-30) at M12, not boosted at M12 but boosted at M6 or neither boosted at M6 nor at M12 (M24-30).|||Participants|||Count of Participants
1231608|NCT00652743|Primary|Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease|Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231609|NCT00652743|Primary|Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease|Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 12 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231610|NCT00652743|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 36 +21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
1231611|NCT00652743|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 12 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
1231612|NCT00652743|Primary|Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36|Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).|At Month 36 + 21 Days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231887|NCT00650260|Primary|Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius||Intraoperative Period||||percentage of participants|||Number
1231613|NCT00652743|Primary|Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12|Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).|At Month 12 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231614|NCT00652743|Primary|Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1231615|NCT00652743|Primary|Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231616|NCT00652743|Primary|Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 12 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1231617|NCT00652743|Primary|Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 12 + 21 days|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1231618|NCT00652626|Primary|Number of Participants With Adverse Events (AEs)|"A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:~Results in death;~Is life threatening;~Requires inpatient hospitalization or prolongation of existing hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Is medically important.~The Investigator assessed each AE for potential causal relationship between the event and study drug.~The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5)."|Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).|Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment.|||participants|||Number
1231619|NCT00652626|Primary|Apparent Volume of Distribution of Azacitidine (Vz/F) After Single and Multiple Doses of Azacitidine|The apparent volume of distribution of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||liters||Geometric Coefficient of Variation|Geometric Mean
1231620|NCT00652626|Primary|Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine|The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
1231621|NCT00652626|Primary|Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine|The terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||hours||Geometric Coefficient of Variation|Geometric Mean
1231707|NCT00651313|Primary|The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.||Two 4-day dosing regimens for two consecutive monthy menstrual cycles|Time-weighted average pain intensity over the 4 treatment days using the 4 point categorical scale - none (0), mild (1), moderate (2), and severe (3); primary efficacy variable. ITT Analysis Set.|||units on a scale||Standard Deviation|Mean
1231622|NCT00652626|Primary|Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine|The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||hours||Full Range|Median
1231623|NCT00652626|Primary|Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine|The maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and for participants with severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1231624|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine|"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine, after a single dose (Day 1) and multiple doses (Day 5), calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:~AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant."|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1231625|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Time Point After Single and Multiple Doses of Azacitidine|The area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule for participants with normal renal function and for participants with severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1231626|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine|"The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function.~Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule."|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1231627|NCT00652626|Primary|Apparent Volume of Distribution of Azacitidine (Vz/F)|The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz)|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||liters||Geometric Coefficient of Variation|Geometric Mean
1231628|NCT00652626|Primary|Apparent Total Clearance of Azacitidine (CL/F)|The apparent total clearance of azacitidine after a single dose on Day 1, calculated as Dose/AUC0-inf.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
1231629|NCT00652626|Primary|Terminal Phase Half-life of Azacitidine (t½)|The terminal phase half-life of azacitidine after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||hours||Geometric Coefficient of Variation|Geometric Mean
1231630|NCT00652626|Primary|Time to Maximum Plasma Concentration of Azacitidine (Tmax)|The time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||hours||Full Range|Median
1231631|NCT00652626|Primary|Maximum Plasma Concentration of Azacitidine (Cmax)|The maximum observed plasma concentration of azacitidine after a single dose on Day 1.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1231708|NCT00651261|Secondary|DFS Rate One Year After Completing the Planned Continuation Phase||30 months|||||||
1231709|NCT00651261|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) is defined as the time from documentation of first CR at any time to the first of relapse or death from any cause in participants who achieved a CR.|Duration of study (Up to 10 years)||||months||95% Confidence Interval|Median
1231632|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity|"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine after a single dose, calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:~AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant."|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1231633|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point|Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1231634|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose|Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1231635|NCT00652366|Secondary|PFS Assessed From the Start of 4-Week Run-In|PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.|FAS; only participants with an event of PD or death were included in the analysis.|||weeks||95% Confidence Interval|Median
1231636|NCT00652366|Secondary|Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In|PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.|FAS|||percentage of participants|||Number
1231637|NCT00652366|Secondary|OS Assessed From Start of 4-Week Run-In|OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology.|BL and weekly thereafter for up to 46 months.|FAS|||months||95% Confidence Interval|Median
1231638|NCT00652366|Secondary|Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In|OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.|BL and weekly thereafter for up to 46 months.|FAS|||percentage of participants|||Number
1231639|NCT00652366|Secondary|Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST|Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS|||percentage of participants||95% Confidence Interval|Number
1231640|NCT00652366|Secondary|Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST|CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS|||percentage of participants||95% Confidence Interval|Number
1231641|NCT00652366|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST|BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS|||percentage of participants||95% Confidence Interval|Number
1231642|NCT00652366|Secondary|PFS Assessed From Point of Randomization|PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS|||weeks||95% Confidence Interval|Median
1231710|NCT00651261|Secondary|Complete Response Rate|Percentage of participants who achieved a complete response (CR). A CR was defined as normalization of blood counts and a marrow showing less than 5% blasts occurring on or before day 60.|Induction therapy (up to 60 days)||||percentage of participants||95% Confidence Interval|Number
1231643|NCT00652366|Secondary|Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization|Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS|||percentage of participants|||Number
1231644|NCT00652366|Primary|OS Assessed From Point of Randomization|OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS|||months||95% Confidence Interval|Median
1231645|NCT00652366|Primary|Percentage of Participants Who Died Assessed From Point of Randomization|Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|Full analysis set (FAS): all randomized participants.|||percentage of participants|||Number
1231646|NCT00652340|Secondary|Overall Survival||Randomization and every cycle||||months||95% Confidence Interval|Median
1231647|NCT00652340|Primary|Time to Disease Progression (TDP)||Baseline and every other cycle.|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.13 between the proportions of patients who are progression free in AP/E (0.34) and P/E (0.21) after 5 months; an overall sample size of 115 patients (77 in AP/E and 38 in P/E) will be randomized in a 2:1 ratio in this study.|||months||95% Confidence Interval|Median
1231648|NCT00652327|Primary|Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment||Assessed at the end of 8 weeks of treatment (from baseline to endpoint)|The population analyzed (intent-to-treat [ITT]) included all participants who had a post-randomization LDL-C laboratory evaluation. As such, 20 of the 83 participants who received treatment assignment were excluded from the ITT. The 5 participants who discontinued were included in the ITT as each had a post-randomization LDL-C lab evaluation.|||Percentage change||Standard Deviation|Mean
1231649|NCT00652314|Secondary|Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters||0 day, 30 day, and 60 days post procedure||||participants|||Number
1231650|NCT00652314|Secondary|Safety: Incidence Rate of Device-related Adverse Events||Procedure, up to 60 days post procedure||||participants|||Number
1231651|NCT00652314|Secondary|Effectiveness: Hemostatic Handling Characteristics (Surgeon’s Questionnaire)|Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics.|Procedure (application through end of procedure)|Note that the number of participants analyzed (62 and 33) applies to each set of five rows below which apply to the following categories: Ease of application to bleeding site, conformance to tissue surfaces, ease of delivery to hard to reach surfaces, and ease of preparation for use.|||participants|||Number
1231652|NCT00652314|Secondary|Effectiveness: Device Success (Defined as the Number of Subjects With First Bleeding Site Applications for Which Hemostasis Was Obtained Within 6 Minutes of Study Device Application Without the Need for Adjunctive Treatment)||Procedure, up to 6 minutes post procedure||||participants|||Number
1231653|NCT00652314|Primary|The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings.|Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.|Time to hemostasis (minutes)||||Time to hemostasis (minutes)||Standard Deviation|Mean
1231654|NCT00652145|Secondary|Fecal Calprotectin <200 µg/g||at 6 weeks after randomization|25 participants with baseline FC>=200ug/g|||participants|||Number
1231655|NCT00652145|Secondary|Fecal Calprotectin Level <100 µg/g||at 6 weeks after randomization|38 participants with baseline FC>=100ug/g|||participants|||Number
1231656|NCT00652145|Primary|Fecal Calprotectin Level <50µg/g||6 weeks after randomization||||participants|||Number
1231657|NCT00652093|Secondary|Final Pain|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
1231658|NCT00652093|Secondary|Swiss Spinal Stenosis Score- Physical Function|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
1231711|NCT00651261|Secondary|Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant|Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (Up to 10 years)||||months||95% Confidence Interval|Median
1231659|NCT00652093|Secondary|Swiss Spinal Stenosis Score- Symptom Severity|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.|study visit||||units on a scale||Standard Deviation|Mean
1231660|NCT00652093|Secondary|Oswestry Disability Index (ODI) Score|The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
1231661|NCT00652093|Secondary|Modified Brief Pain Inventory (mBPI)- Interference Score|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
1231662|NCT00652093|Secondary|Roland Morris Disability Questionnaire (RMDQ)|The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
1231663|NCT00652093|Secondary|Patient Global Assessment (PGA)|Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
1231664|NCT00652093|Secondary|Visual Analog Scale (VAS)|The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
1231665|NCT00652093|Secondary|Recovery Time|After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||minutes||Standard Deviation|Mean
1231666|NCT00652093|Secondary|Total Distance|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||meters||Standard Deviation|Mean
1231667|NCT00652093|Secondary|Area Under the Curve|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale * minutes||Standard Deviation|Mean
1231668|NCT00652093|Primary|Time to First Symptoms (Tfirst) of Moderate Pain|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.|study visit|The analyses included all 24 enrolled randomized subjects based on inclusion/exclusion criteria except for three who withdrew from trial prior to completion of study. One dropped out (physician decision) due to an adverse event (AE) (dizzy) and two dropped due to scheduling. This singular AE is not included in the AE reporting below.|||minutes||Standard Deviation|Mean
1231669|NCT00652028|Primary|Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl)|Number of subjects who received rescue medication for Sedation (Midazolam) and analgesics (Fentanyl) while intubated during Treatment Period|During the treatment period (Approximately 24 hours)|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||participants|||Number
1231681|NCT00651794|Secondary|Neonatal Resuscitation Program (NRP) Quality as Assessed by Resuscitation Duration|Resuscitation duration is time required to complete the resuscitation. The total duration for each resuscitation was calculated from the start of the instructor’s reading of the scenario to the team’s statement that the infant should be transferred to the NICU. When any teaching moments occurred during the simulation, the total teaching time was subtracted from the resuscitation duration.|During the megacode, which was performed about 1 hour after the training||||seconds||Standard Deviation|Mean
1232579|NCT00640315|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||hour||Full Range|Median
1231670|NCT00652028|Primary|Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score|"RSS Score range from 1 to 6:~Patient is anxious and agitated or restless, or both.~Patient is cooperative, orientated and tranquil.~Patient responds to command only.~Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus.~Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.~Patient exhibits no response to stimulus."|Prior to loading (Baseline), 5 and 10 min during the load, at start of maintenance infusion and every 15 min for 1 hour, hourly during the maintenance period, before and within 5 min after midazolam or fentanyl dose during the dexmedetomidine infusion.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||units on a scale||Standard Deviation|Mean
1231671|NCT00652028|Primary|Clearance (CL)|Clearance (CL) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||Litre/hour||Standard Deviation|Mean
1231672|NCT00652028|Primary|Volume of Steady State Distribution (Vss)|Volume of steady state distribution (Vss) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||Litre||Standard Deviation|Mean
1231673|NCT00652028|Primary|Plasma Concentration at Steady State (Css)|Plasma concentration at steady state (Css) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||picograms per milliliter||Standard Deviation|Mean
1231674|NCT00652028|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life (t1/2) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||hour||Standard Deviation|Mean
1231675|NCT00652028|Primary|Observed Peak Plasma Concentration|Observed peak plasma concentration (Cmax) for Dexmedetomidine|≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||picograms per milliliter||Standard Deviation|Mean
1231676|NCT00652028|Primary|Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞)|Area under the concentration-time curve from time zero to the time infinity (AUC0-∞) for Dexmedetomidine|≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||picograms*hr/mL||Standard Deviation|Mean
1231677|NCT00652028|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t)|Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for pharmacokinetic (PK) and pharmacodynamic (PD) analyses.|||picograms*hr/mL||Standard Deviation|Mean
1231678|NCT00651924|Primary|Comprehension|Each treatment session had 5 True / False questions that corresponded with the material in the patient handbook. Phase 1 participants reviewed individual treatment modules in the patient handbook to provide immediate feedback regarding how understandable, engaging, and informative they find the materials. Phase 2 participants’ used the patient materials as part of treatment and the true/false questions were used to evaluate comprehension of the materials. Example questions: Chronic pain can affect how you feel physically and emotionally (T); Relaxation is the same as being lazy and unproductive (F).|Immediately after review of materials (phase 1); 1 week post review of materials (phase 2)|Per protocol|||Percent of questions answered correctly||Standard Deviation|Mean
1231679|NCT00651820|Secondary|Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle|Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.|9 Months|Analysis performed on Intent-to-Treat (ITT) population|||mmHg/mm|Participants|Standard Deviation|Mean
1231680|NCT00651820|Primary|Time to Complete Wound Closure Collagenase Santyl and Vehicle||21 days|Analysis was performed on all subjects as intent-to-treat (ITT).|||Days|Participants|95% Confidence Interval|Mean
1231692|NCT00651625|Secondary|Physician Satisfaction|"0- 10 cm visual analogue satisfaction scale (VASS)~0-10 cm VASS at 2 weeks compared to 0-10 cm VASS pain scale at 0 weeks where 0= completely dissatisfied, and 10 = completely satsified. The difference (2 week VAS-0 week VAS) is the outcome measure"|during procedure||||cm||Standard Deviation|Mean
1231682|NCT00651794|Secondary|Neonatal Resuscitation Program (NRP) Quality as Assessed by NRP Performance Score|We analyzed 2 measures of NRP quality: performance score and resuscitation duration. The performance score was calculated by averaging the scores (ranging from 0 to 2 - higher values represent a better outcome) for each NRP step (some of which occurred multiple times). Those scores were summed and divided by the total possible score (2 times the number of steps that should have been performed). When a step was not indicated for the specific resuscitation scenario (e.g., meconium aspiration), that step was not scored by the observers and it was not included in the denominator for performance calculation. This produced a measure of performance percentage ranging from 0 percent to 100 percent (higher values represent a better outcome) for each resuscitation.|During the megacode, which was performed about 1 hour after the training||||performance percentage||Standard Deviation|Mean
1231683|NCT00651794|Secondary|Percentage of Time Spent on Vigilance|Vigilance percentage was calculated by summing the total time the team demonstrated vigilance behavior and dividing by the total resuscitation time.|During the megacode, which was performed about 1 hour after the training||||percentage of time||Standard Deviation|Mean
1231684|NCT00651794|Secondary|Percentage of Time Spent on Workload Management|Workload management percentage was calculated by summing the total time the team demonstrated workload management behavior and dividing by the total resuscitation time.|During the megacode, which was performed about 1 hour after the training||||percentage of time||Standard Deviation|Mean
1231685|NCT00651794|Primary|Teamwork Event Rate|The teamwork event rate was calculated by summing the number of scored teamwork events (sharing information, inquiry, assertion, teaching/advising, and evaluation of plans) and dividing by the total resuscitation time (in minutes).|During the megacode, which was performed about 1 hour after the training||||teamwork events per minute||Standard Deviation|Mean
1231686|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)|Per protocol, 18 participants were eligible for PK analysis.|||ng/mL*hr||90% Confidence Interval|Geometric Mean
1231687|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)|Per protocol, 18 participants were eligible for PK analysis.|||ng/mL*hr||90% Confidence Interval|Geometric Mean
1231688|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 patients eligible for PK analysis, two participants were excluded from the analysis due to data issues.|||ng/mL*hr||90% Confidence Interval|Geometric Mean
1231689|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.|||ug/mL*hr||90% Confidence Interval|Geometric Mean
1231690|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.|||ug/mL*hr||90% Confidence Interval|Geometric Mean
1231691|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.|||ug/mL*hr||90% Confidence Interval|Geometric Mean
1231693|NCT00651625|Secondary|Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation)||during procedure, 2 weeks afterwards, and 6 months afterwards||||participants|||Number
1231712|NCT00651261|Secondary|Event- Free Survival|"Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method.~Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint."|Duration of study (Up to 10 years)||||months||95% Confidence Interval|Median
1231713|NCT00651261|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (Up to 10 years)||||months||95% Confidence Interval|Median
1231714|NCT00651183|Primary|Change From Baseline in UPDRS Part III (Motor Examination)|14 components rating scale with 27 items scored by 0 (none) - 4 (severe)|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis|||Points on a scale||Inter-Quartile Range|Median
1231715|NCT00651183|Primary|Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.~It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale."|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis|||Points on a scale||Inter-Quartile Range|Median
1231716|NCT00651183|Primary|Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.~It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale."|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis|||Points on a scale||Inter-Quartile Range|Median
1231717|NCT00651183|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)|"Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement.~Total UPDRS part I score ranges from 0 = best score to 16 = worst score"|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis|||Points on a scale||Inter-Quartile Range|Median
1231718|NCT00651157|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|Time from registration to documentation of disease progression, assessed up to 5 years||||days||95% Confidence Interval|Median
1231719|NCT00651157|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
1231720|NCT00651157|Primary|Tumor Response|"A tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Every 4 weeks after 4 courses of treatment, assessed up to 5 years||||participants|||Number
1231721|NCT00651118|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days|"adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.~The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result."|day 1 to day 14|intent to treat( ITT)population (18 yrs of age or older) must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
1231722|NCT00651118|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result."|day 1 to day 14|intent to treat population (ITT)- must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
1231723|NCT00651118|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result."|days 1 to 14|intent to treat population (ITT)- must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
1231724|NCT00651040|Secondary|Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures||1 year||2016-12-31|12/2016||||
1231726|NCT00650858|Secondary|180 Day Follow-Up Glasgow Outcome Scale (GOS) Score|"180 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)"|180 days||||GOS score||Full Range|Median
1231727|NCT00650858|Secondary|180 Day Follow-Up Modified Rankin Scale (mRS) Score|"180 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)"|180 days||||mRS score||Full Range|Median
1231728|NCT00650858|Secondary|90 Day Follow-Up Glasgow Outcome Scale (GOS) Score|"90 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)"|90 days||||GOS score||Full Range|Median
1231729|NCT00650858|Secondary|90 Day Follow-Up Modified Rankin Scale (mRS) Score|"90 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)"|90 days||||mRS score||Full Range|Median
1231730|NCT00650858|Secondary|Average Daily Percentage Clot Size Resolution Over the First 3 Days|Daily IVH clot volume resolution, as a percentage of stability CT IVH volume, averaged over the first 3 days, determined by CT scans|3 days||||Percent of stability CT volume resolved||Full Range|Mean
1231731|NCT00650858|Primary|Rate of Symptomatic Bleeding Events|The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.|30-days||||participants|||Number
1231732|NCT00650858|Primary|Incidence of Bacterial Ventriculitis, Meningitis|The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.|30 days||||Number of participants|||Number
1231733|NCT00650858|Primary|30-day Mortality|The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.|30 days||||Number of participants|||Number
1231734|NCT00650845|Secondary|eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population|eGFR (estimated Glomerular Filtration Rate) was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.|Baseline pre MRI and 3 days post MRI|Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and a post- procedure blood sample for creatinine measurements) deprived of patients with protocol deviations/violations.|||Percentage of change from baseline||Standard Deviation|Mean
1231735|NCT00650845|Secondary|Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population|eGFR was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.|Baseline pre MRI and 3 days post MRI|Full analysis set population: all included patients with a pre and a post-procedure blood sample for creatinine measurements.|||Percentage of change from baseline||Standard Deviation|Mean
1231736|NCT00650845|Secondary|Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population|Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.|Baseline pre MRI and 3 days post MRI|Per protocol population. This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.|||Percentage of change from baseline||Standard Deviation|Mean
1231737|NCT00650845|Primary|Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.|Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.|Baseline pre MRI and 3 days post MRI|Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.|||Number of patients|||Number
1231738|NCT00650845|Secondary|Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.|Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.|Baseline pre MRI and 3 days post MRI|Full analysis set population:all included patients with a pre and post-procedure blood sample for creatinine measurement.|||Percentage of change from baseline||Standard Deviation|Mean
1231909|NCT00649792|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)|The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)|ITT Population. No imputation for missing data|||0-10 rating scale||Standard Deviation|Mean
1231739|NCT00650845|Primary|Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.|Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.|baseline pre MRI and 3 days post MRI|Full analysis set population: all included patients with a pre and post-procedure blood sample for creatinine measures.|||Number of patients|||Number
1231740|NCT00650806|Secondary|Change in Waist/Hip Ratio From Baseline to Week 12|The table below shows the mean change in waist/hip ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||ratio||Standard Deviation|Mean
1231741|NCT00650806|Secondary|Change in Hip Circumference From Baseline to Week 12|The table below shows the mean change in hip circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||cm||Standard Deviation|Mean
1231742|NCT00650806|Secondary|Change in Waist Circumference From Baseline to Week 12|The table below shows the mean change in waist circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||cm||Standard Deviation|Mean
1231743|NCT00650806|Secondary|Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12|The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1231744|NCT00650806|Secondary|Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12|The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1231745|NCT00650806|Secondary|Change in Body Mass Index (BMI) From Baseline to Week 12|The table below shows the mean change in BMI from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||kg/m2||Standard Deviation|Mean
1231746|NCT00650806|Secondary|Absolute Change in Body Weight From Baseline to Week 12|The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||kg||Standard Deviation|Mean
1231747|NCT00650806|Primary|Percent Change in Body Weight From Baseline to Week 12|The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Deviation|Mean
1231748|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231749|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231750|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231751|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231752|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231753|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231754|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231755|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231756|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231757|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231758|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231759|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231760|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231761|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231762|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231763|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231764|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231765|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231766|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231767|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231768|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231769|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231770|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231771|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231772|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231773|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231910|NCT00649792|Secondary|Clinician's Global Impression (CGI)|The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.|Visit 1 and every clinic visit thereafter|ITT Population. No imputation for missing data|||1-7 scale rating||Standard Deviation|Mean
1231774|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231775|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231776|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231777|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231778|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231779|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231780|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231781|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231782|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231911|NCT00649792|Secondary|Subject Global Impression (SGI)|For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.|Visit 1 and every clinic visit thereafter (other than the follow-up visit)|ITT Population. No imputation for missing data|||1-7 scale rating||Standard Deviation|Mean
1231783|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231784|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231785|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231786|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231787|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231788|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231789|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231790|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231791|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231912|NCT00649792|Secondary|Timed 25-Foot Walk (T25FW)||Week 2, 14, 26, continuing every 26 weeks until the Final Visit|ITT Population. No imputation for missing data|||feet/seconds||Standard Deviation|Mean
1232604|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1231792|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231793|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231794|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231795|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231796|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231797|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231798|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231799|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231800|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231913|NCT00649428|Primary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) and 6 months after last treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
1231801|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231802|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231803|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231804|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231805|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 16 (Follow-up)||Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
1231806|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 12||Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
1231807|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 8||Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
1231808|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 4||Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
1231809|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 2||Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
1231810|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 1||Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
1231811|NCT00650767|Secondary|C-Reactive Protein (CRP) at Baseline||Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
1231812|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231813|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1236810|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1231814|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231815|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231816|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231817|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231818|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231819|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231820|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231927|NCT00649220|Secondary|Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.|See #1 and #8. Change of <0 reveals a reduction of AP compared to baseline.|Week 8-20 post Baseline|"Intention to treat (ITT).~Week 8: n=16; Week 12: n=14; Week 16: n=13; Week 20: n=15"|||Percent of daily dose [DDD]||Standard Deviation|Mean
1231821|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231822|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231823|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231824|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231825|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231826|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231827|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231828|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231840|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231829|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231830|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231831|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231832|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231833|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231834|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231835|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231836|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231837|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231838|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231839|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1232133|NCT00644592|Primary|Log(ENA-Period 2 End/ENA Period 1 End)|"Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.~Natural logs used"|week 12 to week 4|Intent was to enroll 30 but drug was withdrawn by provider, with only 11 completing both experimental periods|||Log of Ratio||Standard Deviation|Mean
1231841|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231842|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231843|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231844|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231845|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231846|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231847|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231848|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231849|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231850|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231881|NCT00650546|Primary|Number of Patients With Improvement in Liver Histology After Treatment With Exenatide|Number of patients with liver histology improved with exenatide. The improvement of liver histology was defined as (1) no worsening of the fibrosis score, (11) improved score by at least one point in hepatocyte ballooning, and (111) either (a) improvement in NAS (NAFLD Activity Score) by two points spread across as least two of the three NAS components, or by (B)post-treatment NAS<3.|between baseline and 24-28 weeks after initiating treatment||||participants|||Number
1231851|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231852|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231853|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1231854|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231855|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231856|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231857|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231858|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231859|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231860|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231882|NCT00650260|Primary|Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius|Percent of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C|Upon entry to the post anesthesia care unit||||Percentage of participants|||Number
1231861|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231862|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231863|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231864|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231865|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231866|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231867|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231868|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231869|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231870|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
1231883|NCT00650260|Primary|Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C.||Temp taken just prior to surgery|Per protocol, sample size calculations indicate that a total sample size of 42 patients will be necessary to evaluate the primary outcome at an adjusted alpha = 0.05 with 80% power.|||Percentage of participants|||Number
1231871|NCT00650767|Primary|American College of Rheumatology 20% (ACR20) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.|||percentage of participants||95% Confidence Interval|Number
1231872|NCT00650585|Primary|Self-reported Lifetime Inhalant Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
1231873|NCT00650585|Primary|Self-reported Lifetime Marijuana Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
1231874|NCT00650585|Primary|Self-reported Lifetime Cigarette Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
1231875|NCT00650585|Primary|Self-reported Lifetime Alcohol Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
1231876|NCT00650585|Primary|Self-reported 30-day Inhalant Use|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used inhalants in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
1231877|NCT00650585|Primary|Self-reported 30-day Marijuana Use|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used marijuana in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
1231878|NCT00650585|Primary|Self-reported 30-day Use of Cigarettes|Students completed an 81-item self-report questionnaire. They were asked on how many days they had smoked cigarettes in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
1231879|NCT00650585|Primary|Self-reported 30-day Use of Alcohol|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used alcohol in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||Participants|||Number
1231880|NCT00650546|Primary|Change in NAS|The NAFLD Activity Score (NAS) is an underweight sum of steatosis (score 0-3), inflammation (score 0-3), ballooning scores (0-2). The NAS can range from 0-8 with the higher score indicating more aggressive disease.|Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.||||units on a scale||Standard Deviation|Mean
1231884|NCT00650260|Secondary|Median Post Anesthesia Care Unit Sublingual Temperature||Upon arrival to the post anesthesia care unit||||Degrees Celcius||Full Range|Median
1231885|NCT00650260|Secondary|Average Intraoperative Esophageal Temperature|Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia.|Intraoperative 0-70 minutes||||Degrees Celcius||Full Range|Mean
1231888|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Maintained Responder Population. Various n values are the result of participant attrition."|||participants|||Number
1231889|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Responder Population. Various n values are the result of participant attrition."|||participants|||Number
1231890|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition."|||participants|||Number
1231891|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Maintained Responder Population. Various n values are the result of participant attrition."|||points on a scale||Standard Deviation|Mean
1231892|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Responder Population. Various n values are the result of participant attrition."|||points on a scale||Standard Deviation|Mean
1231893|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition."|||points on a scale||Standard Deviation|Mean
1231894|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Months 3, 9, 15, 27, and 78|Maintained Responder : subset of the Responder Population, which was maintained or further decreased for a minimum of 4 weeks whilst the participant received a stable or decreasing dose of study medication. Various “n” values are the result of participant attrition.|||points on a scale||Standard Deviation|Mean
1231895|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Months 3, 9, 15, 27, and 78|Responder: a subset of the ITT Population containing those participants who had a score of 1 (very much improved) or 2 (much improved) on the clinical global impression (CGI) scale during the study. CGI-I scores (1 to 7 [very much worse]) the participant’s condition relative to baseline. Various “n” values are the result of participant attrition.|||points on a scale||Standard Deviation|Mean
1231914|NCT00649428|Secondary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
1231896|NCT00650104|Primary|Number of Participants With the Indicated Number of Adverse Events (AEs)|AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.|Every study visit from baseline to market availability (Month 78)|"All participants who received at least one dose of study medication. The treatment-emergent Study 196 AEs were defined as occurring during initial titration or long-term treatment or follow up."|||participants|||Number
1231897|NCT00650104|Primary|Unified Parkinson’s Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one treatment period evaluation for any parameter were included in the evaluation of the therapeutic benefit. Various “n” values are the result of participant attrition.|||points on a scale||Standard Deviation|Mean
1231898|NCT00650091|Post-Hoc|Change in Forced Vital Capacity|Change from Baseline in Forced Vital Capacity at 15, 30, 45, and 60 weeks (units in liters)|Baseline, 15, 30, 45, 60 week|Analysis population includes participants from the amended study design only.|||liters||Standard Deviation|Mean
1231899|NCT00650091|Secondary|Number of Participants With Maintained Forced Vital Capacity Response|Maintained forced vital capacity response was a binary variable taking on a value of 1 for participants with higher FVC % predicted at week 60 compared to baseline.|Measured at Week 60|Analysis population includes participants from the amended study design only.|||participants|||Number
1231900|NCT00650091|Secondary|Respiratory Infections||Measured at Week 60|Analysis population includes participants from the amended study design only.|||events|||Number
1231901|NCT00650091|Secondary|Acute Exacerbations|"The following 3 criteria will define acute exacerbations in subjects with acute worsening of their respiratory conditions:~1. Clinical (all of the following required): A) Unexplained worsening of dyspnea or cough within 30 days, triggering unscheduled medical care (e.g., emergency room, clinic, study visit, hospitalization). B) No clinical suspicion or overt evidence of cardiac event, pulmonary embolism, or deep venous thrombosis to explain acute worsening of dyspnea. C) No pneumothorax."|Measured at Week 60|Analysis population includes participants from the amended study design only.|||events|||Number
1231902|NCT00650091|Secondary|Disease Progression|"The time-to-death or a 10% decline in FVC will be defined as the time-to-disease progression.~The 10% decline in FVC from enrollment must be confirmed on 2 consecutive visits no less than 6 weeks apart. For subjects with 2 consecutive visits with a 10% decline in FVC, the time-to-disease progression will be defined as the time interval between enrollment and the initial visit with a 10% FVC decline."|Measured at Week 60|Analysis population includes participants from the amended study design only.|||percentage of participants||95% Confidence Interval|Number
1231903|NCT00650091|Primary|Overall Change in Forced Vital Capacity|Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters)|Measured as the estimated change from baseline to Week 60|Analysis population includes participants from the amended study design only.|||liters||95% Confidence Interval|Mean
1231904|NCT00650078|Secondary|Relative Reduction of Morning Stiffness|Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0).|Week 12|Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. Excludes those participants with missing data. Analysis used last observation carried forward imputation.|||Relative Change from Baseline (%)||95% Confidence Interval|Median
1231905|NCT00650078|Primary|ACR 20 Response Rate at Visit 4|"Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria:~> 20% reduction in the tender joint count (0-28)~> 20% reduction in the swollen joint count (0-28)~> 20% reduction in 3 out of the 5 following additional measures:~Patient’s assessment of pain~Patient’s global assessment of disease activity~Physician’s global assessment of disease activity~Functional Disability Index of the Health Assessment Questionnaire~C-reactive protein or erythrocyte sedimentation rate"|Week 12|Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. All missing values were imputed as non-responders.|||participants|||Number
1231906|NCT00649961|Secondary|To Define the Pharmacokinetic Profile of Melatonin in Preterm Infants.||6 months|||||||
1231907|NCT00649961|Primary|To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother.||6 months||||pg/ml||Full Range|Median
1231908|NCT00649792|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|up to 40 months|Safety Population. No imputation for missing data|||participants|||Number
1231915|NCT00649428|Secondary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
1231916|NCT00649428|Primary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) and 6 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
1231917|NCT00649389|Secondary|Change in Seated Systolic Blood Pressure From Baseline to Week 12||Baseline to week 12||||mm Hg||Standard Deviation|Mean
1231918|NCT00649389|Secondary|Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination||Baseline to 12 weeks or early termination|The ABPM Analysis Set included 440 subjects who provided consent to participate in the ABPM sub-study and who were to provide ABPM measurements prior to and after randomization. Those analyzed is the number who had values at both baseline and 12 weeks or early termination|||mm Hg||Standard Deviation|Mean
1231919|NCT00649389|Secondary|Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks||Baseline to 12 weeks|The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of seated diastolic blood pressure|||Percentage of subjects|||Number
1231920|NCT00649389|Primary|Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).||baseline to 12 weeks|The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of SeDBP|||mm Hg||Standard Deviation|Mean
1231921|NCT00649220|Secondary|Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.|"VAS is a report device to measure the subject’s burden caused by behavioral symptoms. To measure the burden on the VAS only the first 3 items of the Neuropsychiatric Inventory (NPI) Questionnaire were considered (delusions, hallucinations (visual and auditory), and agitation / aggression). The VAS consists of a 100 mm horizontal line, anchored at the ends with the reference “not at all” and “extremely. The VAS score was determined by measuring in mm from the left hand end of the line to the point, where the investigator had marked the magnitude of a subject’s burden."|Week 8-20 post Baseline|"Intention to treat (ITT).~Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18"|||Units on a scale [cm]||Standard Deviation|Mean
1231922|NCT00649220|Secondary|Change of Nurses’ Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20|"NOSGER is a comprehensive scale, which contains 30 items of behavior, each rated on a 5-point scale according to the frequency of occurrence by direct observation. Item scores are summarized into 6 dimension scores: memory, instrumental activities of daily life, self-care, mood, social behavior, and disturbing behavior. The NOSGER has a scoring range of 30 to 150 with the higher scores indicating worse subject’s status. The items in each group are rated for their frequency ranging from 1 (never) to 5 (always).~A change of <0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"|||Units on a scale||Standard Deviation|Mean
1231923|NCT00649220|Secondary|Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20.|"The modified ADCS-ADL19 is comprehensive battery of ADL questions aimed to measure the functional ability of subjects with Dementia of Alzheimer’s type over a broad range of dementia severity. It has a scoring range of 0 to 54 with the lower scores indicating greater functional impairment. Each ADL item was rated from the highest level of independent performance to complete loss.~Change of >0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18"|||Units on a Scale||Standard Deviation|Mean
1231924|NCT00649220|Secondary|"Change of Test for the Early Detection of Dementia With Discrimination From Depression [TE4D] Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression"|"TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The second part consists of a proxy rating and a self-assessment rating. The scoring range of each rating is 1 to 10. The maximum total score of 10 corresponds to severe depression.~A change <0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"|||units on a scale||Standard Deviation|Mean
1231925|NCT00649220|Secondary|"Change of Test for the Early Detection of Dementia With Discrimination From Depression [TE4D] Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia"|"TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The first part consists of 9 items, which assess different symptoms associated with dementia such as memory, time-orientation, etc. The scoring range is 0 to 50 points. A score of 35 or lower is an indication of dementia.~A change >0 represents an improvement."|Week 4-20 post baseline|"Intent to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"|||units on a scale||Standard Deviation|Mean
1231926|NCT00649220|Secondary|Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.|MMSE is a brief, physician–administered scale, designed for measuring the cognitive functions, such as: orientation, memory, attention, naming, and comprehension. The scoring range of MMSE is 0 to 30 points. A score of 23 or lower is indicative of cognitive impairment. Change of >0 reveals an improvement compared to baseline.|Week 20 post baseline|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
1232605|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Expiratory Volume in 1 Second (FEV1)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1231928|NCT00649220|Primary|Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent.|VAS: see #8. Mean “percent of the total Defined Daily Dose (DDD)”, averaged over one week, was calculated. Total DDD was calculated as sum of DDD for each AP drug. DDD is the assumed average maintenance dose per day defined by WHO. The reduction of AP Δ [percent] was calculated as a difference between the mean total DDD recorded at baseline and the mean total DDD recorded at the respective week. Measurements from those post-baseline visits were taken into account only when the value of the VAS was not substantially worse compared to baseline.|Week 8-20 post baseline|Intention to treat (ITT)|||Percent of daily dose [DDD]||Standard Deviation|Mean
1231929|NCT00648908|Secondary|Expanded Disability Status Scale (EDSS)|"Each patient, based on their baseline neurological exam, are scored according to the EDSS~The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable."|Screening visit, visit 6 and every 24 months thereafter|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Mean
1231930|NCT00648908|Secondary|Clinician Global Impression of Change (CGIC)|"Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS.~The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse."|visit 1 and every clinic visit|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Mean
1231931|NCT00648908|Secondary|Subject Global Impression (SGI)|"Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS).~For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted."|visit 1 and every clinic visit|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Mean
1231932|NCT00648908|Secondary|Timed 25 Foot Walk (T25FW)||Week 2, 14, 26, continuing every 26 weeks until the Final Visit|ITT Population. No imputation for missing data|||feet/second||Standard Deviation|Mean
1231933|NCT00648908|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|up to 5 years|Safety Population. No imputation for missing data|||Participants|||Number
1231934|NCT00648895|Primary|Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).|Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).|Before treatment and after 10 weeks|Due to the small sample size, no efficacy conclusion could be made. 0 measured value primary outcome =Not applicable.|||Percentage||Standard Deviation|Mean
1231935|NCT00648167|Primary|The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)||28 days||||mg/dL||Standard Deviation|Mean
1231936|NCT00648115|Secondary|Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio)|overall economic impact, in dollars, will be evaluated by the following formula: income - healthcare cost - cost of incarceration|12 months||||dollars||Standard Deviation|Mean
1231937|NCT00648115|Primary|Time Till Employment in Days|Number of days until first day of competitive employment|12 months||||number of days to first employment||95% Confidence Interval|Mean
1231938|NCT00648037|Primary|Safety of Rituximab Prophylaxis|The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.|3 months post transplant|Please see Adverse Event section for more details.|||participants|||Number
1231939|NCT00647998|Secondary|Hemoglobin||24 hours post-surgery||||gm/dL||Standard Deviation|Mean
1231940|NCT00647998|Secondary|CSF S100beta|Cerebrospinal fluid S100beta level|48 hours||||pg/mL||Inter-Quartile Range|Median
1231941|NCT00647998|Primary|Death or Neurologic Disability, Defined as an National Institutes of Health Stroke Scale (NIHSS)>4 or American Spinal Injury Association (ASIA) Lower Extermity Motor Score <25|The NIHSS is a validated quasi-ordinal measure of stroke severity. An NIHSS >4 is generally considered moderate or severe. The ASIA Lower Extremity Motor Score is a cumulative total of assessments of strength in 5 muscles in each leg, using the Medical Research Council 0-5 stroke score. ASIA score < 25 is associated with impaired ambulation.|Discharge from the hospital||||Participants|||Count of Participants
1231942|NCT00647699|Primary|Mean Change From Baseline in Maximum Keratometry (Kmax)|The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.|baseline,12 months|The ITT (intent to treat) population consisted of all treated subjects, analyzed according to the treatment actually received. For the sham study eyes that received CXL treatment after baseline, the last Kmax measurement recorded prior to receiving CXL treatment was used in the analysis for later time points.|||diopters||Standard Deviation|Mean
1232029|NCT00645671|Secondary|Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|At each follow-up visit through day18 (Visit 7)|Intent to treat population|||participants|||Number
1231943|NCT00647556|Secondary|Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24|Number of participants in each category of the Investigator Evaluation of Global Response (Improvement) at week 12 and week 24. Investigator Evaluation of Global Response (Improvement) is evaluated on a scale from 0 - 6 (0 = Complete Response, 1 = Almost Complete (~90%) Response, 2 = Marked (~75%) Response, 3 = Moderate (~50%) Response, 4 = Slight (~25%) Response, 5 = No Response and 6 = Worsening) with 0 being best and 6 being worst.|week 12 and week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1231944|NCT00647556|Secondary|Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24|Number of participants in each category of the Subject Evaluation of Improvement at week 12 and week 24. Subject Evaluation of Improvement was evaluated on a scale from 0 - 6 (0 = Complete Improvement, 1 = Almost (~90%) Improvement, 2 = Marked (~75%) Improvement, 3 = Moderate (~50%) Improvement, 4 = Slight (~25%) Improvement, 5 = No Change, 6 = Worse) with 0 being best and 6 being worst.|week 12 and week 24|ITT (Intent to Treat; LOCF (Last Observation Carried Forward)|||participants|||Number
1231945|NCT00647556|Secondary|Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.|Number of participants who improved in Overall Integrated Assessment of Photodamage from baseline to week 12. Overall Integrated Assessment of Photodamage was evaluated on a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.|baseline to week 12|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1231946|NCT00647556|Secondary|Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24|Number of participants in each category of the Photonumeric Scale for the Assessment of Photodamage from baseline to week 12 and baseline to week 24. Photonumeric Scale consisted of 9 categories (Fine Wrinkling, Mottled Pigmentation, Irregular Depigmentation, Lentigines, Coarse Wrinkling, Elastosis, Tactile Roughness, Telangiectasia, and Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.|baseline, week 12 and week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1231947|NCT00647556|Primary|Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24|Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.|baseline to week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1231948|NCT00647400|Secondary|Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.|||Participants|||Number
1231949|NCT00647400|Secondary|Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.|||Participants|||Number
1231950|NCT00647400|Primary|Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.|||Participants|||Number
1231951|NCT00647270|Secondary|Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.|||units on a score||Standard Error|Least Squares Mean
1231952|NCT00647270|Secondary|Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.|||units on a score||Standard Error|Least Squares Mean
1231953|NCT00647270|Secondary|Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (LOCF).|||units on a score||Standard Deviation|Mean
1231954|NCT00647270|Secondary|Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (observed).|||units on a score||Standard Deviation|Mean
1231955|NCT00647270|Primary|The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)|Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit|Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.|||participants|||Number
1231956|NCT00646958|Secondary|Number of Patients With Per-Patient Microbiologic Response of Eradicated|The microbiological response at the patient level was considered Eradicated (documented or presumed)if no pathogens were present in repeat cultures taken from the original site of infection or a clinical response of cure precluded the ability to obtain a culturable specimen.|Test of Cure (TOC), day 10-20|Microbiologically Evaluable patients were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before TOC, presented for a TOC evaluation in the appropriate window, and who had a baseline pathogen that was susceptible to study drug.|||Participants|||Number
1231957|NCT00646958|Primary|Number of Participants With a Clinical Response of Cure|To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.|Test of Cure (TOC), day 10-20|Clinically Evaluable participants were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before Test of Cure (TOC), and who presented for a TOC evaluation in the appropriate window.|||Participants|||Number
1231958|NCT00646776|Secondary|Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings|Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic), and heart rate. Physical examination included a neurological examination (if ocular signs or symptoms occurred, a reflex to slit lamp exam was performed by an ophthalmologist). The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.|Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge|All treated participants.|||Participants|||Number
1231959|NCT00646776|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECG abnormalities were defined as findings that are clinically meaningful as judged by the investigator. A 12-lead ECG was recorded at least 5 minutes after the participant had been lying down and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.|Pre-dose on Day -1 and study discharge.|All participants who received the study drug on Day 1 were included in the analysis.|||Participants|||Number
1231960|NCT00646776|Secondary|Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs. Protein, glucose and blood: >=2+ (or, if pre-treatment value >=1+, then >= 2 x pre-treatment value).|Pre-dose on Day -1, Day 7 and discharge.|"All participants who received the study drug on Day 1 were included in the analysis. If a value had not evaluable in the dataset, then these participants were not counted (for all parameters: protein, glucose and blood)."|||Participants|||Number
1231996|NCT00646048|Secondary|Number of Participants Who Achieve Technical Success of the Stent Graft System.|Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.|Post procedure||||Participants|||Number
1231961|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 x LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8 x pre-Rx or >ULN. If pre-Rx >ULN, then >2.0 x pre-Rx or <LLN. Albumin: <0.9 x LLN (if pre-Rx <LLN, then <0.9 x pre-Rx). Creatine kinase: >1.5 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx). Uric acid: >1.2 x ULN (if pre-Rx >ULN, then >1.25 x pre-Rx). LDH: >1.25 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted(albumin, creatine kinase, uric acid and LDH)."|||Participants|||Number
1231962|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Chloride (serum), calcium (total), protein (total):<0.9xLLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN). Bicarbonate:<0.8xLLN or >1.2xULN (if pre-Rx value <LLN, then <0.8xpre-Rx value or >ULN. If pre-Rx >ULN, then >1.2xpre-Rx value or <ULN). Phosphorous (inorganic):<0.85xLLN or >1.25xULN (if pre-Rx <ULN, then <0.85xpre-Rx or <ULN. If pre-Rx >ULN, then >1.25x re-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|All treated participants.|||Participants|||Number
1231963|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, AST, ALT:>1.25xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Bilirubin (total), bilirubin (direct), BUN:>1.1xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Creatinine:>1.33xpre-Rx. Sodium (serum):<0.95xLLN or >1.05xULN (if pre-Rx <LLN, then <0.95xpre-Rx or >ULN. If pre-Rx >ULN, then >1.05xpre-Rx or <LLN). Potassium (serum):<0.9xLLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted (ALP, AST, ALT, bilirubin [total], bilirubin [direct], BUN and creatinine)."|||Participants|||Number
1231964|NCT00646776|Primary|Total Area Under the Plasma Concentration-time Curve (AUCtot)|AUCtot represents the total free RIB plus 25-O-Desacetyl-RIB output. It is calculated as: AUCtot (micromolar[µM]*h) = AUC24avg(RIB)(ng*h/mL)/847.016 (g/mole) + AUC24avg(25-O-Desacetyl-RIB)(ng*h/mL)/804.979(g/mole). The 300 mg RIB arm represents an extrapolation from the 150 mg RIB group.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|"All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis. The RIB 300 mg arm represents an extrapolation of the RIB 150 mg arm and as such, does not have a value for Number of Participants Analyzed. AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD."|||µM*h||Full Range|Geometric Mean
1231965|NCT00646776|Primary|Cmin of 25-O-Desacetyl-RIB|Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
1231966|NCT00646776|Primary|Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)|Cmax was derived from the plasma concentration versus time for 25-O-Desacetyl-RIB (a metabolite of RIB) and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
1231967|NCT00646776|Primary|AUC24avg for 25-O-Desacetyl-RIB|AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150 mg QD; AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng*h/mL||Full Range|Geometric Mean
1231968|NCT00646776|Secondary|Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils+bands (absolute): <=1.50 x 10^3 cells/microliter (uL). Lymphocytes (absolute): <0.75 x 10^3 cells/uL or >7.50 x 10^3 cells/uL. Monocytes (absolute): >2.00 x 10^3 cells/uL. Basophils (absolute): >0.40 x 10^3 cells/uL. Eosinophils (absolute): >0.75 x 10^3 cells/uL.|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted(neutrophils + bands [absolute], monocytes [absolute], basophils [absolute] and eosinophils [absolute])."|||Participants|||Number
1232485|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Parthenolide|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
1231969|NCT00646776|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin/hematocrit: <0.85 x pre-treatment (pre-Rx) value. Platelet count: <0.85 x lower limit of normal (LLN) (or, if pre-Rx value <LLN, then <0.85 x pre-Rx value) or >1.5 x upper limit of normal (ULN). Leukocytes: <0.9 x LLN or >1.2 x ULN (or, if pre-Rx value <LLN, then <0.85 x pre-Rx or >ULN. If pre-Rx value >ULN, then >1.15 x pre-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted (hemoglobin and hematocrit)."|||Participants|||Number
1231970|NCT00646776|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.|AEs were defined as new, untoward medical occurrences/worsening of pre-existing medical condition, whether drug-related or not. SAEs were defined as any AE that: resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose. Discontinuation from the study was due either to an AE or was conducted at the investigator's discretion.|From Day 1 to 30 days after the last dose of study drug.|All treated participants.|||Participants|||Number
1231971|NCT00646776|Secondary|T-half of RTV|T-half was obtained directly from the concentration-time data.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||Hour||Standard Deviation|Mean
1231972|NCT00646776|Secondary|Tmax of RTV|Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||Hour||Full Range|Median
1231973|NCT00646776|Secondary|AUC(TAU) for RTV|AUC(TAU) was derived from the plasma concentration versus time for RTV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||ng*h/mL||Full Range|Geometric Mean
1231974|NCT00646776|Secondary|Cmin of RTV|Cmin was derived from the plasma concentration versus time for RTV.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
1231975|NCT00646776|Secondary|Cmax of RTV|Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
1231976|NCT00646776|Secondary|Terminal Elimination Half-life (T-half) of ATV|T-half was obtained directly from the concentration-time data. T-half following doses administered for treatment ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||Hour||Standard Deviation|Mean
1231977|NCT00646776|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV|Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||Hour||Full Range|Median
1231978|NCT00646776|Secondary|AUC(TAU) for ATV|AUC(TAU) was derived from the plasma concentration versus time for ATV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||ng*h/mL||Full Range|Geometric Mean
1231979|NCT00646776|Secondary|Cmin of ATV|Cmin was derived from the plasma concentration versus time for ATV.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
1231980|NCT00646776|Secondary|Cmax of ATV|Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
1231981|NCT00646776|Primary|Minimum Plasma Concentration (Cmin) of RIB|Cmin was derived from plasma concentration versus time for RIB.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
1231982|NCT00646776|Primary|Maximum Plasma Concentration (Cmax) of RIB|Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
1231983|NCT00646776|Primary|Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)|AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150mg once daily (QD); AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7.|Pre-dose (0 hours [h]) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||nanograms*hour /milliliters (ng*h/mL)||Full Range|Geometric Mean
1231984|NCT00646763|Primary|Number of Participants for Whom Target Number of CD34+ Cells Were Collected.|Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment|7 days||||participants|||Number
1231985|NCT00646763|Secondary|Total Number of Days of Apheresis|the number of days of apheresis required to collect target numbers of CD34+ cells.|7 days||||days||Standard Deviation|Mean
1231986|NCT00646763|Primary|The Total Number of CD34+ Cells Collected.||4 days|Patients at our institution between the ages of 18 and 70 years old with relapsed or refractory Hodgkin’s disease, non-Hodgkin’s lymphoma, or mutiple myelomawhowere scheduled for an autologous HSCTwere eligible to participate in the study.|||cells per Kg||Standard Deviation|Mean
1231987|NCT00646646|Primary|Dynamic Eye Movement Measures|Change in Eye Movements Parameters|baseline to Sedation State (approx. 1 hr)||||(degrees/second)||95% Confidence Interval|Mean
1231988|NCT00646581|Primary|Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). False alarm rate refers to the proportion of overall attempts that were characterized as incorrect responses (responses to two non-identical targets). Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.|||Proportion of overall attempts||Standard Deviation|Mean
1231989|NCT00646581|Primary|Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). Reaction time of hits refers to the average time each participant took to correctly respond to a stimuli in milliseconds. Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.|||Milliseconds||Standard Deviation|Mean
1231990|NCT00646581|Primary|Improvement in Cognitive Function- CPT Hits Rate (Proportion)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in the previous outcome measure (CPT d score). Hits rate refers to each participant's ability to correctly respond to two consecutive target presentations (i.e. correct responses). Hits rate was measured as a proportion of overall attempts (0= no hits, 1.0= 100% accuracy on hits). Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized either to the experimental or placebo group.|||Proportion of overall attempts||Standard Deviation|Mean
1231991|NCT00646581|Primary|CPT d Score|"Subjects performed a computer-based test designed to measure sustained attention (attention to a specific stimuli over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.|||units on a scale||Standard Deviation|Mean
1231992|NCT00646581|Primary|Improvement in Cognitive Function- HVLT-Delayed Recall (Number)|Subjects performed the HVLT word recall task after a 20-minute delay before and after intranasal treatment. In the HVLT delayed recall task, participants were asked to recall the same list of 12 words dictated in the immediate recall task 20 minutes after the completion of the immediate recall task. Words successfully recalled after the 20-minute delay were measured. Values below represent posttreatment performance minus pretreatment performance.|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed in this study. Subjects were randomized to either the experimental or placebo group.|||Words successfully recalled||Standard Deviation|Mean
1231993|NCT00646581|Primary|Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)|Subjects performed the HVLT Immediate Recall Task. For this task, participants were read aloud a list of 12 words from three taxonomic categories. Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could. The number of words recalled successfully was measured before and after intranasal treatment. Values below represent posttreatment performance minus pretreatment performance.|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.|||Words successfully recalled||Standard Deviation|Mean
1231994|NCT00646399|Primary|The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.|Safety and efficacy|35 days|1579 very low birth weight subjects were included in the ITT.|||Participants|||Number
1231995|NCT00646282|Primary|Number of Subjects With 50% Reduction of Intact Parathyroid Hormone (iPTH) Levels|Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months|18 months|Data not analyzed due to study termination||||||
1231997|NCT00646048|Primary|Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).|A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.|1 month||||Participants|||Number
1231998|NCT00646048|Primary|Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.|Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.|1 month||||Participants|||Number
1231999|NCT00645970|Primary|Numeric Rating Scales of Pain Over Past Week (11 Point Likert Scale)|Numeric Pain Rating Scale is a self-report measure of “usual” (average) pain intensity over the last week; response options range from “no pain” (0) to “worst pain imaginable” (10). A score >3 indicates moderate-to-severe pain.|Baseline, 6 months, 1 year|Numeric Pain Rating Scale data are missing for 21 participants (PSC n=1; Registry n=20)|||units on a scale||Standard Deviation|Mean
1232000|NCT00645944|Primary|Change in Insomnia Severity Index From Baseline.|The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach’s alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.|8 Weeks|Of 39 eligible participants, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication. 36 participants were included in the modified ITT analysis|||units on a scale||95% Confidence Interval|Least Squares Mean
1232001|NCT00645853|Secondary|AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment||154-711 days on treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis|||nmol/L||Full Range|Median
1232002|NCT00645853|Secondary|AZD0837: Plasma Concentration of AZD0837 at End of Treatment||End of treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis|||nmol/L||Full Range|Median
1232003|NCT00645853|Secondary|Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment||Baseline and End of Treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis|||sec||Full Range|Median
1232004|NCT00645853|Secondary|Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment|Median Full range, Seconds|Baseline and End of treatment|Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis|||sec||Full Range|Median
1232005|NCT00645853|Secondary|D-dimer:Median and Quartile Range at End of Treatment|Median (Lower Quartile-Upper Quartile ), ng/mL|End of treatment|Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis|||ng/mL||Inter-Quartile Range|Median
1232006|NCT00645853|Secondary|Creatinine: Absolute Change From Baseline, at End of Treatment||Baseline and End of treatment||||µmol/L||Full Range|Mean
1232007|NCT00645853|Secondary|Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline||From baseline to Follow up||||Participants|||Number
1232008|NCT00645853|Secondary|Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline|ULN=Upper limit of Normal|From baseline to Follow up||||Participants|||Number
1232009|NCT00645853|Primary|Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period|Participants|154-711 days on treatment||||Participants|||Number
1232010|NCT00645827|Secondary|Hypoglycemia (Serum Blood Glucose < 70 mg/dL)||Within 24 hours after cessation of IV insulin|||||||
1232011|NCT00645827|Primary|Percentage of Blood Glucose Values Within 80-140 mg/dL|Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL|Within 24 hours after cessation of IV insulin||||percentage of blood glucose values|||Number
1232012|NCT00645788|Secondary|Number of Participants With the Occurrence of Drug Induced Bronchospasms|"Bronchospasm reported as adverse event: Bronchospasm defined as >=15% drop in FEV1, and may also include allergic and excercise-induced bronchospasm. Drug-induced bronchospasm: Treatment-emergent bronchospasm was defined as >=15% drop in FEV1 in the ITT/safety population. Note: One of the bronchospasm events was considered a serious adverse event, and it was not included under other adverse events. A sum of bronchospasm events was 1+6=7."|Up to visit 9 (Day 56-60)|Intent to treat|||participants|||Number
1232013|NCT00645788|Secondary|Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment|Sputum concentrations measured using validated HPLC-MS/MS methods in selected patients to contribute kinetic information for an inter-study population sputum kinetic evaluation. Number of samples vary at different time points.|Up to visit 7 (Day 28-30)|Analysis was not performed due to insufficient data.||||||
1232014|NCT00645788|Secondary|Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment|Plasma concentrations measured using validated high pressure liquid chromatography-mass specroscopy/mass spectroscopy (HPLC-MS/MS) methods in selected patients at predefined time windows to contribute pharmacokinetic (PK) information for an inter-study population PK evaluation. Sampling window for Plasma: Predose (trough level), <15 min, 2.0 - 2.5 hour, and 4.0 - 7.0 hours after the end of inhalation. Number of samples vary at different time points.|Up to visit 7 (Day 28-30)|Analysis was not performed due to insufficient data.||||||
1232028|NCT00645671|Secondary|Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Baseline and each follow-up visit through day18 (Visit 7)|Intent to treat population|||Composit scores||Standard Deviation|Mean
1232015|NCT00645788|Secondary|Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale|The CF quality of life questionnaire revised (CFQ-R), a validated disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). It is self-administered and consists of 44 items, divided into 12 generic and disease-specific scales. The scale includes physical functioning, role, vitality, emotional functioning, social functioning, body image, eating disturbances, treatment burden, health perceptions, weight, respiratory symptoms, and digestive symptoms. Scale range: 0 to 100 (maximum). Better outcome with higher values.|Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60)|Intent to treat|||scores on a scale||Standard Deviation|Mean
1232016|NCT00645788|Secondary|Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates|Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The “susceptible” bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy.|Baseline and up to visit 9 (day 56-60)|Intent to treat|||Participants|||Number
1232017|NCT00645788|Secondary|Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates|Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The “susceptible” bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy.|Baseline and up to visit 9 (day 56-60)|Intent to treat|||Participants|||Number
1232018|NCT00645788|Secondary|Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9|FEF 25-75% (also known as the maximum midexpiratory flow [MMEF]): The mean forced expiration flow over the middle half of the forced vital capacity (FVC). It was taken from the blow with the largest sum of FEV1 and FVC. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat|||Percent of predicted FEF 25-75%||Standard Deviation|Mean
1232019|NCT00645788|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9|FVC: The maximal volume of air exhaled with maximally forced effort from a maximal inspiration, ie, vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS (body temperature and ambient pressure saturated with water vapor). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat|||Percent of predicted FVC||Standard Deviation|Mean
1232020|NCT00645788|Secondary|Time to First Pulmonary Exacerbation Requiring Intervention|Pulmonary exacerbations: Assessment of pulmonary exacerbation was conducted by the treating physician as part of the physical examination. Pulmonary exacerbation was defined by chest examination findings and any or all of the following symptoms: decreased exercise tolerance, increased cough, increased sputum/cough congestion, school or work absenteeism, increased adventitial sounds on the lung examination, and decreased appetite.|Up to visit 9 (Day 56-60)|Intent to treat|||Days||Inter-Quartile Range|Median
1232021|NCT00645788|Secondary|Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9|Density of P. aeruginosa in the sputum is expressed as log10 of colony forming units (CFU)/gram (g). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat|||log10(cfu/g)||Standard Deviation|Mean
1232022|NCT00645788|Secondary|Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9|FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat|||Percent of predicted FEV1||Standard Deviation|Mean
1232023|NCT00645788|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28‑30|FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and End of treatment (Day 28-30)|Intent to treat|||Percent of predicted FEV1||Standard Deviation|Mean
1232024|NCT00645762|Primary|Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement|"Symptomatic change in SNOT 20 scores on a 5-point Likert scale where 0 = no problem to 5 = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful."|Post-treatment through 12 months|Score reduction in SNOT 20 Scale Scores. Baseline through 12 months post-procedure.|||Scores on a scale|||Number
1232025|NCT00645762|Primary|Patency of the Treated Area as Verified by CT Scan|Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.|Post-treatment at 3 months|Analysis of ostia patency done per protocol|||Ostia|Participants||Number
1232026|NCT00645762|Primary|Incidences of Device-related or Procedure-related Complications||Through 12 months post-procedure|Patients completing 12 month follow-up|||participants|||Number
1232027|NCT00645671|Primary|Grade 0 for Pain|Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe|Postoperative Day 8 (Visit 5)|Intent to treat population|||participants|||Number
1232030|NCT00645671|Primary|Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative Day 8 (Visit 5)|Intent to treat population|||participants|||Number
1232031|NCT00645593|Secondary|Median Overall Survival in Months|Median overall survival in months is provided. One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval.|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.|||Months||95% Confidence Interval|Median
1232032|NCT00645593|Secondary|Median Progression-free Survival Time in Months|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.|||months||95% Confidence Interval|Median
1232033|NCT00645593|Secondary|The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2|"One of the secondary outcomes was to assess the safety and tolerability of treatment for both arms.~The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for adverse event reporting."|3 years|Although 60 participants were enrolled and randomized to arm 2, 1 participant withdrew consent prior to treatment and was therefore excluded from toxicity analysis.|||adverse events|||Number
1232034|NCT00645593|Primary|Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2|"The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab.~Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest diameter of target lesions)."|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
1232035|NCT00645567|Primary|Shoulder Force|measurement of applied shoulder force during wheelchair transfers|None reported - verifiable data is not available for any of the participants|As of the November 2012 update to the IRB, there were no findings at that point. At this time, verifiable data is not available for any of the participants.||||||
1232036|NCT00645528|Primary|Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here."|Visit 2 (week 2)||||units on a scale||Standard Deviation|Mean
1232037|NCT00645528|Primary|Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here."|Visit 1 (week 0)||||units on a scale||Standard Deviation|Mean
1232038|NCT00645528|Secondary|Number of Patients Experiencing a Severe Hypoglycemic Event|Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia|2 weeks||||participants|||Number
1232039|NCT00645528|Secondary|Number of Subjects Experiencing Hypoglycemic Symptoms|Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits|2 weeks|As below, 15 subjects reported subjective symptoms of hypoglycemia in the two weeks between study visits; 10 of these subjects had at least one recorded blood glucose value less than 70 mg/dl; Eight of these 10 subjects had started insulin.|||participants|||Number
1232040|NCT00645528|Secondary|Percent of Patients Who Begin Insulin||2 weeks||||percentage of participants|||Number
1232051|NCT00645411|Secondary|Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV.~GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
1232442|NCT00641056|Secondary|Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26|Change in HDL (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
1232041|NCT00645528|Primary|"Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes"|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test."|2 weeks|32 subjects completed the study|||units on a scale||Standard Deviation|Mean
1232042|NCT00645411|Secondary|Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.|To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.|up to 7 days after each vaccination|The analysis was performed on the safety dataset set.|||Subjects|||Number
1232043|NCT00645411|Secondary|Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.|To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .|up to 7 days after vaccination|The analysis was performed on the safety dataset|||Subjects|||Number
1232044|NCT00645411|Secondary|Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children|"Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.~According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%."|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
1232045|NCT00645411|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children|"To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart.~The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%."|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
1232046|NCT00645411|Secondary|Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children|"To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria.~The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is >2.5"|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.|||Ratio||95% Confidence Interval|Geometric Mean
1232047|NCT00645411|Secondary|Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children|To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
1232048|NCT00645411|Secondary|Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.~According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
1232049|NCT00645411|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine.~This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
1232050|NCT00645411|Secondary|Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.|"Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is >2.5."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.|||Ratio||95% Confidence Interval|Geometric Mean
1232643|NCT00640224|Secondary|Morning Blood Pressure at Baseline and 6 Months|Morning blood pressure was measured with an automated sphygmomanometer.|Baseline and 6 months||||mm Hg||Standard Error|Mean
1232052|NCT00645411|Primary|Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children|"To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age.~Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay."|Day 50 post vaccination|The analysis was performed on the per-protocol dataset|||Percentages of subjects||95% Confidence Interval|Number
1232053|NCT00645411|Primary|Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children|"To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age.~GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay."|Day 50 post vaccination|The analysis was performed on the per-protocol dataset|||Titers||95% Confidence Interval|Geometric Mean
1232054|NCT00645359|Primary|The Odds Ratio (OR) Between Tumor Response (Based on Changes in MR Imaging) and Duration of Response|To correlate the changes on MR images with the tumor response after completion of chemotherapy and duration of response. Tumor response will be determined by the clinical evaluation, tumor dimensions, and metabolic response as assessed by 18-Fluoro-deoxy.|2 years|No patients were analyzed due to insufficient resources, secondary to shifting research priorities.||||||
1232055|NCT00645359|Primary|Mean Difference in Apparent Diffusion Coefficient|To assess whether changes in the apparent diffusion coefficient (ADC) during the early phase of chemotherapy are detectable in lymphoma, the ADC value will be calculated at the voxel level, on baseline and Day 8, and the mean difference will be calculated.|Baseline and Day 8|No patients were analyzed due to insufficient resources, secondary to shifting research priorities.||||||
1232056|NCT00645333|Primary|Maximum Tolerated Dose (MTD)|The Maximum Tolerated Dose (MTD) for MK-0752 will be determined. Dose levels were: Level 1: 300 mg MK-0752 by mouth days 1-3; Level 2: 450 mg MK-0752 by mouth days 1-3; Level 3: 600 mg MK-0752 by mouth days 1-3; Level 4: 800 mg MK-0752 by mouth days 1-3.|Up to 3 years||||mg|||Number
1232057|NCT00645333|Primary|Dose Limiting Toxicity (DLT)|"The number of DLTs experienced by participants within the first 21 days.~DLTs were defined as toxicities possibly, probably, or definitely related to the study drug observed during the first 2 cycles (first 42 days) as follows:~Non-hematologic toxicity Grade ≥3 by the NCI CTCAE version 3.0.~ANC<1000 for more than 7 days despite use of pegfilgrastim.~Platelet count <25,000 for more than 7 days, or associated with bleeding, or less than 10,000 at any time."|first 21 days||||Dose Limiting Toxicities|||Number
1232058|NCT00645164|Primary|Frequency Distribution of Skin Irritation Scores|Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.|48-hours post irradiation|Analysis was based on number of subjects who completed the study.|||Scores on a scale|||Number
1232059|NCT00645099|Secondary|Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS)|PANSS is an investigator-rated 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provided a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).|Baseline to End Point (up to 6 months)|The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||points on a scale||Standard Deviation|Mean
1232060|NCT00645099|Secondary|Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up|"Metabolic syndrome is defined according the Third Report of the National Cholesterol Education Program Expert Panel on~Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII) of which 3 out of 5 criteria must be met:~waist circumference men > 102 cm; waist circumference women > 88 cm~TG ≥ 150 mg/dL~HDL cholesterol men <40 mg/dL; HDL cholesterol women <50 mg/dL~Blood pressure systolic ≥ 130 mmHg; Blood pressure diastolic ≥ 85 mmHg~Fasting glucose ≥ 110 mg /dL"|6 months|The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. In this case, the total number of patients in the analysis set depends on the number of patients without metabolic syndrome at baseline.|||Participants|||Number
1232061|NCT00645099|Secondary|Change From Baseline at End Point in Waist Circumference|Patients had to be instructed to stand erect with abdomen relaxed, arms at sides, feet together, and weight divided equally over both legs. The tape measure was placed around the bare abdomen midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. A nonstretchable tape was evenly placed around the natural waist covering the left and right natural-waist marks. The measurement scale had to face outward, and there could not be any twists in the tape. The tape had to be just touching the skin but not compressing the soft tissue.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||cm||Standard Deviation|Mean
1232062|NCT00645099|Secondary|Change From Baseline at End Point in Body Mass Index (BMI)|BMI is calculated by dividing the body weight (in kg) by the square of height (in meters).|Baseline to End Point (up to 6 months)||||kg/m²||Standard Deviation|Mean
1232063|NCT00645099|Secondary|Change From Baseline at End Point in Body Weight|Patients were weighed lightly clothed. The same amount of clothing had to be worn each time.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||kg||Standard Deviation|Mean
1232064|NCT00645099|Secondary|Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin|As another measure of beta-cell function, the relationship between plasma insulin and glucose concentrations during the OGTT was calculated using a simplified version of the method described by Mari et al. (Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Dunning BE, Deacon CF, Holst JJ, Foley JE. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab. 2005; 90:4888-4894.).|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||pM/mM||Standard Deviation|Mean
1232065|NCT00645099|Secondary|Change From Baseline at End Point of the Insulinogenic Index|The insulinogenic index, defined as (insulin at 30 min - insulin at 0)/(glucose at 30 min [G(30)] - glucose at 0 [G(0)]) was used as a measure of early insulin secretion in response to the OGTT. Because the index is undefined when G(30)-G(0)=0, and poorly defined when G(30)-G(0)<0, the index was only calculated when G(30)>G(0).|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||pM/mM||Standard Deviation|Mean
1232066|NCT00645099|Secondary|Number of Patients With Impaired Fasting Glucose|Post-baseline glucose level under fasted conditions ≥100 mg/dL but <126 mg/dL.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||Participants|||Number
1232067|NCT00645099|Secondary|Number of Patients With Onset of Impaired Glucose Tolerance|Glucose ≥140 mg/dL, <200 mg/dL after a 75g OGTT.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||Participants|||Number
1232068|NCT00645099|Secondary|Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up|Fasting plasma glucose ≥126 mg/dL or 2-hour post-load plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) or initiated use of glucose-lowering agents during the course of the study.|6 months|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||Participants|||Number
1232069|NCT00645099|Secondary|Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is used to assess insulin resistance (IR). HOMA-IR is a dimensionless measure of insulin resistance (higher values present more insulin resistance. HOMA-IR are normalized so that lean, healthy individuals will have values of HOMA-IR close to 1.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||dimensionless||Standard Deviation|Mean
1232070|NCT00645099|Secondary|Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B)|"HOMA-%B is used to assess beta-cell function. HOMA-%B is a dimensionless measure of beta-cell function (higher values present increased insulin secretion for a given glucose level).~HOMA-%B is normalized so that lean, healthy individuals will have values of HOMA-%B close to 100%."|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post baseline data for the particular secondary efficacy parameter under discussion.|||dimensionless||Standard Deviation|Mean
1232071|NCT00645099|Secondary|Change From Baseline to End Point in Fasting Glucose||Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||mmol/L||Standard Deviation|Mean
1232072|NCT00645099|Secondary|Change From Baseline to End Point in Converted Insulin|The insulin level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||pmol/L||Standard Deviation|Mean
1232073|NCT00645099|Secondary|Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)|The level of low density lipoprotein cholesterol was calculated using the Friedwald QT formula.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||mmol/L||Standard Deviation|Mean
1232074|NCT00645099|Secondary|Change From Baseline to End Point in Total Cholesterol|The total cholesterol level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the Intent-to-Treat (ITT) analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||mmol/L||Standard Deviation|Mean
1232486|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Bacitracin|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
1232075|NCT00645099|Secondary|Change From Baseline to End Point in High Density Lipoprotein|The HDL level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||mmol/L||Standard Deviation|Mean
1232076|NCT00645099|Secondary|Change From Baseline to End Point in Triglycerides|The TG level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||mmol/L||Standard Deviation|Mean
1232077|NCT00645099|Primary|Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)|Plasma fasting TG and HDL concentrations were measured to determine the TG:HDL ratio.|Baseline to End Point (up to 6 months)|The primary end point analysis set consisted of 413 patients, i.e., all patients who received study medication at least once and had baseline and post-baseline TG and HDL data. Data of patients with missing TG or HDL values or who started or changed lipid-lowering medication during the trial were excluded from analysis.|||Ratio||Standard Deviation|Mean
1232078|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.~A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|6 Month Visit||||units on a scale||Standard Deviation|Mean
1232079|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.~A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|Post Visit||||units on a scale||Standard Deviation|Mean
1232080|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.~A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|Baseline||||units on a scale||Standard Deviation|Mean
1232081|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.~Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|6 Month Visit||||units on a scale||Standard Deviation|Mean
1232082|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.~Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|Post Visit||||units on a scale||Standard Deviation|Mean
1232083|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.~Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|Baseline||||units on a scale||Standard Deviation|Mean
1232084|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.~Severity Rating~0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.~Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|6 Month Visit||||units on a scale||Standard Deviation|Mean
1232085|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.~Severity Rating~0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.~Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|Post Visit||||units on a scale||Standard Deviation|Mean
1232112|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.|||scores on a scale||Standard Deviation|Mean
1232086|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.~Severity Rating~0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.~Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|Baseline||||units on a scale||Standard Deviation|Mean
1232087|NCT00644995|Secondary|Quit Attempt|% who made a quit attempt, defined as intentionally not smoking for at least 24 hours|6 months||||percent of participants|||Number
1232088|NCT00644995|Secondary|Number of Cigarettes Smoked Per Day|Mean change in cigarettes smoked per day from baseline|4 months||||mean change in number of cigs/day smoked||Full Range|Mean
1232089|NCT00644995|Primary|Minutes Per Week of Vigorous Physical Activity|Mean change from baseline assessed using IPAQ physical activity scale|6 months||||minutes per week||Full Range|Mean
1232090|NCT00644995|Primary|Minutes Per Week of Moderate Physical Activity|Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)|6 months||||mean change in minutes per week of PA||Full Range|Mean
1232091|NCT00644995|Primary|Days Walk Per Week|Mean change in days walk per week from baseline|6 months||||mean change in days walked per week||Full Range|Mean
1232092|NCT00644995|Primary|Abstinent From Smoking|self-reported 7 day point prevalent abstinence with non-responders coded as smokers|6 months||||percentage of participants|||Number
1232093|NCT00644995|Primary|Depression Score|% with significant change (50% reduction in SCL [Symptom Checklist] depression score)|6 months||||percentage of participants|||Number
1232094|NCT00644969|Secondary|Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day|Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.|Baseline, Week 12, Week 24|FAS; (n)=number of participants with evaluable data at observation.|||cigarettes per day||95% Confidence Interval|Least Squares Mean
1232095|NCT00644969|Secondary|Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day|Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.|Baseline, Week 12, Week 24|FAS|||participants|||Number
1232096|NCT00644969|Secondary|Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24|7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).|Week 24|FAS|||participants|||Number
1232097|NCT00644969|Secondary|Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12|7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).|Week 12|Full analysis set (FAS): all participants randomized into the study who received at least 1 dose of study treatment (formerly referred to as the All subjects analysis set).|||participants|||Number
1232098|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||participants|||Number
1232099|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 12|Safety analysis set; N=number of participants with analyzable data at observation.|||participants|||Number
1232100|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 1|Safety analysis set; N=number of participants with analyzable data at observation.|||participants|||Number
1232101|NCT00644969|Primary|Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline to Week 24|Safety analysis set; N=number of participants with evaluable data at observation.|||participants|||Number
1232102|NCT00644969|Primary|Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline (Bsl) to Week 12|Safety analysis set; N=number of participants with evaluable data at observation.|||participants|||Number
1232443|NCT00641056|Secondary|Change in Total Cholesterol From Baseline to Week 26|Change in Total Cholesterol (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
1232103|NCT00644969|Primary|"Number of Participants With Suicidal Behavior or Suicical Ideation (Yes Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Week 13 to Week 24 (Post treatment phase)|"Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. Yes response includes participants with new suicidal behavior and / or ideation."|||participants|||Number
1232104|NCT00644969|Primary|"Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Week 1 to Week 12 (Treatment phase)|"Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. Yes response includes participants with continued or new suicidal behavior and / or ideation. Treatment phase includes a 7 day lag after last dose of study treatment."|||participants|||Number
1232105|NCT00644969|Primary|Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)|10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
1232106|NCT00644969|Primary|Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)|10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.|||scores on a scale||Standard Deviation|Mean
1232107|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
1232108|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.|||scores on a scale||Standard Deviation|Mean
1232109|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
1232110|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.|||scores on a scale||Standard Deviation|Mean
1232111|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
1232644|NCT00640224|Secondary|Hs-CRP at Baseline and 6 Months|hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.|Baseline and 6 months||||mg/L||Standard Error|Mean
1232113|NCT00644969|Primary|Number of Participants With Psychiatric Adverse Events|Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.|Baseline up to Week 24|Safety analysis set; Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment). Neuropsychiatric events assessed through Week 24.|||participants|||Number
1232114|NCT00644969|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.|Baseline up to 30 days after last dose of study treatment or up to Week 16|Safety analysis set: all participants who took at least 1 dose of randomized study medication, including partial doses and had a safety measurement. Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment).|||participants|||Number
1232115|NCT00644917|Primary|Skin Reaction Score|Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.|48 hours|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
1232116|NCT00644787|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale in Double Blind Phase|The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 10|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Percentage of participants|||Number
1232117|NCT00644787|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale in Titration Phase|The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 14|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1232118|NCT00644787|Secondary|Mean Number of Rescue Doses in Double Blind Phase|Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Rescue doses||Standard Deviation|Mean
1232119|NCT00644787|Secondary|Mean Number of Rescue Doses in Titration Phase|Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Rescue doses||Standard Deviation|Mean
1232120|NCT00644787|Secondary|Number of Participants With Total Duration of Pain Per Day in Double Blind Phase|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232121|NCT00644787|Secondary|Number of Participants With Total Duration of Pain Per Day in Titration Phase|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232122|NCT00644787|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232444|NCT00641056|Secondary|Change in Body Weight (BW) From Baseline to Week 26|Change in BW (kg) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||kg||Standard Error|Least Squares Mean
1232123|NCT00644787|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232124|NCT00644787|Secondary|Percentage of Participants Achieving Pain Control in Double Blind Phase|Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain.|Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.|||Percentage of participants||95% Confidence Interval|Number
1232125|NCT00644787|Secondary|Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
1232126|NCT00644787|Secondary|Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
1232127|NCT00644787|Secondary|Number of Participants With Response Based on Participant’s Global Assessment Scale in Double Blind Phase|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232128|NCT00644787|Secondary|Number of Participants With Response Based on Participant’s Global Assessment Scale in Titration Phase|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232129|NCT00644787|Primary|Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase|The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).|Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)|Per Protocol Set (PPS) population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.|||mm||Standard Deviation|Mean
1232130|NCT00644787|Primary|Percentage of Participants Achieving Dose Titration Success|Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.|Day 14 or early discontinuation (ED)|Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1232131|NCT00644657|Secondary|The Percentage of Coated Platelets After Coronary Angiography and/or PCI|The percentage of coated platelets 24 hours after coronary angiography and/or PCI|6 hrs after procedure||||Percentage of platelets that are coated||Standard Deviation|Mean
1232132|NCT00644657|Primary|The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty|The percentage of platelets that are collagen coated after the administration of clopidogrel.|24 hours after the administration of clopidotrel||||Percent of platelets that are coated.||Standard Deviation|Mean
1232645|NCT00640224|Secondary|Leptin at Baseline and 6 Months|Leptin was measured by radioimmunoassay.|Baseline and 6 months||||ng/mL||Standard Error|Mean
1232134|NCT00644358|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a clinician-rated scale for assessing improvement of a patient’s condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse.|Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.|||score on a scale||Standard Deviation|Mean
1232135|NCT00644358|Secondary|Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score|The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.|||score on a scale||Standard Deviation|Mean
1232136|NCT00644358|Secondary|Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Participants were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.|Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.|||score on a scale||Standard Deviation|Mean
1232137|NCT00644358|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).|From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)|Safety population consisted of enrolled participants who took at least 1 dose of study drug and had at least 1 post-baseline safety measurement.|||Participants|||Number
1232138|NCT00644332|Secondary|Evaluate the Degree of Correlation Between Changes From Baseline in Items of the WISQ and SAQ With Changes From Baseline in Angina Frequency and NTG Diary Data and the DASI|The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). The planned analysis was the amount of variation in WISQ and SAQ score changes from baseline explained by changes in angina frequency, NTG use, and DASI score assessed by multiple linear regression analysis.|Baseline to Week 4|Data was collected for this outcome, however, the analysis was not done.|||coefficient of determination|||Number
1232139|NCT00644332|Primary|Evaluate the Responsiveness of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed by Regression Analysis|Responsiveness of the WISQ was assessed as the estimated coefficient of determination (R^2) of the change from baseline WISQ Total Score at 4 weeks regressed on change from baseline angina frequency and change from baseline NTG use. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set|||coefficient of determination|||Number
1232140|NCT00644332|Primary|Evaluate the Reliability of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed as Cronbach's Alpha Value|Reliability of the WISQ was assessed by estimating Cronbach's alpha (standardized); values of 0.7 or higher were to be considered adequate. (Standardized Cronbach's alpha is a coefficient of reliability or consistency, and is a function of the average inter-item correlation.) Cronbach's alpha was calculated for the WISQ instrument overall and for the Angina Frequency/Severity and Angina Stability subscales. Missing item responses were not imputed.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set|||ratio of variances|||Number
1232141|NCT00644332|Secondary|Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment|The DASI was analyzed as mean values at baseline and Week 4. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline to Week 4|Modified Intent-to-Treat Analysis Set|||DASI scale units||Standard Error|Mean
1232142|NCT00644332|Secondary|Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries|Nitroglycerin use was recorded by subjects in their diaries. Weekly frequency of NTG use was calculated for the two-week baseline period and the last two weeks of the study.|Baseline to Week 4|"Modified Intent-to-Treat Analysis Set~Missing values were excluded"|||uses per week||Standard Error|Mean
1232143|NCT00644332|Secondary|Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries|Angina episodes were recorded by subjects in their diaries. Weekly frequency of angina episodes was calculated for the two-week baseline period and the last two weeks of the study.|Baseline to Week 4|"Modified Intent-to-Treat Analysis Set~Missing values were excluded"|||attacks per week||Standard Error|Mean
1232144|NCT00644332|Primary|Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2)|Validity of the WISQ was assessed by regression analysis. Results of this analysis are reported as the estimated coefficient of determination (R^2) of the WISQ Total Score at 4 weeks regressed on 4-week angina frequency, 4-week NTG use, and DASI score at 4 weeks. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8. For mean (SEM) Baseline and Week 4 DASI values, please refer to Secondary Outcome Measure 9.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set, defined as all patients who took at least 1 dose of ranolazine and completed both baseline and postbaseline questionnaires. Partially missing questionnaire responses were imputed by the methods specified in the scoring instructions; completely missing responses were not imputed.|||coefficient of determination|||Number
1232145|NCT00644332|Secondary|Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set|||SAQ scale units||95% Confidence Interval|Number
1232146|NCT00644332|Secondary|Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set|||SAQ scale units||95% Confidence Interval|Number
1232147|NCT00644332|Secondary|Determine Whether the WISQ is Noninferior to the Seattle Angina Questionnaire (SAQ) With Regard to Angina Frequency Items Based on Changes From Baseline (BL) in the Angina Frequency Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in angina frequency items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 15 points (higher=more severe state); SAQ items: 12 points (lower=more severe state). WISQ scores were recalibrated by multiplying by .75. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set|||ratio of variance||95% Confidence Interval|Number
1232148|NCT00644280|Secondary|Significant Ocular Adverse Events|Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment|6 months||||participants|||Number
1232149|NCT00644280|Primary|Tube Success at 6 Months|Criteria for success at 6 months postoperatively was intraocular pressure (IOP) < 18mmHg without the necessity for adjunctive medication for pressure or IOP < 15mmHg with <=1 adjunctive medication.|6 months||||percentage of participants|||Number
1232150|NCT00644228|Secondary|Response Rates ()|The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted.|Up to 6 years|All eligible, analyzable patients are included.|||Participants|||Count of Participants
1232151|NCT00644228|Secondary|Overall Survival|Unstratified median overall survival in months.|Up to 6 years|All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.|||Months||95% Confidence Interval|Median
1232152|NCT00644228|Primary|Progression-free Survival|Unstratified median progression-free survival in months.|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years|All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.|||Months||95% Confidence Interval|Median
1232153|NCT00644189|Secondary|Phase I Participants: Safety|Grade 2-4 toxicities and grade 3-4 infections among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|during 6 28-day cycles and 90 days out|Phase I participants only|||Participants|||Count of Participants
1232154|NCT00644189|Secondary|All Phase I Participants: Overall Survival (OS)|Determine the overall survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|at 17 months|Phase I participants only|||percentage of participants||90% Confidence Interval|Mean
1232155|NCT00644189|Secondary|Phase I Participants: Progression-free Survival (PFS)|"Determine the progression-free survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg).~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|at 17 months|Phase I participants only|||percentage of participants||90% Confidence Interval|Mean
1232646|NCT00640224|Secondary|Adiponectin at Baseline and 6 Months|Adiponectin was measured by radioimmunoassay.|Baseline and 6 months||||ug/mL||Standard Error|Mean
1232156|NCT00644189|Secondary|Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)|"To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|Phase I participants only who were treated at the RP2D (3mg)|||Participants|||Count of Participants
1232157|NCT00644189|Secondary|All Phase I-II Participants: Safety|Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|during 6 28-day cycles and 90 days out|all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine|||Participants|||Count of Participants
1232158|NCT00644189|Secondary|All Phase I-II Participants: Overall Survival (OS)|Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|3 years|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine|||percentage of participants||95% Confidence Interval|Number
1232159|NCT00644189|Secondary|All Phase I-II Participants: Progression-free Survival (PFS)|"Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg).~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|at 1 and 2 years|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine|||percentage of patients||95% Confidence Interval|Number
1232160|NCT00644189|Secondary|Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)|"To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|only participants from phase I-II trial who were treated at the RP2D (3mg)|||percentage of participants||95% Confidence Interval|Number
1232161|NCT00644189|Primary|Phase I Participants Only: Overall Response Rate (ORR)|"Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|Phase I participants only|||percentage of participants||90% Confidence Interval|Mean
1232162|NCT00644189|Primary|All Phase I-II Participants: Overall Response Rate (ORR)|"Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine|||percentage of participants||95% Confidence Interval|Number
1232163|NCT00644059|Secondary|Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months||3 weeks after 2nd vaccination|Adequate data was not available for assessing the incidence rates of the 2009-2010 swine pandemic caused by a novel influenza A (H1N1) virus of swine origin.||||||
1232164|NCT00644059|Secondary|Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child||3 weeks after 2nd vaccination|As per an amendment to the protocol, the Secondary efficacy endpoints were evaluated in enrolled subjects only and the household members were not included in the trial for the evaluation of indirect vaccine efficacy.||||||
1232165|NCT00644059|Secondary|Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons||7 days post-vaccination|Adequate data was not available to conduct this analysis.||||||
1232166|NCT00644059|Secondary|Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)|"HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.~Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Percentage of subjects||95% Confidence Interval|Number
1232167|NCT00644059|Secondary|Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains|"Hemagglutination Inhibition (HI) assay was used for the analysis.~Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Percentage of subjects||95% Confidence Interval|Number
1232180|NCT00644059|Secondary|Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination|Number of subjects aged 6 to <36 months and in the overall age cohort (unprimed children aged 6 to <72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study|Study day 1 to Study day 181|The analysis was done on Safety set|||Number of subjects|||Number
1232168|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)|"Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.~The criteria for evaluation is GMR >2.5"|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Ratios||95% Confidence Interval|Geometric Mean
1232169|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)|Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 and GMT-TIV-adj/GMT-Non Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.|On study days 1, 29, 50 , 181|The analysis was done on Full Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
1232170|NCT00644059|Secondary|Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)|"HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.~Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Percentage of subjects||95% Confidence Interval|Number
1232171|NCT00644059|Secondary|Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)|Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Percentage of subjects||95% Confidence Interval|Number
1232172|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)|"Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points.~Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control"|On study days 1, 29, 50 and 181|The analysis was done on Full Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
1232173|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)|"The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.~The criteria for evaluation is GMR >2.5"|On study days 1, 29, 50 and 181|The analysis was done on Full Analysis Set|||Ratios||95% Confidence Interval|Geometric Mean
1232174|NCT00644059|Secondary|Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.|The number of events of Influenza like Illness reported by subjects aged 6 to <72 months was assessed for combined seasons 2007/08 and 2008/09|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set|||Events||Standard Deviation|Mean
1232175|NCT00644059|Secondary|Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set|||Days||Standard Deviation|Mean
1232176|NCT00644059|Secondary|Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set|||Number of subjects|||Number
1232177|NCT00644059|Secondary|Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to <72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set|||Number of subjects|||Number
1232178|NCT00644059|Secondary|Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).|"Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.~For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control."|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set|||Percentage of subjects|||Number
1232179|NCT00644059|Secondary|Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)|"Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.~For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control."|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set|||Percentage of subjects|||Number
1232181|NCT00644059|Secondary|Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination|Safety was assessed as the number of subjects aged 6 to <72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.|7 days post-vaccination|The analysis was done on Safety set|||Number of subjects|||Number
1232182|NCT00644059|Primary|Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)|Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to <36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set (FAS) - All subjects in the enrolled set who received study vaccination and provided at least one evaluable serum sample both before and after baseline.|||Percentage of subjects|||Number
1232183|NCT00644059|Primary|Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.|Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.|7 days post-vaccination|The analysis was done on Safety set - All subjects in the exposed population who provided post-baseline safety data.|||Number of subjects|||Number
1232184|NCT00643916|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.|Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.|Day 0 up to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated study participants, intent-to-treat population.|||Percentage of participants|||Number
1232185|NCT00643916|Primary|Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.||Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2|Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Percentage of Participants|||Number
1232186|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with BMI ≥ 27 kg/m2|||kg||Standard Error|Mean
1232187|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
1232188|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with baseline HbA1c ≥ 9%|||% of hemoglobin||Standard Error|Mean
1232189|NCT00643851|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||Percentage of participants||Standard Error|Mean
1232206|NCT00643760|Secondary|Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
1232190|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1232191|NCT00643851|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
1232192|NCT00643760|Secondary|Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data|The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
1232193|NCT00643760|Secondary|Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data|The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
1232194|NCT00643760|Secondary|Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data|The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT|ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
1232195|NCT00643760|Secondary|Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score|Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as first day of event minus last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.|Any time post-baseline until date of last dose of study medication (up to Week 13)|ITT Population|||days||Full Range|Median
1232196|NCT00643760|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data|Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||participants|||Number
1232197|NCT00643760|Secondary|Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants had a CGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||participants|||Number
1232445|NCT00641056|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
1232198|NCT00643760|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a PGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||participants|||Number
1232199|NCT00643760|Secondary|Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT|Baseline and EOMT scores are the pain scores each participant reported after taking a 50-foot walk at the randomization and Week 13/Withdrawal visits, respectively, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with BMI, baseline pain intensity after 50-foot walk, pain intensity prior to 50-foot walk at the visit being assessed, and grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a 50-foot walk at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
1232200|NCT00643760|Secondary|Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data|The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-MPQ assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
1232201|NCT00643760|Secondary|Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data|The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an NPS assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
1232202|NCT00643760|Secondary|Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||milligrams||Standard Error|Least Squares Mean
1232203|NCT00643760|Secondary|Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint.|||scores on a scale||Standard Error|Least Squares Mean
1232204|NCT00643760|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data|Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint.|||scores on a scale||Standard Error|Least Squares Mean
1232205|NCT00643760|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data|Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
1232222|NCT00643604|Secondary|Change in PAH Signs and Symptoms- Fatigue|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.|||participants|||Number
1232207|NCT00643760|Secondary|Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a current (morning) pain intensity score for the EOMT timepoint.|||scores on a scale||Standard Error|Least Squares Mean
1232208|NCT00643760|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate an average night-time pain intensity score for the EOMT timepoint.|||scores on a scale||Standard Error|Least Squares Mean
1232209|NCT00643760|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
1232210|NCT00643760|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data|Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
1232211|NCT00643682|Secondary|Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.|The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous.|2 years||||participants who had a colonoscopy|||Number
1232212|NCT00643682|Secondary|Time to Withdraw Colonoscope From Tip of Cecum to Anus.|Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy|2 years||||Time in minutes||Inter-Quartile Range|Median
1232213|NCT00643682|Secondary|Time to Advance Colonoscope From Anus to Tip of Cecum.|time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.|2 years||||time in minutes||Inter-Quartile Range|Median
1232214|NCT00643682|Primary|Boston Bowel Preparation Scale Score|An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922|2 years||||units on a scale||Inter-Quartile Range|Median
1232215|NCT00643604|Secondary|Patient Impression of Change Questionnaire|A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.|Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.|||participants|||Number
1232216|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Chest Pain|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
1232217|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Syncope|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
1232218|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Dizziness|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
1232219|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Orthopnea|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
1232220|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Dyspnea|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
1232221|NCT00643604|Secondary|Change From in Signs and Symptoms of PAH- Edema|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
1232647|NCT00640224|Secondary|Non-HDL Cholesterol at Baseline and 6 Months|Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
1232223|NCT00643604|Secondary|Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol|A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin. Drug Administration Activities Diary results are reported as average time per week spent on drug administration activities|Baseline and Week 8|"Two subjects did not have Week 8 Drug Administration Activity Diaries completed.~Connect Drug and Total Time Components: N=4; One subject did not have data recorded for Connect drug activities. Total time could not be calculated for this subject."|||minutes||Standard Deviation|Mean
1232224|NCT00643604|Secondary|Change in Score on Treatment Satisfaction Questionnaire for Medication|The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua(e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.|||units on a scale||Standard Deviation|Mean
1232225|NCT00643604|Secondary|Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and Week 8|Two subjects with a Week 8 visit outside of the visit window are included in the summary. One subject died prior to completing the Week 8 visit. One subject had an incomplete Baseline questionnaire and the CAMPHOR Activity component could not be calculated, therefore N=5 Activity and Total Score Components, and N=6 for Symptom and Quality of Life.|||units on a scale||Standard Deviation|Mean
1232226|NCT00643604|Secondary|Change in Borg Dyspnea Score Immediately After Six Minute Walk|The Borg Dyspnea Score is a 10-point scale rating the maximum level of dyspnea experienced after the Six-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.|||units on a scale||Standard Deviation|Mean
1232227|NCT00643604|Secondary|Change in WHO Functional Classification|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.|||participants|||Number
1232228|NCT00643604|Primary|Change in Six Minute Walk Distance||Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.|||meter||Standard Deviation|Mean
1232229|NCT00643578|Secondary|FEV1|The forced expiratory volume in the first second, expressed as a percent predicted.|1 hour after dose|Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.|||percent predicted||Standard Deviation|Mean
1232230|NCT00643578|Primary|Post-dose PC20|The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.|3-7 days after visits 1 and 2|Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.|||mg/mL||95% Confidence Interval|Geometric Mean
1232231|NCT00643565|Secondary|Clearance of Bevacizumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL is expressed in milliliters per day (mL/day).|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.|||mL/day||Standard Deviation|Mean
1232232|NCT00643565|Secondary|Half-Life of Bevacizumab|Half-life is the time measured for the plasma concentration to decrease by one half.|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.|||days||Standard Deviation|Mean
1232233|NCT00643565|Secondary|Volume of Distribution of Bevacizumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.|||mL||Standard Deviation|Mean
1232273|NCT00643097|Primary|Humoral and Cellular Immune Response|Number of patients that developed a delayed-type hypersensitivity (DTH) response at following vaccination. Any skin reaction in response to the intradermal injection of the antigen was measured and recorded. A positive skin test was defined as > 5 mm induration (swelling).|26 months|The test was performed on a subset of patients in each group that were available at vaccine 8, and results posted for those 30 patients who had the tests performed.|||participants|||Number
1232234|NCT00643565|Secondary|Area Under the Curve at Steady State (AUCss) of Bevacizumab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUCss is expressed in milligrams times days per milliliter (mg*day/mL).|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase|Pharmacokinetic (PK)-evaluable population included all randomized participants for whom at least one blood sample was taken for PK assessment following bevacizumab administration. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mg*day/mL||Standard Deviation|Mean
1232235|NCT00643565|Secondary|Overall Survival Duration|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Median overall survival was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.|||months||95% Confidence Interval|Median
1232236|NCT00643565|Primary|EFS Duration as Per IRC Assessment|EFS was defined as the time between randomization and occurrence of EFS event. EFS events are described in Outcome Measure 1. Median EFS was estimated using Kaplan-Meier estimates and 95% confidence intervals (CI) for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.|||months||95% Confidence Interval|Median
1232237|NCT00643565|Secondary|Percentage of Participants Who Died||Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.|||percentage of participants|||Number
1232238|NCT00643565|Secondary|Duration of Response|Duration of Response was defined as time between first objective response and the occurrence of an EFS event (described in Outcome Measure 1). Objective response was defined in Outcome Measure 3. Median duration of response was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1232239|NCT00643565|Secondary|Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response|EFS events was described in Outcome Measure 1 and Outcome Measure 3.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||percentage of participants|||Number
1232240|NCT00643565|Secondary|Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria|Objective response prior to first local therapy (surgery and/or radiotherapy) was defined as complete response (CR) or partial response (PR) determined on two consecutive occasions >/=4 weeks apart. Tumor response was assessed as per IRC using RECIST v1.0. CR was defined as disappearance of all target and non-target lesions. If immunocytology was available, no disease was to be detected by that methodology. PR was defined as at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1232241|NCT00643565|Primary|Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment|EFS events included tumor progression (IRC assessed), no evidence of response after 3 cycles of induction (derived from IRC assessment), second primary cancer, or death due to any cause. Data for participants who had not experienced an event by the time of clinical cut-off were censored at the date of the last disease assessment prior to the clinical cut-off date. Data for participants who did not have any post-baseline disease assessments were censored at the time of randomization. Tumor progression was defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.|||percentage of participants|||Number
1232242|NCT00643487|Primary|Number of Participants With Successful Recording.|Observe the behavior of the IPP of the knee by fluoroscopy. A complete recording was obtained in 2 patients: this implied that the plica,central body, and fat pad were visualized. The patients then completed a series of manouevres which demonstrated the mechanical behavior of the infrapatellar plica-fat pad complex.|During procedure, on average one hour.||||Participants|||Number
1232243|NCT00643448|Secondary|Compliance With Trans Telephonic Monitoring (TTM)|Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis|During treatment days 1-10||||Percentage of recordings analysed||Full Range|Mean
1232244|NCT00643448|Secondary|Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state|Population PK model parameter estimates derived from plasma concentrations of AZD1305|During treatment days 1-10||||μmol/L||Full Range|Mean
1232245|NCT00643448|Secondary|Adverse Events (AE)|Number of patients who had at least one AE according to the definition in the study protocol|During treatment days 2-10||||Participants|||Number
1232246|NCT00643448|Primary|Maximum QTcF|Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.|During treatment days 2-10||||ms||Full Range|Mean
1232274|NCT00643006|Primary|Change of Pain Level From Baseline.|Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.|15 weeks|Patients attending at post-test|||mm||Standard Deviation|Mean
1232275|NCT00643006|Primary|Six-minute Walk Test|Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.|15 weeks||||meter||Standard Deviation|Mean
1232247|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests|All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
1232248|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests|Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
1232249|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests|Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
1232250|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests|Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
1232251|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests|Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
1232252|NCT00643201|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants|Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued|Total number of participants receiving at least one dose of study drug. Participants were categorized according to the actual treatment received.|||participants|||Number
1232253|NCT00643201|Secondary|Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 402/2676; 676/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
1232289|NCT00642850|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP|Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1232254|NCT00643201|Secondary|Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 313/2676; 505/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
1232255|NCT00643201|Secondary|Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 103/2676; 215/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
1232256|NCT00643201|Secondary|Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants|Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 115/2676; 261/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
1232257|NCT00643201|Secondary|Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants|All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 15/2676; 49/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
1232258|NCT00643201|Secondary|Incidence of All-Cause Death During the Intended Treatment Period|Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants excluding those with missing endpoint (n/N: 41/2608; 52/2630). Events included regardless of whether or not participant received treatment, ie, ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232259|NCT00643201|Secondary|Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period|VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants in respective groups excluding those with missing endpoint information (n/N: 15/2608; 23/2630). CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232299|NCT00642759|Secondary|Overall Survival|The median overall survival in months|3 years||||Months||95% Confidence Interval|Median
1232260|NCT00643201|Secondary|Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period|VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants in respective treatment groups excluding participants with missing endpoint information. (n/N: 12/2608; 16/2630). CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232261|NCT00643201|Secondary|Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period|PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).|Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 27/2606; 25/2632). CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232262|NCT00643201|Secondary|Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period|DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 22/2608; 35/2633). CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232263|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding|VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number participants in each treatment group, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 183/2617; 333/2641). Events included as per ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232264|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 73/2610; 118/2635). Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232272|NCT00643097|Primary|Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS)|"Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.~Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator)."|58 months||||months||95% Confidence Interval|Median
1232300|NCT00642759|Secondary|6 Month Survival Rate|The percentage of participants surviving at least six months after baseline|6 months||||percentage of participants surviving||95% Confidence Interval|Number
1232648|NCT00640224|Secondary|Triglycerides at Baseline and 6 Months|Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
1232265|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|All randomized participants with non-missing secondary endpoint (n/N: 61/2609; 77/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232266|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|All randomized participants with non-missing secondary endpoint (n/N: 84/2609; 104/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232267|NCT00643201|Primary|Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment|VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).|Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)|All randomized participants with a non-missing primary endpoint (n/N: 59/2609; 71/2635, in apixaban, enoxaparin/warfarin, respectively). Intent-to-treat population. Confidence interval (CI) for event rate calculated based on the Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1232268|NCT00643123|Secondary|Hamilton Depression Scale (HAM-D)|"The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient’s level of depression before, during, and after treatment. A 28-item HAM-D form was used but only the first 17 questions are used in the assessment for depression. Of the first 17 questions, eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The sum of the scores from the first 17 questions is: 0-7 = normal, 8-13 = mild depression, 14-18 = moderate depression, 19-22=severe depression and ≥ 23=very severe depression.~Questions 18-28 are scored similarly and assess sleep disorders, paranoid behavior, motor dysfunction, psychosis, and weight gain, etc."|7 weeks||2020-02-29|02/2020||||
1232269|NCT00643123|Primary|Young Mania Rating Scale (YMRS)|"The YMRS is an 11-item, clinician-administered rating scale to assess the severity of manic symptoms before, during and after treatment. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. A score of 0 indicates the behavior is absent, whereas a score of 4 or 8 indicates the behavior is present and severe.~The change in score between Baseline and the Completion Visit will be reported. Ideally, the two time points will be Baseline and 6 Weeks after Baseline, but, if a subject terminates early, his/her last YMRS score will be carried forward to the final visit.~The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms. A score of 0-12 indicates the absence of mania or a very mild manic state, a score of 13-20 or higher indicates a mild man"|7 weeks|27 subjects were randomized but 4 (3 from the Treatment group and 1 from the Control group) withdrew from the study immediately following the baseline visit. Therefore, a second time point was unavailable for these subjects.|||units on a scale||Standard Error|Mean
1232270|NCT00643097|Secondary|Toxicity to PEP-3 Vaccine Immunization|To assess for any potential toxicity to the PEP-3 vaccine immunization in patients with newly diagnosed glioblastoma, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to tabulate any toxicities attributable to PEP-3. The number of patients with toxicity attributable to vaccine while on study are tabulated.|26 months||||participants|||Number
1232271|NCT00643097|Secondary|Response to Vaccination|The objective is to assess the duration of immunosuppressive cytokine secretion and to identify a receptive interval for active immunotherapy. Immunosuppression will determined by monitoring a panel of immunosuppressive serum/plasma cytokines longitudinally and by determining the response of each patient to Recombivax Hepatitis B (HB) vaccination. Response is defined as seropositive or seronegative to the Hepatitis B surface antigen.|26 months|This objective was not completed, as the test was not performed successfully.|||Months||Standard Deviation|Mean
1232276|NCT00642993|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at Week 12|"For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.~Per protocol, participants were either obese (BMI ≥30 kg/m^2 and ≤40 kg/m^2) or overweight (BMI ≥27 kg/m^2 and <30 kg/m^2) at enrollment."|Baeline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||kg/m^2||Standard Error|Mean
1232277|NCT00642993|Secondary|Mean Change From Baseline in Waist Circumference at Week 12|Participant's waist circumference was measured in centimeters. For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||Centimeters||Standard Error|Mean
1232278|NCT00642993|Secondary|Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12|For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||Percentage of participants|||Number
1232279|NCT00642993|Secondary|Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12|For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||Percentage of participants|||Number
1232280|NCT00642993|Primary|Mean Change From Baseline in Body Weight at Week 12|Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||Kilogram||Standard Error|Mean
1232281|NCT00642902|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.|From the first dose of study drug administration up to 12 weeks after the last dose of the study drug|Safety population included all participants who received at least 1 dose of treatment (either active or placebo).|||participants|||Number
1232282|NCT00642902|Secondary|Percentage of Participants Free From Relapses|A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature [axillary, orally, or intrauriculary] greater than (>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant’s reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.|Baseline up to Week 36|ITT population included all randomized participants.|||percentage of participants|||Number
1232283|NCT00642902|Secondary|Number of New T1 Gd-enhancing Lesions Per Participant|Analysis of new T1 Gd-enhancing lesions was done using MRI scans.|Weeks 12, 24, 36|ITT population included all randomized participants. 'n' signifies participants who were evaluable for this measure at given time points for each group, respectively.|||lesions/participant||Standard Deviation|Mean
1232284|NCT00642902|Primary|Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan|Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).|Weeks 12 to 36|ITT population included all randomized participants.|||lesions/participant/scan||95% Confidence Interval|Mean
1232285|NCT00642850|Secondary|Number of Participants With Anti-epoetin Antibody||Week -4 and at early withdrawal or Week 28|ITT Population.|||participants|||Number
1232286|NCT00642850|Secondary|Number of Participants With Red Blood Cell Transfusion During the Study|Number of participant who underwent red blood cell transfusion during the study was reported.|Week -4 up to Week 28|ITT Population.|||participants|||Number
1232287|NCT00642850|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 to Week 16 and Week 17 to Week 24|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable for specified category.|||percentage of participants|||Number
1232288|NCT00642850|Secondary|Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|ITT Population.|||days||Standard Deviation|Mean
1232290|NCT00642850|Secondary|Change in Hemoglobin Concentration Between Reference (SVP) and EEP|The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.|Week -4 up to Week -1 and Week 17 up to Week 24|The Intention-to-treat (ITT) population included all participants who had received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least 1 follow-up variable had been available.|||g/dL||Standard Deviation|Mean
1232291|NCT00642850|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range|Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|Per protocol (PP) population included all participants in the safety population with the exception of participants with less than 3 recorded hemoglobin values, missing administrations of C.E.R.A., withdrawal, inadequate iron status in Weeks 16-24.|||percentage of participants||95% Confidence Interval|Number
1232292|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|4 hrs post first dose on day 28|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percent||95% Confidence Interval|Least Squares Mean
1232293|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|Day 15, 4 hrs post switching|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percent||95% Confidence Interval|Least Squares Mean
1232294|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|4 hrs post first dose on day 28|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percent||95% Confidence Interval|Least Squares Mean
1232295|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|Day 15, 4 hrs post switching|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percent||95% Confidence Interval|Least Squares Mean
1232296|NCT00642811|Primary|Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.|The secondary definition of response to treatment is IPA >50% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|Day 14, and day 28, 4 hours post dose|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.|||Percent of participants|||Number
1232297|NCT00642811|Primary|Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.)|The primary definition of response to treatment is IPA >10% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|Day 14 and Day 28, 4 Hrs Post Dose.|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.|||Percent of Participants|||Number
1232298|NCT00642772|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.|Baseline and Following 12-Week Intervention||||units on a scale||Standard Deviation|Mean
1232302|NCT00642759|Primary|6-month Progression Free Survival Rate|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 Months||||percentage of participants||95% Confidence Interval|Number
1232303|NCT00642746|Secondary|Time to Second Progression (From Start of First-Line Regimen)|"Number of days from the initiation of first line treatment to first documented progression. Progression will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.~Progression free survival (time to progression or death, whichever occurs first) is the same as time to progression as all of the patients in this trial progressed."|Documented by Follow-up CT scans following first line treatment, average of 225 days.|95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient.|||Days||95% Confidence Interval|Median
1232304|NCT00642746|Secondary|Second-line Progression Free Survival|Time to disease progression from start of second-line experimental regimen. Disease progression will be measured per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Upon completion of follow-up, for an average of 99 days following the initiation of study treatment.|"Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.~95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient."|||Days||95% Confidence Interval|Median
1232305|NCT00642746|Primary|Response Rates of Radiographically Measurable Disease|The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.|Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.|||Number of Patients|||Number
1232306|NCT00642707|Primary|Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).|The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).|59 days|All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.|||Log10copies/HIV-1 RNA/mL||Standard Deviation|Mean
1232307|NCT00642694|Secondary|Hamilton Rating Scale for Depression 17-item||12 Weeks|||||||
1232308|NCT00642694|Secondary|Psychosocial Measures i.e. SF Health Survey, QLESQ, Social Adjustment Scale Self Report, Work and Social Adjustment Scale, Work Productivity and Activity Impairment Questionaire, and the Patients Perception of Benefits of Care.||12 Weeks|||||||
1232309|NCT00642694|Secondary|Sleep Latency|Number of minutes until fell asleep|12 weeks|Number of Participants with analyzable data for this outcome measure|||minutes||Standard Deviation|Mean
1232310|NCT00642694|Primary|Percentage of Remitters on IDS-C30 at Week 12|Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity|12 Weeks|Participants who were randomized to treatment and completed Week 12 were included in analyses|||percentage of participants|||Number
1232311|NCT00642668|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Weeks 1-40|The safety population included all participants who received at least one dose of active drug.|||percentage of participants|||Number
1232312|NCT00642668|Secondary|Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)||Weeks 29-36|ITT population included all participants who entered the titration period and received active drug.|||days||Standard Deviation|Mean
1232313|NCT00642668|Secondary|Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)||Weeks 29-36|ITT population included all participants who entered the titration period and received active drug.|||percentage of participants||95% Confidence Interval|Number
1232314|NCT00642668|Secondary|Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)|The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.|Weeks 0-36|ITT population included all participants who entered the titration period and received active drug.|||grams/deciliter (g/dL)||Standard Deviation|Mean
1232315|NCT00642668|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range|The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.|Weeks 29-36|Intent-to-Treat (ITT) population included all participants who entered the titration period and received active drug.|||percentage of participants||95% Confidence Interval|Number
1232316|NCT00642642|Secondary|Subject Live Acne Scarring Assessment Responders|Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.|Baseline (prior to first treatment) compared to one, two, and three months after last treatment|Analysis was performed on the ITT population|||Cheeks|||Number
1232317|NCT00642642|Secondary|Evaluator Live Acne Scarring Assessment Responders|Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.|Baseline (prior to first treatment) compared to one, two, and three months after last treatment|Number of cheeks for analysis was the ITT population|||Participants|||Number
1232318|NCT00642642|Primary|Subject Live Acne Scarring Assessment Responders|Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.|Baseline (prior to first treatment) and four months after last treatment|Analysis was performed on the ITT population|||Cheeks|||Number
1232319|NCT00642642|Primary|Evaluator Live Acne Scarring Assessment Responders|Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.|Baseline (prior to first treatment) and four months after last treatment|Analysis population was the ITT population, defined as subjects for whom product could be produced and who were randomized to study treatment, whether or not all study treatments are actually received.|||Participants|||Number
1232320|NCT00642616|Secondary|Change in HbA1C From Baseline to Week 52||Baseline, week 52|Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns||||||
1232321|NCT00642616|Secondary|Number of Participants With COPD Exacerbation by Treatment Arm|Number of participants who experienced worsening of COPD symptoms|Baseline to Week 52|Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying COPD|||participants|||Number
1232322|NCT00642616|Secondary|Number of Participants With Asthma Exacerbation by Treatment Arm|Number of participants who experienced worsening of asthma symptoms|Baseline to Week 52|Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying Asthma|||participants|||Number
1232323|NCT00642616|Primary|Change in Post-bronchodilator FEV1 From Baseline to Week 52|Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.|52 Weeks|Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns.||||||
1232324|NCT00642603|Primary|Progression-free Survival (PFS) in U.S. Patients Only|PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.|From first patient enrolled up to approximately 48 months|This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.||||||
1232325|NCT00642473|Primary|Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4|Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.|After 4 weeks of metronidazole treatment|All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.|||percentage of participants|||Number
1232326|NCT00642473|Primary|Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2|Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.|After 2 weeks of metronidazole treatment|All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.|||percentage of participants|||Number
1232327|NCT00642460|Secondary|Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions.|Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.|Every 2 weeks from Week 104 to 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232328|NCT00642460|Secondary|Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260|Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.|Every 2 weeks from Week 104 to 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232329|NCT00642460|Secondary|Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232330|NCT00642460|Secondary|Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232331|NCT00642460|Secondary|Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232332|NCT00642460|Secondary|Part III: Percentage of Participants in Clinical Remission|"Patients who previously withdrew are excluded Responders are patients who met all of the following criteria for inactive disease at all visits in the 6 months (180 days) prior to and including the visit assessment day: i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.~iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA. v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex.~vi. iv. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS. ESR = Erythrocyte Sedimentation Rate. VAS = Visual Analogue Scale. Data presented up to the point of entry into the Alternative Dosing Schedule."|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232333|NCT00642460|Secondary|Part III: Percentage of Participants With Inactive Disease|"Participants who previously withdrew are excluded.~Responders are participants who met all of the following criteria for inactive disease at the visit assessment day:~i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.~iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA.~v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex. vi. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS.~Data presented up to the point of entry into the Alternative Dosing Schedule."|Weeks 104, 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232334|NCT00642460|Secondary|Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits|"Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.~Baseline considered first dose of study treatment."|Every 2 weeks from Week 104 to Week 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232335|NCT00642460|Secondary|Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260|"Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.~Baseline considered first dose of study treatment. Data presented up to entry into the Alternative Dosing Schedule."|Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
1232336|NCT00642460|Secondary|Part III: Doses of Oral Corticosteroids|Oral corticosteroid values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the the visit of withdrawal and all subsequent visits.|Baseline and Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||mg/kg/day||Standard Deviation|Mean
1232337|NCT00642460|Secondary|Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week|JIA ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.|Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|The Part III ITT3 population|||percentage of participants|||Number
1232446|NCT00641056|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 26|Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline)|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > 6.5% were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
1232338|NCT00642460|Secondary|Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR|Percentage of participants with ≥30%, 50%, 70%, and 90% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.|Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|The Part III intent-to-treat (ITT3) population consists of all participants who entered into Part III of the study and received at least one administration of tocilizumab during Part III.|||percentage of participants|||Number
1232339|NCT00642460|Secondary|Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104|"Rate of SAEs, Rate of Serious Infection AEs, Rate of Related SAEs (remotely, possibly, probably) to Tocilizumab (TCZ), Rate of Macrophage Activation Syndrome, Rate of AEs leading to withdrawal and Rate of deaths per 100 patient years (PY) were calculated using the formula:~Number of Patient Events / Duration in study (years) * 100.~Multiple occurrences of the same AE in one individual are counted."|104 Weeks|Safety Population- all participants who received at least one dose of study drug and had 1 post-baseline safety assessment. Includes all safety data in the database up to the week 104 infusion based on the date of randomization for each patient. (Last date was 31 May 2011)|||Events per 100 patient year|||Number
1232340|NCT00642460|Secondary|Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104|Percentage is based on only those participants who were on oral corticosteroid at baseline and reached a nominal visit day on which dose was calculated.|Baseline, Week 104|Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.|||Percentage of Participants|||Number
1232341|NCT00642460|Secondary|Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104|"Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).~The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst)."|Baseline, Week 104|Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.|||Score on a scale||Standard Deviation|Mean
1232342|NCT00642460|Secondary|Part II: Percentage of Participants With Inactive Disease at Week 104|"Criteria for Inactive Disease:~1) No joints with active arthritis, 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal Erythrocyte Sedimentation Rate (<20 mm/hour), 4) Physician’s global assessment of disease activity Visual Analog Scale (VAS) indicates no disease activity (where no disease activity is considered to be a score ≤10 mm on a 100 mm VAS)."|Week 104|Participants from the Intent to Treat population who reached time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been nonresponders.|||Percentage of Participants|||Number
1232343|NCT00642460|Secondary|Part II: Percentage of Participants With no Active Joints at Week 104|Seventy-one joints were assessed for signs of active arthritis. The percentage of participants with no signs of active arthritis is reported.|Week 104|The Intent to Treat population in Part II includes 112 participants who received at least one dose of study drug. Only those participants who reached this time point are included in the analyses.|||Percentage of Participants|||Number
1232344|NCT00642460|Secondary|Part II: Number of Active Joints at Week 104|Seventy-one joints were assessed for signs of active arthritis. The mean number of joints with signs of active arthritis is reported.|Week 104|Participants from the Intent to Treat population who reached this time point. No data imputation is applied and patients with missing data are excluded.|||Active Joints||Standard Deviation|Mean
1232345|NCT00642460|Secondary|Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104|"The six JIA ACR components consist of: 1)Physician's global assessment of disease activity, 2)Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.~At an assessment visit a JIA ACR70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Week 104|Participants from the Intent to Treat population who reached the time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been non-responders.|||Percentage of Participants|||Number
1232346|NCT00642460|Secondary|Part I: Percentage of Patients With Anemia at Baseline With a ≥10 g/L Increase in Hemoglobin at Week 6 and Week 12|Part I: Percentage of patients who had anemia (hemoglobin <lower level normal based on sex and age) at Baseline and a ≥10 g/L increase in hemoglobin at Week 6 and at Week 12.|Baseline, Week 6 and Week 12|"Participants from the Intent-to-treat population for whom hemoglobin data available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.~LOCF rule applied to missing hemoglobin values at Week 6 and Week 12."|||Percentage of participants|||Number
1232347|NCT00642460|Secondary|Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12|Percentage of participants who had a rash characteristic of sJIA in the 14 days prior to the baseline visit but no rash characteristic of sJIA in the 14 days preceding the Week 12 visit day.|Baseline, Week 12|Participants from the Intent-to-treat population for whom data was available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.|||Percentage of participants|||Number
1232395|NCT00641719|Secondary|Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
1232348|NCT00642460|Secondary|Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12|"Percentage of patients who had at least a 0.13 improvement in CHAQ-DI score from Baseline to Week 12.~The CHAQ-DI questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do)."|Baseline, Week 12|"Intent-to-treat Population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.~LOCF rule applied to missing CHAQ-DI Scores at Week 12."|||Percentage of participants|||Number
1232349|NCT00642460|Secondary|Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12|Participants rated their pain by placing a horizontal line on a Visual Analog Scale on a scale of 0 (no pain)- 100 mm (severe pain). The score at 12 weeks minus the score at baseline. A negative number indicates improvement.|Baseline, Week 12|Participants from the Intent-to-treat population who had Pain VAS data available at baseline and week 12. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing pain VAS at Week 12.|||mm|||Number
1232350|NCT00642460|Secondary|Part I: Percentage of Participants With Concomitant Corticosteroid Reduction|"The percentage of participants receiving oral corticosteroids(CS) with a JIA ACR70 response at week 6 or Week 8 who reduced their oral CS dose by at least 20% without subsequent JIA ACR30 flare or occurrence of systemic symptoms at week 12.~At an assessment visit a JIA ACR70 response is defined as: At least three of the six JIA ACR core components improving by at least 70% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Week 6 or Week 8, Week 12|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who were taking oral corticosteroids.|||Percentage of participants|||Number
1232351|NCT00642460|Secondary|Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12|Percentage of participants with a change from an elevated hsCRP value at baseline to a normal hsCRP value at week 12; a change from anemia (low Hemoglobin) at baseline to a normal hemoglobin value at week 12; a change from thrombocytosis (elevated platelets) at baseline to a normal platelet value at week 12; a change from leukocytosis (elevated white blood cell count) at baseline to a normal white blood cell count at week 12.|Baseline, Week 12|Intent-to-treat population includes all randomized participants who received at least one dose of study drug. 'n' in each of the categories is the number of participants with data available at baseline and week 12 for analyses.|||Percentage of participants|||Number
1232352|NCT00642460|Secondary|Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12|Fever free was defined as no diary temperature recording ≥37.5° Celsius in the preceding fourteen days.|Baseline, Week 12|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who had a fever due to Systemic Juvenile Idiopathic Arthritis at baseline.|||Percentage of participants|||Number
1232353|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI)|"Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).~The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst)."|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
1232354|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate|Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured in mm/hour.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
1232355|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement|The maximum number of joints with limitation of movement is 67 and these are defined as those in the joint assessment with ‘limitation of motion’.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
1232356|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis|"The maximum number of joints with active arthritis is 71 and these are defined as those in the joint assessment with: swelling present or pain present and limitation of motion.~The joint assessment is performed by an independent assessor, who is not the treating physician, blinded to all other aspects of the patient’s efficacy and safety data."|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
1232357|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being|The Parent/Patient global assessment of overall well-being is a VAS. The scale is a 0 to 100 mm horizontal scale, the extreme left end of the line represents ‘very well’ (i.e. symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (i.e. maximum arthritis disease activity). This item is completed by the patient or parent/guardian as appropriate.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
1232649|NCT00640224|Secondary|LDL at Baseline and 6 Months|LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
1232358|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity|Physician's Global Assessment of disease activity is a Visual Analog Scale. The scale is 0 to 100 mm horizontal scale, the extreme left end of the line represents ‘arthritis inactive’ (i.e. symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. This item is completed by the treating physician.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. Last observation carried forward (LOCF) rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
1232359|NCT00642460|Secondary|Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12|"The six JIA ACR components consist of: 1) Physician's global assessment of disease activity, 2) Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.~At an assessment visit a JIA ACR30/50/70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 30%/50%/70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Week 12|Intent-to-treat population includes all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1232360|NCT00642460|Primary|Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104|Percentage of participants with ≥20 percent, ≥50 percent, ≥75 percent and ≥90 percent decreases in oral corticosteroid dose (mg/kg/day) from baseline.|Baseline, Week 104|Includes only participants on oral corticosteroids at baseline.|||Percentage of participants|||Number
1232361|NCT00642460|Primary|Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever|"Percentage of participants with ≥30% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity Visual Analog Scale (VAS), 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) consisting of 30 questions in 8 domains.~Absence of fever was defined as no diary temperature recording ≥37.5° Celsius in the preceding seven days."|Baseline, Week 12|Intent-to-treat population includes all participants who had at least one dose of study drug.|||Percentage of participants|||Number
1232362|NCT00642382|Secondary|Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject’s Global Assessment, Quality of Life and an Individual Subject Responder Analysis.||At 4, 12 and 26 weeks post 3rd injection|||||||
1232363|NCT00642382|Primary|The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain.||At 4, 12 and 26 weeks post 3rd injection|Zero patients were analyzed for this study due to the study being closed 2 months after it started. Data were not collected||||||
1232364|NCT00642369|Primary|Percentage of Rapid Eye Movement Sleep|The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF).|28 days|For the need of the statistical analysis, the study group and the control group are 30 evaluable patients respectively. Finally, in consideration of 25% un-evaluable patients after randomisation, there should be 80 patients randomised in this study with 40 patients per arm.|||percentage of rapid eye movement sleep||Standard Deviation|Mean
1232365|NCT00642369|Primary|Percentage of Slow Wave Sleep|The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).|28 days||||percentage of slow wave sleep||Standard Deviation|Mean
1232366|NCT00642356|Secondary|Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)|The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson’s disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from “not present” to “very severe”. The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline to 15 minutes prior to 2nd dose at Week 8|All subjects that were assessed for efficacy|||Units on a scale||Standard Deviation|Mean
1232367|NCT00642356|Primary|Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)|The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson’s disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from “not present” to “very severe”. The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline to 15 minutes prior to 2nd dose at Week 8|All subjects that were assessed for efficacy|||Units on a scale||Standard Deviation|Mean
1232368|NCT00642304|Secondary|Percentage of Participants With Dose Adjustment|A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.|Baseline up to Week 20|ITT population|||Percentage of participants|||Number
1232369|NCT00642304|Secondary|Percentage of Participants With Blood Transfusion||Baseline up to Week 28|ITT population|||Percentage of participants|||Number
1232370|NCT00642304|Secondary|Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP|The EEP was defined as Week 16 to Week 24.|EEP (Weeks 16 to 24)|ITT population|||Days||Standard Deviation|Mean
1232371|NCT00642304|Secondary|Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP|The EEP was defined as Week 16 to Week 24.|EEP (Weeks 16 to 24)|ITT population|||Percentage of participants||95% Confidence Interval|Number
1232372|NCT00642304|Secondary|Mean Change in Hb Concentration Between SVP and the EEP|The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.|SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)|ITT population|||g/dL||Standard Deviation|Mean
1232650|NCT00640224|Secondary|HDL at Baseline and 6 Months|HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
1232373|NCT00642304|Primary|Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)|The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.|EEP (Weeks 16 to 24)|The Intent- to -treat (ITT) population included all participants who received at least one dose of trial medication at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.|||Percentage of participants||95% Confidence Interval|Number
1232374|NCT00642278|Secondary|Percent Change in Body Weight From Baseline to Week 12|The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Deviation|Mean
1232375|NCT00642278|Secondary|Absolute Change in Body Weight From Baseline to Week 12|The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||kg||Standard Deviation|Mean
1232376|NCT00642278|Secondary|Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12|The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||mg/mg||Standard Deviation|Mean
1232377|NCT00642278|Secondary|Percentage of Patients With Symptoms of Hypoglycemia|The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.|Up to Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomiy assigned to a treatment group.|||Percentage of patients|||Number
1232378|NCT00642278|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12|The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||mmol/L||Standard Deviation|Mean
1232379|NCT00642278|Primary|Change in HbA1c From Baseline to Week 12|The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent||Standard Deviation|Mean
1232380|NCT00642174|Secondary|Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate|Thromboelastography (TEG) platelet mapping (MP) maximum amplitude (MA) – Adenosine Diphosphate (ADP) millimeters (mm) at each time point. The TEG-MP MA measures strength of clot formation in whole blood. MA-ADP is the maximal amplitude resulting from fibrin and platelets not blocked by ADP-receptor inhibiting drugs. Fibrin strands in blood sample link a rotating sample cup with a stationary pin suspended by a torsion wire. The degree of platelet contribution to the MA through platelet-fibrin bonding directly influences the magnitude of pin movement and ultimately the amplitude of the tracing.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for Inhibition of Platelet Function (IPF) as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP), who met compliance criteria, and who had last dose of study drug prior to blood draw for IPF.|||millimeters (mm)||95% Confidence Interval|Least Squares Mean
1232381|NCT00642174|Secondary|Platelet Reactivity Index (PRI)|Data from the Vasodilator-associated stimulated phosphoprotein assay were reported as the platelet reactivity index (PRI) which was calculated from corrected mean fluorescence intensity (cMFI) following incubation of platelets with either prostaglandin E1 (PGE1) alone or PGE1 plus ADP: Platelet Reactivity Index (%) = [1-(cMFI PGEI+ADP/cMFI PGEI)] x 100. Lower PRI values indicate greater platelet P2Y12 inhibition.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for Vasodilator-Associated Stimulated Phosphoprotein (VASP), who met compliance criteria, and who had last dose of study drug prior to the blood draw for inhibition of platelet function as assessed by VASP.|||percent inhibition||95% Confidence Interval|Least Squares Mean
1232382|NCT00642174|Secondary|Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA)|Mean platelet aggregation (MPA) to 5 and 20 µM adenosine diphosphate (ADP) was assessed by light transmittance aggregometry (LTA). Platelet aggregation was monitored for a total of 7 minutes after addition of ADP. Maximum platelet aggregation was the maximal aggregation value achieved during the 7-minute observation period following addition of agonists.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for MPA.|||percent platelet aggregation||95% Confidence Interval|Least Squares Mean
1232383|NCT00642174|Secondary|Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNow™ P2Y12 Assay|Inhibition of platelet aggregation 1- and 24-hours after loading dose and 24-hours after last maintenance dose was administered was assessed using Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from PRU (rate and extent of ADP-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.|1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD)|Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA.|||percent inhibition||95% Confidence Interval|Least Squares Mean
1232384|NCT00642174|Primary|Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay|The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate [ADP]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.|4 hours after loading dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA at 4 hours, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA.|||percent inhibition||95% Confidence Interval|Least Squares Mean
1232385|NCT00641862|Secondary|Childhood Neurodevelopment/Neurocognitive Function|Neurodevelopmental status and neurocognitive function are measured by measured by the cognitive scale of the Bayley scales of infant development, 3rd edition|18 and 30 months|||||||
1232386|NCT00641862|Secondary|Changes in Maternal Hemoglobin Levels, Maternal Weight Gain and Infant Birth-weight.||Maternal hemoglobin levels will be assessed at weeks 24 and 34 pre-pregnancy and at 6 weeks post-partum. Maternal weight gain will be assessed monthly until delivery and at 6 weeks post-partum. Infant birth-weight will be assessed at birth.|||||||
1232387|NCT00641862|Primary|Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester||from 1st to 3rd trimester||||pmol/L||Inter-Quartile Range|Median
1232388|NCT00641797|Primary|Likert Scale for Satisfaction|The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).|0 days||||units on a scale||Standard Deviation|Mean
1232389|NCT00641745|Primary|Number of Participants With Adverse Events.||12 months||||participants|||Number
1232390|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score|A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
1232391|NCT00641719|Secondary|Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint|A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
1232392|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores|Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
1232393|NCT00641719|Secondary|Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint|Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
1232394|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
1232440|NCT00641056|Secondary|Change in Blood Pressure From Baseline to Week 26|Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmHg||Standard Deviation|Mean
1232396|NCT00641719|Secondary|Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
1232397|NCT00641719|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
1232398|NCT00641719|Primary|Number of Participants Who Experienced an Adverse Event (AE)|See the Reported Adverse Events section for details.|baseline through 1 year|All participants who received at least 1 dose of study drug.|||participants|||Number
1232399|NCT00641706|Secondary|Proportion of Confirmed Tumor Response Defined as an Objective Status of Confirmed Response (CR), Partial Response (PR), or Regression (REGR) on Two Consecutive Evaluations|"Confidence intervals for the true proportion will be calculated using the exact binomial method.~Measurable patients must achieve at least a 50% reduction in the product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Evaluable patients must achieve unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Assessed up to 5 years|Arm A patients that started treatment. Arm B patients were not analyzed for this outcome because they received surgery and hence response was not measured.|||proportion of patients||95% Confidence Interval|Number
1232400|NCT00641706|Secondary|Time to Progression|Estimated using Kaplan-Meier survival curve. Patients who died were considered to have disease progression at the time of death unless there was documented evidence that no progression occurred before death. For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|From study registration to date of progression (up to 5 years)|Patients that started treatment.|||months||Full Range|Median
1232401|NCT00641706|Secondary|Overall Survival|Estimated using Kaplan-Meier survival curve.|From study registration to date of death due to any cause or last follow-up (up to 5 years)|Patients that started treatment.|||months||Full Range|Median
1232402|NCT00641706|Primary|Progression-free Survival at 6 Months|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|At 6 months|Patients that started treatment.|||percentage of patients|||Number
1232403|NCT00641667|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale|The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.|||Participants|||Number
1232404|NCT00641667|Secondary|Mean Number of Rescue Doses|Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Rescue Doses||Standard Deviation|Mean
1232405|NCT00641667|Secondary|Number of Participants With Total Duration of Pain Per Day|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232406|NCT00641667|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232407|NCT00641667|Secondary|Pain Intensity Visual Analog Scale (VAS) Score|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
1232408|NCT00641667|Secondary|Number of Participants With Response Based on Patient’s Global Assessment Scale|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1232409|NCT00641667|Primary|Percentage of Participants Achieving Pain Control|Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.|Day 10 or early discontinuation (ED)|Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.|||Percentage of Participants||95% Confidence Interval|Number
1232410|NCT00641641|Primary|Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)|change was calculated as the mean of 12 assessments minus the baseline value|12 times within 48 weeks.|Intention to treat|||log copies/mL plasma||Standard Deviation|Mean
1232411|NCT00641563|Secondary|BIS-Index Awake and 3 Sedation Levels (RS 2/3/4)|BIS-Index is a dimensionless value ranging from 0-100, indicating fully awake at 100 and a flat-line electroencephalogram at 0. Standard anesthesia creates a BIS-Index range 40-60. The scale is ordinal, not interval. BIS Index is calculated from the EEG by a proprietary algorithm (Aspect Medical Inc.)|awake and 3 sedation levels (RS 2/3/4) 20 min each||||Units on a scale||Standard Deviation|Mean
1232412|NCT00641563|Primary|Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels|Event Related Potentials (time-locked amplitudes in the electroencephalogram 100 milliseconds after the acoustic stimulus, averaged over 40 stimuli) Sedation levels were graded with the Ramsay scale (RS), where the responses of patients to standardized increasing stimuli (voice, then prodding, the pain stimulus) are graded. The higher the number, the deeper is the sedation. RS 6 means no response at all (= anesthesia)|awake + 3 sedation levels (RS2/3/4) (20 minutes each)||||micro Volt||Standard Deviation|Mean
1232413|NCT00641537|Primary|Number of Participants Who Developed Herpes Zoster Infections and Malignancies|Herpes zoster infection is defined as having at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms herpes zoster, herpes zoster iridocyclitis, herpes zoster ophthalmic, herpes zoster multi-dermatomal, herpes zoster infection neurological, herpes zoster oticus. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre_specified grouping Malignant and unspecified tumors.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.|||Participants|||Number
1232414|NCT00641537|Primary|Median Time to Recovery From Grade 3 or 4 Lymphocyte Toxicity|Lymphocyte toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grade for absolute lymphocyte counts included: Grade 1 = less than lower limit of normal; Grade 2 = less than 800 per cubic millimeter (/mm^3); Grade 3 = less than 500/mm^3; Grade 4 = less than 200/mm^3. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1 during the CLARITY Extension Study.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. 'N' signifies number of participants who were evaluable for this outcome measure.|||days||Full Range|Median
1232415|NCT00641537|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline up to week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.|||participants|||Number
1232416|NCT00641537|Secondary|Time to Disability Progression (Confirmed After 3 Months)|Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. As few participants have reached EDSS progression, fourth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.|Baseline up to Week 96|ITT population included all participants who were randomized in the study.|||months|||Number
1232417|NCT00641537|Secondary|Mean Number of Combined Unique (CU) Lesions|Mean Number of CU lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|ITT population included all participants who were randomized in the study.|||lesions||Standard Deviation|Mean
1232441|NCT00641056|Secondary|Ratio of Triglycerides at Week 26 to Baseline|Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||ratio||Standard Error|Least Squares Mean
1232462|NCT00640978|Primary|Number of Participants Surviving at 6 Months|Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.|6 months||||Participants|||Number
1232418|NCT00641537|Secondary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Week 96|Intention-to-treat (ITT) population included all participants who were randomized in the study.|||relapses per year||95% Confidence Interval|Number
1232419|NCT00641537|Primary|Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Lymphocyte Toxicity|Lymphocyte toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grade for absolute lymphocyte counts included: Grade 1 = less than lower limit of normal; Grade 2 = less than 800 per cubic millimeter (/mm^3); Grade 3 = less than 500/mm^3; Grade 4 = less than 200/mm^3.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.|||percentage of participants|||Number
1232420|NCT00641147|Other Pre-specified|Change in Akt Phosphorylation Levels||Baseline up to 12 months|||||||
1232421|NCT00641147|Other Pre-specified|Activation of NFKB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) Pathway||Baseline to 12 months|||||||
1232422|NCT00641147|Other Pre-specified|Change in Vascular Density||Baseline up to 12 months|||||||
1232423|NCT00641147|Other Pre-specified|Number of Patients Failing Study.|Patients withdrawn from study due to increasing polyp burden and/or advancing histology.|Up to 16 months.||||Participants|||Count of Participants
1232424|NCT00641147|Other Pre-specified|Change in Mucosal Prostaglandin Levels.||Baseline to up to 12 months.|The outcome data were not collected and the outcome will never be analyzed.||||||
1232425|NCT00641147|Other Pre-specified|Change in Mucosal Leukotriene Levels.||Baseline to up to 12 months.|The outcome data were not collected and the outcome will never be analyzed.||||||
1232426|NCT00641147|Other Pre-specified|Change in Mucosal DNA Methylation Levels.||Baseline to up to 12 months|The outcome data were not collected and the outcome will never be analyzed.||||||
1232427|NCT00641147|Secondary|Change in Apoptosis Index Levels|Change in apoptosis index levels at 8 months by assessing cleaved Caspase-3 measurement|8 months|Specimens for analysis were only available on 7 curcumin and 10 placebo participants.|||apoptotic rate||Standard Deviation|Mean
1232428|NCT00641147|Secondary|Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels|Change in cellular proliferation rate was measured by assessment of Ki-67 anti-proliferative cell nuclear antibody index levels at 8 months|Baseline up to 8 months|Specimens for analysis were only available on 7 curcumin and 10 placebo participants.|||labeled cells/crypt epithelial cells||Standard Deviation|Mean
1232429|NCT00641147|Secondary|Change in Spermine Oxidase (SMOX)|Change in SMOX mean activity level at 8 months compared to baseline (time 0)|Baseline and 8months||||pmol H2O2 per min per mg protein||Standard Deviation|Mean
1232430|NCT00641147|Secondary|Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)|Change in SSAT mean activity level at 8 months compared to baseline (time 0)|Baseline and 8 months||||pmol/acetylspermidine/mg protein/min||Standard Deviation|Mean
1232431|NCT00641147|Secondary|Change in Micro RNA 124-U6 (miR124-U6)|Change in MicroRNA mean activity level at 8 months compared to baseline (time 0)|Baseline and 8 months||||qRT-PCR relative to U6 snRNA||Standard Deviation|Mean
1232432|NCT00641147|Secondary|Change in Total Polyamines Levels|Polyamine mean level changes (expressed as pg/mg protein) at month 8-baseline|Baseline and 8 months||||pg/mg protein||Standard Deviation|Mean
1232433|NCT00641147|Secondary|Change in Ornithine Decarboxylase (ODC) Activity Levels|Change in ODC mean activity levels (expressed as nmol of activity/mg of mucosal tissue/hr) at 8 months compared to baseline (time 0)|Baseline and 8 months||||nmol/mg/hr||Standard Deviation|Mean
1232434|NCT00641147|Secondary|Medication Compliance|Medication compliance of the participant= number of capsules taken divided by the number of capsules prescribed as determined by pill count and described as a percentage per participant. Then the compliance of each participant in the assigned group (curcumin or placebo) was averaged together to obtain the medication compliance rate of that group.|Up to 12 months||||percentage of total compliance||Full Range|Median
1232435|NCT00641147|Secondary|Number of Participants With Grade >=2 Adverse Events|"Events were graded as follows:~Grade 0= no adverse event or within normal limits; Grade 1= mild adverse event (causing no limitations of usual activity); Grade 2= moderate adverse event (causing some limitation of activity); Grade 3= severe adverse event (severe and undesirable; causing inability to carry out usual activities; Grade 4= life threatening or disabling adverse event; Grade 5= fatal adverse event."|Up to 12 months||||Participants|||Count of Participants
1232436|NCT00641147|Secondary|Number of Participants With a Decrease in Polyp Burden at 12 Months|The polyp burden as evaluated by video tape review. Polyp burden at 12 months compared to time 0 for each participant and counting participants with decrease in polyp burden at 12 months.|12 months||||Participants|||Count of Participants
1232437|NCT00641147|Secondary|Mean Polyp Size in mm|Mean size of the 5 largest polyps|Up to 12 months||||mm||95% Confidence Interval|Mean
1232438|NCT00641147|Primary|Polyp Number|Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm|Up to 12 months||||polyps||95% Confidence Interval|Mean
1232439|NCT00641056|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.|Baseline to Week 26|ITT Population.|||rate per subject-year||Standard Error|Mean
1232447|NCT00641056|Secondary|Percentage of Patients Achieving HbA1c <=7.0% at Week 26|Percentage of patients achieving HbA1c <=7.0% at Week 26 (for patients with HbA1c >7% at baseline)|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > 7% were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
1232448|NCT00641056|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to Week 26|Baseline, Week 26|ITT Population: All randomized patients who had taken at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1232449|NCT00641043|Secondary|Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1232450|NCT00641043|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1232451|NCT00641043|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and Week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1232452|NCT00641043|Secondary|Percentage of Patients With HbA1c<7.0 at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1232453|NCT00641043|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and Week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1232454|NCT00641043|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetes medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1232455|NCT00641043|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1232456|NCT00641043|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1232457|NCT00641043|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1232458|NCT00641043|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1232459|NCT00641043|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1232460|NCT00641043|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1232461|NCT00641043|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1232463|NCT00640926|Other Pre-specified|Per Patient Microbiological Response of Eradicated in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)|The number of ME patients (defined as those CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila) with a microbiologic response of eradicated, i.e. either documented eradication of the baseline pathogen(s), or presumed eradication in the setting of clinical cure with no material to culture.|Study Days 14-38|Microbiologically evaluable (ME) patients were defined as CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila.|||Participants|||Number
1232464|NCT00640926|Primary|Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)|Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.|Study days 14-38|Clinically evaluable patients were those that had a diagnosis of CAP, as defined in the inclusion criteria; who received an appropriate course of therapy; who did not receive any other concomitant antibiotics, and who returned for a TOC visit in the appropriate time frame.|||Participants|||Number
1232465|NCT00640835|Primary|Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity|Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.|12 weeks|The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.|||Participants|||Number
1232466|NCT00640835|Primary|Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.|"Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:~Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs"|12 weeks|The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.|||Participants|||Number
1232467|NCT00640822|Secondary|Patients With Rebound During the Study||Week 8-16|||||||
1232468|NCT00640822|Secondary|Patients With Relapse During the Study and Time to Relapse||Week 8-16|||||||
1232469|NCT00640822|Secondary|Total Sign Score of the Intertriginous Areas||Week 8|||||||
1232470|NCT00640822|Secondary|Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment||Week 8|||||||
1232471|NCT00640822|Secondary|Severity Scores for Redness, Thickness and Scaliness of the Face||Week 8|||||||
1232472|NCT00640822|Secondary|Total Sign Score of the Face||Week 8|||||||
1232473|NCT00640822|Secondary|Overall Disease Severity of the Face According to the Investigator's Assessment||Week 4|||||||
1232474|NCT00640822|Primary|Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8||Week 8||||Participants|||Number
1232475|NCT00640653|Secondary|Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months||Measured at baseline and3, 6, 12, 18, and 24 months post-intervention|Participants with data at baseline and at least one post intervention assessment.|||Participants|||Count of Participants
1232476|NCT00640653|Secondary|Self-reported Consistent Condom Use in the Past 3 Months|Self-report of using a condom during every sexual intercourse act in the past 3 months|Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention|Participants with data at baseline and at least one post intervention assessment.|||Participants|||Count of Participants
1232477|NCT00640653|Secondary|Self-report of Having Multiple Sexual Partners in the Past 3 Months|Self-report of having sexual intercourse with more than one partner in the pat 3 months.|Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
1232478|NCT00640653|Secondary|Self-reported Sexual Intercourse in the Past 3 Months|Self-report of having sexual intercourse in the past 3 months|Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
1232479|NCT00640653|Primary|Self-report of Ever Having Sexual Intercourse|Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.|24 months post-intervention|Participants reporting never having sexual intercourse at baseline (i.e., virgins) with follow-up data on self-reported sexual intercourse during the post-intervention assessments.|||Participants|||Count of Participants
1232480|NCT00640614|Secondary|Persistent Reactions: All T.R.U.E. Test Allergens|Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)|initially occur 2-4 days after application and last through 7-21days after patch application||||participants|||Number
1232481|NCT00640614|Secondary|Late Reactions: All T.R.U.E. Test Allergens|Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).|7-10 days after patch application||||participants|||Number
1232482|NCT00640614|Secondary|Safety Evaluations: All T.R.U.E. Test Allergens|Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.|Day 2: 48 hours after application|NOTE: These secondary measurements apply to the entire subject population and were not separated by 'sensitive' or 'consecutive' subjects.|||participants|||Number
1232483|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Bronopol|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
1232484|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Disperse Blue|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
1232487|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
1232488|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
1232489|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate|Number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
1232490|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive test results to bronopol|||percentage of concordant responses||95% Confidence Interval|Number
1232491|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance:Number of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to disperse blue|||percentage of concordant responses||95% Confidence Interval|Number
1232492|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to parthenolide|||percentage of concordant responses||95% Confidence Interval|Number
1232493|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to bacitracin|||percentage of concordant responses||95% Confidence Interval|Number
1232494|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to methyldibromo-glutaronitrile|||percentage of concordant responses||95% Confidence Interval|Number
1232495|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen|Visit 5: 21 days after patch application|Subjects with past positive patch test results to hydrocortizone-17-butyrate|||percentage of concordant responses||95% Confidence Interval|Number
1232496|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen|Visit 5: 21 days after patch application|Subjects with past positive patch test results to gold sodium thiosulfate|||percentage of concordant responses||95% Confidence Interval|Number
1232497|NCT00640601|Secondary|Change in Barnes Akathisia Rating Scale (BARS)|The Percentage of patients with change in BARS score was calculated. The BARS is a 4 item scale that is rating Extrapyramidal symptoms (EPS) on a 4-point scale for the first three questions and on a 6-point scale for the last question. 0=normal and a higher value represents more pronounced symptoms of EPS. BARS has a focus on the akathisia symptoms of EPS.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||percentage of subjects|||Number
1232498|NCT00640601|Secondary|Change in Safety Measure: Simpson-Angus Scale (SAS)|The Percentage of patients with change in Simpson-Angus Scale (SAS)was calculated. This is a 10 item scale that is rated on a five-point scale where 0=normal and 4=severe symptoms of Extrapyramidal symptoms (EPS) with a focus on parkinsonian symptoms of EPS.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||Percentage of subjects|||Number
1232499|NCT00640601|Secondary|Change in Social and Occupational Functioning Assessment Scale (SOFAS)|Change in SOFAS score. The SOFAS is a 100 point single item scale that rates functioning of a patient. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
1232500|NCT00640601|Secondary|Change in Clinical Global Impression-Improvement (CGI-I) Scale|Change in CGI-I scale. This scale is the second part of the CGI scale that is scored at Visit 3 to week 24 to observe the patient’s change from start of treatment. The scores for the CGI-I subset ranges from 1 to 7 (1=very much improved, 7=very much worse and a score of 4 indicates no change.)|Day 7 - week 24|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
1232501|NCT00640601|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S assesses severity of illness which is scored to rate the patient’s current clinical state at start of treatment. The scores range from 1 to 7, where 1= normal, not at all ill, while a score of 7=among the most extremely ill of subjects. The change from start of treatment in the severity of illness is calculated by subtracting the score at start of treatment from the visit score. Alleviation of symptom severity will be indicated by a negative change score.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
1232502|NCT00640601|Secondary|Change in Global Assessment Scale (GAS)|Change in GAS score. The GAS is a 100-point single item scale that rates patient’s functioning on a hypothetical continuum of mental health to mental illness. The scale values range from 1 to 100 (1=most impaired, 100=healthiest).|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
1232503|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score|Change in negative subscale of PANSS. This subscale calculates the sum of the scores in PANSS items N1-N7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
1232504|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score|Change in positive subscale of PANSS. This subscale calculates the sum of the scores in PANSS items P1-P7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
1232505|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score|Change in PANSS total score which includes Positive, Negative and General psychopathology. The PANSS is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7, where 1=absent, 7=extreme). Maximum total score: 210, minimum total score is 30. Seven items are referring to positive symptoms (P1-7), seven items to negative symptoms (N1-7) and 16 items to general psychopathology (G1-16). The assessment prior to start of treatment is considered the baseline assessment.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
1232506|NCT00640601|Secondary|Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score|Numerical change in CGI-CB score. The CGI-CB scale is used to evaluate investigator’s global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
1232507|NCT00640601|Primary|Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study|Proportional change in CGI-CB score The CGI-CB scale is used to evaluate investigator’s global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.|Baseline to 24 weeks (or end of study)|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||Percentage of Participants||95% Confidence Interval|Mean
1232508|NCT00640562|Secondary|Concomitant Use of Antidepressive Drugs From Baseline to Week 12|Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration|Change of drug use from baseline to last visi||||Participants|||Number
1232509|NCT00640562|Secondary|Body Mass Index (BMI) at Week 12|Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment.|12 week||||Kg/m^2||Standard Deviation|Mean
1232510|NCT00640562|Secondary|Change From Screening Visit to Week 12 of Prolactin Live|Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit|12 week from screening visit to last visit||||KG||Standard Deviation|Least Squares Mean
1232511|NCT00640562|Secondary|Concomitant Use of Antidepressive Drugs From Baseline to Week 12|Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration|12 week from baseline to last visi||||Participants|||Number
1232512|NCT00640562|Secondary|Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section|"Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline.~The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40~Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments."|12 weeks from baseline to last visit||||score on scale||Standard Deviation|Mean
1232513|NCT00640562|Secondary|Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score|These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or –1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response|12 week from baseline to last visit||||score on scale||Standard Deviation|Least Squares Mean
1232514|NCT00640562|Secondary|CGI- Global Improvement Mean Score at Week 12|The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates “normal, not at all ill”, while a score of 7 indicates “among the most extremely ill of patients”. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits|12week: descriptive statistic of CGI by visit and treatment||||score on a scale||Standard Deviation|Mean
1232576|NCT00640315|Secondary|Area Under the Plasma Concentration Verse Time Curve From Zero to the Last Data Point (AUC0-tn) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
1232515|NCT00640562|Secondary|- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score|The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates “normal, not at all ill”, while a score of 7 indicates “among the most extremely ill of patients”. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits|12 weeks from baseline to last visit||||Score on scale||Standard Deviation|Least Squares Mean
1232516|NCT00640562|Secondary|Change From Baseline to Week 12 of PANSS Score|30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population.|12 weeks from baseline to last visit||||score on scale||Standard Deviation|Mean
1232517|NCT00640562|Secondary|Change From Baseline to Week 12 of HAM-D Score|21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline.|12 weeks from baseline to last visit||||Score on scale||Standard Deviation|Mean
1232518|NCT00640562|Primary|Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.|"The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms.~CDSS has 9 items rated on four–point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients’ responses to questions; the 9 item is based on clinician’s assessment.~The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression."|12 week from baseline to last visit||||Score on a scale||Standard Deviation|Least Squares Mean
1232519|NCT00640510|Secondary|Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint|The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.|30 min, 60 min, 90 min and 2 hours post first IM injection|Number of patients having the measure at post-baseline. Last Observation Carried Forward.|||participants|||Number
1232520|NCT00640510|Secondary|Number of Responders at 2 Hours After First Intramuscular (IM) Injection|A responder was defined ast he patient with ≥ 40% decrease in the PANSS-EC total score at 2 hours after the first IM injection in comparison with baseline. (See outcome measure 1 for description of PANSS-EC).|2 hours post first IM injection|Number of patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.|||participants|||Number
1232521|NCT00640510|Secondary|Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|15 min, 30 min, 60 min, 90 min post first IM injection|Number of patients having the measure both at baseline and post-baseline. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1232522|NCT00640510|Primary|Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|2 hours post first intramuscular (IM) injection|Number of randomized patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1232523|NCT00640393|Secondary|Dermatology Life Quality Index (DLQI) - PP|"The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.~Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.~Scale is from 0 best to 30 worst.~0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life"|0, 84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140. Results for one were excluded because of missing DLQI questionnaire results.|||Units on a scale||Standard Deviation|Mean
1232524|NCT00640393|Secondary|Body Surface Area (BSA) Affected by Psoriasis - PP|"BSA scores are evaluated at each time point.~BSA is a measure of the percentage of body surface affected by psoriasis."|0, 84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140.|||Percent of body affected||Standard Deviation|Mean
1232525|NCT00640393|Secondary|Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP|"Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).~PGA scores are evaluated at each time point.~The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:~0 = clear~1 = minimal~2 = mild~3 = moderate~4 = severe~5 = very severe~The scale evaluates plaque elevation, scaling and erythema."|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol. And PGA was not performed for another patient (Day 168)|||Participants|||Number
1232577|NCT00640315|Secondary|Mean Residence Time (MRT) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||hour||Geometric Coefficient of Variation|Geometric Mean
1232526|NCT00640393|Secondary|Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.|||Participants|||Number
1232527|NCT00640393|Secondary|Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.|||Participants|||Number
1232528|NCT00640393|Secondary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.|||Participants|||Number
1232529|NCT00640393|Secondary|Number of Serious Adverse Events - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of serious adverse events.~Definition: any adverse event from this study that results in one of the following outcomes, or is significant for any other reason:~death~initial or prolonged inpatient hospitalization~a life-threatening experience (that is, immediate risk of dying)~persistent or significant disability/incapacity~congenital anomaly/birth defect"|196 days|The analysis was intention to treat (ITT).|||Serious adverse events|||Number
1232530|NCT00640393|Secondary|Number of Infectious Adverse Events - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of infectious adverse events.~Definition: An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.~Only infectious and malignant (including any type of skin cancer) adverse events were recorded."|196 days|The analysis was intention to treat (ITT).|||Infectious adverse events|||Number
1232531|NCT00640393|Secondary|Number of Adverse Drug Reactions - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of adverse drug reactions.~Definition: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.~Only adverse drug reactions that were at least possibly related to etanercept were recorded. All symptoms observed at the injection site such as erythema, burning, edema and pruritus were recorded together as Injection Site Reaction."|196 days|The analysis was intention to treat (ITT).|||Adverse drug reactions.|||Number
1232532|NCT00640393|Secondary|Dermatology Life Quality Index (DLQI) - ITT|"The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.~Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.~Scale is from 0 best to 30 worst.~0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life"|0, 84, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1232533|NCT00640393|Secondary|Body Surface Area (BSA) Affected by Psoriasis - ITT|"BSA scores are evaluated at each time point.~BSA is a measure of the percentage of body surface affected by psoriasis."|0, 84, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).|||Percent of body affected||Standard Deviation|Mean
1232534|NCT00640393|Secondary|Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT|"Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).~PGA scores are evaluated at each time point.~The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:~0 = clear~1 = minimal~2 = mild~3 = moderate~4 = severe~5 = very severe~The scale evaluates plaque elevation, scaling and erythema."|0, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non Responder (NRI).|||Participants|||Number
1232535|NCT00640393|Secondary|Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
1232651|NCT00640224|Secondary|Cholesterol at Baseline and 6 Months|Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
1232536|NCT00640393|Secondary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
1232537|NCT00640393|Secondary|Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
1232538|NCT00640393|Secondary|Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
1232539|NCT00640393|Secondary|Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
1232540|NCT00640393|Secondary|Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).|||Participants|||Number
1232541|NCT00640393|Primary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112 and 140 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).|||Participants|||Number
1232542|NCT00640341|Primary|Uncorrected Distance High Contrast Visual Acuity|logMAR high contrast visual acuity (VA) over all visits.|Over all visits for the 1 month study period|All eligible dispensed eyes.|||LogMAR|Participants|Standard Deviation|Mean
1232543|NCT00640341|Primary|Subjective Responses to Comfort-related Symptoms/Complaints|Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.|Over all follow-up visits for 1 month study period|All eligible dispensed eyes.|||Units on a Scale|Participants|Standard Deviation|Mean
1232544|NCT00640341|Primary|Any Slit Lamp Finding > Grade 2|All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.|Over all follow-up visits for the 1 month study period|All dispensed eyes|||Eyes|Participants||Number
1232545|NCT00640328|Secondary|Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles)."|||hours||Geometric Coefficient of Variation|Geometric Mean
1232546|NCT00640328|Secondary|The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles)."|||liters||Geometric Coefficient of Variation|Geometric Mean
1232547|NCT00640328|Secondary|Clearance of Ofa Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
1232548|NCT00640328|Secondary|Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed for tmax.|Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||hours||Full Range|Median
1232549|NCT00640328|Secondary|The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.|Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Millgram hour per liter||Geometric Coefficient of Variation|Geometric Mean
1232550|NCT00640328|Secondary|The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).|Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||milligrams per liter||Geometric Coefficient of Variation|Geometric Mean
1232551|NCT00640328|Secondary|Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions|The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.|Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||milligrams per liter||Standard Deviation|Mean
1232552|NCT00640328|Secondary|Total Volume of T2 Lesions at Week 24 and Week 48|The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.|Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||millimeters cubed||Standard Deviation|Mean
1232553|NCT00640328|Secondary|Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)|"The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. Total T1 enhancing Ls represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage."|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||lesions||Standard Deviation|Mean
1232554|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)|Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Units per milliliter||Standard Deviation|Mean
1232555|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)|The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Degrees Celsius||Standard Deviation|Mean
1232556|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)|The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||beats per minute||Standard Deviation|Mean
1232652|NCT00640224|Secondary|Delta 17-OHPreg at Baseline and 6 Months|Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.|Baseline and 6 months||||ng/dL||Standard Error|Mean
1232557|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)|Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||millimeters of mercury||Standard Deviation|Mean
1232558|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||grams per liter||Standard Deviation|Mean
1232559|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1232560|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||millimoles per liter||Standard Deviation|Mean
1232561|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Units per liter||Standard Deviation|Mean
1232562|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||grams per liter||Standard Deviation|Mean
1232563|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Millimoles/liter||Standard Deviation|Mean
1232564|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Percentage of BV occupied by RBCs||Standard Deviation|Mean
1232578|NCT00640315|Secondary|Half-life Associated With the Terminal Slope (t1/2) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||hour||Geometric Coefficient of Variation|Geometric Mean
1232653|NCT00640224|Secondary|Delta 17-OHProg at Baseline and 6 Months|Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.|Baseline and 6 months||||ng/dL||Standard Error|Mean
1232565|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Pico (10^12) per liter||Standard Deviation|Mean
1232566|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Giga (10^9) per liter||Standard Deviation|Mean
1232567|NCT00640328|Primary|Number of Participants With Abnormal Physical Examination Findings|The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis [a brain and spinal cord disease]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|FAS|||participants|||Number
1232568|NCT00640328|Primary|Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)|Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.|Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||participants|||Number
1232569|NCT00640328|Primary|Number of Participants With the Indicated Critical Adverse Events (CAEs)|A CAE=treatment-related (TR) grade (G) >=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|FAS|||participants|||Number
1232570|NCT00640328|Primary|Number of Participants With Any Adverse Event|"An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section. Non-serious AEs were not collected during the Individualized Follow-up Period."|First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|Full Analysis Set (FAS): all participants who had been exposed to the investigational product (IP) irrespective of their compliance to the planned course of treatment.|||participants|||Number
1232571|NCT00640315|Other Pre-specified|Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Day 3|Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
1232572|NCT00640315|Other Pre-specified|Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Day 3|Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
1232573|NCT00640315|Other Pre-specified|Mean QT Duration (QTmean) - Change From Baseline to Day 3|QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
1232574|NCT00640315|Other Pre-specified|Mean QRS Duration (QRSmean) - Change From Baseline to Day 3|QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
1232575|NCT00640315|Other Pre-specified|Mean PR Duration (PRmean) - Change From Baseline to Day 3|PR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
1232654|NCT00640224|Secondary|Delta DHEA at Baseline and 6 Months|Delta DHEA was measured by HPLC-tandem mass spectroscopy.|Baseline and 6 months||||ug/dL||Standard Error|Mean
1232580|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Intrapulmonary Shunt Flow||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage of total perfusion||Standard Deviation|Mean
1232581|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Ventilation||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||L/MIN||Standard Deviation|Mean
1232582|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hours Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||L/MIN||Standard Deviation|Mean
1232583|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Normal V/Q Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232584|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Low V/Q Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232585|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Dead Space Ventilation||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage of total ventilation||Standard Deviation|Mean
1232586|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Perfusion (Q)||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||L/min||Standard Deviation|Mean
1232587|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Ventilation (V)||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||L/min||Standard Deviation|Mean
1232588|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232589|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity at the Time When the DLCO is Measured (Alveolar Volume, VA)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232590|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232591|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232592|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232593|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232594|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 25% of Expiratory Vital Capacity (MEF25)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232595|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 50% of Expiratory Vital Capacity (MEF50)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232596|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 75% of Expiratory Vital Capacity (MEF75)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232597|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232598|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232599|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC|The percent of predicted TLC was provided by investigator at site.|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232600|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232601|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232602|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232603|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232606|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Saturation (SvO2)|"Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232607|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Oxygen Saturation (SaO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232608|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Pressure (PvO2)|"Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232609|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Pressure of Carbon Dioxide (PaCO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232610|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Oxygen Pressure (PaO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
1232611|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index|Cardiac index was calculated as cardiac index = CO / body surface area.|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||L/min/m^2||Standard Deviation|Mean
1232612|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance Index (SVRI)|SVRI was calculated as SVRI = (80*(MAP - RAPmean)/CO)*body surface area|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||dyn*s*cm^-5*m^2||Standard Deviation|Mean
1232613|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance (SVR)|SVR was calculated as SVR = 80*(MAP-RAPmean)/CO|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||dyn*s*cm^-5||Standard Deviation|Mean
1232614|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance Index (PVRI)|PVRI was calculated as PVRI = (80*(PAPmean - PCWP)/CO)*body surface area|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||dyn*s*cm^-5*m^2||Standard Deviation|Mean
1232615|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)|CO was measured in triplicate by the thermodilution technique|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||L/min||Standard Deviation|Mean
1232616|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Arterial Pressure (MAP)|MAP was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
1232617|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Blood Pressure (DBP)|Diastolic arterial blood pressure was acquired during right heart catheterization.|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
1232618|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Blood Pressure (SBP)|Systolic arterial blood pressure was acquired during right heart catheterization.|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
1232619|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)|HR was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population|||beats per minute||Standard Deviation|Mean
1232620|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)|PCWP was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||mmHg||Standard Deviation|Mean
1232621|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)|PAPdiast was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
1232622|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)|PAPsyst was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||mmHg||Standard Deviation|Mean
1232623|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)|RAPmean was reported during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||mmHg||Standard Deviation|Mean
1232624|NCT00640315|Primary|Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||kg/L||Geometric Coefficient of Variation|Geometric Mean
1232625|NCT00640315|Primary|Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||10^3/L||Geometric Coefficient of Variation|Geometric Mean
1232626|NCT00640315|Primary|Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||µg/L||Geometric Coefficient of Variation|Geometric Mean
1232627|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kg Body Weight (AUCnorm) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||kg*h/L||Geometric Coefficient of Variation|Geometric Mean
1232628|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||10^3*h/L||Geometric Coefficient of Variation|Geometric Mean
1232629|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
1232630|NCT00640315|Primary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)|PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||(dyn*s*cm^-5)||Standard Deviation|Mean
1232631|NCT00640315|Primary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)|PAPmean was reported during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
1232632|NCT00640289|Secondary|Surgical Efficacy Assessments With Factor XIII|Surgical efficacy is defined as: Excellent/Good = adequate hemostasis, similar to that expected for subjects without known bleeding disorders; Fair/Poor = hemostasis less than expected; None = severe bleeding, judged due to disease despite Factor XIII (FXIII) therapy. Only the subjects who underwent a surgical procedure were counted in this outcome measure.|During surgical procedure|SP|||Surgical procedures|Surgical procedures||Count of Units
1232633|NCT00640289|Primary|Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions|Response is defined as: Excellent/Good = adequate hemostasis, similar to that expected for subjects without known bleeding disorders; Fair/Poor = hemostasis less than expected; None = severe bleeding, judged due to disease despite Factor XIII (FXIII) therapy. Only the subjects who needed additional FXIII infusions (apart from the prophylactic treatment) to control a bleed and who had investigator assessment of efficacy were counted in this outcome.|Within 12 hours of FXIII infusion|Safety Population (SP): The safety population consists of all subjects who received a dose of FXIII during the study.|||Number of bleeds|Number of bleeds||Count of Units
1232634|NCT00640250|Secondary|Adverse Events|The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.|Days 0-21||||events|||Number
1232635|NCT00640250|Secondary|Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning|"Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions.~Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application"|Day 2-21|Data from one subject not included because subject did not have past positive response to either allergen.|||percentage of participants|||Number
1232636|NCT00640250|Primary|Concordance Between Investigational Allergen and Reference Allergen|Concordance between disperse blue or bronopol and the respective reference petrolatum allergen|Visit 5: 21 days after patch application|Data from one subject not included because subject did not have past positive response to either allergen.|||percentage of agreement||95% Confidence Interval|Number
1232637|NCT00640250|Primary|Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration|Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects|Visit 4: 7 days after application|Data from one subject not included because subject did not have past positive response to either allergen.|||percentage of participants||95% Confidence Interval|Number
1232638|NCT00640250|Primary|Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration|Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects|Visit 3: 3 days after application|Data from one subject not included because subject did not have a past positive response to either allergen.|||percentage of participants||95% Confidence Interval|Number
1232639|NCT00640250|Primary|Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration|Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects|Visit 4: 7 days after application||||percentage of participants||95% Confidence Interval|Number
1232640|NCT00640250|Primary|Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration|Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects|Visit 3: 3 days after application|All subjects|||percentage of participants||95% Confidence Interval|Number
1232641|NCT00640250|Primary|Diagnostic Performance: Optimal Test Allergen Concentration|Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects|Visits 3-5: 3-21 days after application|Percentage is based on subjects sensitive to each allergen. Results from one subject not included due to no past history of positive patch test.|||percentage of participants|||Number
1232642|NCT00640224|Secondary|Night Blood Pressure at Baseline and 6 Months|Night blood pressure was measured with an automated sphygmomanometer.|Baseline and 6 months||||mm Hg||Standard Error|Mean
1232665|NCT00640042|Secondary|Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.|The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.|6 months post study|Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator.|||investigators|||Number
1232666|NCT00640042|Secondary|Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.|The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.|3 months post study|Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator.|||investigators|||Number
1232667|NCT00640042|Secondary|Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.|After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.|Up to 4 months|Number of subjects with risk level assessment at Visit 4 (Week 10)|||cases|||Number
1232668|NCT00640042|Primary|Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)|Risk level was determined by the investigator using the subject’s SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.|Visit 4 (Week 10)|Number of subjects with risk level assessment at Visit 4 (Week 10)|||participants|||Number
1232669|NCT00640042|Primary|Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)|Risk level was determined by the investigator using the subject’s SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.|Visit 3 (Week 6)|Number of subjects with risk level assessment at Visit 3 (Week 6)|||participants|||Number
1232670|NCT00640042|Primary|Number of Subjects With Treatment Emergent Adverse Events|Adverse events that occur or worsen after the first dose of Avinza|Up to 4 months||||participants|||Number
1232671|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study|Baseline (Week 0) to Visit 5 (Week 14 / End of Study)|Number of subjects with pain scores at Baseline (Week 0) and Visit 5 (Week 14 / End of Study)|||units on scale||Standard Deviation|Mean
1232672|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4|Baseline (Week 0) to Visit 4 (Week 10)|Number of subjects with pain scores at Baseline (Week 0) and Visit 4 (Week 10)|||units on scale||Standard Deviation|Mean
1232673|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3|Baseline (Week 0) to Visit 3 (Week 6)|Number of subjects with pain scores recorded at Baseline (Week 0) and Visit 3 (Week 6)|||units on scale||Standard Deviation|Mean
1232674|NCT00640016|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to 84|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1232675|NCT00640016|Secondary|Accumulation Ratio for CAT-354 (RA)|Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.|Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1232676|NCT00640016|Secondary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram*day/milliliter (mcg*day/mL)||Standard Deviation|Mean
1232677|NCT00640016|Secondary|Minimum Observed Serum Concentration (Cmin) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcg/mL||Standard Deviation|Mean
1232678|NCT00640016|Secondary|Maximum Observed Serum Concentration (Cmax) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
1232679|NCT00640016|Secondary|Adult Asthma Quality of Life (QoL) Questionnaire Final Score|The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).|Day 0, 28, 84 or early termination (any time before Day 84)|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
1232680|NCT00640016|Secondary|Morning Peak Flow and Peak Flow Variability|Peak flow is a participant’s maximum speed of expiration.|Day 0 to Day 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
1232681|NCT00640016|Secondary|Number of Participants With Exacerbations|Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).|Day 0 to Day 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
1232682|NCT00640016|Secondary|Number of Participants With Diary Data|Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.|Day 0, 4, 14, 28, 35, 56, 63 to Day and 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
1232683|NCT00640016|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.|Day 0 to 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
1232684|NCT00640016|Secondary|Asthma Control Questionnaire (ACQ) Total Score|The ACQ is questionnaire that comprises of 7-questions evaluating participant’s asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline, Day 28, 56, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||units on a scale||Standard Deviation|Mean
1232685|NCT00640016|Secondary|Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)|Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||percentage of FVC||Standard Deviation|Mean
1232738|NCT00639418|Secondary|Compliance With the Recommended Two-dose Regimen in Vaccinated Participants|Compliance was calculated from the total number of participants receiving 2 doses divided by the total number of participants identified as requiring a second dose.|Seasonal: 2007-2011||||percentage of participants|||Number
1232686|NCT00640016|Secondary|Forced Vital Capacity (FVC)|The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||liters||Standard Deviation|Mean
1232687|NCT00640016|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||liters||Standard Deviation|Mean
1232688|NCT00640016|Secondary|Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination|Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline, Day 56, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure, and 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||log2 mg/dL||Standard Deviation|Mean
1232689|NCT00640016|Primary|Change From Baseline in Doubling Concentration of Methacholine at Day 28|Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram [mg/kg]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline and Day 28|Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||log2 milligram/deciliter (mg/dL)||Standard Deviation|Mean
1232690|NCT00639860|Primary|New Bone Formation|Percentage of new bone formation of the alveolar bone core biopsies.|From Baseline to 12 weeks||||percentage of vital bone||Full Range|Mean
1232691|NCT00639860|Primary|Radiographic Bone Changes|Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).|From Baseline to 12 weeks||||percentage of bone fill||Full Range|Mean
1232692|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Stent to Apex)|Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks||||mm||Full Range|Mean
1232693|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Mesiodistal)|Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks||||mm||Full Range|Mean
1232694|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Buccopalatal)|Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks||||mm||Full Range|Mean
1232695|NCT00639769|Secondary|Number of Patients With Each Worst-grade Toxicity|Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death|6 weeks after last chemotherapy||||participants|||Number
1232696|NCT00639769|Primary|Patient Response|Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|6 weeks after last chemotherapy treatment|Analysis was per protocol (7 patients did not receive a full cycle of treatment, and 1 patient was censored for incomplete records)|||participants|||Number
1232697|NCT00639717|Secondary|Regulatory T Cell Numbers Post-transplant||180 days|T cell numbers were not analyzed||||||
1232698|NCT00639717|Secondary|Measured Level of Circulating Plasma Markers After Transplant||100 days|Plasma markers were not analyzed.||||||
1232699|NCT00639717|Secondary|The Percentage of Patients That Experienced Graft Versus Host Disease|Incidence of acute GVHD grades 2-4 and chronic GVHD in this study population|6 Months||||percentage of patients||95% Confidence Interval|Number
1232700|NCT00639717|Primary|Percentage of Patients Who Experienced Relapse by 6 Months|Relapse rate at 6 months. Relapse is defined as recurrence of disease.|6 months||||Percentage of patients||95% Confidence Interval|Number
1232701|NCT00639717|Primary|Percentage of Patients Alive at 6 Months|Overall survival at 6 months|6 months||||percentage of patients||95% Confidence Interval|Number
1232739|NCT00639418|Primary|Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices|Vaccine coverage was calculated from the number of participants vaccinated in each group, divided by the total number of participants under the practice’s care in that specific age group.|Seasonal: 2007-2011||||percentage of participants|||Number
1232702|NCT00639678|Secondary|Mean Raxibacumab Concentration-time Following Two IV Infusion Doses|Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. For the participants that received two doses, blood samples for serum raxibacumab concentration measurement were collected from participants prior to administration of the raxibacumab and diphenhydramine doses on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose.|Pre-dose on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose|Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.|||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
1232703|NCT00639678|Secondary|Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose|Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. Blood samples for serum raxibacumab concentration measurement were collected from participants who received a single-dose prior to administration of the raxibacumab and diphenhydramine doses on Day 0, at 30 minutes and 2 to 6 hours after completion of the raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose.|Pre-dose on Day 0, at 30 minutes and 2 to 6 hours after completion of raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose|Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.|||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
1232704|NCT00639678|Primary|Number of Participants Who Developed an Anti-raxibacumab Antibody Response|Number of participants who developed an anti-raxibacumab antibody response during the study were assessed. .Immunogenicity testing was performed to determine if raxibacumab induced an anti-raxibacumab immune response. Testing comprised of 2 assays (screening and confirmatory). The screening assay (direct binding) was an electrochemiluminescence (ECL)-based bridging assay. A rabbit polyclonal antibody was used as a positive control. Samples above the assay cut point were considered positive. Samples identified as positive in the screening assay were confirmed positive in a confirmatory assay. Samples must have demonstrated a significant percent drop in the confirmatory inhibition of binding assay to be considered positive. The inhibition of binding confirmatory assay was performed identically to the direct binding screening assay with the exception that the samples were tested in parallel with excess unlabeled raxibacumab.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232705|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities|Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232706|NCT00639678|Primary|Number of Participants With Urinalysis Toxicities of the Indicated Grade|Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232707|NCT00639678|Primary|Number of Participants With Thyroid Toxicities of the Indicated Grade|Clinical thyroid parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232708|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities|The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities were assessed. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232709|NCT00639678|Primary|Number of Participants With Other Chemistry Toxicities of the Indicated Grade|Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232710|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities|The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities were assessed. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232711|NCT00639678|Primary|Number of Participants With Electrolyte Toxicities of the Indicated Grade|Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232712|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities|The number of participants with at least a 2-grade worsening from Baseline in liver toxicities were assessed. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232713|NCT00639678|Primary|Number of Participants With Liver Toxicities of the Indicated Grade|Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232714|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities|The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities were assessed. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232715|NCT00639678|Primary|Number of Participants With Hematological Toxicities of the Indicated Grade|Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
1232716|NCT00639678|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population: all participants who received at least one dose of study agent, with the assignment to treatment based on the actual treatment received, unless otherwise specified|||Participants|||Number
1232717|NCT00639626|Secondary|Lean Body Mass||6 months|PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.||||||
1232718|NCT00639626|Primary|Blood Sugar||6 months|PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.||||||
1232719|NCT00639509|Secondary|Median Overall Survival|Median Overall Survival|Post-Treatment||||months||95% Confidence Interval|Median
1232720|NCT00639509|Primary|Best Overall Response Rate (ORR)|Best overall ORR will be defined as the proportion of patients achieving either confirmed partial response (PR) or confirmed complete response (CR). A Simon’s optimal two stage design will be used with the following assumption: ORR of more than 20% is acceptable and an ORR less than 5% is not acceptable.|From the start of the treatment until disease progression/recurrence||||participants|||Number
1232721|NCT00639509|Primary|PFS Rate|PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon’s optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.|At 4 months||||percentage of participants||95% Confidence Interval|Number
1232722|NCT00639457|Secondary|Myocardial Contractility-DBP|Diastolic blood pressure; vascular pressure during ventricular relaxation (diastole)|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||mmHg||Standard Error|Mean
1232723|NCT00639457|Secondary|Myocardial Contractility-SBP|Systolic blood pressure; peak vascular pressure during ventricular contraction|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||mmHg||Standard Error|Mean
1232724|NCT00639457|Secondary|Myocardial Contractility-DT|Deceleration time; time from the peak of early diastolic filling to baseline|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||msec||Standard Error|Mean
1232725|NCT00639457|Secondary|Myocardial Contractility-LV Ejection Time|Time required to empty the left ventricle into the aorta|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||msec||Standard Error|Mean
1232726|NCT00639457|Secondary|Myocardial Contractility|E/A ratio; ratio of the early (E) to late (A) ventricular filling velocities|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||ratio||Standard Error|Mean
1232727|NCT00639457|Secondary|Serum Adiponectin Levels||Baseline and week 16||||µg/mL||Standard Error|Mean
1232728|NCT00639457|Secondary|Hematocrit|Percentage of blood volume that is red cells|Baseline and Week 16||||% red cells||Standard Error|Mean
1232729|NCT00639457|Secondary|Hemoglobin||Baseline and Week 16||||g/L||Standard Error|Mean
1232730|NCT00639457|Secondary|Liver Enzyme Levels||Baseline and week 16||||U/L||Standard Error|Mean
1232731|NCT00639457|Secondary|Serum Lipid and Lipoprotein Levels||Baseline and week 16||||mM/L||Standard Error|Mean
1232732|NCT00639457|Secondary|Hepatic Glucose Production Rate|ability of insulin to suppress hepatic glucose production = hepatic insulin sensitivity|Baseline and week 16||||percent suppression||Standard Error|Mean
1232733|NCT00639457|Secondary|Hepatic Lipid Content||Baseline and week 16||||percent of water||Standard Error|Mean
1232734|NCT00639457|Secondary|Abdominal Subcutaneous Fat Volume||Baseline and week 16||||cm3||Standard Error|Mean
1232735|NCT00639457|Secondary|Visceral Fat Volume||Baseline and week 16||||cm3||Standard Error|Mean
1232736|NCT00639457|Primary|Insulin-stimulated Glucose Disposal Rate|Insulin-mediated glucose disposal rate per kg of fat free mass per min|Baseline and week16||||µmol glucose/kg FFM/min||Standard Error|Mean
1232737|NCT00639418|Secondary|Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage|Correlation of office attitudes related to influenza vaccination and actual vaccine coverage was explored. Sites were asked to indicate level of agreement with the following recommendations: vaccinating children with high-risk medical conditions, patients 6 months to 5 years of age should be vaccinated against influenza each year, patients 5 to 18 years of age without high-risk medical conditions should be vaccinated against influenza each year, and previously unvaccinated patients less than 9 years of age receive 2 doses of vaccine.|Seasonal: 2007-2011||||Sites|||Number
1232740|NCT00639379|Primary|Overall Corneal Staining|Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.|after 2 weeks use|Subjects that completed the study were analyzed.|||Units on a scale||Standard Error|Least Squares Mean
1232741|NCT00639379|Primary|Subjective Vision|A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.|1 and 2 weeks|Subjects that completed the study were analyzed.|||Units on a scale||Standard Error|Least Squares Mean
1232742|NCT00639379|Primary|Subjective Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.|1 and 2 weeks|Subjects that completed the study were analyzed.|||Units on a scale||Standard Error|Least Squares Mean
1232743|NCT00639379|Primary|Lens Stability|Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.|10-15 minutes after insertion|Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.|||Eyes|||Number
1232744|NCT00639379|Primary|Lens Orientation Within 5 Degrees|Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.|1 minute after insertion|Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.|||Eyes|||Number
1232745|NCT00639223|Secondary|Change in LDL-Cholesterol Measured at the Beginning and End of the Study||12 weeks||||Percentage Change||Standard Deviation|Mean
1232746|NCT00639223|Primary|Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500||12 weeks||||Participants|||Number
1232747|NCT00639158|Secondary|Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, last observation carried forward.|||Percent change||Inter-Quartile Range|Median
1232748|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit|[(Week 12 apoB minus baseline apoB)/baseline apoB] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoB value and at least 1 postbaseline apoB value, last observation carried forward.|||Percent change||Standard Error|Mean
1232749|NCT00639158|Secondary|Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, last observation carried forward.|||Percent change||Standard Error|Mean
1232750|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit|[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoCIII value and at least 1 postbaseline apoCIII value, last observation carried forward.|||Percent change||Standard Error|Mean
1232751|NCT00639158|Secondary|Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 weeks (final visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, last observation carried forward.|||Percent change||Standard Error|Mean
1232752|NCT00639158|Primary|Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline high density lipoprotein cholesterol (HDL-C) value and at least 1 postbaseline HDL-C value, last observation carried forward.|||Percent change||Standard Error|Mean
1232753|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit|[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoAI value and at least 1 postbaseline apoAI value, last observation carried forward.|||Percent change||Standard Error|Mean
1232754|NCT00639158|Primary|Median Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward.|||Percent change||Inter-Quartile Range|Median
1232755|NCT00639093|Secondary|Tiffany's Urge to Smoke Questionnaire||Weeks 1, 4, 6, 12, 24 and 12-month follow-up|||||||
1232756|NCT00639093|Primary|Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.|"Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample.~Six measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up)."|Weeks 1, 4, 6, 12, 24 and 12-month follow-up||||participants|||Number
1232757|NCT00639002|Secondary|Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma|"Progressive Disease requires 1 or more of the following:~Increase of ≥ 25% from baseline in:~Serum M-component and/or (increase ≥ 0.5 g/dL).~Urine M-component and/or (increase ≥ 200 mg/24 h).~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be > l0 mg/dL.~Bone marrow plasma cell percentage ≥ 10%.~Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia."|Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).|Intent-to-treat population. This outcome measure was not analyzed as no patients achieved a response.||||||
1236811|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1232758|NCT00639002|Primary|Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma|A responder is defined as a patient with a complete response (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow) or a partial response (≥ 50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥ 90% or to < 200 mg per 24 h).|Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).|Intent-to-treat population: All patients who were enrolled and took at least 1 dose of study medication.|||participants|||Number
1232759|NCT00638989|Secondary|Volume of Distribution at Steady State (Vss) After Intravenous Infusion|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution at steady state (Vss) after intravenous dosing was estimated by the formula Vss=MRT(Infinity)*CL, where MRT(Infinity)= AUCM(Infinity)/AUC(0 - infinity) where MRT(Infinity) = mean residence time at infinity, CL= clearance, AUCM[Infinity] = area under the moment curve, and AUC (0 - infinity) = area under the serum concentration versus time curve from time zero (predose) to extrapolated infinite time (0 - infinity).|Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||mL||Standard Deviation|Mean
1232760|NCT00638989|Secondary|Apparent Systemic Clearance (CL/F) After Intravenous Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||mL/day||Standard Deviation|Mean
1232761|NCT00638989|Secondary|Apparent Systemic Clearance (CL/F) After Subcutaneous Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).|Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||mL/day||Standard Deviation|Mean
1232762|NCT00638989|Secondary|Terminal Phase Elimination Half Life (t1/2)|Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||days||Standard Deviation|Mean
1232763|NCT00638989|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||days||Full Range|Median
1232764|NCT00638989|Secondary|Dose Normalized Maximum Observed Concentration (Cmax/Dose)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||(mcg/mL)/mg||Standard Deviation|Mean
1232765|NCT00638989|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
1232766|NCT00638989|Secondary|Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). (AUC [0 - infinity]) was normalized by CAT-354 dose.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||([mcg*day]/mL)/mg||Standard Deviation|Mean
1232767|NCT00638989|Secondary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||mcg*day/mL||Standard Deviation|Mean
1232768|NCT00638989|Secondary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||(microgram*day)/milliliter (mcg*day/mL)||Standard Deviation|Mean
1232769|NCT00638989|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit||Day 0 and Day 56|Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.|||participants|||Number
1232809|NCT00638690|Primary|Overall Survival|Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.|Up to 60 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
1232770|NCT00638989|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to 56|Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.|||participants|||Number
1232771|NCT00638989|Primary|Absolute Bioavailability of CAT-354 After Subcutaneous Dose|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC [0 - infinity]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|Pharmacokinetic (PK) population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate maximum observed serum concentration (Cmax).|||percent bioavailability||90% Confidence Interval|Geometric Mean
1232772|NCT00638963|Secondary|Number of Participants Who Completed the Third Cycle of Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Participants|||Number
1232773|NCT00638963|Secondary|Number of Participants Who Had at Least One Treatment Omission During Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Participants|||Number
1232774|NCT00638963|Secondary|Number of Participants Who Had at Least One Dose Reduction During Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Participants|||Number
1232775|NCT00638963|Secondary|Total Dose of Temozolomide Taken|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Milligrams||Standard Deviation|Mean
1232776|NCT00638963|Secondary|Number of Days on Temozolomide Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Days||Standard Deviation|Mean
1232777|NCT00638963|Secondary|Number of Days With Brain Recurrence-free Survival (BRFS)|"BRFS was defined as the time interval from randomization to the appearance of brain metastases.~The analysis could not be performed due to low enrollment."|24,38, and 52 weeks|||||||
1232778|NCT00638963|Secondary|Number of Days With Distant Disease-free Survival (DDFS)|"DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain).~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks|||||||
1232779|NCT00638963|Secondary|Number of Days With Disease-free Survival (DFS)|"DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant).~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks|||||||
1232780|NCT00638963|Secondary|Number of Days With Progression-free Survival (PFS)|"PFS was defined as the time interval from randomization to objective tumor progression or death from any cause.~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks|||||||
1232781|NCT00638963|Primary|Percent of Participants With Recurrence of Brain Metastases|The analysis could not be performed due to low enrollment.|1 Year|||||||
1232782|NCT00638937|Secondary|Overall Survival|"One year overall survival rate~The Kaplan-Meier method will be used."|1 year||||percentage of participants|||Number
1232783|NCT00638937|Secondary|Median Overall Survival|The Kaplan-Meier method will be used.|Up to 1 year||||months||95% Confidence Interval|Median
1232784|NCT00638937|Secondary|Progression-free Survival|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause~The Kaplan-Meier method will be used."|6 months||||months||95% Confidence Interval|Median
1232785|NCT00638937|Secondary|Median Progression-free Survival|The Kaplan-Meier method will be used.|From the date of study enrollment to the time the criteria for disease progression are met, death or last contact, or the last tumor assessment before the initiation of further anticancer therapy, assessed up to 1 year||||months||95% Confidence Interval|Median
1232786|NCT00638937|Secondary|Duration of Response or Stable Disease|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|From first response until the criteria for progression are met, assessed up to 1 year||||months||95% Confidence Interval|Median
1232787|NCT00638937|Secondary|Stable Disease Rate|"Stabilization of disease for atleast 4 cycles, leading to disease control~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|From the start of the treatment until the criteria for progression are met, assessed up to 1 year||||participants|||Number
1232788|NCT00638937|Secondary|Objective Response Rate (Complete and Partial Response)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|From the start of the treatment until the criteria for response are met||||participants|||Number
1232789|NCT00638937|Primary|Rate of Disease Control (Freedom From Disease Progression)|"Lack of disease progression, a combined rate of objective complete (disapprearance of all target lesions) and partial responses (>= 30% decrease in sum of longest diameter of target lesions) and stable disease as determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.0) for at least 4 cycles (16 weeks) of therapy.~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|112 days||||participants|||Number
1232790|NCT00638924|Primary|Shuttle Walk Test Distance|The distance achieved in the test in meters|baseline|20 to 30 years old, healthy and sedentary|||m||Standard Deviation|Mean
1232791|NCT00638924|Secondary|Heart Rate|Heart rate at baseline|baseline|20 to 30 years old, healthy and sedentary|||bpm||Standard Deviation|Mean
1232792|NCT00638885|Primary|Neuropsychological Testing of Memory|Percent retention on the Wechsler Memory Scale - Logical|2 days||||percentage of WMS retention||Standard Deviation|Mean
1232793|NCT00638846|Primary|Subjective Comfort|Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.|2 weeks of lens wear|Analysis was performed on participants who completed the study per protocol.|||units on a scale||Standard Error|Least Squares Mean
1232794|NCT00638846|Secondary|Overall Corneal Staining|National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|After 2 weeks use|Analysis was performed on participants who completed the study per protocol.|||units on a scale||Standard Error|Least Squares Mean
1232795|NCT00638846|Secondary|Subjective Lens Vision|A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.|measured at 1 and 2 weeks|Analysis was performed on participants who completed the study per protocol.|||units on a scale||Standard Error|Least Squares Mean
1232796|NCT00638846|Secondary|Time to Fit Lens|Time required for the optometrist to fit the lens.|after lens insertion|Analysis was performed on participants who completed the study per protocol.|||minutes||Standard Error|Least Squares Mean
1232797|NCT00638846|Primary|Lens Stability|Lens stability is measured as the amount of rotation induced from blink after the lens has settled.|10-15 minutes after insertion|Analysis was performed on participants who completed the study per protocol.|||proportion of eyes|Participants||Number
1232798|NCT00638846|Primary|Lens Orientation|Proportion of eyes with lens orientation within 5 degrees of optimal|1 minute after insertion|Analysis was performed on participants who completed the study per protocol. The data represents 274 eyes that wore senofilcon A lenses and 278 eyes that wore balafilcon A lenses.|||proportion of eyes|Participants||Number
1232799|NCT00638820|Secondary|Differential Imaging and Biologic Evaluations|These outcome measures were not assessed due to early study termination.|Day 100, 6 months, 1, 2 and 5 years|||||||
1232800|NCT00638820|Secondary|Number of Patients With Transplant Related Toxicity|Number of patients experiencing adverse effects due to transplant categorized by body system using Common Terminology Criteria for Adverse Events coding from the National Cancer Institute, Version 3.0.|Day 100||||Participants|||Number
1232801|NCT00638820|Secondary|Number of Patients With Transplant Related Death|Number of participants died during study by Day 100 and reason for death was related to transplant.|Day 100||||Participants|||Number
1232802|NCT00638820|Primary|Number of Patients Achieving Donor Cell Engraftment|Number of patients with persistent presence of donor-derived cells at Day 100|Day 100||||Participants|||Number
1232803|NCT00638716|Secondary|Reduction in Fasting Body Weight From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population|||kg||Standard Deviation|Mean
1232804|NCT00638716|Secondary|Reduction in FPG From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population|||mg/dL||Standard Deviation|Mean
1232805|NCT00638716|Primary|Reduction of HbA1c From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population|||Percent (%)||Standard Deviation|Mean
1232806|NCT00638690|Secondary|Radiographic Progression-free Survival|Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.|Up to 11 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
1232807|NCT00638690|Secondary|Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%|A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.|Up to 12 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.|||Participants|||Number
1232808|NCT00638690|Secondary|Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria|The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.|Up to 12 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
1232845|NCT00638404|Secondary|Anticipated Pain Medication Requirement|measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required|24 hours||||units on a scale||Full Range|Median
1232810|NCT00638651|Primary|Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream|To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone.|approximately 14 weeks||||percentage of tattoo pigment removed|Tattoo|Full Range|Mean
1232811|NCT00638508|Secondary|PATIENT SATISFACTION|"Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, 1 indicating least satisfied and 10 indication very well satisfied."|48 hours afetr surgery||||units on a scale||Standard Deviation|Mean
1232812|NCT00638508|Secondary|PATIENT SATISFACTION|"Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, 1 indicating least satisfied and 10 indication very well satisfied."|1 hour after surgery||||units on a scale||Standard Deviation|Mean
1232813|NCT00638508|Secondary|VOMITING|Data on number of episodes of vomiting was obtained, 12 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting.|12 hours||||EPISODES||Standard Deviation|Mean
1232814|NCT00638508|Secondary|VOMITING|Data on number of episodes of vomiting was obtained, 6 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting.|6 hours after surgery||||EPISODES||Standard Deviation|Mean
1232815|NCT00638508|Secondary|NAUSEA|"The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally nauseous and 10 meaning maximally nauseous."|48 hours||||units on a scale||Standard Deviation|Mean
1232816|NCT00638508|Secondary|NAUSEA|"The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally nauseous and 10 meaning maximally nauseous."|1 hour after surgery||||units on a scale||Standard Deviation|Mean
1232817|NCT00638508|Secondary|DROWSINESS|"The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally drowsy and 10 meaning maximally drowsy."|48 hours||||units on a scale||Standard Deviation|Mean
1232818|NCT00638508|Secondary|DROWSINESS|"The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally drowsy and 10 meaning maximally drowsy."|1 hour after surgery||||units on a scale||Standard Deviation|Mean
1232819|NCT00638508|Secondary|Morphine Equivalents|Utilization of morphine and morphine equivalents for rescue analgesia, was reviewed and calculated in milligrams.|48 hours afetr surgery||||milligrams||Standard Deviation|Mean
1232820|NCT00638508|Secondary|Morphine Equivalents|Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams.|12 hours after surgery||||milligrams||Standard Deviation|Mean
1232821|NCT00638508|Secondary|Morphine Equivalents Utilization|Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams.|1 hour after surgery||||miliigrams||Standard Deviation|Mean
1232822|NCT00638508|Primary|Pain on Movement|"Pain scores on movement were measured 48 hours after surgery using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|48 hours afetr surgery||||units on a scale||Standard Deviation|Mean
1232823|NCT00638508|Primary|Pain Scores on Movement|"Pain scores on movement were assessed using the Visual Analog Scale (VAS) at the end of 6 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|6 hours after surgery||||units on a scale||Standard Deviation|Mean
1232824|NCT00638508|Primary|Pain on Movement|"Pain scores on movement was assessed using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|1 hour after surgery||||units on a scale||Standard Deviation|Mean
1232825|NCT00638508|Primary|Pain Scores on Coughing|"Pain scores on coughing were measured using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|48 hours after surgery||||units on a scale||Standard Deviation|Mean
1232826|NCT00638508|Primary|Pain Scores on Coughing|"Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 6 hours after surgery. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|6 hours after surgery||||units on a scale||Standard Deviation|Mean
1232827|NCT00638508|Primary|Pain Score on Coughing|"Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|1 hour after the surgery||||units on a scale||Standard Deviation|Mean
1232828|NCT00638508|Primary|Pain Scores at Rest|"Pain scores at rest were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|48 hours after surgery||||units on a scale||Standard Deviation|Mean
1232829|NCT00638508|Primary|Pain Score at Rest|"Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|At the end of 6 hours after surgery||||units on a scale||Standard Deviation|Mean
1232830|NCT00638508|Primary|Pain Scores at Rest|"Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|1 hour after the surgery||||units on a scale||Standard Deviation|Mean
1232831|NCT00638443|Secondary|Patient Global Assessment (PGA)|Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
1236812|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1232832|NCT00638443|Secondary|Roland Morris Disability Questionnaire|The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
1232833|NCT00638443|Secondary|Modified Brief Pain Inventory (mBPI)- Interference Score|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven pain interference sub-scales. The final interference score is an average of the seven sub-scales (0 indicating no interference and 10 indicating complete interference).|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
1232834|NCT00638443|Secondary|Swiss Spinal Stenosis- Physical Function|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
1232835|NCT00638443|Secondary|Swiss Spinal Stenosis (SSS) Score- Symptom Severity|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
1232836|NCT00638443|Secondary|Oswestry Disability Index (ODI) Score|The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A total score range of 0-50; score of 0 indicates no disability and a score of 50 would indicate 100% disability.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
1232837|NCT00638443|Secondary|Visual Analog Scale (VAS)|The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
1232838|NCT00638443|Secondary|Area Under the Curve|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity multiplied by the amount of time the subject walked.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale * minutes||Standard Error|Mean
1232839|NCT00638443|Secondary|Recovery Time|After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||minutes||Standard Error|Mean
1232840|NCT00638443|Secondary|Total Distance|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||meters||Standard Error|Mean
1232841|NCT00638443|Secondary|Final Pain as Measured by NRS|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity. Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
1232842|NCT00638443|Primary|Time to First Symptoms of Moderate Pain|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.|10 days|The analyses included all enrolled randomized subjects according to the inclusion and exclusion criteria except for the three who withdrew from the trial prior to the completion of the study. One dropped out of the study due to an adverse event (dizziness).|||minutes||Standard Deviation|Mean
1232843|NCT00638404|Secondary|Anxiety|measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious|anticipated anxiety prior to surgery||||units on a scale||Standard Deviation|Mean
1232844|NCT00638404|Secondary|Anticipated Postoperative Pain at Preoperative Evaluation|anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable|anticipated postoperative pain||||units on a scale||Standard Deviation|Mean
1232846|NCT00638404|Primary|Evoked Pain at 24 Hours VAS|Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain|evoked pain at 24 hours|evoked pain outcome-measured on a scale of 0=no pain up to 100=most severe pain imaginable.|||units on a scale||Standard Deviation|Mean
1232847|NCT00638378|Secondary|Number of Participants With a Complete Response or Partial Response|Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.|From Baseline through the end of study (up to 8 months)|According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of tumor response rate was not assessed.||||||
1232848|NCT00638378|Primary|Number of Participants With Adverse Events (AE)|A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|From Baseline through to the end of study (up to 8 months)|The Safety population included all enrolled patients who received at least 1 dose of study medication.|||Participants|||Number
1232849|NCT00638378|Secondary|Time to Progression|"The time from first dosing day to the date of disease progression:~Progressive measurable disease by RECIST criteria (regardless of bone scan or prostate-specific antigen (PSA) results).~Development of unequivocal new lesions on bone scan without clinical suspicion of a “flare” reaction.~In patients who responded or had a decreased PSA from Baseline, a rise of 50% from PSA nadir, if the increase is ≥ 5 ng/mL or back to Baseline and confirmed by a 2nd value.~In patients with no decrease in PSA from Baseline, a 25% rise over Baseline and ≥ 5 ng/mL confirmed by a 2nd value."|From Baseline until the end of study (up to 8 months).|According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of median time to progression was not assessed.||||||
1232850|NCT00638378|Primary|Number of Participants With a Prostate-specific Antigen Response|A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.|Assessed monthly from Baseline until the end of study (up to 8 months)|The Intent-to-treat population, which included all patients enrolled in the study who took at least 1 dose of study medication.|||participants|||Number
1232851|NCT00638365|Primary|The Safety and Tolerability of a Single-dose of KB001.|Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.|Day 28|Safety population: all subjects randomized and receiving any study medication.|||Number of participants experiencing AEs|||Number
1232852|NCT00638274|Secondary|Number of Participants With Failed Epidural Catheters|Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery.|24 hours||||Participants|||Count of Participants
1232853|NCT00638274|Primary|Success of Spinal Labor Analgesia From Combined Spinal Epidural|Number of participants that had successful spinal labor analgesia in each group.|24 hours||||Participants|||Count of Participants
1232854|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline|||Percentage of participants||95% Confidence Interval|Number
1232855|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline|||percentage of participants||95% Confidence Interval|Number
1232856|NCT00638235|Other Pre-specified|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with uterine descent >=stage II at baseline|||Percentage of participants||95% Confidence Interval|Number
1232857|NCT00638235|Other Pre-specified|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with uterine descent >=stage II at baseline|||Percentage of participants||95% Confidence Interval|Number
1232858|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline|||percentage of participants||95% Confidence Interval|Number
1232859|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline|||percentage of participants||95% Confidence Interval|Number
1232860|NCT00638235|Primary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline|||percentage of participant||95% Confidence Interval|Number
1232861|NCT00638235|Primary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|Analysis includes only subjects with uterine descent >=stage II at baseline|||percentage of participant||95% Confidence Interval|Number
1232862|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232863|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232864|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232887|NCT00638235|Secondary|Surgical Revision Rate|The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.|Through 24 months|Percentage of total subjects experienced surgical revision (%)|||Percentage of participants|||Number
1232865|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232866|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232867|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232868|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232869|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232870|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M|Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|Changes in QoL scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||scores on a scale||Standard Deviation|Mean
1232871|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232872|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232873|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. .|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232874|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232875|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232920|NCT00637923|Secondary|Early Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.|After 12 weeks combination treatment||||participants|||Number
1232876|NCT00638235|Secondary|Wong-Baker Faces Pain Scale at 3 Months Post Procedure|Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure|baseline and 3 months|Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
1232877|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)|||Percentage of participants|||Number
1232878|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.|12 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)|||Percentage of participants|||Number
1232879|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)|||Percentage of participants|||Number
1232880|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)|||Percentage of participants|||Number
1232881|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.|12 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)|||Percentage of participants|||Number
1232882|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)|||Percentage of participants|||Number
1232883|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)|||Percentage of participants|||Number
1232884|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|12 months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)|||Percentage of participants|||Number
1232885|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months|"The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|POP-Q analysis employed last failure carried forward method, which carries subject’s objective failure at previous visits if the results are missing in the visit of interest. It’s also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.|||Percentage of participants||95% Confidence Interval|Number
1232886|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months|The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|POP-Q analysis employed last failure carried forward method, which carries subject’s objective failure at previous visits if the results are missing in the visit of interest. It’s also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.|||Percentage of participants||95% Confidence Interval|Number
1232921|NCT00637923|Secondary|End of Treatment Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.|At end of treatment||||participants|||Number
1232888|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 Months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)|||Percentage of participants|||Number
1232889|NCT00638235|Secondary|Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure|"Pain – defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating hurts worst) at baseline, and 6 weeks post procedure"|baseline and 6 weeks|Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||scores on a scale||Standard Deviation|Mean
1232890|NCT00638235|Secondary|Rates of de Novo or Worsening Urinary and/or Anal Incontinence|Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence|Through 24 months|Rate of subjects experiencing different type of incontinenece (%)|||Percentage of participants|||Number
1232891|NCT00638235|Secondary|Rate of Graft Extrusions|Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall|Through 24 months|Rate of subjects experiencing graft exposure through the vagina (%)|||Percentage of participants|||Number
1232892|NCT00638235|Secondary|Percent of Subjects Experiencing Major Device Related Complications|This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure|Through 24 months|Total subjects experienced major complications(%)|||Percentage of participants|||Number
1232893|NCT00638235|Secondary|Estimated Blood Loss|Estimated Blood Loss – defined as the estimated blood loss associated with the implantation of the study device, measured in ml|Approximately 30 minutes||||milliliters||Standard Deviation|Mean
1232894|NCT00638235|Secondary|Procedural Time|Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes|Approximately 30 minutes||||minutes||Standard Deviation|Mean
1232895|NCT00638235|Secondary|QoL Status – Defined as the Improvement in Subjects’ QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|"Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline.~Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included."|6 Months|Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.|||scores on a scale||Standard Deviation|Mean
1232896|NCT00638235|Primary|Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|"Analysis conducted only for those subjects with posterior vaginal wall prolapse >= stage II at baseline. Where a zero is indicated, no subjects meeting this criteria were enrolled."|||percentage of participant||95% Confidence Interval|Number
1232897|NCT00638222|Secondary|Plasma F2-isoprostanes||week 1, 8, 11, 18|||||||
1232898|NCT00638222|Secondary|Plasma NT-pro BNP||week 1, 8, 11, 18|||||||
1232899|NCT00638222|Secondary|Plasma Cardiac Troponin T||week 1, 8, 11, 18|||||||
1232900|NCT00638222|Secondary|Plasma C-reactive Protein||week 1, 8, 11, 18|||||||
1232901|NCT00638222|Secondary|Interleukin-6||week 1, 8, 11, 18|||||||
1232902|NCT00638222|Secondary|Oxidized LDL||week 1, 8, 11, 18|||||||
1232903|NCT00638222|Primary|Micro T- Wave Alternans||week 1, 8, 11, 18|||||||
1232904|NCT00638183|Primary|Number of Patients With Adverse Drug Reactions (ADRs)|Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.|Pre treatment and 52 weeks after the treatment|373 patients were involved in the safety analysis data|||Participants|||Number
1232905|NCT00638183|Primary|Number of Patients With Adverse Events (AEs)|Number of patients with AEs|Pre treatment and 52 weeks after the treatment|373 patients were involved in the safety analysis data|||Participants|||Number
1232906|NCT00638183|Secondary|Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks|Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation|Pre treatment and 52 weeks after the treatment|All patients for which respiratory function testing was conducted at baseline and at 52 weeks|||Liters||Standard Deviation|Mean
1232907|NCT00638183|Secondary|Effective Rate of Comprehensive Evaluation|"Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator.~Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided comprehensive evaluation.~comprehensive evaluation was classified into 3 category, improve No change+Aggravated and Unassessable by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of Improvement in total number of analyzed patients"|52 weeks|249 patient were evaluated the efficacy|||percentage of effective patients|||Number
1232922|NCT00637923|Primary|Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.|24 weeks after end of treatment||||participants|||Number
1232908|NCT00638157|Secondary|Summary of the Investigator's Assessment of Clinical Response at the TOC Visit|TOC/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. Clinical response was assessed by the investigator as cure, improvement, failure, and unable to evaluate. Microbiological response, which was determined by the sponsor based on review of baseline and post-baseline culture results, included success, failure, and nonevaluable. TC=Treatment Cure; TF=Treatment Failure; TI=Treatment Improved.|TOC Visit|Modified Intent-to-Treat (mITT) population includes all ITT patients who received at least one dose of study medication.|||Participants|||Number
1232909|NCT00638157|Primary|Summary of Clinically Significant Increases in Serum Creatinine by Visit|The End of Treatment (EOT)/Early Termination (ET) visit occurred on the day that therapy was stopped or up to 2 days after the last dose of daptomycin. The Test of Cure (TOC)/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. The overall median duration of treatment was 13.0 days in both the daptomycin group and the combination therapy group. The definition of elevated serum creatinine at baseline is >3.0 mg/dL, and not elevated is ≤3.0 mg/dL. Clinically significant increases in serum creatinine is defined as an increase ≥0.5 mg/dL for patients with a baseline value ≤3.0 mg/dL or ≥1.0 mg/dL for patients with a baseline value >3.0 mg/dL.|Baseline, EOT Visit, TOC|Safety Population includes all patients who received any dose of study medication.|||Participants|||Number
1232910|NCT00638027|Secondary|Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12|"9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity function. Timed 25-Foot Walk (T 25 FW) is a quantitative measure of lower extremity function. The patient is instructed to walk 25 feet as quickly as possible, but safely.~Paced Auditory Serial Addition Test-3 seconds (PASAT-3) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.~The MSFC is based on the concept that scores for these 3 dimensions—arm, leg, and cognitive function are combined to create a single score that can be used to detect change over time in a group of MS patients. This is done by creating Z-scores for each component of the MSFC. Implicit in this approach is the idea that patients who deteriorate or improve on all 3 component measures will have an overall larger change than patients who change on only 1 of the 3 measures. The MSFC score was transformed to z-scores, with higher scores indicating better outcome."|Baseline, Week 12|Per protocol|||Z score||Standard Deviation|Mean
1232911|NCT00638027|Secondary|Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks|"Multiple Sclerosis Spacticy Scale (MSSS-88) is a patient reported questionnaire rating scale to quantify the perspectives of the impact of spasticity on people with multiple sclerosis.~Scoring: Individual items are scored on a 4 point Likert scale: 1 (Not bothered at all), 2 (a little bothered), 3 (moderately bothered), 4 (extremely bothered).This questionnaire asks how bothered you have been by your spasticity in the past two weeks. By spasticity we mean muscle stiffness and spasms.The MSSS-88 is a reliable and valid, patient-based, interval-level measure of the impact of spasticity in multiple sclerosis. Scores were summed, without weighting or standardization, to generate ordinal-level total scores just as any other Likert-type scale. Missing responses to items can be replaced with the mean score of the items completed (person-specific item mean score) provided that 50% or more of the items in a scale have been completed. The range is 8-32 and higher scores mean poorer outcome."|baseline, 12 weeks|per protocol|||units on a scale||Standard Deviation|Mean
1232912|NCT00638027|Primary|Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks|"spasticity scale score: the most common used tool to measure the degree of spasticity of the lower extremities.~Score: Degree of Muscle Tone 0: no increase in tone~slight increase in tone 1+: slight increase in tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion.~more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved.~considerable increase in muscle tone, passive movement difficult.~affected part(s) rigid in flexion or extension."|Baseline and 12 weeks|Per Protocol|||units on a scale||Standard Deviation|Mean
1232913|NCT00638014|Secondary|Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union|The Data and Safety Monitoring Board reviewed source documents for all cases with possible sternal wound infection and sternal instability or non-union and made a determination as to the presence of these complications.|Up to 180 days||||Participants|||Number
1232914|NCT00638014|Primary|Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved|Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).|Baseline, Maximum value during postoperatively days 1 thru 7||||percentage change||Standard Deviation|Mean
1232915|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of follow up|This analysis was conducted using only data for patients that completed the baseline through the end of follow-up time points.|||participants|||Number
1232916|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of treatment|This analysis was conducted using only data for patients that completed the baseline through end of treatment time points.|||participants|||Number
1232917|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up|From baseline to week 16|This analysis was conducted using only data for patients that completed the baseline through week 16 time points.|||participants|||Number
1232918|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 8|This analysis was conducted using only data for patients that completed the baseline through week 8 time points.|||participants|||Number
1232919|NCT00637923|Secondary|Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.|After 4 weeks combination treatment||||participants|||Number
1232923|NCT00637806|Secondary|Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale|Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food|Baseline, Weeks 1, 2, 3, 4, 6 and 8|Results not analyzed due to early termination of the study||||||
1232924|NCT00637806|Secondary|Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline||Baseline, Week 4 and Week 8|Results not analyzed due to early termination of the study||||||
1232925|NCT00637806|Secondary|Change in Weight Over the Course of the 8-week Double-blind Phase||Baseline, Week 1, 2, 3, 4, 6, and 8|Results not analyzed due to early termination of the study||||||
1232926|NCT00637806|Primary|Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase|The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week’s daily caloric intake value.|8 weeks|Results not analyzed due to early termination of the study||||||
1232927|NCT00637780|Secondary|Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria|Vital sign values which met categorical summarization criteria included: supine/sitting pulse rate less than (<) 40 or more than (>) 120 beats per minute (bpm); erect pulse rate <40 or >140 bpm; changes from baseline in same posture of systolic blood pressure (SBP) more than or equal to (>=) 30 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >=20 mm Hg; SBP <90 mm Hg; and DBP <50 mm Hg.|Screening, Day 0, and Day 7|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||participants|||Number
1232928|NCT00637780|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes,clinical chemistry, and urinalysis (dipstick and microscopy).|Screening, Day 0, and Day 7|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||participants|||Number
1232929|NCT00637780|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Screening through to and including 28 calendar days after the last administration of the investigational product|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||participants|||Number
1232930|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) AUCtau at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg*hr/mL|||Number
1232931|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) Tmax at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||hr|||Number
1232932|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg/mL|||Number
1232933|NCT00637780|Primary|Sulfapyridine AUCtau at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg*hr/mL|||Number
1232934|NCT00637780|Primary|Sulfapyridine Tmax at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||hr|||Number
1232935|NCT00637780|Primary|Sulfapyridine Steady State Cmax and Cmin|Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg/mL|||Number
1232936|NCT00637780|Primary|Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg*hr/mL|||Number
1232937|NCT00637780|Primary|Sulfasalazine Time for Cmax (Tmax) at Steady State||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||hours (hr)|||Number
1232938|NCT00637780|Primary|Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||micrograms (mcg)/milliliter (mL)|||Number
1232939|NCT00637728|Secondary|Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale|Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food|Baseline, Weeks 1, 2, 3, 4, 6 and 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.||||||
1232941|NCT00637728|Secondary|Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline||Baseline, Week 4 and Week 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.||||||
1232942|NCT00637728|Primary|Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase|The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week’s daily caloric intake value.|8 weeks|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.||||||
1232943|NCT00637572|Secondary|Appetite at Baseline (Day 3) and Week 12|"Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was To what extent has your appetite changed since the start of treatment? The response was captured on a VAS scale in cm with a range from 0 ( much worse) to 10 (much better)."|Baseline (Day 3) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.|||cm||Standard Deviation|Mean
1232944|NCT00637572|Secondary|Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)|The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 [worse to better]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.|Baseline (Day 3) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.|||cm||Standard Deviation|Mean
1232945|NCT00637572|Secondary|Change in Total Energy|Food intake was quantified by the 24-hour recall food diary|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 27 subjects and 22 subjects were analyzed, respectively based on available baseline data.|||kcal||Standard Deviation|Mean
1232946|NCT00637572|Secondary|Change in Mid-arm Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit|||cm||Standard Deviation|Mean
1232947|NCT00637572|Secondary|Change in Tricep Skinfold||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit|||cm||Standard Deviation|Mean
1232948|NCT00637572|Secondary|Change in Waist Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available data measurements.|||cm||Standard Deviation|Mean
1232949|NCT00637572|Secondary|Change in Hip Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects and 29 subjects were analyzed, respectively based on available baseline measurements.|||cm||Standard Deviation|Mean
1232950|NCT00637572|Secondary|Change From Baseline in Body Fat Mass||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.|||kg||Standard Deviation|Mean
1232951|NCT00637572|Secondary|Change From Baseline in Impedance|Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.|||ohms||Standard Deviation|Mean
1232952|NCT00637572|Secondary|Change From Baseline in Lean Mass||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.|||kg||Standard Deviation|Mean
1232953|NCT00637572|Primary|Change in Body Weight|Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit|||kg||Standard Deviation|Mean
1232954|NCT00637494|Secondary|Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56|Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone|56 days||||participants|||Number
1232955|NCT00637494|Primary|Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56|Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone|56 days||||participants|||Number
1232957|NCT00637377|Secondary|Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 – LOCF|CNV area values measured in square millimeters; lower values represent better outcomes.|Baseline and at week 52|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||mm^2||Standard Deviation|Mean
1232958|NCT00637377|Secondary|Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 – LOCF|The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).|Baseline and at week 52|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||Scores on a scale||Standard Deviation|Mean
1232959|NCT00637377|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 – LOCF|"Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.~Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed."|At week 52|Full-Analysis Set; imputation technique: LOCF|||Percentage of participants|||Number
1232960|NCT00637377|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 – LOCF|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|Full-Analysis Set (FAS); imputation technique: LOCF|||Letters correctly read||Standard Deviation|Mean
1232961|NCT00637377|Primary|Percentage of Participants Who Maintained Vision at Week 52 – Last Observation Carried Forward (LOCF)|"Maintenance of vision was defined as a loss of < 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.~Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed."|At week 52|Per-Protocol Set (PPS); imputation technique: LOCF|||Percentage of participants|||Number
1232962|NCT00637312|Primary|Evaluation of Device and/or Procedure Related Adverse Event(s)||At 24-months|The study was suspended for higher than anticipated adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent treatment group. Agency approval is not being pursued for this device and thus no analysis has been completed.||||||
1232963|NCT00637299|Secondary|Lung Function Test|residual volume (RV)|4 weeks||||liters||Standard Deviation|Mean
1232964|NCT00637299|Primary|Walking Ability|6 minutes walking test (6MWT)|4 weeks||||meters||Standard Deviation|Mean
1232965|NCT00637273|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 26|ITT Population.|||rate per subject-year||Standard Error|Mean
1232966|NCT00637273|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||ratio||Standard Error|Least Squares Mean
1232967|NCT00637273|Secondary|Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26|Change in fasting HDL from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1232968|NCT00637273|Secondary|Change in Fasting Total Cholesterol From Baseline to Week 26|Change in fasting total cholesterol from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1232969|NCT00637273|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26|Change in diastolic blood pressure from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mmHg||Standard Error|Least Squares Mean
1232970|NCT00637273|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26|Change in systolic blood pressure from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mmHg||Standard Error|Least Squares Mean
1232971|NCT00637273|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 26|Change in fasting plasma glucose from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1232972|NCT00637273|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||kg||Standard Error|Least Squares Mean
1232973|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26|Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1232974|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1232975|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <7% at Week 26|Percentages of subjects achieving HbA1c target values of <7% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1232976|NCT00637273|Primary|Change in HbA1c From Baseline to Week 26|Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].|Day 1, Week 26|The ITT Population included randomized subjects who received at least one injection of study medication. Missing data up to Week 26 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1232977|NCT00637247|Secondary|To Evaluate the OS, ORR, PFS, 1-year Survival, and Changes in CA19.9 of Subjects on the Two Treatment Arms That Completed > 1 Cycle (28 Days) of Protocol Treatment||one year|||||||
1232978|NCT00637247|Secondary|To Evaluate the Changes in Blood Levels of CA19.9 on the Two Treatment Arms and Whether There is a Relationship to Objective Response, and PFS||one year|||||||
1232979|NCT00637247|Secondary|One Year Survival|To evaluate the 1-year survival rates of the two treatment arms.|one year|||||||
1232980|NCT00637247|Secondary|Progression Free Survival|To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.|one year|Intention to treat|||months|progression free survival|95% Confidence Interval|Median
1232981|NCT00637247|Secondary|Objective Response Rates of the Two Treatment Arms|Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.|one year|Per protocol, response evaluable population was treated and had baseline and at least one response evaluation.|||percent of responses|||Number
1232982|NCT00637247|Primary|To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms||up to 2 years|||||||
1232983|NCT00637247|Primary|Overall Survival for the Intent to Treat Population|To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.|up to 2 years|Intention to treat with subjects who were alive at the time of the survival analysis or lost to follow-up were considered censored at the last date the subject was known to be alive.|||months||95% Confidence Interval|Median
1232984|NCT00637195|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to study end (Month 13)|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1232985|NCT00637195|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to study end (Month 13)|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1232986|NCT00637195|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1232987|NCT00637195|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1232988|NCT00637195|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.~Data are presented across doses."|During the 7-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1232989|NCT00637195|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.~Data are presented across doses."|During the 7-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1232990|NCT00637195|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include injection site pain, redness and swelling.~Data are presented across doses."|During the 7-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1232991|NCT00637195|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include injection site pain, redness and swelling.~Data are presented across doses."|During the 7-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1232992|NCT00637195|Secondary|Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course|Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.|At Months 2 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1232993|NCT00637195|Secondary|Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course|A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.|Months 2 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.|||Participants|||Count of Participants
1232994|NCT00637195|Secondary|Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies|Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.|Months 2, 3 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.|||Participants|||Count of Participants
1232995|NCT00637195|Secondary|Anti-HPV-16/18 Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|Months 2 and 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine with available data.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1232996|NCT00637195|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination.~Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|Months 2 and 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine and with available data.|||Participants|||Count of Participants
1232997|NCT00637195|Primary|Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix|Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).|Month 3|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1232998|NCT00637195|Primary|Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix|A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).|Month 3|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination .|||Participants|||Count of Participants
1232999|NCT00637156|Secondary|Change of General Health Status -- SF-36 MCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
1233000|NCT00637156|Secondary|Change of General Health Status -- SF-36 PCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
1233001|NCT00637156|Secondary|Change of Arm Pain Score From Baseline|"Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline."|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
1233002|NCT00637156|Secondary|Change of Neck Pain Score From Baseline|"Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline."|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
1233003|NCT00637156|Secondary|Change of Neck Disability Index Score From Baseline|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
1233004|NCT00637156|Secondary|Rate of Secondary Surgery at Index Level|Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.|24 months||||percentage of participants|||Number
1233005|NCT00637156|Secondary|Hospital Stay||From admission to discharge, an average of 1.0-1.5 day||||days||Standard Deviation|Mean
1233006|NCT00637156|Secondary|Blood Loss||During the time of operation, an average of 1.7-2.1 hrs||||ml||Standard Deviation|Mean
1233007|NCT00637156|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, an average of 1.7-2.1hrs||||hrs||Standard Deviation|Mean
1233008|NCT00637156|Secondary|Gait Success Rate|Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
1233009|NCT00637156|Secondary|Rate of Disc Height Success|Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 170 subjects in the investigational group and 138 subjects in the control group.|||percentage of participants|||Number
1233010|NCT00637156|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.|||percentage of participants|||Number
1233011|NCT00637156|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.|||percentage of participants|||Number
1233012|NCT00637156|Secondary|Arm Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
1233013|NCT00637156|Secondary|Neck Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
1233014|NCT00637156|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
1233015|NCT00637156|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
1233104|NCT00636220|Primary|Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity|Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.|1 to 3 days||||samples|||Number
1233016|NCT00637156|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;~Maintenance or improvement in neurological status;~No serious adverse event classified as implant associated or implant/surgical procedure associated; and~No additional surgical procedure classified as a “failure.”"|24 Months|The primary analysis dataset for this study included all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 199 investigational subjects and 160 control subjects.|||percentage of participants|||Number
1233017|NCT00637000|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|"Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.~Severity was graded by the investigator as mild (grade 1), moderate (grade 2) and severe (grade 3)."|Day 1-6|The randomized population included all subjects who were randomized to soluble films and received at least one dose of soluble films.|||participants|||Number
1233018|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Does the Drug Make You Sick?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug make you sick?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233019|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Like the Drug?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you like the drug?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233020|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Does the Drug Have Any Bad Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug have any bad effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233021|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Feel Any Good Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any good effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233022|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Feel Any Drug Effect?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any drug effect?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233038|NCT00636961|Secondary|Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14|The modified Borg CR10 Scale consists of 12-point score that the patients point to so as to indicate their level of dyspnoea (where 0 indicates no breathlessness at all to 12 indicates maximum breathlessness), before and during exercise testing. A reduction in this score indicates an improvement. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests. Peak time was defined as the last measurement taken in the exercise period. Analysis of variance included period, treatment and sequence as fixed effects and subject as random effect.|Day 1, Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Score on a scale||90% Confidence Interval|Least Squares Mean
1233023|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: How High Are You?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233024|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Make You Sick?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug make you sick?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233025|NCT00637000|Secondary|CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Do You Like the Drug?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you like the drug?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233026|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Have Any Bad Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug have any bad effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233027|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Have Any Good Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any good effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233028|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Do You Feel Any Drug Effect?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any drug effect?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233039|NCT00636961|Secondary|Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14|Dyspnoea was measured during the treatment period using the transition dyspnoea index (TDI), which captures changes from baseline. The TDI has three domains; functional impairment, magnitude of task and magnitude of effort. TDI domains are rated from -3 (major deterioration) to 3 (major improvement) and rates are summed for transition focal score ranging from -9 to 9; minus scores indicate deterioration. A TDI focal score of 1 was considered to be a clinically significant and meaningful improvement from baseline. Analysis of variance included period baseline dyspnoea index (BDI) as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Score on a scale||90% Confidence Interval|Least Squares Mean
1233029|NCT00637000|Secondary|"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: How High Are You?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high.~The baseline VAS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak VAS was the highest VAS score obtained between 1-23.5 hours post administration on Day 1."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233030|NCT00637000|Secondary|Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5)|Pupil diameter was measured at the end of induction (47.5 hours after the first administration of study intervention) and at intervals during the post-induction period (Days 3-5). Peak post induction measurement is the minimum pupil diameter recorded during days 3-5.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||mm||Standard Deviation|Mean
1233031|NCT00637000|Secondary|Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration|Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the minimum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.|Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||mm||Standard Deviation|Mean
1233032|NCT00637000|Secondary|Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration|Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the maximum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.|Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||mm||Standard Deviation|Mean
1233033|NCT00637000|Secondary|Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction|"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.~The end of induction COWS was the score obtained 47.5 hours after first administration of soluble films on Day 1. Peak post induction COWS was the highest COWS score obtained on Days 2-5."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233034|NCT00637000|Primary|Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration|"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.~The baseline COWS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak COWS was the highest COWS score obtained between 1-23.5 hours post administration on Day 1."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
1233035|NCT00636987|Primary|Characterize the Hemodynamic Performance of the Valve|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.~Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve."|5 Year|Number of participants that completed the visit and assessment|||mmHg||Standard Deviation|Mean
1233036|NCT00636987|Primary|Characterize Patient NYHA Functional Classification Status|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|5 year|Number of participants that completed the visit and assessment|||participants|||Number
1233040|NCT00636961|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose. The linear mixed model included the baseline FEV1 measurement as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Liters||90% Confidence Interval|Least Squares Mean
1233041|NCT00636961|Secondary|Static Inspiratory Capacity (IC) at Day 14|Inspiratory Capacity (IC) at resting (static IC) was measured by using whole body plethysmography. The day 14 measurement was analyzed using an analysis of variance including baseline (day -2) as a covariate,|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Liters||90% Confidence Interval|Least Squares Mean
1233042|NCT00636961|Primary|Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14|Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Liters||90% Confidence Interval|Least Squares Mean
1233043|NCT00636818|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.|8 Weeks|Number of participants who received at least one dose of study drug.|||participants|||Number
1233044|NCT00636818|Secondary|Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion|The Fridericia correction of the QT interval (QTcF) was used.|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.|||participants|||Number
1233045|NCT00636818|Secondary|Significant Changes in Body Weight During the Study|Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%.|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.|||participants|||Number
1233046|NCT00636818|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study|Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.|||participants|||Number
1233047|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)|SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score*10+50 in each subscale. Range cannot be specified in norm-based scores.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||T-Score||Standard Deviation|Mean
1233048|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Stroop Color Word Test|This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||number of correct answers||Standard Deviation|Mean
1233049|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)|The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1233050|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1233051|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score|Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1233052|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1233053|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score|Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1233054|NCT00636818|Primary|Discontinuations Due to Adverse Events (AE)|The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.|Baseline to 8 Weeks|Number of participants who received at least one dose of study drug.|||participants|||Number
1233055|NCT00636805|Secondary|Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy by Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR)|Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from the mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue. Acute CINV complete response (CR) is defined as not having an emetic episode or any use of antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Baseline through day 5 of the first week of chemotherapy|Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy|||units on a scale||95% Confidence Interval|Mean
1233056|NCT00636805|Secondary|Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy|Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue.|Baseline through day 5 of the first week of chemotherapy|Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy|||units on a scale||95% Confidence Interval|Mean
1233057|NCT00636805|Secondary|Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities|Percentage of patients with ≥ grade 3, treatment-related toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|6 weeks||||participants|||Number
1233058|NCT00636805|Secondary|Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate|Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during days 2 through 5 of chemotherapy treatment during the first cycle of treatment|Days 2-5 of the first week of chemotherapy|Intent-to-treat; 10 patients did not complete the study measure for days 2-5 of the first week of chemotherapy|||percentage of participants||95% Confidence Interval|Number
1233059|NCT00636805|Secondary|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Day 1 of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy|||percentage of participants||95% Confidence Interval|Number
1233060|NCT00636805|Secondary|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Day 1 of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy|||percentage of participants||95% Confidence Interval|Number
1233061|NCT00636805|Primary|Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|first 24 hours of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy|||percentage of participants||95% Confidence Interval|Number
1233062|NCT00636792|Secondary|Number of Participants With Overall Response (Complete and Partial Response)|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.|12 weeks after the last subject completes their end of treatment visit||||participants|||Number
1233063|NCT00636792|Primary|Number of Participants With Complete Response|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.|12 weeks after the last subject completes their end of treatment visit.|Response-evaluable population is defined at patients treated with 90 mg/m^2 bendamustine, received at least one dose of any study drug, and had at least one post baseline response assessment.|||participants|||Number
1233283|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|60 minutes||||units on a scale||Standard Deviation|Mean
1233064|NCT00636701|Primary|Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks|Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .|Baseline (day 0) and 2 weeks|Four right‐handed healthy volunteers (two men, aged 20–50 years) participated in a double‐blind study of primed and unprimed rTMS.|||percentage change of BOLD||Standard Deviation|Mean
1233065|NCT00636675|Secondary|Change in Weighted Average of Staff Interaction Scales|This is a summary measure of 7 staff surveys using the weighted average on a 1-5 Likert scale with 5 indicating the highest (best) quality. Scales include Communication Openness, Accuracy, and Timeliness; Participation in Decision Making, Local Interaction Strategies, Safety Climate, and Staff Perceptions of Quality. Number presented is the change from baseline attributable to the intervention. Higher numbers represent a greater change attributable to the intervention.|baseline to post intervention, an average of 6 months||||units on a scale||Standard Error|Mean
1233066|NCT00636675|Secondary|Fall Rates|Numerator: number of falls occurring in a 6 month period, denominator: number of bed days for resident. Rate adjusted for baseline rate and casemix. Note that this measure is NOT related to staff but rather residents in the nursing home. The residents were not considered enrolled participants in the study.|6 months post intervention|Residents with at least one prior fall|||fall rate||Inter-Quartile Range|Median
1233067|NCT00636675|Primary|Fall Related Process Measures|Mean of the total number of fall risk reduction indicators (steps staff have taken to reduce fall risk) that were documented in residents with high fall risk. These included orthostatic blood pressure measurement/intervention; sensory impairment evaluation/intervention; footwear; exercise/assistive device intervention; toileting schedule; environmental modification; psychoactive medication reduction; and vitamin D supplements. Note that this measure is NOT related to staff but rather residents in the nursing home, therefore the numbers are different from participant flow. The residents were not considered enrolled participants in the study.|6 months post intervention|Residents with prior fall|||number of fall risk reduction indicators||Standard Deviation|Mean
1233068|NCT00636649|Secondary|Number of Participants Who Had a 50% Reduction in NEQ Scores|The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.|Week 12||||participants|||Number
1233069|NCT00636649|Secondary|Number of Participants Who no Longer Meet the NESHI Criteria|The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.|Week 12||||participants|||Number
1233070|NCT00636649|Secondary|Change in Weight||Baseline, 12 week||||kg||Standard Error|Mean
1233071|NCT00636649|Secondary|Change in Glucose||Baseline, 12 Week||||mg/dL||Standard Error|Mean
1233072|NCT00636649|Secondary|Change in Beck Anxiety Inventory (BAI) Score|The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.|Baseline, 12 weeks||||units on a scale||Standard Error|Mean
1233073|NCT00636649|Secondary|Change in Lipid Panel||Baseline,12 weeks||||mg/dL||Standard Error|Mean
1233074|NCT00636649|Secondary|Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2|The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.|12 weeks||||participants|||Number
1233075|NCT00636649|Secondary|Change in Three Factor Eating Questionnaire (TFEQ)|"The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.).~RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale"|Baseline, 12 weeks||||units on a scale||Standard Error|Mean
1233076|NCT00636649|Secondary|Change in Perceived Stress Scale (PSS)|The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.|12 weeks|Participants who completed PSS assessment at baseline and week 12.|||units on a scale||Standard Error|Mean
1233088|NCT00636441|Secondary|Economic Impact of Using Genomic Assessment to Guide Management.|Economic Impact (i.e., cost of care) will be calculated by first assessing the quantity of clinical resources used by each patient in the study arm, and then assigning a cost to each resource using cost information derived from a costing study to be undertaken outside of this protocol.|5 years|Since these data were not collected, this analysis could not be done.||||||
1233089|NCT00636441|Secondary|Overall Survival|Overall survival is defined as the time from enrollment to death due to any cause. The 2-year overall survival rate is estimated with the Kaplan-Meier method.|2 years|All eligible treated patients with known follow-up status.|||Estimated % of participants surviving||95% Confidence Interval|Number
1233077|NCT00636649|Secondary|Change in Coping Inventory for Stressful Situations (CISS)|TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.|Baseline, 12 weeks||||t-scores||Standard Error|Mean
1233078|NCT00636649|Secondary|Change in Beck Depression Inventory II (BDI-II) Score|The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.|Baseline, 12 weeks||||units on a scale||Standard Error|Mean
1233079|NCT00636649|Primary|Night Eating Questionnaire|The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.|baseline, 12 weeks|Data were analyzed as intent-to-treat with all 40 patients included in the analysis. Primary endpoint was change in the NEQ total score, i.e., difference between values between Week 12 (study exit) and baseline. Analysis of covariance was the primary statistical procedure with baseline NEQ score and baseline BMI as covariates.|||units on a scale||Standard Error|Mean
1233080|NCT00636636|Other Pre-specified|Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score|Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in last observation carried forward (LOCF) average daily pain score from baseline to final week of efficacy treatment period (Week 10).|10 weeks||||Scores on a scale||Standard Error|Least Squares Mean
1233081|NCT00636636|Secondary|Average Daily Sleep Interference Score|Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10).|10 weeks||||Scores on a scale||Standard Error|Least Squares Mean
1233082|NCT00636636|Secondary|Clinical Global Impression of Change (CGIC)|"Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)."|10 weeks||||Participants|||Number
1233083|NCT00636636|Secondary|Patient Global Impression of Change (PGIC)|"Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)."|10 weeks|ITT, BOCF|||Participants|||Number
1233084|NCT00636636|Primary|Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score|Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10).|10 weeks|ITT, BOCF|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1233085|NCT00636610|Secondary|Progression-free Survival (PFS) in Patients With Various Degrees of Hedgehog Antigen Tumor Expression|Indian + Sonic Hedgehog antigen expression was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from archival tumor tissue taken from each patient prior to enrollment in the study. Results are reported in 3 categories; the 33% of patients with the lowest level of expression, the 35% of patients with a middle level of expression, and the 32% of patients with the highest level of expression. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason.|From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 64 patients in the vismodegib group and 75 patients in the placebo group.|||Months||90% Confidence Interval|Median
1233086|NCT00636610|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.|From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks|Intent-to-treat patient population: All randomized patients.|||Months||90% Confidence Interval|Median
1233087|NCT00636441|Secondary|Patients' Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for PST of Early-stage Breast Cancer.|A short questionnaire was administered at baseline (the day chemotherapy was started) and following post-surgical medical oncology evaluation to assess the patient’s understanding of the study being conducted, and the patient’s expectations of the treatment. Due to space limitations, the full survey is presented in the Detailed Description.|1 year|The overall enrollment was insufficient to provide for any substantive analysis.||||||
1233090|NCT00636441|Secondary|Sites of Recurrence|Sites of Recurrence is a categorical outcome whose possible values are the organ-specific sites at which disease recurrence was observed. A patient may recur at more than one site.|10 years|All eligible treated patients. Four of these 38 participants experienced recurrence of their breast cancer; two of the four patients had multiple sites of recurrence.|||participants|||Number
1233091|NCT00636441|Secondary|Disease-free Survival|Disease-free survival is defined as the length of time from enrollment to local or distant disease recurrence, whichever comes first; disease-free deaths are censored. The 2-year disease-free survival rate is estimated with its 95% confidence interval.|2 years|All eligible treated patients were used in this analysis.|||estimated % of participants disease-free||95% Confidence Interval|Number
1233092|NCT00636441|Secondary|Clinical Response Using WHO Criteria|"WHO criteria are based on the sum of the products of the longest axis and the longest perpendicular axis. Bi-dimensional measurements were taken of all breast lesions and axillary nodes using the best imaging modality performed after completion of assigned therapy.~Clinical Complete Response (cCR): Disappearance of all target lesions by physical exam and best imaging modality.~Clinical Partial Response (cPR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum LD at treatment initiation. Patients having a documented response with no reconfirmation of the response will be listed with stable disease.~Progression (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesion."|12 weeks, 2-3 weeks after the fourth cycle of chemotherapy|All eligible treated patients were used in this analysis.|||participants|||Number
1233093|NCT00636441|Secondary|To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt.|The percentage of patients who had breast-conserving surgery at first attempt, measured only in patients with T2 tumors classified as potential candidates for breast conservation.|6 months|Data from all eligible patients with non-missing values on this outcome were used.|||percentage of T2 tumor patients||95% Confidence Interval|Number
1233094|NCT00636441|Secondary|Percentage of Patients Who Had Breast-conserving Surgery With Negative Margins|The percentage of patients who had breast-conserving surgery with negative margins, measured in patients with T2 and T3 tumors classified as requiring mastectomy at baseline.|6 months|Since final margin status was not collected, this analysis could not be done.||||||
1233095|NCT00636441|Secondary|Probabilities of Being Sensitive to AC and TC as Determined by the Patient’s Genomic Signatures|To determine in early stage breast cancer treated with PST whether genomic profiling can identify drug-sensitive and drug-resistant patients including a comparison of subgroups for the two individual regimens (i.e. AC and TC). To determine if the 60% cutoff for the genomic profiles is optimal in predicting the response to chemotherapy regimens.To describe the performance of the genomic profiles in assessing the relative responsiveness of: 1) Patients predicted to be resistant to both chemotherapy regimens; and 2) Patients randomly assigned to one treatment whose genomic profiles suggest receiving the other regimen (in both AC and TC subgroups).|10 years|This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates||||||
1233096|NCT00636441|Primary|Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer|Pathological complete response (pCR) was defined as the disappearance of all invasive disease in the breast or if only residual in situ or lymph node disease is found. The pCR rate is presented with its 95% confidence interval for the Guided and Non-guided arms.|4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks|All eligible treated patients. The three patients not included are two who had allergic reactions to the assigned treatment, and one with metastatic disease on biopsy of a spine lesion at the end of assigned treatment so never went to surgery.|||percentage of participants||95% Confidence Interval|Number
1233097|NCT00636389|Primary|A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.|Overall removal of urea, phosphorus and β2-microglobulin was determined from the pre- to post-dialysis change in plasma concentration and from the amount of solute recovered in the dialysate. This outcome measure is reported as the percentage of pre- to post-dialysis reduction of urea, phosphorus and β2-microglobulin.|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments||||Percentage of reduction||Standard Deviation|Mean
1233098|NCT00636389|Secondary|Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H|Assessment of blood side priming: 1=Very Easy 2=Acceptable 3=Difficult 4=Very Difficult / Assessment of dialysate side priming: 1=Perfect 2=Acceptable 3= Not Acceptable / Appearance of dialyzer fibers: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of dialyzer arterial header: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of venous header: 1=Very Good 2=Good 3=Poor 4=Very Poor /|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments|Each of the 12 subjects underwent three consecutive treatments with the HD-C4 and three consecutive treatments with the Polyflux 210H.|||Units on a Scale 1 = Best|dialyzers|Standard Deviation|Mean
1233099|NCT00636389|Primary|Comparison of Urea Removal Under Conditions of Routine Hemodialysis.|Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V.|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments||||ratio||Standard Deviation|Mean
1233100|NCT00636363|Primary|Contact Lens Deposits|Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.|At each visit for 3 months|Lens deposits, All eligible, dispensed eyes.|||Eyes|Participants||Number
1233101|NCT00636363|Primary|Subjective Responses to Comfort Related Symptoms/Complaints|Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.|Over 4 visits for the 3 month period|Comfort related symptoms/complaints for all eligible, dispensed eyes. Over all follow-up visits.|||Scores on a Scale|Participants|Standard Deviation|Mean
1233102|NCT00636363|Primary|Slit-lamp Findings > Grade 2|eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.|Over 4 visits for 3 month period|Over all follow-up visits, all dispensed eyes|||participants|Participants||Number
1233105|NCT00636207|Primary|Cmax Accumulation Ratio of Montelukast - Multiple Doses|The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.|up to 10 days after first dose of study drug|Per Protocol Population: All participants who complied with the protocol|||ratio|||Number
1233106|NCT00636207|Primary|AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses|The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.|up to 10 days after first dose of study drug|Per Protocol Population: All participants who complied with the protocol|||ratio|||Number
1233107|NCT00636207|Primary|t1/2 of Montelukast - Multiple Doses|Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||hours||Standard Deviation|Mean
1233108|NCT00636207|Primary|Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose|Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||hours||Standard Deviation|Mean
1233109|NCT00636207|Primary|Tmax of Montelukast - Multiple Doses|Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||hours||Full Range|Median
1233110|NCT00636207|Primary|Time to Cmax (Tmax) of Montelukast - Single Dose|Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||hours||Full Range|Median
1233111|NCT00636207|Primary|Cmax of Montelukast - Multiple Doses|Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||ng/mL||Standard Deviation|Mean
1233112|NCT00636207|Primary|Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose|Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||ng/mL||Standard Deviation|Mean
1233113|NCT00636207|Primary|AUC 0-24hr of Montelukast - Multiple Doses|Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||ng/mL*hr||Standard Deviation|Mean
1233114|NCT00636207|Primary|Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose|Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||ng/mL*hr||Standard Deviation|Mean
1233115|NCT00636207|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 7 days after last dose of study drug|Safety Population: All participants who received at least one dose of study drug|||participants|||Number
1233116|NCT00636207|Primary|Number of Participants Who Experienced At Least One Adverse Event||Up to 14 days after last dose of study drug|Safety Population: All participants who received at least one dose of study drug|||participants|||Number
1233117|NCT00636194|Secondary|Graded Slit Lamp Findings > Grade 2|Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.|2 week follow-up visit|All dispensed, completed eyes|||eyes|Participants||Number
1233118|NCT00636194|Secondary|Symptoms and Complaints|Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.|2 weeks|All eligible, dispensed eyes|||Score on a scale|Participants|Standard Deviation|Mean
1233119|NCT00636194|Primary|Subjective Assessment of Comfort and Cleanliness|Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.|7 days|All eyes|||Scores on a scale|Participants|Standard Deviation|Mean
1233120|NCT00636168|Secondary|Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint|Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scales linearly transformed to 0-100 scales. Higher scores for Global Health Status indicate better HRQoL. An increase from baseline indicates improvement in HRQoL compared to baseline. HRQoL was administered within 1 week prior to first dose (baseline) and on Days 22, 43, 64 (+/- 3 days), Week 24 and every 12 weeks up to 2 years, independent of disease progression.|Baseline up to 2 years from randomization|All randomized patients (ITT) analyzed in the arm to which they were allocated by randomization were analyzed. At timepoint level, all randomized patients (ITT) with a measurement at the timepoint were considered.|||units on a scale||Standard Deviation|Mean
1233121|NCT00636168|Secondary|Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events|P-Y = person-years of exposure. Incidence rate per 100 person-years of exposure (IR/100 P-Y) was calculated as event count * 100 /person-years of exposure. MedDRA Version: 16.1. Duplicate AEs have been eliminated and overlapping and contiguous occurrences of the same event have been collapsed.|Day 1 up to 70 days after last dose or last known alive date for participants still being dosed; up to 5 years|All patients who received at least one dose of ipilimumab or placebo, adjusted for person-years (P-Y) of exposure; P-Y=440.5; P-Y=728.1 for ipilimumab and placebo, respectively.|||events/100 person-years of exposure|||Number
1233284|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|30 minutes||||units on a scale||Standard Deviation|Mean
1233122|NCT00636168|Secondary|Number of Patients With Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population|AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator’s assessment of immune-mediated etiology [excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)]. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death.|Day 1 up to 70 days after last dose or last known alive date for patients still being dosed; up to 5 years|All patients who received at least one dose of treatment were analyzed. Patients were analyzed in their randomized group provided they received the randomized treatment at least once; those who received incorrect medication for the entire treatment period were analyzed in the group associated with the incorrect medication.|||participants|||Number
1233123|NCT00636168|Secondary|Rate of Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death. For those participants who have not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.|From date of randomization to date of death, assessed up to 5 years|Intent to Treat Population|||Percentage of participants||95% Confidence Interval|Number
1233124|NCT00636168|Secondary|Number of Patients With Distant Metastasis or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A patient who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.|From June 2008 to January 2016 (approximately 90 months)|Intent to Treat Population|||Participants|||Count of Participants
1233125|NCT00636168|Primary|Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population|RFS was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A patient who died without reported recurrence was considered to have recurrence on the date of death. For those who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. CT and MRI were mandatory to establish recurrence. Yearly recurrence-free survival rates, eg. at 1 year, defined as the probability that a participant was recurrence-free at 1 year following randomization, were estimated for each treatment group using the Kaplan-Meier product-limit method, along with their corresponding log-log transformed 95% confidence intervals.|Randomization up to Years 1, 2, and 3|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.|||Percent Probability||95% Confidence Interval|Number
1233126|NCT00636168|Primary|Number of Patients With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Recurrence was defined as appearance of one or more new melanoma lesions: local, regional or distant metastasis. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. A patient who died without reported recurrence was considered to have recurred on the date of death. Disease was assessed at randomization and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.|Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.|||participants|||Number
1233127|NCT00636168|Primary|Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Recurrence free survival (RFS) was programmatically determined based on the disease recurrence data provided by the IRC and was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A patient who died without reported recurrence was considered to have recurrence on the date of death. For those patients who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. The primary analysis was event-driven and planned when at least 512 RFS events assessed per IRC were collected.|Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.|||months||95% Confidence Interval|Median
1233128|NCT00636155|Secondary|Overall Survival||5 years|All patients who received treatment|||months||95% Confidence Interval|Median
1233129|NCT00636155|Secondary|Progression Free Survival|Progression is defined as at least one of the following: 1) ≥ 50% increase in the sum of the products of at least two lymph nodes one two consecutive determinations (at least one node must be ≥ 2 cm); appearance of new palpable lymph nodes, 2) ≥ 50% increase in the size of the liver and/or spleen; appearance of palpable hepatomegaly or splenomegaly, which was not previously present, 3) ≥ 50% increase in the absolute number of circulating lymphocytes to at least 5,000/µl or 4)Transformation to a more aggressive histology.|5 years|All patients who received treatment|||months||95% Confidence Interval|Median
1233130|NCT00636155|Primary|Number of Patients With an Overall Response (Complete Response + Partial Response)|Overall Response is the total number of participants with a Complete (CR) or Partial (PR) response. CR requires the absence of lymphadenopathy, hepatomegaly or splenomegaly and constitutional symptoms and a normal CBC; bone marrow must be at least normocellular for age, with less than 30% nucleated cells being lymphocytes with no lymphoid nodules. Partial Response: requires ≥ 50% decrease in one of the following: peripheral blood lymphocyte count, lymphadenopathy, enlargement of liver and/or spleen, or bone marrow involvement by CLL AND at least one hematologic parameter met for 2 months.|every 3 cycles|Patients completing at least 2 cycles of treatment|||participants|||Number
1233131|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||whole blood clearance B2-microglobulin||Standard Error|Mean
1233132|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||KoA for b2-microglobulin (mL/min)||Standard Error|Mean
1233133|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||whole blood phosphorus clearance mL/min||Standard Error|Mean
1233134|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||KoA for Phosphorus (mL/min)||Standard Error|Mean
1233135|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||Whole blood urea clearance (mL/min)||Standard Error|Mean
1233136|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.|KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size.|During the third treatment with each dialyzer (one time during each trial period week)||||KoA for urea (mL/min)||Standard Error|Mean
1233137|NCT00635999|Secondary|Within-group Change Represented as Cohen's d Effect Sizes|Cohen's d within-group effect sizes comparing pre-therapy assessment to assessment at 10-14 days after last therapy session, at 6-month follow-up, at 12-month follow-up, and at 24-month follow-up. Findings reported in table are Cohen's d effect sizes averaged over Hamilton Anxiety Scale (scores ranging from 0-56, higher scores mean more anxiety), the Assessor Severity Scale (scores ranging from 0-8, higher scores mean more severity), and the State-Trait Anxiety Inventory-Trait version (scores ranging from 20-80, higher scores mean more state anxiety). The within-group effective sizes are the posttherapy [or follow-up] mean minus pretherapy mean divided by the pretherapy standard deviation.|10-14 days after last therapy session and months 6, 12, and 24 following last therapy session|People who completed treatment|||Cohen's d within group effect size|||Number
1233138|NCT00635999|Primary|High End State Function|Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire)|10-14 days after last therapy session and months 6, 12, and 24 following last therapy session|People who completed treatment|||% people meeting high endstate status|||Number
1233139|NCT00635882|Other Pre-specified|Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)||Baseline||||ppb||Standard Deviation|Mean
1233140|NCT00635882|Secondary|Change From Baseline in PM PEF at Days 1-15||Baseline and Days 1-15|All randomized participants|||liters/minute||Standard Deviation|Mean
1233141|NCT00635882|Secondary|Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15||Baseline and Days 2-15|All randomized participants|||liters/minute||Standard Deviation|Mean
1233142|NCT00635882|Secondary|Change From Baseline in PM Total Asthma Symptom Score at Days 1-15|Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.|Baseline and Days 1-15|All randomized participants|||units on a scale||Standard Deviation|Mean
1233143|NCT00635882|Secondary|Change From Baseline in AM Total Asthma Symptom Score at Days 2-15|Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.|Baseline and Days 2-15|All randomized participants|||units on a scale||Standard Deviation|Mean
1233144|NCT00635882|Secondary|Mean Change From Baseline to Day 15 of Mannitol Challenge|Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1).|Baseline to Day 15|All randomized participants|||milligrams||Standard Deviation|Mean
1233145|NCT00635882|Secondary|Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage)||Baseline to Day 14|All randomized participants|||percentage of Sputum Eosinophil Count||Standard Deviation|Mean
1233146|NCT00635882|Secondary|Mean Percent Change From Baseline to Day 7 in eNO Ppb||Baseline to Day 7|All Randomized Participants|||percentage of eNO||Standard Deviation|Mean
1233147|NCT00635882|Primary|Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)||Baseline to Day 14|All Randomized Participants|||percentage of eNO||Standard Deviation|Mean
1233198|NCT00635570|Post-Hoc|Continuation Rate|Rate of intention to continue the contraceptive method at 6 months|at 6 month (3 month after the end of the study period)|At 6 months, four from the contraceptive vaginal ring group and three from the oral contraceptive pill group did not complete the 6-month survey and thus were excluded from analysis.|||Percentage of Participants|||Number
1233148|NCT00635830|Primary|Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination|All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination||||Participants|||Number
1233149|NCT00635817|Post-Hoc|Percentage of Participants With a Decrease From Baseline in the Ratio of Bone Age to Chronological Age at Month 6 Compared to Baseline|The ratio at baseline or Month 6 was calculated as bone age at baseline or Month 6/chronological age at baseline or Month 6. The percentage of participants with a decrease in the ratio was calculated as a simple percentage for each dose group. Observed data were used with no imputation for missing data. The baseline time frame was increased from the secondary outcome in this analysis to include all participants with a bone age radiograph at screening. This analysis was performed after the clinical study report was completed & is included to match the FDA package insert.|Baseline to Month 6|The baseline time frame was increased from the secondary outcome to this analysis to include all participants with a bone age radiograph at screening. This analysis was performed post hoc to match the FDA package insert.|||Percentage of Participants|||Number
1233150|NCT00635817|Post-Hoc|Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (< 4 mIU/mL) From Month 2 Through Month 6 (Simple Percentage With Binomial Exact Confidence Intervals)|Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a GnRHa stimulation test at Mo 2, 3, and 6. A simple percentage and binomial exact confidence intervals were used in this analysis. Participants who withdrew with luteinizing hormone that remained suppressed were counted as a success. This analysis was performed after the clinical study report was completed and is included to match the FDA package insert.|Month 2 through 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
1233151|NCT00635817|Secondary|Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6|The ratio at Month 6 was calculated as (bone age at Month 6 - bone age at baseline)/(chronological age at Month 6 - chronological age at baseline). Observed data were used with no imputation for missing data. Baseline bone-age radiograph was performed at or within 3 months of the Screening Visit.|Baseline to Month 6|Participants must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Ratio||Standard Deviation|Mean
1233152|NCT00635817|Secondary|Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6|The growth rate at baseline was the growth rate during the last year before the start of treatment and was calculated with the measurement closest to Day -336 (before Day -30) and the measurement up to Day 1. Growth rate at Month 6 was defined as the ratio of the change in height from Day 1 to the change in chronological age, with an approximate 6-month interval between the 2 height measurements. Observed data were used with no imputation for missing data.|Baseline and Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||cm/year||Standard Deviation|Mean
1233153|NCT00635817|Secondary|Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6|Percentage of participants with suppression of genital development and testicular volume, out of the number of boys with pubertal staging of genital development or testicular volume (n/N%). Only boys are analyzed in this outcome measure. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.|Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
1233154|NCT00635817|Secondary|Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6|Percentage of participants with suppression of breast development, out of the number of girls with pubertal staging of breast development (n/N%). Only girls are analyzed in this outcome measure. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.|Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
1233155|NCT00635817|Secondary|Peak-stimulated Luteinizing Hormone Concentration by Visit|Observed data were used with no imputation for missing data.|Baseline, Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||mIU/mL||Standard Deviation|Mean
1233156|NCT00635817|Secondary|Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit|Percentage of participants with suppression of testosterone, out of the number of boys with at least 1 testosterone measurement at each visit (n/N%). Only boys are analyzed in this outcome measure. Observed data were used with no imputation for missing data.|Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
1233157|NCT00635817|Secondary|Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit|Percentage of participants with suppression of estradiol, out of the number of girls with at least 1 estradiol measurement at each visit (n/N%). Only girls are analyzed in this outcome measure. Observed data were used with no imputation for missing data.|Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
1233158|NCT00635817|Primary|Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6|Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone >= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.|Month 2 through 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
1233159|NCT00635804|Secondary|Maximum HCV Viral Load Change From Baseline Over Study Following MK-3281 Dosing For 7 Days|For evaluation of MK-3281 antiviral activity, the maximum reduction in HCV ribonucleic acid (RNA) levels over the course of the study was assessed by MK-3281 dose group in HCV+ participants and the mean maximum viral load reduction was summarized. HCV RNA levels were measured at predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours postdose on Day 1 and Day 7; pre-morning (AM) and pre-evening (PM) dose Day 2; and pre AM dose Days 3-6. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing, and change from baseline (difference) was calculated at each time point. The response for that participant was defined as: − (postbaseline time point − baseline) at the time point with the lowest HCV RNA level.|Baseline (pre-dose Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7|Treated HCV+ participants in Part II with available HCV RNA data. 800 mg dose group contained members of Panels E and F. No healthy participants from Part 1 (Panels A, B, C, or D) were assessed for this outcome measure.|||log(IU/ml)||95% Confidence Interval|Mean
1233160|NCT00635804|Secondary|C12hr Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 C12hr accumulation ratio was calculated for HCV+ participants and healthy participants. C12hr accumulation ratio calculated for healthy participants as Day 10 C12hr / Day 1 C12hr. C12hr accumulation ratio calculated for HCV+ participants as Day 7 C12hr / Day 1 C12hr.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||ratio||90% Confidence Interval|Geometric Mean
1233161|NCT00635804|Secondary|Cmax Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 Cmax accumulation ratio was calculated for HCV+ participants and healthy participants. Cmax accumulation ratio calculated for healthy participants as Day 10 Cmax / Day 1 Cmax. Cmax accumulation ratio calculated for HCV+ participants as Day 7 Cmax / Day 1 Cmax.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||ratio||90% Confidence Interval|Geometric Mean
1233162|NCT00635804|Secondary|AUC (0-12hr) Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 AUC(0-12hr) accumulation ratio was calculated for HCV+ participants and healthy participants. AUC(0-12hr) accumulation ratio calculated for healthy participants as Day 10 AUC (0-12hr) / Day 1 AUC (0-12hr). AUC(0-12hr) accumulation ratio calculated for HCV+ participants as Day 7 AUC (0-12hr) / Day 1 AUC (0-12hr).|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||ratio||90% Confidence Interval|Geometric Mean
1233163|NCT00635804|Secondary|Apparent Half-Life (t ½) of MK-3281|Blood samples were obtained from participants and MK-3281 apparent t ½ was calculated at Day 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay. Harmonic mean t ½ and pseudo standard deviation were reported.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose on Day 7 (HCV+ participants) or Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||hour||Standard Deviation|Mean
1233164|NCT00635804|Secondary|Time To Reach Cmax (Tmax) of MK-3281|Blood samples were obtained from participants and MK-3281 Tmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||hour||Full Range|Median
1233165|NCT00635804|Secondary|12-Hour Concentration of MK-3281 in Plasma (C12hr)|Blood samples were obtained from participants and MK-3281 plasma C12hr was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||μM||Geometric Coefficient of Variation|Geometric Mean
1233166|NCT00635804|Secondary|Maximum Plasma Concentration (Cmax) of MK-3281|Blood samples were obtained from participants and MK-3281 Cmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||μM||Geometric Coefficient of Variation|Geometric Mean
1233199|NCT00635570|Secondary|Continuation Rate|Rate of intention to continue the contraceptive method at 3 months|at 3 months|26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)|||Percentage of Participants|||Number
1233167|NCT00635804|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time 12 Hours (AUC[0-12]) of MK-3281|Blood samples were obtained from participants and MK-3281 AUC(0-12) was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
1233168|NCT00635804|Primary|Number of Participants Who Discontinued Study Medication Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Up to 14 days after the last dose of study drug (up to 24 days maximum)|All Treated Participants|||participants|||Number
1233169|NCT00635804|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Up to 14 days after the last dose of study drug (up to 24 days maximum)|All Treated Participants|||participants|||Number
1233170|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 53|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 53|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 53|||Percent change||Full Range|Median
1233171|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 49|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 49|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 49|||Percent change||Full Range|Median
1233172|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 45|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 45|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 45|||Percent change||Full Range|Median
1233173|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 41|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 41|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 41|||Percent change||Full Range|Median
1233174|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 37|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 37|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 37|||Percent change||Full Range|Median
1233175|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 33|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 33|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 33|||Percent change||Full Range|Median
1233176|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 29|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 29|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 29|||Percent change||Full Range|Median
1233200|NCT00635570|Secondary|Satisfaction Rate||at 3 months|26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)|||Percentage of Participants|||Number
1233177|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 25|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 25|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 25|||Percent change||Full Range|Median
1233178|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 21|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 21|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 21|||Percent change||Full Range|Median
1233179|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 17|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 17|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 17|||Percent change||Full Range|Median
1233180|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 13|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 13|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 13|||Percent change||Full Range|Median
1233181|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 9|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 9|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 9|||Percent change||Full Range|Median
1233182|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 5|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 5|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 5|||Percent change||Full Range|Median
1233183|NCT00635778|Secondary|Number of Participants With a Positive Human-anti-humanized-antibody (HAHA) Titer|The formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 3, Week 5, pre-dose every 8 subsequent weeks, and end of treatment (post-study: 4 weeks after last dose of study drug). Positive HAHA status for a participant is defined as testing positive on both the screening and immunodepletion assays at one or more visits.|Prior to second and subsequent doses of study drug (Up to 1 year post-first dose)|All participants who received one dose of study therapy.|||Participants|||Count of Participants
1233184|NCT00635778|Secondary|Percent Change From Baseline in Serum Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Level at Week 1|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 1|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 1.|||Percent change||Full Range|Median
1233185|NCT00635778|Secondary|Number of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)|Complete Response (disappearance of all target lesions) or Partial Response (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) using Response Criteria in Solid Tumors (RECIST). Tumor response was assessed prior to first dose and every 8 weeks beginning pre-dose of Week 9 for up to 18 months. The best response out of all measurements for each participant was used for determining CR and PR.|Up to 18 months post first dose of study drug|All participants who received at least one dose of study therapy.|||Participants|||Count of Participants
1233201|NCT00635570|Primary|Adherence Rate (Rate of Perfect Method Use)|"Perfect use was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles"|For the first 3 months||||Percentage of Participants|||Number
1233285|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
1233186|NCT00635778|Primary|Number of Participants Who Experience One or More Dose- Limiting Toxicities (DLTs)|Dose-limiting toxicities (DLT) were assessed and graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE). A DLT was defined as the occurrence of any of the following events, that were judged by the study investigator, to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5 degrees Celsius; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity (except alopecia and inadequately treated diarrhea, nausea, and vomiting, and hyperglycemia lasting less than 5 days; and Grade 3 or greater hyperglycemia lasting for more than 5 days in spite of optimal medical management.|The entire treatment period (Up to 18 months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
1233187|NCT00635778|Primary|Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose|Blood samples were obtained for analysis of steady-state serum concentration of dalotuzumab at 336 hours (C336) after the first maintenance dose of dalotuzumab. The C336 of dalotuzumab after intravenous administration is presented.|2 weeks post first maintenance dose of study drug (3 weeks post loading dose of study drug)|All participants who received dalotuzumab and had blood samples drawn for pharmacokinetic (PK) analyses.|||μg/mL||Standard Deviation|Mean
1233188|NCT00635700|Secondary|Improvement SOPS Total Score||8 weeks|||||||
1233189|NCT00635700|Primary|Conversion to Psychosis|Conversion to psychosis according to the SIPS require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.|6 months|In another case assigned to active ziprasidone, ratings conducted at a follow-up conversion visit suggested retrospectively that the patient had been already psychotic prior to enrollment. The study’s blinded DSMB was consulted, and in a split 4-2 vote recommended retaining the patient as randomized in the primary analysis.|||participants|||Number
1233190|NCT00635661|Primary|Stroke Rehabilitation Assessment of Movement (STREAM)|The STREAM measures quality of movements in the arm and leg, and the quality of mobility during important functional tasks, such as walking 10 feet. There are 10 items for each of the 3 assessments (arm, leg and mobility), resulting in a total of 30 items. Each item is rated on a scale of 0 = unable to perform, to 2 or 3 = normal movement. Ratings on the 30 items are added together for a total score which is divided by the total number of items resulting in a percentage score: minimum=0, maximum=100, range=100 The score reported is mean +/- standard deviation of discharge STREAM scores.|4 weeks|34 participants were enrolled, 4 participants were dropped from the study resulting in 30 participants providing data for analysis.|||units on a scale||Standard Deviation|Mean
1233191|NCT00635648|Secondary|Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis|"Efficacy response for esophageal candidiasis was based on clinical and endoscopic criteria; favorable responses included complete and partial improvement in symptoms and endoscopic lesions.~Efficacy response for invasive candidiasis was based on microbiological and clinical assessments; favorable responses required both favorable microbiological response (i.e., eradication or presumptive eradication based on symptoms, physical exam, and non-invasive tests) and complete or partial clinical response."|First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|Of the 63 enrolled participants, one participant with invasive candidiasis who withdrew consent before completing the efficacy assessment was not included in the efficacy analyses.|||Participants|||Number
1233192|NCT00635648|Secondary|Number of Participants Who Discontinued Due to a Drug-related Adverse Event|A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)||||Participants|||Number
1233193|NCT00635648|Secondary|Number of Participants With One or More Drug-related Adverse Events|A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)||||Participants|||Number
1233194|NCT00635648|Primary|Number of Participants With One or More Drug-related Serious Adverse Events|"A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention.~A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile."|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)||||Participants|||Number
1233195|NCT00635609|Primary|Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks|Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.|baseline and 12 weeks|intention to treat (ITT)|||acne lesion count||Standard Deviation|Mean
1233196|NCT00635609|Secondary|Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks|Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.|baseline and 12 weeks||||Acne lesion count||Standard Deviation|Mean
1233197|NCT00635609|Primary|Successful Outcome According to Investigator's Global Assessment (IGA)|The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.|baseline and 12 weeks||||participants|||Number
1233202|NCT00635492|Secondary|Percentage of Patients Hospitalized Between Baseline and 24 Months|Percentage of Patients Hospitalized Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
1233203|NCT00635492|Secondary|Number of Contacts With Health Care Providers Between Baseline and 24 Months|Number of contacts with Health Care Providers Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||number of contacts||Standard Deviation|Mean
1233204|NCT00635492|Secondary|Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months|Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
1233205|NCT00635492|Secondary|Factors Associated With Treatment Change in Exenatide BID Cohort|Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||hazard ratio||95% Confidence Interval|Number
1233206|NCT00635492|Secondary|Factors Associated With Treatment Change in Insulin Cohort|Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||hazard ratio||95% Confidence Interval|Number
1233207|NCT00635492|Secondary|Reasons for Discontinuation of Baseline Regimen|Reasons for Discontinuation of Baseline Regimen|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||number of patients|||Number
1233208|NCT00635492|Secondary|Incidence of Hypoglycemia Between Baseline and 24 Months|Incidence of Hypoglycemia between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
1233209|NCT00635492|Secondary|Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months|Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
1233210|NCT00635492|Secondary|Changes in Weight From Baseline to Month 24|Changes in Weight From Baseline to Month 24|Baseline, Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||kg||Standard Deviation|Mean
1233211|NCT00635492|Secondary|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.|Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
1233212|NCT00635492|Secondary|Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24|Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis|Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
1233213|NCT00635492|Secondary|Changes in HbA1c From Baseline to Month 24|Changes in HbA1c From Baseline to Month 24|Baseline, Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of total hemoglobin||Standard Deviation|Mean
1233238|NCT00635349|Secondary|Number of Participants With Pain Relief|Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved.|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||participants|||Number
1233214|NCT00635492|Secondary|Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline|Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||mmol/L||Standard Deviation|Mean
1233215|NCT00635492|Secondary|Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline|Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||participants|||Number
1233216|NCT00635492|Secondary|Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline|Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|4 weeks prior to Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||tests/week||Standard Deviation|Mean
1233217|NCT00635492|Secondary|Higher Random Glucose Associated With Treatment Choice at Baseline|Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|6 months prior to Baseline||||mmol/L||Standard Deviation|Mean
1233218|NCT00635492|Secondary|Disinhibited Eating Associated With Treatment Choice at Baseline|Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, provided the specific data (DHP-18 subscale on disinhibited eating) and had a start date provided were included in the analyses.|||units on a scale||Standard Deviation|Mean
1233219|NCT00635492|Secondary|Older Age Associated With Treatment Choice at Baseline|Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||years||Standard Deviation|Mean
1233220|NCT00635492|Secondary|Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline|Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||percent of hemoglobin||Standard Deviation|Mean
1233221|NCT00635492|Secondary|Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline|Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||kg/m^2||Standard Deviation|Mean
1233239|NCT00635349|Secondary|Change From Day 29 in Pain Intensity Score at Day 85|Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine.|Day 29 and Day 85|Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1233286|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|Baseline||||units on a scale||Standard Deviation|Mean
1233222|NCT00635492|Primary|Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.|"The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.~Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.~Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:~Insulin:~Addition of a new medication for the treatment of type 2 diabetes~A change in the number of times insulin is administered per day~Discontinuation of any insulin initiated at baseline~Substitution of a human insulin for an analogue insulin or vice-versa.~Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.~Exenatide:~Addition of a new medication for the treatment of type 2 diabetes~Discontinuation of exenatide."|Month 24|All patients who provided consent to release information and who fulfil the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.|||probability (%)||95% Confidence Interval|Number
1233223|NCT00635479|Primary|Number of Participants With Wound Infections||Until wound healed, up to 1 year||||participants|||Number
1233224|NCT00635427|Secondary|Percentage Change From Baseline to 24 Months in Normalized Spleen Volume for Each Treatment Group||Baseline to 24 months||||Precent (%) change||95% Confidence Interval|Mean
1233225|NCT00635427|Secondary|Change From Baseline to 24 Months in Normalized Liver Volume for Each Treatment Group||Baseline to 24 months||||% Body weight||95% Confidence Interval|Mean
1233226|NCT00635427|Secondary|Change From Baseline to 24 Months in Platelet Counts for Each Treatment Group||Baseline to 24 months||||(10^9/L)||95% Confidence Interval|Mean
1233227|NCT00635427|Secondary|Change From Baseline to 24 Months in Hemoglobin Concentration for Each Treatment Group||Baseline to 24 months||||(g/dL)||95% Confidence Interval|Mean
1233228|NCT00635427|Primary|Overall Summary of Treatment Emergent Adverse Events|Safety was evaluated by an analysis of adverse events (AEs), concomitant medication use, clinical laboratory tests, vital signs during the infusion of study drug, physical examination, and the development of anti-velaglucerase alfa. No formal comparisons or statistical tests were applied for the safety analyses, including for differences between the groups.|Baseline to termination of study|All participants who received at least 1 infusion (full or partial) of study drug were evaluated for safety (ie, were included in the safety population). There were 95 participants in the safety population.|||Participants|||Number
1233229|NCT00635362|Secondary|Satisfaction With LNG-IUS|"We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being “very unsatisfied,” 2 “unsatisfied”, 3 “neutral,” 4 “satisfied,” and 5 “very satisfied.” For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question."|12 months after cesarean delivery|Analysis only done on subjects completing 12-month visit|||participants|||Number
1233230|NCT00635362|Secondary|Satisfaction With LNG-IUS|"We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being “very unsatisfied,” 2 “unsatisfied”, 3 “neutral,” 4 “satisfied,” and 5 “very satisfied.” For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question."|6 months after cesarean delivery|Analysis only done on subject completing six-month visit|||participants|||Number
1233231|NCT00635362|Secondary|Perforation Rates||12 months after cesarean delivery||||participants|||Number
1233232|NCT00635362|Secondary|Rates of Expulsion of the LNG-IUS||12 months after cesarean delivery||||participants|||Number
1233233|NCT00635362|Primary|Use of the LNG-IUS for Contraception||12 months after cesarean delivery||||participants|||Number
1233234|NCT00635349|Secondary|Number of Participants With Categorical Tenderness|Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw.|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||participants|||Number
1233235|NCT00635349|Secondary|Number of Participants With Categorical Swelling|Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC).|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||participants|||Number
1233236|NCT00635349|Secondary|Number of Participants With Overall Assessment on Study Drug by Investigator|Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.|Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure|||participants|||Number
1233237|NCT00635349|Secondary|Number of Participants With Overall Assessment on Study Drug by Participants|Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.|Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure|||participants|||Number
1233255|NCT00635167|Secondary|Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer||1 year|This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.||||||
1233256|NCT00635167|Primary|Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment||1 year|This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.||||||
1233240|NCT00635349|Primary|Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85|The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.|Day 29 and Day 85|Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied.|||units on a scale||Standard Deviation|Mean
1233241|NCT00635232|Secondary|The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.||12 weeks|Full analysis set (LOCF)|||participants|||Number
1233242|NCT00635232|Secondary|Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.||12 weeks||||mm Hg||Standard Deviation|Mean
1233243|NCT00635232|Primary|Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.||12 weeks|The primary efficacy population was the Full Analysys Set (FAS) population= all randomized subjects who took at least one dose of the assigned study drug and had both baseline and post-baseline mean seated SBP. Both LOCF and observed-data set approach were performed.|||mm Hg||Standard Deviation|Mean
1233244|NCT00635219|Secondary|Change From Baseline in ASEX Total Score After 8 Weeks of Treatment|The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient’s recent sexual experience. Patients are asked to assess their own experience over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1233245|NCT00635219|Secondary|Change From Baseline in CGI-S Score After 8 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1233246|NCT00635219|Secondary|Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1233247|NCT00635219|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS; LOCF; Logistic Regression|||percentage of patients|||Number
1233248|NCT00635219|Secondary|Change From Baseline in SDS Total Score After 8 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 8|SDS is a patient-reported outcome. The SDS Total Score is the sum of work, social life, or leisure activities, and home life or family responsibilities. FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1233249|NCT00635219|Secondary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20||Baseline and Week 8|Patients With Baseline HAM-A Total Score >=20: FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1233250|NCT00635219|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1233251|NCT00635219|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 8|FAS; LOCF; Logistic Regression|||percentage of patients|||Number
1233252|NCT00635219|Secondary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1233253|NCT00635219|Primary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)|||units on a scale||Standard Error|Mean
1233254|NCT00635167|Secondary|Patient Tolerance of TRUS Evaluation During/After Radiation Treatment||1 year|This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.||||||
1233257|NCT00635154|Secondary|Duration of Response|Duration of response is defined for all evaluable participants (receiving Anakinra alone or in combination with Dexamethasone) who have achieved an objective response as the date at which the participants status was first noted to be MR or better to the date progression is documented or the date of last follow-up.|From first documentation of response to progression or last follow-up (up to 5 years)|Participants (receiving Anakinra alone or in combination with Dexamethasone) who achieved a MR or better were analyzed.|||months||95% Confidence Interval|Median
1233258|NCT00635154|Secondary|Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone|Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.|every cycle during treatment (up to 5 years)|Only participants who received Anakinra with low or high dose dexamethasone were analyzed.|||participants|||Number
1233259|NCT00635154|Secondary|Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone|"PFS was defined as the time from registration to progression or death due to any cause.~Progression is defined the same as outcome measure #3."|Time from registration to progression or death (up to 5 years)|PFS results were published in Mayo Clin Proc, Feb 2009. 47 patients were analyzed for this publication.|||months||95% Confidence Interval|Median
1233260|NCT00635154|Secondary|Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone.|Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.|Duration of treatment (up to 5 years)||||participants|||Number
1233261|NCT00635154|Secondary|Number of Patients Who Are Progression-free and Alive at 6 Months|"Disease stability was assessed by evaluating the proportion of participants who are progression free (and alive) at 6 months.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response:~Serum M-component (absolute increase >=1.0 g/dL)~Urine M-component (absolute increase >=200 mg/24 hours)~An increase of 50% above the lowest remission value in bone marrow plasmacytosis (absolute increase 25% bone marrow plasma cells)~Development of new bone lesions or soft tissue plasmacytomas."|at 6 months||||participants|||Number
1233262|NCT00635154|Secondary|Number of Patients With Response to Treatment With Dexamethasone and Anakinra|"Response on 2 consecutive months during active treatment with anakinra alone or in combination with dexamethasone.~Response criteria is the same as in Primary Outcome Measure."|During Active treatment (up to 5 years)|Only participants who received Anakinra with dexamethasone were analyzed.|||participants|||Number
1233263|NCT00635154|Primary|Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone|"Response Definitions:~Complete Response(CR):disappearance of M-Protein from serum & urine and immunofixation, <5% bone marrow(BM) plasma cells & disappearance of soft tissue plasmacytomas(STP);~Very Good Partial Response(VGPR):>=90% decrease in serum M-Protein, Urine M-protein <100 mg/24 hours, <=5% BM plasma cells, disappearance of STP;~Partial response(PR):>=50% reduction in serum M-protein, >=90% decrease in Urine M-protein or <200 mg/24 hours & >=50% decrease in STP;~Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein & 25-49% decrease in STP"|6 months|Participants who met the eligibility criteria, signed the consent form and have began treatment were considered evaluable.|||participants|||Number
1233264|NCT00635128|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire booster period (Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1233265|NCT00635128|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|AEs results are presented for all subjects. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0–30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1233266|NCT00635128|Secondary|Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN|Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).|One month after booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1233267|NCT00635128|Secondary|Anti-Polio 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Titers||95% Confidence Interval|Geometric Mean
1233282|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|120 minutes||||units on a scale||Standard Deviation|Mean
1233268|NCT00635128|Secondary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens|A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1233269|NCT00635128|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1233270|NCT00635128|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1233271|NCT00635128|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1233272|NCT00635128|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids|Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1233273|NCT00635128|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0–3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
1233274|NCT00635128|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1233275|NCT00635128|Primary|Number of Subjects With Any Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1233276|NCT00635102|Secondary|Hopkins Verbal Learning Task - Delay Recall - 90 Minutes|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (delay recall - 30 minutes after Trials 1-3 were given) (0 No words recalled - 12 all words recalled)|90 minutes||||units on a scale||Standard Deviation|Mean
1233277|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 3|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 3||||units on a scale||Standard Deviation|Mean
1233278|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 2|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 2||||units on a scale||Standard Deviation|Mean
1233279|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 1|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 1||||units on a scale||Standard Deviation|Mean
1233280|NCT00635102|Secondary|Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes|gordon diagnostic system is a continuous performance task (CPT) to measure Vigilance - (A-Prime score range 0 minimum - 1 maximum - The higher number the better the performance)|30 minutes||||units on a scale||Standard Deviation|Mean
1233281|NCT00635102|Secondary|Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes|gordon diagnostic system is a continuous performance task (CPT) to measure distractibility - (A-Prime score range 0 minimum - 1 maximum - the higher number the better the performance)|30 minutes||||units on a scale||Standard Deviation|Mean
1233287|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|120 minutes||||units on a scale||Standard Deviation|Mean
1233288|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|60 minutes||||units on a scale||Standard Deviation|Mean
1233289|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|30 minutes||||units on a scale||Standard Deviation|Mean
1233290|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
1233291|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|Baseline||||units on a scale||Standard Deviation|Mean
1233292|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|120 minutes||||units on a scale||Standard Deviation|Mean
1233293|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|60 minutes||||units on a scale||Standard Deviation|Mean
1233294|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|30 minutes||||units on a scale||Standard Deviation|Mean
1233295|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
1233296|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|Baseline||||units on a scale||Standard Deviation|Mean
1233297|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|120 minutes||||units on a scale||Standard Deviation|Mean
1233298|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|60 minutes||||units on a scale||Standard Deviation|Mean
1233299|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|30 minutes||||units on a scale||Standard Deviation|Mean
1233300|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
1233301|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|Baseline||||units on a scale||Standard Deviation|Mean
1233302|NCT00635102|Secondary|Visual Analog Scales (VAS) - 120 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|120 minutes||||units on a scale||Standard Deviation|Mean
1233303|NCT00635102|Secondary|Visual Analog Scales (VAS) - 60 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|60 minutes||||units on a scale||Standard Deviation|Mean
1233304|NCT00635102|Secondary|Visual Analog Scales (VAS) - 30 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|30 minutes||||units on a scale||Standard Deviation|Mean
1233305|NCT00635102|Secondary|Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
1233306|NCT00635102|Secondary|Visual Analog Scales (VAS) - Baseline|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|Baseline||||units on a scale||Standard Deviation|Mean
1233307|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|120 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
1233308|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|60 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
1233309|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|30 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
1233310|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|60 minutes prior to Glycine infusion|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
1233311|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|Baseline|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
1233312|NCT00635102|Secondary|Number of Drinks Felt Consumed at 120 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|120 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|||Number of Drinks Felt Consumed||Standard Deviation|Mean
1233313|NCT00635102|Secondary|Number of Drinks Felt Consumed at 60 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|60 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|||Number of Drinks Felt Consumed||Standard Deviation|Mean
1233314|NCT00635102|Secondary|Number of Drinks Felt Consumed at 30 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|30 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|||Number of Drinks Felt Consumed||Standard Deviation|Mean
1233315|NCT00635102|Secondary|Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|60 minutes prior to Glycine infusion|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|||drinks felt consumed||Standard Deviation|Mean
1233316|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 120 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|120 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
1233317|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 60 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
1233318|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 30 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|30 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
1233319|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes prior to Glycine infusion|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
1233320|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol - Baseline|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
1233321|NCT00635089|Secondary|Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA)|Using a validated enzyme-linked immunosorbent assay (ELISA), the number of participants who had at least 1 confirmed positive value for ADA, either on day 0 after having received reslizumab in the double-blind study Res-05-0002 (NCT00538434) or during the course of the open-label study.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|Participants with an assessment.|||participants|||Number
1233322|NCT00635089|Secondary|Reslizumab Serum Concentrations|Reslizumab serum concentrations obtained in this study were included in ongoing and separate population pharmacokinetic analyses. The Number of Participants Analyzed reflects the number of participants who had concentrations measured following that dose level. Since some participants started on 1 mg/kg and later increased to 2 mg/kg (and are therefore represented in more than one column), the number of participants in each column add up to a greater number than the total in the overall column, which reflects the total number of participants with measurable concentration data in this study. The number of concentrations summarized for that dose level represents more than one concentration per participant in most cases.|Before treatment (within 3 hours) and after treatment (within 3 hours after end of infusion) for doses at Weeks 8 and 12; within 6 days after either dose at Weeks 8 or 12; 2 to 4 weeks after dose at Weeks 8 or 12; and at premature withdrawal.|Number of participants with measurable concentration data at each dose level and overall.|||µg/mL|Concentrations|Standard Deviation|Mean
1233578|NCT00633087|Primary|To Determine the Biochemical Response of This Regimen in Patients With HRPC|A PSA response is defined as a PSA decrease of 50% from baseline maintained for at least 28 days.|5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
1233323|NCT00635089|Secondary|Dietary Question Responses at Endpoint|Number of participants answering that they either maintained or changed their diet from the beginning of the double-blind study (ie, NCT00538434). Additionally, for those participants who answered that they changed their diet from the beginning of the double-blind study (column 2), the number of participants in that group who changed by increasing the consistency of their food ('Increased consistency') and the percentage that changed by eating foods that previously worsened EoE ('Added foods'). (Note that these 2 categories are not mutually exclusive, so that someone could have both increased the consistency of the food they were eating AND also eaten foods that previously worsened their EoE symptoms.)|Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)|Number of Participants Analyzed=all participants (n=190). The denominator for follow-up questions is the number of participants responding ‘No’ to the question “Have you maintained your diet since the beginning of the study?” (n=63).|||participants|||Number
1233324|NCT00635089|Secondary|Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores|The Child Health Questionnaire comprises 50 items. Specific items are recoded and/or recalibrated. Raw scores for scales (domains calculated over one or more items) are then calculated following set algorithms. The raw scales are then transformed to 0 to 100 scores, except for Change in Health which remains a 1-5 score. Finally two summary measures are calculated based on weighted combinations of selected scales. The Global Health, Physical Summary Score and Psychosocial Summary Score were summarized. For each, scores range from 0 (higher disease activity) to 100 (lower disease activity); higher scores indicate better health.|Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months)|n=participants with an assessment for the given score at Baseline and Endpoint.|||units on a scale||Standard Deviation|Mean
1233325|NCT00635089|Secondary|Physician's EoE Global Assessment Over Time|The data from the participant’s/parent’s EoE Symptom Assessment, in combination with other observations, were used by physicians to determine the Physician’s EoE Global Assessment. All components of the patient’s EoE Symptom Assessment were used by physicians to determine the Physician’s EoE Global Assessment.|Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)|The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized.||||||
1233326|NCT00635089|Secondary|Participant's EoE Predominant Symptoms Over Time|The data from the patient’s/parent’s eosinophilic esophagitis (EoE) Symptom Assessment were used to assess the shift from baseline in Predominant Symptom Assessment. The predominant symptom of the participant’s/parent’s EoE Symptom Assessment was selected at the double-blind baseline visit and remained the same throughout this study. Using the EoE Symptom Assessment, the participant/parent or legal guardian rated the severity of the previous week’s EoE symptoms as none, mild, moderate, severe, or very severe on a 5-point scale. Only the predominant symptom selected for each participant contributed to the overall analysis of the Predominant Symptom Assessment and the subgroup analyses of individual symptoms. Thus, for the Predominant Symptom Analysis, some patients had dysphagia assessed, while others had either abdominal/chest pain or vomiting/regurgitation assessed.|Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)|The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized.||||||
1233327|NCT00635089|Primary|Therapeutic Classification of Concomitant Medications in at Least 10% of Participants|Number of participants receiving therapeutic classes of concomitant medications.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)||||participants|||Number
1233328|NCT00635089|Primary|Infusion Site Evaluations|The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.|Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months)|Number of Participants Analyzed= all participants in study (n=190); n=number of participants graded at given time point.|||participants|||Number
1233329|NCT00635089|Primary|Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint|HEENT=head, eyes, ears, nose and throat.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)||||participants|||Number
1233330|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value|Low systolic blood pressure: < 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: > 160 and increase (↑) of 30 mm Hg from BL (age 5-12), > 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: < 45 and ↓ of 12 mm Hg from BL (age 5-12), < 55 and ↓ of 12 mm Hg from BL (age 13-18), < 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: > 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: < 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), < 60 and and ↓ of 30 bpm from BL (age 13-18), < 50 and and ↓ of 15 bpm from BL (age > 18); high heart rate: > 120 and ↑ of 30 bpm from BL (age 5-12), > 100 and ↑ of 30 bpm from BL (age 13-18), > 100 and ↑ of 15 bpm from BL (age > 18). Low oral body temperature: < 35.8° Celsius (age 5 to >18); high oral body temperature: > 38.1° C and ↑ 2° Celsius from BL (age 5-18).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)||||participants|||Number
1233352|NCT00634933|Secondary|General Health Visual Analog Scale (VAS)|"100 mm line (VAS) marked by participant. Participants were asked, How do you feel concerning your arthritis? Total possible score range, 0 mm = very well to 100 mm = extremely bad."|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
1233331|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality|Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose [nonfasting], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)||||participants|||Number
1233332|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value|Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes [neutrophils], lymphocytes, eosinophils, monocytes, basophils, platelets).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|Participants with a postbaseline result for hematology tests.|||participants|||Number
1233333|NCT00635089|Secondary|Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts|The mean change from baseline in esophageal eosinophil levels was described at week 16 or early withdrawal (if before week 16), using descriptive statistics. Baseline was defined as the last assessment before the first dose of reslizumab, which was the baseline of the double-blind study (NCT00538434) for patients who received reslizumab in the double blind study or the baseline of the open-label study for patients who received placebo during the double-blind study.|Baseline, Week 16 or early withdrawal (if before Week 16)|Participants with an assessment at Baseline and Week 16 (or early withdrawal).|||eosinophils/high power field (hpf)||Standard Deviation|Mean
1233334|NCT00635089|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs|An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events.|From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months)|Three additional participants experiences anaphylactic reactions that were upgraded to serious AEs after database lock. These 3 participants are not included in this table summary.|||participants|||Number
1233335|NCT00635050|Secondary|Assess Toxicities of Regimen Including Hand Foot Syndrome|patients who receive any treatment drugs will be included for toxicity evaluation. Adverse events will be summarized with frequencies and proportions of study participants exhibiting adverse events. The severity of adverse events (none, mild, moderate, severe) and their relationship to the product will be presented.|Baseline, every 2 weeks during treatment, and at completion of therapy. Every 3 weeks during postoperative Avastin||||participants|||Number
1233336|NCT00635050|Secondary|Calculate Progression Free Survival|Progression free survival (PFS) will be defined as survival without local recurrence of breast cancer and without the development of distant metastasis. Death from any cause will be included as an event. The Kaplan-Meier nonparametric method will be used to estimate progression free survival.|5 years|operative specimens after treatment of participants|||participants|||Number
1233337|NCT00635050|Secondary|Number of Participant With Clinical or Subclinical Cardiotoxicity|Left ventricular ejection fraction (LVEF) measurements and clinical examination at baseline and at end of therapy will be used.|Prior to treatment and at completion of chemotherapy||||participants|||Number
1233338|NCT00635050|Primary|Rate of Achievement of Pathological Complete Response (pCR)|Results of the pathologic evaluation of the surgical specimen(s) from operation (segmental or total mastectomy) will be used to report the overall complete pathological response rate. Criteria used were those described by Kaufmann et al, Journal of Clinical Oncology 2003; 21(13):2600-2608. The definition of pCR used from this source was absence of invasive cancer in both resected breast tissue and in resected axillary nodes.|After completion of at least 8 of the 9 chemotherapy doses and operation.|Intention to treat, i.e., all participants entered were included in the analysis.|||pathology specimens from participants|||Number
1233339|NCT00635024|Secondary|Number of Participants With Severe Non-hematological Adverse Events|Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0)|every month during treatment, up to 12 months||||participants|||Number
1233340|NCT00635024|Secondary|Duration of Response (DOR)|DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.|up to 2 years|All patients are non-evaluable - no patients responded to treatment.||||||
1233341|NCT00635024|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~Bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|up to 2 years||||months||95% Confidence Interval|Median
1233342|NCT00635024|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause.|up to 2 years||||months||95% Confidence Interval|Median
1233353|NCT00634933|Secondary|Patient Global Assessment (PtGA) of Disease Activity|Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||units on a scale||Standard Deviation|Mean
1233343|NCT00635024|Primary|Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response|"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.~Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|4 months|One participant was evaluable for the primary endpoint.|||participants|||Number
1233344|NCT00634933|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||percentage of participants|||Number
1233345|NCT00634933|Secondary|Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score|WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
1233346|NCT00634933|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
1233347|NCT00634933|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
1233348|NCT00634933|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
1233349|NCT00634933|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
1233350|NCT00634933|Secondary|Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||units on a scale||Standard Deviation|Mean
1233351|NCT00634933|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||units on a scale||Standard Deviation|Mean
1233407|NCT00634569|Secondary|Other Infections Documented by Fever and Physical Exam or Positive Radiograph.||12 months||||Number of other infections||Standard Deviation|Mean
1233408|NCT00634569|Secondary|Number of Visits to Physician/ER Room for Acute Problems|Mean Number of visits to physician/ER room for acute problems|12 months||||Visits||Standard Deviation|Mean
1233354|NCT00634933|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||units on a scale||Standard Deviation|Mean
1233355|NCT00634933|Secondary|Visual Analogue Scale for Pain (VAS-pain)|100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||mm||Standard Deviation|Mean
1233356|NCT00634933|Secondary|Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
1233357|NCT00634933|Secondary|Number of Swollen Joints|The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||swollen joints||Standard Deviation|Mean
1233358|NCT00634933|Secondary|Number of Tender Joints|The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||tender joints||Standard Deviation|Mean
1233359|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||percentage of participants|||Number
1233360|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 20 were not analyzed because of early termination of the study.|||percentage of participants|||Number
1233361|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||percentage of participants|||Number
1233362|NCT00634933|Primary|Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Week 24|Modified intent-to-treat (mITT) population included all randomized participants who received any portion of test article. Last observation carried forward (LOCF) method was used to impute missing values.|||percentage of participants|||Number
1233363|NCT00634920|Secondary|Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D|Health-related QoL was assessed using the EQ-5D questionnaire. The EQ-5D self-report questionnaire consists of the EQ-5D descriptive system that measures health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/moderate problems/severe problems) within a particular EQ-5D dimension. Scores are transformed to a range of 0-1, in which higher scores reflect better health status.|Before randomization, Months 12, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||scores on a scale||Standard Deviation|Mean
1233409|NCT00634569|Secondary|Days of Hospitalization Per Year|Mean Days of hospitalization per subject/year|12 months||||Days||Standard Deviation|Mean
1233364|NCT00634920|Secondary|Percentage of Participants Who Had Donor Specific Antibodies (DSA)|Venous blood was drawn for donor specific (DSA) measurements prior to transplantation and at the final visit (36 months). The blood sample was first screened for the presence of PRA i.e. donor specific Immunoglobulin-G antibodies against specific HLA antigens. If PRA antibodies were detected, the blood sample was tested for specific DSAs on single antigen Luminex beads (coated with single HLA class I or II molecules). In this way, the specificity of these antibodies could be determined.|Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
1233365|NCT00634920|Secondary|Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))|Proteinuria is when a large amount of protein, that should remain circulating in a person’s blood, is “spilled” into their urine and eliminated from the body.|Months 12, 24, 36|The safety population (SAF) consists of all patients in whom TX was performed and who were randomized and treated with at least one dose of randomized treatment.|||mg/mmol||Standard Deviation|Mean
1233366|NCT00634920|Secondary|Percentage of Participants on Antihypertensive Drugs||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
1233367|NCT00634920|Secondary|Number of Antihypertensive Drugs Taken||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Number of antihypertensive dugs||Standard Deviation|Mean
1233368|NCT00634920|Secondary|Percentage of Participants on Lipid-lowering Drugs||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
1233369|NCT00634920|Secondary|Number of Lipid-lowering Drugs Taken||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Number of lipid-lowering drugs||Standard Deviation|Mean
1233370|NCT00634920|Secondary|Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides|Blood lipid levels of patients in both groups: HDL-C, LDL-C,Total cholesterol, and triglycerides.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||mmol/L||Standard Deviation|Mean
1233371|NCT00634920|Secondary|Lipid Profile for Apolipoprotein|Blood lipid levels of patients in both groups for Apolipoprotein (Apo) A1 and B.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||g/L||Standard Deviation|Mean
1233372|NCT00634920|Secondary|Time to First Malignancy|This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Months||Standard Error|Mean
1233373|NCT00634920|Secondary|Percentage of Participants With Treatment Failures|Treatment failure was defined as graft loss or death.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
1233374|NCT00634920|Secondary|Time to Treatment Failure|Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Days||Standard Error|Mean
1233375|NCT00634920|Secondary|Percentage of Participants With Graft Loss or Death|The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event).|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
1233376|NCT00634920|Secondary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)|A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
1233410|NCT00634569|Secondary|Days of School/Usual Activities Missed Per Year|Mean Days of school/usual activities missed per subject/year|12 months||||Days||Standard Deviation|Mean
1233411|NCT00634569|Primary|Serious Bacterial Infections.|Total number of Bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis|12 months||||Total serious bacterial infections|||Number
1233377|NCT00634920|Secondary|Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)|Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space)|Month 12, Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
1233378|NCT00634920|Secondary|Progression of Measured Glomerular Filtration Rate|Change in renal progression measured by mean mGFR from week 7 to Month 36|Week 7, Week 52, Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||mL/min/1.73m^2||Standard Deviation|Mean
1233379|NCT00634920|Secondary|Calculated Glomerular Filtration Rate|The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points.|Months 12, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||mL/min/1.73m^2||Standard Deviation|Mean
1233380|NCT00634920|Secondary|Measured Glomerular Filtration Rate|Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.|Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). Patients who did not provide mGFR assessment at M36 visit were excluded from the analysis.|||mL/min/1.73m^2||Standard Deviation|Mean
1233381|NCT00634920|Primary|Measured Glomerular Filtration Rate|To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.|Month 12|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||mL/min/1.73m^2||Standard Deviation|Mean
1233382|NCT00634907|Post-Hoc|Mean Number of Doses Before the First Supratherapeutic INR|The number of warfarin doses administered before a patient INR exceeded the therapeutic range (>2.9) was recorded. The average was then calculated and is shown here.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||doses administered||Standard Deviation|Mean
1233383|NCT00634907|Post-Hoc|Mean Number of Doses Required for the First Therapeutic INR|The number of doses required to achieve a therapeutic INR (1.8-2.9) was determined per patient, per arm. The average was then calculated and is shown here.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||doses||Standard Deviation|Mean
1233384|NCT00634907|Post-Hoc|Percent of Patients With Dose Adjustments|The percent of patients that required a dose adjustment during the study period was calculated.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||percentage of patients|||Number
1233385|NCT00634907|Post-Hoc|Mean Number of Dose Adjustments|The average number of dose adjustments made per patient, per arm, during the study period was calculated|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||doses||Standard Deviation|Mean
1233386|NCT00634907|Post-Hoc|Mean Number of Doses Before First Dose Adjustment|The number of consistent doses administered before the first dose adjustment was required was recorded, per patient. The average number of doses administered before the first dose adjustment is shown.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||doses||Standard Deviation|Mean
1233387|NCT00634907|Secondary|Percentage of Determinations Supratherapeutic (INR>2.9)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was greater than 2.9, the patient was considered to be supratherapeutic. The proportion of INR determinations that were supratherapeutic was calculated, per arm, based on total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm|||percentage of determinations|||Number
1233388|NCT00634907|Secondary|Percentage of Determinations Subtherapeutic (INR<1.8)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was less than 1.8, the patient was considered to be subtherapeutic. The proportion of INR determination that were subtherapeutic was caluculated, per arm, based on the total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hop arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm|||percentage of deteminations|||Number
1233389|NCT00634907|Secondary|Percentage of Determinations in Therapuetic Range (INR 1.8-2.9)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was between 1.8 and 2.9, the patient was considered to be therapeutic. The proportion of INR determinations that fell within the therapeutic range (INR between 1.8-2.9) was calculated, per arm, based on total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm|||percentage of therapeutic INR values|||Number
1233390|NCT00634907|Primary|The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement|"Adverse events were defined as~Major bleeding: fatal bleeding, bleeding into a critical organ, bleeding that requires hospital admission~Minor bleeding: clinically overt bleeding not meeting criteria for major bleeding~Symptomatic deep vein thrombosis (DVT)~Pulmonary embolism (PE)"|90 days post surgery||||participants|||Number
1233391|NCT00634842|Secondary|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)|"Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:~If subject was unable to treat himself: Major incidence.~If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.~If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only."|weeks 0-20|The safety population consists of all subjects exposed to study drug.|||number of events|||Number
1233392|NCT00634842|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline|Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20|week -2, week 20|The intent-to-treat (ITT), LOCF (last observation carried forward) population. One Subject in 70-90 group, however, had a missing baseline value, therefore, no change from baseline could be calculated.|||percentage point change||Standard Error|Least Squares Mean
1233393|NCT00634842|Secondary|Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%|Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment|week 20|The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)|||percentage of participants|||Number
1233394|NCT00634842|Primary|Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%|Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment|week 20|The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)|||percentage of participants|||Number
1233395|NCT00634751|Secondary|Overall Survival|Overall survival, defined as number of days from the day of first study drug administration to the day the patient dies, summarized using point estimates of the median time to progression, and associated 95% confidence intervals|Up to 18 months|Overall survival was not a pre-specified Phase I outcome, and no data was collected or analyzed. No data was collected for Phase II biliary tract participants.|||Months||95% Confidence Interval|Median
1233396|NCT00634751|Secondary|Progression-free Survival (PFS)|Time to progression, defined as number of days from day of first study drug administration to the day the patient experiences an event of disease progression or death; summarized using point estimates of the median time to progression and associated 95% confidence intervals for each stratum separately.|Up to 18 months|PFS was not a pre-specified Phase I outcome, and no data was collected or analyzed. No data was collected for Phase II biliary tract participants.|||Months||95% Confidence Interval|Median
1233397|NCT00634751|Primary|Overall Response Rate|Response rate of participant to treatment|Up to 18 months||||participants|||Number
1233398|NCT00634647|Secondary|Median Overall Survival (OS)|Overall Survival is the time between the first day of treatment to the day of death.|time between the first day of treatment to the day of death, approximately 15.7 months|24 pts were enrolled but only 21/24 were assessed for OS. One pt died on treatment and (e.g.3 pts were non-evaluable for analysis of response).|||Months||95% Confidence Interval|Median
1233399|NCT00634647|Secondary|Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 57 months.|The time frame for adverse events includes one year follow-up data.|||Participants|||Count of Participants
1233400|NCT00634647|Primary|Progression Free Survival.|Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|15 months|24 pts were enrolled but only 21/24 were assessed for OS. One pt died on treatment and (e.g.3 pts were non-evaluable for analysis of response).|||Months||95% Confidence Interval|Median
1233401|NCT00634621|Secondary|Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level.|The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.|Day 0 (Post contrast administration)|The number of confirmed bladder cancer was 219 identified by the standard of truth methods using the White-light cystoscopy and blue-light cystoscopy technique.|||Percentage of confirmed Lesions||95% Confidence Interval|Number
1233402|NCT00634621|Primary|Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy.|Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.|Day 0 (Post contrast administration)|Number of True-positive lesions according to histology was 621 and broken out into various tumor stages. The Tumor stage distribution of true-positive bladder tumor lesions and their detection by White-light Cystoscopy (WLC) and/or Blue-light Cystoscopy (BLC).|||Number of lesions|||Number
1233403|NCT00634582|Primary|Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer||16 weeks|This trial was closed for slow accrual. For cost reasons, analysis was to be done in a batch size never reached, so the analysis was not done.||||||
1233404|NCT00634569|Secondary|Number of Adverse Events|Total Number of Adverse Events|12 months||||All Adverse Events|||Number
1233405|NCT00634569|Secondary|Number of Days on Antibiotics (Prophylactic and Therapeutic).|Median Combined number of days on prophylactic and therapeutic antibiotics|12 months||||Days||Standard Deviation|Median
1233406|NCT00634569|Secondary|Number of Infectious Episodes Per Year|Mean Number of infectious episodes per subject/year|12 months||||Infectious episodes||Standard Deviation|Mean
1233412|NCT00634543|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 43|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health and mental health. Physical health includes physical functioning, role limitations due to physical health, pain and general health. Mantal health includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline and Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for at given time point.|||Units on a scale||Standard Deviation|Mean
1233413|NCT00634543|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43|The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Pain severity score is caculated by sum of all severity items (pain worst, pain least, pain average and pain now) divided by pain now. Total score for pain severity ranges from 0=no pain to 10=extreme pain. Pain interference score was calculated by sum of all interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) score. Total score for pain interference ranges from 0=no interference to 70= interferes completely.|Baseline and Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for this outcome measure at a particular time point.|||Units on a scale||Standard Deviation|Mean
1233414|NCT00634543|Secondary|Overall Assessment of Study Medication by Investigator|Overall assessment of study medication was done by Investigator. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.|Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here ‘N’ signifies number of participants who were evaluated for this outcome measure.|||Percentage of participants|||Number
1233415|NCT00634543|Secondary|Overall Assessment of Study Medication by Participants|Overall assessment of study medication was done by participants. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.|Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here ‘N’ signifies number of participants who were evaluated for this outcome measure.|||Percentage of participants|||Number
1233416|NCT00634543|Secondary|Percentage of Participants With Pain Relief|Pain relief was assessed on a scale ranging from -1 to 4, where -1=became worse, 0=no change, 1=relieved a little, 2=relieved moderately, 3=relieved a lot and 4=completely resolved.|Day 15, Day 29 and Day 43|FAS included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.|||Percentage of Participants|||Number
1233417|NCT00634543|Primary|Change From Baseline in Pain Intensity Score at Day 43|Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.|Baseline and Day 43|Full analysis set (FAS) included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1233418|NCT00634504|Primary|Pharmacokinetics (PK) of Leucovorin|Geometric mean 6S-leucovorin area under the curve|3 hours post LV administration||||micromol x hour/L||95% Confidence Interval|Geometric Mean
1233419|NCT00634322|Primary|Patients Progressing to Next Chemotherapy Cycle||1 week after intervention|||||||
1233420|NCT00634270|Secondary|To Evaluate the Role of Apolipoprotein E Genotypes as Predictors for Development of Hyperlipidemia During Therapy With Sirolimus.|Number of patients who experienced hyperlipidemia is being reported.|24 weeks Stratum 1 / 48 weeks Stratum 2||||participants|||Number
1233421|NCT00634270|Secondary|To Evaluate Pharmacogenetic Polymorphisms of Cytochrome P450 3A4 & 3A5 Alleles and P-glycoprotein/MDR for Their Influence on the Metabolism of Sirolimus in This Patient Population.|Trough concentration of sirolimus is reported in nanograms per mL.|24 weeks Stratum 1 Only|Subjects in Stratum 1.|||ng/mL||Standard Deviation|Mean
1233422|NCT00634270|Secondary|To Evaluate the Effect of Sirolimus on Clinical Response by Reduction in Pain, or Improvement in Function or Performance Scale.|There were no data collected for this outcome measure.|24 weeks Stratum 1 / 48 weeks Stratum 2|||||||
1233423|NCT00634270|Secondary|To Asses Preliminary Correlations of Radiographic Response With Changes in Pharmacodynamics Parameters Including p70s6 Kinase Activity in Peripheral Blood Mononuclear Cells.|Response by Volumetric MRI.|24 weeks Stratum 1 / 48 weeks Stratum 2|Samples were inadequate in quantity to allow for this analysis.||||||
1233424|NCT00634270|Secondary|To Assess the Value of Three-dimensional MRI (3-D MRI) in the Evaluation of Plexiform Neurofibromas and Paraspinal Neurofibromas, and to Compare 3-D MRI to Conventional Two-dimensional MRI (2-D MRI) and One Dimensional MRI (1-D MRI) Data Analysis|The study provided central review of all MRIs using a three-dimensional volumetric protocol. As the STOPN protocol began, research had already demonstrated the superiority of this approach to 1-D or 2-D analyses, so these were not used in the STOPN study.|24 weeks Stratum 1 / 48 weeks Stratum 2|The data for this outcome wasn't collected because prior to the study, it was determined that MRI (3-D MRI) was already superior, so the MRI was not performed on any of the participants||||||
1233436|NCT00634244|Primary|The Rate of Complete Remission (CR+CRi)|CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100 x 10^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L).|Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.|Eligible and treated|||proportion of participants||90% Confidence Interval|Number
1233425|NCT00634270|Secondary|To Evaluate the Quality of Life During Treatment With Sirolimus by Assessing Preliminary Correlations of Response With Quality-of-life Outcomes|Self-reported, age-appropriate PedsQL Scale. Assessments included: Inventory for physical function, emotional function, social function and school function - number system 0-4 was used with 4 being the worse maximum threshold); inventory for chronic illness used a 5-point likert scale - 5 being the worst maximum threshold; Skindex-Teen used a scale of 0 to 100 - the higher the number the more frequent the experience; Pain intensity was measured using a line with a happy and sad face - marks toward the sad face indicated more intense pain; and, the McGill Pain Questionnaire - higher values indicating worse pain of a scale from 0-3. All assessments were combined for an overall PedsQL score by rating each item 0-4, then reverse transforming each to a 0 - 100 scale. The total scores were calculated by averaging the item scores, with higher scores being better.|24 weeks Stratum 1 / 48 weeks Stratum 2|Stratum 1 patients with Neurofibromatosis Type 1; all ages - Change from Baseline to Course 3. Stratum 2 did not meet the requirements for response at the 6 month time point. Therefore, Stratum 2 was not analyzed for this aim.|||Units on a scale||Standard Deviation|Mean
1233426|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population - Therapeutic Dose (mg/kg)^0.75|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients (ages 3 to 18) - Therapeutic Dose (mg/kg)^0.75. Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||Therapeutic Dose (mg/kg)^0.75||Standard Deviation|Mean
1233427|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus in When Administered to This Patient Population - Therapeutic Dose (mg/kg Per Dose)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients (Ages 3 to 18) Therapeutic Dose (mg/kg per dose). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||Therapeutic Dose (mg/kg per dose)||Standard Deviation|Mean
1233428|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population- Therapeutic Dose (mg/m^2 Per Dose)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients - Therapeutic Dose (mg/m^2 per dose). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||Therapeutic Dose mg/m^2 per dose||Standard Deviation|Mean
1233429|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population - (Clearance (L/h Per 1.85 m^2)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 Patients Clearance (L/h per 1.85 m^2). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||L/h per 1.85 m^2||Standard Deviation|Mean
1233430|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population Using Liters/Hour Per Population Median Weight of 70kg (L/h70kg)|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1 used allometrically scaled clearance (clearance scaled to a 70kg individual). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||L/h/70kg||Standard Deviation|Mean
1233431|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus Administered to This Patient Population (Clearance Liters/Hour (L/h))|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Pediatric Patients (3 through 18) with Neurofibromatosis Type 1 - Clearance liters/hour (L/h). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||Clearance liters/hour (L/h)||Standard Deviation|Mean
1233432|NCT00634270|Primary|Toxicity|Number of participants experiencing adverse events|24 weeks Stratum 1 / 48 weeks Stratum 2|All evaluable participants for Stratum 1 and 2 combined.|||Participants|||Number
1233433|NCT00634270|Primary|Results in Objective Radiographic Responses Based on Volumetric MRI Measurements in Children and Adults With NF1 and Inoperable PN in the Absence of Documented Radiographic Progression at Trial Entry|Stratum 2 outcome - Response|48 weeks Stratum 2|Identify the index plexiform neurofibroma(s) for 3-D MRI evaluation based on prior imaging studies. The criteria for response was <20% increase in volume using RECIST v1.0. Response for 48 weeks was only assessed for Stratum 2.|||participants|||Number
1233434|NCT00634270|Primary|Time to Disease Progression Based on Volumetric MRI|Median time to progression in Stratum 1 as defined as an increase of at least 20% of the volume of the primary lesion. Note: Since Stratum 2 looked at response rate only, median time to progression was not reviewed for this outcome.|24 Months Stratum 1|"All evaluable participants. Note: In Stratum 2 the value was not assessed as time to progression therefore the appropriate response would be N/A. Stratum 2 was reported as response rate only."|||Months||95% Confidence Interval|Median
1233435|NCT00634244|Secondary|The Rate of Treatment Failure|"The definition of treatment failure will include:~≥ 5% leukemic blasts at the time of pre-consolidation marrow~Death during/following induction chemotherapy (pre-consolidation)~Persisting marrow hypoplasia and pancytopenia for ≥ 2 months after chemotherapy~CNS or extramedullary disease at the time of pre-consolidation~Leukemia persistence after completion of induction treatment. Leukemia persistence is defined as greater than 10% residual blasts on marrow biopsy done 5-7 days after completion of induction chemotherapy"|Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.|Eligible and treated|||proportion of participants||90% Confidence Interval|Number
1233580|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.|During a 21-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1233437|NCT00634179|Secondary|An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria|Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response.|Following completion of therapy, up to 2 years||||participants|||Number
1233438|NCT00634179|Primary|Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.|Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks||||mg/m^2||95% Confidence Interval|Number
1233439|NCT00634166|Secondary|The Secondary Objective is to Examine the Reasons for Graft Loss in Subjects Treated With Sulfamylon® Solution Versus Historical Controls.||Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14 and Days 18-21; Treatment Failure at Days 5-7; and Infectious Graft Loss at Days 5-7, Days 12-14 and Days 18-21.|||||||
1233440|NCT00634166|Primary|Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.||The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.||||Percentage of Participants|||Number
1233441|NCT00634114|Secondary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.|Up to 12 weeks||||Participants|||Number
1233442|NCT00634114|Primary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.|Up to 24 weeks||||Participants|||Number
1233443|NCT00634114|Secondary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.|up to 4 weeks||||Participants|||Number
1233444|NCT00634088|Secondary|Duration of Response of Combination Treatment With Ixabepilone Plus Lapatinib|Duration of response is measured from the time in months that measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented PD or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.|First occurrence of PR or CR to PD or Death (no average, as no data available)|Because the study was terminated due to insufficient enrollment, the duration of response could not be analyzed.||||||
1233445|NCT00634088|Secondary|Overall Tumor Response By Number of Participants|Target lesion criteria: Complete Response(CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial Response (PR)=A 30% or greater decrease in the sum of longest diameter(LD) of all lesions in reference to the baseline sum LD. Stable Disease (SD)=Insufficient increase to qualify for Progressive Disease (PD) and insufficient shrinkage to qualify for PR; PD=A 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.|Baseline and Day 21 (21-day cycle)|All participants with measurable disease at baseline per RECIST guidelines, with the exception of those with an incorrect diagnosis.|||Participants|||Number
1233446|NCT00634088|Primary|MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine|MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a DLT, with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.|Days 1 through 21|Because the study was terminated due to insufficient enrollment, no participants received the triplet combination.||||||
1233447|NCT00634088|Secondary|Volume of Distribution at Steady State of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||Liters||Standard Deviation|Mean
1233448|NCT00634088|Secondary|Time to Peak Concentration of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||Hours||Full Range|Median
1233449|NCT00634088|Secondary|Terminal Half-life of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||Hours||Standard Deviation|Mean
1233450|NCT00634088|Secondary|Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||ng*h/mL||Standard Deviation|Geometric Mean
1233451|NCT00634088|Secondary|Maximum Concentration of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||ng/mL||Standard Deviation|Geometric Mean
1233582|NCT00633074|Secondary|Duration of Solicited General Symptoms|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.|||Days||Full Range|Median
1233452|NCT00634088|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade|CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. ALT(U/L) Gr 1:>ULN–2.5*ULN,Gr 2:>2.5–5.0*ULN,Gr 3:>5.0–20.0*ULN,Gr 4:>20.0* ULN; AST(U/L) Gr 1:>ULN–2.5* ULN,Gr 2:>2.5–5.0*ULN,Gr 3:>5.0–20.0*ULN,Gr 4:>20.0* ULN; ALP(U/L)Gr 1:>ULN–2.5*ULN, Gr 2:>2.5–5.0*ULN, Gr 3:>5.0-20.0*ULN, Gr 4:>20.0*ULN; Creatinine (mg/dL): Gr 1:>ULN–1.5*ULN, Gr 2:>1.5–3.0*ULN, Gr 3:>3.0–6.0*ULN, Gr 4:>6.0*ULN; Total bilirubin (mg/dL): Gr 1:>ULN–1.5*ULN, Gr 2:>1.5–3.0*ULN, Gr 3:>3.0–10.0*ULN, Gr 4:>10.0*ULN|At baseline and within 72 hours of Day 1 of 21-day cycle|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.|||Participants|||Number
1233453|NCT00634088|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade|CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. WBC (c/L): Grade (Gr)1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC (c/uL): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count (c/uL): Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0*10^9/L; Hemoglobin (g/dL): Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|Baseline and weekly from Days 1 to 21 (Cycle 1)|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.|||Participants|||Number
1233454|NCT00634088|Secondary|Number of Participants With DLT|DLT=Any of the following events, attributable to study drug and occurring within 21 days after ixabepilone administration: Grade 3 or 4 nausea, vomiting, or diarrhea despite the use of adequate medical intervention; other Grade 3 or greater nonhematologic toxicity requiring removal from study drug; recovery from study drug-related toxicity that delayed scheduled retreatment for longer than 3 weeks; Grade 4 neutropenia for 5 or more consecutive days or Grade 3 or 4 neutropenia of any duration with sepsis or fever; thrombocytopenia or bleeding requiring platelet transfusion.|Baseline to Day 21, continuously|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.|||Participants|||Number
1233455|NCT00634088|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Treatment-related AEs, Treatment-related AEs (Grade 3 or 4), Peripheral Neuropathy (PN), PN (Grade 3 or 4)|AE=Any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, important, a congenital anomaly/birth defect; or requires or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Common Terminology Criteria (CTC) Grade 3=severe; Grade 4=life-threatening or disabling.|Baseline to Day 21, continuously|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.|||Participants|||Number
1233456|NCT00634088|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib|The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.|Days 1 through 21|Because the study was terminated due to insufficient enrollment, MTD was not achieved.||||||
1233457|NCT00634049|Secondary|Safety - Overall Number of TEAEs|A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.|From the first study drug administration until 28 days after the last dose of study drug|The safety analysis set (SAF) consists of all enrolled participants who received at least one dose of study drug as this was a non-comparative open-label study|||participants|||Number
1233458|NCT00634049|Secondary|All-cause Mortality Through Day 42 and Day 84|"All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Baseline to End of Treatment (EOT [Day 180])|Intent-To-Treat population (ITT)|||percentage of participants|||Number
1233459|NCT00634049|Secondary|Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
1233460|NCT00634049|Secondary|Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
1233461|NCT00634049|Secondary|Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
1233524|NCT00633594|Secondary|Overall Survival of Previously Treated and Previously Untreated Participants|"Defined as the date of study entry to the date of death.~Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification"|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|all participants that received study treatment|||months||95% Confidence Interval|Median
1233462|NCT00634049|Secondary|Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
1233463|NCT00634049|Secondary|Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
1233464|NCT00634049|Secondary|Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
1233465|NCT00634049|Primary|Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).|"The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
1233466|NCT00634036|Secondary|Exhaled Nitric Oxide Ppb||12 weeks||||ppb||Standard Deviation|Mean
1233467|NCT00634036|Secondary|Juniper Asthma Control Questionnaire|The Juniper Asthma Control Questionnaire is a validated scale ranging from 0 to 6. Higher scores represent poorer asthma control. Values > 1.5 are compatible with poorly controlled asthma|12 weeks||||Scores on a scale||Standard Deviation|Mean
1233468|NCT00634036|Secondary|FEV1 % Predicted||12 weeks||||% predicted||Standard Deviation|Mean
1233469|NCT00634036|Primary|Airway Reactivity|Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by > 20% from pre-methacholine baseline values.|12 weeks||||mg/ml||Inter-Quartile Range|Median
1233470|NCT00634010|Primary|Participant Pain Severity Score Measured Using Brief Pain Inventory|Brief Pain Inventory (BPI): Pain severity measured with BPI, which asks participants to rate pain for last 24 hours on 0 to 10 scales at its “worst”, “least”, “average “ and “now”. The scales are presented on a 10 cm line, with each number equidistant from the next. Each scale is bounded by the words “no pain’ at the 0 end and “pain as bad as you can imagine” at the other. BPI used to determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 4 week (+/- 3 days) treatment period in participants with advanced cancer.|Comparing baseline and pain scores at 4 weeks (+/- 3 days)|The study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups. Participants eligible for the study often had significant symptom distress and could not continue in the four week study period needed for data collection contribution to mean calculation.||||||
1233471|NCT00633984|Primary|CGI - Clinical Global Impression of Improvement|"The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global severity of symptoms. The CGI-I ranges from 1 (very much improved) to 7 (very much worse). Response and remission was defined as an improvement score of 1 (very much improved) or 2 (much improved) on the CGI-I."|Week 13||||units on a scale||95% Confidence Interval|Mean
1233472|NCT00633984|Primary|Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations occurring in the last week. Each item is rated from 0-3 for both fear and avoidance with a possible score of 144; 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, and Greater than 95 - Very severe social phobia. Remission was defined as a score of < 30 on the Liebowitz Social Anxiety Scale|Week 13||||units on a scale||95% Confidence Interval|Mean
1233473|NCT00633932|Secondary|"Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification"|Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).|4 weeks|One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.|||participants|||Number
1233525|NCT00633594|Secondary|Overall Survival of Phase I and Phase II Participants|"Defined as the date of study entry to the date of death.~Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification"|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|all participants that received study treatment|||months||95% Confidence Interval|Median
1233474|NCT00633932|Primary|"Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification."|Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).|8 weeks|One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.|||participants|||Number
1233475|NCT00633919|Secondary|Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007|"The treatment efficacy was rated by both subject and investigator at the end of the evaluation period in autumn 2007. Subjects rated their asthma symptoms in comparison to previous autumns and investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.~The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2007: All available data were used to their full extent, but no imputation of data was performed.|||Participants|||Number
1233476|NCT00633919|Secondary|Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008|"The treatment efficacy was rated by investigators at the end of the evaluation period in autumn 2008. Investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.~The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.|||Participants|||Number
1233477|NCT00633919|Secondary|Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008|"The treatment efficacy was rated by subjects at the end of the evaluation period in autumn 2008. Subjects rated their asthma symptoms in comparison to previous autumn using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.~The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.|||Participants|||Number
1233478|NCT00633919|Secondary|Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007|"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)."|8 weeks|Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2007. All available data were used to their full extent, but no imputation of data was performed.|||Scores on a scale||Standard Deviation|Mean
1233479|NCT00633919|Primary|Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008|"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)."|8 weeks|Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2008. All available data were used to their full extent, but no imputation of data was performed.|||Scores on a scale||Standard Deviation|Mean
1233480|NCT00633893|Secondary|Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation|DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 7, 4, 14 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
1233526|NCT00633594|Secondary|Progression Free Survival (PFS) of Previously Treated and Previously Untreated Participants|"Defined as the time from entry onto study until lymphoma progression or death from any cause.~Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|All participants that received study treatment|||months||95% Confidence Interval|Median
1233481|NCT00633893|Secondary|Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 10 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
1233482|NCT00633893|Secondary|Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 7 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
1233483|NCT00633893|Secondary|Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation|PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 8, 4, 15 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
1233484|NCT00633893|Secondary|Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation|DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 6, 8, 53 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1233485|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 76 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1233503|NCT00633880|Secondary|Change in Orthostatic Hypotension Symptom Scores Excluding Dizziness (OHSA Composite Items 2-6)|OHSA composite scale (items 2-6) is the average of five OHSA items: 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|"One placebo patient excluded from analysis per the SAP because all baseline values in the composite were zero.~LOCF was used to impute values for patients who did not have an end of study visit."|||units on a scale||Standard Deviation|Mean
1233486|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 73 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
1233487|NCT00633893|Secondary|Adjudicated Total Bleeding During the Treatment Period - Treated Participants|All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 94, 121, 74 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
1233488|NCT00633893|Secondary|Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants|All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 75, 98, 58 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
1233489|NCT00633893|Secondary|Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants|Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 25, 34, 19 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
1233490|NCT00633893|Secondary|Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants|Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 Months|Treated participants were those who received at least 1 dose of study drug. (n)number of events = 27, 35, 22 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.|||proportion of participants||95% Confidence Interval|Number
1233491|NCT00633893|Secondary|Adjudicated Major Bleeding During the Treatment Period - Treated Population|Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 Months|Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 2, 1, 4 in apixaban 2.5 mg, and 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
1233581|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During a 21-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1233492|NCT00633893|Secondary|Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation|All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. In first event (first primary event) each participant counted once. In event category, each participant was counted only once in each event category but could have been counted in multiple categories.|||participants|||Number
1233493|NCT00633893|Secondary|Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation|DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. (n) number of events = 22, 25, 33 in apixaban 2.5 mg, apixaban 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
1233494|NCT00633893|Secondary|Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. number of events (n)= 17, 24, 29 in the apixaban 2.5 mg, 5 mg, placebo arms, respectively.|||Proportion of Participants||95% Confidence Interval|Number
1233495|NCT00633893|Secondary|Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 17, 24, 26 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
1233496|NCT00633893|Secondary|Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation|PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 23, 25, 37 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
1233504|NCT00633880|Secondary|Change in Orthostatic Hypotension Symptom Assessment Score (OHSA Composite)|The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
1233770|NCT00631475|Secondary|Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.|Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.|up to 21 months, plus 24 hours after the end of study treatment|Study population|||participants|||Number
1233497|NCT00633893|Secondary|Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation|DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 19, 28, 72 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
1233498|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.|Day 1 up to 12 Months|Intent to treat: all randomized participants with consent.(n)number of events=27, 34, 95 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. The (n)number of imputed events were = 13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits|||proportion of participants||95% Confidence Interval|Number
1233499|NCT00633893|Primary|Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned.(n)number of events = 19, 14, 77 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. All events were counted; no events were imputed.|||Proportion of participants||95% Confidence Interval|Number
1233500|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.|Day 1 up to 12 Months|ITT: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=27, 34, 92 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. Number of imputed events=13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
1233501|NCT00633893|Primary|Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation|VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.|Day 1 up to 12 Months|Intent to treat: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=32, 34, 96 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively; number of events imputed=13, 20, 19, respectively. Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
1233502|NCT00633880|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing;|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|three placebo patients excluded from the analysis due to missing standing blood pressure values at either randomization or end of study.|||mmHg||Standard Deviation|Mean
1233771|NCT00631475|Secondary|Treatment-emergent Serious Adverse Events (SAE)|Number of participants with at least one SAE during the study.|up to 21 months plus 28 days after the end of study drug|Study population|||participants|||Number
1233505|NCT00633880|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|One placebo patient excluded from analysis because OHDAS values were not evaluable.|||units on a scale||Standard Deviation|Mean
1233506|NCT00633880|Secondary|Change in Head/Neck Discomfort (OHSA Item 6)|OHSA item 6 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
1233507|NCT00633880|Post-Hoc|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) ."|14 days|3 droxidopa patients and 2 placebo patients were excluded from the analysis due to missing randomization values.|||units on a scale||Standard Deviation|Mean
1233508|NCT00633880|Secondary|Change in Concentration (OHSA Item 5)|OHSA item 5 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
1233509|NCT00633880|Secondary|Change in Vision (OHSA Item 2)|OHSA item 2 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
1233510|NCT00633880|Secondary|Change in Weakness (OHSA Item 3)|OHSA item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
1233511|NCT00633880|Secondary|Change in Fatigue (OHSA Item 4)|OHSA item 4 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
1233512|NCT00633880|Primary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|Missing data were imputed using the last observation carry forward method.|||units on a scale||Standard Deviation|Mean
1233513|NCT00633867|Primary|Intubation Time|Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation|At intubation||||seconds||Inter-Quartile Range|Median
1233514|NCT00633867|Secondary|Incidence of Visible Trauma to the Airway||At analysis|||||||
1233515|NCT00633867|Secondary|Incidence of Low Arterial Saturation During Intubation||At analysis|||||||
1233516|NCT00633867|Secondary|Number of Intubations Taking More Than 70 Seconds||At Analysis|||||||
1233517|NCT00633867|Secondary|Incidence of Initial Oesophageal Intubation||At analysis|||||||
1233518|NCT00633867|Secondary|Number of Attempts to Secure Successful Intubation|Is there a difference in the number of attempts required to secure successful intubation ?|At analysis|||||||
1233519|NCT00633867|Secondary|Quality of View of the Vocal Cords||At analysis|||||||
1233520|NCT00633867|Secondary|Difference in Learning to Use the Scopes|Is there a difference between trainee anaesthetists in learning to use the scopes|At analysis|||||||
1233521|NCT00633750|Secondary|Average Post-treatment Plasma Level of Erlotinib Hydrochloride|Post-treatment plasma level in µmol/L of erlotinib hydrochloride|After last dose of Tarceva, at 5-14 days, and before surgery|Participants with blood taken within 24 hours of last dose of erlotinib and before surgery|||µmol/L||Standard Deviation|Mean
1233522|NCT00633750|Secondary|Molecular Profile of Participants Who Are Responsive to Tarceva|Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained. Positive = > 10% of cell show staining, negative = < 10% of cells show staining|at 5-14 days|Participants with available pre- and post-treatment tissue and who demonstrated a post-treatment decrease in Ki67 levels compared to their pre-treatment levels|||participants|||Number
1233523|NCT00633750|Primary|Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva|In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.|5-14 days|Patients who received the study drug and who had available pre- and post-treatment tissue.|||participants|||Number
1233579|NCT00633074|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1233527|NCT00633594|Secondary|Progression Free Survival (PFS) of Phase I and Phase II Participants|"Defined as the time from entry onto study until lymphoma progression or death from any cause.~Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|All participants that received study treatment|||months||95% Confidence Interval|Median
1233528|NCT00633594|Secondary|Duration of Response (DoR) of Previously Treated and Previously Untreated Participants|Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression|All participants that received study treatment that were responders (achieved a PR or better)|||months||95% Confidence Interval|Median
1233529|NCT00633594|Secondary|Duration of Response (DoR) of Phase I and Phase II Participants|"Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.~Duration of Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression|All participants that received study treatment that were responders (achieved a PR or better)|||months||95% Confidence Interval|Median
1233530|NCT00633594|Secondary|Time to Best Response of Previously Treated and Previously Untreated Participants|Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years|All patients that received study treatment that were evaluable for a response assessment (2 previously untreated participants and 1 previously treated participant were considered unevaluable, discontinuing prior to first post-baseline response assessment)|||months||95% Confidence Interval|Median
1233531|NCT00633594|Secondary|Time to Best Response of Phase I and Phase II Participants|"Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.~Time to Best Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years|All participants that received study treatment that were evaluable for a response assessment (one participant in Phase I and two participants in Phase II were considered unevaluable, discontinuing prior to first post-baseline response assessment)|||days||Full Range|Median
1233532|NCT00633594|Secondary|Overall Response Rate (ORR) of Previously Treated and Previously Untreated Participants|Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.|Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months|The efficacy evaluable population (all participants who have received any study treatment)|||Participants|||Count of Participants
1233533|NCT00633594|Secondary|Overall Response Rate (ORR) of Phase I and Phase II Participants|Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.|Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months|The efficacy evaluable population (all participants who have received any study treatment)|||Participants|||Count of Participants
1233534|NCT00633594|Primary|Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II|"A count of affected participants with non-serious adverse events (regardless of relationship to study treatments) occurring in >= 15% of treated patients enrolled in the Phase II section of the study.~Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 subcutaneous Days 1, 4, 8, and 11 for Cycles 1-6"|Collected from day of first dose to 30 days after the last dose of study medication, a maximum of 18 weeks and 30 days after last study treatment|Includes patients that were enrolled in the Phase II section of the study|||participants|||Number
1233535|NCT00633594|Primary|Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants|"Determination of the maximum tolerated dose (MTD) of lenalidomide combined with bortezomib and rituximab, defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity according to the NCI CTCAE v. 4.03.~MTD of Lenalidomide was tested, included with 1.3 mg/m2 subcutaneous (D1, 4, 8, 11) bortezomib, 375 mg/m2 (D1, 8, 15 of Cycle 1, D1 on subsequent cycles) rituximab.~Three dose limiting toxicities were reported in two patients (grade 4 neutropenia and grade 3 neuropathy, grade 3 rash)"|Collected from day of first dose to the end of the first treatment cycle, up to 21 days|Includes patients that were enrolled in both lenalidomide dose levels (10 mg PO daily, 15 mg PO daily) in the Phase I portion of the study|||mg lenalidomide, orally, daily, day 1-14|||Number
1233536|NCT00633477|Secondary|Ventilator Free Days.|Number days participant was not on Ventilattor support.|Day 28|This study was terminated early when 17 subjects had received treatment.|||Days|||Number
1233537|NCT00633477|Secondary|Vasopressor Free Days.|Number days participant did not need vasopressors.|Day 28|This study was terminated early when 17 subjects had received treatment.|||days|||Number
1233538|NCT00633477|Secondary|ICU Free Days|Number days participant was not in ICU|Day 28|This study was terminated early when 17 subjects had received treatment.|||days|||Number
1233539|NCT00633477|Primary|All-cause Mortality|Mortality regardless of cause at Day 28|Day 28|Participants who received study drug|||Percent of Participant|||Number
1233540|NCT00633477|Primary|All-cause Mortality|Mortality regardless of cause at Day 28|Day 28|Participants who received study drug.|||Participants|||Number
1233541|NCT00633464|Secondary|Number of Participants With Serum Chemistry Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase: GR1=>ULN–2.5*ULN (upper limit of normal); GR2=>2.5–5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN–1.5*ULN, GR2=>1.5–3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN–1.5*ULN, GR2=>1.5–3.0*ULN, GR3=>3.0–6.0*ULN, GR4=>6.0*ULN.|Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)|Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time.|||participants|||Number
1233542|NCT00633464|Primary|Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST)|PD = At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.|Assessed at 6 week intervals for first 12 months from randomization, thereafter every 3 months (to a maximum follow-up for tumor response of 17 months).|All randomized participants.|||participants|||Number
1233543|NCT00633464|Secondary|Number of Participants With Hematology Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Hemoglobin:GR1=<LLN–10.0g/dL; GR2=<10.0–8.0g/dL; GR3:<8.0–6.5g/dL, GR4:<6.5g/dL. Platelets:GR1=<LLN–75.0*10^9/L; GR2=<75.0–50.0*10^9/L; GR3:<50.0–25.0*10^9/L, GR4:<25.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN–1.5*10^9 /L; GR2=<1.5–1.0*10^9/L; GR3:<1.0–0.5*10^9/L; GR4:<0.5*10^9/L. White blood cell (WBC):GR1=<LLN–3.0*10^9/L; GR2=<3.0–2.0*10^9/L; GR3:<2.0–1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal.|Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)|Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time.|||participants|||Number
1233544|NCT00633464|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. Other reasons for death included hepatic failure and respiratory distress.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 15 weeks (range: 3-54 weeks for ixabepilone arm; 3-36 weeks for ixabepilone+cetuximab arm)|All treated participants: Participants who received any treatment (ixabepilone or cetuximab).|||participants|||Number
1233559|NCT00633217|Secondary|Mean Change From Baseline in AM Pre-dose FEV1|Change from baseline was calculated as the value at Endpoint minus the baseline value. AM pre-dose FEV1, which is assessed using spirometry, is the maximum amount of air you can forcefully exhale in one second prior to taking the morning dose of study drug. Endpoint was defined as the last scheduled observation for AM pre-dose FEV1 during the 12-week treatment period.|Measurement of FEV1 prior to study drug administration; Baseline through Week 12|ITT Population. The numbers analyzed do not match Baseline numbers due to missing data for some participants.|||mL||Standard Error|Mean
1233545|NCT00633464|Secondary|Duration of Response|Defined as period from the time that measurement criteria are first met for CR or PR until first date of documented PD or death. Estimated using the Kaplan-Meier product-limit method; CI was computed using Brookmeyer and Crowley method. CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of LD of all target lesions with reference to baseline sum LD. PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.|From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 15.6 months)|Randomized participants with response of CR or PR. Participants who did not relapse or die were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
1233546|NCT00633464|Primary|Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])|The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method.|Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1233547|NCT00633464|Secondary|Time to Response|"Time to response is defined as the time from the date of start of treatment until measurement criteria are first met for PR or CR (whichever is recorded first).~CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions with reference to the baseline sum LD.~Time to response was estimated using the Kaplan-Meier product-limit method."|Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until CR or PR (maximum participant time to response of 18.3 weeks.)|Randomized participants with response of CR or PR.|||weeks||Full Range|Median
1233548|NCT00633464|Secondary|Progression Free Survival (PFS)|"PFS is defined as the time interval from date of randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley.~PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall."|From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 17 months)|All randomized participants. Participants who did not progress or die were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
1233549|NCT00633399|Secondary|Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8|This will involve looking at the change in HAM-D 17 scores during phase 2. For HAMD-17 the minimum is 0, the maximum is 52, and greater scores represent more symptoms.|8 weeks||||units on a scale||Standard Deviation|Mean
1233550|NCT00633399|Secondary|Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.|A secondary outcome measure will be remission rates (HAM-D 17 scores of less than 8) after treatment phase 2.. A remitted will be a patient with a final score of 7 or less on the HAMD-17 during phase 2.|8 weeks||||Percentage of patients|||Number
1233551|NCT00633399|Primary|The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2|The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2.|8 Weeks||||Percentage of patients|||Number
1233552|NCT00633360|Secondary|Percent Change in Daily Record of Severity of Problems (DRSP)|The DRSP is a 24-item self-administered daily dairy that assesses the severity of mood and physical symptoms which occur as part of the premenstrual syndrome and PMDD. Each question is rated on a scale of 1-6 with a total score range from 24-144. A higher score indicates greater symptom burden.|Baseline and 2 months||||percent change||Inter-Quartile Range|Median
1233553|NCT00633360|Primary|Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.|Baseline and 2 months||||percent change||Inter-Quartile Range|Median
1233554|NCT00633256|Secondary|Urinary Cotinine Level|Urinary Cotinine level at the 4-week follow up timepoint|4 Week Follow-up Timepoint|Subjects used for analysis are those who reached the 4 week followup timepoint.|||Mean ng/ml||Standard Deviation|Mean
1233555|NCT00633256|Secondary|Cigarettes Smoked Per Day|The number of cigarettes smoked per day at the 4-week follow up timepoint.|4 Week Followup|The number of subjects in the study at the 4-week timepoint.|||Cigarettes per day||Standard Deviation|Mean
1233556|NCT00633256|Primary|Cigarettes Smoked Per Day|The number of cigarettes smoked per day at the 1 week follow up time point.|1 week follow-up|The number of participants used for analysis were those who completed the 4-week follow-up timepoint.|||Cigarettes per day||Standard Deviation|Mean
1233557|NCT00633243|Primary|Number of Participants With a Sustained Virologic Response (SVR)|SVR is defined as continued undetectable HCV viral load at 24 weeks|24 weeks (end of treatment)|All subjects in mDOT arm and SAT arm who completed treatment.|||participants|||Number
1233558|NCT00633217|Secondary|Mean Change From Baseline in Peak Expiratory Flow|The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. This is measured by a peak flow meter which is a hand held device. Change from baseline was calculated as the average value over Weeks 1-12 minus the baseline value.|Baseline through Week 12|ITT Population. Some participants did not have measured values for peak expiratory flow and were thus not included in the analysis.|||Liters/minute (L/min)||Standard Error|Mean
1233575|NCT00633087|Secondary|Overall Survival||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
1233576|NCT00633087|Secondary|Progression-free Survival||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
1233560|NCT00633217|Primary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug|The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.|2 hours after administration of blinded study drug; Baseline through Week 12|Intent-to-Treat (ITT) Population: all participants who had been randomized to study drug. The numbers analyzed do not match Baseline numbers due to missing data for some participants.|||milliliters (mL)||Standard Error|Mean
1233561|NCT00633152|Secondary|The Safety of Ceftaroline Fosamil|Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI)|First dose of study drug through LFU Visit or 30 days after the last dose of study drug|||||||
1233562|NCT00633152|Secondary|The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit|Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit.|LFU Visit (21 to 35 days after end of therapy)|||||||
1233563|NCT00633152|Secondary|Clinical Relapse at the Late Follow-up Visit|Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit.|Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)|||||||
1233564|NCT00633152|Secondary|Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations|Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations.|TOC Visit (8 to 15 days after end of therapy)|||||||
1233565|NCT00633152|Secondary|The Microbiological Response at the TOC Visit in the mMITT and ME Populations.|Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.|TOC Visit (8 to 15 days after end of therapy)|||||||
1233566|NCT00633152|Secondary|Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.|Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.|End-of-therapy (EOT) visit|||||||
1233567|NCT00633152|Secondary|Clinical Cure Rate at the TOC Visit in the cMITT Population|Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.|TOC Visit (8 to 15 days after end of therapy)|||||||
1233568|NCT00633152|Primary|Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population|The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.|Test of Cure Visit (8 to 15 Days after end of therapy)|The Clinically Evaluable (CE) Population included all subjects who satisfied key minimum protocol criteria|||percentage of participants||95% Confidence Interval|Number
1233569|NCT00633152|Primary|Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population|The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.|Test of Cure Visit (8 to 15 days after end of therapy)|Modified-Intent-to-Treat (MITT) Population - Any randomized subjects that received any amount of study drug|||percentage of participants||95% Confidence Interval|Number
1233570|NCT00633139|Secondary|Change in Cerebrospinal Fluid (CSF) Sulfatide|Changes in CSF sulfatide from baseline to end of study (Week 52). Data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|ITT population|||%change in CSF sulfatide||95% Confidence Interval|Mean
1233571|NCT00633139|Primary|Relative Change in Mullen's Scales of Early Learning|Changes in Mullen's Scales of Early Learning are measured from baseline to end of study (Week 52) using Mullen's Scales of Early Learning. T scores, percentile ranks, and age equivalents can be computed for the four scales separately (visual reception, fine motor, expressive language, and receptive language). Relative change is calculated as percentage change from baseline divided by the age-difference in months between first and last visit. When Mullen's score decreases over time, it indicates the disease worsened over time. Data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|ITT population.|||Relative % change in Mullen's SOT||95% Confidence Interval|Mean
1233572|NCT00633139|Primary|Relative Changes (%) in Gross Motor Function Measurement (GMFM)|Change (percent change) in GMFM is measured from baseline to end of study (Week 52). GMFM is measured using GMFM-88. The GMFM-88 item scores can be summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score is between 0 (minimal) to 3 (maximum). The total GMFM-88 score is between 0 (minimal) to 264 (maximum). Relative changes in GMFM are calculated as percentage change from baseline divided by the age difference in months between first and last visit. The GMFM score decreases over time, which, indicates that the disease worsened over time. Score over time (SOT), data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|Intent to Treat (ITT) population included all the participants in the study.|||Relative % change in total GMFM-88 SOT||95% Confidence Interval|Mean
1233573|NCT00633126|Secondary|Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).|"A TEAE is any untoward medical occurrence a subject experiences following study drug administration.~Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7."|Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).|"per protocol~Out of 9 participants analyzed, 1 subject did not receive the full dose of study drug."|||events|||Number
1233574|NCT00633126|Primary|The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.|The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.|12 hours after infusion|per protocol|||ng/mL||Standard Deviation|Mean
1233583|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1233584|NCT00633074|Secondary|Duration of Solicited Local Symptoms|Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.|||Days||Full Range|Median
1233585|NCT00633074|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1233586|NCT00633074|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains|A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1233587|NCT00633074|Secondary|HI Antibody Seroconversion Factors|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1233588|NCT00633074|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1233589|NCT00633074|Secondary|Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1233590|NCT00633074|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1233591|NCT00633022|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Follow-up (Day 98)|Safety Population.|||Participants|||Count of Participants
1233592|NCT00633022|Secondary|Number of Participants With Urinalysis Dipstick Results|A urine dipstick test is a basic diagnostic tool used to determine pathological changes in a participant's urine in standard urinalysis. Data was analyzed for urine occult blood, urine glucose, urine ketones and urine protein ranging from 2+, trace, 1+, 3+, 1+or 1/4, 3+ or 1 and trace or 1/10, indicating proportional concentrations in the urine sample. Data has been presented for categories with values for positive findings.|Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98|Safety Population.|||Participants|||Count of Participants
1233593|NCT00633022|Secondary|Number of Participants With Hematology Abnormalities of PCI|Hematology range for PCI was: white blood cell count (WBC) low < 1.1 x109/ L; hemoglobin low <71 (age: 18-99) grams per litre (g/L), high >199 (age: 18-99) g/L; hematocrit low 0.201 (age: 18-99) ratio of 1 high 0.599 (age: 18-99) ratio of 1 and platelet count low < 80 x109/ L, high > 500 x109/ L. Categories with values have been presented.|Up to Follow-up (Day 98)|Safety Population.|||Participants|||Count of Participants
1233594|NCT00633022|Secondary|Number of Participants With Clinical Chemistry Abnormalities of PCI|Clinical chemistry range for PCI was calcium low <1.5 mill mole per litre (mmol/L), high > 3.24 mmol/L; creatinine high 155 mmol/L; glucose low < 2.2 (age: 13-99) mmol/L, high > 27.8 (age: 13-99) mmol/L; phosphorus low < 2.8 mmol/L, high > 6.5 mmol/L; sodium low < 125 mmol/L, high > 150 mmol/L. Categories with values have been presented.|Up to Follow-up (Day 98)|Safety Population.|||Participants|||Count of Participants
1233623|NCT00632749|Secondary|Pharmacodynamic Monitoring|"Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes).~An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material."|On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle only|Treated set||||||
1233595|NCT00633022|Secondary|Number of Participants With 12-lead Electrocardiogram (ECG) Findings|All 12-lead ECGs were obtained after the participant had rested in the supine position for at least 15 minutes. All ECGs were evaluated by the principal investigator or designee for any other abnormality of potential clinical importance (PCI). Data for abnormal ECG findings have been reported under abnormal - Not clinically significant (NCS) and Abnormal - Clinically significant (CS) categories. Data only for categories with values have been presented.|Days 1, 7, 14, 21, 28, 42, 56, 70, 84, 98|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
1233596|NCT00633022|Secondary|Mean Heart Rate at Indicated Time Points|Vital sign monitoring included heart rate measurement. Heart rate measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84).|Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98|Safety Population. Only those participants with data available at the specified time points were analyzed.|||beats per minute (bpm)||Standard Deviation|Mean
1233597|NCT00633022|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points|Blood pressure measurements were taken to observe vital signs and included SBP and DBP. SBP and DBP measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84).|Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98|Safety Population comprised of all participants who received at least one dose of study drug. Only those participants with data available at the specified time points were analyzed.|||millimeter of mercury (mm/Hg)||Standard Deviation|Mean
1233598|NCT00633022|Secondary|Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)|CRP is a protein that the liver makes when there is inflammation in the body. It's also called a marker of inflammation, and can be measured with an hs-CRP test. Blood samples were collected to analyze hs-CRP. Baseline was defined as the value on Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.|Baseline (Day 1) and Days 7, 14, 21, 28, 42, 56, 70, 84|PD Population. Only those participants with data available at the specified time points were analyzed.|||milligram per litre (mg/L)||Standard Deviation|Mean
1233599|NCT00633022|Secondary|Change From Baseline of the ‘Most Diseased Segment (MSD)’ Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy|Most diseased segment (MDS) mean of max TBR was mean of all the slice max TBR that compose the most diseased segment. TBR was derived by dividing the arterial vessel wall SUV (tissue) by the background venous blood pool SUV. Unless noted otherwise, the tissue max SUV value for each ROI was used as inputs to the TBR. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.|Baseline (Days -14 to -1) and up to Week 12|PD Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Deviation|Mean
1233600|NCT00633022|Primary|Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy|Qualifying artery was defined as the artery (left or right carotid or ascending aorta) with the highest segmental mean of maximum (max) TBR at Baseline. The TBR of the qualifying segment was to be ≥ 1.6. If more than one artery qualified, the hottest (greatest mean of max TBR) artery was the qualifying artery. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.|Baseline (Days -14 to -1) and up to Week 12|Pharmacodynamic (PD) Population comprised of all participants who provided PD data. Only those participants with data available at the indicated time points were analyzed.|||Maximum tissue to background ratio||Standard Deviation|Mean
1233601|NCT00633009|Secondary|The Safety of 15, 30 and 50µg/0.1mL Doses of LtSTA in Healthy Adult Volunteers Who Have Had no Known Previous Exposure to Leishmania Parasites|Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.|74 days||||No. of participants with reactions|||Number
1233602|NCT00633009|Primary|Sensitizing Effects of LtSTA in Leishmania Naive Adults|Skin test response of subjects in the trial were evaluated 48 hours post injection after each of three skin test given at 30 day intervals in naive individuals (no exposure to the Leishmania organism). (Actual times 0, 30 and 60 days).The outcome measure was designated as number of participants who became sensitized to the Leishmania antigen. This is defined as those participants that had a negative skin test result, followed by a positive response in a subsequent skin test without having been exposed to the Leishmania organism.|62 days|Number of participants completed.|||participants|||Number
1233603|NCT00632970|Secondary|Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.||24 weeks|Data can not be reported because the samples were never analyzed and therefore no data was analyzed.||||||
1233604|NCT00632970|Primary|Absolute Change in CD4 Cell Counts||24 and 48 weeks||||cells/mm^3||Full Range|Mean
1233605|NCT00632931|Primary|Change From Baseline in QTcF at 24 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 24 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
1233606|NCT00632931|Primary|Change From Baseline in QTcF at 12 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 12 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
1233772|NCT00631475|Secondary|Adverse Events (AE) Leading to Discontinuation of Study Drug.|Number of participants with at least one AE that led to permanent discontinuation of study treatment.|Start to end of study, up to 21 months|Study population|||participants|||Number
1233607|NCT00632931|Primary|Change From Baseline in QTcF at 8 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 8 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
1233608|NCT00632931|Primary|Change From Baseline in QTcF at 4 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.|Baseline and 4 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
1233609|NCT00632931|Primary|Change From Baseline in QTcF at 3 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 3 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
1233610|NCT00632931|Primary|Change From Baseline in QTcF at 2 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 2 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
1233611|NCT00632931|Primary|Change From Baseline in QTcF at 1 Hour|Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 1 hour|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
1233612|NCT00632931|Primary|Change From Baseline in QTcF at 0.5 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 0.5 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
1233613|NCT00632814|Secondary|Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment|Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).|9 months|Participants who completed the questionnaire.|||Scores on a scale||Standard Deviation|Mean
1233614|NCT00632814|Secondary|Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)|Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).|9 months|Participants who completed the questionnaire.|||Scores on a scale||Standard Deviation|Mean
1233615|NCT00632814|Secondary|Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment|The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition).|baseline and 9 months||||Scores on a scale||Standard Deviation|Mean
1233616|NCT00632814|Secondary|Actual Monthly rFVIII-FS Consumption||Up to 9 months||||IU/kg||Standard Deviation|Mean
1233617|NCT00632814|Secondary|Number of Participants in Each Group at the End of the Study||Up to 9 months|Participants were allowed to switch treatment groups upon occurrence of joint bleed. Therefore the number of participants per group at the end of the study is different from the number of participants per group at baseline.|||Participants|||Number
1233618|NCT00632814|Secondary|Number of Participants With Joint Bleeds During the 9-month Treatment Period||Up to 9 months||||Participants|||Number
1233619|NCT00632814|Secondary|Number of Participants With Bleeding Events During the 9-month Treatment Period||Up to 9 months||||Participants|||Number
1233620|NCT00632814|Secondary|Number of Bleeds Per Participant During the 9-month Treatment Period||Up to 9 months||||bleeds per participant||Full Range|Median
1233621|NCT00632814|Primary|Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period||Up to 9 months||||Percentage of participants|||Number
1233622|NCT00632749|Secondary|Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone|"The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol” -> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010).~Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated."|-0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours|Treated set||||||
1233624|NCT00632749|Secondary|AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)|||ng·h/L||Geometric Coefficient of Variation|Geometric Mean
1233625|NCT00632749|Secondary|AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated set (Only patients with observed cases (OC) values were analysed)|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1233626|NCT00632749|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma)|Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)|||hours||Full Range|Median
1233627|NCT00632749|Secondary|Cmax (Maximum Measured Concentration of Cytarabine in Plasma)|Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1233628|NCT00632749|Secondary|Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State)|tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.|||hours||Full Range|Median
1233629|NCT00632749|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma)|tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)|||hours||Full Range|Median
1233630|NCT00632749|Secondary|AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State|AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
1233631|NCT00632749|Secondary|AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State|AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
1233632|NCT00632749|Secondary|Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State)|Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1233633|NCT00632749|Secondary|AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
1233634|NCT00632749|Secondary|AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed)|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
1233635|NCT00632749|Secondary|Cmax (Maximum Measured Concentration of BI 811283 in Plasma)|Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1233636|NCT00632749|Secondary|Overall Survival (OS)|OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set|||days||Standard Deviation|Mean
1233637|NCT00632749|Secondary|Remission Duration|Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set (Only patients with observed cases (OC) values were analysed)|||days||Standard Deviation|Mean
1233638|NCT00632749|Secondary|Relapse Free Survival|"Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first.~Number of patients having relapse free survival are presented."|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set (Only patients with observed cases (OC) values were analysed)|||participants|||Number
1233639|NCT00632749|Secondary|Event Free Survival (EFS)|EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set|||days||Standard Deviation|Mean
1233640|NCT00632749|Secondary|Partial Remission|"Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.~Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or < 5% blasts in the presence of Auer rods or abnormal morphology."|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set|||participants|||Number
1233641|NCT00632749|Secondary|Incidence of Dose Limiting Toxicity (DLT)|Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD)|up to 28 days of treatment|Treated set|||participants|||Number
1233642|NCT00632749|Secondary|Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)|"The severity and timing of AEs indicates how well the treatment regimen was tolerated.~Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme."|Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days|Treated set|||participants|||Number
1233643|NCT00632749|Secondary|Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])|"Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria:~The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.~Complete remission (CR): morphologically leukaemia free state (i.e. bone marrow with < 5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥ 1,000/μL and platelets > 100,000/μL.~Complete remission with incomplete blood count recovery (“incomplete” CR, CRi).All of the above criteria for CR had to be met, except that neutrophils < 1,000/μL or platelets < 100,000/μL in the blood."|Data collected up to cut-off date 20Oct2011, Up to 1239 days|Treated set|||participants|||Number
1233644|NCT00632749|Primary|The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.|"The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only.~It was determined using a standard “3 + 3 design with de-escalation”."|up to 28 days of treatment|Treated set (TS): All patients who received at least one single dose of trial medication (BI 811283 or cytarabine) were considered.|||mg|||Number
1233645|NCT00632736|Secondary|Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26|"The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day. Wk, Week."|Week 4 and Week 26|All participants enrolled into this study from parent study 101468/168 who received at least one dose of study medication. Only 74 participants completed this questionnaire at Week 4, whereas 87 participants completed this questionnaire at Week 26.|||participants|||Number
1233646|NCT00632736|Primary|Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.|13 February 2004 through 31 March 2010|Safety Population: all participants who received at least one dose of study medication|||participants|||Number
1233647|NCT00632632|Primary|Clinician Administered PTSD Scale(CAPS)|"Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.~Subscales:~CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)"|6-months follow-up||||units on a scale||Standard Deviation|Mean
1233648|NCT00632632|Secondary|Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)|Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.|Immediately following treatment||||percentage of MDD remission|||Number
1233649|NCT00632632|Primary|Clinician Administered PTSD Scale(CAPS)|"Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.~Subscales:~CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)"|Immediately following treatment||||units on a scale||Standard Deviation|Mean
1233773|NCT00631475|Secondary|Number of Patients Exposed to Bosentan Over Time|Numbers of participants exposed to bosentan treatment over time|Start to end of study, up to 21 months|For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of OL treatment, respectively.|||Participants|||Number
1233650|NCT00632619|Secondary|Disruptive Behavior Disorder Scale Score for ODD Symptoms|parents rating all DSM symptoms of Oppositional Defiant Disorder on a 0-3 severity scale with higher scores indicating more severe symptoms and range is from 0-27 (8 DSM IV items and I item from DSM 3R)|week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
1233651|NCT00632619|Secondary|Children's Depression Rating Scale-Revised (CDRS-R) Total Score|rates 17 items of depression on a severity scale using information obtained from parent and child. Higher numbers indicate more severity symptoms and range is from 17 to 113.|Measured at Week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
1233652|NCT00632619|Secondary|Disruptive Behavior Disorder Scale Score for ADHD Symptoms|sum of severity rating for all 18 DSM (Diagnostic and Statistics Manual for Mental Disorders) IV ADHD symptoms and two from DSM 3R on a 0 to 3 scale obtained from parent rating; range is from 0 to 60 with higher numbers indicating more severe symptoms|Measured at Week12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
1233653|NCT00632619|Primary|Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe|averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.|measured at week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
1233654|NCT00632619|Secondary|Young Mania Rating Scale (YMRS) Score|rates manic like symptoms in children; 7 items ranging from 0-4 and 4 items on a 0-8 scale; higher scores indicate more severe symptom severity (min total score=0, max=60). There are no subscales. Symptom severity information is obtained from direct interview of parent and child. It was initially selected as the primary outcome but prior to commencement of data collection the Mood Severity Index (MSI) was chosen instead based on recently published work in a related study (see above).|Measured at weeks 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
1233655|NCT00632541|Secondary|Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.||24 months|Data for this secondary objective was not collected or analyzed.||||||
1233656|NCT00632541|Secondary|Assess the Overall Response Rate.||24 months|Data for this secondary objective was not collected or analyzed.||||||
1233657|NCT00632541|Secondary|Assess the Clinical Benefit Response: the Proportion of Patients With Clinical Benefit (CR+PR+SD > 6 Months Duration) Will be Assessed at the Completion of the Study.||6 months|Data for this secondary objective was not collected or analyzed||||||
1233658|NCT00632541|Primary|Progression-Free Survival|The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.|From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months||||months||95% Confidence Interval|Median
1233659|NCT00632502|Secondary|Maximum Plasma Concentration of Navarixin (Cmax)|Plasma samples were to be collected at baseline and up to 24 hours after dosing with navarixin at Weeks 1, 2, 3, and 4|Week 1, 2, 3, and 4|The analysis population was to include all participants who received at least one dose of navarixin and had navarixin plasma concentrations available for endpoint evaluation. The planned outcome measure was not evaluated.||||||
1233660|NCT00632502|Secondary|Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. A protocol-defined clinical event is an asthma exacerbation requiring addition of or increase in systemic steroids, as determined by the investigator.|Up to 4 weeks|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
1233661|NCT00632502|Secondary|Number of Participants Who Discontinued the Study Because of an Adverse Event|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
1233662|NCT00632502|Secondary|Number of Participants With a Laboratory Adverse Event|The endpoint measured was any laboratory (hematology, blood chemistry, or urinalysis) abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
1233663|NCT00632502|Secondary|Number of Participants With an Electrocardiogram Adverse Event|The endpoint measured was any electrocardiogram abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Week 4|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
1233664|NCT00632502|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
1233665|NCT00632502|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S])|The AQLQ[S] was administered at Baseline and at Weeks 2 and 4. The assessment consists of a 32-item questionnaire covering 4 domains: symptoms, emotional functioning, impact of environmental stimuli, and activity limitation. Each item receives a score from 1 (worst, or most affected) to 7 (not at all affected). The score is the mean across all items, and ranges from 1 to 7. The mean change from baseline is based on the average change over all post-baseline assessments.|Baseline and up to 4 weeks|The analysis population included all randomized participants who received at least one dose of study drug and had endpoint evaluation at Baseline or at any post-baseline visit|||Score on a scale||Standard Deviation|Mean
1233666|NCT00632502|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Spirometry was used to measure post-bronchodilator FEV1 at Baseline and before study drug administration at Weeks 1, 2, 3, and 4. Participants received 4 puffs of bronchodilator (salbutamol hydrofluoroalkane or equivalent) at 30-second intervals and spirometry was performed 30 minutes later. The mean change from baseline is based on the average change over all post-baseline assessments.|Baseline and up to 4 weeks|The analysis population included all randomized participants who received at least one dose of study drug and had endpoint assessment at Baseline or at any post-baseline visit|||Liters||Standard Deviation|Mean
1233667|NCT00632502|Secondary|Mean Change From Baseline in Total Asthma Symptom Score|Total Asthma Symptom Score is the sum of individual symptoms of wheezing, coughing, and dyspnea assessed twice daily (morning and evening) and is recorded on a comment diary card. Each of the symptoms receives a daily score from 0 (none) to 3 (severe), averaged over the two daily assessments. The total score ranges from 0 to 9, with a lower score indicating less severe asthma symptoms.|Baseline and Weeks 1, 2, 3, and 4|The analysis population included all randomized participants who received at least one dose of study drug and had Asthma Symptom Scores evaluated at the time points reported|||Score on a scale||Standard Deviation|Mean
1233668|NCT00632502|Secondary|Mean Change From Baseline in Sputum Absolute Neutrophil Count|Induced sputum samples were obtained at Baseline and at Weeks 2 and 4 of the treatment period. Samples were collected before study drug administration using the nebulizer method and sent to a central laboratory for analysis. An average was taken over all post-baseline samples collected no later than one day after the last dose of study drug.|Baseline and while on study drug (up to 4 weeks)|The analysis population included all randomized participants who received at least one dose of study drug and had sputum absolute neutrophil counts at Baseline or Week 4|||Neutrophil count X10^9/L||Standard Deviation|Mean
1233669|NCT00632502|Primary|Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL|Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period|Up to 4 weeks|The analysis population included all participants who received at least one dose of study drug|||Number of participants|||Number
1233670|NCT00632489|Primary|To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil|MTD for Panobinostat, twice weekly|18 months||||mg|||Number
1233671|NCT00632489|Secondary|To Evaluate the Tolerability and Preliminary Efficacy of Established Doses of LBH589 and Capecitabine With Lapatinib in a Limited Number of Patients With HER2+ Breast Cancer||18 months|||||||
1233672|NCT00632489|Secondary|To Evaluate the Antitumor Activity of LBH589 in Combination With Capecitabine in Patients With Refractory and Advanced Tumors||18 months|||||||
1233673|NCT00632489|Primary|To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil|MTD for Capecitabine, BID|18 months|MTD Determination only for part I patients (per protocol)|||mg/m2|||Number
1233674|NCT00632463|Secondary|The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers||18 Days||||Participants|||Number
1233675|NCT00632463|Secondary|Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.||Study day 33||||Participants|||Number
1233676|NCT00632463|Primary|Circulating RI-001 Titer|The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.|Study day 18||||Fold Change||95% Confidence Interval|Mean
1233677|NCT00632424|Secondary|Best Overall Response|Tumor assessment was performed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all clinical and radiological evidence of target lesions; Partial Response (PR) = at least 30% reduction in the sum of the longest diameter of all target lesions; Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of all target lesions; Stable Disease (SD) = neither PR nor PD criteria were met.|Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity|All treated participants who received at least one dose of ixabepilone were evaluable for tumor response.|||participants|||Number
1233689|NCT00632229|Secondary|Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms|This assessment measures the overall severity of obsessive-compulsive symptoms. It consists of a single item that is completed by a clinician with scores ranging from 0-6 with higher scores corresponding with more severe obsessive-compulsive symptoms. Thus, higher scores represent a worse outcome.|post-treatment|Includes those subjects who were randomized to their respective condition.|||Scores on a scale||Standard Deviation|Mean
1233678|NCT00632424|Secondary|PK: Mean Plasma Concentration Of Ixabepilone By Nominal Collection Time|Pharmacokinetics (PK) of ixabepilone were derived from plasma concentration versus time data. Individual patient PK parameter values were derived by standard non-compartmental methods by a validated pharmacokinetic analysis program. PK parameters include Cmax (maximum plasma concentration), Cmin (minimum plasma concentration), Tmax (time of maximum plasma concentration), AUC (0-TAU) (area under the curve in one dosing interval), T-half (plasma half-life).|Time 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 12.5, 13, 14, 15, 16, 17, 18, 20, 48, 72, and 168 hours post dose|Number of Participants Analyzed =All participants who received any treatment with ixabepilone and had adequate concentration profiles, n=all participants who received ixabepilone and had adequate concentration profiles at the specified time point. Cmax, Cmin, Tmax, AUC (0-TAU), and T-half were not calculated.|||ng/ml||Standard Deviation|Mean
1233679|NCT00632424|Secondary|Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval|QTc interval was defined as the measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, corrected for heart rate|Baseline (Day -1) and Day 1|Since study NCT00632424 (CA163-149) was discontinued early due to variability in oral ixabepilone concentrations with the potential to negatively impact both safety and efficacy, QTc data were collected but not analyzed.||||||
1233680|NCT00632424|Secondary|Number Of Participants With Liver Function and Renal Laboratory Abnormalities|Laboratory results were graded according to CTC v 3.0. Clinical laboratory evaluations included liver function (alanine aminotransferase [ALT], Aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin), and renal function (creatinine).|From first study drug administration through 30 days post dose|Since study NCT00632424 (CA163-149) was discontinued early due to variability in oral ixabepilone concentrations with the potential to negatively impact both safety and efficacy, liver and renal laboratory data were collected but not summarized.||||||
1233681|NCT00632424|Secondary|Number of Participants With Hematology Laboratory Abnormalities|Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB).|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.|||participants|||Number
1233682|NCT00632424|Secondary|Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)|AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.|||participants|||Number
1233683|NCT00632424|Secondary|Number of Participants With Adverse Event (AE), AE Leading to Discontinuation, Treatment-related AE, Treatment-related AE Leading to Discontinuation (DC), Most Common Treatment-Related Nonhematologic AE (>25%), Serious AE (SAE), or Treatment-related SAE|AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.|||participants|||Number
1233684|NCT00632424|Primary|Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)|The MTD was defined as the maximum dose which could be given to 6 participants such that not more than 1 participant experienced a DLT (or fewer than one-third if there were more than 6 treated participants) with at least 2 participants experiencing a DLT at the next higher dose level. The R2PD was to be based on the MTD and the assessment of any relevant chronic toxicities.|At the end of Cycle 1 (21 days).|Due to early study discontinuation, the MTD and RP2D of oral ixabepilone at the scheduled doses used in this study were not determined||||||
1233685|NCT00632424|Primary|Number of Participants With a Dose-Limiting Toxicity (DLT)|DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) <500 cells/mm^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.|During Cycle 1 (Day 0 through Day 21)|All participants who received at least one dose of ixabepilone.|||participants|||Number
1233686|NCT00632411|Primary|Continuous Abstinence|No cigarette smoking since two weeks after the target quit date.|Measured at Year 1|Participants|||Participants|||Count of Participants
1233687|NCT00632281|Secondary|Toxicity ot the Thorax|"Toxicity is defined as adverse events described in the CTCAE (version 3). Acute toxicity refers to adverse events that occurred up until 3 months after treatment and late toxicity as those occurring 3 months or longer after the end of treatment. Below are the Rates of grade 2 acute toxicity, grade 3 acute toxicity, late grade 3 toxicity, and late grade 4 toxicity"|up to 2 years, 9 months||||percentage of participants|||Number
1233688|NCT00632281|Primary|Disease Status|2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment)|2 yrs|44 lesions in 38 patients were treated with IMRT or 3D conformal beams on a prospective trial examining thoracic SBRT. Twenty-two of 32 primary lung cancer patients had biopsy-proven NSCLC (stage IA, 21 patients; stage IB, 11 patients). Six had metastatic disease. Six patients had 2 lesions treated simultaneously.|||percentage of participants|||Number
1233690|NCT00632229|Primary|Yale Brown Obsessive Compulsive Scale|This measure assesses obsessive-compulsive symptom severity across 10 items that are completed during an interview format with the person with OCD. These 10 items are summed to derive a total score, which ranges from 0-40 [Scale range: 0 (Minimum) - 40 (Maximum)] with higher scores corresponding to more severe obsessive-compulsive symptoms.|End of study (8 weeks)||||Scores on a scale||Standard Deviation|Mean
1233691|NCT00632203|Secondary|Tolerability of Maintenance Temozolomide|Tolerability was defined as number of participants with any adverse event leading to study discontinuation and/or study drug discontinuation.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)||||participants|||Number
1233692|NCT00632203|Secondary|Cancer-related Quality of Life (QoL) as Assessed by The European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire C30 Version 3.0 (QLQ-C30), and the EORTC Lung Cancer Module (QLQ-LC13)|The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Scores range from 0 -100. For functional and global QoL scales, higher scores mean a better level of function. For symptom-oriented scales, a higher score means more severe symptoms and a decrease in QoL. The EORTC QLQ-LC13 is a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It has a score range 0-100 with higher scores representing an increase in symptoms.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|No analysis was performed due to study termination.||||||
1233693|NCT00632203|Secondary|Number of Participants With Brain Metastases at First Progression|Brain Metastases were defined as radiological evidence of brain metastases on MRI.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|No analysis was performed due to study termination.||||||
1233694|NCT00632203|Secondary|Overall Survival|The overall survival was analyzed using the Kaplan-Meier method.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up||||months||95% Confidence Interval|Median
1233695|NCT00632203|Secondary|Time to Progression|"The time to progression (per response evaluation criteria in solid tumors [RECIST]) was analyzed using the Kaplan-Meier method.~Definitions of response per RECIST:~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): A decrease of at least 30% in the sum of the longest~diameter of target lesions.~Progressive Disease (PD): An increase of at least 20% in the sum of the longest~diameter of target lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease."|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to progression or up to 6 cycles (168 days) of study treatment||||months||95% Confidence Interval|Median
1233696|NCT00632203|Secondary|Time to Radiological Central Nervous System (CNS) Progression|"Defined as CNS progression as measured by MRI.~Time to CNS progression was analyzed using the Kaplan-Meier method."|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to radiological progression or the last known CNS progression-free date||||months||95% Confidence Interval|Median
1233697|NCT00632203|Primary|Number of Participants Who Had Brain Metastases|Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).|Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)|Evaluable population, defined as a participant who had at least one post-randomization MRI scan|||participants|||Number
1233698|NCT00632125|Primary|Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects|The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy|6 months|Safety population: The safety population consists of all patients that received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
1233699|NCT00632099|Primary|Cocaine Abstinence Based on Urine Toxicology Results|Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)|during last 3 weeks of the trial||||participants|||Number
1233700|NCT00632021|Secondary|Number of Participants With Unplanned Hospitalizations and Emergency Department Visits|Unplanned hospitalizations and Emergency Department visits|Measured at Day 30||||Participants|||Count of Participants
1233701|NCT00632021|Primary|Number of Serious Medication Errors as Determined by Interview and Medical Chart Review|Number of clinically important medication errors per patient|Measured at Day 30||||serious medication errors||Standard Deviation|Mean
1233702|NCT00631969|Secondary|Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.|||µg/L||Full Range|Geometric Mean
1233703|NCT00631969|Secondary|Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. AUC data were not available in 3 elderly patients.|||µg*h/L||Full Range|Geometric Mean
1233704|NCT00631969|Secondary|Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.|||μg/L||Full Range|Geometric Mean
1233705|NCT00631969|Secondary|Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics (PK) were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. The PK data of one elderly patient were only evaluable for Cmax but not for AUC.|||μg*h/L||Full Range|Geometric Mean
1233706|NCT00631969|Secondary|Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale|Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of participants|||Number
1233707|NCT00631969|Secondary|Satisfaction With Medication at Week 12 or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Satisfaction with medication” at LOCF expressed as the least square mean difference.|up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.|||scores on a scale||Standard Deviation|Mean
1233708|NCT00631969|Secondary|Change From Baseline in Confidence for Completion at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Confidence for completion” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
1233709|NCT00631969|Secondary|Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Satisfaction with orgasm” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
1233710|NCT00631969|Secondary|Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “ Pleasure of sexual activity” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
1233711|NCT00631969|Secondary|Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “ Erectile function satisfaction” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
1233712|NCT00631969|Secondary|Change From Baseline in Ease With Erection at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Ease with Erection” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
1233713|NCT00631969|Secondary|Number of Sexual Attempts Till First Successful Attempt||up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||Sexual Attempts||Standard Deviation|Mean
1233714|NCT00631969|Secondary|Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of ejaculation successes||Standard Deviation|Mean
1233715|NCT00631969|Secondary|Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of satisfactory attempts||Standard Deviation|Mean
1233716|NCT00631969|Secondary|Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of satisfactory erections||Standard Deviation|Mean
1233776|NCT00631449|Primary|We Will Use as Our Primary Endpoint the Proportion of Subjects in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.||Week 12||||participants|||Number
1233717|NCT00631969|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of successful erections||Standard Deviation|Mean
1233718|NCT00631969|Secondary|"Percentage of Subjects Achieving Back to Normal Erectile Function"|Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of participants|||Number
1233719|NCT00631969|Primary|Change From Baseline in Success of Erection Maintenance at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of success in maintenance||Standard Deviation|Mean
1233720|NCT00631969|Primary|Change in Percentage From Baseline in Success of Penetration at 12 Weeks|Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of successful penetrations||Standard Deviation|Mean
1233721|NCT00631969|Primary|Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF|The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
1233722|NCT00631917|Primary|Summary of the End of Study Colonoscopy Results|During each colonoscopy procedure, random biopsy samples were taken from normal appearing mucosa in both the cecum and rectum in addition to obvious endoscopically atypical areas. The mucosal biopsy samples were evaluated for mucosal hyperplasia, dysplasia, and inflammation. Anything noted as a distinct visual abnormality from cecum to rectum such as ulcers, erythematous mucosa, or polyps, was photographed and biopsied for histopathology evaluation. Colonic lesions were categorized according to location in the colon, size, number, and morphology.|54 weeks|Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.|||Percentage of Participants|||Number
1233723|NCT00631917|Secondary|Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target|The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)|Weeks 8, 30 and End of Study (54 weeks)|Full analysis set|||Percentage of Participants|||Number
1233724|NCT00631917|Secondary|Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment|Maximum hyperplasia score at end of study across rectal and cecal mucosa biopsy specimens. Score of 0 is no change from baseline, the minimum possible score. Score > 0 is worsening from baseline in which the maximum possible score is 3.|54 weeks|Primary analysis set|||participants|||Number
1233725|NCT00631917|Secondary|Percentage of Participants With Each of the Individual Components of Colonic Pathology|Assessment of the occurrence of the individual components (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) of the composite endpoint (colonic pathology) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.|54 weeks|Primary analysis set|||Percentage of Participants|||Number
1233726|NCT00631917|Primary|Percentage of Participants With Colonic Pathology|The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.|54 weeks|Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.|||Percentage of participants|||Number
1233727|NCT00631748|Secondary|Percentage of Participants Attaining Abstinence for Three Weeks|Abstinence was defined as a negative urine drug screen (UDS) (for cocaine) for three consecutive weeks of the trial measure at either time point Week 6 or Week 12|Abstinence defined as negative UDS for 3 consecutive weeks of the trial|At end of study (12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.|||Percentage of Participants|||Number
1233728|NCT00631748|Primary|Timeline Followback Interview (TLFB)|The primary outcome measure was the self-report of cocaine use in the past week, as assessed with a Timeline Followback Interview (TLFB). The TLFB is a questionnaire in which the subject is asked to self-report how much cocaine was used and how much money was spent on cocaine every day for the past 1-2 weeks.|Grams of cocaine used at end of study (12-weeks)|At end of study(12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.|||grams of cocaine used||Standard Deviation|Mean
1233774|NCT00631475|Primary|Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)|Mean extent of exposure to bosentan treatment in months|Start of study to end of study, up to 21 months|For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of open label (OL) treatment.|||months||Standard Deviation|Mean
1233729|NCT00631696|Secondary|Change From Baseline in Sperm Motility to Week 12|Mean sperm motility (percent motility representing grade a+b) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 12 was average of last 2 values within window of 2 to 133 days from Study Day 1 and at least 1 of the 2 values was non-missing. If there was only 1 assessment date within the stated window, then Week 12 was the value of that single assessment. If all the values within the window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.|||percent motility||Standard Deviation|Mean
1233730|NCT00631696|Secondary|Change From Baseline in Sperm Motility to Week 26|Mean sperm motility (percent motility representing grade a+b) was the average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 26 was average of the last 2 values within window of 134 to 252 days from Study Day 1 and at least 1 of the 2 values was non-missing. If only 1 assessment date within the stated window, Week 26 was the value of that single assessment. If all values within window were missing, the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT; N=number of participants with analyzable data at observation.|||percent motility||Standard Deviation|Mean
1233731|NCT00631696|Secondary|Change From Baseline in Sperm Motility to End of Study (EOS)|Mean sperm motility (percent motility representing grade a+b [a=sperm with progressive, straight-line motility; b=non-linear motility]) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|MITT; N=number of participants with analyzable data at observation; LOCF.|||percent motility||Standard Deviation|Mean
1233732|NCT00631696|Secondary|Change From Baseline in Testosterone to Week 12|Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.|||ng/dL||Standard Deviation|Mean
1233733|NCT00631696|Secondary|Change From Baseline in Testosterone to Week 26|Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT; N=number of participants with analyzable data at observation.|||ng/dL||Standard Deviation|Mean
1233734|NCT00631696|Secondary|Change From Baseline in Testosterone to End of Study (EOS)|End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|MITT; N=number of participants with analyzable data at observation; LOCF.|||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
1233735|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12|FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.|||IU/L||Standard Deviation|Mean
1233736|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26|FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT population; N=number of participants (observed cases) with analyzable data at observation.|||IU/L||Standard Deviation|Mean
1233737|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)|FSH minimum normal range 1.4 International units per liter (IU/L) to maximum normal range 18.1 IU/L. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|Modified intent-to-treat (MITT) population included all randomized participants who received at least 1 dose of study medication (either pregabalin or placebo) and were not discontinued for major violation at the site level. N=number of participants with analyzable data at observation; LOCF.|||IU/L||Standard Deviation|Mean
1233749|NCT00631657|Other Pre-specified|Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period|"NAW was defined as the number of times recorded for sleep diary question 4a How many times did you wake up during the night?, as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline NAW efficacy assessment.|||number of awakenings||Standard Deviation|Mean
1233775|NCT00631449|Secondary|Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) Will be Assessed as a Secondary Outcome.||Week 24|||||||
1233738|NCT00631696|Primary|Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)|Baseline is the average of sperm concentrations from semen samples collected on or before Study Day 1. End of study is average of sperm concentrations from semen samples collected at end of washout period (Week 26) following 12 weeks of double-blind treatment. Mean sperm concentration (MSC) of a visit is average of the 2 sperm concentration samples collected at that visit. If sperm concentration was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. Confidence intervals (CI) based on exact distribution.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|Per protocol analysis set: all randomized participants who had ≥8 weeks of study treatment, sperm concentration measurements at or after week 12 window, did not discontinue for site violations, and did not have any major protocol violations. N=number of participants with analyzable data at observation; Last observation carried forward (LOCF).|||percentage of participants||95% Confidence Interval|Number
1233739|NCT00631670|Secondary|Overall One Year Survival|Number of patients alive at one year after treatment|One year||||participants|||Number
1233740|NCT00631670|Secondary|Pain Relief|Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline.|12 weeks|Patients who reported pain at baseline|||participants|||Number
1233741|NCT00631670|Secondary|Neurologic Function|Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below.|2 years|6 patients presented with tumor-related deficits before treatment.|||participants|||Number
1233742|NCT00631670|Secondary|Local Control|Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery|1 year||||tumors|Participants||Number
1233743|NCT00631670|Primary|Toxicity|"Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as acute meaning during treatment and late meaning several months after treatment ended."|2 yrs||||participants|||Number
1233744|NCT00631657|Other Pre-specified|Change From Baseline in Investigator Global Rating (IGR) - 7-Day Discontinuation Period|The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 7-day Discontinuation Period to assess the effects of discontinuing treatment.|Baseline and End of 7-day Discontinuation Period|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a 7-Day Discontinuation Period IGR efficacy assessment.|||score on a scale||Standard Deviation|Mean
1233745|NCT00631657|Other Pre-specified|Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period|The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment.|Baseline and Week 26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 IGR efficacy assessment.|||score on a scale||Standard Deviation|Mean
1233746|NCT00631657|Other Pre-specified|Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period|SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization.|Baseline and Week 26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 SF-36 efficacy assessment.|||score on a scale||Standard Deviation|Mean
1233747|NCT00631657|Other Pre-specified|Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period|"Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 How satisfied are you about your sleep duration of last night?, as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Satisfaction with Sleep Duration efficacy assessment.|||score on a scale||Standard Deviation|Mean
1233748|NCT00631657|Other Pre-specified|Change From Baseline in Sleep Quality - 6-Month Treatment Period|"Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 Rate the quality of your sleep last night, as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Sleep Quality efficacy assessment.|||score on a scale||Standard Deviation|Mean
1233767|NCT00631488|Secondary|Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||mg.h/dL||Standard Error|Least Squares Mean
1233750|NCT00631657|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period|"WASO was defined as the time recorded for sleep diary question 5 How much time were you awake, after falling asleep initially?, as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline WASO efficacy assessment.|||minutes||Standard Deviation|Mean
1233751|NCT00631657|Secondary|Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period|"SL was defined as the time recorded for sleep diary question 3 How long did it take you to fall asllep?, as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline SL efficacy assessment.|||minutes||Standard Deviation|Mean
1233752|NCT00631657|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.|Up to 27 weeks|The AST population consisted of all participants who received at least one dose of any study drug.|||participants|||Number
1233753|NCT00631657|Secondary|Number of Participants Who Experienced Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.|Up to 31 weeks|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of any study drug.|||participants|||Number
1233754|NCT00631657|Primary|Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period|"TST was defined as the time recorded for sleep diary question 6 How much time did you actually spend sleeping? as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach."|Baseline and the Mean of Weeks 14-26|The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline TST efficacy assessment.|||minutes||Standard Deviation|Mean
1233755|NCT00631566|Secondary|To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.|This outcome measure was not analyzed/reported due to resource limitation.|at time of positive MRSA results|As requested, the number of participants was set to zero since this analysis was not conducted.||||||
1233756|NCT00631566|Secondary|To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.|This outcome measure was not analyzed/reported due to resource limitations.|At time of infection|As requested, the number of participants was set to zero since this analysis was not conducted.||||||
1233757|NCT00631566|Secondary|To Determine the Prevalence and Incidence of MRSA Colonization of the Nares, Throat, Perirectal, Axilla, and Groin Areas Among HIV Infected Patients and to Study Changes in the Colonization Rates Over Time.||Every 6 months|Due to small numbers, the colonization in the sites other than nares, the counts were not further identified between the treatment group and the placebo group.|||Participants|||Count of Participants
1233758|NCT00631566|Primary|The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization|MRSA colonization at 6-months post-randomization|6 months|Only 80% of the 49 initial randomizations had 6-month colonization data and were analyzed.|||Participants|||Count of Participants
1233759|NCT00631540|Secondary|30-day Clinical Success|< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.|30 Days|1 participant was lost to follow-up, 1 participant withdrew, 1 participant did not have core lab assessment.|||Percentage of Participants|||Number
1233760|NCT00631540|Secondary|Acute Procedural Success|< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.|Prior to Discharge|1 participant did not have core lab assessment for stenosis.|||Percentage of Participants|||Number
1233761|NCT00631540|Secondary|Technical Success|Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.|Prior to Discharge||||Percentage of Participants|||Number
1233762|NCT00631540|Secondary|Number of Participants With 9-month Major Adverse Events|Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.|9 Months|3 participants withdrew, 4 died, and 1 was lost to follow-up prior to 300 days.|||Participants|||Number
1233763|NCT00631540|Secondary|Number of Participants With 30-day Major Adverse Events|Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.|30 Days|1 participant withdrew and 1 participant was lost to follow-up prior to 30 days.|||Participants|||Number
1233764|NCT00631540|Primary|Primary Patency of the Treated Renal Artery|Based on ultrasound images assessed by core lab.|9 Months||||Lesions|Participants||Number
1233765|NCT00631488|Secondary|Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC|GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.|BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||pmole*h/L||Standard Error|Least Squares Mean
1233766|NCT00631488|Secondary|Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC|Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.|BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||pmol*h/L||Standard Error|Least Squares Mean
1233777|NCT00631410|Secondary|Sunitinib Relative Dose Intensity in the Treatment Arm B|Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period”n”: Cycle (n-1)*2+1 to n*2.|Up to 384 days (the last subject study discontinuation in the Treatment Arm B)|All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.|||percent of total planned dose||Standard Deviation|Mean
1233778|NCT00631410|Secondary|Sunitinib Relative Dose Intensity in the Treatment Arm A|Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period”n”: Cycle (n-1)*3+1 to n*3.|Up to 733 days (the last subject study discontinuation in the Treatment Arm A)|All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.|||percent of total planned dose||Standard Deviation|Mean
1233779|NCT00631410|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.|Up to 733 days (the last subject study discontinuation)|Summary statistics were not calculated due to a small number of subjects.|||days||Full Range|Median
1233780|NCT00631410|Secondary|Duration of Response (DR)|Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.|Up to 733 days (the last subject study discontinuation)|Summary statistics were not calculated due to a small number of subjects.|||days||Full Range|Median
1233781|NCT00631410|Secondary|Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.|Up to the last subject completed Cycle 24 or individual study discontinuation|All enrolled subjects who 1) had a diagnosis of locally-advanced or metastatic adenocarcinoma of the colon or rectum with measurable disease at baseline; 2) had received at least one dose of the investigational product; and 3) with efficacy data available after administration of the investigational product.|||participants|||Number
1233782|NCT00631410|Secondary|Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.|||nanogram per milliliter||Full Range|Median
1233783|NCT00631410|Secondary|Plasma Concentration of Sunitinib Active Metabolite (SU012662)|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.|||nanogram per milliliter||Full Range|Median
1233784|NCT00631410|Secondary|Plasma Concentration of Sunitinib|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.|||nanogram per milliliter||Full Range|Median
1233785|NCT00631410|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.|Up to 733 days (the last subject study discontinuation)|All subjects who received at least 1 dose of the study drug.|||participants|||Number
1233786|NCT00631371|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.|||months||95% Confidence Interval|Median
1233787|NCT00631371|Secondary|Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.|||percentage of participants||95% Confidence Interval|Number
1233788|NCT00631371|Secondary|Progression-Free Survival (PFS): Investigator-Assessment|PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.|||months||95% Confidence Interval|Median
1234003|NCT00629499|Primary|Tolerability of Adjuvant Nab Paclitaxel Using Weekly Dosing Schedule Assessed by Patient Survival, Disease Recurrence, and Treatment-related Toxicity.||18 Months|Patients were analyzed if they remained alive and without evidence of recurrence.|||participants|||Number
1233789|NCT00631371|Primary|Progression-Free Survival (PFS): Independent-Assessment|PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|Intent-to-treat (ITT) population included all participants who were randomized to the study.|||months||95% Confidence Interval|Median
1233790|NCT00631358|Secondary|Correlation Between Biomarker Expression and the Schirmer Test|Correlation factor: TNFmRNA vs. Schirmer|Baseline to 2 weeks||||Correlation Factor|||Number
1233791|NCT00631358|Secondary|Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining|"Correlation factor:~TNFmRNA vs. NaFl staining"|Baseline to 2 weeks|No data available for the no treatment group.|||Correlation factor|||Number
1233792|NCT00631358|Secondary|Correlation Between Biomarker Expression and Tear Film Break up Time|"Correlation factor:~TNFmRNA vs. TFBUT (Tear Film Break-up Time)"|Baseline to 2 weeks||||Correlation factor|||Number
1233793|NCT00631358|Secondary|Correlation Between Biomarker Expression and Ocular Symptoms|Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).|Baseline to 2 weeks||||Correlation factor|||Number
1233794|NCT00631358|Primary|Change in Levels of Biomarkers After Dosing With Maxidex|Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number.|Baseline to 2 weeks||||ddCt (Delta-Delta-Ct)||Standard Deviation|Mean
1233795|NCT00631189|Secondary|To Evaluate Clinical and Laboratory Safety|Serious Adverse Event and Adverse Event reported throughout the study|duration of study||||Adverse Events|||Number
1233796|NCT00631189|Secondary|Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data.||||||||
1233797|NCT00631189|Secondary|Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients|To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0–1) risk factor|from baseline and after 8 weeks of treatment||||Participants|||Number
1233798|NCT00631189|Secondary|Compare the Percentage of Variation of Phospholipase A2 (PLA2)|To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|from baseline and after 8 weeks of treatment||||percent of variation of phospholipase A2||Standard Deviation|Mean
1233799|NCT00631189|Secondary|Compare the Percentage of Variation of C-reactive Protein (CRP)|To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|baseline and after 8 weeks of treatment||||percent of variation of C-reactive prot.||Standard Deviation|Mean
1233800|NCT00631189|Secondary|Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment|To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|baseline and after 8 weeks of treatment||||percent. Apolipoprotein B/A1 decrease||Standard Deviation|Mean
1233801|NCT00631189|Secondary|Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks|To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Baseline and after 8 weeks of treatment||||percentage of triglycerides decrease||Standard Deviation|Mean
1233802|NCT00631189|Secondary|Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment|Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|After 8 weeks of treatment||||percentage of HDL-C increase||Standard Deviation|Mean
1233803|NCT00631189|Secondary|Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment|To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|from baseline and after 8 weeks of treatment||||percentage of total cholesterol decrease||Standard Deviation|Mean
1234030|NCT00629018|Primary|Changes in Left Ventricular Ejection Fraction|Left ventricular ejection fraction measured by echocardiography|5 years||||Percentage of ejection||Standard Deviation|Mean
1233804|NCT00631189|Secondary|To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Not done|||||||
1233805|NCT00631189|Secondary|To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Not done|||||||
1233806|NCT00631189|Primary|Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks|To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Change from baseline and after 8 weeks of treatment|92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group|||percentage of LDL-C decrease||Standard Deviation|Mean
1233807|NCT00631137|Secondary|Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months||baseline and at 1, 3, and 7|only 1 subject enrolled. Not enough to do analysis||||||
1233808|NCT00631137|Secondary|Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities||while receiving treatment|only 1 subject enrolled. Not enough to do analysis||||||
1233809|NCT00631137|Secondary|Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months||baseline and at 1, 3, 5, and 7 months|only 1 subject enrolled. Not enough to do analysis||||||
1233810|NCT00631137|Secondary|Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months||baseline and at 3 and 7 months|Only 1 subject accrued. Not enough data to analysis||||||
1233811|NCT00631137|Secondary|Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months||baseline and at 1, 3, 5, and 7 months|Only 1 subject accrued. Not enough data to analysis||||||
1233812|NCT00631137|Secondary|Muscle Strength Testing in Other Proximal Muscles (i.e., Knee Extensors, Knee Flexors, Arm Abductors, Elbow Extensors and Flexors, and Neck Flexors) as Assessed by Dynamometry at Baseline and at 1, 3, 5, and 7 Months||baseline and at 1, 3, 5, and 7 months|Only 1 subject accrued. Not enough data to analysis||||||
1233813|NCT00631137|Primary|Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months||baseline and at 1, 3, 5, and 7 months|Only 1 subject accrued. Not enough data to analysis||||||
1233814|NCT00631020|Secondary|Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline|Change from baseline self report of number of cigarettes per day compared to the past 7 days at each time point.|Weeks 6, 12, 16 and 24||||cigarettes/day||Standard Deviation|Mean
1233815|NCT00631020|Secondary|Change in Tobacco Dependence Compared to Baseline|Tobacco dependence was measured using the Cigarette Dependence Scale (CDS-12). The CDS-12 scale is a 12-item scale that assesses some components of formal diagnostic systems' (e.g., DSM-IV and ICD-10) definitions of dependence with an emphasis on compulsion to smoke, withdrawal, loss of control, time allocation, neglect of other activities, and persistence despite harm. Response choices are on a five-point Likert scale to measure dependence (low =1; high = 5), the total score is the sum of all 12 items with a score range of 12 - 60. The change in scores from baseline at each time point were measured.|Weeks 6, 12, 16 and 24||||units on a scale||Standard Deviation|Mean
1233816|NCT00631020|Secondary|Changes in Tobacco Withdrawal Symptoms Compared to Baseline|Tobacco withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS). Eight withdrawal symptoms are each rated for their severity on a scale from 0 (not present) to 4 (severe) for the past week and summed to calculate a total score at each time point, with a score range of 0-32. The average change from baseline for all participants at the specified time points were determined.|Weeks 6, 12, 16 and 24||||units on a scale||Standard Deviation|Mean
1233817|NCT00631020|Primary|7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)|The primary index of smoking behavior will be subject’s self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of <=8 ppm.|week 6, 12, 16 and 24||||participants|||Number
1233818|NCT00631020|Primary|Retention in Trial|Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no)|week 6||||participants|||Number
1233819|NCT00631020|Primary|Acceptance of Nicotine Replacement Therapy|Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.|week 2||||participants|||Number
1233820|NCT00631007|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.|The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.|Weeks 0-24|Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.|||mg/dL||Standard Deviation|Mean
1233821|NCT00631007|Primary|Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward|HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent|Weeks 0-24|Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.|||Percernt||Standard Deviation|Mean
1234031|NCT00629018|Primary|Heart Failure Mortality||5 years|The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.|||participants|||Number
1233822|NCT00630994|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Adverse events were assessed every cycle during treatment.|Up to 48 weeks||||participants|||Number
1233823|NCT00630994|Secondary|Number of Participants With Constitutional Symptoms|Constitutional symptoms including the presence of one or more of the following felt to be attributed to the disease: severe night sweats, fevers, weight loss and bone pain. Symptoms were assessed every cycle during treatment.|Up to 48 weeks|Study terminated prematurely. Analysis not performed.||||||
1233824|NCT00630994|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to progression of disease or death due to any cause.~Progression was defined as any one or more of the following:~1)progressive splenomegaly; 2) leukemic transformation confirmed by a bone marrow blast count of >= 20%; 3) an increase in peripheral blood blast percentage of >=20% that lasts for >= 8 weeks."|up to 3 years|Study terminated prematurely. Analysis not performed.||||||
1233825|NCT00630994|Secondary|Overall Survival(OS)|OS was defined as the time from registration to death of any cause.|up to 3 years|Study terminated prematurely. Analysis not performed.||||||
1233826|NCT00630994|Primary|Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.|"Confirmed response: objective status of CR, PR, or CI on 2 consecutive evaluations >=4 weeks apart.~CR:Complete resolution of disease-related symptoms and signs; peripheral blood count remission; normal leukocyte differential; bone marrow histologic remission.~PR: All criteria for CR except the bone marrow histologic remission. CI: one of the following in the absence of both disease progression and CR/PR: minimum (MI) 20-g/L increase (INC) in hemoglobin level; MI 50% reduction in palpable splenomegaly (>=10cm); MI 100% INC in platelet count(>=50000x10^9/L) or ANC (>=0.5x10^9/L)"|Every 4 weeks during treatment (up to 16 weeks)|All participants who met the eligibility criteria that have signed a consent form and went on treatment were evaluable for response. The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution.|||participants|||Number
1233827|NCT00630955|Secondary|Sedation Responses to Alcohol|Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher sedation.|Day 7|Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module|||units on a scale||Standard Deviation|Mean
1233828|NCT00630955|Secondary|Stimulation Responses to Alcohol|Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher stimulation.|Day 7|Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module|||units on a scale||Standard Deviation|Mean
1233829|NCT00630955|Primary|Baseline-adjusted Craving (YCS)|Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.|Day 7||||millimeters||Standard Error|Least Squares Mean
1233830|NCT00630955|Primary|Number of Drinks Consumed on Day 7||Day 7||||standard drinks||Standard Deviation|Mean
1233831|NCT00630916|Secondary|Aortic Valve Regurgitation|Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.|12 months||||Percent of participants|||Number
1233832|NCT00630916|Primary|Effective Orifice Area|Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.|12 months||||cm^2||Standard Deviation|Mean
1233833|NCT00630916|Primary|Mean Gradient|Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.|12 months|Patients with 12 month hemodynamic evaluations|||mmHg||Standard Deviation|Mean
1233834|NCT00630916|Primary|Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair|Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring >30 days after valve implant.|Late postoperative|Cumulative follow-up in years occurring post 30 days|||Percent occurrence per patient-year|Participants|95% Confidence Interval|Mean
1233835|NCT00630877|Primary|FAST Responsiveness--maximum Flushing Severity Score|The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.|Study start to Day 43|Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.|||Units on a scale|||Number
1233836|NCT00630877|Primary|FAST Responsiveness--mean Flushing Severity Score|The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.|Study start to Day 43|Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.|||Units on a scale|||Number
1233848|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) Mass/Voltage Ratio at Month 6, Month 12|LV mass was calculated from the product of the myocardial volume and specific gravity of heart muscle, estimated by echocardiography. QRS score (the sum of QRS voltages in the peripheral leads) was used as an index of “electrical” LV mass.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||gram/millivolt||Standard Deviation|Mean
1233837|NCT00630877|Primary|FAST Longitudinal Construct Validity--maximum Flushing Severity Score|The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).|Week 1 to Week 2|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Spearman correlation coefficient|||Number
1233838|NCT00630877|Primary|FAST Longitudinal Construct Validity--mean Flushing Severity Score|The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).|Week 1 to Week 2|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Spearman correlation coefficient|||Number
1233839|NCT00630877|Primary|FAST Cross-sectional Construct Validity--maximum Flushing Severity Score|The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.|Week 1|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Spearman correlation coefficient|||Number
1233840|NCT00630877|Primary|FAST Cross-sectional Construct Validity--mean Flushing Severity Score|The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.|Week 1|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Spearman correlation coefficient|||Number
1233841|NCT00630877|Primary|FAST Test-retest Reliability--maximum Flushing Severity Score|Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.|Week 1 to Week 2|Subjects with stable flushing symptoms from Week 1 to Week 2.|||Intraclass correlation coefficient|||Number
1233842|NCT00630877|Secondary|Maximum Severity of Flushing Events Overall During the Study|The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.|Week 1 to Week 6|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Percentage of subjects|||Number
1233843|NCT00630877|Primary|Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score|Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.|Week 1 to Week 2|Subjects with stable flushing symptoms from Week 1 to Week 2.|||Intraclass correlation coefficient|||Number
1233844|NCT00630864|Other Pre-specified|Change From Baseline in Troponin I Levels at Week 2, Week 6 , Month 3, Month 6, Month 12|Troponin I is a cardiac injury biomarker. Higher concentrations of this marker in blood are associated with heart injury.|Baseline, Week 2, Week 6 , Month 3, Month 6, Month 12|ITT population. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category. Data prior Month 6 were not anticipated to be informative hence were not analyzed.|||nanogram/mL||Standard Deviation|Mean
1233845|NCT00630864|Other Pre-specified|Change From Baseline in Karnofsky Performance Status Scale at Month 6, Month 12|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
1233846|NCT00630864|Other Pre-specified|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) at Week 2, Week 6, Month 3, Month 6, Month 12|NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category. Data prior Month 6 were not anticipated to be informative hence were not analyzed.|||picogram/mL (pg/mL)||Standard Deviation|Mean
1233847|NCT00630864|Other Pre-specified|Change From Baseline in Left Atrial (LA) Volume Index at Month 6, Month 12|LA volume index (LAVI), was the value of LA volume divided by body surface area, to measure LA size.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||milliliter/square meter (mL/m^2)||Standard Deviation|Mean
1233879|NCT00630838|Primary|Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).|The primary outcome measure is reporting the number of participants diagnosed with Hirschsprung-associated enterocolitis (HAEC) after pullthrough procedure.|6 months post-pullthrough||||participants|||Number
1233849|NCT00630864|Other Pre-specified|Change From Baseline in e:e’ Lateral Ratio , Ratio of Peak Mitral Early Diastolic and Atrial Contraction Velocity (E/A Ratio) at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Ratio of early (E) diastolic transmitral flow velocity and atrial (A) contraction velocity (E/A) and ratio of the early (E) diastolic transmitral flow velocity to the mitral annular velocity (e’) (E/e’) were estimated.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||ratio||Standard Deviation|Mean
1233850|NCT00630864|Other Pre-specified|Change From Baseline in Doppler Data at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Doppler principle was used to measure the mitral peak early (E) diastolic transmitral flow, mitral peak atrial (A) contraction velocity and annular velocities at the lateral and septal areas of the mitral annulus. s': systolic velocity during ejection, e': early diastolic mitral annular velocity, a': late diastolic mitral annular velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||centimeter per second (cm/sec)||Standard Deviation|Mean
1233851|NCT00630864|Other Pre-specified|Change From Baseline in Tricuspid Pulmonary Artery Systolic Pressure (PASP) at Month 6, Month 12|Systolic right ventricular pressure can be estimated on echocardiography by adding right atrial pressure (RAP) to the trans-tricuspid gradient derived from the tricuspid regurgitation velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1233852|NCT00630864|Other Pre-specified|Change From Baseline in Tricuspid Peak Velocity at Month 6, Month 12|Tricuspid peak velocity was measured by echocardiography.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||meter per second (m/sec)||Standard Deviation|Mean
1233853|NCT00630864|Other Pre-specified|Change From Baseline in Aortic Annulus Diameter at Month 6, Month 12|The diameter at the base of the aortic root, the basal ring, is also called the aortic annulus diameter.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||centimeter (cm)||Standard Deviation|Mean
1233854|NCT00630864|Other Pre-specified|Change From Baseline in Isovolumetric Relaxation Time (IVRT), Mitral Deceleration Time at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. IVRT is the time between the closure of the aortic valve and the opening of the mitral valve. Mitral deceleration time (MDT) was the time taken from the maximum E point wave to baseline. E wave arises due to early diastolic filling.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||msec||Standard Deviation|Mean
1233855|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular Mass (LVM) at Month 6, Month 12|LV mass was calculated from the product of the myocardial volume and specific gravity of heart muscle, estimated by echocardiography. Increased LVM was associated with cardiovascular morbidity and mortality.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||gram||Standard Deviation|Mean
1233856|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) Ejection Fraction at Month 6, Month 12|Cardiac MRI was done to measure left ventricular ejection fraction (LVEF) which was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||percentage of EDV||Standard Deviation|Mean
1233857|NCT00630864|Other Pre-specified|Change From Baseline in Fractional Shortening at Month 6, Month 12|Fractional shortening (FS) is the fraction of any diastolic dimension that is lost in systole. Percent of FS was calculated as difference between end-diastolic dimension (EDD) and end-systolic dimension (EDS) divided by EDD.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||percentage of EDD||Standard Deviation|Mean
1233858|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) End Systolic Volume, Left Ventricle (LV) Stroke Volume at Month 6, Month 12|Cardiac MRI was done to measure left ventricular (LV) end systolic volume, left ventricle (LV) stroke volume.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||milliliter (mL)||Standard Deviation|Mean
1233859|NCT00630864|Other Pre-specified|Change From Baseline in Left Atrial Volume at Month 6, Month 12|Left atrial volume was measured by echocardiography.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||cubic centimeter (cc)||Standard Deviation|Mean
1233909|NCT00630747|Secondary|Change From Baseline in Mean Combined Liver and Spleen Volume at Week 105|Determined by Magnetic Resonance Imaging (MRI). The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom combined liver and spleen volume were recorded at baseline and at Week 105.|||cubic centimeters (cc)||Standard Error|Mean
1233860|NCT00630864|Other Pre-specified|Change From Baseline in Echocardiography (ECHO) Parameters at Month 6, Month 12|Echocardiography was used to measure interventricular septal thickness (IVST), posterior left ventricular wall thickness (PLVWT), right ventricular wall thickness (RVWT), left atrial diameter (LAD): anterior-posterior (ant-post), medio-lateral, superior-inferior (sup-inf) and left ventricular end diastolic diameter (LVED), relative LV wall thickness (RLVWT).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||millimeter (mm)||Standard Deviation|Mean
1233861|NCT00630864|Other Pre-specified|Change From Baseline in Overall Quality of Life and Individual Domains of the Short-form-36 (SF-36) at Month 6, Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health and two total scores (physical component summary [PCS] and mental component summary [MCS]. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
1233862|NCT00630864|Other Pre-specified|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, Month 12|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). mBMI was calculated by multiplying BMI by serum albumin levels [gram/liter (g/L)]. mBMI was measured as kg/m^2*g/L. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||kg/m^2*g/L||Standard Deviation|Mean
1233863|NCT00630864|Other Pre-specified|Change From Baseline in Heart Rate Response to Deep Breathing (HRDB) at Month 6 and Month 12|HRDB test was used to evaluate the cardio-vagal response. Participant took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. The main factor affecting HRDB is age, with older patients showing less heart rate variability. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as the normal deviates (Z-score), the defined position of the result in normal probability distribution with a mean of 0 and standard deviation (std) of 1 and describes how far a score is (in std) from the mean.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||Z-score||Standard Deviation|Mean
1233864|NCT00630864|Other Pre-specified|Change From Baseline in Nerve Conduction Studies (NCS) at Month 6, Month 12|NCS: quantitative measures of peripheral nerve dysfunction consists of 5 attributes: peroneal nerve (PN) motor distal latency, PN compound muscle action potential, PN motor conduction velocity, tibial nerve distal motor latency, sural nerve sensory nerve action potential. Normal deviates (Z-score) summated into composite score (higher score=worsened nerve fiber function). Z-score is the defined position of the result in normal probability distribution with a mean of 0 and standard deviation (std) of 1 and describes how far a score is (in std) from the mean.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||Z-score||Standard Deviation|Mean
1233865|NCT00630864|Other Pre-specified|Change From Baseline in Norfolk Quality of Life – Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, Month 12|Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7: scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale:0=no problem, 4=severe problem(except item 32: -2=much better, 0=about same, 2=much worse).Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptom(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12);higher score=greater impairment, for each. Total score=-2 to 138 (higher score=worse QOL).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
1233866|NCT00630864|Other Pre-specified|Change From Baseline in Total Quality of Life (TQOL) Score at Month 6, Month 12|TQOL= sum of all Norfolk Quality of Life–Diabetic Neuropathy (Norfolk QOL-DN) items,a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on QOL of participants with DN; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). Total TQOL score=-2 to 138;higher score=worse quality of life.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
1233867|NCT00630864|Other Pre-specified|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6, Month 12|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than [<] 2) in Neuropathy Impairment Score- Lower Limb (NIS-LL) score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 6, Month 12|Data on NIS-LL was reported in individual participant listings but responder status was not statistically summarized.||||||
1233933|NCT00630487|Secondary|Change From Baseline in Cardiovascular Risk Factors|Change in values of laboratory tests indicative of possible cardiovascular risk factors: high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, N-terminal pro brain natriuretic peptide)|Baseline, Week 52, Week 78|||||||
1233868|NCT00630864|Other Pre-specified|Change From Baseline in the Neuropathy Impairment Score-Lower Limb (NIS-LL) at Month 6, Month 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0 to 4 scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
1233869|NCT00630864|Other Pre-specified|Change From Baseline in the Neuropathy Impairment Score (NIS) at Month 6, Month 12|NIS assessed cranial nerves(nerve 3,6; facial, palate and tongue weakness),muscle weakness (respiratory; neck, elbow(E), wrist(W), finger(F), hip, knee(K) flexion; shoulder, thumb abduction; brachioradialis; E, W, hip, K extension; F spread; toe, dorsal and plantar ankle flexors; toe extensors); score: 0-4, higher score=more weakness, reflexes(biceps and triceps brachii; brachioradialis; quadriceps femoris; triceps surae), index F and great toe sensation(touch pressure, pin-prick, vibration, joint position)score:0=normal,1=decreased or 2=absent. Total score=0-244, higher score=more impairment.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
1233870|NCT00630864|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events||Baseline up to Month 12|ITT population included all participants who received at least 1 dose of study medication.|||participants|||Number
1233871|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Holter Monitoring Findings|Holter monitoring recorded heart rhythm. Holter monitoring abnormality criteria: any abnormality, atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (VT), sustained VT and sinus pause.|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.|||participants|||Number
1233872|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|ECG: investigator assessed test to assess cardiac function. ECG abnormality criteria: any abnormality, arrhythmia, rhythm, conduction, morphology, myocardial infarction, ST segment, T waves and abnormal U waves.|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.|||participants|||Number
1233873|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings|ECHO: investigator assessed test to assess cardiac function. ECHO abnormality criteria: any abnormality, valvular abnormality, pericardial effusion, abnormal regional wall motion, inferior vena cava respiratory variation, posterior (P) left ventricular (LV) wall/septal (S) thickness, right ventricular thickness, ejection fraction, ratio of early (E) diastolic transmitral flow and atrial(A) contraction velocity (E/A), ratio of ‘E’to lateral/septal mitral annular velocity (e') (E/e'prime lateral, E/e'prime septal), E deceleration time (DT), isovolumic relaxation time (IVRT).|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.|||participants|||Number
1233874|NCT00630864|Other Pre-specified|Number of Participants With Greater Than or Equal to Grade 3 Treatment-Emergent Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. On the basis of intensity, grade 3 was referred as severe, grade 4 as life-threatening and grade 5 as death.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least 1 dose of study medication.|||participants|||Number
1233875|NCT00630864|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least 1 dose of study medication.|||participants|||Number
1233876|NCT00630864|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Month 6 and 12|TTR tetramer was assessed using a validated immunoturbidimetric assay. The FOI is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1233877|NCT00630864|Primary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Week 6|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 6|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1233878|NCT00630838|Primary|Severity of Clinical Episodes of HAEC|The severity of clinical episodes of HAEC will be stratified into three grades (mild, moderate, or severe). Grades of severity reported are based on first episodes.|6 months||||participants|||Number
1233880|NCT00630825|Secondary|Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration).|Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.|||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
1233881|NCT00630825|Secondary|Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire|This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.|Baseline and 4 and 8 and 16 weeks|The items in the Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. Therefore, no participants were analyzed for validation purposes.||||||
1233882|NCT00630825|Secondary|Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire|The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6–point scale ranging from 1 “completely dissatisfied” to 6 “completely satisfied”; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 “all of the time” to 4 “none of the time”; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 “all of the time” to 4 “none of the time.” These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized.|Baseline and 4 and 8 and 16 weeks|Participants in the per-protocol population with evaluable PAM-D-S questionnaire data. The per-protocol population consisted of participants who received at least one dose of study medication, had no significant protocol violations, completed the double-blind treatment phase, and were compliant with the study drug.|||percentage of participants|||Number
1233883|NCT00630825|Secondary|Change From Baseline in Lipids|Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable lipid data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Full Range|Median
1233884|NCT00630825|Secondary|Rate of Hypoglycemia Per 30 Days|Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 16 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||events per participant per 30 days||Standard Deviation|Mean
1233885|NCT00630825|Secondary|Number of Participants With a Hypoglycemic Event|A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of <50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||participants|||Number
1233886|NCT00630825|Secondary|Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores|Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.|Baseline and 4 and 8 and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable Gastroparesis Cardinal Symptom Index (GCSI) questionnaire data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Deviation|Mean
1233887|NCT00630825|Secondary|Nausea and Dyspepsia Measured by Visual Analog Scale|Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.|One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits|Participants who received at least one dose of LY2189265 or Placebo with evaluable nausea or dyspepsia (abdominal pain and bloating) data.|||units on a scale||Standard Deviation|Mean
1233888|NCT00630825|Secondary|Change From Baseline in Waist Circumference|Mean change from baseline in waist circumference (a measure of central obesity).|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable waist circumference data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||centimeters (cm)||Standard Deviation|Mean
1233889|NCT00630825|Secondary|Change From Baseline in Body Weight|LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|Baseline, 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
1233890|NCT00630825|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.|Baseline and 4 and 8 and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1233891|NCT00630825|Secondary|Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)|Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable HOMA2-%B or HOMA2-%S data.|||percentage of HOMA2||Standard Deviation|Mean
1233892|NCT00630825|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.|Participants who received at least one dose of LY2189265 or Placebo with evaluable blood glucose (SMBG) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1233893|NCT00630825|Secondary|Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)|Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie [Kcal], 103 grams [g] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting [0]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.|Baseline and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glucose excursion data.|||millimoles per liter (mmol/L)*minute||Standard Deviation|Mean
1233894|NCT00630825|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1233895|NCT00630825|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus|Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1233896|NCT00630786|Secondary|Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher|Laboratory values were assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (version 3.0) according to the following: 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-threatening; 5 = Fatal.|From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.|Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.|||participants|||Number
1233897|NCT00630786|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, and includes any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition from the time that a participant has signed informed consent to the time of initiation of investigational product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following:~= Mild: Aware of sign or symptom, but easily tolerated~= Moderate: Discomfort enough to cause interference with usual activity;~= Severe: Incapacitating with inability to work or do usual activity;~= Life-threatening: an event in which the patient was, in the view of the investigator, at risk of death at the time of the event;~= Fatal."|From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.|Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.|||participants|||Number
1233998|NCT00629525|Secondary|Progression Free Survival|Time in months from the start of study treatment to the date of first progression according to RECIST 1.0, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Patients were followed for a median of 315 days, with the last patient censored at 1309 days.|Intent to treat|||months||95% Confidence Interval|Median
1233898|NCT00630786|Secondary|Number of Participants With Anti-therapeutic Antibodies|Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay.|Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks.|Safety analysis set, including all randomized patients who received at least 1 dose of investigational product. N indicates the number of patients with immunoassay results at the specified time points.|||participants|||Number
1233899|NCT00630786|Secondary|Duation of Response|The interval in days from the first confirmed objective response to disease progression per the modified RECIST criteria or death. Calculated only for participants with an objective response.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Patients with an overall objective response||||||
1233900|NCT00630786|Secondary|Time to Response|The interval in days from the first dose of study therapy to the date of first confirmed objective response. Calculated only for participants with an objective response.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Patients with an overall objective response||||||
1233901|NCT00630786|Secondary|Number of Participants With Disease Control|Disease control defined as participants with an overall objective response of complete response (CR), partial response (PR), or stable disease during the treatment period, assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST). Responses were confirmed no less than 4 weeks after the criteria for response were first met. CR defined as the disappearance of all target and non-target lesions and no new lesions. PR defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the nadir LD since the treatment started.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||participants|||Number
1233902|NCT00630786|Secondary|Overall Survival|Kaplan-Meier estimate of time from enrollment to death from any cause|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||months||95% Confidence Interval|Median
1233903|NCT00630786|Secondary|Progression-free Survival|Kaplan-Meier estimate of the median time from enrollment to death from any cause or disease progression. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||weeks||95% Confidence Interval|Median
1233904|NCT00630786|Primary|Number of Participants With an Objective Response|An overall objective response of either a confirmed complete response or partial response, where the overall objective response was equivalent to the best overall response recorded for each participant from enrollment until disease progression or recurrence. Tumor response was assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Responses were confirmed no less than 4 weeks after the criteria for response were first met. Complete response defined as the disappearance of all target and non-target lesions and no new lesions. Partial response defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status and Baseline measurable disease.|||participants|||Number
1233905|NCT00630786|Primary|Part 1: Number of Participants With Dose-limiting Toxicities|"A dose-limiting toxicity (DLT) was defined as any grade 3 or 4 conatumumab-related or combination (panitumumab and conatumumab)-related adverse event, or grade 3 or 4 laboratory abnormality that occurred during the first 4 weeks (28 days) of treatment with panitumumab and conatumumab. Anemia and lymphopenia were not considered DLTs.~Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to grade all adverse events and toxicities."|4 weeks|DLT-evaluable patients were those who received ≥ 2 doses of panitumumab and conatumumab as scheduled (ie, weeks 1 and 3) and completed 4 weeks (28 days) of treatment, or had a DLT within the first 4 weeks (28 days) of treatment.|||participants|||Number
1233906|NCT00630747|Primary|Change From Baseline in Mean Distance Walked in the 6-minute Walk Test (6MWT) at Week 105|Determined on a walking course. The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom distance walked was recorded at baseline and at Week 105.|||meters (m)||Standard Error|Mean
1233907|NCT00630747|Secondary|Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 105|Determined by echocardiogram. LVMI indexed to body surface area (g/m^2). The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom cardiac LVM were recorded at baseline and at Week 105.|||g/m^2||Standard Error|Mean
1233908|NCT00630747|Secondary|Change From Baseline in Mean Normalized Urine Glycosaminoglycans (GAG) Levels at Week 105|Determined by urine testing. The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom normalized urine GAG levels were recorded at baseline and at Week 105.|||mcg GAG/mg creatinine||Standard Error|Mean
1233910|NCT00630747|Secondary|Change From Baseline in Mean Passive Joint Range of Motion (JROM) at Week 105|Change was calculated as Week 105 minus baseline. Global JROM (% normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension [Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).|Baseline and at Week 105|All participants for whom passive JROM were recorded at baseline and at Week 105.|||percentage of JROM||Standard Error|Mean
1233911|NCT00630747|Primary|Change From Baseline in Mean Percent Predicted Forced Vital Capacity (FVC) at Week 105|Determined by spirometry. The change is calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom percent predicted FVC were recorded at baseline and at Week 105.|||percent predicted FVC||Standard Error|Mean
1233912|NCT00630734|Secondary|Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||Standard Deviation|Mean
1233913|NCT00630734|Secondary|Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|Dosing interval of 24 hours|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*h/ml||Standard Deviation|Mean
1233914|NCT00630734|Secondary|Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||Standard Deviation|Mean
1233915|NCT00630734|Secondary|Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|Dosing interval of 24 hours|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*h/ml||Standard Deviation|Mean
1233916|NCT00630734|Other Pre-specified|Ritonavir Maximum Plasma Concentration (Cmax)|Cmax of ritonavir over a 12-hour dosing interval|0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||Standard Deviation|Mean
1233917|NCT00630734|Other Pre-specified|Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of ritonavir over a 12-hour dosing interval.|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*hr/ml||Standard Deviation|Mean
1233918|NCT00630734|Other Pre-specified|Darunavir Maximum Plasma Concentration (Cmax)|Cmax of darunavir over a 12-hour dosing interval|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||Standard Deviation|Mean
1233919|NCT00630734|Other Pre-specified|Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of darunavir over a 12-hour dosing interval.|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*h/ml||Standard Deviation|Mean
1233920|NCT00630734|Primary|Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)|Cmax of pravastatin when administered with darunavir/ritonavir divided by the Cmax of pravastatin when administered alone.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||95% Confidence Interval|Mean
1233921|NCT00630734|Primary|Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*hr/ml||95% Confidence Interval|Mean
1233922|NCT00630539|Secondary|Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index||Week 4|ITT|||percentage of parabasal cells||Standard Deviation|Mean
1233923|NCT00630539|Secondary|Mean Change From Baseline in Sex Hormone Binding Globulin Levels||Week 12|ITT|||nmol/L||Standard Deviation|Mean
1233924|NCT00630539|Secondary|Mean Change From Baseline in Follicle Stimulating Hormone Levels||Week 12|ITT|||U/L||Standard Deviation|Mean
1233925|NCT00630539|Secondary|Mean Change From Baseline in Luteinizing Hormone Levels||Week 12|ITT|||U/L||Standard Deviation|Mean
1233926|NCT00630539|Secondary|Mean Change From Baseline in Estradiol Levels||Week 12|ITT|||nmol/L||Standard Deviation|Mean
1233927|NCT00630539|Secondary|Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index||Week 4|ITT|||percentage of superficial cells||Standard Deviation|Mean
1233928|NCT00630539|Secondary|Mean Change From Baseline in Vaginal pH||Week 4|ITT|||pH||Standard Deviation|Mean
1233929|NCT00630539|Secondary|Visual Evaluation of Vagina (by Gynecological Examination)||Screening & Week 12|ITT|||percentage of subjects|||Number
1233930|NCT00630539|Primary|Mean Change From Baseline in Vaginal pH||12 weeks|ITT|||pH||Standard Deviation|Mean
1233931|NCT00630539|Primary|Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear||12 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
1233932|NCT00630539|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear||12 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
1233934|NCT00630487|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)|Participant self-administered questionnaire EQ-5D, a 2 part generic health status instrument. The first part consists of 5 descriptors of current health state: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Scores are assigned on a three-level scale (1= no problem, 2= some problem, 3= extreme problem). The second part was an overall rating of the participant's current health state using a 20 cm Visual Analogue Scale (EQ-VAS) with endpoints labelled ‘best imaginable health state’ and ‘worst imaginable health state’.|Baseline, Week 52, Week 78|||||||
1233935|NCT00630487|Secondary|Change From Baseline in Short Form (36) Health Survey (SF36)|Participant self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT). Scale range 0 to 100, higher scores indicate a better health-related quality of life.|Baseline, Week 52, Week 78|||||||
1233936|NCT00630487|Secondary|Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)|Participant self administered questionnaire consisting of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life.|Baseline, Week 52, Week 78|||||||
1233937|NCT00630487|Secondary|Change From Baseline in Homeostasis Model Assessment (HOMA)-Index|HOMA index is calculated by 1 of 2 methods: HOMA-Index = fasting insulin measured in microunits per milliliter (µU/ml) times fasting glucose measured in milligrams per deciliter mg/dl) divided by 405 or HOMA-Index = fasting insulin (µU/ml) times fasting glucose measured in millimoles per liter (mmol/l) divided by 22.5.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
1233938|NCT00630487|Secondary|Change From Baseline in Safety Laboratory Assessments|Prespecified safety laboratory assessments evaluated for change or no change from baseline. Possible responses were Yes/No.|Baseline, Week 52, Week 78|||||||
1233939|NCT00630487|Secondary|Change in Executive Function and Memory in Subgroups|Change in executive function and memory in subgroups. Subgroup 1: isolated Growth Hormone Deficiency (GHD)due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH). Median reaction time, the total number of errors, the number of omissions and the number of false positive reactions.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
1233940|NCT00630487|Secondary|Change From Baseline in Heart Rate|The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
1233941|NCT00630487|Secondary|Change From Baseline in Blood Pressure|Blood pressure was measured seated, the subject's arm supported at the level of the heart, and recorded to the nearest mm Hg. The same arm (preferably the dominant arm) was used throughout the trial. The subject was seated for 5 minutes before the blood pressure was obtained. Use of an automated device could have been used for measuring blood pressure.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
1233942|NCT00630487|Secondary|Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])|Alertness: software-based neuropsychological assessment for response time and errors. Memory: analysis of learning and retention using 5-trial presentation of 15-word list (A), single presentation of interference list (B), 2 postinterference recall trials - 1 immediate, 1 delayed - and recognition of the target words with distractors (C). Performance variables were immediate word span under overload conditions, final acquisition level, amount learned in 5 trials, interference, delayed recall, and recognition (implicit learning).|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
1233943|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Waist Circumference)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.||||||
1233944|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Weight)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.||||||
1233945|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Height)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.||||||
1233946|NCT00630487|Secondary|Change in Visceral Fat Mass in Subgroups|Change in visceral fat mass in subgroups. Subgroup 1: isolated GHD due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).|Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.||||||
1233947|NCT00630487|Primary|Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)|Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.|Baseline, 52 weeks|Study terminated, no subjects were treated.||||||
1233948|NCT00630409|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 40 months|Due to lack of follow-up, objective could not be determined.|||participants||95% Confidence Interval|Median
1233949|NCT00630409|Primary|Response Rate|Number of participants that experienced response/total number of participants per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Response was defined as Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), a 30% or greater decrease in the sum of the longest diameter of target lesions.|Up to 18 weeks for individual; Up to 40 months for cohort||||percentage of participants|||Number
1233986|NCT00629772|Secondary|Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26.~0 = clear~1 = almost clear~2 = Mild~3 = Moderate~4 = Severe~5 = Very severe"|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percent improvement||Standard Deviation|Mean
1233950|NCT00630396|Secondary|90 Day Modified Rankin Scale Score|The modified Rankin Scale (mRS) was performed in person at the 90 day clinic follow-up appointment. The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6. 0 represents no symptoms. 1 represents no significant disability. 2 represents slight disability. 3 represents moderate disability. 4 represents moderately severe disability. 5 represents severe disability. 6 represents death.|3 months||||Participants|||Number
1233951|NCT00630396|Secondary|Half-life of IV Minocycline|In eligible patients enrolled at Georgia Health Sciences University, blood samples were drawn for quantification of minocycline serum concentrations. This enabled the study team to determine the half life of the study drug.|For each subject blood samples were drawn before dose #1 and one hour after starting dose #1. Additional blood was drawn 1, 6, 12, 24, 48, and 72 hours after starting dose #6, which lasted approximately 6 days.||||hours|Participants|Standard Error|Mean
1233952|NCT00630396|Primary|Maximally Tolerated Dose of IV Minocycline|Investigators closely monitored each subject for evidence of minocycline intolerance. All adverse events were immediately reported for a decision whether to discontinue the study medication and/or reduce the dose. A computer program was used to determine the maximum tolerated dose. After entering information regarding doses and expected toxicities, results for each subject as they were collected were entered. The computer program informed as to (de)escalation, or maintenance of the same dose in the subsequent cohort of enrolled patients.|3 days||||mg/kg|||Number
1233953|NCT00630344|Secondary|Time to Progression (TTP)|TTP estimated with Kaplan-Meier methods is defined as the time from treatment start to when PSA progression criteria is first met, or the date of measurable or non-measurable disease progression (PD). Absent progression, patients are censored at the date of the last PSA measurement. PSA progression is a ≥25% increase over baseline or nadir PSA, whichever is lowest with a minimum increase of 5 ng/mL. If PSA declines ≥50%, PSA progression is a ≥50% PSA increase above nadir with a minimum increase of 5 ng/mL or back to pretreatment baseline, whichever is lowest. PSA progression requires 2 week confirmation. Per RECIST, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. Non-measurable PD is defined as a worsening bone scan, as indicated by the appearance of two or more new lesions, the appearance of new non-bony metastases or a requirement for radiation therapy.|PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year.|The analysis dataset is comprised of all treated patients.|||weeks||Full Range|Median
1233954|NCT00630344|Secondary|Incidence of Grade 1-3 Treatment-Related Fatigue Toxicity|All grade 1-3 fatigue adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 fatigue AE during the time of observation.|Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
1233955|NCT00630344|Secondary|Incidence of Grade 1-3 Treatment-Related Rash Toxicity|All grade 1-3 rash adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 rash AE during the time of observation.|Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
1233956|NCT00630344|Secondary|Incidence of Grade 1-3 Treatment-Related Mucositis Toxicity|All grade 1-3 mucositis adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 mucositis AE during the time of observation.|Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
1233957|NCT00630344|Secondary|Incidence of Grade 4 Treatment-Related Toxicity|All grade 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 4 AE of any type during the time of observation.|Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
1233958|NCT00630344|Primary|Overall Response Rate|"Overall response rate is the percentage of patients achieving response taking into consideration measurable disease, bone metastases, and PSA. PSA declines in the absence of both measurable disease and the appearance of new bone lesions or a response in measurable disease without an increase in PSA or the appearance of new bone lesions. Patients with stable disease (SD) lasting at least 6 months will also be considered responders.~Per RECIST guidelines, for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation is required within 4 weeks. Per modified PSAWG2 criteria (Scher H, Halabi S, Tannock I et al. JCO 2008) PSA response is defined as PSA decline ≥ 50% from baseline confirmed by a second measurement at least 4 weeks later."|PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year.|The analysis dataset is comprised of all treated patients.|||percentage of patients||90% Confidence Interval|Number
1233959|NCT00630331|Secondary|Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination|The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.|Up to 7 days post vaccination|Analysis was done on Safety population i.e. all subjects in the exposed population who provide post vaccination safety data.|||Subjects|||Number
1233999|NCT00629525|Secondary|Pathologic Response|Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index|Patients were followed for a median of 315 days|Only subjects with paired samples were included in this analysis|||participants|||Number
1233960|NCT00630331|Secondary|Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo|As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.|Three weeks after vaccination (day 22)|Analysis was done on a subset of subjects who constituted the PP immunogenicity population.|||Percentages of subjects||95% Confidence Interval|Number
1233961|NCT00630331|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo|Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.|Before vaccination (day 1) and three weeks after vaccination (day 22)|Analysis was done on a subset of subjects who constituted the PP immunogenicity population.|||Percentages of subjects||95% Confidence Interval|Number
1233962|NCT00630331|Secondary|Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done on PP efficacy population.|||Numebr of Days of Usual Activity Lost||Standard Deviation|Mean
1233963|NCT00630331|Secondary|Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done on PP efficacy population.|||Numebr of Days of Usual Activity Lost||Standard Deviation|Mean
1233964|NCT00630331|Secondary|Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done of PP efficacy population.|||Number of Medical Visits||Standard Deviation|Mean
1233965|NCT00630331|Secondary|Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done of PP efficacy population.|||Number of Medical Visits||Standard Deviation|Mean
1233966|NCT00630331|Secondary|Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done on PP efficacy population.|||Number of Days||Standard Deviation|Mean
1233967|NCT00630331|Secondary|Influenza-Associated Days in Bed, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done on the PP efficacy population.|||Number of Days||Standard Deviation|Mean
1233968|NCT00630331|Secondary|Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.|6 Months|Analysis was done on PP efficacy population.|||Subjects|||Number
1233969|NCT00630331|Secondary|Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.|6 Months|Analysis was done on PP efficacy population.|||Subjects|||Number
1233970|NCT00630331|Primary|Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.|6 Months|Analysis was performed on per protocol (PP) efficacy population i.e. the subjects in the exposed efficacy population who correctly received the vaccine and provided evaluable swab samples at the relevant time points.|||Subjects|||Number
1233971|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session D- Closed Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
1233985|NCT00629772|Secondary|Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26|Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles.|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percent improvement||Standard Deviation|Mean
1234000|NCT00629525|Primary|Biochemical Response Rate|Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.|Patients were followed for a median of 315 days||||participants|||Number
1233972|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session C- Open Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
1233973|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session B- Closed Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
1233974|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session A- Open Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percent Difference of Bleb Area|Subjects Eyes|Standard Deviation|Mean
1233975|NCT00630292|Primary|Amount of Blood Vessel Tortuosity in Breast With Known Cancer|Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy|up to two weeks prior to start of chemotheraphy|Blood vessels could not be detected for any of the subjects due to spatial resolution limits of MRI scanner for breast MRI and therefore measurement of blood vessel angularity could not be performed.|||sum of blood vessel angles|||Number
1233976|NCT00630058|Secondary|Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels|HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2–7.8 log10 IU/mL.|37 weeks||||Log IU / mL||Standard Deviation|Mean
1233977|NCT00630058|Primary|T1/2(Time of Half-Life) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||hours||Standard Deviation|Mean
1233978|NCT00630058|Primary|Ctrough (Minimum Observed Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||μg/mL||Standard Deviation|Mean
1233979|NCT00630058|Primary|AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||μg/mL||Standard Deviation|Mean
1233980|NCT00630058|Primary|Tmax (Time of Maximum Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||hours||Full Range|Median
1233981|NCT00630058|Primary|Cmax (Maximum Observed Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||μg/mL||Standard Deviation|Mean
1233982|NCT00629850|Primary|Change in Negative Inspiratory Force Using a Pressure Manometer||10 weeks|there was only one participant completing this study. No analyses performed.|||cmH2O|||Number
1233983|NCT00629850|Primary|Change in Maximum Voluntary Ventilation Using Pulmonary Function Device|pulmonary function device measures flow rate in liters per minute|10 weeks|there was only one participant completing this study. No analyses performed.|||liter per minute|||Number
1233984|NCT00629850|Primary|Number of Participants With Improvement in Sleep Quality.|Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.|10 weeks|There was only one participant completing the study. No analyses performed.|||participants|||Number
1234001|NCT00629499|Secondary|Overall Survival||18 Months|||||||
1234002|NCT00629499|Secondary|Disease-free Survival||18 Months|||||||
1233987|NCT00629772|Secondary|Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26.~Impact on quality of life with the DLQI. The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.~0-1 = no effect at all on patient's life~2-5 = small effect on patient's life~6-10 = moderate effect on patient's life~11-20 = very large effect on patient's life~21-30 = extremely large effect on patient's life"|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percent improvement||Standard Deviation|Mean
1233988|NCT00629772|Secondary|Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26.~m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percent improvement||Standard Deviation|Mean
1233989|NCT00629772|Secondary|Mean Physician's Global Assessment (PGA) at Week 14|"Efficacy by comparing the mean Physician's Global Assessment(PGA).~0 = clear.~1 = almost clear.~2 = Mild.~3 = Moderate.~4 = Severe.~5 = Very severe."|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1233990|NCT00629772|Secondary|Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14|Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected).|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percentage of affected area||Standard Deviation|Mean
1233991|NCT00629772|Secondary|Mean Dermatology Life Quality Index (DLQI) at Week 14|"Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.~0-1 = no effect at all on patient's life~2-5 = small effect on patient's life~6-10 = moderate effect on patient's life~11-20 = very large effect on patient's life~21-30 = extremely large effect on patient's life"|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1233992|NCT00629772|Secondary|Number of Adverse Events at Week 14|Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events|14 weeks||||Adverse Events|||Number
1233993|NCT00629772|Primary|75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0|"Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|14 weeks|The analysis was performed on the intent to treat (ITT) population. Nonresponder imputation (NRI) was used for patients who withdrew before the end of the study. They were treated as nonresponders from the point of withdrawal onward.|||Participants|||Number
1233994|NCT00629707|Secondary|Brain NAA/Creatine Ratio & Brain Lactate Measured by MR Spectroscopy, Cerebral Blood Flow & Oxygen Saturation Measured by MR Perfusion Weighted Imaging & Near Infrared Spectroscopy, Mental Status Evaluated by Glasgow Coma Scale Scores.||twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment|||||||
1233995|NCT00629707|Primary|Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)|In both groups, brain Apparent Diffusion Coefficient (ADC) measures at 3-6 hours and 9-12 hours after beginning DKA treatment were averaged to determine overall brain ADC during DKA treatment. The brain ADC indicates the distribution of water in the brain and is an indicator of brain swelling (edema). The overall brain ADC values during DKA treatment were compared with the brain ADC measured after recovery to assess the degree of brain edema formation during DKA treatment. The difference in brain ADC, calculated as the averaged treatment values minus the recovery value, was used as the main outcome measure to indicate the degree of brain edema formation|twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment|Data from all enrolled participant that completed the study were analyzed.|||mm^2/sec||Standard Deviation|Mean
1233996|NCT00629525|Secondary|Clinical Response|"The percentage of participants with a complete or partial response as defined by RECIST 1.0. Response Criteria are defined below:~Complete Response: Disappearance of all target lesions Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD"|Patients were followed for a median of 315 days||||participants|||Number
1233997|NCT00629525|Secondary|Molecular Response|Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.|Patients were followed for a median of 315 days|Immunohistochemistry (IHC) for pS6 was compared for 9 pairs of samples for which paraffin embedded tissue was available.|||percentage of decrease||Full Range|Mean
1234004|NCT00629265|Secondary|Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)|"Perceive improved in quality of life and eating ability as measured by 2 validated scales: the Performance Status Scale for Head and Neck Cancer Patients (PSS) and The Head and Neck Cancer Inventory (HNCI).~The PSS (List, et. al., 1990) is a clinician adminsitered scale that has three domains (normalcy of diet, eating in public, and understandability of speech). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best.~The HNCI (Funk, et. al., 2003) is patient administered questionnaire that has four domains (social disruption, aesthetics, speech, eating). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best."|Before and after treatment|Note: the number of participants analyzed (126) does not match the total number enrolled (170) because 44 people did not have adequate follow up data required for this secondary analysis.|||Change in PSS and HNCI score||Standard Deviation|Mean
1234005|NCT00629265|Primary|Change in Penetration-Aspiration Scale (PAS) Score|"The PAS scale is a validated 8-point ordinal scale (Rosenbek et. al 1996) in which a score of 1 is best (material does not enter the airway) and a score of 8 is worst (material enters the airway, passes below the vocal folds, and no effort is made to eject it).~Difference in mean PAS scores after 12 weeks of therapy was analyzed between the two groups of interest: Active NMES + Swallowing Exercise versus Sham (inactive) NMES + Swallowing Exercise. PAS scores were obtained from fluoroscopy (modified barium swallow) studies adminstered at three time points - enrollment, midway through treatment (6 weeks), and at end of treatment (12 weeks). All fluoroscopy studies were sent to, and analyzed by, a blinded external central laboratory."|Before and after treatment|Note: the number of participants analyzed (125) does not match the total number enrolled (170) because 45 people did not have adequate follow up data required for this primary analysis.|||Change in points on PAS||Standard Deviation|Mean
1234006|NCT00629239|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 4 weeks of treatment||||meter||Full Range|Mean
1234007|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score|Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment||||Scores on a scale||Full Range|Mean
1234008|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment||||Scores on a scale||Full Range|Mean
1234009|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment||||Score on a scale||Full Range|Mean
1234010|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment||||Scores on a scale||Full Range|Mean
1234011|NCT00629239|Secondary|The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||Score on a scale||Full Range|Mean
1234012|NCT00629239|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
1234013|NCT00629239|Secondary|Peak Expiratory Flow (PEF) Morning|Change from average during run-in to average during treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
1234014|NCT00629239|Secondary|Forced Expiratory Flow (FEF) 25%-75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L/s||Full Range|Mean
1234015|NCT00629239|Secondary|Inspiratory Capacity (IC)|Change from IC baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L||Full Range|Mean
1234016|NCT00629239|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L||Full Range|Mean
1234017|NCT00629239|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L||Full Range|Mean
1234018|NCT00629239|Secondary|Forced Expiratory Volume 1 (FEV1)|Change in (FEV1) from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L||Full Range|Mean
1234019|NCT00629239|Primary|Number of Patients Experiencing Adverse Events|Number of patients who had an Adverse Event|At all study visits||||Participants|||Number
1234020|NCT00629122|Secondary|Drug Interactions and Genotypes|Impact of drug interaction between tacrolimus and clotrimazole troche vs. nystatin suspension. Evaluate genotype polymorphisms that influence CYP3A4, CYP3A5, and p-glycoprotein expression to determine impact on sublingual and oral tacrolimus delivery.|2 weeks|We were unable to assess genotype polymorphisms due to the small number of subjects enrolled in the study.||||||
1234021|NCT00629122|Primary|Tacrolimus Powder Dissolution Time|Tacrolimus Powder Dissolution Time during Sublingual Administration (minutes)|Day 3, minutes to powder dissolution||||minutes||Full Range|Median
1234022|NCT00629122|Primary|Estimated AUC 0-6|Area Under the Concentration-Time Curve from 0-6 hours (mg-hr/L)|Day 3 and Day 8, calculated based on concentrations measured between hours 0 and 6|"Where 0 is entered, the patient did not receive that combination (ie. was in other arm)"|||mg-hr/L|||Number
1234023|NCT00629122|Primary|Tmax|Time to Maximum concentration (hours)|Day 3 and Day 8, time of maximum concentration||||hours||Full Range|Median
1234024|NCT00629122|Primary|Cmax|Maximum concentration (ng/mL)|Day 3 and Day 8, at time of maximum concentration||||ng/mL||Full Range|Median
1234025|NCT00629122|Primary|C0 (ng/mL)|Trough concentration|Day 3 and Day 8, time 0 (before tacrolimus dose)||||ng/mL||Full Range|Median
1234026|NCT00629018|Secondary|Changes in Left Ventricular Function||5 years|||||||
1234027|NCT00629018|Secondary|Changes in Plasma Inflammatory Markers||6 months|||||||
1234028|NCT00629018|Secondary|Changes in Electrophysiologic Properties of Ventricular Myocardium||6 months|||||||
1234029|NCT00629018|Secondary|Changes in Exercise Capacity||5 years|||||||
1234032|NCT00628927|Secondary|Tail Length From the Comet Assay for Oxidative Damage|The test for oxidative damage was derived from a blood sample which was analyzed for tail length from the comet assay; higher scores reflect greater oxidative damage.|Single study visit||||µm||Standard Deviation|Mean
1234033|NCT00628927|Secondary|Barrett Impulsiveness Scale Version 11 (BIS-11)|"The BIS-11 consists of 30 self-report items, with responses in a four-point Likert-type scale (0 - 3)ranging from Rarely/Never to Almost Always/Always and comprises three domains: Attentional impulsiveness (AI), Motor impulsiveness (MI), and Non-planning impulsiveness (NP); these three domains are summed to yield a total score; higher scores reflect greater impulsivity. The total score was utilized as the BIS-11 predictor measure (possible score range 0 - 90)."|Single study visit||||units on a scale||Standard Deviation|Mean
1234034|NCT00628927|Primary|Stroop Color-word Task|The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ‘‘red’’ might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial.|Single study visit||||seconds||Standard Deviation|Mean
1234035|NCT00628901|Secondary|Health Related Quality of Life Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|12 months||||Scores on a scale||Standard Deviation|Mean
1234036|NCT00628901|Secondary|Health Related Quality of Life Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|3 months||||Scores||Standard Deviation|Mean
1234037|NCT00628901|Secondary|Health Related Quality of Life (HRQL)Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|Baseline||||Scores on a scale||Standard Deviation|Mean
1234038|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100.The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)."|12 months||||Scores on a scale||Standard Deviation|Mean
1234039|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)"|3-months||||Scores on a scale||Standard Deviation|Mean
1234040|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)"|Baseline||||Scores on a scale||Standard Deviation|Mean
1234041|NCT00628901|Secondary|Any Adverse Events That the Participant Experienced|Summary of investigator reported adverse events and adverse device effects, including all serious adverse events and unanticipated adverse device effects. Adverse events were collected systematically, meaning they were collected during the participant's follow-up visit, during telephone contacts, or during medical record review.|During the hospitalization stay post UFE||||events|||Number
1234042|NCT00628901|Secondary|Procedure Time|Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding)|During the study procedure (measured in minutes)||||minutes||Standard Deviation|Mean
1234043|NCT00628901|Secondary|Fluoroscopy Time|Fluoroscopy is the method that provides real-time X ray imaging used for guiding a variety of diagnostic and interventional procedures. Fluoroscopy time is described as the amount of time the patient underwent fluoroscopy.|During the study procedure (measured in minutes)||||minutes||Standard Deviation|Mean
1234079|NCT00628251|Secondary|Confirmed RECIST Response and/or CA-125 Response|The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Percentage of participants|||Number
1234044|NCT00628901|Secondary|Visual Analog Scale (VAS) Maximum Level of Pain|Maximum level of pain was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no pain' and the right side (10cm) of the line represents 'worst imaginable'. The patient is asked to place a mark on the line that represents their level of pain. For example, a reading of 10cm = worst imaginable pain.|24 hours after study procedure||||cm||Standard Deviation|Mean
1234045|NCT00628901|Secondary|Visual Analog Scale (VAS) Maximum Level of Nausea|Maximum level of nausea was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no nausea' and the right side (10cm) of the line represents 'worst nausea imaginable'. The patient is asked to place a mark on the line that represents their level of nausea. For example, a reading of 10cm = worst nausea imaginable.|24 hours after study procedure||||cm||Standard Deviation|Mean
1234046|NCT00628901|Primary|Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)|MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).|24-hours post study procedure||||participants|||Number
1234047|NCT00628862|Secondary|St George’s Respiratory Questionnaire (SGRQ)|Patients were asked to complete the St George’s Respiratory Questionnaire (SGRQ). Subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life. A score of 0 indicates the best possible status. Results are expressed as the change from baseline score with a decrease in score indicating improvement.|12 weeks (end of run-in to last visit)||||Scores on a scale||Standard Deviation|Mean
1234048|NCT00628862|Secondary|Use of Reliever Medication|Patients were asked to record reliever medication use. Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|12 weeks (end of run-in to last visit)||||medication doses per day||Standard Deviation|Mean
1234049|NCT00628862|Secondary|Cough|Patients were asked to record cough (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks||||scores on a scale per day||Standard Deviation|Mean
1234050|NCT00628862|Secondary|Breathlessness|Patients were asked to record breathlessness (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks||||scores on a scale per day||Standard Deviation|Mean
1234051|NCT00628862|Secondary|Change in Night-time Awakenings Due to Symptoms|Patients were asked to record the night-time awakenings due to symptoms (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks||||scores on a scale per day||Standard Deviation|Mean
1234052|NCT00628862|Secondary|Change in Peak Expiratory Flow (PEF), Evening|Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the evening). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period and 12 week||||L/min||Standard Deviation|Mean
1234053|NCT00628862|Secondary|Change in Peak Expiratory Flow (PEF), Morning|Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the morning). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period and 12 week||||L/min||Standard Deviation|Mean
1234054|NCT00628862|Secondary|FVC 5 Minutes Post-dose|Lung function (FVC) was measured 5 minutes after the first dose of study drug, The results are expressed as a percentage in relation to the baseline value|baseline and 5 minutes anter first dose||||percent of baseline||Full Range|Geometric Mean
1234055|NCT00628862|Secondary|FEV1 5 Minutes Post-dose|Lung function (FEV1) was measured 5 minutes after the first dose of study drug. The results are expressed as a percentage in relation to the baseline value|baseline and 5 minutes anter first dose||||percent of baseline||Full Range|Geometric Mean
1234056|NCT00628862|Secondary|FVC Pre-dose|Lung function (FVC) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value|baseline at week 0 and pre-dose at weeks 4, 8 and 12||||percent of baseline||Full Range|Geometric Mean
1234057|NCT00628862|Secondary|FEV1 Pre-dose|Lung function (FEV1) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value|baseline at week 0 and pre-dose at weeks 4, 8 and 12||||percent of baseline||Full Range|Geometric Mean
1234058|NCT00628862|Secondary|Forced Vital Capacity (FVC) 60 Minutes Post-dose|Forced Vital Capacity (FVC) is a spirometric measure of lung function. FVC was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value|from baseline up to 12 weeks||||percent of baseline||Full Range|Geometric Mean
1234059|NCT00628862|Primary|Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose|FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.|from baseline up to 12 weeks||||percent of baseline||Full Range|Geometric Mean
1234060|NCT00628758|Secondary|Mean Use of As-needed Medication Per Day During Treatment Period|Mean use of as-needed medication per day during treatment period|Daily recording during the treatment period of 26 weeks|ITT analysis was performed. Being in line with the analysis description population and due to description of the variable which was based on the patient’s estimate, this variable could only be calculated of the patients who had recorded at least one estimate on their dairies they had been asked to return to the investigator at the study visits.|||inhalations per day||Standard Deviation|Mean
1234061|NCT00628758|Secondary|Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score|Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.|Baseline and 26 weeks|ITT analysis was performed. Being in line with the analysis description population and due to the description of the variable. This patient-reported outcome variable could only be calculated for patients who have baseline and visit 4 AQLQ data. The AQLQ was not filled in by all enrolled patients.|||Units on a scale||Standard Deviation|Mean
1234062|NCT00628758|Secondary|Number of Severe Asthma Exacerbations|Total number of severe asthma exacerbations per treatment group|26 weeks||||Severe Exacerbations|||Number
1234063|NCT00628758|Primary|Time to First Severe Asthma Exacerbation|Time to severe exacerbation among patients|26 weeks||||days||Standard Deviation|Mean
1234064|NCT00628628|Primary|Number of Participants With Plasma Uric Acid (UA) Response|Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.|First cycle of chemotherapy, up to 5 days||||participants|||Number
1234065|NCT00628589|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|Baseline and 2 hours|ITT Population with LOCF|||Participants|||Count of Participants
1234066|NCT00628589|Secondary|Clinical Global Impression-Improvement (CGI-I) Score|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
1234067|NCT00628589|Primary|Change in PANSS-EC From Baseline|The Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
1234068|NCT00628498|Primary|Survival by Day+100 Post Stem Cell Transplant or Chemotherapy||Day +100 from HSCT or 100 days from start of chemotherapy|ITT Efficacy Population|||Percentage of participants alive||95% Confidence Interval|Number
1234069|NCT00628446|Secondary|Adherence to NCEP Criteria|Determine the total percentage of subjects who should be on drug therapy by NCEP criteria and who are on drug therapy who have achieved their treatment goal as defined by NCEP criteria|During single data collection|38 subjects completed the data collection|||percentage of participants|||Number
1234070|NCT00628446|Primary|Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines|Participants were classified as high risk, intermediate high risk, intermediate low risk, and low risk based upon both their CCS and their LDL using NCEP Adult Treatment Panel III Guidelines. Those with CCS >/-400 were considered high risk, CCS=100-399 were intermediate high risk, CCS=1-99 intermediate low risk, and CCS=0 were low risk. The percent agreement between CCS and NCEP Guidelines was calculated by totaling the number of subjects who were classified in the same risk category and dividing by the total number of subjects|During single data collection. Average duration of injury was 24.4 years +/-9.5 years||||percent agreement|||Number
1234071|NCT00628407|Primary|Sternal Force Associated With Change in Intrathoracic Pressure.|The mean sternal force (measured in kg as a surrogate for Newtons [1kg = 9.81 newtons]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.|per case||||kg||Standard Deviation|Mean
1234072|NCT00628355|Primary|Clinical Response Rate|We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement.|immediately, 1, 3 months after treatment||||percentage of participants|||Number
1234073|NCT00628355|Primary|Intensity of Pain|"The pain will measured by using the visual analogue scale, that is represented by a straight line of 100mm starting at absence of pain and ending at point worst pain experienced or imagined."|immediately, 1, 3 months after treatment||||millimeters||Standard Deviation|Mean
1234074|NCT00628251|Secondary|Best QoL Response for FACT-O Symptom Index (FOSI)|Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for FOSI at baseline|||Number of patients|||Number
1234075|NCT00628251|Secondary|Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for FACT-O at baseline|||Number of patients|||Number
1234076|NCT00628251|Secondary|Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)|Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for TOI at baseline|||Number of patients|||Number
1234077|NCT00628251|Secondary|Overall Survival (OS)|OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals|At the time of the cut-off for the final analysis of overall survival (30 April 2010)||||Number of deaths|||Number
1234078|NCT00628251|Secondary|Disease Control Rate|The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Participants|||Number
1234081|NCT00628251|Secondary|Best Percentage Change in Tumour Size|The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Percent change||Full Range|Median
1234082|NCT00628251|Secondary|Duration of Response|The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Duration of response is analysed for patients experiencing a response.|||Months||95% Confidence Interval|Median
1234083|NCT00628251|Secondary|Objective Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumours - RECIST)|ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Number of responders|||Number
1234084|NCT00628251|Primary|Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])|PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)|Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)||||Number of patients that progressed|||Number
1234085|NCT00628212|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg*h / dL||Standard Error|Least Squares Mean
1234086|NCT00628212|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg / dL||Standard Error|Least Squares Mean
1234087|NCT00628212|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||mg / dL||Standard Error|Least Squares Mean
1234088|NCT00628212|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||Percent||Standard Error|Least Squares Mean
1234089|NCT00628147|Secondary|Procedure Complications||procedure and post-procedure complications within 30 days after colonoscopy||||Participants|||Count of Participants
1234090|NCT00628147|Secondary|Completion of Examinations||same day||||Participants|||Count of Participants
1234091|NCT00628147|Secondary|Neoplasm Detection Rates||same day|We report overall neoplasia detection rate, and then report a sub-analysis for the neoplasia detection rates by indication (screening vs non-screening).|||Participants|||Count of Participants
1234092|NCT00628147|Primary|Neoplasm Miss Rate||same day||||Miss rate percentage||95% Confidence Interval|Number
1234093|NCT00628134|Secondary|Peripheral Lung Dose|Change over 30 minutes in the percentage of the total deposited aerosol dose found in the peripheral lung zone. We are reporting the %peripheral dose at t=30 minus the %peripheral dose at t=0. This dose is determined based on measured radioactive counts after aerosol delivery, using nuclear medicine gamma camera images. The central lung zone is defined as a rectangle with 1/2 the height and 1/2 the width of a rectangle that surrounds the right whole lung. The peripheral zone is the portion of the lung image not included in the central lung zone.|30 minutes after delivery||||percentage of lung dose||Standard Deviation|Mean
1234094|NCT00628134|Primary|Uniformity of Aerosol Distribution|Measured change in central/peripheral (c/p) dose ratio over a 30 minute period after aersol delivery (c/p at t=30 - c/p at t=0). Central and peripheral lung doses are measured as radioactive counts depicted on nuclear medicine gamma camera images after radioisotope aerosol delivery. The central lung zone is a rectangle with 1/2 the height and 1/2 the width of a box outlining the whole right lung. The peripheral lung zone is defined as the portion of the lung outside of the central lung zone. A change in c/p ratio over time would indicate transport of material from one lung zone to the other. The variable represents the realtive proportion of airways dosing to alveolar dosing - an indication of deposition uniformity in the lungs.|30 minutes||||ratio||Standard Deviation|Mean
1234095|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||micromole per liter [μmol/L]||Full Range|Median
1234096|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||millimole per liter [mmol/L]||Full Range|Median
1234100|NCT00628108|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1234101|NCT00628108|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 3 (Day 7)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|7 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1234102|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1234103|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval|The QT interval refers to the respective time in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1234104|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration|The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1234105|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval|The PR interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1234106|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval|The RR interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1234107|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
1234108|NCT00628030|Secondary|Parental Dietary Intake of Fat|Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.|Baseline, Posttest||||grams||Standard Deviation|Mean
1234109|NCT00628030|Secondary|Parental BMI|Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.|Baseline, Posttest||||kg/m^2||Standard Deviation|Mean
1234110|NCT00628030|Secondary|Child Quality of Life|"Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest~We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life.~We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales.~The current report did not provide subscores."|Basline, Posttest||||units on a scale||Standard Deviation|Mean
1234111|NCT00628030|Secondary|Child Feeding|"The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale concern about child's weight is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test)."|Basline, Posttest||||units on a scale||Standard Deviation|Mean
1234112|NCT00628030|Primary|Child BMI|Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.|Basline, Posttest||||percentile||Standard Deviation|Mean
1234113|NCT00627978|Primary|Axons With Abnormal Morphology|Digital photographs for morphometry were captured at a magnification of 8000–16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.|Baseline and Over 7 cycles of treatment, approximately 21 weeks||||percentage of axons|||Number
1234114|NCT00627926|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234125|NCT00627926|Secondary|Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.|Week 4|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234215|NCT00627393|Secondary|Donor Availability (Proportion of Scheduled Granulocyte Transfusion Days on Which Granulocytes Were Available)||Measured through study completion|The unit of analysis is patient-days where a granulocyte transfusion was scheduled.|||percentage of available granulocyte days|Participants||Number
1234115|NCT00627926|Primary|Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.|24 weeks after last planned dose of study treatment (up to Week 72)|The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234116|NCT00627926|Secondary|Fatigue Severity Scale (FSS) Total Score|FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue.|Baseline, Week 4, 12, 24, 36, 48, 72|"The FA set included all randomized subjects who received at least 1 dose of any study drug. Here n signifies those participants who were evaluable for this measure at given time points for each group, respectively."|||units on a scale||Standard Deviation|Mean
1234117|NCT00627926|Secondary|Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis|FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline.|Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)|"The FA set included all randomized subjects who received at least 1 dose of any study drug. Here number of participants analyzed signifies those subjects who were evaluable for FibroTest Analysis and n signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively."|||participants|||Number
1234118|NCT00627926|Secondary|Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels|Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.|Baseline up to Week 48|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234119|NCT00627926|Secondary|Number of Subjects With Viral Relapse Planned and Viral Relapse Actual|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.|After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).|||participants|||Number
1234120|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|24 weeks after last actual dose of study treatment (up to Week 72)|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234121|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|12 weeks after last planned dose of study treatment (up to Week 60)|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234122|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|End of treatment (up to Week 48)|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234123|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at Week 12|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|Week 12|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234124|NCT00627926|Secondary|Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.|Week 4 and Week 12|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234216|NCT00627393|Secondary|Serious Adverse Events in Granulocyte Donors||Measured at Week 1 after G-CSF administration|237 subjects consented to G-CSF and dexamethasone administration prior to granulocyte donation.|||participants|||Number
1234126|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at Week 72|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
1234127|NCT00627861|Secondary|Blood Pressure||all visits (weekly for 12 weeks)||||mm Hg|||Number
1234128|NCT00627861|Secondary|Plasma Renin Activity|The blood test, plasma renin activity or PRA, is being measured during the visits outlined.|screening, 4th, 6th, 7th, 9th, 10th, 11th, 12th weeks||||ng/mL/h|||Number
1234129|NCT00627861|Primary|Plasma Renin Concentration||5th, 6th, 7th, 9th, 10th, 11th, 12th weeks||||pg/mL|||Number
1234130|NCT00627705|Secondary|Glutathione (GSH) Metabolism Intermediates in Peripheral Blood||12 weeks|Data not collected. The measure was not analyzed. The lab was not able to measure Glutathione for the study.||||||
1234131|NCT00627705|Secondary|Sensory Profile Questionnaire (SPQ)||12 weeks|Data not collected. Measure not analyzed.||||||
1234132|NCT00627705|Secondary|Social Responsiveness Scale (SRS)|SRS total score (range 0-195); higher scores mean more social impairment|12 weeks|We analyzed subjects who had follow-up data available.|||SRS total score (range 0-195)||Standard Deviation|Mean
1234133|NCT00627705|Secondary|The Aberrant Behavior Checklist Total Score (ABC)|Total score was not analyzed since we analyzed the sub scales. Additionally, the authors of the instrument do not recommend analyzing the total score.|4, 8, and 12 weeks|Measure not analyzed.||||||
1234134|NCT00627705|Primary|Irritability Subscale of the Aberrant Behavior Checklist (ABC)|Aberrant Behavior Checklist (ABC) Irritability Subscale Score (range 0-45); higher scores mean higher irritability|baseline and 12 weeks|We analyzed subjects who had follow-up data available.|||Score (range 0-45)||Standard Deviation|Mean
1234135|NCT00627705|Primary|Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC)|Data not collected. The laboratory was not able to measure Glutathione levels.|12 weeks|Data not collected.||||||
1234136|NCT00627705|Primary|The Clinical Global Rating Scale (CGRS) Improvement Subscale Score|Score range 1-7 (lower score mean more improvement compared to baseline)|12 weeks|We analyzed subjects who had follow-up data available.|||score (range 1-7)||Standard Deviation|Mean
1234137|NCT00627705|Primary|Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES)|The Dosage Record and Treatment Emergent Symptom Scale (DOTES) provides information on the presence, frequency, and severity of side effects reported during the course of the trial.|4, 8, and 12 weeks|We analyzed subjects who had follow-up data available.|||participants|||Number
1234138|NCT00627679|Primary|Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).|8 hours||||min||Standard Deviation|Mean
1234139|NCT00627679|Primary|AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.|||pg*min/mL||Standard Deviation|Mean
1234140|NCT00627679|Primary|AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010|The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.|||pg*min/mL||Standard Deviation|Mean
1234141|NCT00627679|Primary|Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).|8 hours|Patients with available data at specified time points are included in the analysis population.|||min||Standard Deviation|Mean
1234142|NCT00627679|Primary|Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.|||pg/mL||Standard Deviation|Mean
1234143|NCT00627523|Secondary|Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24.|Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height[m])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.|Baseline, Months 3, 6, 12, 18, and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||Kg/m2||Standard Deviation|Mean
1234144|NCT00627523|Secondary|Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24.|Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.|Baseline, Months 3, 6, 12, 18, and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||Kg||Standard Deviation|Mean
1234167|NCT00627458|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 1, during the entire study period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1234217|NCT00627393|Secondary|Long-term Survival||Measured at Month 3|All randomized subjects.|||participants|||Number
1234145|NCT00627523|Secondary|Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24.|Head circumference SDS was calculated by means of the following formula = (Participant head circumference)–(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.|Baseline, Months 3, 6, 12, 18 and 24.|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||SDS||Standard Deviation|Mean
1234146|NCT00627523|Secondary|Head Circumference SDS at Months 3, 6, 12, 18 and 24.|Head circumference SDS was calculated by means of the following formula = (Participant head circumference)–(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.|Months 3, 6, 12, 18 and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||SDS||Standard Deviation|Mean
1234147|NCT00627523|Secondary|Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12.|BSID-II measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI score. Possible PDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||Units on a scale||Standard Error|Least Squares Mean
1234148|NCT00627523|Secondary|Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12.|The Bayley Scale of Infant Development (BSID-II) measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI score. Possible MDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||Units on a scale||Standard Error|Least Squares Mean
1234149|NCT00627523|Secondary|Change From Baseline in Growth Velocity SDS at Month 12.|The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) – (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant’s growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.|||SDS||Standard Error|Least Squares Mean
1234150|NCT00627523|Secondary|Change From Baseline in Height SDS at Month 12.|Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant’s height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.|||SDS||Standard Error|Least Squares Mean
1234165|NCT00627497|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of partipants who met all of the following criteria:~Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score – Post-treatment Score ≥ 15);~Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated);~No serious adverse event classified as “surgical treatment associated”;~No additional surgical procedure classified as “failure.”"|24 months after operation||||percentage of patients|||Number
1234218|NCT00627393|Secondary|Time to Negative Blood Culture for Participants With Positive Blood Culture at Baseline||Measured through Day 42|||||||
1234151|NCT00627523|Secondary|Change From Baseline in Growth Velocity SDS at Month 24.|The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) – (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant’s growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.|Baseline and Month 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.|||SDS||Standard Error|Least Squares Mean
1234152|NCT00627523|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.|Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant’s height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.|Baseline and Month 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.|||SDS||Standard Error|Least Squares Mean
1234153|NCT00627497|Secondary|Hospital Stay||At the time of discharge||||days||Standard Deviation|Mean
1234154|NCT00627497|Secondary|Blood Loss||At the time of operation||||ml||Standard Deviation|Mean
1234155|NCT00627497|Secondary|Operative Time||at the time of operation||||hrs||Standard Deviation|Mean
1234156|NCT00627497|Secondary|Success Rate of SF-36 Health Survey|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 PCS and MCS for DIAM Device vs. Single-Level Posterior Decompression were defined as: (Post Score - Pre Score) / Pre Score>= 20%. The success rates of SF-36 PCS and MCS for DIAM vs. Posterolateral Interbody Fusion were defined as: Post Score - Pre Score >= 0.|24 month after operation||||percentage of participants|||Number
1234157|NCT00627497|Secondary|General Health Status (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|24 month after operation||||Scores on a scale||Standard Deviation|Mean
1234158|NCT00627497|Secondary|Leg Pain Success Rate|Leg pain success rate is reported as the percentage of participants whose leg pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.|24 month after operation||||percentage of participant|||Number
1234159|NCT00627497|Secondary|Leg Pain|Numerical rating scales are used to evaluate leg intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” A patient’s total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).|24 month after operation||||units on a scale||Standard Deviation|Mean
1234160|NCT00627497|Secondary|Back Pain Success Rate|Back pain success rate is reported as the percentage of participants whose back pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.|24 month after operation||||percentage of participants|||Number
1234161|NCT00627497|Secondary|Back Pain|Numerical rating scales are used to evaluate back pain intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” A patient’s total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).|24 month after operation||||units on a scale||Standard Deviation|Mean
1234162|NCT00627497|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 month after operation||||percentage of particpants|||Number
1234163|NCT00627497|Secondary|Success Rate of Oswestry Diability Index Scores|Success rate of Oswestry Diability Index Scores is reported as the percentage of participants who met: Pre-treatment Score – Post-treatment Score ≥ 15.|24 month after operation||||percentage of participants|||Number
1234164|NCT00627497|Secondary|Oswestry Disability Index (ODI) Score|The self-administered Oswestry Disability Index (ODI) Questionnaire was used to assess patient pain and ability to function. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|24 month after operation||||Scores on a scale||Standard Deviation|Mean
1234166|NCT00627458|Secondary|Number of Subjects Reporting Concomitant Medications||During the 4-day (Days 0-3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1234219|NCT00627393|Secondary|Time to Negative Test for Fungal Antigenemia (e.g., Galactomannan Antigenemia Among Participants With Invasive Aspergillosis)||Measured at Days 7, 14, and 42|||||||
1234168|NCT00627458|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0–30) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1234169|NCT00627458|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0–3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.|||Participants|||Count of Participants
1234170|NCT00627458|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0–3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.|||Participants|||Count of Participants
1234171|NCT00627458|Secondary|Number of Subjects With a Vaccine Response to PT, FHA and PR|Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).|One month after the booster dose (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234172|NCT00627458|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1234173|NCT00627458|Secondary|Anti-poliovirus Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1234174|NCT00627458|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1234175|NCT00627458|Secondary|Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1234176|NCT00627458|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1234177|NCT00627458|Secondary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234178|NCT00627458|Secondary|Number of Seroprotected Subjects Against PT, FHA and PRN|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234179|NCT00627458|Secondary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234180|NCT00627458|Secondary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234210|NCT00627445|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
1234181|NCT00627458|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234182|NCT00627458|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1234183|NCT00627458|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1234184|NCT00627458|Primary|Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1234185|NCT00627458|Primary|Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1234186|NCT00627458|Primary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1234187|NCT00627458|Primary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1234188|NCT00627458|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1234189|NCT00627458|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1234190|NCT00627458|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1234191|NCT00627458|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1234192|NCT00627458|Primary|Number of Subjects With a Vaccine Response to PT, FHA and PR|Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234193|NCT00627458|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234194|NCT00627458|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234195|NCT00627458|Primary|Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234211|NCT00627406|Secondary|Pregnancy Rate||from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test||||participants|||Number
1234196|NCT00627458|Primary|Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234197|NCT00627458|Primary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234198|NCT00627458|Primary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234199|NCT00627458|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234200|NCT00627458|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234201|NCT00627458|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234202|NCT00627458|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Before the booster administration (At Month 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1234203|NCT00627445|Secondary|Number of Nocturnal Hypoglycaemic Episodes|Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1234204|NCT00627445|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1234205|NCT00627445|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to end of treatment (week 16)|week 0, week 16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.|||kg||Standard Error|Least Squares Mean
1234206|NCT00627445|Secondary|The Total Increase in Total Daily Insulin Dose Per Body Weight|The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).|week 0, week 16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.|||U/kg||Standard Error|Least Squares Mean
1234207|NCT00627445|Secondary|Change and Daily Average in Prandial Plasma Glucose Increment|Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
1234208|NCT00627445|Secondary|Change and Daily Average in 8-point Plasma Glucose|Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
1234209|NCT00627445|Secondary|The Percentage of Subjects Achieving HbA1c Treatment Targets|The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.|||percentage (%) of subjects|||Number
1234220|NCT00627393|Secondary|Fever Resolution|Fever resolution between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.|Measured through Day 42|Subjects who had fever at baseline.|||proportion of subjects, resolved fever|||Number
1234221|NCT00627393|Secondary|Overall Incidence of Adverse Effects||Measured through Day 42|All randomized subjects.|||participants|||Number
1234222|NCT00627393|Secondary|Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation|Time to GVHD incidence between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.|Measured at Day 42|Subjects who had allogeneic stem cell transplantation|||proportion of subjects, GVHD incidnence|||Number
1234223|NCT00627393|Secondary|Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)||Measured within 6 hours after end of transfusion|Subjects who received granulocyte transfusions. Six subjects in the control group received granulocyte transfusions in violation of the protocol.|||participants|||Number
1234224|NCT00627393|Secondary|Alloimmunization, Defined as the Appearance of Anti-human Leukocyte Antigen (HLA) or Antineutrophil Antibodies||Measured at Days 14 and 42|||||||
1234225|NCT00627393|Primary|Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response|"Microbial response was defined as follows:~A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia.~Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization."|Measured at Day 42|All adjudicated or deceased subjects in intention-to-treat analyses.|||percentage of participants|||Number
1234226|NCT00627367|Post-Hoc|Change in Numerical Rating Scale (NRS) Scores Among Patients in the Protocolized Group vs Those in the Physician Driven Group Who Received Only Intravenous (IV) Morphine|"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department). The comparison of hydromorphone to morphine is due to the wide use of morphine for pain management in the Emergency Department setting and the comparison of the two opioids in previous studies."|60 minutes|The Nonprotocolized group has a different value for participants analyzed for this section than the overall number of participants analyzed for the group (81 versus 110), because this is looking at only those patients who received IV morphine. Nonprotocolized left medication up to the doctor, and as such, some patients received different medication|||units on a scale||Standard Deviation|Mean
1234227|NCT00627367|Post-Hoc|Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 2 Doses of Intravenous (IV) Hydromorphone|"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department)."|60 minutes|Change in N from total analyzed (26 and 22 from 108 and 110 respectively) due to looking at a subpopulation: those patients who received 2 or more doses of IV hydromorphone, versus those who received only 1 dose (see 2. Post Hoc Outcome).|||units on a scale||Standard Deviation|Mean
1234228|NCT00627367|Post-Hoc|Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 1 Dose of Intravenous (IV) Hydromorphone|"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department)."|60 minutes|Change in N from total analyzed (82 and 99 from 108 and 110 respectively) due to looking at a subpopulation: those patients who only received 1 dose of IV hydromorphone, versus those who received 2 or more doses (see 3. Post Hoc Outcome).|||units on a scale||Standard Deviation|Median
1234229|NCT00627367|Primary|Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline.|"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department)."|60 minutes|Protocolized group had 4 missing outcome data, Nonprotocolized missing 2 outcome data. These 6 patients were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1234230|NCT00627094|Secondary|Adverse Events|Number of Adverse events reported which were evaluated to be related or possible related to the device|Continuously from start of treatment to end of trial (day 43)||||Number of AE|||Number
1234231|NCT00627094|Secondary|Change From Baseline in Ulcer Area|Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)|Change from baseline to end of trial (day 43)|ITT population|||Relative change from baseline in percent||Standard Deviation|Median
1234232|NCT00627094|Secondary|Pain Intensity (PI) Change|Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).|Change from baseline in Pain Intensity (PI) on day 4 evening|PP-population (The PP population consisted of all randomized subjects that fulfilled the inclusion/exclusion criteria and which did not violate the protocol in a serious way day 1-5) - Evaluation performed on un-blinded data before database lock.|||Change in PI since baseline||Standard Deviation|Mean
1234233|NCT00627094|Primary|Pain Relief|The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.|Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)|ITT population|||percentage of scores within category|Total Number of scores day 1-5||Number
1234259|NCT00626808|Primary|Geographic Region: Western|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234234|NCT00627042|Secondary|Number of Participants With Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered by the investigator to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 37.5 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.|||participants|||Number
1234235|NCT00627042|Secondary|Number of Participants With Serum Anti-Ramucirumab Antibodies||Prior to dosing at baseline, Cycles 4 and 7, and 30 days after end of therapy (1 cycle=2 weeks)|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.|||participants|||Number
1234236|NCT00627042|Secondary|Duration of Response|Duration of response was the interval from the date of initial documented response [complete response (CR) or partial response (PR)] to the first documented date of disease progression, initiation of other (or additional) antitumor therapy was first reported, or death due to any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR was the disappearance of all target lesions, PR was having at least a 30% decrease in the sum of the longest diameter of target lesions, and disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data were censored for participants who did not progress or die.|Time of first response (CR or PR) to disease progression, or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Participants who received at least 1 dose of ramucirumab and had a CR or PR. The number of participants censored 2.|||months||95% Confidence Interval|Median
1234237|NCT00627042|Secondary|Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). As classified according to Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR was the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions. PR was having at least a 30% decrease in sum of longest diameter of target lesions.|First dose to date of objective progressive disease (PD) or death up to 18 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.|||percentage of participants||95% Confidence Interval|Number
1234238|NCT00627042|Secondary|Overall Survival|Overall survival (OS) was the duration from first dose to death due to any cause. OS was censored at last contact date for participants who were alive at the end of follow-up period or lost to follow-up.|First dose to death due to any cause up to 37.5 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 10.|||months||95% Confidence Interval|Median
1234239|NCT00627042|Secondary|Time to Progression|The time from first day of therapy to the first date of objective evidence of progressive disease (PD) by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD was defined as having at least a 20% increase in sum of longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of new lesion. Time to PD was censored at the date of death or study discontinuation.|First dose to date of PD [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 20.|||months||95% Confidence Interval|Median
1234240|NCT00627042|Primary|Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer Treated With the Monoclonal Antibody Ramucirumab|PFS was defined as the time from the first day of therapy to the first evidence of disease progression or death from any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Participants who were alive and without disease progression and participants who did not progress and were subsequently lost to follow-up were censored at the last objective tumor assessment.|First dose to date of progressive disease or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 13.|||months||95% Confidence Interval|Median
1234241|NCT00627016|Secondary|Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.|Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.|Last 7 days of treatment|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.|||Percentage of participants|||Number
1234242|NCT00627016|Secondary|Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.|Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.|Last 7 days of treatment|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.|||Percentage of participants|||Number
1234260|NCT00626808|Primary|Geographic Region: Southern|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234243|NCT00627016|Primary|Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.|Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.|4 Weeks|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who completed at least 1 diary entry for nighttime heartburn during treatment.|||Percentage of nights||Inter-Quartile Range|Median
1234244|NCT00626925|Secondary|Gamma-glutamyl Transferase (GGT) at End of Treatment|Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers.|12 weeks (from initiation to end of treatment)|ITT|||IU/L||Standard Deviation|Mean
1234245|NCT00626925|Secondary|Gamma-glutamyl Transferase (GGT) at Midpoint|Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers.|6 weeks (from initiation to midpoint)|Subjects were measured at midpoint.|||IU/L||Standard Deviation|Mean
1234246|NCT00626925|Secondary|Severity of Alcohol-related Problems at End of Treatment|The Short Inventory of Problems (SIP). The SIP, a 15-item instrument, yields a total score that ranges from 0 to 45, higher score indicating higher levels of drinking problems. The SIP was derived from the Drinker Inventory of Consequences (DrInC), which was developed for use in Project MATCH (Miller and Tonigan 1995). We (Feinn et al. 2003) have found that, like the DrInC, the SIP measures a single factor of alcohol-related problems. Given that it is substantially shorter than the DrInC, we will use the SIP as a measure of alcohol-related consequences.|12 weeks (from intiation to end of treatment)|Subject were measured at Baseline and Endpoint.|||units on a scale||Standard Deviation|Mean
1234247|NCT00626925|Secondary|Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype||12 weeks|ITT|||Mean Abstinent Days Per Week||Standard Error|Mean
1234248|NCT00626925|Secondary|Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype||12 weeks|ITT|||Mean Heavy Drinking Days Per Week||Standard Error|Mean
1234249|NCT00626925|Secondary|Mean Daily Alcohol Consumption||12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment|Intention to Treat|||Standard Drinks per day||Standard Deviation|Mean
1234250|NCT00626925|Secondary|Mean Abstinent Days Per Week by Medication Group||12 weeks|Intention to treat (ITT).|||Mean abstinent days per week||Standard Error|Mean
1234251|NCT00626925|Primary|Mean Heavy Drinking Days Per Week by Medication Group|Change in the number of heavy drinking days during treatment phase of study. Drinking data were aggregated to the weekly level. The number of days per week of heavy drinking (i.e., four or more drinks in a day for women and five or more drinks in a day for men) and of abstinence were the primary outcomes.|12 weeks (from initiation to end of treatment)|Intention to treat (ITT)|||Number of heavy drinking days||Standard Error|Mean
1234252|NCT00626821|Primary|Quality of Life (Scale 0(Worst)-100(Best))|The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.|6-8 weeks|ITT|||units on a scale||Standard Deviation|Mean
1234253|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234254|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234255|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234256|NCT00626808|Primary|Number of Outpatient Visits: 2 or More|Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234257|NCT00626808|Primary|Number of Outpatient Visits: 1|Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234258|NCT00626808|Primary|Number of Outpatient Visits: 0|Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234261|NCT00626808|Primary|Geographic Region: North Central|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234262|NCT00626808|Primary|Geographic Region: Northeastern|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234263|NCT00626808|Primary|Vaccinating Physician Specialty: Unknown|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of physicians|||Number
1234264|NCT00626808|Primary|Vaccinating Physician Specialty: Other|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of physicians|||Number
1234265|NCT00626808|Primary|Vaccinating Physician Specialty: General/Family Practitioner|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of physicians|||Number
1234266|NCT00626808|Primary|Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist|Specialty of vaccinating physician who provided FluMist.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of physicians|||Number
1234267|NCT00626808|Primary|FluMist Use in Participants up to 59 Months of Age|Among participants up to 59 months of age who received any flu vaccine, number who received FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
1234268|NCT00626795|Secondary|Participants With Clinical Cure According to Investigator’s Assessment|At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.|At Day 4|All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.|||Participants|||Count of Participants
1234269|NCT00626795|Secondary|Participants With Clinical and Bacteriological Cure According to Investigator’s Assessment and Bacteriological Samples|"At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.~At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based."|At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up|All participants randomized to blinded treatment who received at least one application of study medication and were infected with S. aureus or S. pyogenes at baseline were included in the analysis.|||Participants|||Count of Participants
1234270|NCT00626795|Secondary|Participants With Bacteriological Cure According to Bacteriological Samples|"At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.~Bacteriological cure was either of the following:~Eradication of the baseline pathogen.~Presumed eradication of the baseline pathogen~Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.~Bacteriological failure was any of the following:~Documented lack of eradication of the baseline pathogen.~Documented relapse (re-infection) with the baseline pathogen~Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic~Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection."|At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up|Only the randomized participants that were infected with S. aureus or S. pyogenes at baseline were included in the analysis.|||Participants|||Count of Participants
1234271|NCT00626795|Secondary|Participants With Clinical Cure According to Investigator's Assessment.|At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.|At end of treatment (Day 8) and follow-up (Day 15)|All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.|||Participants|||Count of Participants
1234272|NCT00626795|Secondary|Participants With Clinical Cure According to Investigator's Assessment|At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.|At follow up (Day 15)|All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.|||Participants|||Count of Participants
1234289|NCT00626574|Secondary|To Determine if Procrit® Administration Prior to Aneurysm Clipping in Patients With Aneurysmal SAH Will Improve Neurological Assessment Scores in the Post-SAH/Post-clipping Time Period||First 10 days following clipping and 6 week f/u|Study was terminated prematurely and outcome measures were not analyzed.||||||
1234290|NCT00626574|Secondary|To Determine if Administration of Procrit® Prior to Aneurysm Clipping Reduces the Incidence of Vasospasm Following a SAH Event Treated by Vascular Clipping.||first 10 days following clipping and 6 week f/u|Study terminated prematurely. Outcome measures were not analyzed.||||||
1234291|NCT00626574|Primary|Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping|Number of adverse events|First 10 days following clipping and 6 week F/U|Pilot Study- per protocol|||adverse events|||Number
1234273|NCT00626795|Primary|Participants With Clinical Cure According to Investigator's Assessment|"At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.~Investigator's assessment of severity of infections (SIRS).~Exudates/pus~Crusting~Erythema~Oedema~Tissue Warmth~Itching~Pain~Each sign/symptoms of infection was assessed by use of the following 4-point scale:~0 = absent~2 = mild~4 = moderate~6 = severe~The scores were summed up to a total SIRS score.~Clinical cure was either of the following:~Total absence of signs and symptoms of impetigo/SITL OR~Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4.~Clinical failure was either of the following:~Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure~Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up)."|At end of treatment (Day 8)|All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.|||Participants|||Count of Participants
1234274|NCT00626782|Secondary|Post-Operative Requirement for Glaucoma Medication|Mean number of glaucoma medications used by each participant over the course of one year post-operatively.|1 day, 2 wks, 1, 3, 6 and 12 months||||number of glaucoma medications used||95% Confidence Interval|Mean
1234275|NCT00626782|Primary|Adverse Events|Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.|12 months||||percentage of participants|||Number
1234276|NCT00626743|Secondary|Maximal Change From Baseline in Standing DBP||within 8 hrs after SK3530 or placebo||||mmHg||Standard Deviation|Mean
1234277|NCT00626743|Primary|Maximal Change From Baseline in Standing SBP||within 8 hrs after SK3530 or placebo||||mmHg||Standard Deviation|Mean
1234278|NCT00626639|Secondary|Overall Survival|Deaths during long-term follow up of subject participating in the acute phase of the study receiving placebo or Palifermin.|During long-term follow-up phase, until December 2015|Subjects who received placebo duringthe acute phase of the study.|||Participants|||Count of Participants
1234279|NCT00626639|Secondary|Number of Participants With Disease Progression by Week 12|Disease progression was determined by clinical examination and histopathologic examination by the Investigator.|Up to Week 12|Tumor response data was missing for one participant.|||participants|||Number
1234280|NCT00626639|Secondary|Patient-Reported Mouth and Throat Soreness Score|"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Questionnaire for Head and Neck Cancer [OMQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).~Due to the small sample size this analysis was not performed."|Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).|||||||
1234281|NCT00626639|Secondary|Number of Participants With Severe Oral Mucositis (OM) (Adapted RTOG/EORTC Grade ≥3)|"The adapted RTOG/EORTC mucositis assessment scale as follows: Grade 0 = no change; Grade 1 = mild enanthema, mild pain; Grade 2 = patchy mucositis, moderate edema, moderate pain; Grade 3 = confluent fibrinous mucositis, massive edema, massive pain; Grade 4 = extensive ulceration, confluent necrosis, massive hemorrhage.~Due to the small sample size this analysis was not performed."|Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).|||||||
1234282|NCT00626639|Primary|Pharmacokinetics of Palifermin|Due to the small sample size this analysis was not performed.|Day -3, predose and at 2, 5, 15, 30, 60, and 90 minutes and 2, 4, 6, 8, 10, 12, 24 and 48 hours after the first dose|||||||
1234283|NCT00626639|Primary|Ratio of Ki67-positive Cells Before and After Palifermin Treatment|The effect of palifermin on cell proliferation was to be assayed by staining for the cell cycle proliferation marker Ki67 in buccal mucosal biopsy samples taken prior to the first dose and either 24 or 48 hours after the first dose. Due to the small sample size, this analysis was not performed.|Day -3 predose and 24 or 48 hours post-dose|||||||
1234284|NCT00626639|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is an undesirable medical occurrence (sign, symptom, or diagnosis) or worsening of a pre-existing medical condition occurring after start of study drug up to the end of acute oral mucositis (OM) evaluation phase, whether or not considered to be study drug related. If severe OM was not resolved by Week 12, AEs were documented until resolution of severe OM or Week 15, whichever occurred first. A serious AE is any event that is fatal, life threatening, requires or prolongs hospitalization, is a persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3 based on the following: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death related to AE. A Protocol-specific Limiting Toxicity (PSLT) is any non-hematologic Grade 3 or 4 AE considered related to study drug.|Up to Week 12 (or Week 15 for participants with severe OM was not resolved by Week 12)||||participants|||Number
1234285|NCT00626626|Secondary|Overall Survival|Observe overall survival in leukemia and lymphoma patients receiving transplant after clofarabine and cyclophosphamide conditioning.|2 years||||Participants|||Count of Participants
1234286|NCT00626626|Secondary|Disease-Free Survival|Observe disease free survivals in acute leukemia and lymphoma patients receiving allogeneic hematopoietic transplant after Clofarabine and cyclophosphamide conditioning.|Two years||||Participants|||Count of Participants
1234287|NCT00626626|Primary|Engraftment of Allogeneic Blood Cells.|"Establish the safety of Clofarabine and cyclophosphamide preceding allogeneic hematopoietic engraftment. Assess the efficacy of Clofarabine and cyclophosphamide as conditioning for promoting allogeneic hematopoietic engraftment.~Adequacy of engraftment will be assessed via assessment of chimerism (percent donor engraftment). Less than 20% engraftment by day 30 is then failure of engraftment.~Safety is defined per common toxicity criteria - Non-Hematological and non renal toxicities of ≥grade 3 or ≥grade 4 up to day 30 are scored as toxicity."|two years||||Participants|||Count of Participants
1234288|NCT00626574|Secondary|To Determine the Feasibility of Organizing a Larger, Randomized Study to Explore the Neuroprotective Effect of Procrit® in Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) When Procrit® is Administered Prior to Surgical Clipping of the Aneurysm.||When all data is collected and analyzed|Study was terminated prematurely and outcome measures were not analyzed.||||||
1234292|NCT00626561|Primary|Progression-free Survival (PFS)|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Baseline to 6 Months, or until disease progression.|Interim analysis was to be done after 10 patients enrolled, accrual not met. Study halted early.||||||
1234293|NCT00626548|Secondary|Time to Symptomatic Progression||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks|||||||
1234294|NCT00626548|Secondary|Time to Prostate-specific Antigen (PSA) Progression||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks|||||||
1234295|NCT00626548|Secondary|Health Related Quality of Life||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks|||||||
1234296|NCT00626548|Primary|Progression Free Survival|Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline|Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks|The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)|||Participants|||Number
1234297|NCT00626548|Primary|Overall Survival|Number of participants who have died at early analysis data cut off (DCO)|From date of randomization until date of death, assessed up to 33 months|The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)|||Participants|||Number
1234298|NCT00626522|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-6 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
1234299|NCT00626522|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-3 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
1234300|NCT00626522|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
1234301|NCT00626522|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
1234302|NCT00626522|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-12 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
1234303|NCT00626444|Secondary|Duration of Response||10 weeks|||||||
1234304|NCT00626444|Primary|Progression-free Survival||10 weeks|||||||
1234305|NCT00626431|Primary|Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned|The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.|||Percent suppressed||90% Confidence Interval|Number
1234306|NCT00626431|Secondary|Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population|PSA levels were measured at baseline and each treatment visit for Formulation B. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/mL||Standard Error|Mean
1234307|NCT00626431|Secondary|Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population|PSA levels were measured at baseline and each treatment visit for Formulation A. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/mL||Standard Error|Mean
1234326|NCT00626327|Secondary|Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine|The immunogenicity of one dose of MenACWY-CRM vaccine given at 7 to 9 months of age was assessed in terms of GMTs directed against N.meningitidis serogroups A, C, W-135, and Y.|1 month post vaccine dose 1|The analysis was performed on the MenACWY per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1234381|NCT00625872|Secondary|Mean Growth Velocity at Month 6|Growth velocity measures the annual rate of increase in height.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm/year||Standard Deviation|Mean
1234308|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population|The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
1234309|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population|The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
1234310|NCT00626431|Primary|Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted|The adjusted percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48||||Percent Suppressed||90% Confidence Interval|Number
1234311|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population|The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
1234312|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population|The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
1234313|NCT00626431|Secondary|Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population|Baseline was the last measurement before the first dose of Formulation B. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
1234314|NCT00626431|Secondary|Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population|Baseline was the last measurement before the first dose of Formulation A. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
1234315|NCT00626431|Primary|Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint.|The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.|||Percent Suppressed||90% Confidence Interval|Number
1234316|NCT00626405|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years||||Months||95% Confidence Interval|Median
1234382|NCT00625872|Secondary|Mean Height at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
1234317|NCT00626405|Secondary|Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval|"A confirmed tumor response is defined to be a Complete Response or Partial Response noted~> as the objective status on 2 consecutive evaluations at least 8~> weeks apart. The proportion of tumor responses will be~> estimated by the number of confirmed tumor responses divided~> by the total number of evaluable patients.~> Complete Response (CR): Disappearance of all target lesions~> Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.~> Progression (PD): At least a 20% increase in the sum of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~> Stable Disease (SD): Neither sufficient shrinkage to Qualify for PR nor sufficient increase to Qualify for PD taking as reference the smallest sum LD. responses will be calculated assuming that the number of~> confirmed tumor responses follows a binomial distribution."|Up to 5 years||||percentage of patients with response||95% Confidence Interval|Number
1234318|NCT00626405|Primary|Progression-free Survival at 6 Months|The primary endpoint is the 6 month post registration Progression-free survival (PFS) rate. Progression-free survival time is defined as the time from registration to documentation of disease progression using the RECIST criteria. Patients who died without documentation of disease progression will be considered to have progressed at death unless there is sufficient documented evidence to conclude no progression occurred prior to death. All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 6 month PFS rate.|at 6 months|The first 41 eligible patients randomized to each treatment arm.|||% of patients alive and progression free||90% Confidence Interval|Number
1234319|NCT00626392|Secondary|Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).|||Number of Events per Subject per Week||Standard Deviation|Mean
1234320|NCT00626392|Secondary|Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).|||Scores on a Scale||Standard Deviation|Mean
1234321|NCT00626392|Secondary|Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).|||Percentage of Subjects|||Number
1234322|NCT00626392|Primary|Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment|The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.|From Baseline to end of Week 1|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).|||Percentage of Subjects|||Number
1234323|NCT00626340|Primary|Comparison of Cortical GABA Levels in 4 Groups of Subjects Using Estrogen Alone, Fluoxetine Alone, Estrogen and Fluoxetine Combined in Pre and Post 4.0T Magnetic Resonance Spectroscopy Sessions.|"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.~We only know that 18 participants completed, but as far as we know data was never analyzed for these 18 participants."|Healthy controls will undergo scans pre and post 3 weeks of estrogen treatment. Women with depression will undergo scans pre and post 6 weeks of treatment with estrogen alone, estrogen and fluoxetine, or fluoxetine alone|UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.||||||
1234324|NCT00626327|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|The safety profile of MenACWY-CRM and MMRV vaccines when given concomitantly as compared to when MenACWY-CRM or MMRV was given alone is reported in terms of number of subjects reporting unsolicited adverse events (AEs), medically significant adverse events and serious adverse events (SAEs) after vaccination.|Day 1- Day 180 (Through out the study)|This analysis was done on the safety set population|||Participants|||Number
1234325|NCT00626327|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination|"Safety and tolerability of MenACWY-CRM and MMRV vaccines when given concomitantly compared to when either MenACWY-CRM or MMRV vaccine was administered alone is reported in terms of the number of subjects with local and systemic adverse events after vaccination.~Systemic reactions including axillary temperature reported during 28 days after vaccination at 12 months of age. These included the following systemic reactions: Measles-like rash, Rubella-like rash, Varicellalike rash, injection site rash, Mumps-like symptoms and axillary temperature."|upto 7 days after any vaccination|The analysis was performed on the safety set population|||Participants|||Number
1234427|NCT00625729|Secondary|Number of Patients With Overall Survival|Number of patients alive at 6 months after treatment.|6 Months||||Participants|||Number
1234327|NCT00626327|Secondary|Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine|The percentages of subjects with hSBA ≥1:4 and hSBA ≥1:8 after one dose of MenACWY-CRM vaccine (at 7-9 months), are reported|1 month post vaccine dose 1|The analysis was performed on the MenACWY per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1234328|NCT00626327|Secondary|Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.|"The percentages of subjects showing seroconversion response to varicella after concomitant administration of MMRV vaccine (at 12 months) with MenACWY-CRM vaccine compared to when MMRV vaccine is given alone, is reported .~Seroconversion for varicella is defined as percentage of subjects who show pre-vaccination antibody titer <1.25 gp ELISA units/mL to a post-vaccination antibody titer ≥1.25 gp ELISA units/mL."|6 weeks post vaccination|The analysis was performed on the MMRV per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1234329|NCT00626327|Secondary|Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.|The GMTs directed against measles, mumps, rubella and varicella, following one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.|6 weeks post vaccination|"The analysis was performed on the MMRV per-protocol population.~Only subjects with a baseline titer below the specified cut-off for that antigen were included in the immunogenicity analysis for the same antigen."|||Titers||95% Confidence Interval|Geometric Mean
1234330|NCT00626327|Secondary|Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine|The geometric mean titers (GMTs) directed against N.meningitidis serogroups A, C, W-135 and Y, following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months of age), when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1234331|NCT00626327|Secondary|Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine|The percentages of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 and 12 months of age) when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1234332|NCT00626327|Primary|Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine|The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1234333|NCT00626327|Primary|Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.|"Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.~The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA).~The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup."|6 weeks post second dose|The analysis was performed on the MenACWY per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1234334|NCT00626327|Primary|Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine|"Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.~Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella.~Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and –10% (varicella)."|6 weeks post vaccination|The analysis was performed on the MMRV per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1234335|NCT00626275|Primary|"Part B: The Mean of Daily Average Now Lower Extremity Pain Intensity (LEPI) Score During the 2-Week Period"|"Participants assessed their “Now” LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken.~LS means and SE were calculated from an analysis-of-covariance model with effect for treatment and baseline “Now” LEPI (before dosing for Treatment Period 1 of Part A) as a covariate. Participants with no postbaseline assessments were excluded from the baseline summary."|Baseline through 2 Weeks|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Error|Least Squares Mean
1234378|NCT00625872|Secondary|Mean Height-Standard Deviation Score (SDS) at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
1234336|NCT00626275|Secondary|Part A: Participant’s Global Evaluation of Study Medication|For each treatment period during Part A, each participant’s global evaluation (overall impression) of study medication was obtained 6 hours after dosing. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from “excellent” to “poor”. Participant counts per score were reported once in Part A.|6 hours post dose during Treatment Periods 1, 2, and 3 of Part A|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||participants|||Number
1234337|NCT00626275|Secondary|Part B: Percentage of Participants Using Rescue Medication|The percentage of participants who took at least 1 dose of rescue medication during 2-week treatment period of Part B is presented.|Baseline through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||Percentage of Participants|||Number
1234338|NCT00626275|Secondary|Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period|During Part B, participants returned to the clinic for 2 additional visits at approximately weekly intervals for assessments of Overall Pain Index (OPI). Participants rated their OPI on an 11-point Numeric Pain Rating Scale (NPRS) with 0 indicating No Pain and 10 indicating Worst possible pain|Baseline through Week 1, Week 1 through Week 2, and Baseline through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
1234339|NCT00626275|Secondary|Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2|Each day during Part B, participants rated their Lower Extremity Pain Intensity over the last 24 hours on an 11-point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain|Week 1 and Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
1234340|NCT00626275|Secondary|Part B: Participants’ Global Evaluation of Study Medication|For Part B, each participant’s global evaluation (overall impression) of study medication was obtained at each weekly visit. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from “excellent” to “poor”. Participant counts per score were reported at Week 1 (Day 7) and Week 2 (Day 14).|Up to Week 1 and Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||Participants|||Number
1234341|NCT00626275|Secondary|Part A: Percentage of Participants in Each Treatment Group Achieving a 25%, 50%, or 75% Reduction From Baseline in Evoked Lower Extremity Pain Intensity Scores|Percentage was measured by identifying the number of participants who achieved the desired percentage Reduction From Baseline in ELEPI Score at either 2, 4, and 6 hours post dose and was divided the by the number of total participants in the given group and then multiplied by 100 to equate to a percentage.|Up to 2, 4, and 6 hours post dosing|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||Percentage of Participants|||Number
1234342|NCT00626275|Secondary|Part A: Mean Peak Difference in ELEPI According to the NPRS Scale|Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point NPRS. Participants were asked to rate their lower extremity pain on an 11 point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Peak ELEPID was defined as the maximum of ELEPIDs recorded at 2, 4, and 6 hours post dose. Difference = predose (baseline) NPRS score - peak NPRS score up to 6 hours post dose.|Baseline, Up to 6 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
1234343|NCT00626275|Secondary|Part A: Average Difference Between Baseline and Postdose Evoked Lower Extremity Pain Over the 4 Hours After Dosing|Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Difference = predose (baseline) ELEPI score - ELEPI score 4 hours post dose.|Baseline, 4 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose|||units on a scale||Standard Deviation|Mean
1234344|NCT00626275|Secondary|Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain|Overall Pain Intensity (OPI) was assessed by the participant using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours after dosing. Difference = predose (baseline) OPI score - OPI score 6 and 12 hours post dose.|Baseline, 6 and 12 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
1234345|NCT00626275|Secondary|Part B: Mean Daily LEPI Scores for Weeks 1 and 2|Participants assessed their “Now” LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken.|Baseline through Week 1 and Week 1 through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
1234379|NCT00625872|Secondary|Mean Height-Standard Deviation Score (SDS) at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Deviation|Mean
1234346|NCT00626275|Secondary|Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain|Overall Pain Intensity (OPI), “Now” Lower Extremity Pain Intensity (LEPI), and Evoked Lower Extremity Pain Intensity (ELEPI) were assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours (hr) after dosing. At 15 minutes before dosing, during Period 1 only, participants were also asked to assess their average LEPI over the last 24 hours as a baseline measurement. “Now” LEPI was assessed at 15 minutes before dosing for baseline and at the 1-, 2-, 3-, 4-, 5-, 6-, and 12-hour time points. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then (after the “Now” LEPI assessment) he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI.|Baseline up to 12 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
1234347|NCT00626275|Primary|Part A: Average Difference Between Baseline and Post Dose Evoked (by Treadmill Walking) Lower-Extremity Pain Intensity Scores (AELEPID) Over the 6 Hours After Dosing|"Approximately 1 hour before baseline and again approximately 45 minutes before the 2-, 4-, and 6-hour time points, participants rested for 45 minutes, then they started the treadmill walk at 15 minutes before baseline and at the 2-, 4-, and 6-hour time points. After the treadmill walk, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. The average difference between baseline and 6 hours post dose evoked lower-extremity pain intensity scores (AELEPID-6) is presented for each treatment group. Difference = predose (baseline) NPRS score - NPRS score 6 hours post dose.~Least square (LS) means and standard errors (SE) were calculated from an analysis-of-covariance (ANCOVA) model with fixed effects for sequence, treatment, period, predose evoked lower extremity pain intensity as a covariate, and a random effect for participant nested within sequence."|Baseline through 6 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Error|Least Squares Mean
1234348|NCT00626210|Secondary|Improvement of Daytime Alertness and Quality of Life.||~1 month|||||||
1234349|NCT00626210|Primary|Nocturnal Sleep Length at 1 Month||1 month||||hours||Full Range|Median
1234350|NCT00626093|Secondary|Defibrillation Threshold Difference Obtained in Joules (J)||Baseline and 6 months||||Joules||Standard Deviation|Mean
1234351|NCT00626093|Primary|Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months|All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.|Baseline and 6 months||||Volts||Standard Deviation|Mean
1234352|NCT00626028|Secondary|Surgical Procedures at 3 Years|The 3 year follow-up survival assessment consisted of a telephone call to subjects to obtain information on surgeries received pertaining to pulmonary or cardiac disease|3 years after treatment||||Participants with surgical procedures|||Number
1234353|NCT00626028|Secondary|Serious Adverse Events||12 hours after discontinuation of gas or dischange (whichever comes first)|||||||
1234354|NCT00626028|Secondary|Adverse Events||treatment 1 through treatment 3|||||||
1234355|NCT00626028|Secondary|Surgical Procedures at 1 Year|The 1 year follow-up survival assessment consisted of a telephone call to subjects to obtain information on surgeries received pertaining to pulmonary or cardiac disease|1 year after treatment||||Participants with surgical procedures|||Number
1234356|NCT00626028|Primary|Reversible Pulmonary Hypertension (Vasoreactivity)as Defined by Hemodynamic Measurements|Hemodynamic measurements (heart rate, systolic arterial blood pressure,diastolic arterial blood pressure, mean arterial pressure, mean central venous pressure, systolic pulmonary arterial pressure, diastolic pulmonary arterial pressure, mean pulmonary wedge pressure and cardiac output) were used to measure reversible pulmonary hypertension (vasoreactivity).|1 year|One hundred thirty six participants were enrolled (intent-to-treat population), 124 received study drug.|||Participants|||Number
1234357|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||72 hrs|||||||
1234358|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||24 hrs|||||||
1234359|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||7 hrs|||||||
1234360|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant.||Before inhalation (0hrs)|||||||
1234361|NCT00625989|Primary|The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells|Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.|24 hrs||||number of cells/g of sputum||Standard Deviation|Mean
1234362|NCT00625989|Primary|The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells|Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.|24 hrs||||number of cells/g of sputum||Standard Deviation|Mean
1234363|NCT00625872|Secondary|Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18|Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||mm||Standard Error|Least Squares Mean
1234364|NCT00625872|Secondary|Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6|Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||Millimeter (mm)||Standard Error|Least Squares Mean
1234365|NCT00625872|Secondary|Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18|The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion). The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
1234366|NCT00625872|Secondary|Change From Baseline in Head Circumference at Months 6, 12 and 18|The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion).|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
1234367|NCT00625872|Secondary|Body Mass Index-Standard Deviation Score (BMI-SDS)|The BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg) divided by the height (m) squared. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
1234368|NCT00625872|Secondary|Sitting Height-Standard Deviation Score (SDS)|Sitting height was measured using a stadiometer with a specialized chair. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
1234369|NCT00625872|Primary|Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6|Vmax was measured by Leonardo Jumping Platform during two-leg jump.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.|||m/s||Standard Error|Least Squares Mean
1234370|NCT00625872|Primary|Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|Vmax was measured by Leonardo Jumping Platform during two-leg jump.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Meter/second (m/s)||Standard Error|Least Squares Mean
1234371|NCT00625872|Primary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Newtons||Standard Error|Least Squares Mean
1234372|NCT00625872|Secondary|Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm/year||Standard Error|Least Squares Mean
1234373|NCT00625872|Secondary|Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||cm/year||Standard Error|Least Squares Mean
1234374|NCT00625872|Secondary|Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Error|Least Squares Mean
1234375|NCT00625872|Secondary|Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Error|Least Squares Mean
1234376|NCT00625872|Secondary|Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18||Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm/year||Standard Deviation|Mean
1234377|NCT00625872|Secondary|Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm/year||Standard Deviation|Mean
1234380|NCT00625872|Secondary|Mean Growth Velocity at Months 12 and 18|Growth velocity measures the annual rate of increase in height.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm/year||Standard Deviation|Mean
1234383|NCT00625872|Secondary|Mean Height at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Deviation|Mean
1234384|NCT00625872|Secondary|Mean Calf Circumference|Calf measurements were taken as a mean of 3 consecutive measurements at largest part of calf muscle, usually about 4 inches down from below the knee.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
1234385|NCT00625872|Secondary|Mean Thigh Circumference|Thigh measurements were taken as a mean of 3 consecutive measurements at upper thigh about an inch down from the crotch line.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
1234386|NCT00625872|Secondary|Mean Upper Arm Circumference||Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||centimeter (cm)||Standard Deviation|Mean
1234387|NCT00625872|Other Pre-specified|Change From Baseline in Bone Stability Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone stability was measured by pqCT. Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- (or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||z-score||Standard Error|Least Squares Mean
1234388|NCT00625872|Other Pre-specified|Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone structure was measured by pqCT.Parameters included:total area,cortical area,marrow area,cortical thickness,cortical density of the radius,bone strength,cross-sectional muscle and fat area,total bone density,bone mineral count,trabecular BMD,bone cross-sectional area.Baseline and post-baseline SDS values transformed to age and sex specific z-score([Ln(test result/M)]/S);Ln=natural logarithm;M=age-/height- and sex-specific mean value;S=age-/height- and sex-specific coefficient of variation).Positive values are above the average for participant’s age and sex;negative values are below.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||z-score||Standard Error|Least Squares Mean
1234389|NCT00625872|Other Pre-specified|Change From Baseline in Bone Density Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone Mineral Density (BMD) was measured by pqCT. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population and more positive scores indicate higher BMD compared to age matched population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||z-score||Standard Error|Least Squares Mean
1234390|NCT00625872|Secondary|Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18|MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kg||Standard Error|Least Squares Mean
1234391|NCT00625872|Secondary|Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6|MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||kg||Standard Error|Least Squares Mean
1234392|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising).|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||seconds||Standard Deviation|Mean
1234393|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kN||Standard Deviation|Mean
1234394|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kW||Standard Deviation|Mean
1234430|NCT00625729|Secondary|Number of Patients With Overall Response|Overall response (complete remission plus partial remission) rate at 3 months, as defined by International Working Group for non-Hodgkin lymphoma and NCI Working Group guidelines for chronic lymphocytic leukemia|3 Months||||Participants|||Number
1234395|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18|Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||seconds||Standard Deviation|Mean
1234396|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6|Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||seconds||Standard Deviation|Mean
1234397|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||m/s||Standard Deviation|Mean
1234398|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||m/s||Standard Deviation|Mean
1234399|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kN||Standard Deviation|Mean
1234400|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||kilonewton (kN)||Standard Deviation|Mean
1234401|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kW||Standard Deviation|Mean
1234402|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||kilowatt (kW)||Standard Deviation|Mean
1234403|NCT00625872|Secondary|Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18|Vmax was measured by Leonardo Jumping Platform during one leg jump.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||m/s||Standard Deviation|Mean
1234467|NCT00625183|Secondary|Distant Relapse Rate||For up to 5 years following surgery.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was not collected for this assessment.||||||
1234404|NCT00625872|Secondary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during one leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Newtons||Standard Deviation|Mean
1234405|NCT00625872|Secondary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18|PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during one leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||W/kg||Standard Deviation|Mean
1234406|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18|CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years’ checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Units on a scale||Standard Deviation|Mean
1234407|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18|"NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} Yes answers(1);sum of C Yes answers(2);sum of IC Yes answers(3);sum of differences of C-IC Yes answers with high associative items{ 87%-95%}(4);sum of differences of C-IC Yes answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes."|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Units on a scale||Standard Deviation|Mean
1234408|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6|"NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} Yes answers(1);sum of C Yes answers(2);sum of IC Yes answers(3);sum of differences of C-IC Yes answers with high associative items{ 87%-95%}(4);sum of differences of C-IC Yes answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes."|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Units on a scale||Standard Deviation|Mean
1234409|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18|"The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); Sustained Attention, change of reaction (Flexibility); Divided Attention, controlled reaction disposition (Go/No go) and Vigilance. It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results."|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Seconds||Standard Deviation|Mean
1234410|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6|"The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); Sustained Attention, change of reaction (Flexibility); Divided Attention, controlled reaction disposition (Go/No go) and Vigilance. It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results."|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure and 'n' signifies participants who received the study drug and evaluated at the time point for each group respectively.|||Seconds||Standard Deviation|Mean
1234411|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18|K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Units on a scale||Standard Deviation|Mean
1234428|NCT00625729|Secondary|Number of Patients With Adequate Natural Killer Cells Infused|Incidence of donor products that met release criteria in accordance with FDA regulations (Lot Release Criteria for allogeneic, interleukin-2 (IL-2) activated natural killer (NK) cell products (BB-IND 8847) and the NK cell numbers infused (donor NK cell dose 1.5-8.0 x 10^7/kg).|Day 0||||Participants|||Number
1234429|NCT00625729|Secondary|Number of Patients Whose Disease Progressed After Treatment|Includes patients (with non-Hodgkin leukemia or chronic lymphocytic leukemia) whose disease progressed after treatment.|6 Months|Only patients who responded to treatment included in the analysis.|||Participants|||Number
1234412|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6|K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1234413|NCT00625872|Primary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Newtons||Standard Error|Least Squares Mean
1234414|NCT00625872|Primary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6|PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.|||W/kg||Standard Error|Least Squares Mean
1234415|NCT00625872|Primary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|Peak jump power (PJP) was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Watt/kilogram (W/kg)||Standard Error|Least Squares Mean
1234416|NCT00625820|Secondary|Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy.||12 weeks||||ml/min/1.73m2||Standard Deviation|Mean
1234417|NCT00625820|Secondary|Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy.||12 weeks||||mmHG||Standard Deviation|Mean
1234418|NCT00625820|Primary|The Primary Outcome Measure is Level of Albuminuria.|Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy.|12 weeks|All participants who finished the trial were analyzed|||ratio||Standard Deviation|Mean
1234419|NCT00625807|Secondary|Self Compassion|This scale assesses one’s ability to be forgiving and kind to oneself in difficult circumstances. Scores range from 1-5. Higher scores mean more self compassion.|Pre, week 8|individuals who completed the measure at week 8|||units on a scale||Standard Deviation|Mean
1234420|NCT00625807|Primary|Anxiety Severity Index|the Anxiety Sensitivity Index (ASI) is a measure of individuals discomfort with a variety of sensations associated with anxiety and panic and tends to be substantially higher in those with panic disorder (and attacks) than in those with General Anxiety Disorder. Scores range from 0 - 64. Lower scores mean lower anxiety.|Pre, 8 weeks|Individuals who completed at least one measure at post|||units on a scale||Standard Deviation|Mean
1234421|NCT00625807|Primary|Penn State Worry Questionnaire|The Penn State Worry Questionnaire (PSWQ) is a standard self-report questionnaire that is designed to assess symptoms of General Anxiety Disorder. scores range from 16-80 with higher scores meaning more stress.|Pre, 8 weeks|Individuals who completed at least one measure at post|||units on a scale||Standard Deviation|Mean
1234422|NCT00625807|Primary|Perceived Stress Scale|The PSS is brief, validated and widely used psychological instrument for assessing a subject’s perception of stress change. Scores range from 0-40 with higher scores meaning more stress|Pre, 8 weeks|Individuals who completed at least one measure at post|||units on a scale||Standard Deviation|Mean
1234423|NCT00625807|Primary|Five Facet Mindfulness Questionnaire|The Five Facet Mindfulness Questionnaire (FFMQ) has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness in community samples. Scores range from 39-195 with higher scores meaning more mindfulness.|Pre, 8 weeks|Individuals who completed at least one measure at post|||units on a scale||Standard Deviation|Mean
1234424|NCT00625807|Primary|Brain Activity (fMRI) During the Body Scan Meditation|Seed based functional connectivity analysis was performed using the Connectivity Toolbox (CONN) implemented within the Statistical Parametric Mapping program (SPM8; Welcome Department of Cognitive Neurology). Our seeds were located in the right inferior frontal gyrus pars opercularis (MNI coordinates: 54, 14, 16) and the dorsal anterior insula (MNI coordinates: 32, 20, 0). Note - MRI data from some subjects was either missing, not collected, or corrupted, and so the analyses were performed on just the subject of subjects who had complete datasets. This assessment reflects the total number of voxels per group.|Week 8||||voxels|||Number
1234425|NCT00625742|Secondary|Improvement of Clinical Outcomes|Improvement of clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).|Baseline to Day 29, approximately 30 days|Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.||||||
1234426|NCT00625742|Primary|Participant Gain in Lean Body Mass|Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).|Baseline to Day 29, approximately 30 days|Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.||||||
1234431|NCT00625729|Secondary|Number of Patients With Interleukin-15 Production and NK Cell Expansion|Correlation of interleukin-15 production at day 0 with natural killer (NK) cells expansion|Day 0|Correlation of interleukin-15 with Natural Killer Cell expansion cannot be calculated because there was no Natural Killer Cell expansion.|||Participants|||Number
1234432|NCT00625729|Primary|Number of Patients Exhibiting Natural Killer Cell Expansion|Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population.|Day 14||||Participants|||Number
1234433|NCT00625586|Primary|Proportion of Patients Alive at 8 Months||8 months|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.||||||
1234434|NCT00625586|Secondary|Cmax|RAV12 and gemcitabine cmax|29 days|||||||
1234435|NCT00625586|Secondary|Adverse Events|Frequency of adverse events and serious adverse events|any timeframe following study drug up to 3 years|||||||
1234436|NCT00625586|Secondary|Overall Survival||three years|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.||||||
1234437|NCT00625586|Secondary|Progression-free Survival||time to progression or death, up to 3 years|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.||||||
1234438|NCT00625586|Secondary|Partial Response and Complete Response Rates|Based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0; partial response = 30% decrease in sum of longest diameter. complete response = 100% decrease in sum of longest diameter. Rate of response = proportion of complete or partial responses based on number of patients evaluated.|8 months|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.||||||
1234439|NCT00625586|Secondary|Proportion of Patients Alive at 12 Months||12 months|||||||
1234440|NCT00625443|Secondary|Number of Participants With Changes in Concomitant Steroid Use|A participant who used steroids at study entry was considered to have permanently discontinued steroid use if they had no steroid use during the last 8 weeks of the study Treatment Period. A participant who used steroids at study entry was considered to have decreased concomitant steroid medication by at least 50% if they permanently discontinued steroids, or in no dose of steroid was higher than 50% of their baseline steroid dose during the last 8 weeks of the study Treatment Period.|Day 1 through last 8 weeks of the Treatment Period|FAS. Data was summarized using the OC method. Only those participants who had data available at both Baseline and post-Baseline were analyzed.|||Number of participants|||Number
1234441|NCT00625443|Secondary|Percentage of Participants Who Achieved a Durable, Transient, or Overall Platelet Response|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) “Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
1234442|NCT00625443|Secondary|Percentage of Participants Who Maintained Response-Level Platelet Count|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) “Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
1234443|NCT00625443|Secondary|Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) “Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
1234468|NCT00625183|Secondary|Local Relapse Rate||For up to 5 years following surgery.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.||||||
1234469|NCT00625183|Secondary|Dose Intensity||During treatment with capecitabine, oxaliplatin, selenomethionine.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.||||||
1234444|NCT00625443|Secondary|Percentage of Participants Who Maintained a Platelet Count of 100,000/mm^3 or Higher by Response Status|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) “Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
1234445|NCT00625443|Secondary|Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) “Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
1234446|NCT00625443|Secondary|Median Platelet Counts at Selected Analysis Timepoints|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) “Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Day 1, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|Full analysis set (FAS) included all participants who completed 501-CL-003 and received study drug in the current study, except baseline values and ITP-directed medications taken during the 2-week period before the first dose of avatrombopag in the current study. Data was summarized using the observed case (OC) method.|||Platelets x 1000/mm^3||Full Range|Median
1234447|NCT00625443|Primary|Incidence of Drug-Related TEAEs|Drug-related TEAEs included those whose relationship was categorized as possible or probably by the investigator. A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).|Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.|"Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term post-treatment refers to any assessment timepoint after the participant received at least one dose of study drug."|||Participants|||Count of Participants
1234448|NCT00625443|Primary|Incidence of Severe (Grade 3 or 4) TEAEs|A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).|Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.|"Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term post-treatment refers to any assessment timepoint after the participant received at least one dose of study drug."|||Participants|||Count of Participants
1234470|NCT00625183|Secondary|Safety and Tolerability as Assessed by NCI CTCAE Version 3.0|Number of participants with any adverse event as assessed by NCI CTCAE version 3.0.|Adverse events were queried for and collected every cycle for the duration of treatment.|All treated and eligible patients|||Participants|||Count of Participants
1234471|NCT00625183|Primary|Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy||After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.||||||
1234449|NCT00625443|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of study drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. Related AEs included those whose relationship was categorized as possible or probably by the investigator. Dose interruption includes dose decreased, dose previously stopped, permanently stopped, or temporarily stopped. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).|Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.|"Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term post-treatment refers to any assessment timepoint after the participant received at least one dose of study drug."|||Participants|||Count of Participants
1234450|NCT00625404|Secondary|Participant Report of Change in Number of Sexual Partners|Difference in mean number of reported sexual partners between final study visit and enrollment visit|Up to 52 weeks|Women reporting on sexual behavior during follow-up|||mean number of sexual partners||Standard Deviation|Mean
1234451|NCT00625404|Secondary|Pill Counts and Participant Report of Adherence to Once-daily Pill Taking|Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts|Up to 52 weeks|All randomized participants who completed at least one follow-up visit, excluding women found to have been infected at enrollment|||percentage of days||Standard Deviation|Mean
1234452|NCT00625404|Secondary|Pregnancy Complications|Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications|up to 60 weeks|Women becoming pregnant during regular follow-up in the study (70 in Truvada group and 45 in placebo group)|||participants|||Number
1234453|NCT00625404|Secondary|FTC and/or Tenofovir Resistance|"Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).~participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time."|up to 52 weeks|All women who seroconverted were assessed for possible resistance.|||participants|||Number
1234454|NCT00625404|Secondary|CD4+ T-cell Count|CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks|Up to 16 weeks||||cells/mL||Standard Deviation|Mean
1234455|NCT00625404|Secondary|Plasma HIV RNA Level (HIV-1 Viral Load)|Viral load at the time of HIV detection, HIV conversion and through 16 weeks|up to 16 weeks|68 women who became infected post-enrollment were included in viral load analyses. Only 48 of these women (27 on Truvada and 21 on placebo) contributed a specimen sample for analysis at the 16-weeks post seroconversion visit|||log copies/mL||Standard Deviation|Log Mean
1234456|NCT00625404|Primary|Confirmed Grade 3 or Higher AST Elevation|Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal|Through 52 weeks on product and 4 weeks post-product||||participants|||Number
1234457|NCT00625404|Primary|Confirmed Grade 3 or Higher ALT Elevation|Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal|Through 52 weeks on product and 4 weeks post-product||||participants|||Number
1234458|NCT00625404|Primary|Confirmed Grade 3 or Higher Reduction in Phosphorus|Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL|Through 52 weeks on product and 4 weeks post-product||||participants|||Number
1234459|NCT00625404|Primary|Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration|The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.|10-26 months per site|The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.|||Number of adverse events|||Number
1234460|NCT00625404|Primary|Confirmed Grade 2 or Higher Serum Creatinine Toxicity|Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal|cumulative toxicity through 52 weeks of product use and 4 weeks post product|The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.|||participants|||Number
1234461|NCT00625404|Primary|HIV Infection|HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.|Cumulative HIV infection between enrollment and 52 weeks|All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population|||participants|||Number
1234462|NCT00625391|Secondary|Oxidative Stress Damage Biomarker|Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test|24 weeks|Analyzed who completed the study.|||ng/mg creatinine||Standard Deviation|Mean
1234463|NCT00625391|Primary|Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker|Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)|24 weeks|Analyzed on those who completed the study. Percent change relative to the baseline for each group.|||percentage change from baseline||Standard Deviation|Mean
1234464|NCT00625365|Secondary|Adverse Events|Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration|Through 24 hours||||Participants|||Number
1234465|NCT00625365|Secondary|Serious Adverse Events|Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration|Through 24 hours||||Participants|||Number
1234466|NCT00625365|Primary|The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration||during or within 30 minutes of administration|The safety population was analyzed per the protocol|||Participants|||Number
1234472|NCT00625183|Primary|Complete Pathological Response Rate||After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was not collected for this assessment.||||||
1234473|NCT00625131|Secondary|Smoking Craving|"Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment. This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period. The craving score is based on a single diary item Please rate your desire to smoke right now with a Likert scale score ranging from 1 (none) to 5 (severe). Higher craving is worse, as lower craving is presumed to reflect decreased risk of smoking lapse or relapse."|Daily between visits 2-12||||units on a scale||Standard Deviation|Mean
1234474|NCT00625131|Secondary|Carbon Monoxide Monitoring|Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)|Session 12 (6 weeks post-treatment)|Please note that this secondary outcome (bioverification by CO reading) is not a measure of complete smoking abstinence during the study period (or during the week prior to the session - see Primary Outcome). It is independent of self-reported smoking abstinence. It is not unexpected that CO readings different than self-reported smoking.|||participants|||Number
1234475|NCT00625131|Primary|Smoking Abstinence, Self-reported|Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment|Week prior to Session 12 at 6 weeks post-treatment|Any participants who did not attend Session 12 for any reason (i.e., lost to contact, withdrawn after beginning treatment) were counted as smoking (i.e., intent-to-treat analyses, missing = smoking).|||participants|||Number
1234476|NCT00624923|Secondary|Determination of Whether Baseline Vitamin D Levels Predict Clinical Response to Salsalate, and Whether Hypovitaminosis D is Associated With Plaque Progression.||baseline to 30 mo|||||||
1234477|NCT00624923|Secondary|Relationship Between Vitamin D Status and Coronary Calcification, as Well as With Insulin Resistance (HOMA-IR), Beta-cell Function (HOMA-%Beta), and Serum Levels of Inflammatory Cytokines and Adhesion Molecules, Known to be Related to CVD Risk.||Baseline evaluation|||||||
1234478|NCT00624923|Secondary|Comparison of Numbers of Persons Who Regress From ATPIII Metabolic Syndrome Criteria (for Those With Metabolic Syndrome at Baseline)||baseline to 30 mo|||||||
1234479|NCT00624923|Secondary|Comparison of Numbers of Persons With Metabolic Syndrome Who Progress to Diabetes Between Groups.||baseline to 30 mo|||||||
1234480|NCT00624923|Secondary|Comparison of Rates of Addition of Anti-hypertensive, Diabetic, or Lipid Lowering Medication.||baseline to 30 mo|||||||
1234481|NCT00624923|Secondary|Reduction of Inflammation in the Liver Associated With Nonalcoholic Steatohepatitis (NASH), and Reduction of Fatty Liver Quantitated by Computerized Tomography and Levels of AST and ALT as Markers of Liver Inflammation Related to NASH.||baseline to 30 mo|||||||
1234482|NCT00624923|Secondary|Reduction of Insulin Resistance Assessed by Fasting Insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR).||baseline to 30 mo|||||||
1234483|NCT00624923|Secondary|Reduction of Mediators of Inflammation in the Circulation (Such as CRP), and Markers of Oxidative Stress.||baseline to 30 mo|||||||
1234484|NCT00624923|Secondary|Change in the Metabolic Syndrome Assessed by Measures by Waist/Hip Ratio, Systolic and Diastolic Blood Pressure, Lipid Profiles (Total Cholesterol, Triglycerides, HDL and LDL), and Abdominal Adiposity Quantitated by Computerized Tomography||Baseline to 30 mo|||||||
1234485|NCT00624923|Primary|Change in Non-calcified Plaque Volume in the Coronary Arteries Assessed by MDCTA From Baseline to 30 Months||Baseline to 30 months|Intention to Treat|||mm^3||95% Confidence Interval|Mean
1234486|NCT00624832|Secondary|Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients|"Late-phase allergic response (LAR) was only determined for those patients who had an LAR >= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the best post saline (Control) FEV1 was used. LAR (%) = 100*[FEV1 (0) - Minimum FEV1 (3-8h)]/FEV1 (0)."|Week 0, Week 8 and Week 16|Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.|||Percentage of LAR||Standard Deviation|Mean
1234487|NCT00624832|Primary|Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients|"The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge:~EAR = 100* [ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)] / FEV1 (0). For FEV1 (0), the ”best post saline (Control) FEV1” was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate."|Week 8, Week 16|Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.|||Percentage of EAR||Standard Error|Least Squares Mean
1234488|NCT00624806|Primary|Percent of Participant Triggering DMP Items|Percent of participants who triggered Disease-Management Protocol items by group.|Enrollment to study end, 8 weeks||||% of participants triggering an item|Participants||Number
1234489|NCT00624806|Primary|Number of Days With Triggers at Certain Timeframe|Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.|Enrollment to study end, 8 weeks||||days|Participants||Number
1234490|NCT00624806|Primary|Days of Data|Data includes the number of triggered items and types of triggers.|Enrollment to study end, 8 weeks||||days||Full Range|Mean
1234599|NCT00624052|Secondary|Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052|The difference between the last available troughs represents the additional reduction in DBP in this study|Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
1234491|NCT00624780|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)|Safety analysis set: all randomized participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure during each specified period, for each group respectively.|||participants|||Number
1234492|NCT00624780|Other Pre-specified|Sheehan-Suicidality Tracking Scale (S-STS) Score|Sheehan-Suicidality Tracking Scale (S-STS): an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2-6, 7a, and 8 were scored on a 5-point Likert scale (ranging from 0= not at all to 4=extremely). Items 1, 1b, and 7 required yes or no responses. Total score ranged from 0 to 35, higher score indicated higher suicidal tendency.|Baseline up to Week 24|Data was not statistically summarized but was available in individual participant listings and mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) due to change in planned analysis.||||||
1234493|NCT00624780|Secondary|Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234494|NCT00624780|Secondary|Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234495|NCT00624780|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234496|NCT00624780|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234497|NCT00624780|Secondary|Clinical Global Impression - Severity (CGI-S) Score for Period 2|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234498|NCT00624780|Secondary|Clinical Global Impression - Severity (CGI-S) Score for Period 1|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234499|NCT00624780|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234500|NCT00624780|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234501|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Period 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234502|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Period 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Last observation carried forward (LOCF) method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1234503|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234504|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234505|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234506|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N(Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234507|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234508|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234509|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234510|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234511|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234512|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’=participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234513|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234514|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234515|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis.|||participants|||Number
1234516|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 1: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.|||participants|||Number
1234517|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis.|||participants|||Number
1234518|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1234519|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1234520|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1234951|NCT00621530|Secondary|Present Pain Intensity|Pain was assessed preoperatively, 2 days, and 2 and 6 months after surgery using a 0-10 (10 being worse) verbal Present Pain Intensity (PPI) scale|6 months|Some subjects were missed to follow up at different times|||units on a scale||Standard Deviation|Mean
1234521|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234522|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234523|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234524|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234525|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234526|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1234527|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234528|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis.|||units on a scale||Standard Deviation|Mean
1234600|NCT00624052|Secondary|Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6|Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
1234529|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234530|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.|||units on a scale||Standard Deviation|Mean
1234531|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1234532|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included. n=participants evaluable at given time points for each group.|||units on a scale||Standard Deviation|Mean
1234533|NCT00624585|Secondary|Number of Participants With Stable Disease (SD)||1 Year 4 Months|All Participants|||participants|||Number
1234534|NCT00624585|Secondary|Number of Participants With Partial Remission (PR)|Partial remission (PR) (modified IWG); IWG = International MDS Working Group. All of the CR criteria (if abnormal prior to treatment), except: Bone marrow evaluation: Blasts decreased by ≥ 50% over pretreatment but still >5%. Cellularity and morphology are not relevant.|1 Year 4 Months|All Participants|||participants|||Number
1234535|NCT00624585|Secondary|Number of Participants With Hematologic Improvement|Hematologic improvement in platelets, red blood cell (RBC), neutrophils according to modified IWG Criteria; Cytogenetic response (modified IWG); Change in percentage of blasts in bone marrow and peripheral blood; Src-Tyr416 phosphorylation in medullary myeloblasts. Hematologic improvements must last ≥ 8 weeks.|1 Year 4 Months|All Participants|||participants|||Number
1234536|NCT00624585|Primary|Number of Participants With Marrow Complete Remission (CR)|"Complete remission (modified IWG); IWG = International MDS Working Group.~Bone Marrow Response must last ≥4 weeks. Bone marrow evaluation: Bone marrow showing ≤5% myeloblasts with normal maturation of all cell lines."|1 Year 4 Months|All Participants|||participants|||Number
1234537|NCT00624559|Secondary|Urinary Sodium Excretion|Urine collected over 24 hour period on last day of each different sodium diet|24 hour||||mmol Na+/24 hr||Standard Error|Mean
1234538|NCT00624559|Primary|Mean Arterial Pressure|Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor|24 hours||||mm Hg||Standard Error|Mean
1234539|NCT00624520|Primary|"Mental Stress Induced Elevation in Double Product by Anger-recall Task"|"Maximum Mental Stress induced elevation in Double Product , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect"|Immediate to 6 months post intervention|Response to Mental Stress by Anger-Recall Stress Task|||mmHg x beats/minute||Standard Error|Mean
1234540|NCT00624520|Primary|Mental Stress Induced Elevation in Double Product by Math Stress Task|"Maximum Mental Stress induced elevation in Double Product , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect."|3 months post intervention|Response to mental stress by math task testing at 3 months post intervention, compared with pre-intervention. Within-group comparison is shown for matched pair data. The lower number of participants analyzed than at study entry is due to patient drop-outs during follow-up post-intervention.|||mmHg x beats/minute||Standard Error|Mean
1234541|NCT00624520|Secondary|Cardioverter-DefibrillatorTherapies|Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia|6 months post intervention|Cardioverter-defibrillator interrogation data between 3 and 6 months post intervention|||percentage of participants|||Number
1234542|NCT00624520|Secondary|Low Frequency/High Frequency Ratio of Heart Rate Variability|Heart Rate Variability measure of cardiac autonomic activity Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Decreased Low/High Frequency ratio reflects Increased High Frequency heart rate variability which correlates with increased cardiac parasympathetic activity, which may be beneficial in this patient population. Normalized units are used, reflecting percentage of total frequency power.|6 months post intervention|"Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for heart rate variability analyses during follow-up, with inclusion only of participants having accurate and appropriate data.~Data are shown for Ratios of Low and High Frequency power shown above."|||Ratio||Standard Deviation|Mean
1234543|NCT00624520|Secondary|High Frequency Heart Rate Variability|Heart Rate Variability measure of Cardiac Parasympathetic activity. Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Increased High Frequency heart rate variability correlates with increased cardiac parasympathetic activity. Normalized units are used, reflecting percentage of total frequency power.|6 months post intervention|Reduced participant numbers reflect drop-outs and exclusion of participants with non-diagnostic recordings for HRV analyses, with inclusion only of participants having accurate and appropriate data.|||percentage of spectral power||Standard Deviation|Mean
1234544|NCT00624520|Secondary|Low Frequency Heart Rate Variability|"Heart Rate Variability measure of cardiac autonomic activity, believed to reflect a combination of cardiac sympathetic and parasympathetic activity.~Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Low frequency heart rate variability correlates with cardiac sympathetic and parasympathetic activity. Increased sympathetic activity and/or decreased parasympathetic activity occur in this study population at high risk for cardiac arrhythmia. Normalized units are used, reflecting percentage of total frequency power."|6 months post intervention|6 months post intervention, from ECG recordings during mental stress tasks Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for HRV analyses during follow-up, with inclusion only of participants having accurate and appropriate data.|||percentage of spectral power||Standard Deviation|Mean
1234545|NCT00624520|Secondary|Depression/Dejection|Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..|3 months post intervention|3 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up,with inclusion only of participants having accurate and appropriate data.|||units on a scale||Standard Deviation|Mean
1234546|NCT00624520|Secondary|Perceived Stress|Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.|||units on a scale||Standard Deviation|Mean
1234547|NCT00624520|Secondary|Tension/Anxiety|Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.|||units on a scale||Standard Deviation|Mean
1234548|NCT00624520|Secondary|State Anger|Psychosocial score of negative mood derived from self-report questionnaires. Scale range was 15-45. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Serial psychometric scores up to 6 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.|||units on a scale||Standard Deviation|Mean
1234549|NCT00624520|Primary|"Mental Stress Induced Elevation in Double Product by Math Stress Task"|"Maximum Mental Stress induced elevation in Double Product , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect."|Immediate to 6 months post intervention|Response to Mental Stress by Math Stress Task.|||mmHg x beats/min||Standard Error|Mean
1234550|NCT00624468|Secondary|Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack|Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature [axillary, orally or intraauricularly] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported.|From baseline (Study Day 1) up to Week 36|ITT population included all randomized participants.|||percentage of participants|||Number
1236813|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1234551|NCT00624468|Secondary|Contrast Sensitivity: Score Line|Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||units on a scale||Standard Deviation|Mean
1234552|NCT00624468|Secondary|Contrast Sensitivity: Total Number of Letters Correctly Identified|Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||letters||Standard Deviation|Mean
1234553|NCT00624468|Secondary|Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified|Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||letters||Standard Deviation|Mean
1234554|NCT00624468|Secondary|Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36|The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."|||cubic micrometer||Standard Deviation|Mean
1234555|NCT00624468|Secondary|Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36|The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Deviation|Mean
1234556|NCT00624468|Secondary|Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36|The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Deviation|Mean
1234557|NCT00624468|Secondary|Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.|Baseline, Weeks 12 and 24|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Deviation|Mean
1234558|NCT00624468|Secondary|Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Error|Mean
1234559|NCT00624468|Primary|Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.|Baseline, LOV (Week 48)|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Deviation|Mean
1234560|NCT00624442|Secondary|Pharmacokinetics of CK-1827452 Injection in Stable Heart Failure Patients||2 days|||||||
1234561|NCT00624442|Primary|Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations|Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.|4 days|Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.|||Percentage of change||Standard Error|Least Squares Mean
1234601|NCT00624052|Secondary|Trough Seated Systolic Blood Pressure (SBP) Control|The number of patients who reached the target SBP of >=140mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||patients|||Number
1234562|NCT00624442|Primary|Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations|Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.|4 days|Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.|||msec||Standard Error|Least Squares Mean
1234563|NCT00624416|Secondary|The Number of Subjects Elected to Have the Lipoma Removed.||After four weeks up to one year.||||participants|Participants||Number
1234564|NCT00624416|Secondary|The Number of Lipoma Increased in Volume.||After four weeks of treatment up to one year.||||Lipomas|Participants||Number
1234565|NCT00624416|Primary|The Average Percent Volume Reduction in the Lipoma.||Baseline and 4 weeks||||Percent Volume reduction (cc^3)|Participants|Full Range|Mean
1234566|NCT00624377|Secondary|Percentage of Participants Which Had a Reduction of Concomitant Drug Use|The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.|8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Percentage of Participants|||Number
1234567|NCT00624377|Secondary|Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
1234568|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
1234569|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
1234570|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
1234571|NCT00624377|Primary|Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment|FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75–80%. In obstructive diseases, the value often decreased (<80%, often ~45%).|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Ratio||Standard Deviation|Mean
1234572|NCT00624377|Primary|Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment|FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 < 80% of the predicted value in combination with an FEV1/FVC < 70% confirms the presence of airflow limitation that is not fully reversible|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||liter per second||Standard Deviation|Mean
1234602|NCT00624052|Primary|Trough Seated Diastolic Blood Pressure (DBP) Control|The number of patients who reached the target DBP of <90mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||patients|||Number
1236814|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1234573|NCT00624377|Primary|Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
1234574|NCT00624338|Secondary|Mean Cumulative Corticosteroid Dose||Randomization up to Week 52|MITT population included all the randomized participants who received study treatment.|||mg||Standard Deviation|Mean
1234575|NCT00624338|Secondary|Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares|"Ordinal response categories have been defined as: 1) No BILAG A, no BILAG B, and completed treatment, 2) No BILAG A, at least 1 BILAG B during treatment period, and 3) At least 1 BILAG A during treatment period. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|Week 52|MITT population included all the randomized participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1234576|NCT00624338|Secondary|Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks|A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in “A”, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.|From screening up to Week 24|MITT population included all the randomized participants who received study treatment.|||percentage of participants|||Number
1234577|NCT00624338|Secondary|Time to First New Flare as Defined by BILAG Score A or B|"A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. Analysis was right-censored at Week 52. The hazard ratios and 95% confidence intervals were obtained from the Cox proportional hazards model. The 25th Percentile of time to new flare was reported using Kaplan-Meier estimates (Median was not reached). The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|From screening up to Week 52|MITT population included all the randomized participants who received study treatment|||days||95% Confidence Interval|Number
1234578|NCT00624338|Primary|Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B|A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in “A”, mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.|From screening up to Week 52|Modified intent-to-treat (MITT) population included all the randomized participants who received study treatment.|||percentage of participants|||Number
1234579|NCT00624286|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Intent-to-treat population: All randomized patients who received at least 1 dose of study drug. FEV1 data taken within 6 h of rescue medication was excluded from this analysis.|||Liters||Standard Error|Least Squares Mean
1234580|NCT00624286|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Intent-to-treat population: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1234581|NCT00624234|Secondary|Neuroimaging Data|Neuroimaging data consists of functional MRI and structural MRI measures.|Collected before and after intervention||2019-10-31|10/2019||||
1234582|NCT00624234|Primary|Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery – 3rd Edition; WJ-III NU) Standard Score at 15 Hours|This metric measures change in reading abilities, including word recognition and decoding, as assessed by standard educational assessments (Woodcock Johnson Psychoeducational Battery – 3rd Edition Normative Update; WJ-III NU). The scores are reported as change in age-normed standard scores (a change of 15 standard score points would represent a change of 1 standard deviation in the general population).The Basic Reading score is a normed composite of the WJ-III subtests Letter-Word Identification and Word Attack, representing word-level reading skill.|0 and 15 hours||||units on a scale||Standard Deviation|Mean
1234583|NCT00624221|Secondary|Graft Dislocation||1 day to 1 month after grafting|||||||
1234584|NCT00624221|Secondary|Best Corrected Vision||6 months and 1 year after grafting|||||||
1234585|NCT00624221|Primary|Endothelial Cell Loss|Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.|6 months after grafting||||percentage of endothelial cell loss||Standard Deviation|Mean
1234586|NCT00624195|Primary|Neuropsychological Performance Change|The outcome measure is change in performance from baseline to 16 weeks as measured by the global deficit score (GDS). The GDS is calculated by averaging the individual deficit scores from each neurocognitive test. Deficit scores for each test were calculated from age-, education-, gender-, and ethnicity-adjusted raw scores by methods that capture unexpectedly poor performance while ignoring better than expected performance. The GDS ranges in value from 0-5; higher scores indicate poorer cognitive functioning. Subjects with scores greater than or equal to 0.5 are considered cognitively impaired.|Baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
1234587|NCT00624065|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6|Mean change was calculated as Week 6 values minus Baseline values.|Baseline and Week 6|ITTE|||mmHg||Standard Deviation|Mean
1234588|NCT00624065|Primary|Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment|Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.|Week 6|Intent to Treat Efficacy (ITTE) Population: all randomized participants with efficacy (vital signs) data after a minimum of 4 weeks of treatment|||Participants|||Number
1234589|NCT00624052|Secondary|Trough DBP Control Pre- and Post- Uptitration|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.|up to 34 weeks|91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.|||patients|||Number
1234590|NCT00624052|Secondary|Additional Reduction in SBP by Use of Additional Antihypertensive Therapy|Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052|up to 34 weeks|Total for the full analysis set|||mmHg||Standard Deviation|Mean
1234591|NCT00624052|Secondary|Additional Reduction in DBP by Use of Additional Antihypertensive Therapy|Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052|up to 34 weeks|Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment|||mmHg||Standard Deviation|Mean
1234592|NCT00624052|Secondary|Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control|The number of patients with DBP control (DBP>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment|up to 34 weeks|Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment|||patients|||Number
1234593|NCT00624052|Secondary|Time to First Additional Antihypertensive|Time from first intake of medication to first intake of an antihypertensive other than the study drug|up to 34 weeks|The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment|||Days||Standard Deviation|Mean
1234594|NCT00624052|Secondary|Trough BP Normality Classes|The number of patients who reach predefined BP categories|End of study (34 weeks or last value on treatment)||||patients|||Number
1234595|NCT00624052|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose|||patients|||Number
1234596|NCT00624052|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose|||patients|||Number
1234597|NCT00624052|Secondary|Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052|The difference between the last available troughs represents the additional reduction in SBP in this study|Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
1234598|NCT00624052|Secondary|Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6|Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
1234603|NCT00624013|Secondary|Quality of Life|Quality of life (QOL) was assed at baseline and at month 6 using validated instrument Diabetes-39 Quality of Life Questionnaire. It consists of 39-item questionnaire designed to help us learn more about what affects the quality of life of people with diabetes in five dimensions of patients' lives: Diabetes Control, Anxiety and Worry, Social Burden, Sexual Functioning and Energy and Mobility. The Diabetes-39 questionnaire uses a Not Affected At All –Extremely Affected point scale score ranging from 1-7. Raw scale scores were transformed to a 0-100 scale using a linear transformation. Higher values represent a worse outcome. Overall rating of Quality-of-Life was assessed using a Lowest quality-Highest quality scale ranging from 1-7. Higher values represent an increase or improvement in overall QOL. Pattern of Diabetes Severity was measured with a Not Severe at all-Extremely Severe scale ranging from 1-7. Higher values represent increase in diabetes severity.|Month 0 and month 6||||units on a scale||Standard Deviation|Mean
1234604|NCT00624013|Primary|HbA1C (%)|Change in HbA1C (%) at month 0 and month 6|Month 0 and month 6||||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
1234605|NCT00623974|Primary|Number of Patients With Success|"A patient success is defined as a normal calcium level (Ca>=8 and Ca<= 10.5) within 48 hours post-treatment initiation and a normal Ca level maintained through day 7 post-treatment initiation."|2 - 7 days post-treatment|Terminated due low accrual, none of 7 participants met eligibility criteria therefore not treated nor randomized to study arms.||||||
1234606|NCT00623935|Secondary|Percentage of Participants Alive at 1 Year|One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor.|1 year|56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).|||percentage of participants||95% Confidence Interval|Number
1234607|NCT00623935|Primary|Percentage of Participants With Relapse Free Survival at 1 Year|The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.|1 year|56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).|||percentage of participants||95% Confidence Interval|Number
1234608|NCT00623831|Secondary|Number of Participants With Best Overall Tumor Response|Tumor responses evaluated using computed tomography and categorized according to RECIST version 1.0 at pre-treatment and 4 weeks after the last dose of study treatment. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 3 months|The Tumor Response Analysis Set comprises all subjects who had an end-of-study tumor assessment performed.|||participants|||Number
1234609|NCT00623831|Secondary|Number of Participants With Serum NY-ESO-1-specific Immune Responses|Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. [Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor]|Up to 3 months|The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.|||participants|||Number
1234610|NCT00623831|Primary|Number of Participants With Pyrogenicity at Each Dose Level Tested in the Intrasubject Dose Escalation Performed Over a Dose Range of 250 to 547,000 EU|Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.|Weeks 1 through 6|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||participants|||Number
1234611|NCT00623831|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.|Up to 3 months|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||participants|||Number
1234612|NCT00623805|Secondary|Percentage of Participants With a R0 Resection|An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.|Baseline to the end of the study (up to 4 years, 2 months)|||||||
1234613|NCT00623805|Secondary|Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery||Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.|||Percentage of participants|||Number
1234614|NCT00623805|Secondary|Duration of Response|Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|||||||
1234615|NCT00623805|Secondary|Time Until a Complete Response or a Partial Response|Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.|Baseline to Month 13|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. Only participants with a complete response or a partial response were included in the analysis.|||Months||Standard Deviation|Mean
1234616|NCT00623805|Secondary|Percentage of Participants With a Complete Response or a Partial Response|A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.|||Percentage of participants|||Number
1234617|NCT00623805|Secondary|Overall Survival|Overall survival was defined as the time from the first administration of study drug to death.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.|||Months||Standard Error|Mean
1234618|NCT00623805|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.|||Months||Standard Error|Mean
1234619|NCT00623779|Secondary|Ecarin Clotting Time (ECT)|Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)||||sec||Full Range|Median
1234620|NCT00623779|Secondary|Activated Partial Thromboplastin Time (APTT)|Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)||||sec||Full Range|Median
1234621|NCT00623779|Secondary|Change in D-Dimer Level|Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)||||ng/ml||Full Range|Median
1234622|NCT00623779|Secondary|Plasma Concentration of AR-H067637XX (Active Metabolite)|Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit|4 weeks after baseline according to protocol||||nmol/L||Full Range|Median
1234623|NCT00623779|Secondary|Plasma Concentration of AZD0837 (Prodrug)|Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit|4 weeks after baseline according to protocol||||nmol/L||Full Range|Median
1234624|NCT00623779|Secondary|Bilirubin|Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3|||Participants|||Number
1234625|NCT00623779|Secondary|Alanine Aminotransferase (ALAT)|Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3|||Participants|||Number
1234626|NCT00623779|Secondary|Change in Creatinine Level|Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol (randomisation visit to week 4 visit)||||umol/L||Standard Deviation|Mean
1234627|NCT00623779|Secondary|Bleeding Events|Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3|||Participants|||Number
1234628|NCT00623779|Primary|Compliance With Study Visits/Assessments|(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100|28 weeks (randomisation visit to last follow up visit) according to protocol||||Percentage||Standard Deviation|Mean
1234629|NCT00623779|Primary|Compliance With Study Drug|[(number of doses dispensed-number of doses returned)/number of days between visits]*100|24 weeks (randomisation visit to last treatment visit) according to protocol||||Percentage||Standard Deviation|Mean
1234630|NCT00623779|Primary|Premature Discontinuation of Study Due to Any Reason|"|The premature discontinuation of study due to any reason"|28 weeks (randomisation visit to last follow up visit)||||Participants|||Number
1234631|NCT00623779|Primary|Premature Discontinuation of Study Drug Due to Any Reason|The premature discontinuation of study drug due to any reason|24 weeks (randomisation visit to last treatment visit)||||Participants|||Number
1234632|NCT00623779|Primary|Premature Discontinuation of Study or Study Drug Due to Any Reason|The premature discontinuation of study or study drug due to any reason|28 week (randomisation visit to last follow up visit in study) according to protocols||||Participants|||Number
1234633|NCT00623766|Secondary|Overall Survival (OS)|OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive.|From first dose to 24 months|All participants who received at least 1 dose of ipilimumab|||Months||95% Confidence Interval|Median
1234634|NCT00623766|Secondary|Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)|Onset of response is defined as the time between the first dose of study therapy and the date when measurement criteria are first met for global best overall response of partial (PR) or complete (CR), whichever occurs first. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions.|From Day 1, first dose to a maximum of 4.2 months|All participants who received at least 1 dose of ipilimumab. n=number of participants with a best overall response of CR or PR.|||Months||Full Range|Median
1234635|NCT00623766|Secondary|Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Continuously from Day 1, first dose, to 70 days following last dose of ipilimumab|All participants who received at least 1 dose of ipilimumab|||Participants|||Number
1234636|NCT00623766|Secondary|Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)|OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated.|From first dose to Months 6, 12, 18, 24, and 36 months|All participants who received at least 1 dose of ipilimumab|||Probability of being alive||95% Confidence Interval|Number
1234637|NCT00623766|Secondary|Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)|PFS is defined as the time between the date of the first dose of study therapy and the date of progression or death, whichever occurs first. A patient who dies without reported prior progression will be considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS will be censored on the date of last evaluable tumor assessment. Participants who have not died and have no recorded postbaseline tumor assessment will be censored on the date of first dose of study therapy. Those who die without any recorded postbaseline tumor assessment will be considered to have progressed on the date of death.|From Day 1, first dose to the date of progression or death, whichever occurred first up to 22 months|All participants who received at least 1 dose of ipilimumab|||Months||95% Confidence Interval|Median
1234638|NCT00623766|Secondary|Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)|DOR is defined in patients whose global best overall response is complete (CR) or partial response (PR) as the time between the date of response of confirmed CR or PR, whichever occurs first, and the date of progressive disease or death, whichever occurs first. For patients who remain alive and have not progressed following response, duration of response will be censored on the date of last evaluable tumor assessment.|From Day 1, first dose to last tumor assessment up to 18.2 months|All participants who received at least 1 dose of ipilimumab|||Months||95% Confidence Interval|Median
1234639|NCT00623766|Secondary|Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)|BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria [irRC]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met.|From Day 1, first dose until the last tumor assessment, Week 12|All participants who received at least 1 dose of ipilimumab|||Percentage of participants||95% Confidence Interval|Number
1234640|NCT00623766|Secondary|Disease Control Rate by Immune-related Response Criteria (irRC)|Disease control rate is defined as the number of patients with a best overall response of immune-related (ir) complete response (irCR), partial response (irPR), or stable disease (irSD) divided by the total number of patients who received treatment. By irRC definition: irCR=complete disappearance of all index lesions. irPR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. irSD=does not meet criteria for irCR or irPR, in the absence of ir progressive disease (irPD). irPD=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline). CNS=central nervous system; non-CNS compartment=extracranial, or outside of the brain.|From Day 1, first dose to end of Week 12|All participants who received at least 1 dose of ipilimumab|||Percentage of participants||95% Confidence Interval|Number
1235225|NCT00619801|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1234641|NCT00623766|Primary|Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria|Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system.|From Day 1, first dose to end of Week 12|All participants who received at least 1 dose of ipilimumab|||Percentage of participants||95% Confidence Interval|Number
1234642|NCT00623727|Other Pre-specified|Percentage of Participants With Less Than 9 Total Bleeds Per Year in the Open Label Extension Period|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|6 months after start of open label extension period|Participants who completed open label extension period|||Percentage of participants|||Number
1234643|NCT00623727|Other Pre-specified|Total rFVIII Consumption Per Year|Total number of units per kg of study medication (rFVIII) administered to participant for one year. rFVIII is recombinant factor VIII, factor VIII is functional coagulation factor|up to one year|ITT population|||IU per kg||Full Range|Median
1234644|NCT00623727|Other Pre-specified|Percentage of Bleeds Treated by Various Numbers of Injections|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|PP Population|||percentage of bleeds|||Number
1234645|NCT00623727|Other Pre-specified|Number of Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Number of bleeds 3 weeks after the first infusion per 12 months|up to one year|PP population|||bleeds per year||Full Range|Median
1234646|NCT00623727|Secondary|Number of Joint Bleeds Per Participant Per Year in Responders|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Responders were the subjects with less than 9 total bleeds per year|up to one year|PP population in responders|||Joint bleeds per year||Full Range|Median
1234647|NCT00623727|Secondary|Percentage of Participants With Less Than 5 Joint Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|PP population|||Percentage of participants|||Number
1234648|NCT00623727|Primary|Percentage of Participants With Less Than 9 Total Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|Per protocol (PP) population|||Percentage of participants|||Number
1234649|NCT00623714|Secondary|Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL)||Baseline and 24 hours post allergen challenge|All Patients as Treated|||pg/mL||95% Confidence Interval|Geometric Mean
1234650|NCT00623714|Primary|Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)||Baseline and 24 hours post allergen challenge|All Patients as Treated|||pg/mL||95% Confidence Interval|Geometric Mean
1234651|NCT00623636|Secondary|Number of Subjects With Pain Relief at 10 Minutes|"Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
1234652|NCT00623636|Secondary|Number of Subjects With Pain Relief at 4 Hours|"Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|4 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
1234653|NCT00623636|Secondary|Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours|"The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included.~The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from the first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
1234666|NCT00623597|Secondary|Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count|Change from baseline in CD8+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD8+ lymphocyte count was derived as follows: Change from baseline = (CD8+ count at week 24/48) – (CD8+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||count/uL||Standard Deviation|Mean
1234654|NCT00623636|Secondary|Number of Subjects With Sustained Pain Relief From 2 to 24 Hours|"Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|From 2 to 24 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
1234655|NCT00623636|Primary|Number of Subjects Nausea Free at 2 Hours From Time of First Dose|"Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
1234656|NCT00623636|Primary|Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose|"Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
1234657|NCT00623636|Primary|Number of Subjects Photophobia Free at 2 Hours From Time of First Dose|"Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
1234658|NCT00623636|Primary|Number of Subjects With Pain Relief at 2 Hours From Time of First Dose|"Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
1234659|NCT00623597|Primary|Change In Hematuria, Glycosuria And Proteinuria From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||[0 to 4+]||Standard Deviation|Mean
1234660|NCT00623597|Primary|Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||mmol/L||Standard Deviation|Mean
1234661|NCT00623597|Primary|Change In Total Bilirubin, Creatinine, Uric Acid From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||umol/L||Standard Deviation|Mean
1234662|NCT00623597|Primary|Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||U/L||Standard Deviation|Mean
1234663|NCT00623597|Primary|Change In Red Blood Cell (RBC) Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||10*12/L||Standard Deviation|Mean
1234664|NCT00623597|Primary|Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||10*9/L||Standard Deviation|Mean
1234665|NCT00623597|Primary|Change In Hemoglobin, Total Protein And Total Albumin From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||g/L||Standard Deviation|Mean
1234741|NCT00623194|Secondary|Diabetic Ketoacidosis|Diabetic ketoacidosis requiring hospitalisation|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||events|||Number
1234667|NCT00623597|Secondary|Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count|Change from Baseline in CD4+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week 24/48) – (CD4+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||count/uL||Standard Deviation|Mean
1234668|NCT00623597|Secondary|Number of Participants With Virological Failure|Virological failure was defined as: viral load >= 400 copies/mL on two consecutive occasions (missing visits was assumed to be above 400 copies/mL). The number of participants classified as virological failure by Age Group and viral load (≤ 10,000 copies, >10,000 copies) were presented.|From Week 12 till Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
1234669|NCT00623597|Secondary|Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA )|The number of participants experiencing a greater than 1 log drop from baseline (day 1) (log 10 transformed) were reported|From Week 8 till Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
1234670|NCT00623597|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA) <50 Copies/mL|The number of participants with HIV-1 RNA results <50 copies/mL were reported.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
1234671|NCT00623597|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA) <400 Copies/mL|The number of participants with HIV-1 RNA results <400 copies/mL were reported|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
1234672|NCT00623597|Secondary|Change From Baseline in Mean Human Immunodeficiency Virus Viral Load|Change from baseline in plasma HIV-1 RNA was derived as Change from baseline = Log10 (HIV-1 RNA at week x) – Log10 (HIV-1 RNA at baseline)|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population (SAP) comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||log10 copies/mL||Standard Deviation|Mean
1234673|NCT00623597|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir|The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of ritonasvir was normalized to a dose of 100 mg/kg.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen).|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||h*ug/mL||Standard Deviation|Mean
1234674|NCT00623597|Secondary|Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was normalized to a dose of 50 mg/kg for Saquinavir and100 mg/kg for Ritonavir.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||ng/mL||Standard Deviation|Mean
1234675|NCT00623597|Secondary|Plasma Trough Concentrations (Ctrough) for Ritonavir|Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Ritonavir was normalized to a dose of 100 mg/kg.|Pre-dose at Weeks 8, 12, 24|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||ng/mL||Standard Deviation|Mean
1234676|NCT00623597|Primary|Change In Hematocrit From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||fraction||Standard Deviation|Mean
1234677|NCT00623597|Primary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|From Baseline (Day 1) till Week 48 and Follow-up (Week 52)|The Safety Analysis Population (SAP) comprised all participants who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
1234678|NCT00623597|Primary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir|The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).|The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||h*ug/mL||Standard Deviation|Mean
1234679|NCT00623597|Primary|Plasma Trough Concentrations (Ctrough) for Saquinavir|Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg.|Pre-dose at Weeks 8, 12, 24.|The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||ng/mL||Standard Deviation|Mean
1234680|NCT00623545|Secondary|Weight Loss After Administration of Exenatide.|Body weight after overnight fast in light clothing|3 months||||kg||Standard Deviation|Mean
1234681|NCT00623545|Primary|Change in Energy Intake Measured Before Treatment and at the End of Treatment.|Energy intake is as calculated from energy expenditure as measured by doubly labeled water and change in body energy stores before and at the end of treatment. Units are kcal/d.|3 months|Those that completed baseline and final measurements.|||kcal/d||Standard Deviation|Mean
1234682|NCT00623506|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability,sleep,weight/appetite change,and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity).|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using LOCF.|||units on a scale||Standard Error|Mean
1234683|NCT00623506|Secondary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores (Week 2 minus Week 10) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using LOCF.|||units on a scale||Standard Error|Mean
1234684|NCT00623506|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|Mean change scores (Week 2 minus Week 10) to assess cognitive changes. The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Mean
1234685|NCT00623480|Other Pre-specified|Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A|The Haemo-QoL-A total score as well as each of its domains have a range between 0 (worst Quality of Life) and 100 (best Quality of Life) points. Therefore, a higher Haemo-QoL-A score denotes greater Quality of Life.|Baseline and 3 years|Full Analysis Set|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1234686|NCT00623480|Secondary|Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale|The total joint score is derived for each of six joints: left and right sides for knees (score: 0-25), ankles (score: 0-25), and elbows (score: 0-21). Higher CAJAS (Colorado Adult Joint Assessment Scale) score denotes greater joint structure damage thus a positive change from baseline means worsening. CAJAS total score is the sum of all 6 joints, ranging from 0 (best possible outcome) to 142 (worst possible outcome).|Baseline and 3 years|Full Analysis Set|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1234687|NCT00623480|Secondary|Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.|The Extended MRI Scale total score has a range between 0 (normal unaffected joint) to 45 (maximal joint damage) points. It is composed of 2 domains, the soft tissue domain with a maximum of 9 points and the osteochondral domain with a maximum of 36 points. A single score for each subject was to be calculated from the sum of both domains and the average over all joints for the Extended MRI endpoint. Higher MRI score denotes greater joint structure damage thus a positive change from baseline means worsening.|Baseline and 3 years|Full Analysis Set|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1234688|NCT00623480|Primary|Bleeding Frequency (Number of Total Bleeds)||After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days)|ITT (Intent-to-treat) Population|||Bleeds||Full Range|Median
1234689|NCT00623467|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|FAS|||scores on a scale||Standard Deviation|Mean
1234690|NCT00623467|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|FAS|||scores on a scale||Standard Deviation|Mean
1234691|NCT00623467|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234692|NCT00623467|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234693|NCT00623467|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234694|NCT00623467|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234695|NCT00623467|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234696|NCT00623467|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234697|NCT00623467|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234698|NCT00623467|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234768|NCT00622895|Secondary|Incidence of Disease-modifying Antirheumatic Drugs (DMARDs) Initiated Post Transplant to Modify Disease|Percent of patients treated with DMARDS after allogeneic transplant in order to treat scleroderma disease signs and symptoms.|Up to 5 years post-transplant|3 patients enrolled were evaluable.|||Participants|||Count of Participants
1234699|NCT00623467|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1234700|NCT00623467|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1234701|NCT00623467|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1234702|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234703|NCT00623467|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234704|NCT00623467|Secondary|Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. The data for contrast enhancement - gadobutrol combined was shown below.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234705|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234706|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234707|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234708|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234709|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234710|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234711|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234712|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234713|NCT00623467|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|FAS|||lesions||Standard Deviation|Mean
1234714|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|"The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible. The data for contrast enhancement - unenhanced were not collected for the clinical investigators."|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234715|NCT00623467|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The 3 blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|FAS|||lesions||Standard Deviation|Mean
1234716|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1236815|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1234717|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234718|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1234719|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced magnetic resonance imaging (MRI) in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI and combined unenhanced and gadobutrol-enhanced MRI, excluding the sample participants (the first participant from each study site).|||scores on a scale||Standard Deviation|Mean
1234720|NCT00623441|Primary|MACE (Major Adverse Cardiac Events)|MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))|12 Months|Intention to Treat (ITT)|||Percentage of participants|||Number
1234721|NCT00623428|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as incapacitating with inability to work or perform normal daily activity. A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above."|From Week 1 through Week 72.||||participants|||Number
1234722|NCT00623428|Secondary|Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment|Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.|12 weeks after actual end of treatment (range from Week 36 to Week 60)|All randomized patients.|||percentage of participants|||Number
1234723|NCT00623428|Primary|Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment|Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.|24 weeks after actual end of treatment (range from Week 48 to Week 72).|All randomized patients.|||percentage of participants|||Number
1234724|NCT00623428|Secondary|Percentage of Participants With Virological Relapse|"Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.~Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.~Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end."|End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).|Randomized patients with virological response at the end of treatment and at least one post-treatment HCV RNA measurement.|||percentage of participants|||Number
1234725|NCT00623428|Secondary|Percentage of Participants With Virological Response at End of Treatment|Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.|End of Treatment (Week 24 and Week 48 for each treatment group respectively).|All randomized patients. A backward imputation approach was used when the HCV RNA measurement at end of treatment was missing and HCV RNA was <15 IU/mL at the first measurement after the end of treatment time window (the patient was regarded as having virological response at end of treatment).|||percentage of participants|||Number
1234726|NCT00623428|Secondary|Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation|"Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.~Participants without Week 72 measurements were considered non-responders in the analysis."|Week 72|All randomized patients.|||percentage of participants|||Number
1234727|NCT00623428|Primary|Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment|"Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.~Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis."|24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.|All randomized patients.|||percentage of participants|||Number
1234728|NCT00623233|Secondary|1-Year Overall Survival (OS) Rate|OS was measured from the date of first dose to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date for a particular analysis, OS duration was censored for that analysis at the date of participant's last study contact prior to that cut-off date. The 1-year survival rate (percentage of participants who were alive at 1 year) was estimated from OS data.|Baseline to death from any cause, 1 year|The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=25; censored participants=27.|||percentage of participants||95% Confidence Interval|Number
1234729|NCT00623233|Secondary|Number of Participants With Adverse Events (AEs); Pharmacology Toxicities|A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.|Baseline, every cycle (every 14 days) up to 34 months|The safety population was the treated population and included all participants who received at least 1 dose of study therapy.|||participants|||Number
1234730|NCT00623233|Secondary|Overall Tumor Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: complete response (CR)=disappearance of all target lesions; partial response (PR)=30% decrease in sum of longest diameter of target lesions; progressive disease (PD)=20% increase in sum of longest diameter of target lesions; stable disease=small changes that do not meet above criteria. ORR=proportion of participants who achieved a confirmed best response of CR or PR (responders). ORR=number of participants with CR or PR /number of participants qualified for tumor response analysis (per protocol population).|Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months).|The per protocol (PP) population included all intent-to-treat (ITT) participants who met the following criteria: histological or cytological diagnosis of breast cancer; presence of measurable disease at baseline per RECIST criteria; had at least 1 dose of study drug; no current systemic anti-tumor treatment other than protocol-specified therapy.|||proportion of responders||95% Confidence Interval|Number
1234731|NCT00623233|Primary|Progression Free Survival (PFS) Time|PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.|Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).|The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=41; censored participants=11.|||months||95% Confidence Interval|Median
1234732|NCT00623194|Secondary|Vital Signs: Pulse|Pulse at week 104|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||beats/minute||Standard Deviation|Mean
1234733|NCT00623194|Secondary|Vital Signs: Blood Pressure|Blood pressure (Systolic and Diastolic) after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||mmHg||Standard Deviation|Mean
1234734|NCT00623194|Secondary|Fundoscopy/Fundus Photography|"Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant~Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant"|at 52 weeks and at 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||participants|||Number
1234735|NCT00623194|Secondary|Laboratory Values: Leukocytes and Thrombocytes|Leukocytes and Thrombocytes after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||10^9/L||Standard Deviation|Mean
1234736|NCT00623194|Secondary|Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)|Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||U/L||Standard Deviation|Mean
1234737|NCT00623194|Secondary|Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)|Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||mmol/L||Standard Deviation|Mean
1234738|NCT00623194|Secondary|Laboratory Values: Creatine Serum Umol/L|Creatine serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||Umol/L||Standard Deviation|Mean
1234739|NCT00623194|Secondary|Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)|Albumin Serum and Total Protein Serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||g/dL||Standard Deviation|Mean
1234740|NCT00623194|Secondary|Insulin Dose|Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||U/kg||Standard Deviation|Mean
1234742|NCT00623194|Secondary|SD-score (Z-score) for Body Weight|Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||SD-scores||Standard Deviation|Mean
1234743|NCT00623194|Secondary|BMI (Body Mass Index)|BMI (Body Mass Index) after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||kg/m^2||Standard Deviation|Mean
1234744|NCT00623194|Secondary|Hypoglycaemic Episodes|"Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.~Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment."|Weeks 0-104|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||events|||Number
1234745|NCT00623194|Secondary|Fasting Plasma Glucose Values|FPG (Fasting Plasma Glucose) values after 104 weeks.|At 104 weeks|Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.|||mmol/L||Standard Deviation|Mean
1234746|NCT00623194|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.|At 104 weeks|Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1234747|NCT00623194|Secondary|Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies|Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.|At 0, 52 and 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension period.|||Percent bound of total||Standard Error|Mean
1234748|NCT00623194|Primary|Insulin Detemir-insulin Aspart Cross-reacting Antibodies|Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.|week 0, 52 and 104|"Full analysis set 146 (100%), safety analysis set 146 (100%)~The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.~The safety analysis set included all subjects with a signed informed consent who were exposed in the extension."|||Percent bound of total||Standard Error|Mean
1234749|NCT00623181|Other Pre-specified|Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection|"Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia.~Data for this outcome were based on the first vaccination type, intradermal or intramuscular."|Days 0 through 7 post-vaccination|Safety parameters were assessed in all enrolled and vaccinated subjects, intend-to-treat population.|||Participants|||Number
1234750|NCT00623181|Other Pre-specified|Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection|"Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Days 0 through 7 post-vaccination|Safety parameters were assessed in all enrolled and vaccinated participants, intend-to-treat population.|||Participants|||Number
1234751|NCT00623181|Primary|Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination|"Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Days 0, 3, and 7 after vaccination||||Scores on a scale||Standard Deviation|Mean
1234752|NCT00623181|Primary|Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination|"Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Day 0 and up to 7 days post-vaccination|Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route.|||Participants|||Number
1234753|NCT00623103|Secondary|UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)|Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).|From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)|The Safety population consisted of all patients who have received at least one dose of study drug and have had at least 1 safety measurement after baseline. n=indicates patients with observation during different timepoints.|||Score||Standard Deviation|Mean
1234754|NCT00623103|Secondary|Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|"The 23 item caregiver-based ADL scale of the dementia Alzheimer’s disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items.~The change from baseline was calculated such that a positive change indicates an improvement."|From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF).|||Score||Standard Deviation|Mean
1234755|NCT00623103|Secondary|Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).|At Week 16, 24, 52 and 76 (or early discontinuation)|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)|||Score||Standard Deviation|Mean
1234756|NCT00623103|Secondary|Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.|From Baseline to Weeks 16, 24, 52 and 76|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)|||Score on a scale||Standard Deviation|Mean
1234757|NCT00623103|Secondary|Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline|Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention [0-37], Initiation/Perservation [0-37] (performing alternating movements), Construction [0-6] (copying designs), Conceptualization [0-39] (similarities) and Memory [0-25] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.|From Baseline to Weeks 16, 24, 52 and 76|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)|||Score on a scale||Standard Deviation|Mean
1234758|NCT00623103|Secondary|Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.|From Baseline to Weeks 8, 16, 24, 52 and 76|"Safety population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. n in each of the categories is the number of participants at each time point with non-missing baseline and post-baseline measurements."|||Score on a scale||Standard Deviation|Mean
1234759|NCT00623103|Primary|Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)|The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.|76 Weeks|Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
1234760|NCT00623103|Primary|Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)|The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.|76 Weeks|Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
1234761|NCT00623012|Secondary|Disease Free Survival|achieved disease free in regard to leukemia|up to 10 weeks||||participants|||Number
1234762|NCT00623012|Secondary|Overall Survival|achieved overall survival in regard to leukemia|up to 10 weeks||||participants|||Number
1234763|NCT00623012|Primary|Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.|Percentage of patients free from graft versus host disease|up to 8 weeks||||percentage of patients|||Number
1234764|NCT00622908|Secondary|Eradication of Baseline Pathogens Day 4 (+/- 1 Day)|Bacterial species eradication of baseline bacterial infection|Visit 2 - Day 4 (+/- 1 day)|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.|||Participants|||Number
1234765|NCT00622908|Secondary|Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)|The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.|Visit 2 - Day 4 (+/- 1 day)|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.|||Participants|||Number
1234766|NCT00622908|Primary|Eradication of Baseline Pathogens (Day 8 or 9)|Bacterial species eradication of baseline bacterial infection|Visit 3 - Day 8 or day 9|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.|||Participants|||Number
1234767|NCT00622908|Primary|Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)|Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.|Visit 3 - day 8 or 9|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.|||Participants|||Number
1236816|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL/hr||Standard Deviation|Mean
1234769|NCT00622895|Secondary|Incidence and Severity of Graft-versus-host Disease (GVHD)|The grading of acute and chronic GVHD will follow previously published guidelines and according to institutional standard of practice but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and SSc involve the skin and the gastrointestinal tract, all diagnostic biopsies of these organs will be centrally reviewed by a study pathologist.|Up to 5 years post-transplant|"1 patient out of the 3 patients enrolled was evaluable for both acute and chronic GVHD. The grade of acute GVHD ranges from 0 to 4. Minimum score of 0 is normal or no GVHD. Maximum score of 4 is fatal GVHD.~Chronic GVHD minimum score is 0 (none), maximum score 3: extensive and severe."|||units on a scale|||Number
1234770|NCT00622895|Secondary|Incidence of Graft Rejection|Engraftment is defined as achieving > 5% donor peripheral blood T cell chimerism by Day 56 after HCT. Primary graft failure is defined as a donor peripheral blood T cell chimerism peak of < 5% by Day 56 post-HCT. Methodological requirements for chimerism are as defined by institutional standard of practice. Secondary Graft Failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood T cell chimerism < 5% as demonstrated by a chimerism assay|Up to day +56||||Participants|||Count of Participants
1234771|NCT00622895|Secondary|Skin Score|The skin score measure is a scale: the name of the scale is the modified Rodnan skin score (mRSS). Total score of mRSS is from 0 to 51. Higher values represents worse skin score. Highest value is 51, represents very hidebound tight thick skin. Lowest value is 0, represent normal skin, no tightness.|Up to 5 years post-transplant|One patient was evaluated at baseline and at 5 years post-transplant. Skin score was evaluated using modified Rodnan skin score (mRSS).|||units on a scale (mRSS)|||Number
1234772|NCT00622895|Secondary|Quality of Life as Assessed by the Medical Outcome Short Form (36) Health Survey Instrument (SF-36)|The Medical Outcome Short Form (36) Health Survey instrument (SF-36) is a general assessment of health quality of life with eight components: physical functioning, role limitations due to physical health, pain index, general health perceptions, vitality, social functioning, role limitations due to emotional problems and Mental Health Index. Each domain is positively scored, indicating that higher scores are associated with positive outcome.|Up to 5 years|"Pre-transplant (baseline) evaluation of physical functioning. Score from 0 to100 with 0 perfect health and 100 poor health.~The pre-transplant (baseline) evaluation was completed by study participant. The participant did not complete the 5 year post transplant evaluation.~The 5 year post-transplant SF32 form was not completed by the patient."|||units on a scale|||Number
1234773|NCT00622895|Secondary|Quality of Life as Assessed by the Modified Scleroderma Health Assessment Questionnaire (SHAQ)|The questionnaire includes measure of quality of life and measure of the scale of skin tightness, activity level and function specifically designed for patients with systemic sclerosis|Up to 5 years|One patient completed the pre-transplant and 5 year post transplant SHAQ (scleroderma health assessment questionnaire). Score range from 0 to 3. Minimum score: Score of 0 is excellent health. Maximum score: score of 3 is most severely impaired, poor quality of life.|||units on a scale|||Number
1234774|NCT00622895|Secondary|The Percent of Participants With Definite and Probable Viral, Fungal, and Bacterial Infections|The percent of participants with definite and probable viral, fungal, and bacterial infections after transplant|Up to 5 years||||Participants|||Count of Participants
1234775|NCT00622895|Secondary|Regimen-related Toxicity (Greater Than or Equal to Grade III) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|"Grades 3, 4 and 5 adverse events will be tracked from the start of mobilization or conditioning until day +100 after transplant or until patient departure from the center, whichever occurs first.~Certain adverse events are usual and expected after transplant and will only be reported if they are > Grade 4. Some Grade 4 events that are routinely expected (i.e. pancytopenia) will not be reported."|Up to 5 years|3 patients received umbilical cord blood (UCB) transplant.|||Participants|||Count of Participants
1234776|NCT00622895|Secondary|Treatment-related Mortality|Defined as death occurring at any time after start of allogeneic HCT and definitely or probably resulting from treatment given in the study and not associated with disease progression.|From time of transplant to 5 years||||Participants|||Count of Participants
1234777|NCT00622895|Secondary|Overall Survival|Event is defined as death due to any cause.|Up to 5 years|survival of patients after UCB|||Participants|||Count of Participants
1234778|NCT00622895|Secondary|EFS|event-free survival after umbilical cord blood transplant|5 years||||Participants|||Count of Participants
1234779|NCT00622895|Primary|Event-free Survival (EFS)|The events will be defined as any one of the following: death; respiratory failure; renal failure, as defined by chronic dialysis > or = 6 months or kidney transplantation; occurrence of cardiomyopathy, confirmed by clinical CHF (New York Class III or IV) or LVEF < 30% by echocardiogram, sustained for at least 3 months despite therapy; organ dysfunction specific events must be documented on at least two occasions > or = 3 months apart, or sustained for a 3-month period (documented from the first occurrence).|2 years|UCB transplant recipients|||Participants|||Count of Participants
1234780|NCT00622869|Secondary|Change in Renal Function From Randomization to Months 12 and 24|"Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.~The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported."|Randomization to Month 24|Intent-to-treat population: All randomized patients.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
1234805|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component|Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||milliliter||Standard Error|Least Squares Mean
1234781|NCT00622869|Secondary|Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24|"tBPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3, which was treated with anti-rejection therapy. Liver biopsies were collected for all cases of suspected acute rejection preferably within 24 hours, at the latest within 48 hours, whenever clinically possible. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.~The incidence rates of tBPAR were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 24|Intent-to-treat population: All randomized patients.|||Percentage|||Number
1234782|NCT00622869|Secondary|Incidence Rate of Composite Efficacy Failure From Randomization to Month 24|"Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death.~The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 24|Intent-to-treat population: All randomized patients.|||Percentage|||Number
1234783|NCT00622869|Primary|Incidence Rate of Composite Efficacy Failure From Randomization to Month 12|"Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.~The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 12|Intent-to-treat population: All randomized patients.|||Percentage of participants|||Number
1234784|NCT00622739|Secondary|Children's Depression Rating Scale||Weekly|||||||
1234785|NCT00622739|Secondary|AIMS (Abnormal Involuntary Movement Scale)||Weekly|||||||
1234786|NCT00622739|Secondary|SAFTEE (Side Effects Rating Scale)||Weekly|||||||
1234787|NCT00622739|Secondary|Clinical Global Impressions (CGI) Scale||Weekly|||||||
1234788|NCT00622739|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.|6 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
1234789|NCT00622726|Secondary|Visual Acuity|The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.|Age 7 years.|||||||
1234790|NCT00622726|Secondary|Myopia in Zone I and Posterior Zone II of Infant Eyes|Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.|2.5 years of age|As of 6/2013, there were 13 deaths/ 26 eyes. Exclusions from surviving 137 infants/ 274 eyes: 6 infants/19 eyes with intraocular surgery--leaving: 131 infants/ 255 eyes; 14 infants/ 21 eyes had recurrence and 22 infants/ 44 eyes were lost to follow-up--leaving: 95 infants/ 190 eyes. Thus, only the refractions on these infants/ eyes are given.|||Diopters|Eyes|Standard Deviation|Mean
1234791|NCT00622726|Primary|Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment|"For Bevacizumab: Regrowth of new vessels at the site of the original extraretinal fibrovascular proliferation and/or at the site of the anterior edge of inner retinal vascularization.~For Laser: Regrowth of new vessels from the vessels at the anterior edge of inner retinal vascularization (remaining after retinal ablation)."|54 weeks postmenstrual age (window of 50 to 70 weeks)|Both eyes of all surviving infants were analyzed for recurrence: thus, 143 surviving infants and 286 eyes were analyzed. Reporting the number of eyes that developed recurrences|||eyes with recurrences|Eyes||Number
1234792|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score|The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||Scores on a scale||Standard Deviation|Mean
1234793|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function. A positive change score indicates improvement from baseline.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||scores on a scale||Standard Deviation|Mean
1234794|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score|The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget. Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16. A lower score indicates a more self-sufficient individual. A positive change from baseline score indicates worsening.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||scores on a scale||Standard Deviation|Mean
1235755|NCT00616239|Primary|Number of Participants Showing Improvement of Melasma Based on Mexameter Readings|The degree of participants pigmentation was measured from the affected and unaffected skin on both sides of the face using a narrowband reflectance spectrophotometer.|14 weeks||||participants|||Number
1234795|NCT00622713|Secondary|Clinical Global Impression of Change (CGI-C) by Physician|"The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The CGIC is rated on the following seven-point scale:very much improved, much improved, slightly improved, unchanged, slightly worsened, much worsened and very much worsened."|Baseline and week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. Last observation carried forward (LOCF) was used for missing values.|||Percentage of participants|||Number
1234796|NCT00622713|Primary|Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study|The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2.|24 weeks|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||Percentage of participants|||Number
1234797|NCT00622700|Other Pre-specified|Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);~Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin (TB) >1.5, 2, or 3 ULN;~ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first|Safety population as described in Outcome Measure 13. Here 'n' signifies the number of participants for the treatment group who had that parameter assessed at post-baseline.|||participants|||Number
1234798|NCT00622700|Secondary|Extension Treatment Period: Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.|From re-randomization up to 283 Weeks|Analysis was performed on Safety population. In Placebo/teriflunomide 7mg arm, 2 received 7mg in the core period; In Placebo/teriflunomide 14mg, 1 received 7mg in the core period, hence, they were included in the 7mg/7mg arm in extension period as treatment received in the core period for consistency.|||participants|||Number
1234799|NCT00622700|Secondary|Extension Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS)|Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.|From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])|ITT Population: all randomized participants in the extension who had at least 1 day IMP exposure. Participants were analyzed according to the treatment group allocated by the randomization in the core study followed by the re-randomized treatment group during the extension period.|||Percent probability||95% Confidence Interval|Number
1234800|NCT00622700|Secondary|Core Treatment Period: Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first|Safety population:all randomized participants exposed to study medication; analyzed according to drug actually received. In Placebo arm, 4 received teriflunomide 7mg & 2 received teriflunomide 14mg, hence they were included in respective teriflunomide arm. Participants who were randomized but not treated were excluded (2 in each teriflunomide arm).|||participants|||Number
1234801|NCT00622700|Secondary|Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108|FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
1234802|NCT00622700|Secondary|Core Treatment Period: Change From Baseline in EDSS at Week 108|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
1234803|NCT00622700|Secondary|Core Treatment Period: Time to 12-Week Sustained Disability Progression|The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than [>] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.|||percent probability||95% Confidence Interval|Number
1234804|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy|Atrophy was measured by MRI scan.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||percent change||Standard Deviation|Mean
1234806|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component|Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||milliliter||Standard Error|Least Squares Mean
1234807|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan|Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population, but including only participants who had post-baseline data.|||milliliters per scan|||Number
1234808|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)|Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population, but including only participants who had post-baseline data.|||lesions per scan||95% Confidence Interval|Number
1234809|NCT00622700|Secondary|Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108|The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||milliliter||Standard Error|Least Squares Mean
1234810|NCT00622700|Secondary|Core Treatment Period: Annualized Relapse Rate (ARR)|ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.|||relapses per patient year||95% Confidence Interval|Number
1234811|NCT00622700|Secondary|Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)|Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.|||percent probability||95% Confidence Interval|Number
1234812|NCT00622700|Primary|Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS)|Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|Intent-to-treat (ITT) population included all randomized participants who had at least 1 day study medication exposure. Participants were analyzed in the treatment group to which they were randomized.|||percent probability||95% Confidence Interval|Number
1234813|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|23 hours 45 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234814|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|23 hours 10 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234815|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|22 hours post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234816|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|20 hours 45 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234817|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|20 hours 10 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234818|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|14 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234819|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|11 hours 45 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234820|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|11 hours 10 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234821|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|10 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234822|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|8 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234823|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|6 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234824|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|5 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234825|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|4 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234851|NCT00622388|Secondary|Percent Change From Screening in Complement (CH50) Levels|CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure.|Screening and post-baseline visits (last visit was to occur 24 months post first dose)|FAS||||||
1234826|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|3 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234827|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|2 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234828|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|1 hour post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234829|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|30 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234830|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|15 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234831|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|5 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234832|NCT00622635|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|After 14 days|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1234833|NCT00622544|Secondary|Number of Subjects Developing Proteinuria During the Study Period|number of subjects developing proteinuria during the study period|2007-2009||||Participants|||Count of Participants
1234834|NCT00622544|Primary|Number of Subjects Developing Microalbuminuria During Study Period|number of subjects developing microalbuminuria during study period|2007-2009||||Participants|||Count of Participants
1234835|NCT00622518|Secondary|Side Effects of Therapy||5 days|Specific side effects were collected on patients whose parents returned study diaries (44 from ear drop group and 50 from standard care only group). In addition, parents were telephoned and asked about any serious side effects.|||participants|||Number
1234836|NCT00622518|Primary|Resolution of Otitis Media Symptoms|Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.|5 days|Data were analyzed on participants from whom data diaries were returned and who had data for an assessment. Data were analyzed on the following number of children at each assessment: 1- 50 standard care (SC),40 ear drop (ED) 2- 40SC 35ED 3- 49SC 37ED 4- 40SC 36ED 5- 44SC 35ED 6- 42SC 34ED 7- 44SC 34ED 8- 43SC 31ED 9- 44SC 33ED 10- 44SC 29ED|||units on a scale||Standard Deviation|Mean
1234837|NCT00622440|Secondary|Response With >75% Adherence|"Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)~No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, 48 weeks, 60 weeks|Evaluable participants who finished 48 weeks of treatement and reported >75% adherence to treatment|||participants|||Number
1234838|NCT00622440|Secondary|Response With >50% Adherence|"Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs reviewed by two clinicians, with decision by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in number of lesions with HSIL, or improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved)~No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, 48 weeks, 60 weeks|Evaluable participants who finished 48 weeks of treatement and reported >50% adherence to treatment|||participants|||Number
1234839|NCT00622440|Secondary|Estimate Effect Size for Phase 3 Trial|Secondary outcome stated in original protocol posting|Baseline, Week 60||2015-07-31|07/2015||||
1234840|NCT00622440|Secondary|Treatment Adherence|"Percent of recommended applications of cream reported in participant diary.~>75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent"|48 weeks|Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable.|||participants|||Number
1234841|NCT00622440|Primary|Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)|"Response assessed 12 weeks after treatment.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)~No Response (NR): HSIL present at weeks 48 & 60 on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline/screen, Week 48, Week 60||||participants|||Number
1234842|NCT00622427|Secondary|Change in Clinical Global Impression (CGI)|The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.|day 1 to day 14 of study drug||||percentage of change||Standard Deviation|Mean
1234843|NCT00622427|Primary|Change in Baseline to 2 Weeks ADHD Rating Scale|It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.|day 1 to day 14 of study drug||||percentage of change||Standard Deviation|Mean
1234844|NCT00622401|Secondary|To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.|This outcome was not measured because no patients were treated with rhIL-12.|3 years|This outcome was not measured because no patients were treated with rhIL-12.||||||
1234845|NCT00622401|Primary|Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine|Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.|3 years|All three patients experienced adverse events that were determined to be at least possibly related to the vaccine. The number of times each toxicity was observed is captured in the adverse events section.|||participants|||Number
1234846|NCT00622388|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion|Vss is the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7; up to 11 months after the last dose)|FAS. Data are presented for the number of participants attending each visit for whom the parameter can be calculated.|||liters||Geometric Coefficient of Variation|Geometric Mean
1234847|NCT00622388|Secondary|Clearance (CL) of Ofatumumab at the Eighth Infusion|CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are presented for the number of participants at each visit for whom the parameter can be calculated.|||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1234848|NCT00622388|Secondary|Half-life (T1/2) for Ofatumumab at the Eighth Infusion|t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are provided for the number of participants at each visit for whom the parameter could be calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
1234849|NCT00622388|Secondary|Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions|Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.|Visit 2 (Week 0) and Visit 9 (Week 7)|FAS. Data are provided for the number of participants attending each visit.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1234850|NCT00622388|Secondary|AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are provided for the number of participants attending each visit for whom the parameter value could be calculated. Participants contributing AUC(0-inf) data also contributed AUC(0-168) data.|||micrograms*hour/milliliter (µg.h/mL)||Geometric Coefficient of Variation|Geometric Mean
1234852|NCT00622388|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).|Time frame is from date of start of treatment to 2 years or withdrawal|FAS|||participants|||Number
1234853|NCT00622388|Secondary|Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits|B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.|Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)|FAS. Data are provided for the number of participants attending each visit.|||percent change in cells||Full Range|Median
1234854|NCT00622388|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18|HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported.|Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)|FAS. Data are provided for the number of participants attending each visit.|||participants|||Number
1234855|NCT00622388|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.|From date of start of treatment to 5 years or withdrawal|FAS||||||
1234856|NCT00622388|Secondary|Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy|Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.|From date of start of treatment to 5 years or withdrawal|FAS|||months||95% Confidence Interval|Median
1234857|NCT00622388|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from treatment start until progression or death.|From date of start of treatment to 2 years or withdrawal|FAS|||months||95% Confidence Interval|Median
1234858|NCT00622388|Secondary|Duration of Response|The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.|From date of start of treatment to 2 years or withdrawal|FAS. Only participants with CR or PR were analyzed.|||months||95% Confidence Interval|Median
1234859|NCT00622388|Primary|Number of Participants Classified as Responders and Non-responders for Objective Response|"According to the revised response criteria for malignant lymphoma, responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD."|6-month period from start of treatment (up to Week 24)|FAS|||participants|||Number
1234860|NCT00622388|Primary|Number of Participants With Objective Response|Objective response of ofatumumab treatment was assessed according to the “revised response criteria for malignant lymphoma.” Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.|6-month period from start of treatment (up to Week 24)|Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment|||participants|||Number
1234861|NCT00622336|Primary|Number of Participants With Adverse Events (AE) During the Extension Phase|An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.|Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.|||participants|||Number
1234862|NCT00622336|Secondary|Duration of Response|Duration of response based on the Myeloma response determination criteria developed by Bladé et al 1998 and defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on International Myeloma Working Group (IMWG) criteria.|Up to 70 months|Duration of response not analyzed per the sponsors decision.||||||
1234863|NCT00622336|Secondary|Myeloma Response Rate|Myeloma response determination criteria developed by Bladé et al 1998. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.|Up to 70 months|Myeloma Response Rate not analyzed per the sponsors decision.||||||
1234864|NCT00622336|Secondary|Time to Progression|Time to progression based on the myeloma response determination criteria developed by Bladé et al 1998 and is defined as the time from registration to the first documented progression. The progressive disease criteria included increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|Up to 70 months|Time to progression not analyzed per the sponsors decision.||||||
1234865|NCT00622336|Primary|Number of Participants With Adverse Events (AE) During the Treatment Phase|An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.|The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.|||participants|||Number
1234866|NCT00622284|Secondary|Change in Baseline Lipid Parameter Triglyceride at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.|||mg/dL||Standard Deviation|Mean
1234867|NCT00622284|Secondary|Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.|||mg/dL||Standard Deviation|Mean
1234868|NCT00622284|Secondary|Change in Baseline Lipid Parameter HDL at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.|||mg/dl||Standard Deviation|Mean
1234869|NCT00622284|Secondary|Change in Baseline Lipid Parameter Cholesterol at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.|||mg/dL||Standard Deviation|Mean
1234870|NCT00622284|Secondary|HbA1c Change at Week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.|Baseline and week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234871|NCT00622284|Secondary|HbA1c Change at Week 91||Baseline and week 91|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234872|NCT00622284|Secondary|HbA1c Change at Week 78||Baseline and week 78|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234873|NCT00622284|Secondary|HbA1c Change at Week 65||Baseline and week 65|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234874|NCT00622284|Secondary|HbA1c Change at Week 52||Baseline and week 52|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234875|NCT00622284|Secondary|HbA1c Change at Week 40||Baseline and week 40|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234876|NCT00622284|Secondary|HbA1c Change at Week 28||Baseline and week 28|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234877|NCT00622284|Secondary|HbA1c Change at Week 16||Baseline and week 16|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234878|NCT00622284|Secondary|HbA1c Change at Week 12||Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234879|NCT00622284|Secondary|HbA1c Change at Week 8||Baseline and week 8|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234880|NCT00622284|Secondary|HbA1c Change at Week 4|Difference of base percent value [Week x(%) - baseline (%)]|Baseline and week 4|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
1234881|NCT00622284|Secondary|2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104|This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.|Baseline and week 104|Patients in the FAS with a valid meal tolerance test (MTT) at baseline and at least one valid on-treatment MTT (MTT104).|||mg/dL||Standard Error|Mean
1234883|NCT00622284|Secondary|Percentage of Patients With HbA1c <6.5% at Week 104|The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 104|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.|||Percentage of patients|||Number
1234884|NCT00622284|Secondary|Percentage of Patients With HbA1c <6.5% at Week 52|The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 52|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.|||Percentage of patients|||Number
1234885|NCT00622284|Secondary|Percentage of Patients With HbA1c <7.0% at Week 104|The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 104|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.|||Percentage of patients|||Number
1234886|NCT00622284|Secondary|Percentage of Patients With HbA1c <7.0% at Week 52|The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 52|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.|||Percentage of patients|||Number
1234887|NCT00622284|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 104|This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.|Baseline and week 104|This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.|||mg/dL||Standard Error|Mean
1234888|NCT00622284|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 52|This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.|Baseline and week 52|This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.|||mg/dL||Standard Error|Mean
1234889|NCT00622284|Secondary|Incidence of Hypoglycaemic Events up to 104 Weeks|A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)|Week 104|The treated set consisted of all patients treated with at least one dose of study drug|||Patients|||Number
1234890|NCT00622284|Secondary|Incidence of Hypoglycaemic Events up to 52 Weeks|A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)|Week 52|The treated set consisted of all patients treated with at least one dose of study drug|||Patients|||Number
1234891|NCT00622284|Secondary|Body Weight Change From Baseline at Week 104|This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.|Baseline and week 104|This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.|||kg||Standard Error|Mean
1234892|NCT00622284|Secondary|Body Weight Change From Baseline at Week 52|This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.|Baseline and week 52|This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.|||kg||Standard Error|Mean
1234893|NCT00622284|Primary|HbA1c Change From Baseline at Week 104|This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.|Baseline and week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Error|Mean
1234894|NCT00622284|Primary|HbA1c Change From Baseline at Week 52|This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.|Baseline and week 52|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Error|Mean
1234895|NCT00622167|Primary|Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).|At time of imaging|Imaging 30 subjects was predicted to include enough plaques for analysis.|||plaques|Participants||Number
1234896|NCT00621985|Primary|Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens|Each subject was admitted for 2 24 hour hospitalizations, one on hydrocortisone and one on dexamethasone. Due to the timing of blood draws, the serum hormonal profile was only measured for 23 hours. The primary outcome was the Percent Difference in the Mean log transformed Area under the curve of 17-hydroxyprogesterone between the two regimens.|23 hours|Only four participants completed both the hydrocortisone and dexamethasone admissions.|||Log Mean Area Under the Curve||Standard Deviation|Log Mean
1234897|NCT00621959|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.|Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)|Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
1234898|NCT00621959|Primary|Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.|Over the total treatment period (14 days)|Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period|||points on a scale||Standard Deviation|Mean
1234899|NCT00621946|Primary|IDS-SR (Inventory of Depressive Symptomatology - Self-Report)|The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
1234900|NCT00621946|Primary|ACQ (Asthma Control Questionnaire)|The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
1234901|NCT00621946|Primary|HAM-D (Hamilton Rating Scale for Depression)|The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
1234902|NCT00621946|Primary|IDS-SR (Inventory of Depressive Symptomatology - Self-Report)|The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).|Baseline||||units on a scale||Standard Deviation|Mean
1234903|NCT00621946|Primary|ACQ (Asthma Control Questionnaire)|The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).|Baseline||||units on a scale||Standard Deviation|Mean
1234904|NCT00621946|Primary|HAM-D (Hamilton Rating Scale for Depression)|The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).|Baseline||||units on a scale||Standard Deviation|Mean
1234905|NCT00621933|Secondary|Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva|Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.|||Percentage of Species|||Number
1234906|NCT00621933|Secondary|Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid|Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.|||Percentage of Species|||Number
1234907|NCT00621933|Primary|Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva|Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.|||Percentage of Species|||Number
1234908|NCT00621933|Primary|Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid|Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.|||Percentage of Species|||Number
1234909|NCT00621855|Secondary|Laboratory Analyses|Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.|6 month treatment period + 2 week post treatment follow up|Treated set|||participants|||Number
1234923|NCT00621842|Secondary|Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP|The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
1236817|NCT00608491|Secondary|Change in Blood N- Terminal Pro- BNP||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1234910|NCT00621855|Secondary|Number of Participants With Bleeding Events During Total Observation Time|"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.~A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.~All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)."|6 month treatment period + 2 week post treatment follow up|Treated set|||participants|||Number
1234911|NCT00621855|Secondary|Change From Baseline in log10 D-dimer After 1 and 4 Weeks|Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.|Baseline and at 1 week and 4 weeks|Full Analysis Set (FAS)|||ratio||Standard Deviation|Geometric Mean
1234912|NCT00621855|Secondary|Number of Participants With Any Reduction of D-dimer Concentration||at 1 week and 4 weeks|Full analysis set - The full analysis set includes all randomised and treated patients who had at least one post-dose assessment of D-dimer available.|||participants|||Number
1234913|NCT00621855|Secondary|Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment|Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.|6 month treatment period + 2 week post treatment follow up|Treated set|||participants|||Number
1234914|NCT00621855|Secondary|Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment|Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment|6 month treatment period + 2 week post treatment follow up|Treated set|||participants|||Number
1234915|NCT00621855|Primary|Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time|"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.~A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.~All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)."|6 month treatment period + 2 week post treatment follow up|Treated set - The treated set includes all patients who received at least one dose of study medication.|||participants|||Number
1234916|NCT00621842|Secondary|Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.|||participants|||Number
1234917|NCT00621842|Secondary|Number of Participants Who Had a Fall That Required Medical Attention||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.|||participants|||Number
1234918|NCT00621842|Secondary|Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)|The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
1234919|NCT00621842|Secondary|Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)|The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
1234920|NCT00621842|Secondary|Number of Participants Who Fell at Least Once During the Study||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.|||participants|||Number
1234921|NCT00621842|Secondary|Change in Body Weight From Baseline||12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||lbs.||95% Confidence Interval|Mean
1234922|NCT00621842|Secondary|Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)|The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
1236818|NCT00608491|Secondary|Change in Uric Acid||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1234924|NCT00621842|Secondary|Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
1234925|NCT00621842|Secondary|Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)|The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
1234926|NCT00621842|Secondary|Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)|Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.|12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.|||participants|||Number
1234927|NCT00621842|Primary|Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
1234928|NCT00621777|Secondary|Effect of Treatment With Varenicline Versus Placebo on Health-related Quality of Life Indices in Recently Abstinent Smokers With Schizophrenia or Bipolar Disorder as Measured by the 12-Item Short Form Health Survey (SF-12)|The 12-Item Short Form Health Survey (SF-12) is a 12-item measure of perceived health status with good reliability, validity and correlation with other health measures. It is scored via a standard algorithm, with higher scores indicating better patient self perception of health, with a mean score of 50 and a standard deviation of 10 in a representative sample of the US population. The score is computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health. This was administered at baseline and end of study.|at week 52||||units on a scale||Standard Deviation|Mean
1234929|NCT00621777|Secondary|Safety and Tolerability of Extended Duration Pharmacotherapy When Added to Antipsychotic Medications in Schizophrenia Patients Who Have Recently Quit Smoking as Assessed by the Brief Psychiatric Rating Scale|Brief Psychiatric Rating Scale is a 24 item scale that is designed to assess positive and negative symptoms, and general psychopathology in people with serious mental illness. Each item is rated on a 7-point scale from not present to extremely severe; higher scores in a range of 24 to 168, indicate more severe symptoms Ratings are based on observation and patient report. The validity of the BPRS is generally high when compared with other measures of general psychopathology. It was administered at baseline, study weeks 12, 18, 26, 38, 52|at week 52|Only 63 subjects completed study visit #52, therefore only these subjects were analyzed at this time point for this variable|||units on a scale||Standard Deviation|Mean
1234930|NCT00621777|Primary|Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group||76 weeks||||participants|||Number
1234931|NCT00621764|Other Pre-specified|Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine|Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) up to 5 years after final vaccination|Geometric Mean Titers Against JE Antibodies were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1234932|NCT00621764|Other Pre-specified|Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination|Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) up to 5 years after final vaccination|Persistence of seroprotection to JE-CV antigens was assessed in the Full Analysis Set.|||Participants|||Number
1234933|NCT00621764|Secondary|Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination|JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers against the JE-CV vaccine antigens were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1234934|NCT00621764|Secondary|Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination|JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer < 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroconversion to the JE-CV vaccine antigens was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1234935|NCT00621764|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection|"12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.~2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities."|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection.|||Participants|||Number
1234936|NCT00621764|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection|"12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.~2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities."|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Participants|||Number
1234937|NCT00621686|Secondary|Overall Survival|Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up.|Time from date of registration to a) date of death due to any cause or b) last follow-up; Up to 15 years||||months||95% Confidence Interval|Median
1234938|NCT00621686|Secondary|Time to Progression|Time to progression (TTP) is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0 of the protocol, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Time to progression curves were compared via the log-rank test. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.|Time from study registration to a) date of disease progression, or b) last follow-up; Up to 15 years||||months||95% Confidence Interval|Median
1234939|NCT00621686|Primary|6-month Progression-free Survival|Primary Endpoint: 6-month progression free survival (PFS6): The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. To be classified as a success, an evaluable patient must be alive and progression-free 6 months after registration to the study. Patients who die prior to 6 months after study registration will be considered to have failed. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.|at 6 months||||proportion of participants||95% Confidence Interval|Number
1234940|NCT00621621|Secondary|AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.||After 250 subjects have been enrolled.||||participants||95% Confidence Interval|Number
1234941|NCT00621621|Primary|Device or Procedure Related AV Block Persistent Through Discharge From Hospital.||After 250 subjects have been enrolled.||||participants||95% Confidence Interval|Number
1234942|NCT00621582|Secondary|Physician Tolerability Assessment at Visit 3|The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)|8 weeks (Visit 3)|Full Analysis Set (FAS)|||Participants|||Number
1234943|NCT00621582|Primary|Patient Tolerability Assessment at Visit 3|"Patient tolerability assessment classified as Unsatisfied, Satisfied, Good and Very Good"|8 weeks (Visit 3)|Full Analysis Set (FAS)|||Participants|||Number
1234944|NCT00621582|Secondary|Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)|"The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8;~Represents number of participants who score good and excellent at visit 2 (2 weeks) and visit 3 (8 weeks)"|2 weeks (Visit 2 and 8 weeks (Visit 3)||||Participants|||Number
1234945|NCT00621582|Primary|Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)|"The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least).~Represents number of participants who score good and excellent at visit 1 (0 weeks) and visit 3 (8 weeks)"|0 weeks (Visit 1) and 8 weeks (Visit 3)|Sampling Method: Non-Probability Sample; conducted in primary care clinics.|||Participants|||Number
1234946|NCT00621543|Secondary|Percentage of Women Continuing IUD Use at 3 Months||3 months||||percentage of participants||95% Confidence Interval|Mean
1234947|NCT00621543|Primary|Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.||Three months||||percentage of participants||95% Confidence Interval|Mean
1234948|NCT00621530|Secondary|Neuropathic Pain Symptom Inventory|Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire to assess the degree of neuropathic characteristics of pain. This is termed the Neuropathic Pain Symptom Inventory which is scored 0-100 with 100 being the worst possible pain.|6 months|Some subjects were missed to follow up at different times|||units on a scale||Standard Deviation|Mean
1234949|NCT00621530|Secondary|McGill Affective Pain|Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the emotional component of their pain experience. This is termed the McGill Pain Affective Score and is scored from 0 to 12 with 12 being the highest pain emotional impact.|6 months|Some subjects were missed to follow up at different times|||units on a scale||Standard Deviation|Mean
1234950|NCT00621530|Secondary|McGill Pain Intensity|Pain was assessed 2 days and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the intensity of their pain experience. This is termed the McGill Pain Intensity Score and is scored from 0 to 33 with 33 being the highest pain intensity.|6 months|Some subjects were missed to follow up at different times|||units on a scale||Standard Deviation|Mean
1236819|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1234952|NCT00621530|Primary|Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery|Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery.|48 hours|These are data from the 57 subjects who remained in the study at the time of the primary outcome measure 48 hr after surgery|||area in centimeters squared||Full Range|Median
1234953|NCT00621517|Primary|Ordinal Scale(i.e., 1-8)of Symptom Severity||three weeks and six weeks|||||||
1234954|NCT00621517|Primary|Clinical Global Impression - Improvement Scale||three weeks and six weeks|||||||
1234955|NCT00621517|Primary|Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.|Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.|Baseline, three weeks, and six weeks|Intention to Treat|||points on a scale||Standard Deviation|Mean
1234956|NCT00621504|Secondary|Evaluate Safety||first dose, throughout the treatment period, and up to the TOC visit|||||||
1234957|NCT00621504|Secondary|Microbiological Re-infection/Recurrence at LFU||21 to 35 days after last dose of study drug|||||||
1234958|NCT00621504|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug|||||||
1234959|NCT00621504|Secondary|Clinical Relapse at Late Follow Up (LFU)||21-35 days after last dose of study drug|||||||
1234960|NCT00621504|Secondary|Clinical and Microbiological Response by Pathogen at TOC||8-15 days after last dose of study drug|||||||
1234961|NCT00621504|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)||8-15 days after last day of study drug|||||||
1234962|NCT00621504|Secondary|Microbiological Success Rate at Test of Cure (TOC)||8-15 days after last dose of study drug|||||||
1234963|NCT00621504|Secondary|Clinical Response at End of Therapy (EOT)||Last day of study drug administration|||||||
1234964|NCT00621504|Primary|Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations|"Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary~Failure: Any of the following:~Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy~Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia~Death wherein pneumonia (ie,CABP) was considered causative~Indeterminate: Inability to determine an outcome"|8 to 15 days after last dose of study drug|The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.|||participants|||Number
1234965|NCT00621348|Secondary|Incidence of Symptomatic Hypernatremia|Symptomatic hypernatremia is defined as serum sodium > 150 mmol/L and the presence of symptoms like altered sensorium, seizure, headache and vomiting not explained otherwise.|72 hrs|Intention to Treat analysis|||participants|||Number
1234966|NCT00621348|Secondary|Incidence of Symptomatic Hyponatremia|Defined as Hyponatremia (serum sodium < 130 mnol/L)and presence of symptoms attributed to hyponatremia such as altered sensorium, seizure, headache, and vomiting which can not be explained otherwise.|72 hrs||||participants|||Number
1234967|NCT00621348|Secondary|Incidence of Hypernatremia (Serum Sodium >150 mmol/L)||72 hrs|Intention To Treat analysis|||participants|||Number
1234968|NCT00621348|Primary|Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)||72 hrs|432 patients were eligible. 203 patients were excluded and 62 patients declined consent . Out of 167 patients, 58 patients were randomized to Arm 1, 53 to arm 2 and 56 to arm 3.Intention to treat analysis was used.|||participants|||Number
1234969|NCT00621322|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1234970|NCT00621322|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.~For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
1234971|NCT00621322|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
1234972|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234973|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234974|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234975|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234976|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234977|NCT00621322|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 210)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234978|NCT00621322|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234979|NCT00621322|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms included fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234980|NCT00621322|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
1234981|NCT00621296|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration||24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.||||participants|||Number
1234982|NCT00621257|Secondary|Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease|Percentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores. Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts.|12 months||||Participants|||Count of Participants
1234983|NCT00621257|Primary|Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease|"Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease.~25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores."|6 weeks||||ng/ml||Standard Deviation|Mean
1234984|NCT00621244|Secondary|Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)|All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))|Post dose to pre-dose (up to 3.5 years)|Full Analysis Set (with available samples for analysis)|||Percent Change||Standard Deviation|Mean
1234985|NCT00621244|Secondary|Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)|All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))|Post dose to pre-dose (up to 3.5 years)|Full Analysis Set (with available samples for analysis)|||Percent Change||Standard Deviation|Mean
1234986|NCT00621244|Secondary|Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y||Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)|Full Analysis Set|||Percentages of participants|||Number
1234987|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X||Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)|Full Analysis Set|||Percentages of participants|||Number
1234988|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y||Days 5, 8, end of study (up to 3.5 years)|Full Analysis Set|||Percentages of participants|||Number
1234989|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X|Reporting the number of patients with a reading at the timepoint in the dose group.|Days 1, 5, 8, 10, 15|Full Analysis Set N=number of participants analyzed. total n=number of patients with a reading at the timepoint in the dose group.|||Percentages of participants|||Number
1234990|NCT00621244|Secondary|Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1|MWF Every week schedule n = number of subjects with non-missing values.|Day 15/day 1|Pharmacokinetic set|||Ratio||90% Confidence Interval|Geometric Mean
1234991|NCT00621244|Secondary|Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15||Day 15|Pharmacokinetic set|||hour||Standard Deviation|Mean
1234992|NCT00621244|Secondary|Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15|From day 15 by dose with schedule: MWF every week|Day 15|Pharmacokinetic set|||ng/mL||Standard Deviation|Mean
1234993|NCT00621244|Secondary|Half Life of Panobinostat After the First Dose in Arms 1 and 2||Day 1|Pharmacokinetic set|||hour||Standard Deviation|Mean
1234994|NCT00621244|Secondary|Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2||Day 1|Pharmacokinetic set: Pharmacokinetic population consisted of all patients who provided at least one postdose PK plasma sample.|||ng/mL||Standard Deviation|Mean
1234995|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)|Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.|3.5 years|Full Analysis Set|||Participants|||Number
1234996|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Hodgkin’s Lymphoma (HD)|Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.|3.5 years|Full Analysis Set|||Participants|||Number
1234997|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase|Stage 2 did not open for enrollment.|1.2 years|Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease.|||Participants|||Number
1234998|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)|Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.|3.5 years|Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned.|||Participants|||Number
1234999|NCT00621244|Primary|Number of Participants DLT in Arm 2 in Dose Escalation Phase|"Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly).~A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD."|Cycle 1 (28-day treamtent cycle)|MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.|||Participants|||Number
1235000|NCT00621244|Primary|Number of Participants DLT in Arm 1 in Dose Escalation Phase|Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.|Cycle 1 (28-day treatment cycle)|MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1.|||Participants|||Number
1235001|NCT00621192|Primary|Key Safety Endpoints|Safety assessments included death, seizure documentation (including correlation of serum meropenem level and seizures), strictures, perforation, wound dehiscence, short gut, development of extended beta lactamase infection, development of candidiasis, antimicrobial therapy failure|Up to 51 days (Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug)|Safety Population - The Safety Population includes all patients who receive any amount of meropenem.|||Participants|||Number
1235002|NCT00621192|Primary|Meropenem Clearance|Given the limited availability of blood for Pharmacokinetic (PK) assessments in this population a sparse sampling approach was utilized. Subjects were assigned to one of two Dose 1 sample collection schedules, “PK-odd” and “PK-even” based on birth date to ensure collection of PK data throughout the dose interval. In addition, PK samples were collected around approximately the 5th dose. Subjects that did not have Dose 1 PK samples could have steady-state (Dose 5) using the Dose 5 PK collection schedule.|Up to 7-8hrs post drug administration||||L/h/kg||Standard Deviation|Mean
1235003|NCT00621192|Primary|Deaths||Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug)|The Safety Population includes all patients who receive any amount of meropenem.|||Participants|||Number
1235004|NCT00621192|Primary|Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)|"The PCCS was derived by comparing clinical signs and symptoms prior to administration of the first dose of study drug and study Day 28.The elements of the PCCS include Mean BP,Temp,PaO2(mmHg)/FiO2,Lowest serum pH,seizures,Urine output,Cardiovascular inotrope support,C-reactive protein (CRP)and Abdominal girth.~Score - Asymptomatic to Asymptomatic 1;Asymptomatic to Worsening 0;Symptomatic to Worsening 0;Symptomatic to No change 0;Symptomatic to Improved 1;Symptomatic to Asymptomatic 1~If 7 or more of 10 signs received a score of 1, then the infant was considered a presumptive clinical cure.~GA stands for Gestational Age and PNA stands for Postnatal Age."|Average of 12 days (3 to 21 days)|The Efficacy Population includes all patients who have efficacy assessment (Clinical Signs) at Pre-Dose and Study Day 28 (or the day that the Day 28 assessments were taken).|||Participants|||Number
1235005|NCT00621153|Secondary|Compliance Levels at 4 Weeks and 8 Weeks of Therapy|Percent of the number of returened pills to the number of prescrited pills|8 weeks|||||||
1235006|NCT00621153|Secondary|Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE’s From Baseline (Randomisation) to the End of the Study (8 Weeks)|Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks|8 weeks|||||||
1235007|NCT00621153|Secondary|Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy|Change of hs-CRP from basline after 8 weeks|8 weeks|||||||
1235008|NCT00621153|Secondary|Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy|Changed SBP from baseline after 8 weeks|8 weeks|||||||
1235009|NCT00621153|Secondary|Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy|Percent of patients achieving goal of DBP|8 weeks|||||||
1235010|NCT00621153|Secondary|Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy|Percent of the patients achieving goal DBP and SBP after 4 weeks|4 weeks|||||||
1235011|NCT00621153|Secondary|Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy|Mean of the changed SBP from baseline after 4 weeks|4 weeks|||||||
1235012|NCT00621153|Primary|Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy|Mean of the changed DBP from baseline after 4 weeks|4 weeks||||mmHg||Standard Deviation|Least Squares Mean
1235013|NCT00621140|Secondary|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)|||mg/dL||Standard Error|Mean
1235014|NCT00621140|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1235015|NCT00621140|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||Percentage of Patients|||Number
1235016|NCT00621140|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%.|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1235017|NCT00621140|Secondary|Percentage of Patients With HbA1c<7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1235018|NCT00621140|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1235019|NCT00621140|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1235020|NCT00621140|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1235021|NCT00621140|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1235022|NCT00621140|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1235023|NCT00621140|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1235024|NCT00621140|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1235025|NCT00621140|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1235026|NCT00621140|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1235027|NCT00621049|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months||||months||95% Confidence Interval|Median
1235028|NCT00621049|Secondary|2-year Survival|Proportion of patients known to still be alive 2 years after coming on study|24 months||||percentage of participants|||Number
1235029|NCT00621049|Secondary|Safety|Adverse Events occuring in >15% of patients|2 years||||participants|||Number
1235030|NCT00621049|Primary|Disease-free Survival|The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.|1 year||||months||95% Confidence Interval|Median
1235031|NCT00621023|Secondary|Number of Patients With an Unacceptable Toxicity|Any of the following non-hematologic toxicities that causes a patient's therapy to be suspended or discontinued: Creatinine > 2x baseline value; serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), Total bilirubin > 2x the upper limit of normal; Febrile neutropenia; Uncontrolled infection; Hepatotoxicity defined as an increase in serum bilirubin, SGOT, or alkaline phosphatase to >5 times baseline value); nephrotoxicity (defined as serum creatinine >3.5 times the ULN); neurological impairment (defined as somnolence, seizures, or impaired mentation); severe peripheral neuropathy, or any non-hematologic grade 4 toxic event.|During the treatment period and for 30 days after last dose of study drug||||participants|||Number
1235032|NCT00621023|Secondary|Duration of a Complete or Partial Response Based on Number of People Who Responded.|Number of months a complete or partial response was maintained.|Up to 5 years or until death|||||||
1235033|NCT00621023|Primary|Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR)|Complete response and Partial response are defined using 2000 international working group (IWG) criteria. The Primary criteria for a CR is a repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia . A PR meets all the CR criteria except Blasts decreased by >50% over pretreatment, or a less advanced myelodysplastic syndrome (MDS) French American British (FAB) classification than pretreatment.|after 4 cycles of therapy||||participants|||Number
1235034|NCT00620945|Secondary|Mortality|Percentage of patients who died within 30 days of the procedure|30 days||||Participants|||Count of Participants
1235035|NCT00620945|Primary|Number of Participants Achieving High Flow Low Pressure on Cardiopulmonary Bypass|Percentage of patients who achieved high flow, low pressure on cardiopulmonary bypass|From time of cardiopulmonary bypass initiation until the time that high flow, low pressure on cardiopulmonary bypass was achieved, assessed up to 1 hour||||Participants|||Count of Participants
1235036|NCT00620854|Primary|Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)|This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.|0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB|Per protocol, only subjects who completed all 3 treatments were analyzed.|||% Change in Baseline CTx-1||Standard Error|Mean
1235037|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise|Straight Leg Raise (SLR): number of people that can perform a SLR at designated intervals|4 hours, 8 hours, 12 hours and 24 hours post-op||||participants|||Number
1235038|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion|Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort|24 hours post-op||||degrees||Standard Deviation|Mean
1235039|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance|Ambulation distance walked by participants 24-hours post-operatively|24 hours post-op||||Feet||Standard Deviation|Median
1235040|NCT00620828|Secondary|Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption|The PCA total dose at the 4-hour, 8-hour, 12-hour and 24-hour post-operative time points.|4 hours to 24 hours post-op||||micrograms||Standard Deviation|Mean
1235041|NCT00620828|Primary|Numeric Pain Score|Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).|Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection|per protocol|||units on a scale||Standard Deviation|Mean
1235042|NCT00620815|Secondary|Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit|"Frequency and functionality of vaccine antigen-specific CD4+ (cluster of differentiation 4) T cells was assessed in peripheral blood (PBMC) taken at days 1, 22 and 43 after in vitro stimulation with:~Library of 70 peptides spanning the whole H5 A/Vietnam/1194/2004 protein (H5 pool of 70 Vietnam) H5N1 subunit from A/Vietnam/1194/2004 (H5N1 Vietnam) H3N2 subunit from A/ Wisconsin/67/2005 (H3N2 Wisconsin) H1N1 subunit from A/Solomon Islands/3/2006 (H1N1 Solomon Islands) Polyclonal stimulus agonistic aCD3 mAb [monoclonal antibody (aCD3)].~The change in frequency of T-cells was measured."|Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43)|Analysis was done on full analysis set|||Mean cells per million total cells||95% Confidence Interval|Mean
1235043|NCT00620815|Secondary|Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.|"The Cell Mediated Immunity (CMI) response was evaluated in a randomly selected subgroup of approximately 92 subjects from all the vaccine groups out of a total of 601 enrolled subjects.~Frequency of circulating memory B cells (MBC), capable of differentiating in vitro into cell secreting IgG (Immunoglobulin G) antibodies specific for H5N1 (the subunit from A/Vietnam/1194/2004) or for H1N1 (the subunit from A/Solomon Island/3/2006) were determined by an ELISA-coupled limiting dilution assay.The frequency of H5N1-IgG MBC and H1N1-IgG MBC was expressed as percentages (%) of total IgG producing MBC."|Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43)|The analysis was done on Full analysis set|||Percentages of B-cell antibodies||95% Confidence Interval|Mean
1235044|NCT00620815|Secondary|Antibody Response Determined by HI and MN Assay.|Measurement of immunogenicity in terms of Geometric mean titers (GMTs) as determined by HI and MN assay.|Up to 43 days|The population was analyzed on Per protocol set|||titers||95% Confidence Interval|Mean
1235045|NCT00620815|Secondary|Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2|Measurement of immunogenicity in terms of percentage of subjects achieving a titre ≥ 40/area ≥ 25mm^2 after immunization as determined by HI (Haemagglutination Inhibition), MN(Microneutralization) and SRH assay.|Up to 43 days|The analysis was done on Per Protocol Set|||Percentages of subjects||95% Confidence Interval|Number
1235046|NCT00620815|Secondary|Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain|"Measurement of immunogenicity in terms of significant increase in antibody titer and Seroconversion.~Significant increase in antibody titer is defined as at least a four-fold increase from non-negative pre-vaccination serum (≥ 10) for HI or a 50% increase in area for SRH.~Seroconversion is defined as negative pre-vaccination serum / post-vaccination titer ≥40 for HI (area ≥25 mm2 for SRH)"|up to day 43|The population was analyzed on per protocol set.|||Percentage of subjects||95% Confidence Interval|Number
1235047|NCT00620815|Secondary|Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.|Systemic reactions were collected upto 7 days after 1st and 2nd vaccinations. All subjects were instructed to complete a diary card to record systemic reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.|7 days after 1st and 2nd vaccinations each|The analysis was performed on Per Protocol Safety Population|||Participants|||Number
1235048|NCT00620815|Secondary|Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination|Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.|Up to 7 days after 2nd vaccination|The analysis was performed on Safety Population|||Participants|||Number
1235049|NCT00620815|Secondary|Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination|Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. The table represents local reactions after first vaccination in each arm differently.|Up to 7 days after 1st vaccination|The analysis was performed on Safety Population|||Participants|||Number
1235050|NCT00620815|Primary|To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.|"The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence.~The statistical analysis was done based on the GMRs."|up to day 43|The analysis was done on Per Protocol Set (PPS)|||Area (mm^2)||95% Confidence Interval|Geometric Mean
1235051|NCT00620776|Secondary|50 Percent or Greater Reduction in PSWQ Score|Clinically significant change was defined on the PSWQ as an estimated (based on linear mixed effects model) endpoint score of less than 50.9. This score was calculated using the PSWQ normative data provided by Gillis, Haaga, and Ford (1995) and the baseline PSWQ mean and standard deviation (SD) from the current sample. The PSWQ mean and SD from the normative and current GAD samples were entered into the Jacobson et al. (1984) formula “c” for clinically significant change. This method provides a cutoff indicating whether or not the level of functioning by a patient is statistically more likely to be in the functional rather than the dysfunctional population.|Data collected as part of protocol 709012 at baseline, week 12, and week 24||||Participants|||Count of Participants
1235052|NCT00620776|Secondary|Clinical Response Rate|Clinical response on the HAM-A was defined as a 50% or greater reduction from baseline to last value with the 24-week open label medication phase.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24||||Participants|||Count of Participants
1235053|NCT00620776|Secondary|Mental Component Score of the 12-item Short Form Survey (SF-12)|The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235054|NCT00620776|Secondary|Physical Component Score of the 12-Item Short Form Survey (SF-12)|The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235055|NCT00620776|Secondary|Penn State Worry Questionnaire (PSWQ)|The Penn State Worry Questionaire is a 16-item inventory that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me). A total score is calculated (range = 16 to 80), with higher scores indicating greater worry.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235056|NCT00620776|Secondary|Quality of Life Subscale of the General Health Questionnaire (GHQ)|The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions. Patients completed the 12 quality of life questions (each on a 0 to 3 scale) on this questionnaire. Scores on the 12 items were added up to create summary score (range = 0 to 36). Higher scores indicate worse health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235057|NCT00620776|Secondary|Clinical Global Impression (CGI)-Improvement Score|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale (1= very much improved; 7 = very much worse) that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235058|NCT00620776|Secondary|Clinical Global Impression (CGI)-Severity Score|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale (1=normal; 7 = extremely ill) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at each time point differs due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235059|NCT00620776|Secondary|Hamilton Rating Scale for Depression (HAM-D)-17-item Score|The 17-item version of the HAM-D was used to assess severity of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.The total score is the sum of the 17 items, with a range from 0 to 50. A higher scores indicates greater depression. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Numbers analyzed at various time points differ due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235060|NCT00620776|Secondary|Hospital Anxiety Depression Scale (HAD)-Depression Score|The HAD was used to assess patients’ report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater depression.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Numbers analyzed at various time points differ due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235061|NCT00620776|Secondary|Hospital Anxiety Depression Scale (HAD)-Anxiety Score|The HAD was used to assess patients’ report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater anxiety.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Numbers analyzed at various time points differ due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235062|NCT00620776|Primary|Hamilton Anxiety Rating Scale (HAM-A)|The HAM-A was used to measure the severity of anxiety symptoms. The scale consists of 14 items; each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate and 25–30 moderate to severe anxiety. This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at various time points differ due to patient dropout.|||units on a scale||Standard Deviation|Mean
1235063|NCT00620763|Primary|Calcium Absorption|After 3 weeks equilibration to the diet, the 2-day menu was extrinsically labeled with Calcium-47 radiotracer and retention was monitored for 28 days by whole body scintillation counting. Percent Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic plot of percent Calcium-47 retained vs time.|18 weeks|Analysis included only the 16 volunteers that completed both dietary interventions.|||percentage of Calcium-47 absorbed||Standard Error|Mean
1235064|NCT00620750|Primary|Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections||4 months|Per protocol|||Percent of participants|||Number
1235065|NCT00620711|Primary|Cap Cooled to 12 Degrees Without Reducing Rectal Temperature|Yes/no|6 hours||||participants|||Number
1235066|NCT00620711|Primary|Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.|Measurement of number of participants able to obtain 12 degree cap temperature|60 minutes intervals|all analysized|||participants|||Number
1235086|NCT00620542|Secondary|Non-HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
1235067|NCT00620698|Secondary|Handheld Dynamometry|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months||||Coefficient of variation||95% Confidence Interval|Mean
1235068|NCT00620698|Secondary|ALS Functional Rating Scale|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months||||Coefficient of variation||95% Confidence Interval|Mean
1235069|NCT00620698|Primary|Electrical Impedance Myography|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months||||Coefficient of Variation||95% Confidence Interval|Mean
1235070|NCT00620659|Secondary|Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo|"The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with 'subjective sleepiness'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 (would never dose) to 3 (high chance of dozing). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse)."|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||units on a scale||Standard Error|Least Squares Mean
1235071|NCT00620659|Secondary|Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo|Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||units on a scale||Standard Error|Least Squares Mean
1235072|NCT00620659|Secondary|Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||Minutes||Standard Error|Least Squares Mean
1235073|NCT00620659|Secondary|Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||Minutes||Standard Error|Least Squares Mean
1235087|NCT00620542|Secondary|Triglycerides Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
1235074|NCT00620659|Primary|Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||Minutes||Standard Error|Least Squares Mean
1235075|NCT00620555|Secondary|Percent Change in Seizure Frequency|Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."|||Percent change||Full Range|Median
1235076|NCT00620555|Secondary|Responder Rate|Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."|||Percentage of participants||95% Confidence Interval|Number
1235077|NCT00620555|Secondary|Response Ratio|The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."|||Ratio||Standard Deviation|Mean
1235078|NCT00620555|Primary|Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|up to 53 weeks|Safety analysis set: All paticipants who have received at least one dose of the study drug.|||Participants|||Number
1235079|NCT00620542|Secondary|VLDL-C During the 104 Week Treatment Period|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
1235080|NCT00620542|Secondary|Apoliprotein B/Apolipoprotein A-1 Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Ratio||Standard Error|Least Squares Mean
1235081|NCT00620542|Secondary|Apolipoprotein A-1 Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
1235082|NCT00620542|Secondary|Apolipoprotein B Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
1235083|NCT00620542|Secondary|Non-HDL-C/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Ratio||Standard Error|Least Squares Mean
1235084|NCT00620542|Secondary|Total Cholesterol/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Ratio||Standard Error|Least Squares Mean
1235085|NCT00620542|Secondary|LDL-C/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Ratio||Standard Error|Least Squares Mean
1235088|NCT00620542|Secondary|HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
1235089|NCT00620542|Secondary|LDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
1235090|NCT00620542|Secondary|Total Cholesterol Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
1235091|NCT00620542|Secondary|Numbers of Patients Showing Regression in TAV|Regression defined as a change from baseline in TAV < 0|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Participants|||Number
1235092|NCT00620542|Secondary|Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)|Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mm^3||95% Confidence Interval|Median
1235093|NCT00620542|Secondary|Numbers of Patients Showing Regression in PAV|Regression defined as a change from baseline in PAV < 0|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Participants|||Number
1235094|NCT00620542|Primary|Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)|"Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as:~[sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD."|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Percent change||95% Confidence Interval|Median
1235095|NCT00620464|Primary|Bioequivalence of Implanon® and Radiopaque Implanon|"Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25.~Cmax (pg/mL): Peak concentration."|3 years|All-Subjects-Pharmacokinetically-Evaluable consisted of 103 subjects.Subjects excluded from PK evaluation due to age, use of by protocol prohibited steroidal medication during trial and contraceptives within one week prior to Implanon insertion and their pre-insertion ENG concentration was not proven to be below Lower Limit Of Quantification (LLOQ)|||pg/mL||Full Range|Mean
1235096|NCT00620464|Primary|Bioequivalence of Implanon® and Radiopaque Implanon.|"Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25.~AUC0-6months (Area under the curve from zero to six months).~AUC0-24months (Area under the curve from zero to 24 months).~AUC0-36months (Area under the curve from zero to 36 months)."|3 years|103 subjects were pharmacokinetically evaluable. Subjects were excluded from PK evaluation for use of protocol-prohibited steroidal medication during the trial or contraceptives within 1 week prior to Implanon insertion, or because their pre-insertion ENG concentration was not proven to be below the Lower Limit of Quantification (LLOQ)|||pg•month/mL||Full Range|Mean
1235097|NCT00620425|Primary|The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).|Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.|-15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose||||injections|Participants||Number
1235098|NCT00620373|Secondary|Recall Rate|Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).|||percentage of participants||95% Confidence Interval|Number
1235099|NCT00620373|Secondary|Specificity|Specificity measures the proportion of negatives which are correctly identified as such.|12 month after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging). The number of participants negative for breast cancer was 936-11 = 925.|||number of true negatives|||Number
1235100|NCT00620373|Primary|Number of Participants With Cancer Diagnosis at 12 Months||12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).|||participants|||Number
1235101|NCT00620373|Secondary|Sensitivity|Sensitivity measures the proportion of actual positives which are correctly identified as such.|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).|||number of cancers diagnosed|||Number
1235102|NCT00620373|Primary|Diagnostic Yield|Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).|||cancers per 1000 women screened||95% Confidence Interval|Number
1235103|NCT00620282|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 0-12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.|||episodes|||Number
1235104|NCT00620282|Secondary|Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range|Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).|week 0, week 12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.|||participants|||Number
1235105|NCT00620282|Secondary|Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range|Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).|week 0, week 12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.|||participants|||Number
1235106|NCT00620282|Secondary|Biomarkers of Cardiovascular Risk - Change in TNF-alpha|Change in TNF-alpha|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||pg/mL||Standard Error|Least Squares Mean
1235107|NCT00620282|Secondary|Fasting Lipid Profile - Change in Triglycerides (TG)|Change in TG|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
1235108|NCT00620282|Secondary|Fasting Lipid Profile - Change in HDL-C|Change in HDL-C|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
1235109|NCT00620282|Secondary|Fasting Lipid Profile - Change in LDL-C|Change in LDL-C|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
1235110|NCT00620282|Secondary|Fasting Lipid Profile - Change in Total Cholesterol (TC)|Change in TC|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
1235111|NCT00620282|Secondary|Change in Body Weight||week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||kg||Standard Error|Least Squares Mean
1235112|NCT00620282|Secondary|Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles|The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
1235113|NCT00620282|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in FPG|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
1235114|NCT00620282|Secondary|Change in HbA1c (Glycosylated Haemoglobin A1c)|Percentage point change in HbA1c|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
1235115|NCT00620282|Secondary|Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)|Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mL/100 mL/min||Standard Error|Least Squares Mean
1235116|NCT00620282|Primary|Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)|Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mL/100 mL/min||Standard Error|Least Squares Mean
1235117|NCT00620126|Primary|Percentage of Participants Adherent to Therapy|Adherence was assessed using the Morisky Medication Adherence Score, a 4 item survey in which participants self-report medication-taking behavior. Each question that is answered with a No receives a score of 1. The possible scoring range is therefore 0 to 4. Higher scores correlate with better medical adherence. For the purpose of evaluating percent of participants adherent to therapy, the variable was dichotomized to “Adherent” or “Non-adherent”. Any response of Yes to one of the 4 items was scored as “Non-Adherent”.|12 Months||||Percentage of Participants|||Number
1235118|NCT00620126|Primary|Quality of Life (IBDQ)|Disease-specific quality of life was assessed using the IBD questionnaire (IBDQ). Scores for the IBDQ range from 32 to 224 with higher scores being associated with better quality of life. Score changes of 16 have been found to be significant changes when compared to baseline values.|12 Months||||Units||Standard Deviation|Mean
1235119|NCT00620126|Primary|Clinical Disease Activity (Seo Index)|Clinical disease activity was assessed using the Seo index. An activity index <120 represents clinical remission, whereas scores of 121-150, 151-220, and >221 correlate with mild, moderate, and severe disease respectively. The Seo index is sensitive to change, with a decrease in the index of 35 correlating with a clinical response.|12 months||||Units||Standard Deviation|Mean
1235120|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level|s-P1NP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s- P1NP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-P1NP data.|||percent change||95% Confidence Interval|Least Squares Mean
1235121|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level|s-BSAP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s-BSAP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-BSAP data.|||percent change||95% Confidence Interval|Least Squares Mean
1235122|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre)|The u-DPD/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-DPD/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available u-DPD/Cre data.|||percent change||95% Confidence Interval|Least Squares Mean
1235123|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level|s-CTx is a biochemical marker index of bone resorption. Blood samples were collected in the morning and in fasting state for measurement of s-CTx. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-CTx data.|||percent change||95% Confidence Interval|Least Squares Mean
1235124|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio|The u-NTx/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-NTx/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] – [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|Per Protocol (PP) Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available u-NTx/Cre data.|||percent change||95% Confidence Interval|Least Squares Mean
1235125|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Trochanter BMD|BMD (g/cm2) data was measured by DXA at the trochanter subregion of the hip (near bony protrusions along outside edge of femur) at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] – [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment trochanter BMD measurements, with data carried forward.|||percent change||95% Confidence Interval|Least Squares Mean
1235126|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Femoral Neck BMD|BMD (g/cm2) data was measured by DXA at the femoral neck subregion of the hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] – [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment femoral neck BMD measurements, with data carried forward.|||percent change||95% Confidence Interval|Least Squares Mean
1235127|NCT00620113|Primary|Number of Participants That Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR’s products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm. Participants may have discontinued study drug but continued on the trial.|From first dose up to end of treatment (up to 52 weeks)|Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.|||participants|||Number
1235151|NCT00619957|Secondary|Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||millimeters||95% Confidence Interval|Least Squares Mean
1235152|NCT00619957|Secondary|Change From Baseline in Body Height, Month 24, ITT Population.||Baseline to Month 24|ITT Population|||millimeters||95% Confidence Interval|Least Squares Mean
1235128|NCT00620113|Primary|Number of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR’s products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.|From first dose up to Post-Study (up to 54 weeks)|Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.|||participants|||Number
1235129|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Total Hip BMD|BMD (g/cm2) data was measured by DXA for total hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] – [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment total hip BMD measurements, with data carried forward.|||percent change||95% Confidence Interval|Least Squares Mean
1235130|NCT00620113|Primary|Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)|BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] – [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|Full Analysis Set (FAS): All randomized participants receiving at least one dose of study medication and with necessary on-treatment lumbar spine BMD measurements, with data carried forward.|||percent change||95% Confidence Interval|Least Squares Mean
1235131|NCT00620074|Secondary|Voriconazole Trough Levels With Intravenous and Oral Dosing|Voriconazole trough plasma concentrations measured as nanograms per milliliter (ng/mL).|Week 1 through Week 6|ITT; only 1 pharmacokinetic sample was collected for each subject, therefore a comprehensive analysis of trough plasma concentrations was not completed due to insufficient data.|||ng/mL||Standard Deviation|Mean
1235132|NCT00620074|Secondary|Galactomannan Titer Assay Levels and Global Response|Number of subjects per Galactomannan titer level with global response for all subjects (with or without renal impairment). The galactomann assay is an immunological blood serum test used to diagnose invasive aspergillosis and to monitor disease progression. Global response is a composite of clinical and radiological findings summarized as Complete Response: resolution of all clinical signs and symptoms; Partial Response: clinical improvement; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|Up to Week 6|ITT. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.|||participants|||Number
1235133|NCT00620074|Secondary|Summary of Mortality|Number of subects with documented mortality (death).|Up to Week 6|ITT|||participants|||Number
1235134|NCT00620074|Secondary|Summary of Global Response at Week 2, Week 4, and Week 6|Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|Week 2, Week 4, Week 6|ITT; due to low study enrollment, data not summarized by global response at Week 2, Week 4, and Week 6. Cross-reference outcome measure: Summary of Global Response at End of Treatment (EOT).|||participants|||Number
1235135|NCT00620074|Primary|Summary of Global Response at End of Treatment (EOT)|Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|End of Treatment (Day 42)|Intent-to-treat (ITT): includes all subjects who received at least 1 dose of study medication. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.|||participants|||Number
1235136|NCT00620035|Primary|Implant Removal Time (Seconds)|The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced.|Day 1|All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals.|||Seconds||Standard Deviation|Mean
1235137|NCT00620035|Primary|Implant Insertion Time (Seconds)|The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced.|Day 1|All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions.|||Seconds||Standard Deviation|Mean
1235153|NCT00619957|Secondary|Change From Baseline in Body Height, Month 12, ITT Population.||Baseline to Month 12|ITT Population|||millimeters||95% Confidence Interval|Least Squares Mean
1235138|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
1235139|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
1235140|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator & the implant. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
1235141|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
1235142|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects|In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
1235143|NCT00620022|Secondary|Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose|At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|End of each 3 week treatment period (last day of Weeks 3 and 9)|Modified-intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.|||Liters||Standard Error|Least Squares Mean
1235144|NCT00620022|Primary|Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period|At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.|End of each 3 week treatment period (last day of Weeks 3 and 9)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.|||Seconds||Standard Error|Least Squares Mean
1235145|NCT00619983|Primary|Visual Analog Scale for Pain|"The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as No pain at all and on the right as The worst pain imaginable. The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone)."|Study completion (16 weeks)|As noted in patient flow, data are available for only 14 of 22 subjects due to failure of the electronic daily diaries used to assess pain during the study and to study discontinuation in some cases|||units on a scale||Full Range|Median
1235146|NCT00619970|Primary|Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment||baseline (week 0) and at 2 weeks post treatment|1 patient from the treatment group withdrew from the study. Four additional children, 2 from the treatment group and 2 from the placebo group, did not show up for their follow up breath test|||Participants|||Count of Participants
1235147|NCT00619970|Primary|The Number of Participants at Baseline With SIBO||upon enrollment||||Participants|||Count of Participants
1235148|NCT00619957|Secondary|Cumulative Incidence of Fractures, 24 Months, ITT Population|Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years|Baseline to Month 24|ITT Population|||Fractures / 100 patients / 2 years|||Number
1235149|NCT00619957|Secondary|Cumulative Incidence of Fractures, 12 Months, ITT Population|Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year|Baseline to Month 12|ITT Population|||Fractures / 100 patients / year|||Number
1235150|NCT00619957|Secondary|Percent of Responders Lumbar Spine BMD, Month 24, ITT Population|responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24|Baseline to Month 24|ITT Population|||Percentage of Participants|||Number
1235169|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
1235170|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235171|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235172|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235173|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
1235174|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235175|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235176|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235177|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
1235178|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235179|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235180|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235181|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235182|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235183|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1235226|NCT00619801|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 3 (Day 7)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|7 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1236820|NCT00608491|Secondary|Change in Blood Hemoglobin Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||g/dL||Standard Deviation|Mean
1235184|NCT00619957|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
1235185|NCT00619918|Secondary|Supplemental Medication Use||14 days|||||||
1235186|NCT00619918|Secondary|IV Fluid Use||14 days|||||||
1235187|NCT00619918|Secondary|Hours of Oxygen Use||14 days|||||||
1235188|NCT00619918|Primary|Change in RDAI Score||1 day|||||||
1235189|NCT00619918|Primary|Length of Stay|Length of stay defined as date of discharge minute date of admission.|1 month||||Days||Standard Deviation|Mean
1235190|NCT00619918|Primary|Admission Rate|Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.|1 day||||participants|||Number
1235191|NCT00619892|Secondary|Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).|Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM‑A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.|Comparing baseline and the end of 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
1235192|NCT00619892|Primary|Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores|Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.|Baseline and the end of 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
1235193|NCT00619866|Secondary|Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24|Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and Week 24|All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 24.|||percent change||Standard Deviation|Mean
1235194|NCT00619866|Secondary|Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12|Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and week 12|All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 12.|||percent change||Standard Deviation|Mean
1235195|NCT00619866|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24|Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and Week 24|All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 24.|||percent change||Standard Deviation|Mean
1235196|NCT00619866|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12|Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and week 12|All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 12.|||percent change||Standard Deviation|Mean
1235197|NCT00619866|Secondary|Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image with five response categories for each item (Never, Rarely, Sometimes, Often, Always)~A supplemental questionnaire consisting of six additional questions which assess the areas of work, relationship with children, sexual intercourse, feelings about the medical profession, treatment, and infertility with the same five response categories plus an additional response category of Not Relevant which was not scored.~The scores associated with each possible outcome category are as follows: never (0), rarely (25), sometimes (50), often (75), and always (100). A negative change from baseline score indicates improvement in quality of life."|Baseline and week 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
1235198|NCT00619866|Secondary|Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
1235199|NCT00619866|Secondary|Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
1235200|NCT00619866|Secondary|Patient Global Impression of Change at Weeks 4, 8 and 12|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
1235201|NCT00619866|Secondary|Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. To assess dyspareunia (painful intercourse) participants were asked to select the best description of pain during sexual intercourse over the past 28 days using the following response categories:~0 = Absent; No discomfort during sexual intercourse.~1 = Mild; I can tolerate the discomfort during sexual intercourse.~2 = Moderate; Intercourse is sometime interrupted due to pain.~3 = Severe; I prefer to avoid intercourse because of pain.~Not applicable. I am not sexually active for reasons other than my endometriosis symptoms."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1235202|NCT00619866|Secondary|Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
1235203|NCT00619866|Secondary|Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
1235204|NCT00619866|Secondary|Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
1235205|NCT00619866|Secondary|Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
1235206|NCT00619866|Secondary|Change From Baseline in the Percentage of Days of Narcotic Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of “none”)."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
1235207|NCT00619866|Secondary|Change From Baseline in the Percentage of Days of Prescription Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of “none”)."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
1235208|NCT00619866|Secondary|Change From Baseline in the Percentage of Days of Any Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of “none”)."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
1235209|NCT00619866|Secondary|Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment|"Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day in an e-Diary on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain.~The percentage of days a participant reported a value of zero (no pain) for the non-menstrual pelvic pain and dysmenorrhea total score was calculated for the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
1235210|NCT00619866|Secondary|Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options:~Subject is not having her period~0 = No pain related to period~1 = Mild pain related to period; subject could not do some of the things she usually does~2 = Moderate pain related to period; subject could not do many of the things she usually does~= Severe pain related to period; subject could not do most of or all of the things she usually does.~The percentage of days a participant reported a value of zero (no pain) for dysmenorrhea was calculated for the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
1235211|NCT00619866|Secondary|Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:~0 = No pelvic pain~1 = Mild pelvic pain; subject could not do some of the things she usually does~2 = Moderate pelvic pain; subject could not do many of the things she usually does~3 = Severe pelvic pain; subject could not do most or all of the things she usually does.~The percentage of days a participant reported a value of zero (no pain) for non-menstrual pelvic pain was calculated for the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
1235212|NCT00619866|Secondary|Percentage of Days With No Pain Based on NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The percentage of days a participant reported a value of zero (or “no pain”) for the NRS was calculated for the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
1235213|NCT00619866|Secondary|Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores|"Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in an e-Diary.~The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1235227|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1235228|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1235214|NCT00619866|Secondary|Change From Baseline in the Monthly Mean Dysmenorrhea Score|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options:~Subject is not having her period~0 = No pain related to period~1 = Mild pain related to period; subject could not do some of the things she usually does~2 = Moderate pain related to period; subject could not do many of the things she usually does~3 = Severe pain related to period; subject could not do most of or all of the things she usually does.~The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1235215|NCT00619866|Secondary|Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:~0 = No pelvic pain~1 = Mild pelvic pain; subject could not do some of the things she usually does~2 = Moderate pelvic pain; subject could not do many of the things she usually does~3 = Severe pelvic pain; subject could not do most or all of the things she usually does.~The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1235216|NCT00619866|Secondary|Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1235217|NCT00619866|Secondary|Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4 and 8|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1235218|NCT00619866|Primary|Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and week 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1235219|NCT00619827|Primary|Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours|The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (]0-4] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS ]0-4] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.|4 months|The Intent-to-treat (ITT) population included all randomised subjects who received at least one dose of the investigational product.|||Units on a scale (range: 0 to 18)||Standard Error|Mean
1235220|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||micromole per liter [µmol/L]||Full Range|Median
1235221|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||millimole per liter [mmol/L]||Full Range|Median
1235222|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||unit per liter [U/L]||Full Range|Median
1235223|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||unit per liter [U/L]||Full Range|Median
1235224|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||micromole per liter [µmol/L]||Full Range|Median
1235229|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration|The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1235230|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval|The PR interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1235231|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval|The RR interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
1235232|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
1235233|NCT00619762|Primary|Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix|Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response & revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization & immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed & if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of “sparse or light” distribution & 3 HP fields of dense distribution counted & results averaged. Tissue sample then assessed for overall acellularity & expressed as %.|At the time of expander/implant exchange (Stage II),|All implanted patients enrolled in the study were included in the analysis|||percentage of breasts|Participants||Number
1235234|NCT00619762|Secondary|Severity of Local Inflammation at and Around the Surgical Site|The Inflammatory response was evaluated by each of the four cardinal signs: erythema, edema, pain and heat, using standard scales for the evaluation of each sign and inflammation as a whole was assessed using a model (AIR Score) which took into account the scores assigned to each of the four signs. A mean score is provided at each timepoint.The minimum total possible score is 4 (less inflamation) and the maximum total possible score is 8 (more inflammation).|Postoperative Day 7, 14, 21, 30 days|Total breasts enrolled were 29. Day 7, N = 28 breasts available Day 14, N = 27 breasts available Day 21, N = 27 breasts available Day 30, N = 25 breasts available|||units on a scale|Participants|Standard Deviation|Mean
1235235|NCT00619723|Secondary|Manic Symptoms Measured Using Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) is a clinician-rated scale that has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. The total score is calculated by summing answers to all the item on the scale, with a higher score indicative of more severe mania symptoms. The scale total score ranges from 0 (absence of manic symptoms) to 60 (severe manic symptoms).|12 weeks||||units on a scale||Standard Deviation|Mean
1235236|NCT00619723|Secondary|Depressive Symptoms Measured Using the Hamilton Rating Scale for Depression (HRSD)|As part of HRSD, the patient is rated by a clinician on 17 items that measure depressive symptom severity. The total score is calculated by summing the responses across all items. Lower scores (closer to 0) indicate the absence of depressive symptoms, while higher scores indicate the presence of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2 (0 = not present; 2 = severe). The scale range of scores is 0-52.|12 Weeks||||units on a scale||Standard Deviation|Mean
1235237|NCT00619723|Primary|Percentage of Participants With Presence of a Cocaine-Positive Urine Screen|Cocaine use frequency was measured by the presence or absence of a cocaine-positive urine screen. Drug screens were obtained thrice-weekly for 12 weeks. All participants who completed the baseline assessment and at least one additional assessment were included in the primary analysis. Missing data were imputed as cocaine positive.|12 weeks||||percentage of participants|||Number
1235238|NCT00619684|Secondary|Overall Survival|Kaplan-Meier estimate of survival|At 1 and 2 years after starting treatment with lenalidomide|Patients enrolled on trial who received lenalidomide therapy.|||percentage of participants||95% Confidence Interval|Number
1235239|NCT00619684|Secondary|TTP|"Time to Progression (TTP): Time from start of therapy to meeting the definition of Progressive Disease (PD).~PD: 25% increase compared to the lowest value of:~Serum MP (absolute increase at least ≥ 0.5 g/dl)~Or: Urine MP (absolute increase at least > 200 mg/24h)~Or: for patients without measurable MP, Serum Free Light Chain test: the difference between involved and uninvolved FLC levels (absolute increase at least >100 mg/L)"|Up to 9 years|Patients who developed Progressive Disease while on lenalidomide treatment|||Months||Full Range|Median
1235240|NCT00619684|Secondary|Number of Patients Who Experience Improvement in GVHD on Lenalidomide, Defined as the Reduction in Severity of GVHD as Defined by the National Institutes of Health (NIH) Consensus Criteria||Up to 9 years|Patients who received lenalidomide on study|||Participants|||Count of Participants
1235241|NCT00619684|Secondary|Number of Patients Requiring Dose Interruption, Dose Reduction or Discontinuance of Lenalidomide|Dose interruption, dose reduction or discontinuation of lenalidomide due to toxicity, GVHD or disease progression|Up to 9 years|Patients enrolled on the trial who received lenalidomide treatment.|||Participants|||Count of Participants
1235242|NCT00619684|Secondary|Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Grade 1-2 adverse events occurring in >10% of participants. Grade 3 or higher adverse events occurring in one or more participants.|Up to 30 days after completion of study treatment||||percentage of participants|||Number
1235316|NCT00619190|Secondary|Clinical Global Impressions Scale - Severity Score (CGI-S)|"One of the most widely used of clinician assessment tools in psychiatry, the CGI is an observer-rated scale that measures illness severity (CGI-S).~The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients)."|Baseline to 12 weeks|Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.|||units on a scale||Standard Deviation|Mean
1235243|NCT00619684|Primary|Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR)|"CR: No Monoclonal Protein (MP) in the blood AND no serum/urine MP by Immunofixation (IF < 0) AND < 5% plasma cells in bone marrow aspirate.~VGPR: More than 90% decrease of MP and urine M protein < 100 mg/d OR serum protein electrophoresis (SPEP)/urine protein electrophoresis(UPEP) negative but serum immunofixation (IFs) or IFu urine immunofixation (IFu) ) still positive.~PR: Over 50% decrease of serum MP AND > 90% reduction in 24h urinary light chain excretion or M proteinuria < 200mg/d MR: Between 25 and 49% decrease of MP in the blood AND 50-89% reduction in 24h urinary light chain excretion (monoclonal proteinuria>200 mg/d)"|Up to 9 years||||Participants|||Count of Participants
1235244|NCT00619645|Secondary|Number of Patients Alive 24 Months Post Day 100 Transplant|Patients will be followed for survival for 24 months post day 100 transplant.|24 months post day 100 transplant||||Participants|||Count of Participants
1235245|NCT00619645|Secondary|Number of Patients Without Progression After Day 100 Transplant|All patients will be followed for progression for 24 months after their day 100 transplant.|24 months after day 100 transplant|This outcome was not collected/analyzed||||||
1235246|NCT00619645|Primary|Number of Patients With Day 100 Transplant-related Mortality|Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.|24 months after day 100 transplant||||Participants|||Count of Participants
1235247|NCT00619619|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT; no participants had a CGI-I score of 6 or 7, therefore only scores 1 through 5 are reported.|||percentage of participants|||Number
1235248|NCT00619619|Secondary|Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method|Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].|Day 1, Day 28, and Day 56|PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.|||(ng*hr/mL)/mg of dose|||Number
1235249|NCT00619619|Secondary|Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method|Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].|Day 1, Day 28, and Day 56|PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.|||(ng*hr/mL)/mg of dose|||Number
1235250|NCT00619619|Primary|Area Under the Curve From Time Zero to Infinity (AUC0-∞)|AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population|||ng*hr/mL||Standard Deviation|Mean
1235251|NCT00619619|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population|||hr||Standard Deviation|Mean
1235252|NCT00619619|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population|||hr||Standard Deviation|Mean
1235253|NCT00619619|Primary|Maximum Observed Plasma Concentration (Cmax)|Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population: all participants in the Safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.|||ng/mL||Standard Deviation|Mean
1235254|NCT00619619|Primary|Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.|Baseline to Follow-up (up to Day 77)|Safety population includes all treatment-assigned participants who have taken at least 1 dose of study treatment.|||participants|||Number
1235359|NCT00618813|Secondary|Event Free Survival|Disease progression, occurrence of a second malignant neoplasm (SMN)or death will be considered an analytic event. In all other cases, the patient will be considered censored at last contact.|From enrollment to event or 10 years from enrollment, whichever occurs first|||||||
1235255|NCT00619619|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT; no participants had a CGI-S score of 6 or 7, therefore only scores 1 through 5 are reported.|||percentage of participants|||Number
1235256|NCT00619619|Other Pre-specified|Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score|HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT|||Score on a scale||Standard Deviation|Mean
1235257|NCT00619619|Other Pre-specified|Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT: all treatment-assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after the first dose of study treatment.|||scores on a scale||Standard Deviation|Mean
1235258|NCT00619502|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|"Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable."|Day 0 up to Day 7 post-booster vaccination|Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP~T according to the primary series received (Safety Analysis Population).|||Participants|||Number
1235259|NCT00619502|Primary|Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).|Day 0 before and Day 30 post-booster vaccination|GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1235260|NCT00619502|Primary|Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™|Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.|Day 0 before and Day 30 Post-booster vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.|||Percentage of Participants|||Number
1235261|NCT00619489|Secondary|Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay|The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal address in cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay at time points where at least 50% of participants in the analysis set had non-missing results. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.|Days 43, 99, 155 and 267, predose|Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.|||percent MADCAM binding||Standard Deviation|Mean
1235262|NCT00619489|Secondary|Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay|The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the ACT-1 binding interference assay. ACT-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.|Days 43, 99, 155 and 267, predose|Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.|||% ACT1 binding||Standard Deviation|Mean
1235317|NCT00619177|Secondary|Physician Assessment of Efficacy|"Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.~The patients have been placed into categories according to the points on a scale."|after approximately 4 weeks of treatment|Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on physician assessment of efficacy.|||Participants|||Number
1235263|NCT00619489|Secondary|Serum Concentration of Vedolizumab Before Dosing|Vedolizumab serum concentrations were measured from serum samples collected for pharmacokinetic (PK) analysis within 2 hours prior to dosing. The original protocol specified that PK parameters, including but not limited to minimum plasma concentration (Cmin), were to be estimated; however, due to intrapatient dose modification with Amendment 1, it was no longer feasible to perform a full PK parameter estimation. The summaries of pre-infusion data (i.e., trough levels) are presented at time points where at least 50% of participants had quantifiable vedolizumab concentrations, using a value of 0 for results below a measurable range. This provides information on the pharmacokinetic behavior of vedolizumab when administered as long-term therapy.|Days 43, 99, 155 and 267, predose|"The PK Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PK parameters. Participants without dose modification and with available serum concentration data at each time point (indicated by n) are included."|||μg/mL||Standard Deviation|Mean
1235264|NCT00619489|Primary|Number of Participants With Human Anti-human Antibodies (HAHA)||Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.|Safety analysis set|||participants|||Number
1235265|NCT00619489|Primary|Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML)|At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist.|through Day 637|Safety analysis set|||participants|||Number
1235266|NCT00619489|Primary|Number of Participants With Clinically Significant Laboratory Findings|Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood.|through Day 637|Safety analysis set|||participants|||Number
1235267|NCT00619489|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity.~The intensity for each AE was defined according to the following criteria:~Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities."|From Day 1 to Day 637|Safety analysis set, defined as all enrolled participants who received at least 1 dose of study drug. Analysis was based on the lowest dose received, rather than dose at randomization.|||participants|||Number
1235268|NCT00619476|Secondary|Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The CGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.|||participants|||Number
1235269|NCT00619476|Secondary|Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data|The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||points on a scale||Standard Error|Least Squares Mean
1235270|NCT00619476|Secondary|Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data|The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||points on a scale||Standard Error|Least Squares Mean
1235271|NCT00619476|Secondary|Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data|The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||points on a scale||Standard Error|Least Squares Mean
1235318|NCT00619177|Secondary|Patient Assessment of Efficacy|"Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.~The patients have been placed into categories according to the points on a scale."|after approximately 4 weeks of treatment|Full analysis set (FAS). This analysis was performed on all patients in FAS with available data on the global assessment of general efficacy.|||Participants|||Number
1235272|NCT00619476|Secondary|Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (Week 13 or early withdrawal)|ITT Population. There was one participant in the GEn 1200 mg and two in the GEn 2400 mg group who did not have enough data available to calculate the rescue mediation consumed while on treatment.|||milligrams||Standard Error|Least Squares Mean
1235273|NCT00619476|Secondary|Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score|Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as the first day of event minus the last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.|Anytime post-baseline until date of last dose of study medication (up to Week 13)|ITT Population|||days||Full Range|Median
1235274|NCT00619476|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data|Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg and one in the GEn 2400 mg group who did not have enough data available to calculate the percent reduction.|||participants|||Number
1235275|NCT00619476|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The PGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.|||participants|||Number
1235276|NCT00619476|Secondary|Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data|Dynamic allodynia (pain in response to a standardized light touch stimulus, a foam brush applied with light pressure to the site of maximum pain) was assessed by an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The NRS analysis included a subset of the ITT Population who completed that NRS at both the Baseline and the Week13/Withdrawal Visit.|||points on a scale||Standard Error|Least Squares Mean
1235277|NCT00619476|Secondary|Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data|The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The SF-MPQ analysis included a subset of the ITT Population who completed a SF-MPQ assessment at both Baseline and the Week 13/Withdrawal Visit.|||points on a scale||Standard Error|Least Squares Mean
1235278|NCT00619476|Secondary|Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data|The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The NPS summary included a subset of the ITT Population that completed an NPS assessment at both Baseline and Week 13/Withdrawal.|||points on a scale||Standard Error|Least Squares Mean
1235279|NCT00619476|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data|Day-time worst pain is defined as the participant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1220 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EOMT timepoint.|||points on a scale||Standard Error|Least Squares Mean
1235357|NCT00618826|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|maximum 50 months|patients with measurable disease|||proportion of participants||95% Confidence Interval|Number
1235280|NCT00619476|Secondary|Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EMOT timepoint.|||points on a scale||Standard Error|Least Squares Mean
1235281|NCT00619476|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate an API for the EOMT timepoint.|||points on a scale||Standard Error|Least Squares Mean
1235282|NCT00619476|Secondary|Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate a score for the EMOT timepoint.|||points on a scale||Standard Error|Least Squares Mean
1235283|NCT00619476|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data|Night-time worst pain is defined as the participant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.|||points on a scale||Standard Error|Least Squares Mean
1235284|NCT00619476|Secondary|Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.|||points on a scale||Standard Error|Least Squares Mean
1235285|NCT00619476|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline wss calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EOMT timepoint.|||points on a scale||Standard Error|Least Squares Mean
1235286|NCT00619476|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data|Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as EOMT score minus Baseline score.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population: all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement.|||points on a scale||Standard Error|Least Squares Mean
1235287|NCT00619385|Primary|AUC Post Final Dose||7 days||||hour*ng/mL||Standard Deviation|Mean
1235288|NCT00619385|Primary|Cmax Post Final Dose|To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.|7 days||||ng/mL||Standard Deviation|Mean
1235289|NCT00619359|Secondary|No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)|The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.|Overall (the 120 hours following initiation of cisplatin chemotherapy)|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 2 patients (aprepitant group) had no vomiting data, and were excluded from this analysis.|||Participants|||Number
1235290|NCT00619359|Secondary|A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).|The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.|Delayed phase (25 to 120 hours following initiation of cisplatin).|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 1 patient (aprepitant group) had no delayed phase data, and was not included in this analysis.|||Participants|||Number
1235291|NCT00619359|Primary|A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).|The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.|Overall (in the 120 hours following initiation of cisplatin chemotherapy).|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment.|||Participants|||Number
1235292|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score|This is defined as the sum of the scores for “side effects” section questions 9 to 11, corresponding to minimum possible total score of 3 and a maximum possible total score of 15. The lower the score, the better the outcome.|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
1235293|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score|This is defined as the sum of the scores for the “side effects” section questions 5 to 8, with a minimum possible total score of 1 and a maximum possible total score of 20. The lower the score, the better the outcome.|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
1235294|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score|This is defined as the sum of the scores for the “injection systems” section questions 1-9, with a minimum possible total score of 9 and a maximum possible total score of 45. The lower the score, the better the outcome.|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
1235295|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score|This is defined as the sum of the scores for the “injection systems” section questions 1-9 and the “side effects” section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. The lower the score, the better the outcome.|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
1235296|NCT00619307|Primary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score|This is defined as the sum of the scores for the “side effects” section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome.|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
1235297|NCT00619255|Secondary|Number of Patients Experiencing High-Level Depressive Symptoms|The investigators used the Patient Health Questionnaire (PHQ-9) to identify symptoms consistent with a diagnosis of depression on the 9-item Patient Health Questionnaire depression screen. Scores range from 1 to 27 with higher scores representing worse outcomes.|Baseline (injury), then 2, 5, and 12 months post-injury||||Participants|||Count of Participants
1235298|NCT00619255|Secondary|Percentage of Adolescents Who Self-reported Weapon Carriage|Self-reported carrying of knife, gun, club or other weapon by adolescent|Baseline (injury), then 2, 5, and 12 months post-injury||||Participants|||Count of Participants
1235299|NCT00619255|Secondary|Percentage of Asolescents Linked to Primary Care During the Study|Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury|Up to12 months post-injury||||Participants|||Count of Participants
1235300|NCT00619255|Secondary|Number of Patients Who Self-reported Alcohol Consumption or Drug Use|Any self-reported alcohol or drug use using one yes or no question|Baseline (injury), and 2, 5, and 12 months post-injury||||Participants|||Count of Participants
1235301|NCT00619255|Primary|Number of Patients With High Levels of Adolescent PTSD Symptoms|Patients with symptoms consistent with a diagnosis of PTSD on the UCLA PTSD Reaction Index were counted. The UCLA PTSD-RI can be used to create an algorithm consistent with a diagnosis of PTSD by rating 1 intrusive, 3 avoidant, and 2 arousal symptoms with a rating of moderate severity. The PTSD–RI is scored on a scale from 0 (none of the time) - 4 (most of the time) with a > = 2 “some of the time” denoting this cutoff for moderate severity. This algorithm was used to identify patients with high PTSD symptom levels consistent with a diagnosis of PTSD.|Baseline (injury), then 2, 5, and 12 months post-injury||||Participants|||Count of Participants
1235302|NCT00619242|Primary|Ki-67|Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett’s esophagus.|Two weeks|The 3 subjects underwent therapy without complications however the study was terminated due to low accrual.||||||
1235303|NCT00619229|Secondary|The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to 6 months|Full Analysis Set (FAS)|||Participants|||Number
1235304|NCT00619229|Secondary|The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to 3 months|Full Analysis Set (FAS)|||Participants|||Number
1235305|NCT00619229|Secondary|The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to time immediately after intervention|Full Analysis Set (FAS)|||Participants|||Number
1235358|NCT00618826|Primary|Progression-free Survival|Time from study entry to disease progression or death|maximum 50 months||||months||95% Confidence Interval|Median
1235306|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to 6 months|Full Analysis Set (FAS)|||Unit on a scale||Standard Deviation|Mean
1235307|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to 3 months|Full Analysis Set (FAS)|||Unit on a scale||Standard Deviation|Mean
1235308|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to time immediately after intervention|Full Analysis Set (FAS)|||Unit on a scale||Standard Deviation|Mean
1235309|NCT00619229|Secondary|Development of a Wet Age-related Macular Degeneration|"A wet age-related macular degeneration (AMD) is defined as the development of choroidal neovascularization of the study-eye (worse eye).~Development is categorized in Yes and No, where Yes means that a subject who had no wet AMD at Screening has developed a wet AMD at Week 29."|From baseline to 6 months|Full Analysis Set (FAS)|||Participants|||Number
1235310|NCT00619229|Secondary|Progression of the Dry Age-related Macular Degeneration|"Severity of the diagnosed dry age-related macular degeneration (AMD) was assessed in comparison to Baseline and classified as~Progression~Stabilization~Amelioration"|From baseline to 6 months|Full Analysis Set (FAS)|||Participants|||Number
1235311|NCT00619229|Secondary|The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to 6 months|Full Analysis Set (FAS)|||Lines read in ETDRS chart||Standard Deviation|Mean
1235312|NCT00619229|Secondary|The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to time immediately after intervention|Full Analysis Set (FAS)|||Lines read in ETDRS chart||Standard Deviation|Mean
1235313|NCT00619229|Primary|Difference in Visual Acuity Between Measurements at 3 Months After Drug Intervention and Measurements at Baseline (Assessed Within Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to 3 months|Full Analysis Set (FAS)|||Lines read in ETDRS chart||Standard Deviation|Mean
1235314|NCT00619190|Secondary|Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks|The Aberrant Behavior Checklist lethargy/social withdrawal subscale (ABC-SW) is the sum of ratings from 0 - not a problem at all to 3 - problem is severe in degree on 16 items within the Aberrant Behavior checklist (also described in the primary outcome measure section above). Scores can range from 0 to 48, with higher scores indicating more severe problems. The period for the rating is one week and the reference group is typically developing children of the same age and gender as the participant. Both frequency of the behaviors and severity of the problems related to them are considered. High ratings on these items reflect lack of response and interaction with other people in the child's environment.|Baseline to 12 weeks|Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.|||units on a scale||Standard Deviation|Mean
1235315|NCT00619190|Primary|Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks|The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant.|Baseline to 12 weeks|Only 20 out of 21 total participants were analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.|||units on a scale||Standard Deviation|Mean
1235319|NCT00619177|Secondary|Change From Baseline of Pain Intensity on Visual Analogue Scale|The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain)|Approximately four weeks of treatment|Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on pain intensity on VAS at baseline and final visit.|||Units on a scale||Standard Deviation|Mean
1235320|NCT00619177|Primary|Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2|Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)|Baseline and final visit (approximately 4 weeks)|A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).|||Units on a scale||Standard Deviation|Mean
1235321|NCT00619177|Primary|Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.|Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)|baseline and final visit (approximately 4 weeks)|A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).|||Units on a scale||Standard Deviation|Mean
1235322|NCT00619151|Primary|Aortic Mean Gradient|Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.|6 months|Analysis not performed due to study termination prior to analysis period.|||mmHg||Standard Deviation|Mean
1235323|NCT00619151|Primary|Effective Orifice Area (EOA)|Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.|6 month evaluation|Analysis not performed due to study termination prior to analysis period.|||cm^2||Standard Deviation|Mean
1235324|NCT00619112|Secondary|Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued||From beginning of voluntarily temozolomide discontinued up to 6 months||||Participants|||Count of Participants
1235325|NCT00619112|Secondary|Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide||Within 6 months after 6th adjuvant course of temozolomide||||Participants|||Count of Participants
1235326|NCT00619112|Secondary|Patients Progressing After Two First-line Adjuvant Courses of Temozolomide||After two first-line adjuvant courses of temozolomide||||Participants|||Count of Participants
1235327|NCT00619112|Secondary|Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System|PCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study.|prior to start of study||||Participants|||Count of Participants
1235328|NCT00619112|Secondary|Overall Survival||up to 2 years after treatment||||weeks||95% Confidence Interval|Median
1235329|NCT00619112|Secondary|Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.|Progression-free survival data (obtained for Primary Outcome Measure) was correlated with tumor MGMT (O(6)-methylguanine-DNA methyltransferase) promoter methylation status, obtained from patients as part of the study.|First day of treatment until progression or until 6 months mark|Tumor tissue was available for the exploratory MGMT methylation analysis in 48 patients. In 7 samples the tissue was inadequate for analysis.|||weeks||95% Confidence Interval|Median
1235330|NCT00619112|Primary|6 Month Progression-free Survival|Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival|First day of treatment until progression or until 6 months mark||||percentage of patients||95% Confidence Interval|Number
1235331|NCT00619099|Primary|The Overall Improvement Rate|"Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement.~Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Remission: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%.~Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%.~Marrow Complete Remission: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.~HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response."|Up to one year|Modified Intent to Treat (mITT) Population|||Percentage of Participants|||Number
1235332|NCT00619073|Primary|Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.|Value at 45 days after intervention minus value at baseline in platelet surface activated GPIIb-IIIa complex using flow cytometry.The types and concentrations of agonists used in the flow cytometry assays reported here were: ADP 0.5, 1, and 20 µmol/L; thrombin receptor activating peptide (TRAP) 1 and 20 µmol/L; and a combination of collagen 5 µg/mL and epinephrine 5 µmol/L. Mean Florescence Intensity (MFI) is used as unit of measure. MFI indicates relative degree of shift in fluorescence intensity of a population of platelets in arbitrary units.|Baseline and 45 days after intervention||||mean fluorescence intensity (MFI)||Standard Error|Mean
1235333|NCT00619060|Primary|Participants With Adverse Events by Treatment.|Comparison of number of participants with adverse events by treatment.|30 Days||||participants|||Number
1235334|NCT00618995|Secondary|Prostaglandin I Metabolite (PGI-M)|PGI-M in the Overall 24 Hour Collection Interval Following Administration on Day 7|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
1235335|NCT00618995|Primary|Urinary 11-Dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
1235336|NCT00618982|Other Pre-specified|Disease Control - mITT Population|Disease Control (DC) of a subject was defined as the proportion of patients with confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, and SD was defined as steady state of disease.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.|||Participants|||Number
1235337|NCT00618982|Other Pre-specified|Tumor Response - mITT Population|Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.|||Participants|||Number
1235338|NCT00618982|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|Intent-to treat (ITT).|||months||95% Confidence Interval|Median
1235339|NCT00618982|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|Intent-to-treat (ITT).|||months||95% Confidence Interval|Median
1235340|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Time to Maximum Concentration (Tmax)|Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had Tmax calculated; 31 participants in the 600 mg bid group that had Tmax calculated; 28 participants in the 800 mg bid group that had Tmax calculated.|||hours||Full Range|Median
1235341|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Maximum Observed Concentration in Plasma (Cmax)|Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had Cmax calculated; 31 participants in the 600 mg bid group that had Cmax calculated; 28 participants in the 800 mg bid group that had Cmax calculated.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1235342|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss)|AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 32 participants in the 400 mg bid group that had an AUC(0-12)ss calculated; 23 participants in the 600 mg bid group that had an AUC(0-12)ss calculated; 19 participants and 20 participants in the 800 mg bid group that had an AUC(0-12)ss calculated, for sorafenib and M2 parameter respectively.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1235354|NCT00618839|Primary|Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.|The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.|two weeks post-autografting|Intrapatient treatment sites were randomized such that each half of the wound site received StrataGraft and the other half received cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.|||Percent Area of Autograft Take (%)||Standard Deviation|Mean
1235355|NCT00618826|Other Pre-specified|Toxicity|toxicities recorded using CTCAE definitions|Duration of study|||||||
1235343|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss)|AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had an AUC(0-10)ss calculated; 30 participants in the 600 mg bid group that had an AUC(0-10)ss calculated; 26 participants and 27 participants in the 800 mg bid group that had an AUC(0-10)ss calculated, for sorafenib and M2 parameter respectively.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1235344|NCT00618982|Primary|Tumor Response - ITT (Intent to Treat) Population|Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the efficacy analysis was the intent-to-treat (ITT) population defined as all patients who received at least one dose of study medication with at least one valid tumor assessment post-baseline.|||participants|||Number
1235345|NCT00618982|Primary|Best Response - mITT (Modified Intent-to-treat) Population|Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.|||Participants|||Number
1235346|NCT00618956|Secondary|Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6|Change from baseline to Visit 6 in HR based on ABPM is defined as the mean HR value at Visit 6 minus the corresponding mean HR value at baseline in the same 24-hour period.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||bpm||Standard Error|Mean
1235347|NCT00618956|Secondary|Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4|Change from baseline to Visit 4 in HR based on ABPM is defined as the mean HR value at Visit 4 minus the corresponding mean HR value at baseline in the same 24-hour period.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||bpm||Standard Error|Mean
1235348|NCT00618956|Secondary|Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6|Change from baseline to Visit 6 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP value at Visit 6 minus the corresponding mean SBP/DBP value at baseline in the same 12-hour period post-AM dose.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||mm Hg||Standard Error|Mean
1235349|NCT00618956|Primary|Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6|Change from baseline to Visit 6 in mean systolic blood pressure based on ABPM is defined as the mean SBP value at Visit 6 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach|||mm Hg||Standard Error|Mean
1235350|NCT00618956|Secondary|Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4|Change from baseline to Visit 4 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP values at Visit 4 minus the corresponding mean SBP/DBP values at baseline in the same 12-hour period post-AM dose.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||mm Hg||Standard Error|Mean
1235351|NCT00618956|Primary|Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4|Change from baseline to Visit 4 in mean systolic blood pressure (SBP) based on ambulatory blood pressure monitor (ABPM) is defined as the mean SBP value at Visit 4 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||mm Hg||Standard Error|Mean
1235352|NCT00618839|Secondary|Viability of Allograft Tissues|Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells.|At the time of allograft removal (~7 days)|Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.|||Ki67 positive cells/ total cells||Full Range|Median
1235353|NCT00618839|Secondary|Appearance of Allograft Tissues|The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points).|StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.|Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.|||points||Standard Error|Mean
1235356|NCT00618826|Other Pre-specified|Overall Survival (OS) at 3 Years|proportion of participants surviving 3 years|3 years|||||||
1235360|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) – Week 29 to Week 37|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 29 to week 37|Two patients were not evaluated for DLT during weeks 29-37 because those patients did not complete that segment of protocol therapy.|||participants|||Number
1235361|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 23 to week 28|One patient was not evaluated for DLT during weeks 23-28 because the patient did not complete that segment of therapy.|||participants|||Number
1235362|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 13 to week 22|One patient was not evaluated for dose-limiting toxicity during weeks 13-22 because patient did not complete that segment of protocol therapy.|||participants|||Number
1235363|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Enrollment to week 12|Any patient who receives at least one cycle of protocol therapy, or who is removed from protocol therapy partly or solely because of a dose-limiting toxicity will be evaluable for this outcome.|||participants|||Number
1235364|NCT00618813|Primary|Incidence of Death|Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy|Length of protocol therapy (up to 37 weeks) plus 30 days|Any patient who receives at least one cycle of protocol therapy, or who dies as a result of complications of therapy prior to completing one cycle of therapy will be evaluable for this outcome|||participants|||Number
1235365|NCT00618787|Primary|Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.|At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.|Weeks 0 and 4|Per protocol|||Percentage change||Full Range|Median
1235366|NCT00618787|Secondary|Pain||5 weeks|||||||
1235367|NCT00618787|Primary|Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups||5 weeks|||||||
1235368|NCT00618774|Primary|Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG|Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.|First administration of study treatment to 24 hours post last dosing of study treatment.|Treated set|||participants|||Number
1235369|NCT00618774|Secondary|Seated Blood Pressure Normalisation at Trough|"Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months:~Optimal: SBP <120 mmHg and DBP <80 mmHg~Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg~High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg~No: SBP >=140 mmHg or DBP >=90 mmHg"|6 months and 12 months|FAS|||percentage of participants|||Number
1235370|NCT00618774|Secondary|Seated SBP Response Rate at Trough|Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months|6 months and 12 months|FAS|||percentage of participants|||Number
1235371|NCT00618774|Secondary|Seated DBP Response Rate at Trough|Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months|6 months and 12 months|FAS|||percentage of participants|||Number
1235372|NCT00618774|Secondary|Seated SBP Control Rate at Trough After 6 and 12 Months|Percentage of patients whose SBP <140 mmHg|6 months and 12 months|FAS|||percentage of participants|||Number
1235373|NCT00618774|Secondary|Seated DBP Control Rate at Trough After 6 and 12 Months|Percentage of patients whose DBP <90 mmHg.|6 months and 12 months|FAS|||percentage of participants|||Number
1235374|NCT00618774|Secondary|Change From Baseline in Seated Systolic Blood Pressure|mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure|Baseline and week 20 / week 48|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.|||mmHg||Standard Deviation|Mean
1235375|NCT00618774|Secondary|Change From Baseline in Seated Diastolic Blood Pressure|Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure|Baseline and week 20 / week 48|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.|||mmHg||Standard Deviation|Mean
1235376|NCT00618774|Secondary|Seated SBP Control Rate at Trough After 8 Weeks|Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment|Week 8|FAS|||percentage of participants|||Number
1235377|NCT00618774|Secondary|Seated DBP Control Rate at Trough After 8 Weeks|Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment|week 8|FAS|||percentage of participants|||Number
1235378|NCT00618774|Secondary|Change From Baseline in Seated Systolic Blood Pressure at Week 8|mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure|Baseline and week 8|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.|||mmHg||Standard Deviation|Mean
1235379|NCT00618774|Secondary|Change From Baseline in Seated Diastolic Blood Pressure at Week 8|mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure|Baseline and week 8|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.|||mmHg||Standard Deviation|Mean
1235380|NCT00618774|Primary|Percentage of Participants Who Experienced Adverse Events|An adverse event is defined as any untoward medical occurrence|52 weeks|Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.|||percentage of participants|||Number
1235381|NCT00618748|Secondary|Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval)|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||millisecond (msec)||Standard Deviation|Mean
1235382|NCT00618748|Secondary|Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||microgram/Liter||Standard Deviation|Mean
1235383|NCT00618748|Secondary|Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint|HbA1c is a test that measures the amount of glycated hemoglobin in the blood over prolonged periods of time.|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||percentage of glycated hemoglobin||Standard Deviation|Mean
1235384|NCT00618748|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48|EPS symptoms measured by DIEPSS are grouped into 4 categories: Parkinsonism, akathisia, dystonia, and dyskinesia. Severity ranges from level 0 (none, normal) to 4 (severe). A participant is deemed to have EPS at endpoint if they have an abnormal endpoint. Normal baseline Parkinsonism is defined as a score not ≥3 on 1 item or ≥2 on 2 items; abnormal endpoint is a score ≥3 on 1 item or ≥2 on 2 items, or an increase of 3 on Parkinsonism total. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score ≥2 or an increase ≥2 from that baseline score.|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with a normal baseline and an endpoint result. For Parkinsonism, normal baseline is defined as a score not ≥3 on 1 item or ≥2 on 2 items. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2.|||percentage of participants|||Number
1235385|NCT00618748|Secondary|Percentage of Participants With High Suicidality at Week 24 or Week 48|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit value.|||percentage of participants|||Number
1235386|NCT00618748|Secondary|Percentage of Participants With Emergence of Mania at Week 24 or Week 48|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|All Randomized participants.|||percentage of participants|||Number
1235387|NCT00618748|Secondary|Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint|CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The scores for mania, depression, and overall illness each range from 1 (normal, not ill) to 7 (very seriously ill).|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1235388|NCT00618748|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1235389|NCT00618748|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1235390|NCT00618748|Secondary|Change From Baseline in Weight at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||kilograms||Standard Deviation|Mean
1235391|NCT00618748|Secondary|Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||millimole/Liter||Standard Deviation|Mean
1235392|NCT00618748|Primary|Percentage of Participants With Adverse Events Leading to Discontinuation|An adverse event (AE) is an untoward medical event associated with the use of the study drug or study procedure, whether or not it is considered related to the study drug or study procedure. Results presented are the percentage of participants who experienced an adverse event that resulted in the discontinuation of the study.|Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|All randomized Participants.|||percentage of participants|||Number
1235393|NCT00618722|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations||From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/mITT population|||participants|||Number
1235394|NCT00618722|Secondary|Change From Baseline in the Cervicomental Angle|The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data|||degrees||Standard Deviation|Mean
1235395|NCT00618722|Secondary|Change From Baseline in Skin Laxity Rating|"Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:~1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT population with available data|||units on a scale||95% Confidence Interval|Least Squares Mean
1235396|NCT00618722|Secondary|Percentage of Participants With a Response in the Subject Global Improvement Rating|"Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.~0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.~Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6."|4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population|||percentage of participants|||Number
1235397|NCT00618722|Secondary|Change From Baseline in Subject Satisfaction With Appearance Rating Scale|The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data|||units on a scale||Standard Deviation|Mean
1235398|NCT00618722|Secondary|Change From Baseline in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data|||units on a scale||Standard Deviation|Mean
1235399|NCT00618722|Primary|Number of Participants With Adverse Events|"The investigator determined the relationship of each adverse event to the administration of study drug.~Severity of adverse events was determined using the following scale:~Mild: The participant is aware of a sign or symptom, but it is easily tolerated~Moderate: Discomfort or interference with usual activity~Severe: Incapacitating, with inability to engage in usual activity.~A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor’s opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:~was fatal~was life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~was a congenital anomaly/birth defect~other significant medical hazard"|From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety and Modified Intent to Treat (mITT) population including all randomized participants who received at least 1 dose of study drug and who had at least 1 post-baseline observation.|||participants|||Number
1235400|NCT00618618|Secondary|Visual Analogue Scale Pain Intensity Rating|Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)|Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12|"Safety/mITT subset with available data at each time point (indicated by N)"|||units on a scale||Standard Deviation|Mean
1235401|NCT00618618|Secondary|Change From Baseline in the Cervicomental Angle|The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||degrees||Standard Deviation|Mean
1235402|NCT00618618|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations||From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/mITT subset|||participants|||Number
1235403|NCT00618618|Secondary|Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT subset|||units on a scale||Standard Deviation|Mean
1235404|NCT00618618|Secondary|Change From Baseline in Skin Laxity Rating|"Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:~1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT subset|||units on a scale||Standard Deviation|Mean
1235405|NCT00618618|Secondary|Percentage of Participants With an SMF Response|Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||percentage of participants|||Number
1235406|NCT00618618|Secondary|Percentage of Participants With a Response in the Subject Global Improvement Rating|"Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.~0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.~Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6."|4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||percentage of participants|||Number
1235407|NCT00618618|Secondary|Change From Baseline in Subject Satisfaction With Appearance Rating Scale|"The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||units on a scale||Standard Deviation|Mean
1235408|NCT00618618|Secondary|Change From Baseline in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||units on a scale||Standard Deviation|Mean
1235409|NCT00618618|Primary|Number of Participants With Adverse Events|"The investigator determined the relationship of each adverse event to the administration of study drug.~Severity of adverse events was determined using the following scale:~Mild: The participant is aware of a sign or symptom, but it is easily tolerated~Moderate: Discomfort or interference with usual activity~Severe: Incapacitating, with inability to engage in usual activity.~A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor’s opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:~was fatal~was life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~was a congenital anomaly/birth defect~other significant medical hazard"|From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/miTT subset|||participants|||Number
1235410|NCT00618540|Secondary|Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD)|The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant.|Day 100 and Month 6||||participants|||Number
1235411|NCT00618540|Secondary|Platelet Engraftment|Incidence of platelet recovery and donor chimerism at Day 100.|Day 100||||participants|||Number
1235412|NCT00618540|Secondary|Incidence of Chronic GVHD|Occurrence of symptoms in any organ system fulfilling the criteria of limited or extensive chronic GvHD (Appendix III), among patients surviving > 90 days with evidence of engraftment. Patients without chronic GvHD will be censored at time of death or last follow-up.|Day 100 and Month 6||||participants|||Number
1235413|NCT00618540|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)|The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant.|Day 100 and Month 6||||participants|||Number
1235414|NCT00618540|Secondary|Neutrophil Engraftment|Incidence of neutrophil recovery and donor chimerism at Day 100.|Day 100||||participants|||Number
1235415|NCT00618540|Secondary|Transplantation-related Death|Count of patients who died by day 100 related to the transplantation.|Day 100||||participants|||Number
1235416|NCT00618540|Primary|Disease-free Survival at 12 Months Post Transplantation|"This outcome is defined as survival with resolution of LCH at 12 months post transplant.~Unresolved disease for over 12 months post-transplant, progressive disease after this time period, recurrence of disease and death from any cause are considered events.~Those who survive with resolution of disease are censored at the date of last contact."|Year 1||||participants|||Number
1235417|NCT00618540|Primary|Overall Survival|Count of patients alive at 1 and 3 years. Deaths from any cause are events. Surviving patients are censored at the date of last contact.|Year 1, Year 3||||participants|||Number
1235418|NCT00618514|Secondary|Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.|Each treated limb was clinically evaluated for the presence of a device-related non-serious adverse event.|6 Months||||Limbs|Participants||Number
1235419|NCT00618514|Secondary|Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months.|Each subject completed a questionnaire to rate their satisfaction with the laser treatment. The score was reported as excellent, good, fair or poor. The best score of excellent was defined as “I am very satisfied with the laser treatment” and the worse score of poor was defined as “I am not satisfied with the laser treatment.” Each treated limb was scored by the patient at 6 months to determine the percent satisfaction at the 6-month time point.|6 months||||Percentage of participants|Participants||Number
1235449|NCT00618072|Secondary|HDL|HDL was measured using two reagents homogeneous systems with selective detergents to homogenize the lipoprotein of interest.|6 months||||mg/dl||Standard Error|Mean
1235450|NCT00618072|Secondary|Diastolic BP|Blood pressure was assessed using NCEP guidelines.|6 months||||mmHg||Standard Error|Mean
1235420|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.|Each subject completed a questionnaire to rate his/her pain. The scale is from 0-10 (0=no pain and 10=worst pain imaginable). Each treated limb was scored by the patient post-procedure and at 6 months to determine the improvement after treatment at the 6-month time point.|6 Months||||percentage of change|Participants|Standard Deviation|Mean
1235421|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).|VDS is a physician’s evaluation of a patient’s ability to work an eight-hour day with or without a support device (i.e., compressive therapy, limb elevation). The patient is scored on a scale of 0-3 (0=asymptomatic and 3=unable to carry out usual activities (patients activities before the onset of disability due to venous disease) even with compression and/or limb elevation). The score represents the degree of disability caused by the venous disease with the best score being 0 and the worse score being 3. Each treated limb was evaluated and scored at baseline and at 6 months.|6 Months||||percentage of change|Participants|Standard Deviation|Mean
1235422|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).|VCSS is a physician’s evaluation of 10 pre-determined clinical signs or attributes of venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, active ulcer duration, active ulcer diameter and compression therapy). Each attribute receives a score from 0-3 (0=absent and 3=severe). The best total overall score is 0 (all ten attributes are absent) and the worse overall score is 30 (all ten attributes are severe). Each treated limb was evaluated and scored at baseline and at 6 months.|6 Months||||percentage change|Participants|Standard Deviation|Mean
1235423|NCT00618514|Primary|Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months.|Each treated limb was clinically evaluated for the presence of a device-related serious adverse event.|6 Months||||Limbs|Participants||Number
1235424|NCT00618514|Primary|Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months.|The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation.|6 Months||||Limbs|Participants||Number
1235425|NCT00618449|Primary|Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]||1-year post-treatment|Per protocol.|||Participants|||Number
1235426|NCT00618436|Secondary|Incidence of Adverse Events||discharge; 3 and 6 months following injury|||||||
1235427|NCT00618436|Secondary|Disability Rating Scale (DRS)|The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable.|Discharge; 3 and 6 months following injury|All patients|||units on a scale||Full Range|Mean
1235428|NCT00618436|Secondary|Extended Glasgow Outcome Score|This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls.|at discharge; 3 and 6 months following injury|All patients|||units on a scale||Full Range|Mean
1235429|NCT00618436|Primary|Seizure Incidence|This was the number of patients in each group who demonstrated seizure activity during the course of the study|Duration of study, up to 6 months after the injury||||Participants|||Number
1235430|NCT00618410|Secondary|Eosinophil Influx [Post-allergen]|The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.|after antigen challenge||||percentage of white blood cells||Full Range|Median
1235431|NCT00618410|Secondary|Eosinophil Influx [Pre-allergen]|The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.|before antigen challenge||||percentage of white blood cells||Full Range|Median
1235432|NCT00618410|Secondary|Change From Diluent Challenge Contralateral Histamine Level at Antigen Challenge|"After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.~Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.~The number reported in this outcome measure was calculated by subtracting the contralateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative."|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.|||ng/mL||Full Range|Median
1235451|NCT00618072|Secondary|Systolic BP|Blood pressure was assessed using NCEP guidelines.|6 months||||mmHg||Standard Error|Mean
1235452|NCT00618072|Secondary|Waist Circumference||6 months||||cm||Standard Error|Mean
1235453|NCT00618072|Secondary|HOMA-IR|HOMA-IR was calculated by the formula: fasting insulin (uU/mL) times fasting glucose (mg/L) divided by 22.5.|6 months||||HOMA-IR score||Standard Error|Mean
1235454|NCT00618072|Secondary|Body Weight|Body weight measurement was performed three times and averaged by a single study coordinator.|6 months||||kg||Standard Error|Mean
1235433|NCT00618410|Secondary|Change From Diluent Challenge Ipsilateral Histamine Level at Antigen Challenge|"After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.~Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.~The number reported in this outcome measure was calculated by subtracting the ipsalateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative."|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.|||ng/mL||Full Range|Median
1235434|NCT00618410|Secondary|Change From Diluent Challenge Ipsilateral Secretion Weight at Antigen Challenge|Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Ipsilateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.|||milligrams||Full Range|Median
1235435|NCT00618410|Primary|Change From Diluent Challenge Contralateral Secretion Weight at Antigen Challenge|Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Contralateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.|||milligrams||Full Range|Median
1235436|NCT00618371|Secondary|Proviral DNA Response, HIV-1 Sequence Variation Levels of Cell Associated HIV DNA and Genetic Variation in HIV During Raltegravir Addition in Individuals Who Have Declines in HIV|We planned to compare HIV DNA levels and HIV genetic variation in individuals with and without ≥10 fold decreases in HIV RNA. As none of the patients had a decline in viral RNA, this analysis could not be readily analyzed|4 weeks|0 participants were analyzed because no patients had ≥10 fold decrease in viral RNA. As described in patient outcome description, we would sequence patients only if a ≥10- fold decrease in viremia occurred, Since no one experienced ≥10 fold decrease in viremia, no sequencing could be performed.||||||
1235437|NCT00618371|Primary|Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load|HIV RNA levels were determined with a non-commercial, sensitive single copy assay for HIV. The primary outcome measure was to determine the number of individuals with ≥10fold decrease in HIV RNA|4 weeks|Number of participants based on estimates of how many will have decreased viral RNA levels. If 10 participants do not have decreased RNA, the number of patients with potential for decrease is <15% of all suppressed patients.|||participants|||Number
1235438|NCT00618332|Secondary|Changes in RQLQ: Eye|The RQLQ eye range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1235439|NCT00618332|Secondary|Changes in RQLQ: Emotional|The RQLQ emotional range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|There were one patient in the Mometasone Furoate group with a missing value.|||units on a scale||Standard Deviation|Mean
1235440|NCT00618332|Secondary|Changes in RQLQ: Nasal|The RQLQ nasal range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1235441|NCT00618332|Secondary|Changes in RQLQ: Practical|The RQLQ practical range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1235442|NCT00618332|Secondary|Changes in RQLQ: Non-Nasal/Eye|The RQLQ non-nasal/eye range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1235443|NCT00618332|Secondary|Changes in RQLQ: Sleep|The RQLQ sleep range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1235444|NCT00618332|Secondary|Changes in RQLQ: Activity|The RQLQ activity range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1235445|NCT00618332|Secondary|Changes in RQLQ: Overall|The RQLQ is a disease-specific measure of a patient’s quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0–6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1235446|NCT00618332|Primary|Global Assessment|"Global Assessment: 3=significantly improved, 2=moderately improved,~1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse"|at week 2|There were one patient in the Mometasone Furoate group and two patients in the Placebo group with missing values.|||units on a scale||Standard Deviation|Mean
1235447|NCT00618072|Secondary|Adiponectin|Total adiponectin was measured with a commercial ELISA kit (Millipore/Linco Research, St. Charles, MO) in the laboratory of Dr. Philipp Scherer.|6 months||||ug/mL||Standard Error|Mean
1235448|NCT00618072|Secondary|Triglycerides|Triglycerides were measured by enzymatic immunoassay on an AU400 chemistry auto-analyzer with commercially available enzymatic reagents.|6 months||||mg/dl||Standard Error|Mean
1235455|NCT00618072|Primary|Fasting Insulin|Insulin was determined with a Siemens Immulite assay with respective intra-and inter-CV's 5.7 and 5.9%, and no cross reactivity to pro-insulin.|6 months|The final data-set consisted of 44 study participants, after exclusion of two study completers due to clinical conditions which appeared de novo (asthma requiring high dose prednisone and growth hormone deficiency diagnosed mid-study) - applicable to all study outcomes.|||uIU/mL||Standard Error|Mean
1235456|NCT00617981|Secondary|Safety||3 years|||||||
1235457|NCT00617981|Secondary|Time to Local Recurrence.||3 years|||||||
1235458|NCT00617981|Secondary|Time to Definite Worsening as Per Patient-Reported Outcomes||3 years|||||||
1235459|NCT00617981|Secondary|Overall Survival as Measured by Time From Randomization to Death or the End of the Study.||3 years|||||||
1235460|NCT00617981|Primary|Progression Free Survival Will be Measured From the Date of Randomization to the First Date on Which One of the Following Occurs. o Local Recurrence o Any New Distant Intrahepatic HCC Tumor o Any New Extrahepatic HCC Tumor o Death From Any Cause||3 years||||Time to Progression (months)||95% Confidence Interval|Number
1235461|NCT00617942|Secondary|Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity|Please note that these events represent toxicities that were experienced during treatment, but that does not mean that all toxicities were indeed deemed related to study treatment.|1 year||||participants|||Number
1235462|NCT00617942|Primary|Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;|These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.|1 year||||participants|||Number
1235463|NCT00617929|Secondary|Acute Graft-vs-host Disease|"Percent of patients with Acute Graft-vs-host Disease - a process where T-cells present in the donor's bone marrow at the time of transplant identify the transplant patient as non-self' and attack the patient's skin, liver, stomach, and/or intestines."|Day 30-100||||percentage of participants|||Number
1235464|NCT00617929|Secondary|Chimerism|Occurrence of genetically distinct cell types in a single organism|Day 28 post transplantation||||percentage of donor cells||Full Range|Median
1235465|NCT00617929|Secondary|Survival|Percent of patients alive from beginning of study to one year post transplantation|One year post transplantation||||percentage of participants|||Number
1235466|NCT00617929|Secondary|Time to Primary Neutrophil Engraftment|Time to primary neutrophil engraftment is defined as the percent of patients with an absolute neutrophil count (ANC) of 500 or more neutrophils in a cubic millimeter of blood.|Day 42 post transplantation||||percentage of participants|||Number
1235467|NCT00617929|Secondary|Treatment-related Death|Percent of patients who died related to the treatment in this study.|Day 100 post transplantation||||percentage of participants|||Number
1235468|NCT00617929|Primary|Survival at 100 Days Post Transplant|Percent of patients alive from beginning of study to Day 100 post transplantation|Day 100 post transplantation||||percentage of participants|||Number
1235469|NCT00617929|Primary|Rate of Sustained Donor Engraftment|Rate of Sustained Donor Engraftment is defined as the percent of paticipants with an absolute neutrophile count (ANC) of 500 or more without a subsequent graft rejection.|Day 42 post transplantation||||percentage of participants|||Number
1235470|NCT00617903|Secondary|Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)||At Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
1235471|NCT00617903|Secondary|Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12||At Weeks 4, 8 and 12||||Percentage of participants|||Number
1235472|NCT00617903|Secondary|Patients’ Opinion on Cosmetic Acceptability at End of Study|Patient’s opinion on cosmetic acceptability: 1 - very good; 2 – good; 3 – satisfactory; 4 – poor; 5 - no opinion|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases|||Percentage of participants|||Number
1235473|NCT00617903|Secondary|Patients’ Rating of Overall Improvement at End of Study|Patient’s rating of overall improvement: 1 – excellent; 2 – good; 3 – fair; 4 - no improvement; 5 – worse|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases|||Percentage of participants|||Number
1235474|NCT00617903|Secondary|Investigator’s Rating of Overall Improvement at End of Study|Investigator’s rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 – deterioration|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases)|||Percentage of participants|||Number
1235475|NCT00617903|Secondary|Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
1235476|NCT00617903|Secondary|Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Scores on a scale||Standard Deviation|Mean
1235477|NCT00617903|Secondary|Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|At Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
1235478|NCT00617903|Secondary|Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8 and 12||||Percentage of participants|||Number
1235479|NCT00617903|Secondary|Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Scores on a scale||Standard Deviation|Mean
1235480|NCT00617903|Secondary|Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|At Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
1235481|NCT00617903|Secondary|Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Scores on a scale||Standard Deviation|Mean
1235482|NCT00617903|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|At Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
1235483|NCT00617903|Secondary|Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)||Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of Inflammatory lesions||Standard Deviation|Mean
1235484|NCT00617903|Secondary|Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12||Baseline and Weeks 4, 8 and 12||||Inflammatory lesions||Standard Deviation|Mean
1235485|NCT00617903|Secondary|Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)||At Weeks 4, 8, 12 and End of Study (LOCF)||||Inflammatory lesions||Standard Deviation|Mean
1235486|NCT00617903|Primary|Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and End of Study (Week 12)||||Percentage of participants|||Number
1235487|NCT00617903|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|At End of Study (Week 12)||||Percentage of participants|||Number
1235488|NCT00617903|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)||Baseline and End of Study (Week 12)||||Inflammatory lesions||Standard Deviation|Mean
1235489|NCT00617890|Secondary|Duration of Response (Groups 2 and 3 Only)|This is a measure of the amount of time in which the tumor responded to therapy.|From time of documented response until disease progression or data analysis cut off (Up to 3.4 years)|Group 2 and 3 participants; this outcome was not evaluated due to early termination of the study||||||
1235490|NCT00617890|Secondary|Overall Survival (Groups 2 and 3 Only)|This is a measure of the time of survival from first dose to documentation of death|From start of treatment until death or data analysis cut off (Up to 3.4 years)|Group 2 and 3 Participants|||Months||95% Confidence Interval|Median
1235491|NCT00617890|Secondary|Time to Disease Progression (Groups 2 and 3 Only)|This is a measure of the time from the start of the study to the time of documented disease progression.|From the start of treatment until disease progression or data analysis cut off (Up to 3.4 years)|All participants in Groups 2 and 3; this outcome was not evaluated due to early termination of the study||||||
1235492|NCT00617890|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Treatment-emergent adverse events are those that occur after participants have received study treatment, or existing adverse events that occurred during screening that increase in severity after study treatment. Adverse events in the Group 1: 0.3 mg/kg arm that occurred after switching to the 10 mg/kg dose are displayed under the originally assigned treatment.|Up to 2 years|All participants receiving study drug.|||Participants|||Number
1235493|NCT00617890|Secondary|Incidence of Anti-robatumumab Antibodies|For biological agents, it is possible for the host (participant) to develop antibodies to the agent. This outcome measure was planned to find out the number of participants who developed the antibodies after treatment with robatumumab.|Up to 2 years|This outcome was not evaluated due to early termination of the study.||||||
1235494|NCT00617890|Secondary|Area Under the Concentration-time Curve (AUC) of Serum Levels of Robatumumab (Group 1 Only)||End of infusion on Day 1, and then prior to surgery, before and after the 2nd, 3rd, and 8th doses (up to 20 weeks)|Group 1, both dose levels: this outcome was not evaluated due to early termination of the study.||||||
1235495|NCT00617890|Secondary|Time Until Tumor Relapse (Group 1 Only)|This is a measure of the time from the start of the study to documented relapse of disease.|From start of treatment until relapse or data analysis cut off (Up to 3.4 years)|Group 1 participants; this outcome was not evaluated due to early termination of the study.||||||
1235496|NCT00617890|Secondary|Overall Survival|This is a measure of the number of participants known to be alive at the time of data analysis for this study.|From start of treatment until death or data analysis cut off (Up to 3.4 years)|All study participants|||Participants|||Number
1235497|NCT00617890|Primary|Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only)|Responses to treatment (complete response, partial response, or stable disease) confirmed by central review for Participants in Group 2. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria.|Up to 1 year following the start of study therapy|Group 2 participants with evaluable data.|||Participants|||Number
1235498|NCT00617890|Primary|Number of Participants With >= 25% Change in Tumor Proliferation After Exposure to Robatumumab (Group 1 Only)|Tumor proliferation was measured using Ki-67 levels. Ki-67 is nuclear protein associated with cellular proliferation.|Approximately 14 days|Group 1 Participants; this outcome was not evaluated due to early termination of the study.||||||
1235499|NCT00617890|Primary|Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only)|This is a measure of the number of participants with a complete response (CR) or partial response (PR) to therapy, confirmed by central review. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria.|Up to 1 year following the start of study therapy|Participants in Group 3 with evaluable data.|||Participants|||Number
1235510|NCT00617773|Other Pre-specified|12-Month Survival Rate|Rate of patients alive 12 months after starting therapy with the investigational product.|12 months from the start of study treatment.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.|||percentage of participants||95% Confidence Interval|Number
1235500|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain B)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||percentages of participants||95% Confidence Interval|Mean
1235501|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||percentages of participants||95% Confidence Interval|Mean
1235502|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||percentages of participants||95% Confidence Interval|Mean
1235503|NCT00617851|Secondary|Number of Subjects With at Least One Unsolicited Adverse Event|Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).|3 weeks after vaccination|The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.|||participants|||Number
1235504|NCT00617851|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms|Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.|7 days after vaccination|The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.|||Participants|||Number
1235505|NCT00617851|Secondary|Geometric Mean Titers (GMTs), by Vaccine Group and Strain|The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||titers||95% Confidence Interval|Geometric Mean
1235506|NCT00617851|Primary|Geometric Mean Titers (GMTs), by Vaccine Lots|The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||Titers||95% Confidence Interval|Geometric Mean
1235507|NCT00617773|Post-Hoc|Progression Free Survival in Patients Without Ascites and no Visceral Disease at Baseline Versus Patients With Ascites and/or Visceral Disease at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease and ascites at baseline were considered for this analysis.|||weeks||95% Confidence Interval|Median
1235508|NCT00617773|Post-Hoc|Progression Free Survival in Patients With and Without Visceral Disease at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease at baseline were considered for this analysis.|||weeks||95% Confidence Interval|Median
1235509|NCT00617773|Post-Hoc|Progression Free Survival in Patients With and Without Ascites at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.|||weeks||95% Confidence Interval|Median
1235511|NCT00617773|Other Pre-specified|Overall Survival|Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.|From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.|||weeks||Full Range|Median
1235512|NCT00617773|Other Pre-specified|Progression Free Survival (PFS)|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks.|All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.|||weeks||Full Range|Median
1235513|NCT00617773|Other Pre-specified|Clinical Benefit|"The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown.~Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population.~The evaluation of target and non-target lesions is described at the Outcome Measure titled Best Overall Response. CR: Complete Response; PR: Partial Response; SD: Stable Disease."|From start of study treatment until the end of Cycle 3 (24 weeks).|All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.|||percentage of participants||95% Confidence Interval|Number
1235514|NCT00617773|Secondary|Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses|Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.|Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1.|All patients enrolled in the study that received at least 8 doses of investigational product were considered to this analysis.|||µg/mL||Standard Deviation|Mean
1235515|NCT00617773|Secondary|Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses.|Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.|Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.|||µg/mL||Standard Deviation|Mean
1235516|NCT00617773|Secondary|Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%).|Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.|From the first dose of investigational product up to 30 days after the last dose of investigational product||||participants|||Number
1235517|NCT00617773|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|A listing of all adverse events is located in the Reported Adverse Event module.|From the first dose of investigational product up to 30 days after the last dose of investigational product|All patients enrolled in the study that received at least 1 dose of investigational product were considered for safety evaluation.|||participants|||Number
1235518|NCT00617773|Primary|Best Overall Response|"Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125).~Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).|All patients enrolled in the study that received at least 4 doses of investigational product were considered to the efficacy evaluation.|||participants|||Number
1235519|NCT00617734|Secondary|Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab|No data for biomarkers and serum antibodies were collected due to lack of an appropriate validated assay.|Biomarkers [pre-dose, Cycle 1 (Day 15), (Cycle 2 (Day 1), and end of treatment]; Immunogenicity [pre-dose, prior to first infusion for Cycle 3, Cycle 5, and 30-day safety follow-up]|No participants were analyzed due to lack of an appropriate validated assay.||||||
1235520|NCT00617734|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths|TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs including serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events section of this report.|Baseline through study completion (up to 29.63 months)|Randomized participants who received at least 1 dose of study drug.|||participants|||Number
1235521|NCT00617734|Secondary|Duration of Response|The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of PD or death. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of PD.|Date of first response to the date of PD or death due to any cause (up to 23.98 months)|Randomized participants who received at least 1 dose of study drug and had CR or PR. No participants were censored for duration of response.|||months||95% Confidence Interval|Median
1236129|NCT00612560|Primary|Expression of Estrogen Receptor (ER-beta)|Mean percentage of cells expressing estrogen receptor (ER-beta)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis|||percentage of cells||Standard Deviation|Mean
1235522|NCT00617734|Secondary|Overall Survival (OS)|OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.|Baseline to date of death from any cause (up to 29.63 months)|Randomized participants who received at least 1 dose of study drug. Eleven (11) participants in IMC-A12 (Cixutumumab) group and 6 participants in IMC-A12 (Cixutumumab) + Cetuximab group were censored for analysis.|||months||95% Confidence Interval|Median
1235523|NCT00617734|Secondary|Percentage of Participants With PFS at 6 Months|PFS at 6 months was defined as the percentage of participants who have neither experienced PD nor died at 6 months after the date of randomization. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 6 months divided by the total number of participants treated then multiplied by 100.|6 months|Randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1235524|NCT00617734|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100.|Baseline to measured PD (up to 27.66 months)|Randomized participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
1235525|NCT00617734|Primary|Progression-Free Survival (PFS)|PFS was defined as the interval from randomization until PD or death, whichever occurred first. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0) criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.|Baseline to measured PD (up to 27.66 months)|Randomized participants who received at least 1 dose of study drug. Seven (7) participants in IMC-A12 (Cixutumumab) and 4 participants in IMC-A12 (Cixutumumab) + Cetuximab were censored for analysis.|||months||95% Confidence Interval|Median
1235526|NCT00617708|Primary|Progression-Free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible patients in the Phase II portion of the study.|||months||95% Confidence Interval|Median
1235527|NCT00617708|Secondary|Toxicity|Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1235528|NCT00617708|Secondary|Response|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|Eligible patients in the Phase II portion of the study with measurable disease and adequate response assessment.|||percentage of participants||95% Confidence Interval|Number
1235529|NCT00617708|Primary|Maximum Tolerated Dose Determination|Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).|28 days|Phase I patients receiving at least three doses of the assigned dose during Cycle 1 or whom developed a DLT.|||mg/kg IMC-A12|||Number
1235530|NCT00617708|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible patients in the Phase II portion of the study.|||months||95% Confidence Interval|Median
1235531|NCT00617669|Secondary|PSA Response|PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set|||Participants|||Number
1235532|NCT00617669|Secondary|Health Related Quality of Life|Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set|||Months||Inter-Quartile Range|Median
1235533|NCT00617669|Secondary|Pain Response|Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2.|||Participants|||Number
1235620|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|12 months||||Participants|||Number
1235534|NCT00617669|Secondary|Time to Pain Progression|Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set|||Months||Inter-Quartile Range|Median
1235535|NCT00617669|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Median time (in months) from randomisation until first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)||||Months||Inter-Quartile Range|Median
1235536|NCT00617669|Secondary|Incidence of Skeletal Related Events|Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set|||Months||Inter-Quartile Range|Median
1235537|NCT00617669|Secondary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline|Patients were followed for progression up to 40 months|Full Analysis Set|||Months||Inter-Quartile Range|Median
1235538|NCT00617669|Primary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method.|Patients were followed for survival up to 40 months|Full Analysis Set|||Months||Inter-Quartile Range|Median
1235539|NCT00617604|Secondary|Number of Participants With Adverse Events|"Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing.~A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:~Resulted in death.~Was life-threatening.~Resulted in persistent or significant disability/incapacity.~Resulted in congenital anomaly or birth defect.~Required patient hospitalization or led to prolongation of hospitalization~Was considered a medically important event.~All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE"|6 Months|Safety analysis set (all randomized participants who received at least one dose of study drug).|||participants|||Number
1235540|NCT00617604|Secondary|Percentage of Participants With Treatment Failure at Month 6|Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235541|NCT00617604|Secondary|Percentage of Participants With Delayed Graft Function|Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.|1 week|Full analysis set|||percentage of participants|||Number
1235542|NCT00617604|Secondary|Percentage of Participants With Efficacy Failure at Month 6|"Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up.~The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235543|NCT00617604|Secondary|GFR Measured by Iothalamate Clearance at Month 6|GFR measured using the iothalamate clearance method and determined by a central laboratory.|Month 6|Full analysis set participants with available data|||mL/minute||Standard Deviation|Mean
1235544|NCT00617604|Secondary|Change From Month 1 in Creatinine Clearance|The creatinine clearance was calculated according to the Cockcroft-Gault formula.|Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (90, 84) and at Month 3 and Month 6 (indicated by n)."|||mL/minute||Standard Deviation|Mean
1235545|NCT00617604|Secondary|Change From Month 1 in Glomerular Filtration Rate (GFR)|The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.|Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (98, 93 participants respectively) and at Month 3 and Month 6 (indicated by n)."|||mL/min/1.73 m²||Standard Deviation|Mean
1235546|NCT00617604|Secondary|Change From Month 1 in Serum Creatinine||Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (99 and 94 participants in each treatment group respectively) and at Month 3 and Month 6 (indicated by n)."|||µmol/L||Standard Deviation|Mean
1235547|NCT00617604|Secondary|Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6|The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235599|NCT00617305|Secondary|Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean percent change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. A decrease in log-transformed measurement value (pg/mL) indicates improvement for this patient population.|Baseline to Week 48|One patient (Any Placebo) was not evaluated for NT-proBNP. One patient (Placebo Only) had no baseline measurement, so no statistical analyses for change from baseline are given for the placebo only group (patient was only subject in this group).|||pg/mL (log-transformed)||Standard Deviation|Mean
1235548|NCT00617604|Secondary|Maximum Histological Grade of All Biopsies After Local Review|"The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used.~Acute T-cell mediated rejection:~Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;~Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;~Grade IIA: mild to moderate intimal arteritis;~Grade IIB: severe intimal arteritis comprising >25% of the luminal area;~Grade III: “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.~Acute antibody-mediated rejection:~Grade I: acute tubular necrosis-like – complement split product positive (C4d+), minimal inflammation;~Grade II: capillary-margination and/or thromboses, C4d+~Grade III: arterial – v3, C4d+."|6 months|Full analysis set|||percentage of participants|||Number
1235549|NCT00617604|Secondary|Graft Survival|"Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information.~The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235550|NCT00617604|Secondary|Patient Survival|Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235551|NCT00617604|Secondary|Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6|"Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235552|NCT00617604|Secondary|Percentage of Participants With Steroid-resistant Acute Rejection at Month 6|"A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category.~The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235553|NCT00617604|Secondary|Percentage of Participants With Clinically Treated Acute Rejection at Month 6|Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235554|NCT00617604|Secondary|Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6|Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235555|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235556|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235557|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:~Acute antibody-mediated rejection - documented anti-donor antibody (‘suspicious for’ if antibody not demonstrated):~Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;~Grade II: capillary-margination and/or thromboses, C4d+~Grade III: arterial - v3, C4d+.~A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1235618|NCT00617279|Secondary|Patients Experiencing Major Adverse Events Through 12 Months Post-procedure|A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|12 months||||Participants|||Number
1235558|NCT00617604|Primary|Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:~Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;~Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;~Grade IIA: mild to moderate intimal arteritis;~Grade IIB: severe intimal arteritis comprising >25% of the luminal area;~Grade III: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.~A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set (all randomized and transplanted participants who received at least 1 dose of study drug)|||percentage of participants||90% Confidence Interval|Number
1235559|NCT00617591|Secondary|Occurrence of Induction Toxicities|"Tolerability of full dose Revlimid® with full dose Doxil® in combination with reduced schedule dexamethasone was to be assessed during Cycle 1 and at the start of Cycle 2 using, whenever possible, the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0.~Due to increased neutropenia and fatigue, toxicities were reviewed after the first 29 participants were enrolled."|24 Months|First 29 participants with the PLD starting dose of PLD 40 mg/m^2, due to increased neutropenia and fatigue.|||percentage of participants|||Number
1235560|NCT00617591|Secondary|2 Year Overall Survival (OS) Rate|Percentage of participants with Overall Survival in response to Dd-R in newly diagnosed multiple myeloma patients with active disease. Overall survival is time from study entry to death of any cause.|24 Months|All participants|||percentage of participants|||Number
1235561|NCT00617591|Secondary|Median Progression Free Survival (PFS) in Months|PFS: Time from study entry to progression/relapse or death from study entry to death of any cause, assessed using International Myeloma Working Group Response Definitions. Progressive Disease (PD): One of the following criteria must be met: a. Increase of 25% or greater in serum M protein (absolute increase greater or equal to 0.5g/dl); b. Increase of 25% or greater in urine M protein (absolute increase greater than 200 mg/24h); c. Increase of 25% or greater in the difference between the involved and uninvolved free light chain (absolute increase greater than 10 mg/dl); d. Increase of 25% or greater in bone marrow plasma cell percentage (absolute percent greater than 5% in case the patient was in CR and 10% otherwise); i.e. Definite development of new bone lesions or soft tissue plasmacytomas, or increase in the size of existing plasmacytomas by greater or equal to 25%. Development of hypercalcemia (serum calcium > 11.5 mg/dl) attributable only to the plasma cell dyscrasia.|24 Months|All participants|||months||95% Confidence Interval|Median
1235562|NCT00617591|Primary|Percentage of Participants With Very Good Partial Remission (VGPR) or Better|Quality of response: % Complete Response (CR) + Very Good Partial Remission (VGPR) to induction Dd-R as assessed using International Myeloma Working Group Response Definitions. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.|24 Months|All participants|||percentage of participants|||Number
1235563|NCT00617591|Primary|Overall Response Rate (ORR) - Percentage of Participants With Partial Response or Better With Induction Regimen|ORR assessed using International Myeloma Working Group Response Definitions. Partial Remission (PR): A greater than 50% reduction in the serum paraprotein, and if present, a greater than 90% reduction in the urine M protein excretion. Patients must also have a decrease by 50% in the size of soft tissue plasmacytoma. If serum and urine M protein are not measurable, a 50% or greater decreased in the difference of the involved and uninvolved free light chain. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.|24 Months|All participants|||percentage of participants|||Number
1235564|NCT00617539|Primary|Number of Patients Experiencing a Clinical Benefit|The number of patients experiencing a clinical benefit is the sum of patients with an objective response plus patients with stable disease at ≥ 16 weeks from cycle 1 day 1 (first day of treatment). If a patient did not come back for a follow up scan after clinical deterioration, then they were only considered stable up to the time of the last scan they had per protocol.|From 1 day 1 (first day of treatment) every 8 weeks until scan shows disease progression or up to 2 years||||Participants|||Count of Participants
1235565|NCT00617539|Secondary|Number of Patients Whose Circulating Tumor Cells (CTCs) Decreased From >5 to <5 CTCs Per 7.5 mL|CTCs were measured in blood using the Cellsearch(R) assay in 14 of the 20 patients measured at baseline|CTCs drawn on cycle 1 day 1, collection at 8 week intervals on patients who did not progress on their 8 week scans up to 2 years|Of 20 patients with CTCs measured at baseline, 14 were also measured at 8 weeks|||participants|||Number
1235566|NCT00617539|Secondary|Overall Time of Survival|Time from initiation of study participation until death|Time from initiation of study participation until death or up to 3 years||||Days||Full Range|Median
1235567|NCT00617539|Secondary|Time to First Progression in CNS|"Imaging at 8-week intervals to assess response to treatment. A modified RECIST 1.0 criteria was used to assess response and time to progression in the CNS for patients with progressing brain metastases. In this modified RECIST criteria, CNS lesions <1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions <1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.~If patient did not come back for a follow up scan after clinical deterioration, patient was only considered stable up to the time of the last scan per protocol and time to progression would be from cycle 1 day 1 to the last scan they completed that was stable."|Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years||||Days||Full Range|Median
1235568|NCT00617539|Primary|Number of Patients With Objective Treatment Response (Complete or Partial) in the CNS|Imaging was performed at 8-week intervals to assess response to treatment. Patients with known or suspected leptomeningeal disease were deemed to have a complete response if CSF cytology converted to negative (if positive at baseline) and all meningeal enhancement or nodularity of brain and/or spine MRI resolved. A modified RECIST 1.0 criteria was used to assess CNS response for patients with new or progressing brain metastases. In this modified RECIST criteria, CNS lesions <1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions <1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.|Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years||||Participants|||Count of Participants
1235569|NCT00617461|Secondary|Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations|Steady-state average (Cave, ss), maximum (Cmax, ss), and minimum (Cmin,ss) plasma concentration of gabapentin in each participant were estimated using the gabapentin plasma concentration data and with the aid of a population pharmacokinetic model. Dispersion is represented by the fifth to ninety-fifth percentile, though labeled as “Full Range.” A total of 10 blood samples were collected per participant over the Baseline, Period 1, and Period 2 at various timepoints during the dosing interval. Plasma concentration of gabapentin in these samples was measured.|A total of 10 blood samples (2 samples at each visit) were collected per participant at Baseline, and the Week 1 and Week 4 visits for each period|Drug concentration data were available from 89 ITT Population participants. Data from 7 of these participants had one concentration with less than half of the first percentile of the concentrations observed at ss and were defined as non-compliant and were excluded from the pharmacokinetic (PK) analysis.|||micrograms per milliliter||Full Range|Geometric Mean
1235570|NCT00617461|Secondary|Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF|The BPI assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact to 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where scores range from 0 to 10 (0=no impact to 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of treatment)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and could thus not be included in the analysis.|||points on a scale||Standard Error|Least Squares Mean
1235571|NCT00617461|Secondary|Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for sleep interference during the GEn 1200 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
1235572|NCT00617461|Secondary|Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose within each treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response data to this questionnaire and could thus not be included in the analysis.|||participants|||Number
1235573|NCT00617461|Secondary|Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose, independent of treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response to this questionnaire and thus could not be included in the analysis.|||participants|||Number
1235574|NCT00617461|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose within each treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.|||participants|||Number
1235672|NCT00616967|Secondary|Baseline and Change in Continuous Variables (e.g., Candidate Gene Methylation, Expression Profiles, Tissue, and Peripheral Blood Mononuclear Cell Histone Acetylation)||Time of breast cancer surgery|||||||
1235575|NCT00617461|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved Data are summarized by dose, independent of treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.|||participants|||Number
1235576|NCT00617461|Secondary|Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commercial Tylenol) during treatment and multiplying that by 500 mg. Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for rescue medication usage during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||milligrams||Standard Error|Least Squares Mean
1235577|NCT00617461|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period|Baseline and end of treatment scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (end of treatment). Percent reduction from baseline was calculated as the [(end of treatment score minus the baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis.|||participants|||Number
1235578|NCT00617461|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|Baseline and end of treatment (EOT) scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (EOT). Percent reduction from baseline was calculated as the [(EOT score minus baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||participants|||Number
1235579|NCT00617461|Secondary|Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period."|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current morning pain during the GEn 1200 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
1235580|NCT00617461|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF|Night-time worst pain is defined as the participant's assessment of their worst pain intensity between going to bed and rising in the morning. Participants recorded night-time worst pain in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for primary endpoint. Change from baseline = the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
1235619|NCT00617279|Secondary|Patients Experiencing Major Adverse Events Through 6 Months Post-procedure|A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|6 months||||Participants|||Number
1235673|NCT00616967|Secondary|Long Term Outcomes||Indefinite survival analysis|||||||
1235674|NCT00616967|Secondary|Baseline and Change in Markers of Apoptosis and Proliferation||Time of breast cancer surgery|||||||
1235581|NCT00617461|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF|Night-time is defined as the time between going to bed in the evening and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
1235582|NCT00617461|Secondary|Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period."|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current evening pain during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
1235583|NCT00617461|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|Day-time worst pain is defined as the participant's assessment of their worst pain intensity between rising in the morning and going to bed at night. Day-time worst pain was recorded in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
1235584|NCT00617461|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
1235585|NCT00617461|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period|Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. The by period summary is provided as a sensitivity analysis for the primary analysis.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24 hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis.|||points on a scale||Standard Deviation|Mean
1235586|NCT00617461|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data|Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants rated their API over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as end of treatment minus baseline. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24-hour API assessments during the GEn 3600mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
1235587|NCT00617409|Secondary|Overall Survival (OS)|To evaluate the survival of all patients enrolled on an intent-to-treat basis. Overall survival per treatment arm.|Up to 24 months|All participants.|||months||95% Confidence Interval|Median
1235588|NCT00617409|Primary|Tumor Response Rate (RR)|Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|12 months|All participants.|||participants|||Number
1235589|NCT00617396|Primary|Adequate Relief in Pain Score During Treatment|"Biweekly relief in pain Biweekly subjects were asked whether they had adequate relief of pain. It was binary questionnaire i.e.-  Did you have adequate relief of pain in last two weeks? 1) yes 2) no The measure is percentage of subjects who said yes who had adequate relief of pain."|8 weeks|There was no exact statistical test used to determine the sample size. It is based on the capacity of site to recruit subjects.|||percentage of subjects|||Number
1235590|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|24 Months||||units on a scale||Standard Deviation|Mean
1235591|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|12 Months||||units on a scale||Standard Deviation|Mean
1235592|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|6 Months||||units on a scale||Standard Deviation|Mean
1235593|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|3 Months||||units on a scale||Standard Deviation|Mean
1235594|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|30 Days||||units on a scale||Standard Deviation|Mean
1235595|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are numerically transformed to produce a range of 0–100, with higher values indicating greater functional activity.|Baseline||||units on a scale||Standard Deviation|Mean
1235596|NCT00617357|Primary|Incidence of Wound Events|Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.|Postoperatively up to 24 months|80 patients were enrolled and received Strattice Reconstructive Tissue Matrix to support the repair and were included in the Intent to Treat (ITT) population.|||participants|||Number
1235597|NCT00617305|Secondary|Overall Survival, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48|Overall survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of death after a given time.|Baseline to Week 48+|The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Overall Survival|||Probability of death occurring (%)||95% Confidence Interval|Number
1235598|NCT00617305|Secondary|Time to Clinical Worsening of PAH, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48|The time to clinical worsening was defined as the time from enrollment to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, or initiation of chronic parenteral prostanoid therapy. Results are presented as the Kaplan-Meier estimate (% probability) of having clinical worsening after a given time.|Baseline to Week 48+|The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Time to Clinical Worsening|||Probability of clinical worsening (%)||95% Confidence Interval|Number
1235600|NCT00617305|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class (LOCF) Measured at Weeks 4, 12, 24, 36 and 48.|The primary analysis of this secondary outcome measure is change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. WHO categories are 1 to 4 with the worst category being 4. Improvement is represented by a change in category to a lower number (for example, change from category 3 to 2), and deterioration is represented by a change in category to a higher number (for example, change from category 2 to 4). No change is represented by no change in category (for example, category 2 which remains 2).|Baseline to Week 48|All enrolled Population|||participants|||Number
1235601|NCT00617305|Secondary|Change From Baseline in the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life (QOL) Survey Overall Score Measured at Weeks 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 12, 36, and 48 were also evaluated. Lower scores and decreases from baseline represent improved functioning and QOL. The CAMPHOR survey was not assessed at Week 4. The total CAMPHOR score scale ranges from 0 (good) to 25 (poor). A reduction in score over time represents improvement in this patient population.|Baseline to Week 48|All enrolled Population|||units on a scale||Standard Deviation|Mean
1235602|NCT00617305|Secondary|Change in Dyspnea Index Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. The dyspnea index measures the degree of breathlessness after completion of the 6MWT using a scale of 0 to 10, with 0 indicating no breathlessness and 10 indicating maximum breathlessness.|Baseline to Week 48|All enrolled Population|||units on a scale||Standard Deviation|Mean
1235603|NCT00617305|Secondary|Change From Baseline in Six Minute Walk Distance (6MWD) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. An increase in measurement value (meters walked) indicates improvement for this patient population.|Baseline to Week 48|All enrolled Population|||meters walked||Standard Deviation|Mean
1235604|NCT00617305|Secondary|Change From Baseline in Cardiac Output (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. An increase in measurement value (L/min) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated|||L/min||Standard Deviation|Mean
1235605|NCT00617305|Secondary|Change From Baseline in Mean Right Atrial Pressure (mRAP) (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated|||mmHg||Standard Deviation|Mean
1235606|NCT00617305|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated|||mmHg||Standard Deviation|Mean
1235607|NCT00617305|Primary|Change From Baseline in Pulmonary Vascular Resistance (PVR), Last Observation Carried Forward (LOCF)|The primary objective of this study is to evaluate the change from baseline in PVR, and other hemodynamic parameters, following the addition of ambrisentan to background PDE-5i therapy in subjects with PAH who have demonstrated a sub-optimal response to PDE-5i monotherapy. A decrease in measurement value (dynes sec/cm^5) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated|||dynes sec/cm^5||Standard Deviation|Mean
1235608|NCT00617279|Secondary|Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure|The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.|One month|The number of patients analyzed at 1 month does not equal the number of patients originally enrolled into the study, due to the fact that a number of enrolled patients did not have (or failed to attend) their 1 month follow-up visit prior to the termination of the study.|||scores on a scale||Standard Deviation|Mean
1235609|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|12 months||||Participants|||Number
1235610|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|6 months||||Participants|||Number
1235611|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through One Month Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|One month||||Participants|||Number
1235612|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through 12 Months|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|12 months||||Participants|||Number
1235613|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through 6 Months|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|6 months||||Participants|||Number
1235614|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through One Month Post-procedure|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|One month||||Participants|||Number
1235615|NCT00617279|Secondary|Number of Patients Surviving at 12 Months||12 months||||Participants|||Number
1235616|NCT00617279|Secondary|Number of Patients Surviving at 6 Months||6 months||||Participants|||Number
1235617|NCT00617279|Secondary|Number of Patients Surviving at One Month||One month||||Participants|||Number
1236821|NCT00608491|Secondary|Change in Blood Bicarbonate Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
1235621|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|6 months||||Participants|||Number
1235622|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|One month||||Participants|||Number
1235623|NCT00617279|Secondary|Number of Patients With Secondary Patency at 12 Months|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.|||Participants|||Number
1235624|NCT00617279|Secondary|Number of Patients With Secondary Patency at 6 Months|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.|||Participants|||Number
1235625|NCT00617279|Secondary|Number of Patients With Secondary Patency at One Month|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|One month|The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.|||Participants|||Number
1235626|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at 12 Months Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.|||Participants|||Number
1235627|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at 6 Months Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.|||Participants|||Number
1235628|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at One Month Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.|One month||||Participants|||Number
1235629|NCT00617279|Secondary|Number of Patients With Primary Patency at 6 Months Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.|||Participants|||Number
1235630|NCT00617279|Primary|Major Adverse Event Occurrences Through One Month Post-procedure|The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.|one month post-index procedure||||Events|||Number
1235631|NCT00617279|Secondary|Number of Patients With Primary Patency at One Month Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|One month|The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.|||Participants|||Number
1235632|NCT00617279|Primary|Number of Patients With Primary Patency at 12 Months Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that many enrolled patients did not have their 12 month follow-up visit prior to the termination of the study.|||Participants|||Number
1235633|NCT00617240|Secondary|Incidence of Metabolic Syndrome|Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.|24 weeks||||participants|||Number
1235634|NCT00617240|Secondary|Change From Baseline to Week 24 in Triglycerides|In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels.|24 weeks|Only participants with complete data on triglyceride levels at both baseline and 24 weeks were utilized.|||mg/dl||Standard Error|Mean
1235635|NCT00617240|Secondary|Change From Baseline to Week 24 in Cholesterol Level|According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline.|24 weeks|Only participants with complete data on cholesterol levels at both baseline and 24 weeks were utilized.|||mg/dl||Standard Error|Mean
1235636|NCT00617240|Secondary|Change From Baseline to Week 24 in Insulin Level|Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.|24 weeks|Only participants with complete data on insulin levels at both baseline and 24 weeks were utilized.|||microIU/ml||Standard Error|Mean
1235637|NCT00617240|Primary|Change From Baseline to Week 24 in Fat Mass|Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.|24 weeks|Only participants with complete data on fat mass at both baseline and 24 weeks were utilized.|||kg||Standard Error|Mean
1235638|NCT00617240|Primary|Change From Baseline to Week 24 in Weight|Change in weight is calculated as 24 weeks weight minus the baseline weight.|24 weeks||||kg||Standard Error|Mean
1235639|NCT00617240|Primary|Change From Baseline to Week 24 in Body Mass Index (BMI)|Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.|0-24 weeks|All participants who took at least one dose of study treatment and had at least one post baseline assessment.|||kg/m^2||Standard Error|Mean
1235640|NCT00617201|Secondary|Retention|Trial retention- those who complete the 12 week dosing period|12-weeks|those completing the 12-week study after randomization|||days||Standard Error|Mean
1235641|NCT00617201|Primary|% Urine Samples Negative for Cocaine|Total % urine samples negative for benzoylecgonine over the 12-week trial|Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks|Intent-to-treat analysis included all subjects with missing urine sample counted as positive.|||percentage of positive urine samples|Urine samples||Number
1235642|NCT00617188|Secondary|Urine N-telopeptide Concentration|Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.|Baseline, 1 Month, 3 Months, 6 Months||||Units of Bone Collagen Equivalents/mmol||Full Range|Median
1235643|NCT00617188|Primary|Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.|Day 90||||Participants|||Number
1235644|NCT00617188|Secondary|Serum Skeletal-Specific Alkaline Phosphatase Concentration|Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.|Baseline, 1 Month, 3 Months, 6 Months||||Units/Liter||Full Range|Median
1235645|NCT00617188|Secondary|Mean Scores - Quality of Life Assessment|Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O)Version 1/23/07 - This is a relative quality of life assessment; 100 = Best, 0 = Worst. It was developed and validated with cancer patients and includes physical well being, social well being, emotional well being and relationship with doctor subscales and can be summed into one total quality of life score. It is a standardized scale which collects data (scores 1-4) from 47 questions. Answers are transformed into a number between 0-100. Mean was calculated by adding up the values of the scores and dividing by the number of scores.|Baseline, 3 Months Post Treatment, 6 Months Post Treatment||||Scores on a Scale||Full Range|Mean
1235646|NCT00617188|Secondary|Median Number of Days to Treatment Termination|Time is determined from first dose to termination due to all causes.|Up to 373 Days||||Days||Full Range|Median
1235647|NCT00617188|Secondary|Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)|Defined by the sum of Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=normalization of serum CA-125 level from 2 initially elevated samples, PR=>or=50% decrease in serum CA-125 level from 2 initially elevated samples, Progressive Disease (PD)=CA-125 two times the upper limit of normal on 2 occasions (if previously normalized) OR CA-125 two times nadir (lowest value) on 2 occasions if elevated at initiation of treatment, SD=not CR, PR or PD.|Day 90||||Participants|||Number
1235648|NCT00617175|Secondary|Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.||end of study|||||||
1235649|NCT00617175|Primary|For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.|"for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed.~The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times * 100."|From enrollment to study completion or exit whichever occured first|For the primary endpoint analysis, only patients with at least a device data record were considered.|||rate of therapies per 100 patient-years||95% Confidence Interval|Number
1235675|NCT00616967|Secondary|Standard Uptake Values as Measured by Baseline and Changes (Day 15) on FDG-PET|The standard uptake value used for the PET analysis was SULmax, which is the standard uptake value normalized for lean body mass.|Baseline and day 15|"Of the 17 responders from the primary outcome measure, 16 participants had PET data evaluable for analysis. Of the 45 non-responders from the primary outcome measure, 43 participants had PET data evaluable for analysis."|||percentage of change in SULmax||Full Range|Median
1235676|NCT00616967|Secondary|Clinical Complete Response (cCR) Rate||Time of breast cancer surgery|||||||
1235650|NCT00617123|Secondary|Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography|Individual fundus photography abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 48 (24 possible abnomalities per eye). Data are for the left and right eyes combined (score range: 0 to 48). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment as measured by fundus photogrpahy.|||score on a scale||Standard Error|Mean
1235651|NCT00617123|Secondary|Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT|Individual OCT abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 84 (42 possible abnormalities per eye). Data are for the left and right eyes combined (score range: 0 to 84). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment by OCT.|||score on a scale||Standard Error|Mean
1235652|NCT00617123|Secondary|Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT|Center foveal thickness measured by OCT was evaluated for a change from baseline in greater than 15 microns in either the left or right eye.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline center point thickness assessment by OCT.|||participants|||Number
1235653|NCT00617123|Secondary|Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline|Visual acuity was assessed in both eyes by best corrected visual acuity following standardized refraction. The best corrected visual acuity score is the number of letters on a standard visual acuity testing chart read correctly by a participant. A decrease in best corrected visual acuity score in the left and/or right eye indicates a worsening of vision.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline visual acuity score.|||participants|||Number
1235654|NCT00617123|Primary|Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)|Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).|Up to 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline vacuolation assessment.|||participants|||Number
1235655|NCT00617097|Secondary|Complications||end of study||||participants|||Number
1235656|NCT00617097|Secondary|Reported Symptoms|fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)|end of study (upon discharge from facility after procedure)||||participants|||Number
1235657|NCT00617097|Secondary|Visual Analogue Scale Regarding Satisfaction Level|100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)|end of study (prior to clinic discharge)||||mm||Standard Deviation|Mean
1235658|NCT00617097|Primary|Level of Pain During Specific Time Intervals Throughout D&C Procedure.|"100-mm Visual Analogue Scale (VAS) during specific time intervals of D&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain)~Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure."|Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure||||mm||Standard Deviation|Mean
1235659|NCT00617084|Secondary|In-Stent Percent Diameter Stenosis|In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory.|13 Months||||Percentage diameter stenosis||Standard Deviation|Mean
1235660|NCT00617084|Primary|Target Lesion Failure|Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.|12 months|Analysis per intention to treat|||percentage of participants|||Number
1235661|NCT00617058|Secondary|Percent Change in LDL||24 weeks||||percent change|||Number
1235662|NCT00617058|Secondary|Percent Change in HDL||24 weeks||||percent change|||Number
1235663|NCT00617058|Secondary|Percent Change in Glucose Levels||24 weeks||||percent change|||Number
1235664|NCT00617058|Primary|Percent Change in Weight||24 weeks||||percent change|||Number
1235665|NCT00617058|Secondary|Incidence of Metabolic Syndrome||24 weeks||||participants|||Number
1235666|NCT00617058|Secondary|Percent Change in Triglycerides||24 weeks||||percent change|||Number
1235667|NCT00617058|Secondary|Percent Change in Total Cholesterol||24 weeks||||percent change|||Number
1235668|NCT00617058|Secondary|Percent Change in Insulin Levels||24 weeks||||percent change|||Number
1235669|NCT00617058|Primary|Percent Change in Fat Mass||24 weeks||||percent change|||Number
1235670|NCT00617058|Primary|Absolute Change in Weight||24 weeks||||lbs.|||Number
1235671|NCT00617058|Primary|Percent Change in BMI||24 weeks|This research study only enrolled a single study participant before the entire research study was terminated due to the start of a larger, multi-site trial evaluating similar outcome measures.|||percent change|||Number
1235678|NCT00616967|Primary|Pathological Complete Response (pCR) Rate|The primary end point was pCR, defined as no viable invasive cancer in breast and axilla. All other cases were defined as non-pCR. The pCR rate was determined in each arm separately by performing an intent-to-treat (ITT) analysis of all randomized patients. Patients with unknown pCR status were considered non-responders. Computation of associated 90% confidence intervals did not account for the sequential design.|Time of breast cancer surgery|"The information for the primary populations for analysis are included (Placebo and Vorinostat arms). The initial run-in phase of 6 participants was conducted to confirm safety and dosing for the combination of vorinostat with chemotherapy only, and these data are not a part of our primary study analyses."|||participants|||Number
1235679|NCT00616941|Secondary|Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline|Radiographic imaging (computed tomography of the abdomen and pelvis) was obtained at Screening and every 2 months during the study, and at unscheduled time points if any clinical symptoms/examination findings warranted further evaluation or if serum CA-125 rose to > 70 U/mL (confirmed by repeat value). Subjects may have had more than 1 location of disease.|Screening and every 2 months up to Week 16|The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy assessment performed.|||Participants|||Count of Participants
1235680|NCT00616941|Secondary|Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline|Serum CA-125 was measured at Screening, Week 7, and Week 16. Stable CA-125 at baseline was < 35 U/mL (defined as CA-125 that had not doubled from the post chemotherapy nadir).|Screening, Week 7, and Week 16|The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy measurement performed.|||U/mL||Standard Deviation|Mean
1235681|NCT00616941|Secondary|Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16|NY-ESO-1-specific DTH was measured by skin tests at Screening and again at Week 16. NY-ESO-1 OLP4 (40 µg in 0.1 mL D5W) was injected intradermally, with DTH reactions read 48 hours after injection.|Screening and Week 16|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
1235682|NCT00616941|Secondary|Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline|Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. NY-ESO-1-specific CD8+ and CD4+ T-cell reactivity was measured by tetramer analysis (in human leukocyte antigen [HLA] 0201* patients). Interferon gamma (IFN-γ) release by T cells was measured by the enzyme-linked immunospot (ELISPOT) assay. A subject was considered to have experienced a T-cell response if IFN-γ spots were detectable (>50 spots) by ELISPOT of 50,000 CD8+ and CD4+ T cells following pre-sensitization with a pool of 20-mer OLP covering all of NY-ESO-1 and tested against Epstein-Barr virus-transformed B cells pulsed with 3 subpools of these peptides.|Screening and Weeks 4, 7, 10, 13, and 16|The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.|||Participants|||Count of Participants
1235683|NCT00616941|Secondary|Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline|Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. Specific antibodies against NY-ESO-1 were measured by enzyme-linked immunosorbent assay (ELISA).|Screening and Weeks 4, 7, 10, 13, and 16|The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.|||Participants|||Count of Participants
1235684|NCT00616941|Primary|Overview of Treatment-emergent Adverse Events (TEAEs)|Analysis of TEAEs reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 3 weeks after the last dose of study treatment.|Continuously for up to 16 weeks|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
1235685|NCT00616928|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays|Titers were expressed as Geometric Mean Titers (GMTs).|At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.|||Titers||95% Confidence Interval|Geometric Mean
1235686|NCT00616928|Secondary|Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.|Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.|At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.|||Subjects|||Number
1235687|NCT00616928|Secondary|Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.|At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
1235688|NCT00616928|Secondary|Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)||At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6|||Subjects|||Number
1235740|NCT00616421|Secondary|Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.|day 1 to study termination (day 240)|The analysis was performed on safety population. Only groups receiving 1 dose vaccine are reported.|||Percentage of Subjects|||Number
1235689|NCT00616928|Secondary|Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.|At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6|||Subjects|||Number
1235690|NCT00616928|Secondary|Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10||At Month 6 (Day 182) post Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6|||Subjects|||Number
1235691|NCT00616928|Secondary|Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10||At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.|||Subjects|||Number
1235692|NCT00616928|Primary|Number of Subjects With Medically Attended Events (MAEs)||From Day 0 through Day 182 and through Day 364.||||Subjects|||Number
1235693|NCT00616928|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 through Day 182 and through Day 379.||||Subjects|||Number
1235694|NCT00616928|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)||||Subjects|||Number
1235695|NCT00616928|Primary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration|The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.|||Subjects|||Number
1235696|NCT00616928|Primary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration|The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.|||Subjects|||Number
1235697|NCT00616928|Primary|Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.|At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.|||Subjects|||Number
1235698|NCT00616928|Primary|Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.|At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.|||Subjects|||Number
1235699|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)|Plasma BNP is a product from the heart that becomes elevated with an enlarged heart and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||ng/L||Standard Deviation|Mean
1235741|NCT00616421|Secondary|Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.|Study days 1 to 7|The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.|||Percenatage of subjects|||Number
1235700|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks|Plasma high sensitivity CRP is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||mg/L||Standard Deviation|Mean
1235701|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks|Plasma IL-6 is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||cm/sec||Standard Deviation|Mean
1235702|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks|Plasma troponin-t is a marker of heart damage and and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||mcg/L||Standard Deviation|Mean
1235703|NCT00616902|Secondary|Change From Baseline in Biological Marker Triiodothyronine (T3).|Plasma T3 is a circulating hormone that may have an effect on diastolic heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||nmol/L||Standard Deviation|Mean
1235704|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks|E-wave deceleration time is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.|||sec||Standard Deviation|Mean
1235705|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Peak E-wave Velocity to Lateral E-wave Velocity (E/E') Over 48 Weeks.|The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function.|Baseline, Week 24, and Week 48/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.|||cm/sec||Standard Deviation|Mean
1235706|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.|Isovolumetric relaxation time is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.|||sec||Standard Deviation|Mean
1235707|NCT00616902|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)|"Change from Baseline in left ventricular mass index (LVMI) over 48 weeks measured by cardiac MRI. The effects of paricalcitol injection on progression or regression of left ventricular hypertrophy (LVH) in participants with Stage 5 chronic kidney disease (CKD) on hemodialysis (HD) compared to placebo. Left Ventricular Mass is normalized to the participant's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7.~The primary comparison was between the 4 mcg paricalcitol injection and the placebo treatment groups in the change from baseline to Week 48."|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug and the Evaluable population (a subset of ITT population and consists of those participants who have completed Week 24 visit). None of the participants completed 24 or 48 weeks.|||g/m2.7||Standard Deviation|Mean
1235708|NCT00616902|Secondary|Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.|Mitral Annular relaxation velocity is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.|||cm/sec||Standard Deviation|Mean
1235753|NCT00616343|Primary|Tremor Severity|PI has left the institution and we are unable to accurately assess the data from the remaining records.|4 weeks|||||||
1235709|NCT00616772|Secondary|Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 6 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 6 or more segments matched the segments at baseline and at 2 years.|||mm/year||Standard Error|Mean
1235710|NCT00616772|Secondary|Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.|||mm/year||Standard Error|Mean
1235711|NCT00616772|Secondary|Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.|||mm/year||Standard Error|Mean
1235712|NCT00616772|Secondary|Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)|Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter.|||mm/year||Standard Error|Mean
1235713|NCT00616772|Primary|Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)|Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized participants who had both a baseline value and at least 1 postbaseline value for that parameter.|||mm/year||Standard Error|Mean
1235714|NCT00616759|Primary|Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index|WMS-III Auditory Delayed Index is a measure of memory functioning. The results given are the post-ECT testing results. A smaller number indicates less memory disturbance on this scale. The range of scores is between 0-140 with higher scores indicating better memory function.|Pre-tesing within 36 hours before first ECT; Post-testing within 36 hours of 6th ECT.|The measurements listed are post-ECT testing for both groups|||units on a scale||Standard Deviation|Mean
1235715|NCT00616759|Secondary|California Verbal Learning Test (CVLT)|CVLT consists of a number of individual subtests of various aspects of memory. Higher scores indicate better memory function.|Within one week pre-ECT and within 48 hours after the 6th ECT|||||||
1235716|NCT00616655|Secondary|Change From Baseline Epworth Sleepiness Scale (ESS)|ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
1235717|NCT00616655|Secondary|Change From Baseline Sheehan Disability Scale (SDS)|The SDS was completed by the subject and captured the subject’s level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
1235718|NCT00616655|Secondary|Change From Baseline Insomnia Severity Index (ISI) Total Score|The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.|Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
1235719|NCT00616655|Secondary|Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form|The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum [item 1... item 14]-14)/(70-14 ) *100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
1235720|NCT00616655|Secondary|Hamilton Anxiety Scale (HAM-A) Remission|"The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less.~The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms."|Week 2, 4, 6, 8 based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||participants|||Number
1235721|NCT00616655|Secondary|Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response|"The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score.~The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms."|Week 2, 4, 6, 8|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||participants|||Number
1235722|NCT00616655|Secondary|Clinical Global Impression- Improvement (CGI-I)|"CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, Compared to his/her condition at Visit 2, how much has he/she changed? The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement."|Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
1235723|NCT00616655|Secondary|Change From Baseline in Clinician Global Impression of Severity (CGI-S)|"The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, Considering your total clinical experience with this particular population, how anxious is the subject at this time? The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity."|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
1235724|NCT00616655|Secondary|Change in Individual Item Scores on HAM-A|The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.|Baseline, Weeks 2, 4, 6, 8|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
1235725|NCT00616655|Secondary|Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)|The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.|Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||unit on a scale||Standard Deviation|Mean
1235726|NCT00616655|Primary|Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater|THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.|Baseline to Week 8|ITT Population: /The ITT population will include all randomized subjects who received at least one does of study medication during the double-blind period.|||Units on a scale||Standard Deviation|Mean
1235727|NCT00616642|Primary|Efficacy of Rosiglitazone Maleate on Cushing Disease|Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.|12 months|No data was analyzed for this outcome measure as there was insufficient data to perform analysis.||||||
1235728|NCT00616629|Secondary|Number of Patients Who Had at Least One AE|Number of patients|During active treatment period||||Participants|||Number
1235729|NCT00616629|Secondary|AUC Total of AZD1305 (Umol*h/L)|A total of 13 scheduled PK samples for each patient during and after infusion|Based on PK samples during and after infusion||||umol*h/L||Full Range|Mean
1235730|NCT00616629|Secondary|Cmax Observed for AZD1305|A total of 13 scheduled PK samples for each patient during and after infusion|During and after infusion||||umol/L||Full Range|Mean
1235731|NCT00616629|Secondary|QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia’ Formula =QT/RR1/3 Interval in Seconds)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona||||ms||Full Range|Mean
1235732|NCT00616629|Secondary|VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product||||ms||Full Range|Mean
1235733|NCT00616629|Secondary|RAERP (Right Atrial Effective Refractory Period)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product||||ms||Full Range|Mean
1235734|NCT00616629|Primary|LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product||||ms||Full Range|Mean
1235735|NCT00616603|Primary|Duration of Sciatic Nerve Block|Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores|from the time the block was placed up to 24 hours|PI left the institution and no analysis completed due to questionable data integrity||||||
1235736|NCT00616577|Primary|Usage of Pain Medications||Over 24 hours|PI left institution and records cannot be located.||||||
1235737|NCT00616434|Secondary|Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8|The SCCAI measures disease activity as defined by both participants and examiners and includes the following 13 items: general well-being, abdominal pain, bowel frequency, stool consistency, bleeding, anorexia, nausea or vomiting, abdominal tenderness, extra-intestinal complications (eye, mouth, joint, skin), temperature, sigmoidoscopic assessment, nocturnal bowel movements, and urgency of defecation. Scores range from 0 to 19 points, and scores <2.5 have been shown to correlate with Patient-Defined Remission, and a decrease of >1.5 points from Baseline correlates with Patient-Defined Significant Improvement. Baseline is defined as the mean of the screening and visit 1 scores.|Baseline and Week 8|Intent-to-treat (ITT): Defined as all randomized participants who received at least one dose of study treatment for whom a baseline SCCAI ≥ 3 was available.|||percentage of participants|||Number
1235738|NCT00616434|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE, can therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AE’s were analyzed based on the principle of treatment emergence. An AE was regarded as treatment-emergent if it was not present prior to receiving the first injection but subsequently appeared, or if it was present prior to receiving the first injection and subsequently worsened in severity.|Up to 16 weeks|Safety Population; participants who were randomized and received at least one dose of study treatment.|||participants|||Number
1235739|NCT00616434|Primary|Percentage of Participants With a Clinical Response|Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.|Baseline and Week 8|Intent-to-treat (ITT): Defined as all randomized participants who received at least one dose of study treatment for whom a baseline measure was available.|||percentage of participants|||Number
1235754|NCT00616239|Secondary|Improvement of Melasma Based on MASI Scores, Melasma Severity Assessment, and Physician and Patient Global Improvement Compared With the Opposite Side.||14 weeks|||||||
1235742|NCT00616421|Secondary|Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.|Study days 1 to 7|The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.|||Percentages of subjects|||Number
1235743|NCT00616421|Secondary|GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y.~ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1235744|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
1235745|NCT00616421|Secondary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
1235746|NCT00616421|Secondary|Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.|The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1235747|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.|The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
1235748|NCT00616421|Secondary|Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.|The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1235749|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
1235750|NCT00616421|Primary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
1235751|NCT00616421|Secondary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percenatage of subjects||95% Confidence Interval|Number
1235752|NCT00616421|Primary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
1235756|NCT00616200|Secondary|Sickness Impact Profile|Units of measurement on the Sickness Impact Profile were ordinal rated scored. Information on scoring use and interpretation of the Sickness Impact Profile, readers are encouraged to read Bergner et. al. 1981 - Bergner, M., Bobbit, R.A., Carter, W.B. et all (1981) the Sickness Impact Profile: Development and final revision of a health status measure. Medical Care, 19:787-805 The SIP measures sickness-related dysfunction based on behavior in order to provide a measure of health status that will aid in assessing the outcome of health care services.|At the end of four week VLCD|The scoring range is from no impairment with a score of 0, to significant impairment, with 5. Changes in score of 3.5 are considered clinically significant.|||Scores on a scale||Standard Deviation|Mean
1235757|NCT00616200|Secondary|Impact of Very Low Carbohydrate Diet on Stool Frequency|Stool Frequency was measured as number of stools per day|6 Weeks|Analysis was per protocol analysis|||Stools Per day||Standard Deviation|Mean
1235758|NCT00616200|Primary|"Number of Subjects Reporting Adequate Relief From IBS Symptoms for the Previous Week. Adequate Relief Was a True/False Item."|"Adequate relief was measured as the primary endpoint via a single item Adequate Relief Question asking Over the past week have you had adequate relief of your symptom experience. Higher scores represent greater levels of adequate relief over the week prior to the assessment. Participants completed this 1-item questionnaire at the end of each of weeks of the study, assessing whether they had adequate relief of their IBS symptoms for the week.~A responder was defined as reporting adequate relief in at least 2 of the 4 weeks on the VLCD."|At the end of each of 6 study weeks||||Participants|||Number
1235759|NCT00616122|Secondary|Correlation of Outcome Measures With Possible Surrogate Markers Including Serial Measurements of Circulating Tumor Cells and Circulating Endothelial Cells||until disease progression up to 13 months post treatment|||||||
1235760|NCT00616122|Secondary|Duration of Response|duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer).|until disease progression up to 13 months post treatment|A partial response was only reported for one patient, while a complete response was not recorded for any patients.|||weeks|||Number
1235761|NCT00616122|Secondary|Response|"Per Response Evaluation Criteria in Solid Tumors (RECIST):~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer)."|until disease progression up to 13 months post treatment||||participants|||Number
1235762|NCT00616122|Primary|PFS Greater Than or Equal to 12 Weeks (Phase II)|"Per Response Evaluation Criteria in Solid Tumors (RECIST):~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer)."|12 weeks|Patients who received either 25mg or 37.5mg of sunitinib and were not removed from study due to voluntary withdrawal or POD prior to receiving combination sunitinib and metronomic CM chemotherapy.|||participants|||Number
1235763|NCT00616122|Primary|Maximum Tolerated Dose (Phase I)|"Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level.~Dose limiting toxicity (DLT):~≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days~grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 ºC or 3 readings of oral temperature > 38.0 ºC in a 24 hour period)~≥ grade 3 thrombocytopenia~≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment.~Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity."|8 weeks||||mg|||Number
1235764|NCT00616109|Secondary|Number of Patients That Discontinue Drug Due to Toxicity|"Tolerability of Sunitinib will be evaluated by looking at the number of participants who discontinue drug due to toxicity. Toxicity was graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v.3.0.~In the event of any CTC, version 3.0 drug-related grade 3 or 4 non-hematologic or grade 4 hematologic adverse event(s), drug should be held until the toxicity resolves to < grade 1 and then the drug should be restarted at a one dose-level reduction.~Recovery to acceptable levels of toxicity must occur within 4 weeks to allow continuation in the study.~No more than 2 dose reductions are permitted for any patient. If further dose reduction is required, the patient must be removed from the study."|20 weeks|All patients who received sunitinib maintenance therapy were evaluable for toxicity and tolerability analysis.|||participants|||Number
1236160|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 230 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1235765|NCT00616109|Secondary|Percent of Patients With an Objective Response|Scans were performed every 2 cycles to evaluate for response/progression. Response was assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Patients would be considered to have an objective response if they experience CR (Complete Response - Disappearance of all clinical and radiological evidence of target lesions and/or non-target lesions) or PR (Partial Response - A 30% or greater decrease in the sum of LD of all lesions in reference to the baseline sum LD).|12 weeks (2 cycles)|Patients who received at least 2 cycles of study therapy (maintenance sunitinib)|||percentage of participants|||Number
1235766|NCT00616109|Secondary|Median Overall Survival|Survival will be defined as the time from the first day of therapy to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. Survival for induction therapy will be calculated from day 1 of first cycle of chemotherapy. Survival for post-induction therapy will be calculated from the date the patient starts sunitinib.|up to 4 months post treatment|15 participants in Sunitinib maintenance therapy (main study) were enrolled and were evaluable for this outcome measure. Although 16 patients were enrolled, one patient opted to discontinue therapy, refused further follow-up, and was therefore censored from survival analysis.|||months||95% Confidence Interval|Median
1235767|NCT00616109|Primary|Progression Free Survival Rate|The proportion of patients who are progression-free at 4 months after starting sunitinib.|4 Months Post Treatment|All 16 patients enrolled received a median of 4 weeks sunitinib maintenance therapy. 1 patient who discontinued requested no follow up and was censored from survival analysis. All survival endpoints were analyzed using the Kaplan-Meier method (Kaplan El, Meier P, Non-parametric Estimation from Incomplete Observations, J Am Stat Association, 1958)|||percentage of patients with PFS||95% Confidence Interval|Number
1235768|NCT00616018|Secondary|Alanine Aminotransferase (ALT)|ALT was measured at Day 0, 4, 7, 9, 11, and 14.|Day 0, 4, 7, 9, 11, and 14.|Analysis is based upon the 24 subjects who completed all study visits.|||IU/L||Standard Deviation|Mean
1235769|NCT00616018|Primary|Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts|Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.|Day 0, 4, 7, 9, 11, and 14.|Analysis is based upon the 24 subjects who completed all study visits.|||nmol/mL||Standard Deviation|Mean
1235770|NCT00615992|Secondary|Global Assessment of Tolerability by Physician|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||Participants|||Number
1235771|NCT00615992|Secondary|Global Assessment of Efficacy by Physician|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||Participants|||Number
1235772|NCT00615992|Secondary|Global Assessment of Tolerability by Patient|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||Participants|||Number
1235773|NCT00615992|Secondary|Global Assessment of Efficacy by Patient|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||Participants|||Number
1235774|NCT00615992|Secondary|Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva|The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||points on a scale||Standard Deviation|Mean
1235775|NCT00615992|Primary|Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva|The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||points on a scale||Standard Deviation|Mean
1235776|NCT00615927|Secondary|Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas|The number of patients experiencing any serious adverse event or other (non-serious) adverse event during the study participation.|156 weeks||||participants|||Number
1235777|NCT00615927|Secondary|Objective Response Rate|Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.|156 weeks||||participants|||Number
1235778|NCT00615927|Secondary|Median Overall Survival (OS)|Time in weeks from the start of cycle 1 to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in weeks from the start of cycle 1 to date of death due to any cause, assessed up to 156 weeks|Median overall survival was not estimable for either arm as not enough events of death occurred|||weeks||95% Confidence Interval|Median
1235779|NCT00615927|Secondary|Median Progression-free Survival|Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 156 weeks||||weeks||95% Confidence Interval|Median
1235780|NCT00615927|Primary|12-month Progression Free Survival (PFS)|Percentage of participants surviving twelve months from the start of cycle 1 without progression of disease. PFS was defined as the time from the cycle 1 start date to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|12 months||||percentage of participants||95% Confidence Interval|Number
1235781|NCT00615914|Primary|Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.|during 18 months|Patients excluded from 1581 patients were: 15 who had no visit since the first prescription, 2 for no treatment, 10 patients who were irregularly enrolled patients (exclusion from analysis according to regulatory requirement) and 1 patient that had no safety data available. As a result, there were 1553 patients in the safety analysis set.|||percentage of participants|||Number
1235782|NCT00615914|Secondary|Change From Baseline in Modified Hoehn & Yahr Rating Scale|A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).|Baseline and at 18 months (or at the time of discontinuation)|The number of patients from the efficacy analysis set (1527) who had the assessment of Modified Hoehn & Yahr rating scale at baseline and at or after 18 months of treatment or at the time of discontinuation (1430).|||Unit on a scale||Standard Deviation|Mean
1235783|NCT00615914|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.|Baseline and at 18 months (or at the time of discontinuation)|The number of patients from the efficacy analysis set (1527) who had the assessment of UPDRS Part III total score at baseline and at or after 18 months of treatment or at the time of discontinuation (1356).|||Unit on a scale||Standard Deviation|Mean
1235784|NCT00615914|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|18 months|A total of 26 patients were excluded from 1553 patients (Administration to patients who did not suffer from PD: 20, No efficacy data available: 6). As a result, 1527 patients included to the efficacy analysis set.|||Participants|||Number
1235785|NCT00615901|Primary|The Number of Patients Who Completed 8 Cycles.|the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.|2 years||||participants|||Number
1235786|NCT00615836|Secondary|Participants With Treatment-Emergent Adverse Events (AEs)|"An AE was any untoward medical occurrence that did not necessarily have a causal relationship with the study drug. An adverse drug reaction (ADR) was an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the study drug.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the patient's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. The intensity of an AE was defined as severe if it resulted in the inability to work or perform usual activities."|From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).|Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure; therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.|||participants|||Number
1235787|NCT00615836|Secondary|Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score|"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Physical Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
1235788|NCT00615836|Secondary|Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score|"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Mental Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
1235795|NCT00615836|Secondary|Change From Baseline in Total Sleep Time|"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the total sleep time was calculated and averaged for the 3 days. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||minutes||Standard Deviation|Mean
1235789|NCT00615836|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score|"The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The 19 individual items are scored on an evenly weighted 0 to 3 scale and generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging from 0 to 21. Higher numbers indicate greater sleep disturbance.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
1235790|NCT00615836|Secondary|Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The global QoL question is scored on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
1235791|NCT00615836|Secondary|Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The sleep/energy domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
1235792|NCT00615836|Secondary|Change From Baseline in NQoL Bother/Concern Domain Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The bother/concern domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
1235793|NCT00615836|Secondary|Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question (which is not included in the overall score). The 12 core items are scored on a 0 to 4 scale, and the overall score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
1235794|NCT00615836|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score|"The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. To assess nighttime urination bother, participants were asked to rate the degree of bother of nighttime urination by answering the question “Night time urination: How much does this bother you?” on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate greater bother.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
1235836|NCT00615108|Primary|Percentage of Patients Achieving Blood Pressure (BP) Control|BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.|01-Dec-2006 to 31-Dec-2008|Subjects include those who took 20mg, 40mg, 80mg and unknown dosage|||Percentage of Participants|||Number
1236822|NCT00608491|Secondary|Change in Blood Urea Nitrogen/Urea||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1235796|NCT00615836|Primary|Change From Baseline in Initial Period of Undisturbed Sleep|"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||minutes||Standard Deviation|Mean
1235797|NCT00615836|Primary|Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids|"Percentage of participants with >33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||percentage of participants|||Number
1235798|NCT00615836|Primary|Change From Baseline in Mean Number of Nocturnal Voids|"Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||nocturnal voids||Standard Deviation|Mean
1235799|NCT00615719|Primary|The Presence of Acute Coronary Syndromes(ACS).|The presence of ACS was determined by either cardiac angiography, nuclear perfusion imaging or a clinical course deemed consistent with ACS by final chart review. The number of participants with ACS was determined.|During the presenting illness, usually within two to three days.|Only 30 evaluable patients in study powered for 80 patients.|||participants|||Number
1235800|NCT00615589|Secondary|Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression|Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.|3 years||||percentage of deaths||95% Confidence Interval|Number
1235801|NCT00615589|Secondary|Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)|"Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed.~Acute GVHD Grading:~Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus"|100 days, 2 years||||percentage of participants||95% Confidence Interval|Number
1235802|NCT00615589|Secondary|Percentage of Patients With Treatment Related Mortality (TRM)||100 days, one-year||||percentage of patients||95% Confidence Interval|Number
1235803|NCT00615589|Secondary|The Percentage of Patients Free From Progression at 1 Year|"One of the secondary outcomes that will be measured is progression free survival at 1 Year.~Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia."|1 Year||||percentage of patients||95% Confidence Interval|Number
1235804|NCT00615589|Primary|The Percentage of Patients Alive 1 Year Post Transplant|The primary objective is overall survival, one year from the time of transplant.|1 Year||||percentage of patients||95% Confidence Interval|Number
1235805|NCT00615550|Secondary|Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams|Assessment of birth weight < 1500 grams or < 2500 grams|date of delivery|Available birth weight.|||participants|||Number
1235806|NCT00615550|Secondary|Number of Neonates Who Died.||Delivery to 28 days|All infants with a known delivery date and status.|||participants|||Number
1235807|NCT00615550|Secondary|Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.|Number of participants at <=27 6/7 , <=34 6/7, and <36 6/7.|Gestational Age at Delivery|Intent to Treat|||participants|||Number
1235808|NCT00615550|Secondary|Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)|"Each infant is scored based on the 7 morbidity and mortality events above:~0= no morbidity event~1 morbidity event~2 morbidity events~3 or more morbidity events~mortality"|Delivery Hospitalization (1-212 days)||||participants|||Number
1235809|NCT00615550|Primary|Number of Participants With Birth <=32 6/7 Weeks Gestation.||9 to 13 weeks|Intent to Treat|||participants|||Number
1235810|NCT00615472|Primary|Number of Participants With Improved Postoperative Delirium and Cognitive and Motor Changes|A battery/Questionnaire of neuropsych examinations is given to the subjects to measure improvement based on change of scores and standard deviation. The battery consists of questions regarding delirium, cognitive and motor changes and yields a combination assessment of all 3 elements.|Four months||||participants|||Number
1235837|NCT00615069|Secondary|Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications||Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)||||Participants|||Number
1235838|NCT00615069|Primary|Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year||Treatment through 1 year post-procedure (365 days)||||days||Standard Error|Mean
1235811|NCT00615459|Secondary|Peak FEV1 During 4 Hours Post Morning Dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|Day 1 (from 0 to 4 hours post morning dose)|The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug.|||Liters||Standard Error|Least Squares Mean
1235812|NCT00615459|Primary|24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period|The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug. Patients were analyzed according to treatment they received.|||Liters||Standard Error|Least Squares Mean
1235813|NCT00615433|Secondary|CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale, where a higher score is associated with greater illness severity.|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||scale||95% Confidence Interval|Least Squares Mean
1235814|NCT00615433|Primary|Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.|The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.|Baseline and 6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1235815|NCT00615290|Secondary|Patient Self Perception of the New Treatment|"Visual analogue scale range from 0 not at all satisfied to 100 extremely satisfied"|Day 0, month 3 and month 6|All enrolled patients|||millimeter||Standard Deviation|Mean
1235816|NCT00615290|Secondary|CD4 Count at 3 Months||3 months after inclusion|All enrolled patients with data at 3 months|||cells/cubic millimeter||Inter-Quartile Range|Median
1235817|NCT00615290|Secondary|Viral Load Response at 3 Months|"Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL."|3 months after inclusion|All enrolled patients with data at 3 months|||copies/mL||Inter-Quartile Range|Median
1235818|NCT00615290|Secondary|Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL|Number of patients with a viral load < 50 copies/mL after 3 months of treatment|3 months after inclusion|All enrolled patients with data at 3 months|||participants|||Number
1235819|NCT00615290|Secondary|Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL|Number of patients with a viral load < 400 copies/mL after 3 months of treatment|3 months after inclusion|All enrolled patients with data at 3 months|||participants|||Number
1235820|NCT00615290|Secondary|CD4 Count at 1 Month||1 month after inclusion|All enrolled patients with data at 1 month|||cells/cubic millimeter||Inter-Quartile Range|Median
1235821|NCT00615290|Secondary|Viral Load Response at 1 Month|"Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL."|1 month after inclusion|All enrolled patients with data at 1 month|||copies/mL||Inter-Quartile Range|Median
1235822|NCT00615290|Secondary|Evaluation of Early Virological Response|Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10|1 month after inclusion|All enrolled patients with data at 1 month|||participants|||Number
1235823|NCT00615290|Primary|Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3|The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3|6 months after inclusion|All enrolled patients with data at 6 months|||participants|||Number
1235824|NCT00615264|Secondary|Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months|Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 Months|Modified Intent to Treat (MITT) Population|||nmol*minute/L||Standard Error|Mean
1235825|NCT00615264|Primary|Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months|Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 months|Modified Intent to Treat (MITT) Population - all randomized patients who received at least one dose of study medication and who entered the study according to the definition of the target population, as defined by the inclusion and exclusion criteria in the study protocol|||nmol*minute/L||Standard Error|Mean
1236823|NCT00608491|Secondary|Change in Blood Potassium Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
1235826|NCT00615199|Secondary|Time to First Response 100|Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.|||days||95% Confidence Interval|Median
1235827|NCT00615199|Secondary|Time to First Response 70|Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 , higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.|||days||95% Confidence Interval|Median
1235828|NCT00615199|Secondary|Time to First Clinical Remission|Clinical remission=CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.|||days||95% Confidence Interval|Median
1235829|NCT00615199|Secondary|Number of Participants With Clinical Response 100 at Week 4|Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.|||participants|||Number
1235830|NCT00615199|Secondary|Number of Participants Achieving Clinical Remission at Week 4|Clinical remission=CDAI at Week 4 less than (<) 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.|||participants|||Number
1235831|NCT00615199|Secondary|Number of Participants With Clinical Response 70 at Week 1 and 2|Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1, 2|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least (>=)1 week of dosing and had >=1 valid CDAI score during active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside visit window. ‘n’=participants evaluable at given time point for each group.|||participants|||Number
1235832|NCT00615199|Primary|Number of Participants With Clinical Response 70 at Week 4|Clinical response 70: defined as a reduction in Crohn’s Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|Full Analysis Set (FAS): all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.|||participants|||Number
1235833|NCT00615108|Secondary|Overall Assessment by Attending Physicians|"Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:~4: Outstanding 3: Very satisfactory 2: Satisfactory~1: Marginal 0: Not satisfactory"|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage|||Percentage of Participants|||Number
1235834|NCT00615108|Secondary|Overall Assessment by Patients|"Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:~4: Outstanding 3: Very satisfactory 2: Satisfactory~1: Marginal 0: Not satisfactory"|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage.|||Percentage of Participants|||Number
1235835|NCT00615108|Secondary|Percentage of Patients Achieving BP Response|Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks.|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage.|||percentage of participants|||Number
1236161|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 170 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1235839|NCT00615056|Secondary|Change From Baseline in MDASI–D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal|Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.|Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal|ITT population. Here 'N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||Units on a Scale||95% Confidence Interval|Mean
1235840|NCT00615056|Secondary|Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI–D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal|Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.|Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal|ITT population. Here 'N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||Units on a Scale||95% Confidence Interval|Mean
1235841|NCT00615056|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).|||Months||95% Confidence Interval|Median
1235842|NCT00615056|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1235843|NCT00615056|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or up to 1 year after the randomization of last participant|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1235844|NCT00615056|Primary|Progression Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1235845|NCT00615030|Secondary|Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons|Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. On the morning and evening of Day 15 trough FEV1 (i.e. mean of measurements performed 23 h 10 min and 23 h 45 min post-dose) were assessed. An analysis of covariance (ANCOVA) model was used with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|After 14 days of dosing|The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means.|||Liters||Standard Error|Least Squares Mean
1235846|NCT00615030|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo|"Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate.~The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period."|After 14 days of treatment|The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means. This analysis included all patients who received indacaterol in the evening or placebo in their assigned treatment sequence.|||Liters||Standard Error|Least Squares Mean
1235847|NCT00615017|Secondary|Number of Patients Below Tumour Necrosis Factor (TNF)-Alpha Limit of Quantification (LOQ) at 24 Hours (n< LOQ)|Number of patients below tumour necrosis factor (TNF)-alpha limit of quantification (LOQ) at 24 hours (n< LOQ) measured by ELISA (LOQ = 1.3 pg/mL). Safety analysis set (ie all patients who started study drug infusion).|24 hours|Participants analyzed relates to the number of evaluable patients at the specified time point.|||Participants|||Number
1235848|NCT00615017|Secondary|Tmax of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|tmax of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.|||Hours||Full Range|Median
1235849|NCT00615017|Secondary|Cinf of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|Cinf of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg/mL||Full Range|Geometric Mean
1235850|NCT00615017|Secondary|AUC(0-12) of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|AUC(0-12) of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg.h/mL||Full Range|Geometric Mean
1235851|NCT00615017|Secondary|Time to Reach Cinf (Tmax) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|tmax of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||Hours||Full Range|Median
1235852|NCT00615017|Secondary|Maximum (End of Infusion) Serum Concentration (Cinf) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3,4 and 5)|Cinf of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg/mL||Full Range|Geometric Mean
1235853|NCT00615017|Secondary|AUC(0-12) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|AUC(0-12) of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg.h/mL||Full Range|Geometric Mean
1235854|NCT00615017|Secondary|Total Apparent Clearance (CL) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|CL of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||mL/min/kg||Full Range|Mean
1235855|NCT00615017|Secondary|Terminal Half-life (t1/2) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|t1/2 of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||Hours||Full Range|Mean
1235856|NCT00615017|Secondary|Area Under the Serum Concentration-time Curve From 0 to 12 Hours (AUC(0-12)) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|AUC(0-12) for single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, and 12h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg.h/mL||Full Range|Geometric Mean
1235857|NCT00615017|Secondary|Change From Baseline in Sequential Organ Failure Assessment (SOFA) Scores|Change in SOFA (Sequential Organ Failure Assessment) scores from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. The SOFA score is out of a maximum of 24 (units on a scale 0 to 24). The higher the score, the worse the organ system functioning. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.|||units on a scale (0 to 24)||Full Range|Mean
1235858|NCT00615017|Secondary|28-Day Mortality|The number of patients who had died at Day 28. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)||||Participants|||Number
1235859|NCT00615017|Primary|Change From Baseline in Body Weight|Change in body weight from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.|||kg||Full Range|Mean
1235860|NCT00615017|Primary|Change From Baseline in Calculated Mean Arterial Blood Pressure|Change in calculated mean arterial pressure from baseline (pre-infusion) to Day 14 [calculated as Day 14 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 14|Participants analyzed relates to the number of evaluable patients at the specified time point.|||mmHg||Full Range|Mean
1236824|NCT00608491|Secondary|Change in Blood Sodium Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
1235861|NCT00615017|Primary|Change From Baseline in QT With Fridericia Correction (QTcF), Where QT is Measured by ECG, and is the Time Interval Between the Start of the Q Wave and the End of the T Wave in the Heart's Electrical Cycle.|Change in QTcF from baseline (pre-infusion) to Day 1 (end of infusion) for Cohorts 1 and 2 [calculated as Day 1 mean minus baseline mean] and Day 5 (end of infusion) for Cohorts 3 to 5 and placebo [calculated as Day 5 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 1 (end of infusion) for Cohorts 1 and 2; Day 5 (end of infusion) for Cohorts 3 to 5 and placebo|Participants analyzed relates to the number of evaluable patients at the specified time point.|||msec||Full Range|Mean
1235862|NCT00615017|Primary|Change From Baseline in Troponin I|Change in troponin I values from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg/L||Full Range|Mean
1235863|NCT00615017|Primary|Change From Baseline in Prothrombin Time Values|Change in prothrombin time values from baseline (pre-infusion) to Day 7 [calculated as Day 7 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 7|Participants analyzed relates to the number of evaluable patients at the specified time point.|||sec||Full Range|Mean
1235864|NCT00615017|Primary|Change From Baseline in Platelet Count Values|Change in platelet count values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||10^9/L||Full Range|Mean
1235865|NCT00615017|Primary|Change From Baseline in White Blood Cell Values|Change in white blood cell values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||10^9 cells/L||Full Range|Mean
1235866|NCT00615017|Primary|Change From Baseline in Haemoglobin Values|Change in haemoglobin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||g/L||Full Range|Mean
1235867|NCT00615017|Primary|Change From Baseline in Bilirubin Values|Change in bilirubin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μmol/L||Full Range|Mean
1235868|NCT00615017|Primary|Change From Baseline in Aspartate Aminotransferase Values|Change in aspartate aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μkat/L||Full Range|Mean
1235869|NCT00615017|Primary|Change From Baseline in Alanine Aminotransferase Values|Change in alanine aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μkat/L||Full Range|Mean
1235870|NCT00615017|Primary|Change From Baseline in Creatinine Values|Change in creatinine values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μmol/L||Full Range|Mean
1235871|NCT00614991|Primary|CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||L/h||90% Confidence Interval|Mean
1235872|NCT00614991|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng•h/mL||90% Confidence Interval|Mean
1236003|NCT00614055|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The FAS included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
1235873|NCT00614991|Primary|Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID.|RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng/mL||90% Confidence Interval|Mean
1235874|NCT00614991|Primary|CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||L/H||90% Confidence Interval|Mean
1235875|NCT00614991|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||ng•h/mL||90% Confidence Interval|Mean
1235876|NCT00614991|Secondary|Number of Participants Who Experienced Adverse Events|"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:~RAL 400mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with RAL 400mg BID~FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID~FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004."|Day 0 through Day 49||||participants|||Number
1235877|NCT00614991|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||ng/mL||90% Confidence Interval|Mean
1235878|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mmol/L||Standard Error|Mean
1235879|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mmol/L||Standard Error|Mean
1236162|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 140 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1235880|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mmol/L||Standard Error|Mean
1235881|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mg/dL||Standard Error|Mean
1235882|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mg/dL||Standard Error|Mean
1235883|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mg/dL||Standard Error|Mean
1235884|NCT00614939|Secondary|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline , Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||Percent||Standard Error|Mean
1235885|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mmol/L||Standard Error|Mean
1235886|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mmol/L||Standard Error|Mean
1235887|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mmol/L||Standard Error|Mean
1235888|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mg/dL||Standard Error|Mean
1236019|NCT00613951|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). HbA1c values were missing for 2 subjects, hence did not contribute to the analysis|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1235889|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mg/dL||Standard Error|Mean
1235890|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mg/dL||Standard Error|Mean
1235891|NCT00614939|Primary|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline , Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||Percent||Standard Error|Mean
1235892|NCT00614926|Secondary|"Number of Impaired Scores on Neuropsychological (Brief) Test Battery"|This was an initial plan but the large majority of patients were too impaired (either anarthric or unable to use hands) to complete the tests we had selected so this outcome measure turned out to be unfeasible. Therefore, 0 participants were analyzed.|4 weeks||||participants|||Number
1235893|NCT00614926|Primary|"Participants Considered Responders (Scored 1 or 2) on Clinical Global Impressions Scale"|"The CGI is a standardized assessment tool widely used in clinical psychopharmacology trials as an outcome measure. Scores range from 1= very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5-7 = worse. We use it as a dichotomous measure with scores of 1 or 2 signifying responder and all the rest as non-responder using all available data including clinician judgement, and ratings scales."|4 weeks|Analysis was Intention to Treat (ITT) including Last-Observation-Carried-Forward (LOCF) as indicated. Proof of concept study so N was based on accrual feasibility.|||"participants considered responders"|||Number
1235894|NCT00614913|Primary|Median Survival Without Tumor Progression|Median time until disease progression or death|3 months|All participants|||months||95% Confidence Interval|Median
1235895|NCT00614913|Primary|3-year Survival Without Tumor Progression for Patients Within the Milan Criteria|Percent of participants alive and without tumor progression 3 years following treatment.|3 months|Participants that were within the Milan criteria|||percentage of participants|||Number
1235896|NCT00614874|Secondary|Forced Expiratory Volume in One Second (FEV1) Percent Predicted|Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.|patients were assessed at baseline and 12 weeks|Two subjects withdrew from the study in visit 3|||percent predicted||Standard Deviation|Mean
1235897|NCT00614874|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|FEV1 in liters|patients were assessed at baseline and 12 weeks|Two subjects withdrew from the study in visit 3|||Liters||Standard Deviation|Mean
1235898|NCT00614874|Secondary|Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion|Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.|patients were assessed at baseline and 12 weeks|2 patients withdrew from the study in visit 3|||parts per billion||Standard Deviation|Mean
1235899|NCT00614874|Primary|Methacholine Responsiveness as Assessed by PC20,|PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%|patients were assessed at baseline and at 12 weeks|3 subjects were not included in the final analysis due to missing data. Two subjects withdrew by visit 3. 1 had missing data at visit 2 due to equipment failure.|||mg/mL||Standard Deviation|Mean
1235900|NCT00614744|Secondary|Number of Infants With Neonatal Seizures, With and Without EEG Abnormalities||Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
1235901|NCT00614744|Secondary|Number of Infants With a DNR Order That Died||Birth to 18-22 months corrected gestational age|Only infants with DNR order|||Participants|||Count of Participants
1235902|NCT00614744|Secondary|Number of Infants With a DNR Order and Support is Withdrawn||Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
1235903|NCT00614744|Secondary|Number of Infants With a DNR Order||Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
1235904|NCT00614744|Secondary|Number of Infants With Non-CNS Organ System Dysfunction|Based on observing presence of organ dysfunction on at least one of the following: Pulmonary (Meconium aspiration syndrome, PPHN, Pulmonary hemorrhage, Pneumonia, Chronic lung disease, ECMO, INO), Cardiovascular (Cardiomegaly, Cardiac failure, Cardiac dysfunction (by echo), Cardiac ischemia (by EKG and/or increased enzymes), Hypotension, Arrhythmia), Renal (Oliguria, Anuria, Dialysis), Gastrointestinal (NEC, Hepatic dysfunction), Hematologic (DIC) and Metabolic (Hypoglycemia, Hypocalcemia, Hypomagnesemia)|Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
1235925|NCT00614614|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value|The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.|||Participants|||Count of Participants
1235905|NCT00614744|Secondary|Number of Infants With Any Disability Based on Level of Encephalopathy at Randomization|Mild disability will be defined by either a Bayley III cognitive score of 70-84 alone or a Bayley III cognitive score >= 85 and any of the following: presence of a GMF level 1 or 2OR seizure disorder or hearing loss. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 OR Gross Motor Functional (GMF) Level of 3-5 OR blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
1235906|NCT00614744|Secondary|Number of Infants With Mild, Moderate and Severe Disability|Mild disability will be defined by either a Bayley III cognitive score of 70-84 alone or a Bayley III cognitive score >= 85 and any of the following: presence of a GMF level 1 or 2 OR seizure disorder or hearing loss. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 OR Gross Motor Functional (GMF) Level of 3-5 OR blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues|||Participants|||Count of Participants
1235907|NCT00614744|Secondary|Number of Infants With Moderate and Severe Disability|Moderate disability will be defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 or Gross Motor Functional (GMF) Level of 3-5 or blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues|||Participants|||Count of Participants
1235908|NCT00614744|Secondary|Number of Deaths in the NICU and Following Discharge||Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues|||Participants|||Count of Participants
1235909|NCT00614744|Primary|Death or Moderate or Severe Disability|Severe disability was defined by any of the following: a Bayley III cognitive score < 70 or Gross Motor Functional (GMF) Level of 3-5 blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues|||Participants|||Count of Participants
1235910|NCT00614614|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.|||Participants|||Count of Participants
1235911|NCT00614614|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).|The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.|||Participants|||Count of Participants
1235912|NCT00614614|Secondary|Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day follow-up period (Day 0-30)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.|||Participants|||Count of Participants
1235913|NCT00614614|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During a 31-day follow-up period (Day 0-30)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.|||Participants|||Count of Participants
1235914|NCT00614614|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits|NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)|The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.|||Participants|||Count of Participants
1235960|NCT00614432|Primary|Differences is Intraoperative Blood Loss in Anticoagulated Versus Non-anticoagulated Women Receiving a Surgical Termination of Pregnancy.||Post procedure||||milliliters||Standard Deviation|Mean
1235915|NCT00614614|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits|NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.|||Participants|||Count of Participants
1235916|NCT00614614|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine|Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.|During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.|||Participants|||Count of Participants
1235917|NCT00614614|Secondary|Number of Subjects Reporting Any Rash|Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.|||Participants|||Count of Participants
1235918|NCT00614614|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase|Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.|||Participants|||Count of Participants
1235919|NCT00614614|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine|Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.|During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.|||Participants|||Count of Participants
1235920|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||titer||95% Confidence Interval|Geometric Mean
1235921|NCT00614614|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||Participants|||Count of Participants
1235922|NCT00614614|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group|The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.|||Participants|||Count of Participants
1235923|NCT00614614|Secondary|Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group|Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1235924|NCT00614614|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value|The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.|||Participants|||Count of Participants
1235961|NCT00614406|Primary|Menstrual Cycle Length|Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.|3 months|Intention to Treat (ITT)|||Days||Standard Deviation|Mean
1236033|NCT00613626|Secondary|Measure Overall Survival for Each Arm||24 months||||Months||95% Confidence Interval|Median
1235926|NCT00614614|Secondary|Anti-D and Anti-T Geometric Mean Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL).|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1235927|NCT00614614|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8|Prior to vaccination at 15-18 months of age (Month 13)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||Participants|||Count of Participants
1235928|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|Prior to vaccination at 15-18 months of age (Month 13)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||titer||95% Confidence Interval|Geometric Mean
1235929|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.|||titer||95% Confidence Interval|Geometric Mean
1235930|NCT00614614|Secondary|Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group|The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.|||Participants|||Count of Participants
1235931|NCT00614614|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.|||Participants|||Count of Participants
1235932|NCT00614614|Primary|Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group|Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on Nimenrix 2 and ActHIB- Infanrix Group.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1235933|NCT00614614|Primary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.|||Participants|||Count of Participants
1235934|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.|||titer||95% Confidence Interval|Geometric Mean
1235935|NCT00614614|Primary|Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group|The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. It was performed on the Nimenrix 2 and ActHIB- Infanrix Group.|||Participants|||Count of Participants
1235936|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||titer||95% Confidence Interval|Geometric Mean
1235937|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.|||titer||95% Confidence Interval|Geometric Mean
1235938|NCT00614614|Primary|Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||Participants|||Count of Participants
1235939|NCT00614614|Primary|Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.|||Participants|||Count of Participants
1235940|NCT00614575|Primary|Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.|for 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1235941|NCT00614575|Secondary|Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.|After 12 weeks or at the time of discontinuation|Efficacy Analysis Set|||units on a scale||Standard Deviation|Mean
1235942|NCT00614575|Secondary|Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score|Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set|||Unit on a scale||Standard Deviation|Mean
1235943|NCT00614575|Secondary|Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score|The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set|||Unit on a scale||Standard Deviation|Mean
1235944|NCT00614575|Secondary|Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set|||Unit on a scale||Standard Deviation|Mean
1235945|NCT00614575|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|for 12 weeks after initiation of the treatment|Efficacy analysis set|||participants|||Number
1235946|NCT00614523|Secondary|Annualized Rate of Patient-reported Bleeding Events|The number of bleeding events was obtained from the thrombocytopenia symptoms (Th-symptoms) survey. Patients reported spontaneous bleeding to have occurred 0, 1 or 2, 3 or 4, 5 or 6, or 7 or more times in the past week. The lower threshold of bleeding counts is used for conservative purposes (i.e., the “3” is used for the response option of “3 or 4 times”). Exposure adjusted event rate per 100 patient-years = number of events / patient-year * 100.|Test Treatment Period (Weeks 1-26)|The Patient Reported Outcomes (PRO) analysis set consists of patients in the full analysis set who also completed the baseline and at least one post-baseline assessment for any PRO measure.|||events per 100 patient-years||95% Confidence Interval|Mean
1235947|NCT00614523|Secondary|Kaplan-Meier Estimate of Survival at Month 12|Overall survival was calculated using Kaplan-Meier methods.|Month 12, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.|||percentage of participants||95% Confidence Interval|Number
1235948|NCT00614523|Secondary|Time to Death|Overall survival was calculated using Kaplan-Meier methods. For patients who discontinued early, additional information from the long term follow-up are added (closest available follow-up information up to 58 weeks).|From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.|||months||95% Confidence Interval|Median
1235949|NCT00614523|Secondary|Number of Participants Who Died||From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.|||participants|||Number
1236001|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||IU/L||Standard Deviation|Mean
1235950|NCT00614523|Secondary|Exposure-adjusted Total Duration of Platelet Hematologic Improvement (HI-P) in the Absence of Platelet Transfusions|Duration for participants who did not report HI-P during the period is 0. A platelet hematologic improvement (HI-P) is defined by an MDS International Working criteria as patients with a baseline platelet count of ≥ 20 x 10^9/L achieving an absolute increase of ≥ 30 x 10^9/L or increasing the platelet count to above 20 x 10^9/L and by at least 100% in patients with a baseline of < 20 x 10^9/L for at least 8 consecutive weeks. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint. The durations of HI-P are cumulative if more than one incidence occurred. Exposure adjusted event rate per 100 patient-weeks = total number of weeks / patient-weeks * 100.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||weeks per 100 patient-weeks||95% Confidence Interval|Mean
1235951|NCT00614523|Secondary|Number of Participants With Platelet Hematologic Improvement (HI-P)|Platelet Hematologic Improvemen defined by the international working group (IWG) as: an absolute increase in platelet count of ≥ 30 x 10^9/L for a patient starting with a platelet count of ≥ 20 x 10^9/L or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a patient that started with a platelet count < 20 x 10^9/L. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||Participants|||Number
1235952|NCT00614523|Secondary|Annualized Rate of Total Platelet Transfusion Units|The time from first dose of study drug to the last dose of 26-week test treatment period. A unit of platelets is defined as a single pack of pooled platelet-rich plasma comprised of 6 to 8 individual platelet concentrate packs (200 to 400 mL), a single pack of pooled buffy-coat concentrate, or 1 apheresis (single donor) concentrate. Exposure adjusted event rate per 100 patient-years = events / patient-years * 100.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized subjects|||units per 100 patient-years||95% Confidence Interval|Mean
1235953|NCT00614523|Secondary|Annualized Rate of Overall Bleeding Events|The time from first dose of study drug to the last dose of 26-week test treatment period. A bleeding event is defined as any bleeding event reported during the test treatment period. Bleeding events that continue for more than 7 days are counted as separate events every eighth day. Multiple events that arose from one organ system on one day are collapsed into one single event. Exposure adjusted event rate per 100 patient-years = events / patient-year * 100).|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||events per 100 patient-years||95% Confidence Interval|Mean
1235954|NCT00614523|Secondary|Annualized Rate of Platelet Transfusion Events|A discrete platelet transfusion is any number of platelet transfusion administered within a 3-day period. Transfusions administered more than 3 days apart are counted as separate events. Transfusion given in the absence of any bleeding, when platelet count is >10x10^9/L, is not counted as a platelet transfusion event. Events with start date between the first dose date and the last dose date of the test treatment period +7 days are included. Exposure adjusted event rate per 100 patient-years = (events / patient-years * 100). Patient Year = total patient years of exposure to investigational product during 26 weeks test treatment period.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||events per 100 patient-years||95% Confidence Interval|Mean
1235955|NCT00614523|Primary|Number of Clinically Significant Bleeding Events|A clinically significant bleeding event is defined as any bleeding event of grade ≥ 2 per the modified World Health Organization (WHO) bleeding scale: • Grade 0 = no bleeding • Grade 1 = petechia or mucosal or retinal bleeding not requiring intervention • Grade 2 = melena, hematemesis, hematuria, hemoptysis • Grade 3 = bleeding required red cell transfusion • Grade 4 = retinal bleeding with visual impairment • Grade 5 = non-fatal cerebral bleeding • Grade 6 = fatal cerebral bleeding • Grade 7 = fatal non-cerebral bleeding. Bleeding events that continue for more than 7 days were counted as separate events every eighth day. Multiple events that arose from one organ system on one day were collapsed into one single event. Bleeding events with a start date between the first dose date and the last dose date of the test treatment period+7 days are included.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||events|||Number
1235956|NCT00614484|Secondary|Treatment Related Toxicities.|"grade 3 or higher esophageal toxicity~Toxicity is categorized either early or late phase.~Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter"|Monthly for duration of participant lifespan. Average lifespan 1-2 years||||participants|||Number
1235957|NCT00614484|Primary|Overall Survival.|Median survival time following treatment.|Monthly for duration of participant lifespan. Average lifespan 1-2 years||||Months||95% Confidence Interval|Median
1235958|NCT00614458|Primary|A Change in the Number of HIV Infected Cells.|A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment.|20 weeks|All participants analyzed per protocol|||infected cells /million cells||95% Confidence Interval|Median
1235959|NCT00614445|Primary|Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).|The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rated from 3 (no symptoms) to 15 (most severe).|Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)|Planned: Approximately 280 subjects (140 subjects per treatment group) were to be enrolled to achieve 200 evaluable subjects. Analyzed: 280 enrolled subjects [261 subjects in the intent-to-treat safety (ITT-S) population; 256 subjects in the intent-to-treat efficacy (ITT-E) population].|||PUQE Score||95% Confidence Interval|Mean
1235962|NCT00614393|Secondary|Overall Response Rate (ORR) of Dalotuzumab in Combination With Cetuximab + Irinotecan Versus ORR of Cetuximab + Irinotecan Alone in Participants With Wild Type of Colorectal Cancer|ORR, using RECIST 1.0, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.|Every 6 weeks (Up to 32 months)|The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.|||Percentage of Participants|||Number
1235963|NCT00614393|Primary|Percentage of Participants Who Experience an AE of Infusion Site Reaction|The percentage of participants who experienced an AE of infusion site reaction is presented.|Up to 30 days after last dose of study drug (Up to 33 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.|||Percentage of Participants|||Number
1235964|NCT00614393|Primary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. The percentage of participants who discontinued study drug due to an AE is presented.|Up to last dose of study drug (Up to 32 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.|||Percentage of Participants|||Number
1235965|NCT00614393|Primary|Percentage of Participants Who Have a Drug-related Clinical or Laboratory CTCAE Grade 3 to 5 Toxicity|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Drug-related AEs were those AEs that were possibly, probably, or definitely related to study drug or protocol-specified procedures. Participants were monitored for AEs related to dalotuzumab or placebo until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the NCI CTCAE, version 3.0.|Up to 30 days after last dose of study drug (Up to 33 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.|||Percentage of Participants|||Number
1235966|NCT00614393|Primary|Percentage of Participants Who Have a Clinical or Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 to 5 Toxicity|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Participants were monitored for AEs until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the National Cancer Institute (NCI) CTCAE, version 3.0.|Up to 30 days after last dose of study drug (Up to 33 months)|The All Participants as Treated (APaT) population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.|||Percentage of Participants|||Number
1235967|NCT00614393|Primary|Progression-free Survival (PFS)|The PFS of participants with metastatic CRC expressing the wtKRAS genotype was defined as the time from the first day of study treatment to the first documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST 1.0) as documented by an independent core laboratory, or death due to any cause, whichever occurred first. Disease progression was defined as either a 20% or greater relative increase in the sum of diameters of target lesions OR an absolute increase of at least 5mm in the sum of lesions or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Up to last dose of study drug (Up to 32 months)|The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.|||Months||Full Range|Median
1235968|NCT00614393|Primary|Overall Survival (OS)|The OS of participants with metastatic colorectal cancer (CRC) expressing the KRAS wild-type (wtKRAS) tumor genotype (indicating no detection of KRAS mutation) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and is reported in months.|Up to 12 weeks after last dose of study drug (Up to 35 months)|The Intent-to-Treat (ITT) population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.|||Months||Full Range|Median
1235969|NCT00614380|Secondary|Trough DBP Control Pre- and Post- Uptitration|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration|At any point during open-label treatment|Patients from the full analysis set who up-titrated to the higher dose of telmisartan 80 mg and amlodipine 10 mg. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
1236163|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 110 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1235970|NCT00614380|Secondary|Additional Reduction in SBP by Use of Additional Antihypertensive Therapy|Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Deviation|Mean
1235971|NCT00614380|Secondary|Additional Reduction in DBP by Use of Additional Antihypertensive Therapy|Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Deviation|Mean
1235972|NCT00614380|Secondary|Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
1235973|NCT00614380|Secondary|Time to First Additional Antihypertensive|Time from first intake of medication to first intake of an antihypertensive other than the study drug|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Days||Standard Deviation|Mean
1235974|NCT00614380|Secondary|Trough Blood Pressure (BP) Normality Classes|The number of patients who reach predefined BP categories|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
1235975|NCT00614380|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
1235976|NCT00614380|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
1235977|NCT00614380|Secondary|Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7|The difference between the last available troughs represents the additional reduction in SBP in this study|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Last value on treatment in 1235.5) and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
1235978|NCT00614380|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.|End of study (34 weeks or last value on treatment)|Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement|||mmHg||Standard Error|Least Squares Mean
1235979|NCT00614380|Secondary|Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7|The difference between the last available troughs represents the additional reduction in DBP in this study|End of study (34 weeks or last value on treatment)|Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement|||mmHg||Standard Error|Least Squares Mean
1235980|NCT00614380|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 1235.5) and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
1235981|NCT00614380|Secondary|Trough Seated Systolic Blood Pressure (SBP) Control|The number of patients who reach the target SBP of <140mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
1235982|NCT00614380|Primary|Trough Seated Diastolic Blood Pressure (DBP) Control|The number of patients who reach the target DBP of <90mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
1235983|NCT00614315|Secondary|Number of Device/Procedure-related Adverse Events(Safety of Delivery)|Device/Procedure-related adverse events from the index procedure through 30 days post procedure|Index Procedure to 30 days||||Number of Device/Procedure events|||Number
1235984|NCT00614315|Primary|Technical Success for Delivery|defined as deployment of the implant to the intended location, assessed at the time of the index procedure.|Measured at the time of implantation (Day 0)||||Percentage of successful implantations|||Number
1235985|NCT00614198|Secondary|Changes to Appearance of Multiple Compounds in Urine Samples||Baseline - 8 months -12 months - 24 months|||||||
1236002|NCT00614055|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).|Week 0 to Week 16 + 5 days follow up|The FAS included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
1236825|NCT00608491|Secondary|Change in Blood Hemoglobin Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||g/dL||Standard Deviation|Mean
1235986|NCT00614198|Primary|Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement.|ADOS (Autism Diagnostic Observation Schedule): module 1 cutoff scores (communication+social): autism=12, autism spectrum (AS)=7; module 2 cutoffs: autism=12, AS=8; module 3 cutoffs: autism=10; AS=7. GARS (Gilliam Autism Rating Scale): <80 low probability of autism, 81-90 below average, 91-110 average, >110 above average probability of autism. VABS (Vineland Adaptive Behaviour Scale): <69 (low ability), 70-84 (moderate/low), 85-115 (adequate), 116-130 (moderate/high), >130 (high). ADHD-IV: 0=no problems indicated. >11 attention & >11 hyperactivity = ADHD diagnosis.|Baseline - 8 months - 12 months - 24 months|Per protocol analysis. Analysis was conducted on n=26 (Gluten- and casein-free dietary intervention) and n=29 (No gluten- and casein-free dietary intervention) at 12 months. Analysis was conducted on n=18 and n=17 at 24 months (both on gluten- and casein-free dietary intervention).|||Units on a scale||Standard Error|Mean
1235987|NCT00614120|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-16|Safety Analysis Set is all randomised subjects who have been exposed to at least one dose of study products.|||episodes|||Number
1235988|NCT00614120|Secondary|Change in Fasting Lipid Profile, APO-B|Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||g/L||Standard Deviation|Median
1235989|NCT00614120|Secondary|Change in Fasting Lipid Profile|"Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:~Total Cholesterol (TC)~Low-density Lipoprotein-cholesterol (LDL-C)~Very Low-density Lipoprotein-cholesterol (VLDL-C)~High-density Lipoprotein-cholesterol (HDL-C)~Triglyceride (TG)~Free Fatty Acid (FFA)"|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1235990|NCT00614120|Secondary|Change in Beta-cell Function|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point (%point)||Standard Deviation|Mean
1235991|NCT00614120|Secondary|7-point Self-measured Plasma Glucose Profiles|Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).|week 0, 8, 12 and 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dl||Standard Deviation|Mean
1235992|NCT00614120|Secondary|Change in Self-measured Fasting Plasma Glucose|Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Deviation|Mean
1235993|NCT00614120|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to 16 weeks (end of treatment)|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Deviation|Mean
1235994|NCT00614120|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point of total HbA1c||Standard Deviation|Mean
1235995|NCT00614055|Secondary|Physical Examination|Physical examination is performed at baseline (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week 0, Week 8, Week 16|||||||
1235996|NCT00614055|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||beats/minute||Standard Deviation|Mean
1235997|NCT00614055|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
1235998|NCT00614055|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
1235999|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||umol/L||Standard Deviation|Mean
1236000|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||IU/L||Standard Deviation|Mean
1236826|NCT00608491|Secondary|Change in Blood Bicarbonate Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
1236004|NCT00614055|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1236005|NCT00614055|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 16|The FAS included all randomised subjects and missing data was imputed using LOCF.|||mmol/L||Standard Error|Mean
1236006|NCT00614055|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 16 weeks of treatment|Week 0, Week 16|The FAS included all randomised subjects and missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
1236007|NCT00614055|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1236008|NCT00613951|Secondary|Physical Examination|Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -4, Week 8, Week 16|||||||
1236009|NCT00613951|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.|||beats/minute||Standard Deviation|Mean
1236010|NCT00613951|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.|||mmHg||Standard Deviation|Mean
1236011|NCT00613951|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.|||mmHg||Standard Deviation|Mean
1236012|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 56 (SIAC 30), 57 (SIAC 45) and 56 (BIAsp 30) subjects contributed to the analysis at week 16.|||umol/L||Standard Deviation|Mean
1236013|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 3 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.|||IU/L||Standard Deviation|Mean
1236014|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.|||IU/L||Standard Deviation|Mean
1236015|NCT00613951|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1236016|NCT00613951|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
1236017|NCT00613951|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
1236018|NCT00613951|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 2 subjects, mean SMPG values were missing.|||mmol/L||Standard Error|Least Squares Mean
1236020|NCT00613938|Secondary|Total Pain Relief (TOTPAR)at 48 Hours|Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief.|48 hours|Intent-to-treat|||scores on a scale||Standard Deviation|Mean
1236021|NCT00613938|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3|Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3|Baseline and 3 days|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||percentage of participants|||Number
1236022|NCT00613938|Secondary|SPID at 24 Hours Relative to First Dose|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|24 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||Scores on a scale||Standard Deviation|Mean
1236023|NCT00613938|Secondary|The SPID at 12 Hours Relative to First Dose.|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|12 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||Scores on a scale||Standard Deviation|Mean
1236024|NCT00613938|Secondary|Time to First Rescue Pain Medication Use.|The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication.|3 days|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||||||
1236025|NCT00613938|Primary|Sum of Pain Intensity Difference Over 48 Hours (SPID48)|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|48 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||Scores on a scale||Standard Deviation|Mean
1236026|NCT00613925|Secondary|Sample Adequacy|adequacy of sample obtained for examination by a pathologist|at time of biopsy||||percentage of participants|||Number
1236027|NCT00613925|Primary|Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS).|"The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain in My Life (furthest point to the right)."|2 minutes after biopsy procedure|To demonstrate a 20 mm difference on the 100 mm visual analog scale, sample size of 35 women in each group (80% power, 0.05 alpha, SD 30mm)|||mm||Standard Deviation|Mean
1236028|NCT00613821|Primary|The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.|Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable).|Immediately (time zero) at uterine aspiration||||mm||Standard Deviation|Mean
1236029|NCT00613730|Secondary|Percentage of Participants With Overall Response|Overall Response defined as the percentage of participants with complete or partial response (CR or PR), as defined by modified RECIST. CR: Disappearance of all target and non-target lesions. PR: Either at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameters (SLD) and no progression of existing non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|Overall study|Study was terminated after enrolling 3 participants. This outcome was not evaluated.||||||
1236030|NCT00613730|Secondary|Progression-free Survival|Progression-Free Survival was defined as the time from Study Day 1 to the date of disease progression or the date of death due to any cause (whichever comes earlier). Disease progression is determined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria or per physician’s assessment based on symptom progression.|Up to 25 months|Study was terminated after enrolling 3 participants. This outcome was not evaluated.||||||
1236031|NCT00613730|Primary|Overall Survival at 1 Year|"The survival time is calculated from Study Day~1 (ie, the first day that a participant receives study treatment with the gemcitabine regimen in combination with panitumumab) to the date of death due to any cause."|12 months|Study was terminated after enrolling 3 participants. This outcome was not evaluated.||||||
1236032|NCT00613626|Secondary|Assess VEGF Polymorphisms and Correlate Subject Response||24 months|This data was not collected for the safety lead-in participants.|||probability|||Number
1236034|NCT00613626|Secondary|Measure Disease Control Rate (CR + PR+ SD) in Each Arm|Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as: neither a partial response or progressive disease ( >=20% increase in the sum of the longest diameter of the target lesions).|24 months|12 participants were not analyzed due to missing data.|||percentage of participants||95% Confidence Interval|Number
1236035|NCT00613626|Secondary|Measure the Response Rate (CR + PR) in Each Arm|Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions.|24 months|12 participants are excluded due to missing data.|||percentage of participants||95% Confidence Interval|Number
1236036|NCT00613626|Secondary|Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities|Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.|6 weeks (2 Cycles)|The participants from the safety run-in cohort were combined with the participants from ARM B for analysis of safety.|||percentage of participants|||Number
1236037|NCT00613626|Primary|Time to Disease Progression - Median Time to Progression and Log-Rank Test|Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.|24 months|Two participants from Arm A and Two Participants from Arm B were inevaluable for the time to disease progression analysis. (Reasons inevaluable include: toxicity and withdrawal of consent)|||Months||95% Confidence Interval|Median
1236038|NCT00613574|Secondary|Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS|Physician Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||participants|||Number
1236039|NCT00613574|Secondary|Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS|Physician Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||participants|||Number
1236040|NCT00613574|Secondary|Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS|Patient Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||participants|||Number
1236041|NCT00613574|Secondary|Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)|Patient Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||participants|||Number
1236042|NCT00613574|Secondary|Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks|Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites|Visit 1 to Visit 3 (baseline and 8 weeks)|Full Analysis Set (Intent-to-Treat population) and only patients from selected sites|||liters||Standard Deviation|Mean
1236043|NCT00613574|Secondary|Change From Baseline for Forced Vital Capacity After 8 Weeks|Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0)|baseline and final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||liters||Standard Deviation|Mean
1236044|NCT00613574|Primary|Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks|Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0)|baseline and final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||liters||Standard Deviation|Mean
1236045|NCT00613509|Secondary|Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term|"Common Terminology Criteria for Adverse Events (CTCAE) definitions:~Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event."|Day 0 to 12 months post last vaccination|Safety assessments were conducted in the As-treated safety population.|||Participants|||Number
1236046|NCT00613509|Secondary|Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response as mean duration of response were assessed in the intent-to-treat (ITT) evaluable population.|||Weeks||Full Range|Mean
1236047|NCT00613509|Primary|Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population|Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol|Day 0 - up to 35 weeks post 1st vaccination or treatment|The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.|||Weeks||Inter-Quartile Range|Median
1236048|NCT00613509|Other Pre-specified|Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)|The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay.|Day 0 to 32 weeks post 1st vaccination or treatment|Immunologic responses were assessed in the per-protocol evaluable population.|||Percent Cell Count||Standard Deviation|Mean
1236049|NCT00613509|Primary|Summary of Disease Progression in Study Participants, Intent-to-treat Population|Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).|Day 0 up to 35 weeks post 1st vaccination or treatment|The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.|||Participants|||Number
1236050|NCT00613509|Secondary|Best Overall Objective Response in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response were assessed in the intent-to-treat (ITT) evaluable population.|||Percentage of participants|||Number
1236051|NCT00613509|Secondary|Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response as number of participants responding was assessed in the intent-to-treat (ITT) evaluable population.|||Particpants|||Number
1236052|NCT00613509|Other Pre-specified|Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen|The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.|Day 0 to 32 weeks post 1st vaccination|Immunologic responses were assessed in the Per-protocol evaluable population.|||Participants|||Number
1236053|NCT00613509|Other Pre-specified|Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen|The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.|Day 0 to 32 weeks post 1st vaccination|Immunologic responses were assessed in the Per-protocol evaluable population.|||Participants|||Number
1236054|NCT00613405|Secondary|Current Mood as Assessed by the Mood Form||~2 hours|||||||
1236055|NCT00613405|Secondary|Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)||~2 hours|||||||
1236056|NCT00613405|Secondary|Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR||~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).|||||||
1236057|NCT00613405|Primary|Subjective Craving of Marijuana|Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving|approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).||||Scores on a Scale||Standard Deviation|Mean
1236058|NCT00613379|Primary|Maximum Change in Viral Load Following Initiation of Treatment.|The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).|59 days|All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.|||Log10copies HIV-1 RNA/mL||Standard Error|Mean
1236059|NCT00613366|Secondary|Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).|"Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right)."|At time of IUD insertion|ITT|||mm||Standard Deviation|Mean
1236060|NCT00613366|Primary|The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).|"Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right)."|Time of IUD insertion|Intent to Treat (ITT)|||mm||Standard Deviation|Mean
1236061|NCT00613327|Secondary|Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12|Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.|||Percent change||Standard Deviation|Mean
1236062|NCT00613327|Secondary|Visual Analogue Scale (VAS) Score for Dry Mouth|Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they have experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth).|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.|||Units on a scale||Standard Deviation|Mean
1236063|NCT00613327|Secondary|Mean Severity of Urinary Urgency at Urination|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency, 2=light urinary urgency, 3=moderate urinary urgency, 4=severe urinary urgency and 5=urge urinary incontinence). Mean severity of urinary urgency at urination was calculated as sum of all degrees of urinary urgency measured divided by the voiding frequency.|Baseline, Week 6, 12 or ED|Data was reported in individual participant listings as planned, but not statistically summarized for analysis.||||||
1236081|NCT00613314|Primary|Response Rate at the End of 30 Day Period|"Response rate of Blood Pressure assessed in the following categories:~Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline~Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg"|End of 30 day Period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||Percentage of patients|||Number
1236064|NCT00613327|Secondary|Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of UI for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.|||Percent change||Standard Deviation|Mean
1236065|NCT00613327|Secondary|Frequency of Urinary Urgency and Urinary Incontinence|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of urinary incontinence (UI) for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.|||Episodes per day||Standard Deviation|Mean
1236066|NCT00613327|Secondary|Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12|Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.|||Percent change||Standard Deviation|Mean
1236067|NCT00613327|Secondary|Mean Voiding Frequency|Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.|||Urinations per day||Standard Deviation|Mean
1236068|NCT00613327|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12|The OAB-q was used to evaluate influence of overactive bladder symptom on health-related quality of life (HRQL). It consisted of 2 parts: Symptom bother (6 items) evaluating how much symptoms related to overactive bladder were bothering in the last 4 weeks and HRQL (13 items) evaluating how general symptoms related to the bladder influenced life in the last 4 weeks. Each item was rated on 6-point Likert scale: 1 (not at all) to 6 (a very great deal). Total score range: 6 to 36 for symptom bother and 13 to 78 for HRQL. Transformed score calculated as ([Actual total raw score – lowest possible value of raw score]/range)*100 for symptom bother where higher score indicates greater symptom bother and as ([Highest possible raw score-Actual total raw score]/Raw score range)*100 for HRQL where higher scores indicate better HRQL. Transformed score range: 0-100 for both, symptom bother and HRQL.|Baseline, Week 6, 12 or early discontinuation (ED)|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.|||Units on a scale||Standard Deviation|Mean
1236069|NCT00613327|Secondary|Number of Participants With Response to Patient’s Perception of Bladder Condition (PPBC) Questionnaire|"Participant’s perception about bladder condition was evaluated by using self administered PPBC questionnaire. Participants answered “Which of the following statements describes your bladder condition best at the moment? on a 6-point scale: 1= not problematic at all, 2=mild problem, 3=more or less a mild problem, 4=moderate problem, 5=severe problem and 6=very severe problem."|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.|||Participants|||Number
1236070|NCT00613327|Secondary|Number of Participants With Response to Patient’s Perception of Treatment Benefit (PPTB) Questionnaire|The PPTB was used to assess participant’s perception about treatment benefit and satisfaction of the study drug. Regarding benefit, participants indicated whether they had any benefit obtained from the treatment. If yes, then the participants indicated whether it was weak benefit or strong benefit. Regarding satisfaction, participants indicated whether they were satisfied with the treatment. If yes, then they indicated if the treatment was slightly satisfactory or very satisfactory. If no, then they indicated if the treatment was slightly unsatisfactory or very unsatisfactory.|Week 2, 4, 6 and 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.|||Participants|||Number
1236071|NCT00613327|Secondary|Patient’s Perception of Symptom Improvement (PPSI) Score for Overactive Bladder|Participant’s perception about decrease in the most bothering symptom of overactive bladder (defined at Baseline) was evaluated by using visual analogue scale (VAS) at Week 12. The total score range was 0 to 100 where 0=symptom disappeared and 100=symptom unchanged or worsened compared to Baseline.|Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1236072|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urge urinary incontinence (involuntary voiding or urinary leakage due to sudden micturition desire, not by sneezing, coughing or laughing) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1236073|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by nighttime frequent urination (waking up from sleep in order to void urine at nighttime [period from time of going to bed to time planned to wake up in the morning]) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1236074|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by daytime frequent urination (frequent urination was required more than the frequency desired during daytime) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1236075|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urinary urgency (strong micturition desire indicated) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1236076|NCT00613327|Primary|Percentage of Participants Who Achieved Treatment Goal|Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported.|Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Missing data at Week 12 were imputed using last observation carried forward (LOCF).|||Percentage of participants||95% Confidence Interval|Number
1236077|NCT00613314|Secondary|Percentage of Patients With Presence of Metabolic Risk Factor|"Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely:~a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities,~based on patients’ Medical History"|At the end of 60 day period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||Percentage of patients|||Number
1236078|NCT00613314|Primary|Change in Diastolic Blood Pressure (DBP) From Baseline|Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)|Baseline and 60 days|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||mmHg||Standard Deviation|Mean
1236079|NCT00613314|Primary|Change in Systolic Blood Pressure (SBP) From Baseline|Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)|Baseline and 60 days|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||mmHg||Standard Deviation|Mean
1236080|NCT00613314|Primary|Response Rate at the End of 60 Day Period|"Response rate on Blood Pressure:~Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline.~Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline.~Sitting BP normalization < 130 mmHg and DBP < 85 mmHg"|At the end of 60 day period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||Percentage of patients|||Number
1236082|NCT00613301|Secondary|Change From Baseline in Modified Hoehn & Yahr Rating Scale|A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).|Baseline and at 36 months (or at the time of discontinuation)|The number of patients (295) means a population who have the assessment of Modified Hoehn & Yahr rating scale at baseline and at least one post-visit after administration of pramipexole.|||Unit on a scale||Standard Deviation|Mean
1236083|NCT00613301|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.|Baseline and at 36 months (or at the time of discontinuation)|The number of patients (291) means a population who have the assessment of UPDRS Part III total score at baseline and at least one post-visit after administration of pramipexole.|||Unit on a scale||Standard Deviation|Mean
1236084|NCT00613301|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|after 36 months treatment|There were 346 patients in the safety analysis set. Patients excluded from this population: 5 because of administration to patients who didn’t suffer from PD and 2 with no efficacy data available. As a result, 339 patients were evaluated for efficacy.|||Participants|||Number
1236085|NCT00613301|Primary|Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.|during 36 months|364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 patients in the safety analysis set.|||Proportion (percentage of participants)|||Number
1236086|NCT00613106|Primary|Number of Participants With Treatment Emergent Adverse Events|"The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as Has anything bothered you since your last visit or is anything bothering you now? Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event."|28 weeks||||participants|||Number
1236087|NCT00613080|Secondary|Number of Patients Who Underwent Abdominoperineal Resection|All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.|Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.|Eligible patients that had surgery|||Participants|||Count of Participants
1236088|NCT00613080|Secondary|Disease-free Survival: 4-year Rate|Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.|From registration to four years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1236089|NCT00613080|Secondary|Overall Survival: 4-year Rate|Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to four years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1236090|NCT00613080|Secondary|Distant Failure: 4-year Rate|Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method.|From registration to four years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1236091|NCT00613080|Secondary|Local-regional Failure: 4-year Rate|Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.|From registration to four years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1236105|NCT00612924|Primary|Successful Aneurysm Treatment|"defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of:~Aneurysm growth ≥ 5 mm as evaluated by the core laboratory~Post-operative interventions to correct type I or III endoleaks~Conversion to open surgical repair~Failed patency of both limbs~Migration requiring secondary procedure or intervention~Significant fracture~Aneurysm rupture"|365 days|In the ONE-LOK™ population, 85 subjects had efficacy endpoints and 9 subjects are missing due to withdrawal prior to 365-day follow-up. For the Anaconda population, 95 subjects had efficacy endpoints and 6 are missing data due to withdrawal prior to the 365-day follow-up.|||percentage of patients||95% Confidence Interval|Number
1236092|NCT00613080|Secondary|Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0|Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;|From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.|For the four time periods reported, respectively: all registered patients; patients that had surgery; patients that had surgery and postoperative chemotherapy; all registered patients.|||percentage of participants||95% Confidence Interval|Number
1236093|NCT00613080|Secondary|Number of Patients With Pathologic Complete Response|Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.|At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.|Eligible patients who started study treatment|||Participants|||Count of Participants
1236094|NCT00613080|Secondary|Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning|Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.|Pretreatment|Eligible patients who started study treatment|||Participants|||Count of Participants
1236095|NCT00613080|Primary|The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively|The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.|From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)|Eligible subjects who started study treatment.|||percentage of patients||90% Confidence Interval|Number
1236096|NCT00613028|Secondary|Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.|Incidence of ≥Grade 3 treatment related, non-hematologic toxicity|41 months||||participants|||Number
1236097|NCT00613028|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|41 months||||weeks||95% Confidence Interval|Median
1236098|NCT00613028|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|41 months||||weeks||95% Confidence Interval|Median
1236099|NCT00613028|Secondary|Radiographic Response|Percentage of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.|41 months||||percentage of participants|||Number
1236100|NCT00613028|Primary|The Primary Outcome Measure is 6 Month Progression-free Survival.|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months||||percentage of participants||95% Confidence Interval|Number
1236101|NCT00613015|Secondary|Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure|Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.|Immediately following trier + cocaine cue exposure||||mcg/dl||Standard Deviation|Mean
1236102|NCT00613015|Primary|Cocaine Craving|Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.|Post Trier social stress task + Cocaine Cue 2:30 pm||||units on a scale||Standard Deviation|Mean
1236103|NCT00612924|Primary|Freedom From Major Adverse Events|"The reported values represent the patients that did not experience a Major Adverse Event.~Participants did NOT experience:~All-Cause Mortality~Myocardial Infarction (MI)~Cerebrovascular Accident (CVA)~Renal Failure~Respiratory Failure~Paralysis or Paraplegia, or~Bowel Ischemia"|30 days|One Anaconda patient is not included in the analysis because their 30 day data was not reported.|||percentage of patients||95% Confidence Interval|Number
1236104|NCT00612924|Secondary|Secondary Effectiveness, Technical Success|Introduction and deployment of the Stent Graft in the absence of mortality, conversion to surgical repair, failed patency of both limbs, and evidence of a Type I or III endoleak through the first 24 hour post-operative period. The table below indicates the subjects who met the criteria for technical success based on Core Lab imaging evaluations.|24 hours|151 subjects (81 Anaconda and 70 ONE-LOK) had imaging available for core lab review and determination of technical success.|||participants|||Number
1236106|NCT00612807|Secondary|Beck Anxiety Inventory||pre-treatment, post-treatment, 6 month follow-up|||||||
1236107|NCT00612807|Secondary|Personal Assessment of Intimacy in Relationships||pre-treatment, post-treatment, 6 month-followup|||||||
1236108|NCT00612807|Secondary|SCID Mood Disorders||pre-treatment, post-treatment, 6 month follow-up|||||||
1236109|NCT00612807|Secondary|Conflict Tactics Scale||pre-treatment, post-treatment, 6 month follow-up|||||||
1236111|NCT00612807|Primary|Dyadic Adjustment Scale (DAS)|The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.|pre-treatment, monthly, post-treatment, 6 month follow-up||||Score on DAS measure||Standard Deviation|Mean
1236112|NCT00612807|Primary|Hamilton Depression Rating Scale (HDRS)|The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.|pre-treatment, monthly, post-treatment, 6 month follow-up||||Score on HDRS||Standard Deviation|Mean
1236113|NCT00612768|Secondary|Frequency of Late and Persistent Reactions|Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application|Day 2 (48 hours after application) through Day 21||||percentage of subjects with reactions|||Number
1236114|NCT00612768|Secondary|Irritation, Adhesion, Itching/Burning|Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.|Visit 2: 48 hours after patch application||||percentage of participants|||Number
1236115|NCT00612768|Primary|Agreement Between TRUE Test Allergen and Reference Allergen|Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen|Up to 21 days|The data from all enrolled subjects was analyzed.|||percentage of agreement||95% Confidence Interval|Number
1236116|NCT00612768|Primary|Analysis of Bioequivalence: Concordance|Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit|Up to 21 days|The data from 50 subjects enrolled in the study was analyzed|||percentage of agreement||95% Confidence Interval|Number
1236117|NCT00612690|Secondary|The Academic Competence Evaluation Scale (ACES)|The ACES is a teacher rating scale that describes a set of behaviors and attitudes measuring teachers’ perceptions of student's academic competence and performance. The scale consists of 30 items rated on a 5-point scale (1 = Never, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Almost Always). The total score was reported as a mean per item with higher scores indicating better academic competence. Scores could range from 1 to 30.|Measured at pre- and post-school year for 3 years|Only children with available data were included in the analyses.|||units on a scale||Standard Deviation|Mean
1236118|NCT00612690|Primary|Social Skills Rating System (Parent Report)|This rating scale was completed by parents to assess how frequently their child engaged in a range of disruptive, prosocial, and academic behaviors (0 = Never to 2 = Very Often). Normative data are provided by age and sex and the measure was standardized on a heterogeneous population of which one third were urban and 28% were minorities. The scale score, Social Skills, was the primary outcome measure. Scores are rated on a scale of 0 (Never) to 2 (Very Often). The scale score, Social Skills, containing 38 items, was the primary outcome measure. Scores range from 0 to 76 with higher scores indicating improved social skills.|Measured at pre- and post-school year for 3 years|Child participants with available data were included.|||units on a scale||Standard Deviation|Mean
1236119|NCT00612677|Secondary|Number of Participants Who Experienced Toxicities|We planned to determine the safety of the regimen (Drug Toxicities) assessed by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.||||||
1236120|NCT00612677|Secondary|Time to Progression (TTP)|We planned to calculate the median Time to Progression of all participants.|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.||||||
1236121|NCT00612677|Primary|Number of Patients Who Responded to Treatment|We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.||||||
1236122|NCT00612573|Secondary|Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population|Total Lesion Count is the sum of inflammatory and noninflammatory lesions.|Baseline to Week 12|ITT Population|||Lesions||Standard Deviation|Mean
1236123|NCT00612573|Secondary|Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population|Noninflammatory Lesion Count includes open and closed comedones.|Baseline to Week 12|ITT Population|||Lesions||Standard Deviation|Mean
1236124|NCT00612573|Primary|Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population|Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.|Baseline to Week 12|ITT Population|||Lesions||Standard Deviation|Mean
1236125|NCT00612573|Primary|Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population|IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.|Week 12|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
1236126|NCT00612560|Secondary|Growth Hormone Serum Levels IGF-1|Mean serum level IGF-1(pg/ml)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis|||pg/ml||Standard Deviation|Mean
1236127|NCT00612560|Primary|Human Epidermal Growth Factor Receptor 2 (Her2) Expression|Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis.|||percentage of cells||Standard Deviation|Mean
1236128|NCT00612560|Primary|Progesterone Receptor (PR) Expression|Mean percentage of cells expressing PR|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis|||percentage of cells||Standard Deviation|Mean
1236130|NCT00612534|Primary|SPID-12|SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.|12 hours after first dose|One patient in Sufentanil NanoTab 10 mcg group received the incorrect treatment so was not included in efficacy analysis|||units on a scale||Standard Error|Least Squares Mean
1236131|NCT00612508|Secondary|Adverse Events|Self-reported treatment-related and serious adverse events|over 168 days|All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event|||participants|||Number
1236132|NCT00612508|Primary|Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.|Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days|baseline, 84 days, 168 days|"A total of 14 subjects (7 R, 7 P) were randomized and had an initial biopsy; 11 (6 R, 5 P) returned for a biopsy at 3rd cycle (84 days), and 6 (3 R, 4 P) 6th cycle (168 days).~The analysis used a paired T test comparing the baseline mean to the mean as the end of the 3rd cylce (e.g. 84 days) and the 6th cycle (168 days)"|||mm||Standard Deviation|Mean
1236133|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Area Under Concentration Time-curve From Time Zero to 6 Hours (AUC [0-6)]|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter AUC (0-6) at Day 15 and Day 22.|Day 15 and Day 22|Pharmacokinetic population. Only those participants available at the specified time points were used for analysis.|||nanograms per hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1236134|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Time of Occurrence of Cmax (Tmax)|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter tmax at Day 15 and Day 22.|Day 15 and Day 22|Pharmacokinetic population. Only those participants available at the specified time points were used for analysis.|||hour||Full Range|Median
1236135|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Maximum Observed Concentration (Cmax)|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter Cmax at Day 15 and Day 22.|Day 15 and Day 22|The pharmacokinetic population included all participants in the Safety Population who received at least one dose of active treatment and a PK sample was obtained and analyzed. Only those participants available at the specified time points were used for analysis.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1236136|NCT00612456|Secondary|Change From Baseline in Neovascular Size, Total Lesion Size, Fluorescein Angiography (FA) Leakage Area of Measurement, FA Blood Area of Measurement as Measured by FA at Day 29|FA uses FP to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling or circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. The parameters assessed were CNV size, Classic CNV size, FA blood area of measurement, FA leakage area of measurement and total lesion size. A protocol fluorescein angiogram was to be obtained at Day 29. Images were evaluated by investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for change from baseline in change in eye characteristics in the study eye at Day 29. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|PD Parameter Population. Only those participants available at the specified time point were analyzed.|||millimeters||Standard Deviation|Mean
1236137|NCT00612456|Secondary|Number of Participants With Change in Characteristics (Fibrosis, Atrophy, Blood) as Measured by Fundus Photography (FP)|Fundus photography involves capturing of images of the center of the very back inner wall of the eye — the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme subretinal hemorrhage (absence or presence at the location), heme intraretinal hemorrhage (absence or presence at the location), subretinal fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment ((absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29.|Day 29|PD Parameter Population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
1236138|NCT00612456|Secondary|Number of Participants With Change in Retinal Morphology (Cystoid Spaces, Subretinal Fluid and Retinal Pigment Epithelial Detachment) as Determined by OCT|OCT was used for the determination of retinal morphology changes in the study eye which included assessments of cystoids spaces (cyst like spaces in the inner layers of the retina), subretinal fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and pigment epithelial detachment (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Data has been presented for number of participants with retinal morphology changes in the study eye at Day 29.|Day 29|PD Parameter Population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
1236139|NCT00612456|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) [Number of Letter Read on Standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) Charts at Day 29|BCVA was measured in the study eye using the ETDRS grading charts consists of at least 24 to 78 letters placed at a test distance of 4 meters. There were 7 cut off points in visual acuity on ETDRS grading chart: 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. Grade 15 to 29 indicates no impairment in vision and grade -15 to -29 indicates worst impairment in vision. Analyses were done for two sub-efficacy-populations. One sub-efficacy population included all participants in the efficacy population with a YES for retinal angiomatous proliferation (RAP)/retinal choroidal anastomosis (RCA) NONE field from Digital angiography reading center (DARC) FA form in study eye. The other included all participants in the efficacy population with a YES for eligible field from DARC FA form in study eye. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline calculated as subtracting the Baseline value from the value at Day 29.|Baseline (Day -3 to -1) and Day 29|Efficacy population comprised of all participants in the Safety Population who completed at least 7 days of pazopanib eye drop treatment and provided VA measurements and had CNV present as detected by FA. Only those participants available at the specified time points were included for analysis.|||Scores on scale||Standard Deviation|Mean
1236140|NCT00612456|Secondary|Number of Participants With Ocular Adverse Events, Non-ocular Adverse Events, Serious Ocular Adverse Events and Serious Non-ocular Adverse Events|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Data has been presented for number of participants with ocular and non-ocular adverse events and serious adverse event|Up to follow-up (Day 43)|Safety population|||Participants|||Count of Participants
1236141|NCT00612456|Secondary|Number of Participants With Abnormal Urinalysis Data by Dipstick Analysis|Urinalysis included analysis for urine occult blood, urine glucose, urine ketones and urine proteins via dipstick analysis. Data has been presented for number of participants with abnormal urinalysis results. Only categories with values have been presented.|Day 29 and follow-up (Day 43)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1236142|NCT00612456|Secondary|Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern|Clinical chemistry parameters assessed included blood urea nitrogen, potassium, calcium, albumin, creatinine, chloride, sodium, total protein, glucose, total carbon dioxide, aspartate amino transferase, alanine amino transferase, direct bilirubin, total bilirubin, alkaline phosphatase and hematology parameters assessed included platelet count, white blood cell count, red blood cell count, reticulocyte count, hemoglobin, mean corpuscle volume, mean corpuscle hemoglobin, mean corpuscle hemoglobin concentration, total neutrophils, lymphocytes, monocytes, eosinophils, basophils. Data has been presented for the number of participants with values high and low of potential clinical concern for clinical chemistry and hematology.|Up to follow-up Day 43|Safety population.|||Participants|||Count of Participants
1236143|NCT00612456|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|Single 12-lead ECGs were to be obtained at each Day 15 and follow-up Day 43 using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTc intervals. ECG findings were defined as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). Data has been presented for the number of participants with A-NCS and A-CS findings.|Day 15 and follow-up (Day 43)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1236144|NCT00612456|Secondary|Number of Participants With Vital Sign Data for Systolic Blood Pressure and Diastolic Blood Pressure and Heart Rate of Potential Clinical Concern|Vital sign assessments included systolic blood pressure, diastolic blood pressure and heart rate. The potential clinical concern range for systolic blood pressure was <85 and > 160 millimeters of mercury, diastolic blood pressure <45 and > 100 millimeters of mercury, heart rate <40 and >110 beats per minute. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important findings at any visit were reported.|Up to follow up (Day 46)|Safety population.|||Participants|||Count of Participants
1236145|NCT00612456|Secondary|Number of Participants With Complete Ophthalmic Examination Values of Potential Clinical Concern|A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 43.|Upto follow-up (Day 43)|Safety population comprised of all participants who received at least one dose of investigational product.|||Participants|||Count of Participants
1236164|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 60 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236165|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 30 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236166|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 10 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236146|NCT00612456|Primary|Mean Change From Baseline in Central Retinal/Lesion Thickness (CRLT) as Measured by the Carl Zeiss Meditec Stratus Optical Coherence Tomography (OCT) Scanner at Day 29|CRLT was measured by the Carl Zeiss Meditec Stratus OCT scanner based on the manual measurement of the distance between the inner and outer retina, inclusive of subretinal fluid and any choroidal neovascularization (CNV) as measured in the central 1 millimeter (mm) area of the 7 mm Posterior Pole Scan. OCT scans/images were collected by trained and certified photographer and analyzed by investigator. Two datasets were used for analysis namely Last observation carried forward (LOCF) which included missing assessment for a participant who completed at least 7 days of pazopanib eye drop replaced by the last non-missing assessment post 7 days of pazopanib eye drop treatment. OC dataset included a missing assessment at any scheduled time was considered unevaluable and was not imputed. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|Pharmacodynamics (PD) parameters population comprised of all participants in the Safety Population and had Choroidal Neovascularization (CNV) present as detected by Fluorescein Angiography (FA). LOCF and OC dataset were used for analysis. Only those participants with data available at the indicated time point were included for analysis.|||Microns||Standard Deviation|Mean
1236147|NCT00612430|Secondary|Median Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|median of 91.4 weeks||||weeks||95% Confidence Interval|Median
1236148|NCT00612430|Secondary|Median Progression-Free Survival|Time in weeks from the start of study treatment to the date of first progression, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Patients were followed for a median of 91.4 weeks||||weeks||95% Confidence Interval|Median
1236149|NCT00612430|Secondary|Safety of Study Treatment Regimen|Number of participants experiencing a non-hematologic toxicity ≥ grade 3 that was possibly, probably, or definitely related to study treatment.|2 years||||participants|||Number
1236150|NCT00612430|Secondary|Objective Response Rate|The percentage of participants with complete or partial response as determined by the following criteria: complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination; partial response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. A confirmation of response was not required.|2 years||||percentage of participants|||Number
1236151|NCT00612430|Primary|6 Month Progression-Free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans.|6 months||||percentage of participants||95% Confidence Interval|Number
1236152|NCT00612352|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|30 minutes|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
1236153|NCT00612352|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|Baseline|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
1236154|NCT00612352|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|30 minutes|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
1236155|NCT00612352|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|Baseline|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
1236156|NCT00612352|Secondary|Hopkins Verbal Learning Task - Delay Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Delay Recall: 30 minutes after Trials 1-3 were given) (0 no words recalled - 12 all words recalled)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236157|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 3|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 3|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236158|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 2|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 2|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236159|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 1|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 1|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236827|NCT00608491|Secondary|Change in Blood Urea Nitrogen/Urea||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1236167|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - Baseline|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236168|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 240 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|240 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236169|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 170 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236170|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 140 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236171|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 110 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236172|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 60 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236173|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 30 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236174|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 10 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236175|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - Baseline|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236176|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|240 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236177|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236178|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236179|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236180|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236181|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236182|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236183|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236184|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236185|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236186|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236187|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236188|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236828|NCT00608491|Secondary|Change in Blood Potassium Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
1236189|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236190|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236191|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236192|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 230 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236193|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 170 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236194|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 140 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236195|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 110 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236196|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 60 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236197|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 30 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236198|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol -10 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236199|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - Baseline|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236200|NCT00612352|Primary|Number of Drinks Felt Consumed at 230 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|230 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
1236201|NCT00612352|Primary|Number of Drinks Felt Consumed at 170 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|170 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
1236202|NCT00612352|Primary|Number of Drinks Felt Consumed at 140 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|140 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
1236203|NCT00612352|Primary|Number of Drinks Felt Consumed at 110 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|110 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
1236204|NCT00612352|Primary|Number of Drinks Felt Consumed at 30 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|30 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
1236205|NCT00612352|Primary|Number of Drinks Felt Consumed at 10 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|10 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
1236206|NCT00612352|Primary|Number of Drinks Felt Consumed at Baseline|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|Baseline|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
1236207|NCT00612339|Primary|Response Rate|The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|4 months|All subjects|||percentage of patients||95% Confidence Interval|Number
1236208|NCT00612313|Primary|Remission|Remission is defined as CDRS-R <=28.|Measured at Weeks 12, 18, 24, and 30||||probability of remitting (%)|||Number
1236209|NCT00612313|Secondary|Relapse|"Up through week 30, relapse was defined as:~1) CDRS-R score >=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R<40, but with a 2 week history of significant clinical deterioration.~From week 31-78, relapse was assessed using the K-Life. Relapse was defined as at least 2 weeks of a K-Life rating of 5 or 6; participants may also be identified as relapsing with a K-Life rating of 4 if the rating was for several weeks and not strictly related to stressful life events."|Weeks 52 and 78|Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.|||Probability of Relapse (%)|||Number
1236210|NCT00612313|Secondary|Remission|Remission is defined as CDRS-R <=28 (up through week 30) or at least 8 consecutive weeks of a K-Life rating of 1 or 2. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.|Weeks 52 and 78||||Probability of remission (%)|||Number
1236211|NCT00612313|Secondary|K-Life (Time Well)|"K-Life interview was conducted at Weeks 6, 12, 18, 24, and 30, with ratings for depressive illness for each week throughout the study.~Ratings definitions: 1=Normal, no residual symptoms; 2=Presence of 1 or more symptosm in no more than mild degree; 3=Considerably less psychopathology than full criteria, but still obvious evidence of disorder with no more than moderate impairment; 4=Does not meet full criteria, but has major symptoms or impairment from the disorder; 5=Meets full criteria, but no extreme impairment; 6=Meets full criteria, and either has prominent psychotic symptoms or extreme impairment.~Time well is defined as each week the depression rating was a 1 or 2. Percent time well was defined as each week the depression rating was a 1 or 2 divided by the total number of weeks in the study.~Statistic: anova"|30 weeks||||Weeks spent well||Standard Deviation|Mean
1236212|NCT00612313|Primary|Relapse|"Relapse was defined as:~1) CDRS-R score >=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R<40, but with a 2 week history of significant clinical deterioration."|Measured at Weeks 12, 18, 24, and 30|Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.|||probability of relapse (%)|||Number
1236213|NCT00612313|Primary|Time to Remission|Remission is defined as CDRS-R <=28. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.|30 weeks||||weeks||Standard Error|Mean
1236214|NCT00612235|Primary|Proportion of Women With PMDD in WWE and the Control Group|Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria.|Assessment of PMDD Designation after two consecutive menstrual cycles||||Participants|||Count of Participants
1236215|NCT00612235|Primary|To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.|Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria|Assessment of PMDD Designation after two consecutive menstrual cycles||||Participants|||Count of Participants
1236216|NCT00612222|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|15 months||||Participants|||Number
1236217|NCT00612222|Secondary|Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells|T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.||||||
1236218|NCT00612222|Primary|Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)|Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.|4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met||||Participants|||Number
1236219|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Unclassifiable"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants who could not be specifically differentiated in any of the other three subtypes were stratified as unclassifiable meaning that the participants could not be classified into any of the predefined PHN subtypes. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.|||Scores on a scale||Standard Deviation|Mean
1236220|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Deafferentation Type 2 (D Type 2)"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants with marked sensory loss and severe spontaneous burning pain without allodynia associated with reorganization of central nerve fibers were stratified in the “deafferentation type 2 subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.|||Scores on a scale||Standard Deviation|Mean
1236221|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) SubtypeDeafferentation Type 1 (D Type 1)"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants with marked sensory loss associated with severe burning pain upon slight mechanical stimuli (allodynia) were stratified in the deafferentation type 1 subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.|||Scores on a scale||Standard Deviation|Mean
1236222|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Irritable Nociceptors"|"Participants were stratified into four different PHN subtypes based on the NPPE. Participants with pain, abnormal sensitization of the specific receptor (irritable nociceptors), and with minimal sensory loss were stratified in theirritable nociceptors subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.|||Scores on a scale||Standard Deviation|Mean
1236223|NCT00612105|Secondary|Number of Participants With Indicated Responses at the End of the MP to the Questions: “How Sharp Was the Affected Side Compared to the Opposite Side?” and “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Hyperalgesia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Hyperalgesia is defined as increased sensitivity to pain, which may be caused by damage to peripheral nerves. It was assessed with a pinprick brush, based on the questions:How sharp was the affected side compared to the opposite side? and How painful was the affected side compared to the opposite side?"|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
1236224|NCT00612105|Secondary|Number of Participants With the Indicated Responses at the End of the MP to the Questions of “Is it Cool?” and “Is it Painful?” in an Assessment of Cold Threshold and Allodynia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Cold threshold and allodynia was assessed to determine if a metal bar felt cool and if it felt painful, based on the questions:Is it cool? and Is it painful?"|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
1236225|NCT00612105|Secondary|Number of Participants With the Indicated Responses at the End of the MP to the Question: “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Tactile Allodynia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Tactile allodynia was assessed with a foam brush, based on the question:How painful was the affected side compared to the opposite side? End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP."|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
1236226|NCT00612105|Secondary|Number of Subjects With the Indicated Responses at Baseline to the Questions: “How Sharp Was the Affected Side Compared to the Opposite Side?” and “How Painfule Was the Affected Side Compared to the Opposite Side?” in an Assessment of Hyperalgesia|"At Baseline the investigator conducted the NPPE to examine hyperalgesia and allodynia (tactile and cold). Hyperalgesia is defined as increased sensitivity to pain, which may be caused by damage to peripheral nerves. It was assessed with a pinprick brush, based on the questions: How sharp was the affected side compared to the opposite side? and How painfule was the affected side compared to the opposite side?"|Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Participants|||Number
1236227|NCT00612105|Secondary|Number of Participants With the Indicated Responses at Baseline to the Questions of “Is it Cool?” and “Is it Painful?” in an Assessment of Cold Threshold and Allodynia|"At Baseline the investigator conducted the NPPE to examine hyperalgesia and allodynia (tactile and cold). Cold threshold and allodynia was assessed to determine if a metal bar felt cool and if it felt painful, based on the questions:Is it cool? and Is it painful?"|Timeframe: Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Participants|||Number
1236228|NCT00612105|Secondary|Number of Participants With the Indicated Responses at Baseline to the Question: “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Tactile Allodynia|"At Baseline, the investigator conducted the Neuropathic Pain Physical Examination (NPPE) to examine hyperalgesia and allodynia (tactile and cold). Tactile allodynia was assessed with a foam brush, based on the question:How painful was the affected side compared to the opposite side?."|Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Participants|||Number
1236248|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.|||IU/L||Standard Deviation|Mean
1236229|NCT00612105|Secondary|Scores for Reported Health Transition at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP|"The least square (LS) mean score for reported health transition was calculated based on the scores (ranging from 1 to 5) given by the participant in answer to the following question: Compared to 1 year ago, how would you rate your health in general now?”. Lower numbers represent a better state of health."|End of maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.|||Scores on a scale||Standard Error|Least Squares Mean
1236230|NCT00612105|Secondary|Scores on the Medical Outcomes Short Form-36 (SF-36) at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP|Least square (LS) mean calculated based on participant's assessment of SF-36,a quality of life questionnaire consisting of 36 items grouped into 8 domains. These 8 domains further grouped into 2 overall summary measures,physical health and mental health. Higher scores on SF-36 represented better state of health. Physical/mental components summarized the data of all the physical/mental domains of SF-36 and higher scores represented better state of health.|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.|||Scores on a scale||Standard Error|Least Squares Mean
1236231|NCT00612105|Secondary|Scores on the Brief Pain Inventory-Short Form (BPI-SF) at the End of the MP for All Participants Who Completed Week-4 of the MP and Who Terminated Early During the MP|The BPI-SF assessed pain intensity, pain relief from medication, and pain interference with function over the previous 24 hours. Pain intensity was assessed by the mean of 4 intensity items rated on a 0-10 categorical scale: 0=no pain, 10=pain as bad as you can imagine. Pain interference was assessed by determining the mean of the 7 interference items on a 0-10 categorical scale ranging from 0=does not interfere to 10=completely interferes. The level of pain relief provided by treatment was assessed on an 11-point categorical scale ranging from 0% to 100%|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.|||Scores on a scale||Standard Deviation|Mean
1236232|NCT00612105|Secondary|Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) at the End of the Maintenance Phase|The TSQM assessed the participant's overall satisfaction with treatment, including subscales to assess effectiveness, side effects, convenience, and global satisfaction. Raw scores from the scale were transformed into a numeric scale ranging from 0 to 100, where higher scores indicated greater satisfaction with treatment. TSQM was reported at the end of the MP. Participants who completed Week 4 of the MP and who terminated early during the MP were assessed.|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.|||Scores on a scale||Standard Deviation|Mean
1236233|NCT00612105|Secondary|Number of Participants With the Indicated Overall Patient Global Impression of Change (PGIC)|For the PGIC assessment, participants were asked to assess their overall status since they initiated the study drug to the end of the Maintenance Phase using a 7-point categorical scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. All participants who completed Week 4 of the Maintenance Phase and participants who terminated early during the Maintenance Phase were assessed.|Baseline to the end of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
1236234|NCT00612105|Secondary|Number of Participants With the Indicated Change From Baseline to the End of the Maintenance Phase in Optimal Sleep Based on the Sleep Quantity Domain of the MOS Sleep Scale|"Optimal Sleep was based on the Sleep Quantity domain of the MOS Sleep Scale and included the options of Yes if sleep quantity was 7-8 hours, and No otherwise. Improved indicated a change in response of no at baseline to yes at the end of the MP, Same indicated no change in response, and Worse indicated a change in response from yes at baseline to no at the end of the MP."|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
1236235|NCT00612105|Secondary|Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Sleep Quantity|Change from Baseline in sleep quantity was calculated by subtracting the average value of sleep quantity, calculated in hours, at the end of the MP from the average Baseline value.|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Hours||Standard Deviation|Mean
1236236|NCT00612105|Secondary|Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Medical Outcomes Study (MOS) Sleep Scale Scores|Change from BL (average value of MOS Sleep Scale score including Overall Sleep Problem [OSP] Index at end of MP minus average BL value) to the end of the MP was summarized for the OSP Index, in addition to the following subscales of the MOS Sleep Scale: Sleep Disturbance; Sleep Adequacy; Snoring; Awakening with Shortness of Breath or with a Headache; Somnolence; and Optimal Sleep. Each item was transformed to a scale with a range of 0-100. For each subscale, except Optimal Sleep, higher scores indicate a greater level of what was being measured (i.e., more snoring, more sleep adequacy, etc.).|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Scores on a scale||Standard Deviation|Mean
1236237|NCT00612105|Secondary|Number of Participants Classified as Responders, With a 50% and 30% Pain Reduction From Baseline to the Last 7 Days of the Maintenance Phase|Responders were defined as participants achieving a mean >=50% or >=30% pain reduction based on the NRS score from Baseline to the last 7 days of the MP. Those participants who did not have at least 3 diary entries in the MP, those who withdrew during the Titration Phase (TP), and non-completers (NC: who did not complete the study) were classified as non-responders. The number of responders and responders including non-completers from Baseline to the last 7 days of the MP were reported.|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. All participants providing data for this analysis had to have 7 available baseline diary entries.|||Participants|||Number
1236238|NCT00612105|Secondary|Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)|Least square mean (LSM) of pain intensity was calculated from the NRS score entered by the participants in their diaries at each week during the MP. Participants rated their pain during the previous 24 hours at all clinic visits using an NRS: 0, no pain; 1-3, mild; 4-6, moderate; 7-10 (worst possible pain), severe pain. Change from Baseline was calculated by subtracting the value of the average of the LSM of the NRS score at each week during the MP (the last 7 available diary entries in the MP were used, provided at least 3 existed) from the average Baseline value of the LSM of the NRS score.|Baseline and Weeks 1, 2, 3, and 4 (MP)|ITT Population. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Scores on a scale||Standard Deviation|Mean
1236239|NCT00612105|Secondary|Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)|Participants recorded the number of acetaminophen tablets taken during the previous 24 hours in a participant diary. Rescue medication was summarized as the mean number of doses taken per day during each week of the Maintenance Phase (MP) and the mean number of doses taken during all MP weeks.|Weeks 1, 2, 3, and 4 Maintenance Phase|ITT Population. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Tablets/Day||Standard Deviation|Mean
1236240|NCT00612105|Secondary|Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment|Participants rated their pain during the previous 24 hours at all clinic visits using an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain (10=worst possible pain). Change in In-clinic Pain Assessment was calculated by subtracting the average score on the NRS at Week 2 and Week 4 (values for each week were observed cases) of the MP from the average score on the NRS at Baseline (the last non-missing measurement prior to taking study drug).|Baseline and Weeks 2 and 4 (Maintenance Phase - MP)|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy assessment. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Scores on a scale||Standard Deviation|Mean
1236241|NCT00612105|Primary|Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.|Change from Baseline (BL) was calculated as the value of the average diary pain score for the last 7 days of the MP minus the value of the average pain score at BL (post wash-out period, including the average of the last 7 available entries prior to/including the diary pain measurement on Titration Day 0). Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain.|Baseline and Week 4 (Maintenance Phase-MP)|Per Protocol (PP) Population: all randomized participants who completed the Titration Phase, had at least 1 dose of treatment in the MP, had at least 3 diary entries in the MP, and did not have any protocol violations or any major protocol deviations|||Scores on a scale||Standard Error|Least Squares Mean
1236242|NCT00612066|Primary|Number of Responders|"Definition of Treatment Response~The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression.~Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression)."|7 weeks|Sample size was too small to do a valid analysis.|||participants|||Number
1236243|NCT00612040|Secondary|Physical Examination|Physical examination was performed at screening (week -1), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -1, Week 8, Week 16|||||||
1236244|NCT00612040|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.|||beats/minute||Standard Deviation|Mean
1236245|NCT00612040|Secondary|Vital Signs: Systolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.|||mmHg||Standard Deviation|Mean
1236246|NCT00612040|Secondary|Vital Signs: Diastolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.|||mmHg||Standard Deviation|Mean
1236247|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.|||umol/L||Standard Deviation|Mean
1236286|NCT00611767|Secondary|Verbal Fluency|"Verbal Fluency Task: requires subjects to generate as many words as possible beginning with a single letter (e.g., H) during a one-minute interval. (total words in one-minute interval)"|15 minutes|All available data was utilized in the analysis using mixed models.|||number of words||Standard Deviation|Mean
1236249|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.|||IU/L||Standard Deviation|Mean
1236250|NCT00612040|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1236251|NCT00612040|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
1236252|NCT00612040|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
1236253|NCT00612040|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
1236254|NCT00612040|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||mmol/L||Standard Deviation|Mean
1236255|NCT00612040|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1236256|NCT00611897|Secondary|Mismatch Negativity (MMN) Duration|"Mismatch Negativity (MMN) Duration difference waves at midline electrodes (Fz, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
1236257|NCT00611897|Secondary|Mismatch Negativity (MMN) Frequency|"Mismatch Negativity (MMN) Frequency difference waves at midline electrodes (Fx, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
1236258|NCT00611897|Primary|Novel P300|"The Novel P300 measures were obtained from the Fz, Cz and Pz electrodes.~Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL."|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
1236259|NCT00611897|Secondary|Mismatch Negativity (MMN) Intensity|"Mismatch Negativity (MMN) Intensity difference waves at midline electrodes (Fz, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
1236260|NCT00611897|Primary|Target P300|"The Target P300 measures were obtained from the Fz, Cz and Pz electrodes.~Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL."|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
1236261|NCT00611884|Secondary|Physical Examination|Physical examination was performed at screening (Week -4), randomisation (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -4, Week 0, Week 8, Week 16|||||||
1236262|NCT00611884|Secondary|Vital Signs: Pulse|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||beats/minute||Standard Deviation|Mean
1236263|NCT00611884|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
1236264|NCT00611884|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
1236265|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||umol/L||Standard Deviation|Mean
1236266|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||IU/L||Standard Deviation|Mean
1236267|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||IU/L||Standard Deviation|Mean
1236268|NCT00611884|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1236269|NCT00611884|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
1236270|NCT00611884|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
1236271|NCT00611884|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
1236272|NCT00611884|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1236273|NCT00611858|Other Pre-specified|1-Year Disease-Free Survival Rate|Disease-Free Survival Rate is the percentage of participants remaining alive without disease progression.|CT scans for surveillance recommended yearly x 3 years from date of surgery with additional scanning at discretion of treating oncologist. Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
1236274|NCT00611858|Secondary|1-Year Overall Survival Rate|1-year overall survival is the percentage of participants remaining alive 1 year from study entry.|Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.||||percentage of participants||90% Confidence Interval|Number
1236275|NCT00611858|Secondary|Incidence of Grade 4 Treatment-Related Toxicity|All grade 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 4 AE of any type during the time of observation.|Disease is assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.|The analysis dataset is comprised of all enrolled patients.|||Participants|||Count of Participants
1236305|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 45 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236276|NCT00611858|Secondary|Distant Recurrence Rate|Distant recurrence rate is the percentage of participants experiencing recurrence outside the pelvis.|CT scans for surveillance recommended yearly x 3 years from date of surgery with additional scanning at discretion of treating oncologist. Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
1236277|NCT00611858|Secondary|Complete Resection Rate|Complete resection rate is the percentage of participants having all gross disease removed by the surgeon at the time of operation.|Disease is assessed at the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
1236278|NCT00611858|Secondary|Local Recurrence Rate|Local recurrence rate is the percentage of participants experiencing recurrence within the pelvis.|CT scans for surveillance recommended yearly x 3 years from date of surgery with additional scanning at discretion of treating oncologist. Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
1236279|NCT00611858|Primary|Pathological Complete Response Rate|Pathological complete response (pCR) rate is the percentage of participants who achieve pCR defined as no evidence of tumor cells in the surgical specimen including the lymph nodes (down-staging to pathological T0, N0 after planned neoadjuvant therapy).|Disease is assessed at the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
1236280|NCT00611806|Secondary|Relationship Between Response of Negative and Positive Symptoms and the Change in RBC Folate, Serum Folate, Serum B12, and Plasma Homocysteine Concentrations||Measured at Week 16|||||||
1236281|NCT00611806|Secondary|Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype|The change from baseline on the Positive and Negative Syndrome Scale (PANSS) (including FOLH1, MTHRF, MTR, and COMT genotype simultaneously into a linear mixed model).The PANNS has three sub-scales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS negative and positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7 representing the negative and positive symptoms of schizophrenia, respectively, and the general psychopathology sub-scale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135) and agreed to the DNA blood draw (n = 120).|||units on a scale||95% Confidence Interval|Mean
1236282|NCT00611806|Secondary|Scale for Assessment of Negative Symptoms (SANS)|The change from baseline on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total SANS score per week, whereas a positive score represents an increase in total SANS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the SANS assessment was performed.|||units on a scale||95% Confidence Interval|Mean
1236283|NCT00611806|Secondary|Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)|The change from baseline on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the PANSS assessment was performed.|||units on a scale||95% Confidence Interval|Mean
1236284|NCT00611806|Secondary|Cognitive Deficits, as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognitive Battery Composite Score||Measured at Week 16|||||||
1236285|NCT00611806|Primary|Positive and Negative Syndrome Scale (PANSS)|The change from baseline on the Positive and Negative Syndrome Scale (PANSS).The PANNS has three subscales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7, representing positive symptoms of schizophrenia. The PANSS negative symptom subscale is comprised of 7 items rated on a scale of 1-7 representing the negative symptoms of schizophrenia, and the general psychopathology subscale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the PANSS assessment was performed.|||units on a scale||95% Confidence Interval|Mean
1236287|NCT00611767|Secondary|Hopkins Verbal Learning Task (HVLT) - Delayed Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function with word recall at 30 minutes) (0 no words recalled - 12 all words recalled)|45 minutes|All available data was utilized in the analysis using mixed models.|||words recalled||Standard Deviation|Mean
1236288|NCT00611767|Secondary|Hopkins Verbal Learning Task (HVLT) - Total Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function based on word recall. (0 = no words recalled - 36 = all words recalled)|15 minutes|All available data was utilized in the analysis using mixed models.|||words recalled||Standard Deviation|Mean
1236289|NCT00611767|Secondary|Pegboard Task - 15 Minutes (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|15 minutes|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
1236290|NCT00611767|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|Baseline|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
1236291|NCT00611767|Secondary|Pegboard Task - 15 Minutes (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|15 minutes|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
1236292|NCT00611767|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|Baseline|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
1236293|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 110 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236294|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 80 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236295|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 15 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236296|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - Baseline|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236297|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 110 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236298|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 80 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236299|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 15 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236300|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - Baseline|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236301|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 230 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236302|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 170 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236303|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 110 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236304|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 80 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236306|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 15 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236307|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - Baseline|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236308|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 230 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236309|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 170 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236310|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 110 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236311|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 80 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236312|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 45 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236313|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 15 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236314|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - Baseline|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236315|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 230 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236316|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 170 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236317|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 110 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236318|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 80 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236319|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 45 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236320|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 15 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236321|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - Baseline|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236322|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 230 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236323|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 170 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236324|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 110 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236325|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 80 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236326|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 45 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|45 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236327|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 15 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|15 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236328|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - Baseline|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|Baseline|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236329|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 230 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|230 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236330|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 170 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|170 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236331|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 110 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|110 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236332|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 80 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|80 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236333|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 45 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|45 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236334|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 15 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236335|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - Baseline|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236336|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236337|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236338|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236339|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 80 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236340|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 45 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236341|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 15 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|15 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1236342|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236343|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 230 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236344|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236345|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant- 110 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236346|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 80 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236347|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 45 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236348|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 15 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236349|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236350|NCT00611767|Secondary|Number of Drinks Felt Consumed - 230 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|230 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
1236368|NCT00611624|Secondary|Information of Treatment Parameters in Order to Define Parameters Most Predictive of Skin Toxicity|These data were not collected and were not summarized in this study. Results are not available.|Upon completion of study|||||||
1236351|NCT00611767|Secondary|Number of Drinks Felt Consumed - 170 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|170 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
1236352|NCT00611767|Secondary|Number of Drinks Felt Consumed - 110 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|110 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
1236353|NCT00611767|Secondary|Number of Drinks Felt Consumed - 80 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|80 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
1236354|NCT00611767|Secondary|Number of Drinks Felt Consumed - 45 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|45 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
1236355|NCT00611767|Secondary|Number of Drinks Felt Consumed - 15 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|15 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
1236356|NCT00611767|Secondary|Number of Drinks Felt Consumed at Baseline|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|Baseline|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
1236357|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 230 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236358|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 170 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236359|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 110 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236360|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 80 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236361|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 45 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236362|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 15 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236363|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - Baseline|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
1236364|NCT00611715|Secondary|Number of Patients With Worst-grade Toxicities Per Grade|Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death|at 24 weeks|All patients who received treatment and experienced an adverse event.|||participants|||Number
1236365|NCT00611715|Secondary|Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions.|at 24 weeks|Analysis population is patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.|||participants|||Number
1236366|NCT00611715|Secondary|Median Time to Progression of Target Lesions|Time frame from study entry till discontinuation of treatment due to disease progression. Progression of target lesions is measured by RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.|Every 12 weeks from on-study to disease progression|Patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.|||Months||Full Range|Median
1236367|NCT00611715|Primary|Number of Patients With Pathological Complete Response.|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|at 24 weeks|Analysis population is patients who were available for response measurement. Some patients did not meet the criteria to be analyzed for response evaluation which accounts for the discrepancy in patients analyzed vs. total accrual population.|||participants|||Number
1236369|NCT00611624|Primary|Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.|Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.|one year|26 participants completed the 1 year assessment.|||Participants|||Count of Participants
1236370|NCT00611559|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Up to one month after the booster dose administration||||subjects|||Number
1236371|NCT00611559|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) post-vaccination period||||subjects|||Number
1236372|NCT00611559|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite|Within the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
1236373|NCT00611559|Secondary|Anti-poliovirus Antibodies Titer|Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||titer||95% Confidence Interval|Geometric Mean
1236374|NCT00611559|Secondary|Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose|Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50|Before the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236375|NCT00611559|Secondary|Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose|Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL|Before the booster dose administration (at baseline)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||EL.U/mL||95% Confidence Interval|Geometric Mean
1236376|NCT00611559|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose|Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236377|NCT00611559|Secondary|Anti-diphtheria and Anti-tetanus Antibodies Concentration|Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||IU/mL||95% Confidence Interval|Geometric Mean
1236378|NCT00611559|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL|Before the booster dose administration (at baseline)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236379|NCT00611559|Secondary|Anti-PRP Antibodies Concentration|Concentration of anti-PRP antibodies given as GMC in µg/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||µg/mL||95% Confidence Interval|Geometric Mean
1236380|NCT00611559|Secondary|Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose|"Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL~Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes"|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236381|NCT00611559|Secondary|Anti-HB Antibodies Concentration|Concentration of anti-HB antibodies given as GMC in mIU/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||mIU/mL||95% Confidence Interval|Geometric Mean
1236382|NCT00611559|Secondary|Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose|"Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL~Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes"|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236383|NCT00611559|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose|Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||EL.U/mL||95% Confidence Interval|Geometric Mean
1236384|NCT00611559|Primary|Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose|Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236385|NCT00611559|Primary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236386|NCT00611559|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose|Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236387|NCT00611559|Primary|Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose|Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)|One month after the booster dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1236388|NCT00611533|Secondary|Weight||Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.|||lb||Standard Deviation|Mean
1236389|NCT00611533|Secondary|Heart Rate||Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.|||beats/min||Standard Deviation|Mean
1236390|NCT00611533|Secondary|Blood Pressure||Baseline and after 6 weeks intervention|Participants who had least one post randomization visit.|||mm Hg||Standard Deviation|Mean
1236391|NCT00611533|Primary|BADDS Total Score|The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus.|Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.|||units on a scale||Standard Deviation|Mean
1236392|NCT00611533|Primary|Brown Attention Deficit Disorder Scale|Raw scores for 5 clusters (organizing/activating, attention/concentration, alertness/effort/processing, managing affect interference, and working memory/recall) on the BADDS were converted to T scores which range from 50-99, with higher scores meaning greater impairment.|Baseline and after 6 weeks intervention|Participants who completed both interventions.|||T score||Standard Deviation|Mean
1236393|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.|||ng*h/mL||Standard Deviation|Mean
1236394|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. However, only 13 were able to be analyzed for the renal clearance because in 5 patients the amount of topotecan measured in the urine was more than the topotecan dose that was given. Renal clearance was not calculated for those patients.|||L/h/m^2||Standard Deviation|Mean
1236395|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.|||L/h/m^2||Standard Deviation|Mean
1236396|NCT00611468|Primary|Dosage Limiting Toxicities||DLT were assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21)|DLT were assessed using NCI CTCAE version 3.0. After MTD was determined, 13 additional patients were enrolled to enhance estimation of PK parameters. The first 8 were enrolled at dose 2. Because 4 of these patients experienced a DLT, the remaining 5 patients were enrolled at dose level 1. Of these, 1 experienced a DLT.|||Participants|||Number
1236397|NCT00611468|Secondary|Objective Response (as Determined Using RECIST 1.0 Criteria)||Every 6 weeks until the end of study treatment|After the determination of MTD, an additional 13 patients were enrolled to enhance estimation of PK parameters. The first 8 patients were enrolled at dose level 2, 4 of whom experienced a DLT. Thus, the remaining 5 patients were enrolled at dose 1. One of these patients experienced a DLT.|||Participants|||Number
1236398|NCT00611468|Secondary|Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)|Each subgroup lists the gene on which a polymorphism occurred (e.g., CYP3A4), the name of the polymorphism (e.g., *1), whether it was heterozygous or a variant, the number of subjects with available data, and the number who had the polymorphism.|Baseline|Pharmacokinetic studies were done for all 29 consenting patients (one of whom later withdrew).|||Participants|||Number
1236399|NCT00611468|Primary|Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib|The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).|DLT information was available for 3 patients who received a topotecan dose of 0.75 mg/M^2, for 6 patients who received a topotecan dose of 1.0 mg/M^2, and for 6 patients who recived a topotecan dose of 1.25 mg/M^2. 1 additional patient received a dose 1.0 mg/M^2 but withdrew before completing cycle 1. This patient had no DLT and was replaced.|||mg/m^2|||Number
1236400|NCT00611455|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.|||Participants|||Number
1236716|NCT00608985|Primary|Change From Baseline to Day 15&16 in WASO|"WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.~For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16"|From baseline to Day 15&16|All treated patients|||minutes||95% Confidence Interval|Median
1236401|NCT00611455|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; Creatinine: N/A, 1.2; CO2/BCO: 0.85/0.75, 1.2/1.3; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.|||Participants|||Number
1236402|NCT00611455|Secondary|Number of Participants With a Positive JC Virus Test Result During the Follow-up Period|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicated the presence of JC Virus.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236403|NCT00611455|Secondary|Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab|Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.|From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Months||Full Range|Median
1236404|NCT00611455|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period|The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236405|NCT00611455|Secondary|Number of Participants With Any Serious Adverse Event During the Follow-up Period|A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])|Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.|||Participants|||Number
1236406|NCT00611455|Secondary|Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)|Only those parameters for a particular flag (<LLN or >ULN) are summarized if at least one value was outside the specified reference range. The Baseline (BL) value for a TC was defined as the latest value on or before the date of infusion A of the TC. However to be evaluable as a baseline value, assessments must have been conducted within a 14 day window prior to the date of infusion A. The post-baseline (PBL) was any visit after the date of infusion A during the specified TC. The pre-defined LLN for biomarkers are: B-lymphocyte stimulator (B-ls):<486.5 nanograms per Liter (ng/L); Interleukin-6 (IL-6):<0.31ng/L and Serum amyloid A: <1951 ng/mL. LLN was not defined for Rheumatoid factor (RF)-IgA, RF-IgG, RF-IgM or anti- cyclic citrullinated peptide (CCP) antibody and RF. The pre- defined ULN range for biomarkers (RF)-IgA: >6 units; RF-IgG:>6 units; RF-IgM:>6 units; Anti-CCP:>19.9999 units; B-ls:>1343.3 ng/L; IL-6: >5 ng/L; RF:>11.9999 kilounits (KU)/L; Serum amyloid A:>82432 ng/mL.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236407|NCT00611455|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Lymphocytes: 0.4, 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.75, 2; White blood cell count (WBC): 0.7, 1.6.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236417|NCT00611455|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||participants|||Number
1236829|NCT00608491|Secondary|Change in Blood Sodium Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
1236408|NCT00611455|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85/0.75, 1.2/1.3, ; Chloride: 0.9, 1.1; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Lactate dehydrogenase (LDH): NA, 2; Potassium: 0.9, 1.1; Sodium: 0.93, 1.07; Total protein: 0.8, 1.15; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236409|NCT00611455|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period|The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.|From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236410|NCT00611455|Secondary|Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236411|NCT00611455|Secondary|Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236412|NCT00611455|Secondary|Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236413|NCT00611455|Secondary|Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236414|NCT00611455|Secondary|Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1236415|NCT00611455|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.|First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144|AT Population|||Participants|||Number
1236416|NCT00611455|Secondary|Time to Retreatment, by Ofatumumab Treatment Course|Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.|From Baseline up to Week 144|AT Population. Only those participants who were retreated from Week 24 were analyzed.|||Weeks||Standard Deviation|Mean
1236418|NCT00611455|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||participants|||Number
1236419|NCT00611455|Secondary|Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
1236420|NCT00611455|Secondary|Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
1236421|NCT00611455|Secondary|Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
1236422|NCT00611455|Secondary|Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).|First 24 weeks of each treatment course (assessed up to Week 144)|As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period. Only those participants contributing values at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
1236423|NCT00611455|Secondary|Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24|The following biomarkers were assessed: Interleukin 6 (IL-6) and Serum Amyloid A. These biomarkers were used to further characterize disease activity.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||nanogram per liter (ng/l)||Full Range|Median
1236424|NCT00611455|Secondary|Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24|The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||Units/Liter||Full Range|Median
1236491|NCT00610883|Primary|Complete Remission|The number of patients who achieved a complete remission as a result of treatment|330 Days||||participants|||Number
1236425|NCT00611455|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24|"The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
1236426|NCT00611455|Secondary|Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Error|Least Squares Mean
1236427|NCT00611455|Secondary|Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Error|Least Squares Mean
1236428|NCT00611455|Secondary|Change From Baseline in ESR at Week 24|ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||millimeters per hour (mm/hr)||Full Range|Median
1236429|NCT00611455|Secondary|Change From Baseline in CRP at Week 24|Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from Baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||milligrams per liter (mg/L)||Full Range|Median
1236430|NCT00611455|Secondary|Change From Baseline in HAQ-DI Score at Week 24|The self-assessed HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Change from baseline was calculated as the value at Week 24 minus the baseline value.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
1236431|NCT00611455|Secondary|Change From Baseline in the Physician-assessed Global Disease Score at Week 24|"The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
1236432|NCT00611455|Secondary|Change From Baseline in Participant-assessed Global Disease Score at Week 24|"The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
1236433|NCT00611455|Secondary|Change From Baseline in the Participant-assessed Pain Score at Week 24|"A horizontal VAS of 100 mm was used to report the participant’s level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
1236492|NCT00610857|Secondary|Median Overall Survival (Point Estimate)|Median overall survival is the (point) estimate of the time corresponding to 50% estimated probability of survival.|Up to 44 months||||months||95% Confidence Interval|Median
1236434|NCT00611455|Secondary|Change From Baseline in Swollen Joint Count at Week 24|Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||number of swollen joints||Full Range|Median
1236435|NCT00611455|Secondary|Change From Baseline in Tender Joint Count at Week 24|Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||number of tender joints||Full Range|Median
1236436|NCT00611455|Secondary|Number of Participants With Clinical Remission at Week 24|Participants achieving clinical remission were defined as those with a low disease activity, i.e., DAS28 score (using CRP) <2.6 at Week 24.|Week 24|ITT Population|||participants|||Number
1236437|NCT00611455|Secondary|Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.|Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||participants|||Number
1236438|NCT00611455|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||participants|||Number
1236439|NCT00611455|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||participants|||Number
1236440|NCT00611455|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1236441|NCT00611455|Secondary|Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1236442|NCT00611455|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1236443|NCT00611455|Secondary|Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1236444|NCT00611455|Secondary|Median ACRn at Weeks 4, 8, 12, 16, 20, and 24|ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percent (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = minimum(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using last observation carried forward (LOCF). Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||percent change||Full Range|Median
1236445|NCT00611455|Secondary|Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
1236446|NCT00611455|Secondary|Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
1236447|NCT00611455|Secondary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, and 20|ITT Population|||participants|||Number
1236448|NCT00611455|Primary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.|||participants|||Number
1236449|NCT00611442|Secondary|The Number of Polyps Detected on Examination|The number of colon polyps detected during the colonoscopy.|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)||||number of polyps|||Number
1236450|NCT00611442|Secondary|Procedure Time|Procedure time refers to the total length of time required to complete the colonoscopy|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)||||minutes||Standard Deviation|Mean
1236451|NCT00611442|Secondary|Patient Satisfaction With the Prep Measured by 5 Point Likert Scale|The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.|measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)||||linkert scale (1-5)||Standard Deviation|Mean
1236452|NCT00611442|Primary|The Overall Cleanliness of the Prep as Measured by the Ottawa Scale|Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0–4), as well as a global 3-point rating for overall colonic fluid (0–2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0–3, a good preparation 4–6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11–14, depending on the amount of colonic fluid|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)||||Ottawa Score||Full Range|Mean
1236453|NCT00611403|Secondary|Change From Baseline in Goblet Cell Density of the Eyes at Month 6|Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).|Baseline, Month 6|Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).|||Cells per square millimeter (cells/mm^2)||Full Range|Median
1236493|NCT00610857|Secondary|1-year Overall Survival (OS)|1-year survival is the estimated probability of surviving one year expressed as a percent (probability of survival is not probability of dying).|Time from initial treatment date, up to 1 year||||percentage of patients||95% Confidence Interval|Number
1236973|NCT00607867|Primary|Change in %Hemoglobin A1c at 5 Weeks From Baseline|Hemoglobin A1c measured before and after 5 weeks on the diet|Baseline and 5 weeks after dietary intervention||||Change in % A1c at 5 weeks from baseli||Standard Error|Mean
1236454|NCT00611403|Secondary|Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6|Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).|Baseline, Month 6|Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
1236455|NCT00611403|Primary|Percentage of Patients With Clinical Success at Month 6|Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.|Month 6|Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of < 25 mm in the 3 central regions of the eye on Day 2.|||Percentage of Patients|||Number
1236456|NCT00611351|Secondary|Event-free Survival||2 years post transplant|Number of participants at 2 years that experienced event-free survival.|||Participants|||Count of Participants
1236457|NCT00611351|Secondary|Overall Survival||2 years post transplant|Count of participants is the number of participant alive at the 2 year post transplant time point.|||Participants|||Count of Participants
1236458|NCT00611351|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)||at day 100 post transplantation|count of participants represents number of participants with documented acute GVHD prior to day 100 post transplant.|||Participants|||Count of Participants
1236459|NCT00611351|Primary|Transplantation-related Mortality at 100 Days Post-transplantation||at the 100 days post-transplant|count of participants reflects number of participants not alive at 100 days post transplant.|||Participants|||Count of Participants
1236460|NCT00611325|Secondary|Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities|Number of patients with grade 3 or greater, treatment-related, non-hematologic toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|60 months||||participants|||Number
1236461|NCT00611325|Secondary|Radiographic Response Rate|The percentage of participants with a complete or partial response at any assessment as determined by the Macdonald criteria. A confirmation of response was not required. Per Macdonald criteria, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions, no new lesions and stable or decreasing steroid dose. Objective response =CR+PR. Tumor assessments were done at baseline and at the end of each 6 week treatment cycle, and overall best response was recorded.|60 months||||percentage of participants||95% Confidence Interval|Number
1236462|NCT00611325|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to the date of death. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause. Assessed up to 60 months.||||months||95% Confidence Interval|Median
1236463|NCT00611325|Secondary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression or death. Assessed up to 60 months.||||months||95% Confidence Interval|Median
1236464|NCT00611325|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the initiation of treatment without progression of disease. PFS was defined as the time from the initiation of treatment to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|6 months||||percentage of participants||95% Confidence Interval|Number
1236465|NCT00611247|Secondary|Toxicity Profile: Individual Subjects With Drug-related SAEs||12 months||||participants|||Number
1236466|NCT00611247|Secondary|Toxicity Profile: Total Number of Drug-related Serious Adverse Events||12 months||||events|||Number
1236467|NCT00611247|Primary|Response Rate (CR + CRi + LFS)|"Response determined per European LeukemiaNet response criteria:~CR = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 10e9/L; platelet count > 100 x 10e9/L; and independence of red cell transfusions.~CRi = all CR criteria except for residual neutropenia (< 1.0 x 10e9/L) or thrombocytopenia (< 100 x 10e9/L)].~Morphologic leukemia-free state (LFS) = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; with no hematologic recovery required.~Relapse = bone marrow blasts >5%; reappearance of blasts in the blood; or development of extramedullary disease."|up to 2 months||||participants|||Number
1236468|NCT00611130|Post-Hoc|Medication Compliance|Using retained urine samples and prior to unblinding, up to 12 specimens/ subject were analyzed for vigabatrin levels. Compliance assessment based on > or = 70% of urines in subjects assigned to vigabatrin having quantitative levels of vigabatrin indicaticative of taking drug within the last 24 hours of clinic visit.|Week 2, 4, 6 & 9-11|Completers were defined as those who attended the scheduled Week 13 visit or the third visit of Week 12 and who also had provided urines during Weeks 11 & 12.|||participants|||Number
1236469|NCT00611130|Primary|Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.|Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.|Week 13|intent-to-treat|||participants|||Number
1236494|NCT00610857|Secondary|Progression-free Survival (PFS)|Time from initial treatment date of to date of documented progression of disease progression (TTP)|Up to 44 months|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy|||months||95% Confidence Interval|Median
1236470|NCT00611026|Post-Hoc|Post-hoc Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a clinical investigation in which the participant was administered a product or medical device; the event does not necessarily need to have a causal relationship with the treatment or usage.|Baseline up to Week 12|Safety population included all participants who were randomized and received at least 1 dose of study treatment. N=number of participants with AEs noted in other unreviewed medical chart records as performed at other departments during the clinical trial but were not included as AEs in Case Report Forms; reported post-hoc.|||events|||Number
1236471|NCT00611026|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12|"HRQL domain and total raw score derived as sum of scores (6-point scale:~1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement."|Baseline, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1236472|NCT00611026|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12|Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement.|Baseline, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1236473|NCT00611026|Secondary|Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.|Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||participants|||Number
1236474|NCT00611026|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||participants|||Number
1236475|NCT00611026|Secondary|Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary|Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing baseline and respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percentage of participants|||Number
1236476|NCT00611026|Secondary|Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)|Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1236477|NCT00611026|Secondary|Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.|Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1236478|NCT00611026|Secondary|Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours|Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
1236479|NCT00611026|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours|Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||severe urgency episodes per 24 hours||Standard Error|Mean
1236480|NCT00611026|Secondary|Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)|Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
1236481|NCT00611026|Secondary|Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)|Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||episodes per 24 hours||Standard Error|Least Squares Mean
1236482|NCT00611026|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours|"UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is~1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100."|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
1236483|NCT00611026|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4|UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4|FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [LOCF] for placebo, tolterodine ER, and fesoterodine, respectively.|||episodes per 24 hours||Standard Error|Mean
1236484|NCT00611026|Secondary|Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
1236485|NCT00611026|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours|Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||nocturnal micturitions per 24 hours||Standard Error|Least Squares Mean
1236486|NCT00611026|Secondary|Percent Change From Baseline of Micturitions Per 24 Hours|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
1236487|NCT00611026|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||micturitions per 24 hours||Standard Error|Least Squares Mean
1236488|NCT00611026|Secondary|Change From Baseline in Mean Voided Volume Per Micturition|Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [Last Observation Carried Forward (LOCF)], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||mL||Standard Error|Mean
1236489|NCT00611026|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 12|Full analysis set (FAS): at least 1 dose of assigned treatment, data for at least 1 baseline or post-baseline efficacy assessment, and excluded 77 participants from 3 study sites with Good Clinical Practices (GCP) deviations (Fesoterodine N=30, Tolterodine ER N=31, Placebo N=16). Decision to exclude that data was made while the study was blinded.|||episodes per 24 hours||Standard Error|Mean
1236490|NCT00610987|Primary|Number of Participants With Total Wound Infections|The primary endpoint was infection.|at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.||||participants|||Number
1236495|NCT00610857|Primary|Best Objective Response Rate (BORR)|Intention to treat response rate is estimated by the proportion of patients with a best response of CR, PR, or SD by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.0|Up to 44 months|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks|||percentage of patients||90% Confidence Interval|Number
1236496|NCT00610740|Secondary|Number of Patients With Measurable Peripheral Vein Concentration of dFdC|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood|30, 60, 90 minutes post uterine vein sample||||Participants|||Number
1236497|NCT00610740|Primary|Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by local (uterine vein) gemcitabine hydrochloride concentration levels in blood|30 minutes post administration||||Participants|||Number
1236498|NCT00610740|Primary|Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.|30 Minutes After Application of Gemcitabine||||Participants|||Number
1236499|NCT00610727|Secondary|Dose Proportionality of Inhaled Prochlorperazine by Power Analysis|"Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|24 hours|Pharmacokinetic Population, n=40|||Slope of Power Regression||90% Confidence Interval|Geometric Least Squares Mean
1236500|NCT00610727|Secondary|Absolute Bioavailability of Inhaled Prochlorperazine|Absolute bioavailability of inhaled prochlorperazine via AUC infinity|24 hours|Bioavailability crossover subjects, n=8|||Fraction absorbed||90% Confidence Interval|Geometric Least Squares Mean
1236501|NCT00610727|Primary|Time to Peak (Tmax)|Time from dose to peak prochlorperazine concentration|24 hours|Pharmacokinetic Population|||hours||Inter-Quartile Range|Median
1236502|NCT00610714|Secondary|Overall Survival (Number of Deaths)|Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead|Date of randomization to death due to any cause||||Participants|||Number
1236503|NCT00610714|Secondary|Progression-free Survival (PFS) as Evaluated by RECIST|Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.|Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)||||Months||Full Range|Median
1236504|NCT00610714|Primary|Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)|Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.|Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)||||Participants|||Number
1236505|NCT00610701|Primary|Quadriceps Strength|measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose|(admission, 6 weeks, 3 months, 6 months) 1 year||||Nm||Standard Deviation|Mean
1236506|NCT00610688|Secondary|Birthweight of Newborn Infant|Growth of the Newborn Infant as Measured by Birthweight in grams.|Measured at birth.||||Grams||Standard Deviation|Mean
1236507|NCT00610688|Secondary|Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth|Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth|At delivery||||cm||Standard Deviation|Mean
1236508|NCT00610688|Primary|Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement|Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement|29 weeks|Intention to treat analysis.|||nmol/L||Standard Error|Mean
1236509|NCT00610675|Secondary|Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52|Satisfaction with Sleep Duration is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Units on a scale||Standard Deviation|Mean
1236510|NCT00610675|Secondary|Change From Baseline in Quality of Sleep Scale at Week 52|Quality of Sleep is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Units on a scale||Standard Deviation|Mean
1236511|NCT00610675|Secondary|Change From Baseline in Number of Awakenings at Week 52|Number of awakenings is a subjective number recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Awakenings||Standard Deviation|Mean
1236512|NCT00610675|Secondary|Change From Baseline in Wake Time After Sleep Onset at Week 52|Wake time after sleep onset (WASO) is, if the planned waking time is on or after the time of final awakening, as follows: total time from falling asleep to the time of planned wake up minus the total sleep time. If the planned waking time is before the time of final awakening then WASO is as follows: total time from falling asleep to the time of actual final awakening minus the total sleep time. All times were recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Minutes||Standard Deviation|Mean
1236513|NCT00610675|Secondary|Change From Baseline in Sleep Latency at Week 52|Sleep Latency (SL) is the time from when the participant went to bed up to the the time the participant actually fell asleep, recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Minutes||Standard Deviation|Mean
1236514|NCT00610675|Secondary|Change From Baseline in Total Sleep Time at Week 52|"Total Sleep Time (TST) is a subjective time recorded by the participant in an electronic sleep diary in response to the question How much time did you actually spend sleeping?. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the last observation carried forward (LOCF) method, where the last available assessments prior to the scheduled observation were averaged."|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Minutes||Standard Deviation|Mean
1236515|NCT00610675|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.|Up to 52 weeks|AST population consisting of all enrolled participants who received at least one dose of trial medication|||Participants|||Number
1236516|NCT00610675|Primary|Number of Participants With an Adverse Event|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.|Up to 57 weeks|All subjects treated (AST) population consisting of all enrolled participants who received at least one dose of trial medication|||Participants|||Number
1236517|NCT00610649|Secondary|Part 2: Change From Baseline in the MADRS|The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.|Baseline and end of treatment (Up to Day 28)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).|||score on a scale||Standard Deviation|Mean
1236518|NCT00610649|Secondary|Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS)|The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.|Baseline and end of treatment (Up to Day 16)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).|||score on a scale||Standard Deviation|Mean
1236519|NCT00610649|Primary|Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).|Up to the last dose of study drug (Up to 28 days)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
1236520|NCT00610649|Primary|Part 2: Number of Participants With AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 7 days following the last dose of study drug (Up to 35 days)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
1236521|NCT00610649|Primary|Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).|Up to the last dose of study drug (Up to 16 days)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
1236522|NCT00610649|Primary|Part 1: Number of Participants With Serious Adverse Events (SAEs)|An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to 30 days following the last dose of study drug (Up to 46 days)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
1236523|NCT00610649|Primary|Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning.|Up to 7 days following the last dose of study drug (Up to 23 days)|The All Subjects Treated (AST) population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
1236524|NCT00610532|Primary|Quantitative EEG Recordings||end of each treatment|No data was analyzed because the study was terminated by the investigators after they decided not to continue the project||||||
1236525|NCT00610441|Secondary|Computerized Cognition Assessment: Working Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of working memory (score range: -48 to 48), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for working memory.|||score on a scale||Standard Deviation|Mean
1236526|NCT00610441|Secondary|Computerized Cognition Assessment: Visual Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of visual memory (score range: -60 to 60), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for visual memory.|||score on a scale||Standard Deviation|Mean
1236527|NCT00610441|Secondary|Computerized Cognition Assessment: Verbal Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of verbal memory (score range: -60 to 60), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for verbal memory.|||score on a scale||Standard Deviation|Mean
1236528|NCT00610441|Secondary|Computerized Cognition Assessment: Sustained Attention|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of sustained attention (score range -120 to 120), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for sustained attention.|||score on a scale||Standard Deviation|Mean
1236529|NCT00610441|Secondary|Computerized Cognition Assessment: Reasoning|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reasoning (score range: -15 to 15), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reasoning.|||score on a scale||Standard Deviation|Mean
1236530|NCT00610441|Secondary|Computerized Cognition Assessment: Reaction Time|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reaction time (lowest time possible is 0 msec), with a lower reaction time indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reaction time.|||msec||Standard Deviation|Mean
1236531|NCT00610441|Secondary|Computerized Cognition Assessment: Speed of Processing|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of speed of processing (score range: -1000 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for speed of processing.|||score on a scale||Standard Deviation|Mean
1236532|NCT00610441|Secondary|Computerized Cognition Assessment: Executive Functioning|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of executive functioning (score range: -200 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for executive functioning.|||score on a scale||Standard Deviation|Mean
1236558|NCT00610311|Secondary|Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells.|T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.||||||
1236533|NCT00610441|Secondary|Computerized Cognition Assessment: Composite Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of composite memory (score range: -120 to 120), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for composite memory.|||score on a scale||Standard Deviation|Mean
1236534|NCT00610441|Secondary|Computerized Cognition Assessment: Complex Attention|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of complex attention (score range: 0 to 250), with a lower score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for complex attention.|||score on a scale||Standard Deviation|Mean
1236535|NCT00610441|Secondary|Computerized Cognition Assessment: Cognitive Flexibility|Cognition was assessed by a computerized cognitive testing (©CNS Vital Signs, Chapel Hill, NC) battery consisting of neuropsychological tests that measure the cognitive domain of cognitive flexibility (score range: -200 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for cognitive flexibility.|||score on a scale||Standard Deviation|Mean
1236536|NCT00610441|Secondary|Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score|The TASS is a participant-administered scale to assess study drug effects in the evening. Participants respond to 18 questions about ADHD symptoms, with scores from 0=Not at all to 3=Severe. Total scores can range from 0 to 54, with a higher score indicating more severe ADHD symtoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline TASS efficacy assessment.|||score on a scale||Standard Deviation|Mean
1236537|NCT00610441|Secondary|Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score|The QIDS-C is a clinician-administered rating scale to measure the severity of depressive symptoms within the 9 DSM-IV major depression disorder symptom (MDD) domains: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes. There is one score (0=none to 3=severe) for each of the of the 9 domains. The total score is obtained by adding the scores for each of the 9 symptom domains. QIDS-C total scores can range from 0 to 27, with a higher score indicating more severe depression. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline QIDS-C efficacy assessment.|||score on a scale||Standard Deviation|Mean
1236538|NCT00610441|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score|The PSQI is a participant-rated scale to assess the quality of sleep. The PSQI consists of 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score can range from 0=better (i.e., 0 times per month) to 3=worse (i.e., 3 or more times per week). The sum of these 7 component scores yields one total score with a range of 0 (better) to 21 (worse). A total PSQI score <=5 is associated with good sleep quality; a total score >5 is associated with poor sleep quality. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline PSQI efficacy assessment.|||score on a scale||Standard Deviation|Mean
1236539|NCT00610441|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score|The ESS is an 8-item scale used to assess sleepiness. The test consists of a list of 8 situations in which participants rate their tendency to become sleepy on a scale of 0=Would never doze to 3=High chance of dozing. The scores for each of the 8 situations are added to create a total score on a scale with a range from of 0 to 24. A higher score indicates a greater degree of sleepiness. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline ESS efficacy assessment.|||score on a scale||Standard Deviation|Mean
1236540|NCT00610441|Secondary|Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores|The CGI-I is a 7-point clinician-rated scale for assessing the global improvement of ADHD. Scores could range from 1=Very much improved to 4=No change to 7=Very much worse, with a lower score indicating the most improvement. Analysis of CGI-I was performed using a proportional odds model. For statistical analyses, CGI-I assessments were condensed to one assessment of improvement per treatment period by taking the worst improvement score at the second and third visits within a treatment period.|Days 14-21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-I efficacy assessment.|||percentage of participants|||Number
1236559|NCT00610311|Primary|Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)|Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.|4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met||||Participants|||Number
1236541|NCT00610441|Secondary|Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores|The CGI-S is a 7-point clinician-rated scale for assessing the global severity of ADHD. Scores could range from 1=Normal, not at all ill to 7=Among the most extremely ill, with a higher score indicating more severe illness. Categorization was as follows: 1=Normal, not at all ill and Borderline mentally ill; 2=Mildly ill; 3=Moderately ill and 4=Markedly ill, Severely ill and Among the most extremely ill patients, with a higher category indicating more severe illness. Analysis of CGI-S was performed using a proportional odds model. For statistical analyses, CGI-S assessments were condensed to one assessment of severity per treatment period by taking the most severe score at the second and third visits within a treatment period.|Days 14-21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-S efficacy assessment.|||percentage of participants|||Number
1236542|NCT00610441|Secondary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.|Up to last dose of study drug (Up to 56 days)|The AST population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).|||percentage of participants|||Number
1236543|NCT00610441|Secondary|Percentage of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.|Up to 7 days after last dose of study drug (Up to 63 days)|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).|||percentage of participants|||Number
1236544|NCT00610441|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in AISRS Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the DSM-IV diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.|Baseline and Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.|||percentage of participants|||Number
1236545|NCT00610441|Secondary|Percentage of Participants With at Least a 30% Reduction From Baseline in AISRS Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.|Baseline and Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.|||percentage of participants|||Number
1236546|NCT00610441|Primary|Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.|Baseline (BL) and Day 7, Day 14, Day 21|The Intent-to-Treat (ITT) population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline AISRS efficacy assessment. Results are reported by the study drug being administered at time of assessment and not by randomly assigned sequence.|||score on a scale||Standard Deviation|Mean
1236547|NCT00610428|Secondary|Survival Analysis for Time to Pain Relief|Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition|from treatment (time = 0) to 2 hours post treatment|ITT Population by Treatment Assigned|||minutes to pain relief||Standard Error|Mean
1236548|NCT00610428|Primary|Headache Pain Relief at 2 hr Post-dose by 2-point Definition|patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain|2 hours after treatment|ITT Population with LOCF|||Participants|||Count of Participants
1236560|NCT00610207|Primary|Fistula Closure (Tract Based)|"Fistula closure is defined as absence of drainage at the external fistula opening.~An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient."|12 months|Three single tract fistula patients were lost to follow-up and were excluded from the analysis.|||tracts|Participants||Number
1236561|NCT00610207|Primary|Fistula Closure (Patient Based)|Fistula closure is defined as absence of drainage at the external fistula opening.|12 months|Three single tract fistula patients were lost to follow-up and were excluded from the analysis.|||participants|||Number
1236549|NCT00610363|Secondary|Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
1236550|NCT00610363|Secondary|Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 154) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 154), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
1236551|NCT00610363|Secondary|Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per month per participant was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
1236552|NCT00610363|Secondary|Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per participant was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
1236553|NCT00610363|Secondary|Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days).|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||number of gout flares||Standard Deviation|Mean
1236554|NCT00610363|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||percentage of participants|||Number
1236555|NCT00610363|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Number of gout flares per participant||Standard Deviation|Mean
1236556|NCT00610311|Secondary|Number of Participants Who Develop Anti-mouse T Cell Receptor (TCR) Antibodies|Blood samples are collected from the patient and an immunological test is conducted in the laboratory to determine if the patient has generated antibodies against the mouse T-cell receptor which is part of the anti-gp100 cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.||||||
1236557|NCT00610311|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18.5 months||||Participants|||Number
1236733|NCT00608881|Secondary|Change in Independence Scale Score From Baseline to Month 60|The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.|Baseline and Month 60||||units on a scale||Standard Error|Mean
1236562|NCT00610168|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1236563|NCT00610168|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0–30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1236564|NCT00610168|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0–3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Subjects|||Number
1236565|NCT00610168|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0–3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Subjects|||Number
1236566|NCT00610168|Secondary|Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL.|At Month 1|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||Subjects|||Number
1236567|NCT00610168|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1236568|NCT00610168|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||Subjects|||Number
1236569|NCT00610168|Secondary|Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Concentrations are presented as international units per millilitre (IU/mL).|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1236570|NCT00610168|Primary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs|The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.|At Month 1|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||Subjects|||Number
1236571|NCT00610168|Primary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs|The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||Subjects|||Number
1236572|NCT00610155|Secondary|Doleur Neuropathic 4 (DN4) Score|DN4 questionnaire provides a simple diagnosis of Neuropathic pain (NeP) by asking for yes/no answers to 4 questions (10 sub questions in total). Each question was scored on a scale of 0 (No) and 1 (Yes). Total score was calculated as sum of the 10 individual questions. Total score range 0-10, higher score indicated more neuropathic pain.|Day -35|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
1236573|NCT00610155|Secondary|Present Pain Intensity Score (PPIS)|Participants answered: “Please rate your pain from 0-10 that best describes the intensity of pain right now”. PPIS assessed on 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).|Day 8, 22, 36|FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1236574|NCT00610155|Secondary|Daily Pain Score|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning using 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). The daily pain scores for an average of the last 7 days and an average of last 3 days were calculated.|Day -35 through Day 36|FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1236575|NCT00610155|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicate a greater intensity of pain.|Baseline (Day -7), Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
1236576|NCT00610155|Secondary|Pain Catastrophising Scale (PCS)|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores indicate greater extent of pain catastrophizing.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
1236577|NCT00610155|Secondary|State and Trait Anxiety Questionnaire|Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant report how they feel “right now at this moment” for state anxiety and how they “generally” feel for trait anxiety. The “state” items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very much so). The “trait” items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 20-80 for each scale. Higher scores indicate more impaired participants.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
1236578|NCT00610155|Secondary|Beck Depression Inventory (BDI)|BDI is a 21 item participant rated inventory evaluating depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicate more depression.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
1236579|NCT00610155|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
1236580|NCT00610155|Primary|Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions|Continuous ASL sequence fMRI imaging modality assessing brain activation signals across the whole brain and in defined ROI to assess effects of evoked pain along with changes in regional cerebral blood flow (rCBF). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG.|Day 8, 22, 36|Data was not analyzed since these methods were not technically robust enough to make any clear conclusions.||||||
1236581|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS)|BOLD brain activation signals in pre-defined ROI in response to checkerboard visual stimuli (flashing at 2 Hz). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only.|Day 8, 22, 36|For VIS, based on preliminary analysis results, it was not considered significant to collect data according to Investigator's opinion.||||||
1236582|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)|BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.|||percent signal change||Standard Error|Least Squares Mean
1236583|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)|BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.|||percent signal change||Standard Error|Least Squares Mean
1236599|NCT00609804|Secondary|Overall Response Rate|The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|All patients on study|||participants|||Number
1236584|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)|BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex([AIC_L ],[AIC_R]);left,right mid-insular cortex([MIC_L],[MIC_R]);left,right posterior insular cortex([PIC_L],[PIC_R]);left,right amygdala([Amyg_L],[Amyg_R]);primary,secondary somatosensory cortex([S1],[S2]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.|||percent signal change||Standard Error|Least Squares Mean
1236585|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain|BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS).|Day 8, 22, 36|Data not available to report, as BOLD brain activation signals in whole brain were obtained as specific Contrast Parameter Estimates (COPE) images only, as per planned analysis.||||||
1236586|NCT00610129|Primary|Objective Response Rate (ORR)|in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.|2 years||||participants|||Number
1236587|NCT00609986|Secondary|Severe Hyperglycemia|Blood glucose greater than 350 mg/dl.|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.|||participants|||Number
1236588|NCT00609986|Primary|Acute/Active Rejection|Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology.|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.|||participants|||Number
1236589|NCT00609986|Secondary|Severe Hypoglycemia|Blood glucose less than 40 mg/dl|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.|||participants|||Number
1236590|NCT00609986|Primary|Delayed Graft Function|Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl.|10 days|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.|||participants|||Number
1236591|NCT00609973|Secondary|Endoscopic Recurrence Under Postoperative Treatment With Study Medication at 6 Months||6 months|Endoscopy 6 months, Intention-to-Treat analysis, patients not undergoing endoscopy were assumed to have endoscopic recurrence|||participants|||Number
1236592|NCT00609973|Primary|Safety and Tolerability of Ciprofloxacin|Adverse events (AE) Discontinuation of study drug due to probably study drug related AE|6 Months|Intention to Treat analysis.Adverse events (AE), which were classified as probably or possibly related to the study drug.|||Adverse events|||Number
1236593|NCT00609947|Primary|Major Adverse Cardiac Events (MACE) Rate|Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery.|12 months post-procedure|"12-month MACE Rate was compared to a 20% performance goal.~1st 97 subjects enrolled and implanted with 2.25mm stents~1st 39 subjects enrolled and implanted with 2.5mm stents~1st 40 subjects enrolled and implanted with 2.75mm stents~A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"|||Percentage||95% Confidence Interval|Number
1236594|NCT00609947|Primary|In-segment Percent Diameter Stenosis at 8 Months Post-procedure|In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD – Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).|8 months post-procedure|The primary analysis sample consisted of 176 subjects (ITT) including the first 97 subjects with 2.25 mm, 39 subjects with 2.50 mm and 40 subjects with 2.75mm stents who met the study entry criteria, signed the written informed consent, and were enrolled in the trial.|||percent diameter stenosis||95% Confidence Interval|Mean
1236595|NCT00609869|Secondary|Median Time to Treatment Failure (TTF)|The time from start of therapy to death, Progressive Disease (PD) or initiation of next therapy. PD: at least one of the NCI-WG criteria of Group A or Group B has to be met.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants|||months||95% Confidence Interval|Median
1236596|NCT00609869|Secondary|Clinical Benefit Rate|The ORR rate plus Stable Disease (SD). NCI-WG: SD is the absence of progressive disease (PD) and failure to achieve at least a PR; PD: at least one of the criteria of Group A or Group B has to be met.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants|||percentage of participants|||Number
1236597|NCT00609869|Primary|Overall Response Rate (ORR)|The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants|||percentage of participants|||Number
1236598|NCT00609804|Secondary|Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability|Defined as the number of participants with treatment-emergent grade 3/4 adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v3.0|18 months|All patients on study|||participants|||Number
1236600|NCT00609804|Primary|Progression-free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|All patients on study|||months||95% Confidence Interval|Median
1236601|NCT00609765|Secondary|The Number of Participants With Radiographic Response|Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.|2 years|||||||
1236602|NCT00609765|Primary|Number of Participants With Progression Free Survival (PFS) at 12 Months|We planned to calculate the One Year Progression Free Survival rate. The event for PFS analyses was the first occurrence of disease progression or death and patients who did not progress or died would be censored at the date of last tumor evaluation (e.g. one-year).|12 months|Per protocol at 12 months||||||
1236603|NCT00609739|Secondary|Patients Who Relapsed|Number of patients whose disease relapsed.|1 Year||||participants|||Number
1236604|NCT00609739|Secondary|Patients With Graft-Versus-Host-Disease|Number of patients who exhibited acute and/or chronic graft-versus-host disease.|Up to 30 Days Post Study Treatment||||participants|||Number
1236605|NCT00609739|Secondary|Patients With Regimen-Related Toxicity|Number of patients with adverse events related to treatment.|Up to 30 Days Post Study Treatment||||participants|||Number
1236606|NCT00609739|Primary|Disease-free Survival|Number of patients who were free of disease and alive at 1 year.|1 year||||Participants|||Number
1236607|NCT00609674|Secondary|Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])|RQLQ(S) is a 28-item, self-administered, disease-specific (allergic rhinitis), quality of life instrument that assesses quality of life over a 1-week interval. Each question is scored from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment on quality of life. RQLQ(S): Possible score ranges from 0 to 6. Change from baseline is calculated as the score at the endpoint minus the score at baseline.|Baseline and Week 4|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236608|NCT00609674|Secondary|Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF|PNIF: Objective measure of nasal airway flow obstruction.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Liters/minute||Standard Error|Least Squares Mean
1236609|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness|The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)||||Points on a scale||Standard Error|Least Squares Mean
1236610|NCT00609674|Secondary|Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness.|The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236611|NCT00609674|Secondary|Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS|The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). AM, pre-dose iTOSS: sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||percent change||Standard Error|Least Squares Mean
1236612|NCT00609674|Secondary|Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS|The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236613|NCT00609674|Secondary|Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)|The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236614|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing.|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236775|NCT00608517|Secondary|Number of Participants With Chronic Graft Versus Host Disease (GVHD)|As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement|100 days||||participants|||Number
1236615|NCT00609674|Secondary|Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236616|NCT00609674|Secondary|Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). AM, pre-dose iTNSS: sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score range of 0 to 12. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||percent change||Standard Error|Least Squares Mean
1236617|NCT00609674|Secondary|Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236618|NCT00609674|Secondary|Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS|TNSS = the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236619|NCT00609674|Primary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|Intent-to-Treat (ITT) Population: all randomized subjects who received at least one dose of study drug|||Points on a scale||Standard Error|Least Squares Mean
1236620|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)|The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness, where each symptom is scored on a scale of 0 (none) to 3 (severe); total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236621|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)|The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe). Change from baseline is calculated as the score over the entire treatment period minus the score at baseline. TNSS: Total possible score ranges from 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
1236622|NCT00609622|Secondary|Change From Baseline in Functional Assessment of Cancer Treatment – Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score|FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.|Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
1236623|NCT00609622|Secondary|Change From Baseline in Functional Assessment of Cancer Treatment – Colorectal (FACT-C) Score|FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.|Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)|FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here “n” signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||Units on a scale||Standard Deviation|Mean
1236776|NCT00608517|Secondary|Overall Survival|Overall survival at 1 year|1 year||||participants|||Number
1236624|NCT00609622|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115|Data was not analyzed due to early study termination.||||||
1236625|NCT00609622|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1236626|NCT00609622|Secondary|Two Year Survival Probability|Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)|Data was not analyzed due to early study termination.||||||
1236627|NCT00609622|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)|Data was not analyzed due to early study termination.||||||
1236628|NCT00609622|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
1236629|NCT00609622|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
1236630|NCT00609609|Post-Hoc|Non-relapse Mortality (NRM) at 6 Months|Percentage of participants at 6 months whose deaths were without relapse/recurrence.|6 months||||percentage of participants||95% Confidence Interval|Number
1236631|NCT00609609|Post-Hoc|Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56|Percentage meeting steroid milestone who were alive, in remission and did not have GVHD progression before Day 28 or Day 56.|Up to day 56||||percentage of participants|||Number
1236632|NCT00609609|Primary|Day 56 Treatment Success|Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on >1 mg/kg/d of methylprednisolone equivalent at 1 month. 2) Patient still on > 0.5 mg/kg/d of methylprednisolone equivalent at 2 months; 3) Death from GVHD. Definition of Treatment Success: Participants not defined above in Treatment Failure definition. Baseline biopsy with Acute GVHD assessed weekly until last ECP procedure (anticipated Day 63). At 6 months follow up with a phone call for survival and GVHD status.|Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly.||||percentage of participants|||Number
1236633|NCT00609518|Secondary|Progression-free Survival (PFS)|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.|Randomization (≤4 weeks from baseline visit) to 12 months after randomization|Qualified Intent to Treat (Q-ITT)|||months||95% Confidence Interval|Median
1236634|NCT00609518|Secondary|Overall Survival|Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.|Randomization (≤4 weeks from baseline visit) to 12 months after randomization|Qualified Intent to Treat (Q-ITT)|||months||95% Confidence Interval|Median
1236635|NCT00609518|Secondary|Proportion of Participants With Best Overall Tumor Response (Response Rate)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response.|Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.|Qualified Intent to Treat (Q-ITT)|||proportion of patients||95% Confidence Interval|Mean
1236636|NCT00609518|Primary|Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity|"Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows:~Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section."|From first dose of treatment to last dose of treatment plus 30 days|Qualified Intention to Treat (Q-ITT)|||participants|||Number
1236637|NCT00609492|Secondary|Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1236638|NCT00609492|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A|A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236639|NCT00609492|Secondary|Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1236640|NCT00609492|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes|A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236641|NCT00609492|Secondary|Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs)|Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
1236642|NCT00609492|Secondary|Antibody Titers Against Anti-polio Type 1, 2 and 3|Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1236643|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3)|A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236644|NCT00609492|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations < 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236664|NCT00609492|Primary|Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)|Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Subjects|||Number
1236777|NCT00608517|Secondary|Number of Subjects With All-cause Mortality|Death from any cause at 100 days|at 100 days||||participants|||Number
1236645|NCT00609492|Secondary|Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1236646|NCT00609492|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236647|NCT00609492|Secondary|Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP)|Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1236648|NCT00609492|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL|The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236649|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236650|NCT00609492|Secondary|Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)|Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1236651|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)|A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236652|NCT00609492|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1236653|NCT00609492|Secondary|Number of Seropositive Subjects for Protein D Antibodies (Anti-PD)|A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236778|NCT00608517|Secondary|Number of Participants Who Relapsed at 1 Year||1 year||||participants|||Number
1236654|NCT00609492|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1236655|NCT00609492|Secondary|Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A|A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236656|NCT00609492|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1236657|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes|A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236658|NCT00609492|Secondary|Number of Seropositive Subjects for Anti-pneumococcal Serotypes|A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1236659|NCT00609492|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1236660|NCT00609492|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the active phase of the study (Month 0 to Month 1)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1236661|NCT00609492|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within 31-days (Day 0-30) after booster vaccination|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1236662|NCT00609492|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Subjects|||Number
1236663|NCT00609492|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Subjects|||Number
1236665|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 72 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain)."|Baseline to 72 hours after first intake of study drug|Intention to treat (ITT) and Last Observation Carried Forward (LOCF).|||units||Standard Deviation|Mean
1236666|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain)."|Baseline to 24 hours after first study drug intake|Intention to treat (ITT)and Last Observation Carried Forward (LOCF).|||units||Standard Deviation|Mean
1236667|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 12 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain)."|Baseline to 12 hours after first study drug intake|Intention to treat (ITT) and Last Observation Carried Forward (LOCF).|||units||Standard Deviation|Mean
1236668|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 6 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain)."|Baseline to 6 hours after intake of first study drug|Intention to treat(ITT) and Last Observation Carried Forward (LOCF).|||units||Standard Deviation|Mean
1236669|NCT00609466|Secondary|Total Pain Relief (TOTPAR)|Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug. The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain? None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4. The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192. The higher the value the better the pain relief.|Baseline to 48 hours after first study drug intake|Intention to treat(ITT)and Last Observation Carried Forward (LOCF)|||units||Standard Deviation|Mean
1236670|NCT00609466|Secondary|Number of Participants Using Rescue Medication|Number of participants who used at least one dose of rescue medication during the 72 hour double blind period.|Baseline up to 72 hours after first study drug intake|Intention to treat (ITT) and Last Observation Carried Forward (LOCF)|||participants|||Number
1236671|NCT00609466|Primary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.|"Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain)."|Baseline value to 48 hours after first study drug intake.|Intention to Treat - randomized subjects who were dosed and had a baseline pain intensity assessment. Last observation carried forward was used.|||units||Standard Deviation|Mean
1236672|NCT00609362|Secondary|Change in Gene Expression in Bone Marrow and Fat Cells||Before and after treatment|||||||
1236673|NCT00609362|Secondary|Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups|C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).|At baseline and after 14 weeks of treatment||||Percent change from baseline||Standard Deviation|Mean
1236674|NCT00609362|Secondary|Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.|Bone marrow fat was measured using MRI spectroscopy providing a measure of bone marrow fat as a ratio to bone marrow water, the lipid-water ratio (LWR)|Measured at baseline and after 14 weeks of treatment||||Percent change in LWR||Standard Deviation|Mean
1236675|NCT00609362|Primary|Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group|Difference in percent change in bone mineral density (BMD) from baseline to 14 weeks between the rosiglitazone group and the placebo group. BMD was assesed using dual x-ray absorptiometry (DXA)|BMD measured at baseline and after 14 weeks of treatment||||Percent change from baseline||Standard Deviation|Mean
1236676|NCT00609336|Secondary|Percent of Patients Surviving at Annual Intervals||5 years||||percentage of participants|||Number
1236677|NCT00609336|Secondary|Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to 26 weeks after surgery (the end of adjuvant chemotherapy)|All eligible patients|||occurrence of toxicities|||Number
1236678|NCT00609336|Secondary|Surgical Completion Rate and Complication Rate||Up to 6 weeks following the completion of chemoradiotherapy|all eligible patients|||Participants|||Count of Participants
1236679|NCT00609336|Secondary|CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy|Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.|Up to 26 weeks after surgery|Biomarker data not collected.||||||
1236700|NCT00609271|Primary|Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group|Predicted mean difference from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||kg||95% Confidence Interval|Mean
1236680|NCT00609336|Secondary|Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy|The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90|Up to 7 years|all eligible patients with non-missing data|||Participants|||Count of Participants
1236681|NCT00609336|Secondary|Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy|Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Up to 7 years|Clinical response not collected.||||||
1236682|NCT00609336|Secondary|Median Recurrence Free Survival Following Pancreaticoduodenectomy|The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.|From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years|Among eligible patients who received surgery|||months||95% Confidence Interval|Median
1236683|NCT00609336|Secondary|Percent of Patients Surviving at 5 Years|Kaplan-Meier estimate of overall survival at 5 years|Up to 5 years|all eligible patients|||percentage of eligible pts alive|||Number
1236684|NCT00609336|Primary|Median Overall Survival of Patients With Adenocarcinoma of the Pancreas|Time at which Kaplan-Meier estimate of overall survival drops below 50%|5 years|All eligible patients|||months||95% Confidence Interval|Median
1236685|NCT00609271|Primary|Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group|Mean Difference in 10-y Framingham Risk Score predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 Months||||% risk of developing CVD in next 10 yrs||95% Confidence Interval|Mean
1236686|NCT00609271|Primary|Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group|Mean Difference in Serum Creatinine Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 Months||||µmol/L¶||95% Confidence Interval|Mean
1236687|NCT00609271|Primary|Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group|Mean Difference in C-reactive Protein Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values|12 Months||||nmol/L||95% Confidence Interval|Mean
1236688|NCT00609271|Primary|Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group|Mean Difference in Serum Insulin Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||pmol/L||95% Confidence Interval|Mean
1236689|NCT00609271|Primary|Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group|Mean Difference in Plasma Glucose Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||"mmol/L||"||95% Confidence Interval|Mean
1236690|NCT00609271|Primary|Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group|Mean Difference in Diastolic Blood Pressure predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values|12 Months||||mm Hg||95% Confidence Interval|Mean
1236691|NCT00609271|Primary|Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mm Hg||95% Confidence Interval|Mean
1236692|NCT00609271|Primary|Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mmol/L||95% Confidence Interval|Mean
1236693|NCT00609271|Primary|Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||ratio||95% Confidence Interval|Mean
1236694|NCT00609271|Primary|Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mmol/L||95% Confidence Interval|Mean
1236695|NCT00609271|Primary|Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mmol/L||95% Confidence Interval|Mean
1236696|NCT00609271|Primary|Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mmol/L||95% Confidence Interval|Mean
1236697|NCT00609271|Primary|Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||cm||95% Confidence Interval|Mean
1236698|NCT00609271|Primary|Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group|Mean Difference in Fat Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||% body weight that is fat mass||95% Confidence Interval|Mean
1236699|NCT00609271|Primary|Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group|Mean Difference in Lean Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||% of body weight that is lean mass||95% Confidence Interval|Mean
1236701|NCT00609245|Primary|Difference in SPR During Placebo and VPA Infusions|"standard photosensitive range (SPR) Each participant is exposed to intermittent photic stimulation at 14 predetermined frequencies in order to detect changes in response around typical upper and lower frequency thresholds (e.g., 2 Hz, 5 Hz, 8Hz, 10 Hz, etc.). Each flash frequency that elicits a photosensitive response is considered one step, and the result is transformed into a metric called the standardized photosensitive range (SPR). The SPR ranges from 0 to 14, where each point represents the number of flash frequencies that elicited a photosensitive response."|At the start of EEG monitoring/drug infusion, and on an hourly basisfor 12 hours|1 patient did not complete infusion of Valproic Acid due to Adverse Event. This patient was not included in final analysis.|||standard photosensitive range (SPR)||Full Range|Mean
1236702|NCT00609167|Secondary|Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant|Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.|After 4 cycles of treatment|At the time of publication, data was available on 18 patients for group 2.|||participants|||Number
1236703|NCT00609167|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Every cycle during treatment (up to 12 cycles)||||participants|||Number
1236704|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles|"Response that was confirmed on 2 consecutive evaluations after 12 cycles of treatment.~Criteria for CR, nCR, VGPR and PR are defined in prior outcomes."|After 12 cycles of treatment|No participants received 12 cycles of treatment; therefore, all participants are non-evalualble.|||participants|||Number
1236705|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles|"Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment.~Criteria for CR, nCR, VGPR and PR are defined in prior outcomes."|After 8 cycles of treatment|Participants who received 8 cycles of treatment were analyzed.|||participants|||Number
1236706|NCT00609167|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.|Duration of study (up to 12 cycles)|Participants who achieved a partial response(PR) or better were evaluable for this analysis.|||months||95% Confidence Interval|Median
1236707|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles|"Response that was confirmed on 2 consecutive evaluations after 8 months of treatment.~CR, nCR and VGPR as defined in the primary outcome.~Partial Response(PR): >=50% reduction in serum M-component and/or~Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|4 cycles|Participants who received 4 cycles of treatment were analyzed.|||participants|||Number
1236708|NCT00609167|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause.|From date of registration until death (up to 5 years)||||months||95% Confidence Interval|Median
1236709|NCT00609167|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~Bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|up to 5 years||||months||95% Confidence Interval|Median
1236710|NCT00609167|Primary|Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment|"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow."|After 4 months of treatment||||participants|||Number
1236711|NCT00609128|Primary|Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion|"Outcome:~The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay.~Eosinophils in eosinophils / square cm measured."|1 week for tear collection, tears stored at - 80 C until used||||eosinophils/square cm epithelial cells||Standard Error|Mean
1236712|NCT00608985|Secondary|Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)|sLSO was the self-reported time to fall asleep as reported in the sleep diary|From baseline to Week 1&2|All treated patients with available data|||minutes||95% Confidence Interval|Median
1236713|NCT00608985|Secondary|Change From Baseline to Day 15&16 in LPS|LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG|From baseline to Day 15&16|All treated patients|||minutes||95% Confidence Interval|Median
1236714|NCT00608985|Secondary|Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)|LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG|From baseline to Day 1&2|All treated patients|||minutes||95% Confidence Interval|Median
1236715|NCT00608985|Primary|Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)|sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2|From baseline to Week 1&2|All treated patients with available data|||minutes||95% Confidence Interval|Median
1236717|NCT00608985|Primary|Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)|"WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.~For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16"|From baseline to Day 1&2|All treated patients|||minutes||95% Confidence Interval|Median
1236718|NCT00608959|Primary|Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs)|Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion.|Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days.|intravenous (IV) catheters were removed for culture from 5 subjects at 72 hours, 10 subjects at 5 days, and 10 subjects at 7 days.|||participants|||Number
1236719|NCT00608959|Primary|Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days|Change in the mean number of skin bacterial counts (log 10 CFU/cm2)which was calculated by subtracting log10 CFU/cm2 at 7 days (one sample per site per subject per timepoint) from log10CFU/cm2 at 0 hours in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint.|Prior to first application (0 hours) to 7 days post application.|In Part 2 of the study 25 subjects had only omiganan applied to sites across the upper chest or abdomen.Swab cultures were obtained over a period of 7 days at protocol-specified times|||log 10 CFU/sq. cm||Standard Deviation|Mean
1236720|NCT00608959|Primary|Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours|Change in the mean number of skin bacterial counts (CFU/cm2) which was calculated by subtracting log10 CFU/cm2 at 72 hours (single sample per subject per timepoint) from the log10 CFU/cm2 at 0 hours (baseline) in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint.|Prior to first application (0 hours) to 72 hours post application|ITT set consists of all subjects who received at least one study treatment and had data available at 72 hours.|||log 10 CFU/cm sq||Standard Deviation|Mean
1236721|NCT00608907|Primary|Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours||Cycle 3 day 14 (72 hours post last dose)|Pharmacokinetic (PK) evaluable population, include all subjects completed 3 cycles of treatment and all PK assessments during the first 3 cycles of the study.|||ng*h/mL||Standard Deviation|Mean
1236722|NCT00608881|Secondary|Number Completing Study at Assigned Dosage Level||5 years||||participants completing study on drug|||Number
1236723|NCT00608881|Secondary|Time to a Three-Point Decline in TFC Score or Death|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years||||days to event||95% Confidence Interval|Median
1236724|NCT00608881|Secondary|Time to a Two-Point Decline in TFC Score or Death|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years||||days to event||95% Confidence Interval|Median
1236725|NCT00608881|Secondary|Change in Stroop Interference Test - Interference From Baseline to Month 60|Stroop Interference Test - interference score is the total number of correct items identified in 45 seconds and reflects an executive measure of inhibitory ability.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236726|NCT00608881|Secondary|Change in Stroop Interference Test - Word Reading From Baseline to Month 60|Stroop Interference Test - word reading score is the total number of correct words read in 45 seconds and reflects processing speed.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236727|NCT00608881|Secondary|Change in Stroop Interference Test - Color Naming From Baseline to Month 60|Stroop Interference Test - color naming score is the total number of correct colors identified in 45 seconds and reflects processing speed.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236728|NCT00608881|Secondary|Change in Verbal Fluency Test From Baseline to Month 60|The verbal fluency test is typically considered a measure of executive function. The score is the number of correct words produced across three 1-minute trials.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236729|NCT00608881|Secondary|Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60|The SDMT assesses attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The score is the number of correctly paired abstract symbols and specific numbers in 90 seconds with higher scores indicating better cognitive functioning.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236730|NCT00608881|Secondary|Change in Behavioral Frequency x Severity Score From Baseline to Month 60|The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. The total score is the sum of the product of the individual behavioral frequency and severity items (range 0-176) with higher scores representing more severe behavioral impairment.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236731|NCT00608881|Secondary|Change in Behavioral Frequency Score From Baseline to Month 60|The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. A total score was calculated by summing up all the individual behavioral frequency items (range 0-56) with higher scores representing more severe behavioral impairment.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236732|NCT00608881|Secondary|Change in Total Motor Score From Baseline to Month 60|The motor section of the Unified Huntington's Disease Rating Scale (UHDRS) assesses motor features of Huntington disease with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor score is the sum of all the individual motor ratings, with higher scores (124) indicating more severe motor impairment than lower scores. The score ranges from 0 to 124.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236779|NCT00608517|Secondary|Number of Participants With Acute Graft-versus-host Disease (GVHD)|Participants who exhibit acute GVHD.|100 days||||participants|||Number
1236734|NCT00608881|Secondary|Change in Functional Checklist Score From Baseline to Month 60|"The functional assessment checklist includes 25 questions about common daily tasks. A score of 1 is given for each yes reply and a score of 0 is given for each no reply (scale range is 0-25). Higher scores indicate better functioning."|Baseline and Month 60||||units on a scale||Standard Error|Mean
1236735|NCT00608881|Secondary|Change in Total Functional Capacity (TFC) Score From Baseline to Month 60|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
1236736|NCT00608881|Primary|Joint Rank (Combination of Time to Death (for Subjects Who Died) and Change in Total Functional Capacity Score (TFC) From Baseline to Month 60 (for Subjects Who Survived))|The primary outcome variable at the start of the trial was the change in TFC score from baseline to Month 60. The Data and Safety Monitoring Board recommended to the trial leadership that they reconsider how they accommodate missing data from subjects who die in their primary analysis of the change in TFC score. Based on these recommendations, the trial leadership changed the primary analysis to that of a joint rank approach. TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years||||rank||Standard Deviation|Mean
1236737|NCT00608868|Secondary|Adverse Event|An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)||||participants|||Number
1236738|NCT00608868|Secondary|Overall Survival||Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death.|||||||
1236739|NCT00608868|Secondary|Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)|"Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0~4 scale (0=not at all to 4=very much). A possible score was 0~28.~The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L.~The percentage of patients who showed improvement is reported."|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)||||percentage of participants|||Number
1236740|NCT00608868|Secondary|Period of Progression-Free Survival|The median months without event of progression disease according to RECIST criteria is analysed.|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)||||months||95% Confidence Interval|Median
1236741|NCT00608868|Primary|Objective Response Rate(ORR)|"Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated.~According RECIST criteria, CR(complete response) - the disappearance of all target lesions and ‘PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter."|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)||||Percent of participants|||Number
1236742|NCT00608842|Primary|Number of Participants With Positive Histopathology Results at Week 20|After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.|Week 20|Safety population with biopsy results at week 20|||participants|||Number
1236743|NCT00608842|Primary|Number of Participants With Positive Histopathology Results at Screening|A needle core tissue sample biopsy was performed at screening for all treated lipomas.|Screening (prior to randomization)|Safety population with biopsy results at screening|||participants|||Number
1236744|NCT00608842|Primary|Number of Participants With Clinically Significant Changes in Vital Signs or Weight||Up to 24 weeks|Safety population|||participants|||Number
1236745|NCT00608842|Secondary|Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas|Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area * 100. A positive change indicates a reduction in size.|Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)|MITT Population|||percent change||Standard Deviation|Mean
1236746|NCT00608842|Primary|Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities|An abnormality is defined as a value outside the limits of the expanded normal range/notable range.|24 weeks|Safety population|||participants|||Number
1236747|NCT00608842|Secondary|Percentage of Participants With Complete Clearance or ≥ 75% Clearance|"At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers.~Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s).~For participants with > 1 target lipoma, the total area of all target lipomas was used in the calculation of response."|Baseline and week 20 (8 weeks after last dose)|MITT Population|||percentage of participants|||Number
1236763|NCT00608543|Primary|Spatial Working Memory (SWM) Strategy Score|The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention|||units on a scale||Standard Deviation|Mean
1236808|NCT00608491|Secondary|Change in Blood Uric Acid||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1236748|NCT00608842|Primary|Number of Participants With Adverse Events (AEs)|"Severity of AEs was determined using the following scale:~Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: “Was there a reasonable possibility that the event may have been caused by treatment with study material?” A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator’s or sponsor’s opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard."|Up to 24 weeks|Safety population (all participants who received at least 1 dose of study medication)|||participants|||Number
1236749|NCT00608829|Primary|Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment|Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).|one year||||Participants|||Number
1236750|NCT00608777|Primary|The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2||week 2|||||||
1236751|NCT00608634|Secondary|Skin Related Events From Perillyl Alcohol at Administered Doses by Participants|The events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. (NCI)|3 months||||participants|||Number
1236752|NCT00608634|Primary|Change in Histopathology Score of Sun Damaged Skin by Treatment Group|The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 & 2), 2- inflammation (grades 0, 1 & 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were >3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of >3 cells into epidermis, 7- loss of granular layer. All assessments were done using a 40:1 objective.|Baseline to 3 months|change in histopathological scoring was calculated only for participants with baseline and end of study measurements. (n=79)|||units on a scale||Standard Deviation|Mean
1236753|NCT00608582|Primary|Phrase Length|Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description|Baseline and 2 months after the last rTMS treatment session|Chronic Stroke Patients with Aphasia who received either Real rTMS or Sham rTMS|||number of words per phrase length||Standard Deviation|Mean
1236754|NCT00608582|Primary|Picture Naming|Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures|Baseline and 2 months after the last rTMS treatment session|Chronic Stroke Patients with Aphasia who receive either a Real rTMS series or a Sham rTMS series|||number of pictures||Standard Deviation|Mean
1236755|NCT00608569|Secondary|Adherence to Second Line HAART Regimen|Number of participants with self-reported 100% adherence over the week prior to study visit|At weeks 4, 8, 12, 24, 36, 48 and 52|Only the 257 eligible participants were included in the analysis. Self-reported adherence was collected face-to-face or by self-report on the Adherence/Quality of Life/Psychosocial Interview form. Only adherence to LPV/rtv was collected.|||participants|||Number
1236756|NCT00608569|Secondary|Time to First Grade 3 or 4 Lab or Sign/Symptom Event|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.|||weeks||95% Confidence Interval|Number
1236757|NCT00608569|Secondary|Time to First Grade 3 or 4 Sign or Symptom|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.|||weeks||95% Confidence Interval|Number
1236758|NCT00608569|Secondary|Time to First Grade 3 or 4 Lab Event|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.|||weeks||95% Confidence Interval|Number
1236759|NCT00608569|Secondary|CD8 Count at Follow-up Visits|CD8 cell count (median, inter-quartile range)|At week 4, 12, 24, 36, and 48||||cells/mm3||Inter-Quartile Range|Median
1236760|NCT00608569|Secondary|CD4 Count at Follow-up Visits|CD4 cell count (median, inter-quartile range)|At Weeks 4, 12, 24, 36, and 48||||cells/mm3||Inter-Quartile Range|Median
1236761|NCT00608569|Secondary|Confirmed Virologic Failure at or Prior to Week 24|Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported.|At or prior to Week 24|Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.|||participants|||Number
1236762|NCT00608569|Primary|Confirmed Virologic Failure at or Prior to Week 48|Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported.|At or prior to Week 48|Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.|||participants|||Number
1236809|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1236764|NCT00608543|Primary|Spatial Working Memory (SWM) Between Errors for 6-move Problems|The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers because data were collected pre- and post-treatment|||number of errors||Standard Deviation|Mean
1236765|NCT00608543|Primary|Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems|The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention|||milliseconds||Standard Deviation|Mean
1236766|NCT00608543|Secondary|Change in Hamilton Rating Scale for Depression (HRSD - 17-item)|The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.|6 weeks|Study completers who completed the HRSD pre- and post-intervention; mean represents mean difference from pre- to post-intervention|||units on a scale||Standard Deviation|Mean
1236767|NCT00608543|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire|The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.|6 weeks|Study completers who completed the Q-LES-Q pre- and post-intervention; mean represents mean difference from pre- to post-intervention|||units on a scale||Standard Deviation|Mean
1236768|NCT00608543|Primary|Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems|The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention|||milliseconds||Standard Deviation|Mean
1236769|NCT00608530|Secondary|Percentage of Participants Rating Global Impression of Change as 'Much Improved' or 'Very Much Improved'|Participant self-rating of overall change compared to baseline, considering overall function and pain intensity, using a 7-point scale ranging from 'Very Much Worse' to 'Very Much Improved.' We compared the proportion of participants in each Group rating themselves as either 'Much Improved' or 'Very Much Improved.'|End of Treatment (8 weeks)|Modified intent-to-treat analysis of all participants who attended at least 1 treatment session|||percentage of participants|||Number
1236770|NCT00608530|Secondary|Patient-rated Global Clinical Impression of Percent Change in Overall Pain and Function|"Participant rating of overall improvement compared to baseline in terms of back pain impact on everyday function, self-categorized as Better, Worse, or About the Same. Participants then were asked to estimate the percentage of change (i.e., 0 to 100%). Participants rating themselves as About the Same were coded as 0% change. The percentage of change was calculated for each Group as a whole (Cognitive Behavioral Therapy-Psychologist Delivered compared to Supportive Care Psychologist-Delivered)."|End of Treatment (8 weeks)|Intent-to-treat analysis of all randomized participants; multiple imputation was used to address missing data.|||percent change||Standard Deviation|Mean
1236771|NCT00608530|Secondary|Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Nurse-Delivered Treatment Study|"The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from 0 to 1 0 where 0 indicates no pain and 10 indicates the worst imaginable pain."|Baseline, End of Treatment of Nurse-Delivered Treatment Study (8 weeks)|Modified intent-to-treat analysis of all randomized participants who attended 1 or more treatment visits; multiple imputation used to address missing data.|||units on a scale||Standard Deviation|Mean
1236772|NCT00608530|Secondary|Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Psychologist-Delivered Treatment Study|"The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from 0 to 1 0 where 0 indicates no pain and 10 indicates the worst imaginable pain."|Baseline, End of Treatment (8 weeks)|Intent-to-treat analysis of all randomized participants, using multiple imputation to address missing data.|||units on a scale||Standard Deviation|Mean
1236773|NCT00608530|Primary|Roland and Morris Disability Questionnaire Nurse-Delivered Treatment Study|"The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase because of my back pain (e.g., Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability."|Baseline, End of Treatment for Nurse-Delivered Treatment Study (8 weeks)|All randomized participants who attended at least 1 treatment session were analyzed, with multiple imputation used to address missing data.|||units on a scale||Standard Deviation|Mean
1236774|NCT00608530|Primary|Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study|"The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase because of my back pain (e.g., Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability."|Baseline, End of Treatment (8 weeks)|Per protocol population. All participants with baseline and Week 8 disability scores.|||units on a scale||Standard Deviation|Mean
1236780|NCT00608517|Secondary|Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells|Recovery of the neutrophil portion of white blood cells and showing complete donor cells.|42 days|Patients who received treatment and who did not die before day 42.|||participants|||Number
1236781|NCT00608517|Primary|Number of Participants With 100-day Non-relapse Mortality|Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).|100 days||||participants|||Number
1236782|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1236783|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1236784|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1236785|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1236786|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1236787|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1236788|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL/hr||Standard Deviation|Mean
1236789|NCT00608491|Secondary|Change in Blood N Terminal Pro - B Natriuretic Peptides||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1236790|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1236791|NCT00608491|Secondary|Change in Blood Uric Acid||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1236792|NCT00608491|Secondary|Best Available Glomerular Filtration Rate Change|Core laboratory when available. If not available, local laboratory results were used.|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min||Standard Deviation|Mean
1236793|NCT00608491|Secondary|Best Available Serum Creatinine Change|Core laboratory when available. If not available, local laboratory results were used.|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1236794|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
1236795|NCT00608491|Secondary|Weight Change||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
1236796|NCT00608491|Secondary|Glomerular Filtration Rate Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min||Standard Deviation|Mean
1236797|NCT00608491|Secondary|Creatinine Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1236798|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
1236799|NCT00608491|Secondary|Weight Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
1236800|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1236801|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1236802|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1236803|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1236804|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1236805|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1236806|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL/hr||Standard Deviation|Mean
1236807|NCT00608491|Secondary|Change in Blood N Terminal Pro-Natriuretic Peptide||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1236830|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
1236831|NCT00608491|Secondary|Change in Global Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled “best you have ever felt” and the bottom labeled “worst you have ever felt”."|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1236832|NCT00608491|Secondary|Change in Dyspnea Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better"|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1236833|NCT00608491|Secondary|Change in Global Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled “best you have ever felt” and the bottom labeled “worst you have ever felt”."|Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1236834|NCT00608491|Secondary|Dyspnea Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better"|Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1236835|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1236836|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 6|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1236837|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 5|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1236838|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1236839|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 3|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1236840|NCT00608491|Primary|Change in Weight||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
1236841|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 2|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1236842|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 1|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1236843|NCT00608491|Secondary|Change in Weight||Change from Baseline to Day 6|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
1236844|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 5|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
1236845|NCT00608491|Secondary|Change in Weight||Change from Baseline to Day 3|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
1236846|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 2|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
1236847|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 1|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
1236848|NCT00608491|Secondary|Change in Glomerular Filtration Rate||Change from Baseline to Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min||Standard Deviation|Mean
1236849|NCT00608491|Secondary|Change in Serum Creatinine||Change from Baseline to Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1236850|NCT00608491|Secondary|Change in Glomerular Filtration Rate||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min||Standard Deviation|Mean
1236851|NCT00608491|Primary|Change in Serum Creatinine||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1236852|NCT00608465|Primary|This Study Will Analyze Patients' Genetic Make up to Identify Who May be at Greater Risk for Heart Disease and Strokes in Relationship to High Blood Pressure and Central Obesity.||10-weeks|Enrollment was never completed so study was never unblinded and data was never analyzed||||||
1236853|NCT00608465|Primary|Secreted Factors From Adipocytes Have Autocrine, Paracrine and Endocrine Effects That Have a Deleterious Effect on the Fibrinolytic System, Either by Enhancing PAI-1 Production or Impairing Endothelial t-PA Release||10-Week period|Enrollment was never completed so study was never unblinded and data was never analyzed||||||
1236854|NCT00608426|Secondary|7-day Point Prevalence Abstinence||12 months after randomizatoin|Out of the 3382 completed follow-up surveys, 3056 completed the 7-day point prevalence outcome.|||percentage of participants|||Number
1236855|NCT00608426|Secondary|Treatment Utilization Rates for Counseling and/or Pharmacotherapy||12 months after randomization||||percentage of participants|||Number
1236856|NCT00608426|Primary|Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence||12 months after randomization|Out of the 3382 completed follow-up surveys, 3307 completed the primary smoking-abstinence outcome.|||percentage of participants|||Number
1236857|NCT00608322|Secondary|Lactate Clearance (Blood)||0-2 hours of study drug administration|||||||
1236858|NCT00608322|Primary|Change in Sublingual Microcirculatory Flow Index (MFI)|The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.|0-2 hours of study drug administration||||units on a scale||Inter-Quartile Range|Median
1236859|NCT00608322|Primary|Change in the Sequential Organ Failure Assessment (SOFA) Score||0-24 hours from protocol initiation|||||||
1236860|NCT00608244|Primary|Safety Evaluation|A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.|52 days|All enrolled patients are included in the safety population.|||participants|||Number
1236861|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24) on Day 21.|"Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).~The following time points were used to obtain the PK curve for LCP-Tacro on day 21: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20 and 24 hours post-dose."|21 Days|"57 completed the study but one patient was excluded from the PP analysis due to low trough levels.~The arithmetic mean and standard deviation is given."|||ng*hr/mL||Standard Deviation|Mean
1236862|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.|21 Days|"57 completed the study but one patient was excluded from the PP analysis due to low trough levels.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
1236863|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|"Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.~The following time points were used to obtain the PK curve for Prograf on day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 15, 16, 20 and 24 hours after the morning dose."|7 Days|The arithmetic mean and standard deviation is given.|||ng*hr/mL||Standard Deviation|Mean
1236864|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Trough Levels (C24).|Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.|7 Days|The arithmetic mean and standard deviation is given.|||ng/mL||Standard Deviation|Mean
1236865|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236866|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236867|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236868|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236869|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236870|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236871|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236872|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236873|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236874|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236875|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236876|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236877|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236878|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236879|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236880|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236881|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236882|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236883|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236884|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236885|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236886|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236887|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236888|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236889|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236890|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236891|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236892|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236893|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236894|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236895|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236896|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).~N (number of patients analyzed) is based on number of patients who completed the question."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1236897|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||participants|||Number
1236898|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||participants|||Number
1236899|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||participants|||Number
1236900|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||participants|||Number
1236901|NCT00608205|Secondary|Disease Recurrence|Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.|2 years after start of study|Patients that had a complete response after 12 weeks of therapy|||participants|||Number
1236902|NCT00608205|Secondary|Number of Patients With a Pathological(Final)Complete Response|A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.|at 12 weeks after completing chemoradiotherapy and surgery||||participants|||Number
1236903|NCT00608205|Secondary|Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor|Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.|at 12 weeks after completing chemoradiotherapy|intention to treat (ITT)|||participants|||Number
1236904|NCT00608205|Secondary|Overall Survival|Number of patients still alive from 2 years from start of study|2 yrs from start of study|intention to treat (ITT)|||participants|||Number
1236905|NCT00608205|Secondary|Patterns of Failure|Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.|2 years from start of study|intention to treat (ITT)|||participants|||Number
1236906|NCT00608205|Primary|Relapse Free Survival|Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..|at 2 yrs from start of study|intention to treat (ITT)|||participants|||Number
1236907|NCT00608140|Secondary|Perioperative Mortality||Measured between Days 0 and 30 postsurgery||||participants|||Number
1236974|NCT00607815|Secondary|State-Trait Anxiety Scale|Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73.|post-treatment, at 3 months and 1 year||||units on a scale||Standard Deviation|Mean
1236908|NCT00608140|Secondary|Total Mortality (All Causes)|Total all-cause mortality at 18 months. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.|Measured at Month 18|The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.||||||
1236909|NCT00608140|Secondary|Total Days Alive and Total Days Not Hospitalized|Total days alive and not hospitalized by 18 months. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.|Measured at baseline and Month 18|The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.||||||
1236910|NCT00608140|Secondary|Change in Minnesota Living With Heart Failure (MLHF) Score|Change in MLHF score. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.|Planned to be measured at baseline and Month 18 but n/a|the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.||||||
1236911|NCT00608140|Secondary|Change in 6-minute Walk Test|The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.|Measured at baseline and Month 18 but n/a|The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.||||||
1236912|NCT00608140|Secondary|Peak VO2||Measured at Month 18|The 2 patients enrolled in the study did not reach their endpoints before the trial was closed. No data were collected for this outcome measure and no analysis was performed.||||||
1236913|NCT00608140|Primary|Effect of Adding SMVR to OMT Alone on LV Remodeling, Specifically LV End-systolic Volume Index (LVESVI)||Measured at Month 18|Data were not analyzed due to study termination||||||
1236914|NCT00608023|Primary|Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52|Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.|Baseline and Week 52||||mg/dL||Standard Deviation|Mean
1236915|NCT00608023|Primary|Changes From Baseline in Fasting Blood Glucose at Week 52|Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.|Baseline and Week 52||||mg/dL||Standard Deviation|Mean
1236916|NCT00608023|Other Pre-specified|Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52|Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported.|Baseline and Week 52||||ratio||Standard Deviation|Mean
1236917|NCT00608023|Other Pre-specified|Changes From Baseline in Triglycerides at Week 52|Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.|Baseline and Week 52||||mg/dL||Standard Deviation|Mean
1236918|NCT00608023|Secondary|Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52|Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.|Baseline and Week 52|All data were included in the analysis by intention to treat principles. Intent to treat populations were defined as all randomized subjects who were exposed to study drug (i.e injection of at least 1 dose of study drug).|||cm^2||Standard Deviation|Mean
1236919|NCT00607997|Secondary|Pharmacokinetics Day 4 - Vss (L)|"Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data for Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.|||L||Standard Deviation|Mean
1236920|NCT00607997|Secondary|Pharmacokinetics Day 4 - CL (L/hr)|"Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.|||L/hr||Standard Deviation|Mean
1236921|NCT00607997|Secondary|Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)|"Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data, for 5 patients in Schedule C, and for 7 patients in Schedule C.|||hr||Standard Deviation|Mean
1236922|NCT00607997|Secondary|Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)|"Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 8 patients in Schedule C.|||hr*ng/mL||Standard Deviation|Mean
1236923|NCT00607997|Secondary|Pharmacokinetics Day 1 - Vss (L)|"Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||L||Standard Deviation|Mean
1236924|NCT00607997|Secondary|Pharmacokinetics Day 1 - CL (L/hr)|"Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||L/hr||Standard Deviation|Mean
1236925|NCT00607997|Secondary|Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)|"Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||hr||Standard Deviation|Mean
1236926|NCT00607997|Secondary|Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)|"Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||hr*ng/mL||Standard Deviation|Mean
1236927|NCT00607997|Secondary|All Cause Mortality|Mortality of those patients enrolled in the study and receiving intervention|30 and 60 days|All treated analysis set|||Participants|||Count of Participants
1236928|NCT00607997|Secondary|Pharmacokinetics Day 4 Cmax (ng/mL)|"Pharmacokinetic Parameters by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) on Day 4~Please note that N, mean and CV% are reported, but CV% is not an option in the drop down menu. So Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4 for 5 patients in Schedule C, and for 8 patients in Schedule C .|||ng/mL||Standard Deviation|Mean
1236929|NCT00607997|Secondary|Pharmacokinetics Day 1 - Cmax (ng/mL)|"Pharmacokinetic Parameters (Cmax) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||ng/mL||Standard Deviation|Mean
1236930|NCT00607997|Secondary|Overall Survival||2 years|All treated patients|||Months||95% Confidence Interval|Median
1236931|NCT00607997|Secondary|Leukemia-free Survival (LFS)|The censor date was the last known alive date without report of relapse.|2 years|All treated analysis set|||Months||95% Confidence Interval|Median
1236932|NCT00607997|Primary|Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions|"Combined remission rate (complete remission [CR] + complete remission with incomplete platelet recovery [CRp]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set.~Per IWG criteria, a CR requires bone marrow blasts < 5%, absolute neutrophil count (ANC) > 1000 cells/uL, and platelet (plt) count > 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count <= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse."|2 years|The all treated analysis set Included all enrolled patients who received any amount of vosaroxin.|||percentage of patients||95% Confidence Interval|Number
1236933|NCT00607919|Secondary|Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint|The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236934|NCT00607919|Secondary|Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint|The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236935|NCT00607919|Secondary|Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint|LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236936|NCT00607919|Secondary|Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236937|NCT00607919|Secondary|Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236938|NCT00607919|Secondary|Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236939|NCT00607919|Secondary|Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236940|NCT00607919|Secondary|Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint|The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236941|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint|The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units||Standard Deviation|Mean
1236942|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint|The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236943|NCT00607919|Secondary|Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint|The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236975|NCT00607815|Secondary|State-Trait Anger Scale (STAXI)|Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37.|post-treatment, at 3 months and 1 year||||units on a scale||Standard Deviation|Mean
1236944|NCT00607919|Secondary|Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint|The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236945|NCT00607919|Secondary|Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint|LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236946|NCT00607919|Secondary|Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236947|NCT00607919|Secondary|Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint|The TOWRE is a measure of an individual’s ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236948|NCT00607919|Secondary|Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32–Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236949|NCT00607919|Secondary|Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236950|NCT00607919|Secondary|Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint|The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236951|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint|The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236952|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1236976|NCT00607815|Secondary|Beck Depression Inventory - II (BDI-II)|Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed.|post-treatment, at 3 months and 1 year||||units on a scale||Standard Deviation|Mean
1236953|NCT00607919|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1236954|NCT00607893|Secondary|Augmentation Index, Morning|Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment||||percent change||95% Confidence Interval|Least Squares Mean
1236955|NCT00607893|Secondary|Augmentation Index, Evening|Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment||||percent change||95% Confidence Interval|Least Squares Mean
1236956|NCT00607893|Secondary|Pulse Wave Velocity, Morning|Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment||||cm/s||95% Confidence Interval|Least Squares Mean
1236957|NCT00607893|Secondary|sIL-6R|Measures of inflammation outcome, logarithm transformed before analysis due to skewed distribution, analyzed change of from baseline with adjustment of baseline. The least squares mean is transformed back to present the percent change from baseline.|Measured between baseline and after treatment||||percent change||95% Confidence Interval|Least Squares Mean
1236958|NCT00607893|Secondary|Mean Arterial BP, Morning|Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||mm Hg||95% Confidence Interval|Least Squares Mean
1236959|NCT00607893|Secondary|IL-6|Measures of inflammation outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||pg/mL||95% Confidence Interval|Least Squares Mean
1236960|NCT00607893|Secondary|Pulse Wave Velocity, Evening|Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||cm/s||95% Confidence Interval|Least Squares Mean
1236961|NCT00607893|Secondary|Mean Arterial BP, Evening|Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||mm Hg||95% Confidence Interval|Least Squares Mean
1236962|NCT00607893|Primary|Myeloperoxidase|Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||pmol/L||95% Confidence Interval|Least Squares Mean
1236963|NCT00607893|Primary|F2-isoprostanes/Cr|Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||ng/mg||95% Confidence Interval|Least Squares Mean
1236964|NCT00607880|Secondary|Termination of Use of the Indwelling Port at 12 Months After Port Insertion|The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.|Up to 12 months after port insertion||||participants|||Number
1236965|NCT00607880|Secondary|Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion|We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.|Up to 12 months after port insertion|All patients accrued to this study that had their port removed within12 months for any reason other than infection/occlusion were included in this analysis. 28 patients using the Standard Access Port and 30 patients using the Vortex Implantable Access Port had port removal prior to 12 months due to reasons other than infection or occlusion..|||participants|||Number
1236966|NCT00607880|Secondary|Death From All Causes|Number of patients that died during treatment due to any cause.|Up to 12 months after port insertion||||participants|||Number
1236967|NCT00607880|Primary|Port Failure Within 12 Months of Port Insertion|We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure.|Up to 12 months from port insertion|Patients with port failure within 12 months and patients that were followed 12 months without port failure were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
1236968|NCT00607867|Secondary|Change in Fasting Triglycerides at 5 Weeks From Baseline|Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention|baseline and 5 weeks after dietary intervention||||mg/dl||Standard Error|Mean
1236969|NCT00607867|Primary|Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline|Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.|baseline and 5 weeks after dietary intervention||||mg/dl||Standard Error|Mean
1236970|NCT00607867|Primary|Change in Body Weight at 5 Weeks From Baseline|Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.|baseline and 5 weeks after dietary intervention||||pounds||Standard Error|Mean
1236971|NCT00607867|Primary|Change in Total Glucose Area at 5 Weeks From Baseline|The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.|Baseline and 5 weeks after dietary intervention||||mg hr/dl||Standard Error|Mean
1236972|NCT00607867|Secondary|Microalbumin Excretion|change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention|baseline and 5 weeks after dietary intervention||||mg/day||Standard Error|Mean
1236977|NCT00607815|Primary|PTSD Checklist (PCL)|17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed|post-treatment, at 3 months and 1 year||||units on a scale||Standard Deviation|Mean
1236978|NCT00607815|Primary|Clinician Administered PTSD Scale|Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed.|Post-treatment, at 3 months and 1 year|Generalized estimating equations (GEE) were used to test study hypotheses.|||units on a scale||Standard Deviation|Mean
1236979|NCT00607789|Secondary|Weekly Episodes|The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)|12 weeks|The secondary efficacy analysis was a longitudinal analysis comparing the rate of change of binge weeks frequency during the treatment period between groups.|||Days||Standard Deviation|Mean
1236980|NCT00607789|Primary|Binge Eating Days|The mean number of binge days (days when the participant had one or more binge eating episodes) per week in the interval between visits (total number of binge days in the interval divided by number of days in the interval, then multiplied by 7).|12 weeks|The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups.|||Mean Number of days||Standard Deviation|Mean
1236981|NCT00607724|Secondary|PFS: Participants With BCC|PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants with BCC were included in the analysis. Number of participants censored for Stage 1+Stage 2 150 mg, and Stage 1+Stage 2 270 mg were 8 and 7 subjects, respectively, and no subject censored from Stage 1 540 mg group.|||months||95% Confidence Interval|Median
1236982|NCT00607724|Secondary|Progression-Free Survival (PFS): All Participants|PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population. Number of participants censored for Stage 1 150 mg, 270 mg, and 540 mg were 1, 2, and 1 subjects, respectively and for Stage 2 BCC 150 mg, 270 mg, Stage 2 Safety Expansion Cohort 150 mg, and Stage 2 New Formulation 150 mg were 2, 6, 1, and 6 subjects, respectively.|||months||95% Confidence Interval|Median
1236983|NCT00607724|Secondary|Duration of Objective Response: Participants With BCC|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable participants; only participants with BCC who achieved a best overall response of CR or PR were included in the analysis.|||months||Full Range|Median
1236984|NCT00607724|Secondary|Duration of Objective Response: All Participants|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants who achieved a best overall response of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
1236985|NCT00607724|Secondary|Percentage of Participants With a BOR of CR or PR: Participants With Basal Cell Carcinoma|BOR was defined as the best objective response observed during the treatment period according to RECIST v1.0. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants with BCC were included in the analysis.|||percentage of participants|||Number
1236986|NCT00607724|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): All Participants|BOR was defined as the best objective response (complete or partial response determined by two consecutive investigator assessments which were at least 28 days apart) observed during the treatment period according to RECIST v1.0. CR: disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population were those with measurable disease at baseline and who received at least 1 dose of GDC-0449 and either had a post-baseline tumor assessment or progressed before any tumor assessment.|||percentage of participants|||Number
1236987|NCT00607724|Secondary|Percentage of Participants With a Greater Than (>) 2-Fold Down-Modulation of GLI1 Expression in Skin Biopsy-Derived or Hair Follicle-Derived Messenger Ribonucleic Acid (mRNA)|Ribonucleic acid (RNA) was extracted from biopsy specimens of noninvolved skin or hair follicles at baseline and at 7 and 21 days after the start of daily drug therapy. Control mRNA was obtained from formalin-fixed, paraffin-embedded samples of normal skin and hair follicles from participants who were not enrolled in the study.|Baseline up to Day 29|"Pharmacodynamic-evaluable population included participants who had hair and/or skin samples available from Day 1 and at least one post-baseline sample while on study treatment. Here number of participants analyzed = participants evaluable for this measure and n= participants evaluable for the specific category."|||percentage of participants|||Number
1237001|NCT00607672|Secondary|Stroke|New onset neurological deficit with a duration of longer than 24 hours|From arrival in intensive care unit until discharge from hospital||||percentage of patients|||Number
1236988|NCT00607724|Primary|Accumulation Index (AI) After Multiple Doses of GDC-0449|AI was calculated using the formula [AI = AUC(0-24) on Day 15/AUC(0-24) on Day 1]. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AI was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|AI was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AI.||||||
1236989|NCT00607724|Primary|AUC0-24 After Multiple Doses of GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|AUC0-24 was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AUC0-24.||||||
1236990|NCT00607724|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) After a Single Dose of GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|PK-evaluable population.|||mcM*day||Standard Deviation|Mean
1236991|NCT00607724|Primary|Average Plasma Concentration at Steady State (Css, Avg) After Multiple Doses of GDC-0449|Steady state GDC−0449 plasma concentrations (Css) were calculated as an average of plasma concentrations from Study Day 21 (Stage 2) or Study Day 28 (Stage 1) onward.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|"PK-evaluable population. Here number of participants analyzed = participants evaluable for this measure."|||mcM||Standard Deviation|Mean
1236992|NCT00607724|Primary|Tmax After Multiple Doses of GDC-0449|Tmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|Cmax was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax, and as Tmax was related to Cmax, it was also not estimated.||||||
1236993|NCT00607724|Primary|Time to Maximum Plasma Concentration (Tmax) After a Single Dose of GDC-0449|Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|PK-evaluable population.|||days||Full Range|Median
1236994|NCT00607724|Primary|Cmax After Multiple Doses of GDC-0449|Cmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|Cmax was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax.||||||
1236995|NCT00607724|Primary|Maximum Observed Plasma Concentration (Cmax) After a Single Dose of GDC-0449|Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and pharmacodynamic (PD) data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|Pharmacokinetic (PK)-evaluable population included participants who had at least Day 1 PK samples available.|||micromolar (mcM)||Standard Deviation|Mean
1236996|NCT00607724|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs)|A DLT was defined as any Grade 3 or 4 hematologic or major organ toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) that occurred during the first 35 days after the initiation of study drug (Days 1−35) and was attributable to GDC-0449.|Up to Week 6|Safety-evaluable population.|||percentage of participants|||Number
1236997|NCT00607672|Primary|Interleukin-10 (IL-10) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by the IL-10 response|From the start of surgery until postoperative day 2||||pg/mL||Standard Error|Mean
1236998|NCT00607672|Primary|Interleukin-8 (IL-8) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-8|From the start of surgery until postoperative day 2||||pg/mL||Standard Error|Mean
1236999|NCT00607672|Primary|Interleukin-6 (IL-6) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-6|From the start of surgery until postoperative day 2||||pg/mL||Standard Error|Mean
1237000|NCT00607672|Secondary|Length of Hospital Stay||From the start of surgery until discharge from hospital||||days||Standard Error|Mean
1237002|NCT00607672|Secondary|Acute Kidney Injury|Acute kidney injury (AKI) was defined according to Acute Kidney Injury Network (AKIN) criteria,specifically any increase in subject serum creatinine concentration of 50% or 0.3 mg/dL (26.5 umol/L) within 72 hours of surgery.|From the start of surgery until postoperative day 3||||percentage of patients|||Number
1237003|NCT00607672|Secondary|New Onset Atrial Fibrillation|New onset atrial fibrillation based on electrocardiogram (ECG) rhythm strips with a duration longer than 10 seconds|From arrival in intensive care unit until discharge from hospital||||percentage of patients|||Number
1237004|NCT00607672|Secondary|Vasopressor Drug Use||From the end of cardiopulmonary bypass until arrival in intensive care unit||||percentage of patients|||Number
1237005|NCT00607672|Secondary|Blood Product Transfusion Requirement|Percentage of patients that received blood product transfusion|From the start of surgery until discharge from hospital||||percentage of patients|||Number
1237006|NCT00607672|Secondary|Re-exploration for Bleeding|The percentage of patients that were taken back to the operating room for re-exploration because of bleeding|From arrival in intensive care unit until discharge from hospital||||percentage of patients|||Number
1237007|NCT00607672|Secondary|Blood Loss|Blood loss over 24 hours as measured by chest tube output|First 24 hours after arrival in the intensive care unit||||mL||Standard Error|Mean
1237008|NCT00607672|Primary|Plasminogen Activator Inhibitor-1 (PAI-1) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the fibrinolytic responses to CPB as measured by PAI-1 response|From the start of surgery until postoperative day 2||||ng/mL||Standard Error|Mean
1237009|NCT00607672|Primary|Tissue-type Plasminogen Activator (t-PA) Antigen Response|To compare the effects of angiotensin II type I (AT1) receptor antagonism or angiotensin-converting enzyme (ACE) inhibition versus placebo on the fibrinolytic responses to cardiopulmonary bypass (CPB) as measured by t-PA antigen response|From the start of surgery until postoperative day 2||||ng/mL||Standard Error|Mean
1237010|NCT00607620|Secondary|Alcohol Use Problems|The investigators will use the Short Inventory of Problems (SIP) as a continuous measure. The 16-item scale score ranges from 0-48 with higher scores indicating worse outcomes.|The investigators will assess at 6-month and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||units on a scale||Standard Error|Mean
1237011|NCT00607620|Secondary|Number of Binge Drinking Days|The investigators will use the Form 90 to assess the number of days in which a male participants consumed ≥5 alcoholic drinks and female participants consumed ≥4 alcoholic drinks|The investigators will assess at 6-month and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||days||Standard Error|Mean
1237012|NCT00607620|Secondary|Number of Abstinent Days|The investigators will use the Form 90 to assess the number of days within the last 90 days in which a patient did not consume alcohol.|The investigators will assess at 6- and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||days||Standard Error|Mean
1237013|NCT00607620|Primary|Alcohol Use Problems|The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.|The investigators will assess at baseline, 6-month and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||units on a scale||Standard Deviation|Mean
1237014|NCT00607620|Primary|Number of Participants With Hazardous Drinking|The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a dichotomous measure. AUDIT Scores of ≥8 for men and ≥5 for women indicate hazardous drinking.|The investigators will assess at baseline, 6-month and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||Participants|||Count of Participants
1237015|NCT00607594|Secondary|Association Between Correlative Markers and Clinical Outcomes|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|At baseline, 6 months, and then at 1 year|data were not collected||||||
1237016|NCT00607594|Secondary|Patient Tolerability|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Weekly during treatment|Data were not collected||||||
1237017|NCT00607594|Secondary|Highest Grade Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.|Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.|Weekly during treatment||||highest grade|||Number
1237018|NCT00607594|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall and time to progression estimates. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year (median, 6 months, and 1 year)|Only 17 patients were evaluable for response|||months||95% Confidence Interval|Median
1237019|NCT00607594|Secondary|Median Survival|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year||||months||95% Confidence Interval|Median
1237020|NCT00607594|Secondary|Progression-free Survival|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Measured from the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy|Only 17 patients were evaluable for response|||months||95% Confidence Interval|Median
1237063|NCT00607269|Primary|Amount ($) Earned for Targeted Prosocial and Healthy Behaviors|Participants earned contingency management vouchers for targeted prosocial and healthy behaviors. 1 voucher = $1|24 Weeks||||$ Vouchers||Standard Deviation|Mean
1237021|NCT00607594|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions,or a measurable increase in non-target lesions, or the appearance of new lesions.|Up to 1 year (median, 6 month, 1-year)||||months||95% Confidence Interval|Median
1237022|NCT00607594|Primary|Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)||Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks||||participants|||Number
1237023|NCT00607594|Primary|Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)|PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.|Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks||||participants|||Number
1237024|NCT00607477|Primary|Magnitude of Change in Blood Pressure||21 days|No participants analyzed due to poor accrual and insufficient numbers of participants.||||||
1237025|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steadystate.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||milliliter per kilogram||Standard Deviation|Mean
1237026|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||milliliter/minute/kilogram||Standard Deviation|Mean
1237027|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Mean Residence Time From Time 0 to Infinity (MRTinf)|MRTinf is an average duration of the drug in the body from time zero to infinity, and is expressed in minutes.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||minutes||Standard Deviation|Mean
1237028|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Elimination Half-Life (t1/2)|t1/2 refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in minutes and derived from the terminal slope of the concentration versus time curve.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||minutes||Standard Deviation|Mean
1237029|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf)||Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||minute*nanogram per milliliter||Standard Deviation|Mean
1237030|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Area Under the Serum Concentration-Time Curve From Time 0 to the Final Time Point With a Concentration of at Least Lower Limit of Quantitation (AUClast)||Weeks 1 and 27|PK population. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.|||minute*nanogram per milliliter||Standard Deviation|Mean
1237031|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Time of Maximum Observed Serum Concentration (Tmax)||Weeks 1 and 27|PK population. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.|||minutes||Standard Deviation|Mean
1237032|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Maximum Observed Serum Concentration (Cmax)||Weeks 1 and 27|Pharmacokinetic (PK) population was defined as all enrolled participants who had at least one serum concentration measurement available. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.|||nanogram per milliliter||Standard Deviation|Mean
1237033|NCT00607386|Secondary|Mean Change From Baseline to Week 53 in Normalized Urinary Glycosaminoglycan (GAG) Levels|Analysis of urinary GAG levels was performed at baseline, Week 18, Week 36, and Week 53 as an assessment of the pharmacodynamic effects of Elaprase (idursulfase).|Baseline, Weeks 18, 36 and 53|Safety population. In the categories listed below, 'N' signifies the number of participants evaluable for the timepoint.|||microgram/milligram creatinine||Standard Deviation|Mean
1237034|NCT00607386|Primary|Safety Evaluation|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs occurred after start of study treatment until 30 days after the last infusion of idursulfase, were reported.|From the start of study treatment until 30 days after the last infusion of idursulfase, up to 53 weeks|Safety population was defined as all enrolled participants who received at least one study dose (or any portion of a dose) of idursulfase.|||participants|||Number
1237035|NCT00607373|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1237061|NCT00607269|Secondary|Self-reported Psychiatric Symptoms at 12-month Follow-up.|As measured by the General Severity Index (GSI), a summary domain included on the Brief Symptom Inventory. The GSI combines information on both the number of symptoms described and the severity of those symptoms. Lower values on the GSI indicate less severe symptoms. Normative non-patient populations have been shown to have average GSI scores with a mean of 0.30 and a standard deviation of 0.31. Normative outpatient psychiatric patients have demonstrated GSI scores with a mean of 1.32 with a standard deviation of 0.72.|12 months||||Units of General Severity Index||Standard Deviation|Mean
1237036|NCT00607373|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1237037|NCT00607373|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1237038|NCT00607373|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1237039|NCT00607373|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||ratio||Standard Deviation|Mean
1237040|NCT00607373|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1237041|NCT00607373|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1237042|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1237043|NCT00607373|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1237044|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1237045|NCT00607373|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1237046|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1237047|NCT00607373|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1237062|NCT00607269|Primary|Proportion of Level 1 (i.e., Drug Negative Urines and Alcohol Negative Breath) Clean Urine Samples Provided at 12-month Follow-up, by Condition.||24 Weeks||||Proportion of Lvl 1 Clean Urine Samples|||Number
1237048|NCT00607373|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1237049|NCT00607373|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1237050|NCT00607373|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1237051|NCT00607373|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1237052|NCT00607373|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28 )|Full analysis set|||mg/dL||Standard Deviation|Mean
1237053|NCT00607373|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1237054|NCT00607373|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. If the Study Day 1 and screening LDL-C values were >12% different (relative to the maximum value), then the screening value was not used, because the Study Day 1 value represents the best estimate of the patient's condition at the beginning of study drug administration. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.|||percentage of baseline||Standard Deviation|Mean
1237055|NCT00607321|Secondary|Number of Participant With Target Vessel Failure at 12 Months|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|12 month|Includes all subjects receiving bifurcation stents and having evaluable data.|||participants|||Number
1237056|NCT00607321|Secondary|Number of Participants With Target Vessel Failure at 9 Months.|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|9 month|Includes all subjects receiving bifurcation stents and having evaluable data|||participants|||Number
1237057|NCT00607321|Secondary|Number of Participants With Target Vessel Failure (TVF) at 6 Months|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|6 month|Includes all patients receiving bifurcation stent and having evaluable data.|||participants|||Number
1237058|NCT00607321|Secondary|Device Success|Device success is reported as Historical-standard definition: attainment of <50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan.|During index procedure|ITT included all subjects after a run-in subject at each site.|||participants|||Number
1237059|NCT00607321|Primary|Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|30 days||||Participants|||Number
1237060|NCT00607269|Secondary|Self-reported Sexual Behaviors at 12-month Follow-up|Count of recent (past 30 days) male sexual partners.|12 months||||Sexual Partners||Standard Deviation|Mean
1237064|NCT00607243|Secondary|Cell-mediate Immunity||14 or 28 days|||||||
1237067|NCT00607243|Primary|Cutaneous Take Reaction|The “take reaction”was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6–8. The vaccination site was photographed, and measures were taken.|7-9 day||||participants|||Number
1237068|NCT00607126|Secondary|PASAT|Cognitive measure of attention and information processing speed. Score goes from 0-60 with higher number indicating better performance. Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance|baseline, mid, completion, 3 months post training||||units on a scale||Standard Error|Mean
1237069|NCT00607126|Secondary|Fatigue|fatigue assessed by modified fatigue impact scale. This is a 21 item questionnaire which has a range from 0-84. Higher scores indicate more impact of fatigue on physical and cognitive functioning.|baseline, mid, completetion, 3 months post||||units on a scale||Standard Deviation|Mean
1237070|NCT00607126|Secondary|Distance|distance assessed by 6 minute walk test|baseline, mid point, end and 12 weeks after training||||feet||Standard Deviation|Mean
1237071|NCT00607126|Primary|Walking Speed as Assessed by 25' Timed Walk|This is the time needed for participant to walk 25 feet. Participant walks on a level surface. the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.|at beginning,mid point, end and 12 weeks after intervention||||seconds||Standard Deviation|Mean
1237072|NCT00607113|Primary|Net Change Relative to Baseline in Tumor Blood Flow|Tumor blood flow (ml/min/100gm) determined by functional computed tomography (CT). Functional computed tomography (CT) at baseline, after first and third cycles (21 day cycles). Change (percentage) calculated as tumor blood flow measured at baseline compared to tumor blood flow measurement taken at end of Cycle 1, week 3 (21 days), and again at end of Cycle 3, Week 9 (63 days).|Baseline to end of Cycle 3 (63 days)||||ml/min/100gm||Standard Deviation|Mean
1237073|NCT00607087|Secondary|Total Daily Bolus Insulin Dose|dose of every increment administered for example before meals|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||Units||Standard Deviation|Mean
1237074|NCT00607087|Secondary|Total Daily Basal Insulin Infusion|dose of the basal insulin regimen administered throughout the 24-hour period|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||Units||Standard Deviation|Mean
1237075|NCT00607087|Secondary|Glycosylated Hemoglobin: HbA1c|Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage||Standard Deviation|Mean
1237076|NCT00607087|Secondary|Time Interval Between Infusion Set Changes in Routine|"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).~Changes in routine correspond to interval between changes according to patient use."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||hours||Standard Deviation|Mean
1237077|NCT00607087|Secondary|Time Interval Between Infusion Set Changes: All Changes|"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).~All changes include all the changes whatever the reason such as routine or requested by occurrence of events."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||hours||Standard Deviation|Mean
1237078|NCT00607087|Secondary|Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site|"Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment.~Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment.~Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection.~Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||patients|||Number
1237079|NCT00607087|Secondary|Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year|Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events in patient-year||Standard Error|Mean
1237080|NCT00607087|Secondary|Rate of Severe Symptomatic Hypoglycemia Per Patient-year|"Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following:~the event was associated with a measured blood glucose level below 36 mg/dL~or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events in patient-year||Standard Error|Mean
1237081|NCT00607087|Secondary|Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year|Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events in patient-year||Standard Error|Mean
1237082|NCT00607087|Secondary|Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis|"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).~Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l"|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events per patient per month||Standard Error|Mean
1237083|NCT00607087|Secondary|Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis|"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).~Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l"|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage of patients||95% Confidence Interval|Number
1237084|NCT00607087|Secondary|Monthly Rate of Confirmed Infusion Set Occlusion||over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events per patient per month||Standard Error|Mean
1237085|NCT00607087|Secondary|Percentage of Patients With at Least One Confirmed Infusion Set Occlusion|"Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage of patients||95% Confidence Interval|Number
1237086|NCT00607087|Secondary|Monthly Rate of Unexplained Hyperglycemia||over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events per patient per month||Standard Error|Mean
1237087|NCT00607087|Secondary|Percentage of Patients With at Least One Unexplained Hyperglycemia|Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage of patients||95% Confidence Interval|Number
1237088|NCT00607087|Secondary|Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion|"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.~Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events per patient per month||Standard Error|Mean
1237089|NCT00607087|Primary|Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion|"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.~Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage of patients||95% Confidence Interval|Number
1237560|NCT00603538|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.|The screening assay for anti-CP-751,871 antibodies was performed.|Day 1 of Cycles 1 (predose) and 4, and end of study|All participants were screened for the ADA.|||participants|||Number
1237090|NCT00607048|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose up to a maximum of 8 cycles (6 months)|Data was not summarized as Human antihuman responses to CP-870893 were all below the limit of quantitation (endpoint titer of 4.32).||||||
1237091|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax|Assess activity of B cells in presence of CP-870893. HLA-DR is a component of the Major Histocompatibility Complex in humans and presents antigens for recognition by the immune system. Agents that engage CD40 have been reported to increase HLA-DR expression; increased HLA-DR expression may serve as a marker for CD40 binding by CP-870893. Positive values may indicate greater presence of cells associated with potential for antibody production. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
1237092|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax|Assess activity of B cells in presence of CP-870893. CD86 is a protein expressed on antigen-presenting cells and provides co-stimulatory signals for T cell (role in cell-modulated immunity) activation. Agents that engage CD40 have been reported to increase CD86 expression; increased CD86 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
1237093|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax|Assess activity of B cells in presence of CP-870893. CD54 is an intercellular adhesion molecule. When activated, leukocytes bind to endothelial cells via CD54 and then transmigrate into tissues. Agents that engage CD40 have been reported to increase CD54 expression; increased CD54 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
1237094|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax|Assess activity of B cells in the presence of CP-870893. CD23 is a low-affinity receptor that has a role in transportation in antibody feedback regulation. Agents that engage CD40 have been reported to increase CD23 expression; increased CD23 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate a potential for increased antibody response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
1237095|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax|Assess activity of B cells in the presence of CP-870893. CD40 is a costimulatory protein and is a target for CP-870893. Measurement of CD40 on white blood cells provides a measure of target modulation by CP-870893. Higher numbers may indicate potential for increased activation of antigen presenting cells. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
1237096|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax)|Assess activity of B cells (involved in production of antibodies) in presence of CP-870893. Clusters of differentiation (CD) are specific types of proteins on cell surface. CD19 is a B cell antigen receptor and is used to quantitate changes in proportion of B cells in peripheral blood as a consequence of therapy. Higher numbers may indicate a greater presence of CD19 on cell surface with increased potential for antigen response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set: All enrolled participants who started treatment and who had baseline and sufficient on-study samples to provide interpretable results. N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
1237097|NCT00607048|Secondary|Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX|Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose|Pharmacokinetic data analysis set. CYTO0 values = the lower limit of quantitation (LLOQ).|||pg/mL||Standard Deviation|Mean
1237098|NCT00607048|Secondary|Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX)|Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose|Pharmacokinetic data analysis set.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1237117|NCT00606892|Secondary|Changes in Systolic and Diastolic Blood Pressure|The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.|30 minutes after each nicotine infusion|Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).|||mm Hg||Standard Error|Mean
1237099|NCT00607048|Secondary|Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD.|Schedule A and Schedule B: Baseline and Day 21 of every even numbered cycle up to a maximum of 8 cycles (6 months)|All response-evaluable population: included all participants who had measurable disease, a baseline tumor assessment and who started treatment were considered evaluable for analysis of tumor response.|||participants|||Number
1237100|NCT00607048|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast was estimated using non-compartmental methods on the sequence of sample measurements. Mean of individual observed AUClast values measured as nanograms multiplied by micrograms per milliliter (ng*mcg/mL).|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours post-dose up to a maximum of 8 cycles (6 months)|Pharmacokinetic data analysis set; N=number of participants who did not have pre-dose levels of CP-870893.|||hr*mcg/mL||Standard Deviation|Mean
1237101|NCT00607048|Secondary|Maximum Observed Serum Concentration (Cmax)|Mean of individual observed Cmax values measured as micrograms per milliliter (mcg/mL).|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours (hrs) post-dose up to a maximum of 8 cycles (6 months)|Pharmacokinetic data analysis set: all enrolled participants who started treatment and had baseline and sufficient on-study samples to provide interpretable results. N=number of participants who did not have pre-dose levels of CP-870893.|||mcg/mL||Standard Deviation|Mean
1237102|NCT00607048|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)|Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC <1000/mm^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr <1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC <1000 cells/mm^3 or platelets <80000 cells/mm^3, or non-hematologic toxicity ≥Gr 2.|Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21|Safety population: all participants who received at least 1 dose of study treatment.|||participants|||Number
1237103|NCT00607022|Primary|Implant Stability Scale (ISQ) Score Change After 16 Weeks|The objective of this study is to examine the change in implant stability upon three different loading regimens during the first sixteen weeks following implant placement. ISQ score (1-100), where higher score equals more stability, was assessed. The main hypotheses of the study are 1) Implant stability (ISQ) is minimally affected when physiologic load is applied to an implant during the healing process.|16 weeks||||units on a scale||Standard Deviation|Mean
1237104|NCT00606944|Secondary|Postoperative Complication||at postoperative day 30|||||||
1237105|NCT00606944|Secondary|Quality of Life|measured by SF-36|at postoperative day 30|||||||
1237106|NCT00606944|Secondary|Pain|score measured by the Visual Analog Scale|at postoperative day 30|||||||
1237107|NCT00606944|Secondary|Readmission Rate||at postoperative day 30|||||||
1237108|NCT00606944|Primary|Recovery|"recovery criteria must include all of the following~Tolerance of consecutive 3 soft bland diet~Unassisted ambulation~No necessity of analgesics~Afebrile without major complication"|at discharge|||||||
1237109|NCT00606944|Primary|Postoperative Complication During the First Admission||at discharge|||||||
1237110|NCT00606944|Primary|Quality of Life|measured by SF-36|at discharge|||||||
1237111|NCT00606944|Primary|Pain|score measured by the Visual Analog Scale|at discharge|||||||
1237112|NCT00606944|Primary|the Length of Hospital Stay|"discharge criteria~Tolerance of consecutive 3 soft bland diet~Unassisted ambulation~No necessity of analgesics~Afebrile without major complication~Willing to discharge"|at discharge|1 mortality case was excluded for analysis in the ERP group|||day||Inter-Quartile Range|Median
1237113|NCT00606931|Other Pre-specified|Number of Participants Who Tolerated the PET-Guided Biopsy Procedure|Participants who could tolerate the procedure and complete it. This was ascertained by patient feedback questionnaire asking for overall discomfort rating from 0 to 5, where 0 is no discomfort and 5 was assigned to acute discomfort that prevented subject from completing the procedure.|Within one week of completing PET-guided biopsy||||Participants|||Number
1237114|NCT00606931|Secondary|Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy|"Serious Adverse Events are defined as events that~Are fatal or life-threatening~Require in-patient hospitalization or prolong hospitalization~Result in permanent or significant disability/incapacity~Result in congenital abnormality/birth defect"|Within one week of completing PET-guided biopsy||||Participants|||Number
1237115|NCT00606931|Primary|Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.|"Success in completion of the PET guided biopsy of a suspicious lesion was determined by~Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR~Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent)."|within two days of obtaining histopathology of the lesion biopsied|All participants who completed the PET-guided biopsy for a suspicious lesions. 24 lesions were biopsied in 19 participants|||Number of lesions|||Number
1237116|NCT00606905|Primary|Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies||20 weeks gestation|47 women who achieved an index pregnancy, defined as the first pregnancy in the study, unless it resulted in a noneuploid miscarriage, ectopic, molar pregnancy or genetic termination, were analyzed.|||Successful pregnancies|||Number
1237735|NCT00603239|Secondary|Change in Fasting Serum Glucose (FSG)|Change in FSG from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||mmol/L||Standard Error|Least Squares Mean
1237118|NCT00606892|Secondary|Heart Rate|The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.|30 minutes after each nicotine infusion|Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).|||beats per minute||Standard Error|Mean
1237119|NCT00606892|Primary|Subjective Responses to Intravenous Nicotine|"The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from not at all (a score of 0) to extremely with a maximum score of 100."|30 minutes after each nicotine infusion|All participants who complete all interventions.|||millimeters||Standard Error|Mean
1237120|NCT00606892|Secondary|Cotinine Levels|Subject Cotinine Levels before each laboratory session.|Before each laboratory session on day 5|Subjects finishing the complete study. (n=12)|||ng/mL||Standard Deviation|Mean
1237121|NCT00606892|Secondary|Mean Reaction Time (RT) on Modified Stroop Task.|A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).|pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)|Data from all subjects who completed both experimental sessions (nicotine infusion after 4 days of placebo and also 4 days of varneicline, n=12) are presented. RT's < 100 ms, or > 1501 ms were excluded from the analysis (>3 SD's of the mean). The data presented are the mean RT's to identifying word colors under each treatment condition.|||milliseconds||Standard Deviation|Mean
1237122|NCT00606801|Secondary|Performance on the Modified Stroop Task (Cocaine-Stroop)|The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.|Baseline, Day 5 and Day 10||||milliseconds||Standard Deviation|Mean
1237123|NCT00606801|Secondary|Performance on the Sustained Attention to Response Task (SART).|"The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. Cocaine users are know to have deficits in response inhibition on such tasks. The number of errors on NoGo and Go trials, as well as the mean reaction time (RT in milliseconds) for correct responses on Go Trials were measured.~Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors."|Baseline, Day 5 and Day 10|Participants analyzed are those that completed the treatment phase.|||milliseconds||Standard Deviation|Mean
1237124|NCT00606801|Primary|Performance on 3 Cognitive Tests From the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP, PAL and PRM.|Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers, total hits, correct rejections and A' (sensitivity to target sequences) were determined. Paired Associate Learning (PAL) measures visual memory and new learning by testing a the ability to remember the initial location of a pattern after it is re-presented in the middle of the screen. Errors result in a reminder presentation of the original location. The stages completed and number of errors are measures of interest. Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern.|Baseline, Day 5 and Day 10|There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.|||milliseconds||Standard Deviation|Mean
1237125|NCT00606684|Secondary|Time to >= 100 Milliliter (mL) Increase From Baseline in FEV1 (0-4 Hours Post-dose)|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieve >=100 mL increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to >= 100mL increase from Baseline (on Day 1) is defined as the time until the first post-dose FEV1 (on Day 1) is >= 100mL above Baseline FEV1. Time to >= 100mL increase from Baseline (on Day 1) was calculated only if there was at least one non-missing FEV1 value recorded within the first hour of dosing. Time to >= 100mL increase from Baseline was assessed over the 0-4 time period and only used lung function data recorded up to 6 hours post the Day 1 dose. Participants who did not achieve >= 100mL increase from Baseline over this time period were censored.|Baseline and Day 1|ITT Population. Only participants available at the indicated time points were assessed.|||Minutes||Full Range|Median
1237126|NCT00606684|Secondary|Time to >= 12% Increase From Baseline in FEV1 (0-4 Hours Post-dose)|Forced expiratory volume in one second (FEV1) is a measure of lung function defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieved a >=12% increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 on Day 1.Time to >= 12% increase from Baseline (on Day 1) is defined as the time when the first post-dose FEV1 (on Day 1) is >=12% above Baseline FEV1. Time to >= 12% increase from Baseline was assessed over the 0-4 hour time period and only used lung function data recorded up to 6 hours post the Day 1 dose.|Baseline and Day 1|ITT Population. Only participants available at the indicated time points were assessed.|||Minutes||Full Range|Median
1237127|NCT00606684|Secondary|Time-adjusted Area Under the Curve (AUC) (i.e. Weighted Mean Change From Baseline) for 24 Hour Serial FEV1 on Days 1 and 28|Weighted mean was derived by calculating the AUC, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24 hour serial FEV1 measures on Day 1 and Day 28 minus the Baseline value. Serial FEV1 measurements were taken on Day 1 and Day 28 (post-dose FEV1 after 5, 15, 30 minutes and 1, 2, 4, 8, 12, 23 and 24 hours). AUC was calculated only when there was at least 3 non-missing values between 0 and 24 hours and must have a value at 23 or 24 hours. Analysis performed used a repeated measures model with covariates of treatment, baseline, sex, age, smoking status (at Screening), reversibility stratum, Day (nominal), day by Baseline, and day by treatment interactions.|Baseline to Day 28|ITT Population. The number of participants presented represents those with data available at either of time points being presented. The numbers given in the category titles represent the number of participants with data available at the time point given.|||Liters||Standard Error|Least Squares Mean
1237128|NCT00606684|Primary|Mean Change From Baseline in Trough (Pre Bronchodilator and Pre Dose) FEV1 on Day 29|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 value at Day 1. The trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24-hours after dosing on Day 28 and the Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline in trough FEV1 was calculated as the value on Day 29 minus the value at Baseline. Analysis was performed using Analysis of Covariance (ANCOVA) using Last Observation Carried Forward (LOCF) with covariates of baseline, sex, age, smoking status (at screening), reversibility stratum, and treatment (trt).|Baseline (BL) and Day 29|Intent-to-Treat (ITT) Population: all participants who were randomized to trt and received >= 1 dose of study medication. When the endpoint was missing, the last valid non-missing on-trt, post-BL trough assessment was used instead. Only those participants available at the specified time points without missing covariate information were analyzed.|||Liters||Standard Error|Least Squares Mean
1237129|NCT00606632|Secondary|Negative Predictive Value (NPV)|Negative Predictive Value (NPV) reflects the proportion of negative results that are true negatives. The NPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.|6 months|ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers|||Proportion of participants|||Number
1237130|NCT00606632|Secondary|Positive Predictive Value (PPV)|The Positive Predictive Value (PPV) reflects the Proportion of positive results that are true positive. The PPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.|6 months|ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers|||Protportion of participants|||Number
1237131|NCT00606632|Secondary|Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging|The Accuracy is the proportion of participants with correct determinations of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.|6 months|ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers|||Proportion of participants|||Number
1237132|NCT00606632|Primary|Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.|"Average estimate of three independent, blinded central readers per imaging modality on the proportion of participants that were correctly identified on the 124I-cG250 PET/CT Images of having (sensitivity) or not having (specificity) clear cell renal carcinoma (ccRCC) compared to CT images.~Histopathology provided the standard-of-truth because it is the only definitive method for accurately identifying ccRCC."|6 months|ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers|||Proportion of participants||95% Confidence Interval|Mean
1237133|NCT00606593|Secondary|Mean Total Sleep Time (TST)|"TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).~Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included)."|2 treatment nights|Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.|||minutes||Standard Deviation|Mean
1237154|NCT00606554|Primary|Duration of Weaning|Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.|Continuous (median weaning duration was 2 days)|ITT|||Days||Inter-Quartile Range|Median
1237561|NCT00603538|Secondary|Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)|IGF-BP3 is one of the IGF-axis related biomarkers.|Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment|Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.|||mg/L||Standard Deviation|Mean
1237134|NCT00606593|Primary|Mean Wake Time After Sleep Onset (WASO)|"WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake.~Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included)."|2 treatment nights|Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.|||minutes||Standard Deviation|Mean
1237135|NCT00606580|Secondary|Number of Subjects With a Relapse on or After Day 42||Day 168||||participants|||Number
1237136|NCT00606580|Secondary|Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42||Day 42|mITT dataset|||Ulcerated lesions|Participants||Number
1237137|NCT00606580|Secondary|Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse|Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward,|Day 168|mITT dataset|||participants|||Number
1237138|NCT00606580|Secondary|Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse|Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42|Day 168|mITT population|||participants|||Number
1237139|NCT00606580|Secondary|Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion||Day 42||||participants|||Number
1237140|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98||Days 98|mITT dataset|||percentage of lesions|Participants|95% Confidence Interval|Number
1237141|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49||Days 49|mITT dataset|||percentage of lesions|Participants|95% Confidence Interval|Number
1237142|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42||Days 42|mITT dataset|||Percentage of lesions|Participants|95% Confidence Interval|Number
1237143|NCT00606580|Secondary|Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up||Days 42, 49, and 98|mITT dataset. The data show that 95.8% of the Vehicle-treated subjects remaining in the study at Day 168 (the percentage excludes the 17.6% of subjects who dropped out or were withdrawn early due to treatment failure) had re-epithelialization of the index lesion.|||percentage of participants||95% Confidence Interval|Number
1237144|NCT00606580|Secondary|Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse|For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42.|Day 42|mITT dataset|||percentage of participants||95% Confidence Interval|Number
1237145|NCT00606580|Secondary|Final Clinical Cure Rate (Per Protocol Dataset)|Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure.|Day 42, 98, and 168|Per protocol – all randomized subjects who received at least one treatment of study drug and whose outcomes at Day 42, Day 98 (if applicable) and Day 168 could be assessed. However, a subject was still considered per-protocol if withdrawn early for treatment failure.|||participants|||Number
1237146|NCT00606580|Primary|Final Clinical Cure Rate|"Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows:~Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation.~Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98.~Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168.~Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse."|Day 42, 98, and 168|Modified intention-to-treat (mITT) – all subjects randomized who received at least one treatment of study drug.|||participants|||Number
1237147|NCT00606554|Secondary|Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)|This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.|Duration of weaning (median 2 days)|Number of participants with adverse event during weaning|||Participants|||Number
1237148|NCT00606554|Secondary|Number of Spontaneous Breathing Trials Prior to Extubation||from start of weaning to liberation from ventilator, on average 1-2 days||||SBTs||Inter-Quartile Range|Median
1237149|NCT00606554|Secondary|Sedation Requirements|measure was not recorded|during weaning, on average 1-2 days|Data were not recorded||||||
1237150|NCT00606554|Secondary|Inpatient Mortality|proportion of patients in each arm who died in the hospital|28 days|ITT|||Participants|||Number
1237151|NCT00606554|Secondary|Duration of Hospitalization||from start of weaning to discharge from hospital, on average 1-2 weeks||||days||Inter-Quartile Range|Median
1237152|NCT00606554|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation from weaning initiation|from start of weaning to liberation from ventilator, on average 1-2 days||||days||Inter-Quartile Range|Median
1237153|NCT00606554|Secondary|Duration of ICU Stay|Duration of ICU stay after weaning initiation|from start of weaning to discharge from ICU, on average 1-2 weeks||||days||Inter-Quartile Range|Median
1238029|NCT00600353|Secondary|Impact of Nausea and Vomiting on the Quality of Life of Patients Undergoing Autologous HSCT|To determine quality of life, subjects’ responses to the modified Osoba modules were converted to a 0 – 100 scale, with higher scores indicative of better QOL|24 hours, Day 3, Day 7|||||||
1237155|NCT00606502|Secondary|Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib||Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).|"Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Pralatrexate or Erlotinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.~Grade 3 = Severe~Grade 4 = Life-threatening or disabling"|||Treated Participants|||Number
1237156|NCT00606502|Secondary|Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib|PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.|Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.|Patients who were alive without a disease response assessment of PD as of the data cut-off date were censored at the last disease assessment date or the date of randomization, whichever was later. Patients with no response assessments after baseline were censored at date of randomization resulting in a duration of PFS of 1 day.|||months||95% Confidence Interval|Median
1237157|NCT00606502|Secondary|Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib|Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).|Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.|Based on all treated patients with measurable disease at baseline. Patients who were declared unevaluable for response were considered nonresponders and were included in the calculation of response rate. Patients were unevaluable if they were off-treatment prior to first response assessment, never received treatment or had unconfirmed responses.|||Participants|||Number
1237158|NCT00606502|Primary|Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib|OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.|Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.||||Months Survival||95% Confidence Interval|Median
1237159|NCT00606489|Primary|Temperature|Area under the curve temperature from baseline to hour 24 following initiation of treatment.|0 to 24 hours|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.|||Degree Celcius times hours (AUC-T)||Standard Error|Least Squares Mean
1237160|NCT00606320|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)|"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).~Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group."|Baseline (Day 1 of preceding study) , Day 154 or at discontinuation||||scores on a scale||Standard Deviation|Mean
1237161|NCT00606320|Primary|Young Mania Rating Scale (YMRS)|YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated.|baseline (Day 1 of preceding study), Day 154 or at discontinuation||||scores on a scale||Standard Deviation|Mean
1237162|NCT00606281|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania)|"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness.~CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).~Using LOCF datasets, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA."|Day1, Day21|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.|||scores on a scale||Standard Error|Least Squares Mean
1237163|NCT00606281|Primary|Young Mania Rating Scale (YMRS)|"Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA).~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)."|Day1, Day21|Full analysis set (FAS): The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.|||scores on a scale||Standard Error|Least Squares Mean
1237164|NCT00606229|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)|"Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania)~The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill)"|Day 1 and Daty 168 or time of discontinuation|Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)|||scores on a scale||Standard Deviation|Mean
1237180|NCT00606021|Secondary|Number of Participants With Adverse Events (AEs) During Overall Period|The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.|First dose of study drug during IP through overall study completion (up to 34.3) months|Participants who took at least one dose of study drug during IP, and randomized to maintenance phase.|||participants|||Number
1237165|NCT00606229|Primary|Young Mania Rating Scale (YMRS)|"Mean change from baseline (Day 1) to endpoint in the YMRS total score~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~Total score range is 0 to 60, and the higher value represents worsen."|Day 1 and Day 168 or time of discontinuation|Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)|||scores on a scale||Standard Deviation|Mean
1237166|NCT00606177|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)|"Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group.~CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness.~CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill)."|Baseline (Day 1 of preceding study), Day 154 or at discontinuation|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.|||scores on scale||Standard Deviation|Mean
1237167|NCT00606177|Primary|Young Mania Rating Scale (YMRS)|"Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group.~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)."|Baseline (Day 1 of preceding study) , Day 154 or at discontinuation|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.|||scores on a scale||Standard Deviation|Mean
1237168|NCT00606138|Secondary|Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment||Month 6||||number of PDR complications|||Number
1237169|NCT00606138|Secondary|Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing||Week 1, 2, 4; Month 2, 3, 4, 5, 6|||||||
1237170|NCT00606138|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters||Week 4; Month 6||||lines of vision gained||Standard Deviation|Mean
1237171|NCT00606138|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||Week 1, 2, 4; Month 2, 3, 4, 5, 6|||||||
1237172|NCT00606138|Primary|Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination||Month 6||||number of events|||Number
1237173|NCT00606138|Primary|The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)||Week 4; Month 6||||percentage of change (mean)||Standard Deviation|Mean
1237174|NCT00606138|Primary|The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)|This is a measurement of how much change in neovascularization has occurred, using the Optomap FA readings to calculate the increase or decrease in surface area of the retina that is affected by neovascularization.|Week 4; Month 6||||percentage of change in area (mean)||Standard Deviation|Mean
1237175|NCT00606086|Primary|EVR (Early Virologic Response)|Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.|At 12 weeks of treatment|One hundred forty subjects were randomized, only 133 subjects received at least one dose of study drug. Subjects who did not receive at least one dose of study drug were removed from the analysis.|||percentage of participants|||Number
1237176|NCT00606034|Secondary|Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)|Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.|Baseline versus 1 year|per protocol|||percent satisfaction||Standard Deviation|Mean
1237177|NCT00606034|Secondary|Percentage of Time Spent in Hypoglycemia|For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.|baseline versus 12 months|ITT (LOCF for 1 subject)|||percent of time spent in hypoglycemia||Standard Deviation|Mean
1237178|NCT00606034|Primary|Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)|HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.|1 year|Per Protocol|||HbA1c percentage||Standard Deviation|Mean
1237179|NCT00606021|Secondary|Tumor Response Rate and Disease Control Rate After Induction Phase (IP)|Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Randomization to measured PD up to 31.4 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.|||percentage of participants||95% Confidence Interval|Number
1237181|NCT00606021|Secondary|Overall Survival During Overall Period (IP + MP)|Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.|First dose of study drug during IP to PD or date of death from any cause up to 34.1 months|Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.|||months||95% Confidence Interval|Median
1237182|NCT00606021|Secondary|Overall Survival During Maintenance Phase|Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.|Randomization to PD or date of death from any cause up to 31.3 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.|||months||95% Confidence Interval|Median
1237183|NCT00606021|Secondary|Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])|Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.|First dose of study drug during IP to PD or date of death from any cause up to 33.6 months|Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.|||months||95% Confidence Interval|Median
1237184|NCT00606021|Primary|Progression Free Survival During Maintenance Phase|Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.|Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.|||months||95% Confidence Interval|Median
1237185|NCT00606008|Secondary|Number of Participants With Related Grade 3 and Greater Adverse Events|To evaluate toxicities associated with sunitinib treatment (grade 3 and greater toxicities).|12 Months|All participants|||Participants|||Number
1237186|NCT00606008|Secondary|Best Overall Response|To estimate best response rates (proportion of patients who ever had a radiographic response equal to or better than stable disease during course assessment).|12 Months|All participants|||Participants|||Number
1237187|NCT00606008|Primary|Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse|Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.|6 Months|All participants|||Participants|||Number
1237188|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Drinking Status|Number of participants with responders of Sertraline to determine whether drinking status is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237189|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Complication|Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237190|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug|Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237191|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237192|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237193|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237194|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of was confirmed.|||participants|||Number
1237195|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without past medical history of other illness is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237196|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237197|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237198|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237199|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237200|NCT00605917|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||events|||Number
1237201|NCT00605917|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.|||participants|||Number
1237202|NCT00605904|Primary|Alcohol Craving Rating in Response to Yohimbine Infusion|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)|||Units on a scale||Standard Error|Mean
1237203|NCT00605904|Primary|Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)|||Units on a scale||Standard Error|Mean
1237204|NCT00605904|Primary|Alcohol Craving Rating in Response to Saline Infusion|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)|||Units on a scale||Standard Error|Mean
1237205|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)|Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237206|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Age|Number of participants with responders of Sertraline to determine whether age is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237562|NCT00603538|Secondary|Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers.|Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study|Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.|||ng/L||Standard Deviation|Mean
1237207|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not|Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237208|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.|Number of participants with responders of Sertraline to determine whether with or without complication is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237209|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient|Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237210|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride|Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237211|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity|Number of participants with responders of Sertraline to determine whether target disease severity is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237212|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237213|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237214|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237215|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237216|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237217|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237218|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237219|NCT00605865|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||events|||Number
1237220|NCT00605865|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 16 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.|||participants|||Number
1237221|NCT00605839|Primary|Quality of Parent-child Relationship|The Cornell Parent Behavior Description Scale was used to measure the antecedents and consequences of children’s perceptions of the behavior of their parents towards them. Each of 14 subscales is scored from 0-10. The potential range of the total score is therefore 0 (fewest behaviors) to 140 (most behaviors). We used the total score, which is equivalent to the sums of the subscales, and calculated the change from baseline to 6 months. The range of the change is given as a 95% CI. A change of zero would indicate no change. A positive number is a worsening , and a negative number indicates an improvement.|Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.|Everyone who completed the study|||units on a scale||95% Confidence Interval|Mean
1237222|NCT00605813|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)|Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237223|NCT00605813|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies|Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1237224|NCT00605813|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237225|NCT00605813|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
1237226|NCT00605813|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 52 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Sertraline.|||events|||Number
1237227|NCT00605813|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||events|||Number
1237228|NCT00605722|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Up to 107 Weeks|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
1237229|NCT00605722|Secondary|Overall Survival (OS)|OS was defined as the time period in months from the start of study drug treatment to death.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.|||months||95% Confidence Interval|Median
1237230|NCT00605722|Secondary|Progression-free Survival (PFS)|PFS was defined as the time period in months from the start of study drug treatment to the first of either progression or death. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug. Participants were censored at the last follow-up visit.|||months||95% Confidence Interval|Median
1237231|NCT00605722|Secondary|Time to Tumor Progression|Time to tumor progression was defined as the time period in months from the start of study drug treatment to disease progression. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.|||Months||95% Confidence Interval|Median
1237232|NCT00605722|Secondary|Disease Control Rate (DCR)|Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 8 weeks by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.|||Percentage of participants||95% Confidence Interval|Number
1237233|NCT00605722|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR). Analysis of tumor response was based on the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST), which was defined as the best response recorded from the start of trial treatment until disease progression/recurrence (or death), taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD required at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.|||percentage of participants||95% Confidence Interval|Number
1237234|NCT00605722|Primary|Percentage of Participants With Progression-free Survival (PFS)|Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug. Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Week 16|Intent-to-treat population included all participants who received study drug. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease.|||percentage of participants||95% Confidence Interval|Number
1237235|NCT00605696|Secondary|Murray Lung Injury Score|Murray Lung Injury Score is a continuous score that quantifies the severity of lung injury and consist of components related to severity of hypoxia, pulmonary compliance, peep, and radiologic abnormalities. The scores range between 0 - 4. The higher the score, the greater the degree and severity of lung injury. The scale runs from 0-4, with 0 being the minimum and 4 the maximum score.|Measured at Day 3|Change in Murray Lung Injury score from Day 3 to Day 0 (baseline)|||units on a scale||Standard Deviation|Mean
1237236|NCT00605696|Primary|Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen||Measured at Day 1, 3 and 7|Although blood samples were collected, there were no bioassays perfomed and therefore no data were collected from any study participants.||||||
1237237|NCT00605657|Secondary|To Determine Whether the Treatment Alters, in Favorable Directions, Laboratory Markers of ALPS (e.g., Number of DNT Cells, Immunoglobin Levels, Vitamin B12 Levels, IL-10 Levels, Autoantibody Titers, Fas Mediated Apoptosis)||3 monthly (12 week) intervals|outcome measure not assessed because 0 participants had a response||||||
1237238|NCT00605657|Primary|Number of Participants With Response|Reduction of lymph node and/or spleen size measured by CT imaging, or physical exam and abdominal ultrasound. A clinical response is defined as a greater than 40% reduction in lymph node size and/or greater than 40% reduction in spleen size. A CT scan with contrast measured lymph node size as well as spleen size.|3 monthly (12 week) intervals||||participants|||Number
1237239|NCT00605540|Primary|Health Status|Saint George’s Respiratory Questionnaire (SGRQ)was used to evaluate patient's health status. SGRQ includes three domains: symptoms, activities and impact of the disease. Each domain has a minimum score (zero) and maximum (662.5, 1209.1, and 2117.8, respectively). A total score is also calculated based on the results of three domains, with a score maximum of 3989.4. The total score is referred to as the percentage achieved by the patient related to this maximum score. Minimum score means there is no impairment in the health status and high score means maximum dysfunction.|Baseline and after three years||||Percentage of total score||Standard Deviation|Mean
1237240|NCT00605540|Primary|Dyspnea|Dyspnea was evaluated by Medical Research Council scale (MRC). MRC scale consists of only five items and it is based on activities that cause dyspnea. The patient reports the degree of dyspnea by choosing a value between 1 and 5. A higher number indicates greater sensation of dyspnea.|Baseline and after three years||||Scores on a scale||Inter-Quartile Range|Median
1237241|NCT00605540|Primary|Body Composition|Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.|Baseline and after three years||||Kg/m^2||Inter-Quartile Range|Median
1237242|NCT00605540|Primary|Exercise Tolerance|Tolerance exercise was evaluated by six-minute walking distance(6MWD)according to the American Thoracic Society guidelines.Patients were instructed to walk, attempting to cover as much ground as possible within 6 min. A research assistant timed the walk, and standardized verbal encouragement was given.|Baseline and after three years||||meters||Standard Deviation|Mean
1237243|NCT00605540|Primary|Forced Expiratory Volume in the First Second (FEV1)|FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.|Baseline and after three years|The sampling frame for this study was consecutive COPD patients recruited from the outpatient clinic of Botucatu Medical School.|||Percentage predicted||Inter-Quartile Range|Median
1237244|NCT00605475|Secondary|Number of Participants Reporting Death, Serious Adverse Events (SAEs), Adverse Events (AE) Above 5% Frequency|An adverse event is any unwanted event, whether related to study drug or not occurring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.|Baseline to End of Study (56[+/-2] and 168 [+/- 5] days after dosing for Cohort 1 and Cohorts 2-4, respectively)|All randomized participants who received study medication were included in the Safety Analysis|||Participants|||Number
1237254|NCT00605475|Primary|Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )|Mean Change in Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Glucose levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||mmol*h/L||Standard Error|Least Squares Mean
1237245|NCT00605475|Secondary|β-cell Function as Measured by the Homeostatic Model Assessment (HOMA-β )|β cell function is measured by the Homeostatic Model Assessment(HOMA-β) using a computer to model β cell function and insulin sensitivity . β cell function is related to Insulin Sensitivity (HOMA-%S) and is the reciprocal of insulin resistance (100/S%). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) – 3.5] where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||percent β-cell Function||Standard Error|Geometric Mean
1237246|NCT00605475|Secondary|Insulin Resistance as Measured by the Homeostatic Model Assessment (HOMA-IR)|Insulin Resistance is measured via the Homeostatic Model Assessment (HOMA-IR) using a computer to model insulin sensitivity. Insulin Sensitivity (HOMA-%S), where 100% is normal, is the reciprocal of insulin resistance (100/S%). HOMA IR = [fasting insulin (μU/mL)] x [fasting plasma glucose (mmol/L)] / 22.5 where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||units on a scale||Standard Error|Geometric Mean
1237247|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Fructosamine Level|Blood was drawn to measure change in plasma Fructosamine Level, from baseline to Day 14, 28, 56, 84, 126 and End of Study ( defined as the final available post-randomization assessment up to the last regularly scheduled visit at Day 168 [+/- 5]). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 14, Day 28, Day 56, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||µmol/L||Standard Error|Least Squares Mean
1237248|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Glucose Following Oral Glucose Tolerance Test ( OGTT )|Mean Change in Peak Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Change from baseline assessed at Day 28 and 84. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||mmol/L||Standard Error|Least Squares Mean
1237249|NCT00605475|Secondary|Insulinogenic Index, 0 - 30 Minutes|"Insulinogenic index (0-30 min)~[Change in insulin (0-30 min) (μIU/mL)] / [Change in glucose (0-30 min) (mg/dL)]~[insulin (μIU/mL) at 30 min – insulin (μIU/mL) at 0 min] / [glucose (mg/dL) at 30 min – glucose (mg/dL) at 0 min), where insulin (or glucose) at 0 min was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.."|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||units on a scale||Standard Error|Geometric Mean
1237250|NCT00605475|Secondary|Insulin Sensitivity Index ( ISI ) at Day 28, Day 48|Insulin sensitivity index (ISI) = 10000 / [fasting insulin (μIU/mL) x fasting glucose (mg/dL) x mean 2 hour insulin(μIU/mL) x mean 2 hour glucose (mg/dL)]1/2 where mean 2 hour insulin (or glucose) was defined as the insulin (or glucose)AUC(0-2 hr) divided by the time period (2 hr). In normal subjects the mean score ± SE is 0.366 ± 0.029. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||units on a scale||Standard Error|Geometric Mean
1237251|NCT00605475|Secondary|Mean Insulin Secretion Rate ( ISR ), 0 - 4 Hours|Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. The mean ISR over 0 - 4 hours was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol/min/m^2||Standard Error|Least Squares Mean
1237252|NCT00605475|Secondary|Mean Insulin Secretion Rate ( ISR ) Relative to Glucose, 0 - 4 Hours|"Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Mean ISR relative to glucose over 0-4 hours was calculated as follows:~Mean ISR relative to glucose = mean ISR / (glucose AUC/time interval). The mean ISR was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed."|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
1237253|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin and proinsulin levels were measured. The insulin/proinsulin level was calculated by dividing the insulin level by the proinsulin level. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol/pmol||Standard Error|Least Squares Mean
1237381|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein at Week 12|Clinical chemistry parameters included albumin and total protein. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram per Liter||Standard Deviation|Mean
1237255|NCT00605475|Secondary|Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Glucagon levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol*h/L||Standard Error|Least Squares Mean
1237256|NCT00605475|Secondary|Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol*h/L||Standard Error|Least Squares Mean
1237257|NCT00605475|Secondary|Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||µIU*h/mL||Standard Error|Least Squares Mean
1237258|NCT00605475|Primary|Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)|Blood was drawn after an overnight fast to measure plasma HbA1c levels. End of Study is defined as the last Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||percent||Standard Error|Least Squares Mean
1237259|NCT00605475|Secondary|Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)|Blood samples were drawn after an overnight fast and standard OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. C-peptide levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol*h/L||Standard Error|Least Squares Mean
1237260|NCT00605423|Secondary|Change in IOP From Baseline|IOP stands for intra ocular pressure|6 mos||||mmHg||Standard Deviation|Mean
1237261|NCT00605423|Secondary|Number of Patients Developing Cataracts||6 mos||||participants|||Number
1237262|NCT00605423|Primary|Mean Change From Baseline in Visual Acuity|Visual acuity is measured using ETDRS charts at 4 meters.|6 mos||||ETDRS letters||Standard Deviation|Mean
1237263|NCT00605384|Secondary|Number of Participants With Genotypic Resistance Based on Analysis of Samples From Participants With HBV DNA ≥ 50 IU/mL at Weeks 48 and 96|HBV DNA ≥ 50 IU/mL = approximately 300 copies/mL|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
1237264|NCT00605384|Secondary|Number of Participants With HBs Seroconversion (HBsAg Loss and Presence of HBsAb) at Weeks 48 and 96|Hepatitis B surface antigen (HBsAg) = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAb = HBsAg antibodies. HBs Seroconversion = HBsAg loss and presence of HBseAb|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
1237265|NCT00605384|Secondary|Number of Participants With Hepatitis-B-Virus Surface Antigen of the (HBsAg) Loss at Weeks 48 and 96|Hepatitis B surface antigen (HBsAg) = a part of the hepatitis B virus that, when in the blood, is an early marker of infection|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
1237266|NCT00605384|Secondary|Number of Participants Who Were HBeAg-positive at Baseline With HBe Seroconversion at Weeks 48 and 96|HBe seroconversion = HBeAg loss and presence of hepatitis B e-antibody (HBeAb)|Baseline, Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
1237267|NCT00605384|Secondary|Number of Participants Who Were Hepatitis B E-antigen (HBeAg)-Positive at Baseline With Loss of HBeAg at Weeks 48 and 96|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication.|Baseline, Week 48, Week 96|Due to early study termination, none of the efficacy endpoints was analyzed.|||Participants|||Number
1237268|NCT00605384|Secondary|Number of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieved ALT Normalization (≤ 1 x ULN) at Weeks 48 and 96||Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||Participants|||Number
1237269|NCT00605384|Secondary|Mean log10 Reduction From Baseline in HBV DNA at Weeks 48 and 96|by PCR, using the Roche COBAS®TaqMan - HPS assay|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints was analyzed.|||log10||Standard Deviation|Mean
1237270|NCT00605384|Secondary|HBV DNA Values at Weeks 48 and 96|Number of Participants with HBV DNA <LLD (4.8); LLD to <50; 50 to <172; 172 to <1,720; 1,720 to <17,200; and ≥17,200 IU/mL (<LLD (28); 28 to <300; 300 to <1,000; 1,000 to <10,000; 10,000 to <100,000; and ≥100,000 copies/mL by PCR, using the Roche COBAS®TaqMan - HPS assay|Weeks 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
1237271|NCT00605384|Secondary|Number of Participants Who Achieved HBV DNA < the Lower Limit of Detection (LLD) at Weeks 48 and 96|by PCR, using the Roche for the Roche COBAS® TaqMan - HPS assay. LLD = 4.8 IU/mL (approximately 28 copies/mL)|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
1237420|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)|||participants|||Number
1237272|NCT00605384|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.|Day 1 through end of treatment (Week 100 +/- 5 days)|All treated participants. Timeframe for Outcome Measure revised due to study termination. (Study Completion Date=February 2009).|||participants|||Number
1237273|NCT00605384|Secondary|Number of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 96|by PCR, using the Roche COBAS®TaqMan - HPS assay; HBV DNA < 50 IU/mL = approximately 300 copies/mL.|Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
1237274|NCT00605384|Primary|Number of Participants Who Achieved an Hepatitis B Virus DNA (HBV DNA) Level < 50 IU/mL at Week 48|using the Roche COBAS® TaqMan HBV Test for use with the High Pure System (HPS) assay, by Polymerase Chain Reaction (PCR); HBV DNA < 50 IU/mL = approximately 300 copies/mL|Week 48|Due to early study termination, none of the efficacy endpoints were analyzed.|||Participants|||Number
1237275|NCT00605358|Primary|The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression.|"Engagement was defined as at least one visit with a mental health provider, due to the fact that in some treatment settings, the initial evaluation and the onset of treatment both took place in the first visit.~The primary outcome, engagement, was counted if the participant had engaged in mental health treatment by EITHER 12 weeks OR 24 weeks, based on research suggesting that older adults may take up to 6 months to follow through on a referral.~Therefore, while there is only a single primary outcome (engaged or not), it could be fulfilled at either of the two follow-up time points, at 12 or 24 weeks."|12 and 24 weeks||||percentage of participants|||Number
1237276|NCT00605345|Secondary|Incidence of RBC Transfusions|Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).|Up to 28 weeks|Analysis performed with the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.|||participants|||Number
1237277|NCT00605345|Secondary|Percentage of Participants Needing Dose Adjustments|Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).|Up to 28 weeks|Analysis was performed on the safety population.|||percentage of participants|||Number
1237278|NCT00605345|Secondary|Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)|Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.|Weeks 16-28|Analysis was performed using the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.|||days||Standard Deviation|Mean
1237279|NCT00605345|Secondary|Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)||Weeks 16-28|Analysis performed with intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.|||percentage of participants|||Number
1237280|NCT00605345|Secondary|Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)|Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.|Baseline to 28 weeks|Analysis performed in the Intent toTreat (ITT) population, which includes all participants receiving at least one dose of the study drug.|||g/dL||Standard Deviation|Mean
1237281|NCT00605345|Primary|The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range|Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 – 12 g/dL.|Weeks 16-28|Analysis was performed in the per protocol (PP) population.|||percentage of participants||95% Confidence Interval|Number
1237282|NCT00605319|Primary|Postvoid Residual Volume (PVR)|Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.|screening (Month 0), 2-months, 3-months, 7-months||||mL||Standard Deviation|Mean
1237283|NCT00605319|Primary|Average Flow Rate (Qavg)|Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time|screening (Month 0), 2-months, 3-months, 7-months||||mL/s||Standard Deviation|Mean
1237284|NCT00605319|Primary|Maximum Flow Rate (Qmax)|Urodynamics was used to meause maximum flow rate (Qmax) which is the maximum recorded flow rate of urinary|screening (Month 0), 2-months, 3-months, 7-months||||mL/s||Standard Deviation|Mean
1237285|NCT00605319|Primary|International Prostate Symptom Score (IPSS) Quality of Life (QoL)|IPSS Quality of Life (QoL) is one question used to assess how the patient's symptoms affect their quality of life. A score ranges from 1 to 6, with 6 being the worse outcome.|screening (Month 0), 2-months, 3-months, 7-months||||units on a scale||Standard Deviation|Mean
1237286|NCT00605319|Primary|IPSS Nocturia|International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with nocturia meaning individuals who wake up during sleeping hours to urinate.|screening (Month 0), 2-months, 3-months, 7-months||||units on a scale||Standard Deviation|Mean
1237421|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)|||participants|||Number
1237287|NCT00605319|Primary|IPSS Irritative|International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with irritative symptoms which includes frequency, urgency, nocturia and urge incontinence|screening (Month 0), 2-months, 3-months, 7-months||||units on a scale||Standard Deviation|Mean
1237288|NCT00605319|Primary|IPSS Obstructive|International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with obstructive symptoms which includes hesitancy or difficulty initiating the stream, straining to void, a reduced flow, an intermittent stream or a sensation of incomplete emptying.|screening (Month 0), 2-months, 3-months, 7-months||||units on a scale||Standard Deviation|Mean
1237289|NCT00605306|Secondary|Levels of Serum Cortisol Over Time|At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants|||mmol/L||Standard Deviation|Mean
1237290|NCT00605306|Secondary|Levels of Plasma Glucose Over Time|At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants|||mmol/L||Standard Deviation|Mean
1237291|NCT00605306|Secondary|Levels of Serum Potassium Over Time|At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants|||mmol/L||Standard Deviation|Mean
1237292|NCT00605306|Primary|Participants With Adverse Events|"An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention.~A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above."|15 days|All participants|||participants|||Number
1237293|NCT00605293|Secondary|Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP|RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).|DTP (Week 0 to 15) up to EEP (Week 16 to 23)|ITT population|||percentage of participants|||Number
1237294|NCT00605293|Secondary|Percentage of Participants Who Required Dose Adjustments During the DTP and EEP||DTP (Week 0 to 15) and EEP (Week 16 to 23)|"Safety population included all those participants who were treated with at least one dose of the trial medication and had a safety follow-up, whether withdrawn prematurely or not. Here, n = participants who were evaluable for each category, for respective arm groups."|||percentage of participants|||Number
1237295|NCT00605293|Secondary|Mean Time Spent in Hb Range 10-12 g/dL||SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)|ITT population. Here, n = participants who were evaluable for each category, for respective arm groups.|||days||Standard Deviation|Mean
1237296|NCT00605293|Secondary|Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP|Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.|EEP (Week 16 to 23)|ITT population|||percentage of participants|||Number
1237297|NCT00605293|Secondary|Change in Hb Concentrations Between Baseline SVP and the EEP|Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).|SVP (Week -4 to -1), EEP (Week 16 to 23)|ITT population.|||g/dL||Standard Deviation|Mean
1237298|NCT00605293|Primary|Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP|Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.|EEP (Week 16 to 23)|Per Protocol (PP) population was as a subset of the ITT population who completed the study without any major protocol deviations.|||percentage of participants||95% Confidence Interval|Number
1237299|NCT00605280|Secondary|Number of Participants Requiring Focal or Grid Laser Treatment During Year 2|Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation|2 years|FAS2 population|||Participants|||Number
1237300|NCT00605280|Secondary|Number of Participants Requiring Focal or Grid Laser Treatment During Year 1|Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation|1 year|MITT1 population|||Participants|||Number
1238134|NCT00599313|Secondary|Change of PSA Doubling Time|Difference of PSA doubling time between baseline and end of the treatment.|Baseline and up to 12 months|Patients who had measurements of prior and post doubling time.|||months||Full Range|Median
1237301|NCT00605280|Secondary|Change From Baseline in Mean VA Score at 2 Years|Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.|Baseline, Year 2|FAS2 population. LOCF.|||Scores on a scale||Standard Deviation|Mean
1237302|NCT00605280|Secondary|Change From Baseline in Mean VA Score at 1 Year|Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.|Baseline, Year 1|MITT1 population. LOCF.|||scores on a scale||Standard Deviation|Mean
1237303|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.|Baseline, Year 2|FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.|||Eyes|||Number
1237304|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.|Baseline, Year 2|FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.|||Eyes|||Number
1237305|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.|Baseline, Year 1|Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.|||Eyes|||Number
1237306|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year|Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.|Baseline, Year 1|Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.|||Eyes|||Number
1237307|NCT00605280|Secondary|Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 2|FAS2 population. LOCF.|||Participants|||Number
1237308|NCT00605280|Secondary|Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 1|MITT1 population. LOCF.|||Participants|||Number
1237309|NCT00605280|Secondary|Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 2|Full Analysis Set (FAS)2 population:participants who had same treatment for 102 weeks (pegaptanib sodium or sham on/before Week 96) with baseline VA assessment, who met the following: had at least 1 post baseline VA within 2 years, before entry into the Year 3 open-label extension phase, or before withdrawing from the study prior to Week 102. LOCF.|||Participants|||Number
1237310|NCT00605280|Primary|Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year|Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts|Baseline, Year 1|Modified Intent-to-Treat (MITT)1 population:participants with at least 1 dose of study treatment who completed baseline VA, had at least 1 post baseline VA assessment within 1 year; 2 sites not analyzed due to Good Clinical Practice deviations; the 0.03 and 0.003mg pegaptanib arms not analyzed for efficacy. Last Observation Carried Forward (LOCF).|||Participants|||Number
1237311|NCT00605267|Secondary|Anastrozole Plasma Concentrations (Cmin)|Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.|Assessed at week 12||||ng/mL||Full Range|Geometric Mean
1237312|NCT00605267|Secondary|Endocrine Subscale (ES)|"Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.~Score range: 0-72"|Assessed at baseline and after 24 weeks of treatment|Difference of Endocrine Subscale (ES) = ES at 24 weeks – ES at baseline.|||ES score||Standard Deviation|Mean
1237329|NCT00605189|Primary|Compare Energy Charge Between Wound Treatment Therapies|"Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit.~Energy Charge is calculated as follows:~Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP)~Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate"|Day 0, Day 2, Day 7|Energy charge data was not available for all subjects on the study. Data was only recorded for the subjects listed above.|||Ratio||Standard Deviation|Mean
1238783|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Hepato-/Gastrointestinal’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1237313|NCT00605267|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B)|"Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.~FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).~Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.~Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI."|Assessed at baseline and after 24 weeks of treatment|"Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.~PWB, FWB and BCS were assessed in this study. TOI was a total of PWB, FWB and BCS."|||Trial Outcome Index (TOI) (Prorated)||Standard Deviation|Mean
1237314|NCT00605267|Secondary|Histopathological Response Rate (HRR)|Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)|Assessed at baseline and after 24 weeks of treatment||||Percentage of Participants|||Number
1237315|NCT00605267|Secondary|Human Epidermal Growth Factor Receptor 2 (HER2) Status|HER2 status in the ITT population is categorized as Positive or Negative|Assessed at baseline and after 24 weeks of treatment||||Participants|||Number
1237316|NCT00605267|Secondary|Progesterone Receptor (PgR) Status|PgR status in the ITT population is categorized as Positive or Negative.|Assessed at baseline and after 24 weeks of treatment||||Participants|||Number
1237317|NCT00605267|Secondary|Oestrogen Receptor (ER) Status|ER status in the ITT population is categorized as Positive or Negative|Assessed at baseline and after 24 weeks of treatment||||Participants|||Number
1237318|NCT00605267|Secondary|Serum Oestradiol (E2) Concentrations|Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.|Assessed at baseline and after 24 weeks of treatment||||Ratio||Standard Deviation|Mean
1237319|NCT00605267|Secondary|Serum Oestrone (E1) Concentrations|Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.|Assessed at baseline and after 24 weeks of treatment||||Ratio||Standard Deviation|Mean
1237320|NCT00605267|Secondary|Bone Turnover Marker (NTX)|Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks|Assessed at baseline and after 24 weeks of treatment||||nmolBCE(Bone Collagen Equivalent) /L||Standard Deviation|Mean
1237321|NCT00605267|Secondary|Bone Turnover Marker (BAP) CLEIA Method|Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method|Assessed at baseline and after 24 weeks of treatment||||ug/L||Standard Deviation|Mean
1237322|NCT00605267|Secondary|Bone Turnover Marker (BAP) EIA Method|Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method|Assessed at baseline and after 24 weeks of treatment||||U/L||Standard Deviation|Mean
1237323|NCT00605267|Secondary|Bone Mineral Density (BMD) Cervical Thighbone|Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone.|Assessed at baseline and after 24 weeks of treatment|Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks – BMD percentage at baseline|||PercentageBMD=Patient'sBMD/standard BMD)||Standard Deviation|Mean
1237324|NCT00605267|Secondary|Bone Mineral Density (BMD) Lumbar Spine|Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.|Assessed at baseline and after 24 weeks of treatment|The standard BMD value is defined by Japanese Osteoporosis Society in the table of reference values showing the mean for the age, gender, race, skeletal site, and densitometer measurement units was used. Then the formula was used at each measurement data: BMD(%) = Patient's BMD / standard BMD) x 100|||PercentageBMD=Patient's BMD/standard BMD||Standard Deviation|Mean
1237325|NCT00605267|Primary|Best Overall Response Rate (BORR) (MRI/CT)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement).~CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks||||Percentage of Participants|||Number
1237326|NCT00605267|Primary|Best Overall Response Rate (BORR) (US)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement).~CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks||||Participants|||Number
1237327|NCT00605267|Primary|Best Overall Response Rate (BORR) (Calliper)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).~CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period.~At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter"|||Percentage of Participants|||Number
1237328|NCT00605202|Primary|Plasma Potassium|Plasma potassium measured with indirect ion specific electrode method|Baseline and 2 weeks||||mmol/l||Standard Deviation|Mean
1237365|NCT00604825|Secondary|Change From Baseline in Glucose at Week 12|Pharmacodynamic marker included glucose. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Deviation|Mean
1237330|NCT00605176|Secondary|Local Skin Reactions|Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each study visit. These included: Erythema, Edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Mean scores were summated over time (14 weeks) to yield a mean LSR AUC (area under the curve)|At all visits - from Baseline to End of study (Week 14)|All participants were evaluated for local skin reactions (LSR) at every visit. Summary of LSR - area under the curve (AUC) of sum of LSR Scores (days). ITT population. The time period for the AUC extends to 8 weeks after the end of treatment (Week 14). Only subjects who received treatment in both treatment cycles are included in this analysis.|||units on a scale * days||Standard Deviation|Mean
1237331|NCT00605176|Secondary|Percent Change From Baseline in AK Lesion Count|Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions.|From baseline to End of Study the Week 14 visit|Intent to treat (ITT) Last Observation Carried Forward (LOCF)|||percent change||Full Range|Median
1237332|NCT00605176|Secondary|Number of Participants With Partial Clearance of AK Lesions|Subject status with respect to partial clearance of AK lesions at end of study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.|End of Study the Week 14 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).|||participants|||Number
1237333|NCT00605176|Primary|Number of Participants With Complete Clearance of AK Lesions|Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or ‘subclinical’ lesion that had not been identified at Baseline.|End of Study the Week 14 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF, primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).|||participants|||Number
1237334|NCT00605150|Secondary|Occurrence of Unacceptable Side Effects After Treatment||6 months|||||||
1237335|NCT00605150|Primary|Progression|Progression of liver cancer|6 months|Number of participants enrolled|||participants|||Number
1237336|NCT00605085|Secondary|SCR and GMT of Subjects With Concomitant Vaccinations||until Day 56|||||||
1237337|NCT00605085|Secondary|Changes in Laboratory Parameters||until Day 56|||||||
1237338|NCT00605085|Secondary|Rates of Serious Adverse Events and Medically Attended Adverse Events||until Day 56|||||||
1237339|NCT00605085|Primary|Safety and Tolerability up to Day 56|calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)|Day 56|Safety Population|||percentage of participants with AEs|||Number
1237340|NCT00605072|Primary|Cognitive Assessment: Forward Digit Span Test|This test consists of series of digits of increasing length, some of which are recited as presented, and some of which are to be recited in reversed order. The forward digit span score ranges from 0 (ie cannot repeat two digits) to 8 ( participant can repeat up to 8 digits)|Baseline-12 months||||number of digits repeated||Standard Error|Least Squares Mean
1237341|NCT00605072|Primary|Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall|This is a 12-item list learning test in which individuals are presented three learning and recall trials followed by a delayed recall and 24 item recognition test. The HVLT-R has been identified as an ideal memory measure for elderly patients, and appropriate reliability and validity have been shown in older individuals. The test score is the number of correct answers in the delayed recall ( score range 0-12)|Baseline-12 months||||number words remembered||Standard Error|Least Squares Mean
1237342|NCT00605072|Secondary|Blood Flow Velocity, Sitting|This reports the change in the least square mean from baseline to 12 months, adjusted for age|Baseline-12 months||||cm/sec||Standard Error|Least Squares Mean
1237343|NCT00605072|Secondary|Blood Pressure Outcome: Systolic BP|Blood pressure was measured as follows: the participant was in the sitting position, rested for 5 minutes, no caffeine or smoking 2 hours prior to measurement, using appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference), correct cuff placement (1-2 inches above brachial pulse on bare arm), and the bell of the stethoscope. The systolic blood pressure was defined as the pressure corresponding to the first korotkoff sounds (K1) and the diastolic as the pressure corresponding to the last korotkoff sound (K5). Blood pressure was measured in both arms and recorded|Baseline-12 months||||mm Hg||Standard Error|Least Squares Mean
1237344|NCT00605072|Primary|Cognitive Assessment: Trail Making Test Part B|This test requires the connection of sequentially numbered circles (A), and the connection of circles marked by numbers and letters in alternating sequence (B). This test is considered a benchmark of executive function. The test score is the time required to complete the task in seconds.|Baseline-12 months||||seconds||Standard Error|Least Squares Mean
1237345|NCT00605033|Primary|Response Rate|Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.|Assessed by Day 7 of double-blind, double-dummy treatment period.|Analysis of primary outcome was done on the intention-to-treat (ITT) population, defined as all randomized subjects who took at least one dose of study medication and provided at least one valid post-baseline assessment.|||Percentage of participants|||Number
1237346|NCT00604968|Secondary|Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment|The cumulative sum of hospitalization days during the study, per patient. Some patients had multiple hospitalizations.|Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).|Of the 25 total patients, 12 were hospitalized during the study.|||days|||Number
1237347|NCT00604968|Secondary|Duration of Overall Survival|Patients were followed with regards to survival even after they left the trial (ie after End of Treatment visit). Deaths that occurred after patient participation ended were collected all the way through to the overall end of the trial which took place on Oct 31, 2009. These deaths were used to calculate overall survival.|Time of treatment until death, up to the time that all participants ended treatment||||months||95% Confidence Interval|Median
1237348|NCT00604968|Secondary|Time to Progression|"Progression is defined as the first evaluation that shows progression (either by RECIST or WHO criteria):~Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease.~Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions."|Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Of the 25 patients in the study 3 patients had non-measurable disease and could not be included in the progression analysis.|||months||95% Confidence Interval|Median
1237349|NCT00604968|Secondary|Duration of Response|"Duration of response is defined as the time span from the first evaluation that shows response until the first evaluation that shows progression. Where patients did not show progress, duration of response was measured from the first evaluation that showed response until they discontinued the study.~Response can be partial or complete (as previously defined), whichever status is recorded first."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Three patients showed Partial Response according to RECIST criteria.|||weeks||Full Range|Median
1237350|NCT00604968|Secondary|Time to Response|Response can be partial (>=30% decrease in the sum of Longest Diameter of target lesions, determined by two observations not less than 4 weeks apart; no unequivocal increase in the size of non-target lesions or the appearance of new lesions may occur) or complete (disappearance of all clinical evidence of tumor determined by 2 observations not less than 4 weeks apart), whichever status is recorded first.|Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Only 3 patients had measureable time to response|||Weeks||Full Range|Median
1237351|NCT00604968|Secondary|Number of Patients Requiring Dose Reduction|The protocol contains instructions to reduce the Caelyx dose according to specific schedules, in cases necessary due to reasons such as hematological toxicity, non-hematological toxicity, cardiotoxicity, or other toxic side-effects of treatment reducing quality of life etc.|Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).||||participants|||Number
1237352|NCT00604968|Secondary|Number of Patients With Progressive Disease (PD) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST PD criteria required >=20% increase in certain target lesions OR progression of non-target lesions, or appearance of new lesions~WHO PD criteria required increase in size of existing lesions or appearance of new lesions."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.|||participants|||Number
1237353|NCT00604968|Secondary|Number of Patients With Partial Response (PR) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST PR criteria required >=30% decrease in certain target lesions & no increase in size of non-target lesions or appearance of new lesions~WHO PR criteria required partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for >=4 wks"|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.|||participants|||Number
1237354|NCT00604968|Secondary|Number of Patients With Stable Disease (SD) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST response criteria for SD required steady state of response of at least 9 weeks duration. There may be no appearance of new lesions.~WHO response criteria for SD required no significant change for at least 8 weeks."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.|||participants|||Number
1237355|NCT00604968|Primary|Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).|Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.|Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).||||Months||95% Confidence Interval|Median
1237379|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at Week 12|Clinical chemistry parameters included ALT, ALP and AST. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Units per Liter||Standard Deviation|Mean
1237356|NCT00604825|Secondary|Change From Baseline at Week 12 in Abdomen Visceral Adipose Tissue (AVAT), Abdomen Subcutaneous Adipose Tissue (ASAT), Thigh Subcutaneous Adipose Tissue (TSAT) and Thigh Intermuscular Adipose Tissue (TIAT)|AVAT, ASAT, TSAT and TIAT was measured in centimeter to once decimal place by CT scan. A CT scan of the abdomen was conducted at the Lumbar 4 vertebrae level. A CT scan of the right thigh was performed at half the distance between the knee joint and greater trochanter femoralis. Scans were performed with 120 kilovolts, 5 millimeter slice thickness (thigh scan 3 millimeter slice thickness) and 48 centimeter scan field of view. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Body Composition Population. Only those participants available at the specified time points were analyzed.|||Square centimeters||Standard Deviation|Mean
1237357|NCT00604825|Secondary|Change From Baseline at Week 12 in Abdomen Body Circumference, Abdomen Saggital Diameter and Thigh Circumference|Thigh circumference was measured on the left leg directly below the gluteal fold; with the participant standing with both arms at the side, feet together, and with equal weight on both feet when this measurement was taken. The thigh was measured at least twice until two measurements were within 1 centimeter, and the last reading recorded. Abdomen body circumference and abdomen saggital diameter was measured in centimeter to once decimal place by Computerized tomography (CT) scan with the participant in supine position. CT scan of the abdomen was conducted at the Lumbar 4 vertebrae level. Scans were performed with 120 kilovolts, 5 millimeter slice thickness and 48 centimeter scan field of view. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Body Composition Population which comprised of any ITT participants who provided consent for the body composition sub-study and received additional body composition assessments. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Deviation|Mean
1237358|NCT00604825|Secondary|Change From Baseline at Week 12 in Body Mass Index (BMI)|BMI was calculated from height (taken at Screening Visit 1 [Day -35]) and weight at Week 12 using the formula: BMI = [weight in kilograms divided by (height in meters)^2]. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Kilogram per square meters||Standard Error|Least Squares Mean
1237359|NCT00604825|Secondary|Change From Baseline at Week 12 in Weight|Participants were weighed on a calibrated balance beam or digital scale. Participants were instructed to be dressed in light indoor clothing without shoes and also to have empty pockets and to void before weighing. It was strongly recommended that participants were weighed in the morning at the beginning of the clinic visit. Weight was measured at least twice or more if necessary, until two measurements were within 0.5 kilograms. The last (confirmed) reading was recorded in the electronic case report form. Weight was recorded in kilograms to the nearest tenth. When the weight was measured in pounds, it was converted into kilograms using the conversion factor: pounds/ 2.2 = kilograms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Kilograms||Standard Error|Least Squares Mean
1237360|NCT00604825|Secondary|Change From Baseline at Week 12 in Hip Circumference|For hip circumference, the participant was instructed to stand erect with arms at sides and feet together. The measurement was taken at the point yielding the maximum circumference over the buttocks (widest part of the greater trochanters) with nonstretchable tape. The tape was even, not twisted with the measurement scale facing outward. The assessor was instructed to ensure that the tape was just touching the skin but not compressing the soft tissue. The hip should be measured at least twice until two measurements are within 1 centimeter and the last reading recorded. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Error|Least Squares Mean
1237361|NCT00604825|Secondary|Change From Baseline at Week 12 in Waist Circumference|To measure waist circumference, clothing was lifted from around the waist to ensure correct positioning of the measuring tape. Participants were instructed to stand erect with abdomen relaxed, arms at side, feet together, and weight equally divided over both legs. The non-stretchable tape was placed at the waist midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. The tape was even, parallel to the floor not twisted with the measurement scale facing outward. The assessor was instructed to ensure that the tape was just touching the skin but not compressing the soft tissue. The measurement was made at the end of a normal expiration. The waist was measured at least twice or more if necessary, until two measurements were within 1 centimeter and the confirmatory reading recorded to one decimal place. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Error|Least Squares Mean
1237362|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Testosterone|Serum hormones included testosterone. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline at Week 12 in testosterone are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Nanomol per Liter||Standard Deviation|Mean
1237363|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Serum hormones included FSH and LH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||International units per Liter||Standard Deviation|Mean
1237364|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Estradiol|Serum hormone included Estradiol. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline at Week 12 in estradiol are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Picomoles per Liter||Standard Deviation|Mean
1238784|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Musculoskeletal’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1237366|NCT00604825|Secondary|Change From Visit 2 to Visit 8 in Percentage of Superficial Cells to Determine the Vaginal Maturation Index (VMI)|"A lateral vaginal wall specimen was collected at Visit 2 (Day -21) and Visit 8 (Week 12) and was sent to Central Pathology for analysis. Parabasal, intermediate, and superficial squamous cells were counted and percentages calculated. The VMI (also referred to as Maturation Value [MV]) of the vaginal mucosa was calculated according to the following equation:~VMI (MV)= (% Intermediate Cells x 0.5) + (% Superficial cells). Visit 2 was Day -21 and Visit 8 was Week 12. Change from Visit 2 to Visit 8 was calculated by subtracting Visit 2 values from Visit 8 values."|Visit 2 (Day -21) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of cells||Standard Error|Least Squares Mean
1237367|NCT00604825|Secondary|Change From Visit 2 to Visit 8 in Vaginal pH|Vaginal pH was measured at Visit 2 and Visit 8 using standard pH indicator strips available at the participating site clinic. The pH indicator strip was inserted to the upper portion of the proximal one third of the vaginal vault, placed in contact with the lateral vaginal mucosal wall for approximately 1 minute, and evaluated according to the instructions provided in the package labeling. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the vagina and higher the number, more alkaline the vagina with 7 being neutral. Change from Visit 2 to Visit 8 was calculated by subtracting Visit 2 values from Visit 8 values.|Visit 2 (Day -21) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.|||Points on a scale||Standard Error|Least Squares Mean
1237368|NCT00604825|Secondary|Change in Work Productivity and Activity Impairment (WPAI) Score From Visit 2 to Visit 7|The WPAI is a questionnaire that measured workplace productivity and absenteeism via 6 items/questions, adapted to participants experiencing menopausal symptoms. Item 1 asks about current employment with a yes/no response. Items 2– 4 ask for continuous response in hours. Item 5 asks for response on rating scale related to WP ranging from 0:Menopausal symptoms had no effect on work to 10:Couldn’t work at all. Item 6 asks for response on rating scale related to daily activities ranging from 0:no effect on daily activities to 10:Couldn’t perform any daily activities. The score calculation- Effect on work: (Item 5 score÷10); Absenteeism: (Item 2÷Item 2+Item 4); Overall work impairment ([Item 2÷Item 2+Item 4]+ [1- {Item 2÷Item 2+Item 4}]*[ Item 5 score÷10]); Activity impairment: (Item 6 score÷10). Total score range from 0 to 10 where higher score indicates worst condition. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1237369|NCT00604825|Secondary|Change in the Centers for Epidemiologic Studies in Depression (CES-D) Score From Visit 2 to Visit 7|The CES-D is a questionnaire designed to measure depressive symptoms via 20 items that are summed to create a total score. Depressive symptoms are fairly common in postmenopausal women, and it’s possible that stimulation of estrogen receptors via a selective estrogen receptor modulator may improve depressive symptoms. Questions 4, 8, 12 and 16 are weighted negatively (the scores are flipped prior to creating total score). If 3 or more items are missing then total score is missing. If fewer than 3 items are missing then missing item is set to group mean of that item for appropriate randomized treatment group. These means are only calculated if more than half of the participants used for calculation have responded to item. The items are summed to give total score ranging from 0 to 60. Lower score 0=no depression, higher score 60=higher degree of depression severity. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1237370|NCT00604825|Secondary|Change in Brief Fatigue Inventory (BFI) Score From Visit 2 to Visit 7|The BFI is a validated questionnaire designed to measure a participant’s fatigue via nine questions that are summated to create a total score. Items 1-3 request a rating on a scale ranging from 0 – 10 with 0 representing ‘No Fatigue’ and 10 representing ‘As bad as you can imagine’. Five items 4A-4F request an interference score on a scale ranging from 0 – 10 with 0 representing ‘Does not interfere’ and 10 representing ‘Completely Interferes’. The values of the scales for all items was used in scoring the response to each item. The following groupings of items was used to create domain scores. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher score indicates more severe fatigue. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1237371|NCT00604825|Secondary|Changes in Vulvar Vaginal Atrophy (VVA) Symptom Score From Baseline to Visit 8 (Week 12)|The VVA Symptoms Scale questionnaire is an 18-item instrument that captures symptoms related to VVA, asks participant to identify symptom that bothers them the most and contains items to assess degree of bother participants experience from each symptom and impact that most bothersome symptom has on their daily life. Items 1 to 8 had responses and scores of none=0, mild=1, moderate=2 and severe=3. Items 9 to 18 had responses and scores of not at all=0, a little=1, moderately=2 and a lot=3. Severity item and bothersome item respectively were as follows: vaginal dryness:1 and 9; Vaginal itching:2 and 10; Vaginal irritation:3 and 11; Painful urination:4 and 12; Difficulty urinating:5 and 13; Vaginal pain associated with sexual activity:6 and 14; Vaginal bleeding associated with sexual activity:7 and 15. Total score ranged from 0 to 3; higher score indicated most bothersome. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
1237380|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Creatinine, Direct Bilirubin, Total Bilirubin and Uric Acid at Week 12|Clinical chemistry parameters included creatinine, direct bilirubin, total bilirubin and uric acid. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Micromoles per Liter||Standard Deviation|Mean
1237422|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding||Through 30days following PPCI|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)|||participants|||Number
1237372|NCT00604825|Secondary|Change in Medical Outcomes Study (MOS) Sleep Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)|The MOS Sleep Scale is a validated questionnaire designed to measure a participant sleep quality via 12 questions. Items are designed to be grouped into domains that include sleep disturbance (items 1, 3, 7, 8), sleep adequacy (items 4, 12), daytime somnolence (items 6, 9, 11), sleep quantity (2), 6-Item Sleep Scale (items 4, 5, 7, 8, 9, 12) and 9-Item Sleep Scale (items 3, 4, 5, 6, 7, 8, 9, 11, 12). Each domain is given a separate score. The domain score is calculated as the sum of the individual item scores in that domain. Transformed scores were calculated for the domains only. This transformation converts the raw domain score to a 0 to 100 scale following the formula: Transformed score = ([Raw score – Lowest possible score]/Possible score range)*100. Lowest score 0 indicates best sleep quality and higher score 100 indicates worst sleep quality. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1237373|NCT00604825|Secondary|Change in Menopause Quality of Life (MENQoL) Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)|MENQOL instrument is a 32-item, validated questionnaire designed to measure symptoms that participants experience due to menopause and degree to which these symptoms bother them. Each item references a symptom and is composed of two-part question; a yes/no confirmation that the participant has symptom followed by a question asking how bothersome the symptom is, if present. The MENQOL items are designed to be grouped into domains that address vasomotor (items 1-3), psychosocial(items 4-10), physical (items 11-26, 30-32) and sexual symptoms (items 27-29). Each domain is given a separate score; there is no overall score. The domain score is sum of individual item scores divided by number of items in that domain. Since domain subscales are not comprised of an equivalent number of items, mean of subscale is used as overall subscale score. Each domain score ranges from 1 to 8. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1237374|NCT00604825|Secondary|Number of Participants With VMS Percent Change From Baseline Responders With a Reduction in Severity at Week 12 of at Least 50%, at Least 75%, and 100%|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. The VMS severity was as follows: mild (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate (heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe (intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). The severity of VMS events were calculated using self-reported participants assessments recorded and transmitted by eDiary. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent change was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1237375|NCT00604825|Secondary|Number of Participants With VMS Percent Change From Baseline Responders With a Reduction in Frequency at Week 12 of at Least 50%, at Least 75%, and 100%|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change question. The severity of VMS events were calculated using self-reported participants assessments recorded and transmitted by eDiary. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent change was calculated by multiplying the change from baseline value with 100. Number of participants with VMS percent change from Baseline responders with a reduction in frequency at Week 12 of at least 50%, at least 75%, and 100% are presented.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1237376|NCT00604825|Secondary|Mean Change in Severity of VMS From Baseline to Weeks 4 and 8|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. The VMS severity was as follows: mild=score of 1 (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate=score of 2(heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe=score of 3(intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe=score of 4 (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). Total score ranged from 1 to 4 and is the sum of severity scores divided by total number of VMS events. Higher score indicates worst condition. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 8|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1237377|NCT00604825|Secondary|Mean Change in Frequency of VMS From Baseline to Weeks 4 and 8|"Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using as Global Change Question. The frequency was assessed using the question 1 as Since you started the study medication, how has the number of your hot flashes (including night sweats) changed?. the response was rated on a 7-point scale from +3 to -3, where +3=A great deal better, +2=Moderately better, +1=A little better, 0=No change, -1=A little worse, -2=Moderately worse and -3=A great deal worse. The score ranged from +3 to -3, where +3 implied absence of symptoms and lower score implied more severe symptoms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values."|Baseline (Week 0) to Week 8|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1237378|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (C02) Content, Chloride, Phosphorous, Inorganic, Potassium, Sodium and Urea at Week 12|Clinical chemistry parameters included calcium, C02 content, chloride, phosphorous, inorganic, potassium, sodium and urea. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimol per Liter||Standard Deviation|Mean
1237382|NCT00604825|Primary|Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils and White Blood Cell (WBC) Count at Week 12|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils and WBC count. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline and Week 12 in basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils and WBC count are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Gigacells per Liter||Standard Deviation|Mean
1237383|NCT00604825|Primary|Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Week 12|Hematology parameters included Hemoglobin and MCHC. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram per Liter||Standard Deviation|Mean
1237384|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Red Blood Cell (RBC) Count at Week 12|Hematology parameter included RBC count. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Trillion cells per Liter||Standard Deviation|Mean
1237385|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Mean Corpuscle Volume (MCV) at Week 12|Hematology parameter included MCV. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Femtoliters||Standard Deviation|Mean
1237386|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Mean Corpuscle Hemoglobin (MCH) at Week 12|Hematology parameter included MCH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
1237387|NCT00604825|Primary|Change From Baseline and Week 12 in Hematology Parameter- Hematocrit at Week 12|Hematology parameter included hematocrit. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
1237388|NCT00604825|Primary|Change From Baseline and Week 12 in Inflammatory Marker- Endothelin-1 at Week 12|Inflammatory marker included Endothelin-1. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Nanogram per Liter||Standard Deviation|Mean
1237389|NCT00604825|Primary|Change From Baseline and Week 12 in Inflammatory Marker- High Sensitivity C-reactive Protein (Hs-CRP) at Week 12|Inflammatory marker included hs-CRP. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Milligram per Liter||Standard Deviation|Mean
1237390|NCT00604825|Primary|Change From Baseline in Thrombotic Marker- Tissue Plasminogen Activator (tPA) Antigen at Week 12|Thrombotic marker included tPA antigen. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Microgram per Liter||Standard Deviation|Mean
1237391|NCT00604825|Primary|Change From Baseline in Thrombotic Marker- Fibrinogen at Week 12|Thrombotic marker included fibrinogen. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram per LIter||Standard Deviation|Mean
1237392|NCT00604825|Primary|Mean Change in Severity of VMS From Baseline at Week 12|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. VMS severity was as follows: mild=score of 1 (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate=score of 2(heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe=score of 3(intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe=score of 4 (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). Total score ranged from 1 to 4 and is the sum of severity scores divided by total number of VMS events. Higher score indicates worst condition. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1237393|NCT00604825|Primary|Mean Change in Frequency of Vasomotor Symptoms (VMS) From Baseline at Week 12|"Individual VMS (hot flash or night sweats) events were recorded by participants in an electronic diary (eDiary) using as Global Change Question. The frequency was assessed using the question 1 as Since you started the study medication, how has the number of your hot flashes (including night sweats) changed?. the response was rated on a 7-point scale from +3 to -3, where +3=A great deal better, +2=Moderately better, +1=A little better, 0=No change, -1=A little worse, -2=Moderately worse and -3=A great deal worse. The score ranged from +3 to -3, where +3 implied absence of symptoms and lower score implied more severe symptoms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Adjusted mean is presented as least square mean."|Baseline (Week 0) and Week 12|Intent-to-Treat Population (ITT) Population which comprised of all randomized participants. Last Observation Carried Forward (LOCF) was the imputation technique used.|||Scores on a Scale||Standard Error|Least Squares Mean
1237736|NCT00603239|Secondary|Percentage of Patients Achieving HbA1c <= 6.5%|Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||percentage of participants|||Number
1237394|NCT00604825|Primary|Occurrence of Withdrawal Bleeding-number of Days of Spotting, Number of Days of Bleeding, Number of Days of Spotting/Bleeding Combined|After completion of the 12-week treatment period, participants with an intact uterus received a 14-day cycle of progestogen (10 mg MPA) to induce withdrawal bleeding. All participants were required to return to clinic for Follow-Up Visit. Participants were asked to record occurrence of bleeding/spotting each day, from the day MPA dosing began until Follow-up using the following criteria: None (no bleeding or spotting), Spotting: any vaginal flow requiring not more than one sanitary napkin or tampon per day (lightly stained and not soaked through) and Bleeding: any vaginal flow requiring more than one sanitary napkin or tampon per day. The following information was recorded in electronic case report form: start and stop date of MPA administration as well as dates of any spotting/bleeding. Duration of spotting, bleeding and also spotting/bleeding combined is presented.|Up to Follow-up (Day 112)|Uterine Safety Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
1237395|NCT00604825|Primary|Occurrence of Withdrawal Bleeding-duration of Spotting/Bleeding|After completion of the 12-week treatment period, participants with an intact uterus received a 14-day cycle of progestogen (10 mg medroxyprogesterone acetate [MPA]) to induce withdrawal bleeding. All participants were required to return to clinic for Follow-Up Visit. Participants were asked to record occurrence of bleeding/spotting each day, from the day MPA dosing began until Follow-up using the following criteria: None (no bleeding or spotting), Spotting: any vaginal flow requiring not more than one sanitary napkin or tampon per day (lightly stained and not soaked through) and Bleeding: any vaginal flow requiring more than one sanitary napkin or tampon per day. The following information was recorded in electronic case report form: start and stop date of MPA administration as well as dates of any spotting/bleeding. Duration of spotting or bleeding is presented.|Up to Follow-up (Day 112)|Uterine Safety Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
1237396|NCT00604825|Primary|Endometrial Biopsy Pathology|Endometrial biopsies were conducted at Baseline and end-of-treatment (end-of-treatment values were defined as the last available post-Baseline values before treatment was stopped) for all study participants with an intact uterus. These procedures were performed by an experienced physician. Each biopsy was obtained after the TVUS was performed. Proliferative endometrium also meant hyperplasia without atypia (normal).|Baseline (Week 0) to Week 12|Uterine safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1237397|NCT00604825|Primary|Change From Baseline in Bi-layer Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS) or Saline Infusion Sonohysterography (SIS)|All participants with an intact uterus participating in this study underwent a TVUS at Baseline and at Week 12, to investigate the cause of any abnormal uterine bleeding during the study. In the event the TVUS was not well visualized or there were abnormal findings at either visit, or the bi-layer thickness exceeded 5 millimeter at Week 12, a SIS was conducted to visualize the anterior and posterior walls. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline and Week 12 in heart rate are presented.|Baseline (Week 0) to Week 12|Uterine Safety Population which comprised of all randomized participants who had a uterus and also received at least one dose of investigational product. Only those participants available at the specified time points were analyzed.|||Millimeter||Standard Deviation|Mean
1237398|NCT00604825|Primary|Change From Baseline in Fasting Lipid Profile at Week 12|Fasting lipids included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholestereol direct and triglycerides. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in fasting lipid profile at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimole per Liter||Standard Deviation|Mean
1237399|NCT00604825|Primary|Change From Baseline in Thyroxine (T4) and Insulin at Week 12|Serum hormone markers included T4 and additional pharmacodynamics marker included insulin. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in T4 and insulin at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Picomole per Liter||Standard Deviation|Mean
1237400|NCT00604825|Primary|Change From Baseline in Thyroid Stimulating Hormone (TSH) at Week 12|Serum hormone markers included TSH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in TSH at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Milliunits/Liter||Standard Deviation|Mean
1237401|NCT00604825|Primary|Change From Baseline in Vital Sign of Heart Rate at Week 12|Heart rate was measured after the participant had rested for at least 5 minutes in a sitting or supine position. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in heart rate at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1237402|NCT00604825|Primary|Change From Baseline in Vital Signs of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12|SBP and DBP were measured after the participant had rested for at least 5 minutes in a sitting or supine position. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in SBP and DBP at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1237423|NCT00604695|Secondary|Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14|Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients|||participants|||Number
1237814|NCT00602225|Primary|Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0||45 days after the last dose of clofarabine||||Participants|||Count of Participants
1237403|NCT00604825|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) and Number of Participants With Mild, Moderate and Severe AE|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. The severity of AEs was assessed by the investigator as mild, moderate or severe.|Up to 21 weeks|Safety Population which comprised of all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
1237404|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Apparent Half-life (Apparent t½)|Preliminary pharmacokinetics data; Apparent half-life (t½)|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.|||Hours||Standard Deviation|Mean
1237405|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax)|Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.|||Hours||Full Range|Median
1237406|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Maximum Concentration (Cmax)|Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.|||ng/mL||Standard Deviation|Mean
1237407|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))|Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.|||ng hr/mL||Standard Deviation|Mean
1237408|NCT00604812|Primary|Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)|24 Hours|All Subjects as Treated- All subjects who received at least one dose of the investigational drug was used for assessments of safety and tolerability.|||Participants|||Number
1237409|NCT00604786|Primary|Change in Basophil Surface IgE|"Flow cytometry in mean fluorescence units.~100%*[(3.5 month value minus baseline value)/baseline value]"|Change from baseline to 3.5 months|2 participants on the Omalizumab subcutaneous group moved and were therefore lost to follow-up.|||percentage of basophil surface IgE||Standard Deviation|Mean
1237410|NCT00604721|Secondary|Median Overall Survival (OS)|Overall survival has been defined as time from the start of treatment to death as a result of any cause.|33 weeks|Participants who completed a full 21 day cycle of therapy|||months||95% Confidence Interval|Median
1237411|NCT00604721|Secondary|Median Progression Free Survival (PFS)|Progression free survival has been defined as time from the start of treatment to disease progression or death as a result of any cause.|33 weeks|Participants who completed a full 21 day cycle of therapy|||months||95% Confidence Interval|Median
1237412|NCT00604721|Primary|Number of Participants With Radiographic Objective Response (OR)|"To ascertain the objective response rate (Complete Response + Partial Response [CR+PR]) of patients with the single-agent AZD6244. Our study utilized Response Evaluation Criteria in Solid Tumors (RECIST) to evaluate response.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|33 weeks|Participants who completed a full 21 day cycle of therapy|||participants|||Number
1237413|NCT00604708|Primary|GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56|GMT: geometric mean of PRNT50|Day 56|PP Population: All randomized subjects without any major protocol deviations as assessed during a Data Review Meeting. Subjects who were randomized incorrectly or took the wrong study medications were also excluded.|||titers||Standard Deviation|Geometric Mean
1237414|NCT00604708|Secondary|Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age||Day 56|||||||
1237415|NCT00604708|Secondary|Immunogenicity at Day 56 for North America vs. Europe||Day 56|||||||
1237416|NCT00604708|Secondary|Immunogenicity at Day 28||Day 28|||||||
1237417|NCT00604708|Secondary|Safety and Adverse Events||until Day 56|||||||
1237418|NCT00604708|Primary|SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56|SCR: anti-JEV neutralizing antibody titer ≥1:10|Day 56|Per Protocol Population: all randomized subjects without any protocol deviations as defined in the Statistical Analysis Plan|||percentage of participants|||Number
1237419|NCT00604695|Secondary|Safety Endpoint: Number of Deaths||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)|||participants|||Number
1237424|NCT00604695|Secondary|Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)|Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients|||Corrected TIMI Frame Count (cTFC)||Inter-Quartile Range|Median
1237425|NCT00604695|Secondary|Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."|||participants|||Number
1237426|NCT00604695|Secondary|Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention||Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."|||participants|||Number
1237427|NCT00604695|Primary|Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention||Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."|||Percent diameter stenosis||Inter-Quartile Range|Median
1237428|NCT00604669|Primary|Mortality|Mortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06.|at the end of the chart review of all patients||||mortality rate|||Number
1237429|NCT00604565|Primary|TOTAL NUMBER OF ADVERSE EVENTS|Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.|36 weeks|All subjects were included in the Safety Analysis population.|||events|||Number
1237430|NCT00604565|Primary|TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS|Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.|36 weeks|All subjects were included in the Safety Analysis population.|||participants|||Number
1237431|NCT00604552|Secondary|Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events||5 years|Study terminated before subjects met study 5 year endpoints. FDA agreed to closure of study prior to reaching the 5 year endpoint.||||||
1237432|NCT00604552|Primary|Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion|Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion|5 year|All those treated on-label for the treatment of an AAA and followed out to 5 years.|||participants|||Number
1237433|NCT00604500|Primary|End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)|The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.|4-week Treatment Period|Completer Population, excluding 2 participants who used more than the labeled number of actuations.|||Number of inhalers|||Number
1237434|NCT00604500|Primary|Overall Discrepancy Size|Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.|4-week Treatment Period|Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.|||Discrepancy Size Per 100 actuations|||Number
1237435|NCT00604500|Primary|Overall Quartile Discrepancy Rate|"Quartile discrepancies refer to the difference between~the participant-recorded number of actuations and the participant-recorded~counter readout at each of the 4 weekly visit intervals [ie, quartiles] to~evaluate whether there was any difference in agreement over the life of~the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population."|4-week Treatment Period|Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.|||discrepancies per 100 actuations|||Number
1237463|NCT00604188|Secondary|Compliance Rate|Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment.|28 days|ITT population|||Percentage of days||Standard Deviation|Mean
1237436|NCT00604500|Primary|Overall Discrepancy Rate|Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).|4-week Treatment Period|Completer population, defined as participants who recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.|||Overall discrepancies per 100 actuations|||Number
1237437|NCT00604461|Secondary|Number of Months of Progression Free Survival (PFS)|The PFS is defined as the duration of time from the start of treatment to time of progression or death, whichever occurs first.|2 Years, 9 Months|All participants|||Months||95% Confidence Interval|Median
1237438|NCT00604461|Primary|Number of Participants With Partial Response (PR) of Target Lesions|Tumor response was assessed in 12 patients who had at least one follow-up computed tomography (CT) scan. Response Evaluation Criteria in Solid Tumors (RECIST) definition of Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 12 Months|All participants with baseline and at least one post-baseline target lesion measurement.|||participants|||Number
1237439|NCT00604383|Secondary|Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire|SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health.|Baseline, up to 36 months|All randomized participants with evaluable SF-36 MCS and PCS. LOCF was used to impute missing post-baseline values|||units on a scale||Standard Deviation|Mean
1237440|NCT00604383|Secondary|Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)|NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome).|Baseline, up to 36 months|All randomized participants with evaluable NEI-VFQ-25 total score. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1237441|NCT00604383|Secondary|Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)|Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100.|Baseline through 36 months|All randomized participants.|||percentage of participants|||Number
1237442|NCT00604383|Secondary|Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)|DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) * 100.|Baseline through 36 months|All randomized participants who had no center involved or imminently threatened DME at baseline.|||percentage of participants|||Number
1237443|NCT00604383|Primary|Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period|SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) * 100.|Baseline through 36 months|All randomized participants.|||percentage of participants|||Number
1237444|NCT00604279|Secondary|Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal|A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.|Day 92 or early withdrawal|Per Protocol Analysis Set.|||Percentage of participants|||Number
1237445|NCT00604279|Secondary|Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal|The self-administered sleep VAS scale (0-100 millimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).|Baseline, Day 92 or early withdrawal|Per Protocol Analysis Set.|||millimeter (mm)||Standard Deviation|Mean
1237446|NCT00604279|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening."|Baseline, Day 92 or early withdrawal|"Per Protocol Analysis Set. Here N (Number of Participants Analyzed) represents number of participants who were evaluable for this measure."|||Units on scale||Standard Deviation|Mean
1237447|NCT00604279|Secondary|Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal|This PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; <= 30, functioning so poorly as to require intensive supervision.|Baseline, Day 92 or early withdrawal|"Per Protocol Analysis Set. Here N (Number of Participants Analyzed) represents number of participants who were evaluable for this measure."|||Units on scale||Standard Deviation|Mean
1237448|NCT00604279|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.|Baseline, Day 92 or early withdrawal|Per Protocol Analysis Set included participants who received at least 2 injections of study medication had minimum 5 weeks of exposure to study treatment; had baseline and at least 1 post randomization measurement for primary efficacy variable and who did not have major protocol violations.|||Units on scale||Standard Deviation|Mean
1237449|NCT00604214|Secondary|Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint||Baseline through Day 28|Participants who received study drug.|||percentage of participants|||Number
1237450|NCT00604214|Other Pre-specified|Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28|Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days.|Baseline through Day 28|Participants who received study drug.|||percentage of participants|||Number
1237451|NCT00604214|Secondary|Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180|SF-12 was used as an instrument to measure participants’ physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing.|Baseline and Days 28 and 90 and 180|All randomized participants with SF-12 score data at the specified time points.|||units on a scale||Standard Deviation|Median
1237452|NCT00604214|Secondary|EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180|The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life).|Baseline and Days 28 and 90 and 180|All randomized participants with EQ-5D total score data at the specified time points.|||units on a scale||Standard Deviation|Mean
1237453|NCT00604214|Secondary|EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180|EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state.|Baseline and Days 28 and 90 and 180|All randomized participants with EQ-5D VAS data at the specified time points.|||units on a scale||Standard Deviation|Mean
1237454|NCT00604214|Secondary|Median Survival Time||Day 180|All randomized participants excluding those with unknown mortality status at Day 180.|||days||Full Range|Median
1237455|NCT00604214|Secondary|180-Day Mortality|Expressed as percentage of participants who died from any cause at Day 180 endpoint.|Day 180|All randomized participants with known mortality status at Day 180.|||percentage of participants|||Number
1237456|NCT00604214|Secondary|90-Day Mortality|Expressed as percentage of participants who died from any cause at Day 90 endpoint.|Day 90|All randomized participants with known mortality status at Day 90.|||percentage of participants|||Number
1237457|NCT00604214|Secondary|Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|||units on a scale||Standard Deviation|Mean
1237458|NCT00604214|Secondary|Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|||units on a scale||Standard Deviation|Mean
1237459|NCT00604214|Secondary|Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|||units on a scale||Standard Deviation|Mean
1237460|NCT00604214|Secondary|28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency|Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%).|Day 28|All randomized participants with severe protein C deficiency at Baseline with known mortality status at Day 28.|||percentage of participants|||Number
1237461|NCT00604214|Primary|28-Day All-Cause Mortality|Expressed as percentage of participants who died from any cause at Day 28 endpoint.|Day 28|All randomized participants with known mortality status at Day 28.|||percentage of participants|||Number
1237462|NCT00604188|Secondary|Responders at Day 28|Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued.|28 days|ITT population|||Participants|||Number
1237464|NCT00604188|Secondary|Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric|"The ASI-Lite is a standardized, multidimensional, semi-structured, comprehensive interview that estimates addiction-related problem severity profiles in seven domains commonly affected in substance abusers. ASI-lite composite score ranges from 0 (worst outcome) to 1 (best outcome) for each category. Reported here is the change in ASI-Lite from baseline to Day 28.~The original drug use accounts for heroin, methadone, other opiates, analgesics, medicine/pills, cocaine, amphetamines, cannabis, hallucinogens, and inhalants. Modified drug use accounts for heroin, methadone, cocaine, and cannabis."|Baseline and 28 days|ITT population.|||Score on a scale||Standard Error|Least Squares Mean
1237465|NCT00604188|Secondary|Observer-rated Opioid Withdrawal Symptoms (OOWS)|The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28.|Baseline and 28 days|Participants with OOWS data reviewed for completeness and within visit date consistency were analyzed.|||Score on a scale||Standard Deviation|Mean
1237466|NCT00604188|Secondary|Self-reported Opioid Withdrawal Symptoms (SOWS)|SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28.|Baseline and 28 days|Participants with SOWS data reviewed for completeness and within visit date consistency were analyzed.|||Score on a scale||Standard Deviation|Mean
1237467|NCT00604188|Secondary|Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)|Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use.|Days 3 to 28|ITT population|||Participants|||Number
1237468|NCT00604188|Secondary|Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)|Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28.|28 days|Participants with missing data were not included in the analysis.|||Participants|||Number
1237469|NCT00604188|Primary|Responders at Day 3|"Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders.~All participants that continued the study received Suboxone tablets on Day 3."|3 days|ITT population|||Participants|||Number
1237470|NCT00604175|Secondary|Change in CD4 Cell Count From Baseline|A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline.|Weeks 0, 4, 8, 12, 24, 28, 52 and 72|N=315 eligible participants who initiated intervention and had data available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=122; 92; 88. Week 8: n=119; 92; 90. Week 12: n=115; 87; 90. Week 24: n=117; 85; 88. Week 28: n=114; 89; 87. Week 52: n=108; 85; 87. Week 72: 105; 85; 88.|||Cells/mm^3||Inter-Quartile Range|Median
1237471|NCT00604175|Secondary|Change in Log10 HIV Viral Load (VL) From Baseline|A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline.|Weeks 0, 4, 12, 28, 52, and 72|N=315 eligible participants who initiated intervention and had HIV VL available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=123; 89; 88. Week 12: n=118; 89; 90. Week 28: n=118; 91; 87. Week 52: n=109; 85; 82. Week 72: n=105; 81; 83.|||Log10 copies/mL||Inter-Quartile Range|Median
1237472|NCT00604175|Secondary|Number of Participants With Laboratory Abnormalities of Grade 3 or Higher|Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From baseline to up to Week 72|All eligible participants who received at least one vaccine.|||Participants|||Number
1237473|NCT00604175|Secondary|Number of Participants With Signs and Symptoms of Grade 3 or Higher|Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From baseline to up to Week 72|All eligible participants who received at least one vaccine.|||Participants|||Number
1237474|NCT00604175|Secondary|Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline|Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV18 at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=27; 11; 19. Week 72: n=25; 11; 19.|||Log10 mMU/mL||Inter-Quartile Range|Median
1237483|NCT00604175|Primary|Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers <20 mMU/mL) at baseline to seropositive (HPV16 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV16 at baseline who completed the vaccination series per protocol and had HPV16 titer available at Week 28.|||Percentage of participants||95% Confidence Interval|Number
1237475|NCT00604175|Secondary|Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline|Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV16 (HPV16+) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=40; 28; 24. Week 72: n=37; 25; 24.|||Log10 mMU/mL||Inter-Quartile Range|Median
1237476|NCT00604175|Secondary|Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline|Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV11 (HPV11+) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=20; 21; 17. Week 72: n=17; 18; 19.|||Log10 mMU/mL||Inter-Quartile Range|Median
1237477|NCT00604175|Secondary|Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline|Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV6 (HPV6+) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=52; n=33; n=36. Week 72: n=43; 31; 35.|||Log10 mMU/mL||Inter-Quartile Range|Median
1237478|NCT00604175|Secondary|HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline|HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (<24 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV18 (HPV18-) at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=86; 80; 69. Week 72: n=75; 73; 69.|||mMU/mL||95% Confidence Interval|Geometric Mean
1237479|NCT00604175|Secondary|HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline|HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (<20 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV16 (HPV16-) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=73; 63; 64. Week 72: n=63; 59; 64.|||mMU/mL||95% Confidence Interval|Geometric Mean
1237480|NCT00604175|Secondary|HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline|HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (<16 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV11 (HPV11-) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=93; 70; 71. Week 72: n=83; 66; 69.|||mMU/mL||95% Confidence Interval|Geometric Mean
1237481|NCT00604175|Secondary|HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline|HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (<20 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV6 (HPV6-) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=60; 58; 52. Week 72: n=55; 53; 53.|||mMU/mL||95% Confidence Interval|Geometric Mean
1237482|NCT00604175|Primary|Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers <24 mMU/mL) at baseline to seropositive (HPV18 antibody titers >=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV18 at baseline who completed the vaccination series per protocol and had HPV18 titer available at Week 28.|||Percentage of participants||95% Confidence Interval|Number
1237513|NCT00603889|Secondary|100 Mcg/ml Na-ASP-2 Intradermal Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application||||units on a scale||Full Range|Mean
1237484|NCT00604175|Primary|Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers <16 mMU/mL) at baseline to seropositive (HPV11 antibody titers >=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV11 at baseline who completed the vaccination series per protocol and had HPV11 titer available at Week 28.|||Percentage of participants||95% Confidence Interval|Number
1237485|NCT00604175|Primary|Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers <20 mMU/mL) at baseline to seropositive (HPV6 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV6 at baseline who completed the vaccination series per protocol and had HPV6 titer available at Week 28.|||Percentage of participants||95% Confidence Interval|Number
1237486|NCT00604162|Primary|Specificity of Capsule Endoscopy for Indicated Lesions|Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.|1 day|Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.|||Percentage of Participants||95% Confidence Interval|Number
1237487|NCT00604162|Secondary|Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)||within 7 days|||||||
1237488|NCT00604162|Primary|Sensitivity of Capsule Endoscopy for Indicated Lesions|Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.|1 day|Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.|||Percentage of Participants||95% Confidence Interval|Number
1237489|NCT00604162|Primary|Number of Participants With Indicated Lesions Detected by Standard Colonoscopy|"Since the standard colonoscopy is the gold standard to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger."|1 day|Participants in the Accuracy Analysis successfully had both capsule endoscopy and colonoscopy.|||participants|||Number
1237490|NCT00604162|Secondary|Percentage of Excreted Colon Capsules||Within 7 days|||||||
1237491|NCT00604162|Secondary|Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy||within 7 days|||||||
1237492|NCT00604162|Secondary|Number, Type and Severity of Adverse Events||Within 7 days|||||||
1237493|NCT00604162|Secondary|Percent of Participants With Scoring Index 3 or 4|"Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:~poor cleansing level (Large amount of fecal residue.)~fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)~good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)~excellent cleansing level (No more than small bits of adherent feces.)"|1 day||||Percentage of Participants||95% Confidence Interval|Number
1237494|NCT00604162|Primary|Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies|The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.|1 day||||participants|||Number
1237495|NCT00604045|Primary|Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)|The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80, with higher scores indicating more severe symptoms.|Pre-Treatment, Post-Treatment (after 4 weeks of treatment)||||units on a scale||Standard Deviation|Mean
1237496|NCT00604019|Secondary|Safety, Arrythmia - Yes or no for Each Group||28 days|||||||
1237497|NCT00604019|Primary|Efficacy|Dead at 28 days|28 days||||participants|||Number
1237498|NCT00603993|Secondary|Duration (Minutes) of the Presence of Morning Stiffness by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.|||minutes||Standard Deviation|Mean
1237499|NCT00603993|Secondary|Presence of Morning Stiffness by Visit|The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.|||participants|||Number
1237500|NCT00603993|Secondary|Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit|Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)||||mg/dL||Standard Deviation|Mean
1237501|NCT00603993|Secondary|Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities [0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so]), a component of the ACR criteria by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)||||units on a scale||Standard Deviation|Mean
1237502|NCT00603993|Secondary|Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)||||mm on a scale||Standard Deviation|Mean
1237503|NCT00603993|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit|mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)||||mm on a scale||Standard Deviation|Mean
1237504|NCT00603993|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)||||mm on a scale||Standard Deviation|Mean
1237505|NCT00603993|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)||||SJC||Standard Deviation|Mean
1237506|NCT00603993|Secondary|Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)||||TJC||Standard Deviation|Mean
1237507|NCT00603993|Primary|Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)|Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|Analysis was based on observed data.|||participants|||Number
1237508|NCT00603915|Secondary|Number of Participants With the Responses Outlined|"Complete Response (CR): disappearance of all clinical and radiological evidence of tumour.~Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease."|Measured every 2 cycles until the participant is off treatment.||||Participants|||Number
1237509|NCT00603915|Primary|Progression Free Survival.|From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died.|From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.||||Months||95% Confidence Interval|Mean
1237510|NCT00603902|Secondary|Percent Change in Body Weight From Baseline to Week 52|The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF|||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
1237511|NCT00603902|Primary|Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.~Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF|||percentage of participants|||Number
1237512|NCT00603889|Secondary|1000 Mcg/ml Na-ASP-2 Intradermal Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application||||units on a scale||Full Range|Mean
1237514|NCT00603889|Secondary|1000 Mcg/ml Na-ASP-2 Prick-puncture Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application||||units on a scale||Full Range|Mean
1237515|NCT00603889|Primary|100 Mcg/ml Na-ASP-2 Prick-puncture Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application||||Units on a scale||Full Range|Mean
1237516|NCT00603837|Primary|Neonatal Intensive Care Unit (NICU) Admission Temperature|Axillary temperature of the infant upon arrival to the neonatal intensive care unit.|At time of admission to the NICU - usually within 10-15 min of birth||||Celsius degrees||Standard Deviation|Mean
1237517|NCT00603798|Secondary|Local Skin Reactions (LSR)|Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each visit. These included: Erythema, edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Summary of LSR - area under the curve (AUC) of sum of LSR scores (days).|The time period for the AUC extends to 8 weeks after the end of treatment (Week 17)|All participants were evaluated for local skin reactions (LSR) at every visit. The ITT population was used. Only subjects who received treatment in both cycles are included in the analysis.|||units on a scale * days||Standard Deviation|Mean
1237518|NCT00603798|Secondary|Percent Change From Baseline in AK Lesion Count|Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. A negative percent change is better than a positive percent change.|At all visits - Baseline through the Week 17 EOS visit|Intent to treat (ITT) population using last observation carried forward (LOCF).|||percentage of participants||Full Range|Median
1237519|NCT00603798|Secondary|Number of Participants With Partial Clearance of AK Lesions|Subject status with respect to complete clearance of AK lesions at End of Study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.|End of Study the Week 17 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).|||participants|||Number
1237520|NCT00603798|Primary|Number of Participants With Complete Clearance of AK Lesions|"Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or subclinical lesion that had not been identified at Baseline."|End of Study the Week 17 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF), primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).|||participants|||Number
1237521|NCT00603746|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1237522|NCT00603746|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1237523|NCT00603746|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results|||Nanomoles per 24 hours (nmol/24 hours)||Full Range|Median
1237524|NCT00603746|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||scores on a scale||Standard Deviation|Mean
1237525|NCT00603746|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ratio||Standard Deviation|Mean
1237526|NCT00603746|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cells (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner; results for urinalysis parameters can be read as 1+, 2+, 3+, Large, Moderate, Negative (Neg), Small, and Trace. For UG, the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 2+ or 1/2 G/dL, 3+ or 1 G/dL, 4+ or 2 or more G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had 1+, 2+, 3+, Large, Moderate, Neg, Small, or Trace levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
1237527|NCT00603746|Secondary|Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8|Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1237528|NCT00603746|Secondary|Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8|Blood samples were collected for the measurement of calcium, carbon dioxide content/bicarbonate (CO2/BI), chloride, cholesterol, glucose, phosphorus inorganic (PI), potassium, sodium, and urea at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1237529|NCT00603746|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1237530|NCT00603746|Secondary|Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8|Blood samples were collected for the measurement of ALT, ALP, AST, GGT, and LDH at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1237531|NCT00603746|Secondary|Red Blood Cell Count at Baseline and Week 8|Blood samples were collected for determining the red blood cell count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1237532|NCT00603746|Secondary|Platelet Count and White Blood Cell Count at Baseline and Week 8|Blood samples were collected for determining the platelet count and white blood cell (WBC) count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1237533|NCT00603746|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (G/L)||Standard Deviation|Mean
1237534|NCT00603746|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of hematocrit at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of 1||Standard Deviation|Mean
1237563|NCT00603538|Secondary|Observed Accumulation Ratio (Rac)|The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau|Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.|||ratio||Standard Deviation|Mean
1237815|NCT00602225|Primary|Maximum Tolerated Dose of Clofarabine||45 days after the last dose of clofarabine||||mg/m^2 of clofarabine|||Number
1237535|NCT00603746|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in the blood at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage in the blood||Standard Deviation|Mean
1237536|NCT00603746|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.|From Baseline up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
1237537|NCT00603746|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
1237538|NCT00603746|Secondary|Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
1237539|NCT00603746|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1237540|NCT00603746|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1237541|NCT00603746|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1237542|NCT00603746|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1237559|NCT00603538|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline up to 6 cycles (1 cycle = 21 days)|Full Analysis Set (FAS) was defined as all participants who met all of the following criteria; 1) Those who were diagnosed with NSCLC, 2) Those who received at least one dose of the study treatment, and 3) Those who had efficacy data after the start of the study treatment.|||participants|||Number
1237543|NCT00603746|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.|||Liters||Standard Error|Least Squares Mean
1237544|NCT00603733|Secondary|Frequency of Adverse Events|Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.|From baseline to week 24|Safety dataset for Active and Maintenance Phases|||percentage of patients with TEAEs|||Number
1237545|NCT00603733|Primary|Maintenance Phase: Proportion of Subjects Experiencing Relapse|Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy|Up to week 24|Per Protocol Analysis Set|||% of subjects with relapse (90% CI)||90% Confidence Interval|Number
1237546|NCT00603733|Primary|Active Phase: Proportion of Active Subjects Achieving Overall Improvement|"Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI).~Complete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1.~A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score."|From baseline to week 8|Per Protocol Analysis Set|||percentage of participants||90% Confidence Interval|Number
1237547|NCT00603720|Primary|Effect of NO Inhibition on Myocardial Substrate Metabolism in Humans|Determine in young healthy volunteers the extent to which acute inhibition of nitric oxide production will effect a shift in myocardial substrate utilization characterized as a decline in myocardial fatty acid oxidation, and perhaps myocardial fatty acid utilization, and increase in myocardial glucose uptake, and whether these changes are associated with a decline in LV function.|1-3 months|PI left institution. Efforts were made to access the data, without success so there is no access to the data.|||percentage of substrate||90% Confidence Interval|Mean
1237548|NCT00603642|Secondary|Rescue Medication(s)|Requirement for rescue medication(s) during treatment by the participant|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||Participants|||Number
1237549|NCT00603642|Secondary|Weeks With Platelet Count Between 50 and 200|Number of weeks with platelet count between 50 x 10^9/L and 200 x 10^9/L inclusive during week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||Weeks||Standard Deviation|Mean
1237550|NCT00603642|Secondary|Change From Baseline in Mean of Last 4 Weekly Platelet Counts|Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||10^9/L||Standard Deviation|Mean
1237551|NCT00603642|Secondary|Increased Platelet Count From Baseline of at Least 20 x 10^9/L|An increase in platelet count of at least 20 x 10^9/L from baseline within the participant during the treatment period. Increase was calculated as the maximum observed platelet count during the treatment period minus the baseline platelet count.|Baseline, 12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||Participants|||Number
1237552|NCT00603642|Primary|Weeks With Weekly Platelet Response|Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10^9/L on a weekly scheduled dose day from week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||Weeks||Inter-Quartile Range|Median
1237553|NCT00603590|Secondary|LDL Cholesterol|Serum LDL cholesterol|One year|Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward|||mg/dL||Standard Deviation|Mean
1237554|NCT00603590|Secondary|Diastolic Blood Pressure|Mean of two seated diastolic blood pressures|One year|Analysis by intention to treat. Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward.|||mm Hg||Standard Deviation|Mean
1237555|NCT00603590|Primary|Systolic Blood Pressure|Systolic blood pressure. Mean of two seated measurements.|One year|Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward|||mm Hg||Standard Deviation|Mean
1237556|NCT00603564|Secondary|PaO2/FiO2 Ratio Mantainance|the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement|1, 6, 12, 24 and 48 hours||||participants|||Number
1237557|NCT00603564|Primary|Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315||on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315||||minute||Standard Deviation|Mean
1237558|NCT00603538|Secondary|Progression-Free Survival (PFS)|PFS is the period from the registration to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline up to 6 cycles (1 cycle = 21 days)|Number of participants with defined event (all causality death or PD) was too few to conduct summary analysis.||||||
1237564|NCT00603538|Secondary|Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)|AUCtau: AUC from time zero to tau, the dosing interval, where tau is the actual time of the predose sampling for the next cycle. AUCtau was calculated using the linear/log trapezoidal method.|Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.|||mg*h/mL||Standard Deviation|Mean
1237565|NCT00603538|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)|AUC(0-day22) : AUC from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sampling for the next cycle. AUC(0-day22) was calculated using the linear/log trapezoidal method.|Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.|||mg*h/L||Standard Deviation|Mean
1237566|NCT00603538|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|Participants with sufficient sampling to capture the terminal disposition phase were analyzed.|||hours||Standard Deviation|Mean
1237567|NCT00603538|Secondary|Maximum Observed Concentration (Cmax) of CP-751,871||Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|"The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.~n = the number of participants analyzed"|||mg/L||Standard Deviation|Mean
1237568|NCT00603538|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.|Cycle 1|DLT Evaluation Set comprised of participants who were treated with CP-751,871. One participant in the 10 mg/kg cohort who discontinued from the study due to an adverse event occurred prior to CP-751,871 administration was excluded from this analysis set.|||participants|||Number
1237569|NCT00603525|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.|||Participants|||Number
1237570|NCT00603525|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; TBIL: NA, 1.5; CO2/BCO: 0.85, 1.2; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.|||Participants|||Number
1237571|NCT00603525|Secondary|Number of Participants With a Positive JC Virus Test Result During the Follow-up Period|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. Positive JC Virus test result indicated presence of JC Virus.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237572|NCT00603525|Secondary|Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab|Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.|From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Months||Full Range|Median
1237573|NCT00603525|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period|The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237582|NCT00603525|Secondary|Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237574|NCT00603525|Secondary|Number of Participants With Any Serious Adverse Event During the Follow-up Period|A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])|Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.|||Participants|||Number
1237575|NCT00603525|Secondary|Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicates the presence of JC Virus.|From basline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237576|NCT00603525|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline visit is defined as any visit after the date of infusion A during the specified treatment course. Reference ranges (LLN, ULN) used for immunoglobulins are: immunoglobulin A (IgA) (grams/Liter): 0.81, 4.63; immunoglobulin G (IgG) (grams/Liter): 6.94, 16.18; immunoglobulin M (IgM) (grams/Liter): 0.48, 2.71.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237577|NCT00603525|Secondary|Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237578|NCT00603525|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Monocytes: 0.2, 5 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.7, 5 2; White blood cell count (WBC): 0.7, 1.6.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237579|NCT00603525|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85, 1.2; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Potassium: 0.9, 1.1; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237580|NCT00603525|Secondary|Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237581|NCT00603525|Secondary|Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237627|NCT00603512|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
1237583|NCT00603525|Secondary|Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237584|NCT00603525|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period|The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.|From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
1237585|NCT00603525|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.|First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144|AT Population|||Participants|||Number
1237586|NCT00603525|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||participants|||Number
1237587|NCT00603525|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||participants|||Number
1237588|NCT00603525|Secondary|Time to Retreatment, by Ofatumumab Treatment Course|Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.|From Baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Days||Standard Deviation|Mean
1237589|NCT00603525|Secondary|Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
1237616|NCT00603525|Secondary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, and 20|ITT Population|||participants|||Number
1237590|NCT00603525|Secondary|Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
1237591|NCT00603525|Secondary|Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||scores on a scale||Standard Deviation|Mean
1237592|NCT00603525|Secondary|Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).|First 24 weeks of each treatment course (assessed up to Week 144)|As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period|||Scores on a scale||Standard Deviation|Mean
1237593|NCT00603525|Secondary|Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24|The following immunoglobulins were assessed: IgA, IgG and IgM. Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression.|Baseline, Week 12, and Week 24|Safety Population: identical to the ITT population except that participants were analyzed according to their actual treatment when this differed from their randomized treatment. Only those participants contributing values at baseline and the relevant visit were analzyed.|||grams per Liter (g/L)||Full Range|Median
1237594|NCT00603525|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Week 24|Detection of human anti-human antibodies (HAHAs) against ofatumumab was to be performed by Electrochemiluminescent (ECL) Meso-Scale Discovery (MSD) immunoassay. Positive samples from the binding antibody test were also tested in a neutralizing antibody assay.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
1237595|NCT00603525|Secondary|Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4|The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.|Baseline and Week 4|ITT Population. Only those participants contributing values at the relevant visit were analyzed.|||Units/Liter||Full Range|Median
1237596|NCT00603525|Secondary|Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
1237617|NCT00603525|Primary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.|||participants|||Number
1237597|NCT00603525|Secondary|Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
1237598|NCT00603525|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24|"The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
1237599|NCT00603525|Secondary|Change From Baseline in the Physician-assessed Global Disease Score Using VAS at Week 24|"The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
1237600|NCT00603525|Secondary|Change From Baseline in Participant-assessed Global Disease Score Using VAS at Week 24|"The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
1237601|NCT00603525|Secondary|Change From Baseline in the Participant-assessed Pain Score Using Visual Analogue Scale (VAS) at Week 24|"A horizontal VAS of 100 mm was used to report the participant’s level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
1237602|NCT00603525|Secondary|Change From Baseline in ESR at Week 24|ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||millimeters per hour (mm/hr)||Full Range|Median
1237603|NCT00603525|Secondary|Change From Baseline in CRP at Week 24|Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||milligrams per liter (mg/L)||Full Range|Median
1237604|NCT00603525|Secondary|Change From Baseline in Swollen Joint Count at Week 24|Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||swollen joints||Full Range|Median
1237605|NCT00603525|Secondary|Change From Baseline in Tender Joint Count at Week 24|Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||tender joints||Full Range|Median
1237606|NCT00603525|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24|The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||scores on a scale||Full Range|Median
1237607|NCT00603525|Secondary|Median of the Largest Integer n, for Which a Participant Met the ACR Criteria Requiring an Improvement of n% (ACRn) at Weeks 4, 8, 12, 16, 20, and 24|ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percentage (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = min(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
1237608|NCT00603525|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
1237609|NCT00603525|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
1237610|NCT00603525|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||scores on a scale||Standard Deviation|Mean
1237611|NCT00603525|Secondary|Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at the relevant visit were analyzed.|||scores on a scale||Standard Deviation|Mean
1237612|NCT00603525|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||scores on a scale||Standard Deviation|Mean
1237613|NCT00603525|Secondary|Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at the relevant visit were analyzed.|||scores on a scale||Standard Deviation|Mean
1237614|NCT00603525|Secondary|Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
1237615|NCT00603525|Secondary|Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
1237618|NCT00603512|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-F is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1237619|NCT00603512|Secondary|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 2, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1237620|NCT00603512|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1237621|NCT00603512|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1237622|NCT00603512|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1237623|NCT00603512|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (=<) 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1237624|NCT00603512|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-n is measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute AUC.|Baseline up to Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||units on a scale*weeks||Standard Deviation|Mean
1237625|NCT00603512|Secondary|Numeric Index of American College of Rheumatology Response (ACR-n)|ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||units on a scale||Standard Deviation|Mean
1237626|NCT00603512|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
1237628|NCT00603512|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1237629|NCT00603512|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1237630|NCT00603512|Secondary|Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1237631|NCT00603512|Secondary|Physician Global Assessment (PGA) of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1237632|NCT00603512|Secondary|Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1237633|NCT00603512|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1237634|NCT00603512|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 = no pain and 100 = most severe pain.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1237635|NCT00603512|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 = no pain and 100 = most severe pain.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1237636|NCT00603512|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Deviation|Mean
1237637|NCT00603512|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Deviation|Mean
1237638|NCT00603512|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Deviation|Mean
1237639|NCT00603512|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Deviation|Mean
1237640|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: >= 90% improvement in tender or swollen joint counts and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||Percentage of Participants|||Number
1237641|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in tender or swollen joint counts and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||Percentage of Participants|||Number
1237642|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in tender or swollen joint counts and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/End of Treatment (EOT)|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||Percentage of Participants|||Number
1237643|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||Percentage of Participants|||Number
1237644|NCT00603512|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using Last observation carried forward (LOCF) method.|||Percentage of Participants|||Number
1237645|NCT00603473|Secondary|Percent Change in Seizure Frequency (PCH)|PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T−B) / B where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.|||Percent Change||Full Range|Median
1237646|NCT00603473|Secondary|Responder Rate|Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.|||Percentage of Subjects||95% Confidence Interval|Mean
1237647|NCT00603473|Primary|Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures|The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T−B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.|||ratio||95% Confidence Interval|Mean
1237648|NCT00603447|Primary|Number of Participants With Dose-limiting Toxicities|"Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic~≥ Grade 2 neuropathy with pain~≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide)~≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy~≥ Grade 4 fatigue persisting > 7 days~Treatment delay for toxicity > 21 days~Hematologic~Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) > 7 days~Febrile neutropenia (ANC < 1,000/mm³ with fever ≥ 38.3ºC)~Grade 4 thrombocytopenia (platelets < 25,000/mm³) for > 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding~Treatment delay for toxicity > 21 days.~The maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort."|Cycle 1, 28 days|Safety population for the dose escalation portion of the study|||participants|||Number
1237673|NCT00603382|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.|From Baseline up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
1237731|NCT00603239|Secondary|Change in Insulin Sensitivity.|Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||ratio||Standard Error|Least Squares Mean
1237649|NCT00603447|Primary|Number of Participants With Adverse Events (AEs)|"Treatment-related are those AEs with possible or probable relationship to carfilzomib, lenalidomide or dexamethasone as assessed by the Investigator. The severity of each adverse event was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, per the following: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.~Serious adverse events were defined as AEs meeting one of the following: death, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in the offspring of an exposed participant, important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above, or pregnancy or suspected pregnancy."|From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.|Safety population consisting of all treated participants|||participants|||Number
1237650|NCT00603408|Secondary|Provide Samples for the Development of the FNA Assay||At time of IVAD placement and at time of surgery|Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.||||||
1237651|NCT00603408|Secondary|Develop Animal Models of Triple Negative Breast Cancers||5 years|Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.||||||
1237652|NCT00603408|Secondary|Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response||5 years|Collecting bone marrow samples were optional and at the time of surgery only 2 patients participated and at the time of port removal submission none of the patients participated.||||||
1237653|NCT00603408|Secondary|Number of Participants With Medical Toxicities|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.|30 days post surgery (week 17-18)||||participants|||Number
1237654|NCT00603408|Secondary|Number of Participants With Surgical Complications||30 days post surgery (week 17-18)||||participants|||Number
1237655|NCT00603408|Secondary|Overall Survival Rate (OS)|OS = Time from registration until death from any cause|Until study was terminated (23.5 months)||||percentage of participants|||Number
1237656|NCT00603408|Secondary|Time to Disease Progression|Time to disease progression: time from registration until objective tumor progression; does not include deaths|Until study was terminated (23.5 months)|At the time of study termination, no participants had experienced disease progression.||||||
1237657|NCT00603408|Primary|Overall Response|"Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level~Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started,~Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions."|At the time of surgery (week 13)||||participants|||Number
1237658|NCT00603382|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1237659|NCT00603382|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1237660|NCT00603382|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24 hr urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visits 3 (Week 0) and Visit 8 (Week 8). The Baseline value for 24 hr urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.|||Nanomoles per 24 hours (nmol/24 hours)||Full Range|Median
1237661|NCT00603382|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||scores on a scale||Standard Deviation|Mean
1237662|NCT00603382|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ratio||Standard Deviation|Mean
1237732|NCT00603239|Secondary|Change in Beta-cell Function|Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||ratio||Standard Error|Geometric Mean
1237663|NCT00603382|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as large, moderate (Mod), negative (Neg), small, Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
1237664|NCT00603382|Secondary|Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8|Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1237665|NCT00603382|Secondary|Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8|Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1237666|NCT00603382|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1237667|NCT00603382|Secondary|Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8|Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1237668|NCT00603382|Secondary|Red Blood Cells (RBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1237669|NCT00603382|Secondary|Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1237670|NCT00603382|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (G/L)||Standard Deviation|Mean
1237671|NCT00603382|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of 1||Standard Deviation|Mean
1237672|NCT00603382|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage||Standard Deviation|Mean
1237674|NCT00603382|Secondary|Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
1237675|NCT00603382|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
1237676|NCT00603382|Secondary|Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1237677|NCT00603382|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1237678|NCT00603382|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at th end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1237679|NCT00603382|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1237680|NCT00603382|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1(the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.|||Liters||Standard Error|Least Squares Mean
1237688|NCT00603304|Secondary|Prostate Specific Antigen (PSA) Level|The mean difference in the PSA level from baseline to 72 weeks in the modified intention to treat analysis. The PSA level was measured in nanograms/milliliters. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||ng/mL||95% Confidence Interval|Mean
1237681|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale consists of three self administered questions. Two of the questions are scored on a scale of 0 – 3, with zero being none, one being only a little, two being some, and three being a lot. The third question is scored on a scale of 0 -6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed (equally satisfied and dissatisfied), four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 12, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237682|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale consists of two self administered questions. The questions are scored on a scale from 0 – 5, with zero being not at all, one being less than 1 time in 5, two being less than half the time, three being about half the time, four being more than half the time, and five being almost always. The lowest possible score is 0 and the highest possible score is 10, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237683|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale is a four item self administered questionnaire. Three of the four items are scored on a scale from 0 – 1, with zero being no and one being yes. The fourth item is scored on a scale from 0 – 10, with zero being no pain and ten being pain as bad as you can imagine. The lowest possible score is 0 and the highest possible score is 21, which represents the highest level of pain.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237684|NCT00603304|Secondary|Jenkins Sleep Scale Score|The mean difference in the Jenkins Sleep Dysfunction score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. Jenkins Sleep Dysfunction score is used to assess sleep dysfunction. The four item self administered questionnaire is scored on a scale from 0 to 5, with zero being not at all, one being 1 -3 days, two being 4 – 7 days, three being 8 – 14 days, four being 15 – 21 days, and five being 22 – 31 days. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237685|NCT00603304|Secondary|International Continence Society Male Incontinence Symptom (ICSmale IS) Score|The mean difference in the ICSmaleIS score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The six item self administered questionnaire is scored on a scale from 0 to 4, with zero being never, one being occasionally, two being sometimes, three being most of the time, and four being all of the time. The lowest possible is 0 and the highest possible score is 24, which represents the the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237686|NCT00603304|Secondary|Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.|The mean difference in the MSHQ-EjD from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The MSHQ-EjD scale is used for the assessment ejaculatory dysfunction (EjD). The MSHQ-EjD consists of four self administered questions. Three of the items are scored on a scale from 0 to 5, with zero being all the time, one being most of the time, two being some of the time, three being a little of the time, four being none of the time, and five being no sexual activity. The fourth item is scored on a scale of 1 – 5, with one being not at all bothered, two being a little bit bothered, three being moderately bothered, four being very bothered, and five being extremely bothered. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.|Baseline to 72 weeks.|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237687|NCT00603304|Secondary|International Index of Erectile Function (IIEF)Scale Score.|The mean difference in the IIEF score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IIEF is a multidimensional scale for assessment of erectile dysfunction. The six item self administered questionnaire is scored on a scale from 0 to 5, with zero being no sexual activity, one being never or almost never, two being a few times (much less than half the time), three being sometimes (much less than half the time), four being most times (much more than half the time), and five being always or almost always. The lowest possible score is 0 and the highest possible score is 30, which represents less dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237711|NCT00603278|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Proportion of 1||Standard Deviation|Mean
1237689|NCT00603304|Secondary|Post-void Residual|The mean difference in the participants' post-void residual from baseline to 72 weeks in the modified intention to treat analysis. The post-void residual was measured in milliliters. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses.|||mL||95% Confidence Interval|Mean
1237690|NCT00603304|Secondary|Peak Uroflow|The mean difference in the participants' peak uroflow from baseline to 72 weeks in the modified intention to treat analysis. The peak uroflow was measured in milliliters/seconds. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||mL/sec||95% Confidence Interval|Mean
1237691|NCT00603304|Secondary|American Urological Association(AUA) Nocturia Item|The mean difference in the nocturia item of the AUA Symptom Score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The nocturia item is a self administered question from the AUA Symptom Score Index that assesses the number of times a participant typically gets up to urinate from the time he goes to bed at night until the time he gets up in the morning. The question is scored on a scale of zero to five, with zero being none, one being one time, two being two times, three being three times, four being four times, and five being five or more times. The lowest possible score is 0 and the highest possible score is 5, which would represent the highest level dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237692|NCT00603304|Secondary|International Prostate Symptom Score Quality of Life (IPSS QOL) Score|The mean difference in the IPSS Quality-of-Life Question from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IPSS Quality-of-Life Question is an additional question to the AUA Symptom Score. The self administered question is scored on a scale from 0 to 6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed-about equally satisfied and dissatisfied, four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 6, which would represent the greatest dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237693|NCT00603304|Secondary|Benign Prostate Hyperplasia (BPH) Impact Index Score|The mean difference in the BPH Impact Index score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The BPH Index Score is a self administered 4 item index. Three questions are scored on a scale from 0 to 3, with zero being none, one being only a little, two being some, and three being a lot. One question is scored on a scale from 0 to 4, with zero being none of the time, one being a little of the time, two being some of the time, three being most of the time, and four being all of the time. The lowest possible score is 0 and the highest possible score is 13, which would represent the greatest dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237694|NCT00603304|Secondary|Participants Global Assessments of Improvement and Satisfaction at End of Study.|Participants' global assessments of improvement and satisfaction at the end of the study. Likert scales were transformed to a 0 - 100 scale. The lowest possible score is 0 and the highest possible score is 100, which would reflect better outcomes.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237695|NCT00603304|Primary|Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.|The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
1237696|NCT00603291|Secondary|Percent Change in Body Weight From Baseline to Week 52|The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF|||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
1237697|NCT00603291|Primary|Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.~Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF|||percentage of participants|||Number
1237698|NCT00603278|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1237699|NCT00603278|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1237733|NCT00603239|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||cm||Standard Deviation|Mean
1237700|NCT00603278|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.|||Nanomole per 24 hours (nmol/24hr)||Full Range|Median
1237701|NCT00603278|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||scores on a scale||Standard Deviation|Mean
1237702|NCT00603278|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Urine specific gravity at Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ratio||Standard Deviation|Mean
1237703|NCT00603278|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1237704|NCT00603278|Secondary|Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8|Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1237705|NCT00603278|Secondary|Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8|Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1237706|NCT00603278|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Grams per liter (G/L)||Standard Deviation|Mean
1237707|NCT00603278|Secondary|Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8|Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
1237708|NCT00603278|Secondary|Red Blood Cells (RBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1237709|NCT00603278|Secondary|Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1237710|NCT00603278|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Grams per liter (G/L)||Standard Deviation|Mean
1237712|NCT00603278|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Deviation|Mean
1237713|NCT00603278|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.|From Baseline up to Week 8/Early Withdrawal|ITT Population|||Participants|||Number
1237714|NCT00603278|Secondary|Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population|||Participants|||Number
1237715|NCT00603278|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population|||Participants|||Number
1237716|NCT00603278|Secondary|Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1237717|NCT00603278|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1237718|NCT00603278|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1237719|NCT00603278|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1237729|NCT00603239|Secondary|Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score|IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = “never true” to 5 = “always true.”|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||units on a scale||Standard Error|Least Squares Mean
1237730|NCT00603239|Secondary|Number of Subjects Who Experienced an Episode of Minor Hypoglycemia|Overall number of subjects who experienced an episode of minor hypoglycemia.|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||Participants|||Number
1237734|NCT00603239|Secondary|Change in Body Weight|Change in body weight from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||kg||Standard Error|Least Squares Mean
1237720|NCT00603278|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.|||Liters||Standard Error|Least Squares Mean
1237721|NCT00603265|Secondary|Change From Baseline in NPRS After Walking 50 Feet in the Clinic|The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken after the participant walked 50 feet in the clinic. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.|Baseline, Week 1, Week 2, Week 3, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable post-walk NPRS data.|||units on a scale||Standard Error|Least Squares Mean
1237722|NCT00603265|Secondary|Change From Baseline in NPRS at Rest in the Clinic|The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken while the participant was at rest. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.|Baseline, Week 1, Week 2, Week 3, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable at-rest NPRS data.|||units on a scale||Standard Error|Least Squares Mean
1237723|NCT00603265|Secondary|Change From Baseline in the Evening Assessment of the 24-hour Overall Mean Pain Intensity Score|At each of the evening pain assessments, participants assessed their overall pain intensity over the preceding 24 hours using NPRS. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained at Baseline and Week 4. Change from baseline = NPRS at baseline - NPRS at Week 4.|Baseline, Week 4|All participants who received at least 1 dose of study medication and had evaluable 24-hour NPRS data.|||units on a scale||Standard Deviation|Mean
1237724|NCT00603265|Secondary|Change in Sleep Interference Scale (SIS) From Baseline|"Sleep Interference was assessed on an 11-point Numeric Rating Scale where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2, and 3 because a participant could have had multiple visits during Month 1, 2, and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. LS means were calculated using ANCOVA with treatment group as a main factor and baseline SIS score as a covariate. Change from baseline = SIS score at baseline - SIS score at Week 4."|Baseline, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable SIS data|||units on a scale||Standard Error|Least Squares Mean
1237725|NCT00603265|Secondary|Patient Global Impression of Change (PGIC)|PGIC is a participant-rated instrument that measures the change in the participant’s overall status for the previous 2 weeks based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The number of participants in each category is presented.|Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable PGIC data.|||participants|||Number
1237726|NCT00603265|Secondary|Percentage of Responders|A responder was defined as a participant who showed a reduction in average pain (as measured by NPRS) of at least 30% from baseline to Week 4. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The percentage of participants who qualified as responders is presented per treatment arm.|Baseline, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable NPRS data.|||percentage of participants|||Number
1237727|NCT00603265|Primary|Change From Baseline in Mean Numeric Pain Rating Scale (NPRS) Score|The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicates a reduction in pain intensity from baseline.|Baseline, Week 4|All participants who received at least 1 dose of study medication and had evaluable NPRS data. Baseline-observation-carried-forward (BOCF) was used to impute missing postbaseline values for participants who were discontinued from the study early.|||units on a scale||Standard Error|Least Squares Mean
1237728|NCT00603239|Secondary|Change in Euroqol – 5 Domain Quality of Life (EQ-5D) Score|EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||units on a scale||Standard Error|Least Squares Mean
1237737|NCT00603239|Secondary|Percentage of Patients Achieving HbA1c <= 7%|Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||percentage of participants|||Number
1237738|NCT00603239|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)|baseline and 26 weeks|The number of participants was determined based on sample size calculations using parameter estimates from prior study H8O-MC-GWAP (NCT00099320), with change from baseline HbA1c as the primary efficacy measure. Primary analysis is reported for intent to treat population (ITT), last observation carried forward (LOCF).|||Percentage||Standard Error|Least Squares Mean
1237739|NCT00603187|Secondary|LH Blood Serum Concentration|Blood for measurement of serum leutenizing hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days||||iu/L||Standard Deviation|Mean
1237740|NCT00603187|Secondary|FSH Blood Serum Concentration|Blood for measurement of serum follicle stimulating hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days||||iu/L||Standard Deviation|Mean
1237741|NCT00603187|Primary|Testosterone Blood Serum Concentration|Blood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days||||ng/dl||Standard Deviation|Mean
1237742|NCT00603044|Secondary|Adjusted Volume of the Removed Adenoids|To adjust for different weights of the children, the volume of the adenoids, estimated by water displacement in the operating room in mL, was divided by the respective weights (kg) of the patients and multiplied by 100.|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||mL/kg x100||Standard Error|Mean
1237743|NCT00603044|Primary|Amount of TGF Secreted by Adenoid Cells After PHA Stimulation|Amount of TGF secreted by adenoid cells after PHA stimulation|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||picogram per milliliter (pg/mL)||Full Range|Median
1237744|NCT00603044|Primary|Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation|Amount of IL-10 secreted by adenoid cells after PHA stimulation|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||picogram per milliliter (pg/mL)||Full Range|Median
1237745|NCT00603044|Primary|IL-10 Staining Intensity|IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||IOD/100 micrometer squared||Standard Error|Mean
1237746|NCT00603044|Primary|Number of CD4 Pos/FOXP3 Positive Cells|The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||cells per High power field (HPF)||Full Range|Median
1237747|NCT00603044|Primary|Number of CD25 Pos/FoxP3 Positive Cells|The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||cells per High power field (HPF)||Full Range|Median
1237748|NCT00603018|Primary|Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors|We used PET and [11C]WAY to assess 5-HT1A binding potential (BP) = [11C]WAY 100635 BP = Distribution Volume (DV)ROI−DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3|Baseline and 8 weeks||||mL/cm^3||Standard Deviation|Mean
1237749|NCT00602979|Primary|Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System.|"Percentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible.~Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4."|1 time during laryngoscopy||||units on a scale||Standard Deviation|Mean
1237750|NCT00602953|Primary|Disposition Index (DI)|Disposition index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Disposition index (DI) was used to characterize the correlation between β-cell sensitivity and insulin sensitivity and was determined using formula DI = AIRg x SI (from outcomes 2 and 3). Higher numbers indicates a better improvement in beta-cell function.|At screening visit.||||Number||Inter-Quartile Range|Median
1237751|NCT00602953|Primary|Insulin Sensitivity (SI)|"Sensitivity index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI).~Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Higher numbers indicates better insulin sensitivity Insulin sensitivity was estimated as Matsuda index using formula = 10,000 / (FPG x FPI x Glucosemean0-180 x Insulinmean0-180)0.5, where FPG = fasting plasma glucose and FPI = fasting plasma insulin."|At screening visit.||||min-1 per pU/mL x 10v4||Inter-Quartile Range|Median
1237752|NCT00602953|Primary|Beta-cell Function; AIRg - Acute Insulin Response to Glucose|"Beta-cell function as measured by frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI).~AIRg - acute insulin response to glucose. Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected."|At screening visit.||||microU/mL x min||Inter-Quartile Range|Median
1237753|NCT00602953|Primary|Pancreatic and Liver Fat|Pancreatic and liver triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).|Within 1 month after screening visit.||||percent||Inter-Quartile Range|Median
1237754|NCT00602927|Secondary|Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time)|We examined the difference in correct reaction time on the N-back task between varenicline and placebo treatment. Models included terms for the main effect of treatment period (varenicline vs. placebo), memory load (0-back, 1-back, 2-back, 3-back) and covariates. We tested for interactions between nicotine dependence severity and treatment.|Day 13|Participants who completed both study phases were included in the analysis. Other participants (n=3) were excluded due to measurement artifact.|||Milliseconds||Standard Deviation|Mean
1237755|NCT00602927|Primary|Percent Change BOLD Signal|We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.|Day 13|Participants who completed both study phases were included in the analyses (n=25). Additional participants (n=3) were excluded due to measurement artifact.|||BOLD Signal Change (3-back minus 0-back)||Standard Error|Mean
1237756|NCT00602836|Secondary|Number of Participants With FISH Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. FISH status describe in baseline characteristics section.|During treatment (up to 5 years)|||||||
1237757|NCT00602836|Secondary|Number of Participants With ZAP-70 Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. ZAP-70 status describe in baseline characteristics section.|During treatment (up to 5 years)|||||||
1237758|NCT00602836|Secondary|Number of Participants With CD38 Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. CD38 status described in baseline characteristics section.|During treatment (up to 5 years)|||||||
1237759|NCT00602836|Secondary|Number of Participants With IgVH Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. IgVH mutation status describe in baseline characteristics section.|During treatment (up to 5 years)|||||||
1237760|NCT00602836|Secondary|Time to Disease Progression (TTP)|Time to disease progression (TTP) was defined as the time from registration to the earliest date documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median TTP with 95% CI was estimated using the Kaplan Meier method.|time from registration to progression (up to 5 years)|||||||
1237761|NCT00602836|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.|time from registration to death (up to 5 years)|||||||
1237762|NCT00602836|Secondary|Number of Participants With a Response (CR, nPR, PR)|Response criteria described in above outcomes|During treatment (up to 5 years)|||||||
1237763|NCT00602836|Secondary|Number of Participants Who Convert From a CR With MRD or nPR, PR, or Stable Disease With Residual Disease After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide||12 months|||||||
1237764|NCT00602836|Secondary|Number of Participants Who Convert From a CR With Minimal Residual Disease (MRD) Positive Status After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells to determine if there was any MRD.|12 months|||||||
1237765|NCT00602836|Secondary|Number of Participants Who Convert From a Nodular Partial Response (nPR), Partial Response (PR), or Stable Disease (SD) After Pentostatin, Cyclophosphamide, and Rituximab (PCR) to a Complete Response (CR) After 6 Courses of Consolidation With Lenalidomide|"According to the NCIWG criteria, response is defined as follows:~nPR: Meets all criteria for CR, as described above, except the presence of residual clonal nodules in the bone marrow PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions SD: participant who does not meet any of the criteria described above"|12 months|||||||
1237766|NCT00602836|Primary|Number of Participants With Complete Response (CR)|"A complete response, as defined by the National Cancer Institute Working Group (NCIWG), requires all of the following for a period of at least 2 months:~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy"|12 months||||participants|||Number
1237767|NCT00602797|Secondary|Response Rate Based on RECIST Criteria|The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter|Up to 5 years||||Participants|||Count of Participants
1237768|NCT00602797|Secondary|Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events|Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events.|Up to week 17||||Participants|||Count of Participants
1237889|NCT00601354|Primary|Weight Loss|Change in weight in lbs from per to post treatment|3 months: Measured from pre to post treatment|Used intent-to-treat analysis|||lbs||Standard Deviation|Mean
1237769|NCT00602797|Primary|Progression-free Survival.|Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions.|Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years||||Months||95% Confidence Interval|Median
1237770|NCT00602771|Primary|Complete Response|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.|6 months||||participants|||Number
1237771|NCT00602641|Secondary|Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12|A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome).|Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.|Patients who completed both baseline and cycle 12 QOL assessments.|||units on a scale||Standard Deviation|Mean
1237772|NCT00602641|Secondary|Very Good Partial Response (VGPR) Rate|Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria.|Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.|Intention-to-treat (ITT) population|||proportion of participants||95% Confidence Interval|Number
1237773|NCT00602641|Secondary|Overall Survival|Overall survival was defined as time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.|Intention-to-treatment (ITT) population|||months||95% Confidence Interval|Median
1237774|NCT00602641|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the earlier of progression or death of any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.|Intention-to-treat (ITT) population|||months||95% Confidence Interval|Median
1237775|NCT00602537|Secondary|Treatment-Emergent Mood Symptoms|These subjects must be responders.|Measured at Weeks 12 and 36||||Participants|||Count of Participants
1237776|NCT00602537|Primary|Depressive Relapse|"These subjects must be responders. Outcome measures were obtained at continuation weeks. Participant would be considered depressive relapse if relapsed by any of these times."|Weeks 16, 20, 24, 30, 36||||Participants|||Count of Participants
1237777|NCT00602472|Secondary|Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237778|NCT00602472|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237779|NCT00602472|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237780|NCT00602472|Secondary|Percentage of Patients With HbA1c < 7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237781|NCT00602472|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1238135|NCT00599313|Secondary|Prostate Specific Antigen (PSA) Response|Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline.|Baseline and up to 12 months|Evaluable population|||percentage of participants||95% Confidence Interval|Number
1237782|NCT00602472|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1237783|NCT00602472|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1237784|NCT00602472|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1237785|NCT00602472|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1237786|NCT00602472|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1237787|NCT00602472|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|"The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment.~HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule."|||Percent||Standard Error|Mean
1237788|NCT00602472|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1237789|NCT00602472|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1237790|NCT00602459|Secondary|Time-to-progression in Patients With Del(11q22.3)|Time to progression (TTP) in del(11q22.3) participants was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.|Up to 15 years|This endpoint is limited to patients with del(11q22.3).|||months||95% Confidence Interval|Median
1237791|NCT00602459|Secondary|Time-to-progression in Patients Without Del(11q22.3)|Time to progression (TTP) was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progressive disease (PD) required at least one of the following: >= 50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes, >= 50% increase in the product of at least two lymphnodes, >= 50% increase in the enlargement of the liver and/or spleen.|Up to 15 years|This endpoint is limited to patients without del(11q22.3).|||months||95% Confidence Interval|Median
1237792|NCT00602459|Secondary|PFS Rate of Patients With Del(11q22.3)|Proportion of del (11q22.3) participants who were alive and progression free at 2 years.|2 years|This endpoint is limited to patients with del(11q22.3).|||proportion of participants||90% Confidence Interval|Number
1237793|NCT00602459|Secondary|Overall Response Rates in Patients With Del(11q22.3)|Percentage of del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.|Up to 15 years|Patients with del(11q22.3) were included in this analysis.|||percentage of participants||90% Confidence Interval|Number
1237794|NCT00602459|Secondary|Overall Response Rate in Patients Without Del(11q22.3)|Percentage of non-del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.|Up to 15 years|Patients without Del(11q22.3) were included in this analysis.|||percentage of participants||90% Confidence Interval|Number
1237795|NCT00602459|Primary|2-Year Progression Free Survival (PFS) Rate|Proportion of participants who were alive and progression free at 2 years.|2 years|Patients re-assigned to Arm C were split into two analysis groups, patients with del(11q22.3), as assessed by interphase cytogenetics and present in at least 20% of cells, and those without del(11q22.3). This endpoint is limited to patients without del(11q22.3).|||proportion of participants||90% Confidence Interval|Number
1237796|NCT00602446|Secondary|Reduction in Liver Iron Concentration After Study Drug|Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline (LIC at baseline minus LIC at 6 months). This shows the mean reduction for the 3 subjects treated in this study.|6 Months|All patients included in count.|||milligrams/gram||Standard Deviation|Mean
1237797|NCT00602446|Primary|Number of Patients Not Completing Treatment|Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity|6 Months|Note: 1 patient had a transient decrease in hemoglobin that required discontinuation of treatment for 2 weeks; subsequently restarted at same dose and completed therapy.|||Participants|||Number
1237798|NCT00602420|Primary|Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.|Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)*Days.|From baseline through day 5||||(Pain Scale Score)*Days||95% Confidence Interval|Mean
1237799|NCT00602355|Secondary|Hamilton Anxiety Rating Scale (HARS)|Measure total ranges from 0 to 56, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
1237800|NCT00602355|Secondary|Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)|Measure total ranges from 1 to 5, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
1237801|NCT00602355|Secondary|Global Illness Severity Based on Clinical Global Impression (CGI) Scale|Measure total ranges from 1 to 7, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
1237802|NCT00602355|Secondary|Depression Illness Severity Based on Beck Depression Inventory (BDI)|Measure total ranges from 0 to 56, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
1237803|NCT00602355|Primary|Hamilton Depression Rating Scale (HAM-D)|Measure total ranges from 0 to 50, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
1237804|NCT00602290|Secondary|Quality of Life Assessment|The Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The total score is reported for items 1-14. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with higher values representing a better outcome.|Measured at Baseline and Week 16|The overall analyzed at baseline and week 16 differs due to participant drop out.|||units on a scale||Standard Deviation|Mean
1237805|NCT00602290|Primary|Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16|The Hamilton Depression Rating Scale (HDRS) is a 24-item depression scale and the total score is summed with a minimum score=0 and maximum score=76. There are no subscales and the higher values represent a worse outcome. Outcomes are measured and defined as follows: 1) Response will be defined as HDRS scores of 10 or less; 2) Sustained response will be defined as maintained response at week 16; 4) Remission will be defined as HDRS scores of 6 or less.|Maintained response measured at Week 16||||units on a scale||Standard Deviation|Mean
1237806|NCT00602225|Secondary|Overall Survival||At five years after the last dose of clofarabine||||months||95% Confidence Interval|Median
1237807|NCT00602225|Secondary|Disease-free Survival|Number of participants who survived and were disease-free at 5 years|At five years after the last dose of clofarabine||||Participants|||Count of Participants
1237808|NCT00602225|Secondary|Efficacy|Number of Patients Surviving at Five Years|At five years after the last dose of clofarabine||||Participants|||Count of Participants
1237809|NCT00602225|Secondary|Hematologic and Non-hematologic Side Effect Profile||45 days after the last dose of clofarabine|Data not collected||||||
1237810|NCT00602225|Primary|Response Rates by Salvage Number|Number of participants in each Salvage number category who achieved a Complete Remission. Salvage number refers to whether treatment with GCLAC on this study was the pariticipant's first salvage regimen (1), second salvage regimen (2), or third or greater salvage regimen (3 or greater).|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.|||Participants|||Count of Participants
1237811|NCT00602225|Primary|Response Rates by Duration First Complete Remission (CR1)|Number of participants whose first Complete Remission lasted 0, 1-6, 6-12, or greater than 12 months. Only those participant who had a first CR are included in this data.|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.|||Participants|||Count of Participants
1237812|NCT00602225|Primary|Response Rates by Cytogenetic Risk Category and Clofarabine Dose|Number of participants under each Cytogenetic Risk Category and Clofarabine dose who achieve CR (Complete Remission = less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) or CRp (Complete Remission, but with a platelet count of less than 100,000/microL).|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.|||Participants|||Count of Participants
1237813|NCT00602225|Primary|Response Rates by Cytogenetic Risk Category|Number of participants who achieved Complete Remission (less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) under each cytogenetic risk category.|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.|||Participants|||Count of Participants
1237816|NCT00602043|Secondary|Correlation of FES Uptake With ER Assays|Graphical and numerical studies of bivariate relationships will be examined, as well as factors (i.e., tumor size, tumor location, patient age) to explain concurrence, lack of concurrence, and sources of measurement error for measurements of ER function.|Up to 6 months|Data were not collected due to variations in reporting methods for ER assays.||||||
1237817|NCT00602043|Secondary|Time to Progression|FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of time to progression. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.|Up to 6 months||||months||Full Range|Median
1237818|NCT00602043|Secondary|Number of Participants With Clinical Benefit|"FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of clinical benefit.~Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months.~The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months)."|Up to 6 months||||Participants|||Count of Participants
1237819|NCT00602043|Primary|Best Overall Response|"Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease [per response evaluation criteria in solid tumors (RECIST, version 1.1)], size-based response criteria were used to assess response.~For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD).~The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months)."|Up to 6 months||||patients with progressive disease|||Number
1237820|NCT00601965|Primary|Penn State Worry Questionnaire|The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry.|56 weeks||||units on a scale||Standard Deviation|Mean
1237821|NCT00601965|Primary|Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score >= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of >=5, for a total Hamilton >=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety).|56 weeks||||participants|||Number
1237822|NCT00601952|Primary|Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)|The PCL-M is a 17-item questionnaire that assesses the severity of PTSD symptoms using a 5-point Likert scale ranging from “not at all” to “extremely,” with a minimum score of 17 and a maximum score of 85 (Weathers, Litz, Herman, Huska, & Keane, 1993). Participants are asked to rate to what extent they experienced PTSD symptoms over the previous month due to prior combat experiences. The military version of the PCL (PCL-M) refers specifically to a traumatic military related event (Weathers, Litz, Huska, & Keane, 1994). Research suggests that the PCL-M has good test-retest reliability (r = .70) and internal consistency (alpha = .97; Weathers et al., 1993).|Pre, Post, Followup||||units on a scale||Standard Deviation|Mean
1237823|NCT00601926|Secondary|Safety of Bevacizumab in This Population of Patients|Grade 3 or higher toxicities according to CTCAE version 3.0|Up to 2 years||||toxicities|||Number
1237824|NCT00601926|Primary|Response Rate to Bevacizumab in This Population.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Up to 2 years|Includes patients with Complete response, partial response or stable disease|||patients|||Number
1237825|NCT00601926|Primary|Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.|Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||months||Full Range|Median
1237826|NCT00601900|Secondary|Treatment Related Toxicity|Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Tabulated by type, grade, and arm.|Up to 5 years|||||||
1237827|NCT00601900|Secondary|Time-to-treatment Failure|From randomization until first disease progression, early termination of protocol therapy due to toxicity or withdrawn consent, or going onto non-protocol therapy. Defined by RECIST criteria. The proportional hazards model will be used to compare the arms on time-to-treatment-failure|Up to 5 years|||||||
1237828|NCT00601900|Secondary|Site of Progression||Up to 5 years|||||||
1237829|NCT00601900|Secondary|Probability of Surviving Until 36 Months||At 36 months|||||||
1237830|NCT00601900|Secondary|Duration of Tumor Response|Defined by RECIST criteria.|From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|||||||
1237831|NCT00601900|Secondary|Overall Survival (OS)|OS is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|Assessed up to 5 years|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.|||months||95% Confidence Interval|Median
1237832|NCT00601900|Secondary|Objective Response Rate|Response was defined using RECIST criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.|Assessed up to 5 years|Per protocol, the analysis of this endpoint was restricted to patients that elected letrozole as endocrine therapy and began treatment with measureable disease. A total of 213 patients (Arm A:106; Arm B:107) had measureable disease. Of the 213, 197 (Arm A:98, Arm B:99) patients were assessed for response during treatment.|||percentage of participants|||Number
1237833|NCT00601900|Secondary|6 Month Progression-Free Survival Rate|The 6 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 6 months after registration into the study.|At 6 months|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.|||percentage of participants||95% Confidence Interval|Number
1237834|NCT00601900|Secondary|12 Month Progression Free Survival Rate|The 12 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 12 months after registration into the study.|At 12 months|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.|||percentage of participants||95% Confidence Interval|Number
1237835|NCT00601900|Primary|Progression-free Survival|The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions.|From randomization until disease progression or death whichever occurs first, assessed up to 5 years|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.|||months||95% Confidence Interval|Median
1237836|NCT00601835|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.|Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Chills, Diarrhea, Fever (temperature), Headache, Malaise, Muscle weakness, Nausea, Pain in joints, Rash, and Vomiting.|0-14 days post-vaccination|Solicited safety parameters were in all enrolled and vaccinated participants ≥ 60 years of age and one third of participants 11 to 59 years of age. A subset of the intend-to-treat population.|||Participants|||Number
1237837|NCT00601835|Secondary|Post-vaccination Geometric Mean Titer (GMT) to Tetanus and Diphtheria in Participants ≥ 60 Years Vaccinated With Canadian-manufactured or US-manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.||28 Days post-vaccination|Geometric mean titers were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population|||Titers||95% Confidence Interval|Geometric Mean
1237838|NCT00601835|Primary|Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.|Seroprotection and booster responses for both tetanus and diphtheria were considered to be an antibody level of ≥ 0.10 IU/mL 28 days post-vaccination with either the Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine or the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in participants ≥ 60 years of age.|28 Days post-vaccination|Seroprotection and Booster Responses to Tetanus and Diphtheria were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population.|||Percentage of participants|||Number
1237839|NCT00601796|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Criteria (CTAE-3),Version 3.0 (www.ctep.cancer.gov). Particular attention will assess the presence of symptomatic lymphadenopathy or any local skin / soft tissue reaction at the vaccine site. Blood tests for ANA and rheumatoid factor will be performed on any patient who develops evidence of autoimmune phenomena.|3 years|All participants|||participants|||Number
1237840|NCT00601796|Secondary|Median Overall Survival (OS)|Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.|3 years|All participants|||months||95% Confidence Interval|Median
1237841|NCT00601796|Secondary|Median Time to Progression (TTP)|"Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier."|3 years|All participants|||months||95% Confidence Interval|Median
1237842|NCT00601796|Primary|Number of Evaluable Participants With Tumor Response|Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.|3 years|14 participants with evaluable PBMCs|||participants|||Number
1238785|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Pulmonary’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1237843|NCT00601731|Secondary|GMTs in Subjects Within Each Site and in Age-Matched Control Subjects|The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.|At 40 and 60 months of age|The analysis was done on MITT population|||Titers||95% Confidence Interval|Geometric Mean
1237844|NCT00601731|Secondary|Percentage of Subjects With hSBA ≥1:4|Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.|At 40 and 60 months of age|The analysis was done on MITT population|||Percentages of subjects||95% Confidence Interval|Number
1237845|NCT00601731|Primary|Percentage of Subjects With hSBA ≥1:8|Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.|At 40 and 60 months of age|Immunogenicity was evaluated in the Modified Intent To Treat (MITT) population that included subjects who provided at least one evaluable blood sample. Thus, the difference in the number of subjects entered here versus the number of subjects in the participant flow and baseline characteristics (i.e., enrolled subjects) module.|||Percentages of subjects||95% Confidence Interval|Number
1237846|NCT00601718|Primary|Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment||1-3 weeks post end of treatment||||Participants|||Count of Participants
1237847|NCT00601718|Primary|Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy||3-5 weeks post end of treatment||||Participants|||Count of Participants
1237848|NCT00601718|Primary|Safety and Toxicity According to CTCAE v3.0|Common dose limiting toxicities.|3-5 weeks post end of treatment||||Participants|||Count of Participants
1237849|NCT00601718|Primary|Maximum Tolerated Dose of Vorinostat||28 days post last dose of study drug||||mg twice daily X 5 days|||Number
1237850|NCT00601640|Secondary|Change in Histologic Score Diagnosis and Treatment Group|Change scores were computed by subtracting baseline histologic score from End of Study histologic score. Slides were formalin fixed. Histologic Score has been developed by this research group over the course of Grant (reference below). A standardized form captures data on the following criteria: basal or suprabasilar pleomorphism (atypia); inflammation; hyperkeratosis; parakeratosis. The atypia and inflammation were rated as: none (0), mild to moderate(1), and severe (2). The remaining criteria were rated as present (1) or absent (0). Histologic Scores were computed by adding together the codes for the histologic criteria. Higher scores reflected higher level of epidermal /dermal damage.|3 months||||units on a scale||Standard Error|Mean
1237851|NCT00601640|Primary|Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months|Adverse events were compared across three treatment groups by severity determined by the clinician. All adverse events were resolved by the end of follow up.|3 months||||participants|||Number
1237852|NCT00601640|Primary|Changes in Putrescine Over 3 Months|Putrescine is measured in nmole/g skin per biopsy. Baseline and End of Study biopsies were measured and the change was produced by subtracting baseline levels from End of Study levels. There was one baseline biopsy and one End of Study biopsy per participant.|3 months||||nmol/g skin||Standard Error|Mean
1237853|NCT00601627|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of survival time will be estimated using the method of Kaplan-Meier.|baseline to 2 years|All patients were included in the analysis.|||months||95% Confidence Interval|Median
1237854|NCT00601627|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.|baseline to 2 years|Too few patients reported a confirmed response to provide meaningful information into the duration of response.||||||
1237855|NCT00601627|Secondary|Confirmed Response Rate|"A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.~A complete response is defined as the disappearance of all target and non-target lesions.~A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion from baseline.~Confirmed tumor response will be evaluated using the first 6 cycles of treatment."|baseline to 2 years|All patients were analyzed for this endpoint.|||rate of confirmed response||95% Confidence Interval|Number
1237856|NCT00601627|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the time from registration to the earliest documented evidence of disease progression.|baseline to 2 years|All patients were evaluable for this endpoint.|||months||95% Confidence Interval|Median
1237857|NCT00601627|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|baseline to 2 years|All patients were evaluable for this endpoint.|||months||95% Confidence Interval|Median
1237858|NCT00601627|Primary|One Year Survival Rate|The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method.|Baseline to 12 months|All patients were evaluable for this endpoint.|||proportion of patients||95% Confidence Interval|Number
1237859|NCT00601523|Secondary|Patient Rating of Convenience of Treatment Dosing|Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)|||participants|||Number
1238311|NCT00596934|Secondary|Liver Function Test: Alanine Aminotransferase (ALT) Values at 12 Months|ALT value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||IU/L||Standard Deviation|Mean
1237860|NCT00601523|Secondary|Patient Preference Regarding Treatment Dosing|Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)|||participants|||Number
1237861|NCT00601523|Primary|Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)|||Percentage of participants|||Number
1237862|NCT00601523|Secondary|Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients|Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment|Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80 (patients from 248.524) or week 72 (patients from 248.636)|||Patients|||Number
1237863|NCT00601523|Secondary|L-Dopa Dose: Change From OL Baseline|Change from open-label baseline in Levodopa dose|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and with L-Dopa at OL baseline and at week 80 (patients from 248.524) or week 72 (patients from 248.636)|||Patients|||Number
1237864|NCT00601523|Secondary|Number of Patients Introducing L-Dopa Medication in OL Trial|Number of patients requiring Levodopa supplementation during the study|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from FAS|||Patients|||Number
1237865|NCT00601523|Secondary|Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline|PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD.|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for PFS-16 at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
1237866|NCT00601523|Secondary|Response in Patient Global Impression of Improvement (PGI-I)|"Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders"|OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)|Patients from FAS and who had values for for PGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)|||Patients|||Number
1237867|NCT00601523|Secondary|Response in Clinical Global Impression of Improvement (CGI-I)|"Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders"|OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)|Patients from FAS and who had values for for CGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)|||Patients|||Number
1237868|NCT00601523|Secondary|UPDRS III Total Score: Change From OL Baseline|UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
1237869|NCT00601523|Secondary|UPDRS II Total Score: Change From OL Baseline|UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS II at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
1237870|NCT00601523|Secondary|UPDRS I Total Score: Change From OL Baseline|UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS I at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
1237871|NCT00601523|Secondary|Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)|A response means an improvement of >=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Patients|||Number
1237872|NCT00601523|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline|UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
1237873|NCT00601458|Secondary|Time to First Request of PCA Hydromorphone|Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.|First 24 hours following surgery||||Hours||Inter-Quartile Range|Median
1238351|NCT00596622|Secondary|Young Mania Rating Scale|Gold standard scale to measure mania, Range 0 - 60; 12 - 15 mild mania; 15 - 20 moderate mania; >20 severe mania|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1237874|NCT00601458|Primary|Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery|Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.|First 24 hours following surgery||||milligrams||Inter-Quartile Range|Geometric Mean
1237875|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.|||participants|||Number
1237876|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy by Gender.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.|||participants|||Number
1237877|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.|||participants|||Number
1237878|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.|||participants|||Number
1237879|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.|To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1237880|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1237881|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.|To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1237882|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1237883|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1237884|NCT00601419|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||events|||Number
1237885|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1237886|NCT00601367|Primary|Frequency of Adverse Events||28 weeks||||participants with any adverse event|||Number
1237887|NCT00601354|Other Pre-specified|Weeks of Adherence to Orlistat||Number of adherent weeks over 1 year study|Intent to treat|||week of adherence to orlistat||Standard Deviation|Mean
1237888|NCT00601354|Secondary|Binge Frequency|frequency of objective binge days over prior 28 days|3 months: Measured from pre to post treatment|Intent to treat|||% change objective binge days||Standard Deviation|Mean
1237890|NCT00601250|Secondary|2 Hour Post−Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24|This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)|||mg/dL||Standard Error|Least Squares Mean
1237891|NCT00601250|Secondary|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)|||mg/dL||Standard Error|Mean
1237892|NCT00601250|Secondary|Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237893|NCT00601250|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237894|NCT00601250|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237895|NCT00601250|Secondary|Percentage of Patients With HbA1c < 7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237896|NCT00601250|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24.|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1237897|NCT00601250|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1237898|NCT00601250|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1237899|NCT00601250|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1237900|NCT00601250|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1237901|NCT00601250|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1237902|NCT00601250|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1237903|NCT00601250|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1238090|NCT00599924|Secondary|Tmax of Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
1237904|NCT00601250|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1237905|NCT00601172|Secondary|Time to First Emetic Event|Time to first emetic event was defined as the length of time from initiation of oxaliplatin until the time of first emetic event. Participants withdrawing prematurely from the study without having experienced an emetic event were assumed to have done so and the time of emetic event was set to 0 hours. The first quartile for time to emetic event was evaluated when 25th percentile of participants of MITT population reported emetic event. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 25th percentile of participants reported emetic event at the end of the 120 hour time period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA).|0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Hours||Inter-Quartile Range|Median
1237906|NCT00601172|Secondary|Time to First Anti-emetic Rescue Medication|Time to first rescue medication was defined as the length of time from initiation of oxaliplatin till the first reported use of a rescue medication. Participants withdrawing prematurely during the 120 hour assessment period without having received a rescue medication were assumed to have done so and the time of rescue medication was set to 0 hours. The first quartile for time to use of anti-emetic rescue medication was evaluated when 25th percentile of participants of MITT population reported use of anti-emetic rescue medication. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 25th percentile of participants reported use of anti-emetic rescue medication at the end of the 120 hour time period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA).|0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Hours||Inter-Quartile Range|Median
1237907|NCT00601172|Secondary|Evaluation of Vital Signs: Mean Heart Rate|Vital sign included heart rate which was recorded at Screening, on Day 1 of each cycle immediately before start of the investigational product infusion, at the completion of the infusion, and immediately after the end of the oxaliplatin infusion, then again at each end of cycle visit. Mean heart rate is presented.|Up to End of Cycle for 6 cycles, an average of 24 days per cycle|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats/minute||Standard Deviation|Mean
1237908|NCT00601172|Secondary|Evaluation of Vital Signs: Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Vital signs assessment included DBP and SBP. SBP and DBP were recorded at Screening, on Day 1 of each cycle immediately before start of the investigational product infusion, at the completion of the infusion, and immediately after the end of the oxaliplatin infusion, then again at each end of cycle visit. Mean SBP and DBP are presented.|Up to End of Cycle for 6 cycles, an average of 24 days per cycle|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1237909|NCT00601172|Secondary|Number of Participants With Clinical Chemistry Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4|Grade shifts from Baseline were assessed as shift from any Grade to Grade 3 or Grade 4 in any cycle. Toxicities were graded according to the NCI-CTCAE, version 3.0. Grade refers to the severity of the toxicity. The NCI-CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. It was assessed on Baseline (Day 1), during Day 6-10 and end of cycle. Clinical chemistry parameters assessed were alanine amino transferase (ALT), aspartate amino transferase (AST), chloride, glucose, potassium, sodium and total bilirubin. Data has been presented for the number of participants with chemistry toxicity grade shifts from Baseline to toxicity grade 3 and 4 for all cycles in a consolidated format.|Up to Day 24|Safety Population.|||Participants|||Count of Participants
1237910|NCT00601172|Secondary|Number of Participants With Hematology Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4|Grade shifts from Baseline were assessed as shift from any Grade to Grade 3 or Grade 4 in any cycle. Toxicities were graded according to the National Cancer Institute common toxicity criteria for adverse events (NCI-CTCAE), version 3.0. Grade refers to the severity of the toxicity. The NCI-CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. It was assessed on Baseline (Day 1), during Day 6-10 and end of cycle. Hematology parameters assessed were hematocrit, hemoglobin, platelet count, total neutrophils and white blood cell count. Data has been presented for the number of participants with hematology toxicity grade shifts from Baseline to toxicity grade 3 and 4 for all cycles in a consolidated format.|Baseline (Day 1) to Day 24|Safety Population.|||Participants|||Count of Participants
1237911|NCT00601172|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.|Up to 35 days|Safety Population which comprised of all participants who were randomized, and received any investigational product.|||Participants|||Count of Participants
1238091|NCT00599924|Secondary|Cmax of Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
1237912|NCT00601172|Secondary|Single-dose Pharmacokinetic Parameters: Volume of Distribution (Vdss) for Casopitant|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. Vdss for casopitant is presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1237913|NCT00601172|Secondary|Single-dose Pharmacokinetic Parameters: Clearance (CL) for Casopitant|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. CL for casopitant is presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
1237914|NCT00601172|Secondary|Single-dose Pharmacokinetic Parameters: Time to Maximum Observed Drug Concentration (Tmax) and Observed Elimination Half-life (t1/2) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. Tmax and t1/2 for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK parameter population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
1237915|NCT00601172|Secondary|Single-dose Pharmacokinetic Parameters: Maximum Observed Drug Concentration (Cmax) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the electronic case report form (eCRF). Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. (Cmax) for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK Parameter population. Only those participants available at the specified time points were analyzed.|||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1237916|NCT00601172|Secondary|Single-dose Pharmacokinetic (PK) Parameters: Area Under the Curve (AUC) 0 to Infinity (0-∞), AUC 0 to t (0-t) and AUC 0 to 24 Hours (0-24) for Casopitant; AUC (0-t) and AUC (0-24) for Metabolites GSK525060, GSK517142 and GSK631832|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the electronic case report form (eCRF). Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. AUC(0-∞), AUC(0-t), AUC(0-24) for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK parameter population: All participants who consented to PK sampling, who were randomized to IV casopitant and for whom a PK sample was obtained and analyzed, and from whom sufficient data was available to calculate casopitant PK parameters on an as-treated basis. Only those participants with data available at indicated time points were analyzed.|||Hour*nanogram/milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1237917|NCT00601172|Secondary|Severity of Nausea in the Overall, Acute, and Delayed Phases of Cycle 1 Assessed by a Categorical Scale|Participants were asked to rate the level of nausea he/she experienced over the previous (24 hours for a period of 120 hours following the administration of MEC), by placing a vertical mark on a VAS. The severity of nausea and was calculated by using a 0 - 100 VAS where 0 = No Nausea and 100 = Nausea as bad as it can be. The categorical scale assessed the participants severity of his/her nausea using the following: mild: Queasiness/upset stomach that is manageable and minimally (if at all) affects daily activities, moderate: increased queasiness, sometimes with the feeling of having to vomit/throw up (but not vomiting), that has significant negative effect on the daily activities (for example, being unable to work, eat and drink, prepare food, care for children or others) and severe: feeling sick and vomiting or feeling like you are going to vomit, and unable to perform most daily activities. Higher scores indicated worst outcome.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Participants|||Count of Participants
1237927|NCT00601172|Secondary|Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1|Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participants who achieved a complete response in the delayed phase of Cycle 1 are presented.|24 to 120 hours (delayed phase) in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237918|NCT00601172|Secondary|Percentage of Participants Whose Daily Life Activities Were Impacted in the Overall Phase of Cycle 1, Assessed by Functional Living Index-Emesis (FLIE) Questionnaire|FLIE questionnaire specifically addresses the impact of nausea and vomiting on daily activities (physical, social and emotional function, ability to enjoy meals). It consists of 18 items with questions divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). Each item is scored on a VAS with 7 hatch marks. The scale is anchored at 1 (Not at all) and 7 (A great deal). For questions 1,2,4,5,7,8-10,12-14,16 and 17 the final score was calculated by subtracting the initial score from 100 for questions 3,6,11,15 and 18 the final score was the one provided in the dataset. The score for the nausea domain: ([sum of nausea item scores] ÷ [Number of items answered] x 9) and for vomiting domain: ([sum of vomiting item scores] ÷ [Number of items answered] x 9). The total score was the sum of the nausea and vomiting domain scores. Higher scores indicate less impairment on daily life as a result of nausea or vomiting.|0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237919|NCT00601172|Secondary|Percentage of Participants Who Achieved Total Control, Defined as Complete Responders Who Had no Nausea|Total control was defined as no vomiting/retching, no use of rescue medication and no nausea. Percentage of participants who achieved total control or complete responders with no nausea are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237920|NCT00601172|Secondary|Percentage of Participants Who Achieved Complete Protection Defined as Complete Responders With no Significant Nausea|Complete protection was defined as no vomiting/retching, no use of rescue medication and no significant nausea. Percentage of participants who achieved complete protection or complete responders with no significant nausea are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237921|NCT00601172|Secondary|Percentage of Participants Who Reported Nausea, Defined as a Maximum Score of >= 5 mm on the VAS|VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported nausea, defined as a maximum score of >= 5 mm on the VAS are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237922|NCT00601172|Secondary|Percentage of Participants Who Reported Significant Nausea, Defined as a Maximum Score >= 25 mm on the VAS|VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported significant nausea, defined as a maximum score >= 25 mm on the VAS are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237923|NCT00601172|Secondary|Percentage of Participants Who Vomited and/or Retched|Vomiting was defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching was defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit, that is not productive of gastrointestinal contents (also known as dry heaves). If a participant took rescue medication but there was no evidence of vomiting or retching, then the participant was considered as not having vomited. Percentage of participants who vomited and/or retched during the first 120 hours of the first cycle of chemotherapy are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237924|NCT00601172|Secondary|Percentage of Participants Who Received Rescue Medication|Anti-emetic rescue medication was defined as medication that was administered specifically for the treatment of nausea and/or emesis during Days 1-6 of each cycle. The choice of rescue anti-emetic medication was left to the discretion of the investigator. Participants who required antiemetic rescue medication(s) during the 120-hour assessment period were considered treatment failures for that cycle. Percentage of participants who received rescue medication are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237925|NCT00601172|Secondary|Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS)|VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
1237926|NCT00601172|Secondary|Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2|Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase of Cycle 2 are presented.|0 to 120 hours in the second cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237937|NCT00600938|Secondary|Extension Study: The Cardiac Iron Concentration From T2* Values|Cardiac iron concentration (derived from T2* values) at baseline, Months 6, 12, 18 and 24 were summarized by descriptive statistics. The absolute change from baseline at Months 6, 12, 18 and 24 were also summarized by treatment group. Lliver iron concentration is expressed in units (mg of iron / g of liver tissue dry weight (dw)|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase|||mg Fe/g dw||Standard Deviation|Mean
1237928|NCT00601172|Secondary|Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1|Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participants who achieved a complete response in the acute phase of Cycle 1 are presented.|0 to 24 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
1237929|NCT00601172|Primary|Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen|Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase (0-120 hours) are presented.|0 to 120 hours in the first cycle of chemotherapy|Modified Intent-to-Treat Population (mITT) comprised of all participants who were randomized, received any investigational product and had oxaliplatin administered.|||Percentage of participants|||Number
1237930|NCT00601146|Primary|To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.|In this study, patients will under annual low-dose chest CT screening. The total number of lung cancer detected through the screening will be recorded|3 years|Enrolled patients who underwent low-dose CCT screening- number of lung cancer diagnosed|||participants|||Number
1237931|NCT00601107|Secondary|Percentage of Participants With Static Physician’s Global Assessment (PGA) Score of Clear or Almost Clear at Week 12, 24 or Early Termination|Static PGA of psoriasis is scored on a 5-point scale (0 = clear to 4 = severe), reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. Clear (erythema: no, scale: no, induration: no thickness); Almost Clear (erythema: light pink, scale: fine scale, induration: barely palpable); Mild (erythema: light red, scale: coarse scale on most lesions, induration: slight but visible elevation, indistinct edges); Moderate (erythema: red, scale: coarse adherent scale predominates, induration: moderate elevation with edges); and Severe (erythema: dark red to purple, scale: thickened adherent scale, induration: marked thickness distinct and pronounced edges). Percentage of participants with static PGA score of clear or almost clear are reported.|Week 12 or Early Termination, Week 24 or Early Termination|FAS included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.|||percentage of participants|||Number
1237932|NCT00601107|Secondary|Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination|PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].|Week 24 or Early Termination|FAS included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.|||percentage of participants|||Number
1237933|NCT00601107|Primary|Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination|PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].|Week 12 or Early Termination|The Full Analysis Set (FAS) included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.|||percentage of participants|||Number
1237934|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Tmax)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, time to reach maximum plasma concentration (Tmax)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).|||(h)||Inter-Quartile Range|Median
1237935|NCT00600938|Secondary|Extension Study: Change in Serum Ferritin From Baseline by Month|Serum ferritin values was summarized by descriptive statistics. Absolute value and the absolute change from baseline in serum ferritin by month was provided by treatment group.|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase|||ug/L||Standard Deviation|Mean
1237936|NCT00600938|Secondary|Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24|Results of liver iron content (LIC) measurements by MRI was summarized by descriptive statistics. The absolute value and the absolute change from baseline in LIC at Months 6, 12, 18 and 24 were provided by treatment group.|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase|||mg Fe/g dw||Standard Deviation|Mean
1237938|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI)|Cardiac function endpoints (LVMI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites|||gram/m^2||Standard Deviation|Mean
1237939|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)|Cardiac function endpoint (LVEDVI ) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites|||mL/m^2||Standard Deviation|Mean
1237940|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI)|Cardiac function endpoints (LVESVI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites.|||mL/m^2||Standard Deviation|Mean
1237941|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF)|Cardiac function endpoints (LVEF) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites.|||Percent||Standard Deviation|Mean
1237942|NCT00600938|Secondary|Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment|The measured T2* values, the ratio (post-baseline / baseline T2*) at Month 6, 12, 18 and 24 was summarized for FAS population along with two-sided 95% CIs. The geometric means of the ratio was presented for all treatment groups|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase.|||Ratio||95% Confidence Interval|Geometric Mean
1237943|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. For trough concentration assessments, a 2-mL blood sample was to be taken on arrival at the study site, i.e. prior to the patient receiving the daily deferasirox dose (pre-dose blood sample). A second 2-mL blood sample was to be taken 2 hours later (post-dose sample). At all other visits (Visits 3 - 14), a pre-dose sample was to be taken. For PK profile assessments, 3 blood samples were taken after 1, 2, and 4 hours post-dose in addition to the 2-mL pre-dose|Month 1 and month 2 (pre-dose, 1,2 and 4 hours post-dose)|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).|||(umol/L)||Standard Deviation|Mean
1237944|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Cmax)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, maximum plasma concentration (Cmax)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).|||umol/L||Standard Deviation|Mean
1237945|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, area under the plasma concentration-time curve for a dosing interval (AUCtau)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).|||(h.ng/mL)||Standard Deviation|Mean
1237946|NCT00600938|Secondary|Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period.|Number of patients with adverse events, serious adverse events and death|12 Month|Safety Set (SS) consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. Treatment received is defined as first study drug administered|||Participants|||Number
1237947|NCT00600938|Secondary|Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine|The number of patients withdrawn from the study due to LVEF <50%, T2* <6 ms or significant decreases in T2* ≥ 33% from baseline was provided per treatment group.|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Participants|||Number
1237948|NCT00600938|Secondary|Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI)|An absolute change from baseline in LVMI after 6, and 12 months treatment with deferasirox and DFO was summarized|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||gram/m^2||Standard Deviation|Mean
1237949|NCT00600938|Secondary|Core Study: Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)|An absolute change from baseline in LVEDVI after 6, and 12 months treatment with deferasirox and DFO was summarized|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Percent||Standard Deviation|Mean
1237950|NCT00600938|Secondary|Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI)|An absolute change from baseline in LVESVI after 6 and 12 months treatment with deferasirox and DFO was summarized. Changes in cardiovascular magnetic resonance (CMR) measured left ventricular end systolic after 6 and 12 months treatment. Left ventricular (LV) end-systolic volume indexed to body surface area (ESVI) is a simple yet powerful echocardiographic marker of LV remodeling that can be measured easily. Left ventricular (LV) end-systolic volume (ESV) has been shown to be an important determinant of survival after myocardial infarction (MI)|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Milliliter||Standard Deviation|Mean
1237951|NCT00600938|Secondary|Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment|Summary statistics of T2* ratio Month 6/baseline|6 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Ratio||95% Confidence Interval|Geometric Mean
1237952|NCT00600938|Secondary|Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)|An absolute change from baseline in LVEF after 6 months treatment with deferasirox and DFO was summarized|6 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Percent||Standard Deviation|Mean
1237953|NCT00600938|Secondary|Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)|An absolute change from baseline in LVEF after 12 months treatment with deferasirox and compared to.DFO was tested using an analysis of covariance model including baseline left ventricular ejection fraction (LVEF) as a covariate.|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations.|||Percent||Standard Error|Least Squares Mean
1237954|NCT00600938|Primary|Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment|Non- inferiority in efficacy of deferasirox compared to deferoxamine (DFO) in treating cardiac iron overload as measured by T2*. A non-inferiority margin of 0.9 (90%) was applied. Due to limitations in performing heart biopsies, T2* (T2 star), a Magnetic Resonance (MR) relaxation parameter expressed in milliseconds, as is an important tool to noninvasively quantify cardiac iron concentration. Studies have shown that myocardial T2* evaluations may predict cardiac events, e.g., impaired (<56%) left ventricular ejection fraction (LVEF) is prevalent among patients with low T2*: found in 62% of patients with T2*<8 ms; 20% with T2* of 8-12 ms; and in 5% with T2* >12 ms (Tanner 2006)|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations.|||Millisecond||95% Confidence Interval|Geometric Mean
1237955|NCT00600886|Secondary|Summary of Prolactin Levels After Crossover|Prolactin (PRL) levels. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Extension baseline was defined as last measurement prior to the start of crossover treatment.|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||μg/L||Standard Deviation|Mean
1237956|NCT00600886|Secondary|Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover|AcroQoL total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Total scores range from 0 to 100. Higher scores represent better quality of life.|Extension baseline, months 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||scores on a scale||Standard Deviation|Mean
1237985|NCT00600821|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile in Whole Blood|RNA expression profiles of genes which were associated with tumor growth, angiogenesis and metastases were collected and correlated with efficacy.|Baseline, C1 D1, C1 D15, C2 D1, C3 D1, C4 D1 and C5 D1|Data was not generated but sample was collected for banking and moved to a separate exploratory research database for future research.||||||
1237957|NCT00600886|Secondary|Ring Size After Crossover|Ring size (based on jeweler’s finger gauge). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). BL = baseline, LH = left hand, RH = right hand, CO = crossover|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received. In the extension baseline, no participant had ring size on their right hand measured at the 5th digit, hence no data.|||ring size||Standard Deviation|Mean
1237958|NCT00600886|Secondary|Severity Scores of Acromegaly Symptoms After Crossover|"Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia).~Symptoms were scored from 0 (no symptom) to 4 (very severe). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over)."|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||scores on a scale||Standard Deviation|Mean
1237959|NCT00600886|Secondary|Change From Extension Baseline in Tumor Volume After Crossover|"Percentage change from extension baseline in tumor volume (assessed by pituitary MRI).~Extension baseline was defined as last assessment prior to the administration of the new treatment after crossover. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over)."|Extension baseline, months 6, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||mm^3||Standard Deviation|Mean
1237960|NCT00600886|Secondary|Summary of Mean GH Values After Crossover|Mean GH levels (based on a 5-point profile over 2 hours). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).|Extension baseline, months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||μg/L||Standard Deviation|Mean
1237961|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1 After Crossover|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||Percentage of participants||95% Confidence Interval|Number
1237962|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover|Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||Percentage of participants||95% Confidence Interval|Number
1237963|NCT00600886|Secondary|Change From Baseline in Tumor Volume|Percentage change from baseline in tumor volume (assessed by pituitary MRI). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, months 6, 12, 19, 25|Full Analysis Set: All patients who were randomized into the study.|||mm^3||Standard Deviation|Mean
1237964|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the FAS. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.|||Percentage of participants||95% Confidence Interval|Number
1237965|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).~Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the Full Analysis Set. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover."|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.|||Percentage of participants||95% Confidence Interval|Number
1238004|NCT00600756|Secondary|Number of Participants Using Antidepressants at Month 12 in the ITT Population|"The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup N06-Antidepressants."|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
1237966|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover|Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|"Crossover Analysis Set (CAS): All patients whose first dose in the extension is different from the first dose in the core.~Patients were analyzed according to the crossover treatment received."|||Percentage of participants||95% Confidence Interval|Number
1237967|NCT00600886|Secondary|Octreotide Trough Concentrations by Incident Dose|Octreotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.|Months 1 - 12|PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 30 mg dose in Months 1, 2 and 3, hence no data.|||ng/mL||Standard Deviation|Mean
1237968|NCT00600886|Secondary|Pasireotide Trough Concentrations by Incident Dose|"Pasireotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.~5 patients with evaluable PK data in the pasireotide arm received erroneously 20 mg pasireotide LAR at baseline."|Months 1 - 12|PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 60 mg dose in Months 1, 2 and 3, hence no data.|||ng/mL||Standard Deviation|Mean
1237969|NCT00600886|Secondary|Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)|"The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status.~Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included)."|Up to 26 months|Full Analysis Set: All patients who were randomized into the study.|||Weeks||95% Confidence Interval|Median
1237970|NCT00600886|Secondary|Summary of Prolactin Levels|Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.|||μg/L||Standard Deviation|Mean
1237971|NCT00600886|Secondary|Health-related Quality-of-life as Measured by the AcroQoL Questionnaire|Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.|||Score on a scale||Standard Deviation|Mean
1237972|NCT00600886|Secondary|Ring Size|Ring size (based on jeweler’s finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.|||ring zize||Standard Deviation|Mean
1237973|NCT00600886|Secondary|Severity Scores of Acromegaly Symptoms|Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.|||scores on a scale||Standard Deviation|Mean
1237974|NCT00600886|Secondary|Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )|Time to first response for patients achieving a reduction of mean GH level to < 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Up to 26 months|Full Analysis Set: All patients who were randomized into the study.|||Weeks||95% Confidence Interval|Median
1237975|NCT00600886|Secondary|Summary of Mean GH Values|Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.|||μg/L||Standard Deviation|Mean
1238005|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population||12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Days||Standard Deviation|Mean
1237976|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.~Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core & ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.)"|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.|||Percentage of participants||95% Confidence Interval|Number
1237977|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.|12 Months|Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing IGF-1 levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as nonresponders.|||Percentage of participants||95% Confidence Interval|Number
1237978|NCT00600886|Secondary|Change From Baseline in Tumor Volume at 12 Months|Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.|Baseline, 12 Months|Full Analysis Set (FAS): All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.|||mm^3||Standard Deviation|Mean
1237979|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).~Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated."|12 Months|FAS: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as non-responders.|||Percentage of participants||95% Confidence Interval|Number
1237980|NCT00600886|Primary|Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1|"Percentage of participants with a reduction of mean GH levels to <2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.~Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated."|12 months|Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH and/or IGF-1 levels at M12 were imputed using data obtained at or after M6 by the last observation carried forward method; otherwise, Pts were considered as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
1237981|NCT00600821|Other Pre-specified|Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype|UGT1A1 an enzyme of the glucuronidation pathway that transforms small lipophilic molecules, such as steroids, bilirubin, hormones, and drugs, into water-soluble, excretable metabolites.|Baseline (Day 1 of Cycle 1)|Data was reported in listings but not summarized due to statistical constraints.||||||
1237982|NCT00600821|Secondary|Plasma Concentration of Soluble Proteins|Plasma concentrations of soluble proteins (soluble- stem-cell factor receptor (sKIT) vascular endothelial growth factor [VEGF], and vascular endothelial growth factor receptor-2 [VEGFR2], VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Baseline, C1D1, C1D15, C2D1, C3D1, C4D1, C5D1, C7D1, C9D1 and C11D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.|||Picogram/mL (pg/mL)||Standard Deviation|Mean
1237983|NCT00600821|Secondary|Circulating Endothelial Cells (CEC) in Blood|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.|Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.|||Flourescent Intensity Unit (FIU)||Standard Deviation|Mean
1237984|NCT00600821|Secondary|Circulating Endothelial Cells (CEC) in Blood: Total CEC|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.|Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.|||Cells/milliliter (cells/mL)||Standard Deviation|Mean
1237986|NCT00600821|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of every cycle then every 3 weeks until final study visit (up to 2.75 years)|ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
1237987|NCT00600821|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhoea, and financial difficulties). Most questions used 4- point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years)|ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
1237988|NCT00600821|Secondary|Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1|||||||
1237989|NCT00600821|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).|||Months||95% Confidence Interval|Median
1237990|NCT00600821|Secondary|Percentage of Participants With Objective Response (OR)|OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all lesions (target and/or non target) and no appearance of new lesions. PR: at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, without progression of non target lesions and no appearance of new lesions.|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1237991|NCT00600821|Secondary|Overall Survival (OS)|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the first randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1237992|NCT00600821|Primary|Progression Free Survival (PFS)|"Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1237993|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.|Month 12|"Safety population at Month 12 is presented. Quetiapine XR: Out of 231 evaluable men, 111 were missing individual AE “Sexual Dysfunction” data”.~Risperidone: Out of 231 evaluable men, 106 were missing individual AE “Sexual Dysfunction” data”."|||Participants|||Number
1238027|NCT00600704|Primary|Mean Number of Packed Red Cells Units Transfused During Hospital Stay||20 months|Patients between ages 18-85 undergoing elective cardiac surgery under cardiopulmonary bypass|||packed red cells units|Participants|95% Confidence Interval|Mean
1237994|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.|Month 12|"Safety population at Month 12 is presented. Quetiapine XR: Out of 160 evaluable women, 73 were missing individual AE “Hyperprolactinaemia” data.~Risperidone: Out of 171 evaluable women, 74 were missing individual AE “Hyperprolactinaemia” data”."|||Participants|||Number
1237995|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
1237996|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population|The normal range for men is 0 to 14, and for women is 0 to 24.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||ng/mL||Standard Deviation|Mean
1237997|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
1237998|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population|Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Events|||Number
1237999|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
1238000|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
1238001|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
1238002|NCT00600756|Secondary|The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population||12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
1238003|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population|Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
1238028|NCT00600613|Primary|"Number of Participants Eligible for Cone Beam Tumor Localization"|Assess the feasibility of using a new imaging technique called “cone beam imaging” to localize a liver tumor immediately prior to external beam radiotherapy.|Up to 2 hours||||participants|||Number
1238006|NCT00600756|Secondary|Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population|Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.|Month 12|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
1238007|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population|All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
1238008|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population|"Workers and students are defined from the modified vocational status index excluding subjects Retired or Unemployed, whether or not expected to work."|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Days||Standard Deviation|Mean
1238009|NCT00600756|Secondary|To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State|Stable State was defined as having the same status in occupational and residential status as at Baseline.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants with stable state|||Number
1238010|NCT00600756|Secondary|Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.|The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
1238011|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population|Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.|12 months|The Reported population is participants who showed relapse over time, from baseline to Month 12.|||Participants|||Number
1238012|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
1238013|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score|For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0).|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Deviation|Mean
1238014|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).|For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
1238015|NCT00600756|Secondary|The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population|Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
1238016|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
1238017|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
1238018|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
1238019|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
1238020|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
1238021|NCT00600756|Secondary|Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population|The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.|Baseline and Month 12|For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).|||Scores on a scale||Standard Error|Least Squares Mean
1238022|NCT00600756|Secondary|Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population|The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.|Baseline and Month 12|For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).|||Scores on a scale||Standard Error|Least Squares Mean
1238023|NCT00600756|Primary|Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score|The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)|6 months|For Per Protocol at Month 6 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (169) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (160).|||Participants|||Number
1238024|NCT00600743|Secondary|Sickness Report|"Response to question How sick do you feel measured on a 150 mm line anchored by none at all (0 mm left end) and extremely (150 mm right end)"|25-30 min after drug or placebo||||mm||Standard Error|Mean
1238025|NCT00600743|Secondary|Fullness Rating|"rating of How full do you feel by marking the feeling on a 150 mm line anchored at one end from 0 (not at all) to 150 (most imaginable)."|25-30 min after taking drug||||mm||Standard Error|Mean
1238026|NCT00600743|Primary|Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions|Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions|25-30 min after taking drug|Subjects had to complete all trials of the protocol successfully|||grams||Standard Error|Mean
1238030|NCT00600353|Primary|Overall Emetic Response|Clinical responses were summarized using frequencies and percentages by phase, disease group, and overall. To compute emetic response by phase, the previously defined criteria were applied to each day of the three phases independently. The worst response was used to represent the response in each of these phases and overall emetic response. Overall emetic response was computed by applying the same definitions of emetic response to the entire study period.|At leaset 24 hours to more than 72 hours after chemotherapy||||Participants|||Count of Participants
1238031|NCT00600353|Primary|Overall Emetic Response: Extended|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) – 0 emetic episodes, no rescue medications. Major Emetic Response (MR) – 0 to 2 emetic episodes within 24 hour period with or without rescue medications.~Minor Emetic Response (mR) – 3 to 5 emetic episodes within 24 hour period with or without rescue medications.~Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) – maximum NVS ≤ 5."|72 hours after chemotherapy||||Participants|||Count of Participants
1238032|NCT00600353|Primary|Overall Emetic Response: Delayed|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) – 0 emetic episodes, no rescue medications. Major Emetic Response (MR) – 0 to 2 emetic episodes within 24 hour period with or without rescue medications.~Minor Emetic Response (mR) – 3 to 5 emetic episodes within 24 hour period with or without rescue medications.~Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) – maximum NVS ≤ 5."|24 to 72 hours after chemotherapy||||Participants|||Count of Participants
1238033|NCT00600353|Primary|Overall Emetic Response: Acute|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) – 0 emetic episodes, no rescue medications. Major Emetic Response (MR) – 0 to 2 emetic episodes within 24 hour period with or without rescue medications.~Minor Emetic Response (mR) – 3 to 5 emetic episodes within 24 hour period with or without rescue medications.~Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) – maximum NVS ≤ 5."|24 hours after chemotherapy||||Participants|||Count of Participants
1238034|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 28|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|Screening (Visit 1) and 24 hours after dosing on Day 28 (Visit 5)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1238035|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 1|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|Screening (Visit 1) and 24 hours after dosing on Day 1 (Visit 2)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1238036|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: 24 Hours After Dosing on Day 1 and Day 28|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), >=24 hours after the first dose (Visit 2) or last dose (Visit 5) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|24 hours after dosing on Day 1 (Visit 2) and on Day 28 (Visit 5)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1238037|NCT00600171|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period|The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. Change from Baseline is calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1238092|NCT00599924|Secondary|T1/2 of SU-012662 (Sunitinib's Metabolite)|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|T1/2 for SU-012662 was not calculated due to short observation time.||||||
1238093|NCT00599924|Secondary|CL/F of SU-012662 (Sunitinib's Metabolite)|CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|CL/F was not calculated for SU-012662.||||||
1238038|NCT00600171|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period|Participants who were symptom free for 24 hours were assessed. Change from Baseline was calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1238039|NCT00600171|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily AM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1238040|NCT00600171|Secondary|Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily PM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1238041|NCT00600171|Secondary|Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Change from Baseline in weighted mean for 24-hour serial FEV1 on Days 1 and Day 28 was assessed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.|Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1238042|NCT00600171|Secondary|Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline in trough FEV1 at the end of the treatment period (23 hours and 24 hours after dosing on Day 28) was analyzed for each stratum (Lower stratum: FEV1 percent predicted, >=40% to <=65%; Upper stratum: FEV1 percent predicted, >=65% to <=90%). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, treatment, and treatment by stratum interaction.|Baseline and Day 28|ITT Population. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used. Only those participants with available data (using LOCF) at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
1238043|NCT00600171|Primary|Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF])|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.|Baseline and Day 28|ITT Population: all participants who were randomized to treatment and received at least one dose of study medication. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used.|||Liters||Standard Error|Least Squares Mean
1238044|NCT00600119|Secondary|Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).|||units on a scale||Standard Deviation|Mean
1238054|NCT00600106|Secondary|Quality of Life - Health Survey|"Quality of life assessed by cardiac symptoms and psychological questionnaires (SF 36 scale - Short Form Health Survey) The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.~Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|12 weeks|SF-36 scale at exit by treatment|||units on a scale||Standard Deviation|Mean
1238045|NCT00600119|Secondary|Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).|||units on a scale||Standard Deviation|Mean
1238046|NCT00600119|Secondary|Change From Baseline in SBMs/Week Across the 28-day Double-blind Period|Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).|||Number of SBMs/week||Standard Deviation|Mean
1238047|NCT00600119|Primary|Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1|Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.|Days 1 through 7|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).|||Number of SBMs/week||Standard Deviation|Mean
1238048|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (Stress Induced ST Segment Depression)|"Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.~In electrocardiography, the ST segment connects the QRS complex and the T wave and has duration of 80 to 120 ms. It should be essentially level with the PR and TP segment. The normal ST segment has a slight upward concavity. Flat, downsloping, or depressed ST segment may indicate coronary ishcemia. Positive treadmill exercise stress test (>1.0 mm horizontal / downsloping or >1.5 upsloping ST segment depression measured 0.08 msec after the J point)."|Exit (12 weeks)|Exercise stress testing at exit (12 weeks) by treatment|||mm||Standard Deviation|Mean
1238049|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (Exercise Induced ST Segment Depression)|"Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.~In electrocardiography, the ST segment connects the QRS complex and the T wave and has duration of 80 to 120 ms. It should be essentially level with the PR and TP segment. The normal ST segment has a slight upward concavity. Flat, downsloping, or depressed ST segment may indicate coronary ishcemia. Positive treadmill exercise stress test (>1.0 mm horizontal / downsloping or >1.5 upsloping ST segment depression measured 0.08 msec after the J point)."|Baseline|Exercise stress testing at baseline by treatment|||mm||Standard Deviation|Mean
1238050|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (Metabolism Equivalents)|Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.|Exit (12 weeks)|Exercise stress testing at exit (12 weeks) by treatment|||metabolism equivalents||Standard Deviation|Mean
1238051|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (Metabolism Equivalents)|Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.|Baseline|Exercise stress testing at baseline by treatment|||metabolism equivalents||Standard Deviation|Mean
1238052|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (METs)|Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain. A MET is defined as the resting metabolic rate, that is, the amount or oxygen consumet at rest, sitting quietly in a chair, approximately 3.5 ml O2 / kg / min (1.2 kcallmin for a 70-kg person). As such, work at METs requires twice the resting metabolism or 7.0 ml O2/kg/min, and so on.|Exit at 12 weeks|Exercise stress testing at exit (12 weeks) by treatment|||metabolism equivalents||Standard Deviation|Mean
1238053|NCT00600106|Primary|Inducible Myocardial Ischemia|Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-[average of rest and recovery periods]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio >20% from rest, and a lower value is considered indicative of greater ischemia.|12 weeks|Among the 35 women, 28 baseline and 26 exit MRS results were technically adequate for spectral analyses with rest, handgrip exercise, and recovery spectra. A total of 24 women (13 drug, 11 placebo) had both baseline and exit P31's.|||percent change in PCR/ATP ratio||Standard Deviation|Mean
1238089|NCT00599924|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. AUCinf was obtained by the Linear/Log trapezoidal method.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng*hr/mL||Standard Deviation|Mean
1238121|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12||Baseline to 12 weeks||||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
1238055|NCT00600106|Secondary|Quality of Life - Health Survey|"Quality of life assessed by cardiac symptoms and psychological questionnaires (SF 36 scale - Short Form Health Survey) The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.~Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|Baseline|SF-36 scale at baseline by treatment|||units on a scale||Standard Deviation|Mean
1238056|NCT00600106|Secondary|Quality of Life - Menopause Symptoms|Quality of life assessed by menopausal symptoms and psychological questionnaires|12 weeks|Menopause Symptoms at exit by treatment|||percent of participants|||Number
1238057|NCT00600106|Primary|Endothelial Dysfunction (FMD)|"Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of vasomotor function.~Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter [diameter after cuff deflation – baseline diameter / baseline diameter) x 100]."|12 weeks|Brachial artery reactivity testing at study exit by treatment|||percentage of pre-stimulus diameter||Standard Deviation|Mean
1238058|NCT00600106|Secondary|Quality of Life - Menopause Symptoms|Quality of life assessed by menopausal symptoms and psychological questionnaires|Baseline|Menopause Symptoms at baseline by treatment|||percent of participants|||Number
1238059|NCT00600106|Primary|Endothelial Dysfunction (FMD)|"Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of endothelial dysfunction.~Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter [diameter after cuff deflation – baseline diameter / baseline diameter) x 100]."|Baseline|Brachial artery reactivity testing at baseline by treatment|||percentage of pre-stimulus diameter||Standard Deviation|Mean
1238060|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (METs)|Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain. A MET is defined as the resting metabolic rate, that is, the amount or oxygen consumet at rest, sitting quietly in a chair, approximately 3.5 ml O2 / kg / min (1.2 kcallmin for a 70-kg person). As such, work at METs requires twice the resting metabolism or 7.0 ml O2/kg/min, and so on.|Baseline|Exercise stress testing at baseline by treatment|||metabolism equivalents||Standard Deviation|Mean
1238061|NCT00600106|Primary|Inducible Myocardial Ischemia|Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-[average of rest and recovery periods]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio >20% from rest, and a lower value is considered indicative of greater ischemia.|Baseline|Among the 35 women, 28 baseline and 26 exit MRS results were technically adequate for spectral analyses with rest, handgrip exercise, and recovery spectra. A total of 24 women (13 drug, 11 placebo) had both baseline and exit P31's.|||percent changed in PCR/ATP ratio||Standard Deviation|Mean
1238062|NCT00600080|Primary|Subjective Lens Comfort|"Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used."|2-week|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Least Squares Mean
1238063|NCT00600080|Secondary|Optimum Lens Fit|Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.|Baseline, 1-week, 2-week|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||participants|||Number
1238064|NCT00600080|Secondary|Subject-reported Overall Product Performance|"Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used."|2-week|Analyzed subjects were those who were enrolled and randomized to a study arm.|||units on a scale||Standard Error|Least Squares Mean
1238065|NCT00600080|Primary|Visual Acuity|Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.|2-week|Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study.|||logMAR scale||Standard Deviation|Mean
1238066|NCT00600067|Secondary|Percent Weight Loss From Baseline to Week 56||Baseline to 56 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
1238067|NCT00600067|Primary|HbA1c Change From Baseline Week 0 to Week 56||Baseline to 56 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
1238068|NCT00600028|Secondary|Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Visual Analog Scale of Cough and the St. George Respiratory Questionnaire.|"The secondary endpoint, suppression of cough was measured by the visual analog scale of cough (VAS) was significantly lower during treatment with thalidomide than placebo.~Secondary endpoints were Cough VAS - the visual analog scale of cough evaluates the severity of cough in patients with IPF.~Visual analog scale of cough ranges from 0 to 100 (0 is considered the best).~St. George Respiratory Questionnaire helps to evaluate cough-specific and respiratory quality of life in patients with IPF.~St. George Respiratory Questionnaire score ranges from 0 to 100 (0 is considered the best)."|6 months|All participants who received the interventions and completed all study visits were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1238069|NCT00600028|Primary|Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire.|"The primary endpoint, suppression of cough was measured by the Cough Quality of Life Questionnaire (CQLQ) to measure the effect of interventions on cough-specific quality of life.~CQLQ consist of 28 questions about cough and its effects using Likert-like 4-point scales, with lower scores indicating less effect of cough on health related quality of life.~CQLQ scale ranges from 28 to 112 ( The lower the value, the higher the quality of life, 28 is considered the best)."|6 months|All participants who received the interventions and completed all study visits were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1238070|NCT00600015|Secondary|Overall Survival (OS)||18 months||||Months||95% Confidence Interval|Median
1238071|NCT00600015|Secondary|6-month PFS||6 months|||||||
1238072|NCT00600015|Secondary|Duration of Response||18 months|||||||
1238073|NCT00600015|Secondary|Disease Control Rate (DCR)||18 months|||||||
1238074|NCT00600015|Primary|Progression Free Survival (PFS)||18 months||||Months||95% Confidence Interval|Median
1238075|NCT00600015|Primary|Overall Objective Response Rate (ORR)||18 months||||Percent||95% Confidence Interval|Number
1238076|NCT00599924|Secondary|Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI|IAUC: The initial area under the curve was estimated by integrating the area under the contrast agent concentration time course for the first 90 seconds after bolus arrival in the tumor.|Cycle 3 (Day 1) and Cycle 3 (Day 8)|No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.||||||
1238077|NCT00599924|Secondary|Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)|Volume endothelial Ktrans was estimated by fitting the tissue contrast agent time course to the Kety equation (Tofts model for analysis of DCE-MRI data).|Cycle 3 (Day 1), Cycle 3 (Day 8)|No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.||||||
1238078|NCT00599924|Secondary|Cmin of Free Platinum, Total Platinum, and 5-FU||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Cmin was not calculated for Free Platinum, Total Platinum, and 5-FU.||||||
1238079|NCT00599924|Secondary|CL/F of Free Platinum, Total Platinum, and 5-FU|CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|CL/F was not calculated for Free Platinum, Total Platinum, and 5-FU.||||||
1238080|NCT00599924|Secondary|T1/2 of Free Platinum, Total Platinum, and 5-FU|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free and total platinum were measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|T1/2 was not calculated for Free Platinum, Total Platinum, and 5-FU.||||||
1238081|NCT00599924|Secondary|Cmax of 5-FU||pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|Cmax of 5-FU was not calculated.||||||
1238082|NCT00599924|Secondary|Area Under the Curve (AUC) of 5-FU||pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|AUC for 5-FU was not calculated.||||||
1238083|NCT00599924|Secondary|Steady State Clearance (CLss) of 5-FU|CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||L/hr||Standard Deviation|Mean
1238084|NCT00599924|Secondary|Steady State Concentration (Css) of Fluorouracil (5-FU)|Steady state is reached when the amount of drug getting into the system per unit time is equal to the amount of drug cleared from the system.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
1238085|NCT00599924|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured. AUC48 = Area under the plasma concentration-time profile from time zero (pre-dose) to forty-eight hours. AUC48 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng*hr/mL||Standard Deviation|Mean
1238086|NCT00599924|Secondary|Tmax of Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
1238087|NCT00599924|Secondary|Cmax of Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
1238088|NCT00599924|Secondary|T1/2 for Free Platinum|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Standard Deviation|Mean
1238094|NCT00599924|Secondary|AUC24 for SU-012662 (Sunitinib's Metabolite)|AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng*hr/mL||Standard Deviation|Mean
1238095|NCT00599924|Secondary|Cmin of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
1238096|NCT00599924|Secondary|Tmax of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
1238097|NCT00599924|Secondary|Cmax of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
1238098|NCT00599924|Secondary|Terminal Phase Half-Life (t1/2) of Sunitinib|t1/2 = terminal phase half-life. t1/2 was obtained by natural log of 2 (ln2) divided by the rate constant for terminal phase (kel).|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|T1/2 for sunitinib was not calculated due to short observation time.||||||
1238099|NCT00599924|Secondary|Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib|AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng*hr/mL||Standard Deviation|Mean
1238100|NCT00599924|Secondary|Clearance (CL/F) of Sunitinib|Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||L/hr||Standard Deviation|Mean
1238101|NCT00599924|Secondary|Minimum Plasma Concentration (Cmin) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
1238102|NCT00599924|Secondary|Time to Cmax (Tmax) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
1238103|NCT00599924|Secondary|Maximum Plasma Concentration (Cmax) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed pharmacokinetic (PK) blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
1238104|NCT00599924|Secondary|Objective Response (OR)|From the start of treatment until disease progression/recurrence. OR=confirmed Complete Response (CR) or confirmed Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR = disappearance of all target lesions. CR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. PR = ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.|From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)|ITT|||participants|||Number
1238105|NCT00599924|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|up to 20 weeks|Intent to treat (ITT) = all subjects enrolled in the study that received at least one dose of study medication. Subjects who did not complete the follow-up period for dose limiting toxicity assessment because of death from progressive disease or other non-treatment related events were replaced.|||participants|||Number
1238106|NCT00599872|Secondary|Scores on a Scale (The Average Combined Allergy Symptom and Medication Score During the Ragweed Season for Each Subject)|The average combined allergy symptom and medication score during the ragweed season for each subject. This score is computed for each subject by adding their daily relief medication scores (excluding beta-agonist use) and their daily RSS for the entire ragweed season, and then taking the average of the combined scores across days.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
1238107|NCT00599872|Secondary|Scores on a Scale (Total Allergy Relief Medication Score During the Ragweed Season) for Each Subject|Total allergy relief medication score during the ragweed season for each subject. This score is computed for each subject by summing their individual medication scores (excluding beta-agonist use) for the entire ragweed season. High scores were indicative of poor symptom relief from the study medication. The associated relief medication scores assigned to medication are 0-if no medication taken; 3 for each one antihistamine tablet taken; 1 for each 2 antihistamine eye drop administrations, 1 for each 2 antihistamine nasal spray administrations and 1 for each puff of beta-agonist. The maximum medication score was dependent on the cumulative rescue medication use. The lower result the more favorable.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
1238108|NCT00599872|Secondary|Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);|The average daily RSS during the ragweed season for each of the 3 organ systems (ocular, nasal, ears) were separately analyzed to evaluate these individual components of the RSS. Three separate baseline average daily RSS values were computed for this analysis. The modified ITT population was used for this analysis. The range for scores: 0 to 3 for each of eight symptom or a total of 0 to 24 daily RSS. A lower score was more favorable.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
1238133|NCT00599313|Secondary|Objective Response Rate (ORR)|ORR = Complete Response (CR) + Partial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|12 months|Only patients with baseline measurable lesions.|||percentage of participants||95% Confidence Interval|Number
1238109|NCT00599872|Secondary|Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS (the sum of the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS)."|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
1238110|NCT00599872|Secondary|Scores on a Scale (Average Daily RSS During the Highest Pollen Count Week)|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.~The highest pollen count week was defined as the 7 contiguous days from the series with the largest average pollen count, and in which the weekly average was computed using at least 4 non-missing daily RSS values (either AM or PM could be present to be considered a valid daily RSS value)."|09/01/2008-09/07/2008|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||scores on a scale||Standard Deviation|Least Squares Mean
1238111|NCT00599872|Primary|Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season."|Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
1238112|NCT00599755|Post-Hoc|Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy At a Threshold of a 30% Decrease in SUVmean|Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 30% decrease in SUVmean of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Weeks 3 and 6 following chemotherapy|Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy|||Participants|||Number
1238113|NCT00599755|Secondary|Change in FGD-PET Uptake From Baseline to Week 6|"Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.~The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass."|Baseline and Week 6|Participants with PET scans at baseline and 6 weeks after starting chemotherapy.|||Fold change in SUVmean||90% Confidence Interval|Number
1238114|NCT00599755|Secondary|Change in FDG-PET Uptake From Week 3 to Week 6|Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Week 3 and Week 6|Participants with PET scans at 3 weeks and 6 weeks after starting chemotherapy|||Fold change in SUVmean||90% Confidence Interval|Number
1238115|NCT00599755|Secondary|Change in FDG-PET Uptake From Baseline to Week 3|Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Baseline and Week 3|Participants with PET scans at baseline and 3 weeks after starting chemotherapy|||Fold Change in SUVmean||90% Confidence Interval|Number
1238116|NCT00599755|Secondary|Repeatability of FDG SUVmean at Baseline|Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy|Participants who underwent two baseline PET scans|||SUVmean||Standard Deviation|Geometric Mean
1238117|NCT00599755|Primary|Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean|Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Weeks 3 and 6 following chemotherapy|Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy|||Participants|||Number
1238118|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Non-Infl Lesion||Standard Error|Least Squares Mean
1238119|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
1238120|NCT00599521|Secondary|Mean Percent Change in Total Lesion Count From Baseline to Week 12|Percent change in lesion count from baseline to week 12|From Baseline to 12 weeks||||% Change in Lesion Count||Standard Deviation|Mean
1238122|NCT00599521|Primary|Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12|"Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe."|From Baseline to Week 12||||Percentage of Participants|||Number
1238123|NCT00599339|Secondary|Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)|The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.|33 months|For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.|||Adverse Events|||Number
1238124|NCT00599339|Secondary|Hoehn & Yahr Stage at Visit 7 (Month 33)|"The Hoehn and Yahr staging of Parkinson’s disease in the “on” stage, if applicable, had to be completed by the physician.~Possible staging:~0 No signs of disease~1 Unilateral disease~2 Bilateral disease without impairment of balance~3 Mild to moderate bilateral disease, some postural instability, physically dependent~4 Severe disability, still able to walk or stand unassisted~5 Wheelchair bound or bedridden unless aided"|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||participants|||Number
1238125|NCT00599339|Secondary|Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)|"The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.~The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7."|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
1238126|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson’s disease rating scale (UPDRS) Part IV question 39 asks “What proportion of the waking day is the patient off, on average? Answers range from 0 (None) to 4 (76-100 % of the day)."|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
1238127|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)|The Unified Parkinson’s disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question “How disabling are the dyskinesias ? “ Answers range from 0 (Not disabling) to 4 (Completely disabling).|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
1238128|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson’s disease rating scale (UPDRS) question 32 of part IV asks. What Proportion of the waking day are dyskinesias present? Answers range from 0 (None) to 4 (76-100 % of the day)."|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
1238129|NCT00599339|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)|The Unified Parkinson’s disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
1238130|NCT00599326|Secondary|Number of Participants Showing Decrease in Ferritin and Urinary Porphyrin Level|Patients with PCT usually have normal or elevated serum iron and ferritin levels as well as increased iron absorption. Phlebotomy is conducted to analyzes the ferritin levels. Urine collection is performed and samples of the urine are analyzed for porphyrin levels.|6 months||||participants|||Number
1238131|NCT00599326|Primary|Number of Participants Showing Reduction or Elimination of Skin Blistering|The present trial was undertaken to determine if oral deferasirox could be useful in the treatment of PCT. Monthly clinic visits with a physical examination was conducted to assess the skin for blisters.|Within 6 months of treatment.||||participants|||Number
1238132|NCT00599313|Secondary|Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.|Pain score decreased >=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week’s average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week’s period.|Baseline and up to 12 months|Patients with pain measurement at baseline.|||percentage of participants||95% Confidence Interval|Number
1238136|NCT00599313|Secondary|Overal Survival (OS) Rate at 1-year.|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|12 months|ITT population|||Probability of Survival at 1-year||95% Confidence Interval|Number
1238137|NCT00599313|Primary|Median Progression-free Survival (PFS) Time at 1-year.|"PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|12 months|ITT population|||weeks||Full Range|Median
1238138|NCT00599248|Secondary|Number of Patients With Improvements in Pain and Function of the Knee Joint|Assessment of the number of patients with improvement in pain and function of the knee joint|28 Days||||participants|||Number
1238139|NCT00599248|Secondary|Number of Patients With Tissue Overgrowth or Transformation in the Knee Joint|Visual and histological analysis of knee joint tissues to determine the number of patients with tissue overgrowth or transformation|29||||participants|||Number
1238140|NCT00599248|Secondary|Number of Participants With Observable Evidence of Cartilage Regeneration|The evaluation of regeneration of hyaline cartilage as determined by histological analysis of resected knee tissue and observation for engraftment and cartilage production.|Days 0, 3, 7, 11, 28 (prior to surgery), and day 29 (one day post-surgery) following dosing. Follow-up patient monitoring will be performed at 3, 6, 9, and 12 months following dosing|Intention-to-treat|||participants|||Number
1238141|NCT00599248|Secondary|Number of Patients With Distribution of hChonJb#7 Cells Detected Outside of the Injection Site|Number of Patients with Distribution of hChonJb#7 Cells Detected Outside of the Injection Site as determined by PCR analysis for vector DNA.|12 Months||||participants|||Number
1238142|NCT00599248|Secondary|Number of Patients Showing Engraftment at the Defect|Dose Response of the TG-C in Engrafting at the Defect as Compared to Placebo Control|28 Days||||participants|||Number
1238143|NCT00599248|Primary|Summary of Adverse Events|The incidence of observations at the site of administration and the incidence adverse events assessed through 28 days after treatment.|Through 28 days post-dosing|Intention-to-treat|||Adverse events|||Number
1238144|NCT00599196|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 380 subjects who are included in the Safety Set (SS), 5 subjects discontinued prior to entering the maintenance phase (n=375), however 2 of these subjects returned for the End of Treatment visit (n=377). Last observation carried forward (LOCF) was utilized for subjects who entered the maintenance phase.|||Score on a scale||Standard Deviation|Mean
1238145|NCT00599196|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|six years|Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.|||Subjects|||Number
1238146|NCT00599196|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|six years|Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.|||Subjects|||Number
1238147|NCT00599131|Secondary|The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia|To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.|3 years.|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.||||||
1238148|NCT00599131|Secondary|Overall Survival Time|To determine the overall survival rates compared to the overall survival rates of historical controls.|3 years|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.||||||
1238149|NCT00599131|Secondary|The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.|To evaluate the quality of life (QOL).|24 months|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.||||||
1238150|NCT00599131|Secondary|The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF.|To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies.|Day 23|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.||||||
1238151|NCT00599131|Primary|Percentage of Patients Achieving Histologic Complete Response|The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.|3 years|The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.||||||
1238152|NCT00599053|Primary|Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Number of serious of adverse event experienced by subjects treated with azithromycin|from day 1 of study drug through 100 days or discharge from hospital, which ever comes first||||number of events||Full Range|Mean
1238153|NCT00599053|Primary|Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.|100 days or discharge from hospital|Unable to determine Pharmacokinetics (PK) data due to low enrollment||||||
1238154|NCT00599053|Secondary|Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups|Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.|from baseline to 100 days or discharge from Hospital, which ever comes first||||days||Full Range|Mean
1238155|NCT00599053|Primary|Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy|100 days or discharge from hospital|Unable to determine efficacy due to low enrollment||||||
1238156|NCT00599027|Primary|The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.|To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30.|Baseline and 28 days of treatment||||units on a scale||Standard Deviation|Mean
1238157|NCT00599014|Secondary|Hospitalization||30 days||||participants|||Number
1238158|NCT00599014|Primary|Death, Heart Transplant, Left Ventricular Assist Device Implantation||5 years||||participants|||Number
1238159|NCT00598871|Secondary|Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)|Number of diabetic patients who had undergone epithelial debridement during vitrectomy resulted in complete corneal wound closure of the affected eye at the end of treatment (Day 14)|14 days|Analysis per protocol, ITT (Intent to treat), using LOCF (Last Observation Carried Over)|||participants|||Number
1238160|NCT00598871|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) After Treatment With Thymosin Beta 4 in the Target Eye of Diabetic Patients During Vitrectomy|Number of participants with Number of Treatment Emergent Adverse Events (TEAEs) in the Target Eye in diabetic patients who had undergone epithelial debridement during vitrectomy and treated with thymosin beta 4|14 days|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)|||Participants|||Number
1238161|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Non-Infl Lesion count||Standard Error|Least Squares Mean
1238162|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
1238163|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
1238164|NCT00598832|Secondary|Mean Percent Change in Total Lesion Count From Baseline to Week 12|Percent change in lesion count from baseline to week 12|From Baseline to Week 12||||% Change in Lesion Count||Standard Deviation|Mean
1238165|NCT00598832|Primary|Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12|"Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe."|From Baseline to Week 12||||Percentage of Participants|||Number
1238166|NCT00598819|Primary|Overheating of Skin Underneath Sensor|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|placement of sensor to immediately post-removal||||Participants|||Number
1238167|NCT00598819|Secondary|Sensor Attachment Under Stress|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|addition of stress on sensor to removal.||||Participants|||Number
1238168|NCT00598819|Secondary|Sensor Fits Well on Subjects Forehead|"How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test was performed by hanging weight of 2 LBS on the sensor for 10 min, recording if the sensor kept attached to the skin or not. All tests and measures were assessed by the investigator. All the characteristics of the sensor (curvature, comfort and adherence) were recorded on each subjects as yes or no."|placement of sensor to end of study observation||||Participants|||Number
1238169|NCT00598819|Primary|Overheating of Skin Underneath Sensor.|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|placement of sensor to 10 minutes post-removal.||||Participants|||Number
1238283|NCT00597012|Secondary|SF-36 Physical Functional Status Scale - Difference From Baseline|Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity.|6 months||||Score||95% Confidence Interval|Mean
1238170|NCT00598819|Primary|Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.|Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measurement and reactions assessment performed by the investigator.|attachment of sensor to 24 hours post-removal|The number of participants was determined by protocol specifications.|||Participants|||Number
1238171|NCT00598806|Secondary|Overall Survival|The number of months from randomization to death from any cause.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1238172|NCT00598806|Secondary|Disease-Free Survival|The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1238173|NCT00598806|Secondary|Disease-Free Interval|The number of months from randomization to histologically confirmed progression of the patient’s bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1238174|NCT00598806|Secondary|Number of Recurrences Per Patient|The number of histologically confirmed recurrences during the course of the study.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||recurrences||Standard Deviation|Mean
1238175|NCT00598806|Secondary|Time to Progression|The number of months from randomization to progression to either a higher stage or grade of the patient’s bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1238176|NCT00598806|Secondary|Progression Rate at 2 Years|The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||Participants|||Count of Participants
1238177|NCT00598806|Secondary|Time to Recurrence|The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1238178|NCT00598806|Primary|Recurrence Rate at 2 Years|The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||Participants|||Count of Participants
1238179|NCT00598702|Primary|Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event|"A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;~results in death~is life-threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose to 30 days after last dose|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.|||Subjects|||Number
1238180|NCT00598702|Secondary|Physician's Global Assessment of Study Treatment|Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).|End of study or Early Termination|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.|||participants|||Number
1238181|NCT00598702|Primary|Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)|A TEAE is defined as an adverse event that starts on or after the start of study medication.|First dose to end of treatment period|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.|||Subjects|||Number
1238182|NCT00598702|Secondary|Subject's (Parent/Guardian) Global Evaluation of Study Treatment|Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).|Day 0 to Day 5, Day 7 or Early Termination from study|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.|||participants|||Number
1238183|NCT00598689|Secondary|Tolerability and Alleviation of Post-operative Pain in LASIK Surgery|A comparison of subjective comfort level defined as tolerability and alleviation of post-operative pain experienced as a result of post-operative application of GenTeal drops. Subjective pain level was measured on a 10 point likert scale where 0 = no pain and 10 = worst pain possible. A lower score at Week 1 as compared to Day 1 was considered improved. A same score or higher at week 1 as compared to day 1 was considered no improvement.|Week 1 post surgery|Subjects randomized to either group and completed LASIK surgery.|||percentage of subjects|||Number
1238287|NCT00596960|Primary|Percent Days Abstinent From Alcohol at 6 Months|Alcohol use was measured for 30 days at baseline, 3-months and 6-months using the time-line follow back method. Percent days abstinent was measured by determining: days abstinent/30days X 100=%days abstinent.|6-months||||percentage of days abstinent||Standard Deviation|Mean
1238184|NCT00598689|Secondary|Post Operative Pain Level|Assess whether preoperative GenTeal Gel alleviates post operative pain in LASIK surgery patients compared to control (no preoperative lubricant) as measured by patient completion of the Universal Pain Assessment Tool (moderate), a ten point scale with 0 being no pain and 10 being the worst pain possible. Data on the level of pain only in the right eye will be collected.|Day 1, End of Week 1|Subjects that completed LASIK surgery.|||units on a scale||Standard Deviation|Mean
1238185|NCT00598689|Primary|Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery|Assess whether preoperative GenTeal Gel enhances epithelial healing after LASIK surgery within the first post-operative week, compared to control (no preoperative lubricant). Healing of the area of the cornea covering the radius of the sectioned into clock hours 0 - 12 where 0 hours equals no healing and 12 hours equals complete healing.|Day 1, End of Week 1|Subjects that completed LASIK surgery.|||Clock Hours||Standard Deviation|Mean
1238186|NCT00598650|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms|"NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes."|Baseline, Week 52, and Week 52 LOCF|Efficacy Analysis Set|||Score on a Scale||Standard Deviation|Mean
1238187|NCT00598650|Primary|Change From Baseline in Mini-mental State Examination (MMSE) Total|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.|Baseline, Week 52, and Week 52 LOCF|Efficacy Analysis Set: subjects who received at least one dose of E2020 and also provided safety assessment data after baseline, with at least one available efficacy evaluation. Two subjects whose diagnosis was suspected not to meet clinical criteria of probable DLB and 2 subjects with lack of efficacy data were excluded from the efficacy analysis.|||Score on a Scale||Standard Deviation|Mean
1238188|NCT00598585|Primary|Change in Fatigue Impact Scale at 6 Weeks|change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated|6 weeks||||units on a scale||Standard Deviation|Mean
1238189|NCT00598559|Secondary|Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.|Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7.|Study period lookback at Day 7|Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.|||Units on a scale||Standard Deviation|Mean
1238190|NCT00598559|Primary|Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)|"Serious TEAE is any untoward medical occurrences at any dose of study medication that:~results in death~is life threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose (T0) to within 30 days of the last dose of study medication.|Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.|||Participants|||Number
1238191|NCT00598559|Primary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).|"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).~A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)."|T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up|Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.|||Participants|||Number
1238192|NCT00598559|Secondary|Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments|Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge)|End of Day 5 (prior to discharge)|Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.|||Units on a scale||Standard Deviation|Mean
1238193|NCT00598507|Secondary|Occurrence of Attributable Serious Adverse Events (SAEs)|Number of participants with Grade 3 or higher adverse events, attributable to treatment with sagopilone.|Up to 5 years|All participants|||participants|||Number
1238194|NCT00598507|Secondary|Median Overall Survival (OS)|Median OS: the time (expressed in months or years) when half the patients are expected to be alive.|Up to 5 years|All participants|||weeks||95% Confidence Interval|Median
1238195|NCT00598507|Secondary|Median Progression Free Survival (PFS)|PFS: the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD)according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 5 years|All participants|||weeks||95% Confidence Interval|Median
1238196|NCT00598507|Primary|Response Rate (RR)|Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 5 years|All participants|||participants|||Number
1238197|NCT00598442|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods|A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.|Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
1238198|NCT00598442|Secondary|Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
1238199|NCT00598442|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.|Baseline and Weeks 25-36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||g/dL||Standard Deviation|Mean
1238200|NCT00598273|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods.|A hemoglobin response is defined as hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.|Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
1238201|NCT00598273|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
1238202|NCT00598273|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.|Baseline and Weeks 25-36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||g/dL||Standard Deviation|Mean
1238203|NCT00598078|Primary|Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor|The modified FTM sum of all essential rating tremor scales including voice tremor includes: the tremor rating taken for the left & right hands individually at rest, with posture (arms outstretched), with action (finger to nose). It also includes an evaluation of voice with scores for AAA & EEE sounds, an action evaluation of left & right hands pouring, bringing liquids to mouth, drawing large & small spirals. Scores for indiviuals items range from 0 (no tremor) to 4 (severe tremor). The sum ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors).|Hour 1||||Points||90% Confidence Interval|Least Squares Mean
1238204|NCT00597909|Secondary|Pharmacokinetic Characteristics of Ammonul® and Its Metabolites||Every 24 hours during treatment period of 96 hours|||||||
1238205|NCT00597909|Secondary|Effects of Ammonul® on Blood Ammonia Levels, Amino Acids and Carnitine||96 hours of treatment and follow-up|||||||
1238206|NCT00597909|Secondary|Efficacy, as Assessed by Severity of Hepatic Encephalopathy Using the Glasgow Coma Scale||96 hours of treatment and follow-up|||||||
1238207|NCT00597909|Secondary|Efficacy, as Assessed by Percentage of Subjects With a 1 or 2 Grade Improvement, Using the West Haven Criteria||participants will be followed for the duration of hospital stay, an expected average of 96 hours|||||||
1238208|NCT00597909|Secondary|Efficacy, as Assessed by Time Spent in an Improved State by 1 or 2 Grades Using the West Haven Criteria||96 hours of treatment and follow-up|||||||
1238209|NCT00597909|Secondary|Efficacy, as Assessed by Proportion of Assessments With 1-grade Improvement, Using West Haven Criteria||96 hours of treatment and follow-up|||||||
1238210|NCT00597909|Secondary|Efficacy, as Assessed by Proportion of Assessments With a 2-grade Improvement, Using West Haven Criteria||96 hours of treatment and follow-up|||||||
1238211|NCT00597909|Secondary|Safety, as Assessed by Reported Adverse Events, Clinical Laboratory Measurements, Changes in Vital Signs, and Changes in 12-lead ECG Results||96 hours of treatment and follow-up|||||||
1238212|NCT00597909|Primary|Efficacy, as Assessed by Time to Grade 2 or Less in the West Haven Criteria Sustaining for 4 Hours or Longer||Time to Grade 2 or less sustaining for 4 hours or longer|One participant enrolled but did not receive drug or was randomized.||||||
1238213|NCT00597896|Primary|Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency|The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||words||Standard Deviation|Mean
1238214|NCT00597896|Primary|Change From Baseline to Week 8 in Hopkins Verbal Learning Test|The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||words||Standard Deviation|Mean
1238215|NCT00597896|Primary|Change From Baseline to Week 8 in d2 Test of Attention|"The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the d's with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed."|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||units on a scale||Standard Deviation|Mean
1238216|NCT00597896|Primary|Change From Baseline to Week 8 in Trail Making Test Part B|The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe “executive” functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||seconds||Standard Deviation|Mean
1238217|NCT00597896|Primary|Change From Baseline to Week 8 in Trail Making Test Part A|The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe “executive” functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||seconds||Standard Deviation|Mean
1238218|NCT00597896|Primary|Change From Baseline to Week 8 in Stroop Color-Word Test|The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with ‘Xs’ printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||words||Standard Deviation|Mean
1238219|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test|Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||units on a scale||Standard Deviation|Mean
1238220|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)|The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||number of correct numbers recalled||Standard Deviation|Mean
1238221|NCT00597896|Secondary|Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint|The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 (“Insight”) which is rated on a 5-point Likert scale. These items yield two subscale scores—one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||units on a scale||Standard Deviation|Mean
1238222|NCT00597896|Secondary|Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||units on a scale||Standard Deviation|Mean
1238223|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)|The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||number of correct numbers recalled||Standard Deviation|Mean
1238224|NCT00597766|Secondary|Pain Free Abduction Range of Motion (ROM)|Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.|Baseline, weeks 4, 8, 12 (4 times)|Available-case analysis with missing data handled by maximum likelihood methods.|||units on a scale||95% Confidence Interval|Least Squares Mean
1238225|NCT00597766|Secondary|Pain Free External Rotation Range of Motion (ROM)|Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.|Baseline, weeks 4, 8, 12 (4 times)|Available-case analysis with missing data handled by maximum likelihood methods.|||units on a scale||95% Confidence Interval|Least Squares Mean
1238284|NCT00597012|Secondary|KOOS Pain - Difference From Baseline|Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the difference between the study groups with respect to the change in the score on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) from baseline to 6 months after randomization.|Baseline to 6 months||||Score||95% Confidence Interval|Mean
1238226|NCT00597766|Secondary|Fugl-Meyer Motor Assessment, Upper Limb Domain|"Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale:~0 = cannot perform~= performs partially~= performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions."|Baseline, weeks 4, 8, 12 (4 times)|Available-case analysis with missing data handled by maximum likelihood methods.|||units on a scale||95% Confidence Interval|Least Squares Mean
1238227|NCT00597766|Primary|BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire|Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.|Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)|We used available-cases. Missing values handled with maximum likelihood methods.|||units on a scale||95% Confidence Interval|Least Squares Mean
1238228|NCT00597753|Secondary|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)||Weeks 29 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
1238229|NCT00597753|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
1238230|NCT00597753|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.|Baseline and Weeks 29-36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||g/dL||Standard Deviation|Mean
1238231|NCT00597727|Secondary|Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing|Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.|36-60 months|Although the 12 month OFC was discontinued beginning in 7/2010, all subjects reaching the end of study (36-60 months of treatment) underwent an OFC resulting in more patients performing the end of study OFC than the 12 month OFC.|||percentage of participants|||Number
1238232|NCT00597727|Primary|Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing|Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.|12 months|Interim analysis in 7/2010 showed statistically significant difference in peanut tolerated during oral food challenge (OFC) by active treatment vs placebo (1710mg vs 85mg). Further OFCs for those on placebo was considered more risk than benefit thus were discontinued resulting in subsequent patients being unblinded after 12 months without an OFC|||percentage of participants|||Number
1238233|NCT00597714|Secondary|Graft Failure|Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3–5 weeks after transplant to assess donor-cell engraftment. Primary Graft Failure was defined as a neutrophil count below 500/μL or the absence of donor-derived hematopoiesis (<5%donor cells) before relapse, death, or re-transplantation. Secondary Graft Failure was defined as the achievement of primary engraftment and a subsequent decrease in neutrophils to 3 consecutive counts of less than 100/μL or the absence of donor-derived hematopoiesis (<5% donor cells) before relapse, death, or re-transplantation.|180 days|All subjects who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and donor type.|||number of participants|||Number
1238234|NCT00597714|Other Pre-specified|Graft Versus Host Disease|Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3–5 weeks after transplant to assess donor-cell engraftment. Acute or chronic GVHD was diagnosed and graded according to standard criteria. Toxicity was formally graded using the National Cancer Institute Common Toxicity Criteria version 3.0.|180 days|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and Graft Failure and donor type.|||percentage of participants||95% Confidence Interval|Number
1238288|NCT00596960|Primary|The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up.|A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. The number of drinks per week was measured for 30 a day time frame at baseline, 3 months and 6-months.|6-months||||Standard Alcohol drinks||Standard Deviation|Mean
1238235|NCT00597714|Secondary|Overall Survival|Estimate overall survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. OS was defined as the period of time between the day of transplantation and death. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants surviving 2 years by donor type is reported.|2 years|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).|||percentage of participants||95% Confidence Interval|Number
1238236|NCT00597714|Secondary|Progression Free Survival|Progression-free survival (PFS) rates after stem cell transplant were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. PFS was defined as the period of time between the day of transplantation and either the day underlying disease progression was documented or death occurred by any cause. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants progression free at 2 years is reported by donor type. Progression = > 25% increase of serum M-protein and/or urine M-protein. Also, an absolute increase in bone marrow plasma cells > 10%, new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.|2 years|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).|||percentage of participants||95% Confidence Interval|Number
1238237|NCT00597714|Secondary|Immune Recovery|Evaluate immune recovery following this reduced intensity allogeneic immunotherapy. Quantification of CD3+, CD4+, and CD8+ T cells was performed by flow cytometry on fresh peripheral blood at approximately 1 month before transplantation and then 1.5, 3, 6, and 12 months after transplantation. The immune recovery rates of the CD3+, CD4+, and CD8+ T cells in the MRD, MUD, and HAPLO groups were compared by performing an analysis of variance at each time point after transplantation. The median T cell counts at 12 months for each type of cell are reported by donor type.|1 year|All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).|||T cells/μL||Standard Deviation|Mean
1238238|NCT00597714|Primary|Disease Free Survival|Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease relapse or death due to the disease. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants who were disease free at 2 years is reported by donor type.|2 years|All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. DFS was analyzed by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).|||percentage of participants||95% Confidence Interval|Number
1238239|NCT00597701|Primary|Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups|In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.|From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed.||||mg of benzodiazepine per 8 hours||Standard Deviation|Mean
1238240|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood.|Peanut specific IgG4 is thought to have a protective effect for a subject when exposed to peanut possibly by interfering with IgE. Peanut-specific IgG4 is measured from serum in the blood by an immunoCAP machine and reported in mg/dL. A higher level of peanut-specific IgG4 could suggest a decrease in the probability of reaction for a subject who is exposed to peanut.|Baseline to end of open label phase treatment (36-60 months)||||mg/dL||Full Range|Median
1238241|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood|Peanut specific IgE on the surface of mast cells and basophils releases histamine when exposed to peanut causing symptoms of allergy. Free-floating peanut-specific IgE is measured from serum in the blood by an immunoCAP machine and reported in kU/L. A lower level of peanut-specific IgE could suggest a decrease in the probability of reaction for a subject who is exposed to peanut.|Baseline to end of open label phase treatment (36-60 months)||||kU/L||Full Range|Median
1238242|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing|Skin prick testing is performed by scratching the skin with a small amount of peanut and observing for redness and a raised bump called a wheal. The diameter of the wheal is measured with a ruler in mm and recorded as a measure of peanut-specific IgE and mast cell reactivity in an allergic subject. A decrease in wheal size after treatment would represent suppression of the allergic response.|Baseline to end of open label phase treatment (36-60 months)||||mm||Full Range|Median
1238289|NCT00596947|Secondary|The Number of Participants With Weight Gain|Height, weight will be used to calculate change in BMI for all participants.|12 months|unable to interpret results due to low number of patients enrolled.||||||
1238243|NCT00597675|Secondary|The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment.|After 12 months of blinded Peanut OIT treatment, the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 4710 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.|12 months||||mg of peanut protein||Full Range|Median
1238244|NCT00597675|Primary|The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT.|After completing the peanut OIT protocol (defined as treatment with peanut OIT for at least 36-months AND a peanut-specific IgE >2 and <15 AND skin prick test is <5 mm OR a maximum of 60 months of treatment), the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 5000 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.|36-60 months||||mg of peanut protein||Full Range|Median
1238245|NCT00597584|Secondary|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)||Weeks 29 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
1238246|NCT00597584|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
1238247|NCT00597584|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.|Baseline to Weeks 29-36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||g/dL||Standard Deviation|Mean
1238248|NCT00597558|Secondary|Serum CAP-FEIA to Egg|Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline|24-60 months||||ku/L||Full Range|Mean
1238249|NCT00597558|Secondary|Egg Protein Skin Prick Test After Egg OIT|Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.|24-60 months||||mm||Full Range|Mean
1238250|NCT00597558|Primary|Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg|Subjects will have a double-blind, placebo-controlled food challenge (DBPCFC) to egg after at least 24 months of egg OIT when the IgE to egg is < 7 kU/L or 90% of entry level IgE or SPT <= 5mm with a maximum treatment period of 60 months.|24-60 months||||subjects with no symptoms on DBPCFC|||Number
1238251|NCT00597545|Primary|Number of Participants With Improved Neuropsychometric Changes|Battery of neuropsychometric tests to evaluate a variety of cognitive functions.|Post-operatively at 1 day||||participants|||Number
1238252|NCT00597519|Primary|Overall Response|To obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall response.|1 year||||participants|||Number
1238253|NCT00597506|Primary|Progression Free Survival (PFS)|8 week PFS|interval between start of treatment and 8-week|50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.|||proportion of participants||90% Confidence Interval|Number
1238254|NCT00597506|Primary|Overall Response|Overall response is composed of complete responses and partial responses. Complete response (CR): disappearance of all target lesions; Partial response: at least a 30 percent decrease in the sum of the longest diameter of the target lesions taking as reference the baseline sum longest diameter. Response is assessed at each subject's restaging, approximately ever 2 months.|Measured 1 month after the last treated subject came off treatment|50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.|||percentage of participants|||Number
1238255|NCT00597493|Secondary|Pharmacokinetics: AUC-24|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. AUC-24 refers to area under the plasma concentration-time curve from 0 to 24 hours. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAEDs) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.|||ug*H/L||Geometric Coefficient of Variation|Geometric Mean
1238256|NCT00597493|Secondary|Pharmacokinetics: T-max|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. T-max refers to time to maximum concentration. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAED) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.|||hours||Full Range|Median
1238309|NCT00596934|Secondary|Fasting Glucose Value at 12 Months|Fasting glucose value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||mg/dL||Standard Deviation|Mean
1238310|NCT00596934|Secondary|Liver Function Test: Aspartate Aminotransferase (AST) Values at 12 Months|AST value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||IU/L||Standard Deviation|Mean
1238257|NCT00597493|Secondary|Pharmacokinetics: C-max|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. C-max refers to maximum plasma concentration. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAED) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.|||ug/L||Geometric Coefficient of Variation|Geometric Mean
1238258|NCT00597493|Secondary|Safety and Toxicity of Combination|Number of participants experiencing a toxicity of at least grade 3 that was deemed possibly, probably, or definitely related to the treatment.|16 months||||participants|||Number
1238259|NCT00597493|Primary|6 Month Progression Free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months||||percentage of patients||95% Confidence Interval|Number
1238260|NCT00597428|Secondary|Treatment Effectiveness|Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective|Weeks 1-12|Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12).|||units on a scale||Standard Deviation|Mean
1238261|NCT00597428|Secondary|Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity|Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular|Weeks 1-12||||units on a scale||Standard Deviation|Mean
1238262|NCT00597428|Secondary|Responder Rate|Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.|Up to 12 weeks||||participants|||Number
1238263|NCT00597428|Secondary|First Post-dose SBM|The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.|24 and 48 hours post-dose||||participants|||Number
1238264|NCT00597428|Secondary|Change From Baseline in Mean Weekly SBM Frequency|For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.|Baseline, Week 12, and Weeks 1-12||||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
1238265|NCT00597428|Primary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8||Baseline and Week 8||||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
1238266|NCT00597402|Secondary|Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity|Number of times a grade ≥ 4 hematologic or grade ≥ 3 non-hematologic toxicity was experienced|55 months||||participants|||Number
1238267|NCT00597402|Secondary|Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage|Number of times a CNS hemorrhage or systemic hemorrhage was experienced|55 months||||participants|||Number
1238268|NCT00597402|Secondary|12-month Progression-free Survival (PFS)|Percentage of participants surviving twelve months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|12 months||||percentage of participants||95% Confidence Interval|Number
1238269|NCT00597402|Primary|16-month Overall Survival (OS)|Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause.|16 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1238270|NCT00597376|Secondary|Six Month Levels of Inflammation and Oxidative Stress Markers(as a Percent of Baseline Levels) After Daily Treatment With Cerefolin NAC and a Multivitamin or a Multivitamin Only|Outcome measures were 6-month levels of highly sensitive c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), malondialdehyde, and potential anti-oxidant (PAO)in blood samples as a percent of baseline value.|6 months|All participants in Intent-to-Treat were included with last observation carried forward.|||percent of baseline level||95% Confidence Interval|Mean
1238271|NCT00597376|Secondary|Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only|Mean study product compliance was measured as the actual number of study product tablets taken as a percent of the maximum study product tablets that could have been taken during the intervention period.|6 months|All participants in Intent-to-Treat cohort were included.|||percent of study drug taken||Standard Error|Mean
1238285|NCT00597012|Primary|WOMAC Functional Status - Difference From Baseline|Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 6 months after randomization.|Baseline and 6 months||||Score||95% Confidence Interval|Mean
1238286|NCT00596960|Secondary|Heavy Drinking Days (Greater or Equal to 4 Drinks)|This was measured as heavy drinking days per 30 day time frame. A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. A heavy drinking day was considered to be 4 or greater drinks during a day.|6-months||||heavy drinking days||Standard Deviation|Mean
1238272|NCT00597376|Primary|Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only|Primary outcome markers were plasma homocysteine (tHcy), glutathione, and the ratio of amyloid proteins, Aβ42 and Aβ40. Plasma tHcy and glutathione were assayed using a high performance liquid chromatography (HPLC) with fluorescence detection method. Enzyme-linked immunosorbent assays (ELISA) were used for Aβ42 (Wako Chemicals USA, Inc., Richmond, VA) and Aβ40 (Invitrogen Corporation, Canarillo, CA) detection. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess the primary biomarker level at 6 months versus baseline. Six month levels in biomarker outcomes were compared using t-tests of the logarithmically transformed values and the antilogarithm was applied to the SDs obtain 95% confidence intervals (95% CIs). A significant difference between treatments was needed for at least one of the primary outcome variables (tHcy, glutathione, or the Aβ42 to Aβ40 ratio) to declare the study positive.|6 months|The Intent-to-Treat (ITT) cohort included randomized subjects taking at least one study treatment dose. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess 6 month levels in the primary biomarkers. 2-sided, t-test p-value for group differences was only significant (<0.05) for 6-month homocysteine level.|||percent of baseline level||95% Confidence Interval|Mean
1238273|NCT00597272|Primary|Toxicity|Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|2 years||||participants|||Number
1238274|NCT00597207|Primary|Hospital Discharge|Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.|From time of first contact until hospital discharge, up to 90 days.||||participants|||Number
1238275|NCT00597116|Secondary|Overall Survival (OS)||Assessed from baseline to 12 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.|||Months||95% Confidence Interval|Median
1238276|NCT00597116|Secondary|Progression-free Survival (PFS)|Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.|Assessed from baseline to 12 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.|||Months||95% Confidence Interval|Median
1238277|NCT00597116|Secondary|Number of Participants With Objective Response.|Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.|Assessed at 2 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.|||Participants|||Number
1238278|NCT00597116|Primary|Number of Participants With Disease Control.|Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.|Assessed at 2 months.|Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment.|||Participants|||Number
1238279|NCT00597038|Secondary|Number of Participants With 12 Month Overall Survival (OS)|Phase II - To determine Overall Survival of patients treated with the combination of dasatinib and DTIC at 12 months.|12 Months|All participants|||participants|||Number
1238280|NCT00597038|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|Phase II - PFS Rate in patients receiving dasatinib 70 mg orally (PO) twice a day (BID). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved. Stable disease was defined as maintenance of the sum of lesions diameters between a 30% reduction and a 20% increase of overall tumour size over 12 weeks or longer.|6 Months|Patients receiving dasatinib at 70 mg PO BID|||participants|||Number
1238281|NCT00597038|Primary|Phase II - Number of Participants With Overall Response (OR)|Phase II - To determine the overall response rate (ORR) of the combination of dasatinib and DTIC by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved.|1 Year 6 Months|Patients receiving dasatinib at 70 mg PO BID|||participants|||Number
1238282|NCT00597038|Primary|Recommended Phase II Dose|To determine the maximum tolerated dose of dasatinib twice a day when given with dacarbazine. Adverse events were graded using Common Terminology Criteria for Adverse Events version 3.0. Dose-limiting toxicities are defined as any grade 4 haematological toxicity (except asymptomatic grade 4 neutropenia for =/< 7 days); prolonged grade 3 or 4 thrombocytopenia (47 days) or thrombocytopenia associated with bleeding, requiring platelet transfusion; any grade 3 or 4 nonhaematological toxicity despite optimal supportive care; any toxicity considered unacceptable by the study principal investigator.|1 Year 3 Months|All participants in Arm A|||mg|||Number
1238290|NCT00596947|Secondary|The Number of Participants With Post Transplant Diabetes Mellitus|"Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months.~Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants."|pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months|unable to interpret results due to low number of patients enrolled.||||||
1238291|NCT00596947|Secondary|The Number of Participants With Bone Disease|Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months.|baseline (within 1 month post-transplant), 3, 6, 12 and 24 months|unable to interpret results due to low number of patients enrolled.||||||
1238292|NCT00596947|Secondary|The Number of Participants With Hyperlipidemia|Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
1238293|NCT00596947|Secondary|The Number of Participants With Hypertension|The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study.|12 months|unable to interpret results due to low number of patients enrolled.||||||
1238294|NCT00596947|Secondary|The Number of Participants With Malignancy|Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
1238295|NCT00596947|Secondary|The Number of Participants With Infections|Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
1238296|NCT00596947|Secondary|The Number of Participants With Leukopenia|All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL).|12 months|unable to interpret results due to low number of patients enrolled.||||||
1238297|NCT00596947|Secondary|The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.|The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician.|12 months|unable to interpret results due to low number of patients enrolled.||||||
1238298|NCT00596947|Primary|Participant Survival|The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.|6 and 12 months|data not interpretable due to low patient enrollment||||||
1238299|NCT00596947|Primary|The Number of Participants With Graft Survival|The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.|6 and 12 months|data not interpretable due to low patient enrollment||||||
1238300|NCT00596947|Secondary|Participant Renal Function as Measured by 24 Hour Urine Collection|Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function.|3 and 12 months post-transplant|Unable to interpret data due to low number of patients enrolled.||||||
1238301|NCT00596947|Secondary|Participant Renal Function as Measured by MDRD Formula|The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant.|3, 6 and 12 months|Unable to interpret data due to low number of patients enrolled.||||||
1238302|NCT00596947|Secondary|The Length of Stay Associated With Hospital Readmissions|The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
1238303|NCT00596947|Secondary|The Number of Participants With Hospital Readmissions|The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
1238304|NCT00596947|Secondary|Length of Hospital Stay After Transplant|The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.|12 months|unable to interpret results due to low number of patients enrolled.||||||
1238305|NCT00596947|Secondary|The Number of Participants With Treatment Failures|This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial)|12 months|Unable to interpret data due to low number of patients enrolled.||||||
1238306|NCT00596947|Primary|The Number of Participants With Acute Rejection Episodes|Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.|6 and 12 months post-transplant|data not interpretable due to low patient enrollment||||||
1238307|NCT00596934|Secondary|Insulin Resistance: Homeostatic Model Assessment (HOMA) at 12 Months|HOMA values in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||mU/L x mg/dL||Standard Deviation|Mean
1238308|NCT00596934|Secondary|Fasting Triglycerides Value at 12 Months|Fasting triglyceride value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||mg/dL||Standard Deviation|Mean
1238312|NCT00596934|Secondary|Liver Fat Percentage by Magnetic Resonance Imaging (MRI - Dixon Method) at 12 Months|For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs’) fractional fat content throughout the liver in a few breath-hold intervals.|1 year||||liver fat percentage||Standard Deviation|Mean
1238313|NCT00596934|Secondary|Body Weight at 12 Months|Body weight (kg) after one year of treatment on metreleptin for patients that completed 12 months of metreleptin treatment.|1 year|Subjects that completed 12 months of metreleptin treatment.|||kg||Standard Deviation|Mean
1238314|NCT00596934|Primary|Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months|Non-alcoholic steatohepatitis (NASH) score after approximately one year of treatment with metreleptin. Total NASH scores can range from 0 to 14. The higher the NASH score the more severe the liver disease.|1 year|Individuals who completed the year of metreleptin treatment and had follow-up liver biopsies after one year.|||units on a scale||Standard Deviation|Mean
1238315|NCT00596830|Secondary|Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels||Cycles 1 and 4 (predose) and at end of treatment|This study was terminated early due to futility. As such, these data were not analyzed.||||||
1238316|NCT00596830|Secondary|Number of Participants With Total Anti-drug Antibodies (ADA)|ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.|Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose|All participants who received figitumumab (CP-751,871).|||participants|||Number
1238317|NCT00596830|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab||Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose|This study was terminated early due to futility. As such, Cmin was not summarized.||||||
1238318|NCT00596830|Secondary|Maximum Observed Plasma Concentration (Cmax) for Figitumumab||Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose|This study was terminated early due to futility. As such, Cmax was not summarized.||||||
1238319|NCT00596830|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state."|Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.||||||
1238320|NCT00596830|Secondary|European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore these data were not analyzed.||||||
1238321|NCT00596830|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore these data were not analyzed.||||||
1238322|NCT00596830|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||percentage of participants||95% Confidence Interval|Number
1238323|NCT00596830|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).|At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
1238786|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Peripheral Vascular’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238324|NCT00596830|Primary|Overall Survival (OS)|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline until death, assessed monthly after end of treatment, up to 30 months|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
1238325|NCT00596817|Secondary|Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Week 24 of the double-blind period (Counted From Double-blind Baseline)|FAS; OC|||units on a scale||Standard Error|Mean
1238326|NCT00596817|Secondary|Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)||Week 24 of the double-blind period|FAS; OC|||percentage of patients|||Number
1238327|NCT00596817|Secondary|Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)||Week 24 of the double-blind period (Counted From Open-label Baseline)|FAS; OC|||percentage of patients|||Number
1238328|NCT00596817|Secondary|Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC|||units on a scale||Standard Error|Mean
1238329|NCT00596817|Secondary|Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC|||units on a scale||Standard Error|Mean
1238330|NCT00596817|Secondary|Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment|The Hamilton Depression Scale – 17 items (HAM-D-17) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 52. The higher the score, the more severe.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC|||units on a scale||Standard Error|Mean
1238331|NCT00596817|Secondary|Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment||Double-blind Baseline and Week 24 of the double-blind period|FAS; observed cases (OC)|||units on a scale||Standard Error|Mean
1238332|NCT00596817|Secondary|Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator||Within 64 weeks of the double-blind period|FAS|||percentage of patients who relapsed|||Number
1238333|NCT00596817|Primary|Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Within first 24 weeks of the double-blind period|FAS|||percentage of patients who relapsed|||Number
1238334|NCT00596752|Secondary|Cardiovascular Morbidity During the Course of the Study (up to 196 Days)|Cardiovascular morbidity is presented as number of subjects with myocardial infarction and/or stroke during the course of the study.|During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.|||participants|||Number
1238335|NCT00596752|Secondary|Cardiovascular Mortality During the Course of the Study (up to 196 Days)||During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.|||participants|||Number
1238336|NCT00596752|Secondary|All-cause Mortality During the Course of the Study (up to 196 Days)||During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.|||participants|||Number
1238337|NCT00596752|Secondary|Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment|The number of subjects with revascularization prior to or at 24 weeks after the end of study drug treatment is presented below.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 577 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
1238338|NCT00596752|Secondary|Minor Amputations at 24 Weeks After the End of Study Drug Treatment|"Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.~The number of subjects with minor amputation prior to or at 24 weeks after the end of study drug treatment is presented below."|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 613 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
1238339|NCT00596752|Secondary|Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment|Systolic pressure at ankle level was measured at the Arteria tibialis posterior and the Arteria dorsalis pedis. Two individual series of measurements of arterial pressures per subject across the assessed visits were selected for the analysis. For the first analysis (worst change analysis) the series of measurements in the one artery which has the worst change from Baseline at the final measurement was used. For the second analysis (worst value analysis) the series of measurements which has the worst final post-Baseline measurement was used. The series relevant for the analyses was selected from the series for the affected leg or legs only. The selection is 1 out of up to 4 series available per subject. Series without Baseline value and series with at least 1 measurement of more than 150 mmHg were excluded from the selection process due to the suspicion of media sclerosis of the lower limb artery.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||mmHg||Standard Deviation|Mean
1238340|NCT00596752|Secondary|Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)|The number of subjects who used analgesics are summarized for different time points/intervals during the course of the study.|During the course of the study (up to 196 days)|Full Analysis Set (FAS) consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
1238341|NCT00596752|Secondary|Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment|In case of two ulcers the worse ulcer status is analyzed. The categories of investigator assessment are: complete healing, decrease by ≥ 50 %, unchanged, increase by ≥ 50 %.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 465 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
1238342|NCT00596752|Secondary|Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment|Visit values of intensity of rest pain from a visual analogue scale, ranging from 0 mm (no pain) to 100 mm (maximum conceivable pain), had to be reported in the case of presence of rest pain only. If the leading question in regard to the presence of rest pain is answered with “No“ and no visit value is specified, the visit value will be set to 0 for the analysis.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||millimeters (mm)||Standard Deviation|Mean
1238343|NCT00596752|Secondary|Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment|The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 568 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
1238344|NCT00596752|Primary|Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment|Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
1238345|NCT00596752|Primary|Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment|The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.|At 12 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
1238346|NCT00596687|Primary|Mean Blood Glucose Concentration|blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment|hospital stay days 2-10||||mg/dl||Standard Deviation|Mean
1238347|NCT00596687|Secondary|# Participants With Hypoglycemic Events|number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl)|hospital stay days 2-10||||participants|||Number
1238348|NCT00596635|Primary|Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.|Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.|6 months||||Urine cultures|||Number
1238349|NCT00596635|Secondary|Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture|Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had >100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.|6 months||||Participants|||Number
1238350|NCT00596635|Secondary|Number of Participants With E.Coli Isolated From Urine Culture|Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.|6 months||||Participants|||Number
1238352|NCT00596622|Primary|17-item Hamilton Depression Rating Scale (HDRS)|17-item HDRS is gold standard for measurement of depression with a range from 0 - 52. 10 - 14: mild depression; 14-20 moderate depression; >20: severe and very severe depression.|Measured at Baseline and after 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
1238353|NCT00596466|Primary|Number of Participants With Laboratory Test Values of Potential Clinical Importance|Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.|Baseline up to Week 28|Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study.|||Participants|||Number
1238354|NCT00596466|Primary|Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to Week 28|Safety analysis set population: all participants who received at least 1 dose of pregabalin.|||Participants|||Number
1238355|NCT00596466|Primary|Seizure Frequency||Baseline up to Week 28|Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study.||||||
1238356|NCT00596453|Primary|PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy)|"We took 4 Prostate Specific Antigen (PSA, ng/mL) measurements per participant. The first PSA test was performed at enrollment. The second PSA test was performed 7 days (+/-3 days) later. Then the participants took the Placebo or Cipro for 14 days. The participants returned for their 3rd PSA test upon completion of the Placebo or Cipro. The final PSA test was performed 7 days (+/-3 days) after the 3rd test.~We planned to compare the differences between the first two PSA tests and the last two PSA tests in the Placebo vs Cipro groups."|1 month post enrollment||||ng/mL||Standard Deviation|Mean
1238357|NCT00596440|Secondary|Show Rate at First Treatment Session||week one|This analysis includes only a subset of participants who had not discontinued the study by week 1.|||participants|||Number
1238358|NCT00596440|Secondary|Smoking Cessation Rate||week nine|The 129 participants represents a subset of the sample that participated in treatment. This subset of participants includes only those who attended eligibility session and participated in the week 9 follow-up. One oncology relative became ineligible immediately following completion of this counseling session and was excluded.|||participants|||Number
1238359|NCT00596440|Primary|Accrual Rate (Eligibility Visit)|Show rate to eligibility visit|week zero||||participants|||Number
1238360|NCT00596427|Secondary|Glucagon AUC|"Changes from baseline of glucagon AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks||||picograms (pg)/milliter (ml) x min||Standard Error|Mean
1238361|NCT00596427|Secondary|Postprandial Fractional Cholic Acid Synthesis|Changes from baseline in fractional cholic acid synthesis after 12 weeks of colesevelam or placebo treatment were evaluated. Fractional cholic acid synthesis represents the relative amount of cholic acid that is made from newly synthesised cholesterol.|baseline and 12 weeks||||Percent new cholic acid||Standard Error|Mean
1238362|NCT00596427|Secondary|Fasting Fractional Cholesterol Synthesis|Changes from baseline in fasting fractional cholesterol synthesis after 12 weeks of colesevelam or placebo treatment. Fractional Cholesterol synthesis represents the fraction of free cholesterol in plasma that was newly synthesised.|baseline and 12 weeks||||Percent new cholesterol||Standard Error|Mean
1238363|NCT00596427|Secondary|Fasting Fractional De Novo Lipogenesis (DNL)|Changes from baseline in fasting fractional DNL after 12 weeks of colesevelam or placebo treatment were calculated. Fractional DNL represents the fraction of palmitate in very-low density lipoproteins-triglycerides (VLDL-TG) that was newly synthesized.|baseline and 12 weeks||||percent new palmitate||Standard Error|Mean
1238364|NCT00596427|Primary|Rate of Appearance of Exogenous Glucose (Glucose Absorption)|Change from baseline of the rate of appearance of oral glucose after 12 weeks of placebo or colesevelam treatment. Mean of values obtained between 0 and 300 min is reported.|baseline and 12 weeks||||µmol per kg FFM per minute (min)||Standard Error|Mean
1238365|NCT00596427|Primary|Fasting Glycogenolysis|Change from baseline of fasting glycogenolysis after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks||||µmol per kilograms (kg) FFM per min||Standard Error|Mean
1238366|NCT00596427|Primary|Fasting Gluconeogenesis|Change from baseline of fasting gluconeogenesis after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks||||micromoles (µmol) per kg FFM per min||Standard Error|Mean
1238367|NCT00596427|Other Pre-specified|Glucose AUC|"Changes from baseline of glucose AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks||||millimoles (mmol)/l x min||Standard Deviation|Mean
1238368|NCT00596427|Other Pre-specified|Glycosylated Hemoglobin (HbAlc)|Changes from baseline of HbA1c after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks||||percentage||Standard Deviation|Mean
1238369|NCT00596427|Primary|Fasting Endogenous Glucose Production (EGP)|Changes from baseline of fasting EGP after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks||||umol per kg Fat-Free Mass (FFM) per min||Standard Error|Mean
1238370|NCT00596427|Secondary|Total Glucose-dependent Insulinotropic Polypeptide (GIP) AUC|"Changes from baseline of total GIP-1 AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
1238371|NCT00596427|Secondary|Total Glucagon-like Peptide (GLP-1) Area Under the Curve (AUC)|"Changes from baseline of total GLP-1 AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks||||picomoles (pmol)/Liter (L) x minute (min||Standard Deviation|Mean
1238393|NCT00595959|Post-Hoc|Walking Impairment Questionare (WIQ)|Measures difficulty in walking before and after treatment. Defined by comparing the responses to a WIQ at pre-treatment with the responses at 30 days, six (6) months and 12 months post-procedure. Higher score is better (scale 0-100).|measured at each follow-up period|65 patients at baseline and 30 days; 64 at 6 mo; 63 at 12 mo|||units on a scale 0-100||Standard Deviation|Mean
1238372|NCT00596362|Primary|The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease|At conclusion of study, up to 5 days||||participants|||Number
1238373|NCT00596271|Primary|GMT for Hepatitis A Virus (HAV) Antibody at Day 28||Day 28||||titers||95% Confidence Interval|Geometric Mean
1238374|NCT00596271|Secondary|Safety|Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)|until 6 month after last vaccination|||||||
1238375|NCT00596271|Secondary|GMT and SCR for PRNT at Day 28 and HAV at Day 56||day 28 and 56|||||||
1238376|NCT00596271|Secondary|Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28||day 28 and 56|||||||
1238377|NCT00596271|Primary|Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies|"anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to Outcome 2 within outcome measure section"|Day 56|Per Protocol Population includes all randomized subjects without major protocol deviations|||titers||95% Confidence Interval|Geometric Mean
1238378|NCT00596167|Primary|Intradialytic Clearance of Levofloxacin, Gentamicin and Vancomycin in Patients Receiving Short-daily Hemodialysis|"The intradialytic clearance of levofloxacin, gentamicin and vancomycin will be determined in patients receiving short-daily hemodialysis.~(Of important note, due to technical issues the levofloxacin data was not able to be used for the analysis. Only the gentamicin and vancomycin data was analyzed.)"|Serum concentrations for each drug will be determined from blood samples at 0 (pre-infusion), 30, 60 minutes (end of infusion).||||ml/min||Full Range|Median
1238379|NCT00596102|Secondary|Adverse Events||6, 12, 24, 36, 48 and 60 months after 1st vaccination|||||||
1238380|NCT00596102|Secondary|Geometric Mean Titers||6, 12, 36, 48 and 60 months|||||||
1238381|NCT00596102|Secondary|Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)||6, 12, 36, 48 and 60 months after 1st vaccination|||||||
1238382|NCT00596102|Primary|Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)|first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302|24 months after the first vaccination|subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study|||percentage of subjects||95% Confidence Interval|Number
1238383|NCT00596011|Other Pre-specified|Effect of Polyphenon E on the Fundamental Molecular Pathways|Explore the effects of Polyphenon E on the fundamental molecular pathways contributing to chemopreventive activity of Polyphenon E in the prostate. This exploratory aim is ongoing.|12 months|||||||
1238384|NCT00596011|Other Pre-specified|Change in Scores - Lower Urinary Tract Symptom (LUTS)|Change in score from baseline to 1 year. LUTS represent a common conglomeration of storage, voiding, and post-micturition symptoms with reported debilitating effect on quality of life. Symptom severity related to urinary frequency, nocturia, weak urinary stream, hesitancy, intermittency, incomplete bladder emptying and urinary urgency are assessed. We utilized the American Urological Association Symptom Score for the evaluation LUTS in this patient population. Symptom Frequency Scores: 0 = Not at all, 1 = Less than 1 time in 5, 2 = Less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. Total Symptom Score = Sum of individual scores of the 7 symptoms. (minimum possible score=0; maximum possible score =35; Range of scores and significance: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms.|1 year|Participants with LUTS symptom scores available at baseline and at one year|||units on a scale||Standard Deviation|Mean
1238385|NCT00596011|Secondary|Median Serum Total Prostatic Specific Antigen (tPSA)|Median ng/mL serum tPSA post treatment, per treatment arm.|12 months|All participants|||ng/mL||95% Confidence Interval|Median
1238386|NCT00596011|Secondary|Occurrence of Grade 3 or Higher Adverse Events (AEs)|Number of participants with AEs grade 3 or higher, per treatment arm.|12 months|All participants|||participants|||Number
1238387|NCT00596011|Secondary|Treatment Emergent Adverse Events (AEs)|Safety of Polyphenon E (200 mg EGCG bid for one year) in men with HGPIN or ASAP. Number of participants with AEs Possibly or Probably related to treatment.|12 months|All participants|||participants|||Number
1238388|NCT00596011|Primary|Rate of Progression From HGPIN to ASAP or PCa|Analyses of participants reaching a definitive endpoint. Number of baseline HGPIN participants who progressed to ASAP or PCa.|12 months|Baseline HGPIN participants|||participants|||Number
1238389|NCT00596011|Primary|Rate of Progression to Prostate Cancer (PCa)|Number of participants with diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP) who progressed to prostate cancer (PCa) at one year.|12 months|All participants|||participants|||Number
1238390|NCT00595959|Secondary|Volumetric Plaque Reduction|Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.|measured at time of procedure|Per protocol|||millimeters cubed||Standard Deviation|Mean
1238391|NCT00595959|Secondary|Adverse Events|Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.|Through 12 Months||||events|||Number
1238392|NCT00595959|Secondary|Rutherford Classification|Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst|Through 12 Months|63 at baseline; 62 at 30days and 6 months; 63 at 12 months|||units on a scale of 0-6||Standard Deviation|Mean
1238787|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Cardiovascular’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238394|NCT00595959|Secondary|Patients With >50% Stenosis Measured by Duplex Ultrasound|Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).|Through 12 Month|per protocol; 65 patients at 30 days; 59 at 6 months and 46 at 12 months|||percent of patients|||Number
1238395|NCT00595959|Secondary|Assisted Secondary Patency|Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site|Through 12 Month|65 at 30 days; 64 at 6 months; 63 at 12 months|||% pts free from secondary patency|||Number
1238396|NCT00595959|Secondary|Assisted Primary Patency|Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion|Through 12 Months|65 at 30 days; 64 at 6 months; 63 at 12 months|||% pts free from assisted primary patency|||Number
1238397|NCT00595959|Secondary|Clinical Success|Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure|measured post discharge thorugh 12 Months follow-up|65 patients at 30 days; 59 at 6 months; 46 at 12 months|||percent of patients|||Number
1238398|NCT00595959|Secondary|Minimum and Maximum Lumen Diameters|Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).|measured at time of procedure|Analysis per protocol|||millimeters||Standard Deviation|Mean
1238399|NCT00595959|Secondary|Procedural Success|Acute procedural success, defined as achievement of </= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of </=30%.|measured at time of procedure|Per protocol. All enrolled patients|||percent with </=30% RS|||Number
1238400|NCT00595959|Primary|Major Adverse Events|The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.|From discharge through the 6 month follow-up||||events|||Number
1238401|NCT00595959|Primary|Laser Success|The primary efficacy endpoint is laser success, defined as achieving >/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.|Measured at time of procedure|Per protocol|||percent reduction||Standard Deviation|Mean
1238402|NCT00595946|Secondary|Treatment Effectiveness (Patient Reported Outcome)|Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12). Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.|Weeks 1-12||||units on a scale||Standard Deviation|Mean
1238403|NCT00595946|Secondary|Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity|Ratings over 12-week treatment period were averaged and difference from baseline score calculated; Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls); Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular.|Weeks 1-12||||units on a scale||Standard Deviation|Mean
1238404|NCT00595946|Secondary|Responder Rate|Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.|Up to 12 weeks||||participants|||Number
1238405|NCT00595946|Secondary|First Post-dose Spontaneous Bowel Movement|The number of participants that experienced first post-dose Spontaneous Bowel Movement at 24 and 48 hour of dose initiation.|24 and 48 hours post-dose||||participants|||Number
1238406|NCT00595946|Secondary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement Frequency|Average weekly Spontaneous Bowel Movement frequency rating was calculated from data collected from Week 1-12|Baseline, Week 12, and Weeks 1-12||||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
1238407|NCT00595946|Primary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement Frequency|Outcome analyzed for subjects without dose reduction prior to Week 8, per protocol-specified primary outcome.|Baseline and Week 8||||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
1238408|NCT00595920|Secondary|Evaluate Changes in Annualized Relapse Rate||Annually|||||||
1238409|NCT00595920|Secondary|Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression||Annually|||||||
1238410|NCT00595920|Primary|Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)|This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.|Annually|This extension study was discontinued due to financial constraints. No efficacy results are summarized due to the small number of patients who received full treatment and follow-up.||||||
1238426|NCT00595556|Secondary|Change in Number of Drinks Per Week by Week|This outcome measure represents the change in the total number of standard drinks per week (weekly data) from baseline to the end of week twelve. This was analyzed using weekly measurements from baseline to week 12 week of the study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).|baseline to the end of 12 weeks in treatment|The analysis was intention to treat and last observation carried forward|||drinks/week||Standard Deviation|Mean
1238427|NCT00595556|Primary|Weekly Rate of Change in Abstinent Days|This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).|baseline to the end of 12 weeks in treatment||||days/week||Standard Error|Mean
1238411|NCT00595881|Primary|Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone.|The sensitivity and specificity of clinical examination with the addition of bedside emergency ultrasound will be compared against that of clinical examination alone.The number of lesions determined to actually have a drainable fluid collection will serve as the denominator in the calculation of sensitivity, and the number of lesions correctly identified as having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.The number of lesions determined to not have a drainable fluid collection will serve as the denominator in the calculation of specificity, and the number of lesions correctly identified as not having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator. Significance will be defined as a 95% confidence interval surrounding the differences between the two groups for sensitivity and specificity that does not include 0.|18 mos|Assuming a baseline sensitivity of clinical exam alone similar to that previously published (86%), type 1 error rate 0.05, and intraclass correlation coefficient of 0.5 for lesions within patients, we estimated a sample size of 393 lesions would provide 80% power to detect at least a 9% difference in the sensitivity of CE+EUS compared to CE alone.|||Ratio as a percentage||95% Confidence Interval|Number
1238412|NCT00595868|Secondary|7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million|7 day point prevalent abstinence 6 months after enrolling in the study was determined by two steps: (1) A report of no days of smoking for the 7 days prior to the 6 month on the Time Line Follow Back obtained at a telephone call 6 months after enrollment; (2) Those who reported no smoking for the prior 7 days came to our lab for breath carbon monoxide (CO) measurement to confirm abstinence. Breath CO had to be less than 10 parts per million for the participant to be classified as abstinent.|6 months||||participants|||Number
1238413|NCT00595868|Primary|Number of Participants With a Quit Attempt|A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.|6 months||||participants|||Number
1238414|NCT00595790|Secondary|Safety|AEs, Local and systemic tolerability, Safety laboratory parameters|Study duration|||||||
1238415|NCT00595790|Secondary|GMT at Day 10, 28, 35 and 56||Day 10, 28, 35 and 56|||||||
1238416|NCT00595790|Secondary|SCR at Day 10, 28 and 35||Day 10, 28 and 35|||||||
1238417|NCT00595790|Primary|SCR (Seroconversion Rate) at Day 56|Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer|day 56|The Participant Flow shows all study participants randomized. The Primary Outcome is based on the Per-Protocol-Population (all randomized subjects without major protocol deviation|||percentage of participants||95% Confidence Interval|Number
1238418|NCT00595764|Secondary|Overall Health- Short Form (36) Health Survey|"Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales.~The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning."|6 months|All participants who completed 1 or more SF-36 assessments were included in the analysis.|||Scores on a scale||Standard Error|Mean
1238419|NCT00595764|Secondary|Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.|The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.|6 months|All participants who completed one or more ASI assessments were included in the analysis.|||Scores on a scale||Standard Error|Mean
1238420|NCT00595764|Secondary|Cocaine Abstinence|Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.|6 months|All participants provided one or more urine screens thus data was based on all participants.|||weeks of abstinence||Standard Deviation|Mean
1238421|NCT00595764|Secondary|Treatment Completion|The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks.|6 months|All participants who entered treatment were evaluated for treatment completion.|||participants|||Number
1238422|NCT00595764|Primary|Illicit Opioid Abstinence|number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.|6 months|Repeated measures analysis of variance was used to evaluate differences between groups in the maximum number of consecutive weeks of opioid abstinence for the first and second 12 weeks of treatment. We coded missing urine specimens as positive for opioids in our analysis, thus all participants provided data.|||Weeks of Abstinence||Standard Deviation|Mean
1238423|NCT00595582|Primary|Neuropsychological Scores in Patients With MCI or Mild AD.||within the next three years|No data were collected as this study was terminated.|||units on a scale||Standard Deviation|Mean
1238424|NCT00595556|Secondary|Change in Gamma-glutamyl Transferase (GGT) Concentration|This outcome measure looks at the change in blood levels of this enzyme assay from baseline, and then after 6 weeks (midpoint), and then at the endpoint (12 weeks). The analysis takes into account all three time points, and reports the average change between each of the three time points.|12 weeks (from initiation to end of treatment)||||Units/Liter||Standard Deviation|Mean
1238425|NCT00595556|Secondary|Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)|This is the change in measured urge to drink alcohol as measured by the Alcohol Urge Questionnaire (AUQ), measured every 2 weeks from baseline until the last week of the study (over twelve weeks, 7 timepoint measurements of AUQ, 6 calculated changes). It is reported in terms of change per visit (every 2 weeks). AUQ measures a feeling state, and uses a 7 point (1-7)Likert scale for each of 8 items (questions). The lowest urge score is 8 (representing less urge to drink), and the highest would be tabulated as 56 (meaning more urge to drink). Repeated measures SPPS linear mixed models used.|baseline to the end of 12 weeks in treatment||||units on a scale/visit||Standard Deviation|Mean
1238466|NCT00595270|Secondary|SCR 1 Month After the Booster Doses||1 month|||||||
1238467|NCT00595270|Secondary|Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination||24 months|||||||
1238428|NCT00595556|Primary|Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week|This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).|baseline to the end of 12 weeks in treatment||||Days/week||Standard Deviation|Mean
1238429|NCT00595530|Secondary|Self-reported Pain Scores||Every 4 hours|||||||
1238430|NCT00595530|Secondary|Intravenous Opiate Utilization||Every 4 hours|||||||
1238431|NCT00595530|Primary|The Number of Participants That Experience Side Effects|How many participants experienced side effects while undergoing treatment with the study drug?|Daily while inpatient and once a week for first 4 weeks post discharge||||participants|||Number
1238432|NCT00595517|Primary|Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period||up to 52 weeks||||Participants|||Number
1238433|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment||up to 24 weeks after treatment||||participants|||Number
1238434|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment||up to 12 weeks after treatment||||participants|||Number
1238435|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment||up to 4 weeks after treatment||||Participants|||Number
1238436|NCT00595504|Primary|Change in Abdominal Fat (DEXA).|A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.|||g||Standard Deviation|Mean
1238437|NCT00595504|Primary|Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).|A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.|||HOMA score||Standard Deviation|Mean
1238438|NCT00595504|Primary|Change in Waist Circumference|A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.|||cm||Standard Deviation|Mean
1238439|NCT00595478|Secondary|Days of Alcohol Use During 36-week Follow-up Period|Percentage of days alcohol used during the 36-week follow-up period after treatment ended measured via timeline follow-back.|Monthly up to 9 months (36 weeks)|The analysis population consisted of only participants with follow-up (alcohol use) data on at least 85% of the days in the 36-week follow-up period.|||percentage of days used||Standard Deviation|Mean
1238440|NCT00595478|Primary|Alcohol Abstinence|Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)|Weekly up to 14 weeks||||Samples||Standard Deviation|Mean
1238441|NCT00595465|Secondary|Safety and Adverse Events||Day 56|||||||
1238442|NCT00595465|Secondary|Seroconversion Rate||Day 56|||||||
1238443|NCT00595465|Primary|Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody||Day 56|Per Protocol Population (PP Population, N= 364): includes all subjects randomized who received at least one dose of study medication without any major protocol violations identified at the blind data review meeting.|||titers||Standard Deviation|Mean
1238444|NCT00595413|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38|ITT population included all randomized participants who received at least 1 study treatment dose.|||participants|||Number
1238445|NCT00595413|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Responses at Week 26|The EULAR response criteria evaluate change in DAS28 scores represented as “good response”, “moderate response”, or “no response” considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have “good” or “moderate” EULAR response if at the time of assessment, their DAS28 score was less than or equal to (<=) 5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2.|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.|||percentage of participants|||Number
1238446|NCT00595413|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26|ACR70-CRP response is defined as >=70% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.|||percentage of participants|||Number
1238447|NCT00595413|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26|ACR50-CRP response is defined as >=50% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.|||percentage of participants|||Number
1238448|NCT00595413|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26|ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.|||percentage of participants|||Number
1238449|NCT00595361|Secondary|Comparison of the Maximum Percent Fall in FEV1 After 1st Dose of Salmeterol to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects||2 weeks after 1st dose of Salmeterol||||% fall FEV1||Standard Deviation|Mean
1238450|NCT00595361|Secondary|Comparison of the Maximum Percent Fall in FEV1 From Pre-salmeterol Baseline to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients||2 weeks from pre-salmeterol baseline||||% fall FEV1||Standard Deviation|Mean
1238451|NCT00595361|Primary|Comparison of the Maximum Percent Fall in FEV1 After Exercise Challenge at the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients||2 weeks after exercise challenge||||% fall FEV1||Standard Deviation|Mean
1238452|NCT00595335|Secondary|Failure Rate at One Year|The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.|one year|Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 52 weeks.|||percentage of participants|||Number
1238453|NCT00595335|Secondary|Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey|Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.|baseline, 6 months after first infusion, 12 months after first infusion||||units on a scale||Inter-Quartile Range|Median
1238454|NCT00595335|Secondary|Change in Extraocular Motility|"Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object.~The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant)."|baseline, 6 months after first infusion, 12 months after first infusion|Intention to treat analysis|||units on a scale||Inter-Quartile Range|Median
1238455|NCT00595335|Secondary|Change in Lid Fissure|"The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease.~Improvement was defined as a decrease in lid aperture width by ≥3 mm."|baseline, 6 months after first infusion|Intention to treat analysis|||mm||Inter-Quartile Range|Median
1238456|NCT00595335|Secondary|Change in Proptosis|Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm.|baseline, 12 months after first infusion||||mm||Standard Deviation|Mean
1238457|NCT00595335|Secondary|Change in Disease Severity|Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0–6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is based on the first letter of the defining characteristic of each class, the classification is known as: ‘no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss’ (NOSPECS) ).|baseline, 6 months after first infusion|Intention to treat analysis|||participants|||Number
1238458|NCT00595335|Secondary|Failure Rate|The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.|6 months after first infusion, 12 months after first infusion|Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 24 weeks.|||percentage of participants|||Number
1238459|NCT00595335|Primary|Change in Clinical Activity Score (CAS)|The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease.|baseline, 6 months after the first infusion|Sample size was computed based on the expected drop of 2.9 and 1.5 points in the CAS score in rituximab and placebo groups. A sample size of 15 in each group will have 80% power to detect a difference in mean values of 1.4 assuming that the common standard deviation is 1.27 using a two group t-test with a 0.050 two-sided significance level.|||units on a scale||Standard Deviation|Mean
1238460|NCT00595309|Secondary|Geometric Mean Titer||D28, Month 6 and Month 12 after booster|||||||
1238461|NCT00595309|Secondary|Seroconversion||at D28 and Month 6 after booster|||||||
1238462|NCT00595309|Secondary|Safety and Adverse Events||up to Month 12 after booster|||||||
1238463|NCT00595309|Primary|Seroconversion Rate||at Month 12 after booster|Intent-To-Treat Population which includes all subjects entered into the study who received the booster vaccination|||percent||95% Confidence Interval|Number
1238464|NCT00595270|Secondary|Safety Profile of IC51||study duration|||||||
1238465|NCT00595270|Secondary|GMT 1month After Booster Doses||1 month|||||||
1238469|NCT00595270|Secondary|SPR 24 Months After the Primary Vaccination (Observed)|"Persistence of immunogenicity (SPR) at M24 (observed) defined as :~positive (persistent): Subjects~with a non-missing, positive seroconversion at D56 (Study IC51-304), and~who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and~with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and~with a non-missing, SP positive PRNT50 result at Visit 5 (M24)~negative (non-persistent): Subjects~with missing or negative seroconversion at D56 (Study IC51-304), or~who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or~with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or~with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or~with a non-missing, SP negative PRNT50 result at Visit 5 (M24)"|24 months|||||||
1238470|NCT00595270|Primary|Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination|"Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as:~pos. (positive) (persistent): Subjects~with a non-missing, pos. seroconversion at D56 (Study IC51-304) and~without booster at M11 or M23 and~with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and~with non-missing, SP pos. PRNT50 at M24~neg. (negative) (non-persistent): Subjects with~missing or neg. seroconversion at D56 (Study IC51-304) or~booster at M11 or at M23, or~non-missing, SP neg. PRNT50 at M6 or M12 or~missing PRNT50 at both M6 and M12 or~missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24"|- 24 months|ITT (Intent-To-Treat) Population: included all subjects rolled over from study IC51-304; analyzed according to treatment to which they were randomized in IC51-304|||percentage of participants||95% Confidence Interval|Number
1238471|NCT00595153|Primary|Gene Expression in Airway Secretions and Tissues|The primary outcome measure for this study is the scaled mean value of three gene expression markers of IL-13 in the airway: PERIOSTIN, calcium-activated chloride channel regulator 1 (CLCA1), and plasminogen activator inhibitor-2 (SERPINB2). First, for each of the three interleukin-13 (IL-13) signature genes, the log (base-2) transformed relative expression value for each subject is measured using real-time polymerase chair reaction (PCR) and normalized with the geometric mean of 5 housekeeping genes. Next, these values are centered (by subtracting the mean for that gene) and scaled (by dividing by the standard deviation for that gene) so that each gene makes an equal, assay-independent contribution to the Th2 phenotype. Then, for each subject, the arithmetic mean of the three centered & scaled genes is calculated, producing the “three-gene-mean” metric.|Healthy Control: Visit 2 (at 1 week); Steroid Naive Asthmatics: Visit 2 (at 1 week); Steroid Treated Asthmatics: Visit 5 (at 9 weeks)|"Participants who met inclusion/exclusion requirements and completed all study activities were included in the analysis. Specifically, this included:~1. Having a bronchoscopy with complete PCR on RNA from epithelial brush samples."|||Relative gene expression level||Standard Deviation|Mean
1238472|NCT00595127|Primary|Incidence & Quality of Engraftment & Hematopoietic Reconstitution|Number of patients who engrafted|8 years||||participants|||Number
1238473|NCT00595114|Primary|8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma|8-isoprostane levels in sputum|Measured at completion of sample analysis||||pg/ml||Standard Deviation|Mean
1238474|NCT00595088|Secondary|Safety|the incidence and severity of adverse events|9 weeks||||percentage of participants|||Number
1238475|NCT00595088|Secondary|Ablative Effect on a Marker Tumor|Complete disappearance of marker lesion|9 weeks||||percentage of participants||90% Confidence Interval|Number
1238476|NCT00595088|Secondary|Time to Tumor Recurrence|The Time to Tumor Recurrence is defined as the interval between the date of the final tumor resection before the start of study treatments to the date when the cystoscopy was performed in which it was confirmed by histopathology that any suspicious lesions that were observed, were TCC of the bladder with the exception of the continued presence of the marker tumor at Week 9|46 Weeks||||months||Full Range|Median
1238477|NCT00595088|Primary|Complete Tumor Response Defined as the Absence of New Tumors|Tumor response evaluated at week 9 (range 8-10 weeks) during the first post induction course treatment cystoscopy or TUR of suspiciaous lesions|9 Weeks|All patients who met the study inclusion and exclusion criteria; received all 6 of the induction course intravesical administrations of the investigational product; and had a follow-up cystoscopy during Weeks 8 to 10 and biopsy or TUR of suspicious lesions|||percentage of participants||90% Confidence Interval|Number
1238478|NCT00595075|Other Pre-specified|Psychomotor Vigilance Task - Number of Lapses|Number of trials per test battery with a reaction time >0.5 seconds (higher values indicate worse outcome)|8 hours|All participants completing both crossover periods|||lapses||Standard Deviation|Mean
1238479|NCT00595075|Other Pre-specified|Psychomotor Vigilance Task - Median Reaction Time|Visual-motor reaction time in which participants hit a button on a response box as fast as possible in response to a visual target (lower values indicate better outcome)|8 hours|All participants completing both crossover periods|||seconds||Standard Deviation|Mean
1238480|NCT00595075|Other Pre-specified|Post Nap Assessment - Karolinska Drowsiness Test|EEG spectral analysis of 5.5-9.0 Hz frequency activity (theta low-frequency alpha), with higher activity indicating increased drowsiness and worse outcome|71 minutes|All participants completing both crossover periods|||microvolts^2/Hz||Standard Deviation|Mean
1238481|NCT00595075|Other Pre-specified|Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers)|A cognitive throughput task consisting of matching symbols to numerical keys; higher numbers indicate a better score|71 minutes|All participants that completed both crossover periods|||correct answers||Standard Deviation|Mean
1238482|NCT00595075|Other Pre-specified|Post Nap Assessment - Karolinska Sleepiness Scale|numerical scale of increasing sleepiness from 1-9 (higher values indicate worse outcome)|71 minutes|All participants that completed both crossover periods|||units on a scale||Standard Deviation|Mean
1238483|NCT00595075|Other Pre-specified|Post-nap Assessment - Visual Analog Scale|numerical scale of increasing alertness from 0-100 (higher values are better outcome)|71 minutes|All participants that completed both crossover periods|||units on a scale||Standard Deviation|Mean
1238484|NCT00595075|Primary|Sleep Efficiency|total sleep time/time in bed * 100% (higher values indicate better outcome)|2 hours|All participants that completed both crossover periods|||percent||Standard Deviation|Mean
1238485|NCT00594958|Secondary|SCR for Anti-JEC Neutralizing Antibody Titer||day 56|||||||
1238486|NCT00594958|Secondary|Safety|Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability|study duration|||||||
1238487|NCT00594958|Primary|GMT for Anti-JEV Neutralizing Antibody|Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.|day 56|Per Protocol Population (observed values)|||GMT||95% Confidence Interval|Geometric Mean
1238488|NCT00594945|Primary|Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).|Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.|Change from baseline to treatment day||||percentage of baseline||Standard Deviation|Mean
1238489|NCT00594906|Primary|Healing of a Fracture From a Low Energy Fall|Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)|Measured at 16 weeks||||participants|||Number
1238490|NCT00594880|Secondary|HIV Viral Load < 400 Copies/ml|% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)|24 weeks|percent of consenting eligible participants (n=8) with VL < 400 at week 24 of treatment|||percentage of eligible participants|||Number
1238491|NCT00594880|Secondary|HIV Viral Load < 48 Copies/ml|% of individuals maintaining VL < 48 copies/ml while on pegylated interferon alpha-2a treatment without ART|12 weeks|% of subjects maintaining VL < 48 copies/ml after 12 weeks of treatment|||percentage of participants|||Number
1238492|NCT00594880|Primary|HIV Viral Load < 400 Copies/ml|% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)|12 weeks|excluded 2 withdrawal of consent and 1 lost to follow-up|||percentage of participants|||Number
1238493|NCT00594854|Secondary|Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score|The degree of upper gastrointestinal (UGI) injury as measured by Lanza scores (1991) during treatment with PN 400 and ARTHROTEC® in a high-risk population. The Lanza (1991) score is based on endoscopic obeservations and rating these, with no damage, petecchiae, erosions and ulcers. On the 1991 scale, a Lanza score of 0 represents normal mucosa (no damage), while a score of 4 indicates 6-10 erosions, and a score of 7 indicates an ulcer.|6 months||||participants|||Number
1238494|NCT00594854|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.|6 months||||Participants|||Number
1238495|NCT00594854|Secondary|Number of Participants With Duodenal Ulcers Confirmed by Endoscopy|Number of participants with duodenal ulcers confirmed by endoscopy following administration of PN 400 VIMOVO)or Arthrotec in a high risk population|6 months||||participants||95% Confidence Interval|Number
1238496|NCT00594815|Primary|Progression Free Survival|Overall Progression Free Survival at 2 years|2 Years||||percentage of participants||95% Confidence Interval|Number
1238497|NCT00594815|Primary|Total Number of Participants Who Experienced Acute Treatment Related Adverse Events|The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.|2 years||||Participants|||Count of Participants
1238498|NCT00594685|Secondary|Relationship Between the Presence of the Factor V Leiden Mutation or the Prothrombin 20210 Mutation and the Risk of Thrombosis|Analysis not performed since central laboratory tests were not done.|Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT|Analysis not performed since central laboratory tests were not done.||||||
1238499|NCT00594685|Post-Hoc|Time to First Asymptomatic or Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT|Since two versions of the data collection form were used in this study, and only the revised version contained information on whether the event was asymptomatic or symptomatic, a post-hoc analysis was performed which included all thromboses, whether symptomatic, asymptomatic, or of unknown type. Survival analysis was used.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT||||Days||Standard Error|Mean
1238500|NCT00594685|Secondary|Relationship Between PF4-heparin ELISA Test, Serotonin-release Assay, and D-dimer Test Results and Thromboembolism|Analysis not performed since central laboratory tests were not done.|Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT|Analysis not performed since central laboratory tests were not done.||||||
1238501|NCT00594685|Secondary|Relationship Between the Platelet Factor 4 (PF4)-Heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) Test, the Serotonin-release Assay, and D-dimer Test Results|Analysis not performed since central laboratory tests were not done.|Measured at Day 1|Analysis not performed since central laboratory tests were not done.||||||
1238502|NCT00594685|Secondary|Length of Hospital Stay (With Deaths Not Censored)|The length of time between the date of HIT diagnosis and first hospital discharge was calculated. Subjects were not censored at death. Survival analysis was used.|Measured upon hospital discharge|Two subjects were known to be readmitted to the hospital after initially being discharged.|||Days||Standard Error|Mean
1238503|NCT00594685|Secondary|Length of Hospital Stay|The length of time between the date of HIT diagnosis and first hospital discharge was calculated. Subjects were censored at death. Survival analysis was used.|Measured upon hospital discharge|Two subjects were known to be readmitted to the hospital after initially being discharged.|||Days||Standard Error|Mean
1238504|NCT00594685|Secondary|Number of Days That Medications Were Given to Participants at Participating Institutions|Per the protocol, descriptive statistics on the types and durations of therapeutic approaches used will be presented.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT||||Days medication was given||Full Range|Median
1238505|NCT00594685|Secondary|Time to Platelet Count Recovery|The time to platelet recovery was defined as the time from the nadir platelet count observed in the five days after the positive HIT test was sent to observing a platelet count of 100K or greater. Survival analysis was used.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|One subject's nadir platelet count was > 100K, so that subject is not included in the analysis.|||Days||Standard Error|Mean
1238506|NCT00594685|Secondary|Time Until Death From All Causes|The time until death from all causes, in days, was determined using survival analysis.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|One subject was censored at the time that the study was terminated.|||Days||Standard Error|Mean
1238788|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Dermatological’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238507|NCT00594685|Secondary|The Time to First Bleeding Event With Current Therapies for Isolated HIT|The time to first bleeding event was analyzed using survival analysis.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT||||Days||Standard Error|Mean
1238508|NCT00594685|Secondary|The Number of Participants With Incidental Arterial and Venous Thromboembolism (i.e., a Clot Diagnosed by Radiographic Tests Done for Reasons Other Than to Diagnose or Rule Out a Thromboembolic Event)|There were two versions of the data collection form used in this study, and only the revised form contained information on whether the event was incidental.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|Two subjects did not have information on whether the event was incidental. These subjects were censored in the analysis.|||Participants|||Number
1238509|NCT00594685|Secondary|The Number of Participants With Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT|There were two versions of the data collection form used in this study, and only the revised version collected information on whether the event was symptomatic.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|Two subjects did not have information on whether the event was symptomatic or asymptomatic. These two subjects were censored in the analysis.|||Participants|||Number
1238510|NCT00594685|Secondary|The Percentage of Participants With Asymptomatic Thrombosis 4 Weeks After the Diagnosis of Isolated HIT, Determined by Four-limb Ultrasound|The percentage of participants with asymptomatic thrombosis 4 weeks after the diagnosis of isolated HIT, determined by four-limb ultrasound, and 95% exact binomial confidence interval.|Measured at Day 35 (+/- 7days)|Four subjects had missing data for this endpoint (no ultrasound performed on end-of-study date) and are not included in this analysis.|||Percentage of participants||95% Confidence Interval|Mean
1238511|NCT00594685|Primary|The Percentage of Participants With Asymptomatic Thrombosis at the Time Isolated Heparin-Induced Thrombocytopenia (HIT) is Diagnosed, Determined by Four-limb Ultrasound|The percentage of participants with asymptomatic thrombosis at the time isolated HIT is diagnosed as determined by four-limb ultrasound.|Measured at Day 1||||Percentage of participants||95% Confidence Interval|Mean
1238512|NCT00594659|Primary|Point Prevalence Abstinence Post Treatment|Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).|9 months (from the end of treatment to 9 months post-treatment).|Intent to Treat|||pecentage of participants abstinent|||Number
1238513|NCT00594659|Primary|Consecutive Weeks of Marijuana Abstinence|Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.|From the start of treatment through the end of the active treatment period, i.e., 12 weeks.|Intent to Treat|||consecutive weeks of abstinence||Standard Deviation|Mean
1238514|NCT00594646|Primary|Number of HIV-1 Infected Participants|Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected|90 days|Participants evaluable at 3 months (90 days) after treatment initiation|||participants|||Number
1238515|NCT00594646|Primary|Medication Regimen Completion Rates|Pill counts performed at 14 and 28 days|28 days||||participants|||Number
1238516|NCT00594568|Secondary|Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1238517|NCT00594568|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1238518|NCT00594568|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug|RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1238519|NCT00594568|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges from 0 to 100; Lower score indicates greater disease severity. LS Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1238597|NCT00594386|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|6 years|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
1238520|NCT00594568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1238521|NCT00594568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1238522|NCT00594568|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug|Semi-structured interview; Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains. Total score (SB) ranges: 0 to 18; Higher scores=greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1238523|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238524|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238525|NCT00594568|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||hospitalizations/participant||Standard Error|Least Squares Mean
1238526|NCT00594568|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver’s impression of participant’s overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238527|NCT00594568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238528|NCT00594568|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant’s cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238529|NCT00594568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The total score ranges from 0 to 30; Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238530|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238531|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238532|NCT00594568|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of volume of distribution.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
1238533|NCT00594568|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of clearance.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1238534|NCT00594568|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1238535|NCT00594568|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||ratio||Standard Error|Least Squares Mean
1238536|NCT00594568|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
1238537|NCT00594568|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||ratio||Standard Error|Least Squares Mean
1238538|NCT00594568|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1238844|NCT00593450|Secondary|Area of Lesion Change From Baseline||Baseline and 1 Year||||mm^2||Standard Deviation|Mean
1238539|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant’s caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238540|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant’s caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238541|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug|ADAS‑Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238542|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks|ADAS‑Cog11 was used as a primary efficacy measure. It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1238543|NCT00594516|Secondary|Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.|Average total daily dose (TDD) of tapentadol ER during the double-blind treatment period.|14 days for each treatment period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.|||mg||Standard Deviation|Mean
1238544|NCT00594516|Secondary|Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period|Average total daily dose (TDD) of tapentadol IR during the double blind treatment period|14-day for each DB treatment period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.|||mg||Standard Deviation|Mean
1238545|NCT00594516|Secondary|The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment||14 days for each cross-over period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.|||participants|||Number
1238546|NCT00594516|Secondary|The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment||14 days for each cross-over period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.|||participants|||Number
1238547|NCT00594516|Primary|The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences)|"For this twice daily pain assessment, the subjects were to indicate the level of average pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|14 days for each cross-over period|Per-protocol set defined as the number of randomized subjects who took at least one dose of study drug during the DB treatment period, and who met additional criteria which were identified prior to unblinding.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1238548|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.|Questionnaire including 3 items Range of sum score: 3 to 18 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Therapy with patch was easily feasible Item 2: Symptoms of Parkinson’s Disease were well controlled Item 3: I felt safe with the Parkinson patch|2 weeks after surgery|Full Analysis Set (Subjects having valid data for all three feasibility assessments)|||Score on scale||Standard Deviation|Mean
1238549|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.|Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Switch to patch was easily feasible Item 2: Re-switch was easily feasible Item 3: Patient did not show unexpected symptoms Item 4: Patch is a feasible option|2 weeks after surgery|Full Analysis Set (Subjects having valid data for all three feasibility assessments)|||Score on scale||Standard Deviation|Mean
1238550|NCT00594464|Secondary|Plasma Concentration of Rotigotine After Use.||24 hours|Pharmacokinetic Set (Subjects for whom a blood sample for determination of the plasma concentration of rotigotine was drawn and a valid determination of the plasma concentration could be done)|||ng/ml||Standard Deviation|Mean
1238598|NCT00594386|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|6 years|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
1238551|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.|Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Patient did not show unexpected symptoms Item 2: Handling was simple Item 3: Handling wasn’t time-consuming Item 4: Patch is a considerable option|After subject wakes up from general anesthesia|Full Analysis Set (Subjects having valid data for all three feasibility assessments)|||Score on scale||Standard Deviation|Mean
1238552|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||12 weeks after last treatment|Safety|||percentage of participants|||Number
1238553|NCT00594425|Primary|Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||12 weeks|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||lesions||95% Confidence Interval|Least Squares Mean
1238554|NCT00594425|Primary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||12 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||percentage of participants|||Number
1238555|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||6 weeks after last treatment|Safety|||percentage of participants|||Number
1238556|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment||2 weeks after first treatment|Safety|||percentage of participants|||Number
1238557|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||2 weeks after last treatment|Safety|||percentage of participants|||Number
1238558|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment||2 days after first treatment|Safety|||percentage of participants|||Number
1238559|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||12 weeks after last treatment|Safety|||percentage of participants|||Number
1238560|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||6 weeks after last treatment|Safety|||percentage of participants|||Number
1238561|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||2 weeks after last treatment|Safety|||percentage of participants|||Number
1238562|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment||2 weeks after first treatment|Safety|||percentage of participants|||Number
1238563|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment||2 days after treatment|Safety|||percentage of participants|||Number
1238564|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Fourth Treatment||immediately after fourth treatment|Safety|||percentage of participants|||Number
1238565|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Third Treatment||immediately after third treatment|Safety|||percentage of participants|||Number
1238566|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Second Treatment||immediately after second treatment|Safety|||percentage of participants|||Number
1238567|NCT00594425|Secondary|Proportion of Patients With Severe Erythema 7 Days After First Treatment||7 days after first treatment|Safety|||percentage of participants|||Number
1238568|NCT00594425|Secondary|Proportion of Patients With Severe Erythema 2 Days After First Treatment||2 days after first treatment|Safety|||percentage of participants|||Number
1238569|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After First Treatment||immediately after first treatment|Safety|||percentage of participants|||Number
1238570|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment||immediately after fourth treatment|Safety|||percentage of participants|||Number
1238571|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Third Treatment||immediately after third treatment|Safety|||percentage of participants|||Number
1238572|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Second Treatment||immediately after second treatment|Safety|||percentage of participants|||Number
1238573|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After First Treatment||2 days after first treatment|Safety|||percentage of participants|||Number
1238574|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After First Treatment||immediately after first treatment|Safety|||percentage of participants|||Number
1238575|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after illumination-fourth treatment treatment|Safety|||cm||Full Range|Median
1238576|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after third treatment|Safety|||cm||Full Range|Median
1238577|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after second treatment|Safety|||cm||Full Range|Mean
1238578|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after illumination-first treatment|Safety|||cm||Full Range|Median
1238599|NCT00594308|Secondary|Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.|Number of patients who died due to transplant related toxicities|up to 2 years after stem cell transplant|Intent To Treat: All patients that received study drug|||participants|||Number
1238579|NCT00594425|Secondary|The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment||12 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||percentage of participants|||Number
1238580|NCT00594425|Secondary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Precentage of participants|||Number
1238581|NCT00594425|Secondary|Percent Reduction in Total Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Percentage change||Full Range|Median
1238582|NCT00594425|Primary|Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts||12 weeks after last treatment|ITT population|||lesions||95% Confidence Interval|Least Squares Mean
1238583|NCT00594425|Primary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||12 weeks after last treatment|ITT population|||Percentage of participants||95% Confidence Interval|Number
1238584|NCT00594425|Secondary|Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Percentage change||Full Range|Median
1238585|NCT00594425|Secondary|Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Percentage change||Full Range|Median
1238586|NCT00594425|Secondary|Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||3 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Percentage change||Full Range|Median
1238587|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|12 Months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.|||minutes per week||Standard Deviation|Mean
1238588|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|3 months||||minutes per week||Standard Deviation|Mean
1238589|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|Baseline||||minutes per week||Standard Deviation|Mean
1238590|NCT00594399|Primary|12 Month Fasting Glucose||12 Months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.|||mg/dl||Standard Deviation|Mean
1238591|NCT00594399|Primary|3 Month Fasting Glucose||3 months||||mg/dl||Standard Deviation|Mean
1238592|NCT00594399|Primary|Fasting Glucose||Baseline||||mg/dl||Standard Deviation|Mean
1238593|NCT00594399|Primary|12 Month Fasting Insulin||12 months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.|||uIU/ml||Standard Deviation|Mean
1238594|NCT00594399|Primary|3 Month Fasting Insulin||3 month||||uIU/ml||Standard Deviation|Mean
1238595|NCT00594399|Primary|Fasting Insulin|Fasting Insulin analyzed at VA central laboratory by technicians not affiliated with study. Participants were instructed to refrain from eating or drinking anything except water and medications past midnight. A reminder call was placed the night before the scheduled appointment and fasting was verified by study personnel before appointed blood draws.|Baseline||||uIU/ml||Standard Deviation|Mean
1238596|NCT00594386|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.|||Score on a scale||Standard Deviation|Mean
1238632|NCT00594035|Primary|Watertight Dural Closure|Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.|Intra-Operative||||Participants|||Number
1238600|NCT00594308|Secondary|Time to Resolution of Cytopenias: Platelet Transfusion Independence|Average number of days per patient for resolution of cytopenias.|From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)|IIT: All patients that received study drug.|||days per patient||Standard Deviation|Mean
1238601|NCT00594308|Secondary|Number of Days for Absolute Neutrophil Count to Recover|Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).|From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)|ITT: All patient that received study drug|||days per patient||Standard Deviation|Mean
1238602|NCT00594308|Secondary|Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).||until 30 days after stem cell transplant|ITT population. All patient that received study drug|||participants|||Number
1238603|NCT00594308|Primary|Number of Patients With Acute Grade II-IV GVHD|Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.|until 30 days after stem cell transplant|All patient that received study drug|||participants|||Number
1238604|NCT00594256|Secondary|Slow Wave Sleep Minutes|Overnight sleep study: Subjects will undergo polysomnography four times during this study, on consecutive nights during the observation week and on consecutive nights at the end. Polysomnography will be performed in a modified seclusion room on the in patient unit. The first of the consecutive nights will be used for adaptation to the study conditions. Sleep was recorded between lights off (10 pm) and lights on (at 6:45 am). We aim for conditions for falling asleep as comfortable as possible under the experimental condition.|1 month|4 pre post|||minutes||Standard Deviation|Mean
1238605|NCT00594256|Secondary|MATRICS Neurocognitive Battery Composite|This is a series of neurocognitive tests developed by the National Institute of Mental Health to evaluate medications targeting cognition in an efficient and reliable manner. It will be modified by the deletion of the social competence domain. The six domains include speed of processing, attention/vigilance, working memory, verbal learning, visual learning and reasoning/problem solving. The primary outcome will be the mean T-score (mean of six domains).|1 month||||Composite T-score||Standard Deviation|Mean
1238606|NCT00594256|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Factor|The PANSS Negative factor is a 7-item rating scale widely used in the assessment of schizophrenia. Range is 7-49 with higher scores worse|1 month|Paired t test of baseline and final values|||mean decrease in negative subscale||Standard Deviation|Mean
1238607|NCT00594256|Primary|Epworth Sleepiness Scale|Designed to measure daytime sleepiness. 8 items rated 0-3, with higher scores associated with a greater daytime sleepiness. overall score rated 0-24, with scores greater than 10 indicating significant daytime sleepiness.|1 month||||global score||Standard Deviation|Mean
1238608|NCT00594256|Primary|Pittsburgh Sleep Quality Index|This rating scale generates a global sleep-quality score, as well as scores on 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 19 items are combined to form seven “component” scores, each of which has a range of O-3 points. The seven component scores are then added to yield one “global” score, with a range of O-21 points, “0” indicating no difficulty and “21” indicating severe difficulties in all areas.|1 month|ITT|||global score||Standard Deviation|Mean
1238609|NCT00594230|Secondary|Safety and Tolerability of LBH589 in Patients With Relapsed/Refractory MDS|NOTE: Study terminated early, no results are available for this endpoint|24 months|||||||
1238610|NCT00594230|Secondary|Median Overall Survival|"The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death~NOTE: Study terminated early, no results are available for this endpoint"|24 months on-study, patients followed every 3 months in follow-up|||||||
1238611|NCT00594230|Secondary|Median Time to Treatment Failure|"Time to treatment failure is defined as measuring the time between cycle 1 day 1 to discontinuation for any reason.~NOTE: Study terminated early, no results are available for this endpoint"|24 months|||||||
1238612|NCT00594230|Secondary|Duration of Response|"Duration of response is defined as the time from when objective response is realized until time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Objective Response = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study|||||||
1238613|NCT00594230|Secondary|Hematologic Improvement, Including Transfusion Independence|"Hematologic measures will include total WBC and platelets~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study|||||||
1238614|NCT00594230|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study, every 3 months in follow-up until progression of disease|||||||
1238615|NCT00594230|Primary|Overall Response Rate (CR, Marrow CR + PR) of LBH in Patients With Relapsed or Refractory MDS.|Overall response rate (ORR) is defined by the modified International Working Group (IWG) Response Criteria for MDS. In the marrow, Complete Response (CR) is <= 5% blasts present with normal maturation of all cell lines. In peripheral blood, CR is defined as hemoglobin >= 11 g/dL, ANC >= 1000/mL, and platelets >= 100,000 with 0% blasts present. Partial Response (PR) is defined the same as CR with blasts decreased by >= 50% and >= 5% blasts in the marrow.|Every 8 weeks up to 24 months on-study.|All evaluable patients assessed for response prior to early study termination - one patient in each arm was not evaluable due to coming off-study prior to assessment|||participants|||Number
1238845|NCT00593450|Secondary|Area of Lesion||at 1 Year||||mm^2||Standard Deviation|Mean
1238616|NCT00594204|Primary|Number of Participants With 4-week Continuous Abstinence|The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits|Weeks 9 through 12|Intent-to-treat (ITT)|||participants|||Number
1238617|NCT00594204|Secondary|Number of Participants With Seven-day Point Prevalence of Abstinence|Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day|Week 12 and 24|ITT|||participants|||Number
1238618|NCT00594204|Secondary|Number of Participants With Continuous Abstinence|The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm|Weeks 9 through 24|ITT|||participants|||Number
1238619|NCT00594178|Secondary|Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan|Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle.|baseline and 3 months Post-exercise||||grams/cm^2||Standard Deviation|Mean
1238620|NCT00594178|Primary|Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data|Lean muscle mass was measured with Dual-Energy X-ray Absortiometry (DEXA) scan, which uses low dose radiation to assess bone density and soft tissue density. pre and post, three month exercise protocol on a passivie motorized exercise bicycle.|baseline and 3 months|analysis per protocol|||grams||Standard Deviation|Mean
1238621|NCT00594165|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person’s level of daytime sleepiness.|Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set. Last observation carried forward (LOCF) was utilized.|||Score on a scale||Standard Deviation|Mean
1238622|NCT00594165|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|7 years|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.|||subjects|||Number
1238623|NCT00594165|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|7 years|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.|||Subjects|||Number
1238624|NCT00594100|Secondary|Patency at 30 Days|Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.|Treatment through 30-day visit window|Subjects with successful stent placement and ultrasound evaluation at 30-day follow-up evaluation.|||participants|||Number
1238625|NCT00594100|Secondary|Clinical Success|Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC).|24-48 Hours Post-Procedure|All enrolled subjects with post procedure angiographic assessment of lesion stenosis|||participants|||Number
1238626|NCT00594100|Secondary|Stent Success|Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of < 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory.|Procedure|All enrolled subjects with post procedure angiographic assessment of lesion stenosis|||participants|||Number
1238627|NCT00594100|Secondary|Flow Reversal System Success|Number of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure.|Procedure||||participants|||Number
1238628|NCT00594100|Secondary|Flow Reversal System Technical Success|Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)|Procedure|All enrolled subjects|||participants|||Number
1238629|NCT00594100|Primary|Composite Major Adverse Event (MAE) Rate|Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)|Treatment through 30-day visit window|All primary endpoint evaluable subjects|||participants|||Number
1238630|NCT00594061|Secondary|Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral|PB-K Test was constructed to be an open-set test of word understanding for children. It is scored as a percentage of words correct. The test was measured using the Iowa/Nucleus 10/10 mm and Nucleus Freedom together, the Iowa/Nucleus 10/10 mm only, and the Nucleus Freedom electrode only conditions. The higher the score, the better the word understanding. The post-operative time point for this score was reported on average at 56 months post-implantation.|56 months||||percentage of words correct||Standard Error|Mean
1238631|NCT00594061|Primary|Pre-school Language Test|Assesses global language skills using toys and pictures. This test assess auditory comprehension and expressive communication and a total language score is calculated. The reported score was assessed at 48 months post-implantation. The total language standard score ranges from 50-150. A higher total score indicates better performance. A raw score for total language is calculated and converted into a standard score.|48 months||||units on a scale||Standard Deviation|Mean
1238633|NCT00594022|Secondary|Scored Sleep Onset Latency (SOL on PSG)||Treatment Night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.|||minutes||Standard Deviation|Mean
1238634|NCT00594022|Secondary|Total Sleep Time (TST) in the First Hour After Lights Out||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.|||minutes||Standard Deviation|Mean
1238635|NCT00594022|Secondary|Total Sleep Time (TST) in the First 2 Hours After Lights Out||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.|||minutes||Standard Deviation|Mean
1238636|NCT00594022|Secondary|Subjective Sleep Onset Latency (SOL)||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.|||minutes||Standard Deviation|Mean
1238637|NCT00594022|Primary|Latency to Persistent Sleep (LPS)||Treatment Night|Only 282 of the Polysomnography results were scorable. 132 for the treatment (stim group) and 150 for the sham group.|||minutes||Standard Deviation|Mean
1238638|NCT00593957|Secondary|Mean SSI Score for Total Subjects at Baseline and 6 Months|Analysis of Difference in Mean Screen for Social Interaction (SSI) Score between 0-6 months for total sample (n=19).|0-6 months|19 subjects (total sample) for whom complete data was available|||scores on a scale||Standard Deviation|Mean
1238639|NCT00593957|Secondary|Difference in SSI Mean Score at Six Months Compared to Baseline for Each Treatment Arm.|The Screen for Social Interaction (SSI) is a 54-item parent/caregiver-report screening instrument that emphasizes reciprocal social interaction including joint attention skills. The items are positive (prosocial) and are scored on a four-point frequency scale (child displays the behavior “almost never” = 0 to “almost all the time” = 3). Thus lower scores reflect a slower or delayed development, and higher scores reflect more normative development. SSI total scores range from 0-162. There are no subscales. Difference in Screen for Social Interaction (SSI) mean scores between baseline and 6 months post-treatment for each treatment arm are reported.|Initial and 6 month followup|Those who provided complete information only were included. Others did not provide adequate or complete information for analysis.|||scores on a scale||Standard Deviation|Mean
1238640|NCT00593957|Secondary|Improvement in Receptive Language as Measured by the Mullen Scale.|The Mullen Receptive language scale pre and 6 months post DM, measured as a change in the mean score of language, by age in months.|Change in mean between Initial and 6-month follow-up|25/35 enrolled participants completed the receptive language scale of the Mullen and underwent the analysis.|||age in months||Standard Deviation|Mean
1238641|NCT00593957|Primary|Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm.|Difference in EEG spike count means pre and 6 months post-treatment in each of three treatment groups.|Initial and 6-month post-treatment|33/35 participants who completed the protocol with two epochs of 5 mins of non-Rapid eye movement (REM)sleep during which spikes could be counted pre and post DM intake.|||EEG spike counts per minute||Standard Deviation|Mean
1238642|NCT00593918|Primary|Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression|IL-2 measured from nasal lavage samples by Luminex multiplex assay|1-5 days during acute illness (not after day 5 of illness)||||Percentage of Participants|||Number
1238643|NCT00593918|Primary|Nasal Interferon (IFN)-a2|Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.|1-5 days during acute illness (not after day 5 of illness)|Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.|||pg/ml||Standard Deviation|Mean
1238644|NCT00593866|Secondary|The Percentage of Participants Free From Local Progression at 2 Years||2 Years||||percentage of participants||95% Confidence Interval|Number
1238645|NCT00593866|Primary|The Maximum Tolerated Radiation Dose|The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.|13 weeks post radiation||||Gray (Gy)|||Number
1238646|NCT00593840|Post-Hoc|Kaplan Meier Estimate of Progression-free Survival|-Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years||||percentage of participants-Kaplan Meier|||Number
1238647|NCT00593840|Post-Hoc|Kaplan Meier Estimate of Regional Recurrence Free Survival|-Recurrence is defined as the return of cancer after treatment|3 years||||percentage of participants-Kaplan Meier|||Number
1238648|NCT00593840|Secondary|Patterns of Failure Associated With Implementation of Primary Objective|For patients who demonstrate a local failure during follow-up, a computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imagine (MRI) scan is fused with the original treatment planning CT scan using the computational environment for radiation research (CERR) developed at Washington University Medical Center. The methodology to transfer the digital imaging study via network to the radiation therapy research servers is mature. The original dose distribution and contours are correlated with the recurrent disease noted on the follow up imaging study. The recurrence is then classified as infield, marginal to the treatment field, or out of the treatment field depending on the dose received by the recurrent disease. Failures that occur in the treatment field are due to aspects of tumor biology rather than errors in the volume irradiated. As has been the case in our historical controls, the investigators expect most failures to be in the treatment field.|5 years from completion of treatment||2020-04-30|04/2020||||
1238649|NCT00593840|Secondary|Kaplan Meier Estimate of Overall Survival||3 years||||percentage of participants-Kaplan Meier|||Number
1238650|NCT00593840|Secondary|Disease Specific Survival Rate||5 years from completion of treatment||2020-04-30|04/2020||||
1238846|NCT00593450|Secondary|Dye Leakage on Angiogram||at 1 Year||||Participants|||Number
1238652|NCT00593840|Secondary|Quality of Life (QOL) as Measured by Xerostomia QOL Data|-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.|Median follow-up was 22 months||||units on a scale||Standard Deviation|Mean
1238653|NCT00593840|Secondary|Quality of Life (QOL) as Measured by Overall Global QOL Scores|-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.|Median follow-up was 22 months|65 out of 73 patients had evaluable QOL data in Arm 1.|||units on a scale||Standard Deviation|Mean
1238654|NCT00593840|Secondary|Kaplan Meier Estimate of Locoregional Recurrence Free Survival|"Recurrence is defined as the return of cancer after treatment~Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame"|3 years||||percentage of participants-Kaplan Meier|||Number
1238655|NCT00593840|Primary|Number of Participants With a Recurrence in the Unirradiated Neck(s)|"Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.~Recurrence is defined as the return of cancer after treatment~Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease."|12 months of follow-up||||participants||95% Confidence Interval|Number
1238656|NCT00593827|Secondary|Incidence of All Grades of Peripheral Neuropathy|All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.|Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).|Safety population.|||Participants|||Number
1238657|NCT00593827|Other Pre-specified|Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).|"ITT population: Participants randomized on the study (eligible and ineligible). AEs, AEs leading to death and GR 3-4 AEs: Safety population-Participants who received atleast 1 dose of study drug).~AEs leading to death: For 4 participants in Arm 1 and both participants in Arm 2, the reported AE term was disease progression."|||Participants|||Number
1238658|NCT00593827|Secondary|Duration of Response|Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.|From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)|ITT population with CR or PR.|||Months||95% Confidence Interval|Median
1238659|NCT00593827|Secondary|Time to Response|"Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.~CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD."|From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)|ITT population with CR or PR.|||Months||Full Range|Median
1238660|NCT00593827|Secondary|Overall Survival (OS)|"Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.~Survival time (months) = (End date – date of randomization + 1)/30.4375"|From the date of randomization to date of death (maximum participant OS of 26.3 months)|ITT population: Participants who were randomized on the study (eligible and ineligible).|||Months||95% Confidence Interval|Median
1238661|NCT00593827|Secondary|Best Response as Assessed With RECIST|Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.|Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)|Evaluable population: All treated participants with CR, PR, SD, PD, or NE response and who had received at least 1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1238676|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test|The number of correct digit-for-number substitutions on a Digit Symbol Substitution Test in the 90-second period was recorded to assess psychomotor and cognitive function. The score was the average of 2 mornings' tests. Worst Value: 0. Best Value: No Limit.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1238662|NCT00593827|Secondary|Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]|"ORR is defined as the proportion of responders (complete response [CR] + partial response [PR] in participants with measurable disease) in that arm among all randomized participants.~CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.~Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], X-ray) or as ≥10 mm with spiral CT scan."|Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)|Evaluable population-All treated participants with CR, PR, stable disease (SD), progressive disease (PD), or nonevaluable (NE) response and who had received at least 1 dose of study drug. Please refer outcome measure 4 for explanation of SD, PD, and NE.|||Percentage of Participants||95% Confidence Interval|Number
1238663|NCT00593827|Secondary|Median Progression Free Survival|PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date – date of randomization + 1)/30.4375.|From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)|ITT population: Participants who were randomized on the study (eligible and ineligible).|||Months||95% Confidence Interval|Median
1238664|NCT00593827|Primary|Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months|PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.|From the date of randomization to 6-months on study|ITT population: Participants who were randomized on the study (eligible and ineligible).|||Percentage of Participants||95% Confidence Interval|Number
1238665|NCT00593814|Secondary|Number of Subjects With Device Efficacy Events||2 years||||Participants|||Count of Participants
1238666|NCT00593814|Primary|Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure||2 years||||participants|||Number
1238667|NCT00593736|Secondary|Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period.|Average Cmax calculated as the average of three highest Cmax observations within the sampling period.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||μg/dL||Standard Error|Least Squares Mean
1238668|NCT00593736|Secondary|The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours|Area under the concentration-time curve is a measure of total drug exposure.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||μg/dL/hour||Standard Error|Least Squares Mean
1238669|NCT00593736|Secondary|The Total Duration of Secretion of Melatonin|The total duration of time from Dim Light Melatonin Secretion Onset to Dim Light Melatonin Secretion Offset.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||minutes||Standard Error|Least Squares Mean
1238670|NCT00593736|Secondary|The Time of Dim Light Melatonin Secretion Offset|Dim Light Melatonin Secretion Offset is defined as the first time of the morning (on a 24-hour clock) when the melatonin drops to below 3 pg/mL with a negative slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238671|NCT00593736|Secondary|The Time of Dim Light Melatonin Secretion Onset|Linear Dim Light Melatonin Secretion Onset is defined as the first time of the evening (on a 24-hour clock) when the melatonin level rises above 3.0 pg/ml with a positive slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238672|NCT00593736|Secondary|Visual Analogue Scale for Feelings|Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value:0 mm.. Best Value:100 mm.. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
1238673|NCT00593736|Secondary|Visual Analogue Scale for Mood|Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value: 0 mm. Best Value: 100 mm. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
1238674|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed|After 16 words were read to a subject, a subject waited 1 minute and then was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings’ tests was calculated.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||score||Standard Error|Least Squares Mean
1238675|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate|After 16 words were read to a subject, a subject was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings’ tests was calculated.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||score||Standard Error|Least Squares Mean
1238677|NCT00593736|Secondary|Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your level of alertness this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1238678|NCT00593736|Secondary|Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your level of alertness this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1238679|NCT00593736|Secondary|Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your ability to concentrate this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1238680|NCT00593736|Secondary|Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your ability to concentrate this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1238681|NCT00593736|Secondary|Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)|The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, “How easy was it for you to wake or get up in the morning when on a school or working night?” was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1238682|NCT00593736|Secondary|Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)|The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, “How easy was it for you to wake or get up in the morning when on a school or working night?” was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1238683|NCT00593736|Secondary|Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “What time did you try to go to sleep last night?” Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238684|NCT00593736|Secondary|Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “What time did you try to go to sleep last night?” Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238685|NCT00593736|Secondary|Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe the quality of your sleep last night?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1238686|NCT00593736|Secondary|Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe the quality of your sleep last night?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1238687|NCT00593736|Secondary|Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, how many times do you think you woke up?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||number of awakenings||Standard Error|Least Squares Mean
1238688|NCT00593736|Secondary|Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, how many times do you think you woke up?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||number of awakenings||Standard Error|Least Squares Mean
1238689|NCT00593736|Secondary|Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, what is the total time you think you were awake?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238690|NCT00593736|Secondary|Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, what is the total time you think you were awake?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238691|NCT00593736|Secondary|Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long (total hours and minutes) do you think you slept last night?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238692|NCT00593736|Secondary|Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long (total hours and minutes) do you think you slept last night?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238693|NCT00593736|Secondary|Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long do you think it took you to fall asleep last night?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238694|NCT00593736|Secondary|Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long do you think it took you to fall asleep last night?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238695|NCT00593736|Secondary|Wake Time Measured by Actigraphy (Nights 13-14)|Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238696|NCT00593736|Secondary|Wake Time Measured by Actigraphy (Nights 6-7)|Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238697|NCT00593736|Secondary|Sleep Time Measured by Actigraphy (Nights 13-14)|Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238698|NCT00593736|Secondary|Sleep Time Measured by Actigraphy (Nights 6-7)|Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238699|NCT00593736|Secondary|Sleep Latency Measured by Actigraphy (Nights 13-14)|The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238700|NCT00593736|Secondary|Sleep Latency Measured by Actigraphy (Nights 6-7)|The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238701|NCT00593736|Secondary|Wake Bouts Measured by Actigraphy (Nights 13-14)|The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||wake bouts||Standard Error|Least Squares Mean
1238702|NCT00593736|Secondary|Wake Bouts Measured by Actigraphy (Nights 6-7)|The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||wake bouts||Standard Error|Least Squares Mean
1238717|NCT00593736|Secondary|Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The number of wake minutes after the onset of persistent sleep prior to the end of recording.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238703|NCT00593736|Secondary|Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14)|Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238704|NCT00593736|Secondary|Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7)|Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238705|NCT00593736|Secondary|Sleep Efficiency Measured by Actigraphy (Nights 13-14)|Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
1238706|NCT00593736|Secondary|Sleep Efficiency Measured by Actigraphy (Nights 6-7)|Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
1238707|NCT00593736|Secondary|Total Sleep Time Measured by Actigraphy (Nights 13-14)|Total sleep time pertains to the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238708|NCT00593736|Secondary|Total Sleep Time Measured by Actigraphy (Nights 6-7)|Total sleep time calculated using the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238709|NCT00593736|Secondary|Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238710|NCT00593736|Secondary|Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238711|NCT00593736|Secondary|Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238712|NCT00593736|Secondary|Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
1238713|NCT00593736|Secondary|Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238714|NCT00593736|Secondary|Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238715|NCT00593736|Secondary|Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||number of awakenings||Standard Error|Least Squares Mean
1238716|NCT00593736|Secondary|Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||number of awakenings||Standard Error|Least Squares Mean
1238847|NCT00593450|Secondary|Fluid on Optical Coherence Tomography||at 1 Year||||Participants|||Number
1238718|NCT00593736|Secondary|Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The number of wake minutes after the onset of persistent sleep prior to the end of recording.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238719|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
1238720|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
1238721|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
1238722|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
1238723|NCT00593736|Secondary|Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238724|NCT00593736|Secondary|Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238725|NCT00593736|Secondary|Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238726|NCT00593736|Primary|Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).|Nights 6-7|Analysis was conducted on the full analysis set (FAS), which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
1238727|NCT00593684|Secondary|Infection Rate|Infection was defined as recovery of a bacterial pathogen or fungus from any single blood culture. Infection rate was defined as Infections/1000 line days.|infection per 1,000 Line Days||||Infection per 1,000 line days|||Number
1238728|NCT00593684|Primary|Serum Silver Concentrate at 28 Days|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine results at 28 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|28 Days from enrollment|two subjects died in the treatment group; one subject died in the control group|||ng ml -1||Standard Deviation|Mean
1238729|NCT00593684|Primary|Serum Silver Concentration at 7 Days|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine the results at 7 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|7 Days from enrollment|One subject in each group died|||ng ml -1||Standard Deviation|Mean
1238730|NCT00593684|Primary|Serum Silver Concentration at 1 Day|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we are examining the results of first day, or 24 hours from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|1 Day (first 24 hours from enrollment)|Study design included intent-to-treat for data collection and intention to stop if signs of toxicities or adverse effects were noted.|||ng ml -1||Standard Deviation|Mean
1238731|NCT00593645|Secondary|Median Time to Progression|Time to progression is defined as the length of time from the start of treatment until the disease starts to get worse or spread to other parts of the body.|5 years from time of restaging|Of the four surviving patients, three relapsed. One patient remained in remission on day +120.|||days||Full Range|Median
1238732|NCT00593645|Secondary|Use Conventional STR-PCR Method for Monitoring Engraftment|Includes assessment of mixed chimerism in the whole blood, myeloid cells, T cells, and B cells.|Up to 1 year after transplant|This outcome was not analyzed specifically as the conventional STR-PCR method was used for monitoring engraftment.||||||
1238733|NCT00593645|Secondary|Rate of Chronic Graft-versus-host Disease (GVHD)||100 days-1 year after transplant|None of the participants had chronic graft-versus-host disease (GVHD). 3 participants expired prior to day 100.|||percentage of participants|||Number
1238734|NCT00593645|Secondary|Rate of Acute Graft-versus-host Disease (GVHD)|Acute GVHD occurs within 100 days of transplant.|Up to 100 days after transplant||||percentage of participants|||Number
1238735|NCT00593645|Secondary|Disease-free Survival|Disease-free survival is defined as the length of time after treatment ends that the participant survives without any signs or symptoms of that cancer.|5 years from time of restaging|None of the patients analyzed survived without any signs or symptoms of that cancer.|||participants|||Number
1238736|NCT00593645|Secondary|Overall Survival||5 years from time of restaging||||days||Full Range|Median
1238737|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +80-+90|3 participants were not analyzed as they were deceased.|||participants|||Number
1238738|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +40-+60|3 participants were not analyzed because they were expired.|||participants|||Number
1238739|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +30|2 participants were not analyzed because they expired prior to Day +30.|||participants|||Number
1238740|NCT00593645|Secondary|Disease Specific Response Rates|Disease-specific partial response and complete response.|One, three, six and twelve months.|"This outcome was not analyzed due to terminating the study after 7 participants were enrolled.~We felt that the engraftment as measured by percent donor chimerism provided better response details than the limited data that was collected for the disease specific partial and complete response rates."||||||
1238741|NCT00593645|Primary|Six-month Treatment Related Mortality||6 months|"This outcome was not analyzed.~Enrollment to the trial was halted after three of the first seven patients expired. This fulfilled the predefined stopping rule as it was unlikely that we would achieve our primary end point of a 6 month treatment-related mortality of 10%."||||||
1238742|NCT00593606|Secondary|Patient Treatment Preference Scale Question 7|What aspects do you like the least about the patch? Check all that apply.|28 days|Full Analysis Set|||participants|||Number
1238743|NCT00593606|Secondary|Patient Treatment Preference Scale Question 6|What aspects do you like the most about the patch?|28 days|Full Analysis Set|||participants|||Number
1238744|NCT00593606|Secondary|Patient Treatment Preference Scale Question 5|I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson’s disease.|28 days|Full Analysis Set|||participants|||Number
1238745|NCT00593606|Secondary|Patient Treatment Preference Scale Question 4|I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson’s disease.|28 days|Full Analysis Set|||participants|||Number
1238746|NCT00593606|Secondary|Patient Treatment Preference Scale Question 3|In comparing the patch and previous oral treatments for Parkinson’s disease, how satisfied have you been with oral medication / patch?|28 days|Full Analysis Set|||participants|||Number
1238747|NCT00593606|Secondary|Patient Treatment Preference Scale Question 2|Why did you decide to enter this study?|28 days|Full Analysis Set|||participants|||Number
1238748|NCT00593606|Secondary|Patient Treatment Preference Scale Question 1|Have you used pharmaceutical treatments for your Parkinson’s disease before the study?|28 days|Full Analysis Set|||participants|||Number
1238749|NCT00593606|Secondary|Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment|"The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease.~Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238750|NCT00593606|Secondary|Patient Global Impression (PGI) Item 3|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication)"|28 days|Full Analysis Set|||participants|||Number
1238751|NCT00593606|Secondary|Patient Global Impression (PGI) Item 2|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked – Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse)"|28 days|Full Analysis Set|||participants|||Number
1238752|NCT00593606|Secondary|Patient Global Impression (PGI) Item 1 Score|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse)"|28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238753|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 3.2|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect)"|28 days|Full Analysis Set|||participants|||Number
1238754|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 3.1|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked – Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse)"|28 days|Full Analysis Set|||participants|||Number
1238755|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 2 Score|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse)"|28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238756|NCT00593606|Secondary|Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 1 measures 'Severity of Parkinson’s Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set|||score on scale||Standard Deviation|Mean
1238782|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Renal/Genitourological’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238757|NCT00593606|Secondary|Change in Parkinson’s Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment|The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson’s disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238758|NCT00593606|Secondary|Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment|The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238759|NCT00593606|Secondary|Change in Parkinson’s Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment|"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson’s disease.~Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238760|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238761|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238762|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238763|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
1238764|NCT00593606|Primary|Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period||Baseline, 56 days|Safety Set|||participants|||Number
1238765|NCT00593606|Primary|Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)||Baseline, 2 days|Safety Set|||participants|||Number
1238766|NCT00593606|Primary|Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period||Baseline, 56 days|Safety Set|||participants|||Number
1238767|NCT00593606|Primary|Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)||Baseline, 2 days|Safety Set|||participants|||Number
1238768|NCT00593606|Primary|Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment||Baseline, 28 days|Safety Set|||participants|||Number
1238769|NCT00593606|Primary|Completion of Trial From Baseline to End of Treatment||Baseline, 28 days|Safety Set|||participants|||Number
1238770|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Other’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238771|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Sensory Perception’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238772|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Involuntary Movements’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238773|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Coordination/Balance’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238774|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Gait’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238775|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Plantar Reflex’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238776|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Cranial Nerve Function’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238777|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Muscle Strength’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238778|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Deep Tendon Reflexes’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238779|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Mental Status’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238780|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Other’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238781|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Metabolic/Endocrine’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238789|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Hematological/Lymphatic Nodes’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238790|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Psychiatric’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238791|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Ears, Eyes, Nose, Mouth, Throat’||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
1238792|NCT00593606|Primary|Change in Uric Acid|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||µmol/l||Standard Deviation|Mean
1238793|NCT00593606|Primary|Change in Total Protein|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||g/dl||Standard Deviation|Mean
1238794|NCT00593606|Primary|Change in Total Bilirubin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
1238795|NCT00593606|Primary|Change in Sodium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmol/l||Standard Deviation|Mean
1238796|NCT00593606|Primary|Change in Glutamic Pyruvic Transaminase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Units/l||Standard Deviation|Mean
1238797|NCT00593606|Primary|Change in Serum Glutamic Oxaloacetic Transaminase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Units/l||Standard Deviation|Mean
1238798|NCT00593606|Primary|Change in Potassium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmol/l||Standard Deviation|Mean
1238799|NCT00593606|Primary|Change in Inorganic Phosphate|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
1238800|NCT00593606|Primary|Change in Glucose|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
1238801|NCT00593606|Primary|Change in Gamma-Glutamyltransferase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Units/l||Standard Deviation|Mean
1238802|NCT00593606|Primary|Change in Creatinine|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
1238803|NCT00593606|Primary|Change in Chloride|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmol/l||Standard Deviation|Mean
1238804|NCT00593606|Primary|Change in Calcium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
1238805|NCT00593606|Primary|Change in Blood Urea Nitrogen|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmol/l||Standard Deviation|Mean
1238806|NCT00593606|Primary|Change in Alkaline Phosphatase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Units/l||Standard Deviation|Mean
1238807|NCT00593606|Primary|Change in Albumin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||g/l||Standard Deviation|Mean
1238808|NCT00593606|Primary|Change in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Giga/l||Standard Deviation|Mean
1238809|NCT00593606|Primary|Change in Red Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Tera/l||Standard Deviation|Mean
1238810|NCT00593606|Primary|Change in Platelet Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Giga/l||Standard Deviation|Mean
1238811|NCT00593606|Primary|Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
1238812|NCT00593606|Primary|Change in Percentage of Monocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
1238813|NCT00593606|Primary|Change in Percentage of Lymphocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
1238814|NCT00593606|Primary|Change in Hemoglobin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||g/l||Standard Deviation|Mean
1238815|NCT00593606|Primary|Change in Hematocrit|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||l/l*100||Standard Deviation|Mean
1238816|NCT00593606|Primary|Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
1238817|NCT00593606|Primary|Change in Percentage of Basophilic Granulocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
1238818|NCT00593606|Primary|Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||msec||Standard Deviation|Mean
1238819|NCT00593606|Primary|Change in QT Interval|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||msec||Standard Deviation|Mean
1238820|NCT00593606|Primary|Change in QRS Duration|"The QRS duration represents the time it takes for ventricular depolarization to occur.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||msec||Standard Deviation|Mean
1238821|NCT00593606|Primary|Change in PR Interval|"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex).~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||msec||Standard Deviation|Mean
1238822|NCT00593606|Primary|Change in Heart Rate|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
1238823|NCT00593606|Primary|Change in Diastolic Blood Pressure (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
1238824|NCT00593606|Primary|Change in Systolic Blood Pressure (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
1238825|NCT00593606|Primary|Change in Pulse Rate (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
1238826|NCT00593606|Primary|Change in Diastolic Blood Pressure (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
1238827|NCT00593606|Primary|Change in Systolic Blood Pressure (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
1238828|NCT00593606|Primary|Change in Pulse Rate (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
1238829|NCT00593606|Primary|Change in Diastolic Blood Pressure (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
1238830|NCT00593606|Primary|Change in Systolic Blood Pressure (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 Days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
1238831|NCT00593606|Primary|Change in Pulse Rate (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
1238832|NCT00593606|Primary|Change in Diastolic Blood Pressure (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
1238833|NCT00593606|Primary|Change in Systolic Blood Pressure (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
1238834|NCT00593606|Primary|Change in Pulse Rate (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
1238835|NCT00593554|Secondary|Frequency of Infection|Number of unique patients with bacterial and/or viral infections reported.|Day 0 through 1 year post transplantation|Patients who received a transplant|||Participants|||Count of Participants
1238836|NCT00593554|Secondary|Chronic Graft vs. Host Disease (GvHD)|Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.|Up to 1 year|Patients who received a transplant|||Participants|||Count of Participants
1238837|NCT00593554|Secondary|Acute Graft vs. Host Disease (GvHD)|Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.|Up to 1 year|Patients who received a transplant|||Participants|||Count of Participants
1238838|NCT00593554|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|Patients who received a transplant and who achieved platelet recovery/engraftment of platelets|||days||95% Confidence Interval|Median
1238839|NCT00593554|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|Patients who received a transplant|||days||95% Confidence Interval|Median
1238840|NCT00593554|Secondary|Regimen-related Toxicity|The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.|Up to 1 year|Patients who received a transplant|||Participants|||Count of Participants
1238841|NCT00593554|Primary|Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation|To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.|thru 6 months after transplant|Patients who received a transplant|||percentage of patients||95% Confidence Interval|Number
1238842|NCT00593450|Secondary|Change in Diastolic Blood Pressure From Baseline||Baseline and 1 Year||||mm Hg||Standard Deviation|Mean
1238843|NCT00593450|Secondary|Change in Systolic Blood Pressure From Baseline||Baseline and 1 Year||||mm Hg||Standard Deviation|Mean
1238854|NCT00593450|Secondary|Visual-acuity Score and Snellen Equivalent (Continuous)|"Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.~In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity."|at 1 Year||||No. of Letters||Standard Deviation|Mean
1238855|NCT00593450|Secondary|Visual-acuity Score and Snellen Equivalent (Frequency)||at 1 Year||||Participants|||Number
1238856|NCT00593450|Primary|Change From Baseline in Visual-acuity Score (Continuous)|"Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline.~In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement."|Baseline and 1 Year|All patients who had VA measured at week 52 were included in the analysis. All analyses were performed on the basis of the intention-to-treat principle. The Data and Safety Monitoring Committee recommended that data for all 23 patients at one center be excluded because of serious protocol noncompliance.|||No. of Letters||Standard Deviation|Mean
1238857|NCT00593450|Secondary|Change From Baseline Visual-acuity Score (Frequency)||Baseline and 1 Year||||Participants|||Number
1238858|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|36 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238859|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|24 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238860|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|12 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238861|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|9 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238862|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|6 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238863|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|1 Month|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238864|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|36 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238865|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|24 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238866|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|12 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238867|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|9 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238868|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|6 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238869|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|1 Month|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238870|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|36 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238871|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|24 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238872|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|12 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238873|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|9 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238874|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|6 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238875|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|1 Month|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238876|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|36 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238877|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|24 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238878|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|12 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238879|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|9 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238880|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|6 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238881|NCT00593385|Secondary|Early Clinical Success|Improvement of the Rutherford-Becker clinical criteria by ≥ 1 category. (Classification system for evaluating clinical improvement as defined by Rutherford R, Becker G. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. Journal of Vascular Interventional Radiology 1991;2:169-174.)|1 Month|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238882|NCT00593385|Secondary|Major Adverse Vascular Event (MAVE)|Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.|360 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238883|NCT00593385|Secondary|Major Adverse Vascular Event (MAVE)|Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.|270 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238884|NCT00593385|Secondary|Major Adverse Vascular Event (MAVE)|Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.|180 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238885|NCT00593385|Secondary|Major Adverse Vascular Event (MAVE)|Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.|30 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238886|NCT00593385|Secondary|Major Adverse Event (MAE)|Composite rate of MAVE or any death, or stroke.|30 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1238887|NCT00593385|Secondary|Device Success|Successful delivery and deployment of the study stent and intact retrieval of the delivery system.|Post-procedure|ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.|||Participants|||Count of Participants
1238888|NCT00593385|Secondary|Acute Procedural Success|Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE.|Post-procedure|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
1239037|NCT00591591|Primary|Percentage of Oxygen Saturation in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.|||Percentage of brain oxygen saturation||Standard Deviation|Mean
1238889|NCT00593385|Primary|Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis|The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months.|Within 9 Months post-procedure|ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.|||Percentage of subjects|||Number
1238890|NCT00593372|Secondary|Change on Mini-Mental State Examination||End of Study|||||||
1238891|NCT00593372|Primary|Number of Successful Memory Tasks Completed Over Study Period.|"Successful memory tasks are those memory tasks (such as where do I keep my keys) that participants are able to consistently respond to."|8 weeks||||memory tasks|||Number
1238892|NCT00593346|Secondary|Frequency of Grade 3-4 Toxicities|RTOG acute and late toxicity grading system and via a visual analog scale for pain assessment.|Up to 1 year from completion of therapy||||participants|||Number
1238893|NCT00593346|Secondary|Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment||5 years after treatment completion||||participants|||Number
1238894|NCT00593346|Secondary|Presence or Absence of Complications|As defined by number of participants who experienced breast infection and symptomatic fat necrosis.|5 years after treatment completion||||participants|||Number
1238895|NCT00593346|Primary|Local Control Using Disease-free Survival Rates||5 years after treatment completion||||percentage of participants|||Number
1238896|NCT00593346|Primary|Local Control Using Disease-free Survival Rates||2 years after treatment completion||||percentage of participants|||Number
1238897|NCT00593346|Primary|Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates||5 years after treatment completion||||percentage of participants|||Number
1238898|NCT00593346|Secondary|Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)|-Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA)|Pre-treatment and 3 years|82 participants had cosmetic outcome data through 3 years of follow-up.|||percentage of breast retraction||95% Confidence Interval|Mean
1238899|NCT00593346|Secondary|Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported|"-Patients filled out a form Patient Evaluation of the Treated Breast. On this form the patients were asked to compare the memory of what their breast looked like after surgery but before radiation and to compare that memory to the appearance of the breast after radiation. The patients were then asked if their breast changes were due to:~caused mostly by radiation~caused by both the radiation and surgery, but mostly by the radiation~caused by both the radiation and surgery, but mostly by the surgery~caused mostly by the surgery~can't judge which treatment caused the change~there are no changes"|3 years|82 participants had cosmetic outcome data through 3 years of follow-up.|||percentage of participants|||Number
1238900|NCT00593346|Secondary|Excellent-good Cosmetic Outcomes - Physician Reported|"Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA).~The global cosmetic result were scored on a 4-point scale where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference)."|3 years after completion of therapy|82 participants had cosmetic outcome data through 3 years of follow-up.|||percentage of participants|||Number
1238901|NCT00593346|Secondary|Excellent-good Cosmetic Outcomes - Patient Reported|"Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis.~The global cosmetic result were scored on a 4-point scare where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference)."|3 years after completion of therapy|82 participants had cosmetic outcome data through 3 years of follow-up.|||percentage of participants|||Number
1238902|NCT00593346|Secondary|Quality of Life Completion|-QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC breast cancer module QLQ-BR23 questionnaires. QLQ-C30 is composed of 30 questions. QLQ-BR23 consists of 23 questions.|2 years||||percentage of participants|||Number
1238903|NCT00593346|Primary|Local Control Using Ipsilateral Breast Tumor Recurrence Rates||2 years after treatment completion||||percentage of participants|||Number
1238904|NCT00593333|Primary|Healed Femur Fracture|Time to clinically healed fracture as measured by weeks.|baseline to healed fracture (weeks)||||Weeks||Full Range|Mean
1238905|NCT00593320|Primary|Quality of Life as Measured by the FACT-CNS Questionnaire|"The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns.~Participants can choose 0 (Not At All) up to 4 (Very Much) for each question."|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.||||||
1238906|NCT00593320|Primary|Musculoskeletal Function as Measured by the Oswestry Disability Index|The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.||||||
1238907|NCT00593320|Secondary|Local Control Rate|Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.|6 months after end of treatment|The first patient progressed while on treatment and the second patient was removed from study due to non-compliance.||||||
1238908|NCT00593320|Primary|Pain Control Rate as Measured by the The Brief Pain Inventory|The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.||||||
1238909|NCT00593112|Primary|H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.|||MRS Ratio||Standard Deviation|Mean
1238910|NCT00593112|Primary|H MRS Scan Results - Glutamine (Gln)/Ino|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.|||MRS Ratios||Standard Deviation|Mean
1238911|NCT00593112|Primary|Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.|||MRS Ratio||Standard Deviation|Mean
1238912|NCT00592943|Primary|Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)|Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.|Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits||||μg/mL||Standard Deviation|Mean
1238913|NCT00592943|Primary|Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)|Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.|Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits||||μg/mL||Standard Deviation|Mean
1238914|NCT00592943|Primary|Armodafinil DAT Occupancy in Caudate|Subjects received each dose level (100 and 250 mg) of armodafinil, followed by PET scans, in an open-label protocol. Repeat PET scans, using [1 1 C]altropane, determined DAT occupancy at 1 hour and 2.5 hours postdose (compared with baseline).|DAT occupancy was measured using the PET scan at 1 hour and 2.5 hours after oral administration of 100mg or 250 mg Armodafinil||||μg/mL||Standard Deviation|Mean
1238915|NCT00592904|Secondary|Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT|Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.|Baseline and Week 48|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1238916|NCT00592904|Secondary|Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)|The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study].|Baseline and Week 48|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.|||Participants|||Number
1238917|NCT00592904|Primary|Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48|Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).|Baseline and Week 48|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1238918|NCT00592904|Primary|Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.|SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.|Baseline and Week 48|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1238919|NCT00592904|Primary|Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.|Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.|Baseline and Week 48|Intent-to-Treat (ITT) Population: All enrolled subjects (starting at Visit 1) who took at least 1 dose of study drug and had at least 1 efficacy assessment in this trial comprised the ITT Population. All efficacy analyses were performed on the ITT Population. One subject had a protocol violation after consenting and was withdrawn from treatment.|||Scores on a Scale||Standard Deviation|Mean
1238920|NCT00592852|Secondary|Young Mania Rating Scale (YMRS)|This scale measures mania symptoms in children and adolescents using 11 items rated from 0 (least severe) to 4 (most severe), although 4 items are rated from 0-8. The minimum (least severe) possible score is 0, and the maximum (most severe) possible score is 60.|weekly|2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.|||Units on a scale||Standard Deviation|Mean
1238921|NCT00592852|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired).|weekly|2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.|||Units on a scale||Standard Deviation|Mean
1238922|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).|Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|Baseline to End of Treatment (12 weeks)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||nmol/L||Standard Deviation|Median
1238923|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)|Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||ng*ml||Standard Deviation|Mean
1238924|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).|Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|From baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||nM BCE||Standard Deviation|Mean
1238925|NCT00592839|Secondary|Mean Change in Stanford Sleepiness Scale|Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest).|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||Score on Scale||Standard Error|Least Squares Mean
1238926|NCT00592839|Secondary|Mean Change in Individual Sleep Parameters on a Three-point Scale|Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality)|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||scores on a scale||Standard Error|Least Squares Mean
1238927|NCT00592839|Primary|Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes|Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the intent-to-treat (ITT) cohort, [all subjects who were exposed to investigational product therapy,provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit]. Not all study subjects completed all data elements in their study diaries."|||Awakenings||Standard Error|Least Squares Mean
1238928|NCT00592774|Secondary|Analysis of Allodynia (Present/Not Present) at Week 15/EOT– by Treatment Groups ITT Population (Modified BOCF)|Allodynia is defined as a painful reaction to a non-painful stimulus.|Week 15|ITT population (Modified BOCF)|||Participants|||Number
1238929|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)|The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-D consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).|Baseline and Week 15|ITT population (Modified BOCF)|||Scores on a scale||Standard Deviation|Mean
1238930|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)|The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-A consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).|Baseline and Week 15|ITT population (Modified BOCF)|||Scores on a scale||Standard Deviation|Mean
1238931|NCT00592774|Secondary|Clinician Global Impression of Change (CGIC) at Week 15/EOT|Changes were calculated using the modified BOCF method|Week 15|Subset of ITT population used, including subjects that completed CGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used CGIC scores from Early Termination visit.|||Participants|||Number
1238932|NCT00592774|Secondary|Patient Global Impression of Change (PGIC) at Week 15/EOT|Changes were calculated using the modified BOCF method|Week 15|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.|||Participants|||Number
1238933|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in Average Sleep Interference Scores|The average of the last 7 available sleep scores prior to the visit, based on the 11-point Likert-type numerical rating scale for sleep interference (where 0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]), and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)|||Scores on a scale||Standard Deviation|Mean
1238934|NCT00592774|Primary|Change From Baseline in Average Pain Scores by Week|Change from baseline in average pain scores by week based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group.|Week 1 through Week 16|ITT Population|||Scores on a scale||Standard Deviation|Mean
1238935|NCT00592774|Primary|Responder Rate: Subjects With at Least 50 Percent Reduction in Pain|A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)|||Percentage of Participants|||Number
1238936|NCT00592774|Primary|Responder Rate: Subjects With at Least 30 Percent Reduction in Pain|A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)|||Percentage of Participants|||Number
1238937|NCT00592774|Primary|Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)|Average pain scores are based on pain intensity (11‑point Likert‑type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|Intent‑to‑Treat (ITT) Population- group of subjects who were randomized, took study drug, and had at least 1 efficacy assessment at Baseline. The modified Baseline Observation Carried Forward (BOCF) method was used.|||Scores on a scale||Standard Deviation|Mean
1238938|NCT00592761|Primary|Change in Duration of Hyoid Maximum Anterior Excursion|Change in the duration of maximum anterior movement of the hyoid bone during swallowing.|Baseline and 6 weeks||||seconds||Standard Deviation|Mean
1238939|NCT00592761|Secondary|Change in Duration of Opening of Upper Esophageal Sphincter|Change in duration of pre- and post-treatment duration of UES opening.|Baseline and 6 weeks||||seconds||Standard Deviation|Mean
1238940|NCT00592761|Secondary|Change in Oral Intake Ability|Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.|Baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
1238941|NCT00592761|Primary|Change in Duration of Superior Hyolaryngeal Movement|Change in duration of superior elevation of hyoid bone.|baseline and six weeks|per protocol|||seconds||Standard Deviation|Mean
1238942|NCT00592683|Secondary|DSM-IV Mania Symptom Checklist|The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0.|weekly for first 6 weeks then biweekly|14 subjects came in for week 12 assessments - included in final analysis.|||units on a scale||Standard Deviation|Mean
1238943|NCT00592683|Primary|Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)|The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.|weekly for 1st 6 weeks then biweekly|14 subjects came in for week 12 assessments - included in final analysis.|||Units on a scale||Standard Deviation|Mean
1238944|NCT00592631|Primary|Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)|Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.|7 to 10 nights after cpap is started.||||log mg/ml||Standard Error|Mean
1238945|NCT00592488|Secondary|Serum Lactate|Latest serum lactate between 12 and 36 hours|12-36 hours||||mg/dL||Standard Deviation|Mean
1238946|NCT00592488|Secondary|Vasopressor Dose|Change in vasopressor dose between 6 and 24 hours.|6-24 hours||||mcg/kg/min||Standard Deviation|Mean
1238947|NCT00592488|Primary|Mean Arterial Blood Pressure|Mean Arterial blood pressure measured non-invasively at 18 hours|18 hours|All patients treated. Intention to treat.|||mm Hg||Standard Error|Mean
1238948|NCT00592475|Secondary|Change From Baseline in Serum Sodium Levels at 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 Hours and on Day 8 Post Dose|"Baseline serum sodium value is the last measurement prior to dosing.~Change from baseline is calculated as time point minus baseline."|Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose|"Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants included in the calculation for each timepoint is noted in the category title."|||mEq/L||Standard Deviation|Mean
1239079|NCT00591344|Secondary|Duration of First Agonist Burst|Time in (ms) for the duration of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1238949|NCT00592475|Primary|Change From Baseline in Heart Rate at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose|"Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.~The number of participants per arm is consistent for all categories of the data table."|||bpm||Standard Deviation|Mean
1238950|NCT00592475|Primary|Change From Baseline in Blood Pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose|"Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.~The number of participants per arm is consistent for all categories of the data table."|||mmHg||Standard Deviation|Mean
1238951|NCT00592475|Primary|Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|"Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants included in the calculation for each timepoint is noted in the category title."|||mmHg||Standard Deviation|Mean
1238952|NCT00592475|Primary|Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline. (Note: 2 patients were not included in the analysis due to protocol deviations.) The number of participants included in the calculation for each timepoint is noted in the category title.|||mL/min||Standard Deviation|Mean
1238953|NCT00592475|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|"Participants Analyzed represents Full Analysis Set (FAS): All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants per arm is consistent for all categories of the data table."|||mmHg||Standard Deviation|Mean
1238954|NCT00592384|Primary|Hamilton Depression Rating Scale-Maier Subscale|The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.|0 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1238955|NCT00592384|Secondary|Hamilton Rating Scale for Anxiety||Weeks 0, 12|||||||
1238956|NCT00592384|Secondary|Patient Global Impression||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
1238957|NCT00592384|Secondary|Clinical Global Impression||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
1238958|NCT00592384|Secondary|Sheehan Disability Scale||Weeks 0, 12|||||||
1238959|NCT00592384|Secondary|Satisfaction With Life||Weeks 0, 12|||||||
1238960|NCT00592384|Secondary|Craig Handicap and Reporting Technique||Weeks 0, 12|||||||
1238961|NCT00592384|Secondary|Side Effects Checklist||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
1238962|NCT00592384|Secondary|SF-12||Weeks 0, 12, 24|||||||
1238963|NCT00592384|Secondary|Structured Clinical Interview for DSM IV Depression Module||Weeks 0, 12, 24|||||||
1238964|NCT00592384|Secondary|Modified Ashworth Spasticity Scale||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
1238965|NCT00592384|Secondary|Modified Brief Pain Inventory||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
1238966|NCT00592384|Secondary|Symptom Checklist-20 Depression Subscale||Weeks 0, 1, 3, 6, 8, 10, 12, 24|||||||
1238967|NCT00592384|Primary|Hamilton Depression Rating Scale-17|The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.|0 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1238968|NCT00592358|Secondary|Change in Symptoms Measured by DSM-IV Mania Symptoms Checklist|A 13-item clinician-rated symptom checklist developed by Massachusetts General Hospital to measure symptoms of mania. Each item is given a rating for frequency (1=less than 4 days, 2=greater than or equal to 4 days, 3=daily) and intensity (1=mild, 2=moderate, 3=severe), which are combined to yield a composite severity score ranging from 0 (least severe) to 3 (most severe). The composite severity scores from all 13 items are summed to yield a total measure score, with a minimum score of 0 (least severe) and a maximum score of 39 (most severe).|Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)|All participants for whom the mania checklist was available at both baseline and endpoint (8-weeks) were included in analyses.|||units on a scale||Standard Deviation|Mean
1238969|NCT00592358|Primary|Change in Symptoms Measured by Young Mania Rating Scale (YMRS)|The YMRS is an 11-item instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Four items are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven itemsare graded on a 0 to 4 scale. The maximum possible total score is 60 (worse outcome, severe symptoms), and the minimum possible total score is 0 (no symptoms).|Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)|Participants exposed to study medication for a minimum of three weeks were included in analyses.|||units on a scale||Standard Deviation|Mean
1239051|NCT00591578|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1238970|NCT00592319|Primary|Number of Case With Papilloma Recurrence During a 12-month Follow up|Criteria for the recurrence: the site scoring >4, plus visible lesion found in >50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.|12-month follow up|The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.|||case|||Number
1238971|NCT00592319|Secondary|Time Course (Month) With Papilloma Recurrence During 12-month Follow up|The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.|12 months|12-month follow-up|||month||Full Range|Mean
1238972|NCT00592176|Secondary|Number of Patients Having Surgical Removal of Pterygium.|The number of patients having surgical removal of pterygium within 12 months.|12 months|All subjects enrolled were analzyed.|||Participants|||Number
1238973|NCT00592176|Primary|The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.|"Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression~Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression."|Baseline and 3 months|All subjects enrolled were analzyed.|||area in millimeters squared||Standard Deviation|Mean
1238974|NCT00592124|Secondary|Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol||Measured through Week 21||||Participants|||Count of Participants
1238975|NCT00592124|Secondary|Reported Sharing of Product|Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant.|Measured through Week 21|Participants who completed a product sharing assessment at the end of the 6-week product use period.|||Participants|||Count of Participants
1238976|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein gel was used after the encounters.|||minutes|Sexual Encounters|Inter-Quartile Range|Median
1238977|NCT00592124|Secondary|Gel Usage After Sex|These summaries represent counts and percentages of participants using gel after last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as gel use|||Sexual Encounters|Sexual Encounters||Count of Units
1238978|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein gel was used before the encounters.|||minutes|Sexual Encounters|Inter-Quartile Range|Median
1238979|NCT00592124|Secondary|Gel Usage Before Sex|These summaries represent counts and percentages of participants using gel before last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as gel use|||Sexual Encounters|Sexual Encounters||Count of Units
1238980|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein tablets were used after the encounters. Timing data was not provided for two sexual encounters.|||minutes|Sexual Encounters|Inter-Quartile Range|Median
1238981|NCT00592124|Secondary|Tablet Usage After Sex|These summaries represent counts and percentages of participants using tablet after last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as tablet use|||Sexual Encounters|Sexual Encounters||Count of Units
1238982|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein tablets were used before the encounters. Timing data was not provided for four sexual encounters.|||minutes|Sexual Encounters|Inter-Quartile Range|Median
1238983|NCT00592124|Secondary|Tablet Usage Before Sex|These summaries represent counts and percentages of participants using tablet before last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as tablet use|||Sexual encounters|Sexual encounters||Count of Units
1238984|NCT00592124|Secondary|Frequency of Male Condom Use||Measured through Week 21||||3-week periods|3-week periods||Count of Units
1238985|NCT00592124|Secondary|Frequency of Sexual Activity|This represents the rate during the past 3 weeks at which participants engaged in vaginal sex.|Measured through Week 21||||3-week periods|3-week periods||Count of Units
1238986|NCT00592124|Secondary|Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses||Measured through Week 21|This outcome is based on evaluable participants.|||Participants|||Count of Participants
1238987|NCT00592124|Secondary|Number of Days Product Missed|This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product.|Measured through Week 21|This outcome is based on evaluable participants.|||days|3-week periods|Standard Deviation|Mean
1238988|NCT00592124|Secondary|Frequency of Product Use|This number represents how often participant used study product during the preceding 3 weeks and is measured twice during each 6 week product period.|Measured through Week 21||||3-week periods|3-week periods||Count of Units
1238989|NCT00592124|Primary|Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)|PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.|Measured through Week 21|Serum TFV and Tissue TFV measures do not include participants from South Africa clinical sites.|||ng/mL, ng/mg, ng/mL||Inter-Quartile Range|Median
1238990|NCT00592124|Primary|"Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future"||Measured through Week 21||||Participants|||Count of Participants
1238991|NCT00592124|Primary|Self-reported Adherence to Each Regimen|Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.|Measured through Week 21|For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of expected doses if she were fully adherent.|||percentage of expected doses||Standard Deviation|Mean
1238992|NCT00592072|Primary|Telephone Search|This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||symbols/ 90 min||Standard Error|Least Squares Mean
1238993|NCT00592072|Primary|Map Search (1min)|The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
1238994|NCT00592072|Primary|Map Search (2min)|The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
1238995|NCT00592072|Primary|Digit Symbol Coding|The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
1238996|NCT00592072|Primary|Letter/Number Sequencing|The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
1238997|NCT00592072|Primary|Digit Span Backward|The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
1238998|NCT00592072|Primary|Verbal Memory Recognition|The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
1238999|NCT00592072|Primary|Delayed Verbal Memory|The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
1239000|NCT00592072|Primary|Immediate Verbal Memory|Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
1239001|NCT00592007|Secondary|Overall Survival||Patients will be followed until death|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.||||||
1239002|NCT00592007|Primary|Progression-free Survival||14 weeks after start of fulvestrant|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.||||||
1239003|NCT00591942|Primary|Incidence of Post-operative Pain (Yes/no)|Scores reported are subjects reporting any pain (yes/no)|Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations||||participants|crowns||Number
1239004|NCT00591864|Secondary|Specificity|The number of women with negative imaging test per number of women without cancer.|at least one year following imaging||||participants|||Number
1239005|NCT00591864|Secondary|Sensitivity on the Per Tumor Level|Number of tumors detected per number of tumors diagnosed on surgery or biopsy.|within 1 week of surgery or biopsy||||tumors|Participants||Number
1239006|NCT00591864|Primary|Sensitivity on the Per Patient Level|Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.|within 1 week of surgery or biopsy|In the 84 patients who completed the study 28 were diagnosed with breast cancer.|||participants|||Number
1239008|NCT00591825|Secondary|Cognitive Functioning Measured Using the Wisconsin Card Sorting Task|The Wisconsin Card Sorting Task measures executive functioning and cognitive flexibility. The task uses a deck of 64 cards that the participant must sort according to specified rules. The test is stopped when when six sequences of 10 correct responses have been achieved, or after the deck has been completed twice, which provides a cumulative total of 128 trials. We report the number of errors on the task, which has a range of 0 -128, with a higher score representing worse performance.|2 weeks|Two subjects did not complete the test because they had previous exposure to the test.|||units on a scale||Standard Deviation|Mean
1239009|NCT00591825|Secondary|Cognitive Functioning Measured Using the Iowa Gambling Test|"This test measures a person's emotional decision making. Participants are presented with virtual decks of cards on a computer. Participants are told that each card they draw will win them game money. However, sometimes cards result in losing game money. The task includes 100 trials and the total score represents the number of cards drawn from bad decks as compared to good or safe decks. Thus, the score ranges from -100 to +100, with higher sores representing better performance."|2 weeks||||units on a scale||Standard Deviation|Mean
1239010|NCT00591825|Secondary|Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT)|The RCFT assesses the a person’s ability to use cues to retrieve information. The test measures visuospatial construction and memory. A person is asked to draw a figure. The figure is broken down into 18 elements. The score is based on their presence, completeness, and correct placement. Each element is scored from 0-2. The Copy, Immediate, and Delay results are scored on a 36 point scale. The higher the score, the better the person performed on the test with a 0 being the minimum and 36 being the maximum score. The organization score is scored according to whether the participant drew five cohesive units of the figure together, for a range of 0-6 and a higher score indicating better organizational performance.|2 weeks||||units on a scale||Standard Deviation|Mean
1239011|NCT00591825|Secondary|Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests)|This scale measures the learning and memory of functioning adults. Logical Memory I and II and Faces I and II subtests were administered to participants. The tasks measure verbal and visual memory, respectively. Scoring is based on the number of story details or faces correctly recalled during immediate (Logical Memory I, Faces I) and 30 minute delayed (Logical Memory II, Faces II) conditions. Total score ranges from 0-75 on Logical Memory I, 0-50 on Logical Memory II, 0-48 on Faces I, and 0-48 on Faces II. For all subtests, higher scores indicate better memory performance.|2 Weeks||||units on a scale||Standard Deviation|Mean
1239012|NCT00591825|Primary|fMRI Brain Activations During Symptom Provocation|Regions of interest (ROIs) were specified based on previous research and included amygdala, insula, dorsal anterior cingulate cortex (ACC), dorsolateral PFC (dlPFC), and hippocampus. Multiple regression analyses were used to examine differences in response between experimental conditions (spider versus butterfly images). For significant clusters of activation within ROIs, the average max percent signal change is reported. For other regions, the average max percent signal change is reported within a sphere centered at coordinates identified via previous research.|2 Weeks|There were 54 enrolled in the study. 8 subjects were excluded from fMRI analyses: 1 for claustrophobia, 3 for scanner artifact, 1 because of motion >3mm; 3 of paradigm-consistent motion which could not be corrected for.|||percent signal change||Standard Deviation|Mean
1239013|NCT00591773|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239014|NCT00591773|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 , defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239015|NCT00591773|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239016|NCT00591773|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239017|NCT00591773|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239018|NCT00591773|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239080|NCT00591344|Secondary|Magnitude of the Agonist Burst|Magnitude of the agonist burst reflects the amount of agonist activation during movement.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239019|NCT00591773|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239020|NCT00591773|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239021|NCT00591773|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239022|NCT00591773|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239023|NCT00591773|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239024|NCT00591773|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure.|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239025|NCT00591773|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239026|NCT00591773|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239027|NCT00591773|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239028|NCT00591760|Primary|Peak VO2|changes in peak VO2|6 months||||ml/kg/min||Standard Error|Mean
1239029|NCT00591734|Secondary|Objective Response Rate|The percentage of patients who experience an objective benefit from treatment|13 months|||||||
1239030|NCT00591734|Secondary|Overall Survival|The length of time, in months, that patients were alive from their first date of protocol treatment until death|18 months|||||||
1239031|NCT00591734|Primary|Progression-free Survival|Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|13 months||||months||95% Confidence Interval|Median
1239032|NCT00591721|Primary|Change From Baseline in Subscale Scores of the Fatigue Impact Scale|"Fatigue impact was measured using the Fatigue Impact Scale (FIS) (Fisk et al, 1994). This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rate each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score (range from 0 to 160) and three subscale scores (physical - 10 items, score range 0 to 40; psychosocial - 20 items, score range 0 to 80; cognitive - 10 items, score range 0-40) can be produced from participants’ responses. Higher scores reflect greater fatigue impact. What is reported here is the mean individual differences in the 7 week post subscale scores minus the baseline subscale scores"|baseline, 7 weeks (immediate post-intervention)|Intent-to-treat, imputation by maximum likelihood approach|||units on a scale||Standard Deviation|Mean
1239033|NCT00591591|Secondary|Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study||6 hours of sleep||||Number of apnea/hypopnea per sleep hour||Standard Deviation|Mean
1239034|NCT00591591|Primary|Deoxy-Hemoglobin Concentration in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.|||µM||Standard Deviation|Mean
1239035|NCT00591591|Primary|Total Hemoglobin Concentration in the Brain During Sleep||6 hours of sleep||||µM||Standard Deviation|Mean
1239036|NCT00591591|Primary|Oxyhemoglobin Concentration in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.|||µM||Standard Deviation|Mean
1239038|NCT00591578|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239039|NCT00591578|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239040|NCT00591578|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg.|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 24, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239041|NCT00591578|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239042|NCT00591578|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239043|NCT00591578|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239044|NCT00591578|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239045|NCT00591578|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239046|NCT00591578|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239047|NCT00591578|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239048|NCT00591578|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239049|NCT00591578|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239050|NCT00591578|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239052|NCT00591578|Primary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239053|NCT00591565|Primary|Change From Baseline at 8 Weeks in the HAM-A Scale|this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).|baseline and 8wk|LOCF if two initial visits were completed|||units on a scale||Standard Deviation|Mean
1239054|NCT00591370|Secondary|Duration of Objective Clinical Responses|Duration of Response (Objective Clinical Responses)|24 weeks after ending treatment||||months||Full Range|Median
1239055|NCT00591370|Secondary|Overall Survival|Overall survival at 18 months post treatment|18 months after ending treatment||||percentage of participants|||Number
1239056|NCT00591370|Primary|Determine the Overall Objective Response Rate (CR and PR).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From start of treatment through 24 weeks after ending treatment||||participants|||Number
1239057|NCT00591344|Secondary|5 Time Sit to Stand|The time it takes to stand up and sit down five times|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239058|NCT00591344|Secondary|50 Foot Walk Speed|The speed that aerson walks over 50 feet|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239059|NCT00591344|Secondary|50 ft Walk Time|Time it takes to walk 50 feet|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239060|NCT00591344|Secondary|Beck’s Depression Inventory|This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239061|NCT00591344|Secondary|Epworth Sleepiness Scale|The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239062|NCT00591344|Secondary|Parkinson ’s Disease Quality of Life|PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239063|NCT00591344|Secondary|Cognitive Function - Digit Span Forward/Backward|This tests a persons ability to remember that were read to them both forward and then backwards.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239064|NCT00591344|Secondary|Cognitive Function - Brief Test of Attention|This is a cognitive test of an individuals ability to remember number. It is a test of working memory.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239065|NCT00591344|Secondary|Cognitive Function - Stroop Test|This is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239066|NCT00591344|Secondary|Functional Reach|The distance one can reach forward without taking a step.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239067|NCT00591344|Secondary|Berg Balance Scale Score|This is a overall measure of balance|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239068|NCT00591344|Secondary|Time on the Timed up and go Test|This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239069|NCT00591344|Secondary|Modified Physical Performance Test|This is an overall measure of physical fuction|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239070|NCT00591344|Secondary|Distance Walked in 6 Minutes|This is how far an individual can walk in 6 minutes|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239071|NCT00591344|Secondary|Spatiotemporal Gait Analysis|Spatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239072|NCT00591344|Secondary|Rise Time|This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239073|NCT00591344|Secondary|Relaxation Time|Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239074|NCT00591344|Secondary|Peak Movement Velocity|This is how fast an individual can perform a 72 degree elbow flexion movement|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239075|NCT00591344|Secondary|Time to Peak Velocity|Time of the onset of the movement to peak velocity.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239076|NCT00591344|Secondary|Qant|The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239077|NCT00591344|Secondary|Co-contraction During Limb Acceleration|the amount of agonist and antagonist activity present during limb acceleration.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239078|NCT00591344|Secondary|Number of Agonist Bursts|This is the number of agonist bursts prior to peak velocity.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239183|NCT00590590|Secondary|Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort]||12 Weeks||||Score||Standard Error|Mean
1239081|NCT00591344|Secondary|Magnitude of the Antagonist Burst|the area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239082|NCT00591344|Secondary|Magnitude of the First 30 ms of the Agonist Burst|The integral of the first 30 msec of the agonist EMG.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239083|NCT00591344|Secondary|The Integral of the First Agonist Burst|The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239084|NCT00591344|Secondary|Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions|This is a measure of the percentage of the EMG signal that is contained in different frequency bins during a MVC (elbow flexion/extension; ankle DF/PF), a 50% of MVC elbow fleixon contraction, and a 5 NM elbow flexion contraction.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239085|NCT00591344|Secondary|Ankle Dorsiflexion Strength|This is a measure of the MVC for ankle dorsiflexion|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239086|NCT00591344|Secondary|Elbow Extension Strength|This is a measure of the MVC for elbow extension|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239087|NCT00591344|Secondary|Ankle Plantar Flexion Strength|This is a measure of the MVC for ankle plantar flexion strength|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239088|NCT00591344|Secondary|Elbow Flexion Strength|This is the MVC for elbow flexion|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
1239089|NCT00591344|Secondary|L-dopa equivalent-mg/Day|This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||mg/day||Standard Deviation|Mean
1239090|NCT00591344|Secondary|On Medication UPDRS-III|UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for the UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||units on a scale||Standard Deviation|Mean
1239091|NCT00591344|Primary|Off Medication UPDRS Part III, Motor Subscale Score|UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||units on a scale||Standard Deviation|Mean
1239092|NCT00591305|Secondary|Estradiol Level in Blood Post Treatment|determine side-effect by comparing Estradiol level in blood before and after treatment|5 month|failure for any meaningful analysis as only 1 participant in this study|||pg/ml|||Number
1239093|NCT00591305|Secondary|Estradiol Level in Blood Pre Treatment|determine side-effect by comparing Estradiol level in blood before and after treatment|Before treatment at baseline|failure for any meaningful analysis as only 1 participant in this study|||pg/ml|||Number
1239094|NCT00591305|Primary|Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months|vocal lesion size and area after 5 month with surgery visible lesion found in >50% of the treated tissue area, after surgery|Recurrence of pailloma at 5 months|participants received at least one of two interventions|||case|||Number
1239095|NCT00591266|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239096|NCT00591266|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239097|NCT00591266|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6 relative to baseline, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239098|NCT00591266|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239184|NCT00590590|Secondary|Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)|0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse|Baseline -12 Weeks||||Score||Standard Error|Mean
1239099|NCT00591266|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239100|NCT00591266|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239101|NCT00591266|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239102|NCT00591266|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239103|NCT00591266|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239104|NCT00591266|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239105|NCT00591266|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239106|NCT00591266|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239107|NCT00591266|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239108|NCT00591266|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239109|NCT00591266|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239110|NCT00591253|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239111|NCT00591253|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239145|NCT00590967|Secondary|Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis||5 years after completion of radiation therapy|The data was not collected for this secondary outcome. Due to the the early termination of this study, only data for the primary outcomes were collected and analyzed.||||||
1239112|NCT00591253|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
1239113|NCT00591253|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239114|NCT00591253|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239115|NCT00591253|Secondary|Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239116|NCT00591253|Secondary|Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239117|NCT00591253|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239118|NCT00591253|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239119|NCT00591253|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239120|NCT00591253|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239121|NCT00591253|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239122|NCT00591253|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239123|NCT00591253|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1239124|NCT00591253|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1239146|NCT00590967|Primary|Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status||1st PET scan after completion of treatment (approximately month 6)||||participants|||Number
1239147|NCT00590967|Primary|Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)||30 days after completion of radiation therapy||||participants|||Number
1239202|NCT00590460|Secondary|Patients With Treated Related Death|Number of patients with treated related death|100 days||||participants|||Number
1239125|NCT00591240|Primary|Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.|"Study 1: Multiplex pathogen identification using biosensor based assay. We recruited 116 participants yielding 109 urine samples suitable for analysis and comparison between biosensor assays and standard urine culture. Biosensor based assays were used to detect multiple pathogens in the urine samples.~Study 2: Antimicrobial susceptibility testing using biosensor based assay. We recruited 222 participants yielding 252 urine samples. Corresponding biosensor and clinical microbiology culture data was available for 215 samples. 73% (157) of these samples contained bacteria. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples."|Up to 1.5 years|Urine samples were collected from participants at the Spinal Cord Injury Service for assay validation.|||percentage of urine specimen|Participants||Number
1239126|NCT00591227|Primary|Hospital Length of Stay|hospital length of stay in days|days||||days||95% Confidence Interval|Mean
1239127|NCT00591227|Secondary|Frequency of Hypoglycemia During Emergency Room Therapy With Insulin||from emergency room admission to discharge|||||||
1239128|NCT00591227|Secondary|Efficacy of Blood Glucose Lowering During the Emergency Room Stay||from emergency room admission to discharge|||||||
1239129|NCT00591227|Secondary|Frequency of Hypoglycemia||from hospital admission to discharge|||||||
1239130|NCT00591227|Secondary|Average Blood Glucose During the Hospital Admission||from admission to discharge|||||||
1239131|NCT00591227|Primary|Length of Stay in the Hospital||from hospital admission to hospital discharge|||||||
1239132|NCT00591214|Secondary|Change in HCV RNA Levels of MP-424|"Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86.~Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose))."|Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86||||Log IU / mL||Standard Deviation|Mean
1239133|NCT00591214|Primary|t1/2 (Half Life Period) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||hours||Standard Deviation|Mean
1239134|NCT00591214|Primary|Ctrough (Plasma Trough Concentration) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||μg/mL||Standard Deviation|Mean
1239135|NCT00591214|Primary|AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||μg x h /mL||Standard Deviation|Mean
1239136|NCT00591214|Primary|Tmax (Time of Maximum Plasma Concentration) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||hours||Full Range|Median
1239137|NCT00591214|Primary|Cmax (Maximum Observed Concentration in Plasma) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||μg / mL||Standard Deviation|Mean
1239138|NCT00591149|Primary|Efficacy Measured by Response Rate in Participants|"Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI:~Complete Response (CR), Disappearance of all target lesions;~Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;~Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started;~Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|12 Weeks, 1 Year||||participants|||Number
1239139|NCT00591019|Secondary|Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.|Simple reaction time to an auditory signal is a measure of attention.|5 weeks||||milli seconds||Standard Error|Mean
1239140|NCT00591019|Primary|The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).|P50 is an auditory evoked response potential sensitive to states of arousal.|5 weeks||||milli volts||Standard Error|Mean
1239141|NCT00591006|Secondary|Para-Hippocampal Activation Differences Between Treatment Conditions||At the end of each treatment condition||||percentage of BOLD activation||Standard Deviation|Mean
1239142|NCT00591006|Secondary|Hippocampal Activation Differences Between Treatment Conditions||At the end of each treatment condition||||percentage of BOLD activation||Standard Deviation|Mean
1239143|NCT00591006|Primary|Difference in RAVLT Total T-Score Between Treatments|The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions, including short-term auditory-verbal memory, and retention of information. Test raw scores are converted to T-scores. T-scores have a mean of 30 ± 10 where higher scores are indicative of better verbal memory. Total T-score differences following study treatment interventions are reported.|At end of each treatment condition (on average 21 days between treatments)||||T-score||Standard Error|Mean
1239144|NCT00590980|Primary|Fatal and Nonfatal Ischemic Stroke in the Vertebrobasilar Territory|Definite fatal and nonfatal ischemic stroke in the vertebrobasilar territory|up to 27 months|Study participants meeting all inclusion and exclusion criteria|||Participants|||Count of Participants
1239181|NCT00590590|Secondary|Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be]||12 Weeks||||Score||Standard Error|Mean
1239148|NCT00590967|Primary|Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity|-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.|1 year post start of radiation therapy||||participants|||Number
1239149|NCT00590902|Primary|Overall Objective Response of OSI-774|(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|53 weeks||||participants|||Number
1239150|NCT00590889|Primary|Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.|Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.|1 year|subjects randomized into the study|||participants|||Number
1239151|NCT00590863|Secondary|Quality of Life Inventory|The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life.|Measured at Month 7||||units on a scale||Standard Deviation|Mean
1239152|NCT00590863|Primary|Quick Inventory of Depressive Symptoms|Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe).|Measured at Month 7|Remission = Last 2 QIDS < 6. A chi-square test was used to compare the remission rates across the treatment groups. The Fisher's exact test was used when expected cell frequencies were <5. For binary outcomes (e.g., remission), bivariate logistic regression models were fit to estimate the effect of treatment on outcome.|||percentage of participants|||Number
1239153|NCT00590772|Primary|Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks|"Daytime sleepiness was assessed on a scale of 0 (none) to 4 with 4 being severe.~To determine improvement of daytime sleepiness with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being maximal improvement.~To determine improvement of daytime fatigue with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being significant improvement.~For all three above we used data from the last 3 days were averaged and mean of change for each day."|baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1239154|NCT00590759|Secondary|A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.|Proportion of subjects in TAG 05-02 with MAEs|5 years||||participants|||Number
1239155|NCT00590759|Primary|Aneurysm Related Death|Freedom from aneurysm related mortality for TAG 05-02 subjects|5 years||||participants|||Number
1239156|NCT00590720|Secondary|Accumulation Index|Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528|Days 0 and 24|All participants who received at least one dose of MEDI-528 (n=7) and had available data (n=5).|||Ratio||Standard Deviation|Mean
1239157|NCT00590720|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.|||Day||Standard Deviation|Mean
1239158|NCT00590720|Secondary|Mean Trough Concentration at Last Measurable Time Point (Cmin_last)|Cmin_last of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.|||Microgram per milliliter||Standard Deviation|Mean
1239159|NCT00590720|Secondary|Mean Trough Concentration (Cmin)|Cmin of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.|||Microgram per milliliter||Standard Deviation|Mean
1239160|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Minutes||Standard Deviation|Mean
1239161|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Minutes||Standard Deviation|Mean
1239162|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=9, 2 placebo and 7 MEDI-528).|||Minutes||Standard Deviation|Mean
1239163|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 150|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).|||Liter x min||Standard Deviation|Mean
1239164|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 56|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).|||Liter x min||Standard Deviation|Mean
1239182|NCT00590590|Secondary|Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain]||12 weeks||||Score||Standard Error|Mean
1239165|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 28|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Liter x min||Standard Deviation|Mean
1239166|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Percent change||Standard Deviation|Mean
1239167|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Percent change||Standard Deviation|Mean
1239168|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, 2 placebo and 7 MEDI-528).|||Percent change||Standard Deviation|Mean
1239169|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Liter||Standard Deviation|Mean
1239170|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Liter||Standard Deviation|Mean
1239171|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, with 2 placebo and 7 MEDI-528).|||Liter||Standard Deviation|Mean
1239172|NCT00590720|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 119, and 150|All participants who received at least one dose of MEDI-528.|||Participants|||Number
1239173|NCT00590720|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 150|All participants who received at least one dose of investigational product (MEDI-528 or placebo).|||Participants|||Number
1239174|NCT00590720|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 150|All participants who received at least one dose of investigational product (MEDI-528 or placebo).|||Participants|||Number
1239175|NCT00590707|Secondary|Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score|"Clinical Dementia Rating consists of 6 domains (boxes) of function: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain (box) is rated on a 5-point scale (0= no impairment, 0.5=questionable impairment, 1= mild impairment, 2= moderated impairment, 3= severe impairment. The CDR-SOB score is a sum of these ratings, for a total Sum of boxes ranging from 0-18, where 0=cognitively intact. Increasing sum of boxes score is associated with greater cognitive impairment."|12 months post-operative||||units on a scale||Standard Deviation|Mean
1239176|NCT00590707|Secondary|Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method|The presence of delirium is assessed by the confusion assessment method (CAM), after 1 month postoperative. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.|1 month (30 days) post-intervention||||Participants|||Count of Participants
1239177|NCT00590707|Secondary|Mortality|death occurring during follow-up period, in one year post-op.|12 months post-operative||||Participants|||Count of Participants
1239178|NCT00590707|Secondary|Change in Functional Status|Ability to perform Activities of Daily Living (ADL) using 6-point Katz activities of daily living scale, assessed at 12 months post-op. The range of the Katz activities of daily living scale is from 0-6, 0 is worse and 6 is best.|12 months post-operative|ADL score at 1 year|||units on a scale||Standard Deviation|Mean
1239179|NCT00590707|Primary|Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method|The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.|Postoperative days up to hospital discharge||||Participants|||Count of Participants
1239180|NCT00590590|Secondary|Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe]||12 Weeks||||Score||Standard Error|Mean
1239185|NCT00590590|Primary|Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)|The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse|12 weeks||||scores on a scale||Standard Error|Mean
1239186|NCT00590577|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scores From Baseline to Week 13 or the Last Post-baseline Assessment|The CGI-S rating scale was used to assess the severity of a subject’s overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst. The change in CGI-S score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.|||Scores on a scale||Full Range|Median
1239187|NCT00590577|Secondary|Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 13 or the Last Post-baseline Assessment.|The PSP scale measures the degree of normal function of a subject in interpersonal relationships and social interactions. Scores range from 1 to 100, where 1 is worst and 100 is best. The average change in PSP score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.|||Scores on a scale||Standard Deviation|Mean
1239188|NCT00590577|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment|The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The primary outcome measure used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.|||Scores on a scale||Standard Deviation|Mean
1239189|NCT00590564|Primary|To Determine the Effects of Sho-saiko-to on Hepatic Injury in Patients With Chronic Hepatitis C Who Are Intolerant or Have a Specific Contraindication to Interferon-based Therapy.|Response is determined by improvement of 2 points or greater as per Knodell's histology activity index (HAI) scores in paired comparisons of pre and post liver biopsy|52 weeks||||participants|||Number
1239190|NCT00590538|Secondary|Number of Participants With Abnormal Laboratory Safety Tests|Outcome measure will be obtained by completion of routine metabolic and hematological laboratory parameters for every participant. Metabolic testing willl include a CMP (comprehensive metabolic panel, ALT (alanine aminotransferase test), GGT (gamma-glutamyl transpeptidase), and Uric Acid; Hematological testing will include a complete blood count (CBC), and partial thromboplastin (PT/PTT).|up to 2 weeks|No analysis was completed on data collected; More clinically efficacious compounds have been identified which suggested that completion of this study might not be as critical as when initially proposed; therefore, the study was terminated by PI.|||participants|||Number
1239191|NCT00590538|Secondary|Number of Participants With Adverse Events|Adverse Events will be assessed and outcome measure obtained by completion of Interval history, physical and mental status examinations of every participant.|up to 2 weeks||||participants|||Number
1239192|NCT00590538|Secondary|Change in FVC (Forced Vital Capacity)in Spirometry.|Outcome measure will be obtained from standard Pulmonary Function testing.|baseline and 2 weeks|No analysis was completed on data collected.|||Liters|||Number
1239193|NCT00590538|Secondary|Change in FEV1 (Forced Expiratory Volume in 1 Second) in Spirometry.|Outcome measure will be obtained from standard Pulmonary Function testing.|baseline and 2 weeks|No analysis was completed on data collected.|||Liters|||Number
1239194|NCT00590538|Primary|Change in Voltage (mVolt) in Nasal Epithelium|"The basis of analysis for the primary outcome measure will be the comparison of data from both the standard CF Nasal Potential Difference (NPD) Protocol compared to a modified NPD protocol including the perfusion of Genistein.~The NPD response will be compared from baseline to after study drug. NPD responses will then be compared between the Phenylbutrate group and the placebo group."|Baseline and 2 weeks|No analysis was completed on data collected; AND study was never unblinded therefore details not available.|||mVolts|||Number
1239195|NCT00590460|Secondary|Patients With Grade III - IV Acute GVHD|Number of patients with Grade III-IV acute GVHD|100 days||||participants|||Number
1239196|NCT00590460|Secondary|Patients With Extensive Chronic GVHD From Day 100 to 365|Number of patients with extensive chronic GVHD from day 100 to 365.|365 days||||participants|||Number
1239197|NCT00590460|Secondary|Patients With Limited Chronic GVHD From Day 100 to 365|Number of patients with limited chronic GVHD from day 100 to 365|365 days||||participants|||Number
1239198|NCT00590460|Secondary|Number of Patients Alive at 1 Year Post Transplant|Number of patients alive at 1 year post allogeneic stem cell transplant|1 year||||participants|||Number
1239199|NCT00590460|Secondary|Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD)|Number of patients with grade II - IV acute Graft versus Host Disease (GVHD)|100 days||||participants|||Number
1239200|NCT00590460|Secondary|Days to Platelet Count of 20,000/mm3 Without Transfusions|Number of days to Platelet count of 20,000 / mm3 without transfusions|30 Days|Participants achieved a platelet count of 20,000 / mm3 without transfusions.|||days||Full Range|Median
1239201|NCT00590460|Secondary|Days to Absolute Neutrophil Count (ANC) of 500/mm3|Number of days to Absolute neutrophil count (ANC) of 500/mm3|30 Days||||days||Full Range|Median
1239208|NCT00590369|Secondary|Ease of Providing Nursing Care|nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem|during hospital stay; generally 6 days||||scores on a scale||Inter-Quartile Range|Median
1239209|NCT00590369|Secondary|Ease of Performing Dressing Change|responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do|during hospital stay; generally 6 days||||scores on a scale||Inter-Quartile Range|Median
1239210|NCT00590369|Primary|5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling|differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler|first dressing change; typically within 48 hours||||centimeters||Inter-Quartile Range|Median
1239211|NCT00590317|Secondary|Akithisia at 0 to 120 Min||0 to 120 min after receiving medication||||no. participants exp akathisia|||Number
1239212|NCT00590317|Secondary|Nausea at 0 to 120 Min|100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea|0 to 120 minutes after receiving medication||||units on a scale||Standard Deviation|Geometric Mean
1239213|NCT00590317|Primary|Vomiting at 0 to 120 Min.||0 to 120 minutes after receiving medication|Convenience sample|||number of participants exp vomiting|||Number
1239214|NCT00590226|Secondary|Number of Patients With Hypoglycemic Events|number of patients with hypoglycemic events as defined as BG 40-59 mg/dl|during hospitalization||||participants|||Number
1239215|NCT00590226|Primary|Mean AM BG (mg/dl)|average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2|during hospitalization||||mg/dl||Standard Deviation|Mean
1239216|NCT00590161|Primary|Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year.|The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and balloning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).|1 year (Baseline liver biopsy done at study entry, and subsequent liver biopsy done after one year of therapy with pentoxifylline or placebo)|Intention to treat analysis included all participants and for this analysis patients without available end of study liver biopsy were imputed as treatment failures. Results showed here are continuous variable analysis of NAS score change in patients with available end of study liver biopsy (per protocol analysis)|||NAS score units||Standard Deviation|Mean
1239217|NCT00590135|Secondary|Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.||||||
1239218|NCT00590135|Secondary|Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.||||||
1239219|NCT00590135|Secondary|Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.||||||
1239220|NCT00590135|Secondary|Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls|Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls was not obtained. Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.|2 years|Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.||||||
1239221|NCT00590135|Primary|Aortic Stenosis|aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility|2 years|Population had aortic stenosis, however the primary endpoint of Aortic Valve Area was not obtainable due to poor reproducibility. As a result, the study was terminated.||||||
1239222|NCT00590044|Secondary|Difference in Time in Hours to Resolution of DKA Between the 2 Groups|The mean duration of treatment until resolution of ketoacidosis is measured and compared between the 2 groups. The DKA was considered resolved when blood glucose was 250 mg/dl, the serum bicarbonate level was <18 mmol/l, and venous phenol hydroxylase (pH) was 7.30. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.|up to 20 hours||||hours||Standard Deviation|Mean
1239292|NCT00589563|Secondary|Non-relapse Mortality at 100 Days Post HSCT|Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.|100 day point estimate was provided||||Percentage of patients with a NRM||95% Confidence Interval|Number
1239223|NCT00590044|Secondary|Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups|To determine the differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA) before transitioning to subcutaneous insulin. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.|up to 20 hours||||mg/dL||Standard Deviation|Mean
1239224|NCT00590044|Secondary|Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin|The primary outcome during the subcutaneous (SC) period (the primary outcome measurement) was to determine differences in glycemic control as measured by mean daily blood glucose(BG) concentration between treatment groups. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed Identification (ID): 19366972.|Day1 - Day5 after the resolution of ketoacidosis and transition to subcutaneous insulin||||mg/dl||Standard Deviation|Mean
1239225|NCT00590044|Primary|Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups|To determine the safety of the two treatments the number of hypoglycemia episodes that occurred between the 2 groups are measured from the time of transitioning to subcutaneous insulin to day 5. The hypoglycemia events are defined as blood glucose levels <70 mg/dL. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.|5 days after transitioning to subcutaneous insulin||||number of hypoglycemia episodes|||Number
1239226|NCT00590031|Secondary|Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality||2 years||||participants|||Number
1239227|NCT00590031|Primary|Pathologic Complete Response|Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject’s best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.|2 years||||participants|||Number
1239228|NCT00590018|Secondary|Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.|Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15). A lower inotrope score is better with the minimum being 0 and the maximum being 85.|2 days||||units on a scale||Standard Deviation|Mean
1239229|NCT00590018|Primary|Blood Pressure.|Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).|2 days||||mmHg||Standard Deviation|Mean
1239230|NCT00590005|Secondary|Reduction in Breath pH|Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.|baseline and 21 days|225 children with asthma were enrolled in the study and completed baseline assessments. Only 40 children were followed longitudinally. The data from those 40 children are shown here.|||log of hydrogen ion concentration (pH)||Standard Deviation|Mean
1239231|NCT00590005|Primary|Exhaled Nitric Oxide at Baseline and Over the Observational Period|Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag|baseline and after 21 days|225 children were enrolled into the study and completed baseline assessments. Only 40 children were followed longitudinally. The results from only those 40 children are shown here.|||parts per billion||Standard Deviation|Mean
1239232|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale|The VSH Sleep Scale is contained in a 15 item self-report instrument that measures the quality of a patient’s sleep over the last 24 hours. Each item is scored on a 0-100 visual analog scale. The VSH is categorized into 3 sleep scales: disturbance (which measures delays and interruptions in sleep)[maximum score = 700], effectiveness (which measures how well sleep refreshed the individual) [maximum score = 600], and supplementation (which measures the need for napping) [maximum score = 400]. The higher the score the greater the value of the sleep characteristic for that patient.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
1239233|NCT00589979|Other Pre-specified|Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Categories included Better, Much the Same, and Worse.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
1239234|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Values of the continuous EQ-5D health state today (VAS) ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
1239235|NCT00589979|Secondary|Investigator Global Assessment of Treatment Satisfaction|At the end of each period, investigators rated their overall satisfaction with study treatment using a 5-point categorical scale ranging from 0 (very dissatisfied) to 4 (very satisfied).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
1239236|NCT00589979|Secondary|Patient Global Assessment of Treatment Satisfaction|At the end of each period, patients rated their overall satisfaction with study treatment using a 5-point categorical scale indicating: 0 - very dissatisfied; 1 - dissatisfied; 2 - no preference; 3 - satisfied; and 4 - very satisfied.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
1239237|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline (Day 0) and at each clinic visit (at least every 4 weeks) or at premature discontinuation. Values of the EQ-5D index score range from -1 (worst) to 1 (best).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
1239238|NCT00589979|Other Pre-specified|Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score|The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.|Screening, Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
1239239|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score|The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.|Baseline and end of treatment period (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
1239240|NCT00589979|Secondary|Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain|"Investigators rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale ranging from very much worse to very much improved. A similar questionnaire was completed by the Investigator."|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
1239241|NCT00589979|Secondary|Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain|"Patients rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale indicating: very much worse (0); much worse (1); minimally worse (2); no change (3); minimally improved (4); much improved (5); and very much improved (6)."|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
1239293|NCT00589563|Secondary|Occurence of Sinusoidal Obstructive Syndrome (SOS)|Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS.|Median Follow Up: 28 Months (Range: 1-49 Months)||||participants|||Number
1239242|NCT00589979|Secondary|Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores|The PQAS measures individual pain qualities and the impact of treatment on those qualities. Items 1-19 are each rated on an 11-point scale ranging from 0 (lowest score - no pain of that type) to 10 (highest score - the highest level of that type of pain). Average surface pain = average of PQAS items: cold, sensitive, itchy, numb, and tingling. Average deep pain = average of PQAS items: dull, cramping, throbbing, aching, and heavy. Average paroxymal pain = average of PQAS items: sharp, shooting, electric, and radiating.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
1239243|NCT00589979|Secondary|Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores|The Pain Relief Scale (PRS) is a 9-point categorical rating scale to assess pain relief during the 24-hours since the last assessment; 0= completely worse and 8= complete pain relief. Patients completed this assessment each day during the run-in period and each day during the double-blind treatment phase in their e-diary.|Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
1239244|NCT00589979|Secondary|Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)|"The Numerical Rating Scale (NRS) is an 11-point categorical rating scale to assess pain intensity (PI-NRS); 0= no pain and 10= worst possible pain. The scale is anchored on the left with No Pain and on the right with Worst Possible Pain. Patients were to complete this assessment at approximately the same time each day during the double-blind treatment period in their e-diary. The overall treatment difference for the Lidoderm (lidocaine patch 5%) and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence."|Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
1239245|NCT00589979|Secondary|Exit Status From Current Study Treatment - Yes|Exit status from a current study treatment was categorized as yes or no for patients who exited prior to the 4-week planned duration. This analysis supports the results of the primary analysis. The number of patients exiting (yes) is reported.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
1239246|NCT00589979|Secondary|Time-to-Exit Due to Lack of Efficacy|"Time-to-exit due to lack of efficacy was defined as a patient that met the switching criterion (a 2-category change in Pain Relief Scale (PRS) in the worsening direction [increasing pain or decreasing pain relief] for 2 consecutive days) or was discontinued from the current period or study due to lack of efficacy. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief.~No patients discontinued from the study due to lack of efficacy."|Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|"The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.~Note: No patients exited a study period due to lack of efficacy, therefore median time-to-exit could not be calculated."|||days||95% Confidence Interval|Median
1239247|NCT00589979|Primary|Time-to-Exit From Current Study Treatment|Time-to-exit was defined as the number of days at which a patient either met the switching criterion [a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. median survival time) as independent and homogeneous across patients were not suitable for this study.|Baseline, Period 1 (up to 4 weeks ±2 days), Period 2 (up to 4 weeks ±2 days), Period 3 (up to 4 weeks ±2 days), or Premature Discontinuation|"The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.~Note: Kaplan-Meier estimates for median time-to-exit from current study treatment could not be calculated for Period 2 or Period 3, because the survival distribution function did not fall below 0.5000."|||Days||95% Confidence Interval|Median
1239248|NCT00589914|Secondary|The Change From Baseline in the PSP Score|The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)|The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.|||Scores on a scale||Standard Deviation|Mean
1239294|NCT00589563|Secondary|Occurrence of Thrombotic Microangiopathy|Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.|Median Follow Up: 28 Months (Range: 1-49 months)||||participants|||Number
1239249|NCT00589914|Secondary|The Change From Baseline for the CGI-S Score|The CGI-S rating scale is used to rate the severity of a patient’s psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient’s condition at a given time. A qualified rater administered the CGI-S.|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]|The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.|||Scores on a scale||Standard Deviation|Mean
1239250|NCT00589914|Primary|Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia|The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)|The per-protocol analysis set of patients included those randomized to treatment after IEC/ IRB approval of protocol Amendment INT-4 with both a baseline measurement and at least 1 postrandomization measurement on the primary efficacy variable, a minimum exposure of 36 days to the double-blind treatment regimen, and no major protocol violations.|||Scores on a scale||Standard Deviation|Mean
1239251|NCT00589888|Secondary|Change in Blood Insulin Levels From Baseline to After Intervention Among the Normal Obese Subjects|Insulin is an anabolic hormone that promotes glucose uptake, glycogenesis, lipogenesis, and protein synthesis of skeletal muscle and fat tissue through the tyrosine kinase receptor pathway. In addition, insulin is the most important factor in the regulation of plasma glucose homeostasis, as it counteracts glucagon and other catabolic hormones like epinephrine, glucocorticoid, and growth hormone. Normal fasting insulin levels is < 25 milli-International unit/litre|Baseline and at the end of the 8-hours|the same 13 subjects underwent different interventions in random order on different occasions|||milli-International unit /Litre||Standard Deviation|Mean
1239252|NCT00589888|Secondary|Change in C-peptide Concentration Levels From Baseline to After Specific Intervention Among the Healthy Obese Subjects|C-peptide is a peptide composed of 31 amino acids. It is released from the pancreatic beta-cells during cleavage of insulin from proinsulin. It is mainly excreted by the kidney, and its half-life is 3-4 times longer than that of insulin. The reference range of C-peptide is 0. 8-3 ng/ml. The C-peptide test is a tool to monitor and treat diabetes. It shows how well your body makes insulin, which moves sugar (or “glucose”) from your blood into your cells.|baseline and after 8 hours after admission||||ng/ml||Standard Deviation|Mean
1239253|NCT00589888|Secondary|Change in Blood Glucose Levels From Baseline to 6-8 Hours After Intervention Among Obese Healthy Subjects|The blood glucose level is the amount of glucose present in the blood of humans. Many factors affect a person's blood sugar level. The body's homeostatic mechanism of blood sugar regulation (known as glucose homeostasis), when operating normally, restores the blood sugar level to a narrow range of about 4.4 to 6.1 mmol/L (79 to 110 mg/dL) (as measured by a fasting blood glucose test). The study aims to study the effects of these interventions on blood glucose levels among obese healthy subjects.|Baseline and at the end of the 8-hours||||mg/dL||Standard Deviation|Mean
1239254|NCT00589888|Secondary|Change in Flow-mediated Dilation (FMD) of Endothelium-dependent Brachial Artery From Baseline to After Completing a Specific Intervention in Obese Normotensive Subjects.|Endothelium-dependent brachial artery dilatation was assessed as a measurement of endothelial function using established methodology. Briefly, ultrasound images of the brachial artery were obtained at baseline under standardized conditions and 60 s after induction of reactive hyperemia by 5-min cuff occlusion of the forearm. Image landmarks as well as surface markers were utilized to ensure anatomic consistency between serial imaging studies. All images were digitized online, and arterial diameters were measured with customized software by individuals blinded to the clinical and laboratory status of the subjects. Flow-mediated dilatation (FMD) was expressed as the percentage increase in diameter from baseline. It is measured in percentage.|Baseline and at the end of the 8-hours||||percentage of FMD||Standard Deviation|Mean
1239255|NCT00589888|Primary|Changes in Systolic Blood Pressure From Baseline to After Completing an Oral 64-gram Fat Load in Obese Normotensive Subjects|To study the effects of high dose oral fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|at the end of the 8 hours||||mmHg||Standard Deviation|Mean
1239256|NCT00589888|Primary|Change in Systolic Blood Pressure From Baseline to After Completing an Oral 32-gram Fat Load in Obese Normotensive Subjects.|To study the effects of oral low dose fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position.The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|Baseline and at the end of the 8-hours||||mmHg||Standard Deviation|Mean
1239257|NCT00589888|Primary|Changes in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 40cc/hr Infusion in Obese Normotensive Subjects|To study the effects of high dose intravenous (IV) fat infusion on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at every 2 hours till the end of infusion. The BP from the admission are compared to BP after the infusion. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|Baseline and at the end of the 8-hours||||mmHg||Standard Deviation|Mean
1239258|NCT00589888|Primary|Change in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 20cc/hr Infusion in Obese Normotensive Subjects.|To study the effects of low dose intravenous (IV) fat infusion on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at every 2 hours till the end of infusion. The BP from the admission are compared to BP after the infusion.A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|Baseline and at the end of the 8-hours||||mmHg||Standard Deviation|Mean
1239259|NCT00589888|Primary|Change in Systolic Blood Pressure to After Completing an 8-hour Normal Saline Infusion in Obese Normotensive Subjects.|To study the effects of high dose oral fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|Baseline and at the end of the 8-hours||||mmHg||Standard Deviation|Mean
1239260|NCT00589849|Primary|Event Free Survival at 1 Year|Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year|12 months||||participants|||Number
1239261|NCT00589849|Primary|Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI||30 days|||||||
1239262|NCT00589836|Primary|Accuracy of Doppler Tissue Imaging|"The purpose of the present study was to examine the accuracy of a novel method with DTI for quantifying the LV torsion in humans and tagged MRI as the reference standard.~LV torsion reflects the torsion (twisting deformation) occurring across the length of the ventricle (from the base to the apex) during the time interval defined by the beginning and end of contraction (or in physiologic terms, from end -diastole to end systole). In this study, end diastole was defined by the R wave of the ECG, while end systole is defined by minimum end-systolic volume or maximum of twisting deformation. The deformation is measured in degrees.~Once the measurements are performed by experimental method (i.e. TDI imaging) and reference method (i.e. MRI imaging) these two methods are then compared using Bland Altman analysis.~In a current study, mean difference between methods of torsion quantification was 0.57 degrees, while the standard deviation (SD) was 1.98 degrees."|1 1/2 hours|population had both MRI and DTI on the same day.|||degrees||Standard Deviation|Mean
1239263|NCT00589797|Secondary|Improvement in SF-36 Scores|Number of subjects demonstrating a greater than or equal to 15% improvement in mental (MCS) and physical (PCS) component summary scores at 24 months compared to baseline|24 months|Intent to treat population; observational data (i.e. missing data not imputed as failures)|||participants|||Number
1239264|NCT00589797|Secondary|ODI Success Using Two Measures of Success|Number of subjects demonstrating improvement in two measures of ODI success at 24 months compared to baseline|24 months|Intent to treat population; observational data (i.e. missing data not imputed as failures)|||participants|||Number
1239265|NCT00589797|Primary|ODI Success|Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
1239266|NCT00589797|Primary|Neurological Success|Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
1239267|NCT00589797|Primary|Range of Motion (ROM) Success|Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
1239268|NCT00589797|Primary|Absence of Serious Device Related Adverse Events|Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC)|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
1239269|NCT00589797|Primary|Device Success|Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months.|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
1239270|NCT00589797|Secondary|VAS Success for Back and Leg Pain at Rest|Number of patients demonstrating improvement in back and leg pain at 24 months compared to baseline|24 months|Intent to treat population; observed data (i.e. missing data not imputed as failures)|||participants|||Number
1239271|NCT00589797|Primary|Overall Success at 24 Months Relative to Baseline|Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score.|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
1239272|NCT00589784|Primary|Overall Objective Response|Determine the overall objective response|1.5 years||||participants|||Number
1239273|NCT00589693|Secondary|28-day All-cause Mortality Rate|Number of deaths which occured up to 28 days of the study period due to all causes|Up to 28 days|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
1239274|NCT00589693|Secondary|Number of Patients Who Had Emergence of P. Aeruginosa Resistance|Number of patients who had P. aeruginosa isolates with a 4 fold or greater increase in minimum inhibitory concentration (MIC) at anytime during the study (after the study medication is received) from baseline|Up to 6 weeks|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
1239295|NCT00589563|Secondary|Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation|Participants were monitored throughout the trial (median of 28 months) for various infections/complications.|Median Follow Up: 28 months (Range: 1-49 months)||||participants|||Number
1239275|NCT00589693|Secondary|Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline|The clinical cure rate at the EOT visit in patients whose BAL or mini-BAL culture results yielded at least 1 of the following Gram-negative qualifying pneumonia pathogens was isolated at baseline: any Enterobacteriaceae, P. aeruginosa, and Acinetobacter Spp.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
1239276|NCT00589693|Secondary|Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline|The clinical cure rate at the EOT visit in patients, whose bronchoalveolar lavage (BAL) or mini-BAL culture results yielded qualifying pneumonia pathogen P. aeruginosa at baseline.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
1239277|NCT00589693|Primary|Clinical Cure Rate at the End-of-treatment (EOT) Visit|The number of patients who achieved clinical cure at the EOT visit on Day 10. The patient's were classified as clinical cure if they had resolution of signs and symptoms and objective findings of pneumonia to such an extent that no further antimicrobial therapy was necessary.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
1239278|NCT00589667|Secondary|Median Overall Survival|To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine.|2 years|There were 25 assessable patients as described in the protocol.|||months||Full Range|Median
1239279|NCT00589667|Primary|Overall Objective Response|"To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|All assessable patients as indicated in the protocol.|||participants|||Number
1239280|NCT00589628|Primary|Effects of Infliximab on Uveitis Disease Activity.|Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.|9 months|1 subject lost to follow up|||participants|||Number
1239281|NCT00589602|Secondary|Number of Participants With Relapse-free Survival|number of patients that were still alive and relapse free|after 7 years of follow up|All patients that received treatment|||participants|||Number
1239282|NCT00589602|Secondary|Number of Participants Able to Receive T-cell Add Backs|Patients receive defined doses of donor T cells by IV infusion on days 45 and 100, in absence of active graft-versus-host disease (GVHD) requiring steroids.|through D+100||||participants|||Number
1239283|NCT00589602|Secondary|Number of Participants With Duration of Absolute Neutropenia||D+100 from transplant||||participants|||Number
1239284|NCT00589602|Secondary|The Rate of Acute Graft Versus Host Disease (GVHD)||D+100 from transplant||||participants|||Number
1239285|NCT00589602|Primary|Treatment-related Mortality (TRM)|The complication rate in matched unrelated donor (MUD) allogeneic bone marrow transplant (allo BMT) is known to be high. Graft failure and severe graft versus host disease (GvHD) are the most significant contributors to treatment related mortality (TRM). This treatment regimen will be considered unacceptable if the number of patients that experience TRM is 55% or greater, and effective if TRM is 33% or less.|180 days after transplant|Patients that received treatment|||participants|||Number
1239286|NCT00589563|Secondary|Incidence of Disease Relapse/Progression at 2 Years Post HSCT|Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment.|2 year point estimate was provided.||||Percentage of patients who relapsed||95% Confidence Interval|Number
1239287|NCT00589563|Primary|Severity of Chronic GVHD|All Patients were considered for the evaluation of chronic GVHD severity.|Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT||||participants|||Number
1239288|NCT00589563|Primary|Cumulative Incidence of Chronic GVHD|Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment.|2 year point estimate was provided.||||Percentage of patients developing cGVHD||95% Confidence Interval|Number
1239289|NCT00589563|Secondary|Event Free Survival at Two Years Post HSCT|Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event.|2 year point estimate was provided.||||Percentage of patients with an event||95% Confidence Interval|Number
1239290|NCT00589563|Secondary|Overall Survival at Two Years Post HSCT|Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date.|2 year point estimate was provided.||||Percentage of patients who died||95% Confidence Interval|Number
1239291|NCT00589563|Secondary|Non-relapse Mortality at Two Years Post HSCT|Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.|2 year point estimate was provided.||||Percentage of patients with a NRM||95% Confidence Interval|Number
1239324|NCT00589303|Primary|Cardiac Hospitalization Within Six Months of Enrollment|Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.|Six months after enrollment|Intent-to-treat|||participants|||Number
1239296|NCT00589563|Secondary|Time to Platelet Count Recovery (Engraftment)|Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10^9 L obtained on different days.|Patients were evaluated until platelet recovery, a median of 14 days|27 of the 32 patients had platelet recovery.|||Days||Full Range|Median
1239297|NCT00589563|Secondary|Time to Absolute Neutrophil Count Recovery (Engraftment)|Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10^9/L (500/mm3) for three consecutive laboratory values obtained on different days|Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT|28 of the 32 patients had absolute neutrophil count recovery.|||Days||Full Range|Median
1239298|NCT00589563|Primary|Severity of Acute GVHD|All patients were considered for the evaluation of the severity of acute GVHD.|100 Days Post HSCT||||participants|||Number
1239299|NCT00589563|Primary|Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100|Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.|100 Days Post Hematopoietic Stem Cell Transplant (HSCT)||||Percentage of patients developing aGVHD||95% Confidence Interval|Number
1239300|NCT00589550|Secondary|Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood||Up to 1 year|||||||
1239301|NCT00589550|Secondary|Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome||up to 1 year|||||||
1239302|NCT00589550|Secondary|Overall Survival||up to 1 year|||||||
1239303|NCT00589550|Secondary|Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.||up to 1 year|||||||
1239304|NCT00589550|Secondary|Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.||up to 1 year|||||||
1239305|NCT00589550|Primary|Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.||up to 2 months|||||||
1239306|NCT00589550|Primary|Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate||up to 2 months|||||||
1239307|NCT00589472|Other Pre-specified|Levels of DHEA-S in Prostate Tissue||Up to 1 year|||||||
1239308|NCT00589472|Other Pre-specified|Levels of DHEA in Prostate Tissue||Up to 1 year|||||||
1239309|NCT00589472|Other Pre-specified|Levels of Androstenedione in Prostate Tissue||Up to 1 year|||||||
1239310|NCT00589472|Other Pre-specified|Levels of Androstenediol in Prostate Tissue||Up to 1 year|||||||
1239311|NCT00589472|Other Pre-specified|Levels of DHT in Prostate Tissue||Up to 1 year|||||||
1239312|NCT00589472|Other Pre-specified|Levels of Testosterone in Prostate Tissue||Up to 1 year|||||||
1239313|NCT00589472|Other Pre-specified|Gene Microarray Analysis||Up to 1 year|||||||
1239314|NCT00589472|Other Pre-specified|Gene Expression Analysis, Including AR Target Genes, PSA and TMPRSS2|Estimates and 95% confidence intervals for the proportion of patients with nondetectable levels of PSA and TMPRSS2 will be computed.|at 12 weeks|||||||
1239315|NCT00589472|Other Pre-specified|Safety and Tolerability of Androgen Depletion Therapy in Combination With Vorinostat as Assessed by Physical Examinations, Adverse Events, and Laboratory Assessments. Please See Adverse Events Section.|Adverse events will be monitored at each scheduled visit and throughout the study. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Up to 1 year|||||||
1239316|NCT00589472|Other Pre-specified|Protein Expression Analysis, Including AR Target Genes, PSA and TMPRSS2||Up to 1 year|||||||
1239317|NCT00589472|Secondary|Levels of Testosterone in Blood From Radical Prostatectomy Specimens||Up to 1 year||||ng/dL||95% Confidence Interval|Median
1239318|NCT00589472|Secondary|Levels of PSA in Blood From Radical Prostatectomy Specimens||Up to 1 year||||ng/mL||95% Confidence Interval|Median
1239319|NCT00589472|Secondary|Levels of DHT in Blood From Radical Prostatectomy Specimens||Up to 1 year||||ng/dL||95% Confidence Interval|Median
1239320|NCT00589472|Secondary|Levels of DHEA-S in Blood From Radical Prostatectomy Specimens||Up to 1 year||||mcg/dL||95% Confidence Interval|Median
1239321|NCT00589472|Secondary|Levels of DHEA in Blood From Radical Prostatectomy Specimens||Up to 1 year||||ng/dL||95% Confidence Interval|Median
1239322|NCT00589472|Secondary|Gleason Score|A Gleason score is the sum of two numbers. Pathologist determines where the cancer is most prominent and assigns the primary grade, the secondary grade is assigned based on where the cancer is next most prominent. A score from one to five is assigned for each area based on how aggressive the tumor appears. A tumor with cell that appear close to normal is assigned a low Gleason score (six or below). A tumor with cells that appear clearly different from those of a normal prostate is assigned a high Gleason score (seven or above). A system of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is more likely to spread.|Baseline||||units on a scale||95% Confidence Interval|Median
1239323|NCT00589472|Primary|Pathologic Complete Response at the Time of Surgery|The primary endpoint will be pathologic complete response at the time of surgery. This represents the proportion of patients with no evidence of disease in the prostate (ie, the absence of tumor in the posttherapy pathology specimen) at the time of radical prostatectomy. Pathologic complete response at the time of surgery is the primary endpoint for this study. A Simon 2-stage optimal design that differentiates between response probabilities of 0.05 and 0.20 will be used in the analysis of the pathological complete response at 12 weeks (Type I error 10% and power 90%). A maximum of 38 pts were planned for accrual onto this study. If zero or one response was observed, then the trial was to be stopped. The design had power 0.90 for a population response proportion to 0.20 using a one-sided 0.10 size test. pT2 indicates that the cancer is confined to the prostate, while pT3 indicates that there is an extraprostatic extension of the cancer.|At 12 weeks||||Participants|||Count of Participants
1239325|NCT00589290|Primary|Chromosomal Gains or Losses in Comparative Genomic Hydridization in Thymoma and Thymic Cancer|Utilize a patients tumor tissue to determine if there is any correlation between chromosomal gains or losses in comparative genomic hybridization in thymoma and thymic carcinomas and clinical outcomes.|46 months|Unpublished data from Dr. Giaccone's lab does not reveal an association between these parameters and outcomes in patients with thymic malignancies. Hence we do not plan to perform analyses for these outcome measures and there is no known negative clinical implications associated with this.||||||
1239326|NCT00589290|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|26 months||||Participants|||Number
1239327|NCT00589290|Primary|Number of Participants With a Partial Response|Response is defined by the Response Evaluation Criteria in Solid Tumor (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. For additional details about the RECIST criteria see the protocol Link module.|25.5 months||||Participants|||Number
1239328|NCT00589277|Secondary|7 Day Abstinence|The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.|3 month follow up|Per protocol|||participants|||Number
1239329|NCT00589277|Secondary|24 Hour Abstinence|The number of survey respondents that had abstained from smoking at the 2 week follow up.|2 week follow up|Per protocol|||participants|||Number
1239330|NCT00589277|Primary|Quit Attempt|Percentage of those that self reported attempting to quit smoking at the 2 week follow up.|2 week follow up|Per protocol|||participants|||Number
1239331|NCT00589121|Other Pre-specified|Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients||2 years after start of treatment (+/- 3 months)|||||||
1239332|NCT00589121|Other Pre-specified|Comparison of TESS and the MSTS Scores at 2 Years Between Cohort B Patients and the Preoperative Radiotherapy Patients in the NCIC CTG Trial [National Cancer Institute of Canada Clinical Trials Group]||2 years after start of treatment (+/- 3 months)|||||||
1239333|NCT00589121|Other Pre-specified|Correlation of Late Radiation Morbidity at 2 Years With the 3 Quality of Life Assessments [Functional Assessment of Cancer Therapy-General (FACTG), Toronto Extremity Salvage Score (TESS), and Sexual Adjustment Questionnaire (SAQ)]||2 years after start of treatment (+/- 3 months)|||||||
1239334|NCT00589121|Secondary|Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of patients||95% Confidence Interval|Number
1239335|NCT00589121|Secondary|Impact of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years on the Clinical Measure, Musculoskeletal Tumor Rating Scale (MSTS)||2 years after start of treatment (+/- 3 months)|||||||
1239336|NCT00589121|Secondary|Pattern of First Failure|Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.|From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. All eligible patients on Cohort B. (See limitations and caveats, Cohort A is not included.)|||participants|||Number
1239337|NCT00589121|Secondary|Percentage of Patients With Wound Complications|Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.|From date of surgery to 4 months post-surgery|All eligible patients on cohort B that had surgery and a wound assessment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239338|NCT00589121|Secondary|Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|2 years after start of treatment (+/- 3 months)|All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239339|NCT00589121|Secondary|Second Primary Tumor Rate at Two Years|Second primary tumor is defined as the time from registration to date of failure (second primary tumor) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239340|NCT00589121|Secondary|Overall Survival Rate at Two Years|Overall survival is defined as the time from registration to date of death or last follow-up. Two year survival rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239341|NCT00589121|Secondary|Disease-free Survival Rate at Two Years|Disease-free survival is defined as the time from registration to date of failure (local, regional, or distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of failure (local, regional or distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239342|NCT00589121|Secondary|Distant Disease-free Survival Rate at Two Years|Distant disease-free survival is defined as the time from registration to date of failure (distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239343|NCT00589121|Secondary|Distant Failure Rate at Two Years|Distant failure is defined as the time from registration to date of failure (distant progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239344|NCT00589121|Secondary|Regional Failure Rate at Two Years|Regional failure is defined as the time from registration to date of failure (regional progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239345|NCT00589121|Secondary|Local Failure Rate at Two Years|Local failure is defined as the time from registration to date of failure (local progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239346|NCT00589121|Primary|Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria|The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.|2 years after start of treatment (+/- 3 months)|All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
1239347|NCT00589108|Secondary|Percentage of Knees Surviving at 5 Years|Kaplan-Meier analysis of five-year implant survival rate|5 years post-surgery||||percentage of knees|||Number
1239348|NCT00589108|Secondary|Knee Society Stair Climbing Score|The stair-climbing portion of the Knee Society clinical rating system assigns a maximum score of 50 points for patients able to ascend and descend stairs in a normal fashion, 40 points for patients needing a rail to descend, 30 points for patients using a rail in both directions, 15 points for patients able to ascend but not descend at all, and 0 points for patients unable ascend or descend. Because stair ascent and descent put substantial demands on the patellofemoral joint, we used that portion of the Knee Society clinical rating system as a proxy for patellofemoral function in this study.|two years post-surgery, five years post-surgery||||units on a scale||Full Range|Mean
1239349|NCT00589108|Secondary|Knee Society Pain Score|The Knee Society Pain Score includes walking and climbing stairs. The maximum score per knee is 50 indicating no pain, and 0 indicates severe pain. Therefore the total score (for both knees) could range from 0 to 100.|5 years post-surgery||||units on a scale||Standard Deviation|Mean
1239350|NCT00589108|Secondary|Knee Society Function Score|The Knee Society Function Score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. The minimum function score is 0.|5 years post surgery||||units on a scale||Standard Deviation|Mean
1239351|NCT00589108|Primary|Maximum Knee Flexion|The range of knee motion was measured clinically with use of a goniometer. Measurements were performed by physician assistants in the Department of Orthopedic Surgery who were blinded to the type of implant used. The subject was positioned supine on the examination table, and maximum active flexion was measured.|2 years post-surgery, 5 years post-surgery||||degrees||Full Range|Mean
1239352|NCT00588965|Secondary|Tpeak-end Interval (Tpe)|Tpeak-end interval was measured at rest, exercise, and recovery on placebo and on propranolol.|Measured after 2 weeks on each intervention||||ms||Standard Deviation|Mean
1239353|NCT00588965|Primary|QTc Response to Exercise on Versus Off Beta-blocker.|To minimize the effect of heart rate on QT, QT was measured at heart rates between 100 and 110 beats per minute during exercise (on and off beta-blocker) and during recovery (on and off beta-blocker).|2 weeks on each treatment then exercise test|Please note that this was a crossover study. There were 35 subjects and each subject completed both the placebo and beta-blocker arm.|||ms||Standard Deviation|Mean
1239354|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|80 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1239355|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|45 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1239356|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|15 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1239357|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|Baseline|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1239358|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|80 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1239359|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|45 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1239360|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|15 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1239361|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|Baseline|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
1239362|NCT00588900|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 2 years|Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.||||||
1239363|NCT00588900|Secondary|Radiographic Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Up to 2 years|Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.||||||
1239364|NCT00588900|Primary|The Percentage of Patients Who Are Progression-free at 12 Weeks From the Start of Second-line Therapy|The 12 week progression-free rate was defined as the percentage of patients that were alive and progression-free 12 weeks after start of second-line therapy. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions.|at 12 weeks||||percentage of participants|||Number
1239365|NCT00588861|Primary|Harris Hip Score|"The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor."|10 Years Post-Operative|This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.||||||
1239366|NCT00588861|Secondary|Harris Hip Score Pain|"Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered None/Ignores. 40 is considered Slight/Occasional. 30 is considered Mild. 20 is considered Moderate. 10 is considered Marked. 0 is considered Totally Disabled."|Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year|This population represents patients that returned for follow-up per protocol.|||Mean Hip Pain||Standard Deviation|Mean
1239367|NCT00588848|Secondary|Cardiopulmonary Complications|Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke|72 hours|None in either group|||Participants|||Count of Participants
1239368|NCT00588848|Secondary|Apnea-Hypopnea Index (AHI)|Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and >= 30 events/hr = severe|On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.|3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep. Study was terminated early due to enrollment problems.|||events per hour||Full Range|Mean
1239369|NCT00588848|Primary|Sleep Related Hypoxemia||On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.|3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep.|||Percentage of time < 90% saturation||Full Range|Mean
1239370|NCT00588822|Secondary|Percentage of Subjects With > 50% Reduction of Monoclonal Protein Titer at 6 Months|Monoclonal immunoglobulins measured included Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM).|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
1239371|NCT00588822|Secondary|Percentage of Subjects Having One or More Stable Hand Grip Strength Ergometry Values for Either Hand at 6 Months|Grip strength was measured by a dynamometer in both hands at baseline and every three months until the final study visit. Response criteria was defined as achieving stable hand grip strength dynamometry values (no more than 10% better or worse relative to baseline at the 6 month visit on either side).|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
1239372|NCT00588822|Secondary|Percentage of Patients Having Improvement in the Hand Grip Strength Ergometry Value for Either Hand at 6 Months|Grip strength was measured by a dynamometer in both hands at baseline and every three months until the final study visit. Response criteria was defined as achieving improvement in hand grip strength dynamometry values (>10% better relative to baseline at the 6 month visit on either side).|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
1239428|NCT00588146|Primary|Change in Hemoglobin|The hemoglobin level is expressed as the amount of hemoglobin in grams (gm) per deciliter (dL) of whole blood.|baseline, one year|Only 3 subjects completed the study, so the numbers were too low to analyze the study.||||||
1239429|NCT00588094|Primary|Improve the Overall Response Rate|assessing the response rate (CR+PR)|2 years||||participants|||Number
1239373|NCT00588822|Secondary|Percentage of Subjects With at Least 1 Grade Improvement in the Modified Rankin Score at 6 Months|The Modified Rankin Scale was used to determine functional disability as follows: 0 = asymptomatic; 1 = symptoms not interfering with manual activities/walking normally; 2 = minor difficulties in manual activities/walking independently without support; 3 = unable to perform some manual activities/walking independently with support; 4 = unable to eat, dress or wash independently/needing assistance to walk; 5 = no useful tasks performed with upper limbs/confined to wheelchair. Therefore, scores could range from 0 to 5, with higher values indicating greater disability.|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
1239374|NCT00588822|Secondary|Percentage of Subjects Whose Disease Has Stabilized or Responded, for Either Side of the Body, as Measured by NIS at 6 Months|"The Neuropathy Impairment Score (previously called the Neurologic Disability Score [NDS]) is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist’s judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100% disability. NIS total score was calculated as the sum of the 35 items, ranging from 0 to 140, with higher score indicating greater disability or impairment.~The NIS score was measured on both sides of the body, the worst score recorded reported as 1 for each individual subject. Stability was defined as change of less than 10 points in the NIS total score. Improvement was defined as at least 10 points improvement in NIS total score, that is, reduction in the number of points on the scale."|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
1239375|NCT00588822|Primary|Percentage of Subjects With at Least 10 Points Improvement in the Neuropathy Impairment Score (NIS) for Either Side of the Body at 6 Months|"The Neuropathy Impairment Score [previously called the Neurologic Disability Score (NDS)] is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist’s judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100% disability. NIS total score was calculated as the sum of the 35 items, ranging from 0 to 140, with higher score indicating greater disability or impairment.~The neurologist measured the NIS score on both sides of the body, but recorded worst score and reported as 1 for each individual subject (i.e., each subject had only 1 reported score.)~Improvement was defined as at least 10 points improvement in NIS total score, that is, reduction in the number of points on the scale."|baseline, 6 months|A dichotomous measure was used so that subjects who discontinued participation prematurely could be included as non-responders.|||percentage of subjects||95% Confidence Interval|Number
1239376|NCT00588809|Secondary|Proportion of Subjects With KIT Mutation|Proportion of subjects with KIT mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.|||percentage of participants|||Number
1239377|NCT00588809|Secondary|Proportion of Subjects With FLT3 ITD Mutation|Proportion of subjects with FLT3 ITD mutation|baseline (0 weeks)|FLT3 ITD mutation status was not available for one patient.|||percentage of participants|||Number
1239378|NCT00588809|Secondary|Proportion of Subjects With KRAS Mutation|Proportion of subjects with KRAS mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.|||percentage of participants|||Number
1239379|NCT00588809|Secondary|Proportion of Subjects With NRAS Mutation|Proportion of Subjects With NRAS Mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.|||percentage of participants|||Number
1239380|NCT00588809|Secondary|Proportion of Subjects With Baseline p-ERK Activation|Proportion of subjects with baseline p-ERK activation|baseline (0 weeks)|The analysis includes the 20 patients with samples available for analysis.|||percentage of participants|||Number
1239381|NCT00588809|Primary|Response Rate for Subjects Without FLT3 ITD Mutation|"Responses were defined using standard criteria developed by an International Working Group.~[Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642–9.]~In this primary outcome, we report the proportion of subjects without FLT3 ITD mutation that experienced a complete response (CR), partial response (PR), minor response (MR), or unconfirmed minor response (uMR)."|Up to 52 weeks|Analysis only includes subjects without FLT3 ITD mutation.|||percentage of participants|||Number
1239382|NCT00588731|Secondary|Overall Cognition as Measured on the MATRICS Battery|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) is intended to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. A higher score indicates better cognition (i.e. speed of processing, attention, verbal and non-verbal working memory, visual learning, reasoning, problem solving, and social cognition). The below scores are t-score values, which are normalized scores to the population and comparing the scores to a representative sample.|6 weeks||||t-score||Standard Deviation|Mean
1239383|NCT00588731|Primary|Verbal Short Term Memory|Verbal short term memory is measured through the Hopkins Verbal Learning Test. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). However, the data listed below is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample, with a mean of 50.|6 weeks||||t-score||Standard Deviation|Mean
1239384|NCT00588692|Secondary|Change in Arterial Elastance|Elastance is a measure of the tendency of a hollow organ to recoil toward its original dimensions upon removal of a distending or compressing force. Effective arterial elastance was determined by the ratio of end systolic BP/stroke volume (SV).|baseline, 6 months||||mmHg/ml||Standard Deviation|Mean
1239427|NCT00588159|Primary|Average Pain Score at Rest|Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.|48 hours|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).|||Units on a scale||Standard Deviation|Mean
1239385|NCT00588692|Secondary|Change in Augmentation Index|"Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.~Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx)."|baseline, 6 months||||percentage of change in AIx||Standard Deviation|Mean
1239386|NCT00588692|Secondary|Change in Central Diastolic BP|Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.|baseline, 6 months||||mmHg||Standard Deviation|Mean
1239387|NCT00588692|Secondary|Change in Central Systolic BP|Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.|baseline, 6 months||||mmHg||Standard Deviation|Mean
1239388|NCT00588692|Secondary|Change in Brachial Diastolic BP|"Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.~There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)~Brachial diastolic BP was determined by a standard oscillometric device (Dinemap, Critikon)."|baseline, 6 months||||mmHg||Standard Deviation|Mean
1239389|NCT00588692|Secondary|Change in Brachial Systolic Blood Pressure (BP)|"Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.~There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)~Brachial systolic BP was determined by a standard oscillometric device (Dinemap, Critikon)."|baseline, 6 months||||mmHg||Standard Deviation|Mean
1239390|NCT00588692|Secondary|Change in Mitral E Wave Deceleration Time|The deceleration time (DT) is the time taken from the maximum E point to baseline. Normally in adults it is less than 220 milliseconds. The DT was measured by pulse wave doppler.|baseline, 6 months||||milliseconds (ms)||Standard Deviation|Mean
1239391|NCT00588692|Secondary|Change in Mitral E/A Ratio|The E/A ratio is a marker of the function of the left ventricle of the heart; it is determined by echocardiography, an ultrasound-based cardiac imaging modality. Abnormalities in the E/A ratio on Doppler echocardiography suggest that the left ventricle, which pumps blood into the circulation, cannot fill with blood properly in the period between contractions. The E/A ratio is the ratio of peak early transmitral inflow velocity and peak late mitral inflow velocity.|baseline, 6 months||||ratio||Standard Deviation|Mean
1239392|NCT00588692|Secondary|Change in Mitral E Velocity|The Mitral E velocity is the speed at which blood fills the ventricle. It is determined by echocardiography, an ultrasound-based cardiac imaging modality.|baseline, 6 months||||cm/sec||Standard Deviation|Mean
1239393|NCT00588692|Secondary|Change in Stroke Volume|Stroke volume (SV) is the volume of blood pumped from one ventricle of the heart with each beat. SV was determined from pulse wave (PW) and continuous wave (CW) Doppler in the LV outflow tract.|baseline, 6 months||||ml||Standard Deviation|Mean
1239394|NCT00588692|Secondary|Change in LV Ejection Fraction|"The ejection fraction is the percentage of the volume in the left ventricle ejected during a cardiac cycle. The normal ejection fraction is 55 to 75 percent. EF = (EDV ‑ ESV) / EDV where EF = ejection fraction, EDV = volume of blood in the left ventricle at end‑diastole, ESV = volume of blood in the left ventricle at end‑systole.~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7)."|baseline, 6 months||||percentage of LV blood volume||Standard Deviation|Mean
1239395|NCT00588692|Secondary|Change in LV End Systolic Volume|"End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle. End systolic volume can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV end systolic volumes was determined from the apical 4 and 2 chamber views using Simpson’s method of discs, along with EF."|baseline, 6 months||||ml||Standard Deviation|Mean
1239396|NCT00588692|Secondary|Change in Left Ventricle (LV) End Diastolic Volume|"End-diastolic volume (EDV) is the volume of blood in the right and/or left ventricle at end load or filling in (diastole). An increase in EDV increases the preload on the heart and, through the Frank-Starling mechanism of the heart, increases the amount of blood ejected from the ventricle during systole (stroke volume).~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV EDV was determined from the apical 4 and 2 chamber views using Simpson's method of discs, along with ejection fraction (EF)."|baseline, 6 months||||ml||Standard Deviation|Mean
1239397|NCT00588692|Secondary|Change in Heart Rate||baseline, six months||||bpm||Standard Deviation|Mean
1239398|NCT00588692|Primary|Change in Aortic Augmentation Index (AIx) According to Ejection Fraction Subgroups|"Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.~Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx)."|baseline, 6 months||||percentage of change in AIx||Standard Deviation|Mean
1239399|NCT00588692|Primary|Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups|Peak oxygen uptake (VO2) is the maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill. Maximal oxygen consumption reflects the aerobic physical fitness of the individual. VO2 data was obtained via standard breath-by-breath expired gas analysis. Ejection Fraction Subgroups are based on participants reported at baseline.|baseline, 6 months|For the EF subgroup 25-49%, n=48, 24 SphygmoCor Unblinded, 24 SphygmoCor Blinded. For the EF subgroup 35-49%, n=33, 14 SphygmoCor Unblinded,. 19 SphygmoCor Blinded. 2 subjects had EF either <25 or >50, and they were not included in the analysis.|||percentage of change in Peak VO2||Standard Deviation|Mean
1239400|NCT00588666|Secondary|The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.||3 years||||percentage of participants|||Number
1239401|NCT00588666|Primary|Evaluate the Time to Disease Progression|Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI, 92(3):205-216, 2000]. Changes in only the largest diameter (uni-dimensional measurement) are used in the RECIST criteria.|3 years||||months||95% Confidence Interval|Median
1239402|NCT00588640|Primary|Number Who Reached a Safe Dose|The number of patients who reached a safe and well tolerated dose of d-methadone|2 years||||participants|||Number
1239403|NCT00588536|Primary|Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX.||Conclusion of the study||||participants|||Number
1239404|NCT00588471|Secondary|Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI|"The EndoPAT is a noninvasive test that involves putting probes on the index fingers of both hands and evaluating the blood flow to one hand before and after inflating a blood pressure cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will now show no blood flow, while the sensor on the opposite index finger will continue to display your normal blood flow level. After several minutes, the blood pressure cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, however, the blood vessels are unhealthy.~The results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart."|baseline, within 24 hours post percutaneous coronary intervention|The study was terminated early because not enough subjects could be recruited.||||||
1239405|NCT00588471|Primary|Change in Serum High Sensitivity C-Reactive Protein (hsCRP)|"The hsCRP test evaluates vascular inflammation. People with higher hsCRP values have the highest risk of cardiovascular disease, and those with lower values have less of a risk. The American Heart Association and U.S. Centers for Disease Control and Prevention have defined risk groups as follows:~Low risk: less than 1.0 mg/L Average risk: 1.0 to 3.0 mg/L High risk: above 3.0 mg/L"|baseline, within 24 hours post percutaneous coronary intervention|The study was terminated early because not enough subjects could be recruited.||||||
1239406|NCT00588445|Secondary|Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data|Each patient provides two binary variables: presence/absence of mutation and responder/non responder. The association between the two will be tested using the Fisher's exact test for the resulting 2x2 table.Changes in expression levels within a patient will be assessed using a paired t-test. Similarly differences in expression levels between responders and non-responders will be assessed using a two-sample t-test. Appropriate adjustment will be made for the multiple comparisons problem that arises because there are over 21,000 probe sets on the U133A array.|2 years||||percentage of participants|||Number
1239407|NCT00588445|Primary|The Radiographic Response to Gefitinib|Radiographic response is defined as a minor response ( > 25% decrease in the sum of the products of measured lesions)|21 days||||participants|||Number
1239408|NCT00588406|Secondary|Hospitalization||6 hours||||percentage of participants|||Number
1239409|NCT00588406|Primary|FEV1 Percent Predicted||4 hours post-randomization||||percent predicted of FEV1||Standard Deviation|Mean
1239410|NCT00588380|Secondary|Insulin Secretion at 210-240 Minutes|The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.|210 - 240 minutes after GLP-1 infusion|All participants completing the study.|||10^-9 min^-1||Standard Error|Mean
1239411|NCT00588380|Primary|Insulin Secretion at 150-180 Minutes.|The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.|150 - 180 minutes after GLP-1 infusion|all participants completed the study|||10^-9 min^-1||Standard Error|Mean
1239412|NCT00588354|Secondary|Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)|The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.|4 weeks||||Units on a scale||Standard Deviation|Mean
1239413|NCT00588354|Secondary|Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)|The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.|2 weeks||||Units on a scale||Standard Deviation|Mean
1239414|NCT00588354|Secondary|Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire|This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.|4 weeks||||Units on a scale||Standard Deviation|Mean
1239415|NCT00588354|Secondary|Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)|This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.|2 weeks|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
1239416|NCT00588354|Secondary|Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire|This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.|4 weeks||||Units on a scale||Standard Deviation|Mean
1239417|NCT00588354|Secondary|Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire|This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.|2 weeks||||Units on a scale||Standard Deviation|Mean
1239418|NCT00588354|Secondary|Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)|11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).|2 weeks|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
1239419|NCT00588354|Primary|Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)|11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).|4 weeks|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
1239420|NCT00588341|Primary|Overall Objective Response (Complete Response or Partial Response)|"The Response Evaluation Criteria in Solid Tumors (RECIST) will be used to determine treatment response.~Clinical Complete Response (CRc) Disappearance of all target lesions and non-measurable disease.~Pathological Complete Response (CRp) A CRc in which a lymph node dissection done after completing temozolomide treatment shows no pathological evidence of melanoma. Partial Response (PR) A greater or equal then 30% in the sum of the longest diameter of all target lesions relative to baseline measurement"|2 years||||participants|||Number
1239421|NCT00588237|Primary|Overall Objective Response|as determined by the GOG RECIST criteria|2 years||||participants|||Number
1239422|NCT00588159|Secondary|Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively|Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively|48 hours postoperatively|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).|||mg||Standard Deviation|Mean
1239423|NCT00588159|Primary|Average Pain Score With Coughing on Second Morning After Surgery|Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.|Second morning after surgery|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy.Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).|||Unites on a scale||Standard Deviation|Mean
1239424|NCT00588159|Primary|Average Pain Score With Coughing the First Morning Following Surgery|Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.|First morning following surgery|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).|||Units on a scale||Standard Deviation|Mean
1239425|NCT00588159|Secondary|Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively|Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.|3 months postoperatively|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Patients who rated their average pain 1 or greater were included.|||Participants|||Number
1239426|NCT00588159|Secondary|Opioid Consumption in First 24 Hours Postoperatively||24 hours|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).|||mg||Standard Deviation|Mean
1239430|NCT00587990|Secondary|Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent Heart Attack||Measured over the 6-month follow-up period and at Month 18 follow-up||||Participants|||Count of Participants
1239431|NCT00587990|Secondary|Minnesota Living With Heart Failure (MLHF) Questionnaire||Measured over the 6-month follow-up period and at Month 18 follow-up|||||||
1239432|NCT00587990|Secondary|New York Heart Association (NYHA) Functional Class||Measured over the 6-month follow-up period and at Month 18 follow-up|||||||
1239433|NCT00587990|Secondary|Peak VO2 (by Treadmill Determination) and 6-minute Walk Test||Measured at baseline and Months 6 and 18 follow-ups|||||||
1239434|NCT00587990|Secondary|Serial Troponin and Creatine Kinase MB (CK-MB) Values||Measured every 12 hours for the first 48 hours after surgery|||||||
1239435|NCT00587990|Secondary|Cardiac Computed Tomography Measures of ISS, Left Ventricular Ejection Fraction, and End Diastolic and End Systolic Volumes||Measured over the 6-month follow-up period and at Month 18 follow-up|||||||
1239436|NCT00587990|Secondary|Pulmonary Function - Forced Expiratory Volume in 1 Second (FEV1) Results||Measured over the 6-month follow-up period and at Month 18 follow-up|||||||
1239437|NCT00587990|Secondary|Hematology, Clinical Chemistry, and Urinalysis Values||Measured over the 6-month follow-up period and at Month 18 follow-up|||||||
1239438|NCT00587990|Secondary|48-hour Ambulatory Electrocardiogram (ECG) Recordings||Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up|||||||
1239439|NCT00587990|Secondary|Treatment Emergent Adverse Event Rates||Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up||||Participants|||Count of Participants
1239440|NCT00587990|Primary|Incidence of Serious Adverse Events (SAEs)|Incidence of serious adverse events (SAEs), defined as the 6-month post-cardiac surgery for coronary artery bypss grafting CABG SAE proportion of patients experiencing sustained ventricular arrhythmias, ectopic tissue formation, or sudden unexpected death|Measured at Month 6 after surgery||||percentage of patients||95% Confidence Interval|Number
1239441|NCT00587964|Primary|Local Control|"following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI.~No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease."|1 year||||participants|||Number
1239442|NCT00587860|Secondary|Bowel Symptom Score (BSS) at 24 Weeks|The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.|24 weeks||||Units on a scale||Full Range|Median
1239443|NCT00587860|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|24 weeks||||Units on a scale||Full Range|Median
1239444|NCT00587860|Secondary|IBS Symptoms Moderately or a Lot Better|Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.|24 weeks||||participants|||Number
1239445|NCT00587860|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|12 weeks||||Units on a scale||Full Range|Median
1239446|NCT00587860|Secondary|Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score|The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.|12 weeks of treatment||||Units on a scale||Full Range|Median
1239447|NCT00587860|Secondary|Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy|"Participants who reported yes or no to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy."|Last 4 weeks of therapy||||Percentage of Participants|||Number
1239448|NCT00587860|Secondary|Bowel Symptom Score (BSS) Amongst Subgroups|Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.|12 weeks|Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.|||Scores on a scale||Full Range|Median
1239449|NCT00587860|Primary|Overall Bowel Symptom Scores (BSS)|"The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks).~The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain."|After 12 weeks of treatment|Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.|||Scores on a scale||Full Range|Median
1239450|NCT00587847|Secondary|Rate of Infections|Number of participants who developed clinical or laboratory evidence of infection.|Weekly then every 2 weeks then every 3 weeks|All participants who received at least one dose of alemtuzumab were analyzed for safety.|||participants|||Number
1239451|NCT00587847|Primary|Time to Progression (Months)|Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.|Every 8 weeks|All patients who were entered on study were analyzed according to NCI Working Group Response Criteria for CLL. Adverse events were graded on a scale of 1 to 4, where possible, according to the NCI Common Toxicity Criteria, Version 2.0.|||months||Full Range|Mean
1239452|NCT00587834|Secondary|Pain Absent After 3 Days (Superiority)|Pain Assessment(Modified Intent-to-Treat Population)|Day 3|||||||
1239453|NCT00587834|Secondary|Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)|The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.|6 months|See description in primary outcome measures. The presence of Coe-Pak (protective periodontal dressing) at Week 1 prohibited the assessment of sensitivity for 14 subjects. The analysis was performed on 71 of the 85 subjects evaluated for efficacy.|||Participants|||Number
1239454|NCT00587834|Secondary|Patient Preference After 6 Months/Early Termination (Superiority)|Number of patients expressing preference for Gintuit.|6 months|See description in primary outcome measure.|||participants||95% Confidence Interval|Number
1239455|NCT00587834|Secondary|Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.|The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.|6 months|See description in primary outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
1239456|NCT00587834|Secondary|Texture Same as Adjacent Tissues After 6 Months (Superiority)|An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as “More Firm”, “Equally Firm”, or “Less Firm” as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.|6 months|See description in primary outcome measures.|||Participants|||Number
1239457|NCT00587834|Secondary|Color Same as Adjacent Tissues After 6 Months (Superiority)|An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as “More Red”, “Equally Red”, or “Less Red” as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.|6 months|See description in primary outcome measure.|||Participants|||Number
1239458|NCT00587834|Primary|Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.|The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.|6 months|Per protocol the first 2 subjects per Investigator were training subjects and evaluated for safety only. There were 11 training subjects and the remaining 85 subjects were analyzed for all efficacy outcomes.|||percentage of participants||95% Confidence Interval|Number
1239459|NCT00587795|Primary|Change in Distal Radius Fracture at 8 Weeks|The investigators planned to make radiographic assessments using the Stewart Score. The Stewart Score can range from 1 to 12, with a higher score indicating poor function: excellent (0), good (1–3), fair (4–6) and poor (7–12).|baseline, 8 weeks|||||||
1239460|NCT00587769|Secondary|Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months|Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations|6 months||||Participants|||Number
1239461|NCT00587769|Primary|Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks|Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations|12 weeks||||Participants|||Number
1239462|NCT00587678|Secondary|V02 - Maximal Oxygen Consumption||2 years||||ml/min/kg||Standard Deviation|Mean
1239463|NCT00587678|Secondary|6-minute Walk Distance||2 years||||ft.||Standard Deviation|Mean
1239464|NCT00587678|Secondary|Log Treadmill Exercise Time||2 years||||log time in seconds||Standard Deviation|Mean
1239465|NCT00587678|Secondary|Magnetic Resonance Angiographic Index|MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.|2 years||||units on scale (0 = normal, 4 = worst)||Standard Deviation|Mean
1239466|NCT00587678|Secondary|Triglycerides||2 years||||mg/dl||Standard Deviation|Mean
1239467|NCT00587678|Secondary|High Density Lipoprotein Cholesterol||2 years||||mg/dl||Standard Deviation|Mean
1239468|NCT00587678|Secondary|Total Cholesterol||2 years||||mg/dl||Standard Deviation|Mean
1239469|NCT00587678|Primary|Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.|Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.|2 years||||seconds||Standard Deviation|Mean
1239470|NCT00587678|Primary|Perfusion Index|Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.|2 years||||Units on a scale (0 = worst, 1 = best)||Standard Deviation|Mean
1239471|NCT00587678|Secondary|Low Density Lipoprotein Cholesterol||2 years||||mg/dl||Standard Deviation|Mean
1239472|NCT00587678|Primary|Plaque Volume|SFA plaque volume|2 years||||cm^3||Standard Deviation|Mean
1239473|NCT00587639|Secondary|Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)|The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60).|At study visit 30||||units on a scale||Standard Deviation|Mean
1239474|NCT00587639|Primary|Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)|The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.|Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)||||units on a scale||Standard Deviation|Mean
1239475|NCT00587587|Secondary|Decreased Utilization of Intralesional Steroid Intervention|The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.|52 weeks|mITT population (randomized subjects only)|||Injections per Participant||Standard Deviation|Mean
1239476|NCT00587587|Secondary|Subject Global Assessment|Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.|||Participants|||Number
1239477|NCT00587587|Secondary|Physician Global Assessment|Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.|||Participants|||Number
1239478|NCT00587587|Secondary|Degree of Recurrence (Scar Thickness)|Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.|Week 52 or Last visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.|||mm||Standard Deviation|Mean
1239479|NCT00587587|Secondary|Degree of Recurrence (Scar Firmness)|Scar firmness measured by Cutometer in millimeters.|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.|||mm||Standard Deviation|Mean
1239480|NCT00587587|Secondary|Cumulative Incidence of Keloid Recurrence at Week 52|Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.|52 weeks|Cumulative assessment, mITT population for randomized subjects only|||participants|||Number
1239481|NCT00587587|Secondary|Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)|"Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.~BSS is a composite score where the individual scores from the following categories are summed:~Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).~Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar)."|Baseline to Week 52 or Last Visit|Modified ITT (mITT) for randomized subjects only. Last Visit is the score recorded at last subject visit with non-missing data.|||Units on a scale||Standard Deviation|Mean
1239482|NCT00587587|Primary|The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.|"Summary of all reported adverse events (AE) in the intent to treat (ITT) population.~AE was defined as any adverse change in the subject’s medical status compared with the subject’s baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject’s pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study."|52 weeks|ITT analysis per protocol. Report of at least 1 treatment emergent AE.|||Participants|||Number
1239483|NCT00587483|Secondary|Time to Discharge From the Hospital||Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.||||Days||Standard Deviation|Mean
1239484|NCT00587483|Secondary|Time to Discharge From the Intensive Care Unit||Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.||||Days||Standard Deviation|Mean
1239485|NCT00587483|Secondary|Use of Vasopressors|Number of participants per arm who required the use of vasopressors in the post-operative period.|Participants were followed from randomization until time to discharge from the hospital.||||Participants|||Number
1239486|NCT00587483|Secondary|Incidence of Arrhythmias in the Post-Operative Period|Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.|Participants were followed from dismissal from the ICU until dismissal from the hospital.||||Participants|||Number
1239487|NCT00587483|Secondary|Incidence of Arrhythmias Other Than Ventricular Fibrillation|Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.|Participants were followed from randomization through the 60 minute period following myocardial reperfusion.||||Participants|||Number
1239488|NCT00587483|Secondary|Number of Defibrillation Attempts||Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|Intention to Treat (IIT)|||Participants|||Number
1239489|NCT00587483|Primary|Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion||Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|Intention to Treat (ITT)|||Participants|||Number
1239490|NCT00587457|Secondary|Percentage Change From Baseline in Cluster of Differentiation 22 (CD22) Expression|Participants demonstrated CD22 expression on malignant cells at Screening and CD22 is a regulatory molecule that prevents the over activation of the immune system and the development of autoimmune diseases.|End of treatment (4-6 weeks after the last dose)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Percentage||Standard Deviation|Mean
1239532|NCT00587158|Secondary|Number of Subjects Who Died or Lost Their Renal Graft During First Year|The number of subject who died (or experienced failure of their kidney surgical graft) during the first year following kidney transplant are reported here.|Baseline to 1 year post kidney transplant|Per-protocol analysis.|||participants|||Number
1239491|NCT00587457|Secondary|Number of Participants With Positive Neutralizing Antibodies|Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.|Up to end of treatment (4-6 weeks after the last dose)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
1239492|NCT00587457|Primary|Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox|The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.|Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3|Safety population included all participants who received any treatment of moxetumomab pasudotox. Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively.|||nanogram per milliliter||Full Range|Median
1239493|NCT00587457|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox|The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.|Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3|Safety population included all participants who received any treatment of moxetumomab pasudotox. Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively.|||hour||Full Range|Median
1239494|NCT00587457|Primary|Best Overall Objective Tumor Response|Antitumor activity was assessed by best overall objective tumor response.|Up to 2 years of post-treatment follow-up|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
1239495|NCT00587457|Primary|Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)|Objective response rate defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria.|Up to 2 years of post-treatment follow-up|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
1239496|NCT00587457|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
1239497|NCT00587457|Primary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)|AEs observed in participants with clinically significant ECG abnormalities were assessed.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
1239498|NCT00587457|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|The vital sign abnormalities which require an action or intervention by the investigator, or a finding judged by the investigator were reported as an adverse event. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
1239499|NCT00587457|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox. Treatment-emergent were events between administration of investigational product and Day 28 that were absent before treatment or that worsened relative to pretreatment state.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
1239500|NCT00587431|Secondary|The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.|Docetaxel Pharmacokinetic parameters for cycles 1 and 2.|at Cycle 1 and 2|A population pharmacokinetic model was fit to the data from all individuals simultaneously using a non-linear mixed effects modeling. This was performed using NONMEM. The NONMEM model accounts for between-patient, between-course, and residual variability (random effects) as well as parameter differences predicted by covariates (fixed effects).|||L/hr||Standard Deviation|Mean
1239501|NCT00587431|Primary|PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy||Conclusion of the study (at 6 months then at 18 months post-treatment)||||participants|||Number
1239545|NCT00587054|Primary|Overall Survival of Transplant Patients|Calculate the median overall survival of transplant patients|up to 6 years||||Days||Full Range|Median
1239546|NCT00587041|Secondary|24 Hour Urine Oxalate Excretion|The amount of oxalate excreted in the urine over a 24 hour period, a risk for calcium oxalate kidney stones|At end of study, approximately 6 weeks|As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.|||mmol/L||Standard Deviation|Mean
1239502|NCT00587288|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation|Participants may have been included in more than 1 category. AEs summarized were those that began or worsened after dispensation of the study drug and before 30 days after the last dose of study drug. If the severity of an AE was missing, the AE was reported as “severe.” If drug relationship of an AE was missing, the AE was reported as “probably related.” WFT=withdrawn from treatment.|From start of study drug through 15 weeks + 30 days|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.|||participants|||Number
1239503|NCT00587288|Secondary|Percentage of Participants With Clinical Asthma Exacerbations (CAEs)|A CAE was defined as a 20% or more decrease in forced expiratory volume in 1 second (FEV1, absolute value) from the baseline value, a requirement for emergency treatment of asthma, hospital admission for asthma, or treatment with 3 or more days of oral corticosteroids for asthma worsening.|up to 15 weeks|ITT Analysis Set: all participants who received any amount of randomly assigned study drug.|||percentage of participants|||Number
1239504|NCT00587288|Secondary|Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels||End of Screening or Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.|||percent change in eosinophil levels||Standard Deviation|Mean
1239505|NCT00587288|Secondary|Change From Baseline to End of Therapy in Percent Predicted FEV1|The change in percent predicted FEV1 from baseline to End of Therapy was calculated from the FEV1 measured during pulmonary function tests using standard spirometry measurements. Each participant’s percent predicted FEV1 was calculated by adjusting the FEV1 for age, sex, height and race. The percent predicted FEV1 was then calculated by comparing the predicted FEV1 to the observed FEV1 using the Crapo formula (Crapo et al 1981a, Crapo and Morris 1981b, Crapo et al 1982).|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.|||percent predicted FEV1||Standard Deviation|Mean
1239506|NCT00587288|Secondary|Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)|The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements.|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.|||L||Standard Deviation|Mean
1239507|NCT00587288|Secondary|Percentage of ACQ Responders at End of Therapy|Responders were defined as participants achieving at least a 0.5 reduction from baseline to End of Therapy in ACQ score. The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug.|||percentage of participants|||Number
1239508|NCT00587288|Primary|Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score|The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.|Baseline through End of Therapy (up to 15 weeks)|Intent-to-treat (ITT) Analysis Set: all participants who received any amount of randomly assigned study drug.|||units on a scale||Standard Deviation|Mean
1239509|NCT00587223|Secondary|Proportion of Wounds Experiencing an Adverse Event||through 12 months|There was only 1 enrolled subject in the study; this endpoint was descriptively reported, no statistical analyses were performed.|||proportion of treated wounds|||Number
1239510|NCT00587223|Secondary|Reduction of Intensity of Pain||through 12 weeks|no analysis performed as only 1 subject enrolled|||change in pain intensity between groups|||Number
1239511|NCT00587223|Secondary|Recurrence of Epidermolysis Bullosa (EB) Lesions||through 12 months|no analysis performed as only 1 subject enrolled|||proportion (%) of treated wounds|||Number
1239512|NCT00587223|Secondary|Rate of Complete Wound Closure Over Time||through 12 weeks|no analysis performed as only 1 subject enrolled|||change in area from baseline to Week 12|||Number
1239513|NCT00587223|Secondary|Time Until Complete Closure||through 12 weeks|no analysis performed as only 1 subject enrolled|||days|||Number
1239514|NCT00587223|Primary|Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12||Through 12 weeks|no analysis performed as only 1 subject enrolled|||proportion (%) of treated wounds|||Number
1239515|NCT00587171|Secondary|Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|Baseline to 17 weeks||||participants|||Number
1239566|NCT00586664|Secondary|Nasal Congestion|Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239516|NCT00587171|Secondary|Distribution of Randot Preschool Stereoacuity at 17 Weeks|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 weeks||||participants|||Number
1239517|NCT00587171|Secondary|Mean (SD) of Change in Intereye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||letters||Standard Deviation|Mean
1239518|NCT00587171|Secondary|Mean (SD) of Intereye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||letters||Standard Deviation|Mean
1239519|NCT00587171|Secondary|Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||letters||Standard Deviation|Mean
1239520|NCT00587171|Secondary|Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||participants|||Number
1239521|NCT00587171|Secondary|Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||letters||Standard Deviation|Mean
1239522|NCT00587171|Secondary|Distribution of Fellow Eye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||participants|||Number
1239523|NCT00587171|Primary|Mean (SD) of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||letters||Standard Deviation|Mean
1239524|NCT00587171|Primary|Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||participants|||Number
1239525|NCT00587171|Primary|Mean (SD): Distance Visual Acuity in Amblyopic Eye at 17-week Outcome|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||letters||Standard Deviation|Mean
1239526|NCT00587171|Primary|Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||participants|||Number
1239527|NCT00587158|Secondary|Degree of Interstitial Fibrosis on Graft Biopsy at One Year|"Interstitial fibrosis refers to degree of scarring or fibrous tissue formed in the kidney. Renal pathologists reviewed biopsies of the subject's kidney grafts for fibrosis, with results expressed using the Banff schema; Quantitative criteria: ci0 = fibrosis observed in up to 5% of cortical area, ci1 = fibrosis in 6%-25% of cortical area (mild) , ci2 = fibrosis in 26%-50% of cortical area (moderate), ci3 = fibrosis in greater than 50% of cortical area (severe). The degree of interstital fibrosis for this study was defined and reported as follows: a Banff ci score of greater than 0 and less than 2 considered mild fibrosis and a ci score greater than or equal to 2 as moderate to severe fibrosis."|1 year post kidney transplant|Per-protocol analysis; graft biopsies were not available for all subjects|||Participants|||Number
1239528|NCT00587158|Secondary|24-hour Total Protein in the Urine at 1 Year Post Transplant|A urine total protein test is conducted to detect excess protein in the urine. This test helps determine an individual's kidney functioning. Protein is not usually present in urine; therefore, presence of protein in the urine is a sign of abnormality. The quantity of protein in a sample of urine collected over 24-hour was measured and reported in milligrams per day.|1 year post kidney transplant|Per-protocol analysis. The 24-hour urine collection was not completed for all subjects.|||mg/day||Standard Deviation|Mean
1239529|NCT00587158|Secondary|Mean Change in Estimated Glomerular Filtration Rate (eGFR) Between 3 Weeks and 1 Year Post Transplant||3 weeks, 1 year post kidney transplant|Per-protocol analysis|||mL/min/1.73 m^2||Standard Deviation|Mean
1239530|NCT00587158|Secondary|Mean Estimated Glomerular Filtration Rate (eGFR) at One Year|Glomerular filtration rate describes the amount that fluid is filtered through the kidney and can be estimated by using serum creatinine. eGFR is reported in milliliters per minute per 1.73 m^2 of body-surface area.|1 year post kidney transplant|Per-protocol analysis|||mL/min/1.73m^2||Standard Deviation|Mean
1239531|NCT00587158|Secondary|Episodes of Acute Cellular Rejection (ACR) of the Renal Transplant|The number of episodes of ACR, as proven by renal biopsy, were recorded.|Baseline to 1 year post kidney transplant|Per-protocol analysis.|||episodes|||Number
1239533|NCT00587158|Secondary|Change in Hip Bone Mineral Density (BMD)|BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements made of the hip bones using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.|Baseline, 1 year post kidney transplant|Per-protocol analysis. Not all subjects were able to undergo the DEXA scan of the hip at baseline and one-year [Control n = 41/Treatment n = 40].|||T-score||Standard Deviation|Mean
1239534|NCT00587158|Secondary|Change in Lumbar Spine Bone Mineral Density (BMD)|BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements of the lower spine made using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.|Baseline, 1 year post kidney transplant|Per-protocol analysis; Not all subjects were able to undergo the DEXA scan of the spine at baseline and one-year [Control n = 42/Treatment n = 41].|||T-score||Standard Deviation|Mean
1239535|NCT00587158|Secondary|Serum Bone Alkaline Phosphatase (BAP) Level Over Time|BAP is a marker of bone turn-over, is measured in the serum and reported in micrograms per liter (mcg/L).|Baseline, 21 days, 90 days and 1 year post kidney transplant|"Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified study visits. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:~Baseline: 43/41, Day 21: 34/38, Day 90: 36/36, Day 365: 43/41"|||mcg/L||Full Range|Median
1239536|NCT00587158|Secondary|Serum Parathyroid Hormone (PTH) Level Over Time|Parathyroid hormone (PTH) is a hormone synthesized in the body's parathyroid glands that controls bone health. PTH controls calcium and phosphorus levels in the body. It is measured in the serum and reported in picograms per milliliter (pg/mL).|Baseline, 3 weeks, 3 months, 1 year post kidney transplant|"Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified timepoints. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:~Baseline: 43/41, Day 21: 44/41, Day 90: 44/43, Day 365: 44/43"|||pg/mL||Full Range|Median
1239537|NCT00587158|Secondary|Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year|Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the lower spine made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the lumbar spine at the end of the first post-transplant year based on bone mineral density results.|1 year post kidney transplant|Per-protocol analysis; Data were not available for 1 subject from each arm because these subjects did not have the one year DEXA scan of the spine. [Control n = 43/Treatment n = 42].|||Participants|||Number
1239538|NCT00587158|Secondary|Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year|Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the hip made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the hip at the end of the first post-transplant year based on bone mineral density results.|1 year post kidney transplant|Per-protocol analysis. Data were not available for 2 control subjects and 2 treatment subjects, as these subjects did not have the DEXA scan of the hip done at one year. [Control n=42/ Treatment=41]|||Participants|||Number
1239539|NCT00587158|Primary|Number of Subjects With Hyperparathyroidism at One Year|Parathyroid hormone (PTH) is a measure of how well the parathyroid gland is working and is measured by a blood test. Hyperparathyroidism (increased PTH) is defined as PTH blood value greater than 65 picograms/milliliter in the absence of hypocalcemia (low calcium) or if the subject had a parathyroidectomy (surgical removal of parathyroid glands) during the first year post-transplant.|1 year post kidney transplant|Analysis was performed by the intention-to-treat principle, comprised of all subjects enrolled, who will have taken at least one dose of study medication and have both screening and any post-screening efficacy data recorded. The last observation was carried forward for missing values.|||Participants|||Number
1239540|NCT00587132|Primary|Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.|Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.|Day 1 of study|All subjects had a normal CT scan. The study was terminated early due to lack of funding. No analysis was done due to the low enrollment.|||participants|||Number
1239541|NCT00587067|Other Pre-specified|Molecular Genetic Changes Associated With These Tumors|Use comparative genomic hybridization and cDNA array from tumor and liver biopsy specimens obtained at the time of operation|5 years||2020-06-30|06/2020||||
1239542|NCT00587067|Secondary|Disease Progression||Up to 5 years||||Participants|||Count of Participants
1239543|NCT00587067|Primary|Number of Patients With Treatment Related Toxicity|Toxicity evaluated and graded according to the National Cancer Institute, CTCAE v4.0|Up to 5 years||||participants|||Number
1239544|NCT00587067|Primary|Treatment Response|To assess the efficacy of continuous arterial infusion (HAI) of FUDR (Floxuridine) and dexamethasone (DEX) in patients with unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).|Up to 5 years||||Participants|||Count of Participants
1239547|NCT00587041|Primary|Change in 24-hour Urinary Supersaturation for Calcium Oxalate|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate. Values for supersaturated ions are expressed in units of Gibbs free energy.|Time zero (on diet but no drug), 6 weeks (on drug and diet)|As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.|||KJoules/mol||Standard Deviation|Mean
1239548|NCT00586898|Primary|Response|Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.|6 months||||participants|||Number
1239549|NCT00586846|Primary|Radiographic Response|to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).|2 years||||participants|||Number
1239550|NCT00586820|Secondary|Percent Change in Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) From Immediately Pre-PCI to 8 and 16 Hours Post-PCI|CK-MB is a cardiac marker that can demonstrate the development of heart muscle necrosis resulting from an acute interruption of blood supply to a part of the heart. CK-MB is measured by a blood test.|immediately pre-PCI, 8 hours post-PCI, 16 hours post-PCI|One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.|||percent change||Inter-Quartile Range|Median
1239551|NCT00586820|Primary|Average Peak Velocity (APV) Immediately Following Percutaneous Coronary Intervention (PCI)|Coronary microvascular blood flow will be assessed following successful PCI by measuring APV in the culprit vessel using Doppler echocardiography.|immediately following PCI procedure|One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.|||cm/s||Inter-Quartile Range|Median
1239552|NCT00586729|Primary|Percentage of Grafted Area That is Viable at Day 14|Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color|14 days|Per protocol|||Percentage area||Standard Deviation|Mean
1239553|NCT00586729|Secondary|Hospital Cost Per Patient|Average hospital irrigant cost per patient|Volume used from admission to discharge|Per protocol|||Dollars||Standard Deviation|Mean
1239554|NCT00586729|Secondary|Length of Stay|Average hospital length of stay in days|0 days, 3 days, 5 days and 14 days post-operation|Per protocol|||Days||Standard Deviation|Mean
1239555|NCT00586716|Secondary|Negative B and T Cell Crossmatch||1year|Study was terminated and no data for the outcome was collected/analyzed because it could not be located.||||||
1239556|NCT00586716|Primary|Elimination of Donor Specific Antibodies||1 year|Study was terminated and no data for the outcome was collected/analyzed because it could not be located.||||||
1239557|NCT00586703|Secondary|Efficacy - Overall Survival|Evaluate the efficacy of the regimen in terms of overall survival (OS).|7 years|Participants who completed infusion.|||months||Full Range|Mean
1239558|NCT00586703|Primary|Toxicity|Evaluate the safety of NK cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplantation from mismatched donors: Toxicity including mortality, occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.|8 weeks|Participants who were able to receive infusion.|||participants|||Number
1239559|NCT00586690|Secondary|Efficacy - Disease Progression|Evaluate efficacy of natural killer (NK) cell infusions in terms of number of patients with disease progression.|3 years|Participants who completed cell infusion.|||participants|||Number
1239560|NCT00586690|Secondary|Efficacy - Overall Survival|Evaluate efficacy of natural killer (NK) cell infusions in terms of overall survival (OS).|8 years|Participants who completed infusion. 9 patients were still alive at the time of this analysis.|||months alive post-infusion||Full Range|Mean
1239561|NCT00586690|Secondary|Efficacy - Progression Free Survival|Evaluate efficacy of natural killer (NK) cell infusions in terms of progression free survival (PFS) in number of months without disease progression.|3 years|Participants who completed cell infusion.|||months||Full Range|Mean
1239562|NCT00586690|Primary|Toxicity|Evaluate the toxicity post-infusion including mortality, occurrence of acute graft versus host disease (GVHD) and other severe toxicity until a minimum of 8 weeks following the last infusion, then at least monthly for 3 additional months. Unacceptable toxicity was defined as grade ≥ III aGVHD of the gut or liver or Grade 4 aGVHD of the skin lasting > 7 days; other Grade 4 toxicity from the procedure in the major organs that lasted > 5 days; or treatment-related mortality (TRM). Though these infusions are provided early following transplantation and severe toxicity could still have occurred due to the primary transplant procedure, for this study any aGVHD or other toxicities occurring after the first day of infusion of the natural killer (NK) cell enriched Donor Lymphocyte Infusions (DLIs) is considered here as study related.|5 months|Participants who completed cell infusion.|||participants|||Number
1239563|NCT00586664|Secondary|Ocular Mucus Discharge|"Percent of Eyes with Ocular Mucus Discharge as measured 7, 15 & 20 minutes post-CAC.~Scored as absent or present"|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Percent of Eyes with OMD Present|||Number
1239564|NCT00586664|Secondary|Tearing|Percent of Eyes with Tearing as measured 7, 15 & 20 minutes post-CAC. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Percent of Eyes with Tearing Present|||Number
1239565|NCT00586664|Secondary|Total Non-Ocular Composite Symptom|Total Non-Ocular Composite Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239592|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||Titer||95% Confidence Interval|Geometric Mean
1239567|NCT00586664|Secondary|Ear or Palate Pruritus (Itchy Ear or Palate)|Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239568|NCT00586664|Secondary|Nasal Pruritus (Itchy Nose)|Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239569|NCT00586664|Secondary|Rhinorrhea (Runny Nose)|Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239570|NCT00586664|Secondary|Eyelid Swelling|Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239571|NCT00586664|Secondary|Chemosis|Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely severe-Overall ballooning of conjunctiva|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239572|NCT00586664|Secondary|Episcleral Redness|Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239573|NCT00586664|Secondary|Ciliary Redness|Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239574|NCT00586664|Primary|Conjunctival Redness|Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239575|NCT00586664|Primary|Ocular Itching|Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1239576|NCT00586625|Primary|Ocular Comfort|"A 4-step grading scale with half unit (1-step) increments allowed:~0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable"|Day 8 & Day 22||||Scores on a scale||Standard Deviation|Mean
1239577|NCT00586612|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14).~Period 2 is defined as the administration of the booster dose until the end of the study (Month 15)."|31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.|||subjects|||Number
1239578|NCT00586612|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after the booster vaccination (month 15)|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.|||subjects|||Number
1239579|NCT00586612|Secondary|Number of Subjects Reporting Solicited Symptoms (Local and General)|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.|During the 4-day follow-up period following booster vaccination|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.|||subjects|||Number
1240132|NCT00581048|Secondary|Effect of Treatment With Vitamin E on Airway Reactivity to Methacholine||At baseline and After 16-18 weeks of treatment with vitamin E|Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 2 for diagram of results||||||
1239580|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||titer||95% Confidence Interval|Geometric Mean
1239581|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|"Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL).~Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component."|Prior to (Month 14) the booster vaccination|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||mIU/mL||95% Confidence Interval|Geometric Mean
1239582|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1239583|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values|"Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.~Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component."|Prior to (Month 14) the booster vaccination|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
1239584|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
1239585|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
1239586|NCT00586612|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL)|Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
1239587|NCT00586612|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL)|Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
1239588|NCT00586612|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the entire primary vaccination phase|Analysis was performed on the Primary Total Vaccinated Cohort.|||subjects|||Number
1239589|NCT00586612|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after each primary vaccination|Analysis was performed on the Primary Total Vaccinated Cohort.|||subjects|||Number
1239590|NCT00586612|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.|During the 4-day follow-up period after any primary vaccination dose|Analysis was performed on the Primary Total Vaccinated Cohort.|||subjects|||Number
1239591|NCT00586612|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.|During the 4-day follow-up period after any primary vaccination dose|Analysis was performed on the Primary Total Vaccinated Cohort.|||subjects|||Number
1240210|NCT00580723|Secondary|Cosmetic Acceptability||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|||||||
1239593|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||Titer||95% Confidence Interval|Geometric Mean
1239594|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||mIU/mL||95% Confidence Interval|Geometric Mean
1239595|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||mIU/mL||95% Confidence Interval|Geometric Mean
1239596|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1239597|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1239598|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239599|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239600|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239601|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239602|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239603|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239604|NCT00586612|Secondary|Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter|Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239605|NCT00586612|Secondary|Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values|Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239606|NCT00586612|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8|rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
1239607|NCT00586612|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)|Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available data.|||subjects|||Number
1239608|NCT00586573|Primary|DSM-IV ADHD Rating Scale (AISRS) Score Change|"AISRS used to assess 18 individual criteria symptoms of ADHD in DSM-IV on a severity grid (0=not present, 3=severe; minimum score=0, maximum score=54). This is a composite score assessing both inattention and hyperactivity, which are not assessed individually in this scale.~Score change from baseline."|Endpoint, following 12 weeks Memantine Monotherapy||||Units on a scale||95% Confidence Interval|Mean
1239609|NCT00586521|Secondary|Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire|Total transformed score with a range of 0-100, higher values indicate better outcome. 41 items in 6 domains: physical functioning; role functioning; worry; consequences; positive affect; treatment concern.|Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)|intent-to-treat-population|||Transformed score||Standard Deviation|Mean
1239610|NCT00586521|Secondary|Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score|Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage|Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)|intent-to-treat|||Gilbert score (0-100)||Standard Deviation|Mean
1239611|NCT00586521|Secondary|Number of All Bleeds|Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)|Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)|intention-to-treat|||All bleeds||Standard Deviation|Mean
1239612|NCT00586521|Primary|Number of Joint Bleeds|Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6|Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)|intent-to-treat population|||Number of joint bleeds||Standard Deviation|Mean
1239613|NCT00586495|Post-Hoc|Number of Participants Who Died|Number of subjects who died due to any cause.|From start of treatment of the first subject until 45 months later, assessed every 3 months|"Overall Survival is shown in Secondary Outcome Measure: Overall Survival."|||participants|||Number
1239614|NCT00586495|Secondary|Overall Disease Control|Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.|||participants|||Number
1239615|NCT00586495|Secondary|Time to Objective Response|Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.|||days||Full Range|Median
1239616|NCT00586495|Secondary|Overall Response Duration|Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.|||days||95% Confidence Interval|Median
1239617|NCT00586495|Secondary|Overall Survival (OS)|Time from initiation of treatment to death due to any cause.|From start of treatment of the first subject until 45 months later, assessed every 3 months|"ITT population. The median overall survival (OS) and the lower limit of 95% Confidence interval were not estimable because more than half (n=51) of the study population were censored. The number of participant who died is shown in Post-Hoc Outcome Measure: Number of Participants who Died."||||||
1239618|NCT00586495|Secondary|Best Tumor Response|Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST)|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population|||participants|||Number
1239619|NCT00586495|Primary|Progression Free Survival (PFS)|Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|Intention to treat (ITT) population.|||days||95% Confidence Interval|Median
1239620|NCT00586482|Other Pre-specified|Self-reported Abstinence From Smoking||Post-operative day 8||||participants|||Number
1239621|NCT00586482|Other Pre-specified|Minnesota Nicotine Withdrawal Score|This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms.|Morning of surgery, pre-operatively||||units on a scale||Standard Deviation|Mean
1239622|NCT00586482|Other Pre-specified|Self-reported Time to Last Cigarette||Morning of surgery, pre-operatively||||Hours||Standard Deviation|Mean
1239623|NCT00586482|Secondary|Self-reported Abstinence|Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.|Morning of surgery, pre-operatively||||participants|||Number
1239624|NCT00586482|Primary|Exhaled Carbon Monoxide Concentration||Morning of surgery, pre-operatively||||Parts per million||Standard Deviation|Mean
1239625|NCT00586469|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Within 21 days after vaccination||||participants|||Number
1239626|NCT00586469|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AE).|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day period following each vaccination.|The analysis was performed on the Total Vaccinated Cohort.|||participants|||Number
1239627|NCT00586469|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face|During the 4-day period following each vaccination.|Analysis was performed on the Total Vaccinated cohort.|||participants|||Number
1239628|NCT00586469|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day follow up period following vaccination.|Analysis was performed on the Total Vaccinated cohort.|||participants|||Number
1239629|NCT00586469|Secondary|The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B|"The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table.~The fold increase corresponds to the Unit of Measure Factor."|At Day 21 compared to Day 0|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||Factor|||Number
1239630|NCT00586469|Secondary|Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1|Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.|At Day 21 compared to Day 0|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||Factor|||Number
1239631|NCT00586469|Secondary|Number of Seroprotected Participants.|The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||participants|||Number
1239632|NCT00586469|Secondary|Number of Participants Who Seroconverted.|The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.|At Day 21.|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||participants|||Number
1239633|NCT00586469|Secondary|Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains|The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)|At Days 0 and 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||Titer||95% Confidence Interval|Geometric Mean
1239634|NCT00586469|Primary|Geometric Mean Titers (GMTs) of Anti-H3 and B Strains|GMTs for H1 strain is addressed as a secondary endpoint|At Day 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||Titer||95% Confidence Interval|Geometric Mean
1239635|NCT00586339|Primary|CMI (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 12|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available at the considered time points.|||Participants|||Count of Participants
1239636|NCT00586339|Primary|CMI (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available at the considered time points.|||Participants|||Count of Participants
1239637|NCT00586339|Primary|CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 2|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available at the considered time points.|||Participants|||Count of Participants
1239638|NCT00586339|Primary|Cell Mediated Immune Response (CMI) (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 0|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available at the considered time points.|||Participants|||Count of Participants
1239639|NCT00586339|Primary|Cell Mediated Immune Response (CMI) (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellullar Cytokine Staining (ICS)|The CMI response is the measure of the cytokines production (i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α) by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining assay. The results were expressed as a frequency of positive CD4 or CD8 T cell producing at least 1 cytokine within the CD4 or CD8 T cell sub-population. All doubles= T cell expressing at least 2 cytokines.|At Months 0, 2, 7 and 12|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Cells||Inter-Quartile Range|Geometric Mean
1239640|NCT00586339|Primary|Concentrations for HPV-16 and HPV-18 Antibodies|"Concentrations were expressed as geometric mean antibody concentrations (GMCs) and were given in EL.U/mL.~The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay were 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18."|At Month 12|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1239699|NCT00586001|Secondary|BIS/BAS Scales (Carver & White, 1994)|The Behavioral Inhibition System/Behavioral Approach System Scales is a 20-item self-report where all items can be rated from 0 to 3. The total score can range from 0 to 60. Higher scores indicate higher levels of behavioral inhibition skills.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239641|NCT00586339|Primary|Concentrations for HPV-16 and HPV-18 Antibodies|"Concentrations were expressed as geometric mean antibody concentrations (GMCs) and were given in EL.U/mL.~The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay were 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18."|At Months 0, 2 and 7|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1239642|NCT00586339|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies|"Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.~A seronegative subject was a subject whose antibody titres are below the cut-off value.~Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus."|At Month 12|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Participants|||Count of Participants
1239643|NCT00586339|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.|"Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.~A seronegative subject was a subject whose antibody titres are below the cut-off value.~Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus."|At Months 2 and 7|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Participants|||Count of Participants
1239644|NCT00586339|Primary|HIV Viral Load at Each Time Point in All HIV+ Subjects|The viral load was calculated by estimating the amount of virus in blood samples and was given in number of Ribonucleic acid (RNA) copies per milliliter.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||RNA copies/mL (in log10)||Inter-Quartile Range|Median
1239645|NCT00586339|Primary|HIV Viral Load at Each Time Point in All HIV+ Subjects|The viral load was calculated by estimating the amount of virus in blood samples and was given in number of Ribonucleic acid (RNA) copies per milliliter.|At pre-vaccination and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||RNA copies/mL (in log10)||Inter-Quartile Range|Median
1239646|NCT00586339|Primary|Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects|The number of CD4+ cells per cubic millimeter at each time point in all HIV+ subjects is reported.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||cells/mm^3||Inter-Quartile Range|Median
1239647|NCT00586339|Primary|Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects|The number of CD4+ cells per cubic millimeter at each time point in all HIV+ subjects is reported.|At pre-vaccination and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||cells/mm^3||Inter-Quartile Range|Median
1239648|NCT00586339|Primary|Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.|CD4+ cell count categories, at baseline, assessed were (i) below 200 CD4+ cells per cubic millimetre (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1 2 = Mild HIV-associated symptoms = WHO clinical stage 2 3 = Advanced HIV-associated symptoms = WHO clinical stage 3 4 = Severe HIV-associated symptoms = WHO clinical stage 4|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239649|NCT00586339|Primary|Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.|"CD4+ cell count categories, at baseline, assessed were (i) below 200 CD4+ cells per cubic millimetre (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3.~WHO classification of HIV-associated clinical disease:~= Asymptomatic HIV-associated symptoms = WHO clinical stage 1~= Mild HIV-associated symptoms = WHO clinical stage 2~= Advanced HIV-associated symptoms = WHO clinical stage 3~= Severe HIV-associated symptoms = WHO clinical stage 4"|At Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239650|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are NEU, PLA, RBC and WBC.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239750|NCT00585468|Primary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||micrograms per milliliter||Standard Deviation|Mean
1239651|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are ALAT, BAS, CREA, EOS, Hct, Hgb, LYM and MON.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239652|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~The parameter presented in this table is alanine aminotransferase (ALAT)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239653|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~Parameters presented in this table are eosinophils (EOS), basophils (BAS) and creatinine (CREA)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239654|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~Parameters presented in this table are lymphocytes (LYM) and monocytes (MON)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239655|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~Parameters presented in this table are white blood cells (WBC) and neutrophils (NEU)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239656|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~Parameters presented in this table are red blood cells (RBC) and platelets (PLA)."|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239657|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are haemoglobin (Hgb) and haematocrit (Hct).|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239658|NCT00586339|Primary|Number of Subjects With Pregnancies and Their Outcome|Pregnancy outcome with live infant having no apparent congenital anomaly.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239659|NCT00586339|Primary|Number of Subjects Reporting Serious Adverse Events|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239751|NCT00585468|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||micrograms per milliliter||Standard Deviation|Mean
1239660|NCT00586339|Primary|Number of Subjects With Medically Significant Conditions|"MSCs were collected regardless of causal relationship to vaccination and intensity.~Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury."|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239661|NCT00586339|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239662|NCT00586339|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|"Medically significant conditions (MSCs) were collected regardless of causal relationship to vaccination and intensity.~Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases.~Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury."|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239663|NCT00586339|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239664|NCT00586339|Primary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms|"Solicited general symptoms assessed were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria.~Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship.~Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination."|Within 7 days (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239665|NCT00586339|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed were pain and swelling. Any = occurrence of any solicited local regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site.~Solicited local symptoms were assessed as related to the study vaccination."|Within 7 days (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1239666|NCT00586326|Secondary|Cosmetic Evaluations Over Time|As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint|At 5 Years|Subjects with Cosmetic Evaluation at 5 Years|||percentage of subjects|||Number
1239667|NCT00586326|Secondary|Disease Free Survival||At 5 Years||||participants||95% Confidence Interval|Number
1239668|NCT00586326|Secondary|Cause Specific Survival||At 5 Years||||participants||95% Confidence Interval|Number
1239669|NCT00586326|Secondary|Overall Survival||At 5 Years||||participants||95% Confidence Interval|Number
1239670|NCT00586326|Primary|Local Control Rate for Follow-up Period of 5 Years.|Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.|Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.||||percentage of subjects|||Number
1239671|NCT00586313|Secondary|The Number of Procedural Complications|Major procedural complications could include: hospitalization, surgery or a radiologic procedure to correct an adverse event; bleeding, infection. Minor procedural complications could be increase in abdominal pain, self-limited hypoxia, bradycardia, tachycardia, hypo or hyper-tension, change in vital signs.|24 months||||complications|||Number
1239672|NCT00586313|Primary|Median Total Specimen Length|Median Total Specimen Length grouped for indication for liver biopsy: Suspected NAFLD, Intrahepatic Cholestasis, Exclusion of Cirrhosis, Increased Liver Function Tests (LFTs) of Uncertain Cause and the Total.|24 months||||mm||Full Range|Median
1239685|NCT00586105|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||months||95% Confidence Interval|Median
1239673|NCT00586261|Primary|Change in Brachial Arterial Reactivity|Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient’s right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.|After 6 months of treatment|The study was stopped early due to low recruitment and no evidence of an effect in this analysis.|||mm||Standard Error|Mean
1239674|NCT00586196|Secondary|Change From Baseline and MDAS Scores Over Time|Measures severity of 10 delirium symptoms items (0 not present, 1 mild, 2 moderate, 3 severe) yielding a total score of 0 to 30, with 30 most severe.|Baseline, hospital discharge, weeks 2, 4 and 6|Based on ability to recruit|||units on a scale||Standard Deviation|Mean
1239675|NCT00586196|Primary|Percentage of Participants With Delirium Using the CAM Over Time|Confusion Assessment Method (CAM)—Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.|Baseline, hospital interviews, weeks 2, 4 and 6||||percentage of participants|||Number
1239676|NCT00586170|Secondary|Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)||24 Weeks|No AOFAS, Foot Function Index, or SF-36 Health Survey data was collected or analyzed.||||||
1239677|NCT00586170|Primary|Percentage of Successful 5th Metatarsal Unions Achieved.|Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.|24 Weeks|Each patient had 1 fracture. The number of fractures treated equals the number of patients treated in both treatment groups.|||percentage of fractures healed|Fractures||Number
1239678|NCT00586157|Primary|Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.|Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).|Baseline and 4 weeks||||Units on a scale||Standard Deviation|Mean
1239679|NCT00586157|Secondary|Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires|"The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian.~Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88"|Baseline and 4 weeks||||Units on a scale||Standard Deviation|Mean
1239680|NCT00586157|Primary|Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.|Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).|Baseline and 4 weeks||||Units on a scale||Standard Deviation|Mean
1239681|NCT00586105|Secondary|Time to Objective Response|Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.|Time from start of study medication to first documented PR or CR up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. Time to objective response was determined on the 5 subjects who had a PR.|||months||Full Range|Median
1239682|NCT00586105|Secondary|Overall Response Duration|Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.|From PR or CR to progression or death up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. The overall response duration was determined on the 5 subjects who had a PR.|||months||Full Range|Median
1239683|NCT00586105|Secondary|Overall Best Response|The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.|Best response observed from start to end of study medication up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||participants|||Number
1239684|NCT00586105|Secondary|Disease Control (DC)|The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).|From start to end of study medication up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||participants|||Number
1239698|NCT00586001|Secondary|Affective Control Scale|The ACS is a 42 item scale where each item is rated from 1 to 7. Scores can range from 42 to 294. Higher scores indicate higher skill levels for controlling emotions|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239686|NCT00586105|Secondary|Overall Survival (OS)|Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.|Time from start of therapy to death up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||months||Full Range|Median
1239687|NCT00586105|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.|Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||months||95% Confidence Interval|Median
1239688|NCT00586105|Primary|Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)|Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by [dose (mg)/weight (kg)].|12 hours after at least 21 days of uninterrupted dosing|A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.|||Kg/L||Standard Deviation|Mean
1239689|NCT00586105|Primary|Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)|Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.|12 hours after at least 21 days of uninterrupted dosing|A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.|||mg/L||Standard Deviation|Mean
1239690|NCT00586105|Primary|Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])|The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose [mg]/weight [kg]).|12 hours after at least 21 days of uninterrupted dosing|A full pharmacokinetics (PK) profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted twice daily (BID) dosing.|||mg*hour/Liter||Standard Deviation|Mean
1239691|NCT00586066|Secondary|Rapid Visual Information Processing Task (RVP)|"RVP is a sensitive measure of sustained attention. In this test, a white box appears in the center of the screen with digits from 2–9 in a pseudorandom order at a rate of 100 digits per minute. Participants are asked to identify target sequences of three digits and to register responses using the press pad.~RVPA is a measure of target sensitivity (i.e., the ability to discriminate between target and distractors). The outcome is defined as a z-score (statistical deviation from normal). A z-score of 0 is average. Higher z-scores represent better than average performance and negative z-scores represent worse than average performance.~RVPB is an index of response bias (i.e., the tendency to respond or not respond in general). The outcome is defined as a z-score (statistical deviation from normal). A z-score of 0 is average. Higher z-scores represent a stronger tendency to respond and negative z-scores represent a less than average tendency to respond."|Weeks 6 and 12|All randomized participants with data available at the given time-point.|||z-score||Standard Deviation|Mean
1239692|NCT00586066|Primary|California Verbal Learning Test (CVLT) at Week 6|The CVLT is used to measure verbal learning and episodic long-term memory. It assesses learning, short- and long-delayed recall and recognition for a list of 16 shopping items. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The reported data represent the number of correct items for the Trial 1, Trial 5, Short Delay Free Recall, and Long Delay Free Recall. The long-delayed recall is assessed at 20 minutes. The CVLT enables a comprehensive characterization of a participant's memory profile.|Week 6|All Randomized participants with data available at Week 6.|||correct items||Standard Deviation|Mean
1239693|NCT00586066|Primary|California Verbal Learning Test (CVLT) at Week 12|The CVLT is used to measure verbal learning and episodic long-term memory. It assesses learning, short- and long-delayed recall and recognition for a list of 16 shopping items. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The reported data represent the number of correct items for the Trial 1, Trial 5, Short Delay Free Recall, and Long Delay Free Recall. The long-delayed recall is assessed at 20 minutes. The CVLT enables a comprehensive characterization of a participant's memory profile.|Week 12|All Randomized participants with data available at Week 12.|||correct items||Standard Deviation|Mean
1239694|NCT00586001|Secondary|The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)|The TMMS is a 48 item self report where each item can be scored from 1 to 5. The three subscales are Attention, Clarity, and Repair. Scores for each of the three subscales can each range from 16 to 80. Higher scores indicate higher emotion regulation skills.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239695|NCT00586001|Secondary|Intolerance of Uncertainty Scale (IUS)|The IUS is a 27-item self report where each item can be scored from 0 to 4. Scores range from 0 to 108. It rates response to uncertainty, ambiguous situations, and the future. Higher scores indicate higher anxiety and depressive symptoms.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239696|NCT00586001|Secondary|The Thought-Action Fusion Scale (Shafran et al., 1996)|The TAF is a 19 item self report where each item can be scored from 0 to 4. Scores can range from 0 to 76. Higher scores indicate a higher frequency of maladaptive cognitive intrusions.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239697|NCT00586001|Secondary|Anxiety Sensitivity Index|The ASI is a 16 item self report where items can be scored from 0 to 4. Scores can range from 0 to 64. Higher scores indicate a higher sensitivity to anxiety and it's symptoms.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1240211|NCT00580723|Secondary|Transepidermal Water Loss (TEWL)||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|||||||
1239700|NCT00586001|Secondary|Emotion Regulation Questionnaire - 2|The ERQ-2 is a 16 item self-report. Items are scored from 1 to 7, and focus on emotional experience and emotional expression. Scores can range from 16 to 112, and higher scores indicate stronger cognitive reappraisal and expressive suppression abilities.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239701|NCT00586001|Secondary|Yale-Brown Obsessive Compulsive Scale|The Y-BOCS is a 12-item scale used to see symptom severity of obsessions and compulsions. Items are scored from 0 to 4. The total score can range from 0 to 48. A higher score indicates higher symptom severity.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239702|NCT00586001|Secondary|Quality of Life Inventory|The QOLI is a 32 item self-report, asking about the importance of 16 domains of life and a participant's satisfaction in each domain. Scores can range from -48 to 115. Higher scores indicate higher quality of life.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239703|NCT00586001|Secondary|Social Interaction Anxiety Scale|The SIAS is a twenty-item measure. Experiences are rated on a 5-point scale from 0 to 4. Experiences are rated on a global period of what is typical. A total score of 60 is possible with cutoffs of 34+ indicative of social phobia and 43+ indicative of social anxiety.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239704|NCT00586001|Secondary|Penn State Worry Questionnaire|The PSWQ is a 16-item questionnaire. Items are rated from 1 to 5, and a total score can range from 16 to 80. Higher scores indicate higher severity of worry symptoms.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239705|NCT00586001|Secondary|Panic Disorder Severity Scale - Self Report Version|Items are rated on a scale of 0 to 4. Scores can range from 0 to 28. Higher scores indicate higher severity of Panic Disorder symptoms|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239706|NCT00586001|Secondary|Work and Social Adjustment Scale|Items are scored on a 0 to 8 scale. The total score range is 0 to 40. Higher scores are more severe. Reported scores are means of total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239707|NCT00586001|Secondary|Beck Anxiety Inventory|Items are scored on a 0 to 3 scale. Total scores range from 0 to 63. 0-9 is minimal, 10-16 is mild, 17-29 is moderate, and 30-63 is severe. Reported scores are a mean of total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239708|NCT00586001|Secondary|Beck Depression Inventory - II|Items are measured on a scale from 0 (little to no symptoms) to 3 (severe). Total scores can range from 0 to 63, higher ratings are more severe. Total score of 0–13 is considered minimal range, 14–19 is mild, 20–28 is moderate, and 29–63 is severe. The reported scores are mean total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239709|NCT00586001|Secondary|Positive and Negative Affect Scale|Positive and Negative Affect Schedule–Negative Affectivity; Positive and Negative Affect Schedule–Positive Affectivity; Items are rated on a scale of 1 (very slightly or not at all) to 5 (extremely) relating to how a person feels average feels the indicated emotion. Total scores can range from 20 to 100. Higher scores are more severe. Reported scores are based on mean totals.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239710|NCT00586001|Secondary|Structured Interview Guide for the Hamilton Depression Rating Scale|Structured Interview Guide for the Hamilton Depression Rating Scale, items are scored on scale of 0 to 4, higher score meaning a higher severity. Total scores can range from 0 (no symptoms) to 53 (severe). Reported scores are a mean of the total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239711|NCT00586001|Secondary|Structured Interview Guide for the Hamilton Anxiety Rating Scale|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Reported scores are the mean total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239712|NCT00586001|Primary|Anxiety Disorders Interview Schedule for DSM-IV|DSM-IV diagnoses of anxiety disorders. Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely disturbing/disabling) passing the clinical threshold for DSM-IV diagnostic criteria.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
1239713|NCT00585975|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses|Day 1||||Participant|||Number
1239714|NCT00585975|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15||||Participant|||Number
1239715|NCT00585923|Secondary|Level of Function (Neck Disability Index)|Number of patients who have an improved, maintained or decreased level of function based on the results of their NDI (Neck Disabillity Index) from surgery to last follow-up visit. The NDI scale ranges from 0-100. If a subject has a score of 0, it means that they have no limitations and no pain. This is calculated by subtracting the NDI at the last follow-up from the NDI at the baseline visit.|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)||||Participants|||Number
1239716|NCT00585923|Secondary|Neurological Status Change in Neurological Status Since Surgery.|Patients were categorized as maintained, improved or decreased Neurological Status. This was assessed pre-operatively and at each follow-up visit but reported on last follow-up. Motor Function was measured at each cervical level Reflex Function (0: Not elicitable; 1: Elicited with reinforcement; 2: Normal; 3:Brisk; 4:Clonus, unsustained; 5: Clonus, sustained) was measured for Bicep, Brachioradialis, and Triceps Sensory Function (0: Sensation is absent; 1: Sensating is diminished; 2: Sensation is normal; 3: Sensation is present, but pathological, was measured at each cervical dermatome|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)||||Participants|||Number
1240212|NCT00580723|Secondary|Skin Photodamage||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|||||||
1239717|NCT00585923|Secondary|Pain With Activity|"Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain with Activity Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Scores range from 0 to 100 with 0 being the best score."|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)||||Participants|||Number
1239718|NCT00585923|Secondary|Pain at Rest|"Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain at Rest Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Best Case is 0 and worst case is 100."|Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)||||Participants|||Number
1239719|NCT00585923|Primary|Fusion Success|"The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views.~Fusion Grading~fused”~probably fused”~pseudarthrosis”~This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused."|Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|Fusion Status is shown for the last office visit which the patient attended before the doctor withdrew from the study|||participants|||Number
1239720|NCT00585910|Secondary|Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders|Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients.|7 weeks||||Units on a Scale||Full Range|Mean
1239721|NCT00585910|Primary|Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)|The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).|7 weeks|All analyses were intent to treat, with last observation carried forward.|||Units on a Scale||Standard Deviation|Mean
1239722|NCT00585715|Primary|Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.|"At the 6 month follow-up, a blinded assessor ranked change in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change.~Using this scale, the average reduction in cellulite appearance was calculated for each participant that experienced a mild to moderate reduction in cellulite appearance."|6 month follow up|The average amount of cellulite reduction was calculated from the 5 subjects who experienced mild to moderate improvement in cellulite appearance.|||units on a scale||Standard Deviation|Mean
1239723|NCT00585715|Primary|Number of Participants With Mild to Moderate Reduction in Cellulite.|"Nurnberger-Muller Scale :~Stage 0: No dimpling. Stage 1: No dimpling. Stage 2: Dimpling spontaneously standing. Stage 3: Dimpling spontaneously standing and lying down.~Texture Scale:~Hard or Solid: Pinch test firm folds and furrows. Adherent to deep planes. Not modified with lying versus standing position.~Soft or Flaccid: Pinch test spongy and floating folds and furrows. No adherence to deep planes. Not painful, flaccid. Orange peel skin appears spontaneously.~Edematous: Doughy consistency. Pain and cramps. Signs of venous and lymphatic insufficiency legs in boot/column.~At the 6month follow-up, a blinded assessor ranked changes in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change. Improvement in cellulite appearance was characterized by an increase of one unit or more on this scale."|6 month follow up|Only subjects who completed the 6 month follow-up were included in the analysis|||participants|||Number
1239724|NCT00585689|Primary|Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment|The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.|63 days (post 3 cycles)|29 patients were enrolled. 26 of the 29 patients received the planned 3 cycles. 22 of the 26 patients had a cystectomy and were evaluable for the primary endpoint.|||percentage of patients||95% Confidence Interval|Number
1239725|NCT00585650|Primary|The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks|Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index (PPPASI) is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4, 4 being the most severe.|Week 12|Intention to treat|||participants|||Number
1239726|NCT00585637|Secondary|Change in CRP From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|||mg/L||Inter-Quartile Range|Median
1239727|NCT00585637|Secondary|Change in sTNF-R2 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|||pg/mL||Inter-Quartile Range|Median
1239728|NCT00585637|Secondary|Change in IL-10 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|||pg/mL||Inter-Quartile Range|Median
1239729|NCT00585637|Secondary|Change in IL-6 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|||pg/mL||Inter-Quartile Range|Median
1239730|NCT00585637|Primary|Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.|Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|Baseline, 3months, 6months|Number of participants analyzed above is for baseline. At 3 months, number of participants analyzed was: 71 (no vitamin D), 67 (1000 IU Vitamin D), 76 (2000 IU Vitamin D) and 78 (4000 IU Vitamin D). At 6 months, number of participants analyzed was: 75 (no vitamin D), 68 (1000 IU Vitamin D), 72 (2000 IU Vitamin D) and 77 (4000 IU Vitamin D).|||ng/mL||Inter-Quartile Range|Median
1239731|NCT00585585|Primary|Maximum Tolerable Dose of Betahistine Dihydrochloride in mg|The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses.|7 weeks|The patient did not complete the study and not enough data were collected to be analyzed.||||||
1239732|NCT00585546|Secondary|Mean Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to 1 Year Following Device Implant|Scale 0 - 105 (0- 5 on 21 items) where 0 means heart failure has not limited daily life at all and high scores mean that daily functions are greatly limited.|1 year|Data is not available for Minnesota Living with Heart Failure Questionnaire at the 12 month time point.||||||
1239733|NCT00585546|Secondary|Absolute Percent Change in Serum Creatinine and Aspartate Transaminase (AST) From Baseline to Week 8 Post Clenbuterol||baseline to week 8 post clenbuterol|baseline data is based on 19 participants, but different subsequent data collections had different numbers of evaluable subjects listed below|||percent change||Standard Deviation|Mean
1239734|NCT00585546|Secondary|Mean Change in Left Ventricular Ejection Fraction From Device Implant to Completion of Clenbuterol Therapy||up to 16 months, variable based on length of time receiveing clenbuterol|data is available for 9 evaluable subjects at end of clenbuterol|||ejection fraction||Standard Deviation|Mean
1239735|NCT00585546|Secondary|Mean Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to 6 Months|Scale 0 - 105 (0- 5 on 21 items) where 0 means heart failure has not limited daily life at all and high scores mean that daily functions are greatly limited.|6 months following LVAD implantation|Only 11 participants provided usable data at the six month time point.|||units on a scale||Standard Deviation|Mean
1239736|NCT00585546|Secondary|Mean Change in EuroQoL Visual Analog Scale (EQ5D-VAS) From Baseline to 6 Months and 1 Year Following Device Implant|Scale 0 - 100 where 0 is worst possible health state and 100 is perfect health.|1 year following LVAD implantation|While baseline data was available for 13 participants at baseline, (start of clenbuterol), different numbers of participants provided evaluable data At six months post implant and 12 months, so the mean changes are based on the actual population that provided both data points as listed below|||units on a scale||Standard Deviation|Mean
1239737|NCT00585546|Secondary|Absolute Percent Change in Serum Creatinine and Aspartate Transaminase (AST) From Baseline to Week 8 Post Implant||Up to 8 weeks after LVAD implantation|Because data only is available for 15 participants for 8 week post implant AST value, it has a different participants analyzed value|||percent change||Standard Deviation|Mean
1239738|NCT00585546|Secondary|Absolute Change in Left Ventricular Ejection Fraction From Explant to 18 Months Following Device Explant||18 months after explantation||||absolute change in ejection fraction|||Number
1239739|NCT00585546|Secondary|Time to Device Explant for Subjects Meeting Explant Criteria Defined in the Protocol|Time from LVAD placement to explant for the single participant who achieved explant|Time to explant (but not to be followed for more than 16 months)||||weeks|||Number
1239740|NCT00585546|Secondary|Number of Subjects Who Received Maximum Target Dose of Clenbuterol||Up to 16 months after LVAD implantation (12 months after beginning clenbuterol)||||Participants|||Count of Participants
1239741|NCT00585546|Secondary|The Number of Evaluable Subjects Meeting Explant Criteria and Subsequently Explanted||Maximum 12 months after LVAD implantation|"Because only 13 began Clenbuterol, only 13 are evaluable for this purpose."|||Participants|||Count of Participants
1239742|NCT00585546|Primary|Percent of Subjects Who Experience LVAD Removal and Subsequent Freedom From Mechanical Circulatory Support or Heart Transplantation for 1-year After Explantation||One year after LVAD explant or until transplant or death (if not explanted)||||percentage of participants|||Number
1239743|NCT00585533|Secondary|Overall Survival|Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.|24 months||||weeks||95% Confidence Interval|Median
1239744|NCT00585533|Primary|Survival Rate at 6-months Chemotherapy-progression-free (CP-free)|Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.|6 months||||percentage of participants|||Number
1239745|NCT00585494|Secondary|Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.||1 year|||||||
1239746|NCT00585494|Secondary|Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.||1 year|||||||
1239747|NCT00585494|Primary|Prevalence of Hyperglycemia in the Elective Orthopedic Population|Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively|1 year||||patients|||Number
1239748|NCT00585468|Primary|Area Under the Curve From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid Glucuronide (MPAG)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)|0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||mcg*h/mL||Standard Deviation|Mean
1239749|NCT00585468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||hours||Full Range|Median
1240213|NCT00580723|Secondary|Skin Tolerance||Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|||||||
1239752|NCT00585468|Primary|Area Under the Curve (AUC) From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid (MPA)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)|0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||mcg*h/mL||Standard Deviation|Mean
1239753|NCT00585468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||hours||Full Range|Median
1239754|NCT00585468|Primary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||micrograms per milliliter||Standard Deviation|Mean
1239755|NCT00585468|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||micrograms per milliliter||Standard Deviation|Mean
1239756|NCT00585377|Secondary|Evaluation of Response Rate|The percentage of patients in which response (CR + PR) was observed: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|2 years||||percentage of participants||95% Confidence Interval|Number
1239757|NCT00585377|Secondary|Evaluation of Progression-free Survival|The length of time during and after bevacizumab-erlotinib that a patient lives with the disease but does not progress according to RECIST 1.0 Criteria. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions|2 years||||weeks||95% Confidence Interval|Median
1239758|NCT00585377|Primary|Evaluation of Overall Survival|The length of time from the start of treatment for a disease that patients are still alive.|2 years|All patients were included in response assessment based on intention to treat including those who received less than 6 weeks of therapy|||weeks||95% Confidence Interval|Median
1239759|NCT00585351|Secondary|Prevention of Chemical Pneumonitis|Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).|Assessed on the day of discharge (average length of stay is approximately 3-7 days)|Intention to treat analysis for secondary outcome (number of participants with aspiration pneumonia).|||Participants|||Number
1239760|NCT00585351|Primary|The Benefit of Advanced Notification in Promoting Informed Consent|Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).|Assessed at time of enrollment into the study.|Intention to treat analysis for primary outcome (number of patients consented).|||Participants|||Number
1239761|NCT00585325|Primary|Pain During Dressing Change|A pain assessment tool performed immediately after the dressing change was used to rate pain experienced during the dressing change. For this tool, pain was rated on a scale from 0-10 (0=no pain and 10=worst possible pain)|During dressing change||||units on a scale|VAC dressing changes|Standard Deviation|Mean
1239762|NCT00585312|Secondary|Colorectal Polyp Burden|"The polyp burden was defined as the sum of the largest diameters of all polyps (>2 mm in size) over Years 1 - 5 cumulatively.~Weighted colorectal polyp burden over Years 1 – 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study."|Years 1 - 5|ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.|||mm||Standard Deviation|Mean
1239763|NCT00585312|Secondary|Total Number of Colorectal Polyps|"Total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5 cumulatively.~Weighted total number of colorectal polyps over Years 1 – 5 cumulatively was defined as the total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study."|Years 1 - 5|ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.|||polyps||Standard Deviation|Mean
1239764|NCT00585312|Secondary|Time to Treatment Failure|"Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:~Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps), or~Diagnosis of colorectal malignancy (ColMal), or~Treatment related dropout (DO). The treatment related dropout was defined as insufficient clinical response, progression of disease, death, adverse event, treatment-related laboratory abnormality, subject no longer willing to participate in study, and other reasons that might be related to treatment as determined by treating physicians in a blind fashion before database release."|5 years|ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Secondary outcome measure was met by 14 (Polyp:7,ColMal:0,DO:14) participants in the Celecoxib and 14 (13,0,12) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.|||years||Standard Deviation|Mean
1239765|NCT00585312|Primary|Time to Disease Progression|"Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:~Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps); or~Diagnosis of colorectal malignancy (ColMal)."|5 years|ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Primary outcome measure was met by 7 (Polyp:7,ColMal:0) participants in the Celecoxib group and 13 (13,0) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.|||years||Standard Deviation|Mean
1239766|NCT00585286|Secondary|Pain Tolerance|"The average pain score reported over all three treatments was 5.67, corresponding to moderate pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being no pain and 10 being worst pain imaginable. All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy."|At treatment visit (up to 3 visits)|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.|||units on a scale||Standard Deviation|Mean
1239767|NCT00585286|Primary|Degree of Atrophy|Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.|||units on a scale||Standard Deviation|Median
1239768|NCT00585286|Primary|Average Improvement in Surface Texture|Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.|||units on a scale||Standard Deviation|Median
1239769|NCT00585286|Primary|Overall Improvement of Acne Scarring|Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.|||units on a scale||Standard Deviation|Mean
1239770|NCT00585247|Primary|Change From Baseline in a* and E at 8 Weeks|Change in a* and ΔE is a way to quantify PWS treatment outcome: a* is the erythema of the vascular lesions and varies from +60 for green to −60 for red with a value of +9.28 for Normal Skin. Higher a* values indicates a greater reduction in erythema hence better treatment outcome. ΔE detects all three dimensions of colorspace (L*a*b*) and represents the difference in color between normal and PWS skin. Range of ΔE is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement.|8 weeks baseline||||units on a scale||Standard Deviation|Mean
1239771|NCT00585221|Primary|Time to Progression (TTP).||two years|||||||
1239772|NCT00585221|Primary|Decrease in Tumor Size.|Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).|18 months|||||||
1239773|NCT00585182|Secondary|Clinically Relevant Bleeding Events|Clinically Relevant Bleeding is defined as fatal bleeding, symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells, or bleeding requiring intervention|Participants were followed for the duration of hospital stay, an average of 5 days||||Events|||Number
1239774|NCT00585182|Primary|Peak Low Molecular Weight Heparin Anti-Xa Activity Level.|The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL|4 - 6 hours after enoxaparin dosing on Day 1 and Day 2||||IU/mL||Standard Deviation|Mean
1239775|NCT00585169|Primary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)|The PGYBOCS is a reliable & valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious.|Baseline to study end point (10 weeks)|All participants who completed at least one study visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
1239776|NCT00585104|Primary|Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.|Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.|From baseline to 30-minutes after levosimendan started.|Ten patients were enrolled. Complete data was available in 6 patients. The primary endpoint was change in left ventricular end diastolic pressure (LVEDP) from baseline to 30-minutes after starting levosimendan. An Intent to Treat (ITT) analysis was performed.|||mmHg||Standard Deviation|Mean
1239777|NCT00585078|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from treatment or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease evaluations occurred every two cycles (42 days ±2 days) on treatment. In this study cohort, participants were followed for progression up to 38 months.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.|||months||95% Confidence Interval|Median
1239778|NCT00585078|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 10.8 months (95% CI: 7.1-37.7) in this study cohort.|The analysis dataset is comprised of treated participants.|||months||95% Confidence Interval|Median
1239812|NCT00584831|Primary|Visual Acuity After Infero-nasal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion||||LogMAR units||Standard Deviation|Mean
1239779|NCT00585078|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.|||participants|||Number
1239780|NCT00585078|Primary|Response Rate|Response rate (RR) is defined as the proportion of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.|||proportion of participants||80% Confidence Interval|Number
1239781|NCT00585052|Secondary|Time to Progression Using the Combination of Lovastatin and Paclitaxel.|To determine the time to progression using the combination of lovastatin and paclitaxel.|Up to one year||||years||Standard Deviation|Mean
1239782|NCT00585052|Primary|Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.|"Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow up. Image based evaluation is preferred to evaluation by clinical examination~Clinical Examination: Clinically detected lesions will only be considered measurable when they are superficial (e.g. skin nodules and palpable lymph nodes.)~Image based evaluation (CT and MRI): Conventional CT and MRI are currently the most reproducible methods of measuring lesions for response assessment."|8 weeks||||Participants|||Count of Participants
1239783|NCT00585039|Secondary|Clinical Asthma Score (CAS)|Change in clinical asthma score while in ED. 15 point clinical asthma score. Score ranges from 5 (no to mild respiratory distress) to a maximum of 15 (severe respiratory distress).|4 hours|analysis per protocol|||units on a scale||95% Confidence Interval|Mean
1239784|NCT00585039|Primary|Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec||Baseline and 4 hours|Enrollment period ended prior to final goal sample size. ITT.|||L/sec||95% Confidence Interval|Mean
1239785|NCT00585013|Secondary|Incidence of Methhemoglobin >5%, Gene Expression Profiles, and S100B.||48 hours|Data not collected for these assessments||||||
1239786|NCT00585013|Primary|Ischemic Injury as Measured by Lactate Levels|Lactate levels correlate to ischemic injury. Higher values represent more injury.|48 hours||||mmol/L||Standard Deviation|Mean
1239787|NCT00585013|Primary|Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels|BNP levels correlate to ventricular and myocardial performance, function, and strain. Higher values represent greater strain and decreased function.|48 hours||||pg/dL||Standard Deviation|Mean
1239788|NCT00585013|Primary|Myocardial Injury|Troponin levels correlate with myocardial injury. Greater troponin levels represent greater myocardial injury|48 hours||||ng/mL||Standard Deviation|Mean
1239789|NCT00585013|Primary|Serum Inflammatory Mediators Post CPB|Inflammation measured through the measurement inflammatory mediators, serum interleukin-6, serum interleukin-8, and tumor necrosis factor. Baseline (preoperative, 0h, 12h, 24h, and 48h.|48 hours||||ng/mL||Standard Deviation|Mean
1239790|NCT00584987|Secondary|Total NPIF|Nasal peak inspiratory flow (NPIF) is a physiological measure of nasal airflow which is particularly sensitive to nasal valve collapse. NPIF was measured objectively in liters per minute with an In-Check Peak Inspiratory FlowMeter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and recorded the best flow measured. The morning and evening NPIF measurements were summed for days 2 through 28 of the treatment cycle, yielding the total NPIF outcome measure. NPIF scores increase with air flow quality (i.e., higher NPIF values are indicative of better nasal air flow).|days 2 through 28 of the treatment cycle||||liters per minute||Full Range|Median
1239791|NCT00584987|Secondary|RQLQ Score [6 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 6 weeks after initiation of treatment regimen||||units on a scale||Standard Error|Mean
1239792|NCT00584987|Secondary|RQLQ Score [4 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 4 weeks after initiation of treatment regimen||||units on a scale||Standard Error|Mean
1239844|NCT00584194|Primary|Safety: All Incidences of Erythema|Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study|12 months||||number of events|||Number
1239793|NCT00584987|Secondary|RQLQ Score [2 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 2 weeks after initiation of treatment regimen||||units on a scale||Standard Error|Mean
1239794|NCT00584987|Secondary|RQLQ Score [Baseline]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed at baseline||||units on a scale||Standard Error|Mean
1239795|NCT00584987|Primary|Total Nasal Congestion Symptom Score|The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).|28 days of treatment||||units on a scale||Full Range|Median
1239796|NCT00584948|Primary|Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale|The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2|1 year||||m/s^2||Standard Deviation|Mean
1239797|NCT00584948|Primary|Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)|The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance.|One Year||||units on a scale||Standard Deviation|Mean
1239798|NCT00584935|Secondary|2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks||24 weeks|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
1239799|NCT00584935|Secondary|1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks||16 weeks|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
1239800|NCT00584935|Primary|2. The Proportion of Patients That Experience a Grade 3, Grade 4, or Grade 5 Toxicity Based Reaction on the NCI-CTC System at the Time of Their Infusions and During Follow-up Visits.||16 weeks|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
1239801|NCT00584935|Primary|Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks|"Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth)~0-25%~25-50%~50-75%~75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by symblepharons and n is the number of symblepharons countable)~a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe"|16 weeks|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
1239802|NCT00584909|Secondary|Toxicity|Toxicity secondary to paclitaxel and carboplatin based upon the NCI common toxicity criteria version|4 years||||participants|||Number
1239803|NCT00584909|Primary|Disease-free Survival|Number of months of survival with no evidence of disease|4 years - Median follow up time of 45.3 months||||months||Full Range|Median
1239804|NCT00584857|Secondary|Toxicity|Toxicity secondary to paclitaxel, carboplatin, and megesterol acetate based on NCI common toxicity criteria|3 years||||participants|||Number
1239805|NCT00584857|Primary|3-year Overall Survival|Number of subjects alive at 3 years|3 years - median followup of 40.4 months||||partipants|||Number
1239806|NCT00584844|Secondary|Immunogenicity: Protocol-compliant Post-boost 2 Titer|"Percentage of subjects with less than or greater than titers who received post-boost 2.~Responder = > 1:20 Non-responder = < 1:20"|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 18 were compliant and analyzed.|||Percentage of subjects|||Number
1239807|NCT00584844|Secondary|Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates|Percentage of subjects with less than or greater than titers (> or < 1:20) who received post-boost 1|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 19 were compliant and analyzed.|||Percentage of subjects|||Number
1239808|NCT00584844|Secondary|Immunogenicity: Protocol Compliant Post-primary Titer Rates|Percentage of subjects with less than or greater than titers (> or < 1:20) for compliant post-primary titers.|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 454 were compliant and analyzed.|||Percentage of subjects|||Number
1239809|NCT00584844|Primary|Safety: Adverse Event Category Rates for All Vaccinations|AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.|AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year||||Adverse events|||Number
1239810|NCT00584831|Primary|Visual Acuity After Superior-nasal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion||||LogMAR units||Standard Deviation|Mean
1239811|NCT00584831|Primary|Visual Acuity After Superior-temporal Version Movement|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion||||LogMAR units||Standard Deviation|Mean
1239938|NCT00583219|Secondary|Postvoid Residual||baseline, 1 month, 3 months||||mL||Inter-Quartile Range|Median
1239813|NCT00584831|Primary|Visual Acuity After Infero-temporal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after insertion||||LogMAR units||Standard Deviation|Mean
1239814|NCT00584740|Primary|Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.|6 weeks|Safety Analysis Set: the safety set included all participants.|||score on a scale||Standard Deviation|Mean
1239815|NCT00584740|Secondary|Percentage of Participants Maintaining Remission|Remission was defined as CDAI < 150 points.|10 weeks|The analysis population included participants of the safety set who achieved remission.|||Percentage of participants|||Number
1239816|NCT00584740|Secondary|Area Under CDAI Curve|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. An area under the CDAI response curve analysis was performed with a starting point from week 4.|10 weeks|Safety Analysis Set: the safety set included all participants.|||Units on a scale*day||Standard Error|Least Squares Mean
1239817|NCT00584740|Secondary|Mean Change From Baseline in CDAI Score|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.|baseline, 2 weeks, 4 weeks|Safety Analysis Set: the safety set included all participants.|||score on a scale||Standard Deviation|Mean
1239818|NCT00584740|Secondary|Percentage of Participants Achieving Response|Response was defined as CDAI reduction of at least 70 points from baseline.|6 weeks|Safety Analysis Set: the safety set included all participants.|||Percentage of participants|||Number
1239819|NCT00584740|Secondary|Percentage of Participants Achieving Remission|Remission was defined as CDAI < 150 points.|6 weeks|Safety Analysis Set: the safety set included all participants.|||Percentage of participants|||Number
1239820|NCT00584740|Secondary|Percentage of Participants Achieving Remission and/or Response|Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.|6 weeks|Safety Analysis Set: the safety set included all participants.|||Percentage of participants|||Number
1239821|NCT00584727|Primary|Patient Preference|This outcome measures which lens the subjects preferred to wear.|end of study|Analysis includes participants who completed the study per protocol (n=88)|||Number of participants|||Number
1239822|NCT00584727|Primary|Patient Reported Comfort.|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88)|||Scores on a scale||Standard Error|Least Squares Mean
1239823|NCT00584727|Primary|Lens Stability Within 5 Degrees|Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.|1 minute|Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)|||degrees|||Number
1239824|NCT00584727|Primary|Lens Orientation Within 5 Degrees|Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.|1 minute|Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)|||degrees|||Number
1239825|NCT00584727|Primary|Patient Reported Vision|A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision.|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88)|||Scores on a scale||Standard Error|Least Squares Mean
1239826|NCT00584727|Primary|Visual Acuity|Number of eyes with Distance Visual Acuity 20/20 or better|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88 subjects,176 eyes)|||Eyes with Snellen VA 20/20 or better|||Number
1239827|NCT00584701|Secondary|Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I|"Affymetrix GeneChip Human Exon 1.0 ST Arrays (Affymetrix, Santa Clara, CA, USA) were used to obtain gene expression values. Raw data (Affymetrix.CEL files) was imported into Partek Genomics Suite 6.4 (Partek, St Louis, MO, USA). Probe summarization and probe set normalization were performed using robust multichip average, which included background correction, quantile normalization, log2 transformation and median polish probe set summarization.~Exons in genes correlated with percentage improvement on the Aberrant Behavior Checklist Irritability subscale were identified."|Baseline, 8 Weeks||||Number of Correlated Genes|||Number
1239939|NCT00583219|Secondary|Mean Number of Pads Per Day||baseline, 1 month, 3 months||||pads per day||Inter-Quartile Range|Mean
1239828|NCT00584701|Primary|Percent Change of ABC - Irritability Subscale Score|"Aberrant Behavior Checklist-Irritability (ABC-I)subscale: measure of assessing changes in symptoms of irritability in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. There are 45 items that are rated on a 4-point scale from “no problem” to “major problem. ABC-I scores ranges from 0 (best) to 45 (worst). A negative change signifies improvement.~We measured percent change of ABC-I scores from 8 weeks after risperidone treatment compared to baseline."|Baseline, 8 weeks||||percent change in scores||Full Range|Mean
1239829|NCT00584558|Secondary|Number of Patients With Complications From Catheter Ablation|Number and % of patients with major adverse events as recorded in the medical record|0-10 years||||Participants|||Count of Participants
1239830|NCT00584558|Primary|Number of Patients With Arrhythmia Recurrence|Number and % patients with documented arrhythmias recurrences|0-10 years|Patients who underwent ablation of arrhythmias|||Participants|||Count of Participants
1239831|NCT00584480|Primary|Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score|Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.|Baseline, 8 Weeks from baseline, and 20 Weeks from baseline||||participants|||Number
1239832|NCT00584454|Primary|The Adverse Reaction and Occupational Illness Endpoint Measurements in This Q Fever NDBR 105 Vaccine Study Will be Evaluated for All Intent-to-treat Volunteers.|Observe adverse reactions and occupational illness endpoint measurements 7 days follow-up after receipt of skin test antigen and 12 months of follow-up after receipt of vaccine|AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study|Subjects at risk of exposure to Coxiella Burnetti (Q Fever)|||Participants|||Count of Participants
1239833|NCT00584415|Secondary|Total Number of Significant Ablation Procedure Related Complications|Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke.|0-1 year||||Complications|||Number
1239834|NCT00584415|Primary|Atrial Tachyarrhythmia Recurrence in Participants|Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.|0-5 years|all patients referred for paroxysmal AF ablation between 1-2004 and 12-2005 were included|||participants|||Number
1239835|NCT00584402|Secondary|Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth|Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type|15 min|Tumor types showed differences in enhancement|||participants|||Number
1239836|NCT00584402|Primary|Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography|After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.|15 min|Tumors were evaluated prior and post contrast injection, 1 tumor per participant|||tumor|tumor||Count of Units
1239837|NCT00584285|Primary|Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns|Comparison of fluorescein patterns of rgp contact lens. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns using standard clinical means.|Baseline first visit||||participants|||Number
1239838|NCT00584220|Primary|Subject Reported Lens Comfort.|A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable.|1 week|Analysis includes only participants who completed the study per protocol and had no missing data.|||Units on a scale||Standard Deviation|Least Squares Mean
1239839|NCT00584220|Primary|Subjective Reported Vision|A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision.|1 week|Analysis includes only participants who completed the study per protocol and had no missing data.|||Units on a scale||Standard Deviation|Least Squares Mean
1239840|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers After 6-month Booster|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.|month 6 after dose 4|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)|||Titers||95% Confidence Interval|Geometric Mean
1239841|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers at 12 Months|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.|at 12 months|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)|||Titers||95% Confidence Interval|Geometric Mean
1239842|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers Before 6-month Booster|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B|Before 6-month booster|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)|||Titers||95% Confidence Interval|Geometric Mean
1239843|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers After 3rd Vaccination|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)|28 days after dose 3|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)|||Titers||95% Confidence Interval|Geometric Mean
1239845|NCT00584077|Secondary|to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year|"Presence of cough as elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis. Lung transplant recipients underwent airway evaluations using the above protocel at 1.5 and 12 months after lung transplantation.~after undergoing transplantation"|15-20 minutes|Stable lung transplant recipients|||Coughs|Coughs|Standard Deviation|Mean
1239846|NCT00584077|Primary|Number of Coughs|The number of coughs elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (D5W) at the level of the main carina, proximal to airway anastomosis (native airway) and distal to the airway anastomosis (allograft airway).|15-20 minutes||||Coughs||Standard Deviation|Mean
1239847|NCT00584012|Primary|Incidence of Dose-limiting Toxicities (DLTs)|To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors.|27 weeks|Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.||||||
1239848|NCT00583947|Secondary|Plasma Concentration of (R,R) Formoterol|If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as <=0.5 picograms/milliliter, the value is displayed as a zero.|predose, various postdose times|PK population consisted of subjects who were in the intent-to-treat population and had any plasma concentration data available.|||picogram/milliliter||Standard Deviation|Mean
1239849|NCT00583947|Secondary|Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)|PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.|||liters/second||Standard Deviation|Mean
1239850|NCT00583947|Secondary|Mean Peak Expiratory Flow Rate (PEFR)|PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.|||liters/second||Standard Deviation|Mean
1239851|NCT00583947|Secondary|Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit.|predose, various postdose timepoints|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses|||liters||Standard Deviation|Mean
1239852|NCT00583947|Primary|Change From Predose in Mean Serum Glucose|Change in mean serum glucose at the specified timepoint minus the predose value.|predose, 2 and 6 hours post dose|Intent to treat population|||mg/dl||Standard Deviation|Mean
1239853|NCT00583947|Primary|Mean Serum Glucose Values||Predose, 2 and 6 hours post dose 1|Intent to treat population|||mg/dl||Standard Deviation|Mean
1239854|NCT00583947|Primary|Change From Predose in Mean Serum Potassium|Change in mean serum potassium at the specified timepoint minus the predose value.|predose, 2 and 6 hours post dose|Intent to treat population|||mEq/L||Standard Deviation|Mean
1239855|NCT00583947|Primary|Mean Serum Potassium Levels||Predose, 2 hours and 6 hours postdose 1|Intent to treat population|||mEq/L||Standard Deviation|Mean
1239856|NCT00583947|Primary|Change From Predose in Mean Diastolic Blood Pressure|Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||mmHg||Standard Deviation|Mean
1239857|NCT00583947|Primary|Mean Diastolic Blood Pressure|Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||mmHg||Standard Deviation|Mean
1239858|NCT00583947|Primary|Change From Predose in Mean Systolic Blood Pressure|Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||mmHg||Standard Deviation|Mean
1239859|NCT00583947|Primary|Mean Systolic Blood Pressure|Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||mmHg||Standard Deviation|Mean
1239860|NCT00583947|Primary|Change From Predose in Mean Heart Rate|Heart rate measured at various timepoints minus the heart rate at predose.|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||beats per minute||Standard Deviation|Mean
1239861|NCT00583947|Secondary|Mean Forced Expiratory Volume in One Second(FEV1)|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.|||liters||Standard Deviation|Mean
1239862|NCT00583947|Primary|Mean Heart Rate|Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||beats per minute||Standard Deviation|Mean
1239863|NCT00583908|Secondary|Degree of Lens Rotation in Inferior Gaze.|Degree of lens rotation while participant is gazing down.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.|||Degree of rotation||Standard Deviation|Mean
1239864|NCT00583908|Secondary|Degree of Lens Rotation in Inferior-nasal Gaze.|Degree of lens rotation while participant is gazing down and in.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.|||Degree of rotation||Standard Deviation|Mean
1239865|NCT00583908|Secondary|Degree of Lens Rotation Inferior-temporal Gaze.|Degree of lens rotation while participant is gazing down and out.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.|||Degree of rotation||Standard Deviation|Mean
1239866|NCT00583908|Secondary|Degree of Lens Rotation in Nasal Gaze.|Degree of lens rotation while participant is gazing in(towards the nose).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
1239867|NCT00583908|Secondary|Degree of Lens Rotation in Temporal Gaze.|Degree of lens rotation while participant is gazing out(towards the temple).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
1239868|NCT00583908|Secondary|Degree of Lens Rotation in Superior-nasal Gaze.|Degree of lens rotation while participant is gazing up and in(towards the nose).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
1239869|NCT00583908|Secondary|Degree of Lens Rotation in Superior-temporal Gaze.|Degree of lens rotation while participant is gazing up and out(towards the temple).|After each of 4 lens insertions.,|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
1239870|NCT00583908|Secondary|Degree of Lens Rotation in Superior Gaze.|Degree of lens rotation while participant is gazing up.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
1239871|NCT00583908|Primary|Visual Acuity During Head Tilt|"logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity.~logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal."|after each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.|||logMAR units||Standard Deviation|Mean
1239872|NCT00583908|Primary|Lens Orientation During Head Tilt.|Degree of lens rotation on the eye with the head tilted.|after fit of each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
1239873|NCT00583804|Secondary|Adverse Events|Self-reported adverse events.|From date of implant until study completion or date of death from any cause.|||||||
1239874|NCT00583804|Primary|Activities of Daily Living Test|Evaluation of independence and performance for at least six activities of daily living, including eating with a fork, drinking from a cup, etc.|Three months||||Number of Tasks Improved||Full Range|Median
1239875|NCT00583804|Primary|Grasp-Release Test|Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.|One Year||||Number of Objects||Full Range|Median
1239876|NCT00583713|Primary|Elimination Rate Constant||1 day||||1/hr||Standard Deviation|Mean
1239877|NCT00583713|Primary|Area Under the Curve for the 24-hour Dosing Interval||1 day||||µmol*hr/L||Standard Deviation|Mean
1239878|NCT00583713|Primary|Terminal Half-life||1 day||||hours||Standard Deviation|Mean
1239879|NCT00583713|Primary|Time to Maximum Concentration||1 day||||hours||Standard Deviation|Mean
1239880|NCT00583713|Secondary|Urinary Sulfate Concentration||pre-dose to 6 days post-dose||||mg/dL||Standard Deviation|Mean
1239881|NCT00583713|Primary|Maximum Observed Concentration (Cmax)||1 day||||µmol/L||Standard Deviation|Mean
1239882|NCT00583700|Secondary|Tissue Compliance|"Tissue compliance meter measurements of the treated breast compared to the non-treated breast were obtained at 18 months post-radiation therapy. Tissue compliance simply means how soft and pliable the breast tissue is when force is applied to it.~One physician would hold the tissue compliance meter (TCM) against the participant's skin. A standard amount of force would be applied. A second physician would read the displacement scale for a specific set of areas on the breast. The range of the scale was 0 to 60 milimeters (mm). The physician's were blineded to the participant's intervention at the time of measurement.~The final value is the difference between the untreated and the treated breast [untreated - treated]. The range of these differences was -3.3 to 7.0 mm."|18 months post-treatment|All study participants enrolled were to be measured at 18 months post-radiotherapy. The number of participants analyzed varied by the number compliant with study schedule.|||milimeters (mm)||Standard Deviation|Mean
1240282|NCT00579670|Post-Hoc|"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1239883|NCT00583700|Primary|Subjective, Objective, Management, and Analytic (SOMA) Score|A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.|18 month post-treatment|All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments.|||units on a scale||Standard Deviation|Mean
1239884|NCT00583661|Primary|Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device.|Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.|Participants were followed while on device support, an average of 58 days|All subjects implanted with the device were included in this analysis.|||participants|||Number
1239885|NCT00583661|Primary|The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device.|The serious adverse event rate was calculated by totaling the number of serious adverse events all subjects experienced during device support (from implant to explant, an average of 58 days) divided by the total support time (in days) for all subjects. The serious adverse event rates were calculated separately for each primary study cohort.|Participants were followed while on device support, an average of 58 days|All 48 participants were included in the analysis. Adverse Events for each participant was counted and the total number of events was divided by the total time the Cohort's subjects were supported on device. A 95% Poisson confidence interval was calculated around the point estimates.|||Events per patient-day||95% Confidence Interval|Number
1239886|NCT00583622|Secondary|Participant Response|Number of participants evaluated using Response to Treatment in Solid Tumors (RECIST) with definitions of Complete Response (CR): disappearance of all target lesions; and, Partial Response: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Maintained Continued CR: participants who entered study in a CR and maintained CR post study treatment. Evaluations once a week till Day +30, then Days 30, 60, and 100 then at 6 months or until disease progression.|Up to 6 months|One participant was not evaluable for response as participant expired prior to performing restaging evaluation.|||percentage of participants|||Number
1239887|NCT00583622|Primary|Event-Free (EF) Rate|Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.|Up to 6 Months|Due to the small number of patients treated, 12 out of 30 planned, an analysis was not possible.||||||
1239888|NCT00583596|Primary|Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure|The number of participants with a residual shunt (efficacy)|Long term follow up data captured at 5, 6 or 7 years post implant|Of the 152 subjects that completed long term follow-up, 128 subjects underwent Transthoracic echocardiogram (TTE) at their final visit.|||participants|||Number
1239889|NCT00583596|Primary|Reporting of Late Adverse Events Relating to the Device.||Long term follow up for data captured at 5, 6 or 7 years post implant|152 subjects of the 436 subjects eligible for post market survelliance completed a 5, 6 or 7 year follow-up.|||participant|||Number
1239890|NCT00583557|Secondary|The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).|NOT ANALYZED|up to 5 Years|||||||
1239891|NCT00583557|Primary|To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.|SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.|Up to 5 years||||Particpants|||Number
1239892|NCT00583492|Secondary|Decrease in Quality of Life|Quality of Life was measured using the comprehensive Expanded Prostate Cancer Index Composite (EPIC) instrument 19 and 20|3 years||||participants|||Number
1239893|NCT00583492|Secondary|Disease-specific Survival||10 years||||participants|||Number
1239894|NCT00583492|Secondary|Freedom From Distant Metastases||10 years||||participants|||Number
1239895|NCT00583492|Secondary|Positive Prostate Biopsy at 2 Years||2 years||||participants|||Number
1239896|NCT00583492|Secondary|Acute >= Grade 3 Treatment-related Toxicity|This metric includes both expected and unexpected events Toxicities were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3|90 days||||percentage of adverse events|||Number
1239897|NCT00583492|Primary|Freedom From Biochemical/Clinical Failure (FFF)|Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL|5 years||||participants|||Number
1239898|NCT00583466|Primary|Duration of the Submucosal Cushion||Immediately after the procedure, Up to 5 minutes|No data is available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published.||||||
1239899|NCT00583453|Secondary|Total Morphine Equivalent|Participant reported mophine equivalent use|From operative day through 10 days post-operative||||mg||Standard Error|Mean
1239900|NCT00583453|Secondary|Incidence of Post-operative Hemorrhage|The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.|From operative day through 10 days post-operative||||Participants|||Count of Participants
1239901|NCT00583453|Secondary|Acetaminophen Equivalent Use|Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.|From operative day through 10 days post-operative||||mg||Standard Error|Mean
1239902|NCT00583453|Secondary|Self-reported Activity Level|Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.|From operative day through 10 days post-operative||||Activity score (units on a scale)||Standard Error|Mean
1239903|NCT00583453|Primary|Self-reported Pain Score|Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.|day of procedure through post-operative day 10||||pain score (units on a scale)||Standard Error|Mean
1239998|NCT00582517|Primary|Knee Stability|The hypothesis of this study was that there would be equivalent final knee range of motion with fewer failures for ligament reconstructions following knee dislocations that were supplemented with the Compass Knee Hinge as compared to a control group.|12 months||||participants|||Number
1239904|NCT00583375|Secondary|SF-12 Physical Component Score|"The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life.~Maintenance or improvement: ≥0 point increase from baseline~Slight Decline: 0-10 point decrease from baseline~Deteriorated: >10 point decrease from baseline"|24 and 52 weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
1239905|NCT00583375|Secondary|AOFAS Hindfoot and Ankle Score|"Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.~Clinically significant improvement: ≥20 point increase from baseline~Improved: 10-20 point increase from baseline~Maintained: <10 point increase from baseline and <10 point decrease from baseline~Deteriorated: >10 point decrease from baseline"|24 and 52 weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
1239906|NCT00583375|Secondary|Foot Function Index (FFI)|"The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.~Clinically significant improvement: ≥10 point decrease from baseline~Improved: 5-10 point decrease from baseline~Maintained: <5 point decrease from baseline and <5 point increase from baseline~Deteriorated: >5 point increase from baseline"|24 and 52 weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
1239907|NCT00583375|Secondary|Pain at Fusion Site|"Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).~Clinically significant improvement: ≥20mm decrease from baseline~Detectable improvement: 10-20mm decrease from baseline~Maintained: <10mm decrease from baseline and <10mm increase from baseline~Deteriorated: >10mm increase from baseline"|24 and 52 weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
1239908|NCT00583375|Secondary|Pain on Weight Bearing|"Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).~Clinically significant improvement: ≥20mm decrease from baseline~Detectable improvement: 10-20mm decrease from baseline~Maintained: <10mm decrease from baseline and <10mm increase from baseline~Deteriorated: >10mm increase from baseline"|24 and 52 Weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
1239909|NCT00583375|Primary|Subjects Fused at 24 Weeks (as Determined by CT Assessment)|An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused.|24 weeks|The mITT population consisted of 397 patients (414 patients in the Safety group minus 17 subjects excluded post-operatively).|||Participants|||Count of Participants
1239910|NCT00583362|Secondary|Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points|Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percent change||Full Range|Median
1239911|NCT00583362|Secondary|Absolute Serum Immunoglobulin G Values at Indicated Time Points|Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||grams per liter||Full Range|Median
1239912|NCT00583362|Secondary|Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points|Daily prednisone dose reduction was assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percentage of participants|||Number
1239940|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at 3 Months|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|3 months after treatment||||participants (per category)|||Number
1239913|NCT00583362|Secondary|Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points|Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percent change||Full Range|Median
1239914|NCT00583362|Secondary|Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points|Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.|||grams per liter||Full Range|Median
1239915|NCT00583362|Secondary|Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points|Anti-double stranded DNA levels for participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percent change||Full Range|Median
1239916|NCT00583362|Secondary|Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points|Anti-double stranded DNA levels in participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.|||International units (IU)/milliliter (mL)||Full Range|Median
1239917|NCT00583362|Secondary|Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points|SRI response was assessed at Week 16, 32, and 48 during Year 1 to 12 and Week 16 and 32 during Year 13. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. SRI response is defined as:>=4 point reduction from the Baseline in safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the Baseline) in Physician's Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the Baseline at the time of assessment.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percentage of participants|||Number
1239918|NCT00583362|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||International units per liter||Standard Deviation|Mean
1239919|NCT00583362|Primary|Change From Baseline in BUN/Creatinine at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Ratio||Standard Deviation|Mean
1239920|NCT00583362|Primary|Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||micromoles per liter||Standard Deviation|Mean
1239921|NCT00583362|Primary|Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||millimoles per liter||Standard Deviation|Mean
1239922|NCT00583362|Primary|Change From Baseline in Albumin and Protein at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||grams/liter||Standard Deviation|Mean
1239923|NCT00583362|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||grams per liter||Standard Deviation|Mean
1239924|NCT00583362|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percentage of blood by volume||Standard Deviation|Mean
1239925|NCT00583362|Primary|Change From Baseline in Erythrocytes at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||10^12 per liter||Standard Deviation|Mean
1239926|NCT00583362|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||10^9 per liter||Standard Deviation|Mean
1239941|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at 1 Month|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|1 month after treatment||||participants (per category)|||Number
1240028|NCT00582166|Secondary|Overall Survival (OS)|To estimate overall survival, 95% confidence intervals will be used.|At 12 months||||percentage of participants||95% Confidence Interval|Median
1239927|NCT00583362|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Seconds||Standard Deviation|Mean
1239928|NCT00583362|Primary|SAE Rates by System Organ Class (SOC) During the Study|SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).|Approximately up to 13 years|MITT population|||Events per 100 participant years|||Number
1239929|NCT00583362|Primary|Adverse Event (AE) Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).|Approximately up to 13 years|MITT Population|||Events per 100 participant years|||Number
1239930|NCT00583362|Primary|Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)|An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example [eg], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.|||Participants|||Number
1239931|NCT00583219|Secondary|Incontinence Impact Questionnaire-short Form (IIQ-7) Scores|The IIQ-7 was one measure of urinary-associated quality of life. The IIQ-7 questionnaire has 7 items, scored from 0 (not at all) to 3 (greatly), with total scores ranging from 0 to 21, a higher score indicating greater distress.|baseline, 1 month, 3 months||||units on a scale||Inter-Quartile Range|Median
1239932|NCT00583219|Secondary|Bothersomeness|The bothersomeness refers to the question: On a scale of 1-10 (0 is not at all; 10 is intolerable), how badly does loss of urinary control bother you?|baseline, 1 month, 3 months||||units on a scale||Inter-Quartile Range|Median
1239933|NCT00583219|Secondary|Median Urogenital Distress Inventory (UDI-6) Scores|The UDI-6 was one measure of urinary-associated quality of life. The UDI-6 questionnaire has 6 items, scored from 0 (not at all) to 3 (greatly), with total scores ranging from 0 to 18, a higher score indicating greater distress.|baseline, 1 month, 3 months||||units on a scale||Inter-Quartile Range|Median
1239934|NCT00583219|Secondary|Urinary Urgency at 3 Months|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|3 months after treatment||||participants (per category)|||Number
1239935|NCT00583219|Secondary|Urinary Urgency at 1 Month|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|1 month after treatment||||participants (per category)|||Number
1239936|NCT00583219|Secondary|Urinary Urgency at Baseline|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|baseline||||participants (per category)|||Number
1239937|NCT00583219|Secondary|Urine Culture||baseline, 1 month, 3 months||||participants|||Number
1239942|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at Baseline|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|baseline||||participants (per category)|||Number
1239943|NCT00583219|Secondary|Median 24 Hour Pad Weight|Prior to baseline and follow-up visits, the study coordinator weighed standard pads provided to the subject for the study time period. The study coordinator instructed the subject to bring in any pads used during the 24-hour period prior to baseline and follow up visits. The study coordinator recorded the 24-hour pad weights into the study dataset.|baseline, 1 month, 3 months||||g||Inter-Quartile Range|Median
1239944|NCT00583219|Primary|Median Number of Incontinent Episodes During 24 Hours|The study coordinator instructed the subject to keep record of any incontinence episodes during the 24-hour period prior to their baseline and follow-up visits.|baseline, 1 month, 3 months||||number of incontinent episodes||Inter-Quartile Range|Median
1239945|NCT00583115|Secondary|1) Decrease in Pulmonary Artery Pressures and Vascular Resistance as Determined by Cardiac Catheterization, 2) Time to Clinical Worsening,3) Survival.||6 months|The only participant died prior to study completion. Unable to measure pulmonary artery pressure and vascular resistance as only participant died prior to study completion. Unable to measure time to clinical worsening as only participant died. Survival should be counted as 0.||||||
1239946|NCT00583115|Primary|1) Safety and Tolerability as Determined by Laboratory Evaluation, Physical Examination, Echocardiographic Analysis, and Adverse Events, and 2) Efficacy as Determined by an Increase in the Non-encouraged 6 Minute Walk Test From Baseline.||6 months|Unable to measure safety and tolerability as the participant died prior to study completion. Laboratory evaluations not able to be measured as participant died. Physical examination, Echocardiographic and adverse events not able to be measured as participant died Unable to measure 6 minute walk test as participant died prior to study completion.||||||
1239947|NCT00583102|Primary|Complete Remission Rate|"The primary study end point will be complete remission rate.~Complete Remission (CR):~Complete remission is defined as the presence of all of the following:~Peripheral Blood Counts (sustained > 30 days)~Absolute neutrophil count ³1500/ml.~Platelet count ³100,000/ml.~No leukemic blasts in the peripheral blood.~Transfusion independent for red cells and platelets. Bone Marrow~Cellularity >20% with maturation of all cell lines.~No Auer rods.~<5% blast cells. No extramedullary leukemia (such as CNS or soft tissue involvement). OR Complete Response with Incomplete Platelet Recovery (CRp): CRp satisfies all CR criteria except platelets < 100,000/µL.~Partial Remission (PR):~Must meet all criteria of a CR except that the bone marrow may contain 5-24% blasts.~Treatment Failure:~Failure to achieve a CR."|5 weeks|7 patients out of the 20 who completed the trial were primary refractory AML, so as per protocol these patients were not included for assessment and the early stopping rule.|||Participants|||Count of Participants
1239948|NCT00582972|Secondary|Change in Bone Resorption From Baseline to 1 Month|urine n-telopeptide (normalized to creatinine levels)|change in bone resorption from baseline to 1 month|23 enrolled but two dropped from the study, leading to 21 subjects who completed all study visits|||mcg/mmol creatinine||Standard Deviation|Mean
1239949|NCT00582972|Primary|Change in Intestinal Calcium Absorption From Baseline to One Month|percent calcium absorption|change in calcium absorption from baseline to 1 month|Subjects completing the measures of calcium absorption were included in the analysis of the primary outcome.|||percent calcium absorption||Standard Deviation|Mean
1239950|NCT00582946|Primary|Maximum Effective Sound Pressure Level (MEPO)|A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.|1 month||||decibels (dB) Sound Pressure Level (SPL)||Standard Deviation|Mean
1239951|NCT00582933|Primary|Death From GVHD|To establish the early transplant-related severe morbidity and mortality and 3-the incidence and severity of GvHD.|2 years||||participants|||Number
1239952|NCT00582907|Secondary|To Determine the Differences in the Proportion of Time Subjects Received Rilonacept vs Placebo|"The proportion of time within the trial that participants received rilonacept as opposed to placebo. The reason for this outcome is that participants who had at least 2 attacks within an individual treatment course were able to escape in a blinded manner to the other treatment arm until the end of that treatment course and then resume the original randomization sequence. Thus participants may have been treated for a longer time with one treatment arm or the other."|12 months|Participants who received at least one treatment course of both rilonacept and placebo.|||Percentage of time treated||95% Confidence Interval|Number
1239953|NCT00582907|Secondary|To Determine the Differences in the FMF Severity Score of the Subjects Between the Treatment Arms (Rilonacept vs. Placebo).|Differences in the Armenian Evaluation Score between rilonacept and placebo courses. The Armenian Evaluation Score is a composite score of disease severity based on the frequency, duration and character of attacks (degree of fever and severity of serositis). It was adapted to calculate a score for a 3-month treatment course. The lowest (best) score is 0 and higher values are worse. In theory there is no upper limit to the scale. The total score is reported (there are no subscales).|overall 12 months|Participants who received at least one course each of placebo and rilonacept.|||units on a scale||Inter-Quartile Range|Median
1239971|NCT00582816|Secondary|Association Between Parental KIR Genotypes and NK Cell Cytotoxicities|NK cells express killer-cell immunoglobulin-like receptors (KIR) and have cytotoxic activity. The association between NK cell cytotoxicity over time and KIR genotypes will be examined. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Day 60|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.||||||
1239954|NCT00582907|Secondary|To Determine the Differences in the Quality of Life Between the Treatment Arms (Rilonacept vs. Placebo).|Differences in the health-related quality of life (HRQOL) during treatment with rilonacept vs. placebo. HRQOl was measured by the Childhood Health Questionnaire which was adopted also for adults. There are 2 summary scores: 1. Physical summary score. 2. Psychosocial summary score. The data reported below in the upper table is the physical summary composite score and in the lower table the psychosocial summary composite score. Scores were from 0-100 (higher is better) with a score of 50 representing the mean of the normal population.|12 months|Participants who received at least one treatment course of rilonacept and placebo.|||Composite HRQOL summary score||Inter-Quartile Range|Median
1239955|NCT00582907|Secondary|To Determine the Differences in Serum Amyloid A Levels Between the Treatment Arms (Rilonacept vs. Placebo)|The difference between the treatment arms in serum amyloid A levels (mg/L)|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo|||mg/L||Inter-Quartile Range|Median
1239956|NCT00582907|Secondary|To Determine the Differences in the Fibrinogen Levels Between the Treatment Arms (Rilonacept vs. Placebo)|The differences between treatment arms in the fibrinogen level (micromol/L)|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo|||micromol/L||Inter-Quartile Range|Median
1239957|NCT00582907|Secondary|To Determine the Differences in the Platelet Count Between the Treatment Arms (Rilonacept vs. Placebo)|The difference between the treatment arms in the platelet count X 10 to the power of 9|3 months (each treatment course, overall 12 months)|The number of patients who received at least one course each of rilonacept and placebo|||cell count X10 to the power of 9||Inter-Quartile Range|Median
1239958|NCT00582907|Secondary|To Determine the Differences in C-Reactive Protein Between the Treatment Arms (Rilonacept vs. Placebo)|Differences between the treatment courses in the C-Reactive Protein levels mg/L|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo|||mg/L||Inter-Quartile Range|Median
1239959|NCT00582907|Secondary|To Determine the Differences in the Erythrocyte Sedimentation Rate Between the Treatment Arms (Rilonacept vs. Placebo).|Erythrocyte sedimentation rate - ESR (mm/h)|3 months (each treatment course, overall 12 months)|Participants who completed at least one treatment course of both rilonacept and placebo.|||mm/h||Inter-Quartile Range|Median
1239960|NCT00582907|Secondary|To Determine Differences in the Time to the Development of Attacks Between the Treatment Arms (Rilonacept vs. Placebo).|In a survival analysis we measured the difference (in days) until the development of the first and second attack within a treatment course of up to 3 months and examined differences in this parameter between rilonacept and placebo. Data regarding the development of the second attack are reported below. In regards to the first attack there were no significant differences between rilonacept and placebo (20 days (7.5,>90)for rilonacept; 15 (8,32) for placebo, P=0.066).|3 months|All participants who received an intervention and developed an attack were analyzed.|||days until second attack||Inter-Quartile Range|Median
1239961|NCT00582907|Secondary|To Determine the Proportion of Courses in Which Subjects Attained at Least a 50% Decrease in Acute FMF Attacks During Rilonacept Courses as Compared to Placebo Courses.|Differences between rilonacept and placebo in the percentage of courses that attained at least a 50% decrease in FMF attacks when compared to attacks in the screening period.|Up to 3 months for each treatment course|Participants who completed at least one complete treatment course.|||Percentage of courses|||Number
1239962|NCT00582907|Secondary|Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses.|The percentage of rilonacept and placebo treatment courses without FMF attacks.|Each treatment course of up to 3 months|Participants who at least one complete treatment course.|||Percentage of courses|||Number
1239963|NCT00582907|Secondary|To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo.|This outcome was the difference in days in the length of attacks between rilonacept and placebo.|12 months|Participants who received any treatment and had recorded attacks|||Number of days||95% Confidence Interval|Median
1239964|NCT00582907|Primary|To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo.|Differences in adverse events (AEs) between rilonacept and placebo per patient-month of treatment. We separately analyzed injection site reactions and infectious adverse events. Other adverse events were too small in number to analyze. The upper table (and first statistical analysis) regards injection site reactions and lower table (and second statistical analysis) regards infections.|12 months of entire study length|Safety analysis included all participants who received at least one dose of medication.|||AEs per patient-month of treatment||Inter-Quartile Range|Median
1239965|NCT00582907|Primary|To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks.|Difference in number of attacks per treatment month between rilonacept and placebo|attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)|Patients who received at least one complete treatment course and reported attacks were analyzed for the primary outcome measure.|||number of attacks per month||Inter-Quartile Range|Median
1239966|NCT00582894|Secondary|Number of Participants Overall Survival as a Function of Time.||100 days post transplant|Last observation carried forward|||Participants|||Number
1239967|NCT00582894|Primary|Number of Participants Experiencing Engraftment Donor Chimerism (EDC)||At time of study termination||||Participants|||Number
1239968|NCT00582894|Secondary|Number of Participants Relapse-Free||100 days post-transplant|Last observation carried forward|||Participants|||Number
1239969|NCT00582894|Primary|Number of Participants Experiencing Transplant Related Mortality (TRM)||At Day 100 post trans-plant||||Participants|||Number
1239970|NCT00582816|Secondary|Analysis of NK Cell KIR Expression Over Time|NK cell KIR expression over time will be examined. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Up to 12 months|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.||||||
1239972|NCT00582816|Secondary|NK Expression Levels|Natural Killer (NK) cell expression levels will be explored. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Up to 12 months|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.||||||
1239974|NCT00582816|Primary|Number of Days Until Engraftment Criteria Were Met|"Utilize non-myeloablative conditioning regimen in the haploidentical transplant setting. Engraftment is defined as achieving an absolute neutrophil count ≥ 500 by 28 days post-transplant; platelets and red blood cells will also be measured up to 28 days:~Neutrophils: ≥500/uL for 3 days~Platelets: ≥20 K/uL for 3 days without transfusion~Red blood cells: the date of the last RBC transfusion after achieving transfusion independence Results are reported as number of days until engraftment criteria was met, per neutrophil, platelet and red blood cell measurements, above."|28 days||||days||Full Range|Median
1239975|NCT00582816|Primary|Engraftment Failure|"Utilize non-myeloablative conditioning regimen in the haploidentical transplant setting.~Primary engraftment failure: failure to achieve ANC of ≥500/uL prior to day +28 Late engraftment failure: Initial engraftment achieved with ANC ≥500/uL by day +28 followed by loss of graft Autologous Cells Infused: achieved hematologic recovery following infusions of autologous stem cells Second Haploidentical Transplant: re-transplantation utilizing an alternative haploidentical donor"|28 days||||participants|||Number
1239976|NCT00582816|Primary|Grade III or IV GVHD|"Skin Grade III: Stage 0-4 GVHD, where 0 is no rash and 4 is generalized erythroderma with bullous formation and/or with desquamation Grade IV: Stage 4 GVHD, generalized erythroderma with bullous formation and/or with desquamation~GI (diarrhea) Grade III: Stage 2-4 GVHD, where 2 is > 1000 mL/day but ≤ 1500 mL/day or 556-833 mL/m2, and 4 is severe abdominal pain +/- ileus or stool with frank blood or melena Grade IV: Stage 0-4 GVHD, where 0 is < 500 mL/day or 280 mL/m2, and 4 is severe abdominal pain +/- ileus or stool with frank blood or melena~Overall:~Grade III: Grade III Skin and/or GI as well as bilirubin 3.1-15 mg/dl Grade IV: Grade IV Skin and/or GI as well as bilirubin > 15 mg/dl"|Day 100||||participants|||Number
1239977|NCT00582790|Secondary|Number of Participants With Immunologic Responses|Blood was collected to analyze T-cell populations from all patients prior to treatment on day 1 of cycles 1 and 2, and days 4 and 8 of cycles 1 and 2. Changes in gamma delta T-cell population and CD3 T-cell populations were reported.|baseline to cycle 2 day 8|One patient did not receive study treatment and so was not included in the analysis.|||participants|||Number
1239978|NCT00582790|Secondary|Number of Participants With Toxicities|Patients were observed for toxicities. The National Cancer Institute Common Terminology Criteria Version 2.0 was used to categorize and report adverse events.|Baseline to 30 days after last dose of study treatment|Patients who received at least one dose of study medication. One of the 12 patients never received study medication so only 11 were evaluable for toxicity|||participants|||Number
1239979|NCT00582790|Secondary|Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks|All 12 patients were followed for survival until death. 8 participants who received more than one cycle of treatment and who were considered evaluable for response were followed until time to progression. Disease progression was determined by CT scans of the chest/abdomen/pelvis obtained every 2 cycles and based on RECIST version 1.0. Progression is defined using RECIST (V1.0) at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|Time frame is from study entry until time to disease progression and time to death, up to 50 months|8 of the 12 participants who received more than 1 cycle of therapy and were considered evaluable for time to progression. All 12 were evaluated for survival|||participants|||Number
1239980|NCT00582790|Primary|Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid|Anti-tumor response was measured per RECIST criteria (V1.0) and assessed by chest/abdomen/pelvis CT: Complete Response (CR), disappearance of all target lessions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Response (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|CT scans obtained at baseline, then every 2 cycles|Anti tumor response was measured in those patients who completed at least 1 cycle of study treatment 4 subjects did not complete 1 cycle of treatment.|||participants|||Number
1239981|NCT00582738|Secondary|Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at 12 and 24 Months Post Randomization|End of Study (EOS) endpoint is the last available assessment on or after Month 12. A reduction of at least two logs in HCV RNA viral load was considered as success|baseline, 12 months, 24 months/EOS|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. If 12-month HCV was the last available assessment, this value is used to impute the End of Study value.|||log10 copies/ml||Standard Deviation|Mean
1239982|NCT00582738|Secondary|Percentage of Patients in Each Study Arm With Increase of ≥1 Point in the Ishak-Knodell Staging Score in Fibrosis|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite.|baseline to month 24|Difference Ishak-Knodell Score at End-of-Study The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication|||percentage of participants|||Number
1239983|NCT00582738|Secondary|Comparison of the Effect of Both Regimens on the Inflammatory (Acti-test) and Fibrosis (Fibro-test) Components of Fibrosure, and on Fibrosis Area Assessed by Histomorphometry|"The Fibrosure test is the combination of Fibro-test + Acti-test.~FibroTest (FT) was for the assessment of fibrosis. Fibro test was calculated using an original combination of five highly concentrated serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin and gammaglutamyltransferase (GGT). FibroTest scores range from 0.00 to 1.00 where 0.0-0.21 is no fibrosis and >= 0.59 is cirrhosis.~Acti-test was calculated using 6 serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and alanine aminotransferase (ALT). ActiTest (AT) was used for the assessment of necroinflammatory activity. Test score ranges from 0.00 to 1.00, where 0.00-0.17 indicates no necrosis and >= 0.61 indicates severe necrosis~If 12-month Actitest value was the last available assessment, the value is used to impute the final staging score(End of Study)"|baseline, 12 and 24 months|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.|||units on a scale||Full Range|Median
1239984|NCT00582738|Secondary|Comparison of the Effect of Both Regimens in the Necroinflammatory Grading Score (Ishak-Knodell) (Portal Inflammation)|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite|baseline, 12 months, 24 months|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.|||Score on a scale||Standard Deviation|Mean
1239985|NCT00582738|Secondary|Comparison of Renal Function (Glomerular Filtration Rate [GFR] Calculated Using the Modification of Diet in Renal Disease Study Group [MDRD] Formula) Between Study Groups|"GFR Month 9 value if available, otherwise minimal first year post-randomization available value. Imputation rule of missing Month 24 GFR values: GFR Month 18 value if available, otherwise Month 12 GFR is used.~Least square means are from an ANCOVA model containing treatment as factor and baseline eGFR as a covariate."|12 months, 24 months/EOS|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.|||mL/min/1.73^2||Standard Error|Least Squares Mean
1239986|NCT00582738|Secondary|Number of Patients With Events (Progression to Cirrhosis, Retransplantation, HCV Related Death, First BPAR, Graft Loss)at 12 and 24 Months||12 months, 24 months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.|||participants|||Number
1239987|NCT00582738|Secondary|Percentage of Patients With Death, Graft Loss and Biopsy Proven Acute Rejection (BPAR) Between Study Groups||24 Months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication.|||Percentage of Participants|||Number
1239988|NCT00582738|Secondary|Change From Baseline in Fibrosis Metavir Scoring at 12 and 24 Months Post Randomization|Metavir Score: F0=No fibrosis; F1=Portal fibrosis without septa; F2=Portal fibrosis with rare septa; F3=Numerous septa without cirrhosis Decrease in score from baseline indicates improvement|Baseline, 12 months, 24 months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. Only participants with observations at baseline and specified timepoints were included in the analysis.|||Scores on a Scale||Full Range|Median
1239989|NCT00582738|Primary|Change From Baseline in Fibrosis Staging Score (Measured by the Ishak-Knodell Staging Score) Between Baseline and 24 Months Post-transplant.|"Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite~Decrease in score from baseline indicates improvement"|baseline, 24 Months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. Small number of biopsies obtained at Month 24 due to study being prematurely terminated.|||Score on Scale||Full Range|Median
1239990|NCT00582712|Primary|Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)||1 year|No data was ever analyzed, resulted, or published on this study.||||||
1239991|NCT00582660|Primary|Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot|At 72 hours after start of treatment, the number of subjects with immunoblot demonstrated a 1.5 to 2 fold increase in 15-LOX-1 protein expression in human colorectal adenocarcinoma cell line with epithelial morphology(HT-29) and dihydrolipoamide dehydrogenase(DLD)-1 cells.|baseline to 72 hours||||Participants|||Number
1239992|NCT00582660|Primary|Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib|"The Colo-Rectal adenocarcinoma will be measured by cyclooxygenase-2(COX-2) activity at 7 days post baseline. Cox-2 activity is measured by assessing tumors and normal tissue using Electron microscope and Tandem mass Spectrometry methodology though the UAB shared Mass Spectrometry facility. Improvement was measured by 2-fold increase in COX-2 activity from baseline. The methodology used was High Performance Liquid Chromatography(HPLC). additional studies include expression of genes thought to be important in colorectal carcinogenesis: COX-1 and 2, MMP, 2 7, and 9, tissue inhibitor of metalloproteinases(TIMPs) 1 ans 2 and beta-catenin."|baseline to 7 days||||Participant|||Number
1239993|NCT00582608|Primary|Safety and Toxicity is Measured by the Total Number of Participants Affected|Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.|2 years||||Participants|||Count of Participants
1239994|NCT00582556|Secondary|Number of Subjects With Decreases in Prostate Specific Antigen (PSA) After Zoledronic Acid Prior to Beginning Androgen Deprivation Therapy|"PSA response was measured by observing the serum PSA one week after beginning zoledronic acid and prior to beginning androgen deprivation therapy.~Arm 2 and Arm 3 were not able to be assessed for this endpoint as all subjects were on androgen deprivation prior to receiving zoledronic acid."|2 Years||||participants|||Number
1239995|NCT00582556|Secondary|Number of Subjects Had a Significant Change in Immune Markers.|Immune markers were measured by isolating gamma-delta T cells one month after treatment with zoledronic acid.|2 Years||||participants|||Number
1239996|NCT00582556|Secondary|The Number of Subjects Who Had a Significant Increase of Peripheral Blood Markers of Bone Turnover.|Serum bone-specific alkaline phosphatase was collected as the blood marker of bone turnover.|2 years||||participants|||Number
1239997|NCT00582556|Primary|The Number of Subjects Who Had Either an Increase or Decrease on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Men Undergoing Androgen Deprivation Therapy for Prostate Adenocarcinoma.|Effects on bone mineral density were measured at four locations at six month intervals for 24 months.|2 years||||participants|||Number
1239999|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 3 Weeks|The number of participants who completed the study were analyzed.|||Millimeters||Standard Deviation|Mean
1240000|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 2 Weeks|The number of participants who completed the study were analyzed.|||Millimeters||Standard Deviation|Mean
1240001|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 3 Weeks|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
1240002|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 2 Weeks|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
1240003|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 1 Week|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
1240004|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 3 Weeks|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
1240005|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 2 Weeks|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
1240006|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 1 Week|The number of participants who completed the study were analyzed.|||Millimeters||Standard Deviation|Mean
1240007|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 1 Week|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
1240008|NCT00582426|Secondary|Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D)|Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point.|Baseline to Day 168|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.|||Units on a scale||Standard Deviation|Mean
1240009|NCT00582426|Secondary|Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)|Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as > 20 mm with conventional techniques (CT, MRI) or as > 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.|Day 56, Day 84, Day 112, Day 140, Day 168|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. N in each category indicates the number of patients analyzed with observations at that timepoint."|||Percentage of Participants||95% Confidence Interval|Number
1240010|NCT00582426|Secondary|Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."|||Percentage of Participants||95% Confidence Interval|Number
1240011|NCT00582426|Secondary|Percentage of Patients Hospitalized Due to Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."|||Percentage of patients|||Number
1240012|NCT00582426|Secondary|Percentage of Participants Who Need Opioids for Control of Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."|||Percentage of Participants||95% Confidence Interval|Number
1240013|NCT00582426|Secondary|Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea|For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient discontinued from the Octreotide LAR arm due to exclusion criteria after visit 1.|||Percentage of participants||95% Confidence Interval|Number
1240014|NCT00582426|Secondary|Percentage of Episodes by Grade|Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.|||Percentage of Episodes|Participants||Number
1240015|NCT00582426|Secondary|Percentage of Patients by Grade of Diarrhea|Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.|||Percentage of Participants|||Number
1240016|NCT00582426|Secondary|Number of Episodes of Diarrhea by Patient by Cycle|Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.)|at each cycle (28 days per cycle)|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. n indicates patients with observations during each cycle."|||Episodes/patient/cycle||Standard Deviation|Mean
1240017|NCT00582426|Secondary|Number of Episodes of Diarrhea by Patient|Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.|||Episodes/patients/day||Standard Deviation|Mean
1240018|NCT00582426|Primary|Percentage of Participants Developing Diarrhea (Grade 1 to 4)|The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 month overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."|||Percentage of Participants||95% Confidence Interval|Number
1240019|NCT00582400|Secondary|Progression Free Survival|Time to progression from start of treatment|6 years|1 evaluable participant lost to follow up. No data collected.||||||
1240020|NCT00582400|Secondary|Duration of Response.|Time to progression.|6 years|Participants with response|||months||Full Range|Median
1240021|NCT00582400|Primary|Number of Patients With Response to Treatment (RECIST Criteria)|Response included complete response, partial response or stable disease.|6 years|Participants who were evaluable for response|||participants|||Number
1240022|NCT00582400|Primary|Number of Participants With Treatment Related Toxicity.||6 years||||participants|||Number
1240023|NCT00582361|Primary|Infections|Number of acute, delayed and deep wound infections.|Up to 12 months||||Number of infections|||Number
1240024|NCT00582361|Primary|Healing of Orthopaedic Trauma Open Fractures|Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)|from surgery to wound closure||||use days||Full Range|Mean
1240025|NCT00582309|Primary|Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.|The protocol were compared by measuring in each patient time to acquire the Blood Glucose (BG) target range (80-120 mg/dl) defined by reaching a BG < 120, and maintaining the target range thereafter.|24 hours||||Time to reach glycemic control in hours||Standard Deviation|Mean
1240026|NCT00582205|Secondary|Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity||3 years||||Participants|||Count of Participants
1240027|NCT00582205|Primary|Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.||3 years||||Participants|||Count of Participants
1240030|NCT00582166|Secondary|Response Rates|To estimate the Complete Response and unconfirmed Complete Response rate (assessing Ibritumomab tiuxetan). Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms, and all dominant lymph nodes and nodal masses have regressed to normal size, and complete resolution of lymphoma in the bone marrow biopsy. Unconfirmed Complete Response (CRu) defined as the above, but with either a > 1.5cm residual node that has decreased by >75%, and/or individual nodes that were previously confluent that have decreased by >75% in SPD, and/or indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).|Up to 5 years and 9.5 months||||percentage of participants||95% Confidence Interval|Median
1240031|NCT00582166|Secondary|24-month Progression Free Survival (PFS)|"Estimate the 24 month progression free survival (PFS), where PFS is defined as the number of days from the first Ibritumomab tiuxetan administration (day 0) to the day the patient experiences an event of disease progression (or death). PFS is summarized as the percentage of patients that survived progression free after 24 months.~Progression is defined as any of the following:~- Appearances of any new lesions/sites during or after therapy.~Increase of >/= 50% in the SPD (sum of perpendicular diameter) from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site.~Increase by > 50% in greatest diameter from nadir measurement of any previously involved dominant node > 1.0 cm in its short axis."|Up to 24 months||||Participants|||Count of Participants
1240032|NCT00582166|Primary|Median Progression Free Survival (PFS)|Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma).|up to 5 years, 9.5 months, from first day on treatment to last follow up|The study was stopped prematurely, subjects were not followed for a full 7 years. We have data for 16 subjects, 6 experienced a progression event, 10 survived progression-free through last follow-up. Date of last follow-up is used to calculate progression-free survival for those who did not experience progression.|||months||80% Confidence Interval|Median
1240033|NCT00582114|Other Pre-specified|Serious Adverse Events and Cardiovascular Events That Led to Trial Termination|Cardiovascular events were counted by subject and included the following: myocardial infarction (MI), stroke, hospitalization for congestive heart failure (CHF), hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. Adverse events reported are those during the course of 12 months of participation in the trial. All serious adverse events were adjudicated by R.A. and A.D.S. who were masked to the drug assignment at the time of adjudication. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. The cardiovascular event rate was calculated by treatment group assignment. Incidence rate ratio (IRR) by treatment was then determined along with the 95% confidence intervals (95% CIs). As a post hoc analysis, we also determined the narrower definition of cardiovascular events per group that included MI, stroke, CHF, or cardiovascular death.|1 yr||||events/100 patient-years|||Number
1240034|NCT00582114|Primary|The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.|The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. A mixed model was used with left ventricular mass index (LVMI) as the outcome variable. Fixed effects were indicator variables for time, treatment and their interaction. Random effect was subject and statistical inference was made using the maximum likelihood estimator. No imputation was made for missing data.|Baseline, 6 months, 12 months|The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. The analysis was performed by intention to treat, if the patient received at least one dose of the randomized drug regardless of the availability of a post-baseline echocardiogram.|||g/m^2||Standard Deviation|Mean
1240035|NCT00582075|Secondary|Overall Survival||2 years||||weeks||Full Range|Median
1240036|NCT00582075|Primary|Percentage of Participants With Distant Brain Failure (DBF) at One Year|Patients developing distant brain failure (DBF) at one year. An approximation method was used to arrive at the reported percentage.|1 years||||percentage of participants|||Number
1240037|NCT00582036|Primary|Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)||100 days|Due to early termination, data not analyzed|||Participants|||Number
1240038|NCT00582036|Secondary|Reduced Length of In-hospital Stay||About 100 days|||||||
1240039|NCT00582036|Secondary|Reduction of Infection||About 100 days|||||||
1240040|NCT00582010|Primary|Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery|Number of any complication reported by subjects at 9 months after surgery|baseline to 9 months post surgery||||complications|||Number
1240041|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)|Number of complications due to hepatobiliary events.|baseline to 9 months after transplantation||||Complications|||Number
1240042|NCT00582010|Secondary|Effect of iNO on SICU Stay|Number of minutes after surgery subject remained in SICU|baseline to discharge for SICU||||minutes||Inter-Quartile Range|Mean
1240043|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)|A positive percent reflects an decrease; a negative percentage reflects a increase.|baseline and 96 hours after baseline||||percent change from baseline||Standard Deviation|Mean
1240044|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))|The faster the percent increase of PT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase.|baseline and 96 hours after baseline||||percentage change from baseline||Standard Deviation|Mean
1240045|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)|The faster the percent increase of alkaline phosphatase reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an increase; a negative percentage reflects a decrease.|baseline and 96 hours after baseline||||percentage change from baseline||Standard Deviation|Mean
1240046|NCT00582010|Primary|Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)|The faster the percent decrease ALT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. . (ALT levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of ALT relative to baseline).|baseline and 96 hours after baseline||||percentage change from baseline||Standard Deviation|Mean
1240047|NCT00582010|Secondary|Effect of iNO on Hosptial Length of Stay|number of days subject in hospital after surgery until discharge|from surgery through discharge from hospital||||days||Inter-Quartile Range|Mean
1240048|NCT00582010|Primary|Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)|The faster the percent decrease of AST reflect the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. The rate was calculated by measuring AST levels at baseline and at 96 hours post baseline. (AST levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of AST relative to baseline).|baseline and 96 hours after baseline||||percentage change from baseline||Standard Deviation|Mean
1240049|NCT00581971|Primary|Response as Evaluated by Recurrence of Diseases|Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.|2 years from end of treatment (Radiation therapy)||||Participants|||Number
1240050|NCT00581971|Primary|Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.|Particpants experiencing Acute Toxicities > Grade 3|2 years from radiation therapy||||participants|||Number
1240051|NCT00581945|Primary|Change From Baseline in Forced Expiratory Flow 25% to 75%|The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population|||L/sec||Standard Deviation|Mean
1240052|NCT00581945|Primary|Change From Baseline in Slow Vital Capacity (SVC)|Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population|||liters||Standard Deviation|Mean
1240053|NCT00581945|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population|||liters||Standard Deviation|Mean
1240054|NCT00581945|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted|"The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function."|Baseline, Week 25 and Week 45|Safety population|||Percent of predicted||Standard Deviation|Mean
1240055|NCT00581945|Secondary|Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events|Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation. A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.|Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.|The safety population consisted of all randomized patients who received at least one dose of the study drug.|||Participants|||Number
1240056|NCT00581945|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.|Baseline, Week 25 and Week 45|The safety population consisted of all randomized patients who received at least one dose of the study drug.|||Liters||Standard Deviation|Mean
1240057|NCT00581919|Secondary|Progression-free Survival|Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.||||months||Full Range|Median
1240058|NCT00581919|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed up to 7 years||||months||Full Range|Median
1240059|NCT00581919|Primary|Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR|"Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner.~Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy.~Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis."|Every 21 days, up to 24 weeks||||percentage of participants||90% Confidence Interval|Number
1240087|NCT00581386|Primary|Post Operative Morbidity|We followed the patients 2 and 24 hours after the surgery for sore throat, hoarseness and dysphagia.The numbers represented here are the number of patients who reported sore throat at 2 hrs and after 24 hrs as per the protocol.|2 hrs and 24 hrs after surgery|As per protocol,all the patients were followed up at 2 hrs and 24hrs to check for any postoperative hoarseness, sorethroat and difficulty swallowing. The numbers represent the number of patients who complained of postoperative morbidity.|||participants|||Number
1240060|NCT00581867|Secondary|Global Cognition|Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale [WMS]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale [WAIS] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination [MMSE]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average.|90 mins||||z-scores||Standard Deviation|Mean
1240061|NCT00581867|Primary|fMRI Measure of Hippocampal Activation|Percentage active voxels of total hippocampal volume of interest|30 minutes After Intervention Administration||||percentage of active voxels||Standard Deviation|Mean
1240062|NCT00581854|Primary|Complete Response Rate to Induction Therapy|Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).|Median follow up of 37 months|All Subjects enrolled were included in the analysis. Response rate is represented as % of total subjects enrolled.|||percentage of participants||90% Confidence Interval|Number
1240063|NCT00581828|Primary|Change in Intestinal Calcium Absorption From Baseline to One Month|percent and true fractional calcium absorption|1 month|One subject's urine sample was mishandled, leaving 18 subjects with complete data for analysis.|||percent calcium absorption||Standard Deviation|Mean
1240064|NCT00581776|Secondary|3 Year Overall Survival (OS)|This is the percent of participants who were still alive at 3 years after study entry.|36 months||||Percent of participants||95% Confidence Interval|Number
1240065|NCT00581776|Secondary|3 Year Progression Free Survival|This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.|36 months||||percent of participants||95% Confidence Interval|Number
1240066|NCT00581776|Primary|Complete Response Rate (CR) at the End of Induction Chemotherapy|Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.|at 21 weeks||||percent of participants||95% Confidence Interval|Number
1240067|NCT00581776|Primary|Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).|"Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy.~1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses."|At completion of induction therapy (21 weeks)||||Percent of participants||95% Confidence Interval|Number
1240068|NCT00581581|Primary|WeeFIM Score|WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from “1” for total assistance, total dependence, maximal prompting, or not testable to “7” for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response.|7-8 years after initial intervention||||percentage of participants|||Number
1240069|NCT00581555|Secondary|Percentage of Rebound Effects|Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.|Baseline to Week 24.|ITT population: included all randomized participants.n equals number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1240070|NCT00581555|Secondary|DLQI at Each Visit From Baseline|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Baseline to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data|||scores on a scale||Standard Error|Mean
1240071|NCT00581555|Secondary|Change From Randomization in DLQI to Week 24|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||scores on a scale||95% Confidence Interval|Mean
1240072|NCT00581555|Secondary|Percent (%) Change of PASI Score From Randomization to Week 24|Percent improvement in PASI score was calculated from Week 6 to Week 24.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||percent change||95% Confidence Interval|Mean
1240088|NCT00581386|Primary|Leak Pressures|The maximum leak pressure attained for each device.|Duration of surgery||||cm of H2O||Standard Deviation|Mean
1240089|NCT00581386|Primary|Number of Patients Who Required Multiple Attempts.|The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.|Time taken for intubation|As per protocol,the number of cases in whom the device could not be placed successfully in first attempt and required 2nd and 3rd attempts.|||Participants|||Number
1240073|NCT00581555|Primary|Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)|PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.|Randomization to Week 24.|Intent-To-Treat (ITT) population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||scores on a scale||95% Confidence Interval|Mean
1240074|NCT00581555|Secondary|Probability of Being Relapse Free During the 24 Weeks After Randomization|Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||probability of relapse free|||Number
1240075|NCT00581555|Secondary|Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization|Relapse was defined as the loss of 50% improvement in PASI.|Randomization to Week 24.|ITT population: that included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||Percentage of participants|||Number
1240076|NCT00581555|Secondary|Change From Randomization in PGA Score to Week 24|PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||scores on a scale||95% Confidence Interval|Mean
1240077|NCT00581555|Secondary|PASI Area Under the Curve (AUC) Between Randomization and Week 24|PASI AUC = Area under the curve from randomization (Week 6) to Week 24.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data.|||scores on a scale * weeks||Standard Error|Mean
1240078|NCT00581542|Secondary|Number of Participants With a Negative Bacterial Culture|Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified.|10 days|Only participants who were culture positive at baseline were tested at day 10. 20 participants were negative at baseline in the polytrim group and 11 participants were negative in the moxifloxin group.|||participants|||Number
1240079|NCT00581542|Primary|Number of Participants With Normal Physical Examination of the Eye||10 days||||participants|||Number
1240080|NCT00581529|Secondary|Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis|One of the studies secondary outcomes was to evaluate the impact of short term accelerated partial breast radiation therapy on cosmetic results. To determine the association between dosimetric factors and cosmesis, the mean percentage of prescription dose received to WBV (Whole breast volume: corresponding region typically encompassed by traditional tangent fields) was compared among participants who developed fair/poor (F/P) cosmetic outcomes (unacceptable cosmesis) and participants who maintained excellent/good (E/G) cosmetic outcomes (acceptable cosmesis).|5 years|34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis.|||Percentage of reference volume||Full Range|Mean
1240081|NCT00581529|Secondary|Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods|Dosimetric and volumetric differences between treatment plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20.|not specific|At the time the study was written, we planned to compare treatment methods. Over the course of the study, it was determined additional analysis was not needed due to the analysis and publication of this outcome by several other investigators.||||||
1240082|NCT00581529|Primary|Percentage of Participants That Experience Cosmetic Adverse Events (AEs)|The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.|5 years|34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis. 2 additional patients underwent mastectomies and were therefore excluded from analysis (cosmesis could not be assessed at 5 years). 30 patients were analyzed.|||percentage of participants|||Number
1240083|NCT00581529|Primary|Rate of Local Control at 5 Years|The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.|5 years|34 for patients were enrolled and treated.|||percentage of participants|||Number
1240084|NCT00581399|Secondary|Duration of Mediastinal Drainage|The outcome to measure is the duration of the chest tubes inserted in the patient in hours. The time starts at the time the chest is completely closed and the end time when the chest tubes are pulled out of the patient's chest.|Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient||||Hours||Standard Deviation|Mean
1240085|NCT00581399|Primary|Amount of Postoperative Bleeding|The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.|24-48 hours post surgery||||mL||Standard Deviation|Mean
1240086|NCT00581386|Primary|Number of Failed Cases|We calculated the number of failed cases. As per protocol, that is number of patients in whom successful intubation was not achieved with the assigned device after 3 attempts.|Time taken for successful intubation|As per protocol, a case is decided as a failed case when the patient was not able to be intubated with the assigned device after 3 attempts.|||Participants|||Number
1240090|NCT00581386|Primary|Number of Participants With a Successful First Attempt Placement|The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.|Time taken for successful placement|As per protocol,of all the patients intubated with the assigned specific device number of patients in whom the device was placed successfully in the first attempt.|||Participants|||Number
1240091|NCT00581386|Primary|Duration of Intubation|The time taken to successfully place the device in seconds.|duration of intubation||||seconds||Standard Deviation|Mean
1240092|NCT00581360|Secondary|Median Duration of Stable Disease Response|Median number of months of Stable Disease Response Per RECIST v1.0 (Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)|Up to 36 months||||months||Full Range|Median
1240093|NCT00581360|Secondary|Number of Months of Survival|Number of months that the participant was alive.|Up to 5 years||||months|||Number
1240094|NCT00581360|Secondary|Number of Months of Progression-free Survival (PFS)|Number of months that participants experienced stable disease (the disease does not progress per RECIST v1.0 criteria - Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)|Up to 5 years||||months|||Number
1240095|NCT00581360|Primary|Stable Disease Rate|Using RECIST v1.0 criteria, stable disease rate is the number participants experiencing stable disease (SD) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD).|Up to 5 years|All patients in this population had stable disease as best response.|||percentage of participants|||Number
1240096|NCT00581360|Primary|Objective Response Rate (ORR)|ORR is the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD). RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest s|Up to 5 years||||percentage of participants|||Number
1240097|NCT00581347|Secondary|Receipt of a Well Child Visit Within a 12 Month Period|We compared the number of participants in the intervention group who received a well child visit within a 12 month period versus those in the control group.|1 year||||participants|||Number
1240098|NCT00581347|Primary|Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)|We compared the number of participants in the intervention group who received vaccinations for Tdap, Menactra, and (for girls only) HPV at the end of the study period versus those in the control group.|15 months||||participants|||Number
1240099|NCT00581308|Primary|Safety|A calculation of the proportion of subjects experiencing one or more major device or procedure related adverse event(s) at 1, 2, 3, 4, and 5 years post procedure.|5 years||||Participants|||Count of Participants
1240100|NCT00581308|Primary|Efficacy|"A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure.~Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:~Any major device/procedure adverse event~Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.~Clinically significant leak at the follow-up visit"|60 months|Subjects with Successful Device Delivery|||Participants|||Number
1240101|NCT00581308|Primary|Efficacy|"A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure.~Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:~Any major device/procedure adverse event~Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.~Clinically significant leak at the follow-up visit"|36 months|Subjects with Successful Device Delivery|||Participants|||Number
1240102|NCT00581308|Primary|Efficacy|"A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:~Any major device/procedure adverse event~Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.~Clinically significant leak at the follow-up visit"|12 months|Subjects with Successful Device Delivery|||Participants|||Number
1240103|NCT00581256|Secondary|The Number of Participants That Experience Pericarditis and Pneumonitis|"To compare rates of pericarditis and pneumonitis by treatment arm.~Pericarditis (inflammation of the pericardium):~Grade1: Asymptomatic, ECG or physical exam; changes consistent with pericarditis Grade 2: Symptomatic pericarditis Grade 3: Pericarditis with physiologic consequences Grade 4: Life-threatening Pneumonitis (inflammation of the walls of the alveoli in the lungs) Grade 1: Asymptomatic, radiographic findings only Grade 2: Symptomatic, not interfering with ADL (activities of daily living) Grade 3: Symptomatic, interfering with ADL Grade 4: Life-threatening"|approx 1 year||||participants|||Number
1240104|NCT00581256|Secondary|Number of Participants With New Lung Perfusion Defects|To compare changes in lung perfusion defects by treatment arm. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution’s normal polar map databases for the left anterior descending artery (LAD).|baseline to approx 1 year|One patient randomized to the IMRT arm did not receive her post-RT lung SPECT scan therefore pre- and post-radiotherapy Lung SPECT scans were available for 53 patients.|||participants|||Number
1240105|NCT00581256|Secondary|Mean Percent Change in Ejection Fraction (LVEF)|To compare change in ejection fraction between treatment arms.|baseline to approx 1 year||||percent change||Full Range|Mean
1240106|NCT00581256|Primary|The Number of Participants With a Significant Increase in Perfusion Defects (PD)|To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution’s normal polar map databases for the left anterior descending artery (LAD) using thresholds of 2.5-SD (standard deviation) and 1.5-SD below the normal mean. On the basis of interest variability, a PD increase greater than 5% or 10% was considered significant for 2.5- and 1.5-SD thresholds, respectively.|1 Year||||participants|||Number
1240107|NCT00581230|Primary|Glottic View as Assessed by the Cormack and Lehane Classification|Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible|before intubation||||participants|||Number
1240108|NCT00581230|Primary|Ease of Mask Ventilation as Assessed by Han Class|Grading Scale for Mask Ventilation as described by Han et al. (Anesthesiology. 2004 Jul;101(1):267) Grade 0. Ventilation by mask not attempted Grade 1. Ventilated by mask Grade 2. Ventilated by mask with oral airway/adjuvant with or without muscle relaxant Grade 3. Difficult ventilation (inadequate, unstable, or requiring two providers) with or without muscle relaxant Grade 4. Unable to mask ventilate with or without muscle relaxant|Time before intubation||||participants|||Number
1240109|NCT00581113|Primary|Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.|Brain metastases bi-dimensional area|12 months post RT|Not enough patients were enrolled to allow for any meaningful analysis.||||||
1240110|NCT00581113|Secondary|Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.|Increase in the bi-dimensional tumor area for any of the tracked brain metastases or the appearance of any new brain metastases on a follow-up MRI.|12 months after end of radiation therapy|Study terminated early due to poor accrual||||||
1240111|NCT00581100|Secondary|Change From Baseline in Physician Fingernail Grading Assessment Total Score|Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
1240112|NCT00581100|Secondary|Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
1240113|NCT00581100|Secondary|Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
1240114|NCT00581100|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI)|Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
1240115|NCT00581100|Secondary|Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).|Baseline, Week 24 or Early Termination|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
1240116|NCT00581100|Secondary|Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline, Week 24 or Early Termination|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
1240117|NCT00581100|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Psoriasis|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||unts on a scale||95% Confidence Interval|Mean
1240118|NCT00581100|Secondary|Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12 , Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
1240119|NCT00581100|Secondary|Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12 , Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
1240120|NCT00581100|Secondary|Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
1240121|NCT00581100|Secondary|Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Week 12, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale|||Number
1240122|NCT00581100|Secondary|Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Week 12, Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
1240123|NCT00581100|Secondary|Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.|Week 12, Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
1240124|NCT00581100|Secondary|Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.|Week 12, Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
1240125|NCT00581100|Secondary|Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
1240126|NCT00581100|Primary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.|Baseline, Week 24|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least one dose of study medication, and provided baseline and post-baseline data. N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
1240127|NCT00581061|Secondary|Side Effects|Number of people who experienced side effects while taking Vesicare, per study protocol.|3 months||||participants|||Number
1240128|NCT00581061|Secondary|Compliance|Number of subjects that were in compliance with the study protocol and took medication for at least one month.|3 months|per protocol|||participants|||Number
1240129|NCT00581061|Primary|Time to Continence|Time in days to achieve pad free urinary continence|12 months||||days||Standard Deviation|Mean
1240133|NCT00581048|Primary|Effect of Natural-source d-α-tocopheryl Acetate on the Baseline and Allergen-induced Levels of F2-isoprostanes in the Bronchoalveolar Lavage Fluid (BAL)||At baseline to after 16-18 weeks of treatment with vitamin E daily|Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 1 for diagram of results||||||
1240134|NCT00580983|Secondary|The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures|To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.|5 years||||Gray (Gy)||Standard Deviation|Mean
1240135|NCT00580983|Primary|Percentage of Participants With Grade 0-1 Observer-rated Dysphagia|To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.|12 months|90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were analyzed.|||percentage of participants|||Number
1240136|NCT00580970|Primary|Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment|The primary endpoint of this study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. A one sided test will be conducted in order to evaluate reduction of risk from adding Lovastatin. The analysis is using a one-stage design, 5% level of significance, and 83% power.|24 months|The primary endpoint of the study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. Only the highest-grade toxicity for each symptom was counted. Symptoms starting in the acute period and unresolved beyond 90 days post treatment are considered late toxicity.|||percentage of participants|||Number
1240137|NCT00580957|Primary|Insulin Resistance|Glucose infusion rate in mg/kg/min|Last 30 minutes of a two hour insulin clamp||||mg/kg/min||Standard Error|Mean
1240138|NCT00580866|Secondary|Disabilities of the Arm, Shoulder and Hand (DASH) Score|Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )|12 months post-operatively||||scores on a scale||95% Confidence Interval|Mean
1240139|NCT00580866|Primary|Elbow ROM at 12 Months|The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.|2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively|Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment.|||degrees||95% Confidence Interval|Mean
1240140|NCT00580853|Secondary|Number of Cigarettes Smoked During the 60 Minute Ad-lib Period|number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period|60 minutes||||number of cigarettes||Standard Error|Mean
1240141|NCT00580853|Primary|Latency to Initiate Ad-lib Smoking Session|minutes to start smoking (range 0 to 50 minutes)|0 to 50 minutes|Subsample with high nicotine dependence|||minutes||Standard Error|Mean
1240142|NCT00580840|Other Pre-specified|Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Swollen Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Joints||Standard Error|Least Squares Mean
1240143|NCT00580840|Other Pre-specified|Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Tender Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Joints||Standard Error|Least Squares Mean
1240144|NCT00580840|Other Pre-specified|Change From Baseline in PhGADA (Physician’s Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Physician’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240145|NCT00580840|Other Pre-specified|Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18|Ratio is defined as the ESR value at Week 34 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (69 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Ratio||95% Confidence Interval|Least Squares Mean
1240146|NCT00580840|Other Pre-specified|Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients|Ratio is defined as the ESR value at Week 16 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1240230|NCT00580502|Primary|To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery|Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.|5 years|All participants who underwent LAGB are included in the analysis population.|||percentage of excess weight loss||Standard Deviation|Mean
1240147|NCT00580840|Secondary|Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18.|ACR20 loss are subjects with <20% improvement from Baseline for tender joint count, swollen joint count, and at least 3/5 core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein, 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale at 2 consecutive visits. Subjects losing response for 2 consecutive visits are considered as having the event on the day of the visit where response was first lost.|Week 18 up to Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis.|||days||Inter-Quartile Range|Median
1240148|NCT00580840|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240149|NCT00580840|Secondary|Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240150|NCT00580840|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240151|NCT00580840|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240152|NCT00580840|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240153|NCT00580840|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (67 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240154|NCT00580840|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240249|NCT00580047|Secondary|Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation|Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast.|24 months|Compliance in study arm|||percentage of compliance|||Number
1240155|NCT00580840|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240156|NCT00580840|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240157|NCT00580840|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240158|NCT00580840|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240159|NCT00580840|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240160|NCT00580840|Secondary|Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Week 34 minus the Baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240161|NCT00580840|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 34 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240162|NCT00580840|Secondary|Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18|Ratio is defined as the CRP value at Week 34 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Ratio||95% Confidence Interval|Least Squares Mean
1240226|NCT00580606|Primary|Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.|Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||Percentage of participants|||Number
1240163|NCT00580840|Secondary|CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity."|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
1240164|NCT00580840|Secondary|SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
1240165|NCT00580840|Secondary|DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
1240166|NCT00580840|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. Range for CDAI is 0-76 with a lower CDAI score reflects approvement in activity and a higher score reflects a decline.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240167|NCT00580840|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240168|NCT00580840|Secondary|Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (69 400 mg CZP, 68 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1240169|NCT00580840|Secondary|Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
1240170|NCT00580840|Secondary|Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
1240171|NCT00580840|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1240172|NCT00580840|Secondary|Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients|Ratio is defined as the CRP value at Week 16 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1240173|NCT00580840|Secondary|CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity."|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
1240174|NCT00580840|Secondary|SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
1240175|NCT00580840|Secondary|DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
1240176|NCT00580840|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline, Week 16|Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1240177|NCT00580840|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Baseline, Week 16|Of the 333 subjects in the Run-in period, 326 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1240178|NCT00580840|Secondary|Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Baseline, Week 16|Of the 333 subjects in the Run-in period, 325 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1240179|NCT00580840|Secondary|Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
1240227|NCT00580502|Secondary|Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of HbA1c from baseline at 5 years|5 years|All participants who underwent LAGB and had 5 year f/u visit are included in the analysis population.|||percentage of HbA1c||Standard Deviation|Mean
1240180|NCT00580840|Secondary|Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
1240181|NCT00580840|Secondary|Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
1240182|NCT00580840|Primary|Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
1240183|NCT00580801|Secondary|Average Steady-State Serum Concentration (Css,av) of Telaprevir|The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."|||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1240184|NCT00580801|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir|The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."|||Hours||Full Range|Median
1240185|NCT00580801|Secondary|Minimum Serum Concentration (Cmin) of Telaprevir on Day 15|The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."|||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1240186|NCT00580801|Secondary|Pre-Dose Serum Concentration (C[0h]) of Telaprevir|The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|0 hour (pre-dose) at Day 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."|||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1240187|NCT00580801|Secondary|Maximum Serum Concentration (Cmax) of Telaprevir|The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."|||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1240188|NCT00580801|Secondary|Area Under the Serum Concentration-Time Curve (AUC)|The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"Intent-to-treat (ITT) population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."|||nanogram*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
1240189|NCT00580801|Secondary|Percentage of Participants With Relapse|Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.|Week 24 after EOT (Week 48/50 or early discontinuation)|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. N signifies those participants who were evaluated for this measure."|||Percentage of participants|||Number
1240190|NCT00580801|Secondary|Percentage of Participants With Sustained Viral Response (SVR)|Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.|Week 12 and 24 after the last dose of study medication|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.|||Percentage of participants|||Number
1240191|NCT00580801|Secondary|Number of Participants With Viral Breakthrough (Detectable HCV RNA)|Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.|Day 8, Day 12, Day 15, Week 24/26 and Week 36/38|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.|||Participants|||Number
1240192|NCT00580801|Secondary|Median Time to First Viral Response (Undetectable HCV RNA)|Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.|Up to Week 48/50|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.|||Days||95% Confidence Interval|Median
1240193|NCT00580801|Secondary|Percentage of Participants With Viral Response (Undetectable HCV RNA)|Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants’ plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.|Day 15 up to EOT (Week 48/50 or early discontinuation)|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Percentage of participants|||Number
1240194|NCT00580801|Primary|Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15|The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.|Baseline and Day 15|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||log 10 IU/mL||Full Range|Median
1240195|NCT00580788|Secondary|Fractional Excretion of Calcium|% calculated from daily second morning void|daily||||% of filtered load||Standard Error|Mean
1240196|NCT00580788|Secondary|Parathyroid Hormone (1-84)|pg/ml|Baseline and Daily||||pg/ml||Standard Error|Mean
1240197|NCT00580788|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|% change from baseline|Baseline, Daily, and 1 week follow-up||||% change||Standard Error|Mean
1240198|NCT00580788|Secondary|Amino-terminal Peptides of Procollagen 1 (P1NP)|% change from baseline|Baseline, Daily, and 1 week follow-up||||% change||Standard Error|Mean
1240199|NCT00580788|Secondary|Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)|% change from baseline|Baseline, Daily, and 1 week follow-up||||% change||Standard Error|Mean
1240200|NCT00580788|Secondary|Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)|% change from baseline|Baseline, Daily, and 1 week follow-up||||% change||Standard Error|Mean
1240201|NCT00580788|Primary|Serum Phosphorous|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
1240202|NCT00580788|Primary|Ionized Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
1240203|NCT00580788|Primary|Total Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
1240204|NCT00580788|Secondary|Tubular Maximum of Phosphorous (TmP/GFR)|mg/dl calculated from daily second morning void|daily||||mg/dl||Standard Error|Mean
1240205|NCT00580788|Secondary|24 Hour Urine Calcium|mg/gm creatinine collected on day 7 of PTHrP infusion|24 hours||||mg/gm creatinine||Standard Error|Mean
1240206|NCT00580788|Secondary|1,25 Vitamin D|pg/ml|Baseline and Daily through day 8 then at follow-up visit||||pg/ml||Standard Error|Mean
1240207|NCT00580788|Primary|Dose Limiting Toxicity (DLT)|DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall >30 mm/hg), tachycardia (pulse > 120), hypertension (systolic BP >160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous < 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.|12 hours after the infusion was started then q 8 hours for 7 days||||participants|||Number
1240208|NCT00580723|Primary|Telangiectasia Severity|Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean telangiectasia severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.|||Telangiectasia percent improvement||Standard Deviation|Mean
1240209|NCT00580723|Primary|Inflammatory Lesion Count|Lesion counts were numerically summed for each patient at each encounter, and the average lesion count was calculated from all continuing 16 subjects at each visit, for a total of 8 visits. Percent improvement (reduction in lesion number) was assessed by comparing the average number of lesions at week 48 to the average number of lesions assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.|||Percent change in number of lesions||Standard Deviation|Mean
1240214|NCT00580723|Primary|Erythema Severity|Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean erythema severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.|||Erythema percent improvement||Standard Deviation|Mean
1240215|NCT00580671|Primary|Marijuana Abstinence (4 Weeks or Greater)|Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.|Twice weekly urine tests for 14 weeks.||||percentage of participants|||Number
1240216|NCT00580671|Secondary|Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks)|This reflects the mean proportion of days of marijuana abstinence for each participant|This is for the proportion of days abstinent across the entire 14-week treatment period. Self-report data are collected twice weekly during treatment to obtain a cumulative proportion|Those participants with data on at least 80 days of the 91 days of treatment were used in this analysis.|||proportion of marijuana abstinent days||Standard Deviation|Mean
1240217|NCT00580671|Primary|Marijuana Abstinence (2 Weeks or Greater)|Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.|Testing done twice weekly for 14 weeks.||||percentage of participants|||Number
1240218|NCT00580645|Secondary|Alcohol Craving|alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)|during laboratory session (Day 8) at baseline|n=19 in the 2mg/day varenicline group because 1 subject failed to respond on measure.|||units on a visual analog scale||Standard Error|Mean
1240219|NCT00580645|Primary|Number of Drinks Consumed|number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session|2 hour ad-lib drinking period, during the laboratory session (Day 8)|number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session|||number of drinks||Standard Error|Mean
1240220|NCT00580606|Secondary|Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.|Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy|All subjects randomized to the Low Dose Peanut SLIT group and all subjects randomized to the Placebo group who crossed over to open label high dose peanut sublingual immunotherapy were included.|||percentage of participants|||Number
1240221|NCT00580606|Secondary|Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption|All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.|Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption|All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.|||participants|||Number
1240222|NCT00580606|Secondary|Number of Participants With Serious Adverse Events (SAEs)|This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.|Baseline through Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||participants|||Number
1240223|NCT00580606|Secondary|Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg|During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.|Week 44 after initiating crossover open label peanut protein consumption|All subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included.|||Percentage of participants|||Number
1240224|NCT00580606|Secondary|Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.|Week 44 after initiating crossover open label peanut protein consumption|Subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included except for 1 subject who refused the crossover Week 44 OFC and could not be evaluated. 4 subjects who discontinued dosing prior to the crossover Week 44 OFC were counted as failures.|||Percentage of participants|||Number
1240225|NCT00580606|Secondary|Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg|During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.|Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||Percentage of participants|||Number
1240228|NCT00580502|Secondary|Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of Triglycerides from baseline at 5 years|5 years|All participants who underwent LAGB and had 5 year follow up visit are included in the analysis population.|||mg/dl||Standard Deviation|Mean
1240229|NCT00580502|Secondary|Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of LDL from baseline at 5 years|5 years|All participants who underwent LAGB are included in the analysis population.|||mg/dl||Standard Deviation|Mean
1240231|NCT00580398|Secondary|Biochemically-validated 7-day Point Prevalence Tobacco Abstinence|7-day point prevalence abstinence (“Have you smoked a cigarette, even a puff, in the past 7 days?”) was assessed at 12-week follow-up. Self reported abstinence was confirmed only if a salivary cotinine level was < 15 ng/ml or an expired carbon monoxide measurement was <10 ppm.|12 weeks|46 participants (32 intervention, 14 control) returned a cotinine confirmation kit for biochemical validation of 7 day point prevalent tobacco abstinence at 12 weeks. 3 control participants were excluded from the follow-up analysis.|||participants|||Number
1240232|NCT00580398|Primary|Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.|Number of participants who completed the 12-week follow-up survey and thus the study.|12 weeks||||participants|||Number
1240233|NCT00580372|Primary|Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy|"Relapse is defined by the unequivocal objective evidence of recurrent disease such as:~myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis >10% or >5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for >2 months."|5 years||||percentage of participants|||Number
1240234|NCT00580333|Secondary|Patients With Miller-Payne (MP) Score 3, 4, or 5 Response|To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response).|2 years||||percentage of participants||95% Confidence Interval|Number
1240235|NCT00580333|Secondary|Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy.|Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons.|2 years|analyzed the 43 patients who completed 4 cycles of neoadjuvant therapy and started post-operative treatment|||Participants|||Count of Participants
1240236|NCT00580333|Secondary|Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||Participants|||Count of Participants
1240237|NCT00580333|Primary|Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.|The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.|2 years||||percentage of participants||95% Confidence Interval|Number
1240238|NCT00580294|Primary|Brief Pain Inventory||Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment|||||||
1240239|NCT00580294|Primary|Change in Patient Global Impression of Change|PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)|baseline and 12 hours||||units on a scale||95% Confidence Interval|Mean
1240240|NCT00580229|Secondary|Adverse Events Assessed From Day 15 Through Week 26.|All adverse events reported from day 15 (24 hours after second infusion) through week 26.|24 weeks||||events|||Number
1240241|NCT00580229|Secondary|Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion.|Assessment of all adverse infusion reactions within 24 hours of receipt of the second rituximab infusion|24 hours||||acute infusion reactions|||Number
1240242|NCT00580229|Primary|Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion|Open-label assessment of AIR's during and/or within 24 hours in patients pretreated with 40mg oral prednisone 30 minutes prior to initial rituximab infusion|24 hours|The subjects were 18-80 years of age, and fulfilled the 1987 American College of Rheumatology Criteria for Rheumatoid Arthritis, and taking concomitant methotrexate.|||acute infusion reactions|||Number
1240243|NCT00580151|Secondary|Anxiety Reduction|"The Fear Thermometer measures how much fear subject is currently having. (0=None, 1= A little bit, 2= Some, 3= A lot, 4= Very, very much). The average of daily Value for 10 days."|Average of the 10 days|Patients analyzed were all patients consented.|||units on a scale||Full Range|Mean
1240244|NCT00580151|Primary|Pain Reduction|"The scale name is FACES (Faces Pain Rating Scale). Subjects were asked rate your WORST PAIN today (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged."|Average of the 10 days|Determined by the number of patients recruited.|||units on a scale||Full Range|Mean
1240245|NCT00580138|Primary|Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing.|Percentages were calculated for agreement between ratings made by on site clinician and clinician off site with telemedicine.|2 years||||percent agreement|||Number
1240246|NCT00580073|Secondary|Overall Survival|Overall survival is defined as the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date of follow-up.|Up to 3 years|This study was closed because of withdrawal of funding. All participants were off study on 02/03/2011.||||||
1240247|NCT00580073|Secondary|Progression Free Survival|Number of participants who achieve progression free survival, defined as the time from date of registration to date of disease progression, up through study closure. Progressive disease is defined as ≥ 20% increase in the sum of the longest dimensions of the primary lesion taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.|Up to 3 years||||participants|||Number
1240248|NCT00580073|Primary|Down-staging of the Tumor; Response to Therapy|Down-staging of the tumor and tumor response rate is defined as the proportion of participant who have any evidence of complete response (CR), pathologic complete response (pCR), or partial response (PR).|6 months||||participants|||Number
1240250|NCT00580047|Primary|Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant|Percentage Change in Posterior Anterior (PA) spine bone density from baseline to 24 months post transplant|24 months|Percentage change in spine bone density from baseline to 24 months|||percentage of change of bone density|||Number
1240251|NCT00580034|Secondary|Response|Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR). CR for malignant hematologic diseases is met if all the following are met for >/= 1 month: a) absence of pathologic lymphadenopathy by physical and radiographic exam b) absence of constitutional symptoms due to disease c) Polymorphonuclear leukocyte count >1,500/uL; platelet count >50,000/uL; and hemoglobin >10.0 g/dL d) bone marrow aspirate/biopsy done after (a) through (c) have been met, >/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc. e) molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc. CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values.|2 years|Cohort of subjects on the study who actually received >/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have >grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion.|||months||Full Range|Mean
1240252|NCT00580034|Primary|Overall Survival (OS)|Estimate toxicity and overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.|8 years|Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death.|||months||Full Range|Mean
1240253|NCT00580034|Primary|Toxicity|Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.|1 year|Cohort of subjects on the study who received >/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.|||participants|||Number
1240254|NCT00579982|Secondary|Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation|Tablet Routine Questionnaire (Adherence): Adherence to the treatment was evaluated by asking if the participant would be more likely to take the ODT formulation (yes/no)|End of Study (Week 3) or at Early Withdrawal|ITT: Only 94 of the 97 subjects in the ITT Population responded to the Tablet Routine Questionnaire.|||Number of participants|||Number
1240255|NCT00579982|Secondary|Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3|Companion/Caregiver indicates whether ODT is more convenient or standard IR tablet is more convenient|End of Study (Week 3) or at Early Withdrawal|ITT|||Number of participants|||Number
1240256|NCT00579982|Secondary|Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3|Participant indicated whether preference was for ODT or the standard IR tablet|End of Study (Week 3) or at Early Withdrawal|ITT|||Number of participants|||Number
1240257|NCT00579982|Secondary|"Number of Participants Answering the Question Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet? at Week 3"|Organoleptic Questionnaire, question 9: Compared to standard tablets that need to be swallowed with liquid, how easy or difficult is it to use this orally disintegrating tablet? [from a rating of 1 (Extremely difficult) to 5 (Extremely easy)]|End of Study (Week 3) or at Early Withdrawal|ITT|||Number of participants|||Number
1240258|NCT00579982|Secondary|"Number of Participants Answering the Question Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet? at Week 3"|Organoleptic Questionnaire, question 8: Compared to standard tablets that need to be swallowed with liquid, how convenient or inconvenient did you find this orally disintegrating tablet? (from a rating of 1 [Extremely inconvenient] to 5 [Extremely convenient])|End of Study (Week 3) or at Early Withdrawal|ITT|||Number of participants|||Number
1240259|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied Were You With the Aftertaste of the Tablet? at Week 3"|Organoleptic Questionnaire, question 7: How satisfied were you with the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely dissatisfied) to 6 (I did NOT experience an aftertaste)]|Baseline, End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
1240260|NCT00579982|Secondary|"Number of Participants Answering the Question How Would You Rate the Aftertaste of the Tablet? at Week 3."|Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)]|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
1240261|NCT00579982|Secondary|"Number of Participants Answering the Question How Would You Rate the Strength of the Flavor of the Tablet? at Week 3"|Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? [from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)]|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
1240262|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied Were You With the Flavor of the Tablet? at Week 3"|Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
1240263|NCT00579982|Secondary|Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3|Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? [from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)]|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
1240264|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve at Week 3"|Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]|Baseline, End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
1240265|NCT00579982|Secondary|"Number of Participants Answering the Question Did the Tablets Dissolve Instantly (Yes or no)? at Week 3"|The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)?|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
1240266|NCT00579982|Secondary|Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3|Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation.|Baseline, End of Study (Week 3 weeks) or at Early Withdrawal|ITT|||Points on a scale||Standard Deviation|Mean
1240267|NCT00579982|Secondary|Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3|Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).|Baseline, End of Study (Week 3) or at Early Withdrawal|ITT|||Points on a scale||Standard Deviation|Mean
1240268|NCT00579982|Secondary|Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3|The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100.|Baseline, End of Study (Week 3) or Early Withdrawal|ITT|||Points on a subscale||Standard Deviation|Mean
1240269|NCT00579982|Primary|Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.|The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.|Baseline, End of Study (Week 3) or Early Withdrawal|Intent to Treat (ITT). Ninety-eight participants were enrolled in the study, but one withdrew prior to receiving lamotrigine ODT treatment. All efficacy and safety analyses are based on the Intent to Treat population, which includes the 97 patients who received at least one dose of ODT treatment.|||Points on a subscale||Standard Deviation|Mean
1240270|NCT00579826|Secondary|Change in Biomarkers Associated With Bone and Cardiovascular Health, Adverse Events, Breast Cancer Prevention Trial (BCPT) Symptom Check List, Hot Flash Score, General Fatigue Inventory, the Fibromyalgia Impact Questionnaire.||6 Months, 12 Months||2018-04-30|04/2018||||
1240271|NCT00579826|Secondary|Change in Mammographic Density From Baseline to 6 Months..|Percent area of the breast considered to be at increased density, as determined by the computer program Cumulus..|Baseline to 6 Months|Subjects who complete the initial 6-months intervention and have mammograms available for analysis at baseline and 6 months, thus a change can be computed.|||percentage of breast at high densit||Standard Deviation|Mean
1240272|NCT00579826|Secondary|Assessment of Change in Morphology by the Masood Score.|Masood score is a semi-quantitative index of increasing abnormality, thus higher values are worse. Range 6 to 24.|Baseline to 6 Months|Subjects who complete initial 6-month intervention and have a repeat RPFNA, thus a change from baseline to 6-months can be computed.|||units on a scale||Standard Deviation|Mean
1240273|NCT00579826|Primary|Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months|Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration from women at high risk for the development of breast cancer.|Baseline to 6 Months|Subjects who complete initial 6-month period and have repeat RPFNA.|||percentage of cells stained positive||Standard Deviation|Mean
1240274|NCT00579813|Primary|Changes in Fat Inflammation Following Pioglitazone|macrophages in fat at baseline, in lean and obese participants, and obese after pioglitazone (in obese)|Baseline and 10 weeks||||macrophages per mm2 by CD68 staining||Standard Deviation|Mean
1240275|NCT00579813|Primary|Changes in Muscle Lipid After Pioglitazone|Muscle lipid following biopsy using oil red-O staining.|At baseline and 10 weeks||||arbitrary units of oil red O staining||Standard Deviation|Mean
1240276|NCT00579813|Primary|Effects of Pioglitazone on Changes in BMI|Body Mass Index (BMI) is measured at baseline, in lean and obese subjects, and after pioglitazone in obese subjects|Baseline and 10 weeks||||kg/m2||Standard Deviation|Mean
1240277|NCT00579813|Primary|Change in Insulin Sensitivity Using FSIGT|The frequently sampled intravenous glucose tolerance test (FSIGT) involves the injection of IV glucose and the frequent measurement of glucose and insulin.|Baseline and 10 weeks||||FSIGT units (x10^-4/min/uU/ml)||Standard Deviation|Mean
1240278|NCT00579670|Post-Hoc|Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC||Week 12|Within SmPC|||Participants|||Number
1240279|NCT00579670|Post-Hoc|Percent Change From Baseline to Final Visit in Body Weight: Within SmPC||Baseline, Week 12|Within SmPC|||percent change||Standard Deviation|Mean
1240280|NCT00579670|Post-Hoc|"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240281|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240283|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240284|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240285|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240286|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240287|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240288|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240289|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240290|NCT00579670|Post-Hoc|"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participant|||Number
1240291|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240292|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240293|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
1240294|NCT00579670|Post-Hoc|PANSS - Composite Subscale: Within SmPC|The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation|||Scores on a scale||Standard Deviation|Mean
1240295|NCT00579670|Post-Hoc|PANSS - Negative Subscale: Within SmPC|Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation|||Scores on a scale||Standard Deviation|Mean
1240296|NCT00579670|Post-Hoc|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC|Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation|||Scores on a scale||Standard Deviation|Mean
1240297|NCT00579670|Post-Hoc|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)|Baseline, Week 12|Within SmPC|||Participants|||Number
1240298|NCT00579670|Post-Hoc|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)|CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|Within SmPC population: participants in FAS population who received all doses within SmPC. Within SmPC defined as all PO doses up to and including 160 mg per day and all IM doses up to and including 40 mg per day.|||Participants|||Number
1240299|NCT00579670|Secondary|Percent Change From Baseline to Final Visit in Body Weight||Baseline, Week 12|Safety population = all subjects who received at least 1 dose of study medication.|||percent change||Standard Deviation|Mean
1240300|NCT00579670|Other Pre-specified|Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period||Week 12|FAS. Four subjects did not answer the question of continuation of treatment.|||Participants|||Number
1240301|NCT00579670|Secondary|"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"||Week 12|FAS|||Participants|||Number
1240308|NCT00579670|Secondary|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"||Week 12|FAS|||Participants|||Number
1240309|NCT00579670|Secondary|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"||Week 12|FAS|||Participants|||Number
1240310|NCT00579670|Secondary|"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"||Week 12||||Participants|||Number
1240311|NCT00579670|Secondary|"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?"||Week 12||||Participant|||Number
1240312|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"||Week 12|FAS|||Participants|||Number
1240313|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"||Week 12||||Participants|||Number
1240314|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"||Week 12|FAS|||Participants|||Number
1240315|NCT00579670|Secondary|PANSS - Composite Subscale|The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.|Baseline, Week 12|FAS|||Scores on a scale||Standard Deviation|Mean
1240316|NCT00579670|Secondary|PANSS - Negative Subscale|Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.|Baseline, Week 12|FAS|||Scores on a scale||Standard Deviation|Mean
1240317|NCT00579670|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.|Baseline, Week 12|FAS|||Scores on a scale||Standard Deviation|Mean
1240318|NCT00579670|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)|Baseline, Week 12|FAS; Baseline Visit: 1 subject in the Ziprasidone >=160mg group had missing severity result. Final Visit: 2 subjects (1 subject in the Ziprasidone 120mg to <160mg and 1 subject in the Ziprasidone <80mg group) had missing severity results.|||Participants|||Number
1240319|NCT00579670|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|The Full Analysis Set (FAS) - all subjects who received at least 1 dose of study medication and have at least 1 efficacy measurement.|||Participants|||Number
1240320|NCT00579670|Primary|Summary of Most Frequently Used Concomitant Drug Treatments|Most frequently concomitant drug treatments used by >15 participants.|Baseline|All subjects randomized to a treatment group were included in this baseline analysis.|||Participants|||Number
1240321|NCT00579670|Primary|Summary of Metabolic Risk Factors||Baseline|All subjects randomized to a treatment group were included in this baseline analysis.|||Participants|||Number
1240322|NCT00579670|Primary|Summary of Schizophrenia|Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.|Baseline|All subjects randomized to a treatment group were included in the Baseline analysis.|||Participants|||Number
1240323|NCT00579501|Secondary|Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)|The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.|Participants who received at least one cycle of trabectedin and have at least one post baseline disease assessment.|||percentage of participants|||Number
1240324|NCT00579501|Primary|Percentage of Participants With Pathological Complete Response (pCR)|Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.|Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.|Participants who received at least one cycle of trabectedin and have adequate pre and post trabectedin pathologic specimens available. Six participants were non evaluable for pCR assessment.|||percentage of participants|||Number
1240325|NCT00579436|Secondary|Insulin Resistance After Fish Oil Regiment|Insulin sensitivity (Si) was measured with a frequently sampled intravenous glucose tolerance test. Participants received a bolus of glucose at Time Zero, then a bolus of insulin 20 minutes later. Blood was collected through an IV catheter at multiple time points over the course of 4 hours. Glucose and Insulin levels will be plotted on a time course curve and analyzed using the MINMOD algorithm.|week 12|all participants measured|||[mU/L]^-1 x [min]^-1]||Standard Error|Mean
1240326|NCT00579436|Secondary|Baseline Insulin Resistance|Insulin sensitivity (Si) was measured with a frequently sampled intravenous glucose tolerance test. Participants received a bolus of glucose at Time Zero, then a bolus of insulin 20 minutes later. Blood was collected through an IV catheter at multiple time points over the course of 4 hours. Glucose levels were plotted on a time course curve and analyzed using the MIDMOD algorithm.|baseline|all participants were analyzed|||[mU/L]^-1 x [min]^-1]||Standard Error|Mean
1240327|NCT00579436|Primary|Adipocyte Size After Fish Oil Treatment|After completing the fish oil regiment, participant will undergo an incisional abdominal biopsy to remove approximately 4g of adipose tissue to determine individual adipocyte size|week 12||||square micrometers||Standard Error|Mean
1240328|NCT00579436|Primary|Baseline Adipocyte Size|Prior to starting the fish oil regiment, participants will undergo an incisional abdominal biopsy to remove approximately 4g of adipose tissue to determine adipocyte size|baseline||||square micrometers||Standard Error|Mean
1240329|NCT00579345|Primary|Immunogenicity Assessment by Geometric Mean Titers (GMT).|Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.|Three weeks postvaccination|Per protocol set: this population consisted of all subjects in the Intention To Treat population (ITT) who had no major protocol violation as defined prior to analysis (ITT=enrolled subjects who received single dose of influenza vaccine(or 2 vaccines if receiving the pneumococcal vaccine) and provided one serum sample before and one after baseline)|||Titers||95% Confidence Interval|Geometric Mean
1240330|NCT00579345|Secondary|Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.|"Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96).~CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is > 2.5."|Three weeks postvaccination|Per Protocol|||Ratio||95% Confidence Interval|Geometric Mean
1240331|NCT00579345|Secondary|Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.|"Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96).~Seroconversion was defined as negative pre-vaccination titer (<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10)."|Three weeks postvaccination|Per Protocol Set|||Subjects|||Number
1240332|NCT00579345|Primary|Number of Randomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.|One week postvaccination|Safety set: this population consisted of all subjects who were vaccinated and who had some post-baseline safety data.|||Subjects|||Number
1240333|NCT00579345|Secondary|Number of Randomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site.|One week postvaccination|Safety Set|||Subjects|||Number
1240334|NCT00579345|Secondary|Number of Unrandomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.|One week postvaccination|Safety set.|||Subjects|||Number
1240335|NCT00579254|Primary|Change in Systolic and Diastolic Blood Pressure|No efficacy results were available from this terminated study.|Baseline, 24 weeks||||mmHg (millimeters of mercury)||Standard Deviation|Mean
1240336|NCT00579137|Secondary|Number of Patients With Grade III to IV Acute GVHD||100 days||||participants|||Number
1240337|NCT00579137|Secondary|Number of Patients With Grade III or IV Toxicity||100 days||||participants|||Number
1240338|NCT00579137|Secondary|Patients Alive at 1 Year||1 Year||||participants|||Number
1240339|NCT00579137|Primary|Number of Patients With Donor Engraftment||100 Days||||participants|||Number
1240340|NCT00579111|Secondary|Number of Patients With Treatment Related Grade III or IV Non-hematological Toxicity||100 days||||participants|||Number
1240341|NCT00579111|Primary|Number of Patients With Successful Donor Engraftment|Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant.|100 days||||participants|||Number
1240342|NCT00579098|Secondary|Change in Lipid Levels|The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated.|Baseline and 3 months|Intent-to-treat analysis population.|||mg/dL||Standard Deviation|Mean
1240343|NCT00579098|Secondary|Change in Mean Quality of Life Score|A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group.|Baseline and 3 months|Intent-to-treat analysis population.|||units on a scale||Standard Deviation|Mean
1240344|NCT00579098|Secondary|Change in Mean C-Reactive Protein Level||Baseline and 3 months|Intent-to-treat analysis population.|||mg/dL||Standard Deviation|Mean
1240345|NCT00579098|Secondary|Percentage of Subjects Without Atrial Arrhythmia at 3 Months|Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter.|Baseline through 3 months|Intent-to-treat analysis population.|||Percentage of subjects|||Number
1240346|NCT00579098|Primary|Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months|Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group).|Baseline through 3 months|Intent-to-treat analysis population.|||Percentage of subjects|||Number
1240347|NCT00579059|Secondary|Range of Motion - Flexion|This represents how far the patients were able to flex the knee in the clinic at 1-year.|1 Year|This population represents patients that returned for follow-up at 1-year post-op per protocol.|||degrees||Full Range|Mean
1240348|NCT00579059|Primary|Knee Society Function Score|"The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent, 60-89 is considered Good, 30-59 is considered fair, and 0-29 is considered poor."|1 Year|This population represents patients that returned for follow-up at 1-year post-op per protocol.|||knees|||Number
1240349|NCT00578968|Secondary|Percent Change in Peak Exercise HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.|||percentage of change in HR||Standard Deviation|Mean
1240350|NCT00578968|Secondary|Percent Change in Peak Exercise SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.|||percentage of change in SVI||Standard Deviation|Mean
1240351|NCT00578968|Primary|Pretreatment Peak Exercise SVI|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||mL/m^2||Standard Deviation|Mean
1240352|NCT00578968|Secondary|Percent Change in Peak Exercise CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.|||percentage of change in CI||Standard Deviation|Mean
1240353|NCT00578968|Primary|Pretreatment Peak Exercise CI|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||L/min/m^2||Standard Deviation|Mean
1240354|NCT00578968|Secondary|Percent Change in Peak Exercise VO_2 Between Pretreatment in First Study Period and Post-treatment in Second Study Period|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal Control population did not take part in this measurement.|||percentage of change in VO_2||Standard Deviation|Mean
1240355|NCT00578968|Secondary|Pretreatment Peak Exercise Maximal Oxygen Consumption (VO_2)|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||L/min||Standard Deviation|Mean
1240356|NCT00578968|Secondary|Percent Change in Resting HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.|||Percentage of change in HR||Standard Deviation|Mean
1240357|NCT00578968|Secondary|Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||bpm||Standard Deviation|Mean
1240358|NCT00578968|Secondary|Percent Change in Resting SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.|||Percentage of change in SVI||Standard Deviation|Mean
1240390|NCT00578864|Secondary|Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.|The first of the two events (relapse or death) was chosen to represent disease free survival|3 years||||participants|||Number
1240359|NCT00578968|Secondary|Pretreatment Resting SVI|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||mL/m^2||Standard Deviation|Mean
1240360|NCT00578968|Secondary|Percent Change in Resting CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.|||percentage of change in CI||Standard Deviation|Mean
1240361|NCT00578968|Secondary|Pretreatment Resting CI|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||L/min/m^2||Standard Deviation|Mean
1240362|NCT00578968|Secondary|Percent Change in Resting FEV_1 Between Pretreatment in First Study Period and Post-treatment in Second Study Period|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.|||Percentage of change in FEV_1||Standard Deviation|Mean
1240363|NCT00578968|Secondary|Pretreatment Resting FEV_1|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||L/sec||Standard Deviation|Mean
1240364|NCT00578968|Secondary|Percent Change in Resting FVC Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal Control population did not take part in this measurement.|||percentage of change in FVC||Standard Deviation|Mean
1240365|NCT00578968|Secondary|Pretreatment Resting FVC as Percentage of Predicted FVC|Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.|First visit of first period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||percentage of predicted FVC||Standard Deviation|Mean
1240366|NCT00578968|Primary|Baseline Resting Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).|first visit of first study period||||mL/m^2||Standard Deviation|Mean
1240367|NCT00578968|Primary|Baseline Resting Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|First visit of first study period||||L/min/m^2||Standard Deviation|Mean
1240368|NCT00578968|Secondary|Pretreatment Resting Forced Vital Capacity (FVC)|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.|First study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||Liters||Standard Deviation|Mean
1240369|NCT00578968|Secondary|Baseline Peak Exercise Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|second visit of first study period||||mL/m^2||Standard Deviation|Mean
1240370|NCT00578968|Secondary|Baseline Peak Exercise Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|second visit of first study period||||L/min/m^2||Standard Deviation|Mean
1240371|NCT00578968|Secondary|Baseline Peak Exercise Maximal Oxygen Consumption (VO_2)|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.|second visit of first study period||||L/min||Standard Deviation|Mean
1240372|NCT00578968|Secondary|Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.|first visit of first study period, second visit of first study period||||beats per minute (bpm)||Standard Deviation|Mean
1240373|NCT00578968|Secondary|Baseline Resting FEV_1 as Percentage of Predicted FEV_1|Predicted normal values for Forced Expiratory Volume in 1 second can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FEV_1/predicted FEV_1 X 100.|first visit of first study period||||percentage of predicted FEV_1||Standard Deviation|Mean
1240374|NCT00578968|Secondary|Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1)|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.|first visit of first study period||||L/sec||Standard Deviation|Mean
1240375|NCT00578968|Secondary|Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC)|Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.|First visit of first study period||||percentage of predicted FVC||Standard Deviation|Mean
1240376|NCT00578968|Secondary|Baseline Resting Forced Vital Capacity (FVC)|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.|First visit of first study period|All COPD participants were included, prior to randomization in the second period of the study.|||Liters||Standard Deviation|Mean
1240377|NCT00578942|Secondary|Response|"Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR).~CR for malignant hematologic diseases is met if all the following are met for >/= 1 month:~absence of pathologic lymphadenopathy by physical and radiographic exam~absence of constitutional symptoms due to disease~Polymorphonuclear leukocyte count > 1,500/uL; platelet count >50,000/uL; and hemoglobin >10.0 g/dL~bone marrow aspirate/biopsy done after (a) through (c) have been met, >/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc.~molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc.~CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values."|1 year|Cohort of subjects on the study who actually received >/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have >grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion.|||participants|||Number
1240378|NCT00578942|Primary|Overall Survival (OS)|Estimate overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.|Up to 12 years; participants were followed for the duration of the study, an average of 8 years|Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death. One participant who was lost to follow-up after 14 months was not included. Participants were followed for the duration of the study, an average of 8 years.|||months alive post-infusion||Full Range|Mean
1240379|NCT00578942|Primary|Toxicity|Acute graft versus host disease (GVHD) was graded according to the consensus criteria and NCI common terminology criteria for adverse events (CTCAE) v2.0 or 3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the nonablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.|1 year|Cohort of subjects who received >/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg.Subjects were grouped into 4 categories within the range of cell doses delivered and were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.|||participants|||Number
1240380|NCT00578929|Secondary|Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)|"Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score.~The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days."|Baseline through 2 weeks after randomization||||Percent change of TOSS from baseline||Standard Error|Least Squares Mean
1240381|NCT00578929|Primary|Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)|"Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score.~The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days."|Baseline through 2 weeks after randomization||||Percent change of TNSS from baseline||Standard Error|Least Squares Mean
1240382|NCT00578903|Secondary|Number of Subjects Alive at 2 Years Post Transplant||2 years||||participants|||Number
1240383|NCT00578903|Secondary|Number of Subjects Alive at 1 Year Post Transplant||1 year||||participants|||Number
1240384|NCT00578903|Secondary|Number of Patients With Chronic GVHD at 2 Years Post Transplant||2 years||||participants|||Number
1240385|NCT00578903|Secondary|Number of Patients With Acute GVHD at 100 Days Post Transplant||100 days||||participants|||Number
1240386|NCT00578903|Secondary|Number of Patients With Engraftment Rate at 100 Days Post Transplant|Absolute neutrophil count greater than 0.5 X 10^9/ml for at least 3 days|100 days post transplant||||participants|||Number
1240387|NCT00578903|Primary|Number of Subjects Alive at 100 Days Post Transplant||100 days||||participants|||Number
1240388|NCT00578877|Secondary|Percent Women With Urogenital Adverse Events.|Clinically evaluate the safety of the SILCS diaphragm used with contraceptive gel over 6 months of use.|6 months|||||||
1240389|NCT00578877|Primary|Percent Probability of Pregnancy Among Users of the SILCS Diaphragm Used With Contraceptive Gel Over 6 Months of Typical Use||6 months||||percent probability|||Number
1240391|NCT00578864|Secondary|Percentage of Patients Who Have Surgery After the Second Cycle of Induction Therapy|the measure is the number of patients who have surgery after two cycles of induction|2 months||||participants|||Number
1240392|NCT00578864|Secondary|Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.||3 years|number of survival|||participants|||Number
1240393|NCT00578864|Primary|Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.|If a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC > 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia|2 months||||participants|||Number
1240394|NCT00578864|Primary|Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.||2 months||||participants|||Number
1240395|NCT00578812|Secondary|Flexion/Extension Range of Motion at the Operative Level|Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.|24 Months|Per Protocol|||degrees||Standard Deviation|Mean
1240396|NCT00578812|Secondary|Nurick's Classification of Disability (Myelopathy)|Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick’s classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient “maintained” if their Nurick classification grade remained the same or “improved” if it decreased from baseline to 24 months.|24 Months|Per protocol with extended windows|||participants|||Number
1240397|NCT00578812|Secondary|Patient Satisfaction|Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).|24 Months|Per protocol|||mm||Standard Deviation|Mean
1240398|NCT00578812|Secondary|Dysphagia for Swallowing|Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).|24 Months|Per protocol|||mm||Standard Deviation|Mean
1240399|NCT00578812|Secondary|Mean SF-36 Mental Component Summary (MCS)|Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).|24 Months|Per Protocol|||units on a scale||Standard Deviation|Mean
1240400|NCT00578812|Secondary|Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)|Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.|24 Months|Per Protocol|||participants|||Number
1240401|NCT00578812|Secondary|Mean SF-36 Physical Component Summary (PCS)|Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).|24 Months|Per protocol|||units on a scale||Standard Deviation|Mean
1240402|NCT00578812|Secondary|Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)|Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.|24 Months|Per protocol|||participants|||Number
1240403|NCT00578812|Secondary|Mean Neck Disability Index (NDI)|Mean NDI at 24 months on a 0-100 scale (lower value is better).|24 Months|Per protocol|||units on a scale||Standard Deviation|Mean
1240404|NCT00578812|Secondary|Clinically Significant Improvement on Neck Disability Index (NDI)|Improvement in NDI of ≥15-points at 24 months compared to baseline.|24 Months|Per protocol|||participants|||Number
1240405|NCT00578812|Secondary|Clinically Significant Improvement on Neck Disability Index (NDI)|Improvement in NDI of ≥20% at 24 months compared to baseline.|24 Months|Per protocol|||participants|||Number
1240406|NCT00578812|Secondary|Mean Worst Arm Pain Visual Analog Scale|Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).|24 Months|Per protocol|||mm||Standard Deviation|Mean
1240407|NCT00578812|Secondary|Worst Arm Pain Visual Analog Scale|Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.|24 Months|Per protocol|||participants|||Number
1240408|NCT00578812|Secondary|Mean Neck Pain Visual Analog Scale|Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).|24 Months|per protocol|||mm||Standard Deviation|Mean
1240409|NCT00578812|Secondary|Neck Pain Visual Analog Scale|Improvement of ≥20mm in neck pain at 24 months compared to baseline.|24 Months|per protocol|||participants|||Number
1240410|NCT00578812|Primary|Individual Patient Overall Success|Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.|24 Months|Per Protocol|||participants|||Number
1240411|NCT00578786|Primary|Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN)|The number of participants with serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) falling into the following categories: >3.0 and </= 5.0 x ULN, >5.0 and </= 8.0 x ULN, and >8.0 x ULN. Includes the highest value per participant across all visits as well as values from early termination visits.|Baseline to Week 295|Safety Analysis Set: Includes all participants who received at least 1 blinded dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||participants|||Number
1240412|NCT00578786|Secondary|Long-term Survival|Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.|Baseline to Year 4|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||percent probability (KM estimate)||95% Confidence Interval|Number
1240519|NCT00578214|Secondary|Blood Pressure at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.|||mm Hg||Standard Deviation|Mean
1240413|NCT00578786|Secondary|Percentage of Participants With Failure-Free Treatment Status|Treatment failure was defined as the time from randomization to ambrisentan therapy to the first occurrence of death, lung transplantation, addition of approved prostanoid therapy, study withdrawal due to the addition of other clinically approved PAH therapeutics, or study withdrawal due to 2 or more early escape criteria (for subjects randomized to ambrisentan in NCT00423748 or NCT00423202). Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.|Baseline to Year 4|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||percent probability (KM estimate)||95% Confidence Interval|Number
1240414|NCT00578786|Secondary|Percentage of Participants With No Clinical Worsening of PAH|Clinical worsening of PAH was defined as the time from randomization to ambrisentan therapy to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, addition of approved prostanoid therapy, study withdrawal due to the addition of other clinically approved PAH therapeutics, or study withdrawal due to 2 or more early escape criteria (for subjects randomized to AMB in NCT00423748 or NCT00423202). Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||percent probability (KM estimate)||95% Confidence Interval|Number
1240415|NCT00578786|Secondary|Change From Baseline to Week 36 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 36|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.|||units on a scale||Standard Deviation|Mean
1240416|NCT00578786|Secondary|Change From Baseline to Week 24 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 24|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.|||units on a scale||Standard Deviation|Mean
1240417|NCT00578786|Secondary|Change From Baseline to Week 12 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 12|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.|||units on a scale||Standard Deviation|Mean
1240418|NCT00578786|Secondary|Baseline SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.|||units on a scale||Standard Deviation|Mean
1240419|NCT00578786|Secondary|Change From Baseline to Year 3 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. Missing values were imputed using LOCF based on post-baseline observations.|||participants|||Number
1240420|NCT00578786|Secondary|Change From Baseline to Year 2 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values were imputed using LOCF based on post-baseline observations.|||participants|||Number
1240874|NCT00576420|Secondary|Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||x10^3/µl||Full Range|Median
1240421|NCT00578786|Secondary|Change From Baseline to Year 1 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 1|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values imputed using LOCF based on post-baseline observations.|||participants|||Number
1240422|NCT00578786|Secondary|Baseline World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||participants|||Number
1240423|NCT00578786|Secondary|Change From Baseline to Year 3 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||units on a scale||Standard Deviation|Mean
1240424|NCT00578786|Secondary|Change From Baseline to Year 2 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||units on a scale||Standard Deviation|Mean
1240425|NCT00578786|Secondary|Change From Baseline to Year 1 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 1|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||units on a scale||Standard Deviation|Mean
1240426|NCT00578786|Secondary|Baseline Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||units on a scale||Standard Deviation|Mean
1240427|NCT00578786|Secondary|Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
1240428|NCT00578786|Secondary|Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
1240875|NCT00576420|Secondary|Laboratory Values Over Time: Erythrocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||x10^6/µl||Full Range|Median
1240429|NCT00578786|Secondary|Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Week 48|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
1240430|NCT00578786|Secondary|Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). Missing values were imputed using LOCF method based on post-baseline observations. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Week 24|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
1240431|NCT00578786|Primary|Frequently Reported (15% or More Overall) Adverse Events by Severity|The primary endpoint of this study is the incidence and severity of adverse events associated with long-term exposure to AMB in participants with PAH. The most frequently occurring adverse events (occurring in 15% or more of the participants in the combined group) are presented, by severity, that began after entering this extension study. Adverse events that were serious are included. Adverse events are coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Version 6.1 and are presented by MedDRA preferred term. Severity was graded as follows: mild (AE did not interfere with routine activities; subject may have experienced slight discomfort), moderate (AE interfered with routine activities; subject may have experienced significant discomfort), and severe (AE made it impossible to perform routine activities; subject may have experienced intolerable discomfort or pain).|Baseline to Week 295|Safety Analysis Set: Includes all participants who received at least 1 dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Treatment group assignments for the safety analysis set were based upon the highest dose of AMB received at any time during the parent or extension studies.|||participants|||Number
1240432|NCT00578786|Secondary|Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.).|Baseline|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
1240433|NCT00578734|Secondary|Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days||Up to 14 days|The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.|||days||95% Confidence Interval|Least Squares Mean
1240434|NCT00578734|Primary|Duration of Mechanical Ventilation Through 14 Days|Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.|Up to 14 Days|The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.|||days||95% Confidence Interval|Least Squares Mean
1240435|NCT00578669|Secondary|Self-reported Depressive Symptoms|Self-reported depressive symptoms based on the Center for Epidemiologic Studies-Depression (CES-D) scale. CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms.|One year||||score on a scale||Standard Deviation|Mean
1240436|NCT00578669|Primary|Number of Participants Achieving Smoking Abstinence|7-day point prevalence abstinence|One year||||Participants|||Count of Participants
1240437|NCT00578643|Secondary|Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant.|To estimate the risk for chronic GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors.|Assessed between day 100 and day 365 post transplant|One patient died on day 62 post transplant, and one patient was lost to F/U on day 163 post transplant. They were not assessed for this Outcome Measure.|||Participants|||Count of Participants
1240438|NCT00578643|Secondary|Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant.|To estimate the risk for acute GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors.|Assessed between day 0 and day 100 post transplant|One patient who died on day 62 post transplant without developing acute GVHD was not assessed for this Outcome Measure.|||Participants|||Count of Participants
1240536|NCT00578175|Secondary|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination|Fever was measured rectally.|During the 43-day follow-up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
1240439|NCT00578643|Secondary|Number of Patients That Have Complete Donor Chimerism After Transplant.|To estimate the likelihood of complete donor chimerism for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.|120 days post transplant|One patient died on day 62 post transplant and was not included in the analysis.|||participants|||Number
1240440|NCT00578643|Primary|Percentage of Participants With Engraftment|To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.|28 days post transplant||||percentage of participants|||Number
1240441|NCT00578617|Primary|Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up|Documentation of atrial fibrillation using a cardiac event recorder|12 months after intervention||||participants|||Number
1240442|NCT00578565|Secondary|Percentage of Change in Health Associated Quality of Life From Baseline to 48 Weeks|The percentage change from baseline to week 48 in a participant's perception of the impact of health on his or her quality of life was collected on the Health Assessment Questionnaire (HAQ). The HAQ measures a person's ability to function with arthritis. The questionnaire is divided into 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip and Activities) which include several questions for each category. The category score is determined by the highest score of the set of questions for each category. The disability score is determined by adding the scores for all categories and dividing by 8. The disability scale ranges from 0 (best - without any difficulty) to 3 (worst - unable to do much).|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||percentage of change||Full Range|Mean
1240443|NCT00578565|Primary|Change in Forced Vital Capacity (FVC) From Baseline to 48 Weeks|FVC is one measure of pulmonary function. For FVC, worsening was defined as decrease of at least 10% and improvement was defined as increase of at least 10%.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||participants|||Number
1240444|NCT00578565|Secondary|Change in RA Disease Activity From Baseline to 48 Weeks Using the DAS28 Score.|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.~Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||percentage of change||Full Range|Mean
1240445|NCT00578565|Secondary|Assessment of RA Disease Activity Scores as Measured by the DAS28 Score at Baseline and 48 Weeks|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.~Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||units on a scale||Full Range|Mean
1240446|NCT00578565|Secondary|Change in Lung Fibrosis Score as Observed on High Resolution Computerized Tomography (HRCT) Scans, From Baseline to 48 Weeks|Three serial HRCT scans of each patient were scored independently and simultaneously by two core radiologists, who were blinded to the sequence in which three scans were obtained (at screening, 24 and 48 weeks). The HRCT scoring sheet scored different domains of abnormality such as, linear opacities, consolidation, ground-glass density, etc. Radiographers reported composite impression based on scoring according to worsening, no worsening or improvement of relevant domains.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||participants|||Number
1240447|NCT00578565|Primary|Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks|DLco is one pulmonary function measure. For DLco, worsening was defined as decrease of at least 15% and improvement was defined as increase of at least 15%.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||participants|||Number
1240448|NCT00578552|Primary|Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco|Point prevalence tobacco abstinence was adjudicated if the following conditions were met: (a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question “Have you used any type of tobacco, even a puff, in the past 7 days?” and (b) Expired Carbon Monoxide equal or less then 8 parts per million.|12 weeks following start of medication||||participants|||Number
1240449|NCT00578539|Primary|Median Percentage of Treg Cells at 1 Year Post Transplant|To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol|1 year|Only 13 of the 24 patients enrolled were included in this analysis as only 13 patients have Treg values at 1 year.|||percentage of total CD4+ cells||Inter-Quartile Range|Median
1240450|NCT00578461|Primary|Median Percentage of Treg Cells at 1 Year Post Transplant|The investigative intent is to determine the changes in numbers and function of the regulatory cell population using the best methods to measure this cell population. The frequency of T cells will be summarized at baseline and each time point of follow-up.|1 Year|Only 20 of the 26 patients enrolled were included in this analysis as only 20 patients have Treg values at 1 year.|||percentage of total CD4+ cells||Inter-Quartile Range|Median
1240451|NCT00578448|Secondary|Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants|Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by CTLA-4. Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Kynurenine was measured in micromoles (µM).|Day 1 to Day 364|Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively.|||µM||Standard Deviation|Mean
1240452|NCT00578448|Secondary|Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants|Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by cytotoxic lymphocyte antigen 4 (CTLA-4). Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Tryptophan was measured in micromoles (µM)|Baseline to Day 364|Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively.|||µM||Standard Deviation|Mean
1240453|NCT00578448|Secondary|Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants|Acute rejection of transplant defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. Graft loss was defined as either functional loss or physical loss. Day 1 is day of transplantation.|Day 1 up to 4 years post transplantation|All treated participants were analyzed during the planned 3 year study N=12. Only 9 participants entered the LTE so N=9 for LTE.|||participants|||Number
1240454|NCT00578448|Primary|Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. T-HALF was calculated as ln2/Lz, where Lz is the absolute value of the slope of the terminal log-linear phase. T-HALF is measured in hours (h).|Day 84 to Day 112||||hours||Standard Deviation|Mean
1240455|NCT00578448|Primary|Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. Vss was calculated by dividing the dose by AUC and multiply the mean residence time (MRT). Vss was adjusted to body weight and measured as liter per kilogram body weight (l/kg).|Day 84 to Day 112||||l/kg||Standard Deviation|Mean
1240456|NCT00578448|Primary|Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. CLT was calculated by dividing the dose by AUC(TAU) and was adjusted to body weight. CLT was measured as milliliter per time per kg body weight (mL/h/kg).|Day 84 to Day 112|Participants who were treated and had PK data.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
1240457|NCT00578448|Secondary|Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population|Blood samples were obtained pre and post dose at designated time points up to Day 112 and thereafter, pre-dose samples were obtained at Days 168 and 364, and then once yearly up to end of Year 3. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The trough serum concentration (Cmin), was recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Cmin was measured as micrograms per milliliter (µg/mL).|Day 1 to Day 1092|Number of participants (N) analyzed = 11 for Days 5, 14,and 28; and 12 for Day 56. Days 84, 112, 168, 364 N=10.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1240458|NCT00578448|Primary|Area Under the Concentration Time Curve Within a Dosing Interval (AUC) (TAU) Between Weeks 12 and 16 Following 10 mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). The area under the concentration-time curve in one dose interval [AUC(TAU), where TAU = 4 weeks] were calculated using the mixed log-linear trapezoidal algorithm in Kinetica. Actual sampling times were used for PK calculations. AUC (TAU) was measured as micrograms multiplied by time(h) per milliliter (µg*h/mL).|Day 82 to Day 112||||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1240459|NCT00578448|Primary|Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|Tmax measured in hours (h). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 (h) on Day 112 . The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations.|Day 84 to Day 112|1 participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Tmax, Number of participants analyzed (N)=9.|||hours||Full Range|Median
1240537|NCT00578175|Secondary|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination|Fever was measured rectally.|During the 15-day follow-up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
1240460|NCT00578448|Primary|Maximum Observed Serum Concentration (Cmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept and Trough Serum Concentration Prior to Dosing (Cmin) - Pharmacokinetic Population|Cmax, Cmin are measured in micrograms per milliliter (µg/mL). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. Serum samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The Cmax, and the Cmin were recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Values below lower limits of quantification (LLQ), 0.003 µg/mL, were set to 0.0015 for computation of summary statistics.|Day 84 to Day 112|One participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Cmax, Number of participants analyzed (N)=9.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1240461|NCT00578448|Primary|Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population|Pharmacokinetic (PK) sampling started from pre-dose (0 hour) on Day 84 and ended at 672 hour (h) on Day 112 (between Weeks 12 to 16). The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method and measured as nanograms/milliliter (ng/mL). Less than the lower limit of quantification (LLQ), 3.000 ng/mL concentration value was treated as missing.|Day 84 to Day 112|Number (N) of participants analyzed for each collection time was 10, except for time 0.50 h, which was missing 1 participant. Therefore Number (N) for Time 0.50 h = 9.|||ng/mL||Standard Deviation|Mean
1240462|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240463|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240464|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240465|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240466|NCT00578383|Primary|Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240467|NCT00578383|Primary|Visual Analog Scale (VAS) in Subjects With Bipolar Depression|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240468|NCT00578383|Primary|Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240469|NCT00578383|Primary|Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240470|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.|||units on a scale||Standard Error|Mean
1240471|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.|||units on a scale||Standard Error|Mean
1240472|NCT00578383|Secondary|Visual Analog Scale (VAS): Combined Diagnostic Groups.|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.|||units on a scale||Standard Error|Mean
1240473|NCT00578383|Secondary|Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
1240474|NCT00578331|Secondary|Average Number of Days of Rescue Medication Taken||Month 1 through Month 12|12 patients had missing average use of rescue medication data.|||Days||Standard Deviation|Mean
1240475|NCT00578331|Primary|Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire|Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.|day 30|29 patients had missing mean patient-rated relief assessment data.|||Unit on PRRA scale||Standard Deviation|Mean
1240476|NCT00578318|Primary|Attendance at First Depression Treatment Appointment|Patients were randomized to the intervention or a delayed control group. The primary outcome was bifurcated as yes or no to specify whether or not the patient attended the first available depression treatment appointment scheduled after he/she completed the AAKOMA protocol. The average time to attendance at the first session was approximately 3-4 weeks and during this intermediate time between completion of the protocol and initiation of treatment all patients were followed by study staff).|Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients)||||participants|||Number
1240477|NCT00578305|Secondary|Adverse Events (AEs), Laboratory Parameters, C-reactive Protein, ESR.||Throughout study|||||||
1240478|NCT00578305|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52|The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
1240479|NCT00578305|Secondary|Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures|Correlation coefficients of magnetic resonance imaging erosion, synovitis, and osteitis scores and clinical outcome measures of swollen joint count (SJC), tender joint count (TJC), C-reactive protein level (CRP), erythrocyte sedimentation rate (ESR), a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (GH), Disease Activity Score 28-C-reactive protein (DAS28-CRP), and Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) are reported. Not all of these variables were specified as primary or secondary Outcome Measures in the study protocol and were not individually analyzed.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Correlation coefficient|||Number
1240480|NCT00578305|Secondary|Percentage of Participants Achieving a Major Clinical Response at Week 52|A major clinical response was defined as an improvement of at least 70% in the American College of Rheumatology score from Baseline at Week 52. Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate participant and physician assessments of participant disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”); participant assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein level.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240538|NCT00578175|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4 day follow up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
1240481|NCT00578305|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52|Improvement must be seen in tender and swollen joint counts (28 assessed joints; Joints were evaluated and classified as swollen or not swollen and tender or not tender based on pressure and joint manipulation upon physical examination) and in at least 3|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240482|NCT00578305|Secondary|Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52|The percentage of participants in remission of their rheumatic arthritis at Weeks 24 and 52, as measured by a DAS28 score < 2.6, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240483|NCT00578305|Secondary|Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52|The percentage of participants who had low rheumatic arthritis disease activity at Weeks 24 and 52, as measured by a DAS28 score ≤ 3.2, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240484|NCT00578305|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52|Change of the DAS28 score from Baseline was used to determine the EULAR responses. For a post-Baseline score ≤ 3.2, a change from Baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-Baseline score > 3.2 to ≤ 5.1, a change from Baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-Baseline score > 5.1, a change from Baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-Baseline scores > 3.2. DAS28=(0.56×√(TJC28))+(0.28×√(SJC28))+(0.7×log(CRP))+(0.014×GH), where TJC28=tender joint count (JC) and SJC28=swollen JC (28 joints), GH=a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end=no disease activity, right end=maximum disease activity), and CRP=C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240485|NCT00578305|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, C-reactive protein level (CRP), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
1240486|NCT00578305|Secondary|Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52|There were 2 definitions of improvement in osteitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > than the smallest detectable change. The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240487|NCT00578305|Secondary|Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52|There were 2 definitions of improvement in synovitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > than the smallest detectable change. The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240488|NCT00578305|Secondary|Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52|There were 2 definitions of no progression/no worsening in bone erosion. A participant met the criterion for definition 1 when there was a change in the magnetic resonance imaging erosion score ≤ 0. A participant met the criteria for definition 2 when there was either (1) no change from Baseline in the MRI erosion score, (2) an increase in erosion score and the size of the increase in score was smaller than the smallest detectable change, or (3) a drop in the erosion score. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240489|NCT00578305|Secondary|Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52|No newly eroded joints was defined as no new erosions in joints which were scored 0 at baseline. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
1240490|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52|The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% increase in the volume of the peripheral 1 cm of original (eroded + residual) articular bone using the following scale: 0.0=normal, no osteitis; 0.5=1-17% involvement of original articular bone; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% involvement of original articular bone. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
1240491|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52|The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 3 wrist regions and 5 metacarpophalangeal joints in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% enhancement of the maximum volume of enhancing tissue in the synovial compartment using the following scale: 0.0=normal, no synovitis; 0.5=1-17% estimated volume of enhancement; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% estimated volume of enhancement. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
1240492|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52|The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
1240493|NCT00578305|Primary|Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24|The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
1240876|NCT00576420|Secondary|Laboratory Values Over Time: Hematocrit||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||percentage of red blood cells in blood||Full Range|Median
1240494|NCT00578279|Primary|The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection|Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain.|baseline up to 1 year||||units on a scale||Standard Deviation|Mean
1240495|NCT00578227|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study (up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1240496|NCT00578227|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse events include any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following any vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1240497|NCT00578227|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the safety follow-up (from Month 7 up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1240498|NCT00578227|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the active phase of the study (up to Month 7)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1240499|NCT00578227|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.|During the 7-day period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1240500|NCT00578227|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.|During the 7-day period (Day 0-6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1240501|NCT00578227|Secondary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1240502|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||Participants|||Count of Participants
1240503|NCT00578227|Secondary|Anti-HBs Antibody Titers|Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs before vaccination, i.e. with antibody titers below 3.3 mIU/mL.|||mIU/mL||95% Confidence Interval|Geometric Mean
1240504|NCT00578227|Secondary|Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies|"Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.~A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL."|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs with antibody titers below 3.3 mIU/mL.|||Participants|||Count of Participants
1240505|NCT00578227|Secondary|Anti-HAV Antibody Titers|Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.|||mIU/mL||95% Confidence Interval|Geometric Mean
1240539|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240506|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-HAV Antibodies|Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.|||Participants|||Count of Participants
1240507|NCT00578227|Secondary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7|Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1240508|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||Participants|||Count of Participants
1240509|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-HBs Antibodies|Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.|At month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination.|||Participants|||Count of Participants
1240510|NCT00578227|Secondary|Anti-HBs Antibody Titers|Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titers below 3.3 mIU/mL.|||mIU/mL||95% Confidence Interval|Geometric Mean
1240511|NCT00578227|Primary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1240512|NCT00578227|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||Participants|||Count of Participants
1240513|NCT00578227|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titer greater than or equal to 3.3 mIU/mL.|||Participants|||Count of Participants
1240514|NCT00578227|Primary|Anti-Heptatis A (HAV) Antibody Titers.|Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).|||mIU/mL||95% Confidence Interval|Geometric Mean
1240515|NCT00578227|Primary|Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies|Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.|At Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).|||Participants|||Count of Participants
1240516|NCT00578214|Secondary|Pulse Oximetry at 60 Minutes|Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient’s finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.|60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.|||percentage of oxygenation||Standard Deviation|Mean
1240517|NCT00578214|Secondary|Respiratory Rate at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.|||breaths per minute||Standard Deviation|Mean
1240518|NCT00578214|Secondary|Heart Rate at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.|||heart beats per minute||Standard Deviation|Mean
1240877|NCT00576420|Secondary|Laboratory Values Over Time: Hemoglobin||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||g/dl||Full Range|Median
1240520|NCT00578214|Secondary|Pulse Oximetry at 30 Minutes|Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient’s finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.|30 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.|||percentage of oxygenation||Standard Deviation|Mean
1240521|NCT00578214|Secondary|Respiratory Rate at 30 Minutes||30 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.|||breaths per minute||Standard Deviation|Mean
1240522|NCT00578214|Secondary|Heart Rate at 30 Minutes||30 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the placebo arm did not complete this assessment.|||heart beats per minute||Standard Deviation|Mean
1240523|NCT00578214|Secondary|Blood Pressure at 30 Minutes||30 minutes after drug administration||||mm Hg||Standard Deviation|Mean
1240524|NCT00578214|Secondary|Patient Cognitive Function at 120 Minutes|Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).|120 minutes after drug administration|The analysis was done on the patients who completed the assessment. Two patients in the placebo arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
1240525|NCT00578214|Secondary|Patient Cognitive Function at Baseline and 60 Minutes|Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).|baseline (prior to drug administration) and 60 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the prospective midazolam arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
1240526|NCT00578214|Primary|Patient Anxiety at 60 and 120 Minutes|A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).|60 and 120 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
1240527|NCT00578214|Secondary|Patient Alertness at 60 and 120 Minutes|A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).|60 and 120 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm and 1 patient in the prospective midazolam arm did not complete this assessment.|||units on a scale||Standard Error|Mean
1240528|NCT00578214|Secondary|Patient Alertness at Baseline|A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).|Baseline (prior to drug administration)|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
1240529|NCT00578214|Primary|Patient Anxiety at Baseline|A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).|Baseline (prior to drug administration)|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm, 2 patients in the placebo arm, and 1 patient in the prospective midazolam arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
1240530|NCT00578175|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|For approximately 6 months (Day 0-180)|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1240531|NCT00578175|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits|New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.|For approximately 6 months (Day 0-180)|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1240532|NCT00578175|Secondary|Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)|"Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel."|During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1240533|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
1240534|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Varicella-like Rash||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
1240535|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
1241406|NCT00570765|Secondary|Hepatocellular Injury and Liver Function: ALT|Percent change of alanine transaminase(ALT)from Baseline (Day 0) vs. Day 85/ or early termination.|Baeline and 12 weeks||||Percent change||Standard Error|Mean
1240540|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240541|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240542|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240543|NCT00578175|Secondary|Number of Subjects With Vaccine Response to Havrix|Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240544|NCT00578175|Secondary|Concentration of Antibodies to Rubella Virus|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||International units per milliliter||95% Confidence Interval|Geometric Mean
1240545|NCT00578175|Secondary|Concentration of Antibodies to Measles Virus|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1240546|NCT00578175|Secondary|Antibody Titers to Mumps Virus|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||titer||95% Confidence Interval|Geometric Mean
1240547|NCT00578175|Primary|Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1240548|NCT00578175|Primary|Concentration of Antibodies to Hepatitis A Virus (HAV)|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1240549|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Rubella Virus|Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240550|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Measles Virus|Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240551|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Mumps Virus|Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240552|NCT00578175|Primary|Concentration of Antibodies to Varicella Virus (VZV)|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1240553|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)|Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1240554|NCT00578136|Secondary|The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management.|difference in time to rescue analgesic and the differences in side effects for the two groups.|immediate to 24 hours post-operatively|Time to first rescue dose of opioid medication.|||minutes||Standard Deviation|Mean
1240555|NCT00578136|Primary|The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia.|total postoperative opioid and any additional analgesic medications.|immediate to 24 hour post-operatively||||mg kg-1||95% Confidence Interval|Mean
1240556|NCT00578071|Secondary|Pathological Complete Response Rates Associated With This Regimen.|Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy.|90 days|Surgery was determined according to risk factors, patient consent and resectability.|||percentage of participants|||Number
1240557|NCT00578071|Secondary|Overall Survival Rates for the Patients Studied on This Protocol.|Number of patients alive one year after completing study protocol treatment.|One year||||participants|||Number
1240558|NCT00578071|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)||Within 30 days of the last day of radiation|All patients who received chemoradiation.|||participants|||Number
1240559|NCT00578071|Primary|Panitumumab Maximum Tolerated Dose in Milligrams (mg)||60 days|Per protocol and intention to treat (ITT).|||mg|||Number
1240560|NCT00577889|Secondary|Confirmed Response Rate|"A confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).~Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.Evaluated using RECIST criteria."|2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment||||participants|||Number
1240561|NCT00577889|Secondary|Time to Disease Progression|"The time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).~Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD."|Time from registration to documentation of disease progression, assessed up to 2 years||||months||95% Confidence Interval|Median
1240562|NCT00577889|Secondary|Overall Survival Time|Overall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|Assessed up to 2 years from registration||||months||95% Confidence Interval|Median
1240563|NCT00577889|Primary|Six Month Survival Rate|"A patient that is alive at 6 months is considered a treatment success. Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|6 months||||percentage of patients||95% Confidence Interval|Number
1240564|NCT00577863|Primary|Number of Subjects With Forteo B Pen Complaints at 46 Weeks|Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|46 weeks|All participants who received at least one injection of study drug.|||number of participants with complaints|||Number
1240565|NCT00577863|Primary|Summary of Forteo B Pen Complaints at 46 Weeks|Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|46 weeks|All participants who received at least one injection of study drug.|||number of complaints|||Number
1240566|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of what could be done to improve the Forteo B Pen Instructions for Use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240567|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they remove the needle from their Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240568|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they attach a needle to their Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240569|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Reusing Needles|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on whether or not they sometimes reuse needles.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240570|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are away from home.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240571|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are at home.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240572|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen reduces their reluctance to take injections.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240573|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how convenient Forteo B Pen was to use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240574|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how confident they were that they received the medication with the Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240575|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how satisfied they were with the Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240576|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of the overall ease of use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240577|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to use the Forteo B Pen Instructions for Use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240578|NCT00577863|Secondary|Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to hold the pen while injecting.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240579|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to push the black injections button to administer the dose.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240580|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to set the dose.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240581|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove a used needle.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240582|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to attach a new needle.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240583|NCT00577863|Secondary|Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to replace the pen cap.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240584|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen cap.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240585|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to learn to use the pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240586|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Read Label|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to read the label.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240587|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen from the package.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
1240604|NCT00577824|Secondary|Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)|Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||ratio||Standard Error|Mean
1240588|NCT00577863|Secondary|Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen|To assess subject preferences for use of the User Manual/Instructions for Use that came with the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240589|NCT00577863|Secondary|Summary of Subject Preference Assessments - Overall Ease of Use|To assess subject preferences for overall ease of use for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240590|NCT00577863|Secondary|Summary of Subject Preference Assessments - Removing a Used Needle|To assess subject preferences for removing a used needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240591|NCT00577863|Secondary|Summary of Subject Preference Assessments - Assurance That Drug is Delivered|To assess subject preferences for assurance that drug is delivered for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240592|NCT00577863|Secondary|Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose|To assess subject preferences for force on the plunger needed to inject a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240593|NCT00577863|Secondary|Summary of Subject Preference Assessments - Injecting a Dose|To assess subject preferences for injecting a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240594|NCT00577863|Secondary|Summary of Subject Preference Assessments - Setting the Dose|To assess subject preferences for setting the dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240595|NCT00577863|Secondary|Summary of Subject Preference Assessments - Attaching a New Needle|To assess subject preferences for attaching a new needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240596|NCT00577863|Primary|Number of Subjects With Forteo B Pen Complaints at 8 Weeks|Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|8 weeks|All participants who received at least one injection of study drug.|||number of participants with complaints|||Number
1240597|NCT00577863|Secondary|Summary of Subject Preference Assessments - Learning to Use the Pen|To assess subject preferences for learning to use the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240598|NCT00577863|Secondary|Summary of Subject Preference Assessments - Overall Preference|To assess overall subject preferences for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
1240599|NCT00577863|Primary|Summary of Forteo B Pen Complaints at 8 Weeks|Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|8 weeks|All participants who received at least one injection of study drug.|||number of complaints|||Number
1240600|NCT00577824|Secondary|Change in 1,5-anhydroglucitol|Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||mcg/mL||Standard Error|Mean
1240601|NCT00577824|Secondary|Change in C-peptide|Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||ng/mL||Standard Error|Mean
1240602|NCT00577824|Secondary|Change in Serum Insulin|Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||mcU/mL||Standard Deviation|Mean
1240603|NCT00577824|Secondary|Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)|Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||ratio||Standard Error|Mean
1240605|NCT00577824|Secondary|7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24|Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||mg/dL||Standard Deviation|Mean
1240606|NCT00577824|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||ratio (cm/cm)||Standard Error|Mean
1240607|NCT00577824|Secondary|Change in Waist Size|Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||cm||Standard Error|Mean
1240608|NCT00577824|Secondary|Change in Triglycerides|Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)|baseline, week 24|Full analysis set; Last observation carried forward|||mg/dL||Standard Error|Mean
1240609|NCT00577824|Secondary|Change in High Density Lipoprotein Cholesterol (HDL-C)|Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)|baseline, week 24|Full analysis set; Last observation carried forward.|||mg/dL||Standard Error|Mean
1240610|NCT00577824|Secondary|Change in Low Density Lipoprotein Cholesterol (LDL-C)|Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)|baseline, week 24|Full analysis set; Last observation carried forward.|||mg/dL||Standard Error|Mean
1240611|NCT00577824|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)|baseline, week 24|Full analysis set; Last observation carried forward|||mg/dL||Standard Error|Mean
1240612|NCT00577824|Secondary|Change in Body Weight|Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)|baseline, week 24|Full analysis set; Last observation carried forward|||kg||Standard Error|Least Squares Mean
1240613|NCT00577824|Secondary|Change in Fasting Blood Glucose|Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)|baseline, week 24|Full analysis set; Last observation carried forward|||mg/dL||Standard Error|Least Squares Mean
1240614|NCT00577824|Secondary|Percentage of Patients Achieving HbA1c < 6.5%|Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)|24 weeks|Full analysis set; Last observation carried forward. Only subjects whose HbA1c was >=6.5% at baseline were included.|||percentage of participants|||Number
1240615|NCT00577824|Secondary|Percentage of Patients Achieving HbA1c < 7.0%|Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)|24 weeks|Full analysis set; Last observation carried forward. Only those patients with HbA1c >=7% at baseline included.|||percentage of participants|||Number
1240616|NCT00577824|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24|Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)|baseline, 24 weeks|Full analysis set; Last observation carried forward.|||Percentage of hemoglobin||Standard Error|Least Squares Mean
1240617|NCT00577772|Primary|Oro-cecal Transit Time as Measured by SmartPill|Oro-cecal transit time is the period of time needed by the head of the meal to reach the cecum, which is frequently used as an indicator of small intestinal transit time. Oro-cecal transit was to be determined simultaneously in the study subjects by both the SmartPill technique and the lactulose H_2BT technique.|baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline|Data were not analyzed as study was terminated early due to low enrollment.||||||
1240618|NCT00577720|Secondary|Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population||Baseline and Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1240619|NCT00577720|Secondary|Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population||Baseline and Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1240620|NCT00577720|Primary|Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population||Baseline and Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1240621|NCT00577707|Secondary|Number of Patients With a Response Rate, 3-year Overall Survival and Median Survival of Patients With a Known EGFR Mutation Receiving Neoadjuvant Chemotherapy and Erlotinib (and Adjuvant Erlotinib).||3 years|Data was not collected because of lack of accrual.||||||
1240622|NCT00577707|Secondary|Number of Participants With Response After 21 Days of Single Agent Erlotinib for Stage IB-IIIA NSCLC With a Known EGFR Mutation||calculate the response rate after 21 days of single agent erlotinib|Data was not collected because of lack of accrual.||||||
1240623|NCT00577707|Primary|Number of Patients With Pathologic Complete Response Rate|Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the measured lesions, and any increase of less than 25% in the sum of the products of the measured lesions. There may be no appearance of new disease sites for this category. Progressive Disease (PD): A ≥25% increase in one or more lesions, or appearance of new lesions.|Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.||||participants|||Number
1240679|NCT00577460|Secondary|UPDRS I Total Score and Change From OL Baseline at Week 80|UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood|OL baseline and week 80|Patients from FAS with values of UPDRS I at week 80|||units on a scale||Standard Error|Least Squares Mean
1240624|NCT00577655|Secondary|Weekly Average Number of Puffs of Rescue Medication Taken Each Day for Study Weeks 1, 2 and 3|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night and the number of puffs of rescue albuterol used during the night after going to bed. At the end of each day, the number of puffs of albuterol rescue medication used during the day were recorded.|Weeks 1, 2, 3|ITT population|||Number of puffs per day||95% Confidence Interval|Mean
1240625|NCT00577655|Secondary|Weekly Average Peak Expiratory Flow (PEF) Obtained Pre-Dose Each Morning|Participants measured their PEF as trained by taking as deep a breath as possible, placing their mouth firmly around the mouthpiece of the flow meter to form a tight seal, and exhaling as hard and as fast as possible. Subjects repeated the process twice at intervals of approximately 30 seconds, and then recorded the highest of the three PEF values on the diary card.|Weeks 1, 2, 3|ITT population|||Liters/minute||Standard Error|Mean
1240626|NCT00577655|Secondary|The Number of Asthma-Related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.|Run-in (Days -21 to -1), Weeks 1, 2, 3|ITT population|||awakenings/week||Standard Deviation|Mean
1240627|NCT00577655|Secondary|Weekly Average Highest (Worst) Daily Asthma Symptom Scores for Weeks 1, 2 and 3|"Highest daily asthma symptom scores by study week. For this assessment, patients self-evaluate and record on the diary card the following asthma symptoms experienced during the day (i.e. last 12-14 hours): wheeze, shortness of breath, cough, tightness of chest. The worst of these symptoms were scored daily on a four-point scale:~0 = No symptoms occurred~1 = Symptom occurred but did not interfere with daily activity~2 = Symptom occurred but was sometimes annoying or interfered with daily activity~3 = Symptom present even at rest and was annoying or interfered with daily activity"|Weeks 1, 2, 3|ITT population.|||units on a scale||Standard Error|Mean
1240628|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=12% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+12% increase in PEF within 30 minutes of dose.~The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT|||percentage of participants|||Number
1240629|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=15% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+15% increase in PEF within 30 minutes of dose.~The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT|||percentage of participants|||Number
1240630|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=12% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+12% increase in FEV1 within 30 minutes of dose.~The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT|||percentage of participants|||Number
1240631|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=15% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+15% increase in FEV1 within 30 minutes of dose.~The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT|||percentage of participants|||Number
1240632|NCT00577655|Secondary|Time To Maximum Peak Expiratory Flow (PEF) Over Six Hours Post-Dose On Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown.~Time to maximum PEF is defined as the number of minutes required for the baseline PEF to increase to the highest PEF post-dose for the 6 hour observation period. Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day."|Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing|ITT population; Last Observation Carried Forward (LOCF) used for Day 22|||minutes||95% Confidence Interval|Median
1240633|NCT00577655|Secondary|Time To Maximum Forced Expiratory Volume in One Second (FEV1) Over Six Hours Post-Dose On Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters.~Time to maximum FEV1 is defined as the number of minutes required for the baseline FEV1 to increase to the highest FEV1 post dose during the 6 hour observation period.~Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Intent-To-Treat (ITT) population; Last Observation Carried Forward (LOCF) used for Day 22|||minutes||95% Confidence Interval|Median
1240634|NCT00577655|Secondary|Maximum Percent-Predicted FEV1 (Max PPFEV1, %) Observed up to Two Hours Following Completion of Dosing on Study Days 1 and 22 (Observed Case)|The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria.|Days 1 and 22: 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Observed cases (i.e. available data only)|||percentage of predicted FEV1||Standard Error|Mean
1241407|NCT00570765|Secondary|Hepatocellular Injury and Liver Function: GGT|Percent change of gamma-glutamyl transferase (GGT)from Baseline (Day 0) vs. Day 85/ or early termination (ET) visit.|Baeline and 12 weeks||||Percent change||Standard Error|Mean
1240635|NCT00577655|Secondary|Baseline-Adjusted Area-under-the Effect Curve for Peak Expiratory Flow (PEF) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown.~The area under-the-effect curves for PEF were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times."|Baseline (Day 1 or Day 22: 30±5 and 5±2 minutes prior to dosing Day 22: 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)|||Liters/Minute*Hours||Standard Error|Mean
1240636|NCT00577655|Secondary|Baseline Adjusted Area-under-the-Effect Curve for Percent of Predicted Forced Expiratory Volume in One Second (FEV1) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria.~The area under-the-effect curves for percent-predicted FEV1 were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times."|Baseline (Day 1 or Day 22: 35±5 and 10±2 minutes prior to dosing), Day 22 (5±2, 15±5, 30±5, 45±5, 60±10, 120±10, 240±10, and 360±10 minutes post-dosing or last observation)|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)|||Percent of Predicted FEV1 * Hours||Standard Error|Mean
1240637|NCT00577655|Secondary|Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) up to Two Hours Post-Dose (PEFmax%0-2) on Study Days 1 and 22 Using Observed Cases|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing on study days 1 and 22. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing|Observed cases|||percentage change from baseline||Standard Error|Mean
1240638|NCT00577655|Secondary|Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) up to Two Hours Post-Dose (FEV1max%0-2, %) on Study Days 1 and 22 Using Observed Cases|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using test day baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Observed cases (i.e. available data only)|||percentage change from baseline||Standard Error|Mean
1240639|NCT00577655|Primary|Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) Observed up to Two Hours Post Dose (PEFmax%0-2) on Day 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|30±5 and 5±2 minutes prior to dosing, and at 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing on Day 22 or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)|||percentage change from baseline||Standard Error|Mean
1240640|NCT00577655|Primary|Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing on Day 22 or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)|||percentage change from baseline||Standard Error|Mean
1240641|NCT00577642|Primary|Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr|Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.|6 months||||Participants|||Count of Participants
1240642|NCT00577629|Secondary|Secondary Malignancies|The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.|10 years|All patients who received chemotherapy|||Participants|||Count of Participants
1240643|NCT00577629|Secondary|Overall Response|"Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.~CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PR =~>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.~No increase should be observed in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.~Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.~No new sites of disease should be observed."|up to 1 year||||percentage of participants|||Number
1240644|NCT00577629|Secondary|Overall Survival|Overall Survival is measured from the first day of chemotherapy until death from any cause.|10 years|All subjects who received chemotherapy|||percentage of participants|||Number
1240645|NCT00577629|Secondary|Disease-free Survival|Disease-free survival is measured from the date of CR or CRu to date of relapse or death|10 years|"Subjects who achieved a complete response. 9 patients experienced disease progression; 4 patients died.~4 patients were lost-to-follow-up and 11 patients are still living, so DFS was calculated using the last date of follow-up."|||months||Full Range|Mean
1240646|NCT00577629|Primary|1 Year Progression-free Survival Rate|Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: >50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.|1 year||||percentage of participants||95% Confidence Interval|Number
1240647|NCT00577590|Primary|Percent Change in Plasma Triglycerides||Baseline and 3 months|Data presented are stratified by sex|||percent change||Standard Deviation|Mean
1240648|NCT00577512|Primary|Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer.|"Complete Response (CR) defined as all of the following for a minimum of 2 months: a) absence of urine and serum M-components by immunofixation; b) bone marrow should be adequately cellular (>20%); c) normal serum calcium; d) no new bone lesions or enlargement of existing lesions.~Near Complete Response included all elements of CR except immunofixation studies remained positive."|12 months||||participant response|||Number
1240649|NCT00577473|Secondary|Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)|0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients|||Percentage of Participants|||Number
1240650|NCT00577473|Secondary|Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)|0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients|||Percentage of Participants|||Number
1240651|NCT00577473|Secondary|Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)|0-generally well, 1-fair, 2-poor, 3-terrible|Week 6|All Randomized Patients|||Percentage of Participants|||Number
1240652|NCT00577473|Secondary|Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)|0-generally well, 1-fair, 2-poor, 3-terrible|Week 3|All Randomized Patients|||Percentage of Participants|||Number
1240653|NCT00577473|Secondary|Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)|0-no blood seen, 1- streaks of blood with stool less than half of the time, 2- obvious blood with stool most of the time, 3- blood alone passed. Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients|||Percentage of Participants|||Number
1240654|NCT00577473|Secondary|Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)|0: no blood seen, 1: streaks of blood with stool less than half of the time, 2: obvious blood with stool most of the time, 3: blood alone passed, Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients|||Percentage of Participants|||Number
1240655|NCT00577473|Secondary|Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)|0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients|||Percentage of Participants|||Number
1240656|NCT00577473|Secondary|Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)|0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients|||Percentage of Participants|||Number
1240657|NCT00577473|Secondary|Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients|PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients|||Percentage of Participants|||Number
1240658|NCT00577473|Secondary|Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients|PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients|||Percentage of Participants|||Number
1240659|NCT00577473|Secondary|Percentage of Patients Classified as Treatment Success at Week 3, ITT Population|Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.|3 weeks|ITT Population|||Percentage of Participants|||Number
1240660|NCT00577473|Primary|Percentage of Patients Classified as Treatment Success at Week 6, ITT Population|Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.|6 weeks|ITT Population|||Percentage of Participants|||Number
1240661|NCT00577460|Secondary|Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set|The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.|Baseline, 80 weeks|Treated Set - all patients dispensed drug and documented to have taken at least one dose|||participants|||Number
1240662|NCT00577460|Secondary|Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set|ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)|OL Baseline and Week 80||||units on a scale||Standard Deviation|Mean
1240663|NCT00577460|Secondary|Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||kg||Standard Deviation|Mean
1240664|NCT00577460|Secondary|Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||kg||Standard Deviation|Mean
1240665|NCT00577460|Secondary|Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||beats per minute||Standard Deviation|Mean
1240666|NCT00577460|Secondary|Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||beats per minute||Standard Deviation|Mean
1240667|NCT00577460|Secondary|Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||mm Hg||Standard Deviation|Mean
1240668|NCT00577460|Secondary|Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||mm Hg||Standard Deviation|Mean
1240669|NCT00577460|Secondary|Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||mm Hg||Standard Deviation|Mean
1240670|NCT00577460|Secondary|Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||mm Hg||Standard Deviation|Mean
1240671|NCT00577460|Primary|Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.|80 weeks|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)|||Percentage of participants|||Number
1240672|NCT00577460|Secondary|Number of Participants With Serious Adverse Events||80 weeks|The Treated Set (TS) included all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment|||Patients|||Number
1240673|NCT00577460|Secondary|Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline||OL baseline and week 80|Patients from Treated Set (all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80|||Patients|||Number
1240674|NCT00577460|Secondary|Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80||OL baseline and week 80|Patients from FAS with documentation of levodopa (L-DOPA) daily dose at week 80|||Patients|||Number
1240675|NCT00577460|Secondary|Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80|PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD|OL baseline and week 80|Patients from FAS with values of PFS-16 score at week 80|||Unit on a scale||Standard Error|Least Squares Mean
1240676|NCT00577460|Secondary|UPDRS IV Total Score and Change From OL Baseline at Week 80|UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy|OL baseline and week 80|Patients from FAS with values of UPDRS IV at week 80|||Unit on a scale||Standard Error|Least Squares Mean
1240677|NCT00577460|Secondary|UPDRS III Total Score and Change From OL Baseline at Week 80|UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms|OL baseline and week 80|Patients from FAS with values of UPDRS III at week 80|||units on a scale||Standard Error|Least Squares Mean
1240678|NCT00577460|Secondary|UPDRS II Total Score and Change From OL Baseline at Week 80|UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities|OL baseline and week 80|Patients from FAS with values of UPDRS II at week 80|||units on a scale||Standard Error|Least Squares Mean
1240680|NCT00577460|Secondary|Number of Participants With Response in PGI-I for Early Morning Off Symptoms|"Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders"|32 weeks|Patients from FAS with values of PGI-I for early morning off symptoms at week 32|||Patients|||Number
1240681|NCT00577460|Secondary|Number of Participants With Response in PGI-I|"Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders"|32 weeks|Patients from FAS with values of PGI-I at week 32|||Patients|||Number
1240682|NCT00577460|Secondary|Number of Participants With Response in CGI-I|"Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders"|32 weeks|Patients from FAS with values of CGI-I at week 32|||Patients|||Number
1240683|NCT00577460|Secondary|Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
1240684|NCT00577460|Secondary|Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
1240685|NCT00577460|Secondary|Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
1240686|NCT00577460|Secondary|Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
1240687|NCT00577460|Secondary|Number of Participants With Response in Percentage Off Time During Waking Hours|Response means >=20% improvement relative to OL baseline in the % off-time during waking hours|80 weeks|Patients from FAS with values of off time during waking hours at 80 weeks|||Patients|||Number
1240688|NCT00577460|Secondary|Percentage Off Time During Waking Hours Total Score: Change From Baseline|"Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).~A negative change implies improvement"|Baseline and week 80|Patients from FAS with values of UPDRS II+III at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
1240689|NCT00577460|Secondary|Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time|A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|One week|Patients from FAS and who maintain the final dose of the previous study|||Patients|||Number
1240690|NCT00577460|Secondary|Number of Participants With UPDRS II+III Response|A response means an improvement of >=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Week 80|Patients from FAS with values of UPDRS II+III at week 80|||Patients|||Number
1240691|NCT00577460|Secondary|UPDRS II+III Change From Open Label (OL) Baseline|UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|OL Baseline and week 80|Patients from FAS with values of UPDRS II+III at week 80|||Scores on a scale||Standard Error|Least Squares Mean
1240692|NCT00577460|Secondary|Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III|Unified Parkinson’s Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|One week|Patients from Full Analysis Set (FAS included all patients who were dispensed study medication, had received at least one dose of study drug and had provided any post-baseline efficacy assessment) and who maintain the final dose of the previous study|||Patients|||Number
1240693|NCT00577408|Primary|Treatment Retention|compliance with being retained in treatment protocol|over the course of 24 weeks or length of study participation||||Participants|||Count of Participants
1240694|NCT00577395|Secondary|Erosion Index of the Distal Radius|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.|6 months|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.||||||
1240695|NCT00577395|Primary|Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius|"The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).~NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed."|12 months|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.||||||
1240696|NCT00577382|Secondary|Time to Progression|Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles).|The analysis dataset is comprised of treated patients. The majority of patients were off-treatment due to disease progression and thus the relevant observation time frame for this outcome is time on treatment.|||months||95% Confidence Interval|Median
1240697|NCT00577382|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m).|The analysis dataset is comprised of treated patients.|||months||95% Confidence Interval|Median
1240698|NCT00577382|Secondary|Best Overall Response Rate|The best overall response rate was defined as achieving partial response (PR) or complete response (CR) on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles.|The analysis dataset is comprised of treated patients.|||proportion of participants||95% Confidence Interval|Number
1240699|NCT00577382|Primary|2-month Progression-free Survival Rate|2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.|The analysis dataset is comprised of treated patients.|||proportion of patients||95% Confidence Interval|Number
1240700|NCT00577356|Primary|Number of Participants With Pathological Complete Response.|CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen|The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.|Study was stopped before analysis occured.|||participants|||Number
1240701|NCT00577135|Secondary|Net Fluid Loss||Through 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mL||Standard Deviation|Mean
1240702|NCT00577135|Secondary|Net Fluid Loss||Through 48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mL||Standard Deviation|Mean
1240703|NCT00577135|Secondary|Net Fluid Loss||Through 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mL||Standard Deviation|Mean
1240704|NCT00577135|Secondary|Treatment Failure|Treatment failure is defined as the patient met cardiorenal syndrome endpoint, worsening or persistent heart failure endpoint, patient died, or there was clinical evidence of overdiuresis requiring intervention within first 72 hours after randomization|Within 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||percentage of participants|||Number
1240705|NCT00577135|Secondary|Presence of Cardiorenal Syndrome||Within 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||percentage of participants|||Number
1240706|NCT00577135|Secondary|Change in NTproBNP||baseline and Day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||pg/mL||Standard Deviation|Mean
1240707|NCT00577135|Secondary|Change in NTproBNP||baseline and Day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||pg/mL||Standard Deviation|Mean
1240708|NCT00577135|Secondary|Change in B-type Natriuretic Peptide|Change in NTproBNP|baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||pg/mL||Standard Deviation|Mean
1240709|NCT00577135|Secondary|Change in Uric Acid||baseline and Day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240710|NCT00577135|Secondary|Change in Uric Acid||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240711|NCT00577135|Secondary|Change in Uric Acid||baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240712|NCT00577135|Secondary|Change in Cystatin C||baseline and day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/L||Standard Deviation|Mean
1240713|NCT00577135|Secondary|Change in Cystatin C||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/L||Standard Deviation|Mean
1240714|NCT00577135|Secondary|Dyspnea VAS|Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better|72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
1240715|NCT00577135|Secondary|Dyspnea VAS|Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better|48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
1240716|NCT00577135|Secondary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-4800; higher score is better|48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
1240717|NCT00577135|Secondary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-2400; higher score is better|Measured at 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
1240718|NCT00577135|Secondary|Change in Serum Creatinine||baseline and day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240719|NCT00577135|Secondary|Change in Serum Creatinine||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240720|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 96 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240721|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240722|NCT00577135|Secondary|Change in Cystatin C||baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/L||Standard Deviation|Mean
1240723|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240724|NCT00577135|Secondary|Dyspnea, as Determined by Visual Analog Scales|Global Visual Analog Scale Scale Range 0-2400; higher score is better|Measured at 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
1243479|NCT00555997|Secondary|Responder/Non-responder|A responder during phase 1 or phase 2 is someone who demonstrated a 50% or greater decrease in HAMD-17 scores during phase 1 or phase 2 (corresponding).|6 weeks||||percentage of patients|||Number
1240725|NCT00577135|Secondary|Proportion of Patients Free of Congestion||Measured at 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||percentage of participants|||Number
1240726|NCT00577135|Secondary|Change in Weight||baseline and 96 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||lbs||Standard Deviation|Mean
1240727|NCT00577135|Primary|Change in Serum Creatinine||Measured at baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
1240728|NCT00577135|Primary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-7200; higher score is better|Measured at 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
1240729|NCT00577122|Secondary|MPA Trough Concentration|To explore genetic determinants of MPA bioavailability and trough concentration by showing average MPA levels at cycle 1 (Day 10-14) and cycle 2 (Day 1).|Cycle 1 (Day 10-14) and Cycle 2 (Day 1)|All patients with available data|||ng/mL||Standard Deviation|Mean
1240730|NCT00577122|Secondary|MPA Trough Level > 50 ng/mL When Have Clinical Benefit|To explore the relationship between MPA trough level and clinical benefit. This is done by seeing if the MPA concentrations remained > 50 ng/mL after initial dose escalation for those patients who showed clinical benefit. The number shows how many of the patients who showed clinical benefit had MPA concentrations > 50 ng/mL.|baseline through end of treatment|Patients who showed clinical benefit (CR, PR, or SD > 6 months)|||participants|||Number
1240731|NCT00577122|Secondary|Grade 3 or 4 Adverse Events Related to Treatment|To evaluate the toxicity of MPA and MPA + ldoCM in this patient population by the number of patients who have grade 3 or 4 adverse events that are related to treatment.|baseline through end of treatment|All patients in the study|||participants|||Number
1240732|NCT00577122|Primary|Clinical Benefit Rate (CR + PR + SD > 6 Months).|To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.|baseline through end of study, up to 3 years|All Patients on study.|||Percent of Participants||95% Confidence Interval|Number
1240733|NCT00577096|Secondary|Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)|Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.|up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||g/dl||Standard Deviation|Mean
1240734|NCT00577096|Secondary|Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)|Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.|up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||g/dl||Standard Deviation|Mean
1240735|NCT00577096|Primary|Total Number of Days of Stem Cell Collection (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Days||Standard Deviation|Mean
1240736|NCT00577096|Primary|Total Number of Days of Stem Cell Collection (Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Days||Standard Deviation|Mean
1240737|NCT00577096|Primary|Number of Stem Cell Collection Attempts (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Stem Cell Collection Attempts||Standard Deviation|Mean
1240738|NCT00577096|Primary|Number of Stem Cell Collection Attempts (Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Stem Cell Collection Attempts||Standard Deviation|Mean
1240739|NCT00577096|Primary|Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Platelet Transfusions||Standard Deviation|Mean
1240740|NCT00577096|Primary|Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Platelet transfusions||Standard Deviation|Mean
1240741|NCT00577096|Primary|Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)|The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.|up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||RBC Transfusions||Standard Deviation|Mean
1240742|NCT00577096|Primary|Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)|The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.|up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||RBC Transfusions||Standard Deviation|Mean
1240743|NCT00577083|Secondary|Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved.|During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap.|after 2nd colonoscopy was completed in 24hrs|Patients aged 50 years or older who were able to give informed consent and were scheduled for elective colonoscopy at IUH were eligible for enrollment. Exclusion criteria were American Society of Anesthesiologists class III or higher, previous surgical resection of the colon or rectum, inflammatory bowel disease, and current use of anticoagulants.|||Minutes||Standard Error|Mean
1240744|NCT00577083|Primary|Number of Adenomas|Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted.|after the second colonoscopy is completed||||First Colonoscopy number of adenomas|||Number
1240745|NCT00577031|Secondary|European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score|"Quality of life (QoL) assessments were used to derive pre-specified QoL scores according to the QoL manual “EQ-5D-3 Level (3L) user guide for instrument version 4.0. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The visual analog scale (VAS) component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The overall health score absolute changes were calculated for each participant as follows: (score at the end of treatment minus score at baseline). EQ-5D health states were converted into EQ-5D-3L raw index value by applying the scoring algorithm based on the European EQ-net VAS set. The raw index was chosen instead of rescaled index, since the questionnaire was used in order to obtain a quality of life assessment. The raw index scores ranged from 0 (worst health state) to 100 (best health state)."|Baseline, every 9 weeks (every 3 cycles), at end-of-treatment up to 5 years|ITT population, only participants who had EQ-5D-3L scores for both baseline and last visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
1240746|NCT00577031|Secondary|Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status|"The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.~The K-Ras and/or the B-Raf gene mutation status of participants was evaluated by the central laboratory using tumor samples. Wild-type participants did not have a mutation in either gene."|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population; only participants with a known K-Ras and/or B-Raf gene mutation status and at least 1 post-baseline tumor assessment. Number (n) equals (=) number of participants with either wild-type or K-Ras/B-Raf gene mutation.|||percentage of participants|||Number
1240747|NCT00577031|Secondary|Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery|The percentage of participants who underwent surgery during the study period with an evaluation of their disease status after surgery. The surgery during the study period was described by reason: curative, palliative, biopsy, other, or unknown. Residual disease status after surgery was described as: no residual disease due to radical surgery, presence of residual disease, unknown or not applicable.|At surgery, at least 6 to 8 weeks after last dose of bevacizumab up to 5 years|The 52 participant subpopulation of the ITT population who underwent surgery during the time period of the study.|||percentage of participants|||Number
1240748|NCT00577031|Secondary|Overall Survival: Time to Event|Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive. Median overall survival was estimated using the Kaplan-Meier method.|Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years|ITT population.|||months||95% Confidence Interval|Median
1243480|NCT00555997|Primary|Hamilton Depression Rating Scale (HAM-D-17) Scores|Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.|6 weeks||||points||Standard Deviation|Mean
1240749|NCT00577031|Secondary|Overall Survival: Percentage of Participants That Died Due to Any Cause|Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive.|Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years|ITT population.|||percentage of participants|||Number
1240750|NCT00577031|Secondary|Time to Treatment Failure|Time to treatment-failure was defined as the time from the first day of treatment to discontinuation of treatment for any reason, including: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). For participants who did not experience a qualifying event, their data were censored at the earlier of either the date of last tumour assessment or the date of the last intake of study medication. Median time to treatment-failure was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population.|||months||95% Confidence Interval|Median
1240751|NCT00577031|Secondary|Percentage of Participants With Treatment Failure|Treatment-failure was defined as discontinuation of treatment for any reason, including the following qualifying events: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population.|||percentage of participants|||Number
1240752|NCT00577031|Secondary|Duration of Stable Response|For participants with a best overall response of CR, PR, or SD during first line treatment, the duration of stable response was measured from the time that the criteria for CR, PR, or SD (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of stable response was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.|||months||95% Confidence Interval|Median
1240753|NCT00577031|Secondary|Percentage of Participants With a Stable Response During First Line Treatment|Stable response defined as participants with a best overall response of CR, PR, or stable disease (SD), defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.|||percentage of participants|||Number
1240754|NCT00577031|Secondary|Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event|For participants with a best overall response of CR or PR, the duration of overall response was measured from the time that the criteria for CR or PR (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of overall response was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.|||months||95% Confidence Interval|Median
1240755|NCT00577031|Secondary|Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment|CR and PR were defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.|||percentage of participants|||Number
1240756|NCT00577031|Secondary|Time to CR or PR Overall Response - Time to Event|Time to overall response (CR or PR) was calculated as the time between the date of start of treatment until first documented response (CR or PR defined per RECIST v1.0). Participants who did not achieve CR or PR were censored at the date of progression, death, or at last adequate tumor assessment date. Median time to CR or PR overall response was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population.|||months||95% Confidence Interval|Median
1240766|NCT00576927|Secondary|Daytime Engagement Status|Trained research technicians observed the subjects behavior during assessment phases every 15 minutes for one full minute. Specific behavioral definitions were employed to record whether the subject was in or out of bed, awake or asleep (eyes closed with no purposeful movement for at least 60 consecutive seconds), actively engaged in an activity (reading, watching television, conversation, a specific group activity, etc), and whether any physical or verbal agitation was noted.|All Assessment Phases, up to one week||||percentage of engaged observations||Standard Deviation|Mean
1240757|NCT00577031|Primary|PFS: Time to Event|PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented that neither a relapse nor a new colorectal cancer had occurred. Median PFS was estimated using the Kaplan-Meier method.|Baseline and Day 1 of every cycle until disease progression or death up to 5 years|ITT population.|||months||95% Confidence Interval|Median
1240758|NCT00577031|Secondary|Percentage of Participants With a CR or PR Among Participants in the ITT Population|CR and PR were defined using RECIST v1.0. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population.|||percentage of participants|||Number
1240759|NCT00577031|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment|The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|Subset of participants in the ITT population who had at least 1 post-baseline tumor assessment.|||percentage of participants|||Number
1240760|NCT00577031|Primary|Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death|PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Baseline and Day 1 of every cycle until disease progression or death up to 5 years|Intent-to-treat (ITT) population: all enrolled participants who received at least 1 dose of all study medications and had at least 1 measurable lesion according to the Response Evaluation Criteria In Solid Tumours (RECIST) criteria.|||percentage of participants|||Number
1240761|NCT00577005|Secondary|Cocaine Craving|Weekly cocaine craving was measure at intake and weekly after with the Visual Analog Scale (VAS) of the Cocaine Selective Severity Assessment. The VAS measures the intensity of cocaine craving with a scale from 0 (No desire at all) to 7 (Unable to resist), and frequency of cocaine craving in the previous 24 hours with a scale from 0 ( never) to 7 ( all the time). The scale is totaled for a maximum number of 14, the minimum is 0. (Kampman et al., 1998; Mulvaney et al., 1999).|Weekly from baseline to week 12|Intent to treat sample|||units on a scale||Standard Error|Mean
1240762|NCT00577005|Secondary|Treatment Retention|Weekly from week 1 to 13|Week 13|Intent-treat-sample (ITT) that was inducted onto methadone and received one dose of study medication on week 2.|||participants|||Number
1240763|NCT00577005|Secondary|Change of Thrice Weekly Opioid Free Urine Toxicology From Week 1 to 13|The secondary outcome variable was the change from baseline to week 13 of the thrice weekly opioid-free urine scores. In this repeated ordinal variable, 0 represented all 3 urines samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urines samples submitted by the subjects were negative for opioids excluding methadone. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data summarized by number of participants who were had opioid free urine samples (score 2) per week by group.|Weekly from baseline to week 12|The intent-to-treat (ITT) sample were the 28 subjects were randomized and received one dose of study medication.|||participants with opioid free urine|||Number
1240764|NCT00577005|Primary|Change of Thrice Weekly Cocaine Free Urine Toxicology From Week 1 to 13|The primary outcome variable was the change from baseline to week 13 of the thrice weekly cocaine-free urine scores. In this repeated ordinal variable, 0 represented all 3 urine samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urine samples submitted by the subjects were negative for cocaine. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data is summarized as number of participant that were cocaine free urine (score 2) per week by group.|Weekly from baseline to week 12|The intent-to-treat (ITT) sample were the 28 subjects were randomized and received one dose of study medication.|||participants that were cocaine free|||Number
1240765|NCT00576927|Other Pre-specified|Daytime Sleep|As measured by percent of daytime behavioral observations observed asleep|All Assessment Phases, up to one week||||percentage of daytime sleep observations||Standard Deviation|Mean
1240878|NCT00576420|Secondary|Percent Change in Vital Signs: Respiratory Rate|Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set|||percent change||Full Range|Median
1240767|NCT00576927|Primary|Number of Participants Meeting Good Sleep Latency Criteria|"Sleep Latency Criteria for Good Latency measured by behavioral observations conducted every 10-15 minutes after 4pm until 11pm.~Good latency is described as subject asleep in under 20 minutes on 51% of the nights observed in a week."|All assessment periods, up to one week|30 subjects enrolled into the behavioral intervention. 4 subjects responded to the sleep hygiene intervention (SHI) arm and completed the study. 3 subjects were excluded for various reasons from the SHI arm. 23 subjects continued onto the placebo/SHI. 1 subject withdrew from that arm. From there,11 subjects received drug and 11 remained on placebo|||participants|||Number
1240768|NCT00576927|Secondary|Sleep Efficiency|% of time asleep holding time in bed constant (averaged over 3-5 nights)|All Assessment Phases, up to one week|Per protocol -- intention to treat - ITT - last carried forward.|||percentage of sleep||Standard Deviation|Mean
1240769|NCT00576901|Secondary|Percentage of Participants Undergoing Breast-Conserving Surgery|The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles.|Following Cycle 6|ITT population.|||percentage of participants|||Number
1240770|NCT00576901|Secondary|Overall Survival|Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.|Cycles 1-6|The application of a statistical model for the analysis of disease-free survival is not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.||||||
1240771|NCT00576901|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first.|Cycles 1-6|The application of a statistical model for the analysis of disease-free survival was not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.||||||
1240772|NCT00576901|Secondary|Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)|The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Day 1 of Cycles 1-6|ER population|||percentage of participants|||Number
1240773|NCT00576901|Primary|Percentage of Participants Achieving Pathological Complete Response (pCR)|pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.|At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)|Evaluable Response (ER) Population: study-eligible participants who completed at least 2 treatment cycles; had lesions evaluated using the same technique at baseline and at least once after receiving the second treatment cycle; and had no major protocol deviation.|||percentage of participants|||Number
1240774|NCT00576823|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes||52 weeks (efficacy and extension study phases)|The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received).|||participants|||Number
1240775|NCT00576823|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|"When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.~A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism."|12 weeks (efficacy study phase)|The analysis was performed on the ITT population (i.e. all included patients who received at least one dose of Alfuzosin).|||participants|||Number
1240776|NCT00576823|Primary|Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis|"Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point.~'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for the affected kidney without worsening of the other kidney.~'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for one kidney without worsening of the other kidney."|baseline and 12 weeks (efficacy study phase)|The analysis was on the intent-to-treat (ITT) population (i.e. all included patients who received at least one dose of Alfuzosin) excluding the patients who didn't have baseline SFU grade. Patients without post-baseline SFU grade before Week 12 were included as non-responders.|||participants|||Number
1240777|NCT00576758|Secondary|Number of Participants With Human Anti-Human Antibodies (HAHA)|Blood was collected on Day 1 pre-infusion, during the safety follow-up for those patients who did not enter the Extension period and 6 months after the last infusion of the Extension Period if applicable. Blood was sent to a central laboratory and was tested for anti-obinutuzumab antibodies using a validated enzyme-linked immunosorbent assay (ELISA). HAHA samples were not collected for participants randomized to the rituximab arm.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Safety Population included all randomized participants who received study drug.|||Participants|||Number
1240879|NCT00576420|Secondary|Vital Signs: Respiratory Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||Breaths/ minute||Full Range|Median
1243704|NCT00554801|Primary|Audiological Test Results|Audiometric testing, with normal hearing specified as better (lower) than 25 decibels Hearing Level (dBHL), and a mild hearing loss between 25 to 50 dBHL.|three years||||decibels Hearing Level||Standard Deviation|Mean
1240778|NCT00576758|Secondary|Number of Participants With Human Anti-Chimeric Antibodies (HACA)|Blood was collected on Day 1 and was sent to a central laboratory for analysis of human anti-chimeric antibodies (anti-rituximab antibodies) using a validated enzyme-linked immunosorbent assay (ELISA). HACA samples were not collected for participants randomized to the rituximab arm.|Day 1|Participants from the Safety Population, all randomized participants who received study drug, who had samples available for HACA analysis.|||Participants|||Number
1240779|NCT00576758|Secondary|Number of Participants With Infusion Related Reactions|Infusion Related Reactions were AEs that occurred during the infusion or within 24 hours of the infusion.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Safety Population included all randomized participants who received at least once dose of study drug.|||Participants|||Number
1240780|NCT00576758|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory result), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) [Includes all AEs reported 28 days after last dose and all Related SAEs regardless of time of last dose.]|Safety Population included all randomized participants who received study drug.|||Participants|||Number
1240781|NCT00576758|Secondary|Number of Participants With Peripheral Blood B-Cell Recovery|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as the time point when the CD-19 values return to ≥ 50% of baseline levels. The number of participants with B-cell recovery from End of Induction (treatment) Phase to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) or Recovery without PD. PD required one of the following: 50 % increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50 % increase in the longest diameter of any previous site of lymphadenopathy, 50 % increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.|End of last dose + 6 Months Follow-Up|Participants from the Safety Population, all randomized participants who received study drug, with previous B-Cell Depletion and B-Cell assessment at 6 Month Follow-up.|||Participants|||Number
1240782|NCT00576758|Secondary|Number of Participants With Peripheral Blood B-Cell Depletion|Blood was collected and sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry at the end of the induction period. B-cell depletion was defined as a CD19 result 5 % of the Baseline value after at least one dose of study drug was administered.|Day 22|Participants from the Safety Population, all randomized participants who received study drug, with data available for analysis.|||Participants|||Number
1240783|NCT00576758|Secondary|Obinutuzumab Trough Serum Concentration (Ctrough)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Ctrough was calculated in micrograms/milliliter (μg/mL).|Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||μg/mL||Standard Deviation|Mean
1240784|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve Between Dosing Interval (AUCtau)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUCtau was calculated in days* micrograms/milliliter (μg/mL)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||day*μg/mL||Standard Deviation|Mean
1240785|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Volume of Distribution at Steady-State (Vss)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss was calculated in liters (L).|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||Liter||Standard Deviation|Mean
1240786|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Clearance at Steady-State (CLss)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLsst was calculated in milliliter/day (mL/day)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||mL/day||Standard Deviation|Mean
1240787|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve (AUClast)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUClast was calculated in days* micrograms/milliliter (μg/mL)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||day*μg/mL||Standard Deviation|Mean
1240788|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Maximum Serum Concentration (Cmax)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 1, 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was calculated in micrograms/milliliter (μg/mL).|Day 1 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours post-infusion), Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||μg/mL||Standard Deviation|Mean
1240789|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Terminal Half-Life (t1/2)|Blood was collected for Pharmacokinetic (PK) Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Terminal Half-Life was calculated in days.|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||days||Standard Deviation|Mean
1240790|NCT00576758|Secondary|Duration of Response|"Duration of Response was defined as the date the response, either Complete Response (CR) or Partial Response (PR), was first recorded until the date of Disease Progression or death due to any cause. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.~Disease Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the ITT population (all randomized participants with follicular NHL at the time of diagnosis N=75/74] with response. Patients with no documented progression after CR or PR will be censored at the last tumor assessment. If no assessment available patients will be censored at the first study drug.|||Months||95% Confidence Interval|Median
1240791|NCT00576758|Secondary|Percentage of Participants With Event Free Survival (EFS) Events|"Percentage of participants with Event Free Events: disease progression/relapse, death, or start of a new anti-leukemic therapy.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants|||Number
1240792|NCT00576758|Secondary|Event Free Survival|"Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|ITT population included all randomized participants with follicular non-Hodgkin's lymphoma at the time of diagnosis. If no EFS event occurred, EFS was censored at the date of the last tumor assessment. If no tumor assessment is available patient was censored at the date of the first study drug administration.|||Days||95% Confidence Interval|Median
1240793|NCT00576758|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Events|"The percentage of participants with progression, relapse, or death events from any cause as assessed by the Investigator.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the ITT population (all randomized participants) with follicular non-Hodgkin's lymphoma at the time of diagnosis. If event did not occur, PFS was censored at the date of the last tumor assessment. If no tumor assessment is available patient was censored at the date of the first study drug administration.|||Percentage of participants|||Number
1240794|NCT00576758|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the Investigator.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|ITT population included all randomized participants with follicular non-Hodgkin's lymphoma at the time of diagnosis. If no PFS even occurred, PFS was censored at the date of the last tumor assessment. If no tumor assessment was available patient was censored at the date of the first study drug administration.|||Days||95% Confidence Interval|Median
1240880|NCT00576420|Secondary|Percent Change in Vital Signs: Heart Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set|||percent change||Full Range|Median
1240795|NCT00576758|Secondary|Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants||95% Confidence Interval|Number
1240796|NCT00576758|Secondary|Number of Participants With Improved Overall Response During the Extended Treatment Period|Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis who received treatment in the extension period.|||Participants|||Number
1240797|NCT00576758|Secondary|Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants||95% Confidence Interval|Number
1240798|NCT00576758|Secondary|Percentage of Participants With Partial Response (PR) at the End of the Induction Period|Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants||95% Confidence Interval|Number
1240799|NCT00576758|Secondary|Percentage of Participants With Complete Response at the End of the Induction Period|Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. CR is defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL. All lymph nodes and nodal masses must have regressed to normal size. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Other organs considered to be enlarged before therapy due to involvement by lymphoma, such as liver and kidneys, must have decreased in size. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site.|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants||95% Confidence Interval|Number
1240800|NCT00576758|Primary|Percentage of Participants With Overall Response At the End of Induction Period|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigator at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to clinical cutoff: 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants|||Number
1240812|NCT00576628|Secondary|Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count|The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||10^9 cells/liter||Standard Deviation|Mean
1240801|NCT00576732|Secondary|Change in Insulin Resistance (IR) at 6 Months|Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1) formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.|Baseline and 6 months|All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.|||units on a scale||Standard Deviation|Mean
1240802|NCT00576732|Secondary|Change in Fasting Glucose (mg/dL) at 6 Months||Baseline and 6 months|All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.|||mg/dL||Standard Deviation|Mean
1240803|NCT00576732|Secondary|Change in Insulin Resistance (IR) at 6 Weeks|Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1)formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.|Baseline and 6 weeks|All randomized subjects with >=1 dose of study medication and fasting glucose and insulin at baseline and at >=1 postbaseline time point. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period. Means are adjusted for baseline weight (<45 kg, >=45 kg) and baseline IR.|||units on a scale||95% Confidence Interval|Least Squares Mean
1240804|NCT00576732|Secondary|Change in Fasting Glucose (mg/dL) at 6 Weeks||Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline fasting laboratory samples. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||mg/dL||Standard Deviation|Mean
1240805|NCT00576732|Secondary|Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.|"Investigator impression of change over time from double-blind baseline on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse)."|6 weeks|All randomized subjects with at least one dose of study medication and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||participants|||Number
1240806|NCT00576732|Secondary|Change in Clinical Global Impression Severity (CGI-S)|"Investigator evaluation of severity of illness and functional impairment on a 7-point scale (1=not ill, 2=very mild, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe)."|Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||units on a scale||Standard Deviation|Mean
1240807|NCT00576732|Secondary|Number of Participants Who Had at Least 25% Improvement in ABC-I|ABC-I is a measure of irritability symptoms of autism with score range 0 to 45 (lower score = lesser severity).|6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||participants|||Number
1240808|NCT00576732|Primary|Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale|Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).|Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||units on a scale||Standard Deviation|Mean
1240809|NCT00576693|Primary|Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment.|Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment OR any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up, OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up.|Mean length of follow-up was 2.4 years|All patients enrolled in the study were included in the primary outcome analysis.|||participants|||Number
1240810|NCT00576628|Secondary|The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period|The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.|From Week 29 to Week 36 (EEP)|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||participants|||Number
1240811|NCT00576628|Secondary|Mean Values of Laboratory Parameters: Transferrin Saturation|The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||percentage of saturation||Standard Deviation|Mean
1240813|NCT00576628|Secondary|Mean Values of Laboratory Parameter: Ferritin Concentration|The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||micrograms per liter||Standard Deviation|Mean
1240814|NCT00576628|Secondary|Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration|The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||grams per liter||Standard Deviation|Mean
1240815|NCT00576628|Secondary|Mean Values of Laboratory Parameter: C Reactive Protein|The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.|||milligrams per liter||Standard Deviation|Mean
1240816|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Serum Creatinine|The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.|Baseline (Week 0), and Week 32|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||micromoles/liter||Standard Deviation|Mean
1240817|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity|The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||micromoles/liter||Standard Deviation|Mean
1240818|NCT00576628|Secondary|Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration|The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||millimoles per litre||Standard Deviation|Mean
1240819|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Hematocrit|Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.|||fraction||Standard Deviation|Mean
1240820|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Hb Concentration|The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.|||g/dL||Standard Deviation|Mean
1240821|NCT00576628|Secondary|Number of Participants With Red Blood Cells Transfusions.|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.|Up to Week 52|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.|||participants|||Number
1240822|NCT00576628|Secondary|Time to Achievement of Response During the Efficacy Evaluation Period|The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||days||Standard Deviation|Mean
1240823|NCT00576628|Secondary|The Number of Participants Who Required Dose Adjustments During the Dose Titration Period|The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.|From Week 0 to Week 28 (DTP)|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||participants|||Number
1240824|NCT00576628|Secondary|Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period|The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||days||Standard Deviation|Mean
1240825|NCT00576628|Secondary|Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP|Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||percentage of participants||95% Confidence Interval|Number
1240826|NCT00576628|Primary|Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period|The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.|Baseline (Week 0) and from Week 29 to Week 36|The primary analysis was performed on per protocol (PP) population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||g/dL||Standard Deviation|Mean
1240827|NCT00576576|Secondary|Change in Fibrous Plaque Volume|Change in fibrous plaque volume between baseline and follow-up. This was derived by subtracting the baseline value from the 6-month value.|6 months|All enrolled patients with complete data set|||mm^3||Inter-Quartile Range|Median
1240828|NCT00576576|Secondary|Change in Atheroma Volume|Change in atheroma volume between baseline and follow-up is reported. This was derived by subtracting the baseline value from the 6-month value.|6 months|All enrolled patients with complete data set|||mm^3||Inter-Quartile Range|Median
1240829|NCT00576576|Primary|Change in Necrotic Core Volume|Virtual Histology-Intravascular Ultrasound (VH-IVUS) defined necrotic core cross sectional area (CSA) measured in each VH-IVUS frame and averaged over length of studied vessel at baseline and follow -up. Change in necrotic core CSA between baseline and follow-up was calculated (subtracting the baseline value from the follow-up value).|6 months|All enrolled patients with complete data set|||mm^2||Standard Deviation|Mean
1240830|NCT00576524|Secondary|Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.||6 weeks|Data not analyzed - study closed due to lack of recruitment||||||
1240831|NCT00576524|Secondary|Extra Days to Achieve Target Dry Weight|Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight|6 weeks|Data not analyzed - study closed due to lack of recruitment||||||
1240832|NCT00576524|Primary|Fluid Removal|Fluid removed as percentage of dry body weight.|6 weeks|Data not analyzed - study closed due to lack of recruitment||||||
1240833|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Interference Score have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
1240834|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Ink Color Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
1240865|NCT00576472|Primary|Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors|To compare the white matter volume of Acute Lymphoblastic Leukemia (ALL) patients with those of patients with malignant brain tumors using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images.|||percentage||95% Confidence Interval|Mean
1240881|NCT00576420|Secondary|Vital Signs: Heart Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||Heart beats/ minute||Full Range|Median
1240835|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Color Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
1240836|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Word Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
1240837|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Long Delay Free Recall has a mean of 0 and a standard deviation of 1.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated Z Score||Standard Error|Mean
1240838|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Short Delay Free Recall has a mean of 0 and a standard deviation of 1.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated Z Score||Standard Error|Mean
1240839|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Trials 1-5 have a mean T Score of 50 and Standard Deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
1240840|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Beta (Risk Taking).|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D′ and β are derived variables from signal detection theory. β is a measure of response tendency; higher scores indicate a more conservative response pattern. β was calculated using the formula = –d′*.5*(NORMSINV(hits)-NORMSINV(false alarms)). In the case where the false alarm rate = 0 or the hit rate = 1.0, we used the standard correction of 1/2N and 1- 1/2N, respectively.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
1240841|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d’ (Sensitivity).|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D′ and β are derived variables from signal detection theory. D′ is a measure of sensitivity of a person to the signal or target; a higher score is indicative of better performance or better sustained attention. D′ was calculated as z(hit) – z(commission). Z-scores were calculated using the NORMSINV function in Microsoft Excel.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
1240842|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Hit Reaction Time.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Hit reaction time is average reaction time in milliseconds for all correct responses when targets were presented. There is no pre-defined range for reaction time; higher score is indicative of slower processing speed.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
1240843|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Commission errors are the raw score for the numbers of nontargets presented where the subject incorrectly responded. Accordingly, the range for this variable is 0-6 with a higher score indicative of worse performance or impulsivity.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
1240844|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Omission Errors.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Omission errors are the raw score for the number of targets presented where the subject did not respond. Accordingly, the range for this variable is 0-54 with a higher score indicative of worse performance or problems with sustained attention.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
1240845|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Problem Behavior.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated Standard Score||Standard Error|Mean
1240846|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Social Skill.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated Standard Score||Standard Error|Mean
1240866|NCT00576472|Primary|Brain White Matter Volume for Patients Versus Sibling Controls|To compare the white matter volume of patients with those of sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had evaluable MRI images.|||percentage||95% Confidence Interval|Mean
1240847|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Problem Behavior.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated Standard Score||Standard Error|Mean
1240848|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Social Skill.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated Standard Score||Standard Error|Mean
1240849|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) ADHD Index.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
1240850|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Hyperactivity Scale.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
1240851|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
1240867|NCT00576420|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
1240868|NCT00576420|Secondary|Laboratory Values Over Time: International Normalized Ratio (INR)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||ratio||Full Range|Median
1240852|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) ADHD Index.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
1240853|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Hyperactivity Scale.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
1240854|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
1240855|NCT00576472|Secondary|Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase.|The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were done weekly during the 3-week Home Crossover Period with the best response being used as the measurement for the test.|weekly during 3-week home crossover phase|There were 122 patients treated in the home crossover period. Some patients had missing treatments and outcome assessments. A crossover design was used for better efficiency of test and better precision of estimation.|||T score||95% Confidence Interval|Mean
1240856|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Math Composite score assesses the child’s ability to solve calculation problems (Numerical Operations) and solve applied, word problems (Math Reasoning). Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and after completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score System. 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
1240857|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Spelling score assesses the child’s ability to spell words to dictation. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and after completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score System and 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
1240869|NCT00576420|Secondary|Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||seconds||Full Range|Median
1240870|NCT00576420|Secondary|Laboratory Values Over Time: Aspartate Aminotransferase (AST)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||U/L||Full Range|Median
1240871|NCT00576420|Secondary|Laboratory Values Over Time: Alanine Aminotransferase (ALT)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||U/L||Full Range|Median
1240858|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Reading Composite consists of Basic Reading (single word reading) and Reading Comprehension. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) REading: Composite Standard Score questionnaire and 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
1240859|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P)|The Social Skills Rating System- Parent Version (SSRS-P) is a parent rating scale of social behaviors in reference to typically developing children. Thirty eight questions are rated 0 (Never) to 3 (very often). The social skills score is norm-referenced with a mean of 100±15 where a higher score is indicative of better skills. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System (SSRS-P) and 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
1240860|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Score Questionnaire and 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
1240861|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months.|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Score Questionnaire and 68 were screen at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
1240862|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screened at completion. 47 patients were analyzed.|||T-score||95% Confidence Interval|Mean
1240863|NCT00576472|Primary|Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Methylphenidate (MPH) Home Maintenance Phase(baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months.|From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screen at completion. 47 patients were analyzed.|||T-score||95% Confidence Interval|Mean
1240864|NCT00576472|Primary|Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls|To compare the white matter volume of patients by treatment intensity groups (mild, moderate, and high) and sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had an evaluable MRI image.|||percentage||95% Confidence Interval|Mean
1240872|NCT00576420|Secondary|Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||mg/dL||Full Range|Median
1240873|NCT00576420|Secondary|Laboratory Values Over Time: Platelets||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||x10^3/µl||Full Range|Median
1240882|NCT00576420|Secondary|Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure|Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline – Intraoperative Day 0; Preoperative Baseline – Postoperative Day 1; and Preoperative Baseline – Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set|||percent change||Full Range|Median
1240883|NCT00576420|Secondary|Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||mm Hg||Full Range|Median
1240884|NCT00576420|Secondary|Percentage of Participants With Infections at the Surgical Site||Day 0 (procedure day) through day 30 ± 5|Safety Analysis Set|||percentage of participants||90% Confidence Interval|Number
1240885|NCT00576420|Secondary|Percentage of Participants With Graft Occlusions|Determined clinically and defined as absence of blood flow through the graft.|Day 0 (procedure day) through day 30 ± 5|Safety Analysis Set|||percentage of participants||90% Confidence Interval|Number
1240886|NCT00576420|Secondary|Percentage of Participants With Any Transfusion Requirement|Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)|Intraoperative (day 0) through day 30 ± 5|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
1240887|NCT00576420|Secondary|Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line|Any rebleeding requiring surgical reexploration|Postoperative through day 30 ± 5|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
1240888|NCT00576420|Secondary|Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line|Intraoperative rebleeding at the study suture line after occurrence of hemostasis.|Intraoperative day 0|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
1240889|NCT00576420|Secondary|Percentage of Participants Achieving Hemostasis at 10 Minutes|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|10 minutes post start of treatment application|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
1240890|NCT00576420|Secondary|Percentage of Participants Achieving Hemostasis at 6 Minutes|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|6 minutes post start of treatment application start|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
1240891|NCT00576420|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Moderate bleeding defined as:~Either >25% of the suture line bleeds, or~≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or~1 pulsatile suture line bleeding was present.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
1240892|NCT00576420|Primary|90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line|"Hemostasis at the study suture line must be maintained until closure of the surgical wound.~Participants were considered treatment failures if they met any of the following conditions:~Did not achieve hemostasis at 4 minutes~Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period~Experienced rebleeding after the first 4 minutes of the observation period."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
1240893|NCT00576420|Primary|Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.|"Hemostasis at the study suture line must be maintained.~Participants were considered treatment failures if they met any of the following conditions:~Did not achieve hemostasis at 4 minutes~Required additional hemostatic treatment during the first 4 minutes of the observation period~Experienced rebleeding after the first 4 minutes of the observation period."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants|||Number
1240894|NCT00576381|Primary|PK Profile of Dexmedetomidine|This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.|A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs)|Based on an estimated inter-subject variability of 50% for clearance, a sample size of 32 evaluable subjects will be sufficient to detect an 18% difference (alpha 0.05, power 0.9) in the clearance in this population (38 + 18 L/hr) versus that previously reported in the adult population (46 L/hr).|||mL/min||Standard Error|Least Squares Mean
1240895|NCT00576316|Secondary|Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART|Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms|6 months after each patient was initially treated with Symbicort SMART|201 participants were recruited but statistical analysis was completed for 195 participants|||scores on a scale||Standard Deviation|Mean
1240896|NCT00576316|Primary|Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART|Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction|6 months after each patient was initially treated with Symbicort SMART|201 participants were recruited but statistical analysis was completed for 195 participants|||Scores on a scale||Standard Deviation|Mean
1241589|NCT00569803|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported.|Days 1 and 116|All treated participants|||participants|||Number
1240897|NCT00576303|Secondary|Number of Participants With Red Blood Cell Transfusion|The number of participants who underwent red blood cell transfusion was reported|Up to 3 years|The safety population was defined as all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.|||number of participants|||Number
1240898|NCT00576303|Secondary|Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP|The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. . Data for the participants present at the time of assessment was used for analysis i.e. for DTP- 199, EEP-183, LTSP-178 respectively.|||number of participants|||Number
1240899|NCT00576303|Secondary|Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP|The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. Of the 199 participants, analysis was conducted on 184 participants, as 15 participants did not maintain their hemoglobin, within range of 10.5-12.5 g/dL during the EEP.|||number of days||Standard Deviation|Mean
1240900|NCT00576303|Secondary|Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP|All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available.|||percentage of participants||95% Confidence Interval|Number
1240901|NCT00576303|Secondary|Mean Change in Hb Concentration From Baseline to the EEP|A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24|Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)|The Intent-to-Treat (ITT) population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available.|||g/dL||Standard Deviation|Mean
1240902|NCT00576303|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP|All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|Per protocol (PP) population included participants except who didn’t meet inclusion criterion relative to consent, stable baseline Hb values, iron status, epoetin maintenance, and who met exclusion criterion of hemoglobinopathies/hemolysis, bleeding, >3 recorded Hb, missing drug administration, other ESA, blood transfusion during the DTP or EEP.|||percentage of participants||95% Confidence Interval|Number
1240903|NCT00576251|Primary|Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)|Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.|Day 4 - Test Of Cure (TOC) compared to Day 0||||Percent of patients|||Number
1240904|NCT00576199|Secondary|Tumor Necrosis|Tumor necrosis was quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area was measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation in tumor after TACE was regarded as an indication of necrosis. Tumor necrosis was assessed at Baseline and 1 week prior to the next scheduled transarterial chemoembolisation (TACE) for the first 4 TACEs, then 1 week prior to every second TACE till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Percentage of tumor volume at Baseline||Standard Deviation|Mean
1240905|NCT00576199|Secondary|Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease|A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the Baseline sum LD. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the LD) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the LD for all target lesions will be calculated and reported as the Baseline sum LD.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Percentage of participants||95% Confidence Interval|Number
1240906|NCT00576199|Secondary|Overall Survival|Overall survival was defined as the time from the first administration of study drug to death.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Months||95% Confidence Interval|Median
1240907|NCT00576199|Secondary|Time to Progression|Time to progression was defined as the time from the first administration of study drug to the first documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Months||95% Confidence Interval|Median
1240908|NCT00576199|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete response or a partial response. A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Percentage of participants||95% Confidence Interval|Number
1240909|NCT00576199|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Months||95% Confidence Interval|Median
1240910|NCT00576147|Primary|1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma.|"We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain.~Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements."|2 years|431 Total patients enrolled; 365 total patients evaluated after 66 excluded for protocol violations; 269 Number of patients with no Intracranial Hemorrhage; 96 Number of patients with confirmed intrcranial hemorrhage; 50 Number of patients with Intracranial hemorrhage within detection limits of the device.|||Number of participants|||Number
1240911|NCT00576056|Secondary|Determine the Overall Survival in Patients Treated With This Combination Regimen|Overall survival (OS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of death. For a surviving patient, OS is censored by the last follow-up date when that patient is documented to be alive.|From date of initial treatment until the date of death from any cause|Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).|||days||Full Range|Median
1240912|NCT00576056|Primary|Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality|Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|Up to 24 months (from initial treatment through 12 months follow-up)|Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).|||days||Full Range|Median
1240913|NCT00575965|Primary|Progression-Free Survival|Progression-free survival is the defined as the time from study entry to disease progression (PD) or death based on Kaplan-Meier estimates. Patients alibe without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s). [Consensus panel criteria: Weber et al, 2003; Kimby et al, 2005].|Assessed at month 1 and 3 and thereafter every 3 months while on therapy; Assessed every 6 months for up to 2 years of follow-up. Median follow-up in this study cohort was 6 months (range 2-18 months).|The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.|||months||95% Confidence Interval|Median
1240937|NCT00575588|Secondary|Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c|Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.|Week 24 to Week 52|Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations|||Percent||Standard Error|Mean
1240914|NCT00575965|Primary|Objective Response Rate|Objective response is defined as achieving partial response or better on therapy based on the Consensus Panel Recommendations from the 2nd and 3rd International Workshop on WM [Weber et al, 2003; Kimby et al, 2005]. Complete Response (CR): Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. Partial Response (PR): a >=50% reduction from baseline in the SM IgM concentration. Minor Response (MR): >=25%, but a <50% reduction of SM IgM from baseline.|Assessed at month 1 and 3 and thereafter every 3 months while on therapy. Median duration on treatment was 6 months (range 1-24 months).|The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.|||proportion of patients|||Number
1240915|NCT00575887|Primary|Progression-free Survival at 6-months||Until progression||||percentage of participants|||Number
1240916|NCT00575666|Primary|Psychopathology- QLS Total|Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
1240917|NCT00575666|Primary|Psychopathology- CDSS Total|Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
1240918|NCT00575666|Primary|Psychopathology- SANS Total|Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
1240919|NCT00575666|Primary|Psychopathology- PANSS General Psychopathology|General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
1240920|NCT00575666|Primary|Psychopathology- PANSS Negative|Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
1240921|NCT00575666|Primary|Psychopathology- PANSS Positive|Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
1240922|NCT00575666|Primary|Psychopathology- PANSS Total|Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
1240923|NCT00575666|Primary|Cognitive Function- CPT False-alarm Rate (Proportion)|Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Proportion of total hits||Standard Deviation|Mean
1240924|NCT00575666|Primary|Cognitive Function- CPT Reaction Time of Hits (Milliseconds)|"Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure (CPT d prime score). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Milliseconds||Standard Deviation|Mean
1240967|NCT00575159|Primary|Change From Baseline Vital Signs: Heart Rate|Heart rate was obtained during each treatment period at indicated time points. Measurements were made with the participants lying semi-recumbent having rested in this position for at least 10 minutes before the initial reading.|Day 1 of each treatment period|Safety Population|||beats/minute||Standard Deviation|Mean
1240925|NCT00575666|Primary|Cognitive Function- CPT Hits Rate (Proportion)|"Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure (CPT d prime score). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Proportion of total hits||Standard Deviation|Mean
1240926|NCT00575666|Primary|Cognitive Function- CPT D Prime Score|"Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance. Higher scores represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||D prime score||Standard Deviation|Mean
1240927|NCT00575666|Primary|Cognitive Function- Trails B|"Subjects completed a timed trails (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Seconds||Standard Deviation|Mean
1240928|NCT00575666|Primary|Cognitive Function- Trails A|"Subjects completed a timed trails (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Seconds||Standard Deviation|Mean
1240929|NCT00575666|Primary|Cognitive Function- HVLT Delayed Recall Total|Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Words correct||Standard Deviation|Mean
1240930|NCT00575666|Primary|Cognitive Function- HVLT Immediate Recall Total|Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Words correct||Standard Deviation|Mean
1240931|NCT00575666|Primary|Cognitive Function- Verbal Fluency|Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Words correct||Standard Deviation|Mean
1240932|NCT00575666|Primary|Cognitive Function- Digit Span Total|Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Items correct||Standard Deviation|Mean
1240933|NCT00575588|Other Pre-specified|Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c|Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.|Week 24 to Week 104||||Percent||Standard Error|Mean
1240934|NCT00575588|Other Pre-specified|Body Weight Change From Baseline to Week 104|Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.|Baseline, Week 104|Number of subjects with observed values at Week 104 was n=186 for saxagliptin + metformin and n=165 for glipizide + metformin|||kilograms||Standard Error|Mean
1240935|NCT00575588|Other Pre-specified|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks|Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)|Baseline, Week 104||||Percentage of Participants|||Number
1240936|NCT00575588|Other Pre-specified|Hemoglobin A1c (HbA1c) Change From Baseline to Week 104|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.|Baseline, Week 104|Number of subjects with observed values at Week 104 was n=184 for saxagliptin + metformin and n=160 for glipizide + metformin|||Percent||Standard Error|Mean
1240938|NCT00575588|Secondary|Body Weight Change From Baseline to Week 52|Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.|Baseline, Week 52 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement|||kilogram||Standard Error|Mean
1240939|NCT00575588|Secondary|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks|Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)|From Baseline to Week 52||||Percentage of Participants|||Number
1240940|NCT00575588|Primary|Hemoglobin A1c (HbA1c) Change From Baseline to Week 52|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.|Baseline to 52 Weeks|Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations|||Percent||Standard Error|Mean
1240941|NCT00575510|Secondary|State Trait Anxiety Inventory (STAI)-State Scale|State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)|+ 7-30 days post-intervention|Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions.|||units on a scale||Standard Deviation|Mean
1240942|NCT00575510|Primary|Adherence to Initial Follow-up (Yes/no)|Attendance at initial appointment to follow-up abnormal Pap test result|adherence rates at initial follow-up appointment, 2 weeks to 3 months||||percentage of patients who were adherent|||Number
1240943|NCT00575380|Secondary|Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)||Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312||||ug/mL||Standard Deviation|Mean
1240944|NCT00575380|Primary|Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)|Nominal time is scheduled time relative to administration of the first eye drop|Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312||||ug/g||Standard Deviation|Mean
1240945|NCT00575367|Primary|Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.||15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours|Per Protocol Population|||µg/mL||Standard Deviation|Mean
1240946|NCT00575185|Secondary|Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability|Assessing adverse events in participants to see if this drug causes more or less side effects|15 days||||participants|||Number
1240947|NCT00575185|Primary|Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline|All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline|21 days||||participants|||Number
1240948|NCT00575159|Secondary|The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK279782 Over Period|Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK279782|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Pharmacokinetic (PK) Parameter Population comprised of all participants for whom pharmacokinetic parameter estimates were derived during any treatment period|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1240949|NCT00575159|Secondary|The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK189074 Over Period|Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK189074|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1240950|NCT00575159|Secondary|Oral Clearance (CL/F) Over Period|Oral clearance is a measure of the rate at which the drug is cleared from the body via metabolism. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1240951|NCT00575159|Secondary|AUC From Time Zero to 4 Hours Post Dose, AUC(0-4) for GSK189074 Over Period|AUC(0-4) was defined as AUC from time zero to 4 hours post dose. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1240952|NCT00575159|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) and Terminal Half Life, (T1/2) of GSK189075 Over Period|Tmax was defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. T1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples obtained during indicated time points. T1/2 was calculated as t1/2 = ln2/λz, with λz (the terminal elimination rate-constant) estimated from log-linear regression analysis of the terminal phase of the plasma concentration-time profile.Tmax and t1/2 values for GSK189075 were presented.|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population. Only those participants available at specified time points were analyzed.|||hour||Geometric Coefficient of Variation|Geometric Mean
1241100|NCT00573937|Primary|Change in Numeric Pain Scale Score|Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain. Response to treatment is defined as a 33% reduction in pain score from the baseline to the Week 4 pain score.|Baseline, Week 4|Due to slow accrual, the study was terminated and no data were analyzed.||||||
1240953|NCT00575159|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK189075 Over Period|Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Geometric Means with respective Geometric Coefficient of Variation (% CV).|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1240954|NCT00575159|Secondary|Area Under the Plasma Concentration vs. Time Curve (AUC) From Time Zero (Time of Dosing) to the Last Time Point With Measurable Analyte Concentration, AUC(0-last), AUC From Time Zero to Infinite Time, AUC(0-inf) of GSK189075 Over Period|AUC(0-last) was defined as area under the plasma concentration vs. time curve from time zero (time of dosing) to the last time point with measurable analyte concentration and AUC(0-inf) was defined as area under the plasma concentration vs. time curve from time zero to infinite time. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||hour*nanograms per milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1240955|NCT00575159|Secondary|Mean Creatinine Clearance 0-24 H|Urine samples for calculating creatinine clearance were obtained over the intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. Mean creatinine clearance over 0-24 H was presented.|Day 1 of each treatment period|Safety Population|||mL/min||Standard Deviation|Mean
1240956|NCT00575159|Secondary|Mean Total Urine Volume 0-24 H|Urine volume was recorded over intervals : 0-4h, 4-8h, 8-12h, 12-16h and 16- 24h on Day 1 for each dosing period. Mean total Urine volume over 24 hours was presented.|Day 1 of each treatment period|Safety Population|||mL||Standard Deviation|Mean
1240957|NCT00575159|Secondary|Percent of Filtered Glucose in the Urine.|Filtered glucose in the urine was assessed at indicated time points and was presented as Percentage. The 0-12h and 0-24h amounts Percent of filtered glucose in the urine were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period.|Safety Population|||Percentage||Standard Deviation|Mean
1240958|NCT00575159|Secondary|Urinary Glucose Excretion (UGE) for Timed Subintervals up to 24 Hours Post Dose (0-24 H)|UGE was assessed for timed subintervals up to 24h post-dose. Urine samples were collected at intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h on study days. The 0-24h amounts excreted in urine were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period|Safety Population|||mmol||Standard Deviation|Mean
1240959|NCT00575159|Secondary|Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1|AUC(0-10) was the plasma glucose weighted mean AUC for 0 to 10 h post-dosing and AUC(0-4) was the plasma glucose weighted mean AUC for 0 to 4 h post-dosing. Incremental Adjusted Weighted Means were presented.|Up to 24 hours post dose of each treatment period.|Safety Population|||mmol/L||Standard Deviation|Mean
1240960|NCT00575159|Primary|Mean of Derived Plasma Glucose Parameters|The plasma measurements at specified time points on Day 1 were collected. Derived plasma glucose parameters were presented.|Up to 24 hours post dose of each treatment period.|Safety Population.|||mmol/L||Standard Deviation|Mean
1240961|NCT00575159|Primary|Summary of Fluid Balance|On Day 1, fluid intake, urine volume and number of micturations were recorded over the intervals for each of the following dosing periods: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. From these measures, fluid balance was calculated over the 24-hour period. Fluid Balance=total fluid intake minus total urine volume. The 0-24h amounts of total Fluid Intake, total urine output, and fluid balance were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period.|Safety Population.|||Milliliters (mL)||Standard Deviation|Mean
1240962|NCT00575159|Primary|Mean Creatinine Clearance|Creatinine clearance was calculated and reported in Milliliters per minute (mL/min) on Day 1 of each period for each collection interval 0-4, 4-8, 8-12, 12-16 and 16-24 hour, as well as the combined intervals of 0-12 and 0-24 hour. For urine measurements, participants were instructed to void within 30 minutes before administration of study medication.|Up to 24 hours post dose of each treatment period.|Safety Population. Only those participants available at the specified time points were analyzed.|||mL/min||Standard Deviation|Mean
1240963|NCT00575159|Primary|Summary of Urine Osmolality|Urine sample was collected at screening, Day –2 (18:00h) and Day 1 (7:45h) for determination of urine osmolality which was measured in Millimole per kilogram (mmol/kg).|Day 1 (pre dose) of each treatment period|Safety Population. Only those participants available at the specified time points were analyzed.|||mmol/kg||Standard Deviation|Mean
1240964|NCT00575159|Primary|Number of Participants With Abnormal Hematology Data|Data for abnormal Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red Blood Cell (RBC), Reticulocytes, Total Neutrophils, White Blood Cell (WBC) were reported. Data for number of participants with abnormal Hematology were reported.|Day 1 of each treatment period|Safety Population. Only those participants available at the specific time points were analyzed.|||Participants|||Count of Participants
1240965|NCT00575159|Primary|Number of Participants With Abnormal Clinical Chemistry Data|Clinical Chemistry data for parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Bicarbonate, Calcium, Chloride, Creatine Kinase, Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Lactate Dehydrogenase, Magnesium, Phosphorus, Potassium, Total Bilirubin, Sodium, Total protein, triglycerides and urea/BUN was reported. Data for number of participants with abnormal clinical Chemistry data was presented.|Day 1 of each treatment period|Safety Population. Only those participants available at the specific time points were analyzed.|||Participants|||Count of Participants
1240966|NCT00575159|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Standard semi-recumbent 12-lead ECG was obtained after the participant rested for a minimum of 10 minutes (If questionable abnormality was noted on the ECG, 2 more measurements were allowed to provide an average of 3 measurements). Number of participants with abnormal ECG were reported.|Day 1 of each treatment period|Safety Population|||Participants|||Count of Participants
1241101|NCT00573872|Primary|Number of Participants With Lack of Tumor Growth at Last Follow-up|Lack of tumor growth by CT or MRI at last follow-up|2 years||||Participants|||Count of Participants
1240968|NCT00575159|Primary|Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)|SBP and DBP were obtained during each treatment period at the indicated time points. Measurements were made with the participant lying semi-recumbent having rested in this position for at least 10 minute before the initial reading.|Day 1 of each treatment period|Safety Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1240969|NCT00575159|Primary|Number of Participants With Hypoglycemia Episodes/Events|A hypoglycemic event was defined as symptoms of hypoglycemia confirmed by a blood glucose value below normal limits [less than 3.89 millimoles per liter (mmol/L)] or 70 milligrams per deciliter (mg/dL). Symptoms of hypoglycemia without confirmed blood glucose values were reported as AEs instead of hypoglycemic events. Number of participants with hypoglycemic events were reported.|Day 1 of each treatment period|Safety Population|||Participants|||Count of Participants
1240970|NCT00575159|Primary|Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 6 months|Safety Population comprised of all enrolled participants who have received at least one dose of study drug were included in the safety population.|||Participants|||Count of Participants
1240971|NCT00575146|Secondary|Quality of Life||while on study treatment for up to 12 months|||||||
1240972|NCT00575146|Secondary|Ketosis||while on study treatment for up to 12 months|||||||
1240973|NCT00575146|Secondary|Frequency of Seizures||while on study treatment for up to 12 months|||||||
1240974|NCT00575146|Secondary|Overall Survival|Participants were followed until reported death or last contact until 05/2011|death/last contact, an average of about 1 year||||weeks||Full Range|Median
1240975|NCT00575146|Secondary|Progression-free-survival|measured by Macdonald-Criteria|until progression for up to 12 months|for the analyis of PFS and OS, 3 patients who discontinued the diet in the absence of progression were excluded|||weeks||Full Range|Median
1240976|NCT00575146|Primary|Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability|percentage of patients who discontinued diet due to intolerability|until progression for up to 12 months||||percent of participants|||Number
1240977|NCT00575094|Primary|Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.|Clinical response: Cure=all initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR)improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for nonstudy drug/infection reasons (eg, lost to follow-up); death ≤2 days after first dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|8 weeks|All patients who received at least one dose of study drug.|||participants|||Number
1240978|NCT00575042|Primary|Serum Level of Alkaline Phosphatase|We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.|1 year||||U/L||Full Range|Median
1240979|NCT00575029|Primary|Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function|the number of weeks required for participants to recover from adrenal suppression as assessed by a normal ACTH stimulation test (cortisol level >21 mcg/dl)|weekly for up to 6 weeks||||weeks|||Number
1240980|NCT00575029|Primary|Number of Participants With Adrenal Insufficiency|Number of participants with adrenal insufficiency after treatment with megestrol acetate assessed by ACTH stimulated cortisol levels less than normal (21 ug/dl) measured weekly for 8 weeks or when adrenal insufficiency is clinically encountered|stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered||||participants|||Number
1240981|NCT00575016|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment|||Centimeters of water (cm H2O)||Standard Deviation|Mean
1240982|NCT00575016|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment|||Milliliters (mL) of urine||Standard Deviation|Mean
1240983|NCT00575016|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment|||Number of Weekly Episodes||Standard Deviation|Mean
1240984|NCT00574990|Secondary|Overall Involvement in Conversation by Roles|The number of communication events was recorded on electronic notepads during each observation period. The communication events recorded included: a) physicians to physicians, to nurses, to pharmacists, and to patients; b) nurses to nurses, to physicians, to pharmacists, and to patients; and c) pharmacists to pharmacists, to physicians, to nurses, and to patients. The percentage of each of these types of verbal communications was calculated from the total number of communication events.|6 months||||percentage of role involvement in event|||Number
1240985|NCT00574990|Primary|Incident Rate for Communication Events|Observation periods were approximately two-hours long. Some providers were observed more than once. The number of communication events were counted per each observation period.|6 months|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.|||mean events per observation||Standard Deviation|Mean
1240986|NCT00574951|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. In this study time of progression could not be validly collected due to the study being prematurely closed, secondary to severe neurological adverse events seen in 4 patients, and thus progression-free survival (PFS) cannot be presented. For safety reasons, most patients (16/22) were taken off study drug prior to progression (or AE),|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated, up to 5 years|Study Analysis aborted due to severe toxicities. Estimates not calculated. Follow up for progression after coming off study was not collected in a manner that yields time to time to progression data.||||||
1240987|NCT00574951|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients|||Participants|||Count of Participants
1240988|NCT00574951|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
1240989|NCT00574951|Primary|Progression-free Survival (PFS) at 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. In this study, time of progression could not be validly collected due to the study being prematurely closed secondary to severe neurological adverse events seen in 4 patients,|CT scan or MRI every other cycle for the first 6 months|Time of progression could not be validly collected due to the study being prematurely closed due to severe neurological adverse events, thus 6-month PFS cannot be presented. For safety reasons, most patients (16/22) were taken off study drug prior to progression (or AE), and follow-up for progression after coming off study was not collected.||||||
1240990|NCT00574951|Primary|Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated up to 5 years.|Eligible and treated patients.|||Participants|||Count of Participants
1240991|NCT00574912|Primary|Maximum Glucose Infusion Rate|measuring the changes in glucose infusion rate during the 24 hour experimental period.|24 hours|12 participants in each arm|||umol/kg/min||Standard Error|Mean
1240992|NCT00574873|Secondary|Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks|"The cumulative incidence curve was generated based on the time from randomization to the first date of transformation to AP or BP while on study treatment adjusting for the competing risk of treatment discontinuation without transformation, for each participant.~Criteria for transformation to AP: 15 to 29% blasts; ≥30% blasts + promyelocytes; ≥20% basophils in blood or bone marrow; platelets <100*10^9/L (not related to therapy), in blood. Criteria for transformation to BP: ≥30% blasts in blood or bone marrow and extramedullary involvement other than liver or spleen (example: chloromas).~Time to transformation was calculated as weeks = ([date of first documented occurrence of the event - date of randomization] + 1)/7. If transformation was not obtained, censoring was at the last hematologic assessment or death (whichever was earliest). Participants who were not treated contributed time = 1 day/7. 95% confidence interval for the cumulative incidence is from Gray’s method."|192 weeks|ITT population|||Percentage of Participants||95% Confidence Interval|Number
1240993|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks|"The Kaplan-Meier curve was generated based on the first date of MMR until the first date loss of MMR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid molecular assessment.~Molecular response was assessed using Bcr-Abl transcript levels measured by RT-PCR from peripheral blood. MMR is defined as a ratio Bcr-Abl/Abl ≤0.1% on the international scale (≥3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Three years rate was displayed since the majority of imatinib participants had first MMR by Year 2."|144 weeks|Subgroup of participants from ITT population who had MMR.|||Percentage of Participants||95% Confidence Interval|Number
1240994|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks|"The Kaplan-Meier curve was generated based on the first date of confirmed CHR until the first date of loss of CHR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid hematologic assessment.~CHR must have been of at least 4 weeks in duration confirmed by 2 assessments at least 4 weeks apart and was defined as follows: white blood cells ≤ institutional upper limit of normal, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, absolute neutrophil count ≥1.0*10^9/L, platelets ≥100 but <450*10^9/L unless related to therapy, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly).~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CHR by Year 1."|192 weeks|Subgroup of participants from ITT population who had CHR.|||Percentage of Participants||95% Confidence Interval|Number
1240995|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks|"The Kaplan-Meier curve was generated based the time from the first date of CCyR until the first date of confirmed loss of CCyR, objectively documented, for responders only. Participants without confirmed loss of CCyR were censored at the last valid cytogenetic assessment.~CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or <1% Bcr-Abl fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CCyR by Year 1."|192 weeks|Subgroup of participants from ITT population who had CCyR.|||Percentage of Participants||95% Confidence Interval|Number
1240996|NCT00574873|Secondary|Percentage of Participants With Major Molecular Response (MMR) at Year 1|Molecular response was assessed using Bcr-Abl transcript levels measured by reverse transcriptase polymerase chain reaction (RT-PCR) from peripheral blood. A MMR was defined as a ratio Bcr-Abl/Abl less than or equal to (≤) 0.1% on the international scale (greater than or equal to [≥] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.|Year 1 (48 weeks)|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
1240997|NCT00574873|Primary|Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1|Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.|Year 1 (48 weeks)|Intent-to-treat (ITT) population - included all participants who were randomized to test article.|||Percentage of Participants||95% Confidence Interval|Number
1240998|NCT00574847|Primary|Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)|MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.|week 6|Subjects who completed.|||percentage of participants|||Number
1240999|NCT00574847|Secondary|Exercise Stressed-induced Myocardial Ischemia (ESIMI)|End point values adjusted for baseline values age and sex.|6 week|ITT, 7 subject excluded from analysis due to missing data.|||percentage of change||95% Confidence Interval|Number
1241000|NCT00574847|Secondary|Spielberger State-Trait Anxiety Inventory Scales (STAI)|STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex.|6 weeks|ITT|||units on a scale||95% Confidence Interval|Mean
1241001|NCT00574847|Secondary|Cook-Medley Hostility (Ho) Hostile Affect Sub-scale|hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex.|6 weeks|ITT, 1 subject excluded from analysis due to missing data.|||units on a scale||95% Confidence Interval|Mean
1241002|NCT00574847|Secondary|Cook-Medley Hostility (Ho) Scale|Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex.|6 weeks|ITT, 1 subject excluded from analysis due to missing data.|||units on a scale||95% Confidence Interval|Mean
1241003|NCT00574847|Secondary|Perceived Stress Scale|Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex.|6 weeks|ITT|||units on a scale||95% Confidence Interval|Mean
1241004|NCT00574847|Secondary|Platelet Serotonin Binding Affinity Kd_100|End point values adjusted for baseline values age and sex.|6 weeks|ITT, 27 subjects were excluded from analysis due to missing data.|||nM||95% Confidence Interval|Mean
1241005|NCT00574847|Secondary|5HTT, Serotonin Transporter Protein|End point values adjusted for baseline values age and sex.|week 6|ITT, 29 subjects excluded from analysis due to missing data.|||fmol/mg||95% Confidence Interval|Mean
1241006|NCT00574847|Secondary|Mental Stress Induced Change in Heart Rate|"A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs.~Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex."|baseline, 6 weeks|ITT, 10 subjects excluded from analysis due to missing data.|||beats/minute||95% Confidence Interval|Mean
1241007|NCT00574847|Secondary|Beck Depression Inventory|The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex.|6 week|ITT|||units on a scale||95% Confidence Interval|Mean
1241008|NCT00574847|Secondary|Percentage of Participants With Adverse Events||Baseline to week 6||||percentage of participants|||Number
1241009|NCT00574847|Secondary|Mental Stress Induced Change of Diastolic Blood Pressure|Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex.|Baseline, week 6|ITT, 9 subjects excluded from the analysis due to missing data.|||mm Hg||95% Confidence Interval|Mean
1241010|NCT00574847|Secondary|Mental Stress Induced Change of Systolic Blood Pressure|Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex.|Baseline, week 6|ITT, 9 subjects excluded from analysis due to missing data.|||mm Hg||95% Confidence Interval|Mean
1241011|NCT00574847|Primary|Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors|MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.|Week 6|Intent-to-treat (ITT)|||percentage of participants||95% Confidence Interval|Number
1241012|NCT00574834|Primary|Changes in Insulin Sensitivity|Measures of change in endogenous glucose production from baseline to final 30 minutes of clamp studies after 6 months of treatment.|6 months||||mg/kg/min||Standard Error|Mean
1241013|NCT00574795|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 12-15 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1241014|NCT00574795|Secondary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 12 - 15 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1241015|NCT00574795|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one mone month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1241016|NCT00574795|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1241017|NCT00574795|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1241018|NCT00574795|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1241019|NCT00574704|Secondary|Safety and Tolerability of the Study Treatment by Collection of Adverse Events||about 30 min. at each visit|||||||
1241034|NCT00574548|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1241020|NCT00574704|Primary|Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)|"The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted).~The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2."|baseline versus 2 months after baseline||||Factor of Increased Allergen Tolerance||Inter-Quartile Range|Median
1241021|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241022|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241023|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC , respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241024|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241025|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241026|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241102|NCT00573872|Primary|Assess the Acute and Late Toxicity of Spinal Radiosurgery|CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.|2 years||||events|||Number
1241027|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241028|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241029|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241030|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population includes all participants who receive at least 1 dose of study vaccine. N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1241031|NCT00574548|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1241032|NCT00574548|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 23vPS; Year 1) time points.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1241033|NCT00574548|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 13vPnC; Year 1) time points.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1241226|NCT00573131|Primary|Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT||Screening and Week 12|Subjects who received at least one treatment with OncoGel, systemic chemotherapy or external beam radiation therapy were included for analysis of efficacy.|||percentage of patients|||Number
1241035|NCT00574548|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population: participants who were eligible for the study, adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. GMTs were calculated using all participants with available data for the specified blood draw.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1241036|NCT00574405|Secondary|Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.||12 months|||||||
1241037|NCT00574405|Secondary|Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.||12 months|||||||
1241038|NCT00574405|Secondary|Changes in Daily Insulin Requirements Over Time||12 months|||||||
1241039|NCT00574405|Secondary|Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.||12 months|||||||
1241040|NCT00574405|Primary|Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.||12 months|Per protocol|||ng/mL||Standard Deviation|Mean
1241041|NCT00574340|Primary|Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2|A measure of the baseline arterial dilation on day 2 is compared to the post intervention measure of dilation of the brachial artery on Day 2.|baseline on day 2 and ~6 hours later at end of glucose clamp period|Flow mediated dilation of the brachial artery|||percentage of change||Standard Error|Mean
1241042|NCT00574288|Secondary|Part 2: Overall Survival|Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.|Approximately 3 years|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
1241043|NCT00574288|Secondary|Part 2: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Time to VGPR (very good partial response) was defined as the time from the date of first dose of daratumumab to the date of initial documentation of VGPR response. The Kaplan-Meier method was used to estimate time to response.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. Here 'n' (Number of Participants Analyzed) signifies number of participants analyzed at specific time point.|||months||Standard Deviation|Mean
1241044|NCT00574288|Secondary|Part 2: Progression-Free Survival|Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
1241045|NCT00574288|Secondary|Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier|Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.|Up to Week 27|Subset of All-Treated Analysis Set included those who had overall response in Part 2.|||months||Full Range|Median
1241046|NCT00574288|Secondary|Part 2: Time to Progression (TTP)|TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL); urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
1241047|NCT00574288|Secondary|Part 1: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Kaplan-Meier method was used to estimate the distribution of time to response and time to best response.|Up to Week 28|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with >= 4 mg/kg daratumumab were used for efficacy analyses and less than (<) 4 mg/kg doses were considered under the therapeutic levels.|||months||95% Confidence Interval|Median
1241057|NCT00574249|Secondary|Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)|Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.|Week 0 and Week 16|Of the ITT analysis set, participants with an SF-36 score at both Baseline and Week 16. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.|||percent change in score||Standard Deviation|Mean
1241344|NCT00571493|Primary|Maximum Tolerated Dose (MTD) of Bortezomib|The maximum tolerated dose (MTD) is defined to be the dose cohort below which 3 of 6 patients experience dose limiting toxicity (DLT), or the highest dose cohort of 1.5 mg/m², if 2 DLT were not observed at any dose cohort.|14 months|The MTD in Phase I was initially determined to be 1.5 mg/m2 but was later decreased to 1 mg/m2.|||mg/m²|||Number
1241048|NCT00574288|Secondary|Overall Response Rate|Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hours; PR: >= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.|Up to Week 28 (for Part 1) and Week 27 (for Part 2)|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with >= 4 mg/kg daratumumab were used for efficacy analyses and less than (<) 4 mg/kg doses were considered under the therapeutic levels.|||percentage of participants||95% Confidence Interval|Number
1241049|NCT00574288|Primary|Number of Participants With Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2)|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1241050|NCT00574275|Secondary|Number of Participants With Anti-drug Antibodies|Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. The validated lower limit of detection (LLOD) for the assay was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.|Up to 90 days post last dose of study drug|Safety population with samples available for analysis|||participants|||Number
1241051|NCT00574275|Secondary|Safety-Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the signature of informed consent until 30 days after the last administration of study treatment, were recorded. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized.|The safety population included all randomized participants who were administered at least 1 dose of study medications (placebo, aflibercept, or gemcitabine). For safety analyses, participants were analyzed according to the treatment received.|||participants|||Number
1241052|NCT00574275|Secondary|Clinical Benefit|"Clinical benefit was to be assessed in all participants by time to symptom worsening (TTSW), evaluated from the time of randomization to symptom worsening, as well as by improvement in tumor related symptoms.~However, this analysis was not performed, as the study was terminated due to futility."|From the first randomization until the end of the study data cutoff date (approximately 2 years)|Since the study was terminated due to futility, analysis for this endpoint was not performed.||||||
1241053|NCT00574275|Secondary|Objective Response Rate (ORR) Assessed by the Investigators According to RECIST Criteria|"Objective response (OR) included complete response [CR] and partial response [PR]. OR was to be assessed by the Investigators according to RECIST criteria, and confirmed by repeating tumor imaging at least 4 weeks after the first radiological documentation of response.~CR would reflect the disappearance of all tumor lesions and PR would reflect a defined reduction of tumor burden.~However, OR analysis was not performed, as the study was terminated due to futility."|From the first randomization until the end of the study data cutoff date (approximately 2 years)|Since the study was terminated due to futility, this analysis was not performed.||||||
1241054|NCT00574275|Secondary|Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria|"PFS was the time interval from the date of registration to the date of progression, or death from any cause if it occurs before tumor progression is documented. Tumor progression was assessed using RECIST criteria, by which progression was a pre-defined increase in the size of existing tumors or appearance of one or more new tumors.~If a participant did not progress or die, the progression was censored to the date of the last valid tumor assessment or data cut-off, whichever was earlier.~Median PFS time was estimated from Kaplan-Meier Plots."|From the first randomization until the end of study data cutoff date (approximately 2 years)|Intent-to-treat (ITT) population, which included all randomized participants.|||months|Participants|95% Confidence Interval|Median
1241055|NCT00574275|Primary|Overall Survival (OS)|"OS is the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, data on OS were censored at the earlier of the last date participant was known to be alive, or the study data cutoff date (11 September 2009).~OS time was estimated from Kaplan-Meier Plots."|From the first randomization until the end of study data cutoff date (approximately 2 years)|Intent-to-treat (ITT) population, which included all randomized participants.|||months|Participants|95% Confidence Interval|Median
1241056|NCT00574249|Secondary|Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)|Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.|Week 0 and Week 8|Of the ITT analysis set, participants with an SF-36 score both at Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.|||percent change in score||Standard Deviation|Mean
1241099|NCT00573937|Secondary|Change in Numeric Pain Scale Score|Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain.|48 hours|Due to slow accrual, the study was terminated and no data were analyzed.||||||
1241058|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 12|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 12. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Standard Deviation|Mean
1241059|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 8|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Standard Deviation|Mean
1241060|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 4|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 4. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.|||percent change in score||Standard Deviation|Mean
1241061|NCT00574249|Secondary|Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 2|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 2. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Standard Deviation|Mean
1241062|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 16|Of the ITT analysis set, participants with DLQI scores both at Baseline and Week 16. Imputation of missing values using last observation carried forward (LOCF). Participants with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Standard Deviation|Mean
1241063|NCT00574249|Secondary|Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 16|ITT analysis. Imputation of missing values at Week 16 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
1241064|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 12|ITT analysis. Imputation of missing values at Week 12 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
1241065|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 8|ITT analysis. Imputation of missing values at Week 8 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
1241066|NCT00574249|Other Pre-specified|Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.|NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop [salmon patch] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement.|Week 0 and Week 16|Of the ITT analysis set, participants with a NAPSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Inter-Quartile Range|Median
1241067|NCT00574249|Other Pre-specified|Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.|PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement.|Week 0 and Week 16|Of the ITT analysis set, participants with a PSSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Inter-Quartile Range|Median
1241068|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 4|ITT analysis. Imputation of missing values at Week 4 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
1241069|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 2|ITT analysis. Imputation of missing values at Week 2 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
1241070|NCT00574249|Secondary|Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)|PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.|||percentage of participants|||Number
1241071|NCT00574249|Secondary|Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.|||percentage of participants|||Number
1241072|NCT00574249|Secondary|Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)|PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.|||percentage of participants|||Number
1241073|NCT00574249|Primary|Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.|||percentage of participants|||Number
1241074|NCT00574236|Secondary|Time to Progression|Number of days to progression, where progression is defined as the number of days from the day of first study drug administration to the day the patient experiences an event of disease progression, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. If a patient has not experienced an event of disease progression, then the patient's data will be censored at the date of the last available evaluation. Progression-free survival will be summarized by medium time to progression.|Up to one year||||days to progression||Full Range|Median
1241075|NCT00574236|Primary|Overall Response Rate|"Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm."|Every two cycles/42 days, up to 7 months|Protocol accrued only 4 of 54 subjects, and was ultimately terminated. No data analysis was done.|||Participants|||Count of Participants
1241076|NCT00574171|Primary|Response Rate of Lapatinib/Capecitabine.||duration of study; on average 1 year||||participants|||Number
1241590|NCT00569803|Secondary|Number of Participants With Physical Examination Abnormalities|All clinically significant deviations from normal physical examinations were reported.|Days 1, 2, 5, 14, 28, 42, 86, 116|All treated participants|||participants|||Number
1241077|NCT00574145|Secondary|Intensity of Anxiety and Depression|Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints.|baseline and off-radiation at 5 to 7 weeks|Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks|||units on a scale||Full Range|Median
1241078|NCT00574145|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)|36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined|baseline and 6 weeks|Arm A:1 patient was accidentally notified of group assignment before final data collected, 2 patients withdrew (1 at 2 days), 1 at 5 days. )Arm B: 1 patient withdrew at 4 weeks|||units on a scale||Full Range|Median
1241079|NCT00574145|Primary|Fatigue Using the Brief Fatigue Inventory (BFI)|9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.|6 weeks|Patients who completed 5 of 8 maximum collection points. Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks|||units on a scale||Standard Deviation|Mean
1241080|NCT00574080|Primary|Event Free Survival|Time from study registration until disease progression or death.|Up to 3 years 8 months|no analysis, participants either died or were withdrawn by PI. study terminated with <10% of target accrual enrolled.||||||
1241081|NCT00574067|Secondary|HIV Risk Behavior|Number of times had sex without using a condom during the past year|1 year||||times||Standard Deviation|Mean
1241082|NCT00574067|Secondary|HIV Risk Behavior Needle Sharing|Number of times shared a needle during the past year|1 year||||times||Standard Deviation|Mean
1241083|NCT00574067|Secondary|Employment Status|Number of days employed during the past year|1 year||||days||Standard Deviation|Mean
1241084|NCT00574067|Secondary|Criminal Activity|Days of crime during the past 30 days|1 year||||days||Standard Deviation|Mean
1241085|NCT00574067|Secondary|Number of Days of Cocaine Use|Number of days used cocaine during the past 30 days.|1 year||||days||Standard Deviation|Mean
1241086|NCT00574067|Primary|Drug Abuse Treatment Entry and Retention in the Community|entered community treatment within 10 days of release from prison (yes vs. no)|1 year||||participants|||Number
1241087|NCT00574067|Primary|Number of Days of Heroin Use|mean days used heroin during the past 30 days|1 year||||days||Standard Deviation|Mean
1241088|NCT00573989|Secondary|Objective Tumor Response|Objective Tumor Response reported on participants at 1 year (complete, partial, progression, or stable response).|1 year|Data corresponds to Phase II patients.|||Participants|||Count of Participants
1241089|NCT00573989|Secondary|Evaluation of Biomarkers||throughout study completion, up to 2 years|Patients refused biopsy, so no data collected.||||||
1241090|NCT00573989|Secondary|Change in Quality of Life: MDADI|The M.D. Anderson Dysphagia Inventory (MDADI) was used to assess effects of dysphagia on the quality of life of patients with head and neck cancer. It incorporates 3 domains (emotional, functional, and physical) as well as 1 global question. Each subscale with five possible responses scored on a scale of 1 to 5 (strongly agree, agree, no opinion, disagree and strongly disagree). Scores range from 0 (extremely low functioning) to 100 (higher functioning). Higher MDADI score represents better day-to-day functioning and better quality of life.|baseline and 12 months|Data not collected on all participants at 12 months. Data corresponds to Phase II patients.|||units on a scale||Standard Deviation|Mean
1241091|NCT00573989|Secondary|Change in Quality of Life: PSS-HN|The Performance Status Scale for Head & Neck Cancer Patients (PSS-HN) is s designed to evaluate performance in areas of functioning most likely affected by head and neck cancer and its treatment, specifically Normalcy of Diet, Eating in Public, and Understandability of Speech. Each subscale is rated from 0 to 100, with higher scores indicating better performance|baseline and 6 months|Data not collected for all participants.|||units on a scale||Standard Deviation|Mean
1241092|NCT00573989|Secondary|Change in Quality of Life- FACT H&N|The Functional Assessment of Cancer Therapy-Head and Neck (FACT H&N) consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain. Score range is 0-156. Higher scores denotes better outcomes|baseline and 12 months|Data not collected for all participants at 12 months. Data corresponds to Phase II patients.|||units on a scale||Standard Deviation|Mean
1241093|NCT00573989|Secondary|Evaluation of Acute and Chronic Toxicity|Evaluate acute and chronic toxicity of the combined re-irradiation with radiosensitizing drugs: Pemetrexed and Erlotinib. Adverse events with Common Toxicity Criteria grades of 4 and 5 are reported for phase I and II.|1 year|Data corresponds to Phase II patients.|||events|||Number
1241094|NCT00573989|Secondary|Overall Survival|Overall survival of participants reported after 2 years.|1 and 2 years|Data corresponds to Phase II patients.|||Participants|||Count of Participants
1241095|NCT00573989|Secondary|Median Overall Survival|Median Overall Survival of participants reported after 2 years.|up to 5 years|Data corresponds to Phase II patients.|||years||95% Confidence Interval|Median
1241096|NCT00573989|Secondary|Median Progression Free Survival|Median Progression Free Survival of participants reported after 2 years.|2 years|Data corresponds to Phase II patients.|||years||95% Confidence Interval|Median
1241097|NCT00573989|Primary|Progression-free Survival (PFS) at 1 Year (Phase II)|Determine Progression Free Survival at 1 year defined as the percentage of patients who are alive at 1 year after beginning of their concurrent re-irradiation and chemotherapy without loco-regional progression of their disease as measured by CT scan or MRI.|1 year|Data corresponds to Phase II patients.|||Participants|||Count of Participants
1241098|NCT00573989|Primary|Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)|Dose at which 100% of participants tolerated the dose|56 Days||||mg|||Number
1241103|NCT00573872|Primary|Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy|"Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as worse, stable, better, or completely resolved. In the reporting better or completely resolved indicates response to treatment."|2 years||||Participants|||Count of Participants
1241104|NCT00573859|Secondary|The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.|The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal.|4 days||||scores on a scale||Full Range|Median
1241105|NCT00573859|Secondary|The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.|In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT.|4 days||||errors||Standard Error|Mean
1241106|NCT00573859|Primary|The Effects of ADHD Medication Versus Placebo on Cotinine Levels|Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.|4 days|Smokers with ADHD|||ng/ml||Standard Error|Mean
1241107|NCT00573833|Other Pre-specified|Median International Prostate Symptom Total Score|Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach’s alpha = 0.84) with excellent test-retest reliability (r = 0.92).|week 12 reported||||scores on a scale||Full Range|Median
1241108|NCT00573833|Other Pre-specified|Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)|week 12 reported||||participants|||Number
1241109|NCT00573833|Primary|Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity|urinary and rectal toxicity-see the adverse event tables|Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)||||participants|||Number
1241110|NCT00573833|Primary|Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity|Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as > or = grade 3 NCI CTC toxicity|At scheduled 3 month intervals for one year||||participants|||Number
1241111|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||mg/L||Standard Deviation|Mean
1241112|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||g/L||Standard Deviation|Mean
1241113|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||mmol/L||Standard Deviation|Mean
1241114|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in ITT-1 population with both Baseline and visit values.|||μmol/L||Standard Deviation|Mean
1241115|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||U/L||Standard Deviation|Mean
1241116|NCT00573794|Secondary|Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||cells * 10^9/L||Standard Deviation|Mean
1241117|NCT00573794|Secondary|Hematology: Mean Change From Baseline to Final Values in Hematocrit|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||Percentage of red blood cells||Standard Deviation|Mean
1241118|NCT00573794|Secondary|Hematology: Mean Change From Baseline to Final Values in Hemoglobin|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||g/L||Standard Deviation|Mean
1241119|NCT00573794|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks)|Safety analysis set: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1241120|NCT00573794|Secondary|Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to ulcerative colitis since the last visit. The cumulative number of unscheduled utilizations over the course of the study is presented.|5 years|ITT-1 population|||cumulative number of utilizations|||Number
1241121|NCT00573794|Secondary|Colectomy Rate|The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.|5 years|ITT-1 population|||percentage of participants|||Number
1241122|NCT00573794|Secondary|WPAI:GH Activity Impairment: Change From Baseline Over Time|The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||percent activity impaired||Standard Deviation|Mean
1241123|NCT00573794|Secondary|WPAI:GH Overall Work Impairment: Change From Baseline Over Time|The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||percent of overall work impairment||Standard Deviation|Mean
1241124|NCT00573794|Secondary|WPAI:GH Impairment While Working: Change From Baseline Over Time|The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||percent of work time impaired||Standard Deviation|Mean
1241125|NCT00573794|Secondary|Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time|The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||percent of work time missed||Standard Deviation|Mean
1241126|NCT00573794|Secondary|36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241127|NCT00573794|Secondary|36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241128|NCT00573794|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time|The IBDQ is a 32-item questionnaire that assesses how the subject felt during the 2 weeks before the measurement time point. Questions are related to symptoms the subject might have had as a result of UC, how the subject felt in general, how the subject's mood was, and social and work problems the subject might have that resulted from UC. An increase in IBDQ score indicates less impact of UC on the subject's life. The responses to each question range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241129|NCT00573794|Secondary|Mayo Stool Frequency Subscore: Change From Baseline Over Time|The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241130|NCT00573794|Secondary|Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time|The Mayo Physician's Global Assessment of Disease Severity subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Physician's Global Assessment of Disease Severity subscore indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241131|NCT00573794|Secondary|Mayo Rectal Bleeding Subscore: Change From Baseline Over Time|The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241132|NCT00573794|Secondary|Mayo Endoscopy Subscore: Change From Baseline Over Time|The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241133|NCT00573794|Secondary|Percentage of Participants With Remission Per Partial Mayo Score Over Time|The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). Remission was defined as Partial Mayo score ≤ 2 with no subscore > 1.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with evaluable data at given timepoint.|||percentage of participants|||Number
1241134|NCT00573794|Primary|Mayo Score: Change From Baseline Over Time|The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241135|NCT00573794|Primary|Partial Mayo Score: Change From Baseline Over Time|The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
1241136|NCT00573768|Primary|Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.|Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)|change from baseline (on day 1) to day 5|Intent to treat (ITT)|||mm||Standard Deviation|Mean
1241137|NCT00573755|Secondary|Adverse Event|Number of participants that experienced adverse events (grade 3 and above) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Adverse events were assessed every week during first 6 weeks of therapy, every 4 weeks on months 1 to 6, every 12 weeks on months 7 and beyond and at the end of treatment.|Time from randomization to end of treatment||||participants|||Number
1241138|NCT00573755|Secondary|Duration of Response|Duration of response was defined for all patients who have achieved a confirmed response as the date at which the patient's earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.|Up to 5 years|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.||||||
1241139|NCT00573755|Secondary|Objective Tumor Response Rate|A confirm response was defined as either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluation at least 4 weeks apart. The confirmed response rate was estimated within each treatment group by the number of confirmed responses divided by the total number of participants randomized.|Up to 5 years|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.||||||
1241140|NCT00573755|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the date of the randomization to the date at which the patient was removed from treatment due to progression, adverse events, or refusal.|Time from randomization to treatment failure (up to 5 years)|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.||||||
1241141|NCT00573755|Secondary|Overall Survival|Survival time was defined as the time from randomization to death due to any cause.|Time from randomization to death (up to 5 years)|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome. All patients were alive at the time of their last treatment follow up.||||||
1241183|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).|baseline and at end of a 4-week intervention||||Ratio||Standard Deviation|Mean
1241142|NCT00573755|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment and then never return for any evaluations, the participant was censored for progression 1 day post-randomization.|Time from randomization to disease progression or death (up to 5 years)|All participants who have met the eligibility criteria, signed a consent form and were randomized to one of the two treatment groups were evaluable for the primary endpoint.|||months||95% Confidence Interval|Median
1241143|NCT00573534|Secondary|Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology.|This outcome measure integrates data from self report supplied in the Time Line Follow Back (a self report summary of all substance and alcohol use over the previous week or month) with evidence from periodic (weekly to monthly) urine toxicologies.|up to 24 weeks|The 8 subjects who took at least one dose of the medication and returned for follow up were included.|||participants|||Number
1241144|NCT00573534|Primary|Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit|The outcome is the number of subjects who achieved a clinically meaningful reduction in ADHD symptoms. This is defined as a 70% reduction from baseline as measured by change in the ADHD Rating Scale (ADHD-RS). The ADHD RS quantifies symptoms on a 0-3 scale, 0 meaning never present, 1 sometimes, 2 often present, 3 very often present. For this study, the scale was clinician administered using both parent and adolescent to achieve a consensus score, or a best estimate on the clinician's part when consensus could not be achieved|up to 24 weeks|All patients who agreed to participate. Last Observation Carried Forward was used final outcome.|||participants|||Number
1241145|NCT00573508|Secondary|Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary|"The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids.~Change from baseline with a lower score indicates an improvement.~End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table.~Change is calculated as EOT - Baseline"|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The number of participants for each timepoint / parameter are noted in the category titles."|||Number of Category Events / 24 Hours||Standard Deviation|Mean
1241146|NCT00573508|Secondary|Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)|"The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely).~Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study.~Change is calculated as EOT - Baseline"|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each row are noted in the category titles."|||TS-VAS||Standard Deviation|Mean
1241147|NCT00573508|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.|"ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized female patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||ICIQ-FLUTSsex||Standard Deviation|Mean
1241148|NCT00573508|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.|"ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized male patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||ICIQ-MLUTSsex||Standard Deviation|Mean
1241149|NCT00573508|Secondary|Change From Baseline in the MCUI Behavior Therapy Stratified|"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.|||Number of Days||Standard Deviation|Mean
1241150|NCT00573508|Secondary|Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months|"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.|||Number of categorical items||Standard Deviation|Mean
1241151|NCT00573508|Secondary|Change From Baseline in Work Productivity Assessment Index (WPAI)|"The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting.~A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study.~Change from baseline is based on the ANCOVA model after adjusting baseline value & center."|Baseline and 12 Weeks|"Population is full analysis set (FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint / parameter are noted in the category titles."|||Percentage of indicated parameter||Standard Deviation|Mean
1241152|NCT00573508|Secondary|Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100.~Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.~Change is calculated End of Treatment (EOT) for each sub-domain – Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~Number of participants analyzed per arm represents FAS. The numbers of participants for each visit/sub domain are noted in the category titles."|||OAB-q HRQL Sub Domain Score||Standard Deviation|Mean
1241153|NCT00573508|Secondary|Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire|The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy.|Baseline and 12 Weeks|"The number assessed included all participants who completed the BSW questionnaire at baseline visit (visit 2) and end of treatment (visit 5/early withdrawal).~A few patients who completed the BSW Questionnaire did not adequately complete the  Benefits Section and therefore are considered 'N/A' for that Section."|||Participants|||Number
1241154|NCT00573508|Secondary|Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)|"The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems~Improvement is defined by any reduction in PPBC score.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.|||Participants|||Number
1241155|NCT00573508|Secondary|Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.~Change is calculated as Actual Data for each time point - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||OAB-q HRQL Total Score||Standard Deviation|Mean
1241156|NCT00573508|Secondary|Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~Change is calculated as Actual Data for each timepoint - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||OAB-q Score||Standard Deviation|Mean
1241184|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).|baseline and at end of a 4-week intervention||||Intervals more than 50 ms||Standard Deviation|Mean
1241157|NCT00573508|Primary|Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment - Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants per arm is consistent for all categories / rows of the data table."|||OAB-q Score||Standard Deviation|Mean
1241158|NCT00573469|Secondary|Change in CDAI Score From Baseline to 8 Weeks|CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured.|Baseline to 8 weeks||||Score on a scale||Standard Deviation|Mean
1241159|NCT00573469|Secondary|Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method|Time from randomisation to the remission of Crohn's disease defined as CDAI score  150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained.|At 8 weeks||||Percentage of participants|||Number
1241160|NCT00573469|Secondary|Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment|The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.|Baseline to 4 weeks||||Participants|||Number
1241161|NCT00573469|Secondary|Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment|The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.|Baseline to 2 weeks||||Participants|||Number
1241162|NCT00573469|Primary|Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment|Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.|Baseline to 8 weeks||||Participants|||Number
1241163|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Pain Rating Scale (PRS) of MS Subjects|Subjects with MS were instructed to also record daily the pain they experienced using the PRS. After evaluating the subject's ability to comply with these requirements, the investigator determined if a caregiver should complete the study diary and assessments. Subjects rated their pain over the past 12 hours on a scale of 0 to 10 (0=none, 10=worst pain ever experienced).|Baseline, Day 15, Day 29, Day 57, Day 84|ITT Population - MS Subjects only|||Scores on a Scale||Standard Deviation|Mean
1241164|NCT00573443|Secondary|Mean Change From Baseline at Day 84 in Beck Depression Inventory (BDI-II) Total Score|The BDI-II is a 21-item self report instrument intended to assess the existence and severity of symptoms of depression, summed to give a single score. The BDI-II uses a 4-point for each item ranging from 0 to 3. A total score of 0-13 is considered minimal range, 14 to 19 is mild, 20 to 28 is moderate, and 29 to 63 is severe.|Baseline and Day 84|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1241165|NCT00573443|Secondary|Mean Change From Baseline at Day 84 in SF-36 (Short-Form) Health Survey Medical Outcome Score by Category|The SF-36 is designed to examine a person’s perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 – 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.|Baseline and Day 84|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1241166|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (ITT Population)|The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).|Baseline to Day 84|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1241167|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (EE Population)|The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).|Baseline to Day 84|Efficacy Evaluable (EE) Population - included all subjects who were protocol adherent, defined as those who completed the Day 84 visit or the end-of-study visit within 48 hours of a discontinuation, and who took as least 80% of their scheduled doses prior to discontinuation of the study medication.|||Scores on a Scale||Standard Deviation|Mean
1241206|NCT00573170|Secondary|Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain|Pain relief is defined as having no or mild pain and no use of rescue medication after dosing in those participants who had moderate or severe pain at dosing.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - only participants who reported moderate or severe baseline pain were included in this analysis.|||participants|||Number
1241168|NCT00573443|Secondary|Mean Change From Baseline in CNS-LS Total Score by Visit|Center for Neurologic Studies-Lability Scale (CNS-LS) is an instrument for the measurement of PBA that has been validated for the use in patients with ALS and MS. It is a 7-item self-report questionnaire that measures the frequency and severity of PBA episodes, including assessments of labile laughter and labile tearfulness,and provides a score for total PBA (total score can range from 7-35). The following 5-point scoring was used: 1=Applies never, 2=Applies rarely, 3=Applies occasionally, 4=Applies frequently, 5=Applies most of the time. A score of 13 or higher may suggest PBA, and the higher the score the more severe the episodes.|Baseline, Day 15, Day 29, Day 57, Day 84|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1241169|NCT00573443|Primary|PBA Episode Rate Ratio (Post/Pre), Regression Adjusted|Episodes were counted each day and recorded in a daily diary. The outcome measure is the ratio of the episode rate over the 84-day treatment period to the rate during the baseline period, adjusted for study site, and underlying disease using longitudinal negative binomial regression.|Baseline to Day 84|Intent-to-Treat (ITT) population - included all randomized subjects for the double-blind phase and all enrolled subjects for the open-label extension phase.|||Unit-free (ratio of episodes/week)||95% Confidence Interval|Least Squares Mean
1241170|NCT00573430|Secondary|Treatment-emergent Adverse Events|Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.|Baseline to 28 weeks||||Participants|||Number
1241171|NCT00573430|Secondary|Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation|GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)|28 weeks||||mL/min/1.73 m2||Standard Deviation|Mean
1241172|NCT00573430|Secondary|Inflammatory Marker (Hs-C-peptide Reactive Protein)|To evaluate how to reduce and relate with cardiovascular risk|baseline to 28 weeks||||mg/dL||Standard Deviation|Mean
1241173|NCT00573430|Secondary|Change of Systolic and Diastolic Blood Pressure From Baseline||baseline to 28 weeks||||mmHg||Standard Deviation|Mean
1241174|NCT00573430|Primary|The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks|Decrease of urinary protein/creatinine ratio means improvement of renal disease.|baseline to 28 weeks||||mg/g||Standard Deviation|Mean
1241175|NCT00573391|Primary|Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment|due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone|24 months||||Participant|||Number
1241176|NCT00573313|Secondary|Changes in Serum SAM|We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline.|September 2005- June 2009|Whereas 37 subjects started the protocol, due to protocol violation, there remained 26 subjects, 13 in each group, for final analyses. Here are reported changes in AST values to represent all variables.|||nmol/liter||Full Range|Median
1241177|NCT00573313|Primary|Changes in Serum AST Levels|Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.|Week 0 to week 24|Analysis of AST values was based on numbers of participants in each group who completed the study. Analysis is pre-specified to apply only to subjects with alcoholic liver disease.|||Units per liter (U/L)||Full Range|Median
1241178|NCT00573287|Secondary|Improvement in Psychiatric Symptoms Measured Using the BPRS, CGIS, and SANS at 24 Week|Given small number of completers, we modified the data analysis to focus on detecting pattern change. Three blinded raters judged whether the participant demonstrated improvement, worsening or no change (no change as less than 20% change) over the course of study participation for the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impressions Scale (CGIS) and Schedule for the Assessment of Negative Symptoms (SANS) at 24.|24 weeks|Improved in the named measure as deemed by blinded raters|||participants|||Number
1241179|NCT00573287|Primary|Number of Participants Demonstrating Improvement in Substance Use|"Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on cannabis use was gathered weekly using the Timeline Follow-back (TLFB) method. At the end of the study, graphs were plotted showing days of cannabis use per week and rated as “Improved,” “Unchanged,” or “Worse” by a pair of expert judges. Raters were instructed to rate the graph “Improved” or “Worsened” if it appeared to be >20% better or worse and to rate it Unchanged if there was little or no change (less than ~20%)."|24 weeks|Analysis was conducted for participants who were randomized to study medication condition and actually began treatment with study drug and had a follow-up visit. Two patients (one in the Clozapine group and one in the Risperidone group) did not meet this criteria and were not included in the analysis.|||participants|||Number
1241180|NCT00573261|Secondary|To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.|The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired).|baseline and at end of a 4-week intervention||||units on a scale||Standard Deviation|Mean
1241181|NCT00573261|Secondary|To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms)|baseline and at end of a 4-week intervention||||units on a scale||Standard Deviation|Mean
1241182|NCT00573261|Secondary|To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety).|baseline and at end of a 4-week intervention||||units on a scale||Standard Deviation|Mean
1241185|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN).|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||milliseconds||Standard Deviation|Mean
1241186|NCT00573261|Primary|Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/[total power-VLF]) and normalized HF (normalized HF=HF/[total power-VLF]).|baseline and at end of a 4-week intervention||||Ratio||Standard Deviation|Mean
1241187|NCT00573261|Primary|Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz).|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||Hertz (Hz)||Standard Deviation|Mean
1241188|NCT00573261|Primary|Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram.|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||Beats Per Minute||Standard Deviation|Mean
1241189|NCT00573261|Secondary|To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain.|baseline and end of 4 week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and their 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||units on a scale||Standard Deviation|Mean
1241190|NCT00573261|Primary|Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.||baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||mm Hg||Standard Deviation|Mean
1241191|NCT00573248|Primary|Side Effects|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days||||Percent of item endorsement||Standard Error|Mean
1241192|NCT00573248|Primary|Negative Moods|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days||||Percent of item endorsement||Standard Error|Mean
1241193|NCT00573248|Secondary|Blood Pressure|Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches|4 days||||mm HG||Standard Deviation|Mean
1241194|NCT00573248|Primary|ADHD Symptoms|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days|Per protocol, average ADHD symptoms, cardiovascular activity and moods during nicotine compared to placebo.|||Percent of item endorsement||Standard Error|Mean
1241195|NCT00573183|Secondary|Attendance at 12-step Meetings|Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period|6 months|The sample size was originally powered based on the primary outcome measure, not on the secondary 12-step measures.The analysis sample size was reduced due to missing values|||days of attending 12-step meetings||Standard Deviation|Mean
1241196|NCT00573183|Primary|Days of Stimulant Use|Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period|6 months|The original sample size was based on power analysis and took attrition into account. Of the 471 individuals randomized to treatment, 50 subjects (TAU, n=20, STAGE-12, n=30) did not have any post-baseline measures and were therefore eliminated from the statistical analysis of the primary outcome and some of the secondary outcomes.|||days of stimulant use||Standard Deviation|Mean
1241197|NCT00573170|Secondary|"Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire)"|"Clinical disability for each participant was assessed using the CDQ. This scale uses one question to assess ability to perform normal or usual activities. Responses are recorded on a 5-point scale, where 1 is normal/not impaired, 2 is mildly impaired, 3 is moderately impaired, 4 is severely impaired, and 5 is 'required bedrest."|At dosing and at 2, 4, 6 and 8 hours after dosing of each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
1241198|NCT00573170|Secondary|Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
1241199|NCT00573170|Secondary|Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
1241200|NCT00573170|Secondary|Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
1241201|NCT00573170|Secondary|Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
1241202|NCT00573170|Secondary|Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
1241203|NCT00573170|Secondary|Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing|"Participant alertness was evaluated with the 7-point modified SS scale, where 1 is feeling active, vital, alert, wide awake, 2 is still functioning at high levels, but not peak; able to concentrate, 3 is awake, but relaxed; responsive but not fully alert, 4 is somewhat foggy, let down, 5 is foggy, losing interest in remaining awake, 6 is sleepy, woozy, fighting sleep, prefer to lie down, and 7 is no longer fighting sleep, sleep onset soon, having dream like thoughts."|Dose time, 2, 4, 6, 8, 24 and 48 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population. Only participants who responded to the SS scale at a particular time point were included in the analysis for that time point.|||units on a scale||Standard Deviation|Mean
1241204|NCT00573170|Secondary|Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing|Overall cognition was assessed with a composite score (range 0-9) called the Performance Index, as derived from the number of correct responses per minute on subtests of the Mental Efficiency Workload Test (MEWT) cognitive battery. For a particular participant, lower scores indicate a negative impact, or worsened, general cognition; higher scores indicate improved cognition.|At time of dosing, and at 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||scores on a scale||Standard Deviation|Mean
1241205|NCT00573170|Secondary|Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing|Complete symptom-free is defined as migraine-free, neck pain-free, and sinus pain-free without the use of any rescue medication prior to the defined time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
1241207|NCT00573170|Secondary|Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline|The number of participants with no pain and relief of neck pain in those participants for whom neck pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported neck pain at dose time.|||participants|||Number
1241208|NCT00573170|Secondary|Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing|The number of participants with no pain and relief of sinus/facial pain in those participants for whom sinus/facial pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported sinus/facial pain at dose time.|||participants|||Number
1241209|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose|The number of participants with no pain and relief of vomiting in those participants for whom vomiting was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported vomiting at dose time.|||participants|||Number
1241210|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of phonophobia in those participants for whom phonophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported phonophobia at dose time.|||participants|||Number
1241211|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of photophobia in those participants for whom photophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported photophobia at dose time.|||participants|||Number
1241212|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of nausea in those participants for whom nausea was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported nausea at dose time.|||participants|||Number
1241213|NCT00573170|Secondary|Number of Participants With a Migraine-free Response 2-48 Hours After Dosing|Migraine-free is defined as pain-free with no migraine-associated symptoms (nausea, vomiting, photophobia [sensitivity to light], and phonophobia [sensitivity to sound]) with use of any rescue medication before the defined time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
1241214|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their third migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 3 with study medication and then used migraine rescue medication after dosing.|||hours||Standard Deviation|Mean
1241215|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their second migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 2 with study medication and then used migraine rescue medication after dosing.|||hours||Standard Deviation|Mean
1241216|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for the first migraine attack treated. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 1 with study medication and then used migraine rescue medication after dosing.|||hours||Standard Deviation|Mean
1241217|NCT00573170|Secondary|Number of Participants Using Rescue Medication Within 48 Hours Post Dose|Number of participants who took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
1241218|NCT00573170|Secondary|Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose|Pain-Free is defined as having no pain and without the use of any rescue medication from the time of the initial dose of study medication for a particular migraine attack until the defined time point at 2, 4, 6, 8, 24 or 48 hours post-dose.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
1241219|NCT00573170|Primary|Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose|SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.|From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Intent-to-Treat (ITT) Population: all participants who were treated with investigational product and provided at least one post-dose efficacy assessment . Participants may have been included in one, two, or all of the Placebo, Treximet and Butalbital-containing combination medication arms due to the cross-over nature of the study design.|||participants|||Number
1241220|NCT00573157|Secondary|Number of Participants With New Lupus Flares||At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.||||||
1241221|NCT00573157|Secondary|Percentage of Participants With Normalization of Renal Function||At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.||||||
1241222|NCT00573157|Primary|Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response|Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate [GFR]), improvement in proteinuria (urine protein/creatinine ratio <0.5) & resolution of hematuria. Partial response (PR): from baseline, a <= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) & resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.|At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.||||||
1241223|NCT00573144|Secondary|Myocardial Infarct Size at 30 Days|Myocardial infarction or acute myocardial infarction (AMI) is the medical term for an event commonly known as a heart attack. Myocardial (heart muscle) infarction is tissue death (also known as necrosis) caused by a local lack of oxygen, due to an obstruction of the tissue's blood supply. The resulting heart tissue lesion is referred to as an infarct. A larger size or area of infarct indicates a greater amount of heart tissue death. Myocardial infarct size was measured using a cardiac Magnetic Resonance Imaging (MRI) scan at 30 days and is the mass of the infarcted tissue divided by the mass of the left ventricle times 100%.|30 days||||percentage of total cardiac tissue mass||Standard Deviation|Mean
1241224|NCT00573144|Secondary|Change in Left Ventricular End-Systolic Diastolic Volume Index|Change in Left Ventricular end-systolic diastolic volume index determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart’s major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.|baseline, 30 days||||mL blood/meter^2 body surface area||Standard Deviation|Mean
1241225|NCT00573144|Primary|Change in Left Ventricular End-Systolic Volume Index|Change in Left Ventricular end-systolic volume index as determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart’s major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.|baseline, 30 days||||mL of blood/meter^2 body surface area||Standard Deviation|Mean
1241227|NCT00573066|Primary|PK Profile of Dexmedetomidine|This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.|after start of infusion (0.5, 1, 2, 4-6 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2, 4, 8, 12, 15-18 hours)|Based on an estimated inter-subject variability of 50% for steady state concentration, a sample size of 36 evaluable subjects will be sufficient to detect a difference (alpha 0.05, power 0.8) for the area under the concentration-time curve (AUC) and steady state concentration (Css) between the three dosing groups.|||mL/min/(kg^0.75)||Standard Error|Least Squares Mean
1241228|NCT00572936|Primary|Uvescleral Outflow|uvescleral outflow was calulated using goldmann equation|2 weeks||||µL/min per mm Hg||Standard Deviation|Mean
1241229|NCT00572936|Primary|Outflow Facility|outflow facility was calculated using fluorophotometry and tonography|2 weeks||||µL/min per mm Hg||Standard Deviation|Mean
1241230|NCT00572936|Primary|Episcleral Venous Pressure|Episcleral venous pressure was measured by venomenometry|2 weeks||||mmHg||Standard Deviation|Mean
1241231|NCT00572936|Primary|Blood Pressure|blood pressure was measured by sphygmomanometry|2 weeks||||mmHg||Standard Deviation|Mean
1241232|NCT00572936|Primary|Anterior Chamber Volume|Anterior chamber volume was measured by A-scan ultrasound biometry, daytime|2 weeks||||μL||Standard Deviation|Mean
1241233|NCT00572936|Primary|Central Corneal Thickness|central corneal thickness was measured by ultrasound pachymetry|2 weeks||||μm||Standard Deviation|Mean
1241234|NCT00572936|Primary|Aqueous Flow|aqueous flow measurements was calculated using fluorophotometry measurements.|2 weeks||||μL/min||Standard Deviation|Mean
1241235|NCT00572936|Primary|Intraocular Pressure|Intra-ocular Pressure was measured by applanation tonometry|2 weeks||||mmHg||Standard Deviation|Mean
1241236|NCT00572910|Primary|Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)|"Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3.~Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination."|Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.||||Participants|||Number
1241237|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints|Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.|Prevaccination to 360 days post vaccination||||Ratio||95% Confidence Interval|Geometric Mean
1241238|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination|Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.|Prevaccination to 56 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1241239|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.|Prevaccination to 180 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1241240|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.|Prevaccination to 28 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1241241|NCT00572910|Primary|Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.|Prevaccination to 56 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1241242|NCT00572897|Secondary|Transplant-related Mortality|Transplant-related Mortality including Graft-versus-host disease (GVHD)|2 years||||participants|||Number
1241243|NCT00572897|Secondary|PLT|Patients with PLT ≥20 × 109/L|2 years||||participants|||Number
1241244|NCT00572897|Secondary|Absolute Neutrophil Count (ANC)|Patients with ANC ≥0.5 × 10^9/L|2 years||||participants|||Number
1241245|NCT00572897|Secondary|Overall Survival|The number of patients alive at last follow-up.|73 months||||participants|||Number
1241246|NCT00572897|Secondary|Response Outcomes|assessed according to the IWG Criteria|180 days|Clinical responses were assessed according to the IWG-MRT 2006 criteria in 46 patients (29 sibling and 17 unrelated transplants) who survived at least 180 days.|||participants|||Number
1241247|NCT00572897|Primary|The Primary Endpoint is Progression-free Survival.|Number of participants alive at 2 years who are progression-free|2 years||||participants|||Number
1241248|NCT00572832|Primary|Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule|Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.|1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)|The analysis was by intention to treat. Participants who had positive baseline antibody titers were excluded from further analyses only for the type(s) for which they were seropositive.|||milliMerck units per mL||95% Confidence Interval|Geometric Mean
1241249|NCT00572728|Secondary|%Change SUVmax From FLT1‐FLT3 to Predict Lymph Node Status at Surgery|%change in SUVmax from FLT1‐FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1‐FLT3 will be consider the outcome.|Baseline (FLT-1) and post-NAC (FLT-3)|Data on 30 patients with FLT3 were available for histopathological LN evaluation after NAC: 11 with negative nodes, 13 with 1‐3 LN metastases and 6 with >3 LN metastases|||percent change in SUVmax from FLT1‐FLT3||Standard Deviation|Mean
1241250|NCT00572728|Secondary|%Change SUVmax From FLT1‐FLT2 to Predict Lymph Node Status at Surgery|Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome.|Baseline (FLT-1) and Early Therapy (FLT-2)|Data on 38 patients having FLT1 and FLT2 were available for histopathological LN evaluation after NAC: 14 with negative nodes, 15 with 1‐3 LN metastases and 9 with >3 LN metastases|||percent change in SUVmax from FLT1‐FLT2||Standard Deviation|Mean
1241251|NCT00572728|Secondary|Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor|"To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome.~Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section"|Baseline (FLT-1) and post-NAC (FLT-3)|43 patients who had both FLT1 and FLT3 scans|||percentage change in SUVmax||Standard Deviation|Mean
1241252|NCT00572728|Secondary|SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein.|post-NAC (FLT-3)|After completion of NAC (FLT-3): only 31 patients had both FLT3 and RCB evaluation: 11 patients with RCB 0/I and 20 patients with RCB II/III|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
1241253|NCT00572728|Secondary|SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|"While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein.~Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III"|early treatment (FLT2)|after one cycle of NAC (FLT2): 35 patients had FLT-2 and RCB evaluation: 14 patients with RCB 0/I and 21 patients with RCB II/III|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
1241254|NCT00572728|Secondary|SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|"While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein.~Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III"|Baseline (FLT-1)|@ Baseline: 35 patients with FLT-1 were evaluable for RCB: 14 patients with RCB 0/I and 21 patients with RCB II/III|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
1241255|NCT00572728|Secondary|Correlation Between SUVmax and Ki‐67 LI at FLT3 (Post-NAC)|For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells.|Post-NAC (FLT3)|43 patients who had suitable post‐NAC tissue samples for correlation between surgical specimens and FLT3 SUVs|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
1241256|NCT00572728|Secondary|Correlation Between SUVmax and Ki‐67 LI at FLT1(Baseline PET)|"For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 .~Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells."|Baseline (FLT-1)|1 of the 73 participants did not have both FLT-1 and Ki-67 LI available data|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
1241257|NCT00572728|Primary|%Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response|The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies|Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)|Percent Change in Maximum Standardized FLT uptake between the baseline (pre-therapy, FTL-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2)|||percentage change of SUVmax||Standard Deviation|Mean
1241258|NCT00572624|Secondary|Mean Homeostasis Model Assessment of Insulin Resistance|The homeostasis model assessment of insulin resistance (HOMA) was used to calculate insulin resistance using the first AM, fasting glucose and insulin levels. Plasma insulin levels were measured by radioimmunoassay, and glucose levels were measured by automated hexokinase assay. A HOMA score of <3 represents normal insulin resistance, a score between 3 and 5 moderate insulin resistance, and a score of 5 or higher represents severe insulin resistance.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||units on a scale||Standard Deviation|Mean
1241259|NCT00572624|Secondary|Mean Total Serum Cholesterol and Triglycerides|Blood testing was conducted at scheduled times during the study. Serum cholesterol and triglycerides were measured by the enzymatic method (Roche Diagnostics).|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||mg/dl||Standard Deviation|Mean
1243767|NCT00554099|Secondary|Recurrent Diverticulitis, Percentage, ITT Population, Week 52|At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).|52 Weeks|ITT Population|||Percentage of Participants|||Number
1241260|NCT00572624|Secondary|Mean Body Mass Index|Participant weight and height was measured at scheduled physical examinations. Body mass index was calculated as participant body weight in kilograms divided by their height in meters squared.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||kg/m^2||Standard Deviation|Mean
1241261|NCT00572624|Secondary|Mean Arterial Pressure|Mean arterial pressure was measured at scheduled physical examinations.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||mm Hg||Standard Deviation|Mean
1241262|NCT00572624|Secondary|Mean Heart Rate|Heart rate was measured at scheduled physical examinations.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||beats per minute||Standard Deviation|Mean
1241263|NCT00572624|Secondary|Left Ventricular (LV) Mass|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic study were performed using second harmonic imaging. Left ventricular (LV) mass was measured using the area-length method. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||grams||Standard Deviation|Mean
1241264|NCT00572624|Secondary|Septal Ratio (E/E’)|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic studies were performed using second harmonic imaging. The early diastolic (E) velocity was measured, left ventricular relaxation (E’) was measured at the lateral mitral annulus, and the E/E’(septal) ratio was calculated. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms. The normal septal ratio from the lateral mitral annulus is <5, a ratio from 5 to 10 is indeterminate, and a ratio of >10 indicates elevated left atrial pressure.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||ratio||Standard Deviation|Mean
1241265|NCT00572624|Secondary|Left Ventricular (LV) Relaxation (E’)|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic studies were performed using second harmonic imaging. Left ventricular relaxation (E’) was measured at the lateral annulus. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||cm/second||Standard Deviation|Mean
1241266|NCT00572624|Primary|Total Myocardial Fatty Acid (FA) Oxidation|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial fatty acid utilization was measured using positron emission tomography (PET) after injecting 1-^11C-palmitate. Total fatty acid oxidation was calculated by multiplying the fatty acid oxidation rate by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||nmol/g/min||Standard Deviation|Mean
1241267|NCT00572624|Primary|Total Myocardial Fatty Acid (FA) Utilization|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial blood flow was measured using positron emission tomography (PET) following injection of ^30O-water. Myocardial fatty acid (FA) utilization was measured using PET after injection of 1-^11C-palmitate. The calculations that describe the relationship between the different measures of myocardial FA metabolism are: FA utilization/gram = blood flow/gram × FA uptake/gram × [average plasma free FA at the time of the 1-11C-palmitate injection]; FA utilization/gram = FA oxidation/gram + esterification/gram. Total fatty acid utilization was calculated by multiplying the fatty acid utilization rate by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||nmol/g/min||Standard Deviation|Mean
1241268|NCT00572624|Primary|Total Myocardial Oxygen Consumption (MVO2)|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial oxygen consumption (MVO2) was measured using positron emission tomography (PET) following injection of 1-^11C-acetate. Total MVO2 was calculated by multiplying the MVO2 measure by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||µmol/min||Standard Deviation|Mean
1241269|NCT00572572|Secondary|Preferred Treatment Cycle|Participants were asked which treatment cycles was preferable - aprepitant or placebo cycle.|2 months|There were 49 subjects during the Aprepitant treatment and the Placebo treatment for each cycle that had complete data for the analysis of the preferred treatment cycle.|||percentage of subjects with a preference|||Number
1241270|NCT00572572|Secondary|MD Anderson Symptom Inventory Score|The MD Anderson Symptom Inventory (MDASI) is a brief measure of the severity and impact of cancer-related symptoms. Thirteen core items measure the severity of symptoms and six additional items measure the impact of symptoms. All items are rated on a scale from 0 (not present or did not interfere) to 10 (maximal severity or interference). The mean value of the total nineteen items ranges from 0 to 10.|Days 1-8|There were 64 subjects during the Aprepitant treatment and 62 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the M.D. Anderson Symptom Inventory. The mean MDASI scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.|||units on a scale||Standard Deviation|Mean
1241271|NCT00572572|Secondary|Visual Analouge (VAS) 100mm Scale Score|The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. The mean VAS scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.|Days 1-8|There were 54 subjects during the Aprepitant treatment and 61 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the visual analouge scale for nausea and vomiting.|||mm||Standard Deviation|Mean
1241272|NCT00572572|Secondary|Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)|Proportion of patients with no emesis regardless of use of rescue medication during cycle days 6-8.|Participants were evaluated from cycle days 6-8.||||percentage of evaluable subjects|||Number
1241273|NCT00572572|Secondary|Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)|Proportion of patients with no emesis regardless of use of rescue medication during cycle days 1-5.|Participants were evaluated from cycle days 1-5.||||percentage of evaluable subjects|||Number
1241274|NCT00572572|Primary|Complete Response.|Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.|Participants were evaluated from start of treatment through day 8 of cycle 2.||||percentage of evaluable subjects|||Number
1241275|NCT00572533|Post-Hoc|RBC Units Transfused|Total number of RBC units transfused|12 months|Intent-To-Treat, Missing Data Excluded|||RBC Units|||Number
1241276|NCT00572533|Post-Hoc|Subjects Receiving Transfusion|Number of Subjects receiving Transfusion|12 months|Intent-To-Treat, Missing Data Excluded|||Participants|||Number
1241277|NCT00572533|Secondary|ESA Dose|Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)|12 months|Intent-to-Treat Analysis, Missing Data Excluded|||IU||Standard Deviation|Mean
1241278|NCT00572533|Secondary|Mean Hb|Mean Hemoglobin concentration over follow-up period|12 months|Intent-To-Treat Analysis, Missing Data Excluded|||g/dL||Standard Deviation|Mean
1241279|NCT00572533|Secondary|Percent Hb > 12 g/dL|Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.|12 months|Intent-To-Treat, Missed Data Excluded|||Percent|||Number
1241280|NCT00572533|Post-Hoc|Transfusion Events|Number of Transfusion Events|12 months|Intent-To-Treat, Missing Data Excluded|||Events|||Number
1241281|NCT00572533|Secondary|Percent Hb < 10 g/dL|Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.|12 months|Intent-To-Treat Analysis, Missing Data Excluded|||Percent|||Number
1241282|NCT00572533|Primary|Percent Hb 10-12 g/dL|Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.|12 months|Intent-To-Treat Analysis, Missing Data Excluded|||Percent|||Number
1241283|NCT00572468|Secondary|Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy.|Compare the effect of pre-operative simvastatin versus placebo on prostate cancer cell apoptosis and its mediators in men undergoing planned prostatectomy. Apoptosis was measured by calculating the percent of Ki67 cellular staining.|2 years|We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.|||Percentage of cells||95% Confidence Interval|Mean
1241284|NCT00572468|Primary|Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.|Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue using Androgen Receptor (AR) antibody. AR was measured in tissue obtained at the time of prostatectomy in both benign and malignant tissues.|5 years|We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.|||Percentage of cells||95% Confidence Interval|Mean
1241285|NCT00572260|Primary|Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision||30 days after surgery|The study closed due to the departure of the principal investigator and the data analysis was not performed.||||||
1241286|NCT00572156|Secondary|Summary of Adverse Events With Number of Occurrences|A Data Monitoring Committee (DMC) was established to monitor subject safety|Approximately up to 4 years.|Safety population: Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.|||Number of events|||Number
1241287|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||pmol/L||Standard Deviation|Mean
1241288|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||mg/L||Standard Deviation|Mean
1241289|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||ng/mL||Standard Deviation|Mean
1241290|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||ng/mL||Standard Deviation|Mean
1241291|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||ng/mL||Standard Deviation|Mean
1241292|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||ng/mL||Standard Deviation|Mean
1241293|NCT00572156|Secondary|Skeletal Maturation|"Assessed by bone age. Bone age was determined by the radiograph.~The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At baseline(day 1), year 1,2,3 and 4|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).|||SDS||Standard Deviation|Mean
1241294|NCT00572156|Secondary|Total Change From Baseline (Day 1) in BMI SDS|"BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).~The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At year 1,2,3,4 and end of study (visit 23) versus baseline (day 1)|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).|||SDS||Standard Deviation|Mean
1241295|NCT00572156|Secondary|Predicted Adult Height (PAH)|"Predicted Adult Height calculated by method, Roche-Wainer-Thissen (RWT) and mid-parental target height SDS.~The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At baseline (Day 1), year 1,2,3 and 4|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).|||SDS||Standard Deviation|Mean
1241296|NCT00572156|Secondary|Cumulative Change in Height Standard Deviation Score (SDS)|"Height was measured standing and without shoes, and recorded as the mean of three measurements (the subject being repositioned each time) by the same observer using a Harpenden or other wall-mounted stadiometer which was to be calibrated prior to measurement of each subject and a calibration log kept.~The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|First, second, third and fourth year|Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||SDS||Standard Deviation|Mean
1241297|NCT00572156|Secondary|Height Velocity||Second, third and fourth year|Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||cm/y||Standard Deviation|Mean
1241298|NCT00572156|Primary|Height Velocity||First year of treatment|"Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.~[n= 25,27,27,26]"|||cm/y||Standard Deviation|Mean
1241299|NCT00572117|Secondary|Effect of Treatment on Mood Symptoms|The 17-item Hamilton Depression Rating Scale (HAM-D) is a standard measure of symptoms of depression with a scoring range of 0-53 points. Higher HAM-D scores represent more depression, so a lowering of HAM-D scores is considered a good outcome, an increase in HAM-D scores considered a worsening of outcomes.|Baseline and 12 weeks||||units on a scale||95% Confidence Interval|Mean
1241300|NCT00572117|Primary|Amount of Alcohol Consumed|Average number of drinks/heavy drinking days/week as measured using the Timeline Follow Back (TLFB) scale. A heavy drinking day is defined as a 5 or more standard drinks in a single day for males, 4 or more standard drinks in a single day for females. Drinks are standardized across types of alcohol to estimate the amount of alcohol consumes. For example, a 12 oz. beer of 4-5% alcohol by volume is considered one drink.|Baseline and 12 weeks||||number of drinks per heavy drinking day||95% Confidence Interval|Mean
1241301|NCT00572039|Secondary|Vision-related Quality of Life|We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.|6 months|105 PST and 110 ST participants provided data at 6 months.|||units on a scale||Standard Deviation|Mean
1241302|NCT00572039|Primary|Targeted Vision Function|We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its “difficulty” (on a scale of 0 [not difficult] to 4 [impossible]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.|6 months|105 PST and 110 ST participants provided data at 6 months.|||units on a scale||Standard Deviation|Mean
1241303|NCT00572039|Secondary|Vision-related Quality of Life|We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.|3-Months|106 PST and 112 ST participants provided data at 3 months.|||units on a scale||Standard Deviation|Mean
1241304|NCT00572039|Primary|Targeted Vision Function (TVF)|We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its “difficulty” (on a scale of 0 [not difficult] to 4 [impossible]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.|3-Months|106 PST and 112 ST participants provided data at 3 months.|||units on a scale||Standard Error|Mean
1241305|NCT00571987|Secondary|Recurrence of Breast Cancer at Prior Site of Disease||Until study end (2 years)|During the 68-month median follow-up in patients not treated with XRT, there were 2 in-site tumor recurrences treated with AI, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy.|||participants|||Number
1241306|NCT00571987|Primary|Number of Patients Requiring 2nd Surgery for Close or Positive Margins|"A close surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a wide surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined close as less than 3 mm."|Margins assessed at Final Pathology, approximately 1 week post-RF surgery||||participants|||Number
1241307|NCT00571974|Primary|The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR).|The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size.|Day 90|The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall.|||participants|||Number
1241308|NCT00571974|Primary|Maximum Tolerated Dose|The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989.|Day 2|Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures (laser doses) of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. The highest radiant light dose attained that did not produce more than 2 DLTs was declared to be the maximum tolerated dose (MTD).|||J/cm2|||Number
1241309|NCT00571961|Primary|Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)|Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period.|15 days||||(ng/mL)*hr||Standard Deviation|Mean
1241310|NCT00571948|Primary|Parameters of Iron Status in Blood||at the end of the fourth, seventh, tenth month of life|||||||
1241311|NCT00571948|Secondary|Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences||dietary intake: from the beginning of the third month of life to the end of the tenth month; anthropometric measures: at the end of the fourth, seventh, tenth month|||||||
1241312|NCT00571948|Primary|Sum of Omega-3 Fatty Acid Pattern in Plasma|"fatty acids were measured in the whole plasma (in mg). They were transformed into percent (%) per total fatty acids.~Results are shown as percent (%) per total fatty acids before and after the intervention as median (percentile 25th;75th)."|at the end of the tenth month of life||||percent of total fatty acids||Inter-Quartile Range|Median
1241313|NCT00571922|Secondary|Craving||7 day|PI passed away, data is unavailable||||||
1241314|NCT00571922|Primary|Methamphetamine Abstinence||7 day|PI passed away, data is unavailable.||||||
1241315|NCT00571701|Secondary|Maintenance of Response Following Discontinuation of Celecoxib|Percent of patients who responded to celecoxib with increase in papilloma growth rate of no greater than 0.01 at end of second treatment period compared to growth rate at end of first treatment period.|End of first treatment period (month 12) to end of second treatment period (month 24)|All patients with complete response to celecoxib in first treatment period who completed the second treatment period where they received placebo. Because the number of responders was so small, no statistical analysis was performed.|||percent of patients|||Number
1241316|NCT00571701|Secondary|Correlation Between Mean Plasma Level of Celecoxib and Response.|Mean plasma levels of celecoxib over months 3-12 in first treatment period correlated with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|All patients who were randomized to receive celecoxib first and completed the first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||pg. celecoxib/ml. plasma||Full Range|Mean
1241317|NCT00571701|Secondary|Effect of HPV 6 Versus HPV 11 on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%|Percent of patients with HPV 6 versus patients with HPV 11 with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|Analysis conducted on all patients with HPV 6 or 11 infection who completed first treatment period. One patient with both HPV 6 and 11 and one patient with neither 6 or 11 were excluded. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percent of responders|||Number
1241318|NCT00571701|Secondary|Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.|Percent of juvenile versus adult onset patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|Analysis conducted on all patients who completed first treatment period. Juvenile onset is defined as <18 years of age at time of diagnosis. Age of disease onset for 2 patients was not available. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percentage of responders|||Number
1241319|NCT00571701|Secondary|Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.|Percent of patients of each gender with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline|Baseline to12 months|All patients who completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percent responders|||Number
1241320|NCT00571701|Secondary|Percent of Patients With Positive Response to Treatment|Percent of patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline|Baseline to 12 months|All patients that completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percent responders|||Number
1241321|NCT00571701|Primary|Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline|Change in mean growth rates during the last 3 months of the first treatment period compared to the mean values at baseline. Endoscopy and removal of all tumor was done every 3 months. Growth rate is calculated as the scored amount of papilloma recurrence in a 3 month period divided by the exact number of days since last endoscopy and removal of all tumor.|Baseline to 12 months|All patients in each arm who completed the first 1 year treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percent change in mean growth rate||Standard Deviation|Mean
1241322|NCT00571688|Primary|Number of Relapse-related Events Normalized to Unit Time|The outcome was total number of events divided by number of months (normalized to unit time). This was be calculated by dividing the number of relapse related events by the number of months of participation. Relapse related events included: (1) YMRS score > 14 or MADRS > 15; (2) 20% or greater increase in the YMRS or MADRS scores from the previous study visit; (3) urgent care visit (psychiatric hospitalization; emergency department visit; referral for respite care, partial hospitalization, or intensive outpatient treatment) due to worsening mood symptoms; (4) a Clinical Global Impression Severity of Illness score >3; (5) syndromal relapse (Diagnostic and Statistical Manual of Mental Disorders, 4th Editionfor manic, hypomanic, major depressive, or mixed episode met); (6) withdrawal from the study due to inefficacy; and (7) necessary clinical medication adjustments (NCAs).|12 months|All randomized participants were analyzed.|||Events/month||Standard Deviation|Mean
1241323|NCT00571662|Secondary|Kinetics of Immunologic Reconstitution After Allogeneic Transplantation||at day 100 post transplantation||||percentage of cells in peripheral blood||Full Range|Median
1241324|NCT00571662|Secondary|Responses to Therapy|event-free and overall survival at 12 months|every 6 mo. up to 2 years||||Percent of Participants|||Number
1241325|NCT00571662|Secondary|Incidence of Acute and Chronic Graft-versus-host Disease|Incidence of acute and chronic graft-versus-host disease. Acute GVHD usually occurs during the first three months following transplant. Chronic GVHD usually develops after the third month post-transplant.|twice weekly until day 100 up to 1 year post transplant||||Percent of Particpants|||Number
1241326|NCT00571662|Primary|Toxicity for the Combination of Pentostatin and Low Dose Total Body Irradiation (TBI)||Conditioning regimen to count recovery (D + 28 post transplant)||||Participants|||Count of Participants
1241327|NCT00571662|Primary|Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting|the efficacy of the regimen as determined by engraftment rate and establishment of donor hematopoietic chimerism at day +28 and day +70.|days +28 and +70||||percent of participants||Full Range|Median
1241328|NCT00571649|Secondary|Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)|Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.|Up to Day 10 + 5 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
1241329|NCT00571649|Secondary|Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)|Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding|Up to Day 35 + 6 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
1241330|NCT00571649|Secondary|Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days|All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.|Up to Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
1241331|NCT00571649|Secondary|Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days|The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|Per Protocol Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations|||Percentage of participants|||Number
1241332|NCT00571649|Secondary|Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days|The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35|||Percentage of participants|||Number
1241408|NCT00570765|Primary|Alkaline Phosphatase (AP) Levels|Percent (%) Change in Serum Alkaline Phosphatase from baseline to end of study (EOS)at Day 85.|Baseline and 12 weeks|Per Statistical Analysis Plan (SAP): patients will be analyzed by the treatment group to which they were randomly assigned - intention to treat (ITT) principle.|||Percent change||Standard Error|Mean
1241333|NCT00571649|Secondary|Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90|Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.|At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
1241334|NCT00571649|Secondary|Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days|Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events|Up to Day 10 + 5 days|Participants valid for safety analysis, with adequate assessment of VTE (to Day 10 within 48 hours of study drug), met inclusion criteria, and no major protocol deviations; expanded to include participants who had major bleeding or clinically relevant non-major bleeding events and met all criteria for PP except valid assessment of thromboembolism.|||Percentage of participants|||Number
1241335|NCT00571649|Secondary|Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days|Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants with major and clinically relevant bleeding events.|||Percentage of participants|||Number
1241336|NCT00571649|Secondary|Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90|Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90|At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
1241337|NCT00571649|Secondary|Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).|Up to Day 10 + 5 days|modified Intent-to-Treat (mITT) Day 10 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10) expanded to include participants who had an assessment of all deaths, including not VTE-related|||Percentage of participants|||Number
1241338|NCT00571649|Secondary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|modified Intent-to-Treat (mITT) Day 10: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10|||Percentage of participants|||Number
1241339|NCT00571649|Secondary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants who had an assessment of all deaths, including not VTE-related|||Percentage of participants|||Number
1241340|NCT00571649|Primary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|Per Protocol (PP) Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations.|||Percentage of participants|||Number
1241341|NCT00571649|Primary|Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35|||Percentage of participants|||Number
1241342|NCT00571493|Secondary|Progression-free Survival (PFS), and Overall Survival (OS)|To obtain a preliminary estimate of PFS and OS. Overall survival (OS) is defined as time from the first chemotherapy administered on the transplant trial until death from any cause. Progression free survival (PFS)is defined as time from therapy until relapse, progression, or death from any cause.|one year post autologous hematopoietic stem cell transplantation (ASCT) , 5 years post ASCT|There were 38 evaluable patients at one year post autologous hematopoietic stem cell transplantation (ASCT).|||percentage of participants||95% Confidence Interval|Number
1241343|NCT00571493|Secondary|Preliminary Estimate of Overall Response Rate (ORR)|To obtain a preliminary estimate of overall response rate (ORR). The overall response rate is calculated as the number of patients who achieved complete response (CR) and partial response (PR) divided by the total number of evaluable patients.|100 day post autologous hematopoietic stem cell transplantation (ASCT), one year post ASCT|"One hundred days after autologous hematopoietic stem cell transplantation (ASCT), 40 participants were evaluable for response.~At year one post ASCT, 38 participants were evaluable for response. Participants evaluable for the secondary endpoints (Phase II) are those who complete the transplant procedure."|||participants|||Number
1241345|NCT00571428|Secondary|Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point|Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. The measure compares the change from pre-dose reading to each post-dose time point.|immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose|Intent to treat population|||liters||Standard Deviation|Mean
1241346|NCT00571428|Secondary|Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing|Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration.|pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose|Intent to treat population|||minutes||Standard Deviation|Mean
1241347|NCT00571428|Secondary|Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing|Time to a 12 percent improvement in forced expiratory volume in one second (FEV1) AND a 200 milliliter increase in FEV1 within 12 hours of dosing. Only patients who met both conditions are included|up to 12 hours post dose|Intent to treat population. Limited to patients who met both criteria: a 12 percent increase in FEV1 and a 200 milliliter increase in FEV1|||minutes||Full Range|Median
1241348|NCT00571428|Secondary|Time to Onset of 15 Percent Response Within 12 Hours of Dosing|Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included.|12 hours post first dose|Intent to treat population. Limited to those patients who had a 15% response.|||minutes||Full Range|Median
1241349|NCT00571428|Secondary|Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 12 hours post-dose, and reports the largest change during that time.|12 hours||||liters||Standard Deviation|Mean
1241350|NCT00571428|Secondary|Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose.|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function and reports the highest percent found within 12 hours of dosing.|12 hours|Intent to treat population|||percent of predicted FEV1||Standard Deviation|Mean
1241351|NCT00571428|Secondary|Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the change in percent of the estimated healthy lung function at specified time points compared to the pre-dose value.|Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population|||percent of predicted FEV1||Standard Deviation|Mean
1241352|NCT00571428|Secondary|Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function at specified time points.|Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population|||Percent of Predicted FEV1||Standard Deviation|Mean
1241353|NCT00571428|Secondary|Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the change in FEV1 readings between pre-dose and various time points within 24 hours post-dose.|Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population|||liters||Standard Deviation|Mean
1241354|NCT00571428|Secondary|Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the FEV1 readings taken pre-dose and at various time points within 24 hours post-dose.|pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose|Intent to treat population|||liters||Standard Deviation|Mean
1241355|NCT00571428|Secondary|Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 24 hours post-dose, which represents the trough in dose level.|pre-dose and 24 hours post-dose|Intent to treat population|||liters||Standard Deviation|Mean
1241356|NCT00571428|Secondary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken between 12 and 24 hours of dosing.|12-24 hours|Intent to treat population|||liters||Standard Deviation|Mean
1241357|NCT00571428|Secondary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 12 hours of dosing.|0-12 hours|Intent to treat population|||liters||Standard Deviation|Mean
1241358|NCT00571428|Primary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.|0-24 hours post dose|Intent to treat population|||liters||Standard Deviation|Mean
1241385|NCT00571038|Secondary|Change in Alcohol Use|"Mean/SE change in score on:~Scale: Alcohol Use Disorders Identification Test (AUDIT) Construct: Alcohol use and abuse Minimum Score: 0 Maximum Score: 12 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241359|NCT00571324|Secondary|Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma intact glucagon-like Peptide-1 (GLP-1) levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean intact GLP-1 area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.|||pmol*min/L||Standard Error|Mean
1241360|NCT00571324|Secondary|Mean Plasma Glucagon Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma glucagon area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.|||pg*min/dL||Standard Error|Mean
1241361|NCT00571324|Secondary|Mean Plasma Insulin Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.|||pmol*min/L||Standard Error|Mean
1241362|NCT00571324|Primary|Mean Blood Glucose Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on fasting blood glucose levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean blood glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.|||mmol*min/L||Standard Error|Mean
1241363|NCT00571194|Primary|Pharmacokinetics||24 hours|Data was not collected||||||
1241364|NCT00571103|Primary|The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG).|The YBOCS-PG (Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling) is used to assess the range and severity of PG symptoms. The scale is a modification of the YBOCS originally developed by Goodman et al. (1989) for use in rating severity and change in subjects with Obsessive Compulsive Disorder. This adaptation is a 10-item clinician-rated questionnaire, which rates (on a 5-point scale from 0 to 4) time spent, distress, interference, resistance, and control in relation to PG urges and behaviors. The scale ranges from 0 to 40 with a higher score representing increased severity in PG.|8 weeks minus baseline||||units on a scale||Standard Error|Mean
1241365|NCT00571103|Secondary|The Secondary Efficacy Evaluations Will Include the G-SAS (Gambling Symptom Assessment Scale), Clinical Global Impression – Improvement Scale (CGI-I) , and the CGI-S Clinical Global Impression – Severity Scale.|The G-SAS is a 12 item self-report instrument that reflects the subjects urges to gamble and the subjects gambling behavior. Each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms) with a total score range from 0 to 48. The CGI-I is a 7 point scale requiring the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill patients.|8 weeks minus baseline|A total of 39 participants were screened by phone and 5 failed to meet screening criteria and were excluded; 6 did not return for the baseline visit because of follow-up loss or choosing to discontinue participation. of the remaining 28 patients, 1 discontinued and another was lost to follow-up after the baseline visit. That left 26 subjects.|||units on a scale||Standard Error|Mean
1241366|NCT00571064|Secondary|Change From Baseline in DAD Total Score by Visit|The DAD was a 10 domain 40-item scale that measured a participant’s ability to initiate, plan, organize, and perform both basic and instrumental activities of daily living. These domains were: hygiene (7 items), dressing (5 items), continence (2 items), eating (3 items), meal preparation (3 items), telephoning (4 items), going on an outing (5 items), finance (4 items), medication (2 items), and leisure (5 items). The three responses to the DAD items were “No, Yes, and N/A”. A “No” answer scored 0 and a “Yes” answer scored 1. The scoring range was 0-40, with a higher score indicating less disability (better quality of life). If N/A was selected then it was treated as missing. When there were items with missing values, the domain sub-scores and the total score were imputed. Domain sub-scores were summed to yield a total raw score. This was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score can be calculated in the similar approach.|Baselinw, Week 6 (Visit 3) and Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
1241386|NCT00571038|Secondary|Change in Satisfaction With Blood Pressure Treatment|"Mean/SE change in score on:~Scale: Modified Holmes-Ravnor Satisfaction with Decision (SWD) Construct: Satisfaction with current blood pressure treatment Minimum Score: 1 Maximum Score: 5 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241367|NCT00571064|Secondary|Disability Assessment in Dementia (DAD) Total Score by Visit|The DAD was a 10 domain 40-item scale that measured a participant’s ability to initiate, plan, organize, and perform both basic and instrumental activities of daily living. These domains were: hygiene (7 items), dressing (5 items), continence (2 items), eating (3 items), meal preparation (3 items), telephoning (4 items), going on an outing (5 items), finance (4 items), medication (2 items), and leisure (5 items). The three responses to the DAD items were “No, Yes, and N/A”. A “No” answer scored 0 and a “Yes” answer scored 1. The scoring range was 0-40, with a higher score indicating less disability (better quality of life). If N/A was selected then it was treated as missing. When there were items with missing values, the domain sub-scores and the total score were imputed. Domain sub-scores were summed to yield a total raw score. This was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score can be calculated in the similar approach.|Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
1241368|NCT00571064|Secondary|Change From Baseline in ADRQL Total Score by Visit|The ADRQL was an observer-rated quality of life instrument that measured the following domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. The ADRQL was a 47-item questionnaire with five domains: relating to and being around other people (ADRQL-A; 12 items), a person’s special identity and important relationships (ADRQL-B; 8 items), different types of behavior (ADRQL-C; 15 items), usual activities (ADRQL-D; 5 items), and behavior in a person’s living environment (ADRQL-E; 7 items). Domain sub-scores were summed to yield a total raw score, which was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score could be calculated in the similar approach. Higher scores reflected a better quality of life. Change from Baseline in ADRQL Total Score at Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.|Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
1241369|NCT00571064|Secondary|Alzheimer Disease-related Quality of Life (ADRQL) Total Score by Visit|The ADRQL was an observer-rated quality of life instrument that measured the following domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. The ADRQL was a 47-item questionnaire with five domains: relating to and being around other people (ADRQL-A; 12 items), a person’s special identity and important relationships (ADRQL-B; 8 items), different types of behavior (ADRQL-C; 15 items), usual activities (ADRQL-D; 5 items), and behavior in a person’s living environment (ADRQL-E; 7 items). Domain sub-scores were summed to yield a total raw score, which was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score could be calculated in the similar approach. Total score ranges from 0-100 where higher scores reflected a better quality of life.|Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
1241370|NCT00571064|Secondary|Change From Baseline in NPI-8 Total Score by Visit|The NPI-8 was an 8-item scale that assessed eight behavioral domains: delusions, hallucinations, agitation, depression, anxiety, apathy, irritability, and aberrant motor behavior. The frequency (0 to 4) and severity (0 to 3) of each domain were assessed; the sub-score for each domain was calculated as the product of the frequency and severity rating. The total score for the NPI was calculated as the sum of the domain sub-score, range from 0 to 96, with higher scores indicating greater behavior disturbances. Change from Baseline in NPI-8 Total Score at Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.|Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
1241371|NCT00571064|Secondary|Neuropsychiatric Inventory (NPI-8) Total Score by Visit|The NPI-8 was an 8-item scale that assessed eight behavioral domains: delusions, hallucinations, agitation, depression, anxiety, apathy, irritability, and aberrant motor behavior. The frequency (0 to 4) and severity (0 to 3) of each domain were assessed; the sub-score for each domain was calculated as the product of the frequency and severity rating. The total score for the NPI was calculated as the sum of the domain sub-score, range from 0 to 96, with higher scores indicating greater behavior disturbances.|Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
1241372|NCT00571064|Primary|Change From Baseline in MMSE Total Score by Visit|The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluated orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the ITT population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the LOCF from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF. Change from Baseline in MMSE Total Score at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.|Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
1241373|NCT00571064|Secondary|Change From Baseline in CAS Total Time by Visit|The CAS was a validated tool that measured the time caregivers spent aiding Alzheimer’s participants with their day-to-day activities. The CAS recorded time spent on six activities of daily living, communicating with the person, using transportation, dressing, eating, looking after one’s appearance, and supervising the person. Caregivers were asked to report the amount of time spent on each activity during a 'typical' caregiving day. Total time for the CAS was calculated as the sum of the sub-item times. Change from Baseline in CAS Total Time at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.|Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at Week 12 included ITT population with LOCF.|||Hours/day||Standard Deviation|Mean
1241374|NCT00571064|Secondary|Caregiver Activity Survey (CAS) Total Time by Visit|The CAS was a validated tool that measured the time caregivers spent aiding Alzheimer’s participants with their day-to-day activities. The CAS recorded time spent on six activities of daily living, communicating with the person, using transportation, dressing, eating, looking after one’s appearance, and supervising the person. Caregivers were asked to report the amount of time spent on each activity during a 'typical' caregiving day. Total time for the CAS was calculated as the sum of the sub-item times.|Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Hours/day||Standard Deviation|Mean
1241375|NCT00571064|Primary|Mini Mental State Examination (MMSE) Total Scores by Visit|The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluate orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the Intent-to-Treat (ITT) population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the last observation carried forward (LOCF) from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF.|Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or Early Termination (ET) Visit, Week 12 LOCF (Study Endpoint)|ITT population with LOCF included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable.|||Scores on a scale||Standard Deviation|Mean
1241376|NCT00571038|Secondary|Change in Patient Activation|"Mean/SE change in score on:~Scale: Hibbard Patient Activation Measure (PAM) Construct: Level of patient activation and engagement in health care Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241377|NCT00571038|Secondary|Change in Health Opinions|"Mean/SE change in overall score on:~Scale: Krantz Health Opinion Survey Construct: Opinions about healthcare and healthcare providers Minimum Score: 0 Maximum Score: 16 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241378|NCT00571038|Secondary|Change in Social Support|"Mean/SE change in overall score on:~Scale: Medical Outcomes Study (MOS) Social Support Survey Construct: Overall measure of social support, including tangible, affectionate, positive social interaction, and emotional/informational Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241379|NCT00571038|Secondary|Change in Self Efficacy|"Mean/SE change in score on:~Scale: Schwarzer General Perceived Self-Efficacy Construct: Perceived self-efficacy Minimum Score: 10 Maximum Score: 40 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241380|NCT00571038|Secondary|Change in Medication Adherence|"Mean/SE change in score on:~Scale: Morisky Adherence; questions modified to ask specifically about blood pressure medication Construct: Adherence to prescribed medication-taking regimen Minimum Score: 0 Maximum Score: 4 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241381|NCT00571038|Secondary|Change in Fruit and Vegetable Intake|Mean/SE change in # of servings per day; questions taken from the 2009 Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||servings of fruits & vegetables per day||Standard Error|Mean
1241382|NCT00571038|Secondary|Change in Daily Steps|Mean/SE change in # of steps per day (self report)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||steps per day||Standard Error|Mean
1241383|NCT00571038|Secondary|Change in Physical Activity Level|"Mean/SE change in score on:~Scale: International Physical Activity Questionnaire (IPAQ), Metabolic Equivalent of Task (MET) Construct: Total metabolic equivalents (a measure of energy expenditure) in the last 7 days Minimum Score: 0 Maximum Score: Not applicable; based on physical activity done Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||METS||Standard Error|Mean
1241384|NCT00571038|Secondary|Change in Sodium Intake|"Mean/SE change in score on:~Scale: Hopkins Dietary Questionnaire (only the dietary salt avoidance questions) Construct: Dietary sodium intake Minimum Score: 2 Maximum Score: 12 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241387|NCT00571038|Secondary|Change in Hypertension Attitudes|"Mean/SE change in score on:~Scale: Not applicable; series of agree/disagree statements that we wrote Construct: Attitudes around blood pressure diagnosis, treatment (including lifestyle changes), and seriousness of the condition Minimum Score: 12 Maximum Score: 60 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241388|NCT00571038|Secondary|Change in Hypertension Knowledge|"Mean/SE change in score on:~Scale: Hypertension Evaluation of Lifestyle and Management (HELM) Construct: Knowledge of hypertension and lifestyle factors related to hypertension Minimum Score: 0 Maximum Score: 14 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
1241389|NCT00571038|Secondary|Change in Number of Blood Pressure Medications|Change in mean # of prescription blood pressure medications|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||blood pressure medications||Standard Error|Mean
1241390|NCT00571038|Secondary|Non-Clinic Blood Pressure Checks|% reporting non-clinic blood pressure (BP) checks at least once a month|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||percentage of participants|||Number
1241391|NCT00571038|Secondary|Change in Time Since Last Physician Visit|Change in mean # of months since last visit to a physician|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||months (since last visit)||Standard Error|Mean
1241392|NCT00571038|Secondary|Change in Health Status|"Response to the question How would you rate your general health status?. Response options are scored as follows.~Excellent~Very Good~Good~Fair~Poor We report the change in health status from baseline to 12 months."|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||units on a scale (range 1-5)||Standard Error|Mean
1241393|NCT00571038|Secondary|Change in BMI|Mean/SE change in Body Mass Index (BMI) (kg/m2)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||kg/m2||Standard Error|Mean
1241394|NCT00571038|Secondary|Change in Weight|Mean/SE change in weight, measured in pounds (lbs)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||pounds||Standard Error|Mean
1241395|NCT00571038|Secondary|Change in Diastolic Blood Pressure|Mean/SE change in diastolic blood pressure|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||mm Hg||Standard Error|Mean
1241396|NCT00571038|Primary|Change in Systolic Blood Pressure|Mean/Standard Error (SE) change in systolic blood pressure|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||mm Hg||Standard Error|Mean
1241397|NCT00570960|Primary|30 Day All Cause Mortality|30 day all cause mortality|30 days||||participants|||Number
1241398|NCT00570921|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as a complete response, partial response, or stable disease (CR, PR, SD) by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks or more.|Duration of response or stable disease for 24 weeks or more||||participants|||Number
1241399|NCT00570921|Secondary|Objective Response Rates|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Evaluated 60 days after therapy start||||participants|||Number
1241400|NCT00570921|Primary|Time to Progression||Duration of time start of treatment to time of documented progression or death||||months||95% Confidence Interval|Median
1241401|NCT00570908|Primary|Progression Free Survival|Progression free survival is defined as form initiation of WBRT with capecitabine to the time of first documented progression at any site (CNS or non-CNS site) or death due to any cause, where progression is defined stringently by progression in either CNS or extra-CNS metastases.|2 years|5 patients progressed during the study treatment. 7 patients were off study treatment early due to AE or withdrawal but 6 of them were followed for the survival outcome, 1 was lost to follow up after 3.5 months observation (censored data).|||months||95% Confidence Interval|Median
1241402|NCT00570778|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events|Additional information about adverse events can be found in the Adverse Event Section.|47 days|Safety population includes all participants who received at least 1 dose of study drug.|||Participants|||Number
1241403|NCT00570778|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7|Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.|Day 7|Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1241404|NCT00570778|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.|Baseline, Day 7|Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1241405|NCT00570765|Secondary|Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites||12 weeks|||||||
1241409|NCT00570739|Secondary|Percent of Subjects Meeting Type 2 Diabetes Criteria (Fasting Plasma Glucose >or= to 126 mg/dL or Plasma Glucose >or= to 200 mg/dL Post 2 Hr Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241410|NCT00570739|Secondary|Percent Achievement of Hs-C-Reactive Protein <2.0 mg/L in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 2.0 mg/L From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241411|NCT00570739|Secondary|Percent Achievement of <140 mg/dL Plasma Glucose Post 2 Hour Glucose Tolerance Test and Fasting Plasma Glucose <110 mg/dL in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241412|NCT00570739|Secondary|Percent Achievement of <100 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 100 mg/dL From Baseline to 4, 8, 12 and 16 Weeks||Baseline to 4, 8, 12 and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241413|NCT00570739|Secondary|Percent Achievement of <110 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 110 mg/dL From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF|||Percent of participants|||Number
1241414|NCT00570739|Secondary|Percent Achievement of <140 mg/dL Plasma Glucose 2 Hours Post the Oral Glucose Tolerance Test in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was >or= to 140 mg/dL From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241415|NCT00570739|Secondary|Area Under the Curve for Plasma Glucose From 0 to 120 Minutes During the Oral Glucose Tolerance Tests in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL*hr||Standard Error|Least Squares Mean
1241416|NCT00570739|Secondary|Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Change in Ratio||Standard Error|Least Squares Mean
1241417|NCT00570739|Secondary|Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||lb||Standard Error|Least Squares Mean
1241418|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241419|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241420|NCT00570739|Secondary|Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||ng/mL||Standard Error|Least Squares Mean
1241421|NCT00570739|Secondary|Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||uIU/mL||Standard Error|Least Squares Mean
1241422|NCT00570739|Secondary|Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241423|NCT00570739|Secondary|Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241424|NCT00570739|Secondary|Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241425|NCT00570739|Secondary|Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks||||ng/mL||Standard Error|Least Squares Mean
1241426|NCT00570739|Secondary|Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241427|NCT00570739|Secondary|Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241428|NCT00570739|Secondary|Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241429|NCT00570739|Secondary|Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241430|NCT00570739|Secondary|Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||nm||Standard Error|Least Squares Mean
1241431|NCT00570739|Secondary|Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. These 16 week analyses are both LOCF and no LOCF.|||nmol/L||Standard Error|Least Squares Mean
1241432|NCT00570739|Secondary|Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Inter-Quartile Range|Median
1241433|NCT00570739|Secondary|Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Inter-Quartile Range|Median
1241434|NCT00570739|Secondary|Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241435|NCT00570739|Secondary|Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241436|NCT00570739|Secondary|Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241437|NCT00570739|Secondary|Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241438|NCT00570739|Secondary|Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241439|NCT00570739|Secondary|Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241440|NCT00570739|Secondary|Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables.|||Percentage of change||Standard Error|Least Squares Mean
1241441|NCT00570739|Secondary|Percent of Subjects Achieving Hs-C-Reactive Protein Goal of <2.0 mg/L When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241442|NCT00570739|Secondary|Percent of Subjects Achieving 2-Hr. Post Meal Glucose Goal of <180 mg/dL When Given to Drug-naïve, Diabetic Subjects From Baseline to Week 16||Baseline to Week 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241443|NCT00570739|Secondary|Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change|||Number
1241444|NCT00570739|Secondary|Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT||Baseline vs. 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL*hr||Standard Error|Least Squares Mean
1241445|NCT00570739|Primary|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Last Observation Carried Forward was used for 16 week analyses.|||Percentage of change in LDL-C||Standard Error|Least Squares Mean
1241446|NCT00570739|Secondary|Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Ratio||Standard Error|Least Squares Mean
1241447|NCT00570739|Secondary|Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||lb||Standard Error|Least Squares Mean
1241448|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics||Baseline to Weeks 8, and 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241449|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects||Baseline to Weeks 8, and 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241450|NCT00570739|Secondary|Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects||Baseline to 4, 8, 12 and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of particpants|||Number
1241451|NCT00570739|Secondary|Percent of Subjects Achieving HbA1c Goal of <7.0% at Weeks 4, 8, 12, and 16 if Baseline HbA1c Was > or = to 7.0% When Given to Drug-naïve, Diabetics||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
1241452|NCT00570739|Primary|Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.||Baseline to 16 weeks|The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was used.|||Percentage of change of hemoglobin A1C||Standard Error|Least Squares Mean
1241453|NCT00570739|Secondary|Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241454|NCT00570739|Secondary|Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241455|NCT00570739|Secondary|Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241456|NCT00570739|Secondary|Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||nm||Standard Error|Least Squares Mean
1241457|NCT00570739|Secondary|Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||nmol/L||Standard Error|Least Squares Mean
1241458|NCT00570739|Secondary|Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change in Apo C3||Standard Error|Least Squares Mean
1241459|NCT00570739|Secondary|Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change in Apo B||Standard Error|Least Squares Mean
1241460|NCT00570739|Secondary|Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change in Apo A-1||Standard Error|Least Squares Mean
1241591|NCT00569803|Secondary|Number of Participants With Injection Site Reactions|Participants were assessed for erythema, heat, pain, pruritis and swelling at the injection sites and were characterized by the investigator as mild, moderate or severe reactions.|0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116|All treated participants|||participants|||Number
1241461|NCT00570739|Secondary|Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change of TG||Inter-Quartile Range|Median
1241462|NCT00570739|Secondary|Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change of TC||Standard Error|Least Squares Mean
1241463|NCT00570739|Secondary|Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
1241464|NCT00570739|Secondary|Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||percentage of change in non-HDL||Standard Error|Least Squares Mean
1241465|NCT00570739|Secondary|The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||percentage of change in LDL-C||Standard Error|Least Squares Mean
1241466|NCT00570739|Secondary|2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||ng/mL||Standard Error|Least Squares Mean
1241467|NCT00570739|Secondary|2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||uIU/mL||Standard Error|Least Squares Mean
1241468|NCT00570739|Secondary|2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241469|NCT00570739|Secondary|1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241470|NCT00570739|Secondary|30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241471|NCT00570739|Secondary|Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||ng/mL||Standard Error|Least Squares Mean
1241472|NCT00570739|Secondary|Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||uIU/mL||Standard Error|Least Squares Mean
1241473|NCT00570739|Secondary|Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
1241474|NCT00570739|Secondary|Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks.||Baseline to 4, 8, 12, and 16 weeks|The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was not used.|||Percentage of change in HbA1c||Standard Error|Least Squares Mean
1241475|NCT00570713|Secondary|Best Overall Response Rate|Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.|Baseline to response up to 21 months||||percentage of participants|||Number
1241476|NCT00570713|Secondary|Progression-free Survival|Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.|1-21 Months||||Months||95% Confidence Interval|Median
1241477|NCT00570713|Primary|Overall Survival (OS)|This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.|1-21 Months||||Months||95% Confidence Interval|Median
1241478|NCT00570700|Secondary|Number of Subjects With Dasatinib Toxicity Using Common Terminology Criteria (CTC) (v. 3.0)|Due to relatively poor drug tolerance and relatively rapid PSA increases in most patients it was not feasible to continue patients on treatment until there was radiographic evidence of disease progression.|From initial date of treatment through study completion, up to 2 years|12 of the 27 evaluable participants discontinued therapy because of toxicity.|||Participants|||Count of Participants
1241479|NCT00570700|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression, defined as the interval from the first day of dasatinib treatment until either (1) there has been a 50% increase in PSA above the treatment nadir, with a minimum of 5ng/mL, or (2) a 25% increase in PSA level above pretreatment levels, with a minimum of 5ng/mL. All PSA-based assessments require a confirmatory level no more than 1 month later.|From initial date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years|Data not collected due to relatively poor drug tolerance and relatively rapid PSA increases in most patients as it was not feasible to continue patients on treatment.||||||
1241480|NCT00570700|Primary|Number of Subjects With Disease Control (DC) (Based on PSA, Bone Scan, FACT-P, RECIST)|"A “positive effect” will be defined as a complete response, partial response, or stable disease. “Lack of positive effect” will be defined as progressive disease. Subjects with a mixed response should be continued on therapy until they either fulfill the criteria for positive effect or lack of positive effect, with evaluation every 56 days.~The disease control (DC) rate was evaluated as a composite endpoint of the treatment effect on four parameters: 1) Prostate-specific antigen (PSA), 2) measurable disease (if present) by RECIST criteria, 3) bone scan, and 4) quality-of-life as measured by the FACT-P questionnaire."|From day 56 (8 weeks) and every 8 weeks thereafter until the date of first documented progression or date of death from any cause, whichever came first, assessed until death, the patient withdraws consent, or the study ends, up to 2 years|27 subjects were evaluable for response.|||Participants|||Count of Participants
1241481|NCT00570687|Primary|EGP AOC0-480 - Meal Challenge|EGP area over the curve from 0 to 480 minutes postdose|0-480 minutes|Amendment 1: Subjects with type 2 diabetes. All subjects crossed over to lispro treatment. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; AOC could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.|||µmol/kg||Standard Deviation|Mean
1241482|NCT00570687|Primary|Minimum EGP - Meal Challenge|Minimum calculated EGP per subject as change from baseline|0-480 minutes|Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.|||µmol/kg/min||Standard Deviation|Mean
1241483|NCT00570687|Primary|Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge|Time to minimum EGP post dose|0-480 minutes|Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.|||Minutes||Full Range|Median
1241484|NCT00570674|Secondary|Change in FACT-H&N Score From Baseline to 24 Months|"The FACT-H&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients. It is comprised of 27 core items from the FACT-G (Version 4), an established survey which assesses the impact of cancer therapy in four domains: physical, social/family, emotional, and functional.~[Cella, D, et al. JCO 1993(11)]. It is supplemented with a validated measure of 12 site specific items to assess for head and neck related symptoms. [D’Antonio L, Zimmerman G, et al. Cancer 1996 (77)] Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score (range: 0-156). Higher scores represent better QoL. The change score is calculated as post-baseline less baseline; therefore, a negative value indicates a decrease in score and correspondingly a decrease in QoL."|Baseline and 24 months|The analysis dataset is comprised of patients with evaluable data at the 2 assessment timepoints: baseline and 24 months.|||units on a scale||Full Range|Median
1243768|NCT00554099|Secondary|Recurrent Diverticulitis, Percentage, ITT Population, Week 12|At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).|12 Weeks|ITT Population|||Percentage of Participants|||Number
1241485|NCT00570674|Secondary|Change in FACT-H&N Score From Baseline to 12 Months|"The FACT-H&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients. It is comprised of 27 core items from the FACT-G (Version 4), an established survey which assesses the impact of cancer therapy in four domains: physical, social/family, emotional, and functional.~[Cella, D, et al. JCO 1993(11)]. It is supplemented with a validated measure of 12 site specific items to assess for head and neck related symptoms. [D’Antonio L, Zimmerman G, et al. Cancer 1996 (77)] Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score (range: 0-156). Higher scores represent better QoL. The change score is calculated as post-baseline less baseline; therefore, a negative value indicates a decrease in score and correspondingly a decrease in QoL."|Baseline and 12 months|The analysis dataset is comprised of patients with evaluable data at the 2 assessment timepoints: baseline and 12 months.|||units on a scale||Full Range|Median
1241486|NCT00570674|Secondary|Change in FACT-H&N Score From Baseline to 6 Months|"he FACT-H&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients. It is comprised of 27 core items from the FACT-G (Version 4), an established survey which assesses the impact of cancer therapy in four domains: physical, social/family, emotional, and functional.~[Cella, D, et al. JCO 1993(11)]. It is supplemented with a validated measure of 12 site specific items to assess for head and neck related symptoms. [D’Antonio L, Zimmerman G, et al. Cancer 1996 (77)] Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score (range: 0-156). Higher scores represent better QoL. The change score is calculated as post-baseline less baseline; therefore, a negative value indicates a decrease in score and correspondingly a decrease in QoL."|Baseline and 6 months|The analysis dataset is comprised of patients with evaluable data at the 2 assessment timepoints: baseline and 6 months.|||units on a scale||Full Range|Median
1241487|NCT00570674|Secondary|Change in FACT-H&N Score From Baseline to 4 Months|"The FACT-H&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients. It is comprised of 27 core items from the FACT-G (Version 4), an established survey which assesses the impact of cancer therapy in four domains: physical, social/family, emotional, and functional.~[Cella, D, et al. JCO 1993(11)]. It is supplemented with a validated measure of 12 site specific items to assess for head and neck related symptoms. [D’Antonio L, Zimmerman G, et al. Cancer 1996 (77)] Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score (range: 0-156). Higher scores represent better QoL. The change score is calculated as post-baseline less baseline; therefore, a negative value indicates a decrease in score and correspondingly a decrease in QoL."|baseline and 4 months|The analysis dataset is comprised of patients with evaluable data at the 2 assessment timepoints: baseline and 4 months.|||units on a scale||Full Range|Median
1241488|NCT00570674|Secondary|Duration PEG Therapy|Estimated as the time from registration to the date of PEG removal.|Assessed until time of PEG removal which was up to 18.4 months in this study cohort.|The analysis dataset is comprised of all patients with date of PEG removal (evaluable). Reporting within dose cohorts is not preferred given the small sample sizes.|||months||Full Range|Mean
1241489|NCT00570674|Secondary|2-Year Overall Survival [Phase I]|2-year overall survival is the proportion of patients alive at 2-years from study entry.|All patients were followed for survival for a minimum of 2 years. Median survival follow-up was 44.7 months (range 10-70) in this study cohort.|The analysis dataset is comprised of all treated phase I patients. Reporting within dose cohorts is not preferred given the small sample sizes.|||proportion of participants||95% Confidence Interval|Number
1241490|NCT00570674|Secondary|Overall Response Rate [Phase I]|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|The primary re-staging assessment for response occurred 8-10 weeks following completion of treatment. Treatment duration was a mean (range) of 7.8 weeks (6.6-10.1).|The analysis dataset is comprised of all treated phase I patients. Reporting within dose cohorts is not preferred given the small sample sizes.|||proportion of participants||95% Confidence Interval|Number
1241491|NCT00570674|Primary|2-Year Disease-Free Survival [Phase II]|Disease-free survival (DFS) is defined as the time from registration to the earlier of disease recurrence or death from any cause. Patients alive without a recurrence are censored at the date of last disease evaluation. 2-year disease-free survival is the probability of patients remaining alive and progression-free at 2-years from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target.|Disease assessments occurred 8-10 weeks following treatment end then every 4-6 weeks (yr 1), every 8-10 weeks (yr 2), quarterly (yr 3) and semiannually up to 2 yrs since last pt enrolled.|The phase II portion planned to enroll 34 participants including the phase I expansion cohort but the study did not continue beyond phase I.||||||
1241492|NCT00570674|Primary|Dose Limiting Toxicity (DLT) [Phase I]|Dose limiting toxicities (DLT) were defined as treatment-related: 1) grade 3-4 non-hematological toxicity excluding untreated nausea, vomiting and diarrhea; dysphagia, esophagitis, mucositis/stomatitis, dermatitis/rash, 2) Grade 3 or greater febrile neutropenia occurring during chemoradiotherapy, 3) Grade 4 neutropenia lasting >/= 7 days and 4) Grade 3 thrombocytopenia. Grade 4 toxicities resulting in a treatment breaks > 7 days were considered DLTs.|Adverse event assessments occurred weekly on treatment; The observation period for DLT evaluation incorporated the 7 weeks of treatment.|The analysis dataset is comprised of all treated patients in the dose escalation cohorts.While no DLTs were observed in the first 3 DL 1 patients, the cohort was expanded to 6 patients due to safety and tolerability concerns. Upon further review, it was resolved that the Abraxane dose should not be increased in the setting of concurrent Erbitux.|||Participants with DLT|||Number
1241493|NCT00570674|Primary|Abraxane Maximum Tolerated Dose (MTD) [Phase I]|The Abraxane MTD in combination with carboplatin and concurrent IMRT is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of participants experience a DLT. If no DLTs are observed then the MTD is not reached but the highest dose may then be the recommended phase II dose.|Adverse event assessments occurred weekly on treatment; The observation period for MTD evaluation incorporated the 7 weeks of treatment.|The MTD was not reached on this trial but the recommended phase II dose was the highest dose of Abraxane evaluated.|||mg weekly|||Number
1241494|NCT00570531|Secondary|The Proportion of Toxicities Experienced by Participants|To assess the toxicity of this regimen.|Every three weeks for one year|The study was unable to accrue the number of patients necessary to analyze the objective.||||||
1241495|NCT00570531|Secondary|The Number of Patients Cancer Free at the Time of Surgery|Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery.|1 year|The study was unable to accrue the number of patients necessary to analyze the objective.||||||
1241496|NCT00570531|Primary|Disease Free Survival Time|The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.|5 years|The study was unable to accrue the number of patients necessary to analyze the primary objective.||||||
1241497|NCT00570505|Post-Hoc|Change in Quality of Life (5 Years)|Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 5 years in IWQOL-Lite Total Score is reported.|5 years|Intent-to-treat (ITT)|||units on a scale||Standard Deviation|Mean
1241498|NCT00570505|Post-Hoc|Change in Obesity Related Comorbid Conditions (5 Years)|Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved 5 years post LAP-BAND implantation. Diabetes resolution was defined as HbA1c ≤ 6% and no diabetes medication usage. Dyslipidemia resolution was defined as HDL ≥ 60 mg/dL, LDL < 100 mg/dL, triglycerides < 150 mg/dL, and total cholesterol < 200 mg/dL. Hypertension resolution was defined as systolic blood pressure < 140 mm Hg.|5 years|Subjects who had the specific comorbid condition at screening (Type 2 Diabetes n=5, Dyslipidemia n=45, Hypertension n=49)|||percentage of subjects|||Number
1241499|NCT00570505|Post-Hoc|Subject Percent Excess Weight Loss (5 Years)|The mean percent excess weight loss (%EWL) for subjects at month 60. Percent EWL = (weight loss divided by excess weight)*100.|5 years|Intent-to-treat (ITT)|||percentage of excess weight loss||Standard Deviation|Mean
1241500|NCT00570505|Post-Hoc|Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation|The percent of subjects who attained clinically successful weight loss (ie, ≥ 30% Excess Weight Loss) at year 5 post LAP-BAND implantation. Percent EWL =(weight loss divided by excess weight)*100. Excess Weight was defined as Baseline Weight - Ideal Weight, where Ideal Weight was a BMI of 25 kg/m2.|5 years|Intent-to-treat (ITT)|||percentage of subjects||95% Confidence Interval|Number
1241501|NCT00570505|Secondary|Change in Quality of Life|Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported.|12 months|Intent-to-treat (ITT)|||units on a scale||Standard Deviation|Mean
1241502|NCT00570505|Secondary|Change in Comorbid Conditions Related to Obesity|"Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as none on a severity scale of none, mild, moderate, or severe) 12 months after implantation."|12 months|Subjects who had the specific comorbid condition at baseline (Diabetes n = 6, Dyslipidemia n = 29, Hypertension n = 27)|||percentage of subjects|||Number
1241503|NCT00570505|Secondary|Percent Weight Loss|Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2.|Baseline through 12 months|Intent-to-treat (ITT)|||percentage of weight loss||Standard Deviation|Mean
1241504|NCT00570505|Primary|Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation|The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100.|One year|Intent-to-treat (ITT)|||percentage of subjects|||Number
1241505|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color|Participants were assessed for their urine appearance, which was categorized as clear (normal), cloudy (presence of crystals, blood cells, or bacteria), of turbid. Also, participants were categorized by the color of urine: straw, yellow (normal urine), and dark yellow (DY) (which may be the result of bile in the urine).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||participants|||Number
1241506|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)|Occult blood (OB) is blood that cannot be seen without a microscope. Normal urine does not contain any red blood cells. Leukocyte esterase is an enzyme and is not found in normal urine. In the dipstick (qualitative) test, the level of OB and leukocyte esterase in urine samples was recorded as negative (Neg), small, moderate, large, trace, 1+ (slightly positive), 2+ (positive), and 3+ (high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of OB and urine leukocyte esterase.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||participants|||Number
1241533|NCT00570141|Primary|Percent Wounds Closed|"Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.~The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU)."|baseline and 12 weeks|Analysis was Per Protocol|||Percent of Wounds Closed|||Number
1241507|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins|Urine glucose, urine ketones, and urine proteins were measured in participants using a dipstick (qualitative) test at the indicated time points. In this dipstick test, the level of glucose, ketones, and protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of glucose, ketones, and proteins in the urine.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||participants|||Number
1241508|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite|Bilirubin is a normal body by-product (bile), and nitrite is a by-product of bacterial growth. Participants were categorized as Negative (Neg.) or Positive (Pos.) based on the absence or presence, respectively, of urine bilirubin (UB) and urine nitrate.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||participants|||Number
1241509|NCT00570492|Secondary|Mean Values for Urine Specific Gravity|Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||ratio||Standard Deviation|Mean
1241510|NCT00570492|Secondary|Mean Values for Urine pH|Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||scores on a scale||Standard Deviation|Mean
1241511|NCT00570492|Secondary|Mean Hematology Values for Red Blood Cells (RBCs)|RBCs was assessed in participants at the indicated time points.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Trillion (10^12) cells (Ti)/L||Standard Deviation|Mean
1241512|NCT00570492|Secondary|Mean Values for Hematocrit|Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Percentage of BV occupied by RBCs||Standard Deviation|Mean
1241513|NCT00570492|Secondary|Mean Values for Hemoglobin|Hemoglobin was assessed in participants at the indicated time points.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||g/L||Standard Deviation|Mean
1241514|NCT00570492|Secondary|Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts|Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Giga (10^9) cells (Gi)/L||Standard Deviation|Mean
1241515|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Millimoles (mmol)/L||Standard Deviation|Mean
1241516|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Micromoles (µmol)/L||Standard Deviation|Mean
1241517|NCT00570492|Secondary|Mean Values for the Laboratory Parameters if Albumin and Total Protein|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1241518|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||International Units per liter (IU/L)||Standard Deviation|Mean
1243769|NCT00554099|Secondary|Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12||12 Weeks|ITT Population|||Percentage of Participants|||Number
1241519|NCT00570492|Secondary|Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results|NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (>=1 nostril).|Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons.|||participants|||Number
1241520|NCT00570492|Secondary|Mean 24-hour Urinary Free Cortisol Excretion|Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval.|Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)|Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value <1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis.|||Micrograms per 24 hours (mcg/24 hours)||Standard Deviation|Mean
1241521|NCT00570492|Primary|Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period|Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.|Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)|Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period|||Centimeters per year (cm/year)||Standard Error|Least Squares Mean
1241522|NCT00570401|Primary|Determine the Overall Objective Response|To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST.|2 years||||participants|||Number
1241523|NCT00570362|Primary|Total Glutathione Levels|Subjects were instructed to fast from midnight to 8 AM on the morning of the test. All blood samples were obtained by a qualified registered nurse in the morning, between 8 and 10 AM.|Once in the morning.||||nmol||Standard Deviation|Mean
1241524|NCT00570349|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1)|Decrease in forced expiratory volume in 1 second was measured through spirometer. Spirometer measures the volume of air inspired and expired by the lungs.|Baseline and 48 hours||||Liters||Standard Deviation|Mean
1241525|NCT00570349|Primary|Change in Oxygen Saturation|"Safety and tolerability of drug assessed by decreased oxygen saturation was measured through pulse oximeter, which measure the amount of oxygen in the blood.~Normal range percentage is 95 - 100%"|Baseline and 48 hours||||Percent of oxygen saturation||Standard Deviation|Mean
1241526|NCT00570349|Secondary|Assess the Difference in Sputum Bacterial Density Before and After NO Inhalation. Assess the Difference in Lower Airway Inflammatory Measures Before and After NO Inhalation||44 hours|||||||
1241527|NCT00570349|Primary|Safety and Tolerability of Drug, Assessed by Change in Methemoglobin Levels|Methemoglobin level assessments were measured through blood draws - hematology. This test measures the amount of methemoglobin (a type of hemoglobin that is unable to transport oxygen to tissues) in blood. Normal methemoglobin percentage range 1% - 2%.|Baseline and 48 hours||||Percent of Methemoglobin Level||Standard Deviation|Mean
1241528|NCT00570310|Secondary|'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study|Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)|6 Weeks|Primary Responders: ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.|||Days||Full Range|Least Squares Mean
1241529|NCT00570310|Primary|Daily Evening Patient Reported Pain Intensity Scores|Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)|Baseline and 6 Weeks|Patients who had a ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.|||Units on a Scale||Full Range|Least Squares Mean
1241530|NCT00570232|Secondary|Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.|Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy|12 - 24 months||||percentage of participants|||Number
1241531|NCT00570232|Primary|Percentage of Participants With Disease Free Status at 12 Months and 24 Months|Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)|12 - 24 months||||percentage of participants|||Number
1241532|NCT00570232|Primary|Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment|Number of participants who had the most frequently observed undesirable effects after exposure to study drug|12 - 24 months||||participants|||Number
1243787|NCT00553735|Primary|Corneal Staining Score||18 months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
1241534|NCT00570141|Primary|Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.|"Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.~The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment.~Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)"|Baseline and weekly up to 12 weeks|Analysis was Per Protocol|||cm2||Standard Deviation|Mean
1241535|NCT00570089|Secondary|Seattle Angina Questionnaire (SAQ)|"Questionnaires will be completed (SAQ - Seattle Angina Questionnaire) at the end of each treatment period.~The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.~Each final SAQ domain ranges from 0-100, where higher is a better outcome score. Subscales are not combined. Median, SD and range are calculated for each domain."|4 weeks and 10 weeks||||units on a scale||Full Range|Median
1241536|NCT00570089|Primary|Cardiac Magnetic Resonance (CMRs)|Cardiac Magnetic Resonance (CMRs) (CMR 1 and CMR 2) end of the 4th week of treatment 1 and treatment 2 respectively, 4 hours after the morning dose of study drug was performed to measure myocardial perfusion defect in percentage.|4 weeks and 10 weeks||||Percentage of ischemic myocardium||Full Range|Median
1241537|NCT00570063|Other Pre-specified|Steady State Average Concentration of PF-02545920 Over the Dosing Interval (Css,Avg)||Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21|Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient PK sampling to support development of a model to calculate the PK parameters.||||||
1241538|NCT00570063|Other Pre-specified|Area Under the Concentration Time Curve (AUC) of PF-02545920|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21|Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient PK sampling to support development of a model to calculate the PK parameters.||||||
1241539|NCT00570063|Other Pre-specified|Oral Clearance (CL/F) of PF-02545920|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21|Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient pharmacokinetic (PK) sampling to support development of a model to calculate the PK parameters.||||||
1241540|NCT00570063|Other Pre-specified|Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21|SSS is a 7-point Likert scale which facilitates standardized observation of alertness and rates sleepiness, where 1= alert/wide awake, 2= able to concentrate, 3= not at full alertness, 4= not at peak and let down, 5= beginning to lose interest in remaining awake, 6= sleepiness, 7= sleep onset soon; lost struggle to remain awake. Score ranging from 1 to 7, where higher score indicates more sleepiness.|Baseline (Day 1), Day 4, 7, 14, 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1241541|NCT00570063|Other Pre-specified|Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21|ESRS-A is an instrument used to assess extrapyramidal symptoms (including tremor and dystonic reactions). It assesses 4 items: Parkinsonism, dystonia, dyskinesia, and akathisia. Each item is scored on a 5-point severity scale ranging from 0 to 4, with higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1241542|NCT00570063|Other Pre-specified|Change From Baseline in Abdominal Girth at Day 21||Baseline (Day 1), Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||centimeter||Standard Deviation|Mean
1241543|NCT00570063|Other Pre-specified|Change From Baseline in Body Weight at Day 21||Baseline (Day 1), Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||kilogram||Standard Deviation|Mean
1241544|NCT00570063|Other Pre-specified|Number of Participants With Abnormal Fasting Insulin Level|Fasting glucose level below 6 micro international unit per milliliter (mcIU/mL) or above 27 mcIU/mL were considered as abnormal. Number of participants with abnormal values of fasting insulin level were reported.|Baseline (Day 1) up to Day 21|Safety analysis set included all participants who received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1241545|NCT00570063|Other Pre-specified|Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level|Number of participants with abnormal values (>1.3* ULN) of HbA1c level were reported.|Baseline (Day 1) up to Day 21|Safety analysis set included all participants who received at least 1 dose of study medication. Here, ‘N’ signifies those participants who were evaluable for this measure.|||participants|||Number
1241546|NCT00570063|Other Pre-specified|Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level|Number of participants with abnormal values of HDL level <0.8* LLN and LDL level >1.2*ULN were reported.|Baseline up to Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1241547|NCT00570063|Other Pre-specified|Number of Participants With Abnormal Prolactin Level|Number of participants with abnormal values (>1.1* ULN) of prolactin level were reported.|Baseline (Day 1) up to Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1241657|NCT00569270|Primary|Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)|Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients.|30 days|Includes groups randomized to receive placebo first and Tiotropium first.|||Liters||Standard Deviation|Mean
1241548|NCT00570063|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell (RBC) count: <0.8*lower limit of normal (LLN), platelet: <0.5*LLN or >1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil: <0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte: >1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase: > 3.0*ULN, total protein, albumin: <0.8*LLN or>1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; cholesterol (HDL <0.8*LLN, LDL >1.2*ULN); sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; prolactin >1.1*ULN; glucose <0.6*LLN or >1.5*ULN, glycosylated hemoglobin >1.3*ULN, creatine kinase >2.0*ULN; urine (pH <4.5 or >8, glucose, ketone, protein, blood/Hgb >=1, RBC, WBC >=6).|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1241549|NCT00570063|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern|Criteria for ECG values for potential clinical concern: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >100 msec, and >=50 percent increase when baseline <=100 msec; QTcB interval (corrected QT interval using Bazett's formula) >=500 msec.|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1241550|NCT00570063|Other Pre-specified|Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities|Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal and neurological systems. Clinical significance was based on the investigator’s discretion.|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1241551|NCT00570063|Other Pre-specified|Number of Participants With Vital Signs of Potential Clinical Concern|Criteria for vital signs of potential clinical concern: pulse rate (supine/sitting position) less than (<) 40 or greater than (>) 120 beats per minute (bpm), pulse rate in standing position <40 or >140 bpm; systolic blood pressure (SBP) <90 millimeters of mercury (mm Hg) and greater than or equal to (>=) 30 mm Hg change (increase, decrease) from baseline in same posture; diastolic blood pressure (DBP) <50 mm Hg and >=20 mm Hg change (increase, decrease) from baseline in same posture.|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1241552|NCT00570063|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1241553|NCT00570063|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21|GAF is a single clinician-rated item to measure the severity of illness-related impairment in psychological, social and occupational functioning. It is a 100 point rating scale, score range: 0= worst functioning to 99= superior functioning, where higher scores indicates better functioning.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241554|NCT00570063|Secondary|Change From Baseline in Nurses’ Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21|NOSIE is an inpatient treatment staff-administered questionnaire. It consists of 30 items: 26 items divided into 6 subscales and 4 individual items. Each item is rated on a 5-point scale (0= never to 4= always), to assess functional ability of participants. 6 subscales: irritability (sum of 5 items: score range 0 to 20), manifest psychosis (sum of 4 items: score range 0 to 16), personal neatness (sum of 4 items: score range 0 to 16), retardation (sum of 3 items: score range 0 to 12), social competence (sum of 5 items: score range 0 to 20) and social interest (sum of 5 items: score range 0 to 20) and 4 individual items: cried (score range 0 to 4), refused to speak (score range 0 to 4), said felt blue or depressed (score range 0 to 4) and said he/she was no good (score range 0 to 4). For each of the 6 subscales and 4 individual items: higher scores indicates irregular functional ability.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241555|NCT00570063|Secondary|Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21|CGI-improvement is a 7-point clinician-rated scale for assessing the global improvement of schizophrenia ranging from 1 (very much improved) to 7 (very much worse). Higher score indicating less improvement.|Baseline (Day 4), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241556|NCT00570063|Secondary|Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21|CGI-S is a 7-point clinician-rated scale for assessing the global severity of schizophrenia. Score range: 1 (normal - not ill at all) to 7 (most extreme illness). Higher score indicating greater degree of illness.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241592|NCT00569803|Secondary|Number of Participants With Vital Sign Abnormalities|Vital signs (body temperature, respiratory rate, seated blood pressure, and heart rate) were recorded at screening. All significant findings were evaluated by the investigator, and all abnormalities were listed.|1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116|All treated participants|||participants|||Number
1241557|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score|BPRS is a clinician-rated instrument for assessing conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content associated with schizophrenia. The scale consists of 18 items. Each item is rated on a scale from 0 (symptom not present) to 6 (symptoms extremely severe). BPRS core psychosis total score is the sum of 18 items and ranges from 0 to 108; where higher score indicates greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241558|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS anxiety/depression Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS anxiety/depression Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241559|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS hostility/excitement Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS hostility/excitement Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241560|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS disorganized thought Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS disorganized thought Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241561|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS negative Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241562|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS positive Marder factor score consists of 8 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive Marder factor score is the sum of 8 items and ranges from 8 to 56; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241563|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score|PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS general psychopathology subscale score assesses general psychopathology symptoms associated with schizophrenia as somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. It consists of 16 items and each item is rated on a scale from 1 (symptoms absent) to 7 (extreme psychopathology). PANSS general psychopathology subscale score is the sum of 16 items and ranges from 16 to 112; where higher scores indicates greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241564|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score|PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS negative subscale assesses negative symptoms associated with schizophrenia as blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative subscale score is the sum of 7 items and ranges from 7 to 49, where higher score indicates greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241626|NCT00569582|Primary|Decrease in Diastolic Blood Pressure.|Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.|Baseline to Week 24||||participants|||Number
1241565|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score|PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS positive subscale assesses the positive symptoms associated with schizophrenia as delusions, conceptual disorganization, and hallucinatory behavior. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive subscale is the sum of 7 items and ranges from 7 to 49; where higher score indicates greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241566|NCT00570063|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score|PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). PANSS total score is the sum of the 30 items and ranges from 30 to 210; where higher score indicates greater severity of symptoms.|Baseline (Day 1), Day 21|Pharmacodynamic data (PD) analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
1241567|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns|The percent of all household contacts of newborns who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby|Pregnancy period through 6 to 8 weeks postpartum||||Percentage of All Household Contacts|||Number
1241568|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for New Fathers of Newborns|The percent of new fathers who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby|Pregnancy period through 6 to 8 weeks postpartum||||Percentage of Fathers of Newborns|||Number
1241569|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for New Mothers of Newborns|The percent of new mothers delivering at the hospital who reported receiving an influenza vaccine during their pregnancy, in the hospital after delivery, or during the 6 to 8 week postpartum period|Pregnancy period through 6 to 8 weeks postpartum||||Percentage of Participants|||Number
1241570|NCT00569946|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria (CTCAE) for Adverse Events Version 3.0 Grade 3 or higher , serious adverse events, or adverse events resulted in discontinuation.|Up to 1709 days of treatment plus 28-days follow-up|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
1241571|NCT00569946|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
1241572|NCT00569946|Secondary|Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
1241573|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
1241574|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
1241575|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
1241576|NCT00569946|Secondary|Number of Participants Analyzed for Population Pharmacokinetics of AG-013736|Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.|Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose|No population pharmacokinetic analysis results are available just for the current study.||||||
1241577|NCT00569946|Secondary|Overall Survival (OS)|"OS was defined as the time from date of first dose of AG-013736 to date of death due to any cause.~Subjects in whom death is not reported will have their event time censored on the last date the subject is known to be alive."|Up to 2002 days (maximum duration of treatment plus follow-up observation)|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
1241588|NCT00569803|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (*10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx).~Leukocytes (*10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre-Rx>ULN, use >1.15*Pre-Rx or <LLN) Neutrophils+Bands (*10^3 c/uL): <=1.500. Lymphocytes (*10^3 c/uL): <0.750 or >7.500. Monocytes (*10^3 c/uL): >2.000. Basophils (*10^3 c/uL): >0.400. Eosinophils (*10^3 c/uL): >0.750."|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants|||participants|||Number
1241578|NCT00569946|Secondary|Duration of Response|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication. DR was calculated for the subgroup of participants with a confirmed objective tumor response. n=number of participants assessed as CR or PR.|||months||95% Confidence Interval|Median
1241579|NCT00569946|Secondary|Time to Tumor Progression (TTP)|Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Up to 1709 days of treatment|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
1241580|NCT00569946|Secondary|Progression-Free Survival (PFS)|Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Up to 1709 days of treatment|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
1241581|NCT00569946|Primary|Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.|Up to 765 days of treatment at the data cut-off date|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1241582|NCT00569946|Primary|Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.|Up to 765 days of treatment at the data cut-off date|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1241583|NCT00569868|Primary|Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.|"Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment.~Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute’s guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle.~Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response."|60 days|no analysis done, descriptive information on the magnitude, direction, and variability of changes in coagulation factors and platelet function in refractory/relapsing multiple myeloma patients during VELCADE treatment was collected|||participants|||Number
1241584|NCT00569855|Primary|Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively|Number of subjects who required Norepinephrine >0.1mcq/kg/min|72 hours postoperatively|No. of subjects consented = 832; 785 subjects received study drug|||participants|||Number
1241585|NCT00569803|Secondary|Number of Participants With Positive Immunogenicity to Belatacept|The number of participants with positive immunogenicity to Belatacept was reported for each arm. Positive immunogenicity was defined as the presence of a positive antibody response generated against Belatacept.|Days 1, 14, 28, 42, 56, 86, 116|All participants treated with Belatacept|||participants|||Number
1241586|NCT00569803|Secondary|Number of Participants With Marked Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Glucose (mg/dL): <0.8*LLN, >1.5*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN).~Protein (grams per deciliter: g/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).~Albumin (g/dL): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mg.dL): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)"|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants|||participants|||Number
1241587|NCT00569803|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).~Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).~Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (mg/dL): >1.33*Pre-Rx. Sodium (milliequivalents per Liter: mEq/L): <0.95*LLN, >1.05*ULN (if Pre-Rx<LLN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN).~Potassium(mEq/L), Chloride (mEq/L), Calcium(mg/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).~Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN)."|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants|||participants|||Number
1241593|NCT00569803|Secondary|Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption|"AUC(0-T) and AUC(INF) for Belatacept were derived from serum concentration versus time data to assess the effect of number of injection sites on the subcutaneous absorption of Belatacept. All treatments were dose-normalized to 50mg. Adjusted geometric means reported in microgram hours per milliliter (ug*h/mL).~AUC(0-T) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration.~AUC(INF) = Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time."|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||ug*h/mL||90% Confidence Interval|Geometric Mean
1241594|NCT00569803|Primary|Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept|Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with SC Belatacept|||Liters||Geometric Coefficient of Variation|Geometric Mean
1241595|NCT00569803|Primary|Volume of Distribution at Steady State (VSS) for IV Belatacept|Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with IV Belatacept|||Liters||Standard Deviation|Mean
1241596|NCT00569803|Primary|Total Body Clearance (CLT) of IV Belatacept|Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with IV Belatacept|||mL/h||Geometric Coefficient of Variation|Geometric Mean
1241597|NCT00569803|Primary|Apparent Total Body Clearance (CLT/F) of SC Belatacept|Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with SC Belatacept|||mL/h||Geometric Coefficient of Variation|Geometric Mean
1241598|NCT00569803|Primary|Serum Half-life (T-HALF) of Belatacept|Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||hours||Standard Deviation|Mean
1241599|NCT00569803|Primary|Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept|Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL)|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||ug*h/mL||90% Confidence Interval|Geometric Mean
1241600|NCT00569803|Primary|Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept|Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||ug*h/mL||90% Confidence Interval|Geometric Mean
1241601|NCT00569803|Primary|Time of Maximum Observed Serum Concentration (Tmax) of Belatacept|Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||hours||Full Range|Median
1241602|NCT00569803|Primary|Maximum Observed Serum Concentration (Cmax) of Belatacept|Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1241603|NCT00569777|Primary|Visual Acuity Assessment|Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.|at 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Eyes|Participants||Number
1241604|NCT00569777|Primary|Dilated Ophthalmoscopy - Vitreous, Change From Baseline|Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects / 4 eyes.|||Units on a scale|Participants|Standard Deviation|Mean
1241605|NCT00569777|Primary|Dilated Ophthalmoscopy - Fundus, Change From Baseline|Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects/4 eyes.|||Units on a scale|Participants|Standard Deviation|Mean
1241606|NCT00569777|Primary|Intraocular Pressure, Change From Baseline||baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||mm of mercury|Participants|Standard Deviation|Mean
1241607|NCT00569777|Primary|Corneal Staining - Central, Change From Baseline|Assessment of changes to the surface of the cornea, central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241608|NCT00569777|Primary|Corneal Staining - Superior, Change From Baseline|Assessment of changes to the surface of the cornea, upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241609|NCT00569777|Primary|Corneal Staining - Inferior, Change From Baseline|Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241610|NCT00569777|Primary|Corneal Staining - Temporal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the outer edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241611|NCT00569777|Primary|Corneal Staining - Nasal, Change From Baseline|Assessment of changes to the surface of cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241612|NCT00569777|Primary|Cells in Anterior Chamber, Change From Baseline|Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241613|NCT00569777|Primary|Flare in Anterior Chamber, Change From Baseline|Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241614|NCT00569777|Primary|Lens Pathology, Change From Baseline|Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241615|NCT00569777|Primary|Corneal Endothelial, Change From Baseline|Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Analysis includes subjects that completed the 12 week visit per protocol.|||Units on a scale|Participants|Standard Deviation|Mean
1241616|NCT00569777|Primary|Corneal Erosion, Change From Baseline|Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241617|NCT00569777|Primary|Corneal Edema, Change From Baseline|Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241618|NCT00569777|Primary|Conjunctival Chemosis, Change From Baseline|Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241619|NCT00569777|Primary|Conjunctival Redness, Change From Baseline|Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241620|NCT00569777|Primary|Lid and Lid Margin Swelling, Change From Baseline|Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241621|NCT00569777|Primary|Lid and Lid Margin Erythema, Change From Baseline|Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1241622|NCT00569673|Secondary|Duration of Progression-free Survival and Overall Survival||up to 5 years|||||||
1241623|NCT00569673|Primary|Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Prior to each cycle and 30 days after the last cycle (average of 5 months)|Eligible and treated patients|||Participants|||Count of Participants
1241624|NCT00569673|Primary|Objective Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6"|every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)|Total number eligible and evaluable|||participants|||Number
1241625|NCT00569660|Primary|Number of Participants With Objective Clinical Response|Objective Clinical Response includes Participants with Complete Response, Partial Response or Hematologic Improvement and No Response. Bone marrow aspiration and biopsy with cytogenetics every 2 to 4 courses.|Every 2 courses of 4 week therapy = each 8 weeks|The statistical analysis for response rates determined on the intent-to-treat (ITT) populations. This is defined as all enrolled patients who received at least one dose of study medication.|||Participants|||Number
1241627|NCT00569582|Primary|Improvement in Diabetes and/or Glucose Intolerance.|Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.|Baseline to Week 24|Patients with at least 30 days of dosing.|||participants|||Number
1241628|NCT00569530|Secondary|Alive Without BPD at 36 Weeks Post Menstrual Age|Alive without need for oxygen at 36 weeks post menstrual age.|36 Weeks Post Menstrual Age||||Number of infants|||Number
1241629|NCT00569530|Primary|SP-B Content|SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.|One day after dose|24 of 43 in the Treatment Group and 18 of 42 in the Sham group had samples analyzed. SpB content recorded as a percentage of Total Phospholipids.|||Total surfactant protein (% of PL)||Full Range|Mean
1241630|NCT00569374|Secondary|Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.|The Amphetamine Withdrawal Questionaire was given at intake and 3 times weekly during the first 3 weeks of the study. This time span was chosen due to the tendency of methamphetamine withdrawal to enter an acute phase in the first week after last use with a subsequent subacute phase following for the next two weeks(McGregor et al, 2005). This questionaire is comprised of 10 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score is 0 and the maximum score is 40.|Thrice weekly for the first three weeks|The data reported was obtained by computing the overall mean numerical score on the Amphetamine Withdrawal Questionaire for each participant, then using these to compute the overall mean. The scale consists of 13 items ranging from 0 (none) to 4 (worst). The total score ranges from 0 (least) to 52 (worst).|||units on a scale||Standard Deviation|Mean
1241631|NCT00569374|Primary|Depression as Measured by the Hamilton Depression Scale|Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean score on the Hamilton Depression Scale for each participant, then using these to compute the overall mean. It is a 22 item scale of which 13 items have a score of 0 (none) to 4 (worst) and 9 have a score of 0 (none) to 2 (worst). The total score ranges from 0 (least) to 70 (worst).|||units on a scale||Standard Deviation|Mean
1241632|NCT00569374|Primary|Anxiety as Measured by the Hamilton Anxiety Scale|Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean score on the Hamilton Anxiety Scale for each participant, then using these to compute the overall mean. The scale is a 14 item instrument with each item scoring a potential range of 0 (none) to 4 (worst). The potential total scores range form 0 (least) to 56 (worst).|||units on a scale||Standard Deviation|Mean
1241633|NCT00569374|Primary|"Modafinil Side Effects Checklist"|"Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from not at all (0) to very much (4). The score was determined by units on a scale."|Weekly for 7 weeks|The data reported was obtainined by computing the overall mean numberical score on the Modafinil Side Effects Checklist for each participant, then using these to compute the overall mean. The checklist is a 10 item scale with each item scoring between 0 (none) to 4 (worst). The potential scores range from 0 (least) to 40 (worst).|||units on a scale||Standard Deviation|Mean
1241634|NCT00569374|Primary|Diastolic Blood Pressure|Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean diastolic blood pressure for each participant, then using these to compute the overall mean.|||mmHg||Standard Deviation|Mean
1241635|NCT00569374|Primary|Systolic Blood Pressure|Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean systolic blood pressure for each participant, then using these to compute the overall mean.|||mmHg||Standard Deviation|Mean
1241636|NCT00569374|Primary|Heart Rate|Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean heart rate for each participant, then using these to compute the overall mean.|||beats per minute||Standard Deviation|Mean
1241637|NCT00569309|Secondary|Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials||Up to 3 years|Data was not collect and analyzed for reporting purposes||||||
1241638|NCT00569309|Secondary|Quality of Life, Including Fatigue|Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.|Up to 3 years||||units on a scale||Standard Deviation|Mean
1241639|NCT00569309|Secondary|Quality of Life, Including Brief Pain Inventory|The Brief Pain Inventory – Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.|Up to 3 years|Not all patients data was available due to incomplete surveys|||units on a scale||Standard Deviation|Mean
1241640|NCT00569309|Secondary|Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes||Up to 3 years|Quality of Life surveys were not completed||||||
1241641|NCT00569309|Secondary|Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFβ and Interleukin-10 (IL-10)||Up to 3 years|Inadequate material collected to perform these assays||||||
1241642|NCT00569309|Primary|Number of Participants Experiencing Immune Reconstitution|Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV & EBV tetramer responses after autologous transplant for myeloma|Up to 2 years||||Participants|||Count of Participants
1241643|NCT00569270|Secondary|Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium|Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema|baseline to trough tiotropium|High resolution, thin-section scans of the lung were obtained in a subset of 19 patients.|||percentage of lung tissue||Standard Deviation|Mean
1241644|NCT00569270|Primary|TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo|Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention & 2 hrs. after after 30 days of treatment with either placebo or tiotropium|one hour before intervention & 2 hrs. after after 30 days|lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
1241645|NCT00569270|Primary|IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline|IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo|baseline and 30 days (+2h) post dose|Inspiratory capacity (IC) (mean +/- SD) from baseline and after 30 days of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
1241646|NCT00569270|Primary|Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo|Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|30 days|Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|||liters||Standard Deviation|Mean
1241647|NCT00569270|Primary|Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo|Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage|30 days|Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage|||percentage of FRC/TLC||Standard Deviation|Mean
1241648|NCT00569270|Primary|Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo|Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters|30 days|Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters|||liters||Standard Deviation|Mean
1241649|NCT00569270|Primary|Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo|Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|30 days|Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|||liters||Standard Deviation|Mean
1241650|NCT00569270|Primary|Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo|Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)|30 days|Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)|||liters||Standard Deviation|Mean
1241651|NCT00569270|Primary|Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo|Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters)|30 days|Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|||liters||Standard Deviation|Mean
1241652|NCT00569270|Primary|Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters|30 days|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
1241653|NCT00569270|Primary|Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo|Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage|30 days|Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage|||percentage of FRC/TLC||Standard Deviation|Mean
1241654|NCT00569270|Primary|Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo|Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters|30 days|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
1241655|NCT00569270|Secondary|IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema|Correlation between change in inspiratory capacity (L) post metronome paced hyperventilation induced dynamic hyperinflation and extent of lung ct scored emphysema|baseline to 30 days|Analysis was carried out per protocol|||percentage of lung tissue||Standard Deviation|Mean
1241656|NCT00569270|Primary|Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo|Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters|30 days|Peak FVC after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
1243803|NCT00553644|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry until death. The median OS with 95% CI was estimated using the Kaplan-Meier method..|Assessed up to 6 years||||years||95% Confidence Interval|Median
1241658|NCT00569270|Secondary|Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium|Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to FEV 1; correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measures include increase in FEV1 from baseline to peak tiotropium|baseline to 30 days|High-resolution, thin-section scans of the lung were obtained from a subset of 19 patients.|||percentage of lung tissue||Standard Deviation|Mean
1241659|NCT00569270|Primary|Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-|Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second|30 days|Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second|||liters||Standard Deviation|Mean
1241660|NCT00569231|Other Pre-specified|Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide|Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide.|Initial visit to completion of protocol, which is up to 30 weeks|The interferon-γ enzyme-linked immunospot assay was performed on available samples from participants who completed the study.|||Participants|||Number
1241661|NCT00569231|Secondary|Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart|When the participant completed the protocol, clinical resolution of 2nd anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.|Initial visit to completion of protocol, which is up to 30 weeks|The participants with 2nd anatomically distant, non-injected wart were analyzed.|||Participants|||Number
1241662|NCT00569231|Secondary|Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart|When the participant completed the protocol, clinical resolution of 1st anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.|Initial visit to completion of protocol, which is up to 30 weeks|Participants with 1st anatomically distant, non-injected wart were analyzed.|||Participants|||Number
1241663|NCT00569231|Primary|Number of Participants With Clinical Resolution of Injected Wart|When the participant completed the protocol, clinical resolution of the injected wart was determined by the overall percentage of resolution from the initial visit. Participants were classified as 'complete responders' if they had complete resolution of the injected wart, 'partial responders' if the injected wart regressed between 25% and 99%, and 'non-responders' if they had not achieved at least 25% regression of the injected wart.|Initial visit to completion of protocol, which is up to 30 weeks|The participants were analyzed if they completed the protocol by achieving complete resolution of the treated wart, receiving the maximum of 10 treatments, or by having less than 25% resolution of the treated wart after 5 treatments.|||Participants|||Number
1241664|NCT00569192|Secondary|Change From Baseline in Nighttime Individual Symptom Scores|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.|||units on a scale||Standard Deviation|Mean
1241665|NCT00569192|Secondary|Change From Baseline in Daytime Individual Symptom Scores|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.|||units on a scale||Standard Deviation|Mean
1241666|NCT00569192|Secondary|Change From Baseline in PEF|The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).|baseline, week 12|The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.|||L/min||Standard Deviation|Mean
1241667|NCT00569192|Primary|Change From Baseline in Nighttime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.|||units on a scale||Standard Deviation|Mean
1241668|NCT00569192|Secondary|Change From Baseline in FEV1% Predicted|The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).|baseline, week 12|The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.|||percentage of predicted FEV1||Standard Deviation|Mean
1241669|NCT00569192|Primary|Change From Baseline in Daytime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.|||units on a scale||Standard Deviation|Mean
1241670|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9|Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the Symptom Experience Diary item scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||Correlation coefficient|||Number
1241671|NCT00569166|Secondary|Change From Baseline to Week 9 for Symptom Distress Diary|Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||units on a scale||Standard Deviation|Mean
1241672|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the BFI fatigue items scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||Correlation coefficient|||Number
1241673|NCT00569166|Secondary|Change From Baseline to Week 9 for BFI Fatigue Scores|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||units on a scale||Standard Deviation|Mean
1241674|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the POMS scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||Correlation coefficient|||Number
1241675|NCT00569166|Secondary|Change From Baseline to Week 9 for POMS Total Score and Subscales|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||units on a scale||Standard Deviation|Mean
1241676|NCT00569166|Secondary|Change From Baseline to Week 9 on Blood Pressure Measurement|Participants were taught home monitoring of blood pressure and provided with the sphygmomanometer. The measurements data were recorded on the Blood Pressure Measurement log. Change from baseline to week 9 was calculated by subtracting the baseline measurement from the measurement at week 9.|Baseline and Week 9|Includes all participants who had both baseline and week 9 blood pressure measurements.|||mmHg||Full Range|Median
1241686|NCT00568958|Primary|Percent Days Abstinent From Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.|8 Weeks||||% days abstinent||Standard Deviation|Mean
1241677|NCT00569166|Secondary|Change From Baseline to Week 9 for PSQI Global Score|The Pittsburgh Sleep Quality Index (PSQI) has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The global score is translated into 0-100 scale with high values representing best quality of life (QOL). The habitual sleep efficiency component and global score was estimated using the worst-case scenarios for the values that were provided for PSQI question 4. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||units on a scale||Full Range|Median
1241678|NCT00569166|Primary|The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9|Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.|Week 1 and Week 9||||units on a scale||Standard Deviation|Mean
1241679|NCT00569127|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary. Eleven patients did not start protocol treatment due to: patient refusal (6), financial reasons (3), and worsening condition/progression (2). None were assessable for adverse events and thus are not included in this analysis.|||Participants|||Number
1241680|NCT00569127|Secondary|Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is disappearance of all measurable and non-measurable disease, and no new lesions; Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|All eligible patients with measurable disease will be included in this analysis according to the randomized treatment assignment.|||participants|||Number
1241681|NCT00569127|Secondary|Local Progression-Free Survival (Investigator Assessed)|From date of randomization (which is the date of registration) to date of first documentation of progression [per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as defined in Section 10.2d] or symptomatic deterioration (as defined in Section 10.2e), or death due to any cause. Patients last known not to have progressed are censored at date of last contact. Progression (Section 10.2d) includes one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over smallest sum observed using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of new lesion/site; or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration (Section 10.2e) is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.|||months||95% Confidence Interval|Median
1241682|NCT00569127|Secondary|Time to Treatment Failure|From date of randomization (which is the date of registration) to date of first observation of progressive disease (as defined in Section 10.2d), death due to any cause, symptomatic deterioration (as defined in Section 10.2e), or discontinuation of treatment. This has been calculated using Central-Review based progression events. Patients last known not to have failed treatment are censored at date last known not to have failed. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not failed treatment prior to that time.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.|||months||95% Confidence Interval|Median
1241683|NCT00569127|Primary|Central Review-based Progression-Free Survival|From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.|||months||95% Confidence Interval|Median
1241684|NCT00569127|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 7 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.|||months||95% Confidence Interval|Median
1241685|NCT00569010|Primary|Number of Participants With Complete Remission|Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery) according to International Working Group (IWG) criteria.|6 weeks|Analysis was per protocol.|||participants|||Number
1241687|NCT00568958|Primary|Percent Days Abstinent From Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks.|Baseline||||% days abstinent||Standard Deviation|Mean
1241688|NCT00568958|Secondary|Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher|"Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.~BAL (Blood Alcohol Level) was estimated using data from the daily diaries based on the number of drinks consumed, the duration of drinking, and total body water (based on gender, age, height and weight) using Curtin’s formula."|8 weeks||||percentage of days||Standard Deviation|Mean
1241689|NCT00568958|Secondary|Number of Drinks Per Drinking Day|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.|8 Weeks||||drinks per drinking day||Standard Deviation|Mean
1241690|NCT00568958|Primary|Frequency of Heavy Episodic Drinking|"Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.~Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females over an eight week period. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor)."|eight weeks||||percentage of heavy drinking days||Standard Deviation|Mean
1241691|NCT00568958|Secondary|Number of Drinks Per Drinking Day|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks.|Baseline||||drinks per drinking day||Standard Deviation|Mean
1241692|NCT00568958|Primary|Frequency of Heavy Episodic Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor). Baseline measures captured the prior 4 weeks.|Baseline||||percentage of heavy drinking days||Standard Deviation|Mean
1241693|NCT00568854|Primary|Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination|Blood was sampled at times 0, 2, 4, 6, 8, 12, 16, and 20 weeks post BCG vaccination and Interferon gamma production was measured as change from pre-vaccination baseline. Timeline of peak IFn-g response was measured for both study groups.|5 months||||weeks when peak response was observed||Standard Deviation|Mean
1241694|NCT00568854|Primary|Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test|Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.|5 months||||mm||Full Range|Median
1241695|NCT00568776|Secondary|Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
1241696|NCT00568776|Secondary|Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
1241697|NCT00568776|Primary|Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)|The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.|Baseline and 78 weeks|Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.|||Scores on a Scale||Standard Error|Mean
1241698|NCT00568776|Primary|Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)|The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
1241714|NCT00568555|Secondary|Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for sleep quality, 0 to 100, where 0 = did not sleep well at all and 100 = slept extremely well.~Baseline sleep quality calculated by averaging daily scores over the 2 week baseline period.~Placebo and LDN sleep quality scores calculated by averaging daily scores during the final 3 days of each condition.~Values were converted to percent change in sleep quality: [(baseline sleep - end point sleep)/baseline sleep] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline||95% Confidence Interval|Mean
1241699|NCT00568776|Primary|Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)|The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.|Baseline and 78 weeks|Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.|||Scores on a Scale||Standard Error|Mean
1241700|NCT00568776|Secondary|Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
1241701|NCT00568776|Primary|Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)|The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
1241702|NCT00568685|Secondary|Weight Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population|||kilograms (kg)||Standard Deviation|Mean
1241703|NCT00568685|Secondary|Blood Pressure Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population|||mmHg||Standard Deviation|Mean
1241704|NCT00568685|Secondary|Temperature Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population|||degrees Celsius||Standard Deviation|Mean
1241705|NCT00568685|Secondary|Heart Rate Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population|||beats per minute (bpm)||Standard Deviation|Mean
1241706|NCT00568685|Secondary|Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary|Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required.|Baseline to Day 42|As treated population|||participants|||Number
1241707|NCT00568685|Primary|Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic).|Baseline, Day 42|Analysis included all randomized participants (intent-to-treat population)|||units on a scale||95% Confidence Interval|Least Squares Mean
1241708|NCT00568685|Secondary|Adverse Events Leading to Discontinuation|Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency|Baseline to Day 42|As-treated population|||events|||Number
1241709|NCT00568685|Secondary|Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)|Baseline, Days 7, 14, 42|ITT population; LOCF|||units on a scale||Standard Deviation|Mean
1241710|NCT00568685|Secondary|Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, Days 7, 14, 42|ITT population; last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1241711|NCT00568555|Secondary|Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.|A thermode is placed on the palm, and temperature is increased until the first sensation of pain. That temperature is recorded in Degrees Celsius . The procedure is repeated 3 times and results are averaged into a single temperature recording.|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline to final||95% Confidence Interval|Mean
1241712|NCT00568555|Secondary|Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.|An algometer is used to apply pressure to 18 points across the body. Pressure is applied until the first sensation of pain in indicated. This pressure is recorded (as kg/cm2) and averaged for all 18 points to provide an overall score.|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline to final||95% Confidence Interval|Mean
1241713|NCT00568555|Secondary|Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for fatigue, 0 to 100, where 0 = no fatigue at all and 100 = severe fatigue.~Baseline fatigue calculated averaging daily scores over the 2 week baseline period.~Placebo and LDN fatigue scores calculated by averaging daily scores during the final 3 days of each condition.~Values were converted to percent change in fatigue: [(baseline fatigue - end point fatigue)/baseline fatigue] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline||95% Confidence Interval|Mean
1241715|NCT00568555|Primary|Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable.~Baseline pain calculated averaging daily pain scores over the 2 week baseline period.~Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition.~Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline to final||95% Confidence Interval|Mean
1241716|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment|For each patient, a time series plot of the number of IFNγ producing peptide specific CTLs will be constructed. The resulting plots will be visually inspected for trends within and between treatments. A point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of the number of IFNγ producing peptide specific CTLs will be constructed using the properties of the binomial distribution.|up to 2 years|There is not enough participants to perform this analysis.||||||
1241717|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment|For those patients who are HLA-A2+, the maximum post-treatment levels of MART-1, tyrosinase, and gp100 will be determined. For each of these specific melanoma specific antigens, the number of participants (within a given treatment) who gained or maintained immunity based on the maximum post-treatment level of that specific melanoma specific antigen will be determined.|up to 2 years|There is not enough participants to perform this analysis.||||||
1241718|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment|Time series plot of the number of circulating cells will be constructed. The resulting plots will be visually inspected for trends within and between treatments. For each cell type, a point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of circulating cells of that type will be constructed using the properties of the binomial distribution.|up to 2 years|There is not enough participants to perform this analysis.||||||
1241719|NCT00568451|Secondary|Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response|Duration of response was defined as the date at which the participant's objective status was first noted to be either a Complete Response or Partial Response to the date the progression was documented.|up to 2 years|Two complete tumor responses were documented. Both participants have since discontinued the study drug after 35 and 24 cycles respectively, and remain disease-free at 39 and 31.5 months since study entry. There is not enough participants to perform this analysis.||||||
1241720|NCT00568451|Secondary|Survival Time|Survival time was defined as the time from registration to death due to any cause.|up to 2 years||||Months||95% Confidence Interval|Median
1241721|NCT00568451|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from registration to documentation of disease progression. Disease progression was measured according to the RECIST criteria. Progression: At least a 20 percent increase in the sum of of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to 2 years||||Days||95% Confidence Interval|Median
1241722|NCT00568451|Primary|Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|"Response that was noted on 2 consecutive evaluations for at least 4 weeks apart.~CR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs."|Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment|All subjects enrolled, met the eligibility criteria who have signed a consent form and have begun their study treatment were evaluable for response.|||participants|||Number
1241723|NCT00568399|Primary|Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate.|We will compare the annualized coronary calcium volume score obtained at the baseline CT of the coronary arteries with another CT obtained of the same coronary arteries following 5 months of sodium thiosulfate treatment.|5 months|This is a feasibility study and all eligible participants were invited to participate. Out of the 48 participates that started, but only 22 completed.|||mm3/year||Standard Deviation|Geometric Mean
1241724|NCT00568386|Primary|Visual Blur|Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.|3 minutes post dose||||Units on a scale||Full Range|Mean
1241725|NCT00568334|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to study end (Day 86-114)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1241726|NCT00568334|Secondary|Number of Subjects With Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within the 43-day (Days 0-42) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1241737|NCT00568178|Secondary|Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12||Baseline and Week 12|All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received|||mm Hg||95% Confidence Interval|Least Squares Mean
1241727|NCT00568334|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fever [defined as axillary fever ≥ 37.5 degrees Celsius (°C)] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (>) 39.0°C after vaccination. Grade 3 rash = more than (>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
1241728|NCT00568334|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
1241729|NCT00568334|Secondary|Antibody Concentrations Against Varicella Zoster Virus (VZV)|Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].|At 86-114 days after the second vaccine dose (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1241730|NCT00568334|Secondary|Antibody Titers Against Varicella Zoster Virus (VZV)|Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].|At 86-114 days after the second vaccine dose (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Titers||95% Confidence Interval|Geometric Mean
1241731|NCT00568334|Secondary|Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values|Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination.|At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Participants|||Count of Participants
1241732|NCT00568334|Secondary|Number of Seroconverted Subjects for Varicella Antibodies|Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination.|At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Participants|||Count of Participants
1241733|NCT00568334|Primary|Antibody Concentrations Against Varicella Zoster Virus (VZV)|Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].|At 43-57 days after the first vaccine dose (Week 6)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1241734|NCT00568334|Primary|Antibody Titers Against Varicella Zoster Virus (VZV)|Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].|At 43-57 days after the first vaccine dose (Week 6)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Titers||95% Confidence Interval|Geometric Mean
1241735|NCT00568178|Primary|Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36|"The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula:~GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL)~GFR values were compared to the baseline GFR measure.~[Note: For male participants, ages 13 to 17 years, 0.70 was used as~the multiplier in place of 0.55]~Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase."|Baseline and Month 36|Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only individuals who satisfied the criteria.|||Change in GFR mL/min1.73m^2||95% Confidence Interval|Least Squares Mean
1241736|NCT00568178|Primary|Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36|"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment.~*The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase."|Baseline and Month 36|Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only the individuals who satisfied the criteria.|||Percent Change in Pr/Cr||95% Confidence Interval|Geometric Mean
1242380|NCT00562588|Secondary|Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)||90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||participants|||Number
1241738|NCT00568178|Secondary|Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12||Baseline and Week 12|All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received.|||mm Hg||95% Confidence Interval|Least Squares Mean
1241739|NCT00568178|Primary|Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12|"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment.~Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period."|Baseline and Week 12|Full Analysis Set included all randomized participants who took at least one dose of study drug and had baseline and post randomization measurements available|||Percent Change in Pr/Cr||95% Confidence Interval|Geometric Mean
1241740|NCT00568087|Secondary|Alcohol Craving (Obsessive Compulsive Drinking Scale)|"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).~The Obsessive Compulsive Drinking Scale (OCDS) is a self-rated scale designed to assess alcohol craving. The score range of the OCDS is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving."|Alcohol craving (Obsessive Compulsive Drinking Scale) was measured at each weekly visit during the 8 weeks.||||units on a scale||Standard Error|Mean
1241741|NCT00568087|Secondary|Alcohol Craving (Penn Alcohol Craving Scale)|"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).~The Penn Alcohol Craving Scale (PACS) is a self-rated scale designed to assess alcohol craving. The score range of the PACS is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving."|Alcohol craving (Penn Alcohol Craving Scale) was measured at each weekly visit during the 8 weeks.||||units on a scale||Standard Error|Mean
1241742|NCT00568087|Secondary|Liver Function Tests||8 weeks|||||||
1241743|NCT00568087|Primary|Alcohol Consumption (Percentage of Heavy Drinking Days)|The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.|The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.|All 44 subjects who received intervention were included in analysis.|||percentage of heavy drinking days||Standard Error|Mean
1241744|NCT00568061|Secondary|Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, End-diastolic Myocardial Wall Thickness in Infarct, Peri-infarct and Remote Areas, and in Sphericity Index at End-diastole and End-systole||4 months|||||||
1241745|NCT00568061|Secondary|Troponin T Levels and CPK-MB Area Under the Curve||48 hours|||||||
1241746|NCT00568061|Secondary|Resolution of ST Segment Elevation Compared With That Observed at Enrollment||4 hours|||||||
1241747|NCT00568061|Secondary|MI Size as a Fraction of LV Size||4 months|||||||
1241748|NCT00568061|Secondary|Change in Global LV Function and Mass||between 48-72 hours and 4 months|||||||
1241749|NCT00568061|Secondary|Global & Regional LV Function and LV Mass||48-72 hours and 4 months|||||||
1241750|NCT00568061|Secondary|Infarct Transmurality||48-72 hours and 4 months|||||||
1241751|NCT00568061|Secondary|Myocardial Perfusion at Coronary Angiography||at completion of PCI|||||||
1241752|NCT00568061|Secondary|MI Size Normalized to Area at Risk||48-72 hours|||||||
1241753|NCT00568061|Secondary|MI Size at 48-72 Hours||48-72 hours|||||||
1241754|NCT00568061|Primary|Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size|The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).|48-72 hours|Analysis was per intent to treat population|||percent of myocardial infarction size||Standard Deviation|Mean
1241755|NCT00568022|Primary|Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)|The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity.|At the end of Cycle 2 (Day 42)|All participants treated at the highest dose level.|||Participants|||Number
1241756|NCT00568022|Secondary|Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval|CLT = total body clearance as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||L/h||Standard Deviation|Mean
1241757|NCT00568022|Secondary|Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval|Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||Liters||Standard Deviation|Mean
1241758|NCT00568022|Secondary|Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval|T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||Hours||Standard Deviation|Mean
1241759|NCT00568022|Secondary|Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval|AUC = the average area under the concentration curve (AUC [INF]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1241760|NCT00568022|Secondary|Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1241761|NCT00568022|Secondary|Participant Tumor Response at Study Endpoint|Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which complete response (CR) = disappearance of all target lesions; partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; and stable disease (SD) = small changes that do not meet above criteria.|At baseline and after every 42 days (every 2 21-day cycles) after baseline|All treated participants with measurable disease and tumor response.|||Participants|||Number
1241762|NCT00568022|Secondary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug|Baseline to Day 42, continuously|All participants who received at least 1 dose of either ixabepilone or capecitabine.|||Participants|||Number
1241763|NCT00568022|Primary|Participants Experiencing Dose Limiting Toxicity (DLT)|DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.|From initiation of drug through last day of Cycle 2 (Day 42)|All participants who received at least 1 dose of either ixabepilone or capecitabine.|||Participants|||Number
1241764|NCT00567996|Secondary|"Percentage of COPD Days of Poor Control During 26 Weeks of Treatment"|"Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of “days of poor control”, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates."|Up to 26 weeks|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.|||Percentage of days||Standard Error|Least Squares Mean
1241765|NCT00567996|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.|Week 12|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had SGRQ data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF).|||Score on a scale||Standard Error|Least Squares Mean
1241766|NCT00567996|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.|Week 12|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The end point was analyzed only for those participants who had Trough FEV1 data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1241767|NCT00567892|Secondary|Perceived Global Impression of Change (PGIC: Number of Participants With Perceived Global Impression of Change (PGIC) of 1 or Greater|"PGIC is a 7 point scale ranging from -3 to +3,with 0 meaning no change,negative values reporting worsening of symptoms(Tinnitus), and values of +1 or above reporting perceived improvement of Tinnitus.~PGIC score post active rTMS treatment treatment will provide subject's impression of change in tinnitue due to active treatment.PGIC score post rTMS sham will provide subject's impression of change in tinnitus due to sham. Number of subjects with scores of 1 or above are recorded to perceive improvement due to treatment of the corresponding study arm."|End of each treatment period (2 or 4 weeks)|Study participant that successfully completed both study parts active rTMS treatment and sham rTMS treatment were included in analysis.|||participants|||Number
1241768|NCT00567892|Primary|Change in THI (Tinnitus Handicap Inventory)|Tinnitus Handicap Inventory (THI) is a measure of bother from tinnitus. THI is measured as a score in a scale ranging from 0=No bother to 100=Extremely Bothered. THI score post active rTMS treatment minus THI score pre active rTMS treatment will provide the change in THI score due to active treatment. THI score post rTMS sham minus THI score pre rTMS sham will provide change in THI due to sham. The difference of THI change due to active treatment minus THI change due to sham will provide the THI change that is our primary outcome measure.|baseline at the start of each treatment period, end of each treatment period (2 or 4 weeks)|Study participant that successfully completed both study parts active rTMS treatment and sham rTMS treatment were included in analysis.|||units on a scale||95% Confidence Interval|Median
1241787|NCT00567567|Secondary|OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology|Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated.|Up to 3 years||||percent probability||95% Confidence Interval|Number
1241788|NCT00567567|Secondary|Neurologic Symptom Resolution in Patients With Primary Tumors With Intraspinal Extension|Descriptive tabulation of the proportion of patients with resolution of neurologic symptoms by type of symptom.|Up to 5 years|||||||
1241769|NCT00567879|Secondary|Number of Participants With Best Overall Response|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|day 21|The full analysis set was analyzed. The full analysis set included all randomized participants.|||Participants|||Number
1241770|NCT00567879|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.|day 21|The Maximum Tolerated Dose (MTD) determining set was used for this analysis. The MTD determining set consisted of all participants who either received sufficient study drug and had sufficient safety evaluations or discontinued due to unacceptable toxicity.|||Participants|||Number
1241771|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified]||Day 2 and Day 14||||hours/day||Standard Deviation|Mean
1241772|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)||Day 0 and Day 2||||hours/day||Standard Deviation|Mean
1241773|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)||Day 0 and Day 14||||hours/day||Standard Deviation|Mean
1241774|NCT00567840|Secondary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 2-14).||Day 2 and Day 14|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10 CFU/ml||Standard Deviation|Mean
1241775|NCT00567840|Secondary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-2).||Day 0 and Day 2|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10 CFU/ml||Standard Deviation|Mean
1241776|NCT00567840|Primary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).||Day 0 and Day 14|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10 CFU/ml||Standard Deviation|Mean
1241777|NCT00567593|Primary|PDK4 mRNA||14 days||||copies/nL||Full Range|Median
1241778|NCT00567567|Secondary|Type of Surgical Complication|The proportion of patients by type of surgical complication and type of radiation therapy complication will be descriptively tabulated. The complications are: bowel obstruction, chylous leak, renal injury/atrophy/loss and diarrhea.|Up to 3 years|||||||
1241779|NCT00567567|Secondary|Type of Radiotherapy Complication|The proportion of patients by type of surgical complication and type of radiation therapy complication will be descriptively tabulated. The complications are: bowel obstruction, chylous leak, renal injury/atrophy/loss and diarrhea.|Up to 3 years|||||||
1241780|NCT00567567|Secondary|Topotecan Systemic Clearance|Median topotecan systemic clearance for courses 1 and 2.|Day 1 of courses 1-2|Eligible patients evaluated for topotecan systemic clearance.|||L/h/m2||Full Range|Median
1241781|NCT00567567|Secondary|Surgical Response|A chi-square test of proportions will be used to test for association between the proportion of patients who achieve a surgical CR and the proportion of patients who do not relapse in the primary. A logrank test will compare the EFS curves for degree of surgical response (CR vs. < CR).|Up to 3 years|||||||
1241782|NCT00567567|Secondary|Response Rate|A chi-square test of association will be used to compare the proportion of responders with versus without a polymorphism.|42 days|||||||
1241783|NCT00567567|Secondary|Proportion of Patients With Neuroblastoma Detected in Bone Marrow and Peripheral Blood Using RT-PCR Technique|Will be calculated overall and by treatment arm.|Baseline|||||||
1241784|NCT00567567|Secondary|Presence and Function of T Cells Capable of Recognizing Neuroblastoma||Up to 6 months (end of therapy)|The data was not collected to assess this study aim.||||||
1241785|NCT00567567|Secondary|Pharmacogenetic Variants in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies|To determine if pharmacogenomic variations are predictive of EFS, a logrank test comparison of patients with vs without a given polymorphism will be made. A Fisher’s exact test will test for association of the presence of a polymorphism with the occurrence of systemic toxicity (CTC grade 3 or 4 skin, hypercalcemia, or hepatic toxicity). These tests will be performed for UGT1A1, UGT2B7, CYP2C8 and CYP3A7 alleles.|Baseline|||||||
1241786|NCT00567567|Secondary|Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies|Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532|Day 1 of each course|Eligible patients evaluated for peak serum concentration level of isotretinoin.|||Micromolar||Full Range|Median
1241847|NCT00567255|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1241789|NCT00567567|Secondary|Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells|A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed.|Up to 6 months after completion of assigned myeloablation therapy|All eligible patients that had CD3, CD4 and CD8T-cell count evaluated at the end of reporting period 3.|||cells/mm^3||Full Range|Median
1241790|NCT00567567|Secondary|EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).|Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated.|Up to 3 years|All eligible patients non-randomly assigned to single CEM|||percent probability||95% Confidence Interval|Number
1241791|NCT00567567|Secondary|Duration of Greater Than or Equal to Grade 3 Thrombocytopenia|A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.|21 days|||||||
1241792|NCT00567567|Secondary|Duration of Greater Than or Equal to Grade 3 Neutropenia|A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.|21 days|||||||
1241793|NCT00567567|Primary|Response After Induction Therapy|Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion (primary or metastases) with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive.|Study enrollment to the end of induction therapy|Eligible patients evaluated for response at the end of induction therapy.|||Proportion participants that responded||95% Confidence Interval|Number
1241794|NCT00567567|Primary|Incidence Rate of Local Recurrence|Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.|Up to 3 years|Eligible patients randomized or assigned to the single HST (CEM) treatment arm who also received boost radiation.|||Percentage 3-year cumulative incidence||95% Confidence Interval|Number
1241795|NCT00567567|Primary|Event-free Survival Rate|Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)|Three years, from time of randomization|All eligible, randomized patients.|||percent probability||95% Confidence Interval|Number
1241796|NCT00567541|Primary|Relief of Chronic Shoulder Pain|Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.|From baseline to 48 week follow up|Intent to Treat population was analyzed|||participants|||Number
1241797|NCT00567502|Primary|Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events|SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.|Up to 5 years|"Overall treatment safety population. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment. Participants who had exposed to XAGRID (alone or in combination with other) was counted in Xagrid arm and those who had received other ET therapy in the Other (Cytoreductives)."|||participants|||Number
1241798|NCT00567502|Secondary|Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy|Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.|||milligram (mg)||Standard Deviation|Mean
1241799|NCT00567502|Secondary|Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy|Total duration for each participant = sum of [stop date - start date + 1] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.|||days||Standard Deviation|Mean
1241800|NCT00567502|Secondary|Platelet Count||Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60|Overall Treatment Safety population, Here n = participants evaluable at specified time-points. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.|||10^9 per Liter (10^9/L)||Standard Deviation|Mean
1244631|NCT00548262|Secondary|Change From Baseline in Vital Signs: Supine Blood Pressure|Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).|Baseline to Week 2 Follow-up|Safety analysis population|||mmHg||Full Range|Median
1241801|NCT00567502|Secondary|Event Rate of Thrombohaemorrhagic Events|Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.|||participants/100 participant-years|||Number
1241802|NCT00567502|Primary|Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies|Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.|Up to 5 years|First Treatment Safety Population included participants who received cytoreductive therapy at registration. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment.|||percentage of participants|||Number
1241803|NCT00567476|Secondary|Patient's Global Assessment of Treatment Effectiveness|"At the end of Week 20, a global evaluation of the treatment effectiveness was performed by the patient using the following scale:~Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma"|20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.|||Participants|||Number
1241804|NCT00567476|Secondary|Physician's Global Assessment of Treatment Effectiveness|At the end of Week 20 a global evaluation of the treatment effectiveness was performed by the investigator using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma|20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.|||Participants|||Number
1241805|NCT00567476|Secondary|Mean Number of Puffs of Rescue Medication Taken Per Day|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hour period was recorded in the patient dairy. The total number of puffs over 20 weeks of treatment was divided by the number of treatment days (140 days) to calculate the mean number of puffs per day.|From Baseline through 20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population. Number of patients analyzed includes only those patients requiring rescue medication during the study.|||Puffs||Standard Deviation|Mean
1241806|NCT00567476|Secondary|Free Days With no Rescue Medication|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. Days with no rescue medication intake were the variable of interest for this analysis.|From Baseline through 20 weeks (140 days)|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.|||Days||Standard Deviation|Mean
1241807|NCT00567476|Secondary|Percentage of Participants Using Rescue Medication|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm.|From Baseline through 20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.|||Percentage of participants||95% Confidence Interval|Number
1241808|NCT00567476|Secondary|Number of Asthma Exacerbation Episodes Per Participant|For the purpose of evaluating efficacy, a clinically significant asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling the baseline ICS dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the above corticosteroid regimens marked the start of an asthma exacerbation episode and cessation of the additional corticosteroid regimens marked the end of an exacerbation episode.|From Baseline through 20 weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.|||Participants|||Number
1241809|NCT00567476|Secondary|The Mean Change From Baseline to the End of Study in AQLQ Domain Score|"AQLQ was administered to all patients at Baseline, Week 12 and Week 20, and prior to any clinic visit evaluation and drug administration.~The 32 questions in the AQLQ were divided into four domains: activity limitations, symptoms, emotional function, and environmental stimuli. AQLQ domain scores were calculated by adding the responses to each of the questions in the domain and dividing by the number of questions in the domain. Each domain score was between 1 and 7. Score 7.0 meant that the patient had no impairments due to asthma and score 1.0 indicated severe impairment."|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.|||Units on a scale||Standard Error|Mean
1241810|NCT00567476|Primary|The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.|||Units on a scale||Standard Error|Mean
1241811|NCT00567476|Secondary|Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. AQLQ of each domain is the mean of the responses to each of the questions within that domain. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.|||Percentage of participants||95% Confidence Interval|Number
1241812|NCT00567476|Secondary|Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.|||Percentage of participants||95% Confidence Interval|Number
1241813|NCT00567359|Secondary|Median Disease Free Survival|The median amount of time measured from the time of registration until the time of disease recurrence or death.|From registration to disease recurrence or death, up to approximately 9 years|Median Disease Free Survival had not been met by the time of data cutoff.|||years||95% Confidence Interval|Median
1241814|NCT00567359|Secondary|Median Overall Survival|The median amount of time from the time of registration until death due to any cause|From the time of registration until death, up to approximately 9 years||||years||95% Confidence Interval|Median
1241815|NCT00567359|Secondary|Number of Participants With Treat Related Serious Adverse Events|Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) from the start of treatment until 30 days after the end of treatment. Serious adverse events were defined as adverse events that were grade 3 or greater and deemed to be possibly, probably or definitely related to the study treatment.|From the start of treatment until 30 days after the end of treatment, up 13 months total||||Participants|||Count of Participants
1241816|NCT00567359|Primary|2-year Disease-free Survival|The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence.|2 years||||Participants|||Count of Participants
1241817|NCT00567320|Primary|Proportion of Cocaine Positive Urine Tests Per Week|Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysis using a total of 13 longitudinal results that included a baseline result (Week 0).|Weekly Measures over 12 weeks|Intention to treat analysis of all subjects receiving medication|||Proportion of cocaine positive||Standard Deviation|Mean
1241818|NCT00567307|Primary|Reduction of the Estimated 10-year Total Cardiovascular Risk Score|Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk|Six months||||percent||Standard Deviation|Mean
1241819|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy|Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
1241820|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance|Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
1241821|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline|Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
1241822|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 vs. >8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
1241823|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
1241824|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories|Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
1241825|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years)|Participants who responded to the treatment with gabapentin were counted by age (<65 vs. >=65 years) to assess whether the age was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
1241826|NCT00567268|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events.|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||participants|||Number
1241827|NCT00567268|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events.|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||participants|||Number
1241828|NCT00567268|Secondary|Percent Reduction From Baseline in Epileptic Seizure Frequency|Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100.|12 weeks|The analysis population comprised of the participants whose frequency of epileptic seizures during 4 weeks before gabapentin treatment (represented by B) was at least once within the R ratio analysis population.|||Percentage||Standard Deviation|Mean
1241829|NCT00567268|Secondary|Responder Rate|Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.|12 weeks|Responder rate analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population.|||Percentage of participants||95% Confidence Interval|Number
1241830|NCT00567268|Secondary|Response Ratio (R Ratio)|Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure.|12 weeks|R ratio analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population.|||Ratio||Standard Deviation|Mean
1241831|NCT00567268|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency within the safety analysis population. Participants who had disease not eligible for the survey were excluded from the efficacy analysis population.|||Percentage of participants||95% Confidence Interval|Number
1243281|NCT00557193|Secondary|Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blats|In-vitro sensitivity will be described via mean and standard deviation in samples which have acquired resistance to lestaurtinib|Up to 12 weeks||2019-03-31|03/2019||||
1241832|NCT00567268|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||participants|||Number
1241833|NCT00567268|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||participants|||Number
1241834|NCT00567255|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1241835|NCT00567255|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1241836|NCT00567255|Secondary|Change in IDS-SR Total Score|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1241837|NCT00567255|Secondary|Change in Diastolic Blood Pressure||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
1241838|NCT00567255|Secondary|Change in Systolic Blood Pressure||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
1241839|NCT00567255|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1241840|NCT00567255|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1241841|NCT00567255|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1241842|NCT00567255|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1241843|NCT00567255|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1241844|NCT00567255|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1241845|NCT00567255|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1241846|NCT00567255|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 28 weeks||||percent change||95% Confidence Interval|Least Squares Mean
1241848|NCT00567255|Secondary|Change in Waist Circumference||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||cm||Standard Error|Least Squares Mean
1241849|NCT00567255|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1241850|NCT00567255|Secondary|Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56|"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.~Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)."|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1241851|NCT00567255|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1241852|NCT00567255|Secondary|Body Weight- Mean Percent Change From Baseline to Week 56|"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.~Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)."|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
1241853|NCT00567255|Primary|Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28||Baseline, 28 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
1241854|NCT00567242|Secondary|Category Member Generation Probe Scores (% Accuracy)|Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.|trend for time series of 8 baseline + 30 treatment sessions|Data from all subjects completing their respective arms were analyzed, with the exception of one control subject whose baseline was not stable.|||Z score||Standard Deviation|Mean
1241855|NCT00567242|Secondary|Picture Naming Probe Scores (% Accuracy)|Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.|trend for time series of 8 baseline + 30 treatment sessions|Data from all subjects completing their respective arms were analyzed, with the exception that one control subject was eliminated because of an unstable baseline measure.|||Z score||Standard Deviation|Mean
1241856|NCT00567242|Primary|Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production|Functional MRI laterality indices (LIs)were calculated for lateral frontal, medial frontal, and posterior perisylvian cortex regions of interest (ROIs): L=number of active voxels in left hemisphere ROI and R=number of active voxels in right hemisphere ROI using the following formula: (L-R)/(L+R). LIs could vary from -1 (completely right lateralized) to +1 (completely left lateralized). Then, change in LIs was calculated by subtracting the pre-treatment from the post-treatment and 3-mo follow-up LI. It was expected the intention manipulation would show a rightward shift in LI.|immediately post-treatment scan minus pre-treatment baseline scan|Data for all subjects completing the protocol for their respective arm were analyzed.|||laterality index||Standard Deviation|Mean
1241857|NCT00567229|Primary|Final Response Rate After 4 Courses of Treatment||2 years||||participants|||Number
1241917|NCT00566943|Secondary|Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group|Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study.|Discharge and 30 days||||Participants|||Number
1241858|NCT00567190|Secondary|Time to Symptom Progression|Time to symptom progression was defined as the time from randomization to the first symptom progression as measured by the Functional Assessment of Cancer Therapy-for patients with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contains 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer patients (breast cancer subscale [BCS]). All items in the questionnaire were rated by the patient on a 5-point scale ranging from 0 (“not at all”) to 4 (“very much”). The total score ranged from 0 to 96. A higher score indicates better perceived quality of life. A positive change score from baseline indicates improvement. Symptom progression was defined as a decrease from baseline of 5 points or more.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only female patients were included in the analysis.|||Weeks||95% Confidence Interval|Median
1241859|NCT00567190|Secondary|Duration of Objective Response Determined by an Independent Review Facility|Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only patients with an objective response were included in the analysis.|||Weeks||95% Confidence Interval|Median
1241860|NCT00567190|Secondary|Objective Response Determined by an Independent Review Facility|A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only patients with measurable disease at baseline were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
1241861|NCT00567190|Secondary|Progression-free Survival (PFS) Determined by the Investigator|PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as target lesions.|Baseline to the third data cut-off (11 February 2014) at 389 deaths (approximately 43 months after enrollment of the last patient, up to 6 years overall)|Intent-to-treat population: All randomized patients.|||Months||95% Confidence Interval|Median
1241862|NCT00567190|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause. The median and 95 percent (%) confidence interval (CI) for time to event were estimated using Kaplan-Meier methodology.|Baseline to the third data cut-off (11 February 2014) at 389 deaths (approximately 43 months after enrollment of the last patient, up to 6 years overall)|Intent-to-treat population: All randomized patients.|||Months||95% Confidence Interval|Median
1241863|NCT00567190|Primary|Progression-free Survival (PFS) Determined by an Independent Review Facility|PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as target lesions.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat (ITT) population: All randomized patients.|||Months||95% Confidence Interval|Median
1241864|NCT00567164|Secondary|Length of Cycles|Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started.|Up to 1 year|Full Analysis Set (ie, all treated participants). Only cycle data from participants with sufficient data to calculate cycle length are included.|||Days|Participants|Standard Deviation|Mean
1241865|NCT00567164|Secondary|Number of Scheduled and Unscheduled Bleeding Days|Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate scheduled/unscheduled bleeding. Analysis was only performed for the flexible and stop-and-go extended regimens.|||Days||Standard Deviation|Mean
1241866|NCT00567164|Secondary|Number of Intracyclic Bleeding Days|Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate intracyclic bleeding.|||Days||Standard Deviation|Mean
1241867|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 14.|||Percentage of Participants|||Number
1241868|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 13.|||Percentage of Participants|||Number
1241869|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 12.|||Percentage of Participants|||Number
1241870|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 11.|||Percentage of Participants|||Number
1241871|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 10.|||Percentage of Participants|||Number
1241872|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 9.|||Percentage of Participants|||Number
1241873|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 8.|||Percentage of Participants|||Number
1241874|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 7.|||Percentage of Participants|||Number
1241875|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 6.|||Percentage of Participants|||Number
1241876|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 5.|||Percentage of Participants|||Number
1241877|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 4.|||Percentage of Participants|||Number
1241878|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 3.|||Percentage of Participants|||Number
1241879|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 2.|||Percentage of Participants|||Number
1241880|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 1.|||Percentage of Participants|||Number
1241881|NCT00567164|Secondary|Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10.|Day 271 to Day 360|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 4.|||Days||Standard Deviation|Mean
1241882|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7.|Day 181 to Day 270|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 3.|||Days||Standard Deviation|Mean
1241883|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4.|Day 91 to Day 180|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 2.|||Days||Standard Deviation|Mean
1241918|NCT00566943|Primary|Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.|Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.|Discharge/30 Linear Discharge/30/90 days Circular||||Participants|||Number
1247735|NCT00527488|Primary|Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration|The baseline interval concentration is 0.75 x baseline concentration|Day 0-42||||participants|||Number
1241884|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period.|Day 1 to Day 90|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 1.|||Days||Standard Deviation|Mean
1241885|NCT00567164|Secondary|Number of Bleeding Days (Excluding Spotting Days)|Number of days per participant with bleeding (excluding spotting days)|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.|||Days||Standard Deviation|Mean
1241886|NCT00567164|Secondary|Number of Bleeding Days (Including Spotting Days)|Number of days per participant with bleeding or spotting|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.|||Days||Standard Deviation|Mean
1241887|NCT00567164|Primary|Pearl Index|The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.|Up to 1 year|Full Analysis Set of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) treatment arm. Pooled Full Analysis Sets of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) and Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arms.|||Pregnancies per 100 years of exposure||95% Confidence Interval|Mean
1241888|NCT00567112|Secondary|t1/2 for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with t1/2 measurements|||hours||Full Range|Median
1241889|NCT00567112|Secondary|Tmax for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with Tmax measurements|||hours||Full Range|Median
1241890|NCT00567112|Primary|Half Life (t½) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with t1/2 measurements|||hours||Full Range|Median
1241891|NCT00567112|Primary|Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with Tmax measurements|||hours||Full Range|Median
1241892|NCT00567112|Secondary|Cmax of OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with Cmax measurements|||nM||Full Range|Least Squares Mean
1241893|NCT00567112|Secondary|AUC(0-∞) for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with AUC(0-∞) measurements|||nM*hr||Full Range|Least Squares Mean
1241894|NCT00567112|Primary|Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with Cmax measurements|||nM||Full Range|Least Squares Mean
1241895|NCT00567112|Primary|Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)||From study drug administration to 72 hours post-administration|Participants with AUC(0-∞) measurements|||nM*hr||Full Range|Least Squares Mean
1241896|NCT00567008|Primary|Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.|Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.|8 weeks||||participants|||Number
1241897|NCT00566995|Other Pre-specified|Change in Plasma Biomarkers Vascular Endothelial Growth Factor (VEGF) and Soluble Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Before and After Treatment With Vandetanib|5-10cc venous blood was collected for evaluation of basal plasma levels of angiogenesis biomarkers VEGF and VEGFR-2.|Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)|This analysis was intended to be exploratory. Several other studies established that therapy with VEGFR agents modulated serum/plasma VEGF and soluble VEGFR2 levels, but there was no consistent & established correlation with clinical outcome. These analyses were unlikely to add further to our ability to evaluate the major objectives of the study.||||||
1241898|NCT00566995|Secondary|Response in Pheochromocytomas Associated With Von Hippel Lindau (VHL)|Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.|This outcome measure was not done because no participants had measurable lesions.||||||
1241899|NCT00566995|Secondary|Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL)|Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.|Only two participants had target lesions that could be measured.|||Participants|||Count of Participants
1241900|NCT00566995|Secondary|Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL)|Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.|Only two participants had target lesions that could be measured.|||Participants|||Count of Participants
1241901|NCT00566995|Secondary|Effect of Vandetanib (ZD6474) on Circulating Endothelial Cells (CEC)|Peripheral blood was collected and analyzed by multiparametric flow cytometry.|Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)|No samples were received for 2/37 participants.|||CEC per 10^6 mononuclear cells||Full Range|Median
1241902|NCT00566995|Secondary|Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells|Peripheral blood was collected and analyzed by multiparametric flow cytometry for analysis of angiogenesis markers.|Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)|No samples were received for 2/37 patients.|||Cells per 10^6 mononuclear cells||Full Range|Median
1241903|NCT00566995|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as time from initiation of treatment to either progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.||||Months||95% Confidence Interval|Median
1241904|NCT00566995|Secondary|Time To Progression (TTP)|Time to progression is defined as the time from the start of treatment to progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, with death being treated as a censored event. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new lesions, developing a surgical size tumor that should be resected. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.||||Months||95% Confidence Interval|Median
1241905|NCT00566995|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|72 months and 14 days||||Participants|||Count of Participants
1241906|NCT00566995|Primary|Overall Response Rate.|Overall response rate is defined as the percentage of participants with either a partial or complete response occurring at any time after initiation of therapy. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles, up to 2 years||||percentage of participants|||Number
1241907|NCT00566982|Secondary|Visual Evaluation of the Vagina (Baseline & Week 52)||52 weeks|ITT|||participants|||Number
1241908|NCT00566982|Secondary|Change From Baseline in Sex Hormone Binding Globulin Levels||52 weeks|ITT|||nmol/L||Standard Deviation|Mean
1241909|NCT00566982|Secondary|Change From Baseline in Follicle Stimulating Hormone Levels||52 weeks|ITT|||U/L||Standard Deviation|Mean
1241910|NCT00566982|Secondary|Change From Baseline in Luteinizing Hormone Levels||52 weeks|ITT|||U/L||Standard Deviation|Mean
1241911|NCT00566982|Secondary|Change From Baseline in Estradiol Levels||52 weeks|ITT|||nmol/L||Standard Deviation|Mean
1241912|NCT00566982|Primary|Mean Change From Baseline in Vaginal pH||12 weeks|ITT|||pH||Standard Deviation|Mean
1241913|NCT00566982|Primary|Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear||12 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
1241914|NCT00566982|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear||12 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
1241915|NCT00566969|Primary|Percent Days Abstinent From Cocaine - Self Report|Percent Self reported days of abstinence from any cocaine use during the 11 week trial.|11 weeks||||percentage of days||Standard Deviation|Mean
1241916|NCT00566943|Secondary|Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.|Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database.|Discharge, 30 and 90 days||||participants|||Number
1242965|NCT00559377|Secondary|Relationship Between Ki67 and Regional FMISO Uptake in Tumor|The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.|Up to 2 years|11 tissue samples with Ki67 values were compared to FMISO uptake.|||percentage of staining||Standard Deviation|Mean
1241919|NCT00566943|Primary|Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.|Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.|Discharge/ 30 days Linear Discharge/30/90 days Circular||||Participants|||Number
1241920|NCT00566930|Primary|Neck Pain|Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)|Up to 10 months||||cm||Standard Deviation|Mean
1241921|NCT00566930|Secondary|Fear Avoidance Belief, Quality of Life, Range of Motion||One year|||||||
1241922|NCT00566852|Secondary|Overall Survival|Failure for overall survival is death from any cause. Median survival was estimated using the Kaplan-Meier method.|From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.|All eligible patients|||months||95% Confidence Interval|Median
1241923|NCT00566852|Secondary|Median Progression-free Survival Time|Disease progression is defined as the first of the following events: an increase of at least 50% for lesions less than or equal to 1cm, an increase of least 25% for lesions greater than 1cm, appearance of any new brain metastases. Failure for progression-free survival is disease progression or death. Median progression-free survival was estimated using the Kaplan-Meier method.|From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.|All eligible patients|||months||Inter-Quartile Range|Mean
1241924|NCT00566852|Secondary|Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks|The FACT-Br is a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), functional well-being (7 questions) and brain cancer subscale which contains concerns relevant to patients with brain tumors (23 questions). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total is obtained by adding all domains together if the overall question response rate is greater than 80%. Total scores on the FACT-Br range from 0 to 184 with lower scores indicating declining quality of life. Change is calculated as baseline score subtracted from 24-week score.|Baseline and 24 weeks from start of treatment|Eligible patients with FACT-Br score at baseline and 24 weeks.|||units on a scale||Inter-Quartile Range|Median
1241925|NCT00566852|Secondary|Median Time to Neurocognitive Failure|Neurocognitive failure is defined as the first cognitive failure on any of the neurocognitive tests: the HVLT-R for immediate recall, delayed recognition, and delayed recall; the Controlled Oral Word Association Test (COWAT); the Trail-Making Test (TMT) Parts A and B. Cognitive failure for each test is defined as a post-treatment score that meets one of the following criteria: follow-up score is at least 2 standard deviations worse than the patient’s personal baseline score or the patient’s raw score change is greater than the reliable change index. The cumulative incidence approach was used to estimate the median time to neurocognitive failure to account for the competing risks of disease progression and death.|Baseline to 12 months from the start of drug treatment|All randomized eligible patients with neurocognitive scores from baseline to 12 months from start of drug treatment.|||years||95% Confidence Interval|Median
1241926|NCT00566852|Secondary|Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 Weeks|The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.|Baseline, 8, 16, and 52 weeks from the start of drug treatment|Eligible patients with baseline and respective post-baseline measurements|||units on a scale||Inter-Quartile Range|Median
1241927|NCT00566852|Primary|Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks|The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from 24-week value. Imputation methods were used to determine values for all alive patients missing the 24 week assessment. This tool is being used to measure cognitive function, specifically memory.|Baseline and 24 weeks from the start of drug treatment|All eligible patients with Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R delayed recall) at baseline and 24 weeks.|||units on a scale||Inter-Quartile Range|Median
1241928|NCT00566813|Primary|Number of Participants With HbA1c Less Than or Equal to 6.5 & Free of Severe Hypoglycemic Events|HbA1c less than or equal to 6.5 at end of 15 month study participation, and lack of or free from severe hypoglycemic events, defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person and which was associated with either a blood glucose level < 50 mg/dl (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.|At end of 15 month study participation||||participants|||Number
1241929|NCT00566813|Primary|Number of Participants With Insulin Independence at End of Study Participation|Primary efficacy outcome: independence from insulin injections with adequate control of blood glucose in subjects with Type 1 diabetes. Transplant is considered a success when 2 weeks after their last transplant, subjects are not using insulin, and fasting glucose levels do not exceed 7.8 mmol/L (140 mg/dL) more than 3 times/week, and two-hour post-prandial glucose values do not exceed 10 mmol/L (180 mg/dL) more than 4 times/week. During the 15 months after last transplant, a subject will be considered a success if an illness or other event (e.g., high tacrolimus level) causes need for insulin not exceeding 14 days providing evidence of graft rejection is not apparent. The proportion of subjects who are insulin independent and meet criteria for glucose control will be determined at 2 weeks and 1, 3, 6, 12, and 15 months following their final islet transplant.|End of 15 Month Study Participation/Follow-up||||participants|||Number
1241930|NCT00566813|Primary|Number of Participants With Adverse Events Including Laboratory Abnormalities at the End of Study Participation|"Frequency of adverse events including laboratory abnormalities~HbA1C (less than 6.1% is considered normal)~Glucose control and absence of hypoglycemic coma/unawareness, as evidenced by no further requirement for third-party assistance or hospital attendance resulting from a severe hypoglycemic episode~Renal function, measured both by serum creatinine and calculated GFR using the Cockroft & Gault~Lipid profiles for cholesterol, triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL)~PRA~Doppler ultrasound to exclude or document portal vein thrombosis~Immunosuppressive drug trough levels~Renal clearance (GFR)~Liver function tests~Diagnosis of opportunistic infections, e.g., CMV"|15 months after the last transplant|The number of participants analyzed represents the number of subjects in Group 1 (Islet Cells) and Group 2 (Islet Cells + Etanercept + Exenatide)|||participants|||Number
1241931|NCT00566735|Secondary|Baseline Depressive Symptoms|This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with <7 referring to mild-to-no depression, and >23 referring to severe depression.|Participants were questioned at baseline||||Score on the HAM-D-17||Standard Deviation|Mean
1241932|NCT00566735|Secondary|Cognitive Functioning|This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning.|Participants were questioned at baseline and after their last electroconvulsive therapy treatment||||Score on the DMI||Standard Deviation|Mean
1241933|NCT00566735|Primary|Number of Side Effects|This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.|Participants were followed for the duration of hospital stay, an average of 3 weeks||||Number of reported side effects|||Number
1241934|NCT00566722|Secondary|Sleep Problems Index II|"Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from none of the time to all of the time for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement."|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants for all items; as a result, not all participants were included in the analysis.|||Change in scores on a scale||Standard Deviation|Mean
1241935|NCT00566722|Secondary|Percent Activity Impairment Due to Psoriasis|Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was using for missing data. Screening data were not available for all participants.|||Change in percent activity impairment||Standard Deviation|Mean
1241936|NCT00566722|Secondary|Percent Impairment While Working Due to Psoriasis|Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.|||Change in % impairment while working||Standard Deviation|Mean
1241937|NCT00566722|Secondary|Percent Overall Work Impairment Due to Psoriasis|Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.|||Change in % overall work impairment||Standard Deviation|Mean
1241938|NCT00566722|Secondary|Percent Work Time Missed Due to Psoriasis|Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab are included. Last observation carried forward was used for missing data. Screening data were not available for all participants.|||Change in percent time missed||Standard Deviation|Mean
1241939|NCT00566722|Secondary|Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis|The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.|||Change in scores on a scale||Standard Deviation|Mean
1241940|NCT00566722|Secondary|Psoriasis-related Pruritus Assessment|The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus.|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data.|||Change in scores on a scale||Standard Deviation|Mean
1241941|NCT00566722|Secondary|Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16|DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.|Week 4 and Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (score of 0 not achieved) was used for missing data.|||Participants|||Number
1243282|NCT00557193|Secondary|Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blats|In-vitro sensitivity will be described via mean and standard deviation in samples which have primary resistance to lestaurtinib.|Up to 12 weeks||2019-03-31|03/2019||||
1241942|NCT00566722|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0.|From Screening to Week 4 and Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.|||Change in scores on a scale||Standard Deviation|Mean
1241943|NCT00566722|Secondary|Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8|The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.|Weeks 2, 4, and 8|All participants who received at least 1 dose of adalimumab are included. Nonresponder imputation was used for missing data; that is, participants who did not have an evaluation at the time point were assumed to not have achieved a 0 or 1 on the PGA.|||Participants|||Number
1241944|NCT00566722|Secondary|Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening||From Screening to Week 16|All participants who were enrolled and received a dose of adalimumab were included. Non-responder imputation (1 grade of improvement not achieved) was used for missing data.|||Participants|||Number
1241945|NCT00566722|Secondary|Number of Participants Achieving a PGA of Clear (0) at Week 16||Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear [0] not achieved) was used for missing data.|||Participants|||Number
1241946|NCT00566722|Primary|Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16|The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe [extreme red coloration, dusky to deep red coloration]).|Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear or minimal not achieved) was used for missing data.|||Participants|||Number
1241947|NCT00566709|Secondary|Unfavorable Glasgow Outcome Scale (GOS)|"GOS measures the degree of disability associated with the brain injury~Unfavorable GOS included the categories of:~death.~vegetative status.~severe disability."|At hospital discharge, an average of 21 days||||participants|||Number
1241948|NCT00566709|Secondary|Long-term Mortality||1-year after hospital discharge||||participants|||Number
1241949|NCT00566709|Secondary|Length of Intensive Care Unit (ICU) Stay||The length of ICU stay, an avarege of 17 days||||days||Standard Deviation|Mean
1241950|NCT00566709|Secondary|Hospital Mortality||length of the hospital stay, an average of 20 days||||participants|||Number
1241951|NCT00566709|Primary|Percentage of Transfused Patients in Each Group||duration of the protocol, an average of 15 days||||percentage of transfused participant|||Number
1241952|NCT00566709|Primary|Number of Units of Packed Red Blood Cell Transfused|Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol|duration of the protocol, an average of 15 days||||units||Standard Deviation|Mean
1241953|NCT00566696|Secondary|To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants.||five years post-transplant|||||||
1241954|NCT00566696|Secondary|To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment.||five years post-transplant|||||||
1241955|NCT00566696|Secondary|Incidence of Regimen-related Mortality|The incidence of regimen-related mortality in the first 100 days post-transplant is estimated based on binomial distribution.|100 days post-transplant||||Percentage of participants|||Number
1241956|NCT00566696|Secondary|Incidence of Non-hematologic Regimen-related Toxicities|Estimate of the incidence of non-hematologic regimen-related toxicity and regimen-related toxicity in the first 100 days post-transplant. The percentage of participants are reported by maximum grade seen using binomial distribution. Participants were graded for toxicity using Common Terminology Criteria for Adverse Events version 3.0. In general, Grade 1 is mild, 2 is moderate toxicity but generally does not require treatment, 3 is severe enough to require treatment, 4 is life-threatening, and 5 means it was associated with death.|100 days post-transplant||||percentage of participants|||Number
1241957|NCT00566696|Secondary|Disease-Free Survival (DFS)|Estimate the one-year disease-free survival (DFS) for research participants who receive this study treatment. DFS is defined as time from transplantation to the occurrence of relapse or death due to relapse. Patients who are alive at the time of analysis or die due to other causes will be censored at the time of their events. The estimated percentage of participants with DFS at one-year post-transplantation is reported using Kaplan-Meier analysis.|One year post-transplant||||Percentage of participants|||Number
1241958|NCT00566696|Secondary|Overall Survival (OS)|Estimate the one-year overall survival (OS) for research participants who receive this study treatment. OS is defined as time from transplantation to death due to any cause. Patient who are alive at the time of analysis will be censored. The estimated percentage of participants with OS at one-year post-transplantation is reported using Kaplan-Meier analysis.|one year post-transplant||||Percentage of participants|||Number
1241959|NCT00566696|Primary|Event-free Survival (EFS)|To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product. EFS is defined as time from transplantation to the occurrence of relapse or death due to any cause. Patients who are alive at the time of analysis will be censored. The estimated percentage of participants with EFS at one-year post-transplantation is reported using Kaplan-Meier analysis.|one year post-transplant||||Percentage of participants|||Number
1241976|NCT00566527|Secondary|Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL|The percentage of participants with varicella antibody titre ≥ 1.25 gpELISA units/mL 6 weeks after each ProQuad® dose was determined.|Day 132 (6 weeks after ProQuad® Dose 2)|All participants who received ProQuad® and have serology results are included.|||Percentage of participants||95% Confidence Interval|Number
1247736|NCT00527488|Primary|Number of Subjects With Testosterone Concentration ≤0.5 ng/mL||Day 0-42||||participants|||Number
1241960|NCT00566631|Other Pre-specified|Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The BARS included an objective rating (from 0=normal to 3=constantly engaged), two subjective ratings of symptoms of akathisia, namely awareness of restlessness (ranging from 0=absence of inner restlessness to 3=awareness of intense compulsion to move) and reported distress related to restlessness (ranging from 0=no distress to 3=severe), and a global clinical rating of akathisia, ranging from 0 (absent) to 5 (severe). Global rating sub-scale score (that is, global clinical rating of akathisia) was assessed which was scored separately and is the most relevant measure of severity of akathisia. Higher scores indicates worsening akathisia. Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
1241961|NCT00566631|Other Pre-specified|Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The SAS rates 10 items (including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, Glabella tap, tremor and salivation), score ranging from 0 (normal) to 4 (extreme). The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score indicates more severe condition of Extrapyramidal Symptoms. Final evaluation is the last post- baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
1241962|NCT00566631|Other Pre-specified|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none and 4=severe). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
1241963|NCT00566631|Secondary|Number of Participants Satisfied With the Study Treatment|Treatment satisfaction with paliperidone ER was assessed by the Investigator and participant on a 5-point scale: 1 (very good), 2 (good), 3 (reasonable), 4 (moderate) and 5 (poor), at the end of the core treatment phase (which is, Day 42 or early discontinuation) by conducting an interview.|Day 42 or early discontinuation|The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure at given time point.|||Participants|||Number
1241964|NCT00566631|Secondary|Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The day time drowsiness evaluation scale is a self-administered scale that rates day time drowsiness. Participants indicate on an 11-point scale that how often they have felt drowsy within the previous 7 days, score ranged from 0 (not at all) to 10 (all the time). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
1241965|NCT00566631|Secondary|Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The sleep evaluation scale is a self-administered scale that rates quality of sleep. Participants indicate on an 11-point scale that how well they have slept within the previous 7 days, score ranged from 0 (very badly) to 10 (very well). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
1241966|NCT00566631|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PSP assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal & social relationships, self-care & disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a Scale||Standard Deviation|Mean
1247737|NCT00527488|Primary|Duration of Testosterone Concentration Below 0.5 ng/mL|The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level|Day 0-42||||Days||Full Range|Median
1241967|NCT00566631|Secondary|Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data."|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
1241968|NCT00566631|Secondary|Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data.|Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.|||Percentage of participants|||Number
1241969|NCT00566631|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms and disorganized thoughts subscale, consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement (H/E) subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity. Final evaluation is the last post-baseline visit with data.|Baseline, Day 42 and Final Evaluation (Day 42 or early discontinuation)|The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1241970|NCT00566631|Secondary|Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data.|Baseline, Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
1241971|NCT00566631|Primary|Number of Participants With Treatment Response Based on Total PANSS Scale Score|Response was defined as decrease of at least 30 percent in total Positive and Negative Syndrome Scale (PANSS) score from Baseline to endpoint of core phase (which is, Day 42 or early discontinuation). The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, & poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of sum of all 30 PANSS items & ranges from 30 to 210. Higher scores indicate worsening.|Day 42 or early discontinuation|Intent-to-treat (ITT) population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.|||Participants|||Number
1241972|NCT00566579|Primary|Number of Patients With Human Papillomavirus Clearance|At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.|12 months||||participants|||Number
1241973|NCT00566527|Secondary|Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2|The percentage of participants with rashes of interest after receiving ProQuad® Dose 2 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.|Day 132 (6 weeks after ProQuad® Dose 2)|All participants who received ProQuad® Dose 2 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
1241974|NCT00566527|Secondary|Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1|The percentage of participants with rashes of interest after ProQuad® Dose 1 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.|Up to Day 28 (up to 4 weeks after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
1241975|NCT00566527|Secondary|Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1|The percentage of baseline seronegative participants meeting measles, mumps, rubella, and varicella antibody response criteria after the first ProQuad® dose was determined. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Day 42 (6 weeks after ProQuad® Dose 1)|All baseline seronegative participants with immunogenicity data are included.|||Percentage of participants||95% Confidence Interval|Number
1247738|NCT00527488|Primary|Time of Minimal Value of Testosterone (Tnadir)|The time point when the lowest testosterone concentration was measured|Day 0-42||||Days||Standard Deviation|Mean
1241977|NCT00566527|Secondary|GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2|Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the second ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL.|Day 132 (6 weeks after ProQuad® Dose 2)|All participants with seronegative baselines who received ProQuad® Dose 2 and have immunogenicity data available are included.|||GMT||95% Confidence Interval|Geometric Mean
1241978|NCT00566527|Secondary|Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1|Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the first ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL.|Day 42 (6 weeks after ProQuad® Dose 1)|All participants with seronegative baselines who received ProQuad® Dose 1 and have immunogenicity data available are included.|||GMT||95% Confidence Interval|Geometric Mean
1241979|NCT00566527|Primary|Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C|The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined.|Up to Day 28 (up to 28 days after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
1241980|NCT00566527|Primary|Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1|The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined.|Up to Day 28 (up to 28 days after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
1241981|NCT00566527|Primary|Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions|The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined.|Up to Day 28 (up to 28 days after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
1241982|NCT00566527|Primary|Percentage of Participants With Solicited Injection-site Adverse Reactions|The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.|Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
1241983|NCT00566527|Primary|Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2|Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Day 132 (6 weeks after ProQuad® Dose 2)|All baseline seronegative participants with immunogenicity data are included.|||Percentage of participants||95% Confidence Interval|Number
1241984|NCT00566527|Primary|Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2|Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Day 132 (6 weeks after ProQuad® Dose 2)|All baseline seronegative participants with immunogenicity data are included.|||Percentage of participants||95% Confidence Interval|Number
1241985|NCT00566501|Secondary|Mean Change From Baseline in SIB Score|The Severe Impairment Battery (SIB) evaluates the severity of cognitive dysfunction in patients with more advanced dementia.|12 months|||||||
1241986|NCT00566501|Secondary|Mean Change From Baseline in MMSE Score|The Mini-Mental State Examination (MMSE) is a brief, 30-item test of cognitive function.|12 months|||||||
1241987|NCT00566501|Primary|Long-term Safety as Measured by Incidence of Adverse Events During the 12 Month Treatment Period|Adverse events (AEs), including SAEs, were recorded from the time of consent. Recording of AEs ceased after the Final Visit or Early Termination Visit, except that SAEs were monitored for 30 days after study drug discontinuation.|Throughout the study ( 12 months for all AEs and up to an additional 30 days for SAEs)|The Safety Population consisted of all subjects who received at least one dose of donepezil SR 23 mg during Study 328. Two groups were categorized: those who received donepezil 10 mg IR and those who received donepezil 23 mg SR during Study 326.|||participants|||Number
1241988|NCT00566462|Secondary|Change in Caudate and Putamen [^123I]-IBZM Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4||Baseline and Week 4|No data was collected because the study was terminated at the sponsor request due to low enrollment.||||||
1241989|NCT00566462|Primary|Change in Striatal [^123I]-Iodobenzamine (IBZM_ Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4||Baseline and Week 4|No data was collected because the study was terminated at the sponsor request due to low enrollment.||||||
1242054|NCT00565812|Other Pre-specified|Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96||Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||beats per minute (bpm)||Standard Deviation|Mean
1241990|NCT00566254|Secondary|Percent of Participants With =25% and =100% Increase From Baseline in 28-day Seizure Frequency During the Maintenance Period (LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population|||Percentage of Participants|||Number
1241991|NCT00566254|Secondary|Percent of Participants With =50% to < 75% and = 75% Decrease From Baseline in 28-day Seizure Frequency During the Maintenance Period(LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial,and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population|||Percentage of Participants|||Number
1241992|NCT00566254|Secondary|Median Percent Change From Baseline in the 28-day Seizure Frequency During the Maintenance Period (LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number,and type of seizures the subject had. Seizure frequency of simple partial,complex partial,and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population|||Percentage Change in Seizure Frequency||Full Range|Median
1241993|NCT00566254|Primary|Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Maintenance Period(LOCF)|A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. The primary analysis assessed the percent of responders in the Maintenance Period (28- day seizure frequency in Week 8 to Week 20 compared to Week -8 to Week 0 at Last Observation Carried Forward (LOCF)). Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0), and Week 8 to Week 20|The Intent to Treat (ITT)Population was defined as the group of randomized subjects who received at least one does of doubleblind study medication|||Percentage of Participants|||Number
1241994|NCT00566228|Other Pre-specified|Evaluation and Comparison of Immunologic Recovery Within and Between the Arms by Assessing the Quantitative and Functional Immune Effector Cells (T, B, or NK Cells) From the Apheresis Product|Evaluation and comparison of immunologic recovery within and between the arms by assessing the quantitative and functional immune effector cells (T, B, or NK cells) from the apheresis product|Baseline|||||||
1241995|NCT00566228|Secondary|Median Number of CD34 Cells/kg Infused|Five (5) to seven (7) days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greater, stem cell collection began. Apheresis collections were to be performed daily. At least 2 x 10^6 CD34 cells/kg were to be collected. Additional collections were at the discretion of the transplantation team. The median number of CD34 cells/kg infused are reported for each arm below.|5 to 7 days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greater||||x10^6 cells/kg||Full Range|Median
1241996|NCT00566228|Secondary|Median Time to Absolute Lymphocyte Count Engraftment|The time to absolute lymphocyte count (ALC) engraftment will be evaluated and compared between the two arms, where time to ALC engraftment is defined as the time from transplant to the time they achieve ALC > 500.|Up to 30 days after autologous peripheral hematopoietic stem cell transplantation||||days||Full Range|Median
1241997|NCT00566228|Secondary|One-year Overall Survival Rate|Overall survival (OS) was defined at the time from infusion to death from any cause. The one-year OS rate is defined as the percentage of patients who are still alive after one year. A log rank test was used to assess whether OS differed with respect to apheresis collection method.|date of infusion to death from any cause, up to one year||||percentage of patients||95% Confidence Interval|Number
1241998|NCT00566228|Secondary|Progression-free Survival Rate at 2 Years|Progression-free survival rate (percentage) at two years is defined as 100 times the number of patients who have not progressed, relapsed and/or died divided by the total number of evaluable patients in each arm. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the SPD of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm).|Date of infusion to disease progression, relapse, or death from any cause, up to two years||||percentage of patients||95% Confidence Interval|Number
1241999|NCT00566228|Secondary|Progression-free Survival Rate at 1 Year|Progression-free survival rate (percentage) at one year is defined as 100 times the number of patients who have not progressed, relapsed and/or died divided by the total number of evaluable patients in each arm. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the SPD of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm).|Date of infusion to disease progression, relapse, or death from any cause, up to one year||||percentage of patients||95% Confidence Interval|Number
1242000|NCT00566228|Primary|Median Progression-free Survival|Progression free survival (PFS) was defined as the time from the date of infusion to disease progression, relapse, or death from any cause. Patients alive without disease progression or relapse were censored at their last disease evaluation or at their secondary primary cancer diagnosis, whichever occurred first. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the sum of the products of diameters (SPD) of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm). A log rank test was used to assess whether PFS differed with respect to apheresis collection method.|Date of infusion to disease progression, relapse, or death from any cause whichever came first, assessed up to 24 months post enrollment.||||months||95% Confidence Interval|Median
1247739|NCT00527488|Primary|Minimal Value of Testosterone (Cnadir)|The lowest concentration of testosterone measured within the time frame|Day 0-42||||ng/mL||Standard Deviation|Mean
1242001|NCT00566150|Secondary|Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.|Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.|||score on scale||Standard Error|Least Squares Mean
1242002|NCT00566150|Secondary|Number of Subjects Who Achieve Remission.|"Remission response is measured as an HDRS-21 total score is less than or equal to 7.~HDRS-21 measures range of depressive symptoms. Endpoint is LOCF."|Week 6||||Participants|||Number
1242003|NCT00566150|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.|Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.|||score on scale||Standard Error|Least Squares Mean
1242004|NCT00566150|Primary|Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.|Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.|||score on scale||Standard Error|Least Squares Mean
1242005|NCT00566111|Secondary|Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).|The number of patients that had a decrease on CGI-BP at 4 weeks.|4 weeks|only patients with complete data at 4 weeks were analyzed|||participants|||Number
1242006|NCT00566111|Secondary|Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.|The number of patients that had a decrease on MADRS at 4 weeks.|4 weeks|only participants with complete data at 4 weeks were analyzed|||participants|||Number
1242007|NCT00566111|Secondary|Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.||4 weeks|only participants with complete data at 4 weeks were analyzed|||participants|||Number
1242008|NCT00566111|Secondary|Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.|Number of patients with scores that decreased at four weeks.|4 weeks|These data were not collected.||||||
1242009|NCT00566111|Primary|Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.|Number of patients with scores that decreased at four weeks.|4 weeks|only participants with complete data at 4 weeks were analyzed|||participants|||Number
1242010|NCT00566098|Secondary|Anti-tumor Immune Responses|Myeloma lysate response that measures the T-cell response quantified as %CD3+/CFSE-low/IFN-gamma+.|At time of bone marrow harvest, Day 60 post-transplant, Day 180 post-transplant, and Day 360 post-transplant||||%CD3+/CFSE-low/IFN-gamma+||Full Range|Mean
1242011|NCT00566098|Secondary|Pneumococcal-specific Vaccine Responses|CRM-197 Prevnar-specific vaccine responses that measure the T-cell response of the vaccine quantified as %CD3+/CFSE-low/IFN-gamma+.|At time of bone marrow harvest, Day 60 post-transplant, Day 180 post-transplant, and Day 360 post-transplant||||%CD3+/CFSE-low/IFN-gamma+||Full Range|Mean
1242012|NCT00566098|Secondary|Survival|Survival in months for participants who are alive (Overall Survival) and alive without disease progression (Progression-free survival). Disease progression is defined as a change from negative to positive on immunofixation or electrophoresis for participants previously in complete remission or a 25% increase in serum electrophoresis for participants not previously in complete remission. Partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.|Up to 129 months||||months||Full Range|Median
1242013|NCT00566098|Secondary|T-cell Reconstitution as Determined by Absolute Lymphocyte Count (ALC)|ALC counts trending over time.|Days 14, 28, 60, 180, and 360|Data was not collected on one participant at the Day 28 and 180 timepoints, and data was not collected for eight participants at the Day 360 timepoint. Data was not collected on CD3+/CD4+/CD8+ cells for all participants.|||cells per microliter||Full Range|Median
1242014|NCT00566098|Primary|Feasibility of MILs Generation as Assessed by Percentage of Participants With Successful MIL Generation|Success rate of expanding MILs in vitro and obtaining a protocol-specified product.|Up to 1 year||||percentage of participants|||Number
1242015|NCT00566098|Primary|Disease Response|Percentage of participants with partial or complete response by Bladé criteria. Partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.|Up to 2 years||||Participants|||Count of Participants
1242016|NCT00566098|Primary|Hematopoietic Engraftment|Days to absolute neutrophil count > 500 cells per microliter.|Up to 1 year||||days||Full Range|Median
1242017|NCT00566020|Secondary|Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer|PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants without concomitant use of inhibitor and inducer from the date of the first dose of study medication to the date of the last dose. Multiple blood samplings were conducted for some participants. A total of 82 participants were analyzed; 4 participants did not have 200 mg dose data but had data for lower doses.|||Nanograms per milliliter||Full Range|Median
1245556|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
1242018|NCT00566020|Secondary|Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection)|PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants (par.) who took at least one dose of drugs that inhibit lamotrigine glucuronidation (i.e., valproate) from the date of the first dose of study medication to the date of the last dose. A total of 8 par. were analyzed; 1 par. had both 100 and 200 mg data, 4 par. had 100 mg data only, and 3 par. had 200 mg data only.|||Nanograms per milliliter||Full Range|Median
1242019|NCT00566020|Secondary|Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection)|Pharmacokinetic (PK) samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants who took at least one dose of drugs that induce lamotrigine glucuronidation (e.g., carbamazepine) from the date of the first dose of study medication to the date of the last dose.|||Nanograms per milliliter||Full Range|Median
1242020|NCT00566020|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW|The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
1242021|NCT00566020|Secondary|Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW|"The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. For all items, 0 is the best rating and 4 or 8 is the worst rating. YMRS total score was computed as the sum of the scores for the 11 items on the scale. The possible total scores range from 0 (best) to 60 (worst)."|Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
1242022|NCT00566020|Secondary|Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
1242023|NCT00566020|Secondary|Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill).|Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
1242024|NCT00566020|Secondary|Change From Baseline in the Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
1242025|NCT00566020|Secondary|Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Full Analysis Set (FAS): participants who received >=1 dose of study medication and underwent >=1 efficacy assessment. Observed Cases (OC; observed data with no imputation) and Last Observation Carried Forward (LOCF; data imputed [replaced] by most recent observed value [compared to planned date of missing observation]) were used for analysis.|||scores on a scale||Standard Deviation|Mean
1242026|NCT00566020|Primary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW|ECGs were recorded in participants at the indicated time points. ECG findings, as determined by the physicians, were reported as normal, abnormal but not clinically significant (NCS), abnormal but clinically significant (CS), and no result. Specific definitions of ECG categorizations were not provided; physicians were expected to apply reasonable standards of clinical judgment.|Weeks 0, 6, 28, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
1242027|NCT00566020|Primary|Mean Body Mass Index (BMI) of All Participants at Week 0 (Baseline) and Weeks 6, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48, and 52/EW|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.|Baseline (Week 0) and Weeks 0, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||Kilograms per meters squared||Standard Deviation|Mean
1242028|NCT00566020|Primary|Mean Weight of Participants at Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The weight of participants was recorded at the indicated time points.|Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||kilograms||Standard Deviation|Mean
1242029|NCT00566020|Primary|Mean Heart Rate of Participants at Week 0 (Baseline) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Heart rate was measured in participants at the indicated time points.|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||beat per minute||Standard Deviation|Mean
1242030|NCT00566020|Primary|Mean Systolic Blood Pressure and Diastolic Blood Pressure of Participants at Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Systolic and diastolic blood pressure was measured in participants at the indicated time points.|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||Millimeters of mercury||Standard Deviation|Mean
1242031|NCT00566020|Primary|Number of Participants in the Indicated Category for Urine Glucose, Urine Protein, and Urine Urobilinogen at Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Urine glucose, urine protein, and urine urobilinogen were measured in participants at the indicated time points. In this dipstick (qualitative) test, the level of glucose, protein, and urobilinogen in urine samples was recorded as negative (NEG [-]), trace (TRA [+/-]), 1+, 2+, 3+, 4+, and 5+ (the plus sign increases with a higher level of glucose, protein, or urobilinogen in the urine: 1+=slightly positive, 2+=positive, 3+=high positive, 4+=very high positive, 5+=more positive than 4+).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
1242032|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Red Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW|"Red blood cell count was measured in participants at the indicated time points. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: red blood cell count, Male: 4.38-5.77 TI (tebi; 10^12)/L, Female: 3.76-5.16 TI/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
1242033|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Protein, Hemoglobin, and Hematocrit at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for total protein, hemoglobin, and hematocrit at the indicated time points. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: total protein, 65-82 grams per liter (G/L); hemoglobin, Male: 136-183 G/L, Female: 112-152 G/L; hematocrit (proportion of 1), Male: 0.404-0.519, Female: 0.343-0.452."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
1242034|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Platelet Count and White Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for the following clinical laboratory parameters of hematology at the indicated time points: platelet count and white blood cell count. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: platelet count, 140-379 GI (gibi; 10^9) per liter (GI/L); white blood cell count, 3.5-9.7 GI/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
1242035|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Calcium, Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants were evaluated for the following clinical laboratory parameters for blood chemistry at the indicated time points: electrolytes (calcium, chloride, potassium, sodium), cholesterol, triglycerides, and urea/BUN. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges (micromoles per liter [MMOL/L]): calcium, 2.0459-2.495; chloride, 98-108; potassium, 3.5-5; sodium, 135-145; cholesterol, 3.879-5.66334; triglycerides, 0.565-1.6837; urea/BUN, 2.856-7.14."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
1242036|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Bilirubin and Creatinine at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: total bilirubin and creatinine. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: total bilirubin, 3.42-17.1 micromoles per liter (UMOL/L); creatinine, Male: 57.46-96.356 UMOL/L, Female: 40.664-72.488 UMOL/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
1242037|NCT00566020|Primary|Number of Participants With the Indicated Clinical Laboratory Test Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)|"Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: ALP, ALT, AST, GGT, and LDH. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: ALP, 104-338 International Units per liter (IU/L); ALT, 5-45 IU/L; AST, 10-40 IU/L; GGT, Male: 0-79 IU/L, Female: 0-48 IU/L; LDH 120-245 IU/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW)|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
1242038|NCT00566020|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, which does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.|From baseline (Week 0) until 2 weeks after the end of treatment (Week 54)|Safety Population: all participants who received at least one dose of study medication|||participants|||Number
1242039|NCT00565916|Primary|Number of Participants That Had an Increase in Myocardial Fatty Acid Utilization.|Measurements of myocardial fatty acid utilization and oxidation with C[11]-Palmitate and PET in healthy postmenopausal women who take either estrogen alone or with progesterone. The primary outcome measure was designed to determine prospectively whether estrogen will increase the heart's fatty acid utilization and whether progestins will attenuate this effect, in a manner similar to what was seen in an observational study of hormone replacement therapy (HRT) in post-menopausal women. To this end, we had anticipated enrolling 30 healthy post-menopausal women for assessment of cardiac fatty acid metabolism using positron emission tomography (PET) and radioactive C[11]-Palmitate both before and after 3 days of hormone replacement therapy. These volunteers were to be randomized to receive either estrogen alone (E) or combined estrogen/progesterone (EP).|3 days|22 healthy post'menopausal women. These volunteers were to be randomized to receive either estrogen alone, or combined estrogen/progesterone. Efforts were made to access the data, PI left institution and there is no access to the data.|||Participants|||Count of Participants
1242040|NCT00565864|Other Pre-specified|% Fat Mass|% fat mass is measured by dual energy X-ray absorptiometry (DEXA). Measurements are made using a Hologic QDR Discovery A Densitometer (Hologic, Inc., Bedford, MA). Proprietary algorithms calculate % fat mass from DEXA data. Minimum value is 20%. Maximum value is 56%. For the purposes of this study, lower values are considered better.|24 weeks||||percentage of total mass||Standard Error|Mean
1242041|NCT00565864|Other Pre-specified|Lean Body Mass|Lean body mass (LBM) is measured by dual energy X-ray absorptiometry (DEXA). Measurements are made using a Hologic Discovery A Densitometer (Hologic, Inc., Bedford, MA). Proprietary algorithms calculate LBM from DEXA data. Minimum value is 28 kg. Maximum value is 71 kg. For the purposes of this study, higher values are considered better.|24 weeks||||kg||Standard Error|Mean
1242042|NCT00565864|Other Pre-specified|Body Mass Index|Body mass Index (BMI) is calculated as the weight in kg divided by the (height in meters squared). Minimum value is 18 kg/m2. Maximum value is 50 kg/m2. For the purposes of this study, lower values are considered better.|24 weeks||||kg/m2||Standard Error|Mean
1242043|NCT00565864|Other Pre-specified|Daily Energy Intake|Daily caloric intake is measured by 24-hour diet recalls, corrected for lean body mass (LBM). Three 24h food recall interviews are conducted by telephone within one week of the testing visit by research nutritionists trained in the Nutrition Data System for Research (NDSR), a software application for the collection of dietary recall information in a standardized fashion. Data from the phone interviews are manually entered into the NDSR program, which calculated caloric intake. The average of the three diet recalls is used as the outcome. Minimum value is 10 kcal/kg LBM/day. Maximum value is 72 kcal/kg LBM/day. Lower values are considered better for the purposes of this study.|24 weeks|One subject could not be reached by telephone to conduct the diet recalls.|||kcal/kg/day||Standard Error|Mean
1242044|NCT00565864|Other Pre-specified|Physical Activity Energy Expenditure|Physical activity energy expenditure (PAEE) by accelerometry, corrected for lean body mass. The Actical activity monitoring device (Mini Mitter Co Inc, Bend, OR) utilizes a multidirectional accelerometer to monitor the occurrence and intensity of motion, or epoch (137). The Actical device measures 3 cm by 3 cm, weighs 17.0 grams, and is securely attached to a waistband and placed around the waist. The device is worn for 7 days. Data are downloaded from the accelerometer using an ActiReader and converted into total activity counts, average activity (counts per minute), time interval duration (minutes), activity ranges during sedentary, light, moderate, and vigorous activity, and accumulated time within each activity range (minutes). These data are then converted to PAEE by proprietary algorithms. Minimum value is 3 kcal/kg LBM/day. Maximum value is 40 kcal/kg LBM/day. Higher values are better.|24 weeks|A few subjects did not have data collected due to a technical problem with downloading their data from the Actical device.|||kcal/kg LBM/day||Standard Error|Mean
1242375|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value - MCP-1|Changes of special biochemical laboratory value (MCP-1) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||µg/mL||95% Confidence Interval|Geometric Mean
1242045|NCT00565864|Other Pre-specified|Thermic Effect of Food|Thermic effect of food (TEF)is a measurement of energy expenditure over 5 hours following consumption of a standard test meal by indirect calorimetry. Each subject consumes a liquid mixed meal (Ensure, Ross Laboratories, 14% protein, 31.5% fat, and 54.5% carbohydrate) over 5 minutes and sampling for O2 and CO2 is then done by indirect calorimetry for the last 6 min of every 0.5 h for 5 h. For each metabolic measurement the respiratory exchange ratio (respiratory quotient or RQ = VCO2/VO2) is calculated and results converted to kilocalories by the Weir equation. Minimum value is 5 kcal/day. Maximum value is 730 kcal/day. Within this range, higher values are considered to be better for the purposes of this study.|24 weeks|The number of subjects who underwent measurement of thermic effect of food was less than the total number of subjects in the study due to scheduling constraints. TEF measurements take over 5 hours, and some subjects did not have sufficient time to participate in this part of the study, but were still able to conduct the other activities.|||kcal/day||Standard Error|Mean
1242046|NCT00565864|Other Pre-specified|Total Energy Expenditure|Total energy expenditure (TEE) measured by isotopic doubly labelled water (DLW) technique, corrected for lean body mass. A urine sample is collected and analyzed for background enrichment of deuterium and 18-O. The subject then drinks a dose of doubly labeled water at 1.7 gm per kg body weight, Samples are collected 2, 3 and 4 hours and seven days following the DLW dose to determine whole body equilibrium. Samples are measured as a ratio of deuterium to hydrogen in hydrogen gas and 18-O/ 16-O in CO2 using a Europa 20/20 Isotope Ratio Mass Spectrometer (Metabolic Solutions, Inc., Nashau, NH). CO2 production is then used to calculate TEE by Weir's equation. Minimum value is 36 kcal/kg LBM/day. Maximum value is 74 kcal/kg LBM/day. Within this range, higher values are considered to be better for the purposes of this study.|24 weeks|The number of participants analyzed is less than the total number of participants due to a nationwide shortage of doubly labelled water during the study. This meant that not all subjects entered into the study were able to receive the doubly labelled water.|||kcal/kg LBM/day||Standard Error|Mean
1242047|NCT00565864|Other Pre-specified|Motor Learning|Pursuit Rotor Trial 4. This test is performed on a photoelectric pursuit Rotor (Model 30014, Lafayette Instrument Company, Lafayette, IN). Subjects hold a photosensitive wand to maintain contact with a 2 cm. light disk rotating on a variable speed turntable. An initial block of 4 trials is administered at 15, 30, 45, and 60 revolutions per minute. The speed at which the subject remains on-target is the rate at which remaining trials are performed. Three blocks of eight 20-second trials are then administered, with a 20-sec rest after each trial, and a 60-sec rest period after 4 trials. This sequence is repeated after a retention interval of 30 minutes. The measure of interest here is the time the wand maintains on target during the final trial. Minimum score is 0; maximum score is 80 seconds. Higher numbers are better.|24 weeks||||seconds||Standard Error|Mean
1242048|NCT00565864|Other Pre-specified|Declarative Memory|Paragraph Recall - 30 min. Subjects were read a brief story and verbally recalled it immediately and after 30 minutes. The score was the total number of story elements recalled at 30 minutes. Minimum score is 0; Maximum score is 20. Higher scores are better.|24 weeks||||units on a scale||Standard Error|Mean
1242049|NCT00565864|Other Pre-specified|Working Memory|3-Back correct on target. The N-Back test consists of three conditions of increasing load on working memory, the 1-Back, 2-Back and 3-Back. In the 1-Back, letters are presented one at a time on a computer screen for 2 sec (1 sec interstimulus interval) during which the subject responds with a key press if a particular letter appears that had appeared on the previous screen. In the 2-Back, the subject must hold in mind letters and respond when s/he sees a letter that was previously presented two screens back. In the 3-Back, the subject responds when s'he sees a letter that was presented three screens back. N-back test measures the updating and storage functions of working memory. The test is scored as the number of targets correctly identified in each condition. The outcome of interest here is the number correct on target during the 3-Back, which is the most difficult of the three conditions. Minimum score is 0. Maximum score is 16. Higher scores are better.|24 weeks||||units on a scale||Standard Error|Mean
1242050|NCT00565864|Other Pre-specified|Mood|Profile of Mood States (POMS) fatigue subscale. The POMS consists of survey questions that cover 6 subscales: anxiety, confusion, depression-dejection, fatigue, tension, and vigor. Each subscale score is calculated from weighted averages of individual questions related to the subject's perception of fatigue. Minimum score for the fatigue subscale is 0. Maximum score is 30. Higher scores on the POMS fatigue subscale are worse.|24 weeks||||units on a scale||Standard Error|Mean
1242051|NCT00565864|Other Pre-specified|Quality of Life by SF-36 Survey|Short Form Survey (SF-36) mental component summary, which combines results from mental component subscales of the SF-36. The SF-36 health survey (SF-36) is a questionnaire about general health and well-being (127). It consists of 8 subscales (bodily pain, general health, mental health, physical functioning, vitality, role physical, social functioning, role emotional) and two summary scales (Mental Component and Physical Component Summaries). The mental component summary is a weighted average of the 8 subscales, with more weight to role emotional and mental health subscales. Minimum score for the SF-36 mental component summary is 14. Maximum score is 50. Higher scores on the SF-36 summary scales and subscales reflect better health status and well-being.|24 weeks||||units on a scale||Standard Error|Mean
1242052|NCT00565864|Primary|Resting Energy Expenditure|Measurement of resting energy expenditure (REE) by indirect calorimetry, corrected for lean body mass. Indirect calorimetry is performed at 21.1° C after the participant has fasted for 12h and abstains from significant physical activity for 24h. The indirect calorimeter (VMax Encore 29N Indirect Calorimeter, SensorMedics Viasys Healthcare, Yorba Linda, CA) samples expired air and analyzes it for the volume of oxygen consumed (VO2) and the volume of carbon dioxide produced (VCO2) each minute for 30mins. REE is then calculated using the modified Weir equation. Minimum REE is 23 kcal/kg LBM/day and maximum REE is 39 kcal/kg LBM/day. Within that range, higher levels are considered better for the purposes of this study.|24 weeks||||kcal/kg LBM/day||Standard Error|Mean
1242053|NCT00565864|Primary|Executive Function|Iowa Gambling Task Net-5. Four decks of cards are shown face down on a computer screen. The subject chooses cards from any deck, resulting in the gain or loss of money. The subject is unaware that 2 decks are advantageous (small gains, smaller losses), while 2 are disadvantageous (large gains, larger losses). The subject’s choices are classified as advantageous (X) or disadvantageous (Y), with a net score of X-Y, over 5 trials of 100 cards each. The outcome reported here is the score on the fifth trial, which is generally the best trial due to practice effects. The minimum score is -20 and the maximum score is +20. Higher scores indicate a better outcome.|24 weeks||||units on a scale||Standard Error|Mean
1242055|NCT00565812|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96|BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant’s same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.|Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||mmHg||Standard Deviation|Mean
1242056|NCT00565812|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96|Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant’s same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.|Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1242057|NCT00565812|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN), platelet: <0.5*LLN or greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil:<0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine:>1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, lipase >1.5*ULN; urine (specific gravity <1.003 or >1.030, pH <4.5 or >8, glucose, ketones, protein, blood/Hgb greater than or equal to [>=]1); pancreatic amylase >1.5*ULN.|Baseline up to Week 111|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'N' signifies participants evaluable for this outcome measure.|||participants|||Number
1242058|NCT00565812|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities|Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than [>]140 milliseconds [msec]), junctional/paced rhythm, intraventricular conduction delay (>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.|Baseline, Month 3, 6, 12, 18, 24|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
1242059|NCT00565812|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.|Baseline up to 7-10 days after last dose of study drug (Week 111)|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication.|||participants|||Number
1242060|NCT00565812|Secondary|Number of Participants Applicable for Virtual Joint Replacement|A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.|||participants|||Number
1242061|NCT00565812|Secondary|Number of Participants With Joint Space Narrowing Progression|JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.|||participants|||Number
1242062|NCT00565812|Secondary|Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index|The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 [minimum] to 5 [maximum], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.|||participants|||Number
1242063|NCT00565812|Secondary|Patient Global Impression of Change Score|Patient global impression of change was a participant-rated instrument that measured change in participant’s overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1242064|NCT00565812|Secondary|Number of Participants With Decrease in Total Analgesic Medication Use|Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.|Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
1242065|NCT00565812|Secondary|Number of Participants With Increase in Total Analgesic Medication Use|Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.|Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
1242066|NCT00565812|Secondary|EuroQoL-5D Visual Analog Scale Score|The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242067|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
1242068|NCT00565812|Secondary|Number of Participants With EuroQo-5D Pain and Discomfort Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
1242069|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Usual Activity Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
1242070|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Self-Care Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
1242071|NCT00565812|Secondary|Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
1242087|NCT00565812|Secondary|Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24|The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242072|NCT00565812|Secondary|Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242073|NCT00565812|Secondary|Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242074|NCT00565812|Secondary|Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242075|NCT00565812|Secondary|Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242076|NCT00565812|Secondary|Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242077|NCT00565812|Secondary|Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242078|NCT00565812|Secondary|Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242079|NCT00565812|Secondary|Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242080|NCT00565812|Secondary|Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242081|NCT00565812|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242082|NCT00565812|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score – Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24|The KOOS-PS was used to rate participant’s opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242083|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24|The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242084|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24|The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242085|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24|The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242086|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24|The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluated for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242136|NCT00565448|Secondary|Overall Survival (OS) Rate|OS rate is the percentage of participants who survived 3 years after completion of consolidation treatment period. The Kaplan-Meier method was used to estimate OS rate.|3 years after the end of the consolidation treatment period (up to 40 months from randomization)|ITT population: all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1242088|NCT00565812|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24|Physician assessed the overall impact of arthritis on the participant’s daily life. Participant’s condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242089|NCT00565812|Secondary|Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition."|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242090|NCT00565812|Secondary|Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24|Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||mm||Standard Deviation|Mean
1242091|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24|The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242092|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24|Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242093|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24|The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242094|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24|The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1242095|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3|Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG =3 and evaluable for this outcome measure.|||mm/year||Standard Deviation|Mean
1242096|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2|Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG <=2 and evaluable for this outcome measure.|||mm/year||Standard Deviation|Mean
1242376|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value- MMP-9|Changes of special biochemical laboratory value (MMP-9) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||ng/mL||95% Confidence Interval|Geometric Mean
1242097|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing|Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'number of participants analyzed' (N) signifies participants evaluable for this outcome measure.|||mm/year||Standard Deviation|Mean
1242098|NCT00565747|Secondary|Live Birth|Subject having at least one live birth. Including a foetus which breathes or shows any other evidence of life after expulsion/extraction from its mother. The definition is independent of the duration of the pregnancy (ICMART/WHO criteria).|Until 7 days after birth|PP-population|||percentage of transfer patients|||Number
1242099|NCT00565747|Secondary|Number of Top Quality Embryos (TQE´s)|Number of 4-5 cell embryo at 44 hours,at least 7 cell embryo at 68 hours, maximum 20% fragmentation, equally large blastomeres (less than 25% difference in size),No signs of multinucleation. Calculated in percentage of number of 2 pronuclei (2PN) oocytes.|3 days from oocyte pick-up|PP-population|||percentage of 2PN's|||Number
1242100|NCT00565747|Primary|Ongoing Implantation Rate Week 7|Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred.|Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation)|PP-population|||percentage of transferred embryos|Participants||Number
1242101|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
1242102|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
1242103|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
1242104|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
1242105|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
1242106|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
1242107|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
1242162|NCT00565409|Secondary|Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88|PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; LOCF|||units on a scale||Standard Error|Least Squares Mean
1242108|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
1242109|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
1242110|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
1242111|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.~Twelve (12) of the 22 subjects had renal cell carcinoma (RCC) the remaining subjects did not have RCC.~SUVR_55_blood is the standard uptake value ratio (tumor-to-blood) at 55 minutes post-injection."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
1242112|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.~SUVw_55 is the standard uptake value at 55 minutes post-injection, normalized to weight."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
1242113|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
1242114|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak αvβ5 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.60 to 0.44 equals a moderately positive correlation and 0.33 to 0.37 equals a weak positive correlation.~Two (2) of the 22 subjects did not have any αvβ5 integrin results."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
1242115|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.~The Logan plot is the counterpart of the Patlak plot for reversible radiotracers."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
1242116|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.22 and 0.24 equals a weak positive correlation and 0.16 and 0.18 equals a negligible correlation.~Three (3) of the 22 subjects did not have any αvβ3 integrin results. Ki-inp-Patlak is a graphical analysis technique based on the compartment model that uses linear regression to identify and analyze pharmacokinetics of tracers involving irreversible uptake."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
1242117|NCT00565669|Primary|Change in Schirmer’s Scores|The Schirmer score is a score on a scale - minimum is 0 and the highest is 35 mm. Above 15 mm is normal and less than 5 is severe dry eyes. A positive score means there was an improvement, 0 will be no change from baseline and a negative one that there was a decreased in tears. This change was calculated by subtracting the baseline value from the 3 months value (3 mo Schirmer’s – baseline Schirmer’s = amount of change).|baseline to 3 months||||score on a scale||Standard Error|Mean
1242118|NCT00565643|Secondary|Operative Times at Subsequent Delivery|Amount of time spent at the time of the subsequent delivery|3 to 5 years||||minutes||Full Range|Median
1242119|NCT00565643|Secondary|Post-operative Maximum Temperature Following Randomization|Maximum temperature of patient, >24 hours following randomization delivery|1 to 5 years||||degrees Fahrenheit||Standard Deviation|Mean
1242120|NCT00565643|Secondary|Post-Operative Complications|Percentage of patients experiencing any of the predefined post-operative complications following randomization|1 to 5 years||||% of patients experiencing complication|||Number
1242121|NCT00565643|Secondary|Post-operative White Blood Cell Count|Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups|1 to 5 years||||cells/mm^3||Standard Deviation|Mean
1242122|NCT00565643|Primary|Adhesion Score|Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).|3 to 5 years||||units on a scale||Full Range|Median
1242123|NCT00565643|Secondary|Post-operative Hemoglobin|Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups|1 to 5 years||||% of blood that is red blood cells||Standard Deviation|Mean
1242124|NCT00565643|Primary|Incidence of Adhesions|The Percentage of participants with one or more adhesions, regardless of the extent or severity|3 to 5 years||||percentage of patients with adhesions|||Number
1242125|NCT00565617|Primary|HDRS-24 Items|"Hamilton Depression Rating Scale (HDRS) is a standard, validated depression rating scale.~It is a 24 item scale, but the primary score is based on the first 17 answers for a total score for depression.~0-7=Normal 8 - 13 = Mild Depression 14-18 = Moderate Depression 19 - 22 = Severe Depression > 23 = Very Severe Depression"|7 months from baseline||||units on a scale||Standard Deviation|Mean
1242126|NCT00565604|Secondary|Secondary Safety Objective|Safety: Incidence rate of device-related minor adverse events.|6 Months|The number of subjects that were enrolled in the trial.|||Participants|||Number
1242127|NCT00565604|Secondary|Secondary Effectiveness Objective|Effectiveness: The reduction in patient symptoms and the satisfaction of the patient. Patient symptom assessment - CEAP Class, best=0 (no visible or palpable signs of venous disease) & worst=6 (Skin changes in conjunction with active ulceration), VDS, best=0 (asymptomatic) & worst=3 (unable to carry out usual activities even with compression and/or limb elevation) and VCSS, best=0 (absent) & worst=3 (severe). Patient satisfaction - modified Odom’s criteria, best=excellent (I am very satisfied with the results of my laser treatment) & worst=poor (I am not satisfied with the results).|6 Months|The number of patients still participating in the study at 6-months.|||Participants|||Number
1242128|NCT00565604|Primary|Primary Safety Objective|Safety: Evaluation of occurrence of major device-related adverse events through 6 weeks and the total at 6 months.|6 Months|The number of patients that were enrolled in the study.|||Participants|||Number
1242129|NCT00565604|Primary|Primary Effectiveness Objective|The primary objective is to demonstrate the clinical effectiveness (as determined by the absence of flow within the treated incompetent perforated vein [IPV])) of endovenous laser ablation. The number of treated IPVs that are closed at 6 weeks and remain closed at 6 months.|6 Months|The number of patients still participating in the study at 6-months.|||Treated IPVs|Participants||Number
1242130|NCT00565461|Primary|Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA"|Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology|||percentage of study participants||95% Confidence Interval|Number
1242131|NCT00565461|Primary|GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data."|Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology|||geometric mean fold ratio||95% Confidence Interval|Number
1242132|NCT00565461|Secondary|Safety and Evaluation of Immunogenicity for Self-administration In-clinic Compared to Self-administration Away From the Clinic.||6 months|||||||
1242133|NCT00565461|Secondary|Evaluation of Immunogenicity for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.||6 months|||||||
1242134|NCT00565461|Secondary|Safety of Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch||6 months|||||||
1242135|NCT00565461|Primary|GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~GMT: geometric mean titer"|Day 0, Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology|||geometric mean titers||95% Confidence Interval|Geometric Mean
1242137|NCT00565448|Secondary|Overall Response (OR)|OR is classified as CR, partial response (PR), stable disease (SD), progressive disease (PD) or Unknown on completion of both induction and radiation treatment and assessed according to the Modified RECIST from the NCI. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as ≥30% decrease in the sum of the longest diameters (LD) of TLs, taking as reference the disease measurement done at study entry. PD is defined as ≥20% increase in the sum of the LD of TLs, taking as a reference the smallest disease measurement recorded at study entry or the appearance of ≥1 new lesions or unequivocal progression of non-TLs. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|after the completion of the consolidation treatment (up to 18 weeks)|ITT population: all randomized participants.|||participants|||Number
1242138|NCT00565448|Secondary|Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group|AUC estimated by Bayesian method using concentration–time data for each participant and the previously defined adult population model as prior information (with validity of the estimation verified).|Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion|Participants who were randomized to docetaxel/cisplatin/5-FU and had evaluable docetaxel pharmacokinetic (PK) sample.|||µg*h/mL||Standard Deviation|Mean
1242139|NCT00565448|Primary|Number of Participants With Complete Response (CR)|CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.|after the completion of the induction treatment (up to 9 weeks)|ITT population: all randomized participants.|||participants|||Number
1242140|NCT00565409|Secondary|DAS28 at Week 36|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm).|Week 36|P2 mITT; LOCF|||units on a scale||Standard Error|Mean
1242141|NCT00565409|Secondary|Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR90 response: ≥ 90% improvement in tender joint count; = 90% improvement in swollen joint count; and = 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF|||percentage of participants|||Number
1242142|NCT00565409|Secondary|Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR90 response: ≥ 90% improvement in tender joint count; = ≥90% improvement in swollen joint count; and = at least 90% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; LOCF|||percentage of participants|||Number
1242143|NCT00565409|Secondary|Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and C-Reactive Protein CRP.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
1242144|NCT00565409|Secondary|Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
1242145|NCT00565409|Secondary|Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
1242146|NCT00565409|Secondary|Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
1242147|NCT00565409|Secondary|Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR20 response: ≥ 20% improvement in tender joint count; ≥20% improvement in swollen joint count; and = at least 20% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF; N=number of participants with evaluable data|||percentage of participants|||Number
1242163|NCT00565409|Secondary|PtGA of Arthritis Pain at Week 36|PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity).|Week 36|P2 mITT; LOCF|||units on a scale||Standard Error|Mean
1242148|NCT00565409|Secondary|Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36|ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
1242149|NCT00565409|Secondary|Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88|EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.|Week 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
1242150|NCT00565409|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36|EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
1242151|NCT00565409|Secondary|Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88|PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).|Weeks 36, 64 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
1242152|NCT00565409|Secondary|Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36|PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).|Baseline, Week 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants||95% Confidence Interval|Number
1242153|NCT00565409|Secondary|Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF|||mm||Standard Error|Least Squares Mean
1242154|NCT00565409|Secondary|Pain at Week 36|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = pain as bad as it could be. Change = Week x observation minus (-) Baseline observation.|Week 36|P2 mITT; LOCF|||mm||Standard Error|Mean
1242155|NCT00565409|Secondary|Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation – Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||mm||Standard Error|Mean
1242156|NCT00565409|Secondary|Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88|"General Health VAS is a 100 mm line marked by the participant. Participants were asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Week 36 observation."|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; N=number of participants with evaluable data; LOCF|||mm||Standard Error|Least Squares Mean
1242157|NCT00565409|Secondary|General Health at Week 36|"General Health VAS is a 100 mm line marked by the participant. Participants are asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad."|Week 36|P2 mITT; LOCF|||mm||Standard Error|Mean
1242158|NCT00565409|Secondary|Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36|"General Health VAS is a 100 millimeter (mm) line marked by the participant. Participants were asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Baseline observation."|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||mm||Standard Deviation|Mean
1242159|NCT00565409|Secondary|Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; N=number of participants with evaluable data; LOCF|||min||Standard Error|Least Squares Mean
1242160|NCT00565409|Secondary|Duration of Morning Stiffness at Week 36|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded.|Week 36|P2 mITT; N=number of participants with evaluable data; LOCF|||min||Standard Error|Mean
1242161|NCT00565409|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour times [*] 60 min) was recorded. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||minutes (min)||Standard Deviation|Mean
1242164|NCT00565409|Secondary|Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36|Participants asked to rate their overall arthritis activity by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||units on a scale||Standard Error|Mean
1242165|NCT00565409|Secondary|Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF|||units on a scale||Standard Error|Least Squares Mean
1242166|NCT00565409|Secondary|PGA Score at Week 36|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity.|Week 36|P2 mITT; LOCF|||units on a scale||Standard Error|Mean
1242167|NCT00565409|Secondary|Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||units on a scale||Standard Error|Mean
1242168|NCT00565409|Secondary|Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88|Total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.|Weeks 36 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||number of painful joints||Standard Error|Least Squares Mean
1242169|NCT00565409|Secondary|Painful Joint Count at Week 36|A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible score ranged form 0-28.|Week 36|P2 mITT; LOCF|||number of painful joints||Standard Error|Mean
1242170|NCT00565409|Secondary|Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36|A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||number of painful joints||Standard Error|Mean
1242171|NCT00565409|Secondary|Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88|ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.|Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF|||number of swollen joints||Standard Error|Least Squares Mean
1242172|NCT00565409|Secondary|Prorated Swollen Joint Count at Week 36|ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by number of non-missing swollen joints). Total possible score of swollen joints ranged from 0-28.|Week 36|P2 mITT; LOCF|||number of swollen joints||Standard Error|Mean
1242173|NCT00565409|Secondary|Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36|American College of Rheumatology (ACR), swollen joint count were an assessment of 28 joints. Joints are classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation – baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||number of swollen joints||Standard Error|Mean
1242174|NCT00565409|Secondary|Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88|DAS28 calculated from the number of SJC and PJC using the 28 joints, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 < 3.2 units = low disease activity. Cumulative proportion calculated as time-averaged Area Under the Curve (AUC) (AUC divided by number of weeks at that time point), with AUC calculated from Week 36 and Week 88.|Week 36 up to Week 88|P2 mITT; LOCF|||proportion of weeks in DAS28 <3.2||Standard Error|Mean
1242175|NCT00565409|Secondary|Time to Loss of Low Disease Activity DAS28|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 greater than (>)3.2 to 5.1 units = moderate to high disease activity.|Week 36 up to Week 88|P2 mITT;|||days||95% Confidence Interval|Median
1242176|NCT00565409|Secondary|Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. Low disease activity = DAS28 ≤ 3.2 units. DAS28 > 3.2 to 5.1 units = moderate to high disease activity.|Week 36 up to Week 88|P2 mITT;Imputation of failure; observed cases|||days||95% Confidence Interval|Median
1245557|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population||Week 104|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1242177|NCT00565409|Secondary|Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF; N=number of participants with evaluable data|||units on a scale||Standard Error|Least Squares Mean
1242178|NCT00565409|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient’s global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; Last observation carried forward (LOCF); N=Number of participants with evaluable data|||units on a scale||Standard Error|Mean
1242179|NCT00565409|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity or Remission|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|Period 2 (P2) mITT|||Percentage of participants|||Number
1242180|NCT00565409|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.|Baseline, Weeks 4, 8, 12, 20, 28, 36|Period 1 Modified Intent to Treat population (P1 mITT): all participants who took at least 1 dose of open-label test article; N=number of participants with evaluable data; Last observation carried forward (LOCF)|||percentage of participants|||Number
1242181|NCT00565409|Primary|Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than [<]20 percent [%] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity.|Week 88|Modified Intent to Treat population (mITT): all participants who took at least 1 dose of double-blind test article and had at least 1 post-randomization DAS28 evaluation|||percentage of participants|||Number
1242182|NCT00565370|Secondary|Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib|28weeks||||participants|||Number
1242183|NCT00565370|Secondary|Overall Survival||28 months||||Months||95% Confidence Interval|Median
1242184|NCT00565370|Secondary|Response Rate|"Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate"|6 months|Patients who had measurable lesions were included for the response rates|||percentage of participants||95% Confidence Interval|Number
1242185|NCT00565370|Primary|Progression-free Survival||1 year||||Months||95% Confidence Interval|Median
1242186|NCT00565370|Primary|Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)|Number of Participants who Experienced Dose Limiting Toxicities (DLTs)|28weeks||||participants|||Number
1242187|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Proportion of Asthma Control Days|An asthma control day was defined as a day in which there were no symptoms and no albuterol (rescue) puffs.|An asthma control day was determined daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||proportion of asthma control days||Standard Error|Least Squares Mean
1242188|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Albuterol Rescue Puffs Per Day|Total number of puffs from the albuterol (rescue) inhaler during the previous 24 hours (excluding those puffs for preventive use).|Albuterol rescue puffs were measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||puffs per day||Standard Error|Least Squares Mean
1242189|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Asthma Control Questionnaire Score|Scores on the Asthma Control Questionnaire range from 0 to 6, with a higher score indicating worse asthma control.|The asthma control questionnaire score was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
1242377|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value- CRP|Changes of special biochemical laboratory values (CRP) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||mg/L||95% Confidence Interval|Geometric Mean
1242190|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Asthma Quality-of-life Questionnaire Score|Scores on the Asthma Quality-of-Life Questionnaire range from 1 to 7, with a higher score indicating a better quality of life.|The asthma quality-of-life questionnaire score was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
1242191|NCT00565266|Secondary|Change Between Week 14 and Week 0 in Asthma Symptoms|"Asthma symptoms were recorded as 0 (absent = no symptom )~(mild = symptom was minimally troublesome, i.e. not sufficient to interfere with normal daily activity or sleep)~(moderate = symptom was sufficiently troublesome to interfere with normal daily activity or sleep)~(severe = symptom was so severe as to prevent normal activity and/or sleep )"|Asthma symptoms were measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
1242192|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Forced Expiratory Volume in One Second (FEV1)||FEV1 was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||liters||Standard Error|Least Squares Mean
1242193|NCT00565266|Primary|Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF)||AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||Liters per minute||Standard Error|Least Squares Mean
1242194|NCT00565136|Other Pre-specified|Pudendal Nerve Terminal Motor Latency|Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both.|Baseline (pre-treatment), 6 Month post-treatment||||msec||Standard Deviation|Mean
1242195|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Tolerable Volume||Baseline (pre-treatment), 6 Month post-treatment||||cc||Standard Deviation|Mean
1242196|NCT00565136|Other Pre-specified|Anal Manometry: Rectal First Sensation||Baseline (pre-treatment), 6 Month post-treatment||||cc||Standard Deviation|Mean
1242197|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Squeeze Pressure||Baseline (pre-treatment), 6 Month post-treatment||||mmHg||Standard Deviation|Mean
1242198|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Resting Pressure||Baseline (pre-treatment), 6 Month post-treatment||||mmHg||Standard Deviation|Mean
1242199|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure||Duration of the device implant procedure (an average of 23 minutes)|All enrolled/implanted subjects were included in this analysis|||ml||Standard Deviation|Mean
1242200|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Length of Hospital Stay||Length of the hospital stay for the device implant procedure|All enrolled/implanted subjects were included in this analysis|||hours||Standard Deviation|Mean
1242201|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Length of Procedure||Duration of the device implant procedure|All enrolled/implanted subjects were included in this analysis|||minutes||Standard Deviation|Mean
1242202|NCT00565136|Secondary|Pain Intensity as Measured by the Pain Intensity Scale|The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.|Baseline (pre-treatment), 6 Week post-treatment|"The Pain Intensity Scale was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29"|||units on a scale||Standard Deviation|Mean
1242203|NCT00565136|Secondary|Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life|The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale.|Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Fecal Incontinence Quality of Life Assessment was completed by the number of subjects at each visit as follows:~Baseline: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"|||units on a scale||Standard Deviation|Mean
1242204|NCT00565136|Post-Hoc|Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline|Includes solid and liquid stools, as measured by a subject-reported bowel diary|6 Weeks, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"Two subjects were enrolled who recorded no FI episodes at baseline and were excluded from this analysis. Missing data was not imputed and was considered a treatment failure.~The Bowel Diary was completed by the number of subjects at each visit as follows:~6 Week: N=24, 3 Month: N=25, 6 Month: N=22, 12 Month: N=21, 24 Month: N=24"|||percentage participants||90% Confidence Interval|Number
1242205|NCT00565136|Secondary|Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence|The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1–6, 7–10, and 11–13 were categorized as mild, moderate, and severe fecal incontinence, respectively.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Symptom Severity Scale in Fecal Incontinence was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"|||units on a scale||Standard Deviation|Mean
1242230|NCT00564902|Secondary|Glare Recovery|Photostress glare recovery test involves exposing an individual eye to intense light, or retinal bleach, for a set duration of time and measuring the time taken for visual acuity to recover to a predetermined level. Glare photo-stress recovery (in seconds) following 30 seconds of continuous retinal bleach, was assessed using 2 line supra-threshold low contrast randomly presented Landolt Cs using the KOWA AS14B Night Vision Tester (KOWA Optimed, Tokyo, Japan).|12 Months|Eyes of all patients still in the trial were measured|||Seconds||Standard Error|Mean
1242206|NCT00565136|Secondary|Fecal Incontinence Symptoms as Measured by the Wexner Score|The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Wexner Score was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"|||units on a scale||Standard Deviation|Mean
1242207|NCT00565136|Secondary|Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period|Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29)|Through 24 month post-treatment|Includes all subjects implanted with the TOPAS device|||events per 24 months/participant|||Number
1242208|NCT00565136|Primary|Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment|Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The FI Bowel Diary was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=26, 3 Month: N=27, 6 Month: N=24, 12 Month: N=23, 24 Month: N=26"|||Number of FI episodes/14 day period||Standard Deviation|Mean
1242209|NCT00565110|Secondary|Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey|The SF-12 measures 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. PCS is a summary score measuring physical health derived by summing responses across scale items and then transforming to a 0-100 scale (higher scores indicate better health).|12 months||||units on a scale||Standard Error|Mean
1242210|NCT00565110|Primary|Reduced Depression Symptoms|Number of participants with 50% PHQ-9 score reduction since baseline|12 months||||Participants|||Count of Participants
1242211|NCT00565084|Primary|Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks|"Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk.~Change from baseline was average of post-dose PIs minus average of pre-dose PI."|All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)|This is a crossover study. Total number of participants was 33; every participant had one ibuprofen period and two placebo periods.|||Units on a Scale||Standard Deviation|Least Squares Mean
1242212|NCT00565058|Secondary|Summary of Treatment Emergent Adverse Events|An adverse event (AE) was defined as any unintended or undesirable experience that occurred during the course of the clinical investigation, regardless of whether or not it was considered to be study drug-related. This included any newly occurring event or a previous condition that had increased in severity or frequency since the administration of study drug.|30 days after the last dose|All Treated Patients population.|||participants|||Number
1242213|NCT00565058|Primary|Overall Response Rate of GTI-2040 Combined With HiDAC in Refractory or Relapsed AML|Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.|at 29-35 days|All Treated Patients population|||participants|||Number
1242214|NCT00565045|Secondary|Fugl-Meyer Assessment (Upper Extremity)|The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better).|3 months post-treatment.|The participants who completed the 6-week treatment phase were analyzed.|||units on a scale||Standard Error|Mean
1242215|NCT00565045|Secondary|Arm Motor Abilities Test|The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn’t participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5.|3 months post-treatment.|The participants who completed the 6-week treatment phase were analyzed.|||units on a scale||Standard Error|Mean
1242216|NCT00565045|Secondary|Box and Blocks Score|The number of blocks picked up and moved across a barrier in 60 seconds|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.|||blocks||Standard Error|Mean
1242217|NCT00565045|Secondary|Finger Tracking Error|A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM.|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.|||% AROM||Standard Error|Mean
1242262|NCT00564681|Secondary|Physician’s Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1|Physician’s global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Intent-to-Treat: All enrolled patients|||Scores on a Scale||Standard Deviation|Mean
1242218|NCT00565045|Primary|Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)|A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.|||degrees||Standard Error|Mean
1242219|NCT00564954|Primary|Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day|SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.|0 hr and 0.5 hr post-dose|Intent to Treat (ITT) population: All randomized patients who had at least one dose of study medication and who had at least one post-dose efficacy measurement.|||score on a scale||Standard Error|Least Squares Mean
1242220|NCT00564954|Secondary|Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test|Number of math questions answered correctly within a 10 minute period.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population.|||questions correct||Standard Error|Least Squares Mean
1242221|NCT00564954|Secondary|Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test–Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)|Number of math questions attempted within a 10 minute period.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population|||questions attempted||Standard Error|Least Squares Mean
1242222|NCT00564954|Secondary|Change From Pre-dose in SKAMP Deportment Score|SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population.|||score on a scale||Standard Error|Least Squares Mean
1242223|NCT00564954|Secondary|Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)|SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42.|0, 0.5, 1, 2, 4, 6, and 8 hours|Intent to Treat (ITT) population|||score on a scale||Standard Error|Least Squares Mean
1242224|NCT00564954|Secondary|Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)|SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.|0, 1, 2, 4, 6, and 8 hr|Intent to Treat (ITT) population|||score on a scale||Standard Error|Least Squares Mean
1242225|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering light emitting diodes and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated.|12 months|All participants in all arms were tested|||Density units of Macular Pigment (du)||Standard Error|Mean
1242226|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).|8 months|All participants in all arms were tested|||Density units of Macular Pigment (du)||Standard Error|Mean
1242227|NCT00564902|Secondary|100% Kinetic Field|Scotomas within the central 20 degree central macula visual field sensitivity was assessed at 5 contrast levels (20, 40, 60, 80, and full contrast). A yellow wavelength stimulus avoided confounding by the lens. Subjects outlined the boundaries of their scotoma(s) on an area-integrating and recording touch flat- screen RGB monitor displaying a central fixation point and movable horizontal/vertical raster lines. The computer calculated summed area of the scotoma(s) with arbitrary scaling from 6000 (dense scotoma) to 0 relative units (absence of scotoma).|12 Months|Eyes of all patients still in the trial were measured|||Units on a scale (0 to 6000)||Standard Error|Mean
1242228|NCT00564902|Secondary|6.5 Degrees Tritan Threshold|The ChromaTest© is a computerized psychophysical test of protan and tritan color thresholds against age-corrected data. The computer finds the endpoint of the test by a Modified Binary Search method; if response is correct, on the next presentation the color difference between letter and background is halved. If response is incorrect, the color -contrast is doubled. Incorrect responses prolong the test, but do not influence the final threshold. This method of determining thresholds leads to finite steps which reach a plateau at the color contrast sensitivity threshold.|12 months|Eyes of all patients still in the trial were measured|||dB||Standard Error|Mean
1242229|NCT00564902|Secondary|Contrast Sensitivity Function Photopic Distance|Distance photopic contrast sensitivity function (CSF) at 5 spatial frequencies (1.5, 3, 6, 12 & 20 cc/deg) was determined with the Functional Vision Analyzer® (Stereo Optical Co, Inc, Chicago, IL). Contrast sensitivity readings are shown as a curve. Visual acuity is plotted along the horizontal axis and contrast sensitivity along the vertical axis. Among the normally sighted people, both visual acuity and contrast sensitivity have a wide range of variation.Low population CSF is 0-200 units; normal population CSF is 200-300 units and suprathreshold CSF is 300+ units.|12 Months|Eyes of all patients still in the trial were measured|||units on a scale||Standard Error|Mean
1242378|NCT00562588|Secondary|Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)|Baseline and 8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||units on a scale||Inter-Quartile Range|Median
1242231|NCT00564902|Secondary|Early Treatment Diabetic Retinopathy Study Distance Visual Acuity|Black and 10% contrast near reading visual acuity was assessed with a Colenbrander Mixed Contrast Reading Card with LogMAR letters (#4031, Precision Vision, LaSalle, Illinois). We determined single letter acuity on an ordinal VAS (Visual Acuity Scale). The largest letters were 0.05 LogMAR with a VAS = 35 while the most difficult smallest letters were LogMar 1.25 or VAS 105. The test card was held at 40 cm with best monocular refraction, and both low and high contrast letter acuity were assessed.|12 months|Eyes of all patients still in the trial were measured|||units on a scale||Standard Error|Mean
1242232|NCT00564902|Secondary|SHAPE Discrimination|We determined the target deformation detection thresholds, or amplitude of the minimum detectable distortion of a 1 degree foveal circular target. The peak spatial frequency of RF (radial frequency) patterns was 5 cyc/deg; the radial modulation frequency was 8 cyc/360°; mean radii were 0.5°, 1°, 2.0°, or 2.5°; and stimulus contrast was 80%. The highest % modulation score possible is 0.13 while the easiest (lowest score) was 10% modulation.|12 months|Eyes of all participants still in the trial were measured|||% modulation||Standard Deviation|Mean
1242233|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).|4 months|All participants in all arms were tested|||Density units of Macular Pigment (du)||Standard Error|Mean
1242234|NCT00564889|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 3 years)||||months||95% Confidence Interval|Median
1242235|NCT00564889|Secondary|Progression Free Survival (PFS)|Progression free survival (PFS) was defined as the time from registration to hematologic progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 3 years)||||months||95% Confidence Interval|Median
1242236|NCT00564889|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, at least possibly related to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Duration of study (up to 3 years)||||participants|||Number
1242237|NCT00564889|Secondary|Number of Patients With Organ Response|"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.~Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%."|Duration of study (up to 3 years)||||participants|||Number
1242238|NCT00564889|Primary|Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)|"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration on study (up to 3 years)||||participants|||Number
1242239|NCT00564876|Secondary|Safety and Tolerability of Adjuvant Dasatinib|Determine the safety and tolerability of adjuvant dasatinib in early stage NSCLC.|Duration of adjuvant treatment plus 30 days.|Due to insufficient accrual, data analysis was not performed.||||||
1242240|NCT00564876|Secondary|Gene Expression Profile Activation of Src Pathways|Determine whether gene expression profile activation of Src pathways is correlated with anti-tumor activity of dasatinib in early stage NSCLC.|Baseline and after 3 weeks of dasatinib therapy at the time of definitive surgical resection.|Due to insufficient accrual, data analysis was not performed.||||||
1242241|NCT00564876|Secondary|Safety and Tolerability of Neoadjuvant Dasatinib|Determine the safety and tolerability of neoadjuvant dasatinib in early stage NSCLC.|Screening / Baseline; Neoadjuvant dasatinib Cycle 1 Day 1 and Day 22|Due to insufficient accrual, data analysis was not performed.||||||
1242242|NCT00564876|Primary|Response Rate|Response rate (radiologic and pathologic) in Stage IB and II to neoadjuvant dasatinib|First progression and survival every 3 months for 2 years, then every 6 months until 5 years, then yearly.|||||||
1242243|NCT00564850|Secondary|Triptorelin Plasma Levels||Month 1, 2, 3, 4, 5 and 6|Analysis was performed on the Pharmacokinetics (PK) Valid population defined as all participants who received at least one injection of 11.25 mg triptorelin pamoate and had at least one PK assessment. 2 participants had data missing at month 1,3 and 6. 1, 3 and 4 participants had data missing at month 2, 4 and 5 respectively.|||ng/mL||Standard Deviation|Mean
1242244|NCT00564850|Secondary|Uterine Length||Month 0, 3 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and 6.|||mm||Standard Deviation|Mean
1242245|NCT00564850|Secondary|Difference Between Bone Age and Chronological Age|Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.|Month 0 and 6|Analysis was performed on the ITT population. 33 participants were assessed. 4 participants had missing data at month 6.|||years||Standard Deviation|Mean
1245558|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
1242246|NCT00564850|Secondary|Change From Baseline in Growth Velocity (GV) SDS at Month 6|"Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.~Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)*365/delay between two height measures."|Baseline and month 6|Analysis was performed on the ITT population. If GV at screening was missing, the value was derived from data recorded between 5 to 19 months ago otherwise GV at screening was considered missing. 9 participants had missing data.|||SD score||Standard Deviation|Mean
1242247|NCT00564850|Secondary|Body Mass Index (BMI) SDS||Month 0, 3 and 6|Analysis was performed on the ITT population. 1 and 2 participants had missing data at month 0 and month 6 respectively.|||SD score||Standard Deviation|Mean
1242248|NCT00564850|Secondary|Height Standard Deviation Score (SDS)|Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.|Month 0, 3 and 6|Analysis was performed on the ITT population. 2 participants had missing data at month 6.|||SD score||Standard Deviation|Mean
1242249|NCT00564850|Secondary|Change From Screening in Pubertal Stage (Tanner Method) at Month 6|Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.|Between screening and month 6|Analysis was performed on the ITT population. 2 participants had missing data for pubic hair stage and breast stage.|||participants|||Number
1242250|NCT00564850|Secondary|Number of Girls With Inhibin B Levels < 6 pg/ml||Month 0, 3 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and month 6.|||participants|||Number
1242251|NCT00564850|Secondary|Testosterone Level||Month 0, 3 and 6|Testosterone level from the male patient in the ITT population.|||ng/ml|||Number
1242252|NCT00564850|Secondary|Number of Girls With Oestradiol Levels ≤ 20 pg/ml||Month 0, 1, 2, 3, 4, 5 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 participant and 3 participants had missing data at month 2 and 5 respectively.|||participants|||Number
1242253|NCT00564850|Secondary|Basal LH Level||Month 0, 1, 2, 3, 4, 5 and 6|Analysis was performed on ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.|||IU/L||Standard Deviation|Mean
1242254|NCT00564850|Secondary|Basal FSH Level||Month 0, 1, 2, 3, 4, 5, and 6|Analysis was performed on the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.|||IU/L||Standard Deviation|Mean
1242255|NCT00564850|Secondary|Follicle Stimulating Hormone (FSH) Level Following GnRH Test||Screening, month 3 and 6|Analysis was performed on the ITT population. 3 participants and 2 participants had missing data at month 3 and month 6 respectively.|||IU/L||Standard Deviation|Mean
1242256|NCT00564850|Secondary|Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L||Month 6|"Analysis was performed on Intention to Treat population (ITT) defined as all participants having received at least one injection of 11.25 mg triptorelin pamoate. n indicates the number of patients who had an assessment at the visit."|||participants|||Number
1242257|NCT00564850|Primary|Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L||3 months after the first injection of triptorelin pamoate 11.25 mg|"Analyses performed on:~Intention to Treat (ITT): all patients having received ≥1 injection. Any subject with missing data is considered a non-responder.~Modified ITT (mITT): all ITT patients with ≥ Month 3 post-baseline assessment of primary efficacy criterion.~Per Protocol (PP): all mITT patients without major protocol deviations."|||participants|||Number
1242258|NCT00564733|Primary|Overall Response Rate (Patients That Achieve a CR or PR)|Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At the end of 4 cycles of treatment, up to 24 weeks.|All patients that signed consent and received at least one cycle of chemotherapy.|||participants|||Number
1242259|NCT00564681|Secondary|Duration of Treatment Effect for Treatment Responders|Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms).|Up to 6 Months|Intent-to-Treat: All enrolled patients|||Days||95% Confidence Interval|Median
1242260|NCT00564681|Secondary|Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1|Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement).|Baseline, Week 4|Intent-to-Treat: All enrolled patients|||Scores on a Scale||Standard Deviation|Mean
1242261|NCT00564681|Secondary|Patient’s Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1|Patient’s global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Intent-to-Treat: All enrolled patients|||Scores on a Scale||Standard Deviation|Mean
1242381|NCT00562588|Secondary|Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)|Baseline and 90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||Units on a scale||Inter-Quartile Range|Median
1242263|NCT00564681|Primary|Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1|Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.|Baseline, Week 4|Intent-To-Treat: All enrolled patients|||Scores on a Scale||Standard Deviation|Mean
1242264|NCT00564629|Secondary|WSTD6|This outcome measure is a statistical analysis of WSTD6, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 6 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-6 hours||||degrees Celsius||Standard Deviation|Mean
1242265|NCT00564629|Secondary|WSTD5|This outcome measure is a statistical analysis of WSTD5, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 5 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-5 hours||||degrees Celsius||Standard Deviation|Mean
1242266|NCT00564629|Secondary|WSTD4|This outcome measure is a statistical analysis of WSTD4, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 4 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-4 hours||||degrees Celsius||Standard Deviation|Mean
1242267|NCT00564629|Secondary|WSTD3|This outcome measure is a statistical analysis of WSTD3, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 3 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-3 hours||||degrees Celsius||Standard Deviation|Mean
1242268|NCT00564629|Secondary|The Percentage of Subjects With Temperature < 38 ºC and < 38.5 ºC at Any Timepoint During the Time From T0 to T360 Minutes|This outcome measures what percentage of total subjects had a temperature < 38 ºC and < 38.5 ºC at any timepoint during the time from T0 to T360 minutes.|T0 to T360 minutes|Analysis performed on mITT population.|||percentage of participants|||Number
1242269|NCT00564629|Secondary|Subject's Global Evaluation of Study Medication at T360 Minutes|"This outcome measures how satisfied the subject was with the study treatment. The subject was asked to answer Overall, how would you rate study treatments? at T360 minutes using a 4-point categorical scale (0=poor, 1=fair, 2=good, 3=excellent)."|T360 minutes|Analysis performed on the mITT population.|||participants|||Number
1242270|NCT00564629|Secondary|Maximum Temperature Reduction Observed From T0 to T360 Minutes|This outcome measures the maximum core temperature reduction observed from T0 to T360 minutes. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|T0-T360 minutes|Analysis performed on the mITT population.|||Degrees Celsius||Standard Deviation|Mean
1242271|NCT00564629|Secondary|Time to a Reduction in Temperature From T0 to T360 Minutes.|This outcome measures how much time it took to observe a decrease in subjects' core body temperature by 0.8 ºC, 1.0 ºC, and 1.5 ºC from the temperature at T0 and from the temperature at the peak after T0 through T360 (6 hours). The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|6 hours|Analysis was performed on the mITT population.|||Hours||Standard Deviation|Mean
1242272|NCT00564629|Primary|The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2)|This outcome measures when the antipyretic effect begins by statistical analysis of WSTD2, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 2 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-2 hours|mITT population defined as all randomized subjects who received at least 1 full dose of oral study medication (subject not vomiting within 2 hours after oral study drug) or 1 full dose of IV study medication(subject having received all 100 mls solution). This analysis was performed with imputation for non-physiological temperature swing zone effect|||Degrees Celsius||Standard Deviation|Mean
1242273|NCT00564486|Secondary|The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event|"The number of subjects who reported at least one treatment emergent SAE during the study.~A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded study medication that:~results in death~is life-threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose to 30 days after last dose of study medication.|All analyses were conducted on the safety population, which included those subjects who received any portion of a dose of study medication.|||Subjects|||Number
1242274|NCT00564486|Secondary|The Number of Subjects Reporting a Treatment Emergent Adverse Event|"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).~A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)."|First dose through 7 day follow up|All analyses of safety were conducted on the safety population, which included those subjects who received any portion of a dose of study medication.|||Subjects|||Number
1242379|NCT00562588|Secondary|Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8|The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||participants|||Number
1242275|NCT00564486|Secondary|Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)|"Sum of Pain Intensity (PI) as measured by the 100 mm long Visual Analogue Scale (VAS) over 24 hours after treatment subtracting the Baseline VAS score.The 100 mm VAS was drawn on a pain ruler and labeled at it's left end with 0 = No Pain' and its right end with '100 = Worst Pain Imaginable.' Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI difference from baseline was calculated at each assessment over a 24 hour period."|Baseline to 24 hrs|Included modified Intent To Treat group (mITT), defined as randomized subjects who received at least one complete infusion of study medication prior to receiving rescue medication.|||Units on a scale||Standard Deviation|Mean
1242276|NCT00564486|Primary|Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)|"Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with 100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period."|Baseline to 24 hrs|All efficacy analyses were conducted using the modified intent-to-treat (mITT) population, defined as those subjects who received at least one complete infusion of study medication prior to requesting rescue medication.Worst Observation Carried Forward (WOCF) imputation was applied after first rescue medication.|||Units on a scale||Standard Deviation|Mean
1242277|NCT00564447|Primary|Assessment of Pharmacokinetic Parameters|Conjunctiva Concentration of Azithromycin and Moxifloxacin|Over 24 hours||||μg/g||Standard Deviation|Mean
1242278|NCT00564447|Primary|Assessment of Pharmacokinetic Parameters||Up to 24 hours|||||||
1242279|NCT00564395|Primary|Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections|Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections.|0-48 hours post-dose||||mmol*hr/L||Standard Deviation|Mean
1242280|NCT00564278|Secondary|Proportion of Fully Adherent Days|We used the Composite Adherence Score (CAS) described in our grant application to calculate medication adherence levels from all data sources (electronic caps [eCaps], pill count, self-report) and compare these across arms. Calculated via a statistically calibrated algorithm, the CAS relied first on eCaps data, secondarily on pill count, and the adherence questionnaire if eCaps data was missing due to an eCap malfunction. We calculated the number of the days the patient was fully adherent, number of days of partial adherence (e.g., opened the eCap fewer times than prescribed), or number of days of nonadherence when they did not take any prescribed pills. Patients who dropped out of the study and provided no further follow-up data were considered nonadherent for the remainder of the study period. We calculated the therapy-adherent period as a proportion of the total intended treatment period or proportion of days of full adherence, # of fully adherent days / # of days in treatment.|Measured at each visit, up to 36 weeks|All patients in both arms|||Proportion of Fully Adherent days||Standard Deviation|Mean
1242281|NCT00564278|Secondary|Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)|Patient satisfaction was assessed using the 8-item Client Satisfaction Questionnaire (CSQ) which assesses patients' satisfaction with the services received. CSQ total score ranges from 8-32 with higher scores indicating greater satisfaction. The CSQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the CSQ over 36 weeks using repeated measures.|CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.|||units on a scale ranging from 8 to 32||Standard Deviation|Mean
1242282|NCT00564278|Primary|Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|Quality of life was assessed using the 16-item Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ), a self-reported measure of quality of life in 8 domains that is sensitive to depressive symptom severity and treatment response. We analyzed the QLESQ total score as a percentage of the maximum possible score (ranging from 0-100) to facilitate comparisons across areas of functioning. It was calculated as such: % Max = (Raw score - minimum possible score) / (maximum possible score-minimum possible score) where raw score is the sum of the first 14 items. Higher numbers indicate better quality of life, greater enjoyment, and satisfaction. The QLESQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the QLESQ over 36 weeks using repeated measures.|QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.|||percentage of maximum possible score||Standard Deviation|Mean
1242283|NCT00564278|Primary|Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)|Psychosocial functioning was assessed using the Sheehan Disability Scale (SDS), a self-report instrument composed of three visual analog subscales assessing degree of disruption caused by symptoms in three domains: work, social/leisure activities, and family/home life. We analyzed the 3 subscale scores for the 3 domains separately which ranged from 0 to 10 with higher scores indicating worse functioning. The SDS was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the SDS over 36 weeks using repeated measures.|SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.|||Units on a scale ranging from 0-10||Standard Deviation|Mean
1242284|NCT00564278|Primary|Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)|"Depressive symptoms were assessed using the 17-item standard clinician-administered version of the Hamilton Depression Scale (HAMD-17). We analyzed the HAMD-17 score, calculated as the sum of the individual items and ranging from 0 to 35 with higher numbers indicating more symptoms. HAMD-17 was assessed at baseline and the follow-up visits specified below.~We calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures."|HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|All patients enrolled in both arms with available data at assessment time points.|||units on a scale ranging from 0 to 35||Standard Deviation|Mean
1242285|NCT00564278|Primary|Number of Days in ADT (Retention)|A continuous measure of the total number of days in treatment, based on visit attendance. At each kept visit, patients will be credited as having been in treatment for the number of days since their last scheduled visit. For example, patients attending sessions on weeks 0, 1, and 12 would have been in treatment for 35 days (7 [week 0 to week 1] + 28 [week 8 to week 12]).|Measured at Months 3 and 9|Patients who signed consent and attended at least one medication visit.|||Days in treatment||Standard Deviation|Mean
1242286|NCT00564265|Primary|Number of Patients Who Survived|The outcomes were measured through follow-up visits of the patients to the out-patient clinic of our institution at 15 days, 1 month, 3 months, 6 months, 1 year, and after that, every year after the surgical treatment.|5 years|This is a consecutive sample of all patients operated on for GISTs in 3 hospitals during a period of 5 years. The period of 5 years was determined by the time that we count with inmunochemistry to confirm GISTs at our institutions, and that time would be the last 5 years. The Last Observation Carried Dorward (LOCF) was made in August 2008.|||Participants|||Number
1242287|NCT00564070|Other Pre-specified|Glucose Control Over Follow up|Percent of HbA1c as assessed by blood analysis. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage. This percentage of HbA1c was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of HbA1c for each arm throughout the course of the study.|Aggregate across 4,8,12 months|HbA1c as assessed by blood analysis|||percentage of glycosylated hemoglobin||Standard Error|Mean
1242288|NCT00564070|Other Pre-specified|Depression CGI|Clinical Global Impression scale as rated by blinded interviewer. The CGI is a scale from 1-7 with greater numbers meaning more severe depression. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study.|Aggregate 4,8,12 months||||Units on the CGI scle||Standard Error|Mean
1242289|NCT00564070|Other Pre-specified|Depression MADRS Over Follow up|Independent (blind) assessor rating using the MADRS. This scale has a range of 0-60 with higher scores indicating greater depression severity. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study.|Aggregate across 4,8,12 months||||Units on the MADRS scale||Standard Error|Mean
1242290|NCT00564070|Other Pre-specified|Percent Medication Adherence During Follow up|Electronic pill cap adherence which indicates a percentage of doses taken. This percentage of doses taken was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of doses taken for each arm throughout the course of the study.|Aggregate across 4,8,12 months||||percentage of doses taken||Standard Error|Mean
1242291|NCT00564070|Other Pre-specified|Glucose Monitoring During Followup.|This is a percent with a possible range of 0-100 with higher scores indicating better adherence. One Touch Ultra meters (LifeScan, Inc.) for daily glucose control provided frequency of self-monitoring, which when divided by the individualized goals from the nurse visits and multiplied by 100, yielded a percentage adherence score. This percentage adherence score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage adherence score for each arm throughout the course of the study.|Aggregate of months 4,8,12||||percentage of glucose monitoring goal||Standard Error|Mean
1242292|NCT00564070|Primary|Depression on the CGI at Acute Outcome|Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression|Month 4|Participants in each study arm|||units on a scale - the CGI||Standard Deviation|Mean
1242293|NCT00564070|Primary|Clinician Rated Depression (MADRS) at the Acute Timepoint|Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity.|month 4|Participants in each arm|||units on a scale (MADRS)||Standard Deviation|Mean
1242294|NCT00564070|Primary|Percent Medication Adherence Via MEMS|This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence|month 4|Participants in each study arm|||Percentage of pills taken||Standard Deviation|Mean
1242295|NCT00564070|Secondary|Glucose Control|Hemoglobin A1C value at acute outcome. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage.|Month 4|HbA1c as assessed by blood analysis|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1242296|NCT00564070|Primary|Glucose Monitoring Adherence at Acute Outcome|Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence.|Measured at Month 4||||percentage of glucose monitoring goal||Standard Deviation|Mean
1242297|NCT00563797|Secondary|Mean Percentage of Heavy Drinking Days by Smoking|The two-way interaction between medication by smoking status to measure percentage of heavy drinking days measured by time line follow back survey. Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) over the number of days in the study for smokers and non smokers receiving either mecamylamine or placebo.|25 weeks||||percentage of Heavy Drinking Days||Standard Deviation|Mean
1242298|NCT00563797|Secondary|Mean Percentage of Number of Drinking Days by Smoking Status|Two-way interaction between smoking and medication for percentage of drinking days captured by time line follow back surveys. Data are calculated as number of drinking days over the number of days in the study for smokers and nonsmokers receiving either mecamylamine or placebo.|25 weeks||||Percentage of Drinking Days||Standard Deviation|Mean
1242299|NCT00563797|Primary|Depression - Measured Using the HAMD Total Score|"The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient’s level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients.~Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to >23 (Very Severe Depression)"|12 weeks||||units on a scale||Standard Deviation|Mean
1242300|NCT00563797|Primary|Number of Drinking Days|Measured with time line follow back measures|25 weeks||||days||Standard Deviation|Mean
1242467|NCT00561977|Secondary|Change in Weight From Baseline to 3 Months||3 months||||pounds||Standard Deviation|Mean
1242301|NCT00563706|Secondary|Calgary Depression Scale for Schizophrenia (CDSS) Score|CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
1242302|NCT00563706|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale to assess global improvement in the participant’s clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).|Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
1242303|NCT00563706|Secondary|Clinical Global Impression - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
1242304|NCT00563706|Secondary|Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score|Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
1242305|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score|Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
1242306|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score|General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
1242307|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Negative Subscale Score|PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
1242308|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Positive Subscale Score|PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
1242309|NCT00563706|Primary|Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Day 28|mITT population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1242324|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 7|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242310|NCT00563706|Primary|Positive and Negative Symptom Scale (PANSS) Total Score at Baseline|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score.|||units on a scale||Standard Deviation|Mean
1242311|NCT00563576|Secondary|Percentage of Subjects Who Receive a 3rd Injection||6 months|||||||
1242312|NCT00563576|Secondary|Number of Subjects Who Receive a 2nd Injection of Depo-Provera||3 months||||participants|||Number
1242313|NCT00563576|Secondary|Percentage of Users Who Were Satisfied With Femring|Acceptability was measured using questionnaires that assessed satisfaction of Femring and usage of the ring. This outcome was only measured among the intervention group of women who actually were randomized to use of Femring. Acceptability of the vaginal ring was high among those in the intervention group.|3 months|Acceptability was reported among the 26 participants in the Femring group who were available for followup, i.e., per protocol.|||participants|||Number
1242314|NCT00563576|Primary|Mean Number of Bleeding or Spotting Days|Bleeding and spotting were defined using World Health Organization criteria and measured through daily diaries given to participants and collected at the 3 and 6 month followup. In addition, a study staff member called participants weekly to collect the daily bleeding and spotting calendar for that week to optimize the accuracy of this information.|3 months||||days||Standard Deviation|Mean
1242315|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 16|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242316|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 15|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242317|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 14|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242318|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 13|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242319|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 12|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242320|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 11|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242321|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 10|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242322|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 9|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242323|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 8|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242374|NCT00562588|Secondary|Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8|MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).|Baseline and day 8|Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 8.|||mL||Inter-Quartile Range|Median
1242325|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 6|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242326|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 5|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242327|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 4|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242328|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 3|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242329|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 2|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242330|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 1|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
1242331|NCT00563381|Secondary|COPD Exacerbations Treated With Systemic Steroids and Antibiotics Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||exacerbations per patient-year||95% Confidence Interval|Mean
1242332|NCT00563381|Secondary|COPD Exacerbations Treated With Antibiotics Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||exacerbations per patient-year||95% Confidence Interval|Mean
1242333|NCT00563381|Secondary|COPD Exacerbations Treated With Systemic Steroids Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||exacerbations per patient-year||95% Confidence Interval|Mean
1242334|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Systemic Steroids and Antibiotics|First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
1242335|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Antibiotics|First occurrence analysed by Cox regression as time to first exacerbation treated with antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
1242336|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Systemic Steroids|First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
1242337|NCT00563381|Secondary|First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First|First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
1242338|NCT00563381|Secondary|Number of Participants With Premature Discontinuation of Trial Medication||52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||Participants|||Number
1242339|NCT00563381|Secondary|Occurrence of Premature Discontinuation of Trial Medication|Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
1242340|NCT00563381|Secondary|Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||Participants|||Number
1242341|NCT00563381|Secondary|First Occurrence of COPD Exacerbation Leading to Hospitalization|First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
1242342|NCT00563381|Secondary|COPD Exacerbations Per Patient-year||52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||exacerbations per patient-year||95% Confidence Interval|Mean
1242343|NCT00563381|Secondary|Number of Participants With at Least One COPD Exacerbation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||Participants|||Number
1242344|NCT00563381|Secondary|COPD Exacerbations Per Patient-year Leading to Hospitalisation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||Hospitalizations per patient-year||95% Confidence Interval|Mean
1242345|NCT00563381|Primary|First Occurrence of (Moderate or Severe) COPD Exacerbation|First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
1242346|NCT00563368|Primary|Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF||baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percentage of participants|||Number
1242347|NCT00563368|Primary|Percent Weight Loss From Baseline to Week 28|Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)|baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
1242348|NCT00563316|Primary|Number of Participants With Clinically Significant Adverse Events (AEs)|"Adverse events of special interest include infusion reactions, integument toxicities, diarrhea, stomatitis, hypomagnesemia, and pulmonary, vascular, and cardiac toxicities. Infusion reactions were defined as 1. Prespecified signs and symptoms indicating a possible infusion reaction (derived from Common Terminology Criteria for Adverse Events (CTCAE) definitions of allergic reaction/hypersensitivity and cytokine release syndrome/acute infusion reaction) with onset day coincident with any study drug infusion and which resolved the day of, or the day after, onset; 2. incidence of AE with terms consistent with the panitumumab US package insert (USPI) (any event within 24 hours of an infusion during the clinical study described as allergic reaction or anaphylactoid reaction, or any event occurring on the first day of dosing described as allergic reaction, anaphylactoid reaction, fever, chills, or dyspnea).~Data are summarized overall and by treatment phase."|The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date, until the data cut-off date of 16 July 2009. The median time frame is 5.7 months.|All treated participants|||participants|||Number
1242349|NCT00563316|Primary|Area Under the Plasma Concentration-time Curve From the Time of the Last Quantifiable Concentration (AUClast) for Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the AUClast of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set|||hr*ng/mL||Standard Deviation|Mean
1242350|NCT00563316|Primary|Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUCinf) for Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the AUCinf of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set|||hr*ng/mL||Standard Deviation|Mean
1242351|NCT00563316|Primary|Maximum Observed Plasma Concentration (Cmax) of Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the Cmax of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured. Plasma samples were assayed by a validated high performance liquid chromatography (HPLC)-fluorescence method for the measurement of irinotecan. The lower limit of quantitation (LLOQ) was 2 ng/mL.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set included all participants who received panitumumab 6 mg/kg and irinotecan 180 mg/m² without dose reductions or delays and who completed the blood sample collection for pharmacokinetic analysis during cycles 1 and 2.|||ng/mL||Standard Deviation|Mean
1242352|NCT00563290|Secondary|COX-2 Presence by IHC|Performed per standard protocols by the Pathology Department. Samples will be obtained pre-therapy. Determination of the COX-2 tumor status on this trial will develop the beginnings of a data base upon which future therapy may be designed.|At baseline|Funding was not available to do correlative studies||||||
1242353|NCT00563290|Secondary|Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)|Performed per standard protocols by the Pathology Department.|At baseline|Funding was not available to do correlative studies||||||
1242354|NCT00563290|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Time from start of treatment to time of progression, assessed up to 12 weeks|The second treatment arm of Dasatinib 70 mg orally twice a day was created as a result of an amendment to the protocol therefore the patient PFS data was combined for each arm.|||weeks||Full Range|Median
1242355|NCT00563290|Primary|Objective Response Rate (Complete Response and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment||||percentage of patients|||Number
1242356|NCT00563186|Post-Hoc|Event Incidence Density in Single vs Multi-bed Rooms in Novel Design Ward Only|The incidence density of MRSA, VRE and CDI occurring in single-bed vs. multi-bed rooms was examined on only the novel design ward|In-hospital|All patients that met the inclusion and exclusion categories and were admitted to the novel design ward were assessed for the development of MRSA, VRE or CDI. The incidence densities in single-bed rooms were then compared to the incidence densities in multiple-bed rooms.|||events per 1000 patient days|||Number
1242357|NCT00563186|Secondary|Number of MRSA, VRE and CDI Occurring in Single-bed Rooms vs. Multiple Bed Rooms AND Occurring in Outbreaks Related to the Primary Case|If a patient is swabbed and found to be positive (for MRSA or VRE), their current roommate\roommates will be swabbed (if in the same room > 48 hrs) as well as any other patient that shared a room with this patient for > 48 hours during this stay. Any patient who may have shared a bathroom with the first patient would also be swabbed. If the results from this investigation showed any positive roommates, then the process would repeat for each positive patient. Then, in consult with the infectious disease physician, a call will be made regarding a point prevalence study to determine the attack rate\burden of disease on the unit.|in-hospital|An outbreak occurred when more than 1 case of MRSA, VRE or CDI was epidemiologically linked to a primary case. In total 22 outbreak cases were detected during the study. The location of these outbreak cases (single-bed rooms vs. multi-bed rooms) was identified in the Novel Hospital Ward and the Traditional Hospital Ward|||outbeak infections/colonizations|Total Number of Outbreak cases||Number
1242358|NCT00563186|Primary|Incidence Density of Hospital-acquired Infection With Clostridium Difficile (CDI), and Hospital-acquired Infection or Colonization With Vancomycin-resistant Enterococcus (VRE), or Methicillin-resistant Staphylococcus Aureus (MRSA).||participants were followed for the duration of hospital stay, an average of 10 days|All patients meeting inclusion criteria, and admitted to the General Internal Medicine (GIM) service on the novel infection control design ward or the traditional infection control design ward were followed for the development of MRSA or VRE infection (inf) or colonization (col) or CDI after 48 hours of admission|||events per 1000 patient days|||Number
1242359|NCT00562965|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Criteria for determining significant change from baseline in vital signs abnormalities: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, and body weight>=10% increase or decrease of body weight in kilogram (kg).|Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)|Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).|||participants|||Number
1242360|NCT00562965|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings|Criteria for laboratory test abnormality: Blood Chemistry (alkaline phosphatase [greater than{>}5*upper limit of normal {ULN}, calcium [less than {<}1.75 millimole per liter {mmol/L}, creatinine [>3*ULN], glucose [>13.9 mmol/L], phosphorous [<0.6 mmol/L], potassium [<3 mmol/L], aspartate transaminase [>5.0*ULN], total bilirubin [>3*ULN]), Coagulation (international normalized ratio [>2*ULN]), Hematology (hemoglobin [<80 grams/Liter], lymphocytes [<0.5*10^9/L], absolute neutrophil count [<1*10^9/L], platelet count [<50*10^9/L], WBC [<2.0*10^9/L]).|Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)|Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).|||participants|||Number
1242361|NCT00562965|Other Pre-specified|Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)|AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. TEAE=between first dose of study drug and up to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 42 days post-treatment|Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).|||participants|||Number
1242362|NCT00562965|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings|Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment.|Baseline up to 42 days post-treatment|Safety population included all participants who received at least 1 dose of a test article. Here 'N' signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1242363|NCT00562965|Secondary|Pharmacokinetics of Inotuzumab Ozogamicin in Combination With Rituximab||0, 1, 168 hours on Cycle 1, 2; 0, 1, 2, 168 hours on Cycle 3, 4|Data for this outcome measurement was not collected since pharmacokinetic parameters were not analyzed in this study due to very few number of participants with PK samples.||||||
1242364|NCT00562965|Secondary|Overall Survival Probability at Months 6, 12 and 24|Overall survival was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. Participants who withdrew or lost to follow-up from study without having death documented were censored at the date of last contact. Kaplan-Meier estimates of the probability of survival at 6, 12 and 24 months was used to estimate the survival function.|Baseline up to Month 6, 12, 24|Intent-to-treat population included all participants who were randomized in to the study.|||percent chance of survival||95% Confidence Interval|Number
1242365|NCT00562965|Secondary|Percentage of Participants With Objective Response (OR)|OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin’s Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size [at least 1.5 centimeter(cm) or less],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia).|Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug|Intent-to-treat population included all participants who were randomized in to the study.|||percentage of participants||95% Confidence Interval|Number
1242366|NCT00562965|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44.|Baseline until disease progression or death or up to 1 year after last dose of study drug|Intent-to-treat population included all participants who were randomized in to the study.|||months||95% Confidence Interval|Median
1242367|NCT00562861|Primary|MADRS Rating Scale Change|Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.|6 weeks|All patients randomized were analyzed in intent to treat manner.|||units on a scale||Standard Deviation|Mean
1242368|NCT00562627|Secondary|Time to Readiness for Discharge|Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.|up to 10 days postoperative||||days||Standard Deviation|Mean
1242369|NCT00562627|Primary|Pain at Rest (VAS)|VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.|48 hours postoperative||||Units on a scale||Standard Deviation|Mean
1242370|NCT00562627|Secondary|Opioid Use|Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.|48 hours postoperative||||mg||Standard Deviation|Mean
1242371|NCT00562588|Secondary|Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90|MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.|Baseline and day 90|Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 90.|||mL||Inter-Quartile Range|Median
1242372|NCT00562588|Secondary|Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8|MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.|Baseline and day 8|Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 8.|||mL||Inter-Quartile Range|Median
1242373|NCT00562588|Secondary|Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.|MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).|Baseline and day 90|Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 90.|||mL||Inter-Quartile Range|Median
1242382|NCT00562588|Primary|Telephone Modified Rankin Scale (Centralised, Blinded Assessment)|The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)|90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||participants|||Number
1242383|NCT00562484|Secondary|New Onsets of Chronic Illness (NOCI)|An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.|||Participants|||Number
1242384|NCT00562484|Secondary|Serious Adverse Events (SAEs)|"An SAE was any untoward medical occurrence that at any dose:~Resulted in death;~Was life-threatening;~Required an unexpected in-participant hospitalization or prolongation of existing hospitalization;~Resulted in persistent or significant disability / incapacity;~Was a congenital anomaly / birth defect; and / or~Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out"|180 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.|||Participants|||Number
1242385|NCT00562484|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|"UAE grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities."|21 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.|||Participants|||Number
1242386|NCT00562484|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms|"Adverse event grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities.~Fever Grade 1: ≥ 37.7°C - < 38.0°C (≥ 99.9 - < 100.4°F) Grade 2: ≥ 38.0°C - < 39.0°C (≥ 100.4 - < 102.2°F) Grade 3: ≥ 39.0°C (> 102.2°F)"|5 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL’s IVV or placebo) and provided at least one safety assessment after the vaccination.|||Participants|||Number
1242387|NCT00562484|Secondary|Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009|Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Fold increase||95% Confidence Interval|Number
1242388|NCT00562484|Secondary|Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008|Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Fold increase||95% Confidence Interval|Number
1242389|NCT00562484|Secondary|Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009|Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants||95% Confidence Interval|Number
1242390|NCT00562484|Secondary|Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008|Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants||95% Confidence Interval|Number
1242391|NCT00562484|Secondary|Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009||21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants||95% Confidence Interval|Number
1242392|NCT00562484|Secondary|Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008||21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants||95% Confidence Interval|Number
1245559|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population||Week 52|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1242393|NCT00562484|Secondary|Incidence of Influenza-like Illness (ILI)|"The criteria for the protocol defined ILI were as follows:~At least one respiratory symptom:~cough, sore throat or nasal congestion~And at least one systemic symptom:~fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant’s subjective feeling of fever), chills or body aches.~The CDC ILI case definition was the occurrence of fever (100°F [37.8°C] or higher) in conjunction with either cough or sore throat."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants|||Number
1242394|NCT00562484|Secondary|CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains|"Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.~Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Ratio||95% Confidence Interval|Number
1242395|NCT00562484|Primary|CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection|"Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.~Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Ratio||95% Confidence Interval|Number
1242396|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1242397|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population|Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1242398|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1242399|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1242400|NCT00562354|Secondary|Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.|||fold rise||95% Confidence Interval|Geometric Mean
1242401|NCT00562354|Secondary|Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.|||fold rise||95% Confidence Interval|Geometric Mean
1242402|NCT00562354|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate antibody concentration for the specified serotype. GMCs calculated using all participants with available data for the specified blood draw.|||mcg/mL||95% Confidence Interval|Geometric Mean
1242403|NCT00562354|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
1242404|NCT00562354|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
1242405|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1242406|NCT00562354|Secondary|Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1242407|NCT00562354|Secondary|Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1242408|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1242409|NCT00562354|Secondary|Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1245560|NCT00541658|Secondary|Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population||Week 26|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1242410|NCT00562354|Secondary|Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1242411|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1242412|NCT00562354|Secondary|Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1242413|NCT00562354|Secondary|Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1242414|NCT00562354|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate antibody titers for the specified serotype. GMTs calculated using all participants with available data for the specified blood draw.|||titer||95% Confidence Interval|Geometric Mean
1242415|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination (Day 1), 1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.|||fold rise||95% Confidence Interval|Geometric Mean
1242416|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination (Day 1), 1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.|||fold rise||95% Confidence Interval|Geometric Mean
1242417|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.|||titer||95% Confidence Interval|Geometric Mean
1242468|NCT00561977|Primary|Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).|The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0–10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).|3 months||||score||Standard Deviation|Mean
1242418|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.|||titer||95% Confidence Interval|Geometric Mean
1242419|NCT00562328|Secondary|Time to Subsequent Therapy|Time to subsequent treatment (TTS) was defined as the time from end of active (protocol) treatment to the start of subsequent treatment. The median TTS with 95% CI was estimated using the Kaplan Meier method.|time from end of protocol treatment to subsequent treatment (up to 5 years)|||||||
1242420|NCT00562328|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 5 years)|||||||
1242421|NCT00562328|Secondary|Duration of Response|Duration of response (DOR) is defined as the time from documentation of response (CR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method.|time from start of response to progression (up to 5 years)|||||||
1242422|NCT00562328|Secondary|Time to Response|Time to response (TTR) is defined as the time from registration to first documentation of response (CR or PR). In participants who do not achieve a response, time will be censored at the participants last evaluation (for disease) date. The median TTR with 95% CI was estimated using the Kaplan Meier method.|time from registration to first documentation of response (up to 5 years)|||||||
1242423|NCT00562328|Secondary|Time to Disease Progression|Time to disease progression (TTP) was defined as the time from registration to the earliest date documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Time from registration to progression (up to 5 years)|||||||
1242424|NCT00562328|Primary|Proportion of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months|"Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months:~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|6 months||||participants|||Number
1242425|NCT00562315|Secondary|Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma|"Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]~Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed~Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed"|Up to 5 years|Participants with a definitive consensus for the presence or absence of extraprostatic disease.|||percentage of true tests||95% Confidence Interval|Number
1242426|NCT00562315|Secondary|Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed|"Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)~Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed~Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed"|Up to 5 years|Participants with a definitive consensus on the presence or absence of prostatic/bed disease.|||percentage of true tests||95% Confidence Interval|Number
1242427|NCT00562315|Primary|Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed|"Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)~Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed~Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed"|Up to 5 years|Participants with a definitive consensus on the presence or absence of prostatic/bed disease.|||percentage of true tests||95% Confidence Interval|Number
1245561|NCT00541658|Secondary|Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population||Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1242428|NCT00562315|Primary|Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma|"Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]~Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed~Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed"|Up to 5 years|Participants with a definitive consensus for the presence or absence of extraprostatic disease.|||percentage of true tests||95% Confidence Interval|Number
1242429|NCT00562315|Primary|Number of Participants With False Negative Scans Outside the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.|||participants|||Number
1242430|NCT00562315|Primary|Number of Participants With False Positive Scans Outside the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.|||participants|||Number
1242431|NCT00562315|Primary|Number of Participants With True Negative Scans Outside the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.|||participants|||Number
1242432|NCT00562315|Primary|Number of Participants With True Positive Scans Outside the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.|||participants|||Number
1242433|NCT00562315|Primary|Number of Participants With False Negative Scans Within the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.|||participants|||Number
1242434|NCT00562315|Primary|Number of Participants With True Negative Scans Within the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.|||participants|||Number
1242435|NCT00562315|Primary|Number of Participants With False Positive Scans Within the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.|||participants|||Number
1242436|NCT00562315|Primary|Number of Participants With True Positive Scans Within the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.|||participants|||Number
1242437|NCT00562302|Secondary|Incidence of Adverse Events|Any treatment emergent adverse events (not considered device related by the investigators).|30 days|Intent to Treat Population|||participants|||Number
1242438|NCT00562302|Secondary|Participants Discharged Beyond Hospital's Standard of Care|Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital’s standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care.|30-day|Intent to Treat Population|||participants|||Number
1242439|NCT00562302|Secondary|Number of Participants With Additional Chest X-rays Needed||30 day|Intent to Treat Population|||participants|||Number
1242440|NCT00562302|Secondary|Incidence of Adverse Events Related to the Procedure and Device Effects|Anticipated, device-related adverse events that were defined in the original protocol.|30 Day|Intent to Treat Patients|||participants|||Number
1242441|NCT00562302|Secondary|Incidence of Hospital Admissions for Pneumothorax||30 day|Intent to treat Population|||participants|||Number
1242442|NCT00562302|Secondary|Time to Ambulation||30 days|Intent to Treat Population|||Hours||Standard Deviation|Mean
1242443|NCT00562302|Secondary|Incidence of Chest Tube Placement|A chest tube is the definitive initial treatment of a pneumothorax.|30 days|Intent to treat Population|||participants|||Number
1242444|NCT00562302|Primary|Incidence Rate of Treatment Success|Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).|30 days|Per Protocol Population|||participants|||Number
1242445|NCT00562159|Secondary|Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS|The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Deviation|Mean
1242446|NCT00562159|Secondary|Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS|The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
1242447|NCT00562159|Secondary|Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS|The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
1242448|NCT00562159|Primary|Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)|The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication.|Start of the GPS to End of the GPS|The full analysis set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
1242449|NCT00562120|Other Pre-specified|Serum PF-03654746 Concentration|Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.|1 hr 30 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1242450|NCT00562120|Secondary|Nasal Symptom Scores: Sneezing|The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where ‘post-diluent, pre-allergen challenge’ included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and ‘post-allergen challenge’ included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||sneezes||Standard Deviation|Mean
1242451|NCT00562120|Secondary|Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea|Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for ‘post-diluent, pre-allergen challenge’ measure and ‘post-challenge’ measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||units on a scale||Standard Deviation|Mean
1242452|NCT00562120|Secondary|Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume ‘post-allergen challenge’ measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest ‘post-allergen challenge’ nasal volume measurement among the 3 measures.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||cubic centimeter (cm^3)||Standard Deviation|Mean
1242469|NCT00561977|Primary|Dietary Quality|Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).|6 mos||||score||Standard Deviation|Mean
1242470|NCT00561951|Secondary|The Number of Patients With “Severe Problems, Score 5” or “Many Severe Problems, Score 6” in Patient Perception of Bladder Condition (PPBC) at Week 12.|"Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:~No problems at all~Some very minor problems~Some minor problems~Some moderate problems~Severe problems~Many severe problems"|Baseline to Week 12|Full analysis set. No imputation was used for missing data|||participants|||Number
1243196|NCT00557505|Other Pre-specified|Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood||Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal|Data was not analyzed, as development of the compound was terminated.|||cells/mL|||Number
1242453|NCT00562120|Secondary|Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin ‘post-allergen challenge’ measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest ‘post-allergen challenge’ Amin measurement of the 3 measures.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||square centimeter (cm^2)||Standard Deviation|Mean
1242454|NCT00562120|Primary|Nasal Volume Proportion Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume ‘post-allergen challenge’ measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single ‘post-allergen challenge’ value. Nasal volume proportion was defined as ratio of ‘post-allergen challenge’ value and ‘Baseline/pre-allergen challenge value’. Diluent used was saline and allergen was short ragweed extract.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||ratio||Standard Deviation|Mean
1242455|NCT00562120|Primary|Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin ‘post-allergen challenge’ measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single ‘post-allergen challenge’ value. Amin proportion was defined as ratio of ‘post-allergen challenge’ value and ‘Baseline/pre-allergen challenge value’. Diluent used was saline and allergen was short ragweed extract.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||ratio||Standard Deviation|Mean
1242456|NCT00562094|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|last visit (after a median of 18 days)|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
1242457|NCT00562094|Secondary|Assessment of the Efficacy of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|last visit (after a median of 18 days)|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
1242458|NCT00562094|Secondary|Assessment of the Severity of Sensation of Fullness/Abdominal Distension|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1242459|NCT00562094|Secondary|Assessment of the Severity of Epigastric Complaints/Epigastric Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1242460|NCT00562094|Secondary|Assessment of the Severity of Eructation/Acid Eructation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1242461|NCT00562094|Secondary|Assessment of the Severity of Heartburn|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1242462|NCT00562094|Primary|Assessment of Change of Quality of Sleep During Therapy With Pantoprazole|"Physician's assessment on a scale with~considerably improved~improved~unchanged"|last visit (after a median of 18 days)|All patients included and treated, intention to treat, missing values not imputed|||percentage of participants|||Number
1242463|NCT00562094|Primary|Assessment of the Severity of Sleep Disturbances|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|All patients included and treated, intention to treat, missing values not imputed|||percentage of participants|||Number
1242464|NCT00561977|Secondary|Change in Calories From Baseline to 6 Months|kilocalories|6 months||||calories||Standard Deviation|Mean
1242465|NCT00561977|Secondary|Change in Calories From Baseline to 3 Months|kilocalories|3 months||||calories||Standard Deviation|Mean
1242466|NCT00561977|Secondary|Change in Weight From Baseline to 6 Months||6 months||||pounds||Standard Deviation|Mean
1242471|NCT00561951|Secondary|Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.|"Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:~No problems at all~Some very minor problems~Some minor problems~Some moderate problems~Severe problems~Many severe problems~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. No imputation was used for missing data.|||score on scale||Standard Deviation|Mean
1242472|NCT00561951|Secondary|Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.|"The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).~The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)|||score on scale||Standard Deviation|Mean
1242473|NCT00561951|Secondary|Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).|"King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week12|Full analysis set. No imputation was used for missing data.|||score on scale||Standard Deviation|Mean
1242474|NCT00561951|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||mL||Standard Deviation|Mean
1242475|NCT00561951|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 12.|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.|||mL||Standard Deviation|Mean
1242476|NCT00561951|Secondary|Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|"Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set.~No imputation was used for missing data."|||Night-Time Micturitions||Standard Deviation|Mean
1242477|NCT00561951|Secondary|Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.|"Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|"Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline .~Last observation carried forward."|||Night-Time Micturitions||95% Confidence Interval|Least Squares Mean
1242478|NCT00561951|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Incontinence is the complaint of any involuntary leakage of urine.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||Incontinence Episodes||Standard Deviation|Mean
1242479|NCT00561951|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.|"Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Incontinence is the complaint of any involuntary leakage of urine.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward|||Incontinence Episodes||95% Confidence Interval|Least Squares Mean
1242480|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||Urgency Episodes||Standard Deviation|Mean
1242481|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.|"Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.|||Urgency Episodes||95% Confidence Interval|Least Squares Mean
1242482|NCT00561951|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||Micturitions||Standard Deviation|Mean
1242483|NCT00561951|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.|"Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.|||Micturitions||95% Confidence Interval|Least Squares Mean
1242521|NCT00561795|Secondary|18-week Progression Free Survival|Defined as the number participants who have not had radiological disease progression per RECIST, confirmed CA-125 progression, or death due to any cause by the end of 18 weeks.|Baseline to Week 18||||participants|||Number
1242484|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||UUI Episodes||Standard Deviation|Mean
1242485|NCT00561951|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.|"Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.|||UUI Episodes||95% Confidence Interval|Least Squares Mean
1242486|NCT00561925|Secondary|Occurrence of Hepatic Events|Frequency of patients with hepatitis symptoms|until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
1242487|NCT00561925|Secondary|Relative Bioavailability Trough C_pre,ss,1|Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.|week 132|Only patients with trough drawn PK time window (12+/-2.5 hr for IR; 24+/-5hr for XR) at week 132 are included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1242488|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose|||cumulative probability|||Number
1242489|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose|||cumulative probability|||Number
1242490|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose|||cumulative probability|||Number
1242491|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose|||cumulative probability|||Number
1242492|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||cumulative probability|||Number
1242493|NCT00561925|Secondary|Occurrence of Elevations in Laboratory Measurement by DAIDS Grade||until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
1242494|NCT00561925|Secondary|Occurrence of Rashes|Frequency of patients with drug related rash events by functional grouping|until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
1242495|NCT00561925|Secondary|Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases|||cells/cubic millimeter||Standard Deviation|Mean
1242496|NCT00561925|Secondary|Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases|||log10 copies/mL||Standard Deviation|Mean
1242497|NCT00561925|Secondary|Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||proportion of participants|||Number
1242498|NCT00561925|Secondary|Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
1242499|NCT00561925|Secondary|Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||proportion of participants|||Number
1242500|NCT00561925|Primary|Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL|week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
1242501|NCT00561912|Primary|Progression-free Survival (PFS) Times|Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.|From treatment start or until disease progression or death for any reason, at least 16 weeks|With one of the two participants ruled ineligible and inevaluable, there was insufficient data for statistical evaluation.|||Weeks|||Number
1242502|NCT00561834|Primary|Change in Visual Acuity|The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab.|Baseline and 6 months||||lines change in Snellen chart|||Number
1242503|NCT00561821|Secondary|Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period|An AE is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.|Up to Day 16|All participants who received at least one dose of study medication.|||Number of participants|||Number
1242504|NCT00561821|Secondary|Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.|Up to Day 16|All participants who received at least one dose of study medication.|||Number of participants|||Number
1242505|NCT00561821|Secondary|Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary|Satisfaction of Sleep Duration (SSD) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Units on a Scale||Standard Deviation|Mean
1242506|NCT00561821|Secondary|Average Subjective Quality of Sleep Based on Sleep Diary|Quality of Sleep (QS) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Units on a Scale||Standard Deviation|Mean
1242507|NCT00561821|Secondary|Average Subjective Wake Time After Sleep Onset Based on Sleep Diary|Wake Time after Sleep Onset (WASO) is after falling asleep initially, the subjective time that the participant was awake during the night. Daily recordings by the participant in an electronic diary (observed data only), were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242508|NCT00561821|Secondary|Average Subjective Number of Awakenings Based on Sleep Diary|Number of awakenings between sleep onset and final awakening (NAW) is a subjective number (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Number of Awakenings||Standard Deviation|Mean
1242509|NCT00561821|Secondary|Average Subjective Sleep Latency Based on Sleep Diary|Sleep latency (SL) is the time taken to fall asleep (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242510|NCT00561821|Secondary|Average Subjective Total Sleep Time Based on Sleep Diary|Total Sleep Time (TST) is a subjective time (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242511|NCT00561821|Secondary|Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography|Number of stage shifts to stage 1 of sleep or to awaken was measured by PSG. A stage shift is the transition measured by PSG between various sleep stages. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of the number of stage shifts (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Number of stage shifts||Standard Deviation|Mean
1242522|NCT00561795|Secondary|Cancer Antigen (CA-125) Response|Defined as the number of participants who achieved a confirmed CA-125 response, which is defined as at least a 50% reduction in CA-125 levels from a pre-treatment sample.|Baseline until response (up to 2 years)||||participants|||Number
1242512|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the fourth quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242513|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the third quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242514|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the second quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242515|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the first quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242516|NCT00561821|Secondary|Average Number of Awakenings Measured by Polysomnography|Number of awakenings (NAW) was measured by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of NAW (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Number of awakenings||Standard Deviation|Mean
1242517|NCT00561821|Secondary|Average Total Sleep Time Measured by Polysomnography|Total sleep time (TST) is the sleep time recorded by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of TST (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242518|NCT00561821|Secondary|Average Latency to Persistent Sleep Measured by Polysomnography|Latency to Persistent Sleep (LPS) is the time from lights out to the first 20 consecutive epochs scored as sleep by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of LPS (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242519|NCT00561821|Primary|Average Wake Time After Sleep Onset Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The intent to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
1242520|NCT00561795|Primary|Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events|"Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the Adverse Event section of the results record for additional details and data."|Baseline to End of Study (up to a year)||||participants|||Number
1242523|NCT00561795|Secondary|Overall Response|Although the study protocol specified several efficacy analyses, due to poor tolerability of the combination regimen and the consequent early withdrawal of most participants, which led to a small sample size, efficacy analyses were not performed. Overall response is defined as the number of participants with CR or PR per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|Baseline until either response or progression (up to 2 years)||||participants|||Number
1242524|NCT00561730|Secondary|Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||Percentage of participants|||Number
1242525|NCT00561730|Secondary|Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||Percentage of participants|||Number
1242526|NCT00561730|Secondary|Physician's Assessment of Painful Swallowing|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1242527|NCT00561730|Secondary|Physician's Assessment of Acid Eructation|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1242528|NCT00561730|Secondary|Physician's Assessment of Heartburn|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1242529|NCT00561730|Primary|Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1755~Day 1 = 1740~Day 2 = 1740~Day 3 = 1733~Day 4 = 1732~Day 5 = 1725~Day 6 = 1727"|||Units on a scale||Standard Deviation|Mean
1242530|NCT00561730|Primary|Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1755~Day 1 = 1744~Day 2 = 1742~Day 3 = 1728~Day 4 = 1727~Day 5 = 1724~Day 6 = 1726"|||Units on a scale||Standard Deviation|Mean
1242531|NCT00561730|Primary|Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1754~Day 1 = 1742~Day 2 = 1739~Day 3 = 1733~Day 4 = 1730~Day 5 = 1726~Day 6 = 1729"|||Units on a scale||Standard Deviation|Mean
1242532|NCT00561730|Primary|Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1760~Day 1 = 1750~Day 2 = 1746~Day 3 = 1735~Day 4 = 1735~Day 5 = 1730~Day 6 = 1734"|||Units on a scale||Standard Deviation|Mean
1242533|NCT00561730|Primary|Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1767~Day 1 = 1758~Day 2 = 1757~Day 3 = 1744~Day 4 = 1743~Day 5 = 1739~Day 6 = 1739"|||Units on a scale||Standard Deviation|Mean
1242534|NCT00561730|Primary|Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1769~Day 1 = 1760~Day 2 = 1761~Day 3 = 1751~Day 4 = 1749~Day 5 = 1742~Day 6 = 1747"|||Units on a scale||Standard Deviation|Mean
1242535|NCT00561678|Secondary|Length of Stay|Length of Stay (LOS) in the hospital|average 4 days||||days||Inter-Quartile Range|Median
1242536|NCT00561678|Secondary|Intraoperative Hypertension|Number of participants with intraoperative hypertension|day 1||||Participants|||Count of Participants
1242537|NCT00561678|Secondary|Intraoperative Hypotension|Number of participants with intraoperative hypotension|day 1||||Participants|||Count of Participants
1242538|NCT00561678|Secondary|Intraoperative Bradycardia|Number of participants with intraoperative bradycardia|day 1||||Participants|||Count of Participants
1242539|NCT00561678|Secondary|Neuropsychological Testing|Rate of change of cognitive function - data not collected because secondary analysis which was not performed|at 3 months postoperatively|||||||
1242540|NCT00561678|Primary|Delirium Battery|Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU)|Day 1||||Participants|||Count of Participants
1242541|NCT00561652|Other Pre-specified|Participant Adherence With Week 26 Follow-up Questionnaire|Number of participants who completed week 26 follow-up questionnaire|26 weeks||||participants|||Number
1242542|NCT00561652|Other Pre-specified|Participant Adherence With Week 12 Follow-up Questionnaire|Number of participants who completed their week 12 follow-up questionnaire|12 weeks||||participants|||Number
1242543|NCT00561652|Other Pre-specified|Participant Adherence With Week 6 Follow-up Questionnaire|Number of participants who completed their week 6 follow-up questionnaire|6 weeks||||participants|||Number
1242544|NCT00561652|Other Pre-specified|Participant Adherence With Prescribed Home Exercise|Number of participants who completed at least 20 hours of home exercise|12 weeks||||participants|||Number
1242574|NCT00561600|Secondary|T-Test of Harris Hip Total Score Means at 24 Months|T-Test of Harris Hip total score means at 24 months|24 months||||Units on a scale of 0-100,100 is best.||Standard Deviation|Mean
1242545|NCT00561652|Other Pre-specified|"Participant Adherence With Time and Attention Visits"|"Number of participants who completed at least 8 of 10 time and attention visits. Note that only arm 1 (nonchiropractic arm) receives time and attention visits."|12 weeks|"Only arm 1 received time and attention visits as their purpose was to balance the chiropractor provider contact time received by arm 2 participants."|||participants|||Number
1242546|NCT00561652|Primary|Participant Adherence With Education + Exercise Visits|Number of participants completing at least 3 of 4 education + exercise visits|12 weeks||||participants|||Number
1242547|NCT00561652|Other Pre-specified|Participant Adherence With Chiropractic Visits|Number of participants who completed at least 12 chiropractic visits.|12 weeks||||participants|||Number
1242548|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte chromium|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242549|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242550|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242551|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242552|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte chromium|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242553|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte cobalt|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242554|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242555|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242556|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242557|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242558|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242559|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242560|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|12 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242561|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|12 Months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242562|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|12 Months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242563|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|12 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242564|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242565|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242566|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|4 months post operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242567|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242568|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|Pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242569|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte cobalt|pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242570|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242571|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|Pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
1242572|NCT00561600|Secondary|Harris Hip Function Score at 24 Months|Mean Harris Hip Function sub score at 24 months|24 months||||units on a scale 0-47. 47 is best||Standard Deviation|Mean
1242573|NCT00561600|Secondary|Harris Hip Pain Sub Score at 24 Months|Mean Harris Hip Pain sub score|24 months||||units on scale of 0-44. 44 is best||Standard Deviation|Mean
1242575|NCT00561600|Primary|Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes|"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score => 80 at 24 months"|24-month interval.|Out of the 265 enrolled subjects, 51 subjects were removed from the analysis for the following reasons: 2 deaths (1 inv, 1 control); 4 protocol violations (0 inv, 4 control); 6 consent withdrawn (2 inv, 4 control); 39 lost to follow-up (17 inv, 22 control).|||participants|||Number
1242576|NCT00561574|Secondary|Change From Baseline in Number of Awakenings (NAW)|"NAW was defined as the time recorded by participants in response to Weekly Sleep Diary question 2a During the past 7 nights, how many times did you wake up, on average? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline NAW assessment.|||Number of Awakenings||Standard Deviation|Mean
1242577|NCT00561574|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how long did it take you to fall asleep, on average? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline SL assessment.|||Minutes||Standard Deviation|Mean
1242578|NCT00561574|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how much time were you awake, on average, after falling asleep initially? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline WASO assessment.|||Minutes||Standard Deviation|Mean
1242579|NCT00561574|Secondary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how much time did you actually spend sleeping, on average?. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a last observation carried forward (LOCF) approach."|Baseline and Week 52|The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had at least one postbaseline TST assessment.|||Minutes||Standard Deviation|Mean
1242580|NCT00561574|Primary|Change From Baseline in Total Nap Time|"Total nap time was assessed by participants in response to Weekly Sleep Diary question 9a How much time per day did you nap, on average?. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.|||Minutes||Standard Deviation|Mean
1242581|NCT00561574|Primary|Change From Baseline in Ability to Work/Function|"Ability to work/function was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 8 How were you able to work or function over the past 7 days?. Scores could range from 0=Not at all to 100=Very well. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.|||Score on a Scale||Standard Deviation|Mean
1242582|NCT00561574|Primary|Change From Baseline in Feeling Full of Energy|"Feeling full of energy was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 7 How full of energy have you felt over the past 7 days?. Scores could range from 0=Terribly tired to 100=Full of energy. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.|||Score on a Scale||Standard Deviation|Mean
1242583|NCT00561574|Primary|Change From Baseline in Alertness at Awakening|"Alertness at awakening was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 6 How did you feel upon awakening over the past 7 days?. Scores could range from 0=Tired to 100=Alert. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an observed cases (OC) approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.|||Score on a Scale||Standard Deviation|Mean
1242584|NCT00561574|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 52 weeks|The AST population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1242585|NCT00561574|Primary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 53 weeks|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1242586|NCT00561470|Secondary|Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay|Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.|Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo|Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline.|||participants|||Number
1242654|NCT00561080|Secondary|Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2|The percentage of participants that reported an injection site reaction that was not specifically prompted by the diary card within 28 days post-dose 2 was recorded.|up to 28 days post-dose 2|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
1242587|NCT00561470|Secondary|Number of Participants With Adverse Events (AE)|"All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization.~The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported."|From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized|The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).|||participants|||Number
1242588|NCT00561470|Secondary|Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria|"The overall ORR was the percentage of evaluable participants who achieved complete response [CR] or partial response [PR] according to RECIST criteria version 1.0.~CR reflected the disappearance of all tumor lesions (with no new tumors)~PR reflected a pre-defined reduction in tumor burden~Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 – 6 weeks."|From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)|The evaluable patient population (EPP) for tumor response included all randomized participants with measurable disease at study entry, as per IRC evaluation, and with at least one valid post-baseline tumor evaluation.|||percentage of participants||95% Confidence Interval|Number
1242589|NCT00561470|Secondary|Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)|"PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC.~PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.~The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred."|From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)|Intent to Treat (ITT) population included all participants who gave informed consent and were randomized.|||months|Participants|Inter-Quartile Range|Median
1242590|NCT00561470|Primary|Overall Survival (OS)|"Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011).~OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model."|From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)|Intent-to-treat population (ITT) – all participants who gave informed consent and were randomized.|||months|Participants|Inter-Quartile Range|Median
1242591|NCT00561457|Primary|Rate of Major Adverse Clinical Events (MACE)|Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (> 50%) at nine months postprocedure.|9-months|The analysis was an intention to treat (ITT)population which included the data for all completed patients (those who had a MACE event within 9-months and those who reached 9 months without experiencing an event). Natural censoring was used in the analysis according to the statistical analysis plan.|||MACE events per 9 months||95% Confidence Interval|Mean
1242592|NCT00561431|Secondary|Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT|The number of participants who recover renal function at 30 days after enrollment in each arm.|Up to 30 days|intention to treat|||Participants|||Number
1242593|NCT00561431|Primary|Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.|Up to 30 days|Intention to treat|||participants|||Number
1242594|NCT00561418|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 3 years|Unable to calculate time to progression for patients due to not enough follow up time||||||
1242595|NCT00561418|Secondary|Duration of Response|Median follow up of living patients|Up to 5 years||||months||Full Range|Median
1242596|NCT00561418|Secondary|Clinical Benefit|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years|Response following AHSCT|||patients|||Number
1242597|NCT00561418|Primary|Safety and Tolerability of Vorinostat (SAHA) After Autologous Stem Cell Transplantation|NCI CTCAE version 3.0 was used to assess Adverse Events (AE) Grade 1=Mild AE Grade 2=Moderate AE Grade 3=Severe AE Grade 4=Life-threatening or disabling AE|Up to 3 years||||patients|||Number
1242598|NCT00561392|Secondary|Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24|The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden. A negative change score indicates reduced burden.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Units on a scale||Standard Deviation|Mean
1242599|NCT00561392|Primary|Percentage of Participants Who Were Compliant to the 10 cm^2 Patch|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Percentage of participants||Standard Deviation|Mean
1242600|NCT00561392|Primary|Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Percentage of participants||95% Confidence Interval|Number
1242601|NCT00561392|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver|The ADCS-CGIC is an assessment tool to make a judgment of change in a patient’s condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline.|Baseline t0 Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Participants|||Number
1242602|NCT00561392|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician|The ADCS-CGIC is an assessment tool to make a judgment of change in a patient’s condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. Results are reported as number of patients in the indicated change category.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Participants|||Number
1242603|NCT00561392|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24|The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||Units on a scale||Standard Deviation|Mean
1242604|NCT00561392|Secondary|Mean Change From Baseline in the Trail-making Test Part A Score at Week 24|The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Seconds||Standard Deviation|Mean
1242605|NCT00561392|Secondary|Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline and Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Units on a scale||Standard Deviation|Mean
1242606|NCT00561392|Primary|Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Percentage of participants||95% Confidence Interval|Number
1242613|NCT00561353|Secondary|Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the mean (standard deviation) Cmax for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right were 8, 8, 10, and 3.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/mL||Standard Deviation|Mean
1243283|NCT00557193|Secondary|Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts|FLT3 protein expression will be described via mean and standard deviation in samples determined to have acquired resistance to lestaurtinib.|Up to 12 weeks||2019-03-31|03/2019||||
1242607|NCT00561353|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-experienced HCV-infected participants considered non-responders (participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV ribonucleic acid (RNA) levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up at selected time points following treatment with TMC435 coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right was 8, 7, 10, and 3.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng.h/mL||Standard Deviation|Mean
1242608|NCT00561353|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-naïve HCV-infected participants administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng.h/mL||Standard Deviation|Mean
1242609|NCT00561353|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) of Css,av for TMC435 in treatment-experienced HCV-infected participants (non-responders and relapsers, see defined above) at selected time points following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/ml||Standard Deviation|Mean
1242610|NCT00561353|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows mean (standard deviation)of Css,av for TMC435 in treatment-naïve HCV-infected participants at selected time points administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10."|Day 7 (predose); Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel A, Cohorts 1 and 2) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel B, Cohorts 1 and 2)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/ml||Standard Deviation|Mean
1242611|NCT00561353|Secondary|Predose Plasma Concentration (C0h) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) of C0h for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 2 and Day 28 differed as follows: At Day 2, the number of participants in the 4 treatment groups (from left to right) were 8, 7, 10, and 5; the number of participants analyzed at Day 28 in the 4 treatment groups (from left to right) were 9, 8, 10, and 4.|Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/mL||Standard Deviation|Mean
1242612|NCT00561353|Secondary|Predose Plasma Concentration (C0h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows mean (standard deviation) of C0h of TMC435 at selected time points following treatment with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) or with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B) in treatment-naïve participants (see treatment-naïve defined above).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 9, 8, 9, 9, and 10."|Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/ml||Standard Deviation|Mean
1242638|NCT00561145|Secondary|Resting Energy Expenditure, Body Composition and Body Weight||Before and after the energy restriction period|||||||
1242639|NCT00561145|Secondary|Gastrointestinal Function||Before and after the energy restriction period|||||||
1242614|NCT00561353|Secondary|Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows the mean (standard deviation) Cmax for treatment-naïve participants at selected time points who were treated with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10."|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/mL||Standard Deviation|Mean
1242615|NCT00561353|Secondary|Sustained Virologic Response (SVR) in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) in each treatment group in Cohort 4, Panel C and in Cohort 5, Panel D with an SVR to treatment defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of the entire treatment regimen. SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively).|SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242616|NCT00561353|Secondary|Sustained Virologic Response (SVR) in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|"The table below shows the number of treatment-naïve participants with an SVR to treatment (defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively). See treatment-naïve defined above."|SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242617|NCT00561353|Secondary|Viral Relapse in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants combined (non-responders and relapsers, see defined above) with viral relapse, defined as having confirmed detectable plasma level of HCV ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment who received TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Up to Week 72|The analysis population used to evaluate viral relapse included participants in the intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) who were treatment-experienced and had undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|||Participants|||Number
1242618|NCT00561353|Secondary|Viral Relapse in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|"The table below shows the number of treatment-naïve participants with viral relapse (defined as having confirmed detectable plasma level of HCV ribonucleic acid [RNA] during the follow-up period in participants with undetectable plasma HCV RNA [less than 25 IU/mL undetectable] at the end of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). See treatment-naïve defined above."|Up to Week 72|The analysis population used to evaluate viral relapse included participants in the intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) who were treatment-naïve and had undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|||Participants|||Number
1242619|NCT00561353|Secondary|Viral Breakthrough in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|4 Weeks (Wks), 44 Wks, and 48 Wks|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242620|NCT00561353|Secondary|Viral Breakthrough in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1, Panel A and B)|The table below shows the number of treatment-naïve participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached, or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) after treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on days 8, 15, and 22 (Panel A) and after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).|4 Weeks (Wks), 44 Wks, and 48 Wks|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses. Note: Number of participants analyzed during the PegIFNα-2a and ribavirin treatment period of up to 44 weeks is N=16 for TMC435 25 mg, N=17 for TMC435 75 mg, and N=17 for TMC435 200 mg.|||Participants|||Number
1242640|NCT00561145|Secondary|Appetite/Satiety Hormones and Questionnaires||Before and after the energy restriction period.|||||||
1243284|NCT00557193|Secondary|Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts|FLT3 protein expression will be described (via mean and standard deviation) in samples determined to have primary resistance to lestaurtinib.|Up to 12 weeks||2019-03-31|03/2019||||
1242621|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with an initial suboptimal response defined as less than 2 log10 change of plasma in plasma level of HCV ribonucleic acid (RNA) at Day 2 or 3 (depending when visit was scheduled) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Day 2 or 3|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242622|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)|"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. See treatment-naive defined above."|Day 2 or 3|The intent-to-treat (ITT) population, defined as all participants who were randomized and received at least one dose of study medication (TMC435) was used for all analyses.|||Participants|||Number
1242623|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)|"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22. See treatment-naive defined above."|Day 2 or 3|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242624|NCT00561353|Secondary|Virologic Response Parameters Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12; a complete EVR (cEVR) defined as a EVR having undetectable plasma HCV RNA at Week 12; an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment.|Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242625|NCT00561353|Secondary|Virologic Response Parameters in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|The table below shows the number of treatment-naïve participants in the treatment groups for Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined) who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12); a complete EVR (cEVR) defined as a complete EVR having undetectable plasma HCV RNA at Week 12); an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment.|Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242626|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. Note: in the table below, the number of participants (n) analyzed in the TMC435 200 mg (Cohort 4, Panel B) on Day 28 (Week 4) was n=4.|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242627|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)|"The table below shows the number of treatment-naive HCV-Infected participants with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above."|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242653|NCT00561080|Secondary|Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1|Percentage of participants who reported herpes zoster or zoster-like rash following the 1st dose of vaccine were recorded.|up to 28 days post-dose 1|All randomized participants in Groups 1, 2, and 3 who received 1st dose of the study drug and who have safety follow-up data for post-dose 1.|||Percentage of Participants|||Number
1242628|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)|"The table below shows the number of treatment-naïve HCV-infected participants treated with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 who had the following virologic responses: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above."|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
1242629|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1242630|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1242631|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1242632|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1242633|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1242634|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo as for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1242635|NCT00561340|Primary|Height Change|Change in height from baseline to 6 months|6 months|29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.|||centimeters||Standard Deviation|Mean
1242636|NCT00561340|Primary|Weight Change|Change in weight observed from baseline to 6 months|6 months|29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.|||kilograms||Standard Deviation|Mean
1242637|NCT00561145|Secondary|Expression of Genes Involved in Energy Metabolism||Before and after the energy restriction period.|||||||
1242641|NCT00561145|Primary|Energy Intake Compensation|"To assess energy intake compensation, we will assess average energy intake during the ad libitum food intake phase - which is the period after energy restriction- in young men and compare this to average energy intake in older men.~Average energy intake is assessed by measuring total megajoule of energy intake during nine days of the ad lib phase, and then divide it by nine (MJ/day)"|Average intake of energy during ad lib phase (9 days)|completed (see publication)|||MJ/day||Standard Deviation|Mean
1242642|NCT00561080|Secondary|Percentage of Participants Who Died During the Study|The number of participants who died for any reason during the study was summarized.|up to end of study (approximately 15 months)|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
1242643|NCT00561080|Secondary|Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event|"A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. The percentage of participants who reported an SAE during the entire study period that was considered at least possibly -related to the vaccine were recorded."|up to end of study (approximately 15 months)|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
1242644|NCT00561080|Secondary|Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2|"A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. The percentage of participants who reported an SAE within 28 days of 1st dose of vaccine were recorded."|up to 28 days after 2nd vaccination|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
1242645|NCT00561080|Secondary|Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1|"A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. The percentage of participants who reported an SAE within 28 days of 1st dose of vaccine were recorded."|up to 28 days after 1st vaccination|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
1242646|NCT00561080|Secondary|Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) and were reported as at least possibly related to the vaccine were summarized,|up to 28 days after 2nd vaccination|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
1242647|NCT00561080|Secondary|Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) and were reported as at least possibly related to the vaccine were summarized|up to 28 days after 1st vaccination|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
1242648|NCT00561080|Secondary|Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized,|up to 28 days after 2nd vaccination|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
1242649|NCT00561080|Secondary|Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized|up to 28 days after 1st vaccination|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
1242650|NCT00561080|Secondary|Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2|Percentage of participants that reported varicella or varicella-like rash following the 2nd dose of vaccine were recorded.|up to 28 days post-dose 2|All randomized participants in Groups 2 and 3 who received 2nd dose of the study drug and who have safety follow-up data for post-dose 2.|||Percentage of Participants|||Number
1242651|NCT00561080|Secondary|Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1|Percentage of participants that reported varicella or varicella-like rash following the 1st dose of vaccine were recorded.|up to 28 days post-dose 1|All randomized participants in Groups 1, 2 and 3 who received 1st dose of the study drug and who have safety follow-up data for post-dose 1.|||Percentage of Participants|||Number
1242652|NCT00561080|Secondary|Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2|Percentage of participants who reported herpes zoster or zoster-like rash following the 2nd dose of vaccine were recorded.|up to 28 days post-dose 2|All randomized participants in Groups 2 and 3 who received 2nd dose of the study drug and who have safety follow-up data for post-dose 2.|||Percentage of Participants|||Number
1242966|NCT00559377|Secondary|Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor|The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.|Up to 2 years|11 tissue samples with Hif1, VEGF, p53 and EGFR IHC values were compared to FMISO uptake.|||units on a scale 0=low, 8=high||Full Range|Median
1242655|NCT00561080|Secondary|Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1|The percentage of participants who reported an injection site reaction that was not specifically prompted by the diary card within 28 day of 1st vaccination was recorded.|up to 28 days after 1st of study drug|All randomized participants in Groups 1, 2, and 3 who received at least 1 dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
1242656|NCT00561080|Secondary|Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2|Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain|up to 4 days after 2nd vaccination|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
1242657|NCT00561080|Secondary|Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1|Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain|up to 4 days after 1st vaccination|All randomized participants in Groups 1, 2 and 3 who received the 1st dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
1242658|NCT00561080|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 24 And 36 Months Post-dose 1 in Group 1 and From Pre-vaccination To 24 And 36 Months Post-dose 2 in Groups 2 and 3|Blood samples were to be taken at predose and 24 months post- last vaccination in Groups 1 , 2, and 3 to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was to be calculated for each arm as GMT 24-month post last dose divided by pre-vaccination GMT.|Predose 1 and 24 and 36 months post-last dose|Study stopped after 12 months. As per protocol, the study was stopped after the 12-month follow-up since there was no statistical evidence or clinical trend for superiority of any of the 2-dose regimens compared with the 1-dose regimen. 24 and 36 month data not obtained.||||||
1242659|NCT00561080|Secondary|Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3|Blood sample taken at 36 months post last-vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.|24 and 36 months post-last dose|Study stopped after 12 months. As per protocol, the study was stopped after the 12-month follow-up since there was no statistical evidence or clinical trend for superiority of any of the 2-dose regimens compared with the 1-dose regimen. 24 and 36 month data not obtained.||||||
1242660|NCT00561080|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3|Blood sample taken at predose and 1 year post last vaccination to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was calculated for each arm as GMT 12-month post last dose divided by pre-vaccination GMT.|predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)|All randomized participants who received at least 1 dose of the study vaccine, had 12-month post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242661|NCT00561080|Secondary|Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose|Blood sample taken at 1 year post last vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.|1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)|All randomized participants in who received at least 1 dose of the study vaccine, had 12-month post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242662|NCT00561080|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3|Blood sample taken at predose (Day 0) and 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The GMFR was calculated following each vaccination as GMT Post-dose/GMT Pre-vaccination|Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)|All randomized participants in who received at least 1 dose of the study vaccine, had pre-dose 1 evaluation and had post-vaccination immunogenicity evaluation. Excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242663|NCT00561080|Secondary|Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1|Blood sample taken at 4 weeks post vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA.|4 weeks post-dose (Month 1)|All randomized participants in Group 1 who received study vaccine, had post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242664|NCT00561080|Primary|Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3|Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).|4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)|All randomized participants in Groups 2 and 3 who received at least 1 dose of the study vaccine, had post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242665|NCT00561015|Secondary|Percentage of Participants Who Achieved Sustained Virological Response (SVR)|The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Week 12, 24 after EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.|||percentage of participants|||Number
1242666|NCT00561015|Secondary|Percentage of Participants Who Demonstrated Virological Relapse|Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|24 weeks after EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||percentage of participants|||Number
1242667|NCT00561015|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline, Day 12, 15 and Week 24/26|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.|||percentage of participants|||Number
1242668|NCT00561015|Secondary|Median Time to Virological Response (HCV RNA Level < 10 IU/ml)|Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline up to EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.|||days||Full Range|Median
1242669|NCT00561015|Secondary|Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)|Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).|Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'n' included those participants who were evaluable for this measure at specific time points.|||percentage of participants|||Number
1242670|NCT00561015|Primary|Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1|The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng*hr/ml||Standard Deviation|Mean
1242671|NCT00561015|Secondary|Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15|The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1242672|NCT00561015|Secondary|Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15|The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1242673|NCT00561015|Secondary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26|Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline and Week 24/26|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||log10 IU/ml||Full Range|Median
1242674|NCT00561015|Secondary|Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15|The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng*hr/ml||Standard Deviation|Mean
1242675|NCT00561015|Primary|Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1|The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||hr||Full Range|Median
1242676|NCT00561015|Primary|Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1|The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1242692|NCT00560937|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)|The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance.|Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
1242677|NCT00561015|Primary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15|Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.|Baseline, Pre-dose (Day 15)|Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of TVR or placebo.|||log10 IU/ml||Full Range|Median
1242678|NCT00561002|Other Pre-specified|Seroconversion Rates for Each Influenza Antigen Post-Vaccination|Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer < 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.|Day 14 post-vaccination|The seroconversion analysis were on the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1242679|NCT00561002|Other Pre-specified|Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)|Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.|Day 14 post-vaccination|The serum hemagglutination inhibition antibody analysis were on the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1242680|NCT00561002|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination||Day 0 and Day 14 after last dose of Fluzone|The Geometric Mean Titers analysis were on the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
1242681|NCT00561002|Primary|Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation|Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.|Days 0-3 post-dose|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1242682|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242683|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242684|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242685|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242686|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8|"Blood drawn at Day 1 and Day 30 of the~extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA."|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242687|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B|"Blood drawn at Day 1 and Day 30 of the~extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA."|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242688|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242689|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1242690|NCT00560937|Secondary|Mean Score on the Positive and Negative Symptom Scale (PANSS)|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.|Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
1242691|NCT00560937|Secondary|Clinical Global Impression Scale (CGI-I)|The CGI-I is a commonly used psychiatric scale to assess overall general improvement. The CGI-I consists of one interviewer-rated question on a scale of 1-7. Lower scores are indicative of fewer symptoms; while higher scores are indicative of more symptoms.|CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
1242693|NCT00560937|Primary|Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.|Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
1242694|NCT00560937|Secondary|Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS is used measure to investigate depressive symptoms in schizophrenia. The measure includes 9 questions ranked from 0 (no symptoms) to 3 (severe symptoms). Range of possible scores: 0-27.|Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
1242695|NCT00560937|Primary|Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048|The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms).|SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|Pilot proof of concept study|||units on a scale||Standard Deviation|Mean
1242696|NCT00560885|Secondary|Composite 6-month Post-procedure Major Adverse Event Rate.||6 Months Post Procedure|Safety was evaluated in all subjects enrolled and treated with the device.|||percentage of subjects||95% Confidence Interval|Number
1242697|NCT00560885|Secondary|Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.||6 Months Post Procedure|The analysis population included subjects that were evaluable for the Secondary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.|||percentage of subjects||95% Confidence Interval|Number
1242698|NCT00560885|Primary|Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.|30 days Post Procedure|Safety was evaluated in all subjects enrolled and treated with the device.|||percentage of subjects||95% Confidence Interval|Number
1242699|NCT00560885|Primary|Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.||6 Months Post Procedure|The analysis population included subjects that were evaluable for the Primary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.|||percentage of subjects||95% Confidence Interval|Number
1242700|NCT00560859|Secondary|Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale|Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.|7 months following baseline.|There was missing data for some children in the Watchful Waiting group since the Pediatric Sleep Questionnaire was not completed. Hence these numbers are not consistent with the rows in the participant flow module|||units on a scale||Standard Deviation|Mean
1242701|NCT00560859|Secondary|Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months|The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.|7 months following the baseline visit.||||Events per hour||Inter-Quartile Range|Median
1242702|NCT00560859|Primary|Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.|The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.|The primary endpoint measure will occur at 7 months following the baseline visit.||||units on a scale||Standard Deviation|Mean
1242703|NCT00560833|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.|||score on a scale||Standard Deviation|Mean
1242715|NCT00560794|Secondary|Change From Screening Value in B-cell Count During Cycle 1|B-cells were measured by flow cytometry.|At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.|Participants who received blinatumomab with available pharmacodynamic data.|||cells/μL||Standard Deviation|Mean
1242726|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2|Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.|Up to Day 84 (up to 42 days after ProQuad® Dose 2)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242704|NCT00560833|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.|||score on a scale||Standard Deviation|Mean
1242705|NCT00560833|Primary|Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12|Participants recorded the frequency of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.|||number of events||Standard Deviation|Mean
1242706|NCT00560833|Secondary|Change From Baseline in Vasomotor Symptoms Score Per Women's Health Questionnaire (WHQ) at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants receiving study drug with diary compliance adequate for this measure.|||Score on a scale||Standard Deviation|Mean
1242707|NCT00560833|Primary|Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4|Participants recorded the frequency of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The intent-to-treat (ITT) population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.|||Number of events||Standard Deviation|Mean
1242708|NCT00560794|Secondary|Terminal Half-life of Blinatumomab||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||hours||Standard Deviation|Mean
1242709|NCT00560794|Secondary|Clearance of Blinatumomab||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||L/hr/m²||Standard Deviation|Mean
1242710|NCT00560794|Secondary|Apparent Volume of Distribution||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||L/m²||Standard Deviation|Mean
1242711|NCT00560794|Secondary|Area Under the Drug Concentration-time Curve From Time Zero to Infinity||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||hr*ng/mL||Standard Deviation|Mean
1242712|NCT00560794|Secondary|Serum Blinatumomab Concentration at Steady State|The mean serum concentration of blinatumomab during cycle 1. The LOQ of the assay was 100 pg/mL, and the limit of detection (LOD) was 3 pg/mL.|Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||pg/mL||Standard Deviation|Mean
1242713|NCT00560794|Secondary|Serum Cytokine Peak Levels in Cycle 1|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using fluorescence-activated cell sorter (FACS)-based cytometric bead array (CBA) system.The limit of detection (LOD) for the cytokine determination was 20 pg/mL, the limit of quantification (LOQ) was 125 pg/mL.|Cycle 1 at pre-dose and at post infusion start at 45 minutes; 2, 6, 12, 24, and 48 hours; 7, 14, 21, and 28 days.|Safety analysis set|||pg/mL||Standard Deviation|Mean
1242714|NCT00560794|Secondary|Change From Screening Value in T-cell Count During Cycle 1|T-cells were measured by flow cytometry.|At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.|Participants who received blinatumomab with available pharmacodynamic data.|||cells/μL||Standard Deviation|Mean
1242716|NCT00560794|Secondary|Number of Participants With Adverse Events|"The severity (or intensity) of AEs was evaluated according to the grading scale provided in the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, or according to the following: Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~A serious adverse event (SAE) is any untoward medical occurrence or effect that, at any dose results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. In addition, all laboratory abnormalities of grade four severity that occur during or after administration of the investigational drug, any overdose and a pregnancy or fathering were reported as SAEs."|From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.|Safety analysis set, including all participants who received ≥ 1 infusion of blinatumomab.|||participants|||Number
1242717|NCT00560794|Secondary|Time to MRD Relapse|"Time to MRD relapse is defined only for participants with an MRD response during the study, defined as the time between the date of the first MRD response and the date of MRD relapse. If a participant experienced hematological relapse without having shown MRD positivity before then the time point of MRD relapse is defined as the time point of hematological relapse. Participants without an event of MRD relapse or hematological relapse were censored on the day of their last available bone marrow aspiration/biopsy. If a participant received a bone marrow transplant the last day of bone marrow aspiration/biopsy before transplantation was used as time point for censoring.~MRD relapse is defined as reappearance of bcr/abl, and/or t(4;11) translocation at any detection level, and/or by individual rearrangements of immunoglobulin or T-cell receptor genes ≥10^-4 for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4 and should be confirmed within 6 weeks."|Up to the data cut-off date of 14 January 2010; Median follow-up time was 116.5 days|Full analysis set|||days||95% Confidence Interval|Median
1242718|NCT00560794|Secondary|Time to MRD Progression|"Time to MRD progression is defined for participants who do not show MRD response at any time during the study as the time from start of first infusion until the first result of MRD progression or hematological relapse, if no MRD progression was diagnosed before hematological relapse. For participants who showed MRD response during the study the time to MRD progression is defined as the time from the date of the first MRD response to the date of MRD relapse. Participants without an event of MRD progression were censored on the day of their last bone marrow aspiration/biopsy. Participants who received a bone marrow transplant were censored on the last day of bone marrow aspiration/biopsy before transplantation.~MRD progression is defined as the increase in the MRD level by 1 log as compared to the baseline level (equal to a 10-fold increase in the number of MRD cells), and had to be confirmed within 6 weeks."|Up to the data cut-off date of 14 January 2010; Median follow-up time was 155 days|Full analysis set|||days||95% Confidence Interval|Median
1242719|NCT00560794|Secondary|Time to Hematological Relapse|"The time to hematological relapse is defined as the time between start of first infusion of blinatumomab and the first result of hematological relapse. Participants without an event of hematological relapse were censored on their last available date of bone marrow aspiration/biopsy.~Hematological relapse is defined as > 5% leukemia cells in bone marrow. Time to hematological relapse was analyzed using Kaplan-Meier methods."|Up to the data cut-off date of 14 January 2010; maximum duration of follow-up was 564 days.|Full analysis set|||days||95% Confidence Interval|Median
1242720|NCT00560794|Secondary|Percentage of Participants With an MRD Response After Each Treatment Cycle|"MRD Response is defined as:~If Philadelphia Chromosome (Ph)+ or t(4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.~If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4."|At the end of each treatment cycle - Weeks 4, 10, 16, and 22.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1242721|NCT00560794|Primary|Percentage of Participants With a Minimal Residual Disease (MRD) Response Within 4 Cycles of Treatment|"MRD Response is defined as:~If Philadelphia Chromosome (Ph) positive (+) or translocation (t) (4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.~If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4."|Within 4 treatment cycles, 24 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1242722|NCT00560755|Secondary|Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1|Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242723|NCT00560755|Secondary|Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1|The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants|||Number
1242724|NCT00560755|Secondary|Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1|Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242725|NCT00560755|Secondary|Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1|The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.|From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242743|NCT00560612|Secondary|Connor Davidson Resilience Scale|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.|12 weeks|||||||
1242727|NCT00560755|Primary|Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2|Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.|Up to Day 84 (up to 42 days after ProQuad® Dose 2)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242728|NCT00560755|Primary|Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2|The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242729|NCT00560755|Primary|Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2|Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242730|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2|Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242731|NCT00560755|Primary|Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2|Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242732|NCT00560755|Primary|Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2|Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242733|NCT00560755|Primary|Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2|The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242734|NCT00560755|Primary|Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2|The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.|Up to Day 46 (for 4 days following ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242735|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2|The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242736|NCT00560755|Primary|Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2|The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1242737|NCT00560703|Primary|Change in Ocular Surface Disease Index (OSDI)|"OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4):~OSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA)~Range of OSDI is 0 to 100 (higher score indicates worse condition)."|Baseline to Week 12||||Scores on a scale||Standard Deviation|Mean
1242738|NCT00560703|Primary|Change in Bulbar Conjunctival Hyperemia|"Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable:~None (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness"|Baseline to Week 12||||Scores on a scale||Standard Deviation|Mean
1242739|NCT00560612|Secondary|Sheehan Disability Scale (SDS)|"Rates the following (scale 1-10; 1= not at all, 10=extremely) Work, Social Life, Family Life/Home Responsibilities.~Perceived Stress and Social Supports Scale (scale 1-10; 1= not at all, 10=extremely) Perceived stress, perceived social support"|12 weeks|||||||
1242740|NCT00560612|Secondary|Symptom Checklist 90|"Individual symptom scales are determined (via computer scoring) as follows:~SOM - Somatization O-C - Obsessive-Compulsive I-S - Interpersonal Sensitivity DEP - Depression ANX - Anxiety HOS - Hostility PHOB - Phobic Anxiety PAR - Paranoid Ideation PSY - Psychoticism~Global Indices Global Severity Index (GSI): Designed to measure overall psychological distress.~Positive Symptom Distress Index (PSDI): Designed to measure the intensity of symptoms.~Positive Symptom Total (PST): Reports number of self-reported symptoms."|12 weeks|||||||
1242741|NCT00560612|Secondary|Clinical Global Impressions of Severity and of Improvement Scales|"The severity of illness is rated on a scale of 1-7; 1 being normal and 7 being among the most extremely ill patients.~Global improvement is similarly rated on a scale of 1-7; 1 being very much improved and 7 being very much worse."|12 weeks|||||||
1242742|NCT00560612|Secondary|Hospital Anxiety and Depression Scale|Separate depression and anxiety scores are determined from this measure. Possible ranges for both depression and anxiety scores: 0-21. 0-7 (normal); 8-10 (borderline abnormal); 11-21 (abnormal).|12 weeks|||||||
1242744|NCT00560612|Secondary|Short PTSD Rating Interview|"8 questions rated on 0-4 scale (0=not at all; 4=very much). One question assesses how much better the subject feels since beginning treatment (0-100; 0= no change; 100= very much change). Final question assesses how much symptoms have improved since starting treatment (forced choice: worse; no change; minimally; much; very much).~Total score is computed from questions #1-8 (range=0-32)."|12 weeks|||||||
1242745|NCT00560612|Primary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Baseline and 12 weeks||||Units on a scale||Standard Deviation|Mean
1242746|NCT00560573|Other Pre-specified|Recommended Phase 2 Dose (RP2D)|The RP2D was determined after review and discussion by sponsor and investigators of the study data. Consideration was given to type and severity of toxicity as well as clinical suitability for long-term administration|Baseline to end of dose escalation, which was assessed in the last participant of the dose escalation portion of the study in Month 19|Safety analysis set: All enrolled participants who received at least 1 dose of study medication.|||mg/kg|||Number
1242747|NCT00560573|Other Pre-specified|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1|Cycle 1, up to Day 21|Safety analysis set: All enrolled participants who received at least 1 dose of study medication.|||mg/kg|||Number
1242748|NCT00560573|Secondary|Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels|To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment|Baseline, Day 8, end of study|Biomarker analysis set: All enrolled participants who received at least 1 dose of study medication.|||ng/mL||Inter-Quartile Range|Mean
1242749|NCT00560573|Secondary|Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab|Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab|30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose)|ADA analysis set: All enrolled participants who received at least 1 dose of study medication.|||Percentage of participants|||Number
1242750|NCT00560573|Secondary|Duration of Response (DR)|For responding patients (CR and PR): Time from the date that CR or PR was first recorded to the date of the first documentation of progression|Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|No analysis of this parameter was performed. Due to the exploratory nature of the study, the analysis of the efficacy of figitumumab was limited to the assessment of clinical benefit response and PFS.||||||
1242751|NCT00560573|Secondary|Progression-Free Survival (PFS)|Time from the date of enrollment to date of documented disease progression, or death due to any cause|Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.|||months||95% Confidence Interval|Median
1242752|NCT00560573|Secondary|Percentage of Participants With Objective Response or Prolonged Stabilization|Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response|Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.|||Percentage of participants||95% Confidence Interval|Number
1242753|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng*hr/L||Standard Deviation|Mean
1242754|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pemetrexed|Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng/mL||Standard Deviation|Mean
1242755|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng*hr/L||Standard Deviation|Mean
1242756|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Gemcitabine|Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab|0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng/L||Standard Deviation|Mean
1242757|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng*hr/L||Standard Deviation|Mean
1242758|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Cisplatin|Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab|0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||nanogram (ng)/mL||Standard Deviation|Mean
1242759|NCT00560573|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab|Concentration at the end of Cycle 4|0 (pre-dose) in Cycle 5 Day 1|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||mg/L||Standard Deviation|Mean
1242760|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods|0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||mg*hr/L||Standard Deviation|Mean
1242761|NCT00560573|Secondary|Concentration at the End of Infusion (Cinf) for Figitumumab|Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods|Cycle 1 for dose escalation and Cycle 4 for dose expansion|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||mg/liter (L)||Standard Deviation|Mean
1242762|NCT00560573|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment|Start of treatment up to end of Cycle 1, Day 21|Safety analysis set: All enrolled participants in the dose escalation who received at least 1 dose of study medication.|||participants|||Number
1242763|NCT00560560|Secondary|Counts of Circulating Tumor Cells (CTCs)|The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.|Cycle 1 pre-dosing and Cycle 4 pre-dosing|"All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. N means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively."|||Number of CTC/ml of blood||Standard Deviation|Median
1242764|NCT00560560|Secondary|Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)|The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.|Cycle 1 pre-dosing and Cycle 4 pre-dosing|"All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. N means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively."|||number of CTC expressing IGF-1R/ml blood||Standard Deviation|Median
1242765|NCT00560560|Secondary|Participants Reporting Positive for Total Anti-drug Antibodies (ADA)|The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.|Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)|Participants for whom at least one ADA measurement was done. The outcome was not analyzed and only listing of ADA level for each participant was available.||||||
1242766|NCT00560560|Secondary|Descriptive Summary of Figitumumab Concentration Versus Time|The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5|Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5|All participants for whom PK was assessed at least once. The numbers of participants analyzed are numbers of observation (non-missing concentrations). The numbers for 20 mg/kg group are 84,7,3,2,13 for five cycles, respectively. The numbers for 30 mg/kg group are 79,8,2,2,8 for five cycles, respectively.|||miligrams/liter (mg/L)||Standard Deviation|Mean
1242767|NCT00560560|Secondary|Percentage of Participants With Objective Response|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.|Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months|Per protocol. All enrolled participants who started treatment, with measurable disease and adequate baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
1242783|NCT00560508|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)|Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse).|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||percentage of participants|||Number
1242768|NCT00560560|Secondary|Progression-Free Survival (PFS)|The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.|Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.|All enrolled participants.|||months||95% Confidence Interval|Median
1242769|NCT00560560|Secondary|Overall Survival|The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.|From date of enrollment until death or censorship, up to 33 months|All enrolled participants.|||Months||95% Confidence Interval|Median
1242770|NCT00560560|Primary|Estimate of the 6 Month Survival Probability|The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.|Baseline up to Month 6|All enrolled participants.|||Percent chance of survival||95% Confidence Interval|Number
1242771|NCT00560508|Secondary|Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)|UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Deviation|Mean
1242772|NCT00560508|Secondary|Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)|UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
1242773|NCT00560508|Secondary|Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)|UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Deviation|Mean
1242774|NCT00560508|Secondary|Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)|UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Deviation|Mean
1242775|NCT00560508|Secondary|Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)|The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||mg per day||Standard Deviation|Mean
1242776|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of on-time||Standard Deviation|Mean
1242777|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of on-time||Standard Deviation|Mean
1242778|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of on-time||Standard Deviation|Mean
1242779|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)|Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of on-time||Standard Deviation|Mean
1242780|NCT00560508|Secondary|Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)|Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of off-time||Standard Deviation|Mean
1242781|NCT00560508|Secondary|UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)|Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||percentage of participants|||Number
1242782|NCT00560508|Secondary|Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Deviation|Mean
1243285|NCT00557193|Secondary|Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy|PIA (Plasma Inhibitory Activity) levels in infants given lestaurtinib at DL2 in combination with chemotherapy will be summarized with mean and standard deviation for those with available data.|Up to 12 weeks||2019-03-31|03/2019||||
1242784|NCT00560508|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)|Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse)|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||percentage of participants|||Number
1242785|NCT00560508|Secondary|Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)|Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase)|Week 12 to Week 16|Full Analysis Set (FAS 2) for the open-label period|||percentage of participants|||Number
1242786|NCT00560508|Secondary|Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline.|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
1242787|NCT00560508|Secondary|Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment|Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration|from Visit 1 to Visit 8 after pramipexole ER|Full Analysis Set (FAS).|||ng/mL|Participants|Standard Error|Mean
1242788|NCT00560508|Secondary|Trough Plasma Concentration at Steady State|Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg.|at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment|Full Analysis Set (FAS)|||ng/ml||Standard Deviation|Geometric Mean
1242789|NCT00560508|Primary|Percentage of Participants Who Experienced Adverse Events|An adverse event is defined as any untoward medical occurrence|12 weeks|Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.|||percentage of participants|||Number
1242790|NCT00560508|Secondary|Change From Baseline in L-dopa Daily Dose|The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||mg per day||Standard Error|Least Squares Mean
1242791|NCT00560508|Secondary|UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)|Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||percentage of participants|||Number
1242792|NCT00560508|Secondary|Change From Baseline in UPDRS Part IV Score|UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
1242793|NCT00560508|Secondary|Change From Baseline in UPDRS Part III Score|UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
1242794|NCT00560508|Secondary|Change From Baseline in UPDRS Part II Score|UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
1242795|NCT00560508|Secondary|Change From Baseline in UPDRS Part I Score|UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
1242796|NCT00560508|Secondary|Responder Rate For Patient Global Impression of Improvement (PGI-I)|PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring of 1 or 2 (at least much better)|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||percentage of participants|||Number
1242797|NCT00560508|Secondary|Responder Rate For Clinical Global Impression of Improvement (CGI-I)|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||percentage of participants|||Number
1242798|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia|Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of on-time||Standard Error|Least Squares Mean
1242799|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia|Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of on-time||Standard Error|Least Squares Mean
1242800|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia|Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of on-time||Standard Error|Least Squares Mean
1247764|NCT00527332|Primary|Duration of Hospital Stay.|Duration of hospital stay defined as time from start anesthesia to leaving the hospital|Within 6 months after surgery|Participants who completed the study were analyzed|||Hours||Full Range|Median
1242801|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia|Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of on-time||Standard Error|Least Squares Mean
1242802|NCT00560508|Secondary|Change From Baseline in Percentage Off-time|Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of off-time||Standard Error|Least Squares Mean
1242803|NCT00560508|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
1242804|NCT00560417|Secondary|Total Daily Insulin Dose at Endpoint (LOCF)||Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||Units of Insulin||Standard Deviation|Mean
1242805|NCT00560417|Secondary|Change From Baseline in Body Weight at Endpoint (LOCF)||Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||kilograms||Standard Deviation|Mean
1242806|NCT00560417|Secondary|Actual Body Weight at Baseline and Endpoint (LOCF)||Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||kilograms||Standard Deviation|Mean
1242807|NCT00560417|Secondary|Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)|Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.|Baseline to Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||episodes/participant/365 days||Standard Deviation|Mean
1242808|NCT00560417|Secondary|Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)|Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.|Baseline to Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percentage of participants|||Number
1242809|NCT00560417|Secondary|Glycemic Variability at Baseline and Endpoint (LOCF)|Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||mg/dL||Standard Deviation|Mean
1242810|NCT00560417|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)|SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1242811|NCT00560417|Secondary|Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%||Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percent of participants|||Number
1242812|NCT00560417|Secondary|Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.|Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
1242813|NCT00560417|Secondary|Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.|24 weeks, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
1242814|NCT00560417|Primary|Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
1242815|NCT00560404|Secondary|Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40|Vital signs included blood pressure, pulse rate and body weight.|From Baseline to Week 40|The analysis was performed on safety population.|||participants|||Number
1242816|NCT00560404|Secondary|Number of Participants With Abnormal Changes in ECG From Baseline to Week 40|Twelve-lead ECG was performed.|From Baseline to Week 40|The analysis was performed on Safety population.|||participants|||Number
1247765|NCT00527319|Primary|Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength||4 weeks||||participants|||Number
1242817|NCT00560404|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 40|The analysis was performed on Safety Population.|||participants|||Number
1242818|NCT00560404|Secondary|Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36|The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point..|||International units/Liter||Standard Deviation|Mean
1242819|NCT00560404|Secondary|Mean Values of Transferrin Saturation at Baseline and Week 36|The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||percentage||Standard Deviation|Mean
1242820|NCT00560404|Secondary|Mean Values of Ferritin Concentration at Baseline and Week 36|Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||micrograms per liter||Standard Deviation|Mean
1242821|NCT00560404|Secondary|Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36|The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||gram/litre||Standard Deviation|Mean
1242822|NCT00560404|Secondary|Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36|Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||micromoles per liter||Standard Deviation|Mean
1242823|NCT00560404|Secondary|Mean Values of Leukocytes and Platelets Count at Baseline and Week 36|The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||10^9/Litre||Standard Deviation|Mean
1242824|NCT00560404|Secondary|Mean Values of Mean Corpuscular Volume at Baseline and Week 36|Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||femtoliters||Standard Deviation|Mean
1242825|NCT00560404|Secondary|Mean Values of Hematocrit at Baseline and Week 36|Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||fraction||Standard Deviation|Mean
1242826|NCT00560404|Secondary|Mean Values of Hemoglobin Concentration at Baseline and Week 36|The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||g/dL||Standard Deviation|Mean
1242827|NCT00560404|Secondary|Number of Participants Received Red Blood Cells Transfusions|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.|Up to Week 28|The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not|||participants|||Number
1242828|NCT00560404|Secondary|Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period|The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.|EEP (Weeks 29 to 36)|The analysis was performed on ITT population.|||participants|||Number
1242829|NCT00560404|Secondary|Number of Participants Who Required Dose Adjustments During the Dose Titration Period|The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.|DTP (Weeks 0 to 28)|The analysis was performed on ITT population.|||participants|||Number
1242830|NCT00560404|Secondary|Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period|Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.|EEP (Week 29 to Week 36)|The analysis was performed on ITT population.|||days||Standard Deviation|Mean
1247766|NCT00527319|Primary|Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass||4 weeks||||participants|||Number
1242831|NCT00560404|Secondary|Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period|Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.|EEP (Weeks 29 to 36)|The analysis was performed on ITT population.|||percentage of participants|||Number
1242832|NCT00560404|Secondary|Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period|The Baseline (Safety Verification Period) was from Week - 4 to Week -1.|Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)|The analysis was performed on ITT population.|||g/dL||Standard Deviation|Mean
1242833|NCT00560404|Primary|Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period|The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.|EEP (Week 29 to Week 36)|Per-protocol population included participants who received at least one dose of C.E.R.A. and had data of at least one follow-up variable excluding those participants who had not adhere the inclusion/exclusion criteria, had less than 3 recorded Hb values, and received any other epoetin alpha and blood transfusion in Weeks 0 to 44.|||percentage of participants|||Number
1242834|NCT00560391|Primary|Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus|Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: <LLN – 8.0 mg/dL, GR2: <8.0 – 7.0 mg/dL, GR3: <7.0 – 6.0 mg/dL, GR4: <6.0 mg/dL. Calcium (High): GR1: >ULN – 11.5 mg/dL, GR2: >11.5 – 12.5 mg/dL, GR3: >12.5 – 13.5 mg/dL, GR4: >13.5 mg/dL. Magnesium (Low): GR1: <LLN – 1.2 mg/dL, GR2: <1.2 – 0.9 mg/dL, GR3: <0.9 – 0.7 mg/dL, GR4: <0.7 mg/dL. Phosphorus (low): GR1: <LLN – 2.5 mg/dL, GR2: <2.5 – 2.0 mg/dL, GR3: <2.0 – 1.0 mg/dL, GR4: <1.0 mg/dL. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
1242835|NCT00560391|Secondary|Number of Participants With Minimal Response|Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required.|Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
1242836|NCT00560391|Secondary|Number of Participants With Partial Response|Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to <200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required.|Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
1242837|NCT00560391|Primary|Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)|Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN; TB:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN; SC: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
1242838|NCT00560391|Primary|Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia|As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=<LLN(lower limit of normal)-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3:<2.0-1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9/L; GR2=<1.5-1.0*10^9/L; GR3:<1.0-0.5*10^9/L; GR4:<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3:<8.0-6.5g/dL; GR4:<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3:<50.0-25.0*10^9/L; GR4:<25.0*10^9/L. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
1242839|NCT00560391|Primary|Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.|Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
1242840|NCT00560391|Secondary|Number of Participants With Complete Response and Very Good Partial Response|Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component < 100 mg per 24 hour.|Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
1242841|NCT00560391|Primary|Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone|The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.|From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)|||participants|||Number
1242842|NCT00560391|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia >5 days/neutropenic fever;platelet count <10000mm^3 on >1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of >=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for >15 days due to any toxicity related to treatment with the combination.|From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)|||participants|||Number
1242843|NCT00560391|Primary|Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)|The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.|From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||mg|||Number
1242844|NCT00560352|Primary|MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone|MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended dose is the maximum dose that the participants received.|Days 1 to 21|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone|||mg/m^2|||Number
1242845|NCT00560352|Secondary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening.|Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone.|||Participants|||Number
1242846|NCT00560352|Secondary|Progression-free Survival|Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population.|Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone|||Months||95% Confidence Interval|Median
1242847|NCT00560352|Secondary|Duration of Response|Duration of response calculated for those with best response=CR (M-protein [MP] undetectable by immunofixation [IF], ≤5% plasma cells in bone marrow, no soft tissue plasmacytomas); VGPR (MP detectable by IF, or ≥90% drop in serum [S] MP and urine [U] MP<100 mg/24h); PR(≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size); or MR (≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC). Duration of response calculated from day criteria for CR, VGPR, PR, and MR were met until progression or death, whichever came first.|First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)|All response-evaluable participants who achieved a response.|||Months|||Number
1242861|NCT00560235|Secondary|Overall Survival (OS)|Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment|All enrolled participants with ESFT and who started treatment with figitumumab.|||months||95% Confidence Interval|Median
1242862|NCT00560235|Secondary|Progression-Free Survival (PFS)|PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).|Baseline and every cycle (4 weeks), until progression or death|All enrolled participants with ESFT and who started treatment with figitumumab.|||months||95% Confidence Interval|Median
1242848|NCT00560352|Secondary|Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry|S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia.|Day 1 until last tumor assessment (maximum reached: 9 months)|All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone|||Percentage of participants|||Number
1242849|NCT00560352|Primary|Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone|MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.|Days 1 to 21|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone|||mg QD|||Number
1242850|NCT00560313|Primary|Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.|The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.|One month after vaccinations|The analysis was done on the per protocol population.|||participants|||Number
1242851|NCT00560313|Primary|Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination|"Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:~prior to the first vaccination~30 days following the first, second, prior to the third and 30 days after the third vaccination"|One month after vaccinations|The analysis was done on the per protocol population.|||percentage||95% Confidence Interval|Number
1242852|NCT00560313|Primary|Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.|Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.|One month after vaccinations|The analysis was done on the per protocol population.|||titer||95% Confidence Interval|Geometric Mean
1242853|NCT00560313|Primary|Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.|"Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:~prior to the first vaccination~30 days following the first, second, prior to the third and 30 days after the third vaccination"|One month after vaccinations|The analysis was done on the per protocol population.|||percentage||95% Confidence Interval|Number
1242854|NCT00560313|Primary|Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.|Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.|One month after vaccinations|The analysis was done on the per protocol population.|||titer||95% Confidence Interval|Geometric Mean
1242855|NCT00560235|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) Titer|Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.|Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)|All enrolled participants with ESFT and who started treatment with figitumumab. None of the serum samples were positive for ADAs following repeated administration of figitumumab, as indicated by an endpoint titer of <6.64.|||participants|||Number
1242856|NCT00560235|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.|||mg*hr/L||Geometric Coefficient of Variation|Geometric Mean
1242857|NCT00560235|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 1 cycle (4 weeks) in this study.|Cycle 5: 1 hour post-infusion on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.|||milligram*hour per liter (mg*hr/L)||Geometric Coefficient of Variation|Geometric Mean
1242858|NCT00560235|Secondary|Plasma Concentration at End of Infusion (Cendinf)||Cycle 1 Day 2 and Cycle 5 Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1242859|NCT00560235|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)|Cmin is the concentration at the end of treatment cycle (next cycle predose).|Cycle 6: predose on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1242860|NCT00560235|Secondary|Maximum Observed Plasma Concentration (Cmax)||Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1|The pharmacokinetic (PK) analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.|||milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
1242863|NCT00560235|Primary|Objective Response Rate (ORR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.|Baseline and every cycle (4 weeks), for up to 6 cycles|All enrolled participants with Ewing's sarcoma family of tumors (ESFT) and who started treatment with figitumumab; number of evaluable participants at data cut-off.|||percentage of participants||95% Confidence Interval|Number
1242864|NCT00560105|Secondary|Change in CCQ Score|The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.|8 weeks|A patient population included|||units on a scale||Standard Deviation|Mean
1242865|NCT00560105|Secondary|Quality of Life Questionnaire/Daily Diary|St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)|8 weeks|All patient data included|||units on a scale||Standard Deviation|Mean
1242866|NCT00560105|Secondary|FEV1 - Baseline and Device Comparisons|Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.|8 weeks|A data collected included|||liter||Standard Deviation|Mean
1242867|NCT00560105|Primary|Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight|In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.|8 weeks|All patient data included|||g||Standard Deviation|Mean
1242868|NCT00560066|Primary|Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV|Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.|From Day 1 up to and including Day 7 post-vaccination|Analysis was performed on the safety dataset, i.e. all subjects in the exposed set who provided post-baseline safety data.|||Subjects|||Number
1242869|NCT00560066|Secondary|Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV|Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).|Three weeks post-vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.|||Ratio||95% Confidence Interval|Geometric Mean
1242870|NCT00560066|Secondary|Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV|Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).|Before vaccination (Day 1) and three weeks after vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.|||Titers||95% Confidence Interval|Geometric Mean
1242871|NCT00560066|Secondary|Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV|Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).|Three weeks post-vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.|||Percentages of Subjects||95% Confidence Interval|Number
1242872|NCT00560066|Secondary|Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV|Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).|Before vaccination (Day 1) and three weeks after vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions (full analysis set [FAS]: all enrolled subjects who received a study vaccine and provided one evaluable serum sample before and after baseline)|||Percentages of Subjects||95% Confidence Interval|Number
1242873|NCT00560066|Secondary|Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV|Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.|From Day 1 through Day 7 post-vaccination|Analysis was done on the subset of safety population which included the adults and elderly with underlying medical conditions.|||Subjects|||Number
1242874|NCT00560066|Secondary|Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV|Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).|From Day 1 through Day 7 post-vaccination|Analysis was done on a subset of safety population (i.e. all subjects in the exposed population who provide postvaccination safety data) which included the healthy adults and elderly.|||Subjects|||Number
1242876|NCT00559988|Secondary|Change in Quality of Life Score|Quality of Life was evaluated using the SF-36 v2 Health Survey. The SF-36 consists of eight scaled scores which correspond to the following sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are recoded per a scoring key with each question having a value from 0 to 100. Scores from items in the same scale are averaged together per the scoring key to create the section and subsection (physical health and mental health) scores. For all reported scores, the lowest possible value is 0 (representing the highest disability) and the highest possible value is 100 (representing no disability). Therefore, a positive change from baseline to 1 year represents an improvement in disability, while a negative change represents a worsening of disability.|1 year|Subjects with paired baseline and 1 year Quality of Life scores|||Scores on a scale||Standard Deviation|Mean
1242877|NCT00559988|Secondary|Rate of Cardioembolic and Non-cardioembolic Stroke||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
1242878|NCT00559988|Secondary|Mean Atrial Fibrillation/Atrial Flutter Burden||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||percent daily burden||Standard Deviation|Mean
1242879|NCT00559988|Secondary|Rate of Major Bleeding Events||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
1242880|NCT00559988|Secondary|Rate of Fatal or Disabling and Non-disabling Stroke||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
1242881|NCT00559988|Secondary|Rate of Ischemic and Hemorrhagic Stroke||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
1242882|NCT00559988|Secondary|Rates of All-cause Mortality||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
1242883|NCT00559988|Primary|Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed|The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.|From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years|Intent to treat analysis of all enrolled subjects|||percentage of participants-Kaplan Meier|||Number
1242884|NCT00559962|Secondary|Absolute Change From Baseline in Percent Hepatic Fat|Absolute change from Baseline in percent hepatic fat|Baseline and 12 weeks on study drug|ITT|||Percent of Hepatic Fat||Standard Deviation|Mean
1242885|NCT00559962|Primary|Absolute Change From Baseline in Percent Hepatic Fat|Absolute change from Baseline in percent hepatic fat|Baseline and 12 weeks on study drug|ITT|||Percent of Hepatic Fat||Standard Deviation|Mean
1242886|NCT00559949|Secondary|Overall Survival (OS)|Overall Survival using the Kaplan-Meier method with associated confidence intervals. OS analysis was intended to be mostly exploratory and descriptive in nature.|Up to 2 years|All participants|||months||95% Confidence Interval|Median
1242887|NCT00559949|Secondary|Occurrence of Treatment Related Adverse Events|Number of participants with related adverse events, per category and Grade category. Toxicity assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 2 years|All participants|||adverse events|||Number
1242888|NCT00559949|Secondary|Median Progression-Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Secondary end points include toxicity, progression free survival, and overall survival. Due to the small sample size and absence of high quality historic data for this disease, these analyses were planned to be mostly exploratory and descriptive in nature.|Up to 2 years|All participants|||weeks||95% Confidence Interval|Median
1242889|NCT00559949|Primary|Objective Response Rate (ORR)|ORR: Complete Response (CR) and Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A conservative estimate of the response rate of the best-studied agent in this disease, doxorubicin, is approximately 5%. Therefore, investigators will assume that selumetinib (AZD6244, NSC 741078) would be worth further pursuit if the response rate (CR+PR) were at least 20%.|Up to 2 years|All evaluable participants|||Participants|||Count of Participants
1242890|NCT00559936|Primary|Ocular and Systemic Safety|The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.|All study visits|Participants treated with investigational medication were analyzed.|||participants|||Number
1242891|NCT00559936|Primary|The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.|The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.|Six Months|Participants who received investigational treatment were analyzed.|||percent change since baseline||Standard Deviation|Mean
1242892|NCT00559897|Primary|PET Response Rate||FLT PET scan will be done 6-8 days after the dose of zoledronic acid|||||||
1243197|NCT00557505|Other Pre-specified|Time to Disease Progression|Time in weeks from start of study treatment to first documentation of objective disease progression or death due to disease, whichever comes first.|Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37|Data was not analyzed, as antitumor activity was not observed.|||weeks||Full Range|Median
1242893|NCT00559845|Secondary|Percentage of Participants Experiencing Any Adverse Event|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 7.5 years|Safety population, defined as all participants who received at least one infusion of Bevacizumab.|||percentage of participants|||Number
1242894|NCT00559845|Secondary|Overall Survival|Overall survival was defined as the time from enrollment of participant to death from any cause.|Up to 7.5 years|Data for the outcome measure was not collected.||||||
1242895|NCT00559845|Secondary|Percentage of Participants With Disease-Free Interval|Disease-free interval was defined as the time from enrollment until recurrence of tumor or death from any cause, and was estimated using the Kaplan-Meier method. The percentage of participants without events at Months 12, 24, 36, 48, and 60 is presented.|Months 12, 24, 36, 48, and 60|ITT population, defined as all participants that were included in the trial and underwent surgery. Here, number of participants analyzed signifies those participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
1242896|NCT00559845|Secondary|Percentage of Participants With Breast-Conserving Surgery|Rate of breast conversing surgery is defined as percentage of participants who achieved breast conversing surgery out of the ITT population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant treatment.|Up to 7.5 years|ITT population, defined as all participants that were included in the trial and underwent surgery.|||percentage of participants|||Number
1242897|NCT00559845|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of participants with a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions; PR was defined as a 30% decrease in sum of longest diameter of target lesions.|Up to 7.5 years|ITT population, defined as all participants that were included in the trial and underwent surgery.|||percentage of participants|||Number
1242898|NCT00559845|Primary|Percentage of Participants With Pathological Complete Response Following Principle Investigator Review|Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.|Up to 7.5 years|Intention-to-Treat (ITT) population, defined as all participants that were included in the trial and underwent surgery.|||percentage of participants|||Number
1242899|NCT00559754|Secondary|Percentage of Participants With pCR by RKISS1 Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. RKISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242900|NCT00559754|Secondary|Percentage of Participants With pCR by KISS1 Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242901|NCT00559754|Secondary|Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. AGTR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242902|NCT00559754|Secondary|Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. pMAPK gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242903|NCT00559754|Secondary|Percentage of Participants With pCR by ENOS Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. ENOS gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242904|NCT00559754|Secondary|Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. IGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242905|NCT00559754|Secondary|Percentage of Participants With pCR by HIF Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. HIF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242906|NCT00559754|Secondary|Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. pAKT gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242907|NCT00559754|Secondary|Percentage of Participants With pCR by VEGFR Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGFR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242908|NCT00559754|Secondary|Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242909|NCT00559754|Secondary|Percentage of Participants With pCR by Angiotension Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. Angiotensin protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242910|NCT00559754|Secondary|Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. ENOS protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242911|NCT00559754|Secondary|Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. HIF protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242912|NCT00559754|Secondary|Percentage of Participants With pCR by VEGFR Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGFR protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242913|NCT00559754|Secondary|Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEFGR amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242914|NCT00559754|Secondary|Percentage of Participants With pCR by KISS1 Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242915|NCT00559754|Secondary|Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
1242916|NCT00559754|Secondary|Percentage of Participants With pCR by Proliferation of Ki67|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. Biomarker Ki67 proliferation was defined as low (less than [<]15% ) and high (≥15%).|After Week 24 (surgery)|Population evaluable for anatomopathological response with evaluable levels of the specified biomarker; data were missing for 2 participants.|||percentage of participants|||Number
1242917|NCT00559754|Secondary|Percentage of Participants With Breast-Conserving Surgery|Breast-conserving surgery was defined as lumpectomy + lymphadenectomy (LA), segmentectomy + LA, quadrantectomy + LA, or other (including sentinal node extirpation tumorectomy).|Week 24|ITT population; only those participants who underwent surgery were included in the analysis|||percentage of participants|||Number
1242918|NCT00559754|Secondary|Percentage of Participants With Objective Clinical Response|Overall clinical response is the best response obtained through physical examination and/or radiological tests after completion of chemotherapy cycles. The percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) and was categorized as clinical response (CR+PR) or clinical benefit (CR+PR+ no change [NC]). Per RECIST, CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.|Within 28 days of enrollment, Weeks 12 and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
1242919|NCT00559754|Primary|Percentage of Participants With Pathological Complete Response (pCR)|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA). It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.|After Week 24 (surgery)|Population evaluable for anatomopathological response: participants who satisfied all inclusion criteria and none of the exclusion criteria, received at least 2 cycles of chemotherapy treatment, and were evaluated pathologically.|||percentage of participants||95% Confidence Interval|Number
1242920|NCT00559637|Secondary|Total Number of Red Blood Cell (RBC) Transfusions|RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).|Baseline to Month 9|ITT population|||number of transfusions|||Number
1242921|NCT00559637|Secondary|Total Number of Dose Adjustments|A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment.|Baseline until Month 8|ITT population|||dose adjustments|||Number
1242922|NCT00559637|Secondary|Time to Increase of Hemoglobin Value to Over 11 g/dL|The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL.|Baseline to Month 9|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Standard Deviation|Mean
1242923|NCT00559637|Secondary|Duration of Hemoglobin Values in the Range of 11-13 g/dL|The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.|Baseline to Month 9|ITT population|||months||Standard Deviation|Mean
1242924|NCT00559637|Primary|Change From Baseline in Hemoglobin Value to the Evaluation Phase|The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean.|Baseline, evaluation phase (Months 8 and 9)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||g/dL||Standard Deviation|Mean
1242925|NCT00559637|Secondary|Duration of Hemoglobin Values in the Range of 11-12 g/dL|The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.|Baseline to Month 9|ITT population|||months||Standard Deviation|Mean
1242967|NCT00559377|Primary|Disease-free Survival (DFS)|Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.|Up to 2 years|Of the 13 patients analyzed for disease-free survival, 10 remained disease-free throughout the 2 year follow up. For 3 patients, we could determine overall survival, but could not confirm whether or not they were disease-free.|||participants disease-free after 2 years|||Number
1242926|NCT00559637|Primary|Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL|Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.|Evaluation phase (Months 8 and 9)|ITT population|||percentage of participants||95% Confidence Interval|Number
1242927|NCT00559637|Primary|Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)|Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.|Evaluation phase (Months 8 and 9)|Intent to treat (ITT) population included all participants who received at least one dose of study medication with at least one hemoglobin value measured during treatment period.|||percentage of participants||95% Confidence Interval|Number
1242928|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator.|End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.|||participants|||Number
1242929|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements|Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.|||participants|||Number
1242930|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions.|End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.|||participants|||Number
1242931|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug|End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.|||participants|||Number
1242932|NCT00559585|Primary|Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population|Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized.|Days 85, and 169 and postvisits on Days 28, 56, and 85|All randomized participants in the Anti-TNF Failure Sub-study who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.|||participants|||Number
1242933|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821|The disability section of the full HAQ includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score.|Days 169, 729, 1261, 1821|All participants who entered the LT period, received at least 1 dose of study drug during the LT period, and had HAD-QI scores at baseline and at specified days were summarized.|||participants|||Number
1242934|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||participants|||Number
1242968|NCT00559377|Primary|Overall Survival (OS)|Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.|For up to 2 years|1 patient has been lost to follow up for survival measures.|||participants still alive after 2 years|||Number
1242935|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||participants|||Number
1242936|NCT00559585|Secondary|Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||units on a scale||95% Confidence Interval|Mean
1242937|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821|The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||participants|||Number
1242938|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||participants|||Number
1242939|NCT00559585|Secondary|Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline|Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.|||participants|||Number
1242940|NCT00559585|Secondary|Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized|An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment.|Days 85, and 169 and postvisits on Days 28, 56, and 85|All participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result reported during the short-term period.|||participants|||Number
1242941|NCT00559585|Secondary|Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period|C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit.|Baseline to Days 15, 29, 57, 85, 113, 141, and 169|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.|||percent change||Inter-Quartile Range|Median
1242942|NCT00559585|Secondary|Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept (anti-ABA) or anti-CTLA4 antibody (anti-CTLA4).|Days 85, and 169 and postvisits on Days 28, 56, and 85|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.|||participants|||Number
1242943|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept|Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141.|Dosing Interval between Days 113 and 141 (TAU=28 days)|Participants in the sub-study who received at least 1 dose of study medication and who had adequate PK profiles for analysis|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1242944|NCT00559585|Secondary|Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept||Dosing interval between Days 113 and 141 (TAU=28 days)|Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis|||µg*h/mL||Standard Deviation|Geometric Mean
1242981|NCT00559104|Primary|Mortality|Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.|Assessed at date of death post-transplant|per protocol|||participants|||Number
1242945|NCT00559585|Secondary|Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept|Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL).|End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous|Participants in the Sub-study who received at least 1 dose of study medication and who had adequate PK profiles were analyzed|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1242946|NCT00559585|Secondary|Double-blind Period: Maximum Observed Serum Concentration of Abatacept||End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous|Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis|||µg/mL||Standard Deviation|Geometric Mean
1242947|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept|Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169.|Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period)|Participants who received at least 1 dose of study medication and who had adequate PK profiles were analyzed. n= number of participants available at each specific time point.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1242948|NCT00559585|Secondary|Double-blind Period: Minimum Observed Serum Concentration of Abatacept||Days 57, 85, 113, 120, 127, 134, 141, and 169|Participants who received at least 1 dose of study medication and from whom at least 1 pharmacokinetic (PK) sample was collected and reported (N). Only participants with adequate PK profiles were included in the summary statistics and statistical analysis (n).|||µg/mL||Standard Deviation|Geometric Mean
1242949|NCT00559585|Secondary|Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality|Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or <LLN|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. N=number of participants with assessments available.|||participants|||Number
1242950|NCT00559585|Secondary|Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality|Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN, use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-glutamyl transferase (GGT): >2* ULN, or if BL>ULN, use >3*BL; bilirubin: >2* ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2* BL; creatinine: >1.5*BL|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.|||participants|||Number
1242951|NCT00559585|Secondary|Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; BL= baseline. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; hematocrit: <0.75*BL; erythrocytes: <0.75*BL; platelets: <0.67*LLN/>1.5*ULN, or if BL<LLN, use <0.5*BL and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.|||participants|||Number
1242952|NCT00559585|Secondary|Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements|Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1242953|NCT00559585|Secondary|Double-blind Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions|Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1242954|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1242982|NCT00559104|Primary|Progression|"Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first.~Below is reported Progression-free Survival: event is relapse or progression, or death."|Assessed at date of progression post-transplant|per protocol|||participants|||Number
1242983|NCT00559013|Primary|Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.||Discharge and 1 Month post surgery||||Participants|||Number
1242955|NCT00559585|Secondary|Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug|Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1242956|NCT00559585|Secondary|Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169|The disability section of the full HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.|Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available|||participants|||Number
1242957|NCT00559585|Secondary|Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0.|Baseline to Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.|||units on a scale||Standard Error|Mean
1242958|NCT00559585|Secondary|Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169|The disability section of the full HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered.|Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.|||units on a scale||Standard Deviation|Mean
1242959|NCT00559585|Secondary|Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169|The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.|Day 169|PP population, defined as participants who are compliant with the study criteria.|||participants|||Number
1242960|NCT00559585|Primary|Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).|Day 169|Per protocol (PP) population, defined as participants who are compliant with the study criteria.|||participants|||Number
1242961|NCT00559507|Secondary|Median Time to Treatment Failure||From the start of treatment up to 4 weeks after completion of study treatment||||Days||Full Range|Median
1242962|NCT00559507|Secondary|Overall Response Rate (CR and PR)|Overall Response rate is defined as the sum of the complete response rate and partial response rate. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|From start of treatment to 24 weeks after completion of study treatment||||participants|||Number
1242963|NCT00559507|Primary|Disease Control Rate (DCR)|DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon’s two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|After 24 weeks of study therapy||||participants|||Number
1242964|NCT00559377|Secondary|Response to XRT Using RECIST|Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols|time to disease progression or 2 years following first FMISO scan|PET/CT acquisition was obtained using non-diagnostic low dose CT attenuation scans at the time of PET/CT imaging that limited our ability to accurately measure tumor dimensions and due to lack of complete data, we were not able to fulfill this aim.||||||
1242969|NCT00559364|Secondary|Percentage of Stools Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft and watery. Percentage of stools of a specific consistency for each patient was calculated as: (total number of stools of specific consistency during the completed days of the inpatient period/ total number of stools during the completed days of the inpatient period)*100. Mean percentage of stool categorized as per consistency for total patients was summarized.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|ITT population included all randomized patients.|||percentage of stools||Standard Deviation|Mean
1242970|NCT00559364|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each patient was calculated from frequency of stools by the patient per day. Mean daily number of stools during the collection period (Day 1 to Day 4 or Day 5 in inpatient period of treatment phase) for total patients was summarized.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|ITT population included all randomized patients.|||stools per day||Standard Deviation|Mean
1242971|NCT00559364|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which was collected from Day 1 to Day 4 or Day 5 during the inpatient period of treatment phase. Mean percent (%) CFA was calculated for Day 1 to Day 4 or Day 5 in inpatient period of treatment phase.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|Intent-to-treat (ITT) population included all randomized patients. Missing values at treatment phase were imputed using the median (50th percentile) of all non-missing values within a treatment group.|||percent CFA||Standard Deviation|Mean
1242972|NCT00559273|Secondary|Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response|The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.|Baseline to Week 28|ITT population. Here, N=number of participants analyzed for this measure.|||percentage of participants|||Number
1242973|NCT00559273|Secondary|Percentage of Participants With Stable Hemoglobin Response|A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.|Baseline to Week 28|ITT population.|||percentage of participants||95% Confidence Interval|Number
1242974|NCT00559273|Secondary|Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL|Percentage of participants having at least one Hb value greater than (>) 12 g/dL during the first 8 weeks of the study was reported.|Baseline to Week 8|ITT population. Here, N=number of participants evaluable for this measure.|||percentage of participants|||Number
1242975|NCT00559273|Secondary|Percentage of Participants With Red Blood Cell (RBC) Transfusions|The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.|Baseline up to Week 28|ITT population.|||percentage of participants|||Number
1242976|NCT00559273|Secondary|Time to Hemoglobin Response|Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb >=1.0 g/dL from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without RBC transfusion before response.|Baseline up to Week 28|ITT population.|||days||95% Confidence Interval|Median
1242977|NCT00559273|Secondary|Hemoglobin (Hb) Concentration Over the Time|The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)|ITT population. Here, n=number of evaluable participants at specified time point, respectively for each group.|||g/dL||Standard Deviation|Mean
1242978|NCT00559273|Primary|Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period|A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.|Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)|ITT population. Here, N (number of participants analyzed)=participants evaluable for this measure. Missing data were imputed using last value carried forward.|||g/dL||Standard Deviation|Mean
1242979|NCT00559273|Primary|Percentage of Participants With Hemoglobin (Hb) Response|Hb response was an observed increase in Hb greater than or equal to (>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.|Baseline up to Week 28|Intent-to-treat (ITT) population included all randomized participants. Participants were analyzed according to the study treatment assigned.|||percentage of participants||95% Confidence Interval|Number
1242980|NCT00559104|Secondary|Short-term and Long-term Treatment-related Toxicities|Patient may be assessed for toxicities any time after transplant, up to death, last contact date, or end-of-study date.|Any time after transplant|per protocol|||participants|||Number
1247831|NCT00526591|Other Pre-specified|Effect of Treatment on Biological and Molecular Markers|Immunohistochemical Staining of Cellular and Molecular Markers in Prostate Tumor Tissue|After 8 weeks of therapy|||||||
1242984|NCT00558896|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.|Duration of study (up to 5 years)|Participants who achieved a partial response(PR) or better were evaluable for this analysis.|||months||95% Confidence Interval|Median
1242985|NCT00558896|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method.~Progression was defined as any one or more of the following:~25% increase in serum M-component (absolute increase >= 0.5g/dl)~25% increase in urine M-component (absolute increase >= 200mg/24hour~25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~25% increase in bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
1242986|NCT00558896|Primary|The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)|"Response that was confirmed on 2 consecutive evaluations~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration of study (up to 3 years)||||participants|||Number
1242987|NCT00558870|Primary|Dose Escalation Index at Day 15 (+/- 3 Days)|Intended index period from baseline to Day 15 to determine whether the addition of low dose methadone to morphine (in the methadone group) has a lower dose escalation index as compared to the morphine alone (in the morphine group) at Day 15 (+/- 3 days). To determine whether the methadone group of individuals has a lower dose escalation index as compared to the morphine alone group: Participant dosages measured at baseline and daily until end of study (day 15), total daily dose of methadone converted to daily morphine equivalent daily dose for cancer pain and added to total daily morphine dosages. From these daily values, maximum dose recorded will be Opioid Maximum Dose (OMD). Opioid escalation index measured as described in Outcome 1 above (milligrams calculated by formula, (OMD-OSD)/days). Low index indicates achievement of adequate analgesia or appearance of uncontrollable side effects limiting upward titration over time.|Day 15 (+/- 3 days)|No analysis possible due to small participation numbers.||||||
1242988|NCT00558870|Primary|Number of Participants With Objective Response (OR)|Objective response (OR) is defined as a dose escalation index <20 where Opioid escalation index measured in milligrams is calculated by the formula, (OMD-OSD)/days, OMD = Opioid maximum dose as expressed in equianalgesic dose of oral morphine in milligrams, OSD= Opioid starting dose at the time of referral to palliative care/ pain specialist for the treatment of cancer pain as expressed in equianalgesic dose of oral morphine in milligrams. A low index indicates the achievement of adequate analgesia or appearance of uncontrollable side effects limiting upward titration over time. OR used in determining whether the addition of low dose methadone to morphine (in the methadone group) has a lower dose escalation index as compared to the morphine alone (in the morphine group) at Day 15.|Day 15 (+/- 3 days)|There were no participants analyzed in each group for outcome variable; the study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups.||||||
1242989|NCT00558831|Primary|Subject Reported Change From Baseline Scale|"-1=worse 0=unchanged~1=mild improvement~2=moderate improvement~3=clear"|baseline and 1 month||||Participants|||Number
1242990|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Specificity (%)|Participants||Number
1242991|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Sensitivity (%)|Participants||Number
1242992|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Specificity (%)|Participants||Number
1243031|NCT00558571|Primary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 6 weeks|treated set|||participants|||Number
1242993|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Sensitivity (%)|Participants||Number
1242994|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Specificity (%)|Participants||Number
1242995|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Sensitivity (%)|Participants||Number
1242996|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 3|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose||||Hounsfield Units||Standard Deviation|Mean
1242997|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 2|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose||||Hounsfield Units||Standard Deviation|Mean
1242998|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 1|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose||||Hounsfield Units||Standard Deviation|Mean
1242999|NCT00558792|Secondary|Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater|Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.|up to 72 hours post dose||||Participants who Experienced AE(s)|||Number
1243000|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose||||Segments Visualized Accurately|Participants||Number
1243001|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose||||Segments Visualized Accurately|Participants||Number
1243002|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose||||Segments Visualized Accurately|Participants||Number
1243003|NCT00558753|Secondary|Knee Range of Motion (Active Flexion)||1-30 days||||Degrees||Standard Error|Least Squares Mean
1243032|NCT00558571|Primary|Number of Subjects With Drug Related Adverse Events|number of subjects with investigator-defined drug-related adverse events.|from drug administration up to 6 weeks|treated set: comprised all 78 patients who received at least one dose of study medication|||participants|||Number
1243004|NCT00558753|Secondary|Neuropathic Pain (S-LANSS > 12)|Patients will be evaluated in blinded fashion for lower extremity Complex Regional Pain Syndrome(CRPS) at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews. An S-LANSS score of 12 or more was an indication of chronic neuropathic pain. Patients with an Self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) score of 12 or more at 6 mo came to the physician’s office for a standardized physical examination, which included the S-LANSS examination items (allodynia and hyperalgesia) directly assessed by the physician, plus a pinprick evaluation.|3 and 6 months post-surgery||||participants|||Number
1243005|NCT00558753|Primary|Epidural Medication Consumption Rate|Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria). Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use.|36 h|Because of structural missing data, sample sizes are smaller than the samples size for the secondary measure.|||mL/h||Standard Deviation|Mean
1243006|NCT00558701|Primary|Time to Wound Healing|Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing|20 days||||days||Full Range|Mean
1243007|NCT00558636|Secondary|Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 7|HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.|Change from baseline of HRQoL score assessed (at treatment Cycle 7 [21 days per cycle]) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.|||Units on a scale||Standard Deviation|Mean
1243008|NCT00558636|Secondary|Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 3 and Cycle 5|HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.|Change from baseline of HRQoL score assessed (at treatment Cycle 3 and Cycles 5 [21 days per cycle]) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.|||units on a scale||Standard Deviation|Mean
1243009|NCT00558636|Secondary|Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2|The LCS is a validated instrument for determining treatment impact on lung symptoms. The LCS consists of 7 questions with 5 responses ranging from “not at all” to “very much”. The LCS total score ranges from 0 to 28. Lower scores reflect greater lung cancer symptoms.|Change from baseline of LCS score assessed at each treatment cycle starting with Cycle 2 (Cycles 2, 3, 4, 5, 6, 7; 21 days per cycle) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 90 completed the LCS at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the response rate (number of evaluable subjects completing the questionnaire) decreased from cycle to cycle and makes the results hard to interpret.|||units on a scale||Standard Deviation|Mean
1243010|NCT00558636|Secondary|Duration of Response|Duration of response (PR or better) was defined as the time from the first documented objective PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Since only 4 subjects had a response, the duration of response was not calculated.|Time from first documented objective response (complete response or partial response) to disease progression or death, or to last tumor assessment if censored, up to 5 months after randomization of the first patient.|All subjects that showed a response. Since only 4 subjects had a response, the data were not analyzed.|||days|||Number
1243011|NCT00558636|Secondary|Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Complete response (CR): Disappearance of all target lesions (TL). Partial response (PR): At least 30% decrease in sum of the largest diameter (LD) of TLs, taking baseline sum as reference. Stable disease (SD): No change in tumor size. Progressive disease (PD): At least a 20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since treatment started, or the appearance of 1 or more new lesions.|Best tumor response assessed every 6 weeks by investigator during treatment up to 5 months after randomization of the first patient.|All randomized subjects (the intent to treat (ITT) population) were included in the analysis.|||Participants|||Number
1243012|NCT00558636|Secondary|Overall Survival (OS)|"Overall survival is the number of days from the date of randomization to the date of death due to any cause. Subjects alive at the time of analysis were censored at their last date of follow-up. Since the study was terminated early and 89% of subjects' data were censored, only the number of subjects who Failed (died) or were Censored is reported, not the usual measure number of days."|Up to 5 months after randomization of the first patient|All randomized subjects (the intent to treat (ITT) population) were included in the analysis. Since 89% of subjects were censored, OS could not be calculated. The number of subjects who Failed (died) or were Censored are reported.|||Participants|||Number
1243033|NCT00558558|Primary|Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)|Change in severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.|Baseline and Week 4 +/- 5 days|The participants were not eligible for analysis based on the primary outcome timeline.||||||
1243034|NCT00558467|Secondary|Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.||baseline and Week 6|Full Analysis Set (FAS).|||participants|||Number
1243013|NCT00558636|Primary|Progression Free Survival|"Progression free survival (PFS) is the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented. Since the study was terminated early and 89% of subjects' data were censored, only the number of PFS events (Failed [progressed or died before progression]) is reported, not the usual measure number of days."|Up to 5 months after randomization of the first patient|It was intended to include all randomized subjects (the intent to treat (ITT) population) in the analysis. Since 89% of subjects were censored, PFS could not be calculated. The number of subjects who Failed (progressed or died before progression) or were Censored are reported.|||Participants|||Number
1243014|NCT00558571|Secondary|HbA1c|change from baseline on day 28. Baseline is defined as day -1.|in the morning of days -1 and 28|PD analysis set|||percentage of hemoglobin||Standard Deviation|Mean
1243015|NCT00558571|Secondary|Fructosamine|change from baseline to days 14 and 18. Baseline is defined as day -1.|day -1 (baseline), 14 and 28|PD analysis set|||µmol/L||Standard Deviation|Mean
1243016|NCT00558571|Secondary|Glucagon AUEC0-5|Change from baseline (day -1) in AUEC0-5 on day 28.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|Pharmacodynamic (PD) analysis set: All patients who receive at least one dose of study medication (active drug or placebo) and had some PD data were included in the pharmacodynamic analysis.|||ng*h/L||Standard Deviation|Mean
1243017|NCT00558571|Secondary|Glucagon Emax (Maximum Measured Effect)|Change from baseline (day -1) in Emax on day 28.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set|||ng/L||Standard Deviation|Mean
1243018|NCT00558571|Secondary|Fasting Insulin|Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.|in the morning of days -1( baseline), 1, 7, 14, 21 and 28|PD analysis set|||µU/mL||Standard Deviation|Mean
1243019|NCT00558571|Secondary|Insulin Emax (Maximum Measured Effect)|change in Emax from baseline on day 28. Baseline is defined as day -1|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set|||µU/mL||Standard Deviation|Mean
1243020|NCT00558571|Secondary|Insulin AUEC0-5|change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set|||µU*h/mL||Standard Deviation|Mean
1243021|NCT00558571|Secondary|Mean Daily Glucose (MDG) Measured in Blood|change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27|PD analysis set|||mg/dL||Standard Deviation|Mean
1243022|NCT00558571|Secondary|Fasting Plasma Glucose (FPG)|fasting plasma glucose on day -1 (baseline) and change from baseline to day 28|in the morning of days -1 and 28|PD analysis set|||mg/dL||Standard Deviation|Mean
1243023|NCT00558571|Secondary|Ae0-24 of Glucose|Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)|Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h|PD analysis set|||mg||Geometric Coefficient of Variation|Geometric Mean
1243024|NCT00558571|Secondary|LI (Linearity Index).|The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28|PK analysis set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1243025|NCT00558571|Secondary|fe0-24 of Empagliflozin|Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set for patients who have fe data at day 1 and day 28|||percentage of Empagliflozin||Geometric Coefficient of Variation|Geometric Mean
1243026|NCT00558571|Secondary|CL/F of Empaglifozin|apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1243027|NCT00558571|Secondary|AUC0-∞ of Empagliflozin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1|PK analysis set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1243028|NCT00558571|Secondary|t1/2 of Empagliflozin|terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set|||hours||Geometric Coefficient of Variation|Geometric Mean
1243029|NCT00558571|Secondary|Tmax of Empagliflozin|time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set|||hours||Full Range|Median
1243030|NCT00558571|Secondary|Cmax of Empagliflozin|maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28).|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28|Pharmacokinetic (PK) analysis set: comprised all 62 patients who received Empagliflozin and had evaluable PK parameter data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1243035|NCT00558467|Secondary|Patient Global Impression at Week 6|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243036|NCT00558467|Secondary|Patient Global Impression at Week 4|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243037|NCT00558467|Secondary|Patient Global Impression at Week 3|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243038|NCT00558467|Secondary|Patient Global Impression at Week 2|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243039|NCT00558467|Secondary|Patient Global Impression at Week 1|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243040|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 6|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243041|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 4|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243042|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 3|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243043|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 2|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243044|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 1|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243045|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 6|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243046|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 4|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243047|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 3|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243048|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 2|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243049|NCT00558467|Secondary|Clinical Global Impressions - Improvement at 1 Week|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
1243050|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline 4 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
1243051|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 3 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
1243052|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 2 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
1243053|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline 1 week|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
1243054|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 6 weeks|The Full Analysis Set with last observation carried forward (LOCF).|||score on a scale||Standard Error|Least Squares Mean
1243055|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 4 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
1243056|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 3 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
1243057|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 2 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
1243058|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline 1 week|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
1243059|NCT00558467|Primary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale|"Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.~Analysis was adjusted for baseline total tic score and age as linear covariates."|baseline 6 weeks|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||score on a scale||Standard Error|Least Squares Mean
1243060|NCT00558428|Primary|Number of Patients With Oedema|Patients from the treated set who experienced at least one case of general oedema.|During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)|The treated set (TS) consisted of all patients that took at least one dose of the double-blind treatment (n=1097)|||patients|||Number
1243061|NCT00558428|Secondary|Trough Seated Blood Pressure (BP) Normality Classes|"The number of patients who reach predefined BP categories:~Optimal - SBP<120 and DBP<80 mmHg~Normal - SBP<130 and DBP<85 mmHg~High-normal - SBP<140 DBP<90 mmHg~Stage 1 hypertension - SBP<160 and DBP<100~Stage 2 hypertension SBP>=160 and DBP>=100 mmHg"|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
1243062|NCT00558428|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
1243063|NCT00558428|Secondary|Trough Seated SBP Control|The number of patients who reach the target SBP of <140mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
1243198|NCT00557505|Other Pre-specified|Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET)||Baseline, cycle 3 and after 8 weeks|Data was not analyzed, as development of the compound was terminated.|||standardized uptake value (SUV)||Standard Deviation|Mean
1243064|NCT00558428|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
1243065|NCT00558428|Secondary|Trough Seated Diastolic Blood Pressure Control|The number of patients who reach the target DBP of <90mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
1243066|NCT00558428|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)|Change from baseline to the end of study in trough SBP|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||mmHg||Standard Error|Least Squares Mean
1243067|NCT00558428|Primary|Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)|Change from baseline to the end of study in trough DBP|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||mmHg||Standard Error|Least Squares Mean
1243068|NCT00558363|Secondary|Number of Participants With Threshold Vital Signs at Baseline and Any Time Post-baseline|Threshold vital signs are defined as follows: < 80 mmHg or > 165 mmHg for systolic blood pressure; < 40 mmHg or > 105 mm Hg for diastolic blood pressure, < 40 beats per minute (bpm) or > 100 bpm for heart rate.|Baseline; up to 28 months|ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one vital sign parameter were excluded from this analysis (6 in placebo arm, 4 in dutasteride arm).|||participants|||Number
1243069|NCT00558363|Secondary|Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline|Participants underwent a digital rectal examination to evaluate for focal abnormality of the prostate.|Baseline; up to 28 months|ITT Population|||participants|||Number
1243070|NCT00558363|Secondary|Number of Participants With Nipple Tenderness (NT) at Baseline (BL) and Any Time Post-baseline|Participants underwent clinical examination of the breasts, to evaluate for nipple tenderness. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.|Baseline; up to 28 months|ITT Population. Only those participants with NT at baseline or NT at any time post-baseline were measured for clinical significance.|||participants|||Number
1243071|NCT00558363|Secondary|Number of Participants With Palpable Breast Tissue (PBT) at Baseline (BL) and Any Time Post-baseline|Participants underwent clinical examination of the breasts, to evaluate for palpable breast tissue. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.|Baseline; up to 28 months|ITT Population. Only those participants with PBT at baseline or PBT at any time post-baseline were measured for clinical significance.|||participants|||Number
1243072|NCT00558363|Secondary|Number of Participants With a Threshold Laboratory Value for Any Parameter at Baseline (BL) and Any Time Post-baseline|Threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory’s normal range, pre-specified in the analysis plan. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal range is considered a low threshold value.|Baseline; up to 28 months|ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one laboratory parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).|||participants|||Number
1243073|NCT00558363|Secondary|Number of Participants With a Shift From Normal at Baseline to at Least One Abnormal Laboratory Value for Any Parameter Any Time During the Study|A participant has a normal value for a laboratory parameter if the value is within the low and high range of normal provided by the laboratory. Each laboratory parameter is evaluated for shift from normal at baseline to abnormal any time post-baseline. A participant with any laboratory parameter showing this shift is counted. A participant is counted only once even if he had such a shift in more than one laboratory parameter or more than once among all post-baseline evaluations.|Baseline; up to 28 months|ITT Population. Participants not having any baseline measurements, or having a baseline but no post-baseline measurements of at least one of the same parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).|||participants|||Number
1243074|NCT00558363|Secondary|Changes From Baseline in Disease-related Anxiety Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)|MAX-PC is an 18-item, self-reported measure that evaluates prostate cancer-related anxiety. The score ranges from 0 to 54, and an increase in the score indicates a worsened anxiety level. Change from Baseline at Month X = Month X MAX-PC score - Baseline MAX-PC score. A missing post-baseline value is replaced by the last available post-baseline value (Last Observation Carried Forward(LOCF)). A general linear model controls for previous therapy, site cluster, and baseline MAX-PC score.|Baseline; Months 3, 6, 12, 18, and 24|ITT Population. Participants not having a baseline value or not having any post-baseline value could not be evaluated for this endpoint and were hence excluded from this analysis (3 in placebo arm, 4 in dutasteride arm). Participants were excluded from a specific visit analysis if the value for the visit (after LOCF application) was missing.|||scores on a scale||Standard Error|Least Squares Mean
1243199|NCT00557505|Other Pre-specified|Human Anti-Human Antibody (HAHA) Levels|HAHA are indicators of immunogenicity to PF-03732010.|Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal|Data was not analyzed, as development of the compound was terminated.|||microgram/mL||Standard Deviation|Mean
1243075|NCT00558363|Secondary|Number of Participants With the Indicated Change in PSA Doubling Time (PSADT) From Baseline at Month 12, Month 24, and End-of-treatment (up to 28 Months)|Participants with improvement included those whose PSADT at a specified visit was positive but more than the baseline PSADT, whose PSA at the visit was the same as the baseline PSA, or whose PSA at the visit was less than the baseline PSA. Participants with worsening included those whose PSADT at the visit was positive but less than the baseline PSADT.|Baseline; Month 12, Month 24, End-of-Treatment (up to 28 months)|ITT Population. Participants having no baseline (BL) PSADT (due to incomplete PSA data or no rise in PSA at BL) or no post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 3 in dutasteride arm). Participants with missing PSA data at a specific visit were excluded from that visit’s analysis .|||participants|||Number
1243076|NCT00558363|Secondary|Percent Change in PSA From Nadir PSA at Months 12 and 24|Percent change from nadir PSA at Month X = 100*(Month X PSA – nadir PSA)/Nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||percent change||Standard Deviation|Mean
1243077|NCT00558363|Secondary|Change in PSA From Nadir PSA at Months 12 and 24|Change from nadir PSA at Month X = Month X PSA – nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||ng/ml||Standard Deviation|Mean
1243078|NCT00558363|Primary|Number of Participants With PSA Doubling From Baseline During Year 1|PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.|up to 16 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
1243079|NCT00558363|Primary|Time to PSA Doubling From Baseline (in Days) Within Year 1|Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.|up to 16 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Only participants with PSA doubling within Year 1 (50 in placebo, 15 in dutasteride) contributed to summary statistics.|||days||Full Range|Median
1243080|NCT00558363|Primary|Number of Participants With PSA Doubling From Baseline|PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
1243081|NCT00558363|Secondary|Percent Change in Total PSA From Baseline at Months 12 and 24|Percent change in PSA from baseline at Month X = 100*(Month X PSA - Baseline PSA)/Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||percent change||Standard Deviation|Mean
1243082|NCT00558363|Secondary|Change in Total PSA From Baseline at Months 12 and 24|Change in PSA from baseline at Month X = Month X PSA - Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||nanograms/milliliter (ng/ml)||Standard Deviation|Mean
1243083|NCT00558363|Secondary|Number of Participants With PSA Progression|A participant was designated as having a PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was (>10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy) and PSA >=1.5 times the baseline PSA value), or 0<PSADT<=91 days, and all subsequent PSA values satisfied either of these criteria.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
1243109|NCT00558272|Secondary|Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in NTx/Cr||95% Confidence Interval|Geometric Mean
1243084|NCT00558363|Secondary|Time to PSA Progression (in Days)|A participant was designated as having PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy and PSA >=1.5 times the baseline PSA value, or 0<PSADT<=91 days, and all subsequent PSA values satisfied these criteria. The study day for the first PSA qualifying for progression was used for time to PSA progression. If none of the PSA values qualified for PSA progression, time to PSA progression was censored at the last post-baseline PSA evaluation.|up to 28 months|ITT Population. Only those participants with PSA progression have been summarized.|||days||Full Range|Median
1243085|NCT00558363|Secondary|Number of Participants With a PSA Rise From Baseline|A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
1243086|NCT00558363|Secondary|Time to PSA Rise From Baseline (in Days)|A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value. The study day for the first PSA evaluation that qualified for analysis of PSA rise was used for time to PSA rise. If none of the post-baseline PSA values qualified for analysis of PSA rise during the study, time to PSA rise was censored at the last post-baseline PSA evaluation.|up to 28 months|ITT Population. Only those participants with PSA rise have been summarized.|||days||Full Range|Median
1243087|NCT00558363|Secondary|Number of Participants Classified as Treatment Responders at Months 3, 6, 9, 12, 15, 18, 21, and 24|Treatment responders at Month X were defined as participants (par.) with either a PSA decrease or an increase <=15% from baseline to Month X confirmed in all PSA measurements between baseline (BL) and Month X.|Months 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Par. not having a post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Different par. may contribute data at different time points (TP); the number of par. analyzed at each TP are those with BL as well as post-baseline data at the particular TP.|||participants|||Number
1243088|NCT00558363|Secondary|Number of Participants With Disease Progression|Disease progression is defined as the first occurrence of any of the following: PSADT<=91 days, PSA value is at least 50% more than baseline value (>20 ng/ml for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. If one of the PSA criteria is qualifying (within treatment period, typically up to 24-month evaluations), an immediate subsequent PSA, if available, must confirm either criterion (or at least 85% of the qualifying value).|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
1243089|NCT00558363|Secondary|Time to Disease Progression From Baseline (in Days)|Time to disease progression is defined as the number of days between baseline and the first occurrence of any of the following: PSA doubling time (PSADT)<=91 days, PSA value is at least 50% more than baseline value (>20 nanogram/milliliter [ng/ml] for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. (Confirmation of PSA criteria is required in an immediate subsequent PSA, if available, and PSA values for consideration are restricted to treatment period, typically up to 24-month evaluations.)|up to 28 months|ITT Population. Only those participants with disease progression have been summarized.|||days||Full Range|Median
1243090|NCT00558363|Primary|Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)|Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.|up to 28 months|ITT Population: all participants randomized to study treatment. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm; 1 in dutasteride arm). Only participants who experienced PSA doubling (82 in placebo, 41 in dutasteride) contributed to summary statistics.|||days||Full Range|Median
1243091|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 14|The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.|Baseline, Day 14|Safety Population includes all patients who received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
1243092|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 7|The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.|Baseline, Day 7|Safety Population includes all patients who received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
1243093|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 1|The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.|Baseline, Day 1|Safety Population includes all patients who received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
1243094|NCT00558285|Secondary|Trough Forced Vital Capacity (FVC) at Day 1 and Day 14|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.|Day 1 and Day 14|Participants from the Intent-to-treat Population (all randomized patients) with data available at the given time-point. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.|||Liters||Standard Error|Least Squares Mean
1243095|NCT00558285|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.|Day 1, Day 14|Intent-to-treat Population includes all randomized patients. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.|||Liters||Standard Error|Least Squares Mean
1243096|NCT00558285|Secondary|Change From Baseline in Mean 24 Hour Heart Rate at Day 1|Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.|Baseline, Day 1|Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.|||beats per minute||Standard Error|Least Squares Mean
1243097|NCT00558285|Primary|Change From Baseline in Mean 24 Hour Heart Rate at Day 14|Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.|Baseline, Day 14|Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.|||beats per minute||Standard Error|Least Squares Mean
1243098|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||h||Full Range|Median
1243099|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||Ratio||Full Range|Median
1243100|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng/ml||Full Range|Median
1243101|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng/ml||Full Range|Median
1243102|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng.h/ml||Full Range|Median
1243103|NCT00558272|Secondary|Saracatinib: Time to Cssmax (Tmax)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||h||Full Range|Median
1243104|NCT00558272|Secondary|Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng/ml||Full Range|Median
1243105|NCT00558272|Secondary|Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng/ml||Full Range|Median
1243106|NCT00558272|Secondary|Saracatinib: Plasma Clearance at Steady State (CLss/F)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||L/h||Full Range|Median
1243107|NCT00558272|Secondary|Saracatinib: Area Under the Curve at Steady State (AUCss)|Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.|Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng•hr/ml||Full Range|Median
1243108|NCT00558272|Secondary|Percentage Change From Baseline in Urine Alpha-alpha C-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (aaCTx/Cr) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in aaCTx/Cr||95% Confidence Interval|Geometric Mean
1243264|NCT00557284|Secondary|Mean Change in Serum IgE Levels|Mean change in serum levels of IgE from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm.|Baseline and 9 weeks||||kU/L||Standard Deviation|Mean
1243110|NCT00558272|Secondary|Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in TRAP5b||95% Confidence Interval|Geometric Mean
1243111|NCT00558272|Secondary|Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in PINP||95% Confidence Interval|Geometric Mean
1243112|NCT00558272|Secondary|Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in ICTP||95% Confidence Interval|Geometric Mean
1243113|NCT00558272|Secondary|Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in bALP||95% Confidence Interval|Geometric Mean
1243114|NCT00558272|Primary|Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in betaCTX||95% Confidence Interval|Geometric Mean
1243115|NCT00558259|Secondary|Laboratory Measures, Especially Liver Function Tests (LFTs)|Number of participants with possible clinically significant abnormalities during the treatment period.|6 months|FAS − As Treated Assignment|||participants|||Number
1243116|NCT00558259|Secondary|Centrally Confirmed Cardiovascular Events During the Treatment Period|Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.|6 months|FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.|||participants|||Number
1243117|NCT00558259|Secondary|Centrally Confirmed Bleeding Event During the Treatment Period|"Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:~Fatal bleeding~Associated with a fall in haemoglobin of ≥2 g/dL~Led to the transfusion of ≥2 units packed cells or whole blood~Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal~Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.~Examples of these bleedings were:~Bleeding that compromised haemodynamics~Bleeding that led to hospitalisation~Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.~All bleeding events include MBEs, CRBEs, and trivial bleeding events."|6 months|FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.|||participants|||Number
1243118|NCT00558259|Secondary|Centrally Confirmed Unexplained Deaths During the Intended Treatment Period|Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.|6 months|FAS and analysed as randomised.|||participants|||Number
1243119|NCT00558259|Secondary|Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period|Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.|6 months|FAS and analysed as randomised.|||Participants|||Number
1243120|NCT00558259|Secondary|Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period|Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.|6 months|FAS and analysed as randomised.|||Participants|||Number
1243121|NCT00558259|Secondary|Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period|Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.|6 months|FAS and analysed as randomised.|||Participants|||Number
1243122|NCT00558259|Primary|Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period|Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.|6 months|Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated.|||Participants|||Number
1243123|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|12 months|There were 59 participants who completed all follow-up visits and cosmetic evaluations.|||Incisions with good outcome|||Number
1243124|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|6 months|There were 60 participants who completed all follow-up visits and cosmetic evaluations.|||Incisions with good outcome|||Number
1243125|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|90 days post-procedure|There were 60 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.|||Incisions with good outcome|||Number
1243126|NCT00558246|Secondary|Time (Minutes) Required to Close the Final Skin Layer|Overall time required to close final skin layer on each breast.|Intraoperative|The analysis is based upon the Intent to Treat population.|||minutes||Standard Deviation|Mean
1243127|NCT00558246|Primary|Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.|Equivalence was demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) did not exceed 12 percent.|12-25 days|The primary analysis is based upon intent to treat population.|||Participants|||Number
1243128|NCT00558103|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks|mITT1 and mITT2 Populations|||months||90% Confidence Interval|Median
1243129|NCT00558103|Secondary|Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease)|RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks|mITT1 and mITT2 Populations|||weeks||90% Confidence Interval|Median
1243130|NCT00558103|Secondary|Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression|RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks|mITT1 and mITT2 Populations. Only participants who achieved a response of CR or PR during the study were analyzed. For participants who did not progress or die, duration of response was censored on the date of the last adequate assessment.|||weeks||90% Confidence Interval|Median
1243131|NCT00558103|Primary|Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions|RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks|Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study treatment. The mITT1 Population was used for cohort 1; the mITT2 Population used for cohort 2.|||participants|||Number
1243132|NCT00558064|Secondary|Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG|Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of randomised treatment to 24 hours post last dose of randomised treatment|Treated set: Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or A5 during the double-blind treatment period.|||participants|||Number
1243146|NCT00558025|Secondary|Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Score on scale||Standard Error|Least Squares Mean
1243133|NCT00558064|Secondary|Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)|"Optimal, normal, high normal blood pressure were defined as follows:~Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg~Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg~High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg~No: SBP >= 140 mmHg and DPB >= 90 mmHg"|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
1243134|NCT00558064|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks|Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
1243135|NCT00558064|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
1243136|NCT00558064|Secondary|Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
1243137|NCT00558064|Secondary|Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
1243138|NCT00558064|Secondary|Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||mmHg||Standard Error|Mean
1243139|NCT00558064|Primary|Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||mmHg||Standard Error|Mean
1243140|NCT00558025|Secondary|Final Pramipexole Dose (mg) After 9 Weeks, Treated Set|The mean final daily Pramipexole dose is displayed|Week 9|Treated Set (TS) includes all patients randomized and who received treatment|||mg||Standard Deviation|Mean
1243141|NCT00558025|Secondary|Pramipexole Dose Adaptation, FAS (LOCF)|Patients with increase in daily Pramipexole dose on FAS|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||participants|||Number
1243142|NCT00558025|Secondary|Patient Global Impression - Improvement (PGI-I), FAS (LOCF)|Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||participants|||Number
1243143|NCT00558025|Secondary|Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)|Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||participants|||Number
1243144|NCT00558025|Secondary|Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Score on Scale||Standard Error|Least Squares Mean
1243145|NCT00558025|Secondary|Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Score on Scale||Standard Error|Mean
1243265|NCT00557284|Secondary|Mean Change in Serum and Urinary Inflammatory Marker Levels|Mean change in levels from baseline to study visit 4 (week 1 compared to week 9)for interleukin 3 (IL3), tumor necrosis factor alpha (TNF alpha), nerve growth factor (NGF), and urinary leukotriene E4 (LTE4)|Baseline and 9 weeks||||pg/ml||Standard Deviation|Mean
1243147|NCT00558025|Secondary|Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)|A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).|from baseline to week 4|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Percentage of participants|||Number
1243148|NCT00558025|Primary|Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)|A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)|from baseline to week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Percentage of participants|||Number
1243149|NCT00558012|Primary|Bone Mineral Density (BMD) of the Total Hip and Spine|BMD is the bone mineral density of the lumbar spine and total hip measured using dual-energy xray absorptiometry (DXA) scan|Baseline, 12 months, 24 month|Number of patients that completed a DXA at 12 months. At 24 months 60 in active treatment group and 72 in placebo group completed a DXA.|||Percent change||Standard Error|Mean
1243150|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|12 month|There were 49 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.|||Incisions with good outcome|||Number
1243151|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|6 months|There were 50 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.|||Incisions with good outcomes|||Number
1243152|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|90 days post-procedure|There were 50 participants who consented to and ultimately attended follow-up visits for evaluation of cosmetic outcome.|||Incisions with good outcome|||Number
1243153|NCT00557947|Secondary|Time Required to Close the Final Skin Layer|Time to close final skin layer for each incision segment.|Intraoperative|The analysis is based upon the Intent To Treat population|||minutes||Standard Deviation|Mean
1243154|NCT00557947|Primary|Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|12-25 days post-operation|The primary analysis is based upon intent to treat population.|||Participants|||Number
1243155|NCT00557856|Other Pre-specified|Circulating Endothelial Cells (CEC)and Circulating Endothelial Progenitors (CEP): Part 1 and Part 2|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Data was reported in individual participant listings but not statistically summarized due to statistical constraints.||||||
1243156|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble Protein Biomarker Analysis Set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||pg/ml||Standard Deviation|Mean
1243157|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||pg/ml||Standard Deviation|Mean
1243158|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||pg/ml||Standard Deviation|Mean
1243159|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2|Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||pg/ml||Standard Deviation|Mean
1243160|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1243161|NCT00557856|Other Pre-specified|Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 2|HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (>=4.32).|Baseline up to 3 months after last dose|Statistical Data was not statistically summarized as majority of participants had concentration below the limit of quantification.||||||
1243162|NCT00557856|Other Pre-specified|Plasma Decay Half-Life (t1/2): Part 1 and Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||hours||Standard Deviation|Mean
1243163|NCT00557856|Secondary|Volume of Distribution: Part 1 and Part 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||liter (L)||Standard Deviation|Geometric Mean
1243164|NCT00557856|Other Pre-specified|Systemic Clearance(CL): Part 1 and Part 2|CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||liter/hour (L/hr)||Standard Deviation|Geometric Mean
1243165|NCT00557856|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
1243166|NCT00557856|Other Pre-specified|Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2|AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28).|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1243167|NCT00557856|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2||0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||hour||Full Range|Median
1243168|NCT00557856|Other Pre-specified|Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2||0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure and “n” signifies those participants who were evaluable at specific time-point.|||ng/mL||Standard Deviation|Geometric Mean
1243169|NCT00557856|Other Pre-specified|Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2||0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962.|||nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
1243170|NCT00557856|Secondary|Time To Progression (TTP): Part 2|Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST). PD: >=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of >=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Safety population included all participants who received at least one dose of study drug.|||months||Full Range|Median
1243171|NCT00557856|Secondary|Percentage of Participants With Disease Control: Part 2|Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment.|||percentage of participants||90% Confidence Interval|Number
1243172|NCT00557856|Secondary|Percentage of Participants With Objective Response: Part 1 and Part 2|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment.|||percentage of participants||90% Confidence Interval|Number
1243173|NCT00557856|Secondary|Number of Participants With Laboratory Abnormalities: Part 1 and Part 2|Laboratory tests included hematology (hemoglobin, lymphocytes absolute [abs], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute [NCI] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 [mild AE: did not cause any significant problem, no dose adjustment required]; grade 2 [moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event]; grade 3 [severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event] and grade 4 [life threatening AE]). Overall data of the 4 grades is reported.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1243174|NCT00557856|Secondary|Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2|Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned.||||||
1243175|NCT00557856|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1243186|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CGI (Clinical Global Impression) Severity of Illness Scores at Weeks 2, 4, 6, 8, 10, and 12|The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill patients.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
1243176|NCT00557856|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1243177|NCT00557856|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2|An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1243178|NCT00557856|Primary|Recommended Phase 2 Dose (RP2D): Part 1|RP2D was defined as the lower dose level to MTD based on the safety profile.|Baseline up to 42 days after the start of each increased treatment dose|The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.|||mg/kg|||Number
1243179|NCT00557856|Primary|Maximum Tolerated Dose (MTD): Part 1|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).|Baseline up to 42 days after the start of each increased treatment dose|The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.|||milligram/kilogram (mg/kg)|||Number
1243180|NCT00557830|Post-Hoc|Median Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. The median progression free survival is the parameter used to describe PFS.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever occurred first||||Months||95% Confidence Interval|Median
1243181|NCT00557830|Secondary|Changes From Baseline in Symptom Burden|"The Patient Care Monitor Version 2.0 (PCM) is an tablet computer based assessment system that measures patient reported outcomes (PROs) in medical patients with a particular emphasis on symptoms related to cancer and its treatment.~The PCM comprises 86 items which include 8 items answered only by females (e.g. menstrual cramping). Each item is presented so that the patient rates the degree to which the item has been a problem in the past week (0 not a problem to 10 as bad as possible)."|The PCM was administered during screening, at each scheduled visit (approximately every 4 weeks), and at the end of treatment visit.||||units on a scale||Standard Deviation|Mean
1243182|NCT00557830|Secondary|Overall Survival Rate|Due to the early study closure and the small sample size, overall survival rate was not evaluated.|Overall survival was measured from day 1 of treatment until the end of treatment and then every 4 months thereafter until death.|Due to the early study closure and the small sample size, overall survival rate was not evaluated.||||||
1243183|NCT00557830|Secondary|PFS Rate at 9, 13 and 17 Months|Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.|PFS was to be measured at 9, 13, and 17 months.|Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.||||||
1243184|NCT00557830|Primary|Overall Response Rate (CR + PR) Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Response was evaluated via changes from baseline in radiological tumor measurements performed every 8 weeks and at the end of treatment unless clinically indicated prior to that. Confirmatory scans were to be obtained no less than 4 weeks but no more than 6 weeks following initial documentation of objective response. Response was evaluated using RECIST criteria, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions or the appearance of one or more new lesions.|Overall response will be measured at baseline and every 8 weeks , unless clinically indicated prior to that, until the end of treatment.||||Participants|||Number
1243185|NCT00557622|Secondary|Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12|The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1,Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse.|Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
1243195|NCT00557505|Other Pre-specified|Change From Baseline in Leucocyte Subtypes||Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal|Data was not analyzed, as development of the compound was terminated.|||cells/mL|||Number
1248045|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 16 weeks||||liters||Standard Error|Least Squares Mean
1243187|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Increased Arousal Symptom at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
1243188|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Avoidance and Numbing at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
1243189|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Re-experiencing at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
1243190|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Total Score at Weeks 4 and 8|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4 and 8|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
1243191|NCT00557622|Secondary|Number of Participants With the Indicated Week 0 and Week 12 Z-scores for Regional Blood Flow Using Functional Magnetic Resonance Imaging (fMRI) in the Left Amygdala (LA), Right Amygdala (RA), and the Medial Prefrontal Cortex (MPFC)|Change in regional blood flow (rCBF) measured by fMRI represents altered neuronal responses in PTSD patients and is considered to be the biomarker for treatment response. fMRI measures are provided as blood oxygeneration level-dependent (BOLD) signals (z-score). To trigger neuronal activation, 2 visual stimuli were used: MVA-task (consisting of MVA-related and unpleasant pictures) and face-task (consisting of a variety of facial expressions [e.g., neutral, happy, fear]). Week 0 and 12 rCBF data from 1 participant were invalid (involuntary movement in the fMRI machine); no analysis was done.|Baseline and Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
1243192|NCT00557622|Primary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale One Week Symptom Status Version) Total Score at Week 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
1243193|NCT00557505|Other Pre-specified|Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC)||Baseline and cycle 3|Data was not analyzed, as development of the compound was terminated.|||pg/mL||Standard Deviation|Mean
1243194|NCT00557505|Other Pre-specified|Change From Baseline in Cytokine Concentration||Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1|Data was not analyzed, as development of the compound was terminated.|||picogram (pg)/mL||Standard Deviation|Mean
1243200|NCT00557505|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37|Data was not analyzed, as antitumor activity was not observed.|||participants|||Number
1243201|NCT00557505|Secondary|Apparent Volume of Distribution (Vd)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||Liter||Standard Deviation|Geometric Mean
1243202|NCT00557505|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||Liter/hr||Standard Deviation|Geometric Mean
1243203|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||ng*hr/mL||Standard Deviation|Geometric Mean
1243204|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]|AUC (0-14)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-14 day).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||ng*hr/mL||Standard Deviation|Geometric Mean
1243205|NCT00557505|Secondary|Maximum Observed Serum Concentration (Cmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||ng/mL||Standard Deviation|Geometric Mean
1243206|NCT00557505|Secondary|Minimum Observed Serum Trough Concentration (Cmin)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||ng/mL||Standard Deviation|Geometric Mean
1243207|NCT00557505|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||hr||Full Range|Median
1243208|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]|AUC (0-28 day)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28 day).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1243209|NCT00557505|Primary|Recommended Phase-2 Dose (RP2D)||Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle|Data was not analyzed, as development of the compound was terminated.|||mg/kg|||Number
1243210|NCT00557505|Primary|Maximum Tolerated Dose (MTD)||Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle|MTD analysis population included all participants enrolled in the dose escalation part of the study who received at least 1 dose of study medication.|||mg/kg|||Number
1243211|NCT00557492|Secondary|Ca 19-9 Level (in Serum) - Biomarker Response|Percentage decrease in Ca 19-9 level (in serum)|Baseline and up to 48 months|Participants that did NOT demonstrate metastatic progression upon restaging CT.|||percentage decrease in serum Ca19-9 leve||Standard Deviation|Mean
1243212|NCT00557492|Secondary|Radiographic Tumor Response|CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)|Up to 48 months||||Participants|||Number
1243213|NCT00557492|Secondary|Rate of Surgical Resection|Number of participants that underwent resection / per the total number of evaluable participants|Up to 48 months||||percentage of participants|||Number
1243214|NCT00557492|Secondary|Progression-free Survival (PFS)||Up to 48 months|Includes participants who underwent laparoscopy and pancreatic resection.|||months||95% Confidence Interval|Median
1243215|NCT00557492|Secondary|Progression-free Survival (PFS)||Up to 48 months|Includes entire study cohort.|||months||95% Confidence Interval|Median
1243216|NCT00557492|Secondary|Overall Survival (OS)||Up to 48 months|Includes participants who underwent laparoscopy and pancreatic resection.|||months||95% Confidence Interval|Number
1243217|NCT00557492|Secondary|Overall Survival (OS)||Up to 48 months|Includes entire study cohort.|||months||95% Confidence Interval|Number
1248046|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 8 weeks||||liters||Standard Error|Least Squares Mean
1243218|NCT00557492|Primary|Rate of Pathologic Complete Response (pCR)|Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.|Up to 48 months|Participants who underwent laparoscopy and pancreatic resections.|||percentage of participants||95% Confidence Interval|Number
1243219|NCT00557492|Primary|Rate of Margin Negative Surgical Resection (R0 Resection Rate)|Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.|Up to 48 months|Participants who underwent laparoscopy and pancreatic resection.|||percentage of participants||95% Confidence Interval|Number
1243220|NCT00557466|Secondary|Number of Participants Using Rescue Medication|Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.|Over 14 days|Intent to treat|||participants|||Number
1243221|NCT00557466|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow|The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.|Baseline (recorded during the screening period) and Days 1-14 (treatment period).|Intent to treat population. The analysis only includes patients with non-missing data.|||liters/minute||Standard Deviation|Mean
1243222|NCT00557466|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.|Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose|"The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by N."|||minutes||Standard Deviation|Mean
1243223|NCT00557466|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1|FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.|||liters||Standard Error|Least Squares Mean
1243224|NCT00557466|Secondary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1 Baseline (prior to first dose) and 24 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.|||liters||Standard Error|Least Squares Mean
1243225|NCT00557466|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose|FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.|||liters||Standard Error|Least Squares Mean
1243226|NCT00557466|Primary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Baseline (prior to first dose) and Day 15 (24 hours after last dose)|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.|||liters||Standard Error|Least Squares Mean
1243227|NCT00557440|Secondary|Forced Vital Capacity (FVC) at Single Time Points|"Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.~FVC was analyzed using ANCOVA adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect."|5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.|||liters||Standard Error|Least Squares Mean
1243228|NCT00557440|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1 during the first 4 hours post-dose.~Time to peak FEV1 is based on log-transformed analysis of variance adjusted for treatment, period, sequence and center, with patient nested within sequence as a random effect. Geometric Mean was obtained by taking anti-logs of the adjusted means from the model and standard error was calculated using the delta method."|Up to 4 hours post-dose|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis.|||minutes||Standard Error|Geometric Mean
1243229|NCT00557440|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was measured pre-dose and up to 24 hours post-dose. The FEV1 standardized area under the curve (AUC) was analyzed for four time intervals:~Baseline (pre-dose) to 4 hours (hr) post-dosing;~Baseline (pre-dose) to 23 hours, 45 minutes (min) post-dosing;~11 hours, 10 minutes to 12 hours, 30 minutes post-dosing;~11 hours, 10 minutes to 23 hours, 45 minutes post-dosing.~AUC for FEV1 was analyzed using Analysis of Covariance adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect."|Pre-dose, 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.|||liters||Standard Error|Least Squares Mean
1243230|NCT00557440|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.|5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.|||liters||Standard Error|Least Squares Mean
1243231|NCT00557440|Primary|Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|The Intent-To-Treat (ITT) population included all randomized patients who had at least one period containing a Baseline FEV1 measurement and at least one post-baseline measurement of FEV1 for the same treatment period. Patients who took rescue medication within 6 hours prior to the trough measurements were excluded from the analysis.|||liters||Standard Error|Least Squares Mean
1243232|NCT00557362|Secondary|Best Hard Contact Lens-corrected Visual Acuity 3 Months After Enrollment in a Multiple Linear Regression Model With Enrollment Hard Contact Lens-corrected Visual Acuity as a Covariate|Best hard contact lens-corrected visual acuity 3 months after enrollment was evaluated in a multiple linear regression model with enrollment hard contact lens-corrected visual acuity as a covariate. Visual acuity is reported in logMAR (logarithm of the Minimum Angle of Resolution).|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
1243233|NCT00557362|Secondary|Subgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp).|Two subgroup analyses were conducted by causative organism: 1) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Fusarium ulcers; 2) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Aspergillus ulcers.|3 months from enrollment|This analysis looks at two different subgroups - Fusarium ulcers and Aspergillus ulcers. There were 44 Fusaruim ulcers enrolled in this trial and analyzed here, 23 of which were randomized to voriconazole and 21 to natamycin. There were 19 Aspergillus ulcers analyzed here, 8 of which were randomized to voriconazole and 11 to natamycin.|||logMAR||95% Confidence Interval|Mean
1243234|NCT00557362|Secondary|Size of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate.|Size of infiltrate/scar post-treatment was analyzed in a linear regression model using enrollment infiltrate/scar size as a covariate. No differentiation was made between infiltrate and scar when measuring infiltrate/scar size (measured in mm). For analysis, infiltrate/scar size was characterized by the geometric mean of the longest dimension and the longest perpendicular.|3 months from enrollment||||mm||95% Confidence Interval|Mean
1243235|NCT00557362|Secondary|Time to Resolution of Epithelial Defect|Resolution of epithelial defect was defined as the absence of an epithelial defect with administration of fluorescein. The time to re-epithelialization was compared between the voriconazole and natamycin groups using the Cox proportional hazards model, adjusting for baseline epithelial defect size.|3 months from enrollment||||days||Standard Deviation|Mean
1243236|NCT00557362|Primary|Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model|The primary efficacy endpoint was BSCVA at 3 months in the study eye, using a linear regression model with 3-month BSCVA measured in logMAR (logarithm of the Minimum Angle of Resolution) as the outcome variable and treatment arm (voriconazole vs natamycin) and enrollment logMAR BSCVA and corneal de-epithelialization (yes or no) as covariates.|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
1243237|NCT00557349|Secondary|Number of Participants With Upper Endoscopy Indicated Due to Complaints|Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints|during first 14 weeks after surgery|Patients lost to follow-up were not included in the study analysis.|||participants|||Number
1243238|NCT00557349|Primary|Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.||during first 14 weeks after surgery|Patients lost to follow-up were not included in the data analysis.|||participants|||Number
1243239|NCT00557323|Secondary|Number of Study-emergent Deaths||5 years|Safety Set|||Participants|||Number
1243240|NCT00557323|Primary|Number of Study-emergent Bone-related Adverse Events (AEs)||5 years|Safety Set defined as all subjects who received at least one safety measurement during the study.|||Bone-related AEs|||Number
1243412|NCT00556491|Primary|Development of Post-operative Acute Kidney Injury|Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively|up to 5 days post cardiac surgery||||participants meeting primary oputcome|||Number
1243241|NCT00557310|Secondary|Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint|CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of nanogram/milliliter (ng/mL)||Standard Error|Least Squares Mean
1243242|NCT00557310|Secondary|Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint|PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of microgram/Liter (µg/L)||Standard Error|Least Squares Mean
1243243|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/cm²||Standard Error|Least Squares Mean
1243244|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/cm²||Standard Error|Least Squares Mean
1243245|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/cm²||Standard Error|Least Squares Mean
1243246|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/cm²||Standard Error|Least Squares Mean
1243247|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/square centimeter (g/cm²)||Standard Error|Least Squares Mean
1243248|NCT00557310|Secondary|Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint|Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of Newtons||Standard Error|Least Squares Mean
1243249|NCT00557310|Secondary|Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint|Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of Newtons||Standard Error|Least Squares Mean
1243250|NCT00557310|Secondary|Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint|Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of mg/cm³||Standard Error|Least Squares Mean
1243251|NCT00557310|Secondary|Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint|Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of mg/cm³||Standard Error|Least Squares Mean
1243280|NCT00557193|Secondary|Minimal Residual Disease (MRD) Assessed by Multiparameter Flow Cytometry|MRD results will be categorized and summarized by treatment arm. Correlation between multiparameter flow cytometry MRD assessments and EFS outcome will be described in this population. Three-year EFS estimates will be reported by treatment arm.|At 3 years||2019-03-31|03/2019||||
1243252|NCT00557310|Secondary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 12, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of ratio||Standard Error|Least Squares Mean
1243253|NCT00557310|Secondary|Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint|BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of ratio||Standard Error|Least Squares Mean
1243254|NCT00557310|Secondary|Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint|TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of ratio||Standard Error|Least Squares Mean
1243255|NCT00557310|Secondary|Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint|Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of millimeter (mm)||Standard Error|Least Squares Mean
1243256|NCT00557310|Secondary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of ratio||Standard Error|Least Squares Mean
1243257|NCT00557310|Primary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||percent (%) change of ratio||Standard Error|Least Squares Mean
1243258|NCT00557284|Secondary|Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS|The mean change from baseline to study visit 4 (week 1 compared to week 9) in GRGS scores (GI symptoms will be recorded on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease) for all subjects in each arm.This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 for each point (0 being no complaint and 3 being most severe for a maximum total of 21).|Baseline and 9 weeks||||units on a scale||Standard Deviation|Mean
1243259|NCT00557284|Primary|Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream|Average of weekly use of cetirizine and/or 10% hydrocortisone cream will be compared for all subjects in each arm from week 1 to week 9. Flare-up is defined as a worsening of the disease that is unacceptable to the participants and leads to second line topical steroid use and/or liquid anti-histamine use. Measurement is noted as 1 for daily use (does not correspond to multiple uses per day).|Baseline and 9 weeks||||days/week||Standard Deviation|Mean
1243260|NCT00557284|Primary|Mean Change in Pruritus|Mean change in pruritus scores from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Pruritus assessments (“itch”) will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Scores are cumulative per week.|Baseline and 9 weeks||||units on a scale||Standard Deviation|Mean
1243261|NCT00557284|Primary|Mean Change in PADC (Caregivers Perception of Disease Control)|Mean change in PADC from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Caregiver’s evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3)|Baseline and 9 weeks||||units on a scale||Standard Deviation|Mean
1243262|NCT00557284|Primary|Mean Change in Investigator Global Assessment (IGA)|The mean change in IGA from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. The IGA is a six-point measure of disease severity and is evaluated by the investigator based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe.|Baseline and 9 weeks||||units on a scale||Standard Deviation|Mean
1243263|NCT00557284|Primary|Change in Percentage of Body Involvement|Change in percentage of body involvement from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm for AD as measured by study investigator|Baseline and 9 weeks||||Change of percentage in body involvement||Standard Deviation|Mean
1243266|NCT00557245|Secondary|Head Circumference Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up|||z-score difference per study month|||Number
1243267|NCT00557245|Secondary|Weight Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up|||z-score difference per study month|||Number
1243268|NCT00557245|Secondary|Length Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up|||z-score difference per study month|||Number
1243269|NCT00557245|Secondary|Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.|Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.|Up to 36 months|Randomized female participants, less those found to be ineligible (n=7)|||Number of live-born infants|Participants||Number
1243270|NCT00557245|Secondary|Prevalence of Unprotected Sex During Follow-up|Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.|Up to 36 months|All randomized participants, less those found to be ineligible (n=11).|||percentage of visits|||Number
1243271|NCT00557245|Secondary|Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up|"Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.~N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics)."|Up to 36 months|Randomized participants, less those found to be ineligible (n=11)|||participants|||Number
1243272|NCT00557245|Secondary|Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC|"HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.~Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1)."|Up to 36 months|Participants who seroconverted during the Partners PrEP trial, including those who were retrospectively found to be HIV infected at enrollment (TDF arm: n=5; FTC-TDF arm: n=3; placebo arm: n=6). For 4 of 96 HIV-1 seroconverters (TDF arm: n=2; FTC-TDF arm: n=1; placebo arm: n=1) HIV-1 RNA was unable to be amplified for HIV-1 resistance testing.|||Participants|||Number
1243273|NCT00557245|Secondary|Study Drug Adherence: Self-reported Missed Doses of Study Drug|Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.|Up to 36 months|Participants with self-reported adherence.|||percentage of visits|||Number
1243274|NCT00557245|Secondary|Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.|Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.|Up to 36 months||||percentage of doses taken of dispensed|||Number
1243275|NCT00557245|Primary|Number of Participants With Serious Adverse Events (SAEs)|Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.|Up to 36 months|Randomized participants, less those found to be ineligible (n=11)|||Participants|||Number
1243276|NCT00557245|Primary|Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants|The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.|Up to 36 months|All randomized participants, less those who were found to ineligible (n=11), less those found to be infected at enrollment (n=14), and less those who did not return for any follow-up (n=25).|||events per 100 person years||95% Confidence Interval|Number
1243277|NCT00557193|Secondary|Percent Probability for Event-free Survival (EFS) for Patients on Arm A|EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.|From start of post-induction therapy for up to 10 years|All Eligible patients treated in Arm A (standard risk MLL-G).|||percentage probability||90% Confidence Interval|Number
1243278|NCT00557193|Secondary|Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With PIA Values|Means and standard deviations of Plasma Inhibitory Activity (PIA) will be given by genotype|At 3 years|Data was and never will be collected||||||
1243279|NCT00557193|Secondary|Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With Survival Outcomes|EFS outcomes will be reported by genotype.|At 3 years|Data was and never will never be collected.||||||
1243286|NCT00557193|Secondary|Pharmacokinetic Albumin in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy|Pharmacokinetic albumin in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.|Up to 12 weeks|Data was and never will be collected||||||
1243287|NCT00557193|Secondary|Pharmacokinetic AGP Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy|Pharmacokinetic AGP levels in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.|Up to 12 weeks|Data was and never will be collected||||||
1243288|NCT00557193|Secondary|Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)|Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.|Up to 12 weeks from start of induction|Arm C patients of Safety Phase who were evaluable for DLT. The first 10 evaluable patients enrolled on each dose level were included for monitoring dose limiting toxicity.|||Participants|||Count of Participants
1243289|NCT00557193|Secondary|Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2|Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.|From start of post-induction therapy for up to 10 years.|All eligible Arm B and ARM C (Dose Level 2) patients were included in the analysis.|||percent probability||90% Confidence Interval|Number
1243290|NCT00557193|Primary|Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)|EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.|From start of post-induction therapy for up to 10 years|All 67 patients on Arm C (Safety and Efficacy at Dose Level 2) were included in the analysis.|||percentage probability||90% Confidence Interval|Number
1243291|NCT00557076|Secondary|Brainstem Auditory Evoked Potentials||End of Experimental Intervention|||||||
1243292|NCT00557076|Secondary|Functional Magnetic Resonance Imaging (fMRI)||Immediately after treatment ends|||||||
1243293|NCT00557076|Secondary|Coma Near Coma Scale|The CNC scale measures arousal and awareness and test stimuli are administered to elicit a specified behavior. Presence/absence of this behavior is scored as 0, 2 or 4. Total raw scores range from 0 (consistently responsive) to 36 (extreme coma). The CNC change score was calculated as the 8th CNC measure minus the Baseline CNC measure. Since 2 CNC measurements were collected per week, the 8th CNC measure occurred in Week 4. To calculate the change, we used the eighth CNC measure because two patients (one per group) recovered full consciousness after the eighth CNC measure. In the second statistical analysis, all CNC measures were used to calculate the slope; this includes the Baseline CNC and CNC measures 2-8. Again, we used the first 8 CNC measures (instead of all 12 collected over 6 weeks of treatment) because two patients recovered full consciousness after the eighth CNC measure.|Baseline and after the 8th CNC assessment (4 weeks after Baseline)||||units on a scale||Standard Deviation|Mean
1243294|NCT00557076|Primary|DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change|The primary outcome, the DOCS, is a reliable, valid and precise measure of global neurobehavioral functioning shown to remain stable over six weeks.The DOCS-25 starts with a systematic observation followed by administration of 25 sensory stimuli. Best responses to each stimulus are rated on a scale of 0 to 2 and total raw scores range from 0 (worst) to 50 (best). The DOCS change was calculated as the value at endpoint (6 weeks after Baseline) minus the value at Baseline.|Baseline and immediately after treatment ends (6 weeks after Baseline)||||units on a scale||Standard Deviation|Mean
1243295|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax 300 mg Oral Dose|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of oral dosing|||||||
1243296|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax Day 7 Oral All Participants|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of oral dosing|||||||
1243297|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Steady State|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of Intravenous dosing|||||||
1243298|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Loading Dose|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1|||||||
1243299|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral 300mg|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 oral dosing|||||||
1246271|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect|For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.|over 12 weeks||||percent of total effect|||Number
1243300|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral Dose All Subjects|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 Oral dosing|||||||
1243301|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Steady State|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of IV dosing|||||||
1243302|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1|||||||
1243303|NCT00556998|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1243304|NCT00556998|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1243305|NCT00556998|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1243306|NCT00556998|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Full Range|Median
1243307|NCT00556998|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1243308|NCT00556998|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1243309|NCT00556998|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.|||μg/mL||Standard Deviation|Geometric Mean
1243310|NCT00556998|Secondary|Cmax Following an IV Loading Dose||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1243311|NCT00556998|Secondary|Tmax Following an IV Loading Dose||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1243312|NCT00556998|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1243313|NCT00556998|Primary|Tmax Following Oral Administration||Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1243314|NCT00556998|Primary|Cmax,ss Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1243315|NCT00556998|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1243316|NCT00556998|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1243317|NCT00556998|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1243318|NCT00556998|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|Intent to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1243319|NCT00556972|Secondary|What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?||After application of product||||Pouche and Bag|Participants||Number
1243320|NCT00556972|Secondary|Assessment of Skin 0-2 Inches From the Edge of the Anus|Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6.|Subjects were evaluated before and after test|ITT|||Scores on a scale||Standard Deviation|Mean
1243321|NCT00556972|Secondary|Is the Barrier Size and Shape Satisfactory|Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory|Subjects were followed for the duration of the study, an average of 23 hours|ITT|||Percentage of subjects|||Number
1243322|NCT00556972|Primary|The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)||5 days|ITT|||Hours||Standard Deviation|Mean
1243323|NCT00556946|Primary|Blanching of Port Wine Stain Birthmark||12 weeks||||participants|||Number
1243324|NCT00556933|Secondary|Ratio of CD4/CD8 Lymphoid Cells||One year||||Ratio of cell counts||Standard Deviation|Mean
1243325|NCT00556933|Secondary|New-onset Diabetes and Hyperglycemia After Transplantation (NODAT)||Six months||||participants|||Number
1243326|NCT00556933|Secondary|New-onset Polyomavirus (BK Virus) Disease Per Kidney Biopsy||Two years||||participants|||Number
1243327|NCT00556933|Secondary|Lymphoid Cell Sub-type CD3 Absolute Numbers||One year||||CD3 Cell Numbers/mm^3||Standard Deviation|Mean
1243328|NCT00556933|Secondary|Patient Survival||Two years||||participants|||Number
1243329|NCT00556933|Secondary|Graft Survival|Graft failure = permanent return of patient to dialysis.|Two years||||participants|||Number
1243330|NCT00556933|Secondary|Acute Tubular Necrosis (ATN) Rate, Defined as the Requirement for Dialysis Within 7 Days Post-transplantation.||Seven days||||participants|||Number
1243331|NCT00556933|Secondary|Acute Rejection Per Kidney Biopsy (Banff Grading Criteria)||Two years||||participants|||Number
1243332|NCT00556933|Secondary|Requirement for Additional Immunosuppression (Such as Corticosteroids, Antimetabolites or Other Immunosuppressive Agents)||Two years||||participants|||Number
1243333|NCT00556933|Secondary|Safety Profile|Number of events: cytomegalovirus (CMV) disease, opportunistic infections (bacteremia, abscess, pneumonia, fungal), Post-transplantation Lymphoproliferative Disorder (PTLD), wound healing problems within 30 days, and lymphoceles.|Two years||||Events|Participants||Number
1243334|NCT00556933|Primary|Average of Renal Function|Calculated Glomerular Filtration Rate (GFR) by using the abbreviated MDRD (aMDRD) formula and patient serum creatinine and demographic data; averaged values from months four through 24.|Two years||||ml/min/1.73m2||Standard Deviation|Mean
1243335|NCT00556933|Primary|Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).|Protocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickening (cv). Severity scores within each category could be 0 (<5%; none or minimal), 1 (>5% - <25%; mild), 2 (>25% - <50%, moderate), or 3 (>50%, severe). The proportions of patients in each severity grade (0, 1, 2, and 3) for both the individual categories and a composite were compared using Fisher’s exact test.|Two years||||percentage of participants|||Number
1243336|NCT00556894|Secondary|ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters|ACR20/50/70 responses over time (intent-to-treat [ITT], last observation carried forward [LOCF]), mean changes in individual components of the ACR response criteria, DAS28, European League Against Rheumatism (EULAR) responses|12 weeks|||||||
1243337|NCT00556894|Primary|ACR20 at Week 12|Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria|12 weeks||||participants|||Number
1243338|NCT00556712|Secondary|Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)|"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; n=number of participants assessed for the given parameter at the specified timepoint.|||score on a scale||Standard Deviation|Mean
1243339|NCT00556712|Secondary|Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)|"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; n=number of participants assessed for the given parameter at the specified timepoint.|||score on a scale||Standard Deviation|Mean
1243340|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)|"Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS|||percentage of participants||95% Confidence Interval|Number
1243341|NCT00556712|Secondary|Time to Deterioration in QoL (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS|||weeks||95% Confidence Interval|Median
1243342|NCT00556712|Secondary|Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)|"Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 62 and 51 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively,|||percentage of participants|||Number
1243343|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)|"TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS|||percentage of participants||95% Confidence Interval|Number
1243344|NCT00556712|Secondary|Time to Deterioration in TOI (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS|||weeks||95% Confidence Interval|Median
1243358|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1246340|NCT00536107|Primary|Number of Patients With Serious Adverse Events (SAEs)||From time consent was given to 28 days after last dose||||participants|||Number
1243345|NCT00556712|Secondary|Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)|"The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 59 and 49 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.|||percentage of participants|||Number
1243346|NCT00556712|Primary|Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; only participants with EGFR IHC positive tumors were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243347|NCT00556712|Primary|PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS;only participants with EGFR IHC positive tumors were included in the analysis.|||weeks||95% Confidence Interval|Median
1243348|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)|"LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS|||percentage of participants||95% Confidence Interval|Number
1243349|NCT00556712|Secondary|Time to Symptom Progression (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS|||weeks||95% Confidence Interval|Median
1243350|NCT00556712|Secondary|Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)|"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 56 and 48 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.|||percentage of participants|||Number
1243351|NCT00556712|Secondary|Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)|Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243413|NCT00556478|Secondary|Partner Premature Ejaculation Profile (PEP) at Month 3|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the partner PEP at month 3. Proportion of partners with at least a 1 point category improvement in partner PEP domain scores from baseline to month 3.|3 months|ITT|||percentage of partners|||Number
1243352|NCT00556712|Secondary|Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243353|NCT00556712|Secondary|Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)|Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243354|NCT00556712|Secondary|Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis; and 7 and 17 participants were not assessed from the Placebo and Erlotinib, 150 mg/day groups, respectively.|||percentage of participants||95% Confidence Interval|Number
1243355|NCT00556712|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)|BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243356|NCT00556712|Secondary|Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)|TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; participants with PD prior to randomization were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1243357|NCT00556712|Secondary|Time to Progression (Data Cutoff 17 May 2008)|The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.|||weeks||95% Confidence Interval|Median
1243430|NCT00556426|Primary|Percentage of Participants With Adverse Events Through 30 Days Post Retrieval|Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure|30 days post retrieval|61 of 100 patients underwent filter retrieval during the study.|||percentage of participants||95% Confidence Interval|Number
1243359|NCT00556712|Secondary|OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||months||95% Confidence Interval|Median
1243360|NCT00556712|Secondary|Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||percentage of participants|||Number
1243361|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243362|NCT00556712|Secondary|PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||weeks||95% Confidence Interval|Median
1243363|NCT00556712|Secondary|Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||percentage of participants|||Number
1243364|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS|||percentage of participants||95% Confidence Interval|Number
1243365|NCT00556712|Secondary|OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.|||months||95% Confidence Interval|Median
1243366|NCT00556712|Secondary|Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.|||percentage of participants|||Number
1243367|NCT00556712|Secondary|Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS|||percentage of participants||95% Confidence Interval|Number
1243368|NCT00556712|Secondary|Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS|||months||95% Confidence Interval|Median
1243369|NCT00556712|Secondary|Percentage of All Participants Who Died (Data Cutoff 12 January 2012)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).|FAS|||percentage of participants|||Number
1243431|NCT00556426|Primary|Clinical Success (Retrieval)|technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.|Time of Retrieval or through 6 months of implantation|61/100 patients experienced filter retrieval during the study|||participants|||Number
1243370|NCT00556712|Primary|Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.|||percentage of participants|||Number
1243371|NCT00556712|Primary|Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; participants with PD prior to randomization were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1243372|NCT00556712|Primary|PFS in All Participants (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.|||weeks||95% Confidence Interval|Median
1243373|NCT00556712|Primary|Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)|Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.|||percentage of participants|||Number
1243374|NCT00556673|Secondary|Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||hours||Full Range|Median
1243375|NCT00556673|Secondary|Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||hours||Full Range|Median
1243376|NCT00556673|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg/mL||Standard Deviation|Mean
1243377|NCT00556673|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg/mL||Standard Deviation|Mean
1243378|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg*h/mL||Standard Deviation|Mean
1243379|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg*h/mL||Standard Deviation|Mean
1243380|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg*h/mL||Standard Deviation|Mean
1243381|NCT00556673|Secondary|Change From Period Baseline in Peak FEV1/FVC Ratio|The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population|||ratio||90% Confidence Interval|Least Squares Mean
1243392|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Bodily Pain Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
1243382|NCT00556673|Secondary|Change From Period Baseline in Trough FEV1/FVC Ratio|The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population|||ratio||90% Confidence Interval|Least Squares Mean
1243383|NCT00556673|Secondary|Change From Period Baseline in Peak Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population|||liters||90% Confidence Interval|Least Squares Mean
1243384|NCT00556673|Secondary|Change From Period Baseline in Trough Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population|||liters||90% Confidence Interval|Least Squares Mean
1243385|NCT00556673|Secondary|Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|"Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population|||Percent of predicted||90% Confidence Interval|Least Squares Mean
1243386|NCT00556673|Secondary|Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|"Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population|||Percent of predicted||90% Confidence Interval|Least Squares Mean
1243387|NCT00556673|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population|||liters||90% Confidence Interval|Least Squares Mean
1243388|NCT00556673|Primary|Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population included all patients randomized that received at least one dose of study drug and completed the first two treatment periods with evaluable data for the primary efficacy variable, and with no major protocol deviations. 7 patients who were inadvertently unblinded by the investigator were excluded from the PD analysis.|||liters||90% Confidence Interval|Least Squares Mean
1243389|NCT00556543|Primary|The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)|The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||PRI||Standard Deviation|Mean
1243390|NCT00556543|Primary|The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)|The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||PPI||Standard Deviation|Mean
1243391|NCT00556543|Primary|The Rand 36-Item Health Survey Results - General Health Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
1243409|NCT00556491|Secondary|Infections Post Operative||30 days post operative||||Participants|||Count of Participants
1243393|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Social Functioning Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
1243394|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Emotional Well-being Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
1243395|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Vitality Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
1243396|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
1243397|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
1243398|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Physical Functioning Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
1243399|NCT00556543|Primary|Adverse Post-op Events Related to the Repair and Plating System|Clinical evaluations or chest radiographs at a minimum of 1 and 6 months|180 days|Per Protocol|||Participants|||Number
1243400|NCT00556504|Secondary|Immune Cell Normalization|Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.|24 weeks after the termination of combinational drug treatment (up to 72 weeks)||||participants|||Number
1243401|NCT00556504|Secondary|Immune Cell Normalization|"Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment~(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)"|at the end of combination drug treatment (up to 48 weeks)||||participants|||Number
1243402|NCT00556504|Secondary|Combined ALT and Virologic Response|Combined ALT and virologic response at the end of combination drug treatment.|at the end of combination drug treatment (up to 48 weeks)||||participants|||Number
1243403|NCT00556504|Secondary|Sustained ALT Response|a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.|24 weeks after the termination of combinational drug treatment (up to 72 weeks)||||participants|||Number
1243404|NCT00556504|Secondary|ALT Response|"An ALT response is defined as normalization of ALT at the end of combination drug treatment.~(ALT normalization is defined as ALT level decreases into within the normal range)"|at the end of combination drug treatment (up to 48 weeks)||||participants|||Number
1243405|NCT00556504|Secondary|Virologic Response|"undetectable HCV RNA at the end of combination drug treatment~Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)."|at the end of combination drug treatment (up to 48 weeks)||||participants|||Number
1243406|NCT00556504|Primary|Sustained Virologic Response (SVR)|"SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..~A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.~If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.~If the patient’s HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.~Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)"|24 weeks after the termination of combinational drug treatment (up to 72 weeks)||||Number of participants with SVR|||Number
1243407|NCT00556491|Secondary|Re-operation||30 days post-operative||||Participants|||Count of Participants
1243408|NCT00556491|Secondary|Stroke Post Operative||30 days post op||||Participants|||Count of Participants
1243414|NCT00556478|Secondary|Subject Premature Ejaculation Profile (PEP) at Month 3|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 3. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 3.|3 months|ITT|||percentage of participants|||Number
1243415|NCT00556478|Secondary|Subject Premature Ejaculation Profile (PEP) at Month 2|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 2. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 2.|2 months|ITT|||percentage of participants|||Number
1243416|NCT00556478|Secondary|Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2|"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 2~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|2 months|ITT|||Score||Standard Deviation|Mean
1243417|NCT00556478|Secondary|Subject PEP at Month 1|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 1. Percentage of subjects with at least a 1 point category improvement in subject PEP domain scores at month 1.|1 month|ITT|||percentage of participants|||Number
1243418|NCT00556478|Secondary|Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1|"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 1.~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|1 month|ITT|||Score||Standard Deviation|Mean
1243419|NCT00556478|Secondary|Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3|Summary of mean IELT at Baseline and at month 3 during double-blind treatment|3 months|ITT|||Seconds||Standard Deviation|Geometric Mean
1243420|NCT00556478|Secondary|Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment|Percentage of subjects with mean IELT > 1 minute and >2 minutes during the 3 months of double-blind treatment as measured by the proportion of subjects|3 months|ITT|||percentage of subjects|||Number
1243421|NCT00556478|Primary|Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3|"To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by:~• changes in all 3 IPE domains from baseline to month 3~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|Baseline to 3 Months|ITT|||Score||Full Range|Mean
1243422|NCT00556478|Primary|Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment|"To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by:~• change in mean IELT from baseline to during the 3 month double-blind treatment~Results provide are ratio (over the 3 months/baseline)."|Baseline to 3 Months|ITT|||ratio||Full Range|Geometric Mean
1243423|NCT00556452|Secondary|Five Year Overall Survival for All Cases|The number of patients alive at 5 years|five years||||Participants|||Count of Participants
1243424|NCT00556452|Secondary|Two-year Overall Survival for All Cases.|Percent Overall Survival (OS) at two years for all patients.|2 years||||percent overall survival||95% Confidence Interval|Number
1243425|NCT00556452|Primary|One-year Overall Survival Rate for AML|Percent Overall Survival (OS) for at one year for subjects with Acute Myeloid Leukemia (AML).|1 year|Patients with Acute Myeloid Leukemia (AML)|||percent overall survival||95% Confidence Interval|Number
1243426|NCT00556452|Primary|Regimen Related Toxicities|The incidence of non-hematological toxicities (Common Terminology Criteria for Adverse Events (CTCAE) 3.0) from initiation of conditioning to Day + 30 or toxicities after day +30, possibly, probably or definitely related to conditioning for all patients treated with Clofarabine (independent of dose level).|two years||||toxicities|||Number
1243427|NCT00556439|Primary|Primary Outcome - Relapse-free Survival (RFS)|"Relapse: presence of active disease occurring after a period of remission~Remission: absence of active disease~Active disease defined by clinical features or imaging or both:~Clinical features:~1 or more of the following attributed to GCA/TAK:~Sustained fever of >38 C for > 1 week~Vascular pain/tenderness > 1 day, non-fleeting~Headache a) present > 1 day b) non-fleeting c) not relieved with analgesics d) not typical for pre-existing headaches~Ischemic retinopathy, optic neuropathy, or visual loss~Tongue/jaw pain and/or claudication~TIA or stroke~Extremity claudication~Musculoskeletal symptoms + ESR of > 40 mm/hr or CRP above the normal limit~Malaise/fatigue + ESR of > 40 mm/hr or CRP above the normal limit~Other symptoms/signs due to GCA/TAK requiring reinstitution/increase in GC~Imaging features~• Development of new vascular stenosis or aneurysm in new vascular territories as seen by MRI/MRA or arteriogram"|Weeks 0 to 64|The primary study endpoint was relapse-free survival (RFS). Kaplan-Meier curves of RFS were constructed for each stratum (giant cell arteritis and Takayasu arteritis), and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.|||Participants|||Count of Participants
1243428|NCT00556426|Secondary|Incidence of Filter Fracture|occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)|at 6 months or at retrieval of the filter|adequate imaging was available to assess filter integrity in 83 of the 100 participants.|||number of fractured filters|||Number
1243429|NCT00556426|Secondary|Filter Migration > 2cm|Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.|30 days post retrieval or 6 months following filter placement|Migration measurement made for 58 retrieved subjects, 22 non-retrieved subjects reaching the 6 month visit, and 2 non-retrieved subjects with attempted retrievals and imaging.|||Percent Subjects with Filter Migration|||Number
1243432|NCT00556426|Primary|Technical Success (Retrieval)|Technical success for retrieval of the filter such that the entire filter is removed.|1 month post filter retrieval or through 6 months following implantation|61 of 100 patients enrolled underwent filter retrieval during the study.|||participants|||Number
1243433|NCT00556400|Secondary|Total Number of Bleeding Days During the First 7 Days.||1 week|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.||||||
1243434|NCT00556400|Secondary|Proportion Who Stop Uterine Bleeding by Day 14.||2 weeks|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.||||||
1243435|NCT00556400|Primary|Stop Vaginal Bleeding or Spotting.||1 week|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.||||||
1243436|NCT00556374|Secondary|Overall Survival|Overall survival (OS) determined by the time from randomization to death from any cause. OS will be analyzed after long-term follow-up is complete.|Participants will be followed for overall survival once every 12 months for 66 months after primary completion date.||2020-10-31|10/2020||||
1243437|NCT00556374|Secondary|Bone Metastases-free Survival|Bone metastasis-free survival (BMFS) determined by the time from randomization to the first observation of bone metastasis or death from any cause. BMFS will be analyzed after long-term follow-up is complete.|Participants will be followed for bone metastasis-free survival once every 12 months for 66 months after primary completion date.||2020-10-31|10/2020||||
1243438|NCT00556374|Secondary|Disease-free Survival|Disease-free survival (DFS) determined by the time from randomization to the first observation of disease recurrence or death from any cause. DFS will be analyzed after long-term follow-up is complete.|Participants will be followed for disease-free survival (DFS) once every 12 months for 66 months after primary completion date.||2020-10-31|10/2020||||
1243439|NCT00556374|Secondary|Number of Participants With New or Worsening Vertebral Fractures|Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture is defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures is defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale.|36 months|Vertebral Fracture Analysis Set with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36.|||participants|||Number
1243440|NCT00556374|Secondary|Number of Participants With New Vertebral Fractures|"Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height.~A new vertebral fracture is defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays."|36 months|Vertebral Fracture Analysis Set with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36.|||participants|||Number
1243441|NCT00556374|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - femoral neck at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for femoral neck)|||percent change||95% Confidence Interval|Least Squares Mean
1243442|NCT00556374|Secondary|Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - total hip at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for total hip)|||percent change||95% Confidence Interval|Least Squares Mean
1243443|NCT00556374|Secondary|Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - total lumbar spine at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for total lumbar spine)|||percent change||95% Confidence Interval|Least Squares Mean
1243444|NCT00556374|Primary|Time to First Clinical Fracture|The time to first on-study clinical fracture defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.|From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on study was 87 months.|Full analysis set (all randomized participants)|||days||95% Confidence Interval|Median
1243445|NCT00556322|Secondary|Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L|TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Kaplan-Meier estimates were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243475|NCT00556075|Primary|Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score||4 months|Zero participants were analyzed because no data were collected due to early termination||||||
1243476|NCT00556075|Primary|Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score||4 months|Zero participants were analyzed because no data were collected due to early termination||||||
1243446|NCT00556322|Secondary|Time to Deterioration in the TOI|TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||weeks||95% Confidence Interval|Median
1243447|NCT00556322|Secondary|Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)|TOI is defined as the sum of the scores of the Physical Well- Being (PWB), Functional Well-Being (FWB), and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants|||Number
1243448|NCT00556322|Secondary|Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L|Participants’ responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243449|NCT00556322|Secondary|Time to Symptomatic Progression Using FACT-L|Participants’ responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||weeks||95% Confidence Interval|Median
1243450|NCT00556322|Secondary|Percentage of Participants With Symptomatic Progression Using FACT-L|Participants’ responses on the FACT-L were scored according to the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants|||Number
1243451|NCT00556322|Secondary|Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Kaplan Meier estimates were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1243452|NCT00556322|Secondary|Time to Deterioration in Quality of Life Using FACT-L|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||weeks||95% Confidence Interval|Median
1243453|NCT00556322|Secondary|Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants|||Number
1243454|NCT00556322|Secondary|Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST|Best overall response was defined as the best response according to RECIST recorded from the date of randomization until disease progression or recurrence. CR: disappearance of all target lesions; PR: reduction by at least 30% of the sum of the longest diameters of each target lesion, taking the initial sum of the longest diameters as a reference; Stable disease (SD): insufficient tumor reduction to define partial response and/or tumor increase less than that necessary to define tumor progression, taking as a reference the smallest sum of the longest diameter since the start of treatment; Progressive Disease (PD): increase by at least 20% in the sum of LD of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method. Participants with a missing response were considered non-responders.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1243455|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. Tumor response was evaluated according to RECIST criteria (version 1.0). PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Event free estimates were determined using Kaplan-Meier estimates.|6 Months|FAS population; n=number of EGFR positive or negative participants who remained at risk|||percentage of participants||95% Confidence Interval|Number
1243456|NCT00556322|Secondary|PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only Participants with confirmed status of EGFR were included in the analysis; number of participants who were EGFR positive or negative|||weeks||95% Confidence Interval|Median
1243457|NCT00556322|Secondary|Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC.Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as At least a 20 % increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative|||percentage of participants|||Number
1243458|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months|Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Event free estimates were determined using Kaplan-Meier estimates.|6 Months|FAS population|||percentage of participants||95% Confidence Interval|Number
1243459|NCT00556322|Secondary|Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)|Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population|||weeks||95% Confidence Interval|Median
1243477|NCT00556049|Primary|To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.||Until disease progression||||percentage of participants|||Number
1243478|NCT00555997|Secondary|Change in 6-VAS-D Scores During Each Phase.||6 weeks|Forms not analyzable due to insufficient standardization across sites.||||||
1243460|NCT00556322|Secondary|Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)|Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.0). Progressive Disease was defined as at least a 20 percent (%) increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The primary analysis of PFS used objective progression (RECIST) plus clinical progression (based on relevant clinical findings - if any). A further assessment of PFS was made on objective (radiological) progression. If clinical progression was diagnosed first, the participant was censored at the date of the last tumor assessment, where non-progression was documented.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population|||percentage of participants|||Number
1243461|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|1 Year|FAS population; n=number of EGFR positive or negative participants remaining at risk|||percentage of participants||95% Confidence Interval|Number
1243462|NCT00556322|Secondary|Duration of OS in EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative|||months||95% Confidence Interval|Median
1243463|NCT00556322|Secondary|Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative|||percentage of participants|||Number
1243464|NCT00556322|Primary|Probable Percentage of Participants Remaining Alive at 1 Year|OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.|1 Year|FAS population|||percentage of participants||95% Confidence Interval|Number
1243465|NCT00556322|Primary|Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)|OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population|||months||95% Confidence Interval|Median
1243466|NCT00556322|Primary|Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)|Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months|FAS population|||percentage of participants|||Number
1243467|NCT00556166|Secondary|Number of Episodes of Abdominal Pain, Bloating, and Early Satiety|Data was not analyzed because PI left institution and terminated the study early.|1 year|||||||
1243468|NCT00556166|Primary|Number of Episodes of Nausea and Vomiting|Data was not analyzed because PI left institution and terminated the study early.|1 year|||||||
1243469|NCT00556140|Secondary|Depression and Psychosis Remission Rate|This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.|Baseline and 7 weeks|"For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them."|||percent of participants|||Number
1243470|NCT00556140|Primary|Depression and Psychosis Response Rate|This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.|Baseline and 7 weeks|"For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them."|||percent of participants|||Number
1243471|NCT00556075|Secondary|The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits||days|Zero participants were analyzed because no data were collected due to early termination||||||
1243472|NCT00556075|Secondary|Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries||days|Zero participants were analyzed because no data were collected due to early termination||||||
1243473|NCT00556075|Secondary|Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries||days|Zero participants were analyzed because no data were collected due to early termination||||||
1243474|NCT00556075|Secondary|Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits||monthly|Zero participants were analyzed because no data were collected due to early termination||||||
1243481|NCT00555906|Secondary|Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2|m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 “No pain” to 10 “Pain as bad as you can imagine”. The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||95% Confidence Interval|Mean
1243482|NCT00555906|Secondary|Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2|The QLQ-MY20 consisted of 20 items addressing 4 domains of health-related quality of life (HRQoL) important to participants with multiple myeloma: future perspective (2 items), pain/disease symptoms (6 items), social support /body image (2 items), and treatment side-effects (10 items). All items used 4 point scale (1 'Not at all' to 4 'Very much'). Scores for HRQoL domains were calculated as an average of the individual items, transformed to 0 to 100 range. Higher scores on symptom scales (disease symptoms and side effects of treatment) indicated a higher level of symptoms/problems. Higher scores on functional scales (future perspective and body image) indicated a higher level of QoL/functioning.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at spefied time points for each arm, respectively.|||units on a scale||95% Confidence Interval|Mean
1243483|NCT00555906|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores for functional scales, global health status and symptom scales were calculated as an average of individual items, transformed to 0-100 scale; higher score=better level of functioning, health status or greater degree of symptoms. Score of the single items were transformed to 0-100 scale; higher score=greater degree of symptom/difficulty.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|Patient Reported Outcomes (PRO) analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||95% Confidence Interval|Mean
1243484|NCT00555906|Secondary|Number of Participants With Laboratory Abnormalities: Phase 2|Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology [C reactive protein]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|SAS included all enrolled participants who received at least 1 dose of study treatment.|||participants|||Number
1243485|NCT00555906|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication until 28 days after the last dose of study medication that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study medication, which occurred during the trial. Treatment-related were adverse events (serious as well as non-serious adverse events) considered related to study medication by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|SAS included all enrolled participants who received at least 1 dose of study treatment.|||participants|||Number
1243486|NCT00555906|Secondary|Number of Participants With Adverse Events (AEs) by Severity: Phase 2|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded according to the common terminology criteria for adverse events (CTCAE) criteria as 1=mild AE, 2=moderate AE, 3=severe AE, 4=life-threatening or disabling AE, 5=Death related to AE. The most severe grade was used in case of multiple occurrences of the same event.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|Safety analysis set (SAS) included all enrolled participants who received at least 1 dose of study treatment.|||participants|||Number
1246341|NCT00536107|Primary|Number of Patients With Adverse Event (AE)||From time consent was given to 28 days after last dose of study drug.|Evaluable for Safety population: All patients who recived at least one dose of study drug|||Participants|||Number
1243487|NCT00555906|Secondary|Overall Survival (OS): Phase 2|OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date [if death date unavailable] minus the date of first dose of study medication plus 1) divided by 30.44.|Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.|||months||95% Confidence Interval|Median
1243488|NCT00555906|Secondary|Duration of Objective Response (DR): Phase 2|DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24hr urine M-protein. PR:>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr. PD: >=25% increase from lowest response level in serum M-component, urine M-component, >=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|PRAS was defined as the first consecutive (by first treatment day) participants in RAS (RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. DR was calculated for the subgroup of PRAS participants with objective response.|||months||95% Confidence Interval|Median
1243489|NCT00555906|Secondary|Progression-free Survival (PFS): Phase 2|"PFS was the time from start of study treatment to date progressive disease was documented or death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder."|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.|||months||95% Confidence Interval|Median
1243490|NCT00555906|Secondary|Time to Tumor Progression (TTP): Phase 2|TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per IMWGURC). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.|||months||95% Confidence Interval|Median
1243491|NCT00555906|Secondary|Best Overall Response: Phase 1|Best overall response: best confirmed response on study after first study dose as per IMWGURC. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24 hr urine M-protein. PR: >=50% reduction of serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200mg/24 hr. Progressive disease (PD): >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. Stable disease (SD): criteria for CR, VGPR, PR or PD not met.|Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B)|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.|||participants|||Number
1243492|NCT00555906|Secondary|Percent Change From Screening in Phosphorylated Retinoblastoma (Rb), Tumor Biomarkers and Soluble Biomarkers Levels: Phase 1||Screening, C1D1(baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|Results are not reported because data was present as individual participant listings but not summarized for analysis, as per change in planned analysis.||||||
1243493|NCT00555906|Primary|Percentage of Participants With Objective Response (OR): Phase 2|OR: confirmed stringent complete response(sCR),complete response(CR),very good partial response(VGPR) or partial response(PR) as per International Myeloma Working Group Uniform Response Criteria (IMWGURC). sCR: normal serum free light chain (FLC) ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5 percent (%) plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >= 90% reduction in serum M-protein, <100 mg/24 hour (hr) urine M-protein. PR: >=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr, >=50% decrease in difference between involved and uninvolved FLC levels if serum, urine M-protein were unmeasurable, >= 50% reduction in plasma cells, provided baseline bone marrow plasma cell was >=30% if serum, urine M-protein were unmeasurable and serum free light assay was unmeasureable.|Cycle 1 Day 1 (baseline) up to end of study (up to cycle 22 for schedule B)|Primary response analysis set (PRAS) included first consecutive (by first treatment day) participants in response analysis set (RAS=included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable.|||percentage of participants||95% Confidence Interval|Number
1243494|NCT00555906|Primary|Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1|RP2D was determined based on the MTD, safety and tolerability profile of the study treatment.|Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B|DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.|||milligram (mg)|||Number
1243495|NCT00555906|Primary|Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1|MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever >=38.5degrees Celsius (C); Grade >=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc >500 millisecond [msec]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count <25,000/mcL and/or ANC <500/mcL, or due to prolonged nonhematologic toxicities of Grade >=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity.|Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B|DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.|||milligram (mg)|||Number
1243496|NCT00555893|Secondary|Mean Influenza Well-being Score|Mean influenza wellbeing score is calculated by first summing the daily scores for overall health (0-9 points), ability to perform usual activities (0-9 points), and sleep quality (0-9 points) from initial enrollment (randomization) up to (and including) the first day of symptom resolution. This is divided by the number of reporting days to yield the mean daily influenza wellbeing score for each person. Minimum score is 0 and maximum is 27. Higher scores indicate better outcome.|Randomization to resolution|The analysis is restricted to subjects randomized 48 to 119 hours after illness onset.|||score on a scale||Standard Deviation|Mean
1243497|NCT00555893|Secondary|Secondary Complications (Otitis Media, Sinusitis, Pneumonia, Hospital Admission)||30 days from symptom onset|These data were not collected because study was terminated early and did not achieve target enrollment.||||||
1243498|NCT00555893|Secondary|Viral Shedding on Day 3-4 of Treatment|Proportion of participants with positive PCR on day 3-4 of treatment|3-4 days after treatment initiation|134 subjects were randomized and initiated treatment 48-119 hours after illness onset (late treatment group). Of these 95 received oseltamivir and 39 received placebo.|||Participants|||Count of Participants
1243499|NCT00555893|Secondary|Mean Illness Severity Score|Mean severity score will be calculated by first summing the symptom severity scores for all reporting periods from initial enrollment (randomization) up to (and including) the first period of symptom resolution, as defined above. The summed total will be divided by the number of reporting periods to yield the mean severity score for each participant. For each reporting period, the possible symptom scores will range from 0 (all symptoms absent) to 24 (all symptoms severe). For children less than 2 years old, the possible scores will range from 0 to 15.|Calculated from initial enrollment (randomization) up to first period of symptom resolution (minimum of 7 days, maximum of 14 days)|All participants over 24 months of age (n=5 were excluded because <24 months)|||mean severity score||Inter-Quartile Range|Median
1243500|NCT00555893|Primary|Duration of Influenza Illness|Resolution is defined as occurring at the start of the first 24-hour period in which the total symptom score was less than or equal to 2 with no symptom rated higher than mild. Time to resolution was calculated from the time of randomization to symptom resolution in 12 hour increments.|Interval (in 12 hour blocks) from time of randomization until resolution (minimum 7 days, maximum 14 days)||||days||95% Confidence Interval|Median
1243501|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Urinalysis at Discharge|For urinalysis, samples were taken at screening, study admission (if greater than 14 days since screening) and discharge/early termination): glucose, blood, protein, pH, specific gravity, leukocyte esterase, and microscopic examination. A shift in reference to normal was higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.|||participants|||Number
1243502|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing-Re-analysis With The Koch Procedure|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. The Koch procedure is a 3-step process to analyze results while utilizing the available information on magnitude of differences.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Deviation|Mean
1243503|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Clinical Chemistry at Discharge|For biochemistry, blood samples (10.0mL) were taken at screening, admission (if greater than 14 days since screening) and discharge/early termination. The following parameters were assessed: sodium, potassium, calcium, blood urea nitrogen (BUN)/Urea, creatinine, albumin, total protein and albumin/globulin (A/G) ratio, globulin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), total bilirubin, glucose, chloride, and creatine kinase. A shift in reference to normal was either lower or higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.|||participants|||Number
1243563|NCT00555620|Secondary|Cmin of 5-FU||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243504|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Hematology Analytes at Discharge|For hematology, blood samples (5.0mL) were taken at screening, study admission (if greater than 14 days since screening) and discharge/early termination. The following parameters were assessed: hemoglobin, hematocrit, red blood cells (RBC), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell count – total and differential (WBC), and platelet count. A shift in reference to normal was either lower or higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.|||participants|||Number
1243505|NCT00555880|Secondary|Heart Rate at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Heart rate was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||beats per minute||Standard Deviation|Mean
1243506|NCT00555880|Secondary|Diastolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Blood pressure was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||mmHg||Standard Deviation|Mean
1243507|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing Analysis #2|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near- syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. In this outcome measure, the data analyzed are the same as for Outcome Measure 1 but the summary data are presented as least squares mean (standard error).|1 hour post-dose|The FAS, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Error|Least Squares Mean
1243508|NCT00555880|Secondary|Systolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Blood pressure was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||mmHg||Standard Deviation|Mean
1243509|NCT00555880|Secondary|Final Blood Pressure During Tilt Table Testing|Blood pressure was recorded just before tilt table testing and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||mmHg||Standard Deviation|Mean
1243529|NCT00555750|Secondary|Change in Insulin Sensitivity (SI)|"Insulin sensitivity index (SI) was defined in quantitative terms as the effect of insulin to catalyse the disappearance of glucose from plasma. [R. Bergman, Horm Res 2005;64(suppl 3):8-15].~SI calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)"|baseline and 2 months post-treatment||||mU/l)^-1*min^-1||Standard Deviation|Mean
1243510|NCT00555880|Secondary|Number of Participants With Improvement of Patient CGI-I Scores After Tilt Table Test|"The CGI-I instrument assesses the overall impression of the subject's orthostatic hypotension during the tilt table test by using a 7-point scale, with 1 being Very much improved; 2, Much improved; 3, Slightly improved; 4, No change; 5, Slightly worse; 6, Much worse; and 7, Very much worse. The patient completed the CGI-I after each of the tilt table tests. A patient was assessed as Improved if the score was 1, 2, or 3. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||participants|||Number
1243511|NCT00555880|Secondary|Number of Participants With Improvement of Clinician Clinician's Global Impression- Improvement (CGI-I) Scores After Tilt Table Test|"The CGI-I instrument assesses the overall impression of the subject’s orthostatic hypotension during the tilt table test by using a 7-point scale, with 1 being Very much improved; 2, Much improved; 3, Slightly improved; 4, No change; 5, Slightly worse; 6, Much worse; and 7, Very much worse. The clinician completed the CGI-I after each of the tilt table tests. A patient was assessed as Improved if the score was 1, 2, or 3. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||participants|||Number
1243512|NCT00555880|Secondary|Scores for 6 Items of The OHSA|"The OHSA measures the severity of six symptoms/symptom complexes associated with OH: dizziness, lightheadedness, and feeling faint; problems with vision; weakness; fatigue; trouble concentrating; and head/neck discomfort. Subjects rated symptoms experienced during the tilt table test on an eleven-point scale from none to worst possible. Scores for each subscale range from 0 (no symptoms) to 10 (worst possible symptoms). The OHSA was completed after the tilt table test was over, but was answered with reference to symptoms experienced during testing. The tilt table test is a 10-minute assessment performed using a tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured with straps to prevent injury. After an equilibration period with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, and feeling faint."|Approximately 1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||scores on a scale||Standard Deviation|Mean
1243513|NCT00555880|Secondary|Total Score of the Orthostatic Hypotension Symptom Assessment (OHSA)|The OHSA measures the severity of six symptoms/symptom complexes associated with orthostatic hypotension. Subjects rated symptoms experienced during the tilt table test on an eleven-point scale from “none” to “worst possible”. The OHSA total score is the sum of six subscales, ranging from 0 (no symptoms) to 60 (worst possible symptoms). The OHSA was completed after the tilt table test was over, but was answered with reference to symptoms experienced during testing. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|Approximately 1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||scores on a scale||Standard Error|Least Squares Mean
1243514|NCT00555880|Secondary|Duration of The Effect of Treatment at 3 Hours Post-dose|Duration of effect was defined as the difference in time to onset of near-syncopal symptoms between the first and second tilt table test, conducted at 1 hour and 3 hours post-dose, respectively, at Treatment Visit 2 (time to onset at 3 hours minus time at 1 hour). The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Deviation|Mean
1243515|NCT00555880|Secondary|Time to Near-syncopal Symptoms at Treatment Visit 1|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Error|Least Squares Mean
1243516|NCT00555880|Secondary|Time to Onset of Near-syncopal Symptoms in The Per-protocol Population Analysis #2|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near- syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. In this outcome measure, the data analyzed are the same as for Outcome Measure 4 but the summary data are presented as least squares mean (standard error).|1 hour post-dose|The Per-protocol set, defined as participants in the Full Analysis Set who completed the study and were protocol compliant.|||seconds||Standard Error|Least Squares Mean
1243517|NCT00555880|Secondary|Time to Onset of Near-syncopal Symptoms in The Per-protocol Population|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Per-protocol set, defined as participants in the Full Analysis Set who completed the study and were protocol compliant.|||seconds||Standard Deviation|Mean
1243518|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set (FAS), defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Deviation|Mean
1243519|NCT00555750|Secondary|Change in Total Sleep Time Measured by PSG|Change (baseline minus post-treatment) in total sleep time measured by polysomnography after two months treatment with 3mg eszopiclone or placebo|baseline and 2 months post-treatment||||minutes||Standard Deviation|Mean
1243520|NCT00555750|Secondary|Change in Total Sleep Time as Reported in Sleep Diaries|Total sleep time reported on sleep diaries prior to treatment with 3mg eszopiclone or placebo. Change defined as baseline minus post-treatment).|baseline and 2 months post-treatment||||hours||Standard Deviation|Mean
1243521|NCT00555750|Secondary|Change in Mean Lapses of Attention|At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery every three hours during wake periods. The battery included the Psychomotor Vigilance Task (PVT). The PVT involved a 10-minute visual reaction time (RT) performance test in which the subject was instructed to maintain the fastest possible RT to a simple visual stimulus. Lapses of attention refer to the number of times the subject failed to respond to the signal within 500ms. Mean lapses per test across 6 tests given a 4 hour intervals during normal waking hours (and not during the IVGTT) during the 30-hr were compared for the post-treatment visit as the absolute deviation from the baseline mean lapses/test.|baseline and 2 months post-treatment||||lapses of attention||Standard Error|Mean
1243522|NCT00555750|Secondary|Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)|"At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery including the Karolinska Sleepiness Scale (KSS) every three hours during wake periods. KSS is a single-item scale of sleepiness on a scale from 1 (very alert) to 9 (very sleepy, fighting sleep, an effort to keep awake). Subjective sleepiness was defined as mean deviation from baseline KSS."|baseline and 2 months post-treatment||||units on a scale||Standard Error|Mean
1243523|NCT00555750|Secondary|Post-treatment Ghrelin Levels|Ghrelin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|2 months post-treatment||||ng/mL||Standard Deviation|Mean
1243524|NCT00555750|Secondary|Pre-treatment Ghrelin Levels|Ghrelin levels prior to two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|baseline||||ng/mL||Standard Deviation|Mean
1243525|NCT00555750|Secondary|Post-treatment Leptin Levels|Leptin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|two months post-treatment||||ng/mL||Standard Deviation|Mean
1243526|NCT00555750|Secondary|Pre-Treatment Leptin Levels|Leptin Levels prior to two months treatment with eszopiclone or placebo, measure after an overnight fast|baseline||||ng/mL||Standard Deviation|Mean
1243527|NCT00555750|Secondary|Change in HbA1c Levels|Difference in HbA1c levels following two months treatment with eszopiclone versus placebo|baseline and 2 months post-treatment||||percentage of glycosylation||Standard Error|Mean
1243528|NCT00555750|Secondary|Change in Glucose Effectiveness (SG)|"Glucose effectiveness was defined as the ability of glucose itself to enhance its own disappearance independent of an increment in insulin. [R. Bergman, Horm Res 2005;64(suppl 3):8-15].~SG calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)"|baseline and 2 months post-treatment||||min^-1||Standard Deviation|Mean
1243530|NCT00555750|Secondary|Acute Insulin Response to Glucose (AIRg)|Change over two months in 1st phase Insulin secretion|baseline and 2 months post-treatment||||mU*l^-1*min||Standard Deviation|Mean
1243531|NCT00555750|Primary|Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test|Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.|baseline and 2 months post-treatment||||%/min, slope of natural log glucose||Standard Deviation|Mean
1243532|NCT00555672|Secondary|Progression-Free Survival (PFS)|Median time (50%) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30.|Baseline up to Month 15|Efficacy|||Months||95% Confidence Interval|Median
1243533|NCT00555672|Secondary|Duration of Response (DR)|Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30.|Baseline up to Month 15|Efficacy; N=number of participants with objective response.|||Months||Standard Deviation|Mean
1243534|NCT00555672|Secondary|Number of Participants With Objective Response|Number of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Day 21 of every even-numbered cycle up to 15 Months|Efficacy: all participants enrolled in the study who received at least 1 dose of study medication. N=number of participants with measurable disease at baseline.|||Participants|||Number
1243535|NCT00555672|Secondary|Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU|Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||ng*h/mL||Standard Deviation|Mean
1243536|NCT00555672|Secondary|Clearance (CLss) of 5-FU|Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=the number of participants contributing to the summary statistics. CLss calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||Liters per hour||Standard Deviation|Mean
1243537|NCT00555672|Secondary|Infusion Rate (Zero Order) (R0) of 5-FU|Infusion rate of 5-FU equals total dose divided by infusion time.|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N= number of participants contributing to the summary statistics. R0 calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||mg/hr||Standard Deviation|Mean
1243538|NCT00555672|Secondary|Steady State Concentration (Css) of 5-Fluorouracil (5-FU)|Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||ng/mL||Standard Deviation|Mean
1243539|NCT00555672|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).|Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)|PK; N=the number of participants contributing to the summary statistics. Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||hours||Full Range|Median
1243540|NCT00555672|Secondary|Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]|Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).|Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)|PK; N=the number of participants contributing to the summary statistics. AUC(0-24) of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the maximum tolerated dose (MTD; 25 mg Sunitinib).|||ng*h/mL||Standard Deviation|Mean
1243541|NCT00555672|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)|Pharmacokinetic (PK): participants who received Sunitinib and had sufficient plasma concentration data for calculation of PK parameters; N=number of participants contributing to summary statistics. Cmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at maximum tolerated dose.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1243542|NCT00555672|Primary|Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)|The incidence of DLTs assessed during the first cycle (21 days).|Cycle 1 (Baseline to Day 21)|Safety: enrolled participants who received at least 1 dose of study drug.|||Participants|||Number
1243543|NCT00555620|Secondary|Progression-Free Survival (PFS)|PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline up to Month 15|Efficacy analysis subset of population of participants who had an event|||months||95% Confidence Interval|Median
1243544|NCT00555620|Secondary|Duration of Response (DR)|DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.|Baseline up to Month 15|Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 reporting group analyzed; all had stable disease during specified time frame|||months||Full Range|Median
1243545|NCT00555620|Secondary|Percentage of Participants With Objective Response|Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Day 21 of every even-numbered cycle up to 15 months|Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).|||percentage of participants||95% Confidence Interval|Number
1243546|NCT00555620|Secondary|AUClast for 5-FU|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
1243547|NCT00555620|Secondary|AUClast for 5'DFUR|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
1243548|NCT00555620|Secondary|AUClast for 5'DFCR|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
1243549|NCT00555620|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
1243550|NCT00555620|Secondary|Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU|AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)|Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
1243551|NCT00555620|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
1243552|NCT00555620|Secondary|Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)|Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.|Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
1243553|NCT00555620|Secondary|t1/2 for 5-FU|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||hr||Standard Deviation|Mean
1243554|NCT00555620|Secondary|t1/2 for 5'DFUR|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||hr||Standard Deviation|Mean
1243555|NCT00555620|Secondary|t1/2 for 5'DFCR|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||hr||Standard Deviation|Mean
1243556|NCT00555620|Secondary|t1/2 for CAP|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||hr||Standard Deviation|Mean
1243557|NCT00555620|Secondary|Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.||||||
1243558|NCT00555620|Secondary|Tmax for 5-FU||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hr||Full Range|Median
1243559|NCT00555620|Secondary|Tmax for 5'DFUR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hr||Full Range|Median
1243560|NCT00555620|Secondary|Tmax for 5'DFCR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hr||Full Range|Median
1243561|NCT00555620|Secondary|Tmax for CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hr||Full Range|Median
1243562|NCT00555620|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hour (hr)||Full Range|Median
1243564|NCT00555620|Secondary|Cmin of 5'DFUR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243565|NCT00555620|Secondary|Cmin of 5'DFCR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243566|NCT00555620|Secondary|Cmin of CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243567|NCT00555620|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243568|NCT00555620|Secondary|Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243569|NCT00555620|Secondary|Cmax of 5’-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243570|NCT00555620|Secondary|Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243571|NCT00555620|Secondary|Cmax of CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
1243572|NCT00555620|Secondary|Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1243573|NCT00555620|Primary|Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)|Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21|DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.|||participants|||Number
1243574|NCT00555581|Secondary|Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire: Physical Component Summary|The Short Form 36 (SF-36) is a 36 item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. The physical component score is composed of a subset of the 8 health domains.The SF-36 physical component can be obtained by looking at the mean average of all the physically relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. Change in Short Form 36 physical component (SF-36 PC) is measured by Mean change (and 95 % Confidence Interval) from Baseline mean to Month 12 mean (the average change in SF-36 physical component from baseline to month 12).|12 months||||units on a scale||95% Confidence Interval|Mean
1243575|NCT00555581|Secondary|Scleroderma Health Assessment Questionnaire Disability Index|"The Scleroderma Health Assessment Questionnaire (SHAQ) consist of the Health Assessment Questionnaire (HAQ) and 8 other domains which include scales looking at pain, patient global assessment, vascular, digital ulcers, lung involvement, and gastrointestinal involvement. It addresses scleroderma related manifestations that contribute to disability. It is a quality of life measure. Each question is scored from 0 (without difficulty) to 3 (unable to do). Some domains in the SHAQ are visual analog scales that are measured first and then changed to a 0-3 scale.~The maximum from each category is added together and divided by the number of categories completed. Change in Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) is measured as Mean Change (and 95% Confidence Interval) from Baseline mean to Month 12 mean (the average change in SHAQ-DI from baseline to month 12)."|12 months||||units on a scale||95% Confidence Interval|Mean
1243589|NCT00555438|Secondary|Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days|Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days.|at 1 month ± 5||||participants|||Number
1243590|NCT00555438|Secondary|Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10|Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10.|10 days||||participants|||Number
1243576|NCT00555581|Secondary|Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire:Mental Component Summary|The Short Form 36 (SF-36) is a validated 36 item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. The mental component score is composed of a subset of the 8 health domains. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.The SF-36 mental component can be obtained by looking at the mean average of all the emotionally relevant items. Change in Short Form 36 mental (SF-36 MC) is measured by Mean change (and 95 % Confidence Interval) from Baseline mean to Month 12 mean (the average change in SF-36 mental component from baseline to month 12).|12 months||||units on a scale||95% Confidence Interval|Mean
1243577|NCT00555581|Secondary|Improvement in Indices of Pulmonary Function Measured by Change DLCO hb Adj % Predicted|This outcome measure includes patients with and without the presence of Interstitial Lung Disease (ILD). Diffusion capacity of the lungs for carbon monoxide (DLCO) measures how much oxygen travels from the alveoli of the lungs to the blood stream. DLCO is adjusted for hemoglobin as small changes in hemoglobin concentration can affect the carbon monoxide transfer. DLCO results are compared to normal values for a patient's height, age, sex, and ethnicity. A DLCO result that is at least 80% of the predicted value is considered normal. Improvement in DLCO hb adj % predicted is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean (the average change in DLCO hb adj% from baseline to month 12).|12 months||||DLCO%||95% Confidence Interval|Mean
1243578|NCT00555581|Secondary|Improvement in Indices of Pulmonary Function Measured by Change in FVC % Predicted|This outcome measure includes patients with and without the presence of Interstitial Lung Disease (ILD). Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking a deep breath. It is used to determine the severity of lung disease. Improvement in FVC % predicted is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean. Results are compared to the predicted values that are calculated from a patients age, size, weight, and sex. Results are considered normal if FVC is 80 percent or more of the predicted value. Mean change in FVC % predicted is measured by the average change in FVC% percent predicted from baseline to month 12.|12 months||||FVC%||95% Confidence Interval|Mean
1243579|NCT00555581|Primary|Improvement in the Modified Rodnan Skin Score|Improvement in the Modified Rodnan Skin Score (MRSS) is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean.Measure Description: The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is 0 for uninvolved skin through 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas. The minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease. The mean change in MRSS represents the average change in total skin score from baseline to month 12.|12 months||||units on a scale||95% Confidence Interval|Mean
1243580|NCT00555568|Primary|Overall Mental Health (BASIS-24 Summary Score)|BASIS-24 refers to the 24-item Behavior and Symptom Identification Scale. Responses range from 0-4; scores range from 0-4; higher values indicate greater symptom severity.|3 months||||units on a scale||Standard Deviation|Mean
1243581|NCT00555568|Primary|VR-12 MCS|VR-12 MCS refers to the Mental Health Component of the SF-12. The rating scale varies depending on the item. Scores range from 0-100; higher values indicate better mental health;|3 months||||units on a scale||Standard Deviation|Mean
1243582|NCT00555568|Primary|Social Support|Social Support was assessed by the Medical Outcomes Study Social Support Survey. Response options range from 1-5 and scores range from 19-95. Higher scores indicate greater social support|3 months||||units on a scale||Standard Deviation|Mean
1243583|NCT00555568|Primary|Empowerment|Empowerment is measured by the “Making Decisions” instrument. Response options range from 1-4 and scores can range from 28-112. Higher scores indicate more empowerment.|3 months||||units on a scale||Standard Deviation|Mean
1243584|NCT00555568|Primary|Patient Activation|"Patient activation refers to patient knowledge skill and confidence for self-management.~Full name of the scale is Patient Activation Measure (PAM). Scale response options range from 1-4 and scores can range from 13-52. Higher values indicate greater activation. No subscales are used."|3 months||||units on a scale||Standard Deviation|Mean
1243585|NCT00555477|Primary|The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy|In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml.|12 months||||participants|||Number
1243586|NCT00555464|Secondary|Toxicity to Medications|"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.~Please see Adverse Events module for more details."|Initial visit, 2, 4, 6, 10 and 12 weeks of therapy||||participants|||Number
1243587|NCT00555464|Primary|Response of Hemangioma (IH) to Treatment|"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.~Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.~Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume."|6 weeks|Per protocol, all participants were analyzed, no matter the treatment arm or treatment success.|||participants|||Number
1243588|NCT00555438|Secondary|Death at 1 Month ± 5 Days|Evaluate the total number of death at 1 month ± 5 days|1 month ± 5 days||||participants|||Number
1243591|NCT00555438|Secondary|Number of Patients With Major Bleedings at 1 Month ± 5 Days.|evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days.|45 day||||participants|||Number
1243592|NCT00555438|Primary|Number of Patients With Major Bleedings Between Day 1 and Day 10.|evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L.|10 day||||participants|||Number
1243593|NCT00555425|Secondary|Health Status|Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|18 weeks|Results are provided on those individuals who completed this assessment|||units on a scale||Standard Deviation|Mean
1243594|NCT00555425|Secondary|Patient Satisfaction|Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction.|18 weeks|Results are provided on those individuals who completed this assessment|||units on a scale||95% Confidence Interval|Mean
1243595|NCT00555425|Secondary|Changes in HIV Risk|"As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse).~There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales.~Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status."|Baseline and 18 weeks||||units on a scale||Standard Deviation|Mean
1243596|NCT00555425|Secondary|Reduction in Cocaine Use|As measured by the percent of provided urines positive for cocaine|18 weeks||||percent of cocaine positive urines||Standard Deviation|Mean
1243597|NCT00555425|Secondary|Retention in Treatment|Mean number of days from randomization to last clinical contact|18 weeks||||number of days||95% Confidence Interval|Mean
1243598|NCT00555425|Secondary|Proportion of Patients Protectively Transferred|>= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study|18 weeks||||participants|||Number
1243599|NCT00555425|Primary|Illicit Opioid Use|Urinalysis based on scheduled weekly urine screenings during treatment period|18 weeks||||percent of opioid negative urine samples||95% Confidence Interval|Mean
1243600|NCT00555360|Secondary|Adherent to Heart Failure Medication|Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.|twelve-month follow-up||||percentage of participants/perfect adher|||Number
1243601|NCT00555360|Secondary|Revised Heart Failure Self-Care Behavior Scale (HFSCB)|Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.|twelve-month follow-up||||units on a scale||Standard Deviation|Mean
1243602|NCT00555360|Primary|Heart Failure-specific Quality of Life|Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.|twelve-month followup||||units on a scale||Standard Deviation|Mean
1243603|NCT00555321|Secondary|Change in Protein to Creatinine Ratio From Month 3 to Month 12.||Month 3 and 12|Protein creatinine ratio change was not analyzed||||||
1243604|NCT00555321|Secondary|Number of Participants Who Had Abnormalities in Electrocardiograms: 12-month Treatment Phase||Baseline (pretransplant), Week 52|ECG data was not analyzed.||||||
1243605|NCT00555321|Secondary|Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase|Low total calcium: <7 mg/dL; High total calcium: >12.5 mg/dL ; Low bicarbonate: <11 mEq/L; Low serum potassium: <3.0 mEq/L; High serum potassium:>6.0 mEq/L; High serum magnesium: >2.46 mEq/L; Low serum magnesium:<0.8 mEq/L; Low serum sodium: <130 mEq/L; High serum sodium: >155 mEq/L; Low inorganic phosphorus: <2.0 mg/dL; Low albumin: <2 g/dL; High uric acid: >10 mg/dL|Baseline (pretransplant), Weeks 4, 12, 24, and 52|ITT population, all randomized and transplanted participants. n= participants with all observations.|||participants|||Number
1243606|NCT00555321|Secondary|Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase|ULN= upper limit of normal; Normal ranges are provided by the central laboratory and may vary according to sex and age. High alkaline phosphatase (ALP): >5.0*ULN U/L; High alanine aminotransferase (ALT): >5.0*ULN U/L; High aspartate aminotransferase (AST): >5.0*ULN U/L; High direct bilirubin: >3.0 * ULN mg/dL; High g-glutamyl transferase (GGT): >5.0*ULN U/L; High total bilirubin: >3.0*ULN mg/dL; High creatinine: > 3.0*ULN mg/dL|Baseline (pretransplant), 4, 12, 24, 52 weeks|ITT population, all randomized and transplanted participants. n= participants with all observations.|||participants|||Number
1243607|NCT00555321|Secondary|Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase|Low hemoglobin: <8 g/dL; Low platelet count: <50*10^9 C/L; Low leukocytes: <2.0 *10^3 c/µL; Low lymphocytes (absolute): <0.5*10^3 c/µL; Low neutrophils (absolute): <1.0*10^3 Cc/µL.|Baseline (pretransplant), 2, 4, 8, 12 weeks, and every 4 weeks for week 16 to 52|ITT population, all randomized and transplanted participants. n= participants with all observations.|||participants|||Number
1243608|NCT00555321|Secondary|Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase|AE of of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial), serious infections|Day 1 (randomization) to 12 months or ≤ 56 days after discontinuation of study medication|ITT population, all randomized and transplanted participants.|||participants|||Number
1243609|NCT00555321|Secondary|Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event|Day 1 (randomization) to 12 m + 8 week follow-up or ≤ 56 days after discontinuation of study medication|ITT population: all randomized and transplanted participants|||participants|||Number
1243610|NCT00555321|Secondary|Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase|The HbA1c test is important in diabetes as a long-term measure of control over blood glucose, where the glucose bound to hemoglobin during the past 3-4 months is measured. A baseline diabetes participant was one who had a medical history of diabetes or being under anti-diabetic medication at the time of the transplantation. BL = baseline, DM = Diabetes mellitus.|6, 12 months (mth) posttransplant|ITT population, all randomized and transplanted participants. n = Participants with both baseline and postbaseline values.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
1243611|NCT00555321|Secondary|Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase|A participant who did not have diabetes prior to randomization was determined to have NODM if(i) the participant received an antidiabetic medication for a duration of at least 30 days or(ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is>=126 mg/dL (7.0 mmol/L). For 95% CI within each group, normal approximation is used if N>=5. For 95% CI of difference, adjustment is made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm.|6 and 12 months posttransplant|ITT population, all randomized participants without Diabetes Mellitus (pre-transplantation).|||percentage of participants||95% Confidence Interval|Number
1243612|NCT00555321|Secondary|Number of Participants Who Received Anti-hypertensive Therapy at Month 12||12 months posttransplant|ITT population, all randomized and transplanted participants.|||participants|||Number
1243613|NCT00555321|Primary|Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE|Low Serum Potassium: <3.0 meq/L; High serum potassium:>6.0 mEq/L; Low serum magnesium:<0.8 mEq/L; Low serum sodium: <130 mEq/L; High serum sodium: >155 mEq/L; Low inorganic phosphorus: <2.0 mg/dL; High uric acid: >10 mg/dL|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.|||participants|||Number
1243614|NCT00555321|Primary|Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE|ULN= upper limit of normal; Normal ranges are provided by the Central Laboratory and may vary according to sex and age. High alanine aminotransferase (ALT): >5.0*ULN U/L; High aspartate aminotransferase (AST): >5.0*ULN U/L; High direct bilirubin: >3.0*ULN mg/dL; High g-glutamyl transferase (GGT): >5.0*ULN U/L; High total bilirubin: >3.0*ULN mg/dL; High creatinine: > 3.0*ULN mg/dL|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.|||participants|||Number
1243615|NCT00555321|Primary|Number of Participants With Marked Hematology Abnormalities During the LTE|Low platelet count: <50*10^9 c/µl; Low leukocytes: <2.0*10^3 c/µl; Low lymphocytes (absolute): <0.5*10^3 c/µl; Low neutrophils (absolute): <1.0*10^3 c/µl.|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.|||participants|||Number
1243616|NCT00555321|Primary|Number of Participants Who Had AEs of Special Interest During the LTE|AE of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial).|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension|||participants|||Number
1243617|NCT00555321|Primary|Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011)|ITT-LTE population, (all randomized and transplanted participants who entered long term extension). Participants were grouped according to the treatment to which they were randomized initially.|||participants|||Number
1243618|NCT00555321|Secondary|Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase|Percentage of participants at any given time who meet the definition of hypertension. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
1243619|NCT00555321|Secondary|Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase|Percentage of participants who develop hypertension after randomization and transplantation. Transient post-operative increases in BP were not to be counted as new onset hypertension. Hypertension was to be assessed only at or after the Week 4 visit. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
1243620|NCT00555321|Secondary|Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase||BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mm Hg||Standard Deviation|Mean
1243621|NCT00555321|Secondary|Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase|Participants were considered to have hypertension if they had Diastolic Blood Pressure (SBP) ≥ 80 mmHg.|BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mm Hg||Standard Deviation|Mean
1243622|NCT00555321|Secondary|Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase||Baseline (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mm Hg||Standard Deviation|Mean
1243623|NCT00555321|Secondary|Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
1243624|NCT00555321|Secondary|Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants.|||mg/dL||Standard Deviation|Mean
1243625|NCT00555321|Secondary|Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
1243626|NCT00555321|Secondary|Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
1243627|NCT00555321|Secondary|Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
1243628|NCT00555321|Secondary|Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase|Percentage of participants at any given time (at Month 6 and Month 12) who met the definition of dyslipidemia.Dyslipidemia is defined as hypertriglyceridemia (TGs ≥ 500 mg/dL [5.65 mmol/L]), hypercholesterolemia (LDL ≥ 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL ≥ 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs ≥ 200 mg/dL [2.26 mmol/L]).|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
1243629|NCT00555321|Secondary|Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase|Percentage of participants who develop dyslipidemia, defined as hypertriglyceridemia (triglycerides [TGs] ≥ 500 mg/dL [5.65 mmol/L]), hypercholesterolemia (Low density lipoprotein [LDL] ≥ 100 mg/dL [2.59 mmol/L]), or elevated non-high density lipoprotein (non- high density lipoprotein [HDL] ≥ 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs ≥ 200 mg/dL [2.26 mmol/L]).|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants who did not have dyslipidemia at baseline|||percentage of participants||95% Confidence Interval|Number
1243630|NCT00555321|Secondary|Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE|Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels > 2.4 x 10^6 U/mL and > 4.7 x 10^6 U/mL were descriptively summarized by treatment group. BL = baseline|BL (pretransplant), 12, 18, 24, 30 months (mo) posttransplant|ITT-LTE population, all randomized and transplanted participants. n= participants with HCV RNA values.|||participants|||Number
1243631|NCT00555321|Secondary|Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase|Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels > 2.4 * 10^6 U/mL and > 4.7 * 10^6 U/mL were descriptively summarized by treatment group. BL=baseline|Baseline (pretransplant), 6 and 12 months (mo) posttransplant|ITT population, all randomized and transplanted participants. n= participants who were HCV positive at baseline.|||participants|||Number
1243632|NCT00555321|Secondary|Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE|HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score >= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score >= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N>=5 in both arms, otherwise exact method was used.|12 months posttransplant, end of study (database lock, 20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long-term extension.|||percentage of participants||95% Confidence Interval|Number
1243633|NCT00555321|Secondary|Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months|HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score >= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score >= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N>=5 in both arms, otherwise exact method was used.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
1243702|NCT00554840|Primary|Change of ExpiredCO Level From Baseline|End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.|Weekly for 12 weeks|Some ExpiredCO data is missing due to rater error or participant absence from that study visit.|||ppm||Standard Deviation|Mean
1243634|NCT00555321|Secondary|Belatacept Trough Concentration Before Each Infusion During the LTE|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.|Samples were collected predose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105, 532, 728.|All randomized participants who received Belatacept, and had complete PK profile. n= participants with values at all time points.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1243635|NCT00555321|Secondary|Belatacept PK Parameter: Clearance From Ascites Fluid|Clearance from ascites fluid was determined by amount excreted in ascites fluid (Ae, asc)[0-T] / AUC[0-T], where 0-T is the same duration relative to a belatacept infusion.|Days 1 to 14|Serum AUC was not available for the time interval corresponding to ascites fluid collection.||||||
1243636|NCT00555321|Secondary|Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14|Amount Excreted in Ascites (Ae,asc) was estimated from the ascites drug concentrations and volumes within a dosing interval.|Days 1 to 14|All randomized participants who received belatacept, and had complete PK profile.|||µg||Standard Deviation|Mean
1243637|NCT00555321|Secondary|Belatacept PK Parameter: Volume of Distribution|Volume of distribution (Vss) is the volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration. . Vss was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||L/kg||Standard Deviation|Mean
1243638|NCT00555321|Secondary|Belatacept PK Parameter: Total Body Clearance|Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. CLT was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
1243639|NCT00555321|Secondary|Belatacept PK Parameter: Terminal Half-life|Terminal Half-life (T 1/2) is the time a drug takes for the concentration levels to fall to 50% of their value.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||hour||Standard Deviation|Mean
1243640|NCT00555321|Secondary|Belatacept PK Parameter: Minimum Plasma Concentration|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1243641|NCT00555321|Secondary|Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau)|Area under the plasma concentration-time curve for each dosing interval is determined using the linear trapezoidal rule. The AUC(TAU) of belatacept from the MI regimens and LI regimens were calculated over 2 and 4 weeks respectively.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1243642|NCT00555321|Secondary|Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration|Maximum Plasma Concentration (Tmax) is the time taken to reach the maximum observed plasma concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||hour||Full Range|Median
1243643|NCT00555321|Secondary|Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration|Maximum Plasma Concentration (Cmax) is the maximum observed serum drug concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1243644|NCT00555321|Secondary|Mean Change in Baseline Values of Cystatin C at 2 and 12 Months|Cystatin C is a protein encoded by the CST3 gene, which is mainly used as a biomarker of kidney function. If kidney function and glomerular filtration rate decline, the blood levels of cystatin C rise.|Baseline (pretransplant), 2, and 12 months posttransplant|ITT population: all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/L||Standard Deviation|Mean
1243645|NCT00555321|Secondary|Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12|Measurement of SCr is commonly used as an indicator of renal function. High creatinine blood level is an indicator of deficient filtering by the kidney. SCr was determined at baseline and various post-baseline time points.|Baseline (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant|ITT population, all randomized and transplanted participants. n= participants who have both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
1243646|NCT00555321|Secondary|Mean Change From Baseline in Calculated GFR During the LTE|GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m^2) = 170*(Scr)^-0.999*(Age)^-0.176*(0.762 if female)*(1.180 if African American)*(BUN)^-0.170*(Alb)^+0.318. ). BL= baseline, mL= milliliters; min= minute; m^2= meters squared.|Baseline (pretransplant time point), 1, 2, 3, 6,12, 18, 24, 30, 36 months posttransplant|ITT-LTE population, all randomized and transplanted participants who entered long term extension. n= participants who have both baseline and postbaseline values.|||mL/min/1.73 m^2||Standard Deviation|Mean
1243703|NCT00554801|Secondary|Quality of Life Questionnaire|Self-report questionnaires regarding quality of life|Three years|It was decided early during implementation of this study that the investigators would not collect self-report data on quality of life, so there are no data to report||||||
1243647|NCT00555321|Secondary|Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase|GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m^2) = 170*(Scr)^-0.999*(Age)^-0.176*(0.762 if female)*(1.180 if African American)*(BUN)^-0.170*(Alb)^+0.318. ). BL= baseline, mL= milliliters; min= minute; m^2= meters squared.|Baseline [BL] (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mL/min/1.73 m^2||Standard Deviation|Mean
1243648|NCT00555321|Secondary|Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase|GFR was assessed using a true measure of glomerular filtration via iothalamate clearance test. The month 2 time point was selected as the “baseline” time point with respect to measured GFR due to logistical difficulty in obtaining measured GFR at the time of liver transplant and post-transplant renal function largely stabilizing by 2 months. All Measured GFR > 200 were truncated at 200.|Baseline (2 month), 12 months posttransplant|ITT population: all randomized and transplanted subjects. n = participants who had both baseline and postbaseline values.|||mL/min/1.73m^2||Standard Deviation|Mean
1243649|NCT00555321|Secondary|Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months|The time from transplantation to the first AR episode in each treatment arm was summarized using Kaplan-Meier curves. Acute Rejections were clinically suspected and biopsy proven by central pathologist.|3, 6, 9 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||participants|||Number
1243650|NCT00555321|Secondary|Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE|Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.|Day 1 (randomization) through End of study (database lock of 20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered the long-term extension phase.|||participants|||Number
1243651|NCT00555321|Secondary|Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months|Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants|||participants|||Number
1243652|NCT00555321|Secondary|Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months|Acute Rejections (AR) were clinically suspected and biopsy proven by central pathologist. The Banff grading is a classification of renal allograft pathology and AR. Grade I: AR requiring moderate (>25%) to severe mononuclear cell interstitial infiltrate and moderate tubulitis; Grade II: AR requiring severe tubulitis and/or intimal arteritis; Grade III: AR requiring transmural arteritis. Only the episode with highest Banff grade for each participant was counted.|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants|||participants|||Number
1243653|NCT00555321|Secondary|Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE|Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. DBL=database lock, TRT=treatment|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension.|||participants|||Number
1243654|NCT00555321|Secondary|Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months|Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. TRT= treatment|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants|||participants|||Number
1243655|NCT00555321|Secondary|Number of Participants Having Acute Rejections During the LTE|Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long-term extension|||participants|||Number
1243656|NCT00555321|Secondary|Number of Participants Having Acute Rejections: 12-month Treatment Phase|Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.|3 , 6, and 12 months|ITT population: all randomized and transplanted participants|||participants|||Number
1243657|NCT00555321|Secondary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data)|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a central histopathologist using Banff criteria. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population: all randomized and transplanted participants who entered the Long term extension|||percentage of participants||95% Confidence Interval|Number
1243658|NCT00555321|Secondary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% CI within each group, normal approximation is used if N>=5. Otherwise exact method is used. For 95% CI of difference, adjustment is made for randomization strata if N >= 5 in each treatment arm.|At 12 months posttransplant|ITT population: all randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1243659|NCT00555321|Secondary|Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data)|For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension.|||percentage of participants||95% Confidence Interval|Number
1243660|NCT00555321|Secondary|Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase|For 95% CI within each group, normal approximation was used if N>=5. Otherwise exact method was used.|At 6 and 12 months|ITT population: all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
1243661|NCT00555321|Primary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading schema. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% (confidence interval) CI within each group, normal approximation is used if N>=5, otherwise exact method is used.|At 6 months posttransplant|Intent-to-Treat (ITT) population: all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
1243662|NCT00555217|Secondary|A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD.|Time to the first event of reduction in estimated GFR of >50% (for individuals with baseline GFR <60) or reduction in GFR of >30 (for individuals with baseline GFR >= GFR 60) or ESRD.|From enrollment to time of first event, up to 4.5 years||||participants|||Number
1243663|NCT00555217|Primary|A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death|Time to the first event of reduction in estimated GFR of 30ml/min/1.73m*m in individuals w/a baseline estimated GFR >= 60 ml/min/1.73m*m, reduction in estimated GFR >50% in individuals w/ baseline estimated GFR <60ml/min/1.73m*m; ESRD or death.|From enrollemnt to time of first primary event, up to 4.5 years||||participants|||Number
1243664|NCT00555152|Primary|Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0|Toxicity profile summarized reflects incidence by number of participants affected with adverse events by Maximum Grade 1 to 3, additional adverse event according to the NCI CTCAE version 3.0 reported in Adverse Event section results.|From baseline to 4-5 weeks after surgery||||participants|||Number
1243665|NCT00555152|Secondary|Biomarker Analysis of Proliferation Markers|Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.|2-6 weeks from baseline to surgery, Up to 6 weeks|No outcome data available due to laboratory issues affecting the analysis of biomarkers results.||||||
1243666|NCT00555152|Secondary|Incidence of Ductal Carcinoma in Situ Remaining at Resection|Number of participants with DCIS incidence on surgical excision. Differences in histologic response (disappearance of DCIS) will be evaluated using Fisher’s exact test. Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.|2-6 weeks from baseline to surgery, up to 6 weeks|DCIS was present at the time of surgery in all patients.|||participants|||Number
1243667|NCT00555152|Primary|Proliferation (Ki67 IHC) in Ductal Breast Carcinoma In Situ (DCIS)|Reduction in percent of Ki67 positive cells at surgery compared to baseline as a function of treatment. Analysis of the primary treatment comparison will be based on a two sample t-test comparing change in log-transformed Ki67% for placebo and treated subjects. P-values of 0.05 will be considered significant. Proliferation will be assessed by immunohistochemical (IHC) staining for Ki67, and the change in percentage of Ki67 positive cells will be compared in lapatinib-treated samples versus placebo.|2-6 weeks from baseline to surgery, up to 6 weeks|No outcome data available due to laboratory issues affecting the analysis of biomarkers results.||||||
1243668|NCT00555061|Secondary|Number of Participants by Age With Therapeutic Response of Success|"Therapeutic response is a measure of the overall efficacy response; a response of therapeutic success was based on both clinical success and bacteriological success in a given participant."|Follow-up, Days 12 to 16|ITTB and ITTC Populations. The number analyzed is the number of participants who were clinical successes both in the ITTC Population and the ITTB Population; the number of participants who were therapeutic successes out of the total number in each respective category is shown.|||participants|||Number
1243669|NCT00555061|Secondary|Bacteriological Success Rate at Follow-up, by Baseline Pathogen|"Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as n in the category title) for each respective category is shown."|Follow-up, Days 12 to 16|ITTB (Intent-to-Treat Bacteriological) Population: participants who had at least one dose of study medication and a clinical diagnosis of infection plus a pathogen isolated at Baseline. Participants with more than one pathogen may be represented in the table more than once.|||number of pathogens eradicated|||Number
1248047|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 96 weeks||||liters||Standard Error|Least Squares Mean
1243670|NCT00555061|Secondary|Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age|SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed.|Follow-up, Days 12 to 16|Intent-to-Treat Clinical (ITTC) Population: all participants who received at least one dose of study medication; the number of participants who were clinical successes out of the total number in each respective category is shown|||participants|||Number
1243671|NCT00555061|Primary|Number of Participants With Measurable Plasma Concentrations, by Age Group|Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.|Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day|Pharmacokinetic (PK) Population: all participants who received at least one dose of study medication and who had PK samples taken. Seven participants did not have PK samples collected.|||participants|||Number
1243672|NCT00555048|Secondary|Graft Failure|Count of participants with graft failure at day 100|Up to day 100||||Participants|||Count of Participants
1243673|NCT00555048|Secondary|Extensive Chronic GVHD|Count of participants with extensive chronic GVHD at 1 year|Up to 1 year||||Participants|||Count of Participants
1243674|NCT00555048|Secondary|Disease Relapse|Count of participants with disease relapse at 1 year|Up to 1 year||||Participants|||Count of Participants
1243675|NCT00555048|Secondary|Overall Survival|Count of surviving participants at 1 year|Up to 1 year||||Participants|||Count of Participants
1243676|NCT00555048|Secondary|Grades III-IV Acute Graft-vs-host Disease (GVHD)||Up to 100 days||||Participants|||Count of Participants
1243677|NCT00555048|Secondary|Life-threatening Infection||Up to 180 days||||Participants|||Count of Participants
1243678|NCT00555048|Primary|Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality|Lowest dose of alemtuzumab associated with transplant-related mortality at day 180|Up to day 180||||mg total dose|||Number
1243679|NCT00555009|Secondary|Change From Baseline in Waist Circumference||Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||cm||Standard Deviation|Mean
1243680|NCT00555009|Secondary|Change From Baseline in Weight||Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||kg||Standard Deviation|Mean
1243681|NCT00555009|Secondary|Change From Baseline in Cardiovascular Risk|The cardiovascular risk parameters (low-density lipoprotein-cholesterol, high-density lipoprotein cholesterol, total cholesterol and fasting triglycerides) was measured at all visits (Weeks 2, 4, 12, 24, and 36).|Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
1243682|NCT00555009|Secondary|Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36|The AGHDA is a quality of life subject-administered questionnaire that is condition-specific and comprises of 25 ‘Yes’ or ‘No’ statements covering 6 dimensions – mobility, pain, energy, sleep, emotional reactions and social isolation. The AGHDA total score change from Baseline values is calculated as the difference between the total score at Visit 6 (Week 36), and the total score at Baseline.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
1243683|NCT00555009|Secondary|Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36|A subject administered scale assessing general quality of life. A subject administered score, scale, direction of scale. The SF-36 consists of 36 questions covering the following eight health domains (subscales): Physical Functioning, Bodily Pain, Role Limitations Due to Physical Problems, Role Limitations Due to Emotional Problems, General Health Perceptions, Mental Health, Social Function, Vitality.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||score on a scale||Standard Deviation|Mean
1243684|NCT00555009|Secondary|Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36|The GOS is widely used for assessing outcome after head injury and non-traumatic acute brain insults and is performed by a physician. The GOS-E uses eight points to assess disability and handicap. The GOS-E focuses on how the injury has affected functioning in major areas of life rather than on the particular deficits and symptoms caused by injury. The overall score ranges from 1-8; 1=Death and 8=Upper Good Recovery|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
1243685|NCT00555009|Secondary|Change From Baseline in Lean Body Mass and Fat Mass at Week 36|The change from Baseline values for lean body mass and fat mass is calculated as the difference between the parameter values at Visit 36, and the parameter values at Baseline.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||kg||Standard Deviation|Mean
1243686|NCT00555009|Secondary|Change From Baseline in CogState™ at Week 12 and 24.|CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.|Baseline, Week 12 and 24|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
1243701|NCT00554840|Primary|Level of Nicotine Dependence by Treatment Assignment|Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.|Weekly for 12 weeks|Some FTND data is missing due to rater error or participant absence from that study visit.|||units on a scale||Standard Deviation|Mean
1243687|NCT00555009|Primary|Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36|CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
1243688|NCT00554996|Primary|Rate of UTI While Colonized With E. Coli 83972.|Rate of UTI during colonization with E. coli 83972.|0-266 days of colonization|Number of UTIs per 1000 patient-days during colonization with E. coli 83972.|||UTIs per 1000 patient-days|||Number
1243689|NCT00554970|Primary|Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.|||min||Standard Deviation|Mean
1243690|NCT00554970|Primary|Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.|||min||Standard Deviation|Mean
1243691|NCT00554970|Primary|AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.|||pg*min/ml||Standard Deviation|Mean
1243692|NCT00554970|Primary|AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.|||pg*min/ml||Standard Deviation|Mean
1243693|NCT00554970|Primary|Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Mean
1243694|NCT00554970|Primary|Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Mean
1243695|NCT00554853|Secondary|Rheumatoid Arthritis Disease Activity|"Quantification of disease activity using validated assessments (disease activity score on 28 joints (DAS28) and and C-reactive protein ( CRP) (Inflammatory marker) as a combined score (DAS-28CRP)).~Mean decrease in DAS-28-CRP score when compared to baseline was measured. The range of DAS-28-CRP is 0-10, with 0 meaning no active disease detected and 10 being the most severe active disease detected by joint count and C-reactive protein levels in blood."|8 mo||||mean decrease in DAS28-CRP score||Standard Deviation|Mean
1243696|NCT00554853|Primary|Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia|This measure represents the percentage change in diameter of brachial artery in response to reactive hyperemia. The data is presented intentionally and only for the results at the conclusion of the study.|8 months|Vascular function parameters were performed in patients with rheumatoid arthritis at baseline and at completion of each arm , as well as at the beginning of crossover following washout period.|||% changes in diameter of artery||Inter-Quartile Range|Mean
1243697|NCT00554840|Secondary|Side Effects|Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.|Weekly for 12 weeks||||Participants|||Count of Participants
1243698|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score|"The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS anxiety/depression score data is missing due to rater error or participant absence from that study visit.|||units on a scale||Standard Deviation|Mean
1243699|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS total score data is missing due to rater error or participant absence from that study visit.|||units on a scale||Standard Deviation|Mean
1243700|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Total Score|"The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS total score data is missing due to rater error or participant absence from that study visit.|||units on a scale||Standard Deviation|Mean
1243705|NCT00554749|Secondary|Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)|6 Predefined treatment goals reflecting speaking levels from 1 through to 6. 1: Speaks to the therapist(T) in a separate room in the kindergarten with parent (P) present. 2: Speaks to T in a separate room without P. 3: Speaks to a teacher in a separate room with T present. 4: Speaks to other teachers in a separate room with T present. 5: Speaks to teachers in some kindergarten settings without T present. 6: Speaks to teachers in all settings in kindergarten without T present. Each child receives one score at end of treatment according to their acquired level (worst value=1, best value =6)|6 months|All participants analyzed|||participants|||Number
1243706|NCT00554749|Primary|School Speech Questionnaire (SSQ)|SSQ is a teacher-report measure assessing the frequency of the child's speaking behaviour at school. It is a 9-item questionnaire. Each item has four possible responses, ranging 0 (never), 1 (seldom), 2 (often) and 3 (always). The standard sum score is added up from the six questions (as defined by its author Lindsey Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3.(worst value=0 and best value=3)|6 months||||Units on a scale||Standard Deviation|Mean
1243707|NCT00554671|Secondary|Health-care Costs to the VHA|"The reported values represent the Total VHA expenditure per person. Institutional costs from health service utilization on the study patients during and 13 months after the intervention. Baseline is considered time 0."|13 months (during study) and 13 months (after the study) = 26 months|117 patients randomized to Pharmacist-led Group Medical Visits. 133 patients were randomized to Usual care.|||United States Dollar||Standard Deviation|Mean
1243708|NCT00554671|Secondary|Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment|Medical Outcomes Study 36-Item Short Form Survey (SF-36) is a popular, multi-purpose health status survey that addresses quality of life from physical and mental health perspectives. SF-36v is the survey adapted for veterans. Items are summed and averaged in two subscores, the Physical Composite Summary Score and the Mental Composite Summary Score, and scaled to a range of 0 to 100, with lower scores denoting poorer health.|Baseline and 13 months|117 patients randomized to Pharmacist-led Group Medical Visits, 2 patients died before study end date and 18 patients dropped out.133 patients randomized to Usual care, 4 patients died before study end date and 12 patients dropped out.|||Scores of SF-36v||Standard Deviation|Mean
1243709|NCT00554671|Primary|Hemoglobin A1c|hemoglobin A1c levels at 13 months|13 months||||percent Hemoglobin A1c||Standard Deviation|Mean
1243710|NCT00554671|Primary|Hemoglobin A1c|Hemoglobin A1c levels at 6 months|6 months|At the 6 month visit, some patients dropped out of the study or died.|||percent Hemoglobin A1c||Standard Deviation|Mean
1243711|NCT00554619|Primary|Number of Participants With Adverse Events Categorized by Severity|The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.|For 140.57 weeks at maximum, starting from Week 24|Safety Population|||participants|||Number
1243712|NCT00554619|Secondary|Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. BNP is a surrogate marker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||nanograms per liter (ng/L)||Standard Deviation|Mean
1243713|NCT00554619|Secondary|Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|CO is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 156.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||Liters per minute (L/min)||Standard Deviation|Mean
1243714|NCT00554619|Secondary|Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|mPAP is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1243715|NCT00554619|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event|Time to clinical worsening was defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy (a surgical procedure in which a small hole is made in the wall between the left and right atria of the heart), or study discontinuation due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events up to 164.14 weeks.|Up to 164.14 weeks|FAS|||participants|||Number
1243716|NCT00554619|Secondary|Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|There are four grades for the WHO FC (Class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||participants|||Number
1243717|NCT00554619|Secondary|Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||scores on a scale||Standard Deviation|Mean
1243718|NCT00554619|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156|Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 minus the baseline value. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Imputation technique was last observation carried forward, which was used in an attempt to compensate for missing data. For each participant, missing values were replaced with the last observed value.|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156|Full Analysis Set (FAS): All participants registered, with the exception of those who did not receive any dose of the investigational product and those who had no efficacy assessment after treatment.|||meters||Standard Deviation|Mean
1243719|NCT00554619|Primary|Number of Participants With Any Adverse Event|An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.|For 140.57 weeks at maximum, starting from Week 24|Safety Population: Participants who had received at least one dose of the investigational product|||participants|||Number
1243720|NCT00554515|Post-Hoc|Objective Response Rate (Investigator Assessment)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
1243721|NCT00554515|Other Pre-specified|VHL Genotype Status|VHL genotype status will be determined based on establish methods.|Determined from baseline sample.||2018-06-30|06/2018||||
1243722|NCT00554515|Other Pre-specified|Serum Arginine Levels|Serum arginine levels will be determined based on establish immunohistochemical methods.|Determined from baseline sample.||2018-06-30|06/2018||||
1243723|NCT00554515|Other Pre-specified|KIR Genotype Status|Killer-immunoglobulin-like receptor (KIR) genotype status determined based on establish methods.|Determined from baseline sample.||2018-06-30|06/2018||||
1243724|NCT00554515|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from treatment start to date of disease progression (PD) or death. Per WHO criteria: PD is a >/=25% increase in the sum of products of the perpendicular diameters of all measurable lesions. Further, PD is the appearance of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. Participants who were event-free were censored at the date of their last disease evaluation.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Median survival follow-up was X months (95% CI: ).|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1243725|NCT00554515|Secondary|Objective Response Rate by CA-9 SNP|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
1243726|NCT00554515|Secondary|Objective Response Rate by B7-H3 Tumor|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
1243727|NCT00554515|Secondary|Objective Response Rate by PD-L1 Tumor|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of patients||95% Confidence Interval|Number
1243728|NCT00554515|Secondary|Objective Response Rate by CA-9 Score (CAIX Classification)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
1243729|NCT00554515|Secondary|Objective Response Rate by Clear Cell Histology Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Response status was confirmed by an independent assessment of radiographs. Participants received up to 3 courses of 12 weeks duration each.|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
1243730|NCT00554515|Secondary|Objective Response Rate by Tumor Type|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
1243731|NCT00554515|Secondary|Objective Response Rate by UCLA SANI Score|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
1243732|NCT00554515|Secondary|Objective Response Rate by MSKCC Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
1248048|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 80 weeks||||liters||Standard Error|Least Squares Mean
1243733|NCT00554515|Secondary|3-Year Progression-Free Survival Rate|3-year progression-free survival rate is defined as the proportion of patients absent death or progression based on WHO criteria by 3 years since time of treatment start. PD is a >/=25% increase in the sum of products of the perpendicular diameters of all measurable lesions. Further, PD is the appearance of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Relevant for this endpoint was disease status at 3 y.|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
1243734|NCT00554515|Secondary|Overall Survival|Overall survival based on the Kaplan-Meier method is defined as the time from treatment start to date of death or censored at the date of last documented contact.|Participants were followed for survival up to 7 years.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1243735|NCT00554515|Secondary|Objective Response Rate (Independent Assessment)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks.. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
1243736|NCT00554515|Secondary|Objective Response Rate in ISM Poor Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on treatment on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data for ISM analysis and classified as ISM poor risk.|||proportion of participants||95% Confidence Interval|Number
1243737|NCT00554515|Primary|Objective Response in ISM Good Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data for ISM analysis and classified as ISM good risk.|||proportion of participants||95% Confidence Interval|Number
1243738|NCT00554463|Secondary|Median and 2-year Rates of Progression-free and Overall Survival||After all patients have been potentially followed for 2 years|||||||
1243739|NCT00554463|Secondary|Incidence of Grade 4 Thrombocytopenia||At the completion of all treatment, approximately 80 days|||||||
1243740|NCT00554463|Secondary|Incidence of Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events as Assessed by NCI CTCAE v 3.0||At the completion of all treatment, approximately 80 days|||||||
1243741|NCT00554463|Secondary|Incidence of Dose Modifications or Treatment Delays||At the completion of all treatment, approximately 80 days|||||||
1243742|NCT00554463|Secondary|Incidence of Grade 4 Neutropenia or Grades 3-4 Febrile Neutropenia Episodes During Adjuvant Chemotherapy as Assessed by NCI CTCAE v 3.0||At the completion of all treatment, approximately 80 days|||||||
1243743|NCT00554463|Primary|Incidence of Grade 4 Neutropenia or Grades 3-4 Febrile Neutropenia Episodes During Concurrent Chemoradiotherapy as Assessed by NCI CTCAE v 3.0 (Common Terminology Criteria for Adverse Events)|This study stopped accrual early with 5 accrued out of 44 planned, therefore no analyses were performed.|At the completion of all treatment, approximately 80 days|||||||
1243744|NCT00554372|Secondary|Median Overall Survival|Overall survival after treatment in days|To 760 days post treatment||||days||95% Confidence Interval|Median
1243745|NCT00554372|Secondary|Number of Subjects Achieving Disease Control as Determined Using Intrahepatic Modified RECIST Criteria|"Number of subjects achieving disease control (non-progressive disease) at 8 weeks after treatment was initiated based on modified Response Evaluation Criteria in Solid Tumors for Hepatocellular Carcinoma (mRECIST for HCC). mRECIST for HCC adopted the concept of viable tumor as tumor tissue showing uptake in arterial phase of contrast enhanced radiologic imaging techniques. (see Lencioni and Llovet, Semin. Liver Dis. 2010; 30:52-60). Per mRECIST for HCC, for target lesions as assessed by contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target (viable) lesions; Partial Response (PR), >=30% decrease in the sum of diameters of viable target lesions; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any increase of >= 20% in viable target lesions.~Disease Control (DC) = CR or PR or SD."|At week 8||||participants|||Number
1243746|NCT00554372|Secondary|Safety and Tolerability of JX-594 Administered at Two Dose Levels|Treatment-related serious adverse events in patients treated at two dose levels|Safety and tolerability were evaluated throughout the 8 week period of study participation||||serious adverse event|||Number
1243747|NCT00554372|Primary|Proportion of Subjects Achieving Disease Control (Non-progressive Disease) at 8 Weeks After Initiation of Treatment|Proportion of subjects achieving disease control at 8 weeks based on a modified Response Evaluation Criteria in Solid Tumors v1.0 (mRECIST). Per mRECIST for target lesions as assessed by dynamic contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of all tumor(s); Partial Response (PR), >=30% decrease in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any increase of >= 20% in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum. Disease Control (DC) = CR or PR or SD. For mRECIST criteria, new tumor(s) that developed within the liver were measured (a new tumor was defined as a malignant tumor not present at baseline, was ≥ 1 cm in LD had typical hypervascular features of HCC). Their maximum diameter(s) were included in the sum of the maximum diameter; new tumors were not considered evidence for progression.|Initial progression status and response assessment at 8 weeks from first dose|Patients having evaluable radiographic imaging, 2 patients in each arm were excluded due to unevaluable images, 1 patient in the low dose arm was excluded due to a protocol deviation|||Proportion of evaluable participants||95% Confidence Interval|Number
1243748|NCT00554294|Secondary|Parameters of Process Evaluation (Acceptance, Feasibility)||1,5 years|||||||
1243749|NCT00554294|Secondary|Water Flow of the Water Dispensers||one school year|||||||
1243750|NCT00554294|Secondary|Physical Activity and Inactivity||one school year|||||||
1243751|NCT00554294|Secondary|Intake of Drinks||one school year|||||||
1243752|NCT00554294|Primary|Overweight|Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)|one school year||||participants|||Number
1243753|NCT00554229|Secondary|Pharmacokinetic Characteristics of ZD4054||PK samples were performed at randomisation, Week 4, Week 8 and Week 12|||||||
1243754|NCT00554229|Secondary|Time to Initiation of Chemotherapy|Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method|Patients were assessed every 12 weeks||||Months||Inter-Quartile Range|Median
1243755|NCT00554229|Secondary|Time to Pain Progression|Median time (in months) from randomisation to first assessment of an increased pain event, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.|Patients were assessed every 12 weeks||||Months||Inter-Quartile Range|Median
1243756|NCT00554229|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Median time (in months) from randomisation to first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.|Patients were assessed every 12 weeks||||Months||Inter-Quartile Range|Median
1243757|NCT00554229|Secondary|Health Related Quality of Life|Median time (in months) from randomisation until deterioration of Health related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.|Patients were assessed at every visit||||Months||Inter-Quartile Range|Median
1243758|NCT00554229|Secondary|Bone Metastases Formation|Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method|Patients were assessed every 12 weeks||||Months||Inter-Quartile Range|Median
1243759|NCT00554229|Secondary|Incidence of Skeletal Related Events|Median time (in months) from randomisation until occurrence of a skeletal related event, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression, using the Kaplan-Meier method.|From date of randomization until occurrence of a skeletal related event, assessed up to 31 months||||Months||Inter-Quartile Range|Median
1243760|NCT00554229|Secondary|Time to Use of Opiates|Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method|From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months||||Months||Inter-Quartile Range|Median
1243761|NCT00554229|Secondary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline, using the Kaplan-Meier method|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months||||Months||Inter-Quartile Range|Median
1243762|NCT00554229|Primary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method|From date of randomization until date of death, assessed up to 32 months||||months||Full Range|Median
1243763|NCT00554216|Primary|Percentage of Subjects With at Least 5% Weight Loss at Week 56||baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)|||percentage of participants|||Number
1243764|NCT00554216|Primary|Percent Weight Loss From Baseline to Week 56||baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
1243765|NCT00554190|Primary|Number of Participants With Solicited and Recorded Adverse Events|All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized.|Post-operative through 60 days|There were 19 participants who completed the 60 day follow up visits for analysis.|||Participants|||Number
1243766|NCT00554190|Primary|Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale|Synechia (adhesion) scale range of 0 = No visible synechia to 3 = Complete scarring between the middle turbinate and lateral nasal wall was used in the assessment.|Post-operative through 60 days|There were 19 participants that completed the final follow-up visit at 60 days.|||Participants|||Number
1243770|NCT00554099|Secondary|Change in GSS From Baseline to Week 52 - ITT Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|Baseline to Week 52|ITT Population|||Scores on a Scale||Standard Error|Mean
1243771|NCT00554099|Secondary|Change in GSS From Baseline to Week 12 - ITT Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|Baseline to Week 12|ITT Population|||Scores on a Scale||Standard Error|Mean
1243772|NCT00554099|Secondary|Percentage of Responders at Week 52 - ITT Population|Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|52 Weeks|ITT Population|||Percentage of Participants|||Number
1243773|NCT00554099|Secondary|Percentage of Responders at Week 12 - ITT Population|Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|12 Weeks|ITT Population|||Percentage of Participants|||Number
1243774|NCT00554099|Primary|Global Symptom Score (GSS) at Week 12, Primary Efficacy Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|12 Weeks|Primary Efficacy Population - Subset of ITT population including only patients with GSS value at Week 12 and baseline GSS of at least 12.|||Scores on a Scale||Standard Error|Mean
1243775|NCT00553969|Primary|Change in Disease Score (DS) Among the Treatment Groups|Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble.|Baseline and nine months|Calculation for change is the value at the later time point minus the value at the earlier time point.|||Overall Rasmussen Disease Score Change||Standard Deviation|Mean
1243776|NCT00553839|Primary|Residual Error|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Residual Error was analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease|||proportional %||95% Confidence Interval|Median
1243777|NCT00553839|Primary|Central and Peripheral Volume of Distribution|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Central and Peripheral Volume of Distribution were analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease|||L/70kg||95% Confidence Interval|Median
1243778|NCT00553839|Primary|Total Clearance and Intercompartmental Clearance|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease|||L/h/70kg||95% Confidence Interval|Median
1243779|NCT00553787|Primary|Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF||Baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)|||percentage of participants|||Number
1243780|NCT00553787|Primary|Percent Weight Loss From Baseline to Week 56||Baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
1243781|NCT00553735|Secondary|Schirmer With Anesthesia||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
1243782|NCT00553735|Secondary|Schirmer Without Anesthesia||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
1243783|NCT00553735|Secondary|Tear Break-up Time (TBUT)||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
1243784|NCT00553735|Secondary|Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
1243785|NCT00553735|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.|18 Months|All patients enrolled in the study were analyzed.|||participants|||Number
1243786|NCT00553735|Primary|Conjunctival Staining Score||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
1243788|NCT00553696|Secondary|Time to Progression (TTP)|Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).|||Months||95% Confidence Interval|Median
1243789|NCT00553696|Secondary|Progression-Free Survival (PFS)|Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).|||Months||95% Confidence Interval|Median
1243790|NCT00553696|Secondary|Duration of Response (DR)|Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).|Baseline up to 739 days|A subgroup of participants with an objective tumor response among Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib)|||Months||95% Confidence Interval|Median
1243791|NCT00553696|Secondary|Number of Participants With Clinical Benefit Response (CBR)|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).|||participants|||Number
1243792|NCT00553696|Secondary|Number of Participants With Objective Response|Number of participants with objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib)|||participants|||Number
1243793|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||ng*h/mL||Standard Deviation|Mean
1243794|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum||Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||hrs||Full Range|Median
1243795|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum||Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1243796|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||ng*h/mL||Standard Deviation|Mean
1243797|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU||Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||hrs||Full Range|Median
1243798|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU||Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1243799|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||ng*h/mL||Standard Deviation|Mean
1243800|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)||Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||hrs||Full Range|Median
1243801|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)||Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1243802|NCT00553696|Primary|Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)|A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).|Cycle 1 (Baseline to Week 4)|DLT Evaluation Set consisted of participants who were initially enrolled for the determination of maximam tolerated dose (MTD), and either 'experienced DLT' or 'received all of the Day 1 chemotherapy, received at least 80% of their sunitinib doses, and at least 80% of S-1 doses'.|||participants|||Number
1243804|NCT00553644|Secondary|Time to Progression|Time to progression (TTP) is defined as the time from study entry until progression or death due to any cause. The median TTP with 95% CI was estimated using the Kaplan-Meier method.|Assessed up to 6 years||||years||95% Confidence Interval|Median
1243805|NCT00553644|Secondary|Incidence of Adverse Events|Number of participants who experienced a maximum grade 3, 4 or 5 adverse event. The grading scales found in the revised NCI CTCAE version 4.0 was utilized for adverse event reporting|Duration of Treatment (up to 6 years)||||participants|||Number
1243806|NCT00553644|Primary|Number of Participants With an Overall Response Defined as Complete Response and Partial Response|"Response is assessed by investigator according to International Working Group (IWG) criteria.~A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease."|Duration of treatment (assessed up to 6 years)||||participants|||Number
1243807|NCT00553631|Secondary|Time to Response- Comparison of GA-GCB and Imiglucerase on the Earliest Time to Respond as Assessed Via Hemoglobin Concentration|Time to response was defined as a ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline. Units (%) correlates to the percentage of participants who had a change of ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline during their participation in the study.|Response rate at Month 9 compared to Baseline|ITT population|||Percentage of participants|||Number
1243808|NCT00553631|Secondary|Number of Participants Who Developed Antibody for Each Treatment Group.|Measure type is actual number of participants who developed antibodies to treatment; GA-GCB or imiglucerase. Antibody detection was based upon serum samples collected at various time points throughout the study. Serum samples were screened using an enzyme-linked immunosorbent assay (ELISA) and positive antibody confirmation was determined using a radioimmunoprecipitation assay (RIP); positive samples were also tested for enzyme neutralizing activity. Participant samples were compared to internal assay controls (positive/negative), positive samples were determined based upon individual assay criteria.|Baseline to Month 9|Safety population comprised of all randomized participants who received at least 1 full or partial dose of study drug.|||participants|||Number
1243809|NCT00553631|Secondary|Change From Baseline to Month 9 in Plasma Chemokine (C-C Motif) Ligand 18 (CCL18) for Each Treatment Group.|Values shown are observed change from Baseline to Month 9.|Baseline to Month 9|ITT population.|||nanogram per milliliter (ng/mL)||Standard Error|Mean
1243810|NCT00553631|Secondary|Change From Baseline to Month 9 in Plasma Chitotriosidase for Each Treatment Group.|Values shown are observed change from Baseline to Month 9. Units of measure is defined as nanomole per milliliter per hour.|Baseline to Month 9.|ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Chitotriosidase levels were measured in 10 participants in the velaglucerase alfa group and 11 participants in the imiglucerase group.|||nanomole/milliliter/hour (nmol/mL/h)||Standard Error|Mean
1243811|NCT00553631|Secondary|Change From Baseline to Month 9 in Normalized Spleen Volume (Percent (%) Body Weight) for Each Treatment Group.|Values shown are observed change from Baseline to month 9. Measured by Magnetic resonance imaging (MRI). Spleen volume was normalized for percent (%) of body weight for each treatment arm. Spleen size relative to body weight=(Spleen volume [cc]/Body weight [kg])*100.|Baseline to Month 9|ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Ten participants in each treatment group underwent splenectomy, and therefore, were excluded from the analysis.|||cm^3||Standard Error|Mean
1243812|NCT00553631|Secondary|Change From Baseline to Month 9 in Normalized Liver Volume (Percent (%) Body Weight) for Each Treatment Group.|Values shown are observed change from Baseline to Month 9. Measured by Magnetic resonance imaging (MRI). Liver volume has been normalized for percent (%) body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cubic centimeter (cc)]/Body weight [kg]*1000.|Baseline to Month 9|ITT population.|||cubic centimeter (cm^3)||Standard Error|Mean
1243813|NCT00553631|Secondary|Change From Baseline to Month 9 in Platelet Counts for Each Treatment Group.|Values shown are observed change from Baseline to Month 9.|Baseline to Month 9|ITT population.|||10^9 per liter (10^9/L)||Standard Error|Mean
1243814|NCT00553631|Primary|Mean Change From Baseline to Month 9 in Hemoglobin (Hgb) Concentration for Each Treatment Group.||Baseline to Month 9|Intent-to-treat (ITT) population comprised of all randomized participants who received at least 1 full or partial dose of study drug.|||gram per deciliter (g/dl)||Standard Error|Mean
1243815|NCT00553605|Secondary|Number of Participants With Use of Rescue Medication (RM)|Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.|Up to Minute 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.|||participants|||Number
1243816|NCT00553605|Secondary|Physician’s Global Evaluation of Study Medication|Physicians’ response to the question “How would you rate the study medication the patient received for pain?” on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1243817|NCT00553605|Secondary|Patient’s Global Evaluation of Study Medication|"Participants' response to the question How would you rate the study medication you received for pain?” on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated."|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1243818|NCT00553605|Secondary|Number of Participants With Response in Pain Intensity|PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm.|Minute 30|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1243819|NCT00553605|Secondary|Number of Participants With Pain Relief (PR)|PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||participants|||Number
1243820|NCT00553605|Secondary|Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)|TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|Baseline through Minute 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1243821|NCT00553605|Secondary|Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120|PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain.|Baseline, Minute 15, 30, 45, 60, 90, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘n’ signifies participants who were evaluable at specific time points for each treatment arm respectively.|||mm||Standard Deviation|Mean
1243822|NCT00553605|Secondary|Time-specific Pain Intensity (PI) VAS Score|PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain.|Baseline, Minute 15, 30, 45, 60, 90, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||mm||Standard Deviation|Mean
1243823|NCT00553605|Secondary|Mean Pain Intensity Difference at 120 Min (mPID120min)|mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.|Minute 120|Modified intent- to-treat (mITT) included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.|||mm||Standard Error|Least Squares Mean
1243824|NCT00553605|Primary|Mean Pain Intensity Difference at 30 Minutes (mPID30min)|mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.|Minute 30|Per-protocol (PP): all randomized participants who received at least 1 dose of study drug; had 1 post-baseline pain assessment; no major protocol violations; received appropriate dose of study drug; had valid baseline, 15 and 30 min VAS pain assessments; did not take rescue medications for 30 min; had confirmed diagnosis of nephrolithiasis.|||mm||Standard Error|Least Squares Mean
1243825|NCT00553514|Secondary|Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm||Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Follicles||Standard Deviation|Mean
1243826|NCT00553514|Secondary|Cumulative Dose of Supplemental Follitropin Alfa Administered||Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||IU||Standard Deviation|Mean
1243827|NCT00553514|Secondary|Duration of Supplemental Follitropin Alfa Treatment||Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
1243828|NCT00553514|Secondary|Duration of Ovarian Stimulation|Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).|Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
1243829|NCT00553514|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Percentage of participants|||Number
1243846|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243830|NCT00553514|Primary|Percentage of Participants With Ovulation|Ovulation was defined as a mid-luteal phase progesterone (P4) level >= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter [ng/mL]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.|Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])|Per Protocol (PP) population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Percentage of participants|||Number
1243831|NCT00553501|Post-Hoc|3-Year Overall Survival|Percentage of participants who were alive at 3 years. The 3 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|3 years||||percentage of participants||95% Confidence Interval|Number
1243832|NCT00553501|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||years||95% Confidence Interval|Median
1243833|NCT00553501|Primary|Number of Participants With Overall Response|"Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.~CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions"|12 months||||participants|||Number
1243834|NCT00553475|Primary|Change From Baseline at Week 13 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.~Change from baseline: Score at Week 13 minus score at baseline"|From baseline to Week 13|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243835|NCT00553475|Secondary|Patient Global Impression of Change|The Patient Global Impression of Change is a patient-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 13 or up to discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Deviation|Mean
1243836|NCT00553475|Secondary|Clinical Global Impression of Change|Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 13 or up to discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Deviation|Mean
1243837|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243838|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243839|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243840|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243841|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243842|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243843|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243844|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243845|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||mm||Standard Error|Least Squares Mean
1243847|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243848|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243849|NCT00553475|Secondary|Change From Baseline in Mean Sleep Interference Scores|The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243850|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243851|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243852|NCT00553475|Primary|Change From Baseline at Week 12 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.~Change from baseline: Score at Week 12 minus score at baseline"|From baseline to Week 12|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243853|NCT00553475|Primary|Change From Baseline at Week 11 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.~Change from baseline: Score at Week 11 minus score at baseline"|From baseline to Week 11|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243854|NCT00553475|Primary|Change From Baseline at Week 10 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.~Change from baseline: Score at Week 10 minus score at baseline"|From baseline to Week 10|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243855|NCT00553475|Primary|Change From Baseline at Week 9 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.~Change from baseline: Score at Week 9 minus score at baseline"|From baseline to Week 9|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243856|NCT00553475|Primary|Change From Baseline at Week 8 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.~Change from baseline: Score at Week 8 minus score at baseline"|From baseline to Week 8|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243857|NCT00553475|Primary|Change From Baseline at Week 7 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.~Change from baseline: Score at Week 7 minus score at baseline"|From baseline to Week 7|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243858|NCT00553475|Primary|Change From Baseline at Week 6 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.~Change from baseline: Score at Week 6 minus score at baseline"|From baseline to Week 6|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243859|NCT00553475|Primary|Change From Baseline at Week 5 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.~Change from baseline: Score at Week 5 minus score at baseline"|From baseline to Week 5|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243860|NCT00553475|Primary|Change From Baseline at Week 4 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.~Change from baseline: Score at Week 4 minus score at baseline"|From baseline to Week 4|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243861|NCT00553475|Primary|Change From Baseline at Week 3 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.~Change from baseline: Score at Week 3 minus score at baseline"|From baseline to Week 3|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243862|NCT00553475|Primary|Change From Baseline at Week 2 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.~Change from baseline: Score at Week 2 minus score at baseline"|From baseline to Week 2|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1248049|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 64 weeks||||liters||Standard Error|Least Squares Mean
1243863|NCT00553475|Primary|Change From Baseline at Week 1 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.~Change from baseline: Score at Week 1 minus score at baseline"|From baseline to Week 1|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
1243864|NCT00553475|Primary|Number of Responders|A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||participants|||Number
1243865|NCT00553475|Primary|Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations|Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243866|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243867|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243868|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243869|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243870|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243871|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243872|NCT00553475|Primary|Change From Baseline to Study Endpoint in Mean Weekly Pain Scores|Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1243873|NCT00553462|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)||||months||95% Confidence Interval|Median
1243874|NCT00553462|Secondary|Response Rate|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Response rate is reported as the percentage of participants who achieved each response."|Duration of study (up to 2 years)||||percentage of participants|||Number
1243875|NCT00553462|Primary|Overall Survival at 12 Months|Percentage of participants who were alive at 12 months.|At 12 months||||percentage of participants||95% Confidence Interval|Number
1243876|NCT00553436|Primary|Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)|Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.|At The Time of Surgery|All enrolled subjects were analyzed|||participants|||Number
1243877|NCT00553436|Secondary|Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition||3 month follow-up|All enrolled subjects were analyzed|||Participants|||Number
1243878|NCT00553436|Secondary|Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.|The total number of participants with successful deployments of tissue anchors and associated knotting elements for tissue closure post-Endoscopic Mucosal Resection (EMR) tissue apposition and achieving defect closure.|3 month follow-up||||participants|||Number
1246833|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type|Other skin lesions included xerosis and paronychia.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||percentage of participants|||Number
1243879|NCT00553358|Secondary|Number of Circulating Tumor Cells (CTC) in the Bloodstream|Circulating tumor cells (CTCs) are cells that have detached from a primary tumor and circulate in the bloodstream. In the adjuvant phase, after surgery all participants received 3 courses of adjuvant 5-fluorouracil, epirubicin and cyclophosphamide, followed by lapatinib 1500 mg or trastuzumab 2 mg/kg or lapatinib 1000/750 mg plus trastuzumab 2 mg/kg given prior to surgery in the neoadjuvant setting for an additional 34 weeks. Data for this outcome measure cannot be presented at this time as they have yet to be evaluated and reviewed.|Baseline, Week 2 of neo-adjuvant phase (Weeks 1-34), at surgery (Weeks 20 to 22), Week 10 of adjuvant phase, 6 months after completion of adjuvant treatment, and at recurrence||2021-08-31|08/2021||||
1243880|NCT00553358|Secondary|Number of Participants With the Indicated Biomarker Expression|Biomarker levels (Ki67, p27, Cyclin-D1, ErbB1, ErbB2, ErbB3, pErbB1, pErbB2, Akt and pAkt, S6 and pS6, MAPK and pMAPK, c-myc, IGFR1, p95HER2, PTEN, ER (alpha, beta), PgR,CD34, terminal deoxynucleotidyl transferase biotin-dUTP nick and labelling technique [TUNEL] and topoisomerase II) were assessed in participants. Blood and tumor tissue samples were collected at Baseline and at Weeks 2 and 20-22; however, data for this outcome measure cannot be presented at this time as they have yet to be evaluated and reviewed.|Baseline, Week 2, and at surgery (Weeks 20 to 22)||2021-08-31|08/2021||||
1243881|NCT00553358|Secondary|Number of Participants With Metabolic Response of Complete Response (mCR), Partial Response (mPR), or Stable Disease (mSD) as Determined by Positron Emission Tomography/Computed Tomography (PET/CT)|European Organisation for Research and Treatment of Cancer recommendations were used to define metabolic response. mCR, complete metabolic response: complete resolution of fludeoxyglucose uptake within tumor, indistinguishable from surrounding normal tissue. mPR, partial metabolic response: reduction of more than 25% of maximum tumor standard uptake value (SUV). mSD, stable metabolic disease: increase of <25% in tumor SUV or decrease of >20% in tumor SUV. mPD, progressive metabolic disease: increase of >25% in tumor SUV or >20% in the extent (longest dimension) or appearance of new metastases.|Baseline, Week 2, and Week 6||2021-08-31|08/2021||||
1243882|NCT00553358|Secondary|Disease-free Survival (DFS)|DFS was defined as the time from surgery to the first date of breast cancer relapse, second primary tumor (including contralateral breast cancer), or death without documented prior relapse. Data will be reported when they are mature and available, likely when a median of 3 years follow up has been reached.|Following surgery, every 12 months until Year 10||2019-01-31|01/2019||||
1243883|NCT00553358|Secondary|Overall Survival|Overall survival was defined as the period from surgery until death (from any cause). Data will be reported when they are mature and available; OS is assessed annually for up to 10 years after the randomization of the last participant into the study.|Following surgery, every 12 months until Year 10||2020-01-31|01/2020||||
1243884|NCT00553358|Secondary|Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or Trastuzumab|Participants with progressive disease at 4 week assessment that were permitted to commence treatment with paclitaxel.|Week 6|ITT Population. Participants who did not start any treatment were excluded from analysis.|||participants|||Number
1243885|NCT00553358|Secondary|Estimate of Treatment Contrast for Change From Baseline in Tumor Size at Week 6 and at Surgery|Estimate of treatment contrast is defined as the estimate of the difference between treatment groups in the change from baseline in tumor size. Change from baseline in tumor size was defined as tumor size at Week 6/ surgery (Weeks 20 to 22) minus tumor size at baseline. The difference in treatment arms was estimated for Lapatinib 1500 mg versus Trastuzumab 2 mg/kg and for Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg versus Trastuzumab 2 mg/kg.|Week 6 and surgery (Weeks 20 to 22)|ITT Population|||millimeters||Standard Deviation|Mean
1243886|NCT00553358|Secondary|Number of Participants With Actual Indicated Surgery|Participants were assessed for the type of surgery they underwent for breast cancer. Non-conservative surgery is defined as a radical or modified radical mastectomy. Conservative surgery is comprised of a lumpectomy, a quadrantectomy/segmentectomy, or a partial mastectomy. Participants who were not assessed as being candidates for non-conservative or conservative surgery were classified as non-operable.|At surgery (Weeks 20 to 22)|ITT Population|||participants|||Number
1243887|NCT00553358|Secondary|Number of Participants With Negative Lymph Nodes at the Time of Surgery|Participants were assessed for node-negative lymph nodes at the time of surgery. As per the pathological TNM (Tumor, Node, Metastases) classification (pTNM) of malignant tumors: pN, absence or presence and extent of regional lymph node metastasis. Node-negative (pN0) participants had no regional lymph node metastasis. Although not assessed in this measure, pT is the extent of primary tumor, and pM is the absence or presence of distant metastasis.|Time of surgery (Weeks 20 to 22)|ITT Population. Participants with a lymph node status of pNX (i.e., regional lymph nodes cannot be assessed) were omitted from the analysis of node-negative participants.|||participants|||Number
1243888|NCT00553358|Secondary|Number of Participants With Overall Response at the Time of Surgery|The number of participants with overall response (complete response and/or partial response) was evaluated using WHO criteria by clinical examination and mammography and breast echography with bi-dimensional measurements at the time of surgery (Weeks 20 to 22). As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.|Time of surgery (Weeks 20 to 22)|ITT Population|||participants|||Number
1243889|NCT00553358|Secondary|Number of Participants With Overall Response at Week 6|The number of participants with overall response (complete response and/or partial response) was evaluated using World Health Organization (WHO) criteria by clinical examination and by mammography and breast echography with bi-dimensional measurements at Week 6. As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.|Week 6|ITT Population|||participants|||Number
1243909|NCT00553267|Secondary|Trough Seated SBP Control|The number of patients who reach the target SBP of <140mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
1243890|NCT00553358|Primary|Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery|Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status.|Weeks 20 to 22|Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication|||participants|||Number
1243891|NCT00553332|Secondary|Protein Levels of RAS/RAF/MEK/ERK Signaling Pathway Activation|Measure the proteins levels of RAS/RAF/MEK/ERK signaling pathway activation to AZD6244|At baseline|Only 27 patients had pAKT and pERK performed due to 2 samples not available for analysis|||mg/ml||Standard Deviation|Mean
1243892|NCT00553332|Secondary|RAS/RAF/MEK/ERK Signaling Pathway Activation||At baseline|Data was not collected and analyzed||||||
1243893|NCT00553332|Secondary|Overall Survival||Up to 12 months|Kaplan-Meier|||months||95% Confidence Interval|Median
1243894|NCT00553332|Secondary|Median Progression Free Survival for Patients|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 6 months||||months||95% Confidence Interval|Median
1243895|NCT00553332|Secondary|Toxicity Profile of AZD6244|Toxicitity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0|From the time of first treatment with AZD6244, assessed up to 4 weeks||||percent of patients|||Number
1243896|NCT00553332|Primary|Objective Response Rate (CR and PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 8 weeks||||patients|||Number
1243897|NCT00553319|Primary|ADHD Symptoms Based on ADHD Rating Scale|The proportion of subjects exhibiting >30% reduction of AISRS score at last enrollment week compared to week 0|measured once per week for 14 weeks or length of study participation||||participants|||Number
1243898|NCT00553319|Primary|Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use|Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE <300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing.|weekly for 14 weeks of trial or for length of participation||||percentage of participants|||Number
1243899|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||score on scale||Standard Deviation|Mean
1243900|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||mm||Standard Deviation|Mean
1243901|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||score on scale||Standard Deviation|Mean
1243902|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||score on scale||Standard Deviation|Mean
1243903|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||score on scale||Standard Deviation|Mean
1243904|NCT00553280|Primary|Summary of Adverse Events|Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.|53 weeks|Safety analysis set: all participants who had received at least one dose of the study drug.|||participants|||Number
1243905|NCT00553267|Secondary|Peripheral Oedema Incidence Rate|The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)|During randomised treatment period||||Number of cases/100 patient-years|||Number
1243906|NCT00553267|Secondary|Oedema Incidence Rate|The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)|During randomised treatment period|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Number of patients/100 patient-years|||Number
1243907|NCT00553267|Secondary|Trough Seated BP Normality Classes|The number of patients who reach predefined BP categories|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
1243908|NCT00553267|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
1243910|NCT00553267|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
1243911|NCT00553267|Secondary|Trough Seated Diastolic Blood Pressure <80 mmHg|The number of patients who reach the target DBP of <80mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
1243912|NCT00553267|Secondary|Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)|The number of patients who reach the target DBP of <90mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
1243913|NCT00553267|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP|Baseline and end of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1243914|NCT00553267|Primary|Change From Baseline in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP|Baseline and end of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1243915|NCT00553202|Other Pre-specified|Time to the Donor-specific NK-cell Receptor Expression|The presence of donor cells is demonstrated by the detection of informative variable-number tandem-repeat polymorphisms or by fluorescent in situ hybridization with a Y-chromosome-specific probe in cases of sex-mismatched transplants. Independent variables that will be examined include donor-recipient KIR mismatch, taking into consideration the interactions with donor-recipient human leukocyte antigen (HLA) compatibility, and the numbers of CD34+ cells and CD3+ cells in the graft.|Up to 42 days after SCT|||||||
1243916|NCT00553202|Other Pre-specified|Acute and Chronic Graft-versus-host Disease|Acute and chronic GVHD will be summarized.|Up to 5 years|||||||
1243917|NCT00553202|Other Pre-specified|Disease-free Survival|The cumulative incidence of relapse or death after SCT will be calculated by considering relapse and death due to other causes as competing events.|From the date of SCT to the date of relapse, the date of death, or the date of last follow-up, whichever occurs first|||||||
1243918|NCT00553202|Primary|Cumulative Incidence of NK Cell Reconstitution|Cumulative incidence of successful reconstitution to donor level is calculated.|At 5 years from HSCT date|Patients without completion of planned therapy (n=68) or without NK cell status (n=38) are excluded from analyses of TExp|||Percentage of participants||95% Confidence Interval|Number
1243919|NCT00553202|Primary|Overall Survival (OS)|OS - Time from HSCT until death|At 5 years from HSCT date|Patients without completion of planned therapy (n=68) are excluded from analyses of OS|||Percentage of participants||95% Confidence Interval|Number
1243920|NCT00553150|Secondary|Overall Survival Time|Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.|Up to 15 years||||months||95% Confidence Interval|Median
1243921|NCT00553150|Secondary|Progression-free-survival at 6 Months (Phase II)|Progression-free-survival at 6 months: is the proportion of patients alive and progression-free at 6 months after start of regimen. This proportion will be estimated using the binomial point estimator and the binomial 95% confidence interval estimated. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|at 6 months||||proportion of participants||95% Confidence Interval|Number
1243922|NCT00553150|Secondary|Time to Progression (Phase II)|Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy. Patients who experience major treatment violations will be censored for progression on the date of treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|Up to 5 years||||months||95% Confidence Interval|Median
1243923|NCT00553150|Secondary|Response Rate, as Measured in Patients Receiving FLT-PET Imaging (Phase II)|The response rate is defined as the percentage of patients receiving F-fluorothymidine positron emission tomography (FLT-PET) imaging whose cancer shrinks or disappears after treatment. A reduction in standardized uptake value (SUV) of 30% or greater in the T1-post-gadolinium scan volume of interest (T1-gad VOI) or the total tumor VOI will be considered a responsive tumor.|Up to 5 years|Of the 11 patients with measurable residual disease and pre-everolimus FLT-PET imaging, 2 did not have a second FLT-PET scan performed due to technical difficulties with FLT production, leaving 9 patients who could be assessed for changes in FLT uptake.|||percentage of participants||95% Confidence Interval|Number
1243924|NCT00553150|Primary|Overall Survival at 12 Months (Phase II)|"The primary endpoint is overall survival at 12 months (OS12) after entry into this study. The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. A patient who is evaluable and survive more than 12 months (i.e. 365 days or more) after start of therapy will be classified as a “success”. Patients who die within 12 months after start of therapy will be considered to have failed”."|at 12 months||||proportion of participants||95% Confidence Interval|Number
1243957|NCT00552513|Secondary|Stroke at 30 Days and 180 Days||180 days|||||||
1243925|NCT00553150|Primary|Maximum Tolerated Dose (MTD) of Everolimus (RAD001) in Combination With Temozolomide (TMZ) and 3D-conformal Radiotherapy (RT) or Intensity-modulated Radiotherapy (IMRT) Followed by Adjuvant TMZ With or Without RAD001 (Phase I)|Patients were assessed during RT for dose-limiting toxicities (DLT), which were defined as failure to deliver greater than 75% of the planned doses of TMZ or RAD001 during RT, interruption of RT for more than 5 days because of toxicity, or the following: >= Grade 3 diarrhea or skin rash; >= Grade 4 neutropenia, leukopenia, or thrombocytopenia; >= Grade 4 hypertriglyceridemia, hypercholesterolemia, or hyperglycemia despite optimal medial management, other >= 3 non-hematologic events; or >= Grade 4 radiation dermatitis. Maximum tolerated dose (MTD) was defined a priori as the highest dose level at which 0 or 1 of 6 patients developed DLTs. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.|Up to 49 days|Eighteen patients were enrolled in Phase I of the study to determine the maximum tolerated dose (MTD). The dosage of RAD001 was escalated in cohorts of 6 patients.|||participants who developed DLTs|||Number
1243926|NCT00553098|Secondary|Number of Patients Diagnosed With Chronic GVHD|Number of patients diagnosed with chronic GVHD within 1 year post transplant|1 year|Excludes 6 patients who expired prior to Day 100|||Participants|||Count of Participants
1243927|NCT00553098|Secondary|Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD|Number of patients diagnosed with overall Grade III or Grade IV Acute GVHD by Day 100 post transplant|Day 100|Excludes 10 patients who were not diagnosed with acute GVHD|||Participants|||Count of Participants
1243928|NCT00553098|Secondary|Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD|Number of patients diagnosed with overall grade I or grade II acute GVHD by Day 100 post transplant|Day 100|Excludes 10 patients who were not diagnosed with acute GVHD|||Participants|||Count of Participants
1243929|NCT00553098|Secondary|Number of Patients Diagnosed With Acute GVHD|Number of patients diagnosed with acute GVHD by Day 100 post transplant|Day 100||||Participants|||Count of Participants
1243930|NCT00553098|Secondary|Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant|Number of patients who experienced a clinical significant infection, requiring treatment, within 100 days post transplant.|100 days||||Participants|||Count of Participants
1243931|NCT00553098|Secondary|Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant|Number of Patients Who Achieve Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant|1 year|Excludes 9 patients who expired prior to 1 year time point|||Participants|||Count of Participants
1243932|NCT00553098|Secondary|Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant|Number of patients who achieve greater than 50% CD33+ donor chimerisms at 1 year post transplant.|1 year|Excludes 9 patients who expired prior to 1 year time point|||Participants|||Count of Participants
1243933|NCT00553098|Secondary|Disease Response by 1 Year Post Transplant|Number of patients at 1 year with disease response (defined as no clinical evidence of active disease and/or sufficient level of donor chimerisms to prevent disease recurrence)|1 year|Excludes 9 patients who expired prior to 1 year time point.|||Participants|||Count of Participants
1243934|NCT00553098|Secondary|Immune Reconstitution by 1 Year Post Transplant|Number of patients with normal range CD3 at 1 year post transplant|1 year|Excludes 16 patients: 13 patients who did not achieve 1 year time point (9 expired, 4 went to second transplant) and 3 patients for whom no data was sent at 1 year from external site|||Participants|||Count of Participants
1243935|NCT00553098|Secondary|Overall Survival|Number of patients alive at 1 year|1 year|Excludes 3 patients with graft rejection and second transplant prior to 1 year.|||Participants|||Count of Participants
1243936|NCT00553098|Primary|Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism|The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence will be used to evaluate the probability of chimerism.|At 1 year post transplant|Excludes 9 patients who expired prior to 1 year|||Participants|||Count of Participants
1243937|NCT00552812|Secondary|Systolic Blood Pressure, Difference Between Upper and Lower Extremities|Measurement of difference between upper and lower extremities by noninvasive, automated measurement of four quadrant Systolic Blood Pressure. Comparison between baseline and 12 month follow up.|Baseline and 12 months|Comparison between baseline(n=105) and 12 month follow up (n=92)|||mmHg||Standard Deviation|Mean
1243938|NCT00552812|Secondary|Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement|Noninvasive Blood pressure is assessed at baseline and 12 months. The number of patients with a Systolic Blood Pressure > 95th Percentile for Age and Gender is recorded at Baseline (n=105) and compared to 12 month follow up (n=92).|Baseline and 12 months|Study patients compared at baseline and within the 12 month follow up window: Baseline (n=105) compared to 12 month follow up (n=92)|||percentage of participants|||Number
1243939|NCT00552812|Primary|Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months|Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)|12 months||||mmHg||Standard Deviation|Mean
1243958|NCT00552513|Secondary|Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days||180 days||||Eparticipants|||Number
1243959|NCT00552513|Secondary|First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia||180 days||||participants|||Number
1243960|NCT00552513|Primary|Composite of Death, Myocardial (re-) Infarction, or Stroke||180 days|All patients were included in the final intention-to-treat analysis. Event rates in the two groups were estimated with the use of the Kaplan–Meier method. The hazard ratio and two-sided 95% confidence intervals were calculated with the use of a Cox proportional-hazards model.|||participants|||Number
1243961|NCT00552448|Secondary|Number of Participants With Chest Discomfort||During PICU admission||||participants|||Number
1243940|NCT00552786|Secondary|Temporary Threshold Changes Measurement by Distortion Product Otoacoustic Emissions (DPOAE) (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)|Distortion product otoacoustic emissions (DPOAE) is an objective measure to assess the cochlear changes. DPOAE response threshold at high frequency (HF) was defined as the average of response levels (dB SPL) at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by DPOAE were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of DPOAE temporary threshold change was calculated by subtracting the pre-shift DPOAE response threshold from the post-shift DPOAE response threshold at each frequency.|A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift|Intent to treat analysis including only participants who had all 4 post-baseline assessments (measurements at beginning of 1st and 2nd intervention periods and end of 1st and 2nd intervention periods).|||decibels (dB SPL)||Standard Deviation|Mean
1243941|NCT00552786|Primary|Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)|The hearing threshold level (HL) at high frequency (HF) by pure-tone audiometry (PTA) was defined as the average of HLs at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by PTA were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of temporary threshold change was calculated by subtracting the pre-shift hearing threshold from the post-shift hearing threshold at each frequency.|A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift|Intent to treat analysis including only participants who had at least one post-baseline assessment.|||decibels||Standard Deviation|Mean
1243942|NCT00552760|Secondary|Cumulative Proportion of Participants in Each Arm Surviving Without Relapse|Survival analysis techniques, including Kaplan Meier curves, were used to evaluate group differences in time to relapse. Relapse was defined as a medication initiation or change for manic/depressed/mixed symptoms, a hospitalization for manic/depressed/mixed symptoms, MADRS score >= 16, YMRS score > 14, and suicide risk or imminent risk of suicide. Time to relapse was measured discretely in terms of the number of assessment visits until discontinued from the study.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures.|||Cumulative proportion of participants|||Number
1243943|NCT00552760|Secondary|Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score|3-part (mania, depression, overall bipolar illness), physician-administered scale used to assess global illness severity; used to measure change. Each part is rated from 1-7, higher scores represent more severe mental illness. Only overall bipolar rating was used.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures|||units on scale||Standard Error|Mean
1243944|NCT00552760|Secondary|Young Mania Rating Scale (YMRS) Total Score|11-item standardized, well-validated scale used to measure manic symptoms; sensitive to treatment effects in manic patients. Scores range from 0-60, higher scores represent more severe manic symptoms.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures|||units on scale||Standard Error|Mean
1243945|NCT00552760|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|10-item, standardized, well-validated scale used to measure severity of depressive symptoms; sensitive to treatment effects in depressed outpatients. Scores range from 0-60, higher scores represent more severe depressive symptoms.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures|||units on scale||Standard Error|Mean
1243946|NCT00552760|Primary|Pittsburgh Sleep Quality Index (PSQI) Global Score|Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0-21, higher scores represent more significant sleep disturbance.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures.|||units on scale||Standard Error|Mean
1243947|NCT00552695|Primary|Pain on Visual Analog Scale (VAS)|Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).|0 MINUTES||||mm||Inter-Quartile Range|Median
1243948|NCT00552695|Secondary|Success of Intravenous (IV) Insertion|Percentage of patients in whom intravenous catheter was inserted successfully|After first attempt of catheter insertion||||Percentage of participants|||Number
1243949|NCT00552669|Secondary|Target Vessel Revascularization (TVR)|Efficacy end point was TVR as revasacularization of the treated vessel.|18 months|We analyzed the number of vessels treated per group by ITT and the imputation technique was LOCF.|||vessels|||Number
1243950|NCT00552669|Secondary|Major Adverse Cardiovascular Events (MACCE)|Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.|18 Months|It was determinated by ITT and the technique used was LOCF.|||participants|||Number
1243951|NCT00552669|Primary|Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.|Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.|Follow up will be conducted by the coordinating Center at 18 months of follow up|All patients were analyzed for ITT and the imputation technique was LOCF|||US dollars||Standard Deviation|Mean
1243952|NCT00552578|Secondary|Treatment Retention.|"Treatment retention was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses)."|Six months|Analysis was intent-to-treat.|||Participants|||Number
1243953|NCT00552578|Secondary|Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.|Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.|Baseline and six months|"Reported value (number) was the number who reported a better overall quality-of-life to the question: How would you describe your overall level of function now as compared to the time right before you started the study? Responses were recorded as: better, no change, or worse."|||Participants|||Number
1243954|NCT00552578|Primary|Relapse to Substance Abuse|Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.|Six months||||participants|||Number
1243955|NCT00552513|Secondary|In-hospital Major Bleeding||Hospital discharge|||||||
1243956|NCT00552513|Secondary|Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180||180 days|||||||
1243962|NCT00552448|Secondary|Pediatric Asthma Severity Score (Modified Pulmonary Index Score)|Modified Pulmonary Index Score (MPIS): a validated asthma severity score in pediatric population (Carroll CL et al. A modified pulmonary index score with predictive value for pediatric asthma exacerbations, Ann Allergy Asthma Immunol 2005) Consists of: 1) oxygen saturation on room air 2) accessory muscle use 3) inspiratory to expiratory ratio 4) degree of wheezing 5) heart rate 6) respiratory rate Scored observations 0, 1, 2 or 3. Total score range 0 - 18. Mild exacerbation total less than 6, moderate exacerbation 6 – 10, severe exacerbation higher than 10|Discharge from PICU|Participants with available data|||units on a scale||Full Range|Mean
1243963|NCT00552448|Secondary|Total Days of Hospital Admission|This is limited due to non collection by collaborating centers.|Days|Data not collected||||||
1243964|NCT00552448|Primary|Hours Spent in Pediatric ICU|Length of stay (hours) in Pediatric ICU.|Number of hours from admission to discharge from PICU||||Hours||Standard Deviation|Mean
1243965|NCT00552422|Primary|Symptomatic Improvement|The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.|2 months||||participants|||Number
1243966|NCT00552409|Primary|Change in Urine Albumin Excretion|Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.|Baseline, 3 months, and one year|All participants were analyzed|||percent difference||95% Confidence Interval|Mean
1243967|NCT00552396|Secondary|"Number of Evaluable Patients With Stable Disease. Evaluable is Defined as 2 Consecutive M Protein Assessments"|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease|From start of the treatment to end of study or disease progression||||Number of participants|||Number
1243968|NCT00552396|Secondary|Area Under the Plasma-concentration-time Curve [AUC (INF)] of IPH2101 After Cycle 1 Administration|AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Cycle 1.|Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration||||ng*hours/ml||Geometric Coefficient of Variation|Geometric Mean
1243969|NCT00552396|Secondary|Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration|Cmax was obtained from the plasma concentration versus time data after IV administration of IPH2101.|Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1243970|NCT00552396|Primary|Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment|The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT.|From start of the treatment to end of study|All treated participants who received at least one dose of the study drug and were evaluable for DLT|||Number of participants with DLT|||Number
1243971|NCT00552344|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|||percentage of subjects|||Number
1243972|NCT00552344|Secondary|Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)|Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Week 52|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|||μg/mL||95% Confidence Interval|Geometric Mean
1243973|NCT00552344|Secondary|Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)|IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.|Week 262|Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.|||percentage of subjects||95% Confidence Interval|Number
1243974|NCT00552344|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Week 262|Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.|||percentage of subjects||95% Confidence Interval|Number
1243975|NCT00552344|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|From study start to the end of the Safety Follow-up Period (up to 272 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|||percentage of subjects|||Number
1244014|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 2.|Patients on-treatment, data within time windows|baseline to week 2|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
1243976|NCT00552344|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|From study start to the end of the Safety Follow-up Period (up to 272 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|||percentage of subjects|||Number
1243977|NCT00552305|Secondary|Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency|Treatment Period (up to 8 years)|Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.|||percentage of subjects|||Number
1243978|NCT00552305|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)|"Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.~Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency."|Baseline, End of Treatment Period (up to 8 years)|Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.|||percentage change||Full Range|Median
1243979|NCT00552305|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
1243980|NCT00552305|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
1243981|NCT00552305|Primary|Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
1243982|NCT00552279|Secondary|Number of Subjects Completing the 3-dose Vaccination Schedule||After the third vaccine dose||||Participants|||Count of Participants
1243983|NCT00552279|Secondary|Number of Subjects With Pregnancies and Their Outcomes|"Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6~Number of pregnancies and pregnancy outcomes."|During the entire study period (up to Month 18 or Month 12)|Analysis was performed on the Total vaccinated cohort, on pregnant subjects|||Participants|||Count of Participants
1243984|NCT00552279|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)|"Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6.~NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.~An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|During the entire study period (up to Month 18 or up to Month 12)||||Participants|||Count of Participants
1243985|NCT00552279|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day (Days 0-29) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1243986|NCT00552279|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1243987|NCT00552279|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1243988|NCT00552279|Secondary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titer given as GMT.|One month after the second vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity|||EL.U/mL||95% Confidence Interval|Geometric Mean
1244364|NCT00550173|Secondary|Probability of OS at 12 Months|OS time is censored at the date of last contact for participants who were still alive or lost to follow-up.|Month 12|Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.|||percent chance of survival||95% Confidence Interval|Number
1243989|NCT00552279|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies."|One month after the second vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity|||Participants|||Count of Participants
1243990|NCT00552279|Primary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titer given as geometric mean titer (GMT).|One month after the third vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity|||EL.U/mL||95% Confidence Interval|Geometric Mean
1243991|NCT00552279|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies."|One month after the third vaccine dose|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity|||Participants|||Count of Participants
1243992|NCT00552240|Secondary|Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities||baseline to week 52|All treated patients|||participants|||Number
1243993|NCT00552240|Secondary|Proportion of Patients Reporting Rash of Any Severity||baseline to week 52|All treated patients|||participants|||Number
1243994|NCT00552240|Secondary|Proportion of Patients Reporting Hepatic Events of Any Severity||baseline to week 52|All treated patients|||participants|||Number
1243995|NCT00552240|Secondary|Proportion of Patients Reporting CNS Side Effects of Any Severity||baseline to week 52|All treated patients|||participants|||Number
1243996|NCT00552240|Secondary|Incidence of Patients With AIDS Progression at Each Visit|Cumulative incidence of patients with AIDS progression are shown|baseline to week 52|Full Analysis set|||participants|||Number
1243997|NCT00552240|Secondary|Number of Participants With Genotypic Resistance at the Time of Virologic Failure.|Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.|baseline to week 48|Includes only treated patients with data in the specified time window||||||
1243998|NCT00552240|Secondary|Percentage Adherence by Pill Count|Number of pills not returned / number of treatment days in percent (%)|baseline to week 48|All treated patients with data|||percentage adherence||Standard Deviation|Mean
1243999|NCT00552240|Secondary|Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48|using 4-variable Modification of Diet in Renal Disease (MDRD) formula|baseline to week 48|Includes only treated patients with data for the specified time window|||ml/min/1.73m^2||Standard Deviation|Mean
1244000|NCT00552240|Secondary|Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group||baseline to week 48|Not calculated as no data on family history of cardiovascular disease were available||||||
1244001|NCT00552240|Secondary|Change in Framingham Score|Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient’s gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.|baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||percent 10-year risk||Standard Deviation|Mean
1244002|NCT00552240|Secondary|Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||ratio||Standard Deviation|Mean
1244003|NCT00552240|Secondary|Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||mg/dl||Standard Deviation|Mean
1244004|NCT00552240|Secondary|Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||mg/dl||Standard Deviation|Mean
1244005|NCT00552240|Secondary|Change in Fasting Plasma Triglycerides Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||mg/dl||Standard Deviation|Mean
1244006|NCT00552240|Secondary|Change in Fasting Plasma Total Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF).|||mg/dl||Standard Deviation|Mean
1244007|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 48.|Patients on-treatment, data within time windows|baseline to week 48|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
1244008|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 36.|Patients on-treatment, data within time windows|baseline to week 36|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
1244009|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 24.|Patients on-treatment, data within time windows|baseline to week 24|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
1244010|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 12.|Patients on-treatment, data within time windows|baseline to week 12|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
1244011|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 8.|Patients on-treatment, data within time windows|baseline to week 8|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
1244012|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 6.|Patients on-treatment, data within time windows|baseline to week 6|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
1244013|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 4.|Patients on-treatment, data within time windows|baseline to week 4|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
1244015|NCT00552240|Secondary|AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death|"AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi’s sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.~Number of cases (no time-to analysis was performed due to small numbers)."|baseline to week 48|All treated patients|||Participants|||Number
1244016|NCT00552240|Secondary|Number of Patients With Virologic Rebound to >400 Copies/ml|HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)|baseline to week 48|All treated patients|||Participants|||Number
1244017|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment|Results within time windows, patients on-treatment|baseline to week 48|All treated patients|||Participants|||Number
1244018|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment|Results within time windows, patients on-treatment|baseline to week 36|All treated patients|||Participants|||Number
1244019|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment|Results within time windows, patients on-treatment|baseline to week 24|All treated patients|||Participants|||Number
1244020|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment|Results within time windows, patients on-treatment|baseline to week 12|All treated patients|||Participants|||Number
1244021|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment|Results within time windows, patients on-treatment|baseline to week 8|All treated patients|||Participants|||Number
1244022|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment|Results within time windows, patients on-treatment|baseline to week 6|All treated patients|||Participants|||Number
1244023|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment|Results within time windows, patients on-treatment|baseline to week 4|All treated patients|||Participants|||Number
1244024|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment|Results within time windows, patients on-treatment|baseline to week 2|All treated patients|||Participants|||Number
1244025|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment|Results within time windows, patients on-treatment|baseline to week 48|All treated patients|||Participants|||Number
1244026|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment|Results within time windows, patients on-treatment|baseline to week 36|All treated patients|||Participants|||Number
1244027|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment|Results within time windows, patients on-treatment|baseline to week 24|All treated patients|||Participants|||Number
1244028|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment|Results within time windows, patients on-treatment|baseline to week 12|All treated patients|||Participants|||Number
1244029|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment|Results within time windows, patients on-treatment|baseline to week 8|All treated patients|||Participants|||Number
1244030|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment|Results within time windows, patients on-treatment|baseline to week 6|All treated patients|||Participants|||Number
1244031|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment|Results within time windows, patients on-treatment|baseline to week 4|All treated patients|||Participants|||Number
1244032|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment|Results within time windows, patients on-treatment|baseline to week 2|All treated patients|||Participants|||Number
1244033|NCT00552240|Secondary|Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response|HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)|baseline to week 24 and week 48|All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.|||Participants|||Number
1244034|NCT00552240|Secondary|Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml||baseline to week 48|All responders|||days||Inter-Quartile Range|Median
1244035|NCT00552240|Secondary|Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants|Time to response whereby patients withdrawing early were censored after their withdrawal|baseline to week 48|All treated patients|||days||Inter-Quartile Range|Median
1244036|NCT00552240|Secondary|Number of Participants With Virologic Success (FDA Definition)|HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).|baseline to week 48|All treated patients.|||Participants|||Number
1244037|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48|HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.|baseline to week 48|Only includes treated patients with data in the Week 48 time window.|||Participants|||Number
1244038|NCT00552240|Secondary|Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm|HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.|baseline to week 48|All treated patients. Early withdrawals were considered failures.|||Participants|||Number
1244039|NCT00552240|Primary|Number of Participants With Virologic Response (VR)|VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.|baseline to week 48|All treated patients. Early withdrawals were considered failures.|||participants|||Number
1244040|NCT00552188|Secondary|Change From Baseline in Plaque Imaging After 6 Weeks|To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the TBR from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18FDG uptake measured with PET in patients after 6 weeks of daily dosing.|Baseline and 6 Weeks|Evaluable Population|||TBR||95% Confidence Interval|Least Squares Mean
1244041|NCT00552188|Primary|Change From Baseline in Plaque Imaging After 24 Weeks|To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.|Baseline and 24 Weeks|Evaluable Population|||TBR||95% Confidence Interval|Least Squares Mean
1244042|NCT00552175|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244043|NCT00552175|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244044|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Interference Scores at Week 12|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244045|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244046|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Severity Scores at Week 12|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244047|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244048|NCT00552175|Secondary|Patient Global Impression of Improvement Scale at Week 12|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244049|NCT00552175|Secondary|Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244050|NCT00552175|Secondary|Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries|Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244051|NCT00552175|Secondary|Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)|Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1245562|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244052|NCT00552175|Secondary|Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries|Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244053|NCT00552175|Primary|Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)|Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
1244054|NCT00552110|Primary|Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score|Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.|from baseline to hour 4 on Day 1|Intention to treat: all randomized subjects who had taken at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
1244055|NCT00552110|Primary|Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15|Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.|15 days of treatment|Intention to treat (ITT): all randomized subjects who had taken at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
1244056|NCT00552084|Primary|Documented Recurrence of Atrial Fibrillation/Atrial Flutter|Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.|Measured at Week 24 or exit||||percentage of participants|||Number
1244057|NCT00552071|Secondary|Serum IGF-1 Level|Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.|3 months|Subjects were regrouped for analysis by treatment. Serum IGF-I levels after 3 monthly octreotide LAR injections with ultrasound guidance were compared to Serum IGF-I levels obtained after 3 monthly octreotide LAR injection without ultrasound guidance.|||percentage of upper limit of normal||Standard Deviation|Mean
1244058|NCT00552071|Primary|Plasma Octreotide Level After Each Treatment Phase|Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.|3 months|Subjects were regrouped for analysis by treatment. Octreotide levels after 3 monthly octreotide LAR injections with ultrasound guidance were compared to octreotide levels obtained after 3 monthly octreotide LAR injection without ultrasound guidance.|||pg/mL||Standard Deviation|Mean
1244059|NCT00552058|Secondary|Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6|The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose|||percentage of subjects||95% Confidence Interval|Number
1244060|NCT00552058|Secondary|Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6|The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244061|NCT00552058|Secondary|Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6|The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244062|NCT00552058|Secondary|Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6|The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244063|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244064|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244065|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 4|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 198 and 184 subjects respectively are included in this summary and have assessments at both Weeks 0 and 4. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||score on a scale||Standard Deviation|Mean
1244066|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0 to Week 2|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 204 and 198 subjects respectively are included in this summary and have assessments at both Weeks 0 and 2. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||score on a scale||Standard Deviation|Mean
1244067|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 4|The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244068|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 2|The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244069|NCT00552058|Secondary|Percentage of Subjects in Clinical Remission at Week 4|The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244070|NCT00552058|Secondary|Percentage of Subjects in Clinical Remission at Week 2|The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244071|NCT00552058|Secondary|Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6|The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.|Week 0 to Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 196 and 187 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||score on a scale||Standard Deviation|Mean
1244072|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0 to Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 192 and 183 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||score on a scale||Standard Deviation|Mean
1244073|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244074|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 6|The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244075|NCT00552058|Primary|Percentage of Subjects in Clinical Remission at Week 6|The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
1244076|NCT00552032|Secondary|Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score|"18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126).~Grading was as follows:~Scores < 60 suggest a slight impact on health related quality of life (HRQL)~Scores 60-80 suggest a moderate impact~Scores over 80 suggest a great impact"|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 subjects were included in the ITT population. The ITT population included all randomized participants who received >=1 dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.~1 participant in Placebo group did not answer this questionnaire at baseline."|||Score on a scale||Standard Deviation|Mean
1244077|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 28 randomized participants were between 8-12 years old, 15 participants in MFNS & 13 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.|||Score on a scale||Standard Deviation|Mean
1244078|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 5 and 7 years old, 28 participants in MFNS & 24 subjects in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.|||Score on a scale||Standard Deviation|Mean
1244079|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 2 and 4 years old, 23 participants in MFNS & 29 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.|||Score on a scale||Standard Deviation|Mean
1244080|NCT00552032|Secondary|Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe|PSQ consists of 90 variables divided into 3 different factors:snoring, somnolence, and behavior. All positive Snoring and Somnolence answers scored with Yes=1 and No=0, and scores averaged to obtain a total score between 0.00 and 1.00. Behavior factor scored between 1-3, and scores averaged for total score of 1 to 3. Increased scores indicate increasing abnormality of sleep. Based on determined cut-offs, participants were categorized as having mild, moderate, or severe discomfort due to interference of sleep.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 participants were included in the ITT population. The ITT~population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point."|||Participants|||Number
1244081|NCT00552032|Secondary|Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa|Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||cm^3||Standard Deviation|Mean
1244082|NCT00552032|Secondary|Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa|"Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.~Measurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) & were reported in cm^3."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||cm^3||Standard Deviation|Mean
1244083|NCT00552032|Secondary|Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done|Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||Participants|||Number
1244084|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||cm^3/sec||Standard Deviation|Mean
1244085|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||cm^3/sec||Standard Deviation|Mean
1244086|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||Pa/cm^3/sec||Standard Deviation|Mean
1244087|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants aged 7-11 years old (MFSN=19, Placebo=20).|||Pa/cm^3/sec||Standard Deviation|Mean
1245563|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population||Week 104|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244088|NCT00552032|Secondary|Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction|Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Participants|||Number
1244089|NCT00552032|Secondary|Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic|Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Participants|||Number
1244090|NCT00552032|Secondary|Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation|Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Participants|||Number
1244091|NCT00552032|Secondary|Number of Participants With Otoscopic Results of: Normal or Abnormal|Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Participants|||Number
1244092|NCT00552032|Secondary|Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done|Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 participants were included in the ITT~population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point."|||Participants|||Number
1244093|NCT00552032|Secondary|Total Frequency Symptom Scores: AM & PM|Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM & PM (a difference of 12 hours) & were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Score on a scale||Standard Deviation|Mean
1244094|NCT00552032|Secondary|Total Severity Symptom Scores: Morning and Evening (AM & PM)|Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM & PM (a difference of 12 hours) & were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction & discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Score on a scale||Standard Deviation|Mean
1244095|NCT00552032|Primary|Change From Baseline in Adenoid/Choana (A/C) Index Grade|Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.|Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)|A total of 132 participants were included in the intent-to-treat (ITT) population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data are summarized in terms of the number of participants providing data at the relevant time point.|||Score on a Scale||Standard Deviation|Mean
1244096|NCT00551759|Primary|Proportion of Patients With Pathologic Complete Response|After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen.|At time of surgery (which occurred 63 to 91 days after study entry)|Eligible and treated patients|||Proportion of patients||90% Confidence Interval|Number
1244097|NCT00551746|Secondary|The Impact of Polymorphism in Haemostatic Genes on Variation in Platelet Function Among Participants Based on Long-term PGJ Consumption.||90-days|||||||
1244098|NCT00551746|Secondary|Compare Platelet Inhibitory Pathways of ADP,TRAP, PMA, Arachadonic Acid Between PGJ and Placebo.|The platelet inhibitory pathway in which PGJ functions by performing platelet aggregation tests using agonists for the 4 major platelet activation pathways: ADP,thrombin receptor-activator peptide (TRAP), phorbol 12-myristate 13-acetate (PMA), arachadonic acid(10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.|90-days|||||||
1244099|NCT00551746|Primary|Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo|Platelet aggregation was measured using the agonist ADP (10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.|90-days|The number of participants evaluated were those who had both a baseline and visit 4 platelet aggregation and platelet-dependant inflammatory marker values|||percent||Standard Deviation|Mean
1244100|NCT00551707|Secondary|To Assess the Efficacy of CRx-102 Compared to Placebo Using ACR 20 Calculated From Baseline to Day 98|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to 98 Days|||||||
1244101|NCT00551707|Primary|Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|Day 98|As treated population|||mg/L||Full Range|Median
1244102|NCT00551707|Secondary|To Assess the Superiority of CRx-102 Compared to Prednisolone and Dipyridamole Using American College of Rheumatology Rating Scale (20% or More Improvement; ACR20) Calculated From Baseline to Day 98 in Subjects With Active Rheumatoid Arthritis|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to day 98|||||||
1244103|NCT00551707|Secondary|Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to day 98|As treated population|||percentage of change from baseline||Full Range|Median
1244104|NCT00551642|Secondary|Methemoglobin Level||Baseline, then 24 hours, 2-6 days, Day 7 and Day 14 of treatment|||||||
1244105|NCT00551642|Secondary|Adverse Events||Study Duration|||||||
1244106|NCT00551642|Secondary|Arterial Oxygen Saturation by Pulse Oximetry||Study Duration|||||||
1244107|NCT00551642|Secondary|Vital Signs||Study Duration|||||||
1244108|NCT00551642|Primary|Survival||36 Weeks GA|||||||
1244109|NCT00551642|Primary|Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress|The primary outcome was determined by assessment of survival and incidence of BPD,which was defined by the need for supplemental oxygen at 36 weeks gestational age (GA); an infant who was alive without BPD at 36 weeks GA was counted as success; an infant who died or had BPD at 36 weeks GA was counted as a failure.|36 weeks gestational age||||participants alive without BPD|||Number
1244110|NCT00551525|Secondary|Freedom From Progression (FFP) Rate at 2 Years|"Progression is defined as biochemical (PSA) failure at any time for 2 years after prostatic fossa radiation therapy (RT), initiation of systemic therapy, or clinical failure. Biochemical failure is defined as a rise of 0.2 ng/ml or more above the nadir PSA after completion of RT followed by another higher value, or a continued rise in the serum PSA despite RT. FFP rate at 2 years was to be compared to that predicted by the Kattan Nomograms. See Limitations and Caveats section."|From randomization to 2 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1244111|NCT00551525|Secondary|Acute and Late Radiotherapy-Related Adverse Events|The number of patients who experienced a grade 1-5 radiation-related adverse events within 90 days of the start of radiotherapy (acute) and after 90 days (late). Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. Multivariate logistic regression was used to model the association of clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, Gleason score (<8 vs. 8-10[reference level]), and age with the occurrence of any acute radiotherapy-related adverse event. Odds ratios and the respective 95% confidence intervals were computed for each factor. Per the protocol, late adverse events were not analyzed.|90 days from start of radiotherapy|Eligible patients with adverse event data|||participants|||Number
1244112|NCT00551525|Secondary|Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)|"Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. The treatment-related attribution includes definitely, probably or possibly related to treatment. The treatment-related adverse events are:~HEMATOLOGIC Platelet grade 3-5 White blood cell count (WBC) grade 3-5 Hemoglobin grade 3-5 Any secondary leukemia’s~HEMORRHAGE/BLEEDING Hemorrhage, gastrointestinal - anus, rectum grade 3-5 Hemorrhage, genitourinary - bladder, prostate, urethra grade 3-5~SAMARIUM 153-RELATED GRADE 5 ADVERSE EVENT PRIOR TO TREATMENT OF RADIATION."|Twelve weeks from the date of Samarium 153 infusion|Eligible patients with adverse event data|||percentage of participants|||Number
1244423|NCT00549770|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit.|baseline, week 8|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||mmHg||Standard Error|Least Squares Mean
1244113|NCT00551525|Secondary|Number of Patients With Hematologic Toxicity at 12 Weeks|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Hematological toxicities consist of platelet grade 3-5, white blood cell grade 3-5, hemoglobin grade 3-5, and any secondary leukemia's.|Twelve weeks from the date of Samarium 153 infusion.|Eligible patients who started study treatment|||Participants|||Count of Participants
1244114|NCT00551525|Secondary|Completion of Therapy|The completion of protocol treatment is defined as receiving at least 64.8 Gy radiation after the Samarium 153 injection. The null hypothesis that the proportion of the number of patients who complete the protocol treatment (the Samarium 153 and the radiation therapy) is less than or equal to 0.5 was tested using an exact test for a binomial proportion. If the true treatment completion proportion is 0.8, then the statistical power of a one-sided 0.378 level exact binomial test of proportion would be 94.1% with the sample size of 26. Therefore any number of analyzable patients greater than 26 patients provides enough power for this endpoint.|90 days from the end of radiation therapy.|All eligible patients who started treatment and did not withdraw consent prior to 90 days from the end of radiation therapy|||percentage of participants||95% Confidence Interval|Number
1244115|NCT00551525|Primary|Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration|A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming’s Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.|Twelve weeks from the date of Samarium 153 infusion.|All eligible patients who received Samarium 153 with at least 12 weeks follow-up from the injection|||percentage of participants|||Number
1244116|NCT00551460|Secondary|Frequency of Toxicities|Adverse events that were possibly, probably or definitely related to study drug are reported.|Up to 3 years|The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.|||Participants|||Number
1244117|NCT00551460|Primary|Mortality Rate at 6 Weeks||6 weeks|The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.|||percentage of participants||95% Confidence Interval|Number
1244118|NCT00551460|Primary|Continuous Complete Remission at 3 Years|Binary variable: yes if the patient achieves complete remission and remains in continuous complete remission until at least 3 years after entering the study; otherwise no.|3 years|The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.|||percentage of participants||95% Confidence Interval|Number
1244119|NCT00551421|Secondary|Overall Survival|The duration of time from start of study treatment to death from any cause.|The duration of time from start of study treatment to death from any cause.||||months||95% Confidence Interval|Median
1244120|NCT00551421|Secondary|Progression-free Survival|The duration of time from start of study treatment to time of objective disease progression or death.|The duration of time from start of study treatment to time of objective disease progression or death.||||months||95% Confidence Interval|Median
1244121|NCT00551421|Primary|Objective Tumor Response Rate Defined as the Proportion of Patients With a Best Overall Response of CR or PR, Per RECIST Criteria (Phase II)|Objective tumor response rate defined as the proportion of patients with a best overall response of CR or PR, per RECIST criteria (Phase II).|Best tumor response from time period of start of study treatment to study discontinuation.||||percentage of patients|||Number
1244122|NCT00551421|Primary|Recommended Phase II Dose of Pertuzumab When Administered in Combination With Cetuximab (Phase I)|The regimen was deemed intolerable so there was no recommended phase II dose.|28 days|||||||Number
1244123|NCT00551369|Secondary|Assessment of Predictive Value of Blood Markers for Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2|Assess if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2 year primary tumor control and predict for grade ≥ 2 treatment-related adverse events. Unfortunately, there were not enough specimens submitted to perform this analysis. The specimens that were collected remain in the NRG Oncology Biobank and are available to be combined with other specimens from other studies for an appropriately powered project.|From start of treatment to 2 years.|||||||
1244124|NCT00551369|Secondary|Level of Comorbidity Burden on Morbidity and Efficacy||From start of treatment to end of follow-up.||2019-05-31|05/2019||||
1244125|NCT00551369|Secondary|Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years|PTF: the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure) within the first two years after start of SBRT. RF: the development of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum within the first two years after start of SBRT. MD: the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer within the first two years after start of SBRT. DFS: the state of being alive without development of progressive disease, with failure considered the earliest development of either progression or death. OS: the state of being alive, with failure is considered death due to any cause.|From start of treatment to 2 years.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1244473|NCT00549549|Secondary|Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient’s Assessment of Pain Intensity|The Patient’s assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline, Day 2|ITT and LOCF|||Participants|||Number
1244126|NCT00551369|Secondary|Other Grade 3-5 Adverse Events|The development of any treatment-related toxicity not from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy|From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1244127|NCT00551369|Secondary|Rate of Treatment-related Grade 3 or 4 Toxicity|The development of any treatment-related toxicity from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy|From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1244128|NCT00551369|Primary|Primary Tumor Control at 2 Years|Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.|From start of treatment to 2 years.|All eligible patients who started study treatment|||percentage of patients||95% Confidence Interval|Number
1244129|NCT00551291|Secondary|Percentage of Participants With at Least One Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|Up to approximately 2 years||||percentage of participants|||Number
1244130|NCT00551291|Primary|Mean Number of Blood Transfusions Per Visit||Up to approximately 2 years||||transfusions/visit||Standard Deviation|Mean
1244131|NCT00551291|Primary|Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement|International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment.|Up to approximately 2 years||||percentage of participants|||Number
1244132|NCT00551213|Secondary|Change From Baseline in Tumor Growth Rate|Tumor growth rate was assessed by CT or MRI scans using RECIST criteria at Screening, at every 8 weeks of robatumumab treatment and at post study. For Pre Baseline 1, tumor growth rate=(sum of longest diameter of target lesions at Baseline – the most recent prior to Baseline)/duration between Baseline and Pre Baseline. For all other cycles, tumor growth rate=(sum of longest diameter of target lesions at a cycle – Baseline)/ duration between Baseline and the cycle. The cycles presented below are relative to the first dose of robatumumab in Period 1.|Baseline and up to approximately 22 weeks|All participants who received ≥1 dose of robatumumab in Periods 1 and 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.|||mm/day||Standard Deviation|Mean
1244133|NCT00551213|Secondary|Best Overall Tumor Response Per Central Review|Tumor response was assessed by CT or MRI scan using RECIST v1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the LD for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of robatumumab were included in the analysis.|||Participants|||Number
1244134|NCT00551213|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to last dose of study drug (Up to approximately 18 weeks)|All participants who received ≥1 dose of study drug were included in the analysis.|||Participants|||Number
1244146|NCT00551174|Primary|Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months|Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline,12, 24 and 36 months|ITT population: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 383, 2 mg group = 348; Month 24: 3 mg group = 374, 2 mg group = 332; Month 36: 3 mg group = 349, 2 mg group = 314.|||Percent change||Standard Deviation|Mean
1244135|NCT00551213|Secondary|Best Overall Tumor Response Per Investigator Review|Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) scans using RECIST v 1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of robatumumab were included in the analysis.|||Participants|||Number
1244136|NCT00551213|Secondary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of study drug were included in the analysis.|||Participants|||Number
1244137|NCT00551213|Primary|Number of Participants With a >20% Decrease in Positron Emission Tomography (PET)-Assessed Tumor Glucose Metabolism: Fluorodeoxyglucose (FDG) Standardized Uptake Value (SUV) in the Target Lesion|FDG-PET was used in this study to detect the biological activity of modulation of the target within the tumor. Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 was used to select the target lesion. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were identified as target lesions and recorded and measured at Baseline. The changes in SUVmax were calculated using the formula: (endpoint SUVmax – baseline SUVmax)/baseline SUVmax as a percentage. If multiple lesions had been measured at a visit, percentages calculated for all target lesions were averaged to find the decrease during the treatment period per participant. FDG SUVmax responder was defined as participants with >20% decrease in SUVmax after the first cycle of robatumumab in Period 2.|After the first robatumumab dose in Period 2 (Up to approximately 4 weeks after first robatumumab dose in Period 1)|All participants who received ≥1 dose of robatumumab in Periods 1 and 2 and had SUV data before and after the first dose of robatumumab in Period 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.|||Participants|||Number
1244138|NCT00551200|Primary|Number of Subjects Experienced Serious Adverse Events||during the period subjects on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)||||participants|||Number
1244139|NCT00551200|Primary|Number of Subjects Experienced Adverse Events||during the period on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)||||participants|||Number
1244140|NCT00551200|Secondary|Drug Preference for HPN-100 or Buphenyl® (as Assessed by Global Preference Question)||End of Study||||participants|||Number
1244141|NCT00551200|Primary|Venous Ammonia Levels at the Peak and Mean TNUAC Time-normalized Area Under the Curve)|Data were collected at pre-first dose and at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post first dose.|At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone), and at steady state (1 week) after each dose escalation||||μmol/L|concentration of ammonia|Standard Deviation|Mean
1244142|NCT00551200|Secondary|Pharmacokinetics (Plasma and Urine PK Parameters of Study Drugs and Their Metabolites)|measured AUC0-24 (Area under the curve from time 0 (pre-dose) to 24 hours) for each metabolite in plasma. Data were collected at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post-first dose.|At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone)||||μg*h/mL|plasma|Standard Deviation|Mean
1244143|NCT00551174|Secondary|Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months|Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline, 6 months|Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 89, 2 mg group: 93.|||Percent change||Standard Deviation|Mean
1244144|NCT00551174|Secondary|Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months|Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)|Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 87, 2 mg group: 92; Month 12: 3 mg group = 92, 2 mg group = 92; Month 24: 3 mg group = 83, 2 mg group = 85; Month 36: 3 mg group = 75, 2 mg group = 76.|||Percent change||Standard Deviation|Mean
1244145|NCT00551174|Secondary|Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months|Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline,12, 24 and 36 months|ITT populations: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 381, 2 mg group = 347; Month 24: 3 mg group = 371, 2 mg group = 330; Month 36: 3 mg group = 349, 2 mg group = 314.|||Percent change||Standard Deviation|Mean
1244156|NCT00551135|Secondary|Participants With Physician Contacts Post-discharge|"Number of participants who answered yes to the Post-Surgery Contact question: From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"|24 and 72 hours (h) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations|||participants|||Number
1244147|NCT00551161|Primary|Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor|Ratios of myo-inositol (mI), N-acetylaspartate (NAA), total creatine (Cr), and choline (Cho) by single voxel 1H MRS (proton magnetic resonance spectroscopy). Mean (± SD) metabolite levels (normalized to T2-corrected water signal intensity) and metabolite ratios for Alzheimer's disease subjects at baseline (t0), after 24 weeks of ongoing monotherapy with stable-dose cholinesterase inhibitor (t1), and after another 24 weeks of combination therapy with memantine in addition to stable-dose cholinesterase inhibitor (t2). The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 [(t2 – t1) – (t1 – t0)].|Baseline, 24 weeks, and 48 weeks|Per protocol|||ratio (normalized to T2-corrected water||Standard Deviation|Mean
1244148|NCT00551135|Secondary|Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)|NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 [no pain] to 10 [worst pain imaginable]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.|||scores on a scale||Standard Deviation|Mean
1244149|NCT00551135|Secondary|Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory–Short Form (mBPI-sf)|m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.|||scores on a scale||Standard Deviation|Mean
1244150|NCT00551135|Secondary|Participants With Chronic Postoperative Pain|"Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: In the last 24 hours, have you had pain in the area affected by your surgery?)"|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||participants|||Number
1244151|NCT00551135|Secondary|Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS)|PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.|Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.|||scores on a scale||Standard Error|Least Squares Mean
1244152|NCT00551135|Secondary|Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing.|Baseline and Days 1 and 7 post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.|||scores on a scale||Standard Error|Least Squares Mean
1244153|NCT00551135|Secondary|Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.|3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on a scale||Standard Error|Least Squares Mean
1244154|NCT00551135|Secondary|Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.|Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.|||scores on scales||Standard Error|Least Squares Mean
1244155|NCT00551135|Secondary|Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score|Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject’s mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on a scale||Standard Error|Least Squares Mean
1244157|NCT00551135|Secondary|Participants With Wound Healing Complications|Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.|Day 7 post surgery (PS) and up to 30 days PS|Operated subjects within the safety population. Safety population=all randomized subjects administered at least 1 dose of study drug and for whom at least 1 post-baseline safety evaluation was obtained.|||participants|||Number
1244158|NCT00551135|Secondary|Subject Global Evaluation of Study Medication (GESM)|GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.|24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations|||participants|||Number
1244159|NCT00551135|Secondary|Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)|OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr).|3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.|||participants|||Number
1244160|NCT00551135|Secondary|Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)|OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 [none] to 10 [10 CMEs]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 [none] to 9 [9 CMEs]).|3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on a scale||Standard Error|Least Squares Mean
1244161|NCT00551135|Secondary|Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study|Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.|End of Surgery through Day 7 post surgery|MITT; data from 1 site excluded due to GCP deviations. Amount of antiemetic rescue medications not analyzed as planned.|||mg||Standard Error|Least Squares Mean
1244162|NCT00551135|Secondary|Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery|Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.|24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). During surgery data not analyzed as planned.|||mg||Standard Error|Least Squares Mean
1244163|NCT00551135|Secondary|Daily Sleep Interference Rating Scale (DSIRS) Score|DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.|Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on a scale||Standard Error|Least Squares Mean
1244164|NCT00551135|Secondary|Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)||Day 1|MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.|||hours||Standard Error|Least Squares Mean
1244165|NCT00551135|Secondary|Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)|PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.|Day 1|MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.|||hours||Standard Error|Least Squares Mean
1244166|NCT00551135|Secondary|Time From End of Surgery to First Rescue Medication|Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.|Day 1 through Day 7 post surgery|MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.|||hours||Standard Error|Least Squares Mean
1244167|NCT00551135|Secondary|Numeric Rating Scale (NRS): Average Pain|NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).|2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
1244168|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)|NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).|1 through 48 hours post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations.|||score on scale||Standard Error|Least Squares Mean
1244185|NCT00551031|Primary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post vaccination|Serum antibody titers GMTs were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1244169|NCT00551135|Secondary|Numerical Rating Scale (NRS): Current Pain at Rest|NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).|2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
1244170|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing|NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).|1 hour through 48 hours post surgery|MITT; 1 site excluded for GCP deviations; n=subjects with analyzable data at observation (pregabalin 50, 150, and 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
1244171|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Coughing|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
1244172|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Walking|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
1244173|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Sitting|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
1244174|NCT00551135|Primary|Modified Brief Pain Inventory–Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery|m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).|24 hours post surgery|Modified Intent-to-Treat Population (MITT): all subjects included in intent-to-treat population who took study medication 12 and 2 hours prior to surgery, had no complications during herniorrhaphy, and had the post-surgery primary efficacy measurement. Data from 1 site excluded due to Good Clinical Practices (GCP) deviations.|||scores on scale||Standard Error|Least Squares Mean
1244175|NCT00551070|Secondary|Overall Survival||Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
1244176|NCT00551070|Primary|Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.||Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment|Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available|||ng/mL||Inter-Quartile Range|Median
1244177|NCT00551070|Primary|Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.||Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment|Eligible and Treated Patients with all pharmacokinetic time points available|||ng x hr/mL||Inter-Quartile Range|Median
1244178|NCT00551070|Primary|Adverse Events (Grade 3 or Higher) During First Cycle of Treatment||Cycle 1|Eligible and treated patients.|||percentage of patients||95% Confidence Interval|Number
1244179|NCT00551070|Secondary|Number of Courses Received||Every cycle|Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment.|||courses||Inter-Quartile Range|Median
1244180|NCT00551070|Secondary|Progression-free Survival||Every other cycle|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1244181|NCT00551070|Primary|Tumor Response|Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0|Every other cycle|Eligible and treated patients|||percentage of patients||90% Confidence Interval|Number
1244182|NCT00551031|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|"Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis.~Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills"|Days 0 through 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent to treat population.|||Participants|||Number
1244183|NCT00551031|Primary|Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per protocol population.|||Percentage of Participants|||Number
1244184|NCT00551031|Primary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine|Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.|Day 28 post-vaccination|Serum antibody titers were assessed in the per protocol population.|||Percentage of Participants|||Number
1244186|NCT00550953|Secondary|Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG|Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of randomised treatment to 24 hours post last dose of randomised treatment|Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or T40 during the double-blind treatment period.|||participants|||Number
1244187|NCT00550953|Secondary|Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)|"Optimal, normal, high normal blood pressure were defined as follows:~Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg~Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg~High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg"|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
1244188|NCT00550953|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
1244189|NCT00550953|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
1244190|NCT00550953|Secondary|Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
1244191|NCT00550953|Secondary|Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
1244192|NCT00550953|Secondary|Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||mmHg||Standard Error|Mean
1244193|NCT00550953|Primary|Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||mmHg||Standard Error|Mean
1244194|NCT00550862|Secondary|Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites||12 Weeks|||||||
1244195|NCT00550862|Secondary|Alanine Aminotransferase (ALT)|Mean percent change in serum alanine aminotransferase (ALT) from baseline to Day 85/early termination.|Baseline and 12 weeks||||Percent (%) change||Standard Deviation|Mean
1244196|NCT00550862|Secondary|Serum Gamma-Glutamyl Transpeptidase (GGT)|Percent change in serum gamma-glutamyl transpeptidase (GGT) from baseline to Day 85/early termination.|Baseline and 12 weeks||||Percent (%) change||Standard Deviation|Mean
1244197|NCT00550862|Primary|Alkaline Phosphatase (ALP).|The primary efficacy endpoint was the relative (%) change in plasma ALP from pretreatment values. The prestudy consensus opinion of the investigators was that a placebo-substracted ALP fall of ≥ 10% would be clinically significant.|Baseline and 12 weeks||||Percent (%) change||Standard Deviation|Mean
1244198|NCT00550836|Secondary|Frequency and Severity of Observed Adverse Effects|"Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported.~A complete listing of all adverse events is reported in the Adverse Events section."|Up to 2 years|All evaluable patients were included in this analysis.|||participants|||Number
1244199|NCT00550836|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment. The time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 2 years|All eligible treated patients were included in this analysis.|||months||95% Confidence Interval|Median
1247016|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg leg discomfort scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort|4 weeks|FAS using imputed values|||Unit on a Scale||Standard Error|Mean
1244200|NCT00550836|Secondary|Progression-free Survival|Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first. Progression is defined as at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. The progression-free survival curves will be compared between the 2 arms using a log-rank test.|Up to 2 years|All treated patients were included in this analysis.|||months||95% Confidence Interval|Median
1244201|NCT00550836|Secondary|Confirmed Response Rate|Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|Up to 2 years|All patients that started protocol treatment and were evaluated were included in this analysis.|||rate of confirmed response||95% Confidence Interval|Number
1244202|NCT00550836|Primary|Overall Survival|Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.|Up to 2 years|All treated patients that were eligible were included in the analysis.|||months||95% Confidence Interval|Median
1244203|NCT00550771|Secondary|Number of Participants Who Survived Without Relapse|"Relapse-free survival would have been determined by Kaplan-Meier method.~This was not calculated, since the 2 year follow-up was curtailed."|Approximately 2 years|||||||
1244204|NCT00550771|Secondary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|During 1 year of trastuzumab therapy|ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.|||Participants|||Number
1244205|NCT00550771|Secondary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|During the 8 courses of chemotherapy|ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.|||Participants|||Number
1244206|NCT00550771|Primary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment|"ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.~Each participant could not contribute more than 1 event."|||Participants|||Number
1244207|NCT00550745|Secondary|Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination|"Only Serious Adverse Events were collected and analyzed for this study.~A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|6 months|"All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.~Death - Number of subjects that had a fatal serious adverse event with an onset date within the 182 day reporting period. The date of death may have occurred after 182 days."|||Participants|||Number
1244208|NCT00550745|Primary|Serious Adverse Events Reported Within 42 Days Postvaccination|"Only Serious Adverse Events were collected and analyzed for this~study.~A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|42 Days|"All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.~Death - Number of subjects that had a fatal serious adverse event with an onset date within the 42 day reporting period. The date of death may have occurred after 42 days."|||Participants|||Number
1244209|NCT00550732|Secondary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 12 months|All enrolled participants who received at least one dose of study medication.|||Number of participants|||Number
1247017|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort|8 weeks|FAS using imputed values|||Unit on a Scale||Standard Error|Mean
1244210|NCT00550732|Secondary|Number of Participants With Response to Posaconazole in Combination Therapy|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 6 months|The proportion of participants with response to posaconzole who received a prior combination antifungal regimen is not reported as per recommendation from the Safety and Steering Committee since only 1 participant was evaluable for this outcome measure.||||||
1244211|NCT00550732|Secondary|Overall Survival at 3 Months|Total number of participant survivors was assessed at 3 months.|3 months|All enrolled participants|||Percentage of Participants|||Number
1244212|NCT00550732|Secondary|Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug|Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection.|Up to 6 months|The Efficacy Population included those participants with a visit 6 months after the last dose.|||Percentage of participants|||Number
1244213|NCT00550732|Secondary|Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 26 weeks|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.|||Percentage of Participants|||Number
1244214|NCT00550732|Secondary|Percentage of Participants With a CR or PR by 12 Weeks|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 12 Weeks|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.|||Percentage of participants|||Number
1244215|NCT00550732|Secondary|Number of Participants With ≥50% Decrease in Lesion Size or Number|Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease.|Up to 6 months|This outcome measure was not reported as the Safety and Steering Committee (SSC) no longer considered it relevant based on revised Mycoses Study Group and European Organization for Research and Treatment of Cancer (MSG/EORTC) Consensus Criteria.||||||
1244216|NCT00550732|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 6 months|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.|||Percentage of participants|||Number
1244217|NCT00550680|Secondary|Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion|The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|All Enrolled Population: Includes all participants enrolled into the study regardless of treatment received.|||participants|||Number
1244218|NCT00550680|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 17 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; number (n) of participants who entered each treatment period was reported.|||percentage of participants|||Number
1244219|NCT00550680|Secondary|Mean Time Spent in the Target Range for Hb During the EEP|During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population|||days||Standard Deviation|Mean
1244220|NCT00550680|Secondary|Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP|During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
1244221|NCT00550680|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Intent-to-Treat (ITT) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment.|||g/dL||Standard Deviation|Mean
1244250|NCT00550537|Secondary|Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
1244222|NCT00550680|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Per Protocol (PP) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment, and who fulfilled inclusion/exclusion criteria per study protocol.|||percentage of participants||95% Confidence Interval|Number
1244223|NCT00550654|Secondary|Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy|Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.|Baseline and prior to termination of systemic therapy or protocol withdrawal|No data/specimens were collected. Study was terminated due to poor accrual.||||||
1244224|NCT00550654|Secondary|Pain at Sites of Metastases|Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.|One and three months of follow up|No data/specimens were collected. Study was terminated due to poor accrual.||||||
1244225|NCT00550654|Secondary|Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis|Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.|One to three months of followup|No data/specimens were collected. Study was terminated due to poor accrual.||||||
1244226|NCT00550654|Secondary|12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment|Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion.|12 months|No data/specimens were collected. Study was terminated due to poor accrual.||||||
1244227|NCT00550654|Secondary|Median Time to Local Progression|Interval from initiation of treatment on protocol to symptomatic or radiographic progression.|6-12 months|No data/specimens were collected. Study was terminated due to poor accrual.||||||
1244228|NCT00550654|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|9 months, 11 days||||Participants|||Number
1244229|NCT00550654|Primary|6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease|Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.|6 months|No data/specimens were collected. Study was terminated due to poor accrual.||||||
1244230|NCT00550589|Secondary|Changes in Gene Expression in Perianal HSIL After Exposure to Cidofovir as Assessed by RNA Microarray Analysis||Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The gene expression analysis was not done||||||
1244231|NCT00550589|Secondary|Distribution of Abnormally Methylated Genes Among HSIL, Low-grade Squamous Intraepithelial Lesions, and Normal Perianal Skin||Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The gene analysis was not done||||||
1244232|NCT00550589|Secondary|Identification of Abnormally Methylated Genes in Perianal Dysplasia|Identification of abnormally methylated genes in perianal dysplasia|Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The lab analysis of genes was not performed||||||
1244233|NCT00550589|Secondary|Identification of HPV-DNA Types Present in the Anus|Number of patients with HPV16 type present in the anus from anal swab or cytobrush at baseline|Baseline|Number of patients with anal swabs or cytobrush results at baseline|||participants|||Number
1244234|NCT00550589|Secondary|Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA|Number of patients who cleared HPV among those who had a complete or partial response|6 weeks after treatment discontinuation|Participants who had a partial or complete response and for whom pre and post-treatment HPV data were available|||participants|||Number
1244235|NCT00550589|Secondary|Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue|Number of patients with HPV16 at baseline in perianal HSIL and normal perianal tissue|Baseline|Number of patients with tissue samples available at baseline|||participants|||Number
1244236|NCT00550589|Primary|Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0|Number of study patients who had a serious adverse event|Every 2 weeks on study, 6 weeks after treatment discontinuation|All enrolled patients|||participants|||Number
1244237|NCT00550589|Primary|Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL)||6 weeks after treatment discontinuation||||proportion of participants|||Number
1244251|NCT00550537|Primary|Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
1244252|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: Arrhythmia|Incidence of potentially clinically significant ECG abnormalities: arrhythmia|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244238|NCT00550550|Secondary|Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS|The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment.|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry for the rhinoconjunctivitis quality-of-life measure.|||Units on a Scale||Standard Error|Mean
1244239|NCT00550550|Secondary|Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS|The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication.|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
1244240|NCT00550550|Secondary|Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS|The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst).|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
1244241|NCT00550550|Primary|Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)|The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication.|From the Start of the GPS to the End of the GPS|The Full Analysis Set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
1244242|NCT00550537|Secondary|Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|The overall survival time is defined as the time from on treatment to death. Patients were censored of they were alive at the last follow up date. The median survival time and its confidence interval were estimated using Kaplan-meier method.|Through study completion, an average of 1 year|Total 116 participants. One patient was excluded due to death before any treatment.|||months||95% Confidence Interval|Median
1244243|NCT00550537|Secondary|Number of Patients With Worst-grade Toxicities Per Grade|"The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) – Cancer Therapy Evaluation Program (CTEP) [version 3.0 of December 2003] (Appendix B).~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Through study completion, an average of 1 year|116 paticipants, one patient was excluded due to death before any treatment. All patients who received erlotinib treatment and experienced an Adverse events.|||participants|||Number
1244244|NCT00550537|Secondary|Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B. For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date). The median survival time and 95% confidence interval were estimated using Kaplan-meier method.|Through study completion, an average of 1 year|Total 116 participants. One patient was excluded due to death before erlotinib treatment. Total 115 patients were included in the analysis.|||months||95% Confidence Interval|Median
1244245|NCT00550537|Secondary|Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. The response rate is calculated as the percentage of PR+CR among patients assessed for response.|Through study completion, an average of 1 year|Total 116 participants, 11 not assessed and 4 not evaluable. 101 assessed for response.|||percentage of patients assessed||95% Confidence Interval|Mean
1244246|NCT00550537|Secondary|Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
1244247|NCT00550537|Secondary|Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
1244248|NCT00550537|Secondary|Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment|End of treatment date|End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
1244249|NCT00550537|Secondary|Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
1244253|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB), Myocardial Infarction (MI)|Incidence of potentially clinically significant ECG abnormalities: Right bundle branch block (RBBB), Left bundle branch block (LBBB), myocardial infarction (MI)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244254|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: T Wave|Incidence of potentially clinically significant ECG abnormalities: T wave|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244255|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment|Incidence of potentially clinically significant ECG abnormalities: ST Segment|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244256|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec|Incidence of potentially clinically significant ECG abnormalities (QTcF increase 30-60 msec post-baseline)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244257|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcB Increase 30-60 Msec|Incidence of potentially clinically significant ECG abnormalities (QTcB increase 30-60 msec)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244258|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval|Incidence of potentially clinically significant ECG abnormalities involving QRS interval (change > 100 msec)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244259|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QT >500 Milliseconds (Msec)|Incidence of potentially clinically significant ECG abnormalities (QT>500 msec) post-baseline|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244260|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Magnesium|Incidence of potentially clinically significant magnesium levels post-baseline (normal range=1.2-2 mEq/L)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244261|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose|Incidence of potentially clinically significant glucose levels post-baseline (normal range=70-125 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244262|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol|Incidence of potentially clinically significant cholesterol levels post-baseline (normal range=0-199 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244263|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid|Incidence of potentially clinically significant uric acid levels post-baseline (normal range=4-8.5 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244264|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)|Incidence of potentially clinically significant BUN levels post-baseline (normal range=7-30 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244265|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Neutrophils|Incidence of potentially clinically significant neutrophil count post-baseline (normal range=1.8-8 thousands/microliter)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244266|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes|Incidence of potentially clinically significant lymphocyte count post-baseline (normal range = 16-46%)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244267|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)|Incidence of potentially clinically significant Activated Partial Thromboplastin Time (aPTT) levels post-baseline (normal range=22-34 seconds)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244268|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin|Incidence of clinically significant hemoglobin abnormalities post-baseline (normal range=11.8-16.8 g/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244269|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Body Temperature|Incidence of potentially clinically significant changes in body temperature post-baseline (defined as an increase of >=1.1 to >=38.3 degrees Celsius)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244270|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Body Weight|Incidence of clinically significant body weight change post-baseline (defined as change upward or downward of >=7%)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244271|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Pulse Rate|Incidence of abnormal pulse rate post-baseline [abnormal values: >=120 beats per minute (bpm) + increase of >=15 bpm; <=50 bpm + decrease of >=15 bpm]|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244272|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Blood Pressure|Incidence of abnormal systolic & diastolic blood pressure values post-baseline (abnormal systolic values: >=180 mmHg + increase of >=20 mmHg, <= 90 mmHg + decrease >=20 mmHg; abnormal diastolic values: >=105 mmHg+increase of >=15 mmHg, <=50 mmHg + decrease of >= 15 mmHg)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
1244274|NCT00550459|Secondary|Change From Baseline in Postural Stability Test|Change from baseline to Day 22 in Postural Stability Test Z-score (This test measures gross motor control. The ability to stand upright without moving is assessed using the SWAY meter that is modeled on the Wright Ataxiameter. A cord from the meter is attached to the subject who is required to stand as still as possible with feet apart and eyes closed for 1 minute. The test is then repeated with eyes open for 1 minute. The outcomes of these tests are combined and measured as a movement Z-score. Higher result=better postural stability); ITT population|baseline and Day 22|ITT population with LOCF (this group includes missing values)|||Z-score||Standard Deviation|Mean
1244275|NCT00550459|Secondary|Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)|Change from baseline to Day 22 in Gait Test (Timed Get-Up-and-Go Test=time it takes for a seated subject to rise from a chair, walk 3 meters, walk around an object and return to sit in chair. Values: under 10 sec (no difficulties), 10 to 20 sec (starting to have balance difficulty), over 30 sec (at high risk for falls and dependent in most activities of daily living and mobility); test assesses risk to elderly subjects of falling and higher scores in seconds indicate higher risk of falling; ITT population|baseline and Day 22|ITT population with OC|||Seconds||Standard Deviation|Mean
1244276|NCT00550459|Secondary|Change From Baseline in Overall Neurocognitive Composite Score|Change from Baseline to Day 22 in the overall Neurocognitive Composite Score (NCS)comprising the sum of 7 neurocognitive domain Z-scores (Reaction Time, Psychomotor Speed, Processing Speed, Continuity of Attention, Working Memory/Executive Functions, Quality of Episodic Verbal Memory, and Postural Stability); ITT population|baseline and Day 22|ITT population with OC|||Z-score||Standard Deviation|Mean
1244277|NCT00550459|Secondary|Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test|Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test; ITT population|baseline and Day 22|ITT population with OC|||Z-score||Standard Deviation|Mean
1244278|NCT00550459|Secondary|Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test|Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Psychomotor Speed (mean tap rate of Morse tapping test); ITT population|baseline and Day 22|ITT population with OC|||Z-score||Standard Deviation|Mean
1244279|NCT00550459|Secondary|Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests|Change from baseline in the individual neurocognitive domains Z-score for Reaction Time in Computer Tests (simple reaction time test, choice reaction time test, digit vigilance test); ITT population|baseline and Day 22|ITT population with OC|||Z-score||Standard Deviation|Mean
1244280|NCT00550459|Primary|Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)|"Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize yes 50 times;Choice=recognize yes or no 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right & left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data"|baseline and Day 22|Analysis based upon observed cases (OC).|||Z-score||Standard Deviation|Mean
1244281|NCT00550446|Other Pre-specified|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244282|NCT00550446|Other Pre-specified|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244291|NCT00550446|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244283|NCT00550446|Other Pre-specified|Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244284|NCT00550446|Other Pre-specified|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244285|NCT00550446|Other Pre-specified|Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24|The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1244286|NCT00550446|Other Pre-specified|Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers|The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||cells per micro liter (cells/mcL)||Standard Deviation|Mean
1244287|NCT00550446|Other Pre-specified|Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Standard Deviation|Mean
1244288|NCT00550446|Other Pre-specified|Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels|Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1244289|NCT00550446|Secondary|Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244290|NCT00550446|Secondary|Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1245564|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244292|NCT00550446|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244293|NCT00550446|Secondary|Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)|DAS28-3 (CRP) defined remission was classified as a score of <2.6.|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1244294|NCT00550446|Secondary|Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)|CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1244295|NCT00550446|Secondary|Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)|Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1244296|NCT00550446|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR [mm/hour] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244297|NCT00550446|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244298|NCT00550446|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244299|NCT00550446|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244345|NCT00550407|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2|||points on a scale||Standard Deviation|Mean
1244300|NCT00550446|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244301|NCT00550446|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1244302|NCT00550446|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
1244303|NCT00550446|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
1244304|NCT00550446|Secondary|Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1244305|NCT00550446|Secondary|Physician Global Assessment (PGA) of Arthritis|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1244306|NCT00550446|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1244307|NCT00550446|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1244308|NCT00550446|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1244309|NCT00550446|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1244310|NCT00550446|Secondary|Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Deviation|Mean
1244311|NCT00550446|Secondary|Swollen Joint Counts (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Deviation|Mean
1244312|NCT00550446|Secondary|Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Deviation|Mean
1244313|NCT00550446|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Deviation|Mean
1244314|NCT00550446|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 2, 4, 6, 8, 10, 12|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. Missing values were imputed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1244315|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: >= 90% improvement in TJC or SJC and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.|||percentage of participants|||Number
1244316|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.|||percentage of participants|||Number
1244317|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1244318|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: 20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1244424|NCT00549770|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|baseline, week 8|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||mmHg||Standard Error|Least Squares Mean
1244319|NCT00550446|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 % improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. The analysis used Baseline Observation Carried Forward (BOCF) imputation for missing values.|||percentage of participants|||Number
1244320|NCT00550420|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|HbA1c was evaluated as safety parameter in this study. The values of change from Baseline was presented. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was measured as the BW at specified visit minus the Baseline value.|Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82)|All subject population. Only those participants available at the indicated time points were analyzed.|||Percent HbA1c||Standard Deviation|Mean
1244321|NCT00550420|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE 4 Status at W24 and W52|The NPI assessed behavioural disturbances comprises 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety and aberrant motor activity. The participant caregiver asked about behaviour in the participant. If “Yes”, the informant then rates both the severity on a 3-point scale, 1: mild to 3: severe (total range: 0-36) and the frequency using a 4-point scale, 1: occasionally to 4: very frequently. The total domain score was frequency × severity. The distress was scored on 5-point scale, 0: no distress to 5 - very severe or extreme. A total NPI score was calculated by adding all domain scores together: NPI total score (from 0-144) and NPI distress score (from 0-60), with higher scores indicating more severe behavioral disturbance. Baseline was referred to Visit 1 (W0) assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.|Baseline (Visit 1, W0), W24 and W52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Score on scale||Standard Deviation|Mean
1244322|NCT00550420|Secondary|Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOEe 4 Status|The DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant’s ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) multiplied by 100. The DAD was conducted as an interview with the caregiver and took approximately 20 minutes. Baseline was referred to Visit 1 (W0) assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.|Baseline (Visit 1, W0), W24 and W52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1244323|NCT00550420|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE 4 Status at W24 and W52|The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale was completed by the investigator, based on the performance of the participant, and took approximately 5 to 10 minutes to administer. Change from parent Baseline in MMSE was analyzed using a mixed model for repeated measures (MMRM). Baseline was referred to Visit 1 (W0)assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.|Baseline (Visit 1, W0), W 24 and W52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1244324|NCT00550420|Secondary|Mean Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Score as a Function of APOE 4 Status|The CIBIC+ score used for global functioning assessment. The CIBIC+ assessment comprised of a 7-point rating of severity. It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; The lower score indicated betterment in functioning and higher score means greater dysfunction. The scale was based on interviews with the participant and the caregiver and was completed by an independent rater.|Baseline (Visit 1, W0), W 24 and W 52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1244325|NCT00550420|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale – Cognitive (ADAS-Cog) Total Score as a Function of Apolipoprotein E (APOE) 4 Status at W24 and W52|The 11-item ADAS-cog was used to assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline was referred to Visit 1 (W0)assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.|Baseline (Visit 1, W0), W24 and W52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1245565|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population||Week 52|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1244326|NCT00550420|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern|The clinical chemistry parameters including alanine amino transferase (ALT), aldolase, aspartate amino transferase (AST), blood urea nitrogen /creatinine (BUN/Creat) ratio, cholesterol (Chol), creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase (GGT), glucose, high density lipid (HDL), low density lipid (LDL), potassium, troponin 1, and urea were assessed as safety parameters. The number of participants with values outside the reference range (potential clinical concern ) at any time on treatment (ATOT) and follow-up period were reported. The treatment period was till W104 followed by 6 weeks of follow-up period till W110 of study.|Up to 82 weeks|All subject population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1244327|NCT00550420|Secondary|Number of Participants With Hematological Parameters of Potential Clinical Concern|The hematological parameters including eosinophils, lymphocytes, monocytes, platelet count, Segmented Neutrophils, total neutrophils, white blood cell (WBC), red blood cell (RBC) counts, hemoglobin, hematocrit count, mean corpuscle hemoglobin (MCH) and mean corpuscle volume (MCV) were analyzed as safety parameters. The number of participants with values outside the reference range (potential clinical concern ) at any time on treatment (ATOT) and follow-up period were reported. The treatment period was till W104 followed by 6 weeks of follow-up period till W110 of study.|Up to 82 weeks|All subject population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1244328|NCT00550420|Secondary|Change From Baseline in Non-fasting Measures of Lipid Metabolism Including Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein and Triglycerides at Indicated Timepoints.|Non-fasting measures of lipid metabolism including cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (TG) were measured at Baseline (W0), W4, W16, W36, W52, Year 2 W24 and Follow-up. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was calculated as the value at the indicated visit minus the Baseline value.|Baseline (Visit 1, W0), W4, W16, W36, W52, W76, and W82|All subject population. Only those participants available at the indicated time points were analyzed.|||Millimoles per litre||Standard Deviation|Mean
1244329|NCT00550420|Secondary|Number of Participants With Abnormal BW at Any Time During Treatment Period|BW of participants were recorded as vital sign at each visit. The BW were identified as of potential clinical concern if the vales were increased or decreased from Baseline by >=7%. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline in BW was measured as the BW value at specified visit minus the Baseline BW value. Number of participants with abnormal BW at any time during treatment period were reported.|Baseline (Visit 1, W0) to W 52|All subject population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1244330|NCT00550420|Secondary|Change From Baseline in Body Weight (BW)|BW of participants were recorded as vital sign at each visit. The BW were identified as of potential clinical concern if the vales were increased or decreased from Baseline by >=7%. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was measured as the BW at specified visit minus the Baseline value.|Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)|All subject population. Only those participants available at the indicated time points were analyzed.|||Kilograms (kg)||Standard Deviation|Mean
1244331|NCT00550420|Secondary|Number of Participants With Abnormal HR at Any Time During Treatment Period|HR of participants was recorded as vital sign at each visit. The HR values were identified as of potential clinical concern if the vales were out of the reference range 50 to 100 beats per minute (BPM) or meet a change from Baseline criterion. The change from Baseline criterion was as, increase in HR (high) from Baseline if HR was increased by >= 30 bpm or decrease in HR (Low) from Baseline if HR was decreased by >= 30 bpm from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the HR at specified visit minus the Baseline value. Number of participants with abnormal HR at any time during treatment period were reported.|Up to 82 weeks|All subject population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1244332|NCT00550420|Secondary|Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period|SBP and DBP of participant were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the vales were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from Baseline criterion. The change from Baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase form Baseline (high) if increased by >= 30 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.|Up to 82 weeks|All subjects population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1244333|NCT00550420|Secondary|Change From Baseline in Heart Rate (HR)|HR of participants was recorded as vital sign at each visit. The HR values were identified as of potential clinical concern if the vales were out of the reference range 50 to 100 beats per minute (BPM) or meet a change from Baseline criterion. The change from Baseline criterion was as, increase in HR (high) from Baseline if HR was increased by >= 30 bpm or decrease in HR (Low) from Baseline if HR was decreased by >= 30 bpm from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the HR at specified visit minus the Baseline value.|Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)|All subject population. Only those participants available at the indicated time points were analyzed.|||BPM||Standard Deviation|Mean
1244346|NCT00550407|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)|The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-S at Week 16/Withdrawal.|||points on a scale||Standard Deviation|Mean
1244334|NCT00550420|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP of participant were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the vales were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from Baseline criterion. The change from Baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase form Baseline (high) if increased by >= 30 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.|Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)|All subjects population. Only those participants available at the indicated time points were analyzed.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1244335|NCT00550420|Secondary|Percentage of Participants With AEs of Edema|Edema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. Percentage of participants reported with edema as AESI were reported.|Up to 82 Weeks|All subject population|||Percentage of participants|||Number
1244336|NCT00550420|Secondary|Number of Participants With Serious AEs and Deaths|A serious adverse event is defined as any untoward medical occurrence that, at any dose results in death, life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. The SAEs and deaths are reported from Visit 1 (W0) till end of the follow-up period (W110)|Up to Week 82|All subject population|||Participants|||Count of Participants
1244337|NCT00550420|Primary|Number of Participants With Any Adverse Events (AEs) and Severity of AEs|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The drug related-AEs of special interest (AESI) was reported. The severity of the AESI was categorized as mild, moderate and severe. Number of participants with AEs were reported for treatment duration of the study.|Up to Week 82|All subject population was comprised of all participants who took at least one dose of open-label study medication.|||Participants|||Count of Participants
1244338|NCT00550407|Post-Hoc|Number of Participants With Intervention for a Manic, Hypomanic, or Mixed Episode|The number of participants with intervention for a manic, hypomanic, or mixed episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for manic, hypomanic, or mixed episode (TIMan). Data from participants who had not met TIMan were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2|||participants|||Number
1244339|NCT00550407|Post-Hoc|Number of Participants With Intervention for Depressive Episode|The number of participants with intervention for depressive episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for depressive episode (TIDep). Data from participants who had not met TIDep were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2|||participants|||Number
1244340|NCT00550407|Post-Hoc|Number of Participants With Intervention for Any Mood Episode|The number of participants with intervention for any mood episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to intervention for any mood episode (TIME). See the outcome measure for TIME for data for the Placebo group. Data from participants who had not met TIME were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2|||participants|||Number
1244341|NCT00550407|Post-Hoc|Number of Participants With a Withdrawal Event|The number of participants who withdrew from the study was measured. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to study withdrawal. See the primary outcome measure for time to study withdrawal data for the Placebo group. Data from participants who had not withdrawn were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2|||participants|||Number
1244342|NCT00550407|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)|The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.|||points on a scale||Standard Deviation|Mean
1244343|NCT00550407|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)|The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2|||points on a scale||Standard Deviation|Mean
1244344|NCT00550407|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.|||points on a scale||Standard Deviation|Mean
1244362|NCT00550277|Secondary|To Evaluate the Toxicity of LBH589 in Patients With Refractory Advanced Clear Cell Renal Carcinoma||18 months|||||||
1244363|NCT00550277|Primary|To Evaluate the Efficacy of LBH589 in the Treatment of Patients With Refractory Clear Cell Carcinoma, as Measured by Progression-free Survival||18 months||||months||95% Confidence Interval|Median
1244347|NCT00550407|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)|The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2|||points on a scale||Standard Deviation|Mean
1244348|NCT00550407|Secondary|Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)|The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.|Week 16/Withdrawal|Full Analysis Set in the Preliminary Phase (FAS1): all participants who received at least one dose of study medication for the Preliminary Phase and underwent at least one efficacy assessment after receiving the study medication in the Preliminary Phase. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-I.|||points on a scale||Standard Deviation|Mean
1244349|NCT00550407|Secondary|Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)|The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.|Week 26/Withdrawal|FAS2|||points on a scale||Standard Deviation|Mean
1244350|NCT00550407|Secondary|Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)|"The TIMan was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of the relapse or recurrence of a manic, hypomanic, or mixed episode. No data are being presented for either treatment group. See the outcome measure entitled Number of Participants with Intervention for a Manic, Hypomanic, or Mixed Episode for data related to TIMan."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In both groups, the estimated median TIMan was not calculable because the probability of not reaching TIMan remained greater than 0.50 throughout the study.||||||
1244351|NCT00550407|Secondary|Time to Intervention for Depressive Episode (TIDep)|"The TIDep was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression episode. No data are being presented for either treatment group. See the outcome measure entitled Number of Participants with Intervention for Depressive Episode for data related to TIDep."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In the Lamotrigine 200 mg group, the estimated median TIDep was not calculable because the probability of not reaching TIDep remained greater than 0.50 throughout the study. The upper limit of the confidence interval was not calculable for the Placebo group due to an insufficient number of events.||||||
1244352|NCT00550407|Secondary|Time to Intervention for Any Mood Episode (TIME)|"The TIME was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or electroconvulsive therapy (ECT) determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression or the recurrence of a manic, hypomanic, or mixed episode, whichever occurred first. Categorization as a manic, hypomanic, or mixed episode was left to the Investigator's discretion. See the outcome measure entitled Number of Participants with Intervention for Any Mood Episode for data related to TIME."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In the Lamotrigine 200 mg group, the estimated median TIME was not calculable because the probability of not reaching TIME remained greater than 0.50 throughout the study.|||days||95% Confidence Interval|Median
1244353|NCT00550407|Primary|Time to Withdrawal From Study|"The time from randomization to the time at which the participant was withdrawn from the Double-Blind Phase of the study for any reason was measured. No data are reported for the Lamotrigine group because of an incalculable confidence interval. See the outcome measure entitled Number of Participants with a Withdrawal Event for data regarding the number of participants who withdrew from the study."|Randomization to Study Withdrawal (up to Week 26)|Full Analysis Set in Randomized (double-blind) Phase (FAS2): participants who received at least one dose of study medication in the Randomized Phase (RP) and had at least one post-treatment efficacy assessment in the RP. The upper limit of the confidence interval was not calculable for the Lamotrigine group due to an insufficient number of events.|||days||95% Confidence Interval|Median
1244354|NCT00550394|Primary|Percent Heavy Drinking Days|Change in percent heavy drinking days (number of days of > 4 drinks/day divided by number of days in that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)||||Percent heavy drinking days||Standard Deviation|Mean
1244355|NCT00550394|Primary|Percentage of Days Abstinent|Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)||||Percentage of days abstinent||Standard Deviation|Mean
1244356|NCT00550394|Primary|Drinks Per Drinking Day|Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period)|baseline to 12 weeks or endpoint (up to 11 weeks)||||Drinks per drinking day||Standard Deviation|Mean
1244357|NCT00550394|Primary|Drinks Per Day|Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)||||Drinks per day||Standard Deviation|Mean
1244358|NCT00550368|Secondary|Intensity of Gastrointestinal Symptoms|Composite gastrointestinal symptom score was on a scale from 0 (no symptoms) to 15 (severe symptoms). This composite was the sum of 5 self-reported, symptom scores, each ranging from 0 (none) to 3 (severe). The self-reported symptoms that subjects scored were: malaise, headache, nausea, vomiting, and loose stool.|48 hours||||units on a scale||Full Range|Median
1244359|NCT00550368|Primary|Development of Diarrhea||48 hours||||participants|||Number
1244360|NCT00550290|Primary|Wound Complications|Number of participants experiencing wound complications following vulvectomy. The presence of febrile episodes, elevated WBC counts and exam findings will be used to diagnose wound complications.|Two-week post-operative|All participants who received their assigned dose of each intervention and completed all study visits were included in the efficacy analysis.|||Participants|||Count of Participants
1244361|NCT00550277|Secondary|Overall Response||18 months|||||||
1244365|NCT00550173|Secondary|Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status|EGFR mutation status was defined as: participants with any mutations detected were categorized as mutated and participants without any mutations detected were categorized as non-mutated.|Randomization to date of PD or death up to 38 months|A subset of the Q-ITT Population who had EGFR samples; Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.|||participants|||Number
1244366|NCT00550173|Secondary|Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)|TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items).|Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months|A subset of the Q-ITT Population that included participants with LCSS results; Q-ITT Population: defined as all participants, with nonsquamous histology, who were randomized to therapy.|||months||95% Confidence Interval|Median
1244367|NCT00550173|Secondary|Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)|DCR was defined as the percentage of participants with CR, PR, or SD divided by the number of randomized and treated participants as assessed using the RECIST criteria. CR was defined as the disappearance of all target lesions; PR was defined as 1) at least a 30% decrease in sum of longest diameter of target lesions or 2) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions; SD was defined as small changes that did not meet the above criteria.|Randomization to disease progression up to 38 months|Q-ITT-TA Population: defined as all participants, with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.|||percentage of participants|||Number
1244368|NCT00550173|Secondary|Number of Participants With Adverse Events|A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module.|Randomization up to 39 months|Safety Population defined as non-squamous participants who received at least 1 dose of study therapy (pemetrexed plus erlotinib or pemetrexed or erlotinib). One participant was assigned to pemetrexed (single therapy) but received erlotinib (single therapy) at first cycle and this lead to the discrepancy of participants for the safety analysis.|||participants|||Number
1244369|NCT00550173|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death from any cause.|Baseline to date of death from any cause up to 45.5 months|Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy. Survival time was censored at the date of last contact for participants who were still alive or lost to follow-up, number of participants censored 35 (pemetrexed plus erlotinib), 44 (erlotinib) and 31 (pemetrexed).|||months||95% Confidence Interval|Median
1244370|NCT00550173|Secondary|Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]|TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.|Randomization to measured disease progression up to 38 months|Q-ITT Population - Tumor Analyzable (Q-ITT-TA) Population: defined as all participants with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.|||percentage of participants|||Number
1244371|NCT00550173|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.|Randomization to measured PD up to 38 months|Qualified Intent to Treat (Q-ITT) Population defined as all participants with nonsquamous histology, who were randomized to therapy.|||months||95% Confidence Interval|Median
1244372|NCT00550147|Secondary|Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)|The Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent:Inv) (Faries, Yalcin, Harder, & Heiligenstein, 2001) is an interviewer-administered semi structured interview with the parent, focusing on the 18 DSM-IV symptoms. Ratings are made on a 0 (never or rarely) to 3 (very often) scale. The range of the ADHDRS-IV is 0-54. A zero (0) scores indicates no ADHD symptoms and 54 indicates most severe ADHD symptoms. The ADHDRS-IV-Parent:Inv provides an overall severity score, symptom count, and ADHD diagnosis for the child.|See Arm/Group - repeated measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
1244373|NCT00550147|Secondary|Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale|The Swanson, Nolan and Pelham (SNAP-IV) is a 90-item, parent-completed questionnaire consisting of symptoms of ADHD, aggression, depression, and mania. Parents rate each item from 0(not at all) to 3 (very much) based on their child's behavior during the past week. The scores from the Oppositional-Defiant Disorder section of this questionnaire will be used as secondary efficacy measures of parent-reported aggressive behavior. These scores range from 0-24.|See arm/group - repeated measures analysis|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
1245566|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population||Week 26|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1244374|NCT00550147|Secondary|Modified Overt Aggression Scale (MOAS)|"The Modified Overt Aggression Scale (MOAS) is a clinician-rated scale of aggressive outbursts experienced in the past week. Weightings are assigned for severity and frequency of aggression. MOAS total severity score will be completed as a secondary efficacy measure of aggressive behavior. The range for the MOAS is 0-235. A score of 0 indicates no aggression and a score of 235 indicates the most severe and frequent aggressive outbursts."|See arm/group - repeated measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
1244375|NCT00550147|Secondary|CGI-S: Clinical Global Improvement Scale|"The CGI-S is a 1-7 investigator rating of overall severity of target behavioral symptoms, which will be completed at each visit as a secondary efficacy measure of global behavioral functioning. A score of 1 indicates normal, not ill at all and a score of 7 indicates among the most extremely ill patients."|See Arm/Group - Repeated Measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
1244376|NCT00550147|Primary|RAAPP: Rating of Aggression Against People and/or Property Scale|The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior).|See Arm/Group - Repeated Measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
1244377|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease|Subjects who achieved inactive disease based on DAS 28 CRP (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
1244378|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease|Subjects who achieved inactive disease based on the DAS 28 ESR (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
1244379|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 CRP Low Disease|Subjects who achieved low disease activity based on the DAS 28 CRP (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
1244380|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 ESR Low Disease|Subjects who achieved low disease activity based on the DAS 28 ESR (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
1244381|NCT00550043|Secondary|Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1244382|NCT00550043|Secondary|Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.|Baseline, Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1244383|NCT00550043|Secondary|The Percentage of Subjects Achieving ACR 70 Improvement|"The ACR 70 is defined as ≥ 70% improvement in tender joint count plus~≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: subject’s assessment of pain, PGA, PHGA, subject’s self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change."|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
1245567|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population||Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1244384|NCT00550043|Secondary|The Percentage of Subjects Achieving ACR 50 Improvement|The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: subject’s assessment of pain, PGA, PHGA, subject’s self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
1244385|NCT00550043|Primary|The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement|The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject’s assessment of pain, Subject’s global assessment of disease activity (PGA), Physician’s global assessment of disease activity (PHGA), subject’s self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.|Day 28|modified intent-to-treat (mITT) Population: subjects enrolled, took 1 dose of study drug, had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects discontinuing before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
1244386|NCT00549939|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.|52 weeks (double blind treatment period + open label extension treatment period)|The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received). It included 3 + 3 patients treated during the 1st treatment period only, 26 + 28 patients treated during the 2nd treatment period only and 54 + 55 patients treated during both periods.|||participants|||Number
1244387|NCT00549939|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|"When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.~A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism."|12 weeks (double blind treatment period)|The analysis was performed on the intent-to-treat (ITT) population. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.|||participants|||Number
1244388|NCT00549939|Secondary|Relative Change in Detrusor Compliance|Relative change = 100 * (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline|12 weeks (double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).|||percentage of mL/cmH2O||Standard Error|Least Squares Mean
1244389|NCT00549939|Secondary|Detrusor Compliance|"Detrusor compliance is defined as the relationship between change in detrusor volume and change in detrusor pressure.~It was calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δpdet) during that change in detrusor volume at leak point (C= ΔV/Δpdet)."|baseline and 12 weeks (double blind treatment period)|The analysis was performed on the intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post baseline detrusor compliance values. Patients were included in the treatment group to which they were allocated as per randomization.|||mL/cmH20||Standard Deviation|Mean
1244390|NCT00549939|Secondary|Relative Change in Detrusor LPP|Relative change = 100 * (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline|12 weeks (double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).|||percentage of cmH2O||Standard Error|Least Squares Mean
1244391|NCT00549939|Secondary|Absolute Change in Detrusor LPP|Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline|12 weeks ((double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).|||cmH2O||Standard Error|Least Squares Mean
1244392|NCT00549939|Secondary|Detrusor Leak Point Pressure (LPP)|Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.|baseline and 12 weeks (double blind treatment period)|The analysis was performed on the Intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post-baseline LPP values. Patients were included in the treatment group to which they were allocated as per randomization.|||cmH2O||Standard Deviation|Mean
1244393|NCT00549939|Primary|Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O|"Detrusor Leak Point Pressure (LPP) was measured by cystometry.~For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained.~Investigators reading was then consolidated by the review of all cystometry data by 2 external Expert Reviewers, who were blinded for the study treatment.~The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion)."|12 weeks (double blind treatment period)|The Intent-to-treat (ITT) population was used for the analysis. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.|||participants|||Number
1244394|NCT00549900|Primary|Number of Subjects Reporting Medically Significant Adverse Events|Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (up to Month7)||||Participants|||Count of Participants
1244474|NCT00549549|Secondary|Change From Baseline in Time Weighted Average of Patient’s Assessment of Pain Intensity Over 8, 12, and 24 Hours|Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity|Baseline, 8, 12, and 24 hours post first dose|ITT and LOCF|||Scores on a scale||Standard Deviation|Mean
1244395|NCT00549900|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters|"Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells.~Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below."|At Month 0 and Month 7|Analysis was performed on subjects from the Total vaccinated cohort that completed the study.|||Participants|||Count of Participants
1244396|NCT00549900|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days (Day 0-29) after any vaccination||||Participants|||Count of Participants
1244397|NCT00549900|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Day 0-6) period following each vaccination||||Participants|||Count of Participants
1244398|NCT00549900|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day (Day 0-6) period following each vaccination||||Participants|||Count of Participants
1244399|NCT00549900|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
1244400|NCT00549822|Secondary|Serum HER-2/Neu Levels and Serum/Plasma Angiogenic Mediators|Measurements for the serum HER-2/neu (human epidermal growth factor receptor 2) levels and serum/plasma angiogenic mediators|2 years|Study terminated prematurely due to slow accrual. Outcome measure data not available for analysis.||||||
1244401|NCT00549822|Secondary|Median Time to Disease Progression With Intermittent Letrozole.|The median time to disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors).|3 years||||Months||Full Range|Median
1244402|NCT00549822|Primary|Number of Patients With Decline in Serum CA 15-3 (Carcinoma Antigen 15-3)|The Number of patients that have have a response of a decrease in CA 15-3 or CA 27.29 levels by at least 50% of that individual patient’s baseline or peak level after re-introducing Letrozole therapy following a break in therapy as described in the intervention.|3 years||||Participants|||Count of Participants
1244403|NCT00549783|Secondary|Direct Costs for the United Kingdom|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom.|52 Weeks|Intent-to-treat, which consists of all patients in the United Kingdom who were randomized (started study) and received a baseline injection.|||British Pound (GBP)||Standard Deviation|Mean
1244404|NCT00549783|Secondary|Direct Costs for Sweden|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden.|52 Weeks|Intent-to-treat, which consists of all patients in Sweden who were randomized (started study) and received a baseline injection.|||Swedish Krona (SEK)||Standard Deviation|Mean
1244405|NCT00549783|Secondary|Direct Costs for Germany|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany.|52 Weeks|Intent-to-treat, which consists of all patients in Germany who were randomized (started study) and received a baseline injection.|||Euro (EUR)||Standard Deviation|Mean
1244406|NCT00549783|Secondary|Direct Costs for Canada|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada.|52 Weeks|Intent-to-treat, which consists of all patients in Canada who were randomized (started study) and received a baseline injection.|||Canadian dollar (CAD)||Standard Deviation|Mean
1244407|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 52|Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Scores on a Scale||Standard Deviation|Mean
1244408|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 24|Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Scores on a Scale||Standard Deviation|Mean
1244409|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 12|Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Scores on a Scale||Standard Deviation|Mean
1244555|NCT00549172|Secondary|Pain at Rest (VAS)|Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.|One year||||units on a scale||95% Confidence Interval|Mean
1244410|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
1244411|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
1244412|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
1244413|NCT00549783|Secondary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52|Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected|Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
1244414|NCT00549783|Secondary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12|Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
1244415|NCT00549783|Primary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24|Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
1244416|NCT00549770|Secondary|Percentage of Participants Who Achieved Successful Control in msSBP|Successful control in msSBP is defined as <140 mmHg.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||Percentage of participants|||Number
1244417|NCT00549770|Secondary|Percentage of Participants Who Achieved Successful Control in msDBP|Successful control in msDBP is defined as msDBP <90 mmHg.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||Percentage of participants|||Number
1244418|NCT00549770|Secondary|Percentage of Participants Who Achieved a Successful Response in msSBP|Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||Percentage of participants|||Number
1244419|NCT00549770|Secondary|Percentage of Participants Who Achieved a Successful Response in msDBP|Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||Percentage of participants|||Number
1244420|NCT00549770|Secondary|Change From Baseline in Nighttime maDBP and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am.|baseline, 8 weeks|Participants from the ABPM subset, who had both baseline nighttime and week 8 nighttime values, were included in the analysis only.|||mmHg||Standard Error|Least Squares Mean
1244421|NCT00549770|Secondary|Change From Baseline in Daytime maDBP and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm.|baseline, 8 weeks|Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.|||mmHg||Standard Error|Least Squares Mean
1244422|NCT00549770|Secondary|Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8.|baseline, 8 weeks|Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.|||mmHg||Standard Error|Least Squares Mean
1244425|NCT00549757|Other Pre-specified|Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)|AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).|||percentage of participants|||Number
1244426|NCT00549757|Other Pre-specified|Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)|"The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows:~Estimated GFR (mL/min/1.73 m^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black)~Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms."|Baseline to Month 3 and Month 6|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. At each visit (baseline, Month 3 and Month 6) , only patients with values at both baseline and post-baseline time point are included.|||mL/min/1.73 m^2||Standard Error|Least Squares Mean
1244427|NCT00549757|Other Pre-specified|Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)|"Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit.~Change from Baseline = Post - Baseline."|Baseline, Month 6 , last measurement (maximum at 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Last observation carried forward (LOCF) computation technique was used for month 6 data. At each visit, only patients with values at both baseline and this time point are included.|||mg/mmol||95% Confidence Interval|Geometric Mean
1244428|NCT00549757|Other Pre-specified|Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)|AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures|Time from randomization to the first event (Maximum 50 months)|Safety Set (SAF) - All patients who received at least one dose of trial medication. Patients were analyzed according to the treatment they received.|||percentage of participants|||Number
1244429|NCT00549757|Primary|Percentage of Participants With All Cause Mortality (Extension Phase)||from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
1244430|NCT00549757|Primary|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
1244431|NCT00549757|Primary|Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)|To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
1244432|NCT00549757|Primary|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)|ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)||||percentage of participants|||Number
1244433|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
1244434|NCT00549757|Primary|Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
1244435|NCT00549757|Primary|Percentage of Participants With Resuscitated Sudden Death (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
1244436|NCT00549757|Primary|Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)||from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
1244447|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244556|NCT00549172|Secondary|15-D (General Quality of Life -Assessment Tool)|The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).|One year||||units on a scale||95% Confidence Interval|Mean
1244437|NCT00549757|Primary|Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following composite primary endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
1244438|NCT00549757|Primary|Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244439|NCT00549757|Primary|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244440|NCT00549757|Primary|Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)|To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244441|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following secondary renal composite endpoint:~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).|||percentage of participants|||Number
1244442|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)"|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).|||percentage of participants|||Number
1244443|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)|"Occurrence was defined as the first event of the following secondary renal composite endpoint:~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244444|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)|"Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)"|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244445|NCT00549757|Primary|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)|ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244446|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244448|NCT00549757|Primary|Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)|Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244449|NCT00549757|Primary|Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244450|NCT00549757|Primary|Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)|"Occurrence was defined as the first event of the following composite primary endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
1244451|NCT00549718|Primary|Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1244452|NCT00549718|Secondary|CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 (‘normal’, not ill) to 7 (extremely ill).|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population.All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement,were in the efficacy analysis in the treatment group to which they were randomized.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1244453|NCT00549640|Secondary|The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.|The average composite nicotine withdrawal score (using Minnesota Nicotine Withdrawal Scale) change from baseline for the first 14 days following target quit date. Scale scores range from 0 (none) to 4 (severe).|baseline and 14 days|Analysis was restricted to subjects who had diary information available for the first 14 days following target quit date|||units on a scale||Standard Deviation|Mean
1244454|NCT00549640|Primary|Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study|Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of study (week 24) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)|6 months|Intention to treat (ITT). subject who discontinued study participation were counted as using tobacco.|||participants|||Number
1244455|NCT00549640|Primary|Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.|Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of the medication phase (week 8) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)|8 weeks|Intention to Treat. subjects with missing information were assumed to be using tobacco.|||participants|||Number
1244456|NCT00549601|Secondary|Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3|The Mini Mental State Examination (MMSE) was used to evaluate the patient's cognitive status and how it progressed over time. The 35-point version used in this study was made up of five sections: orientation, fixation, attention and calculation, memory and language, and constructional praxis. The total score for each patient was obtained by adding the score from each of the above sections. The individual receives 1 point for each correct answer. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline to Month 1 and Month 3|The Safety population was made up of all the randomized patients who had taken at least one dose of the study medication.|||Units on a scale||Standard Deviation|Mean
1244457|NCT00549601|Secondary|Overall Patient Satisfaction With Treatment|Patients were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 “Very good” - 5 “Very poor”) at the end of the study (Month 3). A higher score indicates less satisfaction.|At end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Participants|||Number
1244458|NCT00549601|Secondary|Overall Caregiver Satisfaction With Treatment|Caregivers were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 “Very good” – 5 “Very poor”) at the end of the study (Month 3). A higher score indicates less satisfaction.|At end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Participants|||Number
1244459|NCT00549601|Secondary|Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.|Adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). They were also tabulated by severity, relationship with study treatment, and action taken.|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Percentage of participants|||Number
1244460|NCT00549601|Secondary|Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)|Adverse events involving the skin included urticaria, pruritus, erythema, and pigmentation disorder. Only the groups administered rivastigmine transdermally via patch were analyzed. The adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Percentage of participants|||Number
1244461|NCT00549601|Primary|Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study|Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Percentage of participants|||Number
1244462|NCT00549562|Secondary|The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain|The VABS Maladaptive Behavior Domain measures undesirable behaviors that may interfere with an individual's adaptive functioning. The Maladaptive Domain consists two parts. Part I contains 27 minor maladaptive items and Part II contains 9 serious maladaptive behaviors. Each item is scored from 0 (never or seldom engages in the activity) to 2(usually or habitually engages in the activity). Part 1 yields a score of 0 to 54. Part II yields a score of 0 to 18. Both parts are combined to make a Total Score of 0 to 72. High scores of maladaptive behaviors reflect more negative behavior.|Week 8||||units on a scale||Standard Deviation|Mean
1244463|NCT00549562|Secondary|The Social Responsiveness Scale|The Social Responsiveness Scale (SRS) is a 65-item parent completed scale that assesses social awareness, social cognition, social communication, social motivation and autistic mannerisms. Each item is scored from 1 (not true) to 3 (almost always true). Interpretation in this study is based on a total score that is proportional to the level of impairment in reciprocal social behavior. Scores within 0-53 are within normal limits. Scores within 54-86 indicate mild to moderate impairment. Scores above 87 indicate severe impairment.|Week 8||||units on a scale||Standard Deviation|Mean
1244464|NCT00549562|Secondary|The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders|The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders (CY-BOCS-PDD) is semi-structured clinician rating scale designed to rate the current severity of repetitive behavior in children and adolescents with PDD. The scale consists of 5 items: Time Spent, Interference, Distress, Resistance and Control. Each item is scored from 0 (None) to 4 (Extreme). The scale yields a Total Score from 0 (least symptomatic) to 20 (most symptomatic). Higher scores indicate greater severity of repetitive behavior.|Week 8||||units on a scale||Standard Deviation|Mean
1244465|NCT00549562|Primary|The Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each item is rated from 0 (not at all to 3 (severe). The ABC has 5 subscales:Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe) and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe).|Week 8||||units on a scale||Standard Deviation|Mean
1244466|NCT00549562|Primary|The Clinical Global Impression-Improvement(CGI-I)|The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point.|Week 8||||units on a scale||Standard Deviation|Mean
1244467|NCT00549549|Secondary|Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events|The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.|Baseline to Day 14/Early Termination|ITT|||Participants|||Number
1244468|NCT00549549|Secondary|Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events|The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)|Baseline to Day 14/Early Termination|ITT|||Participants|||Number
1244469|NCT00549549|Secondary|Participants Global Evaluation of Study Medication Score|"The participant rated the study medication that they received during the study by completing the following question:~How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor"|Day 9|ITT|||Scores on a scale||Standard Deviation|Mean
1244470|NCT00549549|Secondary|Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy|Withdrawal due to lack of efficacy was assessed from Days 1 to 8|Day 1 to Day 8|ITT|||Participants|||Number
1244471|NCT00549549|Secondary|Percentage Change From Baseline in the Patient’s Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13|The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.|Baseline to Day 13|ITT, LOCF|||Percentage change||Standard Deviation|Mean
1244472|NCT00549549|Secondary|Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline|The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline|ITT, LOCF|||Units on a scale||Standard Deviation|Mean
1244475|NCT00549549|Secondary|Change From Baseline in Patient’s Assessment of Pain Intensity on Day 1|The patient’s assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).|Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Scores on a scale||Standard Deviation|Mean
1244476|NCT00549549|Secondary|Change From Baseline in Patient’s Assessment of Pain Intensity|The Patient’s assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline, Day 2 to Day 13|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Scores on a scale||Standard Deviation|Mean
1244477|NCT00549549|Secondary|Number of Participants With Warmth Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14|Warmth was assessed by the physician as present or absent.|Baseline, Day 5, Day 9 and Day 14|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Participants|||Number
1244478|NCT00549549|Secondary|Number of Participants With Redness Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination|Redness was assessed by the physician as present or absent.|Baseline, Day 5, Day 9 and Day 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Participants|||Number
1244479|NCT00549549|Secondary|Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling|Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)|Baseline, Days 5, 9 and 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Scores on a scale||Standard Deviation|Mean
1244480|NCT00549549|Secondary|Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness|Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).|Baseline, Day 5, Day 9, and Day 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Scores on a scale||Standard Deviation|Mean
1244481|NCT00549549|Primary|Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity|The Patient’s Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).|Baseline and Day 2|Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1244482|NCT00549445|Primary|Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin.|"Nasopharyngeal swabs were obtained to determine if there is a reduction in PGP levels (including both PGP & Neutrophil-PGP) after chronic treatment with azithromycin.~Unblinding of the parent trial revealed that there were 18 sputum samples from 13 placebo-treated participants and 14 sputum samples from 8 azithromycin-treated participants collected at months 1 through 12 of treatment (with sputum samples not being available, this greatly reduced the sample size)."|Baseline to 12 months|Levels of PGP from sputum samples are compared between subjects on the macrolide antibiotic, azithromycin, and subjects on placebo and correlated with neutrophil counts and protease activity in sputum.|||ng/mL||Full Range|Mean
1244483|NCT00549393|Other Pre-specified|Bacteremia|per protocol analysis of incidence of bacteremia comparing those in treatment and control groups|duration of ICU stay, median 3 days|Includes per protocol population of 1547 of 2422 in the treatment arm|||events per 1000 at-risk days||95% Confidence Interval|Number
1244484|NCT00549393|Secondary|Central Line Associated-bloodstream Infection (CLABSI)|Comparing incidence of central line-associated bloodstream infections between treatment and control groups|participants were followed for the duration of ICU stay, median stay 3 days||||events per 1000 at-risk days||95% Confidence Interval|Number
1244485|NCT00549393|Primary|Bacteremia|incidence of bacteremia comparing those in treatment and control groups|participants were followed for the duration of ICU stay, median stay 3 days|Intent to treat population|||events per 1000 at-risk days||95% Confidence Interval|Number
1244486|NCT00549328|Secondary|Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers|Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
1244487|NCT00549328|Secondary|Levels of Circulating Biomarkers in Plasma|Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
1244488|NCT00549328|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
1244489|NCT00549328|Secondary|Progression-Free Survival|Progression-free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause, whichever occurs first. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
1244574|NCT00548808|Secondary|Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks||16 weeks, 32 weeks, 48 weeks|Full Analysis Set: all randomized patients who received at least one dose of study drug.|||Units of insulin/kilogram/day (U/kg/day)||Standard Deviation|Mean
1244490|NCT00549328|Secondary|Number of Participants Who Had a Complete or Partial Response, or Stable Disease|Disease control was measured. Stable disease (SD) is defined as neither partial response (at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks) nor progressive disease (PD; a 20% increase in the sum of the longest diameters of target lesions, taken as a reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
1244491|NCT00549328|Primary|Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria|The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population: all participants who met inclusion criteria and willingly consented to participate in the study||||||
1244492|NCT00549302|Secondary|Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52|World Health Organization Functional Classification Assessment (WHO FC) is a method of classifying disease severity in PAH. The classes are: Class I: pulmonary hypertension (PH) but without resulting limitation of physical activity, Class II: PH resulting in slight limitation of physical activity, Class III: PH resulting in marked limitation of physical activity, Class IV: PH with inability to carry out any physical activity without symptoms. Deterioration of WHO FC is defined as moving to a higher WHO FC within one visit. Results are presented as Kaplan-Meier estimates (% probability) of remaining free from WHO FC deterioration after a given time.|Baseline and Weeks 16, 28, 40 and 52|Safety Population: all randomized participants who received at least 1 dose of study drug.|||probability (%) no PAH deterioration||95% Confidence Interval|Number
1244493|NCT00549302|Secondary|Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52|Borg dyspnea score is a participant rated measure of their greatest degree of shortness of breath during exertion (6-minute walk test). Score ranged from 0 (nothing at all) to 10 (very, very severe [maximal]).|Baseline and Weeks 16, 28, 40 and 52|All randomized participants who received at least 1 dose of study drug and who completed the Borg Dyspnea Assessment; LOCF|||units on a scale||Standard Deviation|Mean
1244494|NCT00549302|Secondary|6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52|6MWD measured the distance a participant was able to walk unassisted in 6 minutes.|Baseline and Weeks 16, 28, 40 and 52|All randomized participants who received at least 1 dose of study drug and who completed 6MWD test; Last Observation Carried Forward (LOCF)|||meters (m)||Standard Deviation|Mean
1244495|NCT00549302|Primary|Number of Participants With Adverse Events (AEs)|A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.|Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)|Safety Population: all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1244496|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.|||ug/L||95% Confidence Interval|Geometric Mean
1244497|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.|||ug/L||95% Confidence Interval|Geometric Mean
1244498|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.|||nanograms per Liter (ng/L)||95% Confidence Interval|Geometric Mean
1244499|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96|P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.|||micrograms per Liter (ug/L)||95% Confidence Interval|Geometric Mean
1244500|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.|||ratio||95% Confidence Interval|Geometric Mean
1244501|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.|||ratio||95% Confidence Interval|Geometric Mean
1244575|NCT00548808|Secondary|Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks||16 weeks, 32 weeks, 48 weeks|Full Analysis Set: all randomized patients who received at least one dose of study drug.|||Units of insulin per day (U/day)||Standard Deviation|Mean
1244502|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol).|Baseline, Week 96|Safety Population. Some participants had withdrawn by Week 96.|||ratio||95% Confidence Interval|Geometric Mean
1244503|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.|||ratio||95% Confidence Interval|Geometric Mean
1244504|NCT00549198|Secondary|"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"|Participants were asked at each visit whether or not they utilized unplanned healthcare resources.|Baseline to Week 96|ITT-E Population. The number of participants analyzed differed by visit because some had withdrawn during the study and some did not have an assessment performed.|||participants|||Number
1244505|NCT00549198|Secondary|Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96|Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24.|Week 96|On-Treatment Resistance: all participants who fulfilled the definition of protocol-defined virological failure (VF) who had paired baseline and VF genotypic data for analysis. One ABC/3TC participant took prohibited medication that potentially lowered efavirenz levels just prior to VF, allowing for the emergence of unexpected NRTI resistance.|||participants|||Number
1244506|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.|||cells/mm^3||Inter-Quartile Range|Median
1244507|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.|||cells/mm^3||Inter-Quartile Range|Median
1244508|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24.|||cells/millimeters cubed (mm^3)||Inter-Quartile Range|Median
1244509|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 96|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.|||participants|||Number
1244510|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 48|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.|||participants|||Number
1244511|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 24|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.|||participants|||Number
1244512|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy.|Week 96|Safety Population|||participants|||Number
1244513|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.|Week 48|Safety Population|||participants|||Number
1244514|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.|Week 24|Safety Population|||participants|||Number
1244515|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high.|Baseline, Week 96|Safety Population|||participants|||Number
1244516|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.|Baseline, Week 48|Safety Population|||participants|||Number
1244517|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.|Baseline, Week 24|Safety Population|||participants|||Number
1244518|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 96|Safety Population|||participants|||Number
1244519|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 48|Safety Population|||participants|||Number
1244520|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 24|Safety Population|||participants|||Number
1244521|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 96|Safety Population|||participants|||Number
1244522|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 48|Safety Population|||participants|||Number
1244523|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 24|Safety Population|||participants|||Number
1244524|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 96|Safety Population|||participants|||Number
1244525|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 48|Safety Population|||participants|||Number
1244526|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 24|Safety Population|||participants|||Number
1244527|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 96|Safety Population: all randomized participants who received at least one dose of study medication|||participants|||Number
1245568|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244528|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 48|Safety Population: all randomized participants who received at least one dose of study medication|||participants|||Number
1244529|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 24|Safety Population: all randomized participants who received at least one dose of study medication|||participants|||Number
1244530|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 96|ITT-E Population. Some participants had withdrawn by Week 96.|||participants|||Number
1244531|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 48|ITT-E Population. Some participants had withdrawn by Week 48.|||participants|||Number
1244532|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 24|ITT-E Population. Some participants had withdrawn by Week 24.|||participants|||Number
1244533|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.|||participants|||Number
1244534|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.|||participants|||Number
1244535|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.|||participants|||Number
1244536|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 96|ITT-E Population|||percent change||Standard Error|Mean
1244537|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 96|ITT-E Population|||percent change||Standard Error|Mean
1244538|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 48|ITT-E Population|||percent change||Standard Error|Mean
1244539|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 48|ITT-E Population|||percent change||Standard Error|Mean
1244540|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 24|ITT-E Population|||percent change||Standard Error|Mean
1244541|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24|BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 24|ITT-E Population|||percent change||Standard Error|Mean
1244605|NCT00548418|Secondary|Correlate Patterns of Gene Expression as Assessed by Microarrays||Correlative studies when specimens available|None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.||||||
1244542|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.|||participants|||Number
1244543|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.|||participants|||Number
1244544|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24.|||participants|||Number
1244545|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.|||participants|||Number
1244546|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.|||participants|||Number
1244547|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 24|ITT-E Population. Some participants had withdrawn from the study by Week 24.|||participants|||Number
1244548|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96|Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.|Baseline, Week 96|ITT-E Population|||mL/min||Standard Error|Mean
1244549|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48|Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.|Baseline, Week 48|ITT-E Population|||mL/min||Standard Error|Mean
1244550|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24|Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault.|Baseline, Week 24|ITT-E Population|||mL/min||Standard Error|Mean
1244551|NCT00549198|Secondary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96|Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine.|Baseline, Week 96|ITT-E Population|||mL/min/1.73m^2||Standard Error|Mean
1244552|NCT00549198|Secondary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24|Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine.|Baseline, Week 24|ITT-E Population|||mL/min/1.73m^2||Standard Error|Mean
1244553|NCT00549198|Primary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48|Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index.|Baseline, Week 48|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication|||milliliters per minute (mL/min)/1.73 m^2||Standard Error|Mean
1244554|NCT00549172|Secondary|Cost Effectiveness|Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.|1 and 2 years||2018-11-30|11/2018||||
1244557|NCT00549172|Primary|WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)|The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.|One year||||units on a scale||95% Confidence Interval|Mean
1244558|NCT00549172|Primary|Pain After Exercise (VAS)|Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.|One year||||units on a scale||95% Confidence Interval|Mean
1244559|NCT00549172|Primary|The Lysholm Knee Score|The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.|One year||||units on a scale||95% Confidence Interval|Mean
1244560|NCT00549055|Secondary|Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments|Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).|Months 3, 6, 9 and 12|FAS|||Participants|||Number
1244561|NCT00549055|Secondary|Frequency of Macugen Administration|Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant – 1)/ duration of treatment.|Baseline up to 28.4 months|FAS|||Weeks per injection||Standard Deviation|Mean
1244562|NCT00549055|Secondary|Duration of Treatment|Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).|Baseline up to 28.4 months|FAS|||Months||Standard Deviation|Mean
1244563|NCT00549055|Secondary|Number of Participants With Change in VA: Worsening|Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.|||Participants|||Number
1244564|NCT00549055|Secondary|Number of Participants With Change in VA: Stabilization|Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.|||Participants|||Number
1244565|NCT00549055|Secondary|Number of Participants With Change in VA: Improvement|Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.|||Participants|||Number
1244566|NCT00549055|Primary|Change From Baseline to Final Visit in Visual Acuity (VA) Score|Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.|Baseline, Month 24 or Early Termination|The Full Analysis Set (FAS) was derived from the set of all enrolled participants who were administered at least 1 injection of the study medication and had at least 1 post Baseline efficacy measurement. Participants analyzed refers to number of participants with analyzable data.|||Scores on scale||Standard Deviation|Mean
1244567|NCT00548886|Secondary|Determine Interobserver Variability When Measuring QT Intervals|Two pediatric electrophysiologists were given photocopies of rhythm strips obtained from the electrocardiograms and the electrophysiologists will then take four separate measurements of the QT interval from each rhythm strip. Interobserver variability was measured between the two electrophysiologists and their measurements on the same rhythm strip. False positive results will be based on measurement error.|During enrollment period|Interobserver variability was not performed due to study termination||||||
1244568|NCT00548886|Primary|Percentage of Subjects With a Positive Result in Absolute QT Interval|QT interval refers to the time interval on the standard electrocardiogram from the beginning of the QRS complex to the end of the T wave. Each participant had four QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint for an absolute QT interval. Lengthening of the absolute QT interval greater than 30 milliseconds on low dose epinephrine infusion would be considered a positive result.|35 minutes|Data not analyzed due to study termination||||||
1244569|NCT00548860|Primary|Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.|Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).|From Day 0 through 30 days after the last dose of study drug.||||participants|||Number
1244570|NCT00548847|Secondary|Overall Survival at 6 Months (Evaluate Overall Responses; Perform Lab Experiments to Test Hypothesis That Exposure to Interferon-alpha and GM-CSF Up-regulates Co-stimulatory Molecule Expression on Relapsed Acute Leukemia Cells)||6 months after cytokine treatment||||participants|||Number
1244571|NCT00548847|Primary|Efficacy of GM-CSF and Pegylated Interferon-alpha 2b When Administered to Patients With AML, ALL, Blast Phase CML, and MDS Relapse After Allogeneic Transplantation, Defined as Progression-free Survival of > 33% at 3 Months|Efficacy is defined as progression-free survival of > 33% at 3 months. This is based on our retrospective data on 10% 3 month survival for relapsed patients. Progression is defined an an increase in blasts in blood or marrow by 50% compared to baseline with at least 20% of all cells being blasts at the time of assessment.|3 months after cytokine treatment||||percentage of progression-free patients|||Number
1244572|NCT00548808|Secondary|Safety: Number of Participants With Serious and Non-Serious Adverse Events|Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.|baseline through 48 weeks|Full Analysis Set: all randomized participants who received at least one dose of study drug.|||participants|||Number
1244573|NCT00548808|Secondary|Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles||baseline, 48 weeks|Full Analysis Set: all randomized participants who received at least one dose of study drug and had baseline and endpoint values.|||millimoles/Liter (mmol/L)||Standard Error|Least Squares Mean
1244576|NCT00548808|Secondary|Change From Baseline in Postprandial Blood Glucose Over Time|The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.|Baseline, 16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.|||millimoles per liter||Standard Error|Least Squares Mean
1244577|NCT00548808|Secondary|7-point Self-monitored Blood Glucose Profiles||Baseline, 16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1244578|NCT00548808|Secondary|Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time||16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.|||percentage of participants|||Number
1244579|NCT00548808|Secondary|Change in Hemoglobin A1c (HbA1c) Over Time||Baseline, 16 Weeks, 32 Weeks, 48 Weeks|Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study.|||percent (%) glycated hemoglobin||Standard Error|Least Squares Mean
1244580|NCT00548808|Primary|Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 48 weeks|Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study. Last observation carried forward.|||percent (%) glycated hemoglobin||Standard Error|Least Squares Mean
1244581|NCT00548717|Secondary|Overall Survival||1 year||||percentage of participants|||Number
1244582|NCT00548717|Secondary|Incidence of Chronic GVHD|"Chronic GVHD will be graded according to the modified Seattle criteria. Chronic GVHD divided into limited and extensive and evaluated across the following systems: skin, cutaneous structures, liver, mouth, eyes, esophagus, intestines, lung, musculoskeletal, serous, nervous, urologic, vagina, hematopoietic, and immune.~Localized skin involvement with or without hepatic dysfunction is classified as limited disease.~Generalized skin involvement or limited disease plus eye involvement, oral involvement, hepatic dysfunction with abnormal liver histology, or involvement of any other target organ was classified as extensive disease.~Lee SJ, Vogelsang G, Flowers ME. Chronic graft‐versus‐host disease. Biol Blood Marrow Transplant.~2003;9:215‐33."|1 year||||percentage of participants|||Number
1244583|NCT00548717|Secondary|Incidence of 100 Day Mortality||100 days||||percentage of participants|||Number
1244584|NCT00548717|Secondary|To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence|This outcome measure was presented as a comparison between incidence of Grade 0-I aGVHD and Grade II-IV aGVHD across 5 time points (Weeks 1,2,3,8, and 12).|1 year|In the Siro/MMF group, the overall number of participants analyzed was 13, however, the number of participants with the MMF level data available varies at each time point. For the Siro/MMF/Bort group, no data were analyzed due to no data available for this Outcome Measure.|||ng/mL||Standard Deviation|Mean
1244585|NCT00548717|Secondary|The Rate of Renal Insufficiency|"Renal function will be measured weekly after transplant for 4 weeks, at 8 weeks and then at 3 month intervals from transplantation. Sentinel renal events such as the occurrence of thrombotic microangiopathy will be noted.~The rationale for the substitution of mycophenolate mofetil for tacrolimus is to continue to prevent acute GVHD, but minimize renal toxicity after transplantation. We will thus monitor renal toxicity closely in this study. In our previous experience, the rate of grade III‐V renal toxicity by day 100 after transplantation was about 10%. Here, grade III is defined as a creatinine level between 3.1 to 6 times the normal level, grade IV is defined as a creatinine level 6 times or more the normal level, and grade V is defined as a fatality due to renal toxicity."|1 year|One patient experienced grade 5 renal toxicity|||participants|||Number
1244586|NCT00548717|Secondary|Donor Stem Cell Engraftment, Including Donor-host Hematopoietic Chimerism Studies Post Transplant|Engraftment of donor cells by week 4 after transplantation. Assessment of donor stem cell engraftment will include donor-host hematopoietic chimerism analyses at 4 weeks and every 3 months after transplantation. Chimerism measured from peripheral blood or from bone marrow.|30 days||||participants|||Number
1244587|NCT00548717|Primary|To Determine the Rate of Grade II-IV Acute GVHD When Sirolimus and Mycophenolate Mofetil or Sirolimus, Mycophenolate Mofetil and Bortezomib is Used for GVHD Prophylaxis After Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies||150 days||||percentage of participants|||Number
1244588|NCT00548691|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAE's)||from Day 0 through 30 days after the last dose of study drug||||participants|||Number
1244589|NCT00548548|Secondary|Participants With Adverse Events|The intensity of Adverse Events (AEs) was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 on a five-point scale from Grade 1 (Mild) to Grade 5 (Death). A serious AE (SAE) was defined as any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|From randomization until 3 months after last dose (up to 26 months)|Safety population, including all patients randomized and exposed to study medication (defined as any one component of the combination). Patients are assigned to treatment groups based on the treatment they actually received.|||participants|||Number
1244590|NCT00548548|Secondary|Participants With Disease Control|Disease control for participants with measurable disease was defined as a complete response (CR), partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the RECIST criteria. For participants without measurable disease, disease control was defined as no disease progression for ≥ 6 weeks.|From randomization until the end of study, up to 26 months.|Intent-to-treat|||participants|||Number
1244604|NCT00548418|Secondary|Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies||When specimens available|None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.||||||
1244591|NCT00548548|Secondary|Duration of Response|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. Median duration of response was estimated using the Kaplan-Meier method.|From randomization to the end of study, up to 26 months|Participants with measurable disease at baseline who had a best overall response of complete response or partial response, and for whom duration of response data was available.|||months||95% Confidence Interval|Median
1244592|NCT00548548|Secondary|Participants With a Best Overall Response of Complete or Partial Response|Best overall response during first-line therapy is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response, as determined by the RECIST criteria. CR is defined as the disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions and no new or progression of non-target lesions, or the disappearance of all target lesions and persistence of one or more non-target lesion(s).|From randomization until the end of study, up to 26 months.|Measurable Disease Population, including all randomized participants with measurable disease (per RECIST) for gastric cancer at baseline. Patients were analyzed according to the treatment groups to which they were randomized.|||participants|||Number
1244593|NCT00548548|Secondary|Time to Disease Progression|Time to progression is defined as the time from randomization to the first occurrence of progressive disease (PD). PD was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Patients with no PD at study completion (including those who died before PD) were censored at the date of the last tumor assessment. Median time to PD was estimated using the Kaplan-Meier method.|From randomization until disease progression; assessed every 6 weeks for the first year and every 12 weeks thereafter, up to 26 months.|Intent-to-treat|||months||95% Confidence Interval|Median
1244594|NCT00548548|Secondary|Progression-free Survival During First-line Therapy|Progression-free survival (PFS) during first-line therapy is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first and only if it occurs no later than 28 days after last confirmed intake of any study medication and only if it occurs before the start of non-study antineoplastic treatment. Participants who did not progress or die in this interval or were lost to follow-up were censored at the date of the last tumor assessment within this time window. Median PFS was estimated using the Kaplan-Meier method.|From randomization until 28-days after the last study treatment was administered, up to 26 months.|Intent-to treat.|||months||95% Confidence Interval|Median
1244595|NCT00548548|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first. Patients who neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. Median PFS was estimated using the Kaplan-Meier method.|From randomization until disease progression or death, up to 26 months.|Intent to treat|||months||95% Confidence Interval|Median
1244596|NCT00548548|Primary|Overall Survival|The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method.|From randomization until death, up to 26 months|The Intent-to-Treat population, including all randomized participants.|||months||95% Confidence Interval|Median
1244597|NCT00548470|Secondary|Change From Baseline in Psychiatric Symptoms|The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology.|Baseline and 2 months later||||Units on the PANSS scale||Standard Deviation|Mean
1244598|NCT00548470|Secondary|RBANS Neuropsychological Battery|The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability.|baseline and month 2 of treatment||||RBANS scores||Standard Deviation|Mean
1244599|NCT00548470|Primary|Plasma Cotinine|cotinine level in plasma ng/ml.|baseline 1 month and 2 months||||ng/ml||Standard Deviation|Mean
1244600|NCT00548470|Primary|CO (Carbon Monoxide) Breathalyzer Level|Carbon Monoxide in breath ,parts per million|baseline and during 2 months of treatment||||ppm (carbon monoxide parts per million)||Standard Deviation|Mean
1244601|NCT00548470|Primary|Self Report of Smoking|Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.|Baseline and during 2 months of treatment||||Cigarettes||Standard Deviation|Mean
1244602|NCT00548431|Secondary|Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production|Biweekly bloodsamples during the 3 months are analyzed for 6TGN incorporation into leucocyte DNA. In addition Methylated Mercaptopurine (MeMP) and Erythrocyte-Methotrexate level is measured|During the 3 months consolidation therapy||2018-02-28|02/2018||||
1244603|NCT00548431|Primary|Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported|Number of participants following the protocol treatment for the full consolidation therapy with toxicity in this pilot study trying to individually titrate 6-mercaptopurine to the highest tolerable level during Consolidation.|3 months ( 79 days )||||Participants|||Number
1244606|NCT00548418|Secondary|Frequency of Response as Measured by RECIST Criteria (Imaging)|"RECIST criteria:~Complete response is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Progression is defined as ANY of the following - 20% increase in the sum of LD target lesions, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease, progression of existing non-target lesions~Stable disease is any condition not meeting the above criteria"|Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)|26 participants were evaluable for response.|||participants|||Number
1244607|NCT00548418|Secondary|Overall Survival|Defined as time from study entry until death from any cause or date of last contaqct.|Until death (follow-up ranged from 1.7 months to 33.4 months)||||months||90% Confidence Interval|Median
1244608|NCT00548418|Primary|Anti-tumor Activity as Measured by Surviving Progression-free|Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.|Progression-free survival at 6 months||||percentage of participants|||Number
1244609|NCT00548405|Secondary|Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2|Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline).|Baseline, Year 2|FAS population. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||percent change||Standard Deviation|Mean
1244610|NCT00548405|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2|MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.|Baseline, Year 2|FAS population. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||Z-score||Standard Deviation|Mean
1244611|NCT00548405|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.|Baseline, Year 2|FAS population. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||units on a scale||Standard Deviation|Mean
1244612|NCT00548405|Secondary|Percentage of Participants Who Were Relapse Free at Year 2|Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.|Year 2|FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||percentage of participants||95% Confidence Interval|Number
1244613|NCT00548405|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.|Up to 2 years|FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||relapses per participant per year||95% Confidence Interval|Number
1244614|NCT00548405|Primary|Percentage of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug as per initial randomization. Analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.|||percentage of participants||95% Confidence Interval|Number
1244629|NCT00548262|Secondary|Change From Baseline in Vital Signs: Weight|Weight measured as kilograms (kg).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with evaluable data.|||kg||Full Range|Median
1244630|NCT00548262|Secondary|Change From Baseline in Vital Signs: Supine Heart Rate|Supine heart rate measured as beats per minute (bpm).|Baseline to Week 2 Follow-up|Safety analysis population|||bpm||Full Range|Median
1244615|NCT00548340|Post-Hoc|Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)|Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 22 and 29. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 22 and 29.|Baseline, Night 22, and Night 29 measurements for WASO and TST|One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.|||minutes||Standard Error|Mean
1244616|NCT00548340|Post-Hoc|Average Change From Baseline - Latency to Persistent Sleep (LPS)|Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline, and the average of nights 22 and 29.|Baseline, Night 22, and Night 29 measurement|One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.|||minutes||Standard Error|Mean
1244617|NCT00548340|Secondary|Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)|Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.|Baseline, Night 1, and Night 8 measurements for WASO and TST|One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.|||minutes||Standard Error|Mean
1244618|NCT00548340|Primary|Average Change From Baseline - Latency to Persistent Sleep (LPS)|Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.|Baseline, Night 1, and Night 8 measurement|One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.|||minutes||Standard Error|Mean
1244619|NCT00548327|Other Pre-specified|Blood Plasma Concentration of Atomoxetine|Blood for drug plasma levels is obtained before and 3 hours after dosing on the 14th day receiving Atomoxetine.|before and 3 hours after dosing on the 14th day receiving Atomoxetine|Data were not collected for analysis because the study was terminated before target accrual||||||
1244620|NCT00548327|Secondary|Change in The Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a psychological questionnaire to rate the severity of anxiety.It contains 14 symptom-oriented questions.Each of these symptoms is given a severity rating, from not present(scored as 0)to very severe(scored as 4)|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual||||||
1244621|NCT00548327|Secondary|Change in The Profile of Mood States|The Profile of Mood States is an instrument that provides a rapid method of assessing transient, fluctuating mood states. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1)tension-anxiety, 2)depression-dejection, 3)anger-hostility, 4)fatigue-inertia, 5)vigor-activity and 6)Confusion-bewilderment.|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual||||||
1244622|NCT00548327|Primary|Changes in Cognitive Function Measured by Neuropsychological Testing|Neuropsychological testing consists of a battery of 10-12 individual tests to measure cognitive function. We expect both a drug effect and a genotype effect on neuropsychological tasks that measure dorsolateral prefrontal cortex (DLPFC) executive function, mostly in individuals who share the val/val genotype with respect to the met/met genotype.|2 hours after the first or the second dose of Atomoxetine or placebo on 14th day|Data were not collected for analysis because the study was terminated before target accrual||||||
1244623|NCT00548327|Secondary|Change in The Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) is a 7-point rating scale with (1) indicating the absence of a symptom or behavior and (7) indicating the most severe symptom. The PANSS includes three scales(Positive and Negative Syndromes and General Psychopathology)and five clusters (Anergia, Thought Disturbance, Activation, Paranoid/Belligerence and Depression.|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual||||||
1244624|NCT00548327|Primary|Changes in Functional Magnetic Resonance Imaging (fMRI) Blood-oxygen-level-dependent (Bold) Activity|"Main outcome measures were BOLD fMRI response (activation) while performing a prefrontal cortex-dependent task such as N-Back Working Memory with increasing levels of task difficulty. It was expected to have a greater level of activation in BOLD fMRI in schizophrenic patients with respect to normal volunteers, and a greater activation in individuals (either normal volunteers or patients) who share the val/val genotype with respect to the met/met genotype.~Based on prior fMRI studies and on power analysis of neuropsychological variables, at least 28 and 26 subjects are respectively needed to achieve significant power in functional neuroimaging and neuropsychological studies.These sizes provide an 80% power to observe significant differences between drug conditions at the 0.05 level."|2 hours after the first or the second dose of Atomoxetine or placebo on 14th day|Data were not collected for analysis because the study was terminated before target accrual||||||
1244625|NCT00548262|Secondary|Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)|Chemistry laboratory test data measured as international units per (IU/L).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.|||IU/L||Full Range|Median
1244626|NCT00548262|Secondary|Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)|Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.|||mg/dL||Full Range|Median
1244627|NCT00548262|Secondary|Change From Baseline in Vital Signs: Respiration Rate|Respiration rate measured as respirations per minute (resp/min).|Baseline to Week 2 Follow-up|Safety analysis population|||resp/min||Full Range|Median
1244628|NCT00548262|Secondary|Change From Baseline in Vital Signs: Temperature|Temperature measured as degrees of Celsius (C).|Baseline to Week 2 Follow-up|Safety analysis population|||Degrees of Celsius||Full Range|Median
1244632|NCT00548262|Secondary|Length of Stay in Intensive Care Unit (ICU)|Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.|Baseline up to Week 6 Follow-up|MITT; N=number of participants evaluable for length of time in ICU.|||Days||95% Confidence Interval|Median
1244633|NCT00548262|Secondary|Length of Hospital Stay|Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.|Baseline to Week 6 Follow-up|MITT; data not summarized using descriptive statistics.|||days|||Number
1244634|NCT00548262|Secondary|Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment|Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.|Baseline to Day 42|Safety analysis set: all participants who received any dose of study medication.|||days||Full Range|Median
1244635|NCT00548262|Secondary|Time to Negative Blood, Specimen, or Tissue Culture|Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).|Baseline to Week 2 Follow-up|MITT; data not summarized using descriptive statistics.|||Days|||Number
1244636|NCT00548262|Secondary|Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis|"Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded disease under study as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone."|Baseline to Week 6 Follow-up|MITT. MITT. Death for 1 participant reported twice in this study(recorded at End of Treatment and at End of Study); both instances are reported in this table under Attributal Death=No.|||participants|||Number
1244637|NCT00548262|Secondary|Number of Participants Per Survival Status (Alive or Dead) on Day 30||Day 30|MITT|||participants|||Number
1244638|NCT00548262|Secondary|Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.|EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.|||participants|||Number
1244639|NCT00548262|Secondary|Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|Baseline, Week 2 Follow-up (F/U)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data insufficient for analysis by status=elderly >65 years of age; not summarized.|||participants|||Number
1244640|NCT00548262|Secondary|Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|EIVT (up to Day 42)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly >65 years of age; not summarized.|||participants|||Number
1244641|NCT00548262|Secondary|Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|Baseline, EOT (up to Day 42)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly (>65 years of age); not summarized.|||participants|||Number
1244642|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, Week 2 Follow-up|MITT. Missing or indeterminate set to Failure; CI was not calculated for status of Failure.|||participants|||Number
1245569|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population||Week 104|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244643|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, EOT (up to Day 42)|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.|||participants|||Number
1244644|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, EIVT (up to Day 42)|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.|||participants|||Number
1244645|NCT00548262|Secondary|Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)|Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).|End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up|MITT. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for Failure.|||participants|||Number
1244646|NCT00548262|Primary|Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment|Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).|End of Treatment (EOT) (up to Day 42)|Modified Intent-to-Treat population (MITT): all Intent-to-Treat (ITT) participants (took at least 1 dose of study treatment) and with a positive baseline culture for a Candida spp within 96 hours before entry into the study. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure.|||participants|||Number
1244647|NCT00548249|Secondary|Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.||two separate sessions measured one week apart.|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication|||Subjects|||Number
1244648|NCT00548249|Secondary|Estimate the Amount of SFP Transferred From the Dialysate to the Blood During a Dialysis Session.||At each dialysis session for up to 26 weeks|||||||
1244649|NCT00548249|Secondary|Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.||At each dialysis session for up to 26 weeks||||Subjects|||Number
1244650|NCT00548249|Secondary|Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.|Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks).|Every 4 weeks|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication|||pg||Standard Deviation|Mean
1244651|NCT00548249|Secondary|Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.|Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL|Up to 26 weeks|"Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication.~Because of the small number of patients reaching the endpoint of decrease in Hgb >= 1.0 g/dL, the Kaplan-Meier analysis could not estimate the number of days for at least one treatment group for the 50th percentile and higher."|||Days|||Number
1244652|NCT00548249|Secondary|Change From Baseline in Hemoglobin (Hgb)||two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication|||grams/ deciliter (g/dL)||Standard Deviation|Mean
1244653|NCT00548249|Primary|Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.|Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).|up to 26 weeks|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication|||Percent of subjects|||Number
1244654|NCT00548197|Secondary|Anatomic Status of the Retina|Number of Participants with Postoperative Vitreous Hemorrhage|Last follow up, an average of 7 months post-operation|Postoperative Vitreous Hemorrhage|||Participants|||Count of Participants
1244655|NCT00548197|Primary|Best Corrected Visual Acuity|Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)|last follow up, an average of 7 months post-operation||||LogMar||Standard Deviation|Mean
1244656|NCT00548184|Secondary|Data Analysis of the Biomarkers: Immunohistochemical Staining of Cells From Breast Biopsies and Skin Biopsies Will be Performed.||one year|||||||
1244657|NCT00548184|Primary|Pathologic Assessment After Study Treatment|Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.|12 weeks|65 patients were enrolled and received the study treatment. 1 patient was found ineligible for this study therefore she was excluded from outcome report.|||participants|||Number
1244658|NCT00548145|Secondary|MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)|Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)|baseline and 12 months|||||||
1244659|NCT00548145|Primary|Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)|Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.|baseline and 12 months||||scores on a scale||Standard Deviation|Mean
1244660|NCT00548132|Secondary|Clinical Sepsis Episodes/Per 1000 Catheter Days|This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.|2 years||||sepsis episodes/1000 catheter days|||Number
1244661|NCT00548132|Primary|The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms|The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization|2 years|Based on previous data (unpublished),there would be a 60% reduction in the incidence of bloodstream infections-- the primary outcome. The number of patients included in this study had a large enough sample size to show a statistical difference.|||BSIs /1000 catheter days|||Number
1244662|NCT00548041|Primary|Feasibility of Rapid HIV Testing in Emergency Department|Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.|2 years||||participants|||Number
1244663|NCT00547911|Secondary|Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Heart rate was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||BPM||Standard Error|Mean
1244664|NCT00547911|Secondary|Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Diastolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||mmHg||Standard Error|Mean
1244665|NCT00547911|Secondary|Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Systolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||mmHg||Standard Error|Mean
1244666|NCT00547911|Primary|Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma dihydroxyphenylglycol (DHPG) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||nmol/L||Standard Error|Mean
1244667|NCT00547911|Primary|Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxymandelic acid (DHMA) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||nmol/L||Standard Error|Mean
1244668|NCT00547911|Primary|Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma norepinephrine concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||nmol/L||Standard Error|Mean
1244669|NCT00547911|Primary|Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxidopa (LDOPS) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||nmol/L||Standard Error|Mean
1244670|NCT00547703|Secondary|Side Effects|To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia. Patients were asked about side effects on each office visit and ask to call for significant side effects.|8 weeks|||||||
1244671|NCT00547703|Secondary|QOLRAD Questionaire for Patients With Upper Abdominal Symptoms|Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia|8 weeks|||||||
1245570|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244672|NCT00547703|Primary|Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.|Patient would answer yes or no to a simple question asking whether they had adequate relief of abdominal pain or discomfort. This was measured at weeks 2,4 and 8 of the study but only week 8 was reported. What is being reported is the number of participants who answered yes.|8 weeks|All patients who completed the 8 weeks of the study|||participants|||Number
1244673|NCT00547638|Other Pre-specified|Incidence of Any Other Anticipated or Unanticipated Adverse Events|Adverse events were coded using the MedDRA dictionary. In addition severity, relationship to treatment and procedure, action taken and outcome were described. Adverse events were summarized by treatment group. No formal statistical analysis was performed on overall incidence of adverse events with the exception of clinical infection, acute inflammatory reactions and skin blistering.|Day 30|Intent to treat population in which subjects experiencing at least 1 adverse event were reported and analyzed.|||Participants Experiencing at least 1 AE|||Number
1244674|NCT00547638|Other Pre-specified|Incidence of Skin Blistering at Day 14|The incidence of skin blistering is presented as a tabulation of the presence or absence of skin blistering by treatment group. A formal statistical analysis of the incidence of blistering at Day 14 was performed using the Fisher's Exact Test.|Day 14|Intent to treatment population was analyzed for the incidence of skin blistering at Day 14.|||Participants With Blistering at Day 14|||Number
1244675|NCT00547638|Other Pre-specified|The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30|Each parameter (edema, erythema, pain and location temperature) is measured on a 4 point scale (0, 1, 2, 3). The individual values are added to generate an overall AIRE Score. AIRE Scores were summarized as good (score=0) versus poor (score>0) by treatment group and compared for differences using the Fisher's Exact Test.|At Day 14 and Day 30|Intent to treat population was analyzed for subjects in each group with Total AIRE Score of 1-12 at Day 14 and Day 30. Analysis is performed on the proportion of subjects in each group with Total AIRE Scores greater than 0 versus those less or equal to 0 at each timepoint.|||Participants With AIRE Score >0|||Number
1244676|NCT00547638|Other Pre-specified|The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30|Incidence of clinical infection (defined by observation of redness, swelling, purulent discharge, pain, increased skin temperature, fever or other systemic signs of injection) collected at the Day 14 and Day 30 visits. A formal statistical analysing using Fisher's Exact Test was performed.|Through Day 30|Intent to treat population was analyzed for the presence of signs of infection at Day 14 and Day 30.|||Participants|||Number
1244677|NCT00547638|Secondary|Cosmesis|The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms.|30 days (±5 days)|Intent to Treat Population where good outcome for overall appearance. A p-value of 0.457 was determined following comparison by Fisher's Exact Test.|||Participants|||Number
1244678|NCT00547638|Primary|The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.|Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.|14 days (±2 days)|Intent to treat population results are presented.With respect to Measure Description it is defined as the number of participants in each group with successful wound-closure (approximation).|||Participants|||Number
1244679|NCT00547534|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.|Two years||||Lymphoma Subjects|||Number
1244680|NCT00547534|Secondary|Toxicity of Drug Combination in the Subjects||Two years||||Lymphoma Subjects|||Number
1244681|NCT00547534|Primary|Number of Participants With Progression Free Survival at 2 Years|To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.|Two years|Analysis was per protocol.|||Participants|||Number
1244682|NCT00547521|Secondary|Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE period, were evaluated. n=number of participants evaluated.|||participants|||Number
1244683|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study|Sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or <LLN); glucose (serum): <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx).|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE study, were summarized. n=number of participants evaluated.|||participants|||Number
1244684|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT), Blood Urea Nitrogen (BUN) and Creatinine MA criteria: ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx; creatinine: >1.5 * pre-Rx.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and with specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.|||participants|||Number
1244685|NCT00547521|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.|||participants|||Number
1244686|NCT00547521|Secondary|Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE Study, were evaluated.|||participants|||Number
1244687|NCT00547521|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs/SAEs are those events with a relationship to the study therapy of certain; probable; possible; or missing.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE period, were evaluated. Includes all deaths reported during the LTE including those that occurred greater than 56 days after the last dose.|||participants|||Number
1244688|NCT00547521|Secondary|Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup|Remission was defined as DAS 28-CRP < 2.6 and LDA was defined as DAS 28-CRP <= 3.2. End of ST Study was Day 113. Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.|Day 113, Day 1345|Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies, and who had values at Day 113 and Day 1345, were evaluated.|||participants|||Number
1244689|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup consisted of participants who received SC abatacept and did not receive MTX in the ST and LTE Studies. DAS28-CRP: continuous variable which is a composite of 4 variables:number of tender joints out of 28, number of swollen joints out of 28, C-reactive protein (CRP) in mg/L and self assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. HAQ-DI includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score sums worst scores in each domain and divides by the number of domains answered. Baseline was Day 1 of Short Term Study. Day 113 was the last day of the Short Term Study.|Baseline, Day 113, Day 1345|Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies and who had values at Baseline, Day 113, and Day 1345, were evaluated.|||units on a scale||Standard Error|Mean
1244690|NCT00547521|Secondary|Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study|RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result).|Continuously from start of LTE period up to 7 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE and who had an RF test result up to 7 days post the last dose of abatacept in the LTE study, were evaluated.|||participants|||Number
1244691|NCT00547521|Secondary|Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy|HAQ response was defined as an improvement of at least 0.3 units from baseline in the HAQ Disability Index (HAQ DI). Baseline was Day 1 of the ST Study and Day 113 was the last day of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.|||participants|||Number
1245571|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population||Week 52|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244692|NCT00547521|Secondary|Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. Baseline was Day 1 in the ST Study and Day 113 was the last day of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.|||units on a scale||95% Confidence Interval|Mean
1244693|NCT00547521|Secondary|Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE|DAS28-CRP remission was defined as DAS28-CRP less than 2.6 and LDA was defined as DAS28-CRP less than, equal to 3.2. End of ST Study was Day 113.|Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Day 113 and Day 1345, were evaluated.|||participants|||Number
1244694|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study|A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. Baseline was Day 1 of the ST Study. Day 113 was the end of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE Study and who had values at Baseline, Day 113 and Day 1345, were evaluated.|||participants|||Number
1244695|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study|DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. Baseline was Day 1 of the ST Study; Day 113 was the end of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE Study and who had DAS28-CRP values at Baseline, Day 113 and Day 1345, were evaluated.|||Units on a scale||95% Confidence Interval|Mean
1244696|NCT00547521|Secondary|Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study|The Meso-Scale Discovery (MSD) electrochemiluminescence (ECL) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10. Antibody responses included CTLA4 and possibly immune globulin (IG), IG and/or junction region.|Days 197, 281, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, 1821, 1989, days post dose: 28, 56, 85, 168|Participants who received at least 1 dose of abatacept in the LTE Study and who had values at each specified timepoint, were evaluated.|||participants|||Number
1244697|NCT00547521|Secondary|Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study|Cmin serum abatacept concentration was obtained directly from the concentration-time data.|Days 1, 15, 29, 43, 57, 85 and 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period. n=those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||microgram/mL||Full Range|Geometric Mean
1244698|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Vital Signs During the ST Study|Vital signs measurements (including seated blood pressure, heart rate and temperature) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs/physical examination were clinically meaningful.|At screening and on days 1,15,29,43, 57, 85 and 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
1244699|NCT00547521|Secondary|Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study|Anti-dsDNA antibody status was categorized as negative or positive based upon assay-specific numeric cut-off values.|Day 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
1244700|NCT00547521|Secondary|Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study|ANA status was categorized as negative or positive corresponding to the following dilutions: less than 1:160 and greater than equal to 1:160.|Day 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
1244701|NCT00547521|Secondary|Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.|||participants|||Number
1244833|NCT00546754|Secondary|Time to Achieve Target Blood Pressure|Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)|12 weeks|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 406 and 360 patients for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||Days||Standard Deviation|Mean
1244702|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or < LLN); glucose (serum): <65 mg/dL or >220 mg/dL.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.|||participants|||Number
1244703|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total)|MAs= laboratory measurements marked as abnormal: creatinine: >1.5 * pre-Rx; sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN).|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
1244704|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
1244705|NCT00547521|Secondary|Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept)in the ST period.|||participants|||Number
1244706|NCT00547521|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
1244707|NCT00547521|Secondary|Number of Participants With AEs of Special Interest During the ST Study|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.|Continuously through ST period (up to Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.|||participants|||Number
1244708|NCT00547521|Secondary|Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy.|Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.|||participants|||Number
1244775|NCT00546897|Secondary|Morphologic Leukemia Free State|Morphologic leukemia-free state: Defined as < 5% blasts on the BM aspirate with spicules and a count of > 200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
1244709|NCT00547521|Secondary|Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs or SAEs were recorded.|Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.|||participants|||Number
1244710|NCT00547521|Secondary|Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study|RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result). Cross-tabulation of frequency of seroconversion of RF at Day 113 with baseline, in the ST period, was provided.|Baseline and Day 113.|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period.|||participants|||Number
1244711|NCT00547521|Secondary|Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.|Baseline and Month 4 (Day113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period. n is the number of participants with baseline and post-baseline values.|||Units on a scale||95% Confidence Interval|Mean
1244712|NCT00547521|Secondary|Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.|Baseline and Month 4 (Day 113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.|||Units on a scale||95% Confidence Interval|Mean
1244713|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study|A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline.|Day 113.|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.|||participants|||Number
1244714|NCT00547521|Primary|Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for MSD Results)|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum . It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL(MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Baseline and day 15, 29, 43, 57, 85 and 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.||||||
1244715|NCT00547521|Primary|Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for ELISA Results)|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Baseline and on day 15, 29, 43, 57, 85 and 113|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.||||||
1244716|NCT00547521|Primary|Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results)|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Day 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive IMG samples on Day 113, therefore this analysis was not necessary.||||||
1244816|NCT00546871|Secondary|Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g/L||95% Confidence Interval|Median
1244717|NCT00547521|Primary|Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results)|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive Immunoglobulin G (IMG) samples on Day 113, therefore this analysis was not necessary.||||||
1244718|NCT00547521|Primary|Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n=number of participants who were evaluated for this measure at each timepoint, for each group respectively.|||participants|||Number
1244719|NCT00547521|Primary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 15, 29, 43, 57, 85,113 and 28, 56, and 85 days post last dose.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n = those participants who were evaluated for this measure at each timepoint, for each group respectively.|||participants|||Number
1244720|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study|DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96.|Baseline and Month 4 (Day113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.|||Units on a scale||95% Confidence Interval|Mean
1244721|NCT00547521|Primary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 113|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.|||participants|||Number
1244722|NCT00547456|Primary|Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.||4 weeks|The assay used did not work, as a result, no data for any Outcome Measures was collected. The trial is closed and completed.||||||
1244723|NCT00547378|Secondary|All Implanted Cohort: Infection Rate Associated With the Tined Lead|To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.|5 years|This objective was analyzed in the all implanted cohort.|||Cumulative probability at 5 years||95% Confidence Interval|Number
1244724|NCT00547378|Secondary|All Implanted Cohort: Tined Lead Migration Rate|To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. Suspected tined lead migration resulting in an adverse event of lead migration/dislodgement meets the definition of this endpoint.|5 years|This objective was analyzed in the all implanted cohort.|||Cumulative probability at 5 years||95% Confidence Interval|Number
1244725|NCT00547378|Primary|All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery|"To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33.~Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest."|5 years|This objective was analyzed in the all implanted cohort.|||Cumulative probability at 5 years||95% Confidence Interval|Number
1244726|NCT00547378|Primary|Randomized Cohort: OAB Therapeutic Response|"To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as:~at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or~at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (<8 voids/day) for subjects with urgency-frequency at baseline."|6 months|Intent-to-Treat (ITT): an analysis that includes all randomized subjects. This was analysis in the randomized cohort.|||percentage of participants with response|||Number
1244995|NCT00546052|Other Pre-specified|Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments|Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks – HDL-C 52 Baseline) / (HDL-C Baseline)].|52 Weeks - Baseline|Per Protocol|||Percent Change||Standard Deviation|Mean
1244727|NCT00547365|Primary|Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)|Positive clinical response was defined by improvement in heart function in participating patients with cardiac-dominant AL amyloidosis, as demonstrated by increased serum anti-fibril immunoglobulin G (IgG) antibody levels and reduction (or no evident progression) in amyloid burden.|Up to 1 year|Two of ten patients with AL cardiac involvement who received IGIV infusions were analyzed (other eight individuals were removed from study before completion due to death/conditions unrelated to IGIV, loss to follow-up, or physician decision).|||participants with positive response|||Number
1244728|NCT00547365|Primary|Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One Infusion of IGIV.||Up to 1 year|All patients who had at least one infusion of human immune globulin intravenous.|||events|||Number
1244729|NCT00547157|Secondary|CRR by 6 Months - Central|CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.|From randomization till 6 months|Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.|||Proportion of Participants||95% Confidence Interval|Number
1244730|NCT00547157|Secondary|ORR by 6 Months - Central|ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.|From randomization to 6 months|Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.|||Proporation of Participants||95% Confidence Interval|Number
1244731|NCT00547157|Secondary|Overall Survival|Time from first dose date to death|maximum follow up time 46.2 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
1244732|NCT00547157|Secondary|Progression-free Survival|Time from first dose date till disease progression or death|maximum follow up time 46.2 months|Efficacy analysis set|||months||95% Confidence Interval|Median
1244733|NCT00547157|Secondary|Duration of Local Regional Control|Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)|maximum follow up time 46.2 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
1244734|NCT00547157|Primary|Local Regional Control Rate at 2 Years|Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator’s assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports).|from study day 1 to 2 years|Efficacy Analysis Set|||Proportion of Participants||95% Confidence Interval|Number
1244735|NCT00547118|Secondary|Calgary Depression Scale (CDS) Total Score|"The CDS total score is the addition of scores from items 1-9. Each item's scores range on a scale of 0=Absent to 3=Severe. The total score range is from 0-27. Higher total scores indicate a more severe depression rating."|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244736|NCT00547118|Secondary|Clinical Global Impression (CGI)|The global improvement score can range from 1-7, with higher scores indicating worse total improvement clinically.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244737|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) - Avolition|SANS Avolition score. Scores can range from 0-5, with higher scores indicating more severe avolition.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244738|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) - Alogia|SANS Global Rating of Alogia. Scores can range from 0-5, with higher scores indicating more severe alogia.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244739|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) - Blunted Affect|SANS Global Rating of Affective Flattening. Scores can range from 0-5, with higher scores indicating more severe blunted affect.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244740|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) - Anhedonia|SANS Global Anhedonia score. Scores can range from 0-5, with higher scores indicating more severe anhedonia.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244741|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) Total Score|SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244742|NCT00547118|Primary|N-Back Neurocognitive Task: 2-back Condition|The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
1244831|NCT00546754|Primary|Change in Diastolic Blood Pressure From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mm Hg||Standard Deviation|Mean
1244743|NCT00547118|Primary|N-Back Neurocognitive Task: 1-back Condition|The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
1244744|NCT00547118|Primary|N-Back Neurocognitive Task: 0-back Condition|The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
1244745|NCT00547118|Primary|The Iowa Gambling Task (IGT)|The Iowa Gambling Task (IGT) is a computer-administered cognitive test that assesses risk preferences by simulating real-life decision making using uncertainty, rewards, and penalties. In the task, players are given four decks of cards and an endowment of fake money (e.g., $2000). Players are instructed to select cards one at a time and try to lose the least amount of money and win the most. The outcome measure was the number of rewarded minus punished card choices. Task has a maximum of 100 trials. The net score is the difference between the number of choices from advantageous decks verses disadvantageous decks. Higher scores are better and can range from -50 to +50.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
1244746|NCT00547118|Primary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
1244747|NCT00547118|Primary|Brief Psychiatric Rating Scale (BPRS) Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244748|NCT00547118|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|"The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
1244749|NCT00547105|Secondary|Progression-free Survival|"For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy."|up to 5 years||||months||Full Range|Median
1244750|NCT00547105|Secondary|Out-of-field Disease Progression|Number of Participants with Disease Progression Outside the Radiation treated field at 9 Months|9 months|The other three patients died or had not otherwise reached this window for evaluation.|||Participants|||Count of Participants
1244751|NCT00547105|Secondary|Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy|To evaluate the duration of erlotinib usage and time to initiation of third line systemic agent (chemotherapy or biologic agent)|3 years||||days||Full Range|Median
1244752|NCT00547105|Secondary|Overall Survival|evaluate overall survival after SBRT in combination with erlotinib|up to 5 years||||months||Full Range|Median
1244753|NCT00547105|Secondary|Number of Participants Without Serious Adverse Events Related to Radiation|Common Terminology Criteria for Adverse Events v4.03 (CTCAE) is used as the standard classification and severity grading scale for adverse events|3 years||||Participants|||Count of Participants
1244754|NCT00547105|Secondary|In-field Local Control|In-field local control is defined as number of treated lesions that did not grow in size or increase in metabolic activity.|9 months|21 out of 24 patients were evaluable with baseline and minimum 3-month follow-up CT based imaging. The other three patients died or had not otherwise reached this window for evaluation.|||lesions treated with SBRT|lesions treated with SBRT||Count of Units
1245024|NCT00545779|Secondary|Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B||Baseline to Month 6|Analysis was not performed because the data were difficult or impossible to derive from the database.||||||
1244755|NCT00547105|Primary|6 Month Progression-Free Survival|"For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy."|6 months|Twenty-four patients with stage IV Non-small-Cell Lung Caner with six or fewer sites of disease after progressing through first-line or subsequent systemic therapy were enrolled on the study.|||percentage of participants|||Number
1244756|NCT00546910|Primary|Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||Q-scores||Standard Deviation|Mean
1244757|NCT00546910|Primary|Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||Q-scores||Standard Deviation|Mean
1244758|NCT00546910|Primary|Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||Q-scores||Standard Deviation|Mean
1244759|NCT00546910|Secondary|Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8|Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3).|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
1244760|NCT00546910|Secondary|Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8|CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
1244761|NCT00546910|Secondary|Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
1244762|NCT00546910|Primary|Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8|Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks (W8)|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||Q-scores||Standard Deviation|Mean
1244763|NCT00546897|Secondary|Plasma Proteins Via Proteomics|Proteomic analysis will be performed within the Siteman Cancer Center proteomics core on pre- and post-treatment plasma samples. This pilot proteomic study will identify candidate proteins of interest with altered expression after treatment with lenalidomide. This approach will provide an unbiased method to assess global changes in serum proteins following lenalidomide therapy.|Pre and post treatment|This outcome was not analyzed for either Cohort due to sample collection.||||||
1245025|NCT00545779|Secondary|Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B||Visit 0 (<= Day -30)|The ITT population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
1244764|NCT00546897|Secondary|Gene Expression Profiles of Bone Marrow and Peripheral Blood|RNA will be made from total bone marrow cells for labeling and evaluations by RNA profiling. Cellular RNA and corresponding biotinylated cRNA targets will be prepared and hybridized with Affymetrix GeneChip® microarrays within the Multiplexed Gene Analysis SCC Core (Dr. Mark Watson, Director). Microarray data (and eventually corresponding gene sequence data) will be integrated an analyzed with state-of-the-art software packages. The pre- and post-treatment RNA profiling studies will be used as a discovery tool. Patterns of gene expression before and after lenalidomide therapy will be compared within each patient’s sample to identify genes with altered expression after lenalidomide therapy. In addition, supervised algorithms will be sued to identify genes that can potentially predict clinical outcome and response to lenalidomide therapy.|Pre and post treatment|This outcome measure was not analyzed for either Cohort due to sample collection.||||||
1244765|NCT00546897|Secondary|Changes in NK Cell Number and Function|Peripheral blood mononuclear cells (PBMC) will be viably cryopreserved from patients at baseline (pre-therapy, newly diagnosed AML), during lenalidomide therapy, and posttherapy. Following sample collection, PBMC will be thawed, and flow cytometry will be performed to assess NK cell number (CD56+CD3-), subsets, and phenotype utilizing the Siteman Cancer Center Flow Cytometry / Cell Sorting Core. In addition, NK cell function will be assessed in flow based killing assays using PBMC (containing NK cells) as effectors and NK sensitive cell lines (K562) and/or autologous leukemic blasts as target cells. Thus, analyzing these parameters in patients before, during, and after therapy will provide a comprehensive evaluation of the ability of lenalidomide to modulate NK cells in patients in vivo.|Baseline, during therapy, and posttherapy|This outcome was not analyzed for either Cohort due to number of samples collected.||||||
1244766|NCT00546897|Secondary|Duration of CR for Complete Responders|Duration of remission: Defined as the interval from the date complete remission is documented to the date of recurrence|2 years|Participants in Cohort 1 were not analyzed for duration of remission because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.|||months||Full Range|Median
1244767|NCT00546897|Secondary|Relapse Free Survival (RFS) for Complete Responders|This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|2 years|Participants in Cohort 1 were not analyzed for relapse free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.|||months||95% Confidence Interval|Median
1244768|NCT00546897|Secondary|Progression-free Survival|Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment. It is the percentage of individuals in the group whose disease is likely to remain stable (and not show signs of progression) after a specified duration of time. Progression-free survival rates are an indication of how effective a particular treatment is.|2 years|Participants in Cohort 1 were not analyzed for progression-free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.|||months||95% Confidence Interval|Median
1244769|NCT00546897|Secondary|Event Free Survival (EFS)|Event free survival: Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.|2 years|Event free survival was not analyzed. Progression free survival was analyzed instead.||||||
1244770|NCT00546897|Secondary|Overall Survival (OS)|Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.|2 years|Participants in Cohort 1 were not analyzed for overall survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.|||months||95% Confidence Interval|Median
1244771|NCT00546897|Secondary|Partial Remission Rate (PR)|Partial remission (PR): Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
1244772|NCT00546897|Secondary|CR With Complete Blood Counts (CRi) Rate|CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
1244773|NCT00546897|Secondary|Cytogenetics CR Rate (CRc)|Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
1244774|NCT00546897|Secondary|Morphologic Complete Remission Rate (CRm)|CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
1244776|NCT00546897|Secondary|Response Rate (RR)|"RR = as patients obtaining any response (CRm + CRc +CRi + PR).~CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRc = Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Partial remission (PR): Requires"|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
1244777|NCT00546897|Secondary|Safety and Tolerability (Removal From Study Due to Adverse Events)|Toxicity will be scored using CTCAE Version 3.0 for toxicity and adverse event reporting|4 weeks after last dose of study drug [median duration of therapy was 65 days (range, 3-413 days)]||||participants|||Number
1244778|NCT00546897|Primary|Complete Remission Rate (CRm + CRi + CRc)|"CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells)."|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
1244779|NCT00546884|Primary|Completion of Advance Directive|Completing an advance directive for the individuals health care when they are not able to direct it themselves|21 months||||Participants|||Count of Participants
1244780|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Percentage of infusions|Infusions||Number
1244781|NCT00546871|Primary|Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)|||Percentage of Infusions|Infusions|95% Confidence Interval|Number
1244782|NCT00546871|Primary|Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)|||Percentage of Infusions|Infusions|95% Confidence Interval|Number
1244783|NCT00546871|Primary|Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|Full safety data set (all participants who received any study drug)|||Percentage of Infusions|Infusions|95% Confidence Interval|Number
1244784|NCT00546871|Primary|Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)|||Percentage of Participants|||Number
1244785|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Percentage of infusions|Infusions||Number
1244786|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Percentage of infusions|Infusions||Number
1244787|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Percentage of infusions|Infusions||Number
1244788|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AE Related to the Study Drug||Throughout the study period (1 year and 9 months)|All participants who received any study drug|||Percentage of infusions|Infusions||Number
1244832|NCT00546754|Secondary|Change in Uric Acid From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||umol/L||Standard Deviation|Mean
1244789|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts|||AEs per infusion|||Number
1244790|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts|||Adverse events|||Number
1244791|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts|||AEs per infusion|||Number
1244792|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts|||Adverse events|||Number
1244793|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|All study participants who received any study drug during each of the study parts|||AEs per infusion|||Number
1244794|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|All study participants who received any study drug during each of the study parts|||Adverse events|||Number
1244795|NCT00546871|Primary|Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped.|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)|||Percentage of Participants|||Number
1244796|NCT00546871|Secondary|Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs|Proportion of Participants Reporting 1 or More Moderate or Severe AEs That Begin During Infusion or Within 72 Hours of Completion of an Infusion.|During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Proportion of participants|||Number
1244797|NCT00546871|Secondary|Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L)|"Frequency of Dose Adjustments Based on IgG Trough Levels <4.5 g/L IgG, if Any, for Each Study Part.~Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set."|Throughout the study period (1 year and 9 months)|All participants who received any study drug|||ratio|||Number
1244798|NCT00546871|Secondary|AEs Deemed/Judged to be Related by the Investigator|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug that occur at any time during the study divided by the total number of infusions.|Throughout the study period (1 year and 9 months)|All participants who received any study drug|||AEs per infusion|Infusions||Number
1244799|NCT00546871|Secondary|Rate of Temporally Associated AEs Per Infusion|Rate of AEs per infusion defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion (“temporally associated”) divided by the total number of infusions.|During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||AEs per infusion|Infusions||Number
1244800|NCT00546871|Secondary|Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS)|Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with an allowance for overdispersion by the deviance method.|Throughout the study, 1 year and 9 months|Full Safety Data Set (All study participants who received any infusions)|||Estimated infections/year|||Number
1244801|NCT00546871|Secondary|Annual Infection Rates During Treatment|Annual rate of all infections calculated using a Poisson model to account for different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with allowance for overdispersion by deviance method. Point estimates and likelihood-ratio based 95% confidence intervals were provided. Infections as included in analysis comprised all reported AEs that were coded to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations, described as an infection by investigator, or for which anti-infective medication was prescribed.|Throughout the study, 1 year and 9 months|Full safety data set (all participants who received any study drug)|||Estimated infections per year||95% Confidence Interval|Mean
1245572|NCT00541658|Secondary|Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population||Week 26|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244802|NCT00546871|Secondary|Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level|Antibody Titers That Were Below or Above the Protective Titer Level of >1:8 for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. Participants had multiple anti-measles antibody titers measured during the study.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All study participants|||Antibody titers|Antibody titers||Number
1244803|NCT00546871|Secondary|Trough Levels of Antibody to Tetanus In All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results|||IU/mL||95% Confidence Interval|Median
1244804|NCT00546871|Primary|Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|Full safety data set (all participants who received any study drug)|||Percentage of Participants|||Number
1244805|NCT00546871|Secondary|Trough Levels of Antibody to Hepatitis B in All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results|||mIU/mL||95% Confidence Interval|Median
1244806|NCT00546871|Secondary|Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results|||µg/mL||95% Confidence Interval|Median
1244807|NCT00546871|Secondary|Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older|"Part 1: IgG trough levels measured at each IV infusion day (every 3rd or 4th week depending on schedule/frequency of participants for a total of 12 weeks)~Part 2: IgG trough levels measured at weeks 1, 5 and 9 (of a total of 12 weeks)~Part 3a: IgG trough levels measured at weeks 1 and 5 (of a total of 6 weeks)~Part 3b: IgG trough levels measured at weeks 1, 5, 9 and 12 (of a total of 12 weeks)"|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation|Full safety data set (all participants who received any study drug), 12 Years and Older|||g/L||95% Confidence Interval|Median
1244808|NCT00546871|Secondary|Study Part 3B: Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||mL/kg/day||95% Confidence Interval|Median
1244809|NCT00546871|Secondary|Study Part 3B: Area Under the Curve (AUC)|The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Study Parts 1, 2 and 3b, AUC(0-τ) was standardized for the infusion intervals (3 or 4 weeks vs. 1 week).|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g*days/L||95% Confidence Interval|Median
1244810|NCT00546871|Secondary|Study Part 3B: Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g/L||95% Confidence Interval|Median
1244811|NCT00546871|Secondary|Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max)|Time to reach C-max|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||days||95% Confidence Interval|Median
1244812|NCT00546871|Secondary|Study Part 3B: Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g/L||95% Confidence Interval|Median
1244813|NCT00546871|Secondary|Study Part 2 (SC): Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||mL/kg/day||95% Confidence Interval|Median
1244814|NCT00546871|Secondary|Study Part 2 (SC): Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g/L||95% Confidence Interval|Median
1244815|NCT00546871|Secondary|Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max)|Time to reach C-max|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||days||95% Confidence Interval|Median
1244817|NCT00546871|Secondary|Study Part 1 (IV): Terminal Half-life|Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50%during the terminal phase.|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"|||days||95% Confidence Interval|Median
1244818|NCT00546871|Secondary|Study Part 1 (IV): Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"|||mL/kg/day||95% Confidence Interval|Median
1244819|NCT00546871|Secondary|Study Part 1 (IV): Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"|||g/L||95% Confidence Interval|Median
1244820|NCT00546871|Secondary|Study Part 1 (IV): Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"|||g/L||95% Confidence Interval|Median
1244821|NCT00546871|Primary|Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years.|"Administration of IGIV, 10%:~Part 1 = IV administration (IV)~Parts 2, 3a, 3b = SC administration (SC)"|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation|Full safety data set (all participants, aged 2 to <12 years who received any study drug)|||g/L||95% Confidence Interval|Median
1244822|NCT00546871|Primary|Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage|Expressed as (AUC_SC/AUC_IV) * 100|Week 12 (IV) and week 32 or 33 (SC)|Participants, ≥12 years, with PK data in terms of AUC[0-τ]/week following IV administration and SC administration of IGIV, 10% at an adjusted/individually adapted dose in Study Part 3b|||percent||90% Confidence Interval|Number
1244823|NCT00546819|Secondary|Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.|The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.|42 days postvaccination|Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.|||Ratio||95% Confidence Interval|Mean
1244824|NCT00546819|Secondary|Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination|The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).|42 days postvaccination|Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.|||gpELISA units/mL||95% Confidence Interval|Mean
1244825|NCT00546819|Primary|Number of Participants With Serious Adverse Events (SAE)|"A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|Up to 182 days postvaccination|"All participants who were vaccinated and had any safety~follow-up were included in the safety analysis."|||Participants|||Number
1244826|NCT00546754|Secondary|Change in Gamma-Glutamyl Transpeptidase (Gamma–GT) From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 254 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||IU/L||Standard Deviation|Mean
1244827|NCT00546754|Secondary|Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 300 and 273 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||IU/L||Standard Deviation|Mean
1244828|NCT00546754|Secondary|Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 255 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||umol/L||Standard Deviation|Mean
1244829|NCT00546754|Secondary|Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 304 and 272 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mg/L||Standard Deviation|Mean
1244830|NCT00546754|Secondary|Change in Uric Acid From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 286 and 253 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||umol/L||Standard Deviation|Mean
1244834|NCT00546754|Secondary|Number of Patients Achieving Target Blood Pressure at Week 12|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 12|12 Weeks|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 372 and 332 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||Patients|||Number
1244835|NCT00546754|Primary|Change in Systolic Blood Pressure From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mm Hg||Standard Deviation|Mean
1244836|NCT00546754|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 6|Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 393 and 345 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||Patients|||Number
1244837|NCT00546754|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mm Hg||Standard Deviation|Mean
1244838|NCT00546754|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mm Hg||Standard Deviation|Mean
1244839|NCT00546728|Primary|Change in Reactive Hyperemic Index Over the 3-month Treatment Period|Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.|Change from baseline to 3 months|All completers were included in the analysis|||ratio||Standard Deviation|Mean
1244840|NCT00546715|Secondary|Change From Baseline in Blood Pressure to Day 7 or Discharge|Changes in blood pressure from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement.|Baseline (Day 1), Day 7 or Discharge||||mmHg||Standard Deviation|Mean
1244841|NCT00546715|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters (PR, QRS, QT, and QTc Intervals) to Day 7 or Discharge|The ECG was recorded after the participant was in a supine position for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. QTc was defined as corrected QT interval at a heart rate of 60 bpm. QTc was estimated using Bazett’s formula and Fredericia’s formula.|Baseline (Day 1), Day 7 or Discharge|The analysis was performed in the safety population.|||msec||Standard Deviation|Mean
1244842|NCT00546715|Secondary|Change From Baseline in Heart Rate to Day 7 or Discharge|Changes in heart rate from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The normal heart rate lies between 60-90 beats per minute (bpm), below 60 bpm and above 90 bpm were considered as bradycardia and tachycardia, respectively.|Baseline (Day 1), Day 7 or Discharge|The analysis was performed in the safety population.|||bpm||Standard Deviation|Mean
1244843|NCT00546715|Secondary|Time to Reach Maximum Decline in Plasma Hepatitis C Virus RNA Levels From Baseline|Participants were assessed for time to reach maximum decrease in log10 hepatitis C virus RNA level. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.|Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1|The analysis was performed in the PD population defined as participants who received at least one dose of study medication with available valid data.|||hours||Standard Deviation|Mean
1244844|NCT00546715|Secondary|Decline From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Positive value indicated reduction from baseline in HCV RNA while negative value indicated an increase from baseline in HCV RNA. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.|Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1|The analysis was performed in the pharmacodynamic (PD) population defined as participants who received at least one dose of study medication with available valid data.|||log IU/mL||Standard Deviation|Mean
1244845|NCT00546715|Secondary|Apparent Total Body Clearance (CLT/F)|Apparent total body clearance (CLT/F) was calculated as Dose/AUC(INF), where CLT was the clearance of the drug and F was the absolute oral bioavailability. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1244846|NCT00546715|Secondary|Plasma Half-life (T-half)|Plasma half-life was defined as the time required for one half of the total amount of administered drug eliminated from the body. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.|||hours||Standard Deviation|Mean
1244847|NCT00546715|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax was defined as the time required to reach maximum observed plasma concentration. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.|||hours||Full Range|Median
1244848|NCT00546715|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. It was calculated as the sum of linear trapezoids using non-compartmental analysis. Area under the plasma concentration-time curve from time zero extrapolated to infinite time was estimated as sum of AUC(0-T) and the extrapolated area, computed by the quotient of the last observable concentration and λ, where λ was the slopes of the terminal phases of the plasma concentration-time profiles. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1244849|NCT00546715|Secondary|Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C-12) and 24 Hours (C-24)|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. C-12 and C-24 were defined as observed plasma concentration of daclatasvir at 12 hours and 24 hours, respectively. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the pharmacokinetic (PK) set population defined as all participants who received at least single dose of daclatasvir with available valid data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1244850|NCT00546715|Primary|Number of Participants With Marked Abnormalities in Laboratory Findings|Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*pre-treatment value, Leukocytes (low) as <0.9*lower limit of normal, Aspartate Aminotransferase (high) as >1.25*upper limit of normal, Creatinine (high) as >1.33*pre-treatment value, Bicarbonate (high) as >1.2*upper limit of normal, Total Protein (high) as >1.1*upper limit of normal, Creatinine Kinase (high) as >1.5*upper limit of normal, Blood in Urine (high) as ≥ 2*upper limit of normal. Participants were fasted for at least 10 hours prior to the collection of blood specimens for clinical laboratory tests.|Day 1 up to Day 7|The analysis was performed in the safety population.|||participants|||Number
1244851|NCT00546715|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements and Physical Examination Findings|Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the subject. Weight was measured at the discharge. The criteria for clinically significant change was as per the investigators discretion.|Day 1 up to Day 7 or Discharge|The analysis was performed in the safety population.|||participants|||Number
1244852|NCT00546715|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding) or disease which either occurs during study, whether or not related to the study drug. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 up to Day 7 for non-SAEs and Day 1 to 30 days after study discontinuation for SAEs|Analysis was performed in safety population defined as all participants who received any study drug treatment.|||participants|||Number
1244853|NCT00546637|Secondary|Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)|Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation)|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug.|||participants|||Number
1244854|NCT00546637|Secondary|Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)|Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug.|||participants|||Number
1244855|NCT00546637|Secondary|Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12|Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 12 (LOCF) were included in the analysis.|||ml/sec||Full Range|Median
1244856|NCT00546637|Secondary|Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12|Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.|Baseline, Week 4, 8 and 12|The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 4, Week 8 (LOCF), or Week 12 (LOCF) were included in the analysis.|||ml||Full Range|Median
1244857|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)|The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
1244858|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)|The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
1244859|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)|The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
1244860|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)|The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
1244861|NCT00546637|Secondary|Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12|HRQL domain and total raw score derived as sum of scores (6-point scale: 1 = not at all/none of the time; 6 = a very great deal/all of the time). Transformed score range 0 to 100 (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
1244862|NCT00546637|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12|OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
1244863|NCT00546637|Secondary|Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.|Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 12|FAS subjects with non-missing Baseline and Week 12 values (LOCF).|||participants|||Number
1244864|NCT00546637|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4|Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 4|FAS subjects with non-missing Baseline and Week 4 values.|||participants|||Number
1244865|NCT00546637|Secondary|Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12|"PPBC: self-administered, single-item, validated questionnaire. Rated on a 6–point scale: subject was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2."|Baseline, Week 12|FAS subjects with non-missing Baseline and Week 12 values (LOCF).|||participants|||Number
1244866|NCT00546637|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4|"PPBC: self-administered, single-item, validated questionnaire. Rated on a 6–point scale: subject was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2."|Baseline, Week 4|FAS subjects with non-missing Baseline and Week 4 values.|||participants|||Number
1244867|NCT00546637|Secondary|Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 12|FAS subjects with non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
1244868|NCT00546637|Secondary|Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 4|FAS subjects with non-missing change from Baseline to Week 4 were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
1244869|NCT00546637|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
1245026|NCT00545779|Secondary|Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B||Up to Month 6|The ITT population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
1244870|NCT00546637|Secondary|Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
1244871|NCT00546637|Secondary|Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
1244872|NCT00546637|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
1244873|NCT00546637|Secondary|Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12|The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline (LOCF) were included in the analysis.|||USS Sum rating per 24 hours||Standard Error|Least Squares Mean
1244874|NCT00546637|Secondary|Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
1244875|NCT00546637|Secondary|Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of episodes||Standard Error|Least Squares Mean
1244876|NCT00546637|Secondary|Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Severe micturition-related urgency episodes are defined as those with a USS rating ≥4 marked for the corresponding micturition in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
1244877|NCT00546637|Secondary|Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Severe micturition related urgency episodes were defined as those micturitions with USS rating >=4 marked for the corresponding micturition in the diary. USS: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of episodes||Full Range|Median
1244878|NCT00546637|Secondary|Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12|UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (UUI Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
1244879|NCT00546637|Secondary|Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4 and Week 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of episodes||Full Range|Median
1244880|NCT00546637|Secondary|Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal micturitions at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
1244881|NCT00546637|Secondary|Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of micturitions||Standard Error|Least Squares Mean
1244882|NCT00546637|Secondary|Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Micturitions at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
1244883|NCT00546637|Secondary|Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of micturitions||Standard Error|Least Squares Mean
1244884|NCT00546637|Secondary|Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|"Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of >= 3 marked for the corresponding micturition in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as:~100* (Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline"|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
1244885|NCT00546637|Secondary|Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 were included in the analysis.|||number of episodes||Standard Error|Least Squares Mean
1244886|NCT00546637|Primary|Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|The full analysis set (FAS) included all subjects who took at least one dose of assigned study drug and had at least one baseline or post-baseline efficacy assessment. Only FAS subjects with non-zero micturition-related urgency episodes at Baseline and non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.|||number of episodes||Standard Error|Least Squares Mean
1244887|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244888|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244921|NCT00546364|Secondary|Duration of Response|Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.|Baseline (date of randomization) to date CR or PR criteria first met|This study was terminated due to inadequate enrollment. Consequently, duration of response was not analyzed.||||||
1245573|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. LOCF at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244889|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244890|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244891|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Year 0). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244892|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244893|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244894|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244895|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244896|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0|Safety population is all participants who receive at least 1 dose of study vaccine. N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Vax 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1244897|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1244898|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.|||geometric mean titers||95% Confidence Interval|Geometric Mean
1244899|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)|Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype at both the postvaccination 1 and postvaccination 2 blood draws.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1244900|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.|1 month after Vax 1 / Year 0|Evaluable Immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1244901|NCT00546572|Primary|Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.|Baseline, 1 month after Vax 1 / Year 0|Evaluable Immunogenicity population. N=number of participants with a determinate antibody titer to the given serotype.|||observed percentage of participants||95% Confidence Interval|Number
1244902|NCT00546572|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0|Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate OPA antibody titer to the given serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1244903|NCT00546481|Secondary|Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24|Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|Up to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.|||Number of participants|||Number
1244904|NCT00546481|Secondary|Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24|Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|From Baseline (Day 1) to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.|||Beats per minute for heart rate||Standard Deviation|Mean
1244905|NCT00546481|Secondary|Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24|Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|From Baseline (Day 1) to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.|||millimeters of mercury||Standard Deviation|Mean
1244906|NCT00546481|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 49|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|||Number of participants|||Number
1244907|NCT00546481|Secondary|Number of Participants Who Received Red Blood Cells Transfusions up to Week 49|The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)|Up to Week 49|The Intent-to-Treat Population included all randomized participants.|||Number of participants|||Number
1244908|NCT00546481|Secondary|Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24|Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.|Up to Week 24|The Intent-to-Treat population included all randomized participants.|||Days||95% Confidence Interval|Median
1244909|NCT00546481|Secondary|Mean Change From Baseline in Hemoglobin Concentration at Week 24|Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value|From Baseline (Day 1) to Week 24|The Intent-to-Treat population included all randomized participants.|||Grams per deciliter (g/dL)||Standard Deviation|Mean
1244910|NCT00546481|Primary|Percentage of Participants Who Achieved Hemoglobin Response up to Week 24|Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented|Up to Week 24|The Intent-to-Treat population included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1244911|NCT00546429|Secondary|Merle d'Aubigne and Postel||4 weeks, 3, 6 and 12 months|||||||
1244912|NCT00546429|Secondary|SF-12||4 weeks, 3, 6 and 12 months|||||||
1244913|NCT00546429|Secondary|Six Item Screener and Ambulatory Status||4 weeks, 3, 6 and 12 months|||||||
1244914|NCT00546429|Secondary|Medical Imaging||4 weeks, 3, 6 and 12 months|||||||
1244915|NCT00546429|Secondary|Lower Extremity Measure (LEM)||4 weeks, 3, 6 and 12 months|||||||
1244916|NCT00546429|Primary|Success in Terms of the Merle D'Aubigne Score|Merle D'Aubigne measures pain, mobility and ability to walk using a 0 to 6 scoring scale, with 0 indicating worse outcomes and 6 indicating better outcomes.|4 weeks, 3, 6 and 12 months||||Units on a scale||Standard Deviation|Mean
1244917|NCT00546377|Primary|Maximum Tolerated Dose (MTD) of Mitoxantrone|The MTD is defined as the highest dose studied for which the incidence of DLT is less than 33%. In the phase I portion of the trial, cohorts of 3-6 pts will receive pentostatin, cyclophosphamide and rituximab along with one of three potential dose levels of mitoxantrone. The following dose escalation scheme will be followed: If none of the initial three pts in a cohort experience a dose-limiting toxicity (grade 4 infection, or grade ≥ 3 non-hematologic toxicity that persists for 7 days or more) then a new cohort of three pts will be treated at the next higher dose level. If one of the three pts in a cohort experiences DLT, then up to three additional pts will be treated at the same dose level. If two or more pts in a cohort experience DLT, then the maximum tolerated dose (MTD) will have been exceeded, and no further dose escalation will occur. The previous dose level will be considered as the MTD.|2 years||||mg/m2|||Number
1244918|NCT00546377|Primary|Overall Response|Complete response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment): it is recognized that some patients with lymphoid malignancies who achieve a CR may have mild persistent abnormalities on CT Scan. Such abnormalities if stable on subsequent scanning will not be viewed as persistent disease in patients who otherwise meet the criteria for CR. Response will be assessed on an ongoing basis, but at a minimum of prior to cycle four and following completion of all therapy. Patients who are removed from study early will have response status determined at time of removal from study. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.|3 years||||participants|||Number
1244919|NCT00546364|Secondary|Median Number of Treatment Cycles|The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.|Day 1 to end of Cycle 18, maximum (54 weeks)|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.|||Treatment cycles||Full Range|Median
1244920|NCT00546364|Primary|Percentage of Participants With Best Response to Treatment of Complete or Partial|The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.|Baseline to 6 weeks (end of Cycle 2)|All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.|||Percentage of patients|||Number
1245574|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population||Week 104|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1244922|NCT00546364|Secondary|Time to Progression|Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.|Baseline to date progressive disease reported|This study was terminated due to inadequate enrollment. Consequently, time to progression was not analyzed.||||||
1244923|NCT00546364|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Results|ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.|Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.|||Participants|||Number
1244924|NCT00546364|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade|CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.|Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.|||Participants|||Number
1244925|NCT00546364|Secondary|Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.|Baseline to end of Cycle 1 (21 days), continuously|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.|||Participants|||Number
1244926|NCT00546364|Secondary|Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort|The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.|Baseline to 6 weeks (end of Cycle 2)|All NTN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.|||Percentage of NTN Participants|||Number
1244927|NCT00546364|Secondary|Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial|The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).|Baseline to 6 weeks (end of Cycle 2)|All TN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.|||Percentage of TN Participants|||Number
1244928|NCT00546364|Primary|Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.|Baseline to 6 weeks (end of Cycle 2)|All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.|||Participants|||Number
1244929|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Last Visit.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.~Data was not available for 69 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244930|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Baseline.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Baseline|"Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.~Data was not available for 33 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244946|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity at Last Visit.|0 = no pain and 10 = most intense pain sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects of the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1245575|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. LOCF at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
1244931|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Physical Component Summary (PCS) at Last Visit.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.~Data was not available for 69 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244932|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Physical Component Summary (PCS) at Baseline.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Baseline|"Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.~Data was not available for 33 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244933|NCT00546351|Secondary|Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.|0 = no interference with activity and 10 = worst possible interference with activity.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244934|NCT00546351|Secondary|Average Pain Interference With Activity (11-point Likert Scale) at Baseline.|0 = no interference with activity and 10 = worst possible interference with activity.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244935|NCT00546351|Secondary|Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.|0 = no interference with sleep and 10 = worst possible interference with sleep.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244936|NCT00546351|Secondary|Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.|0 = no interference with sleep and 10 = worst possible interference with sleep.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244937|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity at Last Visit.|0 = not sensitive and 10 = most sensitive sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244938|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness at Final Visit.|0 = not itchy and 10 = most itchy sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244939|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain at Last Visit.|0 = no deep pain and 10 = most intense deep pain imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244940|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain at Last Visit.|0 = no surface pain and 10 = most intense surface pain imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244941|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness at Final Visit.|0 = not unpleasant and 10 = most unpleasant sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244942|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness at Last Visit.|0 = not dull and 10 = most dull sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244943|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold at Last Visit.|0 = not cold and 10 = the coldest sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244944|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat at Last Visit.|0 = not hot and 10 = the most hot sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244945|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness at Last Visit.|0 = not sharp and 10 = most sharp sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244994|NCT00546052|Other Pre-specified|Percent Change in Triglycerides Between Baseline and 52 Week Assessments|Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks – Triglycerides Baseline) / (Triglycerides Baseline)].|52 Weeks - Baseline|Per Protocol|||Percent Change||Standard Deviation|Median
1244947|NCT00546351|Secondary|Patient’s Global Impression of Change (PGIC) at Last Visit.|"The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).~Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse)."|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 551 are included in this analysis.~Data was not available for 70 subjects at the time of this measurement."|||percentage of participants|||Number
1244948|NCT00546351|Secondary|Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.|On VAS 0 mm = no pain and 100 mm = worst possible pain.|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 214 are included in this analysis.~Data was not available for 407 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244949|NCT00546351|Secondary|Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.|Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.|Baseline|"Of the 621 subjects in the Safety Set (SS), 213 are included in this analysis.~Data was not available for 408 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244950|NCT00546351|Secondary|Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.|On the Likert Scale, 0 = no pain and 10 = worst possible pain.|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244951|NCT00546351|Secondary|Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.|On the Likert Scale, 0 = no pain and 10 = worst possible pain.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."|||units on a scale||Standard Deviation|Mean
1244952|NCT00546351|Primary|Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).|"A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:~Is fatal~Is life-threatening~Results in persistent or significant disability/incapacity~Requires inpatient hospitalization~Prolongs existing inpatient hospitalization~Is a congenital anomaly/birth defect~Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above"|From entry Visit 1 through end of treatment (approximately 6.5 years)|This analysis includes all subjects (all 621) in the Safety Set (SS).|||participants|||Number
1244953|NCT00546351|Primary|Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|From entry Visit 1 through end of treatment (approximately 6.5 years)|This analysis includes all subjects (all 621) in the Safety Set (SS).|||participants|||Number
1244954|NCT00546273|Primary|Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression|haematological and biochemical laboratory tests|at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156|All the participants of the study were analyzed for this specific outcome measure.|||number of abnormalities|||Number
1244955|NCT00546273|Primary|Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events||during the whole study||2008-11-30|11/2008||||
1244956|NCT00546273|Secondary|Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested|Immunological assays are performed at all timepoints to determine vaccine immunogenicity|at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156||2008-11-30|11/2008||||
1244957|NCT00546273|Primary|VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point||at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56||2008-11-30|11/2008||||
1244958|NCT00546260|Secondary|Percentage ST-segment Resolution Prior to PCI|The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI.|Before primary PCI|Per protocol.|||Percentage of ST-segment Resolution||Inter-Quartile Range|Median
1244959|NCT00546260|Secondary|Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI|This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter.|Time for contrast to reach a standardized distal coronary landmark in the culprit vessel|Per protocol|||frames per minute||Inter-Quartile Range|Median
1244960|NCT00546260|Primary|Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days|"TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit.~TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10–15%.~GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention.~GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention.~Stroke:New focal neurologic deficit that does not resolve within 24 hours."|30 days|"All subjects receiving some component of study drug (the as-treated population)"|||Participants|||Number
1244961|NCT00546156|Secondary|Decrease in Interstitial Fluid Pressure.|To determine if bevacizumab monotherapy results in a decrease in interstitial fluid pressure|3 years|This represents the number of patients with paired IFP measurements from day 0 and day 14|||mm Hg||Inter-Quartile Range|Median
1244962|NCT00546156|Primary|Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.|Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery|3 Years|Participants who met all study eligibility criteria and signed informed consent.|||percentage of participants|||Number
1244963|NCT00546117|Secondary|Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire|Questions regarding reflux symptoms, created and evaluated by Nelson et al, Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey, Arch Pediatr Adolesc Med 2000;154;150-154. This study used the GER3-9P version for children aged 3-9 years. Results are reported as number reporting at least one specific symptom in the past week, maximum 7 symptoms.|2 months||||Participants|||Count of Participants
1244964|NCT00546117|Secondary|Number of Participants With Normal Type A Tympanometry|"Tympanometry of both ears, coded by Jerger classification (Type A, normal; type B, flat; Type C; negative pressure).~This is a standard test of middle ear status as performed by audiologists. Please refer to the reference for more information: Kileny & Zwolan, Diagnostic Audiology, chapter 133, Cummings Otolaryngology-Head and Neck Surgery, Elsevier/Saunders, 2015."|2 months||||Participants|||Count of Participants
1244965|NCT00546117|Secondary|Acoustic Reflectometry: Level of Risk as Defined by Manufacturer|Spectral gradient acoustic reflectometry is a noninvasive, non-audible acoustic wave used to help detect middle ear fluid. The manufacturer recommends interpretation of the angle result as: <49°, high risk of middle ear effusion (level 5); 49–59°, moderate-high risk (level 4); 60–69°, moderate risk (level 3); 70–95°, low-moderate risk (level 2) and >95°, low risk (level 1).|2 months||||level of risk||Full Range|Mean
1244966|NCT00546117|Primary|Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar||2 months||||participants|||Number
1244967|NCT00546117|Primary|Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear||2 months||||participants|||Number
1244968|NCT00546104|Secondary|To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption|Not assessed secondary to limited number of subjects.|not assessed|||||||
1244969|NCT00546104|Secondary|To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression.|Spearman's correlation between the change in SRC signature from baseline to 4 weeks and time to progression|Baseline Src measure to first progression|11 patients had both change in Src level and progression time intervals|||correlation coefficient|||Number
1244970|NCT00546104|Secondary|Correlate SRC Dysregulation Results With Response to Dasatinib Therapy|Since all patients progressed there is no comparison to between responders and non-responders.|16 weeks|20 patients with baseline and 4 week Src measures. 11 patients came off due to screen failure, toxicity or progression before 4 week biopsy.|||percentage change in p-SRC||95% Confidence Interval|Mean
1244971|NCT00546104|Secondary|Characterization and Comparison of SRC (A Protein Tyrosine Kinase)Dysregulation at Baseline (All Patients), After 4 Weeks of Dasatinib Treatment (All Patients), and at Progression (Only Patients Who Progress After Documented Response)|For the 20 patients with evaluable biopsies at baseline and week 4, the median relative change from baseline in tissue biomarker levels of phospho-Src (p-Src)|4 weeks|Twenty patients with evaluable biopsies at baseline and 4 week follow-up|||percentage of change in p-SRC||Inter-Quartile Range|Median
1244972|NCT00546104|Secondary|To Measure Response to Protocol Therapy Per RECIST Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as a reference the smallest sum longest diameter recorded since treatment started, or the appearance of one or more new lesions.~RECIST 1.0 Overall response:~Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD)~CR= CR+CR and No new lesions PR= CR+SD; PR+SD and no new lesions SD= SD+SD and no new lesions PD= PD+any new lesions"|16 weeks|Proportion with Best Response of Stable Disease|||percentage of participants|||Number
1244973|NCT00546104|Primary|Estimation of the Proportion of Progression-free Patients at 16 Wks.|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as appropriate.~Proportion progression-free at 16 weeks.From first day of study related treatment with Dasatinib until the date of first documented progression or date of death from any cause, whichever came first."|16 weeks|31 patients on this trial, 1 patient was found to have disease progression at 16-weeks, 16 patients had disease progression prior to 16 weeks, 8 patients were taken off-treatment due to toxicity, and 6 patients voluntarily withdrew from treatment. These latter two groups of patients were censored in the analysis of Progression Free Survival.|||percentage of participants||95% Confidence Interval|Number
1244974|NCT00546078|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 18||||Participants|||Count of Participants
1244975|NCT00546078|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 18||||Participants|||Count of Participants
1244976|NCT00546078|Secondary|Outcome of Any Reported Pregnancies|Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.|From Day 0 up to Month 18|Analysis was performed on those subjects reporting pregnancy during the study period.|||Participants|||Count of Participants
1244977|NCT00546078|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed."|Within 30 days of vaccination||||Participants|||Count of Participants
1244978|NCT00546078|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.~Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed."|Within 7 days of vaccination|Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.|||Participants|||Count of Participants
1244979|NCT00546078|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed."|Within 7 days after vaccination|Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.|||Participants|||Count of Participants
1244980|NCT00546078|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).~Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter."|Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1244981|NCT00546078|Secondary|Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples|"Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.~Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter."|Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.|||Participants|||Count of Participants
1244982|NCT00546078|Secondary|Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.~A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.|||Participants|||Count of Participants
1244983|NCT00546078|Secondary|Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.~An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.|||Participants|||Count of Participants
1244984|NCT00546078|Secondary|Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.~An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.|||Participants|||Count of Participants
1244985|NCT00546078|Secondary|Anti-HPV-31 and Anti-HPV-45 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|Day 7, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity|||titer||95% Confidence Interval|Geometric Mean
1244986|NCT00546078|Secondary|Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL||Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity.|||Participants|||Count of Participants
1244987|NCT00546078|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as GMTs calculated on all subjects.|At Month 7 and Month 18|Analysis was performed on the APT cohort for immunogenicity|||titer||95% Confidence Interval|Geometric Mean
1244988|NCT00546078|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values|Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity.|||Participants|||Count of Participants
1244989|NCT00546078|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|At Day 7 and at Month 1 (Day 30)|Analysis was performed on the ATP cohort for immunogenicity.|||titer||95% Confidence Interval|Geometric Mean
1244990|NCT00546078|Primary|Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values|Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Day 7 and Month 1 (Day 30)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.|||Participants|||Count of Participants
1244991|NCT00546052|Other Pre-specified|Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments|Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks – C Reactive Protein Baseline.|52 Weeks - Baseline|Per Protocol|||mg/L||Standard Deviation|Mean
1244992|NCT00546052|Other Pre-specified|Absolute Change in Uric Acid Between Baseline and 52 Week Assessments|Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks – Uric Acid Baseline.|52 Weeks - Baseline|Per Protocol|||mmol/L||Standard Deviation|Mean
1244993|NCT00546052|Other Pre-specified|Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments|Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks – Total Cholesterol Baseline) / (Total Cholesterol Baseline)].|52 Weeks - Baseline|Per Protocol|||Percent Change||Standard Deviation|Mean
1244996|NCT00546052|Other Pre-specified|Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments|Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks – LDL-C Baseline) / (LDL-C Baseline)].|52 Weeks - Baseline|Per Protocol|||Percent Change||Standard Deviation|Mean
1244997|NCT00546052|Other Pre-specified|Change in Body Mass Index Between Baseline and 52 Week Assessments|Absolute change in Body Mass Index Baseline and 52 week assessments|52 Weeks - Baseline|Per Protocol|||Kg/m2||Standard Deviation|Mean
1244998|NCT00546052|Other Pre-specified|Change in Waist Circumference Between Baseline and 52 Week Assessments|Absolute change in Waist Circumference between baseline and 52 week assessments|52 Weeks - Baseline|Per Protocol|||cm||Standard Deviation|Mean
1244999|NCT00546052|Secondary|Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments|Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol|||mm Hg||Standard Deviation|Mean
1245000|NCT00546052|Secondary|Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments|Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol|||mm Hg||Standard Deviation|Mean
1245001|NCT00546052|Secondary|Target Blood Pressure|Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks|52 Weeks|ITT and Per Protocol|||Participants|||Number
1245002|NCT00546052|Primary|Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments|Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol|||mmol/L||Standard Deviation|Mean
1245003|NCT00546052|Primary|Change in Hemoglobin A1c Between 52 Weeks and Baseline|Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.|52 Weeks - Baseline|Per Protocol|||Percent||Standard Deviation|Median
1245004|NCT00546000|Secondary|Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity|The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.|Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29||||participants|||Number
1245005|NCT00546000|Primary|Post Treatment Serum Cortisol Values Will be Compared.|The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.|Up to 29 days of treatment||||participants|||Number
1245006|NCT00545974|Primary|Clinical Global Impression of Change (CGIC)|The scale is rated on a 7-point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The clinician compares the participant's current condition to the condition at admission to the project.|26 Weeks||||units on a scale||95% Confidence Interval|Mean
1245007|NCT00545974|Secondary|CDR-FTD, MMSE, FAQ, TFLS, EXIT25, UCSF FTD-Neuropsychological Test Battery: CVLT, Verbal Fluency, Modified BNT, Backward Digit Span, Digit Symbol Test, Modified Trails B, Modified Unified Parkinson's Disease Rating Scale, Antipsychotic Therapy||26 Weeks|||||||
1245008|NCT00545974|Primary|Change in Neuropsychiatric Inventory (NPI)|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions indicate that the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Mean
1245009|NCT00545948|Secondary|Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms|Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity. There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.|2 years|There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.||||||
1245010|NCT00545948|Secondary|Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer|Do to space limitations, see the Detailed Description in the study protocol for the wording of the questions used in the Patient Expectations Questionnaire.|Baseline|Twenty-six questionnaires were returned. There was insufficient numbers to provide for substantive analysis.||||||
1245011|NCT00545948|Secondary|2-Year Overall Survival in Patients Treated for NSCLC|Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive|2 years|Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.|||percentage of treated patients||95% Confidence Interval|Number
1245039|NCT00545740|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT scans|||Number
1245012|NCT00545948|Secondary|Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy|The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies.|4 years||||Percentage of participants|||Number
1245013|NCT00545948|Primary|2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC|Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive.|2 years|Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.|||percentage of treated patients||95% Confidence Interval|Number
1245014|NCT00545844|Other Pre-specified|Patient Global Allergic Rhinitis Symptoms Assessment|At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.|||Participants|||Number
1245015|NCT00545844|Other Pre-specified|Physician Global Satisfaction|At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient’s asthma controller medication.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.|||Participants|||Number
1245016|NCT00545844|Other Pre-specified|Patient Global Satisfaction|At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.|||Participants|||Number
1245017|NCT00545844|Secondary|Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)|The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale.|8 weeks (from Week 0 to Week 8)|There were 313 patients who qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit; of these, 300 patients completed the ACQ at week 8.|||Units on a Scale||Standard Deviation|Mean
1245018|NCT00545844|Secondary|The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score|Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score – Week 0 score|8 weeks (from Week 0 to Week 8)|Based on ITT population; there were 286 patients with available data regarding the mean change in MiniRQLQ at week 8.|||Units on a Scale||Standard Deviation|Mean
1245019|NCT00545844|Primary|Asthma Control|Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered “yes” to at least 2 of the 8 asthma control parameters.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.|||Participants|||Number
1245020|NCT00545792|Secondary|Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy|Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.|1-year|20 patients received and completed treatment.|||participants|||Number
1245021|NCT00545792|Primary|Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy|Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.|1-year|20 patients received and completed treatment.|||Events|||Number
1245022|NCT00545779|Secondary|Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B|The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1–6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11–16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0–100-point scale, in which higher scores indicate greater satisfaction.|Baseline, Month 6|The ITT population included all participants who received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
1245023|NCT00545779|Secondary|Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B||Month 6|Analysis was not performed because the data were difficult or impossible to derive from the database.||||||
1245027|NCT00545779|Secondary|Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B|"Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:~I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule~More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication~Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication"|Month 6|The ITT population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
1245028|NCT00545779|Secondary|Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ||Visit 0 (<= Day -30)|The ITT population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
1245029|NCT00545779|Primary|Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group|Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.|Month 6|The intent-to treat (ITT) population included all participants who received at least one dose of study medication. Number of participant analyzed are with or without previous history of Fr.|||percentage of participants|||Number
1245030|NCT00545779|Primary|Percentage of Participants Who Reported Preference for Monthly Ibandronate|Percentage of participants who reported preference for monthly ibandronate were reported.|Visit 0 (<= Day -30)|All enrolled participants who completed the part A of the study.|||percentage of participants|||Number
1245031|NCT00545779|Primary|Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer ‘Yes’ to Any of the Questions in the Candidate Identification Questionnaire (CIQ)|"The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option.~In the CIQ participants were asked to answer either ‘yes’ or ‘no’ to the following 3 questions:~I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.~More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.~Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication."|Visit 0 (less than or equal to [<=] Day -30)|All enrolled participants who completed the part A of the study.|||percentage of participants|||Number
1245032|NCT00545766|Secondary|Time to PSA Progression and Overall Survival Will be Summarized Via Kaplan-Meier-type Plots, and by Medians With Corresponding 95% Confidence Interval (CI).||18 months|||||||
1245033|NCT00545766|Primary|Protein-specific Antigen (PSA) Response Rate|Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.|18 months||||percentage of patients||95% Confidence Interval|Number
1245034|NCT00545753|Secondary|Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.|To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|558 subjects were randomized to treatment and 540 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. At Day 7 if subject presented with live lice they were provided a second treatment to be used within 24 hours. Thus subjects used 1 or 2 treatments.|||Incidents|||Number
1245035|NCT00545753|Primary|Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice|The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).|Assessment were made 14 days following the final product treatment|Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.|||participants|||Number
1245036|NCT00545740|Secondary|Percent of Subjects Requiring Surgery for Diverticulitis||Up to 104 weeks|Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product.|||percentage of subjects|||Number
1245037|NCT00545740|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT scans|||Number
1245038|NCT00545740|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT scans|||Number
1245201|NCT00544882|Secondary|Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods|The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat|||percentage of participants|||Number
1245040|NCT00545740|Primary|Percent of Subjects Without Recurrence of Diverticulitis|Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.|Up to 104 weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.|||percentage of subjects|||Number
1245041|NCT00545740|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT scans|||Number
1245042|NCT00545740|Secondary|Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis|CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.|Up to 104 weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.|||percentage of subjects|||Number
1245043|NCT00545688|Secondary|Progression Free and Disease Free Survival|DFS was defined as the time from the first date of no disease (date of surgery) to the first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. PFS was defined as the time from the date of randomization to the first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. DFS and PFS were determined using Kaplan-Meier estimates.|Randomization up to a maximum of 329 weeks|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants||80% Confidence Interval|Median
1245044|NCT00545688|Secondary|Percentage of Participants Who Were Progression Free and Disease Free|Disease-free survival (DFS) was defined as the time from first date of no disease to first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from the study without documented progression and for whom evaluations were made, were censored at date of last assessment when participant was known to be disease-free. Progression-free survival (PFS) was defined as time from date of randomization to first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from study without documented progression and for whom evaluations were made, were censored at date of last assessment when the participant was known to be free from progressive disease. Participants without post baseline assessments but known to be alive were censored at the time of randomization.|Randomization up to a maximum of 329 weeks|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants|||Number
1245045|NCT00545688|Secondary|Percentage of Participants Achieving Breast Conserving Surgery For Whom Mastectomy Was Planned|Breast Conserving Surgery (BCS) was defined as quadrantectomy, lumpectomy, no surgery, sentinel node biopsy, axillary surgical resection or other method of avoiding mastectomy.|Surgery (Within 2 weeks after Cycle 4) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1245046|NCT00545688|Secondary|Percentage of Participants With Progressive Disease During Neo-Adjuvant Treatment Period|Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: PD: if lesion is at least a 20 % increased from measurements at baseline. Percentage of participants along with 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method were reported. Missing investigator assessments were considered as no progressive disease.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
1245047|NCT00545688|Secondary|Time to Clinical Response During Neo-Adjuvant Treatment Period|Time to clinical response was defined as the time from the date of first dose received to the date of assessment of clinical response. Time to Clinical response was determined by Kaplan-Meier estimates. Tumor assessments were made based on the RECIST criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||months||80% Confidence Interval|Median
1245054|NCT00545688|Primary|Percentage of Participants Achieving pCR by Lymph Node Status|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants|||Number
1245576|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population||Week 52|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1245048|NCT00545688|Secondary|Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Primary breast tumor clinical response is based on primary breast tumor assessment. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome and n = number participants analyzed in the specified category.|||percentage of participants||95% Confidence Interval|Number
1245049|NCT00545688|Secondary|Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by X-Ray/Mammography|Clinical response was determined based on tumor measurements by sponsor in combination with tumor response assessment by investigator. Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome and n = number participants analyzed in the specified category.|||percentage of participants||95% Confidence Interval|Number
1245050|NCT00545688|Secondary|Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During the Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
1245051|NCT00545688|Secondary|Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
1245052|NCT00545688|Secondary|Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During Neo-Adjuvant Period by X-Ray/Mammography|Tumor assessments were made based on the RECIST criteria - version 1.0 The overall response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
1245053|NCT00545688|Primary|Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS)|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants|||Number
1245055|NCT00545688|Primary|Percentage of Participants Achieving pCR by Hormone Receptor Status|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization. n = number of participants included in the specified hormone receptor status.|||percentage of participants||95% Confidence Interval|Number
1245056|NCT00545688|Primary|Percentage of Participants Achieving pCR by Breast Cancer Type|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization. Number (n) equal (=) number of participants included in the specified type of breast cancer.|||percentage of participants||95% Confidence Interval|Number
1245057|NCT00545688|Secondary|Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography|Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is greater than (>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.|Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
1245058|NCT00545688|Primary|Percentage of Participants Achieving Pathological Complete Response (pCR)|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
1245059|NCT00545662|Primary|Functional and Cognitive Outcome|The primary outcome of this study was analyzed using a global statistic of the Network Core Battery. There were 9 scales: California Verbal Learning Test II (CVLT-II); Controlled Oral Word Association Test (COWAT); Digit Span (DS); Glasgow Outcome Scale Extended (GOSE); Processing Speed Index (PSI); Stroop Test 1 and 2 (ST1&2); and Trail Making Test part A and B (TMT parts A and B). Each scale was assigned cut-off for good outcome: GOSE>7, CVLT>36, PSI>85, TMT part A <42, TMT part B<138.1, DS>7.15, ST1<60.29, ST2<151.47, COWAT>32.5. Logistic regression was used to estimate the global OR.|90 days|The analysis included both the patients with complete outcome data and those with at least one measure. Patients who died were also included in the analysis.|||percentage of participants|||Number
1245060|NCT00545623|Primary|Changes in GI Symptom Per Intervention Session|We used the GI symptom subscale of the Revised HIV Sign and Symptom Checklist (SSC-HIV) to measure the intensity (0-10) of the six targeted GI symptoms: diarrhea, loose stools, gas/bloating, abdominal pain, nausea and vomiting, with 0 indicating no symptom and 10 indicating most sever symptom. Rating changes per intervention session were estimated using a mixed effects regression model controlling for baseline ratings. Data of loose stools are presented here.|8 weeks|An intent-to-treat approach was used for analysis. That is all patients who had at least one data points were included in the analysis.|||units on a scale||Standard Error|Mean
1245061|NCT00545584|Secondary|Fasting Plasma Glucose (FPG) Measurement|Generally FPG values of ~5.0–7.2 mmol/L would be considered goal (American Diabetes Association).|Baseline and Week 24|FAS population. Furthermore, only 350, 252, and 350 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Baseline; and 303, 224, and 310 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Week 24.|||mmol/L glucose||Standard Deviation|Mean
1245062|NCT00545584|Primary|Hemoglobin A1c Measurement|Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.|Baseline and Week 24|The Full Analysis Set (FAS) population included all selected patients with at least one measured HbA1c value after Visit 2 and having received at least one dose of sitagliptin. In the Standard of Care group, only 360 subjects had HbA1c Baseline evaluations.|||percent HbA1c||Standard Deviation|Mean
1245063|NCT00545571|Secondary|Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP|The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported.|From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52|ITT Population.|||percentage of participants|||Number
1245064|NCT00545571|Secondary|Mean Dose of Mircera/CERA During the DTP and LTSP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and LTSP and expressed in mcg.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|Safety Population; only those participants (n = number) who provided evaluable data were included in the analysis.|||mcg||Standard Deviation|Mean
1245065|NCT00545571|Secondary|Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The mean number of months required for dose adjustment for any reason was calculated and averaged among all participants during the DTP and LTSP.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|Safety Population: All participants who received at least one dose of trial medication and at least one safety follow-up assessment, whether prematurely withdrawn or not; only those participants (n = number) who provided evaluable data were included in the analysis.|||months||Standard Deviation|Mean
1245066|NCT00545571|Secondary|Mean Excursions Above or Below Target Range for Hb During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Deviation from the country-specific target range was calculated as [Hb value minus country-specific upper bound] for deviations above the target range and [Hb value minus country-specific lower bound] for deviations below the target range. Deviations were averaged among all Hb values from all participants and expressed in g/dL, reported separately as mean deviation above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and mean deviation below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.|||g/dL||Standard Deviation|Mean
1245067|NCT00545571|Secondary|Mean Time Spent Above or Below the Target Range for Hb During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent outside the country-specific target range was defined as time from each off-target Hb to time of next on-target Hb, as collected during the LTSP. Time spent outside the target range was averaged among all participants and expressed in days, reported separately as time spent above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and time spent below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP or at the last DTP visit were included in the analysis.|||days||Standard Deviation|Mean
1245068|NCT00545571|Secondary|Percentage of Hb Values Above or Below the Target Range During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of all Hb values outside of the country-specific target range was determined and reported separately as Hb values above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and Hb values below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.|||percentage of Hb values|||Number
1245069|NCT00545571|Secondary|Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1245070|NCT00545571|Secondary|Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only participants who entered the LTSP were included in the analysis.|||days||Standard Deviation|Mean
1245071|NCT00545571|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|ITT Population.|||g/dL||Standard Deviation|Mean
1245083|NCT00545532|Secondary|Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children|Reported here are oseltamivir data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||hour|||Number
1245317|NCT00543569|Secondary|Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12|Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245072|NCT00545571|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|Per Protocol (PP) Population: All participants from the Intent-to-Treat (ITT) Population who fulfill select criteria per study protocol.|||percentage of participants||95% Confidence Interval|Number
1245073|NCT00545532|Secondary|Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||Liter (L)|||Number
1245074|NCT00545532|Secondary|Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||L/hr|||Number
1245075|NCT00545532|Secondary|Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||1/hr|||Number
1245076|NCT00545532|Secondary|Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children|Reported here are oseltamivir Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||Liter (L)|||Number
1245077|NCT00545532|Secondary|Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children|Reported here are oseltamivir CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||L/hr|||Number
1245078|NCT00545532|Secondary|Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children|Reported here are oseltamivir ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||1/hr|||Number
1245079|NCT00545532|Secondary|Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate tmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||hour|||Number
1245080|NCT00545532|Secondary|Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children|AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir carboxylate AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng*hr/mL|||Number
1245081|NCT00545532|Secondary|Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL|||Number
1245082|NCT00545532|Secondary|Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL|||Number
1245084|NCT00545532|Secondary|Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children|AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose|The PKEP population comprised all subjects in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng*hr/mL|||Number
1245085|NCT00545532|Secondary|Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children|Reported here are oseltamivir Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL|||Number
1245086|NCT00545532|Secondary|Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children|Reported here are oseltamivir Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL|||Number
1245087|NCT00545532|Secondary|Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate Vc/F data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||liter (L)||Standard Deviation|Mean
1245088|NCT00545532|Secondary|Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate CL/F data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||L/hr||Standard Deviation|Mean
1245089|NCT00545532|Secondary|Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults|Reported here are oxeltamivir carboxylate ke data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||1/hr||Standard Deviation|Mean
1245090|NCT00545532|Secondary|Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate tmax data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||hour||Standard Deviation|Mean
1245091|NCT00545532|Secondary|Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate AUC0-12 data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all particiants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng*hr/mL||Standard Deviation|Mean
1245092|NCT00545532|Secondary|Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate Ctrough data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL||Standard Deviation|Mean
1245093|NCT00545532|Secondary|Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate Cmax data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL||Standard Deviation|Mean
1245094|NCT00545532|Secondary|Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults|Reported here are oseltamivir Vc/F data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||liter (L)||Standard Deviation|Mean
1245095|NCT00545532|Secondary|Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults|Reported here are oseltamivir CL/F data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||liter/hour (L/hr)||Standard Deviation|Mean
1245096|NCT00545532|Secondary|Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults|Reported here are oseltamivir ke data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||1/hr||Standard Deviation|Mean
1245097|NCT00545532|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults|Reported here are oseltamivir tmax data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||hour||Standard Deviation|Mean
1245159|NCT00545233|Secondary|Percentage of Participants Achieving Virologic Response|Virologic response was defined as undetectable HCV RNA < 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders.|Weeks 4, 12, 24, 48, 60, 72|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment.|||Percentage of Participants|||Number
1245098|NCT00545532|Secondary|Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults|AUC0-12 was reported at steady state as nanograms per hour per milliliter. (ng*hr/mL). Reported here are oseltamivir AUC0-12 data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng*hr/mL||Standard Deviation|Mean
1245099|NCT00545532|Secondary|Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults|Reported here are oseltamivir Ctrough data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL||Standard Deviation|Mean
1245100|NCT00545532|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults|Reported here are oseltamivir Cmax data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The pharmacokinetic evaluable patient (PKEP) population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1245101|NCT00545532|Secondary|Duration of Hospitalization|Reported is the duration of hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|The ITTi population included all participants randomized and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||days||Full Range|Median
1245102|NCT00545532|Secondary|Percentage of Participants Hospitalized|Reported is the percentage of participants, who required hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|The ITTi population included all participants randomized and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
1245103|NCT00545532|Secondary|Percentage of Participants Who Initiated Antibiotic Treatment|Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with secondary illness, who initiated antibiotic treatment, in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.|||percentage of participants|||Number
1245104|NCT00545532|Secondary|Percentage of Participants Who Developed Secondary Illness|Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with at least one event in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
1245105|NCT00545532|Secondary|Percentage of Participants With Persistent Viral Shedding|Persistent shedding was defined as a viral load reduction <1 log10 vp/mL at end of treatment compared with baseline. Reported is the percentage of participants with persistent viral shedding at end of treatment in adults >/= 18 years and adolescents and children < 18 years.|Baseline to Day 11 (EOT)|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
1245106|NCT00545532|Secondary|Time to Cessation of Viral Shedding by RT-PCR|Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||hours||95% Confidence Interval|Median
1245107|NCT00545532|Secondary|Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time|Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the percentage of subjects with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.|Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
1245108|NCT00545532|Secondary|Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)|Nasopharyngeal swab samples were tested for influenza A and B RNA using semi-quantitative RT-PCR specific for influenza A and B matrix gene, respectively, after viral RNA isolation. Cycle threshold (Ct) value was determined for each sample. Conversion of Ct values into viral load, expressed as log10 virus particles/mL (vp/mL), was obtained using external standard curves ran in parallel in all RT-PCR experiments. A value of < 2.6 log10 vp/mL for Flu A strains and < 3.0 log10 vp/mL for Flu B strains was interpreted as a negative result. Data are reported for adults >/= 18 years and adolescents and children < 18 years.|Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||log10 vp/mL||Full Range|Median
1245109|NCT00545532|Secondary|Time to Cessation of Viral Shedding by Cell Culture|Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||hours||95% Confidence Interval|Median
1245110|NCT00545532|Secondary|Percentage of Participants With Viral Shedding Assessed by Culture Over Time|Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the percentage of participants with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.|Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
1245111|NCT00545532|Secondary|Change From Baseline in Viral Load Assessed by Culture|Nasopharyngeal swab samples were cultured in Madin-Darby Canine Kidney cells. Culture supernatants were harvested after 2 weeks, or after a full-blown cytopathic effect was observed. Presence of infectious viruses in the cell culture supernatants (viral titer), expressed as log10 50% Tissue Culture Infectious Dose/milliliter (TCID50/mL), was determined by hemagglutination assay using turkey erythrocytes for H1 and B viruses or by detection of the virus nucleoprotein (NP) using ELISA for H3 viruses. A value of < 0.5 log10 TCID50/mL was interpreted as negative. Data are reported for adults >/= 18 years and adolescents and children < 18 years.|Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||TCID50/mL||Full Range|Median
1245112|NCT00545532|Secondary|Time to Resolution of Fever|Fever was defined as temperature >/= 37.8 degrees Celsius at any time point during the study. TTR of fever was determined in Adults >/= 18 years, Adults and adolescents >/= 13 years and Children < 13 years of the mITTi population.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||hours||95% Confidence Interval|Median
1245113|NCT00545532|Secondary|Total Symptom Score Area Under the Efficacy Curve (AUE)|The overall extent and severity of illness was quantified by the AUE of the total symptom scores over the duration of illness, i.e., from the start of treatment to the time symptoms first alleviated. Total symptom scores were calculated from the sum of seven individual symptom scores with each individual symptom scored from 0 (healthy) to 3 (worst sickness) and a maximum total symptom score of 21. The AUE of these average scores was then calculated for each participant using the trapezoidal rule (the trapezoidal rule calculates the area under any curve by adding up all trapezoids under such a curve). A larger area indicates more severe disease. In this study participants were treated for 10 days. If a participant had scored 21 on every visit then AUE would have been 21 score x 10 days x 24 hours/day =5040 score x hours units, which is the highest possible score. The lowest possible score is 0. Reported are results for adults >/= 18 years in the mITTi population.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||score * hour||Full Range|Median
1245114|NCT00545532|Secondary|Time to Resolution (TTR) of All Clinical Influenza Symptoms|TTR of all clinical influenza symptoms was defined as the time from treatment initiation to the start of the 24-hour period in which all 7 influenza symptoms had scores </= 1 (mild) and remained </=1 for at least 21.5 hours. . Reported are TTRs in adults >/= 18 years, adults and adolescents >/= 13 years and children <13 years in the mITTi population.|Baseline up to Day 40|mITTi: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline, and for whom data were available.|||hours||95% Confidence Interval|Median
1245115|NCT00545532|Primary|Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD)|The percentage of transplant patients in the safety population who experienced tissue rejection and/or GvHD is reported.|Baseline up to Day 40|The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.|||percentage of participants|||Number
1245116|NCT00545532|Primary|Percentage of Participants Who Developed Viral Resistance to Oseltamivir|Resistance was defined as the presence of oseltamivir resistance mutations in viruses isolated from nasopharyngeal swab samples, identified by sequencing of the neuraminidase (NA) and hemagglutinin (HA) genes (genotypic resistance) and/or determination of the oseltamivir concentration at which the response is reduced by half (IC50) in an NA inhibition assay (phenotypic resistance). Reported are post-baseline phenotypic and genotypic resistance in adults >/= 18 years and children and adolescents <18 years in the modified Intent-to-Treat infected (mITTi) population.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
1245577|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population||Week 26|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1245117|NCT00545532|Primary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to Day 40|The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.|||percentage of participants|||Number
1245118|NCT00545506|Primary|Tissue Oxygen Tension in the Sternal Wound|Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision.|8 hours||||mmHG|||Number
1245119|NCT00545506|Primary|Tissue Oxygenation Levels||2 years||2009-11-30|11/2009||||
1245120|NCT00545441|Primary|Healing Success|Healing was defined as “closure of external opening with absence of abscess, drainage and pain.”|12 months|Patients that were lost to follow-up, withdrew, or not treated were not included in the analysis. In the Surgisis arm, there were 9 patients lost to follow-up, 1 patient withdrew, and 1 patient not treated; in the Flap arm, there were 5 patients lost to follow-up, 1 patient withdrew, and 3 patients not treated.|||participants|||Number
1245121|NCT00545402|Secondary|Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review|The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population; only participants with evaluable biopsies were included in the analysis.|||percentage of participants|||Number
1245122|NCT00545402|Secondary|Overall Survival at Month 12|The median time, in months, between randomization and OS event. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population|||months||Full Range|Median
1245123|NCT00545402|Secondary|Overall Survival (OS) at Month 12 - Percentage of Participants With an Event|OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population|||percentage of participants|||Number
1245124|NCT00545402|Secondary|Graft Survival|The median time, in months, between randomization and graft loss event. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.|ITT population|||months||Full Range|Median
1245125|NCT00545402|Secondary|Percentage of Participants With Graft Loss|Graft survival was defined as the time between the randomization date and the graft loss date. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.|ITT population|||percentage of participants|||Number
1245126|NCT00545402|Primary|Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant|Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment|ITT population|||percentage of participants|||Number
1245127|NCT00545363|Secondary|Percent Change From Baseline in CTX Based on Adherence to Ibandronate|Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of ‘drug dispensed’ and ‘drug returned’ on CRF and participant’s self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.|Baseline, Month 6|"ITT population. Number of participants analyzed = participants evaluable for this outcome and n represents number of participants analyzed for the specified category."|||percent change||95% Confidence Interval|Least Squares Mean
1245128|NCT00545363|Secondary|Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score|OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.|At Month 6|ITT population. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
1245129|NCT00545363|Secondary|Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores|The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score.|At Month 6|ITT population. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
1245130|NCT00545363|Primary|Percentage of Participants With Adherence to Treatment|Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of ‘drug dispensed’ and ‘drug returned’ on case report form (CRF) and participant’s self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.|Up to 6 months|Intent to treat (ITT) population included all randomized participants. Number of participants analyzed=number of participants evaluable for this outcome.|||percentage of participants|||Number
1245131|NCT00545298|Primary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|All reported adverse events, related or unrelated to the study drug.|up to 24 weeks|All enrolled subjects, 4 in total|||number of events|||Number
1245132|NCT00545298|Primary|Wound Healing|% Re-epithelialization|Week 20|Per protocol. Only one subject met the 20 week time point. All other subjects withdrew early from the study and did not reach the Week 20 time point|||% re-epithelialization|||Number
1245133|NCT00545272|Secondary|Number of Participants Using Rescue Medication|Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.|Over 14 days|Intent to treat|||participants|||Number
1245134|NCT00545272|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow|The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter and recorded measurements in a diary every morning and evening during the study, prior to taking study medication. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.|Baseline (recorded during the screening period) and Days 1-14 (treatment period)|"Intent to treat population. The analysis only includes patients with non-missing data, indicated by N."|||liters/minute||Standard Deviation|Mean
1245135|NCT00545272|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.|Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose|"The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by N."|||minutes||Standard Deviation|Mean
1245136|NCT00545272|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1|FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.|||liters||Standard Error|Least Squares Mean
1245137|NCT00545272|Secondary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1 Baseline (prior to first dose) and 24 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.|||liters||Standard Error|Least Squares Mean
1245138|NCT00545272|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose|FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.|||liters||Standard Error|Least Squares Mean
1245139|NCT00545272|Primary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Baseline (prior to first dose) and Day 15 (24 hours after last dose)|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.|||liters||Standard Error|Least Squares Mean
1245174|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)|Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.|Upon testing by EMS.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
1245175|NCT00545103|Secondary|Percent of Subjects Requiring Surgery for Diverticulitis||up to 104 Weeks|Full Analysis Set|||percentage of subjects|||Number
1245140|NCT00545233|Secondary|Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed|The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression.|Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Safety population who received at least one dose of study drug and who had data available at the given time point for analysis.|||Percentage of Participants|||Number
1245141|NCT00545233|Secondary|Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed|"Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
1245142|NCT00545233|Secondary|Change From Baseline in Leptin Levels at Each Time Point Assessed|"Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||ng/mL||Standard Error|Mean
1245143|NCT00545233|Secondary|Change From Baseline in Adiponectin Levels at Each Time Point Assessed|"Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||μg/mL||Standard Error|Mean
1245144|NCT00545233|Secondary|Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed|"Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||pg/mL||Standard Error|Mean
1245145|NCT00545233|Secondary|Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed|"Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||pg/mL||Standard Error|Mean
1245146|NCT00545233|Secondary|Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
1245147|NCT00545233|Secondary|Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
1245148|NCT00545233|Secondary|Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
1245230|NCT00544674|Secondary|Time to Progression|Time to progression (TTP) was defined as the time from date of registration to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From registration of the first subject until radiological progression or recurrence whichever came first|||||||
1245149|NCT00545233|Secondary|Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed|"Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
1245150|NCT00545233|Secondary|Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed|"Insulin resistance (IR) is calculated using the following formula:~HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405.~Baseline for with pioglitazone arm occurred prior to the start of 16 week run-in period and for without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated.~A normal patient can have a HOMA score up to 3. A patient with a score of >3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||HOMA Score||Standard Error|Mean
1245151|NCT00545233|Secondary|Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed|"Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||Percent||Standard Error|Mean
1245152|NCT00545233|Secondary|Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.|"Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||pmol/L||Standard Error|Mean
1245153|NCT00545233|Secondary|Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed|"Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
1245154|NCT00545233|Secondary|Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only|Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated.|Randomization (Week-16),Weeks -12, -8, -4 and 0|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||IU/mL||Standard Error|Mean
1245155|NCT00545233|Secondary|Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period|Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment|Up to 48 Weeks|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||Percentage of Participants|||Number
1245156|NCT00545233|Secondary|Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks|Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA.|Up to 48 Weeks|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||Percentage of Participants|||Number
1245157|NCT00545233|Secondary|Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)|Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy.|Week 72|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||Percentage of Participants|||Number
1245158|NCT00545233|Secondary|Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72|Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated.|Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72|Intent-to Treat population included all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||Percentage of Participants|||Number
1245578|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245160|NCT00545233|Secondary|Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy|Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.|Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.|||IU/mL||Standard Error|Mean
1245161|NCT00545233|Primary|Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy|Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.|Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.|||IU/mL||Standard Error|Mean
1245162|NCT00545181|Primary|Recurrent Bacterial Vaginosis|Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.|3 months||||Participants|||Number
1245163|NCT00545168|Primary|Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice|The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).|Assessment were made 14 days following the final product treatment|Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.|||participants|||Number
1245164|NCT00545168|Secondary|Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.|To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|480 subjects were randomized to treatment and 469 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. Thus subjects used 1 or 2 treatments.|||Incidents|||Number
1245165|NCT00545155|Primary|Concurrent Criterion Validity of PHQ-2|"This is the PHQ-2, a test for depression (scoring=yes or no) as compared to the PHQ-9, a test for depression (scoring=yes or no), looking at the presence of depression.~This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice)."|2 hours||||kappa||95% Confidence Interval|Number
1245166|NCT00545155|Primary|Test-Retest Reliability Testing of PHQ-2 Screening|The test for depression, using the PHQ-2, with scoring yes or no.|2 hours||||kappa||95% Confidence Interval|Number
1245167|NCT00545155|Primary|Proportion of Subjects Depressed in the ED|Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.|Within 2 hours of EMS testing|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
1245168|NCT00545155|Primary|Proportion of Subjects Depressed in the ED|Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.|Within 2 hours of EMS testing.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
1245169|NCT00545155|Primary|Proportion of Subjects Depressed in EMS.|Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel|Upon testing by EMS.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
1245170|NCT00545155|Primary|Concurrent Criterion Validity of Six Item Screener Screening|"This is the Six Item Screener test for cognitive impairment (scoring=yes or no), as compared to performing the Mini-Cog for cognitive impairment (scoring=yes or no) on patients immediately afterwards.~This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice)."|2 hours||||kappa||95% Confidence Interval|Number
1245171|NCT00545155|Primary|Test-Retest Reliability of Six Item Screener Screening|The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.|2 hours|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||kappa||95% Confidence Interval|Number
1245172|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in the ED|Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel.|Within 2 hours of testing by EMS|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
1245173|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)|Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED.|Within 2 hours of testing by EMS.|All of the subjects enrolled who completed all aspects of the testing.|||percentage of subjects|||Number
1245176|NCT00545103|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT Scans|||Number
1245177|NCT00545103|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT Scans|||Number
1245178|NCT00545103|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT Scans|||Number
1245179|NCT00545103|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 Weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT Scans|||Number
1245180|NCT00545103|Secondary|Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis|CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.|up to 104 weeks|Full Analysis Set|||percentage of subjects|||Number
1245181|NCT00545103|Primary|Percent of Subjects Without Recurrence of Diverticulitis|Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.|up to 104 Weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.|||percentage of subjects|||Number
1245182|NCT00545064|Other Pre-specified|Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol|IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value.|Baseline to Week 4 and from Baseline to Week 8|176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on IOP were available for 164 and 166 patients at week 4 and 8 respectively|||mm Hg||Standard Deviation|Mean
1245183|NCT00545064|Other Pre-specified|Physician’s Global Satisfaction|At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient’s treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.|Week 8|178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).|||Participants|||Number
1245184|NCT00545064|Other Pre-specified|Patient’s Global Satisfaction|At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.|Week 8|178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).|||Participants|||Number
1245185|NCT00545064|Primary|Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score|GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline.|Baseline to week 8|176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on GSS-SYMP-6 were available for 114 and 111 patients at week 4 and 8 respectively|||Units on a Scale||Standard Deviation|Mean
1245186|NCT00545051|Secondary|Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months|Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.|Month 6|ITT population|||percentage of participants|||Number
1245187|NCT00545051|Secondary|Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12|Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.|Baseline and Months 1, 6 and 12|ITT population; n=number of participants analyzed at the specified visit for the given parameter.|||percent change in bone turnover markers||Standard Deviation|Mean
1245200|NCT00544908|Primary|Progression-free Survival (PFS) Rate at 4 Months|Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).|Four months.||||percentage of participants|||Number
1245188|NCT00545051|Secondary|Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12|Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.|Baseline and Months 6 and 12|ITT population; number (n) equals (=) number of participants analyzed at the specified visit.|||percent change in BMD||Standard Deviation|Mean
1245189|NCT00545051|Secondary|Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6|Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.|Baseline and Month 6|ITT Population|||percent change in BMD||Standard Deviation|Mean
1245190|NCT00545051|Primary|Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12|Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.|Baseline and Month 12|Intent-to-treat (ITT) population|||percent change in BMD||Standard Deviation|Mean
1245191|NCT00545025|Secondary|Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1245192|NCT00545025|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 0 and 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.|||Subjects|||Number
1245193|NCT00545025|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.|||Subjects|||Number
1245194|NCT00545025|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10.|At Days 0 and 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.|||Titer||95% Confidence Interval|Geometric Mean
1245195|NCT00545025|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-30)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1245196|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.|During a 30-day (Days 0-29) follow-up period after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1245197|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During a 7-day (Days 0-6) follow-up after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1245198|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.|During a 7-day (Days 0-6) follow-up period after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1245199|NCT00544908|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After every two cycles, up to 5 years||||percentage of participants|||Number
1245426|NCT00542750|Primary|Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period|Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.|one year||||Participants|||Number
1245202|NCT00544882|Secondary|Number of Days of Bleeding During Unscheduled and Scheduled Study Periods|The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat|||days||Standard Deviation|Mean
1245203|NCT00544882|Secondary|Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods|The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat|||percentage of participants|||Number
1245204|NCT00544882|Secondary|Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods|The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat|||days||Standard Deviation|Mean
1245205|NCT00544882|Secondary|Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size|The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.|Cycle 2, Days 1-20 and Cycle 2, Days 21-28|Intent-to-treat population with available data.|||mm||Standard Deviation|Mean
1245206|NCT00544882|Primary|Serum Inhibin-B Levels by Cycle Day|Levels of inhibin-B were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).|||pg/mL||Full Range|Median
1245207|NCT00544882|Primary|Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day|Levels of follicle stimulating hormone were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).|||mIU/mL||Full Range|Median
1245208|NCT00544882|Secondary|Percentage of Follicles Greater Than 5 mm in Diameter|Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).|Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.|Intent-to-treat|||percentage of follicles|||Number
1245209|NCT00544882|Primary|Serum Estradiol Levels by Cycle Day|Levels of estradiol were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).|||pg/mL||Full Range|Median
1245210|NCT00544869|Primary|Body Weight|The change of body weight from baseline at final observation|Baseline, Day 14 or at the time of final drug administration||||Kg||Standard Deviation|Mean
1245211|NCT00544817|Secondary|Objective Response|"The number of patients with complete or partial responses measured from the time of initial response to documented tumor progression. Radiologic response was defined using the Macdonald criteria.~The Macdonald criteria divides response into 4 types of response based on imaging (MRI) and clinical features, as follows: 1) complete response (CR); 2) partial response (PR); 3) stable disease (SD); and 4) progression (PD).~Criteria:~CR: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions. No corticosteroids, clinically stable or improved.~PR: >=50% decrease of all measurable enhancing lesions, sustained for at least 4 weeks, no new lesions. Stable or reduced corticosteroids, clinically stable or improved.~SD: does not qualify for complete response, partial response or progression. Clinically stable.~PD: >= 25% increase in enhancing lesions, any new lesions. Clinical deterioration."|every 8 weeks until disease progression, estimated 18 months||||participants|||Number
1245212|NCT00544817|Secondary|Overall Survival|Defined as Day 1 of protocol treatment to date of death from any cause.|18 months||||Months||95% Confidence Interval|Median
1245213|NCT00544817|Primary|Progression-free Survival|Defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|18 months||||Months||95% Confidence Interval|Median
1245214|NCT00544778|Primary|Response Rate|Response rate defined as the proportion of subjects with confirmed partial or complete response as defined by the RECIST criteria.|First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years.||||percentage of patients responding|||Number
1245215|NCT00544713|Secondary|Change From Baseline in Study Product Usage at Day 90|Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement).|Baseline, Day 90|Intent-to-Treat includes all patients that started the study and were randomized. Only those patients who reported actual eye drop use at Baseline and on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in arm 1 who reported eye drop use/number of patients in arm 2 who reported eye drop use).|||Number of study product uses per day||Standard Deviation|Mean
1245216|NCT00544713|Other Pre-specified|Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60|Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day.|Day 14, Day 60|Intent to Treat includes all patients that started the study and were randomized. Only those patients who were prescribed a dosing regimen at Day 14 to Day 60 visits were analyzed. The is indicated in parenthesis as (number of patients in arm 1 who were prescribed/number of patients in arm 2 who were prescribed).|||Number of patients|||Number
1245217|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90|Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Number of seconds||Standard Deviation|Mean
1245218|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90|Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Scores on a Scale||Standard Deviation|Mean
1245219|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90|Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 90|Intent to Treat population defined as all patients who started the study and were randomized|||Scores on a Scale||Standard Deviation|Mean
1245220|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Schirmer's Test at Day 90|Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Millimeters of Tears||Standard Deviation|Mean
1245221|NCT00544713|Secondary|Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90|Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Microns||Standard Deviation|Mean
1245222|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90|Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Units on a scale||Standard Deviation|Mean
1245223|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90|Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Units on a scale||Standard Deviation|Mean
1245224|NCT00544713|Secondary|Best Corrected Visual Acuity (BCVA) Status at Day 90|"BCVA status at Day 90 reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more; No Change equals change between -2 to +2 lines; Worse equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly."|Day 90|Intent to Treat includes all patients who started the study and were randomized. One patient's status in the first arm was not available at Day 90 and was not evaluated for this outcome measure therefore only 113 patients were analyzed for this outcome measure.|||Number of Patients|||Number
1245225|NCT00544713|Secondary|Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90|"A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree."|Day 90|Intent to Treat includes all patients who started the study and were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).|||Percentage of Patients|||Number
1245226|NCT00544713|Secondary|Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90|"A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree."|Day 90|Intent to Treat includes all patients who started the study are were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).|||Percentage of Patients|||Number
1245227|NCT00544713|Primary|Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90|Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).|Day 90|Intent to Treat population defined as all patients who started the study and were randomized|||Scores on a Scale||Standard Deviation|Mean
1245228|NCT00544674|Secondary|Pharmacokinetics||Days 1 and 2 of Cycles 1 and 4|||||||
1245229|NCT00544674|Primary|Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following the last administration of study treatment||||participants|||Number
1245231|NCT00544674|Secondary|Progression-free Survival|Progression free survival (PFS) is the time (days) from date of registration to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented.|Tumor measurements and assessments based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria were performed 6 weeks after first dose and as dictated by subject's malignancy|||||||
1245232|NCT00544674|Secondary|Survival||Every 3 months for 2 years after discontinuation|||||||
1245233|NCT00544674|Primary|Response Rate (Complete or Partial)||From registration until disease progression/recurrence|||||||
1245234|NCT00544648|Other Pre-specified|Secreted Protein Acidic and Rich in Cysteine (SPARC) Gene Expression|Secreted protein acidic and rich in cysteine (SPARC) gene expression in tumor specimens.|On receipt of tumor tissue blocks|Investigators elected not to perform this analysis.||||||
1245235|NCT00544648|Secondary|Response (Phase II)|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing (n = 0) or if the patient is non-evaluable for best overall response (n = 1)|||participants|||Number
1245236|NCT00544648|Secondary|Number of Patients With Each Worst Grade Toxicity (Phase II)|The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death|at 16 weeks|Treated patients who experienced a toxicity.|||participants|||Number
1245237|NCT00544648|Secondary|Overall Survival (Phase II)|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details. Too few patients were enrolled in the Phase II arm for an analysis of overall survival|Time Frame: date on study to date of death from any cause or last known date alive|Too few patients were enrolled in the Phase II arm for an analysis of overall survival||||||
1245238|NCT00544648|Secondary|Number of Patients With Each Worst Grade Toxicity (Phase I)|Count of patients according to the worst-grade toxicity (WGT) experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death.|On-study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity. One patient did not experience toxicity.|||participants|||Number
1245239|NCT00544648|Secondary|Response (Phase I)|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing (0) or if the patient is non-evaluable for best overall response (n = 1)|||participants|||Number
1245240|NCT00544648|Secondary|Overall Survival (Phase I)|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).|On-study date to date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.|||days||95% Confidence Interval|Median
1245241|NCT00544648|Secondary|Progression-free Survival (Phase I)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.|||days||95% Confidence Interval|Median
1245242|NCT00544648|Primary|Progression-free Survival (Phase II)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.|||days||95% Confidence Interval|Median
1245260|NCT00544557|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 52|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||minutes||Standard Deviation|Mean
1245579|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population||Week 104|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1245243|NCT00544648|Primary|Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I)|The highest dose in milligrams per meter of body surface squared (mg/m2) of nab-paclitaxel in combination with carboplatin while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of nab-paclitaxel in combination with carboplatin until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs per Common Toxicity Criteria v 3.0: recurring non-hematological (except esophagitis) > Grade 2, non-hematological or esophagitis > Grade 3 toxicities that are symptomatically unacceptable to patient and result in treatment delay for > 2 weeks, persistent toxicity resulting in treatment delay for > 2 weeks.|7 weeks|MTD based on clinical performance of those patients who received the study drug. One patient withdrew before receiving treatment. No formal statistical analysis, such as hypothesis testing, was performed.|||mg/m2|||Number
1245244|NCT00544557|Secondary|Percentage of Participants With Discontinuation of Treatment Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 52|Safety population included all treated participants with available post­-baseline safety data.|||percentage of participants|||Number
1245245|NCT00544557|Secondary|Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis|Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.|Baseline up to Week 52|Safety population included all treated participants with available post-baseline safety data.|||percentage of participants|||Number
1245246|NCT00544557|Secondary|Duration of Healthcare Resources Utilization|Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants’ healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||days||Standard Deviation|Mean
1245247|NCT00544557|Secondary|Healthcare Resource Utilization|Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants’ healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||events||Standard Deviation|Mean
1245248|NCT00544557|Secondary|Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)|WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||percentage of impairment||Standard Deviation|Mean
1245249|NCT00544557|Secondary|Euro Quality of Life (EQ­-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
1245250|NCT00544557|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self­care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
1245374|NCT00543140|Secondary|Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.|The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.|||percentage||95% Confidence Interval|Mean
1245251|NCT00544557|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (>=) 40 percent improvement from baseline and an absolute change >=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0–10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.|Week 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants||95% Confidence Interval|Number
1245252|NCT00544557|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response|ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least >= 20 percent improvement from baseline and an absolute change >=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0–10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.|Week 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants||95% Confidence Interval|Number
1245253|NCT00544557|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||mm/hr||Standard Deviation|Mean
1245254|NCT00544557|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1245255|NCT00544557|Secondary|Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52|Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||body parts||Standard Deviation|Mean
1245256|NCT00544557|Secondary|Percentage of Participants With Presence of Enthesitis|Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants|||Number
1245257|NCT00544557|Secondary|Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52|Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||joints||Standard Deviation|Mean
1245258|NCT00544557|Secondary|Percentage of Participants With Presence of Peripheral Arthritis|Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants|||Number
1245259|NCT00544557|Secondary|Percentage of Participants With Significant Reduction of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness).|Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants|||Number
1245261|NCT00544557|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52|Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
1245262|NCT00544557|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52|Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
1245263|NCT00544557|Secondary|Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52|Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
1245264|NCT00544557|Secondary|Change From Baseline in Lateral Lumbar Flexion at Week 52|Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||cm||Standard Deviation|Mean
1245265|NCT00544557|Secondary|Change From Baseline in Occiput-to-Wall Distance at Week 52|Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘n' signifies participants evaluable for this measure at given time points.|||centimeter (cm)||Standard Deviation|Mean
1245266|NCT00544557|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0–10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0–10).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
1245267|NCT00544557|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52|BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0–10 BASDAI score (0 being no problem and 10 being the worst problem).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
1245268|NCT00544557|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity||Baseline up to Week 52|Safety population included all treated participants with available post­-baseline safety data.|||percentage of participants|||Number
1245269|NCT00544557|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non­-SAEs.|Baseline up to Week 52|Safety population included all treated participants with available post-baseline safety data.|||percentage of participants|||Number
1245270|NCT00544557|Primary|Percentage of Participants Achieving Partial Remission at Week 52|Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.|Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1245287|NCT00543855|Primary|Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)|"NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and every 4 weeks up to 12 weeks|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.|||Score on a scale||Standard Deviation|Mean
1245271|NCT00544557|Primary|Percentage of Participants Achieving Partial Remission at Week 26|Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.|Week 26|Effectiveness population: all treated participants greater than or equal to (>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1245272|NCT00544544|Secondary|Clinical Global Impression Scale|The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (week 0) - week 6||||units on a scale||95% Confidence Interval|Mean
1245273|NCT00544544|Secondary|Young Mania Rating Scale|The Young Mania Rating Scale is a clinician-rated scale that measures the severity of mania symptoms. The 11 items measures are elevated mood, increased motor activity, sexual interest, sleep, irritability, speech, language-thought disorder, thought content, aggressive behavior, appearance, and insight. Minimum score is zero and maximum score is 60. Higher scores represent more severe mania symptoms.|Baseline (week 0) - week 6||||units on a scale||95% Confidence Interval|Mean
1245274|NCT00544544|Secondary|Montgomery Asberg Depression Rating Scale|The Montgomery-Asberg Depression Rating Scale is a clinician-rated scale that measures the severity of depression symptoms. The 10 items measured are apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Minimum score is zero and maximum score is 60. Higher scores represent more severe depressive symptoms.|Baseline (week 0) - week 6||||units on a scale||95% Confidence Interval|Mean
1245275|NCT00544544|Primary|Change in Hamilton Depression Rating Scale|The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. Minimum score is zero and maximum score is 65. Higher scores indicate more severe depressive symptoms.|Baseline (week 0) - week 6||||units on a scale||95% Confidence Interval|Mean
1245276|NCT00544440|Secondary|Number of Participants With Change in Markers of Bone Metabolism||Week 8|Data was reported in individual participant listings but not summarized due to statistical constraints.||||||
1245277|NCT00544440|Primary|Difference in Bone Marrow Testosterone Levels Between Participants With and Without Serum Prostate Specific Antigen Decline||Week 8|Since there were too few participants with any detectable bone marrow testosterone, this analysis was not performed.||||||
1245278|NCT00544440|Primary|Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)||Baseline (predose Week 1 Day 1) and Week 8|Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.|||Number of Participants|||Number
1245279|NCT00544440|Primary|Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)||Baseline (predose Week 1 Day 1) and Week 8|Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.|||Number of Participants|||Number
1245280|NCT00544167|Primary|The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.||18 Months||||percentage of patients|||Number
1245281|NCT00543985|Secondary|Change in Maximal Oxygen Uptake (VO2 Max)|Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min) Measured in all participants immediately following treadmill stress test.|12 weeks|This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.||||||
1245282|NCT00543985|Secondary|Mean Resting Maximal Oxygen Uptake (VO2 Max)|Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min). Measured in all participants prior to treadmill stress test.|12 weeks|This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.||||||
1245283|NCT00543985|Primary|Post-exercise E/E'|E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants immediately following treadmill stress test.|12 weeks|The echo results from all subjects were analyzed at rest and following maximal exercise testing.|||ml/min/kg||Standard Error|Mean
1245284|NCT00543985|Primary|Mean Resting E/E'|E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants prior to treadmill stress test.|12 weeks|The echo results from all subjects were analyzed at rest and following maximal exercise testing.|||ml/min/kg||Standard Error|Mean
1245285|NCT00543855|Primary|Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)|"J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.~ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and Week 12|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.|||Score on a scale||Standard Deviation|Mean
1245286|NCT00543855|Primary|Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)|"CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from markedly improved” to “markedly worse”. Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and week 12|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.|||Percentage of Participants|||Number
1245288|NCT00543855|Primary|Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.|Baseline and every 4 weeks up to 12 weeks|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.|||Score on a scale||Standard Deviation|Mean
1245289|NCT00543803|Secondary|Investigator's Global Clinical Assessment of Patient General Health Status|Investigators opinion of patients general health condition at baseline versus last evaluation on treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||participants|||Number
1245290|NCT00543803|Secondary|Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator|Total number of patients with investigator defined non-serious drug-related AEs was reported.|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||participants|||Number
1245291|NCT00543803|Secondary|Summary of Change From Baseline in CD4+ Count to Last Value on Treatment||from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||(cells) / mm^3||Inter-Quartile Range|Median
1245292|NCT00543803|Secondary|Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment|For calculation of this measure switch patients are included in the total which had no viral load decrease.|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||(log10 copies) / ml||Inter-Quartile Range|Median
1245293|NCT00543803|Primary|Summary of Change From Baseline in Glucose to Last Value on Treatment|The change in Glucose from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
1245294|NCT00543803|Primary|Summary of Change From Baseline in Triglycerides to Last Value on Treatment|The change in triglycerides from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
1245295|NCT00543803|Primary|Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment|The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
1245296|NCT00543803|Primary|Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment|The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
1245297|NCT00543803|Primary|Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment|The change in total cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
1245298|NCT00543803|Primary|Summary of Change From Baseline in Creatinine to Last Value on Treatment|The change in Creatinine from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
1245299|NCT00543803|Primary|Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment|The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||IU/L||Inter-Quartile Range|Median
1245300|NCT00543803|Primary|Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment|The change in asparate aminotransferase (AST) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||IU/L||Inter-Quartile Range|Median
1245301|NCT00543803|Primary|Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment|The change in alanine aminotransferase (ALT) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||IU/L||Inter-Quartile Range|Median
1245302|NCT00543764|Primary|Operative Time|Length of Time in surgery|3 years||||hours||95% Confidence Interval|Mean
1245303|NCT00543725|Secondary|Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 96|"The Intent-to-Treat analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome."|||Participants|||Number
1245304|NCT00543725|Secondary|Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline, Week 48, and Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||cells per microliter||95% Confidence Interval|Mean
1245305|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96|Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 96. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).|Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245306|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48|Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245307|NCT00543725|Secondary|Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).|Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per mL at the last on-treatment post-Week 96 visit.|Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz|Participants with at least 1 Post-Week 96 visit were included in the analysis.|||Participants|||Number
1245308|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245309|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245310|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48|The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/mL (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/mL in the Wk 48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/mL and subjects who had a switch in background regimen that was not permitted by the protocol.|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245311|NCT00543725|Primary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48|Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245312|NCT00543569|Secondary|Gastrointestinal Symptom Rating Scale Scores Over Time|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.|Months 1, 3, 6, and 12|"Full analysis set with available data at each time point (indicated by N)"|||units on a scale||Standard Deviation|Mean
1245313|NCT00543569|Secondary|Gastrointestinal Quality of Life Index Score Over Time|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.|Months 1, 3, 6, and 12|"Full analysis set with available data at each time point (indicated by N)"|||units on a scale||Standard Deviation|Mean
1245314|NCT00543569|Secondary|Percentage of Participants With Treatment Failure at Month 6 and 12|Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245315|NCT00543569|Secondary|Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12|All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245316|NCT00543569|Secondary|Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12|"Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol.~The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245318|NCT00543569|Secondary|Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review|"The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.~Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|6 months and 12 months|Full analysis set|||participants|||Number
1245319|NCT00543569|Secondary|Maximum Grade of T-cell Mediated Rejection Assessed by Local Review|"The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.~Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|6 months and 12 months|Full analysis set|||participants|||Number
1245320|NCT00543569|Secondary|Time to First T-cell Mediated BCAR Assessed by Central Review|The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.|12 months|Full analysis set with a T-cell mediated BCAR as assessed by the central reviewer|||days||Full Range|Median
1245321|NCT00543569|Secondary|Time to First T-cell Mediated BCAR Assessed by Local Review|The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.|12 months|Full analysis set with a T-cell mediated BCAR as assessed by local review|||days||Full Range|Median
1245322|NCT00543569|Secondary|Time to First BCAR Assessed by Central Review|The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.|12 months|Full analysis set with a BCAR as assessed by the central reviewer|||days||Full Range|Median
1245323|NCT00543569|Secondary|Time to First BCAR Assessed by Local Review|The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.|12 months|Full analysis set with a BCAR assessed by local review|||days||Full Range|Median
1245324|NCT00543569|Secondary|Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review|Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to central review, or lost to follow-up.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245325|NCT00543569|Secondary|Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review|Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to local review, or lost to follow-up.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245326|NCT00543569|Secondary|Change From Week 4 in Serum Creatinine at Month 6 and 12||Week 4 and Month 6 and 12|"Full analysis set with available data at Week 4. N indicates participants with available data at each time point."|||mg/dL||Standard Deviation|Mean
1245327|NCT00543569|Secondary|Change From Week 4 in GFR by Iothalamate Clearance at Month 6|The glomerular filtration rate was measured directly using iothalamate clearance.|Week 4 and Month 6|"Full analysis set with available data at Week 4. N indicates participants with available data at Week 4 and Month 6."|||mL/min per 1.73 m^2||Standard Deviation|Mean
1245328|NCT00543569|Secondary|Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12|The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.|Week 4, Month 6 and Month 12|"Full analysis set with available data at Week 4. N indicates the number of participants with available data at each time point."|||mL/min per 1.73 m^2||Standard Deviation|Mean
1245329|NCT00543569|Secondary|Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review|"Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245330|NCT00543569|Secondary|Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245331|NCT00543569|Secondary|Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review|"Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245332|NCT00543569|Secondary|Percentage of Participants With BCAR at Month 12 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245333|NCT00543569|Secondary|Graft Survival at Month 6 and Month 12|"Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245334|NCT00543569|Secondary|Patient Survival at Month 6 and Month 12|"Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245335|NCT00543569|Primary|Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
1245336|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 61: 28 days postdose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
1245337|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 60 + 1 week: Day 7 postdose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
1245338|NCT00543543|Secondary|Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.|4 weeks postdose 3|The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1 - Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range|||Percentage of participants||95% Confidence Interval|Number
1245339|NCT00543543|Secondary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Persistent Infection|Combined Incidence of HPV Type 31/33/45/52/58-related persistent infection as determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. Persistent infection was defined as infection detected in samples from >=2 consecutive visits 6 months (+/-1 month visit window) or longer apart. Incidence was defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.|Up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.|||Cases per 10,000 person-years follow-up|||Number
1245340|NCT00543543|Primary|Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event.|Up to Month 6|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
1245341|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. An AE that is judged by the investigator to be “definitely related,” “probably related,” or “possibly related” to the study drug is defined as a vaccine-related AE.|Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
1245493|NCT00542178|Secondary|Loss of Visual Acuity||Measured at Year 4|Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information about loss in visual acuity.|||Participants|||Count of Participants
1245342|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|Up to Day 15 after any vaccination|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
1245343|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Injection-site Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|Up to Day 5 after any vaccination|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
1245344|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
1245345|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 60: predose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
1245346|NCT00543543|Primary|Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.|4 weeks postdose 3 in the base study|The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
1245347|NCT00543543|Primary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)|HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.|Up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.|||Cases per 10,000 person-years follow-up|||Number
1245348|NCT00543543|Primary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)|HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.|From Day 1 until >=30 cases accumulate, up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.|||Cases per 10,000 person-years follow-up|||Number
1245349|NCT00543400|Primary|Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa Inhibitors and Bleeding.||30 days||||patients experiencing an event|||Number
1245371|NCT00543140|Secondary|Change in SF-36 Health Survey Mental Component at 5 Years Post Implant|Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.|||Unitless scale ranging 0 to 100||95% Confidence Interval|Mean
1245372|NCT00543140|Secondary|Change in SF-36 Health Survey Physical Component at 5 Years Post Implant|Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.|||unitless scale ranging 0 to 100||95% Confidence Interval|Mean
1245373|NCT00543140|Secondary|Percent Change in Excess Body Weight at 5 Years Post-implant||5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.|||percentage of excess body weight||95% Confidence Interval|Mean
1245350|NCT00543387|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were AEs considered related to study drug that prevented escalation of the drug dose. Hematologic DLTs included any Grade 5 hematologic toxicity, Grade 4 neutropenia lasting for ≥7 days in duration, Grade 3 or Grade 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and Grade 4 thrombocytopenia (≤25.0 x 10^9/L). Non-hematologic DLT was defined as any Grade 3, 4, or 5 non-hematologic toxicity, with the specific exceptions of: Grade 3 nausea or Grade 3 vomiting, Grade 3 diarrhea, or Grade 3 dehydration occurring in the setting of inadequate compliance with supportive care and lasting for <48 hours, alopecia, inadequately treated hypersensitivity reactions, or Grade 3 elevated transaminases of ≤1 week in duration. Any drug-related AE leading to a dose modification of MK-5108, or any unresolved drug-related toxicity persisting>6 weeks, was also considered a DLT.|Day 1 to Day 21 of study treatment (Cycle 1 for Panel 1, Panel 2, or Crossover)|All participants that received one or more doses of study medication. Participants who received MK-5108 monotherapy in Panel 1 and then crossed over to receive combination treatment in Panel 2 (Crossover) were included in both respective treatment groups and DLTs were reported according to treatment received.|||Participants|||Count of Participants
1245351|NCT00543387|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor’s product, was also an AE. The number of participants who experienced an AE was reported for each dose level group.|From Day 1 of study treatment until 30 days following the last dose of study treatment (up to 577 days)|All participants that received one or more doses of study medication. Four participants who received MK-5108 monotherapy in Panel 1 and then crossed over to receive combination treatment in Panel 2 (Crossover) were included in both respective treatment groups and AEs were reported according to treatment received.|||Participants|||Count of Participants
1245352|NCT00543309|Secondary|N-terminal Pro-brain Natriuretic Peptide Levels|N-terminal pro-brain natriuretic peptide levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.|Preoperative baseline to 24 hours after CICU admission||||fmol/mL||Full Range|Median
1245353|NCT00543309|Secondary|Epinephrine Levels|Plasma epinephrine levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.|Preoperative baseline to 24 hours after CICU admission||||ng/mL||Full Range|Median
1245354|NCT00543309|Secondary|Plasma Norepinephrine Levels.|Plasma norepinephrine levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.|Preoperative baseline to 24 hours after CICU admission||||ng/mL||Full Range|Median
1245355|NCT00543309|Secondary|Resource Utilization: Days Alive and Out of Hospital Within 180 Days of Surgery|Days the patient was alive and out of hospital within the 180 days after Fontan surgery|180 days||||days||Full Range|Median
1245356|NCT00543309|Secondary|Resource Utilization: Chest Tube Days|Days during which one or more chest tubes were in place following the Fontan operation.|From Fontan operation until final chest tube removed, assessed during postoperative hospitalization, up to 90 days.||||days||Full Range|Median
1245357|NCT00543309|Secondary|Resource Utilization: Days of Initial CICU Stay|Days of initial postoperative CICU care following the Fontan operation.|From Fontan operation until initial discharge from the CICU, assessed during the postoperative hospitalization, up to 90 days.||||days||Full Range|Median
1245358|NCT00543309|Secondary|Resource Utilization: Hours of Mechanical Ventilation Until Initial Extubation|Hours of mechanical ventilation until initial extubation following the Fontan operation.|From Fontan operation until initial extubation, assessed during initial CICU stay, up to 30 days.||||hours||Full Range|Median
1245359|NCT00543309|Secondary|Renal Function: Maximum Change in Serum Creatinine||14 days after surgery||||mg/dL||Full Range|Median
1245360|NCT00543309|Secondary|Renal Function: Urine Output|Volume of urine in mL/kg per day|first 24 hours CICU admit||||mL/kg per day||Full Range|Median
1245361|NCT00543309|Secondary|Cardiovascular: Peak Lactate Level||Initial 24 hours in CICU||||mEq/liter||Full Range|Median
1245362|NCT00543309|Secondary|Cardiovascular: Peak Inotrope Score|"Peak Inotrope Score = Doses of dopamine in mcg/kg/minute + dobutamine in mcg/kg/minute + (epinephrine in mcg/kg/minute x 100).~The lowest (best) possible Peak Inotrope Score = 0 dose equivalents. There is no maximum Peak Inotrope Score."|Initial 24 hours in CICU||||dose equivalents||Full Range|Median
1245363|NCT00543309|Secondary|Cardiovascular: Arrhythmia|arrhythmia lasting >30 seconds or requiring treatment|Postoperative day (POD) #0 through 5||||Participants|||Count of Participants
1245364|NCT00543309|Secondary|Cardiovascular: Cardiac Index|Cardiac index measured using Fick principle with measured oxygen consumption.|Postoperative hour #8|Study patients for whom cardiac index measurements were available.|||L/min/m2||Full Range|Median
1245365|NCT00543309|Secondary|Cardiovascular: Cardiac Index|Cardiac index measured using Fick principle with measured oxygen consumption.|Postoperative hour #1|Study patients for whom cardiac index measurements were available.|||L/min/m2||Full Range|Median
1245366|NCT00543309|Primary|Days Alive and Out of the Hospital Within 30 Days of Surgery.||30 days||||days||Full Range|Median
1245367|NCT00543296|Secondary|Number of Eyes With Increased Intraocular Pressure||52 weeks||||eyes|Participants||Number
1245368|NCT00543296|Secondary|Number of Participant's Eye Requiring Adjunctive Therapy|Adjunctive Therapy needed to control inflammation in the implanted eye|5 years|There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy|||participant's eyes|Participants||Number
1245369|NCT00543296|Secondary|Percentage of Eyes With Improvement in Visual Acuity|Visual acuity was improved by two or more lines from baseline.|baseline to 52 weeks|There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy|||percentage of eyes improved|Participants||Number
1245370|NCT00543296|Primary|Number of Eyes With Inflammation Recurrence|Number of eyes with inflammation recurrence|5 years||||eye with inflammation|Participants||Number
1245580|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245375|NCT00543140|Primary|Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.|"A reoperation was identified by satisfying all of the following criteria:~Is an SAE or is the action taken as the result of an SAE;~Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device;~Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and~Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device."|5 years|Consists of subjects who had a device implanted under protocol CI-07-0006 and subjects implanted under protocol CI-02-0006 and subsequently enrolled under protocol CI-06-0001.|||percentage of subjects||95% Confidence Interval|Number
1245376|NCT00543101|Secondary|Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)|Participants in the experimental arm completed treatment satisfaction questionnaires at 24 weeks, and the control arm at 48 weeks (24 weeks after mid-study crossover to boosted darunavir). The questionnaires used numeric satisfaction scales (+3 much more satisfied now to -3 much less satisfied now). We reported the median and ranges for each question for each study arm.|24 weeks||||Units on a Scale (+3 to -3)||Full Range|Median
1245377|NCT00543101|Secondary|Lipid Fraction Results, Mean of the Change From Baseline to Week 24.|We collected fasting total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides from all participants in both arms of the study. We calculated the differences between the values at week 24 and baseline for the participants in both arms. We reported the mean of the change from baseline to week 24.|baseline and 24 weeks||||mg/dL|||Number
1245378|NCT00543101|Secondary|Economic Impact of a Substitution of Dual Boosted PIs With DRV/r|To assess the economic impact of DRV/r substitution for dual boosted PIs, we compared the average wholesale acquisition costs for the drugs in US Dollars ($) per month. The wholesale acquisition cost in US dollars ($) for each ART regimen was determined and the difference between the cost for the experimental and control groups was calculated and reported as US dollar savings per month.|48 weeks||||US dollars savings per month|||Number
1245379|NCT00543101|Primary|The Percentage of Participants With Successful Virologic Suppression|Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as < 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.|24 weeks||||Percentage of Participants|||Number
1245380|NCT00542997|Other Pre-specified|Area Under the Concentration-Time Curve (AUCτ) of Total Serum IgG|AUCτ = Area under the concentration-time curve during regular dosing interval;|Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population. 7 subjects were missing data for AUCτ.|||day x g/L||Standard Deviation|Mean
1245381|NCT00542997|Other Pre-specified|Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG|AUC_last = Area under the concentration-time curve until last measured concentration.|Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.|||day x g/L||Standard Deviation|Mean
1245382|NCT00542997|Other Pre-specified|Timepoint of Maximum Concentration (Tmax) of Total Serum IgG||Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.|||day||Full Range|Median
1245383|NCT00542997|Other Pre-specified|Maximum Concentration (Cmax) of Total Serum IgG||Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.|||g/L||Standard Deviation|Mean
1245384|NCT00542997|Secondary|Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment|The annual rate was calculated based on the total number of days of antibiotic use in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|"ITT population analysis.~The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit)."|||days/subject/year|Participants||Number
1245385|NCT00542997|Secondary|Annual Rate of the Number of Days of Hospitalization Due to Infections|The annual rate was calculated based on the total number of days of hospitalization due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|"ITT population analysis.~The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit)."|||days/subject/year|Participants||Number
1245386|NCT00542997|Secondary|Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annual rate was calculated based on the total number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).|||days/subject/year|Participants||Number
1245387|NCT00542997|Secondary|Annual Rate of Infection Episodes|The annual rate of episodes was calculated based on the total number of any infection type and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).|||episodes/subject/year|Participants|95% Confidence Interval|Number
1245388|NCT00542997|Secondary|Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)|"Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.~The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the PPE population and adjusted to 365 days."|Efficacy period: week 12 to week 40 after study start or to the completion visit|Per Protocol Efficacy (PPE) population analysis. The PPE population included all subjects who completed the 28-week efficacy period according to protocol.|||SBIs/subject/year|Participants||Number
1245389|NCT00542997|Secondary|Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)|"Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.~The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days."|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).|||SBIs/subject/year|Participants||Number
1245390|NCT00542997|Primary|Total Serum IgG Trough Levels|Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject’s median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.|Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12). For 2 subjects in the ITT population, the pre-study treatment IgG trough levels were not available.|||g/L||Standard Deviation|Mean
1245391|NCT00542971|Secondary|Number of Participants With Complete Response|Complete response was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L platelets in the peripheral blood (PB).|Baseline to 2 years or disease progression.||||Participants|||Number
1245392|NCT00542971|Primary|Maximum Tolerated Dose (MTD)|MTD is dose level where grade 3-4 sorafenib-attributable toxicity in <2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0.|Twice a week for first two 28 day cycles|10 participants were treated with escalating doses of sorafenib with chemotherapy to establish the feasibility of the combination.|||milligrams/twice a day (BID)|||Number
1245393|NCT00542880|Secondary|The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Deviation|Mean
1245394|NCT00542880|Secondary|Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Deviation|Mean
1245395|NCT00542880|Secondary|Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||units on a scale||Standard Deviation|Mean
1245396|NCT00542880|Secondary|Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic|The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.|Baseline (run-in, and washout) and day 1 of treatment period|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
1245397|NCT00542880|Secondary|Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic|The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.|Baseline (run-in, and washout) and day 1 of treatment period|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
1245398|NCT00542880|Secondary|Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
1245425|NCT00542789|Primary|Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period|The absence of gastric and/or duodenal ulcer throughout the treatment period|each visit up to 24 weeks|Two participants were excluded from these sets because they took no investigational drug or had major protocol deviation. As the result, the numbers of participants for gender baseline were 173 in Esomeprazole 20 mg and 168 in Placebo, respectively.|||Participants|||Number
1245399|NCT00542880|Secondary|Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
1245400|NCT00542880|Secondary|Change in PEF From Before Dose to 15 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minute||Standard Deviation|Mean
1245401|NCT00542880|Secondary|Change in PEF From Before Dose to 5 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minute||Standard Deviation|Mean
1245402|NCT00542880|Secondary|FEV1 Before Evening Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
1245403|NCT00542880|Secondary|FEV1 15 Minutes After Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
1245404|NCT00542880|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
1245405|NCT00542880|Secondary|PEF Before Evening Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minute||Standard Deviation|Mean
1245406|NCT00542880|Secondary|PEF 15 Minutes After Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minute||Standard Deviation|Mean
1245407|NCT00542880|Secondary|PEF Before Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minutes||Standard Deviation|Mean
1245408|NCT00542880|Primary|Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose|The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||liters/minute||Standard Deviation|Mean
1245409|NCT00542828|Secondary|Number of Participants With a Marrow Remission|This is a measure of bone marrow complete remission for participants who experience a remission. Bone marrow complete remission is defined as a bone marrow assessment of <=5% myeloblasts and decrease by >=50% over pretreatment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245410|NCT00542828|Secondary|Number of Participants With a Cytogenetic Response|This is a measure of cytogenic response for participants whose best response to therapy is a either a complete or partial cytogenetic response. A complete cytogenetic response is defined as the disappearance of the chromosomal abnormality without appearance of new ones. A partial cytogenetic response is defined as at least 50% reduction of the chromosomal abnormality.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245411|NCT00542828|Secondary|Number of Participants With Transformation to Acute Myeloid Leukemia|This is a measure of transformation to acute myeloid leukemia only for participants who have bone marrow assessments. Transformation to acute myeloid leukemia is defined as the earliest date a participant experiences bone marrow blasts of >=20% after the start of treatment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245581|NCT00541658|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population||Week 52|ITT Population.|||Percent||95% Confidence Interval|Least Squares Mean
1245412|NCT00542828|Secondary|Number of Participants With Progression-free Survival|This is a measure of a progression-free survival which is defined as the time from the participant’s first dose to the date of disease progression, lost to follow-up or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245413|NCT00542828|Secondary|Number of Participants With a Relapse Following Overall Remission|This is a measure of relapse following an overall remission only for participants who experienced either a complete or partial remission. Relapse following an overall remission is defined as a participant who meets any of the following criteria: a return to pretreatment bone marrow blast percentage; decrease of >=50% from maximum remission levels in neutrophils or platelets; reduction in hemoglobin concentration by >=1.5 g/dL from maximum remission levels; or transfusion dependence.|36 months|Secondary outcome measure was not formally analyzed or assessed due to early study termination and small sample size (i.e., no study participants reached the 36-month time point)||||||
1245414|NCT00542828|Secondary|Number of Participants With a Relapse Following HI|This is a measure of relapse following HI, which is defined as a participant who experiences at least one of the following: >=50% decrease from maximum response levels in granulocytes or platelets; >=1.5 g/dL reduction in hemoglobin; or transfusion dependence.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245415|NCT00542828|Secondary|Number of Participants With Duration of Transfusion Independence|This is a measure of the duration of transfusion independence only for those participants who achieved transfusion independence. Duration of transfusion independence is defined as the longest period of time during which a participant requires no transfusions.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245416|NCT00542828|Secondary|Number of Participants Who Achieved Transfusion Independence|This is a measure of transfusion independence, which is defined as a participant with no transfusions for a period of 8 consecutive calendar weeks after first dose. Transfusion independence was to be calculated only for those participants who had documented transfusions during the 8 weeks prior to enrollment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245417|NCT00542828|Secondary|Duration of Disease Remission|This is a measure of the duration of overall disease remission only for those participants who achieved an overall remission. Duration of overall remission is defined as the time from first documentation of overall remission to the date of first documentation of disease relapse or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245418|NCT00542828|Secondary|Number of Participants Who Achieved Disease Remission|Disease remission is defined as a participant whose best response to therapy was a complete remission or partial remission. A complete remission is defined as: bone marrow <=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted; and peripheral blood hemoglobin >=11 g/dL, platelets >=100 x 10^9/L, neutrophils >=1.0 x 10^9/L, and blasts 0%. Partial remission is defined as: all complete remission criteria if abnormal before treatment, except bone marrow blasts decreased by >=50% over pretreatment, but still >5%; and cellularity and morphology not relevant.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245419|NCT00542828|Secondary|Number of Participants With Duration of HI|This is a measure of the duration of HI for those participants who achieved HI. Duration of HI is defined as the time from confirmation of HI response to the date of first documentation of HI relapse or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
1245420|NCT00542828|Primary|Number of Participants Who Achieved Hematologic Improvement (HI)|This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a >=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been <11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of >=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria.|12 months|Number of participants analyzed includes those who received treatment with Thymoglobulin and completed follow-up efficacy assessments. However, no formal efficacy analysis was conducted due to the small sample size and early study termination.|||participants|||Number
1245421|NCT00542815|Secondary|The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer|Percent Change from Baseline to Week 52 (LOCF)|52 weeks (Baseline-52 weeks)|ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.|||percentage change of LDL-cholesterol||Standard Deviation|Mean
1245422|NCT00542815|Primary|The Change in Serum Phosphorus for MCI-196 and Sevelamer|Change from Baseline to Week 52 (LOCF)|52 weeks (Baseline-52 weeks)|ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.|||mg / dL||Standard Deviation|Mean
1245423|NCT00542789|Secondary|Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment|The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment|up to 12 weeks||||Participants|||Number
1245424|NCT00542789|Secondary|Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment|The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment|up to 4 weeks||||Participants|||Number
1245427|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Very Happy Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and Week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||percentage of subjects|||Number
1245428|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Happy Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||percentage of subjects|||Number
1245429|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Sad Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and Week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||percentage of subjects|||Number
1245430|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L|Number of “symptoms only” hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||episodes|||Number
1245431|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L|Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||episodes|||Number
1245432|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - All Episodes|Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator’s judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||episodes|||Number
1245433|NCT00542620|Secondary|Body Mass Index (BMI) Z Score|Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||Z-score||Standard Deviation|Mean
1245434|NCT00542620|Secondary|Weight Z Score|Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||Z-score||Standard Deviation|Mean
1245435|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||hours||Standard Deviation|Median
1245436|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol.h/L||Standard Deviation|Median
1245437|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol.h/L||Standard Deviation|Median
1245438|NCT00542620|Secondary|Pharmacokinetics: Tmax of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||hours||Standard Deviation|Median
1245439|NCT00542620|Secondary|Pharmacokinetics: Cmax of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol/L||Standard Deviation|Median
1245440|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects|||hours||Standard Deviation|Median
1245441|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects|||pmol.h/L||Standard Deviation|Median
1245442|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol.h/L||Standard Deviation|Median
1245443|NCT00542620|Secondary|Pharmacokinetics: Tmax of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||hours||Standard Deviation|Median
1245444|NCT00542620|Secondary|Pharmacokinetics: Cmax of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol/L||Standard Deviation|Median
1245445|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects|||hours||Standard Deviation|Median
1245446|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.|||pmol.h/L||Standard Deviation|Median
1245447|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol.h/L||Standard Deviation|Median
1245448|NCT00542620|Secondary|Pharmacokinetics: Tmax of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||hours||Standard Deviation|Median
1245449|NCT00542620|Secondary|Pharmacokinetics: Cmax of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol/L||Standard Deviation|Median
1245450|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (After Dinner)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.|||mg/dL||Standard Deviation|Mean
1245451|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (Before Dinner)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||mg/dL||Standard Deviation|Mean
1245452|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (After Breakfast)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||mg/dL||Standard Deviation|Mean
1245453|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (Before Breakfast)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||mg/dL||Standard Deviation|Mean
1245454|NCT00542620|Secondary|Fructosamine||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||mmol/L||Standard Deviation|Mean
1245455|NCT00542620|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the ITT (Intention-to-Treat) set|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||percentage of total haemoglobin||Standard Deviation|Mean
1245582|NCT00541658|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population||Week 26|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245456|NCT00542620|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the Per Protocol (PP) set|Week 0 and Week 8|Per Protocol (PP) analysis set consists of all the ITT (Intention-to-Treat) subjects who did not present any significant protocol deviations that could potentially affect the efficacy results. One subject was excluded from PP as subject received separate injections despite being randomised to receive mixed injections.|||percentage of total haemoglobin||Standard Deviation|Mean
1245457|NCT00542542|Primary|Proportion of Participants With No Pain Immediately After Surgery|Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 – 24 hours post-operatively).|Starting immediately after surgery, every 2 hours till the 6th hour following surgery|Analysis was not possible from data collected due to reporting inconsistencies.||||||
1245458|NCT00542490|Secondary|Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy||2 years||||Participants|||Count of Participants
1245459|NCT00542490|Primary|Number of Patients With Progression-free Survival at 2 Years||2 years|19 of the 23 patients completed VCB and 3 cycles of chemotherapy|||Participants|||Count of Participants
1245460|NCT00542425|Secondary|Change in Bone Mineral Density, Total Spine.|Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.|12 months|The extension population included any patient who continued in the extended 24 weeks of treatment; N=55. 49 of the 55 extension patients had data available for analysis at Week 48.|||Percent change from baseline||Standard Deviation|Mean
1245461|NCT00542425|Secondary|Change in Bone Mineral Density, Total Hip.|Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.|||Percent change from baseline||Standard Deviation|Mean
1245462|NCT00542425|Secondary|Change in Bone Mineral Density, Femoral Neck.|Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.|||Percent change from baseline||Standard Deviation|Mean
1245463|NCT00542425|Primary|Change in Bone Mineral Density, Total Spine.|Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 187 of the 221 ITT patients had data available for analysis at Week 24.|||Percent change from baseline||Standard Deviation|Mean
1245464|NCT00542425|Primary|Change in Marker of Bone Metabolism, PINP|PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 193 of the 221 ITT patients had data available for analysis at Week 24.|||Percent change from baseline||Standard Deviation|Mean
1245465|NCT00542386|Secondary|The Incidence of Adverse Events||12 weeks|||||||
1245466|NCT00542386|Secondary|The Change in Ca x P Ion Product||12 weeks|||||||
1245467|NCT00542386|Secondary|The Change in Ca||12 weeks|||||||
1245468|NCT00542386|Secondary|The Change in PTH||12 weeks|||||||
1245469|NCT00542386|Secondary|The Change in Triglycerides||12 weeks|||||||
1245470|NCT00542386|Secondary|The Change in HDL-cholesterol||12 weeks|||||||
1245471|NCT00542386|Secondary|The Change in Total-cholesterol||12 weeks|||||||
1245472|NCT00542386|Primary|The Change in LDL-cholesterol|The percentage change from baseline to week 12|12 weeks|ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start of study medication.|||Percent change||Standard Deviation|Mean
1245473|NCT00542386|Primary|The Change in Serum Phosphorus|The change from baseline to week 12|12 weeks|ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start|||mg/dL||Standard Deviation|Mean
1245474|NCT00542321|Secondary|Turning-related Events|Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group|Participants were followed for the duration of time on protocol, an average of 3.5 days.|All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died after enrollment but before protocol could be initiated)|||Events||Standard Deviation|Mean
1245475|NCT00542321|Secondary|ICU All-cause Mortality.|Death from any reason between admission and discharge from study ICU|Participants were followed for the duration of ICU stay, an average of 10 days.|All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died before start of study protocol)|||participants|||Number
1245476|NCT00542321|Secondary|ICU Length of Stay.|Time in days from study ICU admission to study ICU discharge or death|Participants were followed for the duration of ICU stay, an average of 10 days.|All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 patient enrolled but died before started on protocol)|||Days||Inter-Quartile Range|Median
1245477|NCT00542321|Secondary|Mechanical Ventilation Duration.|Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation|Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.|All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 death before study protocol initiated)|||Days||Standard Deviation|Mean
1245478|NCT00542321|Primary|Incidence of Pulmonary Complications.|Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups.|Participants were followed for the duration of ICU stay, an average of 10 days.|Intention to treat; all 8 patients enrolled in kinetic therapy bed turn and 7 of 8 patients enrolled in manual turn (1 died before protocol initiated)|||participants|||Number
1245479|NCT00542308|Secondary|Tumour Response|Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0)J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|During treatment and two weeks after end of treatment, assessed up to 21 months.|All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.|||participants|||Number
1245480|NCT00542308|Primary|Overall Survival|Overall survival was defined as time from start of treatment until date of death of any cause.|From randomization until death, assessed up to 21 months|All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.|||months||95% Confidence Interval|Median
1245481|NCT00542269|Secondary|Percentage of Patients Who Developed Diabetes at End of Study|A patient had diabetes if fasting plasma glucose > 7 mmol/L.|Week 12|Intent-to-treat (ITT) population: All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the primary efficacy variable.|||Percentage of patients|||Number
1245482|NCT00542269|Secondary|Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine)||Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmol/mol||Standard Error|Least Squares Mean
1245483|NCT00542269|Secondary|Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine||Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmol/mol||Standard Error|Least Squares Mean
1245484|NCT00542269|Secondary|Change in HOMA-β From Baseline to End of Study|Homeostasis model assessment-β (HOMA-β) was defined as fasting insulin (μU/mL) x 20 / (fasting glucose (mmol/L) - 3.5).|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmol/L||Standard Deviation|Mean
1245485|NCT00542269|Secondary|Change in HOMA-IR From Baseline to End of Study|Homeostasis model assessment-insulin resistance (HOMA-IR) was defined as (fasting insulin [μU/mL] x fasting glucose [mmol/L]) / 22.5.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmol/L||Standard Deviation|Mean
1245486|NCT00542269|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure at End of Study|Normalized was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||Percentage of patients|||Number
1245487|NCT00542269|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmHg||Standard Error|Least Squares Mean
1245488|NCT00542269|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmHg||Standard Error|Least Squares Mean
1245489|NCT00542269|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmHg||Standard Error|Least Squares Mean
1245490|NCT00542269|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine)|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12||||mmHg||Standard Error|Least Squares Mean
1245491|NCT00542178|Secondary|Development or Progression of Macular Edema||Measured at Year 4||||Participants|||Count of Participants
1245492|NCT00542178|Secondary|Cataract Extraction||Measured at Year 4|Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information regarding whether or not they had a cataract extraction.|||Participants|||Count of Participants
1245494|NCT00542178|Primary|Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy|Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.|Measured at Year 4|The ACCORD Eye study recruited 3472 eligible participants. Of these, 2856 participants had both baseline and year 4 follow-up data available for analyses.|||participants|||Number
1245495|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245496|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245497|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245498|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245499|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245500|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245501|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245502|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245503|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245504|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245505|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245531|NCT00541931|Primary|Change in Fine Wrinkling|Assessed by 4 dermatologists blinded to chronological age and smoking status, on a 10-point Likert scale (min 1/max 10); lower scores indicate less wrinkling and higher scores indicate more wrinkling. Values are the average of scores given by the four raters. Change was calculated as the baseline value minus the week 12 value.|Baseline; week 12|Participants completing the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
1245506|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245507|NCT00541970|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.|Within 30 days (Day 0-29) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245508|NCT00541970|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245509|NCT00541970|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.|From Month 0 to Month 48.|The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1245510|NCT00541970|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)|Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.|At Month 60 of the safety follow-up phase|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1245511|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).|At Month 60 of the safety follow-up phase|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1245512|NCT00541970|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)|Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.|At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1245513|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245514|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, on subjects with available results.|||Participants|||Count of Participants
1245515|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245516|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245517|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245518|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245519|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245520|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245521|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245532|NCT00541931|Primary|Fold Change in Long Chain Fatty Acids|Peripheral blood long chain fatty acids were measured. Fold change of 1 = no difference; if metabolites decrease at week 12 from baseline, the fold change will be <1.|Baseline; Week 12|Participants completing the protocol were included in the analysis.|||Fold Change in long chain fatty acids||Full Range|Mean
1245522|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245523|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245524|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 7, 1 month after the last dose of vaccine or placebo.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1245525|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects eligible for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1245526|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.|At Month 7, 1 month after the last dose of vaccine or placebo.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1245527|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.|At Month 3, 1 month after the second dose of vaccine or placebo|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1245528|NCT00541970|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.|Within 7 days (Day 0-6) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245529|NCT00541970|Primary|Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).|Within 7 days (Day 0-6) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
1245530|NCT00541970|Primary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1245534|NCT00541866|Secondary|Overall Survival|Overall survival is censored at the earlier of the cutoff date for analysis and the last date known to be alive for patients not known to have died.|Time between the date of first study treatment and the date of death due to any cause for upto 2 years after the end of study visit|All treated analysis set|||months||95% Confidence Interval|Median
1245535|NCT00541866|Secondary|Leukemia-free Survival (LFS)|Leukemia-free survival is censored at the last known alive date without report of relapse.|From time of the start of CR or CRp to the earliest date of relapse, commencement of reinduction therapy, or death, assessed monthly up to 2 years after the end of study visit.|All treated analysis set.|||months||95% Confidence Interval|Median
1245536|NCT00541866|Secondary|Remission Rates (CR+CRp)|"Complete remission (CR) plus CR with incomplete platelet recovery (CRp) per The IWG criteria for remission modified by Sunesis, assessed by investigator.~CR is defined as >1000 Neutrophils (ul), >100,000 Platelets (uL) and <5 BM Blasts (%); CRp is defined as >1000 Neutrophils (ul), <=100,000 Platelets (uL) and <5 BM Blasts (%); CRi is defined as >1000 Neutrophils (ul), <100,000 Platelets (uL) and <5 BM Blasts (%); Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (CR with morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse."|Monthly after the end of treatment for the first year, then every 2 months thereafter for upto 2 years|All treated set which includes all enrolled patients who received any IMP.|||Participants|||Count of Participants
1245537|NCT00541866|Primary|Incidence of Dose-Limiting Toxicity (DLT) to Determine Maximum Tolerated Dose in Schedule A and Schedule B of Dose Escalation Phase (Group 1 and Group 2)|Patients were treated in cohorts with escalating doses of vosaroxin administered in combination with cytarabine in Schedule A, and with vosaroxin in escalating doses in Schedule B. For both Schedules, the highest dose at which fewer than 2 of 6 (<0.33) patients experienced a dose-limiting toxicity (DLT) during induction became the MTD and the recommended future dose.|From start of treatment (Day 1) through Induction Day 29 or the start of reinduction, whichever occurred first.|Patients experiencing a dose-limiting toxicity (DLT) during induction when treated with escalating doses of vosaroxin administered in combination with cytarabine on Days 1 and 4 in Schedule A, and with vosaroxin in escalating doses administered on Days 1 and 4 in Schedule B.|||Participants|||Count of Participants
1245538|NCT00541775|Secondary|2-hour Post-meal Glucose (PMG) at Week 18|The change from baseline is the Week 18 PMG minus the Week 0 PMG.|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1245539|NCT00541775|Secondary|Fasting Plasma Glucose (FPG) at Week 18|The change from baseline is the Week 18 FPG minus the Week 0 FPG.|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1245540|NCT00541775|Primary|Hemoglobin A1C (A1C) at Week 18|"A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.~The study hypothesis comparison was between sitagliptin versus placebo."|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
1245541|NCT00541671|Primary|Number of Patients Who Became Nauseated After IV Opiate Administration.||4 hours post opiate administration||||participants|||Number
1245542|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Participants|||Number
1245543|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 104||Week 104|ITT Population|||Participants|||Number
1245544|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Participants|||Number
1245545|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 52||Week 52|ITT Population|||Participants|||Number
1245546|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Participants|||Number
1245547|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population||Week 104|ITT Population.|||Participants|||Number
1245548|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Participants|||Number
1245549|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 52||Week 52|ITT Population|||Participants|||Number
1245550|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245551|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population||Week 104|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245552|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245553|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population||Week 52|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245554|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population||Week 26|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245583|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percentage of Participants|||Number
1245584|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52|ITT Population|||Percentage of Participants|||Number
1245585|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percentage of Participants|||Number
1245586|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52|ITT Population.|||Percentage of Participants|||Number
1245587|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245588|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population||Week 104|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1245589|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population||Week 52|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1245590|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population||Week 26|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1245591|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|35 mg group combined delayed-relase following breakfast (DRFB) group with delayed-relase before breakfast (DRBB) group and compared with 5 mg immediate-release before breakfast (IRBB) group. ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245592|NCT00541658|Primary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population||52 weeks / Endpoint|Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
1245593|NCT00541593|Primary|Mortality|"Number of patients who died as a result of the surgery: Death (mortality).~Please note that pain was previously listed as an outcome measure, but this was edited out of this submission and was not tracked as an outcome measure."|One year|Patients who had the diagnosis, qualified anatomically, and were interested in the research study (and who met inclusion criteria but not exclusion criteria) were enrolled.|||participants|||Number
1245594|NCT00541450|Secondary|Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for FPG.|||mg/dL||95% Confidence Interval|Least Squares Mean
1245595|NCT00541450|Secondary|Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks|The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.|Baseline and 40 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and (2) had a baseline measurement and at least one on-treatment measurement for FPG.|||mg/dL||95% Confidence Interval|Least Squares Mean
1245596|NCT00541450|Secondary|Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for PMG.|||mg/dL||95% Confidence Interval|Least Squares Mean
1245597|NCT00541450|Primary|Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for A1C.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1245598|NCT00541450|Secondary|Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks|The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.|Baseline and 40 weeks|"All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and~(2) had a baseline measurement and at least one on-treatment measurement for PMG."|||mg/dL||95% Confidence Interval|Least Squares Mean
1245871|NCT00538980|Secondary|Changes in Marrow Cellularity, Reticulin and Fibrous Content|To determine changes in marrow cellularity, reticulin and fibrous content. Analysis was not completed because the study was terminated early due to lack of efficacy.|Bone marrow analysis will be performed at baseline and month 6.|||||||
1245599|NCT00541450|Primary|Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks|The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.|Baseline to 40 weeks|"All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and~(2) had a baseline measurement and at least one on-treatment measurement for A1C."|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1245600|NCT00541346|Secondary|Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit|This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245601|NCT00541346|Secondary|Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit|The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245602|NCT00541346|Secondary|Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit|The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245603|NCT00541346|Secondary|Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit|The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245604|NCT00541346|Secondary|Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit|The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245605|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245606|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245618|NCT00541229|Primary|24-hour Weighted Mean Glucose (WMG)|The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.|Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.|The per-protocol (PP) population consisted of all patients randomized who had a measurement at Day 7 in Treatment Period I and did not have any major protocol violations. Missing data were not imputed.|||mg/dL||95% Confidence Interval|Least Squares Mean
1245607|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245608|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245609|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245610|NCT00541346|Primary|Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit|This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
1245611|NCT00541307|Secondary|Device-related Major Adverse Events at 12 Months|If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|12 months||||event|||Number
1245612|NCT00541307|Secondary|Secondary Patency|Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency.|12 months||||percentage of subjects||95% Confidence Interval|Number
1245613|NCT00541307|Secondary|Primary Assisted Patency|Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency.|12 months||||percentage of subjects||95% Confidence Interval|Number
1245614|NCT00541307|Secondary|Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days|If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|30 days||||participants|||Number
1245615|NCT00541307|Primary|Primary Patency at 12 Months|Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area).|12 months||||percentage of subjects||95% Confidence Interval|Number
1245616|NCT00541242|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18|Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Week 18|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1245617|NCT00541242|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12|Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Week 12|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1245907|NCT00538785|Primary|Number of Subjects Reporting Laboratory Adverse Events||Days 0-150|Safety population|||participants|||Number
1245619|NCT00541190|Secondary|Mucociliary Clearance Rate|"Mucociliary clearance rate represents the rate at which the lungs clear an inhaled particulate. Here it specifically represents the percentage of inhaled Technetium 99m sulfur colloid cleared from the lungs over a 60 minute period. This is reported based on whole lung areas to allow comparisons with previous studies."|single measurement|No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.|||percentage lung clearance per hour||Standard Deviation|Mean
1245620|NCT00541190|Primary|Absorptive Clearance Rate|The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways.|single measurement|No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.|||percentage of DTPA absoprtion per hour||Standard Deviation|Mean
1245621|NCT00541099|Secondary|Toxicity|Toxicity: using the highest grade of each toxicity experienced by each patient.|1st and 2nd week of each 21 day cycle||||Adverse event|||Number
1245622|NCT00541099|Secondary|Response Rate||Every 8 weeks|||||||
1245623|NCT00541099|Secondary|Overall Survival|Overall survival using Kaplan-Meier method.|4 weeks after removal from study or until death||||months||95% Confidence Interval|Median
1245624|NCT00541099|Secondary|Progression-free Survival||6 months when treated with combination of Avastin and weekly docetaxel|||||||
1245625|NCT00541099|Primary|Survival||6 months when treated with combination of Avastin and weekly docetaxel||||percentage of participants surviving||90% Confidence Interval|Number
1245626|NCT00541034|Primary|Overall Objective Response|The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.|2 years||||Participants|||Count of Participants
1245627|NCT00540969|Secondary|Average Difference in Pre- and Post-treatment Physical (PCS-8) and Mental (MCS-8) Quality of Life at Week 6 as Measured by the 2 Subscales of the Short Form (SF)-8||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
1245628|NCT00540969|Secondary|Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
1245629|NCT00540969|Primary|Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
1245630|NCT00540722|Other Pre-specified|Explore Clinical Outcome (Overall Survival) With Changes of Potential Serum Biomarkers, Baseline Tumor Protein Expression and Gene Methylation Status|Archived tumor tissue and 1 serum sample pre first dose and 1 sample anytime during week 2 of cycle 1|1 month|no data to report. Not enough archived tumor tissue and survival outcome did not warrant an analysis of the Pharmacokinetics (PK)||||||
1245631|NCT00540722|Secondary|Progression-free Survival Rate, Defined as Patient Who is Alive and Disease Progression Free at the Time of 26-week (6 Months) From First Day of the Treatment|The probability of 6-month progression-free survival will be estimated using binomial distribution.|6 months||||months||95% Confidence Interval|Median
1245632|NCT00540722|Secondary|Tumor Response Rate|"Complete response Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks Partial response Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease Clinical status and MRI does not qualify for complete response, partial response or progression"|3 years|5 patients were not evaluable for response|||Participants|||Count of Participants
1245633|NCT00540722|Secondary|Percent of Patients With Grade 3 and 4 Adverse Events Related to Treatment|The proportion of patients with serious or life threatening (grade 3 and 4) toxicities will be estimated using NCI CTCAE|3 years||||percentage of participants|||Number
1245634|NCT00540722|Primary|Overall Survival|The overall failure rate will be estimated along with 95% confidence intervals. A median time of survival will be estimated using standard methods.|4.5 years||||months||95% Confidence Interval|Median
1245635|NCT00540644|Secondary|Quality of Life Using the FACT-G Data|"Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.~Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome"|baseline and after last cycle (up to 6 cycles)|All patients enrolled and received treatment with a baseline and post-baseline measurement.|||scores on a scale||Standard Deviation|Mean
1245636|NCT00540644|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.|Beginning of treatment up to 5 years|All patients enrolled and received treatment.|||participants|||Number
1245759|NCT00540007|Secondary|Time to Progression (TTP).|-Time to progression (TTP) is defined as the time from study entry until documented lymphoma progression or death as a result of lymphoma.|Through 3.5 years from study entry or until disease progression|(2) participants were not evaluable in Cohort 2 because 2 patients did not have progression, death dates, or last follow-up dates so time to progression cannot be calculated.|||months||Inter-Quartile Range|Median
1245637|NCT00540644|Primary|Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria|Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.|After 6 cycles|All patients receiving at least one dose of study drug and having at least one post-baseline visit|||percentage of participants||95% Confidence Interval|Number
1245638|NCT00540592|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Between Day 21 and Day 179 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1245639|NCT00540592|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Between Day 0 and Day 20 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1245640|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.|Between Day 21 and Day 179 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1245641|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.|Between Day 0 and Day 20 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1245642|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1245643|NCT00540592|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.|||Days||Full Range|Median
1245644|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Subjects|||Number
1245645|NCT00540592|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.|||Days||Full Range|Median
1245646|NCT00540592|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. > 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Subjects|||Number
1245658|NCT00540592|Secondary|HI Antibody Titers at Day 0 and Day 21|Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
1245647|NCT00540592|Secondary|The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180|The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||cells per million CD8 T-cells||Standard Deviation|Geometric Mean
1245648|NCT00540592|Secondary|The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21|The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.|||cells per million CD8 T-cells||Standard Deviation|Geometric Mean
1245649|NCT00540592|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180|The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 180.|||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
1245650|NCT00540592|Secondary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21|The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.|||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
1245651|NCT00540592|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.|||Subjects|||Number
1245652|NCT00540592|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Subjects|||Number
1245653|NCT00540592|Secondary|HI Antibody Seroconversion Factors at Day 180|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.|||fold increase||95% Confidence Interval|Geometric Mean
1245654|NCT00540592|Secondary|HI Antibody Seroconversion Factors at Day 21|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||fold increase||95% Confidence Interval|Geometric Mean
1245655|NCT00540592|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.|||Subjects|||Number
1245656|NCT00540592|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Subjects|||Number
1245657|NCT00540592|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.|||titer||95% Confidence Interval|Geometric Mean
1245678|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48||Week 48|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245659|NCT00540592|Primary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
1245660|NCT00540579|Primary|The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0|The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE)|24 Months|All patients treated with pomalidomide and gemcitabine were assessed for Grade 3/4 toxicities|||percentage of patients||95% Confidence Interval|Number
1245661|NCT00540579|Primary|Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects|"Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows:~Inability to Complete cycle 1 of therapy due to drug-related toxicity.~> Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care~Febrile neutropenia (absolute neutrophil count [ANC] <1,000/μL and fever >101° F (38.5° C))~Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT)~Platelet count < 25,000/μL~Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity."|6 months|Two patients withdrew consent and were unevaluable for DLT. One patient suffered subdural hematoma (non-treatment related) and was unevaluable for DLT.|||milligrams|||Number
1245662|NCT00540514|Other Pre-specified|Time to Improvement of ≥ Grade 3 Treatment Related Peripheral Neuropathy|"Peripheral neuropathy was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.~Improvement in peripheral neuropathy was evaluated as:~Time to improvement of grade 3 or higher peripheral neuropathy by at least one grade;~Time to improvement of grade 3 or higher peripheral neuropathy to grade 1.~Time to improvement was defined as the time from the first occurrence of grade 3 or higher treatment related neuropathy to improvement, as defined. Participants not experiencing improvement were censored at the last time the participant was evaluated for adverse events."|38 months|Treated population with ≥ grade 3 treatment-related peripheral neuropathy.|||days||95% Confidence Interval|Median
1245663|NCT00540514|Other Pre-specified|Maximal Degree of Thrombocytopenia Based on Clinical Laboratory Values of Platelet Count|The maximal degree of thrombocytopenia (and myelosuppression) was assessed by the overall nadir of platelet count based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.|||× 10^9/L||Standard Deviation|Mean
1245664|NCT00540514|Other Pre-specified|Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count|The maximal degree of neutropenia (and myelosuppression) was assessed by the overall nadir of absolute neutrophil count (ANC) based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.|||× 10^9/L||Standard Deviation|Mean
1245665|NCT00540514|Other Pre-specified|Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin|The maximal degree of anemia (and myelosuppression) was assessed by the overall nadir of hemoglobin levels based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.|||g/L||Standard Deviation|Mean
1245666|NCT00540514|Other Pre-specified|Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology|"Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.~A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.~Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesions).~Histology was determined at the time of primary diagnosis."|Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.|The intent-to-treat population. N indicates the number of participants in each histology category for each treatment arm respectively.|||percentage of participants|||Number
1245667|NCT00540514|Secondary|SPARC Status and Correlation With Overall Survival|"The expression and cellular distribution of Secreted Protein Acidic and Rich in cysteine (SPARC) in biopsies of lung tumor was examined by immunohistochemistry using a 2 antibody system by an approved central laboratory and analyzed by 2 pathologists. The following tissue components were scored: tumor cells, fibroblasts, inflammatory cells, acellular stroma/matrix, and blood vessels.~To classify participants into high-SPARC and low-SPARC groups, an average z-score was calculated across variables and classified high-SPARC (average z-scores ≥0) and low-SPARC (average z-scores <0) groups.~SPARC status was then correlated with overall survival (the time from the day of randomization to participant death due to any cause)."|Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months.|SPARC biomarker Population|||participants|||Number
1245668|NCT00540514|Secondary|Pharmacokinetic (PK) Parameters||Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion.|Patients randomized to receive albumin-bound paclitaxel/carboplatin treatment in Canada, Russia, Ukraine and United States had the option to participate in sparse PK sampling in this study. Only 15 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed.||||||
1245669|NCT00540514|Secondary|Number of Participants With Adverse Events (AEs)|A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Up to 38 months|Treated population|||participants|||Number
1245670|NCT00540514|Secondary|Duration of Response in Responding Patients|Duration of response was assessed by progression free survival for participants who achieved a confirmed complete response or partial response based on blinded radiological assessment.|Assessed every 6 weeks, up to 38 months|Intent-to-treat patients with an objective response.|||months||95% Confidence Interval|Median
1245671|NCT00540514|Secondary|Percentage of Participants With Controlled Disease|Controlled disease was defined as the percentage of participants with stable disease for ≥ 16 weeks or confirmed complete or partial overall response, based on blinded radiological assessment. Stable disease was defined as neither sufficient shrinkage of target lesions to qualify for Partial Response, nor sufficient increase to qualify for Progressive Disease, or the persistence of one or more non-target lesions not qualifying for Complete Response or Progressive Disease.|Assessed every 6 weeks, up to 22 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1245672|NCT00540514|Secondary|Overall Participant Survival|Overall survival was defined as the time from the day of randomization to participant death (due to any cause), as assessed by post study follow-up performed monthly for 6 months and every 3 months thereafter for 12 months. All participants who were lost to the follow-up prior to the end of the trial or who completed the 18 month follow up phase were censored at last known time the participant was alive.|Up to 38 months|Intent-to-treat|||months||95% Confidence Interval|Median
1245673|NCT00540514|Secondary|Progression-free Survival by Blinded Radiology Assessment|"Progression free survival time was defined as the time from the day of randomization to the start of disease progression or death (any cause), whichever occurred first, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the SLD of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the presence of one or more new lesions, or the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesion(s).~Participants who did not have disease progression or had not died were censored at the last visit they were documented as progression free. If palliative radiotherapy or surgery at lesion sites occurred, the participant was censored at the last date without documented progression prior to radiotherapy or surgery. In follow-up, participants who began new therapy prior to progression were censored at the last documented date as progression-free."|Assessed every 6 weeks until progression or death, up to 38 months|Intent-to-treat|||months||95% Confidence Interval|Median
1245674|NCT00540514|Primary|Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment|"Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.~A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.~Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the “unequivocal progression” of existing non-target lesion(s) or appearance of one or more new lesions)."|Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.|The intent-to-treat population which includes all randomized patients regardless of whether the patient received any study drug or had any efficacy assessments collected.|||percentage of participants||95% Confidence Interval|Number
1245675|NCT00540449|Secondary|Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 96|"The ITT analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome measure."|||Participants|||Number
1245676|NCT00540449|Secondary|Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline, Week 48, and Week 96|The ITT analysis set was considered the primary efficacy analysis set.|||cells per microliter||Standard Deviation|Mean
1245677|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96||Week 96|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245679|NCT00540449|Secondary|Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).|Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per ml at the last on-treatment visit (post-Week 96).|Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit|Participants with at least 1 Post-Week 96 visit were included in the analysis.|||Participants|||Number
1245680|NCT00540449|Secondary|The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245681|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96||Week 96|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245682|NCT00540449|Secondary|The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48|The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/ml (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/ml in the Wk48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/ml and subjects who had a switch in background regimen that was not permitted by the protocol.|Week 48|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245683|NCT00540449|Primary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48|Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).|Week 48|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1245684|NCT00540436|Secondary|Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24|Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. BNP is a surrogate maker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||Nanograms/Liter (ng/L)||Standard Deviation|Mean
1245685|NCT00540436|Secondary|Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24|PVR is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||mmHg/L/min||Standard Deviation|Mean
1245686|NCT00540436|Secondary|Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24|CO is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||L/min||Standard Deviation|Mean
1245687|NCT00540436|Secondary|Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24|CI is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||L/min/m2||Standard Deviation|Mean
1245688|NCT00540436|Secondary|Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24|mPAP and mRAP are measures of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||mmHg||Standard Deviation|Mean
1245689|NCT00540436|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event|Time to clinical worsening is defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or study discontinuation due to change to other PAH treatment. Time to clinical worsening is measured as the number of participants who experienced these events during 24 weeks.|Week 24|Full Analysis Set: : all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product|||Participants|||Number
1245690|NCT00540436|Secondary|Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24|There are four grades for WHO FC (class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Imputation technique was last observation carried forward.|Weeks 12 and 24|Full Analysis Set|||Participants|||Number
1245719|NCT00540293|Secondary|Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.|Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS|Baseline, and 8 weeks|Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).|||pg/dL||95% Confidence Interval|Median
1245691|NCT00540436|Secondary|Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from baseline was calculated as the Week 12 and 24 values minus the baseline values. The BDI indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI scale was assessed by each participant. Imputation technique was last observation carried forward.|Baseline and Weeks 12 and 24|Full Analysis Set|||Points on a scale||Standard Deviation|Mean
1245692|NCT00540436|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal|Change from baseline was calculated as the Week 24/Withdrawal value minus the basline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes. Imputation technique was last observation carried forward.|Baseline and Week 24/Withdrawal|Full Analysis Set|||Meters||Standard Deviation|Median
1245693|NCT00540436|Primary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12|Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.|Baseline and Week 12|Full Analysis Set (FAS): all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product. Imputation technique was last observation carried forward.|||Meters||Standard Deviation|Mean
1245694|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Vz/F|VZ/F: VZ is the volume of distribution based on the terminal phase, and F is the fraction of dose absorbed.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||Liters||Standard Deviation|Mean
1245695|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, CL/F|CL/F: CL is an estimate of the total body clearance, and F is the fraction of dose absorbed.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||L/hr (Liters/hour)||Standard Deviation|Mean
1245696|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24|"AUC is area under a concentration vs. time curve.~AUC0-24 (Area under the plasma concentration-time curve between 0 to 24 hrs) is calculated using the following equation:~AUC0-24= AUClast + Clast × (1 - e-λz × [24-tlast])/λz. AUClast is AUC (area under a curve) computed to the last observation. Clast is concentration of last observation."|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||hr*ng/mL||Standard Deviation|Mean
1245697|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Lambda z|Lambda z is first order rate constant associated with the terminal portion of the plasma concentration curve.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||1/hour||Standard Deviation|Mean
1245698|NCT00540423|Secondary|Pharmacokinetics of SB-497115, t1/2|t1/2 is half life based on the terminal phase|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||Hours||Standard Deviation|Mean
1245699|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Tmax|tmax: Time when Cmax was achieved|Week 9 or 10|PK Population|||Hours||Full Range|Median
1245700|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Cmax|Cmax: Peak plasma concentration of SB-497115|Week 9 or 10|Pharmacokinetic (PK) Population: all participants with valid PK data following SB-497115-GR treatment|||ng/mL (nanograms/milliliter)||Standard Deviation|Mean
1245701|NCT00540423|Secondary|Mean Number of Days of Concomitant ITP Medication Use Per Month|Cumulative number of days for which a participant received ITP medication during the treatment/total treatment period (months). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set|||Days||Standard Deviation|Mean
1245702|NCT00540423|Secondary|Percentage of Participants Who Received Rescue Treatment for ITP|Rescue treatment for ITP is treatment applied to participants at high bleeding risk, such as those undergoing platelet transfusion or dose increase of steroids. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set|||Percentage of participants|||Number
1245703|NCT00540423|Secondary|Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline|ITP medications are drugs, such as steroids or immunoglobulin, to be used for ITP. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline through Week 26|Full Analysis Set. Four participants in the Full Analysis Set did not have concomitant ITP medication at Baseline.|||Percentage of participants|||Number
1245704|NCT00540423|Secondary|Percentage of Participants With Bleeding Episode Since the Last Visit|When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set|||Percentage of participants|||Number
1245720|NCT00540293|Secondary|Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment|Percent change from baseline in hs-CRP by risk group - FAS|4 and 8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||percentage||95% Confidence Interval|Median
1245760|NCT00540007|Secondary|Participant Response Rate in Relapsed or Refractory cHL.|-Definitions per 2007 Cheson Lymphoma Response Criteria|Through 3.5 years from study entry or until disease progression||||Participants|||Count of Participants
1245705|NCT00540423|Secondary|Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter|Total time is measured as the cumulative number of days over which platelet counts were maintained within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set|||Days||Standard Deviation|Mean
1245706|NCT00540423|Secondary|Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter|Maximum duration is measured as the longest period (days) for which a participant continuously maintained platelet counts within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set|||Days||Standard Deviation|Mean
1245707|NCT00540423|Secondary|Mean Change From Baseline in Platelet Counts at Each Visit|Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 and Weeks 10, 14, 18, 22, and 26 minus baseline value. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set|||10^9/Liter||Standard Deviation|Mean
1245708|NCT00540423|Secondary|Mean Platelet Counts of Participants at Each Visit|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set|||10^9/Liter||Standard Deviation|Mean
1245709|NCT00540423|Secondary|Percentage of Responders at Each Visit|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set|||Percentage of responders|||Number
1245710|NCT00540423|Secondary|Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set|||Participants|||Number
1245711|NCT00540423|Secondary|Percentage of Participants With Bleeding Episodes Since the Last Visit|When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s).|Days 1, 8, 15, 22, 29, 36, and 43|Full Analysis Set|||Percentage of participants|||Number
1245712|NCT00540423|Secondary|Mean Change From Baseline in Platelet Counts at Each Visit|Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 minus baseline value|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set|||10^9/Liter||Standard Deviation|Mean
1245713|NCT00540423|Secondary|Mean Platelet Count at Each Visit|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set|||10^9/Liter||Standard Deviation|Mean
1245714|NCT00540423|Secondary|Percentage of Responders at Each Visit|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).|Days 8, 15, 22, 29, 36, and 43|Full Analysis Set|||Percentage of responders|||Number
1245715|NCT00540423|Primary|Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Week 26|Full Analysis Set|||percentage of participants|||Number
1245716|NCT00540423|Secondary|Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter) at at least 4 out of 5 scheduled visits.|Weeks 2 through 6|Full Analysis Set|||Participants|||Number
1245717|NCT00540423|Primary|Number of Responders at Week 6|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).|Week 6|Full Analysis Set: all randomized participants, with the exception of (1) those who did not receive any dose of study medication and (2) those with no valid platelet count measurements on therapy|||Participants|||Number
1245718|NCT00540293|Secondary|Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.|Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS|8 weeks|Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).|||percent||95% Confidence Interval|Median
1245761|NCT00540007|Secondary|Cytostatic Overall Response Rate|"Cytostatic overall response rate = CR + PR + SD greater than or equal to 6 months~Definitions per 2007 Cheson Lymphoma Response Criteria"|From 6 months through 3.5 years after study entry||||Participants|||Count of Participants
1245721|NCT00540293|Primary|Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.|LDL-C Responders by visit and by risk group - full analysis set (FAS)|Week 8|N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward)|||Percentage of participants||95% Confidence Interval|Mean
1245722|NCT00540293|Secondary|Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment|Median baseline, and change from baseline in hs-CRP by risk group - FAS|4 and 8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||mg/dL||95% Confidence Interval|Median
1245723|NCT00540293|Secondary|Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.|LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)|8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||percentage of participants||95% Confidence Interval|Mean
1245724|NCT00540293|Secondary|Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.|LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)|8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||Participants|||Number
1245725|NCT00540293|Secondary|Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment|Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride|weeks 4 and 8|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||Percent||95% Confidence Interval|Mean
1245726|NCT00540293|Secondary|Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment|Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride|Weeks 4 and 8||||mg/dL (ratio for Scalar)||95% Confidence Interval|Mean
1245727|NCT00540293|Secondary|Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.|LDL-C Responders by visit and by risk group - FAS|Week 4||||Percent subjects achieved LDL-C target||95% Confidence Interval|Mean
1245728|NCT00540228|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 180|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1245729|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1245730|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).|MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination|From Day 0 to Day 180|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1245731|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1245732|NCT00540228|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.|During the 7-day (Days 0-6) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1245733|NCT00540228|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||cells||Standard Deviation|Mean
1245734|NCT00540228|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||cells||Standard Deviation|Mean
1245735|NCT00540228|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1245736|NCT00540228|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1245737|NCT00540228|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1245738|NCT00540228|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1245739|NCT00540228|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1245740|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)|Vcomp, defined as the volume of voided urine (measured in milliliters [mL]).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||milliliters||Standard Deviation|Mean
1245741|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)|Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||milliliters per second||Standard Deviation|Mean
1245742|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary|A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||average number per week||Standard Deviation|Mean
1245743|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary|A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||average number per week||Standard Deviation|Mean
1245744|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary|Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||average number per week||Standard Deviation|Mean
1245745|NCT00540124|Secondary|Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies|"Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)."|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||participants|||Number
1245746|NCT00540124|Secondary|Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies|"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)."|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||participants|||Number
1245747|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)|The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1245748|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore|IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1245749|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore|The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1245750|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore|The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1245751|NCT00540124|Secondary|Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|baseline, 4 and 8 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1245752|NCT00540124|Primary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|baseline, 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1245753|NCT00540046|Secondary|Expulsion|IUD was not removed by provider but fell out on its own.|6 months|The analysis here includes the 64/71 A/Immediate arm and 26/88 B/Delayed arm who received an IUD. In the A/Immediate arm, 5 women changed their mind post-randomization and in 2 cases, the provider chose not to place it. In the B/Delayed arm, reasons included not returning for follow-up visit, changing mind, and provider not wanting to place IUD.|||percentage of expulsions|||Number
1245754|NCT00540046|Primary|Use of IUD|Number of participants using Copper T380A IUD 6 months after surgery|6 months||||participants|||Number
1245755|NCT00540007|Secondary|Duration of Response|-Duration of response: defined as the interval from the date of response (CR or PR) is documented to the date of progression, taking as reference the smallest measurements recorded since the treatment started|Through 3.5 years from study entry or until disease progression|(2) participants were not evaluable in Cohort 2 because 2 patients did not have progression, death dates, or last follow-up dates so time to progression cannot be calculated.|||months||Inter-Quartile Range|Median
1245756|NCT00540007|Secondary|Event Free Survival (EFS).|-Event-free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).|Through 3.5 years from study entry or until disease progression|2 participants in Cohort 2 were not evaluable because these patients did not have a date of progression, treatment failure, death or last follow-up so RFS could not be calculated.|||months||95% Confidence Interval|Median
1245757|NCT00540007|Secondary|Relapse Free Survival (RFS)||Through 3.5 years from study entry or until disease progression|2 participants in Cohort 2 were not evaluable because these patients did not have a date of progression, treatment failure, death or last follow-up so RFS could not be calculated.|||months||95% Confidence Interval|Median
1245758|NCT00540007|Secondary|Overall Survival (OS)|Overall survival is defined as the time from entry onto the clinical trial until death as a result of any cause.|Through 3.5 years from study entry or until disease progression|1 participant was not evaluable in Cohort 1 and 5 participants were not evaluable in Cohort 2 because these participants did not have death dates or last follow-up dates so overall survival cannot be calculated.|||months||95% Confidence Interval|Median
1245762|NCT00540007|Secondary|Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.|"Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0~The higher the grade the worse the adverse event was considered"|30 days following the completion of treatment||||participants|||Number
1245763|NCT00540007|Primary|Objective Overall Response Rate (ORR) in Relapsed or Refractory cHL.|"Overall response rate = CR + PR~Definitions per 2007 Cheson Lymphoma Response Criteria"|Through 3.5 years from study entry or until disease progression||||percentage of participants||95% Confidence Interval|Number
1245764|NCT00539994|Other Pre-specified|Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12|All subjects were positive (pos.) for S. Aureus in the Pharyngeal region on days 12 or 33 (D12 and D33) and Negative (neg.) in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.|Days 7, 12, and 33.|Per Protocol Population: Persistant Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and those who were Positive for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.|||Percentage of participants|||Number
1245765|NCT00539994|Secondary|Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)|The number of participants who tested negative for MRSA on days 7, 12, and 33.|Days 7, 12, or 33.|Screening Eligibility Population: only participants who provided nasal cultures at Days 7, 12, and 33 were analyzed.|||participants|||Number
1245766|NCT00539994|Secondary|Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.|All participants were assessed for nasal and pharyngeal carriage at Screening Visits 1, 2, and 3. Participants were randomized into the study only if they had positive cultures at screening visit 1 and screening visit 2 and/or screening visit 3. Day 1 data were collected only for those participants who were randomized into the study.|Screening Visits 1 (Day -42 to Day -14), 2 (Day -11 to Day -4), and 3 (Day -11 to Day -4) and Day 1|Screening Population (participants who had anterior nares swab obtained for S. aureus culture) was analyzed for Screening Visit (SV) 1. Only subjects who had positive cultures for S. aureus at SV 1 were allowed to continue to SV 2 and 3. The Safety Population (participants who received at least one dose of study drug) was analyzed at Day 1.|||participants|||Number
1245767|NCT00539994|Secondary|Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12|Percentage of subjects that were recolonized on Day 12 (D12) and Day 33 (D33) that were negative (neg.) for S. Aureus in the Pharyngeal region on days 12 or 33 and Negative in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.|Days 7, 12, and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3 and those who were NEGATIVE for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.|||Percentage of participants|||Number
1245768|NCT00539994|Secondary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status|Comparison of nasal S. aureus eradication in persistent carrier subjects on 7, 12, and 33 days after treatment stratified by S. aureus carriage in the pharyngeal area|Days 1, 7, 12, and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and who were Persistent Nasal carriers who were both positive and negative carriers of S. aureus in the Pharyngeal region.|||Percentage of participants|||Number
1245769|NCT00539994|Secondary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus|Subjects who tested positive as persistent carriers of S. Aureus who on Days 7 and 33 are negative and have eradicated of S. aureus.|Days 7 and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visits 1, 2 and 3.|||Percentage of participants|||Number
1245770|NCT00539994|Secondary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5|Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.|Day 5|Per Protocol Population of Intent-to-treat|||hours||Standard Deviation|Mean
1245771|NCT00539994|Secondary|Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3|Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.|Days 1 and 3|Per Protocol Population of Intent-to-treat|||hours||Standard Deviation|Mean
1245772|NCT00539994|Primary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Day 12 Who Were Categorized as Persistent Carriers of S. Aureus|Subjects who tested positive as persistent carriers of S. Aureus who on day 12 are negative and have been eradicated of S. Aureus.|Day 12|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2 and 3.|||Percentage of participants|||Number
1245773|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma Cmax After Dosing|Cmax is the peak serum concentration. Low value was not calculable, and high value was 2.74 ng/mL|Day 5|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling|||ng/mL||Standard Deviation|Mean
1245774|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing|Cmax is the peak serum concentration. Low value was not calculable, and High value was 2.74 ng/mL.|Days 1 and 3|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling|||ng/mL||Standard Deviation|Mean
1245775|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma AUC After Dosing|Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.|Day 5|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling|||ng.h/mL||Standard Deviation|Mean
1246050|NCT00537771|Secondary|Incidence of Abnormal Liver Function|The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.|At 48 weeks, 96 weeks, 144 weeks||||participants|||Number
1245776|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing|Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.|Days 1 and 3|Pharmacokinetic (PK) Concentration Population - included all subjects who underwent plasma PK sampling|||ng.h /mL||Standard Deviation|Mean
1245777|NCT00539942|Secondary|Incidence of Untoward Effects With Arixtra|Adverse events will be evaluated to determine untoward effects.|21 days|Unable to analyze data.|||participants|||Number
1245778|NCT00539942|Primary|Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra|Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.|21 days|Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.|||participants|||Number
1245779|NCT00539864|Secondary|Percentage of Participants With Seroprotection|Percentage of participants with (HAI titer greater than or equal to 40) at Day 28|Day 28 following immunization at Day 0||||Percentage of participants||95% Confidence Interval|Number
1245780|NCT00539864|Secondary|Percentage of Participants With Seroconversion|Percentage of participants with greater than or equal to a 4-fold rise in Hemagglutination-Inhibition Assay (HAI) titer over Day 0 at Day 28 following immunization|Day 28 following immunization at Day 0|All randomized subjects who received study vaccine and who had day 0 and day 28 HAI titers|||Percentage of participants|Participants|95% Confidence Interval|Number
1245781|NCT00539864|Primary|Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)|Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.|Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization|Safety population included all randomized subjects who received a dose of study vaccine.|||participants|||Number
1245782|NCT00539864|Secondary|Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.|Immunogenicity was assessed by measuring the difference in values in Hemagglutination-Inhibition Assay (HAI) titers in participants from Day 0 to Day 28, using Geometric Mean Titers (GMTs). The GMTs from the FluBlok and TIV groups were then compared.|Day 0 and Day 28|All randomized subjects who received study vaccine and had Day 0 and Day 28 HAI titers|||HAI Titers||95% Confidence Interval|Geometric Mean
1245783|NCT00539734|Primary|Time to Response (Implicit Time) of Multifocal ERG Signal|Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.|baseline, 3 months||||millisecond|Participants|Standard Deviation|Mean
1245784|NCT00539734|Secondary|Postoperative Complication|For instance, Endophthalmitis, retinal detachment|1 month|||||||
1245785|NCT00539734|Primary|Height (Amplitude) of Multifocal ERG Signal|Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.|baseline, 3 months|Analysis was per protocol|||nanovolt/degree^2|Participants|Standard Deviation|Mean
1245786|NCT00539695|Other Pre-specified|Ancillary Studies|"To conduct ancillary studies on those patients to investigate before, during and after IL-2 administration to determine:~The immunophenotype of PBMCs~The suppressive activity of CD4+ CD25+ FoxP3+ Tregs~Cytokines secreted by PBMCs~NK cell analysis"|12 weeks|||||||
1245787|NCT00539695|Secondary|Percentage Change in CD4+ CD25+ FoxP3+ Regulatory T Cells (Tregs) From Pre to Post IL-2 Infusions|To investigate the immunomodulatory effects of IL-2 administered after allogeneic hematopoietic stem cell transplantation|12 weeks|Participants received low-dose IL-2 and had pre and post IL-2 Treg measurements.|||percentage||Inter-Quartile Range|Median
1245788|NCT00539695|Secondary|Rate of Severe (Grade III or IV) Acute GVHD|To determine the efficacy of low-dose IL-2 in the prevention of severe (grade III or IV) acute GVHD|Up to 12 weeks on low-dose IL-2|Participants received low-dose IL-2|||percentage of participants||95% Confidence Interval|Number
1245789|NCT00539695|Primary|Rate of Dose Limiting Toxicities|Assessment of the safety and the toxicity of low-dose IL-2, administered according to the dosage described in this protocol, in this group of patients The outcome measure is the proportion of participants with dose limiting toxicities.|6-12 weeks||||proportion of participants of DLT||95% Confidence Interval|Number
1245790|NCT00539617|Secondary|To Determine the Effects of Erlotinib on EGFR Signaling and Tumor Cell Survival in Esophageal Cancer.||2 years|||||||
1245791|NCT00539617|Secondary|To Estimate the Correlation of Epidermal Growth Factor Receptor (EGFR) Gene Amplification and EGFR Gene Expression Levels in Esophageal Cancer.||2 years|||||||
1245792|NCT00539617|Secondary|To Determine Toxicity and Tolerability of the Erlotinib and FOLFOX Treatment Regimen in the Selected Patient Population.||2 years|||||||
1245793|NCT00539617|Secondary|To Determine the Time to Progression in This Population After Initiation of Erlotinib Alone, Following Erlotinib and FOLFOX Combination Chemotherapy.||2 years|||||||
1245794|NCT00539617|Secondary|Response Rate (RR)|To determine the number of participants with partial response (PR) or stable disease (SD) for the objective tumor response rate in the selected patient population treated with erlotinib and FOLFOX.|2 years|Only 4 patients were eligible and started the the Run-In Phase on treatment.|||participants|||Number
1245795|NCT00539617|Primary|Progression Free Survival (PFS)|To determine the number of participants with progression free survival after 6 months form the first day of the Erlotinib Run-In Phase for patients treated on study.|2 years|Only 4 patients were eligible and started the Run-In Phase on treatment.|||participants|||Number
1245796|NCT00539591|Other Pre-specified|BRIEF Psychological Assessment (Stratum B)|The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.||||||
1245842|NCT00539279|Secondary|Sheehan Disability Scale (SDS)|The SDS is a self-report questionnaire about functioning. There are 3 scored items (Work/School; Social Life; and Family Life/Home Responsibilities), each with response categories from 0 (zero; Not at All) to 10 (Extremely). Thus, the total score ranges from 0 to 30. Higher scores reflect lower (poorer) levels of functioning.|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
1245797|NCT00539591|Other Pre-specified|BRIEF Psychological Assessment (Stratum A)|The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|This QOL analysis included patients only within Stratum A.|||T score||Standard Deviation|Mean
1245798|NCT00539591|Other Pre-specified|BASC-2 Psychological Assessment (Stratum B)|The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.||||||
1245799|NCT00539591|Other Pre-specified|BASC-2 Psychological Assessment (Stratum A)|The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|This QOL analysis included patients only within Stratum A.|||T score||Standard Deviation|Mean
1245800|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.|||units on a scale|||Number
1245801|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.|||units on a scale||Standard Deviation|Mean
1245802|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.|||units on a scale|||Number
1245803|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.|||units on a scale||Standard Deviation|Mean
1245804|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum B)|QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.|||units on a scale|||Number
1245805|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum A)|QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|This QOL analysis included patients only within Stratum A.|||units on a scale||Standard Deviation|Mean
1245806|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.|||units on a scale|||Number
1245807|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|This QOL analysis included patients only within Stratum A.|||units on a scale||Standard Deviation|Mean
1245808|NCT00539591|Other Pre-specified|Systemic Clearance (CL) of Interferon ɑ-2B|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.|||l/hr/m^2||Full Range|Median
1246051|NCT00537771|Primary|Incidence of Fatty Liver Disease|The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.|At 48 weeks, 96 weeks, 144 weeks||||participants|||Number
1245809|NCT00539591|Other Pre-specified|Volume of Central Compartment (Vc) of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.|||l/m^2||Full Range|Median
1245810|NCT00539591|Other Pre-specified|Half-Life of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.|||hours||Full Range|Median
1245811|NCT00539591|Other Pre-specified|Area Under the Curve (AUC) of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 to infinity.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic(PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.|||pcg * hr/ml||Full Range|Median
1245812|NCT00539591|Other Pre-specified|Apparent Clearance (CL) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis due to differences in clinical variables, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.|||ml/hr/kg||Full Range|Median
1245813|NCT00539591|Other Pre-specified|Volume of Central Compartment (Vc) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling due to differences in clinical variables. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.|||ml/kg||Full Range|Median
1245814|NCT00539591|Other Pre-specified|ɑ Half Life of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.|||hours||Full Range|Median
1245815|NCT00539591|Other Pre-specified|Area Under the Curve (AUC) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 through infinity."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.|||pcg * hr/ml||Full Range|Median
1245816|NCT00539591|Other Pre-specified|Median Steady State Trough Concentration of Pegylated Interferon ɑ-2B|"The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one patient had evaluable data in Stratum B and is not included in the final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling.|||pcg/ml||Full Range|Median
1245817|NCT00539591|Primary|Probability of Event-free Survival (EFS) of Stratum A Participants|The probability of EFS was estimated as time to first event (relapse, death or second malignancy). As of April 2016, 21 out of 23 participants had no events. The EFS rate was estimated by Kaplan-Meier method.|3 years from diagnosis||||probability||95% Confidence Interval|Number
1245843|NCT00539279|Primary|Patient Health Questionnaire Depression Subscale (PHQ-9)|"The PHQ-9 is a self-report questionnaire about depressive symptoms. There are 9 scored items, each with response categories from 0 (zero) to 3. Thus, the total score ranges from 0 to 27. Higher scores reflect higher levels of depressive symptoms, with interpretation as follows:~0 (zero) No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression"|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
1245818|NCT00539591|Primary|Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients|"The objective was to study the feasibility and safety of administering peginterferon a-2b weekly for 48 weeks following the initial induction phase to Stratum A participants.~Accrual was suspended during the 48-week course if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:~Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy~Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)~Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy~Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy~Grade 4 mood alteration (suicidal ideation; danger to self or others)"|52 weeks|Number of participants for the analysis was based on the intent to treat population, all patients enrolled were included. Participants were enrolled on Stratum A until the accrual goals were met on Stratum B.|||participants|||Number
1245819|NCT00539591|Primary|Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2|"The objective was to assess the safety of temozolomide administered in combination with peginterferon a-2b in Stratum B participants.~Accrual was suspended any time during therapy if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:~Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy~Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)~Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy~Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy~Grade 4 mood alteration (suicidal ideation; danger to self or others)"|52 weeks|This toxicity report was based on intention to treat population (ITT), all patients enrolled were included. The study did not meet its accrual goals within the planned timeframe due to slow accrual.|||participants|||Number
1245820|NCT00539591|Primary|Tumor Response Rate|Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease measurement compared to disease measurement at study entry with no new lesions detected. Progressive disease (PD) defined as at least 20% increase in the disease measurement compared to the smallest disease measurement recorded since start of treatment, or appearance of one or more new lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD compared to smallest disease measurement since start of treatment.|8 weeks||||participants|||Number
1245821|NCT00539539|Secondary|Ventilation Rate|Average ventilation rate (breaths/minute) during the first ten minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Ventilation rate available in 347 participants on the feedback on arm and 346 on the feedback off arm.|||breaths per minute||Standard Error|Mean
1245822|NCT00539539|Secondary|Percentage of Compressions With an Incomplete Release|Percentage of compressions with incomplete release during the first ten minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Incomplete release available for 529 participants on the feedback on arm and 467 on the feedback off arm.|||% of compressions w/ incomplete release||Standard Error|Mean
1245823|NCT00539539|Secondary|Compression Rate|Average compression rate during the first 10 minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Average compression rate available for 604 participants on the feedback on arm and 570 on the feedback off arm.|||Compressions per minute||Standard Error|Mean
1245824|NCT00539539|Secondary|Compression Depth|Average compression depth (mm) during the first 10 minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Compression depth available for 529 participants on the feedback on arm and 467 on the feedback off arm.|||mm||Standard Error|Mean
1245825|NCT00539539|Secondary|CPR Fraction|Percentage of time during CPR spend doing compressions.|Up to 10 minutes of CPR|Intention to treat, with CPR fraction available for 604 participants on the feedback on arm, and 570 on the feedback off arm.|||Percentage||Standard Error|Mean
1245826|NCT00539539|Secondary|Survival to Hospital Discharge|Survival to hospital discharge|Length of Hospitalization|Intention to treat, with survival to hospital discharge missing for one participant on the feedback off arm. Analysis included 815 participants on the feedback on arm, and 770 on the feedback off arm.|||Participants|||Number
1245827|NCT00539539|Secondary|Pulses Present at ED Arrival.||Resuscitation|Intention to treat. Presence of pulses not known for one participant on the feedback off arm. Analysis includes 815 participants on the feedback on arm and 770 on the feedback off arm.|||Participants|||Number
1245828|NCT00539539|Primary|Rate of ROSC During the Prehospital Resuscitation|Return of spontaneous circulation (ROSC)|Prehospital resuscitation|Intent to treat|||Participants|||Number
1245829|NCT00539526|Secondary|Change From Baseline in Tear Break-Up Time (TBUT) at Month 3|Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.|Baseline, Month 3||||Seconds||Standard Error|Mean
1245830|NCT00539526|Secondary|Change From Baseline in Corneal Staining With Fluorescein at Month 3|Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.|Baseline, Month 3||||Scores on a Scale||Standard Error|Mean
1245831|NCT00539526|Primary|Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3|Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.|Baseline, Month 3||||Scores on Scale||Standard Error|Mean
1245832|NCT00539513|Secondary|The Hamilton Depression Inventory (HAM-D)at 12 Weeks|"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression.~In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.~Ranges~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥23 = Very Severe Depression"|12 weeks|Participants that completed the study were analyzed|||units on a scale||Standard Deviation|Mean
1245833|NCT00539513|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at 12 Weeks|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.~Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme~In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity."|12 Weeks|Participants who completed the intervention were included in the analysis|||units on a scale||Standard Deviation|Mean
1245834|NCT00539513|Secondary|The Hamilton Depression Inventory (HAM-D)at Baseline|"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient’s level of retardation, and insight into their depression.~In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.~Ranges~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥23 = Very Severe Depression"|Baseline|Participants that completed the study were analyzed|||units on a scale||Standard Deviation|Mean
1245835|NCT00539513|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at Baseline|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive–compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.~Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0–7 = sub-clinical 8–15 = mild 16–23 = moderate 24–31 = severe 32–40 = extreme~In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity."|Baseline|Participants who completed the intervention were included in the analysis|||units on a scale||Standard Deviation|Mean
1245836|NCT00539305|Primary|Short-Form Health Survey (SF-36)|Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.|Baseline, Month 3, Month 6||||units on a scale||Standard Deviation|Mean
1245837|NCT00539305|Primary|Geriatric Depression Scale (GDS)|Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.|Baseline, Month 3, Month 6||||units on a scale||Standard Deviation|Mean
1245838|NCT00539305|Primary|Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test|Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.|Baseline, 3 and 6 months||||units on a scale||Standard Deviation|Mean
1245839|NCT00539305|Primary|Behavioral & Mood Measure: Profile of Mood States (POMS)|Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.|Baseline, 3 and 6 months|Vigor-Activity|||units on a scale||Standard Deviation|Mean
1245840|NCT00539279|Primary|Clinician-Administered PTSD Scale Severity Score (CAPS)|The CAPS is a clinician-administered interview about PTSD symptoms. There are 17 scored items for PTSD severity, each with response categories from 0 (zero) to 4 separately for both frequency and severity. Thus, each item can receive a score of 0 (zero) to 8, and the total severity score ranges from 0 to 136. Higher scores reflect higher levels of PTSD symptoms. Scores of 60 or above are generally considered clinically significant, and changes of 10 points or more (e.g., between pre-treatment and post-treatment) are considered clinically significant changes.|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
1245841|NCT00539279|Secondary|Global Neuropsychological Deficits (Standardized, Composite)|Among our battery of seven neuropsychological tests, we worked with our neuropsychologist to choose 13 key scales. We used a conversion system to equally weight areas where there were large deficits, even if there were only one or two deficits, to prevent such scores from being minimized among the large range of T scores for the other scales. We converted T scores as follows: >40 = 0; 35-39 = 1; 30-34 = 2; 25-29 = 3; 20-24 = 4; < 20 = 5. Higher scores mean a higher global cognitive deficit.|Pre-treatment, post-treatment||||standardized units on a scale||Standard Deviation|Mean
1245844|NCT00539279|Secondary|State-Trait Anxiety Inventory State Scale (STAI-S)|"The STAI-S is a self-report questionnaire about state (present state) anxiety. There are 20 scored items, each with response categories from 1 (Not at All) to 4 (Very Much So). Some items (e.g., I feel calm) are reversed scored so that the total score appropriately reflects state anxiety. Thus, the total score ranges from 20 to 80. Higher scores reflect higher levels of state anxiety."|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
1245845|NCT00539279|Secondary|Posttraumatic Cognitions Inventory (PTCI)|The PTCI is a self-report questionnaire about thoughts following traumatic events. There are 33 scored items, each with response categories from 1 (Totally Disagree) to 7 (Totally Agree), summed to create the total score. Thus, the total score ranges from 7 to 231. Higher scores reflect higher levels of negative cognitions.|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
1245846|NCT00539279|Primary|PTSD Checklist (PCL)|The PTSD Checklist is a self-report questionnaire about PTSD symptoms. The version used in this study is called the PCL-S, which denotes a specific traumatic event for subjects to respond to. There are 17 items, each with response categories from 1 to 5. Thus, the total score ranges from 17 to 85. Higher scores reflect higher levels of PTSD symptoms, and a score of 50 or above is commonly interpreted to designate clinically significant PTSD symptoms.|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Median
1245847|NCT00539253|Primary|Nodule Enhancement|Percent area of nodule with enhancement|3 month|Number of participants analyzed reflects the number of participants for whom data was available|||percent enhancement||Standard Deviation|Mean
1245848|NCT00539253|Primary|Nodule Size|Maximal nodule size measured in centimeters|3 months|The number of participants analyzed reflects the number of participants for whom data was available.|||centimeters||Standard Deviation|Mean
1245849|NCT00539240|Primary|Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better)|the number of days with Symptom Intensity Score < 3 (better) for acid regurgitation during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|ITT|||days||Standard Deviation|Mean
1245850|NCT00539240|Primary|Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline|the number of days with Symptom Intensity Score < 3 (better) for nighttime heartburn during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|ITT|||days||Standard Deviation|Mean
1245851|NCT00539240|Secondary|Health Related Quality of Life|SF-36 Physical Component Score (higher number better quality of life), is a measure of overall physical quality of life distinct from mental health. The range is 0 - 100. It has been adjusted to US national norms so that a score of 50 corresponds to the national mean.|end of study|ITT|||units on a scale||Standard Deviation|Mean
1245852|NCT00539240|Primary|Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better)|the number of days with Symptom Intensity Score < 3 (better) for daytime heartburn during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|intention to treat (ITT)|||days||Standard Deviation|Mean
1245853|NCT00539188|Secondary|Hamilton Depression Rating Scale (HAM-D) at Baseline|"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.~HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression~≥23 = Very Severe Depression~In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression."|Baseline||||units on a scale|||Number
1245854|NCT00539188|Primary|Self-Harm Inventory (SHI) Score at Baseline|"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever intentionally, or on purpose tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.~The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.~In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported."|Baseline||||units on a scale|||Number
1245855|NCT00539188|Secondary|Hamilton Depression Rating Scale (HAM-D) at 6 Weeks|"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient’s level of retardation, and insight into their depression. Highest possible score is 52.~HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression~≥23 = Very Severe Depression~In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression."|6 weeks||||units on a scale|||Number
1245868|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat|"Participants assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
1245856|NCT00539188|Primary|Self-Harm Inventory (SHI) Score at 6 Weeks|"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever “intentionally, or on purpose” tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.~The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.~In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported."|6 weeks||||units on a scale|||Number
1245857|NCT00539110|Secondary|Pharmacokinetics|evaluate the PK of zolpidem following standard dosing practices|2 weeks postburn|||||||
1245858|NCT00539110|Primary|Polysomnography Data|Determine if intervention product elicits more total sleep time|2 weeks postburn||||minutes||Standard Error|Mean
1245859|NCT00539032|Primary|Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.||Day 28 Post-vaccination|4-Fold rise in Menactra® vaccine antibodies were evaluated in the per-protocol population.|||Percentage of Participants|||Number
1245860|NCT00539032|Primary|Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.||Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination|Geometric mean titers by serum bactericidal assay were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1245861|NCT00539032|Other Pre-specified|Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®|Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.|Days 0-7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population.|||Participants|||Number
1245862|NCT00539006|Secondary|Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
1245863|NCT00539006|Secondary|Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
1245864|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist|Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
1245865|NCT00539006|Primary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor|"Participants assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Participants|||Number
1245866|NCT00539006|Primary|Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
1245867|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use|"Participants assessed preference over ease of use for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
1245869|NCT00538980|Secondary|Change in JAK2 Allele Burden|To determine if quantitative change in JAK2 expression occurs as measured by quantitative pyrosequencing. Analysis was not completed because the study was terminated early due to lack of efficacy.|JAK2 analysis will be performed at baseline and month 3.|||||||
1245870|NCT00538980|Secondary|Change in Cytogenetics|To determine change in cytogenetics if initially abnormal. Analysis was not completed because the study was terminated early due to lack of efficacy.|Cytogenetics analysis will be performed at baseline and month 6.|||||||
1245872|NCT00538980|Primary|Change in Performance Status and Development of Side Effects and Complications|To determine change in performance status and development of side effects and complications in patients treated under this protocol. Analysis was not completed because the study was terminated early due to lack of efficacy.|Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter.|||||||
1245873|NCT00538980|Primary|Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range|To evaluate the effect of dasatinib on the platelet count and the stabilization of hematocrit when restored by phlebotomy to normal range (HCT <45% for men, <42% for women). Analysis was not completed because the study was terminated early due to lack of efficacy.|Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.|||||||
1245874|NCT00538915|Primary|Serious Bacterial Infections (SBIs) Compared to Historical Control Data.|Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.|One year|63 subjects enrolled, received treatment and included in the Safety population. 5 subjects excluded from the Intent To Treat (ITT) population due to significant, excessive protocol violations and an insufficient number of infusions to elicit the intended effect.|||SBIs Per Total Person-Years|||Number
1245875|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||score on a scale||Standard Deviation|Mean
1245876|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||score on a scale||Standard Deviation|Mean
1245877|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Double-Blind portion of the study), Observed cases included.|||score on a scale||Standard Deviation|Mean
1245878|NCT00538902|Secondary|Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period|HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties).|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||score on a scale||Standard Deviation|Mean
1245879|NCT00538902|Secondary|Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period|HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period.|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).|||score on a scale||Standard Deviation|Mean
1245908|NCT00538785|Primary|Number of Subjects Reporting Serious Adverse Events Through Study Day 150|Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-150|The Safety population included all subjects who received any study drug and had any safety follow-up.|||participants|||Number
1245880|NCT00538902|Secondary|Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||mm||Standard Deviation|Mean
1245881|NCT00538902|Secondary|Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||mm||Standard Deviation|Mean
1245882|NCT00538902|Secondary|Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||mm||Standard Deviation|Mean
1245883|NCT00538902|Secondary|Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period.|Baseline, Week 12|Intent-to-Treat (ITT) population (all subjects who received at least 1 dose of study drug during the double-blind period), Last Observation Carried Forward (LOCF).|||mm||Standard Deviation|Mean
1245884|NCT00538902|Secondary|Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Joints||Standard Deviation|Mean
1245885|NCT00538902|Secondary|Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Joints||Standard Deviation|Mean
1245886|NCT00538902|Secondary|Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).|||Joints||Standard Deviation|Mean
1245909|NCT00538785|Primary|Number of Subjects Reporting Adverse Events Through Study Day 150|Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.|Days 0-150|The Safety population included all subjects who received any study drug and had any safety follow-up.|||participants|||Number
1245887|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Participants|||Number
1245888|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Participants|||Number
1245889|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Participants|||Number
1245890|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period|American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period.|Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), non-responder imputation (NRI; missing ACR responses imputed as non-responders).|||Participants|||Number
1245891|NCT00538902|Primary|Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period|American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.|Week 12|Intent-to-treat population (ITT): all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study.|||Participants|||Number
1245892|NCT00538863|Primary|Percentage of Patients That Experienced 1 or More Adverse Events||Baseline to end of the study (up to 116 days)|Safety population: All patients who received study medication.|||Percentage of patients|||Number
1245893|NCT00538850|Secondary|Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing|Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.|30 through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.|||Units on a scale||Standard Deviation|Mean
1245894|NCT00538850|Secondary|Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing|Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5*PAR5), TOTPAR10=(5*PAR5)+(5*PAR10), TOTPAR15=(5*PAR5)+(5*PAR10)+(5*PAR15), TOTPAR30=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30), TOTPAR45=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30)+(15*PAR45), TOTPAR60=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30) +(15*PAR45) +(15*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.|5 through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.|||Units on a scale||Standard Deviation|Mean
1245976|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|90 days||||mm Hg||Standard Deviation|Mean
1245895|NCT00538850|Secondary|Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing|Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented “no pain” and 100 represented “worst possible pain” at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5*PID5), SPID10=(5*PID5)+(5*PID10), SPID15=(5*PID5)+(5*PID10)+(5*PID15), SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30), SPID45=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30)+(15*PID45), SPID60=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30) +(15*PID45) +(15*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.|Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.|||Units on a scale||Standard Deviation|Mean
1245896|NCT00538850|Primary|Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)|Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented “no pain” and 100 represented “worst possible pain” at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.|Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.|||Units on a scale||Standard Deviation|Mean
1245897|NCT00538824|Primary|Effect of Drug Combination on Multiple Myeloma|The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/|The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks||||participants|||Number
1245898|NCT00538785|Secondary|Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass|Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.|Days 0-150|Evaluable for PK following cardiac surgery with cardiopulomonary bypass; all motivizumab treated subjects who underwent cardiac surgery with cardiopulmonary bypass and who received the correct dose regiment.|||ug/mL||Standard Deviation|Mean
1245899|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4|30 days post-dose 4|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
1245900|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3|30 days post-dose 3|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
1245901|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2|30 days post-dose 2|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
1245902|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1|30 days post-dose 1|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
1245903|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at Pre-dose 1|Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1|Pre-dose 1|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
1245904|NCT00538785|Secondary|Number of Subjects Who Had Anti-motavizumab Antibodies Detected|ECLA-based method|Days 0-150|Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug.|||participants|||Number
1245905|NCT00538785|Secondary|The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.|An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.|Days 0-150|All subjects who were randomized in Season 2|||participant|||Number
1245906|NCT00538785|Secondary|The Number of Subjects Hospitalized for RSV Infection.|An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).|Days 0-150|The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study.|||participants|||Number
1245910|NCT00538733|Secondary|Progression Free Survival|"Progression determined using International Myeloma Working Group criteria, as defined below.~An increase of > 25% from lowest response value one or more of the following:~Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*~Urine M-component and/or (the absolute increase must be > 200 mg/24 h)~Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL~Bone marrow plasma cell percentage; the absolute percentage must be > 10%~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder *if starting serum M protein is greater then 5 g/dL, absolute increase of 1g/dL is sufficient to determine relapse."|From start of treatment, to the date of first progression|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.|||months||95% Confidence Interval|Median
1245911|NCT00538733|Secondary|Event Free Survival||from baseline to the time of first event that lead to removal from study (defined as progression, death, withdrawal of consent, or removal for toxicity)||||months||95% Confidence Interval|Median
1245912|NCT00538733|Secondary|Median Time to Maximum Response|Median Time to maximum response, reported in cycles of treatment. One cycle = 28 days.|from baseline to cycle with maximum response|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.|||cycles||Full Range|Median
1245913|NCT00538733|Primary|Effect of Drug Combination on Multiple Myeloma|Objective response rate, defined according to the International Myeloma Working Group (IMWG) criteria as greater then or equal to a Partial Response (PR). The best response was recorded. The IMWG criteria can be found here: imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/|This was collected from patients for their duration on study treatment. Only the best response was recorded. Best responses were reported at any point of the study, from start of treatment up until removal of study, which occurred up to 57.4 cycles|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.|||participants|||Number
1245914|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|4-5 months||||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
1245915|NCT00538642|Secondary|LDL Cholesterol||4-5 months||||mg/dL||Standard Deviation|Mean
1245916|NCT00538642|Secondary|LDL Cholesterol||Baseline||||mg/dL||Standard Deviation|Mean
1245917|NCT00538642|Secondary|HDL Cholesterol||4-5 months||||mg/dL||Standard Deviation|Mean
1245918|NCT00538642|Secondary|HDL Cholesterol||Baseline||||mg/dL||Standard Deviation|Mean
1245919|NCT00538642|Secondary|Cholesterol||4-5 months||||mg/dL||Standard Deviation|Mean
1245920|NCT00538642|Secondary|Cholesterol||Baseline||||mg/dL||Standard Deviation|Mean
1245921|NCT00538642|Secondary|Triglycerides||4-5 months||||mg/dL||Standard Deviation|Mean
1245922|NCT00538642|Secondary|Triglycerides||Baseline||||mg/dL||Standard Deviation|Mean
1245923|NCT00538642|Secondary|Diastolic Blood Pressure||4-5 months||||mm Hg||Standard Deviation|Mean
1245924|NCT00538642|Secondary|Diastolic Blood Pressure||Baseline||||mm Hg||Standard Deviation|Mean
1245925|NCT00538642|Secondary|Systolic Blood Pressure||4-5 months||||mm Hg||Standard Deviation|Mean
1245926|NCT00538642|Secondary|Systolic Blood Pressure||Baseline||||mm Hg||Standard Deviation|Mean
1245927|NCT00538642|Secondary|Abdominal Circumference||4-5 months||||cm||Standard Deviation|Mean
1245928|NCT00538642|Secondary|Abdominal Circumference||Baseline||||cm||Standard Deviation|Mean
1245929|NCT00538642|Secondary|Body Mass Index||4-5 months||||Kg/m2||Standard Deviation|Mean
1245930|NCT00538642|Secondary|Body Mass Index||Baseline||||Kg/m2||Standard Deviation|Mean
1245931|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|Baseline||||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
1245932|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245933|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline to final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245934|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245935|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia and who had received at least 1 dose of study medication.|||Participants|||Number
1245977|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|180 days||||mm Hg||Standard Deviation|Mean
1245936|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245937|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245938|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245939|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245940|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245941|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245942|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245943|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245944|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245945|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245946|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245947|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245948|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245978|NCT00538590|Secondary|Complications|Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.|360 days||||percentage of participants||Standard Deviation|Mean
1245949|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245950|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245951|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245952|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication|||Participants|||Number
1245953|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245954|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245955|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245956|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245957|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245958|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication|||Participants|||Number
1245959|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.|||Participants|||Number
1245960|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.|||Participants|||Number
1245961|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.|||Participants|||Number
1245979|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|360 days||||mm Hg||Standard Deviation|Mean
1245962|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245963|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245964|NCT00538629|Primary|Global Efficacy Evaluation Scores (Schizophrenia Population)|The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on schizophrenia symptoms using a 5-point scale that ranges from very good to worsening of the original disease.|Final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
1245965|NCT00538629|Primary|Global Efficacy Evaluation Scores (Bipolar Population)|The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on bipolar symptoms using a 5-point scale that ranges from very good to worsening of the original disease.|Final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245966|NCT00538629|Primary|Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit|EPS assesses 4 items: akathisia, dystonia, dyskinesia, and parkinsonism. Each item is scored on a 5-point severity scale ranging from 1 to 5, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.|||Score on scale||Standard Deviation|Mean
1245967|NCT00538629|Primary|Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline|BPRS is an 18-item scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items. The physician completes the BPRS, and each item is scored on a 7-point scale, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.|Baseline to final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.|||Score on scale||Standard Deviation|Mean
1245968|NCT00538629|Primary|Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)|CGI-C assesses change in severity of the condition using a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.|Final visit (week 12)|The schizophrenia full analysis set included all subjects who had been diagnosed with schizophrenia and had received at least 1 dose of study medication.|||Participants|||Number
1245969|NCT00538629|Primary|Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)|CGI-C assesses change in severity of the condition using a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.|Final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245970|NCT00538629|Primary|Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline|MADRS measures treatment effect on depression severity. MADRS assesses apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Higher score indicates greater severity of disease. Change: score at final visit minus score at baseline.|Baseline to final visit (12 weeks)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.|||Score on scale||Standard Deviation|Mean
1245971|NCT00538629|Primary|Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline|The YMRS is an 11-item questionnaire that rates the severity of bipolar disorder, with higher score indicating greater severity of disease. Change: score at final visit minus score at baseline.|Baseline to final visit (12 weeks)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If the final visit measurement was missing, the follow-up measurement could be carried forward. If any individual item was missing, the total score was set to missing.|||Score on scale||Standard Deviation|Mean
1245972|NCT00538629|Primary|Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)|CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.|Baseline|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication|||Participants|||Number
1245973|NCT00538629|Primary|Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)|CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.|Baseline|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
1245974|NCT00538616|Primary|Lactate/Pyruvate (L/P)Ratio|L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.|1 hour||||ratio||Standard Deviation|Mean
1245975|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|30 days||||mm Hg||Standard Deviation|Mean
1245980|NCT00538512|Secondary|Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.|Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection).|Time between prevaccination and postvaccination, typically about 30 days.|Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.|||Participants|||Count of Participants
1245981|NCT00538512|Secondary|Immune Response to Vaccination and Infection|Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit.|Postvaccination to postseason visit; typically about 3 months.|Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.|||Participants|||Count of Participants
1245982|NCT00538512|Secondary|Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection|Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit.|Time between prevaccination visit and postvaccination visit; typically about 30 days.|Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.|||Participants|||Count of Participants
1245983|NCT00538512|Primary|Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza||one influenza season - 2007-2008|ITT|||participants|||Number
1245984|NCT00538473|Secondary|Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains|Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1245985|NCT00538473|Secondary|Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains|Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1245986|NCT00538473|Secondary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1245987|NCT00538473|Secondary|Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||fold increase||95% Confidence Interval|Mean
1245988|NCT00538473|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1246040|NCT00537823|Secondary|Liver Injury Scale Score (0-27)||Time of surgery (approximately 11-16 weeks)|Data was not collected for this outcome measure as the study pathologist left the institution early prior to study closure.||||||
1247018|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea|4 weeks|FAS using imputed values|||Unit on a Scale||Standard Error|Mean
1245989|NCT00538473|Secondary|Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1245990|NCT00538473|Secondary|Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1245991|NCT00538473|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.|Throughout the entire study (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1245992|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1245993|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1245994|NCT00538473|Primary|Duration of Solicited General Symptoms|Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.|||Days||Full Range|Median
1245995|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1245996|NCT00538473|Primary|Duration of Solicited Local Symptoms|Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.|||Days||Full Range|Median
1245997|NCT00538473|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
1245998|NCT00538434|Secondary|Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)|CHQ is a quality-of-life (QoL), observer-rated (the parent in this study) instrument designed to assess the general health and well-being of pediatric subjects aged 5 to 18 years. The instrument comprises 50 items that cover 14 unique physical and psychological concepts. Each item was scored separately following different scales and timeframes for response. Proprietary scoring algorithms are used. This outcome reports the two CHQ Summary Scores (Physical Summary Score and the Psychosocial Summary Scores) which are indexed to a 0 (poorest quality of life) to 100 (best quality of life) scores. The two summary scores are subsequently combined (via proprietary algorithm) to create the Global Health Summary Score (also on a 0-100 scale). Percent change from baseline values range from 100% (poorest QoL at baseline, best QoL at end of treatment) to -100% (best QoL at baseline, poorest QoL at end of treatment). Higher percent change from baseline values indicate improved QoL.|Baseline, End of Treatment (up to 15 weeks +/- 4 days)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment; n=number of participants with a response in the given category.|||percentage change in score||Standard Deviation|Mean
1246041|NCT00537823|Secondary|Nonalcoholic Steatohepatitis Score (0-3)|"NASH Scoring~Steatosis **<5% = 0~**5-33%=1~**>33-66%=2~**>66%=3~Lobular inflammation~**No foci=0~**<2 foci per x 200 field=1~**2-4 foci per x 200 field=2~**>4 foci per x 200 field=3~Hepatocellular ballooning **None=0 **Few balloon cells = 1 **Many cells/prominent ballooning=2"|Time of surgery (approximately 11-16 weeks)|"4 participants did not have surgery and are not included in this outcome measure.~The study pathologist left the university early prior to completion of study pathology for this study."|||participants|||Number
1245999|NCT00538434|Secondary|Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment|Participants rated the severity of each EE symptom (vomiting/regurgitation, abdominal/chest pain, and dysphagia) based on the previous week’s daily diary as none (=0), mild, moderate, severe, or very severe (=4). The predominant symptom was selected at the baseline visit and remained the same throughout the trial. The predominant symptom was defined as the EE symptom that had the greatest negative impact on the participant. The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Patient's EE Predominant Symptom Assessment indicate improvement in the selected symptom.|Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.|||units on a scale||Standard Deviation|Mean
1246000|NCT00538434|Primary|Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)|"The investigator completed the Physician’s EE Global Assessment based upon the participant’s reporting of symptoms, weight, dietary status, and overall well-being. The assessment rated severity on a five-point scale (0=none to 4=very severe), taking into account physical findings, vital signs, the Subject’s Predominant EE Symptom Assessment, the subject’s diary data, and dietary questions. The Subject's Predominant EE Symptom was the EE symptom (vomiting/regurgitation, abdominal/chest pain, or dysphagia) that had the greatest negative impact on the subject based on patient diary data as of the baseline visit.~The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Physician's EE Global Assessment indicate improvement in EE status."|Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.|||units on a scale||Standard Deviation|Mean
1246001|NCT00538434|Primary|Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels|Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.|Baseline, End of Treatment (up to 15 weeks [+/- 4 days])|ITT population: all randomized participants who received any amount of study drug.|||percentage change in eosinophils/hpf||Standard Deviation|Mean
1246002|NCT00538304|Secondary|Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1|Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked “Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?”. The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor’s office told them to expect.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Percentage of Patients|||Number
1246003|NCT00538304|Secondary|Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1|Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked “Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?”. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Percentage of Patients|||Number
1246004|NCT00538304|Secondary|Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1|Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked “Overall, based on how well this drug lowered THIS patient’s IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?”. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Percentage of Physicians|||Number
1246005|NCT00538304|Secondary|Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1|Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1246006|NCT00538304|Secondary|Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1|Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient’s visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Percentage of Patients|||Number
1246042|NCT00537823|Secondary|Histologic Hepatic Toxicity at Surgery||Time of surgery (approximately 11-16 weeks)|4 participants did not have surgery.|||participants|||Number
1246007|NCT00538304|Primary|Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1|Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient’s visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.|Baseline, Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Number on a scale (score)||Standard Deviation|Mean
1246008|NCT00538291|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Assessment after every 2 cycles of treatment, up to 1 year.|The three patients not completing at least two courses of treatment were considered treatment failures and were included in efficacy analysis.|||number of responding participants|||Number
1246009|NCT00538213|Secondary|The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker|The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were CD8-All doubles, CD40L, IFN-γ, IL-2 and TNF-α.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||CD8 cells/10^6 CD8+ cells||Standard Deviation|Geometric Mean
1246010|NCT00538213|Secondary|The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker|The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD40 Ligand (CD40L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||CD4 cells/10^6 CD4+ cells||Standard Deviation|Geometric Mean
1246011|NCT00538213|Secondary|The Number of Subjects Seroprotected to HI Antibodies|Seroprotection was defined as serum HI titer ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||subjects|||Number
1246012|NCT00538213|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||fold increase||95% Confidence Interval|Geometric Mean
1246013|NCT00538213|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||subjects|||Number
1246014|NCT00538213|Secondary|The Number of Subjects Seropositive to HI Antibodies|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e. ≥ 1:10. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||subjects|||Number
1246015|NCT00538213|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
1246016|NCT00538213|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1246017|NCT00538213|Primary|Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1246043|NCT00537823|Secondary|Postoperative Recurrence Patterns|Liver only vs distant disease|Up to 5 years|7 participants were not evaluable. 4 participants did not have surgery (3 in Arm 1, 1 in Arm 2). 1 participant had surgery but was not resectable (Arm 1) . 1 participant developed another primary cancer (Arm 1). 1 participant died before recurrence from hepatic failure (Arm 1).|||participants|||Number
1246018|NCT00538213|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1246019|NCT00538213|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1246020|NCT00538213|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1246021|NCT00538213|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1246022|NCT00538213|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. >100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1246023|NCT00537979|Secondary|Health-related Quality of Life With Paricalcitol Injection or Oral Treatment|Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.|Baseline and 24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.|||Participants|||Number
1246024|NCT00537979|Secondary|Duration of Response to Treatment|Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.|24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.|||days||Standard Deviation|Mean
1246025|NCT00537979|Secondary|Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level|Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.|24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.|||days||Standard Deviation|Mean
1246026|NCT00537979|Secondary|Proportion of Subjects Who Achieve an iPTH <300 pg/mL|Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.|24 weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.|||participants|||Number
1246027|NCT00537979|Secondary|Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)|Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.|24 Weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.|||participants|||Number
1246028|NCT00537979|Primary|Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level|Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.|24 weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.|||participants|||Number
1246029|NCT00537940|Secondary|Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specifictime points for each arm group, respectively.|||percentage of participants|||Number
1246044|NCT00537823|Primary|All-cause Mortality||30 days following surgery|4 participants did not have surgery.|||participants|||Number
1246030|NCT00537940|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) Score.|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity (range:0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except adequacy, optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range:0-100; higher score=more intensity of attribute.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.|||Units on a scale||Standard Error|Least Squares Mean
1246031|NCT00537940|Secondary|Hospital Anxiety and Depression Scale (HADS) Score.|HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||Units on a scale||Standard Error|Least Squares Mean
1246032|NCT00537940|Secondary|Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.|SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n is the number of participants analyzed for SGTC. Twenty-six participants were not included in the n because they did not have a post Baseline all partial seizure, but they were included in the analysis by seizure type.|||percentage of responders||95% Confidence Interval|Number
1246033|NCT00537940|Secondary|Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.|Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of all partial seizure/28days||Standard Deviation|Mean
1246034|NCT00537940|Secondary|Percentage of Participants Without Seizures.|Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1246035|NCT00537940|Secondary|Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.|Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline <= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of participants that can be analyzed for each treatment group.|||Percentage of participants||95% Confidence Interval|Number
1246036|NCT00537940|Secondary|Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.|Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline <= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of subjects that can be analyzed for each treatment group.|||Percentage of participants||95% Confidence Interval|Number
1246037|NCT00537940|Primary|Percent Change From Baseline in 28-day Seizure Frequency at Week 21.|The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant’s 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure [SGTC]).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.|||percent change||Full Range|Median
1246038|NCT00537823|Secondary|Change in Tumor Size From Pretreatment to Preoperative CT Scan|-Compare total longest diameter from baseline to preoperative CT scan.|Completion of neoadjuvant therapy (approximately 8 weeks)|2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.|||percentage of change of longest diameter||Full Range|Median
1246039|NCT00537823|Secondary|Effect of Preoperative Chemotherapy on Tumor Size|Number of participants whose tumor size decreased from baseline to completion of preoperative chemotherapy.|Upon completion of neoadjuvant chemotherapy (approximately 2 months)|2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.|||participants|||Number
1246052|NCT00537745|Primary|% Days w/1+Interlock Test Failures|This describes the percent of days in past month where the subject at least 1 interlock test failure.|One month post treatment|Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.|||percent of days||Full Range|Mean
1246053|NCT00537745|Primary|Evidence of Attempts to Drive After Drinking|"This was measured as Percent of days with an Interlock report of Failure to Start due to alcohol pre/on medication and 6 months post medication."|6 months|Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.|||percent of days|Participants|Full Range|Mean
1246054|NCT00537680|Secondary|FACT|Friedreich’s Ataxia Composite Test|6 Months|||||||
1246055|NCT00537680|Secondary|ADL of FARS|ADL=Activities of Daily Living|6 Months|||||||
1246056|NCT00537680|Secondary|FARS|Friedreich’s Ataxia Rating Scale|6 Months|||||||
1246057|NCT00537680|Primary|ICARS|"International Cooperative Ataxia Rating Scale (ICARS):~ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability.~Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst)."|baseline and 6 months||||ICARS points||Standard Deviation|Mean
1246058|NCT00537511|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. 'Related' = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.|Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).|Safety population; participants continuing in the Recovery Period and Maintenance Phase.|||participants|||Number
1246059|NCT00537511|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant’s health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.|Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).|Safety population|||participants|||Number
1246060|NCT00537511|Secondary|Overall Survival|Overall Survival was defined as time (in weeks) from enrollment to death. The median is based on Kaplan-Meier estimate, with 95% confidence intervals about the median overall survival. Overall survival was censored at the last time participant was known to be alive for those who were alive at time of analysis.|From enrollment through study termination (approximately 35 months)|Participants in the ITT population.|||weeks||95% Confidence Interval|Median
1246061|NCT00537511|Secondary|Duration of Response|Duration of Response was calculated from first Partial Response (PR) or Complete Response (CR) to disease progression. Duration of response was censored at the last date that the participant was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had been removed from the treatment phase prior to documentation of progression.|From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)|Number of participants in ITT population who were considered Responders.|||weeks||Standard Deviation|Mean
1246062|NCT00537511|Secondary|Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)|Investigator's best assessment of response based on RECIST criteria during the MTD phase. For target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Cycles 1 -6 (21-day cycles)|ITT population. 'Not Assessed' category includes participants who did not have adequate data for response assessment at baseline and/or post-baseline prior to the use of any non-protocol anti-tumor therapy.|||participants|||Number
1246077|NCT00537407|Secondary|Percentage of Participants With an Early Viral Response at Week 12|A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline.|Baseline to Week 12|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||percentage of participants|||Number
1246063|NCT00537511|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase|For the purposes of determining the MTD (see Primary Outcome Measure), a DLT was defined as any 1 or more of the following: inability to deliver all 3 doses of cisplatin and etoposide due to toxicity; inability to deliver 14 consecutive days of daily pomalidomide dosing because the participant did not tolerate the medication due to any of the following: ≥ grade 3 non-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count [ANC] <1,000/µL and fever >101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count <25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.|Cycles 1 - 6 (21-day cycles)|Safety Population|||participants|||Number
1246064|NCT00537511|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)|Cycle 1 (21 days)|Safety Population|||mg|||Number
1246065|NCT00537485|Secondary|The Modified Hoehn and Yahr Stage|Mean change (LOCF) from baseline in the Modified Hoehn and Yahr Severity of Illness at the end of maintenance period. The Modified Hoehn and Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.|Baseline, end of maintenance period|FAS, LOCF|||Percentage of participants|||Number
1246066|NCT00537485|Secondary|Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4|"Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 1, 2, 3 and 4.~UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1246067|NCT00537485|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score at every two weeks after dosing.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1246068|NCT00537485|Secondary|UPDRS Part 1 Sum Score|"MMean change (LOCF) from baseline in UPDRS Part 1 sum score at every two weeks after dosing.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1246069|NCT00537485|Secondary|Efficacy Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.|Baseline, every two weeks|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
1246070|NCT00537485|Secondary|UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at every two weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1246071|NCT00537485|Secondary|Efficacy Rate in UPDRS Part 2 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.|Baseline, every two weeks||||Percentage of participants||95% Confidence Interval|Number
1246072|NCT00537485|Secondary|Mean Change in UPDRS Part 2 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score at every two weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks||||Scores on a scale||Standard Deviation|Mean
1246073|NCT00537485|Secondary|Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in total of each sum score of UPDRS Part 2 and Part 3 at the end of maintenance period|baseline, end of maintenance period|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
1246074|NCT00537485|Primary|Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3|"Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, end of maintenance period|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1246075|NCT00537407|Secondary|Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96)|A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL).|24 weeks after the end of treatment (Week 72 or 96)|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||percentage of participants|||Number
1246076|NCT00537407|Secondary|Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)|A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL).|End of treatment (Week 48 or 72)|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||percentage of participants|||Number
1246078|NCT00537407|Secondary|Percentage of Participants With a Rapid Viral Response at Day 29|A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL).|Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||percentage of participants||95% Confidence Interval|Number
1246079|NCT00537407|Secondary|log10 Hepatitis C Virus RNA at Day 29|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||Log10(IU/mL)||Standard Deviation|Mean
1246080|NCT00537407|Secondary|Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Baseline to Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||Log10(IU/mL)||Standard Deviation|Mean
1246081|NCT00537407|Primary|Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Baseline to Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||Log10(IU/mL)||Standard Deviation|Mean
1246082|NCT00537394|Secondary|Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure|Defined among the subgroup of participants experiencing the outcome of confirmed virologic failure. Newly acquired HIV drug resistance is defined as one or more ARVs with partial resistance or resistance when pre-entry resistance was fully sensitive or resistant when pre-entry resistance was fully sensitive or partially sensitive. The ARVs included for resistance acquisition included the following: darunavir/ritonavir; etravirine, tipranavir, tenofovir, emtracitabine, lamivudine, zidovudine, abacavir.|Between baseline and confirmed virologic failure (up to 96 weeks)|Those with confirmed virologic failure (N=54; N=50) among the randomized arms included; and those who were missing resistance information following virologic failure (N=2; N=4) are excluded.|||participants|||Number
1246083|NCT00537394|Secondary|Change in Fasting Non-HDL Cholesterol From Baseline|Fasting non-HDL cholesterol calculated from difference between fasting total cholesterol and fasting HDL level. Missing values and non-fasting values excluded.|From study entry to Weeks 24, 48|All randomized participants who started study treatment. Non-fasting results and missing results excluded from analysis. Therefore, differences reported here represent a complete case analysis.|||mg/dL||Standard Deviation|Mean
1246084|NCT00537394|Secondary|Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry|HIV Co-receptor tropism test result of either dual/mixed or evidence of X4 using virus from sample collected at confirmed virologic failure.|From study entry to time of confirmed virological failure (up to 96 weeks)|Only randomized participants with R5-tropic virus at study entry (N=89; N=88), and who experienced confirmed virologic failure (N=27; N=22) during follow-up, and who had a tropism test following failure are included.|||participants|||Number
1246085|NCT00537394|Secondary|Time From Treatment Dispensation to Serious Non-AIDS-defining Events|Serious Non-AIDS defining Events were adjudicated by independent and blinded review and possible events included serious diagnoses in the following disease areas: liver, cardiovascular, end-stage renal, non-AIDS malignancy, and diabetes mellitus. Week 96 study visit could take place up to 110 weeks following randomization. Event times were the exact weeks following treatment initiation corresponding to the diagnosis dates of the qualifying serious non-AIDS defining events. Censoring times were the weeks following treatment initiation corresponding to the latest study visit.|From treatment initiation to week 96 study visit|Randomized participants were included, and those not starting study treatment were excluded.|||weeks||95% Confidence Interval|Number
1246086|NCT00537394|Secondary|Change in CD4 Count From Baseline|Baseline CD4 calculated as average of pre-entry and entry values. Closest observed result between 42 and up to 54 weeks (for week 48) or between 90 and up to 110 weeks (for week 96), used if multiple results available. Missing values excluded.|From study entry to Weeks 48 and 96|All subjects in the two randomized arms were assessed.|||cells/mm^3||Inter-Quartile Range|Median
1246087|NCT00537394|Secondary|Change in Cardiovascular Risk Score From Baseline|Cardiovascular risk score defined by Framingham providing an estimate of the probability of developing cardiovascular disease over the next 10-year period. Persons with a historical cardiovascular event (CAD, cerebro- or peripheral- vascular disorder, MI or stroke), were excluded, and scores were not calculated at follow-up times after individuals had a cardiovascular event. Missing values for input data (e.g. smoking status) resulted in a missing value for Framingham score.|At Weeks 24, 48, and 96|Persons not starting treatment (N=1; N=2), who had cardiovascular disease prior to study entry (N=12; N=8), or were missing input values needed to calculate a baseline Framingham score (N= 6; N=4), were excluded.|||units on a scale||Standard Deviation|Mean
1246088|NCT00537394|Secondary|Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable)|Results represent self-report of non-adherence during the 4-day period prior to the outcome evaluation visit. Participants in follow-up for whom these data are missing for any reason are inferred as not-adherent.|At Weeks 24 and 48|Persons not starting study treatment, or not receiving assigned study treatment by randomization were excluded from all analyses. If person no longer in study follow-up before beginning of week 24 or 48 evaluation window, additionally excluded as applicable.|||participants|||Number
1246089|NCT00537394|Secondary|Change in Summarized Quality of Life Score|Quality-of-life score at each evaluation based upon a single question assessing participants' self-report of general health with a range of 0 (representing worst health status) to 100 (representing perfect health).|At study entry and Weeks 24, 48, 96|Two randomized arms only.|||units on a scale||Inter-Quartile Range|Median
1246090|NCT00537394|Secondary|Change in Plasma HIV-1 Viral Load From Baseline to Week 1|Method of Kaplan and Meier used to accommodate left-censoring for those whose week 1 levels < 50 copies/mL.|From baseline to Week 1 evaluation|Modified intent to treat population among two randomized arms only: 2 participants (both in Omit NRTIs arm) were excluded because their baseline and week 1 RNA levels were both < 50 copies/mL.|||log10 copies/mL||Inter-Quartile Range|Median
1246091|NCT00537394|Secondary|Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml|Number of participants with plasma HIV-1 Viral load < 50 copies/mL at study visit weeks 24, 48, and 96. Closest observed result between 20 and up to 30 weeks (for week 24), between 42 and up to 54 (for week 48), and between 90 and up to 110 (for week 96) used if multiple results available. Missing values excluded.|At Weeks 24, 48, 96|ITT - among 2 randomized arms only; closest value to scheduled week used if multiple values available; missing values excluded. Numbers analyzed at each time point represent those with a valid RNA result.|||participants|||Number
1246092|NCT00537394|Secondary|Time From Randomization to Confirmed Virological Failure|Virologic failure defined as confirmed (two consecutive) plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Event time was the scheduled study visit week when the initial plasma HIV-1 RNA specimen meeting the failure definition was collected. Censoring time was the latest scheduled study visit week when a plasma HIV-1 RNA specimen was collected and tested.|From randomization to week 96 study visit|ITT (all randomized participants) included.|||weeks||95% Confidence Interval|Number
1246093|NCT00537394|Secondary|Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment|Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for meeting this outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Event times were scheduled study weeks when discontinuation events occurred. Censoring times were latest scheduled study visit weeks with evaluation.|From randomization to week 96 study visit|All randomized participants included (i.e. ITT analysis).|||weeks||95% Confidence Interval|Number
1246094|NCT00537394|Secondary|Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable)|First study ARV modification included any discontinuation or substitution of any chosen and initiated ARV for any reason. Events prompting study medication change could include protocol required (e.g. safety), protocol recommended but not required (e.g. virologic failure), or participant motivated (such as non-adherence, loss to follow-up or death; in other words, not protocol recommended or required). Event times were the exact weeks from treatment initiation to the time of qualifying regimen modification. Censoring times were the exact weeks from treatment initiation to the last date of study drugs. The week 96 (final study visit) could occur up through 110 weeks following randomization.|From treatment dispensation to week 96 study visit|Only randomized participants included, and those who never started study treatment were excluded.|||weeks||95% Confidence Interval|Number
1246095|NCT00537394|Secondary|Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality|Events following permanent discontinuation of NRTI assignment are excluded (i.e. censoring at time of this event, if applicable). Week 96 study visit could occur up to 110 weeks following randomization. Censoring time was the latest study visit when participant was evaluated or when NRTI assignment was discontinued (when applicable). Event time was the exact number of weeks following treatment initiation when the qualifying sign/symptom started (for those safety events triggered by a sign/symptom), or exact number of weeks following treatment initiation when specimen from qualifying laboratory result was drawn (for those safety events triggered by a laboratory abnormality).|From treatment dispensation to week 96 study visit|Only randomized participants included. Persons not starting study treatment excluded.|||weeks||95% Confidence Interval|Number
1246096|NCT00537394|Primary|Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment|Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for the discontinuation outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Results report percent of participants reaching regimen failure outcome by week 48 evaluation using Kaplan-Meier method.|From study entry to end of Week 48 evaluation window|Analysis uses intent to treat population, among the two randomized arms only.|||percentage of participants||95% Confidence Interval|Number
1246097|NCT00537381|Secondary|Percent Change From Baseline in ‘Vascular Endothelial Growth Factor (VEGF)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Percent change||Standard Deviation|Mean
1246098|NCT00537381|Secondary|Percent Change From Baseline in ‘N-telopeptide of Type I Collagen (NTx)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Percent change||Standard Deviation|Mean
1246099|NCT00537381|Secondary|Percent Change From Baseline in ‘C-telopeptide of Type I Collagen (CTx)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Percent change||Standard Deviation|Mean
1246100|NCT00537381|Secondary|Overall Survival|Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline until death (up to 887 days)|Efficacy population included all participants randomly assigned to study treatment.|||Days||95% Confidence Interval|Median
1246101|NCT00537381|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later).|Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days|Included all participants randomly assigned to study treatment and had baseline PSA evaluation and at least two post-baseline evaluations that are at least 3 weeks apart.|||Participants|||Number
1246102|NCT00537381|Secondary|Number of Participants With Best Overall Response (OR)|Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to 6 months after last dose of study treatment, assessed up to 551 days|Response evaluable population included participants who had target lesion or non-target lesion at baseline and received at least 1 study treatment and had at least 1 post-baseline response assessment or discontinued study treatment due to disease progression, or death.|||Participants|||Number
1246103|NCT00537381|Primary|Progression-Free Survival (PFS)|The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Baseline up to 6 months after last dose of study treatment, assessed up to 551 days|Efficacy population included all participants randomly assigned to study treatment.|||Days||95% Confidence Interval|Median
1246104|NCT00537329|Secondary|Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups|Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.|EOT (Day 5 up to Day 42)|MITT. May have >1 baseline pathogen; previous surgery=any surgery (includes abdominal surgery) within 1 month prior to baseline (PTB); chemotherapy for solid cell tumors or hematological malignancies at baseline or within 3 months PTB; central venous catheter (CVC) up to 1 month PTB; (n)=subjects per subgroup with analyzable data at observation.|||participants|||Number
1246105|NCT00537329|Secondary|Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT|Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject’s EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT."|||percent change||Standard Deviation|Mean
1246106|NCT00537329|Secondary|Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment|Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject’s at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT."|||pg/mL||Standard Deviation|Mean
1246107|NCT00537329|Secondary|Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment|Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT."|||percent change||Standard Deviation|Mean
1246108|NCT00537329|Secondary|Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment|Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject’s at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT."|||pg/mL||Standard Deviation|Mean
1246109|NCT00537329|Secondary|Time to Death Due to Candidemia|"Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|Baseline through end of 12 weeks after baseline|MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; no subjects died due to candidemia out of the analyzable population.|||days||Full Range|Median
1246110|NCT00537329|Secondary|Time to Death From Any Cause|"Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|Baseline through end of 12 weeks after baseline|MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; < 50% of subjects died out of the analyzable population.|||days||Full Range|Median
1246111|NCT00537329|Secondary|Number of Subjects With Microbiological Response of Success at Endpoints|Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.|EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline|"MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|||participants|||Number
1246112|NCT00537329|Secondary|Number of Subjects With Clinical Response of Success at Endpoints|Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.|EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline|"MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|||participants|||Number
1246113|NCT00537329|Secondary|Number of Subjects With Global Response of Success at Endpoints|Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.|End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline)|"MITT; EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|||participants|||Number
1246114|NCT00537329|Primary|Number of Subjects With Global Response of Success at End of Treatment|Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.|End of treatment (EOT) = Day 5 up to Day 42|Modified Intent to Treat (MITT): includes all Full Analysis Set (FAS) subjects (received at least 1 dose of study treatment) with confirmed, documented diagnosis of candidemia and had received the initial loading dose of study treatment.|||participants|||Number
1246115|NCT00537316|Secondary|Proportion of Participants With Mucosal Healing During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study|Weeks 38, 62 and 94 (Weeks 22, 46 and 78 for direct entry)|||||||
1246116|NCT00537316|Secondary|Proportion of Participants Who Are in Steroid-free Remission During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study.|Weeks 38, 62 & 94 (Weeks 22, 46 and 78 for direct entry)|||||||
1246117|NCT00537316|Secondary|Proportion of Participants With Mucosal Healing at Week 16|Mucosal healing was defined as a Mayo endoscopy score of 0 or 1.|16 weeks|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation).|||Proportion of participants|||Number
1246156|NCT00537056|Secondary|Tumor Necrosis|The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.|12 weeks||||Participants|||Count of Participants
1246118|NCT00537316|Secondary|Proportion of Participants in Response at Weeks 8 and 16|Response at Week 8 is defined as a decrease in the partial Mayo score of ≥1 point. Response at Week 16 is defined as a decrease in total Mayo score of ≥3 points and at least 30% lower than baseline Mayo score. The partial Mayo score consists of the following 3 sub-scores: stool frequency, rectal bleeding, and physician’s global assessment. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician’s global assessment.|Weeks 8 and 16|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-responders) at Week 16.|||Proportion of participants|||Number
1246119|NCT00537316|Primary|Average Remission Rate During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study (Week 38 through Week 94 [Week 22 through Week 78 for direct entry]).|up to Week 94 (Week 78 for direct entry)|||||||
1246120|NCT00537316|Primary|Proportion of Participants in Steroid-free Remission at Week 16|Steroid-free remission is defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point, without the use of corticosteroids. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician’s global assessment.|16 weeks|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-remission) at Week 16.|||Proportion of participants|||Number
1246121|NCT00537303|Secondary|Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide|High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.|||mg/L||Standard Deviation|Mean
1246122|NCT00537303|Secondary|Haematology: Haemoglobin Measured in Blood|Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.|||mmol/L||Standard Deviation|Mean
1246123|NCT00537303|Secondary|Biochemistry: Serum Alanine Aminotransferase|Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.|||U/L||Standard Deviation|Mean
1246124|NCT00537303|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.|||episodes|||Number
1246125|NCT00537303|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the Per Protocol analysis set.|week 36|Per Protocol analysis set: All exposed subjects who completed the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the efficacy results.|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
1246126|NCT00537303|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Analysed for the full analysis set.|week 36|Full analysis set (FAS) is all randomised subjects exposed to at least one dose of trial products.|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
1246127|NCT00537290|Secondary|The Efficacy of Rituximab|Outcome measures scored as complete response(CR),partial(PR),and none(NR) at 24 weeks.For thrombocytopenia,CR defined as a platelet count of ≥150×109/μl,PR as 100–149,and NR as <100.For CVD,CR defined as the disappearance of cardiac lesions,PR as 50%improvement,and NR as no change.For skin ulcer,CR defined as disappearance,PR as 50% improvement,and NR as no change.For aPL nephropathy,CR defined as a normal serum creatinine level,inactive urinary sediment,and urinary protein:creatinine 0.5;PR as a serum cr level 15%above baseline,RBCs per high-power field 50%above baseline with no casts,50%improvement in the urinary prt:cr,and estimated GFR 10%above baseline;and NR as the absence of C/PR.For cognitive dysfunction,CR defined as normalization of the cognitive impairment index with 50%improvement,PR as abnormal index with 50%,and NR as no change.|24 weeks|All patients enrolled in the study|||Participants|||Count of Participants
1246128|NCT00537290|Primary|Number of Participants Experiencing Serious and Non Serious Adverse Events|Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts.|52 weeks + additional 4 months if needed|All patients enrolled in the study.|||Participants|||Count of Participants
1246129|NCT00537277|Secondary|Number of Treatment Emergent Serious Adverse Events (SAEs)|Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.|||events|||Number
1246130|NCT00537277|Secondary|Number of Nocturnal Hypoglycaemic Episodes|Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.|||episodes|||Number
1246131|NCT00537277|Secondary|Number of Diurnal Hypoglycaemic Episodes|Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.|||episodes|||Number
1246132|NCT00537277|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.|||episodes|||Number
1246133|NCT00537277|Secondary|Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%||week 48|Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.|||percentage of trial completers|||Number
1246134|NCT00537277|Primary|Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%||week 48|Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1246135|NCT00537238|Secondary|Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1246136|NCT00537238|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) Score|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study medication and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Least Squares Mean
1246137|NCT00537238|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Least Squares Mean
1246138|NCT00537238|Secondary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up|BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment.|Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Least Squares Mean
1246139|NCT00537238|Secondary|Percentage of Participants Without Seizures|Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.|Baseline up to Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1246140|NCT00537238|Secondary|Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16|Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures.|Baseline, Week 16|SGTC population included all participants who had at least 1 SGTC seizure during either baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of all partial seizure/28days||Standard Deviation|Mean
1246141|NCT00537238|Secondary|Percent Change From Baseline in 28 Day Seizure Frequency at Week 16|The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant’s 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline.|Baseline, Week 16|Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.|||percent change||Full Range|Median
1246142|NCT00537238|Primary|Proportion of Participants With Response to Treatment|Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.|Baseline up to Week 16|Per protocol population included all randomized participants who had at least 28 days of study drug during the maintenance phase and a minimum of 28 days of utilizable seizure diary data during baseline and maintenance phases of the study and had no major protocol violation.|||proportion of participants|||Number
1246143|NCT00537199|Primary|Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone|"Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone.~Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye."|Following two (2) scheduled visits for visual examination, up to one month following first exam|No analysis was performed. Study was terminated by sponsor.||||||
1246144|NCT00537095|Secondary|Time to Death|Interim analysis time to date of randomisation to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.|time from randomisation to date of death|For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo|||participants|||Number
1246145|NCT00537095|Secondary|Objective Response Rate|Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria|46.7 months||||participants|||Number
1246146|NCT00537095|Secondary|Disease Control Rate at 6 Months|number of participants that achieved disease control 6 months after randomisation. Best objective response of complete response + partial response + stable disease > 24 weeks according to RECIST criteria|6 months after randomisation||||participants|||Number
1246147|NCT00537095|Primary|Time to Tumor Progression|modified RECIST V1.0 was used|Time from date of randomisation to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment||||days||95% Confidence Interval|Median
1246148|NCT00537082|Secondary|Annualized Relapse Rate (ARR) at 6 Months|Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.|6 Months|Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS.|||Relapses per year|||Number
1246149|NCT00537082|Secondary|Number of Patients Free of New or Newly Enlarged T2 Lesions|The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion.|up to Month 3 and up to Month 6|Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.|||Participants|||Number
1246150|NCT00537082|Secondary|Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)|A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).|up to Month 6|Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS.|||Participants|||Number
1246151|NCT00537082|Primary|Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6|Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.|Month 3 and Month 6|Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.|||Participants|||Number
1246152|NCT00537056|Secondary|Initial Tumor Size|Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.|pre-sunitinib therapy||||Participants|||Count of Participants
1246153|NCT00537056|Secondary|DCE MRI AUC Peak Flow|Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity).|12 weeks||||Participants|||Count of Participants
1246154|NCT00537056|Secondary|Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan|Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.|12 weeks||||Participants|||Count of Participants
1246155|NCT00537056|Secondary|Tumor Size by Computed Tomography (CT) Scan|Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.|12 weeks||||Participants|||Count of Participants
1246157|NCT00537056|Secondary|Adverse Events|Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced.|up to 12 months||||adverse events|||Number
1246158|NCT00537056|Secondary|Initial Comprehensive Metabolic Panel|A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards.|Prior to baseline DCE MRI||||Participants|||Count of Participants
1246159|NCT00537056|Secondary|Histopathology|Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present.|1 day|Patients with renal cell carcinoma|||Participants|||Count of Participants
1246160|NCT00537056|Primary|F-18 FDG Tumor Uptake (SUV Max)|"The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism.~Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG.~Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response."|12 weeks minus baseline|All patients underwent baseline F-18 FDG PET scan. Mean SUVmax at baseline is reported (row 1). 6 participants achieved progression-free survival after post-sunitinib therapy, and their SUVmax values were averaged (row 2). 11 participants had progression or recurrence/relapse of disease and their SUVmax values were averaged (row 3).|||SUVmax||Standard Deviation|Mean
1246161|NCT00537030|Secondary|Frequency of Asparaginase-related Toxicities Following Erwinase® Treatment.|As assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The incidence of these toxicities will be described. The percentage of patients that have Erwinase® therapy discontinued due to the above toxicities will also be estimated. With a sample size of 50, the incidence of the above toxicities can be estimated with a maximum standard error of 7%.|At each course of Erwinase® treatment|||||||
1246162|NCT00537030|Secondary|Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase|An ELISA (enzyme-linked immunosorbent assay) method will be used to determine the presence of specific anti-Erwinia and anti-PEG-asparaginase antibodies at baseline, and of specific anti-Erwinia asparaginase antibodies after first and subsequent exposures to Erwinase®. The rate of antibody formation will be described and compared informally to experience in CCG-1962 and 1961. Serum asparaginase activity will be compared during Erwinase® courses as an indication of the neutralizing effect of antibodies on the enzyme effect.|At baseline, prior to doses 4, 5, and 6 and on days 15 and 22|||||||
1246163|NCT00537030|Secondary|Determine if Plasma Asparagine is Adequately Depleted|Plasma asparagine depletion will be determined in a subset of 20 patients limited to participating Phase I Institutions.|On days 12 or 13|||||||
1246164|NCT00537030|Primary|Trough Serum Asparaginase Activity|To determine if the 48 hour trough serum asparaginase activity is ≥ 0.1 IU/mL in at least 70% of patients.|Measured in blood at 48 hours post administration of Erwinia asparaginase|Of the 59 enrolled participants, there was 1 ineligible participant and 3 inevaluable participants that were not analyzed leaving a total of 55 participants. Of those 55 participants, 20 participants had an insufficient sample at 48 hours, where a total of 35 participants were analyzed.|||IU/mL of Asparaginase Activity||Full Range|Median
1246165|NCT00537017|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.|Up to 42 weeks|All participants who received treatment with study drug were included in the analysis.|||Participants|||Number
1246166|NCT00537017|Secondary|Total Sleep Time|Participant diaries recorded time spent in the sleep state at half-hourly intervals for at least 3 full days before scheduled visits. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175.|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
1246167|NCT00537017|Secondary|Absolute Duration of Dyskinesias|"Participant diaries recorded time spent in the on state with dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time. Higher values relative to BL signify worsening of dyskinesia (i.e., more time spent with dyskinesia). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
1246251|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||millimole per Liter||Standard Deviation|Least Squares Mean
1246168|NCT00537017|Secondary|"Time Spent in the on State Without Troublesome Dyskinesia"|"Participant diaries recorded time spent in the on state without troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well) concomitant with absence of troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
1246169|NCT00537017|Secondary|"Time Spent in the on State With Troublesome Dyskinesias"|"Participant diaries recorded time spent in the on state with troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well) concomitant with troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
1246170|NCT00537017|Secondary|"Time Spent in the on State With no Dyskinesias"|"Participant diaries recorded time spent in the on state with no dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time. Higher values relative to BL signify an improvement in the Parkinson’s disease symptoms (i.e., participant can move well) concomitant with no dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
1246171|NCT00537017|Secondary|"Awake Time Per Day in the on State"|"Participant diaries recorded time spent in the on state at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Higher on time values relative to BL mean that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
1246172|NCT00537017|Secondary|"Time Spent in Off State Per Day"|"Participant diaires recorded time spent in the off state at half-hourly intervals for at least 3 full days before scheduled visits. “Off” time is defined as when the participant’s medication is not working as subjectively determined by the participant and his/her physician. Higher off time values relative to Baseline (BL) signify that the Parkinson’s disease symptoms are worse (i.e., participant can only move slowly or not at all). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||Hours/day||Standard Deviation|Mean
1246173|NCT00536991|Secondary|Objective Tumor Response, Assessed by RECIST|Judged by monthly physical exam and radiographic evaluation. Patients will be considered evaluable for tumor response if they have at least two post-baseline tumor assessments at least 4 weeks apart, received study medication for 8 weeks or if they have evidence of disease progression. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 11 years|All treated and eligible patients. 26 patients were not evaluable.|||percentage of participants||95% Confidence Interval|Number
1246174|NCT00536991|Secondary|Incidence of Toxicity Graded According to the National Cancer Institute CTC Version 3.0|Count of participants with serious adverse event. Please refer to the adverse event reporting for more detail.|Up to 11 years|All treated and eligible patients|||Participants|||Count of Participants
1246175|NCT00536991|Primary|PSA Response Rate|Patients will be considered evaluable for PSA response if they have at least two post-baseline PSA measurements at least 4 weeks apart, or if they have other evidence of disease progression. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy.|Up to 11 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1246176|NCT00536991|Primary|Determine the Maximum Tolerated Dose (MTD)|Determine the maximum tolerated dose (MTD) of oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole (400 mg thrice daily [TID]) + oral hydrocortisone (20 mg AM, 10 mg PM)|up to 11 years|All Phase I participants|||mcg|||Number
1246177|NCT00536978|Secondary|One-year Disease-free Survival (DFS)|Efficacy (disease-free-survival) defined as number of participants still living, without disease progression following T- cell or Natural killer (NK) cell adback. One-year disease-free survival (DFS) time estimated using the Kaplan-Meier estimator. Patients who experience disease recurrence considered to be a treatment failure event.|1 Year|||||||
1246178|NCT00536978|Primary|6-month Treatment Related Mortality (TRM)|Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.|6 Months|Of the 22 patients enrolled, none received the adback T-Cell or NK cells treatment.|||participants|||Number
1246179|NCT00536913|Secondary|Use of Rescue Medication at Day|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Inhalations||Standard Deviation|Mean
1246180|NCT00536913|Secondary|Use of Rescue Medication at Night|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Inhalations||Standard Deviation|Mean
1246181|NCT00536913|Secondary|Percentage of Nights With Awakenings Due to Asthma|Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Percentage of nights||Standard Deviation|Mean
1246182|NCT00536913|Secondary|Asthma Symptoms at Day|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Daily during run-in and daily during treatment period of 6 weeks||||Units on a scale||Standard Deviation|Mean
1246183|NCT00536913|Secondary|Asthma Symptoms at Night|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Daily during run-in and daily during treatment period of 6 weeks||||Units on a scale||Standard Deviation|Mean
1246184|NCT00536913|Secondary|Evening Peak Expiratory Flow (ePEF)|Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Liters/min||Standard Deviation|Mean
1246185|NCT00536913|Secondary|Morning Peak Expiratory Flow (mPEF)|Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Liters/min||Standard Deviation|Mean
1246186|NCT00536913|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.|At baseline, at 2 weeks and 4 weeks||||Liters||Full Range|Mean
1246187|NCT00536913|Primary|Urinary Free Cortisol (UFC)|Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment|At baseline and 4 weeks||||Ratio||Full Range|Geometric Mean
1246188|NCT00536874|Secondary|Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy|Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy|Baseline and 2 years||||percent change||Full Range|Median
1246189|NCT00536874|Secondary|Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy|Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy|Baseline and 2 years||||percent change||Full Range|Median
1246190|NCT00536874|Secondary|Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy||Baseline and 2 years||||U/ml||Full Range|Median
1246191|NCT00536874|Secondary|RECIST Radiologic Response to Neoadjuvant Therapy|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR|2 years||||participants|||Number
1246192|NCT00536874|Secondary|Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy||Baseline and 2 years||||ng/ml||Full Range|Median
1246193|NCT00536874|Secondary|Overall Survival (Follow-Up Time)||From Baseline until 2 Years and Follow-Up, up to 120 months||||months||Full Range|Median
1246194|NCT00536874|Primary|Overall Survival at 18 Months|Percentage of participants that were alive or survived at 18 months after randomization|18 months||||percentage of participants||95% Confidence Interval|Number
1246195|NCT00536809|Secondary|Change From Baseline to Study Completion in Aspartate Aminotransferase, Alanine Aminotranferease, and Alkaline Phosphatase|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246196|NCT00536809|Secondary|Change From Baseline to Study Completion in Creatinine Clearance|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246252|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV)||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||femtoliter||Standard Deviation|Least Squares Mean
1246197|NCT00536809|Secondary|Change From Baseline to Study Completion in Creatinine, Total Bilirubin, and Direct Bilirubin|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246198|NCT00536809|Secondary|Change From Baseline to Study Completion in Sodium, Potassium, and Calcium|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246199|NCT00536809|Secondary|Change From Baseline to Study Completion in International Normalized Ratio|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246200|NCT00536809|Secondary|Change From Baseline to Study Completion in Prothrombin Time and Partial Thromboplastin Time|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246201|NCT00536809|Secondary|Change From Baseline to Study Completion in White Blood Cells and Platelets|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246202|NCT00536809|Secondary|Change From Baseline to Study Completion in Hemoglobin and Neutrophils|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246203|NCT00536809|Secondary|Change From Baseline to Study Completion in Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246204|NCT00536809|Secondary|Change From Baseline to Study Completion in Heart Rate|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246205|NCT00536809|Secondary|Change From Baseline to Study Completion in Weight|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
1246206|NCT00536809|Secondary|Progression-free Survival (PFS) After Lapatinib, Oxaliplatin, and Capecitabine Administered at the MTD Level of Phase II|Both participants that entered Phase II of the study were censored for progression-free survival. Progression-free survival (PFS) is defined as the time from first dose until the first documented sign of disease progression or death due to any cause. For participants who do not progress or die, PFS was censored at the time of last radiological scan preceding the initiation of alternative anti-cancer therapy. Of the 2 participants in Phase II of the study, one discontinued due to adverse events, and the other was referred for a surgical resection.|Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 135 Days)|All-Treated Population for Phase II||||||
1246207|NCT00536809|Secondary|Genetic Variants in Germline (Host) DNA and Comparison to the Efficacy and Safety of the Study Drugs|This outcome measure was conducted to investigate a possible genetic relationship to handling or response to lapatinib, oxaliplatin, and capecitabine. This measure was not analyzed due to the small number of participants who signed the optional pharmacogenetics consent.|Optional pharmacogenetics sample may be collected at any time during the study after consent has been obtained; however, it is recommended that it be collected at the earliest time point possible|Participants in the All-Treated Population who signed a PGx informed consent.||||||
1246208|NCT00536809|Secondary|Genetic Aberrations in Somatic (Tumor) DNA Derived From the Tumor Tissue Biopsies That May Associate With Clinical Outcomes in Response to Therapy|DNA sequencing was done to identify genetic aberrations in somatic (tumor) DNA that may associate with clinical outcomes in response to therapy. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at end of Cycle 2, +/-3 days from Cycle 3.|All-Treated population for Phase II||||||
1246209|NCT00536809|Secondary|Tumor-derived Biomarkers (Encoded in Protein or RNA) Associated With Clinical Outcome to Treatment|Exploring tumor-derived biomarkers including TS, DPD, TP, EGFR (ErbB1), and additional downstream markers involved in the mechanism of action of each compound (e.g., ERCC1) and comparison to clinical response. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at 43 +/-3 days.|All-Treated population for Phase II||||||
1246210|NCT00536809|Secondary|Effect of Lapatinib, Oxaliplatin, and Capecitabine on Plasma TS mRNA and the Relationship Between Plasma TS mRNA and Clinical Response|A possible association between a reduction in thymidylate synthase (TS) gene expression and increased sensitivity in clinical activity was to be explored. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Blood samples were collected to determine TS levels at screening phase; Days 43 and 85; after every 2 cycles of treatment (+/- 3 days); and at discontinuation (if possible).|All-Treated population for Phase II||||||
1246211|NCT00536809|Secondary|Relationship Between Pretreatment Plasma TS mRNA and Pretreatment Tumor TS mRNA in Colon Tumor Biopsies.|Exploring if there is an association with a reduction in thymidylate synthase (TS) gene expression in both plasma and tumor prior to treatment and increased sensitivity in clinical activity. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Plasma TS mRNA is collected at screening. Pre-treatment tumor sample can be archived tissue if collected within 5 years from screening; if not, tumor sample should be collected at screening.|All-Treated population for Phase II||||||
1246212|NCT00536809|Primary|Overall Response in Phase II|The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study.|Baseline to response (up to 135 days)|All-Treated Population for Phase II: all participants who received at least one dose of lapatinib|||participants|||Number
1246213|NCT00536744|Secondary|Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application||12 weeks post initial application and 24 weeks post initial application|||||||
1246214|NCT00536744|Primary|The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.||12 weeks post initial application|ITT|||participants||95% Confidence Interval|Number
1246215|NCT00536731|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)|Baseline to 6 weeks||||Liters||Standard Deviation|Mean
1246216|NCT00536731|Secondary|Percentage of Rescue Free Days|Change in the Percentage of Rescue Free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Rescue-free Day defined as day and night with no use of rescue medication.|Baseline to 6 weeks||||Percentage of days||Standard Deviation|Mean
1246217|NCT00536731|Secondary|Percentage of Asthma Control Days|Change in the Percentage of Symptom Control Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Asthma Control Day: no symptoms (asthma symptom score=0) night and day, no awakenings due to asthma, no rescue medication.|Baseline to 6 weeks||||Percentage of days||Standard Deviation|Mean
1246218|NCT00536731|Secondary|Percentage of Symptom-free Days|Change in the Percentage of Symptom-free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Symptom-free Day: no symptoms (asthma symptom score=0) night and day, and no awakenings due to asthma.|Baseline to 6 weeks||||Percentage of days||Standard Deviation|Mean
1246219|NCT00536731|Secondary|Use of Rescue Medication, Total|Change in the Use of Rescue Medication (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks||||Inhalations||Standard Deviation|Mean
1246220|NCT00536731|Secondary|Use of Rescue Medication, Day|Change in the Use of Rescue Medication (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks||||Inhalations||Standard Deviation|Mean
1246221|NCT00536731|Secondary|Use of Rescue Medication, Night|Change in the Use of Rescue Medication (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks||||Inhalations||Standard Deviation|Mean
1246222|NCT00536731|Secondary|Percentage of Nights With Awakenings Due to Asthma|"Change in the Percentage of Nights With Awakenings Due to Asthma from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. The participants answered Yes or No whether she/he woke up during the night due to asthma."|Baseline and 6 weeks||||Percentage of night||Standard Deviation|Mean
1246223|NCT00536731|Secondary|Asthma Symptom Score, Total|Change in the Asthma Symptom Score (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks||||Units on a scale||Standard Deviation|Mean
1246224|NCT00536731|Secondary|Asthma Symptom Score, Day|Change in the Asthma Symptom Score (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks||||Units on a scale||Standard Deviation|Mean
1246225|NCT00536731|Secondary|Asthma Symptom Score, Night|Change in the Asthma Symptom Score (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks||||Units on a scale||Standard Deviation|Mean
1246226|NCT00536731|Secondary|Evening Peak Expiratory Flow (PEF)|Change in the Evening PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed|Baseline to 6 weeks||||Liters/min||Standard Deviation|Mean
1246227|NCT00536731|Primary|Morning Peak Expiratory Flow (PEF)|Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed|Baseline to 6 weeks||||Liters/min||Standard Deviation|Mean
1246228|NCT00536575|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The percentage of patients who experience an objective benefit from treatment, determined by the treating physician after reviewing key laboratory values from blood and urine.|24 months||||percentage of participants|||Number
1246229|NCT00536510|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks|Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100|12 weeks|Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1246230|NCT00536510|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks|Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100|12 weeks|Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1246231|NCT00536484|Secondary|Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline|"The urgency severity VAS Scale records the subject’s assessment of the severity of urgency. VAS scale ranges from 1 ‘Very Mild’ to 10 ‘Very Severe’. Negative change indicated improvement.~Change: mean at observation minus mean at baseline."|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).~Number analyzed=participants at Week 12 LOCF"|||scores on a scale||Standard Error|Least Squares Mean
1246232|NCT00536484|Secondary|Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline|"UPS scores range from 0 (I am usually not able to hold urine) to 2 (I am usually able to finish what I am doing before going to the toilet [without leaking]). Improvement: positive score change; No change: score change=0; Deterioration: negative score change"|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.~Number analyzed=participants at Week 12 LOCF."|||percentage of participants|||Number
1246233|NCT00536484|Secondary|Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline|PPBC scale range: 1=’does not cause me any problems at all’ to 6=’causes me many severe problems’. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.~Number analyzed=participants at Week 12 LOCF."|||percentage of participants|||Number
1246234|NCT00536484|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales|"Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement.~Change: mean at Week 12 minus mean at baseline."|Baseline and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline"|||scores on a scale||Standard Error|Least Squares Mean
1246235|NCT00536484|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale|"Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement.~Change: mean at Week 12 minus mean at baseline"|Baseline and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline"|||scores on a scale||Standard Error|Least Squares Mean
1246236|NCT00536484|Secondary|Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline|Change in frequency urgency sum is total urinary sensation scale (USS) ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold:leak urine. Numerical decrease indicates improvement|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).~Number analyzed=participants at Week 12 LOCF."|||scores on a scale||Standard Error|Least Squares Mean
1247019|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea|8 weeks|FAS using imputed values|||Unit on a Scale||Standard Error|Mean
1246237|NCT00536484|Secondary|Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Nocturnal Urgency Episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
1246238|NCT00536484|Secondary|Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline|Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline Nocturnal Micturitions >0 per 24 and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
1246239|NCT00536484|Secondary|Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline|Change in number of UUI episodes (urinary sensation scale [USS] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
1246240|NCT00536484|Secondary|Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of severe urgency episodes (urinary sensation scale [USS] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only those with at least 1 episode during baseline 3-day diary period were included.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
1246241|NCT00536484|Secondary|Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of urgency episodes (urinary sensation scale [USS] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline Urgency Episodes >0 per 24 hours and non missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
1246242|NCT00536484|Secondary|Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline|"The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.~Change: mean at observation minus mean at baseline"|Baseline, Week 2 and Week 6|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2 or Week 6 (last observation carried forward [LOCF]).~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline (n=placebo; n=fesoterodine)"|||number of episodes per 24 hours||Standard Error|Least Squares Mean
1246243|NCT00536484|Primary|Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.|"The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.~Change: mean at Week 12 minus mean at Baseline"|Baseline and Week 12|Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward [LOCF)). The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
1246244|NCT00536471|Secondary|Summary of Adverse Events Leading to Discontinuation||over 9 months|Number of randomized participants in each treatment group.|||participants|||Number
1246245|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint||9 months|Number of participants with a normal baseline and at least one post-baseline measurement.|||participants|||Number
1246246|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months||over 9 months|Number of participants with a normal baseline at at least one post-baseline measurement.|||participants|||Number
1246247|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint|The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.|over 3 months|Number of participants with a normal baseline and at least one post-baseline measurement.|||participants|||Number
1246248|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin||Baseline, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||millimoles per Liter (iron)||Standard Deviation|Least Squares Mean
1246249|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase||baseline, 9 months|Number of participants with non-missing data at baseline and at least one post baseline visit.|||Units per Liter||Standard Deviation|Least Squares Mean
1246250|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least post-baseline visit.|||Billions per Liter||Standard Deviation|Least Squares Mean
1246253|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||Proportion of 1.0||Standard Deviation|Least Squares Mean
1246254|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||micromole per Liter||Standard Deviation|Least Squares Mean
1246255|NCT00536471|Secondary|Abnormal Vital Signs at 9 Month Endpoint||9 months|Number of participants with a normal baseline and at least one post-baseline measurement.|||participants|||Number
1246256|NCT00536471|Secondary|Abnormal Vital Signs at 12 Week Endpoint||12 weeks|Number of participants with a normal baseline and at least one post-baseline measurement.|||participants|||Number
1246257|NCT00536471|Secondary|Abnormal Vital Signs at Anytime Over 9 Months||over 9 months|Number of participants with a normal baseline and at least oone post-baseline measurement.|||participants|||Number
1246258|NCT00536471|Secondary|Abnormal Vital Signs at Anytime Over 12 Weeks||over 12 weeks|Number of participants wtih a normal baseline and at least one post-baseline measurement.|||participants|||Number
1246259|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Weight||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||kilograms||Standard Error|Least Squares Mean
1246260|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||beats per minute||Standard Error|Least Squares Mean
1246261|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure|Sitting systolic and diastolic blood pressure.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||mm Hg||Standard Error|Least Squares Mean
1246262|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score|A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246263|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)|A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246264|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246265|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)|Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Deviation|Least Squares Mean
1246266|NCT00536471|Secondary|Probability of Response at 12 Week Endpoint|Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.|||probability of response||Standard Error|Least Squares Mean
1246267|NCT00536471|Secondary|Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint|Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||probability of remission||Standard Error|Least Squares Mean
1246268|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score|A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Deviation|Least Squares Mean
1246269|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect|For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.|Over 12 weeks||||percent of total effect|||Number
1246270|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score|Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis.|over 12 weeks||||coefficient|||Number
1246272|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7|Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis.|Over 12 weeks||||coefficient|||Number
1246273|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246274|NCT00536471|Secondary|Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.|Baseline, 12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246275|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment)|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246276|NCT00536471|Secondary|Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment).|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).|Baseline, 12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246277|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness|Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246278|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness|Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246279|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness|Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246280|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms|Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246281|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms|Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246282|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization|Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246283|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity|Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246284|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation|Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246285|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight|Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246286|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight|Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246287|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis|Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246288|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms|Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246289|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General|Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246290|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal|Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246291|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)|Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246292|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)|Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246293|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation|Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246294|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation|Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246295|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities|Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246296|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late|Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246297|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle|Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246298|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early|Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246299|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide|Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).|Baseline, 12 weeks, 9 Months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246300|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt|Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246301|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood|Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246302|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246303|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores.|Baseline, 8 weeks, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246304|NCT00536471|Primary|Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)|Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).|baseline, 8 weeks|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1246342|NCT00535938|Secondary|Concurrent Surgical Procedure Resource Utilization Patterns|Resource utilization patterns are assessed in terms of concurrent surgical procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)|Up to 1,785 days|Enrolled Cohort: All patients enrolled in the study|||Patients|||Number
1246305|NCT00536380|Primary|Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg|The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was “reflective”, covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period.|Baseline and 4 treatment weeks|Intent to treat population|||Units on a scale||Standard Error|Least Squares Mean
1246306|NCT00536341|Secondary|Overall Survival|Defined as the time from Day 1 of treatment administration to date of death from any cause, estimated using Kaplan-Meier methods.|Every 3 months until treatment discontinuation, expected average of 6 months and then every 6 months thereafter up to 5 years|All treated patients, all dose levels|||months||95% Confidence Interval|Median
1246307|NCT00536341|Secondary|Progression-Free Survival|Measured from first treatment to disease progression and assessed using Kaplan-Meier methods.|Every 3 months during treatment until disease progression and every 6 months thereafter, up to 5 years|All treated patients, all dose levels|||months||95% Confidence Interval|Median
1246308|NCT00536341|Primary|Complete Response Rate|An improvement in complete response to at least 60% following treatment, assessed using CT scans, clinical/lab examinations, and bone marrow aspirations, as defined by National Cancer Institute Working Group Response Criteria.|At 12 weeks during treatment and 2 months post-treatment until disease progression, projected 8 months|All patients deemed evaluable and evaluated for response|||participants|||Number
1246309|NCT00536341|Primary|Number of Adverse Events as a Measure of Safety and Tolerability|Recorded from first treatment until 30 days after last treatment and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|63 months|All treated patients|||participants|||Number
1246310|NCT00536263|Secondary|Change From Baseline in Liver Biopsy Score|"Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System):~Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis).~Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]).~Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of~inflammatory cells in >2/3 of portal tracts]).~Score IV (fibrosis): 0 (none) to 4 (cirrhosis)."|Baseline to 24 weeks after end of treatment|Treated participants from designated sites|||Units on a scale||Standard Deviation|Mean
1246311|NCT00536263|Secondary|Hepatitis B Surface Antigen (HBs) Seroconversion|HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
1246312|NCT00536263|Secondary|Hepatitis B Surface Antigen (HBsAg) Loss|HBsAg Loss was tested by assay of Abbott MEIA|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
1246313|NCT00536263|Secondary|Number of Participants With Combined Response|Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
1246314|NCT00536263|Secondary|Number of Participants With Biochemical Response|Biochemical response was defined as alanine aminotransferase (ALT) normalization.|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
1246315|NCT00536263|Secondary|Number of Participants With HBV-DNA Undetectable|Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR).|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
1246316|NCT00536263|Secondary|Number of Participants With HBV-DNA < 200 IU/mL|HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
1246317|NCT00536263|Secondary|Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL|"HBV-DNA was tested by assay of Roche Cobas Taqman (the test~lowest limit is 6 IU/mL)"|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
1246318|NCT00536263|Secondary|HBe Seroconversion|HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
1246319|NCT00536263|Secondary|Number of Participants With HBeAg Loss|HBeAg Loss was tested by assay of Abbott MEIA|Up to Treatment Week 48|Treated participants|||Participants|||Number
1246320|NCT00536263|Primary|Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss|HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)|24 weeks after end of treatment (EOT)|Treated participants|||Participants|||Number
1246321|NCT00536198|Secondary|Clinical Global Impressions-Improvement (CGI-I)|The Clinical Global Impressions-Improvement (CGI-I) scale is a 7-point scale with 7 being the least improvement.|Cycle 1 to Cycle 6|all participants who were measured at a visit past baseline were analyzed|||units on a scale||Standard Deviation|Mean
1246322|NCT00536198|Secondary|DRSP Anger/Irritability Subscale|Anger/irritability included anger/irritability and conflicts with people. Symptoms were scored on a scale 1-6. The range is 0 to 12 with a higher score indicating greater symptom severity.|Baseline to Cycle 6||||units on a scale||Standard Deviation|Mean
1246323|NCT00536198|Secondary|DRSP Physical Subscale|Physical symptoms included breast tenderness, bloating, headache, joint or muscle pain. Symptoms were scored on a scale of 1-6. The severity range is 0-24 with 24 being more symptomatic.|Baseline to Cycle 6||||units on a scale||Standard Deviation|Mean
1246324|NCT00536198|Secondary|DRSP Depression Subscale|Depressive symptoms included: felt depressed, felt hopeless, felt worthless or guilt, slept more, trouble sleeping, felt overwhelmed. Symptoms were scored on a scale of 1-6 The score range is 0-36 with higher indicating greater severity.|Baseline to Cycle 6||||units on a scale||Standard Deviation|Mean
1246343|NCT00535938|Secondary|Concurrent Procedure Resource Utilization Patterns|Resource utilization patterns are assessed in terms of concurrent procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)|Up to 1,785 days|Enrolled Cohort: All patients enrolled in the study|||Patients|||Number
1246325|NCT00536198|Primary|DRSP|DRSP (Daily Rating of Severity Problems) is composed of 21 items reflecting the 11 candidate symptoms for PMDD according to DSM IV and DSM V. Each symptom is scored 1-6. A diagnosis of PMDD requires a minimum average luteal phase score of greater than or equal to 3 (mild) for at least 5 PMDD symptoms during the five most symptomatic of the final seven luteal phase days and the first two days of menses onset, and we require that the average follicular phase score not be >2 on these same items. The minimum score is 0 and maximum is 126 for the total score. A higher score indicates greater severity of symptoms.|Baseline to Cycle 6||||units on a scale||Standard Deviation|Mean
1246326|NCT00536198|Primary|Number of Symptomatic Days Before Pills Were Taken|"Symptomatic days were those that participant experienced at least 3 symptoms at a severity of at least 3, which is a mean of at least mild."|Cycle 1 to Cycle 6|all enrolled participants were analyzed|||days||Standard Deviation|Mean
1246327|NCT00536198|Primary|Number of Days Pills Were Taken|The number of days that pills were taken on.|Measured from Cycle 1 to Cycle 6|all participants enrolled were analyzed|||number of days||Standard Deviation|Mean
1246328|NCT00536198|Other Pre-specified|Adverse Events|A measurement of frequency of adverse events by random assignment|Baseline through Cycle 6|all enrolled participants were analyzed|||participants|||Number
1246329|NCT00536198|Secondary|Clinical Global Severity (CGI-S)|Clinical Global Impressions-Severity is measured on a scale of 1-7, with 7 as most severe.|Baseline through Cycle 6|all participants enrolled analyzed|||units on a scale||Standard Deviation|Mean
1246330|NCT00536198|Primary|Michelson SSRI Withdrawal Checklist|Michelson SSRI Withdrawal Checklist - 16-item (not exactly 17-item, mood swings and crying were in DRSP) including dizziness, nausea, unusual dreams, chills, increased sweating, loose stools, agitation, ringing or noises in the ears. Items were summed for 3 days after pill-taking ended for each menstrual cycle.Scale is 0-80 for total range of the scale with lower less severe. There are no units|Measured from Cycle 1 to Cycle 6|all participants enrolled were analyzed|||units on a scale||Standard Deviation|Mean
1246331|NCT00536198|Primary|Inventory of Depression Symptoms (IDS-C)|Inventory of Depressive Symptomatology-Clinician version (IDS-C) - a depression measure that has 28 items and detects appropriate variations between follicular and luteal phases in subjects with PMDD. Min score is 0, max is 84.Lower score is less symptomatic.|Measured from baseline to Cycle 6|all participants enrolled were analyzed|||units on a scale||Standard Deviation|Mean
1246332|NCT00536198|Primary|Premenstrual Tension Scale (PMTS)|The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems|Measured from baseline to Cycle 6|all randomized participants|||units on a scale||Standard Deviation|Mean
1246333|NCT00536172|Primary|Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)|Number of participants reaching pre-defined threshold on the QIDS-SR-16 of >/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression.|Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28|Evaluable subjects|||participants|||Number
1246334|NCT00536120|Secondary|Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6|Alpha4-integrin expression is the mean fluorescent intensity (MFI), a measure of fluorescence intensity often used to monitor changes in surface antigen modulation in flow cytometry. There is no reference range for this test, which was developed at Biogen Idec.|Month 0 (Baseline), Month 3, and Month 6|Participants who had received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.|||mean fluorescent intensity (MFI)||Standard Deviation|Mean
1246335|NCT00536120|Secondary|Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6|Measurement of the degree of natalizumab saturation of the alpha4 integrin on peripheral blood mononuclear cells was accomplished by staining cells with phycoerythrin conjugated anti human IgG4 antibody (hIgG4-PE) to label the cell-bound natalizumab, followed by flow cytometric detection and quantification.|Month 0 (Baseline), Month 3, and Month 6|Participants who received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.|||percent saturation||Standard Deviation|Mean
1246336|NCT00536120|Secondary|Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy|The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).|Month 0 (Baseline), Month 6|Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.|||percent change||Standard Deviation|Mean
1246337|NCT00536120|Secondary|Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy|The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).|Month 0 (Baseline), Month 3|Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.|||percent change||Standard Deviation|Mean
1246338|NCT00536120|Primary|Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination|Tetanus responders were defined as participants who had at least a 2-fold increase over pre-immunization levels of anti-tetanus antibodies in their blood at 28 days after they were immunized with tetanus.|28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)|Participants with an assessment at Day 28 and a pre-immunization antibody value ≤ 3.5 IU/mL. No imputation methods were used in the primary analyses.|||percentage of participants|||Number
1246339|NCT00536120|Primary|Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination|KLH responders were defined as those participants who had at least a 2-fold increase over pre-immunization level of anti-KLH antibodies in their blood at 28 days after vaccination with KLH.|28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)|Participants with an assessment at Day 28. No imputation methods were used in the primary analyses.|||percentage of participants|||Number
1246344|NCT00535938|Secondary|"BOTOX® Dose in Patients With Other Disorders"|"Other disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 568 days for patients with other disorders."|Baseline, SV1 (up to 568 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
1246345|NCT00535938|Secondary|BOTOX® Dose in Patients With Facial Nerve Disorder|Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 765 days for patients with facial nerve disorder.|Baseline, SV1 (up to 765 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
1246346|NCT00535938|Secondary|BOTOX® Dose in Patients With Cerebral Palsy|Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 925 days for patients with cerebral palsy.|Baseline, SV1 (up to 925 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
1246347|NCT00535938|Secondary|BOTOX® Dose in Patients With Adult Focal Spasticity|Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,562 days for patients with adult focal spasticity.|Baseline, SV1 (up to 1,562 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
1246348|NCT00535938|Secondary|BOTOX® Dose in Patients With Hyperhidrosis|Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,273 days for patients with hyperhidrosis.|Baseline, SV1 (up to 1,273 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
1246349|NCT00535938|Secondary|BOTOX® Dose in Patients With Blepharospasm|Blepharospasm is a condition in which the eyelids blink/close involuntarily. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 542 days for patients with blepharospasm.|Baseline, SV1 (up to 542 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
1246350|NCT00535938|Secondary|BOTOX® Dose in Patients With Cervical Dystonia|Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 505 days for patients with cervical dystonia.|Baseline, SV1 (up to 505 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
1246351|NCT00535938|Primary|"Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders"|"Other disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The SF-12 is 12 questions on various health questions. Health utility is a numerical indicator of a person’s preference for a given health state or health outcome. Health utility is a sub-score ranging from 0(death) to 1(perfect health) calculated from the SF-12 total score based on: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and SV1 is scheduled at the physician’s discretion and was a maximum of 568 days for patients with other disorders."|Baseline, SV1 (up to 568 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
1246352|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder|Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 765 days for patients with facial nerve disorder.|Baseline, SV1 (up to 765 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
1246353|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity|Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,562 days for patients with adult focal spasticity.|Baseline, SV1 (up to 1,562 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
1246354|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy|Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 925 days for patients with cerebral palsy.|Baseline, SV1 (up to 925 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
1246355|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis|Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,273 days for patients with hyperhidrosis.|Baseline, SV1 (up to 1,273 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
1246356|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm|Blepharospasm is a condition in which the eyelids blink/close involuntarily. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 542 days for patients with blepharospasm.|Baseline, SV1 (up to 542 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
1246357|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia|Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 505 days for patients with cervical dystonia.|Baseline, SV1 (up to 505 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
1246358|NCT00535873|Primary|Overall Response Rate (ORR)|ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes >1500/µL, platelets >100,000/µL, hemoglobin >11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets >100,000/µL or 50% improvement ; Hemoglobin >11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.|From 3 cycles (90 days) up to 6 cycles (approximately 180 days)||||participants|||Number
1246359|NCT00535847|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline through Week 48|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).|||participants|||Number
1246360|NCT00535847|Secondary|Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response|Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.|Baseline up to Week 72|The FA set included subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]). Data was presented for overall subjects based on eRVR and SVR status as per planned analysis.|||participants|||Number
1246361|NCT00535847|Secondary|Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|48 weeks after completion of treatment (up to Week 96)|Analysis population included subjects who completed assigned treatment in this study (VX06-950-107 [NCT00535847]).|||percentage of participants||95% Confidence Interval|Number
1246362|NCT00535847|Secondary|Percentage of Subjects With End of Treatment Response|Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|End of treatment (up to Week 48)|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).|||percentage of participants||95% Confidence Interval|Number
1246363|NCT00535847|Secondary|Percentage of Prior Relapsers With Undetectable HCV RNA|Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of treatment (up to Week 72)|Analysis population included all enrolled subjects who were prior relapsers in parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) and received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).|||percentage of participants||95% Confidence Interval|Number
1246364|NCT00535847|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of treatment (up to Week 72)|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).|||percentage of participants||95% Confidence Interval|Number
1246365|NCT00535821|Primary|Mortality|In-hospital mortality|hospital||||participants|||Number
1246366|NCT00535782|Primary|Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)|Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.|Baseline and Week 12|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.|||meters/second||Standard Deviation|Mean
1246367|NCT00535782|Secondary|Number of Participants Experiencing Adverse Events (AEs)|"A severe AE is an event in which the intensity of the event results in an inability to work or perform normal daily activity.~A Serious AE is fatal, life-threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one of the above outcomes.~AEs of special interest include infection, gastrointestinal, infusion reaction (occurring during or within 24 hours of infusion), hepatic disorder, myocardial infarction and stroke."|Up to Week 24|The safety population includes all patients who received any part of an infusion of study drug and who provided at least one assessment of safety. Randomized patients who received the incorrect therapy from that intended are summarized in the group according to the therapy actually received.|||participants|||Number
1246379|NCT00535730|Secondary|Safety and Tolerability of Both Vaccines When Administered Concomitantly.|All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events.|Eight weeks postvaccination|All subjects who received at least one vaccination|||Participants|||Number
1246368|NCT00535782|Secondary|Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)|Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid–femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.|Baseline and Week 24|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.|||meters/second||Standard Deviation|Mean
1246369|NCT00535782|Secondary|Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers|Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.|Baseline and Week 24|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.|||nmol/L||Standard Deviation|Mean
1246370|NCT00535782|Primary|Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers|Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.|Baseline and Week 12|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.|||nmol/L||Standard Deviation|Mean
1246371|NCT00535769|Secondary|Recalled Frequency of Sunscreen Application|The participants were asked to recall their frequency of sunscreen application based on a 5 point scale (0 never used sunscreen,; 1 forgot to apply 3x weekly,; 2 forgot to apply 1-2x weekly; 3 forgot to apply 1-2x per month; 4 always remembered)|6 weeks|All participants were assessed|||units on a scale||Standard Deviation|Mean
1246372|NCT00535769|Secondary|Usefulness of Text Messaging System|Patients with the text message reminder system were asked their opinion on their satisfaction/ improved adherence to sunscreen application with the use of the messaging system on a scale of 0 to 10 (0, not useful at all; 10,most useful)|6 weeks|Patients with text messaging system included in analysis|||units on a scale||Standard Deviation|Mean
1246373|NCT00535769|Primary|Number of Days the Subjects Are Adherent to Using Sunscreen|Participants’ adherence was captured in real time using transmitting electronic monitors. At the end of the 6 week trial, the mean number of days the subjects are adherent to using sunscreen were compared.|6 weeks|All participants were analyzed|||days||95% Confidence Interval|Mean
1246374|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.|||micrograms/mL||95% Confidence Interval|Geometric Mean
1246375|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.|||micrograms/mL||95% Confidence Interval|Geometric Mean
1246376|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.|||micrograms/mL||95% Confidence Interval|Geometric Mean
1246377|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.|||micrograms/mL||95% Confidence Interval|Geometric Mean
1246378|NCT00535730|Primary|Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.|"GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23.~gpELISA = glycoprotein enzyme-linked immunosorbent assay."|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1246380|NCT00535730|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|"GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.~*gpELISA = glycoprotein enzyme-linked immunosorbent assay"|4 weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.|||gpELISA units*/mL||95% Confidence Interval|Geometric Mean
1246381|NCT00535652|Primary|Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue|The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours|The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours||||mg/kg||Standard Deviation|Mean
1246382|NCT00535652|Secondary|Safety Assessment||0 to approx. 14 days after admission|||||||
1246383|NCT00535652|Primary|Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..||3 to 6 hours after a single dose of 1 gram ertapenem I.V..|||||||
1246384|NCT00535626|Secondary|Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative|The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-op, 3 month, 1, 2, 3, 4, 5 years|Participants/hips with available data. Overall number of participants and hips analysed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
1246385|NCT00535626|Secondary|Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction|Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks.|3 month, 1, 2, 3, 4, 5 years|Participants/hips are based on evaluable films for this data point. Overall number of participants and hips is based upon the 3 month population.|||hips|hips||Count of Units
1246386|NCT00535626|Secondary|Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones|Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones.|3 month, 1, 2, 3, 4, 5 years|Participants/hips are based on evaluable films for this data point. Overall number of participants and hips analyzed is based upon the 3 month population.|||hips|hips||Count of Units
1246387|NCT00535626|Secondary|Change in SF-36 From Pre-operative to Post-operative Visits|The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-op, 3 month, 1, 2, 3, 4, 5 years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
1246388|NCT00535626|Secondary|Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits|The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.|pre-op, 3 month, 1, 2, 3, 4, 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
1246389|NCT00535626|Primary|Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation||5 years post-operative|No cases were pending revision.|||hips|hips||Count of Units
1246390|NCT00535587|Secondary|Improvement of Fibromyalgia Symptoms||6 months|||||||
1246391|NCT00535587|Primary|Levels of Growth Hormone Post Exercise|Serum growth hormone at peak V02/treadmill|6 months|ITT|||ng/ml||Standard Deviation|Mean
1246392|NCT00535496|Primary|Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex|The difference between the recovery of T4/T1 ratio to 0.9 and reappearance of T4 within participants was assessed from an ANOVA method. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31; and the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 3 minutes after administering sugammadex|The ITT population: all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias; their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed. The 1.0 mg/kg group was not evaluated.|||Minutes||95% Confidence Interval|Mean
1246393|NCT00535496|Primary|Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)|Neuromuscular function was monitored with a PNS by applying repetitive TOF stimulation to the ulnar nerve of one forearm every 15 seconds and assessing the number of twitches at the adductor pollicis muscle by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 4.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|up to 2 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 1.0 mg/kg were not evaluated for this outcome measure.|||Minutes||Standard Deviation|Mean
1246834|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment|Other skin lesions included presence or absence of xerosis and paronychia.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||percentage of participants|||Number
1246394|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.7 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 42 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.|||Minutes||Standard Deviation|Mean
1246395|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.8 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 42 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.|||Minutes||Standard Deviation|Mean
1246396|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 mg/kg Sugammadex to Reappearance of T4 Measured by a PNS|Neuromuscular function was monitored by applying repetitive TOF stimulations manually to the ulnar nerve of one forearm every 15 seconds & the number of twitches collected manually at the adductor pollicis muscle with the PNS by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 1.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 5 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 4.0 mg/kg were not evaluated for this outcome measure.|||Minutes||Standard Deviation|Mean
1246397|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T4 is the fourth twitch after TOF nerve stimulation. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 7 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.|||Minutes||Standard Deviation|Mean
1246398|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 1.0 mg/kg sugammadex are presented where the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 150 minutes after administering sugammadex|The ITT population: randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant was not analyzed as the time of recovery was judged unreliable. The 4.0 mg/kg group was not evaluated.|||Minutes||Standard Deviation|Mean
1246399|NCT00535496|Primary|Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 4 minutes after administering sugammadex|The Intent-To-Treat (ITT) population: randomized, received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed.The 1.0 mg/kg group was not evaluated.|||Minutes||Standard Deviation|Mean
1247020|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Percent of FEV1 over FVC||Standard Error|Mean
1246400|NCT00535405|Secondary|Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12|Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.|12 Weeks|Patients with AVD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
1246401|NCT00535405|Secondary|Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12|Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.|12 Weeks|Patients with High Risk for CHD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
1246402|NCT00535405|Secondary|Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12||12 Weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
1246403|NCT00535405|Secondary|Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12|Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.|12 Weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
1246404|NCT00535405|Secondary|Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12||12 weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
1246405|NCT00535405|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12||Baseline and 12 weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent change in LDL-C||95% Confidence Interval|Least Squares Mean
1246406|NCT00535392|Secondary|Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.|||Consecutive doses||Standard Deviation|Mean
1246407|NCT00535392|Secondary|Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.|||Subjects|||Number
1246408|NCT00535392|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.|||Subjects|||Number
1246409|NCT00535301|Secondary|Vaginal Mesh Exposure|Vaginal mesh exposure defined as appearance of mesh, placed during the index surgery, not covered by overlying vaginal epithelium on postoperative pelvic exams subsequent to the first postoperative exam. May be either symptomatic or asymptomatic. This was not differentiated in the statistical analysis.|perioperative||||participants|||Number
1246410|NCT00535301|Secondary|Operative Time|Calculated as time from first incision to time of closure of last incision.|perioperative||||minutes||Inter-Quartile Range|Median
1246411|NCT00535301|Primary|Recurrent Stage II or Greater Anterior Vaginal Prolapse|Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is –3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.|three years|Intention to Treat. Stage II or greater anterior vaginal prolapse was defined as POPQ Ba equal to or greater than -1.|||participants|||Number
1246412|NCT00535288|Secondary|Change From Baseline in WHQ Vasomotor Symptoms Domain Score at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants who received study drug and had valid answers recorded for the WHQ domain for vasomotor symptoms.|||Score on a scale||Standard Deviation|Mean
1246413|NCT00535288|Secondary|Change From Baseline in Women's Health Questionnaire (WHQ) Sleep Problems Symptoms Domain Score at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Sleep problems encompass Items 1, 11, and 29 of the 36 total items. The transformed sums of items 1, 11, and 29 were divided by 3 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants who received study drug and had valid answers recorded for the WHQ domain for sleep problems.|||Score on a scale||Standard Deviation|Mean
1246414|NCT00535288|Secondary|Total Number of Remitters by Week|A participant was defined as a (hot flush) remitter for a study week if at most one moderate/severe vasomotor symptom per day on average was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-remitter.|Up to 12 weeks|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week. An LOCF approach was used.|||Participants|||Number
1246415|NCT00535288|Secondary|Total Number of Responders by Week|A participant was defined as a (hot flush) responder for a study week if a reduction of at least 50% for average daily frequency of moderate/severe vasomotor symptoms (hot flushes) (Frequency Score A) compared to Baseline was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-responder. An LOCF approach was used.|Up to 12 weeks|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Participants|||Number
1246416|NCT00535288|Secondary|Change From Baseline in Average Daily Mild to Severe Composite Symptoms Score (Composite Score B) by Week|Composite Score B was calculated as Severity Score B x Frequency Score B.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Composite score||Standard Deviation|Mean
1246417|NCT00535288|Secondary|Change From Baseline in Average Daily Severity of Mild to Severe Vasomotor Symptoms (Severity Score B) by Week|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score B was calculated as the number of mild hot flushes + the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of all hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Severity score||Standard Deviation|Mean
1246418|NCT00535288|Secondary|Change From Baseline in Average Daily Frequency of Mild to Severe Vasomotor Symptoms (Frequency Score B) by Week|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score B was based on the number of mild hot flushes + the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Events per day||Standard Deviation|Mean
1246419|NCT00535288|Secondary|Change From Baseline in Average Daily Moderate/Severe Composite Score (Composite Score A) by Week|Composite Score A was calculated as Severity Score A x Frequency Score A.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Composite score||Standard Deviation|Mean
1246420|NCT00535288|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Severity score||Standard Deviation|Mean
1246421|NCT00535288|Secondary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) by Week Excluding Weeks 4 and 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Severity score||Standard Deviation|Mean
1247021|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Percent of FEV1 over FVC||Standard Error|Mean
1246422|NCT00535288|Secondary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) by Week Excluding Weeks 4 and 12|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Events per day||Standard Deviation|Mean
1246423|NCT00535288|Primary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 12|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Events per day||Standard Deviation|Mean
1246424|NCT00535288|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Severity score||Standard Deviation|Mean
1246425|NCT00535288|Primary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 4|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The Intent-to-Treat (ITT) population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Events per day||Standard Deviation|Mean
1246426|NCT00535262|Primary|Reduction of Depression CGI Score (<= 2)|"HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire~0 participants analyzed due to early termination of study."|8 weeks|||||||
1246427|NCT00535223|Secondary|Posttraumatic Cognitions Inventory (PTCI)|This 36 item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. Each item is rated between 1 ( Totally Disagree) to 7 ( Totally Agree). The best score would be 36, indicating that the participant totally did not agree with any of the thoughts that have been associated with PTSD. The worse score would be 252, which would indicate that the participant totally agreed with all of the cognitions that have been associated with PTSD|Pre-treatment, Post-Treatment (16 weeks) and One year Post Treatment||||units on a scale||Standard Deviation|Mean
1246428|NCT00535223|Primary|Clinician Administered PTSD Scale (CAPS)|This is an interview regarding the frequency and intensity of each of the 17 PTSD symptoms found in DSM IV and includes information about the degree to which these symptoms are interfering with functioning. This interview includes that clinician rating the participants responses for both the frequency of each symptom and the intensity of each symptom on a scale of zero to four. A score of 0, best possible score, would indicate that the participant is no longer reporting any of the 17 DSM IV symptoms of PTSD. The worse possible score is 136, this would indicate that a participant was reporting every symptoms of PTSD occurring daily or almost daily and that each symptom is causing the most extreme level of distress.|Pre treatment, Post treatment (16 weeks) and One year post treatment|Pre-tx Post-tx 1-yr F.U. N M SD Range N M SD Range N M SD Range GBET 41 82.44 15.09 55-107 41 71.73 20.55 34-105 35 69.29 20.71 24-107 PCGT 40 81.18 14.31 52-109 40 75.43 23.01 18-122 33 71.03 22.80 37-121|||units on a scale||Standard Deviation|Mean
1246429|NCT00535145|Primary|The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER|Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.|Day 1 - Day 62|Safety Analysis Set|||Participants|||Number
1246459|NCT00534937|Secondary|Change in Wound Surface Area for Non Healed Subject at 12 Weeks.|Change in wound surface area in cm2 from the initial screening to week 12 for all subject who did not completely healed before or at the 12 week visit.|12 weeks|The participants are those that didn't achieve complete wound healing after 12 weeks of treatment. The change from screening to week 12 in wound surface area is reported.|||cm2||Standard Deviation|Mean
1246430|NCT00535145|Secondary|Personal and Social Performance Score (PSP) Change From Baseline|The PSP (range 1-100) is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Day 1 - Day 62|Includes participants in the efficacy analysis set for with PSP scores available.|||Scores on a scale||Standard Deviation|Mean
1246431|NCT00535145|Secondary|Clinical Global Impression of Severity (CGI-S) Change From Baseline|The CGI-S (range 1-7) is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness.|Day 1 - Day 62|Efficacy Analysis Set|||Scores on a scale||Standard Deviation|Mean
1246432|NCT00535145|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline|"The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale (1=Absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate/Severe, 6=Severe, 7=Extreme).The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia."|Day 1 - Day 62|Efficacy Analysis Set|||Scores on a scale||Standard Deviation|Mean
1246433|NCT00535132|Secondary|Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint|The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246434|NCT00535132|Secondary|Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint|The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246435|NCT00535132|Secondary|Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint|The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Scores on a scale||Standard Deviation|Mean
1246436|NCT00535132|Secondary|Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint|The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Scores on a scale||Standard Deviation|Mean
1246437|NCT00535132|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint|The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states “taking all things into account, how satisfied or dissatisfied are you with this medication?” and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246438|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Participants|||Number
1246439|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 6|Intent-to-Treat Population with non-missing values at this timepoint|||Participants|||Number
1246460|NCT00534937|Primary|Complete Healing Rate of Venous Stasis Ulcers|Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.|12 weeks||||participants|||Number
1246440|NCT00535132|Other Pre-specified|Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Worst value is 7 and best value is 1."|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246441|NCT00535132|Other Pre-specified|Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint|The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246442|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 4|Intent-to-Treat Population with non-missing values at this timepoint|||Participants|||Number
1246443|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 2|Intent-to-Treat Population with non-missing values at this timepoint|||Participants|||Number
1246444|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 6|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246445|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 4|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246446|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 2|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246447|NCT00535132|Primary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
1246448|NCT00535002|Primary|Cocaine Craving|"Cocaine-dependent participants were pre-treated with either yohimbine or placebo provided subjective ratings of cocaine craving immediately following cocaine cue exposure.~The scale used was the Within Sessions Ratings Scales (Childress AR, McLellan AT, O'Brien CP (1986) Conditioned responses in a methadone population. A comparison of laboratory, clinic, and natural settings. Journal of Substance Abuse Treatment 3:173-179.) Craving was rated on a scale of 0-10 with 0 being Not At All and 10 being Extremely."|Post cocaine cue exposure||||units on a scale||Standard Deviation|Mean
1246449|NCT00534976|Secondary|Number of Participants Requiring Rescue Medication at 24 Hours Postdose|This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication.|0-90 minutes after the exercise challenge at 24 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||Participants|||Number
1246450|NCT00534976|Secondary|Number of Participants Requiring Rescue Medication at 2 Hours Postdose|This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication.|0-90 minutes after the exercise challenge at 2 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||participants|||Number
1246511|NCT00534404|Secondary|Self-reported 30-day Prolonged Abstinence at 3-month Follow up||3-months post randomization||||participants|||Number
1246512|NCT00534404|Secondary|Self-reported 30-day Prolonged Abstinence at 9-month Follow up||9 months post randomization||||participants|||Number
1246451|NCT00534976|Secondary|Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose|This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45 & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication.|0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||Minutes||Standard Deviation|Mean
1246452|NCT00534976|Secondary|Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose|"This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time.~Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins.~The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication."|0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||Minutes||Standard Deviation|Mean
1246453|NCT00534976|Secondary|Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose|AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.|Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||percent fall * minute||Standard Deviation|Mean
1246454|NCT00534976|Secondary|Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose|AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.|Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||percent fall * minute||Standard Deviation|Mean
1246455|NCT00534976|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose|Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.|Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||percent fall in FEV1||Standard Deviation|Mean
1246456|NCT00534976|Primary|Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose|Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.|Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||Percent fall in FEV1||Standard Deviation|Mean
1246457|NCT00534937|Secondary|Time to Healing of the Venous Stasis Ulcer|Only 2 time points so no calculation details are necessary. The change is calculated as the later time point minus the earlier time point (e.g., 12 weeks minus baseline).|Baseline to 12 weeks|Time to healing can only evaluate the patients that showed healing during the 12 week study therefore the number may not be consistent with other numbers.|||days||Standard Deviation|Mean
1246458|NCT00534937|Secondary|Percentage Change in Volume of the Affected Limb (-Reduction; +Increase)||12 weeks|Number of participants who completed 12 weeks of treatment without healing. Also limb volume measures must have been present.|||percentage of change||Standard Deviation|Mean
1246461|NCT00534833|Secondary|Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.|||Participants|||Number
1246462|NCT00534833|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination|Day 28 post-vaccination|Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1246463|NCT00534833|Primary|Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria.~Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio."|28 Days post-vaccination|Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.|||Participants|||Number
1246464|NCT00534794|Secondary|Ocular Comfort Score at 12 Hours|Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.|12 hours||||units on a scale||Standard Deviation|Mean
1246465|NCT00534794|Primary|Change in Ocular Itch Score From Baseline|Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.|0 hours, 12 hours||||units on a scale||Standard Deviation|Mean
1246466|NCT00534638|Secondary|Number of Male Subjects Reporting Any SAEs That Are Causally Related to Vaccination, in All Male Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from dose1-Day 0 to Visit 5-18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1246467|NCT00534638|Secondary|Number of Female Subjects Reporting Any SAEs That Are Causally Related to Vaccination, in a Female Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Dose 1-Day 0 to Visit 5-18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available|||Subjects|||Number
1246468|NCT00534638|Secondary|Number of Female Subjects With New Onset of Autoimmune Diseases (NOADs).|NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.|Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1246469|NCT00534638|Secondary|Number of Subjects Reporting Pregnancies With Onset During the Study|Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy. One additional pregnant subject was lost to follow-up during the study.|Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)|The analysis was based on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which all vaccinated subjects for whom data were available.|||Subjects|||Number
1246470|NCT00534638|Secondary|Titres for Anti-HPV-16 and Anti-HPV-18 Antibodies, by Gender, in a Subset of Subjects.|The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.|At the time of visits 1 and 4 (at Day 0 and Month 7) and at the time of Visit 5 (18.5 years of age)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. Subjects who acquired either HPV-16 or HPV-18 infection during the trial were excluded from the ATP cohort for immunogenicity.|||Titres||95% Confidence Interval|Geometric Mean
1246471|NCT00534638|Secondary|Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects.|The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.|At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. Subjects who acquired either HPV-16 or HPV-18 infection during the trial were excluded from the ATP cohort for immunogenicity.|||Subjects|||Number
1246472|NCT00534638|Secondary|Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period up to the Visit 5 (18.5 years of age)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1246473|NCT00534638|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Dose 1 (at Day 0) until Month 12|The analysis was based on the Total Vaccinated Cohort subset of Male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B Group male subjects.|||Number|||Number
1246474|NCT00534638|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects.|MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.|From Dose 1 (at Day 0) until Month 12|The analysis was performed on the Total Vaccinated Cohort - Diary Card subset - a subset of male adolescents from the Cervarix/Engerix-B and Engerix-B Groups, selected for active assessment of safety using diary cards.|||Subjects|||Number
1246475|NCT00534638|Secondary|Number of Subjects Reporting Rash and Urticaria, in a Subset of Subjects.||Within 30 minutes following vaccination|This analysis was based on the Total Vaccinated Cohort - the Diary Card subset - a subset of male adolescents from Cervarix/Engerix-B A and Engerix-B Groups selected for active assessment of safety using diary cards.|||Subjects|||Number
1246476|NCT00534638|Secondary|Number of Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after any vaccination|This analysis was based on the Total Vaccinated Cohort - the Diary Card subset - a subset of male adolescents from Cervarix/Engerix-B A and Engerix-B Groups selected for active assessment of safety using diary cards.|||Subjects|||Number
1246477|NCT00534638|Secondary|Number of Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0 - 6) after any vaccination|The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.|||Subjects|||Number
1246478|NCT00534638|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0 - 6) after any vaccination|The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.|||Subjects|||Number
1246479|NCT00534638|Secondary|Number of Female Subjects With Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Serotypes|The analysis of total effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in HPV vaccinated subjects from the investigated group (prevalence rate in HPV vaccinated subjects from the investigated arm/prevalence rate in all subjects from Arm C).|At the time of visit 5 (at 18.5 years of age)|The analysis was based on the female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5.|||Subjects|||Number
1246480|NCT00534638|Primary|Number of Female Subjects With Vaccine Overall Effectiveness Against Genital Infection With Human Papilloma Virus (HPV) 16/18 Serotypes|The analysis of overall effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated arm/prevalence rate in all subjects from Arm C).|At the time of visit 5 (at 18.5 years of age)|The analysis was based on the female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5.|||Subjects|||Number
1246481|NCT00534599|Secondary|Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||Participants|||Number
1246482|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in CGI-S Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
1246483|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
1246484|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score|Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
1246485|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
1246486|NCT00534599|Secondary|Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||Mean change from randomization||Standard Deviation|Mean
1246487|NCT00534599|Secondary|Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||Mean change from randomization||Standard Deviation|Mean
1246488|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score|"The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer.~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
1246489|NCT00534599|Secondary|Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8|Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||Participants|||Number
1246490|NCT00534599|Secondary|Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8|Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||Participants|||Number
1246491|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score|"The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
1246492|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score|The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
1246493|NCT00534599|Secondary|"Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8"|"This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'.~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||Participants|||Number
1246494|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score|"The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
1246495|NCT00534599|Primary|Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value."|Baseline (randomization) and then 8 weeks|Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized.|||units on scale||95% Confidence Interval|Least Squares Mean
1246496|NCT00534495|Primary|Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS||At Weeks 0- 24||||events|||Number
1246497|NCT00534495|Secondary|Number of Participants With Presence of Systemic Features ( Fever, Rash)||At Weeks 4, 12 and 24|At week 4 ,Rilonacept 36 and Placebo 34 participants , at week 12 , Rilonacept 33 and 29 Placebo participants , and at week 24 combined group with 57 participants, at baseline Rilonacept 36 and Placebo 35 participants.|||participants|||Number
1246992|NCT00530920|Secondary|Time to Cmax (Tmax) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h||Geometric Coefficient of Variation|Geometric Mean
1246498|NCT00534495|Secondary|Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)|"Childhood Health Assesment Questionairre dissability index (C-HAQ)-DI, Disability Index Calculation:~The index is calculated by adding the scores for each of the categories and dividing by the number of categories answered. This gives a score in the 0 to 3.0 range. lower is better"|At Weeks 12 and 24|36 Rilonacept and 35 placebo at baseline , 36 Rilonacept and 34 placebo at week 4, 33 Rilonacept and 29 placebo at week 12, and 57 combined at week 24.|||units on a scale||Inter-Quartile Range|Median
1246499|NCT00534495|Secondary|Pediatric Quality of Life Inventory|Visual Analog Score (0-100 mm) 0 very well , 100 very poor|At Weeks 4, 12 and 24|At Week 4 ,36 Rilonacept and 34 Placebo patient. At week 12, Rilonacept 33 patients and Placebo 29.At baseline Rilonacept 36 and Placebo 35 participants.|||units on a scale||Inter-Quartile Range|Median
1246500|NCT00534495|Secondary|Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70||At Week 4 and week 12|Participants in the study at week 4 (rilonacept 35 and placebo 33).Participants in the study at week 12 ( Rilonacept 33 and placebo 29).|||participants|||Number
1246501|NCT00534495|Primary|Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids||At Week 12||||weeks||Inter-Quartile Range|Median
1246502|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Physical Functioning)|The subject rates each question about physical functioning on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available. Note that 4 items only had data available from 27 participants rather than 28.|||percentage of participants|||Number
1246503|NCT00534417|Post-Hoc|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|OS was measured from day 1 of treatment until time of death from any cause, up to 32.5 months.|14 patients had died, and 27 patients were censored in the OS analysis.|||Months||95% Confidence Interval|Median
1246504|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)|The subject rates each question about psychiatric symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available.|||percentage of participants|||Number
1246505|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Physical Symptoms)|The subject rates each question about physical symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available.|||percentage of participants|||Number
1246506|NCT00534417|Primary|Progression-free Survival (PFS)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, up to 32.5 months.|21 patients had experienced disease progression, and three had died. 17 patients were censored in PFS analysis.|||Months||95% Confidence Interval|Median
1246507|NCT00534417|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%.|Response to treatment was assessed after every 8 weeks of treatment||||percentage of participants||95% Confidence Interval|Number
1246508|NCT00534417|Secondary|Overall Response Rate|Overall response rate was defined as the percentage of participants experiencing complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment||||percentage of participants||95% Confidence Interval|Number
1246509|NCT00534417|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment||||participants|||Number
1246510|NCT00534417|Primary|Time to Progression (TTP)|Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.|TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.|21 patients had experienced disease progression. 20 patients were censored in TTP analysis. The 3 deaths in the PFS analysis were censored for the TTP analysis.|||Months||95% Confidence Interval|Median
1246513|NCT00534404|Primary|Self-reported 6-month Prolonged Abstinence From Smoking|Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.|Measured at 9 Months post-randomization|All currently enrolled participants were invited via email to complete an online follow-up survey. Participants who did not respond to the email received phone calls from study staff asking them to complete the survey online. Results to this outcome measure are from those subjects who completed the survey.|||participants|||Number
1246514|NCT00534365|Secondary|Incontinence Severity Index Score|The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).|12 months||||units on a scale||Standard Deviation|Mean
1246515|NCT00534365|Secondary|Patient Global Impression Improvement||12 months|Please note that no all participants conducted the global improvement scale survey due to loss to follow up.|||Participants|||Count of Participants
1246516|NCT00534365|Secondary|Long Term Complications > 6 Weeks||6 weeks-12 months||||participants|||Number
1246517|NCT00534365|Secondary|Post Operative Complications at 6 Week or Less||6 week||||participants|||Number
1246518|NCT00534365|Primary|Subjective Cure of Urinary Incontinence at 12 Months After Surgery|Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.|12 months|Analysis based on per protocol enrollment|||Participants|||Count of Participants
1246519|NCT00534352|Secondary|CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)||Baseline, Day 8, 14, 22, 28 & 42 and Week 48|ITT (Observed)|||Percent Change from Baseline||Full Range|Median
1246520|NCT00534352|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)|CD4+ Cell Count (x 10^6 cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case).|Baseline, Day 8, 14, 22, 28 & 42 ans Week 48||||x 10^6 cell/L||Full Range|Median
1246521|NCT00534352|Secondary|Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)|Log10 Viral Load (HIV-1 RNA copies/mL): Mean Changes From Baseline(ITT-Observed Case).|Baseline, Day 8, 14, 22, 28 & 42 and Week 48|ITT (Observed)|||copies/mL||Standard Error|Mean
1246522|NCT00534352|Secondary|Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)|Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case).|Day 8, 14, 22, 28, 42 and Week 48|ITT|||participants|||Number
1246523|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 48 and Week 48|ITT|||participants|||Number
1246524|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density lipoprotein (LDL) Direct.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 42 and Week 48|ITT|||participants|||Number
1246525|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL)|"Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density lipoprotein (HDL).~Normal Range:~40 - 59 mG/dL 1.03 - 1.53 mmol/L"|Day 1 through 42 and Week 48|ITT|||participants|||Number
1246526|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 42 and Week 48|ITT|||participants|||Number
1246527|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin|"Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin.~Normal Range: 3.0 - 27.0 ulU/mL"|Day 1 through 42 and Week 48||||participant|||Number
1246528|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia.~Worst Grade is based on the DAIDS toxicity grading scale 0-5: No Toxicity-Death."|Day 1 through 42 and Week 48|ITT|||participants|||Number
1246529|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia|"Number of Participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia.~Worst Grade is based on the National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity grading scale, 0,1,2,3,4 and 5 : None, Mild, Moderate, Severe, Life-threatening and Death."|Day 1 through 42 and Week 48|ITT|||participants|||Number
1246530|NCT00534352|Primary|Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av|At visit Days 14 & 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose.|6 weeks|Intention To Treat (ITT) population|||participants|||Number
1246558|NCT00534209|Secondary|Overall Survival (Phase 2)|The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that study participants are still alive.|Date of randomization to the recorded date of death|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
1247022|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Percent of FEV1 over FVC||Standard Error|Mean
1246531|NCT00534313|Secondary|Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169|The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication at any time. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants|||Number
1246532|NCT00534313|Secondary|Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169|PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Day 169 from Baseline|All randomized participants who received treatment and with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.|||Units on a scale||Standard Error|Mean
1246533|NCT00534313|Secondary|Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters|PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.|Days 1, 15, 29, 57, 85, 113, 141, and 169|||||||
1246534|NCT00534313|Secondary|Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept|Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.|Days 1, 15, 29, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.|||µg/mL||Full Range|Geometric Mean
1246535|NCT00534313|Secondary|Short-term Period: Mean Serum Concentrations of Abatacept|Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.|Days 1, 15, 29, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.|||µg/mL||Standard Deviation|Mean
1246536|NCT00534313|Secondary|Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169|PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Day 169 from Baseline|All randomized and treated participants with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.|||Units on a scale||Standard Error|Mean
1246537|NCT00534313|Secondary|Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)|Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody].|From Baseline to Day 169|Participants who received abatacept and for whom baseline and at least 1 additional measurement were available during the double-blind (short-term) period.|||Participants|||Number
1246538|NCT00534313|Secondary|Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169|Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study drug in double-blind (short-term) period. Only participants with both baseline and postbaseline values included. Missing values at Day 169 were imputed using the last observation carried forward values, except for participants with only baseline value.|||Percentage of change||Standard Error|Mean
1246539|NCT00534313|Secondary|Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169|Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication in double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants|||Number
1246559|NCT00534209|Secondary|Response to Second-line Chemotherapy After Disease Progression (Phase 2)|The percentage of patients experiencing a clinical response (complete response (CR), partial response (PR), stable disease (SD)) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls.|From Week 1 of Study Therapy until Death or Withdrawal of Consent|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
1246540|NCT00534313|Secondary|Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period.|||Participants|||Number
1246541|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis|Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4).|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n = number of participants with evaluable results (each arm respectively).|||Participants|||Number
1246542|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results.|||Participants|||Number
1246543|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or <LLN.|Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).|||Participants|||Number
1246544|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry|ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx.|Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).|||Participants|||Number
1246545|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).|||Participants|||Number
1246546|NCT00534313|Primary|Short-term Period: Number of Participants With ACR 20 Response at Day 169|An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant’s assessment of disease activity, participant’s global assessment of disease activity, investigator’s global assessment of disease activity, participant’s assessment of physical function by HAQ–DI, and Disease Activity Score 28-C reactive protein.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication in the double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants|||Number
1246547|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Hematology|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).|||Participants|||Number
1246548|NCT00534313|Secondary|Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729|Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.|Days 365 and 729 from baseline|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with responses available)|||Participants|||Number
1246575|NCT00534001|Secondary|Abstinence|Bioverified 4-week continuous abstinence|4 weeks||||Participants|||Count of Participants
1246549|NCT00534313|Secondary|Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729|PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Days 365 and 729 from baseline||||Units on a scale||Standard Error|Mean
1246550|NCT00534313|Secondary|Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729|Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.|From Baseline to Days 365 and 729|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period.|||Percentage of change||Standard Deviation|Mean
1246551|NCT00534313|Secondary|Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729|IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).|From Day 169 to Days 365 and 729|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)|||Participants|||Number
1246552|NCT00534313|Secondary|Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729|An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.|At Days 365 and 729 from Baseline|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)|||Percentage of participants||95% Confidence Interval|Number
1246553|NCT00534313|Primary|Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest|Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.|From Day 169 to Day 729|All participants who received at least 1 infusion of abatacept during the long-term period.|||Participants|||Number
1246554|NCT00534248|Secondary|Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period|"A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing~hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|Through 42 days post-vaccination|All participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.|||participants|||Number
1246555|NCT00534248|Secondary|Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group|VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.|6 Weeks|Random subcohort population included 10% of all randomized participants randomly selected for immunogenicity assay, were vaccinated (according to actual treatment received), had results at prevaccination and at 6 weeks postvaccination. Results from participants with protocol violations that may impact the immunogenicity analysis were excluded.|||gpELISA units/mL||95% Confidence Interval|Mean
1246556|NCT00534248|Primary|Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group|Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.|2 Years|Intent-to-treat population defined as all participants randomized in the study according to the planned treatment, Zostavax or placebo, they were assigned.|||number of HZ cases/1000 person-years||95% Confidence Interval|Mean
1246557|NCT00534209|Secondary|Correlative Immunological Studies in Study Participants (Phase 2)|The time course of patients’ adaptive immune response to B7 vaccination as compared to control vaccine will be characterized by their CD8, CD4, and NK response (measured by ELI-spots for interferon-gamma (IFN-γ), interleukin 4 (IL-4), and granzyme B secretion) measured prior to vaccination (i.e. at baseline) and over two courses of vaccination (measurements at week 7 and 13).|Baseline, Week 7 and Week 13|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
1246576|NCT00534001|Primary|Prequit Change in Cigarettes Per Day|Prequit Change in Cigarettes Per Day|3-Week PreQuit Drug Manipulation Phase|Excludes participants with missing data (2 in Arm 1, 3 in Arm 2)|||Cigarettes Per Day||Standard Error|Mean
1246560|NCT00534209|Secondary|Safety Profile (Phase 2)|The rate of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.|About 13 weeks|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
1246561|NCT00534209|Secondary|Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2)|Relationship of CD8 response in B7-vaccinated patients to their progression-free survival. Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact).|From Week 1 of Study Therapy until Death or Withdrawal of Consent|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
1246562|NCT00534209|Secondary|Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2)|Rate of immune response (CD8) in B-7 vaccinated participants reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses.|About 13 weeks|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
1246563|NCT00534209|Primary|Progression-free Survival (Phase 2)||Date of randomization to the earliest date of documented progression.|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
1246564|NCT00534209|Primary|Preliminary Safety Profile (Phase 1)|This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.|Up to 13 weeks||||participants|||Number
1246565|NCT00534105|Secondary|LDL|LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum||||mg/dl||Inter-Quartile Range|Mean
1246566|NCT00534105|Secondary|HDL|Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum||||mg/dl||Inter-Quartile Range|Mean
1246567|NCT00534105|Secondary|Triglyceride Values|Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum||||mg/dl||Inter-Quartile Range|Mean
1246568|NCT00534105|Primary|Cholesterol|Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls|Postpartum||||mg/dl||Inter-Quartile Range|Mean
1246569|NCT00534092|Other Pre-specified|Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study||3+ years following first 2 years post-X-STOP implant through IDE study||||participants|||Number
1246570|NCT00534092|Other Pre-specified|Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study|The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.|3+ years following first 2 years post-X-STOP implant through IDE study||||participants|||Number
1246571|NCT00534092|Secondary|Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)|Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 “worst” to 100 “best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.|Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study||||units on a scale||Standard Deviation|Mean
1246572|NCT00534092|Secondary|Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.|3+ years following first 2 years post-X-STOP implant through IDE study||||units on a scale||Standard Deviation|Mean
1246573|NCT00534092|Secondary|Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.|Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study||||units on a scale||Standard Deviation|Mean
1246574|NCT00534092|Primary|Treatment Success Rates (At ≥ 5 Years)|Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of <2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.|3+ years following first 2 years post-X-STOP implant through IDE study|Patients who received the X-STOP and 1) completed the IDE trial or CAP/COS under IDE #G990128 or 2) were participating in the CAP/COS program, were eligible for the LTOS study. 55 included in analysis met moderately impaired baseline physical function. 14 had mildly impaired physical function at baseline and were analyzed as separate safety cohort.|||percentage of participants|||Number
1246577|NCT00533949|Secondary|Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Control||From randomization to date of failure (either local or regional), death or last follow-up. Analysis occurs after 339 deaths have been reported.||2018-08-31|08/2018||||
1246578|NCT00533949|Secondary|Prognostic and Predictive Effects of Gross Tumor Volume on Overall Survival||From randomization to date of death or last follow-up. Analysis occurs after 339 deaths have been reported.||2018-08-31|08/2018||||
1246579|NCT00533949|Secondary|Correlation of Tumor Markers With Overall Survival, Local-regional Failure, and QOL|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|Analysis occurs after 339 deaths have been reported, estimated at 5.6 years from start of study, unless a futility bound is crossed prior to that.|||||||
1246580|NCT00533949|Secondary|Quality-adjusted Survival Based on EuroQoL (EQ5D)-Derived Health Utility Score||From start of treatment to 24 months.||2018-08-31|08/2018||||
1246581|NCT00533949|Secondary|Patient-reported Swallowing Ability||From start of treatment to 24 months.||2018-08-31|08/2018||||
1246582|NCT00533949|Secondary|Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI).|A decline of 2 points in the LCS from baseline to 3 months was considered a clinically meaningful change indicating a decline in quality of life. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|At baseline and 3 months.|Eligible patients who enrolled while the high dose arms were open, had baseline and 3 month assessments, and did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1246583|NCT00533949|Secondary|Death During or Within 30 Days of Discontinuation of Protocol Treatment|Deaths regardless of cause and occuring during or within 30 days of discontinuation of protocol treatment were evaluated.|From start of treatment to 24 months.|Eligible patients who started study treatment and did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1246584|NCT00533949|Secondary|Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0|Treatment-related adverse events other than esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|Analysis occurs 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|All eligible patients enrolled while the high dose arms were open, who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1246585|NCT00533949|Secondary|Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0|Treatment-related esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|Analysis occurs after 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|All eligible patients enrolled while the high dose arms were open, who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1246586|NCT00533949|Secondary|Local-regional Failure (Reported as Two-year Estimates)|A failure for local-regional failure is the first occurrence of local or regional progression. Time is measured from the date of randomization to the date of first failure. Patients alive without local or regional failure at the time of last follow-up are censored. Patients who died without local or regional failure are considered as having competing risk at the time of death. Local-regional failure was estimated by the cumulative incidence method and 2 year estimates are reported.|Analysis occurs after 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison.|||percentage of participants||95% Confidence Interval|Number
1246587|NCT00533949|Secondary|Progression-free Survival|A failure for progression-free survival (PFS) is the first occurrence of local or regional progression, distant metastases, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Time is measured from the date of randomization to the date of first failure. Patients without failure are censored at the date of last follow-up.|Analysis occurs after 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison.|||months||95% Confidence Interval|Median
1246588|NCT00533949|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|Analysis occurs after 50 months of accrual and an additional 18 months of follow-up, such that patients are followed at least 18 months from randomization.|"Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison. See Limitations and Caveats."|||months||95% Confidence Interval|Median
1246589|NCT00533897|Secondary|LTE: Mean Temperature (T) During LTE|During LTE, temperature was taken in participants while seated, measured in degrees celsius and was assessed at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449,533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||degrees Celsius||Standard Deviation|Mean
1247023|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Percent of FEV1 over FVC||Standard Error|Mean
1246590|NCT00533897|Secondary|LTE: Mean Heart Rate (HR) During LTE|During LTE, heart rate was taken in participants while seated, measured in beats per minute (bpm) and was assessed at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||bpm||Standard Deviation|Mean
1246591|NCT00533897|Secondary|LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE|During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||mmHg||Standard Deviation|Mean
1246592|NCT00533897|Secondary|LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE|During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261,1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||mm Hg||Standard Deviation|Mean
1246593|NCT00533897|Secondary|LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the LTE period.|||participants|||Number
1246594|NCT00533897|Secondary|LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.|||participants|||Number
1246595|NCT00533897|Secondary|LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.|||participants|||Number
1246596|NCT00533897|Secondary|LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.|||participants|||Number
1246597|NCT00533897|Secondary|LTE: Number of Participants With AEs of Special Interest During LTE|AEs of special interest in LTE are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies, local injection site reaction (pre-specified AEs occurring at the site of SC injection) and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014) up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period|||participants|||Number
1246684|NCT00533507|Primary|Concentration of Anti-Pneumococcal Antibodies|"Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||µg/mL||95% Confidence Interval|Geometric Mean
1246598|NCT00533897|Secondary|LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. SAEs include hospitalizations for elective surgical procedures.All deaths reported during the LTE including those that occurred > 56 days after the last dose. Related AE or SAE defined as AE or SAE with Certain, Probable, Possible, or Missing relationship to study medication. All participants who completed the ST period could enter the open label LTE on Day 253; LI Period 1 non-responders could directly enter the LTE.|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014), up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period|||participants|||Number
1246599|NCT00533897|Secondary|LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using electrochemiluminescence (ECL). The percent of participants with a positive abatacept induced immunogenicity response against cytotoxic T-lymphocyte antigen 4 (CTLA4) and possibly immunoglobulin (Ig), or against Ig and/or Junction Region was calculated by number of participants with a positive response divided by number of participants evaluated. Overall for on-treatment includes treatment visits on Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, and 1989.|Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, 1989 and 28, 56, 85, 168 days post last dose in LTE|All participants treated in LTE period with at least 1 immunogenicity result (ECL) during LTE period. n=number of participants evaluated.|||percentage of participants|||Number
1246600|NCT00533897|Secondary|LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index (DI) was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ DI. Percent=number of participants with HAQ response divided by number of participants in the analysis. Since Period I Non-responders proceeded directly to the LTE at the end of Period I (Day 85), study days do not represent treatment days.|Study Days 1 (Baseline),15, 29, 57, 78, 85, 253, 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541,1625,1709,1821,1905,1989, 2073|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were non-responders at the end of Period 1. n= number of participants with data who were evaluated|||percentage of participants||95% Confidence Interval|Number
1246601|NCT00533897|Secondary|LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE|DAS28:continuous disease measure composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. Low disease activity score: ≤ 3.2. Percent=Number of participants with Low Disease Activity divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1.|||percentage of participants|||Number
1246602|NCT00533897|Secondary|LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE|DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. Clinical remission=DAS28-CRP score<2.6. Percent=Number of participants meeting remission divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available (NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period I non-responders: as of Study Day 85 and up to Study Day 1821. For ST completers: as of Study Day 253 and up to Study Day 1821|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n= number of participants evaluated at each specific timepoint|||percentage of participants|||Number
1246685|NCT00533507|Primary|Concentration of Anti-Protein D Antibodies|Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||EL.U/mL||95% Confidence Interval|Geometric Mean
1246707|NCT00533273|Secondary|Clinical Improvement in Primary Joint After the Last Injection|Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, Within 30 days after last injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
1246603|NCT00533897|Secondary|LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE|DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. DAS28-CRP has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n=number of participants with both baseline and post-baseline measurements.|||units on a scale||Standard Error|Mean
1246604|NCT00533897|Secondary|ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups|Venous blood was collected and tested for anti-nuclear antibodies, anti-dsDNA antibodies, and rheumatoid factor. ANA were detected by means of immunofluorescent antibodies. An anti-DNA radioimmunoassay was used for detection of anti-dsDNA antibodies (Diagnostic Products Corporation). RF was measured by an immunoturbidimetric assay (Roche Tina-Quant). Determinations of antibody or RF status were made at baseline and Day 253.|Baseline, Day 253|Participants treated in DBW period with at least 1 immunogenicity result (immunofluorescence, radioimmunoassay, or immunoturbidimetry) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||participants|||Number
1246605|NCT00533897|Secondary|Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ECL.|Day 197 through Day 253|Participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||ug/mL||Standard Deviation|Mean
1246606|NCT00533897|Secondary|Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ELISA.|Day 197 through Day 253|Participants treated during the RI Period with at least 1 immunogenicity result (ELISA) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||ug/mL||Standard Deviation|Mean
1246607|NCT00533897|Secondary|RI Period; Mean Temperature (T) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||degrees Celsius||Standard Deviation|Mean
1246608|NCT00533897|Secondary|RI Period; Mean Heart Rate (HR) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||beats per minute (bpm)||Standard Deviation|Mean
1246609|NCT00533897|Secondary|RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||mm mercury (Hg)||Standard Deviation|Mean
1246610|NCT00533897|Secondary|RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.|||participants|||Number
1246611|NCT00533897|Secondary|RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.|||participants|||Number
1246686|NCT00533442|Secondary|Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant.|Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant.|at 1-5 years post-transplant|Number analyzed here includes all patients alive with a functioning graft that had an available measurement taken at that time|||ng/mL||Standard Error|Mean
1246612|NCT00533897|Secondary|RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.|||participants|||Number
1246613|NCT00533897|Secondary|RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.|||participants|||Number
1246614|NCT00533897|Secondary|RI; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period.|||participants|||Number
1246615|NCT00533897|Secondary|RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period.|||participants|||Number
1246616|NCT00533897|Secondary|DBW Period; Mean Temperature (T) During Period II|Participants were seated and temperature taken just prior to study drug injection.|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||degrees Celsius||Standard Deviation|Mean
1246617|NCT00533897|Secondary|DBW Period; Mean Heart Rate (HR) During Period 2|Heart Rate was taken in participants while seated, just prior to study drug injection, and measured in beats per minute (bpm)|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||beats per minute (bpm)||Standard Deviation|Mean
1246618|NCT00533897|Secondary|DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period|Blood pressures were taken in participants while seated, just prior to study drug injection, and measured in millimeters of mercury (mmHg).|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||mm mercury (Hg)||Standard Deviation|Mean
1246619|NCT00533897|Secondary|DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.|||participants|||Number
1246620|NCT00533897|Secondary|DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.|||participants|||Number
1246993|NCT00530920|Secondary|Terminal Half-Life (t1/2) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h||Geometric Coefficient of Variation|Geometric Mean
1246621|NCT00533897|Secondary|DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.|||participants|||Number
1246622|NCT00533897|Secondary|DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.|||participants|||Number
1246623|NCT00533897|Secondary|DBW; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period|||participants|||Number
1246624|NCT00533897|Secondary|DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period|||participants|||Number
1246625|NCT00533897|Secondary|LI Period; Mean Temperature (T)|Temperature was taken in participants while seated and measured in degrees celsius. Temperature was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.|||degrees Celsius||Standard Deviation|Mean
1246626|NCT00533897|Secondary|LI Period; Mean Heart Rate (HR)|Heart rate was taken in participants while seated and measured in beats per minute (bpm). Heart rate was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.|||bpm||Standard Deviation|Mean
1246627|NCT00533897|Secondary|LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was taken in participants while seated and measured in millimeters of mercury (mmHg). Pressures were assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.|||mmHg||Standard Deviation|Mean
1246628|NCT00533897|Secondary|LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*upper limits of normal (ULN),or if BL< lower limits of normal (LLN) then use 0.8*BL or > upper limits of normal (ULN),or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >ULN,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis: Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells (RBCs), White Blood Cells (WBCs):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during LI period.|||participants|||Number
1246687|NCT00533442|Secondary|Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.|Comparisons of renal function (eGFR, measured in mL/min/1.73 m^2) at 12, 36, and 60 months post-transplant.|at 1-5 years post-transplant|Number analyzed here includes all patients alive with a functioning graft that had an available measurement taken at that time|||mL/min/1.73m^2||Standard Error|Mean
1246629|NCT00533897|Secondary|LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.|||participants|||Number
1246630|NCT00533897|Secondary|LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.|||participants|||Number
1246631|NCT00533897|Secondary|LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/ microliter (uL); eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.|||participants|||Number
1246632|NCT00533897|Secondary|LI Period; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period|||participants|||Number
1246633|NCT00533897|Secondary|LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period|||participants|||Number
1246634|NCT00533897|Secondary|RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 169 (Period III Baseline), 197, 225, and 253|Participants who received at least 1 dose of study medication during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at RI period baseline.|||units on a scale||Standard Error|Mean
1246635|NCT00533897|Secondary|DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time|"A participant had an RA flare if at least 2 of the following criteria were met:~Doubling of tender and swollen joint count from Day 78~Increase in DAS28-CRP score ≥ 1.2 from Day 78~Prematurely discontinued from Double-blind Withdrawal Period (Period 2) and continued to Re-introduction Period (Period 3)"|Days 85, 113, 141, and 169|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
1246636|NCT00533897|Secondary|DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 85 (Period 2 Baseline), 113, 141, and 169|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at DBW period baseline.|||units on a scale||Standard Error|Mean
1246688|NCT00533442|Primary|Event-Specific Survival Comparisons|Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival.|over 1-10 years post-transplant||||Participants|||Count of Participants
1246637|NCT00533897|Secondary|LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 15, 29, 57, 78, 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||percentage of participants|||Number
1246638|NCT00533897|Secondary|LI; Mean Change in DAS 28 (CRP) From Baseline Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 1 (Baseline), 15, 29, 57, 78, 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||units on a scale||Standard Error|Mean
1246639|NCT00533897|Secondary|Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||percentage of Participants|||Number
1246640|NCT00533897|Secondary|Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||units on a scale||Standard Error|Mean
1246641|NCT00533897|Secondary|Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 85, 169, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and, when relevant, at baseline.|||percentage of participants|||Number
1246642|NCT00533897|Secondary|Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups|The DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||units on a scale||Standard Error|Mean
1246643|NCT00533897|Secondary|Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug|All participants treated in DBW period with at least 1 immunogenicity result (ECL) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of Participants|||Number
1246689|NCT00533351|Primary|Change From Baseline in Daily Pain Score at Week 2|Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed|Baseline, Week 2|Due to low number of patients completing the treatment period of the study no analyses were performed||||||
1246644|NCT00533897|Secondary|Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups|Serum samples from Abatacept-treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. ST was defined as the LI Period, the DBW Period, and the RI Period (Days 1-253).|For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug|All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
1246645|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
1246646|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
1246647|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL At Post Visits|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|Day 22 after last dose of drug to Day 85 after last dose of drug|These data were not summarized since there were no participants at any post visits||||||
1246648|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period|All participants treated in DBW period with at least 1 immunogenicity result (ECL) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
1246649|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 22 after last dose of drug to Day 85 after last dose of drug|These data were not summarized since there were no participants at any post visits.||||||
1246650|NCT00533897|Primary|Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 253 (short term)|Participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
1246651|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. Samples were obtained during treatment (TRT) visits.|Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period|All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
1246690|NCT00533351|Secondary|Change From Baseline in Subject Global Impression of Change Score at Week 2|Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed.|Baseline, Week 2|Due to low number of patients completing the treatment period of the study no analyses were performed.||||||
1246652|NCT00533897|Secondary|LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in Period 1 (Lead-in Period). N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
1246653|NCT00533897|Secondary|Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in LI Period who had at least 1 immunogenicity result (ELISA) during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
1246654|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 253 (short term)|Participants treated with Placebo in DBW period who were treated in RI period and had at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
1246655|NCT00533897|Primary|Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 169|Participants treated in the DBW Period with at least 1 immunogenicity result (ELISA) during DBW Period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
1246656|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 14|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 14 (21-day cycle)|Zero participants were analyzed.||||||
1246657|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 7|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 7 (21-day cycle)|Zero participants were analyzed.||||||
1246658|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 1|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 1 (21-day cycle) 1-hour post infusion|Zero participants were analyzed.||||||
1246659|NCT00533702|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks|Response rate was defined as a CR or a PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.|12 weeks (4 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.|||percentage of participants|||Number
1246660|NCT00533702|Secondary|Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks|Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. Stable Disease (SD) was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.|12 weeks (4 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.|||percentage of participants|||Number
1246661|NCT00533702|Secondary|Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks|Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. SD was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.|6 weeks (2 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.|||percentage of participants|||Number
1246708|NCT00533273|Primary|Reduction in Primary Joint Contracture to 5° or Less|Successfully treated or clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after last injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
1246662|NCT00533702|Secondary|Duration of Response|The duration of overall response was defined as the time from first assessment of complete response (CR) or partial response (PR) to the first date of progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), initiation of other or additional antitumor therapy, or death from any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. PD was defined as at least 20% increase in sum of longest diameter of target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.|Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug and who had CR or PR. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=2; IMC-1121B (ramucirumab)=0.|||months||95% Confidence Interval|Median
1246663|NCT00533702|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|The ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.|Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1246664|NCT00533702|Secondary|Number of Participants With Adverse Events (AE)|The number of participants who experienced any IMC-1121B (ramucirumab [RAM]) treatment-related and treatment emergent AE (TEAE), treatment-related TEAE of Grade ≥3, treatment-related TE serious AEs (SAEs), treatment-related TEAE resulting in death (Grade 5 AE) and any TEAEs resulting in death. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 40 months|Safety Population: All enrolled participants who were treated with any quantity of study drug.|||participants|||Number
1246665|NCT00533702|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.|Baseline up to 36 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=9; IMC-1121B (ramucirumab)=4.|||months||95% Confidence Interval|Median
1246666|NCT00533546|Secondary|National Institutes of Health Stroke Scale (NIHSS)|"The NIHSS is a measure of neurologic deficit on a scale of 0-42, with 0 being normal. The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. The 11 items are:~Level of Consciousness Horizontal Eye Movement Visual field test Facial Palsy Motor Arm Motor Leg Limb Ataxia Sensory Language Speech Extinction and Inattention"|90 days||||units on a scale||Standard Deviation|Mean
1246667|NCT00533546|Secondary|Mean Barthel Index Score|"Measure of functional recovery using Barthel Index (range 0-100). The Barthel scale or Barthel ADL index is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility with 10 points given to each variable for a total of 100 points. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The ten variables addressed in the Barthel scale are:~presence or absence of fecal incontinence presence or absence of urinary incontinence help needed with grooming help needed with toilet use help needed with feeding help needed with transfers (e.g. from chair to bed) help needed with walking help needed with dressing help needed with climbing stairs and help needed with bathing"|90 days||||units on a scale||Standard Deviation|Mean
1246668|NCT00533546|Secondary|Mean Modified Rankin Scale Score|"Measure of disability as determined by categorical assignment on modified Rankin Scale.. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.~The scale runs from 0-6, running from perfect health without symptoms to death.~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead."|90 days||||units on a scale||Standard Deviation|Mean
1246691|NCT00533273|Secondary|Change From Baseline Range of Motion in Non-Primary Joint After the First Injection|Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion prior to the next injection − baseline range of motion|Baseline, Day 30 after first injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Degrees|Joints|Standard Deviation|Mean
1247024|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1246669|NCT00533546|Primary|Number of Participants With Intracranial Hemorrhage|"Intracranial Hemorrhage (ICH):~Fatal ICH: Death ascribed to ICH confirmed by autopsy or CT imaging. Major non-fatal ICH: Hemorrhage within brain parenchyma associated with neurological deterioration or evidence of subdural, epidural or intraventricular hemorrhage on CT imaging, with or without symptoms.~Symptomatic ICH: Hemorrhage within the territory of qualifying infarction with neurological deterioration as measured by > 2 point increase in the National Institutes of Health Stroke Scale (NIHSS) from previous examination; hemorrhage in different vascular territory associated with new neurologic deficit. All symptomatic ICH will be defined as a major ICH.~Asymptomatic ICH: Presence of hemorrhage within the territory of qualifying infarction without neurological deterioration ascribed to the hemorrhage or presence of hemorrhage within brain parenchyma outside the territory of qualifying infarction without new neurologic deficit (would not be considered a major ICH)"|Measured within 36-48 hours of treatment|All participants enrolled were analyzed.|||participants|||Number
1246670|NCT00533507|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Up to one month after the third dose||||subjects|||Number
1246671|NCT00533507|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 31-day (Day 0-30) period after each dose||||subjects|||Number
1246672|NCT00533507|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting|During the 4-day (Day 0-3) period after each dose||||subjects|||Number
1246673|NCT00533507|Secondary|Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value|Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).|Four months after the administration of the second dose of Rotarix™ vaccine|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246674|NCT00533507|Secondary|Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value|Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246675|NCT00533507|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value|Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246676|NCT00533507|Secondary|Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value|Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246677|NCT00533507|Secondary|Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value|Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246678|NCT00533507|Secondary|Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value|Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246679|NCT00533507|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value|Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246680|NCT00533507|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value|Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246681|NCT00533507|Secondary|Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246682|NCT00533507|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|Before the first dose (pre) and one month after (post) the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246683|NCT00533507|Secondary|Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value|Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|Before the first dose (pre) and one month after (post) the third dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1246994|NCT00530920|Secondary|Volume of Distribution (V/F) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||L||Geometric Coefficient of Variation|Geometric Mean
1246692|NCT00533273|Secondary|Percent Reduction From Baseline Contracture of Non-Primary Joint After the First Injection|Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture − last available post-injection contracture prior to next injection)/baseline contracture|Baseline, Day 30 after first injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of change|Joints|Standard Deviation|Mean
1246693|NCT00533273|Secondary|Clinical Improvement in Non-Primary Joint After the First Injection|Clinical improvement in non-primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, Within 30 days after first injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
1246694|NCT00533273|Secondary|Clinical Success in Non-Primary Joint After the First Injection|Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after first injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
1246695|NCT00533273|Secondary|Time to Reach Clinical Success in Non-Primary Joint|Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories|Within 30 days after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
1246696|NCT00533273|Secondary|Change From Baseline Range of Motion in Non-Primary Joint After the Last Injection|Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion − baseline range of motion|Baseline, Day 30 after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Degrees|Joints|Standard Deviation|Mean
1246697|NCT00533273|Secondary|Percent Reduction From Baseline Contracture of Non-Primary Joint After the Last Injection|Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture|Baseline, Day 30 after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of change|Joints|Standard Deviation|Mean
1246698|NCT00533273|Secondary|Clinical Improvement in Non-Primary Joint After the Last Injection|Clinical improvement in non-primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, Within 30 days after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
1246699|NCT00533273|Secondary|Reduction in Non-primary Joint Contracture to 5° or Less After the Last Injection|Successfully treated or clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
1246700|NCT00533273|Secondary|Change From Baseline Range of Motion in Primary Joint After the First Injection|Change in degree of range of motion in primary joint measured as last available post-injection range of motion prior to the next injection − baseline range of motion|Baseline, Day 30 after first injection|Subjects who were randomized and received at least 1 injection|||Degrees|Joints|Standard Deviation|Mean
1246701|NCT00533273|Secondary|Percent Reduction From Baseline Contracture of Primary Joint After the First Injection|Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture − last available post-injection contracture prior to next injection)/baseline contracture|Baseline, Day 30 after first injection|Subjects who were randomized and received at least 1 injection|||Percentage of change|Joints|Standard Deviation|Mean
1246702|NCT00533273|Secondary|Clinical Improvement in Primary Joint After the First Injection|Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, Within 30 days after first injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
1246703|NCT00533273|Secondary|Clinical Success in Primary Joint After the First Injection|Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after first injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
1246704|NCT00533273|Secondary|Time to Reach Clinical Success in Primary Joint|Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories|Within 30 days after last injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
1246705|NCT00533273|Secondary|Change From Baseline Range of Motion in Primary Joint After the Last Injection|Change in degree of range of motion in primary joint measured as last available post-injection range of motion − baseline range of motion|Baseline, Day 30 after last injection|Subjects who were randomized and received at least 1 injection|||Degrees|Joints|Standard Deviation|Mean
1246706|NCT00533273|Secondary|Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection|Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture|Baseline, Day 30 after last injection|Subjects who were randomized and received at least 1 injection|||Percentage of change|Joints|Standard Deviation|Mean
1246709|NCT00533117|Primary|Suicide Attempts|Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)|Assessed bimonthly|"Data was *prespecified* to be collected for the Dialectical Behavior Therapy With or Without Fluoxetine and Supportive Therapy With or Without Fluoxetine Arm/Group combination, therefore the four original treatment conditions were collapsed into 2 study arms for analysis of the primary outcome measure"|||suicide attempt|||Number
1246710|NCT00532948|Secondary|Anti Tumor Activity|Tumor response refers to the best response prior to failure (disease progression, death or second malignancy).|Up to 6 years|Efficacy data of the present study (NO18517 - NCT00532948) were pre-specified to be combined with efficacy data of the Phase 2 portion of this Study, NO21125 (NCT01118377) for analysis. Results are currently posted in the record of Study NO21125.||||||
1246711|NCT00532948|Secondary|The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5’-DFCR, 5’-DFUR, 5-FU and FBAL)|AUC last concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||h*ng/mL||Standard Deviation|Mean
1246712|NCT00532948|Secondary|Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5’-DFCR, 5’-DFUR, 5-FU and FBAL)|Tmax is the corresponding time at which Cmax occurs of capecitabine and its metabolites.Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||Hour||Full Range|Median
1246713|NCT00532948|Secondary|Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5’-Deoxy-5-Fluorocytidine [5’-DFCR], 5’-Deoxy-5-Fluorouridine [5’-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL])|The maximum observed plasma concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||ng/mL||Standard Deviation|Mean
1246714|NCT00532948|Primary|Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters|For blood chemistry, the parameters assessed were: Sodium, potassium, calcium, magnesium, chloride, bicarbonate, total protein, albumin, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Lactate dehydrogenase (LDH), total bilirubin, direct bilirubin, indirect bilirubin, creatinine (serum creatinine or creatinine clearance), glucose.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||Participants|||Number
1246715|NCT00532948|Primary|Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters|For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||Participants|||Number
1246716|NCT00532948|Primary|Number of Participants With Adverse Events (AE)|An AE is an unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was monitored and graded according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Adverse events that were not included in the CTCAEv3.0 were reported and graded under the other AE within the appropriate category.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine.|||Participants|||Number
1246717|NCT00532948|Primary|Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the 11 week dose-finding period: any event that leads to interruption of planned radiation for 5 consecutive days or 10 days total; Grade 4 neutropenia or thrombocytopenia; Grade 3 thrombocytopenia that required a platelet transfusion on 2 or more occasions; any Grade 3 or 4 non-hematologic toxicity (with the exception of grade 3 nausea or vomiting of less than 5 days duration, Grade 3 transaminases that returned to baseline value within 7 days of study drug interruption and that did not recur upon re-challenge with study drug, and/or Grade 3 fever or infection of <5 days duration); Grade 2 non-hematologic toxicities that persisted for >7 days and required treatment interruption, or any other capecitabine-related adverse events that required need for dose reduction or permanent cessation of therapy, interruption of study drug for >7 days or recurred on re-challenge with capecitabine rapidly disintegrating tablets (RDTs).|Upto 11 weeks|The safety population consisted of all eligible patients who received at least one dose of capecitabine.|||Participants|||Number
1246718|NCT00532948|Primary|Maximum Tolerated Dose (MTD) of Capecitabine.|The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.|Upto 11 weeks.|The safety population consisted of all eligible patients who received at least one dose of capecitabine.|||milligrams|||Number
1247025|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1246719|NCT00532935|Secondary|Percent of Participants With A1C <7.0% at Week 32||Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.|||Percent Participants|||Number
1246720|NCT00532935|Secondary|Change From Baseline in FPG at Week 32|Change from baseline reflects the Week 32 FPG minus the baseline FPG|Baseline and Week 32|Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.|||mg/dL||95% Confidence Interval|Least Squares Mean
1246721|NCT00532935|Secondary|Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32|Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG|Baseline and Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.|||mg/dL||95% Confidence Interval|Least Squares Mean
1246722|NCT00532935|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1|Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone|Baseline and Week 1|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome.|||mg/dL||95% Confidence Interval|Least Squares Mean
1246723|NCT00532935|Primary|Change From Baseline in A1C at Week 32|A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent|Baseline and Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
1246724|NCT00532883|Primary|Distribution of the Density of Hemoglobin SC Red Cells|An individuals’ percentage of red blood cells with density greater than 41 g/dL as measured by Advia.|measured 2 months after initiation of treatment|ITT: All randomized subjects who receive any clinical trial material. Subjects in the ITT population will be classified according to the treatment group to which they were randomized, regardless of what study drug they received.|||percent of cells||Standard Deviation|Mean
1246725|NCT00532779|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1246726|NCT00532779|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1246727|NCT00532779|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1246728|NCT00532779|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
1246729|NCT00532779|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
1246730|NCT00532779|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1246731|NCT00532779|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1246995|NCT00530920|Secondary|Maximum Concentration (Cmax) of Tipranavir|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
1246732|NCT00532779|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1246733|NCT00532779|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1246734|NCT00532779|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1246735|NCT00532779|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1246736|NCT00532779|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1246737|NCT00532779|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1246738|NCT00532779|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1246739|NCT00532779|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||cm||Standard Error|Least Squares Mean
1246740|NCT00532779|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1246741|NCT00532779|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1246742|NCT00532779|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
1246743|NCT00532493|Secondary|Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)|Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of >=4 for male and a score of >=3 for female meets the criteria for alcohol use disorders.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246744|NCT00532493|Secondary|Quality of Life Inventory (QOLI)|Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246745|NCT00532493|Secondary|SF-12 Mental Standardized Score (SF-12 MCS)|Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246746|NCT00532493|Secondary|SF-12 Physical Standardized Score (SF-12 PCS)|Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246747|NCT00532493|Secondary|Patient Health Questionnaire-9 (PHQ9)|Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1247014|NCT00530842|Secondary|Dyspnea and Leg Discomfort|Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10)|8 weeks|FAS using imputed values|||Unit on a Scale||Standard Deviation|Mean
1246748|NCT00532493|Secondary|PTSD Checklist-Military Version (PCL-M) Score|Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.|This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246749|NCT00532493|Primary|Clinical Global Impression of Change (CGIC)|Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10|||scores on a scale||Standard Deviation|Mean
1246750|NCT00532493|Secondary|Total CAPS Score|Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.|The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246751|NCT00532493|Secondary|Clinical Global Impression of Change|Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.|This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246752|NCT00532493|Secondary|CAPS Recurrent Distressing Dreams Item|Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246753|NCT00532493|Secondary|Pittsburgh Sleep Quality Index|Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
1246754|NCT00532493|Primary|Pittsburgh Sleep Quality Index (PSQI)|Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10|||scores on a scale||Standard Deviation|Mean
1246755|NCT00532493|Primary|CAPS Recurrent Distressing Dreams Item|Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10|||scores on a scale||Standard Deviation|Mean
1246756|NCT00532480|Primary|17-item Hamilton Depression Rating Scale|Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.|8 weeks|10 patients included in the study out of which 7 completed 8 weeks of the study|||units on a scale||Standard Deviation|Mean
1246757|NCT00532441|Secondary|Overall Survival|Determine Overall Survival|18 Months||||months||95% Confidence Interval|Median
1246758|NCT00532441|Secondary|Response Rate|Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)|18 months||||participants|||Number
1246759|NCT00532441|Primary|16 Weeks Progression-free Survival|To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|Start of treatment until disease progression per RECIST criteria up to 16 weeks||||months||95% Confidence Interval|Median
1246760|NCT00532298|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1246835|NCT00531934|Secondary|Duration of Skin Rash (Folliculitis) During the Whole Treatment Period|If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population; only participants with an event (folliculitis) were included in the analysis.|||days||Standard Deviation|Median
1246761|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1246762|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1246763|NCT00532298|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1246764|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Subjects|||Number
1246765|NCT00532298|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1246766|NCT00532298|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Subjects|||Number
1246767|NCT00532298|Secondary|The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.|||Subjects|||Number
1246768|NCT00532298|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Day 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.|||fold increase||95% Confidence Interval|Geometric Mean
1246769|NCT00532298|Secondary|The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Day 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.|||Subjects|||Number
1246770|NCT00532298|Secondary|HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations|Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.|||titer||95% Confidence Interval|Geometric Mean
1246836|NCT00531934|Secondary|Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment|If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death.|Days 0, 14, 28 and Months 2, 3, and 4|ITT Population; only participants with an event (folliculitis) were included in the analysis.|||days||Standard Deviation|Mean
1246771|NCT00532298|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available. This primary outcome was assessed only on those groups receiving any of the GSK Bio's influenza vaccine GSK576389A formulations.|||titer||95% Confidence Interval|Geometric Mean
1246772|NCT00532259|Secondary|Overall Survival||within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).||||Percent||90% Confidence Interval|Number
1246773|NCT00532259|Primary|Progression-free Survival|PFS (progression-free survival ) will be determined at the eligible patient populations|16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).|Patients who did not meet key study entry criteria were excluded from the eligible data set.|||Percent||90% Confidence Interval|Number
1246774|NCT00532155|Secondary|Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI)|HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies, and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.|ITT population with questionnaires evaluable for ABSI.|||units on a scale||Standard Deviation|Mean
1246775|NCT00532155|Secondary|Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS)|HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.|ITT population with questionnaires evaluable for LCSS.|||units on a scale||Standard Deviation|Mean
1246776|NCT00532155|Secondary|Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria|"Participants with OR were those who had a confirmed complete response [CR] or a confirmed partial response [PR], based on RECIST criteria, in which~CR refected the disappearance of all tumor lesions (with no new tumors)~PR reflected a pre-defined decrease in tumor burden - a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~OR was CR + PR The response rate was the percent of participants with a response.~To determine a response, tumors were assessed by the investigators using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 – 6 weeks."|Baseline to data cut-off (26 January 2011)|Evaluable population: All ITT participants with measurable disease at study entry, and with at least one valid post baseline tumor evaluation, except if the participant died due to progressive disease or had documented (ie, radiological) progression before having any post-baseline tumor evaluation.|||percentage of participants|||Number
1246777|NCT00532155|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time interval between the date of randomization and the time of occurrence of the first radiological tumor progression detected by a computer tomography (CT) scan and /or by Magnetic Resonance Imaging (MRI); or death due to any cause; whichever was earlier. Participants without disease progression were censored at the earliest date between their last valid tumour assessment and the data cutoff date.~PFS was estimated from Kaplan-Meier Curves."|Baseline to data cut-off (26 January 2011)|Intent to treat (ITT) population. The results are based on a total of 865 PFS events (434 in the placebo group and 431 in the aflibercept group) at the time of cutoff.|||months|Participants|95% Confidence Interval|Median
1246778|NCT00532155|Primary|Overall Survival (OS)|"OS was time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, overall survival time was censored at the last date the participant was known to be alive, or the study cutoff date, whichever was earlier. The cut-off date for the OS was date when 687 deaths were observed.~OS was estimated from Kaplan-Meier Curves."|Baseline to the date when 687 deaths occurred (26 January 2011)|All randomized participants.|||months|Participants|95% Confidence Interval|Median
1246779|NCT00532129|Secondary|Mean Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores|EORTC QLQ-C30: included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.|Baseline, Day 1 of Cycles 5 and 11, end of follow-up (FU) (24 month [m] FU visit, up to approximately 3 years)|FAS. Number of participants analyzed = number of participants evaluable for this outcome and n=number of participants evaluable at the specified time point.|||units on scale||Standard Deviation|Mean
1246837|NCT00531934|Secondary|Percentage of Participants Estimated to be Event Free at 12 Months|Percentage of participants estimated to be without skin rash (folliculitis) at 12 months.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population|||percentage of participants|||Number
1246838|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population|||days||95% Confidence Interval|Median
1246780|NCT00532129|Secondary|Percentage of Participants Who Achieved Minimal Residual Disease (MRD) Negativity|MRD negativity was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a confirmed CR. CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR.|||percentage of participants|||Number
1246781|NCT00532129|Secondary|Overall Survival (OS) Time|This was defined as the interval (number of days) from the trial treatment start date to the date of death by any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants||95% Confidence Interval|Median
1246782|NCT00532129|Secondary|Percentage of Participants Who Died||Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
1246783|NCT00532129|Secondary|Duration of Response (DoR)|DoR: defined as interval (in days) from first tumor response (of CR/PR/nPR) to earlier of date of PD/death. Participants without PD/death or who were lost to follow-up were censored. CR: a)Absence of LD by PE and CT, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a)≥50% decrease in Lym count from baseline value, b)≥50% reduction in LD, c)≥50% reduction in size of liver/spleen by PE/CT scan and d)Leuk, Plat and Hb ≥1.5×10^9/L, >100×10^9/L and >11.0 g/dL, respectively or 50% improvement (of all the 3) over baseline value. nPR: participants who satisfied all of CR criteria except for BM, where LN could be identified. PD: a)≥50% increase in sum of the products of ≥2 lymph nodes or appearance of new lymph nodes/extranodal lesions, or b)≥50% increase in size of HSM; new appearance of palpable HM/SM, or c)≥50% increase in number of Lym, or d)Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR, PR or nPR.|||days||95% Confidence Interval|Median
1246784|NCT00532129|Secondary|Disease Free Survival (DFS) Time|DFS time was defined as interval (in days) from first tumor response of CR to date of first tumor response of PD, or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR.|||days||95% Confidence Interval|Median
1246785|NCT00532129|Secondary|Progression Free Survival (PFS) Time|PFS was defined as the interval (in days) from trial treatment start date to earlier of the date of first tumor response assessment of PD or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||days||95% Confidence Interval|Median
1246786|NCT00532129|Secondary|Percentage of Participant With Disease Progression or Death|PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
1246793|NCT00532129|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 56 days from the beginning of the last treatment cycle that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs as well as non-serious AEs.|First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days)|FAS.|||percentage of participants|||Number
1246787|NCT00532129|Secondary|Percentage of Participants With Objective Response (CR or PR)|Objective response was defined as a tumor response of CR or PR. CR was achieved if all of the criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR was achieved if all of the criteria were met: a)≥50% decrease in Lymp count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered PRs.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants||95% Confidence Interval|Number
1246788|NCT00532129|Secondary|Percentage of Participants With BOR of Stable Disease (SD)|Participants without CR/PR or PD were considered having a tumor response of SD. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a) ≥50% decrease in Lym count from baseline, b) ≥50% reduction in LD, c) ≥50% reduction in size of liver/spleen by PE/CT and ≥1 of the following for at least 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
1246789|NCT00532129|Secondary|Percentage of Participants With BOR of Progressive Disease (PD)|PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of hepatosplenomegaly (HSM) as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
1246790|NCT00532129|Secondary|Percentage of Participants With BOR of Nodular Partial Response (nPR)|CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. Participants with nPR were those who satisfied all of the CR criteria except for the BM, where LN could be identified histologically.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
1246791|NCT00532129|Secondary|Percentage of Participants With BOR of Partial Response (PR)|PR was achieved if all of the following criteria were met: a)≥50% decrease in Lym count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered in PRs. CR was achieved if all of the criteria were fulfilled for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
1246792|NCT00532129|Secondary|Percentage of Participants With Best Overall Response (BOR) of Clinical CR or Confirmed CR|Clinical CR was achieved if all of the following criteria were met: a)Absence of lymphadenopathy (LD) by physical examination (PE) and Computed Tomography (CT) scan (all lymph nodes less than [<] 1.5 centimeters [cm] in diameter), b)No hepatomegaly (HM)/splenomegaly (SM) by PE/CT scan, c)Absence of B symptoms (unexplained fever greater than [>] 38 degrees [°] Centigrade [C], drenching night sweats/>10 percent [%] body weight loss in the last 6 months), d)Normal Complete Blood Count (CBC) (i. Leukocytes (Leuk) greater than or equal to [≥] 1.5×10^9 per liter (/L), ii. Platelets (Plat) >100×10^9/L, and iii. Haemoglobin (Hb) >11.0 grams per deciliter [g/dL]) and e)Once clinical, radiological and laboratory evaluations demonstrated CR, bone marrow (BM) biopsy and aspirate were performed 8 weeks later for confirmation; BM sample: normocellular for age, <30% of the cells being lymphocytes (Lym) and lymphoid nodules (LN) absent was considered as a confirmed CR.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
1246794|NCT00531960|Secondary|Percentage of Participants With Disease Control According to RECIST V 1.0|Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant’s 1st visit|FAS|||percentage of participants||95% Confidence Interval|Number
1246795|NCT00531960|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0|BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS|||percentage of participants||95% Confidence Interval|Number
1246796|NCT00531960|Secondary|OS|The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.|Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS; only participants who died were included in this analysis.|||months||95% Confidence Interval|Median
1246797|NCT00531960|Secondary|Percentage of Participants Who Died|Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.|Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS|||percentage of participants|||Number
1246798|NCT00531960|Primary|PFS|The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS; only participants with an event (disease progression or death) were included in the analysis.|||weeks||95% Confidence Interval|Median
1246799|NCT00531960|Primary|Percentage of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS|||percentage of participants|||Number
1246800|NCT00531947|Secondary|Hematology - Red Blood Cell (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Red Blood Cell (RBC)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks||||x10^12/L||Standard Deviation|Mean
1246801|NCT00531947|Secondary|Hematology - Hemoglobin (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks||||g/dL||Standard Deviation|Mean
1246802|NCT00531947|Secondary|Hematology - Hematocrit (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks||||percent||Standard Deviation|Mean
1246803|NCT00531947|Secondary|Hematology - White Blood Cell (WBC) (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology (Change from Baseline), by treatment assigned, is shown for the safety population. Mean change from Baseline in ABS BASOPHILS (X10^9/L), ABS EOSINOPHILS (X10^9/L), ABS LYMPHOCYTES (X10^9/L), ABS MONOCYTES (X10^9/L), and ABS NEUTROPHILS (X10^9/L) are presented.|12 Weeks||||(X10^9/L)||Standard Deviation|Mean
1246804|NCT00531947|Secondary|12 Lead ECG (Change From Baseline)Ventricular Heart Rate|A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline)Ventricular Heart Rate measured in beats per minute(beats/min or BPM), by treatment assigned, is shown for the safety population. Mean change from baseline is presented.|12 Weeks||||BPM||Standard Deviation|Mean
1246805|NCT00531947|Secondary|12 Lead ECG (Change From Baseline)|A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline) measured in milliseconds (msec), by treatment assigned, is shown for the safety population. Mean change from Baseline in PR interval, QRS duration, QT interval, and QTc (Bazett and Fridericia corrections) interval are presented.|12 Weeks||||msec||Standard Deviation|Mean
1246806|NCT00531947|Secondary|Vital Signs-Blood Pressure (Change From Baseline)|Summary mean change in blood pressure (systolic/diastolic) measured in millimeters of mercury (mmHg) (supine, standing, and orthostatic change)results for all subjects are presented.|12 Weeks||||mmHg||Standard Deviation|Mean
1246807|NCT00531947|Secondary|Vital Signs-Heart Rate (Change From Baseline)|Summary mean change in heart rate measured in beats per minute (beats/min or BPM) (supine, standing, and orthostatic change)results for all subjects are presented.|12 Weeks||||BPM||Standard Deviation|Mean
1246808|NCT00531947|Secondary|Urinalysis (Change From Baseline)|A summary of a secondary safety outcome measure, Urinalysis (Change from Baseline), by treatment assigned, is shown for the safety population. Mean changes from baseline are provided for PH and specific gravity.|12 Weeks||||units on a scale||Standard Deviation|Mean
1246809|NCT00531947|Secondary|Physical Examination (Screening vs. EOS)|Number of physical examination findings that were normal at screening, but abnormal at end of study are presented. Four subjects receiving placebo and four subjects receiving EMSAM had abnormal findings on physical examination at the end of study that were normal at screening.|12 Weeks||||Number of Abnormal Exams|||Number
1247015|NCT00530842|Secondary|Dyspnea and Leg Discomfort|Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10)|8 weeks|FAS using imputed values|||Unit on a Scale||Standard Deviation|Mean
1246810|NCT00531947|Primary|CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12|"A summary of the primary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score, as reported by the Child, at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~CDRS-R total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|baseline and 12 Weeks|Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).|||units on a scale||Standard Deviation|Mean
1246811|NCT00531947|Secondary|CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with observed cases (w/OC).~Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom area. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.~CDRS-R (Best Description) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks||||units on a scale||Standard Deviation|Mean
1246812|NCT00531947|Secondary|CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).~CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation."|12 Weeks||||units on a scale||Standard Deviation|Mean
1246813|NCT00531947|Secondary|CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)|"A summary of the secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Child), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).~CDRS-R (Child) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks||||units on a scale||Standard Deviation|Mean
1246814|NCT00531947|Secondary|CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.~CDRS-R (Best Description)total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks||||units on a scale||Standard Deviation|Mean
1246815|NCT00531947|Secondary|CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation."|Baseline and 12 Weeks||||units on a scale||Standard Deviation|Mean
1246816|NCT00531947|Secondary|CGI-C Percent Responders (mITT w/LOCF Population)|A summary of the CGI-C percent responders at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. CGI-C responders were defined as a score of 1 or 2 at the end of the study. A non-responder was defined as a score of ≥3 at end of study. Maximum score is 100%.|12 Weeks||||Percent Responder|||Number
1246817|NCT00531947|Secondary|CGI-C - Week 12 (mITT w/LOCF Population)|"A summary of the Clinicians Global Impression of Change (CGI-C) Score at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-c assesses the overall change in the severity of illness (depression). The clinician rates the subject's change based on a bipolar scale from 1(minimum; Very much improved) to 7(maximum; Very much worse). A lower score indicates lower levels of depression as compared to baseline, a higher score indicates higher levels of depression as compared to baseline. A score of 4 (Unchanged) indicates no change in illness compared to baseline. The scale is not calculated as a statistical change score; the clinician rates their impression of change overall."|12 Weeks||||units on a scale||Standard Deviation|Mean
1246818|NCT00531947|Secondary|CGI-S - Week 12 (mITT w/LOCF Population)|A summary of the Clinical Global Impression of Severity (CGI-S) at baseline and Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-s is the clinician's assessment of severity of illness (depression). Scores range from 1(minimum) to 7(maximum). A lower score indicates lower illness severity, a higher score indicates higher levels of illness severity.|Baseline and 12 Weeks|Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).|||units on a scale||Standard Deviation|Mean
1247026|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1246819|NCT00531934|Secondary|Quality of Life Score as Assessed by Visual Analog Scale (VAS)|Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint).|Baseline, Days 14 and 28, and Months 2, 3, and 4|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1246820|NCT00531934|Secondary|Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life|Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect).|Baseline, Days 14 and 28 and Months 2, 3, and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1246821|NCT00531934|Secondary|Dermatology Life Quality Index (DLQI) Global Score|Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined.|Baseline, Days 14 and 28 and Months 2, 3, and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1246822|NCT00531934|Secondary|Percentage of Participants Estimated to be Alive at 4 and 12 Months||Months 4 and 12|ITT Population|||percentage of participants|||Number
1246823|NCT00531934|Secondary|Overall Survival (OS) - Time to Event|OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||days||95% Confidence Interval|Median
1246824|NCT00531934|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||percentage of participants|||Number
1246825|NCT00531934|Secondary|Percentage of Participants Estimated to be Progression Free at 4 and 12 Months||Months 4 and 12|ITT Population|||percentage of participants|||Number
1246826|NCT00531934|Secondary|Progression-Free Survival (PFS) - Time to Event|PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||days||95% Confidence Interval|Median
1246827|NCT00531934|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||percentage of participants|||Number
1246828|NCT00531934|Secondary|Percentage of Participants by Best Global Response Under Treatment|Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||percentage of participants|||Number
1246829|NCT00531934|Secondary|Percentage of Participants With Global Disease Control by Visit|Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD).|Months 2, 4, 7, 10, and 12|ITT population; number (n) = number of participants analyzed for the specified parameter at a given visit.|||percentage of participants|||Number
1246830|NCT00531934|Secondary|Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction|Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator’s opinion.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population; only participants that discontinued or interrupted doxycycline were included in the analysis.|||percentage of participants|||Number
1246831|NCT00531934|Secondary|Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction|Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population; only participants that discontinued or interrupted erlotinib were included in the analysis.|||percentage of participants|||Number
1246832|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity|Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; only participants with an adverse event classified as other skin lesion during the first 4 months were included in the analysis.|||percentage of participants|||Number
1246839|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population|||participants|||Number
1246840|NCT00531934|Secondary|Percentage of Participants Estimated to be Event Free at 4 Months|Percentage of participants estimated to be without skin rash (folliculitis) at 4 months.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||percentage of participants|||Number
1246841|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||days||95% Confidence Interval|Median
1246842|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||participants|||Number
1246843|NCT00531934|Secondary|Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity|Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.|Months 7, 10, and 12|ITT population|||participants|||Number
1246844|NCT00531934|Secondary|Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.|Months 7, 10, and 12|ITT population|||participants|||Number
1246845|NCT00531934|Secondary|Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.|Months 7, 10, and 12|ITT population|||rash events|||Number
1246846|NCT00531934|Secondary|Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment||Months 7, 10, and 12|ITT population|||percentage of participants|||Number
1246847|NCT00531934|Secondary|Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity|Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; only participants with an adverse event of skin rash (folliculitis) during the first 4 months were included in the analysis.|||percentage of participants|||Number
1246848|NCT00531934|Secondary|Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||percentage of participants|||Number
1246849|NCT00531934|Secondary|Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||rash events|||Number
1246850|NCT00531934|Primary|Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment|Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; data for 1 participant in the erlotinib treatment group were missing.|||percentage of participants|||Number
1246851|NCT00531882|Primary|Neutrophil Delivery to the Oral Mucosa Using a Non-invasive Mouthwash Technique|Oral mucosal polymorphonuclear leukocytes (PMN) are obtained and assessed using a modification of the mouthwash method of (Wright et.al. Blood 1986;67:1023-30). For each subject, PMN counts are assessed on days 1, 2, 3 [Baseline (B)]; days 8, 9, 10 [Treatment (T)]; and days 11, 13, 15 [Recovery (R)]. The PMN counts for each subject are averaged for each study time period (B, T or R) within each study arm (Pioglitazone, Simvastatin and Ibuprofen). The mean baseline (B) PMN counts are compared to the mean treatment (T) PMN counts for each study arm, with the results expressed as the percent change in PMN counts . Paired T-tests between baseline and treatment PMN counts are used to analyze for significance. The recovery period is used to verify that the PMN counts return to baseline following the treatment period. Data from the recovery period is not shown.|3X Before treatment (Days 1,2,3) 3X During treatment (Days 8,9,10)|Healthy volunteers free of gingival disease were randomized 2:2:1 to oral Pioglitazone, Simvastatin or Ibuprofen respectively for 10 days.|||% change in mean PMN counts: B vs T|||Number
1246852|NCT00531843|Secondary|Increased Bleeding Attributed to Fondaparinux|Coagulopathic bleeding due to fondaparinux was suspected in patients requiring packed red cell transfusions after initiation of fondaparinux therapy only if the change in hematocrit prompting transfusion was not clinically commensurate with the degree of injuries that the patient had sustained (primarily orthopaedic) and/or the hematocrit did not respond appropriately post-transfusion.|3 weeks post injury||||participants|||Number
1246900|NCT00531518|Primary|Psychotic Symptoms|Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.|two years||||units on a scale||Standard Deviation|Mean
1246853|NCT00531843|Primary|Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE)|Color-flow duplex venous ultrasonography examinations of upper and lower extremities were performed within 48 hours of injury, and then weekly until discharge or 3 weeks. DVT was defined as any clot occurring in the subclavian, iliac, femoral, or popliteal location. Patients were examined daily for clinical signs and symptoms of venous thromboembolism (VTE) and PE. Small, nonocclusive clots discovered in other locations were observed for progression on sequential ultrasonography examinations.|within 3 weeks post injury|Of 11 patients with initial contraindication to anticoagulation, 5 were cleared by the treating physicians to receive fondaparinux within 3 days of injury, and 6 were not.|||participants|||Number
1246854|NCT00531843|Secondary|Normal Trough and Peak Fondaparinux Concentration|Serum samples were collected 30 minutes before (trough) and 2 hours after (peak) the third dose of fondaparinux. Normative data plots comparing study participants with healthy volunteers were supplied by the company outsourced to analyze samples.|Day 3|Serum samples were obtained from 63 representative patients from our study who received Fondaparinux and compared against normative values from normal volunteers supplied by our sponsor.|||Participants|||Number
1246855|NCT00531817|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Days 3 and 7|Serum concentration of CRP (high-sensitivity CRP [hsCRP] test) was analyzed by a central laboratory.|Baseline to Days 3 and 7|C-reactive protein (CRP) population: A subset of patients enrolled at designated study sites who met the CRP entry criteria (CRP ≥ 1 mg/dL), received at least 1 dose of study medication, and attended the Day 3 or Day 7 visit. No imputation of missing data was made; only observed data are reported.|||mg/dL||Standard Deviation|Mean
1246856|NCT00531817|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Day 7|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Day 7|C-reactive protein (CRP) population: A subset of patients enrolled at designated study sites who met the CRP entry criteria (CRP ≥ 1 mg/dL), received at least 1 dose of study medication, and attended the Day 3 or Day 7 visit. LOCF was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.|||Percentage of participants|||Number
1246857|NCT00531817|Secondary|Mean Change From Baseline in Individual Components of the Routine Assessment Patient Index Data (RAPID) at Each Day During the First 7 Days of Treatment|Derived from the Multidimensional Health Assessment Questionnaire (MDHAQ), the RAPID includes 3 domains that assess disease activity in rheumatoid arthritis: A physical function score (0-10), a pain visual analog scale score (VAS, 0-100), and a global assessment of disease activity VAS score (0-100). Each domain was assessed with the Patient Take Home Form (PTHF). Higher scores indicate more disease activity. A negative change score indicates improvement.|Baseline through Day 7|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
1246858|NCT00531817|Secondary|Mean Change From Baseline in the Medical Outcomes Study (MOS) Sleep Scale Score at Weeks 4, 8, 12, 16, 20, and 24|The MOS Sleep Scale is a 12-item patient self-report instrument that assesses the quality and quantity of sleep over the previous 4 weeks. A sleep problems index (SLP9) was generated using 9 of the 12 items (1, 3, 4, 5, 6, 7, 8, 9, 12). Each item was normalized so that the lowest and highest possible scores were set to 0 and 100, respectively. The SLP9 score is the average of the recoded 9 items. The SLP9 score ranged from 0 to 100. Higher scores represent greater sleep problems. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
1246859|NCT00531817|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 4, 8, 12, 16, 20, and 24|The FACIT-F is a 13-item patient self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
1246860|NCT00531817|Secondary|Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24|The SF-12 is a self-report measure of general health status with 1 or 2 items for each of 8 domains: Physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Two component summaries, physical (PCS-12) and mental (MCS-12) were calculated using norm-based scoring, resulting in means of 50 and standard deviations of 10 in the 1998 general United States population. Higher scores represent better health and a positive change from baseline represents improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
1246870|NCT00531752|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose).|Baseline up to 1 week after last study dose|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1246861|NCT00531817|Secondary|Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24|Derived from the Multidimensional Health Assessment Questionnaire (MDHAQ), the RAPID includes 3 domains that assess disease activity in rheumatoid arthritis: A physical function score (MDHAQ items 1a-j), a pain visual analog scale score (VAS, item 2 in the MDHAQ), and a global assessment of disease activity VAS score (item 6 in the MDHAQ). Each domain is scored on a scale of 0-10. The RAPID score is the sum of the 3 domain scores divided by 3 resulting in a total score on a scale of 0-10. Higher scores indicate more disease activity and a negative change from baseline indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
1246862|NCT00531817|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24|Change of the DAS28 score from baseline was used to determine the EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. Missing data was imputed as “no response”.|||Percentage of participants|||Number
1246863|NCT00531817|Secondary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24|DAS28 was calculated using the following formula: 0.56 × sqrt(TJC) + 0.28 × sqrt(SJC) + 0.70 × ln(ESR) + 0.014 × GH, where TJC = tender joint count on 28 joints, SJC = swollen joint count on 28 joints, ESR = erythrocyte sedimentation rate at the current visit (mm/hr), and GH = general health, ie, the patient’s global assessment of disease activity (DA) in the previous 24 hours on a 100 mm visual analog scale (no DA to maximum DA). The DAS28 score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
1246864|NCT00531817|Primary|Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Week 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. In determining ACR status, a last observation carried forward (LOCF) approach was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.|||Percentage of participants|||Number
1246865|NCT00531817|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. In determining ACR status, a last observation carried forward (LOCF) approach was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.|||Percentage of participants|||Number
1246866|NCT00531752|Other Pre-specified|Treatment Duration|Treatment duration was defined as the total number of dosing days from first to last day of study drug administration in each period.|Day 1 up to Day 21|Safety analysis set consisted of all participants who took at least 1 dose of study medication.|||days||Full Range|Mean
1246867|NCT00531752|Other Pre-specified|Number of Participants With Change From Baseline in Physical Examination and Neurological Examination|Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal system.|Baseline up to 1 week after last study dose (1 week after end of Period 2)|Safety analysis set consisted of all participants who took at least 1 dose of study medication.|||participants|||Number
1246868|NCT00531752|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for potential clinical concern in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or >120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum increase from baseline in systolic BP >=30 mmHg, maximum increase from baseline in diastolic BP >=20 mmHg.|Baseline up to 1 week after last study dose|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1246869|NCT00531752|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum QTc interval of 450 to <480 msec, 480 to <500 msec and >=500 msec.|Baseline up to End of Treatment (Week 3 of period 2)|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1246871|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246872|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Total WASO subscale score ranges from 0 to 24 hours. Lower value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||hours||Standard Deviation|Mean
1246873|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Number of awakenings subscale score ranges from 0 to 30. Lower value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||awakenings||Standard Deviation|Mean
1246874|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||hours||Standard Deviation|Mean
1246875|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3|SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total awake after sleep onset (WASO [1 item]), quality of sleep (1 item). Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||minutes||Standard Deviation|Mean
1246876|NCT00531752|Other Pre-specified|Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep, and overall sleep problem index (SPI) I (range 0 to 600) and II. Except for sleep quantity and sleep problem index I, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246877|NCT00531752|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3|SDS was a participant-rated questionnaire assessing the effect of the participant's symptoms on the 3 domains/subscales: work/school, social life/leisure activities, and family/home management. Each domain was rated on visual analog scale ranges from 0 to 10 where 0=not at all impaired and 10=extremely impaired, and total SDS score was calculated as a sum of all the domains with a score range of 0=not at all impaired to 30=extremely impaired. Disability scores were reported for each of the domains/subscales. Higher scores reflect greater impairment.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for given subscale at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246878|NCT00531752|Secondary|Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3|AAQoL is a 29-item questionnaire consisting of 4 subscales: life productivity (11 items), psychological health ([PH] 6 items), life outlook (7 items) and relationships (5 items). Participants rated each item on a scale ranging from 1 (not at all/never) to 5 (extremely/very often). The scores of each item were then transformed to a 0 to 100 point scale, higher scores indicating better quality of life. The score for each subscale was calculated as the sum of the corresponding item scores. Total score ranges were: life productivity (0 to 1100), psychological health (0 to 600), life outlook (0 to 700) and relationships (0 to 500), where higher subscale score indicates better quality of life for each subscale.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246944|NCT00531206|Secondary|Subjective Well-being|Investigator’s opinion of patient’s general condition (quality of life)|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||participants|||Number
1246879|NCT00531752|Secondary|Change From Baseline in ADHD Impact Module – Adults (AIM-A) Subscale Score at Week 3|AIM-A: 66 item questionnaire completed by the participant to assess the impact of ADHD on the participant’s quality of life. It is comprised of 4 global quality of life (QoL) items (current quality of life item [CQoLI], range:1 to 10; global limitation item [GLI]: range:1 to 4, on the right track item [RTI], range:1 to 3, more good days [GD] than bad days [BD], range:1 to 5, higher scores indicate a better QoL for all the 4 QoL items) and 6 multi-item subscales (living with ADHD, general well-being, performance and daily functioning [PDF], relationships and communication [R/C], Impact of symptoms-bother/concern [IS-B/C] scale, and impact of symptoms-interference [IS-I] scale). Participants responded to each item of multi-item subscale using a likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Multi-item subscale scores were calculated as an average of scores for the contributing items and transformed into 0 to 100 score where higher scores indicate a better QoL.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246880|NCT00531752|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3|HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item was scored on a scale ranging from 0 (not present) to 4 (very severe) with a total score range of 0 to 56, where higher score indicates greater anxiety.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246881|NCT00531752|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3|The MADRS scale measures the depression level of a participant. It is administered as a semi-structured clinician interview. The total score is derived by adding the scores of the following 10 items: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts. Each item is scored using a 6-point scale which ranges from 0 to 6 (a higher score indicates increased severity). The total score range was 0 to 60 where 0 indicates no depression and 60 indicates severely depressed.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246882|NCT00531752|Secondary|Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21|TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponded to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period.|Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21|Analysis population included all participants in PP analysis set and 1 additional participant in PF-03654746 (Flexible Dose) for whom the post-baseline data was available.‘N’ (number of participants analyzed)=evaluable participants for this measure and ‘n’= evaluable participants for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246883|NCT00531752|Secondary|Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). The AISRS inattention and hyperactive/impulsive total subscale score range from 0 to 27. A higher total subscale score corresponded to a worse severity of ADHD inattention or hyperactivity/impulsivity.|Baseline, Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246884|NCT00531752|Secondary|Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score|TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponds to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period. Participants with sustained response were those who had at least 30 percent decrease from baseline in TASS total score, which was maintained at all visits up to the time of assessment. Sustained responders at Day 7, 14 and 21 were analyzed.|Day 7, 14, 21|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||percentage of participants|||Number
1246898|NCT00531661|Primary|Freedom From a Device/System-related Complication (DSRC).|"A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:~is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)~results in the death of the subject~results in the explant of the device"|6 months|This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device as well as patients where an implant was attempted. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC). This population includes 550 implanted patients + 25 patient attempts.|||cases|Participants||Number
1246885|NCT00531752|Secondary|Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||percentage of participants|||Number
1246886|NCT00531752|Secondary|Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Participants with a score of 1 (normal - not ill at all) or 2 (borderline mentally ill) are reported.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||percentage of participants|||Number
1246887|NCT00531752|Secondary|Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||percentage of participants|||Number
1246888|NCT00531752|Secondary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline, Week 1, 2|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1246889|NCT00531752|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline, Week 3|Per Protocol (PP) set: all participants included in full analysis set (FAS=who received at least[>=]1 dose of randomized study drug,had baseline and >=1 post-baseline measurement of primary efficacy variable)and had no major protocol violation affecting primary efficacy variable. n=participants evaluable at specified time points for each arm.|||units on a scale||Standard Deviation|Mean
1246890|NCT00531661|Other Pre-specified|Freedom From Pressure Sensor Failure||Study duration: average patient follow-up of 15 months||||participants|||Number
1246891|NCT00531661|Other Pre-specified|Freedom From a Device/System-related Complication (DSRC)||Study duration: average patient follow-up of 15 months||||participants|||Number
1246892|NCT00531661|Other Pre-specified|Rate of HFR Hospitalizations||Study duration: average patient follow-up of 15 months||||HFR hospitalizations/patient-year|||Number
1246893|NCT00531661|Secondary|Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)|THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual’s quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.|6 months||||units on a scale||Standard Deviation|Mean
1246894|NCT00531661|Secondary|Days Alive Outside of the Hospital||6 months||||days||Standard Deviation|Mean
1246895|NCT00531661|Secondary|Proportion of Patients Hospitalized for Heart Failure||6 months||||participants|||Number
1246896|NCT00531661|Secondary|Change From Baseline in Pulmonary Artery Mean Pressure|Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.|6 months||||mmHg * days||Standard Deviation|Mean
1246897|NCT00531661|Primary|Freedom From Pressure Sensor Failure|A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.|6 months|This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC).|||participants|||Number
1246899|NCT00531661|Primary|Rate of Heart Failure Related (HFR) Hospitalizations||6 months||||HFR hospitalizations/patient/6 months|||Number
1246901|NCT00531479|Secondary|Time to Death Due to Invasive Aspergillosis (IA)|Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N = number of participants in MITT population at time of assessment. Participants who died due to causes other than IA were defined as censored at time of death.|||days||Full Range|Median
1246902|NCT00531479|Secondary|Time to Death: All-Cause Mortality|Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N = number of participants in MITT population at time of assessment.|||days||Full Range|Median
1246903|NCT00531479|Secondary|Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA|Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|MITT; N = number of participants in MITT population at Week 6. Participants who died due to causes other than IA before Week 6 were censored at their time of death in this analysis.|||participants|||Number
1246904|NCT00531479|Secondary|All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)|Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N=number of participants in MITT population at Week 12.|||participants|||Number
1246905|NCT00531479|Secondary|All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)|Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|Intent-to-treat (ITT) population: participants in MITT analysis set plus participants with possible IA who could not be upgraded to probable or proven IA within 7 days and had received at least 1 dose of study medication. N=number of participants in ITT population at Week 6.|||participants|||Number
1246906|NCT00531479|Secondary|Global Response at Week 6|Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and >90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and >50% improvement in radiological findings present at BL.|Baseline, Day 42 (Week 6)|MITT; N = number of participants in MITT population at Week 6. Missing data and participants who died at Week 6 were treated as failure.|||participants|||Number
1246907|NCT00531479|Primary|All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis|Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|Modified intent-to-treat (MITT) population: all randomized participants with proven or probable IA confirmed by Day 7 following enrollment who received at least 1 dose of study medication. N=number of participants in MITT population at Week 6. Participants not known to have died were censored at last study visit (Day 84).|||participants|||Number
1246908|NCT00531453|Secondary|Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)|"Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow."|all data included in clinical database as of 10 April 2009|The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-transplantation response assessment. The response-evaluable population comprises 38 subjects in the VDT treatment group and 27 subjects in the VDTC group.|||percentage of participants|||Number
1246909|NCT00531453|Primary|Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction|"Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow."|all data included in clinical database as of 10 April 2009|The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-baseline response assessment. The response-evaluable population comprises 49 subjects in the VDT treatment group and 48 subjects in the VDTC group.|||percentage of participants|||Number
1246910|NCT00531427|Secondary|Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.|The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12 of the double-bind phase|Full Analysis Population (N = 570) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1246911|NCT00531427|Secondary|Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.|Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).|10 weeks|Subjects in the full analysis population who took at least 1 dose of supplemental analgesic medication.|||tablets||Standard Deviation|Mean
1246912|NCT00531427|Primary|"Average Pain Over the Last 24 Hours Score of the Study Knee at Week 12 of the Double Blind Phase."|"Average pain over the last 24 hours” scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily."|24 hours (week 12)|The full analysis population is the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale||Standard Deviation|Mean
1246913|NCT00531284|Secondary|Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||hours||Standard Deviation|Mean
1246914|NCT00531284|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||liters||Standard Deviation|Mean
1246915|NCT00531284|Secondary|Clearance (CL) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||liters/hour||Standard Deviation|Mean
1246916|NCT00531284|Secondary|Elimination Half-life (t½) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||hours||Full Range|Median
1246917|NCT00531284|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1246918|NCT00531284|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1246919|NCT00531284|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||hours||Full Range|Median
1246920|NCT00531284|Secondary|Maximum Observed Plasma Concentration of Carfilzomib|Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.|Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1246921|NCT00531284|Secondary|Time to Progression|Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety population.|||months||95% Confidence Interval|Median
1246922|NCT00531284|Secondary|Progression-Free Survival|Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety population|||months||95% Confidence Interval|Median
1246923|NCT00531284|Secondary|Duration of Response|Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety Population with a partial response or better|||months||95% Confidence Interval|Median
1246945|NCT00531206|Secondary|CD4+ Cell Count|Change from baseline in CD4+ count over time|Baseline and 52 weeks|Full Analysis Set (FAS), all patients entered and treated|||cells/mm3||Inter-Quartile Range|Median
1246946|NCT00531206|Secondary|Change in Viral Load|Log10 change from baseline in viral load over time|Baseline and 52 weeks|Full Analysis Set (FAS), all patients entered and treated|||log10 copies/ml||Inter-Quartile Range|Median
1246947|NCT00531206|Primary|Adverse Events|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients with adverse events|||Number
1246924|NCT00531284|Secondary|Percentage of Participants With an Overall Response Throughout the Study|"Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM.~Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR."|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety Population|||percentage of participants||95% Confidence Interval|Number
1246925|NCT00531284|Primary|Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles|"Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.~CR: Disappearance of all target and non-target lesions and no new lesions;~PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions."|4 months|Phase 2 Safety population|||percentage of participants||95% Confidence Interval|Number
1246926|NCT00531284|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)|"Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.~A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding.~The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which < 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle."|28 days|Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT.|||participants|||Number
1246927|NCT00531206|Secondary|Alkaline Phosphatase Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||international units/liter||Inter-Quartile Range|Median
1246928|NCT00531206|Secondary|Total Bilirubin Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
1246929|NCT00531206|Secondary|Creatinine Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
1246930|NCT00531206|Secondary|Gamma-glutamyl Transpeptidase (GGT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||international units/liter||Inter-Quartile Range|Median
1246931|NCT00531206|Secondary|Aspartate Aminotransferase (ALT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||international units/liter||Inter-Quartile Range|Median
1246932|NCT00531206|Secondary|Alanine Aminotransferase (ALT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||international units/liter||Inter-Quartile Range|Median
1246933|NCT00531206|Secondary|Triglycerides Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
1246934|NCT00531206|Secondary|Low Density Lipoprotein (HDL) Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
1246935|NCT00531206|Secondary|High Density Lipoprotein (HDL) Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
1246936|NCT00531206|Secondary|Total Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
1246937|NCT00531206|Secondary|Body Mass Index Class (Kilograms/Square Meter)||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||participants|||Number
1246938|NCT00531206|Secondary|Use of Lipid Lowering Agents During the Study||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||participants|||Number
1246939|NCT00531206|Secondary|Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||participants|||Number
1246940|NCT00531206|Secondary|Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients|||Number
1246941|NCT00531206|Secondary|Discontinuations Due to an Adverse Event|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients|||Number
1246942|NCT00531206|Secondary|Deaths|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients|||Number
1246943|NCT00531206|Secondary|Serious Adverse Events|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients|||Number
1246948|NCT00531050|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hours 30 minutes and 24 hours post morning dose FEV1 measurements. Analysis of covariance included pre-dose FEV1 as covariate.|23 hours 30 minutes and 24 hours post-dose at Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization.|||Liters||95% Confidence Interval|Least Squares Mean
1246949|NCT00531050|Primary|Maximum Heart Rate (HR) During Salbutamol Administration in Part 2|Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.|24 hours post dose on Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate.|||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
1246950|NCT00531050|Primary|Maximum Heart Rate During Exercise in Part 1|Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.|2 hour post-dose on Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization.|||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
1246951|NCT00531050|Primary|Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study|"The percentage of patients with an increase of >= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined.~0-12 hours: post first dose measurements up to second dose~12-24 hours: post second dose measurement up to and including the 24 hour measurement~0-24 hours: all post dose measurements up to and including the 24 hour measurement"|24 hours post dose on Day 1|Safety population. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate. In a patient where data for the second 12 hour period is missing, 0-24 is not reported; hence the discrepancy of 4 and 3 subjects.|||Percentage of participants||95% Confidence Interval|Number
1246952|NCT00531050|Secondary|Change in Heart Rate During Exercise in Part 1|"Change in heart rate is calculated from the 1.5 hour post dose to the maximum heart rate during exercise.~Analysis of covariance included treatment and period as fixed effects, subject as random effect and 1.5 hour pre-exercise/post dose heart rate as a covariate."|1.5 hour post dose to max heart rate during exercise|The safety population consisted of all subjects who received at least one dose of study medication after randomization.|||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
1246953|NCT00531050|Primary|Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study|The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.|24-hours post-dose on Day 1 (of each treatment)|The safety population consisted of all subjects who received at least one dose of study medication after randomization.|||Percentage of participants||95% Confidence Interval|Number
1246954|NCT00531011|Primary|In-stent Late Loss (LL)|Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.|at 270 days|Descriptive statistics for this measure are based on one random lesion per patient, 167 patients performed angiographic follow-up.|||millimeters|Participants|Standard Deviation|Mean
1246955|NCT00531011|Secondary|Distal Minimum Lumen Diameter (MLD).|Distal refers to the immediate 5 mm outside of the distal end of the stent.|at 9 months.||||millimeters|Participants|Standard Deviation|Mean
1246956|NCT00531011|Secondary|Proximal Minimum Lumen Diameter (MLD).|Proximal refers to the immediate 5 mm outside of the proximal end of the stent.|at 9 months.||||millimeters|Participants|Standard Deviation|Mean
1246957|NCT00531011|Secondary|In-segment Minimum Lumen Diameter (MLD).||at 9 months.||||millimeters|Participants|Standard Deviation|Mean
1246958|NCT00531011|Secondary|In-stent Minimum Lumen Diameter (MLD).||at 9 months.||||millimeters|Participants|Standard Deviation|Mean
1246959|NCT00531011|Secondary|Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.||9 months|ITT|||percentage of participants|||Number
1246960|NCT00531011|Secondary|Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .|ITT|9 months|ITT|||percentage of participants|||Number
1246961|NCT00531011|Secondary|Revascularizations|(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.|9 months|ITT|||percentage of participants|||Number
1246962|NCT00531011|Secondary|Revascularizations|(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.|at 30 days|ITT|||percentage of participants|||Number
1246963|NCT00531011|Secondary|Adjudicated Stent Thrombosis.||9 months|ITT|||percentage of participants|||Number
1246964|NCT00531011|Secondary|Adjudicated Stent Thrombosis.||at 30 days||||percentage of participants|||Number
1246965|NCT00531011|Secondary|Device Success|defined as achievement of a final residual in-stent diameter stenosis of < 30% (visual assessment) using the assigned device only.|at the time of PCI||||percentage of participants|Participants||Number
1246966|NCT00531011|Secondary|Procedural Success|defined as: residual in-stent %DS of < 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.|at the time of PCI||||percentage of participants|Participants||Number
1246967|NCT00531011|Secondary|Lesion Success|defined as attainment of < 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.|at the time of PCI|Intent to treat (ITT)|||Percentage of participants|Participants||Number
1246969|NCT00531011|Secondary|Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .|This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.|at 30 days|ITT|||percentage of participants|||Number
1246970|NCT00531011|Secondary|In-segment Late Loss (LL)|LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.|at 9 months|167 patients performed angiographic follow-up. Descriptive statistics for this measure are based on one random lesion per patient.|||millimeters|Participants|Standard Deviation|Mean
1246971|NCT00531011|Secondary|In-segment Binary Restenosis Rate|"This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges~In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent."|at 9 months|167 patients performed angiographic follow-up.|||percentage of participants|Participants||Number
1246972|NCT00531011|Secondary|In-stent Binary Restenosis Rate|This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges.|at 9 months|ITT, 167 patients performed angiographic follow-up.|||percentage of participants|Participants||Number
1246973|NCT00530946|Secondary|Change in Apolipoprotein B From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases|||mg/dL||Standard Deviation|Mean
1246974|NCT00530946|Secondary|Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Ratio||Standard Deviation|Mean
1246975|NCT00530946|Secondary|Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases|||Ratio||Standard Deviation|Mean
1246976|NCT00530946|Secondary|Percent Change in Triglycerides From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Percent Change||Standard Deviation|Mean
1246977|NCT00530946|Secondary|Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Percent Change||Standard Deviation|Mean
1246978|NCT00530946|Secondary|Percent Change in Total Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Percent Change||Standard Deviation|Mean
1246979|NCT00530946|Secondary|Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Percent Change||Standard Deviation|Mean
1246980|NCT00530946|Secondary|Change in Diastolic Blood Pressure From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||mm Hg||Standard Deviation|Mean
1246981|NCT00530946|Secondary|Change in Systolic Blood Pressure From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases|||mm Hg||Standard Deviation|Mean
1246982|NCT00530946|Primary|Percent Change in Low Density Lipoprotein-Cholesterol|"Percent of value at Week 8 minus value at baseline over value at baseline"|8 weeks|Full Analysis Set, Last Observation Carried Forward|||Percent Change||Standard Error|Least Squares Mean
1246983|NCT00530946|Primary|Change in Systolic Blood Pressure|Value at Week 8 minus value at baseline|8 weeks|Full Analysis Set, Last Observation Carried Forward|||mm Hg||Standard Error|Least Squares Mean
1246984|NCT00530920|Secondary|Clinical Abnormal Findings in Laboratory and Physical Examination||Screening through the end of the study (14 days)|Treated set.|||participants|||Number
1246985|NCT00530920|Secondary|Cmax of Ritonavir|Ritonavir pharmacokinetics|Visits baseline, 5, 7, 9 and 13 or 14|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
1246986|NCT00530920|Secondary|Tmax of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h||Geometric Coefficient of Variation|Geometric Mean
1246987|NCT00530920|Secondary|Terminal Half-Life (t1/2) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||Hours||Geometric Coefficient of Variation|Geometric Mean
1246988|NCT00530920|Secondary|Volume of Distribution (V/F) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||L||Geometric Coefficient of Variation|Geometric Mean
1246989|NCT00530920|Secondary|Apparent Oral Clearance I(Cl/F) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||L/h||Geometric Coefficient of Variation|Geometric Mean
1246990|NCT00530920|Secondary|Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
1246991|NCT00530920|Secondary|AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h*uM||Geometric Coefficient of Variation|Geometric Mean
1246996|NCT00530920|Secondary|Trough Concentration (Cmin) of Tipranavir|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
1246997|NCT00530920|Secondary|Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
1246998|NCT00530920|Secondary|Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)|Tipranavir (TPV) pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h*uM||Geometric Coefficient of Variation|Geometric Mean
1246999|NCT00530920|Secondary|Apparent Oral Clearance I(Cl/F) of Tipranavir|"Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu­lar models the fraction of dose absorbed cannot be estimated, therefore clear­ance for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed."|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||L/h||Geometric Coefficient of Variation|Geometric Mean
1247000|NCT00530920|Primary|Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))||Baseline (Day 0) to Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||Log10 copies/mL||Inter-Quartile Range|Median
1247001|NCT00530894|Secondary|Change in Quality of Life (QOL) From Baseline to 1 Year|"The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.~KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.~SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status."|Baseline and 1 Year|Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.|||Units on a scale||Standard Deviation|Mean
1247002|NCT00530894|Secondary|Total Hospital Days From the Index Procedure|Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.|1 year||||Days||Standard Deviation|Mean
1247003|NCT00530894|Secondary|Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)|Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure|1 year||||participants|||Number
1247004|NCT00530894|Secondary|Functional Change of NYHA|NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.|Baseline to 1 year|Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.|||Units on scale||95% Confidence Interval|Least Squares Mean
1247005|NCT00530894|Primary|Composite of Death and Recurrence Hospitalization.|Death from any cause or repeat hospitalization after intervention.|duration of study|Composite of Death and recurrence hospitalization was not a primary outcome for the High Risk groups.|||participants|||Number
1247006|NCT00530894|Primary|Death|Death from any cause.|1 Year||||participants|||Number
1247007|NCT00530855|Secondary|Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study||From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.|||Participants|||Number
1247008|NCT00530855|Secondary|Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design)."|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.|||Participants|||Number
1247009|NCT00530855|Primary|Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study|Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.|||days||Standard Deviation|Mean
1247010|NCT00530855|Primary|Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study|Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.|||Participants|||Number
1247011|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none)|8 weeks|FAS using imputed values|||Participants|||Number
1247012|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none)|4 weeks|FAS using imputed values|||Participants|||Number
1247013|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none)|baseline|FAS using imputed values|||Participants|||Number
1247028|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Percent of predicted FEV1||Standard Error|Mean
1247029|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Percent of predicted FEV1||Standard Error|Mean
1247030|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Percent of predicted FEV1||Standard Error|Mean
1247031|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Percent of predicted FEV1||Standard Error|Mean
1247032|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247033|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247034|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247035|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247036|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247037|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247038|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247039|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247040|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Percent of TGV over TLC||Standard Error|Mean
1247041|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Percent of TGV over TLC||Standard Error|Mean
1247042|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Percent of TGV over TLC||Standard Error|Mean
1247043|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Percent of TGV over TLC||Standard Error|Mean
1247044|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Percent of RV over TLC||Standard Error|Mean
1247045|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Percent of RV over TLC||Standard Error|Mean
1247046|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Percent of RV over TLC||Standard Error|Mean
1247047|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Percent of RV over TLC||Standard Error|Mean
1247048|NCT00530842|Secondary|Static Lung Volumes|Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247049|NCT00530842|Secondary|Static Lung Volumes|Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247050|NCT00530842|Secondary|Static Lung Volumes|Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247051|NCT00530842|Secondary|Static Lung Volumes|Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247052|NCT00530842|Secondary|Static Lung Volumes|Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247053|NCT00530842|Secondary|Static Lung Volumes|Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247054|NCT00530842|Secondary|Static Lung Volumes|Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247055|NCT00530842|Secondary|Static Lung Volumes|Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247056|NCT00530842|Secondary|Static Lung Volumes|Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247057|NCT00530842|Secondary|Static Lung Volumes|Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247058|NCT00530842|Secondary|Static Lung Volumes|Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247066|NCT00530842|Secondary|Endurance Time (After 4 Weeks)|Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)|4 weeks|FAS using imputed values|||Seconds||Inter-Quartile Range|Median
1247067|NCT00530842|Secondary|Post-dose TGV(FRC) (After 4 Weeks)|Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1247068|NCT00530842|Primary|Endurance Time (After 8 Weeks)|Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)|8 weeks|FAS using imputed values|||Seconds||Inter-Quartile Range|Median
1247069|NCT00530842|Primary|Post-dose TGV(FRC) (After 8 Weeks)|Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks|8 weeks|FAS using imputed values. The full analysis set (FAS) was defined to include all treated patients with any post-dosing efficacy data after at least 4 weeks for both investigational treatments in TGV(FRC) or endurance time.|||Litres||Standard Error|Mean
1247070|NCT00530816|Secondary|Overall Survival (OS)|"Overall Survival is defined as the time from the start of study treatment to date of death due to any cause.~Patients who were alive or lost to follow-up as of the data analysis cut-off date for the final OS analysis were censored at the date the patient was last known to be alive. Median OS was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 19 November 2012 for Part 1 and 07 January 2013 for Part 2. Median follow-up time was 19.1 months for Part 1 and 35.9 months in Part 2.|Safety Population includes all patients enrolled on study and who received at least 1 dose of carfilzomib.|||months||95% Confidence Interval|Median
1247071|NCT00530816|Secondary|Progression-free Survival (PFS)|"Progression-free Survival (PFS) is defined as the time from start of treatment to IRC determined disease progression or death due to any cause. Patients who were lost to follow-up prior to documentation of disease progression and patients who were alive without disease progression before a data analysis cut-off date were censored at the last disease assessment.~Median PFS was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.|Response Evaluable Population|||months||95% Confidence Interval|Median
1247072|NCT00530816|Secondary|Time to Progression (TTP)|"Time to Progression is defined as the time from the start of treatment to IRC-determined disease progression. Patients who were lost to follow-up prior to documentation of disease progression, or who died before documentation of disease progression or who were alive and did not have documentation of disease progression before the data analysis cut-off date were censored at the last disease assessment.~Median TTP was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.|Response Evaluable Population|||months||95% Confidence Interval|Median
1247073|NCT00530816|Secondary|Duration of Response (DOR)|"DOR is defined as the time from first evidence of PR or better to disease progression assessed by the IRC or death due to any cause. Patients lost to follow-up prior to disease progression or who were alive without disease progression before the analysis cutoff date were censored at the last disease assessment.~Progressive disease was defined as any of the following:~An increase of M-protein in serum (absolute increase ≥ 0.5 g/dL) or urine (absolute increase ≥ 200 mg/24 hours) of > 25% from the nadir (if not zero).~Percentage of plasma cells in bone marrow ≥ 10%.~New or increased size of bone lesions or new plasmacytomas.~Patients without measurable serum and urine M-protein: 25% increase from nadir in the difference between involved and uninvolved FLC levels and absolute increase >10 mg/dL.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) attributed solely to the proliferative disorder.~Median DOR was estimated using Kaplan-Meier methods."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2.|Response Evaluable Population with a response of PR or better.|||months||95% Confidence Interval|Median
1247074|NCT00530816|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate is defined as the percentage of participants with a best overall response of minimal response (MR) or better, i.e., a best overall response of sCR, CR, VGPR, PR, or MR. MR was defined as outlined by European Group for Blood and Marrow Transplantation (EBMT) criteria, defined as reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89%, maintained for 6 weeks.|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|Response Evaluable Population|||percentage of participants||95% Confidence Interval|Median
1247075|NCT00530816|Secondary|Best Overall Response Rate (ORR) in the Response Evaluable Population|"ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy.~sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.~CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow.~VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level < 100 mg/24 hours.~PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to < 200 mg per 24 hours."|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, End of Study, 30 days after last dose; median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|The Response Evaluable population consists of all treated patients with measurable disease at Baseline as assessed by M-protein, SFLC or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1247100|NCT00530777|Primary|Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation|Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation|4 weeks|Women with paired plasma samples at 34 and 38 weeks gestation|||log10 copies/mL||Standard Deviation|Mean
1247076|NCT00530816|Primary|Best Overall Response Rate (ORR) in the Response Evaluable Subset Population|"ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy.~sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.~CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow.~VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level < 100 mg/24 hours.~PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to < 200 mg per 24 hours."|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|"The Response Evaluable Subset population consists of all treated patients with measurable disease at Baseline as assessed by M-protein or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment.~Patients whose disease was only measurable by SFLC were excluded."|||percentage of participants||95% Confidence Interval|Number
1247077|NCT00530803|Secondary|Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS|The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain participants were experiencing 5 minutes after the venipuncture was completed. Total number of participants subjectively evaluated as experiencing each pain level is reported.|5 minutes post venipuncture||||Participants|||Count of Participants
1247078|NCT00530803|Secondary|Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS|The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at needle insertion. Total number of participants subjectively evaluated as experiencing each pain level is reported.|during needle insertion||||Participants|||Count of Participants
1247079|NCT00530803|Secondary|Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS|The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at tourniquet placement. Total number of participants subjectively evaluated as experiencing each pain level is reported.|before venipuncture||||Participants|||Count of Participants
1247080|NCT00530803|Secondary|Parent Rating of Child's Pain Using a 6-point NRS|The Numerical Rating Scale (NRS) is a 6-point rating scale where 0= no pain and 5 = worst pain. Parents reported their own subjective evaluation of participants pain level. Each participant had only one parental assessment. Total number of parental assessment for each pain level on the 6-point NRS is reported as total number of participants experiencing that pain level.|immediately after venipuncture is completed|Number of parent assessment for each pain level on the 6-point NRS. Each participant had only one parental assessment.|||Participants|||Count of Participants
1247081|NCT00530803|Primary|Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.|Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, “no pain,” to 5, “the most pain you can have.” The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5.|immediately after completion of venipuncture||||Participants|||Count of Participants
1247082|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1-12|PK Population|||picograms/mL||Standard Deviation|Mean
1247083|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1 -12|PK Population|||picograms/mL||Standard Deviation|Mean
1247084|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1-12|Pharmacokinetic (PK) Population: subjects who underwent blood sampling for measuring the trough plasma drug concentrations, excluding those who did not fulfill inclusion criteria, those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.|||picograms/mL||Standard Deviation|Mean
1247085|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)|"Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety 0-21 and seven for depression 0-21. Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation."|Baseline - Week 12/EW|FAS: Subpopulation: HADS Anxiety population, N = 15; HADS Depression population, N = 31. Patients in the FAS population who also have a baseline anxiety domain score of 8 or greater and patients with a baseline depression domain score of 8 or greater will be included in the HADS Anxiety Population and the HADS Depression Population, respectively.|||Points on a scale||Standard Deviation|Mean
1247115|NCT00530712|Secondary|Increase in Ankle-Brachial Index|Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.|1 Year||||Ratio||Standard Deviation|Mean
1247086|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)|"The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from Not at all (0) to Extremely (4). The assessment measures six identified mood factors:~Tension-Anxiety~Depression-Dejection~Anger-Hostility~Vigor-Activity~Fatigue-Inertia~Confusion-Bewilderment"|Baseline and Week 12/EW|Full Analysis Set|||Points on a scale||Standard Deviation|Mean
1247087|NCT00530790|Primary|Vital Signs and Body Weight Change From Baseline|Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.|Baseline to Week 12/EW|Safety Population|||Varied Standard Units of Measure||Standard Deviation|Mean
1247088|NCT00530790|Primary|12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline|Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.|Baseline, Week 4, 8, 12, 13 (Follow-up)|Safety Population - (Baseline = 35 subjects, Week 4 = 33 subjects, Week 8 = 31 subjects, Week 12/EW = 33 subjects and Week 13 [Follow-up] = 35 subjects evaluated).|||Participants|||Number
1247089|NCT00530790|Primary|Urinalysis Clinical Lab Values|Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.|Baseline - Week 13 (Follow-up)|Safety Population (Baseline, Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 [Follow-up] = 35 subjects evaluated).|||Participants|||Number
1247090|NCT00530790|Primary|Blood Chemistry Clinical Lab Values Change From Baseline|Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L|Baseline - Week 13 (Follow-up)|Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).|||Varied Standard Units of Measure||Standard Deviation|Mean
1247091|NCT00530790|Primary|Haematology Clinical Lab Values Change From Baseline|Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.|Baseline - Week 13 (Follow-up)|Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).|||Varied Standard Units of Measure||Standard Deviation|Mean
1247092|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score|The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47|Baseline and Week 12/EW|Full Analysis Set(FAS)|||Points on a scale||Standard Deviation|Mean
1247093|NCT00530790|Secondary|Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains|The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0–21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.|Baseline - Week 12/EW|Full Analysis Set(FAS)|||Points on a scale||Standard Deviation|Mean
1247094|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0–21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.|Baseline - Week 12/EW|Full Analysis Set(FAS)|||Points on a scale||Standard Deviation|Mean
1247095|NCT00530790|Secondary|Clinical Global Impression Global Improvement (CGI-GI)|CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).|Baseline - Final assessment point|Full Analysis Set Population (Weeks 1, 2, 3, and 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Week 10, 12 = 30 subjects; Final assessment point = 35 subjects). Method for missing date is LOCF.|||Participants|||Number
1247096|NCT00530790|Secondary|Clinical Global Impression Scale - Severity of Illness (CGI-S)|The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).|Baseline - Final assessment point|Full Analysis Set Population (Baseline, Weeks 1, 2, 3, 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Weeks 10 and 12 = 30 subjects; Final assessment point = 35 subjects). Method of Missing Data = LOCF.|||Participants|||Number
1247097|NCT00530790|Secondary|Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score|The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.|Baseline and after Week 12|Full Analysis Set: Subjects entered to the treatment period, except for those not fulfilling the major registration criteria, those who did not take even one dose of the study medication, and those for whom no observation data were available after starting the study treatment. Method for missing data is Last Observation Carried Forward (LOCF).|||Points on a scale||Standard Deviation|Mean
1247098|NCT00530790|Primary|Drug Related Adverse Events-On-Therapy||Weeks 1 - 12 Treatment Period|Safety Population consisting of the subjects who took at least one dose of the study medication.|||Number of Events|||Number
1247099|NCT00530777|Secondary|Vertical HIV-1 Transmission|Mother-to-child HIV transmission|1 year postpartum|Note the sample size is 73 for each group rather than 74 due to loss to follow-up.|||Participants|||Number
1247164|NCT00530257|Secondary|Behavior Rating Inventory of Executive Function||2 Weeks|Although this was included in the protocol we have not analyzed the results of this rating scale|||units on a scale||Standard Deviation|Mean
1247101|NCT00530764|Secondary|Change in Montgomery Asberg Depression Rating Scale (MADRS)|The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression.|Baseline and End of Treatment (Week 5 or premature termination)||||Score on scale||Standard Deviation|Mean
1247102|NCT00530764|Secondary|Change in Patient Global Impression of Change - PGIC|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to cancer since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|End of Week 5||||Participants|||Number
1247103|NCT00530764|Secondary|Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)|The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement.|Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)||||Score on scale||Standard Deviation|Mean
1247104|NCT00530764|Secondary|Change in Brief Pain Inventory – Short Form (BPI-SF)|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). the minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)||||Score on scale||Standard Deviation|Mean
1247105|NCT00530764|Secondary|Change in Sleep Disruption NRS|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)||||Points on scale||Standard Deviation|Mean
1247106|NCT00530764|Secondary|Change in Mean Daily NRS Pain Score (Worst Pain).|"The worst pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your worst pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in worst pain score from baseline."|5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)||||Points on scale||Standard Deviation|Mean
1247107|NCT00530764|Secondary|Change in Mean Daily NRS Pain Score (Average Pain).|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline."|5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)||||Points on scale||Standard Deviation|Mean
1247108|NCT00530764|Secondary|Change in Cumulative Average Pain Response Curves|"The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response.~The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer."|Baseline to end of treatment (Week 5)||||Percent Change||Inter-Quartile Range|Median
1247109|NCT00530764|Primary|Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening."|5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)||||Participants|||Number
1247110|NCT00530712|Secondary|Duplex Ultrasound ≤ 2.4 Primary Patency|Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.|1 Year||||Event free percentage||95% Confidence Interval|Number
1247111|NCT00530712|Secondary|Walking Improvement||1 Year|||||||
1247112|NCT00530712|Secondary|Absolute Claudication Distance Improvement|Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.|1 Year||||Miles||Standard Deviation|Mean
1247113|NCT00530712|Secondary|Secondary Patency|Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.|1 Year||||Event free percentage||95% Confidence Interval|Number
1247114|NCT00530712|Secondary|Assisted Primary Patency|Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.|1 Year||||Event free percentage||95% Confidence Interval|Number
1247116|NCT00530712|Secondary|Improvement in Rutherford Clinical Category|Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.|1 Year||||Percentage of participants with data|||Number
1247117|NCT00530712|Secondary|Decline in Rutherford Clinical Category|Defined as an increase of one or more categories in RCC compared to baseline.|30 Days|||||||
1247118|NCT00530712|Secondary|Stent Fracture Rate|Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. only 1 year data presented here.|1, 2 and 3 Years||||percentage of stents implanted|Participants||Number
1247119|NCT00530712|Secondary|Major Adverse Events|MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.|1 Year||||Percentage of particants with data|||Number
1247120|NCT00530712|Secondary|Single-Stent Major Adverse Events|MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.|30 Days||||Percentage of participants with data|||Number
1247121|NCT00530712|Secondary|Single-Stent Primary Patency|Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.|1 Year||||Percentage of participants with data|||Number
1247122|NCT00530712|Primary|Major Adverse Events|Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)|30 Days||||Percentage of participants with data|||Number
1247123|NCT00530712|Primary|Primary Patency|Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.|1 Year||||Percentage of participants with data|||Number
1247124|NCT00530634|Primary|Two-year Progression-free Survival From the Date of Surgery|Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).|2 years post-surgery|Study was terminated after accruing only three patients.|||percentage of participants||95% Confidence Interval|Number
1247125|NCT00530504|Primary|Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.|Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.|30 Days||||participants|||Number
1247126|NCT00530439|Primary|Gestational Weight Gain|Weight at gestational week 35 - weight by inclusion|Gestational week 35||||kg||Inter-Quartile Range|Median
1247127|NCT00530439|Secondary|Metabolic Markers||Until 6 months post partum|||||||
1247128|NCT00530439|Primary|Neonatal Intensive Care Unit||Within 1 month postpartum|||||||
1247129|NCT00530439|Primary|Large for Gestational Age||Delivery|||||||
1247130|NCT00530439|Primary|Gestational Diabetes Mellitus||Delivery|||||||
1247131|NCT00530439|Primary|Preeclampsia/Pregnancy Induced Hypertension||Delivery|||||||
1247132|NCT00530439|Primary|Cesarean Section||At delivery|||||||
1247133|NCT00530348|Secondary|Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2|Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years – lesion volume at Baseline)*100/ (lesion volume at Baseline).|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2).|||percent change||Standard Deviation|Mean
1247134|NCT00530348|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2|MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2).|||Z-score||Standard Deviation|Mean
1247135|NCT00530348|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2).|||units on a scale||Standard Deviation|Mean
1248050|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 48 weeks||||liters||Standard Error|Least Squares Mean
1247136|NCT00530348|Secondary|Percentage of Participants Who Were Relapse Free at Year 2|Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.|Year 2|FAS population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1247137|NCT00530348|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug.|||relapses per participant per year||95% Confidence Interval|Number
1247138|NCT00530348|Primary|Percentage of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least next 2 scheduled assessments, that is, 6 consecutive months. Onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants with SAD||95% Confidence Interval|Number
1247139|NCT00530335|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.|8 weeks||||participants|||Number
1247140|NCT00530335|Secondary|Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion|The Fridericia correction of the QT interval(QTcF) was used.|over 8 weeks|All enrolled participants.|||participants|||Number
1247141|NCT00530335|Secondary|Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study|Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%.|over 8 weeks|All enrolled participants.|||participants|||Number
1247142|NCT00530335|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study|Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).|over 8 weeks|All enrolled participants.|||participants|||Number
1247143|NCT00530335|Secondary|Change From Endpoint to Baseline in Stroop Color Word Test|An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||number of correct answers||Standard Deviation|Mean
1247144|NCT00530335|Secondary|Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores|"Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales.~Calculate: norm-based score=Z-score*10+50 in each subscale."|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1247145|NCT00530335|Secondary|Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe).|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1247146|NCT00530335|Secondary|Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1247147|NCT00530335|Secondary|Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1247148|NCT00530335|Secondary|Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)|Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1247227|NCT00529633|Primary|Difference in Serum Albumin|"Serum albumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total||||g/dL of Albumin|||Number
1247149|NCT00530335|Secondary|Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)|Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1247150|NCT00530335|Primary|Number of Participants With Adverse Events Leading to Discontinuation||over 8 weeks|All three participants who discontinued due to an adverse event were on atomoxetine doses of between 80 mg/day and 105 mg/day.|||participants|||Number
1247151|NCT00530270|Secondary|Duration of Hypoxemia (Low Blood Oxygen)|Sum of time periods when subject was hypoxemic (Sp02 value less than 92%) since the first dose date/time|Measured at the end of hospital stay|Subject without major protocol violation and received treatment.|||Hours||Standard Deviation|Mean
1247152|NCT00530270|Secondary|Duration of Supplemental Oxygen|Time period between the supplemental oxygen start date/time and first dose date/time, whichever is later, and the supplemental oxygen stop date/time|Measured at the end of hospital stay|Subject without major protocol violation and received treatment.|||Hours||Standard Deviation|Mean
1247153|NCT00530270|Secondary|Duration of Hospitalization|Duration in hours from treatment start time to hospital discharge.|Measured at the end of hospital stay, no maximum number of days|Subject without major protocol violation and received treatment.|||Hours||Standard Deviation|Mean
1247154|NCT00530270|Secondary|Rating of Pain|Change from baseline rating of pain from randomization (baseline) to discharge from the hospital, evaluated every 4 hours. Pain was rated on the Oucher Scale for the pediatric population or numeric rating scale for the adult population, both 0 to 10 with 0 indicating no pain and 10 indicating severe pain.|Measured at the end of the hospital stay|Subject without major protocol violation and received treatment.|||Units on a scale||Standard Error|Mean
1247155|NCT00530270|Primary|Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less|Resolution of symptoms of ACS includes respiratory rate <= upper limit of normal +2, no work of breathing (retractions, nasal flaring, and use of accessory muscles), thoracic pain <= 4, no use of supplemental oxygen, no use of ventilary support, and saturation of peripheral oxygen (Sp02) >= steady state value -2. Symptoms were measured every 4 hours from the first dose of study drug to resolution of symptoms or hospital discharge.|Measured from first dose to end of the hospital stay, no maximum number of days|Subject without major protocol violation and received treatment.|||hours (log transformed)||Standard Deviation|Log Mean
1247156|NCT00530257|Primary|Test of Everyday Attention for Children: Opposite Worlds|The TEA-Ch is a battery of subtests designed to assess multiple attentional capacities in children 6-16y.o. The Opposite Worlds subtest is a measure of attentional control and response inhibition. There is not a finite range of scores on this test. Lower scores indicate better performance..|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
1247157|NCT00530257|Primary|Test of Everyday Attention for Children: Sky Search|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search subtest is a measure of selective attention. There is not a finite range of scores on this subtest, but lower scores indicate better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
1247158|NCT00530257|Primary|Test of Everyday Attention for Children: Map Mission|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
1247159|NCT00530257|Primary|Test of Everyday Attention for Children: Creature Counting|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Creature Counting subtest is a measure of attentional control. There is not a finite range for this test, but lower scores indicate better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
1247160|NCT00530257|Primary|Test of Everyday Attention for Children: Score Dual Task (DT)|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Score DT subtest is a measure of sustained attention. and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
1247161|NCT00530257|Primary|Test of Everyday Attention for Children-Sky Search Dual Task|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search Dual Task is a measure of sustained attention. Lower scores indicate better performance. There is not a finite range for this test and very high scores can be negative numbers.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
1247162|NCT00530257|Other Pre-specified|Stimulant Side Effect Rating Scale|Parents rate 16 possible stimulant side effects on a 10 point likert scale from 0-9 with 0 indicating no side effects and 9 indicating more severe symptoms.|2 weeks||||Units on a scale||Standard Deviation|Mean
1247163|NCT00530257|Secondary|ADHD Rating Scale-IV, Parent and Teacher Version|This is the parent and teacher version of the ADHD Rating Scale-IV. The scale has 2 subscales, one for inattention and one for hyperactivity-impulsivity. The scores provided are percentile scores and can range from 1 to 99 percent. Higher scores indicate more problems in inattention or with hyperactivity-impulsivity|2 Weeks|We had complete data for all 30 subjects for the parent rating scale. We only had 24 sets of complete data for the teacher rating scale as some teachers did not return a rating scale when the subject was on both medication and placebo|||Percentile||Standard Deviation|Mean
1247165|NCT00530257|Primary|Wechsler Intelligence Scale for Children-IV, Digit Span Subtest|The verbal assessment of working memory uses the digit span reversed component of the Digit Span subtest of the Wechsler Intelligence Scale for Children-IV edition (WISC-IV).Scores could range from 0 to 16 with higher scores indicating better performance.|2 weeks|The 30 subjects who completed both arms of the crossover analysis|||units on a scale||Full Range|Median
1247166|NCT00530257|Primary|Gordon Diagnostic System Continuous Performance Test|This is a measure of sustained attention & response inhibition for children 6 yrs and older. During this task a series of numbers flash, one at a time, on a screen. The subject is told to press a button every time a “1” is followed by a “9”. There are 45 possible correct responses over the 9-minute task. Omission errors are a measure of sustained attention and can range from 0 to 45. Commission errors are a measure of sustained attention and response inhibition can range from zero to hundreds (each time the button is pushed at the incorrect time). Lower scores indicate better performance.|2 weeks|31 participants began the crossover phase of the trial and 30 completed both the medication and placebo arms. For one patient there was an equipment problem so that subject did not have data available|||errors||Full Range|Median
1247167|NCT00530257|Primary|Test of Everyday Attention for Children: Walk, Don't Walk|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Walk-Don’t Walk subtest is a measure of sustained attention and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
1247168|NCT00530218|Primary|Compliance Rate Among Patients With CMV Reactivation|CMV reactivation patients completed 6-week GCV therapy.|From first ganciclovir positive test to the end of the 6th week GCV therapy|Among the 36 patients with CMV reactivation, two patients are in-evaluable for compliance.|||participants|||Number
1247169|NCT00530218|Primary|Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment||Twice Weekly after day 21 post-transplant||||Participants|||Count of Participants
1247170|NCT00530218|Primary|Number of Participants With Adverse Events|This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.|From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant|Patients are treated with Intravenous Ganciclovir followed by Oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.|||Participants|||Count of Participants
1247171|NCT00530088|Primary|Local Toxicity|Number of patients with an adverse event|30 days|All treated and eligible patients|||participants|||Number
1247172|NCT00530088|Primary|Response|"Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy.~9.23 No Response. All responses less than a Partial Response are considered as No Response.~9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia."|2 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1247173|NCT00530075|Secondary|SF-36|Assessment of the impact of gusperimus on general health using the Short form-36 (SF-36) questionaire. The SF-36 is a self-report, 36 item survey measuring health-related quality-of-life. Thirty-five items are used to construct 8 scales: (1) physical functioning, (2) role physical, (3) bodily pain, (4) general health, (5) vitality, (6) social function, (7) role emotional, and (8) mental health. Raw scores are calculated as the sum of re-coded scale items and transformed to a 0 to 100 scale. If scores for all 8 scales are available, two summary measures known as component scores are derived: the Physical Health Component Score (PCS) and the Mental Health Component Score (MCS). First each scale standardized to the relevant population. Then PCS and MCS are calculated as the weighted sum of standardized scores. All scales and the component scores are positively scored so that higher scores represent better health-related quality-of-life.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy Population|||Score on a scale||Full Range|Median
1247174|NCT00530075|Secondary|Vasculitis Damage Index (VDI)|Assessment of the degree of irreversible damage due to the vasculitis using VDI scoring system. The VDI comprises 64 items of damage (grouped into 11 organ-based systems). Total VDI score is 0 - 64. The higher scores represent the more severe damage occurred in patients. The VDI score can either increase or remain the same over time.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks, 6 months of follow-up period|Efficacy Population|||Score on a scale||Full Range|Median
1247175|NCT00530075|Secondary|CRP|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: serum C-reactive protein level.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Patients who had elevated CRP level (> 6 mg/dL) at entry|||mg/dL||Full Range|Median
1247176|NCT00530075|Secondary|ANCA|"Assessment of anti-neutrophil cytoplasmic antibody (ANCA): Number of ANCA-positive patients was counted.~ANCA are highly associatred with active WG, with c-ANCA titres observed in 90% of WG. In addition to their diagnostic value, it has been suggested that ANCA may have a predictive value for relapse in patients with systemic vasculitis."|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy Population|||Number of participants|||Number
1247177|NCT00530075|Secondary|Creatinine|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: serum creatinine level|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy population|||micromol/L||Full Range|Median
1247178|NCT00530075|Secondary|Haematuria|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: number of hematuria-positive patients.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy population|||Number of participants|||Number
1247179|NCT00530075|Secondary|Duration of Clinical Response|Time from Complete Remission or Partial Remission to Relapse.|At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks, End of treatment period, and 3 and 6 months of follow-up period|Patients who had relapsed after achieved at least partial remission|||Days||Full Range|Median
1247180|NCT00530075|Primary|Remission of Vasculitis|"The primary efficacy outcome measure was remission of vasculitis. Complete remission was defined as a Birmingham vasculitis activity score (BVAS) of 0 sustained for at least 2 months. Partial remission was defined as a reduction in BVAS of 50% or more, sustained for at least 2 months, when compared with the BVAS at entry.~Entry required active Wegener's granulomatosis with a BVAS >= 4. Their disease had to be active, as measured with BVAS in which clinical manifestations caused by active vasculitis are scored on a list of predefined organ-specific items."|At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks|Efficacy Population|||Percentage of participants|||Number
1247181|NCT00530023|Secondary|Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15|Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result.|Baseline and 15 weeks||||Scores on a scale||Standard Deviation|Mean
1247182|NCT00530023|Secondary|Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15|Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.|Baseline and 15 weeks||||Scores on a scale||Standard Deviation|Mean
1247183|NCT00530023|Secondary|Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15|Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.|Baseline and 15 weeks||||Scores on a scale||Standard Deviation|Mean
1247184|NCT00530023|Secondary|Incidence of Severe Hypoglycemia Events Baseline to Week 15|The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15.|Baseline and 15 weeks||||number of events|||Number
1247185|NCT00530023|Primary|Change in A1C From Baseline to Week 15|Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.|Baseline and 15 weeks||||percent glycated hemoglobin||Standard Deviation|Mean
1247186|NCT00529802|Secondary|Percent Change in FDG-PETUptake Following 2 Weeks of Therapy|The secondary objective was to explore whether an early change in FDG-PET uptake is associated with tumor shrinkage. Change in FDG-PET uptake was calculated using the baseline and 2-week FDG-PET scans.|2 weeks|Patients evaluable for tumor response at 8 weeks who also had both the baseline and 2-week FDG-PET scans.|||% change in avgSUVmax at 2 weeks||Full Range|Mean
1247187|NCT00529802|Primary|Relative Tumor Size Change Following 8 Weeks of Therapy.|The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline.|8 weeks|50 patients were evaluable for response and had a baseline FDG-PET scan.|||Percent change from baseline||Full Range|Mean
1247188|NCT00529789|Other Pre-specified|Adverse Events Leading to Discontinuation|A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder.|Week 0 (Baseline) to 30 Weeks|All enrolled patients.|||participants|||Number
1247189|NCT00529789|Primary|Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV|Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.|Between 18 and 30 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
1247190|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III|Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.|Baseline to 18 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
1247191|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV|The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alkaline Phosphatase (>420 Units/Liter [U/L]); Low Hematocrit (females <0.32; males <0.37); High Inorganic Phosphorus (>1.776 millimoles/L).|Between 18 and 30 Weeks|Total number of patients with baseline (and none abnormal) and post-baseline values in Period IV, based on all values at scheduled and unscheduled visits.|||participants|||Number
1247192|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III|The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alanine transaminase (>165 Units/Liter [U/L]); High Creatine Phosphokinase (females: >507 U/L; males:>594 U/L); Low Glucose (<2.498 millimoles/L); Low Hematocrit (females: <0.32; males <0.37); Low Hemoglobin (females <5.896 millimoles/L [mmol/L] iron; males <7.137 mmol/L iron); High Inorganic Phosphorus (>1.776 millimoles/L); Low Leukocyte Count (<2.8 X10^9/L).|Baseline to 18 Weeks|Total number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
1247193|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV|Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.|Between 18 and 30 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
1247194|NCT00529789|Secondary|Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.|Week 0 (Baseline), 18 Weeks, 30 Weeks|18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1247195|NCT00529789|Secondary|Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.|Week 0 (Baseline), 18 Weeks, 30 Weeks|18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1247196|NCT00529789|Secondary|Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose|Plasma samples were obtained at steady state, and approximately 95% of duloxetine concentrations were within the 24 hour dosing interval.|Weeks 2, 4, 6, 8, 10, 14, 18|Number of patients in each duloxetine dose.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1247197|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III|Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.|Baseline to 18 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
1247198|NCT00529789|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Between 18 and 30 Weeks|Number of enrolled patients with baseline and post-baseline values in Period IV.|||participants|||Number
1247199|NCT00529789|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Baseline to 18 Weeks|All enrolled patients.|||participants|||Number
1247200|NCT00529789|Primary|Number of Participants With Emergence of Suicidal Ideation During Period IV|Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).|Week 0 and Between 18 and 30 Weeks|All enrolled patients with data for specified category.|||participants|||Number
1247201|NCT00529789|Primary|Number of Participants With Emergence of Suicidal Ideation During Period II/III|Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).|Baseline to 18 weeks|All enrolled patients with data for specified category.|||participants|||Number
1247202|NCT00529763|Secondary|Mean Apparent Volume of Distribution (Vz/F) of Dasatinib Following 70 mg BID and 100 QD Dose Administration||Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||mL/h||Standard Deviation|Mean
1247203|NCT00529763|Secondary|Mean Oral Clearance (CLo) of Dasatinib Following 70 mg BID and 100 QD Dose Administration||Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||mL/h||Standard Deviation|Mean
1247204|NCT00529763|Secondary|Mean (AUC[0-T]), (AUC[INF]), and (AUC[TAU])of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-T)for dasatinib. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUC(TAU)=area under the plasma concentration-time curve for a dosing interval|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||ng*h/mL||Standard Deviation|Mean
1247205|NCT00529763|Secondary|Mean (Tmax) and (T-Half) of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Tmax=time of maximum observed plasma concentration. T-Half=plasma half-life.|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||hours||Standard Deviation|Mean
1247206|NCT00529763|Secondary|Mean Maximum Concentration (Cmax) of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Cmax=maximum observed plasma concentration of dasatinib|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||ng/mL||Standard Deviation|Mean
1247207|NCT00529763|Secondary|Mean Dasatinib Plasma Concentrations|Mean dasatinib plasma concentrations following 70 mg BID dose in AD CML or Ph+ ALL participants and following 100 mg QD dose in CP CML participants|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Days 6 and 7 (0 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose),|Number of participants analyzed=all treated participants with evaluable PK data; n=number of participants evaluated at time point|||ng/mL||Standard Deviation|Mean
1247208|NCT00529763|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Grade 3/4 Hematologic Abnormalities|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|18 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All CP CML, AD CML, and Ph+ ALL Participants|||Participants|||Number
1247209|NCT00529763|Secondary|Progression-free Survival Among AD CML and Ph+ ALL Participants|The probability to progress after 12 months among AD CML and Ph+ ALL participants. Participants were considered as having Disease Progression (PD) if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All AD CML and Ph+ ALL Participants. Subjects who neither progressed nor died were censored on the date of their last hematologic or cytogenetic assessment.|||percentage (probability)||95% Confidence Interval|Number
1247210|NCT00529763|Secondary|Duration of MaHR Among AD CML and Ph+ ALL Participants|Durability of MaHR, as measured by the probability of duration of MaHR > 12 months. Major HR (MAHR) includes CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils and <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 and <100,000/mm3; ANC >500/mm3 and <1,000/mm3.|Duration of MaHR was measured for AD CML and Ph+ ALL subjects with MaHR from the first day all criteria were met for MaHR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)|Number of responders. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|||percentage (probability)||95% Confidence Interval|Number
1247211|NCT00529763|Secondary|Duration of CHR Among AD CML and Ph+ ALL Participants|Durability of CHR, as measured by the probability of duration of CHR >12 months. CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils and <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly.|Duration of CHR was measured for AD CML and Ph+ ALL subjects with CHR from the first day all criteria were met for CHR until the date of disease progression (PD) or death.(data cut-off date: 18-Jun-2010)|Number of responders. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment|||percentage (probability)||95% Confidence Interval|Number
1247212|NCT00529763|Secondary|Time to Complete and Major Hematologic Response (CHR and MaHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Participants (Ph+ ALL)|Median time to CHR and MaHR, in weeks. Time to CHR is defined for AD CML and Ph+ALL subjects as the time from first dose of Dasatinib until the first day CHR criteria are met (for all confirmed responses). Time to CHR is computed only for subjects whose best response is CHR. Major HR (MaHR) includes CHR or no evidence of leukemia (NEL). See Outcome Measure 1 for definitions of CHR and MaHR.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|Number of Participants Analyzed=All treated participants. n= number of responders.|||weeks||Full Range|Median
1247213|NCT00529763|Secondary|Progression-free Survival Among CP CML Participants|The probability to progress after 12 months among CP CML participants. Participants were considered as having Disease Progression (PD) if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All CP CML Participants.Subjects who did not progress nor died were censored at their last tumor assessments.|||percentage (probability)||95% Confidence Interval|Number
1247214|NCT00529763|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants|The Durability of MCyR as measured by the probability of duration of MCyR >12 months. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM).|Duration of MCyR was measured for CP CML subjects with MCyR from the first day all criteria were met for CCyR or PCyR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)|All treated participants in this cohort who were responders. Subjects who did not progress nor died were censored at their last tumor assessments.|||percentage (probability)||95% Confidence Interval|Number
1247215|NCT00529763|Secondary|Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants|Time to MCyR is defined for CP CML subjects with MCyR as the time from first dose of dasatinib until the first day criteria for CCyR or PCyR, whichever occurs first. Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM).|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort who were responders.|||weeks||Full Range|Median
1247216|NCT00529763|Secondary|Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR)|For CP CML, a Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; < 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort|||percentage of participants||95% Confidence Interval|Number
1247217|NCT00529763|Primary|Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Subjects (Ph+ ALL)|MaHR=CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils & <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 & <100,000/mm3; ANC >500/mm3 & <1,000/mm3. OHR=CHR+NEL+ return to chronic phase (RTC=<15% blasts in BM and PB; <30% blasts+promyelocytes in BM & PB; <20% basophils in PB; no extra-medullar disease other than spleen & liver)|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in these cohorts|||percentage of participants||95% Confidence Interval|Number
1247218|NCT00529763|Primary|Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow [BM]) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in [BM]).|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort|||percentage of participants||95% Confidence Interval|Number
1247219|NCT00529659|Secondary|Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score|The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.|Baseline, Month 6|N = Number of patient with at least one non-missing measurement at the time point.|||Score on a Scale||Standard Deviation|Mean
1247220|NCT00529659|Secondary|Change From Baseline in Stair Climbing Power|"Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says go and ends when both of the patient’s feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time."|Baseline, Month 6|The FAS included all participants that received at least one dose of the study therapy and had a post-randomization stair climbing power measurement.|||watts||Standard Deviation|Mean
1247221|NCT00529659|Secondary|Change From Baseline in Participant Gait Speed||Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.|||cm/sec||Standard Deviation|Mean
1247222|NCT00529659|Primary|Change From Baseline in Bilateral Leg Press (BLP) Measurement|BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.|Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.|||lbs||Standard Deviation|Mean
1247223|NCT00529659|Secondary|Change From Baseline in Participant Short Physical Performance Battery (SPPB)|The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.|Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.|||Score on a Scale||Standard Deviation|Mean
1247224|NCT00529659|Primary|Change From Baseline in Participant Lean Body Mass||Baseline, Month 6|The full analysis set (FAS) included all participants that received at least one dose of the study therapy and had a post-randomization measurement of lean body mass.|||kg||Standard Deviation|Mean
1247225|NCT00529633|Primary|Difference in Serum Prealbumin|"Serum Prealbumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total|Participant data is not available due to no shipping of specimen to analyzing laboratory||||||
1247226|NCT00529633|Primary|Difference in Serum CRP|"Serum CRP in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total||||Mg/L CRP|||Number
1247228|NCT00529568|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
1247229|NCT00529568|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Kilograms (kg)||Standard Deviation|Mean
1247230|NCT00529568|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase|Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||beats per minute||Standard Deviation|Mean
1247231|NCT00529568|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1247232|NCT00529568|Secondary|Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS."|End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1247233|NCT00529568|Secondary|Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase|Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1247234|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication|Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population|||participants|||Number
1247235|NCT00529568|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population|||participants|||Number
1247246|NCT00529568|Secondary|Median Platelet Count at the Indicated Time Points During the DB Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Gi/L||Full Range|Median
1247236|NCT00529568|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)|Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population: all randomized participants who had received study drug in the DB Phase|||participants|||Number
1247237|NCT00529568|Secondary|Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)|There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study. Only those participants who were analyzed for SVR and RVR were considered.|||participants|||Number
1247238|NCT00529568|Secondary|Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase|The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1247239|NCT00529568|Secondary|Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase|The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. One participant could have had more than one dose reduction.|||participants|||Number
1247240|NCT00529568|Secondary|Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase|Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. Only those participants with dose reductions were analyzed.|||weeks||Standard Deviation|Mean
1247241|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase|Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1247242|NCT00529568|Secondary|Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase|ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1247243|NCT00529568|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1247244|NCT00529568|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1247245|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy|The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1247247|NCT00529568|Secondary|Median Platelet Count at the Indicated Time Points During the OL Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Gi/L||Full Range|Median
1247248|NCT00529568|Secondary|Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase|In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <100 Gi/L. Participants who achieved platelet counts >=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.|From Baseline up to Week 9 in the OL Phase|Safety Population. Participants with a platelet count >=100 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.|||participants|||Number
1247249|NCT00529568|Secondary|Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase|Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in the OL Phase|Safety Population: all participants who had received study drug in the OL Phase|||participants|||Number
1247250|NCT00529568|Primary|Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase|Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase|||participants|||Number
1247251|NCT00529555|Primary|Change in Pocket Depth.|Average change of Pocket Depth at 9 months from baseline|baseline & 9 months|Intent to treat|||mm||95% Confidence Interval|Least Squares Mean
1247252|NCT00529542|Post-Hoc|Body Mass Index||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||kg/m2||Standard Deviation|Mean
1247253|NCT00529542|Post-Hoc|Mean Ovarian Volume|Pelvic ultrasound was performed using the 6.5 megahertz (MHz) probe of an ATL 400 machine to characterize ovarian size and morphology. Since in vitro studies demonstrate that statins inhibit ovarian theca-interstitial cell proliferation, we hypothesized that statins might reduce ovarian volume in PCOS.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mm3||Standard Deviation|Mean
1247254|NCT00529542|Post-Hoc|Diastolic Blood Pressure||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mm Hg||Standard Deviation|Mean
1247255|NCT00529542|Post-Hoc|Systolic Blood Pressure||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mm Hg||Standard Deviation|Mean
1247256|NCT00529542|Other Pre-specified|High-sensitivity C-reactive Protein (hsCRP)|high sensitive C-reactive protein as a measure of inflammation|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/L||Standard Deviation|Mean
1247257|NCT00529542|Secondary|DHEAS|Dehydroepiandrosterone sulfate|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||ng/ml||Standard Deviation|Mean
1247258|NCT00529542|Secondary|Androstenedione||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||ng/ml||Standard Deviation|Mean
1247259|NCT00529542|Secondary|Total Testosterone||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||ng/dl||Standard Deviation|Mean
1247260|NCT00529542|Secondary|AUC for Insulin|Area under the curve for insulin during OGTT: A 75 gram oral glucose tolerance test was performed with blood draws at 0, 30, 60, 90 and 120 minutes.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||uU*minute/mL||Standard Deviation|Mean
1247261|NCT00529542|Secondary|Area Under the Curve (AUC) for Glucose During OGTT|A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg*minute/dL||Standard Deviation|Mean
1247262|NCT00529542|Secondary|Fasting Insulin||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||uU/ml||Standard Deviation|Mean
1247263|NCT00529542|Secondary|Fasting Glucose||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
1247264|NCT00529542|Secondary|Triglycerides||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
1247265|NCT00529542|Secondary|HDL Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
1247266|NCT00529542|Secondary|LDL Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
1247267|NCT00529542|Secondary|Total Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
1247278|NCT00529529|Primary|24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 12|Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||bpm||Standard Error|Least Squares Mean
1247268|NCT00529542|Secondary|Peak Brachial Artery Conductance (BAC)|Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5–12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200–250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200–250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||ml/sec/mm Hg||Standard Deviation|Mean
1247269|NCT00529542|Primary|Brachial Artery Flow-mediated Dilation (FMD)|Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||% change in brachial artery diameter||Standard Deviation|Mean
1247270|NCT00529529|Secondary|Number of Asthma Exacerbations Per Patient (Without Imputation) During the 26 Weeks of the Study|An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. The number of asthma exacerbations includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with “asthma” as a key word in the preferred term.|Baseline (Day 1) to end of study (Week 26)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Asthma exacerbations||Standard Deviation|Mean
1247271|NCT00529529|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at Week 12 + 1 Day, Day 85|FEV1 (in liters, L) was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 12, Day 85. The analysis included baseline FEV1 and FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening as covariates.|24 hours post-dose at Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Participants with observations at Day 85 were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1247272|NCT00529529|Primary|Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study|A clinically significant asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with systemic corticosteroids. This includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with “asthma” as a key word in the preferred term.|Baseline (Day 1) to end of study (Week 26)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Percentage of patients|||Number
1247273|NCT00529529|Primary|Blood Glucose 1 Hour Post-dose at Week 12|Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
1247274|NCT00529529|Primary|Blood Glucose 1 Hour Post-dose at Day 1|Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
1247275|NCT00529529|Primary|Serum Potassium 1 Hour Post-dose at Week 12|Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
1247276|NCT00529529|Primary|Serum Potassium 1 Hour Post-dose at Day 1|Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
1247277|NCT00529529|Primary|24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 26|Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 26|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 26 were included in the analysis.|||bpm||Standard Error|Least Squares Mean
1247288|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247279|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 21|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 21|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 21 were included in the analysis.|||ms||Standard Error|Least Squares Mean
1247280|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 12|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||ms||Standard Error|Least Squares Mean
1247281|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia’s Formula Measured 1 Hour Post-dose at Day 1|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.|||ms||Standard Error|Least Squares Mean
1247282|NCT00529529|Primary|Diastolic Blood Pressure 1 Hour Post-dose at Week 12|Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1247283|NCT00529529|Primary|Diastolic Blood Pressure 1 Hour Post-dose at Day 1|Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
1247284|NCT00529529|Primary|Systolic Blood Pressure 1 Hour Post-dose at Week 12|Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1247285|NCT00529529|Primary|Systolic Blood Pressure 1 Hour Post-dose at Day 1|Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and forced expiratory volume in 1 second (FEV1) pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1247286|NCT00529529|Primary|Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study|Adverse events include asthma exacerbations. An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. Asthma worsening that required treatment with inhaled or nebulized short-acting β2-agonists or an increase in inhaled corticosteroids only was not considered an asthma exacerbation.|Baseline (Day 1) to end of study (Week 26)|Safety population: All patients who received at least one dose of study drug.|||Percentage of patients|||Number
1247287|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247312|NCT00529451|Secondary|Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP|To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.|Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||Percentage of participants|||Number
1247289|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247290|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker|Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247291|NCT00529516|Secondary|Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers|Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247292|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247293|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247294|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247295|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker|Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247296|NCT00529516|Secondary|Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers|Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
1247297|NCT00529516|Secondary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1247298|NCT00529516|Secondary|Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1247299|NCT00529516|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1247300|NCT00529516|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1247301|NCT00529516|Secondary|Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)|Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.|During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Subjects|||Number
1247302|NCT00529516|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Subjects|||Number
1247303|NCT00529516|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Subjects|||Number
1247304|NCT00529516|Primary|Duration of Solicited General Adverse Events|Duration was expressed as the median number of days the symptom was experienced.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that experienced the specific symptom.|||Days||Full Range|Median
1247305|NCT00529516|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)|Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.|||Subjects|||Number
1247306|NCT00529516|Primary|Duration of Solicited Local Adverse Events|Duration was expressed as the median number of days the symptom was experienced.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that reported the specific symptom.|||Days||Full Range|Median
1247307|NCT00529516|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.|||Subjects|||Number
1247308|NCT00529464|Primary|Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP)|A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed.|Up to 2 years|The primary outcome measure could not be assessed because no subject received randomized treatment assignment. The study was terminated.||||||
1247309|NCT00529451|Primary|Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||mm Hg||Standard Error|Least Squares Mean
1247310|NCT00529451|Primary|Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||mm Hg||Standard Error|Least Squares Mean
1247311|NCT00529451|Primary|Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||mm Hg||Standard Error|Least Squares Mean
1247313|NCT00529451|Secondary|Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg|To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.|Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||Percentage of participants|||Number
1247314|NCT00529451|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint|To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||mm Hg||Standard Error|Least Squares Mean
1247315|NCT00529399|Primary|The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|Based on mixed meal tolerance test (MMTT) conducted at the one year visit||||nmol/L||95% Confidence Interval|Geometric Mean
1247316|NCT00529308|Primary|"Number of Patients With Improved or Minimally Improved in Clinical Global Impression-Improvement (CGI) Scale"|The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to “Minimal Improvement,” “Much Improved” or “Very Much Improved,” respectively. CGI-I ratings of “Much” or “Very Much Improved” at post-treatment are used to identify treatment responders.|3 weeks||||participants|||Number
1247317|NCT00529308|Primary|Motor Cortex Excitability Normalization-Left Motor Threshold|Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.|3 weeks|This data was only available for the subjects at the Yale site only.|||µV||Standard Deviation|Mean
1247318|NCT00529308|Primary|"Number of Patients With Much Improved or Very Much Improved on Clinical Global Impression-Improvement (CGI) Scale"|The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to “Minimal Improvement,” “Much Improved” or “Very Much Improved,” respectively. CGI-I ratings of “Much” or “Very Much Improved” at post-treatment are used to identify treatment responders.|3 weeks||||participants|||Number
1247319|NCT00529308|Primary|Motor Cortex Excitability Normalization-Right Motor Threshold|Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.|3 weeks|This data was only available for the subjects at the Yale site only.|||µV||Standard Deviation|Mean
1247320|NCT00529308|Primary|Yale Global Tic Severity Scale (Y-GTSS)|Y-GTSS is a clinician-rated scale used to assess tic severity. Motor and phonic tics are rated separately from 0 to 5 on several scales including number, frequency, intensity, complexity, and interference. Thus Motor and Phonic Tic scores can range from 0 to 25; the combined Total Tic Score ranges from 0 to 50. There is also an Impairment score that rates the overall burden due to tics. The Impairment scale yields a single score from 0 to 50 with higher scores indicating higher levels of overall impairment associated with tics.|3 weeks||||units on a scale||Standard Deviation|Mean
1247321|NCT00529282|Secondary|Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug|To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the unmodified initial course of therapy, and receiving no prophylactic antibiotics after the EOT visit.|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.||||||
1247322|NCT00529282|Secondary|Clinical Success at 72 Hours|To compare the clinical success rate (absence or improvement of signs and symptoms of infection) at 72 hours after starting ceftobiprole with that of cefepime with or without vancomycin|72 hours after starting study drug|No outcome measures were analyzed due to early termination of the study.||||||
1247323|NCT00529282|Secondary|Clinical Cure Regardless of Modification of Therapy|To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the initial course of therapy, regardless of modification of therapy defined as addition of an anti-fungal agent and/or an aminoglycoside. Cure with modification: The subject requires antifungals, which will be considered a failure for the primary endpoint. The subject needs modification of study therapy by adding one or more agents (other than protocol-defined chemoprophylaxis antibiotics).|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.||||||
1247324|NCT00529282|Primary|Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.|Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. Cure without modification: A subject will be considered to be cured at the primary efficacy visit if: The subject’s fever and clinical signs and symptoms are resolved to the extent that no further anti-infective therapy is necessary as determined by the investigator Any infecting organisms that were identified at baseline were eradicated|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.||||||
1247325|NCT00529243|Secondary|Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24|To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen.|24 Weeks|Analysis was per intention to treat (ITT) population defined as all patients who received at least one dose of raltegravir.|||cells/mm^3||Full Range|Mean
1247326|NCT00529243|Primary|Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.|To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.|24 Weeks|Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir.|||participants|||Number
1247327|NCT00529217|Secondary|Clinical Improvement (CGI-S)|"Minimum CGI-S score: 1 Maximum CGI-S score: 7~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.~Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.~= Normal, not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients"|6, 9, or 12 weeks||||responders (CGI-S = 1 or 2)|||Number
1247328|NCT00529217|Primary|Cambridge Depersonalization Scale (CDS)|"Change on CDS from baseline. Scale item number: 29 Item score range: Frequency: 0 - 4, Duration: 0-5 Minimum CDS score: 0 Maximum CDS score: 261~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement."|6, 9, or 12 weeks||||responders (>50% reduction in CDS score)|||Number
1247329|NCT00529204|Secondary|Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes||24 weeks||||adverse events|||Number
1247330|NCT00529204|Secondary|Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis|"Steatosis was grades on a scale of 0 (< 5%); 1 (5%- 33%); 2 (> 33% - 66%); and 3 (> 66%).~Inflammation was graded on a scale of 0 (No foci); 1 (< 2 foci per 200 X field); 2 (2-4 foci per 200 X field); and 3 (>4 foci per 200 X field) Fibrosis was graded on a scale of 0 (None); 1 (Mild periportal or perisinusoidal); 2 (Moderate periportal or perisinusoidal); 3 (Bridging fibrosis); and 4 (cirrhosis)"|24 weeks||||units on a scale|||Number
1247331|NCT00529204|Primary|Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy||24 weeks||||IU|||Number
1247332|NCT00529191|Secondary|HDL and LDL Cholesterol Levels in Participants Stratified by the Preservation of Islet Cell Function|"Relationship between atorvastatin's effect on HDL and LDL cholesterol and the preservation of islet cell function.~Islet cell preservation defined as: <7.5% Reduction in C-Pep"|Baseline, Week 1, Month 3, Month 6, Month 9, Month 12,||||mg/dl||Standard Deviation|Mean
1247333|NCT00529191|Secondary|Study Drug Compliance Rate Overall|Compliance is defined as >=80% expected dosage consumed during the visit period.|12 months treatment||||% of compliant participants|||Number
1247334|NCT00529191|Secondary|Number of Episodes of Hypoglycemia Requiring Any Treatment|number of episodes of hypoglycemia requiring any treatment, defined by the need for treatment with glucagon or third party intervention.|Baseline, Month 12, Month 18|All subjects contributing data|||episodes||Standard Deviation|Mean
1247335|NCT00529191|Secondary|Blood Glucose Control (Number of Participants With Hypoglycemia)|Blood glucose control as determined from home glucose meter downloads for the 1 week preceding the visit. The number of subjects with hypoglycemic episodes requiring treatment (BG < 70 mg/dl)|Baseline, Month 12, Month 18|All participants contributing data|||Participants|||Count of Participants
1247336|NCT00529191|Secondary|Levels of HbA1c at Months 3, 6, 9, 12 and 18||3, 6, 9, 12, and 18 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
1247337|NCT00529191|Secondary|Mean Daily Insulin Dose Per kg Body Weight for 7 Days|Mean daily insulin dose per kg body weight for the 1 week preceding each scheduled study visit.|Visit 1, 2, 3, 4, 5, 6, 7||||units/kg||Standard Deviation|Mean
1247338|NCT00529191|Secondary|% Subjects Without Change in 2-hour C-peptide AUC in Response to the MMTT at Baseline vs. 12 Months|The C-peptide AUC measurements are collected over a 2 hour period (with 30 minute intervals) after a Mixed Meal Tolerance Test. The area under the curve from these combined measurements (from 0 to 120 or 0 to 240 minutes) is calculated and the unit of measure is nanogram*minutes/ml. The change in C-peptide AUC in response to a 2 hour MMTT at baseline vs 12 months were calculated, and efficacy (success) is defined as < 7.5% reduction.|Baseline vs 12 months||||% of participants with efficacy|||Number
1247339|NCT00529191|Primary|Efficacy of a Daily Dose of Atorvastatin to Maintain Islet Cell Function as Measured by a 4-hour C-peptide Area Under Curve (AUC) in Patients With Newly Diagnosed Type 1 Diabetes Mellitus|The change in C-peptide measurements collected over a 4 hour period (0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes) after a Mixed Meal Tolerance Test at baseline vs 12 months post-treatment were calculated. The area under the curve for these combined measurements is calculated and the unit of measure is nanogram x minutes / mL. Efficacy (success) is defined by < 7.5% reduction in AUC for 4-hr MMTT.|Baseline vs 12-month|Participants who completed their 12-month treatment were included in the analysis, in which the change in C-peptide AUC at baseline and 12-months were calculated. Efficacy (success) is defined by < 7.5% reduction in AUC for 4-hr MMTT.|||nanogram*minutes/ml||Standard Deviation|Mean
1247340|NCT00529152|Secondary|Change in Serum Ferritin Concentration From Baseline.|The change in serum ferritin concentration from baseline to week 24 was measured and analyzed for all participants in the study|Baseline and 24 weeks|99 subjects had at least one post baseline measurement of serum ferritin concentration and were eligible for the efficacy analyses in the Intent to Treat population (all subjects). The Last Measurement Carried Forward methodology was used to populate any missing serum ferritin value.|||ug/L||Standard Deviation|Mean
1247341|NCT00529152|Primary|Occurrence of Adverse Events|Number of Adverse Events over 24 weeks|24 Weeks|All subjects enrolled (100), had at least one dose of Ferriprox oral solution, all were included in safety analysis|||Adverse Events|||Number
1247342|NCT00529126|Secondary|Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days||Up to 30 days|||||||
1247343|NCT00529126|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question: “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?”|0 to 72 hours||||units on a scale*hrs||Standard Deviation|Mean
1247344|NCT00529100|Secondary|Phase 2: Site of Progressive Disease (PD)|Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and who had PD.|||participants|||Number
1247345|NCT00529100|Secondary|Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease * 100, where objective responders are those participants who have met criteria either for CR or PR.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and with measurable disease.|||percentage of participants||95% Confidence Interval|Number
1247346|NCT00529100|Secondary|Progression Free Survival (PFS)|PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).|Baseline to measured PD (up to 36 months)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eight participants were censored.|||months||95% Confidence Interval|Median
1247347|NCT00529100|Secondary|Phase 2: Percentage of Participants With Progression Free Survival (PFS)|The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD.|Baseline and 1 year and 2 years and 3 years|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).|||percentage of participants||95% Confidence Interval|Number
1247348|NCT00529100|Secondary|Phase 2: Time to Progressive Disease (PD)|Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eleven participants were censored.|||months||95% Confidence Interval|Median
1247349|NCT00529100|Secondary|Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years|OS was defined as the time from date of enrollment to death due to any cause.|Baseline and 2 years and 3 years|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).|||percentage of participants||95% Confidence Interval|Number
1247350|NCT00529100|Secondary|Phase 1: Number of Participants With Adverse Events (AE; Toxicity)|A listing of AEs is located in the Reported Adverse Event module.|Baseline to measured PD (up to 1 year)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).|||participants|||Number
1247351|NCT00529100|Primary|Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year|OS was defined as the time from date of enrollment to death due to any cause.|Baseline to date of death from any cause (up to 1 year)|The treated population was considered the primary analysis population for the efficacy endpoints. The efficacy analysis was also completed on the protocol-qualified (PQ)population to assess the sensitivity of the results.|||percentage of participants||95% Confidence Interval|Number
1247352|NCT00529100|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy|Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.|Baseline to measured progressive disease (PD; up to 1 year)|The treated population included all participants who received at least 1 dose of either study therapy (that is, pemetrexed, cisplatin, or radiation).|||milligrams per square meter (mg/m^2)|||Number
1247380|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks|This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.|Baseline and 480 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247353|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). A complete RFBM has a sensation of complete evacuation.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage change||Standard Error|Mean
1247354|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none, 1 = mild and 4=very severe.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage change||Standard Error|Mean
1247355|NCT00529087|Secondary|Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.|weeks 5-12|Patients who continued into the open-label period and received at least 1 dose of test article.|||percentage of participants|||Number
1247356|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage change||Standard Error|Mean
1247357|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1=separate hard lumps like nuts (difficult to pass) and Type 7=watery, no solid pieces (entirely liquid.) Specifically, Type 3=like a sausage but with cracks on the surface, Type 4=Like a sausage or snake, smooth and soft.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage change||Standard Error|Mean
1247358|NCT00529087|Secondary|Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article.|||percentage of participants|||Number
1247359|NCT00529087|Secondary|Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article.|||percentage of participants|||Number
1247360|NCT00529087|Secondary|Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||units on scale||Standard Error|Mean
1247361|NCT00529087|Secondary|Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||units on scale||Standard Error|Mean
1247381|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks|This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.|Baseline and 432 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247362|NCT00529087|Secondary|Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)|A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). Weekly number of complete RFBM was the total number of complete RFBM reported in study period divided by the number of days with information, and multiplied by 7 for a normalized weekly number. A complete RFBM has a sensation of complete evacuation.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||bowel movements||Standard Error|Mean
1247363|NCT00529087|Secondary|Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)|RFBM defined as bowel movement with no laxatives during the prior 24 hours. Information on laxative use, bowel movements and assessments were reported daily by patient. Weekly number of quality RFBM was the total number of quality RFBM reported in study period divided by number of days with information and multiplied by 7 for a normalized weekly number. Stool quality assessed with the Bristol Stool Form Scale (7-points) (1=difficult to pass, 7=entirely liquid). A quality RFBM defined as one other than diarrhea (Bristol Type 1–5).|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||bowel movements||Standard Error|Mean
1247364|NCT00529087|Secondary|Change in Weekly Number of Bowel Movements During Double-blind Period|Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The weekly number of BM was defined as the total number of BMs reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||bowel movements||Standard Error|Mean
1247365|NCT00529087|Secondary|Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.|Baseline and 4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage of participants|||Number
1247366|NCT00529087|Secondary|Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage of participants|||Number
1247367|NCT00529087|Secondary|Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).|Within 1-6 hours during 4-week double-blind period|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).|||percentage of injections||Standard Deviation|Mean
1247368|NCT00529087|Secondary|Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.|Within 1-6 hours during 4 week double-blind period|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).|||percentage of active injections||Standard Deviation|Mean
1247369|NCT00529087|Secondary|Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBM reported during the study week divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article.|||percentage of participants|||Number
1247370|NCT00529087|Secondary|Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBMs reported during study period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number. Weekly number of RFBM determined as missing for <4 days of information.|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article. Observed case analysis.|||bowel movements||Standard Deviation|Mean
1247382|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks|This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.|Baseline and 384 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247371|NCT00529087|Secondary|Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks|A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). The weekly number of RFBM was defined as the total number of RFBM reported during the double-blind period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|Baseline and 4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).|||bowel movements||Standard Error|Mean
1247372|NCT00529087|Secondary|Time to the First Rescue-free Bowel Movement (RFBM) After First Dose|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Responses following first injection were censored at 24 hours or at time of the second injection, which ever occurred first.|up to 24 hours|Patients who were randomized and received at least 1 dose of double-blinded test article.|||% of subjects achieving RFBM in 24 hours|||Number
1247373|NCT00529087|Primary|Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article.|||percentage of active injections||Standard Deviation|Mean
1247374|NCT00529087|Primary|Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).|up to 4 hours|Patients who were randomized and received at least 1 dose of double-blinded test article. For this analysis, the MOA-728 QD and MOA-728 QOD treatment groups were combined as the treatment regimen was the same through the first dose (day 1).|||percentage of participants|||Number
1247375|NCT00529035|Secondary|Treg Cell:Tcon Cell Ratio|"Changes in the ratio of the CD4+ regulatory T cell (Treg) and CD4+ conventional T cell (Tcon) counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.~All study participants (n=28) with a sample available were reported in the data table.~Immune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011)."|Immunological samples taken at study appointments during the 12 week protocol schedule|Participants were evaluated for changes to the ratio of regulatory T cell (Treg) and conventional T cell (Tcon) counts while on IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule to analyze the immunological effects of low-dose IL-2 therapy.|||ratio||Inter-Quartile Range|Median
1247376|NCT00529035|Secondary|CD3+T, CD4+T (Including Regulatory CD4+T Cells (Treg) and Conventional CD4+T Cells (Tcon)), CD8+T, NK, NKT and B Cell Counts.|"Changes in the above immune cell populations (CD3+T, CD4+T (including CD4+Treg and CD4+Tcon), CD8+T, NK, NKT and B cell counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.~All study participants (n=28) with a sample available were reported in the data table.~Immune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011)."|Immunological samples taken at study appointments during the 12 week protocol schedule|Participants were evaluated for regulatory T cell (Treg) expansion and other immune-cell changes while on low-dose IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule. Please note that for NK and NKT cell counts, only 18 participants samples were analyzed.|||cells/cubic millimeter||Inter-Quartile Range|Median
1247377|NCT00529035|Secondary|The Number of Participants Who Tolerated at Least 6 Weeks of Subcutaneous Low Dose IL-2.|"Feasibility: the number of participants who tolerated at least 6 weeks of therapy, and were thus evaluable for response. Efficacy: chronic GVHD response per NIH consensus criteria in evaluable patients.~A complete response was defined as resolution of all reversible chronic GVHD–associated manifestations, a partial response as an improvement of 50% or more on the organ-specific chronic GVHD scale without progression at other organs or sites, progressive disease as an increase of 25% or more on the organ specific chronic GVHD scale, and stable disease as an improvement of less than 50% or increase of less than 25%. Please refer to the Supplementary Appendix in our published report (Koreth et al, NEJM 2011) for further details."|Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy. cGVHD was assessed at Weeks 8 and 12|Participants were evaluable for response and considered meeting the feasibility endpoint if they completed at least 6 weeks of treatment. Participants who had a partial response or complete response in cGVHD to treatment were considered to meet the efficacy endpoint.|||participants|||Number
1247378|NCT00529035|Primary|The Maximum Tolerated Dose and Toxicity Profile of an 8 Week Course of IL-2 in Patients With cGVHD and an Inadequate Response to Steroids.|"Three dose levels were evaluated to determine the maximally tolerated dose (MTD):~Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/m^2/day Once the MTD (dose level B) was established, an additional 10 participants were enrolled at this dose."|Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy|One participant terminated therapy early and was not evaluable for this outcome measure.|||million IU/m2/day|||Number
1247379|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks|This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.|Baseline and 528 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247383|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks|This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.|Baseline and 336 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247384|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks|This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.|Baseline and 288 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247385|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks|This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.|Baseline and 240 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247386|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks|This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.|Baseline and 192 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247387|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks|This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.|Baseline and 144 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247388|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks|This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.|Baseline and 96 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247389|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks|This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.|Baseline and 48 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
1247390|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 528 Weeks|This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.|Baseline and 528 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247391|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 480 Weeks|This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.|Baseline and 480 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247392|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 432 Weeks|This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.|Baseline and 432 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247393|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 384 Weeks|This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.|Baseline and 384 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247394|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 336 Weeks|This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.|Baseline and 336 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247395|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 288 Weeks|This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.|Baseline and 288 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247396|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 240 Weeks|This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.|Baseline and 240 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247397|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 192 Weeks|This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.|Baseline and 192 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247398|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 144 Weeks|This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.|Baseline and 144 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247399|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 96 Weeks|This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.|Baseline and 96 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247400|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 48 Weeks|This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.|Baseline and 48 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
1247401|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF.|528 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247402|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF.|480 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247403|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF.|432 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247404|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF.|384 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247405|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF.|336 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247406|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF.|288 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247407|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF.|240 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247408|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF.|192 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247409|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.|144 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247410|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.|96 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247411|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.|48 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247412|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF.|528 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247413|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF.|480 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247414|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF.|432 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247415|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF.|384 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247416|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF.|336 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
1247417|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF.|288 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247418|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF.|240 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247419|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF.|192 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247420|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.|144 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247421|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.|96 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
1247422|NCT00528957|Secondary|Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)|This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|48 weeks|Intent-to-treat (ITT) Analysis Set; only includes participants < 12 years of age at baseline|||percentage of participants|||Number
1247423|NCT00528957|Secondary|Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)|This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|48 weeks|Intent-to-treat (ITT) Analysis Set; only includes participants < 12 years of age at baseline|||percentage of participants|||Number
1247424|NCT00528957|Primary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.|48 weeks|Intent-to-treat, Missing = Failure|||percentage of participants|||Number
1247425|NCT00528931|Secondary|Change From Baseline Range of Motion|Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees|Baseline, 30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.|||Degrees|Joints|Standard Deviation|Mean
1247426|NCT00528931|Secondary|Percent Change From Baseline Contracture|Change from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture measurement) divided by baseline contracture where a positive change indicates a reduction in the degree of contracture.|Baseline, 30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.|||Percentage of contracture change|Joints|Standard Deviation|Mean
1247427|NCT00528931|Secondary|Clinical Improvement|Clinical improvement defined as ≥50% reduction from baseline in contracture within 30 days of the injection. LOCF after the injection was used if the status at day 30 could not be determined.|30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.|||Percentage of joints|Joints||Number
1247428|NCT00528931|Secondary|Clinical Success|Clinical success defined as a reduction in contracture (ie, flexion deformity) to ≤5° of normal as measured by finger goniometry 30 days after an injection. Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined.|30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection|||Percentage of joints|Joints||Number
1247429|NCT00528931|Primary|Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500|AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).|Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30|Pharmacokinetic population|||participants|||Number
1247430|NCT00528879|Secondary|Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and who had HbA1c values at Baseline and Week 24 (LOCF)|||Percentage of participants|||Number
1247431|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 1|All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 1 (LOCF)|||mg/dL||Standard Error|Mean
1247432|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication, who had a BMI ≥27 kg/m^2 at baseline, and who had nonmissing HbA1c values at Week 24 (LOCF)|||Percent||Standard Error|Mean
1247433|NCT00528879|Other Pre-specified|Number of Participants With Orthostatic Hypotension|Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.|From Baseline to Week 102|All randomized participants who received treatment; n=the number of participants who were not missing blood pressure measurements.|||Participants|||Number
1247434|NCT00528879|Other Pre-specified|Mean Changes From Baseline in Seated Diastolic Blood Pressure|Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 102|All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.|||mm Hg||Standard Error|Mean
1247435|NCT00528879|Other Pre-specified|Mean Changes From Baseline in Seated Systolic Blood Pressure|Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 102|All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.|||mm Hg||Standard Error|Mean
1247436|NCT00528879|Other Pre-specified|Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])|12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.|Baseline to Week 102|All randomized participants who received at least 1 dose of study medication and who had nonmissing baseline and Week 102 (LOCF) values|||Participants|||Number
1247437|NCT00528879|Other Pre-specified|Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality|BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.|Day 1 to Week 102|All randomized participants who received at least 1 dose of study medication and who had nonmissing laboratory values at baseline and Week 102.|||Participants|||Number
1247438|NCT00528879|Other Pre-specified|Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.|From Baseline to end of Long-term Period (Week 102)|All randomized participants who received at least 1 dose of blinded study medication|||Participants|||Number
1247439|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication, who had baseline BMI ≥27 kg/m^2, and who had nonmissing total body weight measurements at Week 24 (LOCF)|||Kilograms||Standard Error|Mean
1247440|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication, who had baseline HbA1c ≥9.0%, and who had nonmissing HbA1c values at Week 24 (LOCF)|||Percent||Standard Error|Mean
1247441|NCT00528879|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values|||Percentage of participants|||Number
1247442|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing total body weights at baseline and Week 24 (LOCF)|||Kilograms||Standard Error|Mean
1247443|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1247455|NCT00528840|Secondary|Change From Baseline Range of Motion After the First Injection|Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion.|Baseline; within 30 days after first injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||degrees|Joints|Standard Deviation|Mean
1248018|NCT00525512|Secondary|Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase|COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.|baseline, 96 weeks||||participants|||Number
1247444|NCT00528879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||Percent||Standard Error|Mean
1247445|NCT00528866|Secondary|Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|Analysis can occur at the same time as the primary endpoint if data is available.|||||||
1247446|NCT00528866|Secondary|Time to “Late” Grade 3+ Adverse Events (Based on CTCAE, v3.0)|Two-year rate shown (cumulative incidence method). Adverse events are graded using CTCAE v3.0. Time of first late adverse event occurrence of the Grade 3+ adverse event between 91 days and 730 days from the completion of treatment (3 weeks after the last planned docetaxel dose) calculated. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From 91 to 730 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1247447|NCT00528866|Secondary|Number of Patients With “Acute” Adverse Events (Based on CTCAE, v3.0)|The number of patients with at least one grade 3 or higher adverse event (AE) from start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed until death or study termination whichever occurs first.|All eligible patients who started study treatment|||participants|||Number
1247448|NCT00528866|Secondary|Time to Biochemical (PSA) Failure (3-year Rate)|Failure is defined as PSA ≥ 0.4 ng/mL confirmed by a second higher PSA or initiation of non-protocol hormones. Death is considered a competing risk. Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1247449|NCT00528866|Secondary|Overall Survival (3-year Rate)|Time from registration to date of death (failure) or last follow-up (censored). Three-year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1247450|NCT00528866|Secondary|Non-prostate Cancer Death (3-year Rate)|Time from registration to date of death due to other causes (failure), death due to prostate cancer (competing risk), or last follow-up (censored).Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1247451|NCT00528866|Secondary|Prostate Cancer Death (3-year Rate)|Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1247452|NCT00528866|Secondary|Distant Metastasis (3-year Rate)|Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1247453|NCT00528866|Secondary|Local-regional Progression (3 Year Rate)|Time from registration to date of local progression (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1247454|NCT00528866|Primary|Number of Participants Free From Progression at 3 Years|Failure was defined as PSA ≥ 0.4 ng/mL after the end of radiation therapy confirmed by a second higher PSA, non-protocol hormones, local-regional progression, distant metastasis, or death, within 3 years after study registration. Freedom from progression (FFP) rate under null hypothesis was 50%; under alternative hypothesis ≥ 70%. Per Fleming's multiple testing procedure with 3 stages, 69 patients (76 allowing for 10% ineligible) were required for 90% power and type I error 0.025. If ≥ 44 of 69 patients had a FFP event, we would reject 50% FFP rate in favor of ≥ 70%. Analysis was out of 74 patients (not 69), so ≥ 44 was revised to ≥ 46.|From registration to 3 years.|All eligible patients who started study treatment|||participants|||Number
1247456|NCT00528840|Secondary|Percent Reduction From Baseline Contracture After the First Injection|Percent change in degree of contracture is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture.|Baseline; within 30 days after first injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of change|joints|Standard Deviation|Mean
1247457|NCT00528840|Secondary|Clinical Improvement After the First Injection|Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection|Baseline; within 30 days after first injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints||Number
1247458|NCT00528840|Secondary|Clinical Success After the First Injection|Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.|Within 30 days after first injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints||Number
1247459|NCT00528840|Secondary|Time to Reach Clinical Success|Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories.|First evaluation visit on which clinical success is achieved through the Day 30 evaluation|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints||Number
1247460|NCT00528840|Secondary|Change From Baseline Range of Motion After the Last Injection|Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.|Baseline, 30 days after last injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||degrees|Number of Joints|Standard Deviation|Mean
1247461|NCT00528840|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture)|Baseline, within 30 days after last injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints|Standard Deviation|Mean
1247462|NCT00528840|Secondary|Clinical Improvement After the Last Injection|Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection.|Baseline; within 30 days after last injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percent of joints|Number of joints||Number
1247463|NCT00528840|Primary|Reduction in Contracture to 5° or Less|"The Primary Outcome Measure is the percentage of joints that were successfully treated where successfully treated was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection"|Within 30 days after the last injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints||Number
1247464|NCT00528801|Secondary|Volume of Total Cortical Gray Matter as Measured by Volumetric MRI.|The cortical gray matter is the gray matter of the cerebral cortex only and does not include subcortical gray matter such as hippocampus or basal ganglia.|Within 2 months of informed consent|Per protocol, no imputations.|||mL||Standard Deviation|Mean
1247465|NCT00528801|Secondary|Participants With Brain Lacunae as Measured by Clinical MRI|Particpants with imaging abnormalities as measured by MRI (Magnetic Resonance Imaging) specifically brain lacunae. Lacunar infarcts are 3-15 mm in diameter located at the basal ganglia, capsular and thalamic regions. Lesions located at the level of the anterior commisure are considered perivascular spaces unless >5 mm in diameter.|Within 2 months of informed consent|Per protocol, no imputation.|||Participants|||Number
1247466|NCT00528801|Primary|Wechsler Adult Intelligence Scale (WAIS)-III Performance IQ|Extent of neurocognitive dysfunction in neurologically asymptomatic adult patients with sickle cell disease as measured by WAIS-III performance IQ. This quotient is based on an average of 100, with a standard deviation of 15. The Wechsler intelligence scales are not considered adequate measures of extremely high and low intelligence (IQ scores above 160 and below 40, respectively). The performance IQ is derived from scores on seven subtests: picture completion, picture arrangement, block design, object assembly, digit symbol, matrix reasoning, and symbol search.|Within 2 months of signing informed consent.|Per protocol, no imputation used.|||Points on a scale||Standard Deviation|Mean
1247467|NCT00528788|Primary|Change in Endothelial Cell Function|Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.|1 month|prospective open-label 30-day observational study testing the effects of doxercalciferol on mediated vasodilation (FMD) among 20 dialysis pts with secondary hyperparathyroidism|||percent change in FMD||Standard Deviation|Mean
1247468|NCT00528775|Secondary|Inflammation and Apoptosis as Assessed by Immunohistochemistry||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1247469|NCT00528775|Secondary|STAT3 Cross-links as Assessed by Western Blotting||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1247470|NCT00528775|Secondary|Photosensitizer (HPPH) Concentration in Tumor||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1247471|NCT00528775|Secondary|Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1247472|NCT00528775|Primary|Tumor Response||6 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1247473|NCT00528645|Secondary|Progression Free Survival|Progression Free Survival (PFS) is defined as the time from registration to documentation of disease progression or death, whichever occurs first. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression or death, assessed up to 2 years||||months||95% Confidence Interval|Median
1247508|NCT00528541|Secondary|Physician Assessment of Cervical Dystonia Severity at Week 4|Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever.'|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Units on a Scale||Full Range|Median
1247474|NCT00528645|Secondary|Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)|Response was assessed using the RECIST v1.1 criteria. Patients were evaluated after every other cycle (after cycle 2, 4, 6, etc...) and when progression is suspected. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart..|After every other 21-day cycle, up to 2 years.||||Participants|||Count of Participants
1247475|NCT00528645|Secondary|Overall Survival|Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
1247476|NCT00528645|Primary|Progression-free Survival Rate at 12 Weeks|"The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients and multiplied by 100. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.~Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as having a new lesion or having at least a 20% increase in the sum of the longest diameter of target lesions from baseline."|12 weeks||||percentage of participants||95% Confidence Interval|Number
1247477|NCT00528606|Secondary|Change From Baseline Range of Motion After the First Injection|Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.|Baseline; within 30 days after the first injection|Modified ITT population (Change in degree of motion measured as last available post-injection range of motion - baseline range of motion)|||degrees||Standard Deviation|Mean
1247478|NCT00528606|Secondary|Percent Reduction From Baseline Contracture After the First Injection|Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.|Baseline, within 30 days after the first injection|Modified ITT population|||Percent reduction from baseline||Standard Deviation|Mean
1247479|NCT00528606|Secondary|Clinical Improvement After the First Injection|Clinical Improvement is defined as >= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.|Baseline; within 30 days after the first injection|Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percentage of Joints|||Number
1247480|NCT00528606|Secondary|Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection|Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.|Within 30 days after first injection|Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percentage of Joints|||Number
1247481|NCT00528606|Secondary|Time to First Achieve Success After the Last Injection||Last evaluation visit on which clinical success is achieved through the Day 30 evaluation|Modified ITT population|||percentage of joints|||Number
1247482|NCT00528606|Secondary|Change From Baseline Range of Motion After the Last Injection|Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.|Baselin; within 30 days after the last injection|Modified ITT Population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||degrees||Standard Deviation|Mean
1247483|NCT00528606|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.|Baseline; within 30 days after the last injection|Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percent reduction from baseline||Standard Deviation|Mean
1247484|NCT00528606|Secondary|Clinical Improvement After the Last Injection|Clinical Improvement is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection.|Baseline; within 30 days after the last injection|Modified ITT population( Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percentage of Joints|||Number
1247485|NCT00528606|Primary|Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where successfully treated was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.~The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where successfully treated was defined as reduction in contracture to within 0-5° of normal within 30 days of injection."|Within 30 days after the last injection|Modified-Intent-to-Treat population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percentage of Joints|||Number
1247486|NCT00528580|Primary|Time to Clinical Stability|Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.|24 hours||||days||Standard Error|Mean
1247536|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: VT|VT is measured by Body Box Plethysmography, the unit is Liter/Minute.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liters/minute||Standard Deviation|Mean
1247487|NCT00528567|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|Through end of study: 30 June 2014: up to 77 months|Safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all other patients were analyzed in the chemotherapy arm.|||Participants|||Number
1247488|NCT00528567|Secondary|Percentage of Participants With Distant Disease-Free Survival (DDFS) Events|DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
1247489|NCT00528567|Secondary|Time to Distant Disease-Free Survival (DDFS) Event|DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
1247490|NCT00528567|Secondary|Percentage of Participants With Disease-Free Survival (DFS) Events|DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
1247491|NCT00528567|Secondary|Time to Disease-Free Survival (DFS) Event|DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
1247492|NCT00528567|Secondary|Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events|BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
1247493|NCT00528567|Secondary|Time to Breast Cancer-Free Interval (BCFI) Event|BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat participants, defined as all randomized participants.|||Months||95% Confidence Interval|Median
1247494|NCT00528567|Secondary|Percentage of Participants With Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cut off: 30 June 2014: up to 77 months)|Intent-to-treat population, defined as all randomized participants.|||percentage of participants|||Number
1247495|NCT00528567|Primary|Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
1247496|NCT00528567|Secondary|Percentage of Participants With Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cut off: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||percentage of participants|||Number
1247740|NCT00527488|Primary|Time of Testosterone Concentration Below Baseline Interval|The time from when the testosterone concentration falls below the baseline interval limit (i.e. 0.75 x baseline concentration) until it returns above this limit|Day 0-42||||Days||Standard Deviation|Mean
1247497|NCT00528567|Primary|Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
1247498|NCT00528567|Primary|Percentage of Participants With Invasive Disease-free Survival (IDFS) Events|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012 up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
1247499|NCT00528567|Secondary|Time to Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cutoff: 30 June 2014: up to 77 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
1247500|NCT00528567|Secondary|Time to Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
1247501|NCT00528567|Primary|Time to Invasive Disease-free Survival (IDFS) Event|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
1247502|NCT00528541|Secondary|Patient Comparison of Benefit to Previous Injections at Week 10|"Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 10|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this timepoint are included.|||Number of Responses|||Number
1247503|NCT00528541|Secondary|Physician Comparison of Benefit to Previous Injections at Week 10|"Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 10|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this time point are included.|||Number of Responses|||Number
1247504|NCT00528541|Secondary|Patient Visual Analog Assessment of Pain at Week 4|Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Units on a Scale||Full Range|Median
1247505|NCT00528541|Secondary|Patient Assessment of Need for Retreatment at Week 4|"Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?. The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection' and 'does not require injection'."|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at the time points are included.|||Number of Responses|||Number
1247506|NCT00528541|Secondary|Global Assessment of Benefit by Patient at Week 4|Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'|Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Units on a Scale||Full Range|Median
1247507|NCT00528541|Secondary|Global Assessment of Benefit by Physician at Week 4|Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'|Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Units on a Scale||Full Range|Median
1247509|NCT00528541|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4|The TWSTRS assessments were conducted at each study visit. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Scores on a Scale||Full Range|Median
1247510|NCT00528541|Primary|Dysphagia Incidence Over 10 Weeks|Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.|10 weeks|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Number of patients|||Number
1247511|NCT00528528|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)|SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants’ plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.|EOT (up to Week 48) and up to 24 weeks after EOT|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1247512|NCT00528528|Secondary|Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)|Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.|Baseline (pre-dose), EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||log 10 IU/mL||Standard Error|Mean
1247513|NCT00528528|Secondary|Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12|Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.|Baseline (pre-dose), Week 12|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||log 10 IU/mL||Standard Error|Mean
1247514|NCT00528528|Secondary|Percentage of Participants With Partial Response|Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants’ plasma samples).|Baseline (Day 1) up to EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1247515|NCT00528528|Secondary|Number of Participants With Viral Breakthrough at End of Treatment (EOT)|Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.|EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||Participants|||Number
1247516|NCT00528528|Secondary|Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level|Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants’ plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).|Baseline (Day 1) up to EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||Days||Full Range|Median
1247517|NCT00528528|Primary|Percentage of Participants With Virologic Response at Week 12|Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants’ plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).|End of treatment (EOT) (up to Week 48)|Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1247518|NCT00528450|Primary|Molecular Remission Rate|# of patients with Complete Remission|2 years||||participants|||Number
1247519|NCT00528424|Secondary|Change From Baseline Range of Motion After the First Injection|Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion − baseline range of motion|Baseline, Day 30 after first injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Degrees|Joints|Standard Deviation|Mean
1247520|NCT00528424|Secondary|Percent Reduction From Baseline Contracture After the First Injection|Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture.|Baseline, Day 30 after first injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of change|Joints|Standard Deviation|Mean
1247521|NCT00528424|Secondary|Clinical Improvement After the First Injection|Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, within 30 days after first injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of Joints|Joints||Number
1247522|NCT00528424|Secondary|Clinical Success After the First Injection|Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after first injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of Joints|Joints||Number
1247523|NCT00528424|Secondary|Time to Reach Clinical Success|Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories|Within 30 days after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of Joints|Joints||Number
1247524|NCT00528424|Secondary|Change From Baseline Range of Motion After the Last Injection|Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion − baseline range of motion|Baseline, Day 30 after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Degrees|Joints|Standard Deviation|Mean
1247525|NCT00528424|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture.|Baseline, Day 30 after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of change|Joints|Standard Deviation|Mean
1247526|NCT00528424|Secondary|Clinical Improvement After the Last Injection|Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, within 30 days after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of joints|Joints||Number
1247527|NCT00528424|Primary|Reduction in Contracture to 5° or Less|Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of joints|Joints||Number
1247528|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: SpO2|SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Percentage||Standard Deviation|Mean
1247529|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)|SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Percent||Standard Deviation|Mean
1247530|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP|NT-proBNP is measured by clinical lab, the unit is pg/mL.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||pg/ml||Standard Deviation|Mean
1247531|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|NT-proBNP is measured by clinical lab, the unit is pg/mL.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||pg/ml||Standard Deviation|Mean
1247532|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: EF|EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Percent||Standard Deviation|Mean
1247533|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)|EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Percent||Standard Deviation|Mean
1247534|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB|DLCOSB is measured by Body Box Plethysmography, the unit is Percent.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Percent||Standard Deviation|Mean
1247535|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)|DLCOSB is measured by Body Box Plethysmography, the unit is Percent.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Percent||Standard Deviation|Mean
1247741|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: AUCt|Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42|0-42 Days||||ng*day/mL||Standard Deviation|Mean
1247537|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)|VT is measured by Body Box Plethysmography, the unit is Liter/Minute.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liters/minute||Standard Deviation|Mean
1247538|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: RR|RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Breaths/minute||Standard Deviation|Mean
1247539|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)|RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Breaths/minute||Standard Deviation|Mean
1247540|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: VE|VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter/minute||Standard Deviation|Mean
1247541|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)|VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter/minute||Standard Deviation|Mean
1247542|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: RV|RV is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
1247543|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Residual Volume (RV)|RV is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
1247544|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: TLC|TLC is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
1247545|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)|TLC is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
1247546|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: FRC|FRC is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
1247547|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)|FRC is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
1247548|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75|FEF25-75 is measured by Spirometry, the unit is Liter/Second.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter/second||Standard Deviation|Mean
1247549|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)|FEF25-75 is measured by Spirometry, the unit is Liter/Second.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter/second||Standard Deviation|Mean
1247550|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio|FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Ratio||Standard Deviation|Mean
1247551|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)|FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Ratio||Standard Deviation|Mean
1247552|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FVC|FVC is measured by Spirometry, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
1247553|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)|FVC is measured by Spirometry, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
1247554|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FEV1|FEV1 is measured by Spirometry, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
1247555|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is measured by Spirometry, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
1247556|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|240 hours - Day 10 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247557|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|168 hours - Day 7 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247558|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|120 hours - Day 5 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247559|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|72 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247560|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|48 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247561|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|24 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247562|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|8 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247563|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|4 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247564|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|2 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247565|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|0 hour before last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247566|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|24 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247567|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|8 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247568|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|4 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247569|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|1 hour after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247570|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|0.5 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247571|NCT00528411|Primary|Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug|IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.|4 to 72 Hours after last dose of study drug|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage/Hour||Standard Error|Least Squares Mean
1247572|NCT00528411|Primary|Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|At 2 hours after first dose of study drug|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
1247573|NCT00528398|Secondary|Bone Marrow at Day 7 Post-Induction Chemotherapy|Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)|7 days post completion of induction chemotherapy||||Participants|||Count of Participants
1247574|NCT00528398|Primary|Complete Remission (CR)|The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.|7 days post completion of induction chemotherapy||||Participants|||Count of Participants
1247575|NCT00528372|Secondary|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])|12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants who received at least 1 dose of study medication and who had measurements available|||Participants|||Number
1247576|NCT00528372|Secondary|Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)|Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Day 1 to Week 102 (end of Long-term Period)|Randomized participants who received at least 1 dose of study medication and with laboratory test results available|||Participants|||Number
1247601|NCT00528112|Secondary|Degree of User Overall Satisfaction With Study Treatment|Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.|At the end of study/Year 3|All participants from the full analysis set who had an assessment for this evaluation|||Participants|||Number
1247577|NCT00528372|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)|Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66.|Baseline to Week 102 (end of Long-term Period)|Randomized participants who received at least 1 dose of study medication and with laboratory test results available|||Participants|||Number
1247578|NCT00528372|Primary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2|HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values|||Percent||Standard Deviation|Mean
1247579|NCT00528372|Secondary|Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.|Day 1 to Week 102 (end of Long-term Period) + 30 days|Randomized participants who received at least 1 dose of study medication|||Participants|||Number
1247580|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with baseline BMI ≥27 kg/m^2 and nonmissing baseline and Week 24 values|||Kilograms||Standard Error|Mean
1247581|NCT00528372|Secondary|Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c values at both baseline and Week 24 (LOCF)|||Percentage of participants|||Number
1247582|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with baseline BMI ≥27 kg/m^2 and nonmissing baseline and Week 24 LOCF values|||Percent||Standard Error|Mean
1247602|NCT00528112|Secondary|Classification of Endometrium – Year 3 / End of Study|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 3 / End of study|A subset of women from the full analysis set|||Participants|||Number
1247603|NCT00528112|Secondary|Classification of Endometrium – Year 2|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 2|A subset of women from the full analysis set|||Participants|||Number
1247604|NCT00528112|Secondary|Classification of Endometrium – Year 1|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 1|A subset of women from the full analysis set|||Participants|||Number
1247583|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c >9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week24 LOCF values.|||Percent||Standard Error|Mean
1247584|NCT00528372|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants who had nonmissing baseline and Week 24 LOCF values|||Percentage of participants|||Number
1247585|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline to Week 1|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment with nonmissing baseline and Week 24 LOCF values|||mg/dL||Standard Deviation|Mean
1247586|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline to Week 1 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values|||mg/dL||Standard Error|Mean
1247587|NCT00528372|Secondary|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.|From Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment nonmissing baseline and Week 24 LOCF values.|||Kilograms||Standard Deviation|Mean
1247588|NCT00528372|Secondary|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 values|||Kilograms||Standard Error|Mean
1247605|NCT00528112|Secondary|Average Total Cervical Score – Year 3|Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)|For six weeks in the second half of Year 3|A subset of women from the full analysis set|||Scores on a scale||Standard Deviation|Mean
1247606|NCT00528112|Secondary|Average Total Cervical Score – Year 2|"Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.~Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)"|For six weeks in the second half of Year 2|A subset of women from the full analysis set|||Scores on a scale||Standard Deviation|Mean
1247589|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2|Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values|||mg/dL||Standard Deviation|Mean
1247590|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values|||mg/dL||Standard Error|Mean
1247591|NCT00528372|Primary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1|HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values|||Percent||Standard Error|Mean
1247592|NCT00528268|Secondary|The Study Will Determine Potential Benefit of NaPB on Lean Body Mass; Overall Motor Function; Potential Cellular Response to NaPB; and Drug Compliance.||24 months|||||||
1247593|NCT00528268|Primary|The Study Will Assess the Safety, Tolerability and Potential Efficacy of Sodium Phenylbutyrate (NaPB) in Presymptomatic Infants Genetically Confirmed to Have SMA. It Will Also Determine Selected Pharmacokinetic Parameters.|Number of participants with SAE's related to research.|24 months||||participants|||Number
1247594|NCT00528190|Primary|The Primary Outcome Measure Will be the Number of Patients Who Experience a Respiratory Exacerbation Requiring Intravenous Antibiotics in the Two Treatment Groups Over the 24 Week Trial Treatment Period.|The Primary outcome measure will be the number of patients who experience a respiratory exacerbation requiring intravenous antibiotics in the two treatment groups over the 24 week trial treatment period.|24 weeks||||Participants|||Count of Participants
1247595|NCT00528112|Secondary|Number of Participants With Partial or Total Expulsion up to 5 Years|If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.|Up to 5 years|All participants from the full analysis set who had an assessment for this evaluation|||Participants|||Number
1247596|NCT00528112|Secondary|Degree of User Overall Satisfaction With Study Treatment up to 5 Years|Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.|At the end of study/Year 5|All participants from the full analysis set who participated in the extension phase and had an assessment for this evaluation|||Participants|||Number
1247597|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1711 to Day 1800|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247598|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1081 to Day 1170|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247599|NCT00528112|Primary|Pearl Index for LCS16 up to 5 Years|The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.|Up to 5 years|Full analysis set|||Pregnancies per 100 women years||95% Confidence Interval|Number
1247600|NCT00528112|Secondary|Number of Participants With Partial or Total Expulsion|If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.|Up to 3 years|All participants from the full analysis set who had an assessment for this evaluation|||Participants|||Number
1247607|NCT00528112|Secondary|Average Total Cervical Score – Year 1|Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)|For six weeks in the second half of Year 1|A subset of women from the full analysis set|||Scores on a scale||Standard Deviation|Mean
1247608|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 3|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 3|A subset of women from the full analysis set|||Participants|||Number
1247609|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 2|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 2|A subset of women from the full analysis set|||Participants|||Number
1247610|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 1|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 1|A subset of women from the full analysis set|||Participants|||Number
1247611|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 331 to Day 360|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247612|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 91 to Day 120|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247613|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 61 to Day 90|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247614|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 31 to Day 60|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247615|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1 to Day 30|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247616|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 991 to Day 1080|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247617|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 271 to Day 360|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247618|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 181 to Day 270|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247619|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 91 to Day 180|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247620|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1 to Day 90|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
1247621|NCT00528112|Primary|Pearl Index up to 3 Years|The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.|Up to 3 years|Full analysis set|||Pregnancies per 100 women years||95% Confidence Interval|Number
1247622|NCT00528021|Primary|Clinical Cure|No live lice 14 days following last treatment|Day 15 or 22||||participant|||Number
1247623|NCT00527982|Primary|Histological Responses|Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.|Baseline to 12 months|No analysis. One registered patient inevaluable for response, study terminated early.||||||
1247639|NCT00527878|Secondary|Clinical Severity Score|Scoring that was completed every 3 months. Clinical severity scored had outcomes that could range from 0 to 121 with 0 being the least severe and 121 being the most severe.|one year on ranitidine and one year on placebo|Patients who completed the study|||score on a scale||Full Range|Mean
1247624|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247625|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247626|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247627|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of RIR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced RIR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm|||Percentage of Participants|||Number
1247628|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247629|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization|The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247630|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: all-cause death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause Death, MI, stroke, or UCR I within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247631|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: all-cause death, MI, stroke, RIR, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause death, MI, stroke, RIR, or UCR within 2 years from randomization.|Up to 2 years|Intent to Treat population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247640|NCT00527878|Secondary|New Lung Infections|Number of new infection while on placebo or study drug|12 months placebo and 12 months ranitidine|Patients who completed the study|||new lung infections||Full Range|Median
1247641|NCT00527878|Secondary|New Skin Infections|Patients reported the number of new skin infections|12 months placebo/12 months ranitidine|Patients that completed the study|||skin infections||Full Range|Median
1247632|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or MI Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247633|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247634|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 2 years from randomization.|Up to 2 years|As Treated Population, which included all participants who received at least 1 dose of study medication.|||Percentage of Participants|||Number
1247635|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 2 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 2 years from randomization.|Up to 2 years|As Treated Population, which included all participants who received at least 1 dose of study medication.|||Percentage of Participants|||Number
1247636|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), and/or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the secondary composite efficacy endpoint within 2 years from randomization.|up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247637|NCT00527943|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), stroke, recurrent ischemia with re-hospitalization (RIR), and/or urgent coronary revascularization (UCR). A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the primary composite efficacy endpoint within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247638|NCT00527904|Primary|Number of Subjects Monitored for Long-term Safety of PN 400|Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window.|12 months|Approximately 200 subjects were planned, 239 were enrolled and treated and 143 subjects completed the study. All 239 subjects were evaluable for safety.|||participants|||Number
1247642|NCT00527878|Primary|Number of Infections in Subjects With HIES.|Patients received one year of treatment medication and one year of placebo. New infections (bacterial, fungal, viral or parasitic) were defined as those requiring an addition or change of an antimicrobial (including topical, oral or intravenous therapies) or those requiring a medical procedure (i.e., incision and drainage of a skin abscess, warm soaks to aid abscess drainage or sinus drainage).|1 year on intervention|Patients that completed both arms of the study (24 months)|||infections||Full Range|Median
1247643|NCT00527826|Secondary|Mean Total Costs (Related to COPD) Per Participant|"Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used as required were assumed to be used every second day."|Baseline through Week 52|ITT Population|||Euros per participant||Standard Deviation|Mean
1247644|NCT00527826|Secondary|Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population|||percent||Standard Deviation|Mean
1247645|NCT00527826|Secondary|Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population|||percent||Standard Deviation|Mean
1247646|NCT00527826|Secondary|Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population|||percent||Standard Deviation|Mean
1247647|NCT00527826|Secondary|Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population|||percent||Standard Deviation|Mean
1247648|NCT00527826|Secondary|Mean Change From Baseline in the Tiffeaneau Index at Week 52|The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline.|Baseline and Week 52|ITT Population|||percent of IVC||Standard Deviation|Mean
1247649|NCT00527826|Secondary|Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52|Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented.|Baseline and Week 52|ITT Population|||liters||Standard Deviation|Mean
1247650|NCT00527826|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52|Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented.|Baseline and Week 52|ITT Population|||percent of predicted value||Standard Deviation|Mean
1247651|NCT00527826|Secondary|Mean Number of Days Rescue Medication Was Used|Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.|The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])|ITT Population with non-missing data (due to early withdrawal, some data for this outcome measure are missing).|||number of days||Standard Deviation|Mean
1247652|NCT00527826|Secondary|Number of Participants With the Indicated Number of Hospital Stays|The number of participants with the indicated number of hospitalizations was recorded.|Baseline through Week 52|ITT Population|||participants|||Number
1247653|NCT00527826|Secondary|Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)|The number participants with the indicated number of days at the ICU was recorded.|Baseline through Week 52|ITT Population of participants who were admitted to the ICU|||participants|||Number
1247654|NCT00527826|Secondary|Mean Number of COPD-related Visits at/by Physician|The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up.|Baseline through Week 52|ITT Population with non-missing data (due to early withdrawal some data for this outcome measure are missing)|||number of visits||Standard Deviation|Mean
1247655|NCT00527826|Primary|Mean Number of Exacerbations Per Year: Poisson Model|During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.|Baseline through Week 52|ITT Population|||Number of exacerbations per year||Standard Error|Least Squares Mean
1247656|NCT00527826|Secondary|Compliance and Adherence to Study Medication|Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.|Baseline through Week 52|ITT Population|||percentage of doses||Standard Deviation|Mean
1248126|NCT00524745|Secondary|Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months||||GMT ratio||95% Confidence Interval|Number
1247657|NCT00527826|Primary|Mean Number of Exacerbations Per Year: Negative Binomial Model|During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.|Baseline through Week 52|Intent-to-Treat (ITT) Population: all participants receiving at least one dose of study medication and suffering from COPD|||Number of exacerbations per year||Standard Error|Least Squares Mean
1247658|NCT00527787|Secondary|Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales|Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
1247659|NCT00527787|Secondary|Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales|Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
1247660|NCT00527787|Secondary|Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales|"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47"|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
1247661|NCT00527787|Secondary|Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire|"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group."|change from baseline at 6 Months|Intent to Treat (ITT) Population|||Participants|||Number
1247662|NCT00527787|Secondary|Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population|||participants|||Number
1247663|NCT00527787|Secondary|The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment|The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period|6 months|Intent to treat (ITT) population|||Participants|||Number
1247664|NCT00527787|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer|The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period|6 Months|Intention to Treat (ITT) Population|||Participants|||Number
1247665|NCT00527787|Secondary|The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers|The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort|6 months|Intent to Treat (ITT) Population|||Participants|||Number
1247666|NCT00527787|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population|||Participants|||Number
1247667|NCT00527748|Primary|Change in Range of Motion|Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy.|Ten weeks|No participant data or results are available as the investigator left the institution without making them or any analysis available.||||||
1247668|NCT00527735|Secondary|Overall Survival in Participants With SCLC|Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.|Randomization date to date of death (of censored, maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.|||Months||95% Confidence Interval|Median
1247669|NCT00527735|Secondary|Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline|An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.|Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|Participants with SCLC who had at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.|||Participants|||Number
1247670|NCT00527735|Secondary|Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings|Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.|Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.|||Participants|||Number
1247671|NCT00527735|Secondary|Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria|By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.|Randomization date to date of progression or death (of censored, maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.|||Months||95% Confidence Interval|Mean
1247672|NCT00527735|Secondary|Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade|ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN. Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study pancreatic enzyme or other laboratory test measurement available.|||Percentage of participants|||Number
1247673|NCT00527735|Secondary|Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade|ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study liver function test result available.|||Participants|||Number
1247674|NCT00527735|Secondary|Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade|CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study hematology test result available.|||Participants|||Number
1247675|NCT00527735|Secondary|Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)|All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.|||Participants|||Number
1247676|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline|An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.|Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.|||Participants|||Number
1247677|NCT00527735|Secondary|Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade|ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study pancreatic enzyme laboratory test measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Percentage of participants|||Number
1247678|NCT00527735|Secondary|Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings|Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.|At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Participants|||Number
1247679|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade|ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study liver function measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Participants|||Number
1247680|NCT00527735|Secondary|irPFS in Participants With SCLC Per irRC|IRC performed TA.|Randomization date to date of irPD or death (maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.|||Months||95% Confidence Interval|Mean
1247681|NCT00527735|Secondary|Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade|CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study hematology test result available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Percentage of participants|||Number
1247682|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)|All participants with NSCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Participants|||Number
1247683|NCT00527735|Secondary|Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC|irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.|Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)|All participants who were randomized to a treatment group.|||Months||95% Confidence Interval|Median
1247684|NCT00527735|Secondary|Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC|irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)|All participants who were randomized to a treatment group.|||Percent of participants||95% Confidence Interval|Number
1247685|NCT00527735|Secondary|Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)|irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance|All participants who were randomized to a treatment group.|||Percentage of participants||95% Confidence Interval|Number
1247742|NCT00527488|Primary|Testosterone Area Below Baseline Interval|The area of the testosterone concentration (ng/mL) vs. time (days) curve that is below the baseline interval concentration( i.e. 0.75 x baseline concentration)|0-42 Days||||ng*days/mL||Standard Deviation|Mean
1247686|NCT00527735|Secondary|Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC|mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance|All participants who were randomized to a treatment group.|||Percentage of participants||95% Confidence Interval|Number
1247687|NCT00527735|Secondary|Overall Survival in Participants With NSCLC|Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.|Randomization date to date of death (of censored, maximum reached: 26.5 months)|All NSCLC participants who were randomized to a treatment group.|||Months||95% Confidence Interval|Median
1247688|NCT00527735|Secondary|Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria|By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.|Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)|All NSCLC participants who were randomized to a treatment group.|||Months||95% Confidence Interval|Mean
1247689|NCT00527735|Primary|Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)|irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.|Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)|All participants with NSCLC who were randomized to a treatment group.|||Months||95% Confidence Interval|Median
1247690|NCT00527722|Primary|Number of Participants With Absence of Pneumothoraces|Treatment Success defined as absence of pneumothoraces to measure the effects of the hydrogel plug in three follow-up radiographic assessment (x-rays post procedure by 0-60 minutes, 24 hours and 30 days).|X-Rays at 0-60 minutes, 24 hours and 30 days|Intent-to-treat (ITT) population of all subjects who were randomized.|||Participants|||Number
1247691|NCT00527644|Secondary|Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security.||By post op day one HIDA scan.|Data not collected.||||||
1247692|NCT00527644|Primary|No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.||By post op day one HIDA scan.||||Participants|||Count of Participants
1247693|NCT00527618|Secondary|Sub-Study: To Evaluate the Kinetics of Plasma HIV-1 Decline Over the First Three Days of High-dose Valacyclovir Administration.|Plasma HIV-1 RNA was measured one day prior to, at initiation, and at 6, 24, 48, and 72 hours after initiating valacyclovir. Measurements at 24, 48, and 72 hours were used to determine the rate of HIV-1 RNA decline.|72 hours|In April 2010, we invited participants, including those who already completed the study, to participate in the substudy. Two participants had plasma HIV-1 RNA <40 copies/mL at the time of valacyclovir initiation and were excluded from analysis.|||log10 copies/mL/day||95% Confidence Interval|Mean
1247694|NCT00527618|Secondary|The Effect of Valacyclovir 1 g Twice Daily Compared With Acyclovir 400 mg Twice Daily on the Quantity of Genital HSV Detected During Shedding Episodes.|HSV DNA was quantitated from daily self-collected genital swabs for the four weeks of each drug intervention. The quantity of genital HSV DNA present, when HSV DNA was detected, was compared.|The first four weeks of each intervention|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.|||log10 copies/mL||Full Range|Median
1247695|NCT00527618|Secondary|The Effect of Valacyclovir 1 Gram Twice Daily Compared to Acyclovir 400 mg Twice Daily on the Percentage of Days With Genital Herpes Lesions.|The percentage of days with genital herpes lesions was determined by the combined diary days in which genital lesions were recorded divided by the combined number of diary days for participants in the first four weeks of each drug intervention, multiplied by 100.|26 weeks (12 weeks per drug intervention)|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.|||percentage of days with genital lesions|||Number
1247696|NCT00527618|Primary|The Genital HSV Shedding Rate While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.|HSV DNA quantitated from daily self-collected genital swabs for the first four weeks of each drug intervention. The shedding rate was determined by the combined number of swabs with HSV detected divided by the combined number of swabs collected from participants, multiplied by 100.|The first four weeks of each intervention|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.|||percentage of swabs collected with HSV|||Number
1247713|NCT00527605|Primary|Percent Change From Baseline in the Prostate Volume at Month 6|Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment (after the 4-week placebo run-in) and received at least one dose of study treatment. Some participants were missing Month 6 measurements.|||percent change in volume||Standard Deviation|Mean
1247761|NCT00527332|Secondary|Complications and Complication Rates.||Within 6 months after the surgery|||||||
1247697|NCT00527618|Primary|The Quantity of HIV-1 RNA in Plasma While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.|Weekly measurements of plasma HIV-1 RNA on each drug were compared. The primary analysis was of the average difference in plasma HIV-1 RNA on valacyclovir and acyclovir as determined by a linear mixed model. The median of the average per-participant plasma HIV-1 RNA levels on valacyclovir and valacyclovir is also listed.|26 weeks (12 weeks per drug intervention)|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants. 27 participants had plasma HIV-1 RNA levels available for analysis, since samples for one participant were persistently inhibited.|||log10 copies/mL||Full Range|Median
1247698|NCT00527605|Secondary|Change From Baseline in Qmax at Month 3|Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||ml/s||Standard Deviation|Mean
1247699|NCT00527605|Secondary|Change From Baseline in Qmax at Month 6|Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||milliliters/second (ml/s)||Standard Deviation|Mean
1247700|NCT00527605|Secondary|Percent Change From Baseline in Qmax at Month 3|Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||percent change||Standard Deviation|Mean
1247701|NCT00527605|Secondary|Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6|Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||percent change||Standard Deviation|Mean
1247702|NCT00527605|Secondary|Change From Baseline in the AUA-SI Score at Month 3|Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||points on a scale||Standard Deviation|Mean
1247703|NCT00527605|Secondary|Change From Baseline in the AUA-SI Score at Month 6|Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||points on a scale||Standard Deviation|Mean
1247704|NCT00527605|Secondary|Percent Change From Baseline in the AUA-SI Score at Month 3|Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||percent change||Standard Deviation|Mean
1247705|NCT00527605|Secondary|Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6|Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||percent change||Standard Deviation|Mean
1247706|NCT00527605|Secondary|Change From Baseline in the Serum DHT at Month 3|Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||pg/ml||Standard Deviation|Mean
1247707|NCT00527605|Secondary|Change From Baseline in the Serum DHT at Month 6|Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||picograms/milliliter (pg/ml)||Standard Deviation|Mean
1247708|NCT00527605|Secondary|Percent Change From Baseline in the Serum DHT at Month 3|Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||percent change||Standard Deviation|Mean
1247709|NCT00527605|Secondary|Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6|Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||percent change||Standard Deviation|Mean
1247710|NCT00527605|Secondary|Change From Baseline in the Prostate Volume at Month 3|Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||cubic centimeters||Standard Deviation|Mean
1247711|NCT00527605|Secondary|Change From Baseline in the Prostate Volume at Month 6|Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||cubic centimeters||Standard Deviation|Mean
1247712|NCT00527605|Secondary|Percent Change From Baseline in the Prostate Volume at Month 3|Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||percent change in volume||Standard Deviation|Mean
1247714|NCT00527592|Primary|Comfort Immediately After Dosing|Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.|5 seconds|Intent to treat: All patients who received test article and completed the trial.|||Units on a scale|Participants|Standard Deviation|Mean
1247715|NCT00527566|Secondary|Efficacy- Exacerbation Rate|Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis.|Treatment period (12 weeks)||||Exacerbation rate (Exacerbations/day)|||Number
1247716|NCT00527566|Primary|Number of Participants Who Experienced Specific Symptoms|Number of participants who experienced specific symptoms during the trial.|44 weeks||||Participants|||Number
1247717|NCT00527566|Secondary|Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims|The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7.|20 weeks||||units on a scale||Full Range|Mean
1247718|NCT00527566|Secondary|Steroid Dosing During Trial||20 weeks||||Prednisone mg/day||Full Range|Mean
1247719|NCT00527566|Primary|Number of Participants With Indicated Side Effects|Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.|Participants were followed for the duration of the study, approximately 44 weeks||||Participants|||Number
1247720|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end end of week 12|ITT (efficacy cohort)|||mm Hg||Standard Error|Mean
1247721|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 9|ITT (efficacy cohort)|||mm Hg||Standard Error|Mean
1247722|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 6|ITT (efficacy cohort)|||mm Hg||Standard Error|Mean
1247723|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 3|ITT (efficacy cohort)|||mm Hg||Standard Deviation|Mean
1247724|NCT00527514|Secondary|Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure||Baseline to 12 weeks|The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.|||mm Hg||Standard Deviation|Mean
1247725|NCT00527514|Primary|Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring||Baseline to 12 Weeks|The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.|||mm Hg||Standard Deviation|Mean
1247726|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: Tmax|The time for maximal concentration (tmax) was determined for data up to Day 42|Day 0-42||||Days||Standard Deviation|Mean
1247727|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: Cmax|Cmax was determined for concentration measurements up to Day 42|Day 0-42||||ng/mL||Standard Deviation|Mean
1247728|NCT00527488|Primary|Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction|The IIEF contains 15 items in 5 domains: Erectile Function (6 items), Orgasmic Function (2 items), Sexual Desire (2 items), Intercourse Satisfaction (3 items), and Overall Satisfaction (2 items). Item are scored on a scale from ‘No sexual activity’ to ‘Almost always to always’. For the Erectile Function domain, a score of 1-10 indicates severe erectile dysfunction and 26-30 no dysfunction, the minimum score being 1 and the maximum 30. For all other domains, a higher score indicates less dysfunction. The IIEF does not yield a total score.|Day 0-42||||Units on a scale||Standard Deviation|Mean
1247729|NCT00527488|Primary|IPSS Global Quality of Life|"Patients were asked about how they would feel if they were to spend the rest of their lives with their prostate symptoms just as they are now. The answers choices range from delighted to terrible or 0 to 6."|Day 0-42||||Units on a scale||Standard Deviation|Mean
1247730|NCT00527488|Primary|International Prostate Specific Symptom (IPSS) Score|The IPSS is a patient-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (0-7: mildly symptomatic; 8-19: moderately symptomatic; 20-35: severely symptomatic).|Day 0-42||||Units on a scale||Standard Deviation|Mean
1247731|NCT00527488|Primary|Post-void Residual Urine Volume|The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically.|Day 0-42||||mL||Full Range|Mean
1247732|NCT00527488|Primary|Maximal Urinary Flow|Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.|Day 0-42||||mL/s||Standard Deviation|Mean
1247733|NCT00527488|Primary|Prostate Volume|The prostatic volume was measured by transrectal ultrasound. The prostatic gland was sonicated from two directions perpendicular to one another resulting in three cursor positions set by the urologist, and the volume automatically calculated.|Day 0-42||||mL||Standard Deviation|Mean
1247734|NCT00527488|Primary|Prostate Specific Antigen (PSA) Concentration||Day 0-42||||ng/mL||Standard Deviation|Mean
1247762|NCT00527332|Secondary|Postoperative Consumption of Analgesics and Antiemetics.||Within 6 months after surgery|||||||
1247743|NCT00527475|Secondary|The Number of Days to Retreatment. The Total Number of Treatments Given Over One Year. The Percentage of Patients With More Than a 15 Letter Increase in Vision at 12 Months. The Mean Change in Macular Volume as Measured by OCT at 3, 6, and 12 Months.||1 year|||||||
1247744|NCT00527475|Primary|The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.||1 year|Fifty-six participants completed the full 12 month study. Four subjects did not return for the 12 month visit. No patients terminated the study due to adverse events.|||percentage of participants|||Number
1247745|NCT00527423|Secondary|Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline of original study to Wk 156||||letters read||Standard Deviation|Mean
1247746|NCT00527423|Secondary|Frequency (Number of Injections)|Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).|Baseline of this study to Wk 152|A total of 1116 PRN injections were administered into the study eyes of 135 participants between baseline of this study to Week 152 (end of treatment). Of the 157 enrolled participants, 22 received no injections, and 15 received 1 injection.|||Injections||Full Range|Median
1247747|NCT00527423|Primary|Number of Participants With Adverse Events (AE)|Number of participants with AEs summarized by category|Baseline of this study to Wk 152||||participants|||Number
1247748|NCT00527397|Primary|Self-Monitoring Blood Glucose Levels: Change From Baseline|Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.|One year|This endopoint was not analyzed because of small numbers of subjects due to early termination|||milligram/millilitre||Standard Deviation|Mean
1247749|NCT00527397|Secondary|Insulin Antibody Levels : Change From Baseline|Insulin antibody levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, End of treatment|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||microunit/milliliter||Standard Deviation|Mean
1247750|NCT00527397|Secondary|The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline|Pulmonary function test(forced expiratory volume at 1 second/forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.|||liter/liter||Standard Deviation|Mean
1247751|NCT00527397|Secondary|The Values of Forced Vital Capacity:Change From Baseline|pulmonary function test(forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.|||liter||Standard Deviation|Mean
1247752|NCT00527397|Secondary|The Values of Forced Expiratory Volume at 1 Second:Change From Baseline|Pulmonary function test(forced expiratory volume at 1 second) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Beseline, Week 1, Week 2, Week 6, Week 12, Week 26|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.|||liter||Standard Deviation|Mean
1247753|NCT00527397|Secondary|The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin|Number of hypoglycemic events per subject-month. Subject-month=(number of days from the first day of study treatment to the last day of active treatment + 1 day lag)/30.44|0 month to 12 months|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||events / subject-month|||Number
1247754|NCT00527397|Secondary|The Value of Fasting Plasma Glucose:Change From Baseline|Fasting plasma glucose levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, Week 26|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||milligram/millilitre||Standard Deviation|Mean
1247755|NCT00527397|Secondary|The Values of Hemoglobin A1c:Change From Baseline|Hemoglobin A1c levels obtained each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, Week 26, End of treatment|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||percent||Standard Deviation|Mean
1247756|NCT00527397|Secondary|Daily Inhaled Insulin Dose|The mean of daily inhaled insulin dose. The dose of inhaled insulin was adjusted based on the results of self-monitoring of blood glucose before each meal.The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Up to 26 weeks|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||milligram||Standard Deviation|Mean
1247757|NCT00527332|Secondary|Health-related Economy.||Within 6 months after the surgery|||||||
1247758|NCT00527332|Secondary|The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.||Within 6 months after the surgery|||||||
1247759|NCT00527332|Secondary|Sick Leave.||Within 6 months after the surgery|||||||
1247760|NCT00527332|Secondary|Quality of Life and QALYs (Quality Adjusted Life Years).||Within 6 months after the surgery|||||||
1247767|NCT00527124|Secondary|Overall Survival|Analyzed with standard K-M methodology. A 12 month survival rate will be calculated since median survival was not reached by the end of the study period.|The time from registration date until death from any cause, assessed up to 52 weeks||||percentage of patients||95% Confidence Interval|Number
1247768|NCT00527124|Secondary|Time to Progression|Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm.|The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks||||months||95% Confidence Interval|Median
1247769|NCT00527124|Secondary|Overall Response Rate Evaluated by the RECIST Criteria|"The overall response is determined by combining the patient’s status on target lesions, PSA, non-target lesions, and new disease as defined in the following table.~Target Lesions CR CR PR SD PD Any Any Any~PSA Response CR PR PR Non-PD Any Any PD Any~Non-Target Lesions CR Non-CR/Non-PD Non-PD Non-PD Any PD Any Any~New Lesions No No No No Yes or No Yes or No Yes or No Yes~Overall Response CR PR PR SD PD PD PD PD"|Up to 52 weeks||||proportion of evaluable patients||95% Confidence Interval|Number
1247770|NCT00527124|Secondary|Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group|PSA < 4.0 ng/ml. is a CR. A 50% decline or better in PSA is a PR. Less than a 50% decline in PSA and less than a 25% increase in PSA is SD. A 25% or greater increase in PSA level by at least 5 ng/mL is PD by PSA only. The point estimate and 95% Wilson CI estimates of the proportion for the Prostate-specific antigen (PSA) response will be computed .|Up to 52 weeks||||proportion of evaluable patients||95% Confidence Interval|Number
1247771|NCT00527124|Primary|6-month Progression-free Survival (PFS) Proportion|The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free|Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months|Per protocol. 30 subjects on Arm I and 28 subjects on Arm II accrued for analysis of the primary endpoint of 6 mths PFS proportion. PFS is obtainable on all 58 participants enrolled, however 1 subject enrolled on Arm I withdrew before receiving any treatment, hence cannot be included for AE analysis and reporting, AE results involve 29 subjects.|||percentage of patients||95% Confidence Interval|Number
1247772|NCT00527111|Secondary|KRAS Mutation Rate|Percentage of Participants with KRAS mutation.|5 years|ITT population with KRAS test|||percentage of participants with mutation|||Number
1247773|NCT00527111|Secondary|Recurrence-free Survival (RFS) Rate at 5 Years|RFS is measured from the date of randomization to the date of first documented disease recurrence or date of death, whichever comes first. If a patient neither recurrences nor dies, this patient will be censored at the date of last contact.|5 years|ITT population|||probability of recurrence-free survival||95% Confidence Interval|Number
1247774|NCT00527111|Secondary|5- Year Overall Survival (OS) Rate|Overall survival is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.|5 years|ITT population|||probability of overall survival||95% Confidence Interval|Number
1247775|NCT00527111|Secondary|To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|5 years|Evaluable Population|||percentage of participants||95% Confidence Interval|Number
1247776|NCT00527111|Primary|Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.|A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes.|5 years|Post surgery population|||percentage of participants||95% Confidence Interval|Number
1247777|NCT00527098|Primary|Mortality||From hospital arrival up to an average of 3.5 weeks|Analysis was per protocol.|||participants|||Number
1247778|NCT00527072|Secondary|Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26||Week 26|This analysis is based on all observed mITT patients. The treatment failures will be classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, their data at that visit will not be imputed.|||participants|||Number
1247779|NCT00527072|Secondary|Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10|A PASI 50 responder is defined as a patient who has achieved at least a 50% improvement in the overall PASI score from baseline. PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A score less than 10 signifies a mixture of mild and moderate disease; a score greater than 10 but less than or equal to 30 signifies moderate disease; and a score greater than 30 signifies severe disease.|Week 10|Analysis is based on observed mITT (modified Intent to Treat) patients. Treatment failures are classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, will not have data imputed at that visit.|||participants|||Number
1247780|NCT00527072|Primary|Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0)|Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).|Week 10|This analysis is based on the evaluable population that includes the all enrolled patients who received at least one infliximab infusion, and had a baseline PGA score greater than 1.|||participants|||Number
1247832|NCT00526591|Secondary|Change in PSA|Time-to-event data, such as change in PSA will be summarized using the method of Kaplan and Meier.|Up to 16 weeks after start of study|One patient in the high dose cohort was not analyzed for change in PSA because they withdrew early due to progressive disease|||ng/mL||Inter-Quartile Range|Median
1247833|NCT00526591|Primary|Toxicity Profile of Each Dose (Number of Patients With Worst Grade Toxicity)|Toxicity will be assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAEv3.0)|at daily dose for 8 weeks|intention to treat|||participants|||Number
1247781|NCT00526994|Primary|Quality of Life, Mental Health Composite|Assessed with the Quality of Life SF-12 v.2 (Ware, Kosinski, Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.|past 30 days||||units on a scale||95% Confidence Interval|Mean
1247782|NCT00526994|Secondary|Disability|days lost from housework|one year follow-up||||days||95% Confidence Interval|Mean
1247783|NCT00526994|Secondary|Utilization of Health Care|number of ambulatory care visits|during past year||||visits||95% Confidence Interval|Mean
1247784|NCT00526994|Primary|Quality of Life, Physical Health Composite|Assessed with Quality of Life SF-12 V.2 (Ware, Kosinski,Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.|at one-year follow-up||||units on a scale||95% Confidence Interval|Mean
1247785|NCT00526890|Secondary|Selenium Level by Incidence of SAE|Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.|Pre-treatment and every week for 6 weeks prior to chemotherapy.|All treated and eligible patients|||ng/mL||Full Range|Median
1247786|NCT00526890|Secondary|Overall Survival||Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter|Patients treated with study therapy|||months||95% Confidence Interval|Median
1247787|NCT00526890|Secondary|Failure-free Survival||Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.|Patients treated with study therapy|||months||95% Confidence Interval|Median
1247788|NCT00526890|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 month post-treatment, then q 3 months x 4||||percentage of patients||95% Confidence Interval|Number
1247789|NCT00526890|Primary|Incidence of Grade 3-4 Myelosuppression||During study treatment, up to 6 weeks|Patients Treated with Study Therapy|||percentage of participants||95% Confidence Interval|Number
1247790|NCT00526890|Primary|Incidence of Grade 3-4 Pneumonitis||During study treatment, up to 6 weeks|Patients treated with study therapy|||percentage of participants||95% Confidence Interval|Number
1247791|NCT00526890|Primary|Incidence of Grade 3-4 Esophagitis||During study treatment, up to 6 weeks|Treated with Study Therapy|||percentage of participants||95% Confidence Interval|Number
1247792|NCT00526799|Secondary|Duration of Stable Disease|To determine duration of stable disease, in months|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely||||months||95% Confidence Interval|Median
1247793|NCT00526799|Secondary|Clinical Benefit|To determine the rate of clinical benefit defined as the percentage of patients experiencing an objective response or a CA125 response.|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely||||percentage of particpants||95% Confidence Interval|Number
1247794|NCT00526799|Secondary|Progression-free Survival|To determine the progression-free survival of patients treated with Sorafenib plus Topotecan.|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely||||months||95% Confidence Interval|Median
1247795|NCT00526799|Primary|Percentage of Participants With Response|"To assess response in patients with recurrent or resistant epithelial ovarian cancer treated with Sorafenib plus Topotecan. Reponse evaluated per RECIST criteria where:~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|Disease assessments were conducted on the 8th week (Cycle 2, Week 4) and every eight weeks there after, until treatment discontinuation||||percentage of participants|||Number
1247796|NCT00526799|Primary|Maximum Tolerated Dose (MTD)|An initial 3 patients will be enrolled at dose level 1. If all 3 patients in dose level 1 complete the first cycle of therapy without a dose limiting toxicity (DLT), 3 patients will be enrolled at dose level 2. If 0 of 3 or 1 of 6 patients in dose level 2 experience a DLT, all subsequent patients will be enrolled in the Phase II cohort at dose level 2. If 2 of the first 3 or 2 of the total 6 patients experience DLT at dose level 2, then dose level 1 will be considered the MTD and used in the second phase.|Each participant was treated at their assigned dose level on 28 day cycles until disease progression or unacceptable toxicity. Participants were evaluated for toxicity every two weeks.|Of the 16 patients enrolled in the phase I study, five were not evaluable for MTD determination due to intercurrent illnesses interfering with toxicity assessment or withdrawal and were replaced or excluded.|||mg/day|||Number
1247834|NCT00526591|Primary|Proportion of Patients Who Are P0 (i.e., no Clinically Detectable Tumor in the Pathologic Specimen) at Surgery|Specimens are fixed in formalin for 24 hours.Specimens are the cut at 3 mm intervals perpendicular to the rectal surface and the sections are examined grossly and microscopically on routine Hematoxylin and Eosin stain (H&E) (pathologic complete response or P0) will be defined as responders.|After 8 weeks of therapy at the time of prostatectomy|Intention to treat|||participants|||Number
1247797|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points|Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (<LLN to 3000/mm^3 of blood plasma [bp]), mild; G 2 (<3000 to 2000/mm^3 of bp), moderate; G 3 (<2000 to 1000/mm^3 of bp), severe; G 4 (<1000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247798|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points|Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (<LLN to 75000/mm^3 of blood plasma [bp]), mild; G 2 (<75000 to 50000/mm^3 of bp), moderate; G 3 (<50000 to 25000/mm^3 of bp), severe; G 4 (<25000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247799|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points|Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (<LLN to 1500/millimeters cubed [mm^3] of blood plasma [bp]), mild; G 2 (<1500 to 1000/mm^3 of bp), moderate; G 3 (<1000 to 500/mm^3 of bp), severe; G 4 (<500/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247800|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points|Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247801|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points|Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (<LLN to 10 g/dL), mild; G 2 (<10.0 to 8.0 g/dL), moderate; G 3 (<8.0 to 6.5 g/dL), severe; G 4 (<6.5 g/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247802|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points|Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (>ULN to 150 mmol/L; <LLN to 130 mmol/L), mild; G 2 (>150 to 155 mmol/L; value not available), moderate; G 3 (>155 to 160 mmol/L; <130 to 120 mmol/L), severe; G 4 (>160 mmol/L; <120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247803|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points|Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (>ULN to 3.0 mg/dL; <LLN to 1.2 mg/dL), mild; G 2 (value not available; <1.2 to 0.9 mg/dL), moderate; G 3 (>3.0 to 8.0 mg/dL; <0.9 to 0.7 mg/dL), severe; G 4 (>8.0 mg/dL; <0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1248042|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 64 weeks||||liters||Standard Error|Least Squares Mean
1247804|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points|Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low [per blood samples], respectively): G 1 (>ULN to 5.5 millimoles per liter [mmol/L]; <LLN to 3.0 mmol/L), mild; G 2 (>5.5 to 6.0 mmol/L; value not available), moderate; G 3 (>6.0 to 7.0 mmol/L; <3.0 to 2.5 mmol/L), severe; G 4 (>7.0 mmol/L; <2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247805|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points|Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (>ULN to 160 mg/dL; <LLN to 55 mg/dL), mild; G 2 (>160 to 250 mg/dL; <55 to 40 mg/dL), moderate; G 3 (>250 to 500 mg/dL; <40 to 30 mg/dL), severe; G 4 (>500 mg/dL; <30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247806|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points|Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 6.0x ULN), severe; G 4 (>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247807|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points|Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (<LLN to 8.0 mg/dL; >ULN to 11.5x ULN), mild; G 2 (<8.0 to 7.0 mg/dL; >11.5 to 12.5 ULN), moderate; G 3 (<7.0 to 6.0 mg/dL; >12.5 to 13.5 mg/dL), severe; G 4 (<6 mg/dL; >13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247808|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points|Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 10.0x ULN), severe; G 4 (>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247809|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points|Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247810|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points|Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247953|NCT00526097|Secondary|Number of Premature Withdrawals at Week 3 in the Treatment Period||Week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247811|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points|Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal [ULN] to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247812|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points|Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (<lower limit of normal [LLN] to 3 grams per deciliter [g/dL]), mild; G 2 (<3 to 2 g/dL), moderate; G 3 (<2 g/dL), severe; G 4 (value not available), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
1247813|NCT00526669|Secondary|Number of Participants in the Indicated Categories for Best Overall Response (BOR)|Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population|||participants|||Number
1247814|NCT00526669|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first.|From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks)|ITT Population. Duration of response was estimated for only the subset of participants who had response. Duration of response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||95% Confidence Interval|Median
1247815|NCT00526669|Secondary|Time to Response|Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point.|Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)|ITT Population. Time to response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||Inter-Quartile Range|Median
1247816|NCT00526669|Secondary|Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)|Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||Inter-Quartile Range|Median
1247817|NCT00526669|Secondary|Time to Progression (All Deaths Are Treated as Competing Risk)|Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||Inter-Quartile Range|Median
1247818|NCT00526669|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication.|From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)|ITT Population. OS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||95% Confidence Interval|Median
1247876|NCT00526162|Secondary|Describe System Performance|System performance was assessed by reviewing Holter records, Save to disk files and technical observations. Only descriptive statistics were presented,no comparative measure was analyzed. 20 24-hour Holter records and 94 Save to Disk Files were reviewed. 3 minor anomalies were found, and were deemed acceptable. There was no patient safety risk.|1 month|The device performed as intended.|||participants|||Number
1247819|NCT00526669|Secondary|PFS|PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact).|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||95% Confidence Interval|Median
1247820|NCT00526669|Primary|Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)|5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of >=1 NL and/or unequivocal progression of existing non-TLs, and a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.|From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)|ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||percentage of participants|||Number
1247821|NCT00526669|Primary|Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])|Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as >= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.|From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)|ITT Population|||percentage of participants|||Number
1247822|NCT00526669|Primary|Change From Start of Run-in Period in Biomarker Expression Levels at Day 0|Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.|evaluated at baseline and after 7 days of study treatment|Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants contributing viable samples were analyzed. Different participants contributed samples for different biomarkers.|||ratio||Full Range|Median
1247823|NCT00526630|Secondary|The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.|The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem; see appendix). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The range is from 0 to 100, with 100 indicating the best health status.|Week 12 and 27||||units on a scale||Standard Deviation|Mean
1247824|NCT00526630|Secondary|The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0–9 range is considered to be normal while a number in the 10–24 range indicates excessive daytime sleepiness. Higher scores imply worse sleepiness.|Week 12 and 27||||units on a scale||Standard Deviation|Mean
1247825|NCT00526630|Secondary|Montgomery–Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.|MADRS is a questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60|Week 12 and 27||||units on a scale||Standard Deviation|Mean
1247826|NCT00526630|Secondary|Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.|FOGQ is a questionnaire that quantifies severity of gait and falls. It contains 16 items with a 0-4 severity scale for each, for a range of 0 (normal) to 64 (most severe impairment).|Week 12 and 27||||units on a scale||Standard Deviation|Mean
1247827|NCT00526630|Secondary|Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.|Freezing and shuffling are measures of ambulatory impairment.|Week 12 and 27||||hours||Standard Deviation|Mean
1247828|NCT00526630|Primary|The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.|"Gait velocity is a measure of distance over time in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors."|Week 12 and 27||||centimeters/second||Standard Deviation|Mean
1247829|NCT00526630|Primary|The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.|"Gait stride length is the distance between two consecutive steps in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors."|Week 12 and 27||||centimeters||Standard Deviation|Mean
1247830|NCT00526630|Secondary|The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks|Patients will have a mild to severe gait disturbance with score >1 on the motor subscale of the Unified Parkinson’s disease rating scale (UPDRS) but without need for a continuous ambulatory aid such as walker or wheelchair (Hoehn & Yahr 2-3). The highest score possible for the UPDRS is 108 which indicates severe motor impairment. The lowest score for the UPDRS is 0 which indicates no motor impairment.|At week 12 and 27||||units on a scale||Standard Deviation|Mean
1247835|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247836|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of a UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247837|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247838|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247839|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247840|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247841|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization|The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247842|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1248127|NCT00524745|Secondary|Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months||||GMT ratio||95% Confidence Interval|Number
1247843|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization|The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247844|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR, or UH-VCIN . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247845|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization|The time (in days) from study start to the occurrence of CV death or first occurrence of an MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Partcipants|||Number
1247846|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247847|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the TIMI Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.|up to 3 years|Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug|||Percentage of Participants|||Number
1247848|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Met GUSTO Moderate or Severe Bleeding Criteria Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.|up to 3 years|Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug|||Percentage of Participants|||Number
1247849|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
1247877|NCT00526162|Primary|Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant.|Only subjects implanted with a Consulta device that were followed at least 28 days post-implant, or have had a unanticipated device effect within 28 days after implant were included in the analysis.|1 month||||percentage of participants|||Number
1247850|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with coronary arterial disease (CAD) or peripheral arterial disease (PAD) and no history of a stroke or transient ischemic attack (TIA)|||Percentage of Participants|||Number
1247851|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of a revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247852|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247853|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247854|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247855|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247856|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247857|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization|The time (in days) from study start to CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1248043|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 48 weeks||||liters||Standard Error|Least Squares Mean
1247858|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247859|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization|The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247860|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or Urgent Hospitalization for Vascular Cause of Ischemic Nature (UH-VCIN) Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247861|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization|The time (in days) from study start to the occurrence of CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247862|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Perentage of Participants|||Number
1247863|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.|up to 3 years|As Treated Population, which included all participants who received at least 1 dose of study medication.|||Percentage of Participants|||Number
1247864|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.|up to 3 years|As Treated Population, which included all participants who received at least 1 dose of study medication.|||Percentage of Participants|||Number
1248044|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 32 weeks||||liters||Standard Error|Least Squares Mean
1247865|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247866|NCT00526474|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intent to Treat (ITT) Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
1247867|NCT00526331|Primary|Length of Hospital Stay (LOS) by Participant|Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.|From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)|Study terminated by sponsor without analysis due to technical reasons.|||days|||Number
1247868|NCT00526292|Primary|Treatment Efficacy as Defined by Complete or Partial Remission||3 Months following treatment||||participants|||Number
1247869|NCT00526227|Secondary|Adverse Events|A total of 62 Adverse Events were reported in 43 subjects.|1 Month||||participants|||Number
1247870|NCT00526227|Secondary|Describe System Performance|System performance was assessed by reviewing Holter records, Save to disk files and technical observation. Only descriptive statistics were presented, no comparative measure was analyzed. 21 24-hour digital Holter records were review. 140 Save to Disk Files was reviewed. No anomalies were found. The device performed as intended.|1 month||||participants|||Number
1247871|NCT00526227|Primary|Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant.|Only subjects implanted with a Secura device that were followed at least 28 days post-implant, or have had a unanticipated device effect within 28 days after implant were included in the analysis.|1 month|Seventy-nine subjects completed at least one-month (28 days)of follow-up post-implant and were included in the analysis. One subject died prior to the 1-month follow-up.|||Percentage of participants|||Number
1247872|NCT00526188|Secondary|Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points|Three Blinded Reader performed lesion characterization in pre- and combined pre-/post-contrast MRI image set. Per Blinded Reader/image set combination, precision of lesion characterization was calculated: (number of unique Standard of Reference-matched characterizations detected for the Reader/image set combination)/(number of unique lesion characterizations in Standard of Reference)*100%. Then, difference in precision of lesion characterization for post- minus combined pre-/post-contrast MRI (in percentage points) was calculated for each Blinded Reader.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set with pre- and combined pre- and post- contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion characterization in the Standard of reference (SOR)|||Percentage points||95% Confidence Interval|Mean
1247873|NCT00526188|Secondary|Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points|The on-site investigators performed lesion detection in pre- and post-contrast MRI image sets. Per image set, sensitivity of lesion detection was calculated, as: (number of lesions detected in image set)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI (in percentage points) was calculated.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set, with at least 1 lesion in the Standard of Reference (SOR).|||Percentage points||95% Confidence Interval|Mean
1247874|NCT00526188|Primary|Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points|Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set with pre- and post-contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion in the Standard of Reference (SOR)|||Percentage points||95% Confidence Interval|Mean
1247875|NCT00526162|Secondary|Adverse Events|A total of 70 Adverse Events were reported in 44 subjects.|1 month||||participants|||Number
1247950|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 1 in the Treatment Period||Week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247878|NCT00526123|Secondary|Reliability of the Catheter|Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.|35 Weeks|Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had the study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of study visits||Standard Deviation|Mean
1247879|NCT00526123|Secondary|Primary Failure Rate|The percentage of catheters unable to deliver adequate blood flow of at least 300 mL/min for at least 50% of measurements during the first attempted dialysis session.|First dialysis session with study catheter|Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had a study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of catheters|||Number
1247880|NCT00526123|Secondary|Frequency of Clinician Interventions for Catheter Malfunction and Infection|Average number of times clinician intervention was required for either catheter malfunction or infection|35 Weeks|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||events||Standard Deviation|Mean
1247881|NCT00526123|Secondary|Average Number of Line Reversals Per Subject|Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments|35 Weeks|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||events||Standard Deviation|Mean
1247882|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|245 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of participants|||Number
1247883|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|60 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of participants|||Number
1247884|NCT00526123|Secondary|Inadequate Flow Rates Requiring Surgical/Radiological Intervention|Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.|35 weeks|Number of participants is derived from the 'intent to treat' population defined as those subjects that were randomized.|||events|||Number
1247885|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|30 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of participants|||Number
1247886|NCT00526110|Secondary|Median Overall Survival|Overall survival was defined as the time from the start of treatment until death or last follow-up. Kaplan-Meier curve was used to estimate overall survival.|Up to 30 months||||months||Full Range|Median
1247887|NCT00526110|Primary|Progression Free Survival|Progression Free Survival (PFS) defined as the time from the first study drug administration until the first day of radiological and/or symptomatic disease progression is documented, or the start of further anticancer therapy or death from any cause, whichever occurs first. Kaplan-Meier curve was used to estimate PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.|Assessed from baseline to 30 months||||months||95% Confidence Interval|Median
1247888|NCT00526110|Primary|Maximum Tolerated Dose (MTD)|MTD is the highest dose at which 1 or fewer dose limiting toxicities (DLT’s) are observed in 6 patients. DLT defined as any non-hematologic grade III/IV or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy. Response evaluated after two 14-day treatments of Docetaxel, 5-Fluorouracil and Oxaliplatin (One cycle = 28 days).|28 days||||mg/m^2|||Number
1247889|NCT00526097|Secondary|Change From Baseline for Chloride (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||mmol/L||Standard Deviation|Mean
1247890|NCT00526097|Secondary|Change From Baseline for Potassium (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||mmol/L||Standard Deviation|Mean
1247891|NCT00526097|Secondary|Change From Baseline for Sodium (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||mmol/L||Standard Deviation|Mean
1247892|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Overall Score|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247951|NCT00526097|Secondary|Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247893|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Satisfaction'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247894|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247895|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247896|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247897|NCT00526097|Secondary|Change From Baseline in the SF-36 Physical Component Scale (PCS)|The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247898|NCT00526097|Secondary|Change From Baseline in the SF-36 Mental Component Scale (MCS)|The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247899|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Mental Health'|The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247900|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'|The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247901|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Social Functioning'|The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247902|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Vitality'|The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247903|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'General Health'|The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247904|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Bodily Pain'|The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247998|NCT00525824|Secondary|Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment|Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247905|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'|The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247906|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Physical Functioning'|The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247907|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||Participants|||Number
1247908|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||Participants|||Number
1247909|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247910|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247911|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247912|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247913|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247914|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247915|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247916|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247999|NCT00525824|Secondary|Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment|Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247917|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247918|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247919|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247920|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247921|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247922|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247923|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247924|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247925|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247926|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247952|NCT00526097|Secondary|Number of Premature Withdrawals at Week 4 in the Treatment Period||Week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247927|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247928|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247929|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247930|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247931|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247932|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247933|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247934|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247935|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247936|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247937|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247938|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247939|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247940|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247941|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247942|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247943|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247944|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247945|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247946|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
1247947|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 4 in the Treatment Period||Week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247948|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 3 in the Treatment Period||Week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247949|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 2 in the Treatment Period||Week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1248128|NCT00524745|Primary|Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months||||GMT ratio||95% Confidence Interval|Number
1247954|NCT00526097|Secondary|Number of Premature Withdrawals at Week 2 in the Treatment Period||Week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247955|NCT00526097|Secondary|Number of Premature Withdrawals at Week 1 in the Treatment Period||Week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247956|NCT00526097|Secondary|Number of Premature Withdrawals Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247957|NCT00526097|Secondary|Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247958|NCT00526097|Secondary|Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247959|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline||Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247960|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline||Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247961|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline||Baseline and week 2 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247962|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline||Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247963|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline||Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
1247964|NCT00526097|Secondary|Time to the First SBM Following the First Dose of Study Medication (SM)|The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.|Time of first dose of SM up to 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Hours||95% Confidence Interval|Median
1247965|NCT00526097|Secondary|Number of SBMs at Week 4|The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
1247966|NCT00526097|Secondary|Number of SBMs at Week 3|The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
1247967|NCT00526097|Secondary|Number of SBMs at Week 2|The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
1247968|NCT00526097|Secondary|Number of SBMs at Week 1|The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
1247969|NCT00526097|Secondary|Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period|A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.|4 Weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
1247970|NCT00526097|Secondary|Number of CSBMs at Week 4|The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
1247971|NCT00526097|Secondary|Number of CSBMs at Week 3|The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
1247972|NCT00526097|Secondary|Number of CSBMs at Week 2|The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
1247973|NCT00526097|Secondary|Number of CSBMs at Week 1|The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 1 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
1247974|NCT00526097|Primary|Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period|"A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool.~The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data."|4 Weeks|Full Analysis Set (FAS): All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
1247975|NCT00526071|Secondary|Pharmacokinetics Of Migalastat As Assessed By Plasma Concentration|The concentration of migalastat was evaluated in plasma following a dose of 250 mg and 500 mg. Blood samples were taken at trough (predose or Time 0; just prior to the third dose during a 3 day on, 4 days off dosing regimen) and at peak (3 hr postdose; after the third dose during a 3 day on, 4 days off dosing regimen) during the Day 1 (250 mg) and Month 2 (500 mg) visits. This outcome presents the lowest and highest concentrations of migalastat measured in any of the participants for predose and 3 hr postdose.|0 (predose on Day 1; start of DEP), 3 hr (postdose at Month 2; during DEP])|Safety Population: all participants who received at least 1 dose of study drug.|||nanograms/milliliter|||Number
1247976|NCT00526071|Secondary|Absolute Change From Baseline In α-Galactosidase A (α-Gal A) Activity In Leukocytes To Month 42|The activity of the α-Gal A enzyme was measured in leukocyte lysate by a validated fluorometric assay method, using 4-methylumbelliferone as a reference. The activity values obtained were normalized to protein (measured using a colorimetric assay). Baseline was defined as the last non-missing pre-treatment value for each participant in his or her respective preceding migalastat Phase 2 study. A negative change from Baseline indicates that α-Gal A activity decreased. α-Gal A activity levels are presented for Baseline and Month 42.|Baseline, Month 42|PD Population: all participants who received at least 1 dose of study drug and who had a baseline measurement and at least 1 postbaseline PD measure.|||nanomoles (nm)/hour (hr)/mg protein||Standard Deviation|Mean
1247977|NCT00526071|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through End of Study (EOS) or follow-up (for participants who did not enroll in Study AT1001-041) are presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through EOS (up to 56 months) or follow-up (28 days after EOS)|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1247978|NCT00526058|Secondary|Device Parameters|Comparison of plasma flow rate recorded with both systems before treatment, after 500 mL of plasma treated, and at the end of each treatment session.|Analyzed at specific time points throughout the study from week 0 to week 24.|Data for all 18 subjects; regardless of treatment sequence|||flow rate (mL/min)||Standard Deviation|Mean
1247979|NCT00526058|Secondary|Clinical Lab Profiles (Pre- and Post-Treatment)|Changes in pre- and post-treatment levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), total triglycerides, lipoprotein (a), fibrinogen, and C-reactive protein.|Analyzed at specific time points throughout the study from week 0 to week 24.|Data for all 18 subjects; regardless of treatment sequence|||percent change||90% Confidence Interval|Mean
1247980|NCT00526058|Primary|Percent Change of the Pre and Post Treatment Value|The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.|Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.||||percent change||Standard Deviation|Mean
1247981|NCT00526058|Primary|Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.||Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..||||percent change||90% Confidence Interval|Mean
1248000|NCT00525824|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment|Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247982|NCT00525915|Primary|Pathologic Complete Response Rate|Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) <50% of residual cells in the surgical specimen; or 3) >50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.|Surgery post chemotherapy (approximately 10-11 weeks)|Participants who had surgery were reported for the pathCR rate assessment in this outcome.|||percentage of participants|||Number
1247983|NCT00525902|Primary|Cumulative Endpoint|Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.|50 Weeks|Participants characterized as clinical responders at 10 weeks were allowed to continue in the study.|||participants|||Number
1247984|NCT00525902|Primary|Cumulative Endpoint|Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.|10 weeks||||participants|||Number
1247985|NCT00525876|Primary|Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)|Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.|100 days post transplant|Analysis was per protocol.|||participants|||Number
1247986|NCT00525837|Secondary|Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)|"Reference:~Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare~The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients)."|6-8 weeks||||units on a scale||Standard Deviation|Mean
1247987|NCT00525837|Secondary|Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)|Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al, 1995). The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a “normal” score, while an “abnormal” score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the “disagree” responses score one point, and either of the “agree” responses score 0 points. Thus, the final score ranges from 0 to 14. The SHAPS has adequate construct validity and satisfactory test-retest reliability (ICC=0.70) (Franken et al, 2007). High internal consistency has also been reported (Cronbach’s alpha of 0.94) (Franken et al, 2007)|6-8 weeks||||score on a scale||Standard Error|Mean
1247988|NCT00525837|Primary|Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report|"this is a 16-item self report questionnaire that measures depressive symptoms.~Improvement is reported in change in depressive score~score ranges from 0-27, with higher numbers indicating more severe symptom reporting.~change is calculated by baseline plus/minus the value at the later time point"|Baseline and every 2 weeks until 8 weeks or study endpoint||||Units on a scale||95% Confidence Interval|Mean
1247989|NCT00525824|Secondary|Percent Change in LDL-C After 6 Weeks Monotherapy|Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247990|NCT00525824|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment|Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Full Range|Mean
1247991|NCT00525824|Secondary|Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment|Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247992|NCT00525824|Secondary|Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment|Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247993|NCT00525824|Secondary|Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment|Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247994|NCT00525824|Secondary|Percent Change in TC/HDL-C After 6 Weeks Combination Treatment|Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247995|NCT00525824|Secondary|Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment|Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247996|NCT00525824|Secondary|Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment|Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1247997|NCT00525824|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment|Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1248001|NCT00525824|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment|Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
1248002|NCT00525798|Secondary|Number of Patients With Non-vertebral Fractures|"The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures.~Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist’s report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained."|From baseline to month 36|all randomized patients|||Participants|||Number
1248003|NCT00525798|Primary|Number of Patients With New Vertebral Fractures|"The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter).~The outcome is the number of new vertebral fractures from baseline to 36 months."|From baseline to month 36|all patients randomized who received at least one dose of study drug, with the addition of evaluable baseline spine X-ray and at least one follow-up for calculation of vertebral fractures.|||Participants|||Number
1248004|NCT00525733|Primary|The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.||48 weeks||||# subjects without detectable viremia|||Number
1248005|NCT00525629|Primary|Insulin Resistance|HOMA-IR (homeostatic model assessment of insulin resistance) given in units as it is a ratio equation.|4 days||||HOMA-IR index||Standard Deviation|Mean
1248006|NCT00525603|Primary|Overall Participant Response|Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.|Evaluated after 3 courses of 4 week therapy (12 weeks)|Sixty participants were analyzed for response. Four participants did not have a response and one participant was not evaluable.|||Participants|||Number
1248007|NCT00525525|Primary|Unexpected Toxicities During First 2 Cycles of Study Drug|Unexpected severe study-related adverse events|Within 8 weeks of initiating study therapy||||Events|||Number
1248008|NCT00525525|Secondary|Progression-free Survival|Progression-free survival was defined from the date of diagnosis to the date that progressive disease was first observed on imaging, or the date at which nonreversible neurologic progression or permanently increased corticosteroid requirement, death from any cause, or early discontinuation of treatment. Imaging guidelines were used to evaluate progression: (i) 25% increase in the sum of products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline; (ii) clear worsening of any assessable disease; (iii) appearance of any new lesion/site; and (iv) clear clinical worsening or failure to return for evaluation as a result of death or deteriorating condition (unless clearly unrelated to this cancer).|Approximately 6 months to 1 year||||months||95% Confidence Interval|Median
1248009|NCT00525525|Primary|Overall Survival (OS)|Overall survival was defined from the date of diagnosis to date of death from any cause|Approximately 6-24 months||||months||95% Confidence Interval|Median
1248010|NCT00525512|Secondary|Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status|Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|From first drug administration until 30 days after last drug administration||||participants|||Number
1248011|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks||||units on scale||Standard Error|Least Squares Mean
1248012|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks||||units on scale||Standard Error|Least Squares Mean
1248013|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks||||units on scale||Standard Error|Least Squares Mean
1248014|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks||||units on scale||Standard Error|Least Squares Mean
1248015|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 100 weeks||||liters||Standard Error|Least Squares Mean
1248016|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 100 weeks||||liters||Standard Error|Least Squares Mean
1248017|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 100 weeks||||seconds||95% Confidence Interval|Least Squares Mean
1248019|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
1248020|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
1248021|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
1248022|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
1248023|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 96 weeks||||units on scale||Standard Error|Mean
1248024|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 80 weeks||||units on scale||Standard Error|Mean
1248025|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 64 weeks||||units on scale||Standard Error|Mean
1248026|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 48 weeks||||units on scale||Standard Error|Mean
1248027|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 32 weeks||||units on scale||Standard Error|Mean
1248028|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 16 weeks||||units on scale||Standard Error|Mean
1248029|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 8 weeks||||units on scale||Standard Error|Mean
1248030|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 96 weeks||||units on scale||Standard Error|Mean
1248031|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 80 weeks||||units on scale||Standard Error|Mean
1248032|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 64 weeks||||units on scale||Standard Error|Mean
1248033|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 48 weeks||||units on scale||Standard Error|Mean
1248034|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 32 weeks||||units on scale||Standard Error|Mean
1248035|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 16 weeks||||units on scale||Standard Error|Mean
1248036|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 8 weeks||||unit on scale||Standard Error|Mean
1248037|NCT00525512|Secondary|Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks||||unit on scale||Standard Error|Least Squares Mean
1248038|NCT00525512|Secondary|Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks||||unit on scale||Standard Error|Least Squares Mean
1248039|NCT00525512|Secondary|Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
1248040|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 96 weeks||||liters||Standard Error|Least Squares Mean
1248041|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 80 weeks||||liters||Standard Error|Least Squares Mean
1248051|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 32 weeks||||liters||Standard Error|Least Squares Mean
1248052|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 16 weeks||||liters||Standard Error|Least Squares Mean
1248053|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 8 weeks||||liters||Standard Error|Least Squares Mean
1248054|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 96 weeks||||liters||Standard Error|Least Squares Mean
1248055|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 80 weeks||||liters||Standard Error|Least Squares Mean
1248056|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 64 weeks||||liters||Standard Error|Least Squares Mean
1248057|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 48 weeks||||liters||Standard Error|Least Squares Mean
1248058|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 32 weeks||||liters||Standard Error|Least Squares Mean
1248059|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 16 weeks||||liters||Standard Error|Least Squares Mean
1248060|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 8 weeks||||liters||Standard Error|Least Squares Mean
1248061|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 96 weeks||||liters||Standard Error|Least Squares Mean
1248062|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 80 weeks||||liters||Standard Error|Least Squares Mean
1248063|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 64 weeks||||liters||Standard Error|Least Squares Mean
1248064|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 48 weeks||||liters||Standard Error|Least Squares Mean
1248065|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 32 weeks||||liters||Standard Error|Least Squares Mean
1248066|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 16 weeks||||liters||Standard Error|Least Squares Mean
1248067|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 8 weeks||||liters||Standard Error|Least Squares Mean
1248068|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 80 weeks||||seconds||95% Confidence Interval|Least Squares Mean
1248069|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 64 weeks||||seconds||95% Confidence Interval|Least Squares Mean
1248070|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 48 weeks||||seconds||95% Confidence Interval|Least Squares Mean
1248071|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 32 weeks||||seconds||95% Confidence Interval|Least Squares Mean
1248072|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 16 weeks||||seconds||95% Confidence Interval|Least Squares Mean
1248073|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 8 weeks||||seconds||95% Confidence Interval|Least Squares Mean
1248074|NCT00525512|Primary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 96 weeks|Full Analysis Set (FAS) includes all treated participants with a baseline and any post-dosing exercise duration data|||seconds||95% Confidence Interval|Least Squares Mean
1248075|NCT00525499|Secondary|Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12|"The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne:~0 No acne lesions.~Rare non-inflammatory lesions.~Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.~Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.~Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.~Highly inflammatory lesions, multiple nodulo-cystic lesions."|Baseline to Week 12|ITT population: All randomized subjects|||Participants|||Number
1248076|NCT00525499|Primary|Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12|Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.|Baseline to Week 12|ITT population: All randomized subjects|||Percent change||Standard Deviation|Mean
1248077|NCT00525421|Secondary|Change in Serum C-reactive Protein and Serum Interleukin-6 Levels|Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).|2 weeks||||Percent change||Inter-Quartile Range|Median
1248078|NCT00525421|Primary|Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)|Numeric Rating Scale (NRS) is patient-reported numerical score for intensity of symptoms (range 0-10, where 0=no oral discomfort and 10=worst imaginable oral discomfort; symptom score over the last 1 week was recorded at baseline, and symptom score since baseline was recorded at follow-up. For Modified Oral Mucositis Index (MOMI) each of 16 oral sites is scored by an examiner for both erythema intensity (range 0-3 where 0=normal, 1=mild, 2=moderate, 3=severe) and area of ulceration (range 0-3 where 0=none, 1=>0-0.25 cm^2, 2= >0.25-1 cm^2, 3=>=1cm^2): right (R) and left (L) buccal mucosa, labial mucosa (upper and lower), lateral tongue (R and L), dorsum of tongue (R and L), ventral tongue and floor of mouth (R and L), maxillary gingiva (R and L), mandibular gingiva (R and L), and soft and hard palate. Total score for clinical signs (MOMI) is the sum of scores for 16 sites; separate scores for erythema and ulceration are the sums of respective scores.|2 weeks||||percent change||Inter-Quartile Range|Median
1248079|NCT00525265|Primary|Body Weight|The body weight change from baseline at the time of final trial drug administration|Baseline, at the time of final trial drug administration||||Kg||Standard Deviation|Mean
1248080|NCT00525174|Secondary|Social Stigma From Treatment at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.|24 weeks||||Units on a scale||Standard Deviation|Mean
1248081|NCT00525174|Secondary|Social Stigma From Treatment at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.|6 weeks||||Units on a scale||Standard Deviation|Mean
1248082|NCT00525174|Secondary|Compliance With Treatment at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.|24 weeks||||Units on a scale||Standard Deviation|Mean
1248083|NCT00525174|Secondary|Compliance With Treatment at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.|6 weeks||||Units on a scale||Standard Deviation|Mean
1248084|NCT00525174|Secondary|Adverse Effects of Treatment on Patient and Family at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.|24 weeks||||Units on a scale||Standard Deviation|Mean
1248085|NCT00525174|Secondary|Adverse Effects of Treatment on Patient and Family at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.|6 weeks||||Units on a scale||Standard Deviation|Mean
1248086|NCT00525174|Secondary|Impact of Treatment on Patient and Family at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.|24 weeks||||Units on a scale||Standard Deviation|Mean
1248129|NCT00524745|Primary|Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months||||GMT ratio||95% Confidence Interval|Number
1248130|NCT00524680|Secondary|Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls|Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls|Baseline, at 1, 3 ,6 months|All treated and eligible patients|||participants|||Number
1248087|NCT00525174|Secondary|Impact of Treatment on Patient and Family at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.|6 weeks||||Units on a scale||Standard Deviation|Mean
1248088|NCT00525174|Secondary|Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||logMAR line||Standard Deviation|Mean
1248089|NCT00525174|Secondary|Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||participants|||Number
1248090|NCT00525174|Secondary|Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).|Baseline to 24 weeks||||participants|||Number
1248091|NCT00525174|Secondary|Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).|Baseline to 24 weeks||||participants|||Number
1248092|NCT00525174|Secondary|Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||logMAR line||Standard Deviation|Mean
1248093|NCT00525174|Secondary|Distribution of Patient Characteristics at the 24-week Outcome Exam.|The distribution of the number of participants in each patient characteristic category at the 24-week outcome examination was found (for example, the number of participants at 24 weeks who were 3 to <5 years old at the time of enrollment).|24 weeks||||participants|||Number
1248094|NCT00525174|Secondary|Distribution of Subjects With 3 or More Lines of Improvement|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||participants|||Number
1248095|NCT00525174|Secondary|Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks||||participants|||Number
1248096|NCT00525174|Secondary|Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).|24 weeks||||participants|||Number
1248131|NCT00524680|Secondary|Toxicity|Number of treated patients that had serious adverse events.|Baseline, at 1, 3 and 6 months|All treated and eligible patients|||participants|||Number
1248173|NCT00524459|Primary|Pathological Complete Response||Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1248097|NCT00525174|Secondary|Mean Interocular Difference at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).|24 weeks||||logMAR line||Standard Deviation|Mean
1248098|NCT00525174|Primary|Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||logMAR line||Standard Deviation|Mean
1248099|NCT00525174|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). 'Worse' indicates acuity at 24 weeks is worse than acuity at baseline; 'Better' indicates acuity at 24 weeks is better than acuity at baseline.|Baseline to 24 weeks||||participants|||Number
1248100|NCT00525174|Primary|Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks||||logMAR||Standard Deviation|Mean
1248101|NCT00525174|Primary|Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks||||participants|||Number
1248102|NCT00525161|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.|24 weeks||||percentage of participants||95% Confidence Interval|Number
1248103|NCT00525161|Secondary|Time to Progression||continuously||||months||95% Confidence Interval|Median
1248104|NCT00525161|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.|12 weeks after treatment & 8 weeks after initial documentation of response|one discontinued treatment after 2 weeks owing to a grade 3 rash and was not evaluable for response|||participants|||Number
1248105|NCT00525148|Secondary|Safety of BIBW 2992 as Indicated by Intensity and Incidence of Worst Adverse Events Graded According to NCI CTCAE Version 3.0|Safety of afatinib as indicated by intensity and incidence of worst adverse events graded according to National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) Version 3.0 (R04-0474).|First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.|Treated set|||Percentage of participants|||Number
1248106|NCT00525148|Secondary|Safety of BIBW 2992 as Indicated by Incidence of Specified Adverse Events.|Safety of afatinib as indicated by incidence of specified adverse events: skin reactions (a preferred term of the system organ class: Skin and subcutaneous tissue disorders) and gastrointestinal (GI) (a system organ class).|First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.|Treated set|||Percentage of participants|||Number
1248107|NCT00525148|Secondary|Cpre,ss,29|Predose concentration of the analyte in plasma at steady state immediately before administration of the 29th dose (Cpre,ss,29).|-0:05h (pre-dose) on Day 29|Treated Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1248108|NCT00525148|Secondary|Overall Survival Time|Overall survival time (OS) was also evaluated and was defined as the duration of time from start of treatment to time of death up to 93 months, regardless of the cause of death. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood’s standard error estimate.|Start of treatment to time to all death, up to 93 months|Treated set|||Months||95% Confidence Interval|Median
1248109|NCT00525148|Secondary|Progression-free Survival|Progression-free survival (PFS) as per independent review was defined as the duration of time from the start of treatment until the day of objective tumor progression was confirmed by tumor imaging (Progressive Disease according to RECIST 1.0) or death, whichever came first. Patients with unknown progression status or unknown date of progression were reviewed on a case-by-case basis. Patients known to be alive without progression at the end of the trial or the last follow-up visit were censored at the date of the last imaging when the patient was known to be alive and progression-free. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood’s standard error estimate.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated Set|||Months||95% Confidence Interval|Median
1248110|NCT00525148|Secondary|Time to Objective Response|"Time to objective response was defined as the number of days from the start of treatment to the first recorded objective response. Patients who did not experience objective response during the study were censored at the time of treatment discontinuation.~The results are provided as the percentage of participants for this Outcome Measure."|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set|||Percentage of participants|||Number
1248111|NCT00525148|Secondary|Duration of Objective Response|Duration of objective response (OR) was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death (or date of censoring for PFS) was objectively documented as per independent review.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set including only patients with objective response.|||Weeks||Standard Deviation|Mean
1248112|NCT00525148|Secondary|Duration of Clinical Benefit|Duration of clinical benefit (disease control) as per independent review was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence of SD, PR or CR.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated Set|||weeks||Standard Deviation|Mean
1248113|NCT00525148|Secondary|Clinical Benefit as Determined by RECIST 1.0|Clinical benefit was evaluated according to RECIST 1.0 by independent review assessment. Patients whose best RECIST 1.0 assessment was stable disease (SD), partial response (PR), or complete response (CR) were considered to have derived a clinical benefit from treatment.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set|||Percentage of participants||95% Confidence Interval|Number
1248114|NCT00525148|Primary|Objective Response (OR) as Determined by RECIST 1.0|Objective response (OR) was assessed for all treated patients by independent review as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. OR included complete response (CR) and partial response (PR), where CR or PR must have been confirmed by a subsequent response in ≥28 days.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set: The patients who had taken at least one dose of afatinib were included in the treated set.|||percentage of participants||95% Confidence Interval|Number
1248115|NCT00525135|Secondary|Survival||up to 10 years post-study treatment|Due to early termination, participants were not followed for survival after the primary outcome timeframe||||||
1248116|NCT00525135|Primary|Decrease in Tumor Size|Number of participants with decreased tumor size after study treatment|Baseline, 16 weeks||||participants|||Number
1248117|NCT00525135|Secondary|Side Effects of Drugs Affecting Quality of Life|Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment|17 weeks||||participants|||Number
1248118|NCT00525135|Secondary|Increased Radioactive Iodine Uptake|Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy|Baseline, 10 weeks||||participants|||Number
1248119|NCT00525135|Primary|Decrease in Thyroglobulin Level|Number of participants with decreased thyroglobulin level after study treatment|Baseline, 16 weeks||||participants|||Number
1248120|NCT00525031|Primary|Response to Neoadjuvant Therapy: Overall Clinical Responses|Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or > decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): > 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.|Evaluated after a total of 8 weeks of therapy before definitive surgery.||||Participants|||Count of Participants
1248121|NCT00525031|Primary|Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD)|Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD). Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or > decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): > 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.|Evaluated after a total of 8 weeks of therapy before definitive surgery.||||Participants|||Count of Participants
1248122|NCT00524940|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.|GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.|21 days post-vaccination|The GMT were evaluated in the per-protocol Population|||Titer||95% Confidence Interval|Geometric Mean
1248123|NCT00524940|Primary|Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.|Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.|0-3 days post-vaccination and entire study duration|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population.|||Participants|||Number
1248124|NCT00524771|Primary|Number of Participants With Arterial Thromboembolism (ATE)|Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.|Time to event analysis within 48 months||||participants|||Number
1248125|NCT00524771|Primary|Number of Participants With Venous Thromboembolism (VTE)|Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.|Time to event analysis within 48 months|Study participants that were not excluded due to protocol violations.|||participants|||Number
1248132|NCT00524680|Secondary|Pattern of Response of Parathormone|Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.|Baseline, at 1, 3, 6 months|All treated and eligible patients|||pg/mL||Standard Deviation|Mean
1248133|NCT00524680|Primary|Pattern of Response of Serum 25(OH) D3 Levels|Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.|Baseline, at 1, 3, 6 months|All treated and eligible patients|||ng/mL||Standard Deviation|Mean
1248134|NCT00524589|Secondary|Corrected Serum Calcium Expression|Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.|1 year|All treated and eligible patients|||Participants|||Count of Participants
1248135|NCT00524589|Primary|Objective Response (Complete or Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|All treated and eligible patients|||percentage of participants|||Number
1248136|NCT00524576|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period (Day 0-30) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. This table describes SAEs reported by all subjects except for those enrolled in the Australian center.|||participants|||Number
1248137|NCT00524576|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period (Day 0-30) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
1248138|NCT00524576|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache.|During the 4-day follow-up period (Day 0-3) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
1248139|NCT00524576|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day follow-up period (Day 0-3) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
1248140|NCT00524576|Secondary|Concentration of Anti-HBs Antibodies|Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.|||mIU/mL||95% Confidence Interval|Geometric Mean
1248141|NCT00524576|Secondary|Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
1248142|NCT00524576|Primary|Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|"Immune response defined as:~For initially seronegative subjects (anti-HBs antibody concentration <3.3 milli-international unit per milliliter [mIU/mL] before vaccination) antibody concentration ≥ 10mIU/mL at post booster.~For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration."|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
1248143|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit|"The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for total days in hospital at given timepoint."|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|"All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for total days in hospital."|||total days in hospital||Standard Deviation|Mean
1248144|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit|"The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for total days in hospital and at least one admission to hospital at given timepoint.."|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|"All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for total days in hospital and at least one admission to hospital."|||number of admissions to hospital||Standard Deviation|Mean
1248145|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at emergency room.|||number of visits at emergency room||Standard Deviation|Mean
1248146|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at physician's office.|||number of visits at physician's office||Standard Deviation|Mean
1248147|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn’s Disease From Baseline to Each Visit|Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.|||percentage of activity impairment||Standard Deviation|Mean
1248148|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn’s Disease From Baseline to Each Visit|The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)* [number of hours worked / (number of hours of work missed due to CD + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.|||percentage of overall work impairment||Standard Deviation|Mean
1248149|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn’s Disease From Baseline to Each Visit|Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.|||percentage of impairment while working||Standard Deviation|Mean
1248150|NCT00524537|Secondary|Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit|Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.|||percentage of work time missed||Standard Deviation|Mean
1248151|NCT00524537|Secondary|Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit|The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with PGA measurements.|||units on a scale||Standard Deviation|Mean
1248152|NCT00524537|Secondary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit|The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with SIBDQ measurements.|||units on a scale||Standard Deviation|Mean
1248170|NCT00524459|Secondary|Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy||Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1248171|NCT00524459|Secondary|Overall Clinical Local Regional Response||Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1248172|NCT00524459|Primary|Clinical Complete Response||Surgery done after completion of six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1248153|NCT00524537|Primary|Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~For more details on adverse events please see the AE section below."|Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).|All Treated Population: All participants who received at least 1 injection of Humira in the registry|||Participants|||Count of Participants
1248154|NCT00524511|Secondary|Patient Satisfaction of Cosmesis of Surgical Wound|survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)|before hospital discharge after surgery|No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.||||||
1248155|NCT00524511|Primary|Wound Complication Rate|Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound|within six weeks of study intervention|No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.||||||
1248156|NCT00524485|Secondary|Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
1248157|NCT00524485|Secondary|PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
1248158|NCT00524485|Secondary|Histological Response|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
1248159|NCT00524485|Secondary|Effects of Different Treatment Conditions on Efficacy|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
1248160|NCT00524485|Secondary|Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
1248161|NCT00524485|Primary|Extent That the PpIX is Photobleached by the Treatment Light|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
1248162|NCT00524485|Primary|Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
1248163|NCT00524472|Secondary|a Composite of Minor Postoperative Complications|a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days.|within 30 days after surgery||||Participants|||Count of Participants
1248164|NCT00524472|Secondary|All-cause Mortality|All-cause mortality identified during one-year follow-up.|one year post operative||||Participants|||Count of Participants
1248165|NCT00524472|Secondary|Duration of Intensive Care Stay|Hours from date of surgery to discharge from intensive care unit|ICU stay hours during hospital stay after surgery, on average of 25 hours||||hours||95% Confidence Interval|Median
1248166|NCT00524472|Secondary|Duration of Hospitalization|Days from date of surgery to hospital discharge|starting post operative day one to discharge from hospital, on an average of 8 days||||days||95% Confidence Interval|Median
1248167|NCT00524472|Secondary|Post Operative Atrial Fibrillation|Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery|15 - 30 days post operative||||Participants|||Count of Participants
1248168|NCT00524472|Primary|Any Major Morbidity/30-day Mortality|"a composite (any versus none) of the following major postoperative complications occurring:~all-cause postoperative mortality~failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation~serious postoperative infection~acute postoperative kidney injury requiring renal replacement therapy;~new postoperative focal or global neurologic deficit."|within 30 days post surgery||||Participants|||Count of Participants
1248169|NCT00524459|Secondary|Safety, in Terms of Neutropenia and Cardiac Toxicity||Every cycle during study treatment and 8 weeks post-treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1248174|NCT00524420|Secondary|Adverse Events|Adverse events (AEs) were collected by open report of emergent symptoms or illness during the study. This form is filled out during baseline, daily before each TMS session by the trained physician administering the TMS, and at each follow-up visit.|Measured daily||||number of adverse events|||Number
1248175|NCT00524420|Secondary|Hamilton Depression Rating Scale|The research coordinator administered the Hamilton Depression Rating Scale-17 item to assess the level of depression on a weekly basis at baseline, weeks 1, 2, 3 of TMS treatment and 1 week post-TMS treatment. Higher scores indicate a higher level of depression. Scores range from 0-50 and scores greater than 20 generally indicate moderate depression. Scores between 0-7 are considered normal.|Measured weekly||||units on a scale||Standard Deviation|Mean
1248176|NCT00524420|Secondary|Gracely Box Unpleasantness Scale|The BURS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain unpleasantness over time. Each scale is a 20 point scale that has clear anchor points. Pain unpleasantness is different from pain intensity in that it assesses the affective and not the somatic aspect of the pain. Lower scores indicate less unpleasantness of pain and higher scores indicate more unpleasantness of pain. This measure was administered at Baseline, after weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS.|Measured weekly||||units on a scale||Standard Deviation|Mean
1248177|NCT00524420|Primary|Gracely Box Intensity Rating Scale|The BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.|Measured weekly||||units on a scale||Standard Deviation|Mean
1248178|NCT00524394|Primary|Cytokines|IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .|O TO 30 DAYS OF LIFE|zero participant analyzed||||||
1248179|NCT00524394|Primary|Immunological Homeostasis|"Describe changes in immunological homeostasis that indicate the normal function vs. presence of sepsis in newborn infants of various gestational ages"|0 to 30 days of life.|||||||
1248180|NCT00524368|Secondary|Number of Participants Developing Mutations at Endpoint|Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.|48 weeks|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.|||Participants|||Number
1248181|NCT00524368|Secondary|Predose Plasma Concentration (C0h) of DRV and Rtv.|Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.|0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
1248182|NCT00524368|Secondary|Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv|Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.|0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.|||ng*h/mL||Full Range|Median
1248183|NCT00524368|Secondary|Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48|Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.|48 weeks|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.|||Percentage of participants|||Number
1248184|NCT00524368|Secondary|Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score|The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.|48 weeks|Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.|||Scores on a scale||Full Range|Median
1248185|NCT00524368|Secondary|Change in CD4+ Cell Count From Baseline|CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.|48 Weeks|Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.|||10e6/l||Full Range|Median
1248186|NCT00524368|Secondary|Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks||48 weeks|Intention To Treat (ITT) population: Observed cases|||log10 copies/mL||Standard Error|Least Squares Mean
1248187|NCT00524368|Secondary|Time to Loss of Virologic Response|Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||Days||Standard Error|Mean
1248188|NCT00524368|Secondary|Time to Reach First Virologic Response|Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||Days||Full Range|Median
1248189|NCT00524368|Secondary|Change in log10 Viral Load From Baseline at Week 48||48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||log10 copies/mL||Full Range|Median
1248190|NCT00524368|Secondary|Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)|Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||Participants|||Number
1248191|NCT00524368|Primary|Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|48 Weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||Participants|||Number
1248192|NCT00524342|Secondary|No. of Subjects With IL-11 Associated Adverse Events.|The number of subjects with IL-11 associated adverse events.|The time frame is up to 7 months per subject.||||participants|||Number
1248193|NCT00524342|Secondary|No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA).|No. of subjects with detectable VWFmRNA, a measure of IL-11 (interleukin-11) function, specifically increasing VWF synthesis.|The time frame is up to 7 months per subject.||||participants|||Number
1248194|NCT00524342|Primary|>50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months|Subjective estimate of blood loss was measured by using a Pictorial blood assessment chart (PBAC) . The PBAC measures scores on a scale where 0 to 100 is normal and greater than 100-200 are abnormal.|6 months||||percentage of participants|||Number
1248195|NCT00524316|Secondary|Tumor Marker Response (AFP)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, week 7 and every 6 weeks after|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1248196|NCT00524316|Secondary|Assess the Change in the Quality of Life Among Patients Using the FACTHep (Version 4) for Hepatobiliary Cancers.|"We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores reflect better quality of life.~No subscales were analyzed."|Baseline and Cycle 2|All treated and eligible patients|||units on a scale||Standard Deviation|Mean
1248197|NCT00524316|Secondary|Safety and Tolerability|"Number of participants with adverse advent.~Please refer to adverse event reporting for more detail."|Daily while on treatment through study completion, an average of 1 year|All treated and eligible patients|||participants|||Number
1248198|NCT00524316|Secondary|Tissue Perfusion, Ktrans, IAUC, and Percent Viable Tumor as Measured by DCE-MRI at Baseline and on Days 8 (Before Transarterial Chemoembolization), 10, and 35||Baseline, day 8, day 10, day 28 and day 35|Due to the study's early termination and inadequate number of patients, no data were collected for this Outcome Measure.||||||
1248199|NCT00524316|Secondary|Overall Survival|median survival in months|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|All treated and eligible patients|||months||95% Confidence Interval|Median
1248200|NCT00524316|Primary|Progression-free Survival|median progression free survival in months|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|All treated and eligible patients.|||months||95% Confidence Interval|Median
1248201|NCT00524303|Other Pre-specified|Transcriptional Profiling of Total RNA and the Correlation to Response/Non-response to Treatment|Transcriptional data were of poor quality and thus could not be analyzed. Gene pathways that correlate with response/non-response to treatment were to have been evaluated. The unit of measure is unit less; however, the processed values would be considered normalized relative expression level.|Tumor core biopsy taken at Baseline and Treatment Day 14|||||||
1248202|NCT00524303|Other Pre-specified|Cancer Stem Cells and the Correlation to Response/Non-response to Treatment|Stem cell data were of poor quality and thus could not be analyzed. Increases or decreases in cancer stem cells and how the changes correlated with response/non-response to treatment were to have been assessed.|Tumor core biopsy taken at Baseline and Treatment Day 14|||||||
1248203|NCT00524303|Other Pre-specified|Mean Intra-tumoral Expression of the Indicated Proteins at Baseline and Day 14|Expression (exp) of biomarker proteins (prot) were analyzed to determine if individual prot levels either in the Baseline or Day 14 breast tumor biopsy specimen correlated with breast pCR. A biomarker indicates a change in exp or state of a prot that correlates with the risk or disease progression, or with the susceptibility of the disease to a given treatment. Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like blood or tissue. pCR=yes: participants (par.) had breast pCR. pCR=no: par. did not have breast pCR. Prot exp values are represented as normalized, scaled values; the unit of measurement is unit-less. Raw exp values were processed as follows: background subtraction of the raw exp value, then that value divided by beta-acting exp to normalize the exp value. A Standard Z score was calculated to scale the exp value.|Tumor core biopsy taken at Baseline and Treatment Day 14|ITT-E Population. Only those participants with matched pairs of biopsy samples for analysis at Baseline and on Day 14 were analyzed.|||: normalized relative expression level||Standard Deviation|Mean
1248204|NCT00524303|Secondary|Cumulative Number of Participants With at Least One Decrease of More Than or Equal to 20% in Left Ventricular Ejection Fraction (LVEF) at the Indicated Time Points Compared to LVEF at Baseline|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function. LVEF was measured by performing echocardiogram (ECHO). If ECHO could not be performed or if the investigator believed that it was not conclusive to evaluate LVEF, then a multigated acquisition (MUGA) scan was performed.|Weeks 3, 9, and 15; EOT or early withdrawal; and 3- and 6-month survival follow-up after last chemotherapy course|Safety Population. Not all participants in the Safety Population were analyzed: some participants were randomized to an arm they did not want or participants were randomized in error (eligibility criteria weren’t met).|||participants|||Number
1248205|NCT00524303|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Status at Baseline and at EOT or Early Withdrawal|12-lead ECGs were performed, and participants were classified as having normal ECG, abnormal- not clinically significant (NCS) ECG, and abnormal-clinically significant (CS) ECG per investigator opinion and reported result.|Baseline and EOT (up to Week 26) or Early withdrawal|Safety Population: all randomized participants (par) who received at least one dose of investigational product, based on actual treatment received if this differed from that to which par was randomized. Not all par were analyzed: some par were randomized to an arm they did not want or par were randomized in error (eligibility criteria weren’t met).|||participants|||Number
1248206|NCT00524303|Secondary|Percentage of Participants (Par.) With Disease-free Survival (DFS) at the End of 5 Years From Randomization|Percentage is the Kaplan Meier estimate of DFS. DFS is time from randomization until disease recurrence (contralateral breast cancer; second primary cancer; progression during neo-adjuvant treatment; or death from any cause). Par. who experienced progression during treatment and were withdrawn were considered to have a DFS event at withdrawal.|From first dose date until disease progression, assessed up to a maximum of 5 years|ITT Population|||Percentage||95% Confidence Interval|Number
1248207|NCT00524303|Secondary|Percentage of Participants With Clinical Complete Response (cCR) at 26 Weeks or at End of Treatment (EOT) or Early Withdrawal|cCR was defined as the percentage of participants achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Week 26 or EOT or Early withdrawal|ITT Population: all randomized participants regardless of whether they had received any treatment.|||percentage of participants|||Number
1248208|NCT00524303|Primary|Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy|A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.|Week 26|Intent-to-Treat-Evaluable (ITT-E) Population: ITT participants with evaluable tumor responses who had been >=75% compliant to 5-fluorouracil (5-FU) 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 (FEC75) and paclitaxel 80 mg/m^2 and had undergone surgery.|||percentage of participants|||Number
1248209|NCT00524264|Post-Hoc|Visual Acuity|Patients with ≥ 3 line improvement in visual acuity|Change from baseline at Day 14|Modified Intent-to-Treat Population|||Percentage of patients with ≥ 3 lines|||Number
1248210|NCT00524264|Secondary|Mean Pupil Area|Pupil area post-irrigation and aspiration|Day 0|Modified Intent-to-Treat Population|||millimeters squared (mm²)||Standard Deviation|Mean
1248211|NCT00524264|Secondary|Ocular Pain|Measured on a scale of 0-4 (0 = none, 4 = intolerable)|Day 1|Modified Intent-to-Treat Population|||% of participants with a score of 0|||Number
1248212|NCT00524264|Primary|Resolution of Post Operative Inflammation|Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)|Day 14|Modified Intent-to-Treat Population|||% of participants with a score of 0|||Number
1248213|NCT00524225|Secondary|Number of Participants|mild headache, nausea|The time frame is within 4 weeks of surgery.||||participants|||Number
1248214|NCT00524225|Secondary|No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).|The number of subjects with detectable VWFmRNA.|4 weeks per subject|Even though three subjects were enrolled, none were assessed for VWFmRNA because the study stopped due to poor enrollment related to insurers requiring surgeries outside of UPMC.||||||
1248215|NCT00524225|Primary|Volume of Blood Transfusion|The volume of blood transfusion required (units of blood) after the surgical procedure.|4 weeks||||units of blood|||Number
1248216|NCT00524225|Primary|Volume of Surgical Blood Loss|Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.|4 weeks||||cc|||Number
1248217|NCT00524173|Secondary|Loss of HBsAg||192 weeks||||Participants|||Count of Participants
1248218|NCT00524173|Secondary|Number of Participants With Normalized ALT|Number of participants with normalized ALT|192 weeks||||Participants|||Count of Participants
1248219|NCT00524173|Primary|Number of Participants With HBV DNA <1000 IU/ml at Week 192|Number of participants with HBV DNA <1000 IU/ml at Week 192|At Week 192||||Participants|||Count of Participants
1248220|NCT00524173|Primary|Number of Subjects With HBV DNA <1000 IU/ml at Week 48|Number of subjects with HBV DNA <1000 IU/ml at Week 48|At Week 48||||Participants|||Count of Participants
1248221|NCT00524134|Secondary|Prevalence of Medication Retention/Treatment Failure||16 weeks|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.||||||
1248222|NCT00524134|Secondary|Prevalence of Seizure Freedom||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.||||||
1248223|NCT00524134|Secondary|Percent Change in Total Seizure Count Between Treatment Arms||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.||||||
1248224|NCT00524134|Primary|Proportion of Each Treatment Arm With ≥50% Reduction in Seizures||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.||||||
1248225|NCT00524121|Secondary|Response by EGFR Mutation Status||Radiologic evaluation every 3 months, up to 5 years||||participants|||Number
1248226|NCT00524121|Secondary|Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression||Radiologic evaluation every 3 months, up to 5 years||||participants|||Number
1248227|NCT00524121|Secondary|Response by Epidermal Growth Factor Receptor (EGFR) Expression||Radiologic evaluation every 3 months, up to 5 years||||participants|||Number
1248228|NCT00524121|Secondary|Correlation of Smoking Status With Overall Survival||5 years|Patients Treated with Study Therapy|||months||95% Confidence Interval|Median
1248229|NCT00524121|Secondary|Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale|Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes|Baseline and Week 3|Patients Treated with Study Therapy and with FACT-E scores available|||FACT-E Score||Full Range|Median
1248230|NCT00524121|Secondary|Progresssion-Free Survival|Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 3 months, up to 5 years||||months||95% Confidence Interval|Median
1248231|NCT00524121|Secondary|Complete Response|"Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation.~Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor."|4-8 weeks after completion of radiation.|Patients Treated with Study Therapy|||percentage of participants||95% Confidence Interval|Number
1248232|NCT00524121|Primary|Overall Survival||5 years||||months||95% Confidence Interval|Median
1248233|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score|The MOS SF-36 is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1248234|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score|The Medical Outcomes Study Short Form Health Survey-36 (MOS SF-36) is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1248235|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score|The Personal and Social Performance (PSP) scale assesses the degree of difficulty (ranging from i [absent] to vi [very severe]) a patient exhibits over a 1-month period in socially useful activities, personal and social relationships, self care, and disturbing and aggressive behavior. The overall score ranges from 1 to 100. Patients with scores of 71 to 100 have a mild degree of difficulty; patients with scores from 31 to 70 have various degrees of disability; and patients with scores of 30 or less function so poorly as to require intensive supervision.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1248236|NCT00524043|Secondary|Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S|The Clinical Global Impression-Severity (CGI-S) rating scale is used by psychiatrists to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). The scale permits a global evaluation of the patient's condition at a given time.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Full Range|Median
1248251|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 4)|Change from baseline in number of steps per day (week 4)|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
1248237|NCT00524043|Primary|Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment).|The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1248238|NCT00524030|Secondary|Pregabalin Exposure-Response Analysis|Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates.|Day 126|MITT Full Study Set|||Percentage of Participants|||Number
1248239|NCT00524030|Secondary|Pregabalin Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Baseline up to 20 weeks|||||||
1248240|NCT00524030|Secondary|Percentage of Seizure-Free Participants by Study Phase|Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140)|Day 1 up to Day 140|MITT Full Study Set|||Percentage of Participants|||Number
1248241|NCT00524030|Secondary|Mean Time on Pregabalin Monotherapy||Week 2 to Week 20|MITT Full Study Set; N=number of participants entering Monotherapy Period|||Days||Standard Deviation|Mean
1248242|NCT00524030|Secondary|Percentage of Participants Who Met Protocol-Specified Exit Events|Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity|Week 2 up to Week 18|MITT Efficacy Set|||Percentage of Participants|||Number
1248243|NCT00524030|Secondary|Percentage of Participants Completing 20 Weeks of Double-Blind Treatment||Randomization up to Week 20|MITT Full Study Set|||Percentage of Participants|||Number
1248244|NCT00524030|Secondary|Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria|Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100%|Week 2 up to Week 18|MITT Full Study Set: all randomized participants who met the MITT definition (received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2)|||Percentage of Participants||95% Confidence Interval|Number
1248245|NCT00524030|Primary|Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria|Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100%|Week 2 up to Week 18|Modified Intent to Treat (MITT) Efficacy Set: The first 125 participants randomized who received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2. Number of participants analyzed (N)= number of MITT participants with discontinuation/completion data.|||Percentage of Participants||95% Confidence Interval|Number
1248246|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 24)|Change from baseline in number of steps per day (week 24)|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
1248247|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 20)|Change from baseline in number of steps per day (week 20)|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
1248248|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 16)|Change from baseline in number of steps per day (week 16)|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
1248249|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 12)|Change from baseline in Number of steps per day (week 12)|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
1248250|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day(Week 8)|Change from baseline in number of steps per day (week 8)|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
1248252|NCT00523991|Secondary|Number of Steps Per Day (Baseline)|Number of steps per day (baseline)|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Deviation|Mean
1248253|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 24)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
1248254|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 20)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
1248255|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 16)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
1248256|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 12)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
1248257|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 8)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
1248258|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 4)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
1248259|NCT00523991|Secondary|Active Energy Expenditure (Baseline)|The amount of energy (kcal/day) that a person uses while physically active.|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Deviation|Mean
1248260|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 24)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
1248261|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 20)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
1248262|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 16)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
1248263|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 12)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
1248264|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 8)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
1248265|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 4)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
1248266|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Baseline)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
1248330|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)|Change from baseline in forced vital capacity (week 16, 30 minutes)|baseline, week 16, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248267|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248268|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248269|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248270|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248271|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248272|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248273|NCT00523991|Secondary|Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Deviation|Mean
1248274|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248861|NCT00519779|Secondary|ln(Beck Anxiety Score)|log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||units||Standard Error|Least Squares Mean
1248275|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248276|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248277|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity defined as less than three metabolic equivalents.~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248278|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248279|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
1248280|NCT00523991|Secondary|Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents.~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm."|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Deviation|Mean
1248281|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248282|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248331|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)|Change from baseline in forced vital capacity (week 16, pre-dose)|baseline, week 16, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248283|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248284|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248285|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248286|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248287|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Deviation|Mean
1248288|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248289|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248326|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)|Change from baseline in forced vital capacity (week 24, pre-dose)|baseline, week 24, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248421|NCT00523549|Secondary|Percent Change From Baseline in Vascular Stiffness|Percent change from baseline in Vascular Stiffness (measured by radial augmentation index [AI]) at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat|||percentage of change in mean AI||Standard Deviation|Mean
1248290|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248291|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248292|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248293|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248294|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Deviation|Mean
1248295|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248296|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248327|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)|Change from baseline in forced vital capacity (week 16, 180 minutes)|baseline, week 16, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248928|NCT00519090|Primary|Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib|Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.|12 months||||percent of participants|||Number
1248297|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248298|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248299|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248300|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248301|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Deviation|Mean
1248302|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248303|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248328|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)|Change from baseline in forced vital capacity (week 16, 120 minutes)|baseline, week 16, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248422|NCT00523549|Secondary|Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity|Change from baseline in peak E-wave velocity / lateral mitral annular myocardial relaxation velocity (E/E’) at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat|||ratio||Standard Deviation|Mean
1248304|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248305|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248306|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248307|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
1248308|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Deviation|Mean
1248309|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
1248310|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
1248311|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
1248329|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)|Change from baseline in forced vital capacity (week 16, 60 minutes)|baseline, week 16, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248312|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
1248313|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
1248314|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
1248315|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 24)|Difference in number of days that participants used albuterol prn per week between week 24 and baseline|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Error|Least Squares Mean
1248316|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. -(Week 20)|Difference in number of days that participants used albuterol prn per week between week 20 and baseline|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
1248317|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 16)|Difference in number of days that participants used albuterol prn per week between week 16 and baseline|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
1248318|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. -(Week 12)|Difference in number of days that participants used albuterol prn per week between week 12 and baseline|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
1248319|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 8)|Difference in number of days that participants used albuterol prn per week between week 8 and baseline|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
1248320|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 4)|Difference in number of days that participants used albuterol prn per week between week 4 and baseline|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
1248321|NCT00523991|Secondary|Albuterol Use p.r.n. (Baseline)|Number of days that participants used albuterol prn per week|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
1248322|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)|Change from baseline in forced vital capacity (week 24, 180 minutes)|baseline, week 24, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248323|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)|Change from baseline in forced vital capacity (week 24, 120 minutes)|baseline, week 24, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248324|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)|Change from baseline in forced vital capacity (week 24, 60 minutes)|baseline, week 24, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248325|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)|Change from baseline in forced vital capacity (week 24, 30 minutes)|baseline, week 24, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248423|NCT00523549|Secondary|Change in Left Atrial Size|Change from baseline in left atrial size at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat|||cm||Standard Deviation|Mean
1248332|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)|Change from baseline in forced vital capacity (week 8, 180 minutes)|baseline, week 8, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248333|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)|Change from baseline in forced vital capacity (week 8, 120 minutes)|baseline, week 8, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248334|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)|Change from baseline in forced vital capacity (week 8, 60 minutes)|baseline, week 8, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248335|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)|Change from baseline in forced vital capacity (week 8, 30 minutes)|baseline, week 8, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248336|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)|Change from baseline in forced vital capacity (week 8, pre-dose)|baseline, week 8, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248337|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 180 Minutes)|Forced vital capacity (baseline, 180 minutes)|baseline, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248338|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 120 Minutes)|Forced vital capacity (baseline, 120 minutes)|baseline, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248339|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 60 Minutes)|Forced vital capacity (baseline, 60 minutes)|baseline, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248340|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 30 Minutes)|Forced vital capacity (baseline, 30 minutes)|baseline, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248341|NCT00523991|Secondary|Forced Vital Capacity (Baseline, Pre-dose)|Forced vital capacity (baseline, pre-dose)|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248342|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 24)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248343|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 16)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248344|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 8)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248345|NCT00523991|Secondary|Peak Forced Vital Capacity (FVC) (Baseline)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248346|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 24)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248347|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 16)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248424|NCT00523549|Primary|Change in Lateral Mitral Annular Myocardial Relaxation Velocity|Change from baseline in lateral mitral annular myocardial relaxation velocity (E’) at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat|||cm/s||Standard Deviation|Mean
1248348|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 8)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248349|NCT00523991|Secondary|Trough Forced Vital Capacity (Baseline)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248350|NCT00523991|Secondary|FVC AUC0-3 at Week 24 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Error|Least Squares Mean
1248351|NCT00523991|Secondary|FVC AUC0-3 at Week 16 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Deviation|Mean
1248352|NCT00523991|Secondary|FVC AUC0-3 at Week 8 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Deviation|Mean
1248353|NCT00523991|Secondary|FVC AUC0-3 at Baseline|Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Deviation|Mean
1248354|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)|baseline, week 24, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248355|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)|baseline, week 24, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248356|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)|baseline, week 24, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248357|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)|baseline, week 24, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248358|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)|baseline, week 24, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248359|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)|baseline, week 16, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248360|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)|baseline, week 16, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248361|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)|baseline, week 16, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248362|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)|Baseline, week 16, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248425|NCT00523419|Secondary|Overall Survival (OS) Time|OS was the duration from enrollment to death. For participants who lived, OS was censored at the last contact.|Baseline to 27.6 months|Full analysis population: all participants who were treated with at least one dose of the study regimen.|||months||95% Confidence Interval|Median
1248363|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)|Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)|baseline, week 16, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248364|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)|baseline, week 8, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248365|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)|baseline, week 8, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248366|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)|baseline, week 8, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248367|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)|Baseline, week 8, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248368|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)|Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)|baseline, week 8, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248369|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)|Forced expiratory volume in 1 second (baseline, 180 minutes)|Baseline, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248370|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)|Forced expiratory volume in 1 second (baseline, 120 minutes)|Baseline, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248371|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)|Forced expiratory volume in 1 second (baseline, 60 minutes)|baseline, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248372|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)|Forced expiratory volume in 1 second (baseline, 30 minutes)|baseline, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248373|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)|Forced expiratory volume in 1 second (baseline, pre-dose)|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248374|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248375|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248376|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248377|NCT00523991|Secondary|Peak Forced Expiratory Volume in 1 Second (Baseline)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248378|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
1248379|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248380|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248381|NCT00523991|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
1248382|NCT00523991|Primary|Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)|Change = Week 24 Value – Baseline Value|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Error|Least Squares Mean
1248383|NCT00523978|Primary|Cryoablation Procedure Events (CPEs)|Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death.|To end of ablation procedure|Data for subjects who were randomized to the Experimental group and received cryoablation therapy were included in this analysis. All CPEs reported in the Experimental group were included in the analysis regardless of their association with the first or a repeat cryoablation.|||participants|||Number
1248384|NCT00523978|Primary|Freedom From Major Atrial Fibrillation Events (MAFEs)|Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.|12 Months|mITT set included all subjects (82 CS, 163 ES) who were enrolled, randomized, and received treatment.|||participants|||Number
1248385|NCT00523978|Primary|Treatment Success|Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration.|12 months|The mITT population consisted of all subjects, who were enrolled, randomized and received treatment|||participants|||Number
1248386|NCT00523978|Primary|Freedom From Chronic Treatment Failure (CTF)|Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.|12 month follow up period|This section includes data for subjects who were randomized, received treatment and were followed through 12-Months post randomized treatment regardless of AF Drug usage. Subjects who experienced Acute Procedural Failure in the Experimental group were not included in this analysis of post-procedural failure causes.|||participants|||Number
1248387|NCT00523978|Primary|Acute Procedural Success (APS)|Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame.|371.4 Minutes (Average)|Subjects evaluated were from the modified Intent to Treat subset (mITT)or subjects that were enrolled, randomized and received treatment.|||participants|||Number
1248388|NCT00523939|Secondary|Time to Neurologic Progression||2 years|||||||
1248389|NCT00523939|Primary|Response Rate|To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.|1 year|Primary outcome measure was not assessed due to early study termination.||||||
1248390|NCT00523848|Secondary|Time to Disease Progression||Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first||||months||95% Confidence Interval|Median
1248391|NCT00523848|Secondary|Complete Response Rate||Every 3 months|Evaluable patients.|||percentage of participants||95% Confidence Interval|Number
1248392|NCT00523848|Primary|Overall Response Rate (Complete and Partial)||Every 3 months|Evaluable patients|||percentage of participants||95% Confidence Interval|Number
1248393|NCT00523809|Primary|Progression-free Survival (PFS)|Number or participants with no disease progression or death for any reason during first 100 days following transplantation. Participants followed every 3 months for first year.|100 days after transplant|Study objectives were not meet, analysis was not performed.||||||
1248394|NCT00523744|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.|Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||Percentage of participants|||Number
1248395|NCT00523744|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study|Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||Percentage of participants|||Number
1248396|NCT00523744|Secondary|Change in Sitting Pulse Rate During the Extension Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||BPM (beats per minute)||95% Confidence Interval|Mean
1248397|NCT00523744|Secondary|Change in Sitting Pulse Pressure During the Extension Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||mmHg||95% Confidence Interval|Mean
1248398|NCT00523744|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||mmHg||95% Confidence Interval|Mean
1248399|NCT00523744|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||Percentage of participants|||Number
1248400|NCT00523744|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||Percentage of participants|||Number
1248401|NCT00523744|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||mmHg||95% Confidence Interval|Mean
1248402|NCT00523744|Secondary|Change in Sitting Pulse Rate During the Core Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||BPM (beats per minute)||95% Confidence Interval|Mean
1248403|NCT00523744|Secondary|Change in Sitting Pulse Pressure During the Core Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
1248426|NCT00523419|Secondary|Progression-Free Survival (PFS)|PFS was from date of study enrollment to first date of objectively determined progressive disease (PD) or death from any cause. For participants who did not die as of data cut-off date and who did not have objective PD, PFS was censored at date of last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from study drug) before objectively determined disease progression or death, PFS was censored at date of last objective progression-free disease assessment, before post-discontinuation chemotherapy.|Baseline to 10.4 months|Full analysis population: all participants who were treated with at least one dose of the study regimen.|||months||95% Confidence Interval|Median
1248404|NCT00523744|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
1248405|NCT00523744|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
1248406|NCT00523718|Secondary|Clinical Global Impression (CGI) - Severity of Illness Item|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|14 weeks||||units on a scale||Standard Deviation|Mean
1248407|NCT00523718|Secondary|Average Hamilton Anxiety Inventory (HAM-A)|The Hamilton Anxiety Rating Scale (HARS or HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score ranges from 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. A score of 31 or greater represents very severe anxiety severity.|14 weeks||||units on a scale||Standard Deviation|Mean
1248408|NCT00523718|Secondary|Average Hamilton Depression Inventory (HAM-D)|"The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The HAM-D 17-item scale ranges from 0 (normal) to >23 (very severe depression), with a maximum score of 52. The 24-item scale has a maximum score of 75. Severity of depression (e.g. normal or very severe) is based upon the score in the first 17-items."|14 weeks||||units on a scale||Standard Deviation|Mean
1248409|NCT00523718|Primary|Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)|"The Yale–Brown Obsessive Compulsive Scale (Y-BOCS) is a test to rate the severity of obsessive–compulsive disorder (OCD) symptoms. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The results can be interpreted based on the total score:~0–7 is sub-clinical; 8–15 is mild; 16–23 is moderate; 24–31 is severe; 32–40 is extreme.~Improvement was defined apriori as a 25% improvement from baseline"|14 weeks||||participants|||Number
1248410|NCT00523705|Secondary|Subject Satisfaction Questionnaire||Study endpoint|Not analyzed due to small number of subjects.||||||
1248411|NCT00523705|Secondary|Patient Global Evaluation of Improvement (PGE)||Throughout treatment|Not analyzed due to small number of subjects||||||
1248412|NCT00523705|Secondary|Sheehan Disability Scale (SDS)||Throughout study|Data not analyzed due to only 11 subjects.||||||
1248413|NCT00523705|Primary|Subject Daily Symptom Rating Score.|A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.|baseline and 5 months.||||units on a scale||Standard Deviation|Mean
1248414|NCT00523640|Secondary|Overall Survival|Time from enrollment until death from any cause.|60 months||||months||95% Confidence Interval|Median
1248415|NCT00523640|Primary|Progression-free Survival|Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline|60 months||||months||95% Confidence Interval|Median
1248416|NCT00523640|Primary|Objective Response Rate|Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.|12 weeks||||proportion|||Number
1248417|NCT00523614|Primary|Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)|The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy.|01/2002 - 01/2008||||Participants|||Number
1248418|NCT00523549|Secondary|Change in Estimated Central Aortic Pressure|Change from baseline in estimated central aortic pressure at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat|||mm Hg||Standard Deviation|Mean
1248419|NCT00523549|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)|Change from baseline in msDBP at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat population|||mm Hg||Standard Deviation|Mean
1248420|NCT00523549|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)|Change from baseline in msSBP at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat|||mm Hg||Standard Deviation|Mean
1248427|NCT00523419|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from the first objective status assessment of CR or PR to the first date of progression or death as a result of any cause: CR was achieved if all tumor lesions disappeared; PR was achieved if there was >=30% decrease in sum of the longest diameter (LD) of target lesions (reference: baseline sum LDs) or complete disappearance of target lesions with persistence (but not worsening) of >=1 nontarget lesions and no appearance of new lesions.|Baseline to 31 months|Tumor response population: participants with best overall response of complete response (CR) and partial response (PR).|||months|||Number
1248428|NCT00523419|Secondary|Number of Participants With Adverse Events (Pharmacology Toxicity)|Pharmacology toxicity was defined as serious and non-serious adverse events. Summaries of these adverse events are located in the Reported Adverse Event Section.|Baseline to 21 months|Full analysis population: all participants who were treated with at least one dose of the study regimen|||participants|||Number
1248429|NCT00523419|Secondary|Correlation of Disease Outcome With Pharmacogenomic Analysis|It was planned to examine methylthioadenosine phosphorylase (MTAP) gene deletion, folate receptor alpha (FRα) and folylpoly-gamma-glutamate synthetase (FPGS) expression, and to correlate the results with the clinical data to determine the association between these factors and clinical outcome to treatment. However, due to the small number of participants with partial response (n=1), the planned statistical analyses that would correlate responders/non responders with pharmacogenomics data are no longer valid and the analyses were not conducted.|Baseline to 21 months|Since this outcome measure was not analyzed due to the inadequate number of responders, zero participants were analyzed.|||correlation coefficient|||Number
1248430|NCT00523419|Secondary|Time to Treatment Failure|When the protocol was written, time to treatment failure (TTTF) was included as a secondary endpoint. However, it was subsequently realized that due to the design of the study, participants are treated until disease progression or discontinuation from study treatment, not for a fixed number of cycles. Therefore, it was concluded that analysis of TTTF was inappropriate with the current study design and the analysis was not conducted, since it would be essentially the same as Progression-Free Survival.|Baseline to 21 months|Since this outcome measure was not analyzed due to the study design, zero participants were analyzed.|||days||Standard Deviation|Mean
1248431|NCT00523419|Primary|Percentage of Participants With Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis * 100.|Baseline to 21 months|Participants who qualified for tumor response analysis are those with histological evidence of high grade locally advanced or metastatic osteosarcoma and treatment with at least 1 dose of study drug. Three participants died before the first tumor assessment and 1 participant discontinued without any tumor assessments and were considered Unknown.|||percentage of participants||95% Confidence Interval|Number
1248432|NCT00523367|Secondary|COPD/GERD Patients Treated With High Dose Esomeprazole|COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.|1 year|||||||
1248433|NCT00523367|Primary|Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.|The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.|1 year||||participants|||Number
1248434|NCT00523341|Secondary|Bone Histology at Month 84|Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.|Month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 84.|||biopsies|biopsies||Number
1248435|NCT00523341|Secondary|Bone Histology at Month 24|Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.|Month 24|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 24.|||biopsies|biopsies||Number
1248436|NCT00523341|Secondary|Bone Histomorphometry: Mineralization Lag Time|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken.~Mineralization lag time is the average time interval between osteoid formation and its subsequent mineralization and is calculated by dividing the osteoid width by the apposition rate."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralization lag time data.|||days||Standard Deviation|Mean
1248437|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Volume|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoid volume is the percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid volume data.|||percentage of total bone tissue||Standard Deviation|Mean
1248539|NCT00522418|Secondary|Changes in Anti-epileptic Drugs (AEDs)|Change from baseline in number of AED medications by visit|Change from baseline in number of AEDs at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for fifty-nine (59) patients.|||Number of AEDs Taken||Full Range|Median
1248438|NCT00523341|Secondary|Bone Histomorphometry: Activation Frequency|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency. Activation frequency is calculated as the bone formation rate / wall width."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available activation frequency data.|||/year||Standard Deviation|Mean
1248439|NCT00523341|Secondary|Bone Histomorphometry: Formation Period|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Formation period (FP) is the mean time required to rebuild a new bone structural unit or osteon from the cement line back to the bone surface at a single location, and is given by wall width / adjusted apposition rate."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available formation period data.|||days||Standard Deviation|Mean
1248440|NCT00523341|Secondary|Bone Histomorphometry: Bone Formation Rate - Volume Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - volume based is the calculated rate at which cancellous bone volume is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.|||percent of bone volume per year||Standard Deviation|Mean
1248441|NCT00523341|Secondary|Bone Histomorphometry: Bone Formation Rate - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - surface based is the calculated rate at which cancellous bone surface is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone surface)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.|||μm³/μm²/year||Standard Deviation|Mean
1248442|NCT00523341|Secondary|Bone Histomorphometry: Adjusted Apposition Rate|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the average rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available adjusted apposition rate data.|||μm/day||Standard Deviation|Mean
1248443|NCT00523341|Secondary|Bone Histomorphometry: Mineral Apposition Rate|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineral apposition rate data.|||μm/day||Standard Deviation|Mean
1248444|NCT00523341|Secondary|Bone Histomorphometry: Mineralizing Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralizing surface data.|||percentage of bone surface||Standard Deviation|Mean
1248445|NCT00523341|Secondary|Bone Histomorphometry: Double-label Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The presence of double labels indicates that normal bone mineralization was actively occurring over the entire labeling interval. Double-label surface is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available double-label surface data.|||percentage of bone surface||Standard Deviation|Mean
1248446|NCT00523341|Secondary|Bone Histomorphometry: Single-label Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. A single label is deposited if formation either started or ended during the interval between the uses of the two courses of tetracycline administration. Single-label surface is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available single-label surface data.|||percentage of bone surface||Standard Deviation|Mean
1248447|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number by TRAP - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoclast number was measured using TRAP staining and is expressed per 100 mm of bone surface.~Da"|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.|||1/100 mm||Standard Deviation|Mean
1248448|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number by TRAP - Length Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoclast number was measured using TRAP staining and is expressed per mm of bone."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.|||1/mm||Standard Deviation|Mean
1248449|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoclast number was measured by quantitative histomorphometry and is expressed per 100 mm of bone surface area."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.|||1/100 mm||Standard Deviation|Mean
1248450|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number - Length Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoclast number was measured by quantitative histomorphometry and is expressed per mm of bone."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.|||1/mm||Standard Deviation|Mean
1248451|NCT00523341|Secondary|Bone Histomorphometry: Eroded Surface/Bone Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Eroded surface/bone surface is the percentage of bone surface occupied by eroded (resorption) cavities (Howships lacunae), with or without osteoclasts."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available eroded surface/bone surface data.|||percentage of bone surface||Standard Deviation|Mean
1248452|NCT00523341|Secondary|Bone Histomorphometry: Wall Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available wall thickness data.|||μm||Standard Deviation|Mean
1248453|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid thickness (width) is the mean thickness of osteoid seams on cancellous surfaces. Osteoid thickness is normally <12.5 µm. Increased osteoid thickness suggests abnormal mineralization (osteomalacia).|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid thickness data.|||μm||Standard Deviation|Mean
1248454|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Surface|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid surface is the percent of bone surface covered in osteoid.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid surface data.|||percentage of total bone surface||Standard Deviation|Mean
1248455|NCT00523341|Secondary|Bone Histomorphometry: Osteoblast - Osteoid Interface|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoblast - osteoid interface data.|||percentage of osteoid surface||Standard Deviation|Mean
1248456|NCT00523341|Secondary|Bone Histomorphometry: Surface Density|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available surface density data.|||mm²/mm³||Standard Deviation|Mean
1248785|NCT00520481|Secondary|Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks||Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only)|Zero participants were analyzed as the data were not estimable accurately due to the study sampling schedule.||||||
1248457|NCT00523341|Secondary|Bone Histomorphometry: Cancellous Bone Volume by TRAP Histomorphometry|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by tartrate-resistant acid phosphatase (TRAP) staining histomorphometry.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.|||percentage of total bone tissue volume||Standard Deviation|Mean
1248458|NCT00523341|Secondary|Bone Histomorphometry: Cortical Width|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cortical width is the average width of both inner and outer cortices.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cortical width data.|||μm||Standard Deviation|Mean
1248459|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Mean trabecular thickness is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Trabecular thickness is reduced by aging and osteoporosis.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular thickness data.|||μm||Standard Deviation|Mean
1248460|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Separation|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular separation is the mean distance between trabeculae (measured by integrated computer graphics). Trabecular separation increases with trabecular bone loss.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular separation data.|||μm||Standard Deviation|Mean
1248461|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Number|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular number is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Trabecular number is a measure of trabecular connectivity and decreases with bone loss.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular number data.|||1/mm||Standard Deviation|Mean
1248462|NCT00523341|Secondary|Bone Histomorphometry: Cancellous Bone Volume|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by quantitative histomorphometry.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.|||percentage of total bone tissue volume||Standard Deviation|Mean
1248463|NCT00523341|Secondary|Serum Denosumab Concentration|Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.8 ng/mL. Values of 0 in the table below indicate data below the lower limit of quantification.|Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose)|Participants who participated in the Study 20030216 PK substudy, for whom dosing information was not missing and for whom sampling was within 14 days of specified sampling times.|||ng/mL||Standard Deviation|Mean
1248464|NCT00523341|Secondary|Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10||Baseline (of extension study) and day 10|Participants who had a calcium corrected by albumin measurement within the Day 10 visit window up to May 31, 2008.|||percent change||Inter-Quartile Range|Median
1248465|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in P1NP by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
1248466|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in CTX-1 by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
1248467|NCT00523341|Secondary|Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new sparticipants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
1248797|NCT00520403|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.|Baseline and Cycles 3, 6, 9, 13, and 17|ITT Population; missing data were imputed using the last observation carried forward (LOCF) technique. Number (n) equals (=) number of participants assessed at each specific visit.|||percentage of participants|||Number
1248468|NCT00523341|Secondary|Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
1248469|NCT00523341|Secondary|Number of Participants With Non-Vertebral Fractures|Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|84 months|All enrolled participants|||participants|||Number
1248470|NCT00523341|Secondary|Number of Participants With New Vertebral Fractures|A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture.|84 months|All participants enrolled in the extension study who have vertebral X-ray assessment at the extension baseline and at least 1 post-extension baseline visit.|||participants|||Number
1248471|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit|1/3 radius BMD was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84|"Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
1248472|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit|Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
1248473|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
1248474|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit|Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
1248475|NCT00523341|Secondary|Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit|1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
1248476|NCT00523341|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit|Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
1248477|NCT00523341|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density by Visit|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
1248478|NCT00523341|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
1248479|NCT00523341|Primary|Number of Participants With Antibodies to Denosumab||Every 12 months through Month 84|All participants who received at least 1 dose of denosumab|||participants|||Number
1248480|NCT00523341|Primary|Number of Participants With Laboratory Toxicities of Grade ≥ 3|Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity.|84 months|All participants who received at least 1 dose of denosumab|||participants|||Number
1248819|NCT00520234|Secondary|Time to Development of Proven or Probable Invasive Candidiasis||Within 7 days after end of therapy|||||||
1248481|NCT00523341|Primary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.|84 months|All participants who received at least one dose of denosumab.|||participants|||Number
1248482|NCT00523302|Primary|THE HAMILTON DEPRESSION RATING SCALE (HRDS)|To assess each participant's level of depression, the HRDS will be administered. The HRDS is a 17-item clinician-rated scale that is designed to evaluate depressed mood, vegetative and cognitive symptoms of depression, and comorbid anxiety symptoms. Eight items are scored on a 5-point scale, ranging from 0-4, where 0=not present and 4=severe. Nine items are scored from 0-2, where 0=None, 1=Mild, and 2=Severe. The final, total score ranges from 0-52. Scores in the range of 0–7 are considered as being normal, 8–16 suggest mild depression, 17–23 moderate depression, and scores over 24 are indicative of severe depression.|Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up||||units on a scale||Standard Deviation|Mean
1248483|NCT00523302|Primary|THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified|"To assess the impact of fibromyalgia on each participant's function, the FIQ-modified (2002) version will be administered before each study visit. The FIQ-modified (2002) version assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued.~The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning."|Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up||||units on a scale||Standard Deviation|Mean
1248484|NCT00523302|Primary|Average Pain|To assess each participant's average Pain in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain in the past 24 hours using a 0–10 numerical rating scale, where 0=no pain and 10=extreme pain.|Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up||||units on a scale||Standard Deviation|Mean
1248485|NCT00523237|Primary|The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir|evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir|24 weeks|With expected man baseline residual viremia of 5 copies/ml and predicted standard deviation of 3 in change of residual viremia, our study was predicted to have 80% power to detect a difference of 2.5 copies/ml in residual viremia with =0.05.|||percentage|||Number
1248486|NCT00522951|Secondary|Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions|ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||ICC|||Number
1248487|NCT00522951|Secondary|Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist|CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||CNR||Standard Deviation|Mean
1248488|NCT00522951|Secondary|Lesion Size Evaluated by Independent Radiologist|Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||mm||Standard Deviation|Mean
1248489|NCT00522951|Secondary|Number of Participants With Reasons for Performance in SRS Planning by Investigator|Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure|||participants|||Number
1248490|NCT00522951|Secondary|Number of Participants With Reasons for Performance in SRS Planning by TPE|Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure|||participants|||Number
1248491|NCT00522951|Secondary|Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator|Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure|||participants|||Number
1248820|NCT00520234|Secondary|Initiation of Other Antifungals||Within 7 days after end of therapy|||||||
1248821|NCT00520234|Secondary|All Cause Mortality||Within 7 days of end of therapy|||||||
1248492|NCT00522951|Secondary|Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE|Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure|||participants|||Number
1248493|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||participants|||Number
1248494|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||participants|||Number
1248495|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||participants|||Number
1248496|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)|Treatment planning confidence evaluated separately for each image set (gadobutrol [Gado-] 0.1 mmol/kg bw and gadoteridol [Pro-] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||participants|||Number
1248497|NCT00522951|Secondary|Score of Visibility Assessment - Border Delineation by Investigator|Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||scores on a scale||Standard Deviation|Mean
1248498|NCT00522951|Secondary|Score of Visibility Assessment - Border Delineation by Blinded Reader|Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||scores on a scale||Standard Deviation|Mean
1248499|NCT00522951|Secondary|Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator|Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||scores on a scale||Standard Deviation|Mean
1248500|NCT00522951|Secondary|Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader|Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||scores on a scale||Standard Deviation|Mean
1248501|NCT00522951|Primary|Number of Lesions Detected by Blinded Readers (BR) and Investigator|Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||lesions||Standard Deviation|Mean
1248502|NCT00522925|Secondary|Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure||4 weeks of treatment with PS43540|||||||
1248503|NCT00522925|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure||4 weeks of treatment with PS43540|||||||
1248504|NCT00522925|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure||4 weeks of treatment with PS43540||||mmHg||95% Confidence Interval|Mean
1248505|NCT00522873|Secondary|Number of Participants With Amenorrhea During Month 10 to 12 of Treatment|The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.|Month 10 to Month 12|Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations|||Participants|||Number
1248506|NCT00522873|Secondary|Number of Participants With Amenorrhea During Month 1 to 3 of Treatment|The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.|Month 1 to Month 3|Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations|||Participants|||Number
1248576|NCT00522275|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)|Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
1248822|NCT00520234|Secondary|Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.||Within 7 days of end of therapy|||||||
1248507|NCT00522873|Primary|Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)|The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.|Up to one year|For the DRSP/E2 group only - Primary analysis set (PAS): All subjects from the full analysis set (FAS) who either had a biopsy result classified as ‘normal’ or ‘hyperplasia or worse’ after a year of treatment or who prematurely discontinued the study before Cycle 13 with a biopsy classified as ‘hyperplasia or worse’.|||Participants|||Number
1248508|NCT00522795|Primary|Complete Pathologic Response|Per pathology review post surgery|At Surgery approximately 4weeks after last treatment|Twelve of 37 patients (32%) had pathologic complete responses. The 12 patients with pathologic CR all had adenocarcinoma.|||participants|||Number
1248509|NCT00522626|Secondary|Maternal Physiologic Parameters||120 minutes|||||||
1248510|NCT00522626|Primary|Fetal Heart Rate|Fetal heart rate in beats per minute|60 minutes|Total number of subjects completing assessment|||beats per minute||Standard Deviation|Mean
1248511|NCT00522548|Secondary|Pharmacokinetics (Mycophenolic Acid Area Under the Curve) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients|Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose). A mycophenolic acid area under the curve value, also known as AUC represents drug exposure.|1 and 6 months|Any participant who completed at least one pharmacokinetic studies was included in this pharmacokinetic analyses.|||mg*hr/L||Standard Deviation|Mean
1248512|NCT00522548|Secondary|Pharmacokinetics (Mycophenolic Acid Maximum Concentration) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients|Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).A mycophenolic acid drawn at the peak level is called C Max or maximum concentration.|1 and 6 months|Any participant who completed at least one pharmacokinetic studies was included in this pharmacokinetic analyses.|||mg/L||Standard Deviation|Mean
1248513|NCT00522548|Secondary|Pharmacokinetics (Mycophenolic Acid Trough Levels) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients|Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of enteric coated mycophenolate sodium and mycophenolate mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).|1 and 6 months|Any participant who completed at least one pharmacokinetic studies was included in this analysis.|||mg/L||Standard Deviation|Mean
1248514|NCT00522548|Secondary|Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates were used as part of a measure of renal function and measured at 24 weeks in patients who were still participating in the study at that point.|6 months|Any patient with Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates at 24 weeks was included in the analysis|||MDRD (mL/min/1.73m2)||Standard Deviation|Mean
1248515|NCT00522548|Secondary|Serum Creatinine in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|Serum creatinine lab values were used as part of a measure of renal function at 24 weeks for any patient that was still participating in the study at this time-point.|6 months|Any patient with serum creatinine values available at 24 weeks|||serum creatinine mg/dL||Standard Deviation|Mean
1248516|NCT00522548|Secondary|The Incidence of Rejection in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz.|All rejection episodes of the kidney transplant were proven by kidney transplant biopsy and were measured at 24 weeks for all patients still participating in the study at that timepoint.|6 months|Included any patient who experienced rejection while enrolled in the study up to 6 months post-transplant.|||participants|||Number
1248517|NCT00522548|Secondary|The Incidence of the Occurrence of Lower Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant. Patients who withdrew from the study only had data included up to the point of withdraw. No values were carried forward.|6 months|Any patient with a mean GSRS subscale score > 1 on dimensions constipation or diarrhea were considered to have lower GI symptoms.|||Participants|||Count of Participants
1249329|NCT00517413|Secondary|Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase|Red blood cell (RBC) transfusions were permitted during the treatment period in case of medical need. The pre-transfusion Hb level was measured before any transfusion was administered.|Baseline (Week 0) to Week 44|The safety population included all participants who entered into the study.|||participants|||Number
1248518|NCT00522548|Secondary|The Incidence of the Occurrence of Upper Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant.|6 months|Any patient with mean GSRS subscale score >1 from dimensions: abdominal pain, indigestion, or reflux were considered to have upper GI symptoms.|||Participants|||Count of Participants
1248519|NCT00522548|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Score Changes From Baseline to 24 Weeks After Transplant in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, indigestion, constipation, abdominal pain, and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 after transplant.|baseline (pre-transplant to two days after transplant) and at 6 months after transplant.|Patients who withdrew from the study before 24 weeks were excluded from this analysis.|||Participants|||Count of Participants
1248520|NCT00522548|Secondary|The Incidence of Intolerance (Defined as Transient Dose Reduction or Transient Discontinuation of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|The incidence of intolerance was defined as transient dose reduction or transient discontinuation of enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent manufactured by Sandoz meaning doses could subsequently be resumed or increased back to original starting dose, once intolerance resolved.|6 months|Based on number of patients participating in the study at 6 months|||participants|||Number
1248521|NCT00522548|Secondary|The Incidence of the Requirement of Full Dose Proton Pump Inhibitors in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|If patients were not on any medications from a medication class known as H-2 antagonists, they were started on ranitidine 150 mg orally twice daily after transplant (with dose adjusted for renal function). Patients were excluded if they were on proton pump inhibitor at time of study screening, however some patients required addition of proton pump inhibitor post-study enrollment. If a patient had upper gastrointestinal side effects such as acid reflux unreleived on ranitidine therapy or nausea, they were switched to a proton pump inhibitor.|6 months|Based on number of patients participating in study at 6 months|||participants|||Number
1248522|NCT00522548|Primary|Gastrointestinal Toxicity Due to Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz|At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.|6 months|Based on the number of patients who were participating in the trial at that timepoint and had not withdrawn at 24 weeks|||participants|||Number
1248523|NCT00522457|Secondary|Clinical Benefit Rate|The study was prematurely terminated, therefore no participants were analyzed|patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed|||participants|||Number
1248524|NCT00522457|Secondary|Duration of Response|The study was prematurely terminated, therefore no participants were analyzed|patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed|||participants|||Number
1248525|NCT00522457|Primary|Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)||patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed. The primary endpoint was the objective response rate (ORR) to ertumaxomab (best response during the course of the study), defined as the number of patients with CR or PR according to RECIST, relative to the total population of treated patients|||participants|||Number
1248526|NCT00522431|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90|Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL|0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90|Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis|||percentage of participants|||Number
1248527|NCT00522431|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90|Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL|0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90|Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis|||percentage of participants||95% Confidence Interval|Number
1248577|NCT00522275|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
1248528|NCT00522418|Secondary|Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures|The Clinical Global Impression scale (CGI-I)is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248529|NCT00522418|Secondary|Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40|QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Change from baseline up to 12 months|This outcome measure includes patients from both arms VNS + BMP (N=17) and BMP alone (N=17), with an overall QOLIE-89 at baseline and any other baseline visit up to 12 months. Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40|||units on a scale||Standard Error|Least Squares Mean
1248530|NCT00522418|Secondary|Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40|QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Change from baseline up to 12 months|This outcome measure includes patients from both arms, VNS + BMP (N=30) and BMP alone (N=31), with an overall QOLIE-89 at baseline and any other post baseline visit up to 12 months. Subgroup Analysis of population with Baseline Adverse Event Profile Score >= 40|||Units on a Scale||Standard Error|Least Squares Mean
1248531|NCT00522418|Secondary|Percent of Participants Who Were Compliant With the Protocol|Retention rate in patients with less then a 50% reduction in seizures|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248532|NCT00522418|Secondary|Change in the Number of Anti-epileptic Drugs Prescribed|Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248533|NCT00522418|Secondary|Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures|Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248534|NCT00522418|Secondary|Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures|The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248535|NCT00522418|Secondary|Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction|The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248536|NCT00522418|Secondary|Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures|QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248537|NCT00522418|Secondary|Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal|Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248538|NCT00522418|Secondary|Retention Rate|Percent of participants who were compliant with the protocol.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248540|NCT00522418|Secondary|Change From Baseline in Adverse Event Profile (AEP) Score|Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Mean change from baseline AEP Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Units on a scale||Standard Deviation|Mean
1248541|NCT00522418|Secondary|Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months|The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Mean change from baseline CGI-I Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Units on a Scale||Standard Deviation|Mean
1248542|NCT00522418|Secondary|Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score|The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.|Mean change from baseline NDDI-E Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Units on a Scale||Standard Deviation|Mean
1248543|NCT00522418|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score|The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.|Mean change from baseline CES-D Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Units on a Scale||Standard Deviation|Mean
1248544|NCT00522418|Secondary|Seizure Free Days Over the Last 6 Months||Over the last 6 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248545|NCT00522418|Secondary|Seizure Free Days|Seizure free days is defined as the time from last seizure to study exit date.|From the patient's last seizure to the study exit date|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248546|NCT00522418|Secondary|Mean Percent Change in Seizure Frequency|Percent change in total seizuires per week from baseline at 12 months|Mean percent change from baseline in seizure frequency at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Percent Change||Standard Deviation|Mean
1248547|NCT00522418|Secondary|Percent of Patients That Are Seizure Free|Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.|3, 6, 9, 12, 15, 18, 21, 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
1248548|NCT00522418|Secondary|Response Rate|Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.|Number of Responders at 12 Months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||participants|||Number
1248549|NCT00522418|Primary|Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment|QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.|Mean change from baseline QOLIE-89 Overall Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||units on a scale||Standard Deviation|Mean
1248578|NCT00522275|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
1248550|NCT00522392|Secondary|Change in Quality of Life (QOL) From Baseline to 6 Months Post Consolidation as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI)|The combined score on the FACT-Ntx TOI is of interest. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible quality of life) -100 (best possible quality of life). The primary QOL endpoint is defined as the change in the FACT-Ntx TOI score from registration to 6 months post consolidation treatment.|Baseline and 6 months post consolidation treatment|Patients with both assessments complete at baseline and 6 months post consolidation treatment were included in this analysis.|||units on a scale||Full Range|Mean
1248551|NCT00522392|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date of last known alive. The OS results are based on data as of April 2014.|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|All randomized patients|||Months||95% Confidence Interval|Median
1248552|NCT00522392|Secondary|Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])|"CR:~Patients with complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. To be considered CR, patients must meet all of the following criteria:~Negative immunofixation on the serum and urine at two consecutive times~Disappearance of any soft tissue plasmacytomas~≤5% plasma cells in bone marrow~If serum and urine M protein are unmeasurable and the immunoglobulin free light chain (FLC) parameter is being used, patients must have a normal ratio of 0.26-1.65 at two consecutive times~VGPR:~Serum and urine M-component detectable by immunofixation but not on electrophoresis OR~>=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP)~If the serum and urine M protein are unmeasurable and the immunoglobulin FLC parameter is being used, a >90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M protein criteria"|Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|Patients with measurable disease at randomization were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1248553|NCT00522392|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment.~The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued."|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|All randomized patients|||Months||95% Confidence Interval|Median
1248554|NCT00522379|Secondary|"The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis. The Observed Cases (OC) method was utilized.|||Hours||Standard Deviation|Mean
1248555|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?|"Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
1248556|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?|"Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
1248557|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?|"Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
1248579|NCT00522171|Secondary|Total Number of Hours From Drain Placement to Drain Removal|Total number of hours from drain placement to drain removal|From drain placement to drain removal (</= 770 hours)|terminated study|||hours||Standard Deviation|Mean
1248558|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average?"|"Item = What proportion of the waking day is the subject “off”, on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 – 4 points (4 = maximum). A higher score indicates the subject is “off” a larger portion of the waking day.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
1248559|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly?"|"Item = Do “off” periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods come on suddenly, within a few seconds.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
1248560|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable?"|"Item = Are “off” periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods are unpredictable.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
1248561|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable?"|"Item = Are “off” periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods are predictable.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
1248562|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia|"Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
1248563|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?|"Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||participants|||Number
1248564|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?|"Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||participants|||Number
1248580|NCT00522171|Primary|Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal|Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure|From the time of drain placement to time of drain removal (</= 770 hours)|ITT|||milliliter||Standard Deviation|Mean
1249341|NCT00517296|Secondary|Changes in Perianal Disease Activity Index (PDAI)|Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.|Baseline and 48 Weeks||||units on a scale||Inter-Quartile Range|Mean
1248565|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?|"Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||participants|||Number
1248566|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change score indicates improvement.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 496 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||units on a scale||Standard Deviation|Mean
1248567|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period|The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 497 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||units on a scale||Standard Deviation|Mean
1248568|NCT00522379|Secondary|The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary||From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis.|||Hours||Standard Deviation|Mean
1248569|NCT00522379|Secondary|"The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “On” is defined as when the patient has the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||Hours||Standard Deviation|Mean
1248570|NCT00522379|Secondary|"The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “On” is defined as when the patient has the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward method was utilized.|||Hours||Standard Deviation|Mean
1248571|NCT00522379|Secondary|"The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||Hours||Standard Deviation|Mean
1248572|NCT00522379|Primary|"The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||Hours||Standard Deviation|Mean
1248573|NCT00522301|Primary|Progression-free Survival (PFS) Rate at 12 Months|All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met.|1 year|Protocol terminated prior to primary outcome evaluation. All 5 patient were evaluable for toxicity only.||||||
1248574|NCT00522275|Secondary|Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.|Treatment Period (Maximum 6 years)|Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.|||percentage of subjects|||Number
1248575|NCT00522275|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)|Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.|Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)|Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.|||percentage change||Full Range|Median
1249342|NCT00517296|Secondary|Changes in Disease Activity|Changes in Crohn's disease activity using the Harvey Bradshaw Index (HBI) at Week 48 compared to baseline HBI Scores. Higher numbers for the HBI equal more significant disease activity. Range can vary from 0 to 17 plus the number of liquid stools per day.|Baseline and 48 Weeks||||units on a scale||Inter-Quartile Range|Mean
1248581|NCT00522041|Secondary|Percentage of Responders|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A responder was defined as a participant with either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in the 24 hour average pain intensity averaged over Days 14 to 18.|Baseline to Day 18|Intent-to-treat population: All randomized participants who had applied the study medication at least once.|||Percentage of responders|||Number
1248582|NCT00522041|Secondary|Time to an Improvement in Pain Intensity|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale (VAS) at Baseline and on each of the 21 treatment days of the study. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. Improvement was defined as either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in rated pain intensity.|Baseline to Day 21|Intent-to-treat population: All randomized participants who had applied the study medication at least once. Only participants with an improvement in pain intensity were included in the analysis.|||Days||Standard Error|Mean
1248583|NCT00522041|Primary|Change From Baseline in Pain Intensity at Days 14-18|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement.|Baseline to Day 18|Intent-to-treat population: All randomized participants who had applied the study medication at least once.|||Units on a scale||Standard Error|Mean
1248584|NCT00521989|Secondary|To Assess the Efficacy of the CRx-102 Compared to Placebo on the Change From Baseline to Day 98 Using the Full WOMAC Pain, Stiffness, Physical Function Parameters, and Patient Global Assessment VAS.||Day 98|||||||
1248585|NCT00521989|Primary|Change From Baseline to Day 98 Using the WOMAC Pain Question #1|"The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface. This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with No Pain on the left (0 mm) and Extreme Pain on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome."|Baseline to Day 98|ITT population|||millimeters||Standard Deviation|Mean
1248586|NCT00521976|Secondary|Recurrent Troponin-T (TnT) Positive Events|Recurrent Troponin-T (TnT) positive events; Symptoms of coronary ischemia associated with TnT >0.05 ng/mL with a pattern of gradual rise and fall in TnT|24 months.||||Participants|||Number
1248587|NCT00521976|Primary|Total Mortality.||24 months.||||Participants.|||Number
1248588|NCT00521924|Secondary|DAS 28 at Baseline vs at Week 38; Quality of Life; American College of Rheumatology (ACR) Response Disease Progression (X-ray); Effect of Inflammatory Markers on Response and Disease Progression; Assess Simplified Disease Activity Index (SDAI).|These were not prespecified key secondary outcomes; therefore, results will not be disclosed.|Weeks 14, 38, and 62|||||||
1248589|NCT00521924|Primary|Number of Patients in Remission According to Disease Activity Score (DAS) 28 (< 2.6)|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Patients can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|after 38 weeks|This trial terminated early due to poor enrollment. Since none of the randomized patients reached Week 38, no change of DAS28 between baseline and Week 38 could be analyzed.||||||
1248590|NCT00521885|Secondary|Deep Vein Thrombosis|Confirmed by Lower Extremity Ultra-sonogram|14 Days|||||||
1248591|NCT00521885|Primary|Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u|Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding.|14 days|||||||
1248592|NCT00521599|Primary|Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.|Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.|Baseline and Week 8 End|All treated subjects included all but one placebo-treated subject from the All Randomized Subjects data set, who was randomized, but never treated in either the open-label or double-blind Treatment Periods due to non-compliance with the protocol|||liters/minute||Standard Deviation|Least Squares Mean
1248593|NCT00521586|Other Pre-specified|Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-serious AEs are AEs excluding SAEs. In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.|Signing of informed consent up to 194 days after re-vaccination at Year 5|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.|||percentage of participants|||Number
1248857|NCT00519779|Secondary|ln(CES-D)|"log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score~The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||scores on a||Standard Error|Least Squares Mean
1248594|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).|Within 30 Minutes After 13vPnC (Year 5)|Safety population at Year 5 included all participants who had received at least 1 vaccination and did not lack any safety data.|||percentage of participants|||Number
1248595|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 30 Minutes After Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination (Dose 2, year 0) and did not lack any safety data.|||percentage of participants|||Number
1248596|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 30 Minutes After Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data.|||percentage of participants|||Number
1248597|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)|Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after 13vPnC (Year 5)|The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.|||percentage of participants|||Number
1248598|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)|Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.|||percentage of participants|||Number
1248599|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)|Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.|||percentage of participants|||Number
1248600|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).|Within 14 days after 13vPnC (Year 5)|The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.|||percentage of participants|||Number
1248601|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 14 days after Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here,n=number of participants with known values.|||percentage of participants|||Number
1249343|NCT00517296|Primary|Number of Participants With Durable Fistula Healing|Complete cessation of fistula drainage at 48 weeks|at week 48||||participants|||Number
1248602|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 14 days after Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.|||percentage of participants|||Number
1248603|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.|Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and the specified timepoints.|||fold-rises||95% Confidence Interval|Geometric Mean
1248604|NCT00521586|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV). Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.|Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Years 0 through Year 5 within the protocol specified time window. Here, n=number of participants with valid and determinate assay results for the specified serotype at the given time points.|||mcg/mL||95% Confidence Interval|Geometric Mean
1248605|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
1248606|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.|before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
1248631|NCT00521365|Secondary|Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|"Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF).~SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18."|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
1249344|NCT00517192|Secondary|Occurrence of New AIDS Progression Events or Death||through 48 weeks of treatment|||||||
1249345|NCT00517192|Secondary|Change From Baseline in log10 Viral Load up to Week 48||up to week 48|||||||
1248607|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
1248608|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
1248609|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
1248610|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both Year 5 time points.|before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
1248611|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 1 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.|||microgram per milliliter(mcg/mL)||95% Confidence Interval|Geometric Mean
1248612|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.|Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and all the specified timepoints.|||fold-rises||95% Confidence Interval|Geometric Mean
1248682|NCT00521339|Secondary|Apparent Total Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) During the Treatment Phase|"Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) (for Days 1, 85, and 169/170)~For Day 1, Vz/F was not calculated.~For Days 85 and 169/170, apparent volume of distribution of drug (V/z) based on the terminal phase was calculated as follows: Vz/F=Dose/(λ*AUC^12)"|Day 85|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||mL||Geometric Coefficient of Variation|Geometric Mean
1248613|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. n=participants with valid and determinate assay results for the specified serotype at before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.|Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window.|||titers||95% Confidence Interval|Geometric Mean
1248614|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
1248615|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.|before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||titers||95% Confidence Interval|Geometric Mean
1248616|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both 1 month after 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
1248617|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 0 and 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.|||titers||95% Confidence Interval|Geometric Mean
1248618|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.|||fold-rises||95% Confidence Interval|Geometric Mean
1248619|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants with immunogenicity data at both Year 5 endpoints.|before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5.n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws for each treatment arm, respectively.|||titers||95% Confidence Interval|Geometric Mean
1248620|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 Month After 13vPnC (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC (Year 5)|All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.|||titers||95% Confidence Interval|Geometric Mean
1248621|NCT00521586|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose at year 0|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation. n=participants with valid and determinate assay results for the specified serotype at the given visit.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1248622|NCT00521586|Primary|Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1|Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV – Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.|1 month after Dose 1|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation.|||percentage of participants||95% Confidence Interval|Number
1248623|NCT00521456|Post-Hoc|Visual Acuity|Patients with ≥ 3 line improvement in visual acuity|Change from baseline at Day 14|Modified Intent-to-Treat Population|||Percentage of patients with ≥ 3 lines|||Number
1248624|NCT00521456|Secondary|Mean Pupil Area|Pupil area post-irrigation and aspiration|Day 0|Modified Intent-to-Treat Population|||millimeters squared (mm²)||Standard Deviation|Mean
1248625|NCT00521456|Secondary|Ocular Pain|Measured on a scale of 0-4 (0 = none, 4 = intolerable)|Day 1|Modified Intent-to-Treat Population|||% of participants with a score of 0|||Number
1248626|NCT00521456|Primary|Resolution of Post Operative Inflammation|Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)|Day 14|Modified Intent-to-Treat Population|||% of participants with a score of 0|||Number
1248627|NCT00521365|Secondary|Number of Participants With >7% Increase in Weight|Number of participants with >7% increase in weight from baseline to end of study.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Participants|||Number
1248628|NCT00521365|Secondary|Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).||Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||cm||Standard Deviation|Mean
1248629|NCT00521365|Secondary|Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).||Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Kg||Standard Deviation|Mean
1248630|NCT00521365|Secondary|Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
1249346|NCT00517192|Secondary|Change From Baseline in CD4+ Cell Count up to Week 48||up to week 48|||||||
1248632|NCT00521365|Secondary|Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
1248633|NCT00521365|Secondary|Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.|Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life).|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
1248634|NCT00521365|Secondary|Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).|Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
1248635|NCT00521365|Secondary|Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).|Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
1248636|NCT00521365|Secondary|Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).|"Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11.~YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60."|21 days ± 2 days or Last Observation Carried Forward||||Participants|||Number
1248637|NCT00521365|Secondary|Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)|"Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score.~YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60."|21 days ± 2 days or Last Observation Carried Forward||||Participants|||Number
1248638|NCT00521365|Secondary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3|Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.|Baseline and 2 weeks|Outcome was comparing the data at baseline with the specific data at visit 3 (not with the LOCF), since only 79 patients completed YMRS at visit 3 the number of patients analyzed is different respect to the LOCF (88).|||Scores on a scale||Standard Deviation|Mean
1248639|NCT00521365|Secondary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.|Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.|Baseline and 1 week|Outcome was comparing the data at baseline with the specific data at visit 2(not with the LOCF), since only 78 patients completed YMRS at visit 2 the number of patients analyzed is different respect to the LOCF (88).|||Scores on a scale||Standard Deviation|Mean
1248640|NCT00521365|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)|Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.|Baseline and 3 weeks|Modified Intention to treat patients (88). Patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
1248641|NCT00521352|Secondary|Clinical Improvement (CGI-S)|"Minimum CGI-S score: 1 Maximum CGI-S score: 7~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.~Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.~= Normal, not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients"|4 weeks||||responders (CGI-S = 1 or 2)|||Number
1248642|NCT00521352|Primary|Hamilton Depression Rating Scale (HDRS), 28 Item Version|"The Hamilton Rating Scale for Depression (HRSD) is a multiple item questionnaire used to provide an indication of depression severity. The 28-, rather then 17- or 24-, item version was used to assess subjects in this protocol.~28-item minimum score = 0 28-item maximum score = 84~Higher scores indicate high levels of symptomatology. Reduction in score from baseline indicates clinical symptom improvement."|4 weeks||||responders|||Number
1248858|NCT00519779|Primary|Stimulated ln(TNF-alpha)|log-transformed stimulated TNF-alpha|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||ln(pg/mL)||Standard Error|Least Squares Mean
1248643|NCT00521352|Primary|Panic Disorder Severity Scale (PDSS)|"The Panic Disorder Severity Scale is a questionnaire developed for measuring the severity of panic disorder symptoms.~The PDSS consists of seven items, each rated on a 5-point scale, which ranges from 0 to 4. The items assess panic frequency, resulting distress, panic-focused anticipatory anxiety, phobic avoidance of situations and of physical sensations, impairment in occupational and social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. The total scores range from 0 to 28.~Higher scores indicate high levels of panic symptomatology. Reduction in score from baseline indicates clinical improvement of panic symptoms."|4 weeks||||responders|||Number
1248644|NCT00521339|Secondary|Mean Residence Time (MRT) During the Extension Phase|Mean Residence Time (MRT) is defined as the mean duration of time the drug spends in the body. The average concentration at steady state (Cavg) (for Days169/170) was calculated as follows: Cavg = (Day 169/170)/(12)|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||hours||Geometric Coefficient of Variation|Geometric Mean
1248645|NCT00521339|Secondary|Accumulation Index During the Extension Phase|Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Not able to calculate the Accumulation Index at this time point; insufficient data collection for this calculation.||||||
1248646|NCT00521339|Secondary|Apparent Total Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) During the Extension Phase|For Days 169/170, apparent volume of distribution of drug (V/z) based on the terminal phase was calculated as follows: Vz/F=Dose/(λ*AUC12) where λ = the terminal elimination rate constant|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||mL||Geometric Coefficient of Variation|Geometric Mean
1248647|NCT00521339|Secondary|Apparent Total Clearance of Apremilast From Plasma After Extravascular Administration (CL/F) During the Extension Phase|For 169/170, apparent clearance of drug from plasma after extravascular administration (CL/F) was calculated as follows: CL/F= Dose/AUC12|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast. This analysis was performed for participants with normal renal function only.|||mL/hour||Geometric Coefficient of Variation|Geometric Mean
1248648|NCT00521339|Secondary|Terminal Phase Elimination Half Life of Apremilast (t½) During the Extension Phase|Terminal phase elimination half-life (t1/2) was calculated as follows: t1/2 = 0.693/λz. The terminal elimination rate constant (λZ) was estimated by linear regression of the log-transformed concentration-time data.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||hours||Geometric Coefficient of Variation|Geometric Mean
1248649|NCT00521339|Secondary|Time to Maximum Plasma Concentration (Tmax) During the Extension Phase|The time to reach Cmax (Tmax) was obtained directly from the observed concentration-time data on Day 169/170. Actual times utilized were used for reporting Tmax values.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||hours||Geometric Coefficient of Variation|Geometric Mean
1248650|NCT00521339|Secondary|Peak (Maximum) Plasma Concentration of Apremilast (Cmax) During the Extension Phase|The maximum observed plasma concentration of CC-10004 (Cmax); the maximum plasma concentration (Cmax) was obtained directly from the observed concentration-time data on Days 169/170.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1248651|NCT00521339|Secondary|Area Under the Plasma Concentration Time-curve From 0 to 12 Hours Post Dose (AUC 0-12) During the Extension Phase|Plasma concentrations of apremilast were determined using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS).|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1248652|NCT00521339|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item Health Survey (SF-36) Scores, Mental and Physical Components to Week 12|The SF-36 was a self-administered instrument consisting of 8 multi-item scales that assess 8 health domains: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. A higher score post-baseline is indicative of improvement in the disease state. The summary physical health score included physical functioning, role-physical, bodily pain and general health. The summary mental health score included: vitality, social functioning, role-emotional and mental health. The resulting score for each subscale is then standardized, to obtain values ranging from 0 to 100, with higher values indicating a better QOL.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.|||units on a scale||Standard Deviation|Mean
1248653|NCT00521339|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 12|DLQI was the dermatology-specific quality of life (QOL) measure used for the psoriatic population. The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on a participants QoL, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Possible responses for each of the 10 items are: not at all, a little, a lot, and very much. Each question is rated on a scale of 0 to 3 with a total range of 0 to 30. Higher scores indicate greater impact of disease on QOL|Baseline to Week 12|Only those with both a baseline and final/termination visit assessment were included in the analyses of change from baseline. Safety population consisted of all participants who were enrolled and received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
1248654|NCT00521339|Secondary|Percent Change From Baseline in the Dendritic Cell (CD83) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248655|NCT00521339|Secondary|Percent Change From Baseline in the IL2 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248656|NCT00521339|Secondary|Percent Change From Baseline in the Chemokine Ligand (CXCL9) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248657|NCT00521339|Secondary|Percent Change From Baseline in the IL10 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248658|NCT00521339|Secondary|Percent Change From Baseline in the Interferon (INF) Gamma Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248659|NCT00521339|Secondary|Percent Change From Baseline in the Tumor Necrosing Factor (TNF) Alpha Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Week 0 to Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248660|NCT00521339|Secondary|Percent Change From Baseline in the IL17A Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248661|NCT00521339|Secondary|Percent Change From Baseline in the MX1 (Gene That Encodes the Interferon-induced p78 Protein) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248662|NCT00521339|Secondary|Percent Change From Baseline in the IL8 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248663|NCT00521339|Secondary|Percent Change From Baseline in the pluripotent19 (P19) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1249347|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 48||up to week 48|||||||
1248664|NCT00521339|Secondary|Percent Change From Baseline in the keratin16 (K16) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248665|NCT00521339|Secondary|Percent Change From Baseline in the Defensin Beta 4 (DEFB4) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) i being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248666|NCT00521339|Primary|Treatment Emergent Adverse Events (TEAEs) During the Extension Phase|"TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.~Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event."|Week 12 to Week 24|Safety population consisted of all participants who were enrolled and received at least one dose of study medication in treatment Extension Phase.|||participants|||Number
1248667|NCT00521339|Secondary|Percent Change From Baseline in the p40 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248668|NCT00521339|Secondary|Percent Change From Baseline in the Interleukin (IL) IL-22 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248669|NCT00521339|Secondary|Percent Change From Baseline in the Inducible Nitric Oxide (iNOS) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248670|NCT00521339|Secondary|Percent Change From Baseline of Epidermal Thickness in the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248671|NCT00521339|Secondary|Percent Change From Baseline of Langerin in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248672|NCT00521339|Secondary|Percent Change From Baseline of Langerin in the Dermis of Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1249348|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 24||up to week 24|||||||
1249349|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 8||up to week 8|||||||
1248673|NCT00521339|Secondary|Percent Change From Baseline of CD56 in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248674|NCT00521339|Secondary|Percent Change From Baseline of CD56 in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248675|NCT00521339|Secondary|Percent Change From Baseline of CD11c in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248676|NCT00521339|Secondary|Percent Change From Baseline of CD 11c in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248677|NCT00521339|Secondary|Percent Change From Baseline of CD3 in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248678|NCT00521339|Secondary|Percent Change From Baseline of CD3 in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
1248679|NCT00521339|Secondary|Change From Baseline in Peripheral Blood T Cell, B Cell, and NK Cell Subsets at Week 12|T cells or T lymphocytes, a type of white blood cell, play a role in cell-mediated immunity. T cells are distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on the cell surface and mature in the thymus. B cells, a type of lymphocyte in the humoral immunity of the adaptive immune system can be distinguished by the presence of a protein on the B cells outer surface called a B cell receptor (BCR). This receptor protein allows a B cell to bind to a specific antigen and make antibodies against antigens [(antigen-presenting cells APCs)], and to develop into memory B cells after activation by antigen interaction. Natural Killer Cells (NK) are a type of cytotoxic lymphocyte critical to the innate immune system. Their role is analogous to that of cytotoxic T cells in the vertebrate adaptive immune response. They constitute the third kind of cells differentiated from the common lymphoid progenitor generating B and T lymphocytes and mature in the bone marrow.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the peripheral blood T cell, B cell and NK cell subsets at Baseline and Week 12.|||percentage of lymphocytes||Standard Deviation|Mean
1248680|NCT00521339|Secondary|Mean Residence Time (MRT) During the Treatment Phase|Mean Residence Time (MRT) is defined as the mean duration of time the drug spends in the body. The average concentration at steady state (Cavg) (for Day 85 was calculated as follows: Cavg = (Day 85 AUC0-12)/(12).|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast|||hours||Geometric Coefficient of Variation|Geometric Mean
1248681|NCT00521339|Secondary|Accumulation Index (R)|Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1248724|NCT00520975|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. Kaplan-Meier method was used to estimate the median OS.|assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years|All randomized patients|||Months||95% Confidence Interval|Median
1248683|NCT00521339|Secondary|Apparent Total Clearance of Apremilast From Plasma After Extravascular Administration (CLz/F) During the Treatment Phase|"The apparent total clearance of apremilast from plasma after extravascular administration (CLz/F); for Day 1, apparent clearance of drug from plasma (CL/F) was not calculated.~For Day 85, Apparent clearance of drug from plasma after extravascular administration (CL/F) was calculated as follows: CL/F= Dose/AUC^12 where τ=12."|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast. This analysis was performed for participants with normal renal function only.|||mL/hour||Geometric Coefficient of Variation|Geometric Mean
1248684|NCT00521339|Secondary|Terminal Phase Elimination Half Life of Apremilast (t½)|Terminal phase elimination half-life (t1/2) was calculated as follows: t1/2 = 0.693/λz. The terminal elimination rate constant (λZ) was estimated by linear regression of the log-transformed concentration-time data.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1248685|NCT00521339|Secondary|Time to Maximum Plasma Concentration (Tmax) During the Treatment Phase|The time to reach Cmax (Tmax) was obtained directly from the observed concentration-time data on Day 85. Actual times utilized were used for reporting Tmax values.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||hours||Full Range|Median
1248686|NCT00521339|Secondary|Trough Plasma Concentration (Cmin)|The trough observed plasma concentration of apremilast (Cmin) was determined directly from the observed pre-AM dose concentration on Day 85.|Day 85 Pre-dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1248687|NCT00521339|Secondary|Peak (Maximum) Plasma Concentration of Medication (Cmax)|The maximum observed plasma concentration of apremilast (Cmax); the maximum plasma concentration (Cmax) was obtained directly from the observed concentration-time data on Days 1, 85, and 169/170, respectively.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1248688|NCT00521339|Secondary|Area Under the Plasma Concentration Time-curve From 0 to 12 Hours Post Dose (AUC 0-12)|Plasma concentrations of apremilast were determined using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). For Day 1, AUC0-12 was calculated, using linear trapezoidal area method in WinNonlin (linear-linear trapezoidal). For Days 85 and 169/170, the AUC during a dosing interval (12 hours) (AUC0-12), was calculated at steady-state using the partial area function within WinNonlin.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1248689|NCT00521339|Secondary|Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase|"A relapse was defined as a 50% loss of maximal American College of Rheumatoid (ACR) Score improvement in participants with psoriatic arthritis who achieved at least an ACR 20 score during the treatment phase.~Relapses were only captured prior to the prescription of concomitant psoriatic treatment."|Observational follow up phase; Days 168 to Day 196|This endpoint was not summarized since there were only 8 participants with psoriatic arthritis enrolled in the study and only 2 participants who achieved an ACR 20 response during the treatment phase.||||||
1248690|NCT00521339|Secondary|Percent of Participants With Psoriatic Arthritis Who Achieved an American College of Rheumatology 20% Improvement (ACR-20) Response at Week 12|"A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. Last observation carried forward was used. Only a small percentage of participants had psoriatic arthritis.|||percentage of participants|||Number
1248691|NCT00521339|Secondary|Time to Relapse of Psoriasis (50% Loss of Maximal PASI Score Improvement in Participants Who Achieved at Least PASI-50 During the Treatment Phase) During the Observational Follow up Phase|Time to relapse of psoriasis (50% loss of maximal PASI score improvement in participants who achieved at least PASI-50 during the treatment phase) during the observational follow up phase was not analyzed. Time to relapse of psoriasis was defined as a 50% loss of maximal PASI score improvement in participants who achieved at least PASI-50 during the treatment or extension phase. The lesion on each area of the body was assessed for redness, thickness, and scaling.|28-day Observational Follow-up Phase; Days 168 to Day 196.|Time to relapse of psoriasis was not analyzed due to the small number of participants enrolled and who achieved PASI-50 and entered the observation follow-up phase.||||||
1248692|NCT00521339|Secondary|Time to Achieve PASI-75 During Treatment Phase|Time to achieve PASI-75 during treatment phase was not analyzed. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.||Time to achieve PASI-75 was not analyzed, due to the small number of participants enrolled and who achieved PASI-75.||||||
1249350|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline up to Week 48||up to week 48|||||||
1249351|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline up to Week 24||up to week 24|||||||
1248693|NCT00521339|Secondary|Time to Clinically Relevant Response (Time to Achieve PASI-50) During Treatment Phase|Time to clinically relevant response (time to achieve PASI-50) during treatment phase was not analyzed. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.||Time to achieve PASI-50 was not analyzed since the study enrolled a small number of participants and the number of participants who achieved PASI-50 was even smaller.||||||
1248694|NCT00521339|Secondary|Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) Involvement at Week 12|The BSA estimate was based on the palm area of the hand of the participant which equates to 1% of the total body surface area.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.|||Percent change in BSA||Standard Deviation|Mean
1248695|NCT00521339|Secondary|Maximal PASI Response Documented for Each Participant During Treatment Phase|PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.|Baseline to Week 12|Maximal PASI response was not analyzed since similar information was captured in change in psoriasis area severity Index (PASI) score at Day 85, which is week 12.||||||
1248696|NCT00521339|Secondary|Percentage of Participants Who Achieved a PASI-50 Score at Week 12|PASI -50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.|||percentage of participants||95% Confidence Interval|Number
1248697|NCT00521339|Secondary|Percentage of Participants Who Achieved a PASI-75 Score at Week 12|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.|||percentage of participants||95% Confidence Interval|Number
1248698|NCT00521339|Secondary|Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12|The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.|Baseline and Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.|||percent change||Standard Deviation|Mean
1248699|NCT00521339|Secondary|Percentage of Participants With at Least a 1 Point Reduction on 0 to 5 Point Scale From Baseline in Static Physician Global Assessment (sPGA) at Week 12|The static Physician’s Global Assessment (sPGA) rated the investigator’s overall clinical assessment of a participants plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Decreases in sPGA correspond to clinical improvement.|Baseline and Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. Last Observation Carried Forward.|||percentage of participants||95% Confidence Interval|Number
1248700|NCT00521339|Primary|Treatment Emergent Adverse Events (TEAEs) During the Treatment Phase|"TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.~Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event."|Week 0 to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.|||participants|||Number
1248701|NCT00521144|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR|Every 6 weeks, assessed up to 30 days|Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.|||participants|||Number
1248702|NCT00521079|Secondary|Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)|To evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.|Baseline and 1 Year||||Percentage of subjects|||Number
1248703|NCT00521079|Primary|Rate of System and Procedure-related Serious Adverse Events (SAEs).|To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.|1 Year||||Events|||Number
1248704|NCT00521079|Primary|Percentage of Excess Weight Loss (EWL) With the Maestro System|Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)|Baseline and 1 Year||||Percentage of excess weight loss||Standard Error|Mean
1248705|NCT00521053|Secondary|Overall Survival|1-year survival|52 weeks|ITT participants|||percentage of participants|||Number
1248706|NCT00521053|Post-Hoc|Rate of Complete Response|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Complete Response Rate (CRR) = %CR.|52 weeks|ITT participants having all baseline disease injected with PV-10|||percentage of participants||95% Confidence Interval|Number
1248707|NCT00521053|Secondary|Progression Free Survival (PFS)|Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or significant worsening of non-target disease (e.g., a measurable increase in non-target lesions or the appearance of new lesions) indicative of disease progression.|52 weeks||||Months||95% Confidence Interval|Median
1248708|NCT00521053|Secondary|Objective Response Rate of Untreated Bystander Lesions|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for designated, untreated cutaneous or subcutaneous bystander lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all bystander lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of bystander lesions; Objective Response Rate (ORR) = %CR + %PR.|52 weeks|ITT participants having at least one uninjected dermal bystander lesion designated at baseline (some ITT participants did not have at least one bystander lesion).|||percentage of participants||95% Confidence Interval|Number
1248709|NCT00521053|Primary|Objective Response Rate (ORR) of PV-10 Treated Lesions|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.|52 weeks|ITT participants|||percentage of participants||95% Confidence Interval|Number
1248710|NCT00521014|Primary|Progression-free Survival Rate|"after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as:~≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR~appearance of any new lesions"|up to 3 years||||years||Full Range|Mean
1248711|NCT00521001|Secondary|Confirmed Response Rate (Complete Response and Partial Response)|Confirmed response rates will be evaluated by dividing the number of confirmed responders (i.e. patients that achieve a CR or PR on consecutive evaluations) by the total number of evaluable patients. Confidence intervals for the true response rate will be calculated using the properties of the binomial distribution.|Up to 5 years||||percentage of confirmed responses||95% Confidence Interval|Number
1248712|NCT00521001|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from registration to the earliest date documentation of disease progression; Up to 5 years||||months||95% Confidence Interval|Median
1248713|NCT00521001|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause; Up to 5 years||||months||95% Confidence Interval|Median
1249352|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8||up to week 8|||||||
1249353|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat||up to 48 weeks|||||||
1248714|NCT00521001|Primary|9-week Progression-free Survival Rate|The primary endpoint of this trial is the 9 week PFS rate. A patient is a success if they are progression free at their cycle 2 evaluation (approximately 9 weeks post registration). All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 9-week PFS rate (evaluable patients). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. If some patients are lost to follow up prior to their cycle 2 evaluation, the Kaplan-Meier method will be used to estimate the 9 week PFS rate. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 9 weeks||||proportion of patients||95% Confidence Interval|Number
1248715|NCT00520975|Other Pre-specified|VEGF Levels in Breast Tumor by Immunohistochemistry Assay (Tumor Sample Has Not Been Analyzed Yet, no Results Could be Reported)|Tissue sections from the primary or metastatic paraffin blocks were subjected to VEGF immunohistochemistry (IHC). The VEGF cytoplasmic staining intensity was evaluated semiquantitavely using a classification from 0 to 3, with 0 representing lack of staining, 1 = low staining intensity, 2 = intermediate staining intensity and 3 = strong staining intensity. The fraction of positively staining cells will be determined as well (0 = lack of staining, 1 ≤ 1% cell staining, 2 = 1 – 10% cell staining, 3 = 10 – 50% cell staining, 4 = 50 – 90% cells staining and 5 ≤ 90% cells staining) (48). Staining intensity score zero and fraction of positively staining cells of ≤ 1% (scores zero and 1) will be considered as absence of staining and therefore negative overexpression of VEGF.|assessed at baseline|||||||
1248716|NCT00520975|Other Pre-specified|Number of Circulating Tumor Cells at Baseline|Number of circulating tumor cells per 7.5mL blood were counted prior to starting protocol therapy|assessed at baseline prior to starting protocol therapy|Patients who had blood sample drawn at baseline prior to starting protocol therapy|||number of cells per 7.5 mL blood||Full Range|Median
1248717|NCT00520975|Other Pre-specified|Change in Level of Experiencing Side Effects Between Baseline and Cycle 6 Induction|Participants indicated their level of experiencing side effects across 1 item (Functional Assessment of Cancer Therapy [FACT] item G5) on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient, ranged from 0 to 4 with a higher score representing better quality of life (QOL).|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their level of experiencing side effects using FACT item G5 at both baseline and cycle 6 induction|||scores on a scale||Full Range|Median
1248718|NCT00520975|Other Pre-specified|Change in Neurotoxicity Level Between Baseline and Cycle 6 Induction|Participants indicated their level of neurotoxicity symptoms across 4 items using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient ranged from 0 to 16 with higher scores representing fewer neurotoxic symptoms.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their neurotoxicity level using FACT/GOG-Ntx scale at both baseline and cycle 6 induction|||scores on a scale||Full Range|Median
1248719|NCT00520975|Other Pre-specified|Change in FACT/NCCN Breast Symptom Index (FBSI) Between Baseline and Cycle 6 Induction|Participants indicated their level of breast symptoms across 8 items using the Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) FBSI scale, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient, ranged from 0 to 32 with higher scores representing fewer symptoms.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their fatigue level using FACIT Fatigue subscale at both baseline and cycle 6 induction|||scores on a scale||Full Range|Median
1248720|NCT00520975|Other Pre-specified|Change in Fatigue Level Between Baseline and Cycle 6 Induction|Fatigue level was measured using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue subscale. Participants indicated their level of fatigue across 13 items, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient was calculated by taking the reverse of each item (unless specified not to), taking the sum of those items, multiplying the sum by the number of items in the scale, and then dividing that number by the number of answered items. Total score ranged from 0 to 52 with higher scores representing less fatigue.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their fatigue level using FACIT Fatigue subscale at both baseline and cycle 6 induction|||scores on a scale||Full Range|Median
1248721|NCT00520975|Secondary|Number of Patients Experiencing Congestive Heart Failure|Clinical congestive heart failure (CHF) was assessed using Left Ventricular Ejection Fraction (LVEF) and symptom information via the Cardiac Toxicity Form as well as symptom information collected via the Adverse Event Form. Clinical CHF was defined as symptomatic decline in LVEF to below the lower limit of normal (LLN) or symptomatic diastolic dysfunction.|assessed every 3 months while on treatment and at 3 months post treatment|All patients who began protocol treatment|||participants|||Number
1248722|NCT00520975|Secondary|Overall Response Rate|Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all randomized patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).|assessed at baseline, every 12 weeks while on treatment, then very 3 months if patient is <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years from study entry until disease progression|All randomized patients|||proportion of participants||95% Confidence Interval|Number
1248723|NCT00520975|Secondary|Proportion of Progression-free at 6 Months|Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Proportion of progression-free at 6 months was calculated using the Kaplan-Meier method.|assessed at baseline, at 3 and 6 months after study entry|All randomized patients|||proportion of participants||95% Confidence Interval|Number
1248725|NCT00520975|Primary|Progression-free Survival|Progression-free survival (PFS) was defined as time from date of randomization to first disease progression, new second breast primaries, or to death from any cause, whichever occurred first, otherwise cases were censored at date last documented to be free of progression. Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the median PFS.|assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years|All randomized patients|||Months||95% Confidence Interval|Median
1248726|NCT00520936|Secondary|Pharmacogenomics - Measure the Response of Genes Related to Toxicity|The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature.|baseline|The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here.|||Correlation coefficient|||Number
1248727|NCT00520936|Secondary|Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug|AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator.|every cycle (up to 2 years and 7 months)|All treated participants.|||Participants|||Number
1248728|NCT00520936|Primary|Percentage of Participants With Overall Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent [%])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)*100.|baseline to measured progressive disease (up to 1 year)|All treated participants.|||Percentage of Participants|||Number
1248729|NCT00520845|Other Pre-specified|Changes in Urinary PGE-M and Survival as Assessed by Immunohistochemistry||At 1 year|data is not available. no analysis done||||||
1248730|NCT00520845|Other Pre-specified|Effect of Celecoxib on Urinary Metabolites of PGE2, PG12 and Thromboxane||At 1 year|data is not available. no analysis done||||||
1248731|NCT00520845|Secondary|Time to Progression|Estimated probable duration from on‐study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|2 years from date of registration|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.|||days||95% Confidence Interval|Median
1248732|NCT00520845|Secondary|Overall Response Rate|Overall response rate is measured by complete response + partial response. Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On‐treatment date to date of disease progression (assessed at 6 weeks up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.|||participants||95% Confidence Interval|Number
1248733|NCT00520845|Primary|Median Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|2 years from date of registration|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1248734|NCT00520767|Secondary|Overall Hematologic Response Rate (OHR)||Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.|||||||
1248735|NCT00520767|Secondary|Toxicity, Including Neurotoxicity||Day 1 of Each Cycle|||||||
1248736|NCT00520767|Secondary|Organ Response Rate (OrR)||Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.|||||||
1248737|NCT00520767|Secondary|Change in Quality of Life From Baseline as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Questionnaire.||At the start of each cycle|||||||
1248738|NCT00520767|Secondary|Time to Treatment Failure||Day 1 of Each Cycle|||||||
1248739|NCT00520767|Secondary|Overall Survival||Day 1 of Each Cycle and every 12 weeks after last treatment cycle|||||||
1248740|NCT00520767|Primary|Complete Hematologic Response||Up to 12 months|Individuals evaluable for response|||participants|individuals||Number
1248741|NCT00520741|Secondary|Patient's Global Impression of Change (PGIC) From Baseline To Last Visit|"For the assessment of the Patient’s Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject’s functional status.The subject was asked to answer the following:~Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.)~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Baseline; Last Visit (approximately 27 weeks)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).|||participants|||Number
1248742|NCT00520741|Secondary|Clinical Global Impression of Change (CGIC) From Baseline To Last Visit|"For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject’s clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject’s functional status. He was asked the following:Please check the number that best describes the subject’s condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Baseline; Last Visit (approximately 27 weeks)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).|||participants|||Number
1248743|NCT00520741|Secondary|Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)|Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.|Visit 9 - Visit 12 (approximately 10 weeks)|The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs).This subset of the FAS included subjects who entered the Maintenance Phase but who never achieved Lacosamide (LCM) monotherapy.|||days||Full Range|Median
1248744|NCT00520741|Secondary|Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period|"Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112:~Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis~Withdrawal due to AE with onset during the Maintenance Phase~Withdrew prematurely due to lack of efficacy during the Maintenance Phase~The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy.~The secondary analysis is only conducted on the Lacosamide 400 mg/day group."|16 Weeks Maintenance Period (approximately 112 days)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).|||percentage of subjects|||Number
1248745|NCT00520741|Secondary|Time to First Occurrence of Any Exit Event During The Maintenance Period|The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.|16 Weeks Maintenance Period (approximately 112 days)|The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs). In addition to being a member of FAS, subjects also met at least one of the exit criterion noted under the Primary Outcome Measure.|||days||Full Range|Median
1248746|NCT00520741|Primary|Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)|"Pre-defined exit criteria:~A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase~A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase.~Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion~Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization~A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation~Status epilepticus, or new onset of serial/cluster seizures"|16 Weeks Maintenance Period (approximately 112 days)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (ie, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).~The primary analysis is only conducted on the Lacosamide 400 mg/day group."|||percentage of subjects|||Number
1248747|NCT00520676|Secondary|Number of Participants With Adverse Events (AEs)|Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on safety population. This population includes all participants with non-squamous histology who received at least one dose of study drug. Participants were analysed according to treatments they actually received.|||participants|||Number
1248748|NCT00520676|Secondary|Survival Without Grade 4 Toxicity|Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.|Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.|||participants||95% Confidence Interval|Median
1248759|NCT00520572|Primary|American College of Rheumatology 20 Response (ACR20) at 6 Months|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment|6 months||||Participants|||Number
1248749|NCT00520676|Secondary|Survival Without Clinically Important Grade 3 or 4 Toxicity|Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least one dose of the study drug according to the treatment the participants were assigned.|||months||95% Confidence Interval|Median
1248750|NCT00520676|Other Pre-specified|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on tumour response qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.|||months||95% Confidence Interval|Median
1248751|NCT00520676|Secondary|Percentage of Participants With Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on tumour response-qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.|||percentage of participants||95% Confidence Interval|Number
1248752|NCT00520676|Secondary|Progression-free Survival (PFS)|Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This set includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.|||months||95% Confidence Interval|Median
1248753|NCT00520676|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.|||months||95% Confidence Interval|Median
1248754|NCT00520676|Primary|Survival Without Grade 3 or 4 Toxicity|"Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.~Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact."|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.|||months||95% Confidence Interval|Median
1248755|NCT00520572|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months’ treatment, calculated as score at 6 months minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).|Baseline to 6 months||||Composite score||Standard Deviation|Mean
1248756|NCT00520572|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of disease activity; and ESR) after 6 months’ treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).|Baseline to 6 months||||Composite score||Standard Deviation|Mean
1248757|NCT00520572|Secondary|American College of Rheumatology 70 Response (ACR70) at 6 Months|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment|6 months||||Participants|||Number
1248758|NCT00520572|Secondary|American College of Rheumatology 50 Response (ACR50) at 6 Months|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment.|6 months||||Participants|||Number
1248760|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)|PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined without malign lesions <=5mm.|within < 2 weeks after PET/MRI|lesion based (malignant lesions >5mm, n=98) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)|||lesions|Participants||Number
1248761|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)|PET positive lesions in patients with Gleason >6(3+3),n=43 were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative & positive predictive values were determined.|within < 2 weeks after PET/MRI|"lesion based (patients with Gleasons Score >6(3+3),n= 43) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38).~Gleason Grades: 1+2=well differentiated (rare), 3=moderately diff., 4=poorly diff., 5=undifferentiated~Gleason Score = histological primary grade + secondary grade (min=2,max=10)"|||lesions|Participants||Number
1248762|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients|PET positive lesions (n=128) were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined.|within < 2 weeks after PET/MRI|Comparison of lesion based (128)imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients = 38).|||lesions|Participants||Number
1248763|NCT00520546|Primary|Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings|PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.|within < 2 weeks after PET/MRI|Comparison of imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients).|||participants|||Number
1248764|NCT00520494|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25)|The SDS comprised all treated patients.|||participants|||Number
1248765|NCT00520494|Secondary|Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25).|At Weeks 12 and 25|The SDS comprised all treated patients.|||participants|||Number
1248766|NCT00520494|Secondary|Rate of Local Reactions by Severity and Relatedness|"The rate was the number of local reactions over the number of infusions administered.~Local reactions included:~infusion site: erythema, pain, pruritus, rash, reaction, swelling;~injection site: bruising, erythema, irritation, pruritus, swelling;~edema peripheral;~tenderness;~erythema;~pruritus; and~skin swelling.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.|||local reactions per infusion|Participants||Number
1248767|NCT00520494|Secondary|Number of Patients With Local Reactions by Severity and Relatedness|"Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.|||participants|||Number
1248783|NCT00520494|Secondary|Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19||On Day 19|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||proportion of participants||95% Confidence Interval|Number
1248784|NCT00520481|Secondary|Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks||Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only)|Participants who received study drug and had evaluable PK samples for Cmax on Cycle 1 only in 10 mg/kg group.|||µg/ml||Geometric Coefficient of Variation|Geometric Mean
1248768|NCT00520494|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.|||AEs per infusion|Participants||Number
1248769|NCT00520494|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The Safety data set (SDS) comprised all treated patients.|||participants|||Number
1248770|NCT00520494|Secondary|Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)|The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state.|At study completion, approximately Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the CHQ-PF50 questionnaire were available.|||units on a scale||Standard Deviation|Mean
1248771|NCT00520494|Secondary|Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)|The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At study completion, approximately Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the SF-36 questionnaire were available.|||units on a scale||Standard Deviation|Mean
1248772|NCT00520494|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.|For the duration of the study, up to approximately 25 weeks|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||participants|||Number
1248773|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.|||mg/L||Standard Deviation|Mean
1248774|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12||On Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.|||mg/L||Standard Deviation|Mean
1248775|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.|||IU/mL||Standard Deviation|Mean
1248776|NCT00520494|Primary|Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12||On Day 12|The intention-to-treat (ITT) data set comprised all patients who were treated with the study drug and completed Day 12.|||proportion of patients||95% Confidence Interval|Number
1248777|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12||On Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.|||IU/mL||Standard Deviation|Mean
1248778|NCT00520494|Secondary|Total Serum IgG Trough Levels at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 total serum IgG results were available.|||g/L||Standard Deviation|Mean
1248779|NCT00520494|Secondary|Total Serum IgG Trough Levels on Day 12||On Day 12|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||g/L||Standard Deviation|Mean
1248780|NCT00520494|Secondary|Overall Rate of Infections|"Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days.~Infections were classified as all AEs with the system organ class infections and infestations."|For the duration of the study, up to approximately 25 weeks|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||infections per patient year|Participants|95% Confidence Interval|Number
1248781|NCT00520494|Secondary|IgG Increase (Change From Baseline) on Day 12||Baseline to Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which IgG results, as required for the analysis, were available.|||g/L||Standard Deviation|Mean
1248782|NCT00520494|Secondary|Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26||On Day 26|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||proportion of participants||95% Confidence Interval|Number
1249354|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF||up to 48 weeks|||||||
1248786|NCT00520481|Secondary|Progression-Free Survival (PFS) Rate at 6 Months|PFS rate was the proportion of participants who had stable disease (SD), PR, or CR and were alive at 6 months after receiving their first dose of study medication. Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in sum of longest diameter of target lesions, and SD was defined as shrinkage or increase in tumor size that did not meet the above criteria. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. Percentage of participants = (Number of participants with PFS at 6 months / total number of participants analyzed) *100.|From randomization up to 48.6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg - 7; Cixutumumab 20 mg/kg = 2.|||percentage of participants||95% Confidence Interval|Number
1248787|NCT00520481|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate|Percentage of participants with a PSA decrease of at least 50% from baseline PSA provided the participant had a PSA value of at least 2 nanograms per milliliter (ng/ml) at baseline. Percentage calculated as: (number of participants with PSA response rate / total number of participants) *100.|From Randomization up to 6.21 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1248788|NCT00520481|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate)|Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of longest diameter of target lesions|From Randomization up to progressive disease (49.2 months)|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1248789|NCT00520481|Secondary|Time to Radiographically Evident Disease Progression|This is the time between first dose and radiographic progression defined as either: progression of measurable or non measurable lesions using the RECIST v 1.0, evidence of progression by bone scan or new skeletal event including new pathologic bone fracture, new bone lesion requiring radiation or surgery, or spinal cord/nerve root compression. Participants without evidence of disease progression at the date of latest tumor or bone radiograph were censored.|From first dose of study drug until radiographic progression (up to 48.6 months)|ITT population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg = 9; Cixutumumab 20 mg/kg = 2.|||months||95% Confidence Interval|Median
1248790|NCT00520481|Secondary|Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs)|Clinically significant events were defined as SAEs and other non-serious adverse events AEs. Participants who died due to progressive disease (PD), AEs while on treatment or died during the 30 day post-treatment are included. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|From randomization up to 49.2 months (and 30 day follow-up)|Safety population: All participants who received any dose of Cixutumumab.|||Participants|||Count of Participants
1248791|NCT00520481|Primary|Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks||Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h post dose for Cycle 4; predose and 1 h postdose for Cycles 5 to 9)|Participants who received study drug and had evaluable pharmacokinetic (PK) samples for Cmax on Cycle 1 and Cycle 5.|||micrograms/milliliter (µg/ml)||Geometric Coefficient of Variation|Geometric Mean
1248792|NCT00520481|Primary|Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks||Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h postdose for Cycle 4; predose and 1 h post dose for Cycles 5 to 9)|Zero participants were analyzed as the data were not estimable accurately due to the study sampling schedule.||||||
1248793|NCT00520481|Primary|Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab|cTTP was the time from the first day of treatment to the earliest onset of 1 of the following: tumor progression by Response Evaluation Criteria In Solid Tumors [RECIST, version 1.0] criteria: unequivocal evidence of progression by bone scan, new skeletal events, symptomatic progression (for participants without measurable disease), or other clinical events attributable to prostate cancer that in the opinion of the investigator require major interventions. Participants without tumor progression at data cut-off were censored.|From first dose of study drug until progressive disease (Up to 49.2 months)|ITT population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg =7; or Cixutumumab 20 mg/kg = 2.|||months||95% Confidence Interval|Median
1248794|NCT00520468|Primary|Number of Participants With Response|Periodic bone marrow samples (every 3-6 months) to check cells related to disease before/during/after study. Response classifications categorized by the International Working Group Response Criteria for Myelodysplastic Syndrome (MDS) as: Complete Remission, Partial Response, Hematologic Improvement or No Response.|Response evaluation within first 3 months from start of therapy, then every 3 to 6 months|All treated patients on study included in analysis.|||participants|||Number
1248795|NCT00520403|Primary|PFS - Time to Event|PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method|Days 0, 91, 182, 273, 365, 456, and 547|ITT population.|||days||Standard Error|Median
1248796|NCT00520403|Secondary|Overall Survival (OS)|OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.|Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)|Two of 25 participants died during the course of the study, thus, median overall survival could not be analyzed.|||weeks||Full Range|Median
1249355|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored||up to 48 weeks|||||||
1249356|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat||up to 48 weeks|||||||
1249357|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF||up to 48 weeks|||||||
1248798|NCT00520403|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.|Days 0, 91, 182, 273, 365, 456, and 547|Intent-to-treat (ITT) population: all participants, even those who withdrew from the study prematurely, who received at least 1 dose of study medication and for whom the primary efficacy variable was measured at least once during the time when the participant received study medication.|||percentage of participants|||Number
1248799|NCT00520351|Primary|Subjective Comfort Rating|Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.|2 weeks||||Units on a scale||95% Confidence Interval|Mean
1248800|NCT00520351|Primary|In-vivo Wettability|Pre-lens non-invasive tear breakup time|2 weeks||||Seconds||95% Confidence Interval|Least Squares Mean
1248801|NCT00520351|Primary|Low Contrast Visual Acuity|"Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.~10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."|2 weeks|Analysis was per protocol|||logMAR||Standard Deviation|Mean
1248802|NCT00520351|Primary|High Contrast Visual Acuity|"High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.~10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."|2 weeks||||logMAR||Standard Deviation|Mean
1248803|NCT00520299|Secondary|Correlation Between ASS Tumor Expression and Clinical Response|Expression of ASS was analyzed by immunohistochemistry in tumor samples (archived or biopsy) at baseline and compared with overall best clinical response per RECIST. ASS tumor expression is categorized as either negative or ≤ 5% positive tumor cells.|Up to 12 months|Includes all subjects who had an ASS antigen assay performed at Baseline|||participants|||Number
1248804|NCT00520299|Secondary|Summary of ADI-PEG 20 Immunogenicity Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for detection of anti-ADI antibodies.|Up to 12 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.|||log 10 U/mL||Standard Deviation|Mean
1248805|NCT00520299|Secondary|Summary of Plasma Citrulline Levels Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for plasma citrulline levels.|Up to 9 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.|||uM||Standard Deviation|Mean
1248806|NCT00520299|Secondary|Summary of Plasma Arginine Levels Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for plasma arginine levels.|Up to 9 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.|||uM||Standard Deviation|Mean
1248807|NCT00520299|Secondary|Summary of ADI-PEG 20 Plasma Concentrations Over Time|Blood samples were collected on day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for ADI-PEG 20 plasma concentrations.|Up to 12 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.|||nM||Standard Deviation|Mean
1248808|NCT00520299|Secondary|Metabolic Tumor Response|Metabolic tumor responses were evaluated using fluorodeoxyglucose (FDG) positron emission tomography (PET) at baseline, on day 4, and at the end of every cycle.|Every 8 to 9 weeks for up to 12 months|Includes all subjects who completed the study as planned or had tumor progression during the study|||participants|||Number
1248809|NCT00520299|Primary|Best Overall Clinical Tumor Response|Clinical tumor responses were evaluated using disease imaging (CT preferred) performed at baseline and at the end of every cycle. Responses were categorized according to RECIST. Per RECIST for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Every 8 to 9 weeks for up to 12 months|Includes all subjects who completed the study as planned or had tumor progression during the study|||participants|||Number
1248810|NCT00520299|Primary|Assessment of Safety and Tolerability of ADI-PEG 20|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.|Every 1 to 2 weeks for up to 12 months|Safety Analysis Set (all subjects who received at least 1 dose of ADI-PEG 20)|||participants|||Number
1248811|NCT00520286|Secondary|Reduction of Craving|Number of subjects with 21 or more consecutive days of abstinence|21 days||||Participants|||Count of Participants
1248812|NCT00520286|Primary|Abstinence (Week 1 - 12)|Number of participant who abstained from methamphetamine from weeks 1 through 12|Weeks 1 - 12||||Participants|||Count of Participants
1248813|NCT00520234|Secondary|Subjects With 1 or More Serious Drug-related Adverse Event(s)||Up to 14 days after end of therapy|Safety population, defined as all subjects who received at least one dose of study drug.|||participants|||Number
1248814|NCT00520234|Secondary|Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event||Up to 14 days after end of therapy|Safety population, defined as all subjects who received at least one dose of study drug.|||participants|||Number
1248815|NCT00520234|Secondary|Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.||Hospital discharge|||||||
1248816|NCT00520234|Secondary|Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.||Within 14 days after end of therapy|||||||
1248817|NCT00520234|Secondary|Time to Beta Glucan Negativity in Pre-emptive Phase.||Within 14 days after end of therapy|||||||
1248818|NCT00520234|Secondary|Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.||Within 7 days after end of therapy|||||||
1248823|NCT00520234|Primary|Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.|Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.|Within 7 days after end of therapy|Modified intent-to-treat population, defined as subjects who received at least one dose of study drug and did not have baseline invasive candidiasis.|||percent of participants|||Number
1248824|NCT00520130|Secondary|Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations|Cluster of differentiation 3 (CD3)+cluster of differentiation 4 (CD4)+ and CD3+CD8+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, 1, 3, 6, 12 and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.|||Cells/µl||Full Range|Median
1248825|NCT00520130|Secondary|Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations|Cluster of Differentiation 3 (CD3)+CD4+ and CD3+Cluster of Differentiation 8 (CD8)+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, and 1, 3, 6, 12 and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.|||Cells/µl||Full Range|Median
1248826|NCT00520130|Secondary|Immune Reconstitution of Normal Killer (NK) Cells|Cluster of differentiation 3 (CD3) - cluster of differentiation 56 (CD56) + Natural Killer (NK) cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, and 1, 3, 6, 12, and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.|||Cells/µl||Full Range|Median
1248827|NCT00520130|Secondary|Decline in Homeostatic Cytokine Interleukin 7 (IL-7) Post-Transplant|During depletion of lymphocytes during transplant conditioning, levels of homeostatic cytokines increase in the blood. These then decline with the expansion of new donor-derived cells. The rapidity of decline may predict acute graft versus host disease (AGVHD). Decline in cytokine IL-7 will be assessed by the enzyme-linked immunosorbent assay (ELISA).|Day 0, 1 week and 2 weeks|Following the focus on chronic graft-versus host disease (GVHD) as a primary outcome measure in 2011, this measure was not assessed.||||||
1248828|NCT00520130|Secondary|Percentage of Participants With Late Treatment Related Mortality|Any death occurring 28 days or more after transplantation in a patient in continuous remission.|Greater than 28 days after transplantation|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||percentage of participants||95% Confidence Interval|Number
1248829|NCT00520130|Secondary|Early Treatment Related Mortality|Any death occurring within 28 days after transplantation in a patient in continuous remission.|Less than or equal to 28 days after transplantation|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||participants|||Number
1248830|NCT00520130|Secondary|Overall Survival|Time between the first day of transplant to the day of death.|Patients were followed for an average of up to 5 years.|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||Months||95% Confidence Interval|Median
1248831|NCT00520130|Secondary|Days to Engraftment of Lymphocytes|Lymphocyte recovery: designated by the first of 3 consecutive days with absolute lymphocyte count (ALC) above 500/mm(3).|2 years|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||Days||Full Range|Median
1248832|NCT00520130|Secondary|Days to Engraftment of Platelets|Platelet recovery: designated by the first of 7 days where the platelet count remains above 20,000/mm(3) without transfusion support|2 years|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||Days||Full Range|Median
1248833|NCT00520130|Secondary|Days to Engraftment of Neutrophils|Days to engraftment is defined as neutrophil recovery: designated by the first of 3 consecutive days with an absolute neutrophil count (ANC) above 500/mm(3).|2 years|One myeloma patient had graft failure in the AC Arm. 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||Days to neutrophil engraftment||Full Range|Median
1248834|NCT00520130|Secondary|Toxicities|Here are the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|103 months and 22 days||||participants|||Number
1248835|NCT00520130|Secondary|Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD)|Acute GVHD is assessed by the 1994 Consensus Conference on acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.|6 months|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||percentage of participants||95% Confidence Interval|Number
1248859|NCT00519779|Primary|Stimulated ln(IL-6)|"log-transformed stimulated IL-6~Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.~Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intent to treat|||ln(pg/mL)||Standard Error|Least Squares Mean
1249358|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored||up to 48 weeks|||||||
1249359|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat||up to 48 weeks|||||||
1249360|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF||up to 48 weeks|||||||
1248836|NCT00520130|Primary|Changes in CD8 T Cell Receptor Vbeta Repertoire|Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient’s T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.|Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant|The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.|||Divergence index||Full Range|Median
1248837|NCT00520130|Primary|Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire|Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient’s T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.|Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant|The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.|||Divergence index||Full Range|Median
1248838|NCT00520130|Primary|Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells|The percentage of CCR7+CD45RA+ naïve T cells within the CD4 and CD8 T cell populations was determined by flow cytometry.|Recipient recovery at 6, 12 and 24 months post transplant|A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.|||% of naive (CCR7+CD45RA+) CD8 Cells||Full Range|Median
1248839|NCT00520130|Primary|Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells|The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry.|Recipient recovery at 6, 12 and 24 months post transplant|A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.|||% of naive (CCR7+CD45RA+) CD4 Cells||Full Range|Median
1248840|NCT00520130|Primary|Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD)|Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. First the individual organ scoring is done, and then based on that the Global score is determined (mild-moderate-severe). See Citation: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria.|2 years post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||percentage of participants||95% Confidence Interval|Number
1248841|NCT00520130|Primary|Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD)|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.|6 months|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||percentage of participants||95% Confidence Interval|Number
1248842|NCT00520039|Secondary|Change in Middle Ear Effusion Immediately After OMM at Study Visit 3|"For this study, the tympanogram was chosen to measure middle ear effusion. For the SC+OMT Group during study visit 3, three tympanogram readings from each ear included in the study were taken prior to, and immediately after the intervention. The tympanograms were sent to the blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed between “normal” and “abnormal” from before and after the OMM was computed."|Before and immediately after OMM at study visit 3||||ears|ears||Number
1248843|NCT00520039|Secondary|Change in Middle Ear Effusion Immediately After OMM at Study Visit 2|"For this study, the tympanogram was chosen to measure middle ear effusion. For the SC+OMT Group during study visit 2, three tympanogram readings from each ear included in the study were taken prior to, and immediately after the intervention. The tympanograms were sent to the blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed between “normal” and “abnormal” from before and after the OMM was computed."|Before and immediately after OMM at study visit 2||||ears|ears||Number
1248860|NCT00519779|Primary|Serum ln(TNF-a)|"log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)~All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual’s cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||ln(pg/mL)||Standard Error|Least Squares Mean
1248844|NCT00520039|Primary|Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media|"For this study, the tympanogram was chosen to measure middle ear effusion. Three tympanogram readings from each ear included in the study were taken at the beginning of each of 5 Study Visits. For the intervention group, a second set of 3 tympanograms was taken immediately after the OMM on Visits 1, 2 and 3. All tympanograms were sent to a blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed from baseline over 4 weeks was computed by crosstabulating the intervention group by the normal/abnormal changes in tympanograms."|1 month|4 ears, from 2 subjects, were removed from the SC+OMM group final analysis due to no interpretable readings obtained during the study.|||Ears|Ears||Number
1248845|NCT00520013|Secondary|Consolidation Objective Response Rate|Consolidation objective response (OR) was based on RECIST 1.0 criteria with OR defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. If CA125 disease then OR based on Rustin criteria is a 50% decrease in serum CA125 level from two initially elevated samples confirmed by a 4th sample.|Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year.|The analysis dataset is comprised of all patient who started consolidation treatment.|||proportion of patients||95% Confidence Interval|Number
1248846|NCT00520013|Primary|Consolidation Treatment-related Toxicity Rate|Consolidation treatment-related toxicity rates based on CTCAEv3 were defined as rates of maximum grade 3 or higher toxicity events with attribution possible, probable or definite occurring during consolidation treatment and up to 30 days post-treatment.|Assessed every cycle during consolidation treatment and up to 30 days post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.|The analysis dataset is comprised of patients who were randomized to consolidation treatment.|||percentage of participants||95% Confidence Interval|Number
1248847|NCT00520013|Primary|Consolidation Progression-Free Survival|Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to >/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation.|Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.|The analysis dataset is comprised of patients randomized to consolidation treatment.|||months||95% Confidence Interval|Median
1248848|NCT00519896|Secondary|Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|At 30 days from the last dose of study treatment and then for 2 years||||months||95% Confidence Interval|Median
1248849|NCT00519896|Secondary|Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0|Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded.|On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years|All patients that received at least one dose of sunitinib malate were included in the analysis.|||participants|||Number
1248850|NCT00519896|Primary|Overall Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,"|At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||Participants|||Count of Participants
1248851|NCT00519831|Secondary|Progression-free Survival||after cycle 2, within 2 weeks of completing cycle 4|Data not collected due to early study termination.||||||
1248852|NCT00519831|Secondary|Overall Survival||Every 30 days|Data not collected due to early study termination.||||||
1248853|NCT00519831|Secondary|Duration of Response||After cycle 4|Data not collected due to early study termination.||||||
1248854|NCT00519831|Primary|Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.|Baseline, after cycle 2, within 2 weeks of completing cycle 4||||Participants|||Count of Participants
1248855|NCT00519818|Secondary|17 Hydroxyprogesterone at 08.00 Hours||Cortef after one week compared with Chronocort after one month||||nmol/l||Standard Deviation|Mean
1248856|NCT00519818|Primary|Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).||Cortef after one week, Chronocort after one month|Per protocol|||h*nmol/l||Standard Error|Mean
1249361|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored||up to 48 weeks|||||||
1248862|NCT00519779|Primary|Serum ln(IL-6)|"log-transformed serum Interleukin-6 (IL-6)~Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.~Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||ln(pg/mL)||Standard Error|Least Squares Mean
1248863|NCT00519649|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|After the challenge dose of HBV vaccine.||||Participants|||Count of Participants
1248864|NCT00519649|Secondary|Number of Participants Reporting Unsolicited Adverse Events|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after the challenge dose of HBV vaccine.||||Participants|||Count of Participants
1248865|NCT00519649|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache|During the 4-day follow-up period after the challenge dose of HBV vaccine.||||Participants|||Count of Participants
1248866|NCT00519649|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling|During the 4-day follow-up period after the challenge dose of HBV vaccine.||||Participants|||Count of Participants
1248867|NCT00519649|Secondary|Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL|Before challenge dose of HBV vaccine|Analysis was performed on subjects from the According-to-Protocol cohort for analysis of antibody persistence for whom serological results were available at pre-HBV vaccine challenge blood sampling time point|||Participants|||Count of Participants
1248868|NCT00519649|Primary|Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)|One month after the challenge dose of HBV vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity|||Participants|||Count of Participants
1248869|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist|"Subjects assessed preference over gentleness of mist for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
1248870|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use|"Subjects assessed preference over ease of use for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
1248871|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat|"Subjects assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
1248872|NCT00519636|Secondary|Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
1248873|NCT00519636|Secondary|Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population. A subject in the FP/FF group had no baseline daytime TNSS; however, does have a baseline nighttime TNSS, that value serves as the baseline 24-hour TNSS. Therefore there are 90 24-hour & nighttime TNSS observations available in the FP/FF group, but only 89 daytime TNSS observations.|||Scores on a scale||Standard Error|Mean
1249362|NCT00517192|Secondary|Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.||48 weeks of treatment|||||||
1249363|NCT00517192|Secondary|Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.||48 weeks of treatment|||||||
1248874|NCT00519636|Primary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor|"Subjects assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
1248875|NCT00519636|Primary|Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
1248876|NCT00519623|Primary|Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)|Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported.|Glucose infusion rates were adjusted every 10 minutes as necessary||||mg/kg/min||Standard Error|Mean
1248877|NCT00519623|Secondary|Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients|Skin response was evaulated by visual skin scoring using a modified Draize scale and transepidermal water loss (TEWL) measurements. The transdermal insulin patch was well-tolerated with mild transient erythema at the application site.|Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal||2010-11-30|11/2010||||
1248878|NCT00519623|Primary|Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)|Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported.|Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours|Number of subjects completed|||uU/mL||Standard Error|Mean
1248879|NCT00519584|Secondary|Total Opioid Consumption|cumulative opioid consumption in oral oxycodone equivalents (mg) during the first 3 days after surgery.|during first 3 days after surgery||||mg||Inter-Quartile Range|Median
1248880|NCT00519584|Secondary|Maximum VRS Pain Scores at Rest|Verbal rating scales (VRS): a list of adjectives describing different levels of pain intensity with 0 = no pian and 10 = extremely intense pain. An adequate VRS of pain intensity should include adjectives that reflect the extremes of this dimension; from 'no pain' to 'extremely intense pain'. Patients are asked to read over the list of adjectives and select the word or phrase that best describes their level of pain on the scale from 0 to 10.|postoperative day 1 day 2, day 3.||||units on a scale||Inter-Quartile Range|Median
1248881|NCT00519584|Secondary|Time to a Significant Increase in Shoulder Discomfort|the length of time until the patients’ first report of surgical site pain.|during postoperative day 1 to 3||||hours||Inter-Quartile Range|Median
1248882|NCT00519584|Primary|the Duration of Analgesia|the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain|surgical date to postoperative day 1 (pod 0 -1 day)||||hours||Inter-Quartile Range|Median
1248883|NCT00519532|Secondary|Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)|"The change in number of nocturias was used to evaluate improvements in sleep disorders.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).|||Nocturias||Standard Deviation|Mean
1248884|NCT00519532|Secondary|Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)|"Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).|||units on a scale||Standard Deviation|Mean
1248885|NCT00519532|Primary|Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)|"The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).|||units on a scale||Standard Deviation|Mean
1248886|NCT00519532|Primary|Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)|"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.~Baseline is defined as first titration visit (T1) of SP915."|Baseline (baseline SP915) and week 13 (End of maintenance)|Full Analysis Set (FAS).|||units on a scale||Standard Deviation|Mean
1248887|NCT00519428|Secondary|Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)|"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) intends to measure quality of life in 16 domains. A summary score is computed by adding the scores and dividing by 16 (or the number of answered items if some are not answered).~The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher score means more satisfaction."|12 weeks|All Randomized Subjects|||units on the Q-LES-Q scale||Standard Deviation|Mean
1248888|NCT00519428|Secondary|Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|12 weeks|All randomized patients; latest available Total SAS score used if week 12 score not available.|||units on the SAS scale||Standard Deviation|Mean
1248889|NCT00519428|Secondary|Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)|"Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression"|12 weeks|age 18-65 with MDD, non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate SSRI/bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.|||units on Hamilton Rating Scale for Depre||Standard Deviation|Mean
1248890|NCT00519428|Secondary|Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12|Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items [HAMD-D 17] > 7 once HAMD-D 17 <= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate.|12 weeks|age 18-65 with MDD, non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate SSRI/bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.|||percentage of participants|||Number
1248891|NCT00519428|Primary|Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7|Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05.|12 weeks|age 18-65 with Major Depressive Disorder (MDD), non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate selective serotonin re-uptake inhibitor (SSRI) and/or bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.|||weeks||Standard Deviation|Mean
1248892|NCT00519376|Secondary|Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The Time to maximum plasma concentration (Tmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Day 1 of each treatment period (up to Study Day 54)|PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed|||Hours||Full Range|Median
1248893|NCT00519376|Secondary|Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The maximum observed plasma concentration (Cmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Day 1 of each treatment period (up to Study Day 54)|PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed|||picograms/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1248894|NCT00519376|Secondary|AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009 using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. AUC defined as area under the plasma concentration curve from time zero to the last quantifiable concentration (AUC(0-t)), and up to 1 hour post-dose (AUC(0-1)) were determined by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Pharmacokinetic (PK) Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed|||picograms.Hour/milliliter (pg.hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1248895|NCT00519376|Secondary|Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium|Blood samples were collected for the measurement of potassium and glucose at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3 and 4 hours post-dose on Day 1of the each treatment period. Whole blood samples (approximately 1.0 milliliter [mL]) was analysed for potassium and glucose using the i-STAT1 portable chemical analyser. The i-STAT1 system is an analyser designed for point of care testing and employs a hand-held chemistry analyzer and disposable cartridges, which in the configuration tested, are capable of measuring potassium, glucose, blood gases, electrolytes, metabolites and coagulation. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. The data is presented as adjusted mean of WM and maximum (max) glucose /minimum (min) potassium.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Millimoles per liter (mmol/L)||Standard Error|Mean
1249364|NCT00517192|Secondary|Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).||48 weeks of treatment|||||||
1248896|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure|Blood pressure (BP) measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. SBP and DBP were recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3, 4 and 6 hours post-dose on Day 1of the each treatment period. SBP and DBP recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum SBP and DBP.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Millimeters of mercury||Standard Error|Mean
1248897|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate|Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. Heart rate was recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1, 2, 3, 4 and 6 hours post-dose on Day 1of each treatment period. Heart rate recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum heart rate.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Beats per minute||Standard Error|Mean
1248898|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the 12-lead ECG. QTcB is the QT interval corrected for heart rate using Bazett's formula; QTcF is the QT interval corrected for heart rate using Fridericia's formula. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. QTcB and QTcF recorded at 20 minutes, 45 minutes, 1, 2, 3, and 4 hours post-dose on Day 1 of each treatment period were used for analysis. The data is presented as the adjusted means of WM and maximum QTc(B) and QTc(F).|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Milliseconds (msec)||Standard Error|Mean
1248899|NCT00519376|Secondary|Mean FEV1 Over 23 and 24 Hours After Dosing|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. The data is presented as adjusted mean of the FEV1 values over 23 and 24 hours after dosing. Changed in trough FEV1 will be analysed using a model with baseline, treatment, period, as fixed effects .|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Mean
1248900|NCT00519376|Primary|Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period|ECG parameters [PR, QRS, RR, QT (uncorrected), QTcB (QT corrected by Bazett's formula) and QTcF (QT corrected by Fridericia's formula) intervals] were measured at Baseline and over the post-dose 24h period at the following scheduled time points: 20 minutes (min), 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline was defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PP Population.|||milliseconds (msec)||Standard Deviation|Mean
1248901|NCT00519376|Primary|Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period|Heart rate (HR) was measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Per Protocol (PP) Population: all participants included in the All Subjects population excluding a participant deemed not to have heart rate or other ECG parameters deemed suitable for evaluation. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Beats per minute(bpm)||Standard Deviation|Mean
1248902|NCT00519376|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period|SBP and DBP were measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1h, 2h, 3h, 4h, 6h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1248903|NCT00519376|Primary|Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of c-reactive protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Milligrams per liter (Mg/L)||Standard Deviation|Mean
1249365|NCT00517192|Primary|Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.||48 weeks of treatment|||||||
1249366|NCT00517075|Secondary|Cortical Excitability||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1248904|NCT00519376|Primary|Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1248905|NCT00519376|Primary|Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of cholesterol, chloride, potassium, sodium, triglycerides, and urea at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1248906|NCT00519376|Primary|Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
1248907|NCT00519376|Primary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1248908|NCT00519376|Primary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of MCH at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 picograms (pg) per cell||Standard Deviation|Mean
1248909|NCT00519376|Primary|Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
1248910|NCT00519376|Primary|Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Proportion of 1.0||Standard Deviation|Mean
1248911|NCT00519376|Primary|Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of reticulocyte and RBCs at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1249367|NCT00517075|Secondary|Cognitive Function||At baseline, the first and last rTMS sessions of each study phase (random and open), and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1248912|NCT00519376|Primary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1248913|NCT00519376|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and white blood cell (WBC) count at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1248914|NCT00519376|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
1248915|NCT00519285|Secondary|Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept|"Serum for detection of anti-drug antibodies (ADA) was collected in patients treated in selected centers only. Samples were analyzed using a titer-based, bridging immunoassay developed and validated to detect ADAs in human serum.~Samples with positive antibody levels were further analyzed using a validated, non-quantitative ligand binding assay to detect neutralizing antibodies Ab).~A participant was considered to have positive antibody levels if antibodies were detected above the quantification limits."|Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug|The analysis was performed on the safety population evaluable for immunogenicity (i.e. exposed to aflibercept with serum samples evaluable for immunogenicity).|||participants|||Number
1248916|NCT00519285|Secondary|Number of Participants With Adverse Events as a Measure of Safety|"Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome or illness observed by the investigator or reported by the participant during the study.~AE were collected at regular intervals throughout the study then graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0)."|From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days|The analysis was performed on the safety population (i.e. all randomized and treated participants according to the treatment actually received). Six participants in the Placebo group who received at least one dose of aflibercept in error were considered in the Aflibercept group.|||participants|||Number
1248917|NCT00519285|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life|"Functional Assessment of Cancer Therapy-Prostate (FACT-P) is a 39-item participant questionnaire that measures the concerns of patients with prostate cancer. It consists of 5 subscales assessing physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate-specific concerns.~FACT-P total score is the sum of the 5 subscores. It ranges from 0 to 156 with higher score indicating better quality of life."|Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first|The analysis was performed on the ITT population evaluable for Health related quality of life (i.e. with baseline and at least one post-baseline evaluable FACT-P questionnaire).|||units on a scale||Standard Deviation|Mean
1248918|NCT00519285|Secondary|Pain Response Rate|Pain response was defined as either a ≥2-point decrease from baseline in Present Pain Intensity (PPI) score without increase in Analgesics Score (AS), or a ≥50% decrease from baseline in AS without increase in the PPI score confirmed at least 3 weeks later. Increases in PPI or AS during the first 12 weeks were ignored in determining pain response.|Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first|The analysis was performed in the ITT population evaluable for pain response (i.e. stable analgesia at baseline and, baseline PPI ≥2 and/or baseline AS ≥10 points).|||percentage of participants||95% Confidence Interval|Number
1248929|NCT00519077|Secondary|Median Progression-free Survival Time|Progression-free survival (PFS) is the number of months during and after Gefitinib treatment during which the cancer did not get worse (progress) as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Progressive disease is associated with at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. All patients developed progressive disease or died during the 9-month observation period.|9 months||||months||95% Confidence Interval|Median
1249368|NCT00517075|Secondary|Smoking Behaviors||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1248919|NCT00519285|Secondary|Pain Progression-free Survival Time|"Pain progression was defined as either ≥1-point increase in Present Pain Intensity (PPI) score or ≥25% increase in Analgesics Score (AS) confirmed at least 3 weeks later, or requirement for palliative radiotherapy. PPI scale is a self-report 0-5 scale to assess pain intensity - a score 0 reflects no pain, a score 5 reflects excruciating pain. AS is a scoring method to assess analgesics consumption. Each analgesic is scored 1 or 4 depending on the analgesic type and dose. AS is the sum of the analgesic scores.~Pain progression-free survival (PFS) time was measured as the time from the date of randomization up to the date of first pain progression or death due to any cause, whichever occurred first.~The median pain-PFS and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of event, the participant was censored at the the date of last assessment without evidence of pain progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population evaluable for pain progression (i.e. with no pain or with stable pain at baseline).~At the cut-off date, pain progression or death had occurred in 507 participants, 263 in the Placebo group and 244 in the Aflibercept group."|||months||95% Confidence Interval|Median
1248920|NCT00519285|Secondary|Prostate Specific Antigen Progression-free Survival Time|"Prostate specific antigen (PSA) progression was defined as ≥25% increase in PSA level confirmed 3 weeks later, above the nadir in participants who had achieved a PSA response, or above the baseline in participants who hadn't achieved a PSA response.~PSA progression-free survival (PFS) time was defined as the time from the date of randomization up to the date of the first documented PSA progression or death due to any cause, whichever occurred first.~The median PSA-PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of PSA progression or death, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed in the ITT population evaluable for PSA progression (i.e. with an evaluable baseline PSA).~At the cut-off date, PSA progression or death had occurred in 1138 participants, 571 in the Placebo group and 567 in the Aflibercept group."|||months||95% Confidence Interval|Median
1248921|NCT00519285|Secondary|Tumor Response Rate in Participants With Measurable Disease|Tumor response was defined as either a Complete Response (disappearance of all target lesions) or a Partial Response (≥30% decrease from baseline in target lesions) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)version 1.0.|Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first|The analysis was performed on the ITT population evaluable for tumor response (i.e. received at least one dose of study drugs (aflibercept/placebo or docetaxel), had no important deviations to protocol and was evaluable for response as per RECIST version 1.0).|||percentage of participants||95% Confidence Interval|Number
1248922|NCT00519285|Secondary|Progression Free Survival Time|"Disease progression was defined as a composite of: Radiological tumor progression (≥20% increase in target lesions, or appearance of at least 2 new bone lesions); PSA progression (≥25% increase in PSA level confirmed 3 weeks later); Pain progression (increase in pain intensity or in analgesic consumption for cancer related pain confirmed 3 weeks later); Radiotherapy for cancer related symptoms; Occurence of Skeletal related events (SRE).~Progression Free survival (PFS) time was measured as the time from the date of randomization up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.~The median PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of disease progression, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population.~At the cut-off date, disease progression or death had occurred in 1184 participants, 592 in each treatment group."|||months||95% Confidence Interval|Median
1248923|NCT00519285|Secondary|Time to Skeletal Related Events|"Skeletal Related Events (SRE) included pathological fractures and/or spinal cord compression, need for bone irradiation, including radioisotopes or bone surgery, change in antineoplastic therapy to treat bone pain.~Time to SRE was defined as the time from the date of randomization to the date of occurence of the first event defining a SRE or death due to any cause, whichever occurred first.~The median time to SRE and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of SRE, the participant was censored at the last date he/she was known to be alive or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population.~At the cut-off date, SRE or death had occurred in 1013 participants, 516 in the Placebo group and 497 in the Aflibercept group."|||months||95% Confidence Interval|Median
1248924|NCT00519285|Secondary|Prostate Specific Antigen Response Rate|Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response.|Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first|The analysis was performed on the ITT population evaluable for PSA response (i.e. with a baseline PSA ≥10 ng/mL).|||percentage of participants||95% Confidence Interval|Number
1248925|NCT00519285|Primary|Overall Survival Time|"Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause.~The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the Intent-to-treat (ITT) population (i.e all randomized participants according to the treatment assigned regardless of the drug actually received).~At the cut-off date, 873 deaths had occurred, 445 in the Placebo group and 428 in the Aflibercept group."|||months||95% Confidence Interval|Median
1248926|NCT00519194|Primary|Freedom From Atrial Fibrillation in the Absence of Any AF Therapies|Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.|6 months||||participants|||Number
1248927|NCT00519090|Secondary|Durable Complete Cytogenetic Response Rate|Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.|24 months|The trial was terminated early, so only 6 patients were enrolled.|||percent of participants|||Number
1248930|NCT00519077|Primary|Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates|"The proportion of subjects that responded [complete (CR) or partial response (PR)], had stable disease (SD), or progressive disease (PD) as defined by the Response Evaluation Criteria In Solid Tumors (RECIST)~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|8 weeks|Eight patients were not assessable for response, six of them died prior to the evaluation of response. For the purpose of the analysis these patients were classified as having disease progression in response to therapy.|||percentage of participants|||Number
1248931|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of Sleepiness."|Baseline and 12 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248932|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of Sleepiness."|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248933|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of Sleepiness."|Baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at Baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248934|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of Sleepiness."|Baseline and 2 weeks|Full analysis set defined as subjects who completed the ES Symptom Rating form at baseline and 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248935|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)|"The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of Sleepiness."|Baseline and Endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects with at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1248936|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks."|baseline and 12 weeks following start of study drug administration|Full analysis set defined as subjects who completed MOS-CF6 at baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248937|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks."|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at week 8|||Units on a scale||Standard Error|Least Squares Mean
1248938|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks."|baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248939|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks."|baseline and 2 weeks|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248940|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline)."|Baseline and Endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1248941|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.|12 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 12 weeks|||Participants|||Number
1248942|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.|8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 8 weeks|||Participants|||Number
1248943|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.|4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 4 weeks|||Participants|||Number
1248944|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.|2 weeks following start of study drug administration|Full analysis set defined as subject who completed the FOSQ at 2 weeks|||Participants|||Number
1248945|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.|Endpoint (week 12 or last observation after baseline)|Full analysis set defined as subjects with at least one observation after baseline|||Participants|||Number
1248946|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.|baseline and 12 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
1249369|NCT00517075|Secondary|Theory of Mind||At baseline and the end of each study phase (random and open)|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1248947|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248948|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.|baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248949|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.|baseline and 2 weeks following start of study drug administration|Full analysis set defined as subjects who completed FOSQ at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248950|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.|Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1248951|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 12 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248952|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248953|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248954|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248963|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248955|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and at endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1248956|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.|12 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at 12 weeks|||Participants|||Number
1248957|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.|8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at 8 weeks|||Participants|||Number
1248958|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.|4 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at 4 weeks|||Participants|||Number
1248959|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.|2 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at 2 weeks|||Participants|||Number
1248960|NCT00518986|Secondary|Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.|12 weeks after start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline|||Participants|||Number
1248961|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.|12 weeks||||Units on a scale||Standard Error|Least Squares Mean
1248962|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at week 8|||Units on a scale||Standard Error|Least Squares Mean
1248973|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.|4 weeks|Full analysis set defined as number of subjects who completed ESS at 4 weeks|||Participants|||Number
1248964|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248965|NCT00518986|Secondary|Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).|Baseline and 12 weeks or last observation after baseline|Full analysis set defined as subjects with at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1248966|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.|Baseline and 12 weeks after start of study drug administration||||Units on a scale||Standard Error|Least Squares Mean
1248967|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.|Baseline and 8 weeks after start of study drug administration||||Units on a scale||Standard Error|Least Squares Mean
1248968|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who had completed BFI at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248969|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who had completed BFI at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248970|NCT00518986|Secondary|Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.|Baseline and 12 weeks following start of study drug administration or last recorded observation|Full analysis set defined as subjects with at least one BFI assessment after baseline|||Units on a scale||Standard Error|Least Squares Mean
1248971|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.|12 weeks|Full analysis set defined as subjects who completed the ESS at 12 weeks|||Participants|||Number
1248972|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.|8 weeks|Full analysis set defined as subjects who completed ESS at 8 weeks|||Participants|||Number
1249370|NCT00517075|Secondary|Depression||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1248974|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.|2 weeks|Full analysis set defined as the number of subjects who completed the ESS at 2 weeks|||Participants|||Number
1248975|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized.|12 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed ESS at Baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248976|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed ESS at Baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
1248977|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed ESS at baseline and at Week 4|||Units on a scale||Standard Error|Least Squares Mean
1248978|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized.|Baseline and 2 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ESS at baseline and at 2 weeks|||Unit on a scale||Standard Error|Least Squares Mean
1248979|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.|12 weeks after starting study drug treatment|Full analysis set defined as subjects assessed by CGI-C at 12 weeks|||Participants|||Number
1248980|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.|8 weeks after start of study drug treatment|Full analysis set defined as subjects who were assessed by CGI-C at 8 weeks|||Participants|||Number
1248981|NCT00518986|Secondary|Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.|4 weeks after start of treatment|Full analysis set defined as subjects who were assessed by CGI-C at 4 weeks.|||Participants|||Number
1248982|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 12 Weeks|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.|12 weeks after beginning treatment|Full analysis set defined as subjects assessed with CGI-C at week 12|||Participants|||Number
1248983|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 8 Weeks|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed."|8 weeks after beginning study drug treatment|Full analysis set defined as subjects assessed by CGI-C at 8 weeks|||Participants|||Number
1249371|NCT00517075|Secondary|Social Functioning||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1248984|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 4 Weeks|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed."|4 weeks after beginning study drug treatment|Full analysis set defined as subjects who were assessed with CGI-C at 4 weeks|||Participants|||Number
1248985|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|baseline and 12 weeks (or last observation after baseline)|Full analysis set defined as subjects who had measurements of MWT at baseline and 12 weeks.|||Minutes||Standard Error|Least Squares Mean
1248986|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|Baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects with MWT measure at 8 weeks and baseline|||Minutes||Standard Error|Least Squares Mean
1248987|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|baseline and 4 weeks|Full analysis set defined as subjects who had MWT measurement at baseline and at 4 weeks|||Minutes||Standard Error|Least Squares Mean
1248988|NCT00518986|Secondary|Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)|For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.|Baseline and 12 weeks (or last observation after baseline)|Full analysis set defined as subjects who had at least one assessment of ESS after baseline|||Units on a scale||Standard Error|Least Squares Mean
1248989|NCT00518986|Primary|Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) were assessed."|12 weeks (or last observation after baseline)|Full analysis set which includes subjects who had at least 1 measurement of MWT or CGI-C after baseline.|||Participants|||Number
1248990|NCT00518986|Primary|Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.|Baseline and 12 weeks (or last observation after baseline)|Full analysis set which includes subjects who had at least 1 measurement of MWT or Clinical Global Impression of Change (CGI-C) after baseline.|||Minutes||Standard Deviation|Mean
1248991|NCT00518882|Secondary|Hypoglyceamic Episodes, Weeks 26-78|Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 26-78|The safety analysis set is all subjects who had been exposed to at least one dose of the study products.|||episodes|||Number
1248992|NCT00518882|Secondary|Hypoglycaemic Episodes at Week 26|Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|The safety analysis set is all subjects who had been exposed to at least one dose of the study products.|||episodes|||Number
1249372|NCT00517075|Secondary|Global Clinical Improvement||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1248993|NCT00518882|Secondary|Change in Apolipoprotein B at Week 78|Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||g/L||Standard Deviation|Mean
1248994|NCT00518882|Secondary|Change in Apolipoprotein B, Weeks 26-78|Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||g/L||Standard Deviation|Mean
1248995|NCT00518882|Secondary|Change in Apolipoprotein B at Week 26|Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||g/L||Standard Error|Least Squares Mean
1248996|NCT00518882|Secondary|Change in Free Fatty Acid at Week 78|Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1248997|NCT00518882|Secondary|Change in Free Fatty Acid, Weeks 26-78|Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1248998|NCT00518882|Secondary|Change in Free Fatty Acid at Week 26|Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1248999|NCT00518882|Secondary|Change in Triglyceride at Week 78|Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249000|NCT00518882|Secondary|Change in Triglyceride, Weeks 26-78|Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249001|NCT00518882|Secondary|Change in Triglyceride at Week 26|Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249002|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol at Week 78|Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249003|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol, Weeks 26-78|Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249004|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol at Week 26|Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249005|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol at Week 78|Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249006|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78|Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249007|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol at Week 26|Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249008|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol at Week 78|Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249009|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol, Weeks 26-78|Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249010|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol at Week 26|Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249011|NCT00518882|Secondary|Change in Total Cholesterol at Week 78|Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
1249012|NCT00518882|Secondary|Change in Total Cholesterol, Weeks 26-78|Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Deviation|Mean
1249013|NCT00518882|Secondary|Change in Total Cholesterol at Week 26|Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249014|NCT00518882|Secondary|Change in Beta-cell Function at Week 78|"Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage point (%point)||Standard Deviation|Mean
1249015|NCT00518882|Secondary|Change in Beta-cell Function, Weeks 26-78|"Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage point (%point)||Standard Deviation|Mean
1249016|NCT00518882|Secondary|Change in Beta-cell Function at Week 26|"Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||percentage point (%point)||Standard Error|Least Squares Mean
1249017|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78|Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249018|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78|Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249019|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78|Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249373|NCT00517075|Primary|Clinical Improvement of Negative Symptoms (Positive and Negative Syndrome Scale [PANSS] Negative Symptoms Subscale) Relative to Pre-treatment Baseline.||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1249020|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78|Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249021|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78|Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249022|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78|Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249023|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26|Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249024|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26|Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0. week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249025|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26|Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249026|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78|Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249027|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78|Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249028|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78|Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249029|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78|Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249030|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78|Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249031|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78|Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249032|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26|Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249033|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26|Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249034|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26|Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249035|NCT00518882|Secondary|Change in Fasting Plasma Glucose at Week 78|Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249036|NCT00518882|Secondary|Change in Fasting Plasma Glucose, Weeks 26-78|Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
1249037|NCT00518882|Secondary|Change in Fasting Plasma Glucose at Week 26|Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
1249038|NCT00518882|Secondary|Change in Body Weight at Week 78|Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||kg||Standard Deviation|Mean
1249039|NCT00518882|Secondary|Change in Body Weight, Weeks 26-78|Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||kg||Standard Deviation|Mean
1249040|NCT00518882|Secondary|Change in Body Weight at Week 26|Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||kg||Standard Error|Least Squares Mean
1249041|NCT00518882|Secondary|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78|Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage (%) of subjects|||Number
1249042|NCT00518882|Secondary|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26|Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||percentage (%) of subjects|||Number
1249043|NCT00518882|Secondary|Change in Glycosylated A1c (HbA1c) at Week 78|Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage point of total HbA1c||Standard Deviation|Mean
1249044|NCT00518882|Secondary|Change in Glycosylated A1c (HbA1c), Weeks 26-78|Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage point of total HbA1c||Standard Deviation|Mean
1249045|NCT00518882|Primary|Change in Glycosylated A1c (HbA1c) at Week 26|Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||percentage point of total HbA1c||Standard Error|Least Squares Mean
1249078|NCT00518531|Secondary|Persistence With Treatment in the First Treatment Period|Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.|Treatment period 1 (Month 1 to Month 12)|Full analysis set|||Participants|||Number
1249046|NCT00518713|Other Pre-specified|Percent Reduction of Total (Drop and Non-Drop) Seizures.|This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition.|4-week baseline period and 12-week maintenance period||||Percent reduction||Full Range|Least Squares Mean
1249047|NCT00518713|Other Pre-specified|Percent Reduction in the Number of Non-drop Seizures.|This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell.|4-week baseline period and the 12-week maintenance period||||Percent reduction||Full Range|Least Squares Mean
1249048|NCT00518713|Secondary|Parent/Caregiver Global Evaluations of the Patient’s Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 15|Those patients in the MITT population who had a baseline and Week 15 parent/caregiver global evaluations were analyzed.|||participants|||Number
1249049|NCT00518713|Secondary|Investigator Global Evaluations of the Patient's Overall Change in Symptoms.|"The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 15|Those patients in the MITT population who completed a Physician Global Evaluation at Week 15.|||participants|||Number
1249050|NCT00518713|Secondary|Tolerance|Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period.|4-week baseline period and first 4/first 8 weeks of the maintenance period|MITT|||Participants|||Number
1249051|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the last 4 weeks of the 12-week maintenance period||||Percent Responders|||Number
1249052|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the middle 4 weeks of the 12-week maintenance period||||Percent Responders|||Number
1249053|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the first 4 weeks of the 12-week maintenance period|MITT|||Percent of responders|||Number
1249054|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the 12-week maintenance period||||Percent of responders|||Number
1249055|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the last 4 weeks of the 12-week maintenance period||||Percent reduction||Full Range|Least Squares Mean
1249056|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the middle 4 weeks of the 12-week maintenance period||||Percent reduction||Full Range|Least Squares Mean
1249057|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the first 4 weeks of the 12-week maintenance period|MITT population|||Percent reduction||Full Range|Least Squares Mean
1249058|NCT00518713|Primary|Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 12-week maintenance period|Modified Intent-to-Treat (MITT) population|||Percent Reduction||Full Range|Least Squares Mean
1249847|NCT00513500|Primary|Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)||one year|The participants analyzed was based on children reported with fever. Analysis was per intention to treat.|||participants|||Number
1249059|NCT00518687|Secondary|Number of Participants With Surgical-site Staphylococcus Aureus Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination|||participants|||Number
1249060|NCT00518687|Secondary|Number of Participants With Invasive Staphylococcus Aureus Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination|||participants|||Number
1249061|NCT00518687|Primary|Incidence Rate of Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.|Up to 360 days after surgery|The population analyzed included all vaccinated participants with follow-up results|||Events per 100 person-years|||Number
1249062|NCT00518687|Primary|Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination|||participants|||Number
1249063|NCT00518622|Primary|Antiviral Activity of MK7009|Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8|Baseline and Day 8|Per-protocol population (defined as the study participants that completed the study as defined by the protocol). One participant was excluded from the analysis due to incorrect dosing of study medication.|||Log10 IU/mL HCV RNA||Standard Deviation|Mean
1249064|NCT00518622|Primary|Safety and Tolerability of MK7009|Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication|14 days after completion of study therapy|All treated patients are included in the safety analysis.|||Participants|||Number
1249065|NCT00518531|Secondary|Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period|The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.|Month 18, Month 24 (treatment period 2)|"Participants in the PRO analysis set with at least one post-baseline assessment in both periods and with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
1249066|NCT00518531|Secondary|Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period|The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.|Month 6, Month 12 (treatment period 1)|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
1249067|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ) Preference Score|The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. The BMQ preference score, which measures a participant's overall evaluation of a medication, is based on the average of 7 items in the BMQ. The preference score ranges from 1 to 5, with higher scores indicating stronger preference for one medication over the other.|Baseline and Month 6, Month 12, Month 18, and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
1249079|NCT00518531|Secondary|Compliance With Treatment in the Second Treatment Period|Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).|Treatment period 2 (Month 13 to Month 24)|Crossover set|||Participants|||Number
1250705|NCT00506662|Secondary|Change in Glycosylated Haemoglobin (HbA1c) at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1249068|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ) Concern Score|The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. Participants' concern about the adverse consequences of taking the medication for controlling osteoporosis was based on the average of 10 items from the BMQ that form the concern score. The concern score ranges from 1 to 5, with higher scores indicating stronger concerns about the adverse consequences of taking the prescribed medication for controlling osteoporosis.|Baseline and Month 6, Month 12, Month 18, and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
1249069|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ): Necessity Score|"The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other.~Participants' beliefs about the necessity of the prescribed medication to treat osteoporosis were based on the average of 5 items from the BMQ that form the necessity score. The necessity score ranges from 1 to 5, with higher scores indicating stronger beliefs about the necessity of the prescribed medication for controlling osteoporosis."|Baseline, Month 6, Month 12, Month 18 and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
1249070|NCT00518531|Secondary|Overall Satisfaction to Study Treatment|"Participant satisfaction with their treatment was assessed using question 7 (ie, “Please rate your satisfaction with the weekly pill on the following: frequency of administration; mode of administration [taking a pill]; convenience; overall satisfaction”) and question 8 (ie, “Please rate your satisfaction with the six month injection on the following: frequency of administration; mode of administration [receiving an injection]; convenience; overall satisfaction”) from the Preference Satisfaction Questionnaire (PSQ) at the end of each treatment period. The PSQ is a 34 item, self-report questionnaire of participants’ preference and satisfaction for each of the two study treatments. Possible answers include: Not at all Satisfied, A Little Satisfied, Moderately Satisfied, Quite Satisfied, and Very Satisfied."|End of treatment period 1 (Month 12)|The Patient Reported Outcomes (PRO) analysis set for each independent treatment period included patients in the FAS who received at least one dose of study drug and had at least one post-baseline assessment in the relevant treatment period. Analysis population includes patients with observed data for ≥1 question in the questionnaire.|||Participants|||Number
1249071|NCT00518531|Secondary|Time to Non-persistence to Alendronate Treatment in the Second Treatment Period|Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.|Treatment period 2 (Month 13 to Month 24)|Crossover set|||weeks||Standard Error|Mean
1249072|NCT00518531|Secondary|Time to Non-persistence to Alendronate Treatment in the First Treatment Period|Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.|Treatment period 1 (Month 1 to Month 12)|Full analysis set|||weeks||Standard Error|Mean
1249073|NCT00518531|Secondary|Time to Non-compliance to Alendronate Treatment in the Second Treatment Period|Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.|Treatment period 2 (Month 13 to Month 24)|crossover set|||weeks||Standard Error|Mean
1249074|NCT00518531|Secondary|Time to Non-compliance to Alendronate Treatment in the First Treatment Period|Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.|Treatment period 1 (Month 1 to Month 12)|Full analysis set|||weeks||Standard Error|Mean
1249075|NCT00518531|Secondary|Time to Non-adherence to Alendronate Treatment in the Second Treatment Period|Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.|Treatment Period 2 (Month 13 to Month 24)|Crossover set|||weeks||Standard Error|Mean
1249076|NCT00518531|Secondary|Time to Non-adherence to Alendronate Treatment in the First Treatment Period|Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.|Treatment Period 1 (Month 1 to Month 12)|Full analysis set|||weeks||Standard Error|Mean
1249077|NCT00518531|Secondary|Persistence With Treatment in the Second Treatment Period|Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.|Treatment period 2 (Month 13 to Month 24)|Crossover set|||Participants|||Number
1249374|NCT00517010|Secondary|1. Change in BCVA From Baseline|change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline|24 months||||change in number of letters||Standard Deviation|Mean
1249080|NCT00518531|Secondary|Compliance With Treatment in the First Treatment Period|Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).|Treatment period 1 (Month 1 to Month 12)|Full analysis set|||Participants|||Number
1249081|NCT00518531|Secondary|Adherence With Treatment in the Second Treatment Period|A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed nonadherent to treatment.|Treatment period 2 (Months 13 to 24)|The cross-over analysis set includes all participants who crossed over to their treatment period 2 treatment.|||Participants|||Number
1249082|NCT00518531|Primary|Adherence With Treatment in the First Treatment Period|A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment.|Treatment period 1 (Month 1 to Month 12)|The full analysis set (FAS) includes all participants who were randomized.|||Participants|||Number
1249083|NCT00518349|Primary|Patient Assessment of Pain Experienced During Colonoscopy|"The proportion of patients reporting no pain when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet)."|Pain experienced during colonoscopy|Power estimates based on assumption of 20% difference in pain-free examination comparing groups|||participants|||Number
1249084|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249085|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249086|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249087|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249088|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249105|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249089|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249090|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249091|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249092|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249093|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249094|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249095|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249096|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249106|NCT00518336|Secondary|Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1250706|NCT00506662|Primary|Change in Glycosylated Haemoglobin (HbA1c) at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1249097|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249098|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249099|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249100|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249101|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249102|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249103|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249104|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249375|NCT00517010|Primary|Incidence and Severity of Ocular Adverse Events|Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.|24 months||||number of adverse events|||Number
1249107|NCT00518336|Secondary|Number of Subjects With Medically Signifant Conditions up to Year 9|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249108|NCT00518336|Secondary|Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.||Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249109|NCT00518336|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9|NOCDs include for example asthma, type I diabetes, allergies, ...|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo).|||Subjects|||Number
1249110|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Month 77 until year 9 (Month 113)|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.|||Titer||95% Confidence Interval|Geometric Mean
1249111|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked immunosorbent assay (ELISA) Units per milliliter (EL.U/mL).~The cut-off-vales assessed were >= 8 or 7 EL. U/mL for anti-HPV-16 and 18, respectively."|At Month 77 until year 9 (Month 113)|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.|||EL. U/mL||95% Confidence Interval|Geometric Mean
1249112|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249113|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249114|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249115|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249116|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249117|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study"|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249118|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249119|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249120|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249121|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249122|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249123|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"Cervical Intraepithelial Neoplasia (CIN1)+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
1249124|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249125|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249163|NCT00518323|Secondary|Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness|The sleep VAS for daytime drowsiness is a scale for measuring the drowsiness experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Standard Deviation|Mean
1249126|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249127|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249128|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249129|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study, who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249130|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249131|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249132|NCT00518336|Secondary|Number of Subjects With SAEs up to Year 8|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249133|NCT00518336|Secondary|Number of Subjects With Serious Adverse Events (SAEs) up to Year 7|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249134|NCT00518336|Secondary|Number of Subjects With Medically Significant Conditions up to Year 8|"Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Medically significant conditions which were not unblinded at the time of the analysis are not presented yet."|up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249135|NCT00518336|Secondary|Number of Subjects With Medically Significant Conditions up to Year 7|"Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Medically significant conditions which were not unblinded at the time of the analysis are not presented yet."|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249136|NCT00518336|Secondary|Number of Subjects With NOAD up to Year 8|The values of NOADs are not yet corresponding to the values in each group. The cases are still blinded. They will be disclosed as soon as the results will be available.|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249137|NCT00518336|Secondary|Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7||Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249138|NCT00518336|Secondary|Number of Subjects With NOCD up to Year 8|"NOCDs included for example asthma, type I diabetes, allergies, ...~NOCDs which were not unblinded at the subject level at the time of the analysis are not presented and will be disclosed as soon as they become available."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249139|NCT00518336|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7|NOCDs include for example asthma, type I diabetes, allergies, ...|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249140|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Months 77-101|The analyses were performed on a subset of the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1249141|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort|Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).|At Months 77-101|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1249142|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249143|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249144|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249145|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249146|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249147|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249148|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249149|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249150|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249151|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249152|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249153|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN (Cervical Intraepithelial Neoplasia) grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
1249154|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
1249164|NCT00518323|Secondary|Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.|The sleep VAS for sleep quality is a scale for measuring the quality of sleep experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Standard Deviation|Mean
1249155|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
1249156|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
1249157|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
1249158|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
1249159|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
1249160|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
1249161|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
1249162|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.|Up to year 8|According-To-Protocol (ATP) cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
1249268|NCT00517829|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Treatment will continue until disease progression or intolerable toxicity.|Evaluable Population|||percentage of participants||95% Confidence Interval|Number
1249165|NCT00518323|Secondary|Change From Baseline to End Point in Children's Global Assessment (CGAS) Score|The CGAS score assesses psychological, social, and school functioning for children 6 to 17 years of age. Scores range from 1 to 100, where 100=best and 1=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Standard Deviation|Mean
1249166|NCT00518323|Secondary|Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S rating scale was used to assess the severity of a subject’s overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Full Range|Median
1249167|NCT00518323|Primary|Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study.|The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to the end.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Standard Deviation|Mean
1249168|NCT00518284|Secondary|Diameter Stenosis|Diameter stenosis is calculated as [1 - (minimum lumen diameter (MLD) / reference vessel diameter)] * 100, where the reference vessel diameter is the vessel diameter measured in a healthy segment of the target vessel proximal as close as possible to the lesion.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percent diameter stenosis||Standard Deviation|Mean
1249169|NCT00518284|Secondary|Percentage of Participants With Binary Restenosis|Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
1249170|NCT00518284|Secondary|Late Loss|Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.|Day 1 (following revascularization) and 9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||mm||Standard Deviation|Mean
1249171|NCT00518284|Secondary|Minimum Lumen Diameter|Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||mm||Standard Deviation|Mean
1249172|NCT00518284|Secondary|Number of Participants With a Stroke|The number of patients experiencing a stroke during the study. Stroke was defined as any sudden development of neurological deficits lasting more than 24 hours, and if a brain imaging study is performed it shows an infarction or hemorrhage. A transient ischemic attack is a neurological deficit lasting less than 24 hours and, if an imaging study is performed, shows no evidence of infarction or hemorrhage.|Up to 11 months|Treated population.|||participants|||Number
1249173|NCT00518284|Secondary|Number of Participants With Myocardial Infarction (MI)|The number of patients experiencing Myocardial Infarction (MI) during the study. Myocardial Infarction was defined as new pathologic Q waves of at least 0.04 seconds, or an increase in serum creatine kinase to more than twice the normal code together with a pathologic increase in myocardial isoenzymes.|Up to 11 months|Treated population.|||participants|||Number
1249174|NCT00518284|Secondary|Number of Deaths|Number of patients who died due to any cause.|Up to 11 months|Treated population.|||participants|||Number
1249175|NCT00518284|Secondary|Target Lesion Revascularization (TLR) at 9 Months|Target lesion revascularization (TLR) was defined as repeat percutaneous intervention or bypass surgery of the previously treated target lesion (or blockage). The percentage of participants requiring revascularization of the target lesion was determined by stenosis of > 50% confirmed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
1249176|NCT00518284|Secondary|Decrease in Ankle Brachial Index (ABI) > 0.15|"The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15.~Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure."|Baseline and Month 9|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
1249177|NCT00518284|Secondary|Change From Baseline in Walking Impairment Questionnaire (WIQ) Score|The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient’s walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty).|Baseline and Month 9|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||scores on a scale||Standard Deviation|Mean
1249178|NCT00518284|Secondary|Systolic Velocity Ratio (SVR) > 2.0|The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
1249179|NCT00518284|Primary|Target Vessel Revascularization at 9 Months|Target vessel revascularization (TVR) was defined as percutaneous revascularization or bypass of the target lesion or any segment of the artery containing the target lesion. The percentage of participants requiring revascularization of the target vessel was determined by stenosis of > 50% confirmed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
1249269|NCT00517829|Secondary|Overall Survival|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|Treatment will continue until disease progression or intolerable toxicity|ITT population|||months||95% Confidence Interval|Median
1249180|NCT00518206|Secondary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity was defined as any treatment-related grade 4 toxicity or any grade 3 toxicity, excluding grade 3 skin necrosis at the site of the delayed-type hypersensitivity reaction, fever, or asymptomatic hyperglycemia that improved to baseline within 3 weeks of onset.|Up to 22 months|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||participants|||Number
1249181|NCT00518206|Secondary|Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine|Blood samples were drawn to measure humoral immunologic response at pretreatment and weeks 3, 7, 11, 33, and every 12 weeks thereafter. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 by enzyme-linked immunosorbent assay (ELISA). Data are presented according to baseline (BL) NY-ESO-1 antibody positivity and the time to seroconversion, if applicable.|Up to 22 months|Subjects with available measurement of baseline and post-baseline positivity for NY-ESO-1 antibodies.|||Participants|||Count of Participants
1249182|NCT00518206|Secondary|Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions|NY-ESO-1-specific DTH was measured by intradermal injection with the full-length NY-ESO-1 protein, NY-ESO-1b peptide, and NY-ESO-1 DP4 peptide at pretreatment, week 11, and between week 23 and 25. DTH reactions (eg, local skin irritation) were evaluated 2 days after DTH injections. Data presented are based on injections with the full-length peptide, as these data are considered to be representative of the comprehensive DTH results.|Up to 22 months|Subjects who underwent DTH testing with available DTH reaction evaluation(s).|||Participants|||Count of Participants
1249183|NCT00518206|Secondary|Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine|Blood samples were drawn to measure cellular response at pretreatment and weeks 3, 7, 11, between weeks 23 and 25, week 33, and every 12 weeks thereafter. Cellular immunity included an assay for gamma interferon-producing T cells and enumeration of NY-ESO-1b-specific T cells, detected by fluorescent labeled human leukocyte antigen (HLA)-A2 tetramers carrying the NY-ESO-1b peptide, expressed as percent positive staining of CD4+ and CD8+ T cells. Data are presented for CD4+ and CD8+ T-cell responses (not mutually exclusive) that were pre-existing at baseline (BL) or presented at any time post-BL.|Up to 22 months|Subjects with available results from the evaluation of T-cell responses in peripheral blood.|||participants|||Number
1249184|NCT00518206|Primary|Number of Subjects With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and categorized according to RECIST (version 1.0) at baseline, at week 11, between weeks 23 and 25, and every 12 weeks thereafter. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 22 months|Subjects with data available from at least 1 post-baseline response assessment.|||Participants|||Count of Participants
1249185|NCT00518180|Secondary|Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination|Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.|Days 1 to 7|The analysis was performed on the safety population.|||Subjects|||Number
1249186|NCT00518180|Secondary|Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.|Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.|Days 1 to 7|The analysis was performed on the safety set.|||Subjects|||Number
1249187|NCT00518180|Primary|Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)|To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||IU/mL||95% Confidence Interval|Geometric Mean
1249188|NCT00518180|Secondary|Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN|To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
1249189|NCT00518180|Secondary|Geometric Mean Titers (GMT) of Pertussis Antigens|To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1249190|NCT00518180|Secondary|Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus|To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||IU/mL||95% Confidence Interval|Geometric Mean
1249191|NCT00518180|Secondary|The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus|The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
1249192|NCT00518180|Secondary|Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups|The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
1249193|NCT00518180|Secondary|Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay|To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)|1 month post third HPV vaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1249194|NCT00518180|Secondary|Percentage of Subjects With Anti-HPV Seroconversion|To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.|1 month post third HPV vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
1249195|NCT00518180|Secondary|Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups|The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1249196|NCT00518180|Primary|Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL|To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population. A total of 183 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.|||Percentage of subjects||95% Confidence Interval|Number
1249197|NCT00518180|Primary|Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse|"Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.~Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population. A total of 182 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.|||Percentage of participants||95% Confidence Interval|Number
1249198|NCT00518115|Secondary|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG|EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK/PD Analysis Population: all participants in the PK Analysis Population with sufficient dosing history for inclusion in the PK/PD analysis|||nanograms per milliliter||95% Confidence Interval|Mean
1249199|NCT00518115|Secondary|Mean Absorption Rate of Albiglutide|Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population|||hour^-1||95% Confidence Interval|Mean
1249200|NCT00518115|Secondary|Mean Volume of Distribution of Albiglutide|Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population|||Liters||95% Confidence Interval|Mean
1249201|NCT00518115|Secondary|Mean Clearance of Albiglutide|Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population: all participants for whom a PK sample was obtained and analyzed|||milliliters per hour||95% Confidence Interval|Mean
1249202|NCT00518115|Secondary|Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16|"The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, In the past week I was hungry; Q2, In the past week I thought about food; Q3, In the past week I wanted to eat; Q4, In the past week I ate more than I should have; Q5, In the past week, I craved specific food; Q6, In the past week when finished meals I felt full; Q7, In the past week when finished meals I felt satisfied."|Week 16|Safety Population. Only those participants available at the specified time point were analyzed.|||Participants|||Number
1249222|NCT00518011|Secondary|Mean Change in Blood Pressure From Baseline|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at Baseline.|||mm Hg||Standard Deviation|Mean
1249376|NCT00516919|Primary|Participant BMI|Body Mass Index (BMI)|4 months and 6 month follow-up|Data for all randomized participants were included. In the event of dropout or missing data, baseline values were used.|||kg/m^2||Standard Deviation|Mean
1249203|NCT00518115|Secondary|Change From Baseline in Functional Living Index – Emesis (FLIE) Scores at Week 16|The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.|Baseline and Week 16|Safety Population: all randomly assigned participants who received at least one dose of study drug. Only those participants available at the specified time point were analyzed. Change from Baseline was calculated as the score at Week 16 minus the score at Baseline.|||Score on a scale||Standard Deviation|Mean
1249204|NCT00518115|Secondary|Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16|Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||mmol/L||Standard Deviation|Mean
1249205|NCT00518115|Secondary|Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16|Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Picomoles per liter (pmol/L)||Standard Deviation|Mean
1249206|NCT00518115|Secondary|Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16|Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Nanograms per liter (ng/L)||Standard Deviation|Mean
1249207|NCT00518115|Secondary|Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16|Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Nanomoles per liter (nmol/L)||Standard Deviation|Mean
1249223|NCT00518011|Secondary|Mean Change in Pulse Rate From Baseline|Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at baseline.|||beats per minute||Standard Deviation|Mean
1249377|NCT00516906|Secondary|Rating of Skin Condition|Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)|Daily up to 7 Days (average 3-7 days of wear)||||Units on a scale||Standard Deviation|Mean
1249208|NCT00518115|Secondary|Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16|Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1249209|NCT00518115|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1249210|NCT00518115|Secondary|Percent Change From Baseline in Body Weight at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the ([value at Week 16 minus the Baseline value] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.|||Percent change||Standard Deviation|Mean
1249211|NCT00518115|Secondary|Change From Baseline in Body Weight at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.|||Kilograms (Kg)||Standard Deviation|Mean
1249212|NCT00518115|Secondary|Change From Baseline in Waist Circumference at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.|||Centimeters||Standard Deviation|Mean
1249213|NCT00518115|Secondary|Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|The number of participants who achieved target values for HbA1c (i.e., HbA1c <6.5% and >=6.5% to <7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1249224|NCT00518011|Secondary|Overall Survival|Overall survival was defined as the interval between the date of randomization to the date of death from any cause.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death|||Week||95% Confidence Interval|Median
1249225|NCT00518011|Secondary|Duration of Response|Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.|Up to 2 years|PP population included all randomized participants received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. Participants available at the time of evaluation of duration of response were included in the analysis.|||Week||Standard Deviation|Mean
1249214|NCT00518115|Secondary|Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1249215|NCT00518115|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|Intent-to-Treat (ITT) Population: all randomly assigned participants with at least one post-Baseline assessment of the primary endpoint. Participants from the exenatide arm were not included in the analysis. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1249216|NCT00518089|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
1249217|NCT00518089|Secondary|Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6|Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis.|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
1249218|NCT00518089|Secondary|Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6|Percentage of patients with clinical improvement of ocular signs up to Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus), with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
1249219|NCT00518089|Secondary|Percentage of Patients With Microbiological Cure Up to Day 6|Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated up to Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
1249220|NCT00518089|Secondary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
1249221|NCT00518011|Secondary|Mean Change in Body Temperature From Baseline|Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose/infusion and had at least one safety assessment performed at baseline.|||Fahrenheit||Standard Deviation|Mean
1249226|NCT00518011|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.|||Percentage of participants|||Number
1249227|NCT00518011|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.|||Percentage of participants|||Number
1249228|NCT00518011|Primary|Progression Free Survival|Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|Up to 2 years|Per protocol (PP) population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.|||Week||95% Confidence Interval|Median
1249229|NCT00517933|Secondary|Short Form Health Survey (SF36) Aggregate Physical|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Mean raw scores of SF36 Aggregate Physical."|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249230|NCT00517933|Secondary|Change in SF36 Aggregate Physical (Adjusted Value)|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1249231|NCT00517933|Secondary|Short Form Health Survey (SF36) General Health|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Mean raw scores of SF36 General Health"|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249232|NCT00517933|Secondary|Change in Short Form Health Survey (SF36) General Health - Adjusted Value|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1249233|NCT00517933|Secondary|EuroQOL (EQ-5D) Utility|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.~Mean raw scores of EuroQOL Utility."|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249234|NCT00517933|Secondary|Change in EuroQOL (EQ-5D) Utility - Adjusted Value|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1249235|NCT00517933|Secondary|EuroQOL Thermometer|"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.~Mean raw scores of EuroQOL Thermometer."|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249236|NCT00517933|Secondary|Change in EuroQOL Thermometer (Adjusted Value)|"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1249237|NCT00517933|Secondary|ICECAP-O|The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249378|NCT00516906|Secondary|Clinician Overall Satisfaction With Dressing|Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor|Daily up to 7 Days (average 3-7 days of wear)||||Units on a scale||Standard Deviation|Mean
1249238|NCT00517933|Secondary|Change in ICECAP-O Adjusted Value|"The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best).~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1249239|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Impacts Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249240|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Impacts Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1249241|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Activity Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249242|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Activity Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1249243|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Symptoms Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249244|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Symptoms Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
1249245|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Total Score)|Mean raw scores of the St. George’s Respiratory Questionnaire. The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249246|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Total Score) (Adjusted Values)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 week||||units on a scale||95% Confidence Interval|Mean
1249247|NCT00517933|Secondary|Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.|Baseline, 6 week, 12 week||||units on a scale||Standard Deviation|Mean
1249248|NCT00517933|Secondary|Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 week||||units on a scale||95% Confidence Interval|Mean
1249249|NCT00517933|Secondary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups|Baseline, Week 6, Week 12|ITT|||percentage of predicted (DLCO)||Standard Deviation|Mean
1249250|NCT00517933|Secondary|Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values|Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, Week 12|ITT|||percentage of predicted (DLCO)||95% Confidence Interval|Least Squares Mean
1249251|NCT00517933|Secondary|Forced Vital Capacity (FVC)|Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups|Baseline, Week 6, Week 12|ITT|||liters||Standard Deviation|Mean
1249252|NCT00517933|Secondary|Change in Forced Vital Capacity (FVC) Adjusted Values|Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, Week 12|ITT|||liters||95% Confidence Interval|Least Squares Mean
1249379|NCT00516906|Primary|Clinician Overall Satisfaction With Catheter Securement|Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor|Daily up to 7 Days (average 3-7 days of wear)||||Units on a scale||Standard Deviation|Mean
1249253|NCT00517933|Secondary|University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total|"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores)~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1249254|NCT00517933|Secondary|Change in Dyspnea|"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better."|Measured from enrollment to 12 weeks (phase I)||||units on a scale||95% Confidence Interval|Mean
1249255|NCT00517933|Secondary|Desaturation During 6-minute Walk Test (6MWT)|The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.|Week 12|ITT population|||percentage of participants||95% Confidence Interval|Number
1249256|NCT00517933|Secondary|Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, week 12||||meters||95% Confidence Interval|Mean
1249257|NCT00517933|Secondary|6-minute Walk Distance (6MWT)|The 6MWT measures the distance that a participant can walk in a period of 6 minutes.|Baseline, 6 week, 12 week||||meters||Standard Deviation|Mean
1249258|NCT00517933|Primary|Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)|This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Measured at Week 12||||participants|||Number
1249259|NCT00517881|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.|Week 0 up to Week 24|Safety population|||participants|||Number
1249260|NCT00517881|Secondary|Percentage of Participants With Red Blood Cell Transfusion During the Study|Percentage of participant who required red blood cell transfusion during the study was reported.|Week 0 up to Week 24|ITT Population|||percentage of participants|||Number
1249261|NCT00517881|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 up to Week 16 and Week 17 up to Week 24|ITT Population. Here, 'n' signifies the number of participants evaluable for specified category.|||percentage of participants|||Number
1249262|NCT00517881|Secondary|Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.|Week 17 up to Week 24|ITT Population|||days||Standard Deviation|Mean
1249263|NCT00517881|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP|Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.|Week 17 up to Week 24|ITT Population; data missing at the end of the EEP was handled using the last value carried forward method.|||percentage of participants||95% Confidence Interval|Number
1249264|NCT00517881|Secondary|Change in Hemoglobin Concentration Between Reference (SVP) and EEP|The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.|Week 17 up to Week 24|ITT population; data missing at the end of the EEP was handled using the last value carried forward method.|||g/dL||Standard Deviation|Mean
1249265|NCT00517881|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range|Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|The Intention-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (week 0) and for whom data for at least 1 follow-up variable was available. Data missing at the end of the EEP (that is, the last measured hemoglobin value before Week 24) was handled using the last value carried forward method.|||percentage of participants||95% Confidence Interval|Number
1249266|NCT00517829|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.|Treatment will continue until disease progression or intolerable toxicity|Patients who achieve a major objective response (CR or PR).|||months||95% Confidence Interval|Median
1249267|NCT00517829|Secondary|Time to Response|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|Treatment will continue until disease progression or intolerable toxicity|Patients who achieve a major objective response (CR or PR)|||months||95% Confidence Interval|Median
1249270|NCT00517829|Primary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Treatment will continue until disease progression or intolerable toxicity, up to 2 years|ITT population|||months||95% Confidence Interval|Median
1249271|NCT00517751|Other Pre-specified|Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery||Overall study period||||percentage of participants|||Number
1249272|NCT00517751|Other Pre-specified|Percent of Subjects Who Reported Implant-Related Adverse Events||Overall study period||||percentage of participants|||Number
1249273|NCT00517751|Secondary|Right Leg Pain in Numerical Rating Scales (NRS)|"Right leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249274|NCT00517751|Secondary|Left Leg Pain in Numerical Rating Scales (NRS)|"Left leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249275|NCT00517751|Secondary|Back Pain in Numerical Rating Scales (NRS)|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249276|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months|The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 60 months is reported.|60 months|At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.|||percentage of participants|||Number
1249277|NCT00517751|Secondary|General Health Status -- SF-36 MCS|MCS score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249278|NCT00517751|Secondary|General Health Status -- SF-36 PCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249279|NCT00517751|Secondary|Oswestry Disability Index (ODI) Score|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249280|NCT00517751|Secondary|Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment|Success rate in PS domain of ZCQ at post treatment is reported as the percentage of participants who had success in PS domain of ZCQ. The PS success was defined as PS score less than 2.5.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months||||percentage of participants|||Number
1249281|NCT00517751|Secondary|Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment|PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.|6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249282|NCT00517751|Secondary|Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)|Success rate in PF domain of ZCQ is reported as percentage of participants who had success in PF domain of ZCQ. The PF success was defined as clinically significant improvement by at least 0.5 points in PF score compared to preoperative baseline.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months||||percentage of participants|||Number
1249283|NCT00517751|Secondary|Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)|PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. If more than one item were missing, the PF score was considered as missing.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249284|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months|The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 24 months is reported.|24 months|At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.|||percentage of participants|||Number
1249285|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months|The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 60 months is reported.|60 months|At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.|||percentage of participants|||Number
1249318|NCT00517530|Primary|Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study|Dose-limiting toxicities were defined as obinutuzumab-related adverse events occurring within the first 28 days of each administration of obinutuzumab, with the exception of B-cell depletion and lymphopenia which are expected outcomes of treatment with obinutuzumab.|Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)|Safety population: All enrolled participants in Phase I, who had received at least 1 dose of obinutuzumab by 6 months.|||percentage of participants|||Number
1249286|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months|The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 24 months is reported.|24 months|At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.|||percentage of participants|||Number
1249287|NCT00517751|Secondary|Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)|Success rate in SS domain of ZCQ is reported as percentage of participants who had success in SS domain of the ZCQ. The SS success was defined as clinically significant improvement by at least 0.5 point in SS score compared to preoperative baseline.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months||||percentage of participants|||Number
1249288|NCT00517751|Secondary|Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. If more than two items were missing, the SS score was considered as missing.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
1249289|NCT00517751|Secondary|Treatment Success Rate at 60 Months|"Treatment success rate is reported as the percentage of participants who met all of the following criteria:~Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline~Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline~Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5~No additional surgery for lumbar stenosis performed~Maintenance of distraction~No dislodgement of the implant~No device-related complications"|60 months|At 60 months, 62 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.|||percentage of participants|||Number
1249290|NCT00517751|Primary|Treatment Success Rate at 24 Months|"Treatment success rate is reported as the percentage of participants who met all of the following criteria:~Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (ZCQ) compared to preoperative baseline~Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline~Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5~No additional surgery for lumbar stenosis performed~Maintenance of distraction~No dislodgement of the implant~No device-related complications"|24 months|At 24 months, 94 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.|||percentage of participants|||Number
1249291|NCT00517699|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time interval between the entry into trial and occurrence of one of the following events: progression of disease (PD) or death as a result of primary central nervous system lymphoma (PCNSL). Participants who were withdrawn from the study without documented progression and for whom there existed case report form (CRF) evidence that evaluations had been made, were censored at the date of last tumor assessment when participant was known to be progression free. Participants without postbaseline tumor assessments but known to be alive were censored at the time of randomization. PD required a ≥25% increase in the contrast-enhanced lesion seen on MRI as compared with baseline or best response (comparison should be made to the smallest of multiple lesions); progression of ocular disease as indicated by an increase in vitreous cell count or progressive retinal or optic nerve infiltration, appearance of any new lesion or site of disease during or at the end of therapy.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
1249292|NCT00517699|Secondary|Overall Survival|Time from entry into trial until death of any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the baseline date.|Time of last follow-up assessment between Day 1 and 3 years|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
1249293|NCT00517699|Secondary|Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse||Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
1249294|NCT00517699|Primary|Percentage of Participants With a CR, CRu or Partial Response (PR)|PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
1249328|NCT00517413|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.|Up to Week 52|The safety population included all participants who entered into the study.|||participants|||Number
1249536|NCT00515463|Secondary|Monocytes Change From Baseline at Month 1|Laboratory hematology monocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
1249295|NCT00517699|Primary|Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)|CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
1249296|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14|Amount of serum IL-5 measured from blood draws|0-6 hours post allergen challenge, 1 hour after dosing, Day 14|||||||
1249297|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35|Amount of serum interleukin (IL)-5 measured from blood draws|0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35|||||||
1249298|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14|Number of peripheral blood eosinophils measured from blood draws|0-6 hours, post allergen challenge, 1 hour post treatment, Day 14|ITT Population|||Giga Units per Liter (GI/L)||95% Confidence Interval|Mean
1249299|NCT00517634|Primary|Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35|Number of peripheral blood eosinophils measured from blood draws|0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35|Intent-to-Treat (ITT) Population: All participants receiving at least one dose of study medication who had at least one post-randomization efficacy assessment|||Giga Units per Liter (GI/L)||95% Confidence Interval|Mean
1249300|NCT00517595|Other Pre-specified|Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).|OS was measured from day 1 of treatment until time of death, assessed up to 20 months.|Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.|||Months||95% Confidence Interval|Median
1249301|NCT00517595|Other Pre-specified|Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. The median progression free survival is the parameter used to describe PFS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.|Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.|||Months||95% Confidence Interval|Median
1249302|NCT00517595|Secondary|Overall Response|Response was evaluated via changes from baseline in radiological tumor measurements performed after every 4th treatment cycle and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks.||||Participants|||Number
1249303|NCT00517595|Secondary|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|OS was measured from day 1 of treatment until time of death, assessed up to 20 months.||||Months||95% Confidence Interval|Median
1249304|NCT00517595|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.|TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months.||||Months||95% Confidence Interval|Median
1249305|NCT00517595|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.||||Months||95% Confidence Interval|Median
1249306|NCT00517556|Primary|Change in Visual Analog Scale (VAS) Score|Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain.|Baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
1249307|NCT00517530|Other Pre-specified|Maximum Plasma Concentration (Cmax) of Obinutuzumab in CLL Patients||at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)||||micrograms/mL||Geometric Coefficient of Variation|Geometric Mean
1249308|NCT00517530|Secondary|Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study|Blood samples were taken on Day 1 (pre-infusion, end of infusion, 3-6 hours post-infusion) of Cycle 1. Nonlinear mixed-effects modeling (with NONMEM software) was used to analyze the pooled samples for dose-concentration-time data of obinutuzumab.|Day 1 of Cycle 1|Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8.|||µm/ml*day||Geometric Coefficient of Variation|Geometric Mean
1249309|NCT00517530|Secondary|Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants|Obinutuzumab serum pharmacokinetic (PK) parameters in NHL participants following ascending doses.|at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)|Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants at any of the given time points). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8.|||µm/ml*day||Geometric Coefficient of Variation|Geometric Mean
1249310|NCT00517530|Secondary|Percentage of Retreated Participants With Response|Patients who might benefit from retreatment were allowed to be treated again at the request of the investigator.|by Cutoff Date: 25 November 2013 (within 4 years, 2 months)|Retreated participants|||percentage of participants|||Number
1249311|NCT00517530|Secondary|Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study|B-cell depletion was defined in two ways: definition 1 – decrease below 5% baseline level and definition 2 – decrease below 0.04 x 109/L. B-cell recovery was defined in two ways: definition 1 – return to at least 50% of baseline level and definition 2 – return to at least 0.08 x 109/L.|by the end of Phase II (within 3 years, 4 months)|Participants analyzed include those with B-cell depletion at the end of treatment (N), with assessments (n) at each time point.|||participants|||Number
1249312|NCT00517530|Secondary|Participants With Event-Free Survival (EFS) in Phase II of the Study|EFS is defined as the time from start of treatment to disease progression/relapse, death or, in case of early withdrawal from the treatment period, the (end) date of last dose, whatever comes first.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)||||participants|||Number
1249313|NCT00517530|Secondary|Duration of Response by Disease Type in Phase II of the Study|Duration of complete response was defined as the time from the first complete or partial response until disease progression (PD) or death, whichever occurred first. For non-Hodgkin’s lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is PET-positive with histological confirmation.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab. Data reported for each disease cohort.|||days||Full Range|Median
1249314|NCT00517530|Secondary|Progression-free Survival (PFS) in Phase II of the Study|PFS was defined as the time from start of treatment to disease progression (PD) or death due to any cause, whichever occurred first. For non-Hodgkin’s lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is positron emission tomography (PET)-positive with histological confirmation.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab.|||days||95% Confidence Interval|Median
1249315|NCT00517530|Secondary|Percentage of Participants With Partial Response (PR) in Phase II of the Study|A PR was defined as a >=50% decrease in SPD of the 6 largest nodes or nodal masses; no increase in size of other nodes, liver, or spleen; regression of splenic and hepatic nodules by >=50% in their SPD or, for single nodules, in the long axis (CLL only); and no new disease sites.|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)||||percentage of participants|||Number
1249316|NCT00517530|Secondary|Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study|A complete response was defined as the disappearance of all evidence of disease (NHL) and symptoms; normalization of biochemical abnormalities (NHL); regression of lymph nodes and nodal masses to normal size; decrease of nodes in the sum of the products of the greatest diameters (SPD); regression in size of the spleen and/or liver, should not be palpable, and disappearance of nodules related to lymphoma (CLL). Complete/unconfirmed (CRu) response includes NHL patients with one or more of the following: 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the SPD; 2) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). Complete Response with Incomplete Bone Marrow Recovery (CRi) was measured only in patients with CLL.|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)||||percentage of participants|||Number
1249317|NCT00517530|Primary|Percentage of Participants With Best Overall Response in Phase II of the Study|Best overall response (BOR) was defined as the percentage of participants with a complete response (CR) or partial response (PR)|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab.|||percentage of participants|||Number
1249319|NCT00517413|Secondary|Mean Ferritin Levels Over Time|Ferritin is a protein found inside cells that stores iron so that the body can use it later. A ferritin test indirectly measures the amount of iron in your blood. The Ferritin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for ferritin are as follows: Female: min-max for lower limit=6 - 50 mcg/L and min-max for upper limit=120 - 400 mcg/L; Male: min-max for lower limit=10 - 50 mcg/L and min-max for upper limit=200 - 400 mcg/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||mcg/L||Standard Deviation|Mean
1249320|NCT00517413|Secondary|Mean C-Reactive Protein Levels Over Time|C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The CRP test is a general test to check for inflammation in the body.The CRP levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for CRP are as follows: Female/Male: min-max for lower limit=0 - 10 mg/L and min-max for upper limit=0.5 - 30 mg/L.|Baseline (Week 0), 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||mg/L||Standard Deviation|Mean
1249321|NCT00517413|Secondary|Mean Albumin and Transferrin Levels Over Time|The albumin and transferrin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for albumin are as follows: Female/Male: min-max for lower limit=30 - 35 g/L and min-max for upper limit=48 – 55 g/L. The standard reference ranges for transferrin are as follows: Female/Male: min-max for lower limit=1.5 - 2.3 g/L and min-max for upper limit=2.87 - 4.3 g/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study.|||g/L||Standard Deviation|Mean
1249322|NCT00517413|Secondary|Mean Transferrin Saturation Levels Over Time|Transferrin saturation (TSAT) is the ratio of serum iron and total iron-binding capacity. Transferrin is a blood protein that picks up iron absorbed by the intestines and transports it from one location to another. When iron absorption is abnormally high, transferrin proteins become more saturated with iron. An elevated TS value therefore reflects an increase in iron absorption. The TSAT levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. TSAT was calculated automatically in the electronic case report form (eCRF) according to the following formulae: TSAT= (Serum Iron*100)/(Transferrin*1.41) or TSAT=(Serum Iron*100)/TIBC. Calculated data was not provided by laboratory; therefore no reference range is available.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||Percentage of Transferrin Saturation||Standard Deviation|Mean
1249323|NCT00517413|Secondary|Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time|The creatinine, iron, and total iron binding capacity (TIBC) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for creatinine are as follows: Female: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=79.56 - 123.76 mmol/L; Male: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=97.24 - 123.76 mmol/L. The standard reference ranges for iron are as follows: Female: min-max for lower limit=6.265 - 10.74 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L and Male: min-max for lower limit=6.265 - 11.635 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L. The standard reference ranges for TIBC are as follows: Female: min-max for lower limit=19.69 - 49.046 mmol/L and min-max for upper limit=62.65 - 88.963 mmol/L and Male: min-max for lower limit=19.69 - 52.089 mmol/L and min-max for upper limit=62.65 - 80.55 mmol/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||μmol/L||Standard Deviation|Mean
1249324|NCT00517413|Secondary|Mean Phosphate and Potassium Levels Over Time|The phosphate and potassium levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for phosphate are as follows: Female/Male: min-max for lower limit= 0.48435 - 0.9687 mmol/L and min-max for upper limit=1.45305 - 2.2603 mmol/L. The standard reference ranges for potassium are as follows: Female/Male: min-max for lower limit=3.1 - 3.7 mmol/L and min-max for upper limit=5 - 5.5 mmol/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||mmol/L||Standard Deviation|Mean
1249325|NCT00517413|Secondary|Mean White Blood Cells and Thrombocyte Levels Over Time|The white blood cells (WBC) and thrombocyte levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for WBC are as follows: Female/Male: min-max for lower limit= 3.5 - 5*10^9 cells/L and min-max of upper limit= 9 -13.5*10^9 cells/L. The standard reference ranges for thrombocyte are as follows: Female/Male: min-max for lower limit= 130 – 150*10^9 cells/L and min-max of upper limit= 300 - 450*10^9 cells/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||10^9 cells/L||Standard Deviation|Mean
1249326|NCT00517413|Secondary|Mean Hematocrit Levels Over Time|The haematocrit (HCT) levels in fraction were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for hematocrit are as follows: Female: min-max for lower limit=0.12 - 0.38 and min-max of upper limit=0.43 - 0.537; Male: min-max for lower limit=0.35 - 0.45 and min-max of upper limit=0.45 - 0.54.|Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1249327|NCT00517413|Secondary|Mean Haemoglobin Levels Over Time|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for Hb are as follows: Female: min-max for lower limit=11 to 13 g/dL and min-max for upper limit=14 to 18.1 g/dL; Male: min-max for lower limit=12 to 14.2 g/dL and min-max for upper limit=16 to 18.1 g/dL.|Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||g/dL||Standard Deviation|Mean
1249330|NCT00517413|Secondary|Mean Monthly Dose of C.E.R.A During the DTP and EEP|The initial dose of C.E.R.A. was 120, 200, or 360 mcg IV or SC every 4 weeks for 48 weeks, which was based on the last dose of the previous ESA. Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP and the EEP. The reference Hb value was taken as the mean of all Hb assessments during the stability verification period. The mean monthly doses of C.E.R.A during the DTP and EEP are presented.|Baseline (Week 0) to Week 24|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||mcg||Standard Deviation|Mean
1249331|NCT00517413|Secondary|Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP|Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant’s Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP (Week 0 to Week 16) and the EEP (Weeks 16 to 24). The reference Hb value was taken as the mean of all Hb assessments during the stability verification period (Weeks -4, -3, -2, -1). The percentage of participants requiring C.E.R.A dose adjustments during the DTP and EEP are presented.|Baseline (Week 0) to Week 24|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||Percentage of participants|||Number
1249332|NCT00517413|Secondary|Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean C.E.R.A dose required to maintain the Hb level within the range 10.5-12.5 g/dL throughout the EEP is presented.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||mcg||Standard Deviation|Mean
1249333|NCT00517413|Secondary|Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean time (days) spent by the participants in the Hb target range 10.5 to 12.5 is reported.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||days||Standard Deviation|Mean
1249334|NCT00517413|Secondary|Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The percentage of participants maintaining their mean Hb concentration within the target range 10.5 and 12.5 g/dL throughout the EEP are reported.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||Percentage of participants||95% Confidence Interval|Number
1249335|NCT00517413|Secondary|Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean change in the Hb concentration between the Stability Verification Period (SVP) and the EEP is reported.|SVP (Week -4 to -1), EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||g/dL||Standard Deviation|Mean
1249336|NCT00517413|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter|The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant’s all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP).|EEP (Week 16 to 24)|The Per-Protocol Population (PP) included all participants in the safety population except those who had <3 recorded Hb values; withdrawn; inadequate iron defined as mean serum ferritin =<100 nanogram/milliliter (ng/mL) or mean TSAT=<20% or mean hypochromic RBCs>=10%; or had missing administration of C.E.R.A. all during EEP (Week 16-24).|||Percentage of participants||95% Confidence Interval|Number
1249337|NCT00517361|Secondary|Correlation of Response to BRCA1 Methylation Status|The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.|Up to 5 years|This study has been terminated due to poor accrual.||||||
1249338|NCT00517361|Secondary|Duration of Response||Up to 5 years|This study has been terminated due to poor accrual.||||||
1249339|NCT00517361|Secondary|Response Rate|Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|Up to 5 years|This study has been terminated due to poor accrual.||||||
1249340|NCT00517361|Primary|Progression Free Survival|Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 5 years|This study has been terminated due to poor accrual.||||||
1249380|NCT00516893|Secondary|Annualized Relapse Rate|Annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of years the participant was followed in the study. The annualized relapse rate was based only on those relapses that were determined to meet the definition of relapse per the investigator’s clinical judgment. New or recurrent symptoms that occurred less than 30 days following the onset of a protocol-defined relapse were considered part of the same relapse.|Through Week 36|Participants who received at least 1 dose of study drug.|||relapses/participant-years|||Number
1249381|NCT00516893|Secondary|Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.|Baseline, Week 36|Participants with EDSS scores at Baseline and Week 36 (includes participants who withdrew from the study).|||scores on a scale||Standard Deviation|Mean
1249382|NCT00516893|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|AE: any sign, symptom, or diagnosis/disease that was unfavorable or unintended, new, or if pre-existing, worsened in a participant administered a study treatment and that did not necessarily have a causal relationship with this treatment. SAE: an event that resulted in death; an event that, in the view of the investigator, placed the participant at immediate risk of death (life-threatening event); an outcome that resulted in a congenital anomaly/birth defect diagnosed in a child of a participant in this study; an event that required or prolonged inpatient hospitalization; an event that resulted in persistent or significant disability/incapacity; any other medically important event that, in the opinion of the investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed above. Events were classified as ‘related’ or ‘not related’ to study drug, and categorized as ‘mild’ moderate’ or ‘severe’ per protocol.|AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.|Participants who received at least 1 dose of study drug.|||participants|||Number
1249383|NCT00516893|Primary|Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status|Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.|Assessed every 12 weeks from Week 0 (Baseline) to Week 36|Participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody assessment after the first dose.|||participants|||Number
1249384|NCT00516737|Secondary|Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose|"Level of functional disability was assessed on a paper diary by the participants.~Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose."|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
1249385|NCT00516737|Secondary|Number of Participants With Absence of Nausea at 2 Hours Post-dose|Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
1249386|NCT00516737|Secondary|Number of Participants With Absence of Phonophobia at 2 Hours Post-dose|Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
1249387|NCT00516737|Secondary|Number of Participants With Absence of Photophobia at 2 Hours Post-dose|Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
1249388|NCT00516737|Secondary|Number of Participants With no Rescue Use up to 24 Hours Post-Dose|Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.|24 hours post-dose|The FAS population included all randomized and treated participants.|||Participants|||Number
1249389|NCT00516737|Secondary|Number of Participants With 24-Hour Sustained Pain Freedom|24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.|24 hours post-dose|The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment.|||Participants|||Number
1249390|NCT00516737|Primary|Number of Participants Who Are Pain Free at 2 Hours Post-Dose|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.|2 hours post-dose|Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
1249391|NCT00516503|Secondary|Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 4 weeks|All patients that were assessed for adverse events are used in this analysis.|||Participants|||Count of Participants
1249392|NCT00516503|Secondary|Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks|The Peripheral Neuropathy Questionnaire was used to analyze this endpoint. Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic). The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.|Up to 4 weeks||||units on a scale * week||Standard Deviation|Mean
1249393|NCT00516503|Secondary|Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4|Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint. Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.|Up to 4 weeks||||units on a scale * week||Standard Deviation|Mean
1249394|NCT00516503|Secondary|Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)|Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score.|At 4 weeks||||units on a scale||Standard Deviation|Mean
1249395|NCT00516503|Secondary|Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the autonomic neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|Up to 4 weeks|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons.|||(units on a scale)*week||Standard Deviation|Mean
1249396|NCT00516503|Secondary|Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the motor neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|From Baseline to week 4|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse > event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an > adverse event, one patient died, and 18 refused for non-specified reasons.|||(units on a scale)* week||Standard Deviation|Mean
1249397|NCT00516503|Primary|Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20]|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0–100 scales so that a high score corresponds to better condition or less symptom. The primary analysis was the change in sensory neuropathy subscale of the CIPN-20 from baseline to week 4. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's sensory neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|From baseline to 4 weeks|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons.|||(units on a scale) * week||Standard Deviation|Mean
1249398|NCT00516386|Secondary|Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa||Baseline and 7-10 days||||ng/ml||Standard Error|Mean
1249399|NCT00516386|Primary|Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa||Baseline and 7-10 days|16 subjects were screened for the study, and 10 completed the study. 10 were analyzed.|||ng/ml||Standard Error|Mean
1249400|NCT00516321|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
1249401|NCT00516321|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Kilograms (kg)||Standard Deviation|Mean
1249474|NCT00515827|Secondary|Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From First Day of Treatment to Week 12|"Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are possibly, probably or definitely related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading."|From first day of treatment to week 12|All participants on study treatment|||Participant|||Number
1249402|NCT00516321|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase|Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||beats per minute||Standard Deviation|Mean
1249403|NCT00516321|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1249404|NCT00516321|Secondary|Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS."|End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1249405|NCT00516321|Secondary|Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of abnormal alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment."|DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. Worst ECG post-BL is the worst ECG assessment reported for a participant at a post-BL assessment and could be Normal, Abnormal - NCS, Abnormal - CS, or Abnormal (NCS or CS not given).|||participants|||Number
1249406|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase|Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population|||participants|||Number
1249407|NCT00516321|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population|||participants|||Number
1249408|NCT00516321|Secondary|Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase|Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population: all randomized participants who had received study drug in the DB Phase|||participants|||Number
1249419|NCT00516321|Secondary|Median Platelet Count at the Indicated Time Points During the OL Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Gi/L||Full Range|Median
1249537|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 12|Laboratory hematology lymphocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
1249409|NCT00516321|Secondary|Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase|There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study|||participants|||Number
1249410|NCT00516321|Secondary|Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase|The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1249411|NCT00516321|Secondary|Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase|The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. One participant could have had more than one dose reduction.|||participants|||Number
1249412|NCT00516321|Secondary|Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase|Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. Only those participants with dose reductions were analyzed.|||weeks||Standard Deviation|Mean
1249413|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase|Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1249414|NCT00516321|Secondary|Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase|ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.|From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1249415|NCT00516321|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Baseline up to Week 12|ITT Population|||participants|||Number
1249416|NCT00516321|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.|From Baseline up to Week 12|ITT Population|||participants|||Number
1249417|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase|The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
1249418|NCT00516321|Secondary|Median Platelet Count at the Indicated Time Points During the DB Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|ITT Population. Only those participants contributing data at the indicated time points were analyzed. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|||Gi/L||Full Range|Median
1249444|NCT00516139|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCH at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||picograms||Full Range|Median
1249420|NCT00516321|Secondary|Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase|In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.|From Baseline up to Week 9 in the OL Phase|Safety Population. Participants with a platelet count >=90 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.|||participants|||Number
1249421|NCT00516321|Secondary|Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase|Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in the OL Phase|Safety Population: all participants who had received study drug in the OL Phase|||participants|||Number
1249422|NCT00516321|Primary|Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase|Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase|||participants|||Number
1249423|NCT00516295|Primary|Time to Disease Progression in Patients Receiving VTC With or Without Bevacizumab|Time from enrollment to disease progression, death, second malignant neoplasm, or last patient follow-up whichever occurs first. Patients who experience disease progression, death or second malignant neoplasm will be considered to have experienced an event; otherwise the patient will be considered censored at last follow-up.|Maximum of 5 years after enrollment|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.|||days of event free survival||95% Confidence Interval|Median
1249424|NCT00516295|Primary|The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient.|Limiting toxicity defined as Any Grade IV hematological toxicities lasting longer than 7 days, myelosuppression causing delays > 14 days in delivery of therapy, > Grade 3 thromboembolic events, > Grade 3 bleeding events, > Grade 2 hypertension, > Grade 2 proteinuria.|First 2 courses (42 days) of therapy|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.|||number of toxicities|||Number
1249425|NCT00516269|Primary|Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement|"The primary endpoint is the “fatigue worst” score (range: 0 – 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). Worst fatigue is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in “fatigue worst” score between post-Methylphenidate measurement and post-Placebo measurement."|At end of two 2-week treatment cycles (4 weeks total)|It is a crossover design and only the 33 patients who completed the study were included in the final data analysis.|||units on a scale||Standard Deviation|Mean
1249426|NCT00516217|Secondary|6 Month Progression Free Survival Rate|"Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.~Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node."|6 months||||percentage of participants||95% Confidence Interval|Number
1249427|NCT00516217|Secondary|12 Month Overall Survival Rate|Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.|12 months||||percentage of participants||95% Confidence Interval|Number
1249428|NCT00516217|Primary|Overall Response|"Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.~CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions."|Duration of treatment (up to 10 years)||||participants|||Number
1249429|NCT00516165|Secondary|Overall Survival|The median overall survival was 8.4 months (95% CI, 3.9-21.1 months). Only 2 ((8 %) patients were progression-free at 24 weeks. The study did not proceed to the second stage of the phase 2 portion of the study.|2 years||||months||95% Confidence Interval|Median
1249430|NCT00516165|Secondary|Time to Progression|3.9 months with a CI of 21-|2 years||||month||95% Confidence Interval|Median
1249431|NCT00516165|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||percentage of patient response||95% Confidence Interval|Number
1249432|NCT00516165|Secondary|Number of Patients With Adverse Events Who Were Treated With RAD001 for Advanced HCC|Everolimus given at 10 mg/day as a single agent was well tolerated in patients with advanced HCC.|2 years|Patients with histologically confirmed measurable advanced HCC. The primary end points were determination of a safe dosage of everolimus and progression-free survival at 24 weeks.|||Participants|||Count of Participants
1249433|NCT00516165|Primary|Progression-free Survival Rate at 24 Weeks|"Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~This information will be collected during two years of patient participation."|2 years||||months||95% Confidence Interval|Median
1249434|NCT00516165|Primary|Maximum Tolerated Dose of RAD001 in Patients With Advanced Hepatocellular Carcinoma (HCC).||2 years|Patients with histologically confirmed measurable advanced Hepatocellular Carcinoma.|||mg|||Number
1249435|NCT00516139|Secondary|Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. KA is defined as the rate at which a drug enters the body after administration. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.|||1/h||95% Confidence Interval|Mean
1249436|NCT00516139|Secondary|Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. V/F is defined as the apparent volume in which a drug is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.|||liters||95% Confidence Interval|Mean
1249437|NCT00516139|Secondary|Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. Clearance is defined as the volume of LTG per unit time eliminated from serum. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to Clinical Pharmacokinetics Modelling and Simulation, Clinical Pharmacology, and Discovery Medicine (CPDM) by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.|||Liters per hour||95% Confidence Interval|Mean
1249438|NCT00516139|Secondary|Serum LTG Concentrations at Different LTG Doses Based on the Concomitant AED Groups: Neutral (Without Known Enzyme-inducing AED [EIAED], Valproate [VPA]) With EIAED, and With VPA|The blood samples were collected at the specified study visits; however, serum LTG concentrations were summarized by dose regimen, not by study week. The serum was assayed for LTG using an approved method under the management of Worldwide Bioanalysis, GlaxoSmithKline.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.|||Micrograms per milliliter|serum concentrations|Full Range|Median
1249439|NCT00516139|Secondary|Change From Baseline in Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Glucose, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of cholesterol, HDL cholesterol, LDL cholesterol, glucose, potassium, sodium, triglycerides, and urea/BUN at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||millimoles (mmol) per liter||Full Range|Median
1249440|NCT00516139|Secondary|Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of DB, TB, and creatinine at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||micromoles (µmol) per liter||Full Range|Median
1249441|NCT00516139|Secondary|Change From Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of Alk P, Ala AT, and Asp AT at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||International units per liter||Full Range|Median
1249442|NCT00516139|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of RBC count at the indicated time points in the study from the Baseline value. Change from baseline is measured as the number of red blood cells x 10^12 per liter.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Tera (10^12) cells per liter||Full Range|Median
1249443|NCT00516139|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCV at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Femtoliters||Full Range|Median
1249445|NCT00516139|Secondary|Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the values of MCHC, albumin, and total protein at the indicated time points in the study from the respective Baseline values.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||grams per liter||Full Range|Median
1249446|NCT00516139|Secondary|Percent Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count, Platelet Count, and White Blood Cell Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Percent change from Baseline = (value at each indicated time point in the study minus respective Baseline value divided by Baseline value) x 100.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Percent change in counts||Full Range|Median
1249447|NCT00516139|Secondary|Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of basophil, eosinophil, hemoglobin, lymphocyte, monocyte, ANC, platelet count, and WBC count at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Giga (10^9) cells per liter||Full Range|Median
1249448|NCT00516139|Secondary|Change From Baseline in the Weight at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the value of weight measured by the investigator at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||kilograms||Standard Deviation|Mean
1249449|NCT00516139|Secondary|Change From Baseline in the Height at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the value of height measured by the investigator at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||centimeters||Standard Deviation|Mean
1249450|NCT00516139|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the values of systolic and diastolic blood pressures recorded by the investigator at the indicated time points in the study from the respective Baseline values.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1249451|NCT00516139|Secondary|Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale|Investigators rated the participants' overall clinical status at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants’ condition had not changed compared to their Baseline condition.|Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])|Safety Population. Participants with missing data were not analyzed.|||participants|||Number
1249452|NCT00516139|Secondary|Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale|Investigators rated the participants' seizure severity at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants’ condition had not changed compared to their Baseline condition.|Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])|Safety Population. Only those participants who had seizures at baseline were analyzed.|||participants|||Number
1249453|NCT00516139|Secondary|Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period|Participants were considered to be seizure-free if they did not report any seizures at Baseline.|Week 30 or 33|Safety Population. Participants who were seizure-free at Baseline were analyzed.|||participants|||Number
1249454|NCT00516139|Secondary|Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study|Participants recorded the number of seizures, by seizure type, as well as the duration of episodes of innumerable seizure activity in their daily diaries during all phases of the study. For participants who withdrew from the study, seizure data were averaged for the portion of the study the participant completed up to the time of study drug discontinuation. Participants who experienced a change from Baseline in the weekly seizure frequency were categorized as having a >=25%, >=50%, >=75%, or 100% reduction or a >=50% increase in percent change from Baseline in weekly seizure frequency.|Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33)|Safety Population. Only those participants who had seizures at baseline were analyzed.|||participants|||Number
1249455|NCT00516139|Secondary|Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study|Partial-onset sz. have a focal site of onset; sz. activity is initially limited to 1 brain hemisphere. Partial sz. can remain simple or complex, or evolve to generalized tonic-clonic sz. Participants (par.) recorded the number of sz., by type as well as the episode duration of innumerable sz. activity), in daily diaries. If par. withdrew from study, data were averaged for the study portion the par. completed up to the time of drug discontinuation. Percent change from BL = (BL value minus study phase value divided by BL value) x 100; positive values indicate reduction from BL in sz. frequency.|Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33)|Safety Population. Only those participants who had seizures at baseline were analyzed.|||Percent change in seizure frequency||Full Range|Median
1249456|NCT00516139|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.|From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33)|Safety Population: all participants who were enrolled and took at least one dose of study drug|||participants|||Number
1249457|NCT00516074|Secondary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint|Change from baseline to endpoint in HbA1c|12 weeks|Intent to treat; Last observation carried forward|||percent||Standard Error|Least Squares Mean
1249458|NCT00516074|Secondary|Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint|Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1249459|NCT00516074|Secondary|Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint|Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1249460|NCT00516074|Secondary|Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward|||beats per minute||Standard Error|Least Squares Mean
1249461|NCT00516074|Secondary|Change in Daytime Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward|||beats per minute||Standard Error|Least Squares Mean
1249462|NCT00516074|Primary|Change in Mean 24-hour Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.|12 weeks|Intent to treat; Last observation carried forward|||beats per minute||Standard Error|Least Squares Mean
1249463|NCT00516048|Primary|Incidence of Potentially Immune-related Treatment-emergent Adverse Events|Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study|24 weeks|Intent to Treat|||participants|||Number
1249464|NCT00516048|Secondary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint|Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status|24 weeks|Intent to Treat; Last Observation Carried Forward|||percent||Standard Deviation|Mean
1249465|NCT00516048|Primary|Treatment-emergent Antibody Status (Maximum Titer Level Experienced)|Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)|24 weeks|Intent to Treat|||Participants|||Number
1249466|NCT00515879|Secondary|Range of Impaired Functioning Tool||Measured at Months 3, 6, and 9 post-treatment|||||||
1249467|NCT00515879|Secondary|Liebowitz Self-Rated Disability Scale||Measured at Months 3, 6, and 9 post-treatment|||||||
1249468|NCT00515879|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire||Measured at Months 3, 6, and 9 post-treatment|||||||
1249469|NCT00515879|Secondary|Social Phobia and Anxiety Inventory||Measured at Months 3, 6, and 9 post-treatment|||||||
1249470|NCT00515879|Primary|Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).|Measured at Months 3||||LSAS scores||95% Confidence Interval|Mean
1249471|NCT00515879|Primary|Social Phobic Disorders Severity and Change Form|Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).|Measured at Months 3 (immediately after treatment)||||Units on a scale||95% Confidence Interval|Mean
1249472|NCT00515827|Secondary|Number of Participants Who Discontinued Study Drug|Participants who discontinued randomized study treatment for any reason|From first day of treatment to week 12|All 53 participants|||Participant|||Number
1249473|NCT00515827|Secondary|Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From Week 12 to Week 24|Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are 'possibly', probably', or definitely' related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading.|From week 12 to week 24||||participants|||Number
1249475|NCT00515827|Secondary|Change in CD8+/CD38+/HLA-DR+ Percent|Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD8+/CD38+/HLA-DR+% at week 12 minus CD8+/CD38+/HLA-DR+% at baseline.|At pre-entry, entry, and week 12|All participants who stayed on study treatment and had not experienced virologic failures.|||% CD8 cells co-express CD38+ and HLA-DR+||Inter-Quartile Range|Median
1249476|NCT00515827|Secondary|Change in CD4+/CD38+/HLA-DR+ Percent|Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD4+/CD38+/HLA-DR+% at week 12 minus CD4+/CD38+/HLA-DR+% at baseline.|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure|||% CD4 cells co-express CD38+ and HLA-DR+||Inter-Quartile Range|Median
1249477|NCT00515827|Secondary|Change in Total CD8 Cell Count|CD8 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure|||cells/mm^3||Inter-Quartile Range|Median
1249478|NCT00515827|Secondary|Change in Total CD4 Cell Count|CD4 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure|||cells/mm^3||Inter-Quartile Range|Median
1249479|NCT00515827|Secondary|Change in HIV-1 RNA Level|Change in HIV-1 RNA level, as measured by single copy assay, from baseline to weeks 10/12 . When averaging the measurements at pre-entry and entry, and at weeks 10 and 12, measurements below the lower limit of quantification (LLQ) were imputed a value of the LLQ divided by 2.|At pre-entry, entry, weeks 10 and 12|All participants who were on study treatment and had not experienced virologic failure|||copies/mL||Inter-Quartile Range|Median
1249480|NCT00515827|Primary|HIV-1 RNA Level|HIV-1 RNA level, as measured by single copy assay, averaged at weeks 10 and 12. The quantification limit of single copy assay was determined by the volume of plasma tested. When averaging the week 10 and 12 measurements, if one of both measurements were below the single copy assay lower limits, the lower limit of quantification was used to compute the average and the result was treated as below the averaged value.|At Weeks 10 and 12|49 subjects who were on study treatment before week 10 and did not experience virologic failure by week 12|||copies/mL||Inter-Quartile Range|Median
1249481|NCT00515697|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to study completion (up to 34 months) plus 30-day safety follow-up|Intent-to-treat population: participants who received any quantity of ramucirumab.|||participants|||Number
1249482|NCT00515697|Secondary|Maximum Concentration (Cmax) of Ramucirumab||1 hour after the end of the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]|Participants who received any quantity of ramucirumab and had evaluable pharmacokinetic data at the specified time point.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1249483|NCT00515697|Secondary|Minimum Concentration (Cmin) of Ramucirumab||Immediately prior to the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]|Participants who received any quantity of ramucirumab and had evaluable pharmacokinetic data at the specified time point.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1249484|NCT00515697|Secondary|Median Duration of Overall Response|Duration of response is the interval from the date of initial documented response [confirmed complete response (CR) or partial response (PR)] to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data from participants who did not relapse were censored on the day of their last tumor assessment.|Time of first response (CR or PR) to disease progression, initiation of other (or additional) antitumor therapy, or death due to any cause (up to 34 months)|Participants who received any quantity of ramucirumab and had confirmed complete response or partial response. The number of participants censored was 1.|||months||95% Confidence Interval|Median
1249485|NCT00515697|Secondary|Percentage of Participants With Objective Response (Objective Response Rate) at 12 Weeks|The percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at Week 12, as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved at 12 weeks was CR or PR/number of participants treated)*100.|Week 12 [Cycle 6 (1 cycle=14 days)]|Intent-to-treat population: participants who received any quantity of ramucirumab.|||percentage of participants||95% Confidence Interval|Number
1249518|NCT00515502|Primary|Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hemoglobin, MCHC, albumin and total protein at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Grams per liter (G/L)||Standard Deviation|Mean
1249538|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 6|Laboratory hematology lymphocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
1249486|NCT00515697|Secondary|Percentage of Participants Showing Disease Control at Week 12|Participants who were alive and did not experience disease progression were considered to have disease control at 12 weeks. Disease control was based on lack of disease progression using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. According to RECIST criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or detection of new lesion. Participants whose disease progression was symptomatic were not considered to have disease control. The percentage of participants showing disease control=(number of participants who did not have disease or symptomatic progression at Week 12/number of participants treated)*100.|Week 12 [Cycle 6 (1 cycle=14 days)]|Intent-to-treat population: participants who received any quantity of ramucirumab.|||percentage of participants||95% Confidence Interval|Number
1249487|NCT00515697|Secondary|Progression-Free Survival|Progression-free survival (PFS) is measured from the date of the first dose to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria or death from any cause. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data for participants whose disease does not progress or for whom no post-baseline assessment is made are censored at the day of their last tumor assessment. Data for participants whose disease does not progress who are subsequently lost to follow-up are also censored at the day of their last tumor assessment.|First dose to measured progressive disease or death due to any cause (up to 34 months)|Intent-to-treat population: participants who received any quantity of ramucirumab. The number of participants censored was 4.|||months||95% Confidence Interval|Median
1249488|NCT00515697|Primary|Percentage of Participants With Objective Response (Objective Response Rate)|The percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response during therapy is CR or PR/number of participants treated)*100.|First dose to date of objective progressive disease or death due to any cause (up to 34 months)|Intent-to-treat population: participants who received any quantity of ramucirumab.|||percentage of participants||95% Confidence Interval|Number
1249489|NCT00515671|Secondary|Psychiatric Symptoms (PANSS Total)|Psychiatric symptomatology was assessed by the Positive and Negative Syndrome Scale (PANSS), a widely-used, 30-item rating scale. The PANSS has previously demonstrated satisfactory internal consistency, test-retest reliability, and validity. Raters were trained to reach inter-rater agreement of .80 prior to interviewing participants. This is the total score, which ranges from 30 to 210, with higher scores indicating more severe symptoms.|Baseline, 9 months, 18 months||||units on a scale||Standard Deviation|Mean
1249490|NCT00515671|Primary|Illness Management Ratings|Illness self-management was assessed with the consumer-rated Illness Management and Recovery Scale. Items are rated on a 5-point behaviorally anchored scale; the mean across all 15 items forms an overall score of illness management (ranging from 1 to 5), with higher scores indicating better self-management.|Baseline, 9 months, 18 months||||units on a scale||Standard Deviation|Mean
1249491|NCT00515619|Secondary|Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency|Treatment Period (up to 5.5 years)|Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.|||Percentage of subjects|||Number
1249492|NCT00515619|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)|"Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.~Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency."|Baseline, Treatment Period (up to 5.5 years)|Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.|||Percentage change||Full Range|Median
1249493|NCT00515619|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||Subjects|||Number
1249494|NCT00515619|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||Subjects|||Number
1249495|NCT00515619|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||Subjects|||Number
1249496|NCT00515541|Primary|EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid|Measurements were made using a modified device (EQELS) to specifications of constant current, high electric field and a scattering angle of 30 degrees. EQELS provides a sensitive assessment of subtle changes in the cell surface that occurs with activation, ligand binding or apoptosis. These changes are the result of different distributions of charged groups that define a surface charge finger print for the current state of activation of the cell. Resting state platelets have a negative surface charge, whereas fully activated platelets have a positive surface charge.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks. Change in EQELS value after the addition of Arachidonic Acid.|||mobility units||Inter-Quartile Range|Median
1249497|NCT00515541|Primary|Bleeding Time|Bleeding time is a measure of how well platelets interact with blood vessel walls to form a clot. A manual blood pressure cuff is placed 2 inches above the antecubital fossa and inflated to 40mmHg. Using a standard Surgicutt device, a small incision is made and a stopwatch is started. The incision edge is blotted at 30 second intervals with standard filter paper until the bleeding has stopped. The time to hemostasis is noted.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks|||seconds||Inter-Quartile Range|Median
1249498|NCT00515541|Secondary|The Occurence of Any Type of Bleeding|was there any bleeding occurance during the accessed interval|up to and including closeout at 24 weeks|Subjects would indicate if they had any bleeding episode during the trial at each of their testing intervals|||Number of occurance|||Number
1249499|NCT00515541|Primary|Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)|The PAP-8E measures platelet aggregation in platelet rich plasma (PRP). Platelet responses to a series of common agonists cause changes in optical density that are measured. The instrument is blanked (100% baseline (optimal transmission)) by inserting a platelet poor plasma (PPP) specimen into the appropriate channel. The PRP is then inserted into the same well. The difference in optical density between the PPP and the PRP 0% baseline (optical transmission) is recorded for several minutes when the agonist reagent is added to the PRP.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks|||percent||Inter-Quartile Range|Median
1249500|NCT00515502|Secondary|Mean Serial Specific Airway Resistance (sGaw) Over 24 Hours After Dosing on Day 1 of Each Treatment Period|sGaw is the specific airways resistance (mid) which was assessed by whole body plethysmography. Values used were the mean of the 3 readings recorded at each timepoint. sGaw measurements were taken at 2 hour (h), 6 h, 12 h and 24 h post-dose of each treatment period. 1/kPa.s=1(the inverses)/kPa (kilopascal).s (second)|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||1/kPa*s||Standard Error|Geometric Mean
1249501|NCT00515502|Secondary|Mean Serial FEV1over 24 Hours After Dosing on Day 1 of Each Treatment Period|Serial spirometry assessments were conducted on Day 1 of each treatment period over the course of 24 hours and were taken at 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose. The maximum of the 3 FEV1 measurements for each participant, treatment period and timepoint were used in the calculation of the mean for each treatment group at each timepoint.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Error|Least Squares Mean
1249502|NCT00515502|Secondary|Fraction of Dose Excreted Unchanged in Urine From Time Zero to: 24 Hours [Fe(0-24)] and 48 Hours [Fe(0-48)] for UMEC|Urine samples were collected to determine the urine concentrations of UMEC from 0 min up to 48 hours post-dose of each treatment period to derive Fe(0-24) and Fe(0-48). Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||Percentage of total dose administered||Full Range|Median
1249503|NCT00515502|Secondary|Half-life for Renal Excretion of UMEC on Day 1|The terminal half-life (t1/2) of UMEC is defined as the time required for the urine concentration of UMEC to reach half of its original concentration. Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
1249504|NCT00515502|Secondary|Renal Clearance (CLr) of UMEC Following Dose Administration on Day 1|The CLr is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1249505|NCT00515502|Secondary|Amount of Drug Excreted Unchanged in Urine From Time Zero to: 2h [Ae(0-2)] , 8h [Ae(0-8)], 12h [Ae(0-12)], 24h [Ae(0-24)], and 48h [Ae(0-48)]; and Area Under the Excretion Rate Curve From Time Zero to: 18h [AUER(0-18)] and 36h [AUER(0-36)] for UMEC|Urine samples were collected to determine the urine concentrations of UMEC from 0 min up to 48 hours post-dose of each treatment period to derive Ae(0-2), Ae(0-8), Ae(0-12), Ae(0-24), Ae(0-48), AUER(0-18) and AUER(0-36). Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||ng||Geometric Coefficient of Variation|Geometric Mean
1249519|NCT00515502|Primary|Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Percentage||Standard Deviation|Mean
1249506|NCT00515502|Secondary|Time of Maximum Observed Plasma Concentration (Tmax), Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast), and Plasma Half-life (t1/2) of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive tmax, tlast and t1/2. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population. Only those participants with non-missing observations (including non-calculable values) were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the PK Population|||Hours||Full Range|Median
1249507|NCT00515502|Secondary|Maximum Observed Plasma Concentration (Cmax) of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive the Cmax. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1249508|NCT00515502|Secondary|Area Under Concentration-time Curve From Time 0 to 2 Hours [AUC(0-2)] and Area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-t)] of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive the AUC(0-2) and AUC(0-t). Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|Pharmacokinetic (PK) Population:all participants in the All Subjects Population for whom a PK sample was obtained and analyzed.|||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1249509|NCT00515502|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points on Day 1 of Each Treatment Period|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC measurements were taken at pre-dose and 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
1249510|NCT00515502|Primary|Calcium, Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the calcium, bicarbonate, chloride, glucose, IP, potassium, sodium, and urea at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1249511|NCT00515502|Primary|Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1249512|NCT00515502|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of ALP, ALT, AST, CPK, and GGT at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1249513|NCT00515502|Primary|Platelets Count and White Blood Cells (WBC) Count Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of platelets count and WBC count at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1249514|NCT00515502|Primary|Red Blood Cells Count Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the red blood cells count at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1249515|NCT00515502|Primary|Mean Corpuscle Volume Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the mean corpuscle volume at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Femtoliters (FL)||Standard Deviation|Mean
1249516|NCT00515502|Primary|Mean Corpuscle Hemoglobin Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the mean corpuscle hemoglobin at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||picograms/cell (pg)||Standard Deviation|Mean
1249517|NCT00515502|Primary|Hematocrit Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
1249520|NCT00515502|Primary|Mean (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period|Twenty-four-hour Holter monitoring was conducted to measure heart rate for the 24-h period following dosing of each treatment period and the mean value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
1249521|NCT00515502|Primary|Maximum (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period|Twenty-four hour Holter monitoring was conducted to measure heart rate for the 24-hour period following dosing at each treatment period and the maximum value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
1249522|NCT00515502|Primary|Weighted Mean (0-4 Hours) QTcF at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QTcF at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Milliseconds (msec)||Standard Error|Least Squares Mean
1249523|NCT00515502|Primary|Maximum (0-4 Hours) QTcF at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QT interval corrected according to Fredericia’s formula (QTcF) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Milliseconds (msec)||Standard Error|Least Squares Mean
1249524|NCT00515502|Primary|Weighted Mean (0-4 Hours) QTcB at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QTcB at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Milliseconds (msec)||Standard Error|Least Squares Mean
1249525|NCT00515502|Primary|Maximum (0-4 Hours) QTcB at Day 1 of Each Treatment Period|Twelve-lead ECGs (electrocardiograms) were performed to measure QT interval corrected according to Bazzet's formula (QTcB) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Milliseconds (msec)||Standard Error|Least Squares Mean
1249526|NCT00515502|Primary|Weighted Mean (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period|Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1249535|NCT00515463|Secondary|Monocytes Change From Baseline at Month 6|Laboratory hematology monocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
1249527|NCT00515502|Primary|Maximum (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period|Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1249528|NCT00515502|Primary|Weighted Mean (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period|Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1249529|NCT00515502|Primary|Maximum (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period|Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1249530|NCT00515502|Primary|Weighted Mean (0-4 Hours) Heart Rate at Day 1 of Each Treatment Period|Resting heart rate was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for heart rate (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
1249531|NCT00515502|Primary|Maximum (0-4 Hours) Heart Rate on Day 1 of Each Treatment Period|Resting heart rate was measured at pre-dose and 15 minutes (min), 45min, 1.5 hour (h) 4 h, 8 h, and 24 h post-dose of each treatment period and the maximum value for heart rate (0-4hours) was derived at rest. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
1249532|NCT00515502|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day 1 of Treatment Period 1until Follow-up (up to 10 weeks)|All Subjects Population: all participants who received at least one dose of study medication.|||Participants|||Number
1249533|NCT00515463|Secondary|Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3|Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Day 1 to Month 12|Patients who received ≥ 1 dose of investigational product.|||Participants|||Number
1249534|NCT00515463|Secondary|Monocytes Change From Baseline at Month 12|Laboratory hematology monocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
1249539|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 1|Laboratory hematology lymphocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
1249540|NCT00515463|Secondary|Basophils Change From Baseline at Month 12|Laboratory hematology basophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
1249541|NCT00515463|Secondary|Basophils Change From Baseline at Month 6|Laboratory hematology basophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
1249542|NCT00515463|Secondary|Basophils Change From Baseline at Month 1|Laboratory hematology basophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
1249543|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 12|Laboratory hematology eosinophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
1249544|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 6|Laboratory hematology eosinophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
1249545|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 1|Laboratory hematology eosinophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
1249546|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 12|Laboratory hematology total neutrophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
1249547|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 6|Laboratory hematology total neutrophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
1249548|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 1|Laboratory hematology total neutrophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
1249549|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 12|Laboratory hematology white blood cells|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
1249550|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 6|Laboratory hematology white blood cells|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
1249551|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 1|Laboratory hematology white blood cells|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
1249552|NCT00515463|Secondary|Platelets Change From Baseline at Month 12|Laboratory hematology platelets|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
1249553|NCT00515463|Secondary|Platelets Change From Baseline at Month 6|Laboratory hematology platelets|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
1249554|NCT00515463|Secondary|Platelets Change From Baseline at Month 1|Laboratory hematology platelets|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
1249555|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 12|Laboratory hematology reticulocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
1249556|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 6|Laboratory hematology reticulocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
1249557|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 1|Laboratory hematology reticulocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
1249558|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 12|Laboratory hematology hemoglobin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||g/L||Standard Deviation|Mean
1249559|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 6|Laboratory hematology hemoglobin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||g/L||Standard Deviation|Mean
1249560|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 1|Laboratory hematology hemoglobin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||g/L||Standard Deviation|Mean
1249561|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 12|Laboratory hematology red blood cells|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^12/L||Standard Deviation|Mean
1249562|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 6|Laboratory hematology red blood cells|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^12/L||Standard Deviation|Mean
1249563|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 1|Laboratory hematology red blood cells|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^12/L||Standard Deviation|Mean
1249564|NCT00515463|Secondary|Glucose Change From Baseline at Month 12|Laboratory chemistry glucose|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
1249565|NCT00515463|Secondary|Glucose Change From Baseline at Month 6|Laboratory chemistry glucose|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
1249566|NCT00515463|Secondary|Glucose Change From Baseline at Month 1|Laboratory chemistry glucose|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
1249567|NCT00515463|Secondary|Total Protein Change From Baseline at Month 12|Laboratory chemistry total protein|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||g/L||Standard Deviation|Mean
1249568|NCT00515463|Secondary|Total Protein Change From Baseline at Month 6|Laboratory chemistry total protein|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||g/L||Standard Deviation|Mean
1249569|NCT00515463|Secondary|Total Protein Change From Baseline at Month 1|Laboratory chemistry total protein|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||g/L||Standard Deviation|Mean
1249570|NCT00515463|Secondary|Albumin Change From Baseline at Month 12|Laboratory chemistry albumin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||g/L||Standard Deviation|Mean
1249571|NCT00515463|Secondary|Albumin Change From Baseline at Month 6|Laboratory chemistry albumin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||g/L||Standard Deviation|Mean
1249572|NCT00515463|Secondary|Albumin Change From Baseline at Month 1|Laboratory chemistry albumin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||g/L||Standard Deviation|Mean
1249573|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 12|Laboratory chemistry total bilirubin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||umol/L||Standard Deviation|Mean
1249574|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 6|Laboratory chemistry total bilirubin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||umol/L||Standard Deviation|Mean
1249575|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 1|Laboratory chemistry total bilirubin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||umol/L||Standard Deviation|Mean
1249576|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 12|Laboratory chemistry alanine amino transferase|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||U/L||Standard Deviation|Mean
1249577|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 6|Laboratory chemistry alanine amino transferase|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||U/L||Standard Deviation|Mean
1249578|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 1|Laboratory chemistry alanine amino transferase|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||U/L||Standard Deviation|Mean
1249579|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 12|Laboratory chemistry aspartate amino transferase|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||U/L||Standard Deviation|Mean
1249580|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 6|Laboratory chemistry aspartate amino transferase|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||U/L||Standard Deviation|Mean
1249581|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 1|Laboratory chemistry aspartate amino transferase|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||U/L||Standard Deviation|Mean
1249582|NCT00515463|Secondary|Creatinine Change From Baseline at Month 12|Laboratory chemistry creatinine|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||umol/L||Standard Deviation|Mean
1249583|NCT00515463|Secondary|Creatinine Change From Baseline at Month 6|Laboratory chemistry creatinine|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||umol/L||Standard Deviation|Mean
1249584|NCT00515463|Secondary|Creatinine Change From Baseline at Month 1|Laboratory chemistry creatinine|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||umol/L||Standard Deviation|Mean
1249585|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 12|Laboratory chemistry blood urea nitrogen|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
1249586|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 6|Laboratory chemistry blood urea nitrogen|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
1249587|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 1|Laboratory chemistry blood urea nitrogen|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
1249588|NCT00515463|Secondary|Magnesium Change From Baseline at Month 12|Laboratory chemistry magnesium|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
1249589|NCT00515463|Secondary|Magnesium Change From Baseline at Month 6|Laboratory chemistry magnesium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
1249590|NCT00515463|Secondary|Magnesium Change From Baseline at Month 1|Laboratory chemistry magnesium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
1249591|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 12|Laboratory chemistry bicarbonate|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
1249592|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 6|Laboratory chemistry bicarbonate|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
1249593|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 1|Laboratory chemistry bicarbonate|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
1249594|NCT00515463|Secondary|Chloride Change From Baseline at Month 12|Laboratory chemistry chloride|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
1249595|NCT00515463|Secondary|Chloride Change From Baseline at Month 6|Laboratory chemistry chloride|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
1249596|NCT00515463|Secondary|Chloride Change From Baseline at Month 1|Laboratory chemistry chloride|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
1249597|NCT00515463|Secondary|Potassium Change From Baseline at Month 12|Laboratory chemistry potassium|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
1249598|NCT00515463|Secondary|Potassium Change From Baseline at Month 6|Laboratory chemistry potassium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
1249599|NCT00515463|Secondary|Potassium Change From Baseline at Month 1|Laboratory chemistry potassium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
1249600|NCT00515463|Secondary|Sodium Change From Baseline at Month 12|Sodium Change From Baseline at Month 12|Baseline, Month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
1249601|NCT00515463|Secondary|Sodium Change From Baseline at Month 6|Laboratory chemistry sodium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
1249602|NCT00515463|Secondary|Sodium Change From Baseline at Month 1|Laboratory chemistry sodium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
1249603|NCT00515463|Secondary|Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12|Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.|Month 12|Patients testing positive for binding antibodies to denosumab.||||||
1249604|NCT00515463|Secondary|Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12|An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.|12 months|Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 12 months.|||Participants|||Number
1249605|NCT00515463|Primary|Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6|An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.|6 months|Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 6 months.|||Participants|||Number
1249606|NCT00515437|Secondary|Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection|"saliva collected over 5 minutes and weighed to produce a grams/minute rate"|baseline vs 12 weeks post-injection||||grams/minute||Standard Deviation|Mean
1249607|NCT00515437|Secondary|Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection|"saliva is collected over 5 minutes and weighed to produce a grams/minute rate"|baseline vs 4 weeks post-injection||||grams/minute||Standard Deviation|Mean
1249608|NCT00515437|Secondary|Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection|9 point scale (0=no drooling, 9=severe drooling)|baseline vs 12 weeks post injection||||points on a scale||Standard Deviation|Mean
1249609|NCT00515437|Primary|Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection|9 point scale, 0 = no drooling, 9 = severe drooling|baseline versus 4 weeks post-injection|Intent to Treat (ITT)|||points on a scale||Standard Deviation|Mean
1249610|NCT00515294|Secondary|Psycho-motor Vigilance Test (PVT)|Participants completed 10 test trials to assess their psycho-motor response using a hand held box that randomly starts a scroll of numbers in milliseconds and as soon as it starts to scroll the participant needs to press a button to stop the scrolling. The mean and standard deviations for the 10 tests were calculated as a single outcome score for each study arm. Response times were measured in milliseconds. The lower the number of milliseconds the faster the response to the random stimuli.|30 minutes post dosing||||milliseconds||Standard Deviation|Mean
1249611|NCT00515294|Primary|Lane Position Deviation|The reported lane position deviation indicates the position of the car relative to the center line in feet in the driver simulator. A deviation of 0 indicates no deviation from the center line (the car is positioned farthest from the road edge). Negative numbers indicate deviations to the right of the center line with the car positioned within the lane closer to the road edge. Positive numbers indicate deviations to the left of the center line with the car positioned in the lane of oncoming traffic closer to the road edge|30 minutes post dosing|Driver simulator did not work properly for 6 participants. Their data are not included.|||feet||Standard Deviation|Mean
1249612|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the MDR1 c.3435C>T (rs1045642) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
1249613|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the XRCC1 c.1196G>A (rs25487) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
1249614|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the GSTP1 c.313A>G (rs1695) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
1249615|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the ERCC2 c.2251A>C (rs13181) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
1249616|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the ERCC1 c.354C>T (rs11615) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
1249617|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
1249618|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G>C (rs34743033) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
1249619|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the MDR1 c.3435C>T (rs1045642) gene had a partial response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
1249620|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the XRCC1 c.1196G>A (rs25487) gene had a partial response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
1249621|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the GSTP1 c.313A>G (rs1695) gene had a partial response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
1249622|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the ERCC2 c.2251A>C (rs13181) gene had a partial response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
1249623|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the ERCC1 c.354C>T (rs11615) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
1249624|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
1249625|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G>C (rs34743033) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
1249626|NCT00515216|Secondary|Tumor Specific Changes That May Alter Treatment Outcomes||4 years|This was not completed as the archived tumor samples were not of sufficient quality for DNA extraction or analysis.||||||
1249627|NCT00515216|Secondary|Disease Control Rate (DCR)|"DCR - complete response, partial response, and stable disease~Complete response - disappearance of all target and non-target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Stable disease - neither sufficient shrinkage to qualify for partial response not sufficient increase to qualify for progressive disease"|2 years||||percentage of participants||95% Confidence Interval|Number
1249628|NCT00515216|Secondary|Progression-free Survival (PFS)|Progressive disease - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|4 years||||months||95% Confidence Interval|Median
1249629|NCT00515216|Secondary|Overall Survival||4 years||||months||95% Confidence Interval|Median
1249630|NCT00515216|Primary|Overall Response Rate (ORR)|"ORR = complete response + partial response~Complete response - disappearance of all target and non-target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter"|2 years||||percentage of participants||95% Confidence Interval|Number
1249631|NCT00515203|Primary|Adverse Events|Occurrence of one or more adverse events in the participant during the 12-week treatment period|12 weeks|Safety Analysis Set, composed of all participants who received at least one dose of study medication|||Participants|||Number
1249632|NCT00515203|Secondary|Requirement for Rescue Therapy (as Defined Per Protocol)|Participant required rescue therapy (as defined per protocol) during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants|||Participants|||Number
1249633|NCT00515203|Secondary|Increase in Platelet Count ≥ 20 x 10^9/L Above Baseline for Two Consecutive Weeks|Participant incidence of achieving an increase in platelet count ≥20 x 10^9/L above baseline for two consecutive weeks during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants|||Participants|||Number
1249634|NCT00515203|Secondary|Platelet Count ≥ 50 x 10^9/L for Two Consecutive Weeks|Participant incidence of achieving a platelet count ≥50 x 10^9/L for two consecutive weeks during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants|||Participants|||Number
1249635|NCT00515203|Secondary|Bleeding Events (Grade 2 or Higher)|Total number of bleeding events (Grade 2 or higher, i.e., mild to life-threatening, as defined in the protocol) for each participant during Weeks 2-13 (end-of-study visit for non-responders)|12-week treatment period (Weeks 2 - 13)|Efficacy Analysis Set, composed of all randomized participants|||Events per participant||Standard Deviation|Mean
1249636|NCT00515203|Secondary|Weeks With Platelet Count ≥ 50 x 10^9/L|The number of weeks with platelet count ≥ 50 x 10^9/L during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants|||Weeks||Standard Deviation|Mean
1249637|NCT00515177|Secondary|Medical Outcome Study Short Form (SF-12)|Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
1249638|NCT00515177|Secondary|Center for Epidemiological Studies Depression Scale (CES-D)|The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
1249639|NCT00515177|Secondary|State-Trait Anxiety Inventory (STAI)|The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
1249640|NCT00515177|Primary|Actigraphy|Total Sleep Time from Actigraphy|8 weeks|In the PCT arm, one person who refused to take the drug and one who did not complete actigraphy were excluded. 10-2=8 In the MBSR arm, one person who did not attend MBSR, one person who attended fewer than 5 classes, and two who did not complete actigraphy were excluded. 20-4=16.|||hours||Standard Deviation|Mean
1249641|NCT00515177|Primary|Insomnia Severity Index|The Insomnia Severity Index is a 7-item scale that provides a total score indicating current (e.g., last 2 weeks) severity of insomnia symptoms with scores that can range from 0 to 28. Scores of 15 or higher indicate clinical insomnia.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
1249642|NCT00515177|Primary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
1249643|NCT00515112|Secondary|To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.|The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.|every 8 weeks|||||||
1249644|NCT00515112|Primary|Progression Free Survival|Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.|Up to 5 years|This study has been terminated due to poor accrual.||||||
1249645|NCT00515099|Secondary|Hemoglobin A1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c of <\=5.6% is considered normal. HbA1c of 6.5% or higher is typical for individuals with Type 1 Diabetes mellitus (T1DM).|Baseline (Pre-treatment), Months 12 and 24|Intent-to-treat|||Percentage (%)||Standard Deviation|Mean
1249646|NCT00515099|Secondary|2-Hour and 4-Hour C-peptide Area Under the Curve (AUC) Results in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) and 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the CDER at the FDA as a valid efficacy endpoint.|Baseline (Pre-treatment), Month 24|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
1249647|NCT00515099|Secondary|Number of Participants With Major Hypoglycemic Event(s) Post Treatment Randomization/Initiation|Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.|Baseline (Pre-treatment), Months 12 , and 24|Intent-to-treat|||participants|||Number
1249648|NCT00515099|Secondary|Number of Participants Who Are Exogenous-Insulin-Free|The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment), Months 12 , 18, and 24|Intent-to-treat|||participants|||Number
1249649|NCT00515099|Secondary|Insulin Use in Units Per Kilogram Body Weight Per Day|The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment), Months 12 and 24|Intent-to-treat|||units/day/kg||Standard Deviation|Mean
1249650|NCT00515099|Secondary|4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy endpoint.|Baseline (Pre-treatment initiation), Month 12|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
1249651|NCT00515099|Primary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Month 12|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
1249652|NCT00515086|Secondary|Surgery Group: Number of Participants With Adverse Events|The number of participants with any adverse event by System Organ Class. Additional information about Adverse Events can be found in the Adverse Event Section.|First day of treatment to study discontinuation (Up to 28 weeks)|Surgery Group participants from the Safety population who received at least one dose of study medication.|||Participants|||Number
1249653|NCT00515086|Secondary|No Surgery Group: Progression Free Survival|Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS is reported for participants with 1 previous relapse and participants with ≥2 previous relapses. PFS was measured from the first day of treatment to disease progression or death and is derived using the Kaplan-Meier method.|First day of treatment to study discontinuation (up to 60 weeks)|No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication.|||Weeks||95% Confidence Interval|Median
1249654|NCT00515086|Secondary|Surgery Group: Biomarkers Phosphatase and Tensin Homolog (PTEN) and Epidermal Growth Factor Receptor (EGFR)|"The secondary efficacy assessment was to evaluate the role of PTEN and EGFR pathway status on phosphor-S6. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. Immunohistochemistry and Fluorescence in-situ hybridization (FISH) were used to assess PTEN and EGFR pathway status.~Study was terminated due to slow enrollment. Analysis was not possible due to insufficient sample size."|After surgery, week 4, week 8 and every 8 weeks thereafter|Study was terminated due to slow enrollment.|||Levels||Standard Deviation|Mean
1249655|NCT00515086|Secondary|Surgery Group: Progression-free Survival|Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS was measured from the first day of treatment after surgery to disease progression or death and is derived using the Kaplan-Meier method.|After surgery (within 96 hours), Weeks 4 and 8 and then every 8 weeks after restarting treatment until study discontinuation (Up to 28 weeks)|Results for the Surgery Group only include patients with residual tumor following salvage surgery.|||Weeks||95% Confidence Interval|Median
1249656|NCT00515086|Secondary|Surgery Group: Blood and Brain Tissue Levels of Everolimus (RAD001)||Baseline and Day 7-9 (Blood samples were collected one day prior to surgery and tissue samples were collected during surgery.)|Study was terminated due to slow enrollment.|||Levels||Standard Deviation|Mean
1249657|NCT00515086|Primary|No Surgery Group: Best Overall Tumor Response|The best overall tumor response is reported for participants with 1 previous relapse and participants with ≥2 previous relapses according to the following categories: Complete Response, Partial Response, Stable Disease and Progressive Disease. Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) was used for tumor analysis. The objective assessment of tumor response was evaluated at each site by the designated pathologist based on the Neuro-Oncology criteria for Tumor Response for Central Nervous System (CNS) tumors.|First day of treatment to study discontinuation (up to 60 weeks)|No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication.|||Participants|||Number
1249658|NCT00515086|Primary|Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels|In the Surgery Group, the primary efficacy assessment was inhibition of Mammalian target of rapamycin (mTOR) as defined as ≥75% S6 phosphorylation. The occurrence of S6 phosphorylation was determined by phosphor-S6 immunohistochemical staining. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments.|Baseline and Day 7-9 (during salvage surgery)|Study was terminated due to slow enrollment.|||Percentage change in S6 kinase|||Number
1249659|NCT00515073|Primary|Overall Survival at 2 Years and 5 Years|The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.|Assessment at 2 years and 5 years|Two participants were inevaluable.|||percentage of participants|||Number
1249660|NCT00515034|Secondary|Patients With cIAI Who Were Clinically Cured|clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.|7 to 14 days after the end of IV therapy|participants who were clinically evaluable|||participants|||Number
1249661|NCT00515034|Secondary|Patients With VAP Who Were Clinically Cured|clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.|7 to 14 days after the end of IV therapy|the population is the number of participants who are clinically evaluable|||participants|||Number
1249662|NCT00515034|Primary|Patients With Incidence of Treatment-emergent Adverse Events (TEAEs).|Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.|from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy|population is the as-treated analysis set - that is subjects who were administered therapy|||participants|||Number
1249663|NCT00515008|Secondary|Mean Change From Baseline CPSS Score|The Chronic Pain Self-Efficacy Scale (CPSS) is a self-report score measuring self-efficacy with respect to chronic pain (range, 1 to 10, with higher scores indicating greater self-efficacy).|12 weeks||||units on a scale||95% Confidence Interval|Mean
1249664|NCT00515008|Secondary|Mean Change From Baseline CES-D Score|The Center for Epidemiologic Studies (CES-D) Depression Scale (range, 0 to 60, with higher scores indicating more severe depression), is a self-report measure of depressive symptoms.|12 weeks||||units on a scale||95% Confidence Interval|Mean
1249665|NCT00515008|Secondary|Mean Change From Baseline SF-36 Score Mental Component|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|12 weeks||||units on a scale||95% Confidence Interval|Mean
1249666|NCT00515008|Secondary|Mean Change From Baseline SF-36 Score Physical Component|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|12 weeks||||units on a scale||95% Confidence Interval|Mean
1249667|NCT00515008|Secondary|Mean Change From Baseline of 6-Minute Walk Test||12 weeks||||yards||95% Confidence Interval|Mean
1249668|NCT00515008|Secondary|Mean Change From Baseline PSQI Score|The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep quality(range, 0 to 21, with higher scores indicating worse sleep quality)|12 weeks||||units on a scale||95% Confidence Interval|Mean
1249669|NCT00515008|Secondary|Mean Change From Baseline of Patient’s Global Assessment Score|Patients' global assessment score was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|12 weeks||||units on a scale||95% Confidence Interval|Mean
1249670|NCT00515008|Secondary|Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity|Physicians' global assessment score was assessed separately by the study physician, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|Wks 12||||units on a scale||95% Confidence Interval|Mean
1249671|NCT00515008|Primary|Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score|Fibromyalgia Impact Questionnaire (FIQ) is a well-validated, multidimensional measure of the overall severity of fibromyalgia as rated by patients. Categories include the intensity of pain, physical functioning, fatigue, morning tiredness, stiffness, depression, anxiety, job difficulty, and overall well-being.21 The total score ranges from 0 to 100, with higher scores indicating more severe symptoms.|wks 12||||units on a scale||95% Confidence Interval|Mean
1249672|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Pharmacokinetic Set (PK)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1249673|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29)|"Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.~Note: At day 29, values for afatinib 40 mg no values reported in stage 2."|Day 29|Pharmacokinetic Set (PK)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1249674|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15)|"Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.~Note: At day 15, values for afatinib 40 mg no values reported in stage 1 and stage 2."|Day 15|Pharmacokinetic Set (PK): The PK analysis was based on all patients who were treated with afatinib and who had evaluable plasma concentration data, which consisted of data for 60 patients in Stage 1 and 35 patients in Stage 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1249675|NCT00514943|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First administration of trial medication until 28 days after last drug administration|Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.|||percentage of participants|||Number
1249676|NCT00514943|Secondary|Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function|"Patients with adverse events (AEs) resulting in Diarrhea, Skin Rash, dose reduction, treatment discontinuation and decreased cardiac left ventricular function~Note: To asses the Decreased Cardiac left ventricular function, Left ventricular ejection fraction (LVEF) was assessed in patients treated with afatinib in Stage 1 and Stage 2 . And no patients in either group had a significant change in LVEF during Stage 1 or Stage 2 of the trial."|First administration of trial medication until 28 days after last drug administration|Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.|||number of participants|||Number
1249753|NCT00514683|Secondary|Change From Baseline in RV|Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
1249677|NCT00514943|Secondary|Time to Deterioration in HRQoL - Stage 1|"Health related Quality of Life (HRQoL) for Time to deterioration was assessed using the the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Head and Neck Cancer Module (H&N35).~Time to deterioration in HRQoL (defined as a 10-point change towards worsening from the baseline score on a 0-100 point scale) was determined for:~global health status (Questions 29 and 30 in EORTC QLQ C30)~pain (Questions 9 and 19 in EORTC QLQ C30)~swallowing (Questions 35 to 38 in EORTC QLQ-H&N35)"|From randomisation to deterioration in HRQoL scores before crossover.|Randomised Set (RS)|||months||95% Confidence Interval|Median
1249678|NCT00514943|Secondary|Overall Survival (OS)|"OS is defined as time from randomisation to death.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From randomisation to data cut-off date.|Randomised set (RS).|||Weeks||95% Confidence Interval|Median
1249679|NCT00514943|Secondary|Progression Free Survival (PFS) After Crossover Based on Investigator Assessment|"PFS is defined as time from first administration study medication after cross over until the occurrence of tumor progression or death, whichever came first, during Stage 2 of the trial.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover.|Patients treated in stage 2|||weeks||95% Confidence Interval|Median
1249680|NCT00514943|Secondary|Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment|"PFS is defined as time from randomisation to until the occurrence of tumor progression or death, whichever occurred first, during Stage 1 of the trial.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover.|Randomised set (RS).|||weeks||95% Confidence Interval|Median
1249681|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2|Best RECIST Assessment as confirmed duration of disease control as per the independent central review (ICR) assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|patients treated in stage 2|||Weeks||Standard Deviation|Mean
1249682|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2|Best RECIST Assessment as confirmed duration of objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|patients treated in stage 2|||Weeks||Standard Deviation|Mean
1249683|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1|Best RECIST Assessment as duration of confirmed objective response and disease control as per the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised Set (RS)|||Weeks||Standard Deviation|Mean
1249684|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1|Best RECIST Assessment as duration of confirmed objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised Set (RS)|||Weeks||Standard Deviation|Mean
1249685|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2|Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2|||Number of participants|||Number
1249686|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1|Best RECIST Assessment as onset of confirmed objective response as per the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).|||Number of participants|||Number
1249687|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1|Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment for Stage 1.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).|||Number of participants|||Number
1249688|NCT00514943|Secondary|Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2|||Number of participants|||Number
1249689|NCT00514943|Secondary|Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2|||Number of participants|||Number
1249690|NCT00514943|Secondary|Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).|||Number of participants|||Number
1249754|NCT00514683|Secondary|Change From Baseline in TLC|Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
1249691|NCT00514943|Secondary|Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).|||Number of participants|||Number
1249692|NCT00514943|Secondary|Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments|Tumor shrinkage after crossover was defined as the change from baseline in the smallest post-crossover sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after crossover minus SLD at baseline. Baseline was the SLD measured at the time of crossover, or the closest measurement before the patient started stage 2 treatment. A negative value means the smallest post-crossover SLD was smaller than baseline (decreased after crossover), a positive value means tumor size increased after crossover.|From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment.|Patients treated in stage 2 : This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.|||millimeters||Standard Deviation|Mean
1249693|NCT00514943|Primary|Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment|"Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.~Mean calculated is actually the Adjusted mean. Adjusted mean is obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions as covariates."|From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1.|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment, whether treated or not. However, patients without baseline or post-baseline tumor measurements were excluded.|||millimeter||Standard Error|Mean
1249694|NCT00514917|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAE: any adverse event (AE) that occurred or worsened during the on-treatment period, which was the period from first administration of study treatment until 30 days after last administration of study treatment. AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly, or medically important. Drug-related AEs were any untoward medical occurrences attributed to study drug in a participant who received study drug. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 Grade 3 (severe) and Grade 4 (life threatening/disabling) TEAEs were also reported.|From first administration of study treatment until 30 days after the last administration of study treatment|Safety population included all randomized participants who received at least part of one dose of any of the study drugs.|||participants|||Number
1249695|NCT00514917|Secondary|Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT|EF-IIEF is a 6-item erectile function domain of IIEF. It consists of Question 1, 2, 3, 4, 5, and 15 of IIEF questionnaire. 5 questions are scored from 0 (no activity) to 5 (very high activity) and 1 question is scored from 1 (very low activity) to 5 (very high activity). Total EF-IIEF score ranges from 1 to 30, where higher score indicates high activity.|Baseline, EOT (up to Month 18)|"ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively."|||units on a scale||Standard Deviation|Mean
1249696|NCT00514917|Primary|Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population|PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.|Month 36|Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following completion of treatment of leuprolide with at least 1 follow-up PSA assessment.|||percent chance of being progression-free||95% Confidence Interval|Number
1249697|NCT00514917|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT|MAF scale consists of 16-items to measure 4 dimensions of fatigue during past week: severity (Item 1-2), distress (Item 3), degree of interference in activities of daily living (Item 4-14), and timing (Item 15-16). Item 1-14 are scored on a numeric rating scale from 1 to 10, where higher score indicate more severity/distress/interference. Item 15-16 had multiple choice responses (4 responses each). Scale Index was calculated using Item 1-15, in following steps: 1) Item 15 score converted to 1-10 scale by multiplying the score with 2.5; 2) Average score was calculated from Item 4-14; 3) Finally scale index was calculated by adding Items 1, 2, 3 scores with average score from step 2 and converted score of Item 15 from step 1. Total MAF scale index score ranges 1 (no fatigue) to 50 (severe fatigue).|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Deviation|Mean
1249698|NCT00514917|Primary|Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population|PFS was the time from randomization to the date of first documented PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.|Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60|Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following the completion of treatment of leuprolide with at least 1 follow-up PSA assessment.|||months||95% Confidence Interval|Median
1249699|NCT00514917|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT|Physical well-being, functional well-being, and prostate cancer concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Deviation|Mean
1249700|NCT00514917|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT)|FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. A score of 156 represents the best outcome.|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Deviation|Mean
1249701|NCT00514917|Secondary|Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific)|The cancer-specific survival was the time from the date of randomization to the date of death due to prostate cancer. Cancer-specific survival was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from prostate cancer.|Randomization until death due to prostate cancer, assessed up to Month 60|ITT population.|||participants|||Number
1249702|NCT00514917|Secondary|Overall Survival (OS): Number of Participants Who Died (All Cause)|The OS was the time interval from the date of randomization to the date of death due to any cause. OS was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from any cause.|Randomization until death due to any cause, assessed up to Month 60|ITT population.|||participants|||Number
1249703|NCT00514917|Primary|Progression-Free Survival (PFS) Rate at Month 36 in ITT Population|PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.|Month 36|ITT population.|||percent chance of being progression-free||95% Confidence Interval|Number
1249704|NCT00514917|Primary|Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population|PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram per millimeter [ng/mL]), which was confirmed by consecutive observation (not less than 2 weeks apart). Median PFS was estimated using the Kaplan-Meier method.|Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60|ITT population included all participants who were randomized, with study drug assignment designated according to randomization, regardless of whether participants received any study drug or a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1249705|NCT00514904|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.|From Day 0 up to 6 months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1249706|NCT00514904|Secondary|Number of Subjects Reporting Any Unsolicited Symptoms|Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Up to one month (Day 0-Day 30) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1249707|NCT00514904|Secondary|Number of Subjects Reporting Specific Adverse Events (AEs)|Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits.|From Day 0 up to 6 months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1249708|NCT00514904|Secondary|Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.|||Participants|||Count of Participants
1249709|NCT00514904|Secondary|Number of Subjects < 6 Years of Age With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.|||Participants|||Count of Participants
1249710|NCT00514904|Secondary|Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.|||Participants|||Count of Participants
1249711|NCT00514904|Secondary|Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.|||Participants|||Count of Participants
1249712|NCT00514904|Secondary|Anti-polysaccharide (Anti-PS) Antibody Concentrations|Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1249713|NCT00514904|Secondary|Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values|The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.|Pre vaccination (Month 0) and post vaccination, (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1249714|NCT00514904|Secondary|Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations (GMCs)|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1249715|NCT00514904|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values|The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1249716|NCT00514904|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were expressed as geometric mean titers (GMTs).|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1249717|NCT00514904|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values|The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1249718|NCT00514904|Primary|Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)|Grade 3 symptom was defined as symptom that prevented normal, everyday activities.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1249719|NCT00514904|Primary|Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135|Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).|One month after vaccination (Post-vaccination, study Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1249720|NCT00514852|Secondary|Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score|Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)|Change from baseline at Day 30|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
1249721|NCT00514852|Secondary|Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein|Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)|Change from baseline at Day 30|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
1249722|NCT00514852|Secondary|Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein|Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)|Change from baseline at Day 30|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
1249723|NCT00514852|Post-Hoc|Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30|Central staining score is based on modified Oxford Scheme measured on a scale of 0-5 (0= no staining, 5= most severe staining)|Day 30|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
1249724|NCT00514852|Post-Hoc|Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30|Vision subscale of the Ocular Surface Disease Index Questionnaire© is measured on 6 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)|Day 30|Intent to Treat Population (Modified)|||Units on a scale||Standard Deviation|Mean
1249725|NCT00514852|Secondary|Patient Acceptability Score (Vision) at Day 30|Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).|Day 30|Intent to treat population|||Units on a scale||Standard Deviation|Mean
1249726|NCT00514852|Secondary|Patient Acceptability Score (Dryness) at Day 30|Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).|Day 30|Intent to Treat Population|||Units on scale||Standard Deviation|Mean
1249727|NCT00514852|Secondary|Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein|Measures the stability of tear film. The average of 3 measures.|Change from baseline at Day 30|Intent to Treat Population|||seconds||Standard Deviation|Mean
1249728|NCT00514852|Secondary|Change From Baseline at Day 30 in Schirmer Test, With Anesthesia|Schirmer Test measures the rate of the secretion of tears|Change from baseline at Day 30|Intent to Treat Population|||mm/5min||Standard Deviation|Mean
1249729|NCT00514852|Primary|Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score|Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)|Change from baseline at Day 30|Intent to Treat Population (Modified)|||Units on a scale||Standard Deviation|Mean
1249730|NCT00514813|Secondary|Change From Baseline in Hematocrits at 2 Years||Baseline and 2 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.||||||
1249731|NCT00514813|Secondary|Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years||Baseline and 2 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.||||||
1249732|NCT00514813|Primary|Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)||Over the course of 2 Years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.||||||
1249733|NCT00514735|Secondary|Improved Quality of Life Over 6 Months Compared to Baseline.|The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.|||Scores on a scale||Standard Deviation|Mean
1249734|NCT00514735|Secondary|Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.|The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.|||AF Symptom Severity Score||Standard Deviation|Mean
1249735|NCT00514735|Secondary|Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.|Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.|||percent||Standard Deviation|Mean
1249736|NCT00514735|Secondary|Improvement of Left Atrial Size at 6 Months Compared to Baseline.|Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.|||centimeters||Standard Deviation|Mean
1249737|NCT00514735|Secondary|Acute Efficacy|"A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:~Medtronic ablation catheters were used to achieve procedure success.~All accessible pulmonary veins were isolated.~At least 50% reduction of complex fractionated atrial electrograms mapped and ablated with Medtronic ablation catheters.~Sinus rhythm was achieved upon leaving the electrophysiology lab (±cardioversion)."|Procedure conclusion|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.|||percentage of participants||95% Confidence Interval|Mean
1249738|NCT00514735|Primary|Chronic Safety|The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.|||participants|||Number
1249739|NCT00514735|Primary|Acute Safety|The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.|7 days|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.|||percentage of participants||95% Confidence Interval|Mean
1249740|NCT00514735|Primary|Chronic Effectiveness|"The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:~A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes.~The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only)~The Investigator judged all procedures to be acutely successful (Ablation Management arm only)."|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.|||percentage of participants with success|||Number
1249741|NCT00514709|Secondary|Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.~Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 after vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.|||Participants|||Number
1249742|NCT00514709|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)|Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in a sub-set of the participants available for the endpoint, the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1249743|NCT00514709|Primary|Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.~Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response."|Day 0 (pre-vaccination) and Day 28 post-booster vaccination|Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.|||Participants|||Number
1249744|NCT00514683|Secondary|Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).|Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it.|day 365 and day 729|Randomised set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1249745|NCT00514683|Secondary|Time to Progression|"Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) >= 10%) or Death.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC - Randomised set|||Days||95% Confidence Interval|Median
1249746|NCT00514683|Secondary|Survival (Death Due to Respiratory Cause, and Lung-transplant Free)|"Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set|||percentage of participants|||Number
1249747|NCT00514683|Secondary|Time to First Occurrence of IPF Exacerbation|"This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set|||percentage of participants|||Number
1249748|NCT00514683|Secondary|Occurrences of IPF Exacerbations Per Patient Per Year|Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks|52 weeks|OC-Randomised set|||Exacerbations Per Year||Standard Deviation|Mean
1249749|NCT00514683|Secondary|Number of Patients With at Least One IPF Exacerbation|Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks|52 weeks|OC-Randomised set|||participants|||Number
1249750|NCT00514683|Secondary|Change From Baseline in IC|Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
1249751|NCT00514683|Secondary|Change From Baseline in VC|Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
1249752|NCT00514683|Secondary|Change From Baseline in TGV|Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
1249755|NCT00514683|Secondary|St George's Respiratory Questionnaire (SGRQ) Responder|St George's Respiratory Questionnaire (SGRQ) responder (<= -4 points change) (%) at 52 weeks-worst case|52 weeks|Worst case - Randomised set|||percentage of participants|||Number
1249756|NCT00514683|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||units on a scale||Standard Error|Mean
1249757|NCT00514683|Secondary|Change From Baseline in SGRQ Domain Score Impacts|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF - Randomised set|||units on a scale||Standard Error|Mean
1249758|NCT00514683|Secondary|Change From Baseline in SGRQ Domain Score Symptoms|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||units on a scale||Standard Error|Mean
1249759|NCT00514683|Secondary|Change From Baseline in SGRQ Total Score|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||units on a scale||Standard Error|Mean
1249760|NCT00514683|Secondary|Absolute Change From Baseline in FEV1/FVC|"Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||percentage of FVC||Standard Error|Mean
1249761|NCT00514683|Secondary|Absolute Change From Baseline in MRC Dyspnea Scale by Categories|"Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories:~Decrease~No Change~Increase"|Baseline and 52 weeks|LOCF- Randomised|||percentage of participants|||Number
1249762|NCT00514683|Secondary|Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)|"Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :~0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).~The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||Units on a scale||Standard Error|Mean
1249763|NCT00514683|Secondary|Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)|"Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :~0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).~The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||Units on a scale||Standard Error|Mean
1249764|NCT00514683|Secondary|Absolute Change From Baseline in Distance Walk (6-MWT)|Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Meter||Standard Error|Mean
1249765|NCT00514683|Secondary|Absolute Change From Baseline in DLCO by Categories|"Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories:~Decrease > 15% or > 1~Change <= 15% or <= 1~Increase > 15% or > 1"|Baseline and 52 weeks|LOCF Randomized set|||percentage of patients|||Number
1249766|NCT00514683|Secondary|Absolute Change From Baseline in DLCO|"Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||mmol.min^−1.kPa^−1||Standard Error|Mean
1249767|NCT00514683|Secondary|Absolute Change From Baseline in P(A-a) O2 by Categories|"Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories:~Decrease > 4 mmHg~Change within +/- 4 mmHg~Increase > 4 mmHg"|Baseline and 52 weeks|OC - Randomised set|||percentage of participants|||Number
1249768|NCT00514683|Secondary|Absolute Change From Baseline in PaO2 by Categories|"Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories:~Decrease > 4 mmHg~Change within +/- 4 mmHg~Increase > 4 mmHg"|Baseline and 52 weeks|OC - Randomised set|||percentage of participants|||Number
1249769|NCT00514683|Secondary|Absolute Change From Baseline in PaCO2|Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set|||mmHg||Standard Error|Mean
1249770|NCT00514683|Secondary|Absolute Change From Baseline in P(A-a)O2|Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set|||mmHg||Standard Error|Mean
1249771|NCT00514683|Secondary|Absolute Change From Baseline in PaO2|Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set|||mmHg||Standard Error|Mean
1249772|NCT00514683|Secondary|Absolute Change From Baseline in SpO2 at Rest by Categories|"Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories:~SpO2 (non-invasive) at 52 weeks:~Decrease > 4% SpO2~Change within +/- 4% SpO2~Increase > 4% SpO2"|Baseline and 52 weeks|LOCF-Randomised set|||percentage of participants|||Number
1249773|NCT00514683|Secondary|Absolute Change From Baseline in SpO2 at Rest|"Absolute change from baseline in oxygen saturation (SpO2) at rest.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||Percentage of SpO2||Standard Error|Mean
1249774|NCT00514683|Secondary|Survival (All Causes of Death and Lung-transplant Free)|"Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set|||participants|||Number
1249775|NCT00514683|Secondary|Number of Participants With Change From Baseline in FVC by Categories|"Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories:~Decrease > 10% or 200mL~Change within <= 10% or <=200 mL~Increase > 10% or 200mL"|Baseline and 52 weeks|LOCF-Randomised set|||participants|||Number
1249776|NCT00514683|Secondary|Relative Change From Baseline in FVC|"Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region"|Baseline and 52 weeks|LOCF-Randomised set|||percentage change||Standard Error|Mean
1249777|NCT00514683|Secondary|Relative Change From Baseline in FVC%Pred|"Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|LOCF-Randomised set|||percentage of change||Standard Error|Mean
1249778|NCT00514683|Secondary|Absolute Change From Baseline in FVC|"Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
1249779|NCT00514683|Secondary|Absolute Change From Baseline in FVC%Pred|"Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|"Last Observation Carried Forward (LOCF): This method was used for the replacement of missing values.~Randomised set: This patient set includes all randomised patients whether treated or not."|||percentage of predicted FVC||Standard Error|Mean
1249780|NCT00514683|Primary|Rate of Decline in FVC|"Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment.~The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time."|Baseline until 52 weeks|"Observed Case (OC): This method was used for the replacement of missing values.~Randomised set: This patient set includes all randomised patients whether treated or not."|||Liters/year||Standard Error|Mean
1249781|NCT00514592|Secondary|Any Stroke Before Carotid Enderarterectomy|Same as primary endpoint, but includes stroke of all types.|Before CEA||||participants|||Number
1249782|NCT00514592|Primary|Ipsilateral Ischemic Stroke Before Carotid Endarterectomy|Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.|Before CEA||||participants|||Number
1249783|NCT00514514|Secondary|Efficacy Event Data After Month 12 to Month 60|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|Events starting after Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.|||Participants|||Number
1249784|NCT00514514|Secondary|Mean Change in Serum Creatinine From Month 3 to Month 60|Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed were previously enrolled in the core study and had at least one serum creatinine value in the extension period.|||mg/dl||95% Confidence Interval|Least Squares Mean
1249785|NCT00514514|Secondary|GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method|"Change in GFR (Modification of Diet in Renal Disease calculated using the –MDRD formulat:~For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate."|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
1249786|NCT00514514|Secondary|GFR at Month 60 Utilizing Cockcroft-Gault Formula|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl) For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
1249807|NCT00514137|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|From the documentation of response until the date of progression|No analysis was done because there were no confirmed responses.||||||
1249808|NCT00514137|Secondary|Event-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
1249787|NCT00514514|Secondary|GFR Calculated Via Nankivell Formula at Month 60|Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.|From randomization at BL2 (Month 3) to Month 60|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
1249788|NCT00514514|Secondary|Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)|The Framingham Score (based on LDL cholesterol level) estimates the coronary heart disease risk (%) of developing one of the following coronary heart diseases: angina pectoris, myocardial infarction, or coronary disease death, over the course of 10 years.|From Baseline 2 (Month 3) to Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.|||Percent risk||Standard Deviation|Mean
1249789|NCT00514514|Secondary|Efficacy Event Data Baseline 2 (Month 3) to Month 12|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|From Baseline 2 (Month 3) to Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.|||Participants|||Number
1249790|NCT00514514|Secondary|Efficacy Event Data From Baseline 2 (Month 3) to Month 6|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|From Baseline 2 (Month 3) to Month 6|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.|||Participants|||Number
1249791|NCT00514514|Secondary|Mean Change in Serum Creatinine From Month 3 to Month 12|Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed required at least one post randomization value. ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization|||mg/dl||95% Confidence Interval|Least Squares Mean
1249792|NCT00514514|Secondary|GFR at Month 12 Utilizing Cockcroft-Gault Formula|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
1249793|NCT00514514|Secondary|GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method|"Change in GFR (Modification of Diet in Renal Disease calculated using the –MDRD formulat:~For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate."|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
1249794|NCT00514514|Secondary|GFR Via Nankivell Formula at Month 12 - All Regimens|Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
1249843|NCT00513526|Secondary|Longitudinal Changes in CD4+ Cell Count From Baseline|CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.|Week 0, 4, 12, 28|Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.|||cells/uL||Inter-Quartile Range|Median
1249795|NCT00514514|Primary|GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen|Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
1249796|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.|||% (n/N)||95% Confidence Interval|Number
1249797|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.|||% (n/N)||95% Confidence Interval|Number
1249798|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.|||% (n/N)||95% Confidence Interval|Number
1249799|NCT00514449|Secondary|Changes in Grey Matter Deficit|Gray matter volume changes (in cc) were measured using structural MRI. Changes were reported as gray matter volume in cc. Note: Assessment of blood oxygenation level dependent (BOLD) changes using fMRI were erroneously included in the original study record.|Baseline, Week 18|Analysis included on all participants on whom baseline and week 18 data were collected. Valacyclovir and placebo groups|||cm^3||Standard Deviation|Mean
1249800|NCT00514449|Primary|Cognitive Function Neuropsychological Battery (Gur Battery)|All results are given as the mean difference between an 18 week follow-up and the baseline battery administrations.This is a computerized test that measures both accuracy and response times. A range for response times is not available because of individual variabilities. Accuracy scores can vary for each test: Working memory accuracy range was 0-16. Verbal memory accuracy range was 0-20. For both, the higher the score the better. No cut offs are available|Baseline, Week 18||||units on a scale||Standard Deviation|Mean
1249801|NCT00514449|Primary|PANSS Positive and Negative Syndrome Scale for Schizophrenia|This is a structured measure of severity of psychopathology that includes both positive and negative symptoms. The range is a minimum score of 30 and the maximum is 210. The lower scores suggest milder severity of illness domains.|Baseline, Weeks 2, 4, 6, 10, 14, 18|Comparative analysis of active drug versus placebo|||Scores on the scale||Standard Deviation|Mean
1249802|NCT00514215|Secondary|Immune Function and Cancer-specific Response|CT-guided biopsy & Peritumoral GM-CSF|Days 1 & 32|||||||
1249803|NCT00514215|Secondary|Toxicity|CBC, sodium, potassium, BUN, serum creatinine, calcium, glucose, SGOT, Alk Phos, bilirubin, Electrolytes, Albumin (Alb), Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Total bilirubin (TBIL), Direct bilirubin (Conjugated Bilirubin), Gamma glutamyl transpeptidase (GGT)|Days 11, 32, 43, & 63|||||||
1249804|NCT00514215|Secondary|Clinical Response as Measured by CT Criteria|CT-guided biopsy|Days 1 & 32|||||||
1249805|NCT00514215|Primary|Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry|CT-guided biopsy & Peritumoral GM-CSF|Days 1 & 32|Patients who had metastatic Renal Cell carcinoma|||percentage of participants||90% Confidence Interval|Number
1249806|NCT00514137|Secondary|Toxicity|Assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Included are the toxicities at least possibly related to the study drug.|From the time of first treatment to up to 30 days after the last day of study drug treatment||||participants|||Number
1249809|NCT00514137|Primary|The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])|"A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart.~A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis.~A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas.~A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma."|Every 6 weeks from the first initiation of therapy up to 72 weeks|All 13 participants were evaluable for a response|||participants|||Number
1249810|NCT00514020|Primary|"Number of Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])"|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.|every 8 weeks to progression|"Patients available for measurement of response. All patients who received Oxaliplatin + Leucovorin + 5-Fluorouracil are in the heterozygous good risk genotype group. One patient was not evaluable for response."|||participants|||Number
1249811|NCT00513799|Secondary|Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.|4 month follow-up||||Participants|||Number
1249812|NCT00513799|Secondary|Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection|Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.|1, 4 and 6 month follow-ups|Groups 1/4 have 1 more participant analyzed each than in participant flow module due to data collected by phone. They did not return to hospital for followup (colonization swabs were not obtained). Group 3 has 1 less participant analyzed than in participant flow module due to missing data point on followup survey. They were not able to be reached.|||Participants|||Number
1249813|NCT00513799|Primary|Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.|1 month follow-up||||Participants|||Number
1249814|NCT00513708|Secondary|Completed Inpatient Treatment|"Completion of inpatient treatment was defined as being admitted to and successfully discharged from an inpatient alcohol treatment program (e.g., a 28-day program). Participants who left the inpatient program against medical advice or who received an administrative discharge were not considered to have successfully completed the inpatient program."|90 days|"There were 50 participants in each arm; the number of participants analyzed represents the number of those 50 in each arm who were admitted to an inpatient treatment program (e.g., a 28-day program)."|||Participants|||Number
1249815|NCT00513708|Secondary|Relapse to Drinking|"Relapse to drinking was defined as the consumption of one or more standard drinks (approximately 12 grams of ethanol)during the first 30 days following discharge from the inpatient detoxification unit. The date of discharge was considered to be Day 1."|30 days|"There were 50 participants in each arm. Per protocol, the number of participants analyzed represents the number that had outcome data (i.e, relapse or no relapse) available at the 30-day follow-up."|||participants|||Number
1249816|NCT00513708|Primary|"Linkage to Alcohol Behavioral Therapy Counseling (i.e., Aftercare)"|"Linkage to alcohol behavioral therapy counseling (i.e., aftercare) was defined as: arriving for the first outpatient chemical dependency counseling visit, being admitted to an inpatient or residential chemical dependency treatment facility, or attending at least one meeting of a help-help program such as Alcoholics Anonymous."|1 month|"There were 50 participants in each arm. Per protocol, the number of participants analyzed represents the number that had outcome data (i.e, linked to aftercare or not linked to aftercare) available at the 30-day follow-up."|||participants|||Number
1249817|NCT00513695|Secondary|Number and Percent of Subjects Reporting Adverse Events|See Adverse Events section for more details.|28 days after the last dose of study drug||||Participants|||Count of Participants
1249818|NCT00513695|Secondary|Overall Survival|Kaplan-Meier estimate from the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive, assessed at two years.|Up to 2 years||||survival probability||95% Confidence Interval|Number
1249819|NCT00513695|Secondary|Time to Disease Progression|Median time to disease progression, at two years, as defined by clear increase in disease sites present at registration or development of new disease sites.|Up to 2 years||||days||95% Confidence Interval|Median
1249820|NCT00513695|Secondary|Relapse Rate|Cumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk.|Up to two years||||probability of relapse||95% Confidence Interval|Number
1249821|NCT00513695|Secondary|Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels||At baseline, after week 12 of therapy, and prior to surgery|Data not collected||||||
1249822|NCT00513695|Primary|Microscopic Pathologic CR (pCR) Rate|Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.|At the time of surgery||||percent of evaluable participants||95% Confidence Interval|Number
1249844|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.|||proportion of participants||95% Confidence Interval|Number
1249823|NCT00513682|Secondary|Percent Coefficient of Nitrogen Absorption (CNA)|Percent CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72- hour period in either washout phase or treatment phase. Nitrogen intake was calculated as protein intake/6.25. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.|Day 3 to Day 5 or Day 6 during washout phase and treatment phase|Intent-to-treat (ITT) population included all the participants who took at least 1 dose of Ultrase® MT20 and had completed at least 1 phase (washout or treatment phase) evaluating primary and secondary efficacy parameters.|||Percent CNA||Standard Deviation|Mean
1249824|NCT00513682|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period in either washout phase or treatment phase. Mean percent CFA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.|Day 3 to Day 5 or Day 6 during washout phase and treatment phase|Intent-to-treat (ITT) population included all the participants who took at least 1 dose of Ultrase® MT20 and had completed at least 1 phase (washout or treatment phase) evaluating primary and secondary efficacy parameters.|||Percent CFA||Standard Deviation|Mean
1249825|NCT00513617|Secondary|Fetal Hemoglobin|Fetal hemoglobin (HbF) as measured by the Advia machine|12 weeks after randomization|||||||
1249826|NCT00513617|Secondary|Endothelin-1|Endothelin-1 is a potent vasoconstrictor and pro-inflammatory agent which is elevated in SCD patients|12 weeks after randomization|||||||
1249827|NCT00513617|Secondary|8-iso-PGF2a|8-iso-PGF2a is a measure of lipid peroxidation and oxidative damage in vivo measured by enzyme immunoassay kit from Cayman chemical|12 weeks after randomization|||||||
1249828|NCT00513617|Primary|Mean Corpuscular Hemoglobin Concentration|Mean corpuscular hemoglobin concentration as measured by an Advia machine|12 weeks after randomization||||g/dL||Standard Deviation|Mean
1249829|NCT00513617|Primary|Nitric Oxide|Nitric oxide from plasma amino acids|12 weeks after randomization|All subjects that were randomized and dosed - ITT No imputation used.|||uM||Standard Deviation|Mean
1249830|NCT00513617|Secondary|Soluble Vascular Cell Adhesion Molecule|Soluble vascular cell adhesion molecule (sVCAM) a vascular adhesion molecule|12 weeks after randomization|||||||
1249831|NCT00513617|Primary|Gardos Channel Activity|Gardos channel activity: a calcium (Ca2+)–activated K+ channel|12 weeks after randomization|All subjects that were randomized and dosed - Intent to Treat (ITT) No imputation used.|||mmol/10^13 cells x min||Standard Deviation|Mean
1249832|NCT00513604|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|5 years||||Participants|||Number
1249833|NCT00513604|Primary|Clinical Response|Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012||||Participants|||Number
1249834|NCT00513526|Secondary|Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series||Weeks 0, 28 and 76|Samples for this outcome measure were not analyzed due to loss of funding for the central lab.||||||
1249835|NCT00513526|Secondary|HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine|||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1249836|NCT00513526|Secondary|HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine|||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1249837|NCT00513526|Secondary|HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine|||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1249838|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.|||proportion of participants||95% Confidence Interval|Number
1249839|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.|||proportion of participants||95% Confidence Interval|Number
1249840|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.|||proportion of participants||95% Confidence Interval|Number
1249841|NCT00513526|Secondary|HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine|||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1249842|NCT00513526|Secondary|Longitudinal Changes in Plasma HIV-1 RNA From Baseline|Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.|Week 0, 4, 12, 28|Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.|||copies/ml||Inter-Quartile Range|Median
1249848|NCT00513500|Primary|Number of Children Who Received Early and Appropriate Treatment for Pneumonia.|Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom|one year|The number of participants determined for this analysis was based on those classified as pneumonia. The analysis was based on an intent-to-treat basis.|||partcipants|||Number
1249849|NCT00513474|Secondary|Graft-versus-host and Host-versus-graft Immune Responses|Laboratory tests such as limited dilution assay (LDA) were to be performed to assess graft-versus-host and host-versus-graft immune responses.|Days -2, 0, and Days 14, 21 and 35 days post-transplant|Due to laboratory and budgetary issues the planned laboratory testing and assays were not performed and no data were collected.||||||
1249850|NCT00513474|Secondary|Number of Participant With Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.|Up to 71 months|Safety population included all participants who received at least one dose of protocol specified treatment and were in remission at the time of transplant.|||Participants|||Count of Participants
1249851|NCT00513474|Secondary|Uric Acid Levels|Blood was collected and analyzed at a laboratory for serum uric acid levels reported in milligrams(mg)/deciliter(dL). Data is presented for those participants who experienced Grade II to IV aGVHD and those participants who did not experience Grade II to IV aGVHD at pre-transplant and post-transplant.|Pre-transplant Day -7 to Day -1 and Post-transplant Day 0 to Day 6|Intent-to-treat population with data available for analyses.|||mg/dL||Standard Deviation|Mean
1249852|NCT00513474|Primary|Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD)|"aGVHD severity was determined using International Bone Marrow Transplant Registry (IBMTR) scale stage and grade of the skin, liver and gut. Stage 1: Skin=maculopapular rash <25% of body surface; Liver=Bilirubin 2-3 mg/dL and Gut=500-999 mL diarrhea/day or peristent nausea with histologic evidence of GvHD. Stage 2: Skin=maculopapular rash 25-50% of body surface; Liver=Bilirubin 3.1-6 mg/dL and Gut=1000-1499 mL diarrhea/day. Stage 3: Skin=maculopapular rash >50% of body surface; Liver=Bilirubin 6.1-15 mg/dL and Gut=≥1500 mL diarrhea/day. Stage 4: Skin=generalized erythroderma with bulla formation; Liver=Bilirubin >15 mg/dL and Gut=severe abdominal pain.~Grade 1: Stage 1-2 rash; no liver or gut involvement. Grade II: Stage 3 rash, or stage 1 liver involvement, or stage 1 gut involvement. Grade III: None to stage 3 skin rash with stage 2-3 liver, or stage 2-4 gut involvement. Grade IV: Stage 4 skin rash, or stage 4 liver involvement."|Up to 71 months|Intent-to-treat participants included in the analyses.|||percentage of participants|||Number
1249853|NCT00513461|Secondary|Changes in Quality of Life - Mental Score|Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score).|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||scores on a scale||Standard Deviation|Mean
1249854|NCT00513461|Secondary|Changes in Quality of Life - Physical Score|Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score).|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||units on a scale||Standard Deviation|Mean
1249855|NCT00513461|Secondary|HCV RNA|Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems).|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||IU/mL||Standard Deviation|Mean
1249856|NCT00513461|Secondary|Change in Markers of Liver Disease - ALT|ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||IU/L||Standard Deviation|Mean
1249857|NCT00513461|Secondary|Change in Markers of Liver Disease - AST|AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||IU/L||Standard Deviation|Mean
1249858|NCT00513461|Secondary|Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)|Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µg/mL||Standard Deviation|Mean
1249859|NCT00513461|Secondary|Change in SAMe Metabolites - Malondialdehyde (MDA)|malondialdehyde|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µmol/L||Standard Deviation|Mean
1249860|NCT00513461|Secondary|Change in SAMe Metabolites - Plasma GSH|Plasma GSH will be measured using HPLC with fluorescence detection.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µmol/L||Standard Deviation|Mean
1249861|NCT00513461|Secondary|Change in SAMe Metabolites - Total Homocysteine (tHcy)|Total homocysteine (tHcy)|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µmol/L||Standard Deviation|Mean
1249862|NCT00513461|Secondary|Change in SAMe Metabolites - Methionine|Methionine will be measured using HPLC with fluorescence detection.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µmol/L||Standard Deviation|Mean
1249863|NCT00513461|Secondary|Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)|S-adenosylhomocysteine (SAH)|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||nmol/L||Standard Deviation|Mean
1249864|NCT00513461|Secondary|SAMe|Change in SAMe levels|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||nmol/L||Standard Deviation|Mean
1249865|NCT00513461|Secondary|Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma|AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||percentage of AFP-L3/AFP||Standard Deviation|Mean
1249866|NCT00513461|Secondary|Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma|To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||ng/mL||Standard Deviation|Mean
1249867|NCT00513461|Primary|Change in Serum AFP Levels|Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data anlysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||ng/mL||Standard Deviation|Mean
1249868|NCT00513435|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival.|Up to 12 weeks||||Days||Full Range|Median
1249869|NCT00513435|Primary|Overall Response Rate|Response was determined as inicated in the protocol.|From the start of treatment for up to 12 weeks||||participants|||Number
1249870|NCT00513409|Secondary|Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value|Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results.|||subjects|||Number
1249871|NCT00513409|Secondary|Anti-hepatitis A Virus Antibodies Concentration|Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results|||mIU/mL||95% Confidence Interval|Geometric Mean
1249872|NCT00513409|Secondary|Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value|Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results|||subjects|||Number
1249873|NCT00513409|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value|"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F."|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results|||subjects|||Number
1249874|NCT00513409|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F."|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1249875|NCT00513409|Secondary|Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)||||subjects|||Number
1249893|NCT00513370|Secondary|Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA)|Number of subjects with improvement on the Physician's Global Assessment for Psoriasis (PGA). The PGA is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject, where 0 = clear and 6 = very severe. Improvement is defined as a reduction in PGA score.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
1249876|NCT00513409|Secondary|Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)||||subjects|||Number
1249877|NCT00513409|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after the administration of any study vaccine dose||||subjects|||Number
1249878|NCT00513409|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.~Fever was defined as rectal temperature ≥ 38 degrees Celsius."|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.|||subjects|||Number
1249879|NCT00513409|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.|||subjects|||Number
1249880|NCT00513409|Primary|Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)|Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.|||subjects|||Number
1249881|NCT00513370|Secondary|Change in Resource Utilization Outcomes and Costs From Baseline as Measured by the Health Care Resource (HCR) Questionnaire||16 and 24 weeks|||||||
1249882|NCT00513370|Secondary|Change in Productivity Outcomes and Costs From Baseline as Measured by the Health and Labour Questionnaire (HLQ)||16 and 24 weeks|||||||
1249883|NCT00513370|Secondary|Change From Baseline on the EuroQol (EQ-5D) Quality of Life Questionnaire||16 and 24 weeks|||||||
1249884|NCT00513370|Secondary|Mean Change From Baseline in Beck Depression Inventory (BDI-II) at 16 and 24 Weeks|Change in the Beck Depression Inventory from Baseline. The BDI-II contains 21 questions and is scored from 0-63; higher scores indicate more severe depression symptoms.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||units on a scale||Standard Deviation|Mean
1249885|NCT00513370|Secondary|Number of Subjects Achieving a Dermatology Life Quality Index (DLQI) = 0|Number of subjects achieving a Dermatology Life Quality Index (DLQI) score of 0 (indicating total lack of impairment). The DLQI consists of 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
1249886|NCT00513370|Secondary|Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at 16 and 24 Weeks|Mean change in the Dermatology Life Quality Index (DLQI) from Baseline. The questionnaire contains 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired; the minimum clinically important difference is 2.3 to 5.7 point change.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||units on a scale||Standard Deviation|Mean
1249887|NCT00513370|Secondary|Mean Change From Baseline in Patient's Global Assessment of Joint Pain at 16 and 24 Weeks|Mean change in the Patient's Global Assessment of Joint Pain from Baseline, as assessed on a 100-mm visual analog scale where 0 mm = no pain and 100 mm = pain as bad as it could be.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||units on a scale||Standard Deviation|Mean
1249888|NCT00513370|Secondary|Mean Change From Baseline in Swollen Joint Count at 16 and 24 Weeks|Mean change in the number of swollen joints from Baseline. 76 joints were evaluated for swelling, corresponding to all joints evaluated for tenderness except for the hip joints.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||number of joints||Standard Deviation|Mean
1249889|NCT00513370|Secondary|Mean Change From Baseline in Tender Joint Count at 16 and 24 Weeks|Mean change in the number of tender joints from Baseline. 78 joints were evaluated for tenderness, including all 76 joints evaluated for swelling plus the hip joints.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||number of joints||Standard Deviation|Mean
1249890|NCT00513370|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response|PASI 50/75/90/100 is a >=50% / >=75% / >=90% / 100% improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
1249891|NCT00513370|Secondary|Mean Change From Baseline in Physician Global Assessment of Arthritic Disease Activity at 16 and 24 Weeks|Mean Change from Baseline in Physician Global Assessment of Arthritic Disease Activity as measured on a 100-mm visual analog scale where 0 mm = no arthritis activity and 100 mm = extremely active arthritis.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||units on a scale||Standard Deviation|Mean
1249892|NCT00513370|Secondary|"Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of Clear or “Clear or Minimal”"|"Number of subjects achieving a response of Clear or Clear or Minimal on the Physician's Global Assessment for Psoriasis. This is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Minimal, 2-Mild, 3-Moderate, 4-severe, 5-very severe."|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
1249906|NCT00513292|Secondary|Overall Survival (OS)|OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. The difference will be tested using the log-rank test, stratified by tumor size (2.0 - 4.0 cm, > 4.0 cm), age (< 50, >= 50), and hormone receptor status (ER- and PgR-negative, ER- and/or PgR-positive).|From time to registration to death, assessed up to 5 years||2017-06-30|06/2017||||
1249894|NCT00513370|Secondary|Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks|Mean percent change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||percent change||Standard Deviation|Mean
1249895|NCT00513370|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks|Mean change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||unit on a scale||Standard Deviation|Mean
1249896|NCT00513370|Primary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks|PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree|16 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
1249897|NCT00513357|Primary|Change in Appetite as Measured by ESAS|Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation [± 3 days] to 4 week evaluation [± 3 days], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.|Baseline and at 4 weeks||||units on a scale||Standard Deviation|Mean
1249898|NCT00513344|Secondary|Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake|"Value of arterial stiffness at 2 hours minus value at baseline. Arterial stiffness is also automatically calculated by peripheral arterial tonometry which consists in measuring the peripheral vessel endothelial response to an ischemia provoked by a 5-min occlusion of the humeral artery using an armcuff.~An increase in arterial stiffness means an increase in the resistance of the vessel wall which reflects an impaired endothelial response to ischemia."|baseline and 2 hours||||percentage of baseline||Standard Deviation|Mean
1249899|NCT00513344|Primary|Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake|Value of RHI at 2 hours minus value at baseline. RHI reflects the endothelial function of a vessel at the distal phalanx of a finger, i.e. the capacity of the vessel to dilate after an ischemia. RHI is the increase of blood flow following the occlusion of the brachial artery during 5 minutes by the inflation of an armcuff. RHI was measured by peripheral arterial tonometry using a fingerprobe connected to an EndoPat analyser.|Baseline and 2 hours|"Taking into account the fact that there is no background data and that we need to have accurate evaluation of central tendency and dispersion, a minimum of five complete subjects are needed.~Data from all randomized subjects were considered in the intention to treat model (for the primary outcome)."|||percentage of the pulse wave amplitude||Standard Error|Mean
1249900|NCT00513305|Secondary|Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate|The duration of overall survival was defined for all patients and was measured from the date of randomization until death from any cause. For a patient who was not known to have died by the end of the follow-up period, observation of overall survival was censored on the date the patient was last known to be alive. The estimate of likelihood of survival at 6 and 12 months after Baseline using the Kaplan Meier Estimate is presented here.|Baseline through 12 months||||Proportion of Participants||95% Confidence Interval|Number
1249901|NCT00513305|Secondary|Number of Participants Who Experienced Induction (Thirty-Day) Mortality|The number of subjects who died from any cause within the first 30 days after the start of study drug treatment is presented here.|Up to 30 days following start of study drug treatment||||Participants|||Number
1249902|NCT00513305|Secondary|Number of Participants Who Experienced Early Death|Early death is defined as death from any cause within the first 14 days after start of study drug treatment. The number of patients in each study group who experienced early death is presented here.|14 days from start of study drug treatment||||Participants|||Number
1249903|NCT00513305|Secondary|Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate|RFS is defined for patients who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR), and was measured from the date of attaining CR, CRp, or PR until the date of AML relapse or death from any cause, whichever occurred first. For a patient not known to have relapsed or died by the end of the study followup, observation of relapse free survival was censored on the date of the last followup examination. The Kaplan Meier Estimate of relapse-free survival at Month 3 and Month 6 is presented here.|From Baseline (randomization) through 24 months following Baseline|Population analyzed are the subjects who who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR)during the course of the study|||Proportion of participants||95% Confidence Interval|Number
1249904|NCT00513305|Secondary|Number of Participants Who Died or Were Censored by 24 Months|This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.)|From Baseline through 24 months following Baseline||||Participants|||Number
1249905|NCT00513305|Primary|Percentage of Participants in Complete Remission (CR)|The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.|From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator|Intention to treat (ITT) Analysis Set|||Percentage of participants in CR|||Number
1249907|NCT00513292|Secondary|Disease-free Survival (DFS)|DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. The difference will be tested using the log-rank test, stratified by tumor size (2.0 - 4.0 cm, > 4.0 cm), age (< 50, >= 50), and hormone receptor status (ER- and PgR-negative, ER- and/or PgR-positive).|From time to registration to time of event, assessed up to 5 years||2017-06-30|06/2017||||
1249908|NCT00513292|Secondary|Breast Conservation Rates|Method of definitive surgery, categorized as breast conserving surgery (“lumpectomy”) or total mastectomy. Breast conservation rates will be compared using the Mantel-Haenszel test, stratified by tumor size (2.0 -4.0 cm, > 4.0 cm), age (< 50, >= 50) and hormone receptor status (ER- and PgR-negative, ER- and/or PgR positive). The Chi-squared will be conducted at the two-sided .05 level. A 95% confidence interval will be computed for the difference in breast conservation rates.|From time surgery to up to 5 years||2017-06-30|06/2017||||
1249909|NCT00513292|Secondary|Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week|Difference from pretreatment LVEF (%) at 24 weeks [median change from baseline Inter Quartile Range (IQR)].|Baseline, at 24 week|All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.|||percent||Inter-Quartile Range|Median
1249910|NCT00513292|Secondary|LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week|All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks [median change from baseline Inter Quartile Range (IQR)].|At 12 week||||percent||Inter-Quartile Range|Median
1249911|NCT00513292|Secondary|Asymptomatic Decreases From Baseline in LVEF at Week 24|The summary of asymptomatic changed in LVEF.|Baseline, at 24 week|All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.|||Percentage of Participants|||Number
1249912|NCT00513292|Secondary|Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12|The summary of asymptomatic decrease in LVEF.|Baseline, at 12 week|All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12.|||Percentage of participants|||Number
1249913|NCT00513292|Secondary|Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy|pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease).|Up to 5 years|All patients who had clinical N1-3 disease prior to the start of treatment are included in the analysis of the pCR rate in the breast and axillary lymph nodes.|||Percentage (95% confidence Interval)||95% Confidence Interval|Number
1249914|NCT00513292|Primary|pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy|Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.|Up to 5 years|All patients who started study treatment are included in the analysis of the primary endpoint.|||percentage of participants||95% Confidence Interval|Number
1249915|NCT00513240|Secondary|Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose.||24 hours after first EPO dose.|||||||
1249916|NCT00513240|Secondary|EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures).||72 hours postoperatively.|||||||
1249917|NCT00513240|Primary|Scores on Bayley Scales of Infant Development III at Age 1 Years.|3 domains of the Bayley Scales of Infant Development III: Cognitive, Language and Motor Minimum score = 45, maximum score = 155; Population mean = 100, SD = 15; Higher scores are indicative of better outcomes Language scores are reflective of receptive communication and expressive communication subscales. Motor scores are reflective of fine motor and gross motor subscales.|1 year postoperatively||||units on a scale||Standard Deviation|Mean
1249918|NCT00513240|Primary|MRI Severity of Injury Score|MRI severity of injury score change from preoperative brain MRI to 7 day postoperative MRI(decrease by 25%). Scoring of infarction, hemorrhage, white matter injury, cerebral venous sinus thrombosis, or increased lactate on MR spectroscopy.|7 days postoperatively.|||||||
1249919|NCT00513071|Secondary|N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers||At baseline, at 6 hours, at each course (day 1), and at 2 years|Bone marker data was not collected.||||||
1249920|NCT00513071|Secondary|Relationship Between Changes in Laboratory Correlates and Response and Survival||Up to 2 years|Laboratory correlates were not collected.||||||
1249921|NCT00513071|Secondary|Toxicity Data|Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All grade 3 or worse toxicities (Possibly, Probably, or Definitely) attributed to AZD0530.|Up to 2 years|One patient died unexpectedly at home. No autopsy was performed. Treatment was listed as possible cause along with diabetes mellitus, morbid obesity, hypertension, hypercholesterolemia, and renal failure.|||participants|||Number
1249922|NCT00513071|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From start of treatment, up to 5 years||||Months||95% Confidence Interval|Median
1249923|NCT00513071|Secondary|Time to Treatment Failure|Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From first day of treatment until discontinuation of treatment, up to 2 years||||Months||95% Confidence Interval|Median
1249955|NCT00512278|Secondary|A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.|A comparison of the proportion of the subject population with non-detectable HCV-RNA after 24 wks of therapy.|24 weeks||||Participants|||Count of Participants
1249924|NCT00513071|Secondary|Progression-free Survival (PFS)|PFS defined as time between start of treatment and disease progression or death. Using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment until progression or death, up to 2 years||||Months||95% Confidence Interval|Median
1249925|NCT00513071|Primary|PSA Response Rate|Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR|PSA measured every 4 weeks||||percentage of participants|||Number
1249926|NCT00513019|Primary|The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure|The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).|beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point.||||units on a scale||Standard Deviation|Mean
1249927|NCT00512902|Secondary|Change in Modified Rodnan Skin Score (MRSS)|No measures of dispersion was available as data were lost. The range of this measure is 0 to 51 and measures the extent of skin thickening with higher numbers representing thickening.|Baseline vs. Endpoint||||units on a scale||Standard Deviation|Mean
1249928|NCT00512902|Secondary|Change in DLco|DLCO (diffusing capacity or transfer factor of the lung for carbon monoxide (CO)) is the extent to which oxygen passes from the air sacs of the lungs into the blood. Commonly, it refers to the test used to determine this parameter.|Baseline vs. Endpoint (1 year)||||Percent predicted||Standard Deviation|Mean
1249929|NCT00512902|Secondary|Change in TLC (Total Lung Capacity)|No measures of dispersion was available for TLC as data were lost. This describes the total lung capacity as a percent of predicted.|Baseline vs. Endpoint (1 year)||||Percent predicted||Standard Deviation|Mean
1249930|NCT00512902|Secondary|Change in FVC (Forced Vital Capacity)|Measures the amount of air breathed out as a percent of predicted.|Baseline vs. Endpoint (1 year)||||Percent predicted||Standard Deviation|Mean
1249931|NCT00512902|Primary|Treatment-related Adverse Events|Treatment-related adverse events requiring discontinuation.|Baseline vs. Endpoint (1 year)||||participants|||Number
1249932|NCT00512876|Secondary|Size and Extent of Corneal Neovascularization|computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline.|24 weeks||||percentage change||Standard Deviation|Mean
1249933|NCT00512876|Primary|Adverse Events (Ocular and Systemic)||24 weeks||||participants|||Number
1249934|NCT00512798|Primary|Number of Patients With Clinical Anti-tumor Activity Phase II)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Patients with CR + PR + SD|every 9 weeks to a maximum of 54 weeks|Patients who were available to measure response to the study drugs.|||participants|||Number
1249935|NCT00512798|Secondary|Patients With Inhibition of NF-kB (Phase II)|Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells|at baseline, on day 8 and on day 29|Patients with advanced, incurable melanoma who are chemotherapy-naive and patients who had undergone prior chemotherapy with either Dacarbazine or Temozolomide with treatment failure. No degree of inhibition of NF-kB was observed. Phase II not completed due to lack of efficacy.|||participants|||Number
1249936|NCT00512798|Secondary|Patients With Clinical Anti-tumor Activity (Phase I)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|every 9 weeks up to a maximum of 54 weeks|Patients who received treatment and who were available for measurement of lesions.|||participants|||Number
1249937|NCT00512798|Secondary|Patients With Inhibition in NF-kB Activation (Phase I)|Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells|at baseline, on day 8 and on day 29|Phase I patients for whom blood was taken at baseline,on day 8 and on day 29 of each cycle. There was no correlation of change in NF-kB activation with changes in tumor tissue|||participants|||Number
1249938|NCT00512798|Primary|Optimal Doses of Temozolomide and Bortezomib (Phase I)|The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide|up to 42 days|All Phase I patients who received the study drugs|||mg/m2|||Number
1249939|NCT00512707|Other Pre-specified|Change From Baseline in Sex Hormone Binding Globulin (SHBG)||Week 0, Week 14|All available data expressed as absolute value at the given time-point.|||nmol/L||Standard Deviation|Mean
1249940|NCT00512707|Other Pre-specified|Change From Baseline in Free Testosterone|Free testosterone levels were calculated from total testosterone at screening and equilibrium dialysis at randomization and at trial end.|Week 0, Week 14|All available data expressed as absolute value at the given time-point.|||pg/mL||Standard Deviation|Mean
1249941|NCT00512707|Other Pre-specified|Change From Baseline in Total Testosterone|Total testosterone levels were measured between 7:30 and 10:10 a.m. using a liquid chromatography-tandem mass spectrometry assay certified by the Centers for Disease Control and Prevention's Hormone Standardization Program.|Week 0, Week 14|All available data expressed as absolute value at the given time-point.|||ng/dL||Standard Deviation|Mean
1249942|NCT00512707|Secondary|Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)|The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Positive Affects Ratio (PAR), ranging from 0 to 1, is the proportion of total scores (sum of all 8 domains) that is positive (sum of 4 positive domains). Higher PAR represents better affectivity.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||ratios||Standard Deviation|Mean
1249943|NCT00512707|Secondary|Change From Baseline in Derogatis Affects Balance Scale (DABS)|The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Each domain was calculated as the sum of 5-items and could range from 0 to 20, wherein higher scores indicate greater affectivity.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
1249944|NCT00512707|Secondary|Change From Baseline in Psychological General Well-Being Index Score (PGWBI)|Well-being and mood were assessed using the Psychological General Well-Being Index (PGWBI), a 22-item questionnaire that evaluated six dimensions of self-reported wellness: Anxiety (5 questions), Depressed Mood (3 questions), Positive Well-Being (4 questions), Self Control (3 questions), General Health (3 questions), and Vitality (4 questions). Higher scores in each dimension reflect increasing well-being. A global score (ranging from 0 (poor QoL) to 110 (good QoL)) was calculated as the sum of each domain score. The global score and those of its 6 dimensions were normalized to a 100% scale to facilitate comparison.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
1249945|NCT00512707|Secondary|Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)|CAncer Rehabilitation Evaluation System-short form (CARES-SF) marital interaction scale consists of 6 items (range from 0 (best) to 4) and mean of these 6 questions was used to determine intimacy and partner interaction. Lower CARES-SF scores correspond with improved marital interaction.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
1249946|NCT00512707|Secondary|Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)|The Quality of Life for men with Erection Difficulties (QOL-MED) is a cross-cultural instrument to measure quality of life specific to male erection difficulties. The 18 items for this scale were generated from interviews with men with erection difficulties by TH Wagner in 1996. Higher QOL-MED scores reflect better quality of life. Scores were standardized to range of 0 to 100.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
1249947|NCT00512707|Secondary|Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)|MSHQ, a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). A composite score is the sum of Ejaculation and Satisfaction domains, ranging from 7 to 65 (best), with higher score representing better sexual function and satisfaction.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
1249948|NCT00512707|Secondary|Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)|Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Higher percentage of Ejaculations or Satisfaction in successful sexual intercourse represents better sexual function.|Week 0, week 8, week 14|All available data expressed as absolute value at the given time-point.|||percentage of sexual intercourses||Standard Deviation|Mean
1249949|NCT00512707|Secondary|Change From Baseline in Sexual Encounter Profile (SEP)|Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Minimum value is 0 with no maximum limit, wherein higher values representing better sexual encounter.|Week 0, week 8, week 14|All available data expressed as absolute value at the given time-point.|||events/week||Standard Deviation|Mean
1249950|NCT00512707|Secondary|Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.|Week 0, week 8, week 11, week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
1249951|NCT00512707|Primary|Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with Erectile Function domain range of 1 to 30 with higher scores representing better function.|Week 0, week 8, week 11, week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
1249952|NCT00512278|Secondary|Percentage of Participants Experiencing Medically Significant Infections|Medically significant infection was defined as an infection requiring the use of intravenous antibiotics or hospitalization.|72 weeks from initiation of treatment||||Participants|||Count of Participants
1249953|NCT00512278|Secondary|Percentage of Participants Experiencing Serious Adverse Events|The severity of adverse events was graded according to modified World Health Organization grades as mild, moderate, severe, or life-threatening|72 Weeks from initiation of treatment||||Participants|||Count of Participants
1249954|NCT00512278|Primary|Number of Participants Achieving Sustained Virological Response (SVR)|HCV RNA negativity at 24 weeks after completion of all study medications|24 weeks after completion of all study medications||||Participants|||Count of Participants
1249956|NCT00512278|Primary|A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.|A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms|72 Weeks from initiation of treatment|Included all patients who received at least one dose of treatment in both study arms|||percentage of participants|||Number
1249957|NCT00512252|Secondary|Relapse-free Survival|"This is determined only for patients achieving a complete remission. Defined as the interval from the date of the first documentation of a leukemia free state to date of recurrence or death due to any cause.~Kaplain-Meier estimate was used."|1 year|This excludes the 25 participants who had treatment failure.|||percentage of participants|||Number
1249958|NCT00512252|Secondary|Overall Survival||1 year||||percentage of participants|||Number
1249959|NCT00512252|Secondary|Treatment Failure|Treatment failures includes those patients for whom treatment has failed to achieve a CR or a CRi.|42 days||||participants|||Number
1249960|NCT00512252|Secondary|Time to Progression||Every 6 months|"This outcome was not analyzed instead reason for treatment failure was analyzed as it provided better information on why the treatment did not work."||||||
1249961|NCT00512252|Secondary|Pharmacokinetics of AMD3100 on MEC||Day 1 - Phase 2 only|This was not performed.||||||
1249962|NCT00512252|Secondary|Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)|Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.|Day 0||||percentage of AML blasts||Full Range|Median
1249963|NCT00512252|Secondary|Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)|"Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.~Characterization of the mobilized cells as well as the kinetics of mobilization will be determined by analyzing the surface expression of mobilized cells by flow cytometry at the specified time points in conjunction with their total leukocyte count from the patient's CBC."|Day 0||||cells x 10^3/microliter||Full Range|Median
1249964|NCT00512252|Secondary|Time to Platelet Recovery|Defined as the date of the first dose of AMD3100 to the date that the platelet count is >100,000/mm3 in the absence of platelet transfusions.|42 days|This analysis includes patients who achieved a CR.|||days||Full Range|Median
1249965|NCT00512252|Secondary|Time to Neutrophil Recovery|Defined as the date of the first dose of AMD3100 to the date that the absolute neutrophil count >1,000 cells/mm^3.|42 days|This analysis includes patients who achieved a CR or a CRi.|||days||Full Range|Median
1249966|NCT00512252|Secondary|Safety and Tolerability of AMD3100 + MEC.|Treatment related mortality (deaths occurring during treatment)|42 days|The 46 patients include the 6 patients treated on Dose Level 3 of the Phase I portion of the study.|||participants|||Number
1249967|NCT00512252|Primary|Ability of AMD3100 + MEC to Induce dsDNA Damage and Apoptosis in Leukemic Blasts From Bone Marrow or Peripheral Blood Fractions||42 days|This outcome was not analyzed as data was not collected.||||||
1249968|NCT00512252|Primary|Phase II Only: Complete Response Rate of AMD3100 + MEC|"Responses were assessed according to the International Working Group Criteria for AML. All patients who received at least one dose of AMD3100 were considered evaluable for response.~Response rate was the rate of complete remission plus complete remission with incomplete blood count recovery (CR + CRi)."|42 days||||percentage of participants|||Number
1249969|NCT00512252|Primary|Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML|A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 <= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity.|Completion of all patients in Phase I portion (232 days)|The Phase I Dose Escalation portion included (3) patients enrolled in Dose Level 1 and (3) patients enrolled in Dose Level 2. The (6) patients enrolled in Dose Level 3 that determined the Phase II dose are included in the population for this outcome.|||mcg/kg|||Number
1249970|NCT00512148|Secondary|Urodynamic Measurements and Long Term Safety|Safety results are summarized in the Adverse Events section of this listing.|month 12 through month 60|Tengion no longer exists following Chapter 7 bankruptcy in 2014. No data were analyzed.||||||
1249971|NCT00512148|Primary|Overall Safety Profile - Number of Participants Experiencing an Adverse Event|Clinical evaluation of adverse events experienced by patients enrolled in the trial.|through month 12|This analysis was performed on the safety population. Patients undergoing screening and meeting inclusion/exclusion criteria were included in the safety population. Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further data analysis will be made.|||participants|||Number
1249972|NCT00512148|Primary|Change in Maximum Detrusor Pressure From Baseline to 12 Months|Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.|baseline and 12 months|All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis.|||centimeters of water (cm H2O)||95% Confidence Interval|Mean
1249973|NCT00512096|Primary|Number of Participants With Pathologic Complete Remission (pCR)|Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.|restaging with second and fourth 21-day cycles followed by surgery|Participants who completed chemotherapy without progression then had surgical resection.|||participants|||Number
1249974|NCT00511992|Secondary|Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.|CTCAE assessment of toxicity|2 years||||Participants|||Count of Participants
1249975|NCT00511992|Primary|Number of Patients Able to Complete 6 Cycles of Treatment.|Completion of cycle 6|2 years||||Participants|||Count of Participants
1249997|NCT00511875|Primary|Change in Dark Adaptation, Rod Intercept|Change in dark adaptation is measured as dark adaptation time at baseline measured in minutes minus dark adaptation time measured at 24 months|Baseline and 24 months|Of 10 participants who completed doxycycline treatment, usable endpoint data is only available for 8.|||minutes||Standard Deviation|Mean
1249976|NCT00511914|Primary|Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).|"Proportion of subjects with either seroconversion (antibody increase from < 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination).~According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be >40% for adults and >30% for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Percentages of Subjects||95% Confidence Interval|Number
1249977|NCT00511914|Primary|Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).|"HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.~This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70% for adults and >60% for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Percentages of Subjects||95% Confidence Interval|Number
1249978|NCT00511914|Primary|Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Ratio||95% Confidence Interval|Geometric Mean
1249979|NCT00511914|Secondary|Number of Subjects Reporting Local and Systemic Reactions|To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.|3 days postvaccination|Analysis was done on safety set.|||Subjects|||Number
1249980|NCT00511914|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).|Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Titer||95% Confidence Interval|Geometric Mean
1249981|NCT00511901|Secondary|POMS Depression-Dejection Scale|Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed).|3,8,12 weeks|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Scores on a Scale||Inter-Quartile Range|Median
1249982|NCT00511901|Secondary|Activity Counts|Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Counts||Standard Deviation|Mean
1249983|NCT00511901|Secondary|FACIT Measurement System Fatigue Scale|Fatigue score ranges from 0 to 72. Lower score represents less fatigue|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Scores on a Scale||Standard Deviation|Mean
1249984|NCT00511901|Secondary|Short Physical Performance Battery (SPPB) Score|Measure physical function scored 0 - 12 (better)|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Scores on a scale||Standard Deviation|Mean
1249985|NCT00511901|Secondary|Grip Strength|kilograms measured by hand held dynamometer|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||kg||Standard Deviation|Mean
1249986|NCT00511901|Secondary|Length of Stay in Subacute Rehabilitation Facility|Days from randomization to discharge|12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Days||Standard Deviation|Mean
1249987|NCT00511901|Secondary|Motor-FIM Score|FIM Motor score ranges from 13 to 91 (most independent)|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Scores on a Scale||Standard Deviation|Mean
1249988|NCT00511901|Primary|Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study||8 weeks following randomization|Intention to treat; of the subjects not lost to follow-up, 3 subjects in the placebo arm & 2 subjects in the epoetin alpha arm were not available for 8 week hemoglobin draw|||g/dL||Standard Deviation|Mean
1249989|NCT00511875|Secondary|Change in Arteriovenous Ratio Diameter|Change in arteriovenous ratio diameter from baseline|24 months||||ratio||Standard Deviation|Mean
1249990|NCT00511875|Secondary|Change in Central Retinal Vein Equivalent (CRVE) Diameter|Change in Central Retinal Vein Equivalent (CRVE) diameter from baseline|24 months||||μm||Standard Deviation|Mean
1249991|NCT00511875|Secondary|Change in Central Retinal Artery Equivalent (CRAE) Diameter|Change in Central Retinal Artery Equivalent (CRAE) diameter from baseline|24 months||||μm||Standard Deviation|Mean
1249992|NCT00511875|Secondary|Change in Macular Volume|Change in macular volume from baseline|24 months||||mm^3||Standard Deviation|Mean
1249993|NCT00511875|Secondary|Change in Central Subfield Thickness|Change in central subfield thickness from baseline|Baseline and 24 months||||μm||Standard Deviation|Mean
1249994|NCT00511875|Primary|Change in Early Treatment Diabetic Retinopathy Study (ETDRS)|Change in ETDRS visual acuity letter score from baseline. ETDRS is measured on a scale of 0 to 70 where 0 means inability to see anything on the chart and 70 is normal (20/20) acuity.|Baseline and 24 months||||score on a scale||Standard Deviation|Mean
1249995|NCT00511875|Primary|Change in Frequency Doubling Perimetry (FDP)|Change in Frequency Doubling Perimetry (FDP) from baseline, shown as mean and foveal (center of retina) scores|24 months||||dB||Standard Deviation|Mean
1249996|NCT00511875|Primary|Change in Photopic Visual Field|Change in photopic visual fields between baseline and 24 months|Baseline and 24 months||||dB||Standard Deviation|Mean
1249999|NCT00511862|Secondary|Overall Survival|Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.|Time from first TheraSphere treatment to death; median follow up 30 months|In the neuroendocrine group, a median overall survival was not achieved so a post-hoc analysis of 2 year survival was performed in Outcome Measure 3.|||Months||95% Confidence Interval|Median
1250000|NCT00511862|Primary|Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)|Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.|From the date of first treatment until date of first documented progression; median patient follow-up 30 months|Patients receiving at least one TheraSphere treatment with images evaluable by RECIST|||Months||95% Confidence Interval|Median
1250001|NCT00511836|Primary|Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry||14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.|||Percentage (%) of Change||Standard Deviation|Mean
1250002|NCT00511836|Primary|Change From Baseline in BOLD Signal Activation Values for the Inferior Frontal Gyrus||14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.|||Percentage (%) of Change||Standard Deviation|Mean
1250003|NCT00511836|Secondary|Change From Baseline in Daily Craving Score in Alcohol-dependent Subjects (Actiwatch Data)|The Actiwatch-Score device (MiniMitter Co.) was used to collect data on daily alcohol craving. The Actiwatch device is a wrist-worn, battery-operated monitor programmed to beep every 3 hours ±20 minutes, to signal the subjects to enter their alcohol craving or desire to use alcohol at that exact moment on a scale of 0 to 10 units: 0 indicates no craving at all (best score) and 10 indicates extreme craving (worst score). A negative result for Change in Baseline at Day 28 indicates an improvement in daily craving as of 1 month after study drug administration.|28 days (Baseline to Day 28)|All randomized subjects who received at least 1 dose of study drug and had a craving score assessment at Day 28 were included in this analysis. No last-observation-carried-forward (LOCF) approach was used.|||Change in Daily Craving Score||Standard Deviation|Mean
1250004|NCT00511836|Secondary|Change From Baseline in Obsessive-Compulsive Drinking Scale (OCDS) Score in Alcohol-dependent Subjects|There are 14 items on the Obsessive Compulsive Drinking Scale (OCDS). The scale is scored from 0 to 40 (units). A score of 0 units indicates no obsession-compulsion with respect to alcohol (best score). A score of 40 units indicates maximum obsession-compulsion with respect to alcohol (worst score). A negative Change from Baseline value indicates an improvement. For scoring methods, see: Anton RF, Moak DH, Latham P (1995), The Obsessive Compulsive Drinking Scale: A self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcohol Clin Exp Res 19:92-9.|28 days (Baseline to Day 28)|All randomized subjects who received at least 1 dose of study drug and had an Obsessive-Compulsive Drinking Scale (OCDS) assessment at Day 28 were included in this analysis. No last-observation-carried-forward (LOCF) approach was used.|||Change in OCDS score||Standard Deviation|Mean
1250005|NCT00511836|Primary|Change From Baseline in Blood Oxygen-level-dependent (BOLD) Signal Activation Values Detected in the Reward Circuitry of the Brain in Alcohol-dependent Subjects After Presentation of Alcohol-related Cues.|As was standard among fMRI studies conducted at the study site at the time, a change in BOLD signal in the range of 5% to 6% in anterior cingulate as measured using a 3T magnet,is considered highly significant in block-designed experiments.|14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.|||Percentage (%) of Change||Standard Deviation|Mean
1250006|NCT00511810|Primary|Mood Symptoms Ratings|Depression symptom severity was determined with the Children’s Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of <28. (The total score is the sum of the ratings on each of the 17 items.)|10 weeks||||CDRS-R score||Standard Deviation|Mean
1250007|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Patients Without Previous Medication|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|The number of subjects without previous medication in DRSP 1 mg/EE 20 μg group was 1, so the standard deviation was not measurable. The number of subjects without previous medication in the other three groups were 0, so the data were not applicable.|||scores on a scale||Standard Deviation|Mean
1250008|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|FAS|||scores on a scale||Standard Deviation|Mean
1250028|NCT00511797|Secondary|Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250009|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to Cycle 4 (28 days per cycle)|FAS|||scores on a scale||Standard Deviation|Mean
1250010|NCT00511797|Post-Hoc|Change From Baseline for Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.|From baseline to Cycle 4(28 days per cycle)|FAS (Participants with data at Cycle 4)|||scores on a scale||Standard Deviation|Mean
1250011|NCT00511797|Secondary|Change From Baseline in Serum Progesterone Level at Cycle 4|Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||ng/mL||Full Range|Mean
1250012|NCT00511797|Secondary|Change From Baseline in Serum Estradiol Level After 4-cycle Treatment|Estradiol is a predominant sex hormone that presents in female.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||pg/mL||Full Range|Mean
1250013|NCT00511797|Secondary|Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment|CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||mg/dL||Full Range|Mean
1250014|NCT00511797|Secondary|Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||Units/L||Full Range|Mean
1250015|NCT00511797|Secondary|Participants With Non-heavy Withdrawal Bleeding|Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).|At Cycle 4 (28 dyas per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250016|NCT00511797|Secondary|Participants With Non-heavy Intracyclic Bleeding|Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250017|NCT00511797|Secondary|Participants With Intracyclic Bleeding|Intracyclic bleedings were defined as bleedings while a participant takes active drugs.|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250018|NCT00511797|Secondary|Participants With Withdrawal Bleeding|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250019|NCT00511797|Secondary|Number of Bleeding / Spotting Days|Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.|For the first 90 days|FAS (Participants with the defined data)|||days||Standard Deviation|Mean
1250020|NCT00511797|Secondary|Number of Bleeding / Spotting Episodes|Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.|For the first 90 days|FAS (Participants with the defined data)|||number of episodes||Standard Deviation|Mean
1250021|NCT00511797|Secondary|Change From Baseline in Endometrial Thickness After 4-cycle Treatment|Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||mm||Standard Deviation|Mean
1250022|NCT00511797|Secondary|Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||scores on a scale||Standard Deviation|Mean
1250023|NCT00511797|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||scores on a scale||Standard Deviation|Mean
1250024|NCT00511797|Secondary|Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250025|NCT00511797|Secondary|Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250026|NCT00511797|Secondary|Number of Participants With Severity of Headache During Menstruation at Cycle 4|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250027|NCT00511797|Secondary|Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4|Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
1250029|NCT00511797|Secondary|Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.|Baseline and up to 4 Cycles (28 days per cycle)|FAS|||scores on a scale||Standard Deviation|Mean
1250030|NCT00511797|Primary|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|FAS|||scores on a scale||Standard Deviation|Mean
1250031|NCT00511706|Secondary|Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at Screening and Week 25.|Screening (-Week 28), Week 25|Participants from the intent-to-treat population (all randomized participants) with data available at Screening and Week 25 for analyses.|||Millimeters square (MM^2)||Standard Deviation|Mean
1250032|NCT00511706|Secondary|Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.|Baseline, Week 25|Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.|||Microns||Standard Deviation|Mean
1250033|NCT00511706|Secondary|Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 25|Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.|||Letters||Standard Deviation|Mean
1250034|NCT00511706|Primary|Injection Free Interval|The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator’s determination of eligibility to receive a third ranibizumab injection in the study eye.|Week 1 to Week 25|Intent-to-treat population consisted of all randomized patients.|||Days||Inter-Quartile Range|Median
1250035|NCT00511667|Primary|Participants Discontinued Because of Any Clinical Adverse Experience||Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)||||participants|||Number
1250036|NCT00511667|Secondary|Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||nM||Standard Deviation|Mean
1250037|NCT00511667|Secondary|Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||hours||Standard Deviation|Mean
1250038|NCT00511667|Secondary|Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||hours||Full Range|Mean
1250039|NCT00511667|Secondary|Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||nM||Standard Deviation|Mean
1250040|NCT00511667|Secondary|Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||nM-hr||Standard Deviation|Mean
1250041|NCT00511667|Primary|Participants With Any Clinical Adverse Experience||Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)||||percentage of of participants|||Number
1250042|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period|During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.|Outpatient Days 1 to 14|All participants who experienced one or more adverse events during the Outpatient Treatment Period.|||participants|||Number
1250043|NCT00511472|Secondary|24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7|Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.|24 hours|All participants who had 24-hour weighted mean blood glucose levels evaluated on Day 7|||mg/dL||Standard Deviation|Least Squares Mean
1250044|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event - Titration Scheme 2|Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration.|25 days|All participants who experienced one or more adverse events within 25 days of Titration Scheme 2|||participants|||Number
1250045|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event - Titration Scheme 1|In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose [TD] Days 1 to 4 of the Titration Phase 1 of the study.|25 days|All participants who experienced one or more adverse events within 25 days of Titration Scheme 1|||participants|||Number
1250046|NCT00511472|Primary|Number of Participants Who Experienced an Adverse Event During the Study||39 days|All participants who experienced one or more adverse events during the study|||participants|||Number
1250047|NCT00511433|Primary|Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."|||IU/L||Standard Deviation|Mean
1250048|NCT00511433|Secondary|Average Number of Withdrawal Bleeding Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."|||Days||Standard Deviation|Mean
1250049|NCT00511433|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||Days||Standard Deviation|Mean
1250050|NCT00511433|Primary|Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."|||International units per liter (IU/L)||Standard Deviation|Mean
1250051|NCT00511433|Primary|Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."|||picomoles per liter (pmol/L)||Standard Deviation|Mean
1250052|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Maximum Progesterone Value|The maximum progesterone value was defined as the largest value during a cycle.|Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
1250053|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Maximum Follicle Diameter|The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.|Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."|||millimeters (mm)||Standard Deviation|Mean
1250054|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation|During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.|Cycle 1, Cycle 2, and Cycle 6|"Intent-to-treat (ITT) group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."|||Participants|||Number
1250055|NCT00511433|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 5 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.|||Participants|||Number
1250056|NCT00511433|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||Participants|||Number
1250085|NCT00511355|Primary|Serum Concentration of Total Triglycerides|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
1250086|NCT00511355|Primary|Serum Concentration of Lipoprotein(a)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||g/L||Standard Deviation|Mean
1250057|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250058|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250059|NCT00511433|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250060|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250061|NCT00511433|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 woman years) that the women were under risk of becoming pregnant.|6 cycles|"The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or without sexual intercourse per diary card data)."|||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
1250062|NCT00511433|Secondary|Effect on Maximum Endometrial Thickness|Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.|Screening Cycle, Cycle 1, Cycle 2, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle."|||mm||Standard Deviation|Mean
1250063|NCT00511433|Secondary|Effect on Cervical Mucus as Determined by Insler Score|The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.|Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."|||score on a scale||Standard Deviation|Mean
1250064|NCT00511355|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding/spotting was defined as any episode that occurred during the expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants who had withdrawal bleeding/spotting for the respective cycle."|||Days||Standard Deviation|Mean
1250302|NCT00510146|Secondary|Change From Baseline to Endpoint in Hematocrit (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||proportion of blood volume||Standard Deviation|Mean
1250065|NCT00511355|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants who had breakthrough bleeding/spotting for the respective cycle."|||Days||Standard Error|Mean
1250066|NCT00511355|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 5 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.|||Participants|||Number
1250067|NCT00511355|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250068|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250069|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250070|NCT00511355|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250071|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
1250353|NCT00509925|Secondary|Body Weight|Body weight after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kg||Standard Deviation|Mean
1250072|NCT00511355|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of 2 days. Each 13 cycles (28 days per cycle) constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|6 cycles|"The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse per diary card data)."|||Pregnancies per 100 woman years|Woman years (rounded to nearest integer)|95% Confidence Interval|Number
1250073|NCT00511355|Secondary|Serum Concentration of Dihydrotestosterone (DHT)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
1250074|NCT00511355|Secondary|Serum Concentration of Androstenedione|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
1250075|NCT00511355|Primary|Serum Concentration of Thyroxin Binding Globulin (TBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mg/L||Standard Deviation|Mean
1250076|NCT00511355|Primary|Serum Concentration of Free Thyroxine (T4)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||pmol/L||Standard Deviation|Mean
1250077|NCT00511355|Primary|Serum Concentration of Thyroid Stimulating Hormone (TSH)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mU/L||Standard Deviation|Mean
1250078|NCT00511355|Primary|Serum Concentration of Corticosteroid Binding Globulin (CBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline to Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
1250079|NCT00511355|Primary|Serum Concentration of Total Cortisol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
1250080|NCT00511355|Primary|Serum Concentration of Hemoglobin Type A1c (HbA1c)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of glycosylated hemoglobin||Standard Deviation|Mean
1250081|NCT00511355|Primary|Incremental AUC3 for Insulin (OGTT)|Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||hrs*pmol/L||Standard Deviation|Mean
1250082|NCT00511355|Primary|AUC3 for Insulin (OGTT)|Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||hrs*pmol/L||Standard Deviation|Mean
1250083|NCT00511355|Primary|Incremental AUC3 for Glucose (OGTT)|Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||hrs*mmol/L||Standard Deviation|Mean
1250084|NCT00511355|Primary|Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT])|Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||hrs*mmol/L||Standard Deviation|Mean
1250087|NCT00511355|Primary|Serum Concentration of Apolipoprotein B|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||g/L||Standard Deviation|Mean
1250088|NCT00511355|Primary|Serum Concentration of Apolipoprotein A-1|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||g/L||Standard Deviation|Mean
1250089|NCT00511355|Primary|Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
1250090|NCT00511355|Primary|Serum Concentration of HDL3-cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
1250091|NCT00511355|Primary|Serum Concentration of HDL2-cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
1250092|NCT00511355|Primary|Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
1250093|NCT00511355|Primary|Serum Concentration of Total Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
1250094|NCT00511355|Primary|Serum Concentration of C-Reactive Protein (CRP)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mg/L||Standard Deviation|Mean
1250095|NCT00511355|Primary|Serum Concentration of Sex Hormone Binding Globulin (SHBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
1250096|NCT00511355|Primary|APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Ratio||Standard Deviation|Mean
1250097|NCT00511355|Primary|Serum Concentration of Protein C|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
1250098|NCT00511355|Primary|Serum Concentration of Protein S (Total)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
1250099|NCT00511355|Primary|Serum Concentration of Protein S (Free)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
1250100|NCT00511355|Primary|Serum Concentration of Antithrombin III|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
1250101|NCT00511355|Primary|Serum Concentration of Clotting Factor II|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
1250102|NCT00511355|Primary|Serum Concentration of Clotting Factor VIII|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
1250103|NCT00511355|Secondary|Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||umol/L||Standard Deviation|Mean
1250104|NCT00511355|Secondary|Serum Concentration of Free Testosterone|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||pmol/L||Standard Deviation|Mean
1250105|NCT00511355|Secondary|Serum Concentration of Total Testosterone|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
1250106|NCT00511355|Primary|Serum Concentration of Clotting Factor VIIc|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
1250107|NCT00511355|Primary|Serum Concentration of Clotting Factor VIIa|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||U/L||Standard Deviation|Mean
1250108|NCT00511355|Primary|Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Ratio||Standard Deviation|Mean
1250109|NCT00511355|Primary|Serum Concentration of D-Dimer|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mg/L Fibrinogen Equivalent Units (FEU)||Standard Deviation|Mean
1250110|NCT00511355|Primary|Serum Concentration of Prothrombin Fragments 1 + 2|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
1250111|NCT00511342|Secondary|Average Number of Withdrawal Bleeding-spotting Days|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
1250112|NCT00511342|Secondary|Average Number of Breakthrough Bleeding-Spotting Days|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if so, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any bleeding/spotting episode that occurred during the “expected non-bleeding period” that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
1250132|NCT00511238|Primary|Best Overall Response Rate (ORR)|For both A0 and A1, to evaluate the best overall response rate (stringent complete response [sCR]+ complete response [CR]+ very good partial response [VGPR]+ partial response [PR]) in patients with multiple myeloma who had previously received bortezomib and either thalidomide or lenalidomide, had relapsed after two or more therapies, and were refractory to the most recently received therapy|A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.|Analysis population described in reporting groups below|||% of participants w/ PR or better||95% Confidence Interval|Number
1250113|NCT00511342|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the “expected non-bleeding period” of the next cycle. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
1250114|NCT00511342|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
1250115|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the “expected non-bleeding period” that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
1250116|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the “expected non-bleeding period” that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
1250117|NCT00511342|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
1250118|NCT00511342|Primary|Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck|BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, & more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA).|Baseline and after cycle 26 (2 years)|All-Subjects-Treated (AST) group consisted of all randomized participants who took at least one dose of trial medication. The number of participants in the AST group with a baseline value and a Week 26 value is presented.|||score on a scale||Standard Deviation|Mean
1250119|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the “expected non-bleeding period” that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
1250120|NCT00511342|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|"Contraceptive efficacy parameter of this trial was the Pearl Index. In-treatment pregnancies were pregnancies with an estimated date of conception from~the day of first intake of trial medication up to and including the day of last(active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant."|2 years (26 cycles)|Restricted Intent-To-Treat (ITT) analysis set included all participants treated, and further excluded non-pregnant participants without at least one cycle expected to be at risk for pregnancy(with recorded use of condoms or without confirmed sexual intercourse, as determined from the electronic diary data).|||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
1250121|NCT00511329|Secondary|Secondary Outcome Variables Will Include Change in Lean Body Mass, Change in Bone Mineral Content, Change in Inflammatory Mediated Cytokine Levels and Change in Bone Turnover.||12 months|PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.||||||
1250122|NCT00511329|Primary|The Primary Outcome Variables Will be Height and Weight Z Score.||12 months|PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.||||||
1250123|NCT00511238|Secondary|Overall Survival (A1 Only)|The time from start of treatment to death due to any cause OS was to be censored on the date the subject was last known to be alive for those who were alive or lost to follow-up as of a data analysis cutoff date.|Patients were to be followed by telephone contact for disease progression and OS every 3 months after study discontinuation for the first year and every 6 months thereafter for up to 2 years||||months||95% Confidence Interval|Number
1250124|NCT00511238|Secondary|Progression-free Survival (A1 Only)|The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"|||months||95% Confidence Interval|Median
1250125|NCT00511238|Secondary|Progression-free Survival (A0 Only)|The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.|||months||95% Confidence Interval|Median
1250126|NCT00511238|Secondary|Time to Progression (A1 Only)|Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"|||months||95% Confidence Interval|Median
1250127|NCT00511238|Secondary|Time to Progression (A0 Only)|Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.|||months||95% Confidence Interval|Median
1250128|NCT00511238|Secondary|Duration of Response (A1 Only)|Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|Response assessments same as described in primary outcome measure|Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See overall analysis population description of response-evaluable population above.|||months||95% Confidence Interval|Median
1250129|NCT00511238|Secondary|Duration of Response (A0 Only)|Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|Response assessments same as described in primary outcome measure|Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See analysis population description of response-evaluable population above.|||days||95% Confidence Interval|Median
1250130|NCT00511238|Secondary|Clinical Benefit Response (CBR) (A1 Only)|sCR, CR, VGPR, PR, and minimal response (MR)|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"|||participants|||Number
1250131|NCT00511238|Secondary|Clinical Benefit Response (CBR) (A0 Only)|sCR, CR, VGPR, PR, and minimal response (MR)|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.|||participants|||Number
1250166|NCT00510952|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint|Actual measurements and daily mean blood glucose levels at endpoint.|24 weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1250133|NCT00511199|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
1250134|NCT00511199|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
1250135|NCT00511199|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 12 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.|||Participants|||Number
1250136|NCT00511199|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||Participants|||Number
1250137|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of~the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||Participants|||Number
1250138|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||Participants|||Number
1250139|NCT00511199|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
1250140|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
1250141|NCT00511199|Primary|Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).|||Pregnancies per 100 woman years|woman years (rounded to nearest integer)|95% Confidence Interval|Number
1250142|NCT00511199|Primary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).|||Pregnancies per 100 woman years|woman years (rounded to nearest integer)|95% Confidence Interval|Number
1250143|NCT00511173|Primary|In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).|Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).|six months|power analysis based on data from Sconce, et al.|||mg/wk||Standard Deviation|Mean
1250144|NCT00511147|Secondary|Regression of Hemorrhage/Bleedings|Defined by the percentage of treated patients with hemorrhage/bleedings at Day 1 (i.e., the day of the first infusion, pre-infusion) who improve their diathesis during the clinical follow-up period ending on Day 15 ± 1.|15 days|Number of participants analyzed is based on the number of patients with hemorrhage/bleeding at Day 1 in the Modified ITT Population|||percent of subjects with regression|||Number
1250145|NCT00511147|Secondary|Duration of Response|Defined by the number of consecutive days for which the platelet count remains ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1.|30 days|Number of participants analyzed is based on the number of responding patients (52/64 [81.3%]) in the Modified ITT Population|||days||Standard Deviation|Mean
1250146|NCT00511147|Secondary|Time to Platelet Count Recovery|Defined by the number of days elapsed from Day 1 (the day of the first infusion of the IP) to the day when the platelet count is first known to be ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1|30 days|Number of participants analyzed is based on the number of responding patients (52/64 [81.3%]) in the Modified ITT Population|||days||Standard Deviation|Mean
1250147|NCT00511147|Primary|Response Rate|Defined by the percentage of treated patients in whom platelet counts increase from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L by Day 8 ± 1 [where the day of the first infusion is Day 1]|8 days|Modified ITT Population|||percentage of responders|||Number
1250148|NCT00511134|Secondary|Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level|Endpoint abstinence will be defined as 0 cigarettes over the seven days prior to the subject’s Timeline Follow-Back evaluation at the end of week 7 (end of trial) and a Carbon Monoxide (CO) level ≤ 5.|6 weeks after target smoking quite date||||participants|||Number
1250149|NCT00511134|Primary|Level of Insomnia as Measured by the Insomnia Severity Index|Insomnia Severity Index (ISI): 13-item self-report measure which examines symptoms of insomnia, consequences of insomnia, and subjective distress related to sleep problems. Subjects rate the symptoms and consequences of insomnia on a 5 point Likert scales. For example, subjects are asked to rate the severity of their insomnia (e.g., difficulty falling asleep from 0=none to 4=very severe). Scores on the first 7 items are summed for a total insomnia score ranging from 0-28.|6 weeks after target smoking quit date|Baseline descriptive data was examined for the 4 participants. Outcome measures were available for 2 participants. Due to the small number of participants, statistical comparisons were not able to be performed.|||Units on a Scale||Full Range|Median
1250150|NCT00511108|Secondary|Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment|Glucose concentration was measured at 11 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.|||mg*hr/dL||95% Confidence Interval|Least Squares Mean
1250226|NCT00510289|Secondary|Time to Progression|Time to progression will be defined as the number of months between on-study and the date of progression or death, whichever comes first, in subjects who took study drug for at least cycle 1.|5 years|7 patients completed cycle one and had bone marrow biopsies to confirm response.|||months||Full Range|Median
1250151|NCT00511108|Primary|Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment|"Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state.~Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100."|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1250152|NCT00511108|Primary|Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment|Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.|||pg*hr/mL||95% Confidence Interval|Least Squares Mean
1250153|NCT00511095|Secondary|Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28|Measurement of Serum GMC|Weeks 4, 8, 12, and 28|Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.|||mIU/mL||95% Confidence Interval|Geometric Mean
1250154|NCT00511095|Secondary|Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.|Seroprotective Immune Response|Weeks 4, 8, 12 and 28|Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.|||percentage of subjects|||Number
1250155|NCT00511095|Primary|Percentage of Participants With Local and Systemic Post-injection Reaction Rates|Local and Systemic post-injection reactions.|Within 7 days post-injection for post-injection reactions|Safety Population: Subjects who received at least 1 study injection and had any post-baseline safety data|||percentage of subjects|||Number
1250156|NCT00511004|Secondary|Brugia Specific Immunoglobulin G4 (IgG4) Antibodies|IgG4 antibodies directed against Brugia malayi antigen|2 years|By 2 years, 4 subjects in High Dose Group lost to followup|||ng/ml||Full Range|Median
1250157|NCT00511004|Secondary|Microfilarial Levels at 2 Years|Night time microfilarial levels at 2 years|2 years from time enrolled|By 2 years, 4 subjects in High Dose Group lost to followup|||MF/ML||Full Range|Median
1250158|NCT00511004|Secondary|Adult Worm Burdens at 2 Years|Doppler detected worm nests at 2 years|2 years from the time enrolled.|By 2 years, 4 subjects in High Dose Group lost to followup|||Number of nests||Full Range|Median
1250159|NCT00511004|Primary|Microfilarial Counts at 1 Year|Night time microfilarial counts at 1 year|1 year from time enrolled||||MF/ML||Full Range|Median
1250160|NCT00510952|Secondary|Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms).|24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||Units of insulin/kilograms (U/kg)||Standard Deviation|Mean
1250161|NCT00510952|Secondary|Total Daily Insulin Dose (Units) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||Units of insulin||Standard Deviation|Mean
1250162|NCT00510952|Secondary|Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint||Baseline, 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||kilograms (kg)||Standard Deviation|Mean
1250163|NCT00510952|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||hypoglycemic events per 30 days||Standard Deviation|Mean
1250164|NCT00510952|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.|Baseline to 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||hypoglycemic event per 1 year||Standard Deviation|Mean
1250165|NCT00510952|Secondary|Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value <2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline to 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||participants|||Number
1250167|NCT00510952|Secondary|Glycemic Variability at Endpoint|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1250168|NCT00510952|Secondary|Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint|Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||percentage of participants|||Number
1250169|NCT00510952|Secondary|Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value||Baseline, 12 Weeks, 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||percent hemoglobin||Standard Error|Least Squares Mean
1250170|NCT00510952|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||percent of HbA1c||Standard Error|Least Squares Mean
1250171|NCT00510887|Secondary|Number of Participants With Neuropathy, Any Grade|Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).|up to 1 year||||participants|||Number
1250172|NCT00510887|Secondary|Number of Participants With a Grade 3-4 Hematologic Toxicity.|Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).|up to 1 year||||participants|||Number
1250173|NCT00510887|Secondary|Percentage of Subjects Experiencing Overall Survival|Overall survival is from the day of enrollment to date of death from any cause.|up to 2 years||||percentage of participants|||Number
1250174|NCT00510887|Secondary|Percentage of Subjects Experiencing Progression Free Survival|Progression free survival is measured from treatment to progression or death, whichever comes first. Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment.|up to 2 years||||percentage of participants|||Number
1250175|NCT00510887|Secondary|Duration of Response|Duration of response is measured from time of treatment to time of disease progression|up to 4 years||||months||Full Range|Mean
1250176|NCT00510887|Primary|Complete and Partial Response|"Complete Response: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms and normalization of biochemical abnormalities (eg. LDH) definitely assignable to follicular lymphoma.~Partial Response requires the following:~greater than or equal to 50% decrease in the SPD of the 6 largest dominant nodes of nodal masses.~No increase in size of other nodes, liver, or spleen.~Splenic and hepatic nodes must regress by at least 50% in sum of the products (SPD).~Bone marrow assessment in irrelevant for determination of Partial Response since it is not measurable disease; however, if positive the type of cell should be reported.~No new lesions."|1 year||||percentage of participants|||Number
1250177|NCT00510874|Secondary|Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.|At Days 0, 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Participants|||Count of Participants
1250178|NCT00510874|Secondary|Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.|At Days 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
1250179|NCT00510874|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.|At Days 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Participants|||Count of Participants
1250180|NCT00510874|Secondary|Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 21 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
1250181|NCT00510874|Primary|Number of Subjects With Any Serious Adverse Events (SAEs).|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
1250182|NCT00510874|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Between Day 0 and Day 84 after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
1250183|NCT00510874|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 21-day follow-up period (Days 0-20) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
1250184|NCT00510874|Primary|Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).|A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
1250185|NCT00510874|Primary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
1250186|NCT00510874|Primary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
1250187|NCT00510874|Primary|Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Participants|||Count of Participants
1250188|NCT00510874|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
1250189|NCT00510874|Primary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Participants|||Count of Participants
1250190|NCT00510835|Secondary|Resource Use and Costs of Alternative Resuscitation Strategies||at discharge or 60 days, whichever comes first|||||||
1250191|NCT00510835|Secondary|Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis.||study hour 0, 6, 24 & 72|||||||
1250192|NCT00510835|Primary|Hospital Mortality|The primary study outcome is hospital mortality (defined as the number of deaths prior to discharge or 60 days, whichever comes first). The secondary outcomes are duration of survival (90 day and 1 year) and clinical evidence of organ dysfunction.|prior to discharge or 60 days, whichever comes first||||Participants|||Count of Participants
1250193|NCT00510809|Secondary|Adverse Events Reported|All events reported that were deemed to be related, or unrelated, to the study drug.|Week 8||||number of events reported|||Number
1250194|NCT00510809|Primary|Lipid Profile||Change between Week 8 and Baseline||||mg/dl||Standard Error|Mean
1250195|NCT00510783|Primary|Number of Participants Who Experienced a Recurrent Seizure After Treatment.|Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.|24 hours||||participants|||Number
1250196|NCT00510744|Primary|Fat Absorption|72 hour fat absorption study|3 months|each patients as their own control, baseline fat absorption vs post 3 month enzyme supplementation fat absorption|||g/d||Standard Error|Mean
1250197|NCT00510692|Secondary|Number of Subjects With Adverse Events.|Incidence of adverse events in each treatment group.|6 months compared to baseline||||participants|||Number
1250198|NCT00510692|Secondary|Relative EPA Concentration of Total Free Fatty Acids in the Rectal Mucosa.|Relative EPA concentration of total free fatty acids in the rectal mucosa of subjects with FAP.|6 months compared to baseline.|3 subjects in the full analysis set had no samples for analysis.|||percentage of total fatty acid content||95% Confidence Interval|Mean
1250199|NCT00510692|Secondary|Change in Global Rectal Polyp Burden.|"Change in global rectal polyp burden in subjects treated with Eicosapentanoic Acid (EPA) compared to subjects receiving placebo. Each reviewer in the Polyp Video Scoring Committee assessed global colorectal polyp burden change as better, same as or worse. The qualitative assessment was assigned a score of +1 for better, 0 for same as and -1 for worse. Thereafter a mean overall reviewers score was calculated."|6 months compared to baseline.|5 subjects in the full analysis set lacked the video required for determining global rectal polyp burden due to failure of equipment.|||units on a scale||95% Confidence Interval|Mean
1250200|NCT00510692|Secondary|Percentage Change in the Number of Polyps Measured in the Defined Focal Area of the Rectum.|Percentage change in the number of polyps measured in the defined focal area of the rectum in subjects treated with EPA compared to subjects receiving placebo.|6 months compared to baseline.|13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.|||percentage of change in total polyps||95% Confidence Interval|Mean
1250201|NCT00510692|Primary|Absolute Change in the Number of Polyps Measured in a Focal Area of the Rectum.|Absolute change in the number of polyps measured in a defined focal area of the rectum.|6 months compared to baseline.|13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.|||Change from baseline number of polyps.||Standard Deviation|Mean
1250202|NCT00510653|Primary|Overall Response Rate (ORR)|ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): >/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or > increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.|6 weeks with re-evaluation every 6 weeks or until disease progression|Two participants were not evaluable for response: in 1 participant, early toxicity caused discontinuation of the drug, and the other patient had an intestinal obstruction requiring palliative surgery after 1 day of therapy.|||participants|||Number
1250203|NCT00510510|Secondary|Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day|Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 & 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.|28 Days||||Liters||Standard Error|Least Squares Mean
1250204|NCT00510510|Primary|Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)|The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.|28 days||||Participants|||Number
1250205|NCT00510497|Secondary|Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)|Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption|at the end of 12 weeks treatment interruption||||log10 HIV RNA||Full Range|Median
1250206|NCT00510497|Primary|Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.|AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004|80 weeks||||participants with Grade 3 events related|||Number
1250207|NCT00510484|Secondary|Percentage of Days With no Abdominal Pain.|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
1250208|NCT00510484|Secondary|Percentage of Days With no Flatulence.|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
1250209|NCT00510484|Other Pre-specified|Percentage of Days With Formed/Normal Stools.|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
1250210|NCT00510484|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Number per day||Standard Deviation|Mean
1250211|NCT00510484|Secondary|Total Stool Weight (Grams)|Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Grams||Standard Deviation|Mean
1250212|NCT00510484|Secondary|Total Fat Excretion (Grams)|Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Grams||Standard Deviation|Mean
1250213|NCT00510484|Secondary|Coefficient of Nitrogen Absorption (%)|This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage||Standard Deviation|Mean
1250214|NCT00510484|Primary|Coefficient of Fat Absorption (%)|This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage||Standard Deviation|Mean
1250215|NCT00510458|Secondary|Percentage of Cases That Did Not Have Any Component Revised|"A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner.~The 97.42% estimate is obtained by Kaplan-Meier method."|5 years|Participants/hips with available data.|||percentage of hips|hips||Number
1250216|NCT00510458|Secondary|Number of Hips Evaluated as Radiographically Unstable|"Radiographic instability is defined as having any of the following findings on x-ray:~Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component~Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component~Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component~Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm."|1, 3, 5 years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 1 year population.|||hips|hips||Count of Units
1250217|NCT00510458|Secondary|Number of Hips That Dislocated|The number of hips that experienced a hip dislocation.|3 and 5 years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 3 year population.|||hips|hips||Count of Units
1250218|NCT00510458|Secondary|Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative|The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|preoperative, 1, 3, and 5 Years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
1250219|NCT00510458|Secondary|Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.|The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|preop, 1, 3, and 5 Years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
1250220|NCT00510458|Secondary|Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.|"This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome.~Flexion:~0-45 degrees x 1.0 index value = max 45 points~45-90 degrees x 0.6 index = max 27 points~90-110 degrees x 0.3 index = max 6 points~110-130 degrees = max 0 points~Abduction:~0-15 degrees x 0.8 index = max 12 points~15-20 degrees x 0.3 index = max 1.5 points~20-45 degrees x 0 index = max 0 points~External Rotation in extension:~0-15 degrees x 0.4 index = max 6 points~Over 15 degrees = max 0 points~Internal Rotation in extension:~Any = max 0 points~Adduction:~0-15 degrees x 0.2 index = max 3 points~Over 15 degrees – max 0 points~To determine the over-all rating for range of motion, multiply the sum of the index values x 0.05."|preoperative, 1, 3, and 5 Years|"Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.~Cases at 1 and 5 years all had a score of 5, therefore there is zero standard deviation."|||units on a scale|hip|Standard Deviation|Mean
1250221|NCT00510458|Secondary|Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits|"This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it.~Pain:~None or ignores it = 44 points~Slight, occasional, no compromise in activities = 40 points~Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points~Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points~Marked pain, serious limitation of activities = 10 points~Totally disabled, crippled, pain in bed, bedridden = 0 points"|preop, 1, 3, and 5 Years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
1250222|NCT00510458|Secondary|Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits|"The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The HHS assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor.~90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor"|preoperative, 1, 3, and 5 years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
1250223|NCT00510458|Primary|Linear Wear Rate|Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period.|5 Years Post-Surgery|Participants/hips with available data.|||mm/year|hips|Standard Deviation|Mean
1250224|NCT00510289|Secondary|Change in Microvessel Density|Microvessel density will be measured before and after treatment, and the distribution of change across time will be summarized with descriptive statistics.|Measured before and after treatment|This outcome was not analysed due to the early closure of the study.||||||
1250225|NCT00510289|Secondary|Overall Survival|Overall Survival is defined as the number of months from enrollment onto the study until death from any cause in subjects who took study drug for at least cycle 1.|1 year from the last dose of study drug|7 subjects completed cycle 1 or beyond.|||months||Full Range|Mean
1250227|NCT00510289|Secondary|Number of Subjects Requiring Dose Reductions|The number of subjects who took study drug for more than 1 cycle and required a dose reduction down to the next dose level.|While on study drug, a maximum of 5 years|7 Subjects completed beyond cycle 1. 4 of those subjects had dose reductions during the time they took study drug.|||participants|||Number
1250228|NCT00510289|Primary|Number of Subjects Achieving Hematological Response|Hematological response is defined as the number of subjects who achieve either a complete response (CR), Partial response (PR) or Hematologic improvement.(HI). HI is defined as peripheral blood counts with hemoglobin ≥11 g/dL, absolute neutrophil count ≥1x10(9)/L and platelet count ≥100x10(9)/L, and normal bone marrow morphology with no evidence of dysplasia or blasts. CR is defined as the disappearance of all signs and symptoms related to disease, along with HI. PR is defined as fulfilling the criteria for CR in the peripheral blood but blasts decreasing by 50% or more in the bone marrow or to a less advanced WHO classification pretreatment.|During treatment - up to a maximum of 5 years|There were 16 subjects enrolled in the trial. 9 subjects refused further bone marrow biopsy to assess response to therapy. Therefore, there were 7 evaluable subjects. One subject experienced PR|||participants|||Number
1250229|NCT00510276|Secondary|Strong Responders by Baseline Smoking Status|Baseline smoking status was recorded and associations to response to treatment were determined. Strong response was defined as 40% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||participants|||Number
1250230|NCT00510276|Secondary|Responders by Baseline Smoking Status|Baseline smoking status was recorded and associations to response to treatment were determined. Response was defined as 25% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||participants|||Number
1250231|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)|Used to determine the level of daytime sleepiness. The ESS is a self-rated questionnaire with 8 items that describe normative daily situations known to vary in their soporific qualities. Subjects rate the likelihood of dozing off or falling asleep in each of these situations. Each item is rated on a 4-point scale from 0 (would never doze) to 3 (high chance of dozing). The item scores are summed to produce a total score (range of 0-24). Score >10 (95th percentile) are considered to be suggestive of significant daytime sleepiness.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250232|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section|The BRIEF-A Working Memory assesses an individuals' memory function in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250233|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section|The BRIEF-A Task Monitor assesses an individuals's ability to monitor a task in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250234|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section|The BRIEF-A Self Monitor assesses an individuals' capacity to self monitor in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250285|NCT00510146|Secondary|Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||gram/Liter||Standard Deviation|Mean
1250235|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section|The BRIEF-A Shift assess an individuals' shifting between different behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250236|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section|The BRIEF-A Plan/Organize asseses an individuals' capabilities to plan and organize in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250237|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section|The BRIEF-A Organization of Materials assesses an individuals' organizing skills in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250238|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section|The BRIEF-A Negativity asseses an indivduals' perceived negativity in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 10.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250239|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section|BRIEF-A Metacognition subscale is a standardized measure assessing individual's ability to systematically solve problems via planning and organization while sustaining these task-completion efforts in active working memory. Form is designed to be completed by adults, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior never observed, 2=behavior sometimes observed, and 3=behavior often observed - higher ratings indicate greater perceived impairment. Total score ranges from 40 to 120.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250240|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section|The BRIEF-A Initiate rates an individual's initiative behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250241|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section|The BRIEF-A Inhibit rates an individual's inhibition in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250286|NCT00510146|Secondary|Change From Baseline to Endpoint in Weight (Open-Label Phase)||Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||kilograms||Standard Deviation|Mean
1250242|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section|Standardized measure assessing adult executive functioning/self-regulation in his/her everyday environment. Extent to which respondent answers additional items in an unusual and infrequent direction. Form is designed to be completed by adults 18-90 years of age, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. Total score ranges from 0 to 5.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250243|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section|The BRIEF-A Inconsistency rates the behavioral inconsistency displayed by the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 20.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250244|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score|The BRIEF-A GEC rates the global executive composite of the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 75 to 225.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250245|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score|The BRIEF-A emotional control subscale assesses an individuals emotional control in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250246|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score|The BRIEF-A behavioral regulation subscale measures an individuals control over behavior in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 30 to 90.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250247|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report|26-item driving survey completed by someone other than the patient/driver. Examples of driving behaviors included in the survey match those listed in the Self-Report version of the scale. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items and ranges from 26 to 104.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250248|NCT00510276|Primary|Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint|CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|Baseline, Week 12|Intent-to-treat population was analyzed, including all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250249|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report|26 item self-rated driving survey with examples of driving behaviors, e.g.: putting on seat belt, driving within speed limits, yielding the right of way to other drivers. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items. A driving history is completed by self-report the first time a rater completes the Driving Behavior Survey (Self-Report). The total score ranges from 26 to 104.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250250|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)|Patient completed scale that consists of 21 items that examine behavior and subjective perception, including satisfaction, self-perception and motivation in participating in and maintaining relationships with family and friends, satisfaction in work, home and leisure activities, and intellectual interests. Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range from 0 to 60.|Baseline, 12 weeks|Analyzed was a intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250251|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)|The FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250252|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of joints that have been consumed.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||number of joints per day||Standard Error|Least Squares Mean
1250253|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of nicotine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||number of nicotine products per day||Standard Error|Least Squares Mean
1250254|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of recreational drugs other than marijuana an individual consumed and is expressed as the ratio of number of days on which drugs were used over the total number of days, resulting in a total score ranging from 0 to 1. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||ratio||Standard Deviation|Mean
1250255|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of caffeine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||number of caffeinated drinks per day||Standard Error|Least Squares Mean
1250256|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||number of alcoholic drinks per day||Standard Error|Least Squares Mean
1250257|NCT00510276|Secondary|Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score|"AAQOL-29: Patient-reported outcome measure examining disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.~CAARS-Inv:SV: Inattention subscale, Impulsivity subscale, and ADHD Index. Each item is scored on a 0 to 3 scale, assessing symptom severity over the past week. The total score is the sum of all subscale scores."|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||correlation coefficient|||Number
1250258|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)|21-item self-reported screening tool for measuring anxiety severity. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely; I could barely stand it). Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Patients record how much they have been bothered by each symptom during the past week, including the day the questionnaire is administered. The total score ranges from 0 to 63.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250259|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)|Rating scale for severity of depressive mood symptoms, administered by the investigator. The scale consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score is the sum of the 10 items and the score ranges from 0 to 60. Higher scores denote more severe depressive symptoms.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250260|NCT00510276|Secondary|Endpoint Scores in Patient Global Impression - Improvement (PGI-I)|7-point scale modeled after the CGI on which patients rate any change in their overall status that they had experienced since beginning the study drug. The score on this scale ranges from 1 (very much improved) to 7 (very much worse).|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250261|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score|30-item patient-reported scale with 3 subscales: Inattention subscale, Hyperactivity-Impulsivity subscale, and ADHD Index. 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each individual item is scored on a 0 to 3 scale (0 = not at all, never; 1 = just a little, once in a while; 2 = Pretty much, often; 3 = very much, very frequently). The rating scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|Baseline, 12 weeks|An intent-to-treat population was analyzed using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250262|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)|Single-item clinician rating of the clinician’s assessment of the patient’s severity of the ADHD symptoms in relation to the clinician’s total experience with ADHD patients. Severity is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). The total score ranges from 1 to 7.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250263|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250264|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses the psychological health. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250265|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses life productivity. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250266|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale|"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale asseses quality of relationships. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|Intent-to-treat population was used for analysis. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250287|NCT00510146|Secondary|Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||millimeters of mercury||Standard Deviation|Mean
1250267|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score|"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|Analyzed was an intent-to-treat population. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
1250268|NCT00510224|Secondary|Pre Versus Post Treatment Mitogenic Effects.||12 Weeks|The trial was closed for futility after no PSA responses were observed among the first 13 patients, and this analysis was not performed||||||
1250269|NCT00510224|Secondary|Grade 4-5 Adverse Events||12 weeks||||Adverse Events|||Number
1250270|NCT00510224|Secondary|Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.|Serum was batched and IGF and IGFBP levels were assayed at one time at the end of the study using an enzyme-linked immunoabsorbent assay (ELISA) method by Diagnostic Systems Laboratories (Webster, TX).|Baseline, 12 weeks||||percent change||Full Range|Median
1250271|NCT00510224|Primary|PSA Response|Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.|12 weeks|n=27 was determined to be sufficient to test for a 20% PSA response proportion compared with a null hypothesis of 5%. A two-stage design was employed to carry out an interim analysis for efficacy. As no patient showed a PSA decline among the first 13 accrued after 3 cycles (the first evaluation of PSA response), accrual was discontinued|||Participants|||Number
1250272|NCT00510146|Secondary|Number of Participants With Adverse Events (Open-Label Phase)|Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.|||participants|||Number
1250273|NCT00510146|Secondary|Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase)|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).|Endpoint (Week 24)|Total participants in the open-label extension phase.|||percentage of participants|||Number
1250274|NCT00510146|Secondary|Change From Baseline to Endpoint in Heart Rate (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||beats per minute||Standard Deviation|Mean
1250275|NCT00510146|Secondary|Change From Baseline to Endpoint in ECG (Open-Label Phase)|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).|Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||milliseconds||Standard Deviation|Mean
1250276|NCT00510146|Secondary|Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||millimole/Liter||Standard Deviation|Mean
1250277|NCT00510146|Secondary|Change From Baseline to Endpoint in Uric Acid (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||micromole/Liter||Standard Deviation|Mean
1250278|NCT00510146|Secondary|Change From Baseline to Endpoint in Prolactin (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||microgram/Liter||Standard Deviation|Mean
1250279|NCT00510146|Secondary|Change From Baseline to Endpoint in Platelet Count (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||billion cells per liter (BILL/L)||Standard Deviation|Mean
1250280|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||millimole/Liter of iron (Fe)||Standard Deviation|Mean
1250281|NCT00510146|Secondary|Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||trillion cells per liter (Tril/L)||Standard Deviation|Mean
1250282|NCT00510146|Secondary|Change From Baseline to Endpoint in Creatinine (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||micromole/Liter||Standard Deviation|Mean
1250283|NCT00510146|Secondary|Change From Baseline to Endpoint in Chloride (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||millimole/Liter||Standard Deviation|Mean
1250284|NCT00510146|Secondary|Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||units/Liter||Standard Deviation|Mean
1250288|NCT00510146|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase)|EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.|Endpoint (Week 24)|Participants who entered Open-Label Phase with a normal baseline and at least one post-baseline result.|||percentage of participants|||Number
1250289|NCT00510146|Secondary|Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase)|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the Open-Label Extension. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.|||percentage of participants|||Number
1250290|NCT00510146|Secondary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1250291|NCT00510146|Secondary|Percentage of Participants With Recovery (Open-Label Phase)|Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in open-label extension phase.|||percentage of participants|||Number
1250292|NCT00510146|Secondary|Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase)|Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in open-label extension phase.|||percentage of participants|||Number
1250293|NCT00510146|Secondary|Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.|||percentage of participants|||Number
1250294|NCT00510146|Secondary|Number of Participants With Adverse Events (Acute Phase)|Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.|Baseline through Week 6 (Acute Phase)|All enrolled participants in Acute Phase|||participants|||Number
1250295|NCT00510146|Secondary|Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase)|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors.|Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1250296|NCT00510146|Secondary|Change From Baseline to Endpoint in Heart Rate (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||beats per minute (bpm)||Standard Deviation|Mean
1250297|NCT00510146|Secondary|Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase)|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).|Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||milliseconds||Standard Deviation|Mean
1250298|NCT00510146|Secondary|Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||ratio||Standard Deviation|Mean
1250299|NCT00510146|Secondary|Change From Baseline to Endpoint in Prolactin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||microgram/Liter||Standard Deviation|Mean
1250300|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||millimole/Liter of iron (Fe)||Standard Deviation|Mean
1250301|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percent of glycosylated hemoglobin||Standard Deviation|Mean
1250303|NCT00510146|Secondary|Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||trillion cells per liter ( TRIL/L)||Standard Deviation|Mean
1250304|NCT00510146|Secondary|Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||micromole/Liter||Standard Deviation|Mean
1250305|NCT00510146|Secondary|Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units/Liter||Standard Deviation|Mean
1250306|NCT00510146|Secondary|Change From Baseline to Endpoint in Albumin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||gram/Liter||Standard Deviation|Mean
1250307|NCT00510146|Secondary|Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||millimole/Liter||Standard Deviation|Mean
1250308|NCT00510146|Secondary|Change From Baseline to Endpoint in Weight (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||kilograms||Standard Deviation|Mean
1250309|NCT00510146|Secondary|Change From Baseline to Endpoint in Blood Pressure (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||mmHg (millimeters of mercury)||Standard Deviation|Mean
1250310|NCT00510146|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase)|EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.|Endpoint (Week 6)|Participants with a normal baseline and an endpoint result.|||percentage of participants|||Number
1250311|NCT00510146|Secondary|Percentage of Participants With Emergence of Mania During the Study (Acute Phase)|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline through Endpoint (Week 6)|Intention-to-treat (ITT) population|||percentage of participants|||Number
1250312|NCT00510146|Secondary|Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase)|In the MINI Substance Dependence and Abuse Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current non-alcohol substance use dependence or abuse.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
1250313|NCT00510146|Secondary|Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase)|In the MINI Alcohol Abuse and Dependence Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current alcohol dependence or abuse.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
1250314|NCT00510146|Secondary|Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase)|In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
1250315|NCT00510146|Secondary|Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase)|In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
1250316|NCT00510146|Secondary|Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase)|In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
1250435|NCT00509236|Secondary|Number of Participants With Symptomatic Hypoglycemic Adverse Events|A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.|54 Week Treatment Period + 28 days|All randomized participants.|||Participants|||Number
1250317|NCT00510146|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1250318|NCT00510146|Secondary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1250319|NCT00510146|Secondary|Percentage of Participants With Recovery (Acute Phase)|Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through Endpoint (Week 6 )|Intention-to-treat (ITT) population; all randomized participants.|||percentage of participants|||Number
1250320|NCT00510146|Secondary|Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)|CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1250321|NCT00510146|Secondary|Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase)|Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through Endpoint (Week 6)|Intention-to-treat (ITT) population; all randomized participants.|||percentage of participants|||Number
1250322|NCT00510146|Secondary|Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)|Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Endpoint (Week 6)|Intention-to-treat (ITT) population; all randomized participants.|||percentage of participants|||Number
1250323|NCT00510146|Primary|Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1250324|NCT00510068|Secondary|Plasma Angiogenesis Marker: Vascular Endothelial Growth Factor (VEGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
1250325|NCT00510068|Secondary|Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
1250326|NCT00510068|Secondary|Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 1 (sVEGFR1)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
1250327|NCT00510068|Secondary|Plasma Angiogenesis Marker: Placental Growth Factor (PLGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
1250328|NCT00510068|Secondary|Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
1250329|NCT00510068|Secondary|Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier|Time to definitive worsening is defined as a definitive increase in performance status from a baseline of 0 or 1 to WHO >= 2, or from a baseline value of 2 to WHO >= 3. If no earlier deterioration, patients were censored at the end of follow-up or at the start of further antineoplastic therapy. Rates of patients with no deterioration at 3 and 6 months were computed using Kaplan-meier method. Grade 0: Able to carry out all activity without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to do light work; Grade 2: Ambulatory & capable of all self-care but unable to carry out any work. Up & about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled & cannot carry on any self-care; totally confined to bed or chair.|3 months, 6 months|The Full Analysis Set (FAS) consists of all patients who were randomized.|||% of participants with no deterioration|||Number
1250330|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. Values for tmax where summarized in median (range).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.|||h||Full Range|Median
1250331|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: CL/F|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter clearance of distribution expressed as a function of bioavailability (CL/F).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.|||L/h||Standard Deviation|Mean
1250332|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.|||ng/mL||Standard Deviation|Mean
1250333|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. This PK parameter is area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t last).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.|||ng.h/mL||Standard Deviation|Mean
1250334|NCT00510068|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation|The open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.|||Participants|||Number
1250335|NCT00510068|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation|The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment.|||Participants|||Number
1250336|NCT00510068|Secondary|Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response|"Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be 'Elevated' otherwise considered as Non-elevated. An ‘early response’ (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors."|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.|||Months||95% Confidence Interval|Median
1250337|NCT00510068|Secondary|Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response|"Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated' otherwise considered as Non-elevated. An ‘early response’ (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors."|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.|||Months||95% Confidence Interval|Median
1250354|NCT00509925|Secondary|Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)|Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
1250338|NCT00510068|Secondary|Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%|The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, > 2% to less than or equal to 5% and > 5%.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.|||Months||95% Confidence Interval|Median
1250339|NCT00510068|Secondary|Overall Survival|Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period.|Baseline, to death- no time limit|The Full Analysis Set (FAS) included all randomized patients.|||Months||95% Confidence Interval|Median
1250340|NCT00510068|Secondary|Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})|Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consists of all patients who were randomized.|||Percentage of participants||95% Confidence Interval|Number
1250341|NCT00510068|Primary|Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology|Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consists of all patients who were randomized.|||Months||95% Confidence Interval|Median
1250342|NCT00509925|Secondary|Hypoglycaemic Episodes, Diurnal/Nocturnal|Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.|Weeks 0-32|The safety analysis set included all randomised and exposed subjects.|||episodes|||Number
1250343|NCT00509925|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in the study.|Weeks 0-32|The safety analysis set included all randomised and exposed subjects.|||episodes|||Number
1250344|NCT00509925|Secondary|Fasting Plasma Glucose|Fasting plasma glucose (FPG) after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||mmol/L||Standard Deviation|Mean
1250345|NCT00509925|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated haemoglobin A1c (HbA1c) after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||percentage of total haemoglobin||Standard Deviation|Mean
1250346|NCT00509925|Secondary|Hormonal Assessment: Leptin|Leptin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||ng/ml||Standard Deviation|Mean
1250347|NCT00509925|Secondary|Hormonal Assessment: Resistin|Resistin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||ng/ml||Standard Deviation|Mean
1250348|NCT00509925|Secondary|Hormonal Assessment: Insulin-like Growth Factor-1|Insulin-like growth factor-1 (IGF-1) levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||ng/ml||Standard Deviation|Mean
1250349|NCT00509925|Secondary|Hormonal Assessment: Adiponectin|Adiponectin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||ng/ml||Standard Deviation|Mean
1250350|NCT00509925|Secondary|Waist:Hip Ratio|At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||percentage of hip circumference||Standard Deviation|Mean
1250351|NCT00509925|Secondary|Fat Mass|Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kg||Standard Deviation|Mean
1250352|NCT00509925|Secondary|Lean Body Mass|Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kg||Standard Deviation|Mean
1250355|NCT00509925|Secondary|Component of Total Energy Expenditure: Physical Activity Thermogenesis|Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32).|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
1250356|NCT00509925|Primary|Total Energy Expenditure, Dietary Record Method|The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE.|Weeks 14-16, weeks 30-32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
1250357|NCT00509925|Secondary|Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)|Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual’s average daily food intake.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
1250358|NCT00509925|Secondary|Component of Total Energy Expenditure: Resting Energy Expenditure (REE)|Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
1250359|NCT00509925|Primary|Total Energy Expenditure, Double-labelled Water Method|Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure.|Weeks 14-16, weeks 30-32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
1250360|NCT00509899|Secondary|Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG performance status measures patients' functional status on the following scale:~0=Fully active, no restrictions;~1=Restricted in physically strenuous activity but ambulatory, able to carry out light work;~2=Ambulatory and capable of all selfcare, unable to carry out any work activities; Up and about > 50% of waking hours;~3=Limited selfcare, confined to bed or chair more than 50% of waking hours;~4=Completely disabled. Totally confined to bed or chair;~5=Dead.~Data reported indicate the number of participants with a change from Baseline score of -2, -1, 0 and 1."|Baseline and Week 24|Intent-to-treat population for patients who had reached each time point and for whom data was available.|||participants|||Number
1250361|NCT00509899|Secondary|Change From Baseline in Body Weight Over Time||Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60.|Intent-to-treat population for patients who had reached each time point and for whom data was available.|||kg||Standard Deviation|Mean
1250362|NCT00509899|Secondary|Change From Baseline to Week 24 in Health-Related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 24|The safety population included all subjects who received at least 1 dose of study medication, and for whom data was available at both time points. The EORTC QLQ C30 was implemented by protocol amendment and as a result this data are available for only approximately 50% of the enrolled patients.|||units on a scale||Standard Deviation|Mean
1250363|NCT00509899|Secondary|Change From Baseline in Myelofibrosis Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF). Abdominal discomfort, itching, muscle or bone pain, and night sweats are prominent and troubling symptoms in patients with MF. Therefore, the MFSAF-derived responses for these symptoms were analyzed as a total symptom score. Each symptom was assessed on a scale from 0 (absent), 1 (most favorable) to 10 (worst). The total symptom score is a sum of the individual scores and ranges from 0-40. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.|Baseline and Week 24|Intent-to-treat population for whom data was available. The MFSAF was implemented by protocol amendment while the study was ongoing. Hence data are available for only approximately 50% of enrolled patients. This analysis includes patients with a Baseline total symptom score ≥ 0; 8 patients were excluded because they had a Baseline score = 0.|||scores on a scale||Standard Deviation|Mean
1250396|NCT00509587|Secondary|Duration of Objective Response||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years|Duration of objective response was not analyzed for 1 patient who achieved PR||||||
1250598|NCT00507559|Secondary|Effectiveness: Thrombosis|Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure|5 years|Events classified by the clinical events committee as thrombosis in device, embolism, device occlusion, vascular occlusion and thrombosis were included in the number of patients affected|||participants|||Number
1250364|NCT00509899|Secondary|Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time|"Spleen volume was assessed in a subgroup of 27 patients using magnetic resonance imaging (MRI) scans (or computed tomography (CT) scans in patients who were not candidates for MRI) of the abdomen in order to allow objective measurement of spleen volume using standard estimation techniques.~For each visit, patients who had a missing value at the visit or dropped out of the study due to any reason prior to the visit were considered as not having achieved the ≥35% reduction in spleen volume."|Baseline, Weeks 4, 12, 24 and 48|Patients with at least 1 Spleen-Volume Measurement. Patients who had not reached the visit were excluded from the analysis. In addition, at Week 48, 5 patients who did not have MRI measurement due to a protocol amendment were considered as not evaluable and were excluded from the analysis.|||percentage of participants|||Number
1250365|NCT00509899|Secondary|Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time|For each visit, patients who had a missing value at the visit, dropped out of the study due to any reasons prior to the visit or had non-palpable spleen at baseline and then became palpable at the time of the visit were all considered as having not achieved the ≥ 50% reduction in spleen palpation length.|Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60|Intent to treat population. A total of 16 patients had either a splenectomy prior to study entry, missing Baseline spleen values or had spleen lengths reported as 0 cm and were excluded.|||percentage of participants|||Number
1250366|NCT00509899|Primary|Percentage of Participants With Clinical Improvement (CI) Over Time|"Clinical improvement was defined according to the International Working Group Myelofibrosis Research and Treatment criteria, and required 1 of the following:~A ≥ 2 g/dL increase in Hemoglobin level or becoming transfusion independent;~Either a ≥ 50% reduction in palpable splenomegaly if spleen was ≥ 10 cm at Baseline or a spleen palpable at > 5 cm at Baseline becomes not palpable;~A ≥ 100% increase in platelet count and an absolute platelet count of ≥ 50,000 x 10^9/L or~A ≥ 100% increase in absolute neutrophil count (ANC) and an ANC of ≥ 0.5 x 10^9/L."|Week 12, 24, 36, 48 and 60|The intent-to-treat population included all patients who received at least 1 dose of study medication and had at least 1 follow-up assessment for safety and efficacy. N = the number of patients who had clinical response assessed during the time interval.|||percentage of participants|||Number
1250367|NCT00509899|Primary|Number of Participants With Adverse Events (AEs)|"Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline.~Treatment-Related AEs are those with a definite, probable, possible or missing causality.~A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above.~A severe or life-threatening AE is based on intensity, according to National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) v3.0."|From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.|Safety population included all patients who received at least 1 dose of study medication.|||participants|||Number
1250368|NCT00509873|Post-Hoc|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6|"Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
1250369|NCT00509873|Secondary|Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6|Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
1250370|NCT00509873|Secondary|Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6|Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
1250371|NCT00509873|Secondary|Percentage of Patients With Microbiological Cure at Day 6|Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture)|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
1250397|NCT00509587|Primary|Number of Participants With Partial and Complete Response.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 3 years||||participant|||Number
1250372|NCT00509873|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
1250373|NCT00509795|Secondary|Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)|CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.|Baseline and at week 52|FAS population used for analysis.|||mm^2||Standard Deviation|Mean
1250374|NCT00509795|Secondary|Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline and at Week 52|FAS population used for analysis.|||scores on a scale||Standard Deviation|Mean
1250375|NCT00509795|Secondary|Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|FAS population used for analysis.|||percentage of patients|||Number
1250376|NCT00509795|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|FAS population used for analysis.|||letters read||Standard Deviation|Mean
1250377|NCT00509795|Primary|Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)|Defined “maintenance of vision” as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.|Baseline and at week 52|PPS population used for analysis.|||percentage of patients|||Number
1250378|NCT00509769|Secondary|Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Months||95% Confidence Interval|Median
1250379|NCT00509769|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Months||95% Confidence Interval|Median
1250380|NCT00509769|Secondary|Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Percentage of patients||95% Confidence Interval|Number
1250398|NCT00509496|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|6 years||||Participants|||Number
1250619|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 48|The change from baseline in HBV DNA at Week 48 was analyzed.|Baseline to Week 48|Participants in the Full Analysis Set with evaluable change data at Week 48 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
1250381|NCT00509769|Secondary|Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Months||95% Confidence Interval|Median
1250382|NCT00509769|Secondary|Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Months||95% Confidence Interval|Median
1250383|NCT00509769|Primary|Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Percentage of patients||95% Confidence Interval|Number
1250384|NCT00509665|Secondary|Correlation of Cytotoxicity With Apoptosis in Cancer Cells||prior to first dose of drug and every 6 weeks for up to 6 months|Data for this endpoint was not collected||||||
1250385|NCT00509665|Secondary|Correlation of Cytoxocity With Cell-cycle Arrest||prior to first dose of drug and every 6 weeks up to 6 months|data for this endpoint was not collected||||||
1250386|NCT00509665|Secondary|Number of Patients Who Had Greater Than Grade 2 Toxicity||from time of initial treatment until end of study, an average of 6 months|Patients who were treated on study and had greater than grade 2 toxicity.|||Participants|||Count of Participants
1250387|NCT00509665|Secondary|Overall Survival||From the time of initial therapy until the time of death.||||Months||95% Confidence Interval|Median
1250388|NCT00509665|Secondary|Progression-free Survival||Through the end of follow up, for an average of 8 months|Only patients who had re-staging scans are included in the number of participants analyzed.|||months||95% Confidence Interval|Median
1250389|NCT00509665|Secondary|Duration of Response||Every 6 weeks for up to 8 months|data for this endpoint was not collected||||||
1250390|NCT00509665|Primary|Response Rate|Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.|Every 6 weeks from the time of initial treatment for up to 8 months|patients who were on study at the time of response assessment|||participants|||Number
1250391|NCT00509600|Primary|Patient Response|Response is defined as a WBC < 15,000 and platelets > 75,000 at 12 weeks; toxicity is defined as a grade 3 or worse infection or non-hematologic toxicity within the first 4 weeks.|12 weeks|No analysis as only registrant inevaluable, and trial terminated early due to poor enrollment.||||||
1250392|NCT00509587|Secondary|Adverse Events Graded According to the NCI CTCAE Version 3.0|grade 3– 4 toxicities - transaminitis, hypertension, and neutropenia in three patients each (14% each) and grade 3 gastrointestinal hemorrhage in one patient (5%).|Up to 3 years||||percentage of patients|||Number
1250393|NCT00509587|Secondary|Overall Survival|Computed using the Kaplan-Meier method.|Up to 3 years||||months||95% Confidence Interval|Median
1250394|NCT00509587|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions|6 months||||percentage of patients||95% Confidence Interval|Number
1250395|NCT00509587|Secondary|Duration of Stable Disease||From the start of the treatment until the criteria for progression are met, assessed up to 3 years||||months||95% Confidence Interval|Median
1250399|NCT00509496|Primary|Clinical Tumor Regression.|Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD)is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|20 months||||Participants|||Number
1250400|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).~Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.~Change from Baseline"|1 Month|Data at 1 month follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
1250401|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100).~Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.~Change from Baseline"|2 Week|Data at 2-week follow up visit|||units on a scale|limbs|Standard Deviation|Mean
1250402|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).~Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.~Change from Baseline"|1 Week|Data at one week follow up visit|||units on a scale|limbs|Standard Deviation|Mean
1250403|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).~Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.~Change from Baseline"|48 Hours|Data at 48 hrs follow up visit|||units on a scale|limbs|Standard Deviation|Mean
1250404|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):~0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|1 Month|Data at 1- month follow up visit|||units on a scale|limbs|Standard Deviation|Mean
1250405|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):~0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|2 Weeks|Data at 2 week follow up visit|||units on a scale|limbs|Standard Deviation|Mean
1250406|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):~0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|1 Week|Data at 1-week follow up visit|||units on a scale|limbs|Standard Deviation|Mean
1250407|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):~0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|48 Hours|Data at 48 hours for follow up visit|||units on a scale|limbs|Standard Deviation|Mean
1250408|NCT00509392|Primary|Complications|Sequelae at any follow-up|1 month|Data up to one month follow up visit|||limbs|limbs||Count of Units
1250409|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None~<25%~25-50%~50-75%~75-100%~Above or below tx segment"|1 Month post treatment (no baseline)|Data available at 1- month follow-up visit|||limbs|limbs||Number
1250410|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None~<25%~25-50%~50-75%~75-100%~Above or below tx segment"|2 Weeks post treatment (no baseline)|Intent to treat/ SP: Data available at 2-week follow-up visit|||limbs|limbs||Number
1250411|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None~<25%~25-50%~50-75%~75-100%~Above or below tx segment"|1 Week post treatment (no baseline)|Data available at 1-week follow-up visit|||limbs|limbs||Number
1250412|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None~<25%~25-50%~50-75%~75-100%~Above or below treated (tx) segment"|48 Hours post treatment (no baseline)|Data available at 48hrs follow-up visit|||limbs|limbs||Number
1250413|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|1 Month|Data available at 1 month follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
1250414|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|2 Weeks|Data available at 2-week follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
1250415|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|1 Week|Data available at 1-week follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
1250416|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|48 Hour|Data available at 48hr visit|||units on a scale|limbs|Standard Deviation|Mean
1250417|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|1 Month|Data available at 1 month follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
1250418|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|2 Weeks|Data available at 2-week follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
1250419|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|1 Week|Data available at 1-week follow-up visit.|||units on a scale|limbs|Standard Deviation|Mean
1250420|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|48 Hour|Data available at 48 hr follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
1250421|NCT00509366|Secondary|Drug Sensitivity Quartiles for Cisplatin and Pemetrexed|Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity.|3 years|This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates.||||||
1250434|NCT00509236|Primary|Number of Participants With Clinical Adverse Events|Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.|54 Week Treatment Period + 28 days|All randomized participants.|||Participants|||Number
1250422|NCT00509366|Secondary|Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)|The outcome measure is mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L instrument consists of 34 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-being (FWB) and additional lung specific concerns (LCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and LCS scores (7 items), which each have a possible range between 0 and 28. Therefore, TOI ranges from 0 to 84.|Baseline, Every 21 days for a maximum of 6 cycles|Of the 50 patients assigned treatment, only 32 patients completed the FACT-L assessment at baseline and at least one follow-up.|||units on a scale||Standard Error|Mean
1250423|NCT00509366|Secondary|Median Time to Progressive Disease|Median time to progressive disease was defined as the time from enrollment to the the time at which 50% of patients had experienced disease progression. Enrollment is defined as having successful genomic analysis and start of chemotherapy. Time was censored at date of death for patients who have not had documented disease progression, at first available date of other anti-tumor therapy for patients who were either administered other anti-tumor therapy prior to documented disease progression or administered other anti-tumor therapy without documented disease progression, and at last date of followup if neither non-protocol therapy was administered nor progression documented.|1 Year|Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.|||months||95% Confidence Interval|Number
1250424|NCT00509366|Primary|1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients|One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive.|1 year|Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.|||percentage of treated patients||95% Confidence Interval|Number
1250425|NCT00509288|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed listing of adverse events, see the adverse event module.|57 months||||Participants|||Number
1250426|NCT00509288|Primary|Clinical Tumor Regression.|Tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|7/5/07-4/23/09||||Participants|||Number
1250427|NCT00509262|Secondary|Change From Baseline in Body Weight at Week 54||Baseline to Week 54|All participants as treated (APaT) population included participants who had both baseline and Week 54 data (excluding data after initiation of glycemic rescue therapy).|||kg||Standard Error|Least Squares Mean
1250428|NCT00509262|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54||Baseline to Week 54|The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.|||mg/dL||Standard Deviation|Mean
1250429|NCT00509262|Primary|Percentage of Participants With Hypoglycemic Events|Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.|Baseline up to 28 days following the last dose of study therapy|All participants as treated (APaT) population included all randomized participants who took at least one dose of study therapy.|||percentage of participants|||Number
1250430|NCT00509262|Primary|Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54|A1C represents percentage of glycosylated hemoglobin.|Baseline to Week 54|The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.|||Percent of glycosylated hemoglobin||Standard Deviation|Mean
1250431|NCT00509249|Primary|Hematological Response Rate|Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.0x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still > 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.|Up to 3 years||||participants|||Number
1250432|NCT00509236|Secondary|Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment|Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.|||Percent hemoglobin A1c||95% Confidence Interval|Least Squares Mean
1250433|NCT00509236|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.|||mg/dL||Standard Deviation|Mean
1250436|NCT00509236|Primary|Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment|Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.|||Percent hemoglobin A1c||Standard Deviation|Mean
1250437|NCT00509223|Primary|HbA1c Change|Month 6 change in HbA1c (%)|Baseline to Month 6|The following definition was applied to the primary endpoint: included in analysis were all participants that had at least 1 follow-up HbA1c value in addition to the Baseline HbA1c were considered.|||HbA1c percent||Standard Deviation|Mean
1250438|NCT00509197|Secondary|Change in Provocative Concentration of Methacholine Inducing a 20% Fall in FEV1 (PC20)|Change in provocative concentration of methacholine inducing a 20% fall in FEV1 (PC20) after fluticasone or placebo treatment|Four weeks||||mg/ml||Standard Deviation|Mean
1250439|NCT00509197|Secondary|Change in Forced Expiratory Volume in One Second (FEV1)|Change in forced expiratory volume in one second (FEV1) after fluticasone or placebo treatment.|Four weeks||||L||Standard Deviation|Mean
1250440|NCT00509197|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score After 4 Weeks of Treatment|Validated questionnaire assessing quality of life related to asthma after 4 weeks of treatment. The AQLQ is composed of 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The AQLQ score is rated on a 7-point scale (1=maximal impairment, 7=no impairment) to yield a mean score out of 7. The worse the quality of life is , the lower the score is.|Four weeks||||units on a scale||Standard Deviation|Mean
1250441|NCT00509197|Primary|Asthma Control Questionnaire (ACQ) Score After 4 Weeks of Treatment With Inhaled Corticosteroids (ICS) or Placebo|Validated questionnaire assessing asthma control after 4 weeks of treatment with ICS or placebo. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of 7 items and thus ranges between 0 (well controlled) and 6 (extremely poorly controlled) to yield a mean score out of 6. The higher the score, the worst asthma control is.|Four weeks|Intention to treat|||units on a scale||Standard Deviation|Mean
1250442|NCT00509106|Secondary|Evaluate Safety||first dose, throughout the treatment period, and up to the TOC visit|||||||
1250443|NCT00509106|Secondary|Microbiological Reinfection/Recurrence at LFU||21 to 35 days after last dose of study drug|||||||
1250444|NCT00509106|Secondary|Clinical Relapse at Late Follow Up (LFU) Visit||21-35 days after last dose of study drug|||||||
1250445|NCT00509106|Secondary|Clinical and Microbiological Response by Pathogen at TOC||8-15 days after last dose of study drug|||||||
1250446|NCT00509106|Secondary|Overall Clinical and Radiographic Success Rate at TOC||8-15 days after last dose of study drug|||||||
1250447|NCT00509106|Secondary|Microbiological Success Rate at TOC||8-15 days after last dose of study drug|||||||
1250448|NCT00509106|Secondary|Clinical Response at End of Therapy (EOT)||Last day of study drug administration|||||||
1250449|NCT00509106|Primary|Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug|||||||
1250450|NCT00509106|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population|"Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary~Failure: Any of the following:~Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy~Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia~Death wherein pneumonia (ie,CABP) was considered causative~Indeterminate: Inability to determine an outcome"|8-15 days after last dose of study drug|The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.|||participants|||Number
1250451|NCT00509067|Secondary|MATRICS Verbal Learning and Memory|The measure of verbal learning and memory is the Hopkins Verbal Learning Test. The score for each subject is the sum of the total number of words recalled correctly for Trials 1, 2, and 3. The measure is the mean of these scores at baseline, Week 8, and Week 16.|Measured at Baseline and Weeks 8 and 16|intent to treat|||raw scores||Standard Deviation|Mean
1250452|NCT00509067|Secondary|Clinical Global Impression|The score for each subject was the mean rating on the severity item. The score of the item ranged from 1 (normal) to 7 (among most severely ill).|Measured at Baseline and Weeks 4, 8, 12, and 16|intent to treat|||units on a scale||Standard Deviation|Mean
1250453|NCT00509067|Primary|Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)|The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.|Measured at Baseline and Weeks 4, 8, 12, and 16|intent to treat|||units on a scale||Standard Deviation|Mean
1250665|NCT00507130|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis|||Micrograms per milliliter||Standard Deviation|Mean
1250454|NCT00509041|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to progression or death (up to 3 years)||||weeks||95% Confidence Interval|Median
1250455|NCT00509041|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 3 years)||||weeks||95% Confidence Interval|Median
1250456|NCT00509041|Secondary|Number of Participants With Overall Tumor Response|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Overall tumor response is the total number of CR and PRs."|Duration of study until progression (up to 3 years)||||participants|||Number
1250457|NCT00509041|Primary|24 Week Progression Free Survival|Percentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|24 weeks||||percentage of participants||95% Confidence Interval|Number
1250458|NCT00509028|Secondary|Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline|Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 * (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1).|54 weeks||||Percentage||Standard Deviation|Mean
1250459|NCT00509028|Secondary|Change From Baseline in Disturbance of Night-time Sleep|"Change in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization).~Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable)."|Baseline and 54 weeks||||Disturbances per night||Standard Deviation|Mean
1250460|NCT00509028|Secondary|Change From Baseline in Disturbance of Daily Activities|"Change in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization).~Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable)."|Baseline and 54 weeks||||Disturbances per day||Standard Deviation|Mean
1250461|NCT00509028|Secondary|Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)|Change in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization)|Baseline and 54 weeks||||Puffs per day||Standard Deviation|Mean
1250462|NCT00509028|Secondary|Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)|Change in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization)|Baseline and 54 weeks||||Puffs per day||Standard Deviation|Mean
1250463|NCT00509028|Secondary|Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)|"Change in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization).~Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency."|Baseline and 54 weeks||||Points on a scale||Standard Deviation|Mean
1250464|NCT00509028|Secondary|Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)|"Change in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4.~0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency"|Baseline and 54 weeks||||Points on a scale||Standard Deviation|Mean
1250465|NCT00509028|Secondary|Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal|Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).|54 weeks||||Percentage||Standard Deviation|Mean
1250466|NCT00509028|Secondary|Weight|Weight, change from baseline calculated as (weight at last visit - weight at randomization)|Baseline and 54 weeks||||kilograms||Standard Deviation|Mean
1250467|NCT00509028|Secondary|Height|Height, change from baseline calculated as (height at last visit - height at randomization)|Baseline and 54 weeks||||Centimeters||Standard Deviation|Mean
1250468|NCT00509028|Secondary|Number of Patients With Abnormal Plasma Cortisol Values.|Cut-off value of cortisol is defined as 4 mcg/dL.|54 weeks||||Participants|||Number
1250469|NCT00509028|Secondary|Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator||54 weeks||||Participants|||Number
1250470|NCT00509028|Secondary|Number of Patients With Abnormal Clinical Laboratory Test Values.|"Analysis of haematological, clinical chemistry and urynalysis variables were performed.~Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count.~Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen.~Urinalysis variables: protein, glucose, urobilinogen, occult."|54 weeks||||Participants|||Number
1250471|NCT00509028|Primary|Number of Patients With Adverse Events (AEs).|AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.|54 weeks||||Participants|||Number
1250499|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250472|NCT00509002|Primary|Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy|The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria was used for objective tumor response assessment. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or > new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Response rate estimated by Gehan’s Phase II clinical trial design.|Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal||||Participants|||Count of Participants
1250473|NCT00508924|Primary|Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.|"Composite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30~Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay"|30 Days||||participants|||Number
1250474|NCT00508924|Primary|Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.||5 - 10 min after initial bolus||||second||Inter-Quartile Range|Median
1250475|NCT00508872|Primary|Complete Gross Resection Rate|Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).|Over 4 year study period|Intended analysis was per protocol. Study terminated early, leading to only two (2) patients recruited, one not eligible for study and second inevaluable.||||||
1250476|NCT00508820|Secondary|Platelet Response (Definition 2)|Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)|Duration of treatment (up to 201 weeks)|Full Analysis Set, all enrolled participants|||Participants|||Number
1250477|NCT00508820|Secondary|Platelet Response (Definition 1)|Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L|Duration of treatment (up to 201 weeks)|Full Analysis Set, all enrolled participants|||Participants|||Number
1250478|NCT00508820|Primary|Adverse Events|One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once|Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.|Safety Analysis Set, comprised of all participants who received at least one dose of romiplostim|||participants|||Number
1250479|NCT00508755|Primary|Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES.|Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.|visit 48, following treatment|The sample size for this feasibility study was n=6, constrained by funding limit.|||participants|||Number
1250480|NCT00508742|Secondary|Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age||Month 7, 12, 13, 18, 24|Evaluable culture population; 'n' is number of participants with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.|||percentage of participants||95% Confidence Interval|Number
1250481|NCT00508742|Primary|Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age|A new acquisition was defined as the detection of a serotype (here 6A’ [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.|Month 7 through Month 24|Evaluable culture population included all participants who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1250482|NCT00508716|Primary|Re-hospitalization or Death|Number of participants who are re-hospitalized or die within 90 days of discharge|90 days||||participants|||Number
1250483|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3|Post-Dose 3 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.|||GMT||95% Confidence Interval|Mean
1250484|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2|Post-Dose 2 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.|||GMT||95% Confidence Interval|Mean
1250485|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1|Post-Dose 1 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.|||GMT||95% Confidence Interval|Mean
1250486|NCT00508651|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline|Pre-dose GMT of HAI antibody to HPIV3|Baseline (Day 0 prior to Dose 1)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.|||GMT||95% Confidence Interval|Mean
1250487|NCT00508651|Secondary|Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable|A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Determination of the temperature sensitivity of recovered vaccine-type virus.|Day 0 after Dose 1 to 180 days after the final dose|All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid phenotype data are available|||samples containing vaccine-like virus|Participants||Number
1250488|NCT00508651|Secondary|Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable|A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.|Day 0 after Dose 1 to 180 days after the final dose|All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid genotype data are available|||samples containing vaccine-like virus|Participants||Number
1250489|NCT00508651|Secondary|Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.|||participants|||Number
1250490|NCT00508651|Secondary|Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.|||participants|||Number
1250491|NCT00508651|Secondary|Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.|||participants|||Number
1250492|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250493|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250494|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250495|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250496|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250497|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250498|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250500|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1||Days 0-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250501|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250502|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250503|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250504|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
1250505|NCT00508651|Primary|Number of Participants With Significant New Medical Conditions (SNMCs)|A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 0 through 180 days after final dose|Safety population was randomized participants who received investigational product and had any safety follow-up, including a temperature measurement, SE, AE, concomitant medication use, or follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).|||participants|||Number
1250506|NCT00508651|Primary|Number of Participants With SAEs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participants|||Number
1250507|NCT00508651|Primary|Number of Participants With SAEs After Dose 2|One participant had event of pneumonia after Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participants|||Number
1250508|NCT00508651|Primary|Number of Participants With Serious Adverse Events (SAEs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participant|||Number
1250509|NCT00508651|Primary|Number of Participants With MA-LRIs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participant|||Number
1250510|NCT00508651|Primary|Number of Participants With MA-LRIs After Dose 2||Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participant|||Number
1250511|NCT00508651|Primary|Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participant|||Number
1250512|NCT00508651|Primary|Number of Participants With AEs After Dose 3|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participants|||Number
1250513|NCT00508651|Primary|Number of Participants With AEs After Dose 2|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participants|||Number
1250514|NCT00508651|Primary|Number of Participants With Adverse Events (AEs) After Dose 1|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose).|||participants|||Number
1250515|NCT00508651|Primary|Number of Participants With SEs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.|||participants|||Number
1250516|NCT00508651|Primary|Number of Participants With SEs After Dose 2||Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose|||participants|||Number
1250517|NCT00508651|Primary|Number of Participants With Solicited Adverse Events (SEs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose|||participants|||Number
1250518|NCT00508521|Primary|Fugl-Meyer Upper Limb Coordination Scale (FMUE)|A subscale of the Fugl-Meyer; the Fugl-Meyer Upper Limb Coordination Scale is a measure of movement coordination in and out of synergy patterns for the hemiparetic upper limb; scores range from 0-66, with 0 being the worst score and 66 being the best score.|baseline and after 12 weeks of training||||units on a scale||Standard Deviation|Mean
1250519|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||at the 12th week of follow-up|ITT analysis was used.|||percentage of participants|||Number
1250520|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||at the 4th week of follow-up|ITT analysis was used|||percentage of participants|||Number
1250521|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||over 4 weeks of treatment|ITT analysis was used.|||percentage of participants|||Number
1250522|NCT00508482|Secondary|Time to the First Spontaneous Bowel Movement After the First Treatment||counting by hours|ITT analysis was used|||hours||Standard Deviation|Mean
1250523|NCT00508482|Secondary|Change of Mean Value of Cleveland Clinic Score|Cleveland Clinic Score was assessed by doctors which contains eight items about constipation-related symptoms. Score ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.|over 4 weeks of treatment|ITT analysis was used|||units on a scale||Inter-Quartile Range|Median
1250524|NCT00508482|Secondary|Change of Mean Value of Abdominal Distention|Score of abdominal distention was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of abdominal distention over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of abdominal distention by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used.|||units on a scale||Standard Deviation|Mean
1250525|NCT00508482|Secondary|Change of Mean Value of Stool Consistency|Score of stool consistency was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of stool consistency over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of stool consistency by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used.|||units on a scale||Standard Deviation|Mean
1250526|NCT00508482|Secondary|Change of Mean Value of Incomplete Evacuation|Score of incomplete evacuation was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of incomplete evacuation over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.|over 4 weeks of treatment|ITT analysis was used.|||units on a scale||Inter-Quartile Range|Median
1250527|NCT00508482|Secondary|Change of Mean Value of Straining During Defecating|Score of straining during defecating was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of straining during defecating over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of straining during defecating by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used|||units on a scale||Standard Deviation|Mean
1250528|NCT00508482|Primary|Change of Mean Weekly Spontaneous Bowel Movements|Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.|over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up|Intention-To-Treat(ITT) analysis was used.|||stools/week||Inter-Quartile Range|Median
1250529|NCT00508469|Primary|Adherence|Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.|6 months|Per protocol|||percentage of adherent patients|||Number
1250530|NCT00508404|Secondary|Resection Rate|The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set|||percentage of participants||95% Confidence Interval|Number
1250531|NCT00508404|Secondary|Time to Disease Relapse Following Surgical Intervention|Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set participants who underwent surgery|||months||95% Confidence Interval|Median
1250532|NCT00508404|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
1250574|NCT00508027|Primary|Change in Serum Creatine Kinase Levels|Change in serum creatine kinase (CK) levels after treatment with simvastatin|Baseline, 21 days||||U/L||Standard Deviation|Mean
1250575|NCT00508027|Primary|Change in Hemoglobin Level|Change in plasma hemoglobin (Hb) level after treatment with simvastatin|Baseline, 21 days||||gm/dL||Standard Deviation|Mean
1250533|NCT00508404|Secondary|Duration of Stable Disease|Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set with a best response of SD|||months||95% Confidence Interval|Median
1250534|NCT00508404|Secondary|Time to Disease Progression|Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
1250535|NCT00508404|Secondary|Progression-free Survival|Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, and had evaluable KRAS status data)|||months||95% Confidence Interval|Median
1250536|NCT00508404|Secondary|Time to Initial Objective Response|Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set|||months||95% Confidence Interval|Median
1250537|NCT00508404|Secondary|Duration of Response|Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set with an objective response (CR or PR)|||months||95% Confidence Interval|Median
1250538|NCT00508404|Secondary|Disease Control Rate|"The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST v1.0 criteria as assessed by the Investigator.~Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline."|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks|KRAS Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
1250539|NCT00508404|Secondary|Objective Response by 17 Weeks|The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.|Up to Week 17|KRAS Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
1250540|NCT00508404|Primary|Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.~Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.~Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions."|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks|KRAS Tumor Response Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, had evaluable KRAS status data, and with at least 1 unidimensionally measurable lesion per modified RECIST by the local investigator)|||percentage of participants||95% Confidence Interval|Number
1250541|NCT00508391|Primary|Percent of Subjects That Did Not Experience an Adverse Event That Require Additional Invasive Intervention to Resolve, Specifically Related to the Interventricular Delay Feature of the Lumax HF-T Heart Failure Device|The purpose of primary endpoint two is to evaluate adverse events that require additional invasive intervention to resolve, specifically those events that are directly related to the interventricular delay feature of the Lumax HF-T heart failure device. These adverse events include any software issues related to the programming of the interventricular delay or any event that occurs after optimization of the interventricular delay and that can be directly attributed to the use of the feature.|60 days after enrollment||||Percent of Subjects|||Number
1250576|NCT00508027|Primary|Change in Total Cholesterol Level|Change in serum total cholesterol level after treatment with simvastatin|Baseline, 21 days||||mg/dL||Standard Deviation|Mean
1250577|NCT00508027|Other Pre-specified|Change in Plasma TF Levels|Change in plasma tissue factor (TF) levels after treatment with simvastatin|Baseline, 21 days||||pg/mL||Standard Deviation|Mean
1250578|NCT00508027|Other Pre-specified|Change in Plasma VCAM1 Levels|Change in plasma vascular cellular adhesion molecule-1 levels after treatment with simvastatin|Baseline, 21 days||||ng/mL||Standard Deviation|Mean
1250542|NCT00508391|Primary|"Percentage of Subjects Classified as Not Worsened for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing"|"The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM). The hypothesis is evaluated based on a responder classification. Subjects are classified not worsened if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM. The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used for QOL. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105."|60 days after enrollment|Study utilized an intention-to-treat analysis. 111 out of 122 enrolled subjects completed the primary endpoint follow-up. 106 of these subjects met analysis criteria based on paired quality of life and six-minute walk data at the one and two month visits. Subjects not included in analysis either withdrew consent or had incomplete study measures.|||Percent of Subjects|||Number
1250543|NCT00508274|Secondary|Central Nervous System as First Site of Relapse|Number of participants who have Central Nervous System metastasis as the first site of relapse. CT, Magnetic Resonance Imaging, etc. were used for the assessment.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product|||participants|||Number
1250544|NCT00508274|Secondary|Duration of Response|Duration of response is defined as the time of first documentation of disease response until the date of disease progression or death due to breast cancer, whichever occurs first.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product|||Months||Full Range|Median
1250545|NCT00508274|Secondary|Time to Response|Time to response is defined as the time from first dose date until first documentation of disease response.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product|||Months||Full Range|Median
1250546|NCT00508274|Secondary|Six Months Progression-Free Survival|Six Months Progression-Free Survival is defined as the percentage of surviving participants who are free of disease progression longer than six months (greather than 180 days) after the first start date of study treatment.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||Percentage of participants||95% Confidence Interval|Mean
1250547|NCT00508274|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||Months||Full Range|Median
1250548|NCT00508274|Primary|Clinical Benefit Rate (CBR)|"CBR is defined by the percentage of participants achieving either a confirmed tumor reponse or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A partial response requires a decrease of 30% or more, Progression requires an increase of at least 20%, and Stable disease falls in between these two. All responses have a repeat assessment to confirm the response."|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||Percentage of participants||95% Confidence Interval|Mean
1250549|NCT00508183|Secondary|Healing Rate|Percentage of Participants who had healed by 1 year post-surgery as measured using magnetic resonance imaging. If the tendons were in continuity with no evidence of full-thickness tearing, the repair was considered healed (intact).|1 Year||||percentage of patients|||Number
1250550|NCT00508183|Secondary|Strength Test|Shoulder strength in forward elevation was measured in kg using a portable scale.|2 Years||||kg||Standard Deviation|Mean
1250551|NCT00508183|Secondary|ASES Score|Determination of differences in outcome between the two groups as measured by the American Shoulder and Elbow Surgeons (ASES) score. The ASES score ranges from 0 to 100 with a higher number indicative of better function.|2 Year||||units on a scale||Standard Deviation|Mean
1250552|NCT00508183|Secondary|Constant Score|Differences in outcome between the two groups as measured by the Constant score. The constant score ranges from 1 to 100 with a higher value indicative of better shoulder function.|2 Year||||units on a scale||Standard Deviation|Mean
1250553|NCT00508183|Primary|Western Ontario Rotator Cuff Index (WORC)|Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life (measured by WORC) then patients who undergo a repair with arthroscopic technique using single-row fixation? The WORC scale is from 0% to 100%, with a higher value being indicative of better disease specific quality of life.|2 years||||units on a scale||Standard Deviation|Mean
1250554|NCT00508157|Secondary|Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16|IWQoL-Lite is a 31-item self-report inventory to assess the impact of weight on quality of life among patients with obesity. Subscales include: Physical Function, Self Esteem, Sexual Life, Public Distress and Work. The rescaled IWQoL-Lite Total Score is determined by the sum of the 1 to 5 scores on all 31 items and rescaling this sum to a 0-100 scoring with 0=the poorest and 100=the best quality of life. A change of 7.8 to 12.0 points on the rescaled IWQoL-Lite Total Score=a meaningful improvement. A change of -4.5 to -7.6 on the rescaled IWQoL-Lite Total Score=a meaningful deterioration.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
1250579|NCT00508027|Other Pre-specified|Change in Plasma VEGF Levels|Change in plasma vascular endothelial adhesion molecule-1 levels after treatment with simvastatin|Baseline, 21 days||||pg/mL||Standard Deviation|Mean
1250555|NCT00508157|Secondary|Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16|The SWN-short form is a 20-item self-report instrument that measures subjective well-being under neuroleptics. 10 positive and 10 negative items cover 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). With negative item scores being reversed, Subscale scores range from 4 to 24 and Total score ranges from 20 to 120.|Baseline, Week 4, Week 8,Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
1250556|NCT00508157|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=normal; 7=among the most extremely ill patients). A decrease in value indicates improvement.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
1250557|NCT00508157|Secondary|Median Change From Baseline in Body Mass Index (BMI) Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
1250558|NCT00508157|Secondary|Mean Change From Baseline in Body Weight Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
1250559|NCT00508157|Secondary|Mean Change From Baseline for Fasting Glucose Levels Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
1250560|NCT00508157|Secondary|Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16|Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
1250561|NCT00508157|Secondary|Number of Participants Remaining on Metabolic Syndrome at Week 16|Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study.|Week 16|LOCF, Safety Sample For handling missing values, the metabolic syndrome is assumed to be ongoing unless there is enough data to support the resolution of the metabolic syndrome.|||participants|||Number
1250562|NCT00508157|Primary|Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16|Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.|Baseline, Week 16|Last Observation Carried Forward (LOCF) data set, Non-HDL measurements obtained after start of a treatment with a lipid-lowering agent were excluded; last measurement prior was used for LOCF analyses. Baseline data was carried forward for LOCF analysis for subjects for whom no on-treatment measurements for fasting non-HDL cholesterol was available.|||percent change||Standard Error|Mean
1250563|NCT00508144|Primary|Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR)|"Complete Response (CR): Complete disappearance of all measurable & non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers & other abnormal lab values.~Partial Response (PR): Applies only to those with at least one measurable lesion. >/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline.~Progression: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician.~Evaluated for symptoms 1-2 times per week while receiving treatment then 2 weeks after stopping study treatment (expected 4 cycles)."|Evaluated with 3 week treatment cycles, up to 4 cycles or 12 weeks|Of 58 eligible participants, only 54 treated were available for response and five (5) experienced an early death, five (5) were later deemed inevaluable, and two had an indeterminate response.|||Participants|||Count of Participants
1250564|NCT00508118|Secondary|Transcranial Doppler Measurements||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
1250565|NCT00508118|Secondary|Cerebral Oximetry Measurements||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
1250566|NCT00508118|Secondary|Bispectral Index Scores (BIS)||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
1250567|NCT00508118|Secondary|Time Points for SSEP Latency and Amplitude Changes||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
1250568|NCT00508118|Secondary|Time Points of EEG Patterns||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
1250569|NCT00508118|Secondary|Temperature at Which Ablation of(SSEP)Occurs||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
1250570|NCT00508118|Secondary|Temperature at Which ECS Occurs||Day of surgery through discharge|No participants analyzed due to study terminated early.||||||
1250571|NCT00508118|Primary|Duration From Initiation of Cardiopulmonary Bypass (CPB) to Electrocerebral Silence (ECS), Defined as no Discernable Electroencephalographic Activity at an Amplification of 2 Micro Volts (μV)/mm, Confirmed for 3 Minutes||Day of surgery|3 SUBJECTS PER PROTOCOL.|||Time (minutes)||95% Confidence Interval|Median
1250572|NCT00508027|Primary|Change in Serum Creatinine Levels|Change in serum creatinine (Cr) levels after treatment with simvastatin|Baseline, 21 days||||mg/dL||Standard Deviation|Mean
1250573|NCT00508027|Primary|Change in Serum Alanine Transaminase (ALT) Levels|Change in serum alanine transaminase (ALT) after treatment with simvastatin|Baseline, 21 days||||U/L||Standard Deviation|Mean
1250582|NCT00508027|Other Pre-specified|Change in Plasma NOx Levels|Measurements of the levels of plasma nitric oxide metabolites (NOx), high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), tissue factor (TF) and vascular endothelial growth factor (VEGF)were performed before and after simvastatin treatment. Changes in mean plasma biomarker levels were assessed for each dose level; however, dose level 3 results were not analyzed, as only 2 subjects were enrolled in this dose group.|Baseline, 21 days|All participants for whom plasma biomarker levels were recorded at baseline and 21 days|||micromolar||Standard Deviation|Mean
1250583|NCT00508001|Secondary|Overall Survival|Overall survival defined as the time from randomization (start of treatment) until death from any cause.|assessed up to 360 days|The analysis performed in the intent-To-Treat population.|||Days||95% Confidence Interval|Median
1250584|NCT00508001|Secondary|Progression-free Survival|Progression-free survival defined as the period from date of randomization(start of treatment) to date of disease progression or death.|from the date of randomisation to the date of documented disease progression or death for any cause|The analysis has been performed in the Intent-To-Treat (ITT) population.|||Days||95% Confidence Interval|Mean
1250585|NCT00508001|Secondary|Objective Response Rate|"Objective Response rate defined as percentage of patients with Complete Response [CR] or Partial Response [PR] based on Response Evaluation Criteria in Solid Tumours (RECIST).~Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions as assessed by Magnetic Resonance Imaging (MRI). Complete response (CR) must have disappearance of all target and non-target lesions as assessed by MRI."|After 16 weeks of treatment.|The analysis has been performed in the Intent-To-Treat (ITT) population.|||percentage of patients|||Number
1250586|NCT00508001|Primary|Tumour Stabilisation Rate|"Tumour stabilisation rate calculated as percentage of patients with best objective tumour response (Complete Response, Partial Response or Stable Disease) for >=16 weeks based on Response Evaluation Criteria in Solid Tumours (RECIST).~Complete Response - Disappearance of all target lesions; Partial Response - >=30% decrease in the sum of longest diameter of target lesions; Progressive Disease - >=20% increase in the sum of longest diameter of target lesions; Stable Disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|After 16 weeks of treatment.|The analysis has been performed in the Intent-To-Treat (ITT) population.|||percentage of patients|||Number
1250587|NCT00507819|Secondary|Change From Baseline in Mean Minute Ventilation (L/Min) at 6 Weeks|Minute ventilation measurements were taken at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks||||L/min||Standard Deviation|Mean
1250588|NCT00507819|Secondary|Change From Baseline in Mean Respiratory Rate (Breaths/Min) at 6 Weeks|Respiratory rate was measured at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks||||breaths/min||Standard Deviation|Mean
1250589|NCT00507819|Secondary|Change From Baseline in Mean Heart Rate (Bpm) at 6 Weeks|Heart rate was measured at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks||||bpm||Standard Deviation|Mean
1250590|NCT00507819|Primary|Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks|Oxygen consumption measurements were taken at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks||||mL/kg/min||Standard Deviation|Mean
1250591|NCT00507767|Primary|Number of Participants With Progression-free Survival at 12-weeks|Progression-free survival (PFS) is defined as stable disease or better. Participants who have received at least one dose of dasatinib and who die or leave the study before 12 weeks will be counted as having progressive disease.|At 12-weeks|Analysis per protocol.|||participants|||Number
1250592|NCT00507689|Secondary|Percentage of Participants With Normal ALT at Week 96|Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.|Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.|||percentage of participants|||Number
1250593|NCT00507689|Secondary|Percentage of Participants With Normal ALT at Week 72|Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.|Week 72|Participants in the Full Analysis Set with available data at Week 72 were analyzed.|||percentage of participants|||Number
1250594|NCT00507689|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96||Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.|||percentage of participants|||Number
1250595|NCT00507689|Secondary|Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72||Week 72|Participants in the Full Analysis Set with available data at Week 72 were analyzed.|||percentage of participants|||Number
1250596|NCT00507689|Secondary|Percentage of Participants With HBV Recurrence at Week 96|HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.|Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.|||percentage of participants|||Number
1250597|NCT00507689|Primary|Percentage of Participants With HBV Recurrence Prior to or at Week 72|HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.|Pretreatment baseline through Week 72|Full Analysis Set|||percentage of participants|||Number
1250599|NCT00507559|Secondary|Effectiveness: Type I Endoleak and Type III Endoleak|Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure|12 months|Denominator is the number of subjects with adequate CT imaging available at 12 months|||participants|||Number
1250600|NCT00507559|Secondary|Effectiveness: Prosthesis Migration|Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure|12 months|The denominator is the number of subjects with adequate CT imaging available at 12 months|||participants|||Number
1250601|NCT00507559|Secondary|Effectiveness: EndoStaple Stent/Fracture|Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure|12 months|Denominator is number of subjects with adequate x-ray imaging available at 12 months|||participants|||Number
1250602|NCT00507559|Secondary|Effectiveness: Aneurysm Change|Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure|12 months|Denominator is number of subjects with assessable imaging. Films are not assessable for aneurysm change if the 30-day scan is not available as a baseline.|||participants|||Number
1250603|NCT00507559|Secondary|Effectiveness: Aneurysm Rupture|Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure|12 months|143 reflects the number of subjects with data for the 12 month visit.|||participants|||Number
1250604|NCT00507559|Secondary|Effectiveness: Surgical Conversion|"Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure.~Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device."|12 months|143 reflects the number of subjects with data for the 12 month visit.|||participants|||Number
1250605|NCT00507559|Secondary|Safety: SAE (Serious Adverse Event)|Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure|5 years||||participants|||Number
1250606|NCT00507559|Primary|Safety: MAE (Major Adverse Event)|Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group|30 days||||participants|||Number
1250607|NCT00507559|Primary|Effectiveness: Composite Success Rate|Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.|12 months||||participants|||Number
1250608|NCT00507546|Secondary|Change in Subjective Morning Alertness|Measured as the median of the average morning alertness (measured from 1-7 on the Stanford Sleepiness Scale, a Likert-like scale in which higher values are lower alertness) of the three weeks of either placebo or ramelteon treatment|10 weeks||||units on a scale||Full Range|Median
1250609|NCT00507546|Primary|Amount of Wakefulness After Sleep Onset (WASO)|Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment|10 weeks|All participants who completed the entire protocol.|||Minutes||Full Range|Median
1250610|NCT00507507|Secondary|Occurrence of HBV Resistance Mutations|The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192).|Baseline to Week 192|Genotyping was attempted for all participants with HBV DNA ≥ 400 copies/mL at Week 48, 96, 144, 192 and/or the early discontinuation visit, and for all participants (with HBV DNA ≥ 400 copies/mL) after Week 192 who were on study for at least 216 weeks when the last participant reached Week 192.|||participants|||Number
1250611|NCT00507507|Secondary|Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192|The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Weeks 48, 96, 144, and 192|Full Analysis Set|||participants|||Number
1250612|NCT00507507|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192|The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Weeks 48, 96, 144, and 192|Full Analysis Set|||participants|||Number
1250613|NCT00507507|Secondary|Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192|"The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point."|Weeks 48, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.|||participants|||Number
1250614|NCT00507507|Secondary|Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192|"The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point."|Weeks 48, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.|||participants|||Number
1250615|NCT00507507|Secondary|Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192|Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, 144, and 192|Full Analysis Set|||participants|||Number
1250616|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 192|The change from baseline in HBV DNA at Week 192 was analyzed.|Baseline to Week 192|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
1250617|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 144|The change from baseline in HBV DNA at Week 144 was analyzed.|Baseline to Week 144|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
1250618|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 96|The change from baseline in HBV DNA at Week 96 was analyzed.|Baseline to Week 96|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
1250620|NCT00507507|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192|The percentage of participants with HBV DNA < 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1250621|NCT00507507|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144|The percentage of participants with HBV DNA < 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, and 144|Full Analysis Set|||percentage of participants|||Number
1250622|NCT00507507|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192|The percentage of participants with HBV DNA < 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Week 192|Full Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1250623|NCT00507455|Secondary|Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score|"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||units on a scale||Standard Error|Least Squares Mean
1250624|NCT00507455|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score|"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||units on a scale||Standard Error|Least Squares Mean
1250625|NCT00507455|Secondary|Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score|"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||units on a scale||Standard Error|Least Squares Mean
1250626|NCT00507455|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score|"Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||units on a scale||Standard Error|Least Squares Mean
1250627|NCT00507455|Secondary|Change From Baseline in Volume Voided Per Micturition|"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||mL||Standard Error|Least Squares Mean
1250628|NCT00507455|Secondary|Change From Baseline in Number of Incontinence Episodes Per 24 Hours|"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population who had 3-day averaged incontinence episodes >0 at Baseline and with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||incontinence episodes||Standard Error|Least Squares Mean
1250629|NCT00507455|Secondary|Change From Baseline in Number of Urgency Episodes Per 24 Hours|"For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher.~The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||urgency episodes||Standard Error|Least Squares Mean
1250663|NCT00507208|Primary|Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors|Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as > 5mm improvement from the baseline measurement.|12 months||||participants|||Number
1250630|NCT00507455|Secondary|Change From Baseline in Number of Micturitions Per 24 Hours|"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||micturitions||Standard Error|Least Squares Mean
1250631|NCT00507455|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|"The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||units on a scale||Standard Error|Least Squares Mean
1250632|NCT00507455|Secondary|Change From Baseline in IPSS Storage Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||units on a scale||Standard Error|Least Squares Mean
1250633|NCT00507455|Secondary|Change From Baseline in IPSS Voiding Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||units on a scale||Standard Error|Least Squares Mean
1250634|NCT00507455|Secondary|Change From Baseline in International Prostate Symptoms Score (IPSS)|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms:~Sensation of incomplete emptying~Repeat urinating after 2 hours (frequency)~Start and stop several times (intermittency)~Urgency~Weak stream~Straining~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||units on a scale||Standard Error|Least Squares Mean
1250635|NCT00507455|Secondary|Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests|Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug.|From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).|Safety analysis set population consisted of participants who received at least 1 dose of double-blind treatment.|||participants|||Number
1250636|NCT00507455|Secondary|Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)|"Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency.~LS means were adjusted for pooled center and Baseline value."|Baseline and Week 12|Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.|||Percent voiding efficiency||Standard Error|Least Squares Mean
1250637|NCT00507455|Secondary|Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)|"The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~LS means were adjusted for pooled center and Baseline value."|Baseline and Week 12|Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1250638|NCT00507455|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.|Baseline and Week 12|Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had urodynamic measurements at baseline and post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.|||mL/sec||Standard Error|Least Squares Mean
1250684|NCT00506831|Secondary|Change in Digital Ulcerations at 6 Months Compared to Baseline|Number of digital ulcers as measured by physician assessment at 6 months compared to baseline|6 months compared to baseline|No data were collected for this outcome measure||||||
1250639|NCT00507455|Secondary|Change From Baseline in Post Void Residual Volume (PVR)|"Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~End-of-treatment is the last post-baseline assessment during the treatment period.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set (FAS) population with available data at each time point (as indicated by N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||mL||Standard Error|Least Squares Mean
1250640|NCT00507455|Primary|Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)|Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.|Baseline and Week 12|Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had both urodynamic measurements at baseline and one or both measured at any post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.|||cmH2O||Standard Error|Least Squares Mean
1250641|NCT00507442|Secondary|Overall Survival|Overall survival is defined as time from the date of randomization to the date of death|Up to 48 weeks or until death|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.|||days||95% Confidence Interval|Median
1250642|NCT00507442|Secondary|Probability of 1-year Survival||survival probability at 1 year after randomization|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.|||percentage of patients|||Number
1250643|NCT00507442|Secondary|Progression-free Survival|"Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression/death|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.|||days||95% Confidence Interval|Median
1250644|NCT00507442|Secondary|Time to Response|Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments.|Up to 48 weeks or until disease response|Responders (patients achieved complete and partial response) in the response evaluable population.|||days||Full Range|Median
1250645|NCT00507442|Secondary|Time to Disease Progression|"Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.|||days||95% Confidence Interval|Median
1250646|NCT00507442|Secondary|Duration of Response|"Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression|Responders (patients achieved complete and partial response) in the response evaluable population.|||days||95% Confidence Interval|Median
1250647|NCT00507442|Secondary|Number of Patients With Complete Response Rate + Near Complete Response Rate|"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow."|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.|||participants|||Number
1250648|NCT00507442|Secondary|Number of Patients With Stringent Complete Response Rate|Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.|||participants|||Number
1250649|NCT00507442|Secondary|Number of Patients With Overall Response|"Overall Response includes complete response and partial response.~Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to < 200 mg per 24 hour."|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.|||participants|||Number
1250650|NCT00507442|Secondary|Number of Patients With Adverse Events (AEs)|Evaluate the safety and tolerability of the combination therapy|From first dose of study drug through the 30 day post-treatment AE assessment visit|The safety population includes patients received any dose of any study drug.|||participants|||Number
1250664|NCT00507130|Secondary|Terminal Phase Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis|||Day||Standard Deviation|Mean
1250651|NCT00507442|Primary|Number of Patients With Combined Complete Response and Very Good Partial Response|"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h"|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.|||participants|||Number
1250652|NCT00507429|Secondary|To Determine Percentage of 1 Year Survival||from randomization through end of study visit|Intent to treat|||percentage of participants|||Number
1250653|NCT00507429|Secondary|To Determine Progression Free Survival||from randomization through end of study visit|||||||
1250654|NCT00507429|Primary|Overall Survival||From randomization to date last known alive|All randomized subjects (the Intent-to-treat population) included in the analysis|||months||95% Confidence Interval|Median
1250655|NCT00507416|Secondary|Change From Baseline in EORTC QLQ-C30 - Global Health Status|"The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement."|Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13|"Intent-to-treat population with available data at each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1250656|NCT00507416|Secondary|Time to Alternative Therapy|Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact.|From randomization until alternative therapy. Median follow-up time was 43 months.|Intent to Treat|||months||95% Confidence Interval|Median
1250657|NCT00507416|Secondary|Overall Survival|Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.|From randomization until death. Median follow-up time was 43 months.|Intent to treat|||months||95% Confidence Interval|Median
1250658|NCT00507416|Secondary|Duration of Response|Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response.|From first documented response until disease progression. Median follow-up time was 43 months.|Participants with an overall response|||months||95% Confidence Interval|Median
1250659|NCT00507416|Secondary|Percentage of Participants With a Complete Response or a Very Good Partial Response|"Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.~Response was assessed by the Investigator using the IMWG uniform response criteria."|Response assessed every other cycle for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.|||percentage of participants|||Number
1250660|NCT00507416|Secondary|Percentage of Participants With a Complete Response|Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria.|Response assessed every other cycle, for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.|||percentage of participants|||Number
1250661|NCT00507416|Secondary|Percentage of Participants With an Overall Response|"Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.~CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).~PR requires 1 of the following:~≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or~If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or~If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.~If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required."|Response assessed every other cycle for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.|||percentage of participants|||Number
1250662|NCT00507416|Primary|Progression Free Survival (PFS)|"PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease"|From randomization until disease progression. Median follow-up time was 43 months.|Intent-to-treat (all randomized participants)|||months||95% Confidence Interval|Median
1250666|NCT00507130|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis|||Day||Standard Deviation|Mean
1250667|NCT00507130|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 84, 119, and 150|All subjects who received at least one dose of MEDI-528|||Participants|||Number
1250668|NCT00507130|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
1250669|NCT00507130|Primary|Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results|Number of participants experiencing abnormal clinically significant MRI results|Days -14 to -1 and 28|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
1250670|NCT00507130|Primary|Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results|Number of participants with abnormal clinically significant ECG results|Days -14 to -1, 14, 28, 56, 84, and 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
1250671|NCT00507130|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal|Days 0, 14, 28, 56, 84, and 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
1250672|NCT00507130|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
1250673|NCT00506948|Primary|Number of Participants With Acute Graft-versus-host Disease (aGVHD)|Participants who had acute graft-versus-host disease (aGVHD) within 100 days post transplant. Physical exam and bloodwork every week (for the first 90-100 days after the transplant).|Baseline to 100 days post transplant||||participants|||Number
1250674|NCT00506948|Primary|Failure Rate|Efficacy failure defined as a participants who had either grade 3-4 acute graft-versus-host disease (aGVHD) or treatment related mortality (TRM) within 100 days post transplant. Failure Rate calculated as (# of failures) / (# participants evaluated). Physical exam and bloodwork every week (for the first 90-100 days after the transplant).|Baseline to 100 days post transplant|||||||
1250675|NCT00506922|Primary|Number of Patients Without GVHD at 100 Days|The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.|100 days|All analysis was intention to treat (ITT).|||participants|||Number
1250676|NCT00506883|Primary|Responders|Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.|24 hours after baseline|The Intent-to-Treat (ITT) population(N=184) was used. The ITT group is defined as all patients who were randomized,and had a qualifying gout flare based on contact with the Gout Flare Call Center, who were instructed to begin taking and took at least one dose of the study drug study drug. One patient had a flare, but|||Participants|||Number
1250677|NCT00506857|Secondary|Number of Participants With Graft Versus Host Disease (GVHD)|Tacrolimus and Methotrexate used for acute graft versus host disease (aGVHD) prophylaxis, clinical grading AGVHD criteria (Days 1-100): Grade 1: + to ++ skin rash; no gut involvement; no decrease in clinical performance status; Grade 2: + to +++ skin rash; + gut involvement and/or + liver involvement; mild decrease in performance status; Grade 3: ++ to +++ skin rash; ++ to +++ gut involvement and/or ++ to ++++ liver involvement; marked decrease in performance status; Grade 4: Similar to Grade 3 with ++ to ++++ organ involvement and extreme decrease in performance status.|5 years|Analysis was per protocol for 73 patients out of 80 patients due to 3 early deaths and 4 non engraftments.|||Participants|||Number
1250678|NCT00506857|Primary|Maximum Tolerated Dose (MTD)|"Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where toxicity is defined as grade 3 or 4 conventional toxicity [National Cancer Institute Common Toxicity Criteria (NCI-CTC)]. Participant evaluation in a cohort with each modality is 30 days."|1 month|Analysis was per protocol.|||mg/kg|||Number
1250679|NCT00506831|Secondary|Change in Serum Autoantibody Profile at 6 Months Compared to Baseline||6 months compared to baseline|No data were collected for this outcome measure||||||
1250680|NCT00506831|Secondary|Cell Types That Contribute to the Gene Expression Changes Associated With Imatinib Therapy|To determine which cell types may be contributing to the gene expression changes associated with imatinib therapy, imatinib-responsive genes were isolated from from patient biopsies. From the total number of imatinib-responsive genes that were isolated, the percentage that came from endothelial cells, fibroblasts, B-cells, and multiple cell types was calculated. Reported values do not total to 100% because of rounding.|6 months compared to baseline|Participants with available data were included in the analysis|||percentage of isolated genes|Isolated imantinib-responsive genes||Number
1250681|NCT00506831|Secondary|Change in Serum Cytokine Profile at 6 Months Compared to Baseline||6 months compared to baseline|No data were collected for this outcome measure||||||
1250682|NCT00506831|Secondary|Change in Dermal Thickness and Collagen Separation on Cutaneous Histopathology at 6 Months Compared to Baseline||6 months compared to baseline|Participants with available data were included in the analysis|||mm|||Number
1250683|NCT00506831|Secondary|Change in Scleroderma Health Assessment Questionnaire at 6 Months Compared to Baseline|Change in Health Assessment Questionnaire disability index at 6 months compared to baseline. The Questionnaire is comprised of a 20 question instrument pertaining to specific activities with possible integer responses of 0 (without any difficulty) to 3 (unable to do), and five additional scleroderma-specific visual analog scale (VAS) domains with possible values ranging from 0.0 to 15.0. The 20 questions are divided into eight domains. A mean score is calculated for each domain ranging from 0 to 3. A composite score is calculated by dividing the summed domain scores by the number of domains answered. The composite score is reported, falling between 0 and 3 on an ordinal scale. The scores are interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|6 months compared to baseline|Participants with available data were included in the analysis|||units on a scale||Full Range|Mean
1250685|NCT00506831|Secondary|Change in Pulmonary Function Tests at 6 Months Compared to Baseline|Change in % predicted Forced Vital Capacity (FVC) at 6 months compared to baseline. FVC is the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.|6 months compared to baseline|Participants with available data were included in the analysis|||FVC% predicted||Full Range|Mean
1250686|NCT00506831|Primary|Percent Change in Modified Rodnan Skin Score at 6 Months Compared to Baseline|Modified Rodnan skin score (mRSS) on scale of 0 (no skin disease) to 51 severe skin disease. %change in mRSS=(score at 6 months - baseline score)/baseline score. Negative values indicate improvement in skin disease. Clinical important improvement defined as > 25% improvement.|6 months compared to baseline|Participants who completed the protocol were included in the analysis|||percentage of change in MRSS||Standard Deviation|Mean
1250687|NCT00506714|Secondary|Gait Velocity|Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use|4 weeks|Analysis was per protocol|||cm/s||Standard Deviation|Mean
1250688|NCT00506714|Secondary|Gait Velocity With a Cane in Hip OA Subjects|Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.|Baseline|Analysis was per protocol|||cm/s||Standard Deviation|Mean
1250689|NCT00506714|Primary|Gait Velocity||Baseline|Analysis was per protocol|||cm/s||Standard Deviation|Mean
1250690|NCT00506675|Primary|Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam|Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.|baseline to 10 Weeks||||logMAR||Standard Deviation|Mean
1250691|NCT00506675|Primary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks|Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.|baseline to 10 Weeks||||Participants|||Number
1250692|NCT00506675|Primary|Mean (SD) Distribution of Visual Acuity at 10 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|10 Weeks||||logMAR||Standard Deviation|Mean
1250693|NCT00506675|Primary|Distribution of Amblyopic Eye Visual Acuity at 10 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|10 Weeks||||participants|||Number
1250694|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Months 5-7|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, months 5-7|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.|||episodes per week by visit||Standard Deviation|Mean
1250695|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Months 2-4|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, months 2-4|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.|||episodes per week by visit||Standard Deviation|Mean
1250696|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Month 1|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, month 1|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.|||episodes per week by visit||Standard Deviation|Mean
1250697|NCT00506662|Secondary|Change in Body Weight at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1250698|NCT00506662|Secondary|Change in Body Weight at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1250699|NCT00506662|Secondary|Change in Mean Pre-dinner Plasma Glucose at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1250700|NCT00506662|Secondary|Change in Mean Pre-dinner Plasma Glucose at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1250701|NCT00506662|Secondary|Change in Mean Pre-lunch Plasma Glucose at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1250702|NCT00506662|Secondary|Change in Mean Pre-lunch Plasma Glucose at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1250703|NCT00506662|Secondary|Change in Mean Fasting Plasma Glucose (FPG) at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1250704|NCT00506662|Secondary|Change in Mean Fasting Plasma Glucose (FPG) at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
1250707|NCT00506597|Primary|Number of Participants Treated With Erwinase as a Replacement for E.Coli L-asparaginase or Pegylated E.Coli L-asparaginase as Part of the Treatment for Acute Lymphoblastic Leukemia (ALL) or T or B Cell Lymphoma|Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.|4 years||||participants|||Number
1250708|NCT00506597|Primary|Participant Toxicity Data|Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.|3 Years|||||||
1250709|NCT00506493|Secondary|Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure|Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|9 months||||percentage of subjects|||Number
1250710|NCT00506493|Secondary|Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 9 Months||9 months||||percentage of subjects|||Number
1250711|NCT00506493|Primary|Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|30 days post procedure or hospital discharge||||percentage of subjects|||Number
1250712|NCT00506493|Primary|Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months|Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours|9 months|75 subjects were enrolled, 14 subjects had no Holter assessment performed- 6 subjects died, 5 subjects withdrew participation, and 3 subjects completed endpoint follow-up without analyzable Holter data.|||percentage of subjects|||Number
1250713|NCT00506454|Primary|Reduction in Endotoxin Levels.|The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.|Baseline and at 4 weeks||||Participants|||Number
1250714|NCT00506441|Secondary|Incidence of Adverse Events||12 weeks (Week 0-12) and 4 weeks (Week 12-16)|||||||
1250715|NCT00506441|Secondary|Change From Baseline in Triglyceride||12 weeks|||||||
1250716|NCT00506441|Secondary|Change From Baseline in VLDL Cholesterol||12 weeks|||||||
1250717|NCT00506441|Secondary|Change From Baseline in HDL Cholesterol||12 weeks|||||||
1250718|NCT00506441|Secondary|Change From Baseline in LDL Cholesterol||12 weeks|||||||
1250719|NCT00506441|Secondary|Change From Baseline in Total Cholesterol||12 weeks|||||||
1250720|NCT00506441|Secondary|Change From Baseline in Calcium x Phosphorus Ion Product||12 weeks|||||||
1250721|NCT00506441|Secondary|Change From Baseline in Calcium||12 weeks|||||||
1250722|NCT00506441|Secondary|Change From Baseline in PTH||12 weeks|||||||
1250723|NCT00506441|Secondary|Change From Baseline in Serum Phosphorus||12 weeks (Week 0 to Week 12)|ITT1 (The ITT1 population included all enrolled subjects who have taken at least one dose of study medication and have at least one central phosphorus value after the start of study medication.)|||mg/dL||95% Confidence Interval|Mean
1250724|NCT00506441|Primary|The Change in Serum Phosphorus From Week 12 to Week 16|The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)|4 weeks (Week 12 to Week 16)|Intent-to-treat (ITT) 2 (The ITT2 population included all subjects who complete 12-weeks, receive a randomization number and receive at least one dose of study medication in the placebo-controlled withdrawal phase, either MCI-196 or placebo, and have at least one central phosphorus value after 12-weeks.)|||mg / dL||Standard Deviation|Mean
1250725|NCT00506415|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events||30 days after a maximum of 96 weeks treatment|The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.|||Participants|||Number
1250726|NCT00506415|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period|Change from baseline to week 48 as assessed by the Neuropsychiatric Inventory (NPI)-10 total score. The scale consists of 10 domains that are rated for both frequency (range 1-4) and severity (range 1-3). A composite score for each domain is calculated (frequency x severity) which ranges from 1 to 12. There is a leading question for each item. If the symptom is not present then the frequency, severity and distress scores are not completed. In this case the score is 0 for the item. The sum of the composite scores yields the NPI-10 total score (range 0-120). A negative change in score indicates an improvement from baseline (symptom reduction).|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients with an assessment at baseline and week 48, who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog, ADCS-IADL).|||units on a scale||Standard Deviation|Mean
1250727|NCT00506415|Secondary|Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period|Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part B. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. TMT has two parts: Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-Part B except the person must alternate between numbers and letters. Total values for TMT part B range between 0 and 420 seconds. A negative change from baseline indicates an improvement in condition.|Baseline and week 48 of double blind period|Intent to treat population (ITT-DB): included all randomized patients with an assessment at baseline and week 48 who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog, ADCS-IADL).|||Time in seconds||Standard Deviation|Mean
1250728|NCT00506415|Secondary|Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period|Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part A. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. The score represents the amount of time required to complete the task. Total values for TMT part A range between 0 and 300 seconds. A negative change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population (ITT-DB): included all randomized patients with an assessment at baseline and week 48 who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog and ADCS-IADL).|||Time in seconds||Standard Deviation|Mean
1250729|NCT00506415|Secondary|Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period|Functional decline was defined by either an at least 1 point decrease in the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) subscale score in a visit and confirmed by the following visit/assessment or at least 2 points decrease from the double blind randomization baseline.|390 days was the maximum|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.|||Time in days||95% Confidence Interval|Median
1250730|NCT00506415|Primary|Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period|The Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) is a 16 item subscale of the caregiver-based ADCS-IADL scale, developed for the use in dementia studies. The ADCS-IADL total score ranges from 0 to 56, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.|||units on a scale||Standard Deviation|Mean
1250731|NCT00506415|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period|The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.|||units on a scale||Standard Deviation|Mean
1250732|NCT00506389|Secondary|Average Subjective Total Sleep Time (TST) During the In-Treatment Period|TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.|From Day 1 to Day 36|The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.|||Minutes||Standard Deviation|Mean
1250733|NCT00506389|Secondary|Average Latency to Persistent Sleep (LPS) During the In-Treatment Period|LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.|From Day 1 to Day 36|The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.|||Minutes||Standard Deviation|Mean
1250734|NCT00506389|Primary|Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period|WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.|From Day 1 to Day 36|The Intent-to-Treat (ITT) group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.|||Minutes||Standard Deviation|Mean
1250735|NCT00506350|Secondary|Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed were H5N1 A/Indonesia and H5N1 A/Vietnam.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||T-cell/million cells||Inter-Quartile Range|Median
1250736|NCT00506350|Secondary|Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed wwere H5N1 A/Indonesia and H5N1 A/Vietnam.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||T-cells/million cells||Inter-Quartile Range|Median
1250737|NCT00506350|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection. The flu strain assessed was A/Indonesia/05/2005 (H5N1).|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Participants|||Count of Participants
1250738|NCT00506350|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|"Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection.~The flu strain assessed was A/Indonesia/05/2005 (H5N1)."|At Days 0, 7, 14, 21, 28, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1250739|NCT00506350|Secondary|Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Fold increase||95% Confidence Interval|Geometric Mean
1250740|NCT00506350|Secondary|Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.|At Days 7, 14, 21, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1250741|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for neutralizing antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Participants|||Count of Participants
1250742|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for anti-HA antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.|At Days 21 (post-vaccination one) and 42 (post-vaccination two)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1250743|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Participants|||Count of Participants
1250744|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Days 7,14, 21, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1250745|NCT00506350|Secondary|Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Titers||95% Confidence Interval|Geometric Mean
1250746|NCT00506350|Secondary|Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Days 0, 7, 14, 21, 28, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, whiich included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1250747|NCT00506350|Secondary|Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which included all subjects who had serologic results available at the antibody persistence time-point.|||Titers||95% Confidence Interval|Geometric Mean
1250748|NCT00506350|Secondary|Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005. No subject from GSK1562902A AD F1 Primed Group has received a second vaccination.|At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1250749|NCT00506350|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 up to Month 24)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1250750|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1250751|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1250752|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
1250753|NCT00506350|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
1250754|NCT00506350|Primary|Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1250755|NCT00506350|Primary|Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1250756|NCT00506350|Primary|Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1250757|NCT00506350|Primary|Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for HI antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1250758|NCT00506350|Primary|Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1250759|NCT00506350|Primary|Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1250760|NCT00506285|Secondary|Conners' Adult ADHD Rating Scales (CAARS)|Measures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms.|Double-blind endpoints for MTS and placebo arms||||units on a scale||Standard Deviation|Mean
1250761|NCT00506285|Primary|Wender Reimherr Adult Attention Deficit Disorder Scale|This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.|Double-blind endpoints during MTS and placebo arms|"All subjects given active treatment last observation carried forward using a mixed models design."|||units on a scale||Standard Deviation|Mean
1250762|NCT00506155|Secondary|5-year Overall Survival (OS)|The overall survival rate stated as a five-year survival rate, which is the percentage of participants in study who are alive five years after the start of treatment.|5 years||||Percentage of Participants|||Number
1250763|NCT00506155|Primary|Percentage of Participants With Response Defined as the Absence of Residual Muscle Invasive Cancer in Resected Specimen|"Number of participants out of total with a response defined as “downstaging” to <= pT1N0 in the resected specimen. A binary variable was defined for downstaging (pathologic stage below initial clinical stage and below pT1N1N0M0); staging using American Joint Committee on Cancer (AJCC) TNM system of TNM; T describes size tumor & cancer spread into nearby tissue; N describes spread to nearby lymph nodes; & M describes metastasis (spread to other parts of body). Numbers after T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures, higher the T number, the larger the tumor and/or more it has grown into nearby tissues. Responses of lesser magnitude scored as treatment failure. Response Evaluation Criteria In Solid Tumors (RECIST) criteria do not apply for this cohort of neoadjuvant participants since this study does not require measurable disease by traditional assessment."|Following 20 weeks of chemotherapy|All 60 participants completed at least 1 cycle of chemotherapy.|||Percentage of Participants|||Number
1250764|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Working Memory Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||Standard Error|Least Squares Mean
1250765|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Episodic Memory Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||Standard Error|Least Squares Mean
1250766|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Attention/Processing Speed Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||Standard Error|Least Squares Mean
1250767|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||Standard Error|Least Squares Mean
1250768|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score|The Working Memory Composite Score was comprised of the University of Pennsylvania’s Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||95% Confidence Interval|Least Squares Mean
1250769|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score|The Episodic Memory Composite Score was comprised of the University of Pennsylvania’s Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||95% Confidence Interval|Least Squares Mean
1250770|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score|The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||95% Confidence Interval|Least Squares Mean
1250771|NCT00506077|Primary|Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.|The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||95% Confidence Interval|Least Squares Mean
1250772|NCT00506064|Primary|Objective Sleep Response of Patients|Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)|Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative|Since unable to accrue an adequate number of cases with data, unable to provide analysis.||||||
1250773|NCT00506025|Primary|Antimicrobial Activity of Urine From Pregnant Subjects Following Cranberry Juice Cocktail (CJC)|The primary outcome measure was the measurement of bacteriuria in study subject urine, defined as having a urine culture with 100,000 or more of a single uropathogen (measured as cfu per ml).|7 months, from enrollment at 3 months of pregnancy to delivery|a priori for a pilot study|||cfu per ml||Full Range|Median
1250774|NCT00505934|Secondary|Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.|||Consecutive doses||Standard Deviation|Mean
1250775|NCT00505934|Secondary|Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.|||Subjects|||Number
1250776|NCT00505934|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.|||Subjects|||Number
1250777|NCT00505921|Primary|Participant Progression Free Survival at 2 Years|Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.|2 years|Analysis was per protocol. Nine participants were not eligible for treatment therefore were excluded from analysis.|||participants|||Number
1250778|NCT00505895|Secondary|Acute Grade II-IV Graft Versus Host Disease (GVHD)|Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4.|GVHD grading weekly during first 100 days; Annual examinations for nine year study period|For the acute GVHD analysis, only 48 patients’ data were available.|||percentage of participants|||Number
1250779|NCT00505895|Primary|Number of Participants With Successful Engraftment at Day 100||Day 100||||participants|||Number
1250780|NCT00505778|Secondary|Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6|Is your ulcerative colitis in remission (not active)? Y/N|6 months|ITT Population|||Percentage of Participants|||Number
1250781|NCT00505778|Secondary|Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6|MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.|6 months|ITT Population|||MARS Score||Standard Error|Mean
1250782|NCT00505778|Secondary|Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population|Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|6 months|ITT Population|||Participants|||Number
1250783|NCT00505778|Secondary|Percentage of Patients Remaining in Remission at Month 12, ITT Population|Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|12 months|ITT Population|||Percentage of Participants|||Number
1250784|NCT00505778|Secondary|Percentage of Patients Remaining in Remission at Month 3, ITT Population|Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|3 months|ITT Population|||Percentage of Participants|||Number
1250785|NCT00505778|Primary|Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)|Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|6 months|ITT Population|||Percentage of Participants|||Number
1250786|NCT00505765|Secondary|Change in SCoRS Interviewer Global Rating|Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity by completing a 20-question rating scale via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. After the interview, the interviewer rated subject's overall difficulty on a Global Scale of 1-10. Higher scores indicate greater cognitive impairment.|Baseline, 12 weeks|Participants administered SCoRS at both Baseline and 12 weeks were included in analysis|||units on a scale||Standard Deviation|Mean
1250787|NCT00505765|Secondary|Change in SCoRS Interviewer Global Rating|Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity by completing a 20-question rating scale via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. After the interview, the interviewer rated subject's overall difficulty on a Global Scale of 1-10. Higher scores indicate greater cognitive impairment.|Baseline, 6 weeks|Participants administered SCoRS at both Baseline and 6 weeks were included in analysis|||units on a scale||Standard Deviation|Mean
1250788|NCT00505765|Secondary|Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores|UPSA includes 5 skill areas (subscales) with scores that each range from 0-20. The UPSA yields an overall total score which is the sum of the five subscales and ranges from 0-100. Higher scores are associated with more independent living.|Baseline, 12 weeks|Only participants with UPSA scores at both Baseline and 12 weeks were included in this analysis|||units on a scale||Standard Deviation|Mean
1250789|NCT00505765|Secondary|Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores|UPSA includes 5 skill areas (subscales) with scores that each range from 0-20. The UPSA yields an overall total score which is the sum of the five subscales and ranges from 0-100. Higher scores are associated with more independent living.|Baseline, week 6|Only participants with UPSA scores at both Baseline and 6 weeks were included in this analysis|||units on a scale||Standard Deviation|Mean
1250790|NCT00505765|Primary|Change in MATRICS Consensus Cognitive Battery (MCCB)|The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Baseline, 12 weeks|Only participants with completed MCCB at both Baseline and 12 weeks were included in analysis|||units on a scale||Standard Deviation|Mean
1250791|NCT00505765|Primary|Change in MATRICS Consensus Cognitive Battery Composite Score Change|The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Baseline, week 6|Only participants with completed MCCB at both baseline and 6 weeks were included in analysis|||units on a scale||Standard Deviation|Mean
1250792|NCT00505752|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])|ITT population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Percentage of participants|||Number
1250793|NCT00505752|Primary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])|Intention-to-treat (ITT) population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||2PN oocytes||Standard Deviation|Mean
1250794|NCT00505687|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.|||Score on a scale||Standard Deviation|Mean
1250795|NCT00505687|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|four years|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
1250796|NCT00505687|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|four years|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
1250797|NCT00505661|Primary|Objective Response Rate Following Treatment With Letrozole|Using RECIST criteria, Objective Response evaluated every 2 months.|2 month intervals for first 2 years|Analysis was per protocol, only 9 of 12 eligible patients were evaluable for response.|||participants|||Number
1250798|NCT00505635|Secondary|Number of Participants With Response|Response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).|Following each 21 day cycles|||||||
1250799|NCT00505635|Primary|Time to Progression (TTP)|TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Following two 21 day cycles until disease progression||||days||Full Range|Geometric Mean
1250800|NCT00505622|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.|Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up|Safety population|||Hours||Standard Deviation|Mean
1250801|NCT00505622|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline, Week 0, Week 20, Week 32|Safety population|||Scores on a scale||Standard Deviation|Mean
1250802|NCT00505622|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week 20, Week 32|Safety Population|||Scores on a scale||Standard Deviation|Mean
1250803|NCT00505622|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.|Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up|Safety Population - All subjects entering the open-label extension study who took at least 1 dose of perampanel.|||Hours||Standard Deviation|Mean
1250804|NCT00505518|Primary|Nurse Telepsychiatry Services Satisfaction Questionnaire|The charge nurse’s satisfaction with the telepsychiatry services were surveyed using a satisfaction questionnaire specifically designed for this study. The satisfaction questionnaire is a scale with three choices: “not satisfied”, “satisfied”, and “highly satisfied.”|30 days or 60 days (length depended on clinical needs of patients)||||Participants|||Number
1250805|NCT00505518|Primary|Patient/Family Telepsychiatry Service Satisfaction Survey|Patients’ (or their family members’ for those who had severe cognitive deficits) satisfaction with the telepsychiatry services were surveyed using a satisfaction questionnaire specifically designed for this study. The satisfaction questionnaire is a scale with three choices: “not satisfied”, “satisfied”, and “highly satisfied.”|30 days or 60 days (length depended on clinical needs of patients)||||participants|||Number
1250806|NCT00505518|Primary|Change in Mean Scores on Clinical Global Impressions|Minimum score - 1 (better outcome) Maximum score - 7 (worse outcome)|Baseline, 30 days or 60 days (length depended on clinical needs of patients)||||units on a scale||Standard Deviation|Mean
1250807|NCT00505414|Secondary|Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change (PGIC) is an instrument where the participant indicates their perceived change at the end of a treatment phase. The overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in tapentadol and morphine at Day 15 (Start of Maintenance Phase) and repeated in participants completing the Maintenance Phase in the Matching Placebo, Tapentadol and Morphine (Day 43).|Day 15 corresponds with PGIC at end of titration phase; Day 43 corresponds with PGIC at end of maintenance phase|Full Analysis Set. Number of participants with data available.|||participants|||Number
1250808|NCT00505414|Primary|Responder Rates in Maintenance Period|"A responder is a participant in the study that:~completed 28 days of the maintenance phase~had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.~did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43).~A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that fails to meet at least 1 of the 3 criteria is not counted as a responder."|End of the 4 week Maintenance Phase (Day 43)|Full Analysis Set. Number of participants with data available.|||participants|||Number
1250809|NCT00505375|Primary|Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|2 years of follow up||||nmol/L||95% Confidence Interval|Geometric Mean
1250810|NCT00505362|Secondary|Operative Times|Operative time of the cesarean delivery in minutes.|From start to the end of the cesarean delivery, assessed up to two hours.||||minutes||Standard Deviation|Mean
1250811|NCT00505362|Primary|Post-operative Pain|Post-operative pain was assessed using Silverman Integrated Assessment (SIA) pain score which combines the opioid use and movement pain score over the 72-hour study period. The SIA pain and opioid score is calculated by first rank ordering each patient’s total opioid use (morphine milligram equivalents) and area under the curve (AUC) movement pain score over the 72 hour study period, then calculating a mean for both opioid use and movement pain scores, expressing both opioid use and movement pain score as percent differences from the mean, and lastly adding the percent differences from the mean for the two variables. The SIA composite score value for each subject ranges from approximately 200% to approximately -200%, with the highest positive score indicating the least comfortable or the most pain despite the greatest use of analgesics, and the lowest score indicating the most comfortable or least pain despite the least use of analgesics.|72-hour study period||||Scores on a scale||Standard Deviation|Mean
1250812|NCT00505284|Secondary|Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period|If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication.|Baseline to Week 15|ITT Population|||Participants|||Number
1250813|NCT00505284|Secondary|Presence or Absence of Allodynia at Week 15/EOT|Investigators rated subjects’ allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed.|Week 15/EOT|ITT Population|||Participants|||Number
1250814|NCT00505284|Secondary|Withdrawal Due to Treatment Failure During Double-Blind Dosing Period|Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to ‘lack of therapeutic efficacy,’ the subject was counted as a withdrawal due to treatment failure.|Baseline and Week 15|ITT Population|||Participants|||Number
1250815|NCT00505284|Secondary|Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores|HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21.|Baseline and Week 15/EOT|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1250816|NCT00505284|Secondary|Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores|Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status.|Baseline and Week 15/EOT|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1250817|NCT00505284|Secondary|Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT|At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF.|Week 15/EOT|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.|||Participants|||Number
1250818|NCT00505284|Secondary|Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT|SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity.|Baseline and Week 15/EOT|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1250819|NCT00505284|Secondary|Change in Average Sleep Interference Scores From Baseline to Week 15/EOT|Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]). Based on modified BOCF.|Baseline to Week 15/EOT|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1250820|NCT00505284|Primary|Mean Change in Average Pain Scores From Baseline at Each Study Week|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.|Baseline, Week 1 to Week 17|ITT Population|||Scores on a Scale||Standard Deviation|Mean
1250821|NCT00505284|Primary|Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.|Baseline to Week 15/EOT|ITT Population. A responder was defined as a subject who had at least a 50% reduction in average pain scores from Baseline to Week 15/EOT.|||Percentage of Participants|||Number
1250822|NCT00505284|Primary|Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.|Baseline to Week 15/EOT|ITT Population. A responder was defined as a subject who had at least a 30% reduction in average pain scores from Baseline to Week 15/EOT.|||Percentage of Participants|||Number
1250823|NCT00505284|Primary|Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)|Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).|Baseline to Week 15/EOT|Intent-to-Treat (ITT) Population - Randomized subjects who took at least 1 dose of study drug and had at least 1 efficacy assessment at Baseline.|||Scores on a Scale||Standard Deviation|Mean
1250824|NCT00505076|Secondary|Schizophrenia Cognition Rating Scale (SCoRS) Score|The Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity. The SCoRS Interviewer Global Rating of function has a range 1 to 10. Higher ratings indicate greater impairment.|4 Weeks (Baseline to End of Treatment)|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.|||SCoRS Score||Standard Deviation|Mean
1250825|NCT00505076|Secondary|UPSA(UCSD Performance-Based Skills Assessment) Summary Score|The UCSD Performance-Based Skills Assessment assessed functional capacity. The UPSA Summary Score has a range from 0 to 120. A higher score indicates less impairment.|Baseline and end of treatment, a total of four weeks.|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.|||UPSA Summary Score||Standard Deviation|Mean
1250826|NCT00505076|Primary|Composite MATRICS Consensus Cognitive Battery Score|The primary outcome measure is the composite score on the Matrics Consensus Cognitive Battery (MCCB). The MCCB composite score is a standardized mean of the seven domain scores. T-scores are standardized to normative data, and have an estimated mean of 50 and SD of 10 in the general healthy population. Data reduction for analysis of neurocognitive testing used the following steps: i) individual neurocognitive test scores at baseline and follow-up were converted to t-scores; ii) t-scores within the pre-specified cognitive domains measured by more than one test were averaged to obtain a domain-specific t-score; and iii) domain-specific t-scores were averaged to create the MCCB composite score.|4 weeks|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.|||composite score||Standard Deviation|Mean
1250827|NCT00504985|Primary|Patient Fatigue Severity Scores Assessed With MDASI|"Descriptive factor and cluster analysis using MD Anderson Symptom Index (MDASI) 13 core symptom items to form 1) treatment-related factor (nausea and vomiting) and 2) general severity factor (the remaining 11 core symptom items). Patients rate intensity and interference of symptoms on 0–10 numeric scales from not present to as bad as you can imagine. Patients also rate the amount of interference with daily activities caused by symptoms on 0–10 numeric scales from did not interfere to interfered completely."|Survey and blood draw done within 24 hours of patient's Emergency Center visit|Study terminated early due to low recruitment, insufficient data for analysis.||||||
1250828|NCT00504894|Primary|New Encoding (Scanner) Task Reaction Time (ms)|The encoding task was performed in the scanner. Subjects viewed a pseudorandom sequence of 160 images, made up of the 40 negative–arousing targets and 40 neutral targets, each presented twice (mean interval between first and second presentations 9.1 images). The task was to indicate with the buttonpress device whether the image they were seeing was being presented for the first time (‘new’) or whether it had been presented earlier in the sequence (‘old’). The sequence was divided into eight blocks of 20 images, with a short break in between blocks. The interstimulus interval was jittered to an average of 12 s (range 6–18 s). Images were presented for 3000 ms and separated by a white fixation cross. For counterbalancing, four versions of the sequence were randomly assigned. The entire encoding task took ∼35 min, after which the drug was stopped and the subject removed from the scanner.|for 90 minutes after the drug/placebo was commenced||||ms||Standard Error|Mean
1250829|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250830|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Overall Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250831|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250832|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Emotional Well-being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250833|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250834|NCT00504881|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7= Marked improvement) with the start of the study medication as the reference time point. The Investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'|Baseline to Last Visit or Early Discontinuation Visit in the 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Evaluable subjects are subjects for whom the GES was completed by the investigator at last treatment period visit."|||units on a scale||Standard Deviation|Mean
1250841|NCT00504881|Secondary|Time to Tenth Type I Seizure During Treatment Period|Time to tenth Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1251221|NCT00501293|Primary|Diastolic Blood Pressure||Baseline and 6 months|Safety population|||mmHg||Standard Deviation|Mean
1250835|NCT00504881|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7= Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'|Baseline to last visit or early discontinuation visit in the 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Evaluable subjects are subjects who completed the GES at last treatment period visit."|||units on a scale||Standard Deviation|Mean
1250836|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate Anxiety and Depression.The HADS was developed as a self-administered scale to assess the presence and severity of Anxiety and Depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 (higher scores indicating greater problems). A negative value in change from Baseline indicates an improvement from Baseline.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250837|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate Anxiety and Depression. The HADS was developed as a self-administered scale to assess the presence and severity of Anxiety and Depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 (higher scores indicating greater problems). A negative value in change from Baseline indicates an improvement from Baseline.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250838|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250839|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1250840|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
1255321|NCT00467363|Secondary|Early Pregnancy Loss (EPL)|Implantation failures|8 weeks||||pregnancy|||Number
1250842|NCT00504881|Secondary|Time to Fifth Type I Seizure During the 16-week Treatment Period|Time to fifth Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1250843|NCT00504881|Secondary|Time to First Type I Seizure During the 16-week Treatment Period|Time to first Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1250844|NCT00504881|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|Baseline to 16-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.~Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."|||percentage of participants|||Number
1250845|NCT00504881|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period|"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:~(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)"|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percentage of participants|||Number
1250846|NCT00504881|Secondary|Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period|"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.~Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category."|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percentage of participants|||Number
1250847|NCT00504881|Secondary|Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|"Percent change from Baseline was calculated as percent reduction by:~(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).~A negative value in percent Change from Baseline indicates an improvement from Baseline.~The higher the negative values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline."|Baseline (Week 0) to end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
1250848|NCT00504881|Secondary|Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period|"There are three different types of seizures:~Type I: Partial seizures~Type II: Generalized seizures~Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||number of seizures per week||Inter-Quartile Range|Median
1250849|NCT00504881|Secondary|Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period|The responder rate was presented as the percentage of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in Partial Onset Seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percentage of participants|||Number
1250850|NCT00504881|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period|"Partial (Type I) seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to generalized tonic-clonic convulsions.~Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as:~(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline (Week 0) to the end of the Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||seizures per week||Inter-Quartile Range|Median
1250851|NCT00504881|Primary|Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Week 2 to the end of the Treatment Period (Week 16)|The Safety Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percentage of participants|||Number
1250865|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.|Day 28||||ratio||Standard Deviation|Mean
1250866|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.|Day 28||||seconds||Standard Deviation|Mean
1251222|NCT00501293|Primary|Systolic Blood Pressure||Baseline and 6 months|Safety population defined as all subjects that received at least one dose of MTS.|||mmHg||Standard Deviation|Mean
1250852|NCT00504777|Secondary|Change From Baseline in HAQ-DI Score|The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set are scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person is required. The HAQ-DI score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent “mild to moderate difficulty”, 1 to 2 as “moderate to severe disability”, and 2 to 3 as “severe to very severe disability”.|Week 24|ITT Population|||scores on a scale||Standard Deviation|Mean
1250853|NCT00504777|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants with a EULAR response at Week 24 based on a scale of good response, moderate response, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders have a change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders have a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders have a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population|||percentage of participants|||Number
1250854|NCT00504777|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) Response|ACR20/50/70 response defined as greater than or equal to (≥)20 percent (%), 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain, Patient Global Assessment of Disease Activity, Physician Global Assessment of Disease Activity, self-assessed disability based on the Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Week 24|ITT Population|||percentage of participants|||Number
1250855|NCT00504777|Primary|Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.|Week 24|ITT Population|||scores on a scale||Standard Deviation|Mean
1250856|NCT00504751|Primary|Complete Response|Complete Response|26 months||||participants|||Number
1250857|NCT00504725|Secondary|Verbal Pain Scores|Pain scores rated by the subject on a scale of 0 low - 10 high|baseline, 4 hours, 24 hours and at discharge||||units on a scale||Standard Deviation|Mean
1250858|NCT00504725|Secondary|C-reactive Protein (CRP) Serum Levels|The CRP levels were measured 24 hours postoperatively.|24 hours||||pg/ml||Standard Deviation|Mean
1250859|NCT00504725|Primary|Interleukin Levels at 24 Hours||24 Hours||||pg/ml||Standard Deviation|Mean
1250860|NCT00504660|Primary|6 Month Progression-free Survival for Participants With Glioblastoma|Progression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression.|6 months||||percentage of participants|||Number
1250861|NCT00504660|Primary|12 Month-progression-free Survival for Participants With Anaplastic Tumors|Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression.|12 months|Results from TMZ and CCNU treatment arms (Anaplastic Tumor-Glioma Arms 1 & 2) were combined in the final analysis because there was no statistically significant difference between them.|||percentage of participants|||Number
1250862|NCT00504595|Secondary|Efficacy of ACZ885 (Canakinumab) by Assessing the Response to Treatment Using the Disease Activity Score (DAS28)|DAS28 is derived by the number of swollen joints and tender joints using the 28-joint count (tender28 and swollen28). DAS28 measures the C-reactive protein (CRP) (in mg/L) and the patient's general health (GH). GH is measured on a 100 mm Visual Analogue Scale (VAS), ranging from no arthritis activity to maximal arthritis activity. DAS28 = 0.56*√(tender28) + 0.28*√(swollen28) + 0.36*log_e(CRP+1) + 0.014*PGDA + 0.96. Lower scores indicate less disease activity.|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.|||Scores on a scale||Standard Deviation|Mean
1250863|NCT00504595|Secondary|Efficacy of ACZ885 by Assessing the Response to Treatment Using the Simple Disease Index (SDAI)|SDAI is derived by the number of swollen joints and tender joints using the 28-joint count (tender28 and swollen28). SDAI measures the high sensitivity C-reactive protein (hsCRP) level, patient's global disease activity (PGDA) and evaluator's global disease activity (EGDA). PGDA and EGDA are measured on a 100 mm Visual Analogue Scale (VAS), ranging from no arthritis activity to maximal arthritis activity. SDAI = tender28 + swollen28 + CRP + (PGDA/10) + (EGDA/10). Lower scores indicate less disease activity.|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.|||Scores on a scale||Standard Deviation|Mean
1250864|NCT00504595|Primary|Response to Treatment (ACR20) in Adult Patients With Established Rheumatoid Arthritis (RA)|"At each post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures::~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.|||Participants|||Number
1251917|NCT00494494|Primary|Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)||baseline and 8 weeks||||microns||95% Confidence Interval|Mean
1250867|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b|"Mean (SD) change from baseline in biomarker prothrombinase induced clotting time [PICT] on Day 28, 1-3 hours post dose.~PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition."|Day 28||||seconds||Standard Deviation|Mean
1250868|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.|Day 28||||percent change of Endogenous FX activity||Standard Deviation|Mean
1250869|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.|Day 28||||IU/mL||Standard Deviation|Mean
1250870|NCT00504556|Secondary|Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b|Median (min, max) values of AUCss|3 months||||ng*h/mL||Full Range|Median
1250871|NCT00504556|Primary|Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)|liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities|3 months|safety analysis set|||percent subjects with liver related MA||95% Confidence Interval|Number
1250872|NCT00504556|Secondary|Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b|Median (min, max) values of Cmin,ss; Cmax,ss|3 months||||ng/mL||Full Range|Median
1250873|NCT00504556|Secondary|Effects on Biomarker Prothrombin Fragments|Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)|3 months||||pmol/L||Standard Deviation|Mean
1250874|NCT00504556|Secondary|Effects on Biomarker D-dimer|Mean (SD) change from baseline in D-dimer|3 months||||ng/mL||Standard Deviation|Mean
1250875|NCT00504556|Primary|Adjudicated Incidence of Bleeding Events|Adjudicated Incidence of Bleeding Events during treatment period|3 months|safety analysis set|||percent of subjects with outcome event||95% Confidence Interval|Number
1250876|NCT00504556|Secondary|Incidence of Major Adverse Cardiac Events MACE)|MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition|3 months|safety analysis set|||percent of subjects experiencing events||95% Confidence Interval|Number
1250877|NCT00504504|Primary|5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD|Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.|Baseline to 5 Years or until disease progression||||percentage of participants|||Number
1250878|NCT00504426|Secondary|Improvement Rate of Pain (Doctor's Judgment)|"Percentage of participants qualified for improvement of pain by doctor's judgement.~Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend.~Improvement defind by stopped or almost stopped or alleviated."|Baseline and Week 4||||Percentage of Participants||95% Confidence Interval|Number
1250879|NCT00504426|Primary|Pain (Subjective Symptom)|"Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline.~Regarding VAS (dotted onto a 100 mm line), 0 mm means No Pain and 100 mm means Worst Pain Imaginable."|Baseline and Week 4||||mm||Standard Deviation|Mean
1250880|NCT00504309|Secondary|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)|"Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI).~HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL * insulin mU/L) / 405.~QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))."|8 weeks||||index units||Standard Error|Mean
1250881|NCT00504309|Secondary|Fasting Insulin|Effect of P-OM3 dose on fasting insulin|8 weeks||||μIU/mL||Standard Error|Mean
1250882|NCT00504309|Secondary|C-reactive Protein (CRP)|Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP|8 weeks||||mg/L||Standard Error|Mean
1250883|NCT00504309|Secondary|Psychosocial Profile Questionnaires|"Effect of P-OM3 dose on psychosocial questionnaires:~Perceived Stress Scale (PSS)~14 questions, scored 0-4 based on how often the subject felt certain emotions~Scores: 0 to 40; higher scores indicate higher perceived stress~Spielberger State Anxiety Inventory~Levels of state anxiety (situational) and trait anxiety; 40 items scored by a Likert scale~Scores: 20 to 80; higher scores indicate higher levels of anxiety~Positive and Negative Affect Scales (PANAS)~Two 10-item scales; each item is rated on a Likert scale of 1 (not at all) to 5 (very much).~Scores: 10 to 50, with higher scores representing higher levels of positive or negative affect~Center for Epidemiologic Studies Depression (CES-D) Scale~20 questions about symptoms of depression in the past week~Scores: 0 to 60; higher scores indicate more symptomology. Score of 16 or higher indicates a risk for depression and should be followed by further evaluation by a qualified health professional"|8 weeks||||scores on a scale||Standard Error|Mean
1250884|NCT00504309|Secondary|Fasting Glucose|Effect of P-OM3 dose on fasting glucose|8 weeks||||mg/dL||Standard Error|Mean
1250885|NCT00504309|Secondary|Cytokine Inflammatory Markers|Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma|8 weeks||||pg/mL||Standard Error|Mean
1250886|NCT00504309|Secondary|Erythrocyte Fatty Acids|Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells|8 weeks||||percentage||Standard Error|Mean
1250887|NCT00504309|Primary|Heart Rate|Effect of P-OM3 dose on heart rate|8 weeks||||beats per minute||Standard Error|Mean
1250888|NCT00504309|Primary|Blood Pressure|Effect of P-OM3 dose on blood pressure|8 weeks|Two participants did not complete the study and were therefore excluded from analysis.|||mm Hg||Standard Error|Mean
1250889|NCT00504309|Primary|Flow-mediated Dilation (FMD)|Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period.|8 weeks||||% change in brachial artery diameter||Standard Error|Mean
1250890|NCT00504309|Primary|Lipid Profile|Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol.|8 weeks||||mg/dL||Standard Error|Mean
1251918|NCT00494494|Primary|Foveal Thickness|difference in mean pre-post changes by the two treatment groups|baseline and 8 weeks||||microns||95% Confidence Interval|Mean
1250891|NCT00504257|Secondary|Overall Survival (OS)|Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) were analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.|Up to 5 years|All evaluable participants|||months||95% Confidence Interval|Median
1250892|NCT00504257|Secondary|Occurrence of Grade 3 or 4 Toxicity|Number of participants with Grade 3 or 4 Toxicity based on 278 treatment cycles. Toxicity was graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 4 years|All evaluable participants|||participants|||Number
1250893|NCT00504257|Secondary|Overall Response Rate (RR)|Overall Response: Complete Response (CR) + Partial Response (PR). To determine the response rate (RR) of the investigational treatment regimen. Response and progression were evaluated in the study by using the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) method or modified Rustin Criteria for CA-125 measurements.|Up to 5 years|Response Rate (RR) evaluable patients included all patients who received at least 2 cycles of treatment and at least one tumor assessment or had demonstrated clinical progression.|||participants|||Number
1250894|NCT00504257|Secondary|Median Progression Free Survival|"PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.~Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions."|Up to 5 years|All evaluable participants|||months||95% Confidence Interval|Median
1250895|NCT00504257|Primary|Six Month Progression Free Survival (PFS)|"Percentage of participants with PFS at six months. PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.~Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions."|6 months per participant|All evaluable participants|||percentage of participants||95% Confidence Interval|Number
1250896|NCT00504231|Secondary|Assessment of Reactogenicity|Maximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment|1 week||||participants|||Number
1250897|NCT00504231|Secondary|Geometric Mean Titer (GMT) Pre- and Post- Vaccination|GMT before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) IM or Reduced-Dose (9 mg) ID Injections. A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)|1 month||||GMT||95% Confidence Interval|Geometric Mean
1250898|NCT00504231|Primary|Seroprotection Pre- and Post- Vaccination|Seroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)|1 month||||% of Participants|||Number
1250899|NCT00504166|Primary|Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT|Trabecular number is a three-dimensional measure of the mean inter-trabecular distance; the primary micro-architectural feature measured by high-resolution CT imaging. The parameter was calculated from scans of the distal radius and distal tibia at baseline, 12, and 24 months. The percent change from baseline over these time periods was calculated as the primary outcome measure indicating the micro-architectural status of trabecular bone.|Baseline, 24 months|final statistical analysis was performed per protocol|||Percent change||Standard Deviation|Mean
1250900|NCT00504153|Secondary|Change in Plasma Vascular Endothelial Growth Factor (VEGF) Levels Over 15 Days|Changes of VEGF will be correlated with response rates and 4-month progression-free survival utilizing the Wilcoxon rank-sum test.|At baseline and day 15|This outcome was not assessed for any of the patients.||||||
1250901|NCT00504153|Secondary|Association Between the Incidence of Total C-src and Phosphorylated C-src Expression and Response|Examined by comparing expression in those who have an objective response versus those who do not and in those with and without disease progression at 4 months using Fisher’s exact test.|4 months|This outcome was not assessed for any of the patients.||||||
1250902|NCT00504153|Secondary|Incidence of Somatic Mutations|Multivariable analysis of progression-free survival duration will be performed using the Cox (1972) regression model to evaluate the prognostic value of somatic mutations. For the mutational analysis endpoints, genetic mutations will also be correlated with drug activity via Fisher’s exact test for comparisons of responders with non-responders and for comparison of patients progression-free and 4 months vs. those with early progression or death|1 year|This outcome was not assessed for any of the patients.||||||
1250903|NCT00504153|Secondary|Response Rate (RR) (Complete or Partial Responders)|Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. The response rate is the proportion of subjects who experienced a complete or partial response.|Every 2 courses, assessed up to 8 weeks after completion of study treatment (i.e., up to 10 months)||||percentage of participants|||Number
1250904|NCT00504153|Primary|Progression-free Survival Rate|Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Patients who are still alive and have not progressed will be censored at the date of the last negative examination. A Simon (1989), optimal, two-stage design will be employed. The progression-free survival count will be the proportion of subjects who are alive and progression-free at 4 months.|From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.)||||percentage of participants|||Number
1250905|NCT00504075|Secondary|Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.|Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.|Days 1, 2, 3, 5, 9, 14, 21, 32.|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.|||days||95% Confidence Interval|Median
1251271|NCT00500370|Secondary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)|24 weeks|Intent to Treat population|||percent||Standard Error|Least Squares Mean
1250906|NCT00504075|Secondary|The Safety of GAMMAPLEX at the Dosage Used in This Study.|"The safety variables used to assess safety were the following:~Adverse events~The number and percent of infusions with at least 1 adverse event(AE) that occurs during an infusion or within 72 hours after the infusion stops~Nature, severity, and frequency of AEs~Suspected unexpected serious adverse reactions (SUSARs)~Vital signs~Clinical laboratory tests and Direct Coombs’ Test~Transmission of viruses~Physical examination"|AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.|||% of subjects with product related SAEs||95% Confidence Interval|Number
1250907|NCT00504075|Primary|The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.|The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.|9 days|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.|||participants|||Number
1250908|NCT00504023|Primary|Percentage of Participants With Clinical and Histologic Remission|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|12 weeks post treatment||||% of participants|||Number
1250909|NCT00503997|Primary|Patient Response to Treatment Measured by RECIST Criteria|RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|at 8 weeks||||participants|||Number
1250910|NCT00503984|Secondary|Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.||Up to 4.5 years|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.|||participants|||Number
1250911|NCT00503984|Secondary|Overall Survival (OS)|The time from the date of initiation of study treatment until date of death from any cause.|Up to 4.5 years.||||months||95% Confidence Interval|Median
1250912|NCT00503984|Secondary|Progression-Free Survival (PFS)|The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier.|Up to 4.5 years||||months||95% Confidence Interval|Median
1250913|NCT00503984|Secondary|Duration of Response|Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.|Up to 4.5 years.|The 10 participants in both Phase 1 and Phase 2 who achieved PSA response.|||weeks||Full Range|Median
1250914|NCT00503984|Primary|Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.|"Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; "|Up to 4.5 years|Number of evaluable participants with measurable disease on CT scan. Only 10 of the 19 evaluable participants had measurable disease on CT Scan.|||participants|||Number
1250915|NCT00503984|Primary|Number of Participants Achieving Prostate-specific Antigen (PSA) Response.|Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.|Up to 4.5 years.|Of the 22 participants enrolled, only 19 were evaluable because they completed 2 or more cycles of protocol therapy.|||participants|||Number
1250916|NCT00503984|Primary|Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)|Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.|Up to 1.5 years|Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.|||mg|||Number
1250917|NCT00503984|Primary|Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)|Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.|Up to 1.5 years|Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.|||mg/m2|||Number
1250918|NCT00503906|Post-Hoc|Rate of Overall Survival in Study Participants|Rate of overall survival in study participants. Overall survival will be measured from the date of enrollment to the date of death from any cause, or the date of last contact (censored observations.)|18 months||||percentage of participants||95% Confidence Interval|Median
1250919|NCT00503906|Secondary|Relationship Between SPARC Expression and Response to Protocol Therapy.|Relationship between SPARC expression and response to this chemotherapy combination and relation to progression free survival.|Baseline, over the course of treatment, about 1 year|Data were not collected for this outcome measure.||||||
1253863|NCT00478140|Secondary|Disease Control Rate|Percentage of participants who have achieved complete response, partial response and stable disease|Up to 3.5 years|||||||
1250920|NCT00503906|Secondary|Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment|Exploration of the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.|Baseline, over the course of Treatment, about 1 year|Data were not collected for this outcome measure.||||||
1250921|NCT00503906|Secondary|Rate of Toxicity in Study Participants|Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.|Over the course of study treatment.||||percentage of participants|||Number
1250922|NCT00503906|Secondary|Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants|Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.|After two cycles, about 60 days|Evaluable patients are study-eligible patients who receive an initial infusion of combination chemotherapy consisting of Gemcitabine, NAB paclitaxel and Bevacizumab and have had at least one CT scan for evaluation of disease status.|||percentage of participants|||Number
1250923|NCT00503906|Primary|Median Progression-Free Survival|Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.|Up to 24 months||||months||95% Confidence Interval|Median
1250924|NCT00503880|Secondary|Changes in Flow of Cytometric Patterns.|To assess changes in flow cytometric patterns.|7 months|||||||
1250925|NCT00503880|Secondary|Cytogenetic Response Rates|To assess cytogenetic response rates.|7 months|||||||
1250926|NCT00503880|Secondary|Time to Acute Myelooid Leukemia Transformation or Death.|To assess the time to acute myeloid leukemia transformation or death.|7months|||||||
1250927|NCT00503880|Secondary|Quality of Life|To assess effects on quality of life of this patient population.|7 months|||||||
1250928|NCT00503880|Primary|Presence of Hematologic Response (Phase II)|"These are measured in patients with pretreatment abnormalities defined as:~Hemoglobin < 11 g/dL or transfusion dependence [erythroid- E] Platelets less than 100 x 109/L or platelet-transfusion dependence [platelet- P] Absolute neutrophil count (ANC) less than 1.0 x 109/L [neutrophil- N] Pretreatment baseline measures of cytopenias are averages of at least 2 measurements (not influenced by transfusions)- at least 1 week apart."|Following phase I, responses must last at least 8 weeks.|The study only enrolled 2 patients of the planned 30. The two patients enrolled did not complete the research as planned and were not evaluable. The study was closed due to lack of funding support. Data were not collected.||||||
1250929|NCT00503880|Primary|Maximum Tolerated Dose of Clofarabine (Phase I)|Maximum Tolerated Dose (MTD) is defined to be the dose cohort below which 2 out of 6 patients experience dose limiting toxicities or the highest dose cohort, if 2 limiting toxicities are not observed at any dose cohort. These will be presented as actual rates. Dose limiting toxicity (DLT) will be defined according to oncology standards based on NCI CTC version 2 grading criteria (DLT = > grade 3 non-hematological toxicity or any > 4 hematological toxicity that persists for more than 4 weeks and in the opinion of the investigator is felt not to be due to disease).|7 months|||||||
1250930|NCT00503841|Secondary|Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride||At day -7, prior to surgery, and 1 week post-surgery|||||||
1250931|NCT00503841|Secondary|Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)||Baseline and day 0|||||||
1250932|NCT00503841|Secondary|Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer||Baseline and day 0|||||||
1250933|NCT00503841|Primary|Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer||Baseline and day 0|No participants received the study drug erlotinib hydrochloride.||||||
1250934|NCT00503776|Secondary|Changes in the Frequency and Types of Dietary Intakes|Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.|at baseline, at 1 month, 3 months and 6 months post-chemoradiation|Due to loss of funding, sufficient data for analysis was not collected.||||||
1250935|NCT00503776|Secondary|Changes in the Amount and Texture of Food Consumed|Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.|at baseline, at 1 month, 3 months and 6 months post-chemoradiation|Due to loss of funding, sufficient data for analysis was not collected.||||||
1250936|NCT00503776|Secondary|Number of Patients With Oral Mucositis by Grade|Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).|6 months after concurrent chemotherapy and radiation|Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2).|||participants|||Number
1250937|NCT00503776|Secondary|Stimulated and Unstimulated Salivary Production|Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.|6 months after concurrent chemotherapy and radiation|Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2)|||mL per minute||Standard Deviation|Mean
1250938|NCT00503776|Primary|Number of Patients With Each Degree of Swallowing Dysfunction|Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment|6 months after concurrent chemotherapy and radiation|One patient (Arm 2B) did not undergo the 6-month study|||participants|||Number
1251854|NCT00495131|Primary|Sustained Virologic Response|Undetectable HCV RNA 6 months off therapy|18 months|Intention-to-treat (ITT) analysis by last observation carried forward|||participants|||Number
1250939|NCT00503750|Secondary|Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.|"Complete clinical response (CCR): complete disappearance of all measurable malignant disease. No new malignant lesion, disease-related symptoms or evidence of non-evaluable disease.~Partial response (PR): Reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.~Stable disease (SD): For bidimensionally measurable disease, no decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions."|clinic examination every 2 weeks, evaluated every 3 months for 2 years post-op||||participants|||Number
1250940|NCT00503750|Primary|Number of Participants With Complete Pathologic Response.|"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR.~Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response."|assess at 8 weeks||||participants|||Number
1250941|NCT00503698|Secondary|Health Related Quality of Life Assessments|Summary from activity of daily living from the Rotterdam Symptom Checklist (RSCL) measuring activity from 1 (active) to 5 (inactive). The Edmonton Symptom Assessment System (ESAS), subjects assess their health in the last 24 hours on a scale from 1 (good health) to 3 (feeling poorly). The EQ-5D is a measure of subjects' health outcome from 0 (death) to 1 (full health). SF-36 (Short Form (36)) covering mental and physicial health is provided in a scale from 0-100 with higher scores indicating greater satisfaction.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Observations from end of trial visit is substitute for week 104. Not all subjects provided 'quality of life' data.|||scores on a scale||Standard Deviation|Mean
1250942|NCT00503698|Secondary|Mortality - Two-year Mortality Rate||week 0, trial termination|No analysis was done since the trial was prematurely terminated before week 104 of the trial. Trial was terminated January 16th, 2009.||||||
1250943|NCT00503698|Secondary|Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures|The number of times that the patient was hospitalised in addition to hospitalisation for normal dialysis procedures measured from week 0 (randomisation) to the time the trial was terminated.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).|||hospitalisations||Standard Deviation|Mean
1250944|NCT00503698|Secondary|Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)|Morbidity - time from week 0 to next cardiovascular event (composite of all-cause mortality and cardiovascular events defined as adjudicated medical event of special interest and categorised as myocardial infarctions, cardiac insufficiencies, strokes or other thrombo-embolic events). Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants with events estimated using Kaplan-Meier. Summary data illustrates morbidity until 52 weeks, because very few subjects had trial time longer than 52 weeks.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 (end of trial per protocol).|||percentage of participants|||Number
1250945|NCT00503698|Primary|Mortality - Time to All-cause Death|Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).|||percentage of participants|||Number
1250946|NCT00503685|Secondary|Expression of IGF Binding Proteins (IGFBP2, IGFBP3)||Randomization/treatment up to 26.9 months|Zero participants analyzed. No data collected for analysis.||||||
1250947|NCT00503685|Secondary|Expression of Type I Insulin-Like Growth Factor Receptors (IGF-IR)||Randomization/treatment up to 26.9 months|Zero participants analyzed. No data collected for analysis.||||||
1250948|NCT00503685|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR, Response Rate) in Participants With Kirsten Rat Sarcoma (K-ras) Mutations|The response rate in participants with K-ras mutations was not collected for analysis.|Treatment up to 26.9 months|Zero participants analyzed. Response rate data was not collected for analysis due to N=0 CR and N=1 PR.||||||
1250949|NCT00503685|Secondary|Area Under Serum Concentration (AUC)||Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)|Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.||||||
1250950|NCT00503685|Secondary|Minimum Concentration (Cmin)||Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)|Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.||||||
1250951|NCT00503685|Secondary|Maximum Concentration (Cmax)||Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)|Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.||||||
1250952|NCT00503685|Secondary|Number of Participants Reporting Treatment-Emergent Severe Adverse Events|Data presented are the number of participants who experienced serious adverse events (SAEs) or death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Randomization/treatment up to 26.9 months|All randomized/enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1250953|NCT00503685|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)|Data presented are the number of participants who experienced nonserious adverse events (AEs) during the study including the 30-day follow-up. A summary of serious AEs (SAEs) and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Randomization/treatment up to 26.9 months|All randomized/enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1250954|NCT00503685|Secondary|Duration of Overall Response|The duration of overall response (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of PD or death due to any cause. CR, PR and PD were determined using RECIST criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of overall response was censored at their last tumor assessment prior to the cutoff date. Duration of overall response was not analyzed due to low number of participants with CR or PR.|Time of response to time of measured PD or death up to 161 days|Zero participants analyzed. Duration of Response for CR or PR data was not collected for analysis due to N=0 CR and N=1 PR.||||||
1250955|NCT00503685|Secondary|Duration of Stable Disease (SD)|The duration of SD is measured from the date of randomization/treatment until the date of PD. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. RECIST criteria version 1.0 was used to asses PR and PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants who had no PD or death at the time of the data inclusion cutoff, duration of SD was censored at their last tumor assessment prior to the cutoff date.|Time from randomization/treatment to first date of PD up to 28.3 weeks|All randomized/enrolled participants who received at least 1 dose of the study drug and achieved SD or better. The number of participants censored was 0 for IMC-A12 group, 0 for IMC-A12 + cetuximab group and 1 for IMC-A12 + cetuximab (K-ras wild-type) group.|||weeks||95% Confidence Interval|Median
1250956|NCT00503685|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of randomization/treatment to the date of death from any cause. Participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.|Randomization/treatment to date of death from any cause up to 26.9 months|All randomized/enrolled participants who received at least 1 dose of study drug. The number of participants censored was 5 for IMC-A12 group, 4 for IMC-A12 + cetuximab group and 11 for IMC-A12 + cetuximab (K-ras wild-type) group.|||months||95% Confidence Interval|Median
1250957|NCT00503685|Secondary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of randomization/treatment to the date of PD or death from any cause. PD was determined using RECIST criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the cutoff date. Participants who began a new antitumor treatment before evidence of PD were categorized as PD.|Randomization/treatment to measured PD up to 28.3 weeks|All randomized/enrolled participants who received at least 1 dose of study drug. The number of participants censored was 0 for IMC-A12 group, 1 for IMC-A12 + cetuximab group and 1 for IMC-A12 + cetuximab (K-ras wild-type) group.|||weeks||95% Confidence Interval|Median
1250958|NCT00503685|Primary|Percentage of Participants With Complete Response (CR) or Partial Response [PR, Objective Response Rate (ORR)]|ORR is the percentage of participants with a confirmed CR or PR, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from start of the treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|Start of randomization/treatment to date of objective progressive disease (PD) up to 28.3 weeks|All randomized/enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1250959|NCT00503425|Secondary|Change From Baseline in Bone Density Score at Weeks 48 and 104|Bone density or bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD test results are compared to the ideal or peak BMD of a healthy 30-year-old adult, and results are provided as T-score. A score of 0 means BMD is equal to the norm for a healthy young adult. Differences between observed BMD and that of the healthy young adult norm are measured in units called standard deviations (SDs). The more standard deviations below 0, indicated as negative numbers, lower the BMD higher the risk of fracture. SD + 1 to -1 indicates normal BMD; SD between -1 to -2.5 indicates low bone mass, SD -2.5 or lower indicates osteoporosis. Change in bone density was measured in participants who were not treated with biphosphonates by Dual Energy X-Ray Absorptiometry. Change in bone density was assessed at baseline and at Weeks 48 and 104. Change from baseline in bone density score was reported for all 5 courses.|Baseline, Weeks 48 and 104 (End of treatment)|ITT population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.|||T-score||Standard Deviation|Mean
1250960|NCT00503425|Secondary|Percentage of Participants With EULAR DAS 28 Response at Week 24|Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Week 24. EULAR response was based on change from baseline (COB) in DAS28 score and also on actual DAS28 score, at Week 24. DAS28 score= participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: 0.56*√TJC+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score=0-10, higher scores represented higher disease activity. Scores below 2.6: clinical remission, </=3.2: low disease activity, </=5.1: moderate disease activity, above 5.1: severe disease. EULAR Good response: DAS28</=3.2; COB<-1.2. Moderate response: DAS28</=3.2 or >3.2 to </=5.1 or >5.1; COB <-1.2 or <-0.6 to greater than or equal to (>/=)-1.2. No response: DAS28 </=3.2 or > 3.2 to </=5.1 or >5.1; COB <-0.6 to >/=-1.2 or >/=-0.6. EULAR response was reported for 5 courses.|Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.|||Percentage of participants|||Number
1251021|NCT00502853|Secondary|X-Rays: Right Hand Total Score|Right hand total scores as measured by X-rays examining erosion and joint space narrowing. Total score was calculated as the sum of the erosion score and the joint space narrowing score and scores ranged from 0 (best possible outcome) to 180 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.|||units on a scale||Standard Deviation|Mean
1250961|NCT00503425|Secondary|Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24|DAS28 score is a measure of participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated according to following formula: [0.56*√TJC] + [0.28*√SJC] + [0.70*ln ESR] + [0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of </= 3.2 indicated low disease activity, score of </= 5.1 indicated moderate disease activity, and scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses. Participants whose DAS28 score improved by 1.2 score were reported.|Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.|||Percentage of participants|||Number
1250962|NCT00503425|Secondary|Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24|DAS28 score is a measure of participant's disease activity calculated using tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity (PGH) [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: 0.56 multiplied by (*) square root (√) of TJC] plus (+) [0.28*√SJC]+[0.70*the natural logarithm (ln) ESR]+[0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (</=) 3.2 indicated low disease activity, score of </=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses.|Baseline, Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.|||Units on a scale||Standard Deviation|Mean
1250963|NCT00503425|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of SAEs.|Baseline up to study withdrawal or follow-up (Approximately 104 weeks)|Safety population included all participants who had received any part of an infusion of study medication.|||Participants|||Number
1250964|NCT00503399|Secondary|Number of Participants With Adverse Events (AEs)|Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of >2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter [mg/dL]).|Baseline up to 18 months|The safety analysis set included all participants who received study treatment.|||participants|||Number
1250965|NCT00503399|Secondary|Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months|β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix.|3, 6, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||nanograms per deciliter (ng/dL)||Standard Error|Least Squares Mean
1250966|NCT00503399|Secondary|Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months|P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid.|Baseline, 3 months, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||micrograms per deciliter (μg/dL)||Standard Error|Least Squares Mean
1250967|NCT00503399|Secondary|Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months|Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip.|Baseline, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||grams per square centimeter (g/cm^2)||Standard Deviation|Mean
1250968|NCT00503399|Secondary|Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength|Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||Newton per millimeter (N/mm)||Standard Error|Least Squares Mean
1250969|NCT00503399|Secondary|Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength|Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||Newton/millimeter/radian (N/mm/rad)||Standard Error|Least Squares Mean
1255322|NCT00467363|Secondary|Clinically Recognized Pregnancy||8-weeks||||pregnancy|||Number
1250970|NCT00503399|Secondary|Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months|Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
1250971|NCT00503399|Secondary|Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months|Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months|The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.|||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
1250972|NCT00503399|Primary|Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months|Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 18 months|The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.|||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
1250973|NCT00503308|Primary|Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)|We measured decisional conflict, the primary outcome of the study, using the English or Spanish language 10-item Low Literacy Decisional Conflict Scale. We considered a DCS score of 25 or less to be low, corresponding to limited conflict. All questions have 3 response categories: yes, no, unsure. Items are scored as 0 = yes, 2 = unsure, 4 = no. Scores for each of the 10 items are summed, divided by 2 and multiplied by 25 to calculate the total score. The final scores range from 0(no decisional conflict) to 100 (extremely high decisional conflict).|same day as HIV test counseling (cross-sectional study)||||scores on scale||95% Confidence Interval|Mean
1250974|NCT00503139|Secondary|European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)|DAS28-3 (ESR) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count and ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom DAS28 (3/ESR) was calculated. The last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants||95% Confidence Interval|Number
1250975|NCT00503139|Secondary|Visual Analog Fatigue Scale (VAFS)|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom VAS Fatigue was calculated. The last observation carried forward (LOCF) method was used to impute missing data.|||Score||Standard Deviation|Mean
1250976|NCT00503139|Secondary|Modified Health Assessment Questionnaire (mHAQ) Score|Modified Health Assessment Questionnaire-(mHAQ): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom mHAQ was calculated. The last observation carried forward (LOCF) method was used to impute missing data.|||Score||Standard Deviation|Mean
1250977|NCT00503139|Primary|European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom DAS28 (4/ESR) was calculated. The last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants||95% Confidence Interval|Number
1250978|NCT00503139|Primary|Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.|||Participants|||Number
1251272|NCT00500370|Secondary|Change in High Sensitivity C-reactive Protein (hsCRP)|Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)|24 weeks|Intent to Treat population|||pmol/L||Standard Error|Least Squares Mean
1250979|NCT00503139|Primary|Number of Participants With Serious Treatment Related Adverse Events of Etanercept|Serious treatment-related adverse events are defined as any events that lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.|||Participants|||Number
1250980|NCT00503139|Primary|Number of Participants With Treatment Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.|||Participants|||Number
1250981|NCT00503139|Primary|Number of Participants in Safety Analysis Population of Etanercept||3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.|||Participants|||Number
1250982|NCT00503113|Secondary|Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.|The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.|Baseline and 9 months|PP Population|||mg/g||Standard Deviation|Mean
1250983|NCT00503113|Secondary|Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.||Baseline and 9 months|PP Population|||mg/g||Standard Deviation|Mean
1250984|NCT00503113|Secondary|Relative Change From Baseline in Mean Serum Creatinine.||Baseline and 9 months|PP Population|||mg/dL||Standard Deviation|Mean
1250985|NCT00503113|Secondary|Absolute Change From Baseline in Mean Serum Creatinine.||Baseline and 9 months|PP Population|||mg/dL||Standard Deviation|Mean
1250986|NCT00503113|Secondary|Relative Change From Baseline in Actual GFR (Using CG Formula)|Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population|||mL/min||Standard Deviation|Mean
1250987|NCT00503113|Secondary|Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)|Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population|||mL/min||Standard Deviation|Mean
1250988|NCT00503113|Secondary|Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)|Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population|||mL/min||Standard Deviation|Mean
1250989|NCT00503113|Primary|Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)|The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients’ actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|Per Protocol (PP) Population|||mL/min||Standard Deviation|Mean
1250990|NCT00503009|Secondary|Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4|eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4|||||||
1250991|NCT00503009|Secondary|Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4|FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4|||||||
1250992|NCT00503009|Secondary|Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4|PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4|||||||
1250993|NCT00503009|Primary|Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4|The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4|||||||
1250994|NCT00502996|Secondary|Mean Value of Inflamed Joints|The efficacy of rituximab was assessed by evaluating inflamed joints.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||number of inflamed joints||Standard Deviation|Mean
1250995|NCT00502996|Secondary|Mean Values of Pain and Activity Based on Visual Analogue Scale|Pain assessment was assessed by using a VAS (0=no pain to 100=unbearable pain). Disease activity was also evaluated by participants and investigators by using a VAS (0=no disease activity to 100=maximum disease activity).|Screening ((Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||Scores on scale||Standard Deviation|Mean
1250996|NCT00502996|Secondary|Mean Values of Globular Sedimentation Velocity|Globular sedimentation velocity is a component of ACR.|Screening ((Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||millimeters per hour||Standard Deviation|Mean
1250997|NCT00502996|Secondary|Mean Values of C Reactive Protein|C Reactive Protein (CRP) is a component of ACR. CRP is a marker of inflammation.|Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||milligrams per liter||Standard Deviation|Mean
1251273|NCT00500370|Secondary|Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)|Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24|24 weeks|Intent to Treat population|||Participants|||Number
1250998|NCT00502996|Secondary|Mean Value of Quality of Life (Health Assessment Questionnaire – Disease Index)|Health Assessment Questionnaire - Disease Index (HAQ-DI) indicates how the disease affected participant’s activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).|Screening (Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||Scores on scale||Standard Deviation|Mean
1250999|NCT00502996|Secondary|Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria|American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender joints and swollen joints, as well as for three of the additional five ACR core set variables: patient’s assessment of pain using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain); patient’s global assessment of disease activity and physician’s global assessment of disease activity using a VAS (0=no disease activity to 100=maximum disease activity); health assessment questionnaire (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant; C-reactive protein and globular sedimentation velocity.|Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||participants|||Number
1251000|NCT00502996|Secondary|Mean Value of Painful Joints|The efficacy of rituximab was assessed by evaluating painful joints.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||number of painful joints||Standard Deviation|Mean
1251001|NCT00502996|Secondary|Mean Duration of Morning Joint Stiffness|The efficacy of rituximab was assessed by evaluating mean duration of morning joint stiffness.|Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||Minutes||Standard Deviation|Mean
1251002|NCT00502996|Secondary|Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit|The mean aspartate transaminase (AST) and alanine transaminase (ALT), Alkaline phosphatase (AP), and Lactic dehydrogenase (LDH) concentration for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||International units/liter||Standard Deviation|Mean
1251003|NCT00502996|Secondary|Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit|The mean concentration of potassium, chlorine, sodium and phosphorus for each participant was estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||millimoles per liter||Standard Deviation|Mean
1251004|NCT00502996|Secondary|Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.|The mean concentration of cholesterol, uric acid, urea, creatinine, calcium, total bilirubin and serum total proteins (STP) for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||mg/dL||Standard Deviation|Mean
1251005|NCT00502996|Secondary|Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)|The mean albumin and glucose concentration for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||g/dL||Standard Deviation|Mean
1251006|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)|The mean leucocytes and platelets concentration for each participant was estimated at Screening, at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||10^9 cells/liter||Standard Deviation|Mean
1251007|NCT00502996|Secondary|Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)|The mean erythrocyte concentration for each participant was estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||10^12 cells/liter||Standard Deviation|Mean
1251008|NCT00502996|Secondary|Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)|Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant was estimated at Screening and EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The analysis was performed on safety population. Eligible participants who received one treatment dose of Rituximab, have completed the follow-up period, Visit 11, and end of follow-up period in safety conditions and also who had been withdrawn or not from the study were included in the safety population.|||femtoliters||Standard Deviation|Mean
1251009|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)|The hematology parameters (hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, and basophils) for each participant were estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||percentage of cells||Standard Deviation|Mean
1251855|NCT00495131|Secondary|Treatment-related Withdrawal Rate|Treatment-related withdrawal rate: patients who prematurely discontinued treatment due to treatment-related adverse events|18 months||||Participants|||Number
1251010|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)|The values of hemoglobin (Hb) and mean corpuscular hemoglobin concentration (MCHC) for each participant were estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||g/deciliter (dL)||Standard Deviation|Mean
1251011|NCT00502996|Primary|Number of Participants With AEs of Special Interest During the Study|Adverse event of special interest during the study treatment and follow up period included infections. The participants with AEs of special interest were reported at Screening, End of treatment (EOT), and End of Follow-up (EOFU) visit.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||participants|||Number
1251012|NCT00502996|Primary|Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs|"An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A SAE is any experience that suggested a significant risk, contraindication, caution, and at any dose, fulfills, at least, one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment. Relationship between AEs and medication under investigation was evaluated through the classification Yes and No. A relationship classified as Yes implied a significant causal relationship with the medication under investigation which was evaluated based on enough evidences, facts or arguments."|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||participants|||Number
1251013|NCT00502996|Primary|Number of Participants With AEs According to Degree of Intensity|An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. The Intensity of AEs was classified as Grade 1, Grade 2, Grade 3 and Grade 4. Grade 1: Discomfort was noticed, but the normal daily activity was not interrupted. Grade 2: Discomfort was enough to reduce the normal daily activity. Grade 3: There was disability for work or develop normal daily activities. Grade 4: It represented an immediate threat to life (these events were reported as SAEs).|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||participants|||Number
1251014|NCT00502996|Primary|Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death|An Adverse event (AE) was considered any unfavorable medical event in a participant of clinical research who received the study drug and that not necessarily had a causal relationship with this treatment. An AE could, therefore, being any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A serious adverse event (SAE) is any experience that suggested a significant risk, contraindication, caution, and at any dose fulfills at least one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment.|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||participants|||Number
1251015|NCT00502944|Primary|Linkage to Care of Newly Diagnosed HIV Infected Participants|We define linkage to care as attendance at a first HIV clinic appointment where the following 3 events occur: 1) introduction to an HIV care primary provider; 2) receipt of confirmatory Western Blot HIV test results; and 3) phlebotomy for CD4 cell count and HIV RNA level.|Assessed within 8 weeks after receipt of reactive rapid HIV test results|DSMB recommended the trial be ended early for likely inability to obtain this primary outcome. Thus the outcomes reported in paper are the secondary and other pre-specified outcomes listed.|||participants|||Number
1251016|NCT00502944|Other Pre-specified|Test Acceptance Rate|Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test.|Assess on day subject enrolled into the study|Number of participants analyzed equals the number of participants offered a rapid HIV test. Many participants left the ED before the opportunity was available to offer the test.|||participants|||Number
1251017|NCT00502944|Other Pre-specified|Test Offer Rate|The offer rate of the HIV test was defined as the proportion of enrolled study participants who were actually offered a test.|Assess on day subject enrolled into the study||||participants|||Number
1251018|NCT00502944|Secondary|Overall Rapid HIV Testing Rate|We defined the overall rapid HIV testing rate as the number of participants tested for HIV using the rapid test among those randomized to potentially be tested in each arm.|Assess on day subject enrolled into the study|Intention to treat analysis|||participants|||Number
1251019|NCT00502905|Primary|Number of Participants With Successful Engraftment|Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28.|Study period one week prior to transplant through post Day 28|Analysis per protocol.|||participants|||Number
1251020|NCT00502853|Secondary|X-Rays: Left Hand Total Score|Left hand total scores as measured by X-rays examining erosion and joint space narrowing. Total score was calculated as the sum of the erosion score and the joint space narrowing score and ranged from 0 (best possible outcome) to 180 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.|||units on a scale||Standard Deviation|Mean
1253528|NCT00482014|Primary|Phase 2 - Survival Probability at 2 Years||Phase 2 randomization up to 2 years|All randomized participants in Study Phase 2.|||percentage survival||95% Confidence Interval|Mean
1251022|NCT00502853|Secondary|Joint Space Narrowing - Left Hand|Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4. A normal joint space was scored 0. A score of 2 was allowed to a focal narrowing of the joint or to a joint space not sufficiently narrowed to be scored 2. The score of 1 was not to be used when the reader was unsure whether there was joint space narrowing. A generalized narrowing leaving more than 50% of the original joint space present was scored 2. A generalized narrowing leaving less than 50% of the original joint space present was scored 3, and a subluxation of a joint was also scored 3. A bony ankylosis or a complete luxation of the joint was scored 4. A total of 13 joints were evaluated for narrowing and the scores were summed (13 x 4 [maximum per joint]). Each sum was normalized to a scale of 0 (best possible outcome) to 100 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.|||units on a scale||Standard Deviation|Mean
1251023|NCT00502853|Secondary|Joint Space Narrowing - Right Hand|Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4. A normal joint space was scored 0. A score of 2 was allowed to a focal narrowing of the joint or to a joint space not sufficiently narrowed to be scored 2. The score of 1 was not to be used when the reader was unsure whether there was joint space narrowing. A generalized narrowing leaving more than 50% of the original joint space present was scored 2. A generalized narrowing leaving less than 50% of the original joint space present was scored 3, and a subluxation of a joint was also scored 3. A bony ankylosis or a complete luxation of the joint was scored 4. A total of 13 joints were evaluated for narrowing and the scores were summed (13 times [x] 4 [maximum per joint]). Each sum was normalized to a scale of 0 (best possible outcome) to 100 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.|||units on a scale||Standard Deviation|Mean
1251024|NCT00502853|Secondary|Erosion Score - Left Hand|The erosion score per joint of the hands can range from 0 to 5. Erosions were scored 1 if they were discrete but clearly present, and 2 or 3 if they were larger, depending on the surface area of the joint involved. A score of 3 was given if the erosion was large and extended over the imaginary middle of the bone. A score of 5 was given if a complete collapse of the joint was present or if the full surface of the joint was affected. In each joint, individual erosions were summed up to a maximum of 5. The maximal erosion score for each hand was thus 80, considering the 16 areas for erosions per hand.|Baseline and Week 24|Safety Population; n=number of participants with values for analysis at the specified timepoints.|||units on a scale||Standard Deviation|Mean
1251025|NCT00502853|Secondary|Erosion Score - Right Hand|The erosion score per joint of the hands can range from 0 to 5. Erosions were scored 1 if they were discrete but clearly present, and 2 or 3 if they were larger, depending on the surface area of the joint involved. A score of 3 was given if the erosion was large and extended over the imaginary middle of the bone. A score of 5 was given if a complete collapse of the joint was present or if the full surface of the joint was affected. In each joint, individual erosions were summed up to a maximum of 5. The maximal erosion score for each hand was thus 80, considering the 16 areas for erosions per hand.|Baseline and Week 24|Safety Population|||units on a scale||Standard Deviation|Mean
1251026|NCT00502853|Secondary|Percentage of Total B-lymphocytes|Concentration of all B-lymphocytes subtypes was assessed.|Baseline and Weeks 4, 12, and 24|Safety Population|||percentage of cells||Standard Deviation|Mean
1251027|NCT00502853|Secondary|Hematocrit Concentration (%)||Baseline and Weeks 4, 12, and 24|Safety Population|||percentage||Standard Deviation|Mean
1251028|NCT00502853|Secondary|Total Immunoglobulin (Ig) Concentrations|Total Ig concentrations as measured by milligrams per milliliter (mg/mL).|Baseline and Weeks 4, 12, and 24|Safety Population|||mg/mL||Standard Deviation|Mean
1251029|NCT00502853|Secondary|Rheumatoid Factor (RF) Immunoglobulin M (IgM) Concentrations|RF IgM concentrations measured by international units per milliliter (IU/mL). RF is an antibody reacting against the fragment, crystallizable (Fc) region of IgG. Quantitative measurements have shown a prognostic value in distinguishing between progressive and non-progressive disease in early RA, a correlation with radiologically determined joint damage, and relation with clinical improvement after disease-modifying anti-rheumatic treatment.|Baseline and Weeks 4, 12, and 24|Safety Population|||IU/mL||Standard Deviation|Mean
1251030|NCT00502853|Secondary|Anti-Cyclic Citrullinated Peptide (Anti-CCP) Autoantibodies Count|Anti-CCP autoantibodies count measured by units per milliliter (U/mL). The anti-CCP autoantibodies bind antigenic determinants that contain the unusual amino acid citrulline. The anti-CCP antibody is a highly specific diagnostic test of RA (though with variable sensitivity) and a marker of joint damage with high prognostic significance.|Baseline and Weeks 4, 12, and 24|Safety Population|||U/mL||Standard Deviation|Mean
1251031|NCT00502853|Secondary|C-Reactive Protein (CRP)|CRP measured by milligrams per deciliter (mg/dL). High levels of CRP are indicators of active inflammation.|Baseline and Weeks 4, 12, and 24|Safety Population|||mg/dL||Standard Deviation|Mean
1251032|NCT00502853|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR was determined using the Westergren method. ESR measures how fast red blood cells (erythrocytes) fall to the bottom of a fine glass tube that is filled with the participant's blood. The higher the sedimentation rate the greater the inflammation.|Baseline and Weeks 4, 12, and 24|Safety Population|||mm/hr||Standard Deviation|Mean
1251033|NCT00502853|Secondary|DAS28 Score|DAS28 calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (≤) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 4, 12, and 24|Safety Population|||units on a scale||Standard Deviation|Mean
1251034|NCT00502853|Secondary|Patient’s Global Assessment of Pain|The participant’s assessment of their current level of pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line was described as “no pain” and the right-hand as “unbearable pain”. The participant was asked to mark the line corresponding to their current level of pain and the distance from the left edge was recorded.|Baseline and Weeks 4, 12, and 24|Safety Population|||mm||Standard Deviation|Mean
1251274|NCT00500370|Secondary|Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis|Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24|24 weeks|Intent to Treat population|||Participants|||Number
1251035|NCT00502853|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The Stanford HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis (RA). It consist of 20 items referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item within a domain was scored on a 4-point Likert scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The highest score reported by the participant for a domain determined the score for that domain. The overall disability index is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Weeks 4, 12, and 24|Safety Population|||units on a scale||Standard Deviation|Mean
1251036|NCT00502853|Primary|Relative Enhancement (RE) Score|A low cost, low field dedicated extremity MRI unit was used, which is specifically designed for the examination of peripheral joints. In addition to the standard OMERACT-RAMRIS scoring system, additional data were elaborated by using “dynamic” MRI (DCE-MRI). This method evaluates the diffusion of the contrast mean in a series of very short sequences thus providing a diffusion curve which is proportionate to the extent of inflammation in the synovial membrane. Numerical parameters used with this method are the slope in the initial phase (REE) and its “steady state” condition (RE).|Baseline, Weeks 4 and 24|Safety Population|||percent||Standard Deviation|Mean
1251037|NCT00502853|Primary|Early Enhancement Rate (REE)|A low cost, low field dedicated extremity MRI unit was used, which is specifically designed for the examination of peripheral joints. In addition to the standard OMERACT-RAMRIS scoring system, additional data were elaborated by using “dynamic” MRI, i.e. Contrast-Enhanced Dynamic MRI (DCE-MRI). This method evaluates the diffusion of the contrast mean in a series of very short sequences thus providing a diffusion curve which is proportionate to the extent of inflammation in the synovial membrane. Numerical parameters used with this method are the slope in the initial phase (rate of early enhancement - REE) and its “steady state” condition (relative enhancement - RE). REE per second during the first 55 seconds was calculated according to the formula REE55 = (S55-S0)/(S0x55)x100%. The REE shows the slope of the curve of contrast uptake tangential to the α angle and is steeper if inflammation is higher.|Baseline, Weeks 4 and 24|Safety Population|||percent per second||Standard Deviation|Mean
1251038|NCT00502853|Secondary|Ritchie Articular Index Scores|The Ritchie Articular Index is a graded assessment of tenderness in 26 joint regions. The sum of the grades of tenderness (0=not tender, 1=tender, 2=tender and causes wince, and 3 tender, causes wince and effort to withdraw) elicited by applying firm pressure over the joint margin of articular joints (such as shoulders, elbow, wrists, hips). The scores ranged from 0 (no tenderness) to 78 (most severe tenderness).|Baseline and Weeks 4, 12, and 24|Safety Population|||units on a scale||Standard Deviation|Mean
1251039|NCT00502853|Primary|OMERACT RAMRIS Erosion Score|MRI bone erosion measures a sharply marginated bone lesion, with correct juxta-articular localization and typical signal characteristics, which is visible in 2 planes with a cortical break seen in at least 1 plane. Each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) scored separately. Scale is 0–10 based on proportion of eroded bone compared to assessed bone volume (0=no erosion; 1=1%–10% of bone eroded; 2=11%–20%, etc). For long bones, assessed bone volume is from articular surface (or best estimated position if absent) to depth of 1 centimeter (cm); in carpal bones it is the whole bone. Total erosion score=sum of individual scores for an overall range of 0–230, where 0=no erosion and 230=most severe erosion. Change in erosion=Follow-up erosion score - baseline score.|Baseline, Week 4, and Week 24|Safety Population|||units on a scale||Standard Deviation|Mean
1251040|NCT00502853|Primary|OMERACT RAMRIS Bone Edema Score|Extension and degree of bone edema in the wrist according to the RAMRIS score developed by OMERACT. Bone edema is a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) is scored separately. The scale of 0–3 was based on the proportion of bone with edema, as follows: 0=no edema; 1=1 percent (%) to 33% of bone was edematous; 2 = 34%–66% of bone was edematous; and 3= 67%–100% of bone was edematous. Total bone edema score=sum of the individual scores for an overall range of 0–69, where 0=no edema and 69=most severe edema. Change in bone edema = follow-up bone edema score - baseline score.|Baseline, Weeks 4 and 24|Safety Population|||units on a scale||Standard Deviation|Mean
1251041|NCT00502853|Primary|Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score|Extension and degree of synovitis in wrist according to RAMRIS score developed by OMERACT. Synovitis is an area in synovial compartment that shows above normal post-gadolinium enhancement of a thickness greater than width of normal synovium. Synovitis is assessed in 3 wrist regions (distal radioulnar joint; radiocarpal joint; intercarpal and carpometacarpal joints) and in each metacarpophalangeal (MCP) joint. 1st carpometacarpal joint and 1st MCP joint are not scored. Score 0 is normal, and 1–3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score=the sum of the individual scores (3 wrist regions [range 0-9] or 4 MCP joints [range 0-12]) for an overall range of 0–21, where 0=no damage and maximum score [9, 12, or 21]=most severe damage. Change in synovitis = Follow-up synovitis score - baseline score.|Baseline, Week 4, and Week 24|The Safety Population included all participants who received any portion of the rituximab dose and was used for efficacy and safety analyses.|||units on a scale||Standard Deviation|Mean
1251042|NCT00502840|Secondary|Rheumatoid Factor (RF)|RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||IU/mL||Standard Deviation|Mean
1251043|NCT00502840|Secondary|Erythrocyte Sedimentation Rate|ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
1255323|NCT00467363|Secondary|hCG Recognized Pregnancy||within 8-weeks of gestation||||pregnancy|||Number
1251044|NCT00502840|Secondary|C-Reactive Protein|CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1251045|NCT00502840|Secondary|Patient's Assessment of Pain|"Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as unbearable pain."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1251046|NCT00502840|Secondary|Patient's Global Assessment of Disease Activity|"Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1251047|NCT00502840|Secondary|Physician's Global Assessment of Disease Activity|"Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1251048|NCT00502840|Secondary|Tender Joint Count|Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
1251049|NCT00502840|Secondary|Swollen Joint Count|Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
1251050|NCT00502840|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course|ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit.|24 weeks after each course|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1251051|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - General Heath Perceptions|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251052|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Vitality|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1254572|NCT00473083|Secondary|Time to First Presentation of Rash||Up to onset of rash while on study treatment|Subjects with maximum severity of rash of grade 1, 2a, 2b and 3|||days||Standard Deviation|Mean
1251053|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Social Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251054|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Emotional Well-Being|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251055|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Emotional Role Functioning|SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251056|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Physical Role Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251057|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Bodily Pain|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251058|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Physical Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251066|NCT00502840|Primary|Change From Baseline in DAS28 Score at Week 24|DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units.|Week 24|Intent-to-Treat (ITT) Population: all participants who signed the informed consent form, received at least 1 dose of study medication, and where the DAS28 was measured at least once under study medication.|||scores on a scale||Standard Deviation|Mean
1251059|NCT00502840|Secondary|SF-36 MCS by Treatment Course|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251060|NCT00502840|Secondary|Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251061|NCT00502840|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course|FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251062|NCT00502840|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course|HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1251063|NCT00502840|Secondary|Percentage of Participants Achieving a Response By EULAR Category and Treatment Course|Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score > 5.1.|Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1251064|NCT00502840|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course|DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.|Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1251065|NCT00502840|Secondary|DAS28 Score by Treatment Course and Follow-up (FU) Visit|DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1254573|NCT00473083|Secondary|Duration of Treatment||Up to one year||||months||95% Confidence Interval|Median
1251067|NCT00502801|Secondary|Clinical Response Rates at the Late Follow-up Assessment.|"The table below shows the percentage of subjects who had a clinical response of “clinical cure” at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of clinical cure is defined as no further antibacterial therapy needed for treatment of the infection."|28 to 35 days after last dose of study therapy|Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.|||Percentage of participants|||Number
1251068|NCT00502801|Primary|Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.|The table below shows the percentage of subjects who had a clinical response of “clinical cure” at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of “clinical cure” is defined as no further antibacterial therapy needed for treatment of the infection.|5 to 21 days after the last dose of study therapy, or at early termination.|Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.|||Percentage of participants||95% Confidence Interval|Number
1251069|NCT00502775|Secondary|Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)|Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.|Baseline, Day 15 or if Early Withdrawal Day|Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects had no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score, or both. One additional FFNS patient had no on-treatment NRQLQ data.|||Score on a Scale||Standard Error|Mean
1251070|NCT00502775|Secondary|Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)|Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.|Baseline and Weeks 1-2|Two subjects in the placebo group & two in the FFNS group recorded no data during the two-week treatment period.|||Score on a Scale||Standard Error|Mean
1251071|NCT00502775|Secondary|Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)|Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.|Baseline and Weeks 1-2|Two subjects in the placebo group & three in the FFNS group recorded no data during the two-week treatment period.|||Score on a Scale||Standard Error|Mean
1251072|NCT00502775|Secondary|Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
1251073|NCT00502775|Secondary|Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
1251074|NCT00502775|Secondary|Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
1251075|NCT00502775|Secondary|Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
1251076|NCT00502775|Secondary|Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
1251077|NCT00502775|Secondary|Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
1251078|NCT00502775|Secondary|Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
1251079|NCT00502775|Secondary|Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
1251080|NCT00502775|Primary|Mean Change From Baseline in the Nighttime Symptom Score (NSS)|Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.|Baseline and Weeks 1-2|One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.|||Score on a Scale||Standard Error|Mean
1251081|NCT00502697|Secondary|Maternal Length of Stay at Delivery|Number of maternal hospital days associated with delivery|Hospital discharge point following delivery|Of the 211 participants, data on length of stay at delivery were available for 194 women. The most common reason for the lack of this information was that the birth did not take place at the study’s medical center.|||days||Full Range|Median
1251082|NCT00502697|Primary|Infant Gestational Age|Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.|Time of delivery|ITT analysis used with all participants that birth information could be obtained.|||weeks||Inter-Quartile Range|Median
1251083|NCT00502671|Secondary|Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE|The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.|Up to 25 weeks (from Baseline to the end of safety follow-up)|Safety Population.|||percentage of participants|||Number
1251084|NCT00502671|Primary|Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE|The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.|Up to 25 weeks (from Baseline to the end of safety follow-up)|Safety Population.|||percentage of participants|||Number
1251085|NCT00502593|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|AESIs are adverse events such as clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. AESIs assessed included neuroinflammatory disorders such as cranial nerve disorders, multiple sclerosis,transverse myelitis, Guillain-Barré syndromeor neuritis), musculoskeletal disorders (such as systemic lupus erythematosus, cutaneous lupus, polymyositis, rheumatoid arthritis, reactive arthritis, psoriatic arthropathy, or undifferentiated spondyloarthropathy), gastrointestinal disorders (such as Crohn’s disease, ulcerative colitis, ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, Addison’s disease). skin disorders (such as psoriasis, vitiligo, Raynaud’s phenomenon, or autoimmune bullous skin diseases), and other conditions as autoimmune hemolytic anemia, thrombocytopenias, antiphospholipid syndrome, vasculitis, autoimmune hepatitis, or sarcoidosis.|Throughout the entire study period, from Day 0 to Month 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251086|NCT00502593|Secondary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response|A seroconverted subject as regards to neutralizing antibody response was a subject with a minimum 4-fold increase in neutralizing antibody titer at post-vaccination. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.|At Months 6, 12 and 24.|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
1251087|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.|At Months 6, 12 and 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Titer||95% Confidence Interval|Geometric Mean
1251088|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase C of the study.|At Days 21 and 42|The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.|||Participants|||Count of Participants
1254574|NCT00473083|Secondary|Overall Survival||Until death||||months||95% Confidence Interval|Median
1280666|NCT00263887|Secondary|Duration and Severity of the Exacerbations||24 or 30 months|||||||
1251089|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase B of the study.|At Days 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Participants|||Count of Participants
1251090|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase A of the study.|At Days 21 and 42|The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.|||Participants|||Count of Participants
1251091|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase C of the study.|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1251092|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase B of the study.|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1251093|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET).Results presented are for subjects participating in Phase A of the study|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1251094|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251095|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251096|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251097|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Participants|||Count of Participants
1251571|NCT00497146|Secondary|Change in Plasma Triiodothyronine (T3)|Plasma triiodothyronine (T3) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||nanomoles/liter||Standard Error|Least Squares Mean
1251098|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251099|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251100|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251101|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251102|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251103|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.|At Days 0, 21 and 42 and at Month 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251104|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251105|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251106|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251161|NCT00502320|Primary|Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)|Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.|||scores on a scale||Standard Error|Mean
1251107|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251108|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251109|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251110|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251111|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251112|NCT00502593|Primary|Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251113|NCT00502593|Primary|Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251114|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251137|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
1251115|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C|Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251116|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251117|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251118|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251119|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251120|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251121|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251138|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
1251122|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251123|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251124|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251125|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251126|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251127|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251128|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251139|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
1251129|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A|Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251130|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination."|During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251131|NCT00502593|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.|During the entire study (Day 0 to Month 24)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251132|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.|During the 7-day follow-up period after each vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251133|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251134|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature > 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
1251135|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.|During the 7-day follow-up period after each vaccination|The analysis was based on theTotal Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251136|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.|During the 7 day follow-up period after each vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1251160|NCT00502320|Secondary|Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)|Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.|||scores on a scale||Standard Error|Mean
1284556|NCT00204932|Primary|Fat Mass|loss of fat mass, kg|6 months||||kg||Standard Deviation|Mean
1251140|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1251141|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1251142|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 0|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1251143|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Fold||95% Confidence Interval|Geometric Mean
1251144|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Fold||95% Confidence Interval|Geometric Mean
1251145|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Fold||95% Confidence Interval|Geometric Mean
1251146|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold||95% Confidence Interval|Geometric Mean
1251147|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Fold||95% Confidence Interval|Geometric Mean
1251148|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
1251149|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
1251202|NCT00501891|Secondary|Incidence and Severity of CNS Hemorrhage and Systemic Hemorrhage|Number of participants experiencing a Central Nervous System (CNS) hemorrhage or systemic hemorrhage|27 months|Intent to treat|||participants|||Number
1251150|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
1251151|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1251152|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1251153|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Titer||95% Confidence Interval|Geometric Mean
1251154|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Titer||95% Confidence Interval|Geometric Mean
1251155|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Titer||95% Confidence Interval|Geometric Mean
1251156|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Titer||95% Confidence Interval|Geometric Mean
1251157|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Titer||95% Confidence Interval|Geometric Mean
1251158|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.|At Day 0|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1251159|NCT00502320|Secondary|Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)|Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.|||scores on a scale||Standard Error|Mean
1251218|NCT00501293|Primary|Post Sleep Questionnaire (PSQ) Quality of Sleep|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|6 months|Safety Population|||Participants|||Number
1251162|NCT00502242|Secondary|Percentage of Participants With Hyperkalemia|Hyperkalemia defined as serum potassium >5.6 millimoles per liter (mmol/L)|Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1251163|NCT00502242|Secondary|Percentage of Participants With Malignancy|Includes treatment-emergent adverse events based on categorization by the investigator as 'malignancy', regardless of the event preferredterm in MedDRA.|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population|||percentage of participants|||Number
1251164|NCT00502242|Secondary|Percentage of Participants With Angioedema|Includes treatment-emergent adverse events based on categorization by the investigator as angioedema, regardless of the event preferred term in MedDRA.|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population|||percentage of participants|||Number
1251165|NCT00502242|Secondary|Percentage of Participants With an Infection|Includes treatment-emergent adverse events based on categorization by the investigator as 'infection', regardless of the event preferred term in Medical Dictionary for Regulatory Activities (MedDRA.)|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population|||percentage of participants|||Number
1251166|NCT00502242|Secondary|Percentage of Participants Using Statins||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of participants|||Number
1251167|NCT00502242|Secondary|Percentage of Participants With Graft Loss at 24 and 52 Weeks Following Conversion to SRL|Graft loss was defined as physical loss (nephrectomy orretransplantation), functional loss (requiring dialysis for ≥56days with no return of graft function), or death.|24 weeks and 52 weeks after conversion|mITT population|||percentage of participants|||Number
1251168|NCT00502242|Secondary|Number of Participants With BCAR by Severity of First BCAR|Severity was summarized by type (antibody versus T-cell) and by phase: post-SRL (where both on-therapy and off-therapy events are included) and post-SRL (on-therapy). BCAR was categorized using Banff criteria as antibody-mediated (AM) or T-cell. AM BCAR severity was graded as Grade I (mild), Grade II (moderate [mod]), and Grade III (severe). T-cell BCAR severity was graded as 'Grade Ia, Ib (mild), Grade IIa, IIb (mod), and Grade III (severe). If a participant had both T-cell BCAR and antibody-mediated BCAR on the first rejection, the participant was counted in each category. For participants with T-cell BCAR (post-SRL and post-SRL On -Therapy) the p-value could not be calculated and all events were mild in severity.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population; only participants with BCAR were included in the anlaysis.|||participants|||Number
1251169|NCT00502242|Secondary|Percentage of Participants With First BCAR at 24 and 52 Weeks Following Conversion to SRL|BCAR was defined according to updated Banff criteria (1997)for renal allograft rejection. Participants without BCAR were censored at the time of withdrawal from the study. Defined as the first BCAR occurring on therapy following conversion to SRL based on the mITT population. Time to first BCAR was defined as the date of first BCAR to date of the first dose of SRL (in weeks). Percentages were estimated using the Kaplan-Meier method for time to event data.|24 weeks and 52 weeks after conversion|mITT population; includes BCAR occurring in the On-Therapy and Off-Therapy Periods|||percentage of participants||95% Confidence Interval|Number
1251170|NCT00502242|Secondary|Biopsy-Confirmed Acute Rejection (BCAR) - Number of Participants With an Event|BCAR was defined according to updated Banff criteria (1997)for renal allograft rejection. The time to the first BCAR was defined as the date of first BCAR to the date of the first dose of SRL (in weeks). Participants without BCAR were censored at the time of withdrawal from the study.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population; includes BCAR occurring in On-Therapy and Off-Therapy Periods.|||participants|||Number
1251171|NCT00502242|Secondary|Change From Baseline in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L]) at 4, 12, 24, and 52 Weeks Following Conversion to SRL|Parameters assessed included (all fasting) total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high-densitylipoprotein cholesterol (HDL-C).|4, 12, 24, and 52 weeks after conversion|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mmol/L||Standard Error|Mean
1251172|NCT00502242|Secondary|Percentage of Participants Using Red Blood Cell Production Stimulants (Erythropoiesis Stimulating Agents [ESAs])||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of participants|||Number
1251173|NCT00502242|Secondary|Percentage of Participants With Hemoglobin Levels ≤100 Grams Per Liter (g/L)||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population|||percentage of participants|||Number
1251174|NCT00502242|Secondary|SRL Time-Normalized Trough Concentration (Cmin,TN) by Time Interval|Cmin,TN was determined for SRL using the area method for the intervals: 0–2 weeks, >2–4 weeks, >4–12 weeks, >12–24 weeks, >24–36 weeks and >36–52 weeks using the equation:Cmin,TN = AUCi-j/timej-timeiwhere AUC is the area under the concentration-time curve, i is the beginning of the interval and j is the end of the interval. Cmin,TN was calculated for participants who did not dropout of studies, but were missing concentrations at the interval endpoints by carrying the last observed concentration forward to the interval endpoint.|From Day 1 of SRL conversion to 52 weeks after conversion|Safety population; n=number of participants assessed for the specified parameter for the given time interval; only participants dosed throughout the interval were included.|||ng/mL||Standard Deviation|Mean
1251175|NCT00502242|Secondary|Percentage of Participants With Potentially Clinically Important Blood Pressure (BP) Values by Diastolic and Systolic BP Category|BP values of potential clinical importance were recorded and categorized as follows: diastolic BP (DBP) ≤50 millimeters of mercury (mmHg) or ≥110 mmHg and systolic BP (SBP) ≤90 mmHg and ≥180 mmHg. Data were summarized for the on-therapy period and the off-therapy period and for the pre-SRL period.|Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population|||percentage of participants|||Number
1251176|NCT00502242|Secondary|Fraction of Albumin (Milligrams Per Deciliter [mg/dL]) to Protein (mg/dL) in Urine at 24 and 52 Weeks After Conversion to SRL|Baseline fraction was the last value of the pre-SRL conversion period. Only the last value of U p/c or U alb/c was used for analysis if multiple measurements occurred in the same data anlysis interval. Fraction of albumin and protein was calculated only when urine protein was 6.2 mg/dL or higher. For urine albumin, if the value was reported as '<xx.x', the numerical portion of the value was used in the calculation of fraction of albumin and protein.|24 weeks and 52 weeks after conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit. Includes measures collected from On-Therapy and Off-Therapy Periods.|||(mg/dL)/(mg/dL)||Standard Deviation|Mean
1251177|NCT00502242|Secondary|Abbreviated Modified Diet in Renal Disease (MDRD) Glomerular Filtration Rate (GFR) at Weeks 12, 24, and 52 Following Conversion to SRL|Calculated in millimeters per minute per 1.73 square meters (mL/min/1.73m^2). Age and corresponding creatinine at each visit (Weeks 12, 24, and 52) were used to calculate GFR.|12, 24, and 52 weeks following conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit. Includes measures collected from On-Therapy and Off-Therapy Periods.|||mL/min/1.73 m^2||Standard Deviation|Mean
1251178|NCT00502242|Secondary|Percentage of Participants Who Discontinued SRL Therapy at 24 and 52 Weeks Following Conversion to SRL|Defined as the percentage of participants who stop SRL (as test article) between the first day of SRL and either Week 24 or Week 52 following conversion to SRL. If a participant had a >14 day gap in SRL use, the stop date of SRL was the date of the last SRL use before it was re-initiated. Participants who early terminate SRL at Week 24 were defined as having SRL stop day less than or equal to (≤) Day 190 (selected as the midpoint between Weeks 24 and 30). Participants who early terminate SRL at Week 52 were defined as having SRL stop day ≤Day 337 (selected as the midpoint between Weeks 44 and 52).|24 weeks and 52 weeks after conversion|mITT population|||percentage of participants|||Number
1251179|NCT00502242|Secondary|U Alb/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL|U alb/c was measured in mg/mg. Baseline U alb/c values were the last values of the pre-SRL conversion period.|Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit; only participants with nonmissing records of U alb/c were included in the analysis. Includes measures collected from On-Therapy and Off-Therapy Periods.|||mg/mg||Standard Deviation|Mean
1251180|NCT00502242|Secondary|U p/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL|U p/c was measured in milligrams per milligram (mg/mg). The baseline U p/c values were the last values of the pre-SRL conversion period.|Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion|mITT population; n (number) = number of participants assessed for the specified parameter at a given visit; only participants with nonmissing records of U p/c were included in the analysis. Includes measures collected from On-Therapy and Off-Therapy Periods.|||mg/mg||Standard Deviation|Mean
1251181|NCT00502242|Secondary|Percentage of Participants With Both U Alb/c <0.5 and U p/c <0.5 at 24 and 52 Weeks Following Conversion to SRL|The U alb/c and U p/c must have been collected on the same day to be counted as the numerator.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.|||percentage of participants|||Number
1251182|NCT00502242|Secondary|Percentage of Participants With Urinary Albumin to Creatinine Ratio (U Alb/c) <0.5 at 24 and 52 Weeks Following Conversion to SRL|Spot urine sample of albumin and creatinine concentrations were obtained during the pre-SRL conversion period and after conversion.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.|||percentage of participants|||Number
1251183|NCT00502242|Secondary|Percentage of Participants With U p/c <0.5 at 24 and 52 Weeks Following Conversion to Sirolimus|Spot urine sample of protein and creatinine concentrations were obtained during the pre-SRL conversion period and after conversion.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.|||percentage of participants|||Number
1251184|NCT00502242|Secondary|Percentage of Participants Who Had a Dose Escalation in Randomized Test Article (Ramipril or Placebo) by 52 Weeks Following Conversion to SRL|Defined as the time from the first dose of SRL administration to the first dose escalation of randomized test article (ramipril or placebo; in weeks), or censored on the day that a participant stopped the combination of SRL and randomized test article (ramipril or placebo) if the participants did not experience any ramipril/placebo dose escalation following conversion to SRL. Dose-escalation was defined as an increase in total daily dose of ramipril/placebo compared to Day 1 post conversion. Percentage was estimated using Kaplan-Meier method for time to event data.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population|||percentage of participants||95% Confidence Interval|Number
1251185|NCT00502242|Primary|Percentage of Participants Who Had Initiated Losartan Therapy at 52 Weeks Following Conversion to SRL|The event for each participant was defined as the initiation of losartan while on SRL and ramipril/placebo combination therapy. Participants who started losartan prior to SRL administration were not counted as events. Percentage was estimated using Kaplan-Meier method for time to event data.|From Day 1 of SRL conversion to 52 weeks after conversion|Modified Intent to Treat (mITT) population: all participants in the safety population who took at least one dose of SRL.|||percentage of participants||95% Confidence Interval|Number
1251186|NCT00502216|Secondary|Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline|Tolerability was measured by tracking adverse events. These data are reported in detail in the adverse events section. Presented are an unduplicated count of participants that experienced at least 1 adverse event.|11 weeks||||Participants|||Count of Participants
1251187|NCT00502216|Secondary|Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment||4 weeks|Analyzed are those that remained abstinent for last 4 weeks of treatment|||pounds||Standard Deviation|Mean
1251188|NCT00502216|Primary|Weight Gain in Treatment Completers||baseline and 12 weeks|Subpopulation of participants who reported quitting smoking|||Pounds||Standard Deviation|Mean
1251219|NCT00501293|Primary|Electrocardiogram Results (QTcF Interval)|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and 6 months|Safety Population|||msec||Standard Deviation|Mean
1251189|NCT00502203|Primary|Number of Participants With Overall Response|Overall response rate including complete (CR) and partial responses (PR) with measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) assessment. CR: Disappearance of all target and non-target lesions; no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. PR: At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD; no unequivocal progression of non-target lesions and no new lesions. Documentation by 2 disease assessments at least 4 weeks apart is required.|24 Months|Thirteen participants had measurable disease therefore evaluable for a complete or partial response.|||participants|||Number
1251190|NCT00501995|Secondary|Change in the HAQ-DI, PGA, FVC and DLCO|The Health Assessment Questionnaire-Disability Index (HAQ-DI) a 48 item questionnaire assessing ability to perform activities of daily living, use of assistive devises and a 6 item analog scale of pain severity from 0 cm (no pain) to 14.3 cm (very severe pain). The lower the HAQ-DI score the less the disability. The physician global assessment (PGA) which is a visual analogue scale from 0 to 100 on which the physician rates the patient's disease severity based on their observations. A score of 0 is no disease activity and 100 is the worst possible disease activity. The Forced Vital Capacity (FVC) measure of lung capacity and Diffusing Capacity (DLCO) measures of oxygen exchange in the alveoli ( pulmonary function testing). The predicted lung volumes were referenced from NHANES/Hanikson et al and for DLCO predicts were from Knudson. Pre and post study percent predicted values were compared.|0-24 months|The study group consisted of 4 men and 2 women aged 19-60 years of old.|||percentage change||Full Range|Mean
1251191|NCT00501995|Primary|Improvement in the Modified Rodnan Skin Score.|The modified Rodnan skin score is the accepted clinical measure of scleroderma skin activity. The investigator will assess the thickening of the skin using the modified Rodnan skin score through simple palpation on 17 different body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness is assessed on a scale of 0-3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0-51; 0 (normal) to 51 (severe thickening in all 17 areas) A 25% improvement in the modified Rodnan Skin score will be considered significant at any time point in the study. Modified Rodnan Skin Score was evaluated at months 0,1,3,6,12 and 24 months.|0 to 24 months|Patient 4 died during the early phase of the study and longitudinal assessment of his skin score was not determined.|||percent improvement from baseline||Full Range|Mean
1251192|NCT00501969|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.|||Score on a scale||Standard Deviation|Mean
1251193|NCT00501969|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|five years|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
1251194|NCT00501969|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|five years|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
1251195|NCT00501943|Secondary|Changes in Normalized Grey Matter Volume|The baseline data of grey matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX|Baseline, Month-3, Month-6, Month-12 and Month-24||||percent change per year||95% Confidence Interval|Mean
1251196|NCT00501943|Secondary|Changes in Symbol Digit Modality Test (SDMT)|Baseline SDMT data were compared to SDMT data collected during the timepoints. A simple substitution task, the SDMT gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24||||percent change per year||95% Confidence Interval|Mean
1251197|NCT00501943|Secondary|Changes in Peripapillary Retinal Nerve Fiber Layer Thickness (RNFL)|Baseline RNFL data is compared to the RNFL data collected during the timepoint, and the changes in RNFL is measured using optical coherence tomography (OCT).|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24||||percent change per year||95% Confidence Interval|Mean
1251198|NCT00501943|Secondary|Changes in MS Functional Composite (MSFC)|Baseline MSFC data is compared to MSFC data collected during the timepoints. The MSFC is a three-part, standardized, quantitative, assessment instrument that measures the clinical dimensions of leg function, arm/hand function and cognitive function and the components include Timed 25-Foot walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test.|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24||||percent change per year||95% Confidence Interval|Mean
1251199|NCT00501943|Secondary|Changes in Normalized White Matter Volumes (nWMV)|The baseline data of white matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24||||percent change per year||95% Confidence Interval|Mean
1251200|NCT00501943|Primary|MRI Parameter- Percent Brain Volume Change for 2 Years|Baseline MRI is compared to MRI images collected during subsequent timepoints. The percent brain volume change is measured using SIENAX (Structural Image Evaluation using Normalization of Atrophy-X)|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|Multivariate regression model was used as the statistical method of analysis for the study. So data from patients who have not completed the study are also used for statistical analysis.|||percent change per year||95% Confidence Interval|Mean
1251201|NCT00501891|Secondary|Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity|Number of participants experiencing a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity|27 months|Intent to treat|||participants|||Number
1251220|NCT00501293|Primary|Pulse Rate||Baseline and 6 months|Safety population|||beats per minute||Standard Deviation|Mean
1251203|NCT00501891|Secondary|Response Rate|The number of participants with complete or partial response as determined by a modification of the Macdonald criteria. Complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|27 months|Intent to treat|||Number of participants|||Number
1251204|NCT00501891|Primary|6-Month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. [Optional: Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).]|6 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1251205|NCT00501852|Secondary|Least Squares Means of FEV1 (L) at Day 1, by Timepoint|FEV1 was measured at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23 hours and 15 minutes, and 23 hours and 45 minutes post dose.|Day 1||||Liters||Standard Error|Least Squares Mean
1251206|NCT00501852|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing.|Day 7|Modified Intent-to-Treat (mITT) population. The modified intent-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they received.|||Liters||Standard Error|Least Squares Mean
1251207|NCT00501644|Primary|Number of Patients With Response|Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as > = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by >50%, provided target lesion size did not increase by >20% on imaging, and PD as >20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or > new lesions.|Follow up CT scans after every 3 courses of treatment and following completion of all treatments.|Analysis per protocol. Of 59 participants enrolled, five (5) were not evaluable.|||Participants|||Number
1251208|NCT00501631|Secondary|Longer-term Safety of VIVITROL|Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.|up to 1 year|||||||
1251209|NCT00501631|Primary|Cumulative Percentage of Participants by Heavy Drinking Rate|"Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A heavy drinking day was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell & Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary)."|up to 12 weeks|The primary endpoint is based on percentage rate of heavy drinking days during the double-blind treatment period as per protocol.|||percentage of participants|||Number
1251210|NCT00501592|Secondary|Hepatocellular Function|Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function|baseline and 6 weeks||||U/L||Standard Deviation|Mean
1251211|NCT00501592|Primary|Insulin Resistance and Glucose Homeostasis|The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).|baseline and 6 weeks||||mg/kg/min||Standard Deviation|Mean
1251212|NCT00501540|Secondary|Overall Survival (OS)|Overall survival for a participant is defined as the number of days from the day of first Lithium administration to the participant's death. As of the time of analysis (03/10/2011), median overall survival duration was not reached.|Up to 4 years|The median OS time had not been reached.|||participants||Full Range|Median
1251213|NCT00501540|Secondary|Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival is measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression. If a participant did not experience an event of disease progression or death at the time of analysis (03/10/2011), then the patient's data was censored at the date of the last available evaluation.|Up to 4 years||||months||95% Confidence Interval|Median
1251214|NCT00501540|Primary|Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.|Up to 4 years||||participants|||Number
1251215|NCT00501345|Primary|Participants With 7 Days Observation Without Severe Bleeding|Blood samples collected at baseline before or after aspirin is given and at 24 hours, 72 hours and 7 days after treatment has been initiated for those that remain in the study after the first 24 hours.|7 Days|The baseline Thromboelastogram showed normal platelet function in all patients and no evidence of heparin induced thrombocytopenia (HIT). No further analysis was done as study was terminated due to lack of accrual.||||||
1251216|NCT00501293|Primary|Dermal Reactions|Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|6 months|Safety Population|||Participants|||Number
1251217|NCT00501293|Primary|Weight||Baseline and 6 months|Safety population|||lb||Standard Deviation|Mean
1251223|NCT00501293|Secondary|Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 6 months|ITT. Not all subjects in the ITT population completed a YQOL-R.|||Units on a scale||Standard Deviation|Mean
1251224|NCT00501293|Secondary|Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 months|ITT|||Participants|||Number
1251225|NCT00501293|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 months|ITT|||Participants|||Number
1251226|NCT00501293|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 months|ITT|||Units on a scale||Standard Deviation|Mean
1251227|NCT00501293|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 months|Intent-to-treat (ITT) defined as subjects who were enrolled and received at least one dose of MTS and had at least one assessment of the primary efficacy endpoint.|||Units on a scale||Standard Deviation|Mean
1251228|NCT00501228|Primary|Number of Donor Derived Cells After G-CSF Therapy|In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.|Baseline + 8 Weeks post transplant|No analysis was done. Only one eligible patient was able to complete treatment.||||||
1251229|NCT00501085|Secondary|Subject Reported Sleepiness (Epworth Sleepiness Scale)|The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject’s level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).|Baseline to 5 years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||units on a scale||Standard Deviation|Mean
1251230|NCT00501085|Secondary|Subject Reported Quality of Life|Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||units on a scale||Standard Deviation|Mean
1251231|NCT00501085|Secondary|Subject Reported Satiety|Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||units on a scale||Standard Deviation|Mean
1251232|NCT00501085|Secondary|Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation|Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.|Baseline to 5 years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||kg/m2||Standard Deviation|Mean
1251233|NCT00501085|Primary|Change in Percent Excess Weight|Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||percentage of excess weight lost||Standard Deviation|Mean
1251234|NCT00501059|Other Pre-specified|Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population|*all other CV death without fatal MI and fatal stroke.|Until follow-up (approximate 6 years)|Per-protocol (PP) group (N=7702) consists of all patients who had no protocol violation.|||Percentage of participants|||Number
1251235|NCT00501059|Other Pre-specified|Incidence of Composite Outcomes and Non-fatal MI||Until follow-up (approximate 6 years)|ITT|||Percentage of participants|||Number
1251236|NCT00501059|Other Pre-specified|Number of Subjects With Adjudicated GI Bleeding by Severity||Until follow-up (approximate 6 years)|ITT|||Participants|||Count of Participants
1251237|NCT00501059|Secondary|Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately|The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. *all other CV death without fatal MI and fatal stroke|Until follow-up (approximately 6 years)|ITT|||Percentage of participants|||Number
1251238|NCT00501059|Secondary|Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer||Until follow-up (approximately 6 years)|ITT|||Percentage of participants|||Number
1251239|NCT00501059|Secondary|Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer|The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.|Until follow-up (approximately 6 years)|ITT|||Days|Days||Count of Units
1251572|NCT00497146|Secondary|Change in Left Atrial Volume|Left atrial volume is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters||Standard Error|Least Squares Mean
1251240|NCT00501059|Secondary|Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA|The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.|Until follow-up (approximately 6 years)|ITT|||Days|Days||Count of Units
1251241|NCT00501059|Secondary|Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)|The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.|Until follow-up (approximate 6 years)|ITT|||Days|Days||Count of Units
1251242|NCT00501059|Primary|Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)|The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.|Until follow-up (approximate 6 years)|Intention-to-treat. The intent-to-treat (ITT) group (N=12546) consists of all patients who were randomized to the assigned study drug.|||Days|Days||Count of Units
1251243|NCT00501046|Secondary|Vitamins and Folate Levels||approximately 42 months|||||||
1251244|NCT00501046|Secondary|The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function and (QOL: Exploratory)||approximately 42 months|||||||
1251245|NCT00501046|Primary|Safety and Tolerability||approximately 42 months|||||||
1251246|NCT00501046|Primary|Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.||Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|ITT (censored at last contact)|||participants|||Number
1251247|NCT00501007|Secondary|Persistence as a Prospective Predictor of Smoking Cessation|Analysis of Generalized Estimating Equations (GEE) parameter estimates based on empirical standard error estimates, using an exchangeable working correlation structure, with smoking abstinence as outcome variable, and task persistence, time, diagnosis, ability, Fagerstrom Test for Nicotine Dependence (FTND) score, and the interaction between disorder and persistence as explanatory variables.|6 months||||Odds ratio||95% Confidence Interval|Number
1251248|NCT00501007|Primary|Mirror-tracing Persistence (in Seconds)|Number of seconds participants continued working on a mirror tracing task before giving up.|baseline|All meeting inclusion criteria|||seconds||Standard Deviation|Mean
1251249|NCT00500760|Secondary|Percentage of Participants With a Complete Response at 6 Months|Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.|6 months|Evaluable for Central Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
1251250|NCT00500760|Secondary|Percentage of Participants With an Objective Response at 6 Months|"Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months.~Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions."|6 months|Evaluable for Central Tumor Response Analysis Set: the subset of participants in the Efficacy Analysis Set with at least one bi-dimensionally measurable lesion at baseline using a modified version of the WHO criteria per blinded central review.|||percentage of participants||95% Confidence Interval|Number
1251251|NCT00500760|Secondary|Overall Survival|Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.|From first dose date up to 37 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
1251252|NCT00500760|Secondary|Progression-Free Survival|"Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death.~Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions.~Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date."|From first dose date to 37 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
1251253|NCT00500760|Secondary|Duration of Local-regional Control|Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.|From first dose up to 37 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
1251254|NCT00500760|Secondary|Local Regional Control Rate at 6 Months and 12 Months|Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.|6 months and 12 months|Efficacy Analysis Set|||proportion of paticipants||95% Confidence Interval|Number
1251255|NCT00500760|Primary|Local Regional Control Rate at 2 Years|In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.|2 years|Efficacy Analysis Set (all randomized participants who received at least 1 dose of protocol-specified treatment according to treatment randomization regardless of treatment received.)|||proportion of paticipants||95% Confidence Interval|Number
1251256|NCT00500682|Secondary|Vitamins and Folate Levels||approximately 42 months|||||||
1251257|NCT00500682|Secondary|The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function||approximately 42 months|||||||
1251258|NCT00500682|Primary|Safety and Tolerability||approximately 42 months|||||||
1251259|NCT00500682|Primary|Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.||Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|ITT (censored at last contact)|||participants|||Number
1251260|NCT00500656|Secondary|Time to Almost Complete Symptom Relief|Almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least three consecutive measurements for all symptoms.|48 hours||||Hours||Inter-Quartile Range|Median
1251261|NCT00500656|Primary|Time to Onset of Symptom Relief.|"The primary efficacy endpoint was Time to onset of symptom relief (TOSR) following treatment with either icatibant or tranexamic acid. The median time to onset of symptom relief for the icatibant group was compared to the the median time to onset of symptom relief for the tranexamic acid group.~TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the three primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.~The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe."|2 days||||Hours||Inter-Quartile Range|Median
1251262|NCT00500578|Primary|Occurrences of Pneumonia|Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint.|6 Years|The analysis was carried out per protocol. All patients enrolled were included in the final analysis except one patient who was a screen failure.|||Participants|||Number
1251263|NCT00500539|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period|The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).|Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)|The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.|||participants|||Number
1251264|NCT00500539|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period|The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.|24 weeks treatment period + 4 weeks for following up participants|The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.|||participants|||Number
1251265|NCT00500539|Primary|The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period|An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.|16 weeks after last dose|The Safety Population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. The analysis was done on total number of patients who had follow-up HAHA sample taken.|||participants|||Number
1251266|NCT00500448|Primary|Change From Baseline in Quadriceps Strength at 12 Weeks||Baseline and 12 weeks following the intervention||||Nm/kg||95% Confidence Interval|Mean
1251267|NCT00500448|Secondary|Change From Baseline in WOMAC Pain Score at 12 Weeks|WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain)|Baseline and 12 weeks following intervention||||units on a scale||95% Confidence Interval|Mean
1251268|NCT00500448|Secondary|Change From Baseline in Timed Walking Speed at 12 Weeks||Baseline and 12 weeks post-intervention||||m/s||95% Confidence Interval|Mean
1251269|NCT00500448|Secondary|Change From Baseline in WOMAC Disability Score at 12 Weeks|Womac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss)|baseline and 12 weeks post-intervention||||units on a scale||95% Confidence Interval|Mean
1251270|NCT00500448|Primary|Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks|Knee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus|Baseline and 12 weeks post-intervention||||unitless||95% Confidence Interval|Mean
1261103|NCT00425269|Secondary|Triglycerides, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
1251275|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)|Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.|24 weeks|Intent to Treat population; Last Observation Carried Forward|||Ratio||Standard Error|Least Squares Mean
1251276|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)|Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.|24 weeks|Intent to Treat population; Last Observation Carried Forward|||Ratio||Standard Error|Least Squares Mean
1251277|NCT00500370|Secondary|Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)|Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||(mmol*hr)/L||Standard Error|Least Squares Mean
1251278|NCT00500370|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)|24 weeks|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
1251279|NCT00500370|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
1251280|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)|Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||Ratio||Standard Error|Least Squares Mean
1251281|NCT00500370|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
1251282|NCT00500370|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
1251283|NCT00500370|Secondary|Percentage of Patients Experiencing >=5% Weight Loss|Percentage of exenatide and placebo treated patients experiencing >=5% weight loss after 24 weeks of treatment (i.e., [weight at week 0 minus weight at week 24] divided by weight at week 0 times 100% >=5%)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||percentage of patients|||Number
1251284|NCT00500370|Secondary|Change in Waist-to-hip Ratio|Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.|24 weeks|Intent to Treat population|||Ratio||Standard Error|Least Squares Mean
1251285|NCT00500370|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)|24 weeks|Intent to Treat population|||kg/m^2||Standard Error|Least Squares Mean
1251286|NCT00500370|Primary|Change in Body Weight|Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)|24 weeks|Intent to Treat population|||kg||Standard Error|Least Squares Mean
1251287|NCT00500357|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)|Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.|||geometric mean concentration (mcg/mL)||95% Confidence Interval|Geometric Mean
1251288|NCT00500357|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)|Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.|||geometric mean concentration (mcg/mL)||95% Confidence Interval|Geometric Mean
1251289|NCT00500357|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1251313|NCT00500318|Secondary|Trough Inspiratory Capacity (IC)|Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).|||L||Standard Error|Least Squares Mean
1261104|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
1251290|NCT00500357|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.|Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)|Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1251291|NCT00500357|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).|Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)|Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.|||percentage of participants|||Number
1251292|NCT00500357|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1251293|NCT00500331|Secondary|Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern|Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. An additional fasting blood sample (serum and plasma) was drawn at Week 0, Week 4, Week 6 and Week 12 or at early withdrawal (up to 14 weeks) and kept in long-term storage for future testing of biomarkers for diabetes and complications of the disease. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Up to 14 weeks|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1251294|NCT00500331|Secondary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern|Full 12-lead ECGs were recorded at screening, Baseline (Week 0), Week 4, Week 12 or early withdrawal, and Week 14 (Follow-up) using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT and corrected QT (QTc) intervals. All 12-lead ECGs were read locally by the Investigator or his/her designate and were forwarded electronically to the central reader for interpretation. If the QTc was >500 milliseconds (msec) on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 msec, the participant was withdrawn from the study.|Up to Early withdrawal (Between Week 12 and Week 14)|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1251295|NCT00500331|Secondary|Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern|Vital signs included heart rate and blood pressure. Heart rate and blood pressure were taken before blood draws were performed. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. Heart rate and blood pressure was measured pre-dose in duplicate at the specified visits, after the participant had been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Heart rate was measured at the same time as blood pressure using the standardized blood pressure equipment that was provided. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Up to 14 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1251296|NCT00500331|Secondary|Number of Participants With On-therapy Hypoglycemia|Hypoglycemia is low blood glucose or low blood sugar. Hypoglycemic events were collected separately and reported separately from AE, including supplemental data which were not collected for AE. However, any hypoglycemic event which met the criteria for a SAE was included in the SAE summaries. The number of participants in each group that experienced a hypoglycemic event was summarized by frequency of the events.|Up to 14 weeks|Safety Population.|||Participants|||Count of Participants
1251297|NCT00500331|Secondary|Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 12 weeks|Safety population which comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1255985|NCT00462644|Secondary|Intensive Care Unit (ICU) Length of Stay|ICU length of stay in days|time from hospital admission to transfer out of ICU to floor bed||||days||Standard Deviation|Mean
1251298|NCT00500331|Secondary|Change From Baseline in C-peptide AUC During a 2-hr OGTT|Post-prandial assessments of C-peptide were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time “0” started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)|OGTT with LOCF Population. Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.|||Nanomol*hour per Liter (nmol*hr/L)||Standard Deviation|Mean
1251299|NCT00500331|Secondary|Change From Baseline in Insulin AUC During a 2-hour OGTT|Post-prandial assessments of insulin were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time “0” started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12 (0 to 2-hour OGTT)|OGTT with LOCF Population. Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.|||Picomol*hour per Liter (pmol*hr/L)||Standard Deviation|Mean
1251300|NCT00500331|Secondary|Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT)|Post-prandial assessments of glucose were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time “0” started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)|The OGTT Population with LOCF which comprised of participants in the ITT population having evaluable Baseline and corresponding on-therapy OGTT measurements (for at least one of the measured parameters of FPG, C-Peptide or Insulin). Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.|||Millimol*hour per Liter (mmol*hr/L)||Standard Deviation|Mean
1251301|NCT00500331|Secondary|Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine|A 24-hour urine collection was obtained from all participants at Baseline (Week 0) and Week 12 to measure glucose. Participants were provided with urine collection bottles and cooler prior to these visits and instructed that the urine collections must be kept cold and dropped off at the clinic prior to or at the scheduled visits. Site staff queried participants to determine whether the sample represented a full 24-hour collection. The total volume and the sample date and time were recorded. The entire 24-hour urine collection was well mixed in one container and a urine aliquot obtained. Samples were assayed for glucose. The 24-hour collections were used to derive 24-hour urine glucose excretion corrected for filtered load. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12 (24-hour urine collection)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of filtered glucose molecules||Standard Deviation|Mean
1251302|NCT00500331|Secondary|Change From Baseline to Week 12 in Waist Circumference|Waist circumference of participants was measured from Baseline (Week 0) to Week 12 and recorded in the CRF. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT population with LOCF for withdrawn participants or missing values.|||Centimeters||Standard Deviation|Mean
1251303|NCT00500331|Secondary|Change From Baseline to Week 12 in Body Weight|Weight of participants was measured from Baseline (Week 0) to Week 12 and recorded in the case report form (CRF). Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT population with LOCF for withdrawn participants or missing values.|||Kilograms||Standard Deviation|Mean
1251304|NCT00500331|Secondary|Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C])|Fasted samples for TC, LDL-C, HDL-C and TG were collected at Week 12. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent Change based on log-transformed data: 100*(exponentiated(mean change on log scale)-1)|Baseline (Week 0) and Week 4, Week 8 and Week 12|ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis.|||Percent change||Full Range|Median
1251314|NCT00500318|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1)|Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).|Change from baseline (Visit 4) at Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).|||L||Standard Error|Least Squares Mean
1255986|NCT00462644|Secondary|Hospital Length of Stay|days from admission to hospital discharge|time to hospital discharge in days||||days||Standard Deviation|Mean
1251305|NCT00500331|Secondary|Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L|Fasted blood samples for HbA1c were collected at Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Number of participants at Week 12 with: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 mmo/L (126 milligram/deciliter [mg/dL]), FPG <7.8 mmol/L (140 mg/dL); FPG <5.5 mmol/L (100 mg/dL); a decrease from Baseline of HbA1c >= 0.7%; a decrease from Baseline of FPG ≥1.7 mmol/L (30 mg/dL) are presented.|Week 12|ITT Population with Last Observation Carried Forward (LOCF). Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.|||Participants|||Count of Participants
1251306|NCT00500331|Secondary|Change From Baseline to Week 12 in Fasting Insulin|Fasted blood samples for insulin were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population with LOCF. Only those participants with a value at Baseline and up to Week 12 (after LOCF) were used for this analysis.|||Picomol per Liter (pmol/L)||Standard Deviation|Mean
1251307|NCT00500331|Secondary|Change From Baseline to Week 12 in Fructosamine|Fasted blood samples for fructosamine were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population with LOCF. Only those participants with a value at Baseline up to Week 12 (after LOCF) were used for this analysis.|||Micromol per Liter (mcmol/L)||Standard Deviation|Mean
1251308|NCT00500331|Secondary|Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12|Fasted blood samples for FPG were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 4, Week 8 and Week 12|ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis. One extreme outlier participant had withdrawn from Placebo arm due to lack of efficacy.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
1251309|NCT00500331|Secondary|Change From Baseline in HbA1c (%) at Weeks 4 and 8|Fasted blood samples for HbA1c were collected at Baseline and Weeks 4 and 8. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 4 and Week 8|ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis. One extreme outlier participant had withdrawn from Placebo arm due to lack of efficacy.|||Percentage of hemoglobin||Standard Deviation|Mean
1251310|NCT00500331|Primary|Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12|Fasted blood samples for HbA1c were collected at Baseline and Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Only those participants with a value at Baseline and at Week 12 (after Last Observation Carried Forward [LOCF]) were used for this analysis. Adjusted mean is presented as least square mean.|Baseline (Week 0) and Week 12|Intent to Treat (ITT) Population with LOCF comprised of all randomized participants who received at least one dose of randomized study medication, had a Baseline assessment and had at least one corresponding on-therapy (scheduled or unscheduled) efficacy assessment. One extreme outlier participant had withdrawn from Placebo arm (lack of efficacy).|||Percentage of hemoglobin||Standard Error|Least Squares Mean
1251311|NCT00500318|Secondary|Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio|Ratio of trough Inspiratory Capacity verses Total Lung Capacity.|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1251312|NCT00500318|Secondary|Functional Residual Capacity (FRC)|Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).|||L||Standard Error|Least Squares Mean
1251413|NCT00499252|Secondary|Overall Survival||from entry into the study to death or the date of last contact.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1258238|NCT00445328|Secondary|All Cause Mortality|Subjects with death from any cause: end of study.|Day 14, Day 21 (End of Study)|Intent to treat (ITT)|||participants|||Number
1251315|NCT00500318|Primary|Change From Baseline in Exercise Endurance Time (ET)|Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.|From baseline Week 0 (Visit 4) to Week 6 (Visit 6)|Missing data for patients who withdrew due to COPD exacerbations was imputed using the Worst Observation Carried Forward (WOCF) of all Endurance time (ET), while ETs that were missing for other reasons were imputed using the Last Observation Carried Forward (LOCF) method based on the last visit available.|||Seconds||Standard Error|Least Squares Mean
1251316|NCT00500292|Primary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)||||Participants|||Number
1251317|NCT00500240|Primary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of complete remission and the date of relapse detection or death. Complete Remission (CR) defined as granulocyte count >1.0 × 10^9/L, platelet count >100 × 10^9/L, no abnormal peripheral blasts, and <5% blasts in normocellular or hypercellular bone marrow.|Date of complete remission to disease progression, assessed for approximately 6 years|There were 51 evaluable participants.|||Months||Full Range|Median
1251318|NCT00500240|Primary|Overall Survival|Overall survival (OS) defined as the interval between the date of randomization and the date of death. Calculation of period was from baseline (date of randomization) to the death or last follow-up.|Baseline (date of randomization) to date of death or last follow-up (weekly during treatment then every 2 months post study treatment) up to 6 years||||Months|Participants|Full Range|Median
1251319|NCT00500240|Primary|1-Year Overall Survival Rate|The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months.|1 year|There were 51 evaluable participants.|||percentage of participants||95% Confidence Interval|Number
1251320|NCT00500149|Secondary|Duration of Effect of Vyvanse|Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal).|Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.|Analysis on intention-to-treat (ITT) population.|||scores on a scale||Standard Error|Least Squares Mean
1251321|NCT00500149|Primary|Onset of Effect of Vyvanse|The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).|Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.|Analysis on the intention-to-treat (ITT) population.|||scores on a scale||Standard Error|Least Squares Mean
1251322|NCT00500110|Primary|Number of Participants Achieving Pathological Complete Response|Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.|Every 3 months for 1 year, then every 6 months until disease progression or death|Analysis was per protocol.|||participants|||Number
1251323|NCT00500071|Secondary|Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks|Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.|Baseline and 7 weeks|ITT|||Units on a scale||Standard Deviation|Mean
1251324|NCT00500071|Secondary|Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks|Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.|Baseline and 7 weeks|ITT|||Units on a scale||Standard Deviation|Mean
1251325|NCT00500071|Secondary|Number of Participants With Improvement onParent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7 weeks|ITT|||Participants|||Number
1251326|NCT00500071|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 or 2 on the scale.|7 weeks|ITT|||Participants|||Number
1251327|NCT00500071|Primary|Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 7 weeks|Intent-to-treat (ITT). ITT population defined as all subjects who took at least one dose of drug and had at least one ADHD-RS-IV total score available.|||Units on a scale||Standard Error|Mean
1251328|NCT00500071|Secondary|Weekly Change From Baseline in Total ADHD-RS-IV Score|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks|ITT|||Units on a scale||Standard Error|Mean
1251329|NCT00499915|Secondary|Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.||2, 5, and 7-9 months post baseline|||||||
1251330|NCT00499915|Primary|Infants Living in Smoke-free Environments.|"Infants living in homes with a home smoking ban rule"|5 months post baseline||||participants|||Number
1251448|NCT00498706|Secondary|Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)||Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up|||||||
1251331|NCT00499889|Secondary|Participants' With mCR Response to Post Transplant DLI|Number of participants with response of molecular complete remission (mCR) to DLI as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.|1 year|Only 8 participants having the post-transplant DLI out of the 41 participants treated were analyzed for this outcome.|||Participants|||Number
1251332|NCT00499889|Primary|Number of Participants in Complete Molecular Remission at 1 Year|Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).|Baseline to 1 year|Analysis was per protocol. One patient did not receive treatment and was excluded from analysis.|||participants|||Number
1251333|NCT00499889|Secondary|Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy|Number of participants with response of molecular complete remission (mCR) to Imatinib Mesylate therapy as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.|1 Year|Analysis was per protocol. Only 19 participants having the post transplant Imatinib Mesylate Therapy out of the 41 participants treated were analyzed for this outcome.|||Participants|||Number
1251334|NCT00499863|Secondary|Change From Baseline in Weight at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population|||lbs||Standard Deviation|Mean
1251335|NCT00499863|Secondary|Change From Baseline in Diastolic Blood Pressure at Endpoint||Baseline and endpoint (up to 7 weeks)||||mmHg||Standard Deviation|Mean
1251336|NCT00499863|Secondary|Change From Baseline in Systolic Blood Pressure at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population|||mmHg||Standard Deviation|Mean
1251337|NCT00499863|Secondary|Change From Baseline in Pulse Rate at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population|||bpm||Standard Deviation|Mean
1251338|NCT00499863|Secondary|Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and endpoint (up to 7 weeks)|Safety population|||msec||Standard Deviation|Mean
1251339|NCT00499863|Secondary|Dermal Response Scale (DRS) Scores|Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|up to 7 weeks|Safety population which included all randomized subjects that received at least one dose of MTS or PTS.|||scores on a scale||Standard Deviation|Mean
1251340|NCT00499863|Other Pre-specified|Post Sleep Questionnaire (PSQ) Quality of Sleep|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|up to 7 weeks|Safety population (Note: not everyone in the safety population completed a sleep questionnaire)|||Participants|||Number
1251341|NCT00499863|Secondary|Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint|The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often).|Baseline and endpoint (up to 7 weeks)|ITT|||scores on a scale||Standard Error|Least Squares Mean
1251342|NCT00499863|Secondary|Improvement in Parent Global Assessment (PGA) Score|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 7 weeks|ITT|||Participants|||Number
1251343|NCT00499863|Secondary|Improvement in Clinical Global Impressions-Improvement (CGI-I) Score|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 7 weeks|ITT|||Participants|||Number
1251344|NCT00499863|Secondary|Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true).|Baseline and endpoint (up to 7 weeks)|ITT|||scores on a scale||Standard Error|Least Squares Mean
1251345|NCT00499863|Primary|Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint|The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|baseline and endpoint (up to 7 weeks)|Intent-to-treat (ITT) which included all randomized subjects who received at least one dose of MTS or PTS, and had one Baseline and at least one post-Baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
1251346|NCT00500266|Primary|Percentage of Participants Taking Pain or Antipyretic Medication|Use of pain or antipyretic medication was collected by the participants using an electronic diary.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as “yes” for at least 1 day or as “no” for all days.|||Percentage of Participants||95% Confidence Interval|Number
1251347|NCT00500266|Primary|Percentage of Participants With Pre-specified Systemic Events|Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as “yes” for at least 1 day or as “no” for all days.|||Percentage of Participants||95% Confidence Interval|Number
1259209|NCT00439218|Secondary|Pharmacokinetic Parameters (Maximum Plasma Concentration)|Maximum Plasma Concentration (Cmax)|12 weeks||||µM||Standard Deviation|Mean
1251348|NCT00500266|Primary|Percentage of Participants With Pre-specified Local Reactions|Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting “yes” for at least 1 day or “no” for all days.|||Percentage of Participants||95% Confidence Interval|Number
1251349|NCT00499746|Secondary|Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)|"The Visual Analog Scale (VAS) measures subjective ratings of stimulant effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure."|Measure at 120 min after drug administration||||units on a scale||Standard Error|Mean
1251350|NCT00499746|Secondary|Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)|"The Visual Analog Scale (VAS) measures subjective ratings of opioid agonist effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure on VAS."|Measure at 120 min after drug administration||||units on a scale||Standard Error|Mean
1251351|NCT00499746|Secondary|Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter|Change in pupil diameter (mm) at peak (120 min) compared to baseline measure of pupil diameter|Measure at 120 min after drug administration||||mm||Standard Error|Mean
1251352|NCT00499746|Secondary|Physiologic Effects Assessed by the Pharmacological Class Questionnaire|"During the peak (assessed at 120 min) of each drug administration, participants were asked to complete the pharmacological class questionnaire. The pharmacological class questionnaire had volunteers indicate which drug class was most similar to the drug condition they received. Ten drug classes were listed with descriptive labels and examples of each: placebo, opiates (or opioid agonist), phenothiazines, barbiturates, antidepressants, opiate antagonists, hallucinogens, benzodiazepines, stimulants, and other. Of these choices, participants chose 3: placebo, opioid agonist, and stimulant.~The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition."|Measure at 120 min after drug administration||||percentage of drug identification|||Number
1251353|NCT00499746|Primary|Discrimination Effects Assessed by Discrete Choice|"During discrete choice, volunteers were given three choices (placebo, hydromorphone, methylphenidate) and were asked to choose which of the training drugs they thought they received. The outcome measure illustrates the percentage of participants who chose either placebo, hydromorphone, or methylphenidate during each drug condition (i.e., Placebo, Hydromorphone 8 mg, Tramadol 50 mg, etc.), ranging from 0-100.~The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition."|1 day||||percentage of drug identification|||Number
1251354|NCT00499746|Primary|Discrimination Effects Assessed by Point Distribution|In point distribution, volunteers distributed 50 points among three training drug letters depending on how certain they were of the identity of the administrated drug. Maximum total is 50 points.|1day||||Points distributed||Standard Error|Mean
1251355|NCT00499746|Primary|Discrimination Effects Assessed by Operant Responses|Volunteers emitted operant responses on computer keys that corresponded to the training letter, on a fixed interval 1 second schedule for 8.5 minutes. The range is from 0 to 500 operant responses.|1 day||||Responses||Standard Error|Mean
1251356|NCT00499746|Primary|Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test|The acquisition of discrimination was to test whether volunteers could identify each training drug condition by the correct letter code. Results are the percentage of correct responses with a range of 0% to 100%.|1 day||||percent of correct response||Full Range|Mean
1251357|NCT00499694|Secondary|Overall Survival|Overall survival using the Kaplan-Meier method|Followed every 3 months after treatment is discontinued||||months||90% Confidence Interval|Median
1251358|NCT00499694|Secondary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|Prostate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels|Day 1 of every cycle (35 days) and Day 15 of every cycle||||pct. of pts. with 50%+ decrease in PSA||90% Confidence Interval|Number
1251359|NCT00499694|Secondary|Toxicity, Presented as the Number of Participants With Adverse Events|Toxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0).|Day 1 of every cycle (35 days) and Day 15 of every cycle||||Participants|||Count of Participants
1251360|NCT00499694|Primary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit.|Every 70 days||||months||90% Confidence Interval|Median
1251361|NCT00499681|Primary|Number of Participants With a Pathological Complete Response|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|at 14 weeks|Participants who were available for measurement of response.|||participants|||Number
1251362|NCT00499655|Secondary|Progression-free Survival - Low PGEM|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with low baseline urinary prostaglandin E metabolite (PGEM).|||Months||95% Confidence Interval|Median
1261007|NCT00425945|Secondary|Triglycerides|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||mg/dL||Standard Deviation|Mean
1251363|NCT00499655|Secondary|Progression-free Survival - EGRF|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with wild-type epidermal growth factor receptor (EGFR),|||Months||95% Confidence Interval|Median
1251364|NCT00499655|Secondary|Progression-free Survival - Elevated PGEM|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with elevated baseline urinary prostaglandin E metabolite (PGEM).|||Months||95% Confidence Interval|Median
1251365|NCT00499655|Secondary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|16 weeks post start of treatment||||Participants|||Count of Participants
1251366|NCT00499655|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|All patients receiving treatment.|||Months||95% Confidence Interval|Median
1251367|NCT00499616|Secondary|Prognostic Ability of the INRG Image-defined Risk Factor (IDRF) System|A Kaplan – Meier curves of presence vs absence of one or more IDRFs will be generated, and a log rank test performed to compare them, for EFS and OS. The IDRF data will be used to determine the International Neuroblastoma Risk Group Stage (INRGSS) and Kaplan-Meier curves by INRGSS will be generated. To compare the institutional assessment of IDRFs (presence vs absence) with the central review assessment of IDRFs, a chi-square test will be performed. ROC curves will be generated, and the sensitivity and specificity of the institutional assessment will be calculated|At baseline, during and after completion of study treatment|||||||
1251368|NCT00499616|Secondary|Association Between Surgical Biopsy Technique With Adequacy of Tissue Acquisition for Biologic Studies, and With Complications Associated With the Biopsy Procedure|A chi-square test will be performed.|During and after surgery|The data was not collected to assess this study aim.||||||
1251369|NCT00499616|Secondary|Proportion of Patients With Neurologic Symptoms Overall and Type of Symptom|Descriptive analysis will be used.|On treatment and post-treatment|||||||
1251370|NCT00499616|Secondary|Biological Surrogate Markers|Multivariable analyses will be performed to identify variables of prognostic interest.|At baseline and surgery|The data was not collected to assess this study aim.||||||
1251371|NCT00499616|Secondary|Overall Survival Time|Kaplan-Meier curves and life tables of E2FS and OS (from the time of first event) will be generated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.|From the time of the first progressive, non-metastatic event|||||||
1251372|NCT00499616|Secondary|Second-event-free Survival (E2FS) of Intermediate Risk Patients|Kaplan-Meier curves and life tables of E2FS and OS (from the time of first event) will be generated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.|From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse, progressive disease, secondary malignancy, or death|||||||
1251373|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate|To test for the association of the extent of surgical resection (CR vs <CR) with surgical complications rate (complications of any kind vs no complications at all), a chi-square test will be performed.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery|||Proportion with surgical complications||95% Confidence Interval|Number
1251374|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates|To test the predictive ability of the extent of surgical resection for OS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery.|||percentage of OS rate||95% Confidence Interval|Number
1251375|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS)|To test the predictive ability of the extent of surgical resection for EFS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery|||percentage of 3 yr EFS survival||95% Confidence Interval|Number
1251376|NCT00499616|Primary|Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment|Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy.|From baseline to up to 10 years|Eligible and evaluable patients with Stage 4S neuroblastoma unable to undergo biopsy.|||percentage survival||95% Confidence Interval|Number
1251377|NCT00499616|Primary|Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma|Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event.|Up to 3 years|Eligible and evaluable patients with Stage 4S neuroblastoma that had a biopsy or resection.|||Proportion||95% Confidence Interval|Number
1251378|NCT00499616|Primary|Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961|Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age|Up to 3 years|Eligible and evaluable patients with Stage 3 neuroblastoma, 12-18 months of age, MYCN non-amplified, and unfavorable histology.|||percentage of 3 yr EFS rate|||Number
1251379|NCT00499616|Primary|Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961|Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age.|Up to 3 years|Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features.|||percentage of 3 yr EFS rate||95% Confidence Interval|Number
1251380|NCT00499616|Primary|Definitive Determination of the Prognostic Ability of 1p and 11q|Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q.|At baseline|Eligible intermediate risk patients with 1p and 11q data.|||percentage of 3 yr EFS/OS rate||95% Confidence Interval|Number
1251381|NCT00499616|Primary|Overall Survival (OS) Rates|OS time is calculated from date of enrollment until death, or until last contact if the patient is alive.|3 years|Eligible intermediate risk patients.|||percentage of participants||95% Confidence Interval|Number
1251382|NCT00499603|Secondary|Participant Responses Per Treatment Arm at 24 Weeks|Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.|24 weeks|Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.|||participants|||Number
1251383|NCT00499603|Secondary|Participant Responses Per Treatment Arm at 12 Weeks|Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.|12 weeks|Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.|||participants|||Number
1251384|NCT00499603|Primary|Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours|Number of participants with inhibition of the PI3K/PTEN/AKT pathway at 48 hours after the start of treatment, regardless of the status of the pathway at the time of randomization. Molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway evaluated using reverse phase protein arrays (RPPA) where fine-needle aspirations (FNAs) from the primary breast cancer obtained pretreatment, and at 48 hours. Bioinformatics cluster analysis of arrays used to define molecular changes as inhibition or activation where pathways called 'active' with presence of 2 or more phosphorilated pathway proteins (pAKT, pmTOR, pGSK3, pS6K1, pS6), and 'inhibited' with one or none phosphorilated pathway proteins present.|48 hours after start of treatment|Participants were randomly assigned 1:1 to receive T-FEC or TR-FEC using a balanced block design stratified by disease stage and menopausal status. One participant in Arm 2 started treatment but had untolerable side effects and was taken off the study and thus was considered inevaluable.|||participants|||Number
1251385|NCT00499590|Secondary|Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision||Week 60|Zero participants analyzed due to early termination of the study.||||||
1251386|NCT00499590|Primary|Visual Acuity|avoidance of 3 or more lines of vision loss|week 60|Zero participants analyzed due to early termination of the study.||||||
1251387|NCT00499486|Primary|Severity of Adverse Events as Assessed by NCI CTCAE v3.0||6 months||||percentage of Adverse Events|||Number
1251388|NCT00499486|Primary|Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Response for Stable disease was assessed at 2 months and for complete and partial response at 6 months.|response at 2 and 6 months||||participants|||Number
1251389|NCT00499486|Primary|Percentage of Patients With Overall Survival at 6 Months||6- month survival rate (6mSR)||||% of participants|||Number
1251390|NCT00499473|Secondary|Overall Survival||up to 12 months||||months||Full Range|Median
1251391|NCT00499473|Secondary|Percentage of Patients Progression Free at 12 Months||At 12 months after the start of treatment||||percent of patients|||Number
1251392|NCT00499473|Secondary|Confirmed Objective Response (Complete Response[CR] or Partial Response [PR])|Confirmatory scans should also be obtained within 4 to 6 weeks following initial documentation of objective response. Confidence intervals for the true proportion will be calculated using the exact binomial method. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 weeks|Only 21 patients were evaluable for response|||patients|||Number
1251393|NCT00499473|Primary|Dose Resulting in Steady-state Trough|Average of pre-dose values of sunitinib + SU12662 plasma concentrations equivalent to that observed in patients not receiving EIAC based on pharmacokinetic modeling.|At baseline (day 8) and days 15, 22, and 23|Not determined due to early termination of the study due to lack of efficacy||||||
1251449|NCT00498706|Primary|Number of Participants Who Dropped Out of Therapy|"Using the number of therapy sessions attended, we categorized patients into:~those who discontinued treatment before session 18, and those who completed session 18.~those who discontinued before Session 5, and those who continued."|Post treatment, up to 18 weeks||||participants|||Number
1251394|NCT00499473|Primary|Maximum Tolerable Dose Based on Dose-limiting Toxicity of Sunitinib in Patients Receiving EIAC (Stratum 2)|Maximum tolerable dose of sunitinib in patients receiving treatment with EIAC agents using dose escalation based on the steady-state trough sunitinib + SU12662 plasma concentrations on day 14 observed in patients treated in stratum 1. Six patients will be treated in each dose cohort with up to 12 patients being treated at the maximum tolerable dose for a total of 18-24 patients with gliomas receiving EIAC.|From the time of first treatment with sunitinib until completion of treatment, assessed up to 30 days|MTD in Stratum 2 not determined due to lack of efficacy in Stratum 1||||||
1251395|NCT00499473|Primary|Progression-free Survival at 6 Months (Stratum 1)|Number of patients with Progression-free Survival at 6 months for Stratum 1|From time to registration to up to 6 months|Only 21 patients were evaluable for PFS|||patients|||Number
1251396|NCT00499460|Secondary|Oral Digoxin Test|Digoxin when given orally is a probe substrate for the efflux activity of P-glycoprotein in the small intestine. The phenotype index in this case is the area under the plasma digoxin concentration from time zero to 240 min after a 0.5-mg oral test dose. A decrease in oral digoxin AUC indicates an enhanced activity of P-glycoprotein, possibly as a result of transporter upregulation.|Serial blood sampling over 4 hours after a 0.5-mg oral test dose of digoxin||||(ng/mL)*min||Standard Deviation|Mean
1251397|NCT00499460|Secondary|Oral Midazolam Test|Midazolam when given orally is a probe substrate for the in vivo intestinal and hepatic activity of CYP3A (Cytochrome P450 3A) enzymes. The phenotype index in this case is the area under the plasma midazolam concentration from time zero to 360 min after a 5-mg oral test dose. A decrease in oral midazolam AUC indicates enhanced activity of CYP3A enzymes, possibly as a result of enzyme induction.|Serial blood sampling over 6 hours after a 5-mg oral test dose of midazolam||||(ng/mL)*min||Standard Deviation|Mean
1251398|NCT00499460|Secondary|Cognitive-Affective Side Effects Total Score|Subjects rated the mental side effects they experienced at 90, 150 and 300 min after oxycodone administration on a 36-item Cognitive-Affective Side Effects (CASE) questionnaire. Total score (i.e., average of the scores for all 36 items) ranges on a numerical scale from 0 (no somatic side effects) to a maximum of 4 (extreme somatic aide effects). Only the peak CASE scores at 150 min are reported herein.|CASE scores at 150 min after a single 15-mg oral dose of oxycodone||||units on a scale||Standard Deviation|Mean
1251399|NCT00499460|Secondary|Somatic Side Effects Total Score|Subjects rated the bodily side effects they experienced at 90, 150 and 300 min after oxycodone administration on a 35-item Somatic Side Effects (SSE) questionnaire. Total score (i.e., average of the scores for all 35 items) ranges on a numerical scale from 0 (no somatic side effects) to a maximum of 4 (extreme somatic aide effects). Only the peak SSE scores at 150 min are reported herein.|SSE scores at 150 min after a single 15-mg oral dose of oxycodone||||units on a scale||Standard Deviation|Mean
1251400|NCT00499460|Secondary|Cold Pressor Tolerance AUC|Cold Pressor Test measures response to experimentally induced pain, in this case by immersion of a subject's hand in icy-cold water. Tolerance is the duration of time a subject is able to keep his/her hand immersed in the cold water. A prolongation in tolerance time indicates analgesic response to oxycodone treatment. Cold Pressor Tolerance AUC is the area under the tolerance versus time curve over a 300-min period after a test dose of oxycodone. Because of non-normality in sample distribution, log transformed AUC estimates were analyzed by Generalized Linear Model.|Repeated testing for tolerance to Cold Pressor Test just before and at 45, 90, 150 and 300 min after a single 15-mg oral dose of oxycodone||||log (sec*min)||Standard Deviation|Mean
1251401|NCT00499460|Primary|Oxycodone Oral Clearance|Oxycodone oral clearance is computed by Dose/AUC, where AUC is the area under the plasma oxycodone concentration-time curve from time zero to infinity. Oral clearance is a measure of the rate at which oxycodone is cleared from the body via metabolism.|Serial blood sampling over 24 hours after a 15-mg oral dose of oxycodone||||L/min||Standard Deviation|Mean
1251402|NCT00499447|Primary|Two Year Progression Free Survival Rate|the number of patients surviving progression-free at two years.|2 years||||participants|||Number
1251403|NCT00499408|Secondary|Time to Progression|Progression will be defined as a 50% rise in serum PSA compared to the baseline value confirmed on at least two measurements at least two weeks apart.|up to three years|16 subjects progress out of the 23 evaluable for response.|||months||Full Range|Median
1251404|NCT00499408|Secondary|Number of Adverse Events, Grades 1-5|Toxicity will be graded according to the revised NCI Common Terminology Criteria for Adverse Events v 3.0, (CTCAE). Number of events with grade 1-5 will be reported.|up to one year||||events|||Number
1251405|NCT00499408|Secondary|Changes in PSA Doubling Time||up to one year|Data not collected||||||
1251406|NCT00499408|Secondary|Changes in PSA Slope||up to one year|Data not collected||||||
1251407|NCT00499408|Primary|Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment||up to one year|Only 23 participants evaluable for a response.|||participants|||Number
1251408|NCT00499369|Secondary|Toxicity|Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1251409|NCT00499369|Primary|Progression-free Survival (PFS)|PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 5 years|All eligible patients are included in this analysis.|||months||95% Confidence Interval|Median
1251410|NCT00499369|Secondary|Objective Tumor Response||Up to 5 years|No participants were analyzed due to limited accrual.||||||
1251411|NCT00499369|Secondary|Overall Survival|Time to death is from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 5 years|No participants were analyzed due to limited accrual.||||||
1251412|NCT00499343|Primary|CD34+ Cells/kg in Blood Stem Cells|After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.|The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.||||CD34+ cells/kg||Full Range|Median
1261008|NCT00425945|Secondary|HDL|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||mg/dL||Standard Deviation|Mean
1251414|NCT00499252|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|from study entry until disease progression, death or date of last contact.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1251415|NCT00499252|Primary|Frequency and Severity of Observed Adverse Effects||Every cycle during treatment and up to 5 years after completion of treatment|Treated and Eligible patients|||Participants|||Count of Participants
1251416|NCT00499252|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels|Eligible and Treated Patients|||Percentage of participants||95% Confidence Interval|Number
1251417|NCT00499122|Secondary|Correlation Between Myeloid Derived Suppressor Cell (MDSC) Levels and Pathologic Complete Response (pCR) and Non-Responders|The investigators hypothesized that patients with favorable responses, i.e. pCR, are more likely to have significantly lower levels of MDSCs than non-responders. MDSC levels will be measured at baseline and on day 1 of each treatment cycle, cycles 1 through 8.|Baseline, Day 1 of Cycles 1 through 8, about 7 months|Study participants who were evaluable for pathologic response.|||MDSC/uL||Standard Error|Mean
1251418|NCT00499122|Secondary|Definition of the Safety Profiles of Protocol Therapy|Definition of the safety profiles of protocol therapy in study participants as shown by the number of study participants experiencing adverse events or other toxicity.|Up to 30 days Post-Last Dose of Protocol Therapy, About 7 months||||participants|||Number
1251419|NCT00499122|Primary|Rate of Pathologic Complete Response in the Affected Breast After Protocol Therapy|The primary objective of this study is to define the rate of pathologic complete response rate (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with stage IIB-IIIC breast cancer. Pathologic complete response (pCR) is defined according to Hankoop et al [41] as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.|About 7 months|Assessable tumors from study participants who had received at least one cycle of protocol therapy.|||percentage of tumors|Tumors|95% Confidence Interval|Median
1251420|NCT00499109|Secondary|Response Rate (RR)|Number of participants per response category. Response to treatment was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|6 months|All evaluable participants|||participants|||Number
1251421|NCT00499109|Secondary|Overall Survival (OS)|OS at 12 months, determined from the date of randomization. The time interval from randomization to the date of death was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the overall survival.|12 months|All participants|||estimated percentage of participants||95% Confidence Interval|Number
1251422|NCT00499109|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the PFS at 6 months.|6 months|All participants|||estimated percentage of participants||95% Confidence Interval|Number
1251423|NCT00499096|Secondary|Body Mass Index (BMI)|Body mass index (BMI) is reported in kilograms divided by meters squared (kg/m^2) with a normal (healthy) range of 18-24, in which >=25 is considered overweight, and >=30 is the definition of obesity|24 months||||kg/m^2||Standard Deviation|Mean
1251424|NCT00499096|Secondary|Disability Based on WHO-DAS Score|Disability based on the WHO Disability Assessment Scale (WHO-DAS); range = 0-24, higher score equals greater disability|24 months||||units on a scale||Standard Deviation|Mean
1251425|NCT00499096|Secondary|Depressive Symptom Score|Depressive symptoms based on the Internal State Scale (Range: 0-200, higher score = more severe symptoms)|24 months||||units on a scale||Standard Deviation|Mean
1251426|NCT00499096|Primary|Physical Health-related Quality of Life Score|Physical health-related quality of life is based on the Short Form (SF)-12 survey physical health component (PCS) score- which ranges from 0 to 50, with higher scores indicating higher quality of life|24 months||||units on a scale||Standard Deviation|Mean
1251427|NCT00499096|Primary|Total Cholesterol|Total cholesterol in mg/dl- lower is better|24 months||||mg/dL||Standard Deviation|Mean
1251428|NCT00499096|Secondary|Manic Symptoms|Manic symptoms based on the Internal State Scale (range is 0-500; higher score indicates more severe symptoms)|24 months||||units on a scale||Standard Deviation|Mean
1251429|NCT00499096|Primary|Systolic and Diastolic Blood Pressure (SBP, DBP)|24-month systolic and diastolic blood pressure (mm/Hg): lower is better|24 months||||mm/Hg||Standard Deviation|Mean
1251430|NCT00499083|Secondary|Influence of Tumor COX-2 and VEGF Expression on Dendritic Cell-mediated Tumor-specific Immunity|T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.|Post-vaccination peripheral blood (PB) after the last chemotherapy.|Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.||||||
1251431|NCT00499083|Secondary|Antibody-dependent Cell-mediated Cytotoxicity|T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.|Post-vaccination peripheral blood (PB) after the last chemotherapy.|Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.||||||
1251432|NCT00499083|Secondary|Inflammatory Cell Infiltration|T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.|Post-vaccination peripheral blood (PB) after the last chemotherapy.|Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.||||||
1251433|NCT00499083|Primary|Number of Patients With Pathological Complete Response|"Assessed by the institutional pathologist.~Grade 1: disappearance of all tumor on microscopic assessment in the breast and LNs~Grade 2: presence of in situ carcinoma only in the breast, no invasive tumor, and no tumor found in the LNs~Grade 3: presence of invasive carcinoma with stromal alteration, such as sclerosis or fibrosis~Grade 4: no or few modifications of the tumor appearance"|At definitive surgery.||||participants|||Number
1251434|NCT00499031|Secondary|Duration of Overall Survival||From study entry to death or the date of last contact, up to 5 years|||||||
1251435|NCT00499031|Secondary|Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years|||||||
1251436|NCT00499031|Secondary|Duration of Objective Response Rate||Up to 5 years|||||||
1251437|NCT00499031|Secondary|Duration of Progression-free Survival||From study entry until disease progression, death or date of last contact, up to 5 years|||||||
1251438|NCT00499031|Primary|Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|every other cycle for the first 6 months; then every 3 months x 2; then every 6 months|Total number of eligible and evaluable participants|||participants|||Number
1251439|NCT00499031|Primary|Progression-free Survival Greater Than 6 Months||At 6 months|Total number of eligible and evaluable participants|||participants|||Number
1251440|NCT00498940|Secondary|Number of Subjects With Postoperative Complications|This is to measure the total number of subjects that experienced any of the following complications: sepsis/infection, renal failure, respiratory failure/complications, bleeding requiring reoperation, cerebrovascular accident.|30 days after surgery||||participants|||Number
1251441|NCT00498940|Primary|Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).|Cardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.|24 hours||||L/min/m^2||Standard Error|Mean
1251442|NCT00498927|Secondary|Overall Survival|All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.|2 years|Glioblastoma patients|||months||95% Confidence Interval|Median
1251443|NCT00498927|Primary|Progression-free Survival (PFS) Rate at 6 Months|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 6 months|Glioblastoma patients|||percentage of participants|||Number
1251444|NCT00498797|Secondary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)||||Participants|||Number
1251445|NCT00498797|Primary|Prostate Specific Antigen (PSA) Response|Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response|PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline||||Participants|||Number
1251446|NCT00498706|Primary|Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)|Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant.|Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up||||units on a scale||Full Range|Mean
1251447|NCT00498706|Primary|Patient Health Questionnaire (PHQ)-9|Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment.|Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up||||units on a scale||Full Range|Mean
1254826|NCT00470366|Secondary|Number of Patients With Treatment Related Toxicity|Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0|3 years||||Participants|||Count of Participants
1251450|NCT00498706|Primary|Attrition (Number of Therapy Sessions Attended)|Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.|Post treatment, up to 18 weeks|A randomized controlled trial of 325 Chicago area primary care patients with major depressive disorder, recruited from November 1007 to December 2010.|||Number of Sessions|Participants|Standard Deviation|Mean
1251451|NCT00498628|Secondary|Quality of Life SF - 12|The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy and allows for calculation of the physical and mental component summary scores.|Week 12|||||||
1251452|NCT00498628|Secondary|Sleep Quality Score|The Pittsburgh Sleep Quality Index is a 19-item questionnaire with seven sub scales (subjective sleep quality, sleep latency, sleep duration, habitual sleep disturbances, use of sleep medication and day time dysfunction) (Buysse et al., 1989). Each sub-scale is rated from 0–3 with the higher scores reflecting more severe sleep complaints. The addition of all the scores permits an analysis of the subject’s overall sleep experience in the past 30 days. The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations.|Weeks 4, 8 and 12|||||||
1251453|NCT00498628|Secondary|Hamilton Anxiety Scale (HAM-A)|The Hamilton Anxiety Scale consists of 14 items, each defined by a series of symptoms. Similar to the HAM-D, each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). (Guy, 1976).|Weeks 4, 6, 8, 10 and 12|||||||
1251454|NCT00498628|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression (Montgomery and Asberg, 1979). The scale was constructed to be sensitive to changes in treatment effects. Its capacity to differentiate between responders and non-responders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression, another established measure of depressive symptomatology, but the MADRS has greater sensitivity to change during the course of a depressive phase. It has exhibited high inter-rater reliability and appears to be oriented more towards psychic as opposed to somatic aspects of depression. The MADRS is a 10-item checklist where items are rated on a scale of 0 to 6 with anchors at 2-point intervals. Scores range from 0 to 60.|Week 4, 6, 8, 10, and 12|||||||
1251455|NCT00498628|Secondary|Penn Alcohol Craving Score (PACS_|The Penn Alcohol Craving Scale (PACS) is a five-item, self-report measure that includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week (Flannery et al., 1999). Based on clinical study results, the PACS have been shown to be a reliable and valid measure of alcohol craving and can predict subjects at risk for subsequent relapse.|Week 4, 6, 8, 10, 12|||||||
1251456|NCT00498628|Secondary|Drinking Consequences Score|Drinkers Inventory of Consequences (DrInC) - Alcohol-related problems are determined using the DrInC (Miller et al., 1995). The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Each scale provides a lifetime and past 3-month measure of adverse consequences, and scales can be combined to assess total adverse consequences. At baseline the DrInC-2R will be used to assess the 90-day period prior to baseline. For weeks 6 and 12, the DrInC-2R will be used, but will be modified to assess alcohol-related problems over the previous 6-week period.|Weeks 6 and 12|||||||
1251457|NCT00498628|Secondary|Percent Subjects With no Heavy Drinking Day||3-11|||||||
1251458|NCT00498628|Secondary|Percent Subjects Abstinent||3-11|||||||
1251459|NCT00498628|Secondary|Percent Very Heavy Drinking Day||3-11|||||||
1251460|NCT00498628|Secondary|Drinks Per Day||3-11|||||||
1251461|NCT00498628|Secondary|Drinks Per Drinking Day||3-11|||||||
1251462|NCT00498628|Secondary|Percent Days Abstinent|Percentage of days abstinent (PDA) between Study Days 15 and 77|3-11|||||||
1251463|NCT00498628|Primary|Percent Heavy Drinking Days|A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.|Weeks 3 - 11|Intention to Treat|||percentage of heavy drinking days||Standard Error|Least Squares Mean
1251464|NCT00498615|Primary|Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge.|The time to recover 70% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.|within 60 minutes||||minutes||Standard Deviation|Mean
1251465|NCT00498615|Secondary|The Blood Flow by Laser Doppler Scans of the Fingers|The measurement of the blood flow of participants prior to cold challenge 2 hours after receiving study.|Blood flow prior to cold challenge 2 hours after taking study drug||||perfusion units||Standard Deviation|Mean
1251466|NCT00498615|Primary|The Time to Recover 50% of Fall in the Baseline Skin Temperature.|The time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.|within 60 minutes||||minutes||Standard Deviation|Mean
1251467|NCT00498602|Secondary|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)|IgG subtypes were not assessed|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|||||||
1251468|NCT00498602|Secondary|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/mL||95% Confidence Interval|Geometric Mean
1251573|NCT00497146|Secondary|Change in Isovolumetric Relaxation Time (IVRT)|Isovolumetric relaxation time (IVRT) is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||seconds||Standard Error|Least Squares Mean
1251469|NCT00498602|Secondary|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/mL||95% Confidence Interval|Geometric Mean
1251470|NCT00498602|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose|The safety population included all randomized participants with documented use of at least one dose of study drug.|||percentage of participants|||Number
1251471|NCT00498550|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|This study utilized the 24 item BPRS. Each item is rated a 0 (not present) to 6 (severe) scale. The minimum score for this assessment is 0 and the maximum score is 144.|12 weeks||||BPRS Score||Standard Deviation|Mean
1251472|NCT00498550|Primary|Days of Cannabis Use as Measured by the Timeline Followback||12 weeks|||||||
1251473|NCT00498485|Primary|Self Reported Assessment of Sleep|Subjects were asked to provide their input as to the quality of their sleep over the past week|Assessed at week 6|While data were collected, these data were never analyzed because the study was terminated prematurely by the sponsor and were lost when PI moved from UMDNJ to Beth Israel in NYC in 2008.||||||
1251474|NCT00498485|Primary|Global Assessment of Change|A count was made of subject responses on a Patient Assessment of Change questionnaire where scores went from +2 [much better] thru 0 [no change] to -2 [much worse]|6 weeks|Had we completed the study, the analysis would have been a comparison of counts of those reporting being very much improved across the two treatment conditions|||participants|||Number
1251475|NCT00498433|Secondary|Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death||98 days|The safety population consisted of all patients who received at least one dose of study drug with at least one post-baseline safety assessment. Patients were analyzed according to treatment received.|||Participants|||Number
1251476|NCT00498433|Secondary|Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251477|NCT00498433|Secondary|Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251478|NCT00498433|Primary|Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period||Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251479|NCT00498433|Primary|Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period||Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251480|NCT00498433|Primary|Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period|Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).|Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251481|NCT00498433|Primary|Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251482|NCT00498433|Primary|Part 1: Renin Activity From Plasma During Amlodipine Treatment Period|Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||ng/nl/h||95% Confidence Interval|Geometric Mean
1251483|NCT00498433|Primary|Part 1: Renin Activity From Plasma During Aliskiren Treatment Period|Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||ng/nl/h||95% Confidence Interval|Geometric Mean
1251565|NCT00497146|Secondary|Change in Progression of Thoraco-abdominal Aortic Wall Volume|Change from baseline to Week 48 in thoraco-abdominal aortic wall volume|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters||Standard Error|Least Squares Mean
1251484|NCT00498433|Primary|Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period|Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||pg/mL||95% Confidence Interval|Geometric Mean
1251485|NCT00498433|Primary|Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period|Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||pg/mL||95% Confidence Interval|Geometric Mean
1251486|NCT00498433|Primary|Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||fmol/mL||95% Confidence Interval|Geometric Mean
1251487|NCT00498433|Primary|Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||fmol/mL||95% Confidence Interval|Geometric Mean
1251488|NCT00498433|Primary|Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period|Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98).|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.|||ng/mL||Standard Deviation|Mean
1251489|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period|Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.|||ng/mL||Standard Deviation|Mean
1251490|NCT00498433|Primary|Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period||Day 42|Renin activity and concentration from adipose tissue and skeletal muscles were all below lower limitation of quantification (LLOQ) at all time points.||||||
1251491|NCT00498433|Primary|Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period|Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.|Day 42|More than 50% of the biopsy samples over all time points were either below lower limit of quantification (LLOQ) or not received.||||||
1251492|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period|Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.|||ng/g||Standard Deviation|Mean
1251493|NCT00498433|Primary|Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 98|Due to technical limitations, zero flow concentrations could not be derived for Ang II.||||||
1251494|NCT00498433|Primary|Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 42|Due to technical limitations, zero flow concentrations could not be derived for Ang II.||||||
1251495|NCT00498433|Secondary|Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251496|NCT00498433|Secondary|Part 2: Change From Baseline in Official Blood Pressure||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251497|NCT00498433|Secondary|Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)||Day 14 and Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1251498|NCT00498433|Primary|Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98).|Day 98|Zero flow concentrations from microdialysates could not be derived by linear regression because of missing data due to inadequate sample volumes.||||||
1251566|NCT00497146|Secondary|Change in Progression of Thoraco-abdominal Aortic Plaque Volume|Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters||Standard Error|Least Squares Mean
1251499|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics (PK)/ pharmacodynamics (PD) data were included in the data analysis.|||ng/mL||Standard Deviation|Mean
1251500|NCT00498368|Secondary|Biochemical Marker Immunoglobulin G (IgG) AutoAb at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.|||U/ml||Standard Deviation|Mean
1251501|NCT00498368|Secondary|Biochemical Marker Gd-Immunoglobulin A Subclass 1 (IgA1) at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.|||U/100ng IgA||Standard Deviation|Mean
1251502|NCT00498368|Secondary|Biochemical Marker IgA at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.|||mg/ml||Standard Deviation|Mean
1251503|NCT00498368|Primary|Change in Proteinuria at 12 Months||1 year|The number of participants differs from the participant flow because not all participants had the laboratory test done.|||participants|||Number
1251504|NCT00498355|Secondary|The Incidence of Ocular and Non-ocular Adverse Events||Study duration||||adverse events|||Number
1251505|NCT00498355|Secondary|The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)||Study duration||||uveitis flares|||Number
1251506|NCT00498355|Secondary|The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12||7 days, and at months 3, 6, 9, and 12||||microns||Full Range|Mean
1251507|NCT00498355|Secondary|The Median Change in Best Corrected Visual Acuity From 6 to12 Months||6 to 12 months||||Letters||Full Range|Median
1251508|NCT00498355|Primary|The Mean Change at 3 Months in BSCVA From Baseline|The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters.|baseline and 3 months|6 patients completed all assessment points. One patient decided not to continue for nonmedical reasons, but they did complete the baseline, 1-week and 1-month assessment.|||letters||Full Range|Mean
1251509|NCT00498186|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Up to five years|Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).|||participants|||Number
1251510|NCT00498186|Primary|Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Up to five years|Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).|||participants|||Number
1251511|NCT00498173|Secondary|Change in Pediatric Anxiety Rating Scale, 5-item Total (Open-label Trial)|Since the ABC does not have items which directly assess anxiety, the Pediatric Anxiety Rating Scale (PARS) is administered at week 8 during the study as an exploratory measure. The PARS is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms.Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
1251512|NCT00498173|Secondary|Change in Pediatric Quality of Life Inventory (Open-label Trial)|Quality of life is assessed with the Pediatric Quality of Life Inventory (PedsQL 4.0). This instrument is well-validated and widely used for measuring health-related quality of life in children and adolescents. It also appears to be a valid instrument for use with children with psychiatric disorders. The Generic Core scales include 23 items. The health related and family functioning scores range from 0 to 100, with higher scores indicating better quality of life. The Family Impact module will be included to assess any change in family functioning. This will be completed at the start of the open-label trial and at the end of 8 weeks. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
1251513|NCT00498173|Secondary|Change in Vineland Adaptive Behavior Scales (VABS) Composite Score (Open-label Trial)|The Vineland Adaptive Behavior Scales, Second Edition (VABS) is used to assess adaptive functioning in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. This is a well-standardized open-ended interview used to assess the overall functioning of children and adults. This measure is especially important for subjects with PDDs given that their intellectual level is not always comparable to their adaptive functioning. The Vineland Maladaptive Behavior subscales will be included with these measures as these have been shown to be responsive to drug effects in other clinical trials in this population. The composite score represents a standard score (mean = 100 and standard deviation of 15; range = 20-160) on which higher scores indicate a higher level of adaptive functioning. Change will be determined from the start of the open-label phase to 8 weeks|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
1251567|NCT00497146|Secondary|Change in High Sensitivity C-reactive Protein (hsCRP)|High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milligrams/liter||Standard Error|Least Squares Mean
1251915|NCT00494507|Primary|HYP Attack Rate|The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HYP participants.|8 weeks||||attacks per week||Inter-Quartile Range|Median
1251514|NCT00498173|Secondary|Change in Social Responsiveness Scale (SRS) (Open-label Trial)|The Social Responsiveness Scale (SRS) is completed by the parent in order to assess whether additional improvements in social functioning occur with atomoxetine, as observed in our pilot study. This 65-item questionnaire will be completed at baseline and at the end of 8 weeks. The SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each item is summed to create a total score. Total score results as follows: 0-62: within normal limits; 63-79 mild range of impairment; 80-108: moderate range of impairment; 109-149: severe range of impairment. This 65-item questionnaire will be completed at the start of and at the end of 8 weeks of the open-label trial.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
1251515|NCT00498173|Secondary|Change in Aberrant Behavior Checklist (ABC) (Open-label Trial)|The Aberrant Behavior Checklist (ABC) is a 58-item questionnaire with 5 subscales derived by factor analysis: Irritability, Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate. It has been extensively used in psychopharmacological studies of autism and assesses many symptoms that are either central to autism (Social Withdrawal, Stereotypy, and Inappropriate Speech) or frequently a target of treatment Irritability). Each item of the 58-item scale is scored on a 4-point scale (0=never a problem to 3=severe problem). The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores per subscale are: Social Withdrawal/Lethargy 0-48; Stereotypy 0-21; Irritability 0-45; Hyperactivity 0-48; Inappropriate Speech 0-12. Parent ratings occur every 2 weeks during the study. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Placebo-treated subjects that don’t respond to placebo will be offered an 8-week open-label trial of atomoxetine, and the open-label extension will be a continuation phase for those subjects that respond to 8 weeks of atomoxetine during the double-blind phase.|||units on a scale||95% Confidence Interval|Mean
1251516|NCT00498173|Secondary|Change in ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Open-label Trial)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week open-label phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The score fro each subscale ranges from 0-27, with a higher score indicating greater severity. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
1251517|NCT00498173|Secondary|Change in ADHD Rating Scale (ADHDRS)-Home Version Total Score (Open-label Trial)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range form 0 to 54, with a higher score indicating greater severity. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
1251518|NCT00498173|Secondary|Odds of Clinical Global Impression-Improvement Scale, Very Much or Much Improved (1 or 2) (Randomized Phase)|The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Odds of improvement at 8 weeks were estimated using a repeated measures logistic regression model adjusting for baseline severity, study stratum, and site. The CGI-I was administered biweekly during the study. The CGI was focused on the target symptoms of inattention, hyperactivity, and impulsivity.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.|||odds of improvement||95% Confidence Interval|Number
1251519|NCT00498173|Secondary|Pediatric Anxiety Rating Scale, 5-Item Total (Randomized Phase)|Since the ABC does not have items which directly assess anxiety, the Pediatric Anxiety Rating Scale (PARS) is administered at week 8 during the study as an exploratory measure. The PARS is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
1251520|NCT00498173|Secondary|Pediatric Quality of Life Inventory (Randomized Phase)|Quality of life is assessed with the Pediatric Quality of Life Inventory (PedsQL 4.0). This instrument is well-validated and widely used for measuring health-related quality of life in children and adolescents. It also appears to be a valid instrument for use with children with psychiatric disorders. The Generic Core scales include 23 items. The health related and family functioning scores range from 0 to 100, with higher scores indicating better quality of life. The Family Impact module will be included to assess any change in family functioning. This will be completed at baseline and at the end of 8 weeks. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
1251568|NCT00497146|Secondary|Change in B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||log nanograms/liter||Standard Error|Least Squares Mean
1251521|NCT00498173|Secondary|Vineland Adaptive Behavior Scales (VABS) Composite Score (Randomized Phase)|The Vineland Adaptive Behavior Scales, Second Edition (VABS) is used to assess adaptive functioning in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. This is a well-standardized open-ended interview used to assess the overall functioning of children and adults. This measure is especially important for subjects with PDDs given that their intellectual level is not always comparable to their adaptive functioning. The Vineland Maladaptive Behavior subscales will be included with these measures as these have been shown to be responsive to drug effects in other clinical trials in this population. The VABS will be done at baseline and at the end of 8 weeks. The composite score represents a standard score (mean = 100 and standard deviation of 15; range = 20-160) on which higher scores indicate a higher level of adaptive functioning. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
1251522|NCT00498173|Secondary|Social Responsiveness Scale (SRS) (Randomized Phase)|The Social Responsiveness Scale (SRS) is completed by the parent in order to assess whether additional improvements in social functioning occur with atomoxetine, as observed in our pilot study. This 65-item questionnaire will be completed at baseline and at the end of 8 weeks. The SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each item is summed to create a total score. Total score results as follows: 0-62: within normal limits; 63-79 mild range of impairment; 80-108: moderate range of impairment; 109-149: severe range of impairment. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
1251523|NCT00498173|Secondary|Aberrant Behavior Checklist (ABC) (Randomized Phase)|The Aberrant Behavior Checklist (ABC) is a 58-item questionnaire with 5 subscales derived by factor analysis: Irritability, Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate. It has been extensively used in psychopharmacological studies of autism and assesses many symptoms that are either central to autism (Social Withdrawal, Stereotypy, and Inappropriate Speech) or frequently a target of treatment (Irritability). Each item of the 58-item scale is scored on a 4-point scale (0=never a problem to 3=severe problem). The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores per subscale are: Social Withdrawal/Lethargy 0-48; Stereotypy 0-21; Irritability 0-45; Hyperactivity 0-48; Inappropriate Speech 0-12. Parent ratings occur every 2 weeks during the study. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
1251524|NCT00498173|Secondary|ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Randomized Phase)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The score for each subscale ranges from 0-27 with a higher score indicating greater severity. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
1251525|NCT00498173|Primary|ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range form 0 to 54, with a higher score indicating greater severity. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
1251526|NCT00497874|Secondary|Change in Physical Functioning|Physical functioning was assessed using the Physical Functioning, Role Functioning, Health Perceptions, and Pain subscales of the 20-item Medical Outcomes Study Short Form survey (SF-20) (Stewart, Hays, & Ware, Jr., 1988). (SF-20 subscales assessing mental health and social functioning were omitted to get a purer measure of physical functioning). Physical functioning was computed by taking the mean of the four subscales after each was linearly transformed to range from 0-100. The change scores reported here are the difference between the physical functioning scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -100 to +100, with higher positive scores indicating more improvement in physical functioning.|Baseline, 9 months|Multiple imputation|||units on a scale||Standard Deviation|Mean
1251527|NCT00497874|Secondary|Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)|At 9 months follow-up, participants who had been prescribed antidepressant medication were asked if they had started and were still taking it. Participants who were taking their medication or had stopped with their doctor's advice were considered to be adherent.|9 months|Multiple imputation|||Participants|||Number
1251528|NCT00497874|Secondary|Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up|At baseline and follow-up, Major Depression was assessed using 9-item depression module of the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire—PHQ-9 (Spitzer, Kroenke, & Williams, 1999). In this analysis, Major Depression was assessed among participants not meeting criteria for major depression at baseline.|9 months|Multiple imputation|||Participants|||Number
1251569|NCT00497146|Secondary|Change in Troponin-T|Troponin-T is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||micrograms/liter||Standard Error|Least Squares Mean
1251529|NCT00497874|Secondary|Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.|Depression prevention was defined as: “Using effective methods to keep depression from occurring, or if it does occur, to keep it as mild and brief as possible.” Effective methods were: 1) controlling negative thinking; 2) engaging in healthy, pleasant activities; 3) practicing stress management; 4) exercising; and 5) getting professional help when needed. Patients who reported that they were not currently practicing depression prevention and had no intention of doing so in the next 6 months were classified in the precontemplation stage; those who intended to practice depression prevention in the next 6 months or next 30 days were classified in the contemplation or preparation stage, respectively; those who had been practicing depression prevention for less than 6 months were in the action stage, and those who had been practicing for more than 6 months were in maintenance. This outcome represents the number of participants in the action or maintenance stage at 9 months follow-up.|9 months|Multiple imputation|||Participants|||Number
1251530|NCT00497874|Secondary|Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity|Two statistical criteria (Jacobson & Truax, 1991a; Atkins, Bedics, McGlinchey, & Beauchaine, 2005) were used to define reliable and clinically significant improvement. The first involved selecting a cutoff that represents remission or the absence of symptoms, which was selected to be BDI-II < 9. The second involved selecting a pre-post difference score that represents a statistically reliable change (e.g., how much change—1 point, 5 points, 10 points—is needed to be 95% confident that a real change has occurred, rather than just a chance fluctuation due to the unreliability of the measure?) Using a general formula for calculating reliable change that incorporates test-retest reliability (Jacobson & Truax, 1991b), reliable change for the BDI-II was calculated to be 5.13, and rounded down to 5. Thus, reliable and clinically significant improvement on the BDI-II was defined as a reduction of 5 or more points from baseline to follow-up and a follow-up score < 9.|9 months|Multiple imputation|||Participants|||Number
1251531|NCT00497874|Primary|Change in Depression Severity|Depression was assessed using the Beck Depression Inventory, 2nd Edition (BDI-II)(Beck, Steer, & Brown, 1996). In this self-report measure, 21 symptoms of depression are rated on a 0-3 scale. Scores for the 21 items are summed to yield a total score ranging from 0 to 63. The change scores reported here are the difference between the total BDI-II scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -63 to +63, with larger negative scores indicating greater reduction in depression.|Baseline, 9 months|Multiple imputation|||units on a scale||Standard Deviation|Mean
1251532|NCT00497796|Secondary|Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment|For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of VP 44469 (a metabolite of maribavir) concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for VP 44469 was 0.2 μg/mL.|12 hours post-dose after 2, 6, and 10 weeks of treatment|The PK population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.|||μg/mL||Standard Deviation|Mean
1251533|NCT00497796|Secondary|Plasma Concentration of Maribavir During Treatment|For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of maribavir concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for maribavir was 0.2 μg/mL.|12 hours post-dose after 2, 6, and 10 weeks of treatment|The Pharmacokinetic (PK) population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.|||μg/mL||Standard Deviation|Mean
1251534|NCT00497796|Secondary|Percent of Participants With Signs of Bone Marrow Suppression|Bone marrow suppression was assessed by the occurrence of adverse events (AEs) of investigator-reported leukopenia, neutropenia, thrombocytopenia, and pancytopenia; absolute neutrophil count (ANC) <1000/mm3; white blood cell (WBC) count toxicity grade shifts from 0-2 at baseline to a maximum of 3-4 post-baseline; and use of hematopoietic growth factors during the 6 month post-transplant period.|15 weeks|The ITT-S population, defined as all participants who received at least one dose of study drug.|||percent of participants|||Number
1251535|NCT00497796|Secondary|Number of Participants Who Died Within 6 Months Post-Transplantation||6 months post-transplant|The ITT-S population, defined as all participants who received at least one dose of study drug.|||participants|||Number
1251536|NCT00497796|Secondary|Number of Participants With Acute Graft Rejection|Rejection was assessed by examining a liver biopsy sample. Diagnosis of graft rejection included a global assessment grade and a rejection activity index score.|26 weeks post-transplant|The ITT-S population, defined as all participants who received at least one dose of study drug.|||participants|||Number
1251537|NCT00497796|Secondary|Number of Participants With Graft Failure Related Death||Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)|The ITT-S population, defined as all participants who received at least one dose of study drug.|||participants|||Number
1251538|NCT00497796|Secondary|Number of Participants With Retransplantation||Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)|The ITT-Safety (ITT-S) population, defined as all participants who received at least one dose of study drug.|||participants|||Number
1251539|NCT00497796|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation|Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.|100 days post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||participants|||Number
1251540|NCT00497796|Secondary|Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|100 days post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||participants|||Number
1251541|NCT00497796|Secondary|Number of Participants With Investigator-determined CMV Disease|Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant)|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||participants|||Number
1251542|NCT00497796|Secondary|Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by pp65 Antigenemia or CMV DNA PCR from a central or local lab. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||days||Inter-Quartile Range|Median
1251543|NCT00497796|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation|Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.|6 months post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||participants|||Number
1251544|NCT00497796|Primary|Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The modified Intent-to-Treat (ITT-M) population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||number of participants with event|||Number
1251545|NCT00497770|Secondary|Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)|The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment.|Baseline and end of treatment (up to 20 cycles [14 months])|The number of participants who had measurements for the subscale at those time points.|||participants||Standard Deviation|Mean
1251546|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone|The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
1251547|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping|The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
1251570|NCT00497146|Secondary|Change in Interleukin-6 (IL-6)|Interleukin-6 (IL-6) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||nanograms/liter||Standard Error|Least Squares Mean
1251548|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications|The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
1251549|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities|The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
1251550|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances|The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
1251551|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation|The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
1251552|NCT00497770|Secondary|Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals|The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
1251553|NCT00497770|Secondary|Progression Free Survival|Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method.|baseline to measured progressive disease or death (up to 20 cycles [14 months])|All participants enrolled in the study.|||months||95% Confidence Interval|Median
1251554|NCT00497770|Secondary|Overall Survival|Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 20 cycles [14 months])|All participants enrolled in the study.|||months||95% Confidence Interval|Median
1251555|NCT00497770|Primary|Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)|Disease Control Rate [DCR] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.|baseline to measured progressive disease (up to 20 cycles [14 months])|"Of the 434 participants enrolled, 50 participants had a response status at the end of pemetrexed treatment indicating Not done/Missing and were not included in this analysis."|||percentage of participants|||Number
1251556|NCT00497198|Primary|Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12||12 weeks (baseline to week 12)|Per protocol set; Last observation carried forward|||percentage||Standard Error|Mean
1251557|NCT00497198|Primary|Hemoglobin A1c (HbA1c) at Baseline||0 weeks|Per protocol set|||percentage||Standard Deviation|Mean
1251558|NCT00497198|Primary|Change From Baseline in Blood Glucose at Week 12||12 weeks (baseline to week 12)|Per protocol set; Last observation carried forward|||mg/dL||Standard Error|Mean
1251559|NCT00497198|Primary|Fasting Plasma Glucose at Baseline||0 weeks|Per protocol set|||mg/dL||Standard Deviation|Mean
1251560|NCT00497198|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12||12 weeks (baseline to week 12)||||mg/dL||Standard Error|Mean
1251561|NCT00497146|Secondary|Change in Progression of Left Ventricular Ejection Fraction|Change from baseline to Week 48 in left ventricular ejection fraction.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||percent||Standard Error|Least Squares Mean
1251562|NCT00497146|Secondary|Change in Progression of Left Ventricular End-diastolic Volume Index|Change from baseline to Week 48 in left ventricular end-diastolic volume index.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters/meter^2.7||Standard Error|Least Squares Mean
1251563|NCT00497146|Secondary|Change in Progression of Left Ventricular End-systolic Volume Index|Change from baseline to Week 48 in left ventricular end-systolic volume index.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters/meter^2.7||Standard Error|Least Squares Mean
1251564|NCT00497146|Secondary|Change in Progression of Aortic Compliance|Change from baseline to Week 48 in aortic compliance.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||10^-4 cm^2/mmHg||Standard Error|Least Squares Mean
1251574|NCT00497146|Secondary|Change in E-wave Deceleration Time (DT)|E-wave deceleration time (DT) is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||seconds||Standard Error|Least Squares Mean
1251575|NCT00497146|Secondary|Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')|The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||ratio||Standard Error|Least Squares Mean
1251576|NCT00497146|Secondary|Change in Diastolic Mitral Annular Relaxation Velocity (E')|Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||centimeters/second||Standard Error|Least Squares Mean
1251577|NCT00497146|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)|The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)^2.7.|Baseline to 48 weeks|The analysis was based on the intent-to-treat (ITT) population, defined as all randomized participants who took at least one dose of study drug, with available data.|||grams/meter^2.7||Standard Error|Least Squares Mean
1251578|NCT00497081|Primary|Frequency of Adverse Events Reported||From Baseline (week 0) through Final Visit (week 12)||||Adverse Events Reported|||Number
1251579|NCT00497081|Primary|Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.|Proportion of days with recorded pill bottle opening, as determined by MEMS (medication event monitoring system).|Daily, from Baseline (week 0) through Final Visit (week 12)||||Percentage of recorded openings||Standard Deviation|Mean
1251580|NCT00497081|Primary|Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).||Baseline (week 0) and Final Visit (week 12)||||Percentage reduction|||Number
1251581|NCT00497055|Primary|To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.||Total reported adverse events (throughout study, up to 12 weeks)||||total reported adverse events|||Number
1251582|NCT00497055|Primary|To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.|To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps [MEMS or Medication Event Monitoring System]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.)|Adherence as determined by MEMS (throughout study, up to 12 weeks)||||percent adherence from MEMS||Standard Deviation|Mean
1251583|NCT00497055|Primary|To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.|To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group.|Final study visit at week 12||||perc of positive urines at final visit|||Number
1251584|NCT00496964|Secondary|Muscle Activation During Maximal Contractions and Fatigue Contractions|muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees|4, 6, 12 weeks||||ratio VMO EMG to VL EMG||Standard Deviation|Mean
1251585|NCT00496964|Secondary|Knee Extensor Fatigue|This is not available due to data collection errors|4, 6, 12 weeks|This is not available due to data collection errors||||||
1251586|NCT00496964|Secondary|Maximal Knee Extensor Force During Concentric and Isometric Contractions||4, 6, 12 weeks||||Nm||Standard Deviation|Mean
1251587|NCT00496964|Primary|Lower Extremity Functional Scale|The lower extremity functional scale (LEFS) is a self report questionnaire. Subjects rate 19 items related to general activities that require the lower extremities on a scale of 0 - 4. 0 = extreme difficulty or unable to perform the activity, 4 = No difficulty performing the activity. The total of all rankings are summed and divided by the maximum score (76). The score is reported as a percentage. 100% = no difficulty in performing any of the tasks. 0% = extreme difficulty or unable to perform all of the tasks.|4, 6, 12 weeks|No statistical analysis due to small number of subjects|||percentage of total possible score||Standard Deviation|Mean
1251588|NCT00496964|Primary|Functional Index Questionnaire|The Functional Index Questionnaire (FIQ) is a self report functional rating scale. Individuals rate eight-activities. Each activity is rated from 0 - 2 with ) being unable to perform the activity and 2 being able to perform the activity without difficulty. The total score is summed for a final score of 0 - 16. 0 indicates that the individual is ubable to perform any of the tasks, 16 indicates that the subject is able to perform all tasks without difficulty. The eight items include: walking (1 block and 1 mile), climbing stairs (2 flights and 4 flights), squatting, kneeling, prolonged sitting, and running|4, 6, 12 weeks|No statistical analysis due to small number of subjects|||units on a scale||Standard Deviation|Mean
1251589|NCT00496964|Primary|Change in Anterior Knee Pain Scale.|"Anterior Knee Pain Scale: a 13-item questionnaire; a TOTAL score of 0 = severe disability; a score of 100 = no pain or disability. (items are scored 0-5 or 0-10).~Change scores at 12 wks are reported. Inverted so positive values reflect improvement.~Included items: difficulty with: weight bearing, walking, stairs, squat, run, jump, prolonged sitting; presence of limp, swelling, patellar subluxation, atrophy of thigh, reduced knee flexion. Reference: Kujala et al: Scoring of Patellofemoral Disorders. J Arthroscopic Rel Surg, 9(2)159-163, 1993"|4, 6, 12 weeks|The Anterior Knee Pain Scale is a 13-item questionnaire; a score of 0 = severe disability; a score of 100 = no pain or disability. Change scores are reported. Positive values = improvement in symptoms.|||Units on Scale||Standard Deviation|Mean
1251590|NCT00496964|Primary|Visual Analog Scale Pain Ratings (VAS)|Visual Analog Scale pain rating (VAS). 10 cm line with anchors at 0 (no pain) and 10 cm (worst imaginable pain). Scores are in cm (0 - 10) 0 no pain, higher values greater pain. Results given are for change at 12 weeks compared to baseline (week 12 score - baseline score)|4, 6, 12 weeks|analysis per protocol. Drop out not included in analysis. mean reduction in Visual Analog Scale for Pain (VAS) from start to 12 weeks.|||cm||Standard Deviation|Mean
1251591|NCT00496873|Secondary|3-Year Progression-Free Survival|Progression-free survival (PFS) was defined as time from initiation of therapy to progression of disease or death, whichever occurred first. The Kaplan-Meier method was used to estimate PFS.|PFS assessed 7 days prior to every cycle and then every 3 months after off-treatment for one year, every 6 months for second year, then once on third year|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1251592|NCT00496873|Primary|Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy|Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy.|9 cycles of 21 days, up to 7 months|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.|||participants|||Number
1251593|NCT00496873|Primary|Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999|Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease.|Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.|||Percentage of Participants|||Number
1251594|NCT00496860|Secondary|Immunogenicity of ALT-801|Titer of anti-drug Abs at week 4|24 months||||titer||Standard Error|Mean
1251595|NCT00496860|Secondary|ALT-801 Induced Cell-mediated Immune Responses|Number of tumor-responsive (interferon-gamma positive (IFNg+)) immune cells in blood post dosing|24 months||||IFNg spots per million PMBCs||Standard Error|Mean
1251596|NCT00496860|Secondary|Clinical Antitumor Response to ALT-801|Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD). CR is defined as disappearance of all tumor lesions selected for measurement. PR is defined as at least 30% decrease in the sum of all tumor lesions selected for measurement. Stable disease is defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for progressive disease (PD) which is defined as at least 20% increase the sum of the all tumor lesions selected for measurement.|24 months||||participants|||Number
1251597|NCT00496860|Primary|The Maximum-tolerated Dose (MTD) of ALT-801|Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.|18 months||||events|||Number
1251598|NCT00496860|Primary|The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies|Number of serious adverse events per cohort|18 months||||Events|||Number
1251599|NCT00496834|Secondary|Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug||Baseline and 24 weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.|||mm Hg||Standard Deviation|Mean
1251600|NCT00496834|Secondary|Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug||Baseline and 24 weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.|||mm Hg||Standard Deviation|Mean
1251601|NCT00496834|Primary|PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug|Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.|Baseline and 24 Weeks|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). Missing data were imputed by the last observation carried forward (LOCF) technique. For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.|||meters/second||Standard Deviation|Mean
1251602|NCT00496834|Primary|Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug|Analysis was performed in the modified intention to treat (mITT) population.|Baseline and 24 Weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94). Missing data were imputed by the last observation carried forward (LOCF) technique.|||meters/second||Standard Deviation|Mean
1251603|NCT00496808|Secondary|Mean Percent of Ki-67|Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.|Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks|Analysis was per protocol. Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.|||Percentage of Ki-67||Standard Deviation|Mean
1251604|NCT00496808|Primary|Number of Participants Achieving Documented Change in Proliferation|Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student’s t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.|Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks|Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.|||Participants|||Number
1251605|NCT00496808|Primary|Percent Change in Proliferation as Measured by Ki-67|Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.|Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks|||||||
1251606|NCT00496782|Secondary|Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc||Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||Gene Sequence|||Number
1251607|NCT00496782|Secondary|Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24|Change in gene sequence in gp-160, and the V3 loop from Screening visit (Day -21 to 0) to Day 14, time of virologic failure (See Section 6.5.1) and Week 24|Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||Gene Sequence|||Number
1251608|NCT00496782|Secondary|Number of Subjects With Susceptibility to Maraviroc|Phenotypic susceptibility to maraviroc|Screening (Day -21 to 0), Day 14, Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||Participants|||Number
1251609|NCT00496782|Secondary|Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening|Change in detectable resistance (genotype) and susceptibility (phenotype) to drugs in the regimen from Screening|Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure.|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||Gene Sequence|||Number
1251610|NCT00496782|Secondary|Change in Detectable Tropism From Baseline|Number of subjects who switch their tropism status from Baseline to Days 7, 14, and Week 24/End of Study(EOS)/Discontinuation|Baseline, Day 15 and Week 24/End of Study/Discontinuation|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||Participants|||Number
1251611|NCT00496782|Secondary|Change in Detectable Tropism From Screening|Number of subjects who switch their tropism status from screening to Baseline|Screening (Day -21 to 0), Baseline.|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||Participants|||Number
1251612|NCT00496782|Secondary|Change in Lymphocyte Subsets; CD4 and CD8 From Screening.|Calculated avergae of {CD4 or CD8 at Day 1 - CD4 or CD8 at Screening}|Screening (Day -14 to 0), Day 1.|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||cells/µL||Standard Deviation|Mean
1251613|NCT00496782|Secondary|Change in Lymphocyte Subset CD8 From Day 1|Calculated average of CD8 at Day 7, 14, 28 and Week 24 minus CD8 at Day 1|Day 1(Baseline), Day 7, 14, 28 and Weeks 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||cells/µL||Standard Deviation|Mean
1251614|NCT00496782|Primary|Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay|Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism|Baseline, Day 4, 7, 14|Study was canceled: no efficacy data (primary/secondary) was collected per protocol for limited number of patients left in study; only safety data was summarized.|||percentage of participants|||Number
1251615|NCT00496782|Secondary|Change in Lymphocyte Subset CD4 From Baseline|Calculated average of CD4 at Day 7, 14, 28 and Week 24 minus CD4 at Day 1|Day 1 (Baseline), Day 7, 14, 28 and Weeks 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||cells/µL||Standard Deviation|Mean
1251616|NCT00496782|Secondary|Time to Virologic Failure|For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||Days||Standard Deviation|Median
1251617|NCT00496782|Secondary|Subjects With Virologic Failure|For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||participants|||Number
1251618|NCT00496782|Secondary|Subjects Achieving HIV-1 RNA <50 Copies/mL|Number of Subjects Achieving HIV-1 RNA <50 Copies/mL at each time point|Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||participants|||Number
1251619|NCT00496782|Secondary|Subjects Achieving HIV-1 RNA <400 Copies/mL|Number of Subjects Achieving HIV-1 RNA <400 Copies/mL at each time point|Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.|||participants|||Number
1251773|NCT00495755|Secondary|The Effect of Alemtuzumab Therapy on Parameters of Cellular and Humoral Immunity in the Late Post Transplant Period. This Information is Exploratory in Nature Only Due to the Heterogeneity of the Anticipated Patient Population.||12|||||||
1251620|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)|ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable|||Participants|||Number
1251621|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable|||Participants|||Number
1251622|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality|BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable|||Participants|||Number
1251623|NCT00496769|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug.|||Participants|||Number
1251624|NCT00496769|Secondary|Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm.|Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.|||Percentage of events per year|||Number
1251625|NCT00496769|Secondary|Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period|Event rate=percent of participants with an event divided by the total participants in the arm.|First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010|Participants who received at least 1 dose of study drug.|||Percentage of events per year|||Number
1251626|NCT00496769|Secondary|Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death|Event rate=percent of participants with an event divided by the total participants in the arm.|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.|||Percentage of events per year|||Number
1251627|NCT00496769|Secondary|Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm.|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.|||Percentage of events per year|||Number
1251628|NCT00496769|Primary|Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.|||Percentage of events|||Number
1251803|NCT00495521|Secondary|Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks||4 weeks|||||||
1251804|NCT00495521|Secondary|Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks||4 weeks|||||||
1251629|NCT00496730|Other Pre-specified|Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.||Baseline and Week 8|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.|||mg/dL||Standard Deviation|Mean
1251630|NCT00496730|Secondary|Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.|"Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.~LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk)."|Baseline and 8 weeks|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.|||Participants attaining LDL-C goal|||Number
1251631|NCT00496730|Primary|Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.||Baseline and 8 Weeks|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.|||Percent of Baseline Value||Standard Deviation|Mean
1251632|NCT00496626|Secondary|Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination|All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination|Safety population, defined as all participants who were vaccinated at least one dose and had safety follow-up data|||Participants|||Number
1251633|NCT00496626|Secondary|Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7|"Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively.~Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7"|Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7|Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.|||Participants|||Number
1251634|NCT00496626|Primary|Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)|"Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array.~The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) <7, <8, <11, <10 respectively)"|Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7|Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.|||mMU/mL||95% Confidence Interval|Geometric Mean
1251635|NCT00496587|Secondary|Objective Response Rate (ORR)|Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: >30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started.|12 months or until progression of disease|Four participants were excluded from response analysis due to missing data.|||percentage of participants|||Number
1251636|NCT00496587|Primary|Time to Treatment Failure (TTF)|Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.|12 months or until progression of disease|Four participants were excluded from response analysis due to missing data.|||Months||95% Confidence Interval|Median
1251637|NCT00496587|Primary|Progression Free Survival (PFS)|Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.|12 months or until progression of disease|One participant was excluded from survival analysis due to missing data.|||Months||95% Confidence Interval|Median
1251638|NCT00496483|Secondary|Safety Evaluation|A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.|52 days|All enrolled patients are included in the safety population.|||participants|||Number
1251702|NCT00496340|Primary|Incidence of Greater Than or Equal to 50% Donor Chimerism|The primary endpoint was achievement of >/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT).|28 days post-transplant|All participants|||percentage of participants|||Number
1251639|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.|Degree og fluctuation and degree of swing was measured as baseline at day 7 (Cmin was measured as part of the primary outcome).|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~Arithmetic mean and standard deviation is given below."|||percentage||Standard Deviation|Mean
1251640|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.|Tmax was measured at baseline day 7 (Cmin was measured as part of the primary outcome).|7 days|48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.|||hour||Full Range|Mean
1251641|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.|Cmax and Cavg was measured at baseline day 7 (Cmin was measured as part of the primary outcome).|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
1251642|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."|||ng*hr/mL||Standard Deviation|Mean
1251643|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
1251644|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."|||ng*hr/mL||Standard Deviation|Mean
1251645|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Trough Levels (C24).|Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
1251646|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.|Degree og fluctuation and degree of swing was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~Arithmetic mean and standard deviation is given below."|||percentage||Standard Deviation|Mean
1251647|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.|Tmax was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.|||hour||Full Range|Mean
1251648|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.|Cmax and Cavg was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
1251649|NCT00496470|Secondary|Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
1251650|NCT00496470|Secondary|Serum Tumor Necrosis Factor-alpha (TNF-alpha)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
1251651|NCT00496470|Secondary|Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
1251652|NCT00496470|Secondary|Serum Monocyte Chemoattractant Protein-1 (MCP-1)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
1251653|NCT00496470|Secondary|Serum Interleukin 8 (IL-8)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
1251654|NCT00496470|Secondary|Serum Interleukin 6 (IL-6)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
1251655|NCT00496470|Secondary|Serum High-sensitivity C-reactive Protein (hsCRP)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
1251805|NCT00495521|Secondary|Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary||up to 4 weeks|||||||
1251806|NCT00495521|Secondary|Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks||4 weeks|||||||
1251656|NCT00496470|Secondary|Severe COPD Exacerbations|Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation|12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Participants|||Number
1251657|NCT00496470|Secondary|COPD Symptoms, Cough Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Units on a Scale||Standard Deviation|Mean
1251658|NCT00496470|Secondary|COPD Symptoms, Chest Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Units on a Scale||Standard Deviation|Mean
1251659|NCT00496470|Secondary|COPD Symptoms, Sleeping Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Units on a Scale||Standard Deviation|Mean
1251660|NCT00496470|Secondary|COPD Symptoms, Breathing Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Units on a Scale||Standard Deviation|Mean
1251661|NCT00496470|Secondary|Use of Rescue Medication, Total|Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Inhalations||Standard Deviation|Mean
1251662|NCT00496470|Secondary|Use of Rescue Medication, Day|Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Inhalations||Standard Deviation|Mean
1251663|NCT00496470|Secondary|Use of Rescue Medication, Morning|Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Inhalations||Standard Deviation|Mean
1251664|NCT00496470|Secondary|Use of Rescue Medication, Night|Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Inhalations||Standard Deviation|Mean
1251665|NCT00496470|Secondary|Capacity of Day Living in the Morning (CDLM) Score|"Daily diary record. Change in average values from run-in to the full treatment period.~The CDLM questionnaire is as a questionnaire to report on patient’s ability to carry out each of six different morning activities (score ranging from 0 “not performed” to 1”performed”) and rank the difficulty of performing each of those activities (score ranging from 0 “so difficult that the activity could not be carried out by the patient on their own” to 5 “activity was not at all difficult to carry out”. Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1251666|NCT00496470|Secondary|GCSQ Score, 15 Minutes Post-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
1251667|NCT00496470|Secondary|GCSQ Score, 5 Minutes Post-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1251668|NCT00496470|Secondary|Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1251807|NCT00495521|Secondary|Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks||4 weeks|||||||
1251669|NCT00496470|Secondary|Morning Diary FEV1, 15 Minutes Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251670|NCT00496470|Secondary|Morning Diary FEV1, 5 Minutes Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251671|NCT00496470|Secondary|Evening Diary FEV1, Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251672|NCT00496470|Secondary|Morning Diary FEV1 Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251673|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) 15 Min Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
1251674|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) 5 Min Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
1251675|NCT00496470|Secondary|Evening Peak Expiratory Flow (PEF) Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
1251676|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
1251677|NCT00496470|Secondary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score|"Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).~SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life."|Baseline and 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Score on a scale||Standard Deviation|Mean
1251678|NCT00496470|Secondary|Inspiratory Capacity (IC) 60 Minutes Post-dose|Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251679|NCT00496470|Secondary|Inspiratory Capacity (IC) Pre-dose|Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251680|NCT00496470|Secondary|Forced Vital Capacity (FVC) 60 Minutes Post-dose|Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251681|NCT00496470|Secondary|Forced Vital Capacity (FVC) 5 Minutes Post-dose|Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251682|NCT00496470|Secondary|Forced Vital Capacity (FVC) Pre-dose|Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251683|NCT00496470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose|Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251808|NCT00495521|Secondary|Rate of Remission|Rate of remission was defined by a decrease in modified Crohn's Disease Activity Index (mCDAI) > 100 points and total mCDAI < 150 by 4 weeks|4 weeks||||Participants|||Count of Participants
1251684|NCT00496470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose|Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251685|NCT00496470|Primary|Forced Expiratory Volume in 1 Second (FEV1) Pre-dose|Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1251686|NCT00496379|Secondary|Clinical Benefit Rate.|CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease|2 years|all pts who received at least 1 dose of protocol therapy|||percentage of participants|||Number
1251687|NCT00496379|Secondary|Time to Progression at Any Site.|Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0|2 years|all patients who received at least 1 dose of protocol therapy|||months||Full Range|Median
1251688|NCT00496379|Secondary|Objective Response Rate in Non-Central Nervous System (CNS) Sites|Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease|2 years|only included the 8 pts with measurable non-CNS disease at baseline. The 7 pts with non-measurable non-CNS disease at baseline were not included in the denominator for this endpoint|||percentage of participants|||Number
1251689|NCT00496379|Secondary|Number of Subjects With Adverse Events (Any Grade)|Adverse events per NCI CTCAE|2 years|Study was closed prior to full accrual for reasons detailed in published manuscript|||participants|||Number
1251690|NCT00496379|Primary|Objective Response Rate in the Central Nervous System (CNS)|Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.|2 years|The study was closed prior to full accrual as detailed in the manuscript|||percentage of participants||95% Confidence Interval|Number
1251691|NCT00496366|Secondary|-Determine the Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease for at Least 6 Months) of Capecitabine and Lapatinib. -Determine Time to Disease Progression After Treatment With Capecitabine and Lapatinib. -Evaluate Overall||2 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||||||
1251692|NCT00496366|Primary|Determine the Response Rate (as Determined by RECIST Criteria) of Capecitabine and Lapatinib as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer That Overexpress HER2.||2 years|Study to was terminated early and insufficient data was collected to assess this outcome measure.||||||
1251693|NCT00496340|Secondary|Percentage of Participants With Overall Survival (OS)|OS at 2 years post-transplant. OS, defined as time from day of hematopoietic cell infusion to death from any cause.|2 years post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1251694|NCT00496340|Secondary|Percentage of Participants With Progression Free Survival (PFS)|PFS at 2 years post-transplant. PFS, defined as time from day of hematopoietic cell infusion to disease relapse. Relapsed disease: Disease was in complete remission post-transplant but returned (e.g., >5% blast in bone marrow or any peripheral blasts).|2 years post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1251695|NCT00496340|Secondary|Incidence of Graft Versus Host Disease (GVHD)|"By day +100, the cumulative incidence of GVHD, acute of grades 2-4, and 3-4.~At 2 years, the cumulative incidence of chronic GVHD of any severity according to National Institutes of Health (NIH) consensus criteria. Diagnosis of chronic GVHD requires the presence of at least one diagnostic clinical sign of chronic GVHD or the presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD.~At 2 years, the cumulative incidence of moderate/severe chronic GVHD."|Up to 2 years post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1251696|NCT00496340|Secondary|Time to Incidence of Graft Versus Host Disease (GVHD)|"The median time from allo-HCT to the initiation of tacrolimus (TAC) taper.~The median time to onset of acute GVHD (aGVHD). Clinical manifestations of acute GVHD include a classic maculopapular rash; persistent nausea and/or emesis; abdominal cramps with diarrhea; and a rising serum bilirubin concentration."|Up to 2 years post-transplant|All participants|||days||95% Confidence Interval|Median
1251697|NCT00496340|Secondary|Incidence of Infections|Infections: Incidence of infections (opportunistic and non-opportunistic) following conditioning.|Up to 2 years post-transplant|All participants|||participants|||Number
1251698|NCT00496340|Secondary|Non-relapse Mortality Rate (NRM)|The cumulative incidence of NRM after allo-HCT.|Up to 2 years post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1251699|NCT00496340|Secondary|Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100|Median Percentage of Donor Cells in Study Population (Chimerism).|100 days post-transplant|Participants with bone marrow chimerism data available at time of analysis.|||percentage of cells||95% Confidence Interval|Median
1251700|NCT00496340|Secondary|Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28|Median Percentage of Donor Cells in Study Population (Chimerism).|28 days post-transplant|Participants with bone marrow chimerism data available at time of analysis.|||percentage of cells||95% Confidence Interval|Median
1251701|NCT00496340|Secondary|Cumulative Incidence of Hematopoietic Cell Engraftment|Hematologic engraftment: defined as time to achieve an absolute neutrophil count (ANC) >/= 500/µl for 3 consecutive days or a platelet count of >/= 20,000//µl without the need for platelet support.|28 days post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1251809|NCT00495521|Primary|Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline|Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of >70 points by 4 weeks after randomization compared with baseline|4 weeks||||participants|||Number
1251703|NCT00496262|Secondary|Classical In Vivo Recovery (IVR)|Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose|Pre-infusion to 4 hours post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||% of expected increase in fibrinogen||Full Range|Median
1251704|NCT00496262|Secondary|Incremental In Vivo Recovery (IVR)|Maximum fibrinogen activity increase in plasma per mg/kg dosed|Pre-infusion to 4 hours post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||mg/dL increase per mg/kg body weight||Full Range|Median
1251705|NCT00496262|Secondary|Volume of Distribution at Steady State (Vss)|Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||mL/kg||Standard Deviation|Mean
1251706|NCT00496262|Secondary|Mean Residence Time (MRT)|MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||hours||Standard Deviation|Mean
1251707|NCT00496262|Secondary|Clearance (Cl)|Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||mL/hour/kg||Standard Deviation|Mean
1251708|NCT00496262|Secondary|Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose|AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||hour*mg/mL||Standard Deviation|Mean
1251709|NCT00496262|Secondary|Maximum Concentration (Cmax)|Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||g/L||Standard Deviation|Mean
1251710|NCT00496262|Secondary|Terminal Elimination Half-life (t1/2)|t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|0.5 hours to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||hours||Standard Deviation|Mean
1251711|NCT00496262|Primary|Maximum Clot Firmness (MCF)|MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.|Pre-infusion and 1 hour post-infusion|All subjects in the intention to treat (ITT) population. The ITT population included all subjects who received any portion of any infusion of human fibrinogen concentrate. (Note: 2 subjects in the ITT population had missing MCF data; the change from baseline MCF was entered as 0.0 for these subjects.)|||millimeters||Standard Deviation|Mean
1251712|NCT00496197|Secondary|Number of Participants Who Died||Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set|||participants|||Number
1251713|NCT00496197|Secondary|Number of Participants With Non-serious and Serious Adverse Events|AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect.|Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set. An event may have been reported as both a serious and non-serious adverse event, however, what is presented are distinct events; participants may be counted as having experienced > 1 event.|||participants|||Number
1251714|NCT00496197|Secondary|Number of Participants Per Specified Cause of Death|Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with > 1 cause of death if multiple causes were present.|Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set is the same as the Intent-to-Treat population (ITT) and includes all participants who had taken at least 1 dose of study medication. N=number of participants who died with cause of death reported as Serious Adverse Events.|||participants|||Number
1251715|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)|Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture.|Baseline up to End of Treatment (Day 5 up to Day 42)|Intent to Treat (ITT) population includes all participants who received at least 1 dose of study medication.|||days||Standard Deviation|Mean
1251716|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)|Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).|||days||Standard Error|Mean
1251717|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)|Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to 6 Week Follow-up (EOS)|MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).|||days||Standard Error|Mean
1251718|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)|Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to 6 Week Follow-up (EOS)|MITT; N=number of participants with analyzable data at observation. Time to dischargeable and time to discharge censored at Week 6 Follow-up (EOS).|||days||Standard Error|Mean
1251719|NCT00496197|Secondary|Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species|Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was > 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture.|Baseline (Day 1) up to Week 6 Follow-up (EOS)|MITT; Confidence interval (CI) for the median could not be calculated by the software because no event time met the criteria for inclusion into the CI.|||days||95% Confidence Interval|Number
1251720|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 6 Follow-up (EOS)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251721|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 2 Follow-up|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251722|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251723|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251724|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|Week 6 Follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251725|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|Week 6 follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251736|NCT00496080|Secondary|Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores|"Number of participants categorized as better in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. Better was defined as a change of -11 or less from baseline at 12 mo."|From baseline to 12 months|ITT (No data for 18 participants.)|||participants|||Number
1251851|NCT00495157|Primary|Time to Treatment Failure (Measured in Days)||Measured during the 36-week treatment period|All participants were followed for time to treatment failure or right censoring (measured in days).|||days||Standard Error|Mean
1251726|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 6 Follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251727|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|Week 2 Follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251728|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|Week 2 follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251729|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 2 Follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251730|NCT00496197|Secondary|Number of Participants With Microbiological Response at EOIV|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251731|NCT00496197|Secondary|Number of Participants With Clinical Response at EOIV|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251732|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251733|NCT00496197|Secondary|Number of Participants With Microbiological Response at EOT|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251734|NCT00496197|Secondary|Number of Participants With Clinical Response at EOT|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251735|NCT00496197|Primary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)|Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Treatment (Day 5 up to Day 42)|Modified Intent to Treat population (MITT): includes all participants who received at least 1 dose of study medication and with a positive baseline culture for a Candida spp. N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
1251737|NCT00496080|Secondary|Decrease in Fibroid Bulk|"Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo.~Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200."|From baseline to 12-months|ITT (Due to early termination, only 39 subjects had MRIs. No data for 8 participants.)|||participants|||Number
1251738|NCT00496080|Secondary|Procedural Satisfaction|"Number of participants with responses of either satisfied or very satisfied on a qualitative survey that ranged from very dissatisfied (worst) to very satisfied (best)"|12 months|ITT (No data for 19 participants)|||participants|||Number
1251739|NCT00496080|Secondary|Maintenance of Menses|Number of participants with continuation of menstrual cycles without interruption for three consecutive months|12 months|ITT (No data for 30 participants)|||participants|||Number
1251740|NCT00496080|Secondary|Mean Improvement in Health Related Quality of Life (HRQOL) Scores|"Participants categorized as better in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. Better was defined as a change of +12 or more from baseline at 12 mo."|From baseline to 12 months|ITT (No data for 20 participants)|||participants|||Number
1251741|NCT00496080|Primary|Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score|Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.|From baseline to 12 months|ITT (No data for 18 participants)|||participants|||Number
1251742|NCT00496080|Primary|No Surgical Re-intervention|Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.|Study completion|ITT (Data missing for 5 participants)|||participants|||Number
1251743|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
1251744|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
1251745|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
1251746|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
1251747|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
1251748|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
1251749|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
1251750|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
1251751|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
1251752|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
1251753|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
1251754|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
1253765|NCT00479258|Primary|To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period|No subjects were dosed therefore no data collected.|12 months|No subjects were dosed therefore no participants for analysis.||||||
1251755|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
1251756|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
1251757|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
1251758|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
1251759|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
1251760|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
1251761|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
1251762|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
1251763|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
1251764|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
1251765|NCT00496054|Primary|The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results.|||Percentage of Participants|||Number
1251766|NCT00496054|Primary|The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
1251767|NCT00495820|Secondary|Clinical Global Impression|The Clinical Global Impression scale is an observational scale of global evaluation, which assesses the change in degree of illness in relation to the original assessment. The severity sub-scale reported below ranges from 1-7 wherein higher scores indicate worsening severity of illness.|At 12 weeks||||units on a scale||Standard Deviation|Mean
1251768|NCT00495820|Secondary|Mini-mental State Examination (MMSE) at 12 Weeks|Mini-mental State Examination (MMSE) is a commonly used screening measure for cognition with questions pertaining to orientation, registration, recall, visuo-spatial construction, attention span etc. Score on MMSE ranges from 0-30, higher scores indicating improving cognition|At 12 weeks||||units on a scale||Standard Deviation|Mean
1251769|NCT00495820|Primary|Apathy Evaluation Scale Score at 12 Weeks|The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy.|At 12 weeks||||units on a scale||Standard Deviation|Mean
1251770|NCT00495794|Secondary|LDL Control||12 months after invention period|Includes only participants with a LDL in the 12 months after the intervention period.|||mg/dl||Standard Deviation|Mean
1251771|NCT00495794|Secondary|A1c Control||12 months after intervention period|Includes only participants with an A1c in the 12 months after the intervention period.|||percentage of total hemoglobin||Standard Deviation|Mean
1251772|NCT00495794|Primary|Change in Systolic Blood Pressure||6 months prior to 6 months after the intervention period|intention to treat analysis|||mmHg||95% Confidence Interval|Mean
1253804|NCT00478647|Secondary|Percent Change From Baseline to Week 53 in Platelet Count||Week 53|ITT population.|||percent (%) change||90% Confidence Interval|Mean
1251774|NCT00495755|Secondary|The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD).|Efficacy measured as complete response (CR), partial response (PR), stable disease (SD) and cGVHD progression (PD). CR is defined as absence of all measurable or symptomatic cGVHD, PR is defined as a remission in some but not all involved organs. SD is defined as no measurable change in GVHD and PD is defined as progression in at least one involved organ.|12 weeks||||participants|||Number
1251775|NCT00495755|Primary|The Maximum Tolerated Dose (MTD) of a Four-week Course of Alemtuxumab in Chronic GVHD for Patients With an Incomplete Response to Steroids|MTD: The dose at which fewer or equal to 2/6 experience a dose-limiting toxicity|12 weeks||||mg|||Number
1251776|NCT00495677|Other Pre-specified|Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping|CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred.|Pre-dose on Day 1|Results for this outcome were not analyzed because there were no unusual patterns of response or an unexplained excess of adverse events that warranted genotyping.||||||
1251777|NCT00495677|Other Pre-specified|Number of Participants With Viral Tropism and Resistance|Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2.|Screening, pre-dose on Day 1; Day 11, 25|Results for this outcome was not reported because data was collected in individual participant listings, but not summarized for analyses.||||||
1251778|NCT00495677|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).|0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1251779|NCT00495677|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.|||hours||Full Range|Median
1251780|NCT00495677|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1251781|NCT00495677|Secondary|Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load|The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.|Day 1 up to Day 25|Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.|||participants|||Number
1251782|NCT00495677|Primary|Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11|Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.|Baseline, Day 11|Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.|||log10 copies/mL||Standard Deviation|Mean
1251783|NCT00495625|Primary|Number of Participants With Progressive Disease (PD) at Interim Analysis|Progressive Disease Rate. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.|||participants|||Number
1251784|NCT00495625|Primary|Number of Participants With Stable Disease (SD) at Interim Analysis|Stable Disease (SD) Rate at Interim Analysis. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.|||participants|||Number
1251785|NCT00495625|Secondary|Number of Participants With Serious Adverse Events (SAEs)|The toxicity of sunitinib malate in the treatment in unresectable HCC|On Treatment to Off Study - average of 7 months per participant|All participants|||participants|||Number
1251786|NCT00495625|Secondary|Number of Participants With Overall Survival (OS)|Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC|On Treatment to Off Study - average of 7 months per participant|Participants who had not expired on their off study date.|||participants|||Number
1251787|NCT00495625|Secondary|Participant Time to Tumor Progression (TTP)|Investigators planned to determine the time to tumor progression (TTP) of sunitinib malate in the treatment in unresectable Hepatocellular Cancers (HCC). TTP is defined as the duration of time from start of treatment to time of progression.|On Treatment to Off Study - average of 7 months per participant|Not analyzed. The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.|||months||Full Range|Mean
1253805|NCT00478647|Secondary|Change From Baseline to Week 53 in Hemoglobin Concentration||Week 53|ITT population.|||g/dL||90% Confidence Interval|Mean
1251788|NCT00495625|Primary|Number of Participants With Partial Response (PR) at Interim Analysis|Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.|||participants|||Number
1251789|NCT00495612|Secondary|Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16|The challenge was stopped if a patient stated that they were extremely uncomfortable and would like to leave the room, the FEV1 has decreased by 50% from the baseline value, or after 60 minutes of exposure. The duration of allergen exposure was the time from when the patient entered the exposure room until the challenge stopped, with a maximum of 60 minutes. A longer duration indicates greater tolerance of the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Minutes||95% Confidence Interval|Median
1251790|NCT00495612|Secondary|Area Under the Curve (AUC) of Change in Nasal-ocular Symptom Score (NOSS) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|The NOSS was defined as the total of 4 sub-scores: Nasal congestion, rhinorrhea, nasal pruritus, ocular pruritus, and ocular tearing. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum NOSS was 15 points. A lower score indicates a reduced response to the allergen exposure and fewer nasal-ocular symptoms.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Units on a scale*hours||Standard Deviation|Mean
1251791|NCT00495612|Secondary|Area Under the Curve (AUC) of Change in Chest Symptom Score During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|The chest symptom score was defined as the total of 4 sub-scores: Chest tightness, wheezing, shortness of breath, and cough. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum chest symptom score was 12 points. A lower score indicates a reduced response to the allergen exposure and fewer respiratory symptoms.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Units on a scale*hours||Standard Deviation|Mean
1251792|NCT00495612|Secondary|Maximum Percent Change in Forced Expiratory Volume in 1 Second (FEV1) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Percent change||Standard Deviation|Mean
1251793|NCT00495612|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1) at 20 Minutes of a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Percent change||Standard Deviation|Mean
1251794|NCT00495612|Primary|Area Under the Curve (AUC) of Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Over a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of the baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Percent change from pre-challenge*hours||Standard Deviation|Mean
1251795|NCT00495586|Secondary|Number of Days Till the Next Exacerbation|For the assessment of the time till next exacerbation patients were monitored over a period of 365 days on a three-monthly basis. Patients were instructed to contact their physician immediately if there was any change in their health status. Diagnosis of a new exacerbation was based on the same clinical criteria described previously. For the calculation of time to the next exacerbation, all clinical failures occurring during therapy were counted as zero exacerbation-free interval days.|One year|Patients with clinical success at the end of therapy visit|||Days||Inter-Quartile Range|Median
1251796|NCT00495586|Primary|Number of Patients Who Were Cured|Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability|Day 9-11|Clinical cure at end of therapy visit at day 9-11 in the ITT population|||Participants|||Number
1251797|NCT00495521|Secondary|Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion||4 weeks|||||||
1251798|NCT00495521|Secondary|Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization||2 weeks and 4 weeks|||||||
1251799|NCT00495521|Secondary|Time to Normalization of All Other Components in the Diary||up to 4 weeks|||||||
1251800|NCT00495521|Secondary|Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance||up to 4 weeks|||||||
1251801|NCT00495521|Secondary|Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary||4 weeks|||||||
1251802|NCT00495521|Secondary|Change in IMPACT-III From Baseline to 4 Weeks||4 weeks|||||||
1251810|NCT00495495|Secondary|Laser Fluorescence Progression-12 Month (Increase at Least 10)|The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations.|||teeth|Participants||Number
1251811|NCT00495495|Secondary|Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30)|The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units or an increase in DIAGNOdent reading from below 20 to above 30 units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations (subjects who completed all four treatment/examination visit at Baseline, 3-, 6-, 9-month as well as Final examination at 12-month.|||teeth|Participants||Number
1251812|NCT00495495|Secondary|Progression of Radiographic Scores at 12 Months|"Clinically significant changes for Bitewing x-rays indicating caries progression would be changes in x-ray criterion for lesion presence from “no” to “yes” or for lesion depth to a D1 or higher. The occlusal surface of study teeth will be evaluated using the following scale:~Lesion presence: yes /no~Lesion depth:~E1 = outer half of enamel E2 = inner half of enamel D1 = outer third of dentin D2 = middle third of dentin D3 = inner third of dentin or greater/pulpal exposure"|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations (subjects who completed all four treatment/examination visit at Baseline, 3-, 6-, 9-month as well as Final examination at 12-month.|||teeth|Participants||Number
1251813|NCT00495495|Secondary|Change in Caries Lesion Activity|"Change in caries lesion activity at One Year. All teeth were considered Active at Baseline~Caries Lesion Activity score:~= Inactive – surface of enamel appears whitish, brownish or black. Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface.~= Active lesion – surface of enamel appears whitish/yellowish opaque with loss of luster. The surface feels rough when the tip of the probe is moved gently across the surface."|Baseline and one year|"Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations.~Clinically significant changes for Activity Scores were indicated by a change in caries activity status from active to inactive. It should be noted that all teeth were considered active at baseline."|||teeth|Participants||Number
1251814|NCT00495495|Primary|ICDAS Severity Value|"Clinically significant changes indicating caries progression are defined as changes in ICDAS severity values from 1 or 2 to a 3 or higher, or from a 3 or 4 to a 5 or higher. The severity criteria are as follows:~0 = Sound tooth surface.~= First visual change in enamel.~= Distinct visual change in enamel.~= Localized enamel breakdown due to caries with no visible dentin.~= Underlying dark shadow from dentin, with or without localized enamel breakdown.~= Distinct cavity with visible dentin.~= Extensive distinct cavity with visible dentin."|Baseline and One Year|The study utilized a split-mouth design. The results posted are for the Per Protocol dataset. Subjects who completed all four treatment/examination visits as well as final examination visit without major protocol violations were included in this dataset.|||teeth|Participants||Number
1251815|NCT00495469|Secondary|Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy|Hematology parameters: Hemoglobin, Hematocrit, Platelet count and White blood cells were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).|Up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1251816|NCT00495469|Secondary|Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy|Chemistry parameters: Albumin, Alkaline phosphatase, Alanine animotransferase, Aspartate aminotransferase, Total billirubin, Calcium, Carbon dioxide/Bicarbonate, Glucose, Potassium, Sodium, Phosphorus and Total protein were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1251817|NCT00495469|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline|Full 12-lead ECGs were recorded at Randomization (Week 0), Week 4, and Week 12 or early withdrawal. If the QTc was >500 milliseconds on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 milliseconds, the participant was withdrawn from the study.|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1251818|NCT00495469|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy|Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured pre-dose in duplicate, after the participant has been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements.|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1251819|NCT00495469|Secondary|Number of Participants With On-therapy Hypoglycemia|Participants were provided with a Daily Glucose Monitoring Log to record glucose meter readings and to record symptoms of hypoglycemia. A separate electronic case report form (eCRF) page was provided to capture events of hypoglycemia.|Up to Week 12|Safety Population.|||Participants|||Count of Participants
1251852|NCT00495131|Secondary|Histologic Response|Histologic response: improvement of at least 2 grade of scores by Ishak liver histologic classification by end of follow up liver biopsy to baseline liver biopsy|18 months|Data included for analysis only for patients with paired liver biopsies.|||Participants|||Number
1259898|NCT00433966|Primary|Stent Arm - Ischemic Target Lesion Revascularization|Number of Participants With Ischemic Target Lesion Revascularization|1 year||||Participants|||Count of Participants
1251820|NCT00495469|Secondary|Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Week 12|Safety Population consisted of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1251821|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Body Weight|Body weight measurement was taken at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF.|||kilograms||Standard Error|Least Squares Mean
1251822|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Error|Least Squares Mean
1251823|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Error|Least Squares Mean
1251824|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c)|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
1251825|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c)|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
1251826|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Total Cholesterol|Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
1251827|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Triglycerides|Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
1251828|NCT00495469|Secondary|Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12|Differences between treatment groups in the proportion of participants who achieved FPG targets of <7.0 millimoles per liter (mmol/L) (126 milligrams per deciliter [mg/dL]) and <7.8 mmol/L (140 mg/dL) at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline FPG. The proportion of participants who achieved the target of <5.5 mmol/L (100 mg/dL) at Week 12 within each treatment group were summarized only. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in FPG (1.7 mmol/L [>=30 mg/dL]) at Week 12 were assessed in the same manner.|Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1251829|NCT00495469|Secondary|Number of Participants Who Were HbA1c Responders at Week 12|Differences between treatment groups in the proportion of participants who achieved HbA1c targets of <=6.5% and <7% at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline HbA1c. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in HbA1c (>=0.7%) at Week 12 were assessed in the same manner.|Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1251853|NCT00495131|Primary|Sustained Biochemical Response|Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization|18 months|Patients with end of follow-up alanine aminotransferase (ALT) levels|||Participants|||Number
1261105|NCT00425269|Secondary|Insulin, 2-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
1251830|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Fructosamine (Corrected)|The blood samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||micromoles per liter (µmol/L)||Standard Error|Least Squares Mean
1251831|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)|The samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1251832|NCT00495469|Secondary|Mean Change From Baseline in HbA1c at Weeks 4 and 8|The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 4 and 8 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF.|Baseline (Week 0) and at Week 4 nad 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Deviation|Mean
1251833|NCT00495469|Primary|Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12|The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean.|Baseline (Week 0) and at Week 12|ITT Population consisted of all randomized participants who received at least one dose of study medication, had a Baseline assessment, and had at least one corresponding on-therapy efficacy assessment. Only those participants with data available at the indicated time points were analyzed.|||Percentage||Standard Error|Least Squares Mean
1251834|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of follow up||||participants|||Number
1251835|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of treatment||||participants|||Number
1251836|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 16||||participants|||Number
1251837|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 8||||participants|||Number
1251838|NCT00495391|Secondary|Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.|After 4 weeks combination treatment||||participants|||Number
1251839|NCT00495391|Secondary|Early Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.|After 12 weeks combination treatment||||participants|||Number
1251840|NCT00495391|Secondary|End of Treatment Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.|At end of treatment||||participants|||Number
1251841|NCT00495391|Primary|Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.|24 weeks after end of treatment||||participants|||Number
1251842|NCT00495222|Primary|Knotting Elements Placed|completion of plication (1-3 knotting elements placed per procedure)|intra-operative|Intent to Treat|||elements|||Number
1251843|NCT00495157|Secondary|Adverse Events||Measured during the 36-week treatment period|||||||
1251844|NCT00495157|Secondary|Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids||Measured during the 36-week treatment period|||||||
1251845|NCT00495157|Secondary|Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25||Measured during the 36-week treatment period|||||||
1251846|NCT00495157|Secondary|Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)||Measured during the 36-week treatment period|||||||
1251847|NCT00495157|Secondary|Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)||Measured during the 36-week treatment period|||||||
1251848|NCT00495157|Secondary|Number of Asthma Exacerbations||Measured during the 36-week treatment period|||||||
1251849|NCT00495157|Secondary|Time to First Asthma Exacerbation||Measured during the 36-week treatment period|||||||
1251850|NCT00495157|Secondary|Number of Episodes of Treatment Failure||Measured during the 36-week treatment period|||||||
1251856|NCT00495079|Primary|Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation|Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC>=1X10^9/L or Platelet count>=100x10^9/L, absence of blasts in blood and morrow (<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count <100x10^9/L or ANC<1x10^9/L.|Response assessment at the end of each 28 days course|The IRRC evaluable population included all subjects who received at least 1 dose of study drug and who has reviewable data to assess and determine response or lack of response as determined by the IRRC.|||participants|||Number
1251857|NCT00495079|Secondary|Overall Survival|Time, in days, from informed consent date until the date of death or date of last contact|unlimited|Based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant (HSCT)(n=10)|||days||95% Confidence Interval|Median
1251858|NCT00495079|Secondary|Duration of CR + CRi|Duration of response for those subjects who achieved CR or CRi|CR + CRi duration was calculated from the date the subject first met the definition of CR or CRi until the date of relapse|Based on the first date of CR or CRi to the date of the last available histologic assessment of the same response (n=8)|||days||95% Confidence Interval|Median
1251859|NCT00495079|Primary|Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi)|CR is defined as no evidence of ALL: ANC>or=1x10^9/L or platelet count>100x10^9/L, absence of leukemia blast cells in blood and marrow (<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count< 100x10^9/L or ANC< 1x10^9/L. Partial remission(PR):CR with>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.|Response assessment performed at the end of each 28 day course.|Subjects who had CR plus CRi by the PI and the IRRC assessments using the International Working Group Criteria. The Intent-to-Treat Analysis, n=65, minimum 1 dose. The IRRC, n=53, 1 dose, assess response as determined by the IRRC. Analyses, a Simon’s 2-stage minimax design where the type I error alpha was set at 0.10 and the power was 80%.|||participants|||Number
1251860|NCT00494975|Secondary|Detailed Questionnaire at Baseline and After 18 Sessions||at baseline and after 18 sessions|||||||
1251861|NCT00494975|Primary|Visual Analogue Scale (VAS) Score for Pruritus|"a VAS is a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their pruritus.~0 (no pruritus) - 10 (most severe pruritus) The investigator will determine the pruritic intensity at baseline, every 3 sessions by VAS score, and by detailed questionnaire at baseline and after 18 sessions"|VAS score at baseline and after 6 -week phototherapy||||Units on a scale||Standard Deviation|Mean
1251862|NCT00494871|Secondary|Event Rate Adjudicated Non-major Clinically Relevant Bleeding|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-major clinically relevant bleeding was clinically overt bleeding that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).|||Events per 100 patient-years|||Number
1251863|NCT00494871|Secondary|Event Rate of Adjudicated Major Bleeding|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 g/dL or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).|||Events per 100 patient-years|||Number
1251864|NCT00494871|Secondary|Event Rate of All-cause Death|All events were adjudicated and confirmed by a central independent committee blinded to treatment. All-cause death included vascular death and non-vascular death.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251865|NCT00494871|Secondary|Event Rate of Stroke With Serious Residual Disability|All events were adjudicated and confirmed by a central independent committee blinded to treatment. A stroke was considered disabling if the participant’s modified Rankin score was between 3 and 5, inclusive.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251866|NCT00494871|Secondary|Event Rate of Vascular Death|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia)|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251867|NCT00494871|Secondary|Event Rate of Myocardial Infarction|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Myocardial infarction was assessed based on either cardiac bio-markers (troponin I, troponin T, or creatine kinase-muscle and brain subunit isozyme), new abnormal Q waves appeared on ECG for 2 or more leads, or autopsy confirmation.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251879|NCT00494780|Secondary|Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]).|Week 15 (Visit 22)|FAS. Data were provided for the number of participants who had a value. Participants withdrawn during the study were not analyzed.|||milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
1251868|NCT00494871|Secondary|Event Rate of Non-CNS Systemic Embolism|"All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-CNS systemic embolism was abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (such as trauma, atherosclerosis, and instrumentation). Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded from this category."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251869|NCT00494871|Secondary|Event Rate of Stroke|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded.), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available.).|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251870|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death|"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Myocardial infarction: assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for ≥2 leads, or autopsy confirmation. Any death that was not clearly non-vascular."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251871|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death|"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Any death that was not clearly non-vascular."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251872|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism|"This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
1251873|NCT00494871|Primary|Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding|Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).|||Events per 100 patient-years|||Number
1251874|NCT00494806|Primary|Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator.|Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).|Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).|Intention to treat (ITT) method was used.|||Days||Standard Deviation|Mean
1251875|NCT00494780|Secondary|Vss at the Sixth Infusion (Week 15, Visit 22)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1251876|NCT00494780|Secondary|CL After the Sixth Infusion (Week 15, Visit 22)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1251877|NCT00494780|Secondary|Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)|Half life is defined as the period of time required for the amount of drug in the body to be reduced by half.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
1251878|NCT00494780|Secondary|AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milligrams * hours/liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
1255987|NCT00462644|Primary|Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test||pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test|||||||
1251880|NCT00494780|Secondary|Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy|This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented.|Maximum of 6 years follow-up|FAS||||||
1251881|NCT00494780|Primary|Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)|Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions).|Maximum of 23 months after the start of treatment|FAS|||participants|||Number
1251882|NCT00494780|Secondary|Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22|The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100.|Visit 1 (Screening, Week -2) and Visit 22 (Week 15)|FAS. Only those participants who remained in the study at Visit 22 were analyzed.|||Percent change in serum complement CH50||Full Range|Median
1251883|NCT00494780|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA.|Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)|FAS. Participants dropped out of the study as the study progressed.|||participants|||Number
1251884|NCT00494780|Secondary|Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section.|Up to 22 months after study start|FAS|||participants|||Number
1251885|NCT00494780|Secondary|Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)|The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment.|Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)|FAS. Only those participants who provided samples at Visit 33 were analyzed.|||Percent change in cell counts||Full Range|Median
1251886|NCT00494780|Secondary|Duration of Response|The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death.|Followed up to 5 years|FAS. Only those participants with a response were analyzed.|||months||95% Confidence Interval|Median
1251887|NCT00494780|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression or death.|Followed up to 5 years|FAS|||months||95% Confidence Interval|Median
1251888|NCT00494780|Secondary|Time to New Anti-follicular Lymphoma (FL) Therapy|Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed.|Followed up to 5 years|FAS|||months||95% Confidence Interval|Median
1251889|NCT00494780|Secondary|Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)|The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100.|Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)|FAS. Participants were withdrawn from the study between Visits 1 and 33.|||Percent change in tumor size||Full Range|Median
1251890|NCT00494780|Secondary|Number of Participants With Complete Remission (CR) at Visit 26|Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease.|Maximum of 23 months after the start of treatment|FAS|||participants|||Number
1251891|NCT00494676|Secondary|Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility improvement scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and then discontinued wearing prism glasses.|||logits||Standard Deviation|Mean
1251901|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Lean Body Mass|Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).|Baseline and 9 weeks|Participants who had lean body mass data available at baseline and week 9.|||kg||Standard Deviation|Mean
1251916|NCT00494494|Primary|Post-operative Best Corrected Visual Acuity (BCVA)|The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.|baseline and 8 weeks||||letters||95% Confidence Interval|Mean
1251892|NCT00494676|Secondary|Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and continued to wear prism glasses in the long term.|||logits||Standard Deviation|Mean
1251893|NCT00494676|Secondary|Mobility Change Score (All Participants Who Completed Crossover)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|Only participants who completed the crossover were included in this analysis|||logits||Standard Deviation|Mean
1251894|NCT00494676|Primary|"Overall Proportion Saying Yes to Real Prism Glasses"|"At the end of each crossover period, participants were asked a yes/no question: If the study were to end today, would you want to continue with these prism glasses (i.e. the prism glasses worn in that period)? The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants saying yes to real prism glasses and the proportion saying yes to sham prism glasses."|Evaluated after 4 weeks of wearing each type of prism glasses|Only participants who completed the crossover were included in this analysis|||participants|||Number
1251895|NCT00494585|Primary|Number of Participants With Objective Response|Objective response = Complete Response, absence sign/symptoms of disease (without use of growth factors, hydroxyurea, anagrelide, or transfusions for > 1 month); Partial Response, absence of progressive disease (PD), and improvement in 2+ parameters (if abnormal): Absolute neutrophil count (ANC), hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts; Clinical Improvement, absence of PD, and improvement in 1 parameter: ANC, hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts). [International Working Group on Myelofibrosis Research and Treatment]|Response assessed after each 3 cycles (cycle = 30 days)|Intention to treat.|||Participants|||Number
1251896|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The mental health component summary score is calculated from the four scales of VT, SF, MH, and RE. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||T-score||Standard Deviation|Mean
1251897|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The mental health component summary score is calculated from the four scales of VT, SF, MH, and RE. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||T-score||Standard Deviation|Mean
1251898|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The physical component summary score is calculated from the four scales of PF, RP, BP, and GH. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||T-score||Standard Deviation|Mean
1251899|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The physical component summary score is calculated from the four scales of PF, RP,BP, and GH. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||T-score||Standard Deviation|Mean
1251900|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Lean Body Mass|Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).|Baseline and 9 weeks|Participants who had lean body mass data available at baseline and week 9.|||kg||Standard Deviation|Mean
1251914|NCT00494507|Primary|HOP Attack Rate|The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HOP participants.|8 weeks||||attacks per week||Inter-Quartile Range|Median
1251902|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the percent of predicted normal given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average percent of predicted normal score. A higher number indicates a better outcome.~The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||average percent of predicted normal||Standard Deviation|Mean
1251903|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the percent of predicted normal given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average percent of predicted normal score. A higher number indicates a better outcome.~The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||average percent of predicted normal||Standard Deviation|Mean
1251904|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the number of standard deviations from normal (Z-score) given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average standardized MVICT score. A positive Z-score indicates a better outcome.~The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||Z-score||Standard Deviation|Mean
1251905|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the number of standard deviations from normal (Z-score) given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average standardized MVICT score. A positive Z-score indicates a better outcome.~The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||Z-score||Standard Deviation|Mean
1251906|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score|"The strength of each of 26 individual muscles was graded using a modified 13-point Medical Research Council scale ranging from 0-5. Recorded grades were converted to numerical values as follows prior to averaging across muscles to form a composite score: 0 = 0; 1 = 1; 2- = 1.67; 2 = 2; 2+ = 2.33; 3- = 2.67; 3 = 3; 3+ = 3.33; 4- = 3.67; 4 = 4; 4+ = 4.33; 5- = 4.67; 5 = 5. A higher score represents a better outcome, i.e. 5 = normal strength.~The following muscles were tested: shoulder abductor (left/right), elbow extensor (left/right), elbow flexor (left/right), wrist extensor (left/right), wrist flexor (left/right), hip flexor (left/right), hip extensor (left/right), hip abductor (left/right), knee extensor (left/right), knee flexor (left/right), ankle dorsiflexor (left/right), ankle plantar flexor (left/right), neck extensor, neck flexor."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||units on a scale||Standard Deviation|Mean
1251907|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score|"The strength of each of 26 individual muscles was graded using a modified 13-point Medical Research Council scale ranging from 0-5. Recorded grades were converted to numerical values as follows prior to averaging across muscles to form a composite score: 0 = 0; 1 = 1; 2- = 1.67; 2 = 2; 2+ = 2.33; 3- = 2.67; 3 = 3; 3+ = 3.33; 4- = 3.67; 4 = 4; 4+ = 4.33; 5- = 4.67; 5 = 5. A higher score represents a better outcome, i.e. 5 = normal strength.~The following muscles were tested: shoulder abductor (left/right), elbow extensor (left/right), elbow flexor (left/right), wrist extensor (left/right), wrist flexor (left/right), hip flexor (left/right), hip extensor (left/right), hip abductor (left/right), knee extensor (left/right), knee flexor (left/right), ankle dorsiflexor (left/right), ankle plantar flexor (left/right), neck extensor, neck flexor."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||units on a scale||Standard Deviation|Mean
1251908|NCT00494507|Secondary|HOP Endpoint of Acute Worsening|Increase in attack frequency or severity in HOP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.|0-9 weeks||||participants|||Number
1251909|NCT00494507|Secondary|HYP Endpoint of Acute Worsening|Increase in attack frequency or severity in HYP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.|0-9 weeks||||participants|||Number
1251910|NCT00494507|Secondary|HOP Attack Duration|HOP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.|8 weeks||||hours per week||Inter-Quartile Range|Median
1251911|NCT00494507|Secondary|HYP Attack Duration|HYP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.|8 weeks||||hours per week||Inter-Quartile Range|Median
1251912|NCT00494507|Secondary|HOP Severity-weighted Attack Rate|HOP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.|8 weeks||||severity-weighted attacks per week||Inter-Quartile Range|Median
1251913|NCT00494507|Secondary|HYP Severity-weighted Attack Rate|HYP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.|8 weeks||||severity-weighted attacks per week||Inter-Quartile Range|Median
1261106|NCT00425269|Secondary|Insulin, 0-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
1251919|NCT00494494|Primary|Pre-operative Best Corrected Visual Acuity (BCVA)|Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.|baseline|The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA).|||letters||Standard Deviation|Mean
1251920|NCT00494494|Primary|Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)|The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)|baseline and 8 weeks|Three subjects in the treatment group and two subjects in the control group had unreliable preoperative OCT scans because of dense posterior subcapsular cataracts. These subjects were excluded from the analysis.|||microns||95% Confidence Interval|Mean
1251921|NCT00494481|Primary|Number of Patients With a Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off||||Participants|||Number
1251922|NCT00494442|Secondary|Progression-Free Survival (PFS)|Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.|End of study|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm|||Days||95% Confidence Interval|Median
1251923|NCT00494442|Secondary|Best Percentage Change in Tumour Size|The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).|End of study|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm|||Percent change||Full Range|Median
1251924|NCT00494442|Secondary|Duration of Response|Duration of response to olaparib|End of study|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm|||Days||Full Range|Median
1251925|NCT00494442|Secondary|Clinical Benefit (CB)|Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)|End of study|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm)|||Percentage of participants||95% Confidence Interval|Number
1251926|NCT00494442|Primary|Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm)|||Participants|||Number
1251927|NCT00494299|Post-Hoc|Number of Death Cases Due to Any Cause||From randomization of the first subject until death due to any cause assessed up to 55 months.|"Intention to treat (ITT) population. Overall Survival is shown in Secondary Outcome Measure: Overall Survival."|||Participants|||Number
1251928|NCT00494299|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.|From randomization of the first subject until 39 months later.|"Median overall survival (OS) and 95% Confidence interval (CI) were not estimable in Placebo Group and Upper Limit of 95% CI was not in Sorafenib Group because of more than half (188 for Placebo,186 for Sorafenib) of the individual study populations censored. Number of death is shown in Post-Hoc Outcome Measure."||||||
1251929|NCT00494299|Primary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.|Intention to treat (ITT) population.|||days||95% Confidence Interval|Median
1251930|NCT00494234|Secondary|Change From Baseline in ECOG Performance Status: Improvement Rate|The change in ECOG performance status was defined as improved (meaning the ECOG score is less than the baseline value), no change (ECOG is same as at baseline), worsened (ECOG score is greater than the baseline value) or missing (the ECOG score is missing or was not recorded at baseline). If no measurement was recorded at Cycle 1 Day 1, the change was calculated in relation to the last recorded ECOG value prior to Day 1.|At cycle 7 day 1 (ie, after completing 6 cycles of treatment)||||Participants with an improvement in ECOG|||Number
1251931|NCT00494234|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression. Those patients who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where patients had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment.|End of study||||Days||95% Confidence Interval|Median
1251932|NCT00494234|Secondary|Best Percent Change in Tumour Size|The tumour size is defined as the sum of the longest diameters as measured among all target lesions.|End of study||||Percent change in tumour size||95% Confidence Interval|Mean
1251933|NCT00494234|Secondary|The Clinical Benefit Rate (CBR)|The Clinical Benefit Rate (CBR) is defined as the percentage of patients with a RECIST tumour response of confirmed CR, PR or stable disease (SD) for ≥8 weeks +/- 1 week visit window.|End of study|Per protocol|||Percentage of Participants||95% Confidence Interval|Number
1251934|NCT00494234|Secondary|Duration of Response to Olaparib||Time from response (CR or PR) to progression per RECIST criteria|Per protocol|||Days||Full Range|Median
1251935|NCT00494234|Primary|Confirmed Objective Tumour Response (According to RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. Up to 2 years.||||Participants|||Number
1251936|NCT00494221|Secondary|Overall Survival|Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored.|Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)||||Months||Full Range|Median
1251937|NCT00494221|Secondary|Duration of Response|Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups).|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)||||Months||Standard Deviation|Mean
1251938|NCT00494221|Secondary|Best Percentage Change in Tumour Size|Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions|Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)||||Percentage||Standard Deviation|Mean
1251939|NCT00494221|Secondary|Objective Tumour Response Rate|Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)||||Participants|||Number
1251940|NCT00494221|Primary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)||||Months||Full Range|Median
1251941|NCT00494143|Secondary|Peak Intact Knee Loading|The biomechanical measure of the first peak of the knee external adduction moment|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection||||newton meters per kilogram||Standard Deviation|Mean
1251942|NCT00494143|Secondary|Prosthetic Foot Push Off Peak Power|The biomechanical measurement of the power generated by the prosthetic foot during the push off component of stance phase. The peak power output during the push off component of stance phase was calculated in Joules. It was subsequently standardized for body weight in Kgs. The final units were therefore Joules/Kg.|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection||||joules per kilogram||Standard Deviation|Mean
1251943|NCT00494143|Primary|Metabolic Oxygen Consumption During Ambulation|VO2 was collected at rest and while walking at a controlled walking speed of 1.14 meters/second for 10 minutes until they reached a steady state for 3 minutes. This was repeated for each foot condition. VO2 at the steady state was recorded in ml/min and were subsequently converted to calories and and then to Watts. The data were then corrected for body weight by dividing by weight in Kg. The gross VO2 in Watts/Kg during walking were then adjusted to net VO2 in Watts/kg by subtracting the resting metabolic rate.|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection||||Watts per kilogram||Standard Deviation|Mean
1251944|NCT00494091|Other Pre-specified|Volume of Distribution at Steady State (Vss) of Temsirolimus|"Vss is an estimate of the volume of distribution at steady state. It is used to predict the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||Liter||Standard Deviation|Mean
1251945|NCT00494091|Other Pre-specified|Clearance (CLss) of Temsirolimus|"Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of temsirolimus (R0/Css). As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||Liter per hour (L/h)||Standard Deviation|Mean
1251946|NCT00494091|Other Pre-specified|Area Under the Concentration-Time Curve (AUC)|"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng*h/mL||Standard Deviation|Mean
1251961|NCT00494013|Secondary|Number of Injections of Basal Insulin Analog at Endpoint||24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||participants|||Number
1261009|NCT00425945|Secondary|LDL|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||mg/dL||Standard Deviation|Mean
1251947|NCT00494091|Other Pre-specified|Plasma Decay Half-Life (t1/2)|"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
1251948|NCT00494091|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)|"Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Full Range|Median
1251949|NCT00494091|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)|"Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1251950|NCT00494091|Secondary|Overall Survival (OS)|Time in months from the date of enrollment to date of death due to any cause. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline Until Death (Up to 4 years)|ITT population included all participants who were enrolled in this study.|||months||95% Confidence Interval|Median
1251951|NCT00494091|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of enrollment to the date of the first documentation of PD, the date of treatment discontinuation except completion of treatment, or date of death due to cancer.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.|||months||95% Confidence Interval|Median
1251952|NCT00494091|Secondary|Duration of Response|Time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest sum longest diameters (LD) recorded since enrollment.|Baseline Up to 4 years|Intent-to-treat ITT population included all participants who were enrolled in this study. Here N (number of participants analyzed) signifies participants with objective disease response.|||months||95% Confidence Interval|Median
1251953|NCT00494091|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria In Solid Tumors (RECIST). CR is disappearance of all target lesions. PR shows at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.|||percentage of participants||95% Confidence Interval|Number
1251954|NCT00494091|Secondary|Progression-free Survival (PFS)|Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.|||months||95% Confidence Interval|Median
1251955|NCT00494091|Primary|Percentage of Participants With Clinical Benefit|Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Baseline Up to 4 years|Intent-to-treat (ITT) population included all participants who were enrolled in this study.|||percentage of participants||95% Confidence Interval|Number
1251956|NCT00494026|Secondary|Pharmacology Toxicity|Radiation Therapy Oncology Group (RTOG) criteria were used for assessing toxicity. Toxicity grade reflected the most severe degree occurring during the evaluated period, not an average. When two criteria were available for similar toxicities, the one resulting in the more severe grade was used. Toxiccity grades range from 0 to 5. Toxicity grade = 5 if that toxicity caused the death of the patient.|every 21-day cycle for 4 cycles|All enrolled patients who received radiotherapy.|||participants|||Number
1251957|NCT00494026|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|Trial was terminated early. Results were not analyzed.|||months||95% Confidence Interval|Median
1251958|NCT00494026|Secondary|Overall Survival|Overall survival is the duration from enrollment to death (includes 1 year follow-up). For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause, 1 year|Trial was terminated early. Results were not analyzed.|||months||95% Confidence Interval|Median
1251959|NCT00494026|Secondary|Progression-free Survival|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|baseline to measured progressive disease|Trial was terminated early. Results were not analyzed.|||months||95% Confidence Interval|Median
1251960|NCT00494026|Primary|Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])|Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured response after chemotherapy and radiation|Trial was stopped too early to assess the primary endpoint.|||proportion of responders|||Number
1261107|NCT00425269|Secondary|C-peptid, 2-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
1251962|NCT00494013|Secondary|Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||Units of Insulin/kilograms (U/kg)||Standard Deviation|Mean
1251963|NCT00494013|Secondary|Total Daily Insulin Dose (Units) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||Units of insulin||Standard Deviation|Mean
1251964|NCT00494013|Secondary|Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||kilograms (kg)||Standard Deviation|Mean
1251965|NCT00494013|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.|||hypoglycemic events per 30 days||Standard Deviation|Mean
1251966|NCT00494013|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.|||hypoglycemic events per 1 year||Standard Deviation|Mean
1251967|NCT00494013|Secondary|Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Results are for the combined titration and maintenance periods.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.|||participants|||Number
1251968|NCT00494013|Secondary|7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint|Actual daily mean blood glucose levels at endpoint.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1251969|NCT00494013|Secondary|Glycemic Variability|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1251970|NCT00494013|Secondary|Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint|Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||percentage of participants|||Number
1251971|NCT00494013|Secondary|Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks||Baseline, 12 Weeks, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.|||percent hemoglobin||Standard Error|Least Squares Mean
1251972|NCT00494013|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||percent of HbA1c||Standard Error|Least Squares Mean
1251973|NCT00493974|Secondary|Change in Urinary Leukotriene (LTE4) Levels|Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours|Baseline and 72 hours later|"Intent to Treat.~Participants with urine sample at both visits."|||(ng/mg Cr.)||Standard Error|Log Mean
1251974|NCT00493974|Secondary|Change in Urinary Leukotriene (LTE4) Levels|Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 24 Hours|Baseline and 24 hours|"Intent to Treat.~Participants with urine sample at both visits."|||(ng/mg Cr.)||Standard Error|Log Mean
1251975|NCT00493974|Secondary|Health-related Quality of Life|"St. George's Respiratory Questionnaire - Total Score~The SGRQ was asked with respect to the last one month as validated for acute exacerbations of COPD by Doll et al.~Scale from 0 (no disability) to 100 (maximum disability).~The SGRQ total score summarizes the impact of airway specific disease on overall health status. Scores range from zero (no impairment) to 100 (maximum impairment). Scores were calculated using the SGRQ scoring Algorithm."|Change from Baseline and 1 Month|Participants were analyzed using the intent to treat method and included those that had SGRQ data at baseline and 1 month.|||Units on a scale||Standard Deviation|Mean
1252031|NCT00493285|Primary|Number of Participants With AEs After Dose 3|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.|||participants|||Number
1251976|NCT00493974|Secondary|Treatment Failure|Treatment failure is defined as death, intubation, readmission to a hospital for COPD, urgent visit to an outpatient or ED provider for symptoms of COPD or intensification of therapy [including second course of antibiotics for COPD, and second course of systemic steroids for COPD]) in the first 30 days after randomization.|Baseline to day 30 visit|Participants were analyzed following intention to treat (ITT) method.|||Participants|||Number
1251977|NCT00493974|Secondary|Change in FEV1/FEV6 Levels|Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline.|from baseline to day of discharge|Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline and missing discharge data.|||ratio||Standard Error|Mean
1251978|NCT00493974|Secondary|Change in FEV1% Predicted|Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline.|Measured at Baseline and Day 30|Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline.|||percent predicted||Standard Error|Mean
1251979|NCT00493974|Primary|Length of Hospital Stay|Admission will begin at the time the subject has been admitted to an inpatient service. Length of Stay (LOS) will be recorded in days. The LOS will be based on the number of days spent in an acute medical ward or in the ICU. Subjects that are admitted and discharged in the same 24 hour period will be recorded as a LOS of 1 day, as will subjects discharged in the ensuing 24 hour period. LOS's greater than 10 days will be truncated to 10 days.|Measured at Day 30|"Participants were analyzed following intention to treat (ITT) method.~One participant randomized to Zileuton withdrew consent before hospital discharge.~Days to discharge are set at a maximum of 10 days."|||Days||Standard Deviation|Median
1251980|NCT00493805|Secondary|Sustained Virological Response (PCR 24 Weeks After End of Treatment)|Sustained virological response (SVR) was defined as undetectable HCV RNA in serum at the end of follow-up (24 weeks after end of therapy) according to a polymerase chain reaction (PCR) assay.|Up to 24 weeks following 48 or 72 weeks of therapy|Information on PCR was available for 7 participants in the non interventional study arm and 11 participants in the interventional study arm.|||Participants|||Number
1251981|NCT00493805|Primary|Early Virological Response in Participants With and Without Insulin Resistance|Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance.|At Week 12 (after start of therapy)|"Interventional arm: At baseline, PCR measurements for 38 out of 42 participants were available.~Non Interventional arm: At baseline, PCR measurements for 15 out of 17 participants were available."|||Participants|||Number
1251982|NCT00493779|Secondary|Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Throughout 4-week follow-up period|All enrolled patients in whom clopidogrel treatment was discontinued.|||Participants|||Number
1251983|NCT00493779|Secondary|Adjusted Mean Percent Changes From Baseline in Hs-CRP|ANCOVA models performed on log scale controlling for site & natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.|Week 1, Week 2, Week 3, Week 4|Number of patients in the biomarker analysis population having baseline hs-CRP value and at least one post clopidogrel withdrawal measurement for hs-CRP value. No imputation technique for missing values was applied.|||percent change||Standard Error|Mean
1251984|NCT00493779|Primary|Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)|Based on ANCOVA models performed on log scale controlling for site & natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.|Week 1, Week 2, Week 3, Week 4 (primary timepoint)|Number of participants in the biomarker analysis population having a baseline soluble CD40 Ligand value (n=95) and at least one post-clopidogrel withdrawal measurement for soluble CD40 Ligand value. No imputation technique for missing values was applied.|||percent change||Standard Error|Mean
1251985|NCT00493779|Secondary|Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin|Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.|Week 1, Week 2, Week 3, Week 4|Number of patients in the biomarker analysis population having baseline Plasma Soluble P-selectin value (n=95) and at least one post-clopidogrel withdrawal measurement for Plasma Soluble P-selectin value. No imputation technique for missing values was applied.|||percent change||Standard Error|Mean
1251986|NCT00493649|Secondary|OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population. Patients were excluded if their cMYC amplification were unknown.|||probability of overall survival||95% Confidence Interval|Number
1251987|NCT00493649|Secondary|DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.|DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.|2 years|ITT population. Patients were excluded if their cMYC amplification were unknown.|||probability of disease-free survival||95% Confidence Interval|Number
1253878|NCT00477750|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up.|registration to death (up to 3 years)|||||||
1251988|NCT00493649|Secondary|Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.|OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population. Patients were excluded if their TOP2A amplification were unknown.|||probability of overall survival||95% Confidence Interval|Number
1251989|NCT00493649|Primary|Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.|DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.|2 years|ITT population. Patients were excluded if their TOP2A amplification were unknown.|||probability of disease-free survival||95% Confidence Interval|Number
1251990|NCT00493636|Secondary|Duration of Overall Response|Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.||||Days||95% Confidence Interval|Median
1251991|NCT00493636|Secondary|Overall Response Rate|Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.||||percentage of participants|||Number
1251992|NCT00493636|Secondary|Time to Progression||Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.||||Days||95% Confidence Interval|Median
1251993|NCT00493636|Secondary|Overall Survival||From the date of randomization to date of death due to any cause, assessed up to 56 months.||||Days||95% Confidence Interval|Median
1251994|NCT00493636|Primary|Progression Free Survival||From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.||||Days||95% Confidence Interval|Median
1251995|NCT00493454|Primary|Objective Response Rate|Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.|Evaluation 4 weeks after administration of Zevalin up to 3 years|One participant did not receive treatment and was excluded from analysis.|||proportion of participants|||Number
1251996|NCT00493311|Secondary|Global Assessment of Treatment at T360 Minutes or Early Termination.|"Subject Global Evaluation was assessed by subject using a 4 point categorical scale in response to the following question:Overall, how would you rate the study treatments? 0 = Poor~= Fair~= Good~= Excellent"|Baseline (T0) to 6 hours||||participants|||Number
1251997|NCT00493311|Secondary|The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration)||360 minutes (6 hours after study drug administration)||||Percentage of participants|||Number
1251998|NCT00493311|Secondary|Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration)||Baseline (T0) to 360 minutes (6 hours) post study drug administration||||Degrees celsius||Standard Deviation|Mean
1251999|NCT00493311|Secondary|Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever.|WSTD3 is defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through the first 3 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.|Baseline (T0) to 3 hours||||Degrees Celsius||Standard Deviation|Mean
1252000|NCT00493311|Primary|Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever|The primary efficacy endpoint was WSTD6 defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through 6 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.|Baseline (T0) to 6 hours post study drug administration||||Degrees Celsius||Standard Deviation|Mean
1252001|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 3|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|||participants|||Number
1255988|NCT00462605|Secondary|Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry||Baseline and 6, 12, 24, and 36 weeks|Due to the limited number of clinical responders, the research assay was not done.||||||
1252002|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 2|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|||participants|||Number
1252003|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 1|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|||participants|||Number
1252004|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 3|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.|||participants|||Number
1252005|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 2|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.|||participants|||Number
1252006|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 1|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.|||participants|||Number
1252007|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
1252008|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
1252009|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
1252010|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Baseline (Day 0 prior to Dose 1)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
1252011|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
1252012|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
1252013|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
1252014|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline|Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Baseline (Day 0 prior to Dose 1)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
1252015|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252016|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252017|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252018|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252019|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252020|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252021|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252022|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252023|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252024|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252025|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252026|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252027|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
1252028|NCT00493285|Primary|Number of Participants With Significant New Medical Conditions (SNMCs)|A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later|Safety population was participants who received investigational product and had any safety follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).|||participants|||Number
1252029|NCT00493285|Primary|Number of Participants With Serious Adverse Events (SAEs)|Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.|Days 0-28 after any dose|The safety population included all subjects who received investigational product for the specified dose and had any safety follow-up.|||participants|||Number
1252030|NCT00493285|Primary|Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)|An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.|Days 0 to 180 days after final dose or the end of the RSV season, whichever was later|The safety population for MA-LRIs included randomized participants who received investigational product and had any safety follow-up.|||participants|||Number
1261010|NCT00425945|Secondary|Total Cholesterol|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||mg/dL||Standard Deviation|Mean
1252032|NCT00493285|Primary|Number of Participants With AEs After Dose 2|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.|||participants|||Number
1252033|NCT00493285|Primary|Number of Participants With Adverse Events (AEs) After Dose 1|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.|||participants|||Number
1252034|NCT00493285|Primary|Number of Participants With SEs After Dose 3|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose|||participants|||Number
1252035|NCT00493285|Primary|Number of Participants With SEs After Dose 2|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.|||participants|||Number
1252036|NCT00493285|Primary|Number of Participants With Solicited Adverse Events (SEs) After Dose 1|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose|||participants|||Number
1252037|NCT00493246|Secondary|Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)|A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV acetaminophen that; Results in Death, Is life-threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is an important medical event|First dose to 30 days following last dose of study medication|All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of IV acetaminophen.|||Participants|||Number
1252038|NCT00493246|Secondary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)|A TEAE is defined as an adverse event that starts on or after the start of study medication|First dose of study medication to 30 days after the last dose of study medication||||Participants|||Number
1252039|NCT00493246|Primary|Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen|t1/2: Terminal elimination half-life|48hrs|"Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the last dose of IV acetaminophen.~Due to only one subject in the Neonate 15mg/kg group, t1/2 (h) was not calculated."|||Hours||Full Range|Median
1252040|NCT00493246|Primary|Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen|AUC 0-t (µg*h/ml): Area under the plasma concentration versus time curve from time 0 (predose) to the time of the dosing interval at steady-state.|Time Zero (just prior to first dose) to 48 hours post first dose||||µg*h/ml||Full Range|Median
1252041|NCT00493246|Primary|Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen|Tmax: Time to reach maximum plasma concentration (Cmax)|Time Zero (just prior to first dose) to 24 hours post first dose|Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.|||Hour||Full Range|Median
1252042|NCT00493246|Primary|Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen|Cmax: Maximum Plasma Concentration|Time Zero (just prior to first dose) to 24 hours post first dose|Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.|||micrograms per milliliter (µg/mL)||Full Range|Median
1252043|NCT00493220|Primary|AUC0-inf|Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)|from the start of ceftriaxone administration to infinity|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)|||µg*hr/mL||Standard Deviation|Mean
1252044|NCT00493220|Primary|AUC0-t|Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)|Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)|||μg*hr/mL||Standard Deviation|Mean
1252045|NCT00493220|Secondary|Tmax|Time to maximum measured plasma ceftriaxone concentration|from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)|||hr||Full Range|Median
1252046|NCT00493220|Secondary|Cmax|Maximum measured plasma ceftriaxone concentration|at the time of the highest measured plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)|||µg/mL||Standard Deviation|Mean
1252047|NCT00493181|Primary|Number of Participants With Complete Response|Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (>/= 3 months) platelet count >/= 60 x 10^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.|Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)||||Participants|||Number
1252048|NCT00493064|Secondary|A Decrease in the Thickness of the Retina|data not available|one year|Although data for this outcome measure was collected, however, data are not available. The PI is retired and no longer works in the organization. Sincere efforts were made to obtain the data, however, no data are available for this outcome.||||||
1252049|NCT00493064|Primary|Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.|improvement with combination of niacin and topical prednisolone acetate|one year||||Participants|||Count of Participants
1252050|NCT00493038|Secondary|Number of Participants With Response (Microbiologically Valid Patients)|Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.|End of Follow-up, Day 24-30 after treatment|Patients valid per protocol with a causative organism cultured.|||Participants|||Number
1252051|NCT00493038|Secondary|Number of Participants With Response (Microbiologically Valid Patients)|Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.|At 'Test-of-Cure', Day 1-3 after treatment|Patients valid per protocol with a causative organism cultured.|||Participants|||Number
1252052|NCT00493038|Secondary|Number of Participants With Response (Per-protocol Population)|Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as “continued clinical cure”|End of Follow-up, Day 24-30 after treatment|PP population at end FU: (1) Clinical evaluation was performed at the TOC visit (2) No other systemic antibacterial agent was administered with study drug up to the TOC visit (3) Adequate treatment compliance (≥80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy (6) FU assessment available|||participants|||Number
1252053|NCT00493038|Secondary|Number of Participants With Response (Intent-to-treat Population)|Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as “clinical cure”|At 'Test-of-Cure', Day 1-3 after treatment|ITT population: participants having at least one observation under study medication|||participants|||Number
1252054|NCT00493038|Primary|Number of Participants With Response (Per-protocol Population)|Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as “clinical cure”|At 'Test-of-Cure', Day 1-3 after treatment|Per Protocol population: subjects to meet all of the following (1) Clinical evaluation was performed at TOC visit (2) No other systemic antibacterial agent was administered with study drug up to TOC visit (3) Adequate treatment compliance (≥ 80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy|||participants|||Number
1252055|NCT00493025|Secondary|Correlation Between EGFR Pathway Component Expression and Activation With Pathologic Complete Response and Survival||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
1252056|NCT00493025|Secondary|Survival||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
1252057|NCT00493025|Secondary|Time to Progression||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
1252058|NCT00493025|Secondary|Safety and Tolerability of This Regimen||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
1252059|NCT00493025|Secondary|Toxicity as Assessed by NCI CTC v2.0||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
1252060|NCT00493025|Primary|Pathologic Complete Response Rate to the Neoadjuvant Regimen|Study closed due to early stopping rule. Patient data was not analyzed. No additional information is available to report|5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
1252061|NCT00493012|Secondary|Change in Hb A1c From Baseline to 12 Months||change from baseline to 12 months||||% glycosylated hemoglobin||Standard Deviation|Mean
1252062|NCT00493012|Secondary|Change in Proinsulin From Baseline to 12 Months||baseline, 12 months||||pmol/l||Standard Deviation|Mean
1252063|NCT00493012|Secondary|Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months||baseline, 12 months||||pg/ml||Standard Deviation|Mean
1252064|NCT00493012|Secondary|Change in C-reactive Protein From Baseline to 12 Months||baseline, 12 months||||mg/l||Standard Deviation|Mean
1252065|NCT00493012|Secondary|Change in LDL-cholsterol From Baseline to 12 Months||baseline, 12 months||||mmol/l||Standard Deviation|Mean
1252066|NCT00493012|Secondary|Change in Triglycerides From Baseline to 12 Months||baseline, 12 months||||mmol/l||Standard Deviation|Mean
1252067|NCT00493012|Secondary|Change in Parathyroid Hormone From Baseline to 12 Months||baseline, 12 months||||pmol/l||Standard Deviation|Mean
1252068|NCT00493012|Secondary|Change in Calcitriol From Baseline to 12 Months||baseline, 12 months||||pmol/l||Standard Deviation|Mean
1252069|NCT00493012|Secondary|Change in 25-hydroxyvitamin D From Baseline to 12 Months||baseline, 12 months||||nmol/l||Standard Deviation|Mean
1252070|NCT00493012|Secondary|Change in Fat Mass From Baseline to 12 Months||baseline, 12 months||||kg||Standard Deviation|Mean
1252071|NCT00493012|Primary|Change in Body Weight From Baseline to 12 Months||baseline, 12 months||||kg||Standard Deviation|Mean
1252072|NCT00492973|Primary|Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.||any point during the first postoperative year||||Number of participants with complication|||Number
1252073|NCT00492973|Primary|Patient Satisfaction||6 weeks, 3 months, and 1 year postoperative|||||||
1252074|NCT00492973|Primary|Amount of Pain Medication Taken Per Day||Average of 3 days after surgery||||mg/day morphine equivalant||Standard Deviation|Mean
1252174|NCT00492284|Secondary|Mean Change From Baseline in Lesion Size|Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion|Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||micron||Standard Deviation|Mean
1252075|NCT00492973|Primary|Knee Society Scores|The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.|3 months postoperative||||units on a scale||Standard Deviation|Mean
1252076|NCT00492973|Primary|Knee Range of Motion||3 months||||degrees||Standard Deviation|Mean
1252077|NCT00492973|Primary|Length of Hospital Stay||days after surgery||||days||Standard Deviation|Mean
1252078|NCT00492921|Primary|GVHD Response Rate|Percentage of patients whose GVHD (as defined by Przepiorka criteria) responded to cyclophosphamide (complete response). Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).|Day 28|This analysis excludes the two participants who died early because their responses were not assessed prior to death.|||Participants|||Count of Participants
1252079|NCT00492921|Primary|Maximum Tolerated Dose of High-dose Cyclophosphamide as Determined by Number of Participants Who Tolerated Each Dose of Cyclophosphamide||Day 28||||Participants|||Count of Participants
1252080|NCT00492856|Primary|3-year Disease-free Survival (DFS) Rate|DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient > 10^-5 based on RT-PCR performed at appropriate central lab.|Up to 3 years|Eligible patients in molecular remission after receiving consolidation and randomized to either maintenance chemotherapy or observation. As of 8/15/10, all eligible patients were non-randomly assigned to receive maintenance chemotherapy. Only those that were randomized to either maintenance treatment or observation were included.|||percentage of patients|||Number
1252081|NCT00492856|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. Only adverse events that are possibly, probably, or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.|||Participants|||Number
1252082|NCT00492752|Secondary|Time of Maximum Concentration (Tmax) After 21 Days of Sorafenib Treatment|Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||hours||Full Range|Median
1252083|NCT00492752|Secondary|Normalized Maximum Concentration (Cmaxnorm) After 21 Days of Sorafenib Treatment|Cmaxnorm refers to the maximum plasma concentration of Sorafenib corrected for dose and body weight (Cmaxnorm = Cmax/(mg/kg)).|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||g/mL||Full Range|Geometric Mean
1252084|NCT00492752|Secondary|Maximum Concentration (Cmax) After 21 Days of Sorafenib Treatment|Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||mg/L||Full Range|Geometric Mean
1252085|NCT00492752|Secondary|Normalized Area Under the Curve (AUC Norm) After 21 Days of Sorafenib Treatment|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||g*h/L||Full Range|Geometric Mean
1252086|NCT00492752|Secondary|Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) After 21 Days of Sorafenib Treatment|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||mg*h/L||Full Range|Geometric Mean
1252087|NCT00492752|Secondary|Time to Response|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) ) was defined as the time from date of randomization to the earliest date that the response was first documented.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|The time to response was measured for the ITT population.|||days||Full Range|Median
1252088|NCT00492752|Secondary|Duration of Response|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented, or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last tumor assessment.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|The duration of response was measured for the ITT population.|||days||Full Range|Median
1252089|NCT00492752|Secondary|Number of Participants With Different Tumor Response|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed* Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization/start of treatment of the first subject until approximately 23 months after randomization when the subjects on placebo were offered the option to crossover to sorafenib treatment|The tumor response was measured for the ITT population.|||participants|||Number
1252090|NCT00492752|Secondary|Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Score From Baseline to Cycle 3 and End of Treatment|"The FACT-Hep questionnaire was also completed to assess patient reported outcome. The FACT-Hep assesses hepatobiliary cancer-related quality of life. FACT-Hep total score ranges from 0 to 180 (0=All questions answered Not at all; 180=All questions answered Very much)."|Baseline up to Cycle 3 and end of treatment. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|FACT-Hep score changes from baseline by visit were assessed for the ITT population.|||scores on a scale||Standard Deviation|Mean
1252091|NCT00492752|Secondary|Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) Score From Baseline to Cycle 1 and Cycle 3|The FHSI-8 questionnaire was completed at baseline and every 3 weeks during treatment and at the end of treatment visit only for subjects who withdrew for reasons other than symptomatic progression. Patient reported outcome was measured using the FHSI-8 score changes from baseline throughout the study period. FHSI-8 assesses hepatobiliary cancer symptoms with total score ranges from 0 to 32 (0 = the best quality of life; 32 = the worst quality of life with severe symptoms)..|Baseline up to Cycle 1 and Cycle 3. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|FHSI-8 score changes from baseline by visit were assessed for the ITT population.|||scores on a scale||Standard Deviation|Mean
1252092|NCT00492752|Secondary|Disease Control|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD: an increase in the sum of tumor lesions sizes) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR: disappearance of tumor lesions) + total number of Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes) + total number of Stable Disease (SD: steady state of disease); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating).|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Disease control rate was measured for the ITT population (all randomized subjects)|||participants|||Number
1252093|NCT00492752|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to radiologically documented disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation。|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Time to progression was measured for the ITT population (all randomized subjects) up to the data cut-off date of 09 Aug 2007 (23 months after randomization).|||days||95% Confidence Interval|Median
1252094|NCT00492752|Secondary|Time to Symptomatic Progression (TTSP)|Time to Symptomatic Progression (TTSP) was defined as the time from date of randomization to symptomatic progression. Subjects without symptomatic progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Time to Symptomatic Progression was measured for the ITT population (all randomized subjects) up to the data cut-off date of of 09 Aug 2007 (23 months after randomization)|||days||95% Confidence Interval|Median
1252095|NCT00492752|Primary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 09 Aug 2007 (23 months after randomization).|||days||95% Confidence Interval|Median
1252096|NCT00492726|Secondary|Duration of Hospitalization Postoperatively|Duration of hospitalization after the first surgery until discharge in the per protocol population.|Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)|Numbers refer to patients in the per protocol population with known end of hospitalization date.|||days||Standard Deviation|Mean
1252097|NCT00492726|Secondary|Duration of Hospitalization|Duration of hospitalization in the per protocol population.|From the first admission date to the discharge date (from 4 to 71 days after start of study medication)|Numbers refer to patients in the per protocol population with known end of hospitalization date.|||days||Standard Deviation|Mean
1252098|NCT00492726|Secondary|Number of Subjects Who Died Due to Intra-abdominal Infections|Number of subjects who had died due to intra abdominal infections by the time of TOC visit.|21 - 28 days after end of treatment at TOC Visit|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.|||participants|||Number
1252099|NCT00492726|Secondary|Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)|Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.|21 - 28 days after end of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).|||participants|||Number
1252100|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’ – additionally, any recurrence or reinfection was treated as bacteriological failure at TOC.|21 - 28 days after end of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).|||participants|||Number
1252101|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’.|After 5 - 14 days of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). For one patient in the Moxifloxacin group, the data is missing due to missing EOT visit (not displayed in the table below).|||participants|||Number
1252102|NCT00492726|Secondary|Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population|Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.|after 5 - 14 days of therapy|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.|||participants|||Number
1252103|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’.|During treatment at day 5 +/- 1 day|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).|||participants|||Number
1252104|NCT00492726|Secondary|Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population|Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.|During treatment at day 5 +/- 1 day|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.|||participants|||Number
1252105|NCT00492726|Primary|Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.|21 to 28 days after completion of study drug therapy|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subjects with no major protocol deviations that would have influenced the primary outcome.|||participants|||Number
1252106|NCT00492648|Secondary|Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes|This assay tabulated the number of subjects with clinically diagnosed HZ episodes, defined as any cutaneous HZ-like rash.|From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.|The analysis was performed on the Total cohort for persistence which included all subjects previously primed with 2 doses of GSK1437173A and were enrolled in the current study.|||Participants|||Count of Participants
1252107|NCT00492648|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|From Month 30 to study end Month 42 after the first vaccination|The analysis was performed on the Total cohort for persistence which included all subjects previously primed with 2 doses of GSK1437173A and were enrolled in the current study.|||Participants|||Count of Participants
1252108|NCT00492648|Secondary|Frequencies of VZV-specific Memory B Cells|As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.|At months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||VZV-specific B-cells/million B-cells||Standard Deviation|Mean
1252109|NCT00492648|Secondary|Frequencies of gE-specific Memory B Cells|As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.|At months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||gE-specific B-cells/million B-cells||Standard Deviation|Mean
1252110|NCT00492648|Secondary|Anti-VZV Ab Concentrations|As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).|At months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1252111|NCT00492648|Secondary|Anti-gE Antibody (Ab) Concentrations|As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).|At months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1252112|NCT00492648|Secondary|Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression.|The analysis focused on those gE- and VZV-specific CD4 T cells secreting any cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE or VZV was performed, since no long-term vaccine effect on gE- and VZV-specific CD8 T cell response was detected.|At Months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||CD4 cells/million T-cells||Standard Deviation|Mean
1252113|NCT00492648|Primary|Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).|"The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS).~No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected."|At Month 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||VZV-specific CD4 cells/million CD4 cells||Standard Deviation|Mean
1252114|NCT00492648|Primary|Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).|"The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS).~No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected."|At Month 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||gE-specific CD4 cells/million CD4 cells||Standard Deviation|Mean
1252115|NCT00492648|Primary|Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).|"The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS).~No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected."|At Month 30 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||VZV-specific CD4 cells/million CD4 cells||Standard Deviation|Mean
1252116|NCT00492648|Primary|Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L).|"The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, and CD40L as determined by intracellular cytokine staining (ICS).~No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected."|At Month 30 after the first vaccination.|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||gE-specific CD4 cells/million CD4 cells||Standard Deviation|Mean
1252117|NCT00492622|Primary|Area Under the Curve for Omeprazole Plasma Concentration|The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.|0 to 5 hrs after the study drug was ingested on treatment day 7|the AUC for each formulation were combined regardless of order given|||mg*h/mL||Standard Deviation|Mean
1252118|NCT00492622|Primary|Maximal Concentration of Omerazole|Maximal concentration of immediate-release vs. delayed-release omeprazole|10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment|All subjects were included, regardless of which formulation they received first.|||ng/mL plasma||Standard Deviation|Mean
1252119|NCT00492622|Primary|Time to Maximal Omeprazole Concentration (Tmax)|Time to max concentration for Immediate release vs. Delayed release omeprazole|10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment|All subjects were included regardless of which formulation they received first.|||minutes||Standard Deviation|Mean
1252120|NCT00492583|Primary|Number of Days Children Are Out of School Sick|"Outcome measure, number of days children are out of school sick was measured for the entire population"|90 days||||days per 100 person days|||Number
1252121|NCT00492557|Post-Hoc|13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)|Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of a subset of participants using a microcolony OPA (mcOPA) assay.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. n= number of participants with a determinate OPA antibody titer to the given serotype.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1261108|NCT00425269|Secondary|C-peptide, 0-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
1252122|NCT00492557|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events|Systemic events (Any fever >= 38 degrees Celsius [C]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category.|Days 1 through 14 after 13vPnC vaccination|Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.|||Percentage of participants|||Number
1252123|NCT00492557|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions|Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder).|Days 1 through 14 after 13vPnC vaccination|Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.|||percentage of participants|||Number
1252124|NCT00492557|Primary|13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)|IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
1252125|NCT00492557|Primary|TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)|Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.|Baseline and 1 month after TIV vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1252126|NCT00492544|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|"Abnormalities include values outside (above or below) the normal ranges.~Normal ranges:~alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL"|At Day 0 and Month 7||||Participants|||Count of Participants
1252127|NCT00492544|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7||||Participants|||Count of Participants
1252128|NCT00492544|Secondary|Outcome of All Pregnancies|According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.|Up to Month 7|There were no pregnancies reported between Day 0 and Month 7 in the Total Vaccinated Cohort.||||||
1252129|NCT00492544|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.|From Day 0 up to Month 7||||Participants|||Count of Participants
1252130|NCT00492544|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day (Days 0-29) period following each vaccination||||Participants|||Count of Participants
1252131|NCT00492544|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination||||Participants|||Count of Participants
1252132|NCT00492544|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day (Days 0-6) period following each vaccination||||Participants|||Count of Participants
1252133|NCT00492544|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|Before vaccination (PRE) and one month post Dose 3 (Month 7)|Analysis was performed on the ATP cohort for immunogenicity.|||titer||95% Confidence Interval|Geometric Mean
1252134|NCT00492544|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|One month post Dose 3 (Month 7)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.|||Participants|||Count of Participants
1252135|NCT00492531|Primary|Change in Exercise Capacity as Assessed by 6 Minute Walk.|The primary outcome measure was change in exercise capacity assessed by 6 minute walk distance in meters from baseline to 16 weeks. Subjects without a week 16 assessment had their last observation carried forward.|Baseline to week 16/Imputed last visit.|All efficacy and safety analyses were conducted on the intent-to-treat (ITT) population, defined as all randomized subjects, regardless of therapy received. Pre-defined imputation rules:A value of 0 meters was imputed for subjects who died during the MIT.Subjects without a week 16 assessment had their last observation carried forward (LOCF).|||meters||Standard Deviation|Mean
1252136|NCT00492531|Secondary|Brain Natriuretic Peptide(BNP)Levels.||16 weeks||||pg/dl||Standard Deviation|Mean
1252137|NCT00492531|Secondary|Borg Dyspnea Score|Borg dyspnea score was used to measure the level of severity of breathlessness perceived by the patient before and after 6 minute walk. The severity is measured on a 10 point scale with 0= nothing at all and 10=maximum severity of breathlessness.|baseline to 16 weeks||||Score on a scale||Standard Deviation|Mean
1252138|NCT00492531|Secondary|Change From Baseline in Pulmonary Hypertension at Week 16 as Assessed by Tricuspid Regurgitant Jet Velocity|Secondary outcome measure was change from baseline in Pulmonary hypertension at week 16 as assessed by Tricuspid regurgitant jet velocity(TRV). Tricuspid regurgitant jet velocity was measured by transthoracic Doppler Echocardiography.|16 weeks||||meters/second||Standard Deviation|Mean
1252139|NCT00492401|Secondary|Measurement of Gene Expression in Peripheral Blood or Bone Marrow|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to day 28 of course 1|Data was not collected and analyzed for this trial||||||
1252140|NCT00492401|Secondary|Measurement of HbF in Peripheral Blood or Marrow Cells|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to days 28 of course 2|Data was not collected and analyzed for this trial||||||
1252141|NCT00492401|Secondary|Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells|Expression studies were conducted using quantitative RT PCR. Expression of DNMT were normalized to the internal control to the ABL and levels of miR-29 to RNA U44.|Pre treatment|Only pre treatment samples available for testing for 23 patients|||delta delta CT values||Inter-Quartile Range|Median
1252142|NCT00492401|Secondary|Measurement of DNA Methylation in Peripheral Blood or Bone Marrow Cells|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to day 28 of course 1|Data was not collected and analyzed||||||
1252143|NCT00492401|Primary|Rate of Complete Remission|Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul. Complete Remission Rate (CRm + CRi)|Up to 24 weeks||||patients|||Number
1252144|NCT00492349|Primary|P50|P50 response is a measure of the amplitude of the brain wave in response to a sound, where the positive going amplitude of the brain wave occurring at about 50 milliseconds after the sound. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 0, Week 2 and Week 8||||microvolts||Standard Error|Mean
1252145|NCT00492349|Primary|Antisaccade Error Rates|In antisaccade, participants were asked to focus on a central target. When a peripheral cue was presented, participants were asked to look in an equidistant and opposite direction of the peripheral cue. The error rate is calculated as the number of trials in which the participant looked toward the cue, rather than in the opposite direction, divided by the total number of trials. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 0, Week 2 and Week 8||||percentage errors||Standard Deviation|Mean
1252146|NCT00492349|Primary|Conner's Continuous Performance Test (CPT) Detectability Score|Conner's CPT Detectability Score (no set normal range, higher is generally better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 0, Week 2 and Week 8||||units on a scale||Standard Deviation|Mean
1252147|NCT00492349|Primary|Digit Symbol Test|Digit symbol test score (0 to no definite upper range, higher score is better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 0, Week 2 and Week 8||||units on a scale||Standard Deviation|Mean
1252148|NCT00492349|Primary|Maintenance Pursuit Gain|Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Eye velocity during the regular eye-tracking period (without foveal stabilization) divided by target velocity was used to calculate the maintenance pursuit gain. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 8||||velocity ratio||Standard Error|Mean
1252149|NCT00492349|Primary|Predictive Pursuit Gain|Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Participants are asked to track a target with their eyes. Participants may use a predictive mechanism to perform the tracking. The pursuit gain using the predictive mechanism is calculated. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 8||||velocity ratio||Standard Error|Mean
1252150|NCT00492349|Primary|Memory Saccadic Positional Error, Degrees|A saccade is a quick eye movement. Spatial working memory was assessed by memory saccade. Participants were asked to focus on a target while a peripheral cue was flashed. Participants were signaled to look in the direction of the peripheral cue when the central target was removed, and the positional error was calculated as the distance between the saccadic and peripheral target positions. Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 8||||degrees||Standard Error|Mean
1252151|NCT00492349|Primary|Hamilton Depression Rating Scale (Ham-D)|Ham-D Total Score (range 0 to 54, higher score is worse). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 8||||units on a scale||Standard Error|Mean
1252152|NCT00492336|Secondary|Number of Participants Exhibiting Side Effects|"The Side Effect Checklist (SEC) was used to assess side effects. The SEC is comprised of 22 common side effects, which are rated on a 1 (none)-4 (severe) scale. Side effects are determined to be clinically significant if there is a two or more point increase in severity from baseline, or any side effect that receives a severity rating of 4 (severe) at any point in the treatment phase of the study."|Every week for 12 weeks|One placebo patient for whom a baseline side effects checklist was excluded from these analyses.|||Participants|||Count of Participants
1261109|NCT00425269|Secondary|HbA1c, Baseline||baseline||||percent of Hb||95% Confidence Interval|Mean
1252153|NCT00492336|Secondary|Global Change in Illness Severity|"The Clinical Global Impression (CGI) severity of illness item was used to assess global changes. Scores on this item range from 1=Normal, not at all ill to 7=Among the most extremely ill."|Every 4 weeks for 12 weeks.|Number of participants available for symptom efficacy analyses.|||units on a scale||Standard Deviation|Mean
1252154|NCT00492336|Secondary|Depressive Symptoms|The Calgary Depression Scale (CDS; Addington et al, 1997) total score was used to assess depressive symptoms over the course of the study. Total scores were calculated by summing the scores of each of the 9 items. Total scores can range from 0-27, with higher scores indicating more severe depressive symptoms.|Every 4 weeks for 12 weeks.|Number of participants available for symptom efficacy analyses.|||units on a scale||Standard Deviation|Mean
1252155|NCT00492336|Secondary|Change in Persistent Positive Symptoms|"The Brief Psychiatric Rating Scale (BPRS) positive symptom item total score was used to assess positive symptom change. The BPRS positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating."|Every 4 weeks for 12 weeks.|Number of participants available for symptom efficacy analyses.|||units on a scale||Standard Deviation|Mean
1252156|NCT00492336|Secondary|Number of Participants With Akathisia|The Barnes Akathisia Scale (BAS; Barnes, 1989) was used to assess akathisia, a type of extrapyramidal symptom. The global clinical assessment of akathisia score is rated on a scale from 0=Absent to 5=Severe Akathisia.|Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.|Barnes Akathisia Scales at baseline and end of study were collected for 26 participants each in the rasagiline and placebo groups. End of study ratings were collected at week 12, except for 4 placebo participants (1 participant each at weeks 3 and 6, and two at week 8).|||Participants|||Count of Participants
1252157|NCT00492336|Secondary|Extrapyramidal Symptoms|The Simpson Angus Scale (SAS; Simpson and Angus, 1970) was used to assess extrapyramidal symptoms (EPS). The assessment consists of 11 items, each rating the severity of potential symptoms of movement disorders. Total scores are calculated by summing the scores of each of the 11 items for a potential total score of 0-44, with higher scores indicating more severe EPS.|Baseline (Week 0) and End of Study (Week 12)|SAS scores were collected at baseline on 28 Rasagiline and 29 Placebo patients. End of study scores were collected on 27 Rasagiline and 27 Placebo patients, including 5 patients who withdrew before Week 12 (1 Rasagiline patient at Week 4, 1 Placebo participant each at Weeks 3 and 6, and two Placebo participants at Week 8).|||units on a scale||Standard Deviation|Mean
1252158|NCT00492336|Primary|Cognitive Testing - Delayed Discounting|The monetary choice questionnaire for hypothetical monetary rewards was used to assess delayed discounting (Kirby et al, 1999). The measure includes 27 items in which participants choose between a smaller, immediate reward (SIR) and a larger, delayed reward (LDR). There are three LDR sizes: small ($25-35), medium ($50-60) and large ($75-85). By examining the pattern of choices that participants make across the set of 27 items it is possible to calculate their delay discounting rate, termed K. The discount rate determines the steepness of the reduction in the present value of a reward with increases in the delay to the possible receipt of that reward. Thus, higher values in K represent greater discounting of the value of future rewards. With this measure K values can range between a low of 0.00016 to a high of 0.25. Higher K values have been linked to measures of impulsivity. Shown in the table are the K values observed when the future rewards were small, medium, or large.|Beginning of treatment phase (week 0) and end of treatment phase (week 12)|Subjects completing the cognitive testing at both time points.|||units on a scale||95% Confidence Interval|Geometric Mean
1252159|NCT00492336|Primary|Cognitive Testing - Probabilistic Learning Task|To assess reward learning, participants used performance feedback to choose the most frequently rewarded item in each of three pairs of stimuli (one pair had reward probabilities: 80% vs 20%; one pair had reward probabilities of 70% vs 30%; one pair had the probabilities of 60% vs 40 %) (PL; Frank et al, 2004). A total of 240 trials were administered so each pair was seen 80 times. Higher scores represent more frequent choices of the optimal stimulus in each pair. The frequencies with which participants repeated an item choice that was rewarded on the previous presentation (win-stay) is also presented as a percentage. Similarly, the lose-shift score is the percentage of times that participants changed their choice for unrewarded items (lose-shift). The win-stay score serves as a measure of the impact of positive feedback on subsequent choices while the lost-shift score serves as a measure of the impact of negative feedback on subsequent choices.|Beginning of treatment phase (week 0) and end of treatment phase (week 12)|Subjects completing the cognitive testing at both time points. Results for lose shifts are calculated for 24 Rasagiline and 22 Placebo participants, due to missing data created by participants who had zero losses (and hence no need to shift) during both the 3rd and 4th blocks of trials.|||percentage of optimal stimuli chosen||Standard Deviation|Mean
1252160|NCT00492336|Primary|Cognitive Testing - N-Back Neurocognitive Task|The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.|Beginning of treatment phase (week 0) and end of treatment phase (week 12)|Subjects completing the cognitive testing at both time points.|||units on a scale||Standard Deviation|Mean
1252161|NCT00492336|Primary|Cognitive Testing - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score|The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.|Beginning of treatment phase (week 0) and end of treatment phase (week 12)|Subjects completing the cognitive testing at both time points.|||units on a scale||Standard Deviation|Mean
1252175|NCT00492284|Secondary|Mean Change From Baseline in Central Retinal Thickness||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||micron||Standard Deviation|Mean
1252176|NCT00492284|Secondary|Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||Percentage of participants||95% Confidence Interval|Mean
1252162|NCT00492336|Primary|Change in Negative Symptoms|"The Scale for the Assessment of Negative Symptoms (SANS) rating scale was used to assess the negative symptoms of schizophrenia. Scores on the subscales are combined (summed) to compute a total score. There are a total of 17 subscales. Each subscale ranges from 0=Not at all to 5=Severe. Every 4 weeks the summed subscale scores provide a total score for that week (0-85). Higher scores indicate more severe negative symptoms."|Every 4 weeks over a 12 week period|Number of participants available for symptom efficacy analyses.|||units on a scale||Standard Deviation|Mean
1252163|NCT00492297|Secondary|Time to Progression|Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD.|From start of treatment until progression (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Of these 83, 78 were included in this analysis.|||days||95% Confidence Interval|Median
1252164|NCT00492297|Secondary|Time to Response|Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented.|start of therapy to confirmed CR or PR (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis.|||days||95% Confidence Interval|Median
1252165|NCT00492297|Secondary|Duration of Stable Disease|Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment.|from start of therapy to PD, only in non-responders (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 70 subjects who had a Best Response of Stable Disease, ie, those who failed to achieve a Best Response of CR or PR, were included in this analysis.|||days||95% Confidence Interval|Median
1252166|NCT00492297|Secondary|Disease Control (DC)|DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point.|after start of treatment, at 6 months and 12 months|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.|||participants|||Number
1252167|NCT00492297|Secondary|Duration of Partial Response|Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).|from confirmed PR until PD (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 9 subjects who had a PR were included in this analysis.|||days||95% Confidence Interval|Median
1252168|NCT00492297|Secondary|Duration of Complete Response|Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).|from confirmed CR until PD (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 1 subject who had a CR was included in this analysis (duration 420 days, censored).|||days|||Number
1252169|NCT00492297|Secondary|Duration of Response|Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment.|from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis.|||days||Full Range|Median
1252170|NCT00492297|Secondary|Overall Survival|Overall Survival was the number of days from the date that combination treatment started until the date of death.|from start of treatment until death (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.|||days||95% Confidence Interval|Median
1252171|NCT00492297|Secondary|Percentage of Subjects With Progression-free Survival at Specific Time-points|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|from start of treatment until progression or death before progression after 3, 6 and 12 months|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.|||percentage of participants|||Number
1252172|NCT00492297|Secondary|Progression-free Survival|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|from start of treatment until progression or death before progression (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.|||days||95% Confidence Interval|Median
1252173|NCT00492297|Primary|Overall Best Response|Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions.|during or within 30 days after active therapy|There were 83 subjects in the intent-to-treat (ITT) population. Of these, 75 were evaluable for Best Response; 8 were not evaluable.|||participants|||Number
1252177|NCT00492284|Secondary|Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||Percentage of participants||95% Confidence Interval|Mean
1252178|NCT00492284|Secondary|Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||Percentage of participants||95% Confidence Interval|Mean
1252179|NCT00492284|Secondary|Mean Change From Baseline in Study Eye Best-Corrected VA Score|Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100|Baseline to Month 24||||Letters read on ETDRS chart||95% Confidence Interval|Mean
1252180|NCT00492284|Secondary|Mean Number of Retreatments (Day 0 Excluded)|Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.|Month 1 to Month 24|Intent-to-treat|||number of retreatments||95% Confidence Interval|Mean
1252181|NCT00492284|Primary|Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)|Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100|Baseline to Month 12|Intent-to-treat and last observation carried forward|||Letters read on ETDRS chart||95% Confidence Interval|Mean
1252182|NCT00492284|Primary|Mean Number of Retreatments (Day 0 Excluded)|Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.|Month 1 to Month 12|Intent-to-treat|||number of retreatments||95% Confidence Interval|Mean
1252183|NCT00492232|Secondary|Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period|Participants who achieved a 50% reduction in zolpidem dosage at any previously defined 2-week period (ie, reduction phase) during the DBTP were summarized. The reduction in dosage at any time=[1-(reduction phase weekly dosage/baseline weekly dosage)]*100%.|Baseline and Weeks 1-10|Analysis was performed on all subjects who were randomized and received at least 1 dose of double-blind medication during the study. Subjects were analyzed by the treatment they were randomized to receive.|||participants|||Number
1252184|NCT00492232|Secondary|Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period|Participants who achieved a 50% reduction in zolpidem dosage (or frequency) at the end of the DBTP (ie, the end of Reduction Phase 4) were summarized. The reduction in dosage at Reduction Phase 4=[1-(Reduction Phase 4 weekly dosage/baseline weekly dosage)]*100%.|Baseline and Week 10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||participants|||Number
1252185|NCT00492232|Secondary|Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation|Participants who took no zolpidem during the last 7 days of the DBTP were completely discontinued from zolpidem. Participants who completely discontinued zolpidem via reduction in zolpidem use frequency (alone) were not summarized.|Weeks 1-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, had completed the DBTP, and had sufficient zolpidem dosage data in the last 7 days of the DBTP. Estimates could not be reported with correct statistical inference due to small sample sizes by method of discontinuation (ie, most subjects reduced zolpidem dose).|||participants|||Number
1252186|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10|The number of nights zolpidem was taken was recorded during Weeks 9-10 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Baseline and Weeks 9-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
1252187|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8|The number of nights zolpidem was taken was recorded during Weeks 7-8 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Baseline and Weeks 7-8|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
1252188|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6|The number of nights zolpidem was taken was recorded during Weeks 5-6 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Weeks 5-6|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
1252189|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4|The number of nights zolpidem was taken was recorded during Weeks 3-4 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Weeks 3-4|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
1252190|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2|The number of nights zolpidem was taken was recorded during Weeks 1-2 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from BL were summarized.|Baseline and Weeks 1-2|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
1252191|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10|Dosages of zolpidem taken were recorded during Weeks 9-10 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 9-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
1252192|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8|Dosages of zolpidem taken were recorded during Weeks 7-8 of the double blind period. Differences in dosages from baseline were summarized.|Baseline and Weeks 7-8|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
1252193|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6|Dosages of zolpidem taken were recorded during Weeks 5-6 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 5-6|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
1252194|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4|Dosages of zolpidem taken were recorded during Weeks 3-4 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 3-4|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
1252195|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2|Dosages of zolpidem taken were recorded during Weeks 1-2 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 1-2|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
1252196|NCT00492232|Primary|Percentage of Participants Who Discontinued Zolpidem Therapy|Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.|Week 10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Percentage of participants|||Number
1252197|NCT00492206|Secondary|EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase|EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.|approx. 5 years|Participants with baseline tumor tissue available for EGFR status analysis by fluorescence in situ hybridization (FISH). Akt, pAkt, and MAPKinase analyses were not conducted.|||percentage of tumors|baseline tumor tissue||Number
1252198|NCT00492206|Secondary|Best Overall Response Rate (ORR) (Number of Participants)|The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 12 weeks after treatment initiation|Patients who received concurrent radiotherapy + cetuximab + consolidation therapy, and patients who did not receive cetuximab|||participants|||Number
1252199|NCT00492206|Secondary|Progression-free Survival (PFS)|Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 36 months|Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC.|||months||95% Confidence Interval|Median
1252200|NCT00492206|Primary|Overall Survival (OS)||Up to 36 months|Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC (N = 38).|||months||95% Confidence Interval|Median
1252201|NCT00492115|Secondary|Sleep Stages; %Time Spent at SaO2<90%;|Overnight sleep studies were done to examine the effect of CPAP treatment on sleep stages and on %time spent at Sa)2<90%.|6 weeks||||Percent time spent at low oxygen <90%||Standard Deviation|Mean
1252202|NCT00492115|Primary|Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep)|Overnight sleep studies were done to determine the effect of treatment on the apnea-hypopnea index (number of apneas and hypopneas per hour of sleep)|six weeks||||apnea hypopnea index||Standard Deviation|Mean
1252203|NCT00492089|Primary|Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment|Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.|Baseline to 12 weeks|Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.|||participants|||Number
1252204|NCT00492063|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination|The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.|Up to 7 days postvaccination|Analysis was done on Safety population i.e., all subjects with vaccination and with some post-baseline safety data.|||Number of Subjects|||Number
1252205|NCT00492063|Primary|Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV|Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.|Three weeks after vaccination (day 22)|Analysis was performed on the PP set.|||Ratio||95% Confidence Interval|Number
1252206|NCT00492063|Primary|Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV|Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.|Three weeks after vaccination (day 22)|Analysis was performed on the PP set.|||Percentages||95% Confidence Interval|Number
1252207|NCT00492063|Primary|Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines|"Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay.~In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group."|Before vaccination (day 1) and three weeks after vaccination (day 22)|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccination correctly; provided evaluable data before and after vaccination; and with no major protocol violations, as defined before unblinding.|||Percentages||95% Confidence Interval|Number
1252208|NCT00492024|Other Pre-specified|Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))|The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.|At 'Test-of-Cure', Day 1-5 after end of treatment|This analysis population was per protocol population, which included all subjects with at least one pre-treatment causative organism, and who had no major deviations from the protocol procedures.|||Percentage of subjects|||Number
1252209|NCT00492024|Secondary|Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up|A secondary efficacy variable was clinical response (CR) at the Follow-up visit 17-21 days following the start of treatment. CR was rated as continued cure, failure/relapse, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.|Day 12 to 26 after end of treatment|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.|||Percentage of subjects|||Number
1252210|NCT00492024|Secondary|Percentage of Subjects With Clinical Improvement During Therapy|A secondary efficacy variable was clinical response (CR) at the During Therapy visit at day 3 or 4 of treatment. CR was rated as improvement, cure, failure, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.|Day 3 of treatment|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. Missing responses at during therapy visit in most cases was due to early clinical failure.|||Percentage of subjects|||Number
1252211|NCT00492024|Secondary|Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach|The Activity Impairment Assessment (AIA) questionnaire was used to assess activity impairment at baseline and time to return to normal activities. The AIA was administered prior to first dose, every 24 hours during treatment, and at the TOC visit. Improvement in the AIA total score was defined as a decrease of at least 3 units.|Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.|||participants|||Number
1252212|NCT00492024|Secondary|Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach|The Sino-Nasal Outcome Test (SNOT-16) was used to assess subject-reported time to symptom improvement. Improvement was defined as a decrease of at least 14 units on the test. This difference is the smallest difference that has been identified as beneficial to subjects.|Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.|||participants|||Number
1252213|NCT00492024|Primary|Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))|The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.|At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment|The modified intent-to-treat (MITT) population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.|||Percentage of subjects|||Number
1252239|NCT00491556|Secondary|Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Three subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 22 participants.|||percentage of CD8 TemRA CD28 cells||Standard Deviation|Mean
1252214|NCT00491894|Secondary|Investigator's Global Assessment of Treatment|The investigator performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The investigator selected one of the following choices to assess if ‘This is a worthwhile treatment’: 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories ‘responder’ (strongly agree and agree responses aggregated) and ‘non-responder’ (neutral, disagree, and strongly disagree responses aggregated)|Week 24|The analysis for investigator's Global Assessment was done by intention to treat method|||Participants|||Number
1252215|NCT00491894|Secondary|Parent/Caregiver's Global Assessment of Treatment|The parent/caregiver performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The parent/caregiver selected one of the following choices to assess if ‘This is a worthwhile treatment’: 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories ‘responder’ (strongly agree and agree responses aggregated) and ‘non-responder’(neutral, disagree, and strongly disagree responses aggregated)|Week 24|The analysis for parent/caregiver's Global Assessment was done by intention to treat method|||Participants|||Number
1252216|NCT00491894|Secondary|Parent/Caregiver's Assessment of the Extent of Drooling Using VAS|Parents/caregivers were to complete a 10 cm “Parent/Caregiver’s Assessment of Extent of Drooling for the Day” VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.|Week 24||||VAS score||Standard Deviation|Mean
1252217|NCT00491894|Secondary|Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)|Parents/caregivers were to complete a 10 cm “Parent/Caregiver’s Assessment of Extent of Drooling for the Day” VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.|Baseline||||VAS score||Standard Deviation|Mean
1252218|NCT00491894|Primary|Proportion of Responders According to the Modified Teacher’s Drooling Scale (mTDS)|The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline|6 months|The analysis was done by intention to treat method. For purposes of statistical estimation, patients who dropped out due to lack of efficacy had their worst observation carried forward. Patients who dropped out for reasons other than lack of efficacy had their last observation carried forward|||Participants|||Number
1252219|NCT00491829|Primary|Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.|To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered “yes” to the eDiary question: “Was the event satisfying for you?”|baseline to 24 weeks|Patients who had at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). The FAS was used for primary analyses.|||events per month||Standard Deviation|Mean
1252220|NCT00491764|Secondary|Treatment Success of Onychomycosis at Week 48|Treatment success was defined as negative mycology (negative culture and negative KOH) and =<10% nail involvement.|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication|||Participants|||Number
1252221|NCT00491764|Secondary|Effective Treatment of Onychomycosis at Week 48.|Effective treatment is defined as negative mycology (negative culture and KOH) and either 0% nail involvement or >5 mm growth of unaffected nail|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication|||Participants|||Number
1252222|NCT00491764|Primary|Complete Cure of Onychomycosis at Week 48.|Complete cure is defined as negative mycology (negative culture and KOH [potassium hydroxide]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication|||Participants|||Number
1252223|NCT00491751|Secondary|Percentage Change in FMD in All Participants With and Without a CVD Event (Not by Treatment Group)|This outcome is independent of the treatment group so the groups are 'CVD event' and ' No CVD Event'. Cardiovascular events (CVD) included cardiovascular disease, myocardial infarction, congestive heart failure, stroke, and unstable angina.|2 months|For this outcome all participants were stratified into 2 groups: those with, and those without a CVD event (not by treatment group)|||percent change of flow-mediated dilation||Standard Deviation|Mean
1252224|NCT00491751|Primary|Change in FMD|Change in flow mediated dilation with treatment: FMD visit 2 - FMD visit 1 FMD is measured by using vascular ultrasound to determine the baseline diameter of the brachial artery. Endothelium-dependent vasodilation is induced by 5-minute arterial occlusion with a blood pressure cuff. When the cuff is released, the resultant increase in blood flow (reactive hyperemia) stimulates vasodilation of the brachial artery. This flow-mediated dilation (FMD) is expressed as the percent change from baseline. Healthy individuals typical dysplay a 10 to 12% dilation. Individuals with PAD had markedly impaired dilation of 6-7. The currernt study sought to determine whether a change in FMD would occur following intervention.|1-4 weeks|All enrolled subjects were analyzed.|||percent change of FMD||Standard Deviation|Mean
1252225|NCT00491738|Primary|All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)|Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.|5 months||||participants|||Number
1252240|NCT00491556|Secondary|Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo HLA-DR cells||Standard Deviation|Mean
1252226|NCT00491608|Secondary|Number of Participants With Clinically Significant Changes in Mean Values for Vital Signs (Temperature, Systolic Blood Pressure, Diastolic Blood Pressure, Respiration Rate, Heart Rate) at Baseline and Day 29|Laboratory findings considered clinically significant by investigator when associated with symptoms, required specific treatment, or required a change in participant management. Clinically significant changes in vital signs were reported as adverse events.|Baseline and Day 29 (end of study)|All participants who received at least 1 application of rThrombin during surgery.|||Participants|||Number
1252227|NCT00491608|Secondary|Number of Participants With Abnormal Laboratory Results in Median Levels of Immunoglobulin A, G, and M at Baseline or Day 29|Abnormal laboratory findings were recorded as AEs when the investigator considered them to be clinically significant (eg, an unusual result for the surgical population or for an individual participant) or when they were associated with symptoms or required treatment or a change in patient management.|Baseline and Day 29 (end of study)|All participants who received rThrombin and had both baseline and postbaseline antibody assessments available.|||Participants|||Number
1252228|NCT00491608|Secondary|Number of Participants With Elevations in Coagulation Parameters of CTC Grade 3 or Higher at Baseline and Day 29|Activated partial thromboplastin time (aPTT) elevations: Grade 3=>2*upper limit of normal (ULN). International normalized ratio(INR)elevations: Grade 3=>2*ULN. Changes in prothrombin time were not graded for toxicity. n=Number of participants with assessments available at that visit.|Baseline and Day 29 (end of study)|All participants who received at least 1 application of rThrombin during surgery and had laboratory test results available for assessment.|||Participants|||Number
1252229|NCT00491608|Secondary|Number of Participants With Abnormal Hematology Laboratory Results of Common Terminology Criteria (CTC) Grade 2 or Higher at Baseline and Day 29|Hemoglobin, low (g/L): Grade 2=<100 Grade 3=<80; Grade 4=<65. Platelets, low: Grade 2=<75*10^9/L; Grade 3=<50*10^9/L; Grade 4=<25*10^9/L. Leukocytes, low: Grade 2=<3.0-2.0*10^9/L; Grade 3=<2.0-1.0*10^9/L; Grade 4=<1.0*10^9/L. Lymphocytes, low: Grade 2=<0.8*10^9/L; Grade 3=<0.5*10^9/L; Grade 4=<0.2*10^9/L. Neutrophils, low: Grade 2=<1.5*10^9/L; Grade 3=<1.0*10^9/L; Grade 4=<0.5*10^9/L. Changes in hematocrit values observed were not graded for severity.|Baseline and Day 29 (end of study)|All participants who who received at least 1 application of rThrombin during surgery and had laboratory test results available for baseline and Day 29 visits.|||Participants|||Number
1252230|NCT00491608|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events, Treatment-related Adverse Events (AEs), and Treatment-emergent AEs|AE=a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE=an unfavorable medical event that results in death, persistent or significant incapacity, or drug dependency or abuse; is life-threatening, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to study drug. Treatment-emergent=onset on or after treatment start. Grade (Gr) 1=mild, Gr 2=moderate, Gr 3=severe, Gr 4=life threatening/disabling, Gr 5=death.|Day 1 (surgery) to Day 29 (end of study), continuously|All participants who received at least 1 application of rThrombin during surgery.|||Participants|||Number
1252231|NCT00491608|Primary|Number of Participants With Anti-recombinant Thrombin (rThrombin) Product Antibodies at Day 29 in Participants With and Without Anti-bovine Thrombin Product Antibodies at Baseline|Seropositive=with specific anti-bovine thrombin product antibodies; seronegative=without specific anti-bovine thrombin product antibodies.|At Day 29|Participants who received treatment with rThrombin and had results from both baseline and post-baseline antibody assessments|||Participants|||Number
1252232|NCT00491556|Secondary|Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa HLA-DR T cells||Standard Deviation|Mean
1252233|NCT00491556|Secondary|Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa HLA-DR T cells||Standard Deviation|Mean
1252234|NCT00491556|Secondary|Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD57cells||Standard Deviation|Mean
1252235|NCT00491556|Secondary|Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD57 cells||Standard Deviation|Mean
1252236|NCT00491556|Secondary|Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD38 cells||Standard Deviation|Mean
1252237|NCT00491556|Secondary|Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD38 cells||Standard Deviation|Mean
1252238|NCT00491556|Secondary|Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD28 cells||Standard Deviation|Mean
1252310|NCT00490945|Secondary|VEC-162 Cmax||Night 4||||ng/mL||Standard Deviation|Mean
1252241|NCT00491556|Secondary|Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRO HLADR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRO HLADR||Standard Deviation|Mean
1252242|NCT00491556|Secondary|Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD57 cells||Standard Deviation|Mean
1252243|NCT00491556|Secondary|Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD57 cells||Standard Deviation|Mean
1252244|NCT00491556|Secondary|Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD38 cells||Standard Deviation|Mean
1252245|NCT00491556|Secondary|Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD38 cells||Standard Deviation|Mean
1252246|NCT00491556|Secondary|Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD28 cells||Standard Deviation|Mean
1252247|NCT00491556|Secondary|Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD28 cells||Standard Deviation|Mean
1252248|NCT00491556|Secondary|Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM HLA-DR T cells||Standard Deviation|Mean
1252249|NCT00491556|Secondary|Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM HLA-DR T cells||Standard Deviation|Mean
1252250|NCT00491556|Secondary|Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD57 cells||Standard Deviation|Mean
1252251|NCT00491556|Secondary|Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD57 cells||Standard Deviation|Mean
1252252|NCT00491556|Secondary|Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD38 cells||Standard Deviation|Mean
1252253|NCT00491556|Secondary|Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD38 cells||Standard Deviation|Mean
1252254|NCT00491556|Secondary|Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD28 cells||Standard Deviation|Mean
1252255|NCT00491556|Secondary|Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD28 cells||Standard Deviation|Mean
1252256|NCT00491556|Secondary|Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing HLA-D, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve HLA-DR T cells||Standard Deviation|Mean
1252257|NCT00491556|Secondary|Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing Human Leukocyte Antigen-D related (HLA-DR), therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve HLA-DR T-cells||Standard Deviation|Mean
1252258|NCT00491556|Secondary|Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD57 cells||Standard Deviation|Mean
1252259|NCT00491556|Secondary|Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD57 cells||Standard Deviation|Mean
1252260|NCT00491556|Secondary|Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD38 cells||Standard Deviation|Mean
1252261|NCT00491556|Secondary|Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD38 cells||Standard Deviation|Mean
1252262|NCT00491556|Secondary|Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 Naïve CD28 Cells||Standard Deviation|Mean
1252263|NCT00491556|Secondary|Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD28 cells||Standard Deviation|Mean
1252264|NCT00491556|Secondary|Difference in CD8+ TEMRa Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
1252265|NCT00491556|Secondary|Difference in CD8+ TEMRa Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
1252266|NCT00491556|Secondary|Difference in CD8+ TEMRo Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TEMRo cells/cubic millimeter||Standard Deviation|Mean
1252267|NCT00491556|Secondary|Difference in CD8+ TEMRo Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TEMRo cells/cubic millimeter||Standard Deviation|Mean
1252268|NCT00491556|Secondary|Difference in CD8+ TCM Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TCM cells/cubic millimeter||Standard Deviation|Mean
1252269|NCT00491556|Secondary|Difference in CD8+ TCM Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TCM cells/cubic millimeter||Standard Deviation|Mean
1252270|NCT00491556|Secondary|Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ naïve T cells/cubic millimeter||Standard Deviation|Mean
1252271|NCT00491556|Secondary|Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
1252272|NCT00491556|Secondary|Difference in CD4+ TEMRa Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
1252273|NCT00491556|Secondary|Difference in CD4+ TEMRa Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
1252274|NCT00491556|Secondary|Difference in CD4+ TEMRo Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TemRo cells/cubic millimeter||Standard Deviation|Mean
1252275|NCT00491556|Secondary|Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ Effector Memory (TEM)Ro count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TemRo cells/cubic millimeter||Standard Deviation|Mean
1252276|NCT00491556|Secondary|Difference in CD4+ TCM Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TCM cells/cubic millimeter||Standard Deviation|Mean
1252277|NCT00491556|Secondary|Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Termed Central Memory (TCM) count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TCM cells/cubic millimeter||Standard Deviation|Mean
1252278|NCT00491556|Secondary|Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
1252279|NCT00491556|Secondary|Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
1252280|NCT00491556|Secondary|Difference in CD4+ T Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm|||CD4+ T cells/cubic millimeter||Standard Deviation|Mean
1252281|NCT00491556|Secondary|Difference in CD4+ T Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.|||CD4+ T cells/cubic millimeter||Standard Deviation|Mean
1252282|NCT00491556|Primary|Difference in CD4+ T Cell Percentage Between Week 48 and Week 152||152 Weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm|||percentage of CD4+ T cells||Standard Deviation|Mean
1252283|NCT00491556|Primary|Difference in CD4+ T Cell Percentage Between Week 0 and Week 48||Week 0 and Week 48|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized to the experimental arm.|||percentage of CD4+ T cells||Standard Deviation|Mean
1252284|NCT00491530|Secondary|Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 Total-C minus baseline Total-C)/baseline Total-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Standard Deviation|Mean
1252285|NCT00491530|Secondary|Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Standard Deviation|Mean
1252286|NCT00491530|Secondary|Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Standard Deviation|Mean
1252311|NCT00490945|Secondary|VEC-162 AUC||Night 4||||ng*hr/mL||Standard Deviation|Mean
1252312|NCT00490945|Secondary|Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)|"Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt.~Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2."|Night 2 and Night 4|*Placebo N = 7 and 100 mg VEC-162 N = 7|||minutes||Standard Deviation|Mean
1252287|NCT00491530|Secondary|Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Standard Deviation|Mean
1252288|NCT00491530|Secondary|Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at week 104 are included.|||percent change||Standard Deviation|Mean
1252289|NCT00491530|Secondary|Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 triglycerides minus baseline triglycerides)/baseline triglycerides] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Full Range|Median
1252290|NCT00491530|Primary|Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study|All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.|Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.|||percentage of participants|||Number
1252291|NCT00491504|Primary|Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1|Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time.|Baseline and 6 hours following initial dosing|Intent to treat population|||score on a scale||Standard Error|Least Squares Mean
1252292|NCT00491400|Secondary|Serum Lipids|Effect of the intervention on total cholesterol, HDL, and triglycerides|8 weeks|Enrollment was insufficient and there are too few subjects for meaningful analysis||||||
1252293|NCT00491400|Primary|Brachial Artery Flow-mediated Dilation|Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.|8 weeks|The number of participants is too few for meaningful analysis.||||||
1252294|NCT00491387|Primary|Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio|24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.|january 2018|||||||
1252295|NCT00491374|Primary|The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI)|||The primary outcome measure could not be assessed because no subject received randomized treatment assignment, or any treatment. The study was terminated.||||||Number
1252296|NCT00491322|Primary|Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units|Fibroblast growth factor 23 (FGF23) is a phosphate and vitamin D regulating hormone.|12 weeks||||pg/mL||Standard Deviation|Mean
1252297|NCT00491244|Secondary|Adverse Event (AE)-Related Withdrawal Rate||1.5 year|All patients were analyzed if they received at least one dose of the study medication; monitoring the events until the last visit|||participants|||Number
1252298|NCT00491244|Primary|Sustained Virologic Response (SVR)Rate||1.5 year|All participants were analyzed if they received at least one dose of the study medication|||participants|||Number
1252299|NCT00491179|Secondary|Number of Participants With Histologic Response(HR)|Number of participants with histologic response (HR): number of patients who had improvement of as least 2 scores at the end of follow-up liver biopsy compared to baseline liver biopsy by Ishak scoring system (the sum of Ishak necroinflammation score (0-18) and Ishak fibrosis score (0-6); the higher the total scores, the severer the histologic changes)|1.5 year||||Participants|||Number
1252326|NCT00490841|Secondary|Acute Procedure Success|Attainment of a final result of < 30% residual stenosis, as determined by the Angiographic Core Lab.|From beginning of index proceedure to end of index proceedure.||||percentage of participants|Participants|95% Confidence Interval|Number
1258639|NCT00442598|Primary|CA 125 Response Rate|Reduction in blood levels of CA 125 of >50% from baseline, confirmed at the next study cycle.|Duration of study, up to 18 weeks.||||participants|||Number
1252300|NCT00491179|Primary|1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs)|"Number of participants with sustained virologic response (SVR): number of patients with undetectable HCV RNA 6 months off therapy by real-time PCR test (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, limit of detection < 25 IU/mL)~Number of participants who droppoed out of the study prematurely due to adverse events (AEs): number of patients who prematurely withdrew from the study due to any adverse events"|1.5 year|Outcome measures:intention-to-treat (ITT) analysis Imputation technique: last observation carried forward|||Participants|||Number
1252301|NCT00491075|Primary|Overall Response|Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started.|Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks|One participant did not meet the required 16 week data end point and was excluded from the response evaluation and analysis.|||percentage of participants||95% Confidence Interval|Number
1252302|NCT00490971|Other Pre-specified|Clinical Global Impression - Bipolar Disorder - Severity of Illness (CGI-BP-S): Change From Baseline|The CGI-BP-S rating scale is used to rate the severity of bipolar disorder, including both depressed and manic components, on a 7-point scale ranging from 1 (not ill) to 7 (very severely ill). This scale permits a global evaluation of the subject’s bipolar condition at a given time. Negative Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat|||Scores on the scale||Full Range|Median
1252303|NCT00490971|Other Pre-specified|Global Assessment of Functioning (GAF): Change From Baseline|This scale is used when the clinical progress of a subject needs to be assessed in global terms, using a single measure. The GAF scale is rated with respect to psychological, social, and occupational functioning at the time of the assessment only. A higher score indicates a better functioning, with an overall range from 1 to 100. Positive Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat|||Scores on the scale||Standard Deviation|Mean
1252304|NCT00490971|Other Pre-specified|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS consists of 10 items covering all the important complaints which patient with depression have (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Item is scored from 0 (normal) to 6 (severe). Total score (0 to 60) is calculated by adding the scores of all 10 items. A higher score represents a more severe condition. Negative Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat|||Scores on the scale||Standard Deviation|Mean
1252305|NCT00490971|Other Pre-specified|Young Mania Rating Scale (YMRS): Change From Baseline|This is method by which condition of patient suffering with mania is checked. In this scale patient's condition is assessed using 11 items. A severity rating is assigned to each of 11 items based on the how subject feels of his or her condition and the physicians observation of patients behavior. The range of the scale is 0 to 60. A higher score indicates a more severe condition. Change from baseline (Day 105) in the double‑blind maintenance phase to the last postbaseline assessment.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat|||Scores on the scale||Standard Deviation|Mean
1252306|NCT00490971|Secondary|Time to Recurrence of Depressive Symptoms Associated With Bipolar I Disorder|Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of depressive symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.|Date of randomization into the maintenance phase until the first occurrence of recurrence of depressive symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set in MA period, which included participants who entered the maintenance phase and took at least 1 dose of study medication.|||Days||95% Confidence Interval|Number
1252307|NCT00490971|Secondary|Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder|This was the key secondary efficacy end-point. Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of manic symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.|Date of randomization into the maintenance phase until the first occurrence of recurrence of manic symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set in MA phase, which included participants who entered the MA phase and took at least 1 dose of study medication.|||Days||95% Confidence Interval|Number
1252308|NCT00490971|Primary|Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder|Time to first recurrence of any mood symptoms (ie, manic or depressive) associated with bipolar I disorder during the maintenance phase, after maintaining clinical stability during continued treatment with paliperidone ER over a period of 15 weeks. The time period was from occurrence of acute manic or mixed episode to Week 15. This outcome was measured using combination of various scales, hospitalization for any mood symptoms, use of any medicines for an mood episode and clinical events suggestive of recurrent mood episode associated with bipolar I disorder.|Date of randomization into the maintenance phase until the first occurrence of recurrence of any symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set (ITT) in maintenance (MA) phase, which included participants who entered the MA phase and took at least 1 dose of study medication.|||Days||95% Confidence Interval|Number
1252309|NCT00490945|Secondary|VEC-162 Tmax||Night 4||||hour||Standard Deviation|Mean
1252313|NCT00490945|Primary|Mean Sleep Efficiency|Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.|Night 4 and Night 2|"*N = 6 for 3rd Third of Night Efficiency and N=8 for 1st Third of Night Efficiency~**N = 7 for 3rd Third of Night Efficiency"|||% points||Standard Deviation|Mean
1252314|NCT00490945|Primary|Circadian Phase Shift|Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.|Night 3 and Night 4||||Hours||Standard Deviation|Mean
1252315|NCT00490919|Secondary|The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase|The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, 12 of double-blind phase|The full analysis population (FAP) (N = 541) consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. 2 subjects did not have safety data (N = 539).|||Units on a scale||Standard Deviation|Mean
1252316|NCT00490919|Secondary|The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase|Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.|weeks 2-12|Subjects in the full analysis population who took at least one dose of supplemental analgesic medication.|||tablets||Standard Error|Mean
1252317|NCT00490919|Primary|Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.|Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.|Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.|The full analysis population (FAP) (N = 541) [539] consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. (Two subjects did not have safety data.)|||Units on a scale||Standard Deviation|Mean
1252318|NCT00490841|Secondary|Renal Function (Measured by sCr)|"sCR= Serum Creatinine, per subject analysis. ITT. Renal function (measured by sCr) @ baseline: 1.2mg/dL (1.2, 1.3).~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.|||mg/dL||95% Confidence Interval|Mean
1252319|NCT00490841|Secondary|9 mo in Anti-hypertensive Medication In-take, ≥ 4 Medications|"Number of Anti-Hypertensive Medications taken at follow up compared to baseline, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to or greater than 4 Medications: 39.6%|||percentage of participants|||Number
1252320|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 3 Medications|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 3 Medications: 30.7%|||percentage of participants|||Number
1252321|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 2 Medications|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 2 medications: 29.2%|||percentage of participants|||Number
1252322|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 1 Medication|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 1 medication: 0.5%|||percentage of participants|||Number
1252323|NCT00490841|Secondary|Secondary Patency Rate of <60% Stenosis of the Target Lesion|"As determined by duplex ultrasound or angiography regardless of PTA, stenting, or bypass since index procedure. Rate reported as a percentage of participants with this condition.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.|||percentage of participants|Participants|95% Confidence Interval|Number
1252324|NCT00490841|Secondary|Primary Patency|"Defined as <60% stenosis without prior re-intervention, as determined by duplex ultrasound or angiogram.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.|||percentage of participants|Participants|95% Confidence Interval|Number
1252325|NCT00490841|Secondary|Acute Clinical Success|"Procedure success without Major Adverse Events (MAE)or access site event requiring surgical or percutaneous intervention prior to hospital discharge.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|From beginning of index proceedure to end of index proceedure.||||percentage of participants||95% Confidence Interval|Number
1255989|NCT00462605|Secondary|Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH)||Baseline and 6, 12, 24, and 36 weeks|Due to the limited number of clinical responders, the research assay was not done.||||||
1252327|NCT00490841|Secondary|Acute Device Success|Acute device success is defined as, on a per device basis, the achievement of successful delivery of the assigned device(s)as intended to the designated location.|From beginning of index procedure to end of index proceedure.||||percentage of devices|Participants|95% Confidence Interval|Number
1252328|NCT00490841|Secondary|9 Month Blood Pressure (Diastolic)|As compared to baseline. See Population description.|9 months and baseline|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||mmHg||95% Confidence Interval|Mean
1252329|NCT00490841|Secondary|9 Month Blood Pressure (Systolic)|As compared to baseline (pre-procedure). Blood pressure measurements at 9 months.|Baseline (Pre-Procedure) and 9 months|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||mmHg||95% Confidence Interval|Mean
1252330|NCT00490841|Secondary|Event Free Rate of Clinically Indicated Target Lesion Revascularization (TLR)|Event Free percentage: Defined as percentage of participants free from this event.|9 months|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||Event Free Percentage|||Number
1252331|NCT00490841|Secondary|Embolic Events Resulting in Kidney Damage|Percentage of participants with an embolic event resulting in kidney damage.|30 days|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of participants||95% Confidence Interval|Number
1252332|NCT00490841|Secondary|Ipsilateral Nephrectomy|Ipsilateral: Situated on or affecting the same side as treated. Nephrectomy: Removal of the affected kidney|30 days|intention to treat (ITT). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants||95% Confidence Interval|Number
1252333|NCT00490841|Secondary|Death for Any Reason||30 days|Non-Hierarchical Subject Counts, Per Subject Analysis (Intent-to-Treat Population). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants||95% Confidence Interval|Number
1252334|NCT00490841|Primary|Binary Restenosis Rate|Determined by duplex ultrasound or angiogram. Reported as the percentage of participants with occurance of binary restenosis.|9 months|Subject total reflects those who were evaluable at the time of analysis. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.|||Percentage of lesions|Participants|95% Confidence Interval|Number
1252335|NCT00490815|Secondary|Retinal Thickness||over 36 months||||µg||Standard Deviation|Mean
1252336|NCT00490815|Primary|Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor|This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.|over 36 months||||pg/ml||Standard Deviation|Mean
1252337|NCT00490802|Secondary|Social Responsiveness Scale|The Social Responsiveness Scale has been developed to measure autism related symptoms and focuses more on social function than social cognition. The Social Responsiveness Scale has been modified for adults by and we have obtained permission to use the adult scale, although it is not commercially available yet. The Social Responsiveness Scale measures social behaviors such as social awareness, information processing, and social motivation and yields a quantitative score that has been useful in endophenotype studies of Autism Spectrum Disorder. The minimum score that can be obtained is a 0 and the maximum raw score for subscales is 66, maximum total raw score is 153. A lower score represents a positive response.|6 Weeks||||units on a scale||Standard Deviation|Mean
1252338|NCT00490802|Secondary|Yale-Brown Obsessive-Compulsive Scale|The Yale-Brown Obsessive-Compulsive Scale is a clinician-rated questionnaire measuring the time spent, distress, interference, resistance, and control in relation to obsessions and compulsions based on a 5-point scale. This scale has excellent reliability and validity and is used as the gold standard to measure treatment challenges in all Obsessive-Compulsive Disorder clinical trials. The Yale-Brown Obsessive-Compulsive Scale Compulsion Subscale has been shown to be a reliable and valid scale in Autism Spectrum Disorder, and in measuring change in treatment studies of autism. The minimum score that can be obtained is 0 and the maximum score is 20. A lower score represents a positive response.|6 Weeks||||units on a scale||Standard Deviation|Mean
1252339|NCT00490802|Primary|Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test|The Diagnostic Analysis of Nonverbal Accuracy is a measure of emotion recognition across multiple modalities. It consists of five subtests: the Adult Facial Expression Test, the Child Facial Expression Test, the Adult Paralanguage Test, the Child Paralanguage Test, and the Adult Posture Test. The Diagnostic Analysis of Nonverbal Accuracy has established reliability and validity for children as young as 3 and adults as old as 100. The subtests of the test vary on four basic core emotions: happiness, sadness, anger, and fear, and the test provides measures of both high intensity and low intensity emotional reactions. We utilized both the Child Paralanguage and Adult Paralanguage Tests, therefore the minimum score that can be obtained is 0 and the maximum is 48. A higher score represents a positive response.|6 Weeks||||units on a scale||Standard Deviation|Mean
1252340|NCT00490802|Primary|Repetitive Behavior Scale - Revised|"The Repetitive Behavior Scale - Revised was developed to capture the breadth of repetitive behaviors that are specific to autism and is a parent report measure. In particular, it consists of 43-items that tap six repetitive behavior subtypes: Stereotyped, Self-injurious, Compulsive, Ritualistic, Sameness, and Restricted Interests.~Two scores were calculated (higher-order vs. lower-order repetitive behaviors) in an effort to decrease the number of variables analyzed. This is based on previous factor analysis that produced these two factors: higher order (ritualistic, sameness, compulsive and restricted subscales) and lower order (stereotypy and self-injury).~The higher order behaviors have 29 items that can be endorsed with a maximum score of 87 and a minimum score of 0~The lower order behaviors have 14 items that can be endorsed, with a maximum score of 42 and a minimum score of 0~In both cases, a lower score represents a positive response."|6 Weeks||||units on a scale||Standard Deviation|Mean
1252402|NCT00490451|Secondary|Overall Survival Time|Defined as the time from date of first dose to the date of death due to any cause.|First treatment dose to death due to any cause up to 26.51 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
1252341|NCT00490802|Primary|Clinical Global Impressions Scale - Improvement - Social|"The Clinical Global Impressions Scale - Improvement - Social is a well validated measure employing a 7-point scale of clinical global impression of improvement ( 1- very much improved, 2 - much improved, 3 - minimally improved, 4 - no change, 5 - minimally worse, 6 - much worse, 7 - very much worse) that the clinician fills out after considering all the available information on the participant including the parent history, the examination in clinic, reports from the school and other sources. Therefore the score is filtered through the judgment of the clinician evaluator.~The Week 6 Improvement Ratings were used to categorize patients as clinically improved (≤2) or not (>2). Sixteen of the 19 patients (84%) had data at Week 6. For the remaining three subjects, Week 6 ratings were imputed using expectation-maximization methods and the earlier Clinical Global Impression ratings. In all three cases the imputed ratings were >2 and the patients were classified as not improved."|6 Weeks||||participants|||Number
1252342|NCT00490724|Secondary|Urinary Volume|The urinary volume was measured because nesiritide has a diuretic effect. Measurement of hour urine was done in the observation period and treatment period. 1-hour urine before treatment initiation was measured in the observation period. In the treatment period, 1-hour urine for period 1 and 3-hour urine for period 2 was measured. Urinary volume was recorded for participants without urethral catheterization having spontaneous micturition when needed.|Baseline, 3 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millliter||Standard Deviation|Mean
1252343|NCT00490724|Secondary|Assessment of Dyspnea Using Respiratory Rate|Assessment of dyspnea was done by measuring respiratory rate which is the number of times an organism breathes with the lungs (respiration) per unit time, usually per minute|Baseline, 1, 2, 3, 6, 9, 15 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Breaths Per Minute (BrPM)||Standard Deviation|Mean
1252344|NCT00490724|Secondary|Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2)|Assessment of dyspnea was done by measuring SpO2 via pulse oximetry, by making the participant lye quietly in the post anesthesia care unit (PACU) and breathing room air (RA)|Baseline, 1, 2, 3, 6, 9, 12, 15 and 24 hour|The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here,n=the participants evaluated for this measure at a particular time point.|||Percentage of SpO2||Standard Deviation|Mean
1252345|NCT00490724|Secondary|Number of Participants With Oxygen Therapy|Assessment of dyspnea was done by measuring number of participants showing presence or absence of oxygen therapy.|Baseline,1 and 24 hour|The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||Participants|||Number
1252346|NCT00490724|Secondary|Number of Participants With Orthopnea|Assessment of dyspnea was done by measuring percentage of participants showing presence or absence of orthopnea (it is the sensation of breathlessness in the recumbent position, relieved by sitting or standing) symptoms|Baseline, 1 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.|||Participants|||Number
1252347|NCT00490724|Secondary|Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score|Assessment of Dyspnea was done using Likert scale. It is a 7-point scale where following scores stands for severity of dyspnea: 1=markedly better; 2=moderately better; 3=minimally better; 4=no change; 5=minimally worse; 6=moderately worse and 7= markedly worse|3, 6 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.|||Participants|||Number
1252348|NCT00490724|Secondary|Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score|Assessment of Dyspnea (difficult or labored breathing) was done using Borg scale. It is a 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight; 3=moderate; 4=somewhat severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.|Baseline, 1 h and 24 h|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.|||Participants|||Number
1252349|NCT00490724|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PVR (force that opposes the flow of blood through a vascular bed) was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. PVR was calculated by dividing (80*[MPAP−PCWP]) and CO.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||dyne*second/centimeter^5||Standard Deviation|Mean
1252350|NCT00490724|Secondary|Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour|The SVR was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. SVR was calculated by dividing (80*[MBP−MRAP]) and CO.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||dyne*second per centimeter^5||Standard Deviation|Mean
1261110|NCT00425269|Primary|Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
1252351|NCT00490724|Secondary|Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The SVI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA).|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||milliliter per meter^2||Standard Deviation|Mean
1252352|NCT00490724|Secondary|Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The SV was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. SV was calculated by dividing CO and heart rate (HR).|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||milliliter (ml)||Standard Deviation|Mean
1252353|NCT00490724|Secondary|Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The CI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. CI was calculated by dividing CO and body surface area.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Liter per minute per meter^2 (l/min/m^2)||Standard Deviation|Mean
1252354|NCT00490724|Secondary|Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour|The MBP was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. MBP was calculated as sum of diastolic blood pressure (DBP) and (0.33*[SBP−DBP])|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
1252355|NCT00490724|Secondary|Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute. Cardiac output is commonly measured by the thermodilution technique.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Liter per minute||Standard Deviation|Mean
1252356|NCT00490724|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PCWP was a measured hemodynamic parameter. It was the blood pressure, recorded after wedging a catheter in a small pulmonary artery; believed to reflect the pressure in the pulmonary capillaries. It was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
1252357|NCT00490724|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The MPAP was a measured hemodynamic parameter. MPAP was measured using a Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
1252358|NCT00490724|Secondary|Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PADP was a measured hemodynamic parameter. Normal range of PADP is 8 to 15 millimeters of mercury (mmHg). PADP was assessed by Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
1252359|NCT00490724|Secondary|Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PASP was a measured hemodynamic parameters. PASP was assessed by Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
1255990|NCT00462605|Secondary|Clinical Activity Assessed by Change in Transfusion Requirements||Baseline and after 2 cycles|Due to the limited number of clinical responders, this outcome was not measured.||||||
1252360|NCT00490724|Secondary|Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour|The MRAP was a measured hemodynamic parameter. MRAP was measured using a Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
1252361|NCT00490724|Primary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours|Change in PCWP was unmeasurable, therefore it was complemented with PADP. PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline and 3 Hours|The per protocol set (PPS) included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1252362|NCT00490698|Primary|Median Time to First Skeletal-related Event|Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.|Up to 1 year|Four participants did not experience skeletal events.|||months||95% Confidence Interval|Median
1252363|NCT00490646|Primary|Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|BOR was the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Refer to Outcome Measure 3 for definition of PD.|Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks).|All randomized participants.|||participants|||Number
1252364|NCT00490646|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.|Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.|||participants|||Number
1252365|NCT00490646|Secondary|Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0|Grade (GR)1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.|Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.|||participants|||Number
1252366|NCT00490646|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3=Severe; and Grade 4=Life-threatening or disabling. GR=Grade.|Assessed from the date of first dose until at least 30 days after the last dose of study drug (maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy.|||participants|||Number
1252367|NCT00490646|Secondary|Duration of Response|"Period measured in months from time that measurement criteria were first met for CR or PR until first date of documented PD or death from any cause without prior documentation of progression.~PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. Refer to Outcome Measure 1 for definitions of CR and PR. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by Brookmeyer and Crowley method."|From the date of first PR or CR assessment to the date of documented progressive disease or death without prior documentation of progression (maximum participant duration of response of 38 months.)|All randomized participants with CR or PR. The participants who neither relapsed nor died were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
1252403|NCT00490451|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY573636||Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle)|Participants who received study drug and had pharmacokinetic (PK) data at the specified time points.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1252446|NCT00490009|Secondary|Overall Survival (OS) Rate|Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.|6 years|1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.|||percentage of participants|||Number
1252368|NCT00490646|Secondary|Time to Response|"Time to response was defined as the time in weeks from randomization until the measurement criteria are first met for a CR or PR, whichever is recorded first.~CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method."|From randomization every 6 weeks for first 12 months and thereafter every 3 months until CR or PR whichever was recorded first (maximum participant time to response of 18.4 weeks.)|All randomized participants with CR or PR.|||weeks||Full Range|Median
1252369|NCT00490646|Secondary|Progression Free Survival (PFS)|"Time in months from randomization until first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.~Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method."|From randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression (maximum participant PFS of 39.7 months).|All randomized participants. Participants who did not progress or died were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
1252370|NCT00490646|Primary|Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)|Percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A two-sided confidence interval (CI) was computed using the Clopper-Pearson method.|Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1252371|NCT00490568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.|12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject (Full population). Only those participants available at the specified time points were analyzed.The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).|||Score on scale||Standard Deviation|Mean
1252372|NCT00490568|Secondary|Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.|DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant’s ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) * 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject (Full population). Only those participants available at the specified time points were analyzed.The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).|||Scores on scale||Standard Deviation|Mean
1252373|NCT00490568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.|The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject (Full population). Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).|||Scores on scale||Standard Deviation|Mean
1252374|NCT00490568|Secondary|Change From Baseline in Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.|The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer’s disease (AD). Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject population. Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).|||Scores on scale||Standard Deviation|Mean
1255991|NCT00462605|Secondary|Clinical Activity Assessed by Change in Peripheral Blood Counts||Baseline and after 2 cycles||||cell/mm^3||Standard Error|Mean
1252375|NCT00490568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale – Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status.|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject (Full population). Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negative, positive, homozygotes, heterozygotes).|||Scores on scale||Standard Deviation|Mean
1252376|NCT00490568|Secondary|Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT|The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported.|Up to Week 82 (including follow up)|All subject population (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1252377|NCT00490568|Secondary|Number of Participants With Hematology Parameters of PCC ATOT|The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported.|Up to Week 82 (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1252378|NCT00490568|Secondary|Number of Participants With BW Values of PCC ATOT|The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB >=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB >=7 percent. The number of participants with values of PCC including follow up were reported.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1252379|NCT00490568|Secondary|Number of Participants With HR Values of PCC ATOT|HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB >=30 and DFB >=30. The number of participants with values of PCC including follow up were reported.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1252380|NCT00490568|Secondary|Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)|The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) >=40, decrease from Baseline (DFB) >= 30 for and for DBP (IFB) >= 30 ,DFB >= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1252381|NCT00490568|Secondary|Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides|The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value.|Up to 82 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||millimole per litre (mmol/l)||Standard Deviation|Mean
1252382|NCT00490568|Secondary|Change From Baseline in Vital Sign Body Weight (BW)|BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||kg||Standard Deviation|Mean
1252383|NCT00490568|Secondary|Change From Baseline in Vital Sign Heart Rate (HR)|Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||beats per minute (bpm)||Standard Deviation|Mean
1252401|NCT00490451|Secondary|Duration of Overall Objective Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Time of response to progressive disease or death up to 15.57 months|Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.||||||
1258709|NCT00442468|Secondary|"Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness"||Day 1 of a 1-day study|All participant respondents to the questions|||participants|||Number
1252384|NCT00490568|Secondary|Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1252385|NCT00490568|Secondary|Number of Participants With Adverse Event of Oedema|Oedema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. The number of participants and their percentage for the adverse event of the various types of oedema were reported.|Up to 76 Weeks|All subject (Full population)|||Participants|||Count of Participants
1252386|NCT00490568|Secondary|Number Participants With Serious Adverse Events (SAEs) and Deaths|A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study.|Up to 76 Weeks|All subject (Full population)|||Participants|||Count of Participants
1252387|NCT00490568|Primary|Number of Participants With Any Adverse Events (AEs) and Severity of AEs|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.|Up to 76 Weeks|All Subjects (Full population), comprised of all participants who took at least one dose of open-label study medication.|||Participants|||Count of Participants
1252388|NCT00490555|Secondary|Dehydroepiandrosterone (DHEA)||10 weeks||||ng/mL||Inter-Quartile Range|Median
1252389|NCT00490555|Secondary|Androstenedione (AED)||10 weeks||||ng/mL||Inter-Quartile Range|Median
1252390|NCT00490555|Primary|Dihydrotestosterone (DHT) Concentration||10 weeks||||ng/mL||Inter-Quartile Range|Median
1252391|NCT00490555|Primary|Testosterone Concentration||10 weeks||||ng/mL||Inter-Quartile Range|Median
1252392|NCT00490555|Primary|Prostate-specific Antigen (PSA)|PSA level week 10 end of treatment|10 weeks||||ng/mL||Inter-Quartile Range|Median
1252393|NCT00490542|Primary|The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.|Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome.|Baseline to 6 weeks|Power analysis, with beta=0.20 and two-tailed alpha=0.05, was based on pilot studies for the mania registration trials which included mixed episodes and assessed MADRS scores. A projected standard error of the mean difference was assumed to be about twice as much as the mean difference (5-15 points), producing a sample size of about 100.|||Scores on a scale||95% Confidence Interval|Mean
1252394|NCT00490490|Secondary|Time-to-Progression (TTP)||2 years|One subject has not progressed (assessment not possible), and one subject has been lost to follow-up.|||Participants|||Count of Participants
1252395|NCT00490490|Secondary|Overall Response Rate (ORR)|"ORR is assessed as the sum of the overall rates of~CR confirmed by positron emission tomography (PET)~CR not confirmed by PET, and~Partial response (PR) negative for progression by PET"|12 weeks||||percentage of participants|||Number
1252396|NCT00490490|Primary|Complete Response (CR) Rate|"Participants assessed for by the following Complete Response (CR) criteria~CR or Functional CR~No evidence of disease and symptoms~Any macroscopic nodules detected in any organs no longer present.~Any palpable lymph node is normal and greatest diameter is < 1.0 cm.~The enlarged organs decreased in size and not palpable~The bone marrow biopsy and aspirate are negative for disease~Negative for disease by PET-scan (functional CR)~CR Unconfirmed (CRu) criteria~No evidence of disease and symptoms~Any lymph node mass > 1.0 cm^2 diameter has regressed is size by more than 75%.~No macroscopic nodules in any organs~Any palpable lymph node is normal and greatest diameter is < 1.0 cm.~The bone marrow biopsy and aspirate are negative for disease~The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia"|12 weeks||||percentage of participants|||Number
1252397|NCT00490477|Secondary|The Reduction of the Number of Apoptotic Cells, Stimulated With Plasma Derives From Septic Patients With Gram Negative Infection, Treated With PMX-B Hemoperfusion, on Immortalized Tubular and Glomerular Cell Cultures.||72 hours after randomization||2007-04-30|04/2007||||
1252398|NCT00490477|Primary|Number of Participants Not Requiring Renal Replacement Therapy (RRT)||28 days from the admission||||participants|||Number
1252399|NCT00490451|Secondary|Number of Participants With Adverse Events (Safety)|Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.|First treatment dose up to 26.51 months|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1252400|NCT00490451|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every other cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Time from documented SD or better to first date of progressive disease up to 15.57 months|All enrolled participants who received at least 1 dose of study drug and had a best overall response of stable disease or better.|||months||90% Confidence Interval|Median
1252404|NCT00490451|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)|Clinical Benefit Rate = (CR + PR + SD)/N as classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0), where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.|First treatment dose to measured progressive disease or death due to any cause up to 15.57 months|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
1252405|NCT00490451|Secondary|Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)|Objective response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|First treatment dose to measured progressive disease or death due to any cause up to 15.57 months|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
1252406|NCT00490451|Primary|Progression-Free Survival|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|First treatment dose to measured progressive disease or death from any cause up to 15.57 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
1252407|NCT00490269|Primary|Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.|Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.|Day 9 and 10||||participants|||Number
1252408|NCT00490256|Primary|iFAB Post-op|intestinal fatty acid binding protein level immediately postop|Immediate postop||||mcg/ml||Standard Deviation|Mean
1252409|NCT00490256|Secondary|Cerebral and Lower Body Near Infra-red Spectroscopy Measures||24 hours|||||||
1252410|NCT00490256|Primary|Intestinal Fatty Acid Binding Protein and C-reactive Protein||Baseline and 0, 3, 12, and 24 hours after surgery|||||||
1252411|NCT00490139|Secondary|DFS Ignoring Non-breast Second Primary Malignancies|Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause. DFS was estimated using the Kaplan Meier method. The non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab).|From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)|ITT Population. Participants who did not have a recurrence of the initial disease, or did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact. Non-breast second primary cancers were ignored.|||years|||Number
1252412|NCT00490139|Secondary|Time to Central Nervous System Recurrence|Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence. Both brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years.|From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a central nervous system recurrence were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis.|||years|||Number
1252413|NCT00490139|Secondary|Time to Distant Recurrence|Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence). The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years.|From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a distant recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility.|||years|||Number
1252414|NCT00490139|Secondary|Time to Recurrence|Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant). The percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years. IDMC=Independent Data Monitoring Committee.|From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis.|||years|||Number
1252447|NCT00490009|Secondary|Time to Progression (TTP)|Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.|1.5 months; 3 months; 6 months; or Not Progressed|1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.|||participants|||Number
1261111|NCT00425269|Primary|The Fasting Plasma Glucose Value, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
1252415|NCT00490139|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization until death due to any cause. Overall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.|From randomization until death due to any cause (median follow-up of 4.5 years)|ITT Population. Participants who did not die were censored at the date of last survival contact. Zero participants were analyzed in the lapatinib arm, as the Independent Data Monitoring Committee discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab).|||years|||Number
1252416|NCT00490139|Primary|Disease-free Survival (DFS)|Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause. DFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.|From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)|Intent-to-Treat (ITT) Population: all randomized par., except for those who withdrew their consent to use any of their data prior to receiving any study medication. Par. with no recurrence of the initial disease or SPC, or who did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact.|||years|||Number
1252417|NCT00490100|Primary|Change in Growth Rate on Study Drug|Growth rate on intervention is compared with growth rate before intervention for each participant.|During intervention, up to 2 years|Only participants who completed study|||cm/year||Full Range|Median
1252418|NCT00490100|Primary|Safety of Study Drug|Rates of adverse events related to study drug|1 year||||participants|||Number
1252419|NCT00490061|Secondary|Overall Survival.|Overall survival is the time from starting treatment until death due to any cause. For subjects who do not die, time to death will be censored at the time of last contact.|Two years survival rate after study enrollment|All enrolled participants.|||percentage of participants|||Number
1252420|NCT00490061|Primary|Progression Free Survival|"To determine the efficacy of combining lapatinib and radiotherapy in terms of Progression-free survival (PFS) in patients with locally advanced HNSCC who cannot tolerate concurrent chemoradiotherapy.~Progression-free survival is defined is the time from starting treatment to the time of first documented tumor progression or death due to any cause, which ever occurs first.~Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST V1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|2 year PFS: PFS at 2 yrs after study enrollment|All enrolled participants.|||percentage of participants||95% Confidence Interval|Number
1252421|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252422|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252423|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252442|NCT00490035|Secondary|Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period|"Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.~The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline."|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Percentage of Participants|||Number
1261112|NCT00425113|Secondary|Time to Sputum Culture Conversion to Negative on Solid Medium||2 months||||days||95% Confidence Interval|Median
1252424|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252425|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252426|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252427|NCT00490035|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement), with the start of the study medication as reference time point. The Investigator was to complete it by answering the following question: “Assess the Overall change in the severity of patient’s illness, compared to start of study medication.”|Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252428|NCT00490035|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject not mentally impaired had to complete it by answering the following question: “Overall, has there been a change in your seizures since the start of the study medication?”|Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252429|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
1252430|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.|||units on a scale||Standard Deviation|Mean
1252443|NCT00490035|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Seizure Frequency per Week||Inter-Quartile Range|Median
1252444|NCT00490022|Secondary|Prostate Epithelial Cell Proliferation|Prostate epithelial cell proliferation in the prostate biopsy tissue was measured using Ki-67 immunohistochemical staining of prostate epithelium as a marker of cell proliferation (values are number of Ki-67 positive stained cells per 100 prostate epithelial cells). The placebo and treatment groups were compared.|28-days||||#pos.Ki-67cells per100 prst. epth cells||Standard Deviation|Mean
1252431|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.|||units on a scale||Standard Deviation|Mean
1252432|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.|||units on a scale||Standard Deviation|Mean
1252433|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.|||units on a scale||Standard Deviation|Mean
1252434|NCT00490035|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.~Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."|||percentage of participants|||Number
1252435|NCT00490035|Secondary|Time to Tenth Type I Seizure During the 12-week Treatment Period|The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1252436|NCT00490035|Secondary|Time to Fifth Type I Seizure During the 12-week Treatment Period|The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1252437|NCT00490035|Secondary|Time to First Type I Seizure During the 12-week Treatment Period|The time to first Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1252438|NCT00490035|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period|Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Percentage of Participants|||Number
1252439|NCT00490035|Secondary|Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period|"The categories are:~<= 25 %~- 25 % to < 25 %~25 % to < 50 %~50 % to < 75 %~75 % to < 100 %~100 %"|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Percentage of Participants|||Number
1252440|NCT00490035|Secondary|Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Percent change in seizures per week||Inter-Quartile Range|Median
1252441|NCT00490035|Secondary|All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period|There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Times per week||Inter-Quartile Range|Median
1252445|NCT00490022|Primary|Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel.|After 4 weeks of either daily dihydrotestosterone transdermal gel or placebo gel, subjects underwent a prostate biopsy. Intraprostatic hormone concentrations, specifically DHT and Testosterone, were measured. Unit of measure is ng/g.|28-days||||ng/g||Standard Deviation|Mean
1252448|NCT00490009|Primary|Clinical Response Rate|Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.|6 years||||participants|||Number
1252449|NCT00489970|Secondary|Anti-PRN Antibody Concentration||9 years following vaccination||2016-06-30|06/2016||||
1252450|NCT00489970|Secondary|Anti-FHA Antibody Concentration||9 years following vaccination||2016-06-30|06/2016||||
1252451|NCT00489970|Secondary|Anti-PT Antibody Concentration||9 years following vaccination||2016-06-30|06/2016||||
1252452|NCT00489970|Secondary|Anti-T Antibody Concentration||9 years following vaccination||2016-06-30|06/2016||||
1252453|NCT00489970|Secondary|Anti-D Antibody Concentration||9 years following vaccination||2016-06-30|06/2016||||
1252454|NCT00489970|Secondary|Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||2016-06-30|06/2016||||
1252455|NCT00489970|Secondary|Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||2016-06-30|06/2016||||
1252456|NCT00489970|Secondary|Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||2016-06-30|06/2016||||
1252457|NCT00489970|Secondary|Anti-PRN Antibody Concentration|Anti-PRN antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||EL.U/mL||95% Confidence Interval|Geometric Mean
1252458|NCT00489970|Secondary|Anti-FHA Antibody Concentration|Anti-FHA antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||EL.U/mL||95% Confidence Interval|Geometric Mean
1252459|NCT00489970|Secondary|Anti-PT Antibody Concentration|Anti-PT antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||EL.U/mL||95% Confidence Interval|Geometric Mean
1252460|NCT00489970|Secondary|Anti-T Antibody Concentration|Anti-T antibody concentration is expressed as GMC in IU/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||IU/mL||95% Confidence Interval|Geometric Mean
1252461|NCT00489970|Secondary|Anti-D Antibody Concentration|Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||IU/mL||95% Confidence Interval|Geometric Mean
1252462|NCT00489970|Secondary|Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||subjects|||Number
1252463|NCT00489970|Secondary|Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||subjects|||Number
1252464|NCT00489970|Secondary|Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PT concentrations was defined as equal to or greater than 5 ELISA units per mililiter (EL.U/mL).|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||subjects|||Number
1252465|NCT00489970|Primary|Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|Anti-D cut-off was defined as greater than or equal to 0.1 international units per mililiter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA) or VERO.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||subjects|||Number
1252466|NCT00489970|Primary|Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||2016-06-30|06/2016||||
1252486|NCT00489853|Secondary|Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||kilopascal||Standard Deviation|Mean
1252467|NCT00489970|Primary|Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|Anti-T cut-off was defined as greater than or equal to 0.1 IU/mL (ELISA).|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||subjects|||Number
1252468|NCT00489970|Primary|Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||2016-06-30|06/2016||||
1252469|NCT00489918|Secondary|Percent Change in Femoral Neck BMD: Baseline to Week 24|Percent Change in Femoral Neck BMD from Baseline to Week 24|24 Weeks|ITT/Safety Population|||Percent change||Standard Deviation|Mean
1252470|NCT00489918|Secondary|Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24|Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24|24 Weeks|ITT/Safety Population|||Percent change||Standard Deviation|Mean
1252471|NCT00489918|Secondary|Absolute Change in Lumbar Spine BMD: Baseline to Week 12|Absolute Change in Lumbar Spine BMD from Baseline to Week 12|12 weeks|ITT/Safety Population|||g/cm^2||Standard Deviation|Mean
1252472|NCT00489918|Secondary|Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12|Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12|12 weeks|ITT/Safety Population|||Percent change||Standard Deviation|Mean
1252473|NCT00489918|Primary|Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24|Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24|24 weeks|Intent to treat (ITT)/Safety Population|||percent change||Standard Deviation|Mean
1252474|NCT00489866|Secondary|Beck Depression Inventory, Second Edition (BDI-II)|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6).|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.|||Units on a Scale||Standard Deviation|Mean
1252475|NCT00489866|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6).|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.|||Units on a scale||Standard Deviation|Mean
1252476|NCT00489866|Primary|Positive and Negative Symptoms Scale (PANSS)|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.|||Units on a Scale||Standard Deviation|Mean
1252477|NCT00489866|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).|Week 2 and Week 6||||Units on a Scale||Standard Deviation|Mean
1252478|NCT00489866|Primary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Week 2 and Week 6|Analysis was intention to treat.|||Units on a scale||Standard Deviation|Mean
1252479|NCT00489853|Secondary|SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score|Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data.|Single measurement taken at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
1252480|NCT00489853|Secondary|Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Kilopascals||Standard Deviation|Mean
1252481|NCT00489853|Secondary|Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252482|NCT00489853|Secondary|Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252483|NCT00489853|Secondary|Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252484|NCT00489853|Secondary|Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252485|NCT00489853|Secondary|Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252487|NCT00489853|Secondary|Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liter||Standard Deviation|Mean
1252488|NCT00489853|Secondary|Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252489|NCT00489853|Secondary|Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Median
1252490|NCT00489853|Secondary|Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252491|NCT00489853|Secondary|Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252492|NCT00489853|Secondary|Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
1252493|NCT00489853|Secondary|Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liter||Standard Deviation|Mean
1252494|NCT00489853|Secondary|Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). All patients with data are included.|Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
1252495|NCT00489853|Secondary|Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).|Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
1252496|NCT00489853|Secondary|Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).|Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
1252497|NCT00489853|Secondary|Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose|The Borg CR10 Scale consists of 10-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness. Patients are allowed to assign an even higher number depending on their perceived level of breathlessness).|Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
1252498|NCT00489853|Secondary|Number of Inhalations of Reliever Medication|The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Number of inhalations during 24 hours||Standard Deviation|Mean
1252499|NCT00489853|Secondary|Cough Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of coughing) to 4 (never free of need to cough).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
1252500|NCT00489853|Secondary|Chest Tightness Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any discomfort) to 4 (almost constant discomfort).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Score on a scale||Standard Deviation|Mean
1252501|NCT00489853|Secondary|Breathlessness Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any difficulty in breathing) to 4 (almost constant difficulties in breathing). All patients with data from both periods are included.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Score on Scale||Standard Deviation|Mean
1252502|NCT00489853|Secondary|Sleep Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (symptoms did not cause a sleep problem) to 4 (did not sleep at all due to symptoms).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Score on Scale||Standard Deviation|Mean
1252503|NCT00489853|Secondary|Peak Expiratory Flow (PEF) Before Morning Dose|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Liters/minute||Standard Deviation|Mean
1252504|NCT00489853|Secondary|Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment||||Liters||Standard Deviation|Mean
1261693|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥2 to <12 Years||Day 21||||ug/mL||Full Range|Mean
1252505|NCT00489853|Secondary|Forced Vital Capacity (FVC) Pre-dose|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment||||Liters||Standard Deviation|Mean
1252506|NCT00489853|Secondary|Forced Expiratory Flow (FEV1) Pre-dose|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment||||Liters||Standard Deviation|Mean
1252507|NCT00489853|Secondary|Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose|Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.|Single measurement taken 6 hours post-dose at the end of each 1-week treatment period||||Seconds||Standard Deviation|Mean
1252508|NCT00489853|Primary|Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose|Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.|Single measurement taken1 hour post-dose at the end of each 1-week treatment period||||Seconds||Standard Deviation|Mean
1252509|NCT00489736|Other Pre-specified|Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting|"The considered event is the occurrence of the MSE excluding gastrointestinal specific treatment emergent events defined as diarrhoea, nausea, vomiting. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.|||participants|||Number
1252510|NCT00489736|Secondary|Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event|"The considered event is the occurrence of the MSE defined as thyroid, hepatic, pulmonary, neurological, skin, eye, or gastrointestinal specific treatment emergent events or premature study drug discontinuation following any adverse event (AE), whichever comes first. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.|||participants|||Number
1252511|NCT00489736|Primary|Treatment Failure|"The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the efficacy analysis according to the treatment received.|||participants|||Number
1252512|NCT00489554|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 5|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1252513|NCT00489554|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1252514|NCT00489554|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 fever was axillary temperature > 39.5°C. Grade 3 drowsiness, irritability, and loss of appetite was general symptom which prevented normal everyday activities. Grade 3 diarrhea was ≥ 6 looser than normal stools/day and Grade 3 vomiting was ≥ 3 episodes of vomiting/day. Related was solicited general symptom considered by the investigator to have a causal relationship to study vaccination.|Within 4 days following any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1252515|NCT00489554|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of grade and whatever the number of injections.|Within 4 days following any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1252516|NCT00489554|Secondary|Number of Subjects Seropositive for Anti-Protein D Antibodies|Seropositivity was defined as antibody concentration greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
1252517|NCT00489554|Secondary|Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody opsonic titer greater than or equal to 8. The vaccine pneumococcal cross-reactive serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
1257464|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 24|Value at Week 24 minus value at baseline.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1252518|NCT00489554|Secondary|Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
1252519|NCT00489554|Secondary|Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes|Seropositivity was defined as an opsonic titer greater than or equal to 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
1252520|NCT00489554|Secondary|Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
1252521|NCT00489554|Secondary|Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes|The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1252522|NCT00489554|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes|Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||microgram per milliliter||95% Confidence Interval|Geometric Mean
1252523|NCT00489554|Secondary|Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter|The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
1252524|NCT00489554|Secondary|Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes|The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1252525|NCT00489554|Primary|Antibody Concentrations Against Protein D|Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||ELISA units per milliliter||95% Confidence Interval|Geometric Mean
1252526|NCT00489554|Primary|Antibody Concentrations Against Pneumococcal Vaccine Serotypes|Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||microgram per milliliter||95% Confidence Interval|Geometric Mean
1252527|NCT00489541|Secondary|Number of Participants With Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.|The number of participants who experience a TLF through 365 days post-procedure out of the patients who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.|12 months post-index procedure|Intent-to-Treat. All enrolled patients are included in the analysis.|||participants|||Number
1252528|NCT00489541|Primary|In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)|Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.|9 months post-index procedure|The primary analysis population for the superiority testing of the primary endpoint, 9-month in-stent late loss, is the intent-to-treat (ITT) population, i.e. all patients who had a study device implanted at the target lesion and completed their angiographic follow-up.|||millimeter||Standard Deviation|Mean
1252529|NCT00489489|Secondary|Pharmacokinetic [PK]: Teriflunomide Plasma Concentration|Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.|24 weeks|All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.|||micrograms/mililiter (μg/mL)||Standard Deviation|Mean
1252542|NCT00489424|Secondary|Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.|A major increase (worsening) in severity was defined as an increase in severity of 2 units or more from baseline at least once during the 3 days immediately following i.v. infusion of zoledronic acid 5 mg. The severity of the symptom was evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).|0 - 3 days|Intent to Treat (ITT) population.|||proportion of patients|||Number
1257465|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 104|Value at Week 104 minus value at baseline.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1252530|NCT00489489|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and IFN-β dose level as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||relapses per year||95% Confidence Interval|Number
1252531|NCT00489489|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN;"|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1252532|NCT00489489|Secondary|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters per scan|||Number
1252533|NCT00489489|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||lesions per scan||95% Confidence Interval|Number
1252534|NCT00489489|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume of all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors)."|baseline (before randomization) and 24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters||Standard Error|Least Squares Mean
1252535|NCT00489489|Primary|Overview of AE With Potential Risk of Occurrence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly Hair loss and Hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1252536|NCT00489489|Primary|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1252537|NCT00489476|Other Pre-specified|Responders, Sustained Freedom From Pain|The percentages of patients with sustained freedom from pain (pain-free at 2 hours after dosing with no rescue medication and no recurrence of headache from 2 to 24 hours)|Baseline through 24 h post-dose|ITT with LOCF Population|||Participants|||Count of Participants
1252538|NCT00489476|Secondary|Pain-free at 2 Hours|Pain-free (Pain-IHS) at the 2 hour time point|Baseline and 2 h post-dose|ITT with LOCF Population|||Participants|||Count of Participants
1252539|NCT00489476|Primary|Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours|"The primary efficacy endpoint was Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD.~Intent to treat (ITT) with last observation carried forward (LOCF)"|Baseline and 2 h post-dose|ITT Population with LOCF|||participants|||Number
1252540|NCT00489424|Secondary|Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity|Effect on severity of symptoms following i.v. infusion of zoledronic acid 5 mg. The VAS is a 100-mm linear visual analog scale (0 = no symptoms to 100 = severe symptoms). The baseline VAS measurement was defined as the VAS measurement recorded prior to the infusion.|0 - 3 days|Intent to Treat (ITT) population. Number of participants analyzed may vary from ITT population due to some patients not reporting baseline or post baseline VAS measurement. Calculating change requires both baseline and post baseline values to be present.|||units on a scale||Standard Deviation|Mean
1252541|NCT00489424|Secondary|Proportion of Patients Reporting Severe Questionnaire Symptoms.|A severe questionnaire symptom was defined as experiencing a severe specified symptom (feeling feverish, experiencing headaches, having aches and pains of muscles and joints) at least once post-baseline.|0 - 3 days|Intent to Treat (ITT) population.|||proportion of patients|||Number
1261694|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years||Day 21||||ug/mL||Full Range|Mean
1252543|NCT00489424|Secondary|Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.|Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Number of patients who took rescue medication at least once. Two patients who took rescue medication in fluvastatin arm were not included in analysis since the time rescue medication was taken was not recorded.|||hours||Standard Deviation|Mean
1252544|NCT00489424|Secondary|Number of Rescue Medication Tablets Taken|Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Number of patients who took rescue medication at least once. One patient in acetaminophen arm was not included in analysis since the number of tablets taken was not recorded.|||tablets||Standard Deviation|Mean
1252545|NCT00489424|Secondary|Proportion of Patients Who Used Rescue Medication.|Patients that took rescue medication >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Intent to Treat (ITT) population. One patient who used rescue medication in acetaminophen arm and two patients in fluvastatin arm were not included in analysis due to lack of documentation regarding use and exposure of rescue medication.|||proportion of patients|||Number
1252546|NCT00489424|Secondary|Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.|Clinically significant increase in oral body temperature >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.|0 - 3 days|Intent to Treat (ITT) population.|||proportion of patients|||Number
1252547|NCT00489424|Primary|Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.|Clinically significant increase in oral body temperature or used rescue medication ibuprofen >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.|0 - 3 days|Intent to Treat (ITT) population.|||proportion of patients|||Number
1252548|NCT00489411|Secondary|Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item|Change in average pain from Week 8 to Week 12, measured on day 1 of Weeks 8 and 13 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 8 minus value at Day 1 of Week 13 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the crossover treatment period.|Day 1 of Week 8 to Day 1 of Week 13|Patients who completed crossover intervention and had complete data were included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1252549|NCT00489411|Secondary|Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5|Patient-reported QOL was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) subscale on day 1 of weeks 1, 6, 8, and 13. The instrument contains 11 questions, assessing numbness, tingling, and discomfort in the hands or feet; difficulty hearing; tinnitus; joint pain or muscle cramps; weakness; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0 to 4 (o, not at all; 4, very much) and summed (total score range, 0-44, with higher scores indicating a worse outcome). A 2- to 3-point change is defined as a clinically meaningful improvement in QOL per published recommendations specific to similar measures. The Mean Change During Initial Treatment Period in the FACT/GOG-Ntx total score are reported for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.|Day 1 of Week 1 to Day 1 of Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.|||units on a scale||95% Confidence Interval|Mean
1252550|NCT00489411|Secondary|Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score|Change in pain-related functional interference score during the initial treatment period (Week 1 to Week 5), as measured by the BPI-SF interference score: Using an accepted method for accessing the influence of pain on function, 7 BPI-SF items were used to quantify the degree to which pain interfered with daily activities or function (0, does not interfere; 10 completely interferes). The 7 items were summed to obtain a total interference score, which ranged from 0 to 70, with lower scores meaning less interference. The mean change in pain-related functional interference score during the initial treatment period are reported below for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.|Day 1 of Week 1 to Day 1 to Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.|||units on a scale||95% Confidence Interval|Mean
1252570|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1261695|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years||Day 21||||ug/mL||Standard Deviation|Mean
1252551|NCT00489411|Primary|Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item|Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach’s alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period.|Day 1 of Week 1 to Day 1 of Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.|||units on a scale||95% Confidence Interval|Mean
1252552|NCT00489359|Secondary|Phase 2 - Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.|baseline to measured progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||Months||95% Confidence Interval|Median
1252553|NCT00489359|Secondary|Phase 2 - Number of Participants With Adverse Events (Toxicity)|A listing of adverse events is located in the Reported Adverse Event module.|baseline through end of Phase 2 (up to 31 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||participants|||Number
1252554|NCT00489359|Secondary|Phase 2 - Overall Survival|Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. This analysis was not done due to the high number of censored patients.|baseline to date of death from any cause (up to 31 months)|Protocol Qualified (PQ) population. This analysis was not done due to the high number of censored patients.|||months||95% Confidence Interval|Median
1252555|NCT00489359|Secondary|Phase 2 - Time to Treatment Failure|Time to treatment failure (TTTF) is defined as the time from the date of study enrollment to the date of the first observation of disease progression, death from any cause, or early discontinuation of treatment (any reason). For patients who are alive, progression-free, and have not discontinued early at the time of analysis, TTTF will be censored at the date of the last objective progression-free disease assessment.|First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||Months||95% Confidence Interval|Median
1252556|NCT00489359|Secondary|Phase 2 - Time to Disease Progression|Time to objective progressive disease (TTPD) is defined as the time from the date of study enrollment to the date of objectively determined Progressive Disease (PD). For patients who die without objective PD (including death from study disease), TTPD will be censored at the date of the last objective progression-free disease assessment. For patients who are still alive at the time of analysis, and who do not have PD, TTPD will be censored at the date of the last objective progression-free disease assessment.|baseline to measured progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined using RECIST."|||Months||95% Confidence Interval|Median
1252557|NCT00489359|Secondary|Phase 2 - Duration of Response (DOR)|Duration of response is defined as the time from first observation of Complete Response or Partial Response to the first observation of Progressive Disease or death from any cause. For patients who are still alive at the time of analysis, and who do not have Progressive Disease, duration of response will be censored at the date of the last objective progression-free disease assessment.|time of response to progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||Months||95% Confidence Interval|Median
1252558|NCT00489359|Secondary|Phase 2 - Time to Response (TTR)|Response is defined as CR (Complete Response) or PR (Partial Response) per RECIST criteria. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|First treatment to response (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||Months||95% Confidence Interval|Median
1252571|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 84 (Visit 5)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1261696|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years||Day 21||||ug/mL||Standard Deviation|Mean
1252559|NCT00489359|Secondary|Phase 1 - Number of Participants With Tumor Response|Patients were analyzed by Cancer Antigen-125 (CA-125) response criteria and RECIST guidelines. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||Participants|||Number
1252560|NCT00489359|Secondary|Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2|MTD was to be used as Phase 2 recommended dose. MTD determined by increasing doses up to AUC 6 mg/mL*min based on pattern of DLT (Outcome #3). If none of 3 initial participants at given level had DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had DLT in Cycle 1 at dose level, that dose level was considered MTD. However, based on results from Phase 2 Study (NCT00109096), further dose escalations were not explored: carboplatin dose was selected based on standard dose employed in control arm of first-line therapy for epithelial ovarian cancer (Bookman 2006).|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||mg/mL*min|||Number
1252561|NCT00489359|Secondary|Phase 1 - Recommended Dose of Pemetrexed for Phase 2|MTD was to be used as Phase 2 recommended dose. MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 based on observed pattern of dose limiting toxicity (DLT: See Outcome #3). If none of 3 initial participants at a given level had a DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from another Phase 2 Study (NCT00109096), further dose escalations were not explored and dose was selected based on results of that Phase 2 Study.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||mg/m^2 (milligrams per square meter)|||Number
1252562|NCT00489359|Secondary|Phase 1 - Number of Participants With Adverse Events (Toxicity)|A listing of adverse events is located in the Reported Adverse Event module.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||Participants|||Number
1252563|NCT00489359|Secondary|Phase 1 - Number of Dose-Limiting Toxicities (DLTs)|"The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L).~Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE Grade 3 alanine transaminase (ALT) or aspartate aminotransferase (AST) that returned to baseline prior to next treatment).~Treatment delay more than 1 week due to toxicity."|baseline through end of Phase 1 (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||DLT events|||Number
1252564|NCT00489359|Primary|Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)|"Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions.~Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)*100"|baseline to measured progressive disease (PD) (up to 18 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||percentage of participants||95% Confidence Interval|Number
1252565|NCT00489359|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin|MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.|First treatment to toxicity (up to 18 months)|MTD was not determined in this study, so zero participants were analyzed.|||mg/m^2|||Number
1252566|NCT00489268|Secondary|Percentage of Participants With Sub-squamous Intestinal Metaplasia|The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.|5 year|The analysis was done per protocol.|||Percent of Participants|||Number
1252567|NCT00489268|Secondary|Adverse Events|The secondary outcome adverse events was defined as any event that occurred during the course of the trial|5 year|The analysis was done per protocol.|||Participants|||Number
1252568|NCT00489268|Secondary|Progression of Histological Grade|Secondary outcomes of progression of histological grade was defined as proportion of participants who had progression of disease such as (i) prevalence of dysplasia; (ii) Kaplan-Meier CR-IM (Complete Response to Intestinal Metaplasia) survival analysis.|5 year|The analysis was done per protocol.|||Percent of Participants|||Number
1252569|NCT00489268|Primary|Percentage of Participants With Histological Clearance of Barrett's Metaplasia|The primary study outcomes were defined as the percent of patients with complete histological response to intestinal metaplasia (IM) (CR-IM). CR-IM means complete eradication of IM (diseased epithelium). A patient was considered a Complete Responder (CR) if all biopsies (100%) were negative for intestinal metaplasia (CR-IM).|5 year|The analysis was done per protocol.|||Percent of Participants|||Number
1275994|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||270 days||||Percentage of participants|||Number
1252572|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1252573|NCT00489255|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1252574|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1252575|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1252576|NCT00489255|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1252577|NCT00489255|Secondary|Median Time to 'on' for Visit 5/End of Period 3 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 84 (Visit 5)||||minutes||95% Confidence Interval|Median
1252578|NCT00489255|Secondary|Median Time to 'on' for Visit 4/End of Period 2 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 56 (Visit 4)||||minutes||95% Confidence Interval|Median
1252579|NCT00489255|Secondary|Median Time to 'on' for Visit 3/End of Period 1 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Median
1252580|NCT00489255|Secondary|Median Time to 'on' for Visit 2/Period 1 Injection 2|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Median
1252581|NCT00489255|Secondary|Median Time to 'on' for Visit 2/Period 1 Injection 1|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Median
1252582|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 3|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 84 (Visit 5)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.|||participants|||Number
1252583|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 2|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.|||participants|||Number
1252584|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 1|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 28 (Visit 3)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.|||participants|||Number
1252585|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 57-84|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1261697|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years||Day 21||||ug/mL||Standard Deviation|Mean
1252586|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 29-56|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1252587|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 1-28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1252588|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 3||Days 57-84|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||participants|||Number
1252589|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 2||Days 29-56|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||participants|||Number
1252590|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 1||Days 1-28|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||participants|||Number
1252591|NCT00489255|Primary|Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1||Day 1 (Period 1, Visit 2)|Primary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||participants|||Number
1252592|NCT00489216|Secondary|Overall Hepatic Response Rate|The normalization of the total serum bilirubin to <2mg/dL|On study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab|There is no data for this outcome measure as no enrolled patients had an elevated bilirubin level.||||||
1252593|NCT00489216|Secondary|Complete Cutaneous Response Rate|The complete disappearance of all signs of cutaneous graft-versus-host disease. Complete cutaneous response rate + partial cutaneous response rate|On study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab||||participants|||Number
1252594|NCT00489216|Secondary|Overall Complete Response Rate|To assess the overall complete response rate on study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab. A complete response (CR) was defined as the total resolution of skin disease, and a partial response was defined as >=50% reduction in the proportion of total body surface area involved by rash.|57 days|Of the two patients, one patient completed all 8 doses of study medication according to schedule. The other patient received 6/8 scheduled efalizumab doses, but was subsequently taken off the study after developing transient coagulase negative staphylococcal bacteremia. The patient demonstrated a complete response (CR).|||Participants|||Count of Participants
1252595|NCT00489216|Primary|Exploratory Assessment of the Staining of Cutaneous Tissues for LFA-1, ICAM-1, CD4, CD8, and Possibly CD20|Numerical scoring system for both LFA-1 and ICAM-1 expression which could then be used in a larger phase II trial to correlate clinical response rates to pathological findings.|57 days|There is no data for this outcome measure because of the small number of patients and inability to make meaningful conclusions||||||
1252596|NCT00489216|Primary|Degree of Skin Involvement by GVHD Using Two Digital Photography Techniques.|"Estimate of the percentage of body surface area involved by GVHD using two digital photography techniques and computerized image analyses:~Digital photography and body surface area calculations: A total of 12 digital photographs were obtained from different body regions using systematic digital imaging and computerized image analysis.~Body surface area calculations: Using National Institutes of Health image software, each body region will be manually traced and the total area of the traced area determined. Using a similar technique, each part of the region that is involved by a GVHD rash will also be traced and its area measured. The areas involved by rash will then be summed, and finally divided by the total area of the region. In so doing, the percentage of each region that is involved by GVHD will be determined."|120 days|Data was not collected for this objective due to limited number of participants. A minimum of 12 patients were needed for analysis.||||||
1252597|NCT00489216|Primary|Number of Subjects Experiencing Adverse Events|"The primary objective of this exploratory study is to evaluate the general tolerability of efalizumab in patients suffering from steroid refractory GVHD~Subjects will be evaluated for drug toxicity each visit. Toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) common criteria."|120 days|Of the two patients, one patient completed all 8 doses of study medication according to schedule. The other patient received 6/8 scheduled efalizumab doses, but was subsequently taken off the study after developing transient coagulase negative staphylococcal bacteremia.|||participants|||Number
1252598|NCT00489086|Secondary|Overall Response at Treated Lesions||36 months|||||||
1252599|NCT00489086|Secondary|Estimated Duration of Complete Response||36 months|||||||
1252600|NCT00489086|Secondary|Time to Progression||36 months|||||||
1252601|NCT00489086|Secondary|Time to Lesion Clearance||36 months|||||||
1252602|NCT00489086|Primary|Complete Response Rate|The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient’s “target” lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.|36 months|Intention to treat|||participants|||Number
1252603|NCT00488865|Primary|Percentage of Participants With Retrieval Clinical Success|Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.|upto 175 days|The population for Option filter retrieval was based on intention to treat (ITT). Retrieval procedures were attempted in 39 of the 100 enrolled patients.|||Percent of Participants||95% Confidence Interval|Number
1257466|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 52|Value at Week 52 minus value at baseline.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1252604|NCT00488865|Secondary|Placement Technical Success|Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.|Immediately post placement procedure||||Percent of Participants||95% Confidence Interval|Number
1252605|NCT00488865|Primary|Percentage of Participants With Clinical Success|Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.|up to 180 days|The number of participants was determined per intention to treat (ITT).|||Percent of Participants||95% Confidence Interval|Number
1252606|NCT00488826|Secondary|Concentration of Serotype-Specific IgG Antibodies|Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study and as 0.35 ug/ml by the World Health Organization (WHO).|7 months|"The population analyzed was all the available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post third dose serum available for assessment) and were in either 7vPnC+DTaP Concurrently or DTaP Alone group. The 7vPnC Separately group was not included as part of this objective."|||ug/ml||95% Confidence Interval|Geometric Mean
1252607|NCT00488826|Primary|Concentration of Serotype-Specific IgG Antibodies|Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study, and as 0.35 ug/ml by the World Health Organization (WHO).|7 months|"Population analyzed was available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post-third dose serum available for assessment) and were in either the 7vPnC separately or DTaP alone group. The 7vPnC + DTaP group was not part of the primary objective; no statistical testing was done."|||ug/ml||95% Confidence Interval|Geometric Mean
1252608|NCT00488774|Secondary|Number of Participants With Clinical Remission|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here ‘N’ signifies participants who were evaluated for this outcome measure.|||Participants|||Number
1252609|NCT00488774|Primary|Number of Participants With Clinical Response|Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here ‘N’ signifies participants who were evaluated for this outcome measure.|||Participants|||Number
1252610|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination|To assess the kinetics of serogroup A, C, W-135 and Y specific IgG concentrations, the geometric mean concentration was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.|Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.|||µg/mL||95% Confidence Interval|Geometric Mean
1252611|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Serogroup A, C, W-135 and Y specific IgG concentrations were measured before and one month after MenACWY-CRM booster vaccination by ELISA.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.|||µg/mL||95% Confidence Interval|Mean
1252612|NCT00488683|Secondary|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age|Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccination at 12 months of age.|7 days post 12 months vaccination|The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age).|||Percentage of subjects|||Number
1252613|NCT00488683|Secondary|Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age|Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccinations at 12 months of age.|7 days post 12 month vaccination|The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age).|||Percentage of subjects|||Number
1252614|NCT00488683|Secondary|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations|Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM (2 and 4 months) and routine infant primary vaccinations (2, 3 and 4 months).|7 days post vaccination at 2, 3, and 4 months of age|The analysis was performed on the safety population.|||Percentage of subjects|||Number
1252615|NCT00488683|Secondary|Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.|Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after each MenACWY-CRM and routine infant vaccination administered as a primary course of vaccination.|7 days post each MenACWY-CRM and routine infant vaccination|The analysis was performed on the Safety Population.|||Percentage of subjects|||Number
1252616|NCT00488683|Secondary|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months|"The rise in serogroup-specific hSBA and IgG was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x) at 12 months where x is the serogroup specific IgG or SBA titers.~Linear regression analysis between memory B cells at 5 months of age and rise in hSBA titers or IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model."|1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)|Analysis was performed on the PP dataset after booster vaccination.||||||Number
1252617|NCT00488683|Secondary|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM|Linear regression analysis between memory B cells at 5 months of age and hSBA titers and IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model.|1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)|Analysis was performed on the PP dataset of persistence population.||||||Number
1252618|NCT00488683|Secondary|Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants|The serogroup A, C, W-135 and Y specific IgG concentrations were measured in the serum of mothers at the time of their enrollment into the study (Day 1) by ELISA.|Day 1 (IgG) and one month after primary vaccination (B cells)|Analysis was performed on the PP primary population.||||||Number
1252619|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific hSBA Titers After MenACWY-CRM Primary Vaccination|To assess the kinetics of serogroup A, C, W-135 and Y specific hSBA titers, the geometric mean titer was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.|Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.|||titers||95% Confidence Interval|Geometric Mean
1252620|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination|"To assess the kinetics of serogroup A, C, W-135 and Y specific memory B cells, plasma B cells and IgG concentrations were measured on days 0, 7, 14, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.~The memory B cell response at different timepoint was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators in vitro.~The B plasma cell response at each time point was defined as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC."|Day 0, 7, 14, 49, 90, and 120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.|||per 2x100000 cells||Standard Deviation|Mean
1252621|NCT00488683|Secondary|Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination|The memory B cell response in children lacking a hSBA titer ≥1:8 one month after MenACWY-CRM primary vaccination was calculated as the mean number of meningococcal serogroup specific memory B cells, measured by ELISpot assay per 2x100000 LOC.|One month after primary vaccination|Analysis was performed on the PP primary population and PP persistence population, subjects lacking hSBA ≥1:8 one month after primary vaccination.|||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
1252622|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|hSBA GMTs were measured before and one month after MenACWY-CRM booster vaccination at 12 months of age.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.|||titers||95% Confidence Interval|Mean
1252623|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Memory B cell response before and one month after MenACWY-CRM booster vaccination at 12 months of age was measured as mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells by ELISpot assay per 2x100000 LOC.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.|||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
1252624|NCT00488683|Secondary|CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination|"CRM197 specific memory B cell response at each time point was measured as mean number of CRM197 specific memory B cells by ELISpot assay per 2x100000 LOC.~CRM197 specific IgG concentration was measured by ELISA at 12 months of age and one month after MenACWY-CRM booster vaccination."|5 months (B cells), 12 months and 13 months (B cells and IgG) of age|Analysis was done on the PP primary population and PP booster population.||||||Number
1252625|NCT00488683|Secondary|Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y|"Memory B cell response at 1 month after primary vaccination and at 1 week after third vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~Plasma B cell response at 1 week after vaccination was measured as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC.~Serogroup A, C, W-135 and Y specific IgG were measured by ELISA and hSBA GMTs were measured at 1 week after third vaccination."|One month after primary vaccination and 1 week after third vaccination|This outcome was assessed in Group 3 subjects only as they provided a blood draw at 1 week following the MenACWY-CRM booster vaccination. Analysis was performed on PP booster population.||||||Number
1265979|NCT00391599|Primary|Number of Participants With Bowel Sounds|bowel sounds: present|On postoperative day 1||||participants|||Number
1252626|NCT00488683|Secondary|Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination|"Memory B cell response at 1 month after MenACWY-CRM primary and third (booster) vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~The serogroup A, C, W-135 and Y specific IgG concentrations at 1 month after MenACWY-CRM booster were measured by ELISA.~hSBA GMTs were measured by hSBA assay one month after MenACWY-CRM booster vaccination.~The rise in serogroup specific IgG, memory B cells and hSBA was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x)at 12 months where x is the serogroup specific IgG or memory B cell concentrations or SBA titers."|1 month after primary and pre-third and 1 month after third vaccination|"Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months.~Analysis was performed on PP booster population."||||||Number
1252627|NCT00488683|Secondary|Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination|"Memory B cell response at 1 month after MenACWY-CRM primary and booster vaccinations was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~hSBA GMTs for the serogroup A, C, W-135 and Y were measured one month after the third MenACWY-CRM vaccination.~The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations one month after third MenACWY-CRM vaccination were measured by ELISA."|1 month after primary vaccination and 1 month after third vaccination|"Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months.~Analysis was performed on PP booster population."||||||Number
1252628|NCT00488683|Secondary|Memory B Cells by Serogroup A, C, W-135 and Y|"Memory B cell response at 1 month after primary vaccination and immediately before third dose at 12 months of age was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations immediately before third dose at 12 months of age were measured by ELISA."|1 month after primary vaccination and immediately before third dose|Analysis was performed on PP dataset of persistence population.||||||Number
1252629|NCT00488683|Primary|Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y|"The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators.~Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose).~Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y."|1 month after primary vaccination and immediately before third dose at 12 months of age|Analysis was performed on per-protocol (PP) dataset of primary vaccination, i.e. subjects who received all the relevant doses of vaccine correctly; provided evaluable blood samples at the relevant time points; and had no major protocol violation as defined prior to analysis.|||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
1252630|NCT00488644|Primary|Number of Participants Demonstrating Improvement With Impaired Neuro-cognitive Function (NCF) Based on Results of a Series Neuro-cognitive Exams Administered at Baseline and 8 Weeks After Liothyronine Therapy|At baseline, each participant's scores for standardized/widely-used NCF exams are recorded (recalled words/objects/sequence repetition/etc per tests listed below). After 8 weeks liothyronine therapy, participants are tested again and scores compared to baseline scores. If the participant recalls more numbers/objects/sequence repetition faster/etc., than previous scores, this constitutes an improvement in NCF function for that individual. Scores are not compared to other participants. NCF tests: Memory by RAVLT (Rey Auditory Verbal Learning Test), scored by the number of words correctly recalled at different timepoints; Attention by Digit Span Exam (accurately repeating a sequence of numbers just spoken); Processing speed by Digit Symbol Exam (accurately matching numbers with associated symbols) Executive function by Trail Making Tests and Controlled Oral Word Association; Motor dexterity evaluated by correctly placing pegs in pegboards in a specified time.|At baseline and after 8 weeks of treatment||||participants|||Number
1252631|NCT00488631|Secondary|Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 54|Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1252632|NCT00488631|Secondary|Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1253096|NCT00485953|Secondary|BMD by DXA at the Femoral Neck and Total Hip|BMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan.|at 24 months||||percentage change||Standard Error|Mean
1275995|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||180 days||||Percentage of participants|||Number
1252633|NCT00488631|Secondary|Number of Participants With Mucosal Healing at Both Week 30 and Week 54|Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1252634|NCT00488631|Secondary|Number of Participants With Clinical Remission at Both Week 30 and Week 54|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1252635|NCT00488631|Primary|Number of Participants in Clinical Response Through Week 54|Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician’s global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.|Induction Baseline, Week 0 through Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1252636|NCT00488618|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator’s assessment of overall severity of the participant’s illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate.|Baseline, 3 Weeks|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment, LOCF.|||score on a scale||Standard Error|Least Squares Mean
1252637|NCT00488618|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant’s perception of his or her condition over the previous 48 hours, as well as the physician’s clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate.|Baseline, Week 3|Intent-to-treat Population included Participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment, last observation carried forward (LOCF).|||score on a scale||Standard Error|Least Squares Mean
1252638|NCT00488592|Secondary|Clinical Response|Hematological response status|16 weeks|||||||
1252639|NCT00488592|Primary|Efficacy in Inducing or Boosting a Cellular Immune Response|A T-cell response was considered positive if the frequencies of interferon (IFN-γ+) cluster of differentiation (CD8+) T cells in peptide-stimulated peripheral bloody mono-nucleated cells (PBMCs) were 2-fold or more higher than the frequencies of interferon (IFN-γ+) CD8+ T cells in unstimulated PBMCs and if there was a minimum of 0.05% Interferon (IFNγ+) CD8+ T cells (after subtracting the frequencies of interferon (IFNγ+) CD8+ T cells in unstimulated PBMCs). A significant vaccine-induced CD8+ T-cell response was defined as the emergence of detectable PR1 or WT1-specific CD8+ T cells when the pre-study analysis found no response, or a 2-fold increase in frequencies when responses were present before vaccination.|16 weeks||||participants|||Number
1252640|NCT00488514|Secondary|Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire–Revised (PPMQ-R) at Month 12|The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from “very satisfied” (1) to “very dissatisfied” (7).|End of Study/Month 12|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.|||participants|||Number
1252662|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Race|"The number of participants with any adverse event was categorized by race. The category Other captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White."|Baseline through End of Study (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet|||participants|||Number
1253097|NCT00485953|Primary|BMD of Spine by DXA|BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.|at 24 months||||percentage change||Standard Error|Mean
1252641|NCT00488514|Secondary|Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire–Revised (PPMQ-R) at the Screening Visit|The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from “very satisfied” (1) to “very dissatisfied” (7).|Screening|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.|||participants|||Number
1252642|NCT00488514|Secondary|Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12|The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status.|Baseline and Months 3, 6, 9, and 12|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.|||points on a scale||Standard Error|Mean
1252643|NCT00488514|Secondary|Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting|The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||treated migraine attacks|||Number
1252644|NCT00488514|Secondary|Number of Migraine Attacks Rated With the Indicated Pain Severity|The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||treated migraine attacks|||Number
1252645|NCT00488514|Secondary|Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet|The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||migraine attacks|||Number
1252646|NCT00488514|Secondary|Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month|The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||events||Standard Deviation|Mean
1252647|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment|||treated migraine attacks|||Number
1252648|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment|||treated migraine attacks|||Number
1252649|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment|||treated migraine attacks|||Number
1252650|NCT00488514|Secondary|Number of Treated Migraine Attacks|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John’s Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet.|Baseline through End of Study (up to Month 12)|Intent-to-Treat (ITT) Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment|||treated migraine attacks|||Number
1252651|NCT00488514|Secondary|Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator|The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator.|Screening and Final Visit (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||participants|||Number
1252652|NCT00488514|Secondary|Mean Heart Rate for All Study Participants at the Indicated Time Points|A sitting heart rate was measured once for each participant at each visit.|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||beats per minute||Standard Deviation|Mean
1252653|NCT00488514|Secondary|Mean Blood Pressure for All Study Participants at the Indicated Time Points|At each visit, a participant’s blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure.|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1252654|NCT00488514|Secondary|Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points|BMI = (Weight in kilograms)/(height in centimeters/100)^2|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||kilograms per meters squared||Standard Deviation|Mean
1252655|NCT00488514|Secondary|Mean Weight for All Study Participants at the Indicated Time Points||Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||kilograms||Standard Deviation|Mean
1252656|NCT00488514|Secondary|Mean Height for All Study Participants at the Indicated Time Points||Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary by visit, depending on the number of assessments completed at each visit.|||centimeters||Standard Deviation|Mean
1252657|NCT00488514|Secondary|Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit|A shift from “normal to low,” for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||participants|||Number
1252658|NCT00488514|Secondary|Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit|A shift from “normal to low,” for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL).|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||participants|||Number
1252659|NCT00488514|Secondary|Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet|The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||tablets|||Number
1252660|NCT00488514|Secondary|Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet|The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
1252661|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Gender|The number of participants with adverse events by gender is recorded.|Baseline through End of Study (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet|||participants|||Number
1253114|NCT00485732|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres|Titres are given as geometric mean titres (GMTs) calculated on all subjects.|Before vaccination (PRE) and one month post Dose 3 (Month 7)|Analysis was performed on the ATP cohort for immunogenicity.|||titre||95% Confidence Interval|Geometric Mean
1252663|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Age|The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
1252664|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized Over Time|The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
1252665|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Severity|The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
1252666|NCT00488514|Primary|Number of Participants With the Indicated Drug-related Adverse Events|The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: >=2% participants recorded as having at least one occurrence of a reported drug-related AE.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
1252667|NCT00488488|Secondary|Overall Mortality: All Participants|Deaths for any reasons occurring during the study observation period.|Baseline to End of Treatment (up to Day 47)|All participants. Overall mortality was not calculated separately for nosocomial and community-acquired infections.|||percentage of participants||95% Confidence Interval|Number
1252668|NCT00488488|Secondary|Reasons for Utilization of Tygacil||Baseline to End of Treatment (up to Day 47)|All participants; n = number of participants with specified reason for utilization of Tygacil.|||percentage of participants|||Number
1252669|NCT00488488|Secondary|Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic|Reasons for change in antibiotic treatment from Tygacil to another antibiotic.|Baseline to End of Treatment (up to Day 47)|All participants; N = number of participants with a documented therapy switch in antibiotic treatment from Tygacil to another antibiotic; n = number of participants with specified reason for switch in antibiotic treatment . Multiple specifications were possible.|||percentage of participants|||Number
1252670|NCT00488488|Secondary|Antibiotic Agents Chosen for Combination Therapy With Tigecycline|Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.|Baseline to End of Treatment (up to Day 47)|All participants; N = number of participants who were concomitantly treated with other antibiotics in combination with Tygacil; n = number of participants who were concomitantly treated with specified antibiotic in combination with Tygacil.|||percentage of participants|||Number
1252671|NCT00488488|Secondary|Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure|Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.|Follow-up (up to Day 47)|All participants; N = number of participants who had a follow-up microbial investigation due to treatment failure; n = number of participants who tested positive for pathogen and had isolates tested for pathogen resistance.|||percentage of participants|||Number
1252672|NCT00488488|Secondary|Participants With Probable Failure at Follow-up|Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.|Follow-up (up to Day 47)|All participants.|||participants|||Number
1252673|NCT00488488|Primary|Percentage of Participants With Composite Cure: Community-acquired Infections|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)|All participants; N = number participants with community-acquired infections.|||percentage of participants|||Number
1252674|NCT00488488|Primary|Percentage of Participants With Composite Cure: Nosocomial Infections|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants; N = number of participants with nosocomial infections.|||percentage of participants|||Number
1252675|NCT00488488|Primary|Percentage of Participants With Composite Cure: All Participants|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants.|||percentage of participants|||Number
1252676|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)|All participants; N = number of participants with community-acquired infections.|||percentage of participants||95% Confidence Interval|Number
1252677|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants; N = number of participants with nosocomial infections.|||percentage of participants||95% Confidence Interval|Number
1263533|NCT00408993|Secondary|Number of Participants Discontinuing Due to Adverse Events||over 12 weeks|Intention to Treat Analysis. All randomized patients.|||participants|||Number
1252678|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: All Participants|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants: participants exposed to Tygacil who had non-retrospective post-baseline data.|||percentage of participants||95% Confidence Interval|Number
1252679|NCT00488475|Other Pre-specified|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy|Participants with or without concomitant methotrexate (MTX) treatment were reported for AEs or SAEs. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Week 2 up to Week 52|Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for specified category.|||participants|||Number
1252680|NCT00488475|Other Pre-specified|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred during the study.|Week 2 up to Week 52|Safety analysis population included all participants with available documentations.|||participants|||Number
1252681|NCT00488475|Other Pre-specified|Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined low disease activity was classified as a score of <=3.2.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
1252682|NCT00488475|Secondary|Fatigue Visual Analog Scale (VAS)|Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Baseline, Week 26, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
1252683|NCT00488475|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 6, 12, 26, 38, 52|Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time points.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1252684|NCT00488475|Secondary|Patient Global Assessment of Disease Activity|Patient global assessment of disease activity was measured using a 100 mm Visual Analog Scale (VAS) ranging from 0 mm= very good to 100 mm = very bad.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
1252685|NCT00488475|Secondary|Physician Global Assessment of Disease Activity|Physician global assessment of disease activity was measured on a 0 mm to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100mm = maximum possible disease activity.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
1252686|NCT00488475|Secondary|Patient Global Assessment of Arthritis Pain|Participants assessed arthritis pain using a 0 mm - 100 mm Visual Analog Scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
1252687|NCT00488475|Secondary|Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If stiffness persisted the entire day, 999 minutes was recorded [largest value possible to document] which may also include values up to 1440 minutes [= complete day]).|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||minutes||Full Range|Median
1253166|NCT00485173|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
1252688|NCT00488475|Secondary|Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)|The DAS28-based European League Against Rheumatism (EULAR) response criteria was used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and level of disease activity reached (final values). Good responders: change from baseline >1.2 with DAS28 final value <=3.2; moderate responders: change from baseline >1.2 with DAS28 final values >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values <=3.2 and >3.2 to <=5.1; non-responders: change from baseline <=0.6 with DAS28 final values <=3.2, >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values >5.1. Good and moderate responders were considered to have DAS28 response.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
1252689|NCT00488475|Secondary|Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined remission was classified as a score of <2.6.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
1252690|NCT00488475|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||millimeter per hour (mm/h)||Standard Deviation|Mean
1252691|NCT00488475|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||joints||Standard Deviation|Mean
1252692|NCT00488475|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||joints||Standard Deviation|Mean
1252693|NCT00488475|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 less than (<) 2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than or equal to (>=) 3.2 to <=5.1 = moderate disease activity, DAS28 greater than (>) 5.1 = high disease activity.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1252694|NCT00488475|Secondary|Duration of Working Disability|"Duration of working disability was assessed as number of days a participant was disable to work. Duration of work disability was considered as 0 if participant was not disable to work during period of assessment. At baseline, participants’ duration of working disability during last 12 months before enrollment into the study was documented. After enrollment, participants’ duration of working disability was documented for last 6 months after previous documentation."|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||days||Full Range|Median
1252695|NCT00488475|Secondary|Duration of Healthcare Resources Utilization|Participants’ duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants’ healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, Week 52|Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points.|||days||Full Range|Median
1263619|NCT00408681|Secondary|Non-relapse Mortality|Death without prior recurrent or progressive malignancy after transplantation.|2 years after enrollment||||Participants|||Count of Participants
1252696|NCT00488475|Secondary|Healthcare Resource Utilization|Participants’ utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants’ healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, Week 52|Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points.|||events||Standard Deviation|Mean
1252697|NCT00488475|Secondary|Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)|WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||percentage of impairment||Standard Deviation|Mean
1252698|NCT00488475|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol group assigns a utility value for each domain in the profile. EQ-5D score is transformed to EQ-5D-TTO score ranging from -0.205 to 0.999; higher score indicates a better health state.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1252699|NCT00488475|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
1252700|NCT00488475|Primary|Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52|Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as “Yes, I can perform the activity without difficulty” (score assigned = 2), “Yes, but with some difficulties” (score assigned = 1) and “No or only with help” (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100%) / (2 * number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%.|Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1252701|NCT00488475|Primary|Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26|Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as “Yes, I can perform the activity without difficulty” (score assigned = 2), “Yes, but with some difficulties” (score assigned = 1) and “No or only with help” (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%.|Week 26|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1252702|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Effect of Weight|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.||||||
1253723|NCT00479674|Secondary|to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy||18 months|Samples were collected, but analysis was not performed as there was inadequate funding to support the testing and analysis of samples.||||||
1252703|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Clearance|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.||||||
1252704|NCT00488345|Primary|Percentage of Participants With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment|CR = Cure: resolution of all signs, symptoms (SS) of infection (INF) or improvement, no further antibacterial therapy (AT) necessary; Improved (IMP): SS IMP to extent that switch to oral AT deemed appropriate; Failure: lack of response, required additional AT, initial recovery then deterioration requiring further AT, death due to the INF after day 2, death due to treatment (TR)-related adverse event (AE), required non-routine surgical TR >48 hours after 1st dose of TR due to failure to IMP or clinical worsening. TOC = CR, vital signs, physical exam, laboratory results, concomitant TR, and AEs.|Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)|mITT|||percentage of participants|||Number
1252705|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Volume of Distribution|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.||||||
1252706|NCT00488345|Primary|Weight Normalized Drug Clearance (CLW)|Weight normalized drug clearance measured in liters per hour per kilogram (L/hr/kg). Drug clearance (CL) was determined as the ratio of dose/area under the concentration-time curve from time zero (start of infusion) to 12 hours (start of next infusion) (AUCτ). CLW was determined as the ratio of CL/weight.|Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)|mITT; N = number of participants with sufficient reported tigecycline concentration data to estimate AUC.|||L/hr/kg||Standard Deviation|Mean
1252707|NCT00488345|Primary|Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours|AUCτ: AUC between doses from time zero to the time of estimated concentration at 12 hours reported in nanograms * hours divided by milliliters (ng*h/mL) was calculated using the log-trapezoidal rule for decreasing concentrations and the linear-trapezoidal rule for increasing concentrations estimating the 12 hour drug concentration if necessary.|Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)|mITT; N = number of participants with sufficient reported tigecycline concentration data to estimate AUC.|||ng*h/mL||Standard Deviation|Mean
1252708|NCT00488345|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Time of peak concentration taken directly from the observed data.|Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)|mITT; N = number of participants with evaluable tigecycline concentration data.|||hours||Standard Deviation|Mean
1252709|NCT00488345|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax: tigecycline serum concentration measured in nanograms per milliliter (ng/mL) determined by a validated liquid chromatography with mass spectrophotometric (LC/MS/MS) detection method. Peak concentration was taken directly from the observed data.|Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)|Modified intent to treat (mITT) population: participants who were screened, assigned to study medication and received at least one dose of study medication. N = number of participants with evaluable tigecycline concentration data.|||ng/mL||Standard Deviation|Mean
1252710|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward|Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days (“very badly” to “very well”) and how often they have felt drowsy within the previous 7 days (“not at all” to “all the time”). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates “Very badly” and a score of 100 indicates “Very well.” For daytime drowsiness, a score of 0 indicates “Not at all” and a score of 100 indicates “All the time.” Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252711|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward|Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days (“very badly” to “very well”) and how often they have felt drowsy within the previous 7 days (“not at all” to “all the time”). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates “Very badly” and a score of 100 indicates “Very well.” For daytime drowsiness, a score of 0 indicates “Not at all” and a score of 100 indicates “All the time.” Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252712|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252713|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252714|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252715|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252716|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252717|NCT00488319|Secondary|Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252718|NCT00488319|Secondary|Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252735|NCT00488293|Primary|Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change score - Symptoms Score|||units on a scale||Standard Deviation|Mean
1252719|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252720|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252721|NCT00488319|Secondary|Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252722|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252723|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252724|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252725|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Children’s Global Assessment Scale (CGAS) - Last Observation Carried Forward|The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252736|NCT00488293|Primary|Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Symptoms Score|||units on a scale||Standard Deviation|Mean
1269178|NCT00367055|Secondary|Median Change From Baseline in Beta Cell Function Index (HOMA-beta) After a 36-month Treatment||Baseline and Month 36|||||||
1252726|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Full Range|Median
1252727|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward|Neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale. PANSS scale provides a total score (sum of scores of all 30 items) and scores for 3 subscales, ie, positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening.|Baseline, Week 104 or the last post-baseline assessment|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252728|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward|The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
1252729|NCT00488319|Primary|The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability|A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to 2 years|The safety analysis set was used for the safety analyses and included all enrolled participants who received at least 1 dose of the open-label study drug as recorded on the electronic case report form. This population was considered as evaluable participants.|||Number of Participants|||Number
1252730|NCT00488293|Secondary|Clinical Course Rating Between Baseline and First Clinic Visit|Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.|Baseline to First Clinic Visit|Clinical course rating between baseline and first clinic visit, if a visit occurred. Timeframe varied and only applied if a first clinic visit occurred.|||participants|||Number
1252731|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Functioning Scores|||units on a scale||Standard Deviation|Mean
1252732|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Functioning Scores|||units on a scale||Standard Deviation|Mean
1252733|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Emotions Score|||units on a scale||Standard Deviation|Mean
1252734|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change score - Emotions Score|||units on a scale||Standard Deviation|Mean
1269179|NCT00367055|Secondary|Median Change From Baseline in Insulin Resistance Index (HOMA-IR) After a 36-month Treatment||Baseline and Month 36|||||||
1252737|NCT00488293|Primary|Skindex-16 Change Scores Baseline to Month 3 - Composite Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Composite Score|||units on a scale||Standard Deviation|Mean
1252738|NCT00488293|Secondary|Clinical Course Rating Between Baseline and Month 9|Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.|Baseline to Month 9|Clinical course rating between baseline and month 9|||participants|||Number
1252739|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Composite Score.|||units on a scale||Standard Deviation|Mean
1252740|NCT00488059|Secondary|Percentage of Patients With Ongoing Injection Site Reactions (ISRs)||Phase I and II||||Percentage of patients|||Number
1252741|NCT00488059|Secondary|CD4+ Lymphocyte Count Change From Baseline|"Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm.~Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II – 12 and 16."|Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF|Intent-to-treat|||cells/mm3||Full Range|Median
1252742|NCT00488059|Secondary|Virologic Response Over Time in Phase II of the Study|The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week.|Weeks II-4, 8, 12 & 16|intent-to-treat population|||participants|||Number
1252743|NCT00488059|Secondary|HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study|Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 & LOCF for ITT patients in Phase I of the study|Baseline and Weeks 4, 8, 12 & LOCF|Intent-to-treat population. Last Observation Carried Forward (LOCF) includes non-missing data values from the last post-baseline visit for each participant which was carried forward to impute missing data values.|||log10 copies/mL||Standard Deviation|Mean
1252744|NCT00488059|Primary|Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16||Week II-16|Intent-to-treat population|||participants|||Number
1252745|NCT00488059|Secondary|Virologic Response Over Time in Phase I of the Study|The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week are summarized below.|Weeks 4, 8 & 12|Intent-to-treat population|||participants|||Number
1252746|NCT00488059|Primary|Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL|Virologic responders were defined as patients who had an initial HIV-1 RNA assessment <= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)|Between Week I-4 and Week I-12 of Phase I of the study|Intent-to-treat population|||participants|||Number
1252747|NCT00488033|Secondary|Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure||4 years||||Participants|||Count of Participants
1252748|NCT00488033|Secondary|Number of Participants With Stroke or Carotid Revascularization Procedure||4 years||||Participants|||Count of Participants
1252749|NCT00488033|Secondary|Number of Participants With Hospitalization for Heart Failure||4 years||||Participants|||Count of Participants
1252750|NCT00488033|Secondary|Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization||4 years||||Participants|||Count of Participants
1252751|NCT00488033|Secondary|Number of Participants Suffering Cardiovascular (CV) Death||4 years||||Participants|||Count of Participants
1252752|NCT00488033|Primary|Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina||4 years||||Participants|||Count of Participants
1252753|NCT00487981|Primary|Pain Rating at 6 Months Post Activation Compared to Baseline||6 months||||Percent reduction||Standard Deviation|Mean
1252754|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Baseline.|Baseline|Full analysis set defined as the number of subjects who had at least one observation after baseline|||Participants|||Number
1252755|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 4|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 is presented here.|Week 4|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
1252756|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 2|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 2 is presented here.|Week 2|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
1252757|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 1|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 1 is presented here.|Week 1|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
1252758|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 4.|Baseline and 4 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
1252759|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 2.|Baseline and 2 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
1252760|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 1.|Baseline and 1 week|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
1252761|NCT00487942|Secondary|Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 4 in the ESS total score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252762|NCT00487942|Secondary|Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 2 in the ESS total score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252763|NCT00487942|Secondary|Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 1 in the ESS total score.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252764|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Endpoint (Week 4 or last observation following baseline) in the ESS total score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline|||Units on a scale||Standard Deviation|Mean
1252788|NCT00487942|Secondary|Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
1253317|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|0.5 hours post-dosing|Modified ITT|||participants|||Number
1252765|NCT00487942|Secondary|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252766|NCT00487942|Secondary|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252767|NCT00487942|Secondary|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252768|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline|||Units on a scale||Standard Deviation|Mean
1252769|NCT00487942|Secondary|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252770|NCT00487942|Secondary|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252771|NCT00487942|Secondary|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1253724|NCT00479674|Secondary|To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers||18 months|Analysis of samples was not performed, as there was inadequate funding to support the testing and analysis of the samples.||||||
1252772|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline|||Units on a scale||Standard Deviation|Mean
1252773|NCT00487942|Secondary|Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252774|NCT00487942|Secondary|Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252775|NCT00487942|Secondary|Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252776|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline|||Units on a scale||Standard Deviation|Mean
1252777|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 or at the last observation following Baseline is presented.|Week 4 or last observation following Baseline|Full analysis set defined as subjects who have at least one observation after Baseline|||Participants|||Number
1252778|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Endpoint which is Week 4 or the last observation following Baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one observation after baseline|||Participants|||Number
1252779|NCT00487942|Secondary|Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Error|Mean
1252780|NCT00487942|Secondary|Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|n The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252781|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at least once after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252782|NCT00487942|Secondary|Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252783|NCT00487942|Secondary|Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252784|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252785|NCT00487942|Secondary|Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
1252786|NCT00487942|Secondary|Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
1252787|NCT00487942|Secondary|Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
1252875|NCT00487552|Post-Hoc|Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD)|Endoscopy was performed to determine whether an anastomosis (hole) was successfully created.|Approximately 8-10 days|Patients who underwent a second endoscopy after successful magnet placement|||participants|||Number
1275996|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||30 days||||Percentage of participants|||Number
1252789|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
1252790|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252791|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252792|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252793|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.|||Units on a scale||Standard Deviation|Mean
1252794|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 in the total score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252795|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 2 in the total score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252796|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline in the total score.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.|||Units on a scale||Standard Deviation|Mean
1264835|NCT00399542|Secondary|Month 3 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1252797|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Error|Mean
1252798|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252799|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252800|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.|||Units on a scale||Standard Deviation|Mean
1252801|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252802|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252803|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252804|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline|||Units on a scale||Standard Deviation|Mean
1254127|NCT00475501|Secondary|Grip Strength kg|Grip strength in the dominant arm will be measured by using a dynamometer. Testing will be performed at baseline, after 3, 6, 9 and 12 months of treatment.|baseline, 3 months, 6 months, 9 months, 12 months||||kg||Standard Error|Mean
1252805|NCT00487942|Secondary|Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
1252806|NCT00487942|Secondary|Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
1252807|NCT00487942|Secondary|Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
1252808|NCT00487942|Secondary|Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
1252809|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
1252810|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
1252811|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
1252812|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
1252813|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
1252814|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
1252815|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in standard deviation of activity (counts/epoch).|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
1252816|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in standard deviation of activity (counts/epoch).|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
1264836|NCT00399542|Secondary|Month 2 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1252817|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in standard deviation of activity (counts/epoch).|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
1252818|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in standard deviation of activity (counts/epoch).|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
1252819|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to endpoint in standard deviation of activity (counts/epoch).|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
1252820|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in maximum activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
1252821|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in maximum activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
1252822|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in maximum activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
1252823|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in maximum activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
1252824|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in maximum activity to Endpoint.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
1252825|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 4.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
1252826|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 3.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
1252827|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 2.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
1252828|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch)to Week 1.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
1252829|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch).|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had a baseline and at least one post-baseline assessment by actigraphy|||Counts||Standard Deviation|Mean
1252830|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test|Trail B is an instrument designed to assess set shifting. The patient was given a paper with numbers and letters on it and asked to connect them in an alternating manner (eg. 1-A-2-B-3C). The time required for the patient to complete the test was recorded. The change from Baseline to last observation following Baseline in the time necessary to complete the test is presented here.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Minutes||Standard Deviation|Mean
1252831|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of sorting categories achieved was assessed."|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Categories Completed||Standard Deviation|Mean
1252832|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of consecutive responses on the final category was assessed."|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Responses||Standard Deviation|Mean
1252833|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. The change from baseline in number of perseveration errors was assessed."|4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Errors||Standard Deviation|Mean
1252834|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The LNS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in LNS T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252835|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The WMS-III SS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in WMS-III SS T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252876|NCT00487552|Primary|Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent|Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.|Approximately 8-10 days||||participants|||Number
1254154|NCT00475241|Secondary|HPA Axis Reactivity Will be Assessed With Collection of Salivary Cortisol at Each Major Assessment. Cortisol Response to Awakening, Our Measure of General Stress Reactivity, Will be Calculated.||pre, mid, post, 3 and 6 mo FU|||||||
1252836|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Fluency Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Fluency Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252837|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The BASC SC Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in BASC SC Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252838|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252839|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252840|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252841|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252877|NCT00487539|Secondary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6|The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.|Baseline to Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a Scale||Standard Deviation|Mean
1252842|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252843|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252844|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252845|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline.|Baseline 4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252846|NCT00487942|Secondary|Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks.|Baseline and 4 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and who had a MATRICS efficacy assessment at baseline and at Week 4. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252847|NCT00487942|Primary|Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
1252878|NCT00487539|Secondary|Number of Participants With Mucosal Healing at Week 6|Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).|Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.|||Participants|||Number
1252848|NCT00487825|Secondary|The Number of Participants in Clinical Remission Based on Disease Activity Score (DAS)28 and Simplified Disease Activity Index (SDAI)|"At each visit (including baseline) the DAS28 and SDAI variables were derived using the following formulas:~DAS28 = 0.56*√ (tender28) + 0.28 * √ (swollen28) + 0.36 * loge(CRP+1) + 0.014*PGDA+ 0.96; SDAI = tender28 + swollen28 + CRP + (PGDA / 10) + (EGDA / 10) where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, CRP is C-reactive protein, PGDA is the patient’s global assessment of disease activity and EGDA is the physician’s global assessment of disease activity.~The Number of Participants in clinical remission is defined as the DAS28 ≤ 2.6 or SDAI ≤ 3.3."|At 6 weeks, 14 weeks and 24 weeks|Intention to treat (ITT) population|||Participants|||Number
1252849|NCT00487825|Secondary|Percentage of Participants Achieving a Good European League Against Rheumatism (EULAR) Response (Based on the Disease Activity Score (DAS28)) at 26 Weeks|At each visit (including baseline) the DAS28 is derived as: DAS28 = 0.56*√ (tender28) + 0.28 * √ (swollen28) + 0.36 * loge(CRP+1) + 0.014*PGDA+ 0.96; where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, PGDA is the patient’s global assessment of disease activity. Patients can be scored on a range of 0 to 10. When current DAS < 3.2, good response is defined as >1.2 improvement in DAS from baseline and non-response is improvement of ≤0.6. When current DAS >5.1, non-response is improvement of >0.6 but ≤1.2 . All others are moderate responses.|At 26 weeks|Intention to treat (ITT) population|||Percentage of Participants|||Number
1252850|NCT00487825|Secondary|Response to Intravenous (IV) Canakinumab and Oral Methotrexate (MTX) Therapy (ACR20, 70, 90) Compared to MTX Alone|"A patient was considered as improved according to the criteria of ACR 20 equaling at least 20%, ACR70 = 70%, and ACR90 = 90% improvement in the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient’s pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient’s global assessment of disease activity (VAS 100 mm)~Physician’s global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|At 6 weeks, 14 weeks, and 26 weeks|Intent-to-treat population (ITT)|||Participants|||Number
1252851|NCT00487825|Primary|Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50)|"A patient was considered as improved according to the ACR50 criteria if she/he had at least a 50 % improvement in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient’s pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient’s global assessment of disease activity (VAS 100 mm)~Physician’s global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|6, 14, and 26 weeks of treatment|Intent-to-treat population (ITT)|||Participants|||Number
1252852|NCT00487747|Secondary|Mean Change in Laboratory Parameters (ALT Levels)|Mean Change in Laboratory parameters (ALT levels) is reported.|From Screening (Day 0) to Week 96|Safety population included all participants who received at least one dose of the study drug.|||International units per liter (IU/L)||Standard Deviation|Mean
1252853|NCT00487747|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.|Up to Week 96|Safety population included all participants who received at least one dose of the study drug.|||Participants|||Number
1252854|NCT00487747|Secondary|Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT|Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.|||Participants|||Number
1252855|NCT00487747|Secondary|Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion|Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.|||Participants|||Number
1252856|NCT00487747|Primary|Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL|This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.|||Participants|||Number
1252857|NCT00487747|Primary|Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL|This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.|||Participants|||Number
1252858|NCT00487721|Primary|Measurable Silibinin Tissue Levels|To determine if measurable silibinin tissue levels are detectable in the prostate glands of men treated with Silybin-Phytosome administered according to the protocol. Analysis of silibinin in human fluid and tissue samples was carried out by Liquid chromatography - mass spectrometric (LC/MS/MS) following liquid extraction. Briefly, sample was extracted in acidified ethyl acetate by vortex. Following centrifugation, the organic layer was evaporated to dryness in a rotary evaporator and the samples were dissolved in acetonitrile/ammonium acetate with acetic acid for analysis. Sample analysis was done using an Applied Biosystems 3200 Q-Trap 1 triple quadrupole mass spectrometer with an Agilent 1100 Liquid Chromatography system and HTC-PAL Leap Autosampler. Quantitation of silibinin in samples was done by internal standard reference and batch analysis verified by the inclusion of spiked quality control samples in the appropriate matrix.|At the time of surgery|Per protocol analysis was used and 6 participants that were enrolled in the study were included in the analysis.|||Participants|||Number
1252963|NCT00486954|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study|Pharmacokinetic (PK) samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.|Days 8 and 14|PK Parameter Population: all participants for whom the PK parameter could be estimated|||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1252859|NCT00487695|Secondary|Mean Number of Biopsies Taken in Barrett's Surveillance Patients|The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia).|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete, the study, no comparison could be made. The patients in this analysis were referred for surveillance of Barrett's esophagus (no suspected neoplasia).|||mean number of biopsies||Full Range|Mean
1252860|NCT00487695|Secondary|Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients|The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia).|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.|||number of biopsies with neoplasia||Full Range|Mean
1252861|NCT00487695|Secondary|Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients|Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia).|6 weeks|Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed).|||percent yield for neoplasia|||Number
1252862|NCT00487695|Secondary|Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)|The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia.|6 weeks|per protocol as participants would only have data to compare if they completed both endoscopies|||mean number of biopsies||Full Range|Mean
1252863|NCT00487695|Secondary|Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)|The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia.|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.|||mean number of biopsies with neoplasia||Full Range|Mean
1252864|NCT00487695|Primary|Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)|The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)|6 weeks|Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed. This analysis looks specifically at patients with Barrett's and suspected (but not known) neoplasia.|||percent yield for neoplasia|||Number
1252865|NCT00487669|Secondary|Overall Survival||time from study entry until death||||months||95% Confidence Interval|Median
1252866|NCT00487669|Secondary|Time to Progression||time from study entry until the first documented sign of progression||||months||95% Confidence Interval|Median
1252867|NCT00487669|Primary|To Evaluate the Overall Response Rate (Complete Plus Partial Responses by RECIST Criteria) to the Combination of Paclitaxel Poliglumex and Pemetrexed as Therapy in Patients With Advanced NSCLC.||CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days)||||participants|||Number
1252868|NCT00487578|Secondary|Sustained Treatment Effect|Sustained treatment effect as measured by the MEWT Performance Index score compared to change in number of Headache Days. Results would be presented in the form of a correlation analysis. There is an expected negative correlation as performance index increases and number of headache days decrease (a correlation of -1).|Day 0, Day 10, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
1252869|NCT00487578|Secondary|Quality of Life Scores|"Quality of life as measured by Migraine Specific Quality of Life questionnaire (MSQ) scores. 14 questions ask how often headaches have interfered with specific daily activities in previous 4 weeks. 6-point scale ranges from None of the time to All of the time."|Day 0, Day 30, Day 90|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
1252870|NCT00487578|Secondary|Overall Satisfaction With Medication Score|Subject overall satisfaction with effectiveness of the therapy as measured by score on the Satisfaction with Medication questionnaire. Scale range: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied.|Day 30, Day 90|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
1252871|NCT00487578|Primary|Mental Efficiency Workload Test (MEWT) Performance Index Score|Cognitive function as measured by Performance Index scores on the Mental Efficiency Workload Test (MEWT). On the performance index scale of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. Tests include: Simple reaction time, Running memory, Matching to sample, Math processing and a sleep scale.|Day 0, Day 10, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
1252872|NCT00487578|Primary|Headache Impact Test-6 (HIT-6) Score|Impact of headache symptoms on subject's life as measured by HIT-6 questionnaire scores. Possible scores range from 36 to 78. Score of 48 or less indicates headache has little impact on life. Score of 60-78 indicative of very severe impact.|Day 0, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
1252873|NCT00487578|Primary|Headache Days|Number of headache days as measured by the Headache Diary|Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
1252874|NCT00487565|Primary|Knee Active Flexion|Active flexion is measured by how much a patient can bend their knee on their own, without assistance.|12 month||||degrees||Standard Deviation|Mean
1252879|NCT00487539|Secondary|Number of Participants With Clinical Remission at Week 6|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.|||Participants|||Number
1252880|NCT00487539|Primary|Number of Participants With Clinical Response at Week 6|Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Baseline, Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.|||Participants|||Number
1252881|NCT00487461|Secondary|To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up|Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.|6 months|Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.||||||
1252882|NCT00487461|Primary|To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH||21 days|Study PI left before outcome data was collected for the study and therefore the Outcome(s) will never be analyzed.||||||
1252883|NCT00487435|Secondary|Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)|"The subjects indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, 52 weeks|observed cases|||Scores on a Scale||Standard Deviation|Mean
1252884|NCT00487435|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|The number of subjects who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|52 weeks|Safety analysis set (All randomized subjects who took at least one dose of study medication).|||participants|||Number
1252885|NCT00487396|Secondary|The Additional Diagnostic Value and Sensitivity of CE Compared With Ileo-colonoscopy and SBFT Will be Evaluated by the Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related.||four months from enrollment|||||||
1252886|NCT00487396|Secondary|Small Bowel Disease Present (Will be Categorized as Mild, Moderate or Severe)or Suspicious for Small Bowel Disease or No Small Bowel Disease Present.||four months from enrollment|||||||
1252887|NCT00487396|Primary|The Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related|The number of positive findings related to Crohn that were detected by capsule endoscopy procedure and ileo-colonoscopy as compared to the number of findings related to Crohn that were detected by ileo-colonoscopy and small bowel follow through(SBFT) procedures.|four months from enrollment|Findings were catagorized (ulcers, inflammatory lesions, stricturing lesions and others) and for each category, the numbers of found and missed pathologies, i.e. the detection capabilities, were calculated for the combination of the procedures (i.e. CE and IC vs. SBFT and IC) and were limited to one count per location (SB, terminal ileum, colon).|||Number of findings|||Number
1252888|NCT00487279|Secondary|Arrhythmic Mortality|Arrhythmic mortality was reported as the number of randomized patients who died due to arrhythmic death. Arrhythmic death was defined as death due to arrhythmia or sudden death.|Total survival will be evaluated 2 years after the last patient is randomized.||||participants|||Number
1252889|NCT00487279|Primary|All-cause Mortality||Total survival will be evaluated 2 years after the last patient is randomized.|Intent to Treat|||participants|||Number
1252890|NCT00487240|Secondary|Insulin Dose (Total and By Component [Basal and Bolus])|Total daily insulin dose (U/day) was assessed.|32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||units of insulin per day (U/day)||Standard Deviation|Mean
1252891|NCT00487240|Secondary|Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])|Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||units of insulin per kilogram per day||Standard Deviation|Mean
1252892|NCT00487240|Secondary|Change From Baseline in Absolute Body Weight at 32 Week Endpoint||Baseline, 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.|||kilograms||Standard Deviation|Mean
1252893|NCT00487240|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint||baseline to 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||hypoglycemic events per 30 days||Standard Deviation|Mean
1252907|NCT00487188|Secondary|Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts|Change from Baseline in CD4 Cell Counts at Week 48. Least squares means were calculated from an ANCOVA model with treatment and baseline CD4 count as independent variables.|Baseline 1 and Week 48|Intent-to-Treat Population 2 (ITT2) population (patients evaluable for efficacy in the Maintenance Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 48 or who withdrew prior to the week 48 time window.|||cells/mm^3||95% Confidence Interval|Least Squares Mean
1252894|NCT00487240|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint|Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|baseline to 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||hypoglycemic events per 1 year||Standard Deviation|Mean
1252895|NCT00487240|Secondary|Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint|Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline to 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||episodes of hypoglycemia|||Number
1252896|NCT00487240|Secondary|Glycemic Variability at Endpoint|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose [SMBG] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1252897|NCT00487240|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint|Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1252898|NCT00487240|Secondary|Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%||32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||percentage of participants|||Number
1252899|NCT00487240|Secondary|Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values|"The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the mean change from baseline is calculated by averaging out for all subjects. [Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline."|Baseline, 8,16, 24, 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.|||percent of HbA1c||Standard Error|Least Squares Mean
1252900|NCT00487240|Primary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint||baseline and 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||percent of HbA1c||Standard Error|Least Squares Mean
1252901|NCT00487188|Secondary|Number of Participants With Adverse Events (AEs) During the Induction Phase|A serious AE (SAE) is an event which: results in death, is life-threatening, disabling or incapacitating; is a congenital anomaly in the offspring of a patient who received study drug; requires or prolongs inpatient hospitalization; jeopardizes the patient or require medical or surgical intervention to prevent one of the outcomes above; any Grade 4 laboratory value considered by the investigator clinically significant or that requires an action; any injection site reaction that meets SAE criteria above. Non-serious AEs reported include pneumonia and non-serious AEs that led to discontinuation.|Start of the study treatment until the end of the Induction Phase (Week 12 to Week 32)|Safety Population|||participants|||Number
1252902|NCT00487188|Secondary|Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase|Improvement of CD4+ count defined as having from 100 to less than 200 CD4+ cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.|Baseline 2 to Week 48.|Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of ≥100 to <200 cells/mm^3.|||percentage of participants|||Number
1252903|NCT00487188|Secondary|Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase|Maintenance of CD4+ count defined as having greater than or equal to 200 cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.|Baseline 2 to Week 48.|Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of greater than or equal to 200 cells/mm^3.|||percentage of participants|||Number
1252904|NCT00487188|Secondary|Number of Participants With Virological Failure During the Maintenance Phase|Virological failure was defined by 2 consecutive HIV-1 RNA values ≥ 400 copies/mL during the Maintenance Phase.|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)|||Participants|||Number
1252905|NCT00487188|Secondary|Time to Virological Failure During the Maintenance Phase|"Time to virological failure (defined as HIV-1 RNA ≥ 400 copies/mL) was counted from Baseline 2 until the first of the two consecutive ≥400 copies/mL measurements.~Only patients who were qualified for entering the Maintenance Phase were included in the analyses."|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)|||days||Inter-Quartile Range|Median
1252906|NCT00487188|Secondary|Time to Loss of Viral Response During the Maintenance Phase|"The time to loss of viral response (defined as HIV-1 RNA <50 copies/mL) was counted from Baseline 2 until the first of two consecutive ≥50 copies/mL measurements.~Only patients who were qualified for entering the Maintenance Phase were included in the analysis."|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)|||days||Inter-Quartile Range|Median
1252960|NCT00486954|Secondary|Cmax of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.|Days 1 and 8|PK Parameter Population|||ng/mL||95% Confidence Interval|Geometric Mean
1252908|NCT00487188|Secondary|Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks|The percentage of participants from the Maintenance Phase who maintained HIV-1 RNA < 50 copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.|Week 48|Maintenance Phase Intent-to-Treat Population 2 (ITT2).|||percentage of participants|||Number
1252909|NCT00487188|Secondary|Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks|The percentage of participants from the Induction Phase who maintained HIV-1 RNA < 50 Copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.|Week 48|Induction Phase Intent-to-Treat Population 1 (ITT1).|||percentage of participants|||Number
1252910|NCT00487188|Secondary|Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts|Change from Baseline in CD4+ Cell Counts at Week 24. Least squares means were calculated from an ANCOVA model with treatment as an independent variable.|Baseline and Week 24|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.|||cells/mm^3||95% Confidence Interval|Least Squares Mean
1252911|NCT00487188|Secondary|Change From Baseline to Week 24 in Viral Load|"Change from Baseline in log10 HIV-1 RNA at Week 24. Least squares means were calculated from an analysis of covariance (ANCOVA) model with treatment, a flag variable removed ENF at re-randomization and Baseline viral load as independent variables."|Baseline and Week 24|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.|||log10 copies/mL||95% Confidence Interval|Least Squares Mean
1252912|NCT00487188|Secondary|Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase|Participants whose viral load achieved suppression (HIV-1 RNA < 400 copies/mL) by Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by Week 28 were considered as non-responders.|From Baseline 1 to Week 28|ITT1 population (patients evaluable for efficacy in the induction phase)|||Participants|||Number
1252913|NCT00487188|Secondary|Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase|"The time to achieving HIV-1 RNA <50 copies/mL was counted from Baseline 1 until the first of the two consecutive <50 copies/mL measurements.~Patients who discontinued from the study or patients who did not have confirmed virological response by week 28 were classed as non-responders and censored at Week 24."|Baseline 1 until Week 28.|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase).|||days||Inter-Quartile Range|Median
1252914|NCT00487188|Primary|Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase|Participants whose viral load achieved suppression (HIV-1 RNA < 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.|From Baseline 1 to Week 28|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase)|||Participants|||Number
1252915|NCT00487162|Secondary|Hemodynamic Instability||0-48 hours post op|no analysis was done as the study was terminated due to patient safety concerns||||||
1252916|NCT00487162|Primary|Wound Infection||7-10 days post op|no analysis was done as the study was terminated due to patient safety concerns||||||
1252917|NCT00487084|Secondary|Supplemental Analgesia in First 48 Hours|Participants requesting supplemental analgesia in first 48 hours|48 hours||||Participants|||Number
1252918|NCT00487084|Primary|Supplemental Analgesia in First 90 Minutes|Participants requesting supplemental analgesia in the first 90 minutes following study drug|90 min||||participants|||Number
1252919|NCT00487084|Secondary|Verbal Rating Score (0 to 10) for Pain (VRPS)|Verbal Rating Pain Score (VRPS) at time of post-anesthesia recovery room entry, where 0 = no pain and 10 = worst pain imaginable|At recovery room entry|Verbal Rating Score for Pain (0-10) where 0 = no pain and 10 = worst pain imaginable|||Scores on a scale||Inter-Quartile Range|Median
1252920|NCT00487084|Primary|Duration of Continuing Analgesia|Time to first request for supplemental analgesia|48 hours|All participants receiving the intervention were analyzed|||hours||95% Confidence Interval|Median
1252921|NCT00486954|Secondary|Number of Participants With Mutations That May Correlate With Response and Toxicity to Lapatinib|An inadequate number of tissue samples were obtained; thus, analysis could not be performed.|Pretreatment|ITT Population||||||
1252922|NCT00486954|Secondary|Number of Participants With the Indicated Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry Intensity in the Randomized Part of the Study|"HER2 protein expression on the surface of cells in gastric cancer tissue samples was measured using a monoclonal antibody specific for the extracellulr region of HER2, and the degree of membrane staining was evaulated. The immunohistochemistry test gives a score of 0 to 3+ and measures the amount of HER2 receptor protein on the surface of cells in a gastric cancer tissue sample. Score of 0 to 1+, HER2 negative; score of 2+, borderline; score of 3+, HER2 positive."|Pretreatment|ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.|||participants|||Number
1252923|NCT00486954|Secondary|Number of Participants With the Indicated Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry Intensity in the Randomized Part of the Study|EGFR protein expression on the surface of cells in gastric cancer tissue samples was measured using a moncolonal antibody specific for the extracellular region of EGFR, and the degree of membrane staining was evaluated. 3+ indicates positive EGFR expression; <3+ indicates negative EGFR expression.|Pretreatment|ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.|||participants|||Number
1253062|NCT00486278|Secondary|Number of Subjects With Need for Additional Haemostatic Agents||within 24 hours after successful control of bleeding episode with trial product|All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 9 subjects did not contribute to the data.|||participants|||Number
1252924|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252925|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252926|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252927|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252928|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252929|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252930|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252931|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252961|NCT00486954|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study|PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14. AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after oral adminisation.|Days 8 and 14|PK Parameter Population|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1257467|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 24|Value at Week 24 minus value at baseline.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1252932|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252933|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252934|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252935|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252936|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252937|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252938|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252939|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252962|NCT00486954|Secondary|Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study|PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.|Days 8 and 14|PK Parameter Population|||hours (hr)||Full Range|Median
1288221|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12||Month 12||||L||Standard Error|Mean
1252940|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252941|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252942|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252943|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252944|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252945|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252946|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1252947|NCT00486954|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
1260642|NCT00428441|Primary|Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels|Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis|1 year||||participants|||Number
1252948|NCT00486954|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study|The Common Terminology Criteria for Advere Events (CTCAE) is a descriptive terminology that can be used for AE reporting. Grade (G) refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade (G) refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE.|From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part)|Safety Population: all participants who were randomized and took at least one dose of study medication|||participants|||Number
1252949|NCT00486954|Secondary|Duration of Response in the Randomized Part of the Study|Duration of response was defined as the time from the first documented evidence of CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD) until the first documented sign of disease progression (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions) or death due to any cause, if sooner.|up to 18.27 months|ITT Population. Only those participants achieving a CR or PR were assessed.|||months||95% Confidence Interval|Median
1252950|NCT00486954|Secondary|Number of Participants With the Indicated Time to Response in the Randomized Part of the Study|Time to response was defined as the time from randomization to CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD). For participants who did not achieve a CR or PR, time to response was censored at the last assessment prior to other cancer therapies. For censored participants, time to response was defined as the time from randomization to the time of the last assessment prior to the administation of other cancer therapies.|up to 5.62 months|ITT Population. Only those participants achieving a CR or PR were assessed.|||Participants|||Number
1252951|NCT00486954|Secondary|Percentage of Participants With Overall Response in the Randomized Part of the Study|Overall response was defined as the percentage of participants achieving either complete response (CR) or partial response (PR). Per RECIST, version 1.0, CR was defined as the disappearance of all target lesions, and PR was defined as a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|From randomization up to 5.62 months|ITT Population|||Percentage of participants|||Number
1252952|NCT00486954|Secondary|Time to Progression in the Randomized Part of the Study|Time to progression was defined as the time from randomization until the earliest date of disease progression or death due to disease. Per RECIST, version 1.0, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|From randomization until disease progression or death due to disease (up to 42.35 months )|ITT Population|||months||95% Confidence Interval|Median
1252953|NCT00486954|Secondary|Progression-free Survival (PFS) in the Randomized Part of the Study|PFS was defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|From randomization until disease progression or death due to any cause (up to 42.35 months)|ITT Population. For participants whose disease did not progress or who did not die, PFS was censored at the time of the last independently assessed radiological scan preceding the initiation of any alternate anti-cancer therapy.|||months||95% Confidence Interval|Median
1252954|NCT00486954|Secondary|Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Vss is the volume of distribution at steady state of paclitaxel.|Days 1 and 8|PK Parameter Population|||liters per square meter||95% Confidence Interval|Geometric Mean
1252955|NCT00486954|Secondary|Clearance of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Clearance is defined as the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Days 1 and 8|PK Parameter Population|||liters per hour per square meter||95% Confidence Interval|Geometric Mean
1252956|NCT00486954|Secondary|Half-life of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half.|Days 1 and 8|PK Parameter Population|||hr||95% Confidence Interval|Geometric Mean
1252957|NCT00486954|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-inf) is area under the plasma concentration-time curve from the start of infusion (time 0) extrapolated to infinity.|Days 1 and 8|PK Parameter Population|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1252958|NCT00486954|Secondary|AUC(0-24) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from the start of infusion (time 0) to 24 hours after the start of the infusion.|Days 1 and 8|PK Parameter Population|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1252959|NCT00486954|Secondary|Tmax of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.|Days 1 and 8|PK Parameter Population|||hr||Full Range|Median
1252964|NCT00486954|Primary|Overall Survival (OS) in the Randomized Part of the Study|OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.|From randomization until death due to any cause (up to 42.58 months)|Intent-to-Treat Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication|||months||95% Confidence Interval|Median
1252965|NCT00486954|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study|DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting >=7 days, thrombocytopenia (<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of >5 days, for Days 8 or 15 of weekly paclitaxel.|28 days|Safety Population (Pilot part): all participants who received at least one dose of investigational product in the Pilot part of the study|||Participants|||Number
1252966|NCT00486902|Post-Hoc|Pain Score (0-10) at 2 Weeks Following Cesarean Delivery|Numeric rating for pain score (0 to 10) reported at 2 weeks following cesarean delivery. Zero is no pain and 10 is worst pain imaginable.|2 weeks||||Scores on a scale||Inter-Quartile Range|Median
1252967|NCT00486902|Secondary|Disturbing Dreams|Number of subject reporting disturbing dreams at 72 hours post cesarean delivery|72 hours||||participants|||Number
1252968|NCT00486902|Secondary|Postperative Pruritus|Number of subjects with pruritus in the first 24 hours following cesarean delivery|24 hours||||participants|||Number
1252969|NCT00486902|Secondary|Postoperative Vomiting|Number of subjects that vomited in the first 24 hours following cesarean delivery|24 hours||||participants|||Number
1252970|NCT00486902|Secondary|Postoperative Nausea|Number of subjects reporting nausea in first 24 hours following cesarean delivery|24 hours||||participants|||Number
1252971|NCT00486902|Secondary|Cumulative Hydrocodone/Acetaminophen for Supplemental Analgesia to Treat Breakthrough Pain|Cumulative hydrocodone/acetaminophen for supplemental analgesia to treat breakthrough pain for 72 hours following cesarean delivery|72 hours|Analysis was per protocol|||tablets||Inter-Quartile Range|Median
1252972|NCT00486902|Secondary|Verbal Pain Scores (0 to 10) at First Analgesia Request|Numeric rating of pain scores (NRS) scale (0 to 10) at time of supplemental analgesia request. Zero is no pain and 10 is worst pain imaginable.|24 hours||||Scores on a scale||Inter-Quartile Range|Median
1252973|NCT00486902|Primary|Number of Subjects Requiring Supplemental Analgesia in the First 24 Hours Following Cesarean Delivery|Request for oral hydrocodone/acetaminophen for pain not controlled by around the clock non-steroidal antiflammatory drugs in the first 24 hours following cesarean delivery.|24 hours|Analysis was performed per protocol|||participants|||Number
1252974|NCT00486863|Secondary|4-hydroxy Praziquantel Pharmacokinetic Concentrations|Since pregnancy is associated with increased cytochrome P450 activity and physiologic changes in the gastrointestinal tract that tend to reduce drug absorption, praziquantel pharmacokinetics may be affected by pregnancy. Thus, the metabolite-to-parent drug ratio may serve as a differential marker to help determine if variability in drug exposure following oral administration during pregnancy is due to altered metabolism or drug absorption. Samples that were collected from subjects who were randomized to receive praziquantel were analyzed for praziquantel and 4-hydroxy praziquantel concentrations. Assays were performed using high performance liquid chromatography–electrospray mass spectrometry in the University of California at San Diego Pediatric Clinical Pharmacology Laboratory. Descriptive statistics were obtained for concentrations at each of the four sparse sampling timepoints.|4.5 and 8 hours after the first praziquantel dose (subjects assigned to an even study number) or 6 and 10 hours after the first praziquantel dose (subjects assigned to an odd study number).|The analysis population for pharmacokinetics descriptive analyses was defined as all subjects who had plasma samples collected and who were randomized to receive PZQ (N=99; 50 subjects at 4.5 and 8 hr after first PZQ dose and 49 at 6 and 10 hr after first PZQ dose).|||ng/ml||Inter-Quartile Range|Median
1252975|NCT00486863|Secondary|Praziquantel Pharmacokinetic Concentrations|Two plasma samples were collected during the overnight hospitalization from approximately 200 subjects that remained at the time of study modification to incorporate PK studies. Subjects had samples collected based on one of two sample collection strategies: 4.5 and 8 hr after the first praziquantel dose or 6 and 10 hr after the first praziquantel dose. Subjects randomized to an even study number were assigned to the 4.5 and 8 hour schedule. Subjects randomized to an odd study number were assigned to the 6 and 10 hour schedule. Samples only from subjects randomized to receive praziquantel were analyzed for praziquantel. Samples drawn from subjects randomized to the control group were not analyzed. Praziquantel concentrations (ng/ml) were assayed using high performance liquid chromatography–electrospray mass spectrometry in the University of California at San Diego Pediatric Clinical Pharmacology Laboratory.|4.5 and 8 hours after the first praziquantel dose (subjects assigned to an even study number) or 6 and 10 hours after the first praziquantel dose (subjects assigned to an odd study number).|The analysis population for pharmacokinetics descriptive analyses was defined as all subjects who had plasma samples collected and who were randomized to receive PZQ (N=99; 50 subjects at 4.5 and 8 hr after first PZQ dose and 49 at 6 and 10 hr after first PZQ dose).|||ng/mL||Inter-Quartile Range|Median
1252976|NCT00486863|Secondary|Cytokeratin 18 Neo-epitope Staining as a Measure of Apoptosis|A study hypothesis was that peripheral serum obtained from S. japonicum infected, treated mothers would induce a lower level of apoptosis (programmed cell death) in cultured trophoblasts as measured by cytokeratin 18 neo-epitope staining compared to peripheral serum obtained from S. japonicum infected, PZQ untreated mothers. This assay was planned to be completed only if the primary objective was met; therefore, there will be no data for this outcome measure.|32 weeks gestation|||||||
1252977|NCT00486863|Secondary|Placental Blood Cytokine Levels|Cytokine assays were planned to be performed with culture supernatant harvested from placental explant cultures. The cytokines were to be measured with a multi-analyte analyzer. These assays were intended to be performed only if the primary objective of the study was met; therefore, there will be no results reported for this outcome measure.|At delivery|||||||
1288222|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6||Month 6||||L||Standard Error|Mean
1252978|NCT00486863|Secondary|Maternal Serum Cytokine Levels of TNF-alpha, TNF-alpha Receptors I and II, IL-1, and IL-6|Extra-placental mechanisms mediating improved outcomes in the PZQ group were planned to be evaluated with maternal serum cytokine levels, particularly TNF-alpha, TNF-alpha receptors I and II, IL-1, and IL-6. These assays were intended to be performed only if the primary objective of the study was met; therefore, there will be no results reported for this outcome measure.|At 32 weeks gestation|||||||
1252979|NCT00486863|Secondary|Number of Participants With Pre-eclampsia|Participants were assessed for the presence of pre-eclampsia at both the 22 and 32 week visits. Pre-eclampsia was defined by the presence of proteinurea (2+ protein on urine dipstick) and a single diastolic blood pressure reading of 100 millimiters of mercury (mm Hg) or above OR more than one reading, four hours apart, of 90 mm Hg or above.|22 weeks and 32 weeks|All participants seen at both timepoints are included.|||participants|||Number
1252980|NCT00486863|Secondary|Number of Participants Whose Infant Was Born With Congenital Anomalies|The newborn was examined by the midwife at delivery and within 2-6 days of delivery to assess the presence of congenital anomalies and well-being. The newborn was also examined by study pediatrician at 28 days of life.|At delivery, within 2-6 days of delivery, and at 28 days|All newborns are included in the analysis.|||participants|||Number
1252981|NCT00486863|Secondary|Number of Participants Reporting Abnormalities in Clinical Chemistry Assessments Within 24 Hours of Dosing|Toxicity to maternal kidney and liver was assessed by laboratory parameters collected just before and 24 hours after dosing. Specifically, blood was drawn just before the dose at 12-16 weeks gestation to determine baseline blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin. Blood was then drawn 24 hours after the second part of the split dose and before discharge from the hospital to assess any changes in these parameters. Any values that were 1.1 times the upper limit of normal or greater for the parameter were considered abnormal.|Just before and 24 hours after dosing|All participants were included in this analysis.|||participants|||Number
1252982|NCT00486863|Secondary|Number of Participants Reporting Abnormalities in Hematology Assessments Within 24 Hours of Dosing|Toxicity to maternal bone marrow, kidney, and liver was assessed by laboratory parameters collected just before and 24 hours after dosing. Specifically, blood was drawn just before the dose at 12-16 weeks gestation to determine baseline complete blood count, including white blood count (WBC), platelets, and hemoglobin. Blood was then drawn 24 hours after the second part of the split dose and before discharge from the hospital to assess any changes in these parameters. White blood count was abnormal at or above 10,800 or at or below 3500 cells/square millimeter (sq mm), platelets were abnormal at or below 140,000 cells/sq mm, and hemoglobin was abnormal at or below 10.9 grams/deciliter (g/dL).|Just before and 24 hours after dosing|All participants were included in this analysis.|||participants|||Number
1252983|NCT00486863|Secondary|Number of Participants Experiencing Fetal Loss by Abortion|Abortion was defined by the protocol as bleeding followed by fetal loss as supported by ultrasound before 20 weeks gestation. Abortion was an important safety outcome measure due to the fact that abortion would occur closer to the time of dosing than miscarriage or stillbirth. Participants were observed in hospital for 24 hours after dosing and asked to return for any bleeding at any time.|After dosing and before 20 weeks gestation|All participants were included in this analysis.|||participants|||Number
1252984|NCT00486863|Secondary|Number of Participants Reporting Serious Adverse Events Within 24 Hours of Dosing|Participants were observed in hospital for 24 hours after dosing for serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof (for reasons other than the 24-hour observation period); resulted in a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of these outcomes.|Within 24 hours of dosing|All participants were included in this analysis.|||participants|||Number
1252985|NCT00486863|Secondary|Number of Subjects With Reduction in S. Japonicum Egg Counts From Screening to 22 Weeks Gestation of Greater Than 90 Percent|Parasitologic response to treatment was evaluated by counting S. japonicum eggs per gram of stool at screening and again at 22 weeks gestation. Success of treatment was pre-specified as greater than 90 percent reduction in egg count from screening to 22 weeks gestation.|Screening and 22 weeks gestation|All participants for whom egg counts were reported are included in the analysis.|||participants|||Number
1252986|NCT00486863|Secondary|Newborn Median Serum Transferrin Receptor:Ferritin Ratio|To assess total body iron, the serum transferrin receptor:ferritin ratio was assessed in the infant. At delivery, a heel stick blood sample and a cord blood sample were collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio.|0-6 days after delivery.|All infants for whom transferrin receptor and ferritin were reported are included in the analysis.|||ratio||Inter-Quartile Range|Median
1252987|NCT00486863|Secondary|Mean Change in Maternal Thigh Skinfold Thickness From 14 to 32 Weeks Gestation|Maternal fat stores were measured by thigh skinfold thickness obtained using a Holtain skinfold caliper. The thickness increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.|14 and 32 weeks gestation|All participants for whom thigh skinfold thickness was reported at both timepoints were included in this analysis.|||millimeters||Standard Deviation|Mean
1252988|NCT00486863|Secondary|Mean Change in Maternal Weight From 14 to 32 Weeks Gestation|Maternal weight gain was assessed by measuring participants' weight in kilograms. The weight increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.|14 and 32 weeks gestation|All participants for whom weight was reported at both timepoints were included in this analysis.|||kilograms||Standard Deviation|Mean
1252989|NCT00486863|Secondary|Median Maternal Hepcidin at 32 Weeks Gestation|Anemia of inflammation was assessed via maternal urine hepcidin levels. In response to inflammation, elevated serum levels of hepcidin is synthesized. Hepcidin causes sequestration of iron from bio-available forms to storage forms such as ferritin and decreases intestinal absorption of iron. Hepcidin was measured in participants' urine at 32 weeks gestation.|32 weeks gestation|All participants for whom hepcidin levels were reported are included in the analysis.|||nanograms/milliliter||Inter-Quartile Range|Median
1253318|NCT00483717|Primary|The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|2 hours after dosing|Modified ITT|||participants|||Number
1252990|NCT00486863|Secondary|Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation|To assess total body iron, one needs to assess the storage compartment, which will contain sequestered iron, and the functional compartment, which represents bioavailable iron. Body iron status is defined by the two laboratory measurements that reflect these compartments, ferritin and serum transferrin receptor. The serum transferrin receptor:ferritin ratio has been shown in quantitative phlebotomy studies to provide an accurate assessment of total body iron over the entire range of status. At 14 and 32 weeks gestation, a blood sample was collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio. Each participant's change in ratio was calculated, and the median and interquartile range were determined for each group.|14 weeks and 32 weeks gestation|All participants for whom transferrin receptor:ferritin ratio was reported at both timepoints are included in the analysis.|||ratio||Inter-Quartile Range|Median
1252991|NCT00486863|Secondary|Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation|Hemoglobin concentration in a venous blood sample collected at 14 and 32 weeks gestation was measured using a multi-analyte analyzer. Each participant's change in hemoglobin concentration between the two timepoints was determined, and the mean and standard deviation for each group calculated.|14 weeks and 32 weeks gestation|All participants for whom hemoglobin concentrations were reported are included in the analysis.|||grams/deciliter||Standard Deviation|Mean
1252992|NCT00486863|Secondary|Number of Participants Whose Pregnancy Resulted in a Live Birth|Each participant was followed until delivery to record if the outcome of the pregnancy was a live birth. Live births were defined as the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord had been cut or the placenta was attached.|At delivery|All participants for whom the status of the infant at delivery was reported are included in the analysis.|||participants|||Number
1252993|NCT00486863|Primary|Mean Newborn Birth Weight|Birth weight was collected for live infants at the time of delivery by a trained midwife, or within 24 hours of delivery for participants who chose to deliver at home with a helot, a birth attendant without formal training.|Within 24 hours of delivery.|All newborns for whom birth weights were reported were included in the analysis.|||kilograms||Standard Deviation|Mean
1252994|NCT00486837|Secondary|Change in Neutrophil Number in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 21 out of 28 subjects had applicable data to analyze. For Group 2, only 22 out of 28 subjects had applicable data to analyze.|||percentage of change||Standard Deviation|Mean
1252995|NCT00486837|Secondary|Change in Pseudomonas Load in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, all 28 subjects had applicable data to analyze.|||CFU/g||Standard Deviation|Mean
1252996|NCT00486837|Secondary|Change in Total Bacterial Load in Induced Sputum From Baseline to Week 4||Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, all 28 subjects had applicable data to analyze.|||CFU/g||Standard Deviation|Mean
1252997|NCT00486837|Secondary|Change in Total Immunoglobulin G (IgG) Fragments in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, only 26 out of 28 subjects had applicable data to analyze.|||ug/mL||Standard Deviation|Mean
1252998|NCT00486837|Secondary|Change in Alpha-1-anti-trypsin (A1AT) Activity in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, only 27 out of 28 subjects had applicable data to analyze.|||ug/mL||Standard Deviation|Mean
1252999|NCT00486837|Primary|Change in Free Elastase in Induced Sputum From Baseline to Week 4||Baseline vs Week 4|Modified Intent-to-Treat Population (mITT) was all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (free elastase in induced sputum) post baseline and at baseline (Visit 2).|||ug/mL||Standard Deviation|Mean
1253000|NCT00486824|Secondary|Time to Uterine Quiescence|Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days.|Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||days||Inter-Quartile Range|Median
1253001|NCT00486824|Secondary|Count of Participants With Side-effect Due to the Medication|Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash.|Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||Participants|||Count of Participants
1253002|NCT00486824|Secondary|Count of Participants With Neonatal Morbidity|Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.|Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||Participants|||Count of Participants
1253003|NCT00486824|Secondary|Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery||Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||days||Inter-Quartile Range|Median
1253004|NCT00486824|Secondary|Gestational Age at Delivery||Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||weeks||Inter-Quartile Range|Median
1253005|NCT00486824|Secondary|Neonatal Birthweight|Birthweight is presented in grams|Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||grams||Inter-Quartile Range|Median
1253006|NCT00486824|Primary|Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization|Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy.|Two weeks after enrolled and randomized, up to 37 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||Participants|||Count of Participants
1253007|NCT00486811|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses are rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation."|Change from Baseline to Week 12 of the Maintenance Period|Safety Set|||Units on a scale||Standard Deviation|Mean
1253008|NCT00486811|Secondary|Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire)|"The Sleep Questionnaire addressed the following question: Please rate the overall quality of your sleep last night? The quality of sleep at baseline and prior to completion of treatment are reported. The participant can choose one of the following options: Excellent, good, fair and poor."|Week 12 of the maintenance period compared to baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number of participants reporting the appropriate sleep quality category are shown.|||participants|||Number
1253009|NCT00486811|Secondary|Sleep Questionnaire: Number of Awakenings During Sleep|"The Sleep Questionnaire addressed the following question: How many times did you wake up during the night?. Sleep was assessed by the subject once a week during the entire double-blind treatment period. Reported are the baseline and end of maintenance period. Generally the less the number of awakenings the better the sleep."|Week 12 of the maintenance period compared with baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number reflects the number of participants that had the specified awakenings.|||participants|||Number
1253010|NCT00486811|Secondary|Sleep Questionnaire: Amount of Time Slept in Hours|"The Sleep Questionnaire addressed the following question: How long did you sleep last night?. The mean change for the number of hours slept during the night before from baseline to 12 weeks was studied."|Baseline to Week 12 of the maintenance period|Intention to treat (ITT). Last Observation Carried Forward (LOCF)|||hours||Standard Deviation|Mean
1253011|NCT00486811|Secondary|Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period.|"The Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night(hours)?. The mean change from baseline to 12 weeks was studied. Decrease in time, measured in hours, indicates an improvement."|Week 12 of the maintenance period compared to baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF).|||hours||Standard Deviation|Mean
1253012|NCT00486811|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Comparison of Baseline to Week 12 of the Maintenance Period|Intention to treat (ITT). Last Observation Carried Forward (LOCF).|||Index value||Standard Error|Mean
1253013|NCT00486811|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.|Change From Baseline to Week 12 of the Maintenance Period|The number indicate the available responses. For certain categories, e.g. Physical Functioning only 318 participants in the tapentadol treatment were analyzed and in the General Health analysis only 328 oxycodone- and 336 placebo-treated participants were available. Intention to treat (ITT). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Least Squares Mean
1253014|NCT00486811|Secondary|Time to Treatment Discontinuation Due to Lack of Efficacy|The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint.|Baseline to week 12 of the maintenance period|Intention to treat (ITT) The results for median and interquartile ranges were not estimated as an insufficient number of participants discontinued due to lack of efficacy to estimate values.|||days|||Number
1253015|NCT00486811|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12|Change from baseline to week 12 of Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) from 0 to 4. Higher scores indicate that a symptom is bothersome and physically disabling.|Change from baseline to week 12 of the maintenance period|Intention to treat (ITT). No imputation performed.|||units on a scale||Standard Deviation|Mean
1253016|NCT00486811|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of 12 week maintenance period|Intention to treat (ITT). Last observation carried forward (LOCF). Assessments obtained more than one day after end of treatment were not included in the analysis.|||participants|||Number
1253017|NCT00486811|Secondary|Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.|"The twice daily pain assessments were averaged. The participants were to indicate their pain on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain intensity."|Change from Baseline to Week 12 of the Maintenance Period|Intention to treat (ITT). Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1253063|NCT00486278|Secondary|Cessation of Bleeding: Number of Doses Needed to Control Bleeding||Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)|All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 1 subject did not contribute to the data.|||bleeding episodes|||Number
1253018|NCT00486811|Primary|Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS).|"For this twice daily pain assessment, the participants were required to indicate the level of pain experienced over the previous 12 hours on an 11-point Numeric Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain in the treatment group. Negative values indicate a reduction in pain."|Change from baseline over the 12 week Maintenance Period|Intent-to-treat (ITT), Last Observation Carried Forward (LOCF)|||Units on a scale||Standard Deviation|Mean
1253019|NCT00486759|Secondary|Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma|OR = a complete response (CR), an unconfirmed CR, or a partial response (PR). CR = Complete disappearance of disease and disease-related symptoms. All lymph nodes and nodal masses regressed on computed tomography (CT) to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical examination, normal size by imaging, and disappearance of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new sites of disease.|At the end of treatment (Cycle 8, up to 12 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.|||Percentage of patients|||Number
1253020|NCT00486759|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Baseline to end of the study (up to 4 years, 4 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.|||Months||Inter-Quartile Range|Median
1253021|NCT00486759|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of disease progression (PD)/relapse, as determined by the investigator, or death from any cause, whichever occurred earlier. A patient with PD/relapse must meet at least 1 of the following criteria: (1) Appearance of any new lesion > 1.0 cm in the short axis during or at the end of therapy. (2) ≥ 50 % increase from nadir in the sum of the products of diameters (SPD, maximum diameter of a tumor x largest diameter perpendicular to the maximum diameter) of any previously involved nodes, in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis < 1.0 cm must increase by ≥ 50% to a size of 1.5 x 1.5 cm or > 1.5 cm in the long axis. (3) ≥ 50 % increase in the greatest diameter of any previously identified node > 1.0 cm in its short axis or in the SPD of more than 1 node.|Baseline to end of the study (up to 4 years, 4 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.|||Months||Inter-Quartile Range|Median
1253022|NCT00486720|Primary|Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.||Every 21 days while on therapy and at 30 days after the last dose of study therapy||||Participants|||Number
1253023|NCT00486720|Primary|Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria|Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.|2 Years|Full analysis set (FAS) population is the analysis population. This population consists of all randomized patients who have received at least one dose of study medication.|||Participants|||Number
1253024|NCT00486642|Other Pre-specified|Survival Rate|Calculated by Kaplan and Meier.|At 1 year|Very little death information is captured for this study so OS analysis was not done.||||||
1253025|NCT00486642|Other Pre-specified|Median Survival Time|Calculated by Kaplan and Meier|Up to 1 year after completion of treatment|Very little death information is captured for this study so OS analysis was not done.||||||
1253026|NCT00486642|Secondary|Toxicity|Patients who came off treatment due to toxicity.|Assessed up to 5 years||||participants|||Number
1253027|NCT00486642|Secondary|Time to Disease Progression|Earliest date on which disease progression was determined by any of the methods listed: PSA progression, objective disease progression (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer-related symptomatic progression.|Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 years||||months||95% Confidence Interval|Median
1253028|NCT00486642|Secondary|Stable Disease Rate as Assessed by RECIST Criteria|RECIST Stable defined as - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Measured from the start of the treatment until the criteria for progression are met or death from any cause, whichever came first, assessed up to 5 years|5 evaluable patients in Arm A + 9 evaluable patients in Arm B|||Participants|||Count of Participants
1253029|NCT00486642|Secondary|Median Duration of PSA-Response|"Definition of PSA response: >= 50% fall (minimum 5 ng/ml) in PSA from baseline maintained for >4 weeks, and without other evidence of disease progression documented at time of confirmatory values.~PSA response duration will commence on the date of the first >=50% decline in PSA. The response duration ends when PSA progression criteria are met with the second increasing PSA value.~PSA progression in PSA responders: rise in PSA of 50% (minimum 5ng/ml) above nadir value and confirmed by a second increasing value at least 1 week later."|From time PSA response criteria are met until time PSA progression criteria are met or death from any cause, whichever came first, up to 5 years|1 patient in Arm A and 2 patients in Arm B had a PSA response.|||months||Full Range|Median
1253390|NCT00483119|Secondary|Toxicity of Treatment: Measured in Renal Toxicity, Myelosuppression or Hepatic Toxicity||Throughout course of study|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.||||||
1253030|NCT00486642|Secondary|Progression-free Survival|"PFS is defined as the time from treatment initiation to disease progression or death from any cause, whichever came first.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|From time of treatment initiation to disease progression or death from any cause, whichever came first, assessed up to 5 years||||months||95% Confidence Interval|Median
1253031|NCT00486642|Secondary|Objective Tumor Response Rate as Assessed by RECIST Criteria|RECIST PR defined as - At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 years|5 evaluable patients in Arm A + 9 evaluable patients in Arm B|||patient|||Number
1253032|NCT00486642|Primary|PSA Response Rate|Prostate-specific antigen (PSA) response rate (defined as a confirmed > / = 50% decline (minimum 5ng/ml) in PSA from baseline maintained for >4 weeks, and without other evidence of disease progression documented at time of confirmatory values).|Up to 12 weeks|9 evaluable in Arm A + 12 evaluable in Arm B|||Participants|||Count of Participants
1253033|NCT00486525|Primary|CES-D|"The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||units on a scale||Standard Error|Least Squares Mean
1253034|NCT00486525|Primary|Vitality, SF-36|"The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month.~Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||units on a scale||Standard Error|Least Squares Mean
1253035|NCT00486525|Primary|MFSI-SF Fatigue|"The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue.~Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||units on a scale||Standard Error|Least Squares Mean
1253036|NCT00486525|Primary|Stimulated ln (IL-1b)|log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||ln (pg/mL)||Standard Error|Least Squares Mean
1253037|NCT00486525|Primary|Stimulated ln (IL-6)|log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||ln (pg/mL)||Standard Error|Least Squares Mean
1253038|NCT00486525|Primary|Stimulated ln (TNF-a)|log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||ln (pg/mL)||Standard Error|Least Squares Mean
1253039|NCT00486447|Secondary|Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).||1 year outcomes after initial MPS exam|Data were not collected for analysis.||||||
1253040|NCT00486447|Primary|Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.|Number of subjects with CT for detection purposes|through study completion, an expected average of 1 year|Data were not collected for analysis.||||||
1253041|NCT00486434|Primary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolut change from baseline to 24 months. If the outcome is less that 0 there is improvement (less diffulty).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||Units on a scale||Inter-Quartile Range|Median
1253042|NCT00486434|Primary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolut change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||Units on a scale||Inter-Quartile Range|Median
1253043|NCT00486434|Secondary|Changes in Biochemical Markers of Bone & Cartilage Metabolism.Effect on Hand OA Assessed by X-ray & Questionnaire at Baseline and After 24 Months.Disease Progression in the Knee Evaluated by MRI.Nature and # of AEs Monitored Continuously During Study||January 2010|||||||
1263171|NCT00411151|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|one year|Safety population comprises all patients registered.|||Participants|||Number
1253044|NCT00486434|Primary|Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criterias. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criterias were met. The outcome was meassured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||mm||Standard Deviation|Mean
1253045|NCT00486330|Primary|Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)|Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs.|10 days||||h*ng/mL||Full Range|Geometric Mean
1253046|NCT00486291|Secondary|Absolute Weight Change (kg) From Baseline to Week 28||Baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||kg||Standard Error|Least Squares Mean
1253047|NCT00486291|Primary|Change From Baseline in HbA1c at Week 28.||Baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
1253048|NCT00486278|Secondary|Haematology: Platelet Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||10^9 cells/L||Standard Deviation|Mean
1253049|NCT00486278|Secondary|Haematology: White Cell Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||10^9 cells/L||Standard Deviation|Mean
1253050|NCT00486278|Secondary|Haematology: Packed Cell Volume||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||percentage (%)||Standard Deviation|Mean
1253051|NCT00486278|Secondary|Haematology: Red Cell Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||10^12 cells/L||Standard Deviation|Mean
1253052|NCT00486278|Secondary|Haematology: Haemoglobin||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||g/dL||Standard Deviation|Mean
1253053|NCT00486278|Secondary|Biochemistry: Creatinine||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||micromol/L||Standard Deviation|Mean
1253054|NCT00486278|Secondary|Biochemistry: ALAT (Alanine Aminotransferase)||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||U/L||Standard Deviation|Mean
1253055|NCT00486278|Secondary|Immunogenicity (Inhibitor Development)|Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or rFVIIa.|Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||participants|||Number
1253056|NCT00486278|Secondary|Pharmakokinetic Parameters Based on FVIIa Activity: Vss (Distribution Volume at Steady State)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||mL/kg||Full Range|Median
1253057|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: CL (Total Clearance)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||mL/h||Full Range|Median
1253058|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: t½ (Terminal Half-life)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||hours||Standard Deviation|Mean
1253059|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||hours||Standard Deviation|Mean
1253060|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
1253061|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) )||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
1268551|NCT00371787|Primary|Visual Acuity|level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.|9 month||||logMAR||Standard Deviation|Mean
1253064|NCT00486278|Secondary|Activated Partial Thromboplastin Time (aPTT)|The aPTT time measured in clinical samples reflects both the effect of the drugs (generation of thrombin and FXa) and the presence of rFVIIa /rFVIIa analogue in the plasma samples causing a dose dependent shortening of the clotting time.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||Sec||Standard Deviation|Mean
1253065|NCT00486278|Secondary|F1 + 2 (Prothrombin Fragments 1+2)|Thrombin and F1+2 are formed in equimolar quantities by the enzymatic cleavage of prothrombin (FII), and F1+2 thus indicate that thrombin has been generated.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||pmol/L||Standard Deviation|Mean
1253066|NCT00486278|Secondary|Prothrombin Time (PT)|The test measures the clotting time of plasma following the activation of tissue factor (TF also called thromboplastin) and calcium to hypocalcemic plasma. PT was provided in percent based on the measured PT in seconds and related/converted with the relevant standard curve. The percent value was derived based on the hyperbolic relation between PT (sec) and % PT activity.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||percentage (%)||Standard Deviation|Mean
1253067|NCT00486278|Secondary|Activated Recombinant Human Factor VII Analogue Activity in the Blood||0-24 hours after trial product administration|All randomised patients in top three dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violation of the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set.|||IU/mL||Standard Deviation|Mean
1253068|NCT00486278|Primary|Number of Adverse Events (AEs)|Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1253069|NCT00486265|Secondary|To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs||Patients were followed for safety from the date of first dose of AZD4877 up to 30-days after the last administration of AZD4877, where possible.|||||||
1253070|NCT00486265|Secondary|To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR)|Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.|Response is evaluated after a maximum of 2 courses of induction therapy.|||||||
1253071|NCT00486265|Primary|To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]|Maximum plasma concentration, Cmax|PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8.|||||||
1253072|NCT00486265|Primary|To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)|Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.|Response is evaluated after a maximum of 2 courses of induction therapy.|8 of 9 patients in Part B were evaluable for response following a maximum of 2 courses of induction therapy.|||Participants|||Number
1253073|NCT00486265|Primary|To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs)|To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)|Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period.|||||||
1253074|NCT00486252|Other Pre-specified|Change in Intraocular Presssure (IOP): Baseline to Month 1|Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.|Baseline, Month 1|Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.|||mmHg||Standard Deviation|Mean
1253075|NCT00486252|Secondary|Categorized Percentage Change in Intraocular Pressure (IOP)|Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change < 0); Percentage reduction greater than 20% (percentage change < -20).|Month 1, Month 3|"Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category."|||participants|||Number
1253076|NCT00486252|Secondary|Percentage Change in Intraocular Pressure (IOP)|Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.|Month 1, Month 3|Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.|||percentage change in mmHg||Standard Deviation|Mean
1253094|NCT00486018|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months|BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.|||Units on a scale||Standard Deviation|Mean
1253095|NCT00485953|Secondary|Markers of Bone Resorption and Bone Formation||at 24 months||||percentage change||Standard Error|Mean
1253077|NCT00486252|Primary|Change in Intraocular Pressure (IOP): Baseline to Month 3|Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.|Baseline, Month 3|"Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category."|||mmHg||Standard Deviation|Mean
1253078|NCT00486226|Secondary|Aneurysm Occlusion|Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)|post procedure to 6 months|no data was available for 21 subjects post-procedure and 26 subjects at 6 months follow-up; either because the investigator didn't submit the images or due to poor quality of the submitted images|||participants|||Number
1253079|NCT00486226|Secondary|Satisfactory Coil Mass Position|Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically|6 months|no data was available for 33 subjects; either because the investigator didn't submit the images or due to poor quality of the submitted images|||participants|||Number
1253080|NCT00486226|Secondary|Device or Procedure Related Adverse Events (AEs)|Incidence of device or procedure related adverse events during the index procedure and till discharge|index procedure to discharge; an average of 3.8 days||||participants|||Number
1253081|NCT00486226|Primary|The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)|Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically|Intra-procedure||||participants||95% Confidence Interval|Number
1253082|NCT00486044|Secondary|Changes in Cognitive Performance|"Change in Hopkins Verbal Learning Test Delayed Recall~The Hopkins Verbal Learning Test Delayed Recall score is the raw number of words recalled at Trial 4, adjusted for years of education and age. This is a 12-item word list test."|Baseline and 9 months|1 participant in simvastatin arm with missing data|||adjusted words recalled||Standard Deviation|Mean
1253083|NCT00486044|Secondary|Change in Inflammatory Markers|Change noted in serum high-sensitivity c-reactive protein|baseline and 9 months|2 participants in the simvastatin arm and 3 participants in the placebo arm had incomplete hs-CRP results|||mg/L||Standard Deviation|Mean
1253084|NCT00486044|Secondary|Changes in Regional Cerebral Blood Flow on MRI|Mean changes noted in posterior cingulate cortex|baseline and 9 months|Number of participants analyzed represent participants in MRI substudy with readable MRI scans at both baseline and 9 months; 24 and 17 readable MRI scans in simvastatin and placebo arms, respectively. Unusable MRI scans resulted from poor quality images due to technical problems.|||mL/100 g/min||Standard Deviation|Mean
1253085|NCT00486044|Primary|Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42||baseline and 9 months|1 participant declined follow up CSF collection in simvastatin arm; CSF could not be accessed at month 9 in 1 participant in placebo arm|||ng/L||Standard Deviation|Mean
1253086|NCT00486031|Secondary|Time to Onset of AEs|Time to onset of adverse events|24 Months|||||||
1253087|NCT00486031|Primary|Incidence of AE and SAE,Relationship to Study Medication, and Severity|Incidence of adverse events and serious adverse events,relationship to study medication, and severity|24 Months||||Subjects wiath any TEAE|||Number
1253088|NCT00486018|Secondary|Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.|||Points on the NEI-VFQ-25 subscale||Standard Deviation|Mean
1253089|NCT00486018|Secondary|Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.|||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
1253090|NCT00486018|Secondary|Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6|A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||μm||Standard Deviation|Mean
1253091|NCT00486018|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6|A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.|6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1253092|NCT00486018|Secondary|Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost <15 letters will be greater than the percentage of subjects who “gained >=15 letters” as “losing <15 letters” includes both those who gained >=15 letters and those who were “stable” (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters).|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1253093|NCT00486018|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1253098|NCT00485836|Secondary|Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.|||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
1253099|NCT00485836|Secondary|Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.|||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
1253100|NCT00485836|Secondary|Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6|A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||μm||Standard Deviation|Mean
1253101|NCT00485836|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6|A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.|6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1253102|NCT00485836|Secondary|Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1253103|NCT00485836|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1253104|NCT00485836|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months|BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.|||Units on a scale||Standard Deviation|Mean
1253105|NCT00485758|Secondary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo|after 12 weeks of treatment, to assess the reduction of triglycerides in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set With at Least one Post-Titration Visit Measurement|||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Median
1253106|NCT00485758|Secondary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo|After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set|||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Least Squares Mean
1253107|NCT00485758|Primary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo|After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set|||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Least Squares Mean
1253108|NCT00485732|Secondary|Number of Subjects With Pregnancies and Their Outcome|Total: the total number of pregnancies in a group. The specific outcomes are also listed.|from Day 0 up to Month 7|Analysis was performed on subjects with a pregnancy.|||Participants|||Count of Participants
1253109|NCT00485732|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7||||Participants|||Count of Participants
1253110|NCT00485732|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses.|From Day 0 up to Month 7||||Participants|||Count of Participants
1253111|NCT00485732|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day (Days 0-29) period following each vaccination||||Participants|||Count of Participants
1253112|NCT00485732|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.|||Participants|||Count of Participants
1253113|NCT00485732|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.|||Participants|||Count of Participants
1263172|NCT00411151|Secondary|Adverse Events|The number of participants with at least one adverse event was measured.|one year|Safety population comprises all patients registered.|||Participants|||Number
1253115|NCT00485732|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|One month post Dose 3 (Month 7)|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for immunogenicity.|||Participants|||Count of Participants
1253116|NCT00485693|Secondary|Number of Participants With Adverse Events or Serious Adverse Events Through 30 Days||Up to 30 days|||||||
1253117|NCT00485693|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4|The subject’s pain intensity was to be assessed with activity (NRS-A) after actively flexing the involved knee to the maximum flexion point possible. The subject was asked to respond to the following question: “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?”|0 to 96 hours||||Units on a scale*hours||Standard Deviation|Mean
1253118|NCT00485485|Primary|Participant Response Rate|Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.|At 6 weeks reconfirmed 6 weeks later||||Participants|||Number
1253119|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score).|Total Mood Disturbance score sums up over the domain scores regarding Tension-anxiety, Depression-ejection, Anger-hostility, Vigor-activity (was subtracted), Fatigue-inertia, Confusion-bewilderment. Domain scores were derived as sum of the respective items and range from 0 to 20. With exception of Vigor-activity high values describe bad mood.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included.|||Unit on a scale||Standard Deviation|Mean
1253120|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject’s Sleep.|Pain interference with sleep refers to patient's last evening prior to the visit and was assessed using a 100mm visual analog scale (VAS). The VAS ranges from 0 (did not interfere) to 100 (completely interfered).|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included.|||Unit on a scale||Standard Deviation|Mean
1253121|NCT00485472|Secondary|Amount of Rescue Medication Use During 8 Week Maintenance Period.|Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day.|during 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects who entered the Maintenance Phase were included.|||tablets/day||Standard Deviation|Mean
1253122|NCT00485472|Secondary|Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).|Improvement = reduction of >= 20% and >= 10 mm in both WOMAC pain and physical function subscale. Those who met the criteria in either of the subscales had improved if response to Patient's Global Impression of change from baseline was at least 'mildly improved'. High improvement = reduction of >= 50% and >= 20 mm in either of the subscales. Response = either high improvement or improvement.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Dropouts due to lack of efficay were defined as non-responders. For dropouts due to any other reason LOCF was applied to the underlying WOMAC subscale scores.|||participants|||Number
1253123|NCT00485472|Secondary|Patient’s Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.|Patient's global impression of change from baseline is a score that ranges from 'very much worse' to 'very much improved'.|at the end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing measurements of Patient's global impression of change from baseline were included.|||Participants|||Number
1253124|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.|The WOMAC total score is the sum of the normalized subscale scores for pain, stiffness, and physical function and ranges from 0 to 300, high values describe high grade of impact.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.|||Unit on a scale||Standard Deviation|Mean
1253125|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.|The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.|||Unit on a scale||Standard Deviation|Mean
1253126|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.|The WOMAC physical function subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of difficulty in performing daily activities.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.|||Unit on a scale||Standard Deviation|Mean
1253391|NCT00483119|Primary|Serum Levels of Pemphigus Antibodies||6-10 weeks after initiation of therapy|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.||||||
1253127|NCT00485472|Primary|Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period|The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Last observation carried forward (LOCF) imputation method was applied in case of missing WOMAC assessment.|||Unit on a scale||Standard Deviation|Mean
1253128|NCT00485433|Secondary|Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days||Up to 30 days|||||||
1253129|NCT00485433|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours|The subject’s pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?”|0 to 72 hours||||Units on a scale*hours||Standard Deviation|Mean
1253130|NCT00485303|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||percentage of participants|||Number
1253131|NCT00485303|Secondary|Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score|ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.|Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. 'N' (number of participants analyzed) = participants who were evaluable for this measure.|||participants|||Number
1253132|NCT00485303|Secondary|Time to Radiographic Progression|Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||days||95% Confidence Interval|Median
1253133|NCT00485303|Secondary|Time to PSA Progression|The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.|Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||days||95% Confidence Interval|Median
1253134|NCT00485303|Secondary|Percentage of Participants With Objective Radiographic Response|Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least 1 dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. “N” (number of participants analyzed) =participants who were evaluable for this measure.|||percentage of participants|||Number
1253135|NCT00485303|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.|Every 3 months until death or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||days||95% Confidence Interval|Median
1253136|NCT00485303|Secondary|Radiographic Progression Free Survival (PFS)|The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months||||days||95% Confidence Interval|Median
1253148|NCT00485264|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear-log trapezoidal rule.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).|||hour*mg/L||Standard Deviation|Mean
1253137|NCT00485303|Secondary|Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)|The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.|Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||days||95% Confidence Interval|Median
1253138|NCT00485303|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.|Day 1 of each cycle (of 28 days each) up to Cycle 12|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||percentage of participants||95% Confidence Interval|Number
1253139|NCT00485264|Secondary|Change of CD4 Percent From Baseline|Change in CD4 percent from baseline was calculated as the value of the later visit minus the value at baseline.|Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||percentage of total lymphocytes||95% Confidence Interval|Mean
1253140|NCT00485264|Secondary|Change of CD4 Count From Baseline|Change in CD4 cell count from baseline was calculated as the value at later visit minus the value at baseline.|Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||cells/µL||95% Confidence Interval|Mean
1253141|NCT00485264|Secondary|Percentage of Participants With ≥1 log10 Drop From Baseline in HIV RNA or HIV RNA <400 Copies/mL|Plasma HIV RNA concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular), and analyses used the Observed Failure Approach.|Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||percentage of participants||95% Confidence Interval|Number
1253142|NCT00485264|Secondary|Number of Participants Who Died|Number of participants who died were summarized.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||participants|||Number
1253143|NCT00485264|Secondary|Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication|The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||participants|||Number
1253144|NCT00485264|Secondary|Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)|Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||percentage of participants||95% Confidence Interval|Number
1253145|NCT00485264|Primary|PK Parameter: Concentration at 12 Hours Postdose (C12h)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Plasma concentration at 12 hours postdose (C12h) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).|||ng/mL||Standard Deviation|Mean
1253146|NCT00485264|Primary|PK Parameter: Time to Half of Maximum Plasma Concentration Cmax (T1/2)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Time to half of maximum plasma concentration Cmax (T1/2) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).|||hour||Standard Deviation|Mean
1253147|NCT00485264|Primary|PK Parameter: Maximum Plasma Concentration (Cmax)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Maximum plasma concentration (Cmax) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).|||ng/mL||Standard Deviation|Mean
1272335|NCT00336700|Primary|1-year Recurrence Free Survival (RFS)||Up to 60 months||||percentage of participants||95% Confidence Interval|Number
1253149|NCT00485264|Primary|Number of Participants Who Died|Number of participants who died were summarized.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||participants|||Number
1253150|NCT00485264|Primary|Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication|The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||participants|||Number
1253151|NCT00485264|Primary|Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)|Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||percentage of participants||95% Confidence Interval|Number
1253152|NCT00485173|Other Pre-specified|Ossification in the Region of Target Level|Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
1253153|NCT00485173|Secondary|Number of Patients Who Had Secondary Surgeries at the Index Level|Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.|24 months post-operation||||participants|||Number
1253154|NCT00485173|Secondary|Hospital Stay||During the time of hospital stay, average of 1 day.|Primary dataset.|||days||Standard Deviation|Mean
1253155|NCT00485173|Secondary|Blood Loss||During the time of operation, approximately 1.5 hours.|Primary dataset.|||ml||Standard Deviation|Mean
1253156|NCT00485173|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, approximately 1.5 hrs.|Primary dataset.|||hrs||Standard Deviation|Mean
1253157|NCT00485173|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
1253158|NCT00485173|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
1253159|NCT00485173|Other Pre-specified|General Health Status -- SF-36 MCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
1253160|NCT00485173|Secondary|Arm Pain Success Rate|Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
1253161|NCT00485173|Other Pre-specified|General Health Status -- SF-36 PCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
1253162|NCT00485173|Secondary|Neck Pain Success Rate|Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
1253163|NCT00485173|Other Pre-specified|Arm Pain Score|"Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score will be the sum of pain intensity and frequency scores."|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
1253164|NCT00485173|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
1253165|NCT00485173|Other Pre-specified|Neck Pain Score|"Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score is the sum of pain intensity and frequency scores."|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
1253167|NCT00485173|Other Pre-specified|Neck Disability Index Score|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
1253168|NCT00485173|Secondary|Success Rate of Fusion|"Success Rate of Fusion is reported as percent of participants who met the following fusion criteria:~Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer.~No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.~No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs)."|24 months post-operation|Primary dataset.|||percentage of participants|||Number
1253169|NCT00485173|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~fusion at the treated level;~pain/disability (Neck Disability Index) success;~neurological status success;~no serious adverse event classified as “implant associated” or “implant/surgical procedure associated;”~no additional surgical procedure classified as a “failure.”"|24 months post-operation|Primary dataset (including all subjects who received study devices. Missing observations were not imputed.)|||percentage of participants|||Number
1253170|NCT00485134|Secondary|Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/or LPS|Immune responder is defined as someone with both a serologic and an ASC response to either Invaplex 50 or LPS. Immune response defined as Serology: ≥ 4-fold increase in baseline serum titer antibody cecreting cells (ASC): ≥ 10 ASC per 106 peripheral blood mononuclear cells(PBMC).|56 days post-vaccination in stage 1|This analysis is limited to groups A-C only and subjects receiving at least 2 doses of S. flexneri 2a Invaplex 50 or LPS|||participants|||Number
1253171|NCT00485134|Secondary|S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group||56 days post-challenge||||participants|||Number
1253172|NCT00485134|Secondary|Post-challenge Loose Stool Sample Durations by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.|||hours||Full Range|Mean
1253173|NCT00485134|Secondary|Post-challenge Loose Stool Sample Volumes by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.|||mL||Full Range|Mean
1253174|NCT00485134|Secondary|Post-challenge Loose Stool Samples Occurrences by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.|||loose stools||Full Range|Mean
1253175|NCT00485134|Primary|Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group|Fecal samples were collected through day 77 or until discharge (all stools collected for weighing/grading; maximum of 3 stools/day for culture; rectal swab obtained if no stool provided).|7 days after challenge|The decision criteria to progress to challenge with the Shigella challenge strain were no limiting adverse events (AEs) and positive immune response. These individuals were challenged with 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.|||participants|||Number
1253176|NCT00485069|Secondary|"Mean Change From Baseline in Awake Time Off (Hours) and Awake Time On (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With 0 Off (Hour) at Baseline"|"Off state is where PD symptoms are not adequately controlled by the drug. On state is where PD symptoms are well controlled by the drug. The off’s duration (awake time spent off) and the on’s duration (awake time spent on) on each day were calculated."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants having off hour of zero at baseline were not included at FAP. These participants as well as those prematurely withdrawn from the study were not included at Week 52."|||hours||Standard Deviation|Mean
1253177|NCT00485069|Secondary|Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP|"CGI is measured on the following 7-point scale: 1, Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; and 7, Very much worse. Responders are defined as those participants scored as very much improved or much improved."|Week 52 and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||participants|||Number
1253178|NCT00485069|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.|Days 0-419|FAS|||percentage of participants|||Number
1253179|NCT00485069|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.|Days 0-422|FAS|||percentage of participants|||Number
1253180|NCT00485069|Secondary|Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group|The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.|||percent change||Standard Deviation|Mean
1253220|NCT00484419|Secondary|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16|mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||uIU/mL||Standard Deviation|Mean
1253181|NCT00485069|Secondary|"Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in on state, not having off state at baseline in off state, or having no data in the corresponding state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52."|||percent change||Standard Deviation|Mean
1253182|NCT00485069|Secondary|Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group|The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided.|Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.|||participants|||Number
1253183|NCT00485069|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by On/Off State in the ROP+L-Dopa Group"|The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. LOCF was used for the FAP data to impute post-baseline missing values. Some participants in each state were not included at FAP as having no post-baseline data in the corresponding state or having no data in the corresponding state at Week 52/withdrawal.|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants without off state at baseline were not included in the analysis of baseline off state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52."|||participants|||Number
1253184|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn from the study were not included at Week 52.|||percent change in score||Standard Deviation|Mean
1253185|NCT00485069|Secondary|Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||units on a scale||Standard Deviation|Mean
1253186|NCT00485069|Secondary|"Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in On State for the ROP+L-Dopa Group) at Week 52 and FAP"|"The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants with off state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with off state at Week 52 in that group and those prematurely withdrawn in each group were not included at Week 52."|||percent change in score||Standard Deviation|Mean
1253187|NCT00485069|Secondary|"Japanese UPDRS Part III Mean Total Score (in On State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP"|"The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants having off state at baseline were not included in the ROP+L-dopa group at baseline. The participant not included in the FAP as well as one having off state in the ROP+L-dopa group at Week 52 and those prematurely withdrawn in each group were not included at Week 52."|||units on a scale||Standard Deviation|Mean
1253221|NCT00484419|Secondary|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8|mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||uIU/mL||Standard Deviation|Mean
1253224|NCT00484419|Secondary|Mean Change in FPG From Week 0(Baseline) to Week 16|change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||Standard Deviation|Mean
1253188|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change. These participants as well as those prematurely withdrawn were not included at Week 52|||percent change in score||Standard Deviation|Mean
1253189|NCT00485069|Secondary|"Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for FAP data. Some participants were not included at FAP as having a baseline value of zero, having no post-baseline data in on state, not having off state at baseline in off state, or having no data at Week 52/withdrawal in off state. These participants as well as those prematurely withdrawn were not included at Week 52."|||percent change in score||Standard Deviation|Mean
1253190|NCT00485069|Secondary|Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.|||units on a scale||Standard Deviation|Mean
1253191|NCT00485069|Secondary|"Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in on state or having no data in off state at Week 52/withdrawal."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants without off state at baseline were not included in the analysis of baseline off state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52."|||units on a scale||Standard Deviation|Mean
1253192|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn in each group were not included at Week 52.|||percent change in score||Standard Deviation|Mean
1253193|NCT00485069|Secondary|Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||units on a scale||Standard Deviation|Mean
1253194|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||units on a scale||Standard Deviation|Mean
1253195|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.|||units on a scale||Standard Deviation|Mean
1253222|NCT00484419|Secondary|Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean|change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||uIU/mL||95% Confidence Interval|Least Squares Mean
1253196|NCT00485069|Secondary|"Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having no post-baseline data in on state, not having off state at baseline, or no data in off state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52."|||units on a scale||Standard Deviation|Mean
1253197|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||units on a scale||Standard Deviation|Mean
1253198|NCT00485069|Primary|"Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in On State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)"|"The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Participants with off state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with off state at Week 52 and those prematurely withdrawn were not included at Week 52."|Baseline, Week 52, and FAP (up to Week 52)|Full Analysis Set (FAS): all participants enrolled in the Treatment Phase, excluding those with objective measurements not meeting the major eligibility criteria, who did not receive ROP at all, and those with no valid post-baseline data. Last observation carried forward (LOCF) was used for the FAP data to impute post-baseline missing values.|||units on a scale||Standard Deviation|Mean
1253199|NCT00484939|Secondary|AEs, Laboratory Parameters, Vital Signs||Throughout study|||||||
1253200|NCT00484939|Secondary|Duration of Follow-up|Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Days||Standard Deviation|Mean
1253201|NCT00484939|Secondary|Percentage of Participants Requiring Additional Treatment for Malignancy|Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Percentage of participants|||Number
1253202|NCT00484939|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.|Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).|Intent-to-treat population: All participants randomized into the study.|||Percentage of participants|||Number
1253203|NCT00484939|Secondary|Overall Survival|Overall survival was defined as the time in months from randomization to death from any cause.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Months||95% Confidence Interval|Median
1253204|NCT00484939|Secondary|Time to Response|Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Months||95% Confidence Interval|Median
1253205|NCT00484939|Secondary|Duration of Response|Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study. Only participants with a complete response or partial response were included in the analysis.|||Months||95% Confidence Interval|Median
1253223|NCT00484419|Secondary|Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean|change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||uIU/mL||95% Confidence Interval|Least Squares Mean
1253206|NCT00484939|Secondary|Best Overall Response (BOR)|BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study. Only participants with a response were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1253207|NCT00484939|Primary|Progression-free Survival|Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Months||95% Confidence Interval|Median
1253208|NCT00484874|Secondary|Frequency of Visualization of Hodgkin's Lymphoma With I-131 Tositumomab Imaging and Tumor Radiation Absorbed Dose|Percentage of participants with visualized I-131 uptake.|up to 1 week post-intervention||||Percentage of patients with I-131 uptake|||Number
1253209|NCT00484874|Secondary|Median Time to Progression Following I-131 Tositumomab Therapy.||From time measurement criteria are met for response until first date that recurrent or progressive disease is objectively documented, assessed up to 5 years.||||weeks||Standard Deviation|Median
1253210|NCT00484874|Primary|Overall and Complete Response Rates|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CTI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|12 weeks post therapy||||percentage of participants|||Number
1253211|NCT00484874|Primary|Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma.||2 years||||cGy|||Number
1253212|NCT00484679|Primary|Mean Change in Cortisol Levels From Baseline to Week 24|Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.|baseline, week 24|Participants who completed all treatment and follow-up visits|||mg/dL||Standard Deviation|Mean
1253213|NCT00484419|Secondary|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)|percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||% change in LDL-C||95% Confidence Interval|Least Squares Mean
1253214|NCT00484419|Secondary|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16|mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||% change in LDL-C||Standard Deviation|Mean
1253215|NCT00484419|Secondary|Mean Change in LDL-C From Week 0(Baseline) to Week 16|mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||Standard Deviation|Mean
1253216|NCT00484419|Secondary|Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean|change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1253217|NCT00484419|Secondary|Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16|mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||Standard Deviation|Mean
1253218|NCT00484419|Secondary|Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16|mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||Standard Deviation|Mean
1253219|NCT00484419|Secondary|Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean|change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1253225|NCT00484419|Secondary|Mean Change in FPG From Week 0(Baseline) to Week 8|mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.||||mg/dL||Standard Deviation|Mean
1253226|NCT00484419|Secondary|Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean|change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1253227|NCT00484419|Secondary|Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean|change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1253228|NCT00484419|Primary|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint|Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||% change HbA1c||Standard Deviation|Mean
1253229|NCT00484419|Secondary|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8|change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.||||% change in HbA1c||Standard Deviation|Mean
1253230|NCT00484419|Secondary|Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean|Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||% change in HbA1c||95% Confidence Interval|Least Squares Mean
1253231|NCT00484393|Primary|To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.|Parent score 1-10 (1 representing no pain and 10 representing extreme pain) FLACC (Face, Legs, Activity, Cry, Consolability) Score 0-10 (at baseline and post injection) (0 representing no pain and 10 representing extreme pain) Change in FLACC score|2 visits, 1 month apart|Each participant was evaluated for repsonse following tetracaine and following placebo|||units on a scale||Full Range|Mean
1253232|NCT00484354|Secondary|Mortality|Number of patients who died during the hospitalization|Until hospital discharge, up to 30 days||||Participants|||Count of Participants
1253233|NCT00484354|Secondary|Number of Participants With Need for Dialysis|Number of participants needing dialysis|Until hospital discharge, up to 30 days||||Participants|||Count of Participants
1253234|NCT00484354|Secondary|Length of Hospital Stay|Length of hospital stay in days|Until hospital discharge, up to 30 days||||days||Standard Deviation|Mean
1253235|NCT00484354|Secondary|Change in GFR Over 72 Hours Post Operatively|25% or greater change in serum creatinine level|72 hours||||Participants|||Count of Participants
1253236|NCT00484354|Primary|Number of Participants Who Developed Acute Kidney Injury Within 72 Hours|Number (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline|72 hours post-operative||||Participants|||Count of Participants
1253237|NCT00484315|Secondary|In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure|The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment (“in-segment”) is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.|9 months post-index procedure|All patients from the per protocol analysis set who were randomized to the angiographic subset and completed their angiographic follow-up were analyzed for the secondary endpoint.|||percent diameter stenosis||Standard Deviation|Mean
1253238|NCT00484315|Primary|Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.|The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.|12 months post-index procedure|The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per protocol analysis set. All randomized participants who had the randomly assigned study stent implanted in the target coronary artery are included.|||participants|||Number
1253239|NCT00484289|Primary|Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator||At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.|||participants|||Number
1253240|NCT00484289|Secondary|Abatacept PK Parameter: Minimum Plasma Concentration at Steady State|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.|||µg/mL||Full Range|Median
1253241|NCT00484289|Secondary|Abatacept PK Parameter: Maximum Serum Concentration at Steady State|Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.|||µg/mL||Full Range|Median
1253242|NCT00484289|Secondary|Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State|Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.|||µg*h/mL||Full Range|Median
1263620|NCT00408681|Secondary|Recurrent or Progressive Malignancy|Recurrence or progression of the malignant disease that was the reason for hematopoietic cell transplantation|2 years after enrollment||||Participants|||Count of Participants
1253243|NCT00484289|Secondary|Abatacept PK Parameter: Total Body Clearance|Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.|||L/day||Full Range|Median
1253244|NCT00484289|Secondary|Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies|Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed.|At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.|All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity.|||participants|||Number
1253245|NCT00484289|Secondary|Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||IU/mL||95% Confidence Interval|Mean
1253246|NCT00484289|Secondary|Baseline and Postbaseline Rheumatoid Factor Levels|Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||IU/mL||Standard Deviation|Mean
1253247|NCT00484289|Secondary|Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||percentage improvement||95% Confidence Interval|Mean
1253248|NCT00484289|Secondary|Baseline and Postbaseline C-reactive Protein (CRP) Levels|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = number of participants with both BL and PBL measurement at a given point time point.|||mg/dL||Standard Deviation|Mean
1253249|NCT00484289|Secondary|Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192|The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values.|At BL (Week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||Units on a Scale||95% Confidence Interval|Mean
1253250|NCT00484289|Secondary|Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||Units on a Scale||Standard Deviation|Mean
1253251|NCT00484289|Secondary|Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192|The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values.|At baseline (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||Units on a Scale||95% Confidence Interval|Mean
1253372|NCT00483379|Secondary|Baseline Values for Left Ventricular Mass Index (LVMI)|Cardiac pathophysiology was assessed by a central cardiologist using left ventricular mass index (LVMI) measured by echocardiogram at Baseline. Left Ventricular Mass is adjusted to the participant's body surface area in the calculation of LVMI.|Day 0|Full analysis population of participants with LVMI data|||g/m^2||Full Range|Median
1253252|NCT00484289|Secondary|Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||Units on a Scale||Standard Deviation|Mean
1253253|NCT00484289|Secondary|Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.|||percentage of participants||95% Confidence Interval|Number
1253254|NCT00484289|Secondary|Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192|"The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.~Participants with DAS 28 score < 2.6 were considered to be in remission."|At weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.|||participants|||Number
1253255|NCT00484289|Secondary|Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity.|At weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.|||participants|||Number
1253256|NCT00484289|Primary|Number of Participants With Abnormal Laboratory Changes (ALC)|The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.|From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.|||participants|||Number
1253257|NCT00484289|Secondary|Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192|"The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.~Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement."|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.|||participants|||Number
1253258|NCT00484289|Secondary|Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.|||Units on a Scale||95% Confidence Interval|Mean
1253259|NCT00484289|Secondary|Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data.|At BL (week 0), week 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.|||Units on a Scale||Standard Deviation|Mean
1253260|NCT00484289|Secondary|Percentage of Participants With ACR 70 Response Over Time|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.|||percentage of participants||95% Confidence Interval|Number
1253261|NCT00484289|Secondary|Percentage of Participants With ACR 50 Response Over Time|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.|||percentage of participants||95% Confidence Interval|Number
1253262|NCT00484289|Secondary|Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point.|||percentage of participants||95% Confidence Interval|Number
1253263|NCT00484289|Primary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.|From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.|||participants|||Number
1253264|NCT00484185|Other Pre-specified|Number of Participants Who Discontinued the Study Due to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who discontinued the study due to AEs was reported.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
1253265|NCT00484185|Other Pre-specified|Duration of Adverse Events (AEs)|Total time from onset of adverse event till the event is resolved. Duration of AE per event = AE stop date minus AE start date plus 1.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1253266|NCT00484185|Secondary|Percentage of Participants With Efficacy Evaluation|The efficacy of study drug was rated as ‘very effective’, ‘effective’, ‘slightly ineffective’ and ‘ineffective’.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1253267|NCT00484185|Secondary|Total Infusion of Study Medication|Total dose of study drug infused was calculated over the study duration.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once.|||IU||Standard Deviation|Mean
1253268|NCT00484185|Secondary|Average Infusion Dose of Study Medication|Average of dose per infusion per kilogram (kg) body weight was reported for prophylaxis purpose or on-demand therapy and surgery.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed)= participants evaluable for this measure and 'n' = participants evaluable for the specified category.|||international unit/kilogram (IU/kg)||Standard Deviation|Mean
1253269|NCT00484185|Secondary|Mean Number of Breakthrough Bleeds Within 48 Hours of Study Medication|Mean frequency of breakthrough (spontaneous/non-traumatic) bleeds of each participant within 48 hours of a preventive/prophylaxis dose of BeneFIX was calculated from number of irregular bleeding which occurred in each participant. Mean frequency breakthrough bleeds for total participants within 48 hours of a preventive/prophylaxis dose of BeneFIX was summarized.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||breakthrough bleeds||Standard Deviation|Mean
1253270|NCT00484185|Secondary|Mean Number of Infusion of Study Medication|Mean frequency of BeneFIX administration of each participant was calculated from number of BeneFIX infusions which each participant received for treatment of each new bleed. Mean frequency of BeneFIX administration for total participants was summarized.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||infusions||Standard Deviation|Mean
1253271|NCT00484185|Secondary|Number of Responses to On-demand Treatment With Study Medication|Responses to on-demand treatment were rated by participant/caregiver or physician each time the drug was administered, on 4-point scale. Score 1=excellent (definite pain relief [PR] and improvement [imp] within 8 hours [h] of infusion [inf], no additional inf); score 2=good (definite PR and imp within 8h of inf, at least 1 additional inf for complete resolution [CR] of bleeding or starting after 8h of inf, no additional inf); score 3=moderate (probable or slight imp starting after 8h of inf, at least 1 additional inf for CR of bleeding); score 4=no imp at all, or condition worsens).|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||responses|||Number
1253272|NCT00484185|Secondary|Mean Annualized Bleeding Rate (ABR)|An annualized bleeding rate (ABR) was calculated as the number of bleeds requiring administration of BeneFIX (for on-demand therapy and surgery), divided by total period of bleeding multiplied by 365.25. Total period of bleeding is the number of days on treatment for prophylaxis purpose and on-demand therapy and surgery.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||bleeds per year||Standard Deviation|Mean
1276010|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||270 days||||Percentage of participants|||Number
1253273|NCT00484185|Primary|Number of Participants With Unexpected Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Unexpected AEs were those that were not included in precaution of local product document.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
1253274|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) by Relationship|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. All causalities and drug-related AEs reported. Drug-related AEs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs).|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
1253275|NCT00484185|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed based on response to a question ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no-resolved'.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1253276|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Seriousness|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
1253277|NCT00484185|Primary|Number of Participants With Action Taken in Response to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. After an onset of an AE, relevant actions were undertaken on the study drug or the participant. Actions related to study drug included: dosage reduced, dosage increased, stopped temporarily or permanently, no action taken; actions related to participants included: withdrawal from the study, concomitant medication, no action taken or any other as per physician’s discretion.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1253278|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. Same participant may be represented in more than 1 category.|||participants|||Number
1253279|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Baseline Characteristics|AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AE assessed by baseline characteristics (chr) included age, gender, pediatric/geriatric status, liver disorder, BeneFIX treatment (previously/newly), factor nine (FIX) gene mutation, prior exposure to plasma-derived FIX products, prior FIX regimen(s) utilized, personal history of FIX inhibitor, family history of hemophilia B, severity of bleeding, medical history, concomitant medication and therapy.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
1253280|NCT00484159|Secondary|Successful Treatment|Greater or equal to 50% pain relief plus procedural satisfaction lasting at least 3 months. What is being measured is the number of participants with a positive outcome.|3-months postprocedure||||participants|||Number
1253281|NCT00484159|Primary|Cost Per Successful Procedure|Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.|3-months||||U.S. dollars|||Number
1253282|NCT00484094|Secondary|Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula|Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set.|||mL/min||Full Range|Median
1253283|NCT00484094|Secondary|Percentage of Participants With Survived Graft|Graft survival was defined as not showing graft loss at the time of evaluation.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set; Participants who had available data.|||Percentage of participants||95% Confidence Interval|Number
1253284|NCT00484094|Secondary|Percentage of Participants Alive|The investigator recorded the participant’s survival status and evaluation date on the CRF.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set; Participants who had available data.|||Percentage of participants||95% Confidence Interval|Number
1253294|NCT00483756|Secondary|Number of Participants With Clinically Significant Infections|Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator.|Baseline up to Month 12|FAS: all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1253285|NCT00484094|Secondary|Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies|Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set: Participants with efficacy data recorded on the case report form (CRF) at 6 months (±1 month) after initiating Rapamune administration or at the time of completing Rapamune administration (whichever was earlier) were included in the Efficacy Analysis Set.|||Percentage of participants||95% Confidence Interval|Number
1253286|NCT00484094|Primary|Percentage of Participants With Clinically Significent Abnormal Laboratory Test|Laboratory test was not mandatory because this study was a non-interventional study.|Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.|This analysis was not performed because laboratory data were not collected during the study.||||||
1253287|NCT00484094|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs|All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely”, were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.|Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.|Safety Analysis Set|||Percentage of participants|||Number
1253288|NCT00483938|Secondary|Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)|End of treatment response (ETR) was defined as “Success” if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as “Success”, if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as “Success”, if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point.|Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)|ITT population|||percentage of participants|||Number
1253289|NCT00483938|Secondary|Percentage of Participants With SVR (Groups C, D, E, and F)|SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.|At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)|ITT. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1253290|NCT00483938|Primary|Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)|SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.|At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)|Intent-to-treat (ITT) population included randomized participants who received at least one dose of study medication and who had a baseline HCV-RNA which was at least 15 IU/mL. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1253291|NCT00483756|Secondary|Severity of Dyspepsia Assessment (SODA)|SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal [Ab] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction).|Baseline, Month 6, 12|Data not analyzed since the SODA instrument was found irrelevant in the treated population.||||||
1253292|NCT00483756|Secondary|End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)|ESRD-SCL:43-item disease specific self-administered questionnaire. Participants’ rated question“At the moment,how much do you suffer?”for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0 - 40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.|Baseline, Month 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.|||units on a scale||Standard Deviation|Mean
1253293|NCT00483756|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36: standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 “how would you rate your health in general now?”(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.|||units on a scale||Standard Deviation|Mean
1253295|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 * (serum creatinine)^(-1.154) * (age in years)^(-0.203) * (0.742 if female) * (1.210 if black). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.|||mL/min per 1.73 m^2||Standard Deviation|Mean
1253296|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine)^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration)^(-0.170) * (serum albumin concentration)^(0.318).A normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.|||mL/min/1.73 m^2||Standard Deviation|Mean
1253297|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.|||mL/min||Standard Deviation|Mean
1253298|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Nankivell Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using Last Observation Carried Forward (LOCF).|||mL/min||Standard Deviation|Mean
1253299|NCT00483756|Secondary|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants|||||||
1253300|NCT00483756|Secondary|Lymphocyte Subset|The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry.|Month 1, 3, 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.|||cells per microliter||Standard Deviation|Mean
1253301|NCT00483756|Secondary|Number of Participants Who Died||Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.|||participants|||Number
1253302|NCT00483756|Secondary|Number of Participants With Efficacy Failure|Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.|||participants|||Number
1253303|NCT00483756|Secondary|Number of Participants With Graft Loss|Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for >=6 consecutive weeks.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.|||participants|||Number
1253315|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|1.5 hours post-dosing|Modified ITT|||participants|||Number
1253316|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|1 hour post-dosing|Modified ITT|||participants|||Number
1253387|NCT00483184|Secondary|Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety||12 weeks|||||||
1253304|NCT00483756|Secondary|Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)|Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: ‘suspicious’ for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who were evaluable at given time point for each group, respectively.|||participants|||Number
1253305|NCT00483756|Secondary|Number of Participants With Treated Clinical Acute Rejection|Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.|||participants|||Number
1253306|NCT00483756|Secondary|Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant|Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 mg/dL and >=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy.|Baseline up to Month 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.|||participants|||Number
1253307|NCT00483756|Secondary|Number of Participants With Progression of Chronic Allograft Lesions at Month 12|Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions.|Month 12|Per protocol (PP) population: all randomized participants who received at least 1 dose of study treatment; excluding participants who had a protocol deviation thought to affect the analyses. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at both baseline and Month 12.|||participants|||Number
1253308|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) at Month 6|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 6.|||mL/min||Standard Deviation|Mean
1253309|NCT00483756|Primary|Glomerular Filtration Rate (GFR) at Month 12|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure.|2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 12.|||mL/min||Standard Deviation|Mean
1253310|NCT00483756|Primary|Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant|Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 milligram per deciliter (mg/dL) and >=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy.|Baseline up to Month 6|Full analysis set (FAS) with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.|||participants|||Number
1253311|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|48 hours post-dosing|Modified ITT|||participants|||Number
1253312|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|24 hours post-dosing|Modified ITT|||participants|||Number
1253313|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|4 hours post-dosing|Modified ITT|||participants|||Number
1253314|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|3 hours post-dosing|Modified ITT|||participants|||Number
1253319|NCT00483704|Secondary|Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)|TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.|From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 24 hours.|||Percentage of participants|||Number
1253320|NCT00483704|Secondary|Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)|TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of participants|||Number
1253321|NCT00483704|Secondary|Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)|Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication.|From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 48 hrs, or a recurrence question.|||Percentage of participants|||Number
1253322|NCT00483704|Secondary|Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)|Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.|From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.|||Percentage of participants|||Number
1253323|NCT00483704|Primary|Number of Participants Discontinuing Study Medication Due to an AE|Participants discontinuing study medication due to an AE were reported for all migraine attacks.|Up to the 4th dose of study medication (up to 6 months)|The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.|||Participants|||Number
1253324|NCT00483704|Primary|Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)|AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.|Up to 48 hours post-dose for the first migraine attack (up to 6 months)|The All-Patients-as-Treated (APaT) Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication for the first migraine attack, they were included in that treatment group.|||Participants|||Number
1253325|NCT00483704|Primary|Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether nausea was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for nausea severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.|||Percentage of participants|||Number
1253326|NCT00483704|Primary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose phonophobia measurement prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.|||Percentage of participants|||Number
1253327|NCT00483704|Primary|Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for photophobia severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.|||Percentage of participants|||Number
1253371|NCT00483379|Secondary|Change From Baseline in Left Ventricular Mass Index (LVMI) at Week 52|Cardiac pathophysiology was assessed by a central cardiologist using left ventricular mass index (LVMI) measured by echocardiogram at Baseline and after 12 months of treatment (Week 52). Left Ventricular Mass is adjusted to the participant's body surface area in the calculation of LVMI.|Baseline, Week 52|Full analysis population of participants with LVMI data at both timepoints|||g/m^2||Full Range|Median
1253328|NCT00483704|Primary|Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose|Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.|2 hours post-dose (up to 6 months)|The MFAS Population was defined as all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.|||Percentage of participants|||Number
1253329|NCT00483704|Primary|Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose|Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.|2 hours post-dose (up to 6 months)|The modified FAS (MFAS) Population consisted of all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.|||Percentage of participants|||Number
1253330|NCT00483704|Primary|Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)|Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of participants|||Number
1253331|NCT00483704|Primary|Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)|Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose for the first migraine attack (up to 6 months)|The full-analysis set (FAS) included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of participants|||Number
1253332|NCT00483652|Secondary|Change in Lower Extremity Manual Muscle Test [LEMMT]|Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.|Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77||||units on a scale||Standard Deviation|Mean
1253333|NCT00483652|Primary|Responders Based Upon the Timed 25-Foot Walk [T25FW]|A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)|Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77|Modified Intention-to-Treat [ITT] population|||participants|||Number
1253334|NCT00483574|Other Pre-specified|Safety Overview After Any Vaccination in Participants Who Received MMR+V||Day 0 to 7 Post-vaccination|Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines.|||Percentage of participants|||Number
1253335|NCT00483574|Primary|Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.|"Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling.~Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability"|Day 0 to 7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately.|||Percentage of participants|||Number
1253336|NCT00483561|Secondary|Biomarkers||At every cycle|Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.||||||
1253337|NCT00483561|Primary|Overall Response Rate as Measured by RECIST Criteria and PSA Criteria|If there is at least 1 response, then 7 additional patients will be enrolled. If there are 4 or more responders overall, then the combination will be considered active and warrant further study. Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy.|Approximately 3 years|Fifteen subjects were evaluable. A total of 26 subjects were consented; two were screen failures. Nine subjects were not evaluable due to coming off study prior to reaching the point of evaluation (2 cycles).|||Participants|||Count of Participants
1253346|NCT00483548|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint.|Baseline, Week 2, Week 4, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253388|NCT00483184|Primary|Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.|A patient with a 75% or greater decrease in total OU for three visits was considered a “sustained responder”.|(0-12 weeks)||||patients with sustained response|||Number
1253338|NCT00483548|Secondary|Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6|Q-LES-Q is a 16-item subject rated scale to measure satisfaction with areas of daily functioning (physical health, social relationships, medication, and overall life satisfaction); rated on a 5-point Likert scale: higher scores indicate greater enjoyment and satisfaction with general life activities. Scores for items 1 to 14 are summed for a total score and converted to 0 to 100 range. Items 15 and 16 measure satisfaction with medication and overall satisfaction and are analyzed separately. Change calculated as a difference between post-baseline observation and baseline Q-LES-Q score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253339|NCT00483548|Other Pre-specified|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores|AIMS is a clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe); items 11 to 14 are No or Yes response to dental status and sleep movements and are assessed separately. AIMS total score is sum of first 7 items. Change calculated as a difference between post-baseline observation and baseline AIMS score values.|Baseline, Week 2, Week 4, Week 6|ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253340|NCT00483548|Other Pre-specified|Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)|BARS is a clinician rated scale to evaluate akathisia associated with use of antipsychotic medications: objective motor restlessness, range 0 to 3; subjective complaints of restlessness and associated distress, range 0 to 3; global clinical assessment of akathisia, range 0 to 5. Higher scores indicate more affected. Change calculated as a difference between post-baseline observation and baseline BARS score values.|Baseline, Week 2, Week 4, Week 6|ITT; Summarized as Global BARS; individual scores not summarized; (n)=number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253341|NCT00483548|Other Pre-specified|Change From Baseline in Simpson Angus Scale (SAS) Score|SAS is a clinician rated 10-item scale to measure extrapyramidal side effects (Parkinsonism or Parkinsonian side effects induced with antipsychotics); rated on a 5-point scale with range 0 (absence of condition) to 4 (presence of condition in extreme form). Global score is sum of all scores divided by the total number of items. Change calculated as a difference between post-baseline observation and baseline SAS score values.|Baseline, Week 2, Week 4, Week 6|ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253342|NCT00483548|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)|SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||days||Standard Deviation|Mean
1253343|NCT00483548|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)|SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253344|NCT00483548|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6|GAF is a clinician rated scale to measure the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale (single score of 1 to 100) with 100 indicating a superior level of function. Change calculated as a difference between post-baseline observation and baseline GAF score values.|Baseline, Week 6|ITT; observed cases; Early Termination (ET) visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253345|NCT00483548|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score|YMRS is clinician rated 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253389|NCT00483119|Secondary|Ability to be Weaned Off Steroids||Measured 6 and 10 weeks after initiation of IVIg treatment|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.||||||
1253347|NCT00483548|Secondary|CGI-Improvement Score|CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. Week 6 is the primary timepoint.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253348|NCT00483548|Secondary|Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253349|NCT00483548|Secondary|Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.|||scores on scale||Standard Deviation|Mean
1253350|NCT00483548|Secondary|Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6|Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected.|Baseline, Week 6|ITT; LOCF|||participants|||Number
1253351|NCT00483548|Secondary|MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6|Number of subjects with reduction of ≥50 percent (%) in MADRS total score (indicates response). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as ([A-B]/B*100): A=value at observation; B=baseline value.|Week 6|ITT; LOCF|||participants|||Number
1253352|NCT00483548|Secondary|MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6|Number of subjects with MADRS total score ≤ 12 (indicates remission). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms).|Week 6|ITT; Last observation carried forward (LOCF)|||participants|||Number
1253353|NCT00483548|Secondary|Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.|Baseline, Week 6|ITT|||scores on scale||Standard Deviation|Mean
1253354|NCT00483548|Primary|Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.|Baseline, Week 6|Intent to Treat analysis set (ITT): all randomized subjects who received at least 1 dose of double-blind treatment and had at least 1 post-baseline primary efficacy evaluation.|||scores on scale||Standard Deviation|Mean
1253355|NCT00483496|Secondary|Adverse Events||through study completion||||Participants|||Count of Participants
1253356|NCT00483496|Primary|Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products|"MUD was defined as the minimal dose for occurrence of objective signs of SU (wheal, flare) under exposure to the solar simulator. Results are expressed as photodermatosis protection factor (PPF), calculated by dividing the MUD of protected skin (sessions 2 to 5) by the MUD of the unprotected skin (session 1) in each treatment group.~Procedure: At baseline, 4 grids of 8 adjacent test areas on the patient back were defined. The defined test areas of each grid were applied with the respective test products by the investigating staff at the beginning of each session, according to a predefined randomisation schedule. Grids were sequentially irradiated one by one with 1 MUD (session 2) , 3 MUD (session 3) , 5 MUD (session 4), and 7 MUD (session 5), respectively. After product removal at each session, patients were observed for 30 min for the development of SU lesions. Final reading of all areas was performed at the end of each session, by the investigator masked to product site assignment."|During each one of the 5 sessions, at study day||||Photodermatosis Protection Factor||Full Range|Mean
1253370|NCT00483379|Secondary|Change From Baseline in Ventilator Use at Last Assessment (Approximately Week 52)|The change from baseline in ventilator use at the last assessment is summarized as improved (less use of ventilator support), no change, worsened (increased use of ventilator support), and did not use ventilator support.|Baseline, approximately Week 52|Full analysis population. The participant in the worsened category died after week 52.|||participants|||Number
1253357|NCT00483405|Secondary|Time to Progression|Time to progression will be calculated from the time of enrollment until confirmed disease progression. Defined by RECIST (Response Evaluation Criteria in Solid Tumors), Progressive Disease (PD) – at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Median 23 month follow-up|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.|||months||95% Confidence Interval|Median
1253358|NCT00483405|Secondary|Overall Survival|Overall survival will be calculated from time of enrollment to death or last contact date.|Median 23 month follow-up|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.|||months||95% Confidence Interval|Median
1253359|NCT00483405|Secondary|Number of Subjects Experiencing Adverse Events|Adverse events will be assessed using CTCAE criteria.|every 3 weeks of treatment with an average of 15 weeks on treatment||||Participants|||Count of Participants
1253360|NCT00483405|Primary|Disease Response Rate|"Radiographic response will be measured every six weeks while subject is on treatment. Response will be measured using RECIST criteria.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions."|42 days (2 cycles)|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.|||percentage of participants with response||95% Confidence Interval|Number
1253361|NCT00483379|Primary|Summary of Participants Reporting Treatment-Emergent Adverse Events During the Treatment Period|Overall safety summary of participants experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on Treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment.|Day 1 up to Week 52|Safety population comprised of all participants who received intervention.|||participants|||Number
1253362|NCT00483379|Primary|Participants' Efficacy Response During the Treatment Period as Compared to Baseline for Participants With Motor Function Decline on Standard Treatment|Participants were enrolled based on clinical decline or sub-optimal clinical response in cardiac, respiratory and/or motor function parameters pre-study while on standard treatment. Each participant was evaluated at Week 52 for change from baseline in the criteria that declined; motor function decline primarily based on Gross Motor Function Measure 66 and Pompe Pediatric Evaluation of Disability Inventory results is summarized. Participants could gain motor function (improve), had no change (declined stopped), or continued loss (worsened). Each participant served as his or her own control.|Baseline, Week 52|All participants who enrolled due to decline in motor function while on standard treatment.|||participants|||Number
1253363|NCT00483379|Secondary|Change From Baseline in Normative Physical Component Summary of Medical Outcomes Study Short Form Health Survey (SF-36) at Week 52|Health related quality of life is measured using the Physical Component Summary (PCS) score of the Medical Outcomes Study (MOS) Short Form Health Survey (SF-36) for participants ≥14 years of age. SF-36 normative-based scoring has a mean of 50 and a standard deviation of 10. Higher scores represent better quality of life.|Baseline, Week 52|Full analysis population of participants >= 14 years old.|||units on a scale||Standard Deviation|Mean
1253364|NCT00483379|Secondary|Baseline Values for Normative Physical Component Summary of Medical Outcomes Study Short Form Health Survey (SF-36)|Health related quality of life is measured using the Physical Component Summary (PCS) score of the Medical Outcomes Study (MOS) Short Form Health Survey (SF-36) for participants ≥14 years of age. SF-36 normative-based scoring has a mean of 50 and a standard deviation of 10. Higher scores represent better quality of life.|Day 0|Full analysis population of participants >= 14 years old.|||units on a scale||Standard Deviation|Mean
1253365|NCT00483379|Secondary|Change From Baseline in Mobility as Measured by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at Week 52|The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. Change from baseline results for the mobility domain are reported. Scaled scores are used as an evaluative measure of change in performance over time with acquisition of new skills or new levels of independence. The range of scores is from 0-100 with scores near “0” reflecting low capability and scores near “100” reflecting high capability.|Baseline, Week 52|Full analysis population|||units on a scale||Standard Deviation|Mean
1253366|NCT00483379|Secondary|Baseline Values in Mobility as Measured by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI)|"The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. Baseline results for the mobility domain are reported. Scaled scores are used as an evaluative measure of change in performance over time with acquisition of new skills or new levels of independence. The range of scores is from 0-100 with scores near 0 reflecting low capability and scores near 100 reflecting high capability."|Day 0|Full analysis population|||units on a scale||Standard Deviation|Mean
1253367|NCT00483379|Secondary|Change From Baseline in Raw Scores for Gross Motor Function Measure 66 (GMFM-66) Results at Week 52|The Gross Motor Function Measure 66 contains sixty-six questions with a total raw score range of 0 - 198. Raw scores are derived from the following dimensions: Lying and rolling = 12; Sitting = 45; Crawling and kneeling = 30; Standing = 39; Walking, running and jumping = 72. Higher scores indicate better gross motor functions.|Baseline, Week 52|Full analysis population|||units on a scale||Standard Deviation|Mean
1253368|NCT00483379|Secondary|Baseline Values of Raw Scores for Gross Motor Function Measure 66 (GMFM-66) Results|The Gross Motor Function Measure 66 contains sixty-six questions with a total raw score range of 0 - 198. Raw scores are derived from the following dimensions: Lying and rolling = 12; Sitting = 45; Crawling and kneeling = 30; Standing = 39; Walking, running and jumping = 72. Higher scores indicate better gross motor functions.|Day 0|Full analysis population|||units on a scale||Standard Deviation|Mean
1253369|NCT00483379|Secondary|Change From Baseline in Body Strength Measured by the Manual Muscle Testing (MMT) Total Score at Week 52|Body strength is measured by the MMT score on a scale of 0-10 with higher scores representing greater body strength.|Baseline, Week 52|Full analysis population of participants >= 8 years old. Due to the age restriction and small study population, the number of participants analyzed is too small for results to be meaningful.||||||
1253373|NCT00483379|Secondary|Change From Baseline in Left Ventricular Mass (LVM) Z-Score at Week 52|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline an increase in LVM Z-score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. The Z-scores for all parameters are calculated with reference to the normative data from the Children’s Hospital, Boston, MA (Colan, 1992, J Am Coll Cardiol) based on the reference population with matched body surface area (BSA). Z-scores for LVM were provided by the central cardiologist.|Baseline, Week 52|Full analysis population of participants with LVM data at both timepoints|||Z-score||Full Range|Median
1253374|NCT00483379|Secondary|Baseline Values for Left Ventricular Mass (LVM) Z-Scores|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. Negative values indicate a smaller than mean LVM and values higher than 0 indicate a larger LVM than the mean. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. The Z-scores for all parameters are calculated with reference to the normative data from the Children’s Hospital, Boston, MA (Colan, 1992, J Am Coll Cardiol) based on the reference population with matched body surface area (BSA). Z-scores for LVM were provided by the central cardiologist.|Day 0|Full analysis population of participants with LVM data|||Z-score||Full Range|Median
1253375|NCT00483379|Primary|Participants' Efficacy Response During the Treatment Period as Compared to Baseline for Participants With Respiratory Decline on Standard Treatment|Participants were enrolled based on clinical decline or sub-optimal clinical response in cardiac, respiratory and/or motor function parameters pre-study while on standard treatment. Each participant was evaluated at Week 52 for change from baseline in the criteria that declined; respiratory decline as measured by change in ventilator use is summarized in this outcome. Ventilator use might have improved (less use of ventilator support), had no change, or worsened (more use of ventilator support). Each participant served as his or her own control.|Baseline, Week 52|All participants who enrolled due to decline in respiratory function while on standard treatment.|||participants|||Number
1253376|NCT00483327|Secondary|Number of Women Who Became Pregnant||up to 3 years after the treatment for each patient|Only 7 participants in the trial pursued pregnancy.|||participants|||Number
1253377|NCT00483327|Secondary|Duration of Response|For each patient, assessed every 12 weeks during treatment and every 6 months during follow-up.|up to 4 years|The original PI for this study is no longer at our institution. Additionally, co-investigator has stated that this data was not collected and therefore not analyzed. This information is not available for reporting as it does not exist.||||||
1253378|NCT00483327|Secondary|Toxicity and Tolerability|Patients with adverse events (AEs) which were possibly, probably, or definitely related to the treatment. AEs were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) 3.|up to 36 months|Any patient with at least one dose of treatment.|||participants|||Number
1253379|NCT00483327|Primary|Best Pathologic Responses|Patients are evaluated every 12 weeks while on treatment. The response is evaluated by endometrial biopsy or dilation and curettage (D&C)/hysteroscopy. Complete response (CR) is defined as endometrial sampling is read as normal or proliferative endometrium. Partial response (PR) is defined as the biopsy sample has changed on the endometrial evaluation scale by at least one level towards normal. Stable disease (SD) is defined as no change in pathology between the index and follow-up sample. Progressive disease (PD) is defined the follow-up sample has changed towards neoplasia on the endometrial evaluation scale by at least one level or imaging is concerning for myometrial invasion or extrauterine disease such that conservative management is no longer medically appropriate.|up to 24 months|Patient who were able to complete at least one full course (12 weeks) of treatment|||participants|||Number
1253380|NCT00483262|Secondary|Progression-Free Survival|Median time to progression or death|10 months||||month||95% Confidence Interval|Median
1253381|NCT00483262|Primary|Best Response to Combination Treatment|Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma|10 months|All patients included in analysis|||percentage of patients||90% Confidence Interval|Number
1253382|NCT00483262|Primary|Toxicity. Number of Patients With Specific Toxicities Are Reported.|Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.|10 months|Any patient who was treated was included in the analysis.|||percentage of patients||95% Confidence Interval|Number
1253383|NCT00483223|Secondary|Progression Free Survival and Overall Survival|Median progression free survival and overall survival (progression determined using RECIST) during a median follow-up time of 50 months.|5 years||||Months||Full Range|Median
1253384|NCT00483223|Secondary|Objective Response Rate Categorized by Subgroup|The number of participants achieving an objective response (as determined by RECIST) categorized by treatment cohort and whether the treatment was first or second line treatment. First line treatment means that the drug used was the first drug used for the treatment of the primary cancer. Second line treatment means that a first line treatment failed to produce the desired response, so a new drug was used for treatment.|3 years|Response rate is divide by drug cohort and categorized by first or second-line treatment|||Participants|||Count of Participants
1253385|NCT00483223|Primary|Response Rate Categorized by p63/p73 Ratio|Response rate categorized by pre-specified ΔNp63/TAp73 expression ratio cutoff in the primary tumors from this patient cohort as a bio-marker to predict response to cisplatin or carboplatin. Response is defined as partial or completed response as determined by RECIST. Expression ratio was measured using quantitative RT-PCR (Reverse transcription polymerase chain reaction).|3 years|Patients from either cohort with a tumor sample available to evaluate for expression ratio.|||Participants|||Count of Participants
1253386|NCT00483223|Primary|Objective Response Rate|"Objective response rate (ORR) (complete response [CR]+ partial response [PR]) by RECIST (Response Evaluation Criteria In Solid Tumors).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions, taking as reference the baseline sum LD~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|3 years||||Participants|||Count of Participants
1288223|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6||Month 6||||L||Standard Error|Mean
1253392|NCT00483119|Primary|Clinical Outcome: Extent and Severity of Disease||6 - 10 weeks after initiation of therapy|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.||||||
1253393|NCT00483041|Secondary|Volume at Distribution (Vz)|Vz of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Milliliter||Geometric Coefficient of Variation|Geometric Mean
1253394|NCT00483041|Secondary|Volume at Steady State (Vss)|Vss of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Milliliter||Geometric Coefficient of Variation|Geometric Mean
1253395|NCT00483041|Secondary|Terminal Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Day||Geometric Coefficient of Variation|Geometric Mean
1253396|NCT00483041|Secondary|Clearance (CL)|CL of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Milliliters per day||Geometric Coefficient of Variation|Geometric Mean
1253397|NCT00483041|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Percentage of Total Area||Geometric Coefficient of Variation|Geometric Mean
1253398|NCT00483041|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
1253399|NCT00483041|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
1253400|NCT00483041|Secondary|Peak Concentration (Cmax)|Cmax of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1253401|NCT00483041|Secondary|Time to Peak Concentration (Tmax)|Tmax of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Day||Geometric Coefficient of Variation|Geometric Mean
1253402|NCT00483041|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 84, and 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10). One subject in the 9 mg/kg group had no sample collected on Day 126.|||Participants|||Number
1253403|NCT00483041|Secondary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).|||Participants|||Number
1253404|NCT00483041|Secondary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).|||Participants|||Number
1253405|NCT00483041|Primary|Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL)|The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration.|Baseline (2 to 4 weeks prior to Day 0) and Day 15|All subjects who were randomized (n=11), received at least one dose of investigational product (MEDI-528 or placebo; n=10), and completed the 2-day BAL and segmental allergen challenge procedures at baseline (2-4 weeks prior to Day 0) and on Days 14 and 15 (n=2; 1 subject in each treatment group).|||Picograms per milliliter|||Number
1253406|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence for at Least Week 11|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|At least Week 11|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1253407|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|Week 7 through Week 11|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1253408|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|Week 3 through Week 7|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1253409|NCT00482911|Secondary|Changes in Gene Expression, Methylation and Protein Modification|Ribonucleic acid (RNA), deoxyribonucleic acid (DNA) and protein obtained from blood, urine and/or tissue was to be evaluated for changes in gene expression, methylation and/or protein modification.|Baseline and end of treatment course 1 and 2, approximately 42 days|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished||||||
1253410|NCT00482911|Secondary|Progression Free Survival|Proportion of patients who progress or die after the start of treatment|up to 16 months|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished||||||
1253411|NCT00482911|Primary|Overall Survival|Time from date of on study to the date of death from any cause or last follow up|up to 16 months|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished.||||||
1253412|NCT00482911|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|16 months|Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.|||Participants|||Number
1253413|NCT00482911|Primary|Response Rate (Complete and Partial Response)|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|2 years|Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.|||Participants|||Number
1253414|NCT00482729|Other Pre-specified|Number of Patients With A1C < 7.0% at Week 44||Week 44|The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.|||Participants|||Number
1253415|NCT00482729|Other Pre-specified|Change From Baseline in A1C at Week 44|A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.|Baseline and Week 44|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.|||Percent||95% Confidence Interval|Least Squares Mean
1253416|NCT00482729|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18|FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.|Baseline and Week 18|The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.|||mg/dL||95% Confidence Interval|Least Squares Mean
1253417|NCT00482729|Secondary|Number of Patients With A1C < 7.0% at Week 18||Week 18|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.|||Participants|||Number
1253418|NCT00482729|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 18|A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥ 1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.|||Percent||95% Confidence Interval|Least Squares Mean
1253419|NCT00482703|Other Pre-specified|Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table)|Progressed disease=achieving a CHR and subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose and an increase in white blood cell count (doubling of the count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done at least 2 weeks apart); meeting the criteria of accelerated or blastic phase CML at any time; having an MCyR and subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)|||participants|||Number
1253420|NCT00482703|Other Pre-specified|Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table)|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)|||participants|||Number
1253421|NCT00482703|Other Pre-specified|Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table)|MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in BM: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 6)|||participants|||Number
1264837|NCT00399542|Secondary|Month 1 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1253422|NCT00482703|Secondary|Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|All treated participants|||percentage of participants||95% Confidence Interval|Number
1253423|NCT00482703|Secondary|Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study|Cytogenetic response (CyR) as reflected in the major cytogenetic response was determined by bone marrow (BM) aspirates and are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each BM sample. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), or Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|All treated participants|||percentage of participants||95% Confidence Interval|Number
1253424|NCT00482703|Secondary|Mutational Spectrum of BCR-ABL|Number of participants with a particular BCR-ABL mutation at Baseline and End-of-Study.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|Treated participants|||participants|||Number
1253425|NCT00482703|Secondary|Expression of BCR-ABL Gene Mutations of RNA (mRNA)|Number of participants with positive (>= 2.0 log copies/mg) and negative (<2.0 log copies/mg) expression of mRNA at Baseline and at end of study.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|Treated participants|||participants|||Number
1253426|NCT00482703|Secondary|Progression-Free Survival (PFS)|Progressed disease=achieving a CHR & subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose & increase in white blood cell count (doubling of count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done ≥2 weeks apart); meeting the criteria of accelerated or blastic phase chronic myeloid leukemia at any time; having an MCyR & subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.|time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met|Median months of progression-free survival was not reached at the time of this report. See corresponding life table in Outcome Measure 16.|||months||95% Confidence Interval|Median
1253427|NCT00482703|Secondary|Duration of CHR|The duration of CHR were measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death. Subjects who neither progress nor die were censored on the date of their last hematologic assessment.|measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death|Median duration of CHR was not reach at the time of this report. See corresponding life table presented in Outcome Measure 15.|||months||95% Confidence Interval|Median
1253428|NCT00482703|Secondary|Time to CHR|Time to CHR = time from first dose of Dasatinib until the first day CHR criteria are met (provided subjects achieved a cCHR). CHR=all of the following criteria: white blood cell count ≤ upper limit of normal; platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met|Treated participants - responders|||months||95% Confidence Interval|Median
1253429|NCT00482703|Secondary|Duration of MCyR|The duration of MCyR will be measured from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death. Subjects who neither progress nor die will be censored on the date of their last cytogenetic assessment.MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Philadelphia-positive (Ph+) Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death|Median duration was not reached at the time of this report; see Outcome Measure 14 for corresponding life table.|||months||95% Confidence Interval|Median
1253430|NCT00482703|Secondary|Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics|Blood sample collection for pharmacokinetic (PK) analysis that will contribute to PK modeling.|Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration.|Blood samples were collected for PK to be included in separate population PK analyses. No study specific PK analyses were planned for this report.|||participants|||Number
1253431|NCT00482703|Secondary|Time to Major Cytogenetic Response (MCyR)|Time to MCyR is defined as the time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met. MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met|Treated participants - responders|||months||95% Confidence Interval|Median
1253462|NCT00482274|Secondary|Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)|Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.|Average days to develop recurrence from treatment start date amount applicable participants|Due to the limited enrollment, this analysis was not completed.||||||
1269975|NCT00360334|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio from baseline to endpoint|26 weeks|Full Analysis Set|||Ratio||Standard Error|Least Squares Mean
1253432|NCT00482703|Secondary|Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Week 24|All treated participants|||percentage of participants||95% Confidence Interval|Number
1253433|NCT00482703|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day.|All treated participants|||participants|||Number
1253434|NCT00482703|Primary|Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24|Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|Week 24|All treated participants|||percentage of participants||95% Confidence Interval|Number
1253435|NCT00482677|Secondary|Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter|Overall survival for patients by Methylation status of the O6-methylguanine-DNA methyltransferase promoter|7 years|Patients with MGMT promoter methylated.|||Months||95% Confidence Interval|Median
1253436|NCT00482677|Secondary|Adverse Events|Evaluated according to CTCAE V3.0|7 years|||||||
1253437|NCT00482677|Secondary|Progression-free Survival|Time from date of randomization to the date of disease progression or death whichever came first, or censored at last disease assessment date.|7 years||||Months||95% Confidence Interval|Median
1253438|NCT00482677|Primary|Overall Survival|Time from date of randomization to the date of death of any causes, or censored at last known alive date.|7 years||||Months||95% Confidence Interval|Median
1253439|NCT00482625|Secondary|Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above|The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate.|Up to 20 weeks||||participants|||Number
1253440|NCT00482625|Secondary|Pancreas Calculated Concentration - OSI-420 (ng/g)|Pancreatic tissue concentration levels of Erlotinib (OSI-420)|20 weeks||||ng/g||Standard Deviation|Mean
1253441|NCT00482625|Secondary|Plasma Calculated Concentration - OSI-420 (ng/mL)|Plasma concentration levels of Erlotinib (OSI-420)|20 weeks||||ng/mL||Standard Deviation|Mean
1253442|NCT00482625|Secondary|Pancreas Calculated Concentration - OSI-774 (ng/g)|Pancreatic tissue concentration levels of Erlotinib (OSI-774)|20 weeks||||ng/g||Standard Deviation|Mean
1253443|NCT00482625|Secondary|Plasma Calculated Concentration - OSI-774 (ng/mL)|Plasma concentration levels of Erlotinib (OSI-774)|20 weeks||||ng/mL||Standard Deviation|Mean
1253444|NCT00482625|Primary|Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment|Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment|Pre-treatment and post-treatment||||participants|||Number
1253445|NCT00482612|Secondary|Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period|The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Day 1 to Day 15|The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.|||Number of participants|||Number
1253446|NCT00482612|Secondary|Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period|The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Day 1 to Day 15|The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.|||Number of participants|||Number
1253447|NCT00482612|Secondary|Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period|SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis.|Day 1 to Day 15|The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication and had baseline and at least one post-baseline measurement for at least one efficacy assessment.|||Minutes||Standard Deviation|Mean
1280507|NCT00265317|Secondary|Plasma Concentration of Soluble VEGFR-2 at Baseline||Baseline (Cycle 1, Day 1)|FA Set|||pg/mL||Full Range|Median
1253448|NCT00482612|Primary|Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period|TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis.|Day 1 to Day 15|The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication, and had baseline and at least one post-baseline measurement for at least one efficacy assessment.|||Minutes||Standard Deviation|Mean
1253449|NCT00482547|Other Pre-specified|Number of Subjects With a sUTI Catheterized for >=48 Hours.|sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|From time of catheterization until 10 days or 48 hours after catheter was removed|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.|||Participants|||Number
1253450|NCT00482547|Other Pre-specified|Number of Subjects With a bUTI Catheterized for >=48 Hours.|bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.|||Participants|||Number
1253451|NCT00482547|Secondary|Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL|The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI|10 days|Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints.|||Participants|||Number
1253452|NCT00482547|Secondary|Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours|The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 24 hours to 10 days|Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.|||Days||Standard Deviation|Median
1253453|NCT00482547|Secondary|Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours|Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 24 hours to 10 days|Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.|||Days||Standard Deviation|Median
1253454|NCT00482547|Secondary|Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours|The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 48 hours to 10 days|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion.|||Days||Standard Deviation|Median
1253455|NCT00482547|Primary|Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours|Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>=48 hours to 10 days|Efficacy Evaluable (48) population: Intent-to-treat (ITT) subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a bUTI after catheter insertion.|||Days||Standard Deviation|Median
1253456|NCT00482547|Secondary|Percentage of Participants With a bUTI After Catheterization for >= 48 Hours|The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|>=48 hours to 10 days|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.|||Percentage of Participants with a bUTI|||Number
1253457|NCT00482391|Secondary|Number of Patients Who Were Evaluated for Toxicity|Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.|2 years||||Participants|||Count of Participants
1253458|NCT00482391|Primary|Number of Patients Who Completed All Planned Therapy|The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.|2 years||||participants|||Number
1253459|NCT00482274|Secondary|Time to Death From Any Cause|Due to the limited enrollment, this analysis was not completed.|measured at date of death (no estimate available)|Due to the limited enrollment, this analysis was not completed.||||||
1253460|NCT00482274|Secondary|Time to Androgen Independent State|Due to the limited enrollment, this analysis was not completed.|Measured at date of documented androgen independence (no estimate available)|Due to the limited enrollment, this analysis was not completed.||||||
1253461|NCT00482274|Secondary|Time to Metastatic Disease|Due to the limited enrollment, this analysis was not completed.|Measured at Time of documented metastases (no historical estimate is available)|Due to limited enrollment, this analysis was not completed||||||
1253524|NCT00482053|Secondary|Median Time to Neutrophil Engraftment After Allogeneic Transplant|Reported as neutrophil engraftment after allogeneic transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant.|within 1 month||||Days||Full Range|Median
1253463|NCT00482274|Primary|Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml|Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.|While receiving study treatment (approximately 6 months)|Analysis includes all subjects who completed study regimen of 6 cycles.|||participants|||Number
1253464|NCT00482170|Secondary|Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
1253465|NCT00482170|Secondary|Influence of Co-morbidities on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
1253466|NCT00482170|Secondary|Influence of Dermatology Life Quality Index (DLQI) on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Standard Deviation|Mean
1253467|NCT00482170|Secondary|Influence of Participant's Global Assessment of Psoriasis on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant’s global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant’s assessment of psoriasis score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||mm||Standard Deviation|Mean
1253468|NCT00482170|Secondary|Influence of Participant's Assessment of General Health on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant’s assessment of general health score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||mm||Standard Deviation|Mean
1253469|NCT00482170|Secondary|Influence of Psoriasis Area Severity Index (PASI) on Participant Perception|Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Standard Deviation|Mean
1253470|NCT00482170|Secondary|Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Full Range|Median
1253525|NCT00482053|Secondary|Median Time to Platelet Engraftment After Autologous Transplant|Reported as platelet engraftment after autologous transplant, defined as platelet count > 20,000/µL, counting from the day of transplant.|within 1 month||||Days||95% Confidence Interval|Median
1288224|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1||Month 1||||L||Standard Error|Mean
1253471|NCT00482170|Secondary|Influence of Duration of Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||years||Standard Deviation|Mean
1253472|NCT00482170|Secondary|Influence of Prior Self-injection Experience on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
1253473|NCT00482170|Secondary|Influence of Prior Injection Experience on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
1253474|NCT00482170|Secondary|Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Standard Deviation|Mean
1253475|NCT00482170|Secondary|Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception|Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Full Range|Median
1253476|NCT00482170|Secondary|Influence of Socio-educational Status on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
1253477|NCT00482170|Secondary|Influence of Gender on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
1253478|NCT00482170|Secondary|Influence of Age on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||years||Standard Deviation|Mean
1253526|NCT00482053|Secondary|Median Time to Neutrophil Engraftment After Autologous Transplant|Reported as neutrophil engraftment after autologous transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant.|within 1 month||||Days||Full Range|Median
1280508|NCT00265317|Secondary|Plasma Concentration of VEGF-C at Baseline||Baseline (Cycle 1, Day 1)|FA Set|||picograms (pg)/mL||Full Range|Median
1253479|NCT00482170|Secondary|Short Form State-Trait Anxiety Inventory (SF STAI) Global Score|SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||units on a scale||Standard Deviation|Mean
1253480|NCT00482170|Secondary|Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection|"Side effects related to administration were assessed by participant's response to question, Do you experience pain during or immediately after the injection? scored on a 5-point Likert scale (0= none to 4= severe)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253481|NCT00482170|Secondary|Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks|"Device characteristics were assessed by participant's response to question, How much does the device look like something you would feel comfortable to use? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253482|NCT00482170|Secondary|Device Characteristics Based on Response to Question Concerning Feel of Device|"Device characteristics were assessed by participant's response to question, How much do you like the feel of the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253483|NCT00482170|Secondary|Device Characteristics Based on Response to Question Concerning Look of Device|"Device characteristics were assessed by participant's response to question, How much do you like the look of the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253484|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection|"Fear of Device was assessed by participant's response to question, Are you emotionally distressed or anxious about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253485|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device|"Fear of Device was assessed by participant's response to question, Do you dislike injecting yourself with this device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253486|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin|"Fear of Device was assessed by participant's response to question, How nervous do you feel about inserting the needle into your skin? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253487|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections|"Fear of Device was assessed by participant's response to question, How nervous do you feel about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253488|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection|"Confidence in injection device was assessed by participant's response to question, How confident are you that you injected yourself successfully? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253489|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process|"Confidence in injection device was assessed by participant's response to question, Are you confident that you have good control over the injection process? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253490|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device|"Confidence in injection device was assessed by participant's response to question, How confident are you that you can inject yourself properly with the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253491|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time|"Confidence in injection device was assessed by participant's response to question, How confident are you that you inject the right amount of medicine every time? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1264838|NCT00399542|Secondary|Month 3 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1253492|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections|"Confidence in injection device was assessed by participant's response to question, How confident are you in your management of your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253493|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling|"Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253494|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity|"Convenience of injection device was assessed by participant's response to question, Do you think injecting etanercept will interfere with your usual daily activities? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253495|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity|"Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
1253496|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)|"Ease of Use of Injection Device was assessed by participant's response to question, How long does it take to perform the injection, including any preparation and disposal? where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
1253497|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting|"Ease of use of injection device was assessed by participant's response to question, Did you feel any hand discomfort whilst using the device? scored on a 5-point Likert scale (0= none to 4= extreme)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
1253498|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting|"Ease of use of injection device was assessed by participant's response to question, How easy is it to hold the device whilst injecting? scored on a 5-point Likert scale (0= very easy to 4= very difficult)"|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
1253499|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete|"Ease of use of injection device was assessed by participant's response to question, How easy is it to know when the injection is completed? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
1253500|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to dispose of the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
1253501|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to use the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
1253502|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to perform an injection with this device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
1253725|NCT00479674|Secondary|Median Proportion Progression-free as Estimated by Kaplan-Meier Methods|PFS was defined as time from trial enrollment to disease progression or death, whichever occurred first.|5 years|One subject lost to follow up and not included in analysis.|||months||95% Confidence Interval|Median
1253503|NCT00482170|Secondary|Influence of Prior Injection Experience on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253504|NCT00482170|Secondary|Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253505|NCT00482170|Secondary|Influence of Co-morbidities on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253506|NCT00482170|Secondary|Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =< 8, > 8 to 13, > 13 to 18, > 18.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253507|NCT00482170|Secondary|Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant’s global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant’s global assessment of psoriasis scores observed. Participants were divided into quarters: =< 63, > 63 to 76, > 76 to 88, > 88.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253508|NCT00482170|Secondary|Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =< 48, > 48 to 67.25, > 67.25 to 84, > 84.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253509|NCT00482170|Secondary|Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =< 11.2, > 11.2 to 16.2, > 16.2 to 21.9, > 21.9.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253510|NCT00482170|Secondary|Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =< 3, > 3 to 4, > 4.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253511|NCT00482170|Secondary|Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =< 11 years, > 11 years to 19 years, > 19 years to 28 years, > 28 years.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253527|NCT00482053|Primary|Event-free Survival (EFS) Per Protocol|Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death.|48 months|Reported data values are limited by protocol-specified upper boundary for the timeframe of this assessment.|||months||95% Confidence Interval|Median
1253512|NCT00482170|Secondary|Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253513|NCT00482170|Secondary|Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =< 47.4, > 47.4 to 56.4, > 56.4 to 68.5, > 68.5.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253514|NCT00482170|Secondary|Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =< 4, > 4 to 7, > 7 to 10, > 10 for HAD-A and =< 3, > 3 to 5, > 5 to 8, > 8 for HAD-D.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253515|NCT00482170|Secondary|Influence of Socio-educational Status on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253516|NCT00482170|Secondary|Influence of Gender on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1253517|NCT00482170|Secondary|Influence of Age on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=<) 36 years, greater than (>) 36 years to 45 years, > 45 years to 55 years, > 55 years.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Last observation carried forward (LOCF) method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1253518|NCT00482170|Secondary|Percentage of Participants Satisfied With Injection Device|Participant satisfaction was assessed by asking the question “Are you satisfied with your injection device? and using a dichotomous response: Yes or No.|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||percentage of participants|||Number
1253519|NCT00482170|Primary|Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population|"Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied."|Week 12|Per-protocol (PP) analysis population included participants from mITT population who completed the study with no major protocol violations. Here, ‘N’ (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1253520|NCT00482170|Primary|Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population|"Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied."|Week 12|Modified intent-to-treat (mITT) analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Here, ‘N’ (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1253521|NCT00482053|Secondary|Overall Survival (OS)|To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant.|3 years||||Participants|||Count of Participants
1253522|NCT00482053|Secondary|Incidence of Chronic Graft vs Host Disease (GvHD)|The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD.|3 years||||Participants|||Count of Participants
1253523|NCT00482053|Secondary|Median Time to Platelet Engraftment After Allogeneic Transplant|Reported as platelet engraftment after allogeneic transplant, defined as platelet count > 20,000/µL, counting from the day of transplant.|within 1 month|Note: all participants engrafted platelets on the same day (see below for data values).|||Days||Full Range|Median
1253529|NCT00482014|Secondary|Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)|Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Phase 2 randomization to the end of the treatment up to 30.0 months|All randomization participants in Study Phase 2.|||percentage of participants||95% Confidence Interval|Number
1253530|NCT00482014|Secondary|Phase 2 - Median Survival||Phase 2 randomization to death as the result of any cause up to 30.0 month|All randomized participants in Study Phase 2.|||months||95% Confidence Interval|Median
1253531|NCT00482014|Secondary|Phase 2 - Time to Progression|Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Phase 2 randomization to measured disease progression up to 24 months|All randomized participants in Study Phase 2.|||months||95% Confidence Interval|Median
1253532|NCT00482014|Secondary|Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events|Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section.|Phase 2 randomization to the end of the study treatment up to 30.0 months|All randomized participants who received at least 1 dose of study drug or 1 dose of radiation therapy (RT) during Study Phase 2.|||participants|||Number
1253533|NCT00482014|Secondary|Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)|Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Phase 1 enrollment to the end of the study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy.|||percentage of participants||95% Confidence Interval|Number
1253534|NCT00482014|Secondary|Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)|Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death.|Phase 1 enrollment up to Week 11|All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy.|||participants|||Number
1253535|NCT00482014|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin|MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).|Phase 1 enrollment to the end of study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + cisplatin treatment.|||milligrams/meter squared (mg/m²)|||Number
1253536|NCT00482014|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin|MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).|Phase 1 enrollment to the end of study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + carboplatin treatment.|||milligram/milliliter*minute (mg/mL*min)|||Number
1253537|NCT00481988|Secondary|Beck Depression Inventory II|patient self report of depressive symptoms|Two weeks|Data for the secondary outcome measure was incompletely collected and not analyzed.||||||
1253538|NCT00481988|Primary|Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression).|The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS < 10 for 2 weeks.|Two weeks|20 patients were enrolled in the study and 17 patients completed it. The 17 patients who completed the study are the population analyzed.|||participants|||Number
1253539|NCT00481871|Secondary|Progression-free Survival (PFS) Time|PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death – study day 1 + 1).|Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study||||days||95% Confidence Interval|Median
1255324|NCT00467363|Primary|Live Birth|Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .|after delivery|Analyses were based on the intention-to-treat principle (excluding participants lost to follow-up).|||livebirths|||Number
1253540|NCT00481871|Secondary|Duration of Response|Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death – date of first objective response assessment + 1)|Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study||||days||Full Range|Median
1253541|NCT00481871|Primary|Objective Responses Assessed by International Workshop Criteria (IWC)|Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.|Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I|All patients who completed at least 1 cycle of treatment were included in the efficacy analysis|||participants|||Number
1253542|NCT00481845|Secondary|Pathologic Complete Response||1 year|CR+PR|||Participants|||Count of Participants
1253543|NCT00481845|Primary|Tumor Objective Response by MRI|Determine tumor objective response rate by MRI. (CR): Disappearance of the target lesion (PR): At least a 30% decrease in the longest diameter of the target lesion taking as reference the baseline LD (PD): At least a 20% increase in the LD of target lesion, taking as reference the baseline LD or the appearance of one or more new lesions (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline LD.|1 year||||Participants|||Count of Participants
1253544|NCT00481832|Secondary|Median Time to Platelet Engraftment|Complete blood counts were measured daily after allogeneic transplant. Time to platelet engraftment is defined as the number of days it takes to reach platelet count >20,000, counting from the day of transplant.|Up to 45 days||||Days||Full Range|Median
1253545|NCT00481832|Secondary|Achieving Full Donor Chimerism|Achieving full donor chimerism (donor T cells >95%): Blood was sent for donor cell percentage measured by short tandem repeat (STR) at post-transplant Day 30; Day 60; Day 90; Day 120; Day 180; Day 270; and Day 360. Full donor chimerism is defined as donor CD3+ cells > 95%.|Up to 1 year||||Participants|||Count of Participants
1253546|NCT00481832|Secondary|Median Time to Neutrophile Engraftment|Complete blood counts were measured daily after allogeneic transplant. Time to neutrophil engraftment is defined as the number of days it takes to reach an absolute neutrophils count (ANC) >500, counting from the day of transplant.|up to 45 days||||Days||Full Range|Median
1253547|NCT00481832|Secondary|Overall Mortality Rate|Overall mortality is determined by Kaplan-Meier estimation. The overall morality rate is expressed as the percentage of patients who died for any reason, including disease-related death.|3 years||||percentage of participants||95% Confidence Interval|Number
1253548|NCT00481832|Secondary|Incidence of Chronic Graft Versus Host Disease (GvHD)|The development of GvHD in vaccinated patients of any grade at 6 months.|3 years||||Participants|||Count of Participants
1253549|NCT00481832|Secondary|Incidence of Acute Graft Versus Host Disease (GvHD)|The development of GvHD in vaccinated patients of any grade and at 6 months.|6 Months|Only 13 participants received both therapies and were evaluated for GVHD|||Participants|||Count of Participants
1253550|NCT00481832|Secondary|Overall Survival (OS)|Overall Survival (OS) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation.|3 years||||percentage of participants||95% Confidence Interval|Number
1253551|NCT00481832|Secondary|Relapse Rate|Relapse rate (disease recurrence) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation.|3 years||||percentage of participants||95% Confidence Interval|Number
1253552|NCT00481832|Secondary|Incidence of Chemotherapy-associated Pneumonitis|Interstitial pneumonitis (IP) is a risk associated with high-dose carmustine (BCNU) or other chemotherapy drugs used for transplantation. IP is diagnosed by 1) a decrease of >25% in DLCO compared with pre-transplant PFT DLCO values or 2) a drop of 7% or more in oxygen saturation after exertion.|3 years||||Participants|||Count of Participants
1253553|NCT00481832|Primary|Event-free Survival (EFS)|"Event-free survival (EFS) as determined for participants who receive both planned transplants, for a minimum of 3 years.~Events are defined as “disease progression/relapse” and “death of all causes”."|3 years||||percentage of participants||95% Confidence Interval|Number
1253554|NCT00481767|Secondary|Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed|"Biochemical and haematological parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.~N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 12|The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.|||Participants|||Count of Participants
1253555|NCT00481767|Secondary|Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed|"Biochemical and haematological parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.~N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 12|The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.|||Participants|||Count of Participants
1253575|NCT00481676|Secondary|Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study|Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.|At the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Participants|||Number
1253556|NCT00481767|Secondary|Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed|"Biochemical and haematological parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.~N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 7|The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.|||Participants|||Count of Participants
1253557|NCT00481767|Secondary|Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed|"Biochemical and haematological parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.~N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 7|The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.|||Participants|||Count of Participants
1253558|NCT00481767|Secondary|Number of Subjects With Pregnancies and Their Outcomes|Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented and who reported pregnancies (and their outcomes).|||Participants|||Count of Participants
1253559|NCT00481767|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7 and from Month 7 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1253560|NCT00481767|Secondary|Number of Subjects With NOCDs and Other MSCs|New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 7 and from Month 7 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1253561|NCT00481767|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.|Within 30 days (Day 0-29) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1253562|NCT00481767|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|Within 7 days (Day 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1253563|NCT00481767|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity.|Within 7 days (Day 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1253564|NCT00481767|Secondary|GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 2 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1253668|NCT00480636|Secondary|Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)|Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.|Baseline through Month 6 or EOT (up to Month 6)|Safety analysis set.|||Participants|||Number
1253565|NCT00481767|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|"A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 2 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1253566|NCT00481767|Primary|Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 7|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1253567|NCT00481767|Primary|Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies|"A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 7|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1253568|NCT00481676|Secondary|Investigator’s Global Assessment of the Patient’s Chronic Urticaria Symptoms|The investigator made a global assessment of the patient’s chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.|At Baseline and at the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Participants|||Number
1253569|NCT00481676|Secondary|Patient’s Global Assessment of Their Chronic Urticaria Symptoms|Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.|At Baseline and at the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Participants|||Number
1253570|NCT00481676|Secondary|Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)|The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1253571|NCT00481676|Secondary|Change in the Skindex Score From Baseline to the End of the Study (Week 24)|Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients’ quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1253572|NCT00481676|Secondary|Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)|The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1253573|NCT00481676|Secondary|Use of Concomitant and Rescue Medications|Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.|At Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Pills||Standard Deviation|Mean
1253574|NCT00481676|Secondary|Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1253821|NCT00478244|Secondary|Number of Patients With Resistance to Blister Formation|Resistance to Blister Formation demonstrated by response to negative pressure.|Month 1 through Month 24 Inclusive|Added blister formation testing later in study; only 2 patients had pre-transplant test.|||participants|||Number
1253576|NCT00481676|Primary|Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1253577|NCT00481507|Secondary|Absences From Daycare or School Owing to Illness, Missed Parental Work Owing to the Child Being Ill, Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools.||14 days|||||||
1253578|NCT00481507|Primary|Percentage of Participants With Diarrhea by Parental Report|The primary outcome was the percentage of participants receiving antibiotics with diarrhea during the 14-day follow-up period, as determined by parental report.|14 days|Prior estimates of the sample size showed that 62 per group would have 80% power for detecting a difference of 20% in the rates of diarrhea. This was based on the placebo group having a 10% (which is consistent with published literature) rate of diarrhea. Analysis performed used the intention to treat and no imputation was required.|||percentage of participants|||Number
1253579|NCT00481351|Secondary|High Density Lipoprotein||12 week||||mg/dl||Standard Deviation|Mean
1253580|NCT00481351|Secondary|Total Cholesterol||12 week||||mg/dl||Standard Deviation|Mean
1253581|NCT00481351|Secondary|CPK||12 week||||mg/dl||Standard Deviation|Mean
1253582|NCT00481351|Secondary|Alanine Aminotransferase||12 weeks||||mg/dl||Standard Deviation|Mean
1253583|NCT00481351|Primary|Low Density Lipoprotein||12week||||mg/dl||Standard Deviation|Mean
1253584|NCT00481351|Secondary|Triglyceride Fractional Clearance Rate||6week||2010-11-30|11/2010||||
1253585|NCT00481351|Primary|Cholesteryl Ester Fractional Clearance Rate||6 weeks||2011-07-31|07/2011||||
1253586|NCT00481247|Other Pre-specified|Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results|ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE. Absolute neutrophil count: Grade 3 <1000-500/mm^3; Grade 4 <500/mm^3. Hemoglobin: Grade 3 <8.0-6.5 g/dL; Grade 4 <6.5 g/dL. Platelets: Grade 3 <50,000-25,000/mm^3; Grade 4 <25,000/mm^3. ALT/AST: Grade 3 >5.0-20*ULN; Grade 4 >20*ULN. Total bilirubin: Grade 3 >3-10*ULN; Grade 4 >10*ULN. Sample normal ranges (may vary by institution): ALT, Female: 7-30 U/L, Male: 10-55 U/L; AST, Female: 9-25 U/L, Male10-40 U/L; Total bilirubin: 0.0-1.0 mg/dL. Creatinine: Grade 3 >3.0–6.0*ULN; Grade 4 >6.0*ULN. Phosphate: Grade 3 <2.0–1.0 mg/dL; Grade 4 <1.0 mg/dL. Calcium: Grade 3 <7.0–6.0 mg/dL; Grade 4 <6.0 mg/dL. Potassium: Grade 3 <3.0–2.5 mmol/L; Grade 4 <2.5 mmol/L.|From date of last person, first visit to date of last person, last visit (approximately 8 years)|Participants with laboratory assessments|||Participants|||Number
1253587|NCT00481247|Other Pre-specified|Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From date of last person, first visit to date of last person, last visit (approximately 8 years)|All treated participants|||Participants|||Number
1253588|NCT00481247|Secondary|Percentage of Participants With Overall Survival (OS)|OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.|Participants were followed-up for at least 5 years|All randomized participants|||Percentage of participants|||Number
1253589|NCT00481247|Secondary|Percentage of Participants With Progression-free Survival (PFS)|PFS was defined as the time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date and after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.|Participants were followed-up for at least 5 years|All randomized participants|||Percentage of participants|||Number
1253590|NCT00481247|Secondary|Time to Major Molecular Response (MMR) Overall|The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.|Day 1 to 5 years|All participants who received treatment and achieved MMR|||Months||95% Confidence Interval|Median
1253591|NCT00481247|Secondary|Time to Confirmed Complete Cytogenic Response (cCCyR) Overall|The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants.|Day 1 to 5 years|All randomized participants who achieved cCCyR|||Months||95% Confidence Interval|Median
1253592|NCT00481247|Secondary|Percentage of Participants With Major Molecular Response (MMR) at Any Time|Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).|Planned total follow-up duration of 5 years|All randomized participants|||Percentage of participants|||Number
1264839|NCT00399542|Secondary|Month 2 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1253593|NCT00481247|Secondary|Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)|"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.~Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1."|Years 2, 3, 4 and 5|All randomized participants who achieved cCCyR|||percentage of participants||95% Confidence Interval|Number
1253594|NCT00481247|Primary|Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.|Pretreatment, every 3 months up to 12 months|All randomized participants|||Participants|||Number
1253595|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 8|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 8 are presented."|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at week 8|||Participants|||Number
1253596|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 6|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 6 are presented."|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at Week 6|||Participants|||Number
1253597|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 4|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 4 are presented."|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at 4 weeks|||Participants|||Number
1253598|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 3|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 3 are presented."|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at 3 weeks|||Participants|||Number
1253599|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 2|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 2 are presented."|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and week 2|||Participants|||Number
1253600|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 1|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 1 are presented."|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at Baseline and Week 1|||Participants|||Number
1253879|NCT00477750|Secondary|Time to Progression (TTP)|TTP was defined as the time from registration to disease progression. Patients who died were considered to have disease progression at time of death unless documented evidence clearly indicates no progression has occurred|registration to progressive disease (up to 3 years)|||||||
1253601|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Endpoint are presented."|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects assessed by CGI-BP at Baseline and at least one observation after Baseline.|||Participants|||Number
1253602|NCT00481195|Secondary|Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 8 Weeks|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the HAM-A at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253603|NCT00481195|Secondary|Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 4 Weeks|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the HAM-A at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253604|NCT00481195|Secondary|Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety, 25-30 moderate to severe, >30 very severe. The data presented here summarizes the change in HAM-A score from Baseline to Endpoint (8 weeks or last observation after baseline).|baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the HAM-A at baseline and at least once after baseline|||Units on a scale||Standard Error|Least Squares Mean
1253605|NCT00481195|Secondary|Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 8 weeks.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed questionnaire at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253606|NCT00481195|Secondary|Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 4 weeks.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the questionnaire at baseline and at 4 weeks.|||Units on a scale||Standard Error|Least Squares Mean
1253607|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to endpoint (8 weeks or last observation after baseline).|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the questionnaire at baseline and at any appropriate time point after baseline|||Units on a scale||Standard Error|Least Squares Mean
1253608|NCT00481195|Secondary|Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 8.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253727|NCT00479557|Secondary|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)|IgG subtypes were not assessed|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|||||||
1288225|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1||Month 1||||L||Standard Error|Mean
1253609|NCT00481195|Secondary|Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 6.|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 6 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253610|NCT00481195|Secondary|Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253611|NCT00481195|Secondary|Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 3.|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at week 3|||Units on a scale||Standard Error|Least Squares Mean
1253612|NCT00481195|Secondary|Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 2|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253613|NCT00481195|Secondary|Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 1|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 1 week|||Units on a scale||Standard Error|Least Squares Mean
1253614|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Endpoint (Week 8 or last observation after baseline).|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at least one observation after baseline.|||Units on a scale||Standard Error|Least Squares Mean
1253615|NCT00481195|Secondary|Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 8.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 8|||Units on a scale||Standard Error|Least Squares Mean
1253616|NCT00481195|Secondary|Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 4|||Units on a scale||Standard Error|Least Squares Mean
1253632|NCT00481195|Secondary|The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253617|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the change in MADRS from Baseline to Endpoint.|Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)|Full analysis set defined as subjects who had both a baseline observation and at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1253618|NCT00481195|Secondary|Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 8 in the score of Item 4 assessing hypersomnia.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8|||Units on a scale||Standard Error|Least Squares Mean
1253619|NCT00481195|Secondary|Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 4 in the score of Item 4 assessing hypersomnia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects assessed with IDS-C30 at baseline and at week 4|||Units on a scale||Standard Error|Least Squares Mean
1253620|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to Endpoint in the score of Item 4 assessing hypersomnia.|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects assessed with IDS-C30 at baseline and at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1253621|NCT00481195|Secondary|Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 8 in the combined score of these three items assessing insomnia.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8|||Units on a scale||Standard Error|Least Squares Mean
1253622|NCT00481195|Secondary|Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 4 in the combined score of these three items assessing insomnia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by IDS C30 at baseline and Week 4|||Units on a scale||Standard Error|Least Squares Mean
1253623|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to Endpoint in the combined score of these three items assessing insomnia.|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline and at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1253647|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine|Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.|21 days after second and third vaccinations (day 22 and day 43)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
1253759|NCT00479258|Secondary|Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c||12 months|||||||
1253760|NCT00479258|Secondary|Slope for Other PFT Parameters;||12 months|||||||
1253624|NCT00481195|Secondary|"Number of Patients Achieving Sustained Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained response (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline|||Participants|||Number
1253625|NCT00481195|Secondary|"Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained remission (total score <= 11 that persists over the four week period from Week 4 to Week 8)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline|||Participants|||Number
1253626|NCT00481195|Secondary|"Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a response (> 50% decrease from baseline in total score)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline|||Participants|||Number
1253627|NCT00481195|Secondary|Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score <=11).|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who had completed IDS-C30 at baseline and at least one observation after baseline|||Participants|||Number
1253628|NCT00481195|Secondary|The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed at baseline and at 8 weeks with the IDS-C30.|||Units on a scale||Standard Error|Least Squares Mean
1253629|NCT00481195|Secondary|The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30.|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 6 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253630|NCT00481195|Secondary|The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253631|NCT00481195|Secondary|The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30.|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 3 weeks|||Units on a scale||Standard Error|Least Squares Mean
1253666|NCT00480636|Secondary|Number of Participants With Recurrent DVT|Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits|Month 6 or EOT (up to Month 6)|FAS|||Participants|||Number
1253761|NCT00479258|Secondary|Change From Baseline in FVC||12 months|||||||
1253762|NCT00479258|Secondary|Treatment Preferences.||12 months|||||||
1253633|NCT00481195|Secondary|The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at week 1 after start of study drug administration|||Units on a scale||Standard Error|Least Squares Mean
1253634|NCT00481195|Primary|The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.|Baseline and 8 weeks from start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at least one time point after baseline|||Units on a scale||Standard Error|Least Squares Mean
1253635|NCT00481078|Secondary|Overall Survival|Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.|Up to 1 year||||Months||95% Confidence Interval|Median
1253636|NCT00481078|Secondary|Progression-free Survival|Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.|Up to 1 year||||Months||95% Confidence Interval|Median
1253637|NCT00481078|Primary|Response Rate|"Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data).~Patients with confirmed CR or PR according to the RECIST criteria were considered to have responded to treatment."|Assessed every two cycles||||percentage of responding patients||95% Confidence Interval|Number
1253638|NCT00481065|Secondary|Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine|For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose.|21 days after booster vaccination (day 403)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
1253639|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second and third vaccinations (day 43 and day 403)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
1253640|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second and third vaccinations (day 43 and day 403)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
1253641|NCT00481065|Secondary|Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine|"Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.~The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382."|21 days after booster vaccination (day 403)|Full analysis set (FAS)|||Subjects|||Number
1253642|NCT00481065|Primary|Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second vaccination (day 43)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
1253643|NCT00481065|Primary|Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)|"seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).|||Subjects|||Number
1253644|NCT00481065|Primary|Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)|"seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).|||Subjects|||Number
1253645|NCT00481065|Primary|Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)|"seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second vaccination (day 43)|The analysis was done on the full analysis set (FAS).|||Subjects|||Number
1253646|NCT00481065|Secondary|Number of Subjects Reporting Local and Systemic Reactions by Vaccination|The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine.|21 days after second and third vaccinations (day 43 and day 403)||||Subjects|||Number
1253648|NCT00481065|Primary|Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine|"Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH).~Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).|||Subjects|||Number
1253649|NCT00480987|Primary|Number of Participants With Objective Response|Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/Liters or more and platelet count of 100*10^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100*10^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts >/= 50% and not more than 6-25% abnormal cells in the marrow.|After 2 months|Analysis was per protocol. All participants treated were analyzed.|||Participants|||Number
1253650|NCT00480857|Secondary|The Number of Patients Alive|The number of patients alive at 4 years.|4 years||||Participants|||Count of Participants
1253651|NCT00480857|Secondary|The Number of Patients That Experience Evidence of Local Recurrence|The number of patients that have local disease recurrence by imaging and clinical findings.|4 years||||Participants|||Count of Participants
1253652|NCT00480857|Secondary|The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities|"To determine the rates of toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.~G1 events are considered mild. G2 events are considered moderate G3 events are considered severe G4 events are considered life-threatening"|4 years||||percentage of patients|||Number
1253653|NCT00480857|Secondary|Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less|To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.|4 years||||patients|||Number
1253654|NCT00480857|Primary|Percentage of Patients Alive Without Progression at 4 Years|The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.|4 years||||percentage of patients||95% Confidence Interval|Number
1253655|NCT00480779|Secondary|Change in Triglycerides|A secondary outcome for this study will be change in Triglyceride level, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Inter-Quartile Range|Median
1253656|NCT00480779|Secondary|Change in Diastolic Blood Pressure|A secondary outcome for this study will be change in diastolic blood pressure, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mmHg||Standard Deviation|Mean
1253657|NCT00480779|Secondary|Change in Systolic Blood Pressure|A secondary outcome for this study will be change in systolic blood pressure, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mmHg||Standard Deviation|Mean
1253658|NCT00480779|Secondary|Change in Hemoglobin A1C|A secondary outcome for this study will be change in HbA1c, measured pre and post intervention. The hemoglobin HbA1c test provides information regarding how well blood glucose (sugar) has been controlled for the previous 8-12 weeks..|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1253659|NCT00480779|Secondary|Change in Fasting Glucose|A secondary outcome for this study will be change in fasting glucose, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Standard Deviation|Mean
1253660|NCT00480779|Secondary|Change in LDL Cholesterol|A secondary outcome for this study will be change in LDL cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Standard Deviation|Mean
1253661|NCT00480779|Secondary|Change in HDL Cholesterol|A secondary outcome for this study will be change in HDL cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Standard Deviation|Mean
1253662|NCT00480779|Secondary|Change in Total Cholesterol|A secondary outcome for this study will be change in total cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Standard Deviation|Mean
1253663|NCT00480779|Secondary|Change in Waist Circumference|A secondary outcome for this study will be change in waist circumference, measured pre and post intervention.|Baseline and 3 months|Intent to treat|||inches||Standard Deviation|Mean
1253664|NCT00480779|Primary|Change in Weight|The primary outcome for this study will be change in weight measured pre and post intervention.|Baseline and 3 months|Intent to treat using Last Observation Carried Forward (LOCF)|||pounds||Standard Deviation|Mean
1253665|NCT00480740|Primary|Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.|"Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values.~Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia."|Up to 24 hours following cardiac catheterization||||percentage of change from baseline||95% Confidence Interval|Mean
1253667|NCT00480636|Secondary|Percent of Participants With and Without Pulmonary Embolism (PE)|PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)|Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)|FAS. n = number of participants per PE status at observation.|||Percent of participants|||Number
1253669|NCT00480636|Secondary|Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood|Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.|Baseline through Month 6 or EOT (up to Month 6)|The safety analysis set was defined as all participants who received at least 1 dose of study treatment.|||Participants|||Number
1253670|NCT00480636|Primary|Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg|Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg|Month 6 or End of Treatment (EOT) (up to Month 6)|Full analysis set (FAS): all participants who received at least 1 dose of the study treatment and who had at least 1 post baseline efficacy measurement.|||Participants|||Number
1253671|NCT00480532|Secondary|Subject Compliance|measured by self report of pill intake on daily diary (yes/no), and reported as percentage with no missed pills over entire study|Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline.||||number of participants with no missed pi|||Number
1253672|NCT00480532|Secondary|Subject Satisfaction.|"measured using 100 mm visual analog scale. anchors of not at all satisfied (0mm) extremely satisfied (100mm)"|Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period.||||mm||Standard Deviation|Mean
1253673|NCT00480532|Primary|Differences in Bleeding Patterns Between Study Groups.|number of days of bleeding and spotting, self reported on calendar|The outcome was also assessed for day 1 to 84|All participants analyzed in the groups to which they were randomized except for 1 subject in prevention placebo group who was erroneously enrolled although she did not meet enrollment entry criteria|||days||Standard Error|Mean
1253674|NCT00480493|Primary|Worry|Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry|12 months||||units on a scale||Standard Deviation|Mean
1253675|NCT00480493|Primary|Parent Concern|Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.|12 months||||units on a scale||Standard Deviation|Mean
1253676|NCT00480493|Primary|Maternal Confidence Scale|Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)|12 months|All participants with data were analyzed|||units on a scale||Standard Deviation|Mean
1253677|NCT00480324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to 2 years of age|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1253678|NCT00480324|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1253679|NCT00480324|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.|During the 8-day follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1253680|NCT00480324|Secondary|Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies|Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.|2 months after Dose 2|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.|||subjects|||Number
1253681|NCT00480324|Secondary|Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration|Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).|2 months after Dose 2|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.|||Units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
1253682|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From Dose 1 up to 2 years of age|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1253683|NCT00480324|Secondary|Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains|Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
1253726|NCT00479674|Primary|"Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III Triple Negative Metastatic Breast Cancer."|Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.|5 years|2 subjects withdrew and were not assessed for response|||percentage of participants||95% Confidence Interval|Number
1253684|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
1253685|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
1253686|NCT00480324|Secondary|Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
1253687|NCT00480324|Primary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
1253688|NCT00479882|Secondary|Percentage Change From Baseline in HDL-C at Week 4|Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.|Baseline (Day1 of Period I) and Week 4|Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1253689|NCT00479882|Secondary|Percentage Change From Baseline in LDL-C at Week 4|Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.|Baseline (Day1 of Period I) and Week 4|Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1253690|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Non-serious Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253691|NCT00479882|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253708|NCT00479856|Secondary|Duration of Response|For the subset of participants with a confirmed CR or PR, duration of response was measured as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|time from first documented evidence of CR or PR until the first documented sign of disease progression or death (approximately 95 weeks)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint was evaluated.|||weeks||95% Confidence Interval|Median
1289125|NCT00135707|Secondary|Fetal or Neonatal Death||During pregnancy or thorugh discharge||||Participants|||Count of Participants
1253692|NCT00479882|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined, where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). Excludes 6 participants who had an AE that began during the placebo run-in.|||Percentage of Participants|||Number
1253693|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253694|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253695|NCT00479882|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253696|NCT00479882|Secondary|Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline|Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants with diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253697|NCT00479882|Secondary|Percentage of Participants With New Diagnosis of Diabetes|Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253698|NCT00479882|Secondary|Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose|Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became ‘impaired’ during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who had normal fasting blood glucose levels at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253721|NCT00479713|Primary|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment|Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1253699|NCT00479882|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253700|NCT00479882|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253701|NCT00479882|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253702|NCT00479882|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1253703|NCT00479882|Secondary|Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1253704|NCT00479882|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1253705|NCT00479856|Secondary|Number of Participants With the Indicated Serious Adverse Events and Adverse Events|Qualitative and quantitative toxicities associated with the combination of capecitabine, docetaxel, or nab-paclitaxel and lapatinib were measured. Data are presented as serious adverse events (SAEs) and adverse events (AEs). See the SAE/AE section of the results record for data.|Baseline through End of Treatment, or discontinuation of study therapy (approximately 95 weeks); from the first dose of lapatinib until 5 days after the last dose of lapatinib||||participants|||Number
1253706|NCT00479856|Secondary|Progression-free Survival|The time from the start of treatment until the earliest date of disease progression or death due to any cause was measured.|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks); dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint of overall response rate was evaluated.|||weeks||95% Confidence Interval|Median
1253707|NCT00479856|Secondary|Time to Response (TTR)|TTR is defined as the time from the start of treatment until the first documented evidence of PR or CR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the TTR was taken to be the first time that the response was observed.|start of treatment until first documented evidence of CR or PR (approximately 95 weeks)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint was evaluated.|||weeks||95% Confidence Interval|Median
1253722|NCT00479674|Secondary|to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS)||18 months|Study plan stipulated that tissue samples would not be assessed for quantitatively if no difference in SPARC expression was observed between tumor and non-tumor cells was observed qualitatively.||||||
1253709|NCT00479856|Secondary|Clinical Benefit (CB)|CB is defined as the percentage of participants (par.) with either a confirmed CR or PR or stable disease (SD) for at least 24 weeks. SD is defined as small changes that do not meet criteria for CR, PR, or Progressive Disease (defined as at least a 20% increase in the sum of the longest diameter of target lesions).|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)|Due to the low incidence of relapse and hence the difficulty in identifying eligible par., the study was terminated with only 9 out of the 45 planned par. enrolled. As there were too few par. to derive statistically meaningful conclusions, only the primary endpoint was evaluated.|||percentage of participants|||Number
1253710|NCT00479856|Primary|Overall Tumor Response|Overall tumor response is defined as the percentage of participants with a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as the disappearance of all target lesions. CR could only be declared if all target and non-target lesions had disappeared. Partial response (PR) is defined as a decrease of 30% or greater in the sum of the longest diameter of target lesions.|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 wks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, of other reason)|All Treated Subjects (ATS) Population: all participants who received at least one dose of study treatment|||percentage of participants|||Number
1253711|NCT00479765|Primary|Occurence of Dose-limiting Toxicities (DLTs)|any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)|8 weeks||||dose limiting toxicities|||Number
1253712|NCT00479713|Other Pre-specified|Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein|Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Median
1253713|NCT00479713|Other Pre-specified|Percent Change From Baseline in Apolipoprotein B|Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1253714|NCT00479713|Other Pre-specified|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio|Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1253715|NCT00479713|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio|Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1253716|NCT00479713|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)|Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1253717|NCT00479713|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)|Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1253718|NCT00479713|Other Pre-specified|Percent Change From Baseline in Triglycerides.|Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Median
1253719|NCT00479713|Other Pre-specified|Percent Change From Baseline in Total Cholesterol|Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1253720|NCT00479713|Secondary|The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment|"The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment.~The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group."|after 6 weeks of treatment|Full Analysis Set (FAS)|||Percent of participant population|||Number
1253728|NCT00479557|Secondary|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/mL||95% Confidence Interval|Geometric Mean
1253729|NCT00479557|Secondary|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/mL||95% Confidence Interval|Geometric Mean
1253730|NCT00479557|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.|The safety population included all randomized participants with documented use of at least one dose of study drug.|||percentage of participants|||Number
1253731|NCT00479466|Secondary|Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1253732|NCT00479466|Secondary|Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1253733|NCT00479466|Primary|Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1253734|NCT00479401|Secondary|Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events||baseline and after 33 weeks of treatment|Treated set (TS)|||participants|||Number
1253735|NCT00479401|Secondary|Possible Clinically Significant Abnormal Laboratory Parameters|The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.|baseline and after 33 weeks of treatment|Treated Set Labs (TSLabs), all patients in TS with a clinical laboratory measurements at baseline and at the last visit.|||participants|||Number
1253736|NCT00479401|Secondary|Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)|mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4).|from trial start on to any time before final assessment of the patient, up to 33 weeks|Treated Set (TS), all randomized patients, who were dispensed study medication and documented to have taken at least 1 dose of study medication.|||patients|||Number
1253737|NCT00479401|Secondary|Patients Who Started to Use L-Dopa Rescue Medication|L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population|from trial start on to any time before final assessment of the patient, up to 33 weeks|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||patients|||Number
1253738|NCT00479401|Secondary|Change From Baseline in European Quality of Life Visual Analog Scale|European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status.|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
1253739|NCT00479401|Secondary|Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include:~mobility (e.g. fear of falling when walking): 10 items~activities of daily living (e.g. difficulty cutting food): 6 items~emotional well-being (e.g. feelings of isolation): 6 items~stigma (e.g. social embarrassment): 4 items~social support: 3 items~cognition: 4 items~communication: 3 items~bodily discomfort: 3 items.~A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement."|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
1253763|NCT00479258|Secondary|Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;||12 months|||||||
1253764|NCT00479258|Secondary|Change From Baseline in Other PFT Parameters||12 months|||||||
1253740|NCT00479401|Secondary|Parkinson's Disease Sleep Scale (PDSS)|PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150)|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
1253741|NCT00479401|Secondary|Likert Scale for Pain Related to PD|Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
1253742|NCT00479401|Secondary|Beck's Depression Inventory Version I A|The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression).|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
1253743|NCT00479401|Secondary|UPDRS Part III Total Score|UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
1253744|NCT00479401|Secondary|UPDRS Part II Total Score|UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
1253745|NCT00479401|Secondary|UPDRS Part I Change From Baseline|UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement|baseline and after 33 weeks treatment|Full Analysis Set with (LOCF), all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||Inter-Quartile Range|Median
1253746|NCT00479401|Secondary|UPDRS II+III Responder Rate (at Least 20% Improvement)|Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||percentage of responders|||Number
1253747|NCT00479401|Secondary|Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale|Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. Responders are the patients with 'much better' and 'very much better' on the score.|after 18 weeks of treatment compared to baseline|Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008|||Percentage of Participants|||Number
1253748|NCT00479401|Secondary|Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale|Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale|after 18 weeks of treatment compared to baseline|Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008|||Percentage of Participants|||Number
1253749|NCT00479401|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score|Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.|baseline and after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Least Squares Mean
1253750|NCT00479388|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and 12 Weeks|Full Analysis Set With at Least one Post-Titration Visit Measurement|||Percent||95% Confidence Interval|Median
1253751|NCT00479388|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12||Baseline and 12 Weeks|Full Analysis Set|||Percent||95% Confidence Interval|Least Squares Mean
1253752|NCT00479388|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12||Baseline and 12 Weeks|Full Analysis Set|||Percent||95% Confidence Interval|Least Squares Mean
1253753|NCT00479336|Secondary|Abdominal Circumference|Change in abdominal circumference from baseline (LOCF)|Baseline, Day 7 or at the discontied of treatment|Full Analysis Set; LOCF|||cm||Standard Deviation|Mean
1253754|NCT00479336|Primary|Body Weight (Amount of Change)|Changes in body wight from baseline at the final timepoint (LOCF). A linear regression model using changes in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset.|Baseline, Day 7 or at the discontied of treatment|Full Analysis Set; LOCF|||Kg||Standard Deviation|Mean
1253755|NCT00479258|Secondary|7 Point Home Glucose||12 months|||||||
1253756|NCT00479258|Secondary|Hypoglycemic Event Rates;||12 months|||||||
1253757|NCT00479258|Secondary|Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;||12 months|||||||
1253758|NCT00479258|Secondary|Change From Baseline in Insulin Antibodies (microU/mL);||12 months|||||||
1253766|NCT00479232|Other Pre-specified|Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)|Objective Response Rate was measured in participants with intermediate-high risk MDS or untreated AML who were treated with vorinostat and decitabine either on a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for MDS participants.|Approximately 6 months||||percentage of participants|||Number
1253767|NCT00479232|Other Pre-specified|Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)|Objective Response Rate was measured in participants with refractory or relapse AML (acute myelogenous leukemia) in combination with Decitabine who were treated with vorinostat and decitabine on either a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for Myelodysplastic Syndrome (MDS) participants.|Approximately 6 months||||percentage of participants|||Number
1253768|NCT00479232|Primary|Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events|Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting >42 days.|Day 1 to 28 of Cycle 1||||participants|||Number
1253769|NCT00479154|Primary|Change in Restless Legs Syndrome Rating Scale|Primary outcome measure will be the mean change from baseline in RLS scale at week 2 following placebo/BTX injections. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40).|Week 2 and Week 4 for each intervention (vs. baseline)||||RLS Rating Score||Standard Deviation|Mean
1253770|NCT00479089|Secondary|Median Progression Free Survival From Trial Enrollment for Overall Study|Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.|From trial enrollment to disease progression or death, up to five years|Analysis by intent to treat population with all participants treated included.|||Months||Full Range|Median
1253771|NCT00479089|Secondary|Median Overall Survival|Overall survival was summarized using the Kaplan-Meier estimation.|Baseline till participant death or end of follow-up period, assessed every 4 weeks, up to 5 years.|Analysis by intent to treat population with all participants treated included.|||Months||Full Range|Median
1253772|NCT00479089|Primary|Number of Participants Free From Progression 9 Months From Start of Consolidation Therapy|The proportion of participants’ progression free at 9 months compared between treatments using chi-square. Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.|Assessment at 9 Months of therapy|In order to test the trial hypotheses for the two cohorts progression at nine months, a sample size of 45 participants for each arm was required. Accrual was not met to assess the outcome hypotheses thus no participant analysis available.||||||
1253773|NCT00479037|Secondary|Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial|"CTX is a marker of bone resorption, which is a degradation product of bone collagen.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||percent change||Standard Deviation|Mean
1253774|NCT00479037|Primary|Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial|"BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||percent change||Standard Deviation|Mean
1253775|NCT00479037|Primary|Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial|"P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||percent change||Standard Deviation|Mean
1253776|NCT00478933|Primary|Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype|The GNB3 c.825C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
1253777|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype|The GNAQ c.-387G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
1253778|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype|The GNAQ c.-382G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
1253779|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype|The GNAQ c.-909/-908GC>TT single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
1253780|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype|The GNAS c.2291C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
1253781|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype|The GNAS c.2273C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
1253782|NCT00478933|Secondary|All Cause Mortality, Cardiac Death and Atrial Fibrillation/Flutter||2 years|||||||
1253783|NCT00478933|Secondary|Hospitalization, Medical Interventions, Medication, Surgery, Additional Diagnostics||2 years|||||||
1253784|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype|The GNAS c.393C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
1253785|NCT00478881|Secondary|Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks|The OAB-q is a validated, self-administered questionnaire that quantifies bladder symptoms and quality of life. It comprises 33 items (6-point scale for each item). The total score ranges from 33 (minimum symptoms) to 198 (maximum symptoms). On each item, participants provide their rating over the past 4 weeks. Missing data were imputed by LOCF.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."|||scores on a scale||Standard Error|Least Squares Mean
1253786|NCT00478881|Secondary|Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older|Peak urinary flow (Qmax) was measured using urodynamic assessments (voiding / flow cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|mITT: Participants who received at least one dose, randomized correctly according to Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. Qmax is based on men predominantly aged 50 years and older but includes a few males who had Qmax collected even if younger than 50 years.|||milliliter per second (mL/s)||Standard Error|Least Squares Mean
1253787|NCT00478881|Secondary|Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks|The average number of daily involuntary discharges of urine was derived from the number of discharges reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."|||involuntary discharges per day||Standard Error|Least Squares Mean
1253788|NCT00478881|Secondary|Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks|The average number of urgencies was derived from the number of urgencies reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."|||urgencies per day||Standard Error|Least Squares Mean
1253789|NCT00478881|Secondary|Change From Baseline in Volume at First Desire to Void at 6 Weeks|Volume at first desire to void was recorded during urodynamic assessments. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||mL||Standard Error|Least Squares Mean
1253790|NCT00478881|Secondary|Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks|Maximum cystometric bladder capacity was defined as the volume at which either significant leakage or discomfort/pain occurred. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||mL||Standard Error|Least Squares Mean
1253791|NCT00478881|Secondary|Change From Baseline in Volume at First Detectable Leakage at 6 Weeks|First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure. Missing data was imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||mL||Standard Error|Least Squares Mean
1289126|NCT00135707|Secondary|Preterm Birth||Delivery||||Participants|||Count of Participants
1253792|NCT00478881|Secondary|Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks|Detrusor pressure was measured by means of urodynamic assessment (cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT) population: participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1253793|NCT00478881|Primary|Change From Baseline in Average Number of Daily Micturitions at 6 Weeks|Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."|||micturitions per day||Standard Error|Least Squares Mean
1253794|NCT00478881|Primary|Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks|Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)|"Modified intention-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||mL||Standard Error|Least Squares Mean
1253795|NCT00478777|Secondary|Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria|Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.|up to 827 days|Values for the free light chain concentrations were determined to be invalid.|||Days||Standard Deviation|Mean
1253796|NCT00478777|Secondary|Participants With Treatment-emergent Adverse Experiences (TEAEs)|"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.~National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death."|up to 8 months|Safety population|||participants|||Number
1253797|NCT00478777|Secondary|Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria|"Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD).~CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline."|Up to 827 days|Full analysis set|||participants|||Number
1253798|NCT00478777|Primary|Kaplan Meier Estimate for Time to Disease Progression|"Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease.~Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 827 days|Full analysis dataset|||days||95% Confidence Interval|Median
1253799|NCT00478673|Primary|Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)|12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.|12 Months|ITT Analysis: All enrolled subjects who experienced a 12-mo MAE and/or completed a follow-up evaluation >=335 days post-procedure were evaluable. Subjects who experienced more than one MAE within 12 months were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 12-mo MAE.|||Participants|||Number
1253800|NCT00478673|Primary|Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)|30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.|30 Days|ITT Analysis: All enrolled subjects who experienced a 30-day MAE and/or completed a follow-up evaluation >=23 days post-procedure were evaluable. Subjects who experienced more than one MAE within 30 days were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 30-day MAE.|||Participants|||Number
1253801|NCT00478647|Primary|Participants Who Experienced at Least One Adverse Event|"Safety was assessed throughout the study by assessments including adverse events, concomitant medication use, and vital signs. Additional safety assessments, including 12-lead ECGs, physical examinations, clinical laboratory tests and determination of the presence of anti-velaglucerase alfa antibodies.~Refer to Adverse event section for further details."|Week 53|Safety population included subjects who have received at least 1 full or partial dose of study drug.|||participants|||Number
1253802|NCT00478647|Secondary|Percent Change From Baseline to Week 51 in Normalized Spleen Volume|Spleen volume has been normalized for percentage (%) of body weight. Spleen size relative to body weight= (Spleen volume [cc]/Body weight [kg])*100|Week 51|ITT population. Four splenectomized participants were excluded.|||Percent (%) change||90% Confidence Interval|Mean
1253803|NCT00478647|Secondary|Percent Change From Baseline to Week 51 in Normalized Liver Volume|Liver volume has been normalized for percentage (%) of body weight. Liver size relative to body weight= (Liver volume [cc]/Body weight [kg])*100|Week 51|ITT population.|||Percent (%) change||90% Confidence Interval|Mean
1253806|NCT00478608|Secondary|Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation|The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).|12 months after transplantation|Patients who received at least one dosing of SRL after transplantation.|||patients|||Number
1253807|NCT00478608|Secondary|Patient and Graft Survival|Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|12 months|Patients who received at least one dosing of SRL after transplantation.|||patients|||Number
1253808|NCT00478608|Secondary|Serum Creatinine|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.|Baseline, 6 and 12 months|Patients who received at least one dose of SRL after transplantation. Observed values|||mg/dl||Standard Deviation|Mean
1253809|NCT00478608|Secondary|Glomerular Filtration Rate (GFR) (Nankivell Method)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure.|6 and 12 months|Patients who received at least one dose of SRL after transplantation. Observed values|||mL/min||Standard Deviation|Mean
1253810|NCT00478608|Primary|Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.|The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).|6 months after transplantation|Patients who received at least one dosing of SRL after transplantation.|||patients|||Number
1253811|NCT00478569|Secondary|Treatment Compliance by Visit|"A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician’s advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.~Data on compliance were obtained at each visit and relate to the period since the previous recorded visit."|From enrollment to 3, 6, 12, 18, and 24 months||||participants|||Number
1253812|NCT00478569|Secondary|Duration of Treatment|Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.|24 months|Participants for whom data were available|||months||Full Range|Mean
1253813|NCT00478569|Secondary|Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment|A participant was defined as “permanently discontinued” if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as “temporarily discontinued” if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still “ongoing” during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as “missing” or “unknown” if they attended the relevant visit and there was no result or “unknown” was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.|From enrollment to 3, 12, 18, and 24 months|All enrolled participants|||participants|||Number
1253814|NCT00478569|Primary|Number of Participants Who Discontinued Before 6 Months of Treatment|"A participant was defined as permanently discontinued if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards."|6 months|All enrolled participants|||participants|||Number
1253815|NCT00478556|Secondary|Bowel Opacification Score|The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.|Collected day of study|per protocol - all patients had usable data|||units on a scale||Standard Deviation|Mean
1253816|NCT00478556|Primary|Preferred Contrast Agent|The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.|1 Day|Analysis was per protocol|||participants|||Number
1253817|NCT00478335|Primary|24h Urine Volume|urine volume in mL/d|4-days||||urine volume in mL/d||Standard Deviation|Mean
1253818|NCT00478257|Primary|Fatigue|The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is −24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.|four cycles of chemotherapy|All participants that were randomized and began the protocol were included in analyses.|||units on a scale||Standard Error|Mean
1253819|NCT00478244|Primary|Number of Patients With Detectable Collagen Type VII|Number of patients with epidermolysis bullosa who had collagen type VII. Type VII collagen defects cause recessive dystrophic epidermolysis bullosa (RDEB), a blistering skin disorder often accompanied by epidermal cancers.|Day 100 Post Transplant||||participants|||Number
1253820|NCT00478244|Secondary|Number of Patients With Neutrophil Engraftment|Number of patients with an absolute neutrophil count >5 x 10^8 cells/liter for 3 consecutive days.|Day 42 Post Transplant||||participants|||Number
1283991|NCT00211692|Secondary|Number of Participants Discontinuing Early From Study Treatment||through end of study up to 72 weeks||||participants|||Number
1253822|NCT00478244|Secondary|Number of Patients With Donor Derived Cells in Skin|Number of patients who had donor skin chimerism - donor cells in the patient's epidermis (a state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease).|Day 90 Post Transplant||||participants|||Number
1253823|NCT00478244|Secondary|Overall Survival|Survival is defined as the number of patients that were alive post transplant.|1 year and 2 years Post Transplant||||participants|||Number
1253824|NCT00478244|Secondary|Number of Patients With Chronic Graft-Versus-Host Disease (cGVHD)|Number of patients with cGVHD; a severe long-term complication created by infusion of donor cells into a foreign host.|Day 365 Post Transplant||||participants|||Number
1253825|NCT00478244|Secondary|Number of Patients With Acute Graft-Versus-Host Disease (GVHD)|Number of patients with GVHD. Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100 Post Transplant||||participants|||Number
1253826|NCT00478244|Secondary|Number of Patients With Platelet Engraftment|Number of patients with a platelet count >5 x 10^10 cells/liter for 3 consecutive measurements.|Day 180 Post Transplant||||participants|||Number
1253827|NCT00478244|Secondary|Number of Patients With Transplant-Related Mortality|Number of patients who died due to complications of the transplant (includes all deaths without previous relapse or progression).|Day 180 Post Transplant||||participants|||Number
1253828|NCT00478244|Secondary|Number of Patients With >70% Donor Chimerism|Number of patients with donor chimerism - percentage of donor cells in the patient via the peripheral blood or bone marrow.|Days 21, 100, 180, 365 and 730 Post Transplant||||participants|||Number
1253829|NCT00478231|Other Pre-specified|Number of Participants With Genotype Resistance|Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI).|Baseline through Week 96|FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. Here, the 'N = 167' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Participants|||Number
1253830|NCT00478231|Other Pre-specified|Time to Virologic Failure (VF)|Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification.|Baseline to Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation.|||Days||95% Confidence Interval|Median
1253831|NCT00478231|Other Pre-specified|Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/ml]).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Missing data was imputed using LOCF.|||log 10 copies/ml||Standard Deviation|Mean
1253832|NCT00478231|Secondary|Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status|Virus tropism was done by the Monogram Biosciences Trofile assay.|Time of virologic failure (VF) and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Participants|||Number
1253833|NCT00478231|Secondary|Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||Percent CD8||Standard Deviation|Mean
1253834|NCT00478231|Secondary|Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||Percent CD4||Standard Deviation|Mean
1253835|NCT00478231|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||cells/µL||Standard Deviation|Mean
1253836|NCT00478231|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS population included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||cells per microliter (cells/µL)||Standard Deviation|Mean
1253850|NCT00478205|Secondary|Change From Baseline to Week 24 in MMSE Total Score|The MMSE (Mini-Mental State Examination) is a 30-item test that evaluates 5 domains of cognitive function (orientation to time and place, immediate and delayed recall, attention, calculation, and language). The scores range from 0 (most impaired) to 30 (no impaiment).|Baseline and Week 24|ITT population, LOCF|||Scores on a scale||Standard Deviation|Mean
1253837|NCT00478231|Secondary|Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification|Below limit of quantification was defined as less than 400 copies/milliliter (mL)|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||Percentage of participants|||Number
1253838|NCT00478231|Secondary|Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA||Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||Percentage of participants|||Number
1253839|NCT00478231|Secondary|Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)||Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)|The full analysis set (FAS) included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Last Observation Carried Forward (LOCF) method was used.|||Percentage of participants|||Number
1253840|NCT00478231|Primary|Number of Participants With Laboratory Test Abnormalities|Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.|||Participants|||Number
1253841|NCT00478231|Primary|Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections|Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.|||Participants|||Number
1253842|NCT00478231|Primary|Number of Participants With Treatment Emergent Malignancies||Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.|||Participants|||Number
1253843|NCT00478231|Primary|Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities|Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Participants|||Number
1253844|NCT00478231|Primary|Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant’s usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.|Baseline to 30 days post-week 96 or early termination (ET)|The safety analysis set composed of all participants who received at least one dose of study medication.|||Participants|||Number
1253845|NCT00478218|Secondary|Duration of Response (DOR)|Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|Participants who achieved a partial response(PR) or better were evaluable for this analysis.|||months||95% Confidence Interval|Median
1253846|NCT00478218|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method. > Progression was defined as any one or more of the following: > An increase of 25% from lowest confirmed response in: >~Serum M-component (absolute increase >= 0.5g/dl) >~Urine M-component (absolute increase >= 200mg/24hour >~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl >~Bone marrow plasma cell percentage (absolute increase of >=10%)"|up to 5 years||||months||95% Confidence Interval|Median
1253847|NCT00478218|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|up to 5 years||||months||95% Confidence Interval|Median
1253848|NCT00478218|Primary|Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment|"Response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Duration of Treatment (up to 5 years)||||participants|||Number
1253849|NCT00478205|Primary|Overall Change From Baseline in Modified CIBIC+ to Week 24|The CIBIC+ is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).|Baseline and Week 24|ITT population, LOCF|||Scores on a scale||Standard Deviation|Mean
1253851|NCT00478205|Secondary|Change From Baseline to Week 24 in ADCS-ADL Total Score|The ADCS-ADL (Alzhemier's Disease Cooperative Study-Activities of Daily Living) is a 19-item assessment scale used to measure a patient's basic functional abilities, such as walking, grooming, and bathing.Scores range from 0 to 54, with a higher score indicating greater functional ability.|Baseline and Week 24|ITT population, LOCF|||Scores on a scale||Standard Deviation|Mean
1253852|NCT00478205|Primary|Change From Baseline to Week 24 in SIB Total Score|The SIB is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best). This outcome was calculated using the LOCF (last observation carried forward) method.|Baseline and Week 24|Intent-to-treat (ITT) population: All Randomized patients in Safety Population and Severe Impairment Battery (SIB) or Clinician Interview-Based Impression of Severity Plus Caregiver Input (CIBIS+) data available at Baseline and SIB or Clinician Interview-Based Impression of Change Plus caregiver Input (CIBIC+ ) data available post-Baseline; LOCF|||Scores on a scale||Standard Error|Least Squares Mean
1253853|NCT00478192|Secondary|Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment|"Free water clearance (FWC) was calculated as FWC=V(1-Uosm/Posm), where V is urine volume, Uosm is the urine osmolality, Posm is the plasma sodium osmolality.~Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point – Baseline"|Baseline, Hour 24 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||mL||Standard Deviation|Mean
1253854|NCT00478192|Secondary|Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment|"Effective water clearence (EWC) was calculated as EWC=V(1-(Una+Uk)/(Pna+Pk)), where V is urine volume, Una is the urine sodium concentration, Uk is the urine potassium concentration, Pna is the serum/plasma sodium concentration, an Pk is the serum /plasma potassium concentration.~Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point – Baseline"|Baseline, Hour 12, Hour 24,Hour 36 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||mL||Standard Deviation|Mean
1253855|NCT00478192|Secondary|Baseline –Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours|"Each individual subject's change from baseline serum sodium levels was used to calculate baseline adjusted area under the curve serum sodium levels for a duration of Time 0 to Time t in hours (labeled as AUC(Na)(0-t). The last available serum sodium level prior to dosing on Day 1 was used as baseline.~t=48 Hours"|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.|||Hour * mEq/L||Standard Deviation|Mean
1253856|NCT00478192|Secondary|Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours|Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >6 mEq/L or two consecutive measurements >135 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.|||Patients|||Number
1253857|NCT00478192|Secondary|Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours|Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.|||Patients|||Number
1253858|NCT00478192|Secondary|Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium|"Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~The endpoint was not evaluable in the placebo arm (median and interquartile range cannot be estimated) or the conivaptan QD arm (interquartile range cannot be estimated) because too high a percentage of patients were censored for the event. Only the conivaptan BID arm will be reported."|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.|||Hours||Inter-Quartile Range|Median
1253859|NCT00478192|Secondary|Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment|"Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point - Baseline"|Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||mEq/L||Standard Deviation|Mean
1253860|NCT00478192|Primary|Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.|"Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Hour 48 - Baseline."|Baseline and 48 hours|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||mEq/L||Standard Deviation|Mean
1253861|NCT00478140|Secondary|Overall Survival|Length of time from date of starting treatment that participants are still alive|Up to 3.5 years|||||||
1253862|NCT00478140|Secondary|Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record.|Up to 3 years|||||||
1253864|NCT00478140|Primary|Objective Response (Complete and Partial Response)|Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 63 days or until disease progression|Only those participants who had measurable disease present at baseline, received at least one cycle of therapy, and had disease re-evaluated considered evaluable for response; therefore one participant was inevaluable.|||participants|||Number
1253865|NCT00478062|Primary|Safety and Tolerability||After administration of last vaccine at 9 weeks|The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.||||||
1253866|NCT00478062|Primary|Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses||2 years|The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.||||||
1253867|NCT00478062|Primary|Durability of Immunologic Response||2 years|The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.||||||
1253868|NCT00478062|Primary|Immunologic Response||9 months|The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.||||||
1253869|NCT00478036|Primary|Interocular Pressure|IOP, measured by Goldmann applanation tonometry|8 weeks|Reported for subjects for whom all IOP values were available for all of the visits.|||mmHg||Standard Deviation|Mean
1253870|NCT00478023|Secondary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0)."|Baseline value to 48 hours after first study drug intake.|Intention to treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment.|||units on scale||Standard Deviation|Mean
1253871|NCT00478023|Primary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.|"Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0)."|Baseline to 24 hours after first intake of study drug|Intention to Treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment.|||units on scale||Standard Deviation|Mean
1253872|NCT00477971|Post-Hoc|3-Year Progression Free Survival|"Percentage of patients who were progression free at 3 years. The 3-year progression free rate was estimated using the Kaplan Meier method.~Progression is assessed when one of the following occur:~reappearance of monoclonal protein by immunofixation,~Increase in serum monoclonal paraprotein to >25% above the lowest response level,~Increase in urine M-protein to > 25% above the lowest remission value for 24-hour excretion."|3 years||||percentage of participants||95% Confidence Interval|Number
1253873|NCT00477971|Secondary|Organ Response to Treatment|"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.~Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%."|10 years||||percentage of participants||95% Confidence Interval|Number
1253874|NCT00477971|Secondary|3 Year Overall Survival|Percentage of patients who were alive at 3 years. The 3-year survival rate was estimated using the Kaplan Meier method.|3 years||||percentage of participants||95% Confidence Interval|Number
1253875|NCT00477971|Primary|Hematologic Response Rate|"Response that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response.~Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response (VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response (PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|10 years||||percentage of participants||95% Confidence Interval|Number
1253876|NCT00477750|Secondary|Patients With Grade 3 or Higher Adverse Events|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.|Every cycle during treatment|||||||
1253877|NCT00477750|Secondary|Duration of Response (DOR)|Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation.|from first response to progression or death (up to 3 years)|||||||
1253880|NCT00477750|Primary|Patients With Overall Confirmed Response|"Response that was confirmed on 2 consecutive evaluations. >~Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow >~Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours >~Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells"|Every cycle during treatment||||participants|||Number
1253881|NCT00477685|Primary|Preoperative and Postoperative Intraocular Pressure|The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.|baseline and 90 days||||mm Hg||Standard Deviation|Mean
1253882|NCT00477685|Secondary|Number of Participants With Any Complications or Adverse Events.|Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.|180 day||||participants|||Number
1253883|NCT00477672|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|"This is the Per Protocol population, which includes subjects in the ITT analysis set, who were free of important protocol deviations, as defined before database lock and unblinding. Subjects were analyzed according to the treatment actually received."|||Score on UPDRS-II+III||95% Confidence Interval|Least Squares Mean
1253884|NCT00477672|Primary|Antipsychotic Efficacy|"Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|"This is the Intent to Treat population, defined as patients who received at least one dose of study drug, and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment."|||Score on the SAPS H+D scale||95% Confidence Interval|Least Squares Mean
1253885|NCT00477633|Secondary|Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population|"Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain mean median duration of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated."|12 cycles (28 days each), approximately 336 days|MITT Population|||Days||Standard Deviation|Mean
1253886|NCT00477633|Secondary|Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population||12 cycles (28 days each), approximately 336 days|MITT Population|||Days||Standard Deviation|Mean
1253887|NCT00477633|Primary|Pearl Index, 18-35 Years, MITT Population|Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment|13 cycles (28 days each), approximately 364 days|MITT Population, Subjects Aged 18-35 years|||Pearl Index||95% Confidence Interval|Number
1253888|NCT00477607|Secondary|Total Amount of Prescribed Cisplatin Dose Administered|Maximum cumulative dose of cisplatin (mg/m^2) administered during the course of chemotherapy.|cisplatin treatment period between 10 weeks and up to 16 weeks.|Subjects from the original 39 recruited who had sufficient chemotherapy data recorded to measure cumulative dose.|||mg/m^2||Standard Deviation|Mean
1253889|NCT00477607|Secondary|Malondialdehyde (MDA) Levels|Computed maximum increase relative to baseline for each subject = (max MDA during treatment) - baseline MDA level.|Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.|Non-missing MDA measurements from 23 subjects in primary outcome analysis|||uM=micro-moles/liter||Standard Deviation|Mean
1253890|NCT00477607|Primary|Ototoxicity Measurement|"Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement.~ASHA criteria are defined as~20 decibel (dB) increase at any test frequency,~10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies."|Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.|Intent-to-treat (ITT)|||participants|||Number
1253891|NCT00477594|Other Pre-specified|High-Density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253892|NCT00477594|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol|High-Density Lipoprotein (HDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1264840|NCT00399542|Secondary|Month 1 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1253893|NCT00477594|Other Pre-specified|Apolipoprotein A1 Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253894|NCT00477594|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253895|NCT00477594|Other Pre-specified|Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||ratio||Inter-Quartile Range|Median
1253896|NCT00477594|Other Pre-specified|Percent Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol||Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253897|NCT00477594|Other Pre-specified|Very-Low-Density Lipoprotein (VLDL) Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253898|NCT00477594|Other Pre-specified|Percent Change From Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol|Very-Low-Density Lipoprotein (VLDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253899|NCT00477594|Other Pre-specified|Lipoprotein(a) Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253900|NCT00477594|Other Pre-specified|Percent Change From Baseline in Lipoprotein(a)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253901|NCT00477594|Other Pre-specified|Triglycerides Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253902|NCT00477594|Other Pre-specified|Percent Change From Baseline in Triglycerides|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253903|NCT00477594|Secondary|Percent Change From Baseline in Respiratory Rate||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set|||percentage of baseline||Standard Deviation|Mean
1253904|NCT00477594|Secondary|Percent Change From Baseline in Pulse Rate||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set|||percentage of baseline||Standard Deviation|Mean
1253905|NCT00477594|Secondary|Percent Change From Baseline in Blood Pressure||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set|||percentage of baseline||Standard Deviation|Mean
1253906|NCT00477594|Secondary|Percent Change From Baseline in Hematology Parameters||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment|Safety set|||percentage of baseline||Standard Deviation|Mean
1253907|NCT00477594|Secondary|Percent Change From Baseline in Clinical Chemistry Parameters||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set.|||percentage of baseline||Standard Deviation|Mean
1287956|NCT00147290|Secondary|Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF||one year|||||||
1253908|NCT00477594|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs)|AEs were considered as related if assessed by the Investigator as possibly, probably or definitely related to study drug. The severity of each event was assessed using the following categories: Mild (symptom(s) barely noticeable to the patient or do not make the patient uncomfortable); Moderate (symptom(s) of a sufficient severity to make the patient uncomfortable, performance of daily activities is influenced) or Severe (symptom(s) of a sufficient severity to cause the patient severe discomfort, may cause cessation of treatment with the study drug). Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|2 years|Safety set|||participants|||Number
1253909|NCT00477594|Secondary|Non-High-Density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253910|NCT00477594|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253911|NCT00477594|Secondary|Total Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253912|NCT00477594|Secondary|Percent Change From Baseline in Total Cholesterol|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253913|NCT00477594|Secondary|Apolipoprotein B Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253914|NCT00477594|Secondary|Percent Change From Baseline in Apolipoprotein B|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253915|NCT00477594|Primary|Low-density Lipoprotein Cholesterol (LDL-C) Over Time|Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
1253916|NCT00477594|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
1253938|NCT00477464|Secondary|Terminal Elimination Half-life (t1/2) of Lapatinib|Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr||95% Confidence Interval|Geometric Mean
1253917|NCT00477490|Secondary|Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II|A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.|Week 5 up to Day 169|Part II Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part II.|||participants|||Number
1253918|NCT00477490|Secondary|Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I|A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.|Day 1 up to Week 4 (end of Part I)|Part I Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part I.|||participants|||Number
1253919|NCT00477490|Secondary|Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4|The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.|||units on a scale||Standard Deviation|Mean
1253920|NCT00477490|Secondary|Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4|The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.|||units on a scale||Standard Deviation|Mean
1253921|NCT00477490|Secondary|Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4|The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.|||units on a scale||Standard Deviation|Mean
1253922|NCT00477490|Secondary|Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4|The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.|||units on a scale||Standard Deviation|Mean
1253923|NCT00477490|Secondary|Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4|Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|ITT population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants with both baseline and Week 4/Day 28/End of Part I data are included.|||minutes||Standard Deviation|Mean
1253924|NCT00477490|Secondary|Part I: Change From Baseline in Total Reported Sleep Time at Week 4|Total sleep time was recorded by participants in study diaries.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants analyzed had baseline and Week 4/Day 28/End of Part 1 measurements.|||minutes||Standard Deviation|Mean
1253925|NCT00477490|Secondary|Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169|Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.|- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169|Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations. Participants had data representing the visit.|||percentage of participants|||Number
1253926|NCT00477490|Secondary|Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169|Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries.|- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169|Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations.|||nocturnal voids||Standard Deviation|Mean
1253939|NCT00477464|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of lapatinib dosing.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr||95% Confidence Interval|Geometric Mean
1253927|NCT00477490|Primary|Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4|"Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.~This was the second co-primary outcome."|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset|||percentage of participants|||Number
1253928|NCT00477490|Primary|Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4|"The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries.~This was the first co-primary outcome."|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset|||nocturnal voids||Standard Deviation|Mean
1253929|NCT00477464|Secondary|Trough Concentration of Capecitabine, 5-FU, and FBAL|PK samples were collected at pre-dose on Day 14 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|ITT Population. Evaluable samples were not taken from some participants.|||ng/ml||Standard Deviation|Mean
1253930|NCT00477464|Secondary|Trough Concentration of Lapatinib|PK samples were collected at pre-dose on Day 14 and Day 21 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose of lapatinib.|Week 2|ITT Population. Evaluable samples were not taken from some participants.|||ng/ml||Standard Deviation|Mean
1253931|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 12 hours after dosing (AUC 0-12). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr*ng/ml||95% Confidence Interval|Geometric Mean
1253932|NCT00477464|Secondary|AUC0-tau of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr*ng/ml||95% Confidence Interval|Geometric Mean
1253933|NCT00477464|Secondary|t1/2 of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr||95% Confidence Interval|Geometric Mean
1253934|NCT00477464|Secondary|Tmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr||95% Confidence Interval|Geometric Mean
1253935|NCT00477464|Secondary|Cmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of drug. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||ng/ml||95% Confidence Interval|Geometric Mean
1253936|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 24 Hours AUC0-24 of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 24 hour after dosing (AUC 0-24). AUC is a measure of exposure.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr*ng/ml||95% Confidence Interval|Geometric Mean
1253937|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve Within the Dosing Interval AUC0-tau of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). AUC is a measure of exposure.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr*ng/ml||95% Confidence Interval|Geometric Mean
1253940|NCT00477464|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib|Pharmacokinetic (PK) samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hours (hr) (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of lapatinib.|Week 2|PK Population: consisted of the first six participants who were enrolled into the study and evaluable for the PK parameters of the investigational products. One participant was excluded due to dose reduction.|||nanograms/milliliter (ng/ml)||95% Confidence Interval|Geometric Mean
1253941|NCT00477464|Secondary|Duration of Response (Independent Reviewer-assessed)|For the subset of participants who showed a complete or partial response, duration of response is defined as the time from the first documented evidence of partial or complete tumor response until the first documented sign of disease progression or death due to breast cancer, if sooner.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|Participants in the ITT Population achieving a partial or complete response|||weeks||95% Confidence Interval|Median
1253942|NCT00477464|Secondary|Time to Response (Independent Reviewer-assessed)|Time to response is defined as the time from the start of treatment until the first documented evidence of complete response or partial response.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|Participants in the ITT Population achieving a partial or complete response|||weeks||95% Confidence Interval|Median
1253943|NCT00477464|Secondary|Overall Survival (Independent Reviewer-assessed)|Overall survival is defined as the time from the start of treatment until death regardless of cause. For participants who did not die, time to death was censored at the time of last confirmation of survival.|Baseline and then followed every 4 weeks until death (up to Week 157.9) while on treatment. After treatment termination, followed every 12 weeks until death (up to Week 157.9)|ITT Population|||weeks||95% Confidence Interval|Median
1253944|NCT00477464|Secondary|Objective Response (Independent Reviewer-assessed)|Objective response is defined as the percentage of participants achieving a best overall response classified as a complete or partial (confirmed) tumor response. Complete response is defined as the disappearance of all target or non-target lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameter of target lesions.|Baseline every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|ITT Population|||percentage of participants|||Number
1253945|NCT00477464|Secondary|6-Month Progression-free Survival (Independent Reviewer-assessed)|6-Month progression-free survival is defined as the percentage of participants surviving without progressive disease at 6 months (24 weeks) after the start of treatment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|Baseline and then every 6 weeks until Month 6 (Week 24)|ITT Population|||percentage of participants|||Number
1253946|NCT00477464|Secondary|Progression-free Survival (PFS) (Independent Reviewer-assessed)|PFS is defined as the interval between the start of treatment and the earliest date of disease progression or death of any cause, if sooner.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|ITT Population|||weeks||95% Confidence Interval|Median
1253947|NCT00477464|Secondary|Time to Progression (Independent Reviewer-assessed)|Time to progression is defined as the interval between the start of treatment and the earliest date of disease progression or death due to breast cancer, if sooner. Time to progression was calculated by using the Kaplan Meier estimate.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death due to breast cancer (up to Week 119)|ITT Population|||weeks||95% Confidence Interval|Median
1253948|NCT00477464|Primary|Clinical Benefit Response (Independent Reviewer-assessed)|"CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A “complete response” is defined as the disappearance of all target or non-target lesions, “partial response” and disease progression as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and “stable disease” as neither “partial response” nor “disease progression.”"|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)|Intent-to-treat (ITT) Population: participants who had received at least one dose of study medication.|||percentage of participants|||Number
1253949|NCT00477451|Secondary|Borg Max Change From Baseline|"Subjects asked to Point to the number (0 to 10) which matches how breathless you feel now where 0=nothing at all to 10=very, very strong"|45 minutes|RCT Population (N=40)|||units on a scale||Standard Deviation|Mean
1253950|NCT00477451|Primary|Duration of the Doxapram-induced Panic Attack|Length of time from the doxapram injection to the time at which the acute panic inventory (API) value returns to within 10 points of the baseline API value. 0=never exceeded 0, 61=exceeded by more than 10 points still at end of assessment of 60 minutes. Thus each would have a duration whether or not they had a panic attack (DIPASI)|1 hr post-dose|RCT Population (N=40)|||minutes||Standard Deviation|Mean
1253951|NCT00477451|Primary|Number of Participants With Doxapram-induced Panic Attack|doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)|0 to 2 hours|RCT Population (N=40)|||Participants|||Count of Participants
1253952|NCT00477386|Secondary|Phase II: Progression Free Survival|Progression free survival times will be estimated using the Kaplan-Meier method. If a patient progresses or dies, the time till that event will be used. If a patient does not progress or die on the study, the patient will be censored at the last available visit. Confidence intervals on the median will be constructed.|Baseline until disease progression or last visit|All Patients in Phase II of the study|||Months||95% Confidence Interval|Median
1253953|NCT00477386|Secondary|Phase II: Percent of Patients With Objective Response, CA125 Response or Stable Disease > 3 Months|The percent of patients having an objective response (Complete Response or Partial Response) or CA125 response (Complete Response or Partial Response) or stable disease > 3 months will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.|screening until end of study (approx 12-18 months)|All Patients in Phase II of the study|||percent of patients||95% Confidence Interval|Number
1255325|NCT00467298|Secondary|Quality of Life|SF-36 PCS. Scale range 0-100, higher scores reflect higher quality of life. PCS=Physical Composite Score. These are not change scores.|6 months|These are not change scores.|||units on a scale||Standard Deviation|Mean
1253954|NCT00477386|Primary|Phase II: Percent of Patients With Objective Response|The percent of patients having an objective response (Complete Response or Partial Response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.|screening until end of study (approx 12-18 months)|All Patients in Phase II of the study|||percent of participants||95% Confidence Interval|Number
1253955|NCT00477386|Primary|Phase I: Maximum Tolerated Dose (MTD) for Use in Phase II|The definition of MTD will follow the standard definition of the phase I 3+3 trial concept. Dose Limiting Toxicities (DLTs) will be scored in the first cycle. Patients will be monitored for 28 days (a cycle) to determine whether a DLT is experienced for the specific dose level.|28 days|All patients assigned to Phase I of the study|||mg/m2 IV QD x 5 days|||Number
1253956|NCT00477334|Secondary|The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment|"The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.~SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)"|Baseline, Day 2|304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.|||Participants|||Number
1253957|NCT00477334|Secondary|The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment|The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.|Baseline, Day 2|304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.|||Participants|||Number
1253958|NCT00477334|Secondary|Time to Second Recurrence of Genital Herpes|Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.|6 months|Intent to Treat Population: participants who completed the first recurrence.|||Days||Inter-Quartile Range|Median
1253959|NCT00477334|Secondary|Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period|Number of participants with a second recurrence of genital herpes in the follow-up period.|6 months|Intent to Treat Population: participants who completed the first recurrence.|||Participants|||Number
1253960|NCT00477334|Secondary|Time to Resolution of Symptoms Associated With Recurrent Genital Herpes|Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.|72 hour after initiation of study medication up to 21 days|Intent to Treat Population. If a participant never had a symptom prior to the last valid diary entry for the first recurrence, then the time to resolution of the symptom was set to missing and the participant was not included in the analysis.|||Days||Inter-Quartile Range|Median
1253961|NCT00477334|Secondary|Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions|Kaplan-Meier estimation.|21 days|ITT participants who discontinued from the study before healing of non aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non aborted lesion stages and without a final assessment on aborted lesion status were assumed as having non aborted lesions in this analysis.|||Days||Inter-Quartile Range|Median
1253962|NCT00477334|Secondary|Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period||21 days|Intent-to-Treat (ITT). All randomized participants who initiated treatment (i.e. received any dose of the study drug) with the intention of treating genital herpes recurrences.|||Percentage of Participants|||Number
1253963|NCT00477334|Primary|Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions|Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).|21 days|Modified Intent to Treat Population (mITT) that includes all Intent to Treat participants with non-aborted genital herpes lesions during the treatment period.|||Days||Inter-Quartile Range|Median
1253964|NCT00477295|Secondary|Percentage of Participants With EQ-5D Scores at Maintenance Period Visit 1|The European Quality of Life Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a preference based generic health related quality of life (HRQoL) instrument which classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels, they are (1) no problems, (2) some problems, (3) extreme problems. The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score.|Week 31 through Week 83|Intent-to-Treat Population. This was measured using Observed Case (OC). The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score (n=174,196).|||Percentage of Participants|||Number
1253965|NCT00477295|Secondary|Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1|The Short Form 36 Health and Well-Being Questionnaire (SF-36) is a 36-item generic health related QOL instrument covering the following domains: physical functioning, role-physical,bodily pain, general health, social functioning,role-emotional, mental health, and vitality. It yields a profile of eight scores, one for each domain, and physical and mental health summary measures. Each domain is described by a score ranging from 0 to 100, for a range of total possible scoes of 0-400 for physical and 0-400 for mental. An increase represents an improvement, whereas a decrease reflects a worsening.|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).|||Scores on a Scale||Standard Deviation|Mean
1254012|NCT00477152|Primary|Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success|Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination|At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)|||participants|||Number
1253966|NCT00477295|Secondary|Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1|"The Quality of Life in Epilepsy - Problems(QOLIE-31-P) was completed by the patient and contained 30 items covering seven subscales(seizure worry, overall~Quality of Life (QOL),emotional well-being,energy-fatigue, cognition,medication effects and social function) and one item covering health status. It also included seven items addressing overall distress related to each subscale, an item addressing the relative importance of each subscale topic, and an item addressing perception of overall change in QOL at the end of the study. A high score reflects a good QOL. The following scale range is a sample of 1 of the 7 of the subscales:~10 (Best possible quality of life) - 0 (Worst possible quality of life);~Rand Corporation QOLIE-31 Scoring Manual was used. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing overall all scales."|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).|||Scores on a Scale||Standard Deviation|Mean
1253967|NCT00477295|Secondary|Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1|"The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line.~Subjects were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria."|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).|||Scores on a Scale||Standard Deviation|Mean
1253968|NCT00477295|Secondary|Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1|The Aldenkamp-Baker Neuropsychological Assessment Scale(ABNAS) is a subject based questionnaire to measure subjective perceived drug-related cognitive impairments. The ABNAS measured seven critical domains of cognition(tiredness/fatigue,hyperexcitability, slowing(mental and motor),memory impairment,attention disorders,impairment of motor coordination, and language disorders). The total score ranged from 0 to 72, with a higher score reflecting a high level of problems.|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication. This was measured using Observed Case (OC).|||Scores on a Scale||Standard Deviation|Mean
1253969|NCT00477295|Secondary|Time to 12-months Seizure Freedom|A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 83|ITT Population|||Days||Standard Deviation|Mean
1253970|NCT00477295|Secondary|Time to 6-months Seizure Freedom|A subject achieved a 6-months seizure-free period if they were free of all seizures, regardless of seizure type, for 6-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 83|Intent-to-Treat (ITT) Population - randomized subjects who received at least one dose of study medication.|||Days||Standard Deviation|Mean
1253971|NCT00477295|Secondary|Analysis of Time to Drop Out Due to Lack of Efficacy|Lack of efficacy was evaluated by the subject and on the basis of whether zonisamide and carbamazepine gave the subject at least a 26-week seizure free rate. The subject could withdraw at any time due to lack of efficacy.|Week 1 through Week 109|Per Protocol Population|||Median Days||Standard Error|Median
1253972|NCT00477295|Secondary|Analysis of Time to Drop Out Due to an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a subject and does not necessarily have a causal relationship with the medicinal product. Adverse events were identified by: any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medicinal product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of laboratory values or other clinical test; and recurrence of an intermittent medical condition not present at Baseline.|Week 1 through Week 109|Per Protocol Population|||Median Days||Standard Error|Median
1253973|NCT00477295|Secondary|Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period|A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12 months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 109|Per Protocol Population. N=number of subjects with evaluable data.|||Percentage of participants|||Number
1253974|NCT00477295|Primary|Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase|A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 31 through Week 109|Per Protocol Population: All randomized subjects who received at least one dose of study medication and who had no major protocol violations.|||Percentage of Participants|||Number
1253975|NCT00477269|Secondary|Blood Gas Measurement - pH at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including pH levels at baseline and Study completion Week 24. The pH scale measures how acidic or basic a substance is. It ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||pH scale||Standard Deviation|Mean
1253976|NCT00477269|Secondary|Blood Gas Measurement - Venous Saturation at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Venous Saturation levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||percentage of saturation||Standard Deviation|Mean
1254013|NCT00477152|Primary|HYLENEX-facilitated Subcutaneous (SC) Rehydration Success|Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home|At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)|||participants|||Number
1253977|NCT00477269|Secondary|Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Arterial Saturation levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||percentage of saturation||Standard Deviation|Mean
1253978|NCT00477269|Secondary|Blood Gas Measurement - PvO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PvO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1253979|NCT00477269|Secondary|Blood Gas Measurement - PaCO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaCO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1253980|NCT00477269|Secondary|Blood Gas Measurement - PaO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1253981|NCT00477269|Secondary|Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. SVR was calculated according to the equation: SVR = (Paorta – Pright atrium)/CO|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||dyn*s/cm^5||Standard Deviation|Mean
1253982|NCT00477269|Secondary|Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. PVR calculated according to the equation:PVR = (PAP – PCWP)/CO|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||dyn*s/cm^5||Standard Deviation|Mean
1253983|NCT00477269|Secondary|Mean Cardiac Output (CO) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||L/min||Standard Deviation|Mean
1253984|NCT00477269|Secondary|Mean Heart Rate (HR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Heart Rate (HR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
1253985|NCT00477269|Secondary|Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systolic Arterial Pressure (SAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1253986|NCT00477269|Secondary|Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Arterial Wedge Pressure (PAWP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1254014|NCT00477087|Secondary|Overall Survival (OS)|Assessed as the time from the 1st dose of study drug to death.|18 months||||Months||Full Range|Median
1254015|NCT00477087|Secondary|Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)|Defined as the first evidence of a total serum PSA decline of > 50% from baseline, maintained for at least 28 days, and confirmed with 2 consecutive measurements taken 2 weeks apart.|18 months||||Participants|||Count of Participants
1253987|NCT00477269|Secondary|Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1253988|NCT00477269|Secondary|Borg Score During the Six Minutes Walk Test at Different Time Periods|Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1253989|NCT00477269|Secondary|Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
1253990|NCT00477269|Secondary|Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1253991|NCT00477269|Secondary|Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1253992|NCT00477269|Secondary|Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||Percentage of Oxygen Saturation||Standard Deviation|Mean
1253993|NCT00477269|Secondary|Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity|PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||number of participants|||Number
1253994|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||minutes||Standard Deviation|Mean
1253995|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||number of stops||Standard Deviation|Mean
1253996|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||meters||Standard Deviation|Mean
1253997|NCT00477269|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension|In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.|72 months|No formal statistical analysis was performed in the extension phase of this study so no analysis data sets were defined. All summaries are based on all patients enrolled.|||participants|||Number
1253998|NCT00477269|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core|In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.|6 months|Safety Population all participants enrolled was included in this population|||participants|||Number
1253999|NCT00477230|Primary|Freedom for Symptomatic Episode of Atrial Fibrillation at One Year||One Year|Early study termination before one year.|||participants|||Number
1254000|NCT00477204|Secondary|No Secondary Outcomes|No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.|6 months|||||||
1254001|NCT00477204|Primary|Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.|Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.|Baseline to 6 months|Recruitment for this study failed to meet target. Due to the small sample size the analyses of these data were primarily descriptive.|||mg/dl||Standard Deviation|Mean
1254002|NCT00477191|Secondary|Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.|Analyzing the safety and tolerability of Etanercept which is being measured through the number of adverse events related to Entanercept over a 6-month period.|6 months||||number of events|||Number
1254003|NCT00477191|Secondary|Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months|Reactive hyperemia index (RHI) is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post –to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction. The possible range of scores is 1 to 3 and a lower score has a worse outcome.|6 months||||units on a scale||Standard Deviation|Mean
1254004|NCT00477191|Secondary|Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome|Analyzing the difference in plasma glucose in subjects with Psoriasis and Metabolic Syndrome between baseline and month 6.|6 months||||mg/dl||Standard Deviation|Mean
1254005|NCT00477191|Primary|Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome|Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome|6 months||||ng/mL||Standard Deviation|Mean
1254006|NCT00477165|Secondary|Urgency Score as a Function of Distending Pressure at the End of the Study|A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second. After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated urgency for bowel movement 30 seconds into each inflation. Urgency score scale: 0=no urgency, 1=threshold urgency, 5=worst imaginable urgency.|Week 8|Participants with available data were included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1254007|NCT00477165|Secondary|Mean Sensation Score as a Function of Distending Pressure at the End of the Study|A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second. After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated sensation 30 seconds into each inflation. Sensation score scale: 0=no inflation sensation, 1-5=increasing painless sensation, 6=threshold pain, 10=worst imaginable pain.|Week 8|Participants with available data were included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1254008|NCT00477165|Secondary|Change From Baseline in IBS-QOL Score at Week 8|The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL consists of 34 statements about bowel problems, each with a five-point response scale ranging from 1 (no problems) to 5 (most problems). The individual scores are summed and averaged for a total score, then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life.|Baseline; Week 8||||units on a scale||95% Confidence Interval|Mean
1254009|NCT00477165|Primary|"Count of Participants Who Self-reported Adequate Relief"|Participants were asked weekly to answer subjectively whether weekly adequate relief from IBS symptoms was achieved. Overall response was defined as having achieved adequate relief in at least 3 of the past 6 weeks.|Baseline, weekly for 8 weeks||||Participants|||Count of Participants
1254010|NCT00477152|Secondary|Post-treatment Gorelick Dehydration Score|Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.|At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)|||No. moderate/severe symptoms (max = 10)||Standard Deviation|Mean
1254011|NCT00477152|Secondary|Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter||At end of placement of SC catheter|ITT (all treated patients)|||participants|||Number
1254016|NCT00477087|Primary|Progression-free Survival (PFS)|Assessed as the time from the 1st dose of study drug to death or disease progression (increase >25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of >20% KPS)|18 months||||weeks||Full Range|Median
1254017|NCT00476957|Secondary|Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions|Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions|3 years||||participants|||Number
1254018|NCT00476957|Primary|To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation|Definite or probable stent thrombosis rate.|3 years||||participants|||Number
1254019|NCT00476827|Secondary|To Assess the Quality of Life During Treatment With This Therapeutic Approach|Due to slow accrual study was prematurely closed and endpoint not analysed|8 to 9 weeks|||||||
1254020|NCT00476827|Primary|Determining the Safety and Tolerability of Adding Avastin to Single Agent Chemotherapy to Treat Patients With Brain Metastasis Originating From Breast Cancer|Due to slow accrual study was prematurely closed and endpoint not analysed|trial closure|Due to slow accrual study was prematurely closed and endpoint not analysed||||||
1254021|NCT00476827|Secondary|Assess the Activity of Avastin When Added to Single Agent Chemotherapy, as Measured by Radiographic Response Rate,Progression Free Survival, and Overall Survival.|Due to slow accrual study was prematurely closed and endpoint not analysed|8 to 9 weeks|Due to slow accrual study was prematurely closed and endpoint not analysed||||||
1254022|NCT00476827|Primary|Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria.|Primary endpoint has not been analysed secondary to slow and low accrual numbers.|May 2009|Endpoint has not been analysed secondary to slow and low accrual numbers.||||||
1254023|NCT00476788|Primary|Mean Glycated Hemoglobin (A1c)|Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.|6.9 months (average)||||percentage of glycated hemoglobin||Standard Deviation|Mean
1254024|NCT00476788|Secondary|Number of Reported Adverse Events|adverse events are defined as a change from baseline|6.9 months (average)||||events|||Number
1254025|NCT00476645|Secondary|Stable Disease After One Year|Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria.|12 months||||participants|||Number
1254026|NCT00476645|Secondary|PSA Doubling Time|Number of subjects with prolongation of PSA doubling time|3 months||||participants|||Number
1254027|NCT00476645|Primary|PSA Reduction ≥ 50%|Number of subjects with serum PSA reduction ≥ 50% at 3 months|3 months|All subjects (10 males) had castration-resistant prostate cancer. 6 had recieved prior radical prostatectomy as primary therapy. 4 had received prior chemotherapy. The majority had previously received 2 hormonal therapies. 2 had recieved radiation therapy, and 2 had recieved hormonal monotherapy.|||participants|||Number
1254028|NCT00476593|Primary|Macular Thickness Measured With the OCT; in Relation to Age, Sex, Reproductive Factors and the Use of Anti-inflammatory Eye Drops in Health; in Uncomplicated Anterior Uveitis.|Macular thickness was assessed with the OCT in healthy subjects and in patients with anterior uveitis. Data was analyzed with respect to age, sex, parity, the use of hormonal therapy, after treatment with to types of anti-inflammatory eye drops, and in uncomplicated uveitis.|Macular thickness measured with the OCT|Enrolled healthy subjects and patients with anterior uveitis who volunteered through enrollment period|||Macular Thickness in micron||Standard Deviation|Mean
1254029|NCT00476476|Primary|Response Rate|Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).|Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).|The analysis dataset is comprised of response evaluable patients.|||proportion of participants||90% Confidence Interval|Number
1254030|NCT00476242|Secondary|Opiate Craving Based on Heroin Craving Scale|Range 0- 100 ( 0= no craving; 100= very strong craving|Average of twice weekly assessments for 12 weeks of study or length of participation||||units on a scale||Standard Deviation|Mean
1254031|NCT00476242|Primary|Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no).||Week 12||||participants|||Number
1254032|NCT00476242|Primary|Opiate Use Measured by Urine Toxicology Results|Opiate use was qualified by the number of opiate positive urine results.|3x/week during 12 weeks of the trial or study participation||||Percent of total urine samples||Inter-Quartile Range|Median
1254033|NCT00476229|Primary|Composite Success Rate|Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Baseline to Day 100, assessment at Day 100|Analysis was per protocol. One participant was inevaluable.|||Percentage of participants|||Number
1254034|NCT00476151|Primary|Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.|diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.|baseline and 4 weeks treatment|ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation|||units on a scale||95% Confidence Interval|Least Squares Mean
1254111|NCT00475657|Secondary|Overall Survival|Trial terminated - results not analyzed|baseline to date of death from any cause||||participants|||Number
1254112|NCT00475657|Primary|Overall Response Rate|Trial terminated - results not analyzed|baseline to measured progressive disease||||participants|||Number
1254035|NCT00476086|Secondary|Radiation Therapy Completion Rate|Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease|Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.|The analysis dataset is comprised of all participants who started chemotherapy.|||percentage of participants||90% Confidence Interval|Number
1254036|NCT00476086|Primary|Chemotherapy Completion Rate|Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.|3 cycles of chemotherapy which approximates 3 months given the 28-day cycle|The analysis dataset is comprised of all participants who started chemotherapy.|||percentage of participants||90% Confidence Interval|Number
1254037|NCT00476047|Secondary|Evaluate Toxicities of 131I-tositumomab|Adverse events following treatment of 131I-tositumomab|48 months (median)||||participants with this toxicity|||Number
1254038|NCT00476047|Primary|Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy||3 months after 131I-tositumomab consolidation||||Participants|||Count of Participants
1254039|NCT00476047|Primary|Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy|Response rates determined using National Cancer Institute (NCI) working group guidelines plus computed tomography (CT) scan criteria. Participants were assessed for response after initial chemotherapy and again 3 months after 131I-tositumomab treatment.Only patients who had less than a complete response (CR) after initial chemotherapy were assessed for improved response after 131I-tositumomab.|3 months after 131I-tositumomab consolidation|Participants who had a partial response (PR) after initial chemotherapy. Response assessed using NCI working group guidelines + CT criteria as described in the protocol.|||Participants|||Count of Participants
1254040|NCT00476047|Primary|Probability of Progression-free Survival (PFS)|Progression free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression. This outcome measures the percentage of participants with PFS at 36 months.|36 months||||percentage probability||95% Confidence Interval|Number
1254041|NCT00476021|Secondary|Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion||6 months||||participants|||Number
1254042|NCT00476021|Secondary|Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates||6 months||||participants|||Number
1254043|NCT00476021|Secondary|Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography||6 months|The population only includes women who received IUDs at the specified timepoint. Only 50/51 women in the postplacental group had a successful IUD insertion postplacentally. Only 46 of 51 women in the delayed group returned for a delayed IUD insertion.|||participants|||Number
1254044|NCT00476021|Secondary|Follow-up Rates for Delayed Insertion of LNG-IUD||6 months||||participants|||Number
1254045|NCT00476021|Secondary|Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement||6 months||||participants|||Number
1254046|NCT00476021|Primary|IUD Usage Rate at 6 Months|Usage rate of the LNG-IUD at 6 months after delivery|6 months after delivery|IUD use at 6 months, lost to follow-up counted as failures|||participants|||Number
1254047|NCT00476008|Secondary|Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|The ADAS-Cog is a performance based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's disease. The cognitive subscale comprises 11 items which measure word recall (0-10), ability to follow single and multi-step commands (0-5), constructional praxis (0-5), ideational praxis (0-5), naming objects(0-5), word recognition (0-12), orientation (0-8), comprehension of spoken language (0-5), word finding difficulty(0-5) and ability to remember test instructions (0-5). 0 = no impairment with higher scores indicating more severe impairment.|baseline and 12 months||||units on a scale||Standard Deviation|Mean
1254048|NCT00476008|Secondary|Cognitive Dementia Rating Scale|This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe.|baseline and 12 months||||units on a scale||Standard Deviation|Mean
1254049|NCT00476008|Secondary|Motor Free Visual Perception Test - Visual Closure Subtest|This is an 11 item multiple choice test of visual perception. Scores range from 0-11. This test measures visual perception deficits separate from motor skill abilities. Higher scores indicate more severe impairment.|baseline and 12 months||||number incorrect||Standard Deviation|Mean
1254050|NCT00476008|Secondary|Useful Field of View|The Useful Field of View is a computer-administered test that measures higher order processing skills such as divided attention and visual processing speed. Scores can be predictive of ability to perform many everyday activities, such as driving a vehicle. Speed of visual processing is measured as the examinee identifies a target, but must also localize a simultaneously presented target displayed in the periphery of the computer monitor. Scores range from 1 to 4 with 1 being no impairment, 2= mild, 3= moderate and 4=serious impairment.|baseline and 12 months||||units on a scale||Standard Deviation|Mean
1254051|NCT00476008|Secondary|Mini Mental Status Exam|Scores range from 0-30 with lower scores indicating decreased functioning.|baseline and 12 months||||units on a scale||Standard Deviation|Mean
1254052|NCT00476008|Secondary|Trail Making Test - Part B|This tests cognitive flexibility and set-shifting. It is considered to be a test of executive functioning and has been shown to correlate with on-road driving ability. The score is the time in seconds required to complete each part. Higher scores indicate decreased functioning.|baseline and 12 months||||seconds||Standard Deviation|Mean
1254053|NCT00476008|Secondary|Trail Making Test - Part A|A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning.|baseline and 12 months||||seconds||Standard Deviation|Mean
1254054|NCT00476008|Secondary|Rey Complex Figure Test|This is a measure of visual-spatial and constructional ability as well as higher order cognitive processes including planning, organizing, and problem solving. Subjects are asked to copy a complicated drawing. 18 elements are scored from 0-2 depending on accuracy/distortion and location of the reproduction. The maximum score is 36 points. Lower scores indicate more severe impairment|baseline and 12 months||||units on a scale||Standard Deviation|Mean
1254055|NCT00476008|Secondary|Fuld Object Memory Evaluation|"Ten common objects in a bag were presented to determine whether the subject could identify objects by touch. The subject was not told that memory of this event would be tested. The subject names each object and then pulls it out of the bag to see if he is correct. After distracting the subject, by asking the patient to say words rapidly from a single category (rapid verbal retrieval), the subject is asked to recall the objects from the bag. The subject was then offered two more chances to learn and recall them (store and retrieve) by reminding the subject of omitted items after each recall, with rapid verbal retrieval preventing rehearsal before each recall opportunity.~Retrieval scores were summed over the three trials with the range of possible scores being 0-30. Lower scores indicate more severe impairment."|baseline and 12 months||||units on a scale||Standard Deviation|Mean
1254056|NCT00476008|Primary|The Primary Outcome Measure is the Number of Subjects in Each Group Who Are Able to Pass the DriveABLE On-Road Test at Month 12 (Endpoint).|The DriveABLE On-Road Test utilizes a standardized road course and standardized scoring procedures designed to identify driving errors indicative of decline in competence scores. This road test takes approximately 30-45 minutes and covers a distance of approximately 9 miles.|Baseline and 12 months|One subject in the placebo group could not complete the driving test at 12 months due to his vision being below the legal limit to drive.|||participants|||Number
1254057|NCT00475904|Primary|Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin|Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.|baseline to 28 Days|Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique|||units on a scale||95% Confidence Interval|Least Squares Mean
1254058|NCT00475904|Primary|Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.|Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.|baseline and 28 days|This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach.|||units on a scale||95% Confidence Interval|Mean
1254059|NCT00475878|Secondary|Depressive Symptoms|Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.|3 months|participants who were fully eligible for the study, completed the enrollment process and began study medication were included in an intent to treat analysis|||units on a scale||Standard Error|Mean
1254060|NCT00475878|Primary|Percentage of Participants Who Dropped Out of Buprenorphine Treatment|Drop-out is defined as 7 or more days of missed Buprenorphine doses|3 months|Participants who were fully eligible for the study, completed the enrollment process and began study medication were used in an intent to treat analysis.|||percentage of participants|||Number
1254061|NCT00475865|Secondary|Pharmacokinetic [PK]: Teriflunomide Plasma Concentration|Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.|24 weeks|All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.|||micrograms/mililiter (μg/mL)||Standard Deviation|Mean
1254062|NCT00475865|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group and region of enrollment as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||relapses per year||95% Confidence Interval|Number
1254063|NCT00475865|Secondary|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters per scan|||Number
1254064|NCT00475865|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||lesions per scan||95% Confidence Interval|Number
1254065|NCT00475865|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors)."|baseline (before randomization) and 24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters (mL)||Standard Error|Least Squares Mean
1255326|NCT00467298|Primary|Function Capability|6MWT-Six Minute Walk Test|6 months||||meters||Standard Deviation|Mean
1254066|NCT00475865|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1254067|NCT00475865|Primary|Overview of AE With Potential Risk of Occurrence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly hair loss and hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1254068|NCT00475865|Primary|Overview of Adverse Events (AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1254069|NCT00475852|Other Pre-specified|Number of Patients With Renal Impairment|Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.|Study drug initiation to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.|||Participants|||Number
1254070|NCT00475852|Other Pre-specified|Cardiovascular Mortality Through Day 30|All deaths were adjudicated by an independent Clinical Events Committee (CEC) and the cardiovascular deaths were classified by the CEC based on the primary causes.|Randomization to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.|||Participants|||Number
1254071|NCT00475852|Other Pre-specified|All-Cause Mortality Through Day 180|All deaths were adjudicated by an independent Clinical Events Committee.|Randomization to Day 180|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.|||Participants|||Number
1254072|NCT00475852|Other Pre-specified|All-Cause Mortality Through Day 30|All deaths were adjudicated by an independent Clinical Events Committee.|Randomization to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.|||Participants|||Number
1254073|NCT00475852|Secondary|Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 162 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
1254074|NCT00475852|Secondary|Number of Days Alive and Outside the Hospital||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 182 and 188 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Days||Standard Deviation|Mean
1254075|NCT00475852|Secondary|Composite of Persistent or Worsening Heart Failure and All-Cause Mortality|Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure.|Randomization to hospital discharge (up to Day 30)|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 105 and 115 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
1254076|NCT00475852|Secondary|Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug|Overall well-being was measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|24 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 200 and 194 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
1254125|NCT00475501|Secondary|Geriatric Depression Scale|"Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment.~The minimum score is 0 = no depressive symptoms The maximum score is 15 = a very high level of depressive symptoms"|baseline, 3 months, 6 months, 9 months, 12 months||||units on a scale||Standard Error|Mean
1254077|NCT00475852|Secondary|Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug|Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|6 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 158 and 147 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
1254078|NCT00475852|Primary|Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug|Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|24 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 193 and 179 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
1254079|NCT00475852|Primary|Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug|Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|6 hours after initiation of study drug|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 148 and 133 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
1254080|NCT00475852|Primary|Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 164 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
1254081|NCT00475787|Secondary|Medical Outcome Study Short Form Physical Functioning Subscale|For the Physical Functioning subscale, the higher the number the less self-reported limitations in physical function. The computed SF-36 physical function subscale scores range from 2 to 12.|baseline and 5 weeks||||percentage of change||95% Confidence Interval|Mean
1254082|NCT00475787|Secondary|Performance of the Timed up and go Test|The Timed Up and Go Test assesses the amount of time it takes an individual to rise from a standard arm chair, walk a distance of 3 meters, and return to the initial position resting against the back of the chair, in this case the measurement was performed utilizing lasers to assess the time to the three meter mark and also the return to sitting in the chair.|baseline and 5 weeks||||percentage of change||95% Confidence Interval|Mean
1254083|NCT00475787|Secondary|Oswestry Disability Index (ODI)|Validated measure of disability associated with lower back pain.|baseline and 5 weeks||||percentage of change||95% Confidence Interval|Mean
1254084|NCT00475787|Secondary|Medical Outcome Study Short Form 36(SF-36) Bodily Pain|For the Bodily pain subscale, the higher the number the less self-reported pain. The computed SF-36 pain subscale scores range from 2 to 12.|baseline and 5 Weeks||||percentage of change||95% Confidence Interval|Mean
1254085|NCT00475787|Primary|Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)|"100 mm line with 0 being no pain and 100 mm being the worst pain I can imagine."|Baseline, 5 weeks||||percentage of change from baseline to 5||95% Confidence Interval|Mean
1254086|NCT00475735|Secondary|Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score|"The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment|||||||
1254087|NCT00475735|Secondary|Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.|"Conners' Adult ADHD Rating Scale – Observer Screening version (CAARS-O: SV) evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. It is a 30-item scale administered by a trained investigator or rater with cue questions. Each item is scored from 0 to 3 with higher scores corresponding to worse symptoms. The total score can range from 0 to 90.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment|||||||
1254088|NCT00475735|Secondary|Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score|"The Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) hyperactive/impulsive subscale score consists of 9 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.~Data not reported due to failure of primary hypothesis and program termination"|4 weeks of treatment|||||||
1254089|NCT00475735|Secondary|>/=1-point Improvement in the CGI-S Score|"The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment|||||||
1254126|NCT00475501|Secondary|Lumbar Spine L2-L4 Bone Mineral Density|Dual x-ray absorptiometry (DXA): We will assess bone mineral density (BMD) and body composition using a fan-bean densitometer (Lunar Prodigy, General Electric Medical Systems).|baseline, 12 months||||gm/cc||Standard Error|Mean
1287957|NCT00147290|Secondary|Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT||one year|||||||
1254090|NCT00475735|Secondary|>/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;|"The AISRS total score consists of 18 items from the original ADHD-RS which were derived based on DSM-IV criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.~Data not reported due to failure of primary hypothesis and program termination."|after 4 weeks of treatment|||||||
1254091|NCT00475735|Other Pre-specified|Baseline AISRS|"Baseline values for all treatment groups are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhyā: The Indian Journal of Statistics, Series B 62, 134–148)."|Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.|||score on scale||Standard Error|Least Squares Mean
1254092|NCT00475735|Secondary|Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment|"The AISRS inattentive subscale score consists of 9 items from the original ADHD-RS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.~Data not reported due to failure of primary hypothesis and program termination."|after 4 weeks of treatment|||||||
1254093|NCT00475735|Primary|Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment|The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.|after 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.|||score on scale||95% Confidence Interval|Least Squares Mean
1254094|NCT00475722|Primary|Adherence to Dietary Goals|Percentage of participants who met 70% of diet goals as outlined in the exchange list|6 months||||percentage of participants meeting goals|||Number
1254095|NCT00475709|Primary|Characterize the Hemodynamic Performance of the Valve.|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.~Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.~Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size."|1 year|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.|||mm Hg||Standard Deviation|Mean
1254096|NCT00475709|Primary|Characterize Patient NYHA Functional Classification Status.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|1 year|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.|||percentage of participants|||Number
1254097|NCT00475709|Primary|Late Adverse Event Rates|"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.~Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]"|Events occurring greater than or equal to 31 days post-implant.|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.|||percentage of events/late patient years|||Number
1254098|NCT00475670|Secondary|Overall Survival|The time, in months, from BL to death due to any cause.|BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 52 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||months||95% Confidence Interval|Median
1254099|NCT00475670|Secondary|Overall Survival - Percentage of Participants Who Died|OS was defined as the time from the date of enrollment to the date of death due to any cause. Participants were censored at the last date recorded in the CRF.|BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 5 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants|||Number
1254113|NCT00475644|Secondary|Number of Participants With Response With Expression of Protein Biomarkers|Correlative analyses of tumor RR for PKC-β2 (protein kinase C-β) protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm reported as H scores (logistic model of response rate), which was derived from a weighted average of staining intensity (scale 0 to 3, increasing intensity) and percentage of positive cells (0 to 100%) at each staining intensity. PKC-β2 expression was further classified into high vs. low expression using the cutpoint of the median of the distribution of PKC-β2 H scores.|Baseline|The TR (Translational Research) population consisted of participants from whom tumor tissue was obtained.|||participants|||Number
1255327|NCT00467285|Primary|Changes in BMD 0.33 Radius|% change in BMD at 6 month follow up compared to baseline|6 months||||% change in BMD||Standard Deviation|Mean
1254100|NCT00475670|Secondary|Percentage of Participants With Clinical Benefit According to RECIST Guidelines|Clinical benefit was defined as stable disease (SD) for 6 months or longer, or a confirmed overall response of CR or PR. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the beginning of treatment. For NTLs, SD was synonymous with incomplete response and defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants||95% Confidence Interval|Number
1254101|NCT00475670|Secondary|Time to Treatment Failure|The time, in months, from BL to treatment failure.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||months||95% Confidence Interval|Median
1254102|NCT00475670|Secondary|Percentage of Participants With Treatment Failure|Treatment failure was defined as the time from first study drug infusion to failure. Failure was defined as any of the following: PD, death, withdrawal due to adverse event (AE) or lab abnormality, or refusal of treatment. Participants were censored at the last date recorded in the case report form (CRF) or the date of withdrawal.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants|||Number
1254103|NCT00475670|Secondary|Progression-Free Survival|The time, in months, from BL to PFS event.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||months||95% Confidence Interval|Median
1254104|NCT00475670|Secondary|Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease|PFS was defined as the time from day of first study drug infusion until death or PD. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants|||Number
1254105|NCT00475670|Secondary|Duration of Response|The time, in months, from when the response (CR or PR) was first noted until the date of documented PD, death, or withdrawal, whichever occurred first. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||months||95% Confidence Interval|Median
1254106|NCT00475670|Secondary|Duration of Response - Percentage of Participants With Progressive Disease or Death|Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants|||Number
1254107|NCT00475670|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines|CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.|Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants||95% Confidence Interval|Number
1254108|NCT00475657|Secondary|Stable Disease Rate|Trial terminated - results not analyzed|baseline to measured progressive disease||||participants|||Number
1254109|NCT00475657|Secondary|Duration of Response|Trial terminated - results not analyzed|time of response to progressive disease||||months||Standard Deviation|Mean
1254110|NCT00475657|Secondary|Progression Free Survival|Trial terminated - results not analyzed|baseline to measured progressive disease||||participants|||Number
1254114|NCT00475644|Secondary|Duration of Response (DoR)|DoR is defined as the time from the date when the measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the date of first observation of measured progressive disease. For responding participants who die without progressive disease (including death from study disease), DoR will be censored at the date of death. For responding participants not known to have died as of the data cut-off date and who do not have progressive disease, DoR will be censored at the last objective progression-free assessment date prior to the data cut-off date. For responding participants who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation anticancer therapy.|Time of Response to Measured Progressive Disease (Up to 1415 Days)|Participants who received at least 1 dose of study drug, did not violate any study entry criteria and had baseline and post-baseline response data. There were 4 censored participants.|||Days||95% Confidence Interval|Median
1254115|NCT00475644|Secondary|Time to Response (TtR)|TtR is defined as the time from the date of study enrollment to the date of response (CR, CRu, or PR) for patients who have responded prior to receiving any subsequent anticancer therapy.CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment; CRu, complete disappearance of all detectable clinical and radiographic evidence of disease, return of spleen to non-palpable if involved, residual lymph node mass greater than 1.5 centimeters (cm) has regressed by more than 75%; PR, 50% decrease in the sum of the products of the greatest diameter (SPD) of the 6 largest dominant masses, no increase of other nodes, liver or spleen and no new sites of disease.|Baseline to Date of Confirmed Response (Up to 890 Days)|Participants who received at least 1 dose of study drug and did not violate any study entry criteria and who had baseline and post-baseline response data.|||Days||95% Confidence Interval|Median
1254116|NCT00475644|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from the date of study enrollment to the first date of measured progressive disease or death from any cause. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation anticancer therapy. For reference, PFS will also be calculated and analyzed based on an alternative definition of censoring: for each patient who is not known to have died or to have had objective progression of disease as of the data cut-off date, PFS will be censored for that analysis at the date of last prior contact.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 1559 Days)|Participants who received at least 1 dose of study drug and who did not violate any study entry criteria. There were 18 censored participants.|||Days||95% Confidence Interval|Median
1254117|NCT00475644|Primary|Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])|Tumor response rate is defined as the number of responders divided by the number of treated patients. A responder is a patient who exhibits a complete response (CR), complete response unconfirmed (CRu), or partial response (PR) as defined by Cheson et al. CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment; CRu, complete disappearance of all detectable clinical and radiographic evidence of disease, return of spleen to non-palpable if involved, residual lymph node mass greater than 1.5 centimeters (cm) has regressed by more than 75%; PR, 50% decrease in the sum of the products of the greatest diameter (SPD) of the 6 largest dominant masses, no increase of other nodes, liver or spleen and no new sites of disease.|Baseline to Measured Progressive Disease (up to 1559 Days)|Participants who received at least 1 dose of study drug and did not violate any study criteria.|||percentage of participants||95% Confidence Interval|Number
1254118|NCT00475501|Secondary|Life Satisfaction|Life Satisfaction: is a written test of psychological well-being that will be performed at baseline, after 3, 6, 9 and 12 months of treatment. This is a 20-point scale, with a possible range of scores from 0 to 20. A higher score represents greater life satisfaction.|baseline, 3 months, 6 months, 9 months, 12 months||||points||Standard Error|Mean
1254119|NCT00475501|Secondary|Transrectal Ultrasound Sizing of Prostate|Transrectal ultrasound sizing of prostate will be performed using the B&K Diagnostic System 3535, with 7 mega hertz transrectal probe at baseline and after 6 and 12 months of treatment.|baseline, 6 month, 12 months||||cc||Standard Error|Mean
1254120|NCT00475501|Secondary|Dietary Protein Intake|"Dietary protein intake will be assessed using a 3-day food log and subjects will be counseled to increase protein intake if needed using the guide Healthy Ways to Eat More Protein."|baseline, 3 months, 6 months, 9 months, 12 months||||gm/body weight (kg)||Standard Error|Mean
1254121|NCT00475501|Secondary|Hematocrit|Hematocrit was assessed as a part of routine blood analysis at the indicated time points.|baseline, 3 months, 6 months, 9 months, 12 months||||% volume||Standard Error|Mean
1254122|NCT00475501|Secondary|Benton Judgment of Line Orientation Test|"Benton Judgment of Line Orientation Test is a standardized test with 30 items that is specific for visual spatial cognition. Tests will be administered at baseline, after 3, 6, 9 and 12 months of treatment.~The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition"|baseline, 3 months, 6 months, 9 months, 12 months||||units on a scale||Standard Error|Mean
1254123|NCT00475501|Secondary|Trail-Making Test, Part A|Trail-Making Test, Part A: is a standardized test of cognitive function which specifically assesses working memory, visual processing, visual spatial skills, selective and divided attention, and psychomotor coordination. the test is scored as seconds required to successful completion of the task with a lower score representing better performance. The mean score on test is 30.75 second with a standard deviation of 16.27.|baseline, 3 months, 6 months, 9 months, 12 months||||sec||Standard Error|Mean
1254124|NCT00475501|Secondary|30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test|"Rey Osterrieth Complex Figure (ROCF) test is a widely used standardized neuropsychological test for assessing visuospatial constructional functions, visuographic memory, and some aspects of planning.~The drawing is scored by a blinded neuropsychologist on a scale of 0 to 30 with 30 representing a perfect drawing."|baseline, 3 months, 6 months, 9 months, 12 months||||units on a scale||Standard Error|Mean
1254128|NCT00475501|Primary|1 Repetition Maximum (1-RM) Strength Testing|1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.|baseline, 3 months, 6 months, 9 months, 12 months|per protocol|||kg||Standard Error|Mean
1254129|NCT00475423|Secondary|Change From Baseline in CD19 B Cell Count|Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.|Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day|Safety Analysis Population; n=number of participants assessed for the specified parameter at a given visit.|||10^9 cells/L||Standard Deviation|Mean
1254130|NCT00475423|Secondary|Cluster of Differentiation 19 (CD19) B Cell Count|Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.|Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day|Safety Analysis Population; n (number) = number of participants assessed for the specified parameter at a given visit.|||10^9 cells/L||Standard Deviation|Mean
1254131|NCT00475423|Secondary|Percentage of Participants With a Therapeutic Response|Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.|Week 26 and Week 52|ITTR Population|||percentage participants||95% Confidence Interval|Number
1254132|NCT00475423|Secondary|Percentage of Therapeutic Responders|Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.|Week 26 and Week 52|ITTR Population|||percentage of participants|||Number
1254133|NCT00475423|Secondary|Time to Initiation of New ITP Therapy|Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.|Baseline to Week 52|ITTR Population|||days||95% Confidence Interval|Median
1254134|NCT00475423|Secondary|Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event|Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.|Week 52|ITTR Population|||percentage of participants|||Number
1254135|NCT00475423|Secondary|Duration of MR in Participants With Continued MR From Week 8 Until Week 52|Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population|||days||95% Confidence Interval|Median
1254136|NCT00475423|Secondary|Duration of PR in Participants With Continued PR From Week 8 Until Week 52|Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population|||days||95% Confidence Interval|Median
1254137|NCT00475423|Secondary|Duration of CR in Participants With Continued CR From Week 8 Until Week 52|Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population; only participants with a CR at Week 8 were included in the analysis.|||days||95% Confidence Interval|Median
1254138|NCT00475423|Secondary|Percentage of Participants With Continued CR From Week 8 to Week 52|The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population; only participants with a CR at Week 8 were included in the analysis.|||percentage of participants|||Number
1254139|NCT00475423|Secondary|Time to MR|Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Baseline to Week 52|ITTR Population|||days||95% Confidence Interval|Median
1254140|NCT00475423|Secondary|Percentage of Participants Who Achieved MR|MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population|||percentage of participants|||Number
1287958|NCT00147290|Secondary|Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT||one year|||||||
1254141|NCT00475423|Secondary|Time to PR|Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Baseline to Week 52|ITTR Population|||days||95% Confidence Interval|Median
1254142|NCT00475423|Secondary|Percentage of Participants Who Achieved PR|PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population|||percentage of participants|||Number
1254143|NCT00475423|Secondary|Time to CR|Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.|Baseline to Week 52|ITTR Population|||days||95% Confidence Interval|Median
1254144|NCT00475423|Secondary|Percentage of Participants Who Achieved CR|CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population|||percentage of participants|||Number
1254145|NCT00475423|Secondary|Percentage of Participants With Hematological CR, PR, or Minor Response (MR)|Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.|Week 8|ITTR Population|||percentage of participants||95% Confidence Interval|Number
1254146|NCT00475423|Primary|Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)|Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.|Week 8|Intent-to-Treat Replaced (ITTR) Population: participants who received at least 1 dose of study medication, excluded those lost to follow-up before completing treatment (reasons other than disease progression/toxicity) and/or those without documented platelet count of less than or equal to (≤)50x10^9/L within 7 days prior to 1st rituximab infusion.|||percentage of participants||95% Confidence Interval|Number
1254147|NCT00475332|Secondary|The Secondary Endpoint Will be to Assess Response Rates and Patterns of Failure in Patients Treated With Bexxar and External Beam Radiotherapy (EBRT).|Tumor response to treatment is measured using the RECIST criteria: Response Evaluation Criteria in Solid Tumors which defines Complete Response, Partial Response, Progressive Disease, and Stable Disease, by using tumor measurements as seen on CT or MRI|2 yr 3 mos|Two patients were enrolled and the study was terminated. No analyses were conducted.|||Participants|||Number
1254148|NCT00475332|Primary|The Primary Endpoint of the Study Will be to Determine the Feasibility of Combining External Beam Radiotherapy (EBRT) and Bexxar by Assessing the Toxicities Associated With the Treatment.|13 patients will be enrolled initially and followed for 3 months. If less than 10 of these patients reach a grade III or IV toxicity, then 12 more patients will be enrolled and the study will be deemed feasible. If 11 or more of the first group experience grade III/IV toxicity, the trial will stop early.|2 yr 3 mos|Two patients were enrolled and the study was terminated. No analyses were conducted.|||Participants|||Number
1254149|NCT00475319|Secondary|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared.|Baseline, 4weeks||||LGCS score||Standard Deviation|Mean
1254150|NCT00475319|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-15). 0 is better.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|Baseline, 4weeks||||FCS score||Standard Deviation|Mean
1254151|NCT00475306|Secondary|Number of Participants With Akathisia|The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness.|60 minutes|Only patients who received the investigational medication are included in this analysis. Please see participant flow for details|||participants|||Number
1254152|NCT00475306|Primary|Nausea Scale|Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable|60 minutes|Only patients who received the investigational medication are included in this analysis. Please see the participant flow section for more details.|||units on a scale||Inter-Quartile Range|Median
1254153|NCT00475241|Secondary|All of Below Measures Are Taken at the Major Assessment Points.- Beck Depression Inventory-II- Depression Anxiety Stress Scale- Posttraumatic Cognitions Inventory- Client Satisfaction Questionnaire||pre, mid, post, 3 and 6 mo FU|||||||
1254155|NCT00475241|Secondary|Psychophysiological Reactivity Will be Assessed Using a Biopac MP-100 Physiology Recording System for Measurement of Heart Rate (Electrocardiography, ECG), Skin Conductance, Respiration, and End-tidal pCO2 (Pre, Mid, Posttreatment, 3 and 6 mo FU).||pre, mid, post, 3 and 6 mo FU|||||||
1254156|NCT00475241|Primary|Clinician Administered PTSD Scale (Pre & Posttreatment)|Clinician Adminstered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.|PostTreatment (Week 12)|Treatment Completers|||units on a scale||Standard Deviation|Mean
1254157|NCT00475228|Secondary|To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion|Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group|6 months|3 of the 44 participants who had the LNG-IUD placed in Arm 1 underwent an IUD expulsion. 1 of the 20 participants who had the LNG-IUD placed in Arm 2 underwent an IUD expulsion.|||percentage of participants|||Number
1254158|NCT00475228|Secondary|To Examine the Number of Women Receiving the LNG-IUD in Each Group|The difference between the overall number of women who had the LNG-IUD inserted immediately post D&E successfully (Arm 1) was compared to the overall number of women who had the LNG-IUD inserted 3 -6 weeks post D&E (standard or routine) (Arm 2).|2 Months|In Arm 1, all 44 participants were inserted with an LNG-IUD immediately post D& E successfully. In Arm 2; only 20 of the 44 participants returned and had the LNG-IUD inserted successfully 3 to 6 weeks post D&E.|||Completed LNG-IUD Insertions|Completed LNG-IUD Insertions||Number
1254159|NCT00475228|Primary|The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.|"To assess the six-month usage rate of the LNG-IUD when placed immediately after D&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D&E.~We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than women receiving delayed insertion."|6 months|Attempts to contact all participants (Arm 1: 44 women and Arm 2: 44 women) by phone 6 months post D&E were made. For Arm 1, 27 out of 44 women could be reached. For Arm 2; 27 out of the 44 were reached (19 women who returned and had the LNG-IUD placed 3-6 weeks post D&E and 8 women who did not return for the LNG-IUD placement 3-6 post D&E).|||percentage of participants||95% Confidence Interval|Number
1254160|NCT00475176|Secondary|2-log Decline in HCV RNA by Week 12 (Early Virological Response) and Sustained Eradication of HCV RNA (Sustained Virological Response).|2-log decline in HCV RNA by week 12 (early virological response) and sustained eradication of HCV RNA (sustained virological response).|12 weeks from start of therapy|Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.|||participants|||Number
1254161|NCT00475176|Primary|Improvement in Viral Kinetics During the First 2 Weeks of Therapy|Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy|Days 7 to 14 of therapy|Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.|||participants|||Number
1254162|NCT00475150|Secondary|The Number of Patients That Report Adverse Events Possibly, Probably, or Definitely Related to AZD2171.|Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All adverse events determined to be possibly, probably, or definately related to AZD2171 are included in this analysis.|Continuously during treatment up to 26 courses|All participants were analyzed for this endpoint.|||participants|||Number
1254163|NCT00475150|Secondary|Duration of Response|Measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Estimated using the method of Kaplan-Meier.|Every 3 courses up to 26 courses|This endpoint was not analyzed due to lack of response.||||||
1254164|NCT00475150|Secondary|Progression-free Survival|"Defined as the time from date of registration to date that disease progression was documented, death, or last date that progression-free status was documented, whichever comes first. Estimated using the method of Kaplan-Meier.~Disease progression is defined as one of the following:~A ≥ 50% increase in bone marrow blasts from the best response, or~A 50% or greater decrement from maximum remission/response levels in neutrophils or platelets, or~A reduction in hemoglobin concentration by at least 1.5 g/dl, or~Transfusion dependence (without alternative explanation and sustained for at least 2 weeks)."|Every 3 courses during treatment and then at 3 months and every 6 months for up to 2 years after completion of study treatment|All participants are evaluable for this primary endpoint.|||months||95% Confidence Interval|Median
1254165|NCT00475150|Secondary|Overall Survival|Defined as the time from date of registration to date of death due to any cause or date last known alive. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Every cycle during treatment and every 6 months for up to 2 years after completion of study treatment|All participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
1254166|NCT00475150|Primary|The Number of Confirmed Disease Response: Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI). A Confirmed Response is Defined to be an Objective Status of CR, PR, or HI Noted on 2 Consecutive Evaluations.|"Complete Response (CR) requires a repeat bone marrow with < 5% myeloblasts, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.~Partial Response (PR) requires a bone marrow blast reduction of 50% or more, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.~Hematologic Improvement (HI) requires one of the following:~RBC transfusion independent participants are required to have >1.5 g/dL increase in hemoglobin,~RBC transfusion-dependent participants are required to be transfusion independent,~A 100% increase, and an absolute increase over 500mm^3 in Absolute Neutrophil Count,~Participants with a pretreatment platelet count over 20,000/mm3 require an absolute increase of 30,000/mm^3 or more,~Participants with platelet count below 20,000/mm3 require an increase over 20,000/mm^3 and by at least 100%."|At the end of cycles 1 and 3 and every 3 cycles thereafter up to 26 cycles|All participants were evaluable for this endpoint.|||participants|||Number
1254167|NCT00475085|Primary|Home Record: Severity of Delayed Nausea|1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse|average of day 1 afternoon, evening and night, and all of days 2 and 3||||units on a scale||Standard Deviation|Mean
1254168|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (12 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
1254169|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (6 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
1254170|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (4 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
1254171|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (2 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
1254172|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (12 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
1254173|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (6 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
1254174|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (4 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
1254175|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (2 months of age)|Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
1254176|NCT00475033|Secondary|Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration (titer) to the given antigen.|||percentage of subjects||95% Confidence Interval|Number
1254185|NCT00475033|Secondary|Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®|Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the toddler dose of NeisVac-C® (13 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-toddler dose antibody concentration (titer) to the given antigen.|||percentage of subjects||95% Confidence Interval|Number
1254177|NCT00475033|Primary|Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|||GMC µg/mL||95% Confidence Interval|Geometric Mean
1254178|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.|||percentage of subjects||95% Confidence Interval|Number
1254179|NCT00475033|Primary|Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the 3-dose Infant Series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|||GMC EU/mL||95% Confidence Interval|Geometric Mean
1254180|NCT00475033|Other Pre-specified|Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.|||GMC μg/mL||95% Confidence Interval|Geometric Mean
1254181|NCT00475033|Other Pre-specified|Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.|||percentage of subjects||95% Confidence Interval|Number
1254182|NCT00475033|Other Pre-specified|Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.|||GMC μg/mL||95% Confidence Interval|Geometric Mean
1254183|NCT00475033|Other Pre-specified|Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.|||percentage of subjects||95% Confidence Interval|Number
1254184|NCT00475033|Secondary|Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|||GMT||95% Confidence Interval|Geometric Mean
1255328|NCT00467285|Primary|Changes in BMD AP Spine|% change in BMD at 6 month follow up compared to baseline|6 months||||% change in BMD||Standard Deviation|Mean
1254186|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with an antibody concentration (titer) ≥ to prespecified level for the given antigen for 13vPnC and 7vPnC, respectively.|||percentage of subjects||95% Confidence Interval|Number
1254187|NCT00475033|Primary|Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series|Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|||GMT||95% Confidence Interval|Geometric Mean
1254188|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series|Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.|||percentage of subjects||95% Confidence Interval|Number
1254189|NCT00475020|Secondary|Efficacy of This Therapy 3 Years Post-transplant|Focusing on overall survival, leukemia progression, primary graft failure and complete hematologic response 3 years post-transplant|Monitor until one of these off study criteria has met or at 3 years post-transplant: Disease progression, death, primary graft failure or lost to follow up||||Participants|||Count of Participants
1254190|NCT00475020|Primary|Rate of Non-relapse Mortality at 100 Days Post-transplant|To evaluate the safety of Fludarabine/Busulfan as conditioned regimen for allogeneic stem cell transplantation in patients with myelofibrosis/myelodysplastic syndrome at 100 days post-transplant|Non-relapse mortality at 100 days post-transplant||||Participants|||Count of Participants
1254191|NCT00474994|Primary|Overall Objective Response|as assessed by RECIST criteria|2 years||||participants|||Number
1254192|NCT00474968|Primary|Specimen Adequacy|Number and percentage of samples classified as adequate for diagnosis|At time of cell collection|Includes all cytology specimens|||Participants|||Number
1254193|NCT00474968|Secondary|Human Papilloma Virus (HPV) Detection Frequency|Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay|At the time of cell collection.||||Participants|||Number
1254194|NCT00474968|Primary|Cell Collection Efficacy|True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.|At the time of cell collection.|79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported|||Participants|||Number
1254195|NCT00474955|Secondary|Mean Change From Baseline in Heart Rate up to Week 72|Mean change from baseline in heart rate was recorded at Baseline (Screening visit [Days -30 to -1]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|From Baseline (Days -30 to -1) to Week 72|ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by ‘n’.|||Beats per minute (bpm)||Standard Deviation|Mean
1254196|NCT00474955|Secondary|Mean Change From Baseline in Blood Pressure up to Week 72|Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|From Baseline (Days -30 to -1) to Week 72|ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by ‘n’.|||Millimeter (mm) of Mercury||Standard Deviation|Mean
1254197|NCT00474955|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks|Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|Up to Week 72|ITT population included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1255329|NCT00467285|Secondary|Changes in CTx at Follow up|% change in the levels of CTx at 6 months follow up compared to baseline|6 months||||% change||Standard Deviation|Mean
1254198|NCT00474955|Secondary|Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks|Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented.|Up to Week 48|ITT population included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1254199|NCT00474955|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect|Up to Week 72|Safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.|||Participants|||Number
1254200|NCT00474955|Primary|Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline|The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]).|From Baseline (Days -30 to -1) and Week 24|ITT population included all enrolled participants who received at least one dose of study medication.|||Percentage of participants|||Number
1254201|NCT00474955|Primary|Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48|HCV RNA level less than 50 IU/mL was considered to be undetectable.|At Week 24 and Week 48|ITT population included all enrolled participants who received at least one dose of study medication.|||Percentage of participants|||Number
1254202|NCT00474955|Primary|Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion|Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).|At Week 72|ITT population included all enrolled participants who received at least one dose of study medication.|||Percentage of participants|||Number
1254203|NCT00474929|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from registration to the earliest date documentation of disease progression or death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
1254204|NCT00474929|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
1254205|NCT00474929|Primary|Proportion of Confirmed Tumor Responses|"A confirmed response is defined to be a CR or PR noted as the objective status for eligible patients during cycles 1-12.~Complete Response (CR):~Multiple Myeloma (MM): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and normalization of free light chain (FLC) ratio.~Lymphoma: Disappearance of all clinical and radiographic evidence of disease, all lymph nodes of normal size (1.5 cm or less), no splenomegaly.~Partial Response (PR):~MM: 50% reduction of serum or urine M-protein or to less than 200mg/day, a 50% reduction in the difference between involved and uninvolved FLC, and 50% reduction in the size of soft tissue plasmacytoma.~Lymphoma: 50% or greater reduction in sum of the products of the dimension for nodal masses; no increase in liver, spleen or node size; no new sites of disease; and a 50% decrease in lymphocyte count if followed at baseline."|Up to 12 cycles of treatment||||percentage of participants|||Number
1254206|NCT00474929|Primary|Number of Participants Reporting a Dose Limiting Toxicity (DLT)|"The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). Dose-limiting toxicity (DLT) is defined as an adverse event attributed (definitely, probably, or possibly) in first cycle to the study treatment and meeting the following criteria:~Grade 4 infection~Grade 4 ANC or PLT~Grade 3 or higher non-hematologic adverse event.~NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 will be used to assess adverse events. For this endpoint, the number of patients reporting a DLT event are tabulated."|First cycle (28 days) of study treatment||||participants|||Number
1254207|NCT00474903|Secondary|Toxicity|Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the interventional agent, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of patients reporting adverse events will be tabulated by grade.|Up to 30 days after completion of study treatment|All 120 patients that took study medication were evaluable for this secondary endpoint.|||participants|||Number
1254208|NCT00474903|Primary|Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples|The mean tissue PGE2 is reported for each Arm.|Baseline to 30 days after completion of study treatment||||pg/mL||Standard Deviation|Mean
1254209|NCT00474851|Secondary|Total Body Bone Mineral Content (BMC)||Baseline to 12 months||||g||Standard Error|Mean
1254210|NCT00474851|Primary|Bone Mineral Density|Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial|Baseline to 12 months||||g/cm^2||Standard Error|Mean
1254211|NCT00474812|Secondary|Gait Speed|Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.|at 8 weeks|Participants who were ambulatory at 8 weeks|||meters per second||Standard Error|Mean
1254212|NCT00474812|Secondary|Gait Speed|Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.|baseline|Participants who were ambulatory at baseline|||meters per second||Standard Error|Mean
1254213|NCT00474812|Secondary|Median Progression Free Survival (PFS)|Number of months patients were free of disease progression, defined as < 20% increase in the sum of the LD of target lesions nor the appearance of one or more new lesions.|Up to 5 years|Intent to treat|||months||95% Confidence Interval|Median
1287959|NCT00147290|Secondary|Compare Efficacy of the First BiV and RV ATP to Terminate FVT||one year|||||||
1254214|NCT00474812|Secondary|Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee|Response is defined as CR (Complete Response), PR (Partial Response) or SD (Stable Disease) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD). Progressive disease (PD) is defined as: at least a 20% increase in the sum of the LD of target lesions.|Up to 5 years|Patients that reached first scans at 2 months|||participants|||Number
1254215|NCT00474812|Primary|Median Overall Survival|From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months|assessed up to 24 months|Intent to treat.|||months||95% Confidence Interval|Median
1254216|NCT00474786|Other Pre-specified|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 24 months|Safety population: all participants who received at least 1 dose of test article.|||participants|||Number
1254217|NCT00474786|Secondary|Duration of Response (DR)|Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.|Baseline up to 24 Months|ITT population|||months||95% Confidence Interval|Median
1254218|NCT00474786|Secondary|Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment|PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.|Weeks 12, 24, and 36|ITT population|||percentage of participants|||Number
1254219|NCT00474786|Secondary|Overall Survival (OS)|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline to date of death from any cause (up to 24 months)|ITT population|||months||95% Confidence Interval|Median
1254220|NCT00474786|Secondary|Percentage of Participants With Tumor Response|Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Baseline up to 24 Months|ITT population|||percentage of participants||95% Confidence Interval|Number
1254221|NCT00474786|Secondary|Progression Free Survival (PFS) by Investigator Assessment|Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.|Baseline up to 24 Months|ITT population|||months||95% Confidence Interval|Median
1254222|NCT00474786|Primary|Progression-Free Survival (PFS)|Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.|Baseline up to 24 Months|Intent to Treat Population (ITT): all randomized participants according to their assigned treatment, regardless of whether they were received any study drug.|||months||95% Confidence Interval|Median
1254223|NCT00474760|Secondary|Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs|Quantification of IGF-IR positive CTCs using an automated microscope system|30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort|Pretreatment IGF-1R positive CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.||||||
1254224|NCT00474760|Secondary|Number of Circulating Tumor Cells (CTCs)|Quantification of CTCs using an automated microscope system|30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort|Pretreatment CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.||||||
1254225|NCT00474760|Secondary|Human Anti-human Antibodies (HAHA) Levels|HAHA were indicators of immunogenicity to figitumumab.|30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)|Per protocol, the presence of HAHA would only be evaluated for those samples with plasma figitumumab concentrations below the limit of quantification (BLQ). Since none of the postdose samples in the study had figitumumab concentrations BLQ, therefore no sample was analyzed for HAHA.||||||
1254226|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure|||mg*hr/L||Standard Deviation|Mean
1254227|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure|||mg*hr/L||Standard Deviation|Mean
1254228|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.|||mg*hr/L||Standard Deviation|Mean
1255330|NCT00467285|Primary|Changes in BMD Total Hip|% change at 6 month follow up compared to baseline|6 months||||% change in BMD||Standard Deviation|Mean
1255331|NCT00467285|Secondary|Osteocalcin|% change at 6 month follow up compared to baseline|6 months||||% change||Standard Deviation|Mean
1254229|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.|||mg*hr/L||Standard Deviation|Mean
1254230|NCT00474760|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1|Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg*hr/L||Standard Deviation|Mean
1254231|NCT00474760|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg*hr/L||Standard Deviation|Mean
1254232|NCT00474760|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||milligram*hour/liter (mg*hr/L)||Standard Deviation|Mean
1254233|NCT00474760|Secondary|Volume of Distribution at Steady State (Vss) in Cycle 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mL/kg||Standard Deviation|Mean
1254234|NCT00474760|Secondary|Volume of Distribution at Steady State (Vss) in Cycle 1|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mL/kg||Standard Deviation|Mean
1254235|NCT00474760|Secondary|Volume of Distribution (Vz) in Cycle 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mL/kg||Standard Deviation|Mean
1254236|NCT00474760|Secondary|Volume of Distribution (Vz) in Cycle 1|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||milliliter/kilogram (mL/kg)||Standard Deviation|Mean
1254237|NCT00474760|Secondary|Concentration at End of Infusion (Cendinf) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg/L||Standard Deviation|Mean
1254238|NCT00474760|Secondary|Concentration at End of Infusion (Cendinf) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg/L||Standard Deviation|Mean
1254239|NCT00474760|Secondary|Systemic Clearance (CL) in Cycle 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mL/day/kg||Standard Deviation|Mean
1254240|NCT00474760|Secondary|Systemic Clearance (CL) in Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||milliliter/day/kilogram (mL/day/kg)||Standard Deviation|Mean
1254241|NCT00474760|Secondary|Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
1254242|NCT00474760|Secondary|Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
1254243|NCT00474760|Secondary|Plasma Decay Half-Life (t1/2) in Cycle 4|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
1254244|NCT00474760|Secondary|Plasma Decay Half-Life (t1/2) in Cycle 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
1254245|NCT00474760|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
1254246|NCT00474760|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
1254247|NCT00474760|Secondary|Maximum Observed Plasma Concentration (Cmax) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg/L||Standard Deviation|Mean
1254248|NCT00474760|Secondary|Maximum Observed Plasma Concentration (Cmax) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||milligram/liter (mg/L)||Standard Deviation|Mean
1254249|NCT00474760|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 150 days after the last administration of study drug|All enrolled participants who started treatment.|||participants|||Number
1254250|NCT00474708|Secondary|Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.|12 weeks|The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment. A total of 125 (VEN XR=83, SSRI=42) patients had a co-morbid anxiety disorder and 834 (VEN XR=581, SSRI=253) did not.|||participants|||Number
1254251|NCT00474708|Primary|Number of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.|12 weeks|The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment.|||participants|||Number
1254266|NCT00474630|Secondary|Percent of Subjects With Dose Reduction in Oral Antidiabetes Medications||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1254267|NCT00474630|Secondary|Percent of Subjects Requiring Rescue Medications for Diabetes||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1254252|NCT00474630|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1254253|NCT00474630|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1254254|NCT00474630|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1254255|NCT00474630|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
1254256|NCT00474630|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
1254257|NCT00474630|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1254258|NCT00474630|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1254259|NCT00474630|Secondary|Percent of Subjects Discontinuing Due to Poor Glycemic Control|Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed. Odds ratio not calculated as there were no subjects in the NB32 group that discontinued due to poor glycemic control.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1254260|NCT00474630|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1254261|NCT00474630|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1254262|NCT00474630|Secondary|HbA1c- Proportion of Subjects With HbA1c <6.5% at Endpoint||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1254263|NCT00474630|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1254264|NCT00474630|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1254265|NCT00474630|Secondary|Percent of Subjects With Dose Increase in Oral Antidiabetes Medications||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1255332|NCT00467285|Secondary|CTx|% Change in bone turnover markers at 6 month follow up compared to baseline|6 months||||pg/mL||Standard Deviation|Mean
1254268|NCT00474630|Secondary|HbA1c- Proportion of Subjects With HbA1c <7% at Endpoint||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1254269|NCT00474630|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1254270|NCT00474630|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||cm||Standard Error|Least Squares Mean
1254271|NCT00474630|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1254272|NCT00474630|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1254273|NCT00474630|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1254274|NCT00474630|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1254275|NCT00474630|Secondary|Change in HbA1c Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent||Standard Error|Least Squares Mean
1254276|NCT00474630|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
1254277|NCT00474539|Secondary|Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.|One month after toddler dose (at 16 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate IgG antibody concentration to the given concomitant vaccine component.|||percentage of participants||95% Confidence Interval|Number
1254278|NCT00474539|Primary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1254279|NCT00474539|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1254280|NCT00474539|Primary|Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose||One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
1254281|NCT00474539|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose|Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).|One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1254282|NCT00474539|Primary|Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose||One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)|The evaluable 2-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1254283|NCT00474539|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1254284|NCT00474539|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1254285|NCT00474539|Primary|Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series|Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.|One month after infant series dose (at 5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.|||percentage of participants||95% Confidence Interval|Number
1254286|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.|12 or 15 months of age (one month post 1st or 2nd toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1254287|NCT00474526|Secondary|Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 or 15 months of age (one month post 1st or 2nd toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254288|NCT00474526|Secondary|Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens|17 months of age (one month post-toddler vaccination)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
1254289|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens|17 months of age (one month post-toddler vaccination)|Per Protocol|||Titers||95% Confidence Interval|Geometric Mean
1254290|NCT00474526|Secondary|Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F|13 months of age (one month post-toddler vaccination)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
1254291|NCT00474526|Secondary|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination – LA Subjects|Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol|||Concentrations (μg/mL)||95% Confidence Interval|Geometric Mean
1254292|NCT00474526|Secondary|Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects|Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
1254293|NCT00474526|Secondary|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects|Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol|||Titers||95% Confidence Interval|Geometric Mean
1254294|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1254295|NCT00474526|Secondary|Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1288226|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48||Month 48||||L||Standard Error|Mean
1254296|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254297|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254298|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1254299|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254300|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254301|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254302|NCT00474526|Secondary|Persistence Antibodies Geometric Mean Titers - LA Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1254303|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254304|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254305|NCT00474526|Secondary|Persistence Antibodies Geometric Mean Titers – US Subject|Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.|12 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1254306|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 Months of Age (one month pre-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"|||Percentages of subjects||95% Confidence Interval|Number
1254307|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.|12 Months of Age (one month pre-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"|||Percentages of subjects||95% Confidence Interval|Number
1254308|NCT00474526|Secondary|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
1254309|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol|||Titers||95% Confidence Interval|Geometric Mean
1254310|NCT00474526|Secondary|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
1269976|NCT00360334|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to endpoint|26 Weeks|Full Analysis Set|||cm||Standard Error|Least Squares Mean
1254311|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol|||Titers||95% Confidence Interval|Geometric Mean
1254312|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .|7 months of age (one month post-infant series)|Per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254313|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .|7 months of age (one month post-infant series)|Per protocol population|||Percentages of subjects||95% Confidence Interval|Number
1254314|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:4 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|Per Protocol Population|||Percentages of subjects||95% Confidence Interval|Number
1254315|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|Per Protocol Population|||Percentages of subjects||95% Confidence Interval|Number
1254316|NCT00474526|Secondary|Geometric Mean hSBA Titers Post-infant Series - LA Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.|7 months of age (one month post-infant series)|Per protocol population|||Titer||95% Confidence Interval|Geometric Mean
1254317|NCT00474526|Secondary|Geometric Mean hSBA Titers Post-infant Series - US Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1254318|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination – Infant Series|Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the third dose in the infant series were included in this analysis.|||Subjects|||Number
1254319|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Infant Series|Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose of the infant series vaccination were included in the analysis.|||Subjects|||Number
1254320|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Infant Series|Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.|||Subjects|||Number
1254321|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Toddler Series|Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.|7 days post vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose at 15 months were included in this analysis.|||Subjects|||Number
1254322|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Toddler Series|Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days post vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.|||Subjects|||Number
1254323|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age|Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.|||Subjects|||Number
1254324|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination – Infant Series|Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.|||Subjects|||Number
1254325|NCT00474526|Primary|Geometric Mean hSBA Titers – US Subjects|Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1254794|NCT00470847|Primary|The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer.|The maximum tolerated dose is defined as :The highest dose of a drug or treatment that does not cause unacceptable side effects.|5 Years||||milligrams|||Number
1254326|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Infant Series|Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. LA1 and LA 2 groups are not included here as they did not receive MenACWY at 4 months of age.|||Subjects|||Number
1254327|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Infant Series|Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set Safety population was defined as: all subjects in the exposed population who provided post-baseline safety data. If a subject received an entirely wrong vaccine schedule (e.g., US3 instead of US4), the subject would be analyzed for safety according to the group the subject actually followed.|||Subjects|||Number
1254328|NCT00474526|Primary|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age|13 months of age (one month post-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"|||Percentages of subjects||95% Confidence Interval|Number
1254329|NCT00474487|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years|Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).|Days 1 to 7|The analysis was done on the safety population.|||Subjects|||Number
1254330|NCT00474487|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years|Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).|Days 1 to 7|The analysis was performed on the safety population.|||Subjects|||Number
1254331|NCT00474487|Secondary|Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population|Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1254332|NCT00474487|Secondary|Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population|Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1254333|NCT00474487|Secondary|Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population|"Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years).~Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
1254334|NCT00474487|Secondary|Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population|"Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years).~Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
1254335|NCT00474487|Primary|Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years|Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.|Days 1 to 7|The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.|||Subjects|||Number
1254336|NCT00474383|Secondary|Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)|The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study.|||participants|||Number
1254337|NCT00474383|Secondary|Overall Survival|Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.|Baseline until death, or end of study (Week 148)|The ITT population included all the participants who were enrolled into the study.|||days||95% Confidence Interval|Median
1254338|NCT00474383|Secondary|Progression Free Survival Time|Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.|||days||95% Confidence Interval|Median
1254339|NCT00474383|Secondary|Duration of PSA Response|Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)|The ITT population included all the participants who were enrolled into the study.|||days||95% Confidence Interval|Median
1254340|NCT00474383|Secondary|Time to PSA Progression|The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)|The ITT population included all the participants who were enrolled into the study.|||days||95% Confidence Interval|Median
1254341|NCT00474383|Secondary|Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)|The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.|Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.|||percentage of participants||95% Confidence Interval|Number
1254342|NCT00474383|Secondary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.|Baseline up to Week 12|The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
1254343|NCT00474383|Primary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.|Baseline, Week 12|The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
1254344|NCT00474266|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.|From Day 0 up to Month 6 after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
1254345|NCT00474266|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 43-day (Days 0-42) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
1254346|NCT00474266|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 43-day (Days 0-42) post Dose 1 vaccination period|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
1254347|NCT00474266|Secondary|Number of Subjects Reporting Specific Adverse Events (AEs)|Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.|From Day 0 up to Month 6 after first vaccine dose|The analysis was performed on the Total Vaccinated Cohort (TVC ), which included all vaccinated subjects.|||Participants|||Count of Participants
1254348|NCT00474266|Secondary|Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms|Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.|During the 43-day (Days 0-42) after first vaccination dose|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
1254349|NCT00474266|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.|During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
1256687|NCT00457977|Primary|Serotype Opsonization Titers|Opsonophagocytosis activity (OPK) serotype specific geometric means|Measured at Baseline, Months 1, 12, and 24|All participants with blood samples were analyzed.|||titers||95% Confidence Interval|Geometric Mean
1254350|NCT00474266|Secondary|Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0|Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.|During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
1254351|NCT00474266|Secondary|Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination|Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.|During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
1254352|NCT00474266|Secondary|Anti-varicella Antibody Titers|Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.|42 days after the second Priorix-Tetra vaccine dose (Day 126)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1254353|NCT00474266|Secondary|Anti-varicella Antibody Titers|Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1254354|NCT00474266|Secondary|Anti-rubella Antibody Concentrations|Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.|42 days after the second Priorix-Tetra vaccine dose (Day 126)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1254355|NCT00474266|Secondary|Anti-rubella Antibody Concentrations|Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1254356|NCT00474266|Secondary|Anti-mumps Antibody Concentrations|Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.|42 days after the second Priorix-Tetra vaccine dose (Day 126)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||U/mL||95% Confidence Interval|Geometric Mean
1254357|NCT00474266|Secondary|Anti-mumps Antibody Concentrations|Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||U/mL||95% Confidence Interval|Geometric Mean
1254358|NCT00474266|Secondary|Anti-measles Antibody Concentrations|Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.|42 days after the second Priorix-Tetra vaccine dose (Day 126)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1254359|NCT00474266|Secondary|Anti-measles Antibody Concentrations|Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1254369|NCT00474266|Primary|Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values|The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1254360|NCT00474266|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.|Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1254361|NCT00474266|Secondary|Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values|The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.|Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1254362|NCT00474266|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values|The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.|Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1254363|NCT00474266|Secondary|Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values|Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.|Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1254364|NCT00474266|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.|Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1254365|NCT00474266|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values|The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.|Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1254366|NCT00474266|Primary|Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values|The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1254367|NCT00474266|Primary|Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.|The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1254368|NCT00474266|Primary|Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values|The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1254370|NCT00474266|Primary|Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values|The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1254371|NCT00474240|Secondary|Percent Change From Baseline of Other Lipids||After 8 weeks of study drug|Intent To Treat|||Percent||Standard Deviation|Mean
1254372|NCT00474240|Primary|Percent Change From Baseline in LDL-C at 8 Weeks||Atfer 8 weeks on study drug|Intent To Treat|||Percent Change||Standard Deviation|Mean
1254373|NCT00474201|Primary|Gemfibrozil Area Under the Concentration vs. Time Curve (AUC)|AUC (ng*hr/mL) of gemfibrozil when given as a 600 mg dose by itself compared to gemfibrozil AUC after 14.5 days of lopinavir-ritonavir (400mg/100mg) twice daily.|22 days per subject (approximately 1 year for entire study completion)|Fifteen healthy volunteers were enrolled in this protocol based on an a priori power analysis. All 15 subjects completed the protocol and results reported are those from all 15 participants.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
1254374|NCT00474188|Secondary|Progression-free Survival|"Time from the start of study drug therapy to the first observation of disease progression or death due to any cause.~Study terminated prematurely. Analysis not conducted."|One year||||Days||95% Confidence Interval|Median
1254375|NCT00474188|Secondary|Time to Progression|"Time from the start of study drug therapy to the first documentation of disease progression.~Study terminated prematurely. Analysis not conducted."|One year||||Days||95% Confidence Interval|Median
1254376|NCT00474188|Secondary|Duration of Response|"Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma.~Study terminated prematurely. Analysis not conducted."|One year||||Days||95% Confidence Interval|Median
1254377|NCT00474188|Secondary|Tumor Control Rate|"Number of participants demonstrating complete tumor response, partial tumor response, or stable disease.~Study terminated prematurely. Analysis not conducted."|One Year||||Participants||95% Confidence Interval|Mean
1254378|NCT00474188|Primary|Tumor Response Rate|"Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53).~Study terminated prematurely. Analysis not conducted."|One Year|Study terminated prematurely. Analyses of efficacy not conducted.|||Participants||95% Confidence Interval|Mean
1254379|NCT00474175|Other Pre-specified|Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication||Baseline and 5 minutes|Safety population included all participants who received at least 1 dose of study medication and had follow up data.|||Percentage of participants||95% Confidence Interval|Number
1254380|NCT00474175|Other Pre-specified|Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied|Amount of study medication applied was calculated by weighing medication tube prior and post-dosing.|Baseline and 5 minutes|Safety population included all participants who received at least 1 dose of study medication and had follow up data.|||Milligram (mg)||Standard Deviation|Mean
1254381|NCT00474175|Secondary|Global Satisfaction Assessment|Participants were asked to provide an overall assessment of their satisfaction with the study medication on a categorical scale. Response in this scale was assigned values as 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent).|120 minutes|ITT population included all randomized participants who received study medication.|||Units on a scale||Standard Deviation|Mean
1254382|NCT00474175|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores|PRID is sum of PID and DPRS scores at each post-dosing time point. The overall possible score range, for PRID is -1 (worst) to 7 (best). PID was calculated as baseline DPS minus DPS score at given time point (DPS range from 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).|5 to 120 minutes|ITT population included all randomized participants who received study medication.|||Units on a scale||Standard Deviation|Mean
1254383|NCT00474175|Secondary|Time to Dropping Out Due to Lack of Efficacy or Rescue Medication|Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication (ibuprofen 200-400 mg or acetaminophen 1000 mg), whichever comes first.|0 to 120 minutes|ITT population included all randomized participants who received study medication.|||Minutes||95% Confidence Interval|Median
1254384|NCT00474175|Secondary|Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores|SPRID is time-weighted sum of pain relief scores combined with pain intensity difference (PRID) scores over 60 and 120 minutes. SPRID score range was 0 (worst) to 7 (best) for SPRID 60 and 0 (worst) to 14 (best) for SPRID 120. PRID is sum of Pain intensity differences (PID) and Dental pain relief scale (DPRS) scores at each post-dosing time point. PID was calculated as baseline DPS minus DPS score at given time point (DPS range: 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).|60 minutes and 120 minutes|ITT population included all randomized participants who received study medication.|||Units on a scale||Standard Deviation|Mean
1254385|NCT00474175|Secondary|Duration of Effect|Duration of effect was defined as the time difference between onset of effect and its offset. Onset of effect was the first time point at which two consecutive pain scores less severe than at baseline by at least 1 unit (on the DPS) were attained. Offset of effect was the first of the following events to occur after onset: time to drop out if the drop out was due to lack of efficacy, time of rescue medication, or the first time point following onset of effect at which two consecutive pain scores that are at least as severe as at baseline were attained.|0 to 120 minutes|ITT population included all randomized participants who received study medication.|||Minutes||95% Confidence Interval|Median
1254403|NCT00474045|Secondary|Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||ratio||Full Range|Median
1254386|NCT00474175|Secondary|Time to Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.|0 to 120 minutes|ITT population included all randomized participants who received study medication.|||Minutes||95% Confidence Interval|Median
1254387|NCT00474175|Secondary|Time to First Confirmed Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.|0 to 120 minutes|ITT population included all randomized participants who received study medication.|||Minutes||95% Confidence Interval|Median
1254388|NCT00474175|Primary|Percentage of Participants With a Response|Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points. Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe).|Baseline, 5, 10, 15 and 20 minutes|Intent to treat (ITT) population included all randomized participants who received study medication.|||Percentage of participants|||Number
1254389|NCT00474123|Secondary|Endothelial Progenitor Cells|Endothelial progenitor cells were evaluated by flow cytometry. Selected cells were positive for CD31, CD34 and VEGFR receptors.|Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.||||percentage||Standard Deviation|Mean
1254390|NCT00474123|Secondary|Triglyceride||Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.||||percentage||Standard Deviation|Mean
1254391|NCT00474123|Secondary|LDL Cholesterol||Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.||||percentage||Standard Deviation|Mean
1254392|NCT00474123|Primary|Interleukin-6|A commercial ELISA assay detecting IL-6 (Siemens, USA) was applied.|Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.||||percentage||Inter-Quartile Range|Median
1254393|NCT00474123|Primary|Soluble CD40 Ligand|A commercial ELISA assay detecting sCD40L (R&D Systems, USA) was applied. Detection limits and intra-assay variability was respectively, as follows: sCD-40L 15.6 pg/mL (intra-assay variability not available).|Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.||||percentage||Standard Deviation|Mean
1254394|NCT00474123|Primary|Soluble Intercellular Adhesion Molecule (sICAM)-1|serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R&D Systems, Europe, Abingdon, UK)|Change from baseline at 6 weeks|per protocol|||percentage||Standard Deviation|Mean
1254395|NCT00474123|Primary|Monocyte Chemoattractant Protein (MCP)-1|Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R&D Systems, Europe, Abingdon, UK).|Change from baseline at 6 weeks|per protocol|||percentage||Standard Deviation|Mean
1254396|NCT00474123|Primary|Platelet Function Analyzer [PFA]-100|Samples were collected in 3.8% sodium citrate (buffered, pH 5.5, Vacutainer, Becton Dickinson, Plymouth, UK) for platelet function tests. Platelet function assays were processed within 2 hours of blood collection. The PFA-100 records the closure time (CT), witch means the time in seconds (s) from the start of the test until the platelet plug occludes the aperture.|Change from baseline at 6 weeks|per protocol|||Percentage||Standard Deviation|Mean
1254397|NCT00474123|Primary|Oxidized Low-Density Lipoprotein Cholesterol|Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting oxLDL (Mercodia, USA) were applied.|Change from baseline at 6 weeks|per protocol|||Percentage||Standard Deviation|Mean
1254398|NCT00474123|Primary|C-reactive Protein|Serum was separated by centrifugation from the blood samples. For high-sensitivity C-Reactive Protein measurement, whole venous blood was collected in tubes without anticoagulant and centrifuged at room temperature. Serum C-Reactive Protein was assessed with a high-sensitivity, latex microparticle-enhanced immunoturbidimetric assay (Behring Nephelometer Analyzer System; Behring Diagnostics, Somerville, NJ).|Change from baseline at 6 weeks|per protocol|||Percentage||Inter-Quartile Range|Median
1254399|NCT00474058|Secondary|Change in Number of Nocturias|Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS).|||nocturias||Standard Deviation|Mean
1254400|NCT00474058|Secondary|Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)|Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS).|||units on a scale||Standard Deviation|Mean
1254401|NCT00474058|Primary|Change in Parkinson's Disease Sleep Scale (PDSS)|The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1254402|NCT00474058|Primary|Change in Early Morning UPDRS Part III Score|The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1254404|NCT00474045|Secondary|Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||ratio||Full Range|Median
1254405|NCT00474045|Secondary|Safety - Composite Pregnancy Outcome|Wt. corresponds to weight of live-born infants. Pre-term delivery: delivery before 37 completed GWs including abortions. Early foetal death: death before 22 completed GWs. Perinatal mortality: death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal mortality: post-partum after 7 completed days and before 28 completed days after delivery. Major-malformation: a life threatening structural anomaly or one likely to cause significant impairment of health or functional capacity and needs medical or surgical treatment.|End of Pregnancy|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and pregnant during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became pregnant again).|||participants|||Number
1254406|NCT00474045|Secondary|Safety - Total Daily Insulin Dose During Pregnancy||Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||U/kg||Standard Deviation|Mean
1254407|NCT00474045|Secondary|Pregnancy Outcome at Follow-Up|Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Perinatal Death means death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal Death means death between at or after 7 completed days and before 28 completed days after delivery. Death During Follow-Up means death between at or after 28 days after delivery and at or before Follow-Up.|Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and preg. during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became preg. again). Analysed subjects-no. of subjects with a preg. outcome at delivery visit.|||participants|||Number
1254408|NCT00474045|Secondary|Pregnancy Outcome at Delivery|Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Stillbirth indicates death between at or after 22 GW and at or before delivery.|Delivery Visit|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and preg. during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became preg. again). Analysed subjects-no. of subjects with a preg. outcome at delivery visit.|||participants|||Number
1254409|NCT00474045|Secondary|Maternal Safety - Mode of Delivery|Non-Planned Caesarean Section is a procedure which takes place ≤8h prior to delivery. Planned Caesarean Section takes place >8h prior to delivery.|At Delivery Visit|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. This set in total contains 152 subjects in IDet and 158 subjects in NPH arm. The partcipant analysed for this outcome measure are the number of subjects at delivery visit.|||percentage (%) of subjects|||Number
1254410|NCT00474045|Secondary|Maternal Safety - Acceleration of Nephropathy|Acceleration of nephropathy was defined as a change from a low U-albumin:U-creatinine ratio ≤33.93 mg/mmol to a high U-albumin:U-creatinine ratio > 33.93 mg/mmol from GW 8-12 (Visit P1) to the follow-up visit.|From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Acceleration of nephropathy was summarised by treatment and missing data was imputed using LOCF.|||participants|||Number
1254411|NCT00474045|Secondary|Maternal Safety - Acceleration of Retinopathy in Any Eye|Acceleration of Retinopathy is defined as worsening of fundoscopy/fundusphotography findings from GW 8-12 (Visit P1) to follow-up on one or both eyes.|From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Acceleration of retinopathy was summarised by treatment and missing data was imputed using LOCF.|||participants|||Number
1254412|NCT00474045|Secondary|Maternal Safety - Electrocardiogram (ECG)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' (at Visit 1, 3 weeks before randomisation) to 'Abnormal, clinically significant' (at Follow-Up). 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||participants|||Number
1254413|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up|Change in the pulse was summarised by treatment.|Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.|||beats/minute||Standard Deviation|Mean
1254414|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit|Change in the diastolic blood pressure was summarised by treatment.|Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.|||mmHg||Standard Deviation|Mean
1254415|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit|Change in the systolic blood pressure was summarised by treatment.|Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.|||mmHg||Standard Deviation|Mean
1264908|NCT00398411|Secondary|Type of Isolates and Infections||end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)|||participants|||Number
1254416|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit|Change in the body weight was summarised by treatment.|Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.|||kg||Standard Deviation|Mean
1254417|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood||At Delivery|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. IDet in cord blood was analysed for subjects in the IDet Arm and only for 98 subjects, as for 72 subjects it was reported as below measuring range (<25.00 pmol/L).|||pmol/L||Full Range|Median
1254418|NCT00474045|Secondary|Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||ratio||Full Range|Median
1254419|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
1254420|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T)|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
1254421|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
1254422|NCT00474045|Secondary|Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies|Change in concentrations values for insulin detemir/aspart cross-reacting antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
1254423|NCT00474045|Secondary|Maternal Safety - Change in Insulin Aspart Specific Antibodies|Change in concentrations values for insulin aspart specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
1254424|NCT00474045|Secondary|Maternal Safety - Change in Insulin Detemir Specific Antibodies|Change in concentrations of values for insulin detemir specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
1254425|NCT00474045|Secondary|Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in Urine-N (creatinine) level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mg/dL||Standard Deviation|Mean
1254426|NCT00474045|Secondary|Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in albumin/creatinine ratio at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mg/mmol||Standard Deviation|Mean
1254427|NCT00474045|Secondary|Maternal Safety - Change in Urine Albumin Level (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in urine albumin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||g/dL||Standard Deviation|Mean
1254428|NCT00474045|Secondary|Maternal Safety - Change in Thrombocytes Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in thrombocytes level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||10^9 cells/L||Standard Deviation|Mean
1254429|NCT00474045|Secondary|Maternal Safety - Change in Leukocytes Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in leukocytes level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||10^9 cells/L||Standard Deviation|Mean
1254430|NCT00474045|Secondary|Maternal Safety - Change in Haemoglobin Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in haemoglobin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
1254431|NCT00474045|Secondary|Maternal Safety - Change in Total Protein Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in total protein serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.Missing data was imputed using LOCF.|||g/dL||Standard Deviation|Mean
1254432|NCT00474045|Secondary|Maternal Safety - Change in Sodium Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in sodium serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
1254433|NCT00474045|Secondary|Maternal Safety - Change in Potassium Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in potassium serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
1254434|NCT00474045|Secondary|Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in lactate dehydrogenase serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||U/L||Standard Deviation|Mean
1254435|NCT00474045|Secondary|Maternal Safety - Change in Creatinine Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in creatinine serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mcmol/L||Standard Deviation|Mean
1254436|NCT00474045|Secondary|Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alkaline phosphatase level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||U/L||Standard Deviation|Mean
1254437|NCT00474045|Secondary|Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alanine aminotransferase level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||U/L||Standard Deviation|Mean
1254438|NCT00474045|Secondary|Maternal Safety - Change in Albumin Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in albumin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||g/dL||Standard Deviation|Mean
1254439|NCT00474045|Secondary|Maternal Safety - Nocturnal Hypoglycaemic Episodes|A nocturnal episode is any episode occurring between 0.01 - 5.59, both including. It includes major, minor and symptoms only episodes. Major: unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||episodes|||Number
1254440|NCT00474045|Secondary|Maternal Safety - Hypoglycaemic Episodes|All episodes include major, minor and symptoms only. Major episode : unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. Diurnal: Episode occurring between 06.00 - 00.00, both including.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||episodes|||Number
1254453|NCT00473876|Secondary|Possible Mechanisms That Can Explain the Improvement of Exercise Capacity|VE/VCO2 Slope, measurement of the abnormal ventilatory response to exercise identified by an increased slope of ventilation (L/min) vs. CO2 production (VE/VCO2) (L/min) to incremental workload|4 months|39 patients were randomized with 3 dropped out. Therefore, 36 were included in the analysis. There was 1 patient who dropped out in the placebo arm and hence 22 patients were analysed.|||Unitless||Standard Deviation|Mean
1254441|NCT00474045|Secondary|Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events|AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. SAE=any undesirable serious medical event as defined in protocol.|Foetuses/Newborns were followed during the pregnancy period, an average of 9.6 months and Follow-Up period (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Each pregnant woman analyzed had exactly one Foetus/Newborn that was analyzed for AEs.|||Foetus/Newborns (1 per pregnant woman)|||Number
1254442|NCT00474045|Secondary|Maternal Safety - Number of Subjects With Adverse Events (AEs)|AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. Serious adverse event (SAE) =any undesirable serious medical event as defined in protocol.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||participants|||Number
1254443|NCT00474045|Secondary|8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36|8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.|Visit P4 (GW 36)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 & NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the average values.|||mmol/L||Standard Deviation|Mean
1254444|NCT00474045|Secondary|8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24|8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.|Visit P3 (GW 24)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 & NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the average values.|||mmol/L||Standard Deviation|Mean
1254445|NCT00474045|Secondary|Fasting Plasma Glucose (FPG)||During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.|||mmol/L||Standard Deviation|Mean
1254446|NCT00474045|Secondary|Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36||At both Visit P3 (GW 24) and Visit P4 (GW 36)|FAS for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using LOCF which was made using pregnancy visits, early termination visit and withdrawal visit. Analysed subjects-subjects with valid HbA1c values at visit P3 and P4.|||participants|||Number
1254447|NCT00474045|Secondary|Glycosylated Haemoglobin (HbA1c) During Pregnancy||During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Delivery Visit (end of pregnancy)] and Follow-Up Visit ( 6 weeks after delivery)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1254448|NCT00474045|Primary|Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36||At gestational week (GW) 36|Per Protocol Analysis Set (pregnant subjects): comprised all subjects from the FAS (pregnant subjects) except subjects who significantly violated the inclusion/exclusion criteria. Gestational age at delivery must be at least 32 completed weeks.|||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
1254449|NCT00474045|Primary|Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36||At gestational week (GW) 36|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.|||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
1254450|NCT00473889|Secondary|Number of Participants Who Had a Disease Response to Treatment|Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions).|Every 42 days from start of treatment until disease response|"Full analysis set~(FAS) population is defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study. Five (5) didn't take any study medication. Therefore, 248 participants are included in this analysis population."|||Participants|||Number
1254451|NCT00473889|Secondary|Progression Free Survival|Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions.|Start of treatment to disease progression or death|"Full analysis set~(FAS) population defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study 5 didn't take any study medication. Therefore, 248 participants are included in this analysis population."|||Months||Full Range|Median
1254452|NCT00473889|Primary|Overall Survival|Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.|Start of treatment to death|Intention-to-treat (ITT) population is defined as all randomized participants. Participants are counted in the group to which they are randomized.|||Months||Full Range|Median
1254454|NCT00473876|Primary|Peak VO2|Peak VO2 after 4 months of intervention with either metformin or placebo. The Mean difference between baseline and after 4 months was analyzed using t-test comparing metformin and placebo.|4 months|.In the metformin group,3 patients were lost to follow up therefore excluded from analysis.5 patients were discontinued on medications due to side effects, however,were included in our intention to treat analysis.In the placebo group,1 patient was lost to follow up and was excluded from analysis|||ml/kg/min||Standard Deviation|Mean
1254455|NCT00473837|Secondary|Curve of Hb Change Between Day 3 and Day 30 in the Two Placebo Arms; Changes in Markers of Iron Status, Measures of Inflammation, and Hb Response Between Day 3 and Day 30, and Between Day 3 and Day 90||90 days|||||||
1254456|NCT00473837|Primary|Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms||90 days||||g/L||Standard Deviation|Mean
1254457|NCT00473824|Primary|Post Transplant Reduction in Viral Load (as Measured Quantitatively by Hepatitis C Virus (HCV) Reverse Transcription-Polymerase Chain Reaction (HCV RT-PCR)).|Proportion of subjects who achieve reduction in viral load from the baseline pre-transplant value. Baseline is the pre-transplant HCV viral load as measeured by RT-PCR. Post-transplant HCV viral load is determined at both 1 month and 6 months post-tranplant.|Outcome evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant.|As the study was terminated early and since no participant in either arm achieved reduction in viral load, it was recorded that zero particpants and zero percent in each arm achieved reduction in viral load.|||percentage of participants|||Number
1254458|NCT00473746|Secondary|Phase 2: Duration of Objective Response|Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic duration of objective response.|||days||95% Confidence Interval|Median
1254459|NCT00473746|Secondary|Phase 2: Overall Survival|Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause.|Up to Month 60|ITT population included all participants who were enrolled into the study.|||days||95% Confidence Interval|Median
1254460|NCT00473746|Secondary|Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score|ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3=capable of limited self-care, confined to bed or chair >50% of waking hours. 4=completely disabled, not capable of any self-care, totally confined to bed or chair. 5=dead.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.|||participants|||Number
1254461|NCT00473746|Secondary|Phase 2: Duration of PSA Response|Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.|||days||95% Confidence Interval|Median
1254462|NCT00473746|Secondary|Phase 2: Time to PSA Progression|The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.|||days||95% Confidence Interval|Median
1254463|NCT00473746|Secondary|Phase 2: Radiographic Objective Response Rate (RAD-ORR)|The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic objective response rate.|||participants|||Number
1254464|NCT00473746|Secondary|Phase 2: PSA Progression Free Survival (PSA-PFS)|PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.|||days||95% Confidence Interval|Median
1254465|NCT00473746|Secondary|Phase 2: Radiographic Progression Free Survival (RAD-PFS)|RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study. RAD-PFS was not analyzed because of insufficient data to provide a meaningful estimate of the median and associated confidence interval (CI)|||days||Full Range|Median
1254466|NCT00473746|Secondary|Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||Liter (L)||Standard Deviation|Mean
1254467|NCT00473746|Secondary|Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||liter per hour (l/hr)||Standard Deviation|Mean
1254468|NCT00473746|Secondary|Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||hour (hr)||Standard Deviation|Mean
1254469|NCT00473746|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||hr*nmol/L||Standard Deviation|Mean
1254470|NCT00473746|Secondary|Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||hr*nmol/L||Standard Deviation|Mean
1254471|NCT00473746|Secondary|Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose)|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||hour (hr)||Standard Deviation|Mean
1254472|NCT00473746|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.|ITT population included all participants who were enrolled into the study.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
1254473|NCT00473746|Primary|Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)|Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement.|Up to 12 weeks from start of treatment|Intent-to-treat (ITT) population included all participants who were enrolled into the study.|||participants|||Number
1254474|NCT00473746|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate|The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects.|Up to Cycle 12|Safety population included all enrolled participants who received any study drug. MTD of abiraterone acetate was not reached because the doses administered appear to be well tolerated with no Dose Limiting Toxicity (DLT) even at 1000 milligram per day (mg/day [recommended maximum dose for phase 1]) and 1000 mg/day was taken as test dose in phase 2.|||mg/day|||Number
1254475|NCT00473668|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0-Month 3)|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
1254476|NCT00473668|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
1254477|NCT00473668|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade. Grade 3 Irritability= crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness/Loss of appetite= Drowsiness/Loss of appetite that prevented normal activity. Grade 3 fever = fever above (>) 39.5°C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0–3) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
1254498|NCT00473655|Primary|Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)|Reduction from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
1256725|NCT00457730|Primary|Percent Change in Worst Pain Score|Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.|at week 6||||percent reduction on 0-10 analog scale||Standard Deviation|Mean
1254478|NCT00473668|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Day 0–3) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
1254479|NCT00473668|Secondary|Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1254480|NCT00473668|Secondary|Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1254481|NCT00473668|Secondary|Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1254482|NCT00473668|Secondary|Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1254483|NCT00473668|Secondary|Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen|Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration.|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
1254484|NCT00473668|Secondary|Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen|A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
1254485|NCT00473668|Secondary|Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens|Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available|||Subjects|||Number
1254486|NCT00473668|Secondary|Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off|Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells.|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
1254487|NCT00473668|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
1254488|NCT00473668|Secondary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
1254489|NCT00473668|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens|A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Participants|||Count of Participants
1254490|NCT00473655|Secondary|ApoB Levels|Change in the levels from baseline to end of study|8 weeks||||mg/dl||Standard Deviation|Mean
1254491|NCT00473655|Secondary|Adverse Events Reported|Number of participants with AEs and SAEs reported|8 weeks||||Participants|||Number
1254492|NCT00473655|Secondary|hsCRP Reduction|Reduction from baseline to end of study|8 weeks||||mg/L||Standard Deviation|Mean
1254493|NCT00473655|Secondary|ApoA1 Levels|Change in the levels from baseline to end of study|8 weeks||||mg/dl||Standard Deviation|Mean
1254494|NCT00473655|Secondary|HDL-C Increase|Increase from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
1254495|NCT00473655|Secondary|Total Cholesterol Reduction|Reduction from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
1254496|NCT00473655|Secondary|LDL-C Reduction|Reduction from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
1254497|NCT00473655|Secondary|Non-HDL-C Reduction|Reduction from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
1288227|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48||Month 48||||L||Standard Error|Mean
1254499|NCT00473642|Primary|Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol|Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study, the number of letters gained over the course of the study. In other words the baseline visual acuity in letters was subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.|12 months||||letters||Standard Deviation|Mean
1254500|NCT00473642|Secondary|Time to First Retreatment After Loading Doses, Average Number of Retreatments Over 12 Months, Central Macular Thickness on OCT, the Number of Recurrent CNV, the Number of Patients With Persistent CNV After the Mandatory Loading Doses.||12 months|||||||
1254501|NCT00473642|Primary|Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months||12 months|||||||
1254502|NCT00473590|Secondary|Number of Participants With Selected Adverse Events (AEs)|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All serious adverse events are listed in the Adverse Event Reporting section.|Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).|Safety population: all patients who were randomized and received any amount of study treatment. Two patients who randomized to the BORT + P arm received at least 1 dose of bevacizumab and were analyzed as bevacizumab-treated patients. Therefore, the safety analysis included 50 patients in the BORT + P arm and 50 patients in the BORT + BV arm.|||Participants|||Number
1254503|NCT00473590|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from randomization to disease progression or death on study from any cause within 30 days of the last response assessment. Disease progression was determined by the investigator using the International Myeloma Working Group's (IMWG) uniform response criteria. Median PFS was estimated using Kaplan-Meier methodology. For patients who were alive at the time of the analysis and whose disease had not yet progressed, PFS was censored at the time of the last response assessment.|From randomization to disease progression or death on study (up to 116 weeks).|Randomized Patients|||months||95% Confidence Interval|Median
1254504|NCT00473590|Secondary|Overall Survival (OS)|Overall survival was defined as the duration of time from randomization until death from any cause. All deaths were included, whether they occurred on study treatment or following treatment discontinuation. Overall survival was estimated using Kaplan-Meier. For patients who had not died, overall survival was censored at the date that the patient was last known to be alive.|From randomization until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients|||Months||95% Confidence Interval|Median
1254505|NCT00473590|Secondary|Duration of Response|Duration of response was defined as the time from the initial response to disease progression or death on study. Disease progression was determined by the investigator using the IMWG’s uniform response criteria and defined as an increase of ≥25% from best response in: Serum M-protein and/or Urine M-protein and/or Marrow plasma cells; or new or increased plasmacytomas or bone lesions; or hypercalcemia due to myeloma. Duration of response was estimated using Kaplan-Meier. For patients who had not progressed or died, duration of response was censored at the date of the last response assessment.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients with an overall response|||Months||95% Confidence Interval|Median
1254506|NCT00473590|Secondary|Percentage of Participants With an Overall Response|Overall response was defined as a stringent complete response, complete response, very good partial response, or partial response (sCR, CR, VGPR, and PR) determined on two consecutive assessments ≤ 6 weeks apart and before the initiation of any new anti-tumor therapy, as assessed by the investigator using the IMWG's uniform response criteria. Patients without a post-baseline response assessment or who died prior to their first scheduled response assessment were considered non-responders.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients|||Percentage of Participants||95% Confidence Interval|Number
1254507|NCT00473590|Secondary|Number of Participants With an Overall Response|Overall response was defined as a stringent complete response, complete response, very good partial response, or partial response (sCR, CR, VGPR, and PR, respectively) determined on two consecutive assessments ≤ 6 weeks apart and before the initiation of any new anti-tumor therapy, as assessed by the investigator using the International Myeloma Working Group’s (IMWG's) uniform response criteria. Patients without a post-baseline response assessment or who died prior to their first scheduled response assessment were considered non-responders.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients|||participants|||Number
1254508|NCT00473564|Secondary|Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.|Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins|3 - 24 months postoperatively|Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System|||participants|||Number
1254509|NCT00473564|Primary|Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions|Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions|Intraoperatively average of 2 hours||||participants|||Number
1254510|NCT00473512|Other Pre-specified|Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone|The actual sampling time of last measurable (non-below the limit of quantification [BQL]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Data was not statistically summarized but reported in individual participant listing as per planned analysis.||||||
1254890|NCT00468910|Secondary|Rectal Prostaglandin Levels as Measured by ELISA|Evaluate the effect of aspirin on rectal prostaglandin levels.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||pg/ml||Standard Deviation|Mean
1254511|NCT00473512|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Abiraterone|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hour||Standard Deviation|Mean
1254512|NCT00473512|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours*nmol/L||Standard Deviation|Mean
1254513|NCT00473512|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone|Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast).|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours*nmol/L||Standard Deviation|Mean
1254514|NCT00473512|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone|The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours||Standard Deviation|Mean
1254515|NCT00473512|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Abiraterone|The Cmax is defined as maximum observed analyte concentration.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||nmol/L||Standard Deviation|Mean
1254516|NCT00473512|Other Pre-specified|Mean Plasma Concentration of Abiraterone||Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Data was not statistically summarized but reported in individual participant listing as per planned analysis.||||||
1254517|NCT00473512|Other Pre-specified|Number of Participants With Change From Baseline in Biochemical Bone Markers||Baseline, Cycle 2, 4, 8, 12|Data was reported in individual participant listings but not summarized due to statistical constraints.||||||
1254518|NCT00473512|Other Pre-specified|Time to Prostate Cancer Pain Progression|The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of >= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method.|Baseline up to 12 cycles|Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.||||||
1254519|NCT00473512|Other Pre-specified|Serum Blood Levels of Testosterone Precursors|Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL).|Baseline, Cycle 2 (within 3 days prior to Day 29)|All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.|||ng/dL||Full Range|Median
1254520|NCT00473512|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose of study medication|Included all participants who received any amount of the study medication.|||participants|||Number
1254521|NCT00473512|Other Pre-specified|Serum Blood Levels of Testosterone|Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL).|Baseline, Cycle 2 (within 3 days prior to Day 29)|All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.|||ng/dL||Full Range|Median
1254522|NCT00473512|Secondary|Overall Survival|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|Baseline up to end of study (1160 days)|Data was not analyzed due to high number of participants censored for survival.||||||
1254523|NCT00473512|Secondary|Time to Disease Progression|Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline.|Baseline up to end of study (1160 days)|Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression.||||||
1254524|NCT00473512|Secondary|Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to end of study (1160 days)|Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up.||||||
1254525|NCT00473512|Secondary|Duration of Prostate Specific Antigen (PSA) Response|Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria.|Baseline up to end of study (1160 days)|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Days||Full Range|Median
1254526|NCT00473512|Secondary|Number of Participants With Objective Tumor Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to end of study (1160 days)|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1254527|NCT00473512|Primary|Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12|The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.|Baseline, Week 12|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1254528|NCT00473434|Secondary|The Length of Hospitalizations Throughout the Study||52 weeks|Participants who were hospitalized and had evaluable data at each measurement time point|||days||Standard Deviation|Mean
1254529|NCT00473434|Secondary|The Number of Hospitalizations Throughout the Study|This outcome measure is intended to document all hospitalizations that occurred throughout the study.|52 Weeks|All participants with evaluable data at each measurement time point|||events|||Number
1254530|NCT00473434|Secondary|The Percentage of Participants Presenting Clinical Deterioration Throughout the Study|This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms.|52 Weeks|All participants with evaluable data at each measurement time point|||percentage of participants|||Number
1254531|NCT00473434|Secondary|The Global Assessment of Functioning (GAF) Throughout the Study|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|52 Weeks|All participants with evaluable data at each measurement time point|||scores on a scale||Standard Deviation|Mean
1254532|NCT00473434|Secondary|The Clinical Global Impression of Severity (CGI-S) Throughout the Study|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients."|52 weeks|All participants with evaluable data at each measurement time point|||scores on a scale||Standard Deviation|Mean
1254533|NCT00473434|Primary|The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12||Week 0 to Week 12|Intent-To-Treat (ITT) population|||mg||95% Confidence Interval|Median
1254534|NCT00473434|Primary|The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12||Week 0 to Week 12|Intent-To-Treat (ITT) population|||mg||Standard Deviation|Mean
1254535|NCT00473434|Primary|The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84||Day 57 to Day 84|Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57|||mg||95% Confidence Interval|Median
1254536|NCT00473434|Primary|The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84||Day 57 to Day 84|Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57|||mg||Standard Deviation|Mean
1254537|NCT00473434|Primary|The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84||Day 1 to Day 84|Intent-To-Treat (ITT) population|||mg||95% Confidence Interval|Median
1254538|NCT00473434|Primary|The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84||Day 1 to Day 84|Intent-To-Treat (ITT) population|||mg||Standard Deviation|Mean
1254539|NCT00473382|Secondary|Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||µm||Standard Deviation|Mean
1288228|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42||Month 42||||L||Standard Error|Mean
1254540|NCT00473382|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
1254541|NCT00473382|Secondary|Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Letters||Standard Deviation|Mean
1254542|NCT00473382|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
1254543|NCT00473382|Secondary|Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36|The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Treatments||Standard Deviation|Mean
1254544|NCT00473382|Secondary|Percentage of Patients With Resolution of Leakage at Month 24|Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
1254545|NCT00473382|Secondary|Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36|The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
1254546|NCT00473382|Secondary|Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||µm||Standard Deviation|Mean
1254547|NCT00473382|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 36|Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Letters||Standard Deviation|Mean
1254548|NCT00473382|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
1254568|NCT00473265|Secondary|Trabecular Width|Trabecular width was obtained from histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular width is the thickness of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.|||micrometers||Standard Deviation|Mean
1289127|NCT00135707|Secondary|Gestational Age at Delivery||Delivery||||weeks||Standard Deviation|Median
1254549|NCT00473382|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Months 24, 36, and 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
1254550|NCT00473382|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Letters||Standard Deviation|Mean
1254551|NCT00473382|Primary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.|||Percentage of patients||95% Confidence Interval|Number
1254552|NCT00473330|Secondary|Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||µm||Standard Deviation|Mean
1254553|NCT00473330|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of participants||95% Confidence Interval|Number
1254554|NCT00473330|Secondary|Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Letters||Standard Deviation|Mean
1254555|NCT00473330|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
1254556|NCT00473330|Secondary|Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36|The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Treatments||Standard Deviation|Mean
1254557|NCT00473330|Secondary|Percentage of Patients With Resolution of Leakage at Month 24|Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
1254569|NCT00473265|Secondary|Percent Change in BMD From Baseline to 24 Months by DXA|Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA).|baseline versus 24 months|Only the first 30 participants who completed 24 months of the study were analyzed|||percentage of change to BMD||Standard Deviation|Mean
1254570|NCT00473265|Primary|Requirements for Calcium Supplementation|Serum and urinary calcium levels maintained by change in requirements for calcium supplementation|2 years|Only the first 30 participants to complete 24 months in the study were analyzed|||grams per day of calcium supplementation||Standard Deviation|Mean
1254571|NCT00473083|Primary|Overall Incidence of Grade 3 Rash|"The overall incidence of grade 3 erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group."|From onset of rash until resolution, up to 4 weeks following progression, on average of 1 year||||percentage of participants|||Number
1254558|NCT00473330|Secondary|Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36|The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
1254559|NCT00473330|Secondary|Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||µm||Standard Deviation|Mean
1254560|NCT00473330|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 36|Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Letters||Standard Deviation|Mean
1254561|NCT00473330|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
1254562|NCT00473330|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Months 24, 36, and 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
1254563|NCT00473330|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Letters||Standard Deviation|Mean
1254564|NCT00473330|Primary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.|||Percentage of patients||95% Confidence Interval|Number
1254565|NCT00473265|Secondary|Mineralizing Surface|Mineralizing surface done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Mineralizing surface measures how much of bone is getting new mineral put on it. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus one year|Only 14 subjects had paird bone biopsies obtained at baseline and after 12 months of PTH(1-84) treatment.|||percentage of surface||Standard Deviation|Mean
1254566|NCT00473265|Secondary|Cortical Porosity|Cortical porosity done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Cortical Porosity measures how many tiny holes there are in the solid bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.|||percentage of porosity||Standard Deviation|Mean
1254567|NCT00473265|Secondary|Trabecular Number|trabecular number done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular number is the number of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.|||mm^-1||Standard Deviation|Mean
1288229|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42||Month 42||||L||Standard Error|Mean
1254575|NCT00473083|Secondary|Severity of Rash Caused by Erlotinib|The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash.|Onset until resolution, up to 4 weeks following progression, on average of 1 year|Arm 1 (n=42), Arm 2 (n=42), Arm 3, (n=41)|||percentage of participants|||Number
1254576|NCT00473083|Primary|Time Duration From Onset of Rash Until Resolution|"To investigate if the rash caused by erlotinib is self-limiting.~A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.~The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.~The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2."|From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year|"Patients With Maximum Severity of Rash Grade 1, 2b: Arm 1 (n=36), Arm 2 (n=38), Arm 3 (n=27)~Patients With Maximum Severity of Rash Grade 3: Arm 1 (n=6), Arm 2 (n=4), Arm 3 (n=14)"|||days||Inter-Quartile Range|Median
1254577|NCT00473083|Primary|Overall Incidence of Rash|"The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group."|From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year||||percentage of participants|||Number
1254578|NCT00472849|Primary|Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days)|Maximum dose levels for Phase I determined among three possible dose levels of Fludarabine and Cytarabine in combination with fixed doses of Oxaliplatin and Rituximab. Fludarabine and Cytarabine Dose Level 1: Days 2-3 (2 Days); Dose Level 2: Days 2-4 (3 Days); and Dose 3: Days 2-5 (4 Days). MTD is dose level at which less than 2/3 or 2/6 participants experience dose limiting toxicities (DLTs). The number of days of fludarabine and cytarabine administration increased simultaneously. Participants received a subsequent cycle of treatment with 1 additional day of fludarabine and cytarabine treatment no less than 4 weeks from the initiation of the previous cycle if no drug-related grade 3 or 4 non-hematologic life-threatening adverse events, and drug-related non-hematologic toxicity resolved to baseline or < grade 2. A maximum of 6 cycles were administered.|Up to 36 weeks (6 cycles each 4-6 weeks)||||mg/m^2|||Number
1254579|NCT00472849|Secondary|Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission|Overall Response includes Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) in high-risk, previously untreated participants with Chronic Lymphocytic Leukemia treated with CFAR using National Cancer Institute - Working Group response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.|Up to 36 weeks (6 cycles each 4-6 weeks)||||participants|||Number
1254580|NCT00472797|Other Pre-specified|SF-36 Physical and Mental Component Scores|Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10.|Change from Baseline to Each Visit|ITT|||Score||Standard Deviation|Mean
1254581|NCT00472797|Secondary|Tolerability - Redness at Injection Site|Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better.|Baseline to Week 12 (LOCF)|ITT and LOCF|||mm||Standard Deviation|Mean
1254582|NCT00472797|Secondary|Tolerability in Pain Using Visual Analog Scale (VAS)|The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.|Baseline to Week 12|ITT|||Participants|||Number
1254583|NCT00472797|Secondary|Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12|The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain).|Baseline to Week 12|ITT and LOCF|||score on scale||Standard Deviation|Mean
1254584|NCT00472797|Secondary|Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)|The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 – score at baseline.|Baseline to Week 12||||score on scale||Standard Deviation|Mean
1254585|NCT00472797|Secondary|Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)|The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).|Baseline and Week 12|Intent to Treat (ITT) and Last Observation Carried Forward (LOCF) Higher scores indicate a more favorable response|||score on scale||Standard Deviation|Mean
1254586|NCT00472797|Primary|Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)|The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% * (score at week 12 – score at baseline) / score at baseline.|% change from Baseline to Week 12|Safety: This population includes all subjects who received at least one dose of study drug. To explain difference in number, 1 subject lost to follow-up, 1 subject withdrew consent|||percent change||Standard Deviation|Mean
1289128|NCT00135707|Secondary|Maternal Hospital Stay||Delivery through discharge||||days||Inter-Quartile Range|Median
1254587|NCT00472732|Primary|Fractional Anisotropy|Measure of white matter integrity in OTCD Patients and Controls in frontal white matter. Fractional anisotropy values fall on a scale of 0 to 1, with 0 meaning that the diffusion of water is isotropic and unrestricted, or equally restricted, in all directions and with 1 meaning that diffusion occurs along only one axis and is fully restricted along all other directions. Scores closer to 1 are associated with intact white matter while scores closer to 0 are associated with white matter damage.|one time measurement at study baseline|Five OTCD Patients and four healthy controls were excluded due to excessive head motion.|||units on a scale||Standard Deviation|Mean
1254588|NCT00472732|Primary|Functional MRI Activation in N-Back Tast|"Measure of blood oxygen level dependent (BOLD) signal of OTCD patients and healthy controls during an N-Back task comparing 2-back and 1-back conditions. This contrast was created for each participant using SPM and then entered into a group analysis in which we compare percent signal change between groups. Therefore, we never see BOLD signal change at the individual level, which is why we never see scores or numbers at the individual level and we cannot calculate a measure of dispersion for this data."|one time measurement at study baseline|Five OTCD patients and one healthy control were excluded due to excessive head motion.|||percent signal change|||Number
1254589|NCT00472732|Primary|Concentration of Glutamine and Myoinositol by MRS|"Concentration based on area under curve on 1H MRS and quantitated by LCModel. A metabolite’s tissue concentration is related to the integrated amplitude of the MRS signal it produces. Integrated amplitude is the area under the MRS signal curve. While MRS signals are usually acquired in the time domain as free induction decays or echoes, they are usually viewed and analyzed in the frequency domain. The frequency domain representation is derived from the acquired time domain data by the Fourier Transform. The protocol we use selects 257 averages. This means, 257 free induction decays. The machine summates the data at each time point to generate one value for the area under the curve. Therefore, we don’t have the measurement at each time point.~Furthermore, we measured voxels in two different brain areas containing different kinds of brain matter: one voxel was located in posterior cingulate gray matter (PCGM) and the other in parietal white matter (PWM)."|one time measurement at study baseline||||mM||Standard Deviation|Mean
1254590|NCT00472641|Secondary|Changes From Baseline to Endpoint in Body Mass Index (BMI)|Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI).|Baseline, 12 weeks||||kg/m^2||Standard Deviation|Mean
1254591|NCT00472641|Primary|The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.|The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.|Baseline, 12 weeks||||Pounds||Standard Deviation|Mean
1254592|NCT00472576|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.|Measured daily for 12 days, where the endpoint is the primary outcome|The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.|||Score on a scale||Standard Error|Least Squares Mean
1254593|NCT00472576|Secondary|Hamilton Depression Rating Scale (HDRS)|The Hamilton Depression Rating Scale (HDRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 17 item version range from 0 to 52. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is primary.|Measured daily for 12 days, where the endpoint is primary|The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.|||Score on a scale||Standard Error|Least Squares Mean
1254594|NCT00472446|Secondary|Hospital Stay|time from surgery to Hospital release in days|90 days||||days||Standard Deviation|Mean
1254595|NCT00472446|Secondary|Mean Consumption of Post-operative Analgetics|mean pooled dose of post-operative analgetics|5 days after surgery||||gram||Standard Deviation|Mean
1254596|NCT00472446|Secondary|Consumption of Post-operative Analgetics|number of participants taking post-operative analgetics|5 days after surgery||||participants|||Number
1254597|NCT00472446|Secondary|Post-operative Pain Measured by Visual Analogue Scale|Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)|24 hours after surgery||||units on a scale||Standard Deviation|Mean
1254598|NCT00472446|Primary|Pooled Relative Treatment Effect of VAS|"Pain was obtained using the visual analog scale (VAS) three times daily for the 4 postoperative days (0 = no pain, 10 = worst imaginable pain)~The pooled relative treatment effect is the probability of values being higher in one group than in another group (ranging from 0 to 1)"|4 days after surgery||||pooled relative treatment effect||95% Confidence Interval|Number
1254599|NCT00472446|Primary|Post-operative Pain Measured by Visual Analogue Scale|Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)|6 hours after surgery||||units on a scale||Standard Deviation|Mean
1254600|NCT00472420|Secondary|Event Free Survival (EFS)|EFS was defined as the median time, in months, from the date of study entry disease progression, relapse, secondary malignancy, death or last contact. Relapse was defined by: a) appearance of any new lesion or a ≥ 50% increase in size of previously involved sites, or b) ≥ 50% increase in GTD of any previously identified LN >1 cm in short axis or in the SPD of more than one LN. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population|||months||95% Confidence Interval|Median
1254601|NCT00472420|Secondary|Progression Free Survival (PFS)|PFS was defined as the median time, in months, from the date of study entry to disease progression, death due to mantle cell lymphoma, or last contact. Progressive disease (PD) was defined by: a) 50% increase from nadir in the SPD of any previously identified abnormal LN, or b) appearance of any new lesion during or at the end of treatment. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.|Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population|||months||95% Confidence Interval|Median
1291470|NCT00113425|Secondary|Change From Baseline in Cysts at Week 16||Baseline and Week 16||||cysts||95% Confidence Interval|Mean
1254602|NCT00472420|Primary|Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)|CR was defined by: a) disappearance of clinical/radiographic evidence of disease, disease-related symptoms, and biochemical abnormalities; b) decrease in lymph nodes (LNs) greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) to less than (<) 1.5 cm, a decrease in LNs 1.1 - 1.5 cm to 1 cm or 75 percent (%) decrease in sum of the products of GTD (SPD); c) non-palpable spleen, decreased size of enlarged organs, and disappearance of nodules; and d) disappearance of bone marrow (BM) infiltrate. CR(u) was defined as fulfilling a) and c), above, with greater than or equal to (≥) 1 of the following: a) > 75% decrease in SPD of LNs > 1.5 cm, and > 75% decrease in SPD of previously confluent LNs; b) indeterminate BM, or c) confirmed CR. PR was defined by: a) 50% decrease in SPD of the 6 largest LNs; b) no increase in LNs, liver, or spleen size; c) ≥ 50% decrease in splenic and hepatic nodule SPDs; d) no measurable disease in other organs; and e) no new sites of disease.|Screening, Baseline (BL), every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population|||participants|||Number
1254603|NCT00472303|Secondary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the maintenance phase. A negative mean change indicates an improvement."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Safety Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.|||units on a scale||Standard Deviation|Mean
1254604|NCT00472303|Secondary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the titration phase."|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Per Protocol Set (Titration Phase), observed. Start of Titration and Endpoint Titration observations.|||units on a scale||Standard Deviation|Mean
1254605|NCT00472303|Secondary|Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase.|"This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.~The following withdrawal categories are based on the total COWS score:~None: total score below 5;~Mild: total score from 5 to 12;~Moderate: total score 13 to 24;~Moderately Severe: total score 25 to 36;~Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication."|Day 43 (End of Maintenance Phase)|Safety Analysis Set. Participants that did not discontinue due to adverse event during the first week of the maintenance phase and started opioid after last study medication.|||participants|||Number
1254606|NCT00472303|Secondary|Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase.|"This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.~The following withdrawal categories are based on the total COWS score:~None: total score below 5;~Mild: total score from 5 to 12;~Moderate: total score 13 to 24;~Moderately Severe: total score 25 to 36;~Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication."|Day 14 (End of Titration Phase)|Safety Analysis Set (Titration Phase). Participants that took at least one dose of trial medication in the titration phase, and discontinued trial medication at the end or during the titration phase and did not continue on other opioid medication.|||participants|||Number
1254607|NCT00472303|Secondary|Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial.|"Participants were asked the following question: Please rate the overall quality of your sleep last night? The quality of sleep from the start of maintenance to the completion of treatment is reported. The participant could choose one of the following options: Excellent, good, fair and poor."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|"FAS (Maintenance Phase) Last Observation Carried Forward for participants re-randomized.~Tapentadol: 105 participants responded at the start and 103 participants at the end.~Morphine: 108 participants responded at the start and 107 participants at the end.~Placebo: 110 participants responded at the start and 107 participants at the end."|||participants|||Number
1254616|NCT00472303|Secondary|The Average Mean Total Daily Dose of Rescue Medication.|Mean total daily dose of rescue medication morphine sulphate immediate release tablets in milligrams per day (mg/day).|Day 1 (Start of Titration Phase) through Day 43 (End of Maintenance Phase)|Full analysis set for each phase of the trial, observed.|||milligrams per day of morphine rescue||Standard Deviation|Mean
1254608|NCT00472303|Secondary|Quality of Sleep (Sleep Questionnaire) in the Titration Phase.|"Participants were asked the following question: Please rate the overall quality of your sleep last night? The quality of sleep from the start of the titration phase to the end of the titration phase was measured. The participant could choose one of the following options: Excellent, good, fair and poor."|Day 1 (Start of Titration); Day 14 (end of Titration Phase)|"Full Analysis Set (Titration Phase), observed. Tapentadol: 302 participants dosed gave a response at the start of titration and from 309 participants at the end of titration.~Morphine: 143 participants dosed gave a response at the start of titration and from 142 participants at the end of titration."|||participants|||Number
1254609|NCT00472303|Secondary|Patient Global Impression of Change|"In the Patient Global Impression of Change (PGIC) the participant is asked Since I began study treatment, my overall status is. The participant is asked to circle one of seven categories. Scores range from very much improved to very much worse. The question was asked at the end of the maintenance phase with reference to the start of the maintenance phase where the participant continued at the dose that was effective at the end of the Titration Phase."|Day 43 (End of Maintenance Phase)|Full Analysis Set, observed.|||participants|||Number
1254610|NCT00472303|Secondary|Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from Day 15, a negative mean value indicates a worsening of health-related quality of life since the start of the maintenance phase.|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.|||units on a scale||Standard Deviation|Mean
1254611|NCT00472303|Secondary|Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms.|"The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).~The responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A negative change in the mean indicates a worsening in health status since the beginning of the maintenance phase. A positive change indicates an improvement in health. The minimal important difference in the Health Status Index is 0.074 (range -0.011 to 0.140)."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations. No morphine treatment analysis was planned.|||units on a scale||Standard Deviation|Mean
1254612|NCT00472303|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate better health. The values indicated represent the change from Day 1, a positive value indicates an improvement since the start of treatment.|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Phase), observed.|||units on a scale||Standard Deviation|Mean
1254613|NCT00472303|Secondary|Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration.|"The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).~The responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A positive change in the mean indicates that during this phase the health status improved. A positive change indicates an improvement in health. The minimal important difference is 0.074 (range -0.011 to 0.140)."|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Phase), observed.|||units on a scale||Standard Deviation|Mean
1254614|NCT00472303|Secondary|Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase.|The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full analysis set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.|||units on a scale||Standard Deviation|Mean
1254615|NCT00472303|Secondary|Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase.|The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Period), observed. Start of Titration and Endpoint Titration observations.|||units on a scale||Standard Deviation|Mean
1254964|NCT00468819|Primary|Plasma Clearance Estimates of Gadobutrol by Age Group|Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.|From injection of Gadobutrol up to 8 hours after injection.|Final pharmacokinetics (PK) analysis set|||L/h||Inter-Quartile Range|Median
1254617|NCT00472303|Secondary|Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase|Participants were issued morphine 10 mg immediate release medication. The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the maintenance phase were counted. This use of morphine immediate release was captured in each participant's electronic diary.|Day 15 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance phase), observed.|||participants|||Number
1254618|NCT00472303|Secondary|Use of Rescue Medication in the Titration Phase.|"The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the titration phase were counted. This data was captured in an electronic diary.~During the trial, morphine immediate release 10 mg was allowed as required without a maximum dose defined. However, participants were only re-randomized if their mean consumption of rescue medication was less or equal to 2 doses (20 mg) per day during the last 3 days of the titration phase)."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration phase), observed.|||participants|||Number
1254619|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the 3 days prior to re-randomization or during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 15 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Period). Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1254620|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Observed, i.e. participants contributing data via their electronic diary.|||units on a scale||Standard Deviation|Mean
1254621|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Phase), observed.|||units on a scale||Standard Deviation|Mean
1254622|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 18 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Period). Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1254623|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Period), observed.|||units on a scale||Standard Deviation|Mean
1254624|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Period), observed.|||units on a scale||Standard Deviation|Mean
1254625|NCT00472303|Primary|Number of Participants Scored as Responder in Maintenance Phase.|"A responder is a participant in the study that:~completed 28 days of the maintenance phase~had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.~did not use more than 20 mg of rescue medication per day on average in the 28 day maintenance period (from Day 18 to Day 43).~A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that failed to meet only 1 of the 3 criteria is not counted as a responder."|Day 18 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase).|||participants|||Number
1254626|NCT00472290|Primary|Incidence of Antibody (AB) Formation||During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks.|Safety analysis includes subjects who took at least one dose of romiplostim.|||Participant|||Number
1254627|NCT00472290|Secondary|Duration of Platelet Response|Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Weeks|Weeks with Platelet Response|Full Range|Median
1254644|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better social functioning|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1292329|NCT00106938|Secondary|Freedom From Mortality||0 to 1095 days||||percentage of partcipants|||Number
1254628|NCT00472290|Secondary|Time to First Platelet Response|Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Weeks|Weeks with Platelet Response|95% Confidence Interval|Median
1254629|NCT00472290|Secondary|Weeks With Platelet Response Per Year|During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Weeks/Subject-year|Weeks with Platelet Response|95% Confidence Interval|Mean
1254630|NCT00472290|Secondary|Platelet Transfusion Events Per 100 Subject Years|During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Events/100 subject-year|Events|95% Confidence Interval|Mean
1254631|NCT00472290|Secondary|Weekly Bleeding Events Per 100 Subject Years|During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Events/100 subject-year|Events|95% Confidence Interval|Mean
1254632|NCT00472290|Primary|Overall Summary of Adverse Events||During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks .|Safety analysis includes subjects who took at least one dose of romiplostim.|||Participant|||Number
1254633|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Pulse Rate||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||bpm||Standard Deviation|Mean
1254634|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Pulse Rate||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||bpm||Standard Deviation|Mean
1254635|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Diastolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||mm Hg||Standard Deviation|Mean
1254636|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Diastolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||mm Hg||Standard Deviation|Mean
1254637|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Systolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||mm Hg||Standard Deviation|Mean
1254638|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Systolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||mm Hg||Standard Deviation|Mean
1254639|NCT00472199|Secondary|Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation|"Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation).~Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline."|after at least 1 week of treatment discontinuation|Treated Set, all patients who were documented to have taken at least one dose of study medication|||participants|||Number
1254640|NCT00472199|Secondary|Diagnosis of Classified Augmentation According to Independent Expert Panel|Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment.|after at least 4 weeks of treatment|Treated Set and where patients received study medication for at least 4 weeks (Treated Set includes all patients who were documented to have taken at least one dose of of treatment)|||participants|||Number
1254641|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254642|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254643|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Vitality After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better vitality|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254645|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254646|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254647|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better physical functioning|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254648|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better mental health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254649|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension General Health After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health status|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254650|NCT00472199|Secondary|Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less bodily pain|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254651|NCT00472199|Secondary|Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks|RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254652|NCT00472199|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks|The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254653|NCT00472199|Secondary|Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks|Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||scores on a scale||Inter-Quartile Range|Median
1254654|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Tired or Sleepy During the Day After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254655|NCT00472199|Secondary|"Change From Baseline RLS-6 Score Severity During the Day Engaged in Activities After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254656|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity During the Day When at Rest After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254657|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity During the Night After 26 Weeks"|The question was rated on an 11-point Likert scale, ranging from “none/not at all” (0) to “very severe” (10), to reflect the patient’s condition during the previous week|baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254658|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity Falling Asleep After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254685|NCT00471705|Primary|Failure|At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment|Until 3 months posttreatment||||participants|||Number
1254659|NCT00472199|Secondary|"Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score Satisfaction With Sleep After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
1254660|NCT00472199|Secondary|Patient Global Impression (PGI) Responder Rate|PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||participants|||Number
1254661|NCT00472199|Secondary|International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate|IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||participants|||Number
1254662|NCT00472199|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Responder Rate|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values.|||participants|||Number
1254663|NCT00472199|Primary|Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks|IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Standard Error|Least Squares Mean
1254664|NCT00472082|Secondary|Safety, Including Incidence of Post- Transplant Infections, Malignancies, Morbidities, Hypertension, Glucose Intolerance, Serum Cholesterol and Triglycerides Profile Over Time, Development of New Anti-donor Antibodies.||1 year|||||||
1254665|NCT00472082|Primary|Efficacy Will be Determined by Change in Renal Function as Measured by Cold Iothalamate Glomerular Filtration Rate(GFR)3 Months After Enrollment, and Acute Rejection Episodes Within the First 6 Months Post Enrollment.||6 months from conversion|||||||
1254666|NCT00472056|Primary|Disease-free Survival (DFS)|DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.|Up to 5 years from transplant date.|Analysis was per protocol.|||months||Full Range|Mean
1254667|NCT00472030|Secondary|Change in Histamine Release Assay Following Treatment With Omalizumab.|The histamine release assay measures the release of histamine which occurs upon stimulation of basophilic granulocytes depending upon their sensitivity to an allergen.|Up to 24 weeks|We were unable to complete this assay in our research subjects due to technical difficulties.||||||
1254668|NCT00472030|Secondary|Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16||Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||units per milliliter|||Number
1254669|NCT00472030|Primary|Median Increase in Prednisone Dosage Measured at Week 4, 8 and 24 in Patients Treated With Omalizumab and in Patients Receiving Standard Therapy.|The total dose of prednisone required to control the bullous pemphigoid at week 4, 8 and 24 weeks was to be calculated in both arms of this study.|Week 4, Week 8 and Week 24|Neither subject required treatment with Prednisone. Since we did not enroll any subject in the Prednisone Standard Therapy Treatment Arm we do not have any measurements for this outcome||||||
1254670|NCT00472030|Primary|Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24.|Measurement of total body surface area affected by bullous pemphigoid active skin disease(active erosions, blisters, and/or lesions) was measured at Day 0 (prior to treatment with Omalizumab) and at 24 weeks (24 weeks is end of study).|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||percentage of active skin disease|||Number
1254671|NCT00472030|Secondary|Decrease in Eosinophil Levels Following Treatment With Omalizumab.|The subject's eosinophil count measured at baseline was compared to the eosinophil count at week 8. A normal eosinophil count at the University of Iowa Hospital lab is 0-0.4 cells per microliter|Baseline, 24 weeks.|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||cells/microliter|||Number
1254672|NCT00472030|Secondary|Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab.|Anti-BP180 IgG levels were completed using an Elisa assay. Anti-BP180 IgG levels were obtained prior to baseline and at week 16|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||units per milliliter|||Number
1254686|NCT00471705|Secondary|Recurrence|Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.|Until 6 months post-treatment||||Participants|||Number
1257483|NCT00452335|Secondary|Abdominal Bloating|Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1254673|NCT00472030|Primary|Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters.|The study subject underwent physical examination and was assessed for cessation of new blister formation via physical examination and photography.|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||weeks|||Number
1254674|NCT00471822|Secondary|Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors|Participants for carriage of streptococcus pneumoniae were analyzed with respect to various risk factors which included number of bathrooms, number of siblings in the family (multiple siblings), size of the house in meter square (house area), frequency of hand wash in a day, bed sharing, smoking by family member, child breast feeding (breast milk practice), daycare attendance, vaccination for flu and pneumococcus, history of otitis media and upper respiratory infection (URI), antibiotic use and influenza virus infection.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. 'n' signifies those participants who were evaluated for the respective risk factor.|||Percentage of Participants|||Number
1254675|NCT00471822|Secondary|Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril|Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.|Day 1|Evaluable population included all participants who met inclusion and exclusion criteria for the study.|||Percentage of Participants|||Number
1254676|NCT00471822|Secondary|Antibiotic-Resistant Streptococcus Pneumoniae Strains|Antibiotic resistance is defined as in vitro inhibition of a particular bacterial strain by a concentration of the drug associated with high likelihood of therapeutic failure. Antibiotic resistance for streptococcus pneumoniae was assessed against Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole. The standard breakpoint value (microbial growth inhibition zone) for Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole was not more than 8, 4, 13, 15 and 15 millimeter (mm) respectively. Percentage of participants with antibiotic-resistant streptococcus pneumoniae strains are reported. The same participant may have streptococcus pneumoniae strains which is resistance to more than one antibiotic.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, ‘N’ (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.|||Percentage of Carrier Participants|||Number
1254677|NCT00471822|Secondary|Serotype Distribution of Streptococcus Pneumoniae Isolates|Streptococcus pneumoniae in swab culture of nasopharynx were serotyped. The assessment included 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F, non-vaccine, non-typable and missing serotypes. Percentage of participants under different vaccine serotypes in identified isolates of streptococcus pneumonia are reported.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, ‘N’ (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.|||Percentage of Carrier Participants|||Number
1254678|NCT00471822|Primary|Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx|Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study.|||Percentage of Participants|||Number
1254679|NCT00471718|Primary|Number of Patients Who Demonstrated Treatment Effectiveness Based on Prostate Specific Antigen (PSA) Response in Non-measurable Disease|Patients with a minimum 50% decline in PSA from pre-treatment baseline, confirmed by a second PSA 4 or more weeks later, measured in nanograms per milliliter of blood.|after four weeks|Men with non-measurable disease: all other lesions, bone lesions, leptomeningeal disease, cystic lesions, abdominal masses that are not followed by imaging techniques|||participants|||Number
1254680|NCT00471718|Secondary|Safety Profile Based on Number of Patients With Worst Grade Toxicities|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening or disabling, grade 5 = death)following NCI Common Toxicity Criteria|at 30 days after final treatment dose||||patients|||Number
1254681|NCT00471718|Secondary|Overall Survival|Number of weeks from the date the patient started study drug to the date of the patient's death.|date on study to date of death from any cause|At the time of this analysis, all 27 patients were deceased due to progressive prostate cancer.|||Weeks||95% Confidence Interval|Median
1254682|NCT00471718|Secondary|Median Time to Tumor Progression|"Number of weeks from the date the patient started study drug to the date of the patient's tumor progression documented radiographically or by PSA testing.~Tumor progression is measured at baseline and after two 28-day cycles"|date on study to date of progression|Patients who received treatment and who were available for measurement of tumor or who available for PSA testing|||Weeks||95% Confidence Interval|Median
1254683|NCT00471718|Secondary|Number of Patients With Objective Response (CR & PR) by RECIST|Number of participants in each best tumor response category, RECIST criteria (v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in sum longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in sum LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of smallest sum of the LD of target lesions.|after four weeks|Participants with measurable disease who completed at least one cycle of treatment with tumor assessment.|||participants|||Number
1254684|NCT00471718|Primary|Maximum Tolerated Dose (MTD)|MTD is determined by the 3+3 study design, in which patients are enrolled in cohorts of 3. In any dose cohort, if 1 patient of 3 experience dose-limiting toxicity (DLT), three additional patients will be enrolled at the same dose level. Whenever >=2 of 6 subjects experience a DLT, then the maximum tolerated dose (MTD) has been exceeded. The MTD is generally one dose below that at which DLT occurs in >= 2 of 6 subjects in any given cohort.|up to four weeks|Phase I patients who received treatment|||mg twice a day|||Number
1292330|NCT00106938|Secondary|Freedom From Mortality||0 to 730 days||||percentage of participants|||Number
1254687|NCT00471705|Primary|Complete Clinical Response|"Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment.~Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment."|Until 6 months posttreatment|The efficacy of the treatments was calculated by intention to treat and by protocol.|||participants|||Number
1254688|NCT00471536|Secondary|Survival Time|The distribution of survival times will be estimated using the Kaplan-Meier method.|Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registration|all participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
1254689|NCT00471536|Secondary|Time to Disease Progression|The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.|Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration|All participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
1254690|NCT00471536|Secondary|Duration of Response|The distribution of response durations will be estimated using the Kaplan-Meier method.|From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 year|There were no responses.||||||
1254691|NCT00471536|Secondary|Confirmed Tumor Response (CR and PR)|Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.|Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed up to 1 year||||participants|||Number
1254692|NCT00471536|Secondary|Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.|Every 4 weeks during treatment (maximum duration was 44 weeks)|Eighteen of the 19 participants accrued to the study were evaluable for adverse events.|||participants|||Number
1254693|NCT00471536|Primary|Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])|"Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria:~A Complete Response (CR) requires the disappearance of all target lesions.~A Partial Response (PR) requires >=30% decrease in the sum of the longest diameter of target lesions from baseline measurement.~All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response."|Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.|All participants meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluated for response.|||participants|||Number
1254694|NCT00471497|Secondary|Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months||Baseline, 12 months|||||||
1254695|NCT00471497|Secondary|Rate Reduction in BCR-ABL Transcript Levels in Nilotinib Treatment Arms With Imatinib at 12 Months||Baseline, 12 months|||||||
1254696|NCT00471497|Secondary|Rate of Durable MMR at 24 Months.||Baseline, 24 months|||||||
1254697|NCT00471497|Primary|Molecular Response Rate (MMR) at 12 Months|Rate of MMR is defined as <= 0.1% BCR-ABL/ABL ratio by international scale (IS), measured by real-time quantitative polymerase chain reaction (RQ-PCR) which corresponds to a ≥ 3 log reduction of BCR-ABL transcript from standardized baseline. BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson protooncogene)|Baseline, 12 months|Patients in the Full Analysis Set (FAS) were analyzed according to the treatment they were randomized to regardless of actual treatment received.|||Percentage of participants||95% Confidence Interval|Number
1254698|NCT00471445|Primary|Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo|"Cancer survivors who completed chemotherapy at least 1 month prior and had Chemotherapy Induced Peripheral Neuropathy (CIPN) (greater than or equal to 4 out of 10) were enrolled. CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average pain, numbness, or tingling in their hands and feet over the past 24 hours on an 11-point numeric rating scale at baseline and 6 weeks post intervention. CIPN ranges from 0 (no pain) to 10 (worst possible pain)."|Week 6 - Baseline||||units on a scale||95% Confidence Interval|Mean
1254699|NCT00471380|Primary|Intra Ocular Pressure (IOP)|Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points|Baseline, end of each period (week 8, week 16, week 24)||||mm Hg (millimeters mercury)*week||Standard Deviation|Mean
1254700|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1254701|NCT00471354|Secondary|CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1254702|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1257556|NCT00450983|Secondary|Expression of NKG2 Ligands of Leukemic Blasts||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
1254703|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1254704|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores|Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1254705|NCT00471354|Secondary|Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes|Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).|||Spearman Correlation Coefficient|||Number
1254706|NCT00471354|Primary|Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)|Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).|||Spearman Correlation Coefficient|||Number
1254707|NCT00471328|Secondary|Overall Clinical Benefit (Complete Response [CR]/Partial Response [PR] or Stable Disease [SD]) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|The overall clinical benefit includes the best overall responses of CR, PR, or SD. The best overall responses of CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. The best overall response of SD must have at least one SD (or better) at least 6 weeks (or 6 months or 12 months as applicable) after randomization but before progression.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.|||Percentage of Participants||95% Confidence Interval|Number
1254708|NCT00471328|Secondary|Overall Clinical Benefit (Complete Response [CR]/Partial Response [PR] or Stable Disease [SD]) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)|The overall clinical benefit includes the best overall responses of CR, PR, or SD. The best overall responses of CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. The best overall response of SD must have at least one SD (or better) at least 6 weeks (or 6 months or 12 months as applicable) after randomization but before progression.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.|||Percentage of Participants||95% Confidence Interval|Number
1254709|NCT00471328|Secondary|Number of Responders With Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|The best overall response (CR/PR) must be confirmed by at least two determinations at least 4 weeks apart before progression. Using modified RECIST criteria, a Complete Response is defined as disappearance of all lesions, and a Partial Response is defined as either 1) at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions or progression of non-target lesions or 2) disappearance of all target lesions but persistence of one or more non-target lesion(s).|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.|||Participants|||Number
1254710|NCT00471328|Secondary|Number of Responders With Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) From Central Radiology Review During Primary Analysis (Data Cut-off: June, 2008)|The best overall response is the best response recorded from randomization until disease progression. The CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. Using modified RECIST criteria, a Complete Response is defined as disappearance of all lesions, and a Partial Response is defined as either 1) at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions or progression of non-target lesions or 2) disappearance of all target lesions but persistence of one or more non-target lesion(s).|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.|||Participants|||Number
1254795|NCT00470834|Secondary|Number of Participants With Metastatic Disease|Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.|Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)|ITT Population|||participants|||Number
1257557|NCT00450983|Secondary|Reconstitution of NK Function According to Time After HSCT||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
1254711|NCT00471328|Primary|Progression-free Survival (PFS) From Local Investigator’s Assessment Based on Treatment Crossover Analysis Set|PFS is defined as the time from the first date of cross-over to nilotinib therapy from the control arm to the date of the first observation of documented disease progression. Tumor assessment was based on the local investigator's measurement using Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.|||days||95% Confidence Interval|Median
1254712|NCT00471328|Secondary|Overall Survival for Treatment Crossover Analysis Set|For patients who crossed-over to nilotinib from the control arm, the overall survival was the time from the first dose date of nilotinib after switching from control arm to the date of death due to any cause. If death was not observed, the OS was censored at the latest date the patient was known to be alive.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.|||days||95% Confidence Interval|Median
1254713|NCT00471328|Secondary|Overall Survival During Core and Extension Phases of the Study|Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, survival will be censored at the date of last contact. This analysis included both Core and Extension data as well as survival follow up data.|Up to 50 months (including core, extension and follow up period)|Core Full Analysis Set (Core FAS): included all randomized patients included in the Core study. Analyses based on Core FAS does not account for treatment crossover i.e.pooling all data both before and after crossover. This analysis set was used to conduct an overall survival analysis.|||days||95% Confidence Interval|Median
1254714|NCT00471328|Secondary|Overall Survival Based on Primary Analysis (Data Cut-off:June, 2008)|Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, survival will be censored at the date of last contact.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized participants and was used as the primary efficacy population.|||days||95% Confidence Interval|Median
1254715|NCT00471328|Primary|Progression-free Survival (PFS) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.|||days||95% Confidence Interval|Median
1254716|NCT00471315|Primary|The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.|The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.|3 months||||units on a scale||Standard Deviation|Mean
1254717|NCT00471315|Secondary|Toleration of the Medication as Measured by the Duloxetine Compliance Rate|The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.|3 Months||||participants|||Number
1254718|NCT00471276|Other Pre-specified|1-Year Survival Probability|Probability of survival 1 year after the first dose of study treatment.|Baseline up to 1 year|ITT|||Percentage of participants||95% Confidence Interval|Number
1254719|NCT00471276|Secondary|Change From Baseline in CTSQ Score: Satisfaction With Therapy|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.|||Units on a scale||Full Range|Median
1254720|NCT00471276|Secondary|Change From Baseline in CTSQ Score: Feelings About Side Effects|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.|||Units on a scale||Full Range|Median
1254721|NCT00471276|Secondary|Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.|||Units on a scale||Full Range|Median
1254722|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254723|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254724|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254725|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254726|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254727|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254728|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254766|NCT00471146|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.|Baseline until death or at least 1 year after the randomization of last participant|DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).|||Weeks||95% Confidence Interval|Median
1254729|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254730|NCT00471276|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
1254731|NCT00471276|Secondary|Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy|Number of participants with objective response based assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Week 9, and every 8 weeks up to Month 34|ITT; N=participants who received at least 2 lines of prior chemotherapy for advanced/metastatic disease and had post baseline tumor assessment|||Participants|||Number
1254732|NCT00471276|Secondary|Overall Survival (OS)|Time from randomization to date of death due to any cause. OS (Months)=(death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.|Baseline until death (up to Month 34)|ITT|||Months||95% Confidence Interval|Median
1254733|NCT00471276|Secondary|Duration of Response (DR)|Time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or death due to any cause, whichever occurred first. DR calculated as (Weeks)=(end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.|Baseline up to Month 34 or early termination|ITT; N=participants with objective response|||Weeks||Full Range|Median
1254734|NCT00471276|Secondary|Progression-Free Survival (PFS)|Time from date of randomization to date of first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months)=(first event date minus randomization date plus 1) divided by 30.4.|Baseline up to Month 34|ITT|||Months||95% Confidence Interval|Median
1254735|NCT00471276|Secondary|Number of Participants With Objective Response of Superficial Lesions|Number of participants with objective response based assessment of confirmed CR or PR of superficial lesions according to RECIST. Superficial lesions included skin lesions, chest wall lesions, and breast lesions and lymph nodes if followed up by physical examination.|Baseline, every 4 weeks up to Month 34|ITT; Number of participants analyzed equaled (N =) participants who had superficial lesions with post baseline follow-up assessments of those lesions.|||Participants|||Number
1254736|NCT00471276|Secondary|Number of Participants With Clinical Benefit|The sum of participants with confirmed CR, PR, and stable disease (SD) greater than (>) 6 months according to RECIST. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum of longest dimensions since treatment started.|Baseline, Week 9, and every 8 weeks up to Month 34|ITT|||Participants|||Number
1254737|NCT00471276|Primary|Number of Participants With Objective Response|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Week 9, and every 8 weeks up to Month 34|Intent to Treat (ITT) population: all enrolled participants|||Participants|||Number
1254738|NCT00471237|Secondary|Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic parameters population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
1254739|NCT00471237|Secondary|Maximum Blood Concentration (Cmax) of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, Cmax of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic parameter population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1254806|NCT00470548|Secondary|Number of Participants With Disease Control|Disease control is complete response plus partial response plus stable disease from the start of treatment to death or disease progression.|Up to 2 years||||Participants|||Count of Participants
1254740|NCT00471237|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, AUC(0-t) and AUC(0-τ) of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic Parameters Population comprised of any participant in the pharmacokinetic concentration population who provided pharmacokinetic parameters. Only those participants available at the specified time points were analyzed.|||nanogram*hour per millilitre (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1254741|NCT00471237|Secondary|Blood Concentrations of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Blood concentrations of ronacaleret were reported.|Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic Concentration Population comprised of any Intent-to-Treat participants for whom a SB-751689 pharmacokinetic blood sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.|||nanograms per millilitre (ng/mL)||Standard Deviation|Mean
1254742|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of BALP.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||mcg/L||Standard Error|Least Squares Mean
1254743|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of P1NP.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent to treat population. Only those participants available at the specified time points were analyzed.|||Microgram per Litre (mcg/L)||Standard Error|Least Squares Mean
1254744|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of CTX1.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||nanogram per litre (ng/L)||Standard Error|Least Squares Mean
1254745|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans|Percent change in thickness of femur neck cortical VOI thickness and trochanter cortical VOI thickness were at Month 12 measured by QCT were reported. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Percent change in cortical thickness||Standard Deviation|Mean
1254746|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in mg/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Percent change in BMD||Standard Deviation|Mean
1254747|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Percent change in VOI||Standard Deviation|Mean
1254748|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular volume of interest (VOI) are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline to month 12 in the volumetric integral, cortical, and trabecular density (BMD) at the hip and lumbar spine measured by QCT were reported.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Percent change in BMD||Standard Deviation|Mean
1254749|NCT00471237|Secondary|Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)|Responder rate of participants who remained the same or had any improvement as compared to baseline in DXA BMD of vertebra, femur and vertebra plus femur were reported. Baseline values were assessed on Day 0. Percent change (improvement) from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0), Month 5, 6 and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1254750|NCT00471237|Secondary|Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 and 12 in aBMD of hip (total hip, femoral neck and trochanter) were reported.|Baseline (Day 0), Month 6 and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented.|||Percent change in BMD||Standard Error|Least Squares Mean
1254751|NCT00471237|Secondary|Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 in aBMD was reported.|Baseline (Day 0) and Month 6|Intent to Treat Population. Only those participants available at the specified time point were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented.|||percent change in BMD||Standard Error|Least Squares Mean
1254752|NCT00471237|Primary|Mean Change From Baseline in Weight|Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported.|Baseline (Day 0), Month 6, 12 and early withdrawal|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Kilogram||Standard Deviation|Mean
1254753|NCT00471237|Primary|Mean Change From Baseline in Height|Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported.|Baseline (Day 0), Month 6, 12 and early withdrawal|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Centimeter||Standard Deviation|Mean
1254754|NCT00471237|Primary|Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event|Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett’s correction) interval, QTcF (Fridericia’s correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study.|Up to 12 months|Intent-to-Treat population.|||Participants|||Count of Participants
1254755|NCT00471237|Primary|Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit|The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (> 30 millimeter of mercury [mmHg] decrease from Baseline, > 30 mmHg increase from Baseline), diastolic blood pressure (> 20 mmHg decrease from Baseline and > 20 mmHg increase from Baseline) and heart rate (<45 and >120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 12 Months|Intent-to-Treat population.|||Participants|||Count of Participants
1254756|NCT00471237|Primary|Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit|The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported.|Up to Month 12|Intent-to-Treat population.|||Participants|||Count of Participants
1254757|NCT00471237|Primary|Number of Participants Withdrew Due to Hypercalcemia|A confirmed albumin-adjusted serum calcium pre-dose value of >11.0 mg/dL or post-dose value of >12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported.|Up to Month 12|Intent-to-Treat population.|||Participants|||Count of Participants
1254758|NCT00471237|Primary|Number of Participants With Hypercalcemia|Participants with albumin-adjusted serum calcium pre-dose values of >11.0 mg/ deciliter (dL) or post-dose values of >12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported.|Up to Month 12|Intent-to-Treat population.|||Participants|||Count of Participants
1254778|NCT00471081|Secondary|Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|At Month 1 (GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||μg/mL||95% Confidence Interval|Geometric Mean
1254807|NCT00470548|Secondary|Number of Participants With Partial Response|At least a 30% decrease in the sum of the longest diameter of target lesions|Up to 2 years||||Participants|||Count of Participants
1292331|NCT00106938|Secondary|Freedom From Mortality||0 to 365 days||||percentage of participants|||Number
1254759|NCT00471237|Primary|Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported.|Baseline (Day 0) and 12 Months|Intent-to-Treat population comprised of any randomised or teriparatide participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed. Teriparatide arm was excluded from the analysis, since these participants were not randomized and were disproportionately represented.|||Percent change in BMD||Standard Error|Least Squares Mean
1254760|NCT00471146|Secondary|Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months|||||||
1254761|NCT00471146|Secondary|Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Millimeter (mm)||Standard Deviation|Mean
1254762|NCT00471146|Secondary|Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
1254763|NCT00471146|Secondary|Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
1254764|NCT00471146|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score|QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from ‘1=not at all’ to 4=’very much’ and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
1254765|NCT00471146|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
1254793|NCT00470847|Secondary|Progression Free Survival|Progression Free Survival is the time from date of start of treatment to the date of the first documented progression or death due to any cause. If a patient has not progressed or died, progression free survival is censored at the time of last tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years||||months||Full Range|Median
1254767|NCT00471146|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, every 8 weeks until tumor progression or death|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1254768|NCT00471146|Secondary|Progression Free Survival (PFS)|"Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until disease progression or at least 1 year after the randomization of last participant|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
1254769|NCT00471146|Primary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or at least 1 year after the randomization of last participant|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
1254770|NCT00471107|Primary|Verbal Memory|The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled).|24 hours|All subjects in this group for whom data were obtained were analyzed|||Words recalled||Standard Deviation|Mean
1254771|NCT00471081|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.|Up to study end (Month 9)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1254772|NCT00471081|Secondary|Number of Subjects Reporting Rash|Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.|Up to study end (Month 9)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1254773|NCT00471081|Secondary|Number of Subjects With New Onset Chronic Ilnesses (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Up to study end (Month 9)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1254774|NCT00471081|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to study end (Month 9)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1254775|NCT00471081|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Up to 1 month post-vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1254776|NCT00471081|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in and for whom data were available. Post-Dose 2 data are not available for the GSK 134612 1 dose Group (received a single vaccination).|||Participants|||Count of Participants
1254777|NCT00471081|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in and for whom data were available. Post-Dose 2 data are not available for the GSK 134612 1 dose Group (received a single vaccination).|||Participants|||Count of Participants
1293195|NCT00100698|Secondary|Change in Extremity Fat|Change in extremity fat|18 months||||kilograms||Standard Error|Mean
1254779|NCT00471081|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).|At Month 1 (GSK 134612 s doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
1254780|NCT00471081|Secondary|Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).|At Month 1 (GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
1254781|NCT00471081|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 1 (GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Titers||95% Confidence Interval|Geometric Mean
1254782|NCT00471081|Secondary|Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.|At Month 1 (GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
1254783|NCT00471081|Secondary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.|At Month 1 (for GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
1254784|NCT00471081|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 1 (for GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Titers||95% Confidence Interval|Geometric Mean
1254785|NCT00471081|Secondary|Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|At Month 1 (for GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
1254786|NCT00471081|Secondary|Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|One month after the first dose (at Month 1)|This analysis was performed on subjects who have received the Month 0 vaccination in the GSK 134612 2 doses Group from the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1254787|NCT00471081|Primary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|One month after the last dose (at Month 4)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1254788|NCT00471068|Primary|Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment|IOP measured at week 6 minus IOP measured at baseline|At week 0 and week 6||||millimeters mercury (mm Hg)||Standard Deviation|Mean
1254789|NCT00470847|Secondary|Overall Survival|Overall average length of participant survival after protocol initiation|Participants were followed for an average of 3.8 years||||Months||Full Range|Median
1254790|NCT00470847|Secondary|Percentage of Participants Having Non-Central Nervous System Sites as the Site of First Progression||5 years||||percentage of participants|||Number
1254791|NCT00470847|Secondary|Percentage of Participants Having Central Nervous System as the Site of the First Progression||5 years||||percentage of participants|||Number
1254792|NCT00470847|Secondary|Objective Response Rate in Central Nervous System Sites|Objective Response Rate was defined using volumetric response as the following: Complete Response (CR) is the disappearance of all target lesions, stable/responsive non-target lesions, and no new lesions. Partial response (PR) is at least a 50% reduction in the sum of the target lesions, stable/responsive non-target lesions, and no new lesions. Stable Disease (SD) is neither CR PR or Progressive Disease (PD). And Progressive Disease (PD) is at least 40% increase in sum of target lesionsor the appearance of any new lesion >=6mm in the longest dimension. If a patient progressed in a non-central nervous system(CNS) site first, died, or withdrew from the study for any reason after the first dose of drug was administered, and before a CR or PR in the central nervous system was determined, she was considered a CNS non-responder.|5 years|28 participants had measurable disease out of the 35 participants enrolled.|||percentage of participants||95% Confidence Interval|Number
1254796|NCT00470834|Secondary|Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42|Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 6, 12, 18, 21, and 42|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Nanograms per milliliter (ng/mL)||Full Range|Median
1254797|NCT00470834|Secondary|Number of Participants With PSA Response|PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.|Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)|ITT Population|||participants|||Number
1254798|NCT00470834|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.|Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)|ITT Population. Data were not summarized for censored participants (no treatment failure).|||Days||Standard Deviation|Mean
1254799|NCT00470834|Primary|Time to Disease Progression|Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.|Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)|Intent-to-Treat (ITT) Population: all participants randomized to study treatment. Data were not summarized for censored participants (no disease progression).|||Days||Standard Deviation|Mean
1254800|NCT00470626|Secondary|Mean Time to Retrieval Attempt|"Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made.~A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made."|up to 12 months||||days||Standard Deviation|Mean
1254801|NCT00470626|Secondary|Successful Retrieval|Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device).|up to 12 months|129 patients received a filter. Filters were placed as permanent devices in 34 patients and as temporary devices in 95 patients. A decision to retrieve a filter was made by the physician once the patient’s medical condition warranted it (once the fliter was no longer required). Filter retrieval was attempted in 58 of 95 patients.|||successful retrievals|||Number
1254802|NCT00470626|Primary|Major Adverse Event|Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.|up to 12 months||||participants|||Number
1254803|NCT00470600|Secondary|Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).|Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.|Study hour-6 to hour-28|Demand of narcotic use was determined by PCA records or by chart if patient requested and not via PCA.|||milligrams||Standard Deviation|Mean
1254804|NCT00470600|Secondary|Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)|"Measurement of the patient’s self assessment of pain at rest using a visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from No pain (0 mm) to Worst possible pain (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint)."|Study hour-6 through hour-28|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.|||AUC-VAS pain v. time (mm*hr)||Standard Error|Least Squares Mean
1254805|NCT00470600|Primary|AUC-VAS With Movement (Post-operative Period, Hour-6-28)|"Measurement of the patient’s self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from No pain (0 mm) to Worst possible pain (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery [variable since every surgery has a unique length of time even if it is the same procedure] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint)."|Study hour-6 through hour-28|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.|||AUC-VAS pain v. time (mm*hr)||Standard Error|Least Squares Mean
1288230|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36||Month 36||||L||Standard Error|Mean
1254808|NCT00470548|Secondary|Number of Participants With Stable Disease|Stable Disease is measured from the start of the treatment until the criteria for disease progression are met. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years||||Participants|||Count of Participants
1254809|NCT00470548|Secondary|Number of Participants With Complete Response|Per RECIST criteria, complete response (CR) is defined as the disappearance of all target lesions.|Up to 2 years||||participants|||Number
1254810|NCT00470548|Secondary|Duration of Overall Survival|From time of enrollment to the first observation of disease progression or death.|Up to 2 years|Of the 12 patients in the phase I component 10 were assessable for response. In the phase II component, 31 of 37 patients were evaluable for response.|||months||Standard Error|Median
1254811|NCT00470548|Primary|Number of Patients With Toxicities|Toxicities was evaluated based on the standard NCI CTCAE Version 3.0 grading criteria. Attributable grade ≥ 3 hematologic and non-hematologic toxicities are presented here.|Up to 1 year||||Participants|||Count of Participants
1254812|NCT00470548|Primary|Number of Participants With Dose Limiting Toxicities|Dose limiting toxicity (DLT) was defined as any of the following occurring during the first cycle: Grade 4 thrombocytopenia, or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion, febrile neutropenia, neutropenia with documented infection. Non-hematologic DLT included any other ≥ grade 3 non-hematologic toxicity that was clinically significant and considered by the investigator to be related to study drug. Alopecia and grade 3 allergic reaction/hypersensitivity with infusion were not considered DLTs.|Up to21 days|At dose level 1, 2 and 3 three participants were treated with no dose limiting toxicities. Three additional participants were treated at dose level 3 with no dose limiting toxicities.|||participants|||Number
1254813|NCT00470535|Secondary|Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade||At Baseline|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
1254814|NCT00470535|Secondary|Correlation of Smoking Status With Overall Survival||Every 3 weeks|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
1254815|NCT00470535|Secondary|Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy||Every 3 weeks|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
1254816|NCT00470535|Secondary|Median Overall Survival||After every cycle|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
1254817|NCT00470535|Secondary|Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria||After every cycle|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
1254818|NCT00470535|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion|Every cycle for up to 52 weeks|All treated and eligible patients|||months||95% Confidence Interval|Median
1254819|NCT00470470|Secondary|Time to Progression|Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. Time to progression will be estimated using the Kaplan-Meier method.|Time from the treatment start to the date of disease progression||||weeks||Inter-Quartile Range|Mean
1254820|NCT00470470|Primary|Objective Response Rate|Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon two-stage minimax design will be employed.|Every 6 weeks for the first 3 courses and then every 12 weeks thereafter||||participants|||Number
1254821|NCT00470418|Secondary|Changes From Baseline in Clinical Measures of Cognition at Terminal Visit|Mini-Mental Status Exam (MMSE) 0(worst)-30(best); ADAS-cog 0 (best cognitive performance across multiple domains) - 70(worst); Activities of Daily Living (ADCS-ADL) 0(least capable of function in daily and instrumental activities)-54(best)|baseline and six weeks||||units on a scale||Standard Deviation|Mean
1254822|NCT00470418|Primary|Safety Assessments: Number of Participants With Adverse Events|vital signs, physical exam, Symptom Checklist, complete blood count, serum chemistries, urinalysis, and electrocardiogram|Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks||||Participants|||Count of Participants
1254823|NCT00470392|Secondary|Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2|Based upon upregulated mRNA expression of MyxA in 1 out of 7 patients treated with Imiquimod, a list of alternative target genes responsive to Imiquimod was generated. The target mRNAs examined included GRAMD1A, IL2RA, TGHD1, DMXL2. The target gene was consider upregulated if there was a 1.5 fold increase in the mRNA expression of the target gene.|Biopsy samples for analysis were taken 1 hour post UVB treatment||||participants|||Number
1254824|NCT00470392|Secondary|Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment|The PASI is a disease burden measure that integrates area, erythema, thickness and scale of each target lesion. The severity score for each region is calculated by adding the scores for redness, thickness and scale (each of which are graded from 0 to 4). The maximum severity score is 12. The higher the PASI, the worse the disease. Thus, an improvement in PASI score is a lower score than the pre-treatment PASI.|2 weeks after Imiquimod and UVB|Per protocol.|||participants|||Number
1254825|NCT00470392|Primary|Number of Subjects With Elevated MyxA|Lesions were treated with either Imiquimod or Clobetasol cream. Lesions were subsequently treated with UVB and biopsied. From the biopsy samples obtained from the Imiquimod arm, quantitative PCR was performed to measure levels of Myx A, an imiquimod response gene.|Biopsy samples for analysis were taken 1 hour post UVB treatment|Per protocol.|||participants|||Number
1288231|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36||Month 36||||L||Standard Error|Mean
1254827|NCT00470366|Secondary|Percentage of Participants With Progression Free Survival|Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years||||percentage of patients||95% Confidence Interval|Number
1254828|NCT00470366|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 8 years||||years||Full Range|Median
1254829|NCT00470366|Primary|Rate of Complete Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|3 years||||Participants|||Count of Participants
1254830|NCT00470301|Primary|Pathologic Complete Response Rate (pCR) Evaluated Using RECIST (Phase II)|An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising.|Up to 5 years||||participants||95% Confidence Interval|Number
1254831|NCT00470301|Primary|Recommended Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I)||2 weeks|||||||
1254832|NCT00470275|Primary|Response|Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.|the first six cycles of study chemotherapy (126 days)||||participants|||Number
1254833|NCT00470262|Secondary|IMCL|Intramyocellular lipid was measured using immunohistochemistry (using oil Red O staining) in muscle biopsy specimens. Oil red O-stained muscle sections were magnified with an Olympus Provis (Tokyo, Japan) light microscope, and images were digitally captured by using a connected charge-coupled device camera (Sony, Tokyo, Japan). Fiber-typed and oil red O-stained fibers were matched. The oil red O staining intensity of either type 1 or 2 muscle fibers was quantified using National Institutes of Health Image program (http://rsb.info.nih.gov/nih-image/). By adjusting a density threshold, the software was set to recognize the presence of one fat droplet only if its highlighted surface was exceeding 0.40 μm2 or larger. Muscle lipid content was calculated by total area of lipid droplets in a given muscle fiber divided by the total area of the same fiber. The mean number of fibers analyzed per sample was 40 for type 1 and 2 muscle fibers|3 months||||% of lipid area stained||Standard Deviation|Mean
1254834|NCT00470262|Primary|Insulin Sensitivity|Insulin sensitivity was measure through frequently sampled intravenous glucose tolerance test. Subjects presented to research center fasting. Blood samples were collected at -21, -11, and -1 minutes. At time t=0 initiates the start of the IVGTT and the injection of glucose into the non-sampling arm. The glucose dose was calculated as 11.4g/m2 of body surface area, given as a 50% dextrose solution. This glucose injection was administered over 60 seconds or less. At time t=20 minutes, an insulin dose of 0.04u/kg was administered over 30 seconds. Blood samples were collected at times t=2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140, 160, and 180. If blood sugar did not return to a steady state the test was continued to t= 210 or t= 240.|3 months||||mg*kg^-1*min^-1||Standard Deviation|Mean
1254835|NCT00470184|Secondary|Quality of Life Improved Rate||5.5 weeks|evaluable patients|||percentage of patients||95% Confidence Interval|Number
1254836|NCT00470184|Secondary|Median Time to Progression||5.5 weeks|Evaluable patients|||months||95% Confidence Interval|Number
1254837|NCT00470184|Secondary|Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1||5.5 weeks|evaluable patients|||percentage of patients||95% Confidence Interval|Number
1254838|NCT00470184|Primary|Complete Response||5.5 weeks|Evaluable Patients|||percentage of patients||95% Confidence Interval|Number
1254839|NCT00470158|Secondary|Percent Anemic||6 months|||||||
1254840|NCT00470158|Secondary|Change in Zinc Status||6 months|||||||
1254841|NCT00470158|Secondary|Change in Hemoglobin||6 months|||||||
1254842|NCT00470158|Primary|Incidence of Diarrhea|A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.|6 months||||episodes|||Number
1254843|NCT00470106|Secondary|Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).|This is a role play demonstration test that measures how well someone handles social communication in daily life. The scores reflect overall effectiveness and are the mean number scored across different social situations with a range of 0-5 with higher being better. There are no norms for this test.|Assessments at endpoint (12 weeks).||||number correct||Standard Deviation|Mean
1254844|NCT00470106|Primary|Mean Test Scores for Facial Emotion Identification.|This is a test of social cognition that measures the ability to identify the emotion shown in photos of still faces. The construct of interest is facial affect perception. It is an experimental measure and does not have norms or cut-offs. The range of accuracy scores is 0-56 with higher being better.|Assessments for end point (12 weeks).||||number of correct answers||Standard Deviation|Mean
1254845|NCT00470093|Primary|Impact of Treatment on Growth of Myeloma Cells|Percentage change in growth of in vitro myeloma cells from baseline to end of study.|Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study|Zero participants tolerated protocol therapy and the research sample blood draws were therefore not completed as planned. Because of this, the data from this outcome could not be collected.||||||
1254846|NCT00470093|Primary|Optimal Dose of Interleukin-6|Maximum tolerated dose found using a standard 3+3 dose escalation model.|Up to 5 months|This outcome cannot be evaluated as zero participants tolerated the study regimen. All participants were enrolled on the 2.5 mg arm and a maximum tolerated dose was not found.||||||
1254847|NCT00470093|Primary|Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events|Number of participants who discontinued the protocol due to adverse events.|Up to 5 months||||Participants|||Count of Participants
1254848|NCT00470093|Primary|Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.|Number of participants with partial or complete response by Bladé criteria where partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.|Up to 5 months||||Participants|||Count of Participants
1254849|NCT00470067|Primary|Response (Complete and Partial)|Response Rate|Every 28 days|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1254850|NCT00470054|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|"The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Assessed during treatment|All 44 participants who received treatment were analyzed (including ineligible participants).|||participants|||Number
1254851|NCT00470054|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 3 years)|All eligible participants were analyzed.|||weeks||95% Confidence Interval|Median
1254852|NCT00470054|Secondary|Response to Therapy|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria."|Assessed every 2 cycles (up to 3 years)|All eligible participants were analyzed.|||participants|||Number
1254853|NCT00470054|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.~Progression is defined as in the primary outcome measure."|Time from registration to progression (up to 3 years)|All eligible participants were analyzed.|||weeks||95% Confidence Interval|Median
1254854|NCT00470054|Primary|6 Week Progression Free Survival|"Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method.~Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions."|6 weeks|All eligible participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
1254855|NCT00469911|Primary|Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants|Participants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy|2 to 10 days||||correlation co-efficient|||Number
1254856|NCT00469898|Secondary|Overall Survival||On study date to death||||Months||Full Range|Median
1254857|NCT00469898|Secondary|Time to Progression|Time to progression in months|9.9 months (on study date to progression)|Patients who has progression|||Months|Participants|Full Range|Median
1254858|NCT00469898|Secondary|Number of Patients With Adverse Events|Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event|date off treatment or progression of disease, up to 18 weeks||||participants|||Number
1254859|NCT00469898|Primary|Patient Response|"Patient response to treatment:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|1.66 months (average duration, on treatment date to best response date)||||participants|||Number
1254860|NCT00469859|Primary|>80% Inhibition of FLT3 Phosphorylation in a Majority of Post-treatment Trough Time Points|FLT3 inhibition is determined in patients receiving lestaurtinib by measuring FLT3 plasma inhibitory activity (PIA). For PIA predictive modeling, a random effects linear regression model will be used to describe the relationship between PIA and Pharmacokinetic (PK) levels for each of the 5 trough plasma samples collected for each patient|Course 1 day 7, day 14, day 21, and day 28.||||participants|||Number
1254861|NCT00469859|Primary|Dose-limiting Toxicity|Number of patients with dose-limiting toxicity (DLT)|28 days||||participants|||Number
1254862|NCT00469833|Secondary|HbA1c Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Type 2 diabetic subjects had HbA1c measured before and after 2 months of basal insulin glargine treatment.|2 months||||% glycosylated hemoglobin||Standard Error|Mean
1254863|NCT00469833|Primary|Insulin Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes||||pmol/L||Standard Error|Mean
1254877|NCT00469209|Secondary|Time to Toxicity|The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.|Baseline to event occurence (assessed weekly first 30 days)|||||||
1254965|NCT00468728|Secondary|Global Cure|Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.|End of Study|The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.|||Percentage of Participants|||Number
1254864|NCT00469833|Primary|C-peptide Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes||||nmol/L||Standard Error|Mean
1254865|NCT00469833|Primary|ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes||||pmol/min||Standard Error|Mean
1254866|NCT00469612|Secondary|Refractive Error||Every 10th visit|Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.||||||
1254867|NCT00469612|Primary|Contrast Sensitivity Function||Every 5th visit|Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.||||||
1254868|NCT00469612|Primary|Visual Acuity||Every 5th visit|Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.||||||
1254869|NCT00469508|Other Pre-specified|BDI Score|Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.|From baseline to end of treatment period (week 12).|Intention to treat, LOCF|||units on a scale||Standard Deviation|Mean
1254870|NCT00469508|Other Pre-specified|VAS Score|To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.|baseline and last observation during the 12 week treatment period|Intention to treat, LOCF|||units on a scale||Standard Deviation|Mean
1254871|NCT00469508|Secondary|Retention|The number of persons who completed the medication phase of the trial (12 weeks of medication).|12 weeks|Intention to treat|||participants|||Number
1254872|NCT00469508|Primary|Clean Urine Drug Screen|Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.|From randomization to end of week 12|Intention to treat|||Clean urine drug screens|Participants|Standard Deviation|Mean
1254873|NCT00469456|Secondary|Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12|The ASHA FACS assesses & measures functional communication skills of adults with speech, language, & cognitive communication disorders. The measure, which comprises 43 items and takes approximately 20 minutes to complete, assesses functional communication in four areas: social communication; communication of basic needs; reading, writing, and number concepts; and daily planning. Total score of subdomains [Social Communication and Communication of Basic Needs] ranges from 0-196. A higher score denotes better communication.|Baseline to Week 12|The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Least Squares Mean
1254874|NCT00469456|Primary|Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12|FLCI is a standardized & validated instrument for evaluating functional communication in pts with moderate-to-severe Alzheimer's that can be used to obtain Baseline information & to track patients' capabilities thereafter. The FLCI evaluates 10 areas: greeting and naming, answering questions, writing, sign comprehension, object-to-picture matching, word reading and comprehension, following commands, pantomime, gesture, and conversation. The FLCI total score ranges from 0 to 87, a higher score denotes better functional communication, and takes approximately 30 minutes to complete.|Baseline to Week 12|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population will consist of all patients in the Safety Population who had at least one post-Baseline assessment of the primary efficacy parameter, FLCI. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Least Squares Mean
1254875|NCT00469391|Primary|Percent Excess Weight Loss (%EWL) at Week 12|Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)|3 months||||Percentage of Excess Weight Loss||Standard Deviation|Mean
1254876|NCT00469274|Primary|Evidence of Pertussis Infection in Each PEP Arm, Defined Using Clinical, Microbiologic, or Serologic Criteria.|Defined as a positive nasopharyngeal culture or PCR for B. pertussis at any time point, a two-fold rise in the anti-PT IgG titer between acute and convalescent sera, or a single acute or convalescent anti-PT IgG titer of ≥94 EU. Post hoc, a modified definition was devised because of concern that the serologic criteria used in the primary definition might actually represent acquisition of pertussis infection prior to the intervention. The modified definition of pertussis excluded an acute anti-PT IgG titer of ≥94 EU and an acute nasopharyngeal swab that was positive for B. pertussis by PCR.|In the 21 days following exposure identification||||participants|||Number
1254878|NCT00469209|Primary|Number of Patients Reaching Complete Response (CR)|Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with <5% plasma cells, <1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.|Baseline through Day 180, with assessments at Day 90 and Day 180|Analysis was per protocol.|||participants|||Number
1254879|NCT00469092|Secondary|Number of Subjects Reporting Treatment Emergent Adverse Events|Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.|Weeks 0-26|The safety analysis population consists of all subjects exposed to trial products.|||participants|||Number
1254880|NCT00469092|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|Weeks 0-26||||events|||Number
1254881|NCT00469092|Secondary|Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)|Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.|||scores on a scale||Standard Error|Mean
1254882|NCT00469092|Secondary|Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)|The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.|||participants|||Number
1254883|NCT00469092|Secondary|9-point Self-measured Plasma Glucose Profiles|Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.|||mmol/L||Standard Error|Mean
1254884|NCT00469092|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.|After 26 weeks of treatment|Intention to Treat (Last Observation Carried Forward) population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.|||percentage of total haemoglobin||Standard Deviation|Least Squares Mean
1254885|NCT00469079|Secondary|Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week.|Changes in craving and withdrawal symptoms were assessed at the time of discontinuation of usual brand cigarettes (i.e., baseline compared to week 1). Assessments were made using the Minnesota Nicotine Withdrawal Scale, which measures abstinence effects from usual brand cigarettes. Total Score: Range of scores is from 0 to 28. All items with the exclusion of craving are summed. Craving Score: Range of score is from 0 to 4. A higher score would indicate more severe withdrawal.|Baseline and 1 week|All subjects completing the intervention|||units on a scale||Standard Error|Mean
1254886|NCT00469079|Primary|Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention.|This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected at each visit to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the end of treatment and at each of the 2 follow-up visits (week 1 and 11 post-intervention). Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report (i.e., no cigarettes smoked) and confirmed by an exhaled CO of less than 8 ppm. At the follow-up visits, abstinence was also confirmed by both exhaled CO concentrations and urinary cotinine concentration (<35 ng/mL).|12 weeks|Intent to treat model.|||participants|||Number
1254887|NCT00469079|Primary|Product Use at Week 4 of Intervention|Self-reported daily use of the assigned study product. Range of scores is from 0 to about 20. Higher scores do not represent either a better or a worse outcome. Higher number of product used per day may indicate higher abuse liability of the product but may lead to a greater suppression in usual brand cigarette smoking. Lower number of product use per day may indicate lower abuse liability but may lead to lower suppression of usual brand smoking.|4 weeks|All subjects who completed intervention.|||uses per day||Standard Error|Least Squares Mean
1254888|NCT00469079|Primary|Toxicant Exposure by Products|Levels of carcinogen biomarkers (NNAL) reported as difference between baseline and week 4 scores.|Baseline, 4 weeks|All subjects who continued in the protocol were analyzed. Non-parametric Kruskal-Wallis method of analysis was used.|||ng/ml||95% Confidence Interval|Geometric Mean
1254889|NCT00468910|Other Pre-specified|Platelet Cyclooxygenase (COX) Activity as Measured by a Peroxidase-based COX Enzyme Activity Assay|Evaluate the effect of aspirin on platelet COX activity as measured by a peroxidase-based Cox enzyme activity assay.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||pg/ml||Standard Deviation|Mean
1254891|NCT00468910|Secondary|Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67|Evaluate the effect of aspirin on colonic epithelial apoptosis and cell proliferation as assessed by immunohistochemical detection of Ki-67. These were performed on samples that had been previously analyzed for 4D-ELF.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||Percentage of Total Cells||Standard Deviation|Mean
1254892|NCT00468910|Secondary|Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3|Evaluate the effect of aspirin on colonic epithelial apoptosis and cell proliferation as assessed by immunohistochemical detection of cleaved caspase 3 .These were performed on samples that had been previously analyzed for 4D-ELF.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||Percentage of Total Cells||Standard Deviation|Mean
1254893|NCT00468910|Primary|Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.|"Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. FRAC characterizes the spatial autocorrelation function of mass density distribution in tissue.~SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture"|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa|||unitless||Standard Deviation|Mean
1254894|NCT00468910|Primary|Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.|"Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. SPEC characterizes the size distribution of macromolecular complexes and other intracellular structures, with a decrease of the spectral slope implying a shift of the size distribution of intracellular structures toward smaller sizes.~Spectral markers SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture."|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||micron^-1||Standard Deviation|Mean
1254895|NCT00468858|Secondary|Vaccine Response to DEN Antibody at Post Dose 2, Month 7|Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7|at month 7, post dose 2||||% of subjects||95% Confidence Interval|Number
1254896|NCT00468858|Secondary|Vaccine Response to DEN Antibody at Post Dose 1, Month 3|"Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody~S- = seronegative subjects (antibody titer <10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer >10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination~Vaccine response defined as: For initially seronegative subjects, antibody titer >10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) >4 fold the pre-vaccination antibody titer"|at month 3, post dose 1||||% of subjects||95% Confidence Interval|Number
1254897|NCT00468858|Secondary|Percent of Subjects With Neut. Sero-response to Each DEN Serotype|Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects|Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7||||percent of subject with attribute||95% Confidence Interval|Number
1254898|NCT00468858|Secondary|Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes|Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects|Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7||||% of subjects||95% Confidence Interval|Number
1254899|NCT00468858|Secondary|GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects|Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects|at month 7 (one month post dose 2)||||titers||95% Confidence Interval|Mean
1254900|NCT00468858|Secondary|Incidence of Suspected and Laboratory Confirmed Dengue|Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period|31-day (days 0-30) post-vaccination period and after 31-day period||||dengue fever cases|||Number
1254901|NCT00468858|Primary|Safety: Occurrence of Serious Adverse Events (SAEs)|Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose|6 months + 30 day follow-up period after last vaccine dose||||Participants|||Count of Participants
1254902|NCT00468858|Primary|Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period|Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort)|Within the 31-day (days 0-30) follow-up period after each vaccine dose||||Participants|||Count of Participants
1254903|NCT00468858|Primary|Safety: Incidence of All and Grade 3 Solicited Local Symptoms|Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)|Within 21 days (days 0-20) f/up period after each vaccine dose||||number of occurances|||Number
1254904|NCT00468845|Secondary|Total Clinically Meaningful Event (CME) Score|Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254905|NCT00468845|Secondary|Incidence of Chronic Post-operative Pain|Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.|3 and 6 Months PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed. Participants reported as no chronic pain in the 3 month visit were carried over to the missing data at 6 month visit.|||Percentage of participants|||Number
1254906|NCT00468845|Other Pre-specified|Neuropathic Pain Symptom Inventory (NPSI)|Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254907|NCT00468845|Secondary|Time to Actual Discharge|Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.|Day 1 up to Day 7 PS|mITT|||Hours||Standard Error|Mean
1254908|NCT00468845|Secondary|Time to Meet Hospital Discharge Criteria|Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.|Day 1 up to Day 7 PS|mITT|||Hours||Standard Error|Mean
1254909|NCT00468845|Secondary|Quality of Life Using EuroQol (EQ-5D) Health State Profile|"Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, confined to bed). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata."|Discharge (day 3 up to day 7 PS) and day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254910|NCT00468845|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS), Day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254911|NCT00468845|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS), Day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254912|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 28 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 28 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254913|NCT00468845|Other Pre-specified|Incision Length Correlated With Worst Pain|Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.|Day 1|mITT|||Centimeter (cm)||Standard Error|Least Squares Mean
1254914|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - End of Treatment|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 1 up to Day 28 PS|Safety population|||Percentage of participants|||Number
1254915|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 14 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 14 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254916|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 7 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 7 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254917|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Discharge|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Discharge (day 3 up to day 7 PS)|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254918|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 5 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 5 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254919|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 4 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 4 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254920|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 3 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 3 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254921|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 2 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 2 PS|mITT; N=number of evaluable participants analyzed;|||Percentage of participants|||Number
1254922|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 1 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 1 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254923|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Surgery Day|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 1|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
1254924|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 28 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 28 PS|Safety population|||Percentage of participants|||Number
1254925|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 14 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 14 PS|Safety population|||Percentage of participants|||Number
1254926|NCT00468845|Secondary|Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|"m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).~LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata."|Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254927|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 7 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 7 PS|Safety population|||Percentage of participants|||Number
1254928|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Discharge|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Discharge (day 3 up to day 7 PS)|Safety population all participants who were administered at least one dose of double blind medication, and for whom at least one post-baseline safety evaluation was obtained were included.|||Percentage of participants|||Number
1254929|NCT00468845|Secondary|Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254930|NCT00468845|Secondary|Sleep Interference|Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254931|NCT00468845|Secondary|Worst Daily Pain|Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.|Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Deviation|Mean
1254932|NCT00468845|Secondary|Average Daily Pain|Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1263808|NCT00407537|Secondary|Change From Baseline in SBP at Month 12||Baseline, Month 12|FAS, number of participants analyzed refers to number of participants contributing to data.|||mmHg||95% Confidence Interval|Least Squares Mean
1254933|NCT00468845|Secondary|Timed Up-and-Go (TUG)|Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Seconds||Standard Error|Least Squares Mean
1254934|NCT00468845|Secondary|Percent Change From Baseline in Peak Expiratory Flow|Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.|||L/min||Standard Error|Least Squares Mean
1254935|NCT00468845|Secondary|Non-opioid Rescue Medication - Ibuprofen|The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.|24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Grams (g)||Standard Deviation|Mean
1254936|NCT00468845|Secondary|Anxiety Before and After Surgery|Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata|Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254937|NCT00468845|Secondary|Non-opioid Rescue Medication - Paracetamol|The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.|24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Grams (g)||Standard Deviation|Mean
1254938|NCT00468845|Secondary|Integrated Analgesic Score|The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|0-24, 24-48, 48-72 hours PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254939|NCT00468845|Secondary|Total Cumulative Dose of Opioids Following Surgery|Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|24, 48 Hours PS, Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||milligram (mg)||Standard Error|Least Squares Mean
1254940|NCT00468845|Secondary|Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay|Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254941|NCT00468845|Secondary|Current Pain at Rest|Pain reported by participants at rest (numeric rating scale (NRS) – Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|8, 16, 24, 32, 40, 48 hours PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254942|NCT00468845|Secondary|Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test|Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254943|NCT00468845|Secondary|Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting|Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
1254944|NCT00468845|Secondary|Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test|Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1, up to 7 days PS, 2 and 4 weeks PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.|||Units on a scale||Standard Error|Least Squares Mean
1268397|NCT00372775|Secondary|Percentage of Participants Surviving at 1 Year|Percentage of those surviving at end of 1 year from the first dose of study treatment.|Year 1|ITT|||Percentage of participants|||Number
1254945|NCT00468845|Secondary|Current Pain - Pain With Movement Caused by Sitting|Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.|||Units on a scale||Standard Error|Least Squares Mean
1254946|NCT00468845|Primary|Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)|"Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).~Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata."|Day 2 (24 hours post surgery [PS])|Modified intent-to-treat (mITT) population: participants who received at least 1 dose study drug, had at least 1 post baseline safety and efficacy evaluation, took all pre-surgery medication, had no complications during surgery with discontinuation, no PS infection with additional hospitalization/readmission, had primary efficacy measurement PS|||Units on a scale||Standard Error|Least Squares Mean
1254947|NCT00468819|Secondary|Number of Participants With Change in Diagnostic Confidence by Age Group|In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened).|up to 1 hour after Gadobutrol injection|FAS|||Participants|||Number
1254948|NCT00468819|Secondary|Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)|In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
1254949|NCT00468819|Secondary|Post-Contrast Lesion Characterization by Age Group|In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
1254950|NCT00468819|Secondary|Pre-Contrast Lesion Characterization by Age Group|In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
1254951|NCT00468819|Secondary|Post-Contrast Delineation of Lesion/Vessel Border by Age Group|In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
1254952|NCT00468819|Secondary|Pre-Contrast Delineation of Lesion/Vessel Border by Age Group|In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
1254953|NCT00468819|Secondary|Post-Contrast Lesions by Location and by Age Group|Number of lesions on post-contrast images by organ location and age group.|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
1254954|NCT00468819|Secondary|Pre-Contrast Lesions by Location and by Age Group|Number of lesions on pre-contrast images by organ location and age group.|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
1254955|NCT00468819|Secondary|Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group|In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS|||Participants|||Number
1254956|NCT00468819|Secondary|Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group|In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate [compromised quality], 2=partially adequate [evaluation possible], 3=adequate despite artifacts, 4=adequate with excellent quality).|Up to 1 hour after Gadobutrol injection|FAS|||Participants|||Number
1254957|NCT00468819|Secondary|Urinary Excretion of Gadolinium as Percent of Administered Dose|Amount of gadolinium* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. *A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging.|up to 6 hours after Gadobutrol injection|Valid for urinary analysis|||percentage of administered dose||Full Range|Mean
1254958|NCT00468819|Primary|Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group|Mean residence time of Gadobutrol in plasma expressed in h.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set|||hours||Inter-Quartile Range|Median
1254959|NCT00468819|Primary|Terminal Elimination Half Life Estimates of Gadobutrol by Age Group|Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set|||hours||Inter-Quartile Range|Median
1254960|NCT00468819|Primary|Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group|Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol*h/L.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set|||µmol*h/L||Inter-Quartile Range|Median
1254961|NCT00468819|Primary|Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group|Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set|||L/kg||Inter-Quartile Range|Median
1254962|NCT00468819|Primary|Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group|Apparent volume of distribution at steady state expressed in L after intravenous injection.|From injection up to 8 hours after Gadobutrol injection|Final PK analysis set|||L||Inter-Quartile Range|Median
1254963|NCT00468819|Primary|Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group|Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection.|From injection up to 8 hours after Gadobutrol injection|Final PK analysis set|||L/h/kg||Inter-Quartile Range|Median
1254966|NCT00468728|Secondary|Recurrence|Percentage of subjects with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.|Study days 11-40|The analysis population is mITT, for subjects who met the primary endpoint of cure, was analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.|||Percentage of Participants|||Number
1254967|NCT00468728|Primary|Cure Rate at End of Therapy|Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.|Study day 10 (+/- 2 days)|Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by >3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
1254968|NCT00468676|Primary|Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months|"Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 months and 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||percent glycated hemoglobin||Standard Deviation|Mean
1254969|NCT00468676|Primary|LDL Cholesterol at Baseline and 12 Months|"LDL Cholesterol was measured at Baseline and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline and 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||mg/dL||Standard Deviation|Mean
1254970|NCT00468676|Primary|Systolic Blood Pressure at Baseline, 6 Months and 12 Months|"Systolic Blood Pressure was measured at Baseline, 6 months and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 Months, 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||mmHg||Standard Deviation|Mean
1254971|NCT00468676|Primary|Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months|"SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 Months, 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||scores on a scale||Standard Deviation|Mean
1254972|NCT00468676|Secondary|Health Care Costs|Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs|Cumulative outpatient costs over 24 months||||US dollars||Standard Deviation|Least Squares Mean
1254973|NCT00468676|Secondary|Functional Impairment|"Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is not at all and 10 is extremely. This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10."|Measured at Months 6, 12 months||||units on a scale||Standard Deviation|Mean
1254974|NCT00468676|Primary|Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c|A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.|Baseline to 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||unitless||95% Confidence Interval|Number
1254975|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1255019|NCT00468559|Secondary|Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.|||Units on a scale||Standard Deviation|Mean
1254976|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254977|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
1254978|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
1254979|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254980|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254981|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254982|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||Per-patient percentage||Standard Deviation|Mean
1254983|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1255020|NCT00468559|Secondary|Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.|||Units on a scale||Standard Deviation|Mean
1254984|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
1254985|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254986|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254987|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 [“Were you satisfied with this sexual encounter?”] = “Yes”) / (number of occasions where SEP Question 5 was answered “Yes” or “No”)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254988|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 [“Were you satisfied with this sexual encounter?”] = “Yes”) / (number of occasions where SEP Question 5 was answered “Yes” or “No”)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
1254989|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 [“Were you satisfied with the hardness of your erection?”] = “Yes”) / (number of occasions where SEP Question 4 was answered “Yes” or “No”).|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254990|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 [“Were you satisfied with the hardness of your erection?”] = “Yes”) / (number of occasions where SEP Question 4 was answered “Yes” or “No”).|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254991|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1269962|NCT00360334|Secondary|Incidence of Hypoglycemic Episodes|Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study|26 weeks|Full Analysis Set|||percent|||Number
1254992|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
1254993|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 [“Were you able to insert your penis into your partner’s vagina?”] = “Yes”) / (number of occasions where SEP Question 2 was answered “Yes” or “No”).|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254994|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 [“Were you able to insert your penis into your partner’s vagina?”] = “Yes”) / (number of occasions where SEP Question 2 was answered “Yes” or “No”).|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254995|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254996|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
1254997|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1254998|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1254999|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255102|NCT00468286|Secondary|Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.|1 year||||percentage of participants||95% Confidence Interval|Mean
1255000|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255001|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255002|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255003|NCT00468650|Secondary|Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2|QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.|Week 4 and Week 6||||score on scale||Standard Deviation|Mean
1255004|NCT00468650|Secondary|Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline|QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255005|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255006|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255007|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255008|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255103|NCT00468286|Secondary|Serum Levels of Testosterone Over Time||1 year||||ng/mL||Full Range|Median
1295885|NCT00075816|Secondary|Graft Failure||Measured at 28 and 100 days||||percentage of patients||95% Confidence Interval|Number
1255009|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255010|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255011|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255012|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255013|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
1255014|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. Week 6 Endpoint = last observation recorded after Week 2|||score on a scale||Standard Deviation|Mean
1255015|NCT00468650|Primary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 6 LOCF|Modified intent to treat (MITT) population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, last assessment collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||score on scale||Standard Deviation|Mean
1255016|NCT00468585|Primary|Overall Objective Response|This is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria.|2 years||||participants|||Number
1255017|NCT00468559|Secondary|Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|83 patients were analyzed at the screening timepoint, 83 patients were analyzed at week 1 and 78 patients were analyzed at Week 2 due to discontinuations.|||Units on a scale||Standard Deviation|Mean
1255018|NCT00468559|Secondary|Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.|||Units on a scale||Standard Deviation|Mean
1263809|NCT00407537|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4||Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||mmHG||95% Confidence Interval|Least Squares Mean
1255021|NCT00468559|Secondary|Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)|Number of patients who had an improvement of at least one category in the PGA at the end of open-label treatment with esomeprazole compared to baseline. Improvement in PGA was a pre-requisite for randomization into the randomized treatment withdrawal phase. Only patients with PGA at baseline and end of open-label are analyzed here.|Open-label treatment period (2 weeks)|95 patients received open-label esomeprazole during the open-label phase.|||Participants|||Number
1255022|NCT00468559|Secondary|Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained||||Units on a scale||Standard Deviation|Mean
1255023|NCT00468559|Secondary|Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained||||Units on a scale||Standard Deviation|Mean
1255024|NCT00468559|Secondary|Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained||||Units on a scale||Standard Deviation|Mean
1255025|NCT00468559|Secondary|Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained||||Units on a scale||Standard Deviation|Mean
1255026|NCT00468559|Secondary|Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)|Percentage of participants with Physician's Global Assessment (PGA) score at the final treatment withdrawal assessment in following categories: None (no symptoms), Mild, Moderate or Severe. The worst post-randomization Physician's Global Assessment (PGA) assessment during double blind phase is taken into account.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)||||Percentage of participants|||Number
1255027|NCT00468559|Secondary|Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).|"The number of participants reaching the end of the treatment withdrawal phase without discontinuing from the study (for any reason) or showing symptom worsening in the physician global assessment of Gastroesophageal Reflux Disease (GERD) symptoms. Based on the severity of symptoms reported by the parent/guardian in IVRS, the investigator provided the overall clinical impression of the patient’s GERD-related symptoms over the last 7 days as:~None Mild Moderate Severe"|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)||||Participants|||Number
1255028|NCT00468559|Secondary|Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)|Number of participants discontinuing due to any reason was identical to the number of participants discontinuing due to symptom worsening (the primary assessment) when no participants discontinued due to reason other than symptom worsening.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|Reporting cumulative discontinuations. Results for the analysis of the secondary variable, time to discontinuation due to any cause, were identical to that found for the primary variable, time to discontinuation due to symptom.|||Participants|||Number
1255029|NCT00468559|Primary|Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)|Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.|Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|reporting cumulative discontinuations|||Participants|||Number
1255030|NCT00468546|Secondary|Percentage of Participants Without Erosive Progression|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage and negative change score indicates improvement.|Up to Week 104|ITT population included all randomized participants who received any part of an infusion of study medication. Participants with available data at the time of evaluation were analyzed.|||percentage of participants|||Number
1255104|NCT00468286|Primary|Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.|1 year||||percentage of participants||95% Confidence Interval|Mean
1255031|NCT00468546|Secondary|Mean Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score, Genant-modified Sharp Total Score, and Erosion Score|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290. For all the three radiograph assessment, the minimum score is 0. A higher score indicates more damage and a negative change score indicates improvement. The change in score is to be calculated as: Change from Baseline = difference between the score at Weeks 24, 56, or 104 and the score at Baseline.|From Baseline (Day 1) to Weeks (W) 24, 56, and 104|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||units on a scale||Standard Deviation|Mean
1255032|NCT00468546|Secondary|Number of Participants With Change From Baseline in the Mental Component Scores of SF-36|The SF-36 determined participants’ overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on mental component were summed and averaged (range = 0 [worst]-100 [best]); increase from baseline indicated improvement. If participants’ had shown change from baseline in mental health score >6.33, it was considered as improved; scores between -6.33 to 6.33 was considered unchanged, and score <-6.33 was considered as worsened. Change from Baseline = difference between the mental component score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.|||participants|||Number
1255033|NCT00468546|Secondary|Number of Participants With Categorical Change From Baseline in the Physical Component Scores of SF-36|The SF-36 determined participants’ overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on physical component were summed and averaged (range 0 [worst] to 100 [best]); If participants’ had shown change from baseline in physical health component score >5.42, it was considered as improved; score between -5.42 to 5.42 was considered as unchanged, and score < -5.42 was considered as worsened. Change from Baseline = difference between the score of physical component at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.|||participants|||Number
1255034|NCT00468546|Secondary|Mean Change From Baseline of Short Form 36 Total Scores at Week 24|The Short Form (SF)-36 determined participants’ overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Transforming and standardizing these domains leads to the calculation of the physical component summary and mental component summary measures. Scores on each item were summed and averaged (range 0 [worst] to 100 [best]); increase in score from baseline indicated improvement. Change from Baseline = difference between the score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.|||units on a scale||Standard Deviation|Mean
1255035|NCT00468546|Secondary|Percentage Change From Baseline in the ACR Core Set (SJC, TJC, Patient’s and Physician’s Global Assessments, Health Assessment Questionnaire, Pain, C-Reactive Protein, and Erythrocyte Sedimentation Rate) Score|Percentage change in the scores of the following parameters of ACR core set relative to respective baseline scores in both study arms was analyzed : SJC (28 and 66 joints) and TJC (28 and 66 joints), patient’s global assessment and physician’s global assessment based on disease activity (both are expressed by VAS [0 = no disease activity to 100 = maximum disease activity]), HAQ (based on HAQ disability index [HAQDI]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain), CRP concentration, and ESR.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||percent change||Standard Deviation|Mean
1255036|NCT00468546|Secondary|Number of Participants With Good, Moderate, or no European League Against Rheumatism Responses at Week 24|European League Against Rheumatism (EULAR) response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. At a given visit, participants with a DAS28 score of < 3.2 are considered good responders if the change from baseline in their DAS28 score is >1.2. Participants with a DAS28 score >= 3.2 to 5.1 are considered moderate responders if the change from baseline in their DAS28 score is <=1.2 to >=0.6. Participants with DAS28 score >5.1 are considered non-responders if the change from baseline in their DAS28 score is <=1.2 to >=0.6.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||participants|||Number
1255037|NCT00468546|Secondary|Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission at Week 24|The DAS28 is an evaluation index of RA. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC- 28 joints, 2. SJC- 28 joints, 3. ESR or CRP measurement, 4. Participant’s judgement on his own overall health status (GH) expressed by a visual analogue scale VAS (0 [no disease activity] to 100 [maximum disease activity]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10. A participant was categorized as having low disease activity, if participant’s DAS28 score was <= 3.2, and was categorized as having clinical remission if participant’s DAS28 score was < 2.6.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||percentage of participants|||Number
1255038|NCT00468546|Secondary|Mean Change From Baseline in Disease Activity Score of 28 Joints at Week 24|The disease activity score (DAS28) is an evaluation index of rheumatoid arthritis. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC-28 joints, 2. SJC -28 joints, 3. ESR or CRP measurement, 4. Participant’s judgement on his own overall health (global health [GH]) status expressed by a VAS (0 [no disease activity] to 100 [maximum disease activity]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. Change from Baseline = difference between the score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||units on a scale||Standard Deviation|Mean
1255039|NCT00468546|Secondary|Number of Participants With ACR 70 Response at Week 24|ACR 70 response is defined as a >= 70% improvement (reduction) in score compared with baseline for both TJC -68 joints and SJC -66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a VAS ranging from score '0'=no pain to score '100'=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging from score '0'=no disease activity to score '100'=maximum disease activity; HAQ : Health Assessment Questionnaire (HAQ):which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either CRP or ESR.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||participants|||Number
1255040|NCT00468546|Secondary|Number of Participants With an ACR 50 Response at Week 24|ACR 50 response is defined as a >= 50% improvement (reduction) in score compared with baseline for both TJC -68 joints and SJC -66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a VAS ranging from score '0'=no pain to score '100'=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging from score '0'=no disease activity to score '100'=maximum disease activity; HAQ : Health Assessment Questionnaire (HAQ):which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either CRP or ESR.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||participants|||Number
1255041|NCT00468546|Primary|Number of Participants With American College of Rheumatology 20 Response at Week 24|American College of Rheumatology (ACR) 20 response is defined as >= 20% improvement (reduction) in score compared with baseline for both tender joint count (TJC)-68 joints and swollen joint count (SJC)-66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) ranging from score 0 (no pain) to 100 (unbearable pain); Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging score 0 (no disease activity) to 100 (maximum disease activity); Health Assessment Questionnaire (HAQ):8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do) for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR).|Week 24|Intent to treat (ITT) population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||participants|||Number
1255042|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255043|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255044|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255045|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255046|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255047|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255048|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255049|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255050|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255051|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255052|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255053|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
1255054|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
1255055|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
1255056|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255057|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255058|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1257558|NCT00450983|Secondary|Genotype and Phenotype of Donor Killer Cell Immunoglobulin-like Receptor Expression According to Time After Hematopoietic Stem Cell Transplantation (HSCT)||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
1255059|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255060|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255061|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255062|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255063|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255064|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255065|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255066|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255067|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
1255068|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
1255069|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
1255070|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 24|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
1255071|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 20|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
1255072|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 16|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
1288232|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30||Month 30||||L||Standard Error|Mean
1255073|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 12|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
1255074|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 8|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
1255075|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 4|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||µg/L||Standard Deviation|Mean
1255076|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255077|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255078|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255079|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||µg/L||Standard Deviation|Mean
1255080|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
1255081|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255082|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255083|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255084|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
1255085|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
1255086|NCT00468481|Secondary|Mean Neural Tube Defect (NTD) Risk Reduction at Week 24|The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline|Baseline and week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||per 1000 birth||Standard Deviation|Mean
1255118|NCT00468104|Secondary|Number of Participants With Pneumonia That Responded to Therapy|patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed|||participants|||Number
1255087|NCT00468481|Primary|Plasma Folate Level at 24 Weeks|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|Week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||95% Confidence Interval|Least Squares Mean
1255088|NCT00468481|Primary|Red Blood Cell (RBC) Folate Level at 24 Weeks|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|Week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||95% Confidence Interval|Least Squares Mean
1255089|NCT00468312|Secondary|Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15|Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||liters/minute||Standard Deviation|Least Squares Mean
1255090|NCT00468312|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)|The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.|Baseline and 15 days|The RQLQ tool is only validated in participants greater than or equal to 18 years of age. The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age.|||Score on a scale||Standard Deviation|Least Squares Mean
1255091|NCT00468312|Secondary|Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15|Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||Score on a scale||Standard Deviation|Least Squares Mean
1255092|NCT00468312|Primary|Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15|TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||Score on a scale||Standard Deviation|Least Squares Mean
1255093|NCT00468312|Primary|Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15|TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||Score on a scale||Standard Deviation|Least Squares Mean
1255094|NCT00468299|Secondary|Complete Abortion at One Week|Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound|3 weeks|Per protocol|||participants|||Number
1255095|NCT00468299|Primary|Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.||24-48 hrs||||participants|||Number
1255096|NCT00468286|Secondary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|1 year||||participants|||Number
1255097|NCT00468286|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.|Baseline up to 1 year||||participants|||Number
1255098|NCT00468286|Secondary|Serum Levels of Luteinizing Hormone (LH) Over Time||1 year||||IU/L||Full Range|Median
1255099|NCT00468286|Secondary|Serum Levels of Follicle Stimulating Hormone (FSH) Over Time||1 year||||IU/L||Full Range|Median
1255100|NCT00468286|Secondary|Serum Levels of PSA Over Time||1 year||||ng/mL||Full Range|Median
1255101|NCT00468286|Secondary|Probability of no PSA Failure|Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).|1 year||||percentage of participants||95% Confidence Interval|Mean
1257559|NCT00450983|Secondary|Cytomegalovirus-specific T Cells in Product and Donor Graft||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
1255105|NCT00468208|Secondary|Disease Relapse|"Disease relapse was measured by a rise in the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) of greater than or equal to 1 after achieving remission.~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
1255106|NCT00468208|Secondary|Meeting Common Closing|The number of subjects that reached the common closing date.|Number assessed at the time of common closing, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
1255107|NCT00468208|Secondary|Disease Improvement|"Disease improvement was measured by a reduction in the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG).~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
1255108|NCT00468208|Secondary|Disease Remission|"Disease remission was measured by a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) of 0.~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination,up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
1255109|NCT00468208|Primary|Safety of Abatacept - Number of Participants With Adverse Events|"This study examined the safety profile of this agent when used in Wegener's granulomatosis. Information was gathered on all adverse events with specific events being identified in the protocol for analysis that included the following:~Infection~Infusion reactions~Cytopenias~Transaminase elevation~Skin reactions~GI side effects~Malignancy~All adverse events were reportable for this study."|Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
1255110|NCT00468143|Secondary|Self Report|Self-reported adherence was ascertained via retrospective self-report of daily regimen adherence. Participants were considered adherent for Adderall IR (Methamphetamine salts) if they took the first does in the morning within 30 minutes of waking, and then each subsequent dose in 5-hour intervals (within 30 minutes). For Adderall XR (Methamphetamine salts), participants were considered adherent if they took the single daily dose in the morning within 30 minutes of waking. The number given below represents the total number of self-reported adherent participants divided by the total number of participants per group, times 100 (to obtain percentage).|At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)||||percentage of participants adherent|||Number
1255111|NCT00468143|Secondary|Pill Count|Study staff counted unused medication at each weekly visit to yield a percentage of prescribed pills that were consumed. For each group, the number given will be the total number of consumed pills divided by total number of pill prescribed.|At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)||||percentage of pills consumed|||Number
1255112|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Time Adherence|Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)||||percentage of participants adherent|||Number
1255113|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Regimen Adherence|Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)||||percentage of participants adherent|||Number
1255114|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Dosage Adherence|Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|These is the total of participants who completed the study.|||percentage of participants adherent|||Number
1255115|NCT00468104|Secondary|Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy|patients were followed for 6 weeks and resolution of sepsis was documented|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed|||participants|||Number
1255116|NCT00468104|Secondary|Number of Participants With Shortness of Breath That Responded to Therapy|patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed|||participants|||Number
1255117|NCT00468104|Secondary|Number of Participants With Pleural Effusion/Empyema That Responded to Therapy|patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed|||participants|||Number
1269977|NCT00360334|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline to endpoint|26 weeks|Full Analysis Set|||kg/m^2||Standard Error|Least Squares Mean
1255119|NCT00468104|Primary|No Surgical Intervention|CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.|patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months|intention to treat|||participants|||Number
1255120|NCT00468052|Secondary|Participants Requiring Morphine Rescue in PACU||arrival in PACU to 2 hours postoperatively||||participants|||Number
1255121|NCT00468052|Secondary|Number of Participants With SpO2 < or Equal to 95%||on arrival to PACU and 2 hours postoperatively||||participants|||Number
1255122|NCT00468052|Secondary|Time to Extubation|defined as time from end of surgery to tracheal extubation|at end of surgical procedure|per protocol|||minutes||Standard Deviation|Mean
1255123|NCT00468052|Secondary|Time to Awaken|defined as spontaneous eye opening or on command|at end of surgery|per protocol|||minutes||Standard Deviation|Mean
1255124|NCT00468052|Secondary|Hemodynamic Stability|Participants whose heart rate per minute was below 60 intraoperatively. Participants whose systolic blood pressure dremonstrated < 30% decrease from baseline and sustained for 5 minutes received rescue as defined by the protocol.|intraoperatively||||participants|||Number
1255125|NCT00468052|Primary|Duration of Agitation|Cole EA scale 1=calm , 5=unconsolable|on arrival to PACU and for 2 hours postoperatively||||minutes||Standard Deviation|Mean
1255126|NCT00468052|Primary|Emergence Agitation and Pain|"emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated .~Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints of pain"|On arrival to PACU and 2 hours postoperatively|per protocol, OPS, PAED and Cole scale are expressed as median values of the maximum score|||units on a scale||Full Range|Median
1255127|NCT00467961|Primary|To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling Transplantation Followed by Low-dose or no Immunosuppression.|Patients will receive a selectively photodepleted lymphocyte product which will be delivered together with the T cell depleted stem cell product on the day of transplantation. Subjects will receive a conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34-selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized. To determine if selective T cell depletion using the photodepletion procedure can substantially reduce the number of severe acute GVHD (grade III/IV) after transplantation followed by low-dose or no immunosuppression.|Day 90|The study accrued 31 transplant recipents and 30 donors. Of the 31 transplant recipients, there were 24 evaluable recipients. Seven of the 24 recipients did not receive transplantation.|||participants|||Number
1255128|NCT00467896|Primary|Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)|Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of full doses administered||Standard Deviation|Mean
1255129|NCT00467896|Secondary|Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)|HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population|||beats per minute||Standard Deviation|Mean
1255130|NCT00467896|Secondary|Heart Rate (HR) - Iloprost PD-6 (Period I)|HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population|||beats per minute||Standard Deviation|Mean
1255131|NCT00467896|Secondary|Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)|DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population|||mmHg||Standard Deviation|Mean
1255132|NCT00467896|Secondary|Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)|DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population|||mmHg||Standard Deviation|Mean
1255133|NCT00467896|Secondary|Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)|SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population|||mmHg||Standard Deviation|Mean
1255134|NCT00467896|Secondary|Systolic Blood Pressure - Iloprost PD-6 (Period I)|SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population|||mmHg||Standard Deviation|Mean
1255146|NCT00467870|Secondary|Trough Assessments of Serum Total Testosterone Concentrations in Part C2||Screening; day 0; and weeks 4, 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
1255135|NCT00467896|Secondary|Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)|The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of daily doses||Standard Deviation|Mean
1255136|NCT00467896|Primary|Inhalation-times Rate - Iloprost PD-15 (Period II)|Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of full doses administered||Standard Deviation|Mean
1255137|NCT00467896|Secondary|Percentage of Daily Doses Within the 6–9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)|The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of daily doses||Standard Deviation|Mean
1255138|NCT00467896|Secondary|Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)|The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of complete doses||Standard Deviation|Mean
1255139|NCT00467896|Secondary|Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)|The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of complete doses||Standard Deviation|Mean
1255140|NCT00467896|Secondary|Daily Inhalation Duration - Iloprost PD-15 (Period II)|Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||minutes||Standard Deviation|Mean
1255141|NCT00467896|Secondary|Daily Inhalation Duration - Iloprost PD-6 (Period I)|Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||minutes||Standard Deviation|Mean
1255142|NCT00467896|Secondary|Number of Daily Inhalations - Iloprost PD-15 (Period II)|Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||inhalations/day||Standard Deviation|Mean
1255143|NCT00467896|Secondary|Number of Daily Inhalations - Iloprost PD-6 (Period I)|Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||inhalations/day||Standard Deviation|Mean
1255144|NCT00467896|Primary|Inhalation-times Rate - Iloprost PD-6 (Period I)|Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of full doses administered||Standard Deviation|Mean
1255145|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part C2||Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
1255147|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2|Serum total testosterone concentrations outside the normal range are categorized as <300 ng/dL (below lower limit of normal range) and >1000 ng/dL (above upper limit of normal range)|Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||percentage of participants|||Number
1255148|NCT00467870|Secondary|Serum Total Testosterone Concentrations in Part C2||Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
1255149|NCT00467870|Secondary|Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2||Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||pg/mL||Standard Deviation|Mean
1255150|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2||Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||percentage of participants|||Number
1255151|NCT00467870|Secondary|Change in Weight From Baseline to Week 24 in Part C||Baseline, Week 24|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis|||kg||Standard Deviation|Mean
1255152|NCT00467870|Secondary|Change in Body Mass Index From Baseline to Week 24 in Part C|Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2)|Baseline, Week 24|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis|||kg/m2||Standard Deviation|Mean
1255153|NCT00467870|Secondary|Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C|M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied).|Day 21 post injection at week 14|Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255154|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255155|NCT00467870|Secondary|Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C|Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255156|NCT00467870|Secondary|Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations <300 ng/dL were also excluded from analysis|||days||Standard Deviation|Mean
1255157|NCT00467870|Secondary|Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255158|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255159|NCT00467870|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C|Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255160|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255161|NCT00467870|Secondary|Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C|Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255162|NCT00467870|Secondary|Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations <300 ng/dL were also excluded from analysis|||days||Standard Deviation|Mean
1255163|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255164|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255165|NCT00467870|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C|Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255166|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part B||Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80|Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (2 from B-TU 750 mg and 12 from B-TU 1000 mg)|||ng/dL||Standard Deviation|Mean
1255167|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part A||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120|Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (20 from A-TU 750 mg and 11 from A-TU 1000 mg)|||ng/dL||Standard Deviation|Mean
1255168|NCT00467870|Primary|Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2|Serum total testosterone Ctrough derived from the 2nd injection IPK interval|Day 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
1255169|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2|Serum total testosterone Cmax derived from the 2nd injection IPK interval|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
1255170|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2|Serum total testosterone Cavg derived from the 2nd injection IPK interval|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
1255171|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2|Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||percentage of participants|||Number
1255172|NCT00467870|Primary|Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C|Serum total testosterone Ctrough derived from the 4th injection IPK interval|Day 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
1255173|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C|Serum total testosterone Cmax derived from the 4th injection IPK interval|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
1255190|NCT00467857|Secondary|Post-CABG Procedure Bacterial Count - Sternal Site|Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.|Post-surgery|Per protocol|||log CFU/mL||Standard Deviation|Mean
1255174|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C|Serum total testosterone Cavg derived from the 4th injection IPK interval|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
1255175|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C|Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval.|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255176|NCT00467870|Primary|Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C|Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval|Day 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
1255177|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C|Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
1255178|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C|Serum total testosterone Cavg derived from the 3rd injection IPK interval|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
1255179|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C|Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval.|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
1255180|NCT00467857|Secondary|Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)|Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site|30 days|Subset of Intention to treat participants with alcohol use, tobacco use, or obesity|||Participants|||Number
1255181|NCT00467857|Secondary|Number of Patients With SSI at the Sternal Site and/or Graft Site|Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period|30 days|Intention to treat|||Participants|||Number
1255182|NCT00467857|Secondary|Post-incision Bacterial Count - Graft Site|Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision|Immediately after surgical incision|Per protocol|||log CFU/mL||Standard Deviation|Mean
1255183|NCT00467857|Secondary|Post-incision Bacterial Count - Sternal Site|Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision|Immediately after surgical incision|Per protocol|||log CFU/mL||Standard Deviation|Mean
1255184|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site|Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)|Before surgery (prior to skin preparation) and immediately after incision|Per protocol|||log CFU/mL||Standard Deviation|Mean
1255185|NCT00467857|Primary|Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site|Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol|||isolates||Standard Deviation|Mean
1255186|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site|Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)|Before surgery (prior to skin preparation) and immediately after incision|Per protocol|||log CFU/mL||Standard Deviation|Mean
1255187|NCT00467857|Secondary|Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site|Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and immediately after incision|Per protocol|||isolates||Standard Deviation|Mean
1255188|NCT00467857|Secondary|Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site|Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and immediately after incision|Per protocol|||isolates||Standard Deviation|Mean
1255189|NCT00467857|Secondary|Post-CABG Procedure Bacterial Count - Graft Site|Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.|Post-surgery|Per protocol|||log CFU/mL||Standard Deviation|Mean
1295886|NCT00075816|Secondary|Platelet Engraftment||Measured at Day 180||||percentage of patients||95% Confidence Interval|Number
1255191|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site|Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol|||log CFU/mL||Standard Deviation|Mean
1255192|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site|Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol|||log CFU/mL||Standard Deviation|Mean
1255193|NCT00467857|Primary|Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site|Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol|||isolates||Standard Deviation|Mean
1255194|NCT00467844|Secondary|To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.|Change in stair climb power from baseline to 4 months. Stair climb power is defined power (watts)=[9.8 m/sec**2]*[weight (kg)]*[height of 12 steps(meters)]/ [time (seconds) up the 12 steps].|Four Months|The subjects were in the MITT population (had a post baseline DEXA) and had a month 4 stair climb assessment (observed cases).|||watts||Full Range|Median
1255195|NCT00467844|Primary|The Efficacy of GTx-024 on Total Body Lean Mass.|Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.|Baseline to Four Months|The number of participants were those subjects in the modified intent-to-treat population (defined as subjects with at least one post baseline DEXA for LBM) who had baseline and 4 month DEXA results for LBM (observed cases).|||kg||Full Range|Median
1255196|NCT00467831|Primary|Survival at 2 Years|The number of subjects surviving after 24 months on study.|24 months||||participants|||Number
1255197|NCT00467779|Secondary|Stage III: AUC0-inf of Midazolam|AUC0-inf is the AUC from time 0 to infinity and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
1255198|NCT00467779|Secondary|Stage III: AUC0-24 of Midazolam|AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was calculated both in the presence (Cycle 1 Day 15) and absence (CXycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
1255199|NCT00467779|Secondary|Stage III: Cmax of Midazolam|Cmax is the maximum observed plasma concentration and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Geometric Mean
1255200|NCT00467779|Secondary|Stage III: AUC 0-inf of Dextromethorphan|AUC0-inf is AUC from time 0 to infinity and was calculated both in presence Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
1255201|NCT00467779|Secondary|Stage III: AUC 0-24 of Dextromethorphan|AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was determined both in presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
1255202|NCT00467779|Secondary|Stage III: Cmax of Dextromethorphan|Cmax is defined as maximum observed plasma concentration and was determined both in the presence (Cycle 1 Day 15) and absence of cobimetinib (Cycle 1 Day 1).|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n=number of participants analyzed for specified category.|||ng/mL||Standard Deviation|Geometric Mean
1255203|NCT00467779|Secondary|Stage 2A: Cmax of Cobimetinib at Steady State|Cmax is the maximum plasma concentration achieved following the Day 20 dose in Stage 2A.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Analysis population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Geometric Mean
1255204|NCT00467779|Secondary|Stage 2A: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 2A in steady state.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1255205|NCT00467779|Secondary|Stage 2A: Half-Life of Cobimetinib at Steady State||Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1257560|NCT00450983|Secondary|Concentration of NK, NK-T, T-cells, and Dendritic Cell Subsets in the CD34+ NK/NK-T-enriched Graft||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
1255206|NCT00467779|Secondary|Stage 2A: Apparent Clearance of Cobimetinib at Steady State|Apparent clearance is the plasma clearance of absorbed drug.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Standard Deviation|Mean
1255207|NCT00467779|Secondary|Stage 2A: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio AUC0-24 is ratio of AUC on Day 20: Day 1.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Standard Deviation|Mean
1255208|NCT00467779|Secondary|Stage 2A: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Mean
1255209|NCT00467779|Secondary|Stage 2:Half-Life of Cobimetinib at Steady State|T1/2 half-life of cobimetinib measured over the terminal phase by noncompartmental analysis.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1255210|NCT00467779|Secondary|Stage 2: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population|||L/hr||Standard Deviation|Mean
1255211|NCT00467779|Secondary|Stage 2: Accumulation Ratio of Cobimetinib at Steady State|Accumulation ratio is AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Standard Deviation|Geometric Mean
1255212|NCT00467779|Secondary|Stage 2: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
1255213|NCT00467779|Secondary|Stage 2: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
1255214|NCT00467779|Secondary|Stage 2: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 2 in steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only; Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1255215|NCT00467779|Secondary|Stage 2: Tmax of Cobimetinib at Cycle 1 Day 1|Tmax is defined as the time to reach Cmax during stage 2 on Day 1.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1255216|NCT00467779|Secondary|Stage 2:AUC 0-24 of Cobimetinib at Cycle 1 Day 1|The area under the AUC0-24 on Day 1 in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
1255217|NCT00467779|Secondary|Stage 2: Cmax of Cobimetinib at Cycle 1 Day 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 2 and was measured in ng/mL.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Geometric Mean
1255218|NCT00467779|Secondary|Stage 1A: Cmax of Cobimetinib at Steady State|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1A and was measured in steady state as ng/mL.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Mean
1255245|NCT00467740|Secondary|Laboratory Testing: Average Change From Baseline of Potassium|Laboratory testing: Average change from baseline of potassium measured on test-days. Pre−dose value on test day 1 is the baseline value.|Baseline and 29 days|Treated Set|||mmol/L||Inter-Quartile Range|Geometric Mean
1255219|NCT00467779|Secondary|Stage 1A: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng*hr/mL/mg||Standard Deviation|Mean
1255220|NCT00467779|Secondary|Stage 1A: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 1A was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Mean
1255221|NCT00467779|Secondary|Stage 1A: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Standard Deviation|Mean
1255222|NCT00467779|Secondary|Stage 1A: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number pf participants analyzed = participants who were evaluable for this outcome.|||L/hr||Standard Deviation|Mean
1255223|NCT00467779|Secondary|Stage 1A: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 1A in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1255224|NCT00467779|Secondary|Stage 1A: t1/2 of Cobimetinib at Steady State|t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1A in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1255225|NCT00467779|Secondary|Stage 1A: AUC 0-24 of Cobimetinib at Cycle 1 Day 1|AUC0-24 for stage 1A was calculated on Day 1 with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.|||h*ng/mL||Standard Deviation|Mean
1255226|NCT00467779|Secondary|Stage 1A: Cmax of Cobimetinib at Cycle 1 Day 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on on Day 1 in Stage 1A and was measured as ng/mL.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.|||ng/mL||Standard Deviation|Mean
1255227|NCT00467779|Secondary|Stage 1A: Tmax of Cobimetinib at Cycle 1 Day 1|Tmax is defined as the time to reach Cmax during stage 1A at Day 1.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.|||hours||Full Range|Median
1255228|NCT00467779|Secondary|Stage 1: Cmax of Cobimetinib at Steady State|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1 and was measured at steady state in ng/mL.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Mean
1255229|NCT00467779|Secondary|Stage 1: Half-Life (t1/2) of Cobimetinib at Steady State|t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1 in steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1255230|NCT00467779|Secondary|Stage 1: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||Liters per hour (L/hr)||Standard Deviation|Mean
1255231|NCT00467779|Secondary|Stage 1: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Standard Deviation|Mean
1255232|NCT00467779|Secondary|Stage 1: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety Population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng*hr/mL/mg||Standard Deviation|Mean
1255233|NCT00467779|Secondary|Stage 1: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 1 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Mean
1255234|NCT00467779|Secondary|Stage 1: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 1 in steady state. Steady state was reached when overall intake of cobimetinib was in dynamic equilibrium with its elimination.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1255235|NCT00467779|Primary|Stage 1: Time to Maximum Concentration (Tmax) of Cobimetinib at Day 1, Cycle 1|Tmax is defined as the time to reach Cmax during stage 1 at Day 1 Cycle 1.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.|||hours||Full Range|Median
1255236|NCT00467779|Primary|Stage 1: Area Under the Plasma Cobimetinib Concentration Curve From Time 0 to 24 Hours (AUC 0-24) Day 1, Cycle 1|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samples. AUC is measured as hours times nanograms per milliliter (h*ng/mL).|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.|||h*ng/mL||Standard Deviation|Geometric Mean
1255237|NCT00467779|Primary|Stage 1: Maximum Observed Concentration (Cmax) of Cobimetinib at Day 1, Cycle 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on Day 1, Cycle 1 in Stage 1 and was measured as nanograms per milliliter (ng/mL).|Stage 1: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.|||ng/mL||Standard Deviation|Geometric Mean
1255238|NCT00467779|Primary|Stage 1A: MTD of Cobimetinib in 14/14 Schedule|"AEs were graded according to NCI-CTCAE v3.0. A DLT was the basis for determining MTD in Stage 1A participants. The participants of Stage 1A are dose-escalation cohorts, starting at the MTD of the 21/7 schedule, were treated on a 14/14 schedule to determine the MTD. A DLT was defined as either of the following occurring during the Study Treatment Period:~Occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants to risk of irreversible medical harm; Nonhematologic toxicity: Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment; Hematologic toxicity: Grade 4 thrombocytopenia. Grade 4 neutropenia of more than 4 days’ duration; Grade 4 neutropenia of any duration with fever or documented infection. AEs (Grade 3 or higher) for which a clinical cause unrelated to cobimetinib was evident was not considered DLTs."|Stage 1A: Days 1 to 28 of Cycle 1|Safety population; Stage 1A participants only.|||mg|||Number
1255239|NCT00467779|Primary|Stage 1: Maximum Tolerated Dose (MTD) of Cobimetinib in 21/7 Schedule|"AEs were graded according to the NCI-CTCAE v3.0. A DLT was determined from clinical findings during the Study Treatment Period (Cycle 1, Days 1). MTD was defined as the dose at which no DLTs were observed. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity~Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity~Grade 4 thrombocytopenia~Grade 4 neutropenia of greater than or equal to (≥) 4 days’ duration~Grade 4 neutropenia of any duration with fever or documented infection"|Stage 1: Days 1 to 28 of Cycle 1|Safety population; Stage 1 participants only.|||milligrams (mg)|||Number
1255240|NCT00467779|Primary|Stage 1 and 1A: Number of Participants With Dose Limiting Toxicities (DLTs)|"Adverse events (AE) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the cohort review committee (CRC), was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity~Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity~Grade 4 thrombocytopenia~Grade 4 neutropenia of greater than or equal to (≥) 4 days’ duration~Grade 4 neutropenia of any duration with fever or documented infection"|Stage 1 and 1A: Days 1 to 28 of Cycle 1|Safety population; Stages 1 and 1A participants only.|||participants|||Number
1255241|NCT00467753|Primary|Autism Diagnostic Observation Schedule||Evaluated during Baseline and Termination|||||||
1255242|NCT00467753|Primary|Clinical Global Impression Improvement Scale||Once a week|||||||
1255243|NCT00467753|Primary|Aberrant Behavior Checklist||Bi weekly|||||||
1255244|NCT00467753|Primary|Vineland Adaptive Behavior Scales||Evaluated during Baseline and Termination|||||||
1288233|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30||Month 30||||L||Standard Error|Mean
1255246|NCT00467740|Secondary|Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination|Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.|4 weeks|Treated set|||participants|||Number
1255247|NCT00467740|Secondary|Total Score in Asthma Control Questionnaire After 4 Weeks|Adequacy of asthma control was assessed using a scale of: 0=totally controlled, to 6=Severely uncontrolled.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||units on a scale||Standard Error|Least Squares Mean
1255248|NCT00467740|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||hours||Full Range|Median
1255249|NCT00467740|Secondary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1255250|NCT00467740|Secondary|Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)|AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=24 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1255251|NCT00467740|Secondary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=6 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1255252|NCT00467740|Secondary|Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)|AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1255253|NCT00467740|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||hours||Full Range|Median
1255254|NCT00467740|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1255255|NCT00467740|Secondary|Area Under Curve From 0 to 3 Hours (AUC0-3)|AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1255256|NCT00467740|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (prn salbutamol [albuterol]) as assessed by the e-Diary (e-Diary incorporated in AM2+).|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Number of Puffs||Standard Error|Least Squares Mean
1255257|NCT00467740|Secondary|PEFR Variability After 4 Weeks|PEFR variability represents the absolute difference between the highest morning PEFR value and the highest evening PEFR value of 1 day, divided by the arithmetic mean of these 2 PEFR values and expressed as a percent, weekly means.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||percentage of PEFR||Standard Error|Least Squares Mean
1255258|NCT00467740|Secondary|Weekly Mean Evening PEFR After 4 Weeks|Response was defined as change from baseline. Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter/minute||Standard Error|Least Squares Mean
1255259|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 6-12 h (AUC 6-12h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior to dose on first day of randomized treatment (baseline) and 1h, 3h, 6h, 9h, 12h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255260|NCT00467740|Secondary|Peak FVC (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255261|NCT00467740|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255262|NCT00467740|Secondary|Peak FVC (0-3h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255263|NCT00467740|Secondary|Peak FVC (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255264|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255265|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255266|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255267|NCT00467740|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255268|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255280|NCT00467740|Primary|Trough FEV1 Response After 4 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255269|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255270|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255271|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255272|NCT00467740|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255273|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255274|NCT00467740|Secondary|Trough FVC Response After 4 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255275|NCT00467740|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255276|NCT00467740|Secondary|Trough FVC Response After 1 Week|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255277|NCT00467740|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255278|NCT00467740|Secondary|Trough FEV1 Response After 1 Week|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1255279|NCT00467740|Secondary|Weekly Mean Pre-dose Morning PEFR After 4 Weeks|Response was defined as change from baseline. Baseline peak expiratory flow response (PEFR) was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter/minute||Standard Error|Least Squares Mean
1255316|NCT00467363|Secondary|Molar Pregnancy||8 weeks||||pregnancy|||Number
1255317|NCT00467363|Secondary|Ectopic Pregnancy||within 6 weeks||||pregnancy|||Number
1255281|NCT00467649|Other Pre-specified|Hypoglycemia Adverse Events|"MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating.~MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion).~SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention."|36 weeks||||participants|||Number
1255282|NCT00467649|Secondary|Phase 2: Change in Body Weight at Week 36|Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).|Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2 Intent-to-Treat|||kg||Standard Error|Mean
1255283|NCT00467649|Secondary|Phase 2: Change in HbA1c at Week 36|Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).|Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2 Intent-to-Treat|||Percent||Standard Error|Mean
1255284|NCT00467649|Secondary|Fasting Serum Lipids Change From Baseline to Week 24||Baseline, week 24|Phase 1 Intent-to-Treat|||mg/dL||Standard Error|Mean
1255285|NCT00467649|Secondary|Change in Fasting Plasma Glucose From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat|||mg/dL||Standard Error|Mean
1255286|NCT00467649|Secondary|Change in Waist Circumference From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.|||cm||Standard Error|Least Squares Mean
1255287|NCT00467649|Secondary|Change in Body Weight From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.|||kg||Standard Error|Least Squares Mean
1255288|NCT00467649|Secondary|Change in HbA1c From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.|||Percent||Standard Error|Least Squares Mean
1255289|NCT00467649|Secondary|Percentage of Patients With a Severe Hypoglycemia Adverse Event|This is a component of the primary endpoint.|24 Weeks|Phase 1 Intent-to-Treat|||Percent|||Number
1255290|NCT00467649|Secondary|Percentage of Patients With no Weight Gain at Week 24|This is a component of the primary endpoint|24 Weeks|Phase 1 Intent-to-Treat|||Percent|||Number
1255291|NCT00467649|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 24|This is a component of the primary endpoint|24 Weeks|Phase 1 Intent-to-Treat|||Percent|||Number
1255292|NCT00467649|Primary|The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia|A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.|24 Weeks|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.|||Percent|||Number
1255293|NCT00467610|Secondary|Hematological Improvement Rate at Week 8 as Defined by the IWG 2000 Criteria for Response Assessment, 2000 Version||At 8 weeks from start of therapy||||participants|||Number
1255294|NCT00467610|Primary|Response Rate ( CR+PR) at Week 8, Based on the IWG Criteria for Response Assessment ( 2000 Version)|"Complete response(CR): <5% blasts in the bone marrow,with normal maturation of all cell lines, Hemoglobin >11 g/dL, neutrophils>1500/mm3 platelets>100,000/mm3.~Partial response (PR): >50% decrease in blasts, or less advanced IPSS than pretreatment value, same hematological parameters as in CR.~Stable disease (SD): No evidence of disease progression in bone marrow, stable peripheral blood counts failure: Increase in bone marrow blast percentage, progression to more advanced IPSS than pretreatment and worsening of cytopenias.~(Cheson, 2000)"|After 8 weeks of therapy with panhematin||||Participants|||Number
1255295|NCT00467610|Secondary|Number of Patients Demonstrating Hematological Improvement to Panhematin® at Week 4.|"Hematological improvement (HI)~Major:~HI-Erythroid:>2 g/dL rise in hemoglobin, or transfusion independence HI-Neutrophil: Absolute increase of >500/mm3, or >100% increase HI-Platelet: Absolute increase of >30,000, or transfusion independence~Minor:~HI-Erythroid:1 to 2 g/dL increase in hemoglobin or 50% decrease in transfusion dependence.~HI-P: For patients with pretreatment platelet count < 100,000/mm3, ≥ 50% increase with a net increase > 10,000/mm3 but < 30,000/mm3.~HI-N: For patients with pretreatment ANC < 1500/mm3, ≥ 100% increase, but < 500/mm3 increase."|4 weeks after initiation of treatment with Panhematin||||participants|||Number
1255296|NCT00467610|Primary|Safety and Tolerability of Panhematin®.|Number of patients with no adverse events.|participants were followed during therapy with panhematin, and up to six months post completion of therapy, average of 8 months.||||participants|||Number
1255297|NCT00467597|Primary|Gaitmat Stance Measurements (AUC)|Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am.|Every 1/2 hour during an 8 hour period.||||Root Mean Square of Velocity*Minutes||Standard Deviation|Mean
1255318|NCT00467363|Secondary|Stillbirth||40 weeks||||participants|||Number
1255319|NCT00467363|Secondary|Fetal Pregnancy Loss||until 40 weeks||||pregnancy|||Number
1255320|NCT00467363|Secondary|Pregnancy Losses Occurring Less Than 10 Weeks|Includes preembryonic and embryonic losses (exclusive of implantation failures)|less than 10-weeks||||pregnancy|||Number
1255298|NCT00467584|Primary|Modified Fatigue Impact Scale Score|The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always) were provided by the study subjects for the prior 4 week period. A total score was tallied from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.|Baseline, 8 weeks|62 patients were randomized; of these, 6 did not receive the intervention and an additional 4 discontinued without providing followup data. Therefore 52 were included in the analysis. The Wk 4 MFIS score was used if the subject withdrew prior to Wk 8. 1 subject each in the High Dose and Placebo groups provided MFIS data at Wk 4 but not Wk 8.|||units on a scale||Standard Deviation|Mean
1255299|NCT00467558|Primary|Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)|The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).|Assessed at each visit (every two weeks) until participation in the study was done (Week 8)|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
1255300|NCT00467558|Secondary|Clinical Global Impression Scale - Severity|The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = “very much improved” to 7 = “very much worse.” The CGI severity scale was used at each visit and ranges from 1 = “not ill at all” to 7 = “among the most extremely ill.”|Assessed at each visit (every two weeks) until participation in the study was done (Week 8)|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
1255301|NCT00467519|Primary|Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis|Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Pre-dose and 30 Days Post-vaccination|Geometric mean titers were assessed in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
1255302|NCT00467519|Primary|Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus|"Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL.~Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA)."|30 Days post-vaccination|Diphtheria and tetanus antibody booster response were analysed in all enrolled and vaccinated participants, per-protocol population.|||Percentage of Participants|||Number
1255303|NCT00467519|Other Pre-specified|Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination|Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1255304|NCT00467519|Primary|Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis|"Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL~Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA)."|30 Days post-vaccination|Pertussis antibody booster response analysis was in all enrolled and vaccinated participants in the per-protocol population.|||Percentage of Participants|||Number
1255305|NCT00467519|Primary|Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL|"Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL.~Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA)."|Pre-dose and 30 days post-vaccination|Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.|||Percentage of Participants|||Number
1255306|NCT00467519|Primary|Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level|"Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL.~Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA)."|Pre-dose and 30 days post-vaccination|Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.|||Percentage of Participants|||Number
1255307|NCT00467389|Secondary|Cocaine Pharmacokinetics|Area-Under-the-Curve for Plasma Concentration|0 to 8 hours||||ng-hr/ml||Standard Error|Mean
1255308|NCT00467389|Secondary|Cocaine Subjective Effects|Cocaine Induced 'High' by VAS (visual analogue scale, between 3 and 30 minutes after intravenous dosing, in mm). VAS results ranged from 0 (minimum effect) to 100 (maximum effect).|3 to 30 minutes||||mm||Standard Error|Mean
1255309|NCT00467389|Primary|Cocaine Safety in Subjects Receiving Donepezil|Patients evaluated for clinical and laboratory adverse events|Two weeks|All participants included|||Participants with an Adverse Event|||Number
1255310|NCT00467363|Secondary|Abruption|Partial or complete abruption (ie, premature separation of the placenta)|until delivery||||participants|||Number
1255311|NCT00467363|Secondary|Fetal Intolerance of Labor||until delivery|No data were collected for this Outcome Measure.||||||
1255312|NCT00467363|Secondary|Abnormal Fetal Testing||8 weeks|No data were collected for this Outcome Measure.||||||
1255313|NCT00467363|Secondary|Preterm Birth||until delivery||||infants|||Number
1255314|NCT00467363|Secondary|Small for Gestational Age Infant|birthweight|until delivery||||grams||Standard Deviation|Mean
1255315|NCT00467363|Secondary|Preeclampsia||until delivery||||participants|||Number
1255333|NCT00467285|Primary|Changes in BMD at Femoral Neck|% changes in BMD ( BMD at Lumbar spine, femoral neck and 0.33 radius) and bone turn over markers in subjects with diabetes on pioglitazone compared to those who are not on Pioglitazone|6 months|28 subjects on pioglitazone and 64 subjects not on pioglitazone|||percentage of change in BMD||Standard Deviation|Mean
1255334|NCT00467259|Secondary|Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.|||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
1255335|NCT00467259|Secondary|Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.|||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
1255336|NCT00467259|Primary|Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.|||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
1255337|NCT00467077|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 5 years.||||Months||95% Confidence Interval|Median
1255338|NCT00467077|Secondary|Progression-Free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression, up to 5 years.||||Months||95% Confidence Interval|Median
1255339|NCT00467077|Secondary|Number of Participants With Overall Response as Measured by RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR|After 2 cycles of treatment, up to 2 years.||||participants|||Number
1255340|NCT00467077|Primary|Six-month Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions|From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||percentage of participants||95% Confidence Interval|Number
1255341|NCT00467051|Secondary|The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.||Two cycles of chemotherapy; expected to be 42 days of treatment.|All eligible patients.|||Participants|||Count of Participants
1255342|NCT00467051|Primary|Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.|At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)||||participants|||Number
1255343|NCT00467038|Secondary|Group x Time Interaction Amygdala Activity|0 to 12 month difference scores in group x time interaction amygdala activity|Baseline and 12 months||||bold signal units||Standard Deviation|Mean
1255344|NCT00467038|Primary|Self-Report of Difficulties in Emotion Regulation (DERS)|"The present study examines DBT treatment effect on emotion regulation in unmedicated outpatients with BPD as measured by changes in the Difficulties in Emotion Regulation Scale. The DERS is a brief, 36-item, self-report questionnaire.~DERS total score ranges from 36- 180. Higher scores reflect higher difficulties in emotion regulation.~The measure yields a total score as well as scores on six scales derived through factor analysis:~1. Nonacceptance of emotional responses, 2. Difficulties engaging in goal directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to emotion regulation strategies, 6. Lack of emotional clarity Responses are on a 5-point scale: 1=almost never, 2=sometimes, 3=about half the time, 4=most of the time, 5=almost always"|12 months|22 age- and gender-matched unmedicated BPD and HC participants (11 in each group).|||units on a scale||Standard Deviation|Mean
1255345|NCT00466960|Secondary|Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens|Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.|Up to 5 years||||Pearson correlation||95% Confidence Interval|Number
1255346|NCT00466960|Secondary|Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens|Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.|Up to 5 years||||Pearson correlation||95% Confidence Interval|Number
1255347|NCT00466960|Secondary|Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration|Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).|Up to 5 years||||% of CD45+PBMC||Inter-Quartile Range|Median
1255348|NCT00466960|Secondary|Correlation Between Circulating Monocytes and Time to Progression|Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).|Up to 5 years||||percentage of CD45+ in PBSC||Inter-Quartile Range|Median
1255349|NCT00466960|Primary|Response Rate|Number of patients achieving a complete or partial response.|Up to 5 years||||Participants|||Count of Participants
1255350|NCT00466960|Primary|Time to Progression|Median time to progression|Up to 5 years||||months||95% Confidence Interval|Median
1295887|NCT00075816|Secondary|Neutrophil Engraftment||Measured at Day 28||||percentage of patients|||Number
1255351|NCT00466947|Secondary|Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset.|A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255352|NCT00466947|Secondary|Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255353|NCT00466947|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset|ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1255354|NCT00466947|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset|ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1255355|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST).|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255356|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255357|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255358|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1257561|NCT00450983|Secondary|Risk for Life-threatening Infections|Count of participants with life-threatening infections|Up to day 100||||Participants|||Count of Participants
1255359|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Titers||95% Confidence Interval|Geometric Mean
1255360|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Titers||95% Confidence Interval|Geometric Mean
1255361|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Titers||95% Confidence Interval|Geometric Mean
1255362|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination,|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Titers||95% Confidence Interval|Geometric Mean
1255363|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) .|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255364|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255365|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255366|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255448|NCT00466661|Secondary|Young Mania Rating Scale Score|YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||score on a scale||Standard Deviation|Mean
1257562|NCT00450983|Secondary|Risk for Graft Failure|Count of participant that had graft failure.|Engraftment documented day +20||||Participants|||Count of Participants
1255367|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255368|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed with the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255369|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255370|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
1255371|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||µg/mL||95% Confidence Interval|Geometric Mean
1255372|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||µg/mL||95% Confidence Interval|Geometric Mean
1255373|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||µg/mL||95% Confidence Interval|Geometric Mean
1255401|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1257563|NCT00450983|Secondary|Risk for Mortality From Infection Before Day 180|Count of participant deaths from infection up to day 180.|Up to day 180||||Participants|||Count of Participants
1255374|NCT00466947|Secondary|Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.|Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||µg/mL||95% Confidence Interval|Geometric Mean
1255375|NCT00466947|Secondary|Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset.|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
1255376|NCT00466947|Secondary|Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset.|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
1255377|NCT00466947|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
1255378|NCT00466947|Secondary|Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset|Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
1255379|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset|S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
1255380|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.|Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
1255381|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.|"The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum.~The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama."|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
1255382|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Disease (ID) Due to Haemophilus Influenzae|No subject was reported with any case of ID due to Haemophilus influenzae.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25||2050-12-31|12/2050||||
1255383|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes.|The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255384|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes.|The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255385|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID)|A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255386|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID).|A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255387|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD).|A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255388|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off.|CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255389|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading|A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255390|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR)|An “abnormal CXR” was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255391|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP)|An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255392|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT).||Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255421|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).|Gross Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam gross motor score were analyzed|||units on a scale||Standard Error|Mean
1255452|NCT00466661|Secondary|Percent Carbohydrate-deficient Transferrin|Measured level of validated serum alcohol biomarker|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||"percent CDT"||Standard Deviation|Mean
1255393|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT)|An “abnormal CXR” was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255394|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT)|A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255395|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset|Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255396|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255397|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255398|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset.|Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255399|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset.|The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255400|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset|The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255449|NCT00466661|Secondary|Montgomery Asberg Depression Rating Scale Score|MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||score on a scale||Standard Deviation|Mean
1255402|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP)|CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255403|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks after Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
1255404|NCT00466947|Secondary|Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.|||Subjects|||Number
1255405|NCT00466947|Secondary|Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.|||Subjects|||Number
1255406|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration.|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.|||Subjects|||Number
1255407|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.|||Subjects|||Number
1255408|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.|||Subjects|||Number
1255409|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.|||Subjects|||Number
1255410|NCT00466947|Secondary|Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects included in the Panama subset.|||Subjects|||Number
1255411|NCT00466947|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects whose data were exploited towards analysis of results at the end of the study.|||Subjects|||Number
1255450|NCT00466661|Secondary|Obsessive Compulsive Drinking Scale Score|Higher scores indicate worse outcome; minimum score = 0, maximum score = 40|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||score on a scale||Standard Deviation|Mean
1257564|NCT00450983|Primary|Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)|Count of participants with acute GVHD grades III-IV.|Up to day 100||||Participants|||Count of Participants
1255412|NCT00466947|Primary|Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)|"A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose.~After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome."|Any time from 2 weeks after Dose 3 up to 31 August 2010|Analysis was performed on the Interim ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of 31 August 2010.|||Subjects|||Number
1255413|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).|Motor composite score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam motor composite score were analyzed|||units on a scale||Standard Error|Mean
1255414|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).|Gross motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment.|only subjects that were randomized and had the 24 month Bayleys exam gross motor score were analyzed|||units on a scale||Standard Error|Mean
1255415|NCT00466817|Secondary|Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).|Fine motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam fine motor were analyzed|||units on a scale||Standard Error|Mean
1255416|NCT00466817|Secondary|Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).|Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam language composite score were analyzed|||units on a scale||Standard Error|Mean
1255417|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).|Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam expressive communications scaled score were analyzed|||units on a scale||Standard Error|Mean
1255418|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).|Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores are between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cognitive skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam cognitive composite score were analyzed|||units on a scale||Standard Error|Mean
1255419|NCT00466817|Secondary|Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).|Receptive Communication Scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam receptive communication scaled were analyzed|||units on a scale||Standard Error|Mean
1255420|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).|Motor Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam motor composite score were analyzed|||units on a scale||Standard Error|Mean
1255451|NCT00466661|Secondary|Gamma-glutamyltransferase|Measured levels of validated serum alcohol biomarker|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||Gamma-glutamyltransferase U/L||Standard Deviation|Mean
1271006|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1255422|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).|Fine Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam fine motor score were analyzed|||units on a scale||Standard Error|Mean
1255423|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).|Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam language composite score were analyzed|||units on a scale||Standard Error|Mean
1255424|NCT00466817|Secondary|Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).|Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam expressinve Communications scaled score were analyzed|||units on a scale||Standard Error|Mean
1255425|NCT00466817|Secondary|Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).|Receptive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam Receptive Communications scorewere analyzed|||units on a scale||Standard Error|Mean
1255426|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).|Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cogonitive skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam Cognitive Composite Score were analyzed|||units on a scale||Standard Error|Mean
1255427|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.|||ears|||Number
1255428|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods|||ears|||Number
1255446|NCT00466687|Primary|Number of Patients With Response|Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|At 6 months|Patients for whom a response could be determined. Three patients were not available for measurement of response: no data (2) and toxicity (1).|||participants|||Number
1255429|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported|||ears|||Number
1255430|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.|||ears|||Number
1255431|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects that were randomized and had baseline and 12 month hearing exams were analyzed.|||ears|||Number
1255432|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported|||ears|||Number
1255433|NCT00466817|Secondary|Change in Best Ear Hearing Assessments at 24 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods|||participants|||Number
1255472|NCT00466206|Primary|Damage/Discoloration to Skin|Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear|One-month post-explant|Per protocol|||participants|||Number
1255434|NCT00466817|Secondary|Change in Best Ear Hearing Assessments at 12 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods|||participants|||Number
1255435|NCT00466817|Secondary|Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.|Adverse events were assessed at each visit through month 7 of the study. No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event.|baseline through 7 months||||participants|||Number
1255436|NCT00466817|Primary|Change in Best Ear Hearing Assessments at 6 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported|||participants|||Number
1255437|NCT00466752|Secondary|Number of Participants With at Least 25% Reduction in PSA|Proportion of Patients with at least 25% decline in PSA on Day 1 of Cycle 2, Day 1 of Cycle 3, and on day of radical prostatectomy.|Day 1 of cycles 2 and 3 and on the day of radical prostatectomy. Each cycle is 2 weeks.|One patient did not have lab samples collected on day of radical prostatectomy.|||Participants|||Count of Participants
1255438|NCT00466752|Secondary|Number of Participants With Complete Pathologic Response|Proportion of Patients with at least 50% decline in PSA on Day 1 of Cycle 2, Day 1 of Cycle 3, and on day of radical prostatectomy.|Day 1 of cycles 2 and 3, and day of radical prostatectomy. Each cycle is 2 weeks.|One patient did not have lab samples collected on day of radical prostatectomy.|||Participants|||Count of Participants
1255439|NCT00466752|Primary|Efficacy as Assessed by Number of Patients With Changes Across Transcript Profiles by Microarray Analysis in Prostate Cancer Specimens, Specifically Those With Complete Pathologic Response.|Determined by changes across transcript profiles, by microarray analysis, in pre- versus post-treatment prostate cancer specimens (minimum 50 day time frame between these). Proportion of patients with complete pathologic response.|Pre- versus post-treatment|Data not collected||||||
1255440|NCT00466726|Secondary|Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations|A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation|At 9 months||||participants|||Number
1255441|NCT00466726|Secondary|Number of Patients With Undetectable Transcript at Any Time After Immunization||Up to 6 months||||participants|||Number
1255442|NCT00466726|Primary|Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level|Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)|At 6 and 9 months||||participants|||Number
1255443|NCT00466687|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Number of patients with worst-grade toxicity at each of five grades following National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.|Day 1 of each 28-day cycle for 6 cycles (168 days)|Patients who received the study drug and who experienced a toxicity. Eleven patients did not experience any toxicity and are therefore not included in the analyzed population for this outcome measure.|||participants|||Number
1255444|NCT00466687|Secondary|Progression-free Survival at 6 Months|Patients with Progression-free survival at 6 months|6 months|Those patients who were progression-free at 6 months from study entry. No date of progression was available for 7 patients|||participants|||Number
1255445|NCT00466687|Secondary|Time to Disease Progression.|Time from on study date to date of progression in months, if the progression happened in the patient. Disease progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions with reference to the smallest sum LD since treatment began or the appearance of one or more new lesions.|up to one year after off-study date|Patients with disease progression. Six patients were not available for determination to progression: no data (5) and toxicity (1).|||Months||Full Range|Median
1255447|NCT00466661|Secondary|Clinical Global Impression Scale Score|Higher values indicate worse outcomes; minimum value = 1, maximum value = 7|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||score on a scale||Standard Deviation|Mean
1255473|NCT00466206|Secondary|Patient Compliance|Compliance measured by average number of hours per day external device was worn by patient, as measured by the data sensor and logging device built into external prosthetic|18 months active Rx|Per protocol|||avg hours per day brace worn||Full Range|Mean
1255453|NCT00466661|Secondary|Percent Heavy Drinking Days|Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||percentage of days drinking||Standard Deviation|Mean
1255454|NCT00466661|Secondary|Percent Days Abstinent|Percentage of days in trial with no alcohol consumption|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||percentage of days in trial||Standard Deviation|Mean
1255455|NCT00466661|Primary|Time to First Drink (Days)|Number of days after randomization until consumption of first alcoholic beverage per self-report.|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||Days||95% Confidence Interval|Mean
1255456|NCT00466505|Secondary|Serum TGF-alpha: Treatment Cycle 2|Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 2|on-study week 9||||ng/mL||Standard Deviation|Mean
1255457|NCT00466505|Secondary|Urinary PGE-M : Treatment Cycle 2|Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 2|on-study week 9||||ng/mL||Standard Deviation|Mean
1255458|NCT00466505|Secondary|Serum TGF-alpha: Treatment Cycle 1|Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 1|on-study week 5||||ng/mL||Standard Deviation|Mean
1255459|NCT00466505|Secondary|Urinary PGE-M : Treatment Cycle 1|Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 1|on-study week 5||||ng/mL||Standard Deviation|Mean
1255460|NCT00466505|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death.|On study date to off study date in this study with median 9.76 months||||patients|||Number
1255461|NCT00466505|Secondary|One Year Survival Rate|Percent of patients who remain alive one year from on-study date|1 year from on-study date||||Percentage of participants||95% Confidence Interval|Number
1255462|NCT00466505|Secondary|Overall Survival|Median survival time in months, from on-study date to date of death|On study date to off study date in this study with median 9.76 months||||Months||Inter-Quartile Range|Median
1255463|NCT00466505|Secondary|Patient Response to Treatment|Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|On study date to off study date in this study with median 9.76 months||||participants|||Number
1255464|NCT00466505|Primary|Progression-free Survival (PFS)|Number of days from study enrollment to evidence of progressive disease radiographically, with progression defined under RECIST criteria as at least 20% increase in sum of longest diameter of target lesions|On study date to off study date in this study with median 9.76 months||||Days||Full Range|Median
1255465|NCT00466323|Primary|Family-Clinician Contact (Not Including Notes From FMPO Clinicians)|Chart review looking at the any clinician contact with veteran's family members|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.|||Number of Interactions||Standard Deviation|Mean
1255466|NCT00466323|Secondary|Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score|We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales. This sub score is Overcoming Stuckness.The MHRM sub scales range from 0-16, with a higher score indicating better recovery.|Within 6 month of the intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.|||units on a scale||Standard Deviation|Mean
1255467|NCT00466323|Secondary|Consumer's Recovery Rating - MHRM Total Score|We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales.The MHRM scales range from 0-120, with a higher score indicating better recovery.|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.|||Units on a Scale||Standard Deviation|Mean
1255468|NCT00466323|Primary|Family-Clinician Contact (Including Contact With FMPO Clinician)|Chart review looking at the any clinician contact with veteran's family members|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.|||Number of Interactions||Standard Deviation|Mean
1255469|NCT00466310|Primary|Total Plasmalogen Levels in the Lipid Profile|Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens.|Baseline|17 of the 31 available controls were age and BMI matched to the schizophrenia subjects.|||nmoles/gram||Standard Deviation|Mean
1255470|NCT00466206|Primary|Efficacy: Patient Recommendation of Treatment|"Based on patient response to one-year post-explantation QoL statement: I would recommend this treatment for pectus excavatum (sunken chest) to someone else with pectus excavatum. Ratings: 5-strongly agree; 4-agree; 3-unsure; 2-disagree; 1-strongly disagree"|One year post-explanation|Per protocol|||Scores on a scale||Standard Deviation|Mean
1255471|NCT00466206|Primary|Efficacy: Patient Satisfaction|Based on patient response to one-year post-explantation QoL questionnaire: How satisfied are you with the correction of your chest? Ratings: 5-very satisfied; 4-satisfied; 3-unsure; 2-dissatisfied; 1-very dissatisfied|One year post-explant|Per protocol|||Scores on a scale||Standard Deviation|Mean
1271034|NCT00352053|Secondary|Change From Baseline to Week 288 in CD4 Count||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method|||cells/mm^3||Inter-Quartile Range|Median
1255474|NCT00466206|Primary|Affect on Cardiac Activity|EKG performed prior to implantation, one month post-implantation, and after explanation to evaluate whether magnetic field near the heart adversely affects cardiac activity. Outcome measure describes number of patients who experienced adverse change in EKG.|One month post-explantation|Per protocol, this is a single-arm, pilot study of ten subjects.|||participants|||Number
1255475|NCT00466193|Secondary|Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment|Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment.|Weeks 1 to 4|Safety population: participants who took at least one dose of study medication post-randomization.|||units on a scale||95% Confidence Interval|Least Squares Mean
1255476|NCT00466193|Primary|Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment|Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||minutes||95% Confidence Interval|Least Squares Mean
1255477|NCT00466193|Secondary|Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline|Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo.|Weeks -1 to 0|Safety population: participants who took at least one dose of study medication post-randomization.|||units on a scale||95% Confidence Interval|Least Squares Mean
1255478|NCT00466193|Secondary|Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment|The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||percentage of participants|||Number
1255479|NCT00466193|Secondary|Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline|The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||percentage of participants|||Number
1255480|NCT00466193|Secondary|Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment|Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||percentage of participants|||Number
1255481|NCT00466193|Secondary|Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.|Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||percentage of participants|||Number
1255482|NCT00466193|Secondary|Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment|Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||minutes||95% Confidence Interval|Least Squares Mean
1255483|NCT00466193|Secondary|Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline|Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||minutes||95% Confidence Interval|Least Squares Mean
1255484|NCT00466193|Primary|Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline|Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||minutes||95% Confidence Interval|Least Squares Mean
1255485|NCT00466167|Secondary|Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)||baseline and week 18|Treated set (TS 1) population: defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication and were treated for 18 weeks (or had discontinued treatment prior to week 18). Data limited to visit 8 (or V11 in case of premature discontinuation before visit 8).|||participants|||Number
1255863|NCT00463385|Secondary|Change From Baseline in Hemoglobin Concentration for Non-Responders|Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment.|Baseline, Cycle 6 (168 days)|Intent-to-treat participants with no clinical response and available hemoglobin values at each time point.|||g/dL||Full Range|Median
1255486|NCT00466167|Secondary|Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18|Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for “no pain” to ten for “unbearable pain”.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1255487|NCT00466167|Secondary|Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks|ranging from 0 (worst case) to 100 (best case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1255488|NCT00466167|Secondary|Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks|Ranging from 0 (best case) to 156 (worst case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1255489|NCT00466167|Secondary|Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks|ranging from 0 (worst case) to 150 (best case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1255490|NCT00466167|Secondary|Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks|ranging from 0 (best case) to 63 (worst case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1255491|NCT00466167|Secondary|Change From Baseline in UPDRS IV Score After 18 Weeks|UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1255492|NCT00466167|Secondary|Change From Baseline in UPDRS III Score After 18 Weeks|UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1255493|NCT00466167|Secondary|Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period|UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1255494|NCT00466167|Secondary|Change From Baseline in UPDRS I Score After 18 Weeks|UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Inter-Quartile Range|Median
1255495|NCT00466167|Secondary|Response in Patient Global Impression (PGI-I)|PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)|after 18 weeks of treatment|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Participants|||Number
1255496|NCT00466167|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Responder|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)|after 18 weeks of treatment|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Participants|||Number
1255497|NCT00466167|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18|Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Percentage of on-time||Standard Error|Least Squares Mean
1255498|NCT00466167|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18|Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Percentage of on-time||Standard Error|Least Squares Mean
1255499|NCT00466167|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia at Week 18|Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Percentage of on-time without dyskinesia||Standard Error|Least Squares Mean
1255500|NCT00466167|Secondary|Change From Baseline in Percentage Off-time at Week 18|Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Percentage of off-time||Standard Error|Least Squares Mean
1255501|NCT00466167|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18|UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|baseline and week 18|Full analysis set (FAS 1) population = 507 patients FAS 1 defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication, were treated for 18 weeks (or had prematurely discontinued treatment prior to week 18) and provided baseline and any on-drug post-baseline efficacy assessment|||Percentage of change from baseline||Standard Error|Least Squares Mean
1255502|NCT00465998|Secondary|Delivery Within 24 Hours|Association between parity, HPD, cervical length, cervical angle, occiput posterior position, parity, BMI and the Hazard ratio of delivering within 24 hours was investigated using Cox regression analysis.|Time from induction to delivery|Hazard ratio was reported.|||Hazard ratio||95% Confidence Interval|Number
1255992|NCT00462605|Primary|Response (Complete and Partial Response) in Patients With Myeloid Disorders|Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. Cytogenetic responses were monitored in patients with abnormalities at baseline.|Up to 2 years||||Participants|||Count of Participants
1255503|NCT00465998|Primary|Vaginal Delivery in Induced Labors|The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head–perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum.|Time from induction of labor to delivery||||percentage of area under the ROC curve||95% Confidence Interval|Number
1255504|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III.||48 weeks after study start|Intention to treat (ITT) population.|||pg/mL||Standard Deviation|Mean
1255505|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II.||32 weeks after study start|Intention to treat (ITT) population.|||pg/mL||Standard Deviation|Mean
1255506|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I.||until Week 8|Intention to treat (ITT) population.|||pg/mL||Standard Deviation|Mean
1255507|NCT00465985|Primary|Number of Participants Who Experienced a Disease Flare in Part II|Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) > 30 mg/L and either a PGA > minimal, or PGA equal to minimal and > minimal SD.|32 weeks after study start||||Participants|||Number
1255508|NCT00465985|Secondary|Pharmacokinetics (CLD (L/d))|Assessed serum clearance of ACZ885.|48 weeks after study start|Patients in Part I and Part II who received at least one dose of ACZ885.|||L/day||Standard Deviation|Mean
1255509|NCT00465985|Secondary|Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.||Week 8 and Week 32|Intention to treat (ITT)population and LOCF.|||mg/L||Standard Deviation|Mean
1255510|NCT00465985|Secondary|Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)|"A 5-point scale was used for the Physician’s global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items:~skin disease (urticarial skin rash)~arthralgia~myalgia~headache/migraine~conjunctivitis~fatigue/malaise~other symptoms related to autoinflammatory syndrome~other symptoms not related to autoinflammatory syndrome"|32 weeks after study start||||Participants|||Number
1255511|NCT00465985|Secondary|Number of Participants With Treatment Response in Part I (After 8 Weeks)|Treatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by >30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA > 30 mg/L and either PGA > minimal or PGA = minimal and SD > minimal. Non-responders = no PR by Day 8 or no CR by Day 15.|8 weeks after study start||||Participants|||Number
1255512|NCT00465985|Primary|Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part)|Determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Data expressed as a percent of participants who had experienced a flare by the end of Part II.|32 weeks after study start||||percent of participants|||Number
1255513|NCT00465972|Secondary|Change in Piper Fatigue Scale at 3 Months|A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1255514|NCT00465972|Primary|Response: Change in Insomnia Severity Rating Scale at 3 Months.|Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.|Baseline and 3 months|This is the LOCF population|||units on a scale||Standard Deviation|Mean
1255515|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)|"As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied."|Baseline through 52 Weeks|At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.|||percentage of participants|||Number
1255516|NCT00465894|Secondary|Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)|Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.|Baseline through 52 weeks|At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.|||percentage of participants|||Number
1255517|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.|Baseline through 52 weeks|At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1255518|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.|Baseline through 52 weeks|At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1255519|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)|"As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied."|Baseline through 24 weeks|At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis.|||percentage of participants|||Number
1255520|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)|Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.|Baseline through 24 weeks|At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis.|||percentage of participants|||Number
1255521|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.|Baseline to 24 weeks|At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1255522|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.|Baseline to 24 weeks|At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1255523|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary|Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.|From baseline through 12 weeks of Intervention|25 patients in each group completed voiding diary at baseline. 21 patients completed the voiding diary at 12 weeks in the Tolterodine group (complete diary). 25 patients in the estradiol group completed diary at 12 weeks. Incomplete diaries were not included in our analysis.|||events||Standard Deviation|Mean
1255524|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|"This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied."|From baseline through 12 Weeks of Intervention|In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. For this outcome ONLY, 1 patient from each Group were not available to obtain the measurements from this questionnaire. Therefore the overall number of participants analyzed for this outcome is less than other outcomes. Please see Participant Flow.|||participants|||Number
1255525|NCT00465894|Secondary|Evaluate Subjective Patient Change in Irritative Urinary Symptoms|"Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse.~Frequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement."|From baseline through 12 Weeks of Intervention|In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. These participants left for reasons identified in the Participant Flow.|||participants|||Number
1255526|NCT00465894|Secondary|Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)|Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.|From baseline through 12 Weeks of Intervention|In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. These participants left for reasons identified in the Participant Flow.|||units on a scale||Standard Deviation|Mean
1255527|NCT00465894|Primary|Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.|From baseline through 12 Weeks of Intervention|A baseline measure was achieved for Group 1 with 30 patients and Group 2 with 28 patients. At the 12 week measurement period, we were unable to analyze 5 patients in Group 1 (leaving 25 patients) and unable to analyze 3 patients in Group 2 (leaving 25 patients). These participants left for reasons identified in the Participant Flow.|||units on a scale||Standard Deviation|Mean
1255528|NCT00465816|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
1255529|NCT00465816|Secondary|Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits||During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
1255530|NCT00465816|Secondary|Number of Subjects Reporting Any Rash|Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
1255531|NCT00465816|Secondary|Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses|Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
1255532|NCT00465816|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Up to 1 month after each vaccine dose|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
1255533|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group.|During a 4-day period (Days 0-3) after each vaccine dose and across doses|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet.|||Participants|||Count of Participants
1255534|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination|Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Twinrix were assessed.|||Participants|||Count of Participants
1255535|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination|Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 4-day period (Days 0-3) after Nimenrix vaccination|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Nimenrix were assessed.|||Participants|||Count of Participants
1255536|NCT00465816|Secondary|Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value|The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||Participants|||Count of Participants
1255537|NCT00465816|Secondary|IgG Anti-HBs Antibody Concentrations|Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||milli-Internatinal Units per Milliliter||95% Confidence Interval|Geometric Mean
1255538|NCT00465816|Secondary|Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value|The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||Participants|||Count of Participants
1255539|NCT00465816|Secondary|Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations|Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||milli-Internatinal Units per Milliliter||95% Confidence Interval|Geometric Mean
1255540|NCT00465816|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7|The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.|At 7 months after vaccination with Nimenrix (At Month 7)|The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.|||Participants|||Count of Participants
1255541|NCT00465816|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7|Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).|At 7 months after vaccination with Nimenrix (At Month 7)|The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1255542|NCT00465816|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7|The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.|At 7 months after vaccination with Nimenrix (At Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Participants|||Count of Participants
1255993|NCT00462501|Primary|Complete Pathologic Response|This will be assessed on the basis of the surgical pathology report.|3 years||||participants|||Number
1255543|NCT00465816|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7|The rSBA titers were expressed as geometric mean titers.|At 7 months after vaccination with Nimenrix (At Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1255544|NCT00465816|Secondary|Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value|The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Participants|||Count of Participants
1255545|NCT00465816|Secondary|Anti-Tetanus Toxoid (TT) Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||International Units per milliliter||95% Confidence Interval|Geometric Mean
1255546|NCT00465816|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values|The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.|||Participants|||Count of Participants
1255547|NCT00465816|Secondary|Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1255548|NCT00465816|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values|The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Participants|||Count of Participants
1255549|NCT00465816|Secondary|Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135|Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].|At 1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Participants|||Count of Participants
1255550|NCT00465816|Primary|Number of Subjects Seroprotected for Hepatitis B|A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).|At 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||Participants|||Count of Participants
1255551|NCT00465816|Primary|Number of Subjects Seroconverted for Hepatitis A|A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.|At 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on initially seronegative subjects in those groups that received the Twinrix vaccine.|||Participants|||Count of Participants
1255552|NCT00465816|Primary|Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers|The rSBA titers were expressed as geometric mean titers (GMTs).|At 1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1255553|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255994|NCT00462462|Secondary|Patient Benefit||study end|||||||
1255554|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255555|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255556|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255557|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255558|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255559|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255560|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255561|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255584|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255562|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255563|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255564|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255565|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255566|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255567|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255568|NCT00465738|Secondary|Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set|The patient’s global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.|week 4|Full Analysis Set|||units on a scale||Standard Error|Mean
1255569|NCT00465738|Secondary|Investigator’s Global Assessment of Treatment Response (GATR) - Full Analysis Set|The investigator’s global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||units on a scale||Standard Error|Mean
1255570|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||degree||Standard Error|Mean
1288234|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24||Month 24||||L||Standard Error|Mean
1255571|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||degree||Standard Error|Mean
1255572|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||degree||Standard Error|Mean
1255573|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||degree||Standard Error|Mean
1255574|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255575|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255576|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255577|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255578|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255579|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255580|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255581|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255582|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255583|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255995|NCT00462462|Secondary|Change in Volume of Congenital Venous Malformation (CVM) From Screening to Study End (Day 112 Visit).||Screening and study end (Day 112)||||cm3||Standard Deviation|Mean
1255585|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255586|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255587|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255588|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a “catch” when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255589|NCT00465738|Secondary|Responder in FAT at Follow up - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255590|NCT00465738|Secondary|Responder in FAT at Week 12 - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|Week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255591|NCT00465738|Secondary|Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|Week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255592|NCT00465738|Secondary|Responder in DAS at Follow up - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255593|NCT00465738|Secondary|Responder in DAS at Week 12 - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255594|NCT00465738|Secondary|Responder in DAS at Week 4 - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
1255595|NCT00465738|Primary|Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set|The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.|At week 4|Analysis is based on Per Protocol Set, defined as all randomized subjects who received at least one dose of study drug and who have no major deviation from study protocol. For this set of subjects no missing values can occur for the primary endpoint.|||participants|||Number
1255596|NCT00465647|Secondary|Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time|"The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = no pain and 10 = most pain, was used by children ≥ 12 years of age."|Immediately prior to first oral dose, up to 54 hours|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).|||unit on a scale||Standard Error|Mean
1255678|NCT00464698|Secondary|QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17)|"Quality of life, such that lower score reflects poorer quality of life~Minimum score: 16 Maximum score: 80"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.|||units on a self-report questionnaire||Standard Deviation|Mean
1255996|NCT00462462|Secondary|Systemic (Cardiopulmonary, Hematological, Metabolic) and Local Outcome of the Two Test Products.||Study end|||||||
1255597|NCT00465647|Secondary|Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time|Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions. Each face is 25 x 35 mm with 13 mm between faces. Each subject was asked to point to the face that reflected his or her pain. The end points are 0 = no pain and 10 = very much pain. The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.|Immediately prior to first oral dose with potentially up to 54 hours duration.|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).|||units on a scale||Standard Error|Mean
1255598|NCT00465647|Secondary|Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]|There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability. Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10. The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.|Immediately prior to first oral dose, up to 54 hours|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).|||units on a scale||Standard Error|Mean
1255599|NCT00465647|Primary|Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)|"Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study.~Efficacy was based on Oral treatment only."|A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.|The full analysis population for Pharmacokinetics/ Pharmacodynamics consisted of subjects who received at least 1 dose of oral hydromorphone HCl, and had at least 1 valid quantifiable PK sample. To be a valid sample, the time of administration of each dose of oral hydromorphone HCl, the dose, and the time of sample collection must be recorded.|||L/hour||95% Confidence Interval|Number
1255600|NCT00465595|Primary|HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).|"The Hamilton Anxiety Rating Scale is a 14-item clinician-administered rating scale designed to assess severity of anxiety symptoms. The score range for the HAM-A is 0 to 56, with higher score indicating more severe anxiety.~For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAM-A"|Baseline, 5 weeks post session 1 and 2, 6-month follow-up||||units on a scale||Standard Error|Mean
1255601|NCT00465595|Primary|GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.|The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD|Baseline, 5 weeks post session 1 and 2, 6-month follow-up||||units on a scale||Standard Error|Mean
1255602|NCT00465569|Secondary|Changes in Cow Milk Immunoglobulin G4 (IgG4)|IgG4 is measured in ug/mL. Measurements were obtained at Baseline and at 23 weeks|Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation|||percentage of change||Full Range|Median
1255603|NCT00465569|Secondary|Changes in Cow Milk-IgE|IgE is measured in kilounits per liter (kU/L). Measurements were obtained at Baseline and at 23 weeks|Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation|||percentage of change||Full Range|Median
1255604|NCT00465569|Primary|The Median Milk Threshold Dose Inducing a Reaction||Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation. The median milk threshold dose in both groups was 40 with a full range of 40-1340 at the baseline challenge.|||miligrams||Full Range|Median
1255605|NCT00465530|Primary|Change in Overall Quality of Life|Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.|3 Weeks to Follow-Up (7 Weeks)||||units on a scale||Standard Deviation|Mean
1255606|NCT00465530|Secondary|Change in Overall Quality of Life|Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.|Baseline to 3 Weeks||||units on a scale||Standard Deviation|Mean
1255607|NCT00465530|Primary|Change in Computed Tomography (CT) Score After Treatment|Change in CT score reflects the Lund-Mackay staging system. Each sinus is scored separately and scores are determined for the right and the left side. The lowest score of 0 represents no opacification in the sinus. A score of 1 represents a partial opacification. A score of 2 represents complete opacification.|Change from Baseline to 6 Weeks||||units on a scale||Standard Deviation|Mean
1255608|NCT00465361|Primary|Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit|Residents were observed to determine whether specific aspects of infant developmental status, as part of developmental surveillance, were assessed during the two-month preventive care visit. The components of developmental surveillance observed were: assessment of the infant's ability to follow past midline, assessment of the infant's ability to lift his/her head off of the table in prone, assessment of the infant's ability to hold an object placed in his/her hand, assessment of the infant's ability to coo, and assessment of the infant's ability to demonstrate a social smile.|Residents were observed during each of the eligible preventive care visits. Each visit was an average of 20 minutes in length. Preventive care visits were observed over a 13 month time period.||||Participants|||Number
1255609|NCT00465270|Post-Hoc|Rate of Recurrent Nonfatal Stroke, Post-randomization Death, and Fatal Ischemic Stroke Through Long Term Follow-up||Long Term Follow-up, median of 5.9 years||||Participants|||Count of Participants
1255610|NCT00465270|Secondary|Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group||6 months|Only subjects with complete PFO closure data at 6-months were analyzed.|||Participants|||Count of Participants
1255611|NCT00465270|Primary|Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization|"Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct.~Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last."|Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.|All primary endpoints that occurred in the trial were recurrent non-fatal ischemic strokes.|||Participants|||Count of Participants
1255612|NCT00465179|Secondary|Median Overall Survival|Overall survival was estimated using the Kaplan-Meier method.|Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years.||||months||95% Confidence Interval|Median
1255613|NCT00465179|Primary|Median Progression-Free Survival (PFS)|Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.|Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years|Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.|||months||95% Confidence Interval|Median
1255614|NCT00465179|Primary|Number of Participants With Response to Treatment|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years|Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.|||participants|||Number
1255615|NCT00465101|Secondary|Occurrence of Retrograde Ejaculation|Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.|5 Year Follow Up|Participants who received the study treatment|||percentage of subjects with RE||95% Confidence Interval|Number
1255616|NCT00465101|Other Pre-specified|Total Joules Used|Total energy applied during the study procedure|Procedure|Participants who received the study treatment and for whom the outcome measure is available.|||kilojoules (kJ)||Standard Deviation|Mean
1255617|NCT00465101|Other Pre-specified|Number of Fibers Used During Procedure||Procedure|Participants who received the study treatment and for whom the outcome is available.|||number of fibers used||Standard Deviation|Mean
1255618|NCT00465101|Other Pre-specified|Length of Lasing (LOL)|Total time the laser was on during the study procedure.|Procedure|Participants who received the study treatment and for whom the outcome measure is available.|||minutes||Standard Deviation|Mean
1255619|NCT00465101|Other Pre-specified|Length of Procedure (LOP)|Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).|Procedure|Participants who received the study treatment and for whom the outcome measure is available.|||minutes||Standard Deviation|Mean
1255620|NCT00465101|Other Pre-specified|Length of Catheterization (LOC)|Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).|Recovery Period|Participants who received the study treatment and for whom the outcome measure is available.|||hours||Standard Deviation|Mean
1255621|NCT00465101|Other Pre-specified|Length of Hospital Stay (LOS)|Defined as the time from admission to the healthcare facility until discharge (in hours).|Peri-Operative Period|Participants who received the study treatment and for whom the outcome measure is available.|||hours||Standard Deviation|Mean
1255622|NCT00465101|Secondary|Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.||Up to five years|Participants who received the study treatment and for whom the outcome measure is available.|||days||Standard Deviation|Mean
1255623|NCT00465101|Secondary|Percentage of Participants With Treatment Success|Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.|5 Years|Participants who received the study treatment and for whom the outcome measure is available.|||Percent of subjects w/ treatment success||95% Confidence Interval|Number
1255624|NCT00465101|Secondary|Gross Hematuria|Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.|91 days|Participants who received the study treatment|||Percentage of subjects|||Number
1255625|NCT00465101|Secondary|Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.|"Participant response to the question If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Values range from 0 (Delighted) to 6 (Terrible) with higher values indicating worse outcomes."|5 years|Participants who received the study treatment and for whom the outcome measure is available.|||Score on a scale||Standard Deviation|Mean
1255626|NCT00465101|Secondary|Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.|A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.|6 months post-treatment|Participants who received the study treatment and for whom the outcome measure is available.|||percentage of patients improved||95% Confidence Interval|Number
1255627|NCT00465101|Secondary|Percentage of Participants With Clinically-significant Improvement in Uroflow.|A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months|6 months post-treatment|Participants who received the study treatment and for whom the outcome measure is available.|||percentage of patients improved||95% Confidence Interval|Number
1257565|NCT00450866|Secondary|Overall Survival|Median time (months) that patients survived during the duration of the study.|48 months from start of study|Intention to treat|||months||95% Confidence Interval|Median
1255628|NCT00465101|Secondary|Treatment-related Complication|"Treatment-related events include the following:~Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization~Perforation / injury of adjacent organ(s)~Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal~Hematuria requiring transfusion~Urinary retention requiring corrective intervention~De novo erectile dysfuction (ED)~Transfusion secondary to procedure-related anemia~Post procedure incontinence secondary to damage to the external urinary sphincter~Any other treatment-related injury requiring intervention"|3 months|Participants who received the study treatment.|||percentage of subjects with complication||95% Confidence Interval|Number
1255629|NCT00465101|Primary|Percentage of Participants With Treatment Success|Treatment success is determined on a per patient basis and is defined as [(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS] greater than or equal to 50%|6 months|Participants who received the study treatment and for whom the outcome measure is available.|||percentage of participants|||Number
1255630|NCT00465088|Secondary|Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12|NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.|12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline value for all 3 lipid parameters|||Percentage of subjects|||Number
1255631|NCT00465088|Secondary|Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12||12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline triglyceride value|||Percentage of subjects|||Number
1255632|NCT00465088|Secondary|Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12|For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.|12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline LDL-C value|||Percentage of subjects|||Number
1255633|NCT00465088|Secondary|Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12||12 weeks|All treated subjects not meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III goals at baseline with both a baseline and at least 1 postbaseline HDL-C value|||Percentage of subjects|||Number
1255634|NCT00465088|Secondary|Percent Change in Lipoprotein A From Baseline to Week 12|(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||Inter-Quartile Range|Median
1255635|NCT00465088|Secondary|Percent Change in Total Cholesterol:HDL-C Ratio|(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio|From baseline to Week 12|All treated subjects whose Week 12 values were obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
1255636|NCT00465088|Secondary|Percent Change in Total Cholesterol From Baseline to Week 12|(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
1255637|NCT00465088|Secondary|Percent Change in LDL-C:HDL-C Ratio|(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio|From baseline to Week 12|All treated subjects whose Week 12 values were obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
1255638|NCT00465088|Secondary|Percent Change in Triglycerides From Baseline to Week 12|(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||Inter-Quartile Range|Median
1255639|NCT00465088|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12|(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window (between 70 days after first dose and not more than 3 days after last dose)|||percent change||95% Confidence Interval|Least Squares Mean
1255640|NCT00465088|Secondary|Percent Change in Non-HDL-C From Baseline to Week 12|(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
1255641|NCT00465088|Secondary|Percent Change in Non-HDL-C From Baseline to Week 8|(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C|From baseline to Week 8|All treated subjects whose Week 8 value was obtained within the Week 8 visit window|||percent change||95% Confidence Interval|Least Squares Mean
1255642|NCT00465088|Secondary|Percent Change in HDL-C From Baseline to Week 8|(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C|From baseline to Week 8|All treated subjects whose Week 8 value was obtained within the Week 8 visit window|||percent change||95% Confidence Interval|Least Squares Mean
1255643|NCT00465088|Primary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12|(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
1255644|NCT00464945|Primary|Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series|Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population were participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1271035|NCT00352053|Secondary|Change From Baseline to Week 240 in CD4 Count||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method|||cells/mm^3||Inter-Quartile Range|Median
1255645|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after toddler dose|The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1255646|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants (268) who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1255647|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1255648|NCT00464945|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1255649|NCT00464815|Secondary|Number of Subjects With Specific Adverse Events|These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).|Up to study end (Month 6)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1255650|NCT00464815|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to study end (Month 6)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1255651|NCT00464815|Secondary|Number of Subjects With Any Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1255652|NCT00464815|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.|During the 4-day (Days 0-3) period after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
1255653|NCT00464815|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).|During the 4-day (Days 0-3) period after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
1255654|NCT00464815|Secondary|Anti-meningococcal Polysaccharide Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||μg/mL||95% Confidence Interval|Geometric Mean
1255679|NCT00464698|Secondary|BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17)|"Anxiety severity, such that a higher score on the BAI reflects more severe anxiety.~Minimum value: 0 Maximum value: 63"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.|||units on a self-report questionnaire||Standard Deviation|Mean
1271036|NCT00352053|Secondary|Change From Baseline to Week 192 in CD4 Count||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method|||cells/mm^3||Inter-Quartile Range|Median
1255655|NCT00464815|Secondary|Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values|The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
1255656|NCT00464815|Secondary|Anti-TT Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||IU/mL||95% Confidence Interval|Geometric Mean
1255657|NCT00464815|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value|The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
1255658|NCT00464815|Secondary|Meningococcal rSBA Antibody Titers|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Titer||95% Confidence Interval|Geometric Mean
1255659|NCT00464815|Secondary|Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values|Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
1255660|NCT00464815|Primary|Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms|General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).|During the 4-day (Days 0-3) period after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1255661|NCT00464815|Primary|Number of Subjects With Vaccine Response to Meningococcal Antigens|Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].|One month post-vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
1255662|NCT00464737|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 50, 33 and 22 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.|||score on a scale||Standard Deviation|Mean
1255663|NCT00464737|Secondary|Number of Subjects With Presence of Impulse Control Disorders|Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).|12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
1255664|NCT00464737|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase|The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
1255665|NCT00464737|Secondary|Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase|All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
1255666|NCT00464737|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase|The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
1255667|NCT00464737|Secondary|Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12||End of the Maintenance Phase/Week 12|The number of patients in the Placebo group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 73 (Rotigotine 4 mg) and 74 (Rotigotine 8 mg) patients respectively in the Safety Set, a total of 41 and 20 patients respectively at the end of Maintenance Phase/Week 12 have this assessment.|||ug/ML||Standard Deviation|Mean
1255668|NCT00464737|Secondary|Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase|Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.|12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
1255669|NCT00464737|Secondary|Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1255670|NCT00464737|Secondary|Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase|The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).|Baseline, Last assessment in the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 76, 58, and 51 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Patients|||Number
1255671|NCT00464737|Secondary|Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase|General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1255672|NCT00464737|Secondary|Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase|Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1255673|NCT00464737|Secondary|Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase|Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
1255674|NCT00464737|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase|The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia|Baseline, Last assessment in the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 80, 64 and 63 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Score on a scale||Standard Deviation|Mean
1255675|NCT00464737|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1255676|NCT00464711|Primary|Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores|"The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as > 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score < 8.~40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks."|12 weeks|40 patients (21 female) with MDD enrolled in the 12 week study, 25 patients (15 Female) completed. Current analyses are based on completers only.|||participants|||Number
1255677|NCT00464698|Secondary|Clinical Global Impressions Scale at Week 3 and Week 17|"Global severity of illness, such that a higher score reflects worse global severity~Minimum score: 2 Maximum score: 14"|Week 3 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.|||units on a self-report questionnaire||Standard Deviation|Mean
1288235|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24||Month 24||||L||Standard Error|Mean
1255680|NCT00464698|Secondary|BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17).|"Depression severity, such that higher scores on the BDI are reflective of more severe depression.~BDI minimum score: 0 MDI maximum score: 63"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.|||units on a self-report questionnaire||Standard Deviation|Mean
1255681|NCT00464698|Primary|Y-BOCS Scores at 1st and Last Visit|OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.|Week 0 to 17||||units on a scale||Standard Deviation|Mean
1255682|NCT00464685|Secondary|Time to Retreatment in the Study Eye|Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.|12 Months|Intent to Treat: all randomized patients|||Days||95% Confidence Interval|Median
1255683|NCT00464685|Secondary|Change From Baseline in the Focal Leakage Area in the Study Eye|Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 12|Intent to Treat: all randomized patients|||Millimeters Squared (mm^2)||Standard Deviation|Mean
1255684|NCT00464685|Secondary|Change From Baseline in Central Subfield Retinal Thickness in the Study Eye|Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients|||Microns||Standard Deviation|Mean
1255685|NCT00464685|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients|||Letters Read Correctly||Standard Deviation|Mean
1255686|NCT00464685|Primary|Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1255687|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age|Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.|21 days after vaccination|The analysis was done on the per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1255688|NCT00464672|Secondary|Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.|Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.|7 days after each vaccination|The analysis was performed on the safety population.|||Participants|||Number
1255689|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age|To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per-protocol (PP)population.|||Titers||95% Confidence Interval|Geometric Mean
1255690|NCT00464672|Secondary|Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Mean
1255691|NCT00464672|Secondary|Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age|To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per-protocol (PP) population|||Percentage of participants||95% Confidence Interval|Mean
1255692|NCT00464672|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age|Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.|7 days after vaccination|The analysis was performed on the safety population.|||Participants|||Number
1255693|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age|To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP)population|||Titers||95% Confidence Interval|Geometric Mean
1255694|NCT00464672|Secondary|Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP)population.|||Percentage of participants||95% Confidence Interval|Mean
1255734|NCT00464568|Secondary|Mean Forced Expiratory Volume in One Second (FEV1)|The FEV1 is the volume of air forcefully exhaled in 1 second. The highest FEV1 value amongst the three recorded FEV1 readings was used for all FEV1 calculations. FEV1 was recorded pre-dose and at follow-up.|Up to 9 weeks|All subjects population.|||Liters (L)||Standard Deviation|Mean
1255695|NCT00464672|Secondary|Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age|To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Mean
1255696|NCT00464672|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age|Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.|7 days after vaccination|The analysis was performed on the safety population.|||participants|||Number
1255697|NCT00464672|Primary|Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Mean
1255698|NCT00464672|Primary|Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age|To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of participants||95% Confidence Interval|Mean
1255699|NCT00464646|Secondary|Percentage of Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)||2-4 weeks after surgery and at 9 and 12 months from study entry|||||||
1255700|NCT00464646|Secondary|Overall Survival||From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entry|||||||
1255701|NCT00464646|Secondary|Recurrence-free Survival||From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entry|||||||
1255702|NCT00464646|Secondary|Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)||Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entry|||||||
1255703|NCT00464646|Secondary|Clinical Complete Response (cCR)||Determined at baseline, between EC and docetaxel, and following docetaxel (before surgery)|||||||
1255704|NCT00464646|Secondary|pCR in the Breast (Cohort A)||Assessed at the time of surgery|||||||
1255705|NCT00464646|Primary|Cardiac Event Rate as Determined by LVEF Assessment||Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.|||||||
1255706|NCT00464646|Primary|Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)|The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.|Assessed at time of surgery on average at 8 months|73 of the 76 patients in Cohort A were analyzed: 2 patients did not have surgery and 1 patient did not have the nodal status determined.|||participants|||Number
1255707|NCT00464620|Secondary|Number of Participants With Tumors With Mutations in Kinases|Obtain tumor tissue to examine the frequency of mutations in kinases such as PDGFR in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing’s, ASPS, chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the tissue that was able to generate tissue microarray for PDGFR analysis.|Up to 37 weeks|The overall number of participants analyzed demonstrates the number of participants whose tumor samples were received. The results illustrate the tissue that was able to generate tissue microarray for PDGFR analysis.|||Participants|||Count of Participants
1255708|NCT00464620|Secondary|Number of Participants With Tumors With Kinase Expression|Obtain tumor tissue for creation of tissue microarrays to examine the frequency of kinase expression such as SRC and/or FAK in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing’s, Alveolar soft part sarcoma (ASPS), chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma, and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the number of participants who had tissue that was able to generate tissue microarray for kinase expression.|Up to 37 weeks|The overall number of participants analyzed demonstrates the number of participants whose tumor samples received. The results illustrate the tissue that was able to generate tissue microarray for SRC and FAK analysis.|||Participants|||Count of Participants
1255709|NCT00464620|Secondary|Plasma Level of Dasatinib and Inhibition of SRC and/or Focal Adhesion Kinase (FAK) in Peripheral Blood Mononuclear Cells|Obtain blood samples to characterize plasma level of dasatinib and inhibition of SRC and/or FAK in peripheral blood mononuclear cells 2 hours after ingestion of drug at 2-4 weeks from the start of treatment if activity of the drug in a sarcoma subtype warrants further study.|2-4 weeks from start of treatment|Evaluation of blood levels of drug was not performed because there was insufficient activity and the level of activity did not warrant further study.||||||
1255710|NCT00464620|Secondary|Uni-dimensional and Bi-dimensional Tumor Size, Tumor Volumes and Tumor Average Density Determined by Computer-aided Automated Detection in a Subset of Subjects With Tumor Predominately Involving the Lung|To prospectively collect uni-dimensional and bi-dimensional tumor size, tumor volumes and tumor average density determined by computer-aided automated detection in a subset of subjects with tumor predominately involving the lung|Up to 37 weeks|This data was not collected because the imaging software and work station was not obtained.||||||
1255711|NCT00464620|Secondary|Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.|To estimate the overall survival rates at 2 and 5 years from registration of subjects enrolled in the aggressive subtype treated with dasatinib.|At 2 and 5 years|The number analyzed in one or more rows differs from overall number because the rows are broken down into cohorts. The counts in the categories will not add up to the number analyzed, because those numbers represent number of participants that have reached overall survival at 2 and 5 years.|||participants|||Number
1255712|NCT00464620|Secondary|Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.|To estimate the median time-to-progression of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, MFH, rhabdomyosarcoma and MPNST treated with dasatinib.|Up to 37 weeks||||months||Full Range|Median
1255713|NCT00464620|Secondary|6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.|To estimate the 6 month progression-free survival rate of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, Malignant fibrous histiocytoma (MFH), rhabdomyosarcoma and MPNST treated with dasatinib.|At 6 months|The numbers analyzed in one or more rows are different because they are broken up by cohorts.|||Participants|||Count of Participants
1255714|NCT00464620|Secondary|"Median Time-to-progression of Subjects With Indolent Sarcomas Treated With Dasatinib."|"To estimate the median time-to-progression of subjects with indolent sarcomas treated with dasatinib."|Up to 24 months||||months||Full Range|Median
1255715|NCT00464620|Secondary|Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.|To estimate the overall survival rates at 2 and 5 years from registration of subjects treated with dasatinib.|At 2 and 5 years||||Participants|||Count of Participants
1255716|NCT00464620|Secondary|Median Time-to-progression of Subjects With GIST Treated With Dasatinib.|To estimate the median time-to-progression of subjects with GIST treated with dasatinib.|Up to 30 months||||months||Full Range|Median
1255717|NCT00464620|Primary|6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)|To estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.|6 months||||Participants|||Count of Participants
1255718|NCT00464620|Primary|"6 Month Progression-free Survival Rate of Indolent Sarcomas Treated With Dasatinib"|"Estimate the 6 month progression-free survival rate of indolent sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass."|At 6 months||||Participants|||Count of Participants
1255719|NCT00464620|Primary|Response Rate: Number of Participants With Objective Tumor Response|Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.|Up to 24 months|116 subjects enrolled in the Indolent subtype, however 109 subjects began treatment. 50 patients enrolled in the GIST subtype, however 48 patients were evaluable. This explains the discrepancy between Overall Number of Participants Analyzed.|||Participants|||Count of Participants
1255720|NCT00464568|Secondary|Mean Levels of Total Vasodilator Stimulated Phosphoprotein (VASP) Protein, Phosphorylated(Phospho)157 VASP (pVASP) and phospho239 VASP in Lavage Cells|Nasal lavage were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal lavage samples were analyzed to explore the effects of GSK256066 on novel protein biomarkers including pVASP. Markers indicative of PDE4 inhibition such as VASP protein levels and phospho157 VASP were also measured in this study, in lavage cells, following positive data in an enabling study which showed increases in such protein levels in participants with allergic rhinitis following a single intranasal dose of salbutamol. Nasal lavage data from earlier studies showed that pVASP157 is the best marker and not pVASP239. pVASP239 was therefore not collected or analyzed as planned.|Day 1|All subjects population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Deviation|Mean
1255721|NCT00464568|Secondary|Nasal Lavage Concentrations of GSK256066|Nasal lavage samples were taken 2 -3 hour post morning dose and analyzed for GSK256066. Quantifiable levels of GSK256066 were observed in nasal lavage samples obtained 2-3 hours post-dose.|Day 1|PK concentration population.|||Picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1255722|NCT00464568|Secondary|Tmax and Tlast of Active Metabolite GSK614917|The PK of GSK614917 were assessed in plasma by determining Tmax and Tlast. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Tmax and Tlast could not be determined for any participant at the 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population.|||Hour||Full Range|Median
1255723|NCT00464568|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax) and Time to Last Observed Plasma Drug Concentration (Tlast) of GSK256066|The PK of GSK256066 were assessed in plasma by determining Tmax and Tlast. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.|Pre -dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK Parameter population. Only those participants with data available at the indicated time points were analyzed.|||Hour||Full Range|Median
1255794|NCT00464204|Secondary|Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization|Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization|until hemodynamic stabilization (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Hours||Standard Deviation|Mean
1255724|NCT00464568|Secondary|Cmax of Active Metabolite GSK614917|The PK of GSK614917 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. C max was not calculable for any participant at the 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population. Only those participants with data available at the indicated time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1255725|NCT00464568|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) of GSK256066|The PK of GSK256066 were assessed in plasma by determining Cmax. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK Parameter population. Only those participants with data available at the indicated time points were analyzed.|||Picogram per mililiter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1255726|NCT00464568|Secondary|AUC (0-last) of Active Metabolite GSK614917|The PK of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. AUC (0-last) was not calculable in any participant at the 1, 10 or 50 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population. Only those participants with data available at the indicated time points were analyzed.|||pg * hr/mL||Geometric Coefficient of Variation|Geometric Mean
1255727|NCT00464568|Secondary|Area Under the Plasma Drug Concentration Versus Time Curve (AUC0-last) of GSK256066|The pharmacokinetics (PK) of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the active investigational product provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066. AUC (0-last) was not calculable for any participant at 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population comprised of all participants from the PK Concentration population (comprised of all participants from the All Subjects population for whom blood or nasal samples were taken for assaying study drug) for whom PK parameters were available. Only those participants with data available at the indicated time points were analyzed.|||Picogram*hour per milliliter (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1255728|NCT00464568|Secondary|Number of Participants With Clinical Chemistry Values of Potential Clinical Concern|Blood samples for clinical chemistry were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with clinical chemistry values of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for total bilirubin levels (clinical concern upper value: >31 micromole/liter) and inorganic phosphorus level (normal range: 0.7-1.5 millimole/liter).|Up to 9 weeks|All subjects population.|||Participants|||Number
1255729|NCT00464568|Secondary|Number of Participants With Hematology Values of Potential Clinical Concern|Blood samples for hematology were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with hematology of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for white blood cell count (clinical concern range: 3 to 20 giga cells/liter), neutrophils (normal range: 2.1 to 10.0 giga cells/liter), hemoglobin (clinical concern upper value: >180 grams/liter). Only those parameters for which at least one value of potential clinical concern was reported are summarized.|Up to 9 weeks|All subjects population.|||Participants|||Number
1255730|NCT00464568|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 9 weeks|All subjects population.|||Participants|||Number
1255731|NCT00464568|Secondary|Change From Baseline in Electrocardiogram (ECG) Values|Electrocardiogram variables evaluated included PR interval, QRS duration, QT interval, QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) and RR interval. ECG was performed pre-dose, one hour and four hour post-dose. The ECG measurements were made with the participant in a supine position having rested in this position for at least 10 minutes before each time-point. Baseline was defined as the pre-dose measurement on Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values|Baseline (Day 1) to 9 weeks|All subjects population.|||Millisecond (msec)||Standard Deviation|Mean
1255732|NCT00464568|Secondary|Mean Heart Rate Over Study Period|Vital signs included heart rate. Heart rate was measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.|Up to 9 weeks|All subjects population.|||Beats/minute||Standard Deviation|Mean
1255733|NCT00464568|Secondary|Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Over Study Period|Vital signs included SBP and DBP. SBP and DBP were measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.|Up to 9 weeks|All subjects population.|||Millimetres of mercury (mmHg)||Standard Deviation|Mean
1255811|NCT00463801|Secondary|Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)||at day 14 and follow up day i.e. day 30|||||||
1255735|NCT00464568|Primary|Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression|The effect of GSK256066 on ribonucleic acid (RNA) levels indicative of Phosphodiesterase-4 (PDE4) inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples was evaluated. Nasal lavage and scrapes were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal scrape samples were taken from alternate nostrils. The novel RNA markers presented are cAMP responsive element modulator (CREM), dual specificity phosphatase 1(DUSP1), fos-like antigen 2(FOSL2), insulin receptor substrate 2 (IRS2), nuclear receptor subfamily 4, group A, member 2 (NR4A2), Phosphodiesterase-4A (PDE4A), Regulator of G-protein signalling 1 (RGS1), Serine/threonine protein kinase SNF1 like kinase (SNF1LK). Nasal lavage cytospins were stained with a SNF1LK specific monoclonal antibody by indirect immunofluorescence. Adjusted Geometric Mean and Standard error logs are presented.|Day 1|All Subjects population comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).|||COPIES/50 nanogram (NG)||Standard Error|Geometric Mean
1255736|NCT00464542|Secondary|Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy|The time by which half of the participants were diagnosed with bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy|30 days after cessation of metronidazole therapy||||Days||Full Range|Median
1255737|NCT00464542|Primary|Number of Participants With Bacterial Vaginosis Recurrence|Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.|30 days after cessation of metronidazole therapy|per protocol|||Participants|||Number
1255738|NCT00464490|Primary|Mechanical Ventilation Time||time from first weaning attempt to successful extubation||||hours||Standard Deviation|Mean
1255739|NCT00464464|Primary|Hamilton Depression Rating Scale: Follow-Up Evaluation|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, 4 weeks after the trial ended.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|14 weeks||||units on a scale||Standard Deviation|Mean
1255740|NCT00464464|Primary|Hamilton Depression Rating Scale: Endpoint|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the end of the 10 week trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|10 weeks||||units on a scale||Standard Deviation|Mean
1255741|NCT00464464|Primary|Hamilton Depression Rating Scale: Midpoint|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, after 5 weeks of the trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|5 weeks||||units on a scale||Standard Deviation|Mean
1255742|NCT00464464|Primary|Hamilton Depression Rating Scale: Baseline|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the outset of the trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|0 weeks||||units on a scale||Standard Deviation|Mean
1255743|NCT00464438|Secondary|Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7|"Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,~+3=severe)."|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"|||Percentage of Patients|||Number
1255744|NCT00464438|Secondary|Percentage of Patients With Improvement in Ocular Signs for Lid Erythema|Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Days 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"|||Percentage of Patients|||Number
1255745|NCT00464438|Secondary|Percentage of Patients With Microbiological Improvement|Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"|||Percentage of Patients|||Number
1255746|NCT00464438|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7|Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria."|||Percentage of Patients|||Number
1255812|NCT00463801|Secondary|Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE||At day 14|||||||
1255813|NCT00463801|Secondary|Efficacy Assessed by Time of Resolution of Infection|Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).|At day 14|||||||
1255747|NCT00464334|Primary|Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies|The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.|Baseline and Month 7|Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.|||fold change||95% Confidence Interval|Geometric Mean
1255748|NCT00464334|Primary|Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7|The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).|Month 7|Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.|||ng/mL||95% Confidence Interval|Geometric Mean
1255749|NCT00464334|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 6 months after first dose of vaccine|Population consists of all participants who received at least one dose of vaccine.|||participants|||Number
1255750|NCT00464334|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 4 years after first dose of vaccine|Population consists of all participants who received at least one dose of vaccine.|||participants|||Number
1255751|NCT00464308|Secondary|The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods||4 weeks||||percent of participants||95% Confidence Interval|Mean
1255752|NCT00464308|Primary|The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4|Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds ‘mild’ (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.|4 weeks||||participants|||Number
1255753|NCT00464308|Primary|The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4|Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds ‘mild’ (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.|4 weeks|Symptom scores 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe|||participants|||Number
1255754|NCT00464308|Primary|The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4|Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.|4 weeks||||participants|||Number
1255755|NCT00464308|Secondary|The Median Time to Complete Relief of Regurgitation Symptoms||4 weeks|ITT population|||days||95% Confidence Interval|Median
1255756|NCT00464308|Secondary|The Median Time to Complete Resolution of Heartburn Symptoms.||week 4 of treatment|ITT population|||days||95% Confidence Interval|Median
1255757|NCT00464308|Primary|The Number of Patients With Complete Resolution of Heartburn by Week 4|Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.|week 4 of treatment|The intent-to-treat (ITT) population was used for all efficacy analyses. The data were reanalysed using the compliance population (defined as all subjects who consumed at least 80% of study medication and who completed at least 80% of data recording).|||participants|||Number
1255758|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255759|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255760|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255761|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255762|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255763|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255764|NCT00464269|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'|Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||percentage of participants|||Number
1255765|NCT00464269|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'|Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||percentage of participants|||Number
1255814|NCT00463801|Secondary|Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous||At day 14|||||||
1255864|NCT00463385|Secondary|Change From Baseline in Hemoglobin Concentration for Responders|Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment.|Baseline, Cycle 6 (168 days)|Intent-to-treat participants with a clinical response and available hemoglobin values at each time point.|||g/dL||Full Range|Median
1255766|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255767|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255768|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255769|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255770|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
1255771|NCT00464269|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|Baseline to 12-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.~Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."|||percentage of participants|||Number
1255772|NCT00464269|Secondary|Time to Tenth Type I Seizure During the 12-week Treatment Period|The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||days||95% Confidence Interval|Median
1255836|NCT00463580|Secondary|Plasma Concentrations of CRP|This study collected blood samples to assess inflammatory markers. CRP increases when inflammation is present and can be measured with a high sensitivity-CRP (hs-CRP) test. Hs-CRP values <1 milligram per liter (mg/L) indicate low inflammation while values >10mg/L indicate inflammation.|Baseline, Week 12||||mg/L||Standard Deviation|Mean
1255773|NCT00464269|Secondary|Time to Fifth Type I Seizure During the 12-week Treatment Period|The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||days||95% Confidence Interval|Median
1255774|NCT00464269|Secondary|Time to First Type I Seizure During the 12-week Treatment Period|The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||days||95% Confidence Interval|Median
1255775|NCT00464269|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period|"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:~(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||percentage of participants|||Number
1255776|NCT00464269|Secondary|Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period|"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.~Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||percentage of participants|||Number
1255777|NCT00464269|Secondary|Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|"Percent change from Baseline was calculated as percent reduction by:~(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).~The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||Percent change in POS frequency||Inter-Quartile Range|Median
1255778|NCT00464269|Secondary|All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period|"There are three different types of seizures:~Type I: Partial seizures~Type II: Generalized seizures~Type III: Unclassified epileptic seizures.~All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||seizures per week||Inter-Quartile Range|Median
1255779|NCT00464269|Secondary|Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||participants|||Number
1255780|NCT00464269|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|"Partial (Type I) seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to generalized tonic-clonic convulsions.~Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:~(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||seizures per week||Inter-Quartile Range|Median
1255837|NCT00463580|Secondary|Plasma Concentrations of Interleukin-6 (IL-6)|This study collected blood samples to assess inflammatory markers. IL-6 is a proinflammatory cytokine that is elevated during times of inflammation, infection, illness, and in patients with mood disorders. IL-6 is not present or is low in healthy individuals and exact reference ranges vary by lab, with an example normal reference range of 0.31 to 5.00 picograms per milliliter (pg/mL).|Baseline, Week 12||||pg/ml||Standard Deviation|Mean
1255781|NCT00464204|Other Pre-specified|Changes in Renal Function: 3. Risk, Injury, Failure, Loss, End-stage Kidney Disease (RIFLE) Classification|"Risk, Injury, Failure, Loss, End-stage kidney disease (RIFLE) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study.~RIFLE comprises five categories: Risk (R), Injury (I), Failure (F), Loss (L), End-stage kidney disease (E) (worst outcome). R, I and F are based on increase in serum creatinine. L and E are based on administration of renal replacement therapy."|From screening to end of follow-up|Treated population (TRT) = all randomized patients treated with study drug|||Participants|||Number
1255782|NCT00464204|Other Pre-specified|Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification|Acute Kidney Injury Network (AKIN) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study. AKIN ranges from stage 1 to stage 3 (worst outcome). Stages differ in serum creatinine increase. Stage 1: Increase ≥ 0.3mg/dL or ≥ 150%-200% from reference; Stage 2: Increase ≥ 200%-300% from reference; Stage 3: Increase >300% from reference with an acute increase of at least 0.5mg/dL or renal replacement therapy.|From screening to end of follow-up|Treated population (TRT) = all randomized patients treated with study drug|||Participants|||Number
1255783|NCT00464204|Other Pre-specified|Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening|Acute Renal Failure (ARF) was defined as a two fold increase in serum concentration over the value at screening at any time after screening.|From screening to end of follow-up (up to day 90)|Treated population (TRT) = all randomized patients treated with study drug. Patients without ARF were excluded from analysis if they had no creatinine value at Screening or no post-screening creatinine value.|||Participants|||Number
1255784|NCT00464204|Other Pre-specified|Mortality|Mortality was reported for the time period from Screening until the end of follow-up.|From Screening to end of Follow-up|Treated population (TRT) = all randomized patients treated with study drug. Two patients in the Voluven® arm died due to non-treatment emergent SAEs.|||Participants|||Number
1255785|NCT00464204|Secondary|Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4|"The Sepsis-related Organ Failure Assessment (SOFA) score in this study is reported for entire days, not for exact time points on a day. Potentially, more than one SOFA score may be available for the same day. In this case, the mean of the respective total scores was used for that day for calculation of Area Under the Curve (AUC).~The SOFA score includes sub-scores for Respiration, Coagulation, Liver, Cardiovascular, Central Nervous System and Renal function and may range from 0 (worst outcome) to 4 (best outcome)."|From Screening to Day 4|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Scores on a scale||Standard Deviation|Mean
1255786|NCT00464204|Secondary|Length of Stay in the Hospital|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from hospital (up to Day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Imputed with the longest possible duration for patients who died before end of the study of the individual patient."|||Days||Standard Deviation|Mean
1255787|NCT00464204|Secondary|Length of Stay in the Hospital|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from hospital (up to day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Calculated for patients who did not die before end of study of the individual patient."|||Days||Standard Deviation|Mean
1255788|NCT00464204|Secondary|Length of Stay in the ICU|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., worst possible value).|Until discharge from ICU (up to Day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Imputed with the longest possible duration for patients who died before end of the study of the individual patient."|||Days||Standard Deviation|Mean
1255789|NCT00464204|Secondary|Length of Stay in the Intensive Care Unit (ICU)|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from ICU (up to day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Calculated for patients who did not die before end of study of the individual patient"|||Days||Standard Deviation|Mean
1255790|NCT00464204|Secondary|Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition|This amount will be calculated from start of enteral nutrition until 7 am of day 8|7 days|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||kcal||Standard Deviation|Mean
1255791|NCT00464204|Secondary|Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization|Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.|up to 48 hours|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Hours||Standard Deviation|Mean
1255792|NCT00464204|Secondary|Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition|Time from start of fluid resuscitation with study drug to start of enteral nutrition.|Until start of enteral nutrition (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Hours||Standard Deviation|Mean
1255793|NCT00464204|Secondary|Quantity of Study Drug in 4 Days|Total quantity of study drug infused over four consecutive days in the ICU|4 days|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Milliliter||Standard Deviation|Mean
1255795|NCT00464204|Primary|Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization|Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.|until hemodynamic stabilization (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.|||Milliliter||Standard Deviation|Mean
1255796|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after PCI||||participants|||Number
1255797|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after randomization, during PCI||||participants|||Number
1255798|NCT00464087|Secondary|Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis|Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis|during index hospitalization||||participants|||Number
1255799|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after Fondaparinux administration, prior to randomization||||participants|||Number
1255800|NCT00463866|Secondary|Mean Cost Per Participant Per Country|Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.|6 months|||||||
1255801|NCT00463866|Secondary|The Mean Total Daily Dose of Steroids From Symbicort.|The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.|4 weeks|: Data for this measure recorded by 3874 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2*2 Reporting Group.|||μg budesonide per day||Standard Deviation|Mean
1255802|NCT00463866|Secondary|Mean Overall Asthma Control Questionnaire (ACQ) Score|The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.|6 months.|Data for this measure recorded by 3709 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2*2 Reporting Group.|||Scores in a scale||Full Range|Mean
1255803|NCT00463866|Secondary|Percent of Participants With a Well Controlled Asthma Week.|The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.|6 months.|Data for this measure recorded by 3714 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2*2 Reporting Group.|||Percentage of participants||Full Range|Mean
1255804|NCT00463866|Secondary|Mean Daily Number of Inhalations of As-needed Medication.|The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.|4 weeks|Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2*2 Reporting Group|||Inhalations per day per participant||Full Range|Mean
1255805|NCT00463866|Secondary|Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation|Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months.||||Days per participant||Standard Deviation|Mean
1255806|NCT00463866|Secondary|Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.|A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant|6 months.||||Number of events per participant||Full Range|Mean
1255807|NCT00463866|Secondary|Fraction of Participants With Severe Asthma Exacerbation|The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months.||||Fraction of participants with event||95% Confidence Interval|Mean
1255808|NCT00463866|Primary|Number of Severe Asthma Exacerbations Per Participant.|Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months||||Severe exacerbations per participant||Full Range|Mean
1255809|NCT00463840|Secondary|Median Overall Survival|This is the time at which 50% of patients are alive from the trial entry .|up to 10 years since the start of the study|Secondary Measure was not reported. Contacted PI. No new Data available.||||||
1255810|NCT00463840|Primary|Resectability After Chemoradiation|This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).|7.5 weeks|Based on intent-to-treat population.|||participants|||Number
1288236|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18||Month 18||||L||Standard Error|Mean
1255815|NCT00463801|Secondary|Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10|To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.|At day 4 and 10|||||||
1255816|NCT00463801|Secondary|Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria|To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.|At day 4, 7, 10 and 14|||||||
1255817|NCT00463801|Primary|Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start|Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.|at Day 7 and 14|Intention to treat (ITT) and safety population: all patients who received at least one dose of study medication.|||Participants|||Number
1255818|NCT00463788|Secondary|Safety- Number of Participants Experiencing Any Adverse Event (AE)|Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications.|Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010|Safety population included all the participants who received at least 1 dose of study medication (that is cisplatin or cetuximab).|||participants|||Number
1255819|NCT00463788|Secondary|Time to Response (TTR)|The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR.|Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.|||months||95% Confidence Interval|Median
1255820|NCT00463788|Secondary|Overall Survival (OS) Time|The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010|FAS population included all participants who were randomized as described in the pre-assignment details.|||months||95% Confidence Interval|Median
1255821|NCT00463788|Secondary|Progression-Free Survival (PFS) Time|The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.|||months||95% Confidence Interval|Median
1255822|NCT00463788|Primary|Best Overall Response (BOR)|Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.|||percentage of participants||95% Confidence Interval|Number
1255823|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)|The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for total cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1255824|NCT00463606|Secondary|Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)|The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for hsCRP. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Inter-Quartile Range|Median
1255825|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)|The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for ApoB. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1255826|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for VLDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1255827|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)|The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1255828|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)|The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1255829|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for low-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1255830|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)|The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1255831|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline and at least 1 post-baseline value for high-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1255832|NCT00463580|Secondary|Change in Hamilton Depression Rating Scale 17 (HDRS-17) Scores Subgrouped by Baseline Hs-CRP.|The effects of baseline high-sensitivity C-reactive protein (hs-CRP) on reduction in depressive symptoms were investigated by examining the least squares mean change in the HDRS score from baseline to week 12 (infliximab minus placebo) among participants with baseline CRP of >1 mg/L, >3 mg/L, and >5 mg/L. A negative change score favors infliximab. The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression.|Baseline, Week 12|This analysis includes all study participants in the first group then progressively limits participants in subsequent groups based on baseline hs-CRP concentrations.|||units on a scale||Standard Error|Least Squares Mean
1255833|NCT00463580|Secondary|Sleep Efficiency in High (CRP>5mg/L) Versus Low (CRP < or =5mg/L) Infliximab-treated Patients|Sleep efficiency is the percentage of time in bed spent sleeping (total sleep time/sleep period time x 100). A sleep efficiency of 80% or greater is considered normal. This outcome measure examines sleep efficiency between participants with high or low baseline CRP.|Baseline, Week 8|This analysis includes participants having complete polysomnography data at baseline and study week 8, who did not exhibit sleep apnea or {LMD, and who were treated with infliximab.|||percentage of time asleep||Standard Deviation|Mean
1255834|NCT00463580|Secondary|Sleep Efficiency|Sleep efficiency is the percentage of time in bed spent sleeping (total sleep time/sleep period time x 100). A sleep efficiency of 80% or greater is considered normal. This outcome measures examines sleep efficiency between study treatment groups.|Baseline, Week 8|This analysis includes participants having complete polysomnography data at baseline and study week 8, and who did not exhibit sleep apnea or periodic limb movement disorder (PLMD).|||percentage of time asleep||Standard Deviation|Mean
1255835|NCT00463580|Secondary|Plasma Concentrations of Tumor Necrosis Factor (TNF)-Alpha|This study collected blood samples to assess inflammatory markers. Tumor necrosis factor (TNF)-alpha values are invalid due to the administration of infliximab which interferes with the assay procedure.|Baseline, Week 12|TNF-alpha values were invalid due to the administration of infliximab interfering with processing TNF-alpha.||||||
1263810|NCT00407537|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Month 4||Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||mmHG||95% Confidence Interval|Least Squares Mean
1255838|NCT00463580|Secondary|Inventory of Depressive Symptomatology-Self-Report (IDS-SR) Scores|The Inventory of Depressive Symptomatology-Self-Report (IDS-SR) is a 30-item questionnaire asking respondents about symptoms of depression that they have experienced in the past 7 days. Each item is scored on a 4-point scale where 0 means that the symptom is absent and 3 means that the symptom is very strongly felt. Total scores can range between 0 and 84 and higher scores indicate more severe symptoms of depression.|Baseline, Weeks 1, 2, 4, 6, 8, 10 and 12||||units on a scale||Standard Deviation|Mean
1255839|NCT00463580|Secondary|Number of Remitted Patients During Treatment|The number of participants achieving depression remission are presented here. Depression remission is defined as an HDRS score of ≤7 or a Clinical Global Impression-Improvement (CGI-I) score of 1. The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression. The CGI-I scale includes a single item where a health care provider rates the participant's level of clinical improvement on a scale of 1 to 7 where 1 = very much improved since initiation of treatment and 7 = very much worse since initiation of treatment.|Week 12|All participants beginning the study are included in this analysis.|||participants|||Number
1255840|NCT00463580|Secondary|Number of Participants With a 50% Reduction in Hamilton Depression Rating Scale (HDRS) Scores|The number of participants with a 50% reduction in Hamilton Depression Rating Scale (HDRS) scores at any study point are presented here. The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression.|Week 12|All participants beginning the study are included in this analysis.|||participants|||Number
1255841|NCT00463580|Primary|Hamilton Depression Rating Scale 17 (HDRS-17) Scores|The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression.|Baseline, Weeks 1, 2, 4, 6, 8, 10 and 12|All participants beginning the study are included in this analysis.|||scores on a scale||Standard Deviation|Mean
1255842|NCT00463567|Other Pre-specified|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment|"Interim Analysis: Stage 1.~Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates."|Day 14, After 2 Weeks of treatment in Stage 1|Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for AUC 1h-4h FEV1 at Day 14. Missing data were imputed using last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1255843|NCT00463567|Other Pre-specified|Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment|"Interim Analysis: Stage 1.~Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates."|Day 15, After 2 Weeks of treatment in Stage 1|Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for Trough FEV1 at Day 15. Missing data were imputed using last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1255844|NCT00463567|Secondary|"The Percentage of Days of Poor Control Reported Over the 26 Week Treatment Period"|"A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of “days of poor control” as well as FEV1 reversibility components as covariates."|up to 26 weeks|Intent to Treat population consisting of all participants in Stage 2 of the study who received at least one dose of study drug. Eligible participants for the analysis were those with ≥7 evaluable diary days in the baseline period and ≥30% evaluable diary days (at least 20 days) in total.|||Percentage of days||Standard Error|Least Squares Mean
1255845|NCT00463567|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.|after 12 weeks of treatment|Participants from the Intent to Treat Population of Stage 2 of the study who received at least one dose of study drug and for whom data was available for FEV1 at 12 weeks. Imputed with last observation carried forward.|||Liters||Standard Error|Least Squares Mean
1255846|NCT00463437|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value|Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1255862|NCT00463385|Secondary|Change From Baseline in Likert Abdominal Pain Scale|Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable.|Baseline and Cycle 6 (168 days)|Intent-to-treat patients with available data.|||units on a scale||Standard Deviation|Mean
1255847|NCT00463437|Secondary|Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value|Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1255848|NCT00463437|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value|Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1255849|NCT00463437|Secondary|Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value|Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1255850|NCT00463437|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was ≥ 8.~The cross-reactive pneumococcal serotypes assessed include 6A and 19A."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1255851|NCT00463437|Secondary|Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).~The cross-reactive pneumococcal serotypes assessed include 6A and 19A."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1255852|NCT00463437|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value|"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8.~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1255853|NCT00463437|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
1255854|NCT00463437|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the beginning of the study up to the end of the extended 6-month safety follow-up period||||subjects|||Number
1255855|NCT00463437|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day (Day 0-30) period after the booster vaccination||||subjects|||Number
1255856|NCT00463437|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-30) period after the booster vaccination||||subjects|||Number
1255857|NCT00463437|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.|During the 4-day (Day 0-3) period after the booster vaccination|Subjects from the Total Vaccinated cohort for whom data were available.|||subjects|||Number
1255858|NCT00463437|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day (Day 0-3) period after the booster vaccination|Subjects from the Total Vaccinated cohort for whom data were available.|||subjects|||Number
1255859|NCT00463437|Primary|Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)|Fever was measured as rectal temperature.|During the 4-day (Day 0-3) period after the booster vaccination|Analysis was performed on the Total vaccinated cohort from Pn-HibC and Pr-HibC Groups on subjects for whom data were available.|||subjects|||Number
1255860|NCT00463385|Secondary|Number of Participants With Adverse Events (AEs)|"A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above).~The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale:~Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death.~The Investigator determined the relationship between study drug and the occurrence of an AE as “Not Related” or “Related” (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa)."|From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months).|Safety population (all treated patients).|||participants|||Number
1255861|NCT00463385|Secondary|Percentage of Participants With Clinical Response by Baseline JAK2 Assessment|Percentage of participants who achieved a clinical response, presented by participants with positive and negative janus kinase 2 (JAK2) V617F mutation results at Baseline.|Up to 336 days|Intent-to-treat population with non-missing JAK2 Baseline assessment results. The number of participants analyzed indicates the number of participants with a positive or negative JAK2 result for each treatment group respectively.|||percentage of participants|||Number
1255865|NCT00463385|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores|"The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life.~Physical Well-being consists of 7 questions, the subscale score ranges from 0-28;~Social/Family Well-being consists of 7 questions, the subscale score ranges from 0-28;~Emotion Well-being consists of 6 questions, the subscale score ranges from 0-24;~Functional Well-Being consists of 7 questions, the subscale score ranges from 0-28;~Anemia subscale consists of 20 questions, the subscale score ranges from 0-80;~Total FACT-An score ranges from 0-188."|Baseline and Cycle 6 (168 days).|Intent-to-treat patients with available data.|||units on a scale||Standard Deviation|Mean
1255866|NCT00463385|Secondary|Duration of First Clinical Response|"For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administrated at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment.~For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement.~Kaplan-Meier methodology was used."|Up to 40 months|Intent-to-treat population with a clinical response.|||months||95% Confidence Interval|Median
1255867|NCT00463385|Secondary|Time to the First Clinical Response|"The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as:~Start date of the first clinical response – the first study drug date +1.~A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable."|Up to 168 days|Intent-to-treat population with a clinical response|||weeks||Full Range|Median
1255868|NCT00463385|Secondary|Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment|"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders."|Up to 336 days|Intent-to-treat (ITT), defined as as all patients who were randomized, independent of whether they received study treatment or not.|||percentage of participants||95% Confidence Interval|Number
1255869|NCT00463385|Primary|Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment|"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders."|Up to 168 days|Modified intent-to-treat (MITT), defined as the patients who had a confirmed diagnosis of Myelofibrosis with myeloid metaplasia (MMM), received at least one dose of study drug, and participated in the study for at least 56 days.|||percentage of participants||95% Confidence Interval|Number
1255870|NCT00463346|Primary|Psychotic Symptoms - Measured Using the PANSS|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms.|12 weeks||||units on a scale||Standard Error|Mean
1255871|NCT00463346|Primary|Number of Drinking Days||12 weeks||||days||Standard Deviation|Mean
1255872|NCT00463229|Secondary|Kessler - 10|The Kessler-10 assesses level of anxiety and depressive symptoms a person may have experienced in the most recent four-week period. Its main strength is a superior ability to screen for anxiety and affective disorders. Each item is assigned a score ranging from 5 (all of the time) to 1 (none of the time). These 10 items are summed to give scores ranging from 10-50, where 50 indicates high risk of anxiety or depressive disorder. Previous studies have established a cut-off score of 16-29/50 for medium risk, and 30-50/50 as high risk for anxiety and depressive disorders.|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
1255873|NCT00463229|Secondary|Personal Resource Questionnaire (PRQ85-Part Two)|The PRQ85–Part Two is a 25-item scale that measures perceived social support along five dimensions: provision for attachment/intimacy; social integration; opportunity for nurturing behaviour; reassurance of worth as an individual and in role accomplishments; and the availability of informational, emotional, and material help. Scores range from a minimum of 25 to maximum score of 175; a higher score indicates a greater perception of social support.|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
1271037|NCT00352053|Secondary|Change From Baseline to Week 144 in CD4 Count||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method|||cells/mm^3||Inter-Quartile Range|Median
1255874|NCT00463229|Secondary|Centre for Epidemiological Studies in Depression Scale (CES-D)|The CES-D scale is a 20-item, self-reported questionnaire that assesses the current frequency of depressive symptoms. Total scores can range from 0 to 60; the higher the score, the more depressed. Values were determined by taking the value of the 12-month data (Timepoint 2) and subtracting them from the baseline data (Timepoint 1).|Baseline and 12 months|Timepoint 2 minus Timepoint 1|||units on a scale||Standard Deviation|Mean
1255875|NCT00463229|Secondary|Short Portable Mental Status Questionnaire.|The 10-item Short Portable Mental Status Questionnaire (SPMSQ) is used for the screening, diagnosis and assessment of cognition. The SPMSQ is short, easily administered and has been designed, tested, standardized and validated in a variety of populations, including stroke. The SPMSQ consists of 10 items. The individual items sum to provide a total score, ranging from 0-10; with greater than 4 errors indicating some degree of intellectual impairment. The higher the score, the less impairment.|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
1255876|NCT00463229|Secondary|Reintegration to Normal Living Index|"The RNLI assesses global functional status and measures both the stroke survivors’ perceptions of their own capabilities and objective indicators of physical, social, and psychological performance. The RNLI consists of 11 items which cover the domains of mobility, self-care abilities, daily activities, recreational and social activities, family roles, and personal relationships, presentation of self and general coping skills. Each item is scored as 0 to 2. Minimum score is 0 and maximum score is 22. The individual items sum to provide a total score, with 22 indicating the highest degree of reintegration."|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
1255877|NCT00463229|Secondary|Stroke Impact Scale - 16|The SIS-16 assesses several aspects of health-related quality of life that are important to stroke survivors, caregivers, and healthcare professionals. The SIS-16 consists of 16 items which cover the physical aspects of stroke including: strength, hand function, mobility, and activities of daily living/instrumental activities of daily living. Each item is assigned a score ranging from 1 (could not do at all) to 5 (not difficult at all). The individual items sum to provide a total score (range from 16 to 80), with higher scores indicating higher levels of health-related quality of life and function.|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
1255878|NCT00463229|Primary|Change Between the Value of the SF-36 Physical Function Score at 12 Months Minus Value at Baseline to Measure the Change in Health-related Quality of Life and Function|The primary measure of effect was the change in health-related quality of life and functioning from baseline to 12-months as measured by the SF-36 physical functioning score. The range of possible scores for this subscale is 0-100, with a higher score indicating a more favourable health status.|Baseline (pre-randomization) and 12 months||||Units on a scale||Standard Deviation|Mean
1255879|NCT00463060|Secondary|Number of Participants According Failure and Survival||4 years||||Participants|||Count of Participants
1255880|NCT00463060|Secondary|Quality of Life||4-6 weeks after radiation therapy|data not collected||||||
1255881|NCT00463060|Secondary|Percentage of Patients With Distant Control|Distant control defined as distant metastasis contained outside of the radiation field within months of treatment.|4 weeks||||percentage of participants||95% Confidence Interval|Number
1255882|NCT00463060|Secondary|Percentage of Patients With Local Control|Local control was defined as a tumor volume equal to or less than the tumor volume at start of radiotherapy.|4 years|the 4-year estimates for local control|||percentage of participants||95% Confidence Interval|Number
1255883|NCT00463060|Secondary|Percentage of Patients With Toxicity Grade 3 or Higher|% of patients experienced one or more grade ≥ 3 toxicities. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4),and death (Grade 5).|5 years||||Participants|||Count of Participants
1255884|NCT00463060|Primary|Number of Participants With Particular Disease Status|Number of participants who have no evidence of disease and number of participants with distant metastases.|5 years|Phase 2 only|||participants|||Number
1255885|NCT00463060|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|Sunitinib (SU) and radiation (IGRT) doses were sequentially escalated using a ping-pong strategy according to a 3 + 3 design phase 1 study. The starting dose was sunitinib 25 mg and IGRT 40 Gy. MTD reflects the highest dose that did not cause a dose limiting toxicity. Toxicity was in assessed in patients at regular intervals by using the Common Terminology Criteria for Adverse Events criteria (version 3.0). Dose limiting events were defined as any grade 4 or 5 toxicity and unexpected grade 3 toxicity. Expected grade 3 toxicities from radiation include mucositis or esophagitis lasting ≤7 days. Grade 3 metabolic and hematologic toxicities are considered expected events with sunitinib and therefore were not considered DLTs|2 years||||Participants|||Count of Participants
1255886|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the Endpoint (time of the last observation during the treatment period)who responded to each option is presented.|Endpoint (End of second double-blind treatment period or last observation after start of treatment period)|Double-blind safety analysis set: 88 subjects who received FBT and 94 subjects who received Oxycodone at any time during the double-blind treatment period who completed the PFTS questionnaire|||Participants|||Number
1255887|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the second double-blind treatment period (Visit 6) who responded to each option is presented.|At the end of the second double-blind treatment period (Visit 6)|Double-blind safety analysis set: 83 subjects who received FBT and 87 subjects who received Oxycodone in the second double-blind period|||Participants|||Number
1255888|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the first double-blind treatment period (Visit 5) who responded to each option is presented.|The end of the first double-blind treatment period.|Double-blind safety analysis set: 88 subjects who received FBT and 90 subjects who received Oxycodone in the first double-blind period|||Participants|||Number
1255889|NCT00463047|Secondary|Breakthrough Pain Preference Questionnaire|The BTP preference questionnaire is a questionnaire used to measure patients’ preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient’s preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.|After completion of both double-blind treatment periods or early termination|Double-blind safety analysis set: 190 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment|||Participants|||Number
1255890|NCT00463047|Secondary|Medication Performance Assessment 60 Minutes After-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|60 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Number of episodes treated|Participants||Number
1255891|NCT00463047|Secondary|Medication Performance Assessment 30 Minutes After-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|30 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Number of episodes treated|Participants||Number
1255892|NCT00463047|Secondary|Standard Rescue Medication Usage|Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient’s diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.|During the administration of study drug during the double blind treatment periods.|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Number of episodes treated|Participants||Number
1255893|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 60 minutes was compared.|Time of study drug administration until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255894|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 45 minutes was compared.|From study drug administration until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255910|NCT00463047|Secondary|Pain Relief Score (PR) at 15 Minutes|The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|15 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1255895|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 30 minutes was compared.|Time of study drug administration until 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255896|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 15 minutes was compared.|Time of study drug administration until 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255897|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 10 minutes was compared.|Time of study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255898|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes|Time to MPR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment period. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to meaningful pain relief fell into that category was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255899|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=60 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 60 minutes was compared.|Time of study drug treatment until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255900|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=45 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 45 minutes was compared.|Time of study drug treatment until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255901|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=30 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 30 minutes was compared.|Time of study drug administration till 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1263811|NCT00407537|Secondary|Mean Systolic and Diastolic Blood Pressure at Month 12||Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||mmHg||Standard Deviation|Mean
1255902|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=15 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 15 minutes was compared.|From study drug administration to 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255903|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=10 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 10 minutes was compared.|From study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255904|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes|Time to APR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment period. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 5 minutes was compared.|From time was administered to 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
1255905|NCT00463047|Secondary|Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)|The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) times 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.|From 5 minutes through 60 minutes after study drug treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Percent change in units on a scale||Standard Deviation|Mean
1255906|NCT00463047|Secondary|Total Pain Relief (TOTPAR60) at 60 Minutes|"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes to 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255907|NCT00463047|Secondary|Pain Relief Score (PR) at 60 Minutes|The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|60 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1255908|NCT00463047|Secondary|Pain Relief Score (PR) at 45 Minutes|The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|45 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1255909|NCT00463047|Secondary|Pain Relief Score (PR) at 30 Minutes|The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|30 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1288237|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18||Month 18||||L||Standard Error|Mean
1255911|NCT00463047|Secondary|Pain Relief Score (PR) at 10 Minutes|The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|10 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1255912|NCT00463047|Secondary|Pain Relief (PR) Score at 5 Minutes|The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient’s diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|Five minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1255913|NCT00463047|Secondary|Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)|"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes after dosing through 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255914|NCT00463047|Secondary|Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)|PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|From 5 minutes after dosing through 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255915|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 60 minutes divided by the baseline PI score times 100.|Immediately before and 60 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on a scale||Standard Error|Mean
1255916|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 45 minutes divided by the baseline PI score times 100.|Immediately before and 45 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on scale||Standard Error|Mean
1255917|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 30 minutes divided by the baseline PI score times 100.|Immediately before and 30 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on a scale||Standard Error|Mean
1255942|NCT00462943|Secondary|Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)|"Cytogenetic response categories:~Complete: 0% Ph+ cells~Partial: >0%-35% Ph+ cells~Minor: >35%-65% Ph+ cells~Minimal: >65%-95% Ph+ cells~No Response: >95% Ph+ cells~Unevaluable: <20 metaphases were examined and/or response could not be assigned"|Day 1 up to Month 9|Intent to treat|||percentage of participants|||Number
1255918|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 15 minutes divided by the baseline PI score times 100.|Immediately before and 15 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on a scale||Standard Error|Mean
1255919|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 10 minutes divided by the baseline PI score times 100.|Immediately before and 10 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change in units on a scale||Standard Error|Mean
1255920|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 5 minutes divided by the baseline PI score times 100.|Immediately before and 5 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on a scale||Standard Error|Mean
1255921|NCT00463047|Secondary|Pain Intensity Difference (PID 60) at 60 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 60 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255922|NCT00463047|Secondary|Pain Intensity Difference (PID 45) at 45 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 45 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255923|NCT00463047|Secondary|Pain Intensity Difference (PID 30) at 30 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 10 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255977|NCT00462709|Primary|Frequency of All HAE Attacks|A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.|Duration of the study|Intent-to-treat Efficacy (ITT-E) Population (N=146; the number of subjects who received at least one prophylactic dose of C1INH-nf for the prevention of HAE attacks). HAE attack frequency was reported by 137 subjects at screening (i.e., data were missing for 9 subjects).|||attacks per month||Full Range|Median
1255978|NCT00462670|Secondary|Body Weight (Percent Change)|Percent change in body weight from baseline at the time of final trial drug administration|baseline, Day 7 or at the time of final trial drug administration||||percentage of body weight (Kg)||Standard Deviation|Mean
1255924|NCT00463047|Secondary|Pain Intensity Difference (PID 10) at 10 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 10 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255925|NCT00463047|Secondary|Pain Intensity Difference (PID 5) at 5 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 5 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255926|NCT00463047|Primary|Pain Intensity Difference (PID15) At 15 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and fifteen minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1255927|NCT00462982|Primary|Central Nervous System (CNS) Response Rate by RECIST Criteria|Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.|up to a year||||participants|||Number
1255928|NCT00462943|Secondary|Kaplan-Meier Estimates for Overall Survival|Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.|up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
1255929|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Disease Progression|Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.|up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
1255930|NCT00462943|Secondary|Kaplan-Meier Estimates for Duration of Best Cytogenetic Response|Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to four years|Intent to treat population of participants who had a response|||months||Full Range|Median
1255931|NCT00462943|Secondary|Kaplan-Meier Estimates for Duration of Best Hematologic Response|Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to four years|Intent to treat population of participants who had a response|||months||Full Range|Median
1255979|NCT00462670|Primary|Body Weight (Amount of Change)|Change in body weight from baseline at the time of final trial drug administration|baseline, Day 7 or at the time of final trial drug administration||||Kg||Standard Deviation|Mean
1255980|NCT00462644|Secondary|Number of Deaths|deaths|death in hospital||||participants|||Number
1255981|NCT00462644|Primary|Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)||60 minutes after administration of cotrosyn||||micrograms/dL||Standard Deviation|Mean
1255982|NCT00462644|Primary|Change in Baseline Cortisol|change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)|4-6hr after RSI||||micrograms/dL||Standard Deviation|Mean
1255932|NCT00462943|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total|"TEAE are any untoward events that were newly occurring or worsening from Baseline.~Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~A participant is only counted once in each category (at worst severity or strongest relationship)."|up to 4 years|Intent to treat|||participants|||Number
1255933|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells."|Day 1 up to Month 9|Intent to treat population.|||months||95% Confidence Interval|Median
1255934|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful."|Day 1 up to Month 6|Intent to treat population.|||months||95% Confidence Interval|Median
1255935|NCT00462943|Secondary|Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response||Day 1 up to Month 9|Intent to treat population of participants who had a cytogenetic response|||treatment cycles||Full Range|Median
1255936|NCT00462943|Secondary|Number of Treatment Cycles Needed to Achieve Best Hematologic Response|Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m^2 twice a day (BID) for the 14 consecutive days.|Day 1 up to Month 6|Intent to treat population of participants who had a response to treatment|||treatment cycles||Full Range|Median
1255937|NCT00462943|Secondary|Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL|Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).|Day 1 up to Month 9|Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL|||percentage of participants||95% Confidence Interval|Number
1255938|NCT00462943|Secondary|Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response|"Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).~Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed)."|Day 1 up to Month 9|Intent to treat population of study participants who had extramedullary disease at baseline|||percentage of participants|||Number
1255939|NCT00462943|Secondary|Percentage of Participants in Each Hematologic Response Category|"Complete Response (CHR)~Chronic phase must last at least 8 weeks: WBC <10*10^9/liter, platelets <450*10^9/liter, myelocytes + metamyelocytes <5% in blood, no blasts or promyelocytes in blood, <20% basophils in peripheral blood, no extramedullary involvement.~Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5*10^9/liter, platelets 100*10^9/liter, no blood blasts, bone marrow blasts <5%, no extramedullary disease.~Partial Response - CHR plus one or more of the following:~Persistence of splenomegaly with a reduction of ≥50% from pre-treatment~Platelets > 450*10^9/L~Presence of immature cells in the peripheral blood~5% to 25% blasts in the bone marrow~If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (<100*10^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as <5% bone marrow blasts."|Day 1 up to Month 6|Intent to treat|||percentage of participants|||Number
1255940|NCT00462943|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.|||percentage of participants||95% Confidence Interval|Number
1255941|NCT00462943|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.|||percentage of participants||95% Confidence Interval|Number
1271038|NCT00352053|Secondary|Change From Baseline to Week 96 in CD4 Count||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method|||cells/mm3||Inter-Quartile Range|Median
1255943|NCT00462943|Primary|Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 9 months|Intent to treat population|||percentage of participants||95% Confidence Interval|Number
1255944|NCT00462943|Primary|Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat population|||percentage of participants||95% Confidence Interval|Number
1255945|NCT00462917|Secondary|Impact of Events Scale (IES)|A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.|6 weeks, 6 months, 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."|||score on a scale||Standard Deviation|Mean
1255946|NCT00462917|Primary|Beck Anxiety Inventory (BAI)|A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.|6 weeks, 6 months, 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."|||score on a scale||Standard Deviation|Mean
1255947|NCT00462917|Primary|Center for Epidemiological Studies-Depression Scale (CES-D)|A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.|6 weeks, 6 months, and 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."|||score on a scale||Standard Deviation|Mean
1255948|NCT00462865|Secondary|To Monitor the Rate of Recurrent Disease, Either Local This Population.||6 months and again at the end of the study (1 year)|||||||
1255949|NCT00462865|Primary|Toxicity Issues of Administering 6 Cycles of Gemcitabine, Capecitabine, and Avastin and One Year of Consolidation of Avastin in Women With Breast Cancer Previously Treated With Neoadjuvant Chemotherapy That Lead to Patients Being Taken Off Study.|6 out of 17 patients came off study for toxicity prior to receiving all treatment.|1 year||||participants|||Number
1255950|NCT00462839|Secondary|Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.||1 hour||||participants|||Number
1255951|NCT00462839|Secondary|Level of Training||1 hour||||participants|||Number
1255952|NCT00462839|Secondary|Number and Type of Care Providers Assigned to Study Arms.||1 hour|per protocol|||participants|||Number
1255953|NCT00462839|Primary|Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.|Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.|1 hour|per protocal|||milliliters||95% Confidence Interval|Mean
1255954|NCT00462826|Secondary|Duration of Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and evaluable patients|||months||90% Confidence Interval|Median
1255955|NCT00462826|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.|Eligible and evaluable patients|||months||90% Confidence Interval|Median
1255956|NCT00462826|Primary|Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Adverse events at least possibly related to the study agent.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and evaluable patients.|||Participants|||Count of Participants
1255983|NCT00462644|Primary|Postintubation Cortisol (Baseline Cortisol Level)|cortisol level after randomization and rapid sequence induction|postintubation (baseline cortisol level)||||micrograms/dL||Standard Deviation|Mean
1255984|NCT00462644|Secondary|Ventilator Days||time from intubation to extubation||||days||Standard Deviation|Mean
1255957|NCT00462826|Primary|Objective Tumor Response (RECIST 1.0)|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.|Eligible and evaluable patients|||participants|||Number
1255958|NCT00462826|Primary|6 Month Progression-free Survival|Number of participants who survived progression-free for more than 6 months.|At 6 monthsEvery other cycle during treatment for the first 6 months.||||participants|||Number
1255959|NCT00462748|Primary|Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End|Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end.|6 Weeks|"The Full Analysis Set (FAS) all patients who were:~Randomised~Took at least one dose of double-blind medication~Had a baseline measurement of efficacy~Had a post-baseline measurement of efficacy~Patients were analysed according to the treatment group they were randomised, regardless of the treatment they received"|||Percent|||Number
1255960|NCT00462735|Secondary|Distant Metastases|Percentage of participants who did not have distant control|2 years||||percentage of participants|||Number
1255961|NCT00462735|Secondary|UW-QOLR: Quality of Life Score|University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).|2 years|Twenty patients completed the UW-QOLR questionnaire before and after therapy.|||units on a scale||Full Range|Mean
1255962|NCT00462735|Secondary|Long- Term Toxicity|Grade 3 toxicities events|2 years||||events|||Number
1255963|NCT00462735|Primary|Survival|Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology|2 years||||percentage of participants|||Number
1255964|NCT00462735|Primary|Llocoregional Recurrence|Percentage of Participants with Loco-regional recurrence.|2 years||||Participants|||Count of Participants
1255965|NCT00462722|Secondary|Expression of Selected Proteins and Genes Associated With Muscle Build-up and Breakdown||Baseline and after 9 months of training|Because of the costs associated with gene and protein expression techniques and data reduction, we did not pursue this secondary outcome after learning the results of the primary outcome (change in fat-free mass).||||||
1255966|NCT00462722|Secondary|Bone Turnover Markers||Baseline, and after 4.5 & 9 months of training|Because of the costs associated with the assays and data analysis of bone turnover markers, we did not pursue data collection after learning of the primary outcomes (changes in BMD).||||||
1255967|NCT00462722|Secondary|Change in Thigh Cross-sectional Muscle Area||Baseline and after 9 months of training|Because of the costs associated with data analysis for this secondary outcome, we did not pursue the analysis after learning the results of the primary outcome (fat-free mass).||||||
1255968|NCT00462722|Secondary|Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise groups had uninterpretable hip scans."|||percentage change in BMD||Standard Deviation|Mean
1255969|NCT00462722|Secondary|Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training||||percentage change in BMD||Standard Deviation|Mean
1255970|NCT00462722|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise group had uninterpretable spine scans."|||percentage change in BMD||Standard Deviation|Mean
1255971|NCT00462722|Primary|Change From Baseline in Fat-free Mass at 9 Months||Baseline and after 9 months of training||||change in kg||Standard Deviation|Mean
1255972|NCT00462722|Primary|Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise group had uninterpretable hip scans."|||percentage change in total hip BMD||Standard Deviation|Mean
1255973|NCT00462722|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Ibuprofen pre and placebo post exercise group had an uninterpretable spine scan."|||Percentage change in lumbar spine BMD||Standard Deviation|Mean
1255974|NCT00462709|Other Pre-specified|Complement C4 Serum Levels|Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=134).|||mg/dL||Standard Deviation|Mean
1255975|NCT00462709|Other Pre-specified|Functional C1INH Serum Levels|"Change from pre-infusion to 1 hour post-infusion in functional C1INH serum levels.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=132).|||percent||Standard Deviation|Mean
1255976|NCT00462709|Other Pre-specified|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=137).|||mg/dL||Standard Deviation|Mean
1255997|NCT00462462|Primary|Systemic Exposure to Ethanol With the Two Test Products: Determination of the Maximum Plasma Concentration (Cmax)|Blood samples were performed, just before infusion, then 5 min, 10 min, 20 min, 40 min, 60 min, 90 min, and 120 min after infusion at the first site, then every 60 min onwards until ethanol levels are found under the detection limit. Cmax was estimated directly from experimental data. If all the ethanol concentrations of a patient was below the limit of quantification of the laboratory (LOQ), Cmax was reported as LOQ/2 for this patient.|Baseline visit (just before and during test product infusion procedure)||||g/L||Full Range|Mean
1255998|NCT00462449|Secondary|Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)|upper extremity function during activities of daily living as reported by the patient. Scale runs 0 (not used) to 5 (normal function). No subscales used.|12 weeks|Per protocol|||units on a scale||95% Confidence Interval|Mean
1255999|NCT00462449|Secondary|Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)|Dextrous hand function measurement. Scale ranges from 0 (no dextrous arm function) to 57 (normal function)|12 weeks|Per protocol.|||units on a scale||95% Confidence Interval|Mean
1256000|NCT00462449|Primary|Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)|upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.|12 weeks|Per protocol. Number was determined based on the number of participants enrolled and eligible.|||units on a scale||95% Confidence Interval|Mean
1256001|NCT00462423|Secondary|Safety and Tolerability of This Combination|See adverse events Table|April 2007 through December 2010|||||||
1256002|NCT00462423|Secondary|Objective Response Rate (RR) in Patients With Measurable Lesions Time to Objective Response|The objective response rate is defined as the percentage of patients showing complete or partial response.|The median duration of follow-up for surviving patients was 41.6 months.||||Percentage of participants||95% Confidence Interval|Number
1256003|NCT00462423|Secondary|Overall Survival (OS)|The duration of overall survival was defined as the number of months between the start date of protocol treatment and the date of death (irrespective of cause), and was right-censored at the date of last contact for patients who were alive as of the data cutoff.|April 2007 through December 2010||||months||95% Confidence Interval|Median
1256004|NCT00462423|Secondary|Progression-free Survival|Median time of progression-free survival from first treatment according to RECIST 1.0|From start of treatment to disease progressin; median duration of follow-up for surviving patients was 41.6 months.||||Months||95% Confidence Interval|Median
1256005|NCT00462423|Primary|Progression-free Survival (PFS) at 4 Months|Progression-free survival at 4 months from first treatment as determined by RECIST 1.0|4 months.||||percentage of patients||95% Confidence Interval|Number
1256006|NCT00462384|Secondary|Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.|EEP (Weeks 29 to 36)|ITT population|||days||Standard Deviation|Mean
1256007|NCT00462384|Secondary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.|EEP (Weeks 29 to 36)|ITT population|||percentage of participants|||Number
1256008|NCT00462384|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.|EEP (Weeks 29 to 36)|ITT population|||percentage of participants|||Number
1256009|NCT00462384|Secondary|Time to Achievement of Response|Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.|Baseline to Week 40|ITT population|||days||Standard Deviation|Mean
1256010|NCT00462384|Primary|Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)|The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.|Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)|Intent to treat (ITT) population: included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom data for at least one study variable was available.|||grams per deciliter (g/dL)||Standard Deviation|Mean
1256011|NCT00462345|Secondary|Modified Sharp Radiographic Joint Space Narrowing Score (JSN)|JSN Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total scores for JSN in the hands was 100 and in the feet was 48, for a maximum overall score of 148. Total JSN was for both hands and feet.|Screening, Weeks 24 and 48|ITT population. 39 participants were analyzed for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1256012|NCT00462345|Secondary|Modified Sharp Radiographic Erosion Score (ES)|Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Maximum total erosion score in the hands was 100 and in the feet was 42, for a maximum overall score of 142. Total erosion score was for both hands and feet.|Screening, Weeks 24 and 48|ITT population|||scores on a scale||Standard Deviation|Mean
1256026|NCT00462345|Secondary|Disease Activity Score Based on 28-Joint Count (DAS-28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hr]) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT population|||scores on a scale||Standard Deviation|Mean
1256469|NCT00459810|Secondary|Measurable Disease Response Rate (Soft Tissue)|Measurable disease response rate by RECIST criteria. Response is defined as at least a 30% decrease in the sum of the longest diameter in measurable lesions (larger than 10mm at baseline).|While receiving study agents (on average, 3 months)||||Participants|||Number
1256013|NCT00462345|Secondary|Modified Total Sharp-Genant Score (mTSS)|Posterior-anterior (PA) radiograph of each hand and anterior-posterior (AP) radiograph of each foot were taken separately and assessed according to Genant’s method as modified from Sharp’s method. The Sharp-Genant score=total of the erosion score and the joint space narrowing (JSN) score of all the hands and feet. Erosion Score: 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. JSN Score:13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total erosion score in hands=100 and in feet=42; maximum scores for JSN in the hands=100 and in feet=48. Maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. Change in scores was calculated as change=final score minus initial score.|Screening and Weeks 24 and 48|ITT population|||scores on a scale||Standard Deviation|Mean
1256014|NCT00462345|Secondary|SF-36 Mental Component Scores|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Screening, Weeks 24 and 48|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1256015|NCT00462345|Secondary|Physical Function as Assessed by Short Form 36 (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Screening, Weeks 24 and 48|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1256016|NCT00462345|Secondary|HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Weeks 24 and 48|ITT population|||scores on a scale||Standard Deviation|Mean
1256017|NCT00462345|Secondary|Erythrocyte Sedimentation Rate (ESR)|The mean level of ESR (in mm/hr), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT population|||mm/hr||Standard Deviation|Mean
1256018|NCT00462345|Secondary|C-reactive Protein (CRP) Level|The mean level of CRP in milligrams per liter (mg/L), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT population|||mg/L||Standard Deviation|Mean
1256019|NCT00462345|Secondary|Patient Assessment of Pain (VAS)|The mean score of pain at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100-mm horizontal VAS, where the left endpoint indicated “No pain,” and the right endpoint indicated “Unbearable pain.” A negative change indicated improvement.|Baseline, Weeks 24 and 48|ITT population|||mm||Standard Deviation|Mean
1256020|NCT00462345|Secondary|Physician Global Assessment of Disease Activity (VAS)|"The mean score of the symptoms of RA at Week 0 and the change from Week 0 (baseline) to Weeks 24 and 48 as assessed by investigators using a 100-mm horizontal VAS, where the left endpoint indicated No disease activity” (no symptom, or no symptom of RA), and the right endpoint indicated “Maximum disease activity” (maximum RA activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24 and 48|ITT population|||mm||Standard Deviation|Mean
1256021|NCT00462345|Secondary|Patient Global Assessment of Disease Activity (VAS)|"The mean score of the symptoms of rheumatoid arthritis (RA) at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100 mm horizontal VAS, where the left endpoint indicated No disease activity” (no symptom, or no symptom of RA), and the right endpoint indicated “Maximum disease activity” (maximum RA activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24 and 48|ITT population|||mm||Standard Deviation|Mean
1256022|NCT00462345|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examination of 68 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of tender joints was recorded on the joint assessment form at each visit as either tender or not tender.|Baseline, Weeks 24 and 48|ITT population|||tender joints||Standard Deviation|Mean
1256023|NCT00462345|Secondary|Swollen Join Count (SJC)|Number of swollen joints was determined by examination of 66 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit as swollen or not swollen.|Baseline, Weeks 24 and 48|ITT population|||swollen joints||Standard Deviation|Mean
1256024|NCT00462345|Secondary|Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24|The percentage of participants categorized as good, moderate, or nonresponders according to the EULAR response criteria at Week 24. Participants were categorized as good responders if the intensity of their symptoms was in the “low disease activity (DAS28 less than [<]3.2)” category after treatment, and their symptoms significantly decreased to >1.2. Participants were categorized as moderate responders if the intensity of their symptoms was in the “moderate or high disease activity (DAS28 >3.2)” category after treatment, and the symptoms significantly decreased to >1.2; or if the intensity of their symptoms was in the “low or moderate disease activity (DAS28 <5.1)” category, and the DAS28 score changed more than 0.6 or 1.2 or less. Participants were categorized as non-responders if they did not fall into the good or moderate categories.|Week 24|ITT population|||percentage of participants|||Number
1256025|NCT00462345|Secondary|Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity.|Baseline, Week 24|ITT population|||percentage of participants|||Number
1256079|NCT00462020|Primary|Abscess After Appendectomy||1 month||||number of patients|||Number
1256027|NCT00462345|Secondary|Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24|ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1256028|NCT00462345|Secondary|Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24|ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1256029|NCT00462345|Primary|Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24|ACR20 response: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1256030|NCT00462332|Secondary|Disease-free Survival||At 2 years from study entry|||||||
1256031|NCT00462332|Secondary|Event-free Survival||At 2 years from study entry|||||||
1256032|NCT00462332|Secondary|Length of Survival||At 2 years and a half from study entry||||years||Standard Deviation|Mean
1256033|NCT00462332|Secondary|Toxicity|Number of AEs and SAEs|At 2 years from study entry|||||||
1256034|NCT00462332|Primary|Number of Patients With Complete Response|"Normal clinical or X-ray examination (lymph nodes, liver, spleen)~No symptoms~Lymphocytes higher or equal to 4.0 per 10^9/L~Neutrophils lower or equal to 1.5 per 10^9/L~Platelets >100 per 10^9/L~Hb >11.0 g/dL~Bone marrow lymphs according to age, lymphocytes <30%, no nodules."|At 2 years from study entry||||participants|||Number
1256035|NCT00462306|Secondary|Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires|Number of subjects with obstetrician diagnosis of pregnancy induced hypertension (pre-eclampsia) among subjects with a positive compared to a negative Berlin questionnaire. The Berlin Questionnaire consists of three categories. Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a Positive Berlin Questionnaire if 2 or more categories are positive.|1-2minutes|Analysis per protocol|||participants|||Number
1256036|NCT00462306|Primary|Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing|The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.|1-2 minutes|Pregnant Women presenting to Prentice Women's Hospital or non-pregnant women or childbearing age presenting for ambulatory surgery from 10/2005 to 9/2007 were selected randomly and asked to complete the survey.|||participants|||Number
1256037|NCT00462280|Secondary|At Least 1 Study-related Adverse Event Reported During the Study|All participants will be evaluable for toxicity from the time of their informed consent. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0.|Baseline up to 26 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm."|||participants|||Number
1256038|NCT00462280|Secondary|Change in C-reactive Protein (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
1256039|NCT00462280|Secondary|Change in CPK (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||U/L||95% Confidence Interval|Mean
1256040|NCT00462280|Secondary|Change in SGOT/ALT (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||U/L||95% Confidence Interval|Mean
1256041|NCT00462280|Secondary|Change in SGOT/AST (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||U/L||95% Confidence Interval|Mean
1256042|NCT00462280|Secondary|Change in Triglycerides (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
1256470|NCT00459810|Primary|Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%|PSA response rate is defined at the number of patients who experienced a PSA decline of equal to or greater than 50%, confirmed by a second measurement at least 4 weeks later.|While receiving study agents (on average, 3 months)||||Participants|||Number
1256043|NCT00462280|Secondary|Change in HDL (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
1256044|NCT00462280|Secondary|Change in LDL (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
1256045|NCT00462280|Secondary|Change in Cholesterol (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
1256046|NCT00462280|Secondary|Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation|Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256047|NCT00462280|Secondary|Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation|p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256048|NCT00462280|Secondary|Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation|RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256049|NCT00462280|Secondary|Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation|VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256050|NCT00462280|Secondary|Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation|(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256051|NCT00462280|Secondary|Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation|(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256052|NCT00462280|Secondary|Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation|HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256053|NCT00462280|Secondary|Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation|Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256054|NCT00462280|Secondary|Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation|p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1271039|NCT00352053|Secondary|Change From Baseline to Week 48 in CD4 Count||Baseline to 48 weeks|ITT Analysis Set, missing = excluded method|||cells/mm3||Inter-Quartile Range|Median
1256055|NCT00462280|Secondary|Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation|RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256056|NCT00462280|Secondary|Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation|VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256057|NCT00462280|Secondary|Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation|(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256058|NCT00462280|Primary|Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation|The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|From baseline up to 24 weeks|Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|||score||Standard Deviation|Mean
1256059|NCT00462280|Secondary|Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation|(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256060|NCT00462280|Secondary|Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation|HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
1256061|NCT00462280|Secondary|Total Nevus Number on Patient’s Back - Combined Three Reviewers' Evaluations|Assessed by photos of subjects’ back pre and post treatment. These photos will be used to count, by blinded evaluators, the number of nevi on the back pre and post therapy.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||pairs of photos|||Number
1256062|NCT00462280|Secondary|Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations|From close-up photos of target atypical nevi, lesions will be graded clinically. After unblinding of pre- or post-treatment status for photos, the grading score was as follows: 1= Post-treatment (Post-TX) photo shows a complete resolution of atypia relative to pre-treatment (Pre-TX) photo, 2 = Post-TX photo shows a strong lessening of atypia relative to Pre-TX photo, 3 = Post-TX photo shows a mild lessening of atypia relative to Pre-TX photo, 4 = Post-TX and Pre-TX photos show same degree of atypia, 5 = Pre-TX photo shows a mild lessening of atypia relative to Post-TX photo, 6 = Pre-TX photo shows a strong lessening of atypia relative to Post-TX photo, 7 = Pre-TX photo shows a complete resolution of atypia relative to Post-TX photo. The Wilcoxon rank sum test will be applied to compare the scores for patients treated with placebo vs. those treated with lovastatin.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||score||Standard Deviation|Mean
1256063|NCT00462280|Primary|Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation|The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|From baseline up to 24 weeks|Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|||score||Standard Deviation|Mean
1256471|NCT00459732|Secondary|Osteocalcin, a Marker of Bone Formation|Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups|Baseline to 18 months|Intention to treat analysis|||ng/mL||Standard Deviation|Mean
1256064|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT) Oral Score.|SDMT Oral Score: SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT oral scores.|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
1256065|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT)Written Score.|SDMT Written Scores. SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT written scores.|baseline, 6 weeks, 12 weeks|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
1256066|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Delayed Recall Score.|"BVMT-R Delayed recall. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations.~After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page.~These scores are for the delayed recall raw score which ranges from 0 to 12 with 12 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
1256067|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Total Recall Score.|"BVMT-R total recall score. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations. The total recall score is the sum of the three learning trials.~After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page.~These scores are for the total recall raw score which ranges from 0-36 with 36 being the highest and best possible score."|Baseline, 6 weeks, 12 weeks after beginning Namenda or placebo|All subjects who completed the study.|||units on a scale||Standard Deviation|Mean
1256068|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part B.|Trail Making Test Part B consists of 24 circles on a piece of paper, but rather than all of the circles containing numbers, half of the circles have the numbers 1-12 in them and the other half (12) contain the letters A-L. The person taking the test has the more difficult task of drawing a line from one circle to the next in ascending order; however, he must alternate the circles with numbers in them (1-13) with circles with letters in them (A-L). In other words, he is to connect the circles in order like this: 1-A-2-B-3-C-4-D-5-E and so on. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded.|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||seconds||Standard Deviation|Mean
1256069|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part A.|Trail Making Test Part A consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in the circles. The test taker’s task is to start with number one and draw a line from that circle to the circle with the number two in it to the circle with the three in it, etc. The person continues to connect the circles in numerical order until they reach number 25. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part A. This is a timed test and the number of seconds to complete the task is recorded.|baseline, 6 weeks, 12 weeks||||seconds||Standard Deviation|Mean
1256080|NCT00461981|Primary|Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects|Distribution of IFN-alpha/beta gene signature scores at 7 to 10 days after Dose 1. IFN alpha/beta gene signature scores were calculated as the average fold change in a panel of 21 type 1 IFN-inducible genes. The distribution of IFN alpha/beta gene signature scores ranged from -4 to 4, with -4 representing the lowest level of activity and 4 representing the highest level of activity. The percentage of subjects by IFN-alpha/beta gene signature score for each treatment group were compared.|Post Dose 1 (28 to 42 days post Dose 1)||||Units on a scale|||Number
1256472|NCT00459732|Primary|Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)||Baseline to 18 months|Intention to treat analysis in those who completed the 18 month timepoint (zinc vs. placebo)|||Percent change||Standard Deviation|Mean
1288238|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12||Month 12||||L||Standard Error|Mean
1256070|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Delayed Recall Scores.|"HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally.~The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall raw score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index.~These scores are for the delayed recall learning raw score. The HVLT-R delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
1256071|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Learning Scores.|"HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally.~The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index.~These results are for the HVLT-R total recall raw learning score. The HVLT-R total recall raw learning score ranges from 0 to 36 with 36 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
1256072|NCT00462072|Primary|Psoriasis Area and Severity Index (PASI) Delta|The PASI Delta for Ps subjects is a measure used to determine the change in the severity of an individual's disease with a positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 PASI Delta is determined by calculating the average change between the wk 0 and wk 10 PASI.|Week 10|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg|||Index Delta||Standard Deviation|Mean
1256073|NCT00462072|Primary|Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)|A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 PASI is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks.|Week 10|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg|||Index||Standard Deviation|Mean
1256074|NCT00462072|Primary|Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)|A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline PASI is an average of the study populations baseline disease activity score prior to the administration of infliximab (remicade). While higher PASI scores indicate more severe psoriasis, it is difficult for subjects or doctors to describe the clinical severity for any specific PASI number.|Baseline (Wk 0)|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg|||Index||Standard Deviation|Mean
1256075|NCT00462072|Primary|Disease Activity Score (DAS28) Delta|The DAS28 Delta for RA and PsA subjects is measure used to determine the change in the severity of an individual's disease with positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 DAS28 Delta is determined by calculating the average change between the wk 0 and wk 10 DAS28.|Week 10|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]|||Score Delta||Standard Deviation|Mean
1256076|NCT00462072|Primary|Week 10 Disease Activity Score (DAS28)|The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 DAS28 is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks. A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.|Week 10|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]|||Score||Standard Deviation|Mean
1256077|NCT00462072|Primary|Baseline (Wk 0) Disease Activity Score (DAS28)|The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline DAS28 is an average of the study populations baseline disease activity score prior to the administration of Infliximab (remicade). A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.|Baseline (Wk 0)|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]|||Score||Standard Deviation|Mean
1256078|NCT00462020|Secondary|Length of Stay, Charges, Adverse Events||1 month|||||||
1256081|NCT00461981|Primary|Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay|Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 35 days after Dose 2. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 35 days after Dose 2|Post Dose 2 (28 to 35 days post Dose 2)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and any post-Dose T-cell Elispot results (n=3; n=6)|||SPC/2 x 10^5 PBMCs||Full Range|Median
1256082|NCT00461981|Primary|Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay Following the First Dose|Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 42 days after Dose 1. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 42 days after Dose 1|Post Dose 1 (28 to 42 days post Dose 1)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and post-Dose 1 T-cell Elispot results (n=12; n=15)|||SPC/2 x 10^5 PBMCs||Full Range|Median
1256083|NCT00461981|Primary|Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay|Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 2|Post Dose 2 (7 to 10 days post Dose 2)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=10; n=9).|||Counts of ASCs per 10^6 PBMCs||Full Range|Median
1256084|NCT00461981|Primary|Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay|Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 1|Post Dose 1 (7 to 10 days post Dose 1)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=16; n=17).|||Counts of ASCs per 10^6 PBMCs||Full Range|Median
1256085|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).|||Titer||95% Confidence Interval|Geometric Mean
1256086|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).|||Titer||95% Confidence Interval|Geometric Mean
1256087|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).|||Titer||95% Confidence Interval|Geometric Mean
1256088|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).|||Titer||95% Confidence Interval|Geometric Mean
1256144|NCT00461734|Secondary|Echocardiographic Measures of Left Ventricular Dyssynchrony|No analysis has been done for this section since that variable was not collected during the study.|At 2-year follow-up|No analysis has been done for this section since that variable was not collected during the study||||||
1256145|NCT00461734|Secondary|Brain Natriuretic Peptide Levels (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available|||picograms per milliliter||Full Range|Median
1256146|NCT00461734|Secondary|Brain Natriuretic Peptide Levels (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available|||picograms per milliliter||Full Range|Median
1256089|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).|||Titer||95% Confidence Interval|Geometric Mean
1256090|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).|||Titer||95% Confidence Interval|Geometric Mean
1256091|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).|||Titer||95% Confidence Interval|Geometric Mean
1256092|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).|||Titer||95% Confidence Interval|Geometric Mean
1256093|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).|||Titer||95% Confidence Interval|Geometric Mean
1256094|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).|||Titer||95% Confidence Interval|Geometric Mean
1256095|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).|||Titer||95% Confidence Interval|Geometric Mean
1256096|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).|||Titer||95% Confidence Interval|Geometric Mean
1256147|NCT00461734|Secondary|Incidence of Stroke||At 5-year follow-up (study extension)||||participants|||Number
1256148|NCT00461734|Secondary|All Cause Mortality||At 5-year follow-up (study extension)||||participants|||Number
1256473|NCT00459732|Primary|Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)|Change in pa spine bone mineral density by DXA between baseline and 18 months|0 to 18 months|Intention to treat analysis of all subjects who completed the protocol in each arm of the study (zinc vs. placebo).|||Percent Change||Standard Deviation|Mean
1256097|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).|||Percentage of Participants|||Number
1256098|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).|||Percentage of Participants|||Number
1256099|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).|||Percentage of Participants|||Number
1256100|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).|||Percentage of Participants|||Number
1256101|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).|||Percentage of Participants|||Number
1256102|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).|||Percentage of Participants|||Number
1256103|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).|||Percentage of Participants|||Number
1256104|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).|||Percentage of Participants|||Number
1256149|NCT00461734|Secondary|Worsening of Heart Failure|"Worsening of heart failure can be defined as:~Heart failure-related hospitalization requiring intravenous heart failure therapy, or~Emergency department visit for heart failure requiring intravenous heart failure therapy, or~Any other visit in which the patient presents with signs or symptoms consistent with heart failure or heart failure exacerbation or marked decline in ejection fraction <35%, and intravenous heart failure therapy is required or titrate therapy.~CRT-P or CRT-D upgrade."|At 5-year follow-up (study extension)||||episodes|||Number
1256105|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).|||Percentage of Participants|||Number
1256106|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).|||Percentage of Participants|||Number
1256107|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).|||Percentage of Participants|||Number
1256108|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).|||Percentage of Participants|||Number
1256109|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).|||Titer||95% Confidence Interval|Geometric Mean
1256110|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).|||Titer||95% Confidence Interval|Geometric Mean
1256111|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).|||Titer||95% Confidence Interval|Geometric Mean
1256112|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29)|||Titer||95% Confidence Interval|Geometric Mean
1256150|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)||At 5-year follow-up (study extension)|Per Protocol Cohort with data available|||minutes per day||Standard Deviation|Mean
1256151|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)||At 5-years follow-up (study extension)|Intent to Treat Cohort with data available|||minutes per day||Standard Deviation|Mean
1256113|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).|||Titer||95% Confidence Interval|Geometric Mean
1256114|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).|||Titer||95% Confidence Interval|Geometric Mean
1256115|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).|||Titer||95% Confidence Interval|Geometric Mean
1256116|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).|||Titer||95% Confidence Interval|Geometric Mean
1256117|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).|||Titer||95% Confidence Interval|Geometric Mean
1256118|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).|||Titer||95% Confidence Interval|Geometric Mean
1256119|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2)for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).|||Titer||95% Confidence Interval|Geometric Mean
1256120|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).|||Titer||95% Confidence Interval|Geometric Mean
1256152|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available|||minutes per day||Standard Deviation|Mean
1256153|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available|||minutes per day||Standard Deviation|Mean
1272774|NCT00331760|Secondary|Chemotherapy Compliance for Cervical Carcinoma Patients||Chemotherapy treatment is centrally reviewed for quality assurance and compliance.|||||||
1256121|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).|||Percentage of Participants|||Number
1256122|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).|||Percentage of Participants|||Number
1256123|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).|||Percentage of Participants|||Number
1256124|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29).|||Percentage of Participants|||Number
1256125|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).|||Percentage of Participants|||Number
1256126|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).|||Percentage of Participants|||Number
1256127|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).|||Percentage of Participants|||Number
1256128|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).|||Percentage of Participants|||Number
1256154|NCT00461734|Primary|Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).||At 2-year follow-up|Per Protocol Cohort with data available|||percentage||Standard Deviation|Mean
1256155|NCT00461734|Primary|Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).||At 2-year follow-up|Intent to Treat Cohort with data available|||percentage||Standard Deviation|Mean
1272775|NCT00331760|Secondary|All Other Adverse Events||From start of treatment to the end of follow-up.|||||||
1256129|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).|||Percentage of Participants|||Number
1256130|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).|||Percentage of Participants|||Number
1256131|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).|||Percentage of Participants|||Number
1256132|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).|||Percentage of Participants|||Number
1256133|NCT00461851|Secondary|Best Reported Response|The best reported response captures the proportion of patients with advanced or metastatic transitional cell carcinoma of the bladder that achieve a complete or partial response to the combination therapy with sorafenib, gemcitabine, and carboplatin.|Upon completion of study||||Participants|||Count of Participants
1256134|NCT00461851|Secondary|Dose Ruction (Toxicity)|To determine the toxicity of combination therapy with sorafenib, gemcitabine and carboplatin, dose reductions by drug are reported. The number of patients that were reduced in dosage are reported here.|Upon completion of study|17 patients were evaluable for toxicity. A total of 77 cycles of gemcitabine/carboplatin were administered with a median 4.5 cycles per patient.|||Participants|||Count of Participants
1256135|NCT00461851|Primary|Progression Free Survival (PFS)|The primary outcome was the proportion of patients who achieved progression free survival (PFS) of five months. PFS was defined as time to progression or any-cause mortality, whichever came first.|Upon completion of study||||months||95% Confidence Interval|Median
1256136|NCT00461812|Primary|Efficacy as Assessed my Pulmonary Function Tests||change from baseline to study completion|There is no data available for this outcome measure. The study was prematurely terminated and the PI is no longer with the institution. The information available was obtained from the IRB.||||||
1256137|NCT00461786|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline until death from any cause up to 5-year follow-up||||months||Full Range|Median
1256138|NCT00461786|Secondary|Progression-Free Survival|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|baseline until documented tumor progression (up to 44 months)||||months||Full Range|Median
1256139|NCT00461786|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of initial response until documented tumor progression (up to 44 months)||||months||Full Range|Median
1256140|NCT00461786|Secondary|Number of Participants With Adverse Events by Grade|Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.|every 21-day cycle up to 5 year follow-up||||participants|||Number
1256141|NCT00461786|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 44 months)||||participants|||Number
1256142|NCT00461734|Secondary|6 Minute Hall-Walk Distance (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available|||meters||Inter-Quartile Range|Median
1256143|NCT00461734|Secondary|6 Minute Hall-Walk Distance (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available|||meters||Inter-Quartile Range|Median
1256156|NCT00461708|Secondary|Percentage of Participants With Disease Control According to RECIST|Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population|||percentage of participants|||Number
1256157|NCT00461708|Secondary|Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST|As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population|||percentage of participants|||Number
1256158|NCT00461708|Secondary|PFS|The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months|ITT population; only participants with an event (death or disease progression) were included in the analysis.|||months||95% Confidence Interval|Median
1256159|NCT00461708|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population|||participants|||Number
1256160|NCT00461708|Secondary|OS By Rash Grade|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population; only participants who died were included in the analysis.|||months||95% Confidence Interval|Median
1256161|NCT00461708|Secondary|Number of Participants Who Died During the Study By Rash Grade||Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population|||participants|||Number
1256162|NCT00461708|Secondary|OS At 6 Months|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 6 (4-week cycles), up to 6 months.|ITT population; only participants who died were included in the analysis.|||months||95% Confidence Interval|Median
1256163|NCT00461708|Secondary|Number of Participants Who Died at 6 Months||Enrollment through Cycle 6 (4-week cycles), up to 6 months.|ITT population|||participants|||Number
1256164|NCT00461708|Primary|Overall Survival (OS) During the Study|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population; only participants who died were included in the analysis.|||months||95% Confidence Interval|Median
1256165|NCT00461708|Primary|Number of Participants Who Died During the Study||Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population|||participants|||Number
1256166|NCT00461682|Secondary|Average Daily Pain Scores at Baseline (Pre-dose), 1, 2, 3, 4, 5 and 6h Post-dose for Each Treatment Period|"Individual pain scores were collected at screening and pre and post dose during the anorectal physiological assessments. Average daily pain scores as captured in participants' diary cards were summarized descriptively and analyzed. The 11 point pain intensity numerical rating scale ranges from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable”. This was used for the subjective assessment of the pain over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|At Baseline (pre-dose) and each hour post-dose of each treatment period|||||||
1256167|NCT00461682|Secondary|Symptom Scoring and Quality of Life Assessments Over Period|Different scales used in this study included HAD, BDI, SF36, Bristol Stool Scoring, IBS QOL and SSS that were used to rate different scores on respective scales. Untreated pain leads to a decrease in daily function capability, social stresses, loss of work, an overall poor quality of life and a burden on healthcare resources. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Approximately up to 3 months|||||||
1256168|NCT00461682|Secondary|Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) Calculated Over Approximately 10 Days Pre- and Post-dose|Participants were rated on a scale based on following parameters - Onset associated with change in the frequency and change in the appearance of stools, abnormal stool frequency (>3/day or < 3/week); abnormal stool form (lumpy/hard or loose/watery stool), abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus, and bloating were analyzed over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|10 days pre-dose and post-dose of each treatment period|||||||
1256539|NCT00459706|Secondary|Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept|"Percentage of participants answering Yes to the question Are you satisfied with your injection device?"|Day 28|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256169|NCT00461682|Secondary|Number of Defecations Over 24h and Over 1 Week Following a Dose of SB-705498 (Monitored Using Bristol Stool Scoring Diary Kept 1 Week Pre- and 1 Week Post-dose)|Onset associated with change in the frequency and change in the appearance of stools, abnormal stool frequency (>3/day or < 3/week); abnormal stool form (lumpy/hard or loose/watery stool), abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus, and bloating were analyzed over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|7 days pre-dose and 7 days post-dose of each treatment period|||||||
1256170|NCT00461682|Secondary|Contact Heat-evoked Potentials (CHEPs) – Optional, Assessed Pre-dose and 6h Post-dose of Each Treatment Period|For heat pain threshold measurement, temperature of the thermode was gradually increased from the baseline (32°C) at a rate of 1°C/s. The ramp was stopped and the temperature of the thermode was returned to the Baseline. This was repeated three times. The threshold temperatures and the average value were recorded by the computer. If the thermode temperature reached 50°C without the participant responding, the ramp was stopped and the temperature was returned to baseline automatically to prevent skin injury. This test was performed within two minutes. The respective cut-off temperature is then recorded for that trial. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Baseline (pre-dose) and 6h post-dose of each treatment period|||||||
1256171|NCT00461682|Secondary|Somatic Heat Pain Thresholds (Hand and Foot) Assessed Pre-dose and 6h Post-dose of Each Treatment Period|Evoked potentials were to be recorded from midline electrodes by placing a ground electrode on temporal lobe region. A low cut off filter with a time constant of 1.06103 and a frequency of 0.15 hertz (Hz) and a high cut off filter of 100Hz was to be applied. The impedance from all electrodes was maintained below 5 ohms (Ω) and the electroencephalogram (EEG) was recorded, digitized at a sampling rate of 500 Hz. Responses from ten stimuli were to be recorded from each participant with the thermode placed over foot and one hand (non-dominant side). The thermode heating rate was set at 70 degree Celsius per second (°C/s) and the cooling rate at 40°C/s. The baseline temperature was 32 °C, destination temperature 51 °C, and stimulus interval approximately of 7 seconds. The participants were allowed to withdraw any time. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Baseline (pre-dose) and upto 0-6h post-dose for each treatment period|||||||
1256172|NCT00461682|Secondary|Pain Intensity Difference (SPID6), as Derived From Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h Post-dose of Each Treatment Period|"Change from Baseline (pre-dose0 is the value at indicated time point minus the Baseline value. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable” was planned to be used for the subjective assessment of the pain. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|Baseline (pre-dose) and up to 0-6 h post-dose of each treatment period|||||||
1256173|NCT00461682|Secondary|Peak Pain Intensity Difference (PPID6), as Derived From Maximum Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h of Each Treatment Period|"No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Change from Baseline (pre-dose) is the value at indicated time-point minus the Baseline value. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable” was planned to be used for the subjective assessment of the pain."|Baseline (pre-dose) and up to 0-6 h of each treatment period|||||||
1256174|NCT00461682|Secondary|Rectal Sensory Thresholds to Thermal Stimulation (Contact Heat Device, Values Reported as in Study) at Pre-dose and 6h Post-dose of Each Treatment Period|Visceral hypersensitivity is defined as reduced pain and discomfort threshold to rectal stimuli. Rectal hypersensitivity was correlated with the degree of rectal hypersensitivity (up-regulation of TRPV-1 receptors) as measured by rectal thermal stimulation. Ongoing rectal pain intensity scale is 11-point numeric rating scale, where 0=Unnoticeable/No Pain, 10=Unbearable/Worst Pain. An average of daily scores over 1 week pre-dose and 1 week post-dose was recorded. Single measurements pre-dose and at hourly intervals within 6 hours post-dose were also recorded. Participants were planned to stay in the hospital for 6h post-dose and were planned to be discharged when physician was satisfied with their medical condition. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge.|Baseline (pre-dose) and 6h post-dose of each treatment period|||||||
1256175|NCT00461682|Secondary|Visual Analogue Scores for Rectal Distensions for Gas, Urgency to Defecate and Discomfort at Pre-dose and 6 h Post-dose of Each Treatment Period|"The VAS scores for assessment of rectal sensation for pain, gas, urgency and discomfort were analyzed separately. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable” was planned to be used for the subjective assessment of the pain. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|Baseline (pre-dose) and up to 6 h post-dose of each treatment period|||||||
1256193|NCT00461500|Secondary|Change From Baseline in Overall Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|7-point scale where 1=total impairment and 7=no impairment. Questions contain 32 items in four domains. Domains include Activity Limitation (11 items), Symptoms (12 items), Emotional Function (5 items), and Environmental Stimuli (4 items). 32 items produce one overall quality of life score. The 7 points scoring are different and depend on the item : they are the translation in French of the original questionnaire from Juniper. Possible AQLQ scores range from 1 to 7 (the mean of all the questions).|Baseline, Week 12|Intent-to-Treat population.|||Score on a scale||Standard Deviation|Mean
1256176|NCT00461682|Primary|Visual Analogue Scale (VAS) Pain Score to Rectal Distensions at Pre-dose and up to 6 Hours (h) Post-dose of Each Treatment Period|"This analysis was performed at 12, 24, 36 and 48 millimeters of mercury (mmHg) which was above the baseline operating pressure threshold. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents “No pain and 10 represents “Worst pain imaginable” was planned to be used for the subjective assessment of the pain."|Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period|||||||
1256177|NCT00461630|Secondary|Mortality|All-cause mortality|During scheduled treatment period (median duration 3.9 years)||||participants|||Number
1256178|NCT00461630|Secondary|Coronary or Non-coronary Revascularisation||During scheduled treatment period (median duration 3.9 years)||||participants|||Number
1256179|NCT00461630|Secondary|Stroke|Fatal or non-fatal|During scheduled treatment period (median duration 3.9 years)||||participants|||Number
1256180|NCT00461630|Secondary|Major Coronary Events|Non-fatal myocardial infarction (MI) or coronary death|During scheduled treatment period (median duration 3.9 years)||||participants|||Number
1256181|NCT00461630|Primary|Major Vascular Event|Non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation|During scheduled treatment period (median duration 3.9 years)||||participants|||Number
1256182|NCT00461591|Secondary|Overall Survival|The number of months from randomization to death from any cause.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1256183|NCT00461591|Secondary|Disease Free Survival|The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1256184|NCT00461591|Secondary|Disease Free Interval|The number of months from randomization to histologically confirmed progression of the patient’s bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1256185|NCT00461591|Secondary|Number of Recurrences Per Patient|The number of histologically confirmed recurrences during the course of the study.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||times||Standard Deviation|Mean
1256186|NCT00461591|Secondary|Time to Progression|The number of months from randomization to progression to either a higher stage or grade of the patient’s bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1256187|NCT00461591|Secondary|Progression Rate at 2 Years|The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||Participants|||Count of Participants
1256188|NCT00461591|Secondary|Time to Recurrence|The number of months from randomization to histologically confirmed recurrence of the patient’s bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
1256189|NCT00461591|Primary|Recurrence Rate at 2 Years|The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||Participants|||Count of Participants
1256190|NCT00461513|Secondary|Hospitalization at 1 Year|Hospitalization at 1 year|12 months||||Participants|||Count of Participants
1256191|NCT00461513|Secondary|Mortality at 1 Year|Mortality at 1 year|12 months||||Participants|||Count of Participants
1256192|NCT00461513|Primary|Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.|The primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. This is reported for each group (Intervention and Usual Care). The average for each group and standard deviation are reported. A positive score change represents an improvement in overall patient health status for the group of patients with congestive heart failure. A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.|12 months||||units on a scale||Standard Deviation|Mean
1256194|NCT00461500|Secondary|ACT Score in Classes at Week 12|Score is ranged from 5 (poor control) to 25 (complete control).|Week 12|Intent-to-Treat population.|||Particpants|||Number
1256628|NCT00458406|Secondary|Change in NOSE Scale Score From Month 1 to Month 3|Change in the total Nasal Obstruction Symptom Evaluation (NOSE) scale score (Score at Month 3 minus Score at Month 1). This scale evaluates the severity of nasal obstructive symptoms. The scale ranges from 0-20, with a higher score indicating more nasal obstruction.|3 months||||units on a scale||Standard Deviation|Mean
1256195|NCT00461500|Secondary|Change From Baseline in Asthma Control Test (ACT) Score at Week 12|5 question test with various responses rating frequency of asthma events over 4-week period. Questions include occurrence of asthma affecting work/school; causing shortness of breath; symptoms (wheezing, coughing, shortness of breath, chest tightness, pain) wake you up at night; causing need for rescue medication; asthma control. Scale: 1=all of time, 2=most of time, 3=some of the time, 4=a little of the time, 5=none of the time. Possible ACT scores range from 5 to 25.|Baseline, Week 12|Intent-to-Treat population.|||Score on a scale||Standard Deviation|Mean
1256196|NCT00461500|Secondary|Number of Participants Who Achieved Total-controlled Asthma During Weeks 5-12|"Totally-controlled asthma is defined as no daily symptoms, no night-time awakenings, no exacerbations, no rescue medication, no emergency visits, no treatment related adverse events resulting in change in asthma therapy, >=80% predicted PEF. The number of subjects who achieved total-controlled asthma at any time during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 - 12|Intent-to-Treat population.|||Participants|||Number
1256197|NCT00461500|Secondary|Median Number of Weeks to First Achieve Well-Controlled Asthma During Weeks 5-12|"Well-controlled asthma is defined as 2 or more of the following: symptoms on no more than 2 days with symptom score of >1; no more than 2 days of rescue meds (maximum of 4 per week); >=80% predicted morning PEF. And no night time awakenings, exacerbations, emergency room visits, and treatment related adverse effects requiring a change to therapy. The median number of weeks to first achieve well-controlled asthma during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 - 12|Intent-to-Treat population.|||Weeks||Full Range|Median
1256198|NCT00461500|Secondary|Number of Participants Who Achieved Well-Controlled Asthma During Weeks 5-12|"Well-controlled asthma is defined as 2 or more of the following: symptoms on no more than 2 days with symptom score of >1; no more than 2 days of rescue meds (maximum of 4 per week); >=80% predicted morning PEF. And no night time awakenings, exacerbations, emergency room visits, and treatment related adverse effects requiring a change to therapy. The number of participants who achieved well-controlled asthma at any time during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 -12|Intent-to-Treat population.|||Participants|||Number
1256199|NCT00461500|Secondary|Number of Participants With at Least One Exacerbation During 12-Week Treatment Period|Subjects will record exacerbations (defined as temporary PEF decrease, increase in salbutamol use) in a Daily Record Card (DRC). The number of events are categorized as those that showed a deterioration in asthma requiring administration of oral corticosteroids and/or a deterioration in asthma requiring emergency room visit and/or hospitalization (hosp.).|12-Week Treatment Period (Week 1 through Week 12)|Intent-to-Treat population.|||Participants|||Number
1256200|NCT00461500|Secondary|Change From Baseline (BL) in Pre-dose FEF 25-75% (Forced Expiratory Flow) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Forced Expiratory Flow 25-75% (measured by a spirometer) is the average flow (or speed) of air coming out of the lung during the middle portion of the expiration. Age, height, and gender is used to determine what is normal. Change from BL could have been measured at any time during the study (up to Week 12), using the LOCF (for each individual, missing values are replaced by the last observed value of that variable). Change from BL is measured as percentage of predicted value, with height, gender, age, and race as variables (percentage of predicted value at endpoint minus value at BL).|Baseline through Week 12|Intent-to-Treat population.|||Percentage of predicted value||Standard Deviation|Mean
1256201|NCT00461500|Secondary|Change From Baseline in Pre-dose Forced Expiratory Vital Capacity (FVC) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|FVC is the total amount of air that can forcibly be blown out after full inspiration, measured in liters. A spirometer is the device used to measure FVC. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat|||Liters||Standard Deviation|Mean
1256202|NCT00461500|Secondary|Change From Baseline in FEV1 Reversibility Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Reversibility is calculated as the percentage improvement of FEV1 from baseline. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable. Percent reversibility of FEV1 was calculated as follows: (Post-bronchodilator FEV1 – pre-bronchodilator FEV1)/pre-bronchodilator FEV1 x 100. A negative difference indicates less reversibility.|Baseline through Week 12|Intent-to-Treat population.|||Percent change||Standard Deviation|Mean
1256203|NCT00461500|Secondary|Change From Baseline in Pre-dose (Percent Predicted) FEV1 Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Percent predicted is based on tables of normal values that use variables such as age, gender, and weight as a method of standardization. Spirometry results are expressed as a percentage, and are generally considered abnormal if less than 80 percent of the normal predicted value. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat population.|||Percentage predicted of FEV1||Standard Deviation|Mean
1256204|NCT00461500|Secondary|Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|FEV1 is the amount of air (in liters) you can blow out within one second. A spirometer is the device used to measure FEV1. With normal lungs and airways you can normally blow out most of the air from your lungs within one second. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat population.|||Liters||Standard Deviation|Mean
1256234|NCT00461305|Secondary|Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
1256205|NCT00461500|Primary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12|Mini Wright Peak Flow Meter used to allow patients to monitor their asthma - Peak Flow (or PEF - peak expiratory flow) is a measurement of how fast you can blow out. When someone is well, their PEF is higher - when the airways are narrow (as in asthma), PEF is lower. Readings based on age, height and gender.|Baseline, Weeks 5-12|Intent-to-Treat population are all randomized patients having received one study drug dose and had at least one complete efficacy assessment.|||Liters per minute (L/min)||Standard Deviation|Mean
1256206|NCT00461331|Secondary|Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place|Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.|Between 48, 72 and 96 hours after the last pump infusion line change||||pg/ml||Standard Deviation|Mean
1256207|NCT00461331|Secondary|Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place|Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.|48 to 100 hours after keeping the same pump infusion line in place||||µg/ml||Standard Deviation|Mean
1256208|NCT00461331|Primary|Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change|For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level >300 mg/dL.|24 to 100 hours after last pump infusion line change|The analysis was per protocol, intention to treat. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin.|||Participants|||Number
1256209|NCT00461305|Post-Hoc|Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Baseline and up to Cycle 13 (364 days) with 28 days per cycle|FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||scores on a scale||Standard Deviation|Mean
1256210|NCT00461305|Post-Hoc|Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Baseline and up to Cycle 6 (168 days) with 28 days per cycle|FAS|||scores on a scale||Standard Deviation|Mean
1256211|NCT00461305|Secondary|Change in Serum CRP From Baseline to Cycle 13|CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||mg/dL||Full Range|Mean
1256212|NCT00461305|Secondary|Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6|CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS(Participants with data at Cycle 6)|||mg/dL||Full Range|Mean
1256213|NCT00461305|Secondary|Change in Serum CA-125 From Baseline to Cycle 13|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||Units/mL||Full Range|Mean
1256214|NCT00461305|Secondary|Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS(Participants with data at Cycle 6)|||Units/mL||Full Range|Mean
1256215|NCT00461305|Secondary|Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||Percentage of participants|||Number
1256216|NCT00461305|Secondary|Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||Percentage of participants|||Number
1256217|NCT00461305|Secondary|Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||Percentage of participants|||Number
1256218|NCT00461305|Secondary|Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||Percentage of participants|||Number
1256219|NCT00461305|Secondary|Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256681|NCT00458211|Secondary|Cholesterol||8 weeks|See PANSS above|||mg/dL||Standard Deviation|Mean
1256682|NCT00458211|Secondary|Fasting Glucose||8 weeks|See PANNS above|||mg/dl||Standard Deviation|Mean
1256683|NCT00458211|Secondary|Weight||8 weeks|Same as PANNS above|||pounds||Standard Deviation|Mean
1256220|NCT00461305|Secondary|Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||participants|||Number
1256221|NCT00461305|Secondary|Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256222|NCT00461305|Secondary|Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||participants|||Number
1256223|NCT00461305|Secondary|Number of Any Bleeding Days From Cycle 1 to Cycle 13|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||days||Full Range|Mean
1256224|NCT00461305|Secondary|Number of Any Bleeding Days From Cycle 1 to Cycle 6|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||days||Full Range|Mean
1256225|NCT00461305|Secondary|Number of Any Bleeding Episodes From Cycle 1 to Cycle 13|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||number of episodes||Full Range|Mean
1256226|NCT00461305|Secondary|Number of Any Bleeding Episodes From Cycle 1 to Cycle 6|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||number of episodes||Full Range|Mean
1256227|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||scores on a scale||Full Range|Mean
1256228|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||scores on a scale||Full Range|Mean
1256229|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||scores on a scale||Full Range|Mean
1256230|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||scores on a scale||Full Range|Mean
1256231|NCT00461305|Secondary|Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256232|NCT00461305|Secondary|Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
1256233|NCT00461305|Secondary|Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256235|NCT00461305|Secondary|Distribution of Severity of Headache During Menstruation at Cycle 13|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256236|NCT00461305|Secondary|Distribution of Severity of Headache During Menstruation at Cycle 6|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
1256237|NCT00461305|Secondary|Distribution of Severity of Lumbago During Menstruation at Cycle 13|Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256238|NCT00461305|Secondary|Distribution of Severity of Lumbago During Menstruation at Cycle 6|Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
1256239|NCT00461305|Secondary|Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256240|NCT00461305|Secondary|Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
1256241|NCT00461305|Secondary|Distribution of Total Dysmenorrhea Score at Cycle 13|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256242|NCT00461305|Secondary|Distribution of Total Dysmenorrhea Score at Cycle 6|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
1256243|NCT00461305|Secondary|Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
1256244|NCT00461305|Secondary|Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
1256245|NCT00461305|Primary|Number of Participants With Intracyclic Bleeding at Cycle 6|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
1256246|NCT00461292|Secondary|Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire|Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients’ lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)|||Number on a Scale (Score)||Standard Deviation|Mean
1256247|NCT00461292|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during the first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)|||Centimeters of water (cm H2O)||Standard Deviation|Mean
1256248|NCT00461292|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at Week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)|||Milliliters (mL) of urine||Standard Deviation|Mean
1263812|NCT00407537|Secondary|Mean Systolic and Diastolic Blood Pressure at Month 4||Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.|||mmHg||Standard Deviation|Mean
1256249|NCT00461292|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)|||Number of Weekly Episodes||Standard Deviation|Mean
1256250|NCT00461253|Primary|Breast Cancer Risk|Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.|retrospective, January 2000 to December 2007|Frequency of breast cancer (in situ and invasive) in LNG-IUD users and Cu-IUD users|||participants|||Number
1256251|NCT00461175|Other Pre-specified|Contraceptive Failure|Intrauterine contraceptive methods have low Pearl Indices. Nevertheless, there is a lack of comparative data between LNG IUS users and copper IUD users. Women with unintended pregnancies were explicitly aked whether the pregnancy occured despite IUD use. The 29 pregnancies that occured after unrecognized IUD expulsion were considered to have resulted from a failure of the contraceptive method and were therefore included in the analysis.|Within 12 months||||participants|||Number
1256252|NCT00461175|Primary|Uterine Perforation Rate|Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The absolute risk of uterine perforation associated with the LNG IUS in routine medical practice has not hitherto been well defined. It is also unknown whether the perforation rate is higher with this IUD than with copper IUDs.|12 months after insertion|"Intention-to-treat (ITT) population. Number of Participants referring to the initially inserted IUS/IUD or the initial IUD insertion attempt."|||participants|||Number
1256253|NCT00461123|Secondary|Duration of Surgery|Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery.|on the day of surgery, without any further allowable time window|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of duration of surgery; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."|||minutes||Standard Deviation|Mean
1256254|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline documentation of number of incontinence episodes per week; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."|||urinary incontinence episodes||Standard Deviation|Mean
1256255|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of post-void residual (PVR) volume; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."|||milliliter (mL)||Standard Deviation|Mean
1256256|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst).|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of International Prostate Symptom Score (IPSS) total score; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."|||scores on a scale||Standard Deviation|Mean
1256257|NCT00461123|Primary|Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of peak urinary flow; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study, as displayed under Participants Flow."|||milliliter per second (mL/s)||Standard Deviation|Mean
1256258|NCT00461097|Secondary|Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid|Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment.|4 years (48 months)||||percentage of participants|||Number
1256259|NCT00461097|Secondary|Number of Participants With Serious Adverse Events (SAEs)|This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.|Baseline through the 2-year primary endpoint|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||participants|||Number
1256405|NCT00460434|Primary|Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence|Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.|3 months post-surgery||||Participants|||Count of Participants
1256260|NCT00461097|Secondary|Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg|For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose.|Following the blinded desensitization phase at approximately Week 44|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||percentage of participants|||Number
1256261|NCT00461097|Secondary|Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation|On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur.|Initial day of dosing|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||percentage of participants|||Number
1256262|NCT00461097|Secondary|Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid|Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes.|Following the blinded desensitization phase at approximately Week 44|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||percentage of participants|||Number
1256263|NCT00461097|Primary|Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes.|At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||percentage of participants|||Number
1256264|NCT00461045|Secondary|Maximum Observed Blood Drug Concentration (Cmax)||Samples collected on Cycle 1 Day 1 and Cycle 1 Day 11.|The sponsor elected not to analyze the pharmacokinetic (PK) samples collected, therefore, no PK results are obtained.||||||
1256265|NCT00461045|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|"Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug.~Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship."|Through study completion, an average of 6.09 weeks.||||TEAEs|||Number
1256266|NCT00461045|Secondary|Number of Patients With Treatment Emergent Adverse Events (TEAEs)|"Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug.~Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship."|Through study completion, an average of 6.09 weeks.||||Participants|||Count of Participants
1256267|NCT00461045|Secondary|Number of Patients Receiving Marizomib (MRZ) in Each Cycle|A patient was counted in a cycle if the patient received at least one dose of study drug during the cycle.|Through study completion, an average of 6.09 weeks.||||Participants|||Count of Participants
1256268|NCT00461045|Secondary|Number of Cycles of Marizomib (MRZ)||Through study completion, an average of 6.09 weeks.||||cycles||Standard Deviation|Mean
1256269|NCT00461045|Secondary|Duration of MRZ Treatment|Duration of treatment is defined as the last dose date minus the first dose date of the dose cohort plus 1 expressed in weeks.|Through study completion, an average of 6.09 weeks.||||weeks||Standard Deviation|Mean
1256270|NCT00461045|Primary|Number of Patients Exhibiting a Given Overall Response as Determined by Investigator|Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.|Through study completion, an average of 6.09 weeks.||||participants|||Number
1256271|NCT00461032|Secondary|Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants|Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.|8 Week treatment period initiated at the beginning of a school year|The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. Variables that were measured as the average over the treatment period were defined from at least 7 days of evaluable diary data.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1256272|NCT00461032|Secondary|Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants||8 Week treatment period initiated at the beginning of a school year|The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had valid efficacy measurement for at least 7 days of diary data.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1256273|NCT00461032|Secondary|Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)|Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.|8 Week treatment period initiated at the beginning of a school year|The analysis was based on the FAS population. This included all randomized participants who received at least 1 dose of study medication and had a valid efficacy measurement. Occurrence of one or more health care utilization was derived from the available diary data and was set to missing if no diary data were available.|||Participants|||Number
1256684|NCT00458211|Secondary|Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.|CGI-S scores from 1 = normal to 7 = most extremely ill|8 weeks|17 Buffalo subjects and 19 Bronx subjects|||score on scale||Standard Deviation|Mean
1256274|NCT00461032|Primary|Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants|"A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake all night; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization."|8 Week treatment period initiated at the beginning of a school year|The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1256275|NCT00460993|Primary|Sleep Efficiency|Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time|6 days||||percentage of sleep||Full Range|Median
1256276|NCT00460811|Secondary|Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period|During the study, patients provided their self assessment of abdominal pain using a 5-point ordinal scale (1=none, 2=mild, 3=moderate, 4=severe, 5=very severe|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).|||units on a scale||Standard Error|Least Squares Mean
1256277|NCT00460811|Secondary|Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period|Patients provided a weekly assessment of Degree of Relief of IBS Symptoms using a 7-point balanced scale (1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse, 7=as bad as I can imagine).|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 13 patients who dropped out prior to finishing 1 week of the trial have missing data.|||units on a scale||Standard Error|Least Squares Mean
1256278|NCT00460811|Secondary|Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period|Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 15 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis.|||units on a scale||Standard Error|Least Squares Mean
1256279|NCT00460811|Secondary|Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period|Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (difficult to pass); 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = watery, no solid pieces (entirely liquid).|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 15 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis.|||units on a scale||Standard Error|Least Squares Mean
1256280|NCT00460811|Secondary|Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period|SBMs were measured daily during the treatment period by patient calls to the IVRS.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).|||SBMs per week||Standard Error|Least Squares Mean
1256281|NCT00460811|Secondary|CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|For each week of the Treatment and Posttreatment Periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥ 4 days of IVRS questions, 2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from the baseline weekly CSBM rate.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).|||participants|||Number
1256282|NCT00460811|Primary|Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period|"The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period.~The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours."|Change from Baseline to Week 12|The Intent-to-treat (ITT) Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency)|||CSBMs per week||Standard Error|Least Squares Mean
1256283|NCT00460798|Primary|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores|EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/quality of life (QoL) scale, 3 symptom scales (nausea and vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range=0 to 100. High score for a functional scale=high/healthy level of functioning. High score for global health status/QoL=high QoL. High score for symptom scale/single item=high level of symptomatology/problems|Baseline, 3, 6, 9 and 12 Months|FAS. n=number of participants with EORTC scale score data available at each specified time point|||Scores on Scale||Standard Deviation|Mean
1256387|NCT00460525|Primary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence that results in death, is life threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization or is a congenital anomaly/birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above was considered serious.|24 months after initial vaccination||||Participants|||Number
1256284|NCT00460798|Primary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status|Baseline, 3, 6, 9 and 12 Months|FAS. ECOG performance status data was not reported for 24, 32, 96, 174, and 174 participants at baseline, 3, 6, 9, and 12 months, respectively.|||Participants|||Number
1256285|NCT00460798|Primary|Time to Progression (TTP)|TTP = time from date of first dose to date of first recording of PD. Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.|Start of Treatment up through 12 Months or Early Discontinuation|FAS. Number of participants with progression = 162; Number of participants censored = 190|||Months||95% Confidence Interval|Median
1256286|NCT00460798|Primary|Number of Participants With Objective Response|Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|12 Months or Early Discontinuation|FAS|||Participants|||Number
1256287|NCT00460798|Primary|Number of Participants With Categorical Best Overall Response|Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|Start of Treatment up through 12 Months or Early Discontinuation|Full Analysis Set (FAS) = All participants who had taken at least 1 dose of study medication and had a post baseline efficacy measurement|||Participants|||Number
1256288|NCT00460746|Secondary|Median Change From Baseline in Glucose at Week 48.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
1256289|NCT00460746|Secondary|Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.||Week 48|ITT , LOCF.|||ratio of TC and HDL||Full Range|Median
1256290|NCT00460746|Secondary|Median Change From Baseline in HDL Cholesterol.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
1256291|NCT00460746|Secondary|Median Change From Baseline in LDL Cholesterol at Week 48.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
1256292|NCT00460746|Secondary|Median Change From Baseline in Total Cholesterol at Week 48.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
1256293|NCT00460746|Secondary|Median Change From Baseline in Triglycerides at Week 48.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
1256294|NCT00460746|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.||Week 48|ITT , LOCF.|||cells/mm^3||Standard Deviation|Mean
1256295|NCT00460746|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.||Week 48|Intent To Treat (ITT), last observation carried forward (LOCF).|||cells/mm^3||Full Range|Median
1256296|NCT00460746|Secondary|Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.||48 weeks|ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.|||percentage of participants|||Number
1256297|NCT00460746|Primary|Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.||48 weeks|ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.|||percentage of participants|||Number
1256298|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256299|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256388|NCT00460525|Primary|Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.|Time to first clinical malaria episode is displayed in a life table format to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point.|Occurring between randomization and 6 months after the assigned date of the 3rd immunization.||||Participants|||Number
1288239|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12||Month 12||||L||Standard Error|Mean
1256300|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256301|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The time (seconds) required to walk 10 meters was measured at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||seconds||Standard Deviation|Mean
1256302|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256303|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to Week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256304|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256305|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256306|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256307|NCT00460655|Secondary|Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase|The time (seconds) required to walk 10 meters was measured at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||seconds||Standard Deviation|Mean
1256308|NCT00460655|Secondary|Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase|The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point in double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1256309|NCT00460655|Secondary|Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
1288240|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6||Month 6||||L||Standard Error|Mean
1256310|NCT00460655|Primary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12)|Change from baseline in MAS ankle score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS ankle score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS ankle score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Score*week||Standard Deviation|Mean
1256311|NCT00460603|Secondary|Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2|PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was “at its worst”. Each item is scored from 0 to 10, with ‘0’ indicating that the symptom was either not present or did not interfere with their activities, and ‘10’ indicating that the symptom was “as bad as you can imagine” or “interfered completely” with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms.|Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||units on scale||Standard Deviation|Mean
1256312|NCT00460603|Secondary|Overall Survival (OS): Phase 2|Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant|ITT population included all randomized participants , with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||days||95% Confidence Interval|Median
1256313|NCT00460603|Secondary|Time to Treatment Failure (TTF): Phase 2|TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||days||95% Confidence Interval|Median
1256314|NCT00460603|Secondary|Progression-Free Survival (PFS): Phase 2|"Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation."|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||days||95% Confidence Interval|Median
1256315|NCT00460603|Secondary|Duration of Response (DR): Phase 2|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: >=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. 'N' (Number of participants analyzed)= those participants who were evaluable for this measure.|||days||95% Confidence Interval|Median
1256406|NCT00460421|Secondary|Long-Term Follow-Up: Overall Survival|Overall survival was defined as the number of days from the date of first investigational product administration to the date of death (regardless of cause)|Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||months||Full Range|Median
1256316|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
1256317|NCT00460603|Secondary|Clearance (CL) For Bevacizumab: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||95% Confidence Interval|Geometric Mean
1256318|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1||Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
1256319|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1|PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
1256320|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256321|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256322|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
1256323|NCT00460603|Secondary|Clearance (CL) For Irinotecan: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||95% Confidence Interval|Geometric Mean
1256324|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1||Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
1256325|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1|Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
1256326|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256327|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256328|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
1256329|NCT00460603|Secondary|Clearance (CL) For 5-Fluorouracil: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||95% Confidence Interval|Geometric Mean
1256330|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1||Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
1256331|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1|PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
1256332|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256333|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256370|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase|DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256334|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
1256335|NCT00460603|Secondary|Clearance (CL) For Oxaliplatin: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||95% Confidence Interval|Geometric Mean
1256336|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1||Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
1256337|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1|PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
1256338|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256339|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256340|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
1256341|NCT00460603|Secondary|Apparent Oral Clearance (CL/F) For Axitinib: Phase 1|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
1256342|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1||Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
1288241|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6||Month 6||||L||Standard Error|Mean
1256343|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1|PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
1256344|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1256345|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram hour per milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
1256346|NCT00460603|Primary|Percentage of Participants With Objective Response: Phase 2|Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|Intent-to-treat (ITT) population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1256347|NCT00460577|Primary|Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||score on a scale||Standard Deviation|Mean
1256348|NCT00460577|Primary|Mean Change in Pulse Oxymetry From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.|Baseline, 4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||percentage||Standard Deviation|Mean
1256349|NCT00460577|Primary|Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||Liters||Standard Deviation|Mean
1256350|NCT00460577|Secondary|Pharmacoeconomic Analysis|Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.|4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||Cost in US Dollars||Full Range|Mean
1256351|NCT00460577|Secondary|Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events|Not posted: see comment in Limitations and Caveats.|4 hours|||||||
1256352|NCT00460577|Primary|Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||Liters/minute||Standard Deviation|Mean
1256386|NCT00460525|Secondary|Incidence Density of Clinical Malaria Episode|Clinical malaria episode was defined by significant parasitemia (2500/mm^3) and temperature of greater than or equal to 37.5 degrees C. Event rate was determined by dividing the number of episodes (150 for the Rabies group and 121 for the FMP2.1/ASO2A group) by the number of Person Years at Risk (PYAR) (126.341 for Rabies group and 127.411 for the FMP2.1/ASO2A group).|Between randomization and 6 months after 3rd immunization.|Analyses are ITT.|||Events Per PYAR|||Number
1256353|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256354|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256355|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256356|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Limb Posture at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Weeks 12 to 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256357|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Dressing at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256358|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Pain at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256359|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Hygiene at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability; 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256389|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after third vaccination|All subjects receiving the vaccination are included.|||Adverse Events|||Number
1256360|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Principal Measure at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256361|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Finger Score From at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the MAS finger score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256362|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Wrist Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the MAS wrist score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=no increase in muscle tone to 4=affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder ([less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256363|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256364|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256365|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256366|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase|DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256367|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase|DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256368|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase|DAS score of pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256369|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase|DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256436|NCT00460239|Primary|Physiologic Effects as Assessed by Heart Rate||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||beats/min||Standard Deviation|Mean
1256371|NCT00460564|Secondary|Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed MAS finger score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256372|NCT00460564|Secondary|Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed MAS wrist score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
1256373|NCT00460564|Secondary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the Low-dose Groups|Change from baseline in MAS wrist score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis (HA) and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the area under the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Score*week||Standard Deviation|Mean
1256374|NCT00460564|Primary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the High-dose Groups|Change from baseline in MAS wrist score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Score*week||Standard Deviation|Mean
1256375|NCT00460551|Primary|Progression Free Survival Verified by Imaging Techniques.|Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16|Until disease progression|Data was not collected. Imaging scans were not taken during part 1A. The trial was prematurely closed when 13 patients were enrolled in part 1A. Scans were planned for part 1B and 2. No patients continued to part 1B and part 2.|||Participants|||Number
1256376|NCT00460551|Secondary|Adverse Events|Number of participants reporting at least one adverse event|Up to 3 months|Number of patients reporting at least one adverse event|||participants|||Number
1256377|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 730|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 730.|Day 730 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256378|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 547|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 547.|Day 547 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256379|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 364|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 364.|Day 364 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256380|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 240.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 240.|Day 240 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256381|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 150.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 150.|Day 150 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256382|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 90.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 90.|Day 90 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256383|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 60.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 60, prior to the third vaccination.|Day 60 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256384|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 30.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 30, prior to the second vaccination.|Day 30 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256385|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by Enzyme Linked ImmunoSorbent Assay (ELISA) at Day 0|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 0 prior to the first vaccination.|Day 0|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
1256390|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after second vaccination|All subjects receiving the vaccination are included.|||Adverse Events|||Number
1256391|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after first vaccination|All subjects receiving the vaccination are included.|||Adverse Events|||Number
1256392|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after the third vaccination|All subjects receiving the vaccination are included.|||Participants|||Number
1256393|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after the second vaccination|All subjects receiving the vaccination are included.|||Participants|||Number
1256394|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after each vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after first vaccination|All subjects receiving the vaccination are included.|||Participants|||Number
1256395|NCT00460434|Secondary|Incontinence Severity Index|Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.|Baseline, 3 months, and 12 months post-surgery|Women who completed the Incontinence Severity Index survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
1256396|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Stress Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI stress subscale survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
1256397|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Irritative Symptom Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI irritative symptom subscale survey at baseline and 3 months after the index surgery.|||units on a scale||Standard Deviation|Mean
1256398|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Obstructive Symptom Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI obstructive symptom subscale survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
1256399|NCT00460434|Secondary|Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)|PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the PFDI UDI survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
1256400|NCT00460434|Secondary|Treatment for Incontinence|The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.|3 months post-surgery|Women who reported whether or not they needed treatment for any urinary incontinence.|||Participants|||Count of Participants
1256401|NCT00460434|Secondary|Symptoms of Incontinence|Symptoms that were at least moderately bothersome to the participant (as measured by a response of “moderately” or “quite a bit” to any of the four items on the Pelvic Floor Distress Inventory regarding leakage).|3 and 12 Months Post-surgery|Women who completed questions in the Pelvic Floor Distress Inventory regarding leakage 3 and 12 months after their index surgery.|||Participants|||Count of Participants
1256402|NCT00460434|Secondary|Positive Cough Stress Test|A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.|3 and 12 Months Post-surgery|Women who came in for 3 and 12 month post-op office visits and completed a cough stress test.|||Participants|||Count of Participants
1256403|NCT00460434|Secondary|Medical Outcomes Study 36-Item Short Form Health Survey|This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 Months post-surgery|Women who completed the Medical Outcomes Study 36-Item Short Form Health Survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
1256404|NCT00460434|Primary|Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery|Defined as a positive cough stress test or report of bothersome incontinence symptoms.|12 months post-surgery||||Participants|||Count of Participants
1256437|NCT00460239|Primary|Physiologic Effects as Assessed by Blood Pressure||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||mmHg||Standard Deviation|Mean
1256407|NCT00460421|Secondary|Long-Term Follow-Up: Progression Free Survival|Progression free survival (PFS) was defined as the number of days between the date of first investigational product administration and the date when physical or radiological evidence of disease progression is determined or death (regardless of cause)|Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||months||Full Range|Median
1256408|NCT00460421|Secondary|Long-Term Follow-Up: Incidence of Secondary Malignancies||Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
1256409|NCT00460421|Secondary|Pharmacokinetics of Palifermin, AUCtau After the 3rd IV Bolus Injection for Multiple Dose Levels|"The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)~Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose."|Day -8|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||ng*hr/mL||Full Range|Median
1256410|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Area Under the Concentration Time Curve From Zero to the End of the Dosing Interval (AUCtau) After the 1st IV Bolus Injection for Multiple Dose Levels|"The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)~Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose."|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||ng*hr/mL||Full Range|Median
1256411|NCT00460421|Secondary|Pharmacokinetics of Palifermin, t½,z After the 3rd IV Bolus Injection for Multiple Dose Levels|The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.|Day -8|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||hour||Full Range|Median
1256412|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Terminal Half-life (t½,z) After the 1st IV Bolus Injection for Multiple Dose Levels|The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||hour||Full Range|Median
1256413|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Volume of Distribution at Steady State (Vss) After the 1st IV Bolus Injection for Multiple Dose Levels||Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||mL/kg||Full Range|Median
1256414|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Clearence (CL) After the 1st Intravenous (IV) Bolus Injection for Multiple Dose Levels|Clearence was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity where the dose was given in amount palifermin actually administered.|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||mL/hr/kg||Full Range|Median
1256415|NCT00460421|Secondary|Incidence of Laboratory Abnormalities|The percentage of participants with a laboratory value outside the normal ranges during the study.|Approximately 1 1/2 months duration (Through Day +30/End of Treatment)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
1256416|NCT00460421|Secondary|Incidence of Severe Adverse Events (AEs)|The percentage of participants with a severe AE during the study was assessed.|Approximately 1 1/2 months duration (Through Day +30/End of Treatment)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
1256417|NCT00460421|Secondary|Incidence of Serum Palifermin Antibody Formation|The percentage of participants developing palifermin antibodies during the study was assessed.|Approximately 4 month duration (Through Day + 100 (+/- 40 days))|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
1256418|NCT00460421|Primary|Incidence of Dose Limiting Toxicities (DLTs)|"A DLT is appearance of side effects during treatment severe enough to prevent further increase in dosage or strength of treatment agent, or to prevent continuation of treatment at any dosage level.~A DLT was defined as: Grade 3 or 4 AE [based on Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) v3.0] considered by the investigator to be related to palifermin with the exceptions: Grade 3 erythema, pruritus or rash that resolves within 7 days of the last dose of palifermin.~The percentage of particiapnts with a DLT during the study was assessed."|Approximately 1 month duration (Day -10 through Day +16)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
1256419|NCT00460408|Secondary|Number of Participants With Serious Hypersensitivity Reactions|Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms.|Baseline up to 2 years|Safety Population|||participants|||Number
1256468|NCT00459810|Secondary|Time to Disease Progression|Time from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression|At time of progression by PSA or RECIST criteria||||Days||95% Confidence Interval|Median
1256420|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants ≥ 75 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
1256421|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants 65 to 74 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
1256422|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants 51 to 64 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
1256423|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants ≤50 years old|||percent per injection|Participants||Number
1256424|NCT00460408|Primary|Incidence of POAEs Per Injection Reported by Gender (Females)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of female participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
1256425|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Gender (Males)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of male participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
1256426|NCT00460408|Primary|Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection|POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population: participants who received at least 1 Macugen (pegaptanib sodium) injection; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
1256427|NCT00460265|Secondary|Progression Free Survival|Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.|Every 6 weeks until disease progression or deaths, upto 56 months|ITT|||months||95% Confidence Interval|Median
1256428|NCT00460265|Secondary|Time to Response|Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.|Every 6 weeks until disease progression, upto 56 months|Included only those subjects with a confirmed complete response or partial response.|||months||Inter-Quartile Range|Median
1256429|NCT00460265|Secondary|Time to Progression|Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)|Every 6 weeks until disease progression, up to 56 months|ITT|||months||95% Confidence Interval|Median
1256430|NCT00460265|Secondary|Duration of Response|Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).|Every 6 weeks until disease progression, up to 56 months|Included only those subjects with a confirmed complete or partial response.|||months||95% Confidence Interval|Median
1256431|NCT00460265|Secondary|Overall Response Rate|An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.|Every 6 weeks until disease progression, up to 56 months|The subset of subjects in the ITT analysis set with at least one baseline uni-dimensionally measurable lesion using a modified version of the RECIST v1.0 (see protocol Appendix H)|||subjects|||Number
1256432|NCT00460265|Primary|Overall Survival|Time from randomization to death|Upto 56 months|Intention to treat (ITT)|||months||95% Confidence Interval|Median
1256433|NCT00460239|Primary|Physiologic Effects as Assessed by Pupil Diameter||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||millimeters||Standard Deviation|Mean
1256434|NCT00460239|Primary|Physiologic Effects as Assessed by Oxygen Saturation||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||percentage of saturated hemoglobin||Standard Deviation|Mean
1256435|NCT00460239|Primary|Physiologic Effects as Assessed by Body Temperature||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||Degrees Fahrenheit||Standard Deviation|Mean
1269963|NCT00360334|Secondary|Change in Apolipoprotein-B|Change in apolipoprotein-B from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||g/L||Standard Error|Least Squares Mean
1256438|NCT00460239|Primary|Psychomotor/Cognitive Performance Effects Assessed by Trails B|The Trails B task specifically measures set shifting and executive functioning within the Trail-Making Test. Part B consists of 25 circles distributed over a sheet of paper. Participants are asked to connect the circles in an ascending pattern, alternating between numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||minutes||Standard Deviation|Mean
1256439|NCT00460239|Primary|Psychomotor/Cognitive Performance Effects Assessed by Digit Symbol Substitution Test (DSST)|Digit Symbol Substitution Test (DSST) is a sub-test within the Wechsler Adult Intelligence Scale and is frequently used to assess psychomotor performance changes associated with drug effects. The higher the percent correct on this measure the better the performance.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)||||percentage of correct answers||Standard Deviation|Mean
1256440|NCT00460239|Primary|Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS)|Opioid agonist effects measured by peak change from baseline drug effect visual analog scale. Scores range from 0 (not all all) to 100 (extremely); higher scores indicate a stronger drug effect.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||units on a scale||Standard Error|Mean
1256441|NCT00460109|Secondary|Time to Subsequent Therapy|Time to subsequent therapy is defined to be the time from the end of active treatment date to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier.|Up to 5 years||||months||Full Range|Median
1256442|NCT00460109|Secondary|Duration of Response|Duration of response (DOR) is defined as the time from the date at which the patient’s objective status is first noted to be either a CR, CRu or PR to the earliest date of progression. The distribution of DOR will be estimated using Kaplan-Meier methods. Response criteria for non-Hodgkin's lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.|Up to 5 years|Overall Number of Participants Analyzed reflects only the number of participants with reported data for this outcome.|||months||95% Confidence Interval|Median
1256443|NCT00460109|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier. Progression is defined using the response criteria for non-Hodgkin’s lymphoma, as at least a 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PRs or non-responders, or appearance of any new lesion during or at the end of therapy.|Up to 5 years||||||95% Confidence Interval|Median
1256444|NCT00460109|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years||||||95% Confidence Interval|Median
1256445|NCT00460109|Primary|Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response)|A confirmed tumor response is defined to be either a CR, CRu or PR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Response criteria for non-Hodgkin’s lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.|Up to 5 years||||proportion of participants||95% Confidence Interval|Number
1256446|NCT00460031|Secondary|Ratio of Change in Immune Response From Baseline|The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the ratio of BDCA-2 to BDCA-1 cells|Week 8|All patients who completed the study|||ratio||Standard Deviation|Mean
1256447|NCT00460031|Secondary|Change in Immune Response From Baseline|The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the levels of CD4+ FoxP3+ Regulatory T cells|Week 8|All patients who completed the study|||cells/ul||Standard Deviation|Mean
1256448|NCT00460031|Secondary|Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0|Patients will be evaluated for toxicity every 2 weeks during the first cycle. Thereafter, evaluations will be done every 28 days or more frequently if clinically indicated.|Up to 30 days after discontinuation of treatment|All patients who received at least one treatment in the study|||participants|||Number
1256449|NCT00460031|Secondary|Time to Progression|Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.|One year (12 months) after start of treatment|Patients with disease progression|||Months||95% Confidence Interval|Median
1277903|NCT00290615|Secondary|Safety and Tolerability|Number of participants with adverse events|After all participants went off study drug regimine.||||participants with adverse event|||Number
1256450|NCT00460031|Primary|Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease|Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.|28 days|All patients who completed the study|||participants|||Number
1256451|NCT00459979|Secondary|Median Size Reduction Among Tumors With Some Shrinkage|The median size reduction in the largest diameter of the primary RCC tumor among the tumors with at least some shrinkage in diameter|1 year from start of treatment||||cm|Participants|Full Range|Median
1256452|NCT00459979|Secondary|Number of Tumors With 30% Reduction in Size|Number of tumors with at least 30% reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol- after at least one cycle of Sunitinib|||tumors|Participants||Number
1256453|NCT00459979|Secondary|Number of Tumors Which Decreased in Size|Number of tumors with at least some reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol - after at lease one cycle of Sunitinib|||tumors|Participants||Number
1256454|NCT00459979|Secondary|Percent Decrease of Diameter of Primary Tumors|Median percent decrease in size in all primary renal cell carcinoma tumors. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol - analysis after at least one cycle of Sunitinib|||percentage of tumors diameter decrease|Participants|Full Range|Median
1256455|NCT00459979|Secondary|Progression Free Survival|Progression free survival is defined as the amount of time (in months) between the start of treatment and documented RECIST defined progression. RECIST progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition to an absolute increase of at least 5mm.|1 year from start of treatment||||months||Full Range|Median
1256456|NCT00459979|Secondary|The Number of Patients With Any Type of Complication or Adverse Event|The safety of sunitinib will be assessed by recording the number of patients with any type of complication or adverse event within 1 year of the start of therapy.|1 year from start of treatment||||participants|||Number
1256457|NCT00459979|Primary|Response to Sunitinib Therapy|Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason|1 year from start of treatment|per protocol - analysis after at least one cycle of Sunitinib|||participants|||Number
1256458|NCT00459953|Primary|Point Prevalence Abstinence|Point prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)|6 months||||participants|||Number
1256459|NCT00459875|Primary|Overall Objective Response Rate as Measured by RECIST||2 years||||participants|||Number
1256460|NCT00459862|Secondary|Overall Response Rate|"To evaluate the confirmed response rate of pazopanib in patients with MPM based on the RECIST criteria for MPM. Responses are confirmed by repeat assessments that are be performed no less than 4 weeks after the criteria for response are first met.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|Participants will be evaluated every cycle during treatment, up to 2 years|All 34 participants were evaluable for this endpoint.|||percentage of patients||95% Confidence Interval|Number
1256461|NCT00459862|Secondary|Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.|"Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline LD."|From study enrollment to the first date of disease progression|All 34 participants were evaluable for this endpoint.|||participants|||Number
1256462|NCT00459862|Secondary|Determine the Clinical Toxicities of This Drug in This Participant Population.|The number of participants with a reported Grade 3, Grade 4, and Grade 5 toxicity, regardless of attribution, will be tabulated.|Participants will be evaluated every cycle during treatment|All 34 participants were evaluable for adverse events.|||participants|||Number
1256463|NCT00459862|Secondary|Progression-free Survival Assessed by RECIST||From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years|All 34 participants were analyzed for this endpoint.|||months||95% Confidence Interval|Median
1256464|NCT00459862|Secondary|Overall Survival||From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years|All 34 participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
1256465|NCT00459862|Primary|Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)|The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.|6 months|All 34 participants were analyzed for this endpoint.|||percentage of participants|||Number
1256466|NCT00459810|Secondary|Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response|These correlative analyses were not completed. As there were no PSA responses, it was not possible to correlate serum estradiol, serum cathepsin B, or bone turnover markers with PSA response.|Measured after 4 cycles of combination therapy|||||||
1256467|NCT00459810|Secondary|Time to Death|Defined as time from Day 1 of study regimen to Date of death from any cause.|Measured at Date of Death from any cause||||Months||95% Confidence Interval|Median
1278747|NCT00284739|Primary|Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage||30 days||||participants|||Number
1256474|NCT00459706|Secondary|Participant Satisfaction at Endpoint Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean participant satisfaction was determined for each cluster of participants. Satisfaction was scored on a 10-point scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
1256475|NCT00459706|Secondary|Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 3 DMARDs was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 3 DMARDs who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants receiving only 3 DMARDs who reported themselves as very satisfied, satisfied , or not satisfied for the specified treatment arm.|||percentage of participants|||Number
1256476|NCT00459706|Secondary|Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 2 DMARDs was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 2 DMARDs, who reported themselves as very satisfied, satisfied, or not satisfied. n=number of participants receiving only 2 DMARDs who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm.|||percentage of participants|||Number
1256477|NCT00459706|Secondary|Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 1 DMARD was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 1 DMARD who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.|||percentage of participants|||Number
1256478|NCT00459706|Secondary|HAQ-DI Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAQ-DI Score, assessing the extent of functional ability, was determined for each cluster of participants. Disability score ranged from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
1256479|NCT00459706|Secondary|Physician's Global Assessment of RA Activity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean Physician's Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||millimeters on the VAS||Standard Deviation|Mean
1256480|NCT00459706|Secondary|Participant's Global Assessment of RA Activity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participants' mean Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||millimeters on the VAS||Standard Deviation|Mean
1256497|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: Side Effects from Using the Device - Q23: Do You Experience Pain During or Immediately After the Injection? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256481|NCT00459706|Secondary|DAS28 Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean DAS28 Score was determined for each cluster of participants. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1, or high when score >5.1, remission when score <2.6.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
1256482|NCT00459706|Secondary|RA Duration Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean RA Duration was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.|||years||Standard Deviation|Mean
1256483|NCT00459706|Secondary|Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The percentage of participants with prior self-injection experience was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||percentage of participants|||Number
1256484|NCT00459706|Secondary|Percentage of Participants With Prior Injection Experience Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants with prior injection experience was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||percentage of participants|||Number
1256485|NCT00459706|Secondary|PAM Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean PAM Score was determined for each cluster of participants. Calibrated PAM scale score ranged from 0 to 100.Higher scores indicated more confidence in managing participants' condition and lifestyle.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
1256486|NCT00459706|Secondary|HAD Depression Subscale Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Depression Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
1256487|NCT00459706|Secondary|HAD Anxiety Subscale Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Anxiety Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
1256498|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q22: How Much Does the Device Look Like Something You Would Feel Comfortable to Use? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256739|NCT00457418|Primary|Maximum Serum Concentration (Cmax) of PEG-Intron at 12 Weeks|Cmax was defined as observed maximum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)|||pg/mL||Standard Deviation|Mean
1256488|NCT00459706|Secondary|Percentage of Participants at University Level Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at the university level was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.|||percentage of participants|||Number
1256489|NCT00459706|Secondary|Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at high school/baccalaureate level was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants at all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.|||percentage of participants|||Number
1256490|NCT00459706|Secondary|Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants with only reading/writing capacity was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.|||percentage of participants|||Number
1256491|NCT00459706|Secondary|Percentage of Female Participants Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants who were female was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants (male+female) across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants (male+female) who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and gender.|||percentage of female participants|||Number
1256492|NCT00459706|Secondary|Percentage of Male Participants Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants who were male was determined for each cluster of participants.|Day 84|mITT. n=number of participants (male plus female) who reported themselves as being very satisfied, satisfied, or not for the specified treatment arm.|||percentage of male participants|||Number
1256493|NCT00459706|Secondary|Age Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean age was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 age clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm.|||years||Standard Deviation|Mean
1256494|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q26: If Your Doctor Advised You to, How Likely Would You to Be Continue Injecting Regularly With this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very likely.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256495|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q25: Would You Recommend this Device to Someone Else Who Needed to Self Inject? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=yes definitely.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256496|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q24: To What Extent Would You Consider Alternative Devices If You Were to Continue on Etanercept? Participants specified their responses on a 5-point Likert scale: 0=very little to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1283396|NCT00227370|Secondary|Non-CMV Infection|non cmv opportunistic infections|over the course of 300 days after randomization|intention to treat|||participants|||Number
1256499|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q21: How Much Do You Like the Feel of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256500|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q20: How Much Do You Like the Look of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256501|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q19: Overall, Are You Emotionally Distressed or Anxious about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256502|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q18: Do You Dislike Injecting Yourself with this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256503|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q17: Overall, How Nervous Do You Feel about Inserting the Needle into Your Skin? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256504|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q16: Overall, How Nervous Do You Feel about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256505|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q15: How Confident Are You That You Injected Yourself Successfully? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256506|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q14: Are You Confident That You Have Good Control over the Injection Process? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256507|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q13: How Confident Are You That You Can Inject Yourself Properly with the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256508|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q12: How Confident Are You That You Inject the Right Amount of Medicine Every Time? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256509|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q11: Overall, How Confident Are You in Your Management of Your Weekly Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256510|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q10: How Much Do You Think Injecting Etanercept Will Interfere with Travelling on Holiday/ Business/Visiting? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256511|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q9: Do You Think Injecting Etanercept Will Interfere with Your Usual Daily Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256537|NCT00459706|Secondary|Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Results are reported by age categories: <=46 years, >46-55 years, >55-65 years, >65 years.|Day 84|mITT; last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1256512|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q8: How Much Do You Think Injecting Etanercept Will Interfere with Your Ability to Enjoy Social or Leisure Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256513|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q7: How Long Does It Take to Perform the Injection, Including any Preparation and Disposal? Participants specified their responses on a 5-point Likert scale: 0=<5 minutes to 4=>30 minutes.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256514|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q6: Did You Feel any Hand Discomfort Whilst Using the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256515|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q5: How Easy Is It to Hold the Device Whilst Injecting? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256516|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q4: How Easy Is It to Know When the Injection Is Completed? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256517|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q3: How Easy Is It to Dispose Of the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256518|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q2: How Easy Was It to Learn to Use the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256519|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q1: Overall, How Easy Was It to Perform an Injection with this Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256520|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?|"Score indicated satisfaction in response to the question How satisfied are you with all the treatments you are currently receiving for your rheumatoid arthritis? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1256521|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?|"Score indicated satisfaction in response to the question How satisfied are you with your health? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1256522|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?|"Score indicated satisfaction in response to the question Thinking about your own life and personal circumstances, how satisfied are you with your life as a whole? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1256523|NCT00459706|Secondary|Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score|The SF-STAI consisted of 6 questions, each scored from 1 to 4. Total score ranged from 6=less anxiety to 24=more anxiety. Higher score indicated that the participant was more anxious.|Day 84|mITT. N=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1256524|NCT00459706|Secondary|Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior injection experience. Higher scores indicated greater satisfaction with the delivery mechanism.|Day 84|mITT; LOCF. n=evaluable participants in that category.|||units on a scale||Standard Deviation|Mean
1256525|NCT00459706|Secondary|Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants were categorized into those who received only 1 DMARD, only 2 DMARDs, only 3 DMARDs, and at least 3 DMARDs.|Day 84|mITT; LOCF. N=total evaluable participants. n=total evaluable participants for that category.|||units on a scale||Standard Deviation|Mean
1283397|NCT00227370|Secondary|Biopsy Proven Acute Lung Rejection||over the course of 300 days of randomization|intention to treat|||participants|||Number
1256526|NCT00459706|Secondary|Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The 20-item HAQ-DI assessed the extent of participants' functional ability. Calculation yielded a single disability score from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health. Results are reported by categories of HAQ-DI scores observed: <=0.9, >0.9-1.4, >1.4-1.9, >1.9.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
1256527|NCT00459706|Secondary|Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Physicians' global assessment of disease activity was measured on a VAS ranging from 0 (inactive) to 100 mm (extremely active). Results are reported by VAS scores observed for physician's global assessment of RA activity: <=47 mm, >47-61 mm, >61-72 mm, >72 mm.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
1256528|NCT00459706|Secondary|Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants' global assessment of disease activity was measured on a visual analog scale (VAS) ranging from 0 (inactive) to 100 millimeter (mm) (extremely active). Results are reported by VAS scores observed for the participant's global assessment of RA activity: <=50 mm, >50-67 mm, >67-79 mm, >79 mm.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
1256529|NCT00459706|Secondary|Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1, or high when score >5.1, remission when score <2.6. Results are reported by categories of DAS28 score: <=4.7, >4.7-5.4, >5.4-6.2, >6.2.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
1256530|NCT00459706|Secondary|Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Results are reported by duration of RA: <=3 years, >3-6 years, >6-13 years, >13 years.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
1256531|NCT00459706|Secondary|Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior self-injection experience. Higher scores indicated greater satisfaction in the delivery mechanism.|Day 84|mITT; LOCF. N=total evaluable participants. n=evaluable participants for that category.|||units on a scale||Standard Deviation|Mean
1256532|NCT00459706|Secondary|Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Results reported by PAM score: <=49.9, >49.9-56.4, >56.4-66, >66.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
1256533|NCT00459706|Secondary|Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, even-numbered questions related to depression. Responses scored on a 4-point scale; each question was graded in a different way. Depression subscale scores ranged from 0 to 21. Lower HAD Depression subscale scores indicated better health. Categories are depression subscale scores.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
1256534|NCT00459706|Secondary|Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, odd-numbered questions related to anxiety. Responses scored on a 4-point scale; each question was graded in a different way. Anxiety subscale scores ranged from 0 to 21. Lower HAD Anxiety subscale scores indicated better health. Categories are anxiety subscale scores.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
1256535|NCT00459706|Secondary|Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Participants were categorized into those having only reading/writing capacity, those at the high-school/baccalaureate level, and those at the university level.|Day 84|mITT; LOCF. N=total participants with evaluable data. n=participants with evaluable data for that category.|||units on a scale||Standard Deviation|Mean
1256536|NCT00459706|Secondary|Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism.|Day 84|mITT; LOCF. N=total evaluable participants. n=participants evaluable in that category.|||units on a scale||Standard Deviation|Mean
1256538|NCT00459706|Secondary|Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept|"Percentage of participants answering Yes to the question Are you satisfied with your injection device?"|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
1256540|NCT00459706|Primary|Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population|"Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism."|Day 84|Per-protocol (PP): mITT participants who completed the study with no major protocol violation. N=participants with evaluable data.|||units on a scale||Standard Deviation|Mean
1256541|NCT00459706|Primary|Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population|"Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism."|Day 84|Modified Intent-to-Treat (mITT): All randomized participants who received at least 1 injection of test article and had at least 1 available evaluation after the first administration of test article. Number of participants analyzed (N) = participants with evaluable data.|||units on a scale||Standard Deviation|Mean
1256542|NCT00459667|Secondary|Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values|Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.|309 days|For the NAb analyses data were provided for 572 patients at Baseline, 238 at Week 26 and 1261 at EOS. The patients missing to the total number of 1411 patients had no data at the respective visits (table shows number of patients with positive titer in the extension treatment cohorts; the analyses provide frequencies of positive titers).|||Percentage of participants|||Number
1256543|NCT00459667|Primary|Hematological Abnormalities|"The variable Hematological abnormalities will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of hematological abnormalities were provided.|||Percentage of participants|||Number
1256544|NCT00459667|Primary|Liver Enzyme Elevations|"The variable Liver enzyme elevations will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of liver enzyme elevations were provided.|||Percentage of participants|||Number
1256545|NCT00459667|Primary|Injection-site Reactions|"The variable Injection-site reactions will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Injection-site reactions with 95% confidence intervals were provided.|||Percentage of participants|||Number
1256546|NCT00459667|Primary|Flu-like-syndrome|"The variable Flu-like-syndrome will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Flu-Like-Syndrome with 95% confidence intervals were provided.|||Percentage of participants|||Number
1256547|NCT00459537|Primary|Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.|Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|Week 52|The Per-protocol population (PP) consisted of ITT patients who completed the study without protocol deviations that led to exclusion according to criteria defined before database lock The per-protocol population was used to provide confirmation of efficacy findings from the ITT population. Last Observation Carried Forward (LOCF).|||Percentage of participants|||Number
1256548|NCT00459537|Secondary|Safety and Tolerability Assessed by the Number of Participants With Adverse Events|Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE or SAE and death. Additional details can be found in the Adverse Event Section.|Week 52|The Safety population consisted of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Number
1256549|NCT00459537|Secondary|Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks|Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes|Week 52|Intent-to-treat population, Last Observation Carried Forward (LOCF)|||Percentage of participants|||Number
1256550|NCT00459537|Secondary|Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.|Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.|Week 52|Intent-to-treat population, Last Observation Carried Forward (LOCF)|||Percentage of participants|||Number
1256551|NCT00459537|Primary|Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks|Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|Week 52|The Intent-to-treat population (ITT) population consisted of all patients who were randomized and dispensed study drug. Last Observation Carried Forward (LOCF)|||Percentage of participants|||Number
1256552|NCT00459381|Secondary|Time to Progression or Progression Free Survival|"PFS for patients who died on treatment or within 30 days of the end of treatment w/out progression date, was date of death. All other pts without documented progression were censored at the date of last follow-up prior to start new treatment.~All 35 patients were included in an intent to treat analysis for PFS and OS. 3 pts censored for PFS, all less than 2 wks after study registration."|1 year||||weeks||95% Confidence Interval|Median
1256553|NCT00459381|Secondary|Overall Survival|calculated from study registration until date of death or patient censored at the last date known alive|From date of registration to date of death due to any cause, assessed up to 2 years|All 35 patients were included in an intent to treat analysis for PFS and OS.|||weeks||95% Confidence Interval|Median
1257840|NCT00448279|Primary|Progression-Free Survival - Time to Event|The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.|BL and every 8 weeks thereafter|ITT population|||months||95% Confidence Interval|Median
1256554|NCT00459381|Secondary|Best Radiographic Response|"Using the Macdonald criteria, the best MRI image response while the patient was on active treatment.~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|3 years||||percentage of participants|||Number
1256555|NCT00459381|Secondary|Overall Radiographic Response (ORR) Rate|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|2 years|34 pts had follow-up scans and wee evaluable for objective radiographic response (ORR)|||percent||95% Confidence Interval|Number
1256556|NCT00459381|Secondary|Most Common Toxicities Experienced After at Least One Dose of Pazopanib|NCI Common Toxicity Criteria (CTCAE) version 3.0. All patients that received at least one dose of pazopanib were evaluable. All events recorded that were related to drug were calculated per patient.|Up to 2 years||||percentage of participants|||Number
1256557|NCT00459381|Primary|Number of Participants Discontinuing Treatment Due to Toxicity|Use NCI Common toxicity Criteria Adverse Event Version 3.0 to grade toxicities. Any patient who received at least one dose of pazopanib was evaluable for toxicity. Calculated the number of participants who had an event that was related to pazopanib that caused the patient to stop treatment due to this event.|2 years||||Participants|||Count of Participants
1256558|NCT00459381|Primary|6 Months Progression-free Survival|Calculated from study registration till 6month time point. Progression defined by Macdonald criteria Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration|6 months||||percent||95% Confidence Interval|Number
1256559|NCT00459368|Secondary|Patient Medical Care Costs||1 year|||||||
1256560|NCT00459368|Secondary|Patient-physician Communication (Patient Reported Measure)||survey following intervention period|||||||
1256561|NCT00459368|Secondary|Readiness to Improve ICS Adherence (Transtheoretical Model)||survey following intervention period|||||||
1256562|NCT00459368|Secondary|Patient Self-efficacy to ICS Treatment||survey following intervention period|||||||
1256563|NCT00459368|Secondary|Oral Steroid Use||1 year|||||||
1256564|NCT00459368|Secondary|Asthma-related Hospitalizations||1 year|||||||
1256565|NCT00459368|Secondary|Asthma-related Emergency Room Visits||1 year|||||||
1256566|NCT00459368|Primary|Patient Adherence to Inhaled Corticosteroids (ICS)|Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.|1 year||||Percent of ICS medication taken||Standard Deviation|Mean
1256567|NCT00459355|Primary|Caregiver Self-efficacy|Caregiver self-efficacy was measured by the Revised Checklist for Caregiving Self-Efficacy; the scale consists of 17 items which are rated from 0 - 100% confidence. The total score is summed from these percentages and ranges from 0 - 1700 where higher scores indicate a higher level of confidence.|3 months after baseline||||units on a scale||Standard Deviation|Mean
1256568|NCT00459355|Secondary|Care Recipient Risky Behaviors and Accidents|The Risky Behavior Checklist listed common risky behaviors and accidents exhibited by care recipients with dementia based on previous research. Potential scores ranged from 0 - undetermined. The maximum score is undetermined because the measure represents the caregiver count of the number of times an incident occurred. In this study, sum scores ranged from 0 - 180.|3 months after baseline||||number of risky behaviors and accidents||Standard Deviation|Mean
1256569|NCT00459355|Primary|Caregiver Strain|Caregiver Strain was measured by the MBRC Caregiver Strain Index; scores ranged from 0 - 15 with higher scores indicating more strain.|3 months after baseline||||units on a scale||Standard Deviation|Mean
1256570|NCT00459342|Secondary|Time to Progression|Time in months from baseline assessment to disease progression or death for any reason, up to 5 years.|Up to 5 years|||||||
1256571|NCT00459342|Secondary|Overall Survival|Number of participants still living, measured from start of treatment to death from any cause, assessed up to 5 years using Kaplan-Meier.|Time from start of treatment to death from any cause, assessed up to 5 years|||||||
1256572|NCT00459342|Primary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death.|Time from start of treatment to time of progression or death, assessed at 2 months|Four participants were not evaluable for response.|||months||95% Confidence Interval|Median
1256586|NCT00459316|Primary|Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72|Protective levels of antibody are titers ≥1:128.|Week 72|"Participants with antibody data at Week 72. The number of Participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are:~serogroup A are 82, 108, 18, 44 serogroup C are 78, 110, 16, 44 serogroup W-135 are 80, 110, 17, 44 serogroup Y are 82, 110, 18, 44"|||participants|||Number
1256685|NCT00458211|Primary|Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia|Minimum score 32 (best) maximum 210 (worst)|Baseline to 8 weeks|The four Rochester subjects were dropped as Rochester could not continue the study.19 Bronx and 17 Buffalo subjects were analyzed separately because they were so different(see baseline characteristics)|||score on scale||Standard Deviation|Mean
1256573|NCT00459342|Primary|Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))|Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.|12 weeks|Of the 34 eligible study participants enrolled, four participants were not evaluable for response.|||participants|||Number
1256574|NCT00459316|Primary|Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24|Immunogenicity was assessed by the number of participants with protective levels of antibody (titers greater than or equal to 1:128)|At Step 3 Weeks 4 and 24 post-booster vaccine|"Participants with data for Step 3 weeks 4 and 24. The numbers for Group 1 (1-dose), Group 1 (2-dose), and Group 3 respectively are:~Week 4: 73, 71, 37 Week 24: 73, 70, 33"|||participants|||Number
1256575|NCT00459316|Secondary|Safety, as Assessed by Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Step 3 Dose of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of vaccination at Step 3 entry through 6 weeks post-vaccination|All participants who were vaccinated at Step 3 entry|||participants|||Number
1256576|NCT00459316|Secondary|Immunologic Memory or Primary Response for Serogroup C by Treatment Arm|"Immunologic Memory defined as:~Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or~Seroprotection on day 0 or change from titer <1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7.~Primary Response defined as:~A four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; or~A change from titer <1:128 on day 0 to titer ≥1:128on day 28, but not between day 0 and day 7."|At Week 4 post-booster vaccination|Group 1 participants who entered Step 3|||participants|||Number
1256577|NCT00459316|Secondary|Immunologic Memory for Serogroup C by Treatment Arm (1 vs. 2 Doses)|"Evidence of immunologic memory according to each of the following definitions:~Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or~Seroprotection on day 0 or change from titer <1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7."|At Week 1 post-booster vaccination|Participants in Group 1 who entered Step 3|||participants|||Number
1256578|NCT00459316|Secondary|Number of Participants With Protective Antibody Titers for Serogroup C at Step 3 Entry|Number of participants with protective antibody titers (rSBA>=1:128) for serogroup C by treatment arm (1 vs. 2 doses) of Group 1 (entry CD4% >= 15) at Step 3 entry|At 3.5 years|Group 1 and 3 participants at entry to Step 3|||participants|||Number
1256579|NCT00459316|Secondary|Immunogenic Response to Serogroup C in Group 2|Immunogenic response as assessed by number of participants with protective antibody titers (>= 1:128) to serogroup C in Group 2 (entry CD4%<15)|At Weeks 4, 28, and 72|Group 2 participants with response data for weeks 4, 28 and 72|||participants|||Number
1256580|NCT00459316|Primary|Number of Participants With Primary Response (in Step 3)|Primary response was defined for each serogroup as a four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; OR a change from seronegative on day 0 to seropositive on day 28, but not between day 0 and day 7. Note: a primary response can only occur in the absence of any memory response.|Step 3 entry and Week 4 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.|||participants|||Number
1256581|NCT00459316|Primary|Number of Participants With Seropositive Memory Response (in Step 3)|Seropositive memory response was defined for each serogroup by having protective antibody levels (titer >= 1:128) on Day 0 or change from seronegative to seropositive between booster dose (Day 0) and Day 7.|Step 3 entry and Week 1 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.|||participants|||Number
1256582|NCT00459316|Primary|Number of Participants With 4-fold Memory Response in Step 3|Defined for each serogroup as a four-fold rise in antibody titers between booster dose (week 0) and week 1.|Step 3 entry and Week 1 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.|||participants|||Number
1256583|NCT00459316|Primary|Number of Participants With Immunogenicity at Step 3 Entry|Immunogenicity was assessed for each serogroup by the number of participants with protective antibody levels (titers greater than or equal to 1:128)|At 3.5 years (Step 3 entry)|All participants who had antibody data for Step 3 Week 0|||participants|||Number
1256584|NCT00459316|Primary|Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Dose 2 of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of Dose 2 at week 24 to 6 weeks post-vaccination|All participants who entered Step 2|||participants|||Number
1256585|NCT00459316|Primary|Number of Participants With Grade 3 or Higher Adverse Events Within 42 Days Following Dose 1 of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of Dose 1 at week 0 to 42 days post-vaccination|All participants who received Dose 1.|||participants|||Number
1257857|NCT00448175|Secondary|OAB Quality of Life at 12 Weeks||12 weeks|||||||
1256587|NCT00459316|Primary|Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline)|Serum bactericidal antibody titers were measured at study entry and Week 4 for each of the four serogroups in the MCV-4 vaccine. Response (seroconversion) was defined as a 4-fold or greater increase from entry at Week 4.|At Study entry, Week 4|"This outcome only includes participants who had antibody data from both entry and Week 4.The number of participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are:~serogroup A are 93, 129, 20, 49 serogroup C are 90, 130, 18, 49 serogroup W-135 are 91, 131, 19, 49 serogroup Y are 93, 131, 20, 49"|||participants|||Number
1256588|NCT00459316|Primary|Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4.|Serum bactericidal antibody titers were measured at study entry and Week 28 for each of the four serogroups in the MCV-4 vaccine. Response was defined as a 4-fold or greater increase from entry at Week 28.|Study entry and Week 28|"This outcome only includes participants who received 2 doses and had antibody data from both entry and Week 28.The number of participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 are respectively:~serogroup A: 49, 63, 20, 49 serogroup C: 47, 65, 18, 49 serogroup W-135: 47, 66, 19, 49 serogroup Y: 49, 66, 19, 49"|||participants|||Number
1256589|NCT00459303|Primary|Best Corrected Contrast Sensitivity in Photopic Condition|"Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the EYEVIEW™ Functional Analysis Software into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements.~( physiological range of contrast sensitivity: 1.5 cpd : 25~82.5 ; 3 cpd: 30~150 ; 6 cpd: 65 ~ 200 ; 12 cpd: 20 ~130 ; 18 cpd: 6.5 ~ 65 )"|average data of post-operative 3rd week, 6th week, 12th week measurements||||units on a scale||Standard Deviation|Mean
1256590|NCT00459303|Secondary|Total Ocular High-order Aberrations|A Hartmann-Shack aberrometer (Zywave, Bausch & Lomb Inc., Rochester, New York ) was used for measurement of HOAs of the whole eye. The measurements were done under maximal mydriasis with Mydrin-P (phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen). The wavefront errors were described using the RMS of Zernike polynomials for total HOA at pupil diameters of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at the pupil diameter of 6 mm.|average data of post-op 3rd, 6th, 12th week measurements||||μm||Standard Deviation|Mean
1256591|NCT00459303|Secondary|Corneal High-order Aberrations|Corneal topography was performed with a TMS-4 corneal tomographer (Tomey, Japan). We used the 31-rings placido-based system that covers 10.9 mm of corneal diameter which is sufficient for the study of aberrations up to the fifth order for 6 mm diameter. Corneal HOAs were described with Zernike polynomials of 3rd- to 5th-order root-mean-square (RMS) of central 6mm diameter using VOLPro 6.89 software (Fa. Sarver and Associates, Carbondale. Ill, USA).|pre-op & averate data of post-op 3rd, 6th, 12th week measurements||||μm||Standard Deviation|Mean
1256592|NCT00459303|Primary|Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition|Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.|average data of post-op 3rd, 6th, 12th week measurements|"we obtained data and calculated the probable sample size needed from the following reference papers:~Ophthalmologe 2005 Jan;102(1):51-7.~Acta Ophthalmol Scand 2004;82(6):718-22."|||log MAR||Standard Deviation|Mean
1256593|NCT00459290|Secondary|Progression-free Survival by Age (y)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||months||95% Confidence Interval|Median
1256594|NCT00459290|Secondary|Progression-free Survival by Performance Status||Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||months||95% Confidence Interval|Median
1256595|NCT00459290|Secondary|Progression-free Survival by Platinum Sensitivity|Platinum Senstive defined as treatment free interval >6 months on most recent platinum|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants with treatment free interval available|||months||95% Confidence Interval|Median
1256596|NCT00459290|Secondary|Overall Survival||Five years|Eligible and treated participants|||months||95% Confidence Interval|Median
1256606|NCT00459121|Secondary|Assess the Clinical Response Rate of the Proposed Pre-operative Regimen|Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression. If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy|End of three cycles of treatment|||||||
1257858|NCT00448175|Secondary|Volume Voided at 12 Weeks||12 weeks|||||||
1256597|NCT00459290|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||months||95% Confidence Interval|Median
1256598|NCT00459290|Primary|Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Every cycle, during treatment (average of 3 months).|Eligible and treated patients|||Participants|||Count of Participants
1256599|NCT00459290|Primary|Proportion of Patients With Objective Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||percentage of participants||95% Confidence Interval|Number
1256600|NCT00459290|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||percentage of participants||95% Confidence Interval|Number
1256601|NCT00459186|Secondary|Response Based on PET Scan|Patients were scanned using Positron Emission Tomography (PET) before and after receiving single agent RAD001. Patients were classified as having partial metabolic response, stable metabolic disease, or progressive metabolic disease based on changes in PET imaging from baseline to post-treatment. A positive FDG-PET for the purposes of this study consisted of a visualized area of abnormal increased FDG uptake that matched the anatomic location of an abnormality seen on bone scan or CT. Metabolic response was assessed for percent change in SUVmax according to the criteria of the European Organization for Research and Treatment of Cancer (EORTC) : partial metabolic response (PMR) ≤ -25%; stable metabolic disease (SMD) -25% + 25%; progressive metabolic disease (PMD) > 25%.|10 to 14 days after study entry|All patients receiving at least one dose of RAD001|||percentage of participants||90% Confidence Interval|Number
1256602|NCT00459186|Primary|Number of Patients Free of Dose Limiting Toxicity|"A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria:~Hematologic Toxicity:~CTCAE grade 4 neutropenia > 7 days or any Grade 3 or 4 neutropenia with fever Or CTCAE grade 3 or 4 thrombocytopenia > 7 days~Non-hematologic toxicity:~The occurrence of non-hematologic CTCAE grade 3 or 4 adverse events will be considered dose limiting, except for the following:~CTCAE grade 3 nausea or grade 3 or 4 vomiting CTCAE grade 3 or 4 vomiting will only be considered dose limiting if it occurs despite the use of standard anti-emetics.~CTCAE grade 3 or 4 fever identified with a source (i.e. infection, tumor)~CTCAE grade 3 or 4 alkaline phosphatase."|21 days|Patients who received combination treatment with RAD001 + Docetaxel|||participants|||Number
1256603|NCT00459134|Secondary|Quality of Life|Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.|12 weeks|Participants who filled out the FACT-G at any time|||units on a scale||Standard Error|Least Squares Mean
1256604|NCT00459134|Primary|Sexual Function|Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.|12 weeks|Participants who filled out the FSFI at any time|||units on a scale||Standard Error|Least Squares Mean
1256605|NCT00459121|Secondary|Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.|Evaluation of the number of patients who have no evidence of tumor in the resected tumor.|30 days post surgery|||||||
1257859|NCT00448175|Secondary|Urge Incontinence Episodes at 12 Weeks||12 weeks|||||||
1256607|NCT00459121|Secondary|Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy|Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT [AST], SGPT [ALT], sodium, laboratory tests should be done on a weekly basis for the first cycle. After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel.|Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel|||||||
1256608|NCT00459121|Secondary|Post-Operative Mortality Rate||at 30 days|||||||
1256609|NCT00459121|Primary|Complete Resection (R0) Rate||Following three cycles of pre-operative zactima and carboplatin/paclitaxel|No analysis will be completed.||||||
1256610|NCT00459108|Secondary|Safety and Tolerability|Summarize observed grade 3 and higher toxicities related to dasatanib. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were used for reporting.|Up to 4 years|One patient died due to underlying cardiac disease which may have been exacerbated by the dasatanib.|||participants|||Number
1256611|NCT00459108|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 4 years||||Months||95% Confidence Interval|Median
1256612|NCT00459108|Secondary|Median Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression or death, up to 4 years||||Months||95% Confidence Interval|Median
1256613|NCT00459108|Primary|Four Month Progression-free Survival (PFS)|Progression-free survival calculated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 months||||percentage of participants||95% Confidence Interval|Number
1256614|NCT00459108|Primary|Response Rate (Complete and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR|4 months||||percentage of responding patients|||Number
1256615|NCT00459056|Primary|Change in Reactive Hyperemic Index by Period (Carvedilol CR + Lisinopril vs. Lisinopril + HCTZ)|Reactive hyperemic index is a measure of endothelial function. This is measured by the ratio of post-occlusion blood volume flow versus the baseline blood volume flow. The outcome reported is the change in this ratio after the first intervention phase compared to after the second intervention phase.|Change from three months to seven months|All completers were included in the analysis|||Ratio||Standard Deviation|Mean
1256616|NCT00459043|Secondary|Overall Survival||3 years||||weeks||95% Confidence Interval|Median
1256617|NCT00459043|Secondary|Progression Free Survival|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sumof the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions|3 years||||weeks||95% Confidence Interval|Median
1256618|NCT00459043|Primary|Partial Response Rate in Both Groups of Patients.|Objective tumor response was evaluated radiogically using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. For target lesions: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diamter of target lesions; Overall Response (OR) = CR+PR|3 years|29 patients were analyzable|||percentage of participants||95% Confidence Interval|Number
1256619|NCT00458952|Primary|MTD of Ultratrace Iobenguane I 131|Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.|6 weeks post therapy dose|24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in this trial. Of the 24 consenting patients, 21 patients were administered Ultratrace iobenguane I 131. Three patients did not meet all the inclusion and exclusion criteria, and were not allowed into the study.|||mCi/kg|||Number
1256620|NCT00458822|Primary|Hematologic and Organ Response|patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.|2-3 months post transplant||||participants|||Number
1256621|NCT00458705|Primary|Disease Response|The response of myeloma to BDDTD will be assessed by standard electrophoretic and immunofixation tests of blood and urine for a monoclonal protein (M protein), and bone marrow aspirate and biopsy. These tests will be performed at enrollment and at the conclusion of therapy.|2 years||||participants|||Number
1256622|NCT00458536|Secondary|to Correlate Immunologic Response Following Vaccination.||5 years|||||||
1256623|NCT00458536|Secondary|To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF||5 years|||||||
1256624|NCT00458536|Primary|Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF||5 years|Adverse events potentially related to vaccination were largely restricted to injection site reactions. 12 of the 19 patients experienced vaccine site reactions.|||participants|||Number
1256625|NCT00458406|Primary|Change in Minutes of Use Per Night From Month 1 to Month 3|minutes of use per night at Month 3 minus minutes of use per night at Month 1|month 1, month 3||||minutes||Standard Deviation|Mean
1256626|NCT00458406|Primary|Minutes of Use Per Night at Month 3|The number of minutes of use per night at Month 3.|3 Months|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|||minutes||Standard Deviation|Mean
1256627|NCT00458406|Secondary|Pediatric Quality of Life (PedQL)||3 months|||||||
1256629|NCT00458406|Secondary|Change in ESS From Month 1 to Month 3|Change in the Epworth Sleepiness Scale (ESS) score from Month 1 to Month 3: (Score at Month 3 minus Score at Month 1). The ESS measures daytime sleepiness in certain situations e.g. sitting/reading, watching television, sitting inactive in public, as a passenger in a car for an hour without a break, lying down to rest in the afternoon when circumstances permit, sitting/talking with someone, sitting quietly after lunch, or in a car, while stopped for a few minutes in traffic. The scale ranges from a minimum of zero to 24, with higher scores indicating greater daytime sleepiness.|3 months||||units on a scale||Standard Deviation|Mean
1256630|NCT00458406|Secondary|Obstructive Sleep Apnea (OSA) 18 Score||3 months|||||||
1256631|NCT00458406|Secondary|Change in Apnea Hypopnea Index (AHI; Number of Apneas and Hypopneas Per Hour of Sleep) From Month 1 to Month 3|Change in Apnea Hypopnea Index from Month 1 to Month 3. AHI at Month 3 minus AHI at Month 1.|3 months|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|||Apneas and Hypopneas/hr sleep||Full Range|Median
1256632|NCT00458406|Secondary|Drop Out Rate|Number of drop-outs included subjects in which investigators were unable to obtain a final download from the device.|3 months|Power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|||participants|||Number
1256633|NCT00458406|Primary|Minutes of Use Per Night at Month 1|The number of minutes of use per night at month 1.|1 month|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|||minutes||Standard Deviation|Mean
1256634|NCT00458393|Secondary|Diagnosis of Gonorrhea During the Follow-up Period|Diagnosis of gonorrhea during the follow-up period by PCR|All of follow-up period, median of 1.2 years|All participants with at least one follow-up test for gonorrhea|||Participants|||Count of Participants
1256635|NCT00458393|Secondary|Incidence of HSV-2 During the Follow-up Period|Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline|Total study follow-up, a median of 1.2 years|All HSV-2 negative participants with a follow-up HSV-2 test.|||Participants|||Count of Participants
1256636|NCT00458393|Secondary|Incidence of Confirmed Syphilis During Follow-Up|Number of participants who have at least 1 confirmed syphilis infection during the study|All Follow-Up median of 1.2 years of follow-up|Participants without active syphilis at baseline with a follow-up syphilis test.|||Participants|||Count of Participants
1256637|NCT00458393|Secondary|Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.|Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status.|At 24 weeks|Participants interviewed about sexual practices at week 24|||Participants|||Count of Participants
1256638|NCT00458393|Secondary|Total Number of Sexual Partners|Self-reported total number of sexual partners in the previous 12 weeks.|24 weeks|Participants interviewed about sexual practices at week 24|||Count||Inter-Quartile Range|Median
1256639|NCT00458393|Secondary|Number of Condomless Sexual Partners With HIV Positive or Unknown Status|Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex|At 24 weeks|Participants interviewed about sexual practices at week 24|||count||Inter-Quartile Range|Median
1256640|NCT00458393|Secondary|Percentage of Missed Doses by Estimate During CASI Interview|Percentage of missed doses by estimate during computer assisted structured interview|Week 24|All participants who answered the adherence question with an estimated adherence on the week 24 computer assisted structured interview|||percentage of doses taken||Standard Error|Mean
1256641|NCT00458393|Secondary|Proportion of Missed Doses by Pill Count|Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles)|At 24 weeks|Those who bottles returned at the week 24 visit.|||proportion of pills not returned||95% Confidence Interval|Mean
1256642|NCT00458393|Secondary|CD4 Count Among HIV Infected Participants|CD4 cell count for HIV infected participants during the trial|at the time infection was detected|HIV infected participants during the trial including those HIV+ at baseline|||cells per cubic mm||95% Confidence Interval|Mean
1256643|NCT00458393|Secondary|Among HIV Infected Participants Drug Resistance|Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period|at the time of HIV acquisition|There were 2 TDF/FTC seroconversions at enrollment and 48 during follow-up. There were 8 Placebo seroconversions at enrollment and 83 during follow-up.|||Participants|||Count of Participants
1256644|NCT00458393|Secondary|Viral Load Among HIV Infected Participants|HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection|At the time closest to HIV detection|All HIV infections detected during the study including prior to, during and after study treatment|||log RNA copies per ml||Standard Error|Mean
1256645|NCT00458393|Secondary|Percent Change in Total Cholesterol|Percent change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in fasting total cholesterol from baseline|Baseline and Week 24|All participants in the metabolic substudy with a week 24 fasting cholesterol|||percent change from baseline||Standard Error|Median
1256646|NCT00458393|Secondary|Percentage Change in Fasting Triglycerides|Percentage Change (Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Triglycerides from Baseline from a fasting sample.|Baseline and Week 24|All participants in the metabolic substudy with a week 24 fast triglyceride value|||percent change from baseline||Standard Error|Median
1256647|NCT00458393|Secondary|Percentage Change in Body Fat|Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Body Fat from Baseline by dual-energy x-ray absorptiometry|Baseline and Week 24|All participants in the body composition substudy who made a week 24 body scan|||percent change from baseline||Standard Error|Median
1256686|NCT00457977|Secondary|Serotype-specific Immunoglobulin G (IgG) Antibody Levels|Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)|Measured at Baseline, Months 1, 12, and 24|All participants with blood samples were analyzed.|||ug/ml||95% Confidence Interval|Geometric Mean
1256648|NCT00458393|Secondary|Percentage Change in Bone Mineral Density|% Change from baseline in bone mineral density (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry|baseline and week 24.|Participants confirmed to be HIV negative at enrollment who consented to participate in the metabolic substudy. Full details in https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25908682/|||percent change from baseline||Standard Error|Mean
1256649|NCT00458393|Secondary|Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis|"A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to >5 fold upper limit of normal at any visit, or an increase to >2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug.~More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/"|Quarterly lab tests through a median follow-up of 1.2 years|Those with chronic active hepatitis B at enrollment.|||Participants|||Count of Participants
1256650|NCT00458393|Primary|Grade 2, 3, or 4 Clinical Adverse Events|Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf|Entire follow-up, median 1.2 years|At participants with at least one follow-up visit|||Participants|||Count of Participants
1256651|NCT00458393|Primary|Grade 2, 3, or 4 Laboratory Adverse Events|Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf|Entire follow-up, median 1.2 years|At participants with at least one visit with laboratory values post-baseline|||Participants|||Count of Participants
1256652|NCT00458393|Primary|Grade 3 or Higher Phosphorous Toxicity|Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL)|The entire follow-up period, median 1.2 years|All participants with at least 1 follow-up phosphorus value|||Participants|||Count of Participants
1256653|NCT00458393|Primary|Grade 1 or Higher Creatinine Toxicity|Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf|Duration of follow-up, median 1.2 years|All randomized participants which at least 1 follow-up creatinine value|||Participants|||Count of Participants
1256654|NCT00458393|Primary|HIV Seroconversion|Confirmed HIV infection|Monthly follow-up through a median of 1.2 years|Excludes participants who were HIV+ at enrollment (2 TDF/FTC, 8 Placebo) and those with no follow-up HIV test (25 TDF/FTC and 22 Placebo).|||Participants|||Count of Participants
1256655|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale|The FAHI social well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
1256656|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale|The FAHI physical well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
1256657|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale|The FAHI functional and global well-being subscale. Each item is assessing the impact of HIV on functional and global well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
1256658|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale|The FAHI emotional well-being subscale. Each item is assessing the impact of HIV on emotional well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
1256659|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale|The FAHI cognitive function subscale. Each item is assessing the impact of HIV on cognitive function on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
1256660|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score|The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
1256661|NCT00458302|Secondary|Resistance Determinations|Number of patients with resistance mutations at any time point when a patient had a viral load > 50 copies/mL after randomization.|at each visit from baseline to week 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of their adherence to the protocol.|||number of participants|||Number
1256662|NCT00458302|Secondary|Mean Change From Baseline in CD4+ Cell Count|The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.|at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144|ITT: all randomized patients who had at least 1 dose of study medication, regardless of their adherence to the protocol|||number of cells/L (x10^6)||Standard Error|Mean
1256663|NCT00458302|Secondary|Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144|week 144|PP population: all randomised patients who took study drug, and who did not deviate from the protocol. This excludes 13 patients with major protocol deviations.|||Participants|||Number
1256664|NCT00458302|Secondary|Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]|Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). All switches included means that all data even after any changes of treatment were kept. *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 144 window.|Week 144|ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.|||participants|||Number
1256665|NCT00458302|Secondary|Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144|Week 144|PP population: all randomised subjects who took study drug, and who did not deviate from the protocol.This excludes 13 subjects with major protocol deviations.|||participants|||Number
1256666|NCT00458302|Secondary|Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]|Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 48 window|Week 48|ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.|||participants|||Number
1256667|NCT00458302|Primary|Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 48|Week 48|PP population: all randomised patients who took study drug, and who did not deviate from the protocol.This excludes 10 patients with major protocol deviations.|||participants|||Number
1256668|NCT00458237|Secondary|Clinical Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall clinical response defined as achieving stable disease (SD), partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response. SD is neither CR/PR or progressive disease (PD). PD is at least a 20% increase in sum LD, takings as reference smallest sum LD since treatment started.|Disease assessments occurred every 9 weeks (3 cycles) on treatment. Treatment continued until disease progression or unacceptable toxicity. Median duration of treatment was 2.4 months.|The analysis dataset is comprised of patients treated at the MTD/dose level 2.|||proportion of participants||90% Confidence Interval|Number
1256669|NCT00458237|Primary|Maximum Tolerated Dose (MTD)|"The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. Dose Limiting Toxicities (DLTs) were defined as follows (CTCAE v4.0):~Any grade 4 hematologic toxicity, excluding anemia.~Any grade 3 or 4 nonhematologic toxicity, except for nausea, vomiting, diarrhea, or hyperlipidemia that responds promptly (within 24 hours for nausea, vomiting, and diarrhea and within 1 week for hyperlipidemia) to appropriate treatment, and except for cardiac toxicity which will be assessed after 12 weeks of treatment.~Need to hold >1 dose of trastuzumab or > 7 doses of RAD001 within the first 3 weeks because of the presence of toxicity."|Cycle One (first 21 days of treatment)|The analysis dataset for the Phase I study is comprised of the two dose cohorts: Level 1 and 2.|||participants with DLT|||Number
1256670|NCT00458211|Secondary|Antipsychotic Medication Costs||8 weeks|||||||
1256671|NCT00458211|Secondary|Insulin Level||8 weeks|||||||
1256672|NCT00458211|Secondary|HgbA1c||8 weeks|||||||
1256673|NCT00458211|Secondary|Barnes Akathisia Scale||8 weeks|||||||
1256674|NCT00458211|Secondary|MOS-COG||8 weeks|||||||
1256675|NCT00458211|Secondary|PETiT||8 weeks|||||||
1256676|NCT00458211|Secondary|CDSS||8 weeks|||||||
1256677|NCT00458211|Secondary|BACS||8 weeks|||||||
1256678|NCT00458211|Secondary|QTc|Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous|8 weeks||||msec||Standard Deviation|Mean
1256679|NCT00458211|Secondary|Simpson-Angus Scale Measures Drug Induced Parkinsonism|Measures 10 signs, (not all of which are now considered Parkinsonism), minimum score 0 (no Parkinsonism) maximum 40.|8 weeks|see PANNS above|||score on scale||Standard Deviation|Mean
1256680|NCT00458211|Secondary|Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia|Scores 0 (none) to 4 (severe) choreo-athetoid and dystonic movements of seven parts of the body with a maximum score 28|8 weeks|17 Buffalo subjects and 19 Bronx subjects|||score on scale||Standard Deviation|Mean
1256688|NCT00457951|Primary|Incidence of Treatment Failure|"The primary outcome of the study is Treatment Failure as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital."|Time to hospital discharge and 21 days post-treatment, up to 31 days|Of the 138 subjects randomized, 132 were analyzed in the intent-to-treat population. Of the 6 excluded from the intent-to-treat population, 4 did not receive study drug and 2 lacked information for assessment.|||percentage of failures||95% Confidence Interval|Number
1256689|NCT00457821|Primary|Number of Adverse Events (Combined Part 1 and Part 2)|Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.|Baseline to Follow-up|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||events|||Number
1256690|NCT00457821|Secondary|Change From Baseline in Maximum Sweat Chloride Concentration (Combined Part 1 and Part 2)|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.|||millimoles per liter||95% Confidence Interval|Least Squares Mean
1256691|NCT00457821|Secondary|Change From Baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score (Part 2 Only)(Respiratory Domain Score)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|14 days and 28 days|Part 2 is a parallel study. Subjects were counted only once for each treatment group.|||score on a scale||Standard Deviation|Mean
1256692|NCT00457821|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second [FEV1] (Combined Part 1 and Part 2)|"Spirometry is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.~Relative change reflects the percent change from the baseline values [100% * (X-Y)/Y], where X and Y are post-baseline and baseline values, respectively."|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.|||percent predicted (%)||95% Confidence Interval|Least Squares Mean
1256693|NCT00457821|Secondary|Change From Baseline in Nasal Potential Difference (Combined Part 1 and Part 2)|The transepithelial nasal potential difference (NPD) is a direct measure of transepithelial ion transport. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol was of primary interest.|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.|||millivolts||95% Confidence Interval|Least Squares Mean
1256694|NCT00457821|Primary|Number of Subjects With Adverse Events (Combined Part 1 and Part 2)|Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.|Baseline to Follow-up|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||participants|||Number
1256695|NCT00457795|Secondary|Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4|Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1256696|NCT00457795|Secondary|Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4|Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1256697|NCT00457795|Secondary|Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4|Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.|Baseline, Week 4|Intent to Treat defined as all patients who started the study (randomized)|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1256698|NCT00457795|Primary|Intraocular Pressure (IOP) for a 24-Hour Period at Week 4|IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1256740|NCT00457418|Primary|Area Under the Curve (AUC) of PEG-Intron at 12 Weeks|AUC was defined as the actual body exposure to drug after administration of a dose of the drug.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)|||pg*hr/mL||Standard Deviation|Mean
1256699|NCT00457743|Secondary|Overall Survival Time|"Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive.~Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once."|From the first dose to death|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
1256700|NCT00457743|Secondary|Time To Failure (TTF)|Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer.|From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
1256701|NCT00457743|Primary|Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group|Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||participants|||Number
1256702|NCT00457743|Primary|Accumulation Ratio (Rac) on Cycle 1 Day 28|"Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1.~Rac was the ratio of Day 28 to Day 1."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."|||ratio||Standard Deviation|Mean
1256703|NCT00457743|Primary|SU-011248 Clearance on Cycle 1 Day 28|"SU-011248 Clearance in the subjects enrolled in Phase 1.~Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."|||L/h||Standard Deviation|Mean
1256704|NCT00457743|Secondary|Progression-Free Survival (PFS)|Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death.|From the first dose to Progressive Disease or Death|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
1256705|NCT00457743|Primary|Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28|"Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."|||hours||Full Range|Median
1256706|NCT00457743|Primary|Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1|"Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.|||hours||Full Range|Median
1256707|NCT00457743|Primary|Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28|"Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued the dose on Cycle1, therefore no data showed."|||ng•h/mL||Standard Deviation|Mean
1256708|NCT00457743|Primary|Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1|"Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.|||ng•h/mL||Standard Deviation|Mean
1256709|NCT00457743|Secondary|Time To Tumor Progression (TTP)|Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD).|From the first dose to Progressive Disease|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
1256710|NCT00457743|Secondary|Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group|Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|ITT population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||participants|||Number
1256812|NCT00456885|Secondary|Systolic Blood Pressure|Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded.|16 weeks after the beginning of each treatment||||mm of mercury||95% Confidence Interval|Mean
1256711|NCT00457743|Primary|Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28|"Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."|||ng/mL||Standard Deviation|Mean
1256712|NCT00457743|Secondary|Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group|Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||participants|||Number
1256713|NCT00457743|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires|"The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health.~Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline"|Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n= Number of subjects with analyzable data."|||index scores on a scale||Standard Deviation|Mean
1256714|NCT00457743|Secondary|Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires|"Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A).~The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated.~Change from Baseline: Score at each observation minus score at baseline"|Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n= Number of subjects with analyzable data."|||scores on a scale||Standard Deviation|Mean
1256715|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."|||ng/mL||Standard Deviation|Mean
1256716|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-012262|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."|||ng/mL||Standard Deviation|Mean
1256717|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."|||ng/mL||Standard Deviation|Mean
1256718|NCT00457743|Secondary|Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)|Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."|||pg/mL||Standard Deviation|Mean
1256719|NCT00457743|Secondary|Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."|||pg/mL||Standard Deviation|Mean
1256720|NCT00457743|Secondary|Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."|||pg/mL||Standard Deviation|Mean
1256721|NCT00457743|Primary|Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1|"Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
1256722|NCT00457743|Primary|Number of Subjects With Dose Limiting Toxicities (DLT)|Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.|Cycle 1 (Baseline to Week 6)|DLT analysis population consists of subjects who developed DLT or received 85% of the planned dose. One subject in 75-mg dose group was excluded from DLT analysis population because the subject received less than 85% of the planned dose.|||participants|||Number
1256723|NCT00457730|Secondary|Global Impression of Change|"global impression: How do you feel about the effects of the medication over the past 7 days? 7 point scale, 7 = delighted, 1= terrible"|Week 6 vs baseline||||units on a scale||Standard Deviation|Mean
1256724|NCT00457730|Secondary|Percent Change in Average Pain Score.|Percent change in Weekly mean of 24 hour Average pain Score, Week 6 vs. baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.|at week 6||||percent reduction on 0-10 analog scale||Standard Deviation|Mean
1256726|NCT00457691|Secondary|Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The change from baseline scores for EQ-VAS were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).|||Scores on a scale||95% Confidence Interval|Mean
1256727|NCT00457691|Secondary|Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire|"EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state."|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The EQ-5D health state index results were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).|||Scores on a scale||95% Confidence Interval|Mean
1256728|NCT00457691|Secondary|Change From Baseline in MDASI-GI Symptom Interference Score|Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, 11).|||scores on a scale||95% Confidence Interval|Mean
1256729|NCT00457691|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score|Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal|ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, and 11).|||Scores on a scale||95% Confidence Interval|Mean
1256730|NCT00457691|Secondary|Duration of Response (DR)|DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.|Day 28 of Cycle 1 up to 30 months|ITT Population (participants with a confirmed objective tumor response).|||Weeks||95% Confidence Interval|Median
1256731|NCT00457691|Secondary|Number of Participants With Overall Confirmed Objective Response|Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 30 months||||Participants|||Number
1256732|NCT00457691|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.|Baseline up to 30 months|ITT Population.|||Weeks||95% Confidence Interval|Median
1256733|NCT00457691|Primary|Progression-free Survival (PFS)|PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.|First dose of study treatment up to 30 months|Intent-to-treat (ITT) population included all participants who were randomized.|||Weeks||95% Confidence Interval|Median
1256734|NCT00457418|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) was defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, whether or not considered related to the use of that product.|Entire study duration (up to 5 years)||||participants|||Number
1256735|NCT00457418|Primary|Apparent Clearance(CL/F) of PEG-Intron at 12 Weeks|CL/F was defined apparent clearance - the volume of plasma in the vascular compartment cleared of drug per unit of time and per kilogram of body weight by the processes of metabolism and excretion.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|There were 15 evaluable participants (20 participants completed the full 12 weeks of treatment without any significant dose modification but for 5 participants CL/F could not be reported because t1/2 could not be accurately determined).|||L/hr/kg||Standard Deviation|Mean
1256736|NCT00457418|Primary|Observed Time to Achieve Cmax (Tmax) of PEG-Intron at 12 Weeks|Tmax was defined as time of maximum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose).|||hours||Full Range|Median
1256737|NCT00457418|Primary|Minimum Serum Concentration (Cmin) of PEG-Intron at 12 Weeks|Cmin was defined as observed minimum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|There were 19 evaluable participants (20 participants completed the full 12 weeks of treatment without any significant dose modification and there was no concentration data for 1 participant at Week 12).|||pg/mL||Standard Deviation|Mean
1256738|NCT00457418|Primary|Average Concentration Within the Dosing Interval (Cavg) of PEG-Intron at 12 Weeks|Cavg was defined as average plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)|||pg/mL||Standard Deviation|Mean
1256741|NCT00457392|Secondary|EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state."|Baseline and End of Treatment (EOT) or Withdrawal|Patients Reported Outcome (PRO) Analysis Set included participants from the FA population who had at least one EQ-5D assessment while on treatment. The 'n' signifies those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1256742|NCT00457392|Secondary|One-year Survival Probability|The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate.|Baseline until death or until 28 days after last dose for the last participant|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Percent chance of survival||95% Confidence Interval|Number
1256743|NCT00457392|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.|Baseline to disease progression or death or discontinuation from study or 28 days after last dose|DR was calculated for the subgroup of participants from the FA set, with a confirmed objective tumor response.|||Weeks||95% Confidence Interval|Median
1256744|NCT00457392|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline to disease progression or discontinuation from study or 28 days after last dose|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1256745|NCT00457392|Secondary|Progression-Free Survival (PFS)|"Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline to disease progression or death due to any cause or 28 days after last dose|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
1256746|NCT00457392|Primary|Overall Survival (OS)|Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline to death or 28 days after last dose for the last participant|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1256747|NCT00457301|Primary|EuroQol, EQ-5D.|Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute (“no problem”, “some problems” and “extreme problems”).Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable.|At baseline and end of study (6 months).|To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error, two-sided-test and 80% power. ITT was conducted for 213 recruited patients. 47 records were imputed using LOCF.|||mean EQ-5D index score||Standard Deviation|Mean
1256748|NCT00457301|Primary|Management Composite|Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite.|At baseline and end of study (6 months)|Analysis was conducted using ITT, with 47 observations carried forward.|||mean management composite||Standard Deviation|Mean
1256749|NCT00457301|Secondary|The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.|HADS is a self-complete mental health measure. The scale consists of 14 items, seven of which assess anxiety and seven which assess depression. Each item is on a four point scale and the scores are added to give a total ranging from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores indicate more severe anxiety or depression. A cut-point of 8 or 9 indicates mild burden for the two scales; 11 or 12 indicates severe . All the patients completed HADS at baseline and at the end of the study.|Baseline and end of study (6 months)|47 observation were imputed by LOCF and analyzed as ITT.|||mean anxiety and depression||Standard Deviation|Mean
1256813|NCT00456885|Secondary|Change in Waist Circumference||16 weeks from the start of each treatment period.||||centimeters||95% Confidence Interval|Mean
1256814|NCT00456885|Primary|Change in Body Mass Index||16 weeks from the start of each treatment period.||||Kg/m^2||95% Confidence Interval|Mean
1256750|NCT00457301|Primary|Communication Score|Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems.|Baseline and end of study (6 months)|Traditional analysis of covariance, ANCOVA was conducted to explore the difference between control and intervention groups at 6 months adjusting for baseline scores and transplant status. ITT was conducted and missing values were imputed using the LOCF.|||Mean number of issues discussed||Standard Deviation|Mean
1256751|NCT00457249|Other Pre-specified|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.|Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.|Day 0 up to 14 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.|||Participants|||Number
1256752|NCT00457249|Primary|Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.|Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.|Day 35 post-vaccination|Booster response was assessed in the per-protocol population.|||Percentage of Participants|||Number
1256753|NCT00457249|Primary|Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.|Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.|Day 35 post-vaccination|Seroprotection was assessed in the per-protocol population|||Percentage of Participants|||Number
1256754|NCT00457249|Primary|Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine||Day 35 post-vaccination|GMTs and their 95% Confidence Intervals were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1256755|NCT00457197|Secondary|Penn Alcohol Craving Scale (PACS)|"The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking~Score:~Minimum: 0 Maximum: 30 Lower score associated with better outcome."|12 weeks|Missing data for 1 participants in placebo group and 5 participants in the quetiapine group.|||units on a scale||Standard Error|Least Squares Mean
1256756|NCT00457197|Secondary|Young Mania Rating Scale (YMRS)|"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).~Score:~Minimum: 0 Maximum: 60 Lower score associated with better outcome"|12 weeks|Missing data for 6 participants in placebo group and 1 participant in the quetiapine group.|||units on a scale||Standard Error|Least Squares Mean
1256757|NCT00457197|Secondary|Inventory of Depressive Symptomatology-Self Report (IDS-SR)|"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.~Score:~Minimum: 0 Maximum: 84 Lower score associated with better outcome"|12 weeks|Missing data for 4 participants in placebo group and 2 participants in the quetiapine group.|||units on a scale||Standard Error|Least Squares Mean
1256758|NCT00457197|Secondary|Hamilton Rating Scale for Depression (HRSD)|"The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).~Scale:~Minimum: 0 Maximum: 50 Lower score associated with better outcome"|12 weeks|Missing data for 2 participants in placebo group and 3 participants in the quetiapine group.|||units on a scale||Standard Error|Least Squares Mean
1256759|NCT00457197|Secondary|Alanine Aminotransferase (ALT)|ALT is a liver enzyme measurement (IU/I).|12 weeks|Missing data for 17 participants in placebo group and 13 participants in the quetiapine group.|||IU/I||Standard Error|Least Squares Mean
1256760|NCT00457197|Secondary|Aspartate Aminotransferase (AST)|AST is a liver enzyme measurement (IU/I)|12 weeks|Missing data for 19 participants in placebo group and 11 participants in the quetiapine group.|||IU/I||Standard Error|Least Squares Mean
1256761|NCT00457197|Secondary|Gamma-glutamyltransferase (GGT)|GGT is a liver enzyme measurement (IU/I)|12 weeks|Missing data for 18 participants in placebo group and 11 participants in the quetiapine group.|||IU/I||Standard Error|Least Squares Mean
1256762|NCT00457197|Secondary|Percent of Heavy Drinking Days||12 weeks||||drinks||Standard Error|Least Squares Mean
1256763|NCT00457197|Primary|The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.||12 weeks||||drinks||Standard Error|Least Squares Mean
1256764|NCT00457015|Secondary|Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours|"Maintenance of significant improvement was defined as achieving and maintaining a significant improvement in overall response through 24 hours after dosing. Patient response categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse."|24 hours post-dosing|Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.|||participants|||Number
1256765|NCT00457015|Secondary|Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score|A successful response was defined as improvement in existing laryngeal symptom complex,stabilization of an existing peripheral symptom complex, or a change from baseline in the MSCS score at 4 hours of at least -1.0.|baseline, 4 hours post-dosing|Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.|||participants|||Number
1256815|NCT00456885|Primary|Change in Weight|Change in weight at the end of each treatment period.|16 weeks after the beginning of each treatment||||kilograms||Standard Error|Mean
1257893|NCT00447902|Secondary|Time to New AIDS or AIDS Related Progression Event or Death|Time to new AIDS or AIDS related progression event or death as defined by AIDS defining and/or AIDS-related illnesses.|After Day 1 of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
1256766|NCT00457015|Secondary|Patients With Significant Improvement in Overall Response|"Patients were to be asked to perform an overall response assessment at intervals during the first 4 hours post-dose. Assessments were to be made relative to baseline (ie, immediately before initial dosing) using a 5-category scale. Categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse. Significant improvement is the first time that a patient responded to the overall response assessment as a lot better or resolved."|4 hours post-dose|The time to significant improvement is not provided in this display as the estimated median times were not reached by 240 minutes. Instead, the number of patients with significant improvement is provided per treatment arm.|||participants|||Number
1256767|NCT00457015|Secondary|Treatment Outcome Score at 4 Hours Post-Dose|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100; best value]to significant worsening [-100; worst value]). Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose|Patients were excluded from this analysis if they did not have data for the endpoint being analyzed. The reasons for patients being excluded from this analysis are for ecallantide: 1 patient treated for severe upper airway compromise and for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data.|||units on a scale||Standard Deviation|Mean
1256768|NCT00457015|Primary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose|The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose|Patients were excluded from the analysis if they did not have data for the endpoint being analyzed. Reasons for patients being excluded are for ecallantide: 1 patient treated for severe upper airway compromise; for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data. Best score=0.0; worst score=3.0.|||units on a scale||Standard Deviation|Mean
1256769|NCT00457002|Secondary|Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants|Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug and had available laboratory measurements.|||participants|||Number
1256770|NCT00457002|Secondary|Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements|Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.|Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)|Participants who received at least one dose of study drug, and had available laboratory results associated with the event and treatment group.|||participants|||Number
1256771|NCT00457002|Secondary|Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants|Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.|Day 1 to last dose of study drug plus 2 days|MI and thrombocytopenia categories: participants who received at least one dose of study drug. MI or stroke category: treated participants except those who did not have MI and had an inadequate assessment for stroke. Stroke category: treated participants except those with an inadequate assessment for stroke during the treatment period.|||Event Rate (%)||95% Confidence Interval|Number
1256772|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants|Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.|||participants|||Number
1256773|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants|Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.|||participants|||Number
1256824|NCT00456807|Primary|Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples|Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.|At Month 12 and Month 18 after first vaccination|Analysis was performed on the Total Vaccinated Cohort, only on those subjects from the Cervarix group with CVS sample results available.|||correlation coefficient|||Number
1256774|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants|Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.|||participants|||Number
1256775|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants|Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.|||participants|||Number
1256776|NCT00457002|Secondary|Mean Change From Baseline in Heart Rate in Treated Participants|Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.|||bpm||Standard Deviation|Mean
1256777|NCT00457002|Secondary|Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period|Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.|||mmHg||Standard Deviation|Mean
1256778|NCT00457002|Secondary|Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period|Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.|||mmHg||Standard Deviation|Mean
1256779|NCT00457002|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants|Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.|Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)|Participants who received at least one dose of study drug were analyzed (As Treated population).|||participants|||Number
1256780|NCT00457002|Secondary|Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period|A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
1256781|NCT00457002|Primary|Incidence of All Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of drug to last dose of drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.|||Event Rate (%)||95% Confidence Interval|Number
1256827|NCT00456807|Primary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values|Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.|||Subjects|||Number
1256782|NCT00457002|Primary|Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.|||Event Rate (%)||95% Confidence Interval|Number
1256783|NCT00457002|Primary|Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.|||Event Rate (%):||95% Confidence Interval|Number
1256784|NCT00457002|Primary|Incidence of Major Bleeding During the Treatment Period in Treated Participants|Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.|||Event Rate (%)||95% Confidence Interval|Number
1256785|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment, were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
1256786|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period|Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment period, were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
1256787|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
1256788|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
1256789|NCT00457002|Secondary|Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
1256790|NCT00457002|Secondary|Incidence of Adjudicated PE With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
1256791|NCT00457002|Secondary|Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
1256792|NCT00457002|Secondary|Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
1256793|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
1256794|NCT00457002|Secondary|Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|All Randomized Participants.|||Event Rate (%)||95% Confidence Interval|Number
1256795|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
1256796|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
1256825|NCT00456807|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies|Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.|At Month 12 and Month 18 after first vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. None of the subjects in the Placebo Group had detectable antibodies against HPV-16 at Months 12 and 18 and against HPV-18 at Month 12.|||Titer||95% Confidence Interval|Geometric Mean
1256797|NCT00457002|Secondary|Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period|Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
1256798|NCT00457002|Secondary|Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants|Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).|Day 1 to last dose of parenteral study drug plus 1 day|Secondary Efficacy Evaluable includes those who have an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event is not inadequate; or those with an adjudicated event that is part of the composite endpoint.|||Event Rate (%)||95% Confidence Interval|Number
1256799|NCT00457002|Secondary|Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants|Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).|Day 1 to last dose of parenteral study drug plus 1 day|Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of parenteral treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had adjudicated and evaluable ultrasound at end of parenteral treatment, or had an adjudicated VTE-related death during the Parenteral Treatment Period.|||Event rate (%)||95% Confidence Interval|Number
1256800|NCT00457002|Primary|Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population|VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of intended treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had an adjudicated and evaluable ultrasound at end of intended treatment, or had an adjudicated total VTE-related death.|||Event rate (%)||95% Confidence Interval|Number
1256801|NCT00456989|Secondary|Response Rate|Data not analyzed, PI left institution|7 years|||||||
1256802|NCT00456989|Primary|Maximum Tolerated Dose and Toxicity Profile|There is no data to report. Data for this trial was not analyzed, the PI left institution.|2 years|||||||
1256803|NCT00456885|Secondary|REE|Resting Energy Expenditure|16 weeks from the start of each treatment period.||||Kilocalories||95% Confidence Interval|Mean
1256804|NCT00456885|Secondary|HOMA Score||16 weeks from the start of each treatment period.||||Ratio fasting glucose to insulin||95% Confidence Interval|Mean
1256805|NCT00456885|Secondary|Change in Two Hour Glucose||16 weeks from the start of each treatment period.||||mg/dl||95% Confidence Interval|Mean
1256806|NCT00456885|Secondary|Change in Fasting Glucose||16 weeks from the start of each treatment period.||||mg/dl||95% Confidence Interval|Mean
1256807|NCT00456885|Secondary|Change in Insulin||16 weeks from the start of each treatment period.||||microunits per liter||95% Confidence Interval|Mean
1256808|NCT00456885|Secondary|Adiponectin||16 weeks after the beginning of each treatment||||microgram per ml||95% Confidence Interval|Mean
1256809|NCT00456885|Secondary|Diastolic Blood Pressure||16 weeks after the beginning of each treatment||||mm of mercury||95% Confidence Interval|Mean
1256810|NCT00456885|Secondary|Changes in Leptin||16 weeks from the start of each treatment period.||||ng/ml||95% Confidence Interval|Mean
1256811|NCT00456885|Secondary|Changes in Body Composition|Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat.|16 weeks after the beginning of each treatment||||per cent||95% Confidence Interval|Mean
1256826|NCT00456807|Primary|Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titers are presented as Geometric Mean Titers (GMTs).|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.|||Titer||95% Confidence Interval|Geometric Mean
1256816|NCT00456846|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.|Day 1 to Day 940|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||participants|||Number
1256817|NCT00456846|Secondary|Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug|The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Day 1 of study drug to Day 940; data cut off 31 May 2013|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||participants|||Number
1256818|NCT00456846|Secondary|Patient Survival|Participant survival was the time from the first dose of study drug to participant death from any cause. Participants who did not die were censored at the last known time the participant was alive.|Study start until death, or until data cut-off 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug.|||months||95% Confidence Interval|Median
1256819|NCT00456846|Secondary|Duration of Response Based on Investigator Assessment|Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).|Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug.|||months||95% Confidence Interval|Median
1256820|NCT00456846|Secondary|Duration of Response Based on Independent Reviewer Assessment|Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. CR and PR were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).|Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months|Treated Population: The Treated population with a confirmed complete response or partial response.|||months||95% Confidence Interval|Median
1256821|NCT00456846|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause), whichever occurred first. Participants who did not have progression or did not die were censored at the last known time the participant was progression free. Participants who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
1256822|NCT00456846|Secondary|Percentage of Participants With Disease Control|Disease control was defined as stable disease (SD) for ≥ 16 weeks or complete response (CR) or partial response (PR). Response was evaluated by the Investigator and by an independent reviewer using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0. See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Every 8 weeks from study start until disease progression; Up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1256823|NCT00456846|Primary|Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers|Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits|Every 8 weeks from study start until disease progression; Up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1258265|NCT00445302|Primary|Dose-Normalized Maximum Concentration of Plerixafor (Cmax)|Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.|Pre-dose of plerixafor to 24 hours post-plerixafor|Intent-to-treat population|||ng/mL/ug||Standard Deviation|Mean
1256828|NCT00456807|Primary|Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18|"The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells.~An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification."|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.|||cells per million B-cells||95% Confidence Interval|Geometric Mean
1256829|NCT00456807|Primary|Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines|The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.|||cells per million CD4/CD8 T-cells||95% Confidence Interval|Geometric Mean
1256830|NCT00456755|Secondary|Quality of Life (Difference Between Baseline and Week 4)|SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health).|4 week|ITT|||Unit Score||Standard Deviation|Mean
1256831|NCT00456755|Primary|Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4|The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used.|4 week||||Unit Score||Standard Deviation|Mean
1256832|NCT00456625|Secondary|Number of Participants Reporting Any Serious Adverse Events (SAEs).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Up to 1 month after the challenge dose.||||participants|||Number
1256833|NCT00456625|Secondary|Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~An AE is considered severe if it prevents normal, everyday activities."|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.||||participants|||Number
1256834|NCT00456625|Primary|Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values|The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.|One month after the hepatitis B vaccine challenge dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (including all evaluable subjects who had received the challenge dose of hepatitis B vaccine and for whom immunogenicity data were available at the post-hepatitis B vaccine challenge dose timepoint).|||participants|||Number
1256835|NCT00456612|Primary|Progression Free Survival||consent to prgression or death|||||||
1256836|NCT00456612|Secondary|Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.||1year|||||||
1256837|NCT00456612|Primary|The Percent Progression -Free Survival at 6 Months Will be Tabulated||6 months|||||||
1256838|NCT00456599|Secondary|Overall Survival|Percent overall survival was calculated for all evaluable patients.|5 years|Of the 71 eligible patients, 68 were evaluable for overall response (1 patient was removed from study during cycle 1 for noncompliance, and 2 additional patients withdrew for reasons not related to toxicity or progression).|||months||95% Confidence Interval|Median
1256839|NCT00456599|Secondary|Time to Treatment Failure|Median time for disease recurrence after surgery.|2 years|43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.|||months||Full Range|Median
1256840|NCT00456599|Primary|Two-year Disease Free Survival.|The percent of patients alive and disease-free at two years.|two years|43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.|||percentage of patients||95% Confidence Interval|Number
1256841|NCT00456547|Secondary|Antithrombin III Levels at 2 Hours Post Delivery|Antithrombin III is a glycoprotein and is the major inhibitor of thrombin and other activated clotting factors, including factors IX, X, XI, and XII, the cofactor through which heparin exerts its effect. We hypothesized that women with continued bleed following delivery and require a hysterectomy will demonstrate a greater reduction in antithrombin III that women undergoing cesarean delivery.|2 hours after delivery||||percentage of normal antithrombin III||Standard Deviation|Mean
1256842|NCT00456547|Secondary|Plasminogen Levels 2 Hours After Delivery|Plasminogen is converted to plasmin when the coagulation system is activated. We hypothesized that plasminogen should be decrease more in women with continued bleeding following delivery requiring hysterectomy will demonstrated a greater decrease in plasminogen than following cesarean delivery.|2 hours after delivery||||mg/dL||Standard Deviation|Mean
1256843|NCT00456547|Secondary|Platelet Counts at 2 Hours After Delivery|Platelets are decreased in subjects with consumptive coagulopathies which is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases. We hypothesized that women who require hysterectomy for postpartum bleeding are more likely to have decreased platelet counts than matched controls that underwent cesarean delivery.|2 hours after delivery||||platelets (*1000 per liter)||Standard Deviation|Mean
1256858|NCT00456521|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1256844|NCT00456547|Primary|Fibrinogen Level at 2 Hours After Delivery|Fibrinogen level decrease is a marker of consumptive coagulation which is is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases or stimulus. We hypothesized that women with excessive bleeding following delivery who require a hysterectomy are more likely to exhibit lower levels of fibrinogen and a consumptive coagulopathy than women following cesarean delivery who do not bleed.|2 hours after delivery||||mg/dL||Standard Deviation|Mean
1256845|NCT00456521|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1256846|NCT00456521|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Scores|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1256847|NCT00456521|Secondary|Change in Food Craving Inventory Sweets Subscale Scores|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1256848|NCT00456521|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1256849|NCT00456521|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mmHg||Standard Error|Least Squares Mean
1256850|NCT00456521|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mmHg||Standard Error|Least Squares Mean
1256851|NCT00456521|Secondary|Change in Fasting LDL Cholesterol||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1256852|NCT00456521|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1256853|NCT00456521|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1256854|NCT00456521|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1256855|NCT00456521|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1256856|NCT00456521|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1256857|NCT00456521|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
1256859|NCT00456521|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||cm||Standard Error|Least Squares Mean
1256860|NCT00456521|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1256861|NCT00456521|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
1256862|NCT00456521|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
1256863|NCT00456508|Secondary|Time to Significant Improvement|"Time to significant improvement in overall response based on the period from 15 minutes after dosing through 4 hrs post dosing. Significant improvement was defined as a response of a lot better or resolved in the overall response assessment."|15 min - 4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score.|||estimated time in minutes||95% Confidence Interval|Median
1256864|NCT00456508|Secondary|Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms|The Treatment Outcome Score (TOS)is a validated measure of response to therapy. Response assessment for each symptom complex (internal head/neck, stomach/GI, genital/buttocks, external head/neck or cutaneous) was to be weighted based on the severity of symptom complexes at baseline. Severity assessment at baseline was rated on a categorical scale (1=mild, 2=moderate, 3=severe) for symptoms at each affected symptom complex. Response assessment of each symptom complex post-dosing relative to baseline used a scale (100=significant improvement, 50=improvement, 0=same). The weighted values were used to calculate the composite TOS. A TOS greater than 0 denotes an improvement in symptoms compared with baseline severity.|4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score.|||scores on a scale||Standard Deviation|Mean
1256865|NCT00456508|Primary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing|Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in MSCS score.|||scores on a scale||Standard Deviation|Mean
1256866|NCT00456495|Secondary|Evaluating Tumor Destruction or Reduction|To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.|2 years||||Participants|||Count of Participants
1256867|NCT00456495|Primary|Number of Patients Assessed for Safety and Tolerability|To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination [anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).|2 years|Analysis was per protocol. Treatment was delivered every 2-4 weeks with good safety and tolerability|||participants|||Number
1256868|NCT00456365|Secondary|Urinary Albumin Excretion||3 years||||mcg/min||Standard Deviation|Mean
1256869|NCT00456365|Secondary|Left Ventricular Mass Index|left ventricular mass index in g/m^2 by MRI|3 years||||g/m^2||Standard Deviation|Mean
1256870|NCT00456365|Secondary|Percentage Change in Total Kidney Volume Corrected for Height||3 years|ITT|||Percent change||Standard Deviation|Mean
1256871|NCT00456365|Primary|Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume|Percent of participants demonstrating 20% or more increase in total kidney volume corrected for height, left ventricular mass index, or urinary albumin excretion over the three year study period|3 years|Intention to treat|||percentage of participants|||Number
1256872|NCT00456261|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||months||95% Confidence Interval|Number
1256873|NCT00456261|Secondary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment||18 months||||percentage of patients||95% Confidence Interval|Number
1256874|NCT00456261|Primary|Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval between the date of treatment initiation and the date of progressive disease|18 months||||months||95% Confidence Interval|Median
1256875|NCT00456014|Secondary|Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase|Mean % improvement from baseline to end of treatment trial using the 24-item Hamilton Depression Rating Scale. Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. The higher the score on the 24-item HDRS, the greater the depression severity. Minimum score on the scale is 0, and maximum score is 74. Subscales are not used for this analysis.|Measured at Week 8|Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. 25 of the 28 SSRI participants completed a trial of escitalopram. 3 of 28 SSRI participants had intolerable side-effects to escitalopram, and were therefore switched to sertraline, and completed a trial of sertraline instead.|||% improvement in depression symptoms||Standard Deviation|Mean
1288242|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1||Month 1||||L||Standard Error|Mean
1256876|NCT00456014|Secondary|Remission of Depressive Symptoms - Tricyclic Phase|Participants who did not achieve remission during the SSRI phase advanced to the tricyclic phase of the study. Participants were treated with either desipramine or nortriptyline. Seven participants started the tricyclic phase. Four completed the tricyclic phase. The completers (n=4) were analyzed for remission status.|Measured over 8 weeks|Depressed participants who did not remit during the SSRI phase advanced to the tricyclic phase of the study. Five participants started treatment with desipramine, one of which also had a trial with nortriptyline. Two participants started tricyclic treatment with nortriptyline.|||participants|||Number
1256877|NCT00456014|Primary|Remission of Depressive Symptoms|Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score <10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase.|Measured at Week 8|"28 of 38 participants completed the SSRI phase. Only those 28 participants were assessed for remission status.~1 participant who is counted as a non-remitter had a spontaneous remission following his MRI."|||participants|||Number
1256878|NCT00455975|Secondary|Overall Tolerability and Toxicity of High-dose Bevacizumab|Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities|18 months|All patients treated with Bevacizumab therapy were assessed for Grade 3/4 toxicities|||participants|||Number
1256879|NCT00455975|Secondary|Objective Response Rate|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR|18 months||||participants|||Number
1256880|NCT00455975|Secondary|Overall Survival (OS)|Measured from date of study entry to date of death due to any cause.|18 months||||months||95% Confidence Interval|Median
1256881|NCT00455975|Primary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|18 months (expected)||||months||95% Confidence Interval|Median
1256882|NCT00455962|Primary|LH Peak in Response to Estrogen Positive Feedback|Estradiol levels are consistently higher in African-American vs Caucasian women across the menstrual cycle. This study was designed to determine if African-American women are more sensitive to estrogen positive feedback to generate the preovulatory LH surge using a controlled estrogen infusion paradigm.|5 days of estradiol and progesterone infusion|Healthy African-American and Caucasian women aged 18-35 with regular ovulatory menstrual cycles.|||IU/L||Standard Error|Mean
1256883|NCT00455923|Secondary|Time to Increase of Study Medication|Data for this outcome measure was not collected.|Up to 6 months|ITT population. Data for this outcome measure was not collected.||||||
1256884|NCT00455923|Secondary|Number of Exacerbations: in Total and by Degree of Severity|Severe exacerbation: needed hospitalization/emergency unit visit. Moderate exacerbation: Needed oral cortico-steroid or adding inhaled Flixotide to maintenance study medicine; decrease in morning or evening peak expiratory flow (PEF) > 30% during ≥ 2 following days from Baseline (Day 0). Mild exacerbation: any night symptoms ≥ 3 consecutive, or night symptoms ≥ 2 consecutive nights in case symptoms have been scored ≥ 2 during at least one night, Day symptoms scored ≥ 2 during ≥ 4 following days, or Day symptoms scored ≥ 3 during ≥ 3 following days, or Day symptoms scored ≥ 4 during ≥ 2 following days, or rescue medication use ≥ 2 occasions per day for ≥ 4 following days, or rescue medication use ≥ 3 occasions per day for ≥ 3 following days, or rescue medication use ≥ 4 occasions per day for ≥ 2 following days, or decrease in morning/evening PEF >20% during ≥ 2 following days from Baseline (Day 0). Number of total exacerbations and severe, moderate and mild exacerbations are presented.|Up to 18 months|ITT Population.|||Exacerbations|||Number
1256885|NCT00455923|Secondary|Number of Symptom-free Days and Nights Without Use of Rescue Medication|The rescue medications used for exacerbations included Ventoline Diskus® 200 mcg/dose inhalations as required and oral Prednisolone 25 mg per day for five days, and when necessary, ten days. Data for this outcome measure was not collected.|Up to 18 months|ITT population. Data for this outcome measure was not collected.||||||
1256886|NCT00455923|Secondary|Change in Bronchial Hyper-responsiveness From Baseline to 18 Months|Data for this outcome measure was not collected.|Baseline (Day 0) to 18 months|ITT population. Data for this outcome measure was not collected.||||||
1256887|NCT00455923|Secondary|Absolute Bronchial Hyper-responsiveness up to 18 Months|Data for this outcome measure was not collected.|Up to 18 months|Data for this outcome measure was not collected.||||||
1256888|NCT00455923|Primary|Number of Participants in Each Arm With a Need for an Increase in Study Medication|During the first 6 months, when the asthma was unstable/uncontrolled, dose of Seretide (Sal/FP) was increased from 50/100 mcg in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). Also, dose of Flixotide (FP only), was increased from 100 mcg to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months. Number of participants in each arm with a need for an increase in study medication are presented.|Up to 18 months|Intent-to-Treat (ITT) Population which comprised of all participants who were randomized and received at least one dose of the study medication.|||Participants|||Count of Participants
1256889|NCT00455858|Secondary|Occurence of Hypoglycaemic Episodes|Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.|weeks 0-20|For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section.|||episodes|||Number
1256890|NCT00455858|Secondary|Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%|Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%|week 12, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.|||percentage of participants|||Number
1288243|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1||Month 1||||L||Standard Error|Mean
1256891|NCT00455858|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20|week 0, week 12, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.|||mg/dL||Standard Deviation|Mean
1256892|NCT00455858|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12|Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline|week 0, week 12|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.|||percentage change in HbA1c||Standard Deviation|Mean
1256893|NCT00455858|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20|Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20|week 0, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.|||percentage change in HbA1c||Standard Deviation|Mean
1256894|NCT00455741|Secondary|18 FDG Uptake at the Hypothalamus During Estrogen Infusion: LH Positive Feedback|Regional cerebral glucose metabolism (rCMRglu) is used as a measure of neuronal metabolic activity and calculated as average uptake (voxels) of 18 flurodeoxyglucose within the region of interest (ROI) and expressed simply as units. Normalized uptake refers to co-registration of the PET with the MRI to provide more accurate anatomic correlates.|24 vs 72 hr|postmenopausal women|||unit||Standard Error|Mean
1256895|NCT00455741|Secondary|18 FDG Uptake at the Pituitary During Estrogen Infusion: LH Positive Feedback|Regional cerebral glucose metabolism (rCMRglu) is used as a measure of neuronal metabolic activity and calculated as average uptake (voxels) of 18 flurodeoxyglucose within the region of interest (ROI) and expressed simply as units. Normalized uptake refers to co-registration of the PET with the MRI to provide more accurate anatomic correlates.|24 hr vs 72 hr|postmenopausal women|||units||Standard Error|Mean
1256896|NCT00455741|Secondary|18 FDG Uptake at the Hypothalamus During Estrogen Infusion: LH Negative Feedback|Regional cerebral glucose metabolism (rCMRglu) is used as a measure of neuronal metabolic activity and calculated as average uptake (voxels) of 18 flurodeoxyglucose within the region of interest (ROI) and expressed simply as units. Normalized uptake refers to co-registration of the PET with the MRI to provide more accurate anatomic correlates.|0 vs 24 hr|postmenopausal women|||units||Standard Error|Mean
1256897|NCT00455741|Secondary|18 FDG Uptake at the Pituitary During Estrogen Infusion: LH Negative Feedback|Regional cerebral glucose metabolism (rCMRglu) is used as a measure of neuronal metabolic activity and calculated as average uptake (voxels) of 18 flurodeoxyglucose within the region of interest (ROI) and expressed simply as units. Normalized uptake refers to co-registration of the PET with the MRI to provide more accurate anatomic correlates.|Baseline vs 24 hr after the onset of steroid infusion|postmenopausal women|||units||Standard Error|Mean
1256898|NCT00455741|Primary|Effect of Aging on Estrogen Positive Feedback on LH|LH area under the curve in response to estrogen positive feedback. Area under the curve was calculated from blood samples drawn every 4 hours from the onset of positive feedback until the end of the study (120 min). The onset of positive feedback is defined as the time when LH first exceeds mean + 2SD of the previous three time points and shows a sustained rise.|Onset of surge (average of 61 hr from beginnning of infusion until the end of the study (120 hr)|NOTE: 2 older and 2 younger postmenopausal women excluded from this analysis as estradiol levels exceeded physiological exposure levels|||IU*hr/L||Standard Error|Mean
1256899|NCT00455741|Primary|Effect of Aging on Estrogen Negative Feedback on LH|Difference between baseline LH (average of 3 samples drawn 15 min apart) and nadir LH based on a 3-point moving average of blood samples drawn every 4 hours over 120 hr, expressed as a percent of baseline (% baseline).|Baseline at 0 time before infusion, nadir occurred between 8 and 60 hr (mean 24 hr)|NOTE: 2 older and 2 younger postmenopausal women excluded from this analysis as estradiol levels exceeded physiological exposure levels|||% change from baseline||Standard Error|Mean
1256900|NCT00455702|Secondary|Treatment Effects on the Positive Syndrome Subscale of the PANSS|The change from baseline to week 8 on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).|Baseline score vs. Week 8 score|One participant from the placebo group was removed from this analysis.|||PANSS Positive Subscale Units||Standard Deviation|Mean
1256901|NCT00455702|Primary|Main Outcome Measure: The Change From Baseline to Week 8 on the SANS|The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).|Baseline score vs. Week 8||||Units on a scale||Standard Deviation|Mean
1256902|NCT00455689|Secondary|Change in Subjective Sleep Quality|Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher score indicates poorer quality sleep), which was administered both before and four weeks after receiving the intervention.|baseline (before receiving intervention) and 4 weeks after receiving intervention||||units on a scale||Inter-Quartile Range|Median
1256903|NCT00455689|Primary|Percent Change in Objective Sleep Efficiency|Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.|baseline (before receiving intervention) and 4 weeks after receiving intervention||||percent change||Inter-Quartile Range|Median
1256904|NCT00455663|Primary|Number of Patients Surviving Without Relapse/Exacerbation|A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision|9 months of treatment 6 months follow up|Number of participants meeting bprs criteria for at least partial remission.scores on 3 of the 4 BPRS psychosis items had to be 4 or lower indicating moderate symptoms only.|||participants|||Number
1256905|NCT00455663|Primary|Social and Occupational Functioning Scale Score|Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 endpoint ls means combining 9 months of treatment and 6 months follow up||||units on a scale||Standard Error|Mean
1256906|NCT00455663|Primary|Positive Symptoms|Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up||||units on a scale||Standard Error|Least Squares Mean
1256907|NCT00455663|Primary|Medication Adherence-pill Count|% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 final score combined for endpoint for 9 months of treatment and 6 months follow up||||percentage of medication taken||Standard Error|Least Squares Mean
1256908|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task|In the Visual spatial working memory (VSWM), participants were asked to place the cursor where the symbol appeared immediately after its display. For 16 additional trials, participants were asked to identify the symbol location after a 30-second delay. During the delay, participants were distracted by being asked to read aloud words appearing on the screen at 2-second intervals. The outcome of interest in this task were the average distance from the target for immediate and delayed recall There is only one outcome measure time frame because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors.|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point||||Distance (in)||Standard Deviation|Mean
1256909|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task|The N-back task with 1- and 2-back parametric conditions was used. During the task, a letter was displayed for 1,500 ms every 2 s with a 500 ms isi. Participants were asked to press the “1” key for letters that corresponded to the letter 1 back for the 1-back condition, the “2” key for the 2-back condition, and the “3” key for nontarget letters. Outcome variable presented is hit reaction time There is only one outcome measure time point because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors.|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point||||ms||Standard Deviation|Mean
1256910|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task|In the 3-card Stroop Task, 3 cards were presented; the 1st contained color names printed in black ink, the 2nd contained colored patches of ink, the 3rd contained color names printed in incongruously colored ink. Participants were asked to read or name as many items as possible in 45 seconds for each condition. Individuals are asked to identify the color of the ink of a word. They may be distracted by the presence of a word that states another color (i.e. the word “blue” written in green ink would require the answer green).The interference score was calculated by dividing the color-word score by the color score. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs varenicline vs pbo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor as well as study period and drug administration sequence as between subject crossover design factors|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point||||score||Standard Deviation|Mean
1256911|NCT00455650|Primary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability|The Continuous Performance Test-Identical Pairs, CPT-IP, Version 4.0 was developed and normed for use in people with schizophrenia and normal controls. This task estimates attention by requiring an individual to push a response key when two identical pairs of shapes or numbers are presented in sequence. Stimuli were presented with increasing cognitive load: 2-, 3-, and 4-digit targets. Outcome variables measured included correct hits, hit reaction time (HRT), errors of commission: false alarms and random errors, and the primary outcome, variability, or standard deviation, of hit reaction time, HRT-SD. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors.|Baseline (week 0), week 1, week 2 and week 3 as one time point (see outcome measure description)||||ms||Standard Deviation|Mean
1256946|NCT00455455|Primary|Corneal Sensitivity|The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|baseline|intent to treat analysis including only participants who had completed the study|||percent CO2||Standard Deviation|Mean
1257568|NCT00450866|Secondary|Toxicity as Measured by NCI CTCAE v3.0|Percent of patients that experience the most common grade 3 and above toxicities possibly related to study drug – to be measured using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.|3 months after treatment|Intention to treat|||percentage of participants|||Number
1256912|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR) in 20- and 26-Gene Model Subgroups|For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.||||||
1256913|NCT00455533|Secondary|Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel|||participants|||Number
1256914|NCT00455533|Secondary|Number of Participants With Course Delay and Reason for Delay for AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC|||participants|||Number
1256915|NCT00455533|Secondary|Reason for First Dose Reduction of Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel|||participants|||Number
1256916|NCT00455533|Secondary|Reason for First Dose Reduction of AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC|||participants|||Number
1256917|NCT00455533|Secondary|Number of Participants by Dose for Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants|||participants|||Number
1256918|NCT00455533|Secondary|Number of Participants by Dose for AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants|||participants|||Number
1256919|NCT00455533|Secondary|On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.|||Participants|||Number
1256920|NCT00455533|Secondary|On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded; n=number of participants with specific laboratory evaluation.|||Participants|||Number
1256921|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations|Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 [log2 normalized intensity units], respectively (corresponding to prevalence rates of 43.3% and 44.3%).|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|For all subgroups other than Beta-III positive/negative subgroup based on a pre-determined cutoff, results were estimated using a cross-validation method (a resampling based technique, making individual sample size [N] not applicable).|||Percentage of Participants||90% Confidence Interval|Number
1256922|NCT00455533|Secondary|On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.|||Participants|||Number
1256923|NCT00455533|Secondary|Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class|MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy|Ixabepilone- and Paclitaxel-treated participants|||Participants|||Number
1256924|NCT00455533|Secondary|Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy||||Participants|||Number
1256925|NCT00455533|Secondary|Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants)|Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive [with 90% confidence interval by Bootstrap method]): Beta 3 Tubulin IHC (45.866 [5, 83.9]); TACC3 mRNA (6.714 [6.312, 7.192]); CAPG mRNA (6.739 [5.728, 7.298]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment|Randomized participants with non-missing pCR and biomarker expressions. n=the number of participants with specific biomarker expression.|||Percentage of Participants||90% Confidence Interval|Number
1256926|NCT00455533|Secondary|Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants|Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized estrogen negative participants with non-missing pCR and biomarker expression|||percentage of participants||90% Confidence Interval|Number
1256927|NCT00455533|Secondary|Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds|Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized participants with non-missing pCR/RCB1 and biomarker expression|||percentage of participants||90% Confidence Interval|Number
1256928|NCT00455533|Secondary|Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds|Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.|: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized participants with non-missing pCR and biomarker expression|||percentage of participants||90% Confidence Interval|Number
1256929|NCT00455533|Secondary|Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1|Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1~Biomarker:Treatment: ER) & reduced model (pCR/RCB1~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) & reduced model (pCR/RCB1~Biomarker+Treatment); 3) contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model (pCR/RCB1~Biomarker:Treatment:ER). A:B represents A,B & A*B.|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.||||participants|||Number
1256930|NCT00455533|Secondary|Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR|Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR~Biomarker:Treatment:estrogen receptor [ER]) & reduced model (PCR~Treatment:ER); 2) the likelihood ratio test between the full model (PCR~Biomarker:Treatment) & reduced model (PCR~Biomarker+Treatment); 3) the contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model(PCR~Biomarker:Treatment:ER). A:B represents A,B & A*B.|pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.||||participants|||Number
1256931|NCT00455533|Secondary|Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1|Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants|||Percentage of Participants||90% Confidence Interval|Number
1256932|NCT00455533|Secondary|Percentage of Participants Requiring Breast Conservation Surgery|Number of randomized participants requiring breast conservation surgery following study treatment.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants|||Percentage of Participants||90% Confidence Interval|Number
1258266|NCT00445263|Secondary|Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.||d30|||||||
1256933|NCT00455533|Secondary|Percentage of Participants Achieving Clinical Objective Response|Clinical response was defined as the number of participants who achieved modified World Health Organization’s tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of >= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm.|after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants|||Percentage of Participants||90% Confidence Interval|Number
1256934|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR)|The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants|||Percentage of Participants||90% Confidence Interval|Number
1256935|NCT00455520|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.|"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline."|Baseline and12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||Scores on a scale||Standard Deviation|Mean
1256936|NCT00455520|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time (hours) indicates improvement."|Baseline and 12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||Hours||Standard Deviation|Mean
1256937|NCT00455520|Secondary|Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|12 week endpoint (change from baseline)|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||scores on a scale||Standard Deviation|Mean
1256938|NCT00455520|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Percentage of patients who reported very much improved (1) or much improved (2) based on an ordinal measure indicating change from start of double blind treatment (on a scale of 7 = Very much worse to 1 = Very much improved)|12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||percentage of patients|||Number
1256939|NCT00455520|Secondary|The Number of Patients Achieving at Least 30% Improvement in Pain Score at Week 12 of the Double-blind Maintenance Period From the Start of the Open Label Period.|The number of patients achieving at least 30% improvement in pain score at Week 12 of the double-blind maintenance period on an 11-point numerical rating scale compared with the start of the open-label period.|Start of Open Label and at 12 weeks of Double Blind|Intent-to-treat analysis set.|||participants|||Number
1256940|NCT00455520|Primary|Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||scores on a scale||Standard Deviation|Mean
1256941|NCT00455455|Primary|Conjunctival Sensitivity|The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|day 7|intent to treat analysis including only participants who had completed the study|||percent CO2||Standard Deviation|Mean
1256942|NCT00455455|Primary|Conjunctival Sensitivity|The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|baseline|intent to treat analysis including only participants who had completed the study|||percent CO2||Standard Deviation|Mean
1256943|NCT00455455|Secondary|Corneal Staining Grade|A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).|day 7|intent to treat analysis including only participants who had completed the study|||units on a scale||Standard Deviation|Mean
1256944|NCT00455455|Primary|Corneal Sensitivity|The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|day 7|intent to treat analysis including only participants who had completed the study|||percent CO2||Standard Deviation|Mean
1256945|NCT00455455|Secondary|Corneal Staining Grade|A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).|baseline|intent to treat analysis including only participants who had completed the study|||units on a scale||Standard Deviation|Mean
1258267|NCT00445263|Secondary|Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus||d30|||||||
1256947|NCT00455429|Secondary|Plasma Concentration of JNJ-26113100|Blood samples for pharmacokinetic (PK) analysis were collected before dosing and at 0.25 to 3 hours after dosing at randomization (Day 1) and Week 3 visit and at 0.25 to 3 hours, 4 to 6 hours, and 7 to 12 hours after dosing at Week 6.|Before dosing on Day 1, Week 3, Week 6; after dosing at 0.25 to 3 hours on Day 1, Week 3, Week 6; after dosing at 4 to 6 hours and 7 to 12 hours on Week 6|Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to treatment groups and received at least 1 dose of study drug. LOCF method was used.|||nanogram (ng)/milli litre (mL)||Standard Deviation|Mean
1256948|NCT00455429|Primary|Percentage of Participants Who Had at Least 1 Worsening AD Event|Percentage of Participants who had at least 1 Worsening AD Event That did not Meet Flare Criteria were assessed. Worsening of AD that did not meet flare criteria was documented. Flare was considered to be present if either of the following criteria were met: 1) IGA was=2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
1256949|NCT00455429|Primary|Number of Flare Occurrences Per Participant|A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0 or 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||participants|||Number
1256950|NCT00455429|Primary|Percentage of Participants Who Had at Least 1 Flare|Percentage of participants who had at Least 1 Flare while on treatment was assessed. A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
1256951|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
1256952|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
1256953|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst Possible Itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
1256954|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of >=25% from the baseline EASI score. An improvement of <25% is considered a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
1256955|NCT00455429|Primary|Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of >=50% from the baseline EASI score. An improvement of <50% is considered a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
1256956|NCT00455429|Primary|Percentage of Participants Achieving Treatment Response as “Clear” or “Almost Clear “in IGA|Percentage of participants achieving treatment response (decrease) in IGA were assessed. IGA is used to assess AD through a 6-point scale (Range=0-5) where, 0=clear (no inflammatory signs of AD), 1=almost clear (just perceptible erythema & perceptible papulation/infiltration), 2=mild (mild erythema & papulation/infiltration), 3=moderate (moderate erythema & papulation/infiltration), 4=severe (severe erythema & papulation/infiltration) & 5=very severe (severe erythema & papulation/infiltration with oozing/crusting). Success is reduction of IGA to 0 or 1. Failure is reduction of IGA to >=2.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
1256957|NCT00455429|Primary|Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours.|Baseline and Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||millimeter (mm)||Standard Deviation|Mean
1256958|NCT00455429|Primary|Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline and Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1256959|NCT00455429|Primary|Investigator's Global Assessment (IGA) Score at Week 6|Participants were reported for IGA. IGA is an overall assessment of Atopic Dermatitis (AD). IGA utilizes a 6-point scale (ranging from 0 to 5): 0=clear (noinflammatory signs of AD), 1=almost clear (just perceptible erythema, and just perceptible papulation/infiltration), 2=mild disease (mild erythema, and mild papulation/infiltration), 3=moderate disease (moderate erythema, and moderate papulation/infiltration), 4=severe disease (severe erythema, and severe papulation/infiltration) and 5=very severe disease (severe erythema, and severe papulation/infiltration with oozing/crusting).|Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. Last Observation Carried Forward (LOCF) method was used.|||participants|||Number
1256960|NCT00455312|Secondary|Incidence of Pulmonary Complications|Defined as patients who exhibit a pulmonary (lung) adverse event.|6 Months||||Participants|||Count of Participants
1256961|NCT00455312|Secondary|Overall Survival|Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive.|1 Year||||Participants|||Count of Participants
1256962|NCT00455312|Secondary|Overall Survival|Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive.|Day 100||||Participants|||Count of Participants
1256963|NCT00455312|Secondary|Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD)|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100||||Participants|||Count of Participants
1256964|NCT00455312|Secondary|Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100||||Participants|||Count of Participants
1256965|NCT00455312|Secondary|Incidence of Late Secondary Malignancies|Defined as patients who have a secondary malignancy (cancer) occurring.|1 Year||||Participants|||Count of Participants
1256966|NCT00455312|Secondary|Incidence of Chronic GVHD|Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.|1 year||||Participants|||Count of Participants
1256967|NCT00455312|Secondary|Incidence of Chronic GVHD|Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.|6 months||||Participants|||Count of Participants
1256968|NCT00455312|Secondary|Incidence of Regimen Related Mortality at 100 Days|all deaths without previous relapse or progression|100 days||||Participants|||Count of Participants
1256969|NCT00455312|Primary|Neutrophil Engraftment|Defined as an absolute neutrophil count (ANC) >5 x 10^8/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. Demonstrate sustained engraftment after a fludarabine based preparative regimen in patients with dyskeratosis congenita followed by hematopoietic cell transplantation.|Day 100||||Participants|||Count of Participants
1256970|NCT00455195|Secondary|Change From Baseline in Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and is standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Change is calculated as the value minus the baseline value. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0 , Week 104|Intent-to-treat population of participants who had valid baseline (Week 0) and Week 104 data.|||units on a scale||Standard Deviation|Mean
1257008|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
1256971|NCT00455195|Secondary|Baseline Values (Week 0) for Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and are standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population of participants with valid baseline (Week 0) PCS surveys.|||units on a scale||Standard Deviation|Mean
1256972|NCT00455195|Primary|Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.|||percent of predicted FVC||Standard Deviation|Mean
1256973|NCT00455195|Primary|Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population|||percent of predicted FVC||Standard Deviation|Mean
1256974|NCT00455195|Secondary|Change From Baseline (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.|||percent of predicted QMT||Standard Deviation|Mean
1256975|NCT00455195|Primary|Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.|||meters||Standard Deviation|Mean
1256976|NCT00455195|Primary|Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population.|||meters||Standard Deviation|Mean
1256977|NCT00455195|Secondary|Baseline Values (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|Week 0|Intent-to-treat population|||percent of predicted QMT||Standard Deviation|Mean
1256978|NCT00455195|Primary|Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|"The numbers of participants who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment with alglucosidase alfa.~Participants with long-term exposure to alglucosidase alfa (those from the Alglucosidase Alfa/Alglucosidase Alfa treatment group) are included. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600)."|Week 0 to 2.5 years|The safety population includes all participants randomized to alglucosidase alfa treatment in AGLU02704 (NCT00158600) who received at least one infusion of alglucosidase alfa.|||participants|||Number
1256979|NCT00455013|Secondary|Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion|Long Term extension was the period from the end of Month 12 to the end of Month 48 post transplantation and the completion of the study 31 July 2012. At any time in the study, participants who were unable to tolerate MMF in the Bela-MMF and Tac-MMF groups could discontinue (DC) MMF and switch to sirolimus and remain in the study and those in the Bela-Siro group who were unable to tolerate sirolimus could DC sirolimus and switch to MMF and remain in the study. Study completion=data base (DB) lock.|End of Month 12 to end of Study (Month 48)|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form|||participants|||Number
1288244|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48||Month 48||||L||Standard Error|Mean
1256980|NCT00455013|Secondary|Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|Participants were considered corticosteroid-free at Months 24, 36, and 48 if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants were considered CNI-free at Months 24, 36, and 48 if they were not receiving CNI during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor.|Months 24, 36, 48|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.|||participants|||Number
1256981|NCT00455013|Secondary|Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|In the LTE, a participant was considered corticosteroid-free if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively.|End of Month 12 to end of Long Term Extension (Year 4)|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.|||participants|||Number
1256982|NCT00455013|Secondary|Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension|GFR was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Age in years, Alb = Albumin in g/dL; SCr = in mg/dL; BUN =Blood urea nitrogen in mg/dL. Intent to Treat population is defined as all participants randomized and transplanted.|Months 24, 36 and 48 post transplantation|N=All participants who were randomized, transplanted, in the LTE and had data available at the specific time point.|||mL/Min/1.73m^2||Standard Deviation|Mean
1256983|NCT00455013|Secondary|Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.|End of Month 12 to end of Long Term Extension (Year 4)|N=participants randomized and transplanted and in LTE.|||participants|||Number
1256984|NCT00455013|Secondary|Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension|AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.|End of Month 12 to end of Month 48 Post Transplantation|All participants who completed the short term (ST) period, were eligible and accepted to enter the LTE by signing a new informed consent form.|||participants|||Number
1256985|NCT00455013|Secondary|Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population|Participants were said to be CNI-free at Month 6 or 12 if they were not receiving a CNI during Day 141 to Day 196, or Day 337 to Day 392. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. Participants were corticosteroid-free (CS-free) at Month 6 if they were not receiving corticosteroids for > 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Day 1 was day of transplantation. Intent to treat population included all randomized and transplanted participants.|Day 1 to Month 12 post transplantation|Analysis on both CNI-free and CS-free participants based on all followed up at least 151 days for Month 6 or 347 days for Month 12. One participant in the tacrolimus arm was counted as CNI-free since he discontinued tacrolimus on Day 2 of transplant and no data were available regarding immunosuppressive therapy after discontinuation.|||participants|||Number
1256986|NCT00455013|Secondary|Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population|Participants were said to be corticosteroid-free at Month 6 if they were not receiving corticosteroids for greater than (>) 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Intent to treat population included all randomized and transplanted participants.|Day 1 through Month 12|For 95% CI within each group, normal approximation was used if N greater than, equal to (>=)5. Otherwise, exact method was used. Numbers of participants analyzed at Month 6 in each arm were 33, 26, 30 and numbers of participants analyzed at Month 12 were 32, 26, 30, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.|||participants|||Number
1256987|NCT00455013|Secondary|Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population|Blood urea nitrogen (BUN) in mg/dL; Albumin (Alb) in g/dL;Serum creatinine (SCr) in mg/dL; Age in years. Glomerular filtration rate (GFR) was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Intent to Treat (ITT) population is defined as all participants randomized and transplanted.|Months 3, 6 and 12 post transplantation|Month 12 n presented above. Calculated GFR, values >180 mL/min/1.73 m2 (beyond upper limit of biologic plausibility)were truncated at 180 mL/min/1.73 m^2. Based on median (SD) GFR of 83 (50).|||mL/min/1.73m^2||Standard Deviation|Mean
1256988|NCT00455013|Secondary|Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population|Baseline (BL) was value obtained day prior to transplantation. Lipid values measured in milligrams/deciliter (mg/dL) included: high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), non-HDL cholesterol (non-HDL-C), total cholesterol (TC), triglycerides. Intent to treat population included all participants randomized and transplanted.|Baseline to Month 12|33, 26, 30 participants were included in the ITT population. Number of participants analyzed for HDL-C = 26, 22, 26; non-HDL-C = 26, 22, 26; LDL-C = 20, 14, 21; TC = 26, 22, 26; triglycerides = 20, 14, 21, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.|||mg/dL||Standard Deviation|Mean
1256989|NCT00455013|Secondary|Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population|Participants using > = 1 antihyperlipidemic medication at Month 12.|Month 12|Analysis based on all participants who were followed up at least 364 days.|||participants|||Number
1256990|NCT00455013|Secondary|Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population|Systolic, diastolic and mean arterial blood pressures were measured in millimeters of mercury (mm Hg). Baseline was defined as value obtained before transplantation. Intent to treat population included all participants randomized and transplanted.|Baseline and 12 months post transplantation|Number analyzed at baseline presented above. Number analyzed at Month 12: 28, 22, 29 in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF treatment arms,respectively. Measurements obtained immediately after drug infusion were excluded from analysis.|||mm Hg||Standard Deviation|Mean
1256991|NCT00455013|Secondary|Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population|Baseline was defined as day prior to transplantation. Number of anti-hypertension medications taken were categorized from 1 to 6 and greater than (>)6. Intent to treat population included all participants randomized and transplanted.|Baseline and Month 12|ITT population, 33, 26, 30 for each arm, respectively, was used for each time point (baseline and Month 12). At baseline, 2 participants in each arm were not using at least one medication. 8, 6, and 10 participants in each arm respectively, were not using at least one medication at Month 12.|||participants|||Number
1256992|NCT00455013|Secondary|Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population|"Baseline defined as day before transplantation. A participant who did not have diabetes prior to randomization and received an antidiabetic medication for a duration of at least 30 days or a participant who meets the following criteria and did not have diabetes prior to randomization: Symptoms of diabetes plus casual plasma glucose (PG) concentration ≥ 200 mg/dL (11.1 mmol/L); or fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L); or 2-hour PG ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test and a confirmatory laboratory test based on measurements of venous PG must have been done on another day in the absence of unequivocal hyperglycemia accompanied by acute metabolic decompensation.~Intent to treat population included all participants randomized and transplanted."|Baseline to Month 12||||participants|||Number
1256993|NCT00455013|Secondary|Number of Participants With Delayed Graft Function - Intent to Treat Population|Delayed graft function (DGF) is defined as participant requiring dialysis within the first week (Day 1-8) post transplantation. Participants losing their graft less than 48 hours post transplant and receiving chronic dialysis were not considered as having DGF. Day 1 was day of transplantation. Intent to treat population defined as all participants randomized and transplanted|From Day 1 up to and including Day 8 post transplantation||||participants|||Number
1256994|NCT00455013|Secondary|Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population|Subjects with graft loss or death prior to Month 12 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.|Day 1 up to Month 12||||participants|||Number
1256995|NCT00455013|Secondary|Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population|Participants with graft loss or death prior to Month 6 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.|Day 1 up to Month 6|Intent to treat population included all randomized and transplanted participants.|||participants|||Number
1256996|NCT00455013|Secondary|Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.|Day 1 to Month 6 and Month 12 post transplantation|Participants surviving with a functioning graft were 30, 24, 30 in belatacept/MMF, belatacept/sirolimus, tacrolimus/MMF arms, respectively. Participant who died had functioning graft at time of death.|||participants|||Number
1256997|NCT00455013|Secondary|Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population|AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.|Day 1 to Month 12 post transplantation|For 95% CI within each group, normal approximation was used if N greater than, equal to 5. Otherwise, exact method was used.|||participants|||Number
1257007|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||µg/mL||95% Confidence Interval|Geometric Mean
1256998|NCT00455013|Primary|Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population|AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant treated for episode. Day 1=transplantation. Banff 97 working classification of kidney transplant pathology: Type I=tubulointerstitial AR without arteritis (IA: interstitial infiltration with >25% of parenchyma affected and moderate tubulitis with >4 mononuclear cells/tubular cross section; IB: >10 mononuclear cells; Type II vascular AR with (IA) intimal arteritis (IIA=mild - moderate; IIB=severe; Type III=severe rejection with transmural arterial changes, necrosis of smooth muscle cells.|Day 1 to Month 6 post-transplantation|Participants with more than one episode of AR were counted once only and the episode with the worst grade was used. For 95% Confidence Interval (CI) within each group, normal approximation was used if N greater than, or equal to (>=) 5. Otherwise, exact method was used. ITT population defined as all randomized and transplanted participants.|||participants|||Number
1256999|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Within (31-Days) at Year 2|The Total Cohort Year 2 included all vaccinated subjects in the booster study 104056 who came back for the Year 2 follow-up and also all subjects of NoBoost Group who were enrolled and vaccinated at Visit 2 (i.e. 40-43 months of age).|||Subjects|||Number
1257000|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 48 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)|||Subjects|||Number
1257001|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 24 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)|||Subjects|||Number
1257002|NCT00454987|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 12 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)|||Subjects|||Number
1257003|NCT00454987|Primary|Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies|Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1257004|NCT00454987|Primary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL|The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
1257005|NCT00454987|Primary|Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies|Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects||95% Confidence Interval|Number
1257006|NCT00454987|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)|The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
1257621|NCT00450450|Secondary|Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)|Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.|Up to 3 months|One patient is inevaluable and is excluded from analysis.|||Percentage of patients|||Number
1257009|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
1257010|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
1257011|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjetcs|||Number
1257012|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
1257013|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||µg/mL||95% Confidence Interval|Geometric Mean
1257014|NCT00454987|Primary|Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Subjects|||Number
1257015|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||µg/mL||95% Confidence Interval|Geometric Mean
1257016|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
1257017|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
1257018|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
1257019|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
1257020|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
1258268|NCT00445263|Secondary|Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography||until the exit from the hospital and at d30.|||||||
1257021|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||µg/mL||95% Confidence Interval|Geometric Mean
1257022|NCT00454987|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Subjects|||Number
1257023|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Titre||95% Confidence Interval|Geometric Mean
1257024|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
1257025|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
1257026|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Titre||95% Confidence Interval|Geometric Mean
1257027|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Titre||95% Confidence Interval|Geometric Mean
1257028|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
1257029|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
1257030|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
1257031|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
1257032|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for the serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Titre||95% Confidence Interval|Geometric Mean
1257622|NCT00450450|Secondary|Estimated Graft Failure Rate|Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.|Up to 10 years|One patient is inevaluable for EFS on experimental arm and is excluded from analysis.|||Percentage of patients|||Number
1257033|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Subjects|||Number
1257034|NCT00454987|Primary|Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Subjects|||Number
1257035|NCT00454909|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits||From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257036|NCT00454909|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257037|NCT00454909|Secondary|Number of Subjects With New Onset Chronic Illness(es) (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257038|NCT00454909|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257039|NCT00454909|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0–30) follow-up period after vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257040|NCT00454909|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as orally temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257041|NCT00454909|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257042|NCT00454909|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|At Day 0 (PRE) and Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days|||Titers||95% Confidence Interval|Geometric Mean
1257043|NCT00454909|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|At Day 0 (PRE) and Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.|||Participants|||Count of Participants
1257044|NCT00454909|Primary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|At Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.|||Participants|||Count of Participants
1257045|NCT00454909|Primary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|At Day 0 (PRE)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.|||Participants|||Count of Participants
1257046|NCT00454857|Secondary|Number of Participants Requiring Splenectomy|The number of participants who required a splenectomy during the 12-month prospective phase of the study.|12 months|All enrolled participants who completed at least 1 observational study visit during the prospective phase.|||Participants|||Number
1257047|NCT00454857|Secondary|Duration of Exposure to ITP Medication|Duration of exposure to each ITP medication measured from enrollment until the end of the 12-month data collection phase.|12 months (prospective data collection phase)|All enrolled participants who completed at least 1 observational study visit during the prospective phase. N=number of participants using each medication.|||Months||Standard Deviation|Mean
1257048|NCT00454857|Secondary|Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase|The number of participants who received drug therapies for the treatment of ITP during the prospective phase of the study. Use of multiple medications by the same participants is possible.|12 months (prospective data collection phase)|All enrolled participants who completed at least 1 observational study visit during the prospective phase.|||Participants|||Number
1257049|NCT00454857|Secondary|Change From Baseline to Month 12 in Treatment Satisfaction|Participant satisfaction with treatment was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), an 11-item questionnaire providing scores on four scales – side effects, effectiveness, convenience and global satisfaction. TSQM Scale scores range from 0 to 100 with higher scores indicating more satisfaction with treatment.|Baseline to Month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.|||Units on a scale||Standard Deviation|Mean
1257050|NCT00454857|Secondary|Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0).|Baseline to Month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all subjects who completed at least one questionnaire during the prospective observation period.|||Units on a scale||Standard Deviation|Mean
1257051|NCT00454857|Secondary|Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)|The Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. Scores for each scale range from 0 (worst) to 100 (best).|Baseline to month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.|||Units on a scale||Standard Deviation|Mean
1257052|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date.|The number of participants who received ITP therapies for treatments with unknown starting date during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
1257053|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment.|The number participants who received ITP therapies as seventh or greater-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
1257054|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment.|Assessed the number of participants who received ITP therapies for sixth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
1257055|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment|The number of participants who received ITP therapies for fifth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
1257056|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment.|The number of participants who received ITP therapies for fourth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
1257057|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Third-line Treatment.|The number of participants who received ITP therapies for third-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
1257058|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Second-line Treatment.|The number of participants who received ITP therapies for second-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
1257059|NCT00454857|Primary|Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment|The number of participants who received ITP therapies for first-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
1257060|NCT00454818|Other Pre-specified|Phase 1 and Phase 2: All Subject Deaths Through 36 Months|"All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial. Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months. Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation. These deaths are therefore included under Deaths within 12 months but also listed as Cardiovascular deaths in long-term follow-up. Accordingly, the number of Cardiovascular deaths in long-term follow-up for the placebo group is greater than the number of Deaths after 12 months, as 2 of the deaths occurred within 12 months but after early termination."|36 months|"Includes all participants enrolled in the Phase 1 or Phase 2 trial. Events occurring after early termination are listed under long-term follow-up. The number of CV deaths in long-term follow-up for the placebo group is greater than the number of Deaths after 12 months, as 2 deaths occurred within 12 months but after early termination."|||participants|||Number
1257061|NCT00454818|Other Pre-specified|Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12|Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||mL||Standard Deviation|Mean
1257062|NCT00454818|Primary|Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6|Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||mL||Standard Deviation|Mean
1257063|NCT00454818|Primary|Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6|Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||Percentage of blood ejected from the LV||Standard Deviation|Mean
1257064|NCT00454818|Other Pre-specified|Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12|Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||Percentage of blood ejected from the LV||Standard Deviation|Mean
1257065|NCT00454818|Post-Hoc|Phase 2: Selected Clinical Outcomes During 12-month Study Period|Incidences of key clinical endpoints as adjudicated by the blinded Clinical Endpoint Committee.|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||percentage of participants|||Number
1257066|NCT00454818|Other Pre-specified|Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12|NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.|||pg/mL||Standard Deviation|Mean
1257067|NCT00454818|Other Pre-specified|Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12|Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. Peak VO2 data were not available for one patient in the placebo group.|||mL/kg per minute||Standard Deviation|Mean
1257068|NCT00454818|Other Pre-specified|Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12|The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||meters||Standard Deviation|Mean
1257069|NCT00454818|Other Pre-specified|Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score|"NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).~The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.~For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms."|Baseline to 12 months|This analysis was performed on the intention to treat population, which included all patients randomized to treatment.|||units on a scale||Standard Deviation|Mean
1257070|NCT00454818|Other Pre-specified|Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months|Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||days||Standard Deviation|Mean
1257071|NCT00454818|Primary|Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6|NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.|||pg/mL||Standard Deviation|Mean
1257072|NCT00454818|Primary|Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6|Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||mL/kg per minute||Standard Deviation|Mean
1257073|NCT00454818|Primary|Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6|The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||meters||Standard Deviation|Mean
1257074|NCT00454818|Primary|Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score|"NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).~The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.~For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms."|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||units on a scale||Standard Deviation|Mean
1257075|NCT00454818|Primary|Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months|Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.|6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||days||Standard Deviation|Mean
1257076|NCT00454818|Primary|Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months|"Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit. The category of TEAEs related to the investigational product (IP) includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP."|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||percentage of participants|||Number
1257077|NCT00454805|Secondary|Duration of Clinical Benefit|Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months.|Every 8 weeks until progression or discontinuation||||Days||Standard Deviation|Mean
1257078|NCT00454805|Secondary|Clinical Benefit Rate|"Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months.~The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off."|Every 8 weeks until progression or discontinuation||||Ratio|||Number
1257079|NCT00454805|Secondary|Duration of Response|Number of days from date of response (complete/partial based on RECIST) to date of progression|Every 8 weeks until progression or discontinuation||||Days||Full Range|Median
1257080|NCT00454805|Secondary|Objective Response Rate|"Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as:~Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.~Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase.~Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.||||Participants|||Number
1257081|NCT00454805|Primary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.||||Days||95% Confidence Interval|Median
1258269|NCT00445263|Primary|Mortality, Myocardial Infarction and Revascularization in Emergency||d30||||participants|||Number
1257082|NCT00454779|Secondary|Overall Survival (OS) for the Second-line Treatment|Time from the first dose of panitumumab monotherapy to the date of death during the entire study|Until death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy|||Months||95% Confidence Interval|Median
1257083|NCT00454779|Secondary|Time to Response (TTR) During the Second-line Treatment Phase|Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response|||Weeks||Standard Deviation|Mean
1257084|NCT00454779|Secondary|Duration of Response (DOR) During the Second-line Treatment Phase|Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response|||Months||95% Confidence Interval|Median
1257085|NCT00454779|Secondary|Rate of Disease Control (RDC) During the Second-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy|||Percentage of Participants||95% Confidence Interval|Mean
1257086|NCT00454779|Secondary|Overall Response Rate (ORR) During the Second-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy|||Percentage of Participants||95% Confidence Interval|Mean
1257087|NCT00454779|Secondary|Progression Free Survival (PFS) During the Second-line Treatment Phase|The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy|||Months||95% Confidence Interval|Median
1257088|NCT00454779|Secondary|Overall Survival (OS) for the First-line Treatment|Time from the date of randomization to the date of death during the entire study|Until death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)|||Months||95% Confidence Interval|Median
1257089|NCT00454779|Secondary|Time to Response (TTR) During the First-line Treatment Phase|Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response|||Weeks||Standard Deviation|Mean
1257090|NCT00454779|Secondary|Duration of Response (DOR) During the First-line Treatment Phase|Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response|||Months||95% Confidence Interval|Median
1257101|NCT00454649|Secondary|Plasma Clearance (CL) for Cisplatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
1257091|NCT00454779|Secondary|Rate of Disease Control (RDC) During the First-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.|Every 6 weeks until disease progression or death, up to 67 months|all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review|||Percentage of Participants||95% Confidence Interval|Mean
1257092|NCT00454779|Secondary|Overall Response Rate (ORR) During the First-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.|Every 6 weeks until disease progression or death, up to 67 months|all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review|||Percentage of Participants||95% Confidence Interval|Mean
1257093|NCT00454779|Primary|Progression Free Survival (PFS) During the First-line Treatment Phase|The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)|||Months||95% Confidence Interval|Median
1257094|NCT00454649|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks|Population included all participants who received at least 1 dose of study medication and had at least 1 target lesion according to RECIST and a baseline assessment of disease.|||Percentage of Participants|||Number
1257095|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Pemetrexed|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1257096|NCT00454649|Secondary|Plasma Clearance (CL) for Pemetrexed|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
1257097|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Pemetrexed||0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
1257098|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pemetrexed||0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1257099|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1257100|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Cisplatin|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1257102|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Cisplatin||Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
1257103|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Cisplatin||Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1257104|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin|AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1257105|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Carboplatin|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1257106|NCT00454649|Secondary|Plasma Clearance (CL) for Carboplatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
1257107|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Carboplatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
1257108|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Carboplatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1257109|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1257110|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Gemcitabine|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1257111|NCT00454649|Secondary|Plasma Clearance (CL) for Gemcitabine|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
1257112|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
1257113|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1257114|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1257115|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Capecitabine|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1257153|NCT00454363|Secondary|Plasma Trough Level of GW786034||Baseline and day 28|||||||
1257696|NCT00449787|Secondary|Patient Satisfaction|"At the 48 hour assessment, patients were asked, The next time you go to an emergency room with a headache, do you want to receive the same medication. This outcome tabulates the number of affirmative responses."|48 hours after ER discharge||||participants|||Number
1257116|NCT00454649|Secondary|Apparent Oral Clearance (CL/F) for Capecitabine|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Liter/hr||Standard Deviation|Mean
1257117|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Capecitabine||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).|||ng/mL||Standard Deviation|Mean
1257118|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Capecitabine||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1257119|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1257120|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Docetaxel|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1257121|NCT00454649|Secondary|Plasma Clearance (CL) for Docetaxel|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
1257122|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Docetaxel||0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
1257123|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Docetaxel||0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1257124|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1257125|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Paclitaxel|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1257126|NCT00454649|Secondary|Plasma Clearance (CL) for Paclitaxel|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
1257127|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Paclitaxel||0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
1257128|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Paclitaxel||0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1257129|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1257130|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1257131|NCT00454649|Secondary|Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Liter/hour (L/hr)||Standard Deviation|Mean
1257132|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Axitinib (AG-013736)||0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).|||ng/mL||Standard Deviation|Mean
1257133|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)||0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1257134|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1257135|NCT00454649|Primary|Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy|MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]|Safety analysis population included all enrolled participants who received at least 1 dose of study medication.|||mg BID|||Number
1257136|NCT00454636|Secondary|Time to Response|Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.|||days||Standard Deviation|Mean
1257137|NCT00454636|Secondary|Duration of Response|Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.|||days||Standard Deviation|Mean
1257138|NCT00454636|Secondary|Overall Survival (OS)|OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
1257283|NCT00453921|Primary|Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)|Continuous Performance Test, Distractibility Condition (Reaction Time in msecs) (range: 0-800). Higher score is worse performance.|post-intervention (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
1257139|NCT00454636|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
1257140|NCT00454636|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.|Approximately 3.25 years|Intent-to-Treat (ITT) population: included all participants who received at least one dose of study medication and had baseline and at least one subsequent tumor assessment.|||percentage of participants||95% Confidence Interval|Number
1257141|NCT00454636|Primary|Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)||Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.|||percentage of participants|||Number
1257142|NCT00454584|Secondary|Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)|The difference between the PASI score at Week 12 and that achieved after 12 weeks of retreatment. The PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst).|Up to Week 52. Retreatment may occur anytime between Week 16 and Week 40 depending on time of losing PGA response. Hence end of 12 weeks of retreatment would be between Week 28 and Week 52, inclusive.|Participants who were randomized to ustekinumab, had a PGA score less than or equal to 2 at Week 12, and were retreated upon losing PGA response (PGA greater than or equal to 3).|||Score on a scale||Standard Error|Mean
1257143|NCT00454584|Secondary|Number of Participants Achieving a Greater Than or Equal to 90 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 90) Score at Week 12|Number of participants achieving greater than or equal to 90 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst).|Baseline and Week 12|Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. A participant is considered a non-responder if the participant has used any pre-specified prohibited medications, discontinued due to lack of efficacy, or had a missing Week 12 PASI score.|||Participants|||Number
1257144|NCT00454584|Secondary|Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12|Number of participants achieving a physician global assessment (PGA) (0-5) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trial of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).|Week 12|Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had a missing PGA score.|||Participants|||Number
1257145|NCT00454584|Primary|Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12|Number of participants achieving greater than or equal to 75 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). Baseline visit refers to Week 0.|Baseline and Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participants is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or has missing data at Week 12.|||Participants|||Number
1257146|NCT00454571|Secondary|Median PSA Progression-free Survival|Kaplan-Meier estimates for PSA progression-free survival will be computed for the pazopanib and active surveillance groups and compared using the log rank test. The outcome measure is median PSA progression-free survival time.|Time from randomization to PSA progression or death from any cause|Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to PSA progression.||||||
1257147|NCT00454571|Primary|Median Time to PSA Progression|The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.|Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment|Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to disease progression.||||||
1257148|NCT00454532|Primary|Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)|Best Overall Tumor Response - Independent Radiology Assessment|2 months||||participants|||Number
1257149|NCT00454532|Primary|Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)|Best Overall Tumor Response - Investigator Assessment|2 Months||||participants|||Number
1257150|NCT00454532|Primary|Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)|Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0|Monthly||||participants|||Number
1257151|NCT00454363|Secondary|Change in Tumor Blood Flow Assessed by Functional CT||Baseline and week 12|||||||
1257152|NCT00454363|Secondary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death.|Baseline to 18 months.|Analysis calculated according to intent to treat.|||months||95% Confidence Interval|Median
1257154|NCT00454363|Primary|Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.|Up to 18 months|RECIST best protocol response by intention to treat. Four participants were not evaluable for response.|||participants|||Number
1257155|NCT00454324|Secondary|Number of Individuals With Adverse Events|Drug toxicities will be evaluated during treatment period and 30 days post treatment. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) criteria. Grade 3 or 4 adverse events were reported|10 weeks||||Participants|||Count of Participants
1257156|NCT00454324|Secondary|Progression Free Survival (PFS)|Defined as the time between trial enrollment to disease progression or death (whichever occurs first) or date of last contact|Through the end of the study, an average of approximately 8 months||||Months||95% Confidence Interval|Median
1257157|NCT00454324|Secondary|1-year Overall Survival (OS)|Percentage of participants from the start of treatment with the disease that are still alive.|every 12 weeks for 1 year||||percentage of participants||95% Confidence Interval|Number
1257158|NCT00454324|Primary|Overall Response Rate|Radiological imaging should be performed every 12 weeks, to ascertain the overall (or objective) response rate (Complete Response or Partial Response) according to the RECIST guidelines. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Overall Response Rate = CR+PR.|12 weeks||||percentage of participants||95% Confidence Interval|Number
1257159|NCT00454246|Secondary|Number of Participants Assessed for AEs and SAEs|The adverse events are captured in the adverse event and serious adverse event section of this database.|First dose of medication through 15 days post last dose (up to 8 months)|Safety Population|||participants|||Number
1257160|NCT00454246|Secondary|Dose Adjustments|Efficacy analyses were not performed.|5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.||||participants|||Number
1257161|NCT00454246|Primary|Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL|Efficacy analyses were not performed.|6-7 months post initiation of dialysis||||percentage of participants|||Number
1257162|NCT00454207|Secondary|Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|The total number of participants with laboratory test abnormalities without regard to baseline abnormality.|Baseline up to 1.3 years|All subjects who received at least one dose of the study medication and had any evaluable laboratory test data after treatment.|||participants|||Number
1257163|NCT00454207|Secondary|The Average Plasma Trough Concentration (Ctrough) of Sildenafil|The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||nanograms/milliliter||Standard Deviation|Mean
1257164|NCT00454207|Secondary|The Average Plasma Concentration (Css,av) of Sildenafil at Steady State|The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||nanograms/milliliter||Standard Deviation|Mean
1257165|NCT00454207|Secondary|The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320|The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||nanogram*hour/milliliter||Standard Deviation|Mean
1257166|NCT00454207|Secondary|Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320|Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||hours||Standard Deviation|Mean
1257167|NCT00454207|Secondary|Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320|Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||nanograms/milliliter||Standard Deviation|Mean
1257168|NCT00454207|Secondary|Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II|Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||picograms/milliliter||Standard Deviation|Mean
1257169|NCT00454207|Secondary|Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||scores on a scale||Standard Deviation|Mean
1257170|NCT00454207|Secondary|Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||participants|||Number
1258270|NCT00445224|Primary|Visual Analog Pain Scale|Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain|8 week||||centimeters||Standard Deviation|Mean
1257171|NCT00454207|Secondary|Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||meters||Standard Deviation|Mean
1257172|NCT00454207|Secondary|Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I|Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline|Baseline, Week 4, Week 8, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).|||picograms/milliliter||Standard Deviation|Mean
1257173|NCT00454207|Secondary|Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I|Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.|Baseline, Week 8, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).|||scores on a scale||Standard Deviation|Mean
1257174|NCT00454207|Secondary|Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I|The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||participants|||Number
1257175|NCT00454207|Secondary|Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257176|NCT00454207|Secondary|Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.|baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257177|NCT00454207|Secondary|Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||percent saturation||Standard Deviation|Mean
1257178|NCT00454207|Secondary|Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||percent saturation||Standard Deviation|Mean
1257179|NCT00454207|Secondary|Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.|baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||dyne*second/centimeter^5/meter^2||Standard Deviation|Mean
1257180|NCT00454207|Secondary|Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||dyne*second/centimeter^5||Standard Deviation|Mean
1257181|NCT00454207|Secondary|Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||dyne*second/centimeter^5/meter^2||Standard Deviation|Mean
1257182|NCT00454207|Secondary|Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Heart rate at Week 12 minus heart rate at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||beats/minute||Standard Deviation|Mean
1257183|NCT00454207|Secondary|Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Cardiac index at Week 12 minus cardiac index at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||liter/minute/meter^2||Standard Deviation|Mean
1257284|NCT00453921|Primary|Neuropsychological Assessment, CVLT-II|Memory measure: California Verbal Learning Test, 2nd edition (CVLT), Total, trials 1-5 (range: 0-80). Higher scores are better outcome.|post-intervention (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
1257184|NCT00454207|Secondary|Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257185|NCT00454207|Secondary|Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257186|NCT00454207|Primary|Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Cardiac output at Week 12 minus cardiac output at baseline|Baseline, week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||liter/minute||Standard Deviation|Mean
1257187|NCT00454207|Secondary|Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|"Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3.~Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline."|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257188|NCT00454207|Secondary|Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257189|NCT00454207|Secondary|Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257190|NCT00454207|Secondary|Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257191|NCT00454207|Secondary|Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257192|NCT00454207|Secondary|Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I|"Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline.~The 6-minute walk distance:Total distance walked during the 6- minute walk test."|Baseline, Week 8|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline.|||meters||Standard Deviation|Mean
1257193|NCT00454207|Primary|Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||dyne·second/centimeter^5||Standard Deviation|Mean
1257194|NCT00454207|Primary|Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
1257195|NCT00454207|Primary|Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||meters||Standard Deviation|Mean
1257196|NCT00454194|Secondary|Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|"A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria."|Up to 5 years|All participants who met the eligibility criteria and started the treatment.|||percentage of participants|||Number
1257197|NCT00454194|Secondary|Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.|Up to 3 years|All participants who met the eligibility criteria and started the treatment.|||participants|||Number
1257198|NCT00454194|Secondary|Duration of Response|"Duration of response was defined as the time from the date at which the patient’s earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;"|Up to 5 years|All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.|||months||95% Confidence Interval|Median
1257199|NCT00454194|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from date of randomization to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or other medical problems.|Up to 5 years|All participants who met the eligibility criteria and ended the treatment.|||months||95% Confidence Interval|Median
1257200|NCT00454194|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.|Time from randomization to death or last follow-up (up to 5 years)|All participants who met the eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
1257201|NCT00454194|Primary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from randomization to the disease progression or death (up to 5 years)|All participants who met the eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
1257202|NCT00454181|Secondary|Investigator Assessment Regarding Global Oral Changes.|"Number of subjects with improvement from baseline to week 24 in global oral health as rated by the attending investigator. Scale was subjective with 3 choices: improved, worsened, or unchanged."|24 weeks, from baseline to the end of treatment||||participants|||Number
1257203|NCT00454181|Secondary|Investigator Assessment Regarding Changes in Warts|"Number of subjects with improvement in oral warts from baseline to week 24 as rated by the attending investigator. Scale was subjective with 3 choices: improved, worsened, or unchanged."|24 weeks, from baseline to the end of treatment||||participants|||Number
1257204|NCT00454181|Secondary|Subject Questionnaire Regarding Global Oral Changes|"Number of subjects reporting change in global oral health from baseline to week 24 as better. Scale was subjective with 3 choices: better, worse, or unchanged."|24 weeks, from baseline to end of treatment||||participants|||Number
1257205|NCT00454181|Secondary|Subject Questionnaire Regarding Changes in Warts|"Number of subjects reporting change in oral warts from baseline to week 24 as better. Scale was subjective with 3 choices: better, worse, or unchanged."|24 weeks, from baseline to the end of treatment||||participants|||Number
1257206|NCT00454181|Secondary|Total Surface Area of the Lips Covered by Warts|Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area|24 weeks, from baseline to the end of treatment|Per protocol - only a sub-set of subjects had lip warts at study entry|||participants|||Number
1257207|NCT00454181|Primary|Change in Total Oral Mucosal Area Covered by Warts.|Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area|24 weeks, from baseline to the end of treatment|Per protocol|||participants|||Number
1257208|NCT00454142|Secondary|Pharmacokinetic Study: Volume of Distribution at Steady State (Vss/F/Dose) on Day 28|Volume of distribution at steady state (Vss/F/Dose) were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.|Day 28 of treatment||||mL/mg||Full Range|Median
1257209|NCT00454142|Secondary|Pharmacokinetic Study: Volume of Distribution (Vd/F/Dose) on Day 1|Volume of distribution (Vd/F/dose) were measured on day 1 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 hrs after first dose.|Day 1 of treatment||||mL/mg||Full Range|Median
1257210|NCT00454142|Secondary|Pharmacokinetic Study: Area Under Curve (AUC) 0-24h/Dose on Day 28|AUC 0-24h/dose were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.|Day 28 of treatment||||hr*ng/mL/mg||Full Range|Median
1257211|NCT00454142|Secondary|Pharmacokinetic Study: AUC0-24h/Dose on Day 1|AUC 0-24h/dose were measured on day 1 for 26 evaluable participants. Blood sampling is done at zero (pre-dose), 0.5 hr, 1, 2, 3, 4, 5, 6 and 8 hrs after the first dose.|Day 1 of treatment||||hr*ng/mL/mg||Full Range|Median
1257212|NCT00454142|Secondary|Pharmacokinetic Study: Percentage of Participants With Trough Concentration at Steady State (Day 28) Above 15 µg/mL|Pazopanib pharmacokinetic parameters were estimated on Day 1 and Day 28 (steady state). Trough concentration of pazopanib was measured on Day 28 with blood sampling at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after Day 28 dose.|Day 28 of treatment|Patients (total 26) with both Day 1 and Day 28 pharmacokinetic parameters were included.The trough concentration of pazopanib on Day 28 was observed to be above 15ug/ml in approximately 92% of patients at steady state.|||percentage of participants|||Number
1257213|NCT00454142|Secondary|Pharmacodynamic Study: Tumor Blood Flow on Day 28|DCE-CT was performed on Day 28 and tumor blood flow was measured. 19 of 33 patients had evaluable DCE-CT data.|28 days post treatment||||ml/100ml/min||Standard Deviation|Mean
1257214|NCT00454142|Secondary|Pharmacodynamic Study: Tumor Blood Flow at Baseline|Dynamic-contrast enhanced computed tomography (DCE-CT) was performed at baseline and Day 28, tumor blood flow was measured.19 of 33 patients had evaluable DCE-CT data.|Pretreatment||||ml/100ml/min||Standard Deviation|Mean
1257215|NCT00454142|Secondary|Toxicity Profile: Percentage of Participants With Significant (Grade 3/4) Related Adverse Event (AE)|The frequencies of grade 3/4 related toxicities were recorded among all participants, and the percentage of participants who experienced significant AEs were reported.|From the time of first treatment with pazopanib hydrochloride to up to 30days after completion of treatment||||percentage of participants|||Number
1257216|NCT00454142|Secondary|Overall Survival||From date of enrollment to the study to the date of death from any cause or to the date when the patient was last known to be alive, up to 3 years.||||months||95% Confidence Interval|Median
1257217|NCT00454142|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST ver 1.0) and assessed by CT or MRI. CBR includes 1) Complete response (CR): disappearance of all lesions; 2) partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions and 3) stable disease (SD): non-PR and non progressive disease.|12 weeks of treatment||||percentage of participants||95% Confidence Interval|Number
1257218|NCT00454142|Secondary|Progression-free Survival|Progression will be evaluated in this study using the new international criteria proposed by RECIST Committee. The sample proportion and associated 95% confidence interval will be reported.|From the date of enrollment to the date of first documented progression or death, whichever occurs first, or to the date when the patient was last known to be alive, up to 3 years.||||months||95% Confidence Interval|Median
1257219|NCT00454142|Secondary|Response Rate (PR)|Per response evaluation criteria in solid tumors (RECIST v1.0) and assessed by MRI or CT: Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-PD (PD: progressive disease) of non-target lesions.|12 weeks of treatment||||percentage of participants|||Number
1257220|NCT00454116|Primary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|Tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (28 March 2008 +/-3 days)||||Participants|||Number
1257221|NCT00454051|Secondary|Physician's Overall Assessment of Treatment Effectiveness|The Physician's overall assessment of treatment effectiveness was graded 1-5 as 1 = Excellent asthma control (complete control) 2 = Good asthma control (marked improvement) 3 = Moderate asthma control (discernible, but limited improvement) 4 = Poor asthma control (no appreciable change) 5 = Very poor asthma control (worsening)|After 16 weeks of treatment|The ITT population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. Complete data for 26 of the total 30 participants was recorded.|||participants|||Number
1257222|NCT00454051|Secondary|Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)|Peak Expiratory Flow (PEF) was measured every morning using a peak flow meter, and was recorded in the patient diary. For this analysis, the mean morning PEF during the 4-week screening period prior to randomizaton is compared with the mean morning PEF during the last 4 weeks of study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||liters per minute||Standard Deviation|Mean
1257223|NCT00454051|Secondary|Change From Baseline in the Number of Unscheduled Clinic Visits|Participants maintained a diary to record the number of unscheduled clinic visits during the study. For this analysis, the number of unscheduled visits during the 4 week screening period prior to randomization is compared with the number of unscheduled visits during the last 4 weeks on treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||unscheduled visits||Standard Deviation|Mean
1257224|NCT00454051|Secondary|Change From Baseline in the Number of Days With Hospitalizations|Participants maintained a diary to record the number of days with hospitalizations during the study. For this analysis, the number of days with hospitalizations during the screening period (4 weeks prior to randomization) was compared with the number of days with hospitalizations during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||days||Standard Deviation|Mean
1257225|NCT00454051|Secondary|Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms|Participants maintained a diary to record the number of days with absence from school or work due to asthma symptoms. For this analysis, the number of days with absence from school or work in the four weeks prior to randomization (screening period) were compared with the number of absence days during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||days||Standard Deviation|Mean
1257226|NCT00454051|Secondary|Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week|"Impairment was defined as days with physical activity considered as limited (or not normal) according to patient's assessment and was recorded in a patient daily diary. For this analysis, the mean number of days with impairment per week during the 4 week screening period prior to randomization was compared with the mean number of days with impairment per week during the last 4 weeks on study treatment (Weeks 12 - 16)."|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||days per week||Standard Deviation|Mean
1257227|NCT00454051|Secondary|Change From Baseline in the Number of Nights With Awakenings Per Week|Participants maintained a diary to record the number of nights with awakenings due to asthma symptoms per week. For this analysis, the mean number of nights with awakenings per week during the 4 week screening period prior to randomization was compared with the mean number of nights with awakenings per week during the last 4 weeks of study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||nights with awakenings per week||Standard Deviation|Mean
1257285|NCT00453479|Secondary|Derived Urine PK Parameters-area Under Concentration-renal Clearance (Clr)|Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study. 12 hour pharmacokinetic sampling was before evening dose.|Day 1 and 7 throughout 24 hours|PK population was used. Only those participants available at the specified time points were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
1257228|NCT00454051|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Week|Participants maintained a diary to record the daytime number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms per week. This analysis compares the mean number of puffs of rescue medication per week during the 4 week screening period prior to randomization to the mean number of puffs per week during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||puffs per week||Standard Deviation|Mean
1257229|NCT00454051|Primary|Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo|Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.|Baseline and Week 16|The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.|||percent change in fluorescence intensity||Standard Deviation|Mean
1257230|NCT00454051|Secondary|Change From Baseline in the Number of Days With Asthma Symptoms Per Week|Participants maintained a diary to record the number of days with daytime asthma symptoms per week. This analysis compares the mean number of days per week with asthma symptoms during the 4-week screening period prior to randomization with the mean number of days per wek with asthma symptoms in the last 4 weeks of study treatment (Weeks 12 -16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||days per week||Standard Deviation|Mean
1257231|NCT00454051|Secondary|Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment|Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.|Baseline, Weeks 4, 8, 12, and 16|A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.|||% change in fluorescence intensity||Standard Deviation|Mean
1257232|NCT00454051|Secondary|Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment|Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.|Baseline, Weeks 4, 8, 12 and 16|A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.|||percent change in cells expressing FcεRI||Standard Deviation|Mean
1257233|NCT00454051|Primary|Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo|Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.|Baseline and Week 16|The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.|||percent change in FcεRI expression||Standard Deviation|Mean
1257234|NCT00453999|Secondary|Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)|Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group.|Baseline, and 12, 24, 36, 48, 72, and 96 hours|Among the 122 subjects with confirmed influenza (intent-to-treat infected [ITTI]) population, a total of 112 subjects had positive virus cultures obtained from baseline nasopharyngeal specimens.|||log10 TCID50/mL||Standard Deviation|Mean
1257235|NCT00453999|Secondary|Time to Hospital Discharge (Kaplan-Meier Estimate)|Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment.|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||hours||95% Confidence Interval|Median
1257236|NCT00453999|Secondary|Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)|The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group.|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||participants|||Number
1257935|NCT00447499|Secondary|Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients|Blood samples taken before and 60 and 120 min after glucose load from fasting patient.|24 Weeks|Patients switched directly from octreotide who had GH level measured at the end of study.|||ng/mL||Standard Deviation|Mean
1257237|NCT00453999|Secondary|Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)|Changes in each subject’s ability to perform usual activities as determined from the visual analog scale (0 to 10, where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully) were summarized by study visit and treatment group. The time to resumption of a subject’s ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data).|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||hours||95% Confidence Interval|Median
1257238|NCT00453999|Secondary|Change From Baseline in Scores of Symptoms of Influenza|Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue, each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]) were tabulated by treatment group. Missing data were excluded.|Baseline, Days 2, 3, 4, 5, 10, and 14|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||units on a scale||Standard Deviation|Mean
1257239|NCT00453999|Primary|Time to Clinical Stability (Kaplan-Meier Estimate)|Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||hours||95% Confidence Interval|Median
1257240|NCT00453986|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257241|NCT00453986|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort|An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257242|NCT00453986|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257243|NCT00453986|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257244|NCT00453986|Secondary|Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort|AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257245|NCT00453986|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort|NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257246|NCT00453986|Secondary|Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort|Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257247|NCT00453986|Secondary|Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257248|NCT00453986|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257249|NCT00453986|Secondary|Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257250|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort|Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = > 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257251|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature > 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257252|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration.|During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administration|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257253|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|During the 4-day (Days 0-3) follow-up period after meningococcal vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257254|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1257286|NCT00453479|Secondary|Derived Urine PK Parameters-area Under Concentration-fraction of Dose Excreted Unchanged in Urine (Fe)|Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data presented as 0-12 hours and 12-24 hours. 12 hour pharmacokinetic sampling was before evening dose.|Day 1 and 7 throughout 24 hours|PK population was used.|||Percentage of dose||Standard Deviation|Mean
1258271|NCT00445224|Secondary|Hip Abduction Strength|Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer|8 week||||(Newton*meters)/(Weight*Height)||Standard Deviation|Mean
1257255|NCT00453986|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort|Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1257256|NCT00453986|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort|Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257257|NCT00453986|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1257258|NCT00453986|Secondary|Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 & PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257259|NCT00453986|Secondary|Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort|Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1257260|NCT00453986|Secondary|Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort|Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257261|NCT00453986|Secondary|Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1257262|NCT00453986|Secondary|Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257287|NCT00453479|Secondary|Derived Urine Pharmacokinetic (PK) Parameters-area Under the Plasma Concentration-amount of Drug Excreted Unchanged in Urine (Ae)|Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data presented as AM dose and PM dose. 12 hour pharmacokinetic sampling was before evening dose.|Day 1 and 7 throughout 24 hours|PK population was used.|||Nanogram||Geometric Coefficient of Variation|Geometric Mean
1258272|NCT00445224|Secondary|Objective Function by Step-down Task for 30 Seconds||Baseline, Mid, and Post-Intervention|||||||
1257263|NCT00453986|Secondary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort|Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer >1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257264|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1257265|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257266|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1257267|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257268|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|Prior to vaccination (at Month 0).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1257269|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257270|NCT00453986|Primary|Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|Prior to and one month after vaccination (at Month 0 and Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257271|NCT00453986|Primary|Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Fold increase in serum HI GMTs||95% Confidence Interval|Mean
1257272|NCT00453986|Primary|Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|"Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer >1:40, or a pre-vaccination titer >1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain.~Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B."|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257273|NCT00453986|Primary|Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1257274|NCT00453986|Primary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1257275|NCT00453986|Primary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
1257276|NCT00453986|Primary|Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1257277|NCT00453973|Primary|Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Final Dosing Guideline Change||Up to 54 months|Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change|||percentage of participants|||Number
1257278|NCT00453921|Secondary|Self Report Questionnaire - MASQ|The Multiple Abilities Questionnaire (self rating) is a questionnaire in which participants can identify deficits/complaints in the areas of language, visual perception, verbal memory, visual memory and attention and concentration. A total score is calculated; range is 30-130. Higher scores indicate greater level of complaints (worse outcome). For the purposes of this study, a score one standard deviation above the mean (102.7) indicated significant reported cognitive complaints.|post-intervention (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
1257279|NCT00453921|Primary|Change in Right Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention|Change from pre- to post-treatment in brain activation in the right inferior frontal region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.|pre- to post-treatment (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
1257280|NCT00453921|Primary|Change in Left Middle/Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention|Change from pre- to post-treatment in brain activation in the left middle/inferior frontal region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.|pre- to post-treatment (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
1257281|NCT00453921|Primary|Change in Anterior Cingulate Gyrus Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention|Change from pre- to post-treatment in brain activation in the anterior cingulate region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.|pre- to post-intervention (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
1257282|NCT00453921|Primary|Functional MRI Task Performance and Brain Activation (Change From Baseline to Post-treatment)|Change in performance (percent correct,adjusted for guessing) from pre-(baseline) to post-treatment (approximately 7 weeks) for in-scanner n-back working memory task (Range: 0-100). Higher scores means better performance.|pre- to post-6 week treatment intervention (at least 7 weeks)||||percentage of correct targets (adjusted)||Standard Deviation|Mean
1257288|NCT00453479|Secondary|Derived PK Plasma Parameters-area Under Concentration-time of Maximum Observed Plasma Concentration (T-max), Half-life (T-half) and Last Time Point Where the Concentration is Above the Limit of Quantification (T-last)|Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning and evening samples.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used.|||Hour||Full Range|Median
1257289|NCT00453479|Secondary|Derived PK Plasma Parameters-area Under Concentration-maximum Observed Plasma Concentration (Cmax)|Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning and evening samples as adjusted geometric mean.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used.|||Nanograms per liter||90% Confidence Interval|Geometric Mean
1257290|NCT00453479|Secondary|Derived Plasma PK Parameters-area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)|Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning sample as adjusted geometric mean.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used.|||Hour×Nanograms per milliliter||90% Confidence Interval|Geometric Mean
1257291|NCT00453479|Secondary|Derived Plasma PK Parameters-area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau)|Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning samples.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used.|||Hour×Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1257292|NCT00453479|Secondary|Urine Concentrations of GSK233705|Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data is presented as 0-12 hours and 12-24 hours. 12 hour pharmacokinetic sampling was before evening dose.|Day 1 and 7 throughout 24 hours|PK population was used.|||Nanograms per liter||Standard Deviation|Mean
1257293|NCT00453479|Secondary|Plasma Concentrations of GSK233705|Blood samples were collected at indicated time points. 12 hour pharmacokinetic (PK) sampling was before evening dose.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used; this was defined as all participants in the all subjects population for whom a PK sample was obtained and analyzed.|||Nanograms per milliliter||Standard Deviation|Mean
1257294|NCT00453479|Primary|Summary of Mean (0–24 Hour) and Maximum (0–24 Hour) Heart Rate Measured Using 24 Hour Using Holter ECG Data|Holter monitors were switched on immediately prior to dosing (up to 15mins pre-dose) so as to capture Holter ECG data from the 24 hour period following dosing. It was assessed on Day 1 and 7.|Up to Day 7|All subject population was used.|||Beats per minute||95% Confidence Interval|Least Squares Mean
1257295|NCT00453479|Primary|Summary of Microscopy Data for Participants With Abnormal Urinalysis Dipstick Results|Urinalysis parameters included protein, blood, ketones, glucose, bilirubin, urobilinogen, leukocyte esterase, specific gravity, nitrites and pH. Sediment microscopy was performed only on urine samples showing an abnormality on the dipstick. Microscopy was performed for: WBC, RBC, hyaline casts, granular casts and cellular casts. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours).|Up to Day 7 (pre dose)|All subject population was used.|||Participants|||Count of Participants
1257296|NCT00453479|Primary|Number of Participants With Abnormalities in Hematology Data of Clinical Concern|Hematology parameters included platelet count, red blood cell (RBC) count, mean corpuscular volume (MCV), total neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours). Data for parameters with above and below the PCI is provided.|Up to Day 7|All subject population was used.|||Participants|||Count of Participants
1257297|NCT00453479|Primary|Number of Participants With Abnormalities in Chemistry Data of Clinical Concern|Clinical chemistry parameters included urea, potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, creatine kinase, chloride, alanine aminotransferase (ALT), uric acid, glucose, gamma glutamyltransferase (GGT), albumin, sodium, phosphorus inorganic, calcium, alkaline phosphatase (ALP) and total protein. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours). Data for parameters with above and below the potential clinical concern (PCI) is provided.|Up to Day 7|All subject population was used.|||Participants|||Count of Participants
1257298|NCT00453479|Primary|Number of Participants Who Used Rescue Medication|Inhaled salbutamol was used as a rescue medication. Participants were required to keep a diary of their rescue medication (total number of salbutamol doses taken) over the entire 7-day treatment period. Diaries were reviewed by the Investigator when participants were admitted to the unit on Days 1, 2, 7 and 8.|Up to Day 7|All subject population was used.|||Participants|||Count of Participants
1257299|NCT00453479|Primary|Summary of Mean Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)|It was assessed on 1, 2, 4, 9, 12 and 24 hours on Days 1 and 7. Also on Day 7, it was measured on 0 hour (Baseline). At all time points 3 measurements were taken and formal statistical analysis was carried out on the derived maximum readings. Data for adjusted mean is presented as least square mean.|Up to Day 7 (24-hour post dose)|All subject population was used.|||Liters||95% Confidence Interval|Least Squares Mean
1257300|NCT00453479|Primary|Weighted Mean (0–4 h) for the Morning Dose of ECG Parameters QTcF and QTc B|Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Milliseconds||95% Confidence Interval|Least Squares Mean
1257301|NCT00453479|Primary|Maximum Value (0–4 Hour) for the Morning Dose of ECG Parameters Corrected According to Fredericia’s Formula (QTcF) and Corrected According to Bazett’s Formula (QTc B)|Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Milliseconds||95% Confidence Interval|Least Squares Mean
1257302|NCT00453479|Primary|Number of Participants With Abnormal 12-lead ECG Findings|Single measurements were taken at all time points. The pre-dose values were classed as Baseline. Data for number of participants with normal, abnormal not clinically significant and abnormal clinically significant is presented. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7.|Up to Day 7 (24 hour post dose)|All subject population was used. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1257303|NCT00453479|Primary|Weighted Mean of Heart Rate (0-4 Hour) for the Morning Dose|Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Beats per minute||95% Confidence Interval|Least Squares Mean
1257304|NCT00453479|Primary|Weighted Mean of SBP and DBP (0-4 Hour) for the Morning Dose|Blood pressure was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Millimeters of mercury||95% Confidence Interval|Least Squares Mean
1257305|NCT00453479|Primary|Maximum Value of Heart Rate (0-4 Hour) for the Morning Dose|Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Beats per minute||95% Confidence Interval|Least Squares Mean
1257306|NCT00453479|Primary|Maximum Value of SBP and DBP (0-4 Hour) for the Morning Dose|Blood pressure was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population|||Millimeters of mercury||95% Confidence Interval|Least Squares Mean
1257307|NCT00453479|Primary|Summary of Mean Heart Rate|Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7.|Up to Day 7 (24 hour post dose)|All subject population was used.|||Beats per minute||Standard Deviation|Mean
1257308|NCT00453479|Primary|Summary of Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured subsequent to 12 lead electrocardiogram (ECG). Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7.|Up to Day 7 (24 hours post-dose)|All subject population was used.|||Millimeters of mercury||Standard Deviation|Mean
1257309|NCT00453479|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to follow-up (approximately 45 days)|All subject population included all available data on participants who had received at least one dose of study medication (including placebo).|||Participants|||Count of Participants
1257310|NCT00453388|Secondary|Incidence of Adverse Events|Number of subjects who developed reportable AEs, assessed using adapted version of the Common Toxicity Criteria|Up to 6 years||||Participants|||Count of Participants
1257311|NCT00453388|Secondary|Incidence of Transplant-related Mortality|Number of subjects who expired due to transplant-related mortality|Up to Day 200||||Participants|||Count of Participants
1257312|NCT00453388|Primary|Incidence of Grades III-IV Acute GVHD|"Number of subjects who developed maximum grade acute graft-vs-host disease~aGVHD Stages~Skin:~- a maculopapular eruption involving < 25% BSA~- a maculopapular eruption involving 25 - 50% BSA~- generalized erythroderma~- generalized erythroderma with bullous formation and often with desquamation~Liver:~- bilirubin 2.0 - 3.0 mg/100 mL~- bilirubin 3 - 5.9 mg/100 mL~- bilirubin 6 - 14.9 mg/100 mL~- bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Up to Day 100||||Participants|||Count of Participants
1257313|NCT00453388|Primary|Number of Patients Who Engraft at Each Dose of TBI Used|Number of subjects who engrafted. Engraftment defined as greater than 95% donor chimerism.|Up to Day 200||||Participants|||Count of Participants
1257314|NCT00453362|Secondary|Number of Participants With Adverse Events Due to FLT-PET Imaging|The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.|From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.|Patients with non−small cell lung cancer (NSCLC) who underwent FLT-PET scans.|||Participants|||Number
1257323|NCT00453362|Secondary|Percentage of Patients With FLT-PET Responses|"In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|Day 14 and Day 56|FLT−Evaluable Patients. Participants who were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1257315|NCT00453362|Primary|Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans of <−25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|From first erlotinib treatment to death, assessed up to 2 years|"Patients who were treated with erlotinib,underwent all FLT-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.~CT SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|||months||Full Range|Median
1257316|NCT00453362|Primary|Overall Survival of Groups by FLT Response at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%."|From first erlotinib treatment to death, assessed up to 2 years|FLT−Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.|||months||Full Range|Median
1257317|NCT00453362|Primary|Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|From first erlotinib treatment to death, assessed up to 2 years|"Patients who were treated with erlotinib, underwent all FDG-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."|||months||Full Range|Median
1257318|NCT00453362|Secondary|FLT Response in Subgroups by CT Response at Day 56|"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <−25%.~CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.~CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions."|Day 56|FLT−Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1257319|NCT00453362|Secondary|FDG Response in Subgroups by CT Response at Day 56|"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <−25%.~CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.~CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions."|Day 56|FDG−Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1257320|NCT00453362|Primary|Overall Survival of Groups by FDG Response at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25%."|From first erlotinib treatment to death, assessed up to 2 years|FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.|||months||Full Range|Median
1257321|NCT00453362|Primary|Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|"FLT-Evaluable patients were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."|||weeks||Full Range|Median
1257322|NCT00453362|Primary|Progression Free Survival of Groups by FLT Response at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.|||weeks||Full Range|Median
1257324|NCT00453362|Primary|PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <−25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|"FDG-Evaluable patients were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."|||weeks||Full Range|Median
1257325|NCT00453362|Secondary|Percentage of Patients With FDG-PET Responses|"In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment.~FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25%.~CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|Day 14 and Day 56|FDG-Evaluable patients. Participants who were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1257326|NCT00453362|Primary|Progression Free Survival (PFS) of Groups by FDG Response at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.|||weeks||Full Range|Median
1257327|NCT00453349|Secondary|Number of Subjects Who Received Alternative Medicine|As alternative medicine any systemic antibacterial medication was considered.|Up to 42 days after end of treatment|The number of subjects who received alternative medicine in the PP population was analyzed. The clinical response was graded as alternative medicine (clinical cure, improvement, continued clinical cure) versus no alternative medicine.|||participants|||Number
1257328|NCT00453349|Secondary|Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism|Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.|28 - 42 days after completion of study drug therapy|At the follow-up visit, the bacteriological success response was classified as Eradication, and recurrence/persistence as bacteriological failures.|||participants|||Number
1257329|NCT00453349|Secondary|Bacteriological Response at Follow-up Visit Microbiologically Valid|Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.|28 - 42 days after completion of study drug therapy|At the follow-up visit, the bacteriological success response was classified as eradication, and recurrence/persistence as bacteriological failures.|||participants|||Number
1257330|NCT00453349|Secondary|Clinical Response at Follow-up Visit on Intent To Treat Population|"All successfully treated subjects and subjects evaluated asindeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes."|28 - 42 days after completion of study drug therapy|At the follow-up visit, the clinical response in subjects who were non-failures at the TOC visit were graded as Continued cure, Clinical relapse or Indeterminate.|||participants|||Number
1257331|NCT00453349|Secondary|Clinical Response at Follow-up Visit on Per Protocol Population|Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.|28 - 42 days after completion of study drug therapy|"All successfully treated subjects and subjects evaluated as indeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow up visit. Patients with missing or indeterminate outcome were omitted."|||participants|||Number
1257332|NCT00453349|Secondary|Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism|Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.|7 - 14 days at TOC visit|Patients were included in this analysis if a causative organism could be established pre-therapy by culture or PCR, and if the patient was valid for intent-to-treat.|||participants|||Number
1257352|NCT00453180|Secondary|Social Responsiveness Scale|The Social Responsiveness Scale (SRS) is a 65-item scale that assesses social impairment in the aspects of social awareness, social cognition, social communication, social motivation and autistic mannerisms. Each item is scored from 0 (not true) to 3 (almost always true). The total SRS raw score may range from 0-195, where higher scores indicate greater severity.|Week 12||||units on a scale||Standard Deviation|Mean
1257333|NCT00453349|Secondary|Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid|The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.|7 - 14 days at TOC visit|All subjects for whom a specific bacterial pathogen was isolated/identified from any pre-treatment culture and which was considered responsible for the infection would be assessed for bacteriological efficacy.|||participants|||Number
1257334|NCT00453349|Secondary|Clinical Response on Treatment for Intent To Treat Population|Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.|4 - 7 days after start of therapy|Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis. For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis.|||participants|||Number
1257335|NCT00453349|Secondary|Clinical Response on Treatment for Per Protocol Population|At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by >30% with improvement in temperature, clinical failure (reduction in severity score of < or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).|4 - 7 days after start of therapy|Analysis was performed for the per protocol population.|||participants|||Number
1257336|NCT00453349|Secondary|Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population|"For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to non-success."|7 - 14 days after completion of study drug therapy|Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis.|||participants|||Number
1257337|NCT00453349|Primary|Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population|Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by > 70% and apyrexia (rectal/tympanic/oral temperature value < 38.0°C or axillary temperature value < 37.5°C) and white blood cell count < 10,500/mm^3.|7 - 14 days after completion of study drug therapy|The number of subjects in the PP population was slightly higher than the planned number of subjects (184 subjects per treatment group). The most common reasons for exclusion from the population valid for efficacy in both the Moxifloxacin and Comparator were essential data missing/invalid, followed by violation of inclusion/exclusion criteria.|||participants|||Number
1257338|NCT00453336|Primary|Number of Participants Experiencing Adverse Events|Number of participants enrolled experiencing serious adverse events and/or other non-serious events|6 months||||participants|||Number
1257339|NCT00453336|Primary|Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment|Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.|6 months||||participants|||Number
1257340|NCT00453310|Primary|Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment||2 years||||participants|||Number
1257341|NCT00453206|Secondary|Treatment-related Mortality at 100 Days After Transplantation||100 days|||||||
1257342|NCT00453206|Secondary|Quality of Life at the Time of Transplantation||baseline|||||||
1257343|NCT00453206|Secondary|Iron Status at the Time of Transplantation||baseline|||||||
1257344|NCT00453206|Secondary|Graft-versus-host Disease||monthly|||||||
1257345|NCT00453206|Secondary|Disease-free Survival||monthly|||||||
1257346|NCT00453206|Secondary|Overall Survival||monthly|||||||
1257347|NCT00453206|Secondary|Complete Response||monthly|||||||
1257348|NCT00453206|Primary|Treatment-related Mortality Within the First 6 Months After Transplantation||6 months||||participants|||Number
1257349|NCT00453193|Primary|Number of Participants With Objective Response|Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.|After a maximum of 6 months of therapy maintained for one month.|Analysis was per protocol.|||Participants|||Number
1257350|NCT00453180|Secondary|Vineland Adaptive Behavior Scales-II (VABS-II)|The VABS-II is a semi-structured interview designed to assess adaptive functioning in the domains of communication, daily living skills and socialization. Items in each domain are rated as either 0 (does not), 1(sometimes) or 2(independently) performs a given behavior or skill. The communication domain has 99 items with scores ranging from 0-198. The daily living skills domain has 109 items with scores ranging from 0-218. The socialization domain has 99 items with scores ranging from 0-198. The domains scores are combined to form the adaptive composite score (ranging from 20-160). The raw scores from the communication, daily living skills and socialization domains along with the composite score were selected for use in this study. Higher scores indicate a higher level of adaptive functioning.|Week 12||||units on a scale||Standard Deviation|Mean
1257351|NCT00453180|Secondary|Pervasive Developmental Disorder Behavior Index|The PDD Behavior Inventory (PDDBI) is a rating scale filled out by caregivers or teachers that was designed to assess children having a Pervasive Developmental Disorder (PDD; autism, Asperger disorder, PDD-NOS, or childhood disintegrative disorder). Both adaptive and maladaptive behaviors are assessed in the scale, making it useful for treatment studies in which decreases in maladaptive behaviors and improvements in adaptive social and language skills relevant to PDD are expected.|Week 12|Less than 25% of participants in each group received a score on the PDDBI due to a significant floor effect. As a result, the data for these participants are not considered reliable given the significant floor effect.||||||
1257353|NCT00453180|Secondary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each of the 58 items are rated from 0 (not at all) to 3 (severe).The ABC has 5 subscales: Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Lethargy (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe). Higher scores indicate a higher level of maladaptive behavior.|Week 12||||units on a scale||Standard Deviation|Mean
1257354|NCT00453180|Primary|Clinical Global Impression - Improvement|"Clinical Global Impression - Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment.~The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved, 3=minimally Improved, 4=no change, 5=minimally worse, 6= much worse and 7=very much worse). Participants with a CGI-I score of 1 or 2 were classified as improved. Participants with a CGI score of 3, 4 or 5 were classified as no response. No participants scored 6 or 7."|Week 12||||Participants|||Count of Participants
1257355|NCT00453180|Primary|Clinical Global Impression - Severity|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Week 12||||Participants|||Count of Participants
1257356|NCT00453154|Other Pre-specified|Change in Plasma Levels of PDGF|Correlated with clinical outcome (response and survival).|Baseline to within 7 days of sunitinib/placebo therapy discontinuation|||||||
1257357|NCT00453154|Other Pre-specified|Change in Plasma Levels of VEGF Prior to, During Single-agent, and Following Treatment With Sunitinib Malate|The frequency of tumor response by the optimally dichotomized VEGF levels will be tabulated and their association will be tested by Fisher’s exact test as well as the maximally selected rank test. The association of the VEGF levels as continuous predictor with tumor response will be tested by Wilcoxon rank sum test. Further assessments of the association of the VEGF levels as > continuous or binary variables and the tumor response will be implemented in a logistic regression while adjusting for other covariates such as performance status, weight loss and age|Baseline to within 7 days of sunitinib/placebo therapy discontinuation|||||||
1257358|NCT00453154|Secondary|Number of Participants With Overall Tumor Response|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs.|Up to 3 years|Participants who were randomized to maintenance were analyzed.|||participants|||Number
1257359|NCT00453154|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 3 years|Participants who were randomized to maintenance were analyzed.|||months||95% Confidence Interval|Median
1257360|NCT00453154|Primary|Progression-free Survival (Phase II)|Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Up to 3 years|Participants who were randomized to maintenance were analyzed.|||months||95% Confidence Interval|Median
1257361|NCT00453154|Primary|Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)|The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy).|21 days|Due to safety concerns, the study committee discontinued sunitinib from combination chemotherapy to study single agent sunitinib in the maintenance setting.|||mg/day|||Number
1257362|NCT00453102|Secondary|Number of Participants With Unacceptable Toxicity.|Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.|Up to 12 weeks post-therapy||||participants|||Number
1257363|NCT00453102|Secondary|5 Year Rate of Overall Survival (5-Year OS)|Percentage of participants still alive five years after the date of protocol therapy initiation.|5 Years||||percentage of participants||90% Confidence Interval|Number
1257364|NCT00453102|Secondary|Overall Survival (OS) Rate|The time from the date of initiation of study treatment until date of death from any cause for all participants.|End of Study|Median overall survival by Kaplan-Meier method for all patients was not attained.|||months|||Number
1257365|NCT00453102|Secondary|5-Year Rate of Progression-Free Survival (5-Year PFS)|Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.|5 Years||||percentage of participants||90% Confidence Interval|Number
1257366|NCT00453102|Secondary|Rate of Progression-Free Survival|The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.|End of study.||||months||Full Range|Median
1257367|NCT00453102|Primary|Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.|The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.|12 weeks post-therapy||||percentage of participants||90% Confidence Interval|Number
1257425|NCT00452400|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1257368|NCT00453063|Secondary|Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15|Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||liters/minute||Standard Deviation|Least Squares Mean
1257369|NCT00453063|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)|The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.|Baseline and 15 days|The RQLQ tool is only validated in participants greater than or equal to 18 years of age, so it was only administered in this age group.|||units on a scale||Standard Deviation|Least Squares Mean
1257370|NCT00453063|Secondary|Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15|Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||units on a scale||Standard Deviation|Least Squares Mean
1257371|NCT00453063|Primary|Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15|TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||units on a scale||Standard Deviation|Least Squares Mean
1257372|NCT00453063|Primary|Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15|TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||units on a scale||Standard Deviation|Least Squares Mean
1257373|NCT00452868|Primary|Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks|Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.|24 weeks||||units on a scale||Standard Deviation|Mean
1257374|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the toddler dose(12 months of age)|Safety population: all participants who received toddler dose vaccination (12 months of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
1257375|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 3 of the infant series (14 weeks of age)|Safety population: all participants who received dose 3 of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
1257376|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 2 of the infant series (10 weeks of age)|Safety population: all participants who received dose 2 of the infant series vaccination (10 weeks of age); n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
1257377|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 1 of the infant series (6 weeks of age)|Safety population: all participants who received at least dose 1 of the infant series vaccination (after 6 weeks. n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
1257460|NCT00452361|Secondary|Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52||Weeks 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257378|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (12 months of age)|Safety population: all participants who received toddler dose vaccination(after 12 months). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
1257379|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)|Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 3 of the infant series (14 weeks of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
1257380|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 2 of the infant series (10 weeks of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (10 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
1257381|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 1 of the infant series (6 weeks of age)|Safety population: all participants who received dose 1 of the infant series vaccination (6 weeks of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
1257382|NCT00452790|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.|1 month after toddler dose (13 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1257383|NCT00452790|Secondary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.|||Percentage of participants||95% Confidence Interval|Number
1257384|NCT00452790|Primary|Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.|1 month after the infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1257385|NCT00452790|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.|1 month after the 3-dose infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1257409|NCT00452452|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine.|||percentage of participants|||Number
1257386|NCT00452790|Primary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.|1 month after the infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.|||Percentage of participants||95% Confidence Interval|Number
1257387|NCT00452699|Secondary|Rate of Asthma Attacks Per Participant Per Year|The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a 20% decrease in AM PEF, a 70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.|Week 1 through Week 52|ITT Population|||attacks per participant per year||95% Confidence Interval|Mean
1257388|NCT00452699|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52|A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population for which at least 1 week of diary data were provided|||Percentage of symptom-free days||Standard Error|Mean
1257389|NCT00452699|Secondary|Mean Change From Baseline in AM PEF Over Weeks 1-52|Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population who had a minimum of 1 week PEF values|||Liters/minute (L/min)||Standard Error|Mean
1257390|NCT00452699|Primary|Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52|Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Intent-to-Treat (ITT) Population: all participants randomized to study drug|||Liters||Standard Error|Mean
1257391|NCT00452673|Secondary|Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population|CTC, Version 3 used to assess parameters. (ULN)=upper limit of normal: (ALT)= alanine transaminase; (AST)=aspartate aminotransferase; (ALP)=alkaline phosphatase. ALT Grade (Gr)1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10.0*ULN; Gr 4: >10.0*ULN. ALP (U/L) Gr1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Gr 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Gr 3: < 2 g/dL to <2 g/L. Participants with a baseline chemistry lab value of Gr 0 but who had Gr 3 - 4 chemistry value while on-study are presented below.|Day 1 to 30 days post last dose|Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively.|||participants|||Number
1257392|NCT00452673|Secondary|Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population|National Cancer Institute Common terminology criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN). CTC criteria: Absolute neutrophil count (ANC). Leukocytes (White blood cells) Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Participants with a baseline hematology lab value of Gr 0 but who had Gr 3 - 4 hematology value while on-study are presented below.|Day 1 up to 30 days post last dose|Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively.|||participants|||Number
1257393|NCT00452673|Secondary|Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population|Objective response rate was the percentage of participants, (n/N; number with objective response per Number evaluated) whose best response is either a Complete Response (CR) or a Partial Response (PR). Disease control rate was defined as percentage (n/N) of participants with stable disease greater than (>) 6 months, PR, or CR. Efficacy Evaluable Population: All participants with at least one measurable lesion at baseline, who received at least one dose of combination study drug and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stop treatment prior to tumor assessment for reasons unrelated to disease or drug were excluded.|Day 1 up to 30 days post last dose|n=number of participants with ORR: 2, 1, 0, 6 in dosing arms 1, 2, 3, and 4, respectively. n= number of participants with Disease control: 3, 2, 2, 14 in dosing arms 1, 2, 3, and 4, respectively.|||percentage of participants||95% Confidence Interval|Number
1257408|NCT00452452|Primary|Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1257394|NCT00452673|Secondary|Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population|Complete Response (CR): disappearance of all target and non-target lesions, with confirmation at >=4 weeks interval; Partial Response (PR): >= 30% decrease in sum of longest diameter (LDs) of target lesions, taking as reference the baseline sum LD, with confirmation at >= 4 weeks interval. Progressive Disease (PD): Appearance of new lesion(s), or >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, without unequivocal progression of non-target lesions, after >=6 weeks on study. Radiological tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) occurred every 6 weeks. For those patients who were on treatment > 24 weeks, the tumor assessment occurred every 9 weeks.|Day 1 to 30 days post last dose|All participants with at least one measurable lesion at baseline, who received at least one dose of the combination therapy and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stopped drug prior to tumor assessment for reasons unrelated to disease or drug were excluded.|||participants|||Number
1257395|NCT00452673|Secondary|Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population|Adverse events (AEs) were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious AE (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Day 1 up to 30 days post last dose|Safety Population: all participants receiving at least one dose of study drug.|||participants|||Number
1257396|NCT00452673|Primary|Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population|Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade >= 3, or of Grade 2 which required interruption of treatment for >= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade >= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.|Day 1 to 30 days post last dose|Safety Population: All participants who received at least one dose of study drug. DLTs: Grade 3 headache, Grade 3 pneumonia, Grade 3 diarrhea in Dosing arms, 1, 2, and 3, respectively. DLTs in dose arm 4: 1 participant with Grade 3 pneumonia and pain and 1 participant with Grade 4 neutropenia and diarrhea plus Grade 3 vomiting and mucositis.|||participants|||Number
1257397|NCT00452543|Primary|Total Drinks Consumed Per Drinking Day on the TLFB|Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)||||Drinks consumed per drinking day||Standard Deviation|Mean
1257398|NCT00452543|Primary|Total Drinks Consumed Per Week on the TLFB|Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)||||Drinks consumed per week||Standard Deviation|Mean
1257399|NCT00452543|Primary|Total Drinking Days on the Alcohol Timeline Followback (TLFB)|The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)|Intent to treat sample|||Drinking days||Standard Deviation|Mean
1257400|NCT00452543|Primary|Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)|Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit.|From baseline visit to Week 12 (or early discontinuation visit)||||Scores on a scale||Standard Deviation|Mean
1257401|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)|preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements|||Participants|||Number
1257422|NCT00452400|Secondary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=6 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1257402|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRx<LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx<LLN use <0.9*preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; bicarbonate (mEq/L): <0.75*LLN or >1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRx<LLN use <0.9 *preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRx <LLN use <0.95*preRx or >ULN if preRx>ULN use >1.05*preRx or <LLN; protein, total (g/dL): <0.9*LLN or >1.1*ULN, or if preRx <LLN use 0.9*preRx or >ULN if preRx >ULN use 1.1*preRx or <LLN; CK (U/L): >5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx <LLN use <0.8*preRx or >ULN.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements|||Participants|||Number
1257403|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx <LLN, use <0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; abs basophils: >400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements|||Participants|||Number
1257404|NCT00452530|Secondary|Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Bleeding AEs=all serious or nonserious bleeding-related AEs.|Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1257405|NCT00452530|Primary|Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period|Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.|Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug|The primary efficacy data set (all randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, an adjudicated venous thrombolytic event; or died due to any cause.)|||Percentage of events/patients evaluated||95% Confidence Interval|Number
1257406|NCT00452530|Secondary|Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM|Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment.|Days 1 to 12|All participants who received at least 1 dose of study drug|||Percentage of events/patients evaluated||95% Confidence Interval|Number
1257407|NCT00452530|Secondary|Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.|Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period|||Percentage of events/patients evaluated||95% Confidence Interval|Number
1257423|NCT00452400|Secondary|Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)|AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=3 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1257410|NCT00452452|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine.|||percentage of participants|||Number
1257411|NCT00452452|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1257412|NCT00452426|Secondary|Recovery Time (From Sedation)|Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.|"from scope out until first of two consecutive MOAA/S scores of 5"|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||minutes||Standard Deviation|Mean
1257413|NCT00452426|Secondary|Clinician Satisfaction|Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.|Post procedure|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||Scores on a scale||95% Confidence Interval|Mean
1257414|NCT00452426|Secondary|Patient Satisfaction|Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.|24-48 hours post sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||Scores on a scale||95% Confidence Interval|Mean
1257415|NCT00452426|Secondary|Duration of Deep Sedation/General Anesthesia|Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores.|From first dose until subject recovered from effects of sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||minutes||Standard Deviation|Mean
1257416|NCT00452426|Primary|Area Under the Curve for Oxygen Desaturation (AUCDesat)|AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds*percent.|From administration of initial drug dose until subject recovered from effects of sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||seconds*percent of oxygen desaturation||95% Confidence Interval|Mean
1257417|NCT00452400|Secondary|Laboratory Testing: Average Change From Baseline of Potassium|Laboratory testing: Average change from baseline of potassium measured on test-days. Pre−dose value on test day 1 is the baseline value.|Baseline and day 29|Treated set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||mmol/L||Inter-Quartile Range|Geometric Mean
1257418|NCT00452400|Secondary|Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination|Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.|4 weeks|Treated set including all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||participants|||Number
1257419|NCT00452400|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1257420|NCT00452400|Secondary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1257421|NCT00452400|Secondary|Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)|AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=24 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1257424|NCT00452400|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1257426|NCT00452400|Secondary|Area Under Curve From 0 to 3 Hours (AUC0-3)|AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=3.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1257427|NCT00452400|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol (albuterol))|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Number of puffs||Standard Error|Least Squares Mean
1257428|NCT00452400|Secondary|Weekly Mean Evening PEFR After 4 Weeks|Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter/minute||Standard Error|Least Squares Mean
1257429|NCT00452400|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks|Baseline PEFR was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter/minute||Standard Error|Least Squares Mean
1257430|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257431|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257432|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257433|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|baseline and day1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257434|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257435|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 1 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257436|NCT00452400|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.Means are adjusted using a mixed effects model with baseline,treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257461|NCT00452361|Secondary|Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104||Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257437|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257438|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257439|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours postdose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257440|NCT00452400|Secondary|Peak FVC (0-3h) Response After 4 Weeks|Peak (0-3h) will be the maximum post-dose value during the first 3 hours. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257441|NCT00452400|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257442|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257443|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257444|NCT00452400|Secondary|Trough FVC Response After 4 Weeks|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257445|NCT00452400|Secondary|Trough FVC Response After 2 Weeks|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257462|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 104|Value at Week 104 minus value at baseline.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257463|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 52|Value at Week 52 minus value at baseline.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257446|NCT00452400|Secondary|Trough FVC Response After 1 Week|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257447|NCT00452400|Secondary|Trough FEV1 Response After 2 Weeks|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257448|NCT00452400|Secondary|Trough FEV1 Response After 1 Week|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257449|NCT00452400|Primary|Trough FEV1 Response After 4 Weeks|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
1257450|NCT00452387|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|Overall survival was measured from day 1 of treatment until the end of treatment and then every 3 months thereafter until death.||||Months||95% Confidence Interval|Median
1257451|NCT00452387|Secondary|Quality of Life (QoL)|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The scores for the 6 categories are combined and normalized, and used to describe overall quality of life. Because normalized scores are created using a look-up index, there is no clearly defined maximum value. In practice, the maximum value for the combined scale is 73.5.|The Patient Care Monitor questionnaire was administered on day 1 of every cycle (approximately every 3 weeks) during study treatment.||||units on a scale||Full Range|Mean
1257452|NCT00452387|Secondary|Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging|The test of association assesses the null hypothesis that the frequency of PSA response is the same for patients with and without a favorable imaging response. PSA response required a 50% reduction of the baseline PSA result that was confirmed three weeks later. Favorable imaging response is defined as stable disease, partial response, or complete response per RECIST guidelines. The Fisher’s exact test was used to test this hypothesis.|PSA was evaluated on day 1 of every cycle (approximately every 3 weeks) during study treatment. Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.||||Participants|||Number
1257453|NCT00452387|Primary|Median Time to Progression (TTP) by Imaging|Time to progression is defined as the time from treatment start until objective tumor progression. The median time to progression is the parameter used to describe TTP.|Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.|Survival analysis was performed for 22 patients. However, the upper 95% confidence interval for median TTP could not be calculated and so the number of patients analyzed and the upper 95% confidence interval for median TTP could not be entered into the system.|||Months||95% Confidence Interval|Median
1257454|NCT00452374|Secondary|Number of Participants With a Complete Response or Partial Response|According to International Workshop Response Criteria for Non-Hodgkin's Lymphomas: Complete remission (CR) defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; and Partial remission (PR) defined as > 50% decrease of clinical symptoms from baseline and recovery from blood counts.|Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days||||Participants|||Number
1257455|NCT00452374|Primary|Maximum Tolerated Dose (MTD) Oxaliplatin|MTD defined as dose level at which 2/3 or 2/6 participants experience Dose Limiting Toxicity (DLT), where DLTs are any oxaliplatin-related ≥Grade 3 non-hematological toxicity involving a major organ system (brain, heart, kidney, liver, lung) in the National Cancer Institute (NCI) Version 3.0 toxicity scale.|From treatment onset to end of each cycle of treatment (every 21 days)|Of the 48 study participants, 19 were enrolled in the Phase I MTD group and included in the MTD analysis.|||mg/m^2|||Number
1257456|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104||Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257457|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52||Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257458|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24||Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257459|NCT00452361|Secondary|Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104||Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1258273|NCT00445224|Secondary|Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent||Baseline, Mid and Post-Intervention|||||||
1257468|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257469|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257470|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257471|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257472|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257473|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
1257474|NCT00452361|Primary|Change in Glomerular Filtration Rate (GFR) Change From Baseline|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|104 weeks|No patients completed 104 weeks and therefore no data were available for efficacy analysis.||||||
1257475|NCT00452348|Secondary|Rate of Asthma Attacks Per Participant Per Year|The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a >=20% decrease in AM PEF, a >=70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.|Week 1 through Week 52|ITT Population|||attacks per participant per year||95% Confidence Interval|Mean
1257476|NCT00452348|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52|A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population for which at least 1 week of diary data were provided|||Percentage of symptom-free days||Standard Error|Mean
1257477|NCT00452348|Secondary|Mean Change From Baseline in AM PEF Over Weeks 1-52|Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population who had a minimum of 1 week PEF values|||Liters/minute (L/min)||Standard Error|Mean
1257478|NCT00452348|Primary|Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52|Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Intent-to-Treat (ITT) Population: all participants randomized to study drug who had at least one on-treatment FEV1|||Liters||Standard Error|Mean
1257479|NCT00452335|Secondary|Treatment Effectiveness|Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1257480|NCT00452335|Secondary|Constipation Severity|Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1257481|NCT00452335|Secondary|Pain Associated With SBMs|Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1257482|NCT00452335|Secondary|Abdominal Discomfort|Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1258274|NCT00445224|Secondary|Strength by Isometric Dynamometer||Baseline, Mid, and Post-Intervention|||||||
1257484|NCT00452335|Secondary|Stool Consistency of SBMs|Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1257485|NCT00452335|Secondary|Straining Associated With SBMs|Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1257486|NCT00452335|Secondary|Frequency of Fecal Incontinence|As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.|Weekly, up to 4 weeks|ITT Population|||episodes of fecal incontinence per day||Standard Deviation|Mean
1257487|NCT00452335|Secondary|Frequency of Spontaneous Bowel Movements|Gathered as part of the daily electronic diary questions.|Weeks 2, 3, and 4|ITT Population|||spontaneous bowel movements per week||Standard Deviation|Mean
1257488|NCT00452335|Primary|Frequency of Spontaneous Bowel Movements|Gathered as part of the daily electronic diary questions.|Week 1|ITT population|||spontaneous bowel movements per week||Standard Deviation|Mean
1257489|NCT00452114|Secondary|Quality of Life (Cough-Specific Quality of Life Questionnaire)|"Quality of life is measured using the Cough Specific Quality of Life Questionnaire (CQLQ) to measure the effect of interventions on cough-specific quality of life. The Cough-Specific Quality of Life Questionnaire consist of 28 questions about cough and its effects using Likert-like 4-point scales, with lower scores indicating less effect of cough on health related quality of life.~CQLQ scale ranges from 28 to 112 with higher scores indicating worse outcome or status."|12 months||||Scores on a scale||Standard Deviation|Mean
1257490|NCT00452114|Secondary|Quality of Life (St. George's Respiratory Questionnaire)|Quality of life is measured using St. George's Respiratory Questionnaire, a 50 item disease-specific instrument designed to measure impact on overall health, daily life and perceived well-being in patients with obstructive airways disease. The instrument consists of 2 parts, and 3 components. Part 1 measures symptom frequency and severity with a 1,3 or 12 month recall. Part 1 is evaluated using several scales. Part 2 measures impact of breathlessness on activities including social functioning and psychological disturbances. Part 2 is evaluated by dichotomous (true false) evaluation except the final question which is a 4 point likert scale. Scores range from 0 to 100 with higher score indicating more limitation and lower quality of life.|12 months|Outcomes not analyzed|||scores on a scale||Standard Deviation|Mean
1257491|NCT00452114|Primary|Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits|The impact of the intervention is measured by the number of hospitalizations and urgent/unscheduled outpatient visits the participants experienced within a 12 month period.|12 months||||Number of Hospitalizations/Visits||Standard Deviation|Mean
1257492|NCT00452114|Primary|Number of Suppurative Exacerbations Per Patient Per Year|The impact of the intervention is measured by the total number of suppurative exacerbations per patient within a 12 month period.|12 months||||Number of events per patient||Standard Deviation|Mean
1257493|NCT00451958|Secondary|Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.|||International units/Liter (IU/L)||Full Range|Median
1257494|NCT00451958|Secondary|Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.|||International units/Liter (IU/L)||Full Range|Median
1257495|NCT00451958|Secondary|Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.|||ng/mL||Full Range|Median
1257496|NCT00451958|Secondary|Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.|||ng/mL||Full Range|Median
1257497|NCT00451958|Secondary|Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards|"The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.~In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study."|Until all participants have received at least 5 years of treatment and at a frequency of every 6 months|CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).|||percentage||95% Confidence Interval|Number
1257498|NCT00451958|Secondary|Percentage of Participants With no Prostate-specific Antigen (PSA) Progression|PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).|Until all participants have received at least 5 years of treatment and at a frequency of every 3 months|CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).|||percentage of participants||95% Confidence Interval|Number
1257499|NCT00451958|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.|Up to 4 years of treatment|The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.|||participants|||Number
1257500|NCT00451958|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.|Up to 4 years of treatment|The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.|||participants|||Number
1257501|NCT00451906|Secondary|Number of Participants With Central Nervous System Bleeding|The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.|Up to 3 years|The ITT population was used for analysis, which included all participants with at least one valid post-baseline (Day -28 to -1) assessment. n = number of participants available at the time of assessment who were included in the analysis.|||participants|||Number
1257502|NCT00451906|Secondary|Time to Disease Progression|Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|Up to 3 years|The ITT population was considered for analysis, which included all participants with at least one valid post-baseline (Day -28 to -1) assessment. Participants available at the time of assessment were included in the analysis.|||Months||95% Confidence Interval|Median
1257503|NCT00451906|Secondary|Duration of Overall Survival|Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment. Participants available at the time of assessment were included in the analysis.|||Months||95% Confidence Interval|Median
1257504|NCT00451906|Primary|Number of Participants With Serious Adverse Events Related to Bevacizumab|Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment.|||participants|||Number
1257505|NCT00451906|Primary|Number of Participants With Adverse Events of Special Interest|Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment.|||participants|||Number
1257506|NCT00451698|Secondary|Length of Hospitalization||At hospital discharge, up to 30 days|Analysis was limited to descriptive statistics due to low enrollment and study closure.|||days||Standard Deviation|Mean
1257507|NCT00451698|Secondary|Inotropic Support||24 and 48 hours post operative|These data were not collected||||||
1257508|NCT00451698|Primary|Echocardiographic Assessment of Heart Function||24 hours postop|These data were not collected.||||||
1257509|NCT00451698|Primary|Biochemical Markers of Neuron Damage||4 postoperative time points|There were 43 samples taken from the 9 subjects but no analysis was performed - the laboratory did not set up the assay to run the samples because the study did not have enough subjects to achieve statistical power.||||||
1257510|NCT00451698|Primary|Biochemical Markers of Heart Damage|Troponin I levels (ng/ml) measured at 4 time points|4 postoperative time points up to 48 hours|Analysis was limited to descriptive statistics due to low enrollment and study closure.|||ng/ml||Standard Deviation|Mean
1257511|NCT00451451|Secondary|Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)|EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution|2 years|The analysis population consisted of the intent-to-treat (ITT) population (all subjects who were randomized and received at least 1 dose of study treatment) who had a baseline EDSS assessment. Analyses were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.|||Proportion of Participants|||Number
1257512|NCT00451451|Secondary|Proportion of Subjects Relapsed|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.|2 years|The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for MS, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.|||Proportion of subjects,confirmed relapse|||Number
1257566|NCT00450866|Secondary|Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria|Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)|3 months after treatment|Intention to treat|||participants|||Number
1257513|NCT00451451|Secondary|Number of New T1 Hypointense Lesions|The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.|2 years|Of the 681 subjects in the MRI cohort, 573 (139 placebo,140 BG00012 BID,140 BG00012 TID,154 GA) had post-baseline new T1 hypointense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption|||Number of lesions||95% Confidence Interval|Mean
1257514|NCT00451451|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.|2 years|Of the 681 subjects in the MRI cohort, 572 (139 placebo, 140 BG00012 BID, 140 BG00012 TID, 153 GA) had post-baseline T2 hyperintense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption.|||Number of lesions||95% Confidence Interval|Mean
1257515|NCT00451451|Primary|Annualized Relapse Rate|"A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.~The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment."|2 years|The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.|||Relapses Per Year||95% Confidence Interval|Mean
1257516|NCT00451321|Secondary|Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)|Participants were seen weekly during the first 4 weeks post-dose and then every other week through Week 12. After Week 12, visits occurred every 1 to 3 months through Month 18, which completes the Core Study up to Month 48 (follow up). Day 1 pre-dose value was considered as Baseline value. Change from Baseline was post-Baseline value minus Baseline value.|Baseline and up to Month 48|PD summary Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Data for only quantifiable concentration is presented.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
1257517|NCT00451321|Secondary|Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days|Ibuprofen (analgesic) was given orally as follows: 400-800 mg 2 hour before SOI, 400-800 mg 2 hour after SOI, 400-800 mg 6 hour after SOI, and 400-800 mg at bedtime. If ibuprofen was contraindicated, acetaminophen was used in place of ibuprofen. Acetaminophen doses were adjusted so as it did not exceed 1000 mg per 6 hour or 4000 mg per day. A non-sedating antihistamine (cetirizine) was administered approximately 1 hour prior to each infusion of study drug. The recommended initial dose of cetirizine was 5 mg or 10 mg per day in adults and children aged 12 years and older. Normal saline solution was administered IV as needed to maintain hydration.|Up to Day 8|All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
1257518|NCT00451321|Secondary|Number of Participants With Detectable Anti-otelixizumab Antiglobulin Response|Anti-otelixizumab antibody levels were determined by ELISA. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.|Up to Month 48|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.|||Participants|||Count of Participants
1257519|NCT00451321|Secondary|CD3/TCR Complexes on CD4+ and CD8+ T Cells|Samples were planned to analyze at the Screen visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|At the Screen visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|PD summary Population. Data was not collected for this endpoint.||||||
1257520|NCT00451321|Secondary|Saturation of CD4+ and CD8+ T Cells With Otelixizumab|Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|PD summary Population. Data was not collected for this endpoint.||||||
1257521|NCT00451321|Secondary|Amounts of Cell-bound Otelixizumab on CD4+ and CD8+ T Cells|Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|PD summary Population. Data was not collected for this endpoint.||||||
1257522|NCT00451321|Secondary|Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count|One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.|Day 8 and 28|PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.|||Percentage of lymphocytes||Standard Deviation|Mean
1258275|NCT00445224|Primary|Subjective Function by Lower Extremity Functional Scale Report Form||Baseline, Mid-Intervention, and Post-Intervention|||||||
1257523|NCT00451321|Secondary|Mean CD4+/CD8+ Ratio|One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. CD4+/CD8+ ratio was determined by dividing the absolute count of CD4+ T cells by the absolute count of CD8+ T cells for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.|Day 8 and 28|PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.|||Ratio||Standard Deviation|Mean
1257524|NCT00451321|Secondary|Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count|One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD4+ T cells, CD8+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.|Day 8 and 28|PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.|||Cells per microliter||Standard Deviation|Mean
1257525|NCT00451321|Secondary|Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count|One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD19+ B cells, CD4+CD25hiFoxP3+ T cells, CD8+CD25+FoxP3+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. The ‘Pharmacodynamic (PD) summary population' was defined as participants in the ‘All Subjects’ Population for whom a PD sample was obtained and analyzed and who received the full scheduled dose, as specified in the protocol.|Day 8 and 28|Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.|||Cells per microliter||Standard Deviation|Mean
1257526|NCT00451321|Secondary|Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab|PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.|At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.|PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.|||hour||Full Range|Median
1257527|NCT00451321|Secondary|Maximum Plasma Drug Concentration (Cmax) of Otelixizumab|PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.|At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.|PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1257528|NCT00451321|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab|Pharmacokinetic (PK) samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 micrograms per milliliter (µg/mL). The ‘PK summary Population' was defined as participants in the ‘All Subjects’ Population for whom a pharmacokinetic sample was obtained and analyzed, and who received the full scheduled dose, as specified in the protocol. Only those participants available at the specified time points were analyzed.|At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-start of infusion (SOI). On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.|PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1257529|NCT00451321|Primary|Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load|EBV load was measured using quantitative polymerase chain reaction (PCR) method. If a participant had an EBV viral load of >100,000 copies/10^6 peripheral blood mononuclear cells (c/10^6 PBMC) lymphocytes at any time post-dose, the test was repeated immediately. Data for participants with abnormal viral load is presented.|Up to Month 18|All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
1257567|NCT00450866|Secondary|CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria|Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)|3 months after treatment|Intention to treat|||participants|||Number
1288245|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48||Month 48||||L||Standard Error|Mean
1257530|NCT00451321|Primary|Mean Overall Maximum Cytokines Level|Levels of cytokines: interferon (IFN)-gamma, interleukin (IL)-10, IL-6 and tumor necrosis factor (TNF)–alpha were assessed. One sample was collected at Baseline, on dose Day 1 at 1, 2, 3, and 8 hours post-end of infusion (EOI) and on all other dosing days at pre-dose, and 1, 2, 3, and 8 hour post-EOI. After the completion of dosing, on Day 21 and Week 8, only the IL-10 level was assessed in the cytokine blood sample.|Up to Week 8|All subjects Population. Only those participants available for analysis for the particular parameter are presented. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
1257531|NCT00451321|Primary|Number of Participants With Abnormal Urinalysis Dipstick Results|Urinalysis parameters: Occult blood, Glucose urine, Ketones, Leukocyte esterase, Nitrite, pH, Protein urine were assessed. Abnormal values for occult blood and ketones were presented as 1+, 2+ and 3+ (the plus sign increases with a higher level of parameters: 1+=slightly positive, 2+=positive, 3+=high positive). Abnormal glucose urine values were presented as 50, 100, 250 and 1000 mg/dL. Abnormal nitrite values were presented as ‘positive’, and abnormal urine protein values were presented as 30 and 100 mg/dL.|Up to Month 48|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
1257532|NCT00451321|Primary|Number of Participants With Abnormal Clinical Chemistry Values of PCC|Clinical chemistry parameters: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transferase, lactate dehydrogenase, lipids, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, carbon dioxide, creatinine phosphokinase, albumin, calcium, magnesium, glucose, phosphate, bicarbonate and total protein were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.|Up to Month 48|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
1257533|NCT00451321|Primary|Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)|Hematology parameters: hemoglobin, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.|Up to Month 48|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
1257534|NCT00451321|Primary|Number of Participants With Cytokine Release AE|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Cytokine release AEs were defined as occurring during dosing or within a limited time window after the last dose.|Up to Month 24|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
1257535|NCT00451321|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Month 24|The ‘All Subjects population’ was defined as all participants who received at least one dose of study medication and was used in all study population and safety analyses. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
1257536|NCT00451282|Secondary|Health Service Utilization Over the 6 Months Post-injury|Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.|6 months|||||||
1257537|NCT00451282|Secondary|Adherence With Medical Discharge Instructions|The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers’ contacts with study participants, including whether psychosocial concerns were identified since the injury.|6 months|||||||
1257538|NCT00451282|Secondary|Health-related Quality of Life 6 Weeks and 6 Months Post-injury|The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.|6 months|||||||
1257539|NCT00451282|Secondary|Depression Symptoms in Children 6 Mos Post-injury|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.|6 months|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 week follow-up.|||Units on a scale||Standard Deviation|Mean
1283833|NCT00216203|Secondary|Median Survival Time||24 Months|27 participants had data sufficient to complete Median Survival Time analysis|||weeks||95% Confidence Interval|Median
1257540|NCT00451282|Secondary|Depression Symptoms in Children 6 Wks Post-injury|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.|6 weeks|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.|||Units on a scale||Standard Deviation|Mean
1257541|NCT00451282|Primary|PTSD Symptoms in Children 6 Months Post-injury|The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.|6 months|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 month follow-up.|||Units on a scale||Standard Deviation|Mean
1257542|NCT00451282|Primary|PTSD Symptoms in Children 6 Weeks Post-injury|The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.|6 weeks|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.|||Units on a scale||Standard Deviation|Mean
1257543|NCT00451204|Other Pre-specified|Relapse Event, Annualized Relapse Rate|Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.|12 months||||relapses per year||95% Confidence Interval|Mean
1257544|NCT00451204|Other Pre-specified|Confirmed Relapse, Annualized Relapse Rate|A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.|12 months||||relapses per year||95% Confidence Interval|Mean
1257545|NCT00451204|Secondary|Relapse Event, Probability of First Relapse Event||24 months|Included all as intention to treat|||probability of relapse event at 24 mo||95% Confidence Interval|Mean
1257546|NCT00451204|Secondary|Confirmed Relapse, Probability of First Relapse||24 months|All included as intention to treat|||probability of relapse at 24 months||95% Confidence Interval|Mean
1257547|NCT00451204|Secondary|Relapse Event, Annualized Relapse Rate|Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.|24 months|Included all as intention to treat.|||relapses per year||95% Confidence Interval|Mean
1257548|NCT00451204|Primary|Confirmed Relapse, Annualized Relapse Rate|A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.|24 months|Included all as intention to treat|||relapses per year||95% Confidence Interval|Mean
1257549|NCT00451191|Primary|Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.|The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) >=40% of the participants reported a moderate or severe side effect related to the botulinum toxin injection.|12 weeks|By the last 12-month follow-up visit, 15 men (22%) in the 100 U dose arm and 11 (17%) in the 300 U dose arm had withdrawn due to dissatisfaction with treatment results or continued to attend study follow-up but received additional alternate treatment prior to 12 months.|||participants|||Number
1257550|NCT00451048|Secondary|Highest Severity of Observed Adverse Events Assessed by Common Terminology Criteria or Adverse Events Version 3.0 (CTCAE v3.0)||Up to 6 years||||highest grade of adverse event reported|||Number
1257551|NCT00451048|Secondary|Time to Progression||At 6 months and 1 year|Date were not collected||||||
1257552|NCT00451048|Secondary|Progression-free Survival||At 6 months and 1 year|Data were not collected||||||
1257553|NCT00451048|Secondary|Overall Survival||At 6 months and 1 year||||months||95% Confidence Interval|Median
1257554|NCT00451048|Secondary|Number Participants With Complete, Partial or Hematologic Improvement Response|Assessed by achievement of Complete Response (CR), Partial Response (PR) or Hematologic Improvement (HI)|Up to 6 years|No patient achieved CR, PR or HI as response.|||participants|||Number
1257555|NCT00451048|Primary|Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria||Up to 6 years||||percentage of participants|||Number
1257569|NCT00450866|Primary|Central Nervous System (CNS) Progression-free Survival(PFS)|"The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.~PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death."|3 months after treatment|Intention to treat|||participants|||Number
1257570|NCT00450801|Secondary|Number of Patients Experiencing Adverse Events.|Number of patients experiencing adverse events during the course of protocol therapy.|Up to 5 years||||participants|||Number
1257571|NCT00450801|Secondary|Response Rate|Percentage of participants achieving complete response (CR) to protocol therapy according to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) using the CT imaging method. Patients were classified by best tumor response; CR was defined as normalization of the lactate dehydrogenase (LDH), complete disappearance of disease-related symptoms and lymph nodes, and clearance of lymphoma from involved organs; complete response unconfirmed (CRu) as a residual lymph node greater than 1.5 cm in greatest transverse diameter that had regressed by more than 75% or an indeterminate bone marrow examination; partial response (PR) as greater than 50% reduction in the involved lymph nodes, or disappearance of the involved lymph nodes but persistent bone marrow involvement; relapse/progression as new or increased lymph nodes, organomegaly, or reappearance of bone marrow involvement.|Up to 5 years|Participants who completed at least two cycles of therapy.|||percentage of participants||95% Confidence Interval|Number
1257572|NCT00450801|Secondary|Overall Survival Rate|Percentage of participants who are alive up to five years after receipt of protocol therapy.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1257573|NCT00450801|Primary|Progression-free Survival Rate|Percentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1257574|NCT00450749|Secondary|Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue||At 4-7 weeks|||||||
1257575|NCT00450749|Secondary|Histological Characteristics of Prostatic Surgical Tissue||At 4-7 weeks|||||||
1257576|NCT00450749|Secondary|Expression of GST-pi in Prostatic Surgical Tissue||At 4-7 weeks|||||||
1257577|NCT00450749|Secondary|Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay||At baseline and at 4-7 weeks|||||||
1257578|NCT00450749|Secondary|Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3||At baseline and at 4-7 weeks|||||||
1257579|NCT00450749|Secondary|Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue||At 4-7 weeks|||||||
1257580|NCT00450749|Secondary|Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2||Baseline and at 4-7 weeks|||||||
1257581|NCT00450749|Secondary|Ratio of T:DHT in Prostatic Surgical Tissue||At 4-7 weeks|||||||
1257582|NCT00450749|Secondary|Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum||Baseline and at 4-7 weeks|||||||
1257583|NCT00450749|Primary|Change in Serum Lycopene Concentration|The differences in the mean of the 6 week (± 1 week) serum lycopene concentrations after adjusting for baseline serum lycopene concentrations calculated between the three arms, together with 95% confidence intervals.|Baseline and at 4-7 weeks|||||||
1257584|NCT00450749|Primary|Concentration of Lycopene in Prostatic Surgical Tissue|Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.|At 4-7 weeks|Tissue samples collected from five participants for measurement of lycopene levels, representing only 50% (5 of 10) of the participants’ enrolled on-trial.|||ug/dL|||Number
1257585|NCT00450723|Primary|Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes||5 years|Of the 39 patients enrolled, 34 had identifiable internal mammary sentinel lymph nodes.|||participants|||Number
1257586|NCT00450723|Primary|Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes||5 years||||participants|||Number
1257587|NCT00450723|Primary|Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy||5 years||||participants|||Number
1257588|NCT00450658|Secondary|The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.|The secondary efficacy endpoint was the number of subjects developing a NSAID-associated serious GI complication at any time throughout 6 months of treatment. A NSAID-associated serious GI complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or GI bleeding.|24 weeks|All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic exam. Subjects were assigned according to the treatment to which they received.|||participants|||Number
1257589|NCT00450658|Secondary|Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of subjects with duodenal ulcer at any time throughout the 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks||||participants|||Number
1257590|NCT00450658|Secondary|Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit were performed.|||participants|||Number
1284557|NCT00204373|Secondary|The Median Survival From the Time of Diagnosis.|The median survival from the time of diagnosis|survival or up to 240 months||||years||Standard Deviation|Median
1257591|NCT00450658|Primary|Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.|The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination.|||participants|||Number
1257592|NCT00450619|Secondary|Palliation: Improvement in Baseline Pain|Subjective report of participant pain at baseline. This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.|post quadramet (samarium)||||participants|||Number
1257593|NCT00450619|Secondary|Palliation: Pain at Baseline|Subjective report of participant pain at baseline.This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.|Baseline||||participants|||Number
1257594|NCT00450619|Secondary|Objective Response (Complete Response + Partial Response)|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD.|4 weeks|Not all participants was measureable by RECIST.|||participants|||Number
1257595|NCT00450619|Secondary|Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment|PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).|Approximately 60 days|(a)Cytokine or CD107a in CD4 or CD8. *Pts displayed pre-existing PSA-specific T-cell responses. Numbers 786, 374, 345, 402, 821, 815, 5269, 453, 633, 1242 & 0 for PT 2 CD4/CD8 IL2 & 0 for PT 16 TNF are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.|||Absolute # CD4 or CD8 producing cytokine|||Number
1257596|NCT00450619|Secondary|Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment|PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).|Approximately 60 days|(a)Cytokine or CD107a in CD4 or CD8. *Pts displayed pre-existing PSA-specific T-cell responses. Numbers 274, 630, and 1427 are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.|||Absolute # CD4 or CD8 producing cytokine|||Number
1257597|NCT00450619|Secondary|Overall Survival|Time from treatment start date until date of death or date last known alive.|From date of randomization until death or last follow up, whichever comes first, assessed up to 14 months.||||Months||95% Confidence Interval|Median
1257598|NCT00450619|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) ≥50%|PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.|4 months||||participants|||Number
1257599|NCT00450619|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30%|PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.|4 months||||participants|||Number
1257600|NCT00450619|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|5 years, 5 months||||Participants|||Number
1257601|NCT00450619|Primary|Progression Free Survival (PFS)|PFS is defined as the time to progress or die after the start of the therapy.|4 months||||months||95% Confidence Interval|Median
1257602|NCT00450619|Primary|Number of Patients With Stable Disease at 4 Months.|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable disease is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions on computed tomography (CT) or two or more lesions on bone scan.|4.7 months||||participants|||Number
1257603|NCT00450580|Secondary|Study Endpoints for a Subset of Subjects Receiving Study Drug Beyond 48 Weeks|Adaptive two-stage design study up to 48 weeks. N=200, expanding to 728 if continuation criteria were achieved based on a 24-week interim analysis. The initial 200 participants would continue until the last subject of the expanded cohort reached 48 weeks and would constitute the subset. As continuation criteria were not achieved, the study did not proceed to the second stage, and full analysis was performed on the initial 200 participants only.|Up to 60 weeks|||||||
1257604|NCT00450580|Secondary|Steady-state Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 4, 12, and 24|Blood samples were drawn at Weeks 4, 12, and 24 to determine plasma concentrations (Ctau) of APV and RTV|Weeks 4, 12, and 24|PK parameter (Ctau) Population – Participants in the ITT-E population who underwent PK sampling and had evaluable APV Ctau or RTV Ctau data|||micrograms/mL||95% Confidence Interval|Geometric Mean
1257605|NCT00450580|Secondary|Number of Protocol-defined Virological Failures With Genotypic and Phenotypic Resistance Changes|A blood sample was drawn at the time of confirmation of virological failure, and mutations present in the virus were identified and compared to those found in the blood sample at baseline. New mutations were tabulated by drug class. RT, reverse transcriptase. Virological failure could occur anytime from Week 4 to Week 48.|Time to virologic failure; Week 4 up to Week 48|Participants in the ITT-E Population who met the definition of virological failure|||Participants|||Number
1257606|NCT00450580|Secondary|Change From Baseline in Non-HDL Cholesterol at Week 48|Blood samples were drawn to determine the non-HDL cholesterol levels at Week 48. The mean absolute change in non-HDL cholesterol was defined as the Week 48 levels minus levels at baseline.|Week 48|Safety Population: all participants who received at least one dose of study medication|||mmol/L (millimoles/Liter)||Standard Deviation|Mean
1257607|NCT00450580|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline CD4+ Count, TLOVR Analysis|The number of participants with HIV-1 RNA <400 copies/mL at week 48 was determined (by analysis of blood draw) and categorised by baseline CD4+ count.|Week 48|ITT-E Population|||Participants|||Number
1257608|NCT00450580|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline Viral Load, TLOVR Analysis|The number of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined (by analysis of blood draw) and categorised by baseline viral load (BVL).|Week 48|ITT-E Population|||Participants|||Number
1257609|NCT00450580|Secondary|Percentage of Participants With HIV-1 RNA <50 and >=50 Copies/mL by Visit Over 48 Weeks|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined by the TLOVR algorithm|Week 48|ITT-E Population|||Percentage of participants|||Number
1257610|NCT00450580|Primary|Percentage of Participants With HIV-1 RNA <400 and >=400 Copies/mL Over 48 Weeks|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined by the Time to Loss Of Virologic Response (TLOVR) algorithm.|Week 48|Intent-to-Treat-Exposed (ITT-E) Population: All randomised participants who received at least one dose of study medication|||Percentage of participants|||Number
1257611|NCT00450463|Secondary|Percentage of Participants With Antigen Specific Immune Responses Against Prostatic Specific Antigen (PSA)|Antigen specific responses were evaluated using intracellular cytokine staining of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) cells (evaluating cluster of Differentiation 107a (CD107a), INFg, Interleukin-2 (IL-2), and tumor necrosis factor (TNF) for CD4+ and CD8+ T-cells. Peripheral blood mononuclear cells were separated by Ficoll-Hypaque density gradient separation, washed three times, and preserved in 90% heat-inactivated human A and B blood-type antigens) AB serum and 10% Dimethyl sulfoxide (DMSO) in liquid nitrogen at a concentration of 1 × 10^7 cells/mL until assayed. Analysis of antigen-specific responses following therapy was assessed by intracellular cytokine staining following a period of in vitro stimulation with overlapping 15-mer peptide pools. A more complete description can be found at Heery CR et al, Cancer Immunol Res. 2015 Nov;3(11):1248-56.|3 months||||percentage of participants|||Number
1257612|NCT00450463|Secondary|Number of Participants With Prostatic Specific Antigen (PSA) Response|Complete response is PSA <0.2 confirmed by a second reading at least 4 weeks later. All patients with a PSA decline of >50% (confirmed by a second value at least 4 weeks after the first) and who have no other evidence of disease progression will be reported with both PSA decline only and PSA decline and stable disease on scans. A 25% increase in PSA over nadir is progressive disease with or without evidence of metastatic disease, and/or development of disease on scans or a second occurrence of rising PSA levels in the absence of clinical progression.|Median potential follow-up for all patients is 46.7 months|Although patients without radiographic progression were allowed to get vaccine after progression on flutamide, the primary comparison in the two groups of this study was Flutamide alone vs. Fluatmiade + vaccine simultaneously.|||Participants|||Count of Participants
1257613|NCT00450463|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Median Potential Follow-up of 46.7 months||||Participants|||Count of Participants
1257614|NCT00450463|Primary|Time to Treatment Failure|Time to treatment failure is defined as a rising Prostatic Specific Antigen (PSA) (Bubley criteria, JCO 1999), development of metastatic disease, or removal from treatment due to excessive toxicity) compared to patients receiving flutamide alone. Normal PSA is 4.0 ng/mL or lower.|Median Potential Follow-up of 46.7 months|Although patients without radiographic progression were allowed to get vaccine after progression on flutamide, the primary comparison in the two groups of this study was Flutamide alone vs. Fluatmiade + vaccine simultaneously. Thus the data on TTF presented is for progression on flutamide alone.|||Months||Full Range|Median
1257615|NCT00450450|Other Pre-specified|Infused Nucleated and CD34+ Cell Doses|Compared using the Wilcoxon rank-sum test.|Up to 10 years|Data are not collected for this study.||||||
1257616|NCT00450450|Other Pre-specified|Immune Reconstitution|Summarized graphically. Generalized estimating equation will be used to model the levels as a function of time and randomization assignment and to test the impact of G-CSF stimulation on immune reconstruction.|Up to 1 year|Data are not collected for this study.||||||
1257617|NCT00450450|Secondary|Estimated Median Length of Initial Hospitalization|Estimated and compared between randomization arms using the Wilcoxon rank-sum test.|Up to 10 years|Data regarding length of Initial Hospitalization are not collected for this study according to Study Chair.||||||
1257618|NCT00450450|Secondary|Estimated Median Time to Neutrophil Engraftment|Median Time from transplant to neutrophil engraftment|Up to 10 years|One patient was inevaluable and excluded from the analysis.|||Days||95% Confidence Interval|Median
1257619|NCT00450450|Secondary|Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)|cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.|18 months post-transplant|Included only patients survived beyond 100 days.|||percentage of patients|||Number
1257620|NCT00450450|Secondary|Estimated 100-day Transplant Related Mortality (TRM) Percentage|Death in a patient after transplant due to protocol treatment is defined as an TRM.|100 days|One patient is inevaluable and is excluded from analysis.|||percentage of patients|||Number
1285429|NCT00191451|Secondary|Number of Patients Who Experienced Alopecia||Baseline to 3.5 years|Number of patients who received at least one dose of study drug.|||participants|||Number
1257623|NCT00450450|Primary|Estimated Two-year Event-free Survival (EFS)|EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.|at 2 years|Early terminated study. One patient is inevaluable for EFS on experimental arm and is excluded from analysis.|||Percentage of patients||95% Confidence Interval|Number
1257624|NCT00450437|Primary|Percentage of Seroresponders, Ages 19 to 55 Years|"Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analysis set was the per protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Number
1257625|NCT00450437|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years|Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).|Days 1 to 7|The analysis was performed on the safety set.|||Participants|||Number
1257626|NCT00450437|Secondary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years|Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).|28 days after vaccination|The analysis set was the per protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
1257627|NCT00450437|Secondary|Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years|"Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analyses set was performed on the per protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Number
1257628|NCT00450437|Secondary|Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years|"The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The Analysis set was the per protocol (PP) population.|||Percentage of Participants||95% Confidence Interval|Number
1257629|NCT00450437|Primary|Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years|"Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.~Note: severe adverse events: unable to perform normal daily activity"|6 days after vaccination|The analysis was performed on the safety set.|||Participants|||Number
1257630|NCT00450437|Primary|Percentage of Seroresponders, Ages 11 to 18 Years|"Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analysis set was the per protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Number
1257631|NCT00450437|Primary|Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years|The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)|28 days after vaccination|The analysis was performed on the Per Protocol (PP) Population|||Titers||95% Confidence Interval|Geometric Mean
1257632|NCT00450424|Secondary|Patient Satisfaction With the Preparation to Make a Decision|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU).|at enrollment and 2 weeks after enrollment|||||||
1257633|NCT00450424|Secondary|Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU). Impact of demographic factors, disease/family history characteristics, family support, and cancer-related distress on satisfaction with and completeness of the informed consent process was measured|at enrollment and 2 weeks after enrollment|||||||
1257634|NCT00450424|Secondary|Differential Impact of CD-ROM on Satisfaction With MSI Test Decision, Difficulty Making Decision & Decisional Conflict; Attitude; General & Cancer-related Distress; Discussions With Family About MSI Test & Familial Colorectal Cancer Risk|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU). Differential impact of CD-ROM on satisfaction with MSI test decision, difficulty making decision & decisional conflict; attitude; general & cancer-related distress; discussions with family about MSI test & familial colorectal cancer risk were measured.|at enrollment and 2 weeks after enrollment|||||||
1257635|NCT00450424|Primary|Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing|"10-item true/false MSI knowledge survey developed by the oncologists on trial. (e.g., Microsatellite Instability is found in every person that has had cancer.; Microsatellite Instability may be caused by a permanent change in a gene that is inherited from a person’s mother or father.). Participants can score anywhere from 0 (no questions answered correctly) to 10 (all questions answered correctly)."|2 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1257636|NCT00450411|Secondary|Biochemical (PSA) Failure||From registration to 5 years||2019-05-31|05/2019||||
1257637|NCT00450411|Secondary|Distant Failure||From registration to 5 years||2019-05-31|05/2019||||
1257638|NCT00450411|Secondary|Local Tumor Progression||From registration to 5 years||2019-05-31|05/2019||||
1257639|NCT00450411|Secondary|Disease-specific Survival||From registration to 5 years||2019-05-31|05/2019||||
1257640|NCT00450411|Secondary|Disease-free Survival||From registration to 5 years||2019-05-31|05/2019||||
1257641|NCT00450411|Secondary|Overall Survival||From registration to 5 years||2019-05-31|05/2019||||
1257642|NCT00450411|Secondary|Number of Patients With Acute Treatment-related GI and GU Adverse Events|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, acute treatment-related adverse events will be evaluated within 270 days from the implant.|From date of implantation to 270 days|Eligible patients who received protocol treatment with at least 270 days of follow-up from the date of implantation|||Participants|||Count of Participants
1257643|NCT00450411|Primary|Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.|Between 271 days and 730 days from date of implantation|Eligible patients who received protocol treatment with at least 23 months follow-up from the date of implantation|||Participants|||Count of Participants
1257644|NCT00450385|Secondary|Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.|Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies.|Baseline||||Participants|||Count of Participants
1257645|NCT00450385|Secondary|Overall Response Rate of Study Participants at the End of Protocol Therapy|Rate of participants achieving complete response (CR), complete response/unconfirmed (CRu) partial response (PR) according to Non-Hodgkin's Lymphoma response criteria.|Up to 8 cycles, about 24 weeks||||Participants|||Count of Participants
1257646|NCT00450385|Secondary|Determination of the Ability of Models and/or Biomarkers Associated With Anti-Tumor Effects of Rituximab to Predict 24-month Time to Treatment Failure in DLBCL Patients Receiving R-CHOP Therapy|The investigators aim to determine the ability of the models and/or biomarkers associated with the anti-tumor effects of rituximab to predict 24-month time to treatment failure, defined as disease progression, death or initiation of new treatment.|24 Months|The determination could not be made because the study required a minimum of 90 participants for biomarker analyses and derivation of survival prediction model(s). Due to actual participant accrual (57) being far below the minimum required, no data were collected on the ability of models and/or biomarkers to predict time to treatment failure.||||||
1257647|NCT00450385|Primary|Comparison of the Ability of Constructed Survival Models to Predict Overall Survival in DLBCL Patients Receiving R-CHOP Therapy|The investigators will compare the ability of constructed survival models to predict survival in DLBCL patients receiving R-CHOP therapy|2 Years|The comparison could not be made because the study required a minimum of 90 participants for initial gene expression analyses from which survival prediction model(s) would be derived. Due to actual participant accrual (57) being far below the minimum number of participants required, no gene expression or survival prediction data were collected.||||||
1257648|NCT00450385|Primary|Usefulness of Biomarkers Associated With Anti-Tumor Effects of Rituximab in Predicting Overall Survival in DLBCL Patients Receiving R-CHOP Therapy|The investigators aim to determine the usefulness of biomarkers associated with the antitumor effects of rituximab (e.g. immunoglobulin GFc receptor genotypes, CD20 protein expression and gene expression profiles) to predict overall survival of DLBCL patients treated with R-CHOP therapy and followed for at least 24 months or until death.|24 Months|The study required a minimum of 90 participants for associated biomarker analyses. Due to actual participant accrual (57) being far below the minimum number of participants required, no biomarker data were collected.||||||
1257649|NCT00450385|Primary|Determination of a List of Genes and Construction of Survival Prediction Models That Will Predict Overall Survival at 30 Months in DLBCL Patients Receiving R-CHOP Therapy.|The investigators aim to determine a list of genes and construct survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy. Overall survival time will be calculated from the date of the diagnosis until death or last follow-up examination.|30 months|The study required a minimum of 90 participants for gene expression analyses from which survival prediction model(s) could be derived. Due to actual participant accrual (57) being far below the minimum number of participants required, no data were collected on gene expression, and no survival prediction models were constructed.||||||
1257650|NCT00450372|Secondary|Median Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.|||months||95% Confidence Interval|Median
1257651|NCT00450372|Secondary|Median Overall Survival|Overall survival will be estimated using the product-limit method of Kaplan & Meier.|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.|||months||95% Confidence Interval|Median
1257652|NCT00450372|Primary|Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.|Response rate is defined as a partial response, PR, and complete response, CR, lasting for at least 30 days per RECIST criteria, v. 1.0. Complete response will be defined as disappearance of all target lesions. Partial response will be defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference the baseline sum of LD|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.|||participants|||Number
1257653|NCT00450333|Secondary|Change From Baseline in Hematocrits at 16 and 24 Weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Baseline and Weeks 16 and 24|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.||||||
1257654|NCT00450333|Secondary|Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|week 16 and 24|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.||||||
1257655|NCT00450333|Primary|Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Baseline and 24 weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.||||||
1257656|NCT00450294|Primary|Left Intraocular Pressure|Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.|Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure||||mm Hg||Standard Error|Least Squares Mean
1257657|NCT00450294|Primary|Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.|Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.|Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure|The analysis was per protocol.|||mm Hg||Standard Error|Least Squares Mean
1257658|NCT00450255|Secondary|Impact of the VEGF Trap Therapy on Laboratory Correlates||Up to 5 years|Laboratory Correlate data were not collected.||||||
1257659|NCT00450255|Secondary|Number of Participants With Toxicities|The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for AE grading and reporting. Grade 3 and higher adverse events considered possibly, probably or definitely related to aflibercept are summarized.|Up to 5 years||||Participants|||Count of Participants
1257660|NCT00450255|Secondary|Overall Survival|Will be estimated by the Kaplan-Meier method.|From the initial date of treatment to the recorded date of death, assessed up to 5 years||||Months||95% Confidence Interval|Median
1257661|NCT00450255|Primary|4 Month Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 months||||percentage of patients||95% Confidence Interval|Number
1257662|NCT00450255|Primary|Objective Response Rate (CR + PR)|"Using the RECIST v1.0 criteria for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR.,"|Start of treatment to disease progression/recurrence, up to 5 years||||percentage of participants||95% Confidence Interval|Number
1257663|NCT00450242|Secondary|Modified Gracely Pain Scale|The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8).|baseline, week 8|The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.|||units on a scale|||Number
1257664|NCT00450242|Secondary|SF-12 Quality of Life Scores|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age.|baseline, week 8|The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.|||units on a scale|||Number
1257665|NCT00450242|Primary|Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8|"Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The mean listed for each group is average week 8 score subtracted from the average baseline score."|baseline, week 8|three lidocaine subjects and one control subject failed to complete the study.|||units on a scale||Standard Deviation|Mean
1257666|NCT00450242|Primary|Number of Participants Who Report the Ability to Have Intercourse|Participants' response upon inquiry.|baseline, week 8|Three lidocaine subjects and one control subject failed to complete the study.|||participants|||Number
1257667|NCT00450216|Secondary|The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding)|The secondary efficacy endpoint was the number of participants developing a NSAID-associated serious gastrointestinal complication at any time throughout 24 weeks of treatment. A NSAID-associated serious gastrointestinal complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or gastrointestinal bleeding.|24 weeks||||particpants|||Number
1257668|NCT00450216|Secondary|Number of Participants Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of participants with duodenal ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks||||participants|||Number
1257669|NCT00450216|Secondary|Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of participants with UGI (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks||||participants|||Number
1257670|NCT00450216|Primary|Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers|The primary efficacy endpoint was the number of participants with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination. Participants were assigned according to the treatment to which they were randomized; 2:1 randomization, HZT-501:ibuprofen.|||participants|||Number
1257671|NCT00450190|Secondary|Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.|Day 1 up to Day 90|All subjects who were administered with at least 1 dose of study medication with E-Device.|||subjects|||Number
1257672|NCT00450190|Secondary|Nurse/Physician’s Feedback After E-Device Set up During Inclusion Visit|Nurse/physician’s feedback was assessed for E-Device setting up and Dose programming on inclusion visit using a scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Nurse/Physician’s response for the number of subjects were presented.|Inclusion visit (Day 1)|All included subjects were analyzed who used at least 1 dose of study medication with E-Device.|||subjects|||Number
1257673|NCT00450190|Secondary|Subjects' Feedback Immediately After Initial Training During Inclusion Visit|Subjects’ feedback immediately after initial training on the handling and use of E-Device was assessed on scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Subjects were provided training on the following aspects: Cartridge loading, Needle attachment, Needle detachment, Injection process, Navigation in the menu, and Handling of the device. Number of subjects with response based on their feedback were presented.|Inclusion visit (Day 1)|All subjects who were administered with at least 1 dose of study medication with E-Device.|||subjects|||Number
1257674|NCT00450190|Primary|Usefulness and Reliability of E-Device Functions|Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented.|2 Weeks|All subjects who were administered with at least 1 dose of study medication with E-Device.|||subjects|||Number
1257675|NCT00450190|Primary|Subjects' Overall Impression After Using E-Device|Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented.|2 Weeks|All subjects who were administered with at least 1 dose of study medication with E-Device.|||subjects|||Number
1257676|NCT00450112|Secondary|Acetaminophen Consumption|Weekly mean acetaminophen consumption between weeks 9 and 13.|Week 9 to Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||milligrams||Standard Deviation|Mean
1257677|NCT00450112|Secondary|Improvement From Baseline in Physician Global Evaluations|Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
1257678|NCT00450112|Secondary|Improvement From Baseline in Subject Global Evaluations|Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
1258276|NCT00445224|Primary|Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)|0 to 10 cm line with 0 representing no pain and 10 representing severe pain|weekly||||centimeter||Standard Deviation|Mean
1257679|NCT00450112|Secondary|Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response|Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).|Weeks 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||Percentage of Participants|||Number
1257680|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Total Score)|Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
1257681|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Physical Function Subscore)|Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
1257682|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Stiffness Subscore)|Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
1257683|NCT00450112|Secondary|Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)|Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
1257684|NCT00450112|Primary|Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200||13 weeks||||participants|||Number
1257685|NCT00450073|Secondary|Parathyroid Hormone, Serum C-telopeptide, Osteocalcin||12 weeks|||||||
1257686|NCT00450073|Primary|25-hydroxyvitamin D|This is a marker of vitamin D status|12 weeks||||ng/mL||Standard Deviation|Mean
1257687|NCT00449956|Secondary|Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks|Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)|8 weeks|Last observed value during the 8-week treatment period was used in the FAS.|||Percent Change||95% Confidence Interval|Least Squares Mean
1257688|NCT00449956|Secondary|Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks|Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)|8 Weeks|Last observed value during the 8-week treatment period was used in the FAS.|||Percent Change||95% Confidence Interval|Least Squares Mean
1257689|NCT00449956|Primary|Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks|Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)|8 weeks|Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS).|||mmHg||95% Confidence Interval|Least Squares Mean
1257690|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1257691|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1257692|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1257693|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1257694|NCT00449930|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 24 weeks|The per protocol population required that a patient had measurements both at baseline and at Week 24, and did not have any major protocol violations (e.g. drug compliance <85%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.|||Percent||95% Confidence Interval|Least Squares Mean
1257695|NCT00449865|Primary|The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson’s Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.|All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).|Change from baseline to 5 YEARS|Intent-to-Treat sample: n = 955, participants randomized at least 5 years before July 2013 (time of planned interim analysis).|||summed-ranks||95% Confidence Interval|Mean
1258277|NCT00445211|Secondary|Hospital Death During the Index Hospitalization||0-4 post surgery||||Participants|||Count of Participants
1257697|NCT00449787|Secondary|Headache-related Functional Disability|This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment.|Baseline, two hours|Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here.|||participants|||Number
1257698|NCT00449787|Primary|Numerical Rating Scale|"Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable.~Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief"|Baseline, two hours|After discharge from the emergency room, some patients had headache requiring use of medication and some did not. Only those patients who took the investigational medication were included in the analysis|||units on a scale||Standard Deviation|Mean
1257699|NCT00449748|Primary|Number of Participants With Objective Response|Efficacy reported as objective response. Objective response defined as change in serum tryptase level or bone marrow mast cell percentage.|Monthly for first 3 months, then every 3 months|Analysis was per protocol.|||Participants|||Number
1257700|NCT00449696|Secondary|Acetaminophen Consumption|Weekly mean acetaminophen consumption between weeks 9 and 13.|Weeks 9 to 13 (5 weeks)|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||milligrams||Standard Deviation|Mean
1257701|NCT00449696|Secondary|Change From Baseline in Physician Global Evaluations|Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule.|||scores on a scale||Standard Deviation|Mean
1257702|NCT00449696|Secondary|Change From Baseline in Subject Global Evaluations|Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
1257703|NCT00449696|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore|Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
1257704|NCT00449696|Secondary|Change From Baseline in Short Form - 36 (SF-36)|Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores||Standard Deviation|Mean
1257705|NCT00449696|Secondary|Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response|Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).|Weeks 6 to 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||Percentage|||Number
1257706|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Total Score|Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
1257707|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Physical Function Subscore|Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
1257753|NCT00449033|Secondary|Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population|LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms.|from randomization of the first patient to 38 months later or death whatever occurs first.|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1257708|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Stiffness Subscore|Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
1257709|NCT00449644|Secondary|The Percentage of Participants With Sputum Culture Conversion (Stage 2)|The table below shows the percentage of participants in Stage 2 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.|Week 24, Week 72, and Week 120 (Stage 2)|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Percentage of Participants|||Number
1257710|NCT00449644|Secondary|The Percentage of Participants With Sputum Culture Conversion (Stage 1)|The table below shows the percentage of participants in Stage 1 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.|Week 8, 24, and 104 (Stage 1)|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Percentage of Participants|||Number
1257711|NCT00449644|Secondary|The Time to Sputum Culture Conversion at Week 72 (Stage 2)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 72, Stage 2|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Days||95% Confidence Interval|Median
1257712|NCT00449644|Secondary|The Time to Sputum Culture Conversion at Week 24 (Stage 1)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 24, Stage 1|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Days||95% Confidence Interval|Median
1257713|NCT00449644|Primary|The Time to Sputum Culture Conversion at Week 24 (Stage 2)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 24, Stage 2|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Days||95% Confidence Interval|Median
1257714|NCT00449644|Primary|The Time to Sputum Culture Conversion at Week 8 (Stage 1)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 8, Stage 1|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Days||95% Confidence Interval|Median
1257715|NCT00449540|Secondary|Percentage of Participants Who Have Photophobia|Percentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|2 hours post treatment||||Percentage of participants|||Number
1257716|NCT00449540|Secondary|Percentage of Participants Who Have Symptoms Phonophobia|Percentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|2 hours post treatment||||Percentage of Participants|||Number
1257717|NCT00449540|Secondary|Percentage of Participants Who Have Symptoms of Nausea|Percentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|two hours post treatment||||percentage of participants|||Number
1258278|NCT00445211|Secondary|Intra-aortic Balloon Pump-related Death During the Index Hospitalization||0-4 days post surgery||||Participants|||Count of Participants
1257718|NCT00449540|Primary|Percentage of Participants Experiencing no Pain at Two Hours Post-treatment|Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.|Two hours|Full-analysis set: intention to treat population (201) adjusted for those participants who did not administer treatment during the study period|||percentage of participants|||Number
1257719|NCT00449176|Secondary|Responder Analysis 50% Improvement|"Defined by the proportion of subjects achieving at least 50% improvement from baseline in the primary endpoint of change from baseline of the average pain intensity based on the 11-point Numerical Rating Scale (NRS) at week 12. The subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and Week 12|Intent to Treat Analysis Set|||Percentage of participants|||Number
1257720|NCT00449176|Secondary|Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|Baseline and 12 week endpoint|Intent to Treat Analysis Set, LOCF imputation method. The patients who didi not have any assessment during the treatment period were excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1257721|NCT00449176|Secondary|Number of Participants With Treatment Discontinuation Due to Lack of Efficacy|The number of participants who discontinued due to lack of efficacy from baseline to endpoint|Baseline and 12 weeks|Intent to Treat Analysis Set|||participants|||Number
1257722|NCT00449176|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Ordinal measure indicating change from start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved)|Baseline and 12 week endpoint|Intent to Treat Analysis (ITT) set, Last Observation Carried Forward (LOCF) imputation method. The ITT analysis set included all randomized subjects who took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis.|||percentage of participants|||Number
1257723|NCT00449176|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement."|Baseline and 12 week endpoint|Intent to Treat population with LOCF imputation. The patients who didi not have any assessment during the treatment period were excluded from the analysis.|||hours||Standard Deviation|Mean
1257724|NCT00449176|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.|"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline."|Baseline and 12 week endpoint|Intent to Treat (ITT) analysis set, last observation carried forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1257725|NCT00449176|Primary|Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks|Intent To Treat (ITT) analysis set utilizing Last Observation Carried Forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. 7 patients (3 tapentadol ER, 3 oxycodone CR, 1 placebo) had no baseline pain scores therefore excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1257726|NCT00449163|Secondary|Rate of Toxicity in Study Participants|Evaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.|2 years||||percentage of participants|||Number
1257727|NCT00449163|Secondary|Median Progression-free Survival in Months|Median number of months subjects achieved progression-free survival|2 years||||months||95% Confidence Interval|Median
1257728|NCT00449163|Secondary|Response Rate (Complete Response and Partial Response)|Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0|2 years||||percentage of participants||95% Confidence Interval|Number
1257729|NCT00449163|Primary|Overall Survival up to 2 Years|Percentage of patients with overall survival times of up to 2 years|2 years||||percentage of participants||95% Confidence Interval|Number
1257730|NCT00449150|Secondary|Time Course of Quality of Life|The time course of quality of life: assessed by the following disease specific quality of life:“If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?” The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.|Quality of life assessment in the following weeks: 4,12,26,30,38,46,52||||score on a scale||Standard Deviation|Mean
1257731|NCT00449150|Primary|International Prostate Symptoms Score (IPSS)|The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst)|Baseline and 52 weeks|The Intent-to-treat (ITT) population included all participants for whom at least one post-baseline efficacy assessment was available; imputation per Last Observation Carried Forward (LOCF)|||Units on a scale||Standard Deviation|Mean
1257732|NCT00449072|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|"Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind investigational product (IP) are defined as TEAEs.~A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life-threatening~Required inpatient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was a medically important event"|From Day 1 to 7 days following end of treatment (Day 360)|All randomized and treated participants, excluding those from GCP noncompliant sites.|||participants|||Number
1257733|NCT00449072|Secondary|24 Hour Cortisol/Creatinine Ratio|Urine cortisol and creatinine levels were determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. No normal range is available for cortisol/creatinine ratio.|Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)|All randomized and treated participants, excluding those from GCP noncompliant sites.|||μg/g Creatinine||Standard Deviation|Mean
1257734|NCT00449072|Secondary|24 Hour Urinary Free Cortisol Levels|Urine cortisol levels was determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours].|Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)|All randomized and treated participants, excluding those from GCP noncompliant sites.|||μg/24 hours||Standard Deviation|Mean
1257735|NCT00449072|Secondary|Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study|"Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.~The percentage of days that participants used the rescue medication during the double-blind treatment phase of the study."|double-blind treatment period (Day 1 to Day 360)|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.|||percentage of days||Standard Deviation|Mean
1257736|NCT00449072|Secondary|Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study|"Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.~The percentage of participants who used the rescue medication during each of the study periods is reported."|Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420)|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.|||percentage of participants|||Number
1257737|NCT00449072|Secondary|Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period|"Global efficacy was assessed by the investigator using the following scale:~0 = no relief (symptoms unchanged or worse than before)~1 = slight relief (symptoms were present and only minimally improved)~2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)~3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)~4 = complete relief (virtually no symptom present)"|Day 120, Day 240 and Day 360|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.|||score on a scale||Standard Deviation|Mean
1257738|NCT00449072|Secondary|Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period|"Global efficacy was assessed by the participant (with the help of a parent/guardian/caregiver) using the following scale:~0 = no relief (symptoms unchanged or worse than before)~1 = slight relief (symptoms were present and only minimally improved)~2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)~3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)~4 = complete relief (virtually no symptom present)"|Day 120, Day 240 and Day 360|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.|||score on a scale||Standard Deviation|Mean
1257739|NCT00449072|Secondary|Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment|"PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:~0 = symptom absent~1 = mild (present but not annoying to self)~2 = moderate (annoying to self but not interfering with sleep or daily living)~3 = severe (interfered with daily living and/or sleep)~Individual symptom scores ranged from 0 (best outcome) to 3 (worst outcome). A negative value for change represents an improvement in symptoms."|For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)|mITT population with available nasal symptom scores: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with available nasal symptom scores, excluding those from GCP noncompliant sites.|||score on a scale||Standard Error|Least Squares Mean
1257740|NCT00449072|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS)|"PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:~0 = symptom absent~1 = mild (present but not annoying to self)~2 = moderate (annoying to self but not interfering with sleep or daily living)~3 = severe (interfered with daily living and/or sleep)~TNSS was the sum of the individual symptom scores (ranging 0-3), and TNSS ranged from 0 (best outcome) to 12 (worst outcome). A negative value for change represents an improvement in symptoms."|For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)|mITT population with scores available for TNSS: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with scores available for TNSS, excluding those from GCP noncompliant sites.|||score on a scale||Standard Error|Least Squares Mean
1289129|NCT00135707|Secondary|Hematocrit ≤24% With Transfusion||Delivery admission to discharge||||Participants|||Count of Participants
1257741|NCT00449072|Primary|Growth Velocity|"Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time.~Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing."|Day 1 to end of treatment (Day 360)|The modified intent-to-treat (mITT) population included all intent-to-treat participants who had at least 3 postrandomization visits with recorded height measurements during the double-blind treatment period, excluding those from Good Clinical Practice (GCP) noncompliant sites.|||cm/year||Standard Error|Least Squares Mean
1257742|NCT00449046|Secondary|Number of Participants With Rescue Medication-Free Nights and Days|Rescue free means without the use of other medication.|Baseline and Week 24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||Participants|||Number
1257743|NCT00449046|Secondary|Number of Participants With Symptom-Free Nights and Days||Baseline and Week 24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||Participants|||Number
1257744|NCT00449046|Secondary|Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24|"Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||Percent Change||Standard Deviation|Mean
1257745|NCT00449046|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24|"The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||L/min||Standard Deviation|Mean
1257746|NCT00449046|Secondary|Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24|Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||Percent Change||Standard Deviation|Mean
1257747|NCT00449046|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24|"PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||L/min||Standard Deviation|Mean
1257748|NCT00449046|Primary|Serious Adverse Events (SAEs) - On Therapy|"Number of participants considered by the investigator to be related to study medication.~Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)"|Baseline to Week 24|Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication.|||Participants|||Number
1257749|NCT00449046|Primary|Most Frequent Adverse Events - On Therapy|Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.|Baseline to Week 24|Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication|||Participants|||Number
1257750|NCT00449033|Secondary|EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population|The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).|from randomization of the first patient until 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1257751|NCT00449033|Secondary|Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states.|from randomization of the first patient until 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1257752|NCT00449033|Secondary|Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population|TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed.|from randomization of the first patient to 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||months||95% Confidence Interval|Median
1258471|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1257754|NCT00449033|Secondary|Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population|The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL.|from randomization of the first patient until 38 months|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1257755|NCT00449033|Secondary|Time to Response (TTR) in the ITT (Non-squamous) Population|TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of TTR based on ITT (non-squamous) population. No statistical testing performed.|||days||95% Confidence Interval|Median
1257756|NCT00449033|Secondary|Duration of Stable Disease (SD) in the ITT (Non-squamous) Population|Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of duration of stable disease based on ITT (non-squamous) population. No statistical testing performed.|||days||95% Confidence Interval|Median
1257757|NCT00449033|Secondary|Duration of Response in the ITT (Non-squamous) Population|Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of duration of response based on ITT (non-squamous) population. No statistical testing performed.|||days||95% Confidence Interval|Median
1257758|NCT00449033|Secondary|Disease Control (DC) in the ITT (Non-squamous) Population|DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of Disease Control based on ITT (non-squamous) population.|||percentage of participants|||Number
1257759|NCT00449033|Secondary|Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population|Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of Tumour Response based on ITT (non-squamous) population.|||percentage of participants|||Number
1257760|NCT00449033|Secondary|Time to Progression (TTP) in the ITT (Non-squamous) Population|TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of TTP based on ITT (non-squamous) population. TTP for patients with no tumour assessments after baseline was censored at one day.|||days||95% Confidence Interval|Median
1257761|NCT00449033|Secondary|Progression-free Survival (PFS) in the ITT (Non-squamous) Population|PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of PFS based on ITT (non-squamous) population. PFS for patients with no tumour assessments after baseline was censored at one day.|||days||95% Confidence Interval|Median
1257762|NCT00449033|Secondary|OS in the ITT (Squamous) Population|OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. No statistical testing performed.|||days||95% Confidence Interval|Median
1257791|NCT00448682|Secondary|Number of Participants Experiencing Adverse Events|Number of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.|1 year|The study data has not been analyzed.||||||
1257763|NCT00449033|Secondary|OS in the ITT (Both Squamous and Non-squamous) Population|OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (both non-squamous and squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.|||days||95% Confidence Interval|Median
1257764|NCT00449033|Primary|Overall Survival (OS) in the ITT (Non-squamous) Population|Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (non-squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.|||days||95% Confidence Interval|Median
1257765|NCT00448916|Secondary|Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257766|NCT00448916|Secondary|Seizure Frequency.|Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE.|28 Days|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257767|NCT00448916|Secondary|Number of Participants With Abnormalities in Creatine Kinase.|Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257768|NCT00448916|Secondary|Number of Participants With Abnormalities in Endocrine Panel (Hormones).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257769|NCT00448916|Secondary|Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257770|NCT00448916|Secondary|Number of Participants With Hematotolgical Abnormalities.|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257771|NCT00448916|Secondary|Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).|"Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated.~Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below."|Week 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257772|NCT00448916|Secondary|Height at Month 12/Early Termination.|Height was recorded in centimeters.|Month 12/Early Termination|Safety analysis set: All participants who received at least one dose of study medication were included.|||cm||Standard Deviation|Mean
1257773|NCT00448916|Secondary|Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.|Weight was recorded in kilograms and weight change from Baseline was reported.|Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up|Safety analysis set: All participants who received at least one dose of study medication were included.|||Kg||Standard Deviation|Mean
1257774|NCT00448916|Secondary|Derived Body Mass Index Data (BMI) at Month 12/Early Termination.|BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.|Month 12/Early Termination|Safety analysis set: All participants who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 participants in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively.|||Kg/m^2||Standard Deviation|Mean
1257775|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).|Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257838|NCT00448279|Secondary|Overall Survival - Time to Event|The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.|BL and every 8 weeks thereafter|ITT population|||months||95% Confidence Interval|Median
1257776|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).|Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257777|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).|Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257778|NCT00448916|Secondary|Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined.|Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257779|NCT00448916|Secondary|Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|"Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as abnormal and no abnormalities in the sites were reported as normal. Any change from the previous physical examination results were noted."|Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257780|NCT00448916|Primary|Number of Participants With Adverse Events (AE).|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
1257781|NCT00448864|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve|Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L)|1, 2, 4, and 8 hours after end of study drug infusion|All participants who received at least 1 dose of study drug.|||mg*h/L||Standard Deviation|Mean
1257782|NCT00448864|Secondary|Number of Participants With Treatment-emergent Adverse Events|A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|up to 28 days post admission to ICU|All participants who received at least 1 dose of study drug.|||participants|||Number
1257783|NCT00448864|Secondary|Cumulative Chest Tube Drainage at 24 Hours Postoperatively|Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.|Up to 24 hours post admission to ICU|All participants who received at least 1 dose of study drug.|||Milliliters||Standard Deviation|Mean
1257784|NCT00448864|Primary|Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively|Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.|Up to 12 hours post admission to intensive care unit (ICU)|All participants who received at least 1 dose of study drug.|||Milliliters||Standard Deviation|Mean
1257785|NCT00448760|Secondary|Overall Survival||24 months||||months||95% Confidence Interval|Median
1257786|NCT00448760|Secondary|Median Progression-free Survival (PFS)||24 months||||months||95% Confidence Interval|Median
1257787|NCT00448760|Secondary|Clinical Response|"Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest:~Complete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values.~Partial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions."|8 - 16 weeks||||percentage of participants||90% Confidence Interval|Number
1257788|NCT00448760|Primary|Pathologic Complete Response|No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.|8 - 16 weeks||||percentage of participants||90% Confidence Interval|Number
1257789|NCT00448708|Secondary|Adverse Events|adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review.|1 year||||participants|||Number
1257790|NCT00448708|Primary|Time-to-loss of Target Site Primary Patency|"Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the time-to-loss of primary patency. Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol."|1 year||||days||95% Confidence Interval|Median
1258578|NCT00443053|Secondary|Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77|The number of participants requiring surgery was measured.|Days 47 and 77|ITT Population|||participants|||Number
1257792|NCT00448682|Secondary|Overall Rate of Survival|Patients will be followed for overall survival from date of enrollment to date of death or last contact. The extent of follow up will be described by the range and median for deceased patients and for those alive at last follow up. We will estimate the 1 year survival rates by the Kaplan-Meier method.|1 year|The study data has not been analyzed.||||||
1257793|NCT00448682|Primary|Number of Patients Achieving Clinical Response|Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.|1 year|The study data has not been analyzed.||||||
1257794|NCT00448630|Secondary|Metabolic Syndrome Parameter Triglycerides by Treatment Group|Iterative measurement of triglycerides. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
1257795|NCT00448630|Secondary|Metabolic Syndrome Parameter Waist Circumference by Treatment Group|Iterative measurement of waist circumference. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||cm (centimeter)||Standard Deviation|Mean
1257796|NCT00448630|Secondary|Metabolic Syndrome Parameter Weight by Treatment Group|Iterative measurement of weight. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||kg||Standard Deviation|Mean
1257797|NCT00448630|Primary|Metabolic Syndrome Parameter Triglycerides|Iterative measurement of triglycerides. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
1257798|NCT00448630|Primary|Metabolic Syndrome Parameter High Density Lipoprotein (HDL)|Iterative measurement of HDL. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
1257799|NCT00448630|Primary|Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)|Iterative measurement of LDL. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
1257800|NCT00448630|Primary|Metabolic Syndrome Parameter Total Cholesterol|Iterative measurement of total cholesterol. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
1257801|NCT00448630|Primary|Metabolic Syndrome Parameter Fasting Blood Sugar|Iterative measurement of fasting blood sugar. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl (miligrams per deciliter)||Standard Deviation|Mean
1257802|NCT00448630|Primary|Metabolic Syndrome Parameter Waist Circumference|Iterative measurement of waist circumference. Mean at timepoints.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||cm (centimeter)||Standard Deviation|Mean
1257803|NCT00448630|Primary|Metabolic Syndrome Parameter Body Weight|Iterative measurement of body weight. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||kg (kilogram)||Standard Deviation|Mean
1257804|NCT00448630|Secondary|Metabolic Syndrome Parameter BMI by Treatment Group|Iterative measurement of BMI. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||kg/m*m||Standard Deviation|Mean
1257805|NCT00448630|Primary|Metabolic Syndrome Parameter Body Mass Index (BMI)|Iterative mean Body Mass Index at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||kg/m*m (kilograms per meter squared)||Standard Deviation|Mean
1257806|NCT00448591|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)|Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.|Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion|Safety Population|||percentage of participants|||Number
1257807|NCT00448591|Secondary|Percentage of Participants by Best Overall Response to Treatment|Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population|||percentage of participants|||Number
1257808|NCT00448591|Secondary|Overall Survival|Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.|Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months|ITT Population|||months||Full Range|Median
1257809|NCT00448591|Secondary|Percentage of Participants With Recorded Death||Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population|||percentage of participants|||Number
1257810|NCT00448591|Secondary|Time to Progression (TTP)|TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population|||months||Full Range|Median
1257811|NCT00448591|Secondary|Percentage of Participants With Disease Progression|Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population|||percentage of participants|||Number
1289130|NCT00135707|Secondary|Postpartum Pulmonary Edema||After delivery through discharge||||Participants|||Count of Participants
1257812|NCT00448539|Primary|Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase|"Seizure data was collected via patient diaries. OL refers to open-label."|Baseline, Titration Phase (Days 1 to 18), Maintenance Phase|Intent-to-treat (ITT) population: All subjects who completed titration to open-label medication|||Percentage change||Full Range|Median
1257813|NCT00448448|Primary|Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)||Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.|The primary analysis included all patients who had completed the trial by January 2013, including 116 patients from the randomized arm and 126 from the preference arm.|||percentage of patient successes|||Number
1257814|NCT00448435|Secondary|Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment|Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of participants|||Number
1257815|NCT00448435|Secondary|Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment|Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of participants|||Number
1257816|NCT00448435|Secondary|Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of circadian variation||Standard Deviation|Mean
1257817|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||L/Min||Standard Deviation|Mean
1257818|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of personal best value||Standard Deviation|Mean
1257819|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of predicted value||Standard Deviation|Mean
1257820|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||L/min||Standard Deviation|Mean
1257821|NCT00448435|Secondary|Percentage of Subjects With Rescue Medication-Free Nights and Days|Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment|Crossover Period Weeks 1-4, 7-10|PPS|||Percentage of participants|||Number
1257822|NCT00448435|Secondary|Percentage of Subjects With Symptom-Free Nights & Days|Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment|Crossover Period Week 1-4, 7-10|PPS|||Percent of participants|||Number
1257823|NCT00448435|Secondary|Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period Weeks 1-4, 7-10|PPS|||Percentage of circadian variation||Standard Error|Mean
1257824|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period weeks 1-4, 7-10|PPS|||L/min||Standard Error|Mean
1257825|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period weeks 1-4, 7-10|PPS|||Percentage of personal best value||Standard Error|Mean
1257826|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period Weeks 1-4, 7-10|PPS|||Percentage of predicted value||Standard Error|Mean
1257839|NCT00448279|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.|BL and every 8 weeks thereafter|ITT population|||percentage of participants|||Number
1257827|NCT00448435|Primary|Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).|Crossover Period Weeks 1-4, and 7-10|PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.|||Liters/minute||Standard Error|Mean
1257828|NCT00448357|Secondary|Overall Survival|Percentage of participants alive at 3 years post transplant|Three years post-transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.|||percentage of participants|||Number
1257829|NCT00448357|Secondary|Incidence of DNA Chimerism in Patients Between One Month Post Transplant|Deoxyribonucleic acid (DNA) chimerism is a measure identifying the genetic profiles of the transplant recipient and of the donor and then evaluating the extent of mixture in the recipient’s blood, bone marrow, or other tissue.|30 days post transplant|Because there were no differences in chimerism results as a function of either the immunosuppression used or busulfan dose received, the results are being reported only for the total population.|||Participants|||Count of Participants
1257830|NCT00448357|Secondary|Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant|"GVHD can be mild, moderate or severe depending on the differences in tissue type between patient and donor. GVHD can be acute or chronic. Its symptoms can include:~Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body~Blistering, causing the exposed skin surface to flake off in severe cases~Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected~Jaundice, or a yellowing of the skin, which can indicate liver damage~Excessive dryness of the mouth and throat, leading to ulcers~Dryness of the lungs, vagina and other surfaces"|100 days post transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.|||Participants|||Count of Participants
1257831|NCT00448357|Secondary|Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen|Test doses of busulfan were administered and plasma levels were measured to determine a targeted AUC dosing estimate. The capacity is reported as the precision with which these test dose goals predicted the actual 90-hour mean AUC levels.Dose targeting precision was estimated by root mean squared error.|Day -15 to Day -11||||percentage of error|||Number
1257832|NCT00448357|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Dose limiting toxicity will be defined as any irreversible grade 3 or any grade 4 non-hematologic toxicity that is related to busulfan infusion and not graft vs host disease or late infection after recovery from the initial period of myelosuppression. The maximum tolerated dose (MTD) is defined as the dose with probability of dose limiting toxicity (DLT) of 0.25. The dose of continuous infusion IV busulfan based on blood levels derived from a test dose in conjunction with fludarabine and alemtuzumab plus tacrolimus for GVHD prophylaxis.|first 6 weeks or 42 days following stem cell infusion||||DLTs|||Number
1257833|NCT00448357|Primary|Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912)|Relapse is defined as new or increased sites of disease or positive one marrow after a complete response (CR). The RFS was calculated as the percentage of patients who were alive and without relapse at 3 years|Three years post-transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.|||percentage of participants|||Number
1257834|NCT00448344|Secondary|The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up|self-reported 7- day point prevalent abstinence|12-months follow-up||||percentage of participants that quit|||Number
1257835|NCT00448344|Primary|The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention|self-reported 7-day point prevalent abstinence|5 months||||percentage of participants that quit|||Number
1257836|NCT00448279|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|BL and every 8 weeks thereafter|ITT population|||percentage of participants||95% Confidence Interval|Number
1257837|NCT00448279|Secondary|Percentage of Participants by Best Overall Response (BOR)|BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|BL and every 8 weeks thereafter|ITT population|||percentage of participants|||Number
1266511|NCT00386360|Secondary|Lumbar Spine BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1257841|NCT00448279|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.|Baseline (BL) and every 8 weeks thereafter|ITT population|||percentage of participants|||Number
1257842|NCT00448227|Secondary|Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel|"Assessed by the study personnel using a 5-point scale after dosing:~Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation~Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose~Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose~Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose~Very well accepted: infant appeared eager and ingested most of dose without special coaxing"|Immediately after dosing|Safety population.|||Participants|||Number
1257843|NCT00448227|Primary|Pharmacokinetics of Single Dose - AUC(0-6h)|Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.|||(μg/mL)•h||Standard Deviation|Mean
1257844|NCT00448227|Primary|Pharmacokinetics of Single Dose - AUC(0-tlast)|Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.|||(μg/mL)•h||Standard Deviation|Mean
1257845|NCT00448227|Primary|Pharmacokinetics of Single Dose - Cmax|Measured by Cmax - The maximum plasma concentration of study medication|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.|||μg/mL||Standard Deviation|Mean
1257846|NCT00448227|Secondary|Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver|"Assessed by the caregiver using a 5-point scale immediately after dosing:~Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation~Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose~Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose~Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose~Very well accepted: infant appeared eager and ingested most of dose without special coaxing"|Immediately after dosing|Safety population.|||Participants|||Number
1257847|NCT00448227|Secondary|Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.|"Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:~Significant emesis occurred,~Infant spit out most of the dose ingesting less than half of what was administered,~Infant spit out some of the dose, but ingested at least 50% of what was administered,~Infant was able to ingest and retain the dose administered"|30 minutes after dosing|Safety population.|||Participants|||Number
1257848|NCT00448227|Secondary|Safety Assessed by Labs|Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.|2 days|||||||
1257849|NCT00448227|Secondary|Safety Assessed by AEs, SAEs|AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.|38 days|||||||
1257850|NCT00448227|Primary|Pharmacokinetics of Single Dose - Tmax|Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.|||hours||Full Range|Median
1257851|NCT00448201|Secondary|Graft-vs-host Disease at 6 Months Post-transplant|"Graft-vs-host disease (GVHD) can be mild, moderate or severe depending on the differences in tissue type between patient and donor. Its symptoms can include:~Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body~Blistering, causing the exposed skin surface to flake off in severe cases~Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected~Jaundice, or a yellowing of the skin, which can indicate liver damage~Excessive dryness of the mouth and throat, leading to ulcers~Dryness of the lungs, vagina and other surfaces~Acute GVHD - Can occur soon after the transplanted cells begin to appear in the recipient. Acute GVHD ranges from mild, moderate or severe, and can be life-threatening if its effects are not controlled.~Extensive chronic GVHD - Usually occurs at about three months post-transplant."|6 Months||||percentage of participants|||Number
1257852|NCT00448201|Secondary|5-year Disease-free Survival|The length of time post-transplant that the patient survives without any signs or symptoms of that cancer.|Year 5||||percentage of participants|||Number
1257853|NCT00448201|Secondary|Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant|"Complete chimerism is defined as 100% donor cells detected, suggesting complete hematopoietic replacement. Mixed donor chimerism means host cells are detected in particular cells like lymphocytes. Five to 90% donor cells set the criteria for mixed chimerism (MC).~Chimerism was not tabulated on day 30."|Days 30, 60, and 90||||percentage of patients|||Number
1257854|NCT00448201|Secondary|Complete Response at 6 and 12 Months Post-transplant||6 and 12 months|Complete response was not calculated at 6 and 12 months because the majority of patients had complete response at the time of transplant.||||||
1257855|NCT00448201|Primary|Treatment-related Mortality|Treatment related mortality for first 6 months. Defined as the number of treatment related deaths excluding deaths due to disease relapse.|6 months||||percentage of participants|||Number
1257856|NCT00448175|Secondary|Known Side Effects Through 12 Weeks||12 weeks|||||||
1257860|NCT00448175|Primary|Frequency of Voids at 12 Weeks|To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.|Baseline to 12 weeks||||Voids/day||Standard Deviation|Mean
1257861|NCT00448136|Secondary|EORTC QLQ-C30 Functional and Symptom Scale Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1257862|NCT00448136|Secondary|Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Changes from baseline were categorized as follows: Very much worsening (less than [<]-20); Moderate worsening (greater than or equal to [≥]-20 to <-10); Little worsening (≥-10 to <-5); No change (≥-5 to less than or equal to [≤]5); Little improvement (>5 to ≤10); Moderate improvement (>10 to ≤20); and Very much improved (>20).|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1257863|NCT00448136|Secondary|Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. Number (n) equals (=) the number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1257864|NCT00448136|Secondary|OS - Percentage of Participants Surviving at 12 and 24 Months|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population.|||percentage of participants|||Number
1257865|NCT00448136|Secondary|OS - Time to Event|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit. Median OS was estimated using the Kaplan-Meier method.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population|||months||95% Confidence Interval|Median
1257866|NCT00448136|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
1257867|NCT00448136|Secondary|Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months|Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.|||percentage of participants|||Number
1257868|NCT00448136|Secondary|Duration of ODC - Time to Event|Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median time to event was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.|||months||95% Confidence Interval|Median
1257878|NCT00448123|Secondary|Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge||1-7 days|The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information regarding pain medication at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided the pain medication information at the Day 7 interview. At Day 7 each group had only 3 non-zero responses.|||Pain tablets||Full Range|Mean
1257869|NCT00448136|Secondary|Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event|Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
1257870|NCT00448136|Secondary|Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months|Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
1257871|NCT00448136|Secondary|Duration of OR - Time to Event|Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median duration of OR was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
1257872|NCT00448136|Primary|PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
1257873|NCT00448136|Primary|PFS - Time to Event|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||months||95% Confidence Interval|Median
1257874|NCT00448136|Secondary|Duration of Overall Response (OR) - Percentage of Participants With an Event|Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response of CR or PR were included in the analysis.|||percentage of participants|||Number
1257875|NCT00448136|Secondary|Percentage of Participants With a Response by Best Overall Response|Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population. Data were missing from centralized review for 1 participant.|||percentage of participants||95% Confidence Interval|Number
1257876|NCT00448136|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
1257877|NCT00448123|Secondary|High Pain Score by Treatment Group|Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.|7 Days|The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided information at the Day 7 interview.|||units on a scale||Full Range|Mean
1257879|NCT00448123|Primary|Stone Passage|Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.|1-7 days|In the placebo group, of the 47 subjects 18 (46.2%) passed their stone by Day 7. In the Tamsulosin group, of the 53 subjects 21 (53.9%) passed their stone by Day 7.|||participants|||Number
1257880|NCT00448019|Secondary|Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL|ORR defined as CR and PR response where response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).|Response assessed after three 4-week courses and after six courses, up to 24 weeks|Five participants of the 62 treated participants were not evaluable for response.|||percentage of participants|||Number
1257881|NCT00448019|Secondary|Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)|Response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).|Response assessed after three 4-week courses and after six courses, up to 24 weeks|Five participants of the 62 treated participants were not evaluable for response.|||participants|||Number
1257882|NCT00448019|Primary|Progression Free Survival (PFS) Rate|Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Baseline up to 5 years|Five participants of the 62 treated participants were not evaluable for response.|||Months||Full Range|Median
1257883|NCT00447902|Primary|The Primary Safety Endpoint Was the Occurrence of Dose-limiting Hepatotoxicity During the Study.|Dose-limiting hepatotoxicity was defined as Grade 4 ALT or AST elevation confirmed in 48h or any evocative symptoms or signs of hepatitis, if it not clearly attributable to another cause. Patients who experienced dose-limiting hepatotoxicity stopped TPV/r and were considered treatment failures for the analysis.|From the start of the study through 48 weeks.|||||||
1257884|NCT00447902|Secondary|Frequency of Patients (%) With Possible Clinically Significant Abnormalities of Laboratory Measurements|Frequency of patients (%) with possible clinically significant abnormalities of laboratory measurements (haematology, differentials (automatic and absolute), coagulation, electrolytes, enzymes, substrates, urinalysis, serology and T-cells)|Baseline through 48 weeks||||percentage of participants|||Number
1257885|NCT00447902|Secondary|Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4|Post-dose Tipranavir (TPV) and Ritonavir (RTV) plasma concentrations at Week 4|Week 4|The trial has been stopped due to a poor enrollment||||||
1257886|NCT00447902|Secondary|Occurrence of Tipranavir (TPV) Trough Concentration >120 μM|Patients with TPV trough above 120 μM are at high risk of developing a Grade 3 or 4 ALT or AST elevations. The risk of Grade 3 or greater transaminase elevations appeared to be uniform at TPV trough concentration below 120 μM. Hence, for this study the TPV trough should be maintained below 120 μM.|After 2 weeks of treatment until the end of trial|The trial has been stopped due to a poor enrollment||||||
1257887|NCT00447902|Secondary|Occurrence of Tipranavir (TPV) Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured|A high inhibitory quotient (IQ), the ratio of trough plasma drug concentration to the protein-adjusted viral IC50, is a useful indicator of the potential efficacy margin of antiretroviral drugs. The IQ for TPV is calculated by the formula IQ = TPV Ctrough / (3.75 x Z x fold change of the patients virus), where Z = wild type control IC50 IIIB.|After 2 weeks of treatment until the end of trial|The trial has been stopped due to a poor enrollment||||||
1257888|NCT00447902|Secondary|Patients Adherence With Study Medication Based on Pill Count|number of pills actually taken divided by the planned number of pills the patient should take|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
1257889|NCT00447902|Secondary|Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|Tipranavir (TPV) and Ritonavir (RTV) trough concentrations from plasma samples at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment||||||
1257890|NCT00447902|Secondary|Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.|Change from baseline to Week 48 for the ratio of CD3+ CD8+ CD38+ HLA DR . Samples were obtained for CD3+ CD8+ CD38+ HLA DR as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment||||||
1257891|NCT00447902|Secondary|Change in Ratio of CD38+/CD8+ From Baseline to Week 48|Change from baseline to Week 48 for the ratio of CD38+ to CD8+ cell counts. Samples were obtained for CD38+ and CD8+ as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment||||||
1257892|NCT00447902|Secondary|Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48|Change from baseline to Week 48 for CD4+ and CD8+ cell counts. Samples were obtained for CD4+ and CD8+ as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment||||||
1271040|NCT00352053|Secondary|Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count||Baseline to 24 weeks|ITT Analysis Set, missing = excluded method|||cells/mm3||Inter-Quartile Range|Median
1257894|NCT00447902|Secondary|Time to Treatment Failure|For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.|After Day 1 of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
1257895|NCT00447902|Secondary|Change in Viral Load From Baseline at Each Visit|Change in viral load (measured from a plasma sample) from baseline at each visitPatients with a viral load of less than 400 copies/mL at each visit as .|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
1257896|NCT00447902|Secondary|Occurrence of ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48|Occurrence of greater than or equal to 1 log10 drop in viral load from baseline at all visits, including visits at Weeks 24 and 48|Baseline, 24 and 48 weeks|The trial has been stopped due to a poor enrollment||||||
1257897|NCT00447902|Secondary|Occurrence of Viral Load Less Than 400 Copies/mL at Each Visit|Patients with a viral load of less than 400 copies/mL at each visit as measured from a plasma sample.|After 4 weeks of treatment until the end of the trial|||||||
1257898|NCT00447902|Secondary|Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48|Patients with a viral load of less than 400 copies/mL at Weeks 24 and 48 as measured from a plasma sample.|24 and 48 weeks|The trial has been stopped due to a poor enrollment||||||
1257899|NCT00447902|Secondary|Virologic Response Defined as Viral Load <50 Copies/mL at Each Visit|Virologic response defined as viral load less than 50 copies/mL|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
1257900|NCT00447902|Primary|Treatment Response at Week 48|Treatment response is a confirmed virologic response, defined as a viral load less than 50 copies/mL at two consecutive measurements at least 5 days apart, without death, permanent discontinuation, or introduction of a new antiretroviral|48 weeks|The trial has been stopped due to a poor enrollment||||||
1257901|NCT00447876|Secondary|Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit|A global assessment of the patient's current condition relative to baseline was performed by the patient at each visit using a 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint.|||Number of participants|||Number
1257902|NCT00447876|Secondary|Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit|A global assessment of the patient's current condition relative to baseline was performed by the Investigator at each visit using 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint.|||Number of participants|||Number
1257903|NCT00447876|Secondary|Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18|Dorsal extension and plantar flexion of the affected foot were assessed at baseline and at Week 18. A ROM of approximately 70 degrees is considered to be normal. The LS means, adjusted for the baseline value are reported.|Baseline and Week 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable was only analyzed for 34 patients (18 for Dysport® and 16 for Placebo) for whom ROM was determined at both baseline and Week 18.|||Degrees||95% Confidence Interval|Least Squares Mean
1257904|NCT00447876|Secondary|Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study|Assessments of the pressure threshold using an algometer (which corresponded to the minimum pressure causing pain) were performed at each visit. Pressure threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pressure threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pressure threshold are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||(kg / cm^2) * day||95% Confidence Interval|Least Squares Mean
1257905|NCT00447876|Secondary|Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit|Pressure pain in the medial back foot was measured using an algometer. Pressure threshold corresponded to the minimum pressure causing pain. The changes from baseline, expressed as pressure threshold differences at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||kg / cm^2||Standard Deviation|Mean
1257906|NCT00447876|Secondary|Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study|Assessments of the pain threshold using an algometer (which was the pressure corresponding to the maximum tolerated pain) were performed at each visit. Pain threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pain threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pain threshold are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||(kg / cm^2) * day||95% Confidence Interval|Least Squares Mean
1275933|NCT00307489|Secondary|Percentage of Participants With Normal ALT at Week 48|ULN for males = 43 U/L; 34 U/L for females|48 Weeks|RAT Analysis Set Non-Completers=Failure|||percentage of participants|||Number
1257907|NCT00447876|Secondary|Changes From Baseline in Pain Threshold at Each Visit|The maximum pain felt in the medial back foot was measured using an algometer. The pain threshold corresponded to the maximum pressure at which pain was still tolerated. Changes from baseline, expressed as pain threshold differences at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||Kilogram (kg) / cm^2||Standard Deviation|Mean
1257908|NCT00447876|Secondary|Assessment of SPID for Continuous Pain for Overall Study|Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of PID as a function of time (i.e. SPID). The LS means for SPID, adjusted for the baseline value of pain at rest are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||cm * day||95% Confidence Interval|Least Squares Mean
1257909|NCT00447876|Secondary|Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit|Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as PID values at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||cm||Standard Deviation|Mean
1257910|NCT00447876|Secondary|Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study|Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the area under the curve (AUC) of PID as a function of time (i.e. SPID). The least square (LS) means of SPID, adjusted for the baseline value of pain while moving are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||cm * day||95% Confidence Interval|Least Squares Mean
1257911|NCT00447876|Secondary|Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit|Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as Pain Intensity Difference (PID) values at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||Centimeter (cm)||Standard Deviation|Mean
1257912|NCT00447876|Secondary|Changes From Baseline in Gerbershagen’s Score at Week 18|The Gerbershagen scale gives a global score ranging between I and III, with lower scores reflecting less impact of pain in terms of temporal, spatial aspects, drug taking behaviour and utilization of the health care system. The changes in Gerbershagen’s global scores from baseline to Week 18 are reported as percentage of patients for each of the specified categories.|Baseline and Week 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable could only be analyzed for 30 patients (15 from each group) for whom the score could be determined both at baseline and at Week 18.|||Percentage of participants|||Number
1257913|NCT00447876|Primary|Responders Rate at Week 6 (Pain While Moving)|The responder rate was defined as the percentage of patients whose pain score while moving during the last 48 hours, measured by means of a 10 cm Visual Analogue Scale (VAS, 0 = no pain, 10 = maximum pain) decreased by at least 50% at Week 6 as compared to baseline. Pain at movement is the cardinal symptom of plantar fasciitis and the 10 cm VAS is a reference method for the assessment of pain intensity.|Baseline and Week 6|The Intention-To-Treat (ITT) analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least once at a later timepoint. Missing values were replaced using the last observation carried forward (LOCF) method.|||Percentage of participants|||Number
1257914|NCT00447772|Secondary|Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)|"At Visit 2 (Week 4) and Visit 3 (Week 12) investigators and patients assessed global efficacy of injection of 500 U Dysport® according to the following response categories:~= very good~= good~= moderate~= insufficient~The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented."|Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||Participants|||Number
1257915|NCT00447772|Secondary|Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)|"Global pain was assessed at Visit 2 (Week 4) and Visit 3 (Week 12); investigators and patients assessed change in global pain according to the following response categories:~= no pain (anymore)~= less pain~= no change~= more pain~The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented."|Week 4 visit and Week 12 visit|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||Participants|||Number
1257936|NCT00447499|Secondary|Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.|Blood samples taken before and 60 and 120 min after glucose load from fasting patient.|24 Weeks|Patients switched directly from octreotide who had GH level measured at the end of study.|||Percent of Participants|||Number
1257916|NCT00447772|Secondary|Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question).~The following categorical changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented: Improvement, No change and Deterioration."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||percentage of patients|||Number
1257917|NCT00447772|Secondary|Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question).~The mean changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||units on a scale||Standard Deviation|Mean
1257918|NCT00447772|Secondary|Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The CDQ-24 is a disease-specific quality of life (QoL) instrument and was assessed at Visits 1 to 3. It consists of 24 items investigating problems in daily living skills related to CD.~This instrument is based on 5 subscales: Stigma, Emotional well-being, Pain, Activities of daily living (ADL), Social/family life to which a number of the 24 items are assigned. There are five possible answers to each item representing increasing severity of impairment (scores 0 to 4). The total scores ranged from 0 to 96 (best to worst QoL). In order to obtain scores of the individual subscales, the total score of each subscale (sum of the individual item scores) was transformed linearly to a 0 to 100 scale (best to worst QoL).~The mean changes in the CDQ-24 total score between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||units on a scale||Standard Deviation|Mean
1257919|NCT00447772|Secondary|Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:~Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0–9 points)~Subscore B: duration of movement (values 1 or 2)~Subscore C: severity and duration of shoulder elevation (range: 0–3 points)~Subscore D: severity and duration of tremor (range: 0–4 points).~A higher score for each subscale represents severe CD symptoms. The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.~The mean changes in the subscores A to D of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||units on a scale||Standard Deviation|Mean
1257920|NCT00447772|Secondary|Change in the Total Score of the Tsui Rating Scale (Patient Walking) Between Baseline (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:~Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0–9 points)~Subscore B: duration of movement (values 1 or 2)~Subscore C: severity and duration of shoulder elevation (range: 0–3 points)~Subscore D: severity and duration of tremor (range: 0–4 points).~The total score was calculated as follows: total score = subscores (A x B) + C + D.~The total score ranges between 0 and 25 points. A high total score represents severe CD.~The mean changes in the total score of the Tsui rating scale (patient walking) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||units on a scale||Standard Deviation|Mean
1257921|NCT00447772|Secondary|Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12)|"The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:~Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0–9 points)~Subscore B: duration of movement (values 1 or 2)~Subscore C: severity and duration of shoulder elevation (range: 0–3 points)~Subscore D: severity and duration of tremor (range: 0–4 points).~The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.~The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 12 visit is presented."|Baseline to Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for the Week 12 visit are reported.|||units on a scale||Standard Deviation|Mean
1257937|NCT00447499|Secondary|Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study|Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.|24 weeks|Patients switched directly from octreotide who had IGF-1 level measured at the end of study.|||Percent of Participants|||Number
1275934|NCT00307489|Primary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48||48 Weeks|RAT Analysis Set Non-Completers=Failure|||percentage of participants|||Number
1257922|NCT00447772|Primary|Change From Baseline in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) at the First On-treatment Visit (Week 4 or Week 12)|"The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:~Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0–9 points)~Subscore B: duration of movement (values 1 or 2)~Subscore C: severity and duration of shoulder elevation (range: 0–3 points)~Subscore D: severity and duration of tremor (range: 0–4 points).~The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.~The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the first on-treatment visit (Week 4 or Week 12 visit) is presented."|Baseline to Week 4 or Week 12 (up to 12 weeks)|The Intention to Treat (ITT) Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale.|||units on a scale||Standard Deviation|Mean
1257923|NCT00447603|Secondary|Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period||Baseline and Week 4|Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.||||||
1257924|NCT00447603|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study||up to 4 weeks|All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.||||||
1257925|NCT00447603|Primary|Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study||up to 4 weeks|All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.||||||
1257926|NCT00447603|Primary|Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period||Baseline and Week 4|Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.||||||
1257927|NCT00447590|Secondary|Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire|Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years.|Baseline to 5 Years|Participants who completed the IWQOL Kids questionnaire through month 60 (year 5).|||units on IWQOL Kids scale||95% Confidence Interval|Mean
1257928|NCT00447590|Secondary|Change in Quality of Life Using the Beck Depression Inventory II (BDI)|Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years.|Baseline to 5 Years|Participants who completed the BDI II questionnaire through month 60|||units on BDI scale||95% Confidence Interval|Mean
1257929|NCT00447590|Secondary|Change in Subjects' Comorbid Conditions|The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved.|Baseline to 5 Years|Subjects who had a specific comorbid condition at baseline (Diabetes n=9, Dyslipidemia n=39, Hypertension n=22)|||participants whose condition resolved|||Number
1257930|NCT00447590|Secondary|Subject Percent Excess BMI Loss|Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.|Baseline to 5 Years|Intent to treat (ITT) population with imputation at month 60|||kg/m2||95% Confidence Interval|Mean
1257931|NCT00447590|Secondary|Subject Excess Weight Loss Throughout the Study|Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.|Baseline to 5 Years|Intent to treat (ITT) population with imputation at month 60|||%EWL||Standard Deviation|Mean
1257932|NCT00447590|Primary|Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.|"Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.~Excess Weight = baseline weight – ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years."|1 year|Intent to treat (ITT) population with imputation at month 12 (ITT population consisted of participants treated with the LAP-BAND).|||percentage of participants|||Number
1257933|NCT00447499|Secondary|Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination|Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6.|24 weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26). Fifty-six of patients had data at Week 24.|||On a Scale from -6 to 6||Standard Deviation|Mean
1257934|NCT00447499|Secondary|Total Symptom Questionnaire Score at Week 24/Termination|Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10.|24 Weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).|||On a Scale from -10 to 10||Standard Deviation|Mean
1275935|NCT00307489|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48||48 Weeks|RAT Analysis Set|||U/mL||Standard Deviation|Mean
1257938|NCT00447499|Secondary|Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.|Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient.|24 weeks|Patients switched directly from octreotide.|||Percent of Participants|||Number
1257939|NCT00447499|Primary|The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.|The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').|24 weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).|||Percentage of Participants|||Number
1257940|NCT00447421|Secondary|Phase 2: Overall Survival|Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.|baseline to date of death from any cause|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||months||Standard Deviation|Mean
1257941|NCT00447421|Secondary|Phase 2: Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||months||Standard Deviation|Mean
1257942|NCT00447421|Secondary|Phase 2: Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|baseline to measured progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||months||Standard Deviation|Mean
1257943|NCT00447421|Secondary|Phase 2: Complete Response Rate|Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.|baseline to measured response time|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||participants|||Number
1257944|NCT00447421|Secondary|Phase 1: Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured response|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and was stopped too early to assess best overall response.|||participants|||Number
1257945|NCT00447421|Primary|Phase 2: Overall Response Rate|Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||participants|||Number
1257946|NCT00447421|Primary|Phase 1: Maximum Tolerated Dose||every cycle|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and it was too early to assess the recommended dose for Phase 2, or to estimate the maximum tolerated dose (MTD).|||milligrams per square meter||Standard Deviation|Mean
1257947|NCT00447382|Secondary|Adverse Events||Weeks 0-52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||events|||Number
1257948|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Total Protein)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||g/dL||Standard Deviation|Mean
1257949|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Sodium)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Deviation|Mean
1257950|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Potassium)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Deviation|Mean
1257951|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase)|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||U/L||Standard Deviation|Mean
1257952|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Creatinine)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a postbaseline observation.|||Umol/L||Standard Deviation|Mean
1257953|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALP = alkaline phosphatase)"|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||U/L||Standard Deviation|Mean
1257954|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALAT = alanine aminotransferase)"|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||U/L||Standard Deviation|Mean
1257955|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Albumin)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||g/dL||Standard Deviation|Mean
1257956|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Leucocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
1257957|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Thrombocytes)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||10^9/L||Standard Deviation|Mean
1257958|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Neutrophils)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
1257959|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Monocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
1257960|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Lymphocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
1257961|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Haemoglobin)|Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Deviation|Mean
1257962|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Eosinophils)|Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
1257963|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Basophilis)|"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
1257964|NCT00447382|Secondary|Change From Baseline in Total Antibodies|Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir – human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||ratio||Standard Error|Mean
1257965|NCT00447382|Secondary|Change From Baseline in Detemir Specific Antibodies|Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||ratio||Standard Error|Mean
1257966|NCT00447382|Secondary|Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])|"point is Before Breakfast~point is 120 minutes after Breakfast~point is Before Lunch~point is 120 minutes after Lunch~point is Before Dinner~point is 120 minutes after Dinner~point is at Bedtime~point is At 03:00 A.M.~point is Before Breakfast the Following Day"|week 0, 26 and 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Deviation|Mean
1257967|NCT00447382|Secondary|Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])||week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Error|Mean
1257968|NCT00447382|Secondary|Glycaemic Control Parameters (Change in HbA1c)|HbA1c (Glycosylated haemoglobin).|week 0, week 52|All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) glycosylated haemoglobin||Standard Error|Mean
1257969|NCT00447382|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal.|Weeks 0-52|All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||episodes|||Number
1257970|NCT00447382|Primary|Change From Baseline in Insulin Detemir – Human Insulin Cross-reacting Antibodies|Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||ratio||Standard Error|Mean
1257971|NCT00447330|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|5 years after study start date|All patients who received treatment are included in the analysis population. However, 2 patients who never started treatment before leaving the study were excluded from this analysis of survival time.|||survival time in months||90% Confidence Interval|Median
1257972|NCT00447330|Secondary|Response Rate|The proportion of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disese) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.|Every 9 weeks for up to 1 year|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1257973|NCT00447330|Secondary|To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma|Number of subjects who experienced an adverse event|Every 21 days||||participants|||Number
1257974|NCT00447330|Primary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. PER RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|5 years from study start date|All patients with at least one scheduled restaging who received treatment. However, an additional 3 patients who progressed before treatment are not included in this analysis.|||survival time in months||90% Confidence Interval|Median
1257975|NCT00447278|Secondary|Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores|Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP.|Baseline, 6 months|All randomized participants who received at least one dose of study drug and had non-missing values.|||correlation coefficient|||Number
1257976|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)|CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|"Number of adolescent participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n=27, OEST n=31). Their data at 6 months was taken as baseline for the 12 month change."|||T-Scores of units on a scale||Standard Deviation|Mean
1257977|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)|CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|"Number of child participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 112, OEST n=124). Their data at 6 months was taken as baseline for the 12 month change."|||T-Scores of units on a scale||Standard Deviation|Mean
1257978|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||units on a scale||Standard Deviation|Mean
1257979|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms.|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||units on a scale||Standard Deviation|Mean
1257980|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)|The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0=“never or not at all”, 1=”sometimes or somewhat”, 2=”often or much”, 3=“very often or very much”). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst).|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||units on a scale||Standard Deviation|Mean
1257981|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)|CHIP-CE PRF: parent rated assessment of a child’s health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||T-Scores of units on a scale||Standard Deviation|Mean
1257982|NCT00447278|Secondary|Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain|CHIP-CE PRF: parent rated assessment of a child’s health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||T-Scores of units on a scale||Standard Deviation|Mean
1257983|NCT00447278|Primary|Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain|CHIP-CE PRF: parent rated assessment of a child’s health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 6 months|Number of participants who received at least one dose of study drug and did not have a missing value. Results for Last Observation Carried Forward (LOCF) are included.|||T-Scores of units on a scale||Standard Deviation|Mean
1257984|NCT00447265|Secondary|Participant Medical Outcome Study Short Form 36 (SF-36) Mental Component Score at Baseline and Week 24|"Reported here are the participant SF-36 Mental Component scores at baseline and week 24. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, bodily pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions.[1] The Mental Component score of the SF-36 ranges from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.~[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey. Med Care. 1992; 30:473-483"|Baseline, Week 24||||Score on a scale|||Number
1257985|NCT00447265|Secondary|Participant Medical Outcome Study Short-Form 36 (SF-36) Physical Component Score at Baseline and Week 24|"Reported here is the participant baseline and week 24 SF-36 Physical Component scores. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, body pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions[1]. The Physical Component scores of the SF-36 range from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.~[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey Med Care. 1992; 30:473-483."|Baseline, Week 24||||Score on a scale|||Number
1257986|NCT00447265|Secondary|Number of Participants With an A to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Renal Score|Reported here is the number of participants with a change in their BILAG Renal Score from A (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum renal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system|Baseline, Week 24||||Participants|||Number
1257987|NCT00447265|Secondary|Number of Participants With a B to D Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Musculoskeletal Score|Reported here is the number of participants with a change in their BILAG Musculoskeletal Score from B (at baseline) to D (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum musculoskeletal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.|Baseline, Week 24||||Participants|||Number
1257988|NCT00447265|Secondary|Number of Participants With a C to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Mucocutaneous Score|Reported here is the number of participants with a change in their BILAG Mucocutaneous Score from C (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0). A maximum mucocutaneous score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.|Baseline, Week 24||||Participants|||Number
1257989|NCT00447265|Secondary|Participant Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Score at Baseline and at Early Study Withdrawal Visit|Reported here is the baseline and week 39 Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) scores. The SLEDAI is a concise measure of lupus disease activity with excellent test-retest reliability and high responsiveness to clinically important changes in the disease. The total score is derived from ratings on 24 conditions plus the Physician's Global Assessment; 0 indicates inactive disease and the maximum theoretical score is 105, with higher scores representing increased disease activity.|Baseline, Week 39 (Early Study Withdrawal Visit)||||Points on a scale|||Number
1257990|NCT00447265|Secondary|Time to Participant's Renal Response|"Time to when participant achieved a renal response[1]~[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the Modification of Diet in Renal Disease equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)"|First 24 Weeks of Study Period||||Weeks|||Number
1257991|NCT00447265|Secondary|Percent of Participants Who Achieved a Renal Response at Week 24|"Percent of study participants who achieved a renal response at 24 weeks.[1]~[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the Modification of Diet in Renal Disease equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)"|Week 24||||Percent of Participants|||Number
1257992|NCT00447265|Secondary|Number of Participant Adverse Events (AEs) From Baseline to Early Study Withdrawal Visit|Number of participant AEs during the trial. This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0.|39 Weeks||||Events|||Number
1257993|NCT00447265|Primary|Number of Adverse Events (AEs)Grade 3 or Higher Experienced by Participant During Treatment Phase of Study|"Number of adverse events (AEs) or serious adverse events (SAEs) Grade 3 or higher experienced by participant over the duration of the treatment period. [1]~[1] This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute’s Common Terminology Criteria for Adverse Events Version 3.0."|24 Weeks||||Events|||Number
1257994|NCT00447226|Secondary|Incidence of ErbB2-positive Participants|The number of ErbB2-positive participants (determined by FISH assay) compared to the total number of participants screened was to be recorded. Over-expression of ErbB2 has been correlated with an overall poor prognosis. Data were not analyzed, due to early study termination.|Screening|All participants who were screened to determine their eligibility to enter into the study|||participants per total screened|||Number
1257995|NCT00447226|Secondary|Incidence of MET Amplification in Gastric Cancer|The number of gastric cancer participants with MET amplification (determined by fluorescence in situ hybridization [FISH] assay) compared to the total number of gastric cancer participants screened was to be recorded. Amplification of the MET gene has been reported to be related to carcinogenesis, progression of gastric cancer, and poor prognosis. Data were not analyzed due to early study termination.|Performed on archived tissue collected at screening.|All participants with gastric cancer who were screened to determine their eligibility to enter into the study|||participants per total screened|||Number
1257996|NCT00447226|Secondary|Number of Participants With the Indicated Change in Cancer Antigen-125 (CA-125) Levels From Day 1|CA-125 is a “tumor marker”, found in greater concentration in tumor cells than other cells of the body. In particular, CA-125 is present in greater concentration in ovarian cancer cells than in other cells. A decreasing level generally indicates that therapy has been effective, whereas an increasing level indicates tumor recurrence.|Pre-dose and every 6 weeks until withdrawal (up to 84.1 weeks)|Participants with ovarian cancer. The number of participants for whom there are data varies at each time point, depending on how many participants had CA-125 samples.|||participants|||Number
1258022|NCT00447005|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose||Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.|||hours||Full Range|Median
1275936|NCT00307489|Secondary|Change From Baseline in log10 Plasma HBV DNA Levels at Week 48||48 Weeks|RAT Analysis Set|||log10 copies/mL||Standard Deviation|Mean
1257997|NCT00447226|Secondary|Time to Disease Progression (TTP)|"Time to disease progression was calculated as the time from the start of treatment to disease progression or death due to disease progression. For participants who did not progress, the date of last contact was used and for those who died due to other causes, the date of death was used. The word used for such participants was censored. As the median value in the placebo arm was not reached (2 participants were censored and 2 were ongoing), results for the placebo arm are not displayed in the table below."|From start of treatment to disease progression/death (up to 83.3 weeks)|All Treated: all participants who received at least one dose of open-label lapatinib.|||weeks||95% Confidence Interval|Median
1257998|NCT00447226|Secondary|Progression-free Survival (PFS)|"Progression-free survival was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored. Data were not analyzed due to early study termination."|From start of treatment to disease progression/death (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)|All treated: all participants who received at least one dose of open-label lapatinib.|||weeks||95% Confidence Interval|Median
1257999|NCT00447226|Secondary|Duration of Response|Duration of response was calculated as the time from first documented partial response (PR; >=30% decrease in the measurements of the largest lesions) or complete response (CR; disappearance of all lesions) until disease progression, the time when the participant began a new anti-cancer therapy, or death. Data were not analyzed due to early study termination.|(assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)|All treated: all participants who received at least one dose of open-label lapatinib.|||weeks||95% Confidence Interval|Median
1258000|NCT00447226|Primary|Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization|The percentage of participants who did not show signs of progressive disease 12 weeks after receiving lapatinib or placebo in Stage 2 of the study (participants who maintained SD in Stage 1 were randomized to either lapatinib or placebo) was measured. Formal statistics for treatment comparison were not performed, due to early study termination. The percentage of participants displayed below includes those with CR + PR + SD.|Week 12 after randomization.|Intent-to-Treat Population: all participants randomized to study treatment in Stage 2|||percentage of participants|||Number
1258001|NCT00447226|Primary|Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose|Per Response Evaluation Criteria In Solid Tumors (RECIST): Complete response (CR), disappearance of all lesions; partial response (PR), >=30% decrease in the measurements of the largest lesions; stable disease (SD), insufficient shrinkage to qualify for PR or insufficient increase to qualify for progressive disease (PD); PD, >=20% increase in measurements of lesions or appearance of new lesions. Data were not fully analyzed due to early study termination.|Week 12|All treated: all participants who received at least one dose of open-label lapatinib.|||participants|||Number
1258002|NCT00447122|Primary|Number of Patients Who Survived at 4 Months: Overall Survival||4 months||||participants|||Number
1258003|NCT00447083|Secondary|Pain Scores of the UV and Non-UV Exposure (Phase II)|The pain scores were assessed using a Likert Scale. Pain will be assessed on an 11-point pain Likert scale where 0=no pain and 10=worst possible pain.|4 weeks post-treatment||||score on a scale||Standard Error|Mean
1258004|NCT00447083|Secondary|Post-treatment Pain Scores- Likert Scale (Phase I)|As a secondary outcome, the post-treatment pain scores between the UV and non-UV exposures given on the first day the dose is given will be compared. Pain will be assessed on an 11-point pain Likert scale where 0=no pain and 10=worst possible pain|2 weeks||||score on a scale||Standard Deviation|Mean
1258005|NCT00447083|Primary|Pain Score- Likert Scale(Phase II)|Pain will be assessed on an 11-point pain scale where 0=no pain and 10=worst possible pain. A 30% improvement in reported pain will be considered a treatment “success.|6 weeks||||score on a scale||Standard Error|Mean
1258006|NCT00447083|Primary|Pain Relief Success Rates (Phase I)|Percentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale.|2 weeks||||percentage of exposures with relief|||Number
1258007|NCT00447057|Secondary|Number of Participants With Adverse Events (AEs)|Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.|Baseline up to 42.2 months|All participants who received at least 1 dose of study drug were analyzed for safety. Nonsquamous and squamous populations are combined.|||participants|||Number
1258008|NCT00447057|Secondary|Percentage of Participants Surviving at 1 Year|Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.|Baseline to date of death from any cause up to 1 year|"Includes nonsquamous population only.~On the Pemetrexed arm, 17 participants were censored overall and on the Pemetrexed + Erlotinib arm, 28 participants were censored overall."|||Percentage participants with OS ≥1 year||95% Confidence Interval|Median
1258009|NCT00447057|Secondary|Overall Survival (OS)|OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.|Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.|Pemetrexed arm: 17 (20.5%) participants censored Pemetrexed + Erlotinib arm: 28 (36.8%) participants censored|||months||95% Confidence Interval|Median
1258010|NCT00447057|Secondary|Time to Treatment Failure (TTTF)|"Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than “protocol complete” or “satisfactory response”. For participants who discontinued due to protocol complete or satisfactory response, or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date."|"Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than protocol complete or satisfactory response. Maximum follow-up was from Baseline to 32.2 months"|Includes nonsquamous population only.|||months||95% Confidence Interval|Median
1258023|NCT00447005|Secondary|Maximum Observed Plasma Concentration (Cmax): Single Dose||Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.|||ng/mL||Standard Deviation|Mean
1258011|NCT00447057|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)|"CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.~PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100."|Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months|Includes nonsquamous population only.|||percentage of participants||95% Confidence Interval|Number
1258012|NCT00447057|Secondary|Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)|"Per RECIST:~CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.~PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100."|Baseline to measured PD. Maximum follow-up was from Baseline to 34 months|Includes nonsquamous population only.|||percentage of participants||95% Confidence Interval|Number
1258013|NCT00447057|Primary|Progression Free Survival (PFS)|PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.|Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months|"Includes Nonsquamous population only.~In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy.~In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy."|||months||95% Confidence Interval|Median
1258014|NCT00447005|Secondary|The Numbers of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 795 days|Participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug (Anti-tumor Response Analysis Set).|||participants|||Number
1258015|NCT00447005|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.|Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation|Participants who received at least one study drug and completed pharmacodynamic blood sampling for at least one day (Pharmacodynamic Analysis Set); n= number of participants assessed.|||percent change||Full Range|Median
1258016|NCT00447005|Secondary|Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.|||ratio||Standard Deviation|Mean
1258017|NCT00447005|Secondary|Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose|Dosing Interval was 12 hours in this study.|Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.|||ng*h/mL||Standard Deviation|Mean
1258018|NCT00447005|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose||Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.|||hours||Full Range|Median
1258019|NCT00447005|Secondary|Maximum Observed Plasma Concentration (Cmax): Multiple Dose||Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.|||ng/mL||Standard Deviation|Mean
1258020|NCT00447005|Secondary|Terminal Phase Plasma Half-Life (t1/2): Single Dose|t1/2 is the time measured for the plasma concentration to decrease by one half.|Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.|||hours||Standard Deviation|Mean
1258021|NCT00447005|Secondary|Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.|||ng*hr/mL||Standard Deviation|Mean
1258110|NCT00446264|Secondary|Plasma C-peptide|Level of plasma C-peptide at 1 year after the first transplant|1 year||||ng/ml||Standard Deviation|Mean
1258024|NCT00447005|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.|Up to 795 days of treatment plus 28-days follow-up|All subjects who received at least 1 dose of the study drug.|||participants|||Number
1258025|NCT00446992|Primary|LDL||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
1258026|NCT00446992|Primary|HDL||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
1258027|NCT00446992|Primary|Cholesterol Total||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
1258028|NCT00446992|Primary|Triglycerides||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
1258029|NCT00446992|Primary|IL-6||Baseline and 4 week intervals||||pg/mL||Standard Deviation|Mean
1258030|NCT00446992|Primary|Hemoglobin A1c||Baseline and 4 week intervals||||percentage||Standard Deviation|Mean
1258031|NCT00446992|Primary|Fasting Insulin||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
1258032|NCT00446992|Primary|Fasting Glucose||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
1258033|NCT00446992|Primary|Body Mass Index||Baseline and 4 week intervals||||kg/m^2||Standard Deviation|Mean
1258034|NCT00446966|Primary|Number of Participants Who Developed Postoperative Atrial Fibrillation|The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.|14 days|Intention to treat|||participants|||Number
1258035|NCT00446849|Secondary|Endoscopic Remission of UC During the Maintenance Phase at 12 Months|Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].|12 Months|MPEP with non-missing data at 12 months.|||Participants|||Number
1258036|NCT00446849|Secondary|Quiescent UC During the Maintenance Phase at 12 Months|Quiescent UC is defined as scores of 0 for both rectal bleeding and bowel movements. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Bowel movements are assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).|12 Months|MPEP with non-missing data at 12 months.|||Participants|||Number
1258037|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 12 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: (Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals) x 100.|12 months|MPEP with non-missing data for clinical recurrence at 12 months.|||Percent of participants|||Number
1258038|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 6 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: [(Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals)] x 100.|6 Months|MPEP with non-missing data for clinical recurrence at 6 months.|||Percent of participants|||Number
1258039|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase at 12 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.|12 Months|MPEP|||participants|||Number
1258040|NCT00446849|Primary|Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.|6 months|Maintenance phase efficacy population (MPEP) includes all subjects who, during the maintenance phase, took at least 1 dose of study medication and had at least 1 post-dose efficacy assessment.|||participants|||Number
1258041|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Index|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~The pain interference index is the average of pain interference questions 5A to 5G. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258042|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5G|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5G: Subject response to ‘how, during the past 24 hours, pain has interfered with your enjoyment of life’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258043|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5F|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5F: Subject response to ‘how, during the past 24 hours, pain has interfered with your sleep’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258111|NCT00446264|Secondary|Hypoglycemic Events|Percentage of subjects free of severe hypoglycemic events from day 0 to day 365 with the day of transplant designated day 0|day 0 to day 365||||Percentage of patients||Standard Deviation|Mean
1289131|NCT00135707|Secondary|Maternal Death||Delivery through hospital discharge|One maternal death in each group due to peripartum cardiomyopathy.|||Participants|||Count of Participants
1258044|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5E|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5E: Subject response to ‘how, during the past 24 hours, pain has interfered with your relations with other people’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258045|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5D|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5D: Subject response to ‘how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258046|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5C|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5C: Subject response to ‘how, during the past 24 hours, pain has interfered with your walking ability’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258047|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5B|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5B: Subject response to ‘how, during the past 24 hours, pain has interfered with your mood’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258048|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5A|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5A: Subject response to ‘how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258049|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Pain severity index is the average of the pain severity questions 1 to 4. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258050|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q4: Subject response to 'how much pain you have right now'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258051|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q3: Subject response to 'describe your pain on the average'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258052|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q2: Subject response to 'describe your pain at its least in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258053|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q1: Subject response to 'describe your pain at its worst in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 1, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
1258054|NCT00446797|Secondary|Subject Assessment of Normal Function / Activity|Subject response to question: “How does your ankle injury affect your walking and normal activity?” Scale from 1 = Normal walking/activity and no pain to 5 = Severely restricted walking due to pain and can’t resume normal activities (normal activities defined as all activity that a subject did on a routine basis, including work and recreation)|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||participants|||Number
1258055|NCT00446797|Secondary|Pain Relief - MITT Population|"Subject's response to the statement My relief from starting pain is. Scale from 0 = None to 4 = Complete."|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||participants|||Number
1289132|NCT00135707|Secondary|Cesarean Delivery||Delivery||||Participants|||Count of Participants
1258056|NCT00446797|Secondary|Physician Global Assessment of Ankle Injury|Investigator evaluation of overall severity of ankle injury. Scale: 5 point from 1 = Very mild (very mild signs and symptoms of ankle sprain) to 5 =Very severe (very severe signs and symptoms of ankle sprain)|Days 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||participants|||Number
1258057|NCT00446797|Secondary|Subject's Global Assessment of Ankle Injury|Subject response to question: “Considering all the ways your ankle injury affects you, how are you doing today?” Scale: 5 point from 1 = very good (no symptoms and no limitation of normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||participants|||Number
1258058|NCT00446797|Secondary|Number of Subjects Responding (Improving) - MITT Population|The number of subjects showing a response: a decrease of at least 20 mm (that is improvement) on the pain visual analog scale (VAS) scale|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).|||participants|||Number
1258059|NCT00446797|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population|Assessment of ankle pain by VAS: 100 mm horizontal line, left end being “No Pain” & right end being “Worst Possible Pain”. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at observation minus mean score at baseline|Baseline and days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).|||scores on a scale||Standard Deviation|Mean
1258060|NCT00446797|Primary|Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population|Assessment of ankle pain by VAS: 100 mm horizontal line with left end being “No Pain” & right end being “Worst Possible Pain”. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline|Baseline and day 3|Per protocol (PP) population included subjects who were randomized, received full loading dose of study medication on day 1 and took no prohibited medications up to and including day 3, had valid baseline and day 3 VAS scores and had no major protocol violations before or during the study (i.e. a subset of treated subjects).|||scores on a scale||Standard Deviation|Mean
1258061|NCT00446654|Primary|Change in Baseline to 3 Months in Best Corrected Visual Acuity|"Visual acuity was measured with a standard eye exam using the preferred research based eye chart (LogMar chart). On the LogMar chart each letter has a score value of 0.02 log units. LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of letters read).~The outcome measure presented is the difference in LogMAR between baseline and at three months."|Baseline and 3 months|Analysis was performed on all patients who received at least one treatment.|||logMAR||Standard Deviation|Mean
1258062|NCT00446654|Secondary|To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization||3 months|||||||
1258063|NCT00446654|Secondary|Safety of 2-weekly or 4-weekly Administration of CGC-11047||3 months|||||||
1258064|NCT00446641|Secondary|Post-treatment ARU|mean of ARU value of individual participants after 4 weeks treatment|after 4 weeks treatment||||ARU||Standard Deviation|Mean
1258065|NCT00446641|Secondary|Difference of Post-treatment ARU and Baseline ARU|summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients|baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication||||change of ARU measured||Standard Deviation|Mean
1258066|NCT00446641|Secondary|Any Bleeding Complications|any bleeding events causing medical attention|events ocurred during study medication after randomization||||participants|||Number
1258067|NCT00446641|Secondary|Fatal or Major Bleeding Complications;|Fatal or life-threatening bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood|events ocurred during study medication after randomization||||participants|||Number
1258068|NCT00446641|Secondary|Bleeding Time (BT)|for evaluation of the extent of the bleeding time prolongation by additional cilostazol|4 weeks after reatment||||seconds||Standard Deviation|Mean
1258069|NCT00446641|Secondary|Aspirin Resistance (ARU ≥ 500)|The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values|4 weeks after reatment||||participants|||Number
1258070|NCT00446641|Primary|Aspirin Resistance (ARU ≥ 550)|The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients|4 weeks after treatment||||participants|||Number
1258071|NCT00446563|Secondary|Percentage of Participants Who Experienced Adverse Events (AEs)|An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.|Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.|||Percentage of participants|||Number
1258112|NCT00446264|Primary|Composite Criteria: Insulin Independence and Glycosylated Hemoglobin (HbA1c) Under 6.5% at One Year|The percentage of insulin independents subjects with an HbA1c less than 6.5% at one year after last transplant|1 year||||Percentage of patients||Standard Deviation|Mean
1258113|NCT00446251|Secondary|The Number of Subjects With a Negative Crossmatch at the Time of Transplant.||Month 12 from start of study|As per protocol each subject was entered with intention to treat.|||Participants|||Number
1258072|NCT00446563|Secondary|Percentage of Participants Achieving Target Blood Pressure at Week 52|Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg.|Week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||Percentage of participants|||Number
1258073|NCT00446563|Secondary|Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)||Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.|||mg/l||Standard Deviation|Mean
1258074|NCT00446563|Secondary|Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)||Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.|||pg/ml||Standard Deviation|Mean
1258075|NCT00446563|Secondary|Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||mm||Standard Deviation|Mean
1258076|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||cm˄2||Standard Deviation|Mean
1258077|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||ml||Standard Deviation|Mean
1258078|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||ml||Standard Deviation|Mean
1258079|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||ml||Standard Deviation|Mean
1258080|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||ml||Standard Deviation|Mean
1258081|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI|Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.|Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||Percentage||Standard Deviation|Mean
1258082|NCT00446563|Secondary|Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||mm||Standard Deviation|Mean
1258083|NCT00446563|Secondary|Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||mm||Standard Deviation|Mean
1258084|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||g/m˄2||Standard Deviation|Mean
1258085|NCT00446563|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||g/m˄2||Standard Deviation|Mean
1258086|NCT00446550|Secondary|Change From Baseline To End Of Treatment In β-glucocerebrosidase (GCase) Levels In White Blood Cells (WBC)|GCase is a biomarker used to assess the PD effects of afegostat tartrate. Blood samples were collected to assess GCase levels in WBC. The baseline value was defined as the last non-missing value before the start of study drug.|Baseline, Day 169|PD Population: all participants who were included in the Safety Population and had a baseline and at least 1 post-baseline PD measurement.|||picomole/minute/mg||Standard Deviation|Mean
1283002|NCT00234286|Secondary|Individuals Who Received Benzodiazepine Medication|Administration of benzodiazepine medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1258087|NCT00446550|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe AE defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 through the end of follow-up (Day 183) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Day 183|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1258088|NCT00446511|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.|Core Baseline (Week 0) to Week 26|Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.|||mmHg||Standard Deviation|Mean
1258089|NCT00446511|Secondary|Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20|24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm.|Core Baseline (Week 0) to Week 20|ABPM population: All ITT patients who received the 24-hour ambulatory blood pressure monitoring (ABPM) measurements at both baseline and Week 20. Patients were excluded if their baseline ABPM was measured after active treatment dose (considered invalid baseline).|||mmHg||Standard Deviation|Mean
1258090|NCT00446511|Secondary|Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26|Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP < 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.|Week 26|The extension ITT population consisted of all extension patients that had both baseline and at least one post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic blood pressure) during the extension. Patients were analyzed according to the treatment they were assigned to at the beginning of their extension.|||Percentage of patients|||Number
1258091|NCT00446511|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.|Core Baseline (Week 0) to Week 26|Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.|||mmHg||Standard Deviation|Mean
1258092|NCT00446511|Primary|Number of Patients With Adverse Events||Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)|Extension safety population|||Participants|||Number
1258093|NCT00446459|Secondary|The Number of Transplants With a Negative Crossmatch at Transplant.|The number negative crossmatch transplants up to month 12. Positivie crossmatch transplant carries a higher risk for rejection. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for negative crossmatch transplants to 12 months.|Number of Transplants with a Negative Crossmatch.||||Participant|||Number
1258094|NCT00446459|Secondary|The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL).|The number of subjects with adverse hematologic effects with MMF while on-study. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for hematologic effects up to 12 months.|Enrollment to month 12.||||Participant|||Number
1258095|NCT00446459|Secondary|The Number of Kidney Transplant up to 12 Months.|The number of kidney transplants up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.|Enrollment to month 8 or month 12 post enrollment.||||Participants|||Number
1258096|NCT00446459|Primary|The Number of Subjects With a 10% Decrease in PRA Level at Month 8.||Enrollment to month 8||||Participant|||Number
1258097|NCT00446459|Secondary|The Number of Subjects With Significant Infections up to Month 12.|The number of infections while on-study up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.|From enrollment to month 12.|Forty five subjects were screened, of these 37 received MMF.|||Participants|||Number
1258114|NCT00446251|Secondary|The Number of Subjects Who Experience a Change From Baseline in Their Panel of Reactive Antibody (PRA) Titers at 12 Months Post Rituximab Infusion.||Month 12 from start of study||||Participants|||Number
1267502|NCT00380250|Secondary|Month 2 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
1258098|NCT00446446|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal) with the exception of some dermatology/skin AEs that were graded using the CTCAE v3.0 with modifications. Serious AEs include any event that was fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related adverse events (TRAEs) are those for which the investigator considered there to be a reasonable possibility that the event may have been caused by study drug.|The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months.|Safety analysis set (all enrolled participants who received at least 1 dose of panitumumab)|||participants|||Number
1258099|NCT00446446|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from Day 1 to the date of death. For participants who did not die while on study, or were lost to follow-up, survival was censored at the end of study, or the date of last contact (whichever was first).|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set|||months||95% Confidence Interval|Median
1258100|NCT00446446|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from Day 1 to the first date of disease progression, as defined by a modified version of the RECIST criteria (version 1.0), or death due to any cause (whichever comes first). Participants who were alive who did not meet the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment.~PFS was analyzed using the Kaplan-Meier method."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set|||months||95% Confidence Interval|Median
1258101|NCT00446446|Secondary|Time to Progression|Time to progression was defined as the time from Day 1 to the date of disease progression using a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Time to progression was analyzed using the Kaplan-Meier method.|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set|||months||95% Confidence Interval|Median
1258102|NCT00446446|Secondary|Rate of Disease Control|"Rate of disease control was defined as the percentage of participants with CR, PR, or stable disease (SD), as defined by a modified version of the RECIST criteria (version 1.0), prior to initiation of subsequent anti-cancer therapy.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of non-target lesions and no new lesions, or, if no target lesions were identified at screening, the persistence of one or more non-target lesion(s) not qualifying for either CR or PD."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set with measurable disease at Baseline|||percentage of participants||95% Confidence Interval|Number
1258103|NCT00446446|Secondary|Duration of Response|"Duration of response was defined as the time from first confirmed CR or PR to the earliest date of disease progression per a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Duration of response was analyzed using the Kaplan-Meier method.~PD: At least a 20% increase in the size of target lesions, or an increase of 20% or greater of non-target lesions and the lesion(s) measure ≥ 10 mm in one dimension at the time of progression, or any new lesions."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)|Full analysis set participants with an objective response|||months||95% Confidence Interval|Median
1258104|NCT00446446|Secondary|Time to Response|Time to response was defined as the time from Study Day 1 to the first CR or PR that was subsequently confirmed.|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)|Full analysis set participants with objective responses|||weeks||Inter-Quartile Range|Median
1258105|NCT00446446|Primary|Objective Response Rate|Assessments are based on investigator’s review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.|From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set (all enrolled participants who received at least 1 dose of panitumumab) with measurable disease at Baseline|||percentage of participants||95% Confidence Interval|Number
1258106|NCT00446290|Primary|Number of Participants With DLTs|Dose limiting toxicity (DLTs) was determined during the Wrst two cycles of treat- ment. The definitions of DLTs were as follows: (1) grade 4 neutropenia lasting for more than 5 days, or grade 3/4 neu- tropenia with fever; (2) grade 4 thrombocytopenia; (3) any other grade 3 non-hematological toxicity (excluding alope- cia); or (4) treatment delay of more than 2 weeks following the time of planned treatment. Maximal tolerated dose was defined as that the DLTs were observed in two or more patients from a cohort of two to six patients|2 years|All patients who were initially enrolled in dose escalation scheme.|||participants|||Number
1258107|NCT00446264|Secondary|Number of Adverse Events|The number of adverse events related to the procedure and to the immunosuppression|1 year||||number events|||Number
1258108|NCT00446264|Secondary|Percentage of Time Spent in Hypoglycemia (<0.70 mg/L)|percentage of time spent in hypoglycemia derived from CGMS (Continuous Glucose Monitoring System)|1 year||||percentage of time||Standard Deviation|Mean
1258109|NCT00446264|Secondary|HbA1c < 6.5%|The percentage of subjects with HbA1c < 6.5% at 1 year after the first transplant|1 year||||Percentage of participants||Standard Deviation|Mean
1258115|NCT00446251|Primary|The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion.|the number of subjects who experience a decrease in their Panel of Reactive Antibodies (PRA) at 6 months and 12 months post Rituximab infusion|Month 6 from start of study|12 subjects received the full dose of Rituximab AND continued to month 6 post infusion.|||Participants|||Number
1258116|NCT00446199|Other Pre-specified|Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity moderate to severe hot flushes minus baseline severity.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||scores on a scale||Standard Deviation|Mean
1258117|NCT00446199|Other Pre-specified|Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity moderate to severe hot flushes minus baseline severity.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Scores on a scale||Standard Deviation|Mean
1258118|NCT00446199|Other Pre-specified|Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Hot Flushes per week||Standard Deviation|Mean
1258119|NCT00446199|Other Pre-specified|Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Hot Flushes per week||Standard Deviation|Mean
1258120|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'|Subjects self-assessed presence or absence of symptom; and if present recorded average number of times per night: 1; 2 to 4; more than 4.|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
1258121|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'|Subjects self-assessed presence or absence of symptom|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
1258122|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'|Subjects self-assessed presence or absence of symptom|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
1258123|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
1258124|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
1258125|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
1258126|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
1258127|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
1258128|NCT00446199|Secondary|Change From Baseline to Week 12 in Vaginal Maturation Value|Calculated as (percentage of superficial cells) + 0.5 * (percentage of intermediate cells). Absolute change calculated as week 12 value minus baseline value.|Baseline until 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||Percentages of cells||Standard Deviation|Mean
1258129|NCT00446199|Secondary|Change From Baseline to Week 12 in Vaginal pH|Vaginal pH determined following speculum examination using vaginal pH paper and recorded on case report form (CRF). Absolute change calculated as week 12 pH minus baseline pH.|Baseline until 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||(pH)||Standard Deviation|Mean
1258142|NCT00446095|Primary|Clinical Benefit Rate as Assessed According to the “Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).|Proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD)|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.|||Participants|||Number
1258130|NCT00446199|Primary|Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Scorese on a scale||Full Range|Median
1258131|NCT00446199|Primary|Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Scores on a scale||Full Range|Median
1258132|NCT00446199|Primary|Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Hot Flushes per week||Full Range|Median
1258133|NCT00446199|Primary|Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.|Baseline until 12 weeks of treatment|Full analysis set (Intention to Treat (ITT)) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Hot Flushes per week||Full Range|Median
1258134|NCT00446147|Secondary|Number of Patients With Hand-foot Syndrome|Number of patients with any grade of hand-foot syndrome|Up to 2 years||||participants|||Number
1258135|NCT00446147|Primary|Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome|A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.|Up to 2 years||||miligram per square meter||95% Confidence Interval|Median
1258136|NCT00446134|Secondary|Relapsers at Follow-Up Visit 24|Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug.|Follow-Up Week 24|The analysis was performed using patients who had undetectable HVC RNA at their last visit on drug.|||Participants|||Number
1258137|NCT00446134|Secondary|Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24||Treatment Week Follow-Up 24|This analysis was performed using the Intent-to-Treat Population (ITT); undetectable HCV RNA defined as <100 copies/mL;Patients with a missing value at TW 12, TW 24 were considered Non-responders (detectable); a responder is defined as a patient with undetectable HCV RNA at FW 24 after achieving EVR at TW 12 and undetectable status at TW 24|||Participants|||Number
1258138|NCT00446134|Secondary|Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24|The primary safety endpoint will be the numbers of patients with hemoglobin <10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed.|Treatment Week Follow-Up 24|The secondary analysis was performed using the Safety Population and 275 patients who received at least one dose of study drug were analyzed for safety.|||Participants|||Number
1258139|NCT00446134|Primary|Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.|The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as <100 copies/mL serum HCV RNA. A PR is defined as < 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.|Treatment Week 12|The primary efficacy analysis was performed using the Intent-to-Treat (ITT) population and 275 patients who received at least one dose of study drug were analyzed for efficacy.|||Participants|||Number
1258140|NCT00446095|Secondary|Overall Survival (OS)|OS: Time from date of first study drug administration to the date of death.|Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days)|Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.|||Days||95% Confidence Interval|Median
1258141|NCT00446095|Secondary|Progression Free Survival (PFS)|PFS: Time from date of first study drug administration to the date of progressive disease as assessed according to the “Revised Response Criteria for Malignant Lymphoma”(Cheson 2007) or the date of death due to any cause, whichever occurred first.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.|||Days||95% Confidence Interval|Median
1258205|NCT00445484|Primary|23F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.|||fold change||Standard Error|Mean
1289133|NCT00135707|Secondary|Placental Abruption||During pregnancy||||Participants|||Count of Participants
1258143|NCT00446095|Primary|Overall Response Rate as Assessed According to the“Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).|Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.|||Participants|||Number
1258144|NCT00446030|Secondary|Disease-free Survival (DFS) & Overall Survival (OS) of Participants|"DFS is the time from study registration until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. For participants who are removed from the study follow-up prior to documentation of the tumor recurrence, DFS will be censored at the last date the participant was known to be disease-free.~OS is the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive."|up to 10 years|"Based on a protocol amendment~this study was shortened from 10 years to 2 years~the efficacy endpoints of disease free survival, and overall survival were deleted from the protocol.~Therefore, no analysis was performed for DFS or OS."|||Months||95% Confidence Interval|Median
1258145|NCT00446030|Primary|Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)|The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.|up to 2 years|Safety population - all participants who received at least 1 dose of any study treatment.|||Percentage of Participants||95% Confidence Interval|Mean
1258146|NCT00445939|Secondary|Clinical Remission (CDAI <150) at Week 6 and Week 8|The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8|Week 6 and Week 8|Subjects who were rated as non-responders (CDAI reduction < 70) in the evaluation of clinical remission (CDAI<150) at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + adalimumab 160/80 mg.|||Participants|||Number
1258147|NCT00445939|Secondary|Clinical Response (CR-70 and CR-100) in Period B|The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8.|Week 6 and Week 8|Full analysis set - subjects rated as non-responders (did not attain CDAI reduction >= 70) in the evaluation of CR-70 and CR-100 at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + 160/80 mg.|||Participants|||Number
1258148|NCT00445939|Secondary|Clinical Response (CR-70 and CR-100) in Period A|The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4.|Weeks 2 and Week 4|The secondary efficacy analysis was performed using descriptive statistics in randomized subjects who received at least one dose of study drug (full analysis set) in the three treatment groups: Adalimumab 160 mg/80 mg, adalimumab 80mg/40 mg, and placebo.|||participants|||Number
1258149|NCT00445939|Secondary|Clinical Remission (CDAI < 150) at Week 2|Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2.|Week 2|Subjects with a clinical remission (CDAI <= 150) in the adalimumab 160 mg (Week 0/80 mg (Week 2) and adalimumab 80 mg (Week 0)/40 mg (Week 2) in full analysis set using Non-responder Imputation.|||Participants|||Number
1258150|NCT00445939|Primary|The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4|CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.|4 Weeks|The primary analysis will be performed on the full analysis set (randomized subjects who received at least one dose of study drug) using the non-responder imputation for missing remission observations.|||Particpants|||Number
1258151|NCT00445887|Other Pre-specified|Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue|The median proportion of cells that are considered to be apoptotic are counted in the fallopian tube tissue sample, among the total number of cells available in the sample slide|Surgical specimen (4-6 weeks after entry)|Patients with evaluable slides|||proportion of total cells||Inter-Quartile Range|Median
1258152|NCT00445887|Secondary|Patients With High Expression of Transforming Growth Factor-beta 1||Baseline to time of surgery (4 to 6 weeks)|All eligible, treated and evaluable for Transforming Growth factor-beta|||Participants|||Count of Participants
1258153|NCT00445887|Secondary|Proportion of Proliferation as Measured by Ki-67||Time of surgery (4 to 6 weeks after entry)|All eligible, treated patients with an evaluable sample.|||Proportion of cells exhibiting Ki-67||Inter-Quartile Range|Median
1258154|NCT00445887|Primary|Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0|Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death.|Up to 20 weeks|All eligible and treated patients who had toxicity on study.|||Participants|||Count of Participants
1267503|NCT00380250|Secondary|Month 3 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3||||Scale score||Standard Deviation|Mean
1258155|NCT00445887|Primary|Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue|The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide.|Surgical specimen (4 - 6 weeks after entry)|Patients with evaluable slides. 14 of the cases did not have ovarian tissue available for evaluation. 50 cases were available for the primary analysis.|||proportion of total cells||Inter-Quartile Range|Median
1258156|NCT00445848|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.|Eligible patients who had received the protocol treatments were included in the adverse event summaries.|||Participants|||Number
1258157|NCT00445848|Secondary|Response Rate (Complete and Partial)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~All target measurable lesions must be assessed using the same techniques as baseline."|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.|Only patients with measurable disease at baseline were included in the analysis. 66 of 85 patients (78%) had measurable disease at baseline.|||participants|||Number
1258158|NCT00445848|Secondary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0), as a 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, or unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided) or appearance of any new lesion/site, or death due to disease without prior documentation of progression and without symptomatic deterioration.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.||||months||95% Confidence Interval|Median
1258159|NCT00445848|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.||||months||95% Confidence Interval|Median
1258160|NCT00445770|Other Pre-specified|Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses||Weeks 12, 24, 52|mITT; n = evaluable participants at the specified time point.|||nanograms per milliliter (ng/mL)||Standard Error|Mean
1258161|NCT00445770|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||mm/hr||Standard Deviation|Mean
1258162|NCT00445770|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|CRP: marker of inflammation. Higher level consistent with inflammation. Normal CRP range: 0 to 1.0 milligrams per deciliter (mg/dL).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||mg/dL||Standard Deviation|Mean
1258163|NCT00445770|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|DAS based on 28 painful joint counts, 28 swollen joint counts, ESR, and GH. DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH. Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
1258164|NCT00445770|Secondary|Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|DAS: weighted calculation of joint tenderness score (Ritchie Articular Index[RAI]), swollen joint count of 44 joints, natural logarithm (ln) of erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using VAS. RAI defined as sum of 26 possible 0 to 3 tender scores. DAS = 0.53938 square root (√) (RAI) + 0.06465 (swollen joint count) + 0.330 (ln ESR) + 0.00722 (GH). Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
1258165|NCT00445770|Secondary|Percentage of Participants With an ACR70 Response|ACR70 response: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Percentage of participants|||Number
1258166|NCT00445770|Secondary|Percentage of Participants With an ACR50 Response|ACR50 response: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Percentage of participants|||Number
1258206|NCT00445484|Primary|19F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.|||fold change||Standard Error|Mean
1258167|NCT00445770|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Percentage of participants|||Number
1258168|NCT00445770|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Change = scores at observation minus score at Baseline and total possible scores ranged from -3 to 3. An increase in score from baseline represented disease progression and/or joint worsening and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
1258169|NCT00445770|Secondary|Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|"100mm line (VAS) marked by participant. Participants asked, In general how would you rate your health over the last 2-3 weeks? 0mm=very well to 100mm=extremely bad. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||mm||Standard Deviation|Mean
1258170|NCT00445770|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|100 millimeter (mm) line (VAS) marked by participant. Intensity of pain range (over past week): 0mm = no pain to 100mm = worst possible pain. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||mm||Standard Deviation|Mean
1258171|NCT00445770|Secondary|Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Morning stiffness in and around the joints lasting at least 1 hour before maximal improvement. Change = scores at observation minus score at Baseline. An increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Minutes||Standard Deviation|Mean
1258172|NCT00445770|Secondary|Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Patient's Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
1258173|NCT00445770|Secondary|Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Physician Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
1258174|NCT00445770|Secondary|Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|71 joints assessed by the investigator using criteria based on pressure and joint manipulation. Change = scores at observation minus score at Baseline, and total possible scores ranged from -71 to 71. An increase in tender joint count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Tender Joints||Standard Deviation|Mean
1258175|NCT00445770|Secondary|Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|American College of Rheumatology (ACR) swollen joint count was an assessment of 68 joints. Joints classified as either swollen or not swollen. Change = scores at observation minus score at Baseline, and total possible scores ranged from -68 to 68. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Modified ITT (mITT) population: participants who received at least 1 dose of the assigned test article; Last Observation Carried Forward (LOCF)|||Swollen Joints||Standard Deviation|Mean
1258176|NCT00445770|Secondary|Percentage of Participants With no Progression of Joint Destruction at Week 52|Absence of joint destruction defined by 3 categories (mTSS change <=0.5, <=3.0, and <smallest detectable difference [SDD] where SDDs were scores >3.0). mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score).|Baseline and Week 52|rITT|||Percentage of participants|||Number
1258177|NCT00445770|Secondary|Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52|JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, and Week 52|rITT|||Scores on a scale||Standard Error|Mean
1258207|NCT00445484|Primary|14F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.|||fold change||Standard Error|Mean
1258178|NCT00445770|Secondary|Change From Baseline in Erosion Score at Weeks 24 and 52|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, and Week 52|rITT|||Scores on a scale||Standard Error|Mean
1258179|NCT00445770|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Week 24|rITT|||Scores on a scale||Standard Error|Mean
1258180|NCT00445770|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Week 52|Radiographic intent-to-treat (rITT) population: all participants who received at least 1 dose of the assigned test article and provided radiographic data for baseline and at least 1 post-baseline visit|||Scores on a scale||Standard Error|Mean
1258181|NCT00445744|Primary|Non-relapse Mortality (NRM) (Patients With AML/MDS)|Cumulative incidence rate with death as a competing risk, assessed at day 100.|Up to day 200||||percent|||Number
1258182|NCT00445744|Primary|Effectiveness of Cyclophosphamide/Busulfan Regimen in Reducing Regimen-related Liver Toxicity|Number of patients with regimen-related liver toxicity. Diagnoses will be made according to the established criteria initially proposed in 1984 by McDonald et al.|Up to day +20||||Participants|||Count of Participants
1258183|NCT00445705|Secondary|Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4|PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: “improved”= score of 1-3; “no change”=score of 4; and “worse”=score of 5-7.|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all randomized patients who started study (randomized) and who received the study medication with at least one post-treatment mean daily-average-pain score.|||Percentage of Patients|||Number
1258184|NCT00445705|Secondary|Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4|Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.|||Scores on a Scale||Standard Deviation|Mean
1258185|NCT00445705|Secondary|Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4|Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The “average pain” question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.|||Scores on a Scale||Standard Deviation|Mean
1258186|NCT00445705|Primary|Change From Baseline in Mean Daily-Average-Pain Score at Week 4|Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.|||Scores on a Scale||Standard Deviation|Mean
1258187|NCT00445692|Secondary|Survival|number of patients alive or dead|From date of transplant until the date of death from any cause, assessed up to 10.25 years||||Participants|||Count of Participants
1258188|NCT00445692|Primary|Time to Disease Progression||Up to 10.25 years|Measured among the 20 patients who progressed|||months||Full Range|Median
1258189|NCT00445692|Primary|Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3||First year of therapy||||episodes|||Number
1258190|NCT00445679|Secondary|Covi Anxiety Scale Score Mean Change From Baseline|Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||scores on a scale||95% Confidence Interval|Mean
1267504|NCT00380250|Secondary|Month 2 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
1258191|NCT00445679|Secondary|Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline|HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||scores on a scale||95% Confidence Interval|Mean
1258192|NCT00445679|Secondary|Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline|The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject’s assessment of an improvement in pain.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||scores on a scale||95% Confidence Interval|Mean
1258193|NCT00445679|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and 8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||units on a scale||95% Confidence Interval|Mean
1258194|NCT00445679|Secondary|Clinical Global Impressions Scale–Severity of Illness (CGI-S) Scores|CGI-S is a global rating scale that measures the severity of a subject’s disease. Using a 7-point scale, the clinician rates the severity of the patient’s mental illness at the time of the assessment, relative to the clinician’s experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||subjects|||Number
1258195|NCT00445679|Secondary|Clinical Global Impressions Scale–Improvement (CGI-I) Scores|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||subjects|||Number
1258196|NCT00445679|Primary|Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.|||percentage of responders|||Number
1258197|NCT00445601|Secondary|Rate of Disease Worsening Over 2 Years|Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.|Up to 2 years|TURBT data after patients stopped trial was not collected.||||||
1258198|NCT00445601|Secondary|Compare Qualitative and Quantitative Toxicities Between the Treatment Arms|Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug|Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT)|All eligible patients who received instillation after TURBT and reported adverse events|||Participants|||Number
1258199|NCT00445601|Secondary|Rate of Progression to Muscle Invasive Disease at 4 Years|From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression.|4 years|Intent-to-Treat Population|||percentage of patients with progression|||Number
1258200|NCT00445601|Primary|Disease Recurrence Rate|Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.|Up to 2 Years|Intent-to-Treat population|||percentage of patients with recurrence|||Number
1258201|NCT00445588|Secondary|6months -Progression-free Survival Rate|defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up|At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up||||percentage of participants||95% Confidence Interval|Number
1258202|NCT00445588|Primary|Overall Survival|death. measured by time of first day of treatment until date of death, assessed up to 2 years.|Time of first day of the treatment to death, assessed up to 2 years||||months||95% Confidence Interval|Median
1258203|NCT00445549|Secondary|The Number of Participants With Adverse Events|Here are the total # of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|22 months||||Participants|||Number
1258204|NCT00445549|Primary|Number of Participants With Clinical Efficacy|Defined as complete response (CR), partial response (PR), or disease stabilization lasting 6 months or longer per RECIST criteria. CR-total disappearance of all evaluable disease. PR->30% reduction in the sum of the longest diameters (LD) of target lesions. Stable disease (SD) is <30% decrease and <20% increase in the sum of the LD of all target lesions. See the protocol Link module for full RECIST criteria.|24 weeks||||participants|||Number
1258208|NCT00445484|Primary|6B Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.|||fold change||Standard Error|Mean
1258209|NCT00445458|Secondary|Area Under the Concentration-time Curve 0-24|Area under the concentration-time curve of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.|Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1258210|NCT00445458|Secondary|Maximum Plasma Concentration of Neratinib|Maximum plasma concentration of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.|Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1258211|NCT00445458|Primary|Objective Response Rate|Subjects with partial response (PR) or complete response (CR) with ERBB2 positive breast cancer treated at the maximum tolerated dose (MTD) of neratinib in combination with paclitaxel, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and no progressive disease (PD) for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to 140 weeks|All subjects, in Study part 2 evaluable population, who met the inclusion/exclusion criteria, received at least 2 weeks of neratinib and at least 2 doses of paclitaxel, and underwent at least 1 post-Baseline tumor assessment. Subjects who died or had symptomatic deterioration before the first scheduled post-Baseline tumor assessment were included.|||percentage of participants||95% Confidence Interval|Number
1258212|NCT00445458|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with paclitaxel 80 mg/m², intravenous at days 1, 8, and 15, associated with the dose limiting toxicity data.|From first dose date through day 28.|Safety population of Study Part 1. Treated set including patients eligible for MTD determination.|||mg|||Number
1258213|NCT00445458|Primary|Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel|Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.|From first dose date through day 28|Safety population of Study Part 1. Treated set including patients eligible for MTD determination.|||Participants|||Count of Participants
1258214|NCT00445432|Other Pre-specified|Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148|The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
1258215|NCT00445432|Other Pre-specified|Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148|The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 to 100, with 0=Poorest Health and 100=Best Health.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
1258216|NCT00445432|Other Pre-specified|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 148|"IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period with 32 questions about bowel function and related symptoms & their social/emotional impact. Per item, participants select 1 of 7 responses (1=poor quality of life [e.g., feeling of fatigue all of the time]; 7=good quality [e.g., feeling of fatigue none of the time]). Scoring range=32 to 224. Higher scores indicate better quality of life; increases in IBDQ=improved overall quality of life."|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
1258217|NCT00445432|Other Pre-specified|Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 148|The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
1258218|NCT00445432|Other Pre-specified|Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 148|Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/apthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >=0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
1289134|NCT00135707|Secondary|Premature Rupture of Membranes||During pregnancy||||Participants|||Count of Participants
1258219|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||participants|||Number
1258220|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||participants|||Number
1258221|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Remission at Week 148|Clinical remission = Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||participants|||Number
1258222|NCT00445432|Secondary|Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
1258223|NCT00445432|Secondary|Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (Poorest Health) to 100 (Best Health).|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
1258224|NCT00445432|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality (e.g., feeling of fatigue none of the time). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life."|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
1258225|NCT00445432|Secondary|Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
1258236|NCT00445328|Secondary|Bleeding - Major or Minor|Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.|Day 21|Intent to treat (ITT)|||participants|||Number
1258237|NCT00445328|Secondary|Stroke - Ischemic or Hemorrhagic|Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography|Day 21|Intent to treat (ITT)|||participants|||Number
1258226|NCT00445432|Secondary|Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment|Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of open-label treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug). Last observation carried forward (LOCF) used for missing data.|||Participants|||Number
1258227|NCT00445432|Secondary|Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
1258228|NCT00445432|Secondary|Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of double-blind treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab (not placebo) during adalimumab induction study and who received >= 1 dose of DB study drug during this study). NRI (CR-100 not achieved) used for missing data for DB treatments; LOCF for OL treatment.|||Participants|||Number
1258229|NCT00445432|Secondary|Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of double-blind treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab [not placebo] during adalimumab induction study and who received >= 1 dose of DB study drug during this study). Nonresponder imputation (NRI) (CR-70 not achieved) used for DB treatments; LOCF for OL treatment.|||Participants|||Number
1258230|NCT00445432|Primary|Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment|Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.|Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.|||Participants|||Number
1258231|NCT00445341|Primary|Response Rate (Complete Response (CR) and Partial Response (PR))|Response was assessed by the Cheson criteria. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g.(LDH) definitely assignable to the lymphoma. All lymph nodes must have regressed to normal size (</= 1.5 cm in greatest diameter if > 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to </= 1 cm or by more than 75% in the sum of the products of the greatest diameters (SPD). Spleen, if considered to be enlarged before therapy, must have regressed in size. Partial response is a >/= 50% decrease in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >/= 50% in the SPD. Bone marrow is irrelevant for determination of a PR.|2/16/2007 - 1/20/2011||||Participants|||Count of Participants
1258232|NCT00445341|Primary|Number of Participants With Adverse Events (e.g. Toxicity)|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|47 months||||Participants|||Count of Participants
1258233|NCT00445328|Secondary|Thrombocytopenia|Subjects with thrombocytopenia (low platelets).|Day 21|Intent to Treat (ITT)|||participants|||Number
1258234|NCT00445328|Primary|Composite of Objectively Verified Thromboembolic Events|Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.|Day 21|Intent to treat (ITT)|||participants|||Number
1258235|NCT00445328|Secondary|Allergic Reactions (Drug-related)|Subjects with drug-related allergic reactions|Day 21|Intent to treat (ITT)|||participants|||Number
1258239|NCT00445328|Primary|Confirmed Thromboembolic Events|Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.|Day 21|Intent to treat (ITT) set: all subjects who were randomized, received at least 1 dose of study drug and had undergone at least 1 test of primary efficacy assessment.|||participants|||Number
1258240|NCT00445315|Secondary|Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554||Screening up to Day 8|FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1258241|NCT00445315|Secondary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8|HCV RNA levels were determined using the Abbott RealTime HCV polymerase chain reaction (PCR) assay (lower limit of detection [LOD] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening Day 0 and Day 1 pre-dose measurements. The plasma HCV RNA data was log10 transformed, and the change in log10 HCV RNA at Day 8 post-dose from baseline was calculated.|Baseline, Day 8|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.|||log10 copies/mL||Standard Deviation|Mean
1258242|NCT00445315|Primary|Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|-24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
1258243|NCT00445315|Primary|Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|0 to 24 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
1258244|NCT00445315|Primary|Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|-24 to 0 hours (pre-dose) on Day 1 (Day 0)|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
1258245|NCT00445315|Primary|Renal Clearance (CLr): Day 8|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||mL/minute||Standard Deviation|Geometric Mean
1258246|NCT00445315|Primary|Renal Clearance (CLr): Day 1|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||mL/minute||Standard Deviation|Geometric Mean
1258247|NCT00445315|Primary|Percent of Dose Recovered Unchanged in Urine (Ae%): Day 8|Percent of dose recovered unchanged in urine during the dosing interval=100 (cumulative amount of drug recovered unchanged in urine [Ae] divided by dose), where the dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||percent dose recovered||Standard Deviation|Geometric Mean
1258248|NCT00445315|Primary|Percent of Dose Recovered Unchanged in Urine (Ae%): Day 1|Percent of dose recovered unchanged in urine during the dosing interval=100*(cumulative amount of drug recovered unchanged in urine [Ae] divided by dose), where the dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||percent dose recovered||Standard Deviation|Geometric Mean
1258249|NCT00445315|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||nanogram||Standard Deviation|Geometric Mean
1258250|NCT00445315|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||nanogram||Standard Deviation|Geometric Mean
1258251|NCT00445315|Primary|Observed Accumulation Ratio for Cmax (Rac Cmax)|Rac Cmax was calculated as, maximum observed plasma concentration on Day 8 (Cmax) divided by maximum observed plasma concentration on Day 1(Cmax).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
1258252|NCT00445315|Primary|Observed Accumulation Ratio (Rac)|Rac was calculated as, area under the curve from time zero to end of dosing interval on Day 8 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1(AUCtau).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
1258253|NCT00445315|Primary|Plasma Decay Half-Life (t1/2): Day 8|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. The t1/2 of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hour||Standard Deviation|Mean
1258254|NCT00445315|Primary|Minimum Observed Plasma Trough Concentration (Cmin): Day 8|The Cmin of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1258255|NCT00445315|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ng*hour/mL||Standard Deviation|Geometric Mean
1258256|NCT00445315|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 1|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ng*hour/mL||Standard Deviation|Geometric Mean
1258257|NCT00445315|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||hour||Full Range|Median
1258258|NCT00445315|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||hour||Full Range|Median
1258259|NCT00445315|Primary|Maximum Observed Plasma Concentration (Cmax): Day 8||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1258260|NCT00445315|Primary|Maximum Observed Plasma Concentration (Cmax): Day 1||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|Per Protocol (PP) analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the pharmacokinetics (PK) parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1258261|NCT00445302|Secondary|Number of Participants in Overall Safety Summary of Adverse Events (TEAE)|Number of participants with adverse events (AEs) collected from Day 1 (post plerixafor administration) to Day 3. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|up to Day 3|The safety analyses were performed on the Safety Population which consisted of all subjects who received plerixafor.|||participants|||Number
1258262|NCT00445302|Primary|Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h)|Evaluation of AUC0-24 hour following a single dose of 240 µg/kg plerixafor administered on Day 1. AUC0-24 was normalized by dose.|Pre-dose of plerixafor to 24 hours post-plerixafor|Intent-to-treat population|||hr*ng/mL/ug||Standard Deviation|Mean
1258263|NCT00445302|Secondary|Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2|Change in absolute white blood cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = absolute white blood cells at 24 hours post dose - absolute white blood cells at Baseline.|Baseline and Day 2|An intent-to-treat approach was used to calculate the outcome measure in each arm/group.|||cells/mm^3||Standard Deviation|Mean
1258264|NCT00445302|Secondary|Change From Baseline in Absolute CD34+ Cell Counts at Day 2|Change in circulating CD34+ cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = CD34+ cell count at 24 hours post dose - CD34+ cell count at Baseline.|Baseline, Day 2|An intent-to-treat approach was used to calculate the outcome measure in each arm/group.|||cells/mm^3||Standard Deviation|Mean
1289135|NCT00135707|Secondary|Antepartum Bleeding||During pregnancy||||Participants|||Count of Participants
1258279|NCT00445211|Primary|Major Bleeding During the Index Hospitalization|Count of participants with hemorrhage associated with at least one of the following features as defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria: Bleeding that results in a decrease in hemoglobin >/= 5g.dL or a hematocrit decrease of >/= 15% of baseline value; bleeding that is intracranial (confirmed by MRI or CT); bleeding that results in death.|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients|||Participants|||Count of Participants
1258280|NCT00445211|Primary|Major Ischemia (Decreased Blood Flow) During the Index Hospitalization|Count of participants with loss of Doppler signal or sensation or abnormal skin temperature, mottling or pallor in lower extremity requiring surgical intervention; or other major ischemic events including ischemic stroke; recurrent unstable ischemia (unstable angina, recurrent chest pain prompting definitive treatment such as re-percutaneous transluminal coronary angiography (PTCA), coronary artery bypass grafting (CABG), administration of thrombolytics); reinfarction including clinical symptoms or new ECG changes with creatine kinase (CK) elevation and positive creatine kinase-MB isoenzyme fraction; arterial thrombosis, embolus, dissection, or perforation; compartment syndrome; renal ischemia including new renal failure or need for dialysis; small bowel or splenic infarction; mesenteric or hepatic ischemia, or deep vein thrombosis.|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients|||Participants|||Count of Participants
1258281|NCT00445211|Primary|Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization|Count of participants with decreased arterial flow in lower extremity as presented by diminished pulse that resolves with balloon removal, and not resulting in any impairment of body function|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients|||Participants|||Count of Participants
1258282|NCT00445146|Secondary|Incidence of Mortality|The percentage of participants who died was summarized.|Up to Week 408 plus 30 days|Safety Analysis Set|||percentage of participants|||Number
1258283|NCT00445146|Secondary|CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed.|||cells/mm^3||Standard Deviation|Mean
1258284|NCT00445146|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage of participants|||Number
1258285|NCT00445146|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage of participants|||Number
1258286|NCT00445146|Secondary|HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1258287|NCT00445146|Secondary|Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||U/L||Standard Deviation|Mean
1258288|NCT00445146|Secondary|Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||U/L||Standard Deviation|Mean
1258289|NCT00445146|Secondary|Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||U/L||Standard Deviation|Mean
1258290|NCT00445146|Secondary|Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||10^3 cells/µL||Standard Deviation|Mean
1258291|NCT00445146|Secondary|White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||10^3 cells/μL||Standard Deviation|Mean
1258292|NCT00445146|Secondary|Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||10^6 cells/μL||Standard Deviation|Mean
1258293|NCT00445146|Secondary|Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||g/dL||Standard Deviation|Mean
1258294|NCT00445146|Secondary|Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality|A 'marked abnormality’ was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.|Up to Week 408 plus 30 days|Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.|||percentage of participants|||Number
1258295|NCT00445146|Secondary|Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.|Up to Week 408 plus 30 days|Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.|||percentage of participants|||Number
1267505|NCT00380250|Secondary|Month 3 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 3|ITT with LOCF|||Scale score||Standard Deviation|Mean
1258296|NCT00445146|Secondary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events|Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Up to Week 408 plus 30 days|Safety Analysis Set|||percentage of participants|||Number
1258297|NCT00445146|Primary|Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event||Up to Week 408 plus 30 days|Safety Analysis Set: enrolled participants who received at least 1 dose of EVG|||percentage of participants|||Number
1258298|NCT00445003|Secondary|Change in Optical Coherence Tomography Retinal Volume|Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively|Baseline to 14 weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||mm^3||Standard Deviation|Mean
1258299|NCT00445003|Secondary|Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema|Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.|14 weeks to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||Eyes|||Number
1258300|NCT00445003|Secondary|Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema||14 weeks to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||Eyes|||Number
1258301|NCT00445003|Secondary|Change in Visual Acuity From Baseline|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||Letter Score||Standard Deviation|Mean
1258302|NCT00445003|Secondary|Total Optical Coherence Tomography Retinal Volume|Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.|Baseline to 14-weeks|Participants with 2 study eyes enrolled each eye in a different arm. Therefore, each arm includes no more than 1 eye for a given participant, and thus the numbers of eyes is equal to number of participants.|||mm^3||Standard Deviation|Mean
1258303|NCT00445003|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness||Baseline to 14 weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||Microns||Inter-Quartile Range|Median
1258304|NCT00445003|Secondary|Additional Treatments for Diabetic Macular Edema|Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.|14 weeks to 56-weeks||||Eyes|||Number
1258305|NCT00445003|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 14 weeks|Participants with 2 study eyes enrolled each eye in a different arm. Each arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. Analysis followed intention to treat principle; eyes without 14-week data, the Last Observation Carried Forward method was used.|||Letter Score||Standard Deviation|Mean
1258306|NCT00444951|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination||Day 0 to Day 7 Post-vaccination|Safety analysis was on all vaccinated participants, intend-to-treat population (Safety analysis set)|||Participants|||Number
1258307|NCT00444951|Secondary|Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination||Baseline (Day 0) and Day 28 After Vaccination|4-Fold rise titers were determined in the per-protocol population.|||Percentage of Participants|||Number
1258308|NCT00444951|Primary|Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination||Baseline (Day 0) and Day 28 after vaccination|Geometric mean titers were evaluated in participants who received vaccine injection (full analysis set population).|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
1258309|NCT00444925|Post-Hoc|Diary Dry Rates|Diary dry rate: number of subjects with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Week 1, Week 4, Week 12|FAS; only subjects with baseline urgency urinary incontinence >0 per 24 hours are included; n=number of subjects in the respective category at observation (Week 1, Week 4, Week 12).|||participants|||Number
1258310|NCT00444925|Secondary|Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).|HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.|Baseline, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo, Tolterodine ER, and Fesoterodine, respectively.|||score on scale||Standard Error|Least Squares Mean
1258311|NCT00444925|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).|Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.|Baseline, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo n=289; Tolterodine ER n=589; Fesoterodine n=571.|||score on scale||Standard Error|Least Squares Mean
1258312|NCT00444925|Secondary|Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.|Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||participants|||Number
1258313|NCT00444925|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC).|Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||participants|||Number
1258314|NCT00444925|Secondary|Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.|Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||score on scale||Standard Error|Least Squares Mean
1258315|NCT00444925|Secondary|Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.|Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||score on scale||Standard Error|Least Squares Mean
1258316|NCT00444925|Secondary|Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.|Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
1258317|NCT00444925|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.|Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||severe urgency episodes per 24 hours||Standard Error|Least Squares Mean
1258318|NCT00444925|Secondary|Percent Change From Baseline of Urgency Episodes Per 24 Hours.|Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
1258319|NCT00444925|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.|Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||urgency episodes per 24 hours||Standard Error|Least Squares Mean
1258332|NCT00444912|Secondary|Median Number of Days to Lymphocyte Engraftment|Median number of days from transplantation to lymphocyte engraftment which was defined as lymphocyte counts ≥5*10^8/L. Time to engraftment corresponded to the first day that criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had lymphocyte engraftment.|||days||Full Range|Median
1258320|NCT00444925|Secondary|Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
1258321|NCT00444925|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.|Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||nocturnal micturitions per 24 hours||Standard Error|Least Squares Mean
1258322|NCT00444925|Secondary|Percent Change From Baseline of Micturitions Per 24 Hours.|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
1258323|NCT00444925|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours.|The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||number of micturitions per 24 hours||Standard Error|Least Squares Mean
1258324|NCT00444925|Secondary|Change From Baseline in Mean Voided Volume Per Micturition.|Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||voided volume per micturition||Standard Error|Least Squares Mean
1258325|NCT00444925|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours.|UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
1258326|NCT00444925|Secondary|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.|UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [Last Observation Carried Forward (LOCF)]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||number of episodes per 24 hours||Standard Error|Mean
1258327|NCT00444925|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).|UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.|Baseline, Week 12|Full analysis set (FAS): took at least 1 dose of assigned treatment, contributed data to at least 1 baseline or post-baseline efficacy assessment, and excluded 107 subjects from two study sites with significant Good Clinical Practices (GCP) deviations. The decision to exclude that data was made while the study was still blinded.|||number of episodes per 24 hours||Standard Error|Mean
1258328|NCT00444912|Secondary|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Evaluable population of participants who received a stem cell transplant and had a 12-month assessment.|||participants|||Number
1258329|NCT00444912|Secondary|The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day||Day 5|Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.|||percentage of total cells||Full Range|Median
1258330|NCT00444912|Secondary|Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant||13 months (12 months post-transplant)|Evaluable population of participants who received a stem cell transplant and had assessment performed 12 months post-transplant.|||cells / μL||Full Range|Median
1258331|NCT00444912|Secondary|Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant||Approximately 7 months (6 months post-transplant)|Evaluable population of participants who received a stem cell transplant and had assessment performed 6 months post-transplant.|||cells / μL||Full Range|Median
1258468|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258333|NCT00444912|Secondary|Median Number of Days to Platelet (PLT) Engraftment|Median number of days from transplantation to PLT engraftment which was defined as platelet counts ≥20*10^9/L without transfusion for the preceding 7 days or platelet counts ≥50*10^9/L for one day. Time to engraftment corresponded to the first day that the criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had PLT engraftment.|||days||Full Range|Median
1258334|NCT00444912|Secondary|Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|Median number of days from transplantation to PMN engraftment which was defined as PMN counts ≥0.5*10^9/L for 3 consecutive days or ≥1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had PMN engraftment|||days||Full Range|Median
1258335|NCT00444912|Secondary|Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg|Median number of apheresis days in each treatment arm to reach the target of 5*10^6 CD34+ cells/kg.|Days 5-8|Evaluable population of participants who achieved ≥5*10^cells/kg collected during apheresis.|||days||Full Range|Median
1258336|NCT00444912|Secondary|Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg|Median number of apheresis days in each treatment arm to collect a minimum of 3*10^6 CD34+ cells/kg.|Days 5-8|Evaluable population of participants who achieved ≥3*10^cells/kg collected during apheresis.|||days||Full Range|Median
1258337|NCT00444912|Secondary|Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration|Fold Increase = (Pre-Apheresis CD34+ cells/Pre-Plerixafor CD34+ cells).|Days 4-5|Evaluable population of participants with peripheral blood CD34+ measurements on Days 4 and 5.|||fold increase||Full Range|Median
1258338|NCT00444912|Secondary|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median total number of CD34+ cells collected during apheresis.|Days 5-8|Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.|||CD34+ cells (*10^6 / kg)||Full Range|Median
1258339|NCT00444912|Primary|Summary of Adverse Events (AEs)|Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.|Day 1 and up to Day 59 (maximum time before start of chemotherapy)|Safety Population: all participants who received at least 1 dose of study drug (G-CSF, plerixafor, or rituximab)|||participants|||Number
1258340|NCT00444821|Secondary|Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up|secondary interventions in those that had successful delivery and deployment by treatment group randomized to.|study termination|Study was terminated before all subjects enrolled and completed follow-up.|||Participants|||Count of Participants
1258341|NCT00444821|Secondary|Aneurysm Growth >0.5 cm|After repair, AAA enlargement by >0.5cm|1 year|Study was terminated before all subjects enrolled and completed follow-up.|||Participants|||Count of Participants
1258342|NCT00444821|Primary|Number of Subjects That Experienced Rupture or Aneurysm Related Death||3 years|Study was terminated before all subjects enrolled and completed follow-up.|||Participants|||Count of Participants
1258343|NCT00444795|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST)|The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.|At the end of study treatment, average of 23.2 weeks.|Intent-to-treat Analysis Set: Participants who administered Sutene at least once.|||Percentage of Participants||95% Confidence Interval|Number
1258344|NCT00444795|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs|An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely” or “no” (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.|From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.|Safety Analysis Set|||Percentage of Participants||95% Confidence Interval|Number
1258345|NCT00444626|Secondary|Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period|"Count of participants with treatment-emergent adverse events (AEs) from the time of injection for the repeat treatment period up to week 47. AEs are presented regardless of relationship to study device and/or procedure.~If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive."|weeks 36 up to 47 weeks|Safety Population for repeat treatment.|||Participants|||Number
1258359|NCT00444600|Other Pre-specified|Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year|113 eyes had missing or ungradable photos at 1 year. Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833|from baseline to 1 Year||||Eyes|Participants||Number
1258346|NCT00444626|Secondary|Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period|"Counts of participants with treatment-emergent adverse events (AEs) from the time of injection up to Week 36. AEs are presented regardless of relationship to study device and/or procedure.~If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive."|Weeks 1-36|Number of patients randomized to initial treatment phase. Safety Population.|||Participants|||Number
1258347|NCT00444626|Secondary|Participant Product Preference at Week 36|Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC).|Week 36|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Participants|||Number
1258348|NCT00444626|Secondary|Participant Product Preference at Week 24|Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC).|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Participants|||Number
1258349|NCT00444626|Secondary|Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator’s Assessment of Wrinkle Severity at Week 24|Count of participants with at least a 1-point improvement from Baseline in the Genzyme 6-Point Grading Scale (GGS) at Week 24. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Participants|||Number
1258350|NCT00444626|Secondary|Change From Baseline in the Blinded Evaluator’s Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36|"Mean change between Baseline and the Week 36 score (Baseline minus week 36 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.~Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds."|Week 36|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Units on a scale|Participants|Standard Deviation|Mean
1258351|NCT00444626|Secondary|Participant’s Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)|The pain experienced by each participant at the time of injection (time 0) and at 15 and 30 minutes after injection during the initial treatment visit was evaluated. Pain was measured using a VAS of 0 mm (no pain) to 100 mm (extreme pain).|Day 1|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Units on a scale||Standard Deviation|Mean
1258352|NCT00444626|Primary|Change From Baseline in the Blinded Evaluator’s Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24|"This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.~Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds."|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Units on a scale|Participants|Standard Deviation|Mean
1258353|NCT00444600|Other Pre-specified|Major Ocular Adverse Events During First Year of Follow-Up||1 Year||||Eyes|Participants||Number
1258354|NCT00444600|Secondary|Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year||from baseline to 1 Year||||mm^3|Participants|Standard Deviation|Mean
1258355|NCT00444600|Secondary|Mean Optical Coherence Tomography Retinal Volume at 1 Year||1 Year||||mm^3|Participants|Standard Deviation|Mean
1258356|NCT00444600|Other Pre-specified|Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year|Antiplatelet Trialists' Collaboration is a collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. MBJ 1994; 308:81-106. Nonfatal cerebrovascular accident includes ischemic or hemorrhagic or unknown events. Vascular death includes death from any potential vascular or unknown cause.|1 Year|Study participants with 2 study eyes are assigned to the non-sham group. Multiple events within a study participant are only counted once per event.|||Participants|||Number
1258357|NCT00444600|Secondary|Percentage of Eyes Receiving Laser at the 48 Week Visit (%)||1 Year||||Eyes|Participants||Number
1258358|NCT00444600|Other Pre-specified|Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year|Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833, ETDRS Severity Scale = Diabetic retinopathy absent, minimal non-proliferative diabetic retinopathy (PDR), mild to moderately severe non-PDR, severe non-PDR, scars of full pr partial panretinal photocoagulation present PDR absent, mild to moderate PDR, high risk PDR, cannot grade, missing.|from baseline to 1 Year||||Eyes|Participants||Number
1258360|NCT00444600|Other Pre-specified|Eyes With Alternative Treatments Prior to the 1-year Visit|Each combination of treatment only counted once.|1 Year||||Eyes|Participants||Number
1258361|NCT00444600|Secondary|Number of Laser Treatments Received Prior to the 1 Year Visit|One eye in the sham+prompt laser group did not receive laser until post 1-year due to an adverse event unrelated to study treatment. One eye in the triamcinolone+prompt laser did not receive laser until after 1-year due to missing 2 consecutive visits at the time of required laser treatment.|1 Year|Number who completed the 1-year visit.|||Eyes|Participants||Number
1258362|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year||||Letters|Participants|Standard Deviation|Mean
1258363|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year||||Letters|Participants|Standard Deviation|Mean
1258364|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year||||Letters|Participants|Standard Deviation|Mean
1258365|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year||||Letters||Standard Deviation|Mean
1258366|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema||from baseline to 1 Year||||Letters||Standard Deviation|Mean
1258367|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline||from baseline to 1 Year||||Letters|Participants|Standard Deviation|Mean
1258368|NCT00444600|Other Pre-specified|Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening|Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.|1 Year||||Eyes|Participants||Number
1258369|NCT00444600|Other Pre-specified|Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year||1 Year||||Eyes|Participants||Number
1258370|NCT00444600|Primary|Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|from baseline to 1 Year|For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis.|||Eyes|Participants||Number
1258371|NCT00444600|Primary|Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis. followed intention to treat principle.|||Letters|Participants|Standard Deviation|Mean
1258372|NCT00444600|Secondary|Number of Injections in First Year|Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections.|from baseline to 1 year|Sham+prompt laser group listed median excludes 56 eyes among 163 participants with 2 study eyes that were unmasked at baseline because the participant's other eye was in the ranibizumab+deferred laser group, precluding sham injections for the study eye assigned to sham+prompt laser.|||Injections|Participants|Inter-Quartile Range|Median
1258373|NCT00444600|Secondary|Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year|Negative change denotes an improvement.|from baseline to 1 year||||microns|Participants|Standard Deviation|Mean
1258374|NCT00444587|Secondary|Mean Left Ventricular Ejection Fraction|Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat. It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).|Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||percent of blood pumped from LV chamber]||Standard Deviation|Mean
1258375|NCT00444587|Secondary|Hematology Safety Laboratory Parameter: Mean Platelets Counts|Participants in the study were evaluated for the platelets at Visit 1 and final study assessments. Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||Number of cells x 10^9/L||Standard Deviation|Mean
1258411|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire|"May be used to offer patients a strategy of treatment during the initial phase and in the long term.~Not done"|Day 0|The results of exploratory analyses are not available.||||||
1258376|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts|"Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments.~Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice."|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||percent of differential||Standard Deviation|Mean
1258377|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts|Participants in the study were evaluated for the total leukocytes up to 5 years. Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||10^9 leukocytes/L||Standard Deviation|Mean
1258378|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels|Participants in the study were evaluated for the Hemoglobin up to 5 years. Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||grams per deciliter||Standard Deviation|Mean
1258379|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels|Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium. Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||Millimole per liter||Standard Deviation|Mean
1258380|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Albumin Levels|Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments. Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||gram per liter||Standard Deviation|Mean
1258381|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels|Participants in the study were evaluated for the total bilirubin and serum creatinine. Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||Micromole/liter||Standard Deviation|Mean
1258382|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels|Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years). Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||Units per liter||Standard Deviation|Mean
1258383|NCT00444587|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 5 years|The Safety Population included all participants who entered the trial and received at least one dose of trial medication.|||Number of participants|||Number
1258384|NCT00444587|Secondary|Overall Survival|Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause. Overall survival was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants with data available were analyzed.|||Days||95% Confidence Interval|Median
1258412|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire|May be used to evaluate the severity of symptoms during the initial visit. Not done|Day 0|The results of exploratory analyses are not available.||||||
1258469|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258385|NCT00444587|Secondary|Median Time to Treatment Failure|Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death. Median time to treatment failure was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants who experienced treatment failure were analyzed.|||Days||95% Confidence Interval|Median
1258386|NCT00444587|Secondary|Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments. CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : >=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease. It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator. CBR was also assessed by computer. Clinical benefit rate was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set participants with measurable disease with CR, PR and SD. Study design was changed to single arm study because herceptin use after progression herceptin-based therapy become widespread.|||Percentage of participants||95% Confidence Interval|Number
1258387|NCT00444587|Secondary|Objective Response Rate|Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount. It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0. Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions. Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. Objective response rate was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set participants with measurable disease with CR or PR|||Percentage of participants||95% Confidence Interval|Number
1258388|NCT00444587|Primary|Median Time to Disease Progression|Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. n = Numbers of participants included in this analysis.|||Days||95% Confidence Interval|Median
1258389|NCT00444535|Secondary|Progression-free Survival|Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.|Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population|||weeks||95% Confidence Interval|Median
1258390|NCT00444535|Secondary|Clinical Benefit|Clinical benefit is defined as defined as the percentage of participants with evidence of a confirmed CR (complete resolution of lesions observed at baseline) or PR (30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) at any time or stable disease (insufficient response to qualify for CR or PR, and insufficient increase in tumor burden to qualify for progressive disease [20% increase in sum of longest diameters, new lesions, or symptomatic progression]) for at least 24 weeks per RECIST.|Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population|||Percentage of participants|||Number
1258391|NCT00444535|Secondary|Overall Response|The percentage of participants with measurable disease with a best response of partial response (PR, 30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) or complete response (CR, complete resolution of lesions observed at baseline) per RECIST was measured. The first assessment of overall response was at Week6; however, the participants were assessed for response until treatment ended.|Week 6 through End of Study (until end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population. Analysis was done on 45 of 52 participants, as 7 participants had withdrawn before Week 6.|||Percentage of participants|||Number
1258392|NCT00444535|Primary|Percentage of Participants Reaching Week 12 Without Disease Progression|The progression-free survival rate was evaluated by the investigator after 12 weeks of treatment and was defined as the number of participants with no evidence of disease progression (20% increase in sum of longest diameters, new lesions, or symptomatic progression) per Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause for a minimum of 84 days (12 weeks).|Week 12|Intent-to-Treat (ITT) Population: all enrolled participants, regardless of whether or not they received any study medication|||Percentage of participants|||Number
1258413|NCT00444275|Secondary|Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study|Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.|12 weeks - maintenance treatment phase||||Participants|||Number
1258470|NCT00443729|Secondary|Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258393|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.|||percentage of participants|||Number
1258394|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
1258395|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
1258396|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
1258397|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.|||percentage of participants|||Number
1258398|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
1258399|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
1258400|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
1258401|NCT00444457|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.|||GMC mcg/mL||95% Confidence Interval|Geometric Mean
1258402|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.|||observed percentage of participants||95% Confidence Interval|Number
1258403|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.|||observed percentage of participants||95% Confidence Interval|Number
1258404|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.|||observed percentage of participants||95% Confidence Interval|Number
1258405|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.|||observed percentage of participants||95% Confidence Interval|Number
1258406|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.|||observed percentage of participants||95% Confidence Interval|Number
1258407|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component; n)=number of participants with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.|||observed percentage of participants||95% Confidence Interval|Number
1258408|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population. Combined 13vPnC group includes participants who received pilot lot 1, pilot lot 2, or manufacturing lot; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.|||observed percentage of participants||95% Confidence Interval|Number
1258409|NCT00444457|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 Month after the infant series (7 Months of age)|Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations; (n)=number of participants with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.|||GMC mcg/mL||95% Confidence Interval|Geometric Mean
1258410|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)|May be used to define the success of treatment. Not done|Week 4|The results of exploratory analyses are not available.||||||
1258414|NCT00444275|Secondary|Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment|Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ [8-10] : possible anxiety-depression/ >10 : anxiety-depression)|16 weeks||||Percent of participants with failure|||Number
1258415|NCT00444275|Secondary|Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)|Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never)|4 to 16 weeks|871 (-66 missing data, 801 (-56 missing data), 833 (-75 missing data)|||Scores on scale||Standard Deviation|Mean
1258416|NCT00444275|Secondary|Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase|No possibility to describe as only 2 patients took ASA|4 weeks|Outcome measure not possible to describe as only 2 patients took Aspirin.||||||
1258417|NCT00444275|Secondary|Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).|"Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator.~The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From Never for the Lowest Frequency to Every Day for the Highest, 6 Others Assess the Severity of Symptoms From Not at All to Strong. The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item."|4 weeks||||Percentage of participants|||Number
1258418|NCT00444275|Primary|Efficacy of Three Strategies of Long-term Treatment|Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?|16 weeks||||Percentage of participants with failure|||Number
1258419|NCT00444145|Primary|Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy|Dilation of inter cellular spaces (the space within the cell) is reported to be an early morphological (structure and form) marker in gastro-oesophageal reflux. Using electron microscopy, the distance between epithelial cells is quantified.|3 months||||participants|||Number
1258420|NCT00444106|Secondary|Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42|Percentage of patients with clearance of asexual parasitemia (observed by optical microscopy) within 7 days of initiation of trial treatment without recrudescence within 14, 28 and 42 days respectively after initiation of treatment. Patients with recurrent parasitemia and paired PCR results were classified as either a new infection (different paired genotypes) or a recrudescence (matching paired genotypes). Patients without paired PCR results or ambiguous results were classified as treatment failures.|Days 14, 28 and 42|Full Analysis Set defined as all randomized patients with confirmed malaria at baseline, who had at least one dose of study drug and had at least one relevant post-baseline efficacy assessment.|||Percentage of Participants||95% Confidence Interval|Number
1258421|NCT00444106|Secondary|Relationship Between Changes in Auditory Function and Treatment Groups|ABR Wave III latency (ms) changes from baseline to Day 7 in the three drug exposure groups.|From Baseline to Day 7||||ms||95% Confidence Interval|Mean
1258422|NCT00444106|Secondary|Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test)|Audiometric measurements such as pure-tone threshold (air conduction tested at 250 to 8000 HZ) day 3, 7, 28 and 42 following initiation of treatment, including changes from baseline. Pure-tone average (PTA) calculated for each ear by averaging the pure-tone threshold values at 500, 1000, 2000 and 3000 HZ.|Baseline (Day 1), 3, 7, 28 and Day 42|Safety per protocol patients who had a valid ABR at baseline and on the specified day were included.|||dB||95% Confidence Interval|Mean
1258423|NCT00444106|Primary|Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)|"To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An auditory nerve abnormality is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups."|7 days|Safety per protocol set defined as all the randomized patients who took at least 80% of the entire recommended dose and had a valid baseline and Day 7 ABR Wave III latency evaluation and did not use any meds having an ototoxic effect.|||Percentage of Participants||95% Confidence Interval|Number
1258424|NCT00444067|Other Pre-specified|Incidence of Post-Operative Surgical Site Infections (SSIs)|"•Percentage of participants who incur an SSI within 90 days post-procedure determined by clinical diagnosis~SSIs were diagnosed and classified in accordance with the Centers for Disease Control (CDC) criteria for evaluation and diagnosis of nosocomial surgical site infections and were classified as one of the following (Superficial, Deep or Organ/Space)."|90 Days|Fisher’s Exact Test was used to test for a difference in the proportions of subjects with SSIs between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.|||percentage of participants||95% Confidence Interval|Number
1258438|NCT00443872|Secondary|Beck Anxiety Inventory Scores for All Subjects|The Beck Anxiety Inventory is a general measure of anxiety. There are 21 questions each with responses ranging from 0 (no issue or problem) to 3 (severe - I could barely stand it), all questions are related to the presence of signs or symptoms of anxiety. The total possible score is 63 and a higher score represents greater anxiety. The total score is calculated by adding the responses for each of the 21 items.|Baseline and 3 months|All|||units on a scale||Standard Deviation|Mean
1289136|NCT00135707|Secondary|Creatinine ≥1.5 mg/dl (133 μmol/Liter)||20 weeks through discharge||||Participants|||Count of Participants
1258425|NCT00444067|Other Pre-specified|Incidence of Post-Operative CSF Leaks|"Percentage of participants with CSF leaks within 90 days post-operatively as determined from clinical diagnosis by one of the following methods:~CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 90 days post-procedure; or~CSF leak confirmation by diagnostic testing within 90 days post-procedure; or~CSF leak confirmation by clinical evaluation within 90 days post-procedure"|90 Days|Fisher’s Exact Test was used to test for a difference in the proportions of subjects with CSF leaks between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.|||percentage of participants||95% Confidence Interval|Number
1258426|NCT00444067|Primary|Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)|"Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as:~A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds."|Intra-operative|The primary analysis for the primary efficacy endpoint was performed using a two-sided Fisher’s Exact Test to test for a difference in the true success rates in obtaining a watertight closure between treatments.|||percentage of participants||95% Confidence Interval|Number
1258427|NCT00444028|Primary|Dose Proportionality (AUCinf) by Power Analysis|"Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||hr*mcg/L||Standard Deviation|Mean
1258428|NCT00444028|Primary|Cmax|maximum concentration of loxapine observed|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||ng/mL||Standard Deviation|Mean
1258429|NCT00444028|Primary|Clearance|clearance (CL/F) of lozxapine|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||L/hour||Standard Deviation|Mean
1258430|NCT00444028|Primary|ke|elimination rate constant|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||/hour||Standard Error|Mean
1258431|NCT00444028|Primary|Half-life|Half-life of the terminal elimination phase of loxapine concentrations|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||hours||Standard Deviation|Mean
1258432|NCT00444028|Primary|Tmax|Tmax = time from inhalation to to maximum observed loxapine concentration|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||minutes||Standard Deviation|Mean
1258433|NCT00443898|Secondary|Number of Participants Assessed With Adverse Events and Serious Adverse Events|"An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.~A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage."|52 weeks|Safety Population was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety assessment. All except 4 participants who were randomized to the vehicle 24 w group and one participant randomized to the terbinafine 48 w group, were included in the safety population.|||Participants|||Number
1258434|NCT00443898|Secondary|Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.|"Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.~Clinical effectiveness was a composite binary variable defined as~Yes” if~Mycological cure (negative KOH and negative culture for dermatophytes) and~= 10% residual involvement of the target toenail~No” if otherwise"|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).|||Percentage of Participants|||Number
1258435|NCT00443898|Secondary|Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.|"Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.~Mycological cure was a composite binary variable defined as~Yes”if :~Negative microscopy and~Negative culture for dermatophytes~No” if otherwise."|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).|||Percentage of Participants|||Number
1258436|NCT00443898|Primary|Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.|"Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.~and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as~Yes” if:~Mycological cure (negative KOH and negative culture for dermatophytes) and~No residual involvement of the target toenail~No” if otherwise"|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).|||Percentage of Participants|||Number
1258437|NCT00443872|Secondary|Mini Mental State Examination (MMSE) Scores for All Subjects|The MMSE is a general measure of cognition (i.e., measures attention, memory, visuospatial construction, etc). It has 30 items, each item representing 1 point. The total score ranges from 0-30 with 30 being a perfect score (no cognitive impairment) and 0 being the lowest score (greatest possible level of impairment). The total score is calculated by adding the scores of each item.|Baseline and 3 months|All|||units on a scale||Standard Deviation|Mean
1258439|NCT00443872|Secondary|Beck Depression Inventory for All Subjects|The Beck Depression Inventory is a general measure of depression. There are 21 questions each with responses ranging from 0 (no issue or problem) to 3 (maximum issue/distress), all questions are related to emotions, mood, feelings, etc. The total possible score is 63 (higher scores represent more depression). The total score is calculated by adding the scores of the 21 items.|Baseline and 3 months|All|||units on a scale||Standard Deviation|Mean
1258440|NCT00443872|Secondary|PDQ-39 Quality of Life Assessment Total Scores|The PDQ-39 is a measure of quality of life, it has 8 sub scales and a total score. For this study only the total score was examined. There are a total of 39 questions related to the following 8 sub scales: ability/difficulty to perform motor activities, ability to perform daily activities, cognition, emotional well being, stigma, social support, communication, bodily discomfort; each question with 5 responses (0, no/never, 4 always). The total score is calculated by adding the scores for each of the 39 items, dividing by 39 x 4 (maximum score for all 39 items) and then multiplying by 100 to get a percentage score ranging from 0-100 with 100 representing the most disability and greatest impact on quality of life.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1258441|NCT00443872|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Scores|"The UPDRS activities of daily living sub scale has 14 questions regarding the ability to perform daily activities like dressing, eating, etc. These questions are completed by the patient and each question has 5 responses ranging from 0 (no problems) to 4 (severe disability/cannot do). The total score for this sub scale is the sum of the scores for the 14 questions (higher scores represent greater disability), maximum score is 56.~The motor assessment is completed by the investigator. There are 14 questions evaluating motor function in various body parts, representing 27 individual items (i.e., some questions, such as rigidity, are rated for 5 different body parts, other questions, such as finger tapping, are rated on both the right and left sides, and other questions are rated individually). Each item has 5 responses, 0 being none/no disability and 4 being the most severe disability. The 27 items are summed (higher scores represent greater disability); maximum score is 108."|Baseline and 3 months|All subjects completing the study were included|||units on a scale||Standard Deviation|Mean
1258442|NCT00443872|Primary|Barratt Impulsiveness Scale Score for Those With Impulsive Behavior|This is a measure of impulsiveness. There are 30 questions regarding the presence of impulsive and non-impulsive behaviors each scored from 1 (rarely/never) to 4 (almost always/always). The total score reflects the sum of the 30 items. A higher score represents more impulsiveness.|Baseline and 3 months|The number with ICDs at baseline|||units on a scale||Standard Deviation|Mean
1258443|NCT00443872|Primary|Circumference of Lower Leg/Foot at Greatest Point of Swelling for Pedal Edema|The circumference of the lower leg/ankle with the greatest swelling was measured using a standard tape measure at baseline and 12 weeks for both the right and left ankles.|Baseline and 3 months|Presence of pedal edema at baseline|||centimeters||Standard Deviation|Mean
1258444|NCT00443872|Primary|Neuropsychiatric Inventory (NPI) Hallucinations Scale Score for Those With Hallucinations|Report of hallucinations with insight maintained based on the hallucinations questions of the Neuropsychiatric Inventory (NPI). The participant and their caregiver are asked a series of questions to determine if hallucinations are present. If present they rate the frequency of hallucinations on a scale of 1 (rarely, less than once a week) to 4, very often (once or more daily). They also rate the severity of the hallucinations, as mild (1 - present but harmless and cause little distress), moderate (2 - distressing and disruptive) or severe (3 - very disruptive, major source of behavioral disturbance, may need meds). The frequency and severity scores are multiplied (maximum score 12, with higher scores representing more distress/disability) for the total score.|Baseline and 3 months|Patients who reported hallucinations at baseline|||units on a scale||Standard Deviation|Mean
1258445|NCT00443872|Primary|Epworth Sleepiness Scale Score for Those With Daytime Sleepiness|This is a measure of daytime sleepiness. The test is a list of eight situations in which one rates their tendency to become sleepy on a scale of 0, no change of dozing to 3, high chance of dozing. The total score ranges fro 0-24, with higher values representing excessive sleepiness. A score of greater than 10 represents clinically significant sleepiness.|Baseline and 3 months|Based only on the number of patients with excessive daytime sleepiness at baseline|||units on a scale||Standard Deviation|Mean
1258446|NCT00443872|Primary|Percentage of Participants With Reduction in Adverse Events|The primary outcome measure was the reduction of daytime sleepiness, hallucinations, pedal edema, and impulse control disorders after a reduction of dopamine agonist dose with the addition of an monoamine oxidase (MAO)-B inhibitor (orally disintegrating selegiline). Percentages of participants with reduction in individual adverse events as well as reduction in any adverse events are reported.|3 Months|77 patients enrolled in the study and 60 completed. Each patient had to have at least one of the following DA related AEs, excessive daytime sleepiness, hallucinations, pedal edema or impulse control disorder (they could have more than one AE). 60 subjects were selected based on results of previous studies (discontinued patients were replaced).|||percentage of participants|||Number
1258447|NCT00443846|Primary|Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype|Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer >=1:8.|28 days after the second dose of MCC vaccine (approximately 20 weeks)|The population analyzed was randomized participants excluding those with protocol violations that may have interfered with the immunogenicity evaluation.|||Percentage of participants||95% Confidence Interval|Number
1258448|NCT00443820|Secondary|Safety and Tolerability Assessed by the Number of Participants With Adverse Events|Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.|52 weeks|Safety Population|||Number of participants|||Number
1258449|NCT00443820|Secondary|Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks|"Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.~Clinical effectiveness was a composite binary variable defined as~Yes” if:~If mycological cure (negative KOH and negative culture for dermatophytes) and~= 10% residual involvement of the target toenail~No” if otherwise"|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)|||Percentage of participants|||Number
1258450|NCT00443820|Secondary|Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks|Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)|||Percentage of participants|||Number
1258451|NCT00443820|Primary|Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks|Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)|||Percentage of participants|||Number
1258452|NCT00443781|Primary|Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)|For provocative discography (PD), a positive response at an individual disc requires all of the following findings: pain intensity (>=7/10 on 0-10 Numerical Rating Scale, NRS) as rated by subjects on injecting contrast into a disc; concordancy (pain reproduces typical back pain exactly). For Functional Anesthetic Discography (F.A.D.), a positive test at an individual disc level is defined as improvement in self-rated pain of >=2 Numerical Rating Scale (NRS) points AND >33% on 0-10 Numerical Rating Scale 10 minutes after injection of lidocaine.|Approximately 2 hours per subject|Subjects which underwent Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) consist of 1 population (N=50). Subjects which underwent either PD, F.A.D. or neither diagnostic test consist of a second population (all subjects enrolled, N=62). This is a diagnostic study. No imputation technique was used.|||discs|discs||Number
1258453|NCT00443755|Other Pre-specified|Change From Baseline in Fat-Free Mass (FFM)|FFM was measured using dual energy x-ray absorptiometry (DEXA) scans and is reported in kilograms (kg).|Baseline, 3 months|Per-protocol analysis|||kilograms||Standard Deviation|Mean
1258454|NCT00443755|Other Pre-specified|Change From Baseline in Body Fat|Body fat is reported as a percentage of body weight.|Baseline, 3 months|Per-protocol population|||percentage of body weight||Standard Deviation|Mean
1258455|NCT00443755|Other Pre-specified|Change From Baseline in Body Mass Index|Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat.|Baseline, 3 months|Per-protocol population|||kg/m^2||Standard Deviation|Mean
1258456|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker Adiponectin|Adiponectin is an anti-inflammatory cytokine and is reported in milligrams per milliliter (mg/mL).|Baseline, 3 months|Per-protocol analysis|||mg/mL||Standard Deviation|Mean
1258457|NCT00443755|Secondary|Change From Baseline in Inflammatory Biomarker Tumor Necrosis Factor-alpha (TNF-α)|TNF-α is an inflammatory cytokine and is reported in picograms/milliliter (pg/mL).|Baseline, 3 month|Per-protocol analysis|||pg/mL||Standard Deviation|Mean
1258458|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker C-Reactive Protein (CRP)|CRP is an inflammatory cytokine and is reported in milligrams per deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis|||mg/dL||Standard Deviation|Mean
1258459|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker Interleukin 6 (IL-6)|IL-6 is an inflammatory cytokine and reported in picograms per deciliter (pg/dL).|Baseline, 3 months|Per protocol analysis|||pg/mL||Standard Deviation|Mean
1258460|NCT00443755|Secondary|Change From Baseline in the Thrombotic Biomarker Plasminogen Activator Inhibitor-1 (PAI-1)|PAI-1 was measured by enzyme-linked immunosorbent assay (Diagnostica Stago Inc., Parsippany, New Jersey) and reported in nanograms per milliliter (ng/mL).|Baseline, 3 months|Per-protocol analysis|||ng/mL||Standard Deviation|Mean
1258461|NCT00443755|Secondary|Change From Baseline in the Thrombotic Biomarker Fibrinogen|Fibrinogen was measured by thrombin clotting rate assay (Beckman Coulter, Inc. Brea, California) and reported in milligrams/deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis|||mg/dL||Standard Deviation|Mean
1258462|NCT00443755|Secondary|Change From Baseline in Lipid Profile|Change in lipids were measured by the change from baseline to 3 months of triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). All were reported in milligrams/deciliter (mg/dL).|Baseline, 3 months||||mg/dL||Standard Deviation|Mean
1258463|NCT00443755|Secondary|Change From Baseline in Insulin Levels|Insulin levels in the blood were measured by immunoenzymatic assay and reported in micro International Units per milliliter (mcIU/mL).|Baseline, 3 months|Per-protocol analysis|||microIU/mL||Standard Deviation|Mean
1258464|NCT00443755|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|HbA1c is a measure of average blood sugar levels over the preceding 3 month period. HbA1c was measured by ion-exchange chromatography and reported as a percentage.|Baseline, 3 months|Per-protocol analysis|||percentage||Standard Deviation|Mean
1258465|NCT00443755|Secondary|Change From Baseline in Fasting Blood Glucose Level|Glucose (sugar) was measured in the blood and reported in milligrams per deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis|||mg/dL||Standard Deviation|Mean
1258466|NCT00443755|Primary|Change From Baseline in Insulin Sensitivity as Measured by Glucose Infusion Rate (GIR)|Insulin sensitivity was measured the morning after an overnight fast during an in-patient stay in the Clinical Research Unit & was determined by the mean GIR necessary to maintain euglycemia during a hyperinsulinemic (1.5 mcIU/kg of FFM per minute)-euglycemic (85-95 mg/dL) clamp. The clamp is an 8 hour process where a hand vein is catheterized to collect blood samples and intravenous lines are used to infuse glucose, saline, insulin, phenylalanine and amino acid solutions at at pre-specified times/rates. The mean GIR was calculated as the rate per kilograms of fat-free mass (FFM) during 4 hours of steady-state (hours 4-8 of the 8 hour clamp) reported as micromols/kilogram of FFM per minute. The FFM was measured by dual-energy x-ray absorptiometry (DEXA) scan. Insulin was infused with 5% essential amino acid solution (3mL/kg of FFM/hour) to prevent the insulin-dependent decrease of amino acids during insulin infusion.|Baseline, 3 months|Per-protocol analysis|||micromols/kg of FFM/minute||Standard Deviation|Mean
1258467|NCT00443729|Secondary|Median Percent Change From Baseline in Serum Triglyceride at Week 24|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Median
1258472|NCT00443729|Primary|Median Percent Change From Baseline in Serum Triglyceride at Week 12|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Median
1258473|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258474|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258475|NCT00443729|Primary|Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258476|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258477|NCT00443729|Other Pre-specified|Number of Patients That Discontinued Due to LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258478|NCT00443729|Other Pre-specified|Number of Patients With Serious LAEs Through 24 Weeks|Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258479|NCT00443729|Other Pre-specified|Number of Patients With Drug-related LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258480|NCT00443729|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258481|NCT00443729|Other Pre-specified|Number of Patients That Discontinued Due to CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258482|NCT00443729|Other Pre-specified|Number of Patients That Died by 24 Week Last Patient Last Visit||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258483|NCT00443729|Other Pre-specified|Number of Patients With Serious Drug-related CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258484|NCT00443729|Other Pre-specified|Number of Patients With Drug-related CAEs Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258485|NCT00443729|Other Pre-specified|Number of Patients With Serious CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258486|NCT00443729|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258487|NCT00443729|Primary|Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24||24 Weeks|Full analysis set; one patient was excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.|||Participants|||Number
1258488|NCT00443703|Secondary|Median Percent Change From Baseline in Serum Triglyceride at Week 24|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Median
1258489|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258490|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258491|NCT00443703|Secondary|Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258492|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258493|NCT00443703|Primary|Median Percent Change From Baseline in Serum Triglyceride at Week 12|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Median
1258494|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258495|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258496|NCT00443703|Primary|Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258497|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
1258498|NCT00443703|Other Pre-specified|Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks|Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258499|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258500|NCT00443703|Other Pre-specified|Number of Patients With Serious LAEs Through 24 Weeks|Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258501|NCT00443703|Other Pre-specified|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258502|NCT00443703|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258503|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258504|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258505|NCT00443703|Other Pre-specified|Number of Patients That Died by 24 Week Last Patient Last Visit||24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258506|NCT00443703|Other Pre-specified|Number of Patients With Serious Drug-related CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258507|NCT00443703|Other Pre-specified|Number of Patients With Drug-related CAEs Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258508|NCT00443703|Other Pre-specified|Number of Patients With Serious CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
1258509|NCT00443703|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
1258510|NCT00443703|Primary|Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24||Week 24|Full analysis set; two patients were excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.|||Participants|||Number
1258511|NCT00443651|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Change From Baseline at Weeks 24 and 48|The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Units on a scale||Standard Deviation|Mean
1267506|NCT00380250|Secondary|Month 2 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
1258512|NCT00443651|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Good and Moderate Responses at Weeks 24 and 48|Improvement in the post-baseline DAS 28-ESR score from baseline was used to determine the EULAR responses of moderate response and good response. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. For a post-baseline score ≤ 3.2, an improvement > 0.6 to ≤ 1.2 was a moderate response and ≥ 1.2 a good response. For a post-baseline score > 3.2 to ≤ 5.1, an improvement > 0.6 was a moderate response. For a post-baseline score > 5.1, an improvement ≥ 1.2 was a moderate response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
1258513|NCT00443651|Secondary|Percentage of Patients Achieving Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS 28-ESR) Remission and DAS 28-ESR Low Disease Activity Scores at Weeks 24 and 48|DAS 28-ESR was calculated using counts of tender and swollen joints (28 joints, 28TJC and 28SJC), a patient assessment (PA) of disease activity (DA) in previous 24 hours on a visual analog scale (no DA to maximum DA), and ESR at the current visit, using the following formula: 0.56 × 28TJC + 0.28 × 28SJC + 0.70 × ln(ESR) + 0.014 × PADA. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. DAS28-ESR Remission was defined as a DAS 28-ESR score of < 2.6. DAS28-ESR Low Disease Activity was defined as a DAS28-ESR score of ≤ 3.2.|Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab). There were 401 patients in the rituximab 1000 mg and 176 patients in the 500 mg safety populations. n = number of patients with non-missing DAS28-ESR last observation carried forward scores at Weeks 24 and 48 in the safety populations.|||Percentage of participants|||Number
1258514|NCT00443651|Secondary|Percentage of Patients With an Improvement of 20%, 50%, and 70% in American College of Rheumatology (ACR) Scores (ACR20/50/70) From Baseline at Weeks 24 and 48|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
1258515|NCT00443651|Secondary|Percentage of Patients Who Developed a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the Second Course (Optional Retreatment) of Rituximab Treatment|An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.|From start of the second course of rituximab treatment through Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
1258516|NCT00443651|Secondary|Percentage of Patients Who Developed a Serious Adverse Event (SAE) During or Within 24 Hours of Rituximab Infusions|The percentage of patients developing a SAE during or within 24 hours of a rituximab infusion is reported separately for each of the 2 infusions in the first course of treatment (Days 1 and 15) and the second course of treatment (optional retreatment during Weeks 24 to 40). See the Primary Outcome Measure for a definition of a SAE.|From start of rituximab treatment through 24 hours|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
1258517|NCT00443651|Primary|Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment|An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.|From first treatment with rituximab (Day 1) through Week 24|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
1258518|NCT00443599|Secondary|Neurodevelopmental Evaluation, Motor|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing completed at greater than 18 months post eligibility.|||Scores on a scale||Standard Deviation|Mean
1258519|NCT00443599|Secondary|Neurodevelopmental Evaluation, Language|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing was completed at greater than 18 months post eligibility.|||Scores on a scale||Standard Deviation|Mean
1289137|NCT00135707|Secondary|Aspartate Aminotransferase ≥100 U/Liter||20 weeks through discharge||||Participants|||Count of Participants
1258520|NCT00443599|Secondary|Neurodevelopmental Evaluation, Cognitive|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing completed at greater than 18 months post eligibility.|||Scores on a scale||Standard Deviation|Mean
1258521|NCT00443599|Secondary|Nutritional Status|Nutritional status assessed by percentage of total caloric intake as enteral nutrition during critical illness period.|The percentage of total caloric intake was evaluated from the day of postoperative cardiac ICU admission until the last day of the critical illness period, as defined by the presence of the arterial catheter, assessed up to 30 days.|Nutritional intake was tracked during the period of critical illness, as defined by the presence of an arterial catheter.|||Percent of total caloric intake||Inter-Quartile Range|Median
1258522|NCT00443599|Secondary|Endocrine Function|Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7.|Measured during participant’s ICU stay on Day 7.|Thyroid hormones were assayed only if the participant remained in the cardiac ICU and there was central venous or arterial access for blood sampling.|||ng/dL||Inter-Quartile Range|Median
1258523|NCT00443599|Secondary|Immune Function|Immune function is assessed by C-reactive protein (CRP) on post-operative day 7.|Post-operative day 7.|Participants analyzed include those with adequate access for blood sampling, C-reactive protein (CRP) drawn on post-operative day 7 and successful processing and preparation of samples,|||mg/dL||Inter-Quartile Range|Median
1258524|NCT00443599|Secondary|Cardiac Function|Cardiac function is assessed by duration of vasoactive support.|The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days.||||Days||Inter-Quartile Range|Median
1258525|NCT00443599|Secondary|Mortality at 30 Days.|Mortality is assessed at hospital discharge and at 30 days. If the participant is discharged from the hospital prior to 30 days, status is determined by a follow-up phone call to the family.|Measured at 30 days.|This outcome was not measured for participants lost to follow-up at 30 days post cardiac surgery.|||Participants|||Number
1258526|NCT00443599|Secondary|Mortality at Hospital Discharge.|Mortality is assessed at hospital discharge and at 30 days.|Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit).||||Participants|||Number
1258527|NCT00443599|Secondary|Duration of Endotracheal Intubation|Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation.|The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days.||||Days||Inter-Quartile Range|Median
1258528|NCT00443599|Secondary|Duration of Hospital Stay|Duration of hospital stay spans from post-operative cardiac ICU admission to hospital discharge.|The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days.||||Days||Inter-Quartile Range|Median
1258529|NCT00443599|Secondary|Duration of ICU Stay|Duration of ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge.|The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days.||||Days||Inter-Quartile Range|Median
1258530|NCT00443599|Secondary|Cardiac Index (CI)|Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area. It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry.|Day 2 (day after cardiopulmonary bypass surgery).|This outcome (using indirect calorimetry) was not available at the Michigan site, and not captured in Boston participants A) who had been extubated or were receiving only pressure support ventilation, B) without a properly placed catheter allowing for a true mixed venous sample or C) for whom equipment malfunction precluded an accurate measurement.|||liters/min/m^2||Inter-Quartile Range|Median
1258531|NCT00443599|Primary|Incidence of Nosocomial Infections in the Cardiac ICU|Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria. These definitions are extensive and cannot be accurately condensed to fit within this space. Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf.|Measured during participant's ICU stay, a median duration of 3 days.||||infections / 1000 pt days|||Number
1258532|NCT00443560|Secondary|Duration of Labor Analgesia|Time in minutes from initiation of labor analgesia until delivery of the infant|Time form initiation of labor analgesia to delivery (up to 24 hours)|Analysis was per protocal|||minutes||Inter-Quartile Range|Median
1258533|NCT00443560|Secondary|Number of Participants With Breakthrough Pain in the First Stage of Labor|Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced.|Supplemental analgesia in first stage of labor (<24 hours)|Analysis was per protocol|||participants|||Number
1258534|NCT00443560|Primary|Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor|At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued.|Second stage of labor up to 3 hours|Analysis was per protocal|||participants|||Number
1291471|NCT00113425|Secondary|Change From Baseline in Pustule Acne Lesions at Week 16||Baseline and Week 16||||pustule acne lesions||95% Confidence Interval|Mean
1258535|NCT00443534|Other Pre-specified|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.||||||
1258536|NCT00443534|Other Pre-specified|Progression-Free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.||||||
1258537|NCT00443534|Other Pre-specified|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, every 2 months until death or up to 2 years after the last dose of study treatment|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.||||||
1258538|NCT00443534|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Day 28 after last dose of study treatment|Intent to treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.|||participants|||Number
1258539|NCT00443456|Other Pre-specified|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||participants|||Number
1258540|NCT00443456|Other Pre-specified|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||participants|||Number
1258541|NCT00443456|Primary|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
1258542|NCT00443456|Primary|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
1258543|NCT00443456|Other Pre-specified|Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||mmHg||Standard Deviation|Mean
1258544|NCT00443456|Other Pre-specified|Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||mmHg||Standard Deviation|Mean
1267507|NCT00380250|Secondary|Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline|Any bowel movement not associated with rescue medication use|Change from baseline for month 3|ITT with LOCF|||SBM/week||Standard Deviation|Mean
1258545|NCT00443456|Other Pre-specified|Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||mmHg||Standard Deviation|Mean
1258546|NCT00443456|Other Pre-specified|Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||mmHg||Standard Deviation|Mean
1258547|NCT00443456|Primary|Change in Diastolic Blood Pressure From Baseline of This Long-term Study|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||mmHg||Standard Deviation|Mean
1258548|NCT00443456|Primary|Change in Diastolic Blood Pressure From Baseline of the Preceding Study|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||mmHg||Standard Deviation|Mean
1258549|NCT00443456|Primary|Change in Systolic Blood Pressure From Baseline of This Long-term Study|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||mmHg||Standard Deviation|Mean
1258550|NCT00443456|Primary|Change in Systolic Blood Pressure From Baseline of the Preceding Study|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||mmHg||Standard Deviation|Mean
1258551|NCT00443430|Secondary|Clinical Remission on Medication|6 months of clinical inactive disease|12 months or end of study|all participants receiving study medications|||participants|||Number
1258552|NCT00443430|Secondary|Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events||Over 12 months maximum study participation per subject|all participants that received study medications|||events|||Number
1258553|NCT00443430|Primary|Proportion of Participants Who Attain Inactive Disease by 6 Months||6 months after initiation of study intervention|all participants receiving study medications|||participants|||Number
1258554|NCT00443352|Primary|Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.|Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).|Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).|Number of participants for analysis was modified intention to treat - anyone who took at least one dose of duloxetine|||days||Standard Deviation|Mean
1258555|NCT00443261|Primary|Evaluate the Safety and Toxicity of Azacitidine (5-azacytidine, Vidaza®) and Cisplatin Combination|Although response is not the primary endpoint of this trial, patients with measurable disease will by assessed by standard criteria. For the purpose of this study, patients should be re-evaluated every 8 weeks by imaging study. In addition to baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response.|Weeks 1-12, 24, 36|The 1 patient enrolled in the study died after cycle 1 with rapidly progressing cancer. Therefore, no data to analyze for primary outcome measure.||||||
1258556|NCT00443209|Secondary|Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose.|2 hours post-dose (Up to 18 months)|The Full Analysis Set (FAS) population consisted of all participants who were randomized and reported at least one treated migraine attack with at least one post-treatment efficacy evaluation.|||Percentage of Migraine Attacks||Standard Deviation|Mean
1258557|NCT00443209|Primary|Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change|Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1258605|NCT00442936|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.|Up to 48 hours after first dose of study drug|The populaton consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.|||Participants|||Number
1258558|NCT00443209|Primary|Percentage of Participants With At Least One Laboratory AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1258559|NCT00443209|Primary|Percentage of Participants With At Least One Clinical AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1258560|NCT00443209|Primary|Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)|Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The All-Patients-As-Treated (APAT) population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1258561|NCT00443118|Secondary|• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks|Incidence of intracranial hemorrhage grades 3-4 for preterm newborns <32 weeks by ultrasound evaluation|1 day of life and 30 days after birth|this is an analyisis among the subgroup of subjects <32 weeks GA. this is the population at risk of this outcome. It extremely unusual intracranial hemorrhage over 32 weeks GA.|||Participants|||Count of Participants
1258562|NCT00443118|Secondary|Days on CPAP||after birth and during hospitalization up to four weeks||||days||Standard Deviation|Mean
1258563|NCT00443118|Secondary|Days on Mechanical Ventilation||after delivery and before four weeks||||days||Standard Deviation|Mean
1258564|NCT00443118|Secondary|• Need for Mechanical Ventilation or CPAP||during hospitalization||||participants|||Number
1258565|NCT00443118|Secondary|Days on Oxygen||after birth and during hospitalization up to four weeks||||days||Standard Deviation|Mean
1258566|NCT00443118|Secondary|• Use of Oxygen Treatment Beyond the Delivery Room||during hospitalization||||participants/|||Number
1258567|NCT00443118|Secondary|• Incidence of Air Leaks|included pneumothorax and Pneumomediastinum|after birth and during hospitalization up to four weeks||||participants|||Number
1258568|NCT00443118|Secondary|• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)||first week of life||||participants|||Number
1258569|NCT00443118|Secondary|Apgar Scores at 1 and 5 Minutes|categorized Apgar score 1 min <=3 and categorized Apgar score 5 min <=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes.|1-5 minutes of life||||participants|||Number
1258570|NCT00443118|Secondary|• Need for Chest Compression and/or Medications||after 2 minutes of life||||participants|||Number
1258571|NCT00443118|Secondary|• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.||after 2 minutes of life||||percentage of participants|||Number
1258572|NCT00443118|Secondary|• SpO2 Value at 2 Minutes of Life.||2 minutes of life|the pulse-oximeter was reliable at 2 minutes in 69% of the cases in both groups.|||percentage of oxygen saturation||Standard Deviation|Mean
1258573|NCT00443118|Secondary|Time the Newborn Takes to Reach a HR > 100 Bpm||2 minutes of life||||minutes||Inter-Quartile Range|Mean
1258574|NCT00443118|Primary|Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.||2 minutes of life|The analysis was performed by intention to treat|||percentage of participants|||Number
1258575|NCT00443053|Secondary|Number of Any Adjudicated Bleeding Events at Days 47 and 77|The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population|||events|||Number
1258576|NCT00443053|Secondary|Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77|Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population|||events|||Number
1258577|NCT00443053|Secondary|Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77|Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population: randomized participants who received at least one dose of study treatment, as actually received|||events|||Number
1258637|NCT00442598|Secondary|Progression-free Survival|Time from initiation of study drug to disease progression or death on study|Median measured in months||||months||Full Range|Median
1258579|NCT00443053|Secondary|Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77|VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.|Days 47 and 77|ITT Population|||participants|||Number
1258580|NCT00443053|Secondary|Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77|VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.|Baseline to Day 77|ITT Population|||participants|||Number
1258581|NCT00443053|Primary|Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47|VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.|Baseline to Day 47|Intent-to-Treat (ITT) Population: all randomized participants|||participants|||Number
1258582|NCT00443040|Secondary|Laboratory Values|Changes in laboratory values.|Daily for 38 days|||||||
1258583|NCT00443040|Secondary|Adverse Events|Adverse events grouped by body system|Daily for 38 days|||||||
1258584|NCT00443040|Secondary|Post-operative Analgesic Use||Daily for 38 days|||||||
1258585|NCT00443040|Secondary|Nasogastric Tube Re-insertion|Proportion of subjects with nasogastric tube re-insertion|Daily for 38 days|||||||
1258586|NCT00443040|Primary|Time to Return of Upper and Lower GI Function|The time to first bowel movement or the time to tolerating solid food, whichever occurs later.|Daily for 38 days|As the study was terminated early due to poor enrollment (31 of a planned 114 subjects were randomized and evaluable), no formal efficacy analyses were conducted.|||hours||Standard Deviation|Mean
1258587|NCT00443040|Secondary|Pain Score||Daily for 38 days|||||||
1258588|NCT00443040|Secondary|Vomiting Score||Daily for 38 days|||||||
1258589|NCT00443040|Secondary|Nausea Score||Daily for 38 days|||||||
1258590|NCT00443040|Secondary|Time to Writing of Hospital Discharge Order||Daily for 38 days|||||||
1258591|NCT00443040|Secondary|Time to First Bowel Movement||Daily for 38 days|||||||
1258592|NCT00443040|Secondary|Time to First Passage of Flatus||Daily for 38 days|||||||
1258593|NCT00443040|Secondary|Time to Tolerating Solid Food|Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal|4 hours of ingesting a meal|||||||
1258594|NCT00442962|Secondary|Late Change in CD4 Count From Baseline|Change in CD4+ lymphocyte counts between week 48 study visit and baseline.|At week 48|Participants with a CD4+ lymphocyte cell count result from the week 48 study visit.|||cells/mm^3||Standard Deviation|Mean
1258595|NCT00442962|Secondary|Time to First Dose Modification|Time from starting study treatment to first dose/drug modification.|Throughout study|All enrolled participants who started study treatment.|||weeks||95% Confidence Interval|Number
1258596|NCT00442962|Secondary|Percentage of Participants With Late Virologic Suppression|Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml|At Week 48|Participants with ultra-sensitive (detectable to 50 copies/mL) plasma HIV-1 RNA result available from week 48 visit.|||percentage||95% Confidence Interval|Number
1258597|NCT00442962|Secondary|Early Changes in CD4 Count From Baseline|Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.|At weeks 0(baseline), 4, 8, 16, 24|Intent to treat (study treatment status and history ignored); missing measurements ignored.|||cells/mm^3||Standard Deviation|Mean
1258598|NCT00442962|Secondary|Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)||Throughout study|All enrolled participants included.|||weeks||95% Confidence Interval|Number
1258599|NCT00442962|Secondary|Time to Initial Virological Failure|Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment.|Throughout study|All participants enrolled are included.|||weeks||95% Confidence Interval|Number
1258600|NCT00442962|Secondary|Time to Initial Virologic Response|Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.|Throughout study|All enrolled participants included.|||weeks||95% Confidence Interval|Number
1258601|NCT00442962|Secondary|Percentage of Participants With Late Virologic Response|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml|At Week 48|Participants with plasma HIV-1 RNA viral load result available from week 48 study visit.|||percentage||95% Confidence Interval|Number
1258602|NCT00442962|Secondary|Percentage of Participants With Early Virologic Suppression|Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml|At Weeks 24|ITT (ignoring current study treatment status and history); missing values ignored and closest value to week 24 used if multiple results available. 2 fewer results available compared to primary outcome b/c testing by ultrasensitive assay may have been retrospective.|||percentage of participants||95% Confidence Interval|Number
1258603|NCT00442962|Secondary|Time to First Safety Event|Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study|All enrolled participants who started study treatment (which in this case, matches the number of participants enrolled.)|||weeks||95% Confidence Interval|Number
1258604|NCT00442962|Primary|Percentage of Participants With Early Virologic Response|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml|At Week 24|Intention to treat (ignoring current study treatment status or history); closest measurement to week 24 used; missing measurements ignored. Exact binomial confidence interval calculated using method of Blyth-Still-Casella.|||percentage of participants||95% Confidence Interval|Number
1258606|NCT00442936|Primary|Number of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.|Up to 14 days after last dose of study drug|The population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.|||Participants|||Number
1258607|NCT00442936|Secondary|Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose|TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.|2 to 24 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 to 24 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 to 24 hours post-dose.|||Participants|||Number
1258608|NCT00442936|Secondary|Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose|TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 hours post-dose.|||Participants|||Number
1258609|NCT00442936|Secondary|Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose|SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.|2 to 24 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one pain score measurement at between 2 and 24 hours post-dose.|||Participants|||Number
1258610|NCT00442936|Primary|Number of Participants With Absence of Nausea at 2 Hours Post-Dose|Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline nausea assessment, and had at least one nausea assessment within 2 hours post-dose.|||Participants|||Number
1258611|NCT00442936|Primary|Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose|Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline phonophobia assessment, and had at least one phonophobia assessment within 2 hours post-dose.|||Participants|||Number
1258612|NCT00442936|Primary|Number of Participants With Absence of Photophobia at 2 Hours Post-Dose|Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline photophobia assessment, and had at least one photophobia assessment within 2 hours post-dose.|||Participants|||Number
1258613|NCT00442936|Primary|Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.|||Participants|||Number
1258614|NCT00442936|Primary|Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.|||Participants|||Number
1258615|NCT00442897|Secondary|Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment|If patients didn't achieve LDL-C <100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.|After 12 weeks of the treatment|All patient treated (APT) approach|||Participants|||Number
1258616|NCT00442897|Primary|Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment|Primary objective is to evaluate the proportion of patients achieving LDL-C target <100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)|After 6 weeks of treatment|The analysis used all patient treated (APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.|||Participants|||Number
1258617|NCT00442767|Secondary|Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.|Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone|0 to 120 minutes post-dose||||ng*L/min||Standard Error|Mean
1258638|NCT00442598|Secondary|Objective Response Rate|Objective response rate measured by RECIST v1.0|Duration of study, up to 18 weeks.||||participants|||Number
1258618|NCT00442767|Primary|Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone|Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone|0 to 240 minutes post-dose||||mmol*L/min||Standard Error|Mean
1258619|NCT00442702|Secondary|Participants With Adverse Events|Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.|Randomization to Month 10 (final visit)|Safety population|||participants|||Number
1258620|NCT00442702|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions|Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.|From randomization to Month 9|Safety population included all randomized patients who received at least one dose of trial medication and a safety follow-up, according to the treatment received.|||participants|||Number
1258621|NCT00442702|Secondary|Change in Hemoglobin Concentration From Baseline Over Time||From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.|"Intent-to-treat population, including all randomized patients. n refers to the number of patients for whom data was available at each time point."|||g/dL||Standard Deviation|Mean
1258622|NCT00442702|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period|A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.|Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).|Per Protocol population consisted of all randomized patients who had received at least one dose of trial medication and who have no major protocol violation. Data missing at the end of the evaluation period were handled using the last observation carried forward method (LOCF).|||g/dL||Standard Deviation|Mean
1258623|NCT00442689|Primary|Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period|Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)|6 months||||L/min||Standard Deviation|Mean
1258624|NCT00442689|Primary|Change in Resting Energy Expenditure (REE) Over the Study Period|Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)|6 months||||Kcal/day||Standard Deviation|Mean
1258625|NCT00442689|Primary|Change in Disposition Index|Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)|6 months||||min^-1||Standard Deviation|Mean
1258626|NCT00442689|Primary|Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period|Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)|6 months||||percentage of body mass||Standard Deviation|Mean
1258627|NCT00442689|Primary|Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI|Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)|6 months||||L||Standard Deviation|Mean
1258628|NCT00442689|Primary|Change in High-density Lipoprotein (HDL) Levels During Study Period|Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)|6 months||||mg/dL||Standard Deviation|Mean
1258629|NCT00442689|Primary|Change in Low-density Lipoprotein (LDL) Levels Over the Study Period|Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)|6 months||||mg/dL||Standard Deviation|Mean
1258630|NCT00442611|Secondary|Change in Scleroderma Health Assessment Questionnaire|"The HAQ Disability Index (HAQ-DI) includes 20 items in 8 functional domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) assessing the patient’s usual abilities in the past seven days. Each item is scored on a 0-3 scale (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=unable to do). The use of assistive devices for any domain increases the domain score by 1 point to a maximum of 3. The overall score is calculated by summing the highest item score in each of the domains and dividing the sum by 8, with an overall score of 0 indicating no disability, and a score of 3 indicating severe disability.~The time points compared were 6 months to baseline (6 months minus baseline)."|6 months|Participants with available data were analyzed.|||HAQ-DI score||Standard Deviation|Mean
1258631|NCT00442611|Secondary|Change in Pulmonary Function Tests|FVC (Forced Vital Capacity) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest possible breath. DLCO (Diffusing capacity of the lung for carbon monoxide) is the extent to which oxygen passes from the lungs to the blood.|6 months|Participants with available data were analyzed.|||% Predicted||Standard Deviation|Mean
1258632|NCT00442611|Secondary|Digital Ulcerations at Baseline and Month 6||Baseline; Month 6||||ulcers||Standard Deviation|Mean
1258633|NCT00442611|Secondary|Hand Extension at Baseline and Month 6||Baseline; Month 6||||mm||Standard Deviation|Mean
1258634|NCT00442611|Secondary|Oral Aperture at Baseline and Month 6||Baseline; Month 6||||mm||Standard Deviation|Mean
1258635|NCT00442611|Primary|Change in Modified Rodnan Skin Score|Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0–3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome).|6 months||||MRSS score||Standard Deviation|Mean
1258636|NCT00442598|Secondary|Overall Survival|Time from initiation of study drug to death.|Median measured in months, until death or censorship at analysis.||||months||Full Range|Median
1258640|NCT00442572|Secondary|Mean Change From Baseline in Triiodothyronine and Thyroxine|The Triiodothyronine (T3) and thyroxine (T4) values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||picomole/liter||Standard Deviation|Mean
1258641|NCT00442572|Secondary|Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)|The TSH was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||milli-international units/liter||Standard Deviation|Mean
1258642|NCT00442572|Secondary|Mean Change From Baseline in Blood Glucose|The blood glucose was measured for change from baseline. All blood glucose values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||millimoles/ liter||Standard Deviation|Mean
1258643|NCT00442572|Secondary|Mean Change From Baseline in Creatinine and Uric Acid|The creatinine and uric acid values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||micromole/liter||Standard Deviation|Mean
1258644|NCT00442572|Secondary|Mean Change From Baseline in Blood Urea|The blood urea was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||millimoles/liter||Standard Deviation|Mean
1258645|NCT00442572|Secondary|Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct|The laboratory parameters included bilirubin indirect and bilirubin direct. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||milligrams/deciliter||Standard Deviation|Mean
1258646|NCT00442572|Secondary|Mean Change From Baseline in Protein and Indirect Albumin|The clinical chemistry parameters included indirect protein and albumin. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and no intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Gram/deciliter||Standard Deviation|Mean
1258647|NCT00442572|Secondary|Mean Change From Baseline in Clinical Chemistry|The clinical chemistry parameters included alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP). All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Units/Litre||Standard Deviation|Mean
1258648|NCT00442572|Secondary|Mean Change From Baseline in Hematology|The hematology parameters included erythrocytes, leucocytes, basophils, eosinophils, lymphocytes, monocytes, thrombocytes. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||10^9/L||Standard Deviation|Mean
1258649|NCT00442572|Secondary|Mean Change From Baseline in Hemoglobin|The hemoglobin values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Gram/deciliter||Standard Deviation|Mean
1258650|NCT00442572|Secondary|Mean Change From Baseline in HBsAg Levels|An early decrease in HBsAg from baseline to Weeks 12 or 24 has been identified as further on-treatment predictor for sustained HBsAg clearance and virological response in HBeAg negative participants.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis.|||copies/mL||95% Confidence Interval|Mean
1258651|NCT00442572|Secondary|Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis|Fibrosis-4 (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) are non-invasive scoring systems, which are calculated on the basis of laboratory tests that indicates the level of liver fibrosis. The APRI scores are calculated based on Aspartate Aminotransferase (AST) levels and platelet counts whereas FIB-4 scores are calculated based on platelets, ALT, AST and age. For APRI, the scores are interpreted as ≤ 0.5 is 81% sensitive and 50% specific for a diagnosis of significant fibrosis in chronic hepatitis C (CHC), where as a cut-off > 1.5 is 35% sensitive and 91% specific for the diagnosis of significant fibrosis. The majority of biomarker panels will produce inconclusive results for a proportion of participants falling within the indeterminate range (between 0.5 and 1.5) for a specific fibrosis end-point. For FIB-4, the scores are interpreted as FIB-4 score of < 1.45: absence of cirrhosis, FIB-4 score of 1.45 to 3.25: inconclusive, FIB-4 score > 3.25: cirrhosis.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Units on a scale||Full Range|Median
1258652|NCT00442572|Secondary|Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity|HBV DNA level, or viral load, is an indicator of viral replication. Higher HBV DNA levels are usually associated with an increased risk of liver disease and hepatocellular carcinoma. HBV DNA level typically falls in response to effective antiviral treatment.|Up to Week 108|Safety population included all randomized participants who passed during at least one treatment period and had at least one efficacy and safety evaluation. HBV DNA levels below lower limit for significant quantity were not studied for no intervention arm participants.|||Percentage of Participants||95% Confidence Interval|Number
1258653|NCT00442572|Secondary|Percentage of Participants With HBsAg Seroconversion|The development of antibodies against HBsAg is known as HBsAg seroconversion. It signifies clearance of HBsAg and resolution of the chronic infection. НBsAg seroconversion is the final goal of anti-hepatitis B virus treatment and it is closest to the definition of “cure” but in practice it is very rare in HBeAg-negative chronic hepatitis B (CHB).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis. Only participants with HBsAg clearance were analyzed.|||Percentage of Participants|||Number
1258654|NCT00442572|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen|Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Percentage of Participants||95% Confidence Interval|Number
1258655|NCT00442572|Secondary|Percentage of Participants With Stable Virological and Biochemical Response|All participants who achieved virological response (serum HBV DNA < 20 000 copies/ml) and biochemical response (stable normalization of their alanine transaminase [ALT]) during the treatment cycle (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Percentage of Participants||95% Confidence Interval|Number
1258656|NCT00442572|Primary|Percentage of Participants With Stable Virological Response|Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) <20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Percentage of Participants||95% Confidence Interval|Number
1258657|NCT00442559|Secondary|Change From Baseline for Daily Allergic Rhinitis Symptom Score|The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.|Baseline and Week 12|The secondary efficacy parameter was a mean change from baseline to treatment for daily allergic rhinitis symptom score. Therefore 139 participants who didn't have a daily allergic rhinitis symptom score from the participant diary were not included.|||Units on scale||Standard Deviation|Mean
1258658|NCT00442559|Primary|Change From Baseline for Daytime Asthma Symptom Score|The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.|Baseline and Week 12|The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.|||Units on scale||Standard Deviation|Mean
1258659|NCT00442546|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.|Month 3, Month 6 (phone call)|MITT|||scores on a scale||Standard Deviation|Mean
1258660|NCT00442546|Secondary|Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)|"The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a no. Any positive score (1-10) of VRS was consider as yes."|Month 3, Month 6 (phone call)|MITT|||participants|||Number
1258661|NCT00442546|Secondary|Number of Subjects With Global Evaluation of Study Medication Scores|The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject’s overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent).|Discharge, Week 2, Week 4, and Week 6/ET|MITT|||participants|||Number
1258662|NCT00442546|Secondary|Overall Pain Relief Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, and Week 6/ET|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258663|NCT00442546|Secondary|Overall Satisfaction Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, and Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
1258664|NCT00442546|Secondary|Satisfaction With Medication Efficacy Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
1258665|NCT00442546|Secondary|Satisfaction With Medication Characteristics Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
1267508|NCT00380250|Secondary|Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline|Any bowel movement not associated with rescue medication use|Change from baseline for month 2|ITT with LOCF|||SBM/week||Standard Deviation|Mean
1258666|NCT00442546|Secondary|Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
1258667|NCT00442546|Secondary|Time From End of Surgery to Actual Discharge|The analysis was performed by Kaplan-Meier method with log-rank test.|time from end of surgery up to 192 hours post surgery|MITT|||hours||Standard Error|Mean
1258668|NCT00442546|Secondary|Time From End of Surgery to Meet Hospital Discharge Criteria|The analysis was performed by Kaplan-Meier method with log-rank test.|time from end of surgery up to 192 hours post surgery|MITT|||hours||Standard Error|Mean
1258669|NCT00442546|Secondary|ROM Assessment of the Passive Flexion of the Surgical Knee|The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer.|24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||degrees||Standard Error|Least Squares Mean
1258670|NCT00442546|Secondary|Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee|The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer.|24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||degrees||Standard Error|Least Squares Mean
1258671|NCT00442546|Secondary|Timed Up-and-Go (TUG)|TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 120 (Pregabalin 300 mg only), 144, 168, and 192 hours to calculate least squares mean values.|||seconds||Standard Error|Least Squares Mean
1258672|NCT00442546|Secondary|Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery|VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety.|Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery|MITT. There were not enough subjects with data at 6 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
1258673|NCT00442546|Secondary|Pain-Related Sleep Interference Post Surgery|The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge.|24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
1258674|NCT00442546|Secondary|Current Pain During the Hospital Stay Assessed by the Pain NRS|"Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question How much pain do you have right now? Scores range from 0 (no pain) to 10 (most possible pain)."|4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay|MITT. There were not enough subjects with data at 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
1258675|NCT00442546|Secondary|Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS|Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.|12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
1258676|NCT00442546|Secondary|Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)|Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.|12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
1258677|NCT00442546|Secondary|Pain Interference With Sleep as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to ‘how, during the past 24 hours, pain has interfered with your sleep’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258678|NCT00442546|Secondary|Pain Interference With Normal Work as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to ‘how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258679|NCT00442546|Secondary|Pain Interference With Walking Ability as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to ‘how, during the past 24 hours, pain has interfered with your walking ability’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258691|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET|Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 6/ET|MITT|||mg||Standard Error|Least Squares Mean
1258680|NCT00442546|Secondary|Pain Interference With Mood as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to ‘how, during the past 24 hours, pain has interfered with your mood’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258681|NCT00442546|Secondary|Pain Interference With General Activity as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to ‘how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258682|NCT00442546|Secondary|Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to ‘how, during the past 24 hours, pain has interfered with your enjoyment of life’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258683|NCT00442546|Secondary|Pain Interference With Relations With People as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to ‘how, during the past 24 hours, pain has interfered with your relations with other people’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258684|NCT00442546|Secondary|Pain Interference Index Score as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258685|NCT00442546|Secondary|Total Clinically Meaningful Event (CME) Score|CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
1258686|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score|The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258687|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score|The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258688|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score|The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT|||scores on a scale||Standard Error|Least Squares Mean
1258689|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score|The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
1258690|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET|Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 6/ET|MITT||||||
1258692|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4|Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 4|||||||
1258693|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4|Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 4|MITT|||mg||Full Range|Median
1258694|NCT00442546|Secondary|Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at Week 2 for Ibuprofen to calculate least squares mean values.||||||
1258695|NCT00442546|Secondary|Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at Week 2 and Week 4 for Ibuprofen to calculate least squares mean values.|||mg||Standard Error|Least Squares Mean
1258696|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT.|||mg||Standard Error|Least Squares Mean
1258697|NCT00442546|Secondary|Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)|Total dose for in-hospital visits was the total dose for the day.|24 hours, 48 hours, 72 hours|MITT. There were not enough subjects with data to calculate least squares mean values at 24 and 48 hours for Acetylalicyclic Acid and 72 hours for Ketorolac.|||mg||Standard Error|Least Squares Mean
1258698|NCT00442546|Secondary|Opioids Used Post Discharge|The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid.|Week 2, Week 4, Week 6/Early Termination (ET)|MITT|||mg of oral morphine equivalent||Standard Error|Least Squares Mean
1258699|NCT00442546|Secondary|Cumulative Total Amount of Opioids Used During the Entire Hospital Stay|Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia [PCA] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours|MITT. There were not enough subjects with data at 168, 192, and 216 hours to calculate least squares mean values.|||mg of oral morphine equivalent||Standard Error|Least Squares Mean
1258700|NCT00442546|Primary|Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)|"The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), subjects were asked to rate their pain by marking an X in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block."|48 hours after surgery|Modified Intent-to-Treat (MITT) Population=all ITT subjects who took 12 and 2 hours pre-surgery study medications, had no surgical or anesthetic complications during total knee replacement surgery and had at least 1 post surgery primary efficacy measurement.|||scores on a scale||Standard Error|Least Squares Mean
1258701|NCT00442507|Secondary|Incidence and Severity of Toxicities|Grade 3 and higher toxicities using CTCAE Version 3.0.|Median follow-up time for toxicities 72 days (72 days-156 days)|Details of all SAEs and AEs are listed in the Serious Adverse Events and Other Adverse Events modules.|||participants|||Number
1258702|NCT00442507|Secondary|Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)|"CR = disappearance of all target lesions~PR = at least a 30% decrease in the sum of the LD of the target lesions taking as reference the baseline sum LD."|Median follow-up for response 6 weeks (6-18 weeks)|1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.|||participants|||Number
1258703|NCT00442507|Secondary|Overall Survival Rate (OS)|OS is defined as the time from initiation of treatment to the date of death for any reason.|Median followup time from completion of treatment 325.5 days (44-401 days)||||months||95% Confidence Interval|Median
1258704|NCT00442507|Primary|Time to Progression (TTP)|"TTP is defined as the time from initiation of treatment to the date of documented progression.~The median of TTP with 95% confidence interval will be presented.~Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.~Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions."|Median follow-up for TTP 6 weeks (6-18 weeks)|1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.|||months||95% Confidence Interval|Median
1258705|NCT00442468|Secondary|"Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History"|IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.|Day 1 of 1-day study|All participant respondents to the questions|||participants|||Number
1258706|NCT00442468|Secondary|Number of Participants With the Indicated Experience With Tobacco Smoking||Day 1 of 1-day study|All participant respondents to the questions|||participants|||Number
1258707|NCT00442468|Secondary|Number of Participants Who Completed the Highest Indicated Education Level or Grade||Day 1 of 1-day study|All participant respondents to the questions|||participants|||Number
1258708|NCT00442468|Secondary|"Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status"||Day 1 of a 1-day study|All participant respondents to the questions|||participants|||Number
1258710|NCT00442468|Secondary|Post-bronchodilator Reversibility Measures|To assess the reversibility in COPD, a bronchodilator was administered before performing another round of tests for comparison. This is commonly referred to as a reversibility test for the likelihood for a participant to revert to their baseline spirometric values or a post-bronchodilator test (Post BD) and is an important part in diagnosing asthma versus COPD, particularly since reversibility is not observed in the latter case. This differentiates COPD from other diseases.|Day 1 of a 1-day study|All participants who completed pre- and post-bronchodilator spirometry|||participants|||Number
1258711|NCT00442468|Secondary|FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures|"Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight)."|Day 1 of a 1-day study|All participants who completed pre- and post-bronchodilator spirometry|||percentage||Standard Deviation|Mean
1258712|NCT00442468|Secondary|FEV1 and FVC, Post-bronchodilator Spirometry Measures|Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).|Day 1 of a 1-day visit|All participants who completed post-bronchodilator spirometry|||Liters||Standard Deviation|Mean
1258713|NCT00442468|Secondary|FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures|"Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight)."|Day 1 of a 1-day study|All participants who completed pre-bronchodilator spirometry|||percentage||Standard Deviation|Mean
1258714|NCT00442468|Secondary|FEV1 and FVC, Pre-bronchodilator Spirometry Measures|Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).|Day 1 of a 1-day study|All participants who completed pre-bronchodilator spirometry|||Liters (L)||Standard Deviation|Mean
1258715|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Experience Interference With Social Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258716|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Felt Downhearted and Depressed, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258717|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Have a Lot of Energy, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258718|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Felt Calm and Peaceful, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258719|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of to What Degree Does Pain Interfere With Normal Work, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258741|NCT00442416|Secondary|Mean Change From Baseline in Iron|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.|From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||micromole per litre||Standard Deviation|Mean
1258720|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Did Work Less Carefully Due to Emotional Problems, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258721|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Accomplished Less Due to Emotional Problems, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258722|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Were Limited in the Kind of Work/Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258723|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether They Had Accomplished Less Than They Would Like, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258724|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Climbing Stairs, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258725|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Moderate Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258726|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How They'd Rate Their General Health, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
1258727|NCT00442468|Secondary|Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire|The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).|Day 1 of 1-day study|All study participants who completed the questionnaire|||participants|||Number
1258728|NCT00442468|Secondary|Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale|The MRC scale is a 6-point scale (scores from 0 to 5; encompassing degrees of dyspnea of none, slight, moderate, moderately severe, severe, and very severe) used to assess (via a participant-completed questionnaire) the amount of routine daily physical activity that precipitates dyspnea. The levels of physical activity range from strenuous exercise, to walking (including up a slight hill, on level ground, and to 100 yards), and to dressing and undressing.|Day 1 of a 1-day study|All enrolled participants who completed the questionnaire|||participants|||Number
1258756|NCT00442169|Secondary|Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.||Days 0, 14, and 28 post-vaccination|Geometric mean titers were assessed according to the vaccine actually received, in the As treat per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1259700|NCT00435162|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)||baseline and week 6|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1258729|NCT00442468|Primary|Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%|Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. FEV1/FVC <=0.7 is used to demonstrate airway obstruction characteristic of chronic obstructive pulmonary disease (COPD).|Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)|All enrolled participants who completed pre- and post-bronchodilator spirometry|||participants|||Number
1258730|NCT00442416|Secondary|Number of Participants With Any AEs, Any Serious Adverse Events and Death|An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.|Up to 9 months|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.|||Participants|||Number
1258731|NCT00442416|Secondary|Number of Participants With Anti-RO0503821 Antibody in Human Serum|RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were “BLQ” at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.|||Participants|||Number
1258732|NCT00442416|Secondary|Number of Participants With Anti-erythropoietin Antibody in Human Serum|Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were “below the limit of quantification (BLQ)” at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.|||Participants|||Number
1258733|NCT00442416|Secondary|Mean Change From Baseline in Weight||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||kilogram||Standard Deviation|Mean
1258734|NCT00442416|Secondary|Mean Change From Baseline in Pulse Rate||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||Beats per minute||Standard Deviation|Mean
1258735|NCT00442416|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||millimeter of mercury||Standard Deviation|Mean
1258736|NCT00442416|Secondary|Mean Change From Baseline in Temperature||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||Degree Celsius||Standard Deviation|Mean
1258737|NCT00442416|Secondary|Mean Change From Baseline in Total Iron-binding Capacity|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||mg per dL||Standard Deviation|Mean
1258738|NCT00442416|Secondary|Mean Change From Baseline in Serum Transferrin|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||milligram (mg) per dL||Standard Deviation|Mean
1258739|NCT00442416|Secondary|Mean Change From Baseline in Transferrin Saturation|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||Percentage of Transferrin Saturation||Standard Deviation|Mean
1258740|NCT00442416|Secondary|Mean Change From Baseline in Ferritin|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||microgram per litre||Standard Deviation|Mean
1258757|NCT00442169|Primary|Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).|Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples|Day 28 post-vaccination|Seroconversion was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population|||Participants|||Number
1258742|NCT00442416|Secondary|Number of Participants With Marked Laboratory Abnormalities|Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as ‘n’.|||Participants|||Number
1258743|NCT00442416|Secondary|Percentage of Participants With Safety-Related Hb Measures|Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.|||Percentage of participants|||Number
1258744|NCT00442416|Primary|Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period|Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.|From Baseline (D 0) to 9 months|Per-protocol population included all randomized participants who received at least one dose of the study drug and met all study entry criteria with no major protocol violations. Participants with available data at the time of evaluation were analyzed.|||g/dL||Standard Deviation|Mean
1258745|NCT00442364|Primary|Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects||28 day followup||||participants|||Number
1258746|NCT00442351|Primary|Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.|The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.|Twelve (12) weeks|||||||
1258747|NCT00442338|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration|The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.|Baseline and 60 minutes after study drug administration|Per Protocol Set (PPS): subset of participants who comply with the protocol sufficiently to ensure that these data will likely exhibit effects of treatment, according to the underlying scientific model. Aminophylline 250 mg - 1 participant with no FEV1 data at 60 minutes was excluded from the analysis.|||Liter||95% Confidence Interval|Least Squares Mean
1258748|NCT00442286|Primary|Therapy-related Adverse Event-free Rate.|Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) therapy-related adverse event-free rates via a double-blind, randomized, parallel group, non-inferiority design for therapy-related serious adverse events occurring between 30 days post-implant and the Month 6 visit. The non-inferiority margin was 15%.|6 months post-activation||||percentage of participants||95% Confidence Interval|Number
1258749|NCT00442286|Primary|Major Hypertension-related and Serious Device-related Adverse Event-Free Rate in Both Implanted and Attempted Patients.|"Compare the event-free rate for all major hypertension-related and serious device-related adverse events occurring between 30 days post-implant and the Month 12 visit, to a pre-specified objective performance criterion of 72% based on similar implantable devices such as defibrillators and resynchronization devices.~Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort."|12 months-post activation||||percentage of participants||95% Confidence Interval|Number
1258750|NCT00442286|Primary|Serious Procedure- or System-related Adverse Event-free Rate in Both Implanted and Attempted Patients|"Compare the serious procedure- or system-related adverse event-free rate for events occurring within 30 days of implant to a pre-specified objective performance criterion of 82% set based on historical literature on implantable cardioverter defibrillators (ICD) and pacemakers.~Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort."|30 days post implant||||percentage of participants||95% Confidence Interval|Number
1258751|NCT00442286|Primary|Percent of Group A (Rheos® Device On) Patients Who Maintain a 10 mm Hg Drop in Systolic Blood Pressure at 12 Months Post-activation, and Whose Response at 12 Months is at Least 50% of the Response Observed at 6 Months Post-activation.|Compare the sustained response in SBP Month 12 in Group A ( Rheos® Device On ) responders at Month 6 to an objective performance criterion of 65%. A sustained response to therapy required the reduction from Month 0 to Month 12 to be at least 10 mmHg and to remain at least 50% of that seen at Month 6.|12 months post-activation||||percentage of participants||97.5% Confidence Interval|Number
1258752|NCT00442286|Primary|Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure|Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) via a double-blind, randomized, parallel group, super-superiority design for proportion of subjects that achieve at least a 10 mm Hg drop in systolic blood pressure at Month 6 compared to Month 0, with a superiority margin of 20%.|6 months post-activation||||percentage of participants||95% Confidence Interval|Number
1258753|NCT00442169|Primary|Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.||Days 0 to 28 post-vaccination|Safety analysis was on all enrolled and vaccinated participants according to the vaccine actually received, safety population.|||Participants|||Number
1258754|NCT00442169|Primary|Number of Viremic Participants Post-vaccination|Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL|Day 21 post-vaccination|Viremia was assessed in all participants in the safety population according to the vaccine actually received.|||Participants|||Number
1258755|NCT00442169|Other Pre-specified|Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population||Days 14 and 28 post-vaccination|Immunoglobulin M (IgM) response was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population|||Participants|||Number
1258758|NCT00442117|Secondary|Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.|The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information. Two participants in the MF-DPI group and three participants in the BUD-DPI group were excluded from the analysis.|||Percent Change of AM PEFR||Standard Deviation|Mean
1258759|NCT00442117|Secondary|Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.|The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.|||Percent Change of FEF||Standard Deviation|Mean
1258760|NCT00442117|Secondary|Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.|The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.|||Percent Change of FVC||Standard Deviation|Mean
1258761|NCT00442117|Primary|Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.|FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.|||Percent Change of FEV1||Standard Deviation|Mean
1258762|NCT00442013|Secondary|Airways Reactivity (Assessed by Methacholine PC20)|Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds|Measured at Weeks 0 and 24||||mg/mL||95% Confidence Interval|Mean
1258763|NCT00442013|Secondary|Asthma Symptom Utility Index (ASUI)|ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24||||score||95% Confidence Interval|Mean
1258764|NCT00442013|Secondary|Rate of Episodes of Poor Asthma Control (EPAC)|"Episodes of poor asthma control are defined as any one of the following:~2 consecutive days with peak flow at less than 70% of baseline~prescription of oral corticosteroids for asthma~seeking urgent medical care for asthma symptoms~EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks"|Measured daily for 24 weeks by diary|The number of episodes of poor asthma control that occurred in each group over the 24-week follow-up period. Some participants experienced more than one EPAC over the course of follow-up|||number of episodes of poor asthma contrl|||Number
1258765|NCT00442013|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24||||Liters||95% Confidence Interval|Mean
1258766|NCT00442013|Secondary|Asthma-specific Quality of Life|Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24||||score||95% Confidence Interval|Mean
1258767|NCT00442013|Primary|Change in Juniper Asthma Control Score (ACS)|Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 24||||score||95% Confidence Interval|Mean
1258768|NCT00441974|Secondary|Number of Participants With ADV-associated Resistance at Week 48|Week 48 serum samples from participants, who reached a HBV DNA breakthrough or have HBV DNA≥5 log copies/mL at Weeks 24 and 48 were assessed for the development of ADV (Adefovir dipivoxil) mutation (N236T and A181V) in the HBV polymerase. Virologic breakthrough was defined as an increase in the level of HBV DNA 1 log10 copy/mL from Week 24 to Week 48. ADV-associated resistance was defined as participants with both virologic breakthrough and ADV mutation.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
1258769|NCT00441974|Secondary|Number of HBeAg Positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Week 48|HBeAg loss and HBeAg seroconversion (HBeAg loss and HBeAb detected) were assessed in participants who were HBeAg positive at Weeks 0 and 48. Confirmed HBeAg loss was defined as undetectable HBeAg.|Week 48|Intent-to-Treat (ITT) Population: all HBeAg positive participants who actually received the study medication at least once|||participants|||Number
1258770|NCT00441974|Secondary|Number of Participants Achieving ALT (Alanine Aminotransferase) Normalization at Week 48|Elevated serum ALT levels are defined as serum ALT levels greater than the upper limit of the normal range (ULN), as determined using local laboratory ranges. ALT normalization was defined as ALT measurements at or below the ULN after a baseline value above the ULN.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
1258771|NCT00441974|Secondary|Change From Screening in Median Serum HBV DNA at Weeks 24 and 48|The HBV DNA level was tested in blood serum by real-time Polymerase Chain Reaction with the LLD (lower limit of detection) as 300 copies/milliliter (cp/mL) at screening, week 24, and week 48 in a central laboratory. The change in HBV DNA from screening to week 24 and week 48 was conducted.|Weeks 24 and 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||log10 copies/milliliter||Full Range|Median
1289138|NCT00135707|Secondary|Medically Indicated Delivery Because of Hypertension||20 weeks through discharge following delivery||||Participants|||Count of Participants
1258772|NCT00441974|Secondary|Ranked Assessment of Liver Histology in HBeAg Positive Participants From Baseline to Week 48|A ranked assessment with the Knodell/HAI scoring system that represents the sum of scores for periportal bridging necrosis (0–10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0–4: none=0, marked=4); portal inflammation (0–4: none=0, marked=4) and fibrosis (0–4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two pathologists in the HBeAg positive participants who underwent liver biopsy at baseline and Week 48/withdrawal.|Baseline to Week 48|HBeAg positive chronic hepatitis B participants who underwent liver biopsy at Week 48|||points on a scale||Standard Deviation|Mean
1258773|NCT00441974|Secondary|Number of HBeAg Positive Participants Achieving Histological Improvement at Week 48|Histological improvement (defined as a ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was accessed by two pathologists in HBeAg-positive participants undergoing liver biopsy at baseline and week 48/withdrawal. Knodell/Histological Activity Index (HAI) score = combined scores for necrosis, inflammation, and fibrosis and is the sum of scores for periportal bridging necrosis (0–10: none=0, multilobular necrosis=10), intralobular degeneration and focal necrosis and portal inflammation (0–4: none=0, marked=4), and fibrosis (0–4: none=0, cirrhosis=4).|Week 48|HBeAg positive chronic hepatitis B participants who underwent liver biopsy at Week 48|||participants|||Number
1258774|NCT00441974|Primary|Number of Participants Achieving HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) <1000 Copies/Milliliter at Week 48|HBV (Hepatitis B Virus) DNA level was tested by real-time Polymerase Chain Reaction at Week 48.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
1258775|NCT00441792|Primary|Length of Stay|The primary outcome of the study was hospital length of stay.|time in days of hospitalization|All patients entering into the study were analyzed on an intent to treat basis.|||days||Inter-Quartile Range|Median
1258776|NCT00441792|Secondary|Mortality|In-hospital mortality.|Duration of hospitalization.|All patients entering into the study were analyzed on an intent to treat basis.|||percentage of patients dying||95% Confidence Interval|Number
1258777|NCT00441766|Secondary|Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)|Change from baseline in the frequency of bowel movements per day using the BSS. The BSS categorizes stool based on the patient's description of its consistency. Patients are classified into 3 IBS subtypes according to their predominant stool patterns (C=constipation; D=diarrhea; M=mixed). A positive change from baseline in the IBS-C indicates improvement and a negative change from baseline in the IBS-D and IBS-M indicates improvement.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.|||Bowel Movements (Stools) Per Day||Standard Deviation|Mean
1258778|NCT00441766|Secondary|Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4|"Percentage of patients who experienced AR-IBS at week 4. The AR-IBS is a self-evaluation by the patient of their perception of adequate relief of IBS pain over the last 7 days following treatment as compared to IBS pain before receiving treatment. Patients respond with either a Yes or No, where Yes indicated adequate relief of pain and No indicated no relief from pain."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.|||Percentage of Patients|||Number
1258779|NCT00441766|Secondary|Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4|"Percentage of patients who rated their condition as improved on the SGIC at week 4. The SGIC score was assessed using a 7-point scale (score of 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). Patients self-evaluated their overall change in symptoms (relief from symptoms of abdominal discomfort, pain, and altered bowel habits). An improved condition was defined as a score of 1, 2, or 3."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.|||Percentage of Patients|||Number
1258780|NCT00441766|Primary|Change From Baseline in Mean Highest-Average-Pain Score at Week 4|Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.|||Scores on a Scale||Standard Deviation|Mean
1258781|NCT00441727|Secondary|Number of Participants With Gastric and/or Duodenal Erosions.||The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|Patients randomized who had endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|||participants|||Number
1258782|NCT00441727|Secondary|Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.|RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.|RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.|Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.|||participants|||Number
1258806|NCT00441558|Primary|The Frequency of Adverse Events (Side Effects).|This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder|52 weeks||||participants with any adverse event|||Number
1283003|NCT00234286|Secondary|Individuals With an Order for Benzodiazepine Medication|Order for benzodiazepine medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1258783|NCT00441727|Secondary|Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.|RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.|RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.|Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.|||participants|||Number
1258784|NCT00441727|Secondary|Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.|The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks||||percentage of participants|||Number
1258785|NCT00441727|Secondary|Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.|The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks||||percentage of participants|||Number
1258786|NCT00441727|Primary|Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).|The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks||||percentage of participants|||Number
1258787|NCT00441701|Secondary|Part 2: Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Individual/Total Domains|SGRQ consists of 76 items aggregated into 3 domain scores: Symptoms (frequency/severity), Activity (cause or limited by breathlessness), Impact (social functioning, psychological disturbances from airway disease), and total score. Participants were to assess their symptoms, activity and impact at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for SGRQ. Part 2 of this study was not conducted under this protocol.||||||
1258788|NCT00441701|Secondary|Part 2: Change From Baseline in Individual Symptom Scores|Participants were to be assessed for individual symptom scores at Baseline and Week 12 using the following scales: Sputum Production (0=none, unaware of any sputum production to 4=severe, an almost constant problem), Cough (0=none, unaware of coughing to 4=severe, never free of cough or need to cough), and Dyspnea (0=none, unaware of any difficulty to 4=severe, almost constant: present even when resting).|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for individual symptom scores. Part 2 of this study was not conducted under this protocol.||||||
1258789|NCT00441701|Secondary|Part 2: Change From Baseline in Induced Sputum Percent Neutrophil Count|Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Part 2 of this study was not conducted under this protocol.||||||
1258790|NCT00441701|Secondary|Part 2: Change From Baseline in Induced Sputum Absolute Neutrophil Count|Participants were to be assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count. Part 2 of this study was not conducted under this protocol.||||||
1258791|NCT00441701|Secondary|Part 2: Change From Baseline in Peak Expiratory Flow (PEF)|PEF, as measured in liters/minute via peak flow meter, is the maximum speed of expiration. Participants were to measure their PEF in triplicate every morning before taking study drug and again every evening.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for PEF. Part 2 of this study was not conducted under this protocol.||||||
1258792|NCT00441701|Secondary|Part 2: Number of Participants Who Experience a COPD Exacerbation|COPD exacerbation is defined as any change in symptoms or functional status that leads to administration of systemic corticosteroids, antibiotics, an emergency room visit or a hospitalization. The number of participants who experienced a COPD exacerbation was to be summarized.|Up to Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a at least one post-Baseline assessment for presence of COPD exacerbation. Part 2 of this study was not conducted under this protocol.||||||
1258793|NCT00441701|Secondary|Part 2: Change From Baseline in Functional Residual Capacity (FRC)|FRC, as measured in liters via body plethysmography, is the volume of air present in the lungs, specifically the parenchyma tissues, at the end of passive expiration. Participants were to be assessed for FRC at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FRC. Part 2 of this study was not conducted under this protocol.||||||
1258794|NCT00441701|Secondary|Part 2: Change From Baseline in FVC|FVC, as measured in liters via spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FVC. Part 2 of this study was not conducted under this protocol.||||||
1258807|NCT00441545|Secondary|Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks|Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)|4 weeks||||Percentage of Participants|||Number
1258808|NCT00441545|Secondary|Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks||Baseline and 4 weeks|ITT|||pg/mL||Standard Error|Mean
1258795|NCT00441701|Secondary|Part 2: Change From Baseline in Forced Expiratory Flow During Middle Half of Forced Vital Capacity (FVC) (FEF25%-75%)|Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute via spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. Participants were to be assessed for FEF25%-75% at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for FEF25%-75%. Part 2 of this study was not conducted under this protocol.||||||
1258796|NCT00441701|Secondary|Part 2: Change From Baseline in Post-Bronchodilator FEV1|FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after dosing with bronchodilator (albuterol sulfate or equivalent) (reversibility test) at Baseline and Week 12. Post-bronchodilator data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for post-bronchodilator FEV1. Part 2 of this study was not conducted under this protocol.||||||
1258797|NCT00441701|Secondary|Part 1: Change From Baseline in Sputum Percent Neutrophil Count (Induced Sputum)|Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 1 participants who were randomized, received at least 1 dose of study drug, and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Since sufficient data for analysis were collected for absolute sputum neutrophil count, percent sputum neutrophil count was not assessed.||||||
1258798|NCT00441701|Secondary|Part 1: Change From Baseline in Sputum Absolute Neutrophil Count (Induced Sputum)|Participants were assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12. The reported SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and Week 12|The population consisted of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count.|||10^9 cells/L||Standard Deviation|Mean
1258799|NCT00441701|Secondary|Part 1: Change From Baseline in Percent PBN Count|Participants were to be assessed for percent PBN counts at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and a Week 12 assessment for percent PBN count. Since sufficient data for analysis were collected for absolute PBN count, percent PBN count was not assessed.||||||
1258800|NCT00441701|Primary|Part 2: Change From Baseline in Daily Morning/Nighttime Sputum Production, Cough, and Dyspnea (SCDS) Score|Participants were to assess their morning (AM) and nighttime (PM) COPD symptoms (sputum production, cough, and dyspnea) on a daily basis in their e-Diaries. Baseline SCDS was defined as the average of AM and PM values over the week prior to and including Day 1 (AM) prior to the first dose of study drug. SCDS data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for AM/PM SCDS scores. Part 2 of this study was not conducted under this protocol.||||||
1258801|NCT00441701|Primary|Part 2: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for pre-bronchodilator FEV1 immediately before dosing with bronchodilator (albuterol sulfate or equivalent) at Baseline and at Week 12. Pre-bronchodilator FEV1 data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for FEV1. Part 2 of this study was not conducted under this protocol.||||||
1258802|NCT00441701|Primary|Part 1: Change From Baseline in Absolute Peripheral Blood Neutrophil (PBN) Count|Participants were assessed for absolute PBN counts at Baseline and Week 12. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and Week 12|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug and had a Baseline and a Week 12 assessment for absolute PBN count.|||10^9 cells/L||Standard Deviation|Mean
1258803|NCT00441701|Primary|Part 1: Number of Participants Who Discontinue Study Drug Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.|Up to 12 weeks|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug.|||Participants|||Number
1258804|NCT00441701|Primary|Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who experienced an AE, regardless of causality or severity, was summarized.|Up to 12 weeks|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug.|||Participants|||Number
1258805|NCT00441584|Primary|Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment|Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is < 30 IU/mL in this study.|Up to 48 weeks of treatment plus 24 weeks follow up|The All Treated population included all subjects who took at least one dose of study medication.|||Participants|||Number
1258809|NCT00441545|Secondary|Change From Baseline in Serum Calcium Levels at 4 Weeks||4 weeks|ITT|||mg/dL||Standard Error|Least Squares Mean
1258810|NCT00441545|Primary|Change From Baseline in Serum Phosphorus Levels at 4 Weeks||4 weeks|ITT population defined as subjects who were randomized, received at least one dose of investigational product, and had at least one post-dose assessment of the primary efficacy variable.|||mg/dL||Standard Error|Least Squares Mean
1258811|NCT00441480|Secondary|Apolipoprotein A|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258812|NCT00441480|Secondary|Apolipoprotein A|Blood test on day 0|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258813|NCT00441480|Secondary|Apolipoprotein B100|Blood test results follwing 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258814|NCT00441480|Secondary|Apolipoprotein B100|Blood test results on day 0|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258815|NCT00441480|Secondary|CRP|Blood test results following 12 weeks of intervention of High sensetivity C reactive protein|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/l||Standard Deviation|Mean
1258816|NCT00441480|Secondary|CRP|Blood test results on day 0 of High sensitivity C Reactive Protein|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/l||Standard Deviation|Mean
1258817|NCT00441480|Secondary|HDL-cholestrol|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258818|NCT00441480|Primary|LDL-C|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||md/dl||Standard Deviation|Mean
1258819|NCT00441480|Secondary|HDL Cholesterol|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258820|NCT00441480|Secondary|Total Cholesterol|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258821|NCT00441480|Secondary|Total Cholesterol|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258822|NCT00441480|Secondary|Triglycerides|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258823|NCT00441480|Secondary|Triglycerides|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258824|NCT00441480|Primary|LDL Cholesterol|Average of blood test results at -10 and 0 days (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
1258825|NCT00441467|Secondary|Overall Survival||All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.||||months||95% Confidence Interval|Median
1258826|NCT00441467|Secondary|Progression-free Survival||All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.||||months||95% Confidence Interval|Median
1259536|NCT00436553|Secondary|Change From Baseline in Total Area of Leakage of the Study Eye at Month 12|Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Baseline and Month 12|Full analysis set (FAS), observed data.|||mm^2||Standard Deviation|Mean
1258827|NCT00441467|Primary|Objective Response Rate|The event rate was the response rate (complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). The associated 95% exact binomial confidence intervals were calculated.|Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.|Patients receiving glufosfamide with a post treatment imaging assessment|||participants|||Number
1258828|NCT00441441|Post-Hoc|Geometric Mean Ratio for Baseline: Week 12 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value,nanomoles per 24 hours (nmol/24 hrs) .|Baseline and Week 12|Cortisol Population|||ratio|||Number
1258829|NCT00441441|Post-Hoc|Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population|||Nanomoles per 24 hr (nmoles/24 hr)||Full Range|Geometric Mean
1258830|NCT00441441|Post-Hoc|Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion|A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nmol/24 hrs. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs) .|Baseline and Week 12|Cortisol Population|||ratio|||Number
1258831|NCT00441441|Post-Hoc|Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12|A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nanomoles/24 hours. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population|||Nanamoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
1258832|NCT00441441|Secondary|Percent of Albuterol-free Days|Percentage of days when Albuterol use was unnecessary based on daily record and symptom free days.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.|||Percentage of days||Standard Error|Mean
1258833|NCT00441441|Secondary|Albuterol Use|Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.|||Number of puffs per 24 hours||Standard Error|Mean
1258834|NCT00441441|Secondary|Percentage of Symptom Free Days|Percentage of number of days without asthma symptoms based on Asthma Symptom Scores. Each morning prior to dosing or PEF, asthma symptoms were self-scored based on the past 24 hours: 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=frequent symptoms that did not affect activities of daily living (ADL), 4=frequent .|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.|||Percentage of days||Standard Error|Mean
1258835|NCT00441441|Secondary|Asthma Symptom Scores|Each morning prior dosing or PEF, self-scored based on past 24 hours: 0=No symptoms, 1=Symptoms for one short period, 2=Symptoms for two or more short periods, 3=Frequent Symptoms which did not affect activities of daily living (ADL), 4=Frequent.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.|||Score in scale||Standard Error|Mean
1258836|NCT00441441|Secondary|AM Peak Expiratory Flow|The peak expiratory flow (PEF) rate measures how fast a person can exhale air. It is used to compare to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 inches is 147 Liters/minute (L/min), whose height is 66 inches is 454 L/min. Triplicate measurements taken for the best effort recorded.|Baseline and 12-Week Treatment Period|Participants from the ITT Population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 173 and 174 at Weeks 1-12; and 171 and 173 for the last 7 days on treatment.|||Liters/minute (L/min)||Standard Error|Mean
1258837|NCT00441441|Secondary|Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years|"FEV1 (Forced Expiratory Volume in 1 second) is the volume of air that can be forced out in one second, after taking a deep breath. FEV1 is measured using a spirometer and obtaining best effort from 3 to 8 measurements. Week 12 is the measure taken at Week 12."|Baseline and week 12|Subset of ITT Population: Participants who were 6-11 years of age (population not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 137 and 136 at baseline; 126 and 124 at Week 12, and 6 and 7 at premature discontinuation.|||Liters per second (L/sec)||Standard Error|Mean
1259013|NCT00440505|Primary|Pain Score|Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.|1 day|This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.|||Units on a scale||Standard Deviation|Mean
1259014|NCT00440466|Other Pre-specified|Number of Participants Who Died||36 weeks of treatment||||Participants|||Number
1258838|NCT00441441|Primary|Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).|Baseline and Week 12|Cortisol Population|||ratio|||Number
1258839|NCT00441441|Primary|Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population|||Nanomoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
1258840|NCT00441441|Primary|Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use|"AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Abnormal high cortisol excretion and Abnormal low cortisol excretion are defined as above the upper limit of normal and below the lower limit of normal, respectively. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory."|Baseline and Week 12|Cortisol Population|||participants|||Number
1258841|NCT00441441|Primary|Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion|Normal range for Cortisol levels vary by age and gender. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).|Baseline and Week 12|Cortisol Population|||ratio|||Number
1258842|NCT00441441|Primary|Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12|Normal range for Cortisol levels vary by age and gender. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population|||Nanomoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
1258843|NCT00441441|Primary|Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion|"Abnormal high cortisol excretion and Abnormal low cortisol excretion are defined as above the upper limit of normal and below the lower limit of normal, respectively. The normal range for cortisol levels vary by age and gender. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory."|Baseline and week 12|Cortisol Population - all participants not excluded due to the following reasons: missing data, use of protocol-specified corticosteroids (prior to screening), collection time outside of 24 ± 2 hours, use of inhaled cortical steroid (ICS) during treatment, and who stopped study medication >1 day prior to start of post-baseline urine collection.|||participants|||Number
1258844|NCT00441441|Primary|Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols|The Primary Investigator determined the severity of the exacerbation based on the participant’s clinical presentation and the investigator’s understanding of the disease, the participant, and his or her clinical experiences. The severity of the exacerbation was not defined in the protocol. Mild: Usually treated at home. Prompt relief with inhaled short-acting beta2 agonist. Possible short course of oral systemic corticosteroids. Moderate: Usually requires office or emergency department visit. Relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for 1-2 days after treatment begins. Severe: Usually requires emergency department visit and likely hospitalization. Partial relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for more than 3 days after treatment begins. Adjunctive therapies are helpful.|Treatment period (weeks 1-12)|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||participants|||Number
1258845|NCT00441441|Primary|Cardiovascular Adverse Events Reported During the Post-Treatment Period|Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Post-treatment period, defined as 1 day after last dose of study drug. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event.|5 Days after Week 12|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||participants|||Number
1258846|NCT00441441|Primary|Cardiovascular Adverse Events Reported During Treatment Period|Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Treatment Period. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event. Please see the category titles for a list of candidate cardiovascular adverse events.|12-Week Treatment Period|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||participants|||Number
1258847|NCT00441441|Primary|ECG Measures - QT Interval|Fridericia’s formula QTc interval=QT interval/cubed root of the R-R interval. The Bazett’s formula QTc=QT/squared root of the R-R interval.|Baseline and Week 12|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||milliseconds||Full Range|Mean
1258848|NCT00441441|Primary|ECG Measures – Heart Rate|The range of heart rates for this study was between 49-144 beats per minute|Baseline and Week 12|ITT Population - All subjects who were randomized and received at least one dose of double-blind study treatment.|||beats per minute||Full Range|Mean
1259015|NCT00440466|Other Pre-specified|Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||g/dL/2 weeks||Standard Deviation|Mean
1283004|NCT00234286|Secondary|Individuals Administered Antipsychotic Medication|Administration of antipsychotic medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1258849|NCT00441441|Primary|Clinically Significant Unfavorable ECGs at Week 12|Post-randomization ECGs categorized by the primary investigator as no change, significant change (favorable), significant change (unfavorable) from the ECG performed at Visit 1 (Baseline) are presented. Significant change (favorable) includes any ECG that improved from baseline, whereas significant change (unfavorable) includes any ECG that worsened from baseline. Clinical significance is determined by the primary investigator.|Baseline, Week 12|ITT Population. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The numbers of participants at Week 12 were 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.|||participants|||Number
1258850|NCT00441441|Primary|Investigator Evaluations of Electrocardiogram (ECG) Results|ECGs were transmitted to an independent cardiologist who was responsible for providing interpretation of the ECG as either normal or abnormal (based on personal assessment). The investigator was then responsible for determining the clinical significance of the abnormal ECG in the context of the participants’ history and clinical presentation. An abnormal, clinically significant ECG included, but was not limited to: prolonged QT interval, ischemic changes, ventricular hypertrophy, intraventricular conduction abnormalities, and clinically significant arrhythmias. PD, premature discontinuation.|Baseline and Week 12|ITT Population. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The number of participants at Week 12 was 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.|||participants|||Number
1258851|NCT00441441|Primary|Possible Drug-Related Adverse Events|Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG.|Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)|Intent-to-Treat (IITT) Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||participants|||Number
1258852|NCT00441363|Secondary|Number of Serious Adverse Events Experienced by the Subjects||up to 24 weeks|Report of Serious adverse events that occurred in the trial.|||serious adverse events|||Number
1258853|NCT00441363|Secondary|Fasting Plasma Glucose and Lipids||up to 24 weeks|||||||
1258854|NCT00441363|Primary|Change in Baseline to End of Study in HbA1c|Too few subjects were enrolled to assess outcome to pre-specified statistical power.|up to 24 weeks||||% HbA1c||Standard Deviation|Mean
1258855|NCT00441337|Secondary|Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population|Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBPs on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.|||mmHg||Standard Deviation|Mean
1258856|NCT00441337|Secondary|Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population|Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.|||mmHg||Standard Deviation|Mean
1258857|NCT00441337|Secondary|Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population|Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.|||mmHg||Standard Deviation|Mean
1258858|NCT00441337|Secondary|Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population|Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.|||mmHg||Standard Deviation|Mean
1258859|NCT00441337|Secondary|Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population|12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec).|Baseline, Day 2, Day 85, Day 113|All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed.|||msec||Standard Deviation|Mean
1289139|NCT00135707|Secondary|Pregnancy Associated Hypertension||20 weeks through discharge following delivery||||Participants|||Count of Participants
1258860|NCT00441337|Secondary|Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population|PSA relative velocity (PSA RV) was defined as = (d[PSA]/dt)/ [PSA], where [PSA] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured [PSA] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement.|Day 29, Day 57, Day 85|The PSA evaluable population includes all participants in the study who received complete dose(s) of nivolumab and has a baseline PSA assessment and at least 1 post-baseline PSA assessment.|||percentage of total PSA level||Full Range|Median
1258861|NCT00441337|Secondary|Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population|Time to PSA progression: first dose to first PSA progression. Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment. PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first. Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment. CI computed using Brookmeyer and Crowley method.|Day 1 to 2 Years|The PSA evaluable population include all participants in the study who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least 1 post-baseline PSA assessment.|||days||95% Confidence Interval|Median
1258862|NCT00441337|Secondary|Time to Tumor Progression and Tumor Progression Free Survival|Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death.|Day 1 to 2 Years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||days||95% Confidence Interval|Median
1258863|NCT00441337|Secondary|Median Time to Tumor Response and Duration of Tumor Response|Time to tumor response: from the date of first dose to the first date of tumor response (CR or PR confirmed at least 4 weeks later); for nonresponders, it was censored at the date of the maximum tumor assessment time in the dose cohort by the end of study. Duration of tumor response was calculated from the first date of response of CR or PR to the date of the first PD or the date of death if a participant died due to disease progression (whichever occurred first). Duration of response was censored at the last tumor assessment date by the end of study if a responder did not have PD or death. Nonresponders had the duration of response as an event of 0 days.|Day 1 to 2 Years|All participants who received at least 1 dose or any partial dose of nivolumab and were tumor responders were analyze.|||days||95% Confidence Interval|Median
1258864|NCT00441337|Secondary|Percentage of Participants With Disease Control and Major Durable Disease Control|Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method.|Day 1 to 2 Years|Safety Population was analyzed: All participants who received at least 1 dose or any partial dose of nivolumab.|||percentage of participants||95% Confidence Interval|Number
1258865|NCT00441337|Secondary|Number of Participants With Best Overall Response (BOR) by Category in Safety Population|Measurable and non-measurable disease/target lesions were evaluated according to National Cancer Institute standardized RECIST.Complete Response (CR)=disappearance of all target and non-target lesions and no new lesions; Partial Response=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; Stable disease (SD)=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since treatment; PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. BOR was recorded between the first tumor assessment and last tumor assessment. CR and PR had to be confirmed by repeat assessment no less than 4 weeks after the criteria were first met. SD assessment must have met the criteria at least once at or after Week 12.|Day 1 to Day 85|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||participants|||Number
1258873|NCT00441337|Primary|Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1291472|NCT00113425|Secondary|Change From Baseline in Papule Acne Lesions at Week 16||Baseline and Week 16||||papule acne lesions||95% Confidence Interval|Mean
1258866|NCT00441337|Primary|Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC)|The PSA response rate was defined as the number of participants who had at least a 50% decrease of the PSA value from the PSA reference value divided by the total number of participants evaluated (percent of participants). PSA reference value was the PSA concentration measured immediately prior to dosing on Day 1. PSA response was assessed using the Recommendations from the National Cancer Institute Prostate-Specific Antigen Working Group. A PSA response had to be confirmed at least 4 weeks after first response. 95% exact CIs were computed using the Clopper and Pearson method.|Day 1 to Day 85|The PSA evaluable population was analyzed and included all HRPC participants who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least one post baseline PSA assessment. A PSA evaluable participant could not have any major inclusion/exclusion violation, dosing violation, or protocol conduct violation.|||percentage of participants||95% Confidence Interval|Number
1258867|NCT00441337|Primary|Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population|The Best Overall Response Rate (BORR) was defined as the number of participants who had a confirmed complete response (CR) or partial response (PR) during the study divided by the total number of participants evaluated. Response was based on tumor assessment for both target and non-target lesions using: Clinical examination; Chest X-ray; Computed Tomography and Magnetic Resonance Imaging; Bone scan; Ultrasound. Per National Cancer Institute Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, best overall response (BOR) for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. Confidence intervals (CIs) were computed using the Clopper and Pearson method.|Day 1 up to 2 Years.|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. Tumor Evaluable Population: all participants who received complete dose(s) of nivolumab and had completed a major tumor assessment (a baseline and at least 1 post-baseline tumor assessment for either target and/or non-target assessments.|||percentage of participants||95% Confidence Interval|Number
1258868|NCT00441337|Primary|Mean Volume of Distribution (Vz) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Vz was measured in milliliters per kilogram of body weight (mL/kg).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||mL/kg||Standard Deviation|Mean
1258869|NCT00441337|Primary|Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
1258870|NCT00441337|Primary|Mean Elimination Half-life (T-HALF) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days.|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||days||Standard Deviation|Mean
1258871|NCT00441337|Primary|Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose|AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms*hours per milliliter (µg*h/mL).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1258872|NCT00441337|Primary|Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||h||Full Range|Median
1258986|NCT00440830|Primary|Postoperative Pain Score One Hour After Surgery|Postoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.|1 hour after surgery||||Numeric Rating Scale (NRS)||Standard Deviation|Mean
1283005|NCT00234286|Secondary|Individuals With an Order for Antipsychotic Medication|Order for antipsychotic medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1258874|NCT00441337|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.|Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||participants|||Number
1258875|NCT00441285|Secondary|Phase III Trial - Seizure Frequency|Seizure frequency by treatment group|Day 1 - 540|Final population numbers for this analysis not yet defined||||||
1258876|NCT00441285|Primary|Phase III Trial - Proportion of Patients Without Remaining Live Cysts|Proportion of patients whose 6 month MR does not show viable parasites anymore|Day 180|Some patients did not reach the analysis time point.|||participants|||Number
1258877|NCT00441285|Secondary|Phase III Trial - Proportion of Cysts Which Resolved|Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI|Day 180|Final population numbers for this analysis not yet defined||||||
1258878|NCT00441285|Secondary|PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy|- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.|90 days post tx||||Events|||Number
1258879|NCT00441285|Primary|PK Substudy - Maximum Concentration of Albendazole|Highest serum level of Albendazole measured from all level assessments in the curve.|Treatment day 1 and Treatment days 10-11||||ng/mL||Standard Deviation|Mean
1258880|NCT00441285|Secondary|PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11|- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin|0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11||||ng*h/ml||95% Confidence Interval|Mean
1258881|NCT00441285|Secondary|PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1|- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin|0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1|Carbamazepine and Phenytoin were not assigned by the study.|||ng*h / mL||Standard Deviation|Mean
1258882|NCT00441285|Primary|PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11|- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).|0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11||||ng*h/ml||95% Confidence Interval|Mean
1258883|NCT00441285|Primary|PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1|- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).|0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1||||ng*h/mL||95% Confidence Interval|Mean
1258884|NCT00441272|Secondary|Insulin Resistance||48 weeks|||||||
1258885|NCT00441272|Primary|Hepatic Steatosis|Evaluation of the safety and potential benefits of pioglitazone therapy on hepatic steatosis in HIV-infected men and women.|96 weeks|A total of 11 subjects enrolled into the study. 10 were determined to be ineligible during the screening as the Computerized tomography scan revealed a liver-to-spleen ratio > 1 and one was determined ineligible due to concomitant medication use.|||Hounsfeld units||Standard Deviation|Mean
1258886|NCT00441259|Secondary|Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).|Day 42 Post-vaccination|Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1258887|NCT00441259|Secondary|Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).|Day 42 Post Dose 1|Seroprotection was assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.|||Participants|||Number
1258888|NCT00441259|Primary|Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).|Day 42 Post Dose 1|Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1259016|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||Participants|||Number
1258889|NCT00441259|Primary|Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).|Day 42 Post-vaccination|Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population.|||Participants|||Number
1258890|NCT00441259|Primary|Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine||Day 14 up to Day 42 Post-vaccination|Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population.|||Participants|||Number
1258891|NCT00441259|Primary|Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine||Day 14 up to Day 42 Post-vaccination|Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population.|||Participants|||Number
1258892|NCT00441168|Secondary|Duration of Response (DOR)|DOR was defined as the duration from the date of the best confirmed response for subjects who achieved CR or PR to the date of first documented evidence of PD (or relapse for subjects who experienced CR) over the duration of the study. DOR = ([Date of PD or date of censoring – Date of best response]+1)/30.44.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.There was insufficient data to perform Kaplan Meier analysis (data available for 5 subjects in the VAD group and 6 subjects in the PAD group).|||months|||Number
1258893|NCT00441168|Primary|Best Reported Disease Response|The primary efficacy analysis was based on the best response obtained during the treatment period according to the EBMT criteria as assessed by the investigator. The ordering of the responses was: CR, PR, MR, NC and PD. CR was the best response and the poorest response was PD.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.|||participants|||Number
1258894|NCT00441168|Primary|Best Confirmed Disease Response|The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease [PD], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.|||participants|||Number
1258895|NCT00441142|Secondary|PHASE I: To Define the Safety of ZD6474 (Vandetanib) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in This Population.||2 years|||||||
1258896|NCT00441142|Secondary|PHASE II: To Further Evaluate the Safety Profile of ZD6474 (Vandetanib) in Combination With Radiation Therapy and Temozolomide in This Patient Population.||3 years|||||||
1258897|NCT00441142|Secondary|Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free|A secondary outcome of Phase II of this trial is the median progression-free survival (PFS), as calculated by the # of months patients remain progression-free|3 years||||months||95% Confidence Interval|Median
1258898|NCT00441142|Primary|Median Overall Survival (OS) of Phase II Patients|The primary outcome of Phase II of this trial was to determine the efficacy of ZD6474 (Vandetanib) in combination with radiation therapy and concomitant and adjuvant temozolomide in patients with newly-diagnosed GBM and gliosarcomas as measured by overall survival and median survival.|3 years|This measure was only assessed in Participants in Phase II part of the study, who had available data for analysis|||months||95% Confidence Interval|Median
1258899|NCT00441142|Primary|Number of Participants That Experienced a Dose-limiting Toxicity (DLT)|The primary outcome of Phase I of this trial was to determine the maximum tolerated dose (MTD) of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide. The MTD is the dose level at which 0/6 or 1/6 patients experience a dose-limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.|2 years|This measure was only assessed in Participants enrolled into the Phase I part of the study who had available data for analysis.|||Participants|||Number
1258900|NCT00441129|Secondary|Change From Baseline in Total Daily Dose (TDD)|Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline|Baseline and 6 months||||units/day||Standard Deviation|Mean
1258901|NCT00441129|Secondary|Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.|Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline|Baseline and 6 months||||mg/dL||Standard Deviation|Mean
1258902|NCT00441129|Primary|Difference in HbA1C From Baseline and 6 Months|Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline|Baseline and 6 months||||percentage of HbA1C||Standard Deviation|Mean
1258903|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1259017|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment||||Participants|||Number
1258904|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258905|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258906|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258907|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258908|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258909|NCT00441116|Secondary|Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258910|NCT00441116|Secondary|Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258911|NCT00441116|Secondary|Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 3|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258912|NCT00441116|Secondary|Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Baseline|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258913|NCT00441116|Secondary|Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Screening|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258914|NCT00441116|Secondary|Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.|Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)|Baseline and Month 6|Intent to Treat(ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||mg/dL||Standard Deviation|Mean
1258915|NCT00441116|Secondary|Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.|sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||IU/L||Standard Deviation|Mean
1258916|NCT00441116|Secondary|Laboratory Values: Hematology Assessed at Baseline and 6 Months.|Comparing Lab values and differences from Baseline to month 6|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||thousands/microliter||Standard Deviation|Mean
1258917|NCT00441116|Secondary|Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.|Sodium, Potassium (mEq/L), and Bicarbonate|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||mmol/L||Standard Deviation|Mean
1259018|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||Particpants|||Number
1258918|NCT00441116|Secondary|Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10.|Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, <0.1, adult, 0.25-0.75; females (f): prepuberty, <0.03, premenopausal, 0.05-0.3, menopausal, <0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, >20; luteal 5-20; postmenopausal, >10 IU/L.|Baseline to Month 6 and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. LH was only assessed at baseline.|||Participants|||Number
1258919|NCT00441116|Secondary|The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10|Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.|Month 3, Month 6, and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Percent change||Standard Deviation|Mean
1258920|NCT00441116|Secondary|The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10|Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value.|Month 3, Month 6 and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Percent change||Standard Deviation|Mean
1258921|NCT00441116|Secondary|Panel Assessment of Improvement Distribution From Screening|"Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count.~Score Range -3=greatly decreased to +3=greatly increased. 0=No change."|Baseline to Month 3 and Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
1258922|NCT00441116|Secondary|Investigator's Photographic Assessment of Improvements From Baseline Score|Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change.|Month 3 and Month 6|Per Protocol Population (PP) defined as subjects in the ITT population taking study medication for 6 month and no identified as a major protocol violator.|||units on a scale||Standard Deviation|Mean
1258923|NCT00441116|Secondary|Investigator's Photographic Assessment of Improvement Distribution From Baseline|Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
1258924|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
1258925|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
1258926|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
1258927|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
1258928|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
1258929|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
1259019|NCT00440466|Other Pre-specified|Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||g/dL||Standard Deviation|Mean
1293196|NCT00100698|Secondary|Change in Body Mass Index|Change in body mass index|18 months||||kilogram/meters squared||Standard Error|Mean
1258930|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258931|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
1258932|NCT00441116|Secondary|Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.|The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.|Baseline and Month 3|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||hair count per centimeters squared||Standard Deviation|Mean
1258933|NCT00441116|Primary|Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.|The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.|Baseline and 6 months|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||hair count per centimeters squared||Standard Deviation|Mean
1258934|NCT00441103|Secondary|Number of CU Active MRI Lesions|CU active lesions were defined as a unique newly active or persistently active lesion on the PD/T2 scan or the gadolinium enhanced T1 scan (with a method to avoid double counting).|Up to Week 40|ITT population included all randomized participants who received at least one dose of study drug.|||lesions||Standard Deviation|Mean
1258935|NCT00441103|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs were categorized based upon the treatment period during which they occurred, that is, double-blind period (up to Week 16) and rater-blind period (Week 17 up to Week 40).|Baseline up to Week 40|Safety population included all randomized participants who received at least one dose of study drug. Here, 'n' signifies those participants who were evaluable for the specified category.|||participants|||Number
1258936|NCT00441103|Secondary|Mean Number of CU Lesions Per Scan Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Participants, Originally Randomized to Placebo.|"CU active lesions were defined as a unique newly active or persistently active lesion on the PD/T2 scan or the gadolinium enhanced T1 scan (with a method to avoid double counting). Only Placebo Followed by RNF arm was evaluable for this outcome measure."|Day 1 up to Week 16 and Week 17 up to Week 40|"ITT population included all randomized participants who received at least one dose of study drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||lesions||Standard Deviation|Mean
1258937|NCT00441103|Primary|Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16|CU active lesions were defined as a unique newly active or persistently active lesion on the protocol density/time constant 2 (PD/T2) scan or the gadolinium (Gd-) enhanced time constant 1 (T1) scan (with a method to avoid double counting).|16 Weeks|ITT population included all randomized participants who received at least one dose of study drug.|||lesions||Standard Deviation|Mean
1258938|NCT00441090|Other Pre-specified|To Evaluate the Pharmacokinetics (PK) and the Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship of Avatrombopag in Patients With ITP.|Given the sparse PK sampling in this study, PK data from outside studies, which includes healthy subjects, were included to assist in PK model development. As a result this data was not reported with these study results.|Days 7, 14, 21 and 28|Given the sparse PK sampling in this study, PK data from outside studies, which includes healthy subjects, were included to assist in PK model development. As a result this data was not reported with these study results.||||||
1258939|NCT00441090|Secondary|Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit|Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.|Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
1258940|NCT00441090|Secondary|Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit|Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.|Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
1259020|NCT00440466|Other Pre-specified|Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||Participants|||Number
1258941|NCT00441090|Secondary|Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit|Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.|Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
1258942|NCT00441090|Secondary|Responder Rate to Avatrombopag by Visit|Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, and 21. The RR was summarized by treatment group using the method of LOCF. Day 28 was not included with this data because it was reported as a primary outcome measure.|Day -4 to Day 1, Baseline, Day 7, Day 14, and Day 21|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
1258943|NCT00441090|Secondary|Change in Platelet Count From Baseline|"Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28. The unit of measure was K/mm^3, where K = platelets x 1000 = platelets x 10^3 and mm^3 = cubic milliliter= microliter."|Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, Day 28|Full Analysis population, LOCF|||platelets x 10^3/mm^3||Standard Deviation|Mean
1258944|NCT00441090|Primary|Responder Rate (RR) to Avatrombopag on Day 28|Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Day 28. The RR was defined as the percentage of participants with a Day 1 platelet count of less than 30,000/milliliter (mL) who reached a platelet count of greater than or equal to 50,000/mL on Day 28 of study medication, together with the percentage of participants using steroids who had a Day 1 platelet count greater than or equal to 30,000/mL but less than 50,000/mL who reached a platelet count of greater than or equal to 20,000/mL higher than their Day 1 platelet count on Day 28 of study medication. The RR was summarized by treatment group using the method of last observation carried forward (LOCF).|Day-4 to Day 1, Baseline, Day 28|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
1258945|NCT00441064|Secondary|Percentage of Responders Defined as MASBP <130 mm Hg or a Decrease From Baseline in MASBP of ≥20 mm Hg in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|To evaluate the percentage of responders defined as MASBP < 130 mm Hg or a decrease in MASBP from baseline of ≥20 mm Hg in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. Percent response for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and Week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets|||Percentage of responders|||Number
1258946|NCT00441064|Secondary|Mean 24 Hour Ambulatory Diastolic Blood Pressure (MADBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|To evaluate the mean 24 hour ambulatory diastolic blood pressure (MADBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MADBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets|||mm Hg||Standard Deviation|Mean
1258947|NCT00441064|Primary|Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|The primary objective of the study was to assess mean 24 hour ambulatory systolic blood pressure (MASBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets|||mm Hg||Standard Deviation|Mean
1258948|NCT00441012|Secondary|The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.|Geometric Mean Titer (GMT) – This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||µg /mL||95% Confidence Interval|Geometric Mean
1258949|NCT00441012|Secondary|The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.|"The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after~the third dose)"|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
1258950|NCT00441012|Secondary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences|Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)|0-11 months (recorded from first dose until the participant completes or discontinues)|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up.|||Participants|||Number
1258951|NCT00441012|Primary|The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.|Geometric Mean Titer (GMT) – This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
1258952|NCT00441012|Primary|The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
1258953|NCT00440947|Secondary|Mean Percent Compliance at Week 144|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 144|ITT-Extension Population, Extension Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.|||percent compliance||Standard Deviation|Mean
1258954|NCT00440947|Secondary|Mean Percent Compliance at Week 84|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 84|ITT-E Population, Randomized Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.|||percent compliance||Standard Deviation|Mean
1258955|NCT00440947|Secondary|Mean Percent Compliance at Week 36|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 36|ITT-E Population, Induction Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.|||percent compliance||Standard Deviation|Mean
1258956|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Week 84 through Week 144|Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure phenotypic evaluations|||participants|||Number
1258957|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Randomization at Week 36 through Week 84|Participants in the ITT-E population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.|||participants|||Number
1258958|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Baseline through Week 36|Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.|||participants|||Number
1258959|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Week 84 through Week 144|Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations.|||participants|||Number
1259011|NCT00440505|Secondary|Number of Participants Who Reported an Increase in Daily Pain Medication Regime|Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.|1 day|This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.|||Participants|||Number
1258960|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Randomization at Week 36 through Week 84|Participants in the ITT-E Population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.|||participants|||Number
1258961|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Baseline through Week 36|Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.|||participants|||Number
1258962|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 144|A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.|Baseline and Week 144|ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a cell count obtained during that visit period.|||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
1258963|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 84|A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.|Baseline and Week 84|ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a cell count obtained during that visit period.|||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
1258964|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 36|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value.|Baseline and Week 36|ITT-E Population, Induction Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 36 visit and had a cell count obtained during that visit period.|||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
1258965|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 144|Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 144|ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a viral load result obtained during that visit period.|||log10 c/ml||Standard Deviation|Mean
1258966|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 84|Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 84|ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a viral load result obtained during that visit period.|||log10 c/ml||Standard Deviation|Mean
1258967|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 36|Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 36|ITT-E Population, Induction Phase. Observed Population. Participants could only be included in the analysis if they had completed a Week 36 visit and had a viral load result obtained during that visit period.|||log10 c/ml||Standard Deviation|Mean
1258968|NCT00440947|Secondary|Number of Participants Who Met the PDVF Criteria at Week 144|The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 144|ITT-Extension Population, Extension Phase. TLOVR.|||participants|||Number
1258969|NCT00440947|Secondary|Number of Participants Who Met the PDVF Criteria at Week 84|The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 84|ITT-Exposed Population, Randomized Phase. TLOVR. One participant met PDVF criteria at Week 36 and was included in the Week 36 PDVF but had been randomized; this participant is therefore also included in this PDVF tabulation.|||participants|||Number
1258970|NCT00440947|Secondary|Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36|The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 36|ITT-E Population, Induction Phase|||participants|||Number
1258971|NCT00440947|Secondary|Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit|Percentage of PAR with HIV-1 RNA <400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 144|ITT-Extension Population, Extension Phase|||percentage of participants|||Number
1258972|NCT00440947|Secondary|Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit|Percentage of PAR with HIV-1 RNA <400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 84|ITT-E Population, Randomized Phase|||percentage of participants|||Number
1258973|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit|The percentage of PAR with HIV-1 RNA virus <400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 36|ITT-E Population, Induction Phase|||percentage of participants|||Number
1258974|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit|Percentage of PAR with HIV-1 RNA <50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 144|ITT-Extension Population, Extension Phase: all participants exposed to at least one dose of study medication during the Extension Phase of the study|||percentage of participants|||Number
1258975|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit|A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA <50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures.|Week 84|ITT-E Population, Randomized Phase. The secondary analysis methods were Observed (Obs) and missing/discontinuation=failure (M/D=F) analyses.|||percentage of participants|||Number
1258976|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit|The percentage of PAR with HIV-1 RNA virus <50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures.|Week 36|ITT-E Population, Induction Phase: all participants exposed to at least one dose of study medication during the Induction Phase of the study|||percentage of participants|||Number
1258977|NCT00440947|Secondary|Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase|The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.|Baseline of Randomized Phase|ITT-E Population: all participants exposed to at least one dose of study medication during the Randomized Simplification Phase|||years||Standard Deviation|Mean
1258978|NCT00440947|Primary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit|The percentage of PAR with HIV-1 RNA virus <50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 c/ml and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.|Week 84|Intent-to-Treat (ITT)-Exposed Population, Randomized Phase: all PAR exposed to at least one dose of study medication during the Randomized Phase of the study. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of PAR with HIV-1 RNA <50 c/ml at Week 84 in the Simplification arm and Continuation arms|||percentage of participants|||Number
1258979|NCT00440830|Primary|Postoperative Pain Score Five Days After Surgery|Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.|5 days||||Numeric Rating Scale (NRS)||Standard Deviation|Mean
1258980|NCT00440830|Secondary|Heart Rate|Heart rate reported in Beats per minute (BPM)|1 hour after surgery|||||||
1258981|NCT00440830|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery|||||||
1258982|NCT00440830|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery|||||||
1258983|NCT00440830|Secondary|Pain Medication Used|Pain medication used after surgery in morphine equivalents|5 days|||||||
1258984|NCT00440830|Secondary|Sedation|Observer's Assessment of Alertness/Sedation Scale was used to report sedation.|1 hour after surgery|||||||
1258985|NCT00440830|Secondary|Nausea Assessment by Patient|Nausea scale range: 0=none and 10=the worst, ordinal.|1 hour after surgery|||||||
1258987|NCT00440700|Secondary|Urinary Cortisol|Stress was measured by the biomarker urinary cortisol. 24-hour urine collections were obtained from eligible participants who were not receiving steroids or other medications known to affect cortisol and who had intact renal function. 24-hour urinary cortisol results were used as an integrative measure of stress (mg/day).|Daily up to 30 days|All participants with functioning kidneys who were not receiving steroids or other medications known to affect cortisol and who had two or more 24-hour urine collections were included in the analysis.|||total milligrams per day||Full Range|Median
1258988|NCT00440700|Secondary|Length of Mechanical Ventilatory Support|Length of mechanical ventilatory support was defined as the number of days from initial intubation and placement on mechanical ventilation to the day of extubation or death for participants in each group.|From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.|Includes all subjects enrolled regardless of length of protocol participation. Mean number of days mechanically ventilated was calculated for the subjects randomized to each group/arm.|||days||Standard Error|Mean
1258989|NCT00440700|Secondary|Length of ICU Stay|Length of ICU stay was measured in days from the first day participant was admitted to the unit until discharged, transferred, or died in the ICU. This was the total time that any participant was in the intensive care unit which could have been longer than the 30 study protocol .|From date of ICU admission to extubation or discharge or date of death from any cause, whichever came first assessed up to 60 days|The number of participants includes all of those patients who were enrolled into the study protocol, regardless of their length of study participation.|||days||Standard Error|Mean
1258990|NCT00440700|Primary|State Anxiety|"Participants reported their current level of anxiety each day enrolled in the study in response to the question how are you feeling today/ The Visual analog scale-anxiety was used to evaluate the self-report of anxiety. Scores range from 0 = not anxious at all to 100 = the most anxious ever. Higher numbers indicate greater anxiety. Daily anxiety scores from all subjects were combined and analyzed for each group resulting in an overall mean anxiety score at the end of the study protocol of 30 days."|Daily up to 30 days|Participants with 3 or more visual analog scale-anxiety ratings were included in the analysis.|||units on a scale||Standard Deviation|Mean
1258991|NCT00440700|Primary|Sedative Exposure|Sedative exposure was measured by: 1) the number (dose frequency) of sedative medication doses administered in a 4-hour time period each day and 2) by an aggregate dose intensity of sedative medications administered in a 4-hour time period each day based on all subjects receiving sedative medications on any individual study day yielding a sedation intensity score. A sedation intensity score was calculated for each study group each study protocol day, up to 30 days. Higher sedation intensity scores indicate more sedative exposure. If a subject did not receive any sedation, the sedative exposure score is zero for that respective day.|Daily up to 30 days|Participants with 2 or more days of study enrollment data were included in the analysis for this aim.|||exposures/4-hours per day||Full Range|Median
1258992|NCT00440557|Secondary|Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.|From baseline to Week 9|Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization Hb concentration measurement.|||participants|||Number
1258993|NCT00440557|Post-Hoc|Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment|Change is calculated as mean hemoglobin (Hb) over last 8 wks subtracts baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Max Hb RR observation was identified for each participant during the 1st 22 wks of treatment. This was the max RR in hemoglobin over any 2-wk period per participant.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||g/dL/2 weeks||Standard Deviation|Mean
1258994|NCT00440557|Other Pre-specified|Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||participants|||Number
1258995|NCT00440557|Other Pre-specified|Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||participants|||Number
1258996|NCT00440557|Other Pre-specified|Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all subjects who received at least 1 injection of study drug.|||participants|||Number
1258997|NCT00440557|Other Pre-specified|Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||g/dL||Standard Deviation|Mean
1259021|NCT00440466|Secondary|Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)||Weeks 13-37|Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.|||Proportion||Full Range|Median
1258998|NCT00440557|Other Pre-specified|Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||participants|||Number
1258999|NCT00440557|Primary|Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.|From baseline through Week 22|Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization hemoglobin concentration measurement.|||g/dL||Standard Deviation|Mean
1259000|NCT00440531|Secondary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences||During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)|Safety Analysis Set – defined as all participants who received at least one injection of vaccine and who had a safety follow-up.|||Participants|||Number
1259001|NCT00440531|Secondary|The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C||Day 1-5 After Vaccination|Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up.|||Participants|||Number
1259002|NCT00440531|Secondary|The Total Number of Participants With One or More Injection-site Adverse Experiences||Days 1-5 After Any Vaccination|Safety Analysis Set – defined as all participants who received at least one injection of vaccine and who had a safety follow-up.|||Participants|||Number
1259003|NCT00440531|Secondary|The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).|7 months (1 month after third vaccination)|Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
1259004|NCT00440531|Primary|The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).|7 months (1 month after third vaccination)|Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
1259005|NCT00440518|Secondary|Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)|Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person’s ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject’s quality of life.|Baseline, last visit in the 17-week Trial Period|Of the 71 (Placebo), 70 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects in the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value), 64, 66, and 66 subjects respectively are included in this summary.|||Scores on a scale||Standard Deviation|Mean
1259006|NCT00440518|Secondary|Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.||Baseline, last 4 weeks of the 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.|||Participants|||Number
1259007|NCT00440518|Secondary|Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.||Baseline, Entire 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.|||Participants|||Number
1259008|NCT00440518|Secondary|Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period||Baseline, last 4 weeks of the 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.|||Number of migraine headaches||Standard Deviation|Mean
1259009|NCT00440518|Primary|Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period||Baseline, Entire 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.|||Number of migraine headaches||Standard Deviation|Mean
1259010|NCT00440505|Secondary|Nausea|Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.|1 day|This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1259012|NCT00440505|Secondary|Patient Self-assessment of Psychological Distress|Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.|1 day|This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.|||Units on a scale||Standard Deviation|Mean
1259022|NCT00440466|Primary|Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment||from baseline (Week 1) to the last 12 weeks of treatment|Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.|||g/dL||Standard Deviation|Mean
1259023|NCT00440401|Secondary|Proportion of Subjects Achieving Haemostasis at 6 Minutes.|Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.|6 minutes|"Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined as randomised and the Safety population (= basis for Adverse Events analyses) was defined as treated."|||Proportion of Subjects||95% Confidence Interval|Number
1259024|NCT00440401|Primary|Proportion of Subjects Achieving Haemostasis at 3 Minutes|Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.|3 minutes|"Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined as randomised and the Safety population (= basis for Adverse Events analyses) was defined as treated."|||Proportion of Subjects||95% Confidence Interval|Number
1259025|NCT00440310|Primary|Overall Survival|Time from randomization to death|Up to 184 weeks|ITT (All patient randomized/enrolled)|||Days||Inter-Quartile Range|Median
1259026|NCT00440297|Primary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences|Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).|0-9 months (recorded from first dose until the participant completes or discontinues the study)|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up|||Participants|||Number
1259027|NCT00440297|Primary|The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C||Days 1-5 After Any Vaccination|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up|||Participants|||Number
1259028|NCT00440297|Primary|The Total Number of Participants With One or More Injection-Site Adverse Experiences||Days 1-15 After Any Vaccination|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up|||Participants|||Number
1259029|NCT00440297|Primary|The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9|"The number of participants as measured by the~seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose)."|9 months (1 month after the fourth dose)|"Per-Protocol Population: The Per-~Protocol Population is defined as the participants that were able to complete the study as defined by the~protocol."|||Participants|||Number
1259030|NCT00440297|Primary|The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7|"The number of participants as measured by the~seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose)."|7 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
1259031|NCT00440271|Secondary|Post-dose TPV and RTV Concentrations at Week 4||Week 4|||||||
1259032|NCT00440271|Secondary|Occurrence of TPV Trough Concentration >120 μM||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259033|NCT00440271|Secondary|Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259034|NCT00440271|Secondary|Patients Adherence With Study Medication Based on Pill Count||after 4 weeks of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259035|NCT00440271|Secondary|Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259036|NCT00440271|Secondary|Change in Ratio of CD38+/CD8+ From Baseline to Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259037|NCT00440271|Secondary|Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259038|NCT00440271|Secondary|Time to New AIDS or AIDS Related Progression Event or Death||after Day 1 of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259175|NCT00439335|Secondary|Number of Participants Achieving a HAI Titer of Greater Than or Equal to 40 After Dose 2|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine|Approximately Day 56||||Participants|||Number
1259039|NCT00440271|Secondary|Time to Treatment Failure|For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.|after Day 1 of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259040|NCT00440271|Secondary|Change in Viral Load From Baseline at Each Visit||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259041|NCT00440271|Secondary|Percentage of Participants Whose ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259042|NCT00440271|Secondary|Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259043|NCT00440271|Secondary|Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259044|NCT00440271|Primary|Treatment Response at Week 48|percentage of participants whose viral load <50 copies/mL at Week 48|after 48 weeks of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
1259045|NCT00440232|Secondary|Time to Development of Headache of Any Intensity|Time to development of headache of any intensity in the 2 treatment arms|20 hours||||hours||95% Confidence Interval|Mean
1259046|NCT00440232|Primary|Incidence of Fasting-induced Headache of Any Intensity|Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting|20 hours||||participants|||Number
1259047|NCT00440193|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding, cardiovascular death, myocardial infarctions, stroke, or non CNS systemic embolism. Major bleeding was associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography ( PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259048|NCT00440193|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death, cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events confirmed by independent committee blinded to treatment, based on compression ultrasound, venography, spiral CT scan, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy, results/films/images of confirmatory testing and/or case summaries|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259049|NCT00440193|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259050|NCT00440193|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1283006|NCT00234286|Secondary|Individuals Administered of Opioid Medication|Administration of opioid medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1259051|NCT00440193|Other Pre-specified|Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259052|NCT00440193|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259053|NCT00440193|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259054|NCT00440193|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259055|NCT00440193|Secondary|Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)|All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
1259056|NCT00440193|Secondary|Percentage of Participants With All Deaths|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
1259057|NCT00440193|Secondary|Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
1259176|NCT00439335|Secondary|HAI Geometric Mean Titer (GMT) After Dose 2|HAI geometric mean titer (GMT) against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine.|Approximately Day 56.||||Antibody Titer||95% Confidence Interval|Geometric Mean
1259058|NCT00440193|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259059|NCT00440193|Secondary|Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259060|NCT00440193|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259061|NCT00440193|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259062|NCT00440180|Primary|Pregnancy Rate|Partner pregnancy rate during study participation|4 months||||participants partner|||Number
1259063|NCT00440115|Secondary|Progress in Stage of Change|Progress in Stages of Change at 6, 12, 18, and 24 months|6, 12, 18, 24 months||||Participants|||Count of Participants
1259064|NCT00440115|Secondary|Number of Quit Attempts|Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period.|6, 12, 18, 24 months||||quit attempts|||Number
1259065|NCT00440115|Primary|7-day Point Prevalence Abstinence From Cigarettes|Self-reported 7-day point prevalence abstinence from cigarettes|24 months|We used generalized linear models for the primary endpoint (self-reported abstinence at 24 months). Missing values were imputed as smokers, deaths and incarcerations were excluded from analysis.|||Participants|||Count of Participants
1259066|NCT00440050|Secondary|Neuropsychiatric Inventory (NPI)|The Neuropsychiatric Inventory quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, sleep change, appetite change, and others. This is a structured questionnaire administered to the subject's caregiver/study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment.|18 months||||Units on a scale||Standard Deviation|Mean
1259067|NCT00440050|Secondary|ADCS-ADL|ADCS-ADL = Alzheimer's Disease Cooperative Study Activities of Daily Living Score. This is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 6 with lower numbers indicating greater impairment.|18 months||||Units on a scale||Standard Deviation|Mean
1259068|NCT00440050|Primary|Rate of Change on CDR-SOB|CDR-SOB = Clinical Dementia Rating, Sum of Boxes. This is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.|18 months||||Units on a scale||Standard Deviation|Mean
1259069|NCT00440050|Primary|Rate of Change on the ADAS-Cog 11.|ADAS-cog 11 = Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year. This is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.|Baseline, 6, 12, 18 months||||ADAS points per year||Standard Deviation|Mean
1259070|NCT00440011|Secondary|Tolerability - Conjunctival Hyperemia|Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)|Month 3||||participants|||Number
1259071|NCT00440011|Primary|Intraocular Pressure (IOP)|Intraocular Pressure|Month 3||||mm Hg||Standard Deviation|Mean
1259072|NCT00439946|Secondary|Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)|A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.|Week 8||||participants|||Number
1259073|NCT00439946|Secondary|Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)|The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua (e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Baseline and Week 8|All 8 participants are included.|||units on a scale||Standard Deviation|Mean
1259074|NCT00439946|Secondary|Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL. The CAMPHOR was completed at Baseline and at Week 8. The CAMPHOR consists of 3 scales: 1. A 25-item overall symptoms scale scored 0–25, with a higher score indicating the presence of more symptoms. 2. A 15 item Activity/Functioning scale scored 0–30, where a low score indicates good functioning. 3. A 25-item QoL scale scored 0–25, with a high score indicating poor QoL. Additionally, a total score was recorded by adding up the the scores from the 3 above scales. The Symptom and QoL scales have dichotomous (‘True’/‘Not true’) response options while the Activity/Functioning scale has three-point (‘Able to do on own without difficulty’/‘Able to do on own with difficulty’/‘Unable to do on own’) response options. Reduction in score denotes improved heath status.|Baseline and Week 8|One subject was missing a questionnaire page of the CAMPHOR; Therefore, the component score of|||units on a scale||Standard Deviation|Mean
1259075|NCT00439946|Secondary|Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol|A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin.|Week 8||||minutes||Standard Deviation|Mean
1259076|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Chest Pain|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
1259077|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Syncope|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
1259078|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Dizziness|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
1259079|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Orthopnea|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included|||participants|||Number
1259080|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Edema|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included|||participants|||Number
1259081|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included|||participants|||Number
1259082|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Fatigue|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
1259083|NCT00439946|Secondary|Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification|WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
1259084|NCT00439946|Secondary|Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Week 8|Two subjects did not have Baseline Borg scores and were excluded from this analysis.|||units on a scale||Standard Deviation|Mean
1259085|NCT00439946|Primary|Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)|The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002].|Week 8|Two subjects did not have Baseline 6MWTs and were excluded from this analysis.|||meters||Standard Deviation|Mean
1259114|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent PE During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259086|NCT00439777|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259087|NCT00439777|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259088|NCT00439777|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259089|NCT00439777|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259090|NCT00439777|Other Pre-specified|Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259091|NCT00439777|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259100|NCT00439777|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259092|NCT00439777|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
1259093|NCT00439777|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259094|NCT00439777|Secondary|Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)|All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
1259095|NCT00439777|Secondary|Percentage of Participants With All Deaths|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
1259096|NCT00439777|Secondary|Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
1259097|NCT00439777|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259098|NCT00439777|Secondary|Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259099|NCT00439777|Secondary|Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259101|NCT00439777|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259102|NCT00439738|Secondary|Change From Baseline in Postprandial Non-esterified Fatty Acids|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis|||mg/dL||Standard Deviation|Mean
1259103|NCT00439738|Secondary|Change From Baseline in Postprandial Insulin|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis|||mg/dL||Standard Deviation|Mean
1259104|NCT00439738|Secondary|Change From Baseline in Postprandial Glucose|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis.|||mg/dL||Standard Deviation|Mean
1259105|NCT00439738|Secondary|Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)|Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg|Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)|Intent to Treat (ITT)|||participants|||Number
1259106|NCT00439738|Secondary|Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)|Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg|Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)|Intent to Treat (ITT)|||participants|||Number
1259107|NCT00439738|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline to Weeks 4, 8, 12 and 16|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1259108|NCT00439738|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline to Week 8|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1259109|NCT00439725|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound or venography, results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259110|NCT00439725|Other Pre-specified|Percentage of Participants With Recurrent VTE (PE or DVT) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259111|NCT00439725|Other Pre-specified|Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period|Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units, occurring in a critical site or contributing to death.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259112|NCT00439725|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259113|NCT00439725|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1283398|NCT00227370|Secondary|Any CMV Infection|Inclusive of CMV syndrome, disease, or infection not meeting primary end point.|over the course of 300 days post randomization|intention to treat|||participants|||Number
1259115|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259116|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259117|NCT00439725|Other Pre-specified|Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259118|NCT00439725|Other Pre-specified|Percentage of Participants With Death (PE) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259119|NCT00439725|Secondary|Percentage of Participants With Other Vascular Events|All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day)|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.|||Percentage of participants|||Number
1259120|NCT00439725|Secondary|Percentage of Participants With All Death|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.|||Percentage of participants|||Number
1259121|NCT00439725|Secondary|Percentage of Participants With Clinically Relevant Bleeding|All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication [‘time window: 2 days’]) and all events post randomization were reported|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.|||Percentage of participants|||Number
1259122|NCT00439725|Secondary|Percentage of Participants With Major Bleeding|All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported.|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.|||Percentage of participants|||Number
1259123|NCT00439725|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259124|NCT00439725|Secondary|Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259125|NCT00439725|Secondary|Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259126|NCT00439725|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259127|NCT00439725|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), or lung scintigraphy (for PE), and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259128|NCT00439725|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. For definition of DVT/PE, kindly refer to the link in the Protocol section.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
1259129|NCT00439673|Secondary|Time to Transformation to AML||At 60 months||||months||95% Confidence Interval|Median
1259130|NCT00439673|Primary|The Primary Objective of the Trial is to Assess the Efficacy of the Combined Use of Valproic Acid (VPA) in Combination With 5-Azacytidine (5-Aza C) in the Treatment of MDS.|Overall survival|At 60 months||||months||95% Confidence Interval|Median
1259131|NCT00439647|Secondary|Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits||Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24|The ITT, Intent to Treat population, includes all participants who received a single a dose of treatment and had data available for analysis. n = the number of subjects with evaluable measurements at visit, as determined by the efficacy window.|||ng/mL||Standard Error|Mean
1259132|NCT00439647|Secondary|Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total femoral neck BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.|||Percent change in BMD||Standard Error|Least Squares Mean
1259133|NCT00439647|Secondary|Percentage Change From Baseline in Total Hip BMD (g/CM^2)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total hip BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.|||Percent change in BMD||Standard Error|Least Squares Mean
1259171|NCT00439335|Secondary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers 7 Months After Dose 1.|Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.|Approximately Day 208||||Participants|||Number
1259207|NCT00439218|Secondary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Area under the plasma concentration versus time curve (AUC)|12 weeks||||µmol/L * hours||Standard Deviation|Mean
1259134|NCT00439647|Secondary|Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in BMD at lumbar spine at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.|||Percent change in BMD||Standard Error|Least Squares Mean
1259135|NCT00439647|Secondary|Number of Participants With First Non-vertebral Fracture|Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.|||Participants|||Number
1259136|NCT00439647|Secondary|Number of Participants With First Clinical Fracture|Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.|||Participants|||Number
1259137|NCT00439647|Secondary|Number of Participants With First Clinical Vertebral Fracture|Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.|||Participants|||Number
1259138|NCT00439647|Secondary|Mean Change in Height From Baseline|Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis|from Baseline to 12 months and 24 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||mm||Standard Error|Mean
1259139|NCT00439647|Secondary|Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months|Worsening vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)|Baseline, Month 24|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF.|||Percentage of Participants|||Number
1259140|NCT00439647|Secondary|Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months|Worsening vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)|Baseline, 12 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||Percentage of Participants|||Number
1259141|NCT00439647|Secondary|Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months|Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.|24 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||Percentage of participants|||Number
1259142|NCT00439647|Secondary|Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months|Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.|12 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||Percentage of participants|||Number
1259143|NCT00439647|Secondary|Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months|Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height|12 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||Percentage of participants|||Number
1259144|NCT00439647|Primary|Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months|Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height|24 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF.|||Percentage of Participants|||Number
1259145|NCT00439608|Secondary|Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach.|CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity.|baseline, then during treatment, about 5 weeks through 30 days post treatment.|60 patients were analyzed for toxicity but 57 for overall response.|||participants|||Number
1259146|NCT00439608|Primary|Reponse Rate at Time of Surgery by Tissue|pathologic complete response rate at surgery|within 30 days of last treatment||||participants|||Number
1259147|NCT00439569|Secondary|Overall Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses within each study visit interval were considered compliant.|12 Weeks|Four of the nine subjects enrolled were less than 80% compliant. The study was closed prematurely due to poor compliance with study drug administration.|||Participants|||Number
1259148|NCT00439569|Secondary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Area Under the Plasma Concentration versus Time curve (AUC)|12 weeks||||µmol/L * hours||Standard Deviation|Mean
1259149|NCT00439569|Primary|Survival Motor Neuron (SMN) Protein|The change of level in blood SMN protein from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||Change in SMN Protein level||Standard Deviation|Mean
1259150|NCT00439569|Secondary|Pharmacokinetic Parameters (Time to Maximum Concentration)|Time to Maximum Concentration (Tmax)|12 weeks||||Hours||Standard Deviation|Mean
1259151|NCT00439569|Secondary|Pharmacokinetic Parameters (Maximum Plasma Concentration)|Maximum Plasma Concentration (Cmax)|12 weeks||||µM||Standard Deviation|Mean
1259152|NCT00439569|Secondary|Drug Safety|Adverse event(AE)monitoring|14 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of subjects enrolled. There were no safety concerns reported by the study monitoring committee (SMC).|||Adverse Events|||Number
1259153|NCT00439569|Primary|Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA)|The change of level in blood SMN mRNA from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||Change in mRNA level||Standard Error|Mean
1259154|NCT00439569|Primary|Dose Limiting Toxicities (DLT)|Number of DLTs to determine the maximum tolerated dosage. A DLT is defined as any Grade (GR)3 or higher adverse event(AE),GR 1 or higher cardiac arrhythmia;GR 2 or higher vomiting;GR 2 or higher liver dysfunction/failure (clinical);GR 2 elevation of amylase or lipase accompanied by clinical symptoms of pancreatitis.The following GR 2 events are classified as DLTs if evaluated to be clinically significant by the principal investigator or medical safety monitor:decrease of hemoglobin, WBCs, platelets; elevation of AST, ALT,bilirubin;abnormality of Na, K, Cl, Ca, HCO3, glucose, BUN or creatinine.|29 Days|The study was closed prematurely due to poor compliance with study drug administration. The MTD could not be determined as it was less than the lowest dosage studied (500 mg/kg/day).|||DLT(s)|||Number
1259155|NCT00439517|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|Safety population|||participants|||Number
1259156|NCT00439517|Secondary|Treatment Impact on Social Daily Living and Health Care Resource Utilization|Non-protocol medical care visits and consultations|From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009|ITT population|||visits or consultations|||Number
1259157|NCT00439517|Secondary|QOL Therapy Preference Questionnaire (TPQ)|TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.|at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays|"Patients were considered evaluable for TPQ provided they had at least one evaluable TPQ questionnaire and they were also included in the ITT TPQ subset population.~The most essential characteristics of a cancer medication score are shown at baseline and cycle 3, no further cycles are available due to the low number of patients in later cycles"|||percentage of participants|||Number
1259172|NCT00439335|Secondary|Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 After Dose 1.|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose of vaccine.|Approximately Day 28||||Participants|||Number
1259173|NCT00439335|Secondary|HAI GMT After Dose 1|HAI GMT against influenza A/H5N1 virus one month after receipt of the first dose of vaccine.|Approximately Day 28||||Antibody titer||95% Confidence Interval|Geometric Mean
1259174|NCT00439335|Secondary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 1.|Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose.|Approximately Day 28||||Participants|||Number
1259158|NCT00439517|Secondary|QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire|The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.|at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays|Patients were considered evaluable for EQ-5D provided they had at least one evaluable EQ-5D questionnaire and provided that they were also included in the ITT Population.|||scores on a scale||Standard Error|Least Squares Mean
1259159|NCT00439517|Secondary|Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)|All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0=”Not at all” to 4=”Very much”. For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL.|At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays|Patients were considered evaluable for FACT-C provided they had at least one evaluable FACT-C questionnaire and provided that they were also included in the ITT Population|||scores on a scale||Standard Error|Least Squares Mean
1259160|NCT00439517|Secondary|Overall Survival (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011|ITT population i.e. all randomized subjects.|||months||95% Confidence Interval|Median
1259161|NCT00439517|Secondary|Overall Survival (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|ITT population i.e. all randomized subjects.|||months||95% Confidence Interval|Median
1259162|NCT00439517|Secondary|Best Overall Response (BOR)|"BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as Disappearance of all target lesions plus disappearance of all non-target lesions & without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later"|Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|ITT population i.e. all randomized subjects.|||percentage of participants||95% Confidence Interval|Number
1259163|NCT00439517|Primary|Progression-free Survival (PFS)|Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria|Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|Intention-to-treat (ITT) population i.e. all randomized subjects .|||months||95% Confidence Interval|Median
1259164|NCT00439413|Secondary|Abstinence|The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.|week 14||||participants|||Number
1259165|NCT00439413|Primary|Quit Rate|The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).|Study weeks 6 through 9||||participants|||Number
1259166|NCT00439335|Primary|Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.|The number of participants reporting pain, tenderness, itching, induration, erythema, and pigmentation. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.|7 days after each vaccination||||Participants|||Number
1259167|NCT00439335|Primary|Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.|The number of participants reporting fever, feverishness, malaise, myalgia, headache and nausea. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.|7 days after each vaccination||||Participants|||Number
1259168|NCT00439335|Primary|Occurrence of Unsolicited Symptoms During a 28-day Surveillance Period Following Vaccinations at Days 0 and 28.|The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 28 days of vaccination. Participants are counted only once but may have experienced events on multiple occasions.|Through approximately Day 56||||Participants|||Number
1259169|NCT00439335|Secondary|Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 at 7 Months After Dose 1.|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 7 months after receipt of the first dose of vaccine.|Approximately Day 208||||Participants|||Number
1259170|NCT00439335|Secondary|HAI GMT at 7 Months After Dose 1|HAI GMT against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.|Approximately Day 208||||Antibody Titer||95% Confidence Interval|Geometric Mean
1284701|NCT00201240|Secondary|Transplant Related Mortality|Death occurring in a patient in continuing complete remission.|Months 12, 24, and 36||||percentage of participants||95% Confidence Interval|Number
1259177|NCT00439335|Primary|Number of Participants Spontaneously Reporting Any Serious Adverse Event.|Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.|Through Day 208.||||Participants|||Number
1259178|NCT00439335|Primary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 2|Number of participants in each vaccine group achieving a 4-fold or greater increase in serum hemagglutination inhibition (HAI) antibody titers against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine|Approximately Day 56.||||Participants|||Number
1259179|NCT00439309|Secondary|Time to Wound Closure|Time to wound closure was defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. This endpoint was analyzed using the log-rank test to compare the two treatment groups. The Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group.|From initial clamp removal at the last anastomotic site until skin closure||||Minutes||95% Confidence Interval|Median
1259180|NCT00439309|Secondary|Time to Hemostasis|Time to hemostasis determined from time circulation restored after treatment application until bleeding stopped (assessed at intervals of immediate, 1, 3, 5, 7.5 and 10 min). For subject with two sites, time to hemostasis of both sites used for analysis. Subjects for whom bleeding had not stopped within 10 min considered censored observations.|Within 10 minutes post restoration of blood flow||||Minutes||95% Confidence Interval|Median
1259181|NCT00439309|Secondary|Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)|A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow.|Within 10 minutes post restoration of blood flow||||percentage of anastomitic sites|Anastomosis||Number
1259182|NCT00439309|Secondary|Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)|A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow|60 seconds post restoration of blood flow||||percentage of anastomotic sites|Anastomosis||Number
1259183|NCT00439309|Primary|Sealing Success|The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.|Within 10 minutes following restoration of blood flow|The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.|||percentage of participants||95% Confidence Interval|Number
1259184|NCT00439270|Secondary|Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests|ULN=upper limit of normal. Graded by Common Toxicity Criteria: 1 (least severe) to 4 (life threatening ). Absolute neutrophil count (*10^9/L), Grade 3, <1.0-0.5; Grade 4, <0.5. Hemoglobin (mmol/L), Grade 3, <4.9-4.0; Grade 4, <4.0. Platelets (*10^9/L), Grade 3, <50.0-25.0; Grade 4, <25.0. Leukocytes (*10^9/L) Grade 3, <2.0-1.0; Grade 4, <1.0. ALP, ALT, and AST (*ULN), Grade 3, >5.0-20.0; Grade 4, >20.0. Total bilirubin (*ULN), Grade 3, >3.0-10.0; Grade 4, >10.0. Creatinine (*ULN), Grade 3, >3.0-6.0; Grade 4, >6.0. Hypercalcemia (mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. Prothrombin time (seconds), Grade 3, >2.0; Grade 4, not defined.|From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months)|All participants who received at least 1 dose of study drug|||Participants|||Number
1259185|NCT00439270|Secondary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel||Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose|All patients who received at least 1 dose of dasatinib|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1259186|NCT00439270|Secondary|Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel||Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose|All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1259187|NCT00439270|Secondary|Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel||Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose|All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1259188|NCT00439270|Secondary|Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.|From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Participants|||Number
1259208|NCT00439218|Secondary|Pharmacokinetic Parameters (Time to Maximum Plasma Concentration)|Time to maximum plasma concentration (Tmax)|12 weeks|The study was closed prematurely due to slow accrual. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||Hours||Standard Deviation|Mean
1259189|NCT00439270|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.|From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)|All participants who received at least 1 dose of dasatinib|||Participants|||Number
1259190|NCT00439270|Secondary|Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6|The BPI-sf assessed intensity of pain in the last 24 hours as well as impact of pain on daily functions. Patients rated the severity of their pain at its worst, least, and average in the last 24 hours using an 11-point rating scale with endpoints of no pain (0 points) and pain as bad as you can imagine (11 points). They were asked to rate their present pain and pain at the time they completed the BPI-sf. Using an 11-point rating scale with endpoints of does not interfere (0 points) and completely interferes (11 points), the BPI-sf similarly assessed to what extent pain interfered with mood, walking, general activity, work, relations with others, sleep, and enjoyment of life. The BPI-sf also asked patients to mark the location of their pain on a body drawing and included other questions about pain treatment and the extent of pain relief. The BPI-sf was collected in the Phase 2 portion of the study only. For on-treatment visits, the BPI-sf was completed prior to the docetaxel infusion.|At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2, in the Phase 2 portion of the study and completed the BPI-sf at baseline. n=evaluable participants in that cycle.|||Units on a scale||Full Range|Median
1259191|NCT00439270|Secondary|Percentage of Participants With Improvement on Bone Scan|Improvement=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized|From Day 1 of therapy to last bone scan assessment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Percentage of participants||95% Confidence Interval|Number
1259192|NCT00439270|Secondary|Number of Participants by Best On-study Bone Scan Assessment From Baseline|Stable=no new lesions appeared at any 6-week assessment or new pain was not developed in an area that was previously visualized for a minimum of 18 weeks; no change=stable disease prior to 18 weeks and then discontinued treatment; progression=2 or more new areas of focal uptake or new adverse clinical symptoms in an area previously visualized; improved=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized.|From Day 1 of therapy to last bone scan assessment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Participants|||Number
1259193|NCT00439270|Primary|Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2|Because no dose-limiting toxicities occurred, the recommended dose of dasatinib used in Phase 2 was based on findings from ongoing studies in chronic myelogenous leukemia and experience from the previous Phase 2 study of single-agent dasatinib in chronic refractory prostate cancer. The recommended Phase 2 dose of docetaxel (75 mg/m^2) was based on the docetaxel package insert.|From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)|All patients who received at least 1 dose of dasatinib in Phase 1|||mg|||Number
1259194|NCT00439270|Secondary|Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor sufficient shrinkage to qualify for PR.~PD=a 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline; unequivocal progression of nonmeasurable disease/lesions as evaluated by CT scan or MRI (not as evaluated by radionuclide bone scan) and/or new lesions are present.~To qualify as SD, patients had to exhibit SD for a minimum of 18 weeks. Those with evaluations noted as SD prior to 18 weeks and discontinued were reported as no change."|Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Participants|||Number
1259195|NCT00439270|Secondary|Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate is defined as the percentage of participants who have achieved best responses of confirmed Complete Response (CR) or Partial Response (PR) where confirmed requires repeat evaluations for a minimum of 4 weeks after the criteria for response are first met. RECIST: CR=disappearance of clinical and radiologic evidence of target lesions; PR=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD.|Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Percentage of participants||95% Confidence Interval|Number
1259196|NCT00439270|Secondary|Number of Months of Progression-free Survival (PFS)|"PFS defined as time in months from the first dosing date to the date of disease progression or the date of death. Patients who neither progressed nor died were censored on the date of their last on-study prostate specific antigen (PSA) measurement, tumor assessment, or radionuclide bone scan assessment (whichever occurred last). Disease progression defined as either of the following: progression on radionuclide bone scan, death, or at least 2 of the following:~tumor progression, as defined by modified Response Evaluation Criteria in Solid Tumors; PSA progression; or investigator-defined clinical progression based on physical examination, history, symptoms, and performance status."|Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Months||95% Confidence Interval|Median
1259197|NCT00439270|Secondary|Duration of Prostate Specific Antigen (PSA) Response|Duration of response is computed for participants with confirmed PSA response. It is measured in months from the time of the first of 2 consecutive measurements meeting the criteria for confirmed PSA response to the date of the first of 3 consecutive measurements that confirm PSA progression, the date of disease progression, or the date of death. Participants who neither progressed (PSA or disease) nor died were censored on the date of their last PSA assessment. PSA response is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements. PSA progression is defined as 3 consecutive increases in PSA from baseline or nadir, each measurement at least 1 week apart. The final confirming PSA measurement had to be ≥5ng/mL higher than baseline or nadir and also represent at least a 50% increase from baseline or nadir (ie, the value is ≥1.5*baseline or nadir PSA).|At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment|All participants who received dasatinib, 100 mg + docetaxel, 75 mg/m^2 and who had a PSA response|||Months||95% Confidence Interval|Median
1259198|NCT00439270|Primary|Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel|MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for >14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.|From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)|All patients who received at least 1 dose of dasatinib in Phase 1|||mg|||Number
1259199|NCT00439270|Secondary|Percentage of Participants With a Prostate Specific Antigen (PSA) Response|PSA response rate is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements|At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Percentage of participants||95% Confidence Interval|Number
1259200|NCT00439244|Secondary|Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)|Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum β-CTx was determined by the central laboratory.|At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window|||ng/mL||Standard Deviation|Mean
1259201|NCT00439244|Secondary|Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)|Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum P1NP was determined by the central laboratory.|At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window|||ng/mL||Standard Deviation|Mean
1259202|NCT00439244|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52|BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 13, Week 26 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.|||Percent Change||Standard Error|Least Squares Mean
1259203|NCT00439244|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26|BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 13 and Week 26|The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.|||Percent Change||Standard Error|Least Squares Mean
1259204|NCT00439244|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data.|||Percent change||Standard Error|Least Squares Mean
1259205|NCT00439231|Primary|To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen|To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen|24 weeks of lenalidomide therapy||||participants|||Number
1259206|NCT00439218|Secondary|Overall Study Drug Compliance|Subjects receiveing 80% or more of the prescribed doses within each study visit interval were considered compliant.|12 weeks|A total of 5 participants were enrolled in the study. Four enrolled in Cohort 1.|||Participants|||Number
1259210|NCT00439218|Primary|Survival Motor Neuron (SMN) Protein|The change of level in blood SMN protein from baseline to assess time course and dose response.|Baseline - 12 Weeks|The study was closed prematurely due to slow accrual. These data are exploratory and have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||SMN/beta tubulin||Standard Deviation|Mean
1259211|NCT00439218|Secondary|Drug Safety|Adverse event (AE) monitoring|14 weeks|The study was closed prematurely due to slow accrual. These data have not yet been analyzed. Their interpretability will be limited because of the small number of subjects enrolled. There were no safety concerns reported by the SMC.|||Adverse Events|||Number
1259212|NCT00439218|Primary|Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA)|The change of level in blood SMN mRNA from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to slow accrual. These data are exploratory and have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||Cycle Threshold (Ct)||Standard Error|Mean
1259213|NCT00439218|Primary|Dose Limiting Toxicities (DLT)|Number of DLTs to determine the maximum tolerated dosage. A DLT is defined as any Grade(GR)3 or higher adverse event, GR 1 or higher cardiac arrhythmia; GR 2 or higher vomiting; GR 2 or higher liver dysfunction/failure (clinical); GR 2 elevation of amylase or lipase accompanied by clinical symptoms of pancreatitis. The following GR 2 events are classified as DLTs if evaluated to be clinically significant by the principal investigator or medical safety monitor: decrease of hemoglobin, WBCs, platelets; elevation of AST, ALT, bilirubin; abnormlity of Na, K, Cl, CA, HCO3, glucose, BUN, creatinine.|29 days|The study was closed prematurely due to slow accrual. The MTD could not be determined due to the small number of subjects enrolled.|||DLT(s)|||Number
1259214|NCT00439179|Secondary|Number of Patients Who Experienced a Partial Response|To assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.|every two months until progression||||participants|||Number
1259215|NCT00439179|Primary|Toxicity (Number of Patients Who Experiened DLTs)|To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs|until death, approximately 2 years||||participants|||Number
1259216|NCT00439140|Other Pre-specified|Number of Participants With at Least a 20% Decrease From Baseline in FVC|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.|Baseline, Weeks 2, 6 and 12|Safety population included all randomized participants who received treatment.|||Participants|||Number
1259217|NCT00439140|Other Pre-specified|Number of Participants With at Least a 15% Decrease From Baseline in FVC|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.|Baseline, Weeks 2, 6 and 12|Safety population included all randomized participants who received treatment.|||Participants|||Number
1259218|NCT00439140|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).|Baseline, Week 6|Intent-to-treat population included all randomized participants.|||mL||Standard Deviation|Mean
1259219|NCT00439140|Secondary|Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)|MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).|Baseline, Week 6|Intent-to-treat population included all randomized participants.|||cm H2O||Standard Deviation|Mean
1259220|NCT00439140|Secondary|Change From Baseline in the Number of Urinary Incontinence Episodes|The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).|Baseline, Week 6|Participants from the Intent-to-treat population (all randomized participants) using observed data for analysis.|||Episodes||Standard Deviation|Mean
1259221|NCT00439140|Primary|Change From Baseline in FEV1/FVC Ratio|The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety population included all randomized participants who received treatment.|||Ratio||Standard Deviation|Mean
1259222|NCT00439140|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety population included all randomized participants who received treatment.|||Liters||Standard Deviation|Mean
1259223|NCT00439140|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety Population included all randomized participants who received treatment.|||Liters||Standard Deviation|Mean
1259224|NCT00438971|Other Pre-specified|Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT is a brief measure of psychosocial functioning in work, interpersonal relations, satisfaction, and recreation. Scores on the LIFE-RIFT can range from 4, indicating very good functioning (no impairment) in all of the 4 component areas, to 20, indicating very poor functioning (severe impairment) in all of the 4 areas.|8 weeks||||units on a scale||Standard Deviation|Mean
1259562|NCT00436345|Secondary|Total Dose of Fentanil Administered - Bolus|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Fentanil were analyzed.|||ug/kg||Standard Deviation|Mean
1259225|NCT00438971|Other Pre-specified|Sheehan Disability Scale (SDS)|The SDS is a 3-item measure with each item rated on a 10-point scale. The SDS measures the extent to which work/school, social life, and home life or family responsibilities are impaired by symptoms. Total scores range from 0 to 30, with higher scores reflecting greater impairment.|8 weeks||||units on a scale||Standard Deviation|Mean
1259226|NCT00438971|Other Pre-specified|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Q-LES-Q is a self-report measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Only the first 14 items are included in scoring, which ranges from 14 to 70, with higher scores reflecting greater enjoyment and satisfaction. The last two items are not included in the total score but are standalone items.|8 weeks||||units on a scale||Standard Deviation|Mean
1259227|NCT00438971|Other Pre-specified|Beck Anxiety Inventory (BAI)|The BAI is a 21-item self-report measure of anxiety with a focus on somatic symptoms. Total scores range from 0 to 63, with higher scores reflecting greater symptom severity.|8 weeks||||units on a scale||Standard Deviation|Mean
1259228|NCT00438971|Other Pre-specified|Montgomery Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item clinician rating of depressive symptoms. Scores range from 0 to 60, with higher scores reflecting greater symptom severity.|8 weeks||||units on a scale||Standard Deviation|Mean
1259229|NCT00438971|Secondary|Panic Attack Scale (PAS)|The PAS is a measure that assesses participants' total number of panic attacks (situational and unexpected with full and limited symptoms), as well as anticipatory anxiety, since last visit. There is no total score.|8 weeks||||units on a scale||Standard Deviation|Mean
1259230|NCT00438971|Secondary|Clinical Global Impression of Severity Scale (CGI-S)|The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Remission was defined strictly as a CGI-S score of 1 or 2 (not at all ill or borderline ill) and zero panic attacks at endpoint.|8 weeks||||units on a scale||Standard Deviation|Mean
1259231|NCT00438971|Primary|Panic Disorder Severity Scale (PDSS)|The PDSS contains seven items assessing multiple dimensions of panic disorder severity, including (a) frequency of panic attacks, (b) distress during panic attacks, (c) anticipatory anxiety, (d) agoraphobic fear and avoidance, (e) interoceptive fear and avoidance, (f) impairment of work functioning, and (g) impairment of social functioning. The PDSS ranges from 0 to 28, with higher ratings reflecting greater degrees of symptom severity.|8 weeks||||units on a scale||Standard Deviation|Mean
1259232|NCT00438932|Secondary|24-hour Urinary Phosphate|from 24-hr urine collections|2 weeks||||mg||Standard Error|Mean
1259233|NCT00438932|Primary|Fibroblast Growth Factor 23 (FGF-23)|Plasma FGF-23 was measured using c-terminal FGF23 assay.|2 weeks||||RU/ml||Standard Error|Mean
1259234|NCT00438880|Secondary|Duration of Response|Duration of response (DoR) will be calculated from the documentation of response until the date of progression in the subset of patients who respond.|Up to 1 year from treatment start date|The duration of response was not analyzed due to a lack of more than one response.||||||
1259235|NCT00438880|Secondary|Progression-free Survival|The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.|Up to 1 year from treatment start date|Only participants accrued to the Phase II portion of the study were evaluated for this endpoint.|||months||95% Confidence Interval|Median
1259236|NCT00438880|Primary|Tumor Response|"Complete Response (CR):~No measurable or nonmeasurable disease.~No symptoms of Lymphoma.~Non-palpable spleen, if palpable at baseline.~Histologically negative bone marrow, if positive at baseline.~All nodes <1.5 cm in transverse diameter.~Partial Response (PR):~greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions.~No new lesions~We are reporting the number of participants that attained a status of CR or PR."|Evaluations occur every three months up to a year|Participants accrued to the Phase I portion of this study were not used to analyze the Phase II primary endpoint.|||participants|||Number
1259237|NCT00438880|Primary|Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level|"Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following:~Absolute neutrophil counts or platelet counts below 10*10^9/L for 14 days~Absolute neutrophil counts greater than 0.5 or less than 1*10^9/L~Platelet counts greater than 10 or less than 50*10^9/L for 28 days.~Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.~We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity."|at least 10 weeks post treatment up to 3 months.|Only participants accrued to the Phase I portion of this study were used to determine the maximum tolerated dose.|||participants|||Number
1259238|NCT00438854|Secondary|Median Overall Survival|The median survival time, as measured from the start of treatment until death from any cause.|3 years||||Months||Full Range|Median
1259239|NCT00438854|Secondary|Median Time to Disease Progression|The median time to disease progression, measured from the start of treatment.|1 year||||Months||Full Range|Median
1259240|NCT00438854|Secondary|Complete Response Rate|The number of participants with a 100% reduction in nodal mass.|1 year||||Participants|||Count of Participants
1259241|NCT00438854|Primary|Overall Objective Response|"Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria):~Complete response (CR) requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy~No hepatomegaly or splenomegaly~Absence of constitutional symptoms~Normal complete blood count~Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease~Partial response (PR): requires at least the following:~50% decrease in peripheral blood lymphocyte count~50% reduction in lymphadenopathy~50% reduction in the size of the liver and/or spleen"|2 years||||participants who responded|||Number
1259242|NCT00438815|Primary|Percent of HAE Attacks With Substantial Relief of the Defining Symptom|Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. The conservative analysis defined substantial relief as 3 consecutive assessments of improvement of the defining symptom; any attack that did not have 3 consecutive documented reports of improvement was considered a treatment failure. In the less conservative analysis, attacks also were considered to have responded if clinical improvement of the defining symptom occurred but data were incomplete due to cessation of symptom assessments.|Within 4 hours after initial treatment|ITT-E Population (N=101; the number of subjects who received at least one dose of C1INH-nf for the treatment of an acute HAE attack).|||percent of attacks|||Number
1259243|NCT00438815|Secondary|Complement C4 Serum Levels|Change in complement C4 serum levels from pre-infusion to 1 hour after the initial dose of study drug.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=74).|||mg/dL||Standard Deviation|Mean
1259244|NCT00438815|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1 hour after the initial dose of study drug.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=82).|||percent of functional C1INH||Standard Deviation|Mean
1259245|NCT00438815|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1 hour after the initial dose of study drug.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=84).|||mg/dL||Standard Deviation|Mean
1259246|NCT00438815|Secondary|Time to Beginning of Substantial Relief of the Defining Symptom for Subjects Who Received Multiple Treatments|For attack number 1, the number of censored observations precluded estimation of the 95% confidence interval (CI) upper bound for median time to event (subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations). Entry of 4.0 hours indicates that data were not estimable (NE); as non-numeric data are not supported by the 95% CI field, entry of the actual result (ie, NE or >4.0) was not possible.|Within 4 hours after initial treatment|ITT-E subjects with at least 10 HAE attacks during the study (N=15).|||hours||95% Confidence Interval|Median
1259247|NCT00438815|Secondary|Time to Beginning of Substantial Relief of the Defining Symptom|Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|ITT-E Population.|||hours||95% Confidence Interval|Median
1259248|NCT00438815|Primary|Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf||Duration of the study (2.5 years)|Intent-to-treat Efficacy (ITT-E) Population (N=101; the number of subjects who received at least one dose of C1INH-nf for the treatment of an acute HAE attack).|||attacks|||Number
1259249|NCT00438802|Primary|Maximum Tolerated Dose (MTD)|The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on DLT toxicities encountered during the first 8 weeks of treatment reported in Primary Outcome Measure #1.|8 weeks from registration|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.|||mg/kg Alefacept|||Number
1259250|NCT00438802|Secondary|Clinical Response|"Treatment response and evaluation will be performed using standardized lymphoma International Working Group recommendations. >~> A Complete Response (CR) requires: >~Complete disappearance of all detectable clinical and radiographic evidence of > disease. >~All lymph nodes and nodal masses must have regressed to normal size. >~Partial Response (PR): >~greater than 50% decrease in Sum of Product Dimensions of the six largest dominant nodes, nodal masses, or skin lesions. >~No increase in size of other nodes >~no new sites of disease."|up to 12 cycles (28 days per cycle) of treatment.|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.|||participants|||Number
1259251|NCT00438802|Primary|Dose Limiting Toxicity (DLT)|"The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on toxicities encountered during the first 8 weeks of treatment. >~> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: >~grade 4 toxicity for neutrophils (<0.5 x 109/L) or platelets (<25 x 109/L) >~any grade 3 or higher solid organ toxicity not explainable by another obvious cause. >~more than 10 x ULN AST toxicity for more than 14 days >~any grade 4 infection. >~The number of patients who reported a dose limiting toxicity is reported here."|8 weeks from registration|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.|||Participants|||Count of Participants
1259252|NCT00438750|Secondary|Grip Strength|Measured with use of a grip meter as the average of three attempts.|6 months||||Pounds (lbs)||Standard Deviation|Mean
1259253|NCT00438750|Secondary|Mayo Wrist Score|A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.|6 months||||units on a scale||Standard Deviation|Mean
1259254|NCT00438750|Secondary|Gartland and Werley Score|An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.|6 months||||units on a scale||Standard Deviation|Mean
1259255|NCT00438750|Secondary|Pinch Strength|"Pinch strength measured with the B&L pinch gauge.~B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym)."|6 months||||Pounds (lbs)||Standard Deviation|Mean
1259256|NCT00438750|Secondary|10-point Ordinal Pain Scale|A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.|6 months||||units on a scale||Standard Deviation|Mean
1259618|NCT00435994|Primary|Endothelial Growth Factor (VEGF)|Analysis for VEGF level by ELISA|During nasal wash|Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV.|||pg/dl||Standard Deviation|Mean
1259257|NCT00438750|Secondary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|"The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.~Mean and standard deviations are identical for both arms."|6 months||||units on a scale||Standard Deviation|Mean
1259258|NCT00438750|Primary|Range of Motion in Degrees of the Wrists|"Mean arc of wrist flexion and extension six months after surgery.~Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees."|6 months||||Degrees||Standard Deviation|Mean
1259259|NCT00438672|Primary|Visual Analog Scale for Pain|Pain is measured on a 10 cm long line that starts at 0 on the left and ends with 10 on the right. A score of 0 represents no pain at all, and a score of 10 represents the worst pain ever. The individual score is measured using a measuring rod, measuring the distance from the left border in centimeters.|6 months||||units on a scale||Standard Deviation|Mean
1259260|NCT00438672|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.|6 months||||units on a scale||Standard Deviation|Mean
1259261|NCT00438659|Secondary|Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).|Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)|During Radiation Treatment, up to a maximum of 11 weeks.||||units on a scale||Standard Deviation|Mean
1259262|NCT00438659|Secondary|Adverse Events Assessed Clinically by NCI CTCAE v3.0||During Radiation Treatment, up to a maximum of 9 weeks.||||participants|||Number
1259263|NCT00438659|Secondary|QOL Domains as Measured by LASA|Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.|During Radiation Treatment, up to a maximum of 11 weeks.|Patients who completed at least 1 assessment were evaluable for this secondary end point.|||units on a scale||Standard Deviation|Mean
1259264|NCT00438659|Secondary|Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)|Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).|During Radiation Treatment, up to a maximum of 11 weeks.|Patients who completed at least 1 assessment were evaluable for this secondary end point.|||units on a scale||Standard Deviation|Mean
1259265|NCT00438659|Secondary|Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.|To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.|During Radiation Treatment, up to a maximum of 9 weeks.|This analysis was not completed due to too little incidence of the dermatitis.||||||
1259266|NCT00438659|Secondary|Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).|Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).|During Radiation Treatment, up to a maximum of 11 weeks.||||score on a 0-6 scale||Standard Deviation|Mean
1259267|NCT00438659|Secondary|Skin Toxicity as Measured by the Skin Toxicity Assessment Tool|Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.|During Radiation Treatment, up to a maximum of 9 weeks.||||Score on a 0 to 5 scale||Standard Deviation|Mean
1259268|NCT00438659|Secondary|Incidence of Severe ( Grade >=3) Radiation Dermatitis|To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.|During Radiation Treatment, up to a maximum of 9 weeks.||||Paticipants|||Number
1259269|NCT00438659|Primary|Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.|Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).|During Radiation Treatment, up to a maximum of 9 weeks.||||Grade||Full Range|Mean
1259270|NCT00438490|Secondary|Estradiol||7 days||||pmol/L||Standard Error|Mean
1259271|NCT00438490|Secondary|Menstrual Cycle Length||28 days||||Days||Standard Error|Mean
1259272|NCT00438490|Secondary|N-telopeptide||7 days||||nM/mM||Standard Error|Mean
1259273|NCT00438490|Primary|Galactorrhea|Galactorrhea is breast milk production.|7 days||||percentage of participants|||Number
1259274|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period.|Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Full Range|Median
1259275|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Full Range|Median
1259276|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Standard Deviation|Mean
1259277|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period|Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Standard Deviation|Mean
1259278|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy|Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Standard Deviation|Mean
1259279|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy|Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Standard Deviation|Mean
1259280|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy|Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Full Range|Median
1259281|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy|Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage tumor cell involvement||Full Range|Median
1259282|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
1259283|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
1259284|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
1259285|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
1259286|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)|Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
1259287|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)|Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||cubic centimeter||Full Range|Median
1259288|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy|Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||participants|||Number
1259289|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus|Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
1259290|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)|Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
1259291|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci|Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
1259292|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status|Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
1259293|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)|Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
1259294|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage|American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles.|Assessment following maximum 6 week treatment period and prostatectomy|All evaluable participants.|||participants|||Number
1259295|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)|Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.|||participants|||Number
1259296|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)|Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.|||participants|||Number
1259297|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score|Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.|||participants|||Number
1259298|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)|"Evaluation of Changes~Changes in the EpiTrack® Score were categorized as follows:~≥5 score points: Improved;~-3 to 4 score points: Unchanged;~≤-4 score points: Worsened"|week 58|Patients of ITT population with data at V6 and V0|||participants|||Number
1259299|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6|"Evaluation of current testing at V6:~≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;~≤25 score points: Impaired"|58 weeks|Patients of ITT population with data at V6|||participants|||Number
1259300|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6|EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45.|week 58|Patients of ITT population who had data at V6|||units on a scale||Standard Deviation|Mean
1259301|NCT00438451|Secondary|Portland Neurotoxicity Scale (PNS) at V6|"The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.~Lower values indicate better quality of life."|at week 58|Patients of ITT population who filled out PNS at V6|||units on a scale||Standard Deviation|Mean
1259302|NCT00438451|Secondary|QOLIE-31 (Quality Of Life In Epilepsy) Results at V6|The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry*0.08 + overall quality of life*0.14 + emotional well-being*0.15 + energy/fatigue*0.12 + cognitive functioning*0.27 + medication effects*0.03 + social functioning*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100.|58 weeks, final visit|Patients of ITT population who filled out QOLIE-31 at V6|||units on a scale||Standard Deviation|Mean
1259303|NCT00438451|Secondary|Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase||52 weeks|Patients of ITT population who reached the maintenance phase|||proportion of seizure-free days|||Number
1259304|NCT00438451|Secondary|The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)|"Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.~The absolute seizure frequency during the maintenance phase was defined as the sum of those entries."|over 52 weeks|"Completer population:~The completer population comprises all patients still being in the study at week 58 (This definition deviates minimally from the protocol. It could not be assessed from the CRF data, if patients were on treatment)."|||number of seizures|||Number
1259305|NCT00438451|Secondary|The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)||over the whole duration of 58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||days||95% Confidence Interval|Median
1259306|NCT00438451|Secondary|Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)|Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58.|week 58|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||percentage of participants|||Number
1259307|NCT00438451|Secondary|Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)|Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30.|Week 30|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||percentage of participants|||Number
1259308|NCT00438451|Secondary|Time to Drop Out|number of days between randomization and premature discontinuation of the study|58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||days||95% Confidence Interval|Median
1259309|NCT00438451|Primary|58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment||58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||proportion of participants||95% Confidence Interval|Mean
1259310|NCT00438399|Primary|Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator|"Subjects’ Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: C. propionate shampoo a lot better than the comparator,C. propionate shampoo a lillte bit better than the comparator, Comparator a lot better than C. propionate shampoo, Comparator a lillte bit better than C. propionate shampoo. This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population."|End of period II (up to 16 weeks)|Intent to Treat population (ITT).|||Percentage of participants|||Number
1259311|NCT00438360|Secondary|Safety / Tolerability Assessed by Adverse Events||24weeks|||||||
1259312|NCT00438360|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus|Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).|Baseline and week 24|Intent to treat (ITT) population. Patients with a value of VAS at baseline and 24 weeks were included in this analysis.|||Units on a scale||Standard Deviation|Mean
1259313|NCT00438360|Secondary|Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( [Height(in) x Weight(lbs) ]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed|Baseline and week 24|Intent to Treat (ITT) population. Patients with a value of BSA at baseline and 24 weeks were included in this analysis.|||BSA (m^2)||Standard Deviation|Mean
1259314|NCT00438360|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree.|baseline and week 24|Intention to treat (ITT) population. Patients with a value of PASI at baseline and 24 weeks were included in this analysis.|||Units on a scale||Standard Deviation|Mean
1259315|NCT00438360|Secondary|Proportion of Participants With Clinical Relapse|Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) >75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment.|24 weeks|Intent to treat population.|||proportion of participants|||Number
1259316|NCT00438360|Primary|Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score|PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score >75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was >= 75%. In all the other cases the patient was considered as success (no relapse).|24 weeks|Intent to treat population.|||Participants|||Number
1259317|NCT00438204|Secondary|Overall Survival|Overall survival using the Kaplan-Meier method.|Every 8 weeks, for up to 54 months||||months||95% Confidence Interval|Median
1259318|NCT00438204|Secondary|Time to Treatment Failure|Time to treatment failure using the Kaplan-Meier method.|Every 8 weeks, for up to 54 months||||months||95% Confidence Interval|Median
1259319|NCT00438204|Secondary|Toxicity|Grade 3/4 toxicity according to the NCI Common Toxicity Criteria v3.0 .|Every two weeks, for up to 54 months||||Participants|||Count of Participants
1259320|NCT00438204|Secondary|Response Rate|The rate of response using RECIST criteria.|Every 8 weeks, for up to 54 months||||Participants|||Count of Participants
1259321|NCT00438204|Primary|Progression-free Survival (PFS)|RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|Up to 12 months||||months||90% Confidence Interval|Median
1259322|NCT00438191|Secondary|Pain Intensity|Pain intensity was measured using the Numeric Rating Scale, on a scale from 0-10, where 0 is no pain and 10 is the most pain.|8 weeks||||units on a scale||Standard Deviation|Mean
1259323|NCT00438191|Secondary|Treatment Satisfaction|Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction|8 weeks||||units on a scale||Standard Deviation|Mean
1259324|NCT00438191|Secondary|Grip Strength|Grip strength is measured as a percentage of the non-affected or least affected side.|8 weeks||||percentage of non-affected hand||Standard Deviation|Mean
1259325|NCT00438191|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.|8 weeks||||units on a scale||Standard Deviation|Mean
1259326|NCT00438100|Secondary|Survival Rate||The follow up period will be two years after the last dose has been administered.|||||||
1259327|NCT00438100|Secondary|Time to Treatment Failure||The follow up period will be two years after the last dose has been administered.|||||||
1259328|NCT00438100|Secondary|Antitumor Effects||The follow up period will be two years after the last dose has been administered.|||||||
1259329|NCT00438100|Secondary|Adverse Events||The follow up period will be two years after the last dose has been administered.|||||||
1259330|NCT00438100|Primary|Progression Free Survival||The follow up period will be two years after the last dose has been administered.||||years||95% Confidence Interval|Median
1259331|NCT00437983|Secondary|Change From Baseline in Rey Osterrieth Complex Figure Test|A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory. Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis. Accuracy range score is 0-36 points (0 is worse, 36 is best). Copy time is expressed in seconds (less time to copy indicates better performance).|baseline, 15 weeks|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).|||Units on a scale||Standard Error|Mean
1259332|NCT00437983|Secondary|Clinical Global Impression of Change (CGI-C)Scale|The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician’s global impression of change. Global improvement score ranges from 1 = “Very much improved”, through 4 = “No change”, to 7 = “Very much worse”. Participants who experienced an improvement (scores 1, 2 or 3) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)|7 weeks, 15 weeks|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).|||Participants who experienced improvement|||Number
1259333|NCT00437983|Secondary|Computerized Cognitive Assessment Tool||baseline, 15 weeks|||||||
1259334|NCT00437983|Secondary|Trail Making Test||Baseline, 15 weeks|||||||
1259335|NCT00437983|Secondary|Blood Work||baseline,15 wk|||||||
1259336|NCT00437983|Primary|Change From Baseline in Rey Auditory Verbal Learning Test|A widely used, brief, easy to understand scale to evaluate verbal learning and memory. The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).|baseline, 15 wk|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn’t meet the compliance criteria (≥ 65%).|||number of words correctly recalled||Standard Error|Mean
1259337|NCT00437658|Secondary|Percentage of Participants Using Analgesics During the Treatment Phase|Analgesic use was collected as part of concomitant medications on a case report form that was administered at each scheduled visit.|24 weeks|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat).|||percentage of participants|||Number
1259338|NCT00437658|Secondary|Change From Baseline in EHP-5 Treatment Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259339|NCT00437658|Secondary|Change From Baseline in EHP-5 Medical Profession Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259340|NCT00437658|Secondary|Change From Baseline in EHP-5 Intercourse Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259701|NCT00435162|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)||baseline and week 6|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1259341|NCT00437658|Secondary|Change From Baseline in EHP-5 Relationship With Children Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259342|NCT00437658|Secondary|Change From Baseline in EHP-5 Work Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259343|NCT00437658|Secondary|Change From Baseline in EHP-5 Self Image Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259344|NCT00437658|Secondary|Change From Baseline in EHP-5 Social Support Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259345|NCT00437658|Secondary|Change From Baseline in EHP-5 Emotional Well-being Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259346|NCT00437658|Secondary|Change From Baseline in EHP-5 Control and Powerlessness Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259347|NCT00437658|Secondary|Change From Baseline in Endometriosis Health Profile–5 (EHP-5) Pain Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1259348|NCT00437658|Secondary|Change From Baseline in in Monthly Mean Visual Analog Scale (VAS) for Pelvic Pain|"The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled “no pain” and the right extreme was labeled “worst pain ever felt” scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ‘‘ticking’’ the horizontal line on their e-Diary at approximately the same time each day. Monthly mean VAS for pelvic pain defined as the average of all VAS pain scores reported for an individual participant from the previous visit to the day of the current scheduled visit.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259349|NCT00437658|Secondary|Change From Baseline in in Monthly Peak Visual Analog Scale (VAS) for Pelvic Pain|"The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled “no pain” and the right extreme was labeled “worst pain ever felt” scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ‘‘ticking’’ the horizontal line on their e-Diary at approximately the same time each day. Monthly peak VAS for pelvic pain was defined as the maximum VAS pain score reported for an individual participant from the previous visit to the day of the current scheduled visit.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259350|NCT00437658|Secondary|Change From Baseline in Pelvic Induration Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Pelvic induration was assessed by the investigator based on findings associated with a pelvic examination.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259351|NCT00437658|Secondary|Change From Baseline in Pelvic Tenderness Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Pelvic tenderness was assessed by the investigator based on findings associated with a pelvic examination.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259358|NCT00437658|Secondary|Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?.~Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline."|Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||percentage of participants|||Number
1259352|NCT00437658|Secondary|Change From Baseline in Non-menstrual Pelvic Pain Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The non-menstrual pelvic pain score was based on participant's response to the question Have you had pelvic pain during the last 28 days?.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259353|NCT00437658|Secondary|Change From Baseline in Dyspareunia Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The dyspareunia score was based on the participant's response to the question “Have you had painful intercourse during the last 28 days?” Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259354|NCT00437658|Secondary|Change From Baseline in Dysmenorrhea Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259355|NCT00437658|Secondary|Change From Baseline in Total CPSSS Excluding Dyspareunia During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.~The total CPSSS excluding dyspareunia has a maximum possible value of 12 (total score range: 0 to 12, where a lower score indicates less signs and symptoms of endometriosis or better functioning).~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259356|NCT00437658|Secondary|Change From Baseline in Total CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.~The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning).~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1259357|NCT00437658|Secondary|Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question Have you had pelvic pain during the last 28 days? Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline."|Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||percentage of participants|||Number
1259359|NCT00437658|Secondary|Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24|The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question “Have you had pelvic pain during the last 28 days?” Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline.|Baseline and week 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary visual analog scale (VAS) values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data.|||percentage of participants|||Number
1259360|NCT00437658|Secondary|Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24|"The CPSSS consists of 5 components that address dysmenorrhea (pain during menstruation), dyspareunia (painful intercourse), non-menstrual pelvic pain, pelvic tenderness, and pelvic induration (hardening). Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?”.~Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline."|Baseline and week 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary visual analog scale (VAS) values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data.|||percentage of participants|||Number
1259361|NCT00437658|Secondary|Change From Baseline in N-telopeptide at Weeks 12, 24 and 48|Blood samples to determine N-telopeptide concentrations were analyzed by a central laboratory using an enzyme-linked immunosorbent assay (ELISA). Change from baseline in N-telopeptide was analyzed using a one-way ANOVA model.|Baseline and weeks 12, 24 and 48|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point|||nM bone collagen equivalents (BCE)||Standard Error|Least Squares Mean
1259362|NCT00437658|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48|Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model.|Baseline and weeks 12 and 48|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point|||percent change||95% Confidence Interval|Least Squares Mean
1259363|NCT00437658|Secondary|Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48|Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model.|Baseline and weeks 12 and 48|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point|||percent change||95% Confidence Interval|Least Squares Mean
1259364|NCT00437658|Primary|Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24|Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.|Baseline and week 24|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at both time points|||percent change||95% Confidence Interval|Least Squares Mean
1259365|NCT00437658|Primary|Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24|Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.|Baseline and week 24|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at both time points|||percent change||95% Confidence Interval|Least Squares Mean
1259366|NCT00437645|Secondary|Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12|Systolic response was defined as msSBP < 130 mmHg or at least a 20 mmHg reduction from baseline in msSBP at Weeks 4, 8, and 12. Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|Baseline to Weeks 4, 8, and 12|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).|||Percentage of patients|||Number
1259367|NCT00437645|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Weeks 4, 8, and 12|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).|||mmHg||Standard Error|Least Squares Mean
1259368|NCT00437645|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).|||mmHg||Standard Error|Least Squares Mean
1259369|NCT00437645|Primary|Percentage of Patients With Peripheral Edema From Baseline to Week 8|Only occurrences of peripheral edema quantified as a reported adverse event coded as peripheral edema were included in the analysis. If a patient experienced more than one occurrence of peripheral edema between Day 1 and Week 8, it was only counted once in the analysis.|Baseline to Week 8|Safety population: All randomized patients.|||Percentage of patients|||Number
1259370|NCT00437645|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).|||mmHg||Standard Error|Least Squares Mean
1259371|NCT00437489|Secondary|Hypoglycemia Event Rate Per Month|Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).|up to week 4 or 16|FAS Population|||event rate per month||Standard Deviation|Mean
1259372|NCT00437489|Secondary|Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia|Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.|week 16|FAS Population - Descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.|||participants|||Number
1259373|NCT00437489|Primary|Change in HbA1c From Baseline|Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16|From baseline to week 16|Full analysis set (FAS) population - descriptive statistics were produced using last observation carried forward (LOCF) for Week 16, therefore all subjects are included in the Week 16 data.|||Percent||Standard Deviation|Mean
1259374|NCT00437489|Secondary|Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)|Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.|From baseline to week 16|FAS - descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.|||mmol/l||Standard Deviation|Mean
1259375|NCT00437398|Secondary|Mean Glycated Hemoglobin (HbA1c) Since Transplant|HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well the subject is controlling his/her diabetes.|3, 6, 9, and 12 months since islet transplantation|The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.||||||
1259376|NCT00437398|Primary|Mean Number of Hypoglycemic Events After Transplant|Hypoglycemia is an abnormally diminished content of glucose in the blood.|3, 6, 9, and 12 months since islet transplantation|The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.||||||
1259377|NCT00437281|Primary|Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment|Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.|Day 8 up to 28 days after open-label dose of study medication|Safety analysis set included all participants who received at least 1 dose of study medication.|||adverse events|||Number
1259378|NCT00437281|Secondary|Renal Clearance (CLr): Single-Dose Analysis|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants).|0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are only reported for pregabalin 15 mg/kg/day, 7 to 11 years and pregabalin 5 mg/kg/day, 12 to 16 years because none of the participant had PK parameter available in rest of the groups.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1259549|NCT00436436|Secondary|Toxicity as Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v 3)|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. Adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE)v3.|18 months and 4 days||||Participants|||Count of Participants
1259379|NCT00437281|Secondary|Renal Clearance (CLr): Multiple-Dose Analysis|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for some of the groups since none of the participant had PK parameter available in these groups.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1259380|NCT00437281|Secondary|Apparent Oral Clearance (CL/F): Single-Dose Analysis|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1259381|NCT00437281|Secondary|Apparent Oral Clearance (CL/F): Multiple-Dose Analysis|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1259382|NCT00437281|Secondary|Plasma Decay Half-Life (t1/2): Single-Dose Analysis|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||hours||Standard Deviation|Mean
1259383|NCT00437281|Secondary|Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
1259384|NCT00437281|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis|Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||hours||Full Range|Median
1259385|NCT00437281|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis|Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Full Range|Median
1259386|NCT00437281|Secondary|Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis|Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||(microgram/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
1259387|NCT00437281|Secondary|Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis|Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(microgram/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
1259400|NCT00437203|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng/mL||Standard Deviation|Geometric Mean
1259762|NCT00434876|Secondary|Insomnia Severity Index (ISI)|ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity.|Baseline, weeks 1, 3, 5, and 7 of treatment.||||units on a scale||Standard Deviation|Mean
1259388|NCT00437281|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||(microgram*hour/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
1259389|NCT00437281|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis|Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(microgram*hour/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
1259390|NCT00437281|Secondary|28-Day Seizure Frequency Rate|Seizure frequency was reported by participant's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period)*28.|Baseline up to 7 days post-last dose of study medication|Results are not reported since the data was reported in individual participant listings but not summarized for analysis.||||||
1259391|NCT00437281|Primary|Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment|Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.|Baseline to Day 7|Safety analysis set included all participants who received at least 1 dose of study medication.|||adverse events|||Number
1259392|NCT00437281|Secondary|Number of Participants With Clinically Significant Change in Physical and Neurological Findings|Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator.|Baseline up to 7 days post-last dose of study medication|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1259393|NCT00437203|Secondary|Metabolite Profile of PF-00477736 in Plasma and Urine||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||percentage of recovered metabolite|||Number
1259394|NCT00437203|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||hr||Standard Deviation|Mean
1259395|NCT00437203|Secondary|Concentration of PF-00477736 in Urine||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng/mL||Standard Deviation|Geometric Mean
1259396|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng*hr/mL||Standard Deviation|Geometric Mean
1259397|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]|AUC (0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).|0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng*hr/mL||Standard Deviation|Geometric Mean
1259398|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0|Data was not analyzed, as study was terminated due to business reasons.|||ng*hr/mL||Standard Deviation|Geometric Mean
1259399|NCT00437203|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||hr||Full Range|Median
1293197|NCT00100698|Secondary|Change in Carotid Intima Media Thickness (IMT)|change in carotid intima media thickness (IMT)|18 months||||millimeter||Standard Error|Mean
1259401|NCT00437203|Secondary|Maximum Observed Plasma Concentration (Cmax)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng/mL||Standard Deviation|Geometric Mean
1259402|NCT00437203|Secondary|Number of Participants With Objective Response (OR)|OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.|Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62|FAS included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1259403|NCT00437203|Primary|Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine||Up to Day 21 Cycle 1|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study medication.|||mg|||Number
1259404|NCT00437125|Secondary|Number of Participants Who Reached Remission by 12 Weeks|Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score <=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.|||participants|||Number
1259405|NCT00437125|Secondary|Number of Participants Who Responded to Treatment by 12 Weeks|Response was defined as a >= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.|||participants|||Number
1259406|NCT00437125|Secondary|Laboratory Analytes|Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.|baseline through 12 weeks|All enrolled participants for whom both baseline data and post-baseline data were available were included in the analyses.|||participants|||Number
1259407|NCT00437125|Secondary|Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study|Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.|baseline through 12 weeks|All treated participants were included in the analysis population. 54 participants were excluded from calculation of change as they had abnormal ECG at baseline, no baseline measure, or no post-baseline measure.|||participants|||Number
1259408|NCT00437125|Secondary|Average Change From Baseline to 12 Weeks in Heart Rate|For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.|baseline through 12 weeks|All treated participants were included in the analysis population. 6 participants were excluded from calculation of change as they had either no baseline or post-baseline measure.|||beats per minute||95% Confidence Interval|Mean
1259409|NCT00437125|Secondary|Average Change From Baseline to 12 Weeks in Blood Pressure|For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.|baseline through 12 weeks|All treated participants were included in the analysis population. 5 participants for standing measurement and 6 participants for supine measurements were excluded from calculation of change as they had either no baseline or no post-baseline measure.|||millimeter mercury||95% Confidence Interval|Mean
1259410|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score|The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale.|baseline, 12 weeks|All treated participants with both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with no baseline measure and 29 participants with no post baseline measure.|||units on a scale||Standard Deviation|Mean
1259411|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93.|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with only post-baseline data and 1 participant with only baseline data.|||units on a scale||Standard Deviation|Mean
1259412|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. 27 participants had no post baseline measure.|||units on a scale||Standard Deviation|Mean
1259413|NCT00437125|Secondary|Patient's Global Impression-Improvement at Week 12|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse.|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses.|||participants|||Number
1259414|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.|||units on a scale||Standard Deviation|Mean
1259415|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.|||units on a scale||Standard Deviation|Mean
1259416|NCT00437125|Secondary|Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)|Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21).|baseline, 4 weeks, 8 weeks, 12 weeks|All treated participants with baseline and post-baseline data for >= 1 visit for >= 1 efficacy variable were included in the analyses (Full Analysis Set population). Last observation carried forward analysis. Excluded 2 participants (no baseline measure of PSQI) and 13 participants from calculation of change (absence of any post-baseline measure).|||units on a scale||Standard Deviation|Mean
1259417|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale|Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment.|baseline, 12 weeks|All treated participants were included in the analysis population. Last observation carried forward analysis. One participant was excluded as no data for UKU were available and other participants were excluded as relevant due to absence of either baseline or post-baseline measure.|||units on a scale||Standard Deviation|Mean
1259418|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability.|baseline, 12 weeks|All treated participants were included in the analysis population. Last observation carried forward analysis. Two participants were excluded from calculation of change as they had no post-baseline measure.|||units on a scale||Standard Deviation|Mean
1259419|NCT00437125|Primary|Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death|The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.|baseline through 12 weeks|All treated participants.|||participants|||Number
1259420|NCT00437073|Secondary|Percentage of Participants With a >=20% Volumetric Reduction in CNS Lesions|The percentage of participants with a >=20% volumetric reduction in CNS lesions was defined as the percentage of treated participants achieving at least a 20% volumetric reduction in CNS lesions relative to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|Baseline; from the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259421|NCT00437073|Secondary|Percentage of Participants With Disease Stabilization for 6 Months or More|The percentage participants with disease stabiliztion for 6 months or more were defined as those treated participants with a best CNS objective response of SD whose disease stabilization lasted 6 months or more from the start of treatment. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259422|NCT00437073|Secondary|Percentage of Participants With Baseline Tumor-related (TR) Neurological Signs and Symptoms (NSS), Who Experienced Improvement in NSS as Measured by the Neurological Examination Worksheet (NEW)|TR NSS was to be recorded by the Investigator on the NEW, using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE V3.0). Improvement was to be defined as a decrease of 1 or more CTCAE grades from baseline of any TR NSS. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259423|NCT00437073|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259424|NCT00437073|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the start of treatment until the first documented sign of disease progression at any site or death due to any cause, if sooner. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259425|NCT00437073|Secondary|Number of Participants With the Indicated Site of Initial Disease Progression|The site of initial disease will be determined by taking the earliest date of known progression and assigning the appropriate category (CNS or non-CNS) based on the source of the earliest date. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259426|NCT00437073|Secondary|Time to CNS Objective Response (Defined as the Time From the Start of Treatment Until the First Documented Evidence of Partial or Complete Tumor Response [Whichever Status is Recorded First])|CNS OR is defined as the number of participants with either a CR or PR as assessed by volumetric analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259427|NCT00437073|Secondary|Percentage of Participants (Par.) With Objective Response by RECIST in Non-CNS Disease|Non-CNS disease (for par. with measurable baseline non-CNS disease) OR is defined as the number of par. with either a CR or PR as assessed by computed tomography (CT) or MRI scan and RECIST. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough par. enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259428|NCT00437073|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit is defined as CR (complete resolution of all evaluable and non-evaluable brain metastases), PR (=>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline), or stable disease (disease that does not meet CR, PR, or CNS progression criteria) for at least 6 months. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259429|NCT00437073|Secondary|Duration of CNS Objective Response (Defined as the Time From the First Documented Evidence of CNS PR or CR Until the First Documented Sign of Disease Progression or Death, if Sooner)|CNS OR is defined as the number of participants with either a CR or PR as assessed by volumetric analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
1259430|NCT00437073|Primary|Number of Participants With the Indicated CNS Responses|"CNS responses were assessed by volumetric (V) analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases (BMs). PR: =>50% reduction in the V sum of all evaluable BMs compared to baseline. A response of Other was used for participants who discontinued the study prior to the first efficacy assessment. Stable Disease (SD): disease that does not meet CR, PR, or CNS progression criteria. Progressive disease (PD): a requirement for a new steroid or an increasing steroid dose for the treatment of worsening neurological signs/symptoms due to BMs."|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||participants|||Number
1259431|NCT00437073|Primary|Number of Participants With the Indicated Central Nervous System (CNS) Objective Response (OR)|CNS OR is defined as the number of participants with either a complete response (CR) or partial response (PR) as assessed by volumetric analysis of brain magnetic resonance imaging (MRI) and Response Evaluation Criteria In Solid Tumors (RECIST). CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|Modified Intent-to-Treat (mITT) Population: all participants who had at least one evaluable CNS target lesion at baseline and who had received at least two doses of lapatinib medication|||participants|||Number
1259432|NCT00437034|Secondary|Circulating Endothelial Progenitors|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline, before every course for 3 months, and then every 3 months during treatment for the first year|||||||
1259471|NCT00436956|Secondary|Median Progression Free Survival (PFS)|Time interval from start of treatment to documented evidence of disease progression.|up to 14.9 months based on a Kaplan-Meier analysis.||||Months||95% Confidence Interval|Median
1259433|NCT00437034|Secondary|Proangiogenic Factors Such as VEGF|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline, before every course for 3 months, and then every 3 months during treatment for the first year|||||||
1259434|NCT00437034|Secondary|The Apoptotic State of Tumor Neovasculature|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline and post-treatment (1 week after 2nd dose and end of study)|||||||
1259435|NCT00437034|Secondary|Tissue Expression Patterns of VEGFR Subtypes|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline and post-treatment (1 week after 2nd dose and end of study)|||||||
1259436|NCT00437034|Secondary|Toxicities|Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 terminology. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.|During treatment and follow up|||||||
1259437|NCT00437034|Secondary|Overall Survival (OS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until death, assesseduUp to 6 months|||||||
1259438|NCT00437034|Secondary|Progression-free Survival (PFS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until objective or symptomatic progression, assessed up to 6 months|||||||
1259439|NCT00437034|Primary|Overall Response Rate (Complete [CR] and Partial Response [PR])|"A 95% confidence interval was intended to be estimated via binomial proportions, but was not computed due to small sample size.~Criteria for Response from EBMT, IBMTR, ABMTR: Complete Response:Complete absence of monoclonal protein by immunofixation for a minimum of 6 weeks; Near Complete Response:Absence of serum paraprotein by standard serum/urine protein electrophoresis without disappearance of monoclonal spike by immunofixation; Partial Response:Sustained decrease in production rate of monoclonal serum protein to 50% or less of pretreatment value; Stable Disease: No significant change from baseline; Progression of Disease:Patients with a > or = 25% rise in production rate, new/increased size of lytic lesions/plasmacytomas/progressive marrow plasmacytosis; Symptomatic Deterioration:Patients with deterioration of health requiring discontinuation of treatment w/out objective evidence of disease progression."|At baseline and every 4 weeks during study treatment until treatment discontinuation due to disease progression, unacceptable toxicities and/or patient withdrawal.||||participants|||Number
1259440|NCT00436982|Secondary|Blood Loss|Blood loss during surgery|intra-operative|The protocol indicates blood loss as a secondary measure but this value was not collected. Therefore no data can be posted.||||||
1259441|NCT00436982|Secondary|Duration Hospital Stay||preoperative to discharge||||days||Standard Deviation|Mean
1259442|NCT00436982|Secondary|Mean Operative Time|Skin to skin operative time|intra-operative||||minutes||Standard Deviation|Mean
1259443|NCT00436982|Secondary|Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire|"The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.~NOTE: While the protocol includes pre-operative, 3 months, and 1 year, this data was not collected."|pre-operative, 3 months, 1, 2, 5, 7 and 10 years|Participants with data available at each time point. Overall number of participants and units analyzed is based upon the 2 year population|||units on a scale||Standard Deviation|Mean
1259444|NCT00436982|Secondary|Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire|"KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.~[taken from User Guide] http://www.koos.nu/"|pre-operative, 3 months, 1, 2, 5, 7 and 10 years|Participants with data available at each time point.|||units on a scale||Standard Deviation|Mean
1259445|NCT00436982|Secondary|Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|[Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years]|Participants with data available at each time point.|||units on a scale||Standard Deviation|Mean
1259446|NCT00436982|Secondary|Roentgen Stereophotogrammetric Analysis (RSA)|To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA.|3 months, 1, 5, 7 and 10 years|Participants with data available at each time point.|||mm||Standard Deviation|Mean
1259447|NCT00436982|Primary|Roentgen Stereophotogrammetric Analysis (RSA)|To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.|2 years||||mm||Standard Deviation|Mean
1259472|NCT00436956|Secondary|Median Overall Survival|Time from treatment start date until date of death or date last known alive.|44 months||||Months||95% Confidence Interval|Median
1259473|NCT00436956|Secondary|Number of Grade 3 Toxicities|Here is the number of Grade 3 (severe) toxicities.|61.5 months|Only 58 participants were evaluable for toxicity.|||toxicities|||Number
1259448|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
1259449|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||units on a scale||Standard Error|Least Squares Mean
1259450|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
1259451|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||units on a scale||Standard Error|Least Squares Mean
1259452|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
1259453|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||units on a scale||Standard Error|Least Squares Mean
1259454|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
1259474|NCT00436956|Secondary|Number of Grade 2 Toxicities|Here is the number of Grade 2 (moderate) toxicities.|61.5 months|Only 58 participants were evaluable for toxicity.|||toxicities|||Number
1259455|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||units on a scale||Standard Error|Least Squares Mean
1259456|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
1259457|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||units on a scale||Standard Error|Least Squares Mean
1259458|NCT00436969|Primary|Visual Analog Scale (VAS) Pain Score (As Treated)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|6 Months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
1259459|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
1259460|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||units on a scale||Standard Error|Least Squares Mean
1259461|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
1259475|NCT00436956|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 61.5 months||||Participants|||Count of Participants
1259462|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||units on a scale||Standard Error|Least Squares Mean
1259463|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
1259464|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||units on a scale||Standard Error|Least Squares Mean
1259465|NCT00436969|Secondary|Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~The difference in pain was calculated as visit score - baseline score."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
1259466|NCT00436969|Secondary|Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)|The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
1259467|NCT00436969|Secondary|Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||Percentage of Participants||95% Confidence Interval|Number
1259468|NCT00436969|Secondary|Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||Percentage of Participants||95% Confidence Interval|Number
1259469|NCT00436969|Primary|Visual Analog Scale (VAS) Pain Score (Per Protocol)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|6 Months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
1259470|NCT00436956|Secondary|Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response was evaluated by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Every 2 cycles (approximately 56 days)|One patient was not evaluable owing to the development of a cord compression on day 2 of therapy and was subsequently removed from the trial. Out of 59 patients, 39 had measurable disease.|||Participants|||Count of Participants
1293198|NCT00100698|Secondary|Change in Adiponectin|Change in adiponectin|18 months||||mcg/mL||Standard Error|Mean
1259476|NCT00436956|Primary|Percent Probability of Participants With 6-month Progression-free Survival (PFS)|PFS is the proportion of subjects who progress or die by 6 months after the start of the combined therapy. PFS is determined by prostatic specific antigen (PSA) consensus criteria and the Response Evaluation Criteria in Solid Tumors (RECIST). PSA consensus criteria is defined as PSA decline of >/= 50% or PSA progression. RECIST is defined as the following: Complete response (CR) is disappearance of all target lesions; partial response (PR) is at least a 30% decline in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease ((PD) at least a 20% increase in the sum of the LD of target lesions, or the appearance of one or more lesions), taking as reference the smallest sum LD since the treatment started. Data is estimated and the probability of PFS as a function of time was determined using the Kaplan-Meier method.|6 months|One participant was not evaluable owing to the development of a cord compression on day 2 of therapy and was subsequently removed from the trial. Since the prednisone was added to relieve toxicity & outcome data is based on response, the cohorts were analyzed together in terms of response. No suggestion prednisone significantly altered outcomes.|||percent probability|||Number
1259477|NCT00436917|Secondary|Time to Disease Progression||5 yr|||||||
1259478|NCT00436917|Secondary|Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0||5 yr|||||||
1259479|NCT00436917|Secondary|Femoral Neck BMD as Measured by DXA at Baseline and at 12, 24, 36, 48, and 60 Months||5 yr|||||||
1259480|NCT00436917|Secondary|Total Lumbar Spine BMD as Measured by DXA at Baseline and at 24, 36, 48, and 60 > Months||5 yr|||||||
1259481|NCT00436917|Primary|Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)|Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 1 year|The primary analysis is performed on data where participants had the same baseline and 1 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)|||Percentage of the baseline value||95% Confidence Interval|Mean
1259482|NCT00436904|Secondary|Time to Disease Progression|Calculated from date of registration to date of disease progression. In patients that have not progressed, time to disease progression will be censored at the patient's last evaluation date.|Time from registration to progression (up to 5 years)||||Months||95% Confidence Interval|Median
1259483|NCT00436904|Secondary|Survival|Survival is calculated from the date of registration to the date of death due to any cause. In patients who are still alive, survival will be censored at the last date when the patient was known to be alive.|Death or last follow-up (up to 5 years)|At analysis time, only 1 out of 30 patients had died. Thus, median survival was not attainable.|||Months||95% Confidence Interval|Median
1259484|NCT00436904|Secondary|Duration of Response|Duration of response is calculated from the date of documented response until the date of progression in the subset of patients who respond to treatment. In patients who have not yet progressed, duration of response will be censored at the patient's last evaluation date.|Up to 5 years|Patients that responded were included in the analysis.|||Months||95% Confidence Interval|Median
1259485|NCT00436904|Secondary|Time to Response|Calculated from the date of registration until the first date at which the patient's objective status was classified as a response. In patients who do not achieve a response, time to response will be censored at the patient's last evaluation date. Response is defined the same way as in the response primary outcome measure.|Registration to first response (up to 5 years)||||Days||95% Confidence Interval|Median
1259486|NCT00436904|Primary|Number of Participants With Treatment Related Adverse Events|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. >~> Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE"|Weekly for first 6 weeks, then monthly for 6 months, then at 9 and 12 months post registration||||participants|||Number
1259487|NCT00436904|Primary|Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months|Confirmed response is defined as a > 50% decrease in clinical symptoms from baseline and recovery from blood counts.|Up to 6 months|Number of patients with a confirmed response out of total patients evaluable for response.|||participants||95% Confidence Interval|Number
1259488|NCT00436852|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Toxicity will be tabulated by grade (overall and by course).|yearsFrom enrollment until 30 days after the end of protocol therapy|||||||
1259489|NCT00436852|Secondary|Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0|For each of the items within a Dimension, the QOL score will be reverse linearly transformed to a 0-100 percentage point scale (0=100, 1=75, 2=50, 3=25, 4=0), and the average of all items within a Dimension will be calculated. This results in 4 definitive scores at each timepoint. The average of all 23 items will be the Total Score at a given timepoint; and, 2) the repeated measures of performance status (Karnofsky score for patients > 16 years of age and Lansky score for patients ≤ 16 years of age).|3 weeks|||||||
1259490|NCT00436852|Secondary|Objective Response Rate|The proportion of patients who are responders will be tabulated, including a 95% confidence interval on the proportion.|Duration of protocol therapy|||||||
1259491|NCT00436852|Primary|1-year Progression-free Survival|PFS probabilities calculated using the Kaplan-Meier method, along 95% confidence intervals, separately for each stratum.|From the day of enrollment to the date of disease progression/recurrence , or the date of death (all causes of mortality) if disease progression/recurrence is not reached, assessed up to 1 yr. Pts were to be followed for 5 yrs after completion of therapy|The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).|||percent probability||95% Confidence Interval|Number
1259492|NCT00436852|Primary|Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors|Median time to progression observed on ABT-751, along with 95% confidence intervals.|From time to enrollment to death due to any cause, assessed up to 5.1 years|The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).|||days||95% Confidence Interval|Median
1259493|NCT00436826|Secondary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement. The annualized relapse rate for each treatment group was the mean of the annualized relapse rates for all the participants in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Baseline up to Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.|||relapses per year||95% Confidence Interval|Number
1259494|NCT00436826|Secondary|Number of Combined Unique Active (CUA) Lesions, Active Time Constant 2 (T2) Lesions, and Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, active T2 lesions, and T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans|Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.|||Lesions||Standard Deviation|Mean
1259495|NCT00436826|Secondary|Number of Qualifying Relapses|A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement.|Baseline up to Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.|||Relapses||Standard Deviation|Mean
1259496|NCT00436826|Primary|Percentage of Participants With Adverse Events in Infections and Infestations System Organ Class (SOC)|Adverse Events were entered in infections and infestations SOC as per medical dictionary for regulatory activities (MedDRA) version 11.0|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.|||Percentage of participants|||Number
1259497|NCT00436826|Primary|Percentage of Participants With Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE]) Hematological or Liver Toxicity|Percentage of participants with Grade 3 or 4 CTCAE toxicity on the following hematology and liver function parameters were reported: lymphocytes, cluster of differentiation 4 (CD4) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT) and Aspartate transaminase (AST). According to CTCAE: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.|||Percentage of participants|||Number
1259498|NCT00436826|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.|||Participants|||Number
1259499|NCT00436748|Secondary|Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age|Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).|Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose|Due to the low number of participants <6 years of age summary concentration analyses were not performed.||||||
1259500|NCT00436748|Secondary|Number of Participants Who Developed Anti-erythropoiesis Antibodies|Participants who were negative for anti-erythropoiesis antibodies at Baseline (pre-dose) and who developed anti-erythropoiesis antibodies during the study. Serum samples were tested using Amgen’s Surface Plasmon Resonance Immunoassay (SPRIA) method.|25 weeks|Safety analysis set with both pre and postdose immunoassay antibody results|||participants|||Number
1259501|NCT00436748|Secondary|Change From Baseline in Diastolic Blood Pressure Over Time||Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."|||mmHg||Standard Deviation|Mean
1259502|NCT00436748|Secondary|Change From Baseline in Systolic Blood Pressure Over Time||Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."|||mmHg||Standard Deviation|Mean
1259503|NCT00436748|Secondary|Maximum Increase in Hemoglobin Over Any 2 Week Period|The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.|25 weeks|Safety analysis set|||g/dL/2 weeks||Standard Deviation|Mean
1259504|NCT00436748|Secondary|Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study||25 weeks|Safety analysis set|||participants|||Number
1259505|NCT00436748|Secondary|Hemoglobin Serial Rate of Change (ROC) Over Time|Calculated using the serial method as the change in hemoglobin from the previous non-missing hemoglobin level divided by number of days in between, and then multiplied by 7.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."|||g/dL/week||Full Range|Median
1259517|NCT00436644|Primary|Response Rate (Complete Response (CR) or Partial Response (PR))|"Measurable disease patients: measureable disease is defined as at least one lesion whose longest diameter >= 2cm with conventional techniques or >=1cm with spiral CT~Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart.~Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.~Non-measurable disease patients:~Decrement in CA125 by > 50%~Improvement in other evaluable disease"|Two consecutive evaluations at least 4 weeks apart||||participants|||Number
1259763|NCT00434876|Primary|Sleep Efficiency (From an In-laboratory Polysomnogram)|The fraction of time spent asleep to the total time in bed (%).|Baseline, and week 8 of treatment.||||percentage||Standard Deviation|Mean
1259506|NCT00436748|Secondary|Number of Participants With Treatment-emergent Adverse Events|A serious adverse event (SAE) is defined as an adverse event that meets at least one of the following serious criteria: • is fatal, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • is a congenital anomaly/birth defect, and/or • other significant medical hazard. The investigator assessed whether the adverse event was related to the investigational product (IP). Events of interest included hypertension, ischemic heart disease, cardiac failure, cerebrovascular disorders, convulsions, embolic and thrombotic events, embolic and thrombotic events: venous, embolic and thrombotic events: arterial, embolic and thrombotic events: vessel type unspecified and mixed arterial and venous, dialysis vascular access thrombosis, antibody-mediated pure red cell aplasia, hypersensitivity, lack of efficacy-effect, and malignancies.|25 weeks|Safety analysis set including all participants who received ≥ 1 dose of investigational product.|||participants|||Number
1259507|NCT00436748|Secondary|Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores|The PedsQL child self-reported questionnaire was used in children > 5 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 5-7, 8-12, and 13-18 years was used for child self-reporting. The instructions asked how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale for ages 8 to 18 (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem), or simplified to a 3-point scale for ages 5 to 7 (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item’s score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).|Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)|"Efficacy analysis set aged > 5 years and with available data for each score at each time point (indicated by n)."|||units on a scale||Standard Error|Mean
1259508|NCT00436748|Secondary|Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores|The PedsQL is a health-related quality of life (HRQOL) questionnaire that can be used to measure quality of life in children ≥ 2 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 2 to 4 (toddler), 5-7, 8-12, and 13-18 years are used for parent proxy-reporting, which assesses parents’ perceptions of their child’s HRQOL. The instructions ask how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item’s score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).|Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)|"Efficacy analysis set with available data for each score at each time point (indicated by n)."|||units on a scale||Standard Error|Mean
1259509|NCT00436748|Secondary|Darbepoetin Alfa Weight-Adjusted Dose Over Time|Arithmetic means are provided; Withheld doses are counted as 0 μg.|Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Efficacy analyis set with available data at each time point (indicated by n). Numbers > 0 on non-darbepoetin alfa dosing weeks for the Q2W group reflect participants who did not receive the assigned placebo dose (eg, dose withheld per investigator decision based on hemoglobin value or missed visit)."|||μg/kg||Standard Deviation|Mean
1259510|NCT00436748|Secondary|Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL|The darbepoetin alfa dose at the time a participant achieved a first hemoglobin level ≥ 10.0 g/dL, divided by the participant's weight measured at the closest study week prior to the dosing, post dialysis.|24 weeks|Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL) for whom dosing data were available.|||μg/kg||Standard Deviation|Mean
1259511|NCT00436748|Secondary|Hemoglobin Concentration Over Time||Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Efficacy analyis set with available data at each time point (indicated by n)."|||g/dL||Standard Deviation|Mean
1259512|NCT00436748|Secondary|Time to First Hemoglobin Value ≥ 10.0 g/dL|The time from study Day 1 to the day a participant first achieved hemoglobin ≥ 10.0 g/dL for participants who achieved hemoglobin ≥ 10.0 g/dL.|24 weeks|Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL)|||days||Inter-Quartile Range|Median
1259513|NCT00436748|Primary|Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL|The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set.|24 weeks|Efficacy analysis set|||proportion of participants||95% Confidence Interval|Number
1259514|NCT00436644|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Time from Registration to Death or last follow-up (up to 3 years)||||months||95% Confidence Interval|Median
1259515|NCT00436644|Secondary|Adverse Event Profile|Number of patients that experienced adverse events (grade 3 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Every 4 weeks||||participants|||Number
1259516|NCT00436644|Secondary|Time to Progression|Time to progression was defined as the number of months from registration to the date of disease progression, with patients who are progression free being censored on the date of their last evaluation.|Time from registration to progression (up to 2 years)||||months||95% Confidence Interval|Median
1259518|NCT00436618|Secondary|Time to Progression|The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier.|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.|||years||95% Confidence Interval|Median
1259519|NCT00436618|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier.~Progression is defined as the following:~CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): >=50% increase in nodes from nadir or >=50% increase in liver/spleen size from nadir.~Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% lymph node increase in SPD of > 1 node or new nodes, or >50% liver/spleen size increase, or > 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology.~All Others: New lesions or >=50% lymph nodes."|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.|||years||95% Confidence Interval|Median
1259520|NCT00436618|Secondary|Overall Survival|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier.|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.|||years||95% Confidence Interval|Median
1259521|NCT00436618|Primary|Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.|"CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.~Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions.~All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease."|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.|||percentage of patients in group||95% Confidence Interval|Number
1259522|NCT00436605|Primary|Progression-free Survival|Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon’s optimum two-stage design will be used|Time from start treatment to time of progression, assessed up to 6 months||||weeks||Full Range|Mean
1259523|NCT00436605|Primary|Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria|Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon’s optimum two-stage design will be used.|After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment||||participants|||Number
1259524|NCT00436566|Secondary|Incidence of Pulmonary Events|Pulmonary events to be included were grade 3 and higher pulmonary adverse events at least possibly related to study treatment, which occur at any time after post-AC treatment is begun, but prior to documentation of a breast cancer recurrence, contralateral breast cancer, secondary primary cancer, non-pulmonary death, or pulmonary death not related to study treatment.|5 years|||||||
1259525|NCT00436566|Secondary|Quality-of-life||5 years|||||||
1259526|NCT00436566|Secondary|Comparison of Selected Quality-of-life Questionnaires||5 years|||||||
1259527|NCT00436566|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|5 years|||||||
1259528|NCT00436566|Secondary|Disease-free Survival (DFS)|DFS was defined as the time from registration to the earliest date of documentation of any local, regional, or distant recurrence of breast cancer (BC); the development of a contralateral BC or second primary other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death from any cause without the documentation of one of these events. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|5 years|||||||
1259529|NCT00436566|Secondary|Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) Between Two Time Points||5 years|||||||
1259530|NCT00436566|Secondary|Cumulative Incidence (CI) of Cardiac Events|"Evaluable patients included those completed the AC phase of their treatment regimen; with post AC cardiac evaluation indicates they are eligible to begin treatment with PTL; and those have begun their post-AC therapy.~Cardiac events: symptomatic congestive heart failure (CHF), cardiac death and other cardiac events (NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3)"|5 years|||||||
1259531|NCT00436566|Secondary|Adverse Event Profile as Measured by NCI CTCAE v 3.0|Maximum grade for each type of adverse event will be recorded for each patient.|5 years|||||||
1259532|NCT00436566|Primary|Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment||6 months||||participants|||Number
1259533|NCT00436553|Primary|Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit|The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.|Month 2 up to Month 11|Full analysis set (FAS) - Only the combination groups were analyzed. The percent of subjects with a ranibizumab treatment-free interval of at least 3 months duration following the Month 2 ranibizumab treatment was calculated using the subjects still in the study at Month 5.|||Percent of participants|||Number
1259534|NCT00436553|Secondary|Change From Baseline in Central Retinal Thickness at Month 12|Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.|Baseline and Month 12|Full analysis set (FAS), observed data.|||micrometer||Standard Deviation|Mean
1259535|NCT00436553|Secondary|Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12|The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Month 12|Full analysis set (FAS), observed data.|||Percentage of participants|||Number
1259537|NCT00436553|Primary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 12|The Full analysis set (FAS) consisting of all randomized patients that received at least one application of study drug and had at least one post-baseline assessment for BCVA in the study eye. Last observation carried forward (LOCF) was utilized.|||Letters||Standard Deviation|Mean
1259538|NCT00436501|Primary|Median Progression-Free Survival (PFS) (Phase II)|Progression-Free Survival was calculated from study entry until documented disease, death or date of last contact.|Time from start of treatment to time of progression, assessed up to 6 years.||||months||95% Confidence Interval|Median
1259539|NCT00436501|Secondary|Proportion of Patients With PFS (Phase II)|Progression-free survival (PFS) defined as number of participants out of total in arm that had no disease progression as measured at 6 months. Standard RECIST criteria used to evaluate response and progression. All documented responses required confirmation by imaging, examination, or both, no sooner than 4 weeks after initial documentation of response. In the absence of new symptoms, response assessment was consistently done after two additional cycles of therapy.|6 months|||||||
1259540|NCT00436501|Secondary|Frequency and Severity of Adverse Effects of Treatment as Assessed by NCI CTCAE v3.0 (Phase II)||Up to 6 years|||||||
1259541|NCT00436501|Secondary|Overall Median Duration of Response (Phase II)|Duration of the response from time response is achieved until disease progression is detected. Response assessed following treatment (every 3 weeks) for disease progression. Study duration January 2007 to May 2013, approximately six and half years.|Response assessed following treatment (every 3 weeks), up to 6 years. Study duration January 2007 to May 2013.|Number analyzed represents those Phase II participants with response as documented in Outcome Measure 2.|||months||Full Range|Median
1259542|NCT00436501|Primary|Overall Objective Response Rate According to RECIST (Phase II)|The percentage of participants in the Phase II arm with an objective response defined as a measurable response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Standard RECIST criteria were followed to evaluate response and progression. All documented responses were required to undergo confirmation by imaging, examination, or both, no sooner than 4 weeks after the initial documentation of response. In the absence of new symptoms, this response assessment was consistently done after two additional cycles of therapy.|Up to 6 months||||percentage of participants|||Number
1259543|NCT00436501|Primary|Median Overall Survival (OS) (Phase II)|Overall survival was defined from the date of study entry until death or date of last contact. Median survival time points calculated in the method of Kaplan-Meier. Standard RECIST criteria followed to evaluate response and progression, and all documented responses required confirmation by imaging, examination, or both, no sooner than 4 weeks after the initial documentation of response. In the absence of new symptoms, response assessment consistently done after two additional cycles of therapy.|Time from start of treatment to time of progression, assessed up to 6 years.||||months||Full Range|Median
1259544|NCT00436501|Primary|Number of Participants With Clinical Response (Partial Response or Complete Response) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Frequency of clinical response (partial response or complete response) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance all target lesions; Partial Response (PR): >/= 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >/= 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1+ new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.|Up to 6 months||||participants|||Number
1259545|NCT00436501|Primary|Maximum Tolerated Dose of VEGF Trap (Phase I)|Escalating dose levels of VEGF Trap were administered intravenously over three dose levels (2, 4, or 6 mg/kg; one dose every 21 days) to identify the maximum tolerated dose (MTD). The MTD is defined as the highest dose level below which 2 or more patients encounter a dose limiting toxicity (DLT), graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. MTD established on absence of observed DLT(s) in either cycle 0 (single agent) or cycle 1 (combination therapy) of any given dose level.|21 day cycle, up to 3 cycles||||mg/kg|||Number
1259546|NCT00436436|Secondary|Overall Survival|Defined as the interval between the day of first administration of treatment and the date of death.|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.||||||
1259547|NCT00436436|Secondary|Progression-free Survival|Defined as the interval between the day of first administration of treatment and the first documentation of progressive disease or date of death. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.||||||
1259548|NCT00436436|Secondary|Best Overall Response|Defined as the best tumor response recorded from the start of treatment until disease progression or withdrawal from the study. Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No disease does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.||||||
1267509|NCT00380250|Secondary|Month 3 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|ITT with LOCF|||Scale score||Standard Deviation|Mean
1259550|NCT00436436|Secondary|Objective Tumor Response Rate in Patients With Methylguanine Methyltransferase (MGMT)-Negative Tumors as Assessed by Immunohistochemistry (IHC)|The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No disease does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|2-4 weeks|Twelve patients were enrolled. The principal investigator wished to analyze the data but felt that there was insufficient data to report on and therefore closed the protocol when he left the National Cancer Institute (NCI).||||||
1259551|NCT00436436|Primary|Confirmed Best Objective Tumor Response Rate (Complete or Partial Response) in Patients With Methylguanine Methyltransferase (MGMT)-Positive Tumors as Assessed by Immunohistochemistry (IHC)|The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions.|2-4 weeks|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.||||||
1259552|NCT00436345|Secondary|Pain Intensity From Day 8 to Day 10|“Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Days 8, 9, and 10|mITT Population. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.|||points on a scale||Standard Deviation|Mean
1259553|NCT00436345|Secondary|Pain Intensity (PI)|“Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Up to 38 days|ITT Population, according to the participants' status. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.|||Points on a scale||Standard Deviation|Mean
1259554|NCT00436345|Secondary|Bispectral Index (BIS) for Extubation Period and Post-Extubation Period|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|up to 38 days|mITT Population. The BIS value was recorded only for 2 participants, in the extubation and post-extubation periods.|||points on a scale||Standard Deviation|Mean
1259555|NCT00436345|Secondary|Bispectral Index (BIS) for Day 5|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Day 5|mITT Population. At Day 5, only one participant remained in the study; the others were already extubated.|||points on a scale||Standard Deviation|Mean
1259556|NCT00436345|Secondary|Bispectral Index (BIS)|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Screening through End of Study, up to 38 days|mITT Population. Due to the nonmandatory nature of BIS measure in the clinical practice, some participants did not have all the measures for all days in which they were in the study.|||Points on a scale||Standard Deviation|Mean
1259557|NCT00436345|Secondary|Number of Participants Analyzed for BIS (Bispectral Index Scale)|Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Up to 38 days|mITT Population|||participants|||Number
1259558|NCT00436345|Secondary|Sedation-Agitation From Day 8 to Day 10|“Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.|Days 8, 9, and 10|mITT Population according to the participants’ status|||points on a scale||Standard Deviation|Mean
1259559|NCT00436345|Secondary|Sedation-Agitation for Day 7|“Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.|Day 7|mITT Population according to the participants’ status|||points on a scale||Standard Deviation|Mean
1259560|NCT00436345|Secondary|Sedation-Agitation From Screening Through the End of Study|"Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable."|Up to 38 days|mITT Population, according to the participants’ status|||Points on a scale||Standard Deviation|Mean
1259561|NCT00436345|Secondary|Number of Participants Analyzed for Sedation – Agitation Scale (SAS) and Pain Intensity (PI) Scale|Data from participants in the study for which the Sedation–Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. “Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. “Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Up to 38 Days|mITT Population|||participants|||Number
1259786|NCT00434356|Secondary|Adverse Events Leading to Death|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients|||participants|||Number
1259563|NCT00436345|Secondary|Total Dose of Propofol Administered - Bolus|Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Propofol were analyzed.|||mg/kg||Standard Deviation|Mean
1259564|NCT00436345|Secondary|Dose of Morphine Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days|ITT Population. Only participants dosed with Morphine were analyzed.|||mg/kg/h||Standard Deviation|Mean
1259565|NCT00436345|Secondary|Dose of Propofol Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Propofol were analyzed.|||mg/kg/h (milligrams per kilogram per hr)||Standard Deviation|Mean
1259566|NCT00436345|Secondary|Doses of Sufentanil and Fentanil Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days|ITT Population. Only participants dosed with Remifentanil were analyzed.|||ug/kg/h||Standard Deviation|Mean
1259567|NCT00436345|Secondary|Dose of Remifentanil Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Remifentanil were analyzed.|||ug/kg/h (micrograms per kilogram per hr)||Standard Deviation|Mean
1259568|NCT00436345|Secondary|Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days (240 hours)|ITT Population. Only participants infused with Sufentanil, Fentanil, and Morphine were analyzed.|||hours||Standard Deviation|Mean
1259569|NCT00436345|Secondary|Duration of Propofol Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days (240 hours)|ITT Population. Only participants infused with Propofol were analyzed.|||hours||Standard Deviation|Mean
1259570|NCT00436345|Secondary|Duration of Remifentanil Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days (240 hours)|ITT Population. Only participants infused with Remifentanil were analyzed.|||Hours||Standard Deviation|Mean
1259571|NCT00436345|Secondary|Duration of Weaning|Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.|up to 38 days (912 hours)|ITT Population. Only participants for which data are available were analyzed.|||hours||Standard Deviation|Mean
1259572|NCT00436345|Secondary|Duration of Extubation|Duration of extubation was measured.|up to 38 days (912 hours)|ITT Population. Only participants with available extubation data were analyzed.|||hours||Standard Deviation|Mean
1259573|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Per-Protocol Population)|Time from start of mechanical ventilation until actual extubation|Up to 38 days (912 hours)|Per-Protocol (PP) Population: all participants from the MITT population without any major protocol violation|||Hours||Standard Error|Mean
1259574|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)|Time from start of mechanical ventilation until actual extubation.|Up to 38 days (912 hours)|Modified-Intent-to-Treat (mITT) Population: all randomised participants who had taken at least one dose of study medication and who had efficacy measurements|||Hours||Standard Error|Mean
1259575|NCT00436345|Secondary|Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator’s Decision)|Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.|Up to 38 days (912 hours)|ITT Population. Only participants with available ICU data were analyzed.|||Hours||Standard Deviation|Mean
1259576|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)|Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).|Up to 38 days (912 hours)|Intent-to-Treat (ITT) Population: all randomised participants who had taken at least one dose of study medication|||Hours (hr)||Standard Error|Mean
1259577|NCT00436332|Secondary|Frequency and Severity of Toxicities||From date of registration to maximum of 3 years|Number of Subjects With Greater Than Grade 2 Toxicity|||participants|||Number
1259578|NCT00436332|Secondary|Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease|Images for response assessed by the central computer-assisted image-analysis system were never collected.|From date of registration to maximum of 3 years||||Participants|||Count of Participants
1259579|NCT00436332|Secondary|Progression-free Survival||From date of registration to maximum of 3 years||||months||95% Confidence Interval|Median
1259580|NCT00436332|Primary|Overall Survival||From date of registration to maximum of 3 years||||months||95% Confidence Interval|Median
1259581|NCT00436215|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|up to 28 months||||Participants|||Count of Participants
1259582|NCT00436215|Secondary|Progression-free Survival|Progression free survival is defined by the number of weeks between the first day of treatment and the date of cancer progression.|up to 28 months||||Weeks||Standard Deviation|Mean
1259619|NCT00435994|Primary|Lung Function|Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.|Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)|All participants who had baseline, post bronchodilator and post epinephrine measurements were included. Participants in the Bronchiolitis arm did not have infant pulmonary functions obtained.|||Z score||Standard Deviation|Mean
1259583|NCT00436215|Primary|Clinical Response Rate.|Clinical response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started lasting at least 6 months.|patients were followed for a median of 18 weeks (range 1-116 weeks)|Seven patients were not evaluable for response assessment.|||percentage of participants|||Number
1259584|NCT00436163|Secondary|Percentage of Anti-HBe Positive Participants|HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.|||percentage of participants|||Number
1259585|NCT00436163|Secondary|Percentage of HBeAg Negative Participants|HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.|||percentage of participants|||Number
1259586|NCT00436163|Secondary|Mean Alanine Aminotransferase (ALT) Concentrations||Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.|||international units per liter (IU/L)||Standard Deviation|Mean
1259587|NCT00436163|Secondary|Percentage of Anti-HBs Positive Participants|HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.|||percentage of participants|||Number
1259588|NCT00436163|Secondary|Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants|HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.|||percentage of participants|||Number
1259589|NCT00436163|Secondary|Number of Participants With HBV-DNA < 400 Copies/mL||Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1259590|NCT00436163|Primary|Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL|HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.|Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg negative at baseline.|||participants|||Number
1259591|NCT00436163|Primary|Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)|HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.|Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg positive at baseline.|||participants|||Number
1259592|NCT00436046|Other Pre-specified|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 28 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.|28 days after immunization||||Participants|||Number
1259593|NCT00436046|Secondary|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.|28 days after immunization||||Participants|||Number
1259594|NCT00436046|Primary|Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 28 after immunization, relative to pre-immunization levels.|28 days after immunization.||||Participants|||Number
1259595|NCT00436046|Other Pre-specified|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.|14 days after immunization||||Participants|||Number
1259620|NCT00435942|Primary|Primary Safety Endpoint: Distribution of Major Adverse Events|The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure|1 year|The number of subjects who underwent the endovascular procedure or open surgical repair|||participants|||Number
1259596|NCT00436046|Secondary|Unsolicited Adverse Events After Intranasal Immunization|Number of subjects (frequency) with spontaneous reports of Adverse Events of any severity and severe or higher severity, during the 28 days after vaccination regardless of relatedness. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.|Non-serious AEs are collected through 28 days after vaccination. Serious AEs are collected through 180 days after vaccination.|A reporting threshold of 5.6% was selected after reviewing adverse event rates in healthy adult volunteers in similar studies sponsored by NIAID. We determined 5.6% to be the upper bound of the confidence interval to exclude reporting events that occur in 75% of healthy adults.|||Participants|||Number
1259597|NCT00436046|Secondary|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.|14 days after immunization.||||Participants|||Number
1259598|NCT00436046|Secondary|Local and/or Systemic Solicited Symptoms After Intranasal Immunization.|Number of participants (frequency) reporting solicited (systematically collected on a Memory Aid) reactogenicity events of any severity and number reporting severe occurrences.|0-7 days following immunization||||Participants|||Number
1259599|NCT00436046|Primary|Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 14 after immunization, relative to pre-immunization levels|14 days after immunization.||||Participants|||Number
1259600|NCT00436007|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 19|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1259601|NCT00436007|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were assessed following vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.|During the 30-day (Days 0-29) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1259602|NCT00436007|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever [axillary temperature equal or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite following any vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.|During the 7-day (Days 0-6) follow-up period after any vaccination|The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.|||subjects|||Number
1259603|NCT00436007|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site following vaccination with each of the following study vaccines administered intramuscularly, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. The numbers of subjects with each of the assessed solicited local symptoms reported were tabulated for each vaccine administered, separately.|During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines.|The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.|||subjects|||Number
1259604|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1259605|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antiibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 2 Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1259606|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antibody antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 1 Group.|At Months 0, 1, 3 and 7.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1259674|NCT00435409|Secondary|Percent Chance of Participant Survival|Probability of survival 2 years and 3 years after the first dose of study treatment.|Year 1, Year 2, Year 3|ITT population|||probability of survival||95% Confidence Interval|Number
1259765|NCT00434759|Primary|Change From Baseline in Social Phobia Scale (SPS)|The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
1259607|NCT00436007|Secondary|Titers for Anti-yellow Fever Antibodies.|"Anti-yellow fever antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 10. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.~The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups."|At Months 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||titers||95% Confidence Interval|Geometric Mean
1259608|NCT00436007|Secondary|Concentrations of Anti-measles Antibodies.|Anti-measles antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seropositivity assay cut-off was 150 mIU/mL. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.|At Months 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1259609|NCT00436007|Secondary|Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.|Anti-BPT antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 15 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1259610|NCT00436007|Secondary|Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).|Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||titers||95% Confidence Interval|Geometric Mean
1259611|NCT00436007|Secondary|Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.|Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1259612|NCT00436007|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 8 to Month 19|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1259613|NCT00436007|Secondary|Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1259614|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1259615|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 2 Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1259616|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 1 Group.|At Months 0, 1, 3 and 7.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1259617|NCT00436007|Primary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1259621|NCT00435942|Primary|Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects|"The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure.~The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met."|1 year|All subjects who underwent the Relay implant procedure (Intention to Treat)|||participants|||Number
1259622|NCT00435929|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Abnormal ECG findings included are high and low Heart Rate (HRT), high and low PQ/PR interval (PQ/PR), high and low QRS interval (QRS), high and low QT interval (QT), high and low QTCB interval (QTcB), high and low QTcF interval (QTcF), high and low RR interval (RR), high and low T Wave, high and low U Wave, high and low ECG. The 12 Lead ECG was recorded after participants were in a semi-supine position for at least 5 minutes. Only participants with abnormal ECG findings are presented in the table below.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.|||participants|||Number
1259623|NCT00435929|Secondary|Number Participants With Abnormal Vital Signs|Abnormal Vital signs included are high and low Pulse rate (PR), high and how Temperature (Temp), high and low Systolic Blood Pressure (SBP) and high and low Diastolic Blood Pressure (DBP). Vital signs (SBP, DBP, PR,Temp) were measured after participants were in a semi-supine position for at least 5 minutes.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.|||participants|||Number
1259624|NCT00435929|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters|Laboratory parameters specified in Clinical Operating Guidelines (COG) were summarized. AIDS Clinical Trial Group (ACTG) and American Heart Association (AHA) criteria were used to grade COG laboratory test values. Laboratory parameters for which an increase to Grade 3 (G3) or Grade 4 (G4) occurred are presented in the table below.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.|||participants|||Number
1259625|NCT00435929|Secondary|Cluster of Differentiation 4 (CD4 ) Count|The pharmacodynamic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the cluster of differentiation 4 (CD4) count in participants in each group.|Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35)|PD analysis population: All participants who received at least 1 dose of the study medication and had at least 1 pharmacodynamic (PD) measure were included in the PD analysis population.|||cells/cubic millimeter||Standard Deviation|Mean
1259626|NCT00435929|Secondary|Volume of Distribution (Vd) of SQV and RTV|Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the Vd of SQV and RTV The Vd was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||Litres||Standard Deviation|Mean
1259627|NCT00435929|Secondary|Plasma Clearance After Oral Administration (CL/F) of SQV and RTV|The CL/F is the oral clearance; that is clearance based on oral bioavailability. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the plasma clearance after oral administration (CL/F)of SQV and RTV The CL/F was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||L/hr||Standard Deviation|Mean
1259628|NCT00435929|Secondary|Minimum Observed Plasma Concentration (Cmin) of SQV and RTV|Cmin is the minimum blood plasma concentration that a drug achieves. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the minimum observed plasma concentration (C min) of SQV and RTV The Cmin was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||ng/mL||Standard Deviation|Mean
1259629|NCT00435929|Secondary|Terminal Half-life (T1/2) of SQV and RTV|Terminal half-life is the time measured for the plasma concentration to decrease by one half. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the terminal half-life (T1/2) of SQV and RTV. The T1/2 was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||hour||Standard Deviation|Mean
1259630|NCT00435929|Secondary|Time of Maximum Plasma Concentration (Tmax) of SQV and RTV|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the time of maximum plasma concentration of SQV and RTV. The Tmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||hour||Standard Deviation|Mean
1259925|NCT00433745|Primary|Cellular Immune Response|Minimum criterion for a cellular immune response was defined as the emergence of detectable T cell frequency against Willm's tumor 1 (WT1) when the pre-study analysis found no response, or a twofold increase in T cell frequency at any post vaccination time point|7 weeks after last dose of vaccine||||participants|||Number
1259631|NCT00435929|Primary|Maximum Observed Plasma Concentration (Cmax) of SQV and RTV|The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||ng/mL||Standard Deviation|Mean
1259632|NCT00435929|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)|Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||ng*hr/mL||Standard Deviation|Mean
1259633|NCT00435825|Secondary|Quantitative HBV-DNA 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.|||IU/mL Log10||95% Confidence Interval|Mean
1259634|NCT00435825|Secondary|Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment|Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.|||U/L||95% Confidence Interval|Mean
1259635|NCT00435825|Secondary|Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment|Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA <2,000 IU/ml (Less than 10,000 copies/mL).|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259636|NCT00435825|Secondary|Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment|Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259637|NCT00435825|Secondary|Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of < 2,000 IU/mL (Less than 10,000 copies/mL) is reported.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259638|NCT00435825|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of < 20,000 IU/mL (Less than 100,000 copies/mL) is reported.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259639|NCT00435825|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT)|Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259766|NCT00434759|Secondary|Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)|The scale measures depressive symptoms on 20 items on a 4-point scale (range of scores is 0-3; minimum for all 20 items is 0, maximum 60). Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
1259640|NCT00435825|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment|Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259641|NCT00435825|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259642|NCT00435825|Secondary|Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment|Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the Per protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259643|NCT00435825|Secondary|Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72|Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.|Week 72|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259644|NCT00435825|Primary|Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment|Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1259645|NCT00435812|Secondary|Percentage of Participants With Local and Systemic Reactions to Injections||Within 7 days post-injection for Post Injection Reactions|Safety Analysis Population: All participants who received at least 1 study injection and had any post-baseline data.|||Percentage of subjects|||Number
1259646|NCT00435812|Primary|Percentage of Subjects With Seroprotective Immune Response|Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)|Week 12 for HEPLISAV and Week 28 for Engerix-B|Per Protocol Population: Subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges, and had serology at their primary endpoint (Week 12 for HEPLISAV group and Week 28 for Engerix-B group)|||Percentage of Participants|||Number
1259647|NCT00435591|Secondary|Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours|"Patients with confirmed serum sodium level exceeding 6 mEq/L increase from baseline or confirmed normal serum sodium level exceeding 135 mEq/L.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|0-24.5 hours, 0-48.5 hours and 0-96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."|||Participants|||Number
1259648|NCT00435591|Secondary|Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours|"Patients with confirmed serum sodium level exceeding 4 mEq/L increase from baseline.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|0-24.5 hours, 0-48.5 hours and 0-96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."|||Participants|||Number
1259649|NCT00435591|Secondary|Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period|"The upper limits of the interquartile range were not estimable in three of the treatment arms. Only the “placebo loading dose + YM087 premix continuous infusion” arm will be reported.~Time is number of hours to reach an increase of exceeding 4 mEq/L from baseline serum sodium.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|48.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."|||Hours||Inter-Quartile Range|Median
1259926|NCT00433654|Secondary|Ventricular Sensed Amplitude|Average ventricular sensed amplitude.|3 or 4 months post-implant||||millivolt (mV)||Standard Deviation|Mean
1259650|NCT00435591|Secondary|Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours|"AUCna t is calculated as the baseline-adjusted area under serum sodium levels for a duration of time 0 to time t.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|24.5 hours, 48.5 hours and 96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."|||hr * mEq/L||Standard Deviation|Mean
1259651|NCT00435591|Secondary|Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period|"Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.~Change from Baseline is calculated as Time point minus Baseline."|Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants analyzed per arm represents Full Analysis Set. The numbers of participants for each time point are noted in the category titles."|||mmol/L||Standard Deviation|Mean
1259652|NCT00435591|Primary|Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2|"Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion.~One ISRMS has been reported for each participant & represents the most severe state of ISR for that participant.~ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis"|48 hours|"Population is Safety Analysis Set (SAF): All randomized patients who received at least 1 dose of study drug.~The number of participants per arm is consistent for all categories of the data table."|||Participants|||Number
1259653|NCT00435539|Primary|Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.||Day 14|Intention to Treat (ITT)|||percentage of participants|||Number
1259654|NCT00435539|Secondary|Resolution of Vitreomacular Traction (Investigator's Assessment)|Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.|Day 28|Intention to Treat (ITT)|||Percentage of participants|||Number
1259655|NCT00435487|Secondary|Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria|Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%.|End of hospitalization, Day 30|Evaluable population|||participants|||Number
1259656|NCT00435487|Secondary|Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization|Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically.|End of hospitalization, Day 30|Evaluable population|||participants|||Number
1259657|NCT00435487|Secondary|Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days|Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase – myocardial band (CPK-MB) levels and the qualitative troponin-T test.|End of hospitalization, Day 30|Evaluable population|||participants|||Number
1259658|NCT00435487|Secondary|Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization|Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization.|End of hospitalization, Day 30|Evaluable population|||participants|||Number
1259659|NCT00435487|Secondary|Number of Subjects With Stroke|Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma).|End of hospitalization, Day 30|Evaluable population|||participants|||Number
1259660|NCT00435487|Primary|Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30|Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase – myocardial band (CPK-MB) levels and the qualitative troponin-T test.|Baseline to Day 30|Evaluable population: all subjects who took study medication for at least 48 hours from baseline and had complete information on the endpoint.|||participants|||Number
1259675|NCT00435409|Secondary|Overall Survival (OS)|Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.|Baseline until death or up to 3 years from first dose|ITT population|||months||95% Confidence Interval|Median
1259927|NCT00433654|Secondary|Atrial Sensed Amplitude|Average atrial sensed amplitude.|3 or 4 months post-implant||||millivolt (mV)||Standard Deviation|Mean
1259661|NCT00435461|Secondary|Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)|The NRQLQ is a paper instrument administered on the day of randomization and at Visit 4/Early Withdrawal to assess nocturnal rhinitis-related quality of life. The NRQLQ is a 16-item, self-administered, disease-specific (allergic rhinitis), and quality of life instrument that measures the functional problems most troublesome to patients with nocturnal allergy symptoms over a one-week interval. Each question is scored from 0 to 6 with higher scores indicating more nocturnal impairment. Items are grouped into four domains: Sleep problems, Sleep time problems, Symptoms on waking in the morning and Practical problems. An overall score was calculated from the mean score of all items. Each participant's average change from Baseline NRQLQ score was the participant's average NRQLQ score over the treatment period minus the participant's baseline score.|Baseline (Day 1) and Day 15|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
1259662|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF)|PNIF was measured by participants using an In-Check Nasal portable hand-held inspiratory flow meter and face mask. Participants recorded PNIF twice daily (in the morning prior to taking their study medication and in the evening). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Each participant's average change from Baseline PNIF was the participant's average PNIF over the treatment period minus the participant's baseline PNIF.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Liter(L)/minute (min)||Standard Error|Mean
1259663|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS)|Participants were instructed to score and document their symptoms in an instantaneous manner on a diary card. The instantaneous rating was performed once daily just prior to administering their morning dose. The scores of each of the instantaneous nasal symptoms (nasal congestion, itching, rhinorrhea, and sneezing) and ocular symptoms (tearing/watering, itching/burning, and redness) were summed for each participant to create a iTNSS and iTOSS, respectively using a 4-point scale, 0- ‘None’ (symptom is not present), 1- ‘Mild’ (sign/symptom present; easily tolerated), 2- ‘Moderate’ (sign/symptom bothersome but tolerable), 3- ‘Severe’ (sign/symptom hard to tolerate; interference with activities of daily living). Total score ranged from 0 (best) to 12 (worst) for iTNSS and 0 (best) to 9 (worst) for iTOSS. Each participant's average change from Baseline iTNSS and iTOSS was participant's average iTNSS and iTOSS total score over the treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Mean
1259664|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS)|Daily 24-hour rTOSS was calculated as the average of the corresponding N-rTOSS and D-rTOSS using a 4-point scale, 0- ‘None’ (symptom is not present), 1- ‘Mild’ (sign/symptom present; easily tolerated), 2- ‘Moderate’ (sign/symptom bothersome but tolerable), 3- ‘Severe’ (sign/symptom hard to tolerate; interference with activities of daily living). The total score ranged from 0 (best) to 9 (worst). The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date’s 24-hour total symptom score was missing, then the 24-hour total symptom score itself was to be set to missing. Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participant's average 24-hour total symptom score over the treatment period minus the participant's Baseline score. Baseline is the 4 highest scores calculated for the 7 days prior to Day 1.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
1259665|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS)|The Daytime reflective assessments were recorded each evening and assessed the 3 nasal symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale where, 0- ‘None’ (symptom is not present), 1- ‘Mild’ (sign/symptom present; easily tolerated), 2- ‘Moderate’ (sign/symptom bothersome but tolerable), 3- ‘Severe’ (sign/symptom hard to tolerate; interference with activities of daily living). The scores of each of the three Daytime symptoms were summed for each participant to create a D-rTOSS for each day. The total score ranged from 0 (best) to 9 (worst). Each participants Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
1259666|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS)|The nighttime reflective assessments were recorded each morning and assessed 3 ocular symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale, 0- ‘None’ (symptom is not present), 1- ‘Mild’ (sign/symptom present; easily tolerated), 2- ‘Moderate’ (sign/symptom bothersome but tolerable), 3- ‘Severe’ (sign/symptom hard to tolerate; interference with activities of daily living). Scores of each of 3 Nighttime symptoms were summed for each participant to create a N-rTOSS for each day. The total score ranged from 0 (best) to 9 (worst). Each participants Baseline total score was average of nighttime total symptom score on day of randomization and the 3 highest scores calculated for 6 days immediately prior to the day of randomization. Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
1259699|NCT00435162|Secondary|Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)||week 6 and week 8|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1259667|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score|Daily 24-hour rTNSS was calculated as the average of the corresponding N-rTNSS and D-rTNSS using a 4-point scale where, 0- ‘None’ (symptom is not present), 1- ‘Mild’ (sign/symptom present; easily tolerated), 2- ‘Moderate’ (sign/symptom bothersome but tolerable), 3- ‘Severe’ (sign/symptom hard to tolerate; interference with activities of daily living). The total score ranged from 0 (best) to 12 (worst). The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date’s 24-hour total symptom score was missing, then the 24-hour total symptom score itself were to be set to missing. Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participants average 24-hour total symptom score over the treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
1259668|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS|The Daytime reflective assessments were recorded each evening and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) at evening and night using a 4-point scale, 0- ‘None’ (symptom is not present), 1- ‘Mild’ (sign/symptom present; easily tolerated), 2- ‘Moderate’ (sign/symptom bothersome but tolerable), 3- ‘Severe’ (sign/symptom hard to tolerate; interference with activities of daily living). The scores of each of the four Daytime symptoms were summed for each participant to create a D-rTNSS for each day. The total score ranged from 0 (best) to 12 (worst). Each participant's Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participants Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
1259669|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score|The nighttime reflective assessments were recorded each morning and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) at evening and night using a 4-point scale, 0- ‘None’ (symptom is not present), 1- ‘Mild’ (sign/symptom present; easily tolerated), 2- ‘Moderate’ (sign/symptom bothersome but tolerable), 3- ‘Severe’ (sign/symptom hard to tolerate; interference with activities of daily living). Scores of each of the 4 symptoms were summed for each participant to create a N-rTNSS for each day. The total score ranged from 0 (best) to 12 (worst). Each participant's Baseline total score was average of nighttime total symptom score on day of randomization and 3 highest scores calculated for 6 days immediately prior to day of randomization. Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over the treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
1259670|NCT00435461|Primary|Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS)|The NSS is a three-item questionnaire which assesses three aspects of allergic rhinitis symptoms at night which were rated using three 4-point scales, the sum of which comprises NSS. The total score ranged from 0 (best) to 9 (worst). The symptoms were: PM nasal congestion upon awakening (PMNCA) (0- None, 1- Mild, 2- Moderate, 3- Severe), difficulty in going to sleep due to nasal symptoms (DSNS) (0- Not at all, 1- Little, 2- Moderately, 3- Very), and nighttime awakenings due to nasal symptoms (NANS) (0- Not at all, 1- Once, 2- More than once, 3- I felt like I was awake all night). Each participant's Baseline NSS was defined as the average of the NSS calculated for the day of randomization and the three highest NSS scores calculated during the six days immediately prior to the day of randomization. Each participant's average change from Baseline NSS for Weeks 1-2 was the participant's average NSS over the treatment period minus the participant's Baseline NSS.|Baseline (Day 1) and up to 2 Weeks|Intent-to-treat (ITT) population included all participants randomized to double-blind treatment. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
1259671|NCT00435409|Secondary|Change From Baseline in EuroQol Group’s EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Day 1 of each treatment cycle (up to 3 years or end of treatment)|PRO assessments were not analyzed because the study did not meet its primary endpoint.|||Score on a scale||95% Confidence Interval|Mean
1259672|NCT00435409|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of each treatment cycle (up to 3 years or end of treatment)|PRO assessments were not analyzed because the study did not meet its primary endpoint.|||Score on a scale||Standard Deviation|Mean
1259673|NCT00435409|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms|Day 1 of each treatment cycle (up to 3 years or end of treatment)|Patient Reported Outcomes (PRO) assessments were not analyzed because the study did not meet its primary endpoint.|||score on a scale||Standard Deviation|Mean
1259676|NCT00435409|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.|Baseline until response or disease progression (up to 3 years from first dose)|ITT subgroup of participants with a confirmed objective tumor response.|||months||95% Confidence Interval|Median
1259677|NCT00435409|Secondary|Percentage of Participants With Objective Response (OR)|Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.|Baseline until response or disease progression (up to 3 years from first dose)|ITT population|||percentage of participants||95% Confidence Interval|Number
1259678|NCT00435409|Primary|Progression Free Survival (PFS)|Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.|Baseline until disease progression (up to 3 years from first dose)|Intent to treat (ITT) population: defined as all participants who were randomized|||months||95% Confidence Interval|Median
1259679|NCT00435370|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains|"The following 8 scales are combined into a single index that is normalized with a mean score of 100 and a standard deviation of 10. Higher scores are considered better cognitive performance. No subscales scores are reported and a final standardized score is reported as the average of the standardized scores on each of these scales. Here is the listing of component scales that were translated into Chinese and used for this study:~Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding Trail Making Test: Part A Attention/Vigilance Continuous Performance Test—Identical Pairs (CPT-IP)* Wechsler Memory Scale®—3rd Ed. (WMS®-III): Spatial Span + Letter-Number Span Hopkins Verbal Learning Test—Revised™ (HVLT-R™) Brief Visuospatial Memory Test—Revised (BVMT-R™) Neuropsychological Assessment Battery® (NAB®): Mazes~Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT™):"|end of 12 wk treatment||||units on a scale||Standard Deviation|Mean
1259680|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|12 month||||meters||Standard Deviation|Mean
1259681|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|3 month||||meters||Standard Deviation|Mean
1259682|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|Baseline||||meters||Standard Deviation|Mean
1259683|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|12 month||||units on a scale||Standard Deviation|Mean
1259684|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|3 month||||units on a scale||Standard Deviation|Mean
1259685|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|Baseline||||units on a scale||Standard Deviation|Mean
1259686|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|12 month||||participants|||Number
1259687|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|3 month||||participants|||Number
1259688|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|Baseline||||participants|||Number
1259689|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|12 month||||times per week||Standard Deviation|Mean
1259690|NCT00435188|Primary|Rapid Gait Speed||12-month||||meters/second||Standard Deviation|Mean
1259691|NCT00435188|Primary|Rapid Gait Speed||3-month||||meters/second||Standard Deviation|Mean
1259692|NCT00435188|Primary|Rapid Gait Speed||Baseline||||meters/second||Standard Deviation|Mean
1259693|NCT00435188|Primary|Usual Gait Speed||12-month||||meters/second||Standard Deviation|Mean
1259694|NCT00435188|Primary|Usual Gait Speed||3 month||||meters/second||Standard Deviation|Mean
1259695|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|3 month||||times per week||Standard Deviation|Mean
1259696|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|Baseline||||times per week||Standard Deviation|Mean
1259697|NCT00435188|Primary|Usual Gait Speed|Best of two trials over 8-foot walk|Baseline||||meters/second||Standard Deviation|Mean
1259698|NCT00435162|Secondary|Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)||week 6 and week 8|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1259702|NCT00435045|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 16|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259703|NCT00435045|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 12|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259704|NCT00435045|Secondary|Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Adiponectin is a protein hormone that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259705|NCT00435045|Secondary|Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Remnant-like particle cholesterol within the plasma has been identified as a cardiovascular risk factor.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259706|NCT00435045|Secondary|Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Intermediate Density Lipoprotein, or IDLs, transport cholesterol and triglycerides through the body. IDLs are a type of cholesterol that are a product of VLDL degradation and result in LDL cholesterol when broken down.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259707|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259708|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis. Chylomicrons are One of the microscopic particles of emulsified fat found in the blood and lymph and formed during the digestion of fats.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259709|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259710|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|High Density Lipoprotein partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259711|NCT00435045|Secondary|Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Lipoprotein Phosphoslipase A2 - modified form of LDL.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259767|NCT00434759|Secondary|Change From Baseline in Brief Symptom Inventory (BSI)|The scale measures general psychopathology on 53 items on a 5-point scale (range of scores is 0-4). Minimum for all 53 items is 0, maximum is 212. Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
1259712|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease. Researchers have linked LDL particle size to the subsequent development of heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259713|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259714|NCT00435045|Secondary|Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Eicosapentaenoic acid (EPA) is one of several omega-3 fatty acids used by the body. It is found in cold water fatty fish and in fish oil supplements, along with docosahexaenoic acid (DHA). Omega-3 fatty acids are part of a healthy diet that helps lower risk of heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259715|NCT00435045|Secondary|Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Docosahexaenoic Acid is an omega-3 essential fatty acid.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259716|NCT00435045|Secondary|Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period||Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259717|NCT00435045|Secondary|Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Total cholesterol/High density lipoprotein cholesterol|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259718|NCT00435045|Secondary|Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Apolipoprotein C-III (APOC3) is a very low density lipoprotein (VLDL) protein. APOC3 inhibits lipoprotein lipase and hepatic lipase; it is thought to delay catabolism of triglyceride-rich particles.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259719|NCT00435045|Post-Hoc|Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|"Apolipoprotein B is the primary apolipoprotein of low density lipoproteins (LDL or bad cholesterol), which is responsible for carrying cholesterol to tissues."|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259720|NCT00435045|Secondary|Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Apolipoprotein A1 - major protein component of high density lipoprotein (HDL) in plasma. The protein promotes cholesterol efflux from tissues to the liver for excretion.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259721|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|VLDL - very-low-density lipoprotein: a plasma lipoprotein with a high lipid content, associated with atherosclerosis.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259722|NCT00435045|Secondary|Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Triglycerides - A naturally occurring ester of three fatty acids and glycerol that is the chief constituent of fats and oils.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259787|NCT00434356|Secondary|Grade ≥ 3 Adverse Events (AEs)|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Grading: 1=Mild AE; 2=Moderate AE; 3=Severe AE; 4=Life-threatening or disabling AE; 5=Death related to AE|30 days following the last administration of study treatment|Treated patients|||participants|||Number
1259723|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|LDL - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
1259724|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|"HDL - A complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.~High density lipoprotein cholesterol is the Total Cholesterol minus the sum of the LDL, VLDL and IDL."|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259725|NCT00435045|Secondary|Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Total Cholesterol is the sum of the High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), Very Low Density Lipoproteins (VLDL), and Intermediate Density Lipoproteins (IDL).|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259726|NCT00435045|Primary|Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 8|Modified Intent To Treat (MITT) Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
1259727|NCT00435019|Secondary|Observed Insulin Antibody Values|Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.|at 0 and 52 weeks|Safety analysis set (SAS): All randomised subjects exposed to at least one dose of trial product, classified according to actual treatment. In some cases, antibody samples were taken earlier than required. These results were not included. A shipment of antibody samples was lost during transportation, and thus these antibody data were missing.|||Percent bound of total||Standard Deviation|Mean
1259728|NCT00435019|Secondary|Number of Subjects Reporting Adverse Events|"Number of subjects reporting adverse events during the trial (from week -2 to week 52).~For details, please refer to the adverse events section."|from week -2 to week 52|Safety analysis set (SAS): all randomised subjects exposed to at least one dose of trial product, classified according to actual treatment.|||participants|||Number
1259729|NCT00435019|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.|after 52 weeks of treatment|Full Analysis Set (FAS) is defined as all randomised subjects exposed to at least one dose of trial product with a postbaseline observation, classified according to randomised treatment.|||Percent (%) glycosylated haemoglobin||Standard Error|Mean
1259730|NCT00434993|Secondary|Plasma Levels of IL-6 and IL-8 on Study Day 3|Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon’s test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes.|Measured at baseline and 3 days after randomization|Not all subjects had available data for secondary analyses and therefor the numbers will be less than the 152 (active) and 130 (placebo) arms.|||pg/ml||Standard Deviation|Log Mean
1259731|NCT00434993|Secondary|Hospital Mortality up to Day 60 in Subjects With Baseline Shock|Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).|Determined 60 days after a subject entered the study|Patients with protocol defined shock (mean arterial pressure<60 or need for vasopressors except dopamine < 6ug/kg/min) at the time of study entry.|||percentage of participants who died|||Number
1259732|NCT00434993|Secondary|Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock|Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).|Determined 28 days after a subject entered the study|Patients with protocol defined shock (mean arterial pressure<60 or need for vasopressors except dopamine < 6ug/kg/min) at the time of study entry.|||days||Standard Error|Mean
1259733|NCT00434993|Secondary|Hospital Mortality to Day 60 in the Subset of Participants With ARDS|Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2.|Determined 60 days after a subject entered the study|Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.|||percentage of participants who died|||Number
1259768|NCT00434759|Primary|Change From Baseline in Social Interaction Anxiety Scale (SIAS)|This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
1259734|NCT00434993|Secondary|Ventilator Free Days to Day 28 in the Subset of Participants With ARDS|Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result.|Determined 28 days after a subject entered the study|Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.|||days||Standard Error|Mean
1259735|NCT00434993|Secondary|Number of Organ Failure-free Days at Day 28 Following Randomization|Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL.|Daily from baseline to study day 28|Intent to treat.|||days||Standard Error|Mean
1259736|NCT00434993|Secondary|Number of ICU-free Days at 28 Days After Randomization|ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day.|Determined 28 days after a subject entered the study|Intent to treat.|||days||Standard Error|Mean
1259737|NCT00434993|Secondary|Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90|Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived.|Determined 90 days after a subject entered the study|Intent to treat.|||percentage of participants who died|||Number
1259738|NCT00434993|Secondary|Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60|Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived.|Determined 60 days after a subject entered the study|Intent to treat population.|||percentage of participants who died|||Number
1259739|NCT00434993|Primary|Number of Ventilator Free Days (VFD)|Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.|Determined 28 days after a subject entered the study|All the intent to treat patients were analyzed. Data was available on all subjects for the primary analysis only.|||days||Standard Error|Mean
1259740|NCT00434967|Secondary|To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study).||Baseline to 8 weeks|||||||
1259741|NCT00434967|Secondary|To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study).||Baseline to 8 weeks|||||||
1259742|NCT00434967|Secondary|To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP.||Baseline to 8 weeks|||||||
1259743|NCT00434967|Secondary|To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.||Baseline to 8 weeks|||||||
1259744|NCT00434967|Secondary|Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).||Baseline to 8 weeks|||||||
1259745|NCT00434967|Secondary|The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study|Controlled sitting SBP and sitting DBP are defined as having sitting SBP < 140 mmHg and sitting DBP < 90 mmHg at the end of the study|8 weeks||||participants|||Number
1259746|NCT00434967|Primary|Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)|Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.|8 weeks||||mm Hg||Standard Error|Least Squares Mean
1259747|NCT00434967|Primary|Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).|Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.|8 weeks||||mm Hg||Standard Error|Least Squares Mean
1259764|NCT00434759|Primary|Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)|The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
1259748|NCT00434954|Secondary|Patient Reported Outcomes: Quality of Life (SF-12)|SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores > 50 indicate an above-average health status.|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||scores on SF-12 scale||Standard Deviation|Mean
1259749|NCT00434954|Secondary|Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)|Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||scores on DTSQ scale||Standard Deviation|Mean
1259750|NCT00434954|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward|||kg/m^2||Standard Error|Least Squares Mean
1259751|NCT00434954|Secondary|Change in Body Weight|Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward|||kg||Standard Error|Least Squares Mean
1259752|NCT00434954|Primary|Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)|Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)|||Percentage of participants|||Number
1259753|NCT00434954|Secondary|Blood Lipid Levels|Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||mmol/L||Standard Deviation|Mean
1259754|NCT00434954|Secondary|7 Point Self-monitored Blood Glucose (SMBG) Profiles|7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||mg/dL||Standard Deviation|Mean
1259755|NCT00434954|Secondary|Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)|Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) [i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)|||Percentage of participants|||Number
1259756|NCT00434954|Secondary|Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)|Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%]|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)|||Percentage of participants|||Number
1259757|NCT00434954|Secondary|Percentage of Subjects Achieving HbA1c Target of < 7.0%|Percentage of subjects achieving HbA1c target of < 7.0% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 7.0% divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||Percentage of participants|||Number
1259758|NCT00434954|Secondary|Percentage of Subjects Achieving HbA1c Target of < 6.5%|Percentage of subjects achieving HbA1c target of < 6.5% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 6.5% divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||Percentage of participants|||Number
1259759|NCT00434954|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1259760|NCT00434876|Secondary|Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.|The amount of time spent awake after initially falling asleep and before final awakening (in minutes). None to a fewer minutes is better (than a higher number of minutes).|Baseline, and week 8||||minutes||Standard Deviation|Mean
1259761|NCT00434876|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"PSQI total score (range 0-21). A PSQI total score > 5 indicates insomnia, with higher scores denoting a decrease in sleep quality.~The PSQI global score assesses for the overall quality of sleep and is computed by adding the 7 component scale scores. This widely used 19-item self-rated scale evaluates the subjective quality of sleep over the last 4 weeks. The PSQI was administered at baseline, and weeks 4, and 9."|Baseline, weeks 4, and 9.||||units on a scale||Standard Deviation|Mean
1259769|NCT00434642|Secondary|Percentage of Patients Who Had at Least 1 Adverse Event||From randomization through July 19, 2013 (up to 6 years, 3 months)|Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.|||Percentage of participants|||Number
1259770|NCT00434642|Secondary|Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)|A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.|||Percentage of participants|||Number
1259771|NCT00434642|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|From randomization through July 19, 2013 (up to 6 years, 3 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).|||Months||95% Confidence Interval|Median
1259772|NCT00434642|Secondary|Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Subset of the intent-to-treat population: All patients randomized to treatment who achieved an objective response.|||Months||95% Confidence Interval|Median
1259773|NCT00434642|Secondary|Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).|||Percentage of participants|||Number
1259774|NCT00434642|Primary|Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).|||Months||95% Confidence Interval|Median
1259775|NCT00434590|Secondary|Chronic Rejection as Confirmed by Renal Biopsy at 12 Months||12 months|||||||
1259776|NCT00434590|Secondary|Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months||12 months|||||||
1259777|NCT00434590|Secondary|Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months||12 months|||||||
1259778|NCT00434590|Secondary|Serum Creatinine at 12 Months||12 months|||||||
1259779|NCT00434590|Secondary|Creatinine Clearance at 12 Months||12 months|||||||
1259780|NCT00434590|Primary|Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months|The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.|12 months|Study was terminated without analysis (small sample size).|||mL/min||Standard Deviation|Mean
1259781|NCT00434434|Secondary|Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge|FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge.|From baseline to Week 16|Modified ITT population|||ratio of FEV1||Full Range|Median
1259782|NCT00434434|Primary|Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)|The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.|From baseline to Week 16|Modified intent-to-treat (ITT) population|||concentration change||Full Range|Median
1259783|NCT00434421|Primary|Proportion of Participants Who Discontinue Study|Proportion of participants who discontinued study for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment)|Initial placebo dose to end of 2-week treatment course (maximum study dose)|Safety Population: All study participants who were initiated onto the initial placebo study|||Percentage of Participants|||Number
1259784|NCT00434356|Secondary|Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients|||participants|||Number
1259785|NCT00434356|Secondary|Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients|||participants|||Number
1259788|NCT00434356|Secondary|Serious Adverse Events (SAEs)|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator|30 days following the last administration of study treatment|Treated patients|||participants|||Number
1259789|NCT00434356|Primary|Best Response|The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.|From randomization until disease progression/recurrence (by patient)|Randomized patients with at least one scan available at baseline and post-baseline|||participants|||Number
1259790|NCT00434330|Other Pre-specified|Proportion of Participants Who Maintain Hemoglobin Within 9.5 to 13.0 g/dL Throughout the Trial|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 9.5 g/dL to 13.0 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population|||percentage of participants|||Number
1259791|NCT00434330|Other Pre-specified|Proportion of Participants Who Maintained Hemoglobin Within 10 to 12.5 g/dL Throughout the Trial|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 10 g/dL to 12.5 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population|||percentage of participants|||Number
1259792|NCT00434330|Other Pre-specified|Proportion of Participants With Hemoglobin Within 1.0 g/dL Below Baseline to 1.5 g/dL Above Baseline Throughout the Trial (Weeks 2-29)|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within 1 g/dL below to 1.5 g/dL above baseline) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population|||percentage of participants|||Number
1259793|NCT00434330|Primary|Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.|The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.|Baseline and Weeks 2-29|Modified intent-to-treat (mITT) population|||g/dL||Standard Deviation|Mean
1259794|NCT00434304|Secondary|Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52|Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants|||beats per minute (bpm)||Standard Deviation|Mean
1259795|NCT00434304|Secondary|Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52|Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1259796|NCT00434304|Secondary|Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52|Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants|||participants|||Number
1259797|NCT00434304|Secondary|Urinalysis Data|The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.|Screening, Week 16, and Week 52|Safety Population: Screening Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants|||participants|||Number
1259798|NCT00434304|Secondary|Change From Baseline in Red Blood Cell Count at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||tera per Liter (TI/L)||Standard Deviation|Mean
1259799|NCT00434304|Secondary|Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||giga per Liter (GI/L)||Standard Deviation|Mean
1259800|NCT00434304|Secondary|Change From Baseline in Hematocrit at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||proportion of 1 (SI)||Standard Deviation|Mean
1259801|NCT00434304|Secondary|Change From Baseline in Prolactin at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||micrograms per Liter (MCG/L)||Standard Deviation|Mean
1259928|NCT00433654|Secondary|Ventricular Pacing Capture Threshold|Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.|3 or 4 months post-implant||||Volts||Standard Deviation|Mean
1259802|NCT00434304|Secondary|Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||millimoles per Liter (MMOL/L)||Standard Deviation|Mean
1259803|NCT00434304|Secondary|Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||micromoles per Liter (UMOL/L)||Standard Deviation|Mean
1259804|NCT00434304|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||international units per Liter (IU/L)||Standard Deviation|Mean
1259805|NCT00434304|Secondary|Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||grams per Liter (G/L)||Standard Deviation|Mean
1259806|NCT00434304|Secondary|Percentage of Participants Who Remained in the Study on the Indicated Days|The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.|Days 0-364|FAS. Participants dropped out of the study each week.|||percentage of participants|||Number
1259807|NCT00434304|Secondary|Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale|"CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as very much improved or much improved."|Weeks 1-52|FAS. Participants dropped out of the study each week.|||participants|||Number
1259808|NCT00434304|Secondary|Summary of the Modified Hoehn & Yahr Criteria Stages|Hoehn & Yahr criteria were measured on an 8-point scale. 0: No signs of disease, 1: Unilateral disease, 1.5: Unilateral plus axial involvement, 2: Bilateral disease, 2.5: Mild bilateral disease, 3: Mild to moderate bilateral disease. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).|Screening-Week 52|FAS. Participants dropped out of the study each week.|||points on a scale|||Number
1259809|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percent change||Standard Deviation|Mean
1259810|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
1259811|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 0-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
1259812|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percent change||Standard Deviation|Mean
1259813|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
1259814|NCT00434304|Primary|Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites|Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.|Weeks 1-16|PK Population. Blood sampling was performed in all participants in the Fixed titration phase and Maintenance dose phase to measure trough concentration. The maintenance dose differs for individual participants.|||pg/mL||Standard Deviation|Mean
1259815|NCT00434304|Primary|Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.|Weeks 5-16|PK Population|||hours||90% Confidence Interval|Median
1259816|NCT00434304|Primary|Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.|Weeks 5-16|PK Population|||hours*pg/mL||95% Confidence Interval|Geometric Mean
1259817|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Weeks 0-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
1259818|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part I|The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percent change||Standard Deviation|Mean
1259819|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part I|The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
1259820|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part I|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Weeks 0-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
1259821|NCT00434304|Secondary|Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III|A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percentage of responders|||Number
1259822|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part III|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percent change||Standard Deviation|Mean
1259823|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part III|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
1259824|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part III|The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Weeks 0-52|Full Analysis Set (FAS): all participants who progressed to the treatment phase, excluding those who did not fulfill major registration criteria, those who had not received at least one dose of the investigational drug, and those whose measured data were not available after treatment initiation. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
1259825|NCT00434304|Primary|Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.|Weeks 5-16|Pharmacokinetic (PK) Population: participants who underwent blood sampling for PK research, excluding those who did not fulfill inclusion criteria and those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.|||picograms/milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
1259826|NCT00434278|Secondary|Change in Pulmonary Function as Measured by FEV1 and FVC|FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) were recorded at Day 0 (baseline) and Day 14. Change in FEV1 and FVC from baseline to Day 14 was reported as a percentage of values predicted for age, height, and race.|From baseline to Day 14|Randomized patients. Patients not included in this analysis did not meet ATS reproducibility criteria. Two patients in the placebo arm whose screening visit values did not meet ATS reproducibility criteria were randomized in error and completed the study.|||Percentage of predicted value||Standard Deviation|Mean
1259827|NCT00434278|Primary|Change in Distance Walked in the 6-minute Walk Test|Change in distance walked was defined as (distance walked in 6 minutes at baseline [Day 0]) − (distance walked in 6 minutes at Day 14) in meters.|From baseline to Day 14|Randomized patients. For placebo arm: 2 placebo patients who were randomized did not complete the study and therefore had no values to calculate change from baseline computation.|||Meters||Standard Deviation|Mean
1259857|NCT00434161|Secondary|Incidence Ulcerative Mucositis (WHO Grades 2, 3, and 4)|"The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally."|at Day 32|Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.|||participants|||Number
1259828|NCT00434252|Secondary|Number of Participants With Select Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Select adverse events included arterial thromboembolic events (any grade), bleeding other than pulmonary or central nervous system (CNS) bleeding (Grade >= 3), CNS bleeding (any grade), febrile neutropenia (any grade), hypertension (Grade >= 3), neutropenia (Grade >= 3), pulmonary bleeding (any grade) and wound dehiscence (Grade >= 3).~*All serious adverse events are listed in the Adverse Event Reporting section."|Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.|The Safety-evaluable population consisted of all patients who received at least one full or partial dose of any component of study treatment.|||participants|||Number
1259829|NCT00434252|Secondary|Twenty−Four Week Landmark Stable Disease|"As assessed by the investigator using RECIST and defined as the absence of disease progression for 24 weeks from the time of randomization.~The percentage of patients who did not experience disease progression or death at 24 weeks following randomization was estimated using Kaplan-Meier methodology. If no tumor assessments were performed after the baseline visit, the patient will be censored at the date of randomization plus 1 day."|24 weeks|Intent-to-treat (randomized) patients|||percentage of participants||95% Confidence Interval|Number
1259830|NCT00434252|Secondary|Six-month Landmark Survival Rate|Six-month Landmark Survival Rate was defined as the percentage of participants surviving at 6 months following randomization. Overall Survival was estimated using the Kaplan−Meier method.|6 months|Intent-to-treat (randomized) population|||percentage of participants||95% Confidence Interval|Number
1259831|NCT00434252|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial objective response to documented disease progression or death, whichever occurred first, assessed by the investigator using RECIST. Progressive disease was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Duration of response was estimated using the Kaplan-Meier method.|Up to 102 weeks|Intent-to-treat (randomized) population. Only patients with measurable disease who achieved a response (either partial or complete) were included in the analysis of duration of response|||months||95% Confidence Interval|Median
1259832|NCT00434252|Secondary|Percentage of Participants With an Objective Response|"Objective response was defined as a complete or partial response according to RECIST criteria as assessed by the investigator on two consecutive assessments conducted at least 4 weeks apart.~The 95% Confidence Interval (CI) was calculated using the normal approximation to the binomial distribution."|Up to 102 weeks|Randomized Patients with Measurable Disease at Baseline|||percentage of participants||95% Confidence Interval|Number
1259833|NCT00434252|Secondary|Number of Participants With Objective Response|Objective response was assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and was inclusive of complete and partial response determined on two consecutive investigator assessments conducted ≥ 4 weeks apart.|Up to 102 weeks|Intent-to-treat (randomized) population.|||participants|||Number
1259834|NCT00434252|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. Median OS was estimated using the Kaplan−Meier method. For patients without documentation of death, overall survival will be censored at the time of the last known contact.|Up to 102 weeks|Intent-to-treat (randomized) population|||months||95% Confidence Interval|Median
1259835|NCT00434252|Primary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan−Meier method.|From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.|Intent-to-treat (randomized) population. For patients without documentation of disease progression or death on study, PFS was censored at the time of the last tumor assessment.|||months||95% Confidence Interval|Median
1259836|NCT00434226|Secondary|Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients|||participants|||Number
1259837|NCT00434226|Secondary|Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients|||participants|||Number
1259838|NCT00434226|Secondary|Incidence of Grade ≥ 3 Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients|||participants|||Number
1259839|NCT00434226|Secondary|Serious Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients|||participants|||Number
1259840|NCT00434226|Primary|Best Response|The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.|From randomization until disease progression/recurrence|Randomized patients with at least one scan available at baseline and post-baseline|||participants|||Number
1259841|NCT00434213|Secondary|Contact Sensitization to Methylphenidate|Contact sensitization to methylphenidate through skin patch testing.|7 weeks|Safety population|||Participants|||Number
1259842|NCT00434213|Primary|Dermal Reactions|Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|7 weeks|Safety population|||Participants|||Number
1259883|NCT00434057|Secondary|Biopsy Ratio|Number of lesions bioopsied to melanomas detected|Within 120 days of Data Lock||2009-12-31|12/2009||||
1259843|NCT00434161|Secondary|Incidence of Second Primary Malignancies or Other Malignancies|All comparisons for the long-term safety endpoints were based on the combined palifermin group versus placebo (placebo over palifermin). Incidence of new or secondary malignancies by treatment group was provided (incidence of new or secondary malignancies at the follow-up visit – yes, no, no assessment –, and number of subjects with new or secondary malignancies, per type of malignancies). The long-term safety evaluations were summarized for the subgroups defined by the factors used for randomization using descriptive statistics.|During long-term follow up phase (maximum of 10 years)|total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.|||participants|||Number
1259844|NCT00434161|Secondary|Time Death or Disease Progression|For the analysis of time to disease progression, competing risks time-to-event analysis was used, since a subject destined to develop disease progression could die from unrelated causes before the disease progression event takes place. Kaplan-Meier survival estimates, with death due to other causes than progression considered as a competing risk, were provided: event rate at 3 month intervals, with 95% confidence interval, the number of subjects at risk at the beginning of the time period, and the number of events of interest.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.|||months||Inter-Quartile Range|Median
1259845|NCT00434161|Secondary|Progression Free Survival|Progression-free survival (PFS) is the length of time during and after the treatment during which the disease being treated does not get worse. In this study the event for Progression-free survival was death from all causes or disease progression. Time to each event was defined as the time elapsed between the date of the first dose of investigational product, and the date of the given event.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.|||Months||Inter-Quartile Range|Median
1259846|NCT00434161|Primary|Incidence of Cataract Development or Progression at Month 12.|Number of participants from the primary cataract subset showing an increase from baseline of >= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).|12 months|Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group.|||Participants|||Number
1259847|NCT00434161|Secondary|Overall Survival|Overall survival (OS) is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47|||Months||Inter-Quartile Range|Median
1259848|NCT00434161|Secondary|Incidence of Adverse Events and Laboratory Abnormalities|Incidence of Adverse Events CTCAE grade 3 or higher reported|at Day 32||||Participants|||Number
1259849|NCT00434161|Secondary|Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 12.|To study if the treatment has effected on the visual acuity from baseline to months 12, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).|Month 12|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.|||participants|||Number
1259850|NCT00434161|Secondary|Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 6|To study if the treatment has effected on the visual acuity from baseline to months 6, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).|Months 6|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.|||participants|||Number
1259929|NCT00433654|Secondary|Atrial Pacing Capture Threshold|Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.|3 or 4 months post-implant|Includes all subjects with data.|||Volts||Standard Deviation|Mean
1259851|NCT00434161|Secondary|Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 12.|"To study the change in cataract from baseline visit to months 12, regarding the three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each."|Months 12|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.|||units on a scale||Standard Deviation|Mean
1259852|NCT00434161|Secondary|Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 6.|"To study the change in cataract from baseline visit to months 6, three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale.~To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in theLOCS III score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each."|Months 6|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.|||units on a scale||Standard Deviation|Mean
1259853|NCT00434161|Secondary|Incidence of an Increase Posterior Subcapsular Cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO) at Month 6 and 12|"To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~For Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO): at month 6 and 12 adjusted difference of rate of cataract, Palifermin - Placebo were used and the confidence interval were calculated on the adjusted difference."|at Month 6 and Month 12|281 subjects participated in the acute phase study of those 101 subjects were eligible for the cataract assessment study, 22 placebo and 79 palifermin. Month 6: 69 completed (17/22 [77.3%] in the placebo, 52/79 [65.8%] in the palifermin. Month 12: 66 completed (14/22 [63.6%] in the placebo, 52/79 [65.8%] in the palifermin group.|||participants|||Number
1259854|NCT00434161|Secondary|Incidence of Cataract Development or Progression (Change of ≥0.3 in Lens Opacities Classification System III (LOCS III Score)) at Month 6.|Number of participants from the primary cataract subset showing an increase from baseline of >= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).|6 Months|Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group. Number of patients with non-missing values at Months 6; were 17 in the placebo group and 53 in the palifermin group.|||participants|||Number
1259855|NCT00434161|Secondary|The Area Under the Curve (AUC) Was Calculated From the Patient-reported Outcome Mouth and Throat Soreness (MTS) Score.|"The mean daily scores were calculated using the subject daily assessment of Patient-reported mouth and throat soreness (MTS) on the 5 point scale with higher values in MTS indicating a worse self assessed MTS. A 5-grade WHO scale (0, 1, 2, 3, or 4). 0=no findings or erythema only, 1=soreness present with or without erythema, 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The area under the curve were calculated at the time points; Day(D)-2, up to Day 32."|at Day 32||||units on a scale * days||Standard Deviation|Mean
1259856|NCT00434161|Secondary|Duration of Ulcerative Mucositis (WHO Grades 2, 3, and 4)|"The duration of ulcerative mucositis measured the number of days the participants had different WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally. Patients that did not have any ulcerative mucositis were given a value of 0 days."|at Day 32|Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.|||Days||Full Range|Mean
1259884|NCT00434057|Primary|Sensitivity and Specificity|Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.|Within 120 days of Data Lock|All participants with eligible and evaluable lesions were used in analysis of primary outcome measures|||Ratio * 100||95% Confidence Interval|Mean
1293199|NCT00100698|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure|18 months||||mm Hg||Standard Error|Mean
1259858|NCT00434161|Primary|Maximum Severity of Oral Mucositis (World Health Organization (WHO) Grades 0/1, 2, 3, or 4)|"For the primary efficacy endpoint maximum severity of Oral Mucositis (OM) was assessed, the number of participants who had the different severity. To assess severity of OM, a 5-grade WHO scale (0, 1, 2, 3, or 4) was used.~0 = no findings or erythema only, 1= soreness present with or without erythema, 2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally."|at Day 32|Full analysis set that includes all randomized subjects, and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.|||Participants|||Number
1259859|NCT00434148|Secondary|Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score|A Cushing's syndrome health related quality of life (HRQL) questionnaire was completed. The Cushing’s Syndrome HRQL questionnaire contains 12 sentences with 5 possible answers each. The answers are based on Likert scales, with 5 response categories: Always, Often, Sometimes, Rarely and Never; or Very much, Quite a bit, Somewhat, Very little, and Not at all. The answers to each of the items are rated on a scale of 1 to 5. “1” corresponds to the response category “Always” or “Very much” and “5” corresponds to the category “Never” or “Not at all”. The score is the sum of all item responses and can range from 12 to 60 points. The lower the score, the greater the Cushing's Syndrome impacts on HRQoL. A positive change from baseline indicates improvement.|baseline, 3 months, 6 months, 12 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percentage change in HRQL score||Standard Deviation|Mean
1259860|NCT00434148|Secondary|Change From Baseline in Tumor Volume|Pituitary magnetic resonance imaging (MRI) was performed to determine tumor volume. A negative change from baseline indicates imrpovement.|baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||cm^3||Standard Deviation|Mean
1259861|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition|Body composition as in percentage of body fat by region was assessed by total body scan. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percentage of body fat||Standard Deviation|Mean
1259862|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD)|BMD was measured using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L1-L4), proximal femur (total hip) and proximal femur (femur neck). A negative change from baseline indicates imrpovement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||mg/cm^3||Standard Deviation|Mean
1259863|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score|The Ferriman Gallwey scoring system is used to score the degree of excess male pattern body hair. The scorecard of every body location under survey begins from 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth) and the numbers are added up to a maximum count of 36. A score >= 6 indicates the hirsutism. A negative change from baseline indicates imrpovement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60||||score on a scale||Standard Deviation|Mean
1259864|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score|"The BDI-II is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The scores range as follows:~0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. A negative change from baseline indicates imrpovement."|baseline, month 3, month 6, month 12, month 18, month 24|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||score on a scale||Standard Deviation|Mean
1259865|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides|Blood samples were drawn to obtain total cholesterol and triglycerides' levels. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||mmol/L||Standard Deviation|Mean
1259866|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference|Waist circumference was measured with a measuring tape correctly positioned. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||cm||Standard Deviation|Mean
1259896|NCT00433966|Secondary|Pharmacology Arm - Major Adverse Cardiovascular Events|Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)|30 days||||Participants|||Count of Participants
1259897|NCT00433966|Primary|Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis|Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis|1 year||||Participants|||Count of Participants
1259867|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)|BMI was determined by using height and weight measurements. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||kg/m^2||Standard Deviation|Mean
1259868|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)|Sitting blood pressure assessments were performed at every study visit. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1259869|NCT00434148|Secondary|Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)|Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement.|baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||percent change||Standard Deviation|Mean
1259870|NCT00434148|Secondary|Percent Change From Baseline in Serum Cortisol|Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement.|baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
1259871|NCT00434148|Secondary|Time to First UFC Response|Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response.|12 months|Full Analysis Set (FAS): The full analysis set included all randomized participants who received at least one dose of study drug.|||months||Inter-Quartile Range|Median
1259872|NCT00434148|Secondary|Change From Baseline in mUFC|Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement.|baseline, 3 months, 12 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||nmol/24h||Standard Deviation|Mean
1259873|NCT00434148|Primary|Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group|A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.|6 months|The full analysis set (FAS) was the primary population for efficacy and consisted of all 162 randomized patients who received at least one dose of paseriotide.|||Responders||95% Confidence Interval|Number
1259874|NCT00434122|Secondary|Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)|An adequate secretory endometrium 7 days after hCG injection was defined as secretory in the histological classification and with endometrial dating corresponding to the expected cycle day ±1 day.|7 days after hCG injection|Subjects with evaluable endometrial biopsies 7 days after injection with hCG.|||Participants|||Number
1259875|NCT00434122|Primary|Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)|"Explanation of the term coefficient of variation: The coefficient of variation is a normalized measure of dispersion of a probability distribution."|Stimulation Day 1||||Percentage||Standard Deviation|Mean
1259876|NCT00434109|Secondary|Percentage of Participants With Overall Survival (OS) at 4 Years|Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.|48 months|All Participants|||percentage of participants||95% Confidence Interval|Number
1259877|NCT00434109|Secondary|Number of Participants Requiring Dose Reduction|Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.|12 months|All participants|||participants|||Number
1259878|NCT00434109|Secondary|Number of Participants With Biochemical Response|Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.|12 months|All Participants|||participants|||Number
1259879|NCT00434109|Secondary|Number of Participants With Partial Radiographic Response|Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD.|12 months|All Participants|||participants|||Number
1259880|NCT00434109|Secondary|Percentage of Participants With Overall Survival (OS) at One Year|Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.|12 months|All participants|||percentage of participants||95% Confidence Interval|Number
1259881|NCT00434109|Primary|Percentage of Participants With Progression Free Survival (PFS) at 12 Months|Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started.|12 months|All participants|||percentage of participants||95% Confidence Interval|Number
1259882|NCT00434057|Secondary|Exploratory Analyses||Within 365 days of Data Lock||2010-02-28|02/2010||||
1259885|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Economic Self-Sufficiency subscale measures the ability to sustain customary socio-economic activity and independence.|long term (1 year)||||units on a scale||Standard Deviation|Mean
1259886|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Social Integration Subscale measures the ability to participate in and maintain customary social relationships.|long term (1 year)||||units on a scale||Standard Deviation|Mean
1259887|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Occupation Subscale measures the ability to occupy time in the manner customary to that person's sex, age, and culture.|long term (1 year)||||units on a scale||Standard Deviation|Mean
1259888|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Mobility Subscale measures the ability to move about effectively in his/her surroundings.|long term (1 year)||||units on a scale||Standard Deviation|Mean
1259889|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Physical Independence subscale measures the ability to sustain a customarily effective independent existence.|long term (1 year)||||units on a scale||Standard Deviation|Mean
1259890|NCT00434018|Primary|Wheelchair Skills Test (WST)|The WST is a standardized evaluation method that permits a set of representative wheelchair skills to be objectively, simply and inexpensively documented. The WST is an instrument for the objective evaluation of wheelchair skills. The WST consists of a series of commonly used wheelchair skills spanning the spectrum from those as basic as applying brakes to those as difficult as climbing curbs and performing wheelies. The WSC encompasses 57 skills (in Version 4.1) which result in a total score. The WST provide a pass-fail score for each skill. Refusal to attempt a skill (e.g. because of fear) constitutes a failing grade. The numerator is the Total Raw Score (i.e., the number of individual skills awarded a passing score) and the denominator is the number of applicable skills (i.e., the total number of skills minus those awarded NP scores). 100% is the maximum possible percentage score.|long term (1 year)||||units on a scale||Standard Deviation|Mean
1259891|NCT00433992|Secondary|Change in Fat Apoptosis|Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry|Entry, Week 48||||g||Inter-Quartile Range|Median
1259892|NCT00433992|Primary|Change in Mitochondrial Activity|mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.|Entry, Week 96||||copies/cell||Inter-Quartile Range|Median
1259893|NCT00433966|Secondary|Pharmacology Arm - Major Adverse Cardiovascular Events|Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)|3 years||||Participants|||Count of Participants
1259894|NCT00433966|Secondary|Stent Arm - Segment Binary Angiographic Restenosis|Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).|13 months||||Participants|||Count of Participants
1259895|NCT00433966|Secondary|Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding|Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)|30 days||||Participants|||Count of Participants
1259899|NCT00433966|Primary|Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events|Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).|30 Days||||Participants|||Count of Participants
1259900|NCT00433914|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set, i.e. all subjects in the exposed population who provided post-baseline safety data.|||Number of subjects|||Number
1259901|NCT00433914|Secondary|Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|One month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||Percentage of subjects||95% Confidence Interval|Number
1259902|NCT00433914|Secondary|Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||µg/mL||95% Confidence Interval|Geometric Mean
1259903|NCT00433914|Secondary|Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1259904|NCT00433914|Secondary|Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|One month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||Percentage of subjects||95% Confidence Interval|Number
1259905|NCT00433914|Primary|Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||Percentage of subjects||95% Confidence Interval|Number
1259906|NCT00433914|Primary|Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis.|||Percentage of subjects||95% Confidence Interval|Number
1259907|NCT00433836|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients|The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients.|Baseline and Week 8|A subset of approximately 100 - 150 patients from selected centers was expected to undergo Ambulatory Blood Pressure Monitoring at baseline (Week 0) and at Week 8; however, only 56 patients chose to participate in this aspect of the study.|||mm Hg||Standard Deviation|Mean
1259908|NCT00433836|Secondary|Decrease in MSSBP to < 95th Percentile for Age, Gender and Height|The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.|at week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.|||Percentage of participants|||Number
1259909|NCT00433836|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.|Baseline and Week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.|||mm Hg||Standard Error|Least Squares Mean
1259910|NCT00433836|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.|Baseline and Week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.|||mm Hg||Standard Error|Least Squares Mean
1259911|NCT00433771|Secondary|Number of Device-Related Adverse Events|Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.|Until 6 months or death|The intent-to-treat cohort of 58 patients was used for this analysis. Of all the events reported for this population, only 6 events were reported as device-related.|||Events|||Number
1259912|NCT00433771|Secondary|Time to Stent Occlusion|Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.|Until 6 Months or death|Only 1 subject experienced stent occlusion during the study.|||Days|||Number
1259913|NCT00433771|Secondary|Stent Patency at 6 Months|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).|6 Months|23 patients reached the Month 6 follow up point and were evaluated for stent patency.|||Participants|||Number
1259914|NCT00433771|Secondary|Stent Patency at 3 Months|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).|3 Months|34 patients reached the Month 3 follow up point and were evaluated for stent patency.|||Participants|||Number
1259915|NCT00433771|Secondary|Stent Patency at 1 Month|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.|1 month|45 out of 55 evaluable patients had both bilirubin and obstructive symptom assessment at Month 1.|||Participants|||Number
1259916|NCT00433771|Secondary|Bilirubin Level Reduction|Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.|1 month|45 out of 55 evaluable patients reported a baseline and a Month 1 total bilirubin level and were therefore analyzed for bilirubin levels reduction.|||Participants|||Number
1259917|NCT00433771|Secondary|Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.|6 months|23 out of 55 evaluable subjects reached the 6-Month follow up visit and were assessed for reduction of biliary obstructive symptoms compared to baseline.|||Participants|||Number
1259918|NCT00433771|Secondary|Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.|3 months|34 out of 55 evaluable subjects reached the 3-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms compared to baseline.|||Participants|||Number
1259919|NCT00433771|Secondary|Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.|1 Month|49 out of 55 evaluable subjects reached the 1-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms.|||Participants|||Number
1259920|NCT00433771|Secondary|Re-interventions|Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.|Until 6 months or death|The re-intervention rate was assessed in the evaluable cohort of 55 patients.|||Participant|||Number
1259921|NCT00433771|Secondary|Ability to Successfully Remove a Stent Upon Removal Attempt|The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.|6 months|2 patients of the evaluable cohort (n=55) were assessed for success of stent removal without any complications/technical difficulties.|||Participants|||Number
1259922|NCT00433771|Secondary|Technical Success|Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.|At treatment|Device Safety and Technical Success were evaluated for the 58 intent-to-treat patients|||participants|||Number
1259923|NCT00433771|Primary|Adequate Clinical Palliation of the Biliary Obstruction|Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.|6 months|Per protocol, assessment of the primary endpoint was performed on the evaluable cohort, defined as group of patients who signed the Informed Consent Form, met eligibility criteria, received a stent and had at least one week of follow up.|||participants|||Number
1259924|NCT00433745|Secondary|Disease Response|Clinical response of underlying malignancy to the vaccination|7 weeks after last dose of vaccine||||participants|||Number
1260421|NCT00430508|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Last Observation Carried Forward.|||mm Hg||Standard Deviation|Mean
1259930|NCT00433654|Secondary|Ventricular Lead Handling Rating|Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.|During implant|All surveys completed are included|||Units on a scale||Standard Deviation|Mean
1259931|NCT00433654|Secondary|Atrial Lead Handling Rating|Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.|During implant|All surveys completed are included|||Units on a scale||Standard Deviation|Mean
1259932|NCT00433654|Secondary|Ventricular Lead Impedance Change|Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.|9-12 week visit and 4-month visit|Subjects with non-missing data are included|||ohms||Standard Deviation|Mean
1259933|NCT00433654|Secondary|Atrial Lead Impedance Change|Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.|9-12 week visit and 4-month visit|Subjects with non-missing data are included|||ohms||Standard Deviation|Mean
1259934|NCT00433654|Secondary|Occurrence of Arrhythmias|Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan|During the MRI scan|Arrhythmia was defined as heart rate > 150 beats per minute for > 30 seconds. Asystole was defined as standstill 6 seconds in electrical activity of the heart. Episodes were assessed via pulse oximetry monitoring during MRI scans.|||participants|||Number
1259935|NCT00433654|Secondary|System Related Adverse Device Effects Due to Labeling Instructions|Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.|Implant through 18 months post-implant|Includes all subjects undergoing an MRI using the instructions in the protocol.|||participants|||Number
1259936|NCT00433654|Secondary|Subjects With System-related Complications|Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.|Implant to 4 Months|All implanted subjects with either a 4-month follow-up or a system-related complication within the first 4 months post-implant are included.|||participants|||Number
1259937|NCT00433654|Primary|Ventricular Sensed Amplitude Success|Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have ventricular sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week ventricular sensed amplitude was less than 5.0 mV.|||participants|||Number
1259938|NCT00433654|Primary|Atrial Sensed Amplitude Success|Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have atrial sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week atrial sensed amplitude was less than 1.5 mV.|||participants|||Number
1259939|NCT00433654|Primary|Ventricular Pacing Capture Threshold Success|Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have ventricular pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.|||participants|||Number
1259940|NCT00433654|Primary|Atrial Pacing Capture Threshold Success|Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have atrial pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.|||participants|||Number
1259941|NCT00433654|Primary|Magnetic Resonance Imaging (MRI)-Related Complications|Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.|MRI scan to one-month post-MRI scan|Subjects who underwent an MRI scan following study protocol-specified instructions are included. Of the 243 subjects who completed a one-month post-MRI (4-month) visit, 32 did not complete the MRI scan according to the protocol instructions, and are not included.|||participants|||Number
1284702|NCT00201240|Secondary|Chronic Graft Versus Host Disease (GVHD)|Incidence and severity of chronic GVHD will be scored according to the BMT CTN MOP.|Year 2||||percentage of participants||95% Confidence Interval|Number
1259942|NCT00433550|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.|||months||95% Confidence Interval|Median
1259943|NCT00433550|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.|Up to 2 years|All patients who achieved a CR or PR are included in this analysis.|||months||95% Confidence Interval|Median
1259944|NCT00433550|Secondary|Progression Free Survival|Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The distribution of time to progression will be estimated using Kaplan-Meier methodology.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.|||months||95% Confidence Interval|Median
1259945|NCT00433550|Secondary|Overall Survival|Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.|||months||95% Confidence Interval|Median
1259946|NCT00433550|Primary|Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)|Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|36 weeks|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.|||proportion of patients||95% Confidence Interval|Number
1259947|NCT00433537|Secondary|3-year Overall Survival (OS)|OS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to death. Patients alive at last follow-up were censored.|Assessed every 6 months for 5 years, and then yearly thereafter.|Eligible and treated patients who received maintenance rituximab or ASCT|||probability||95% Confidence Interval|Number
1259948|NCT00433537|Secondary|2-year Progression-free Survival (PFS)|PFS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 6 months for 5 years, and then yearly thereafter.|Eligible and treated patients who received maintenance rituximab or ASCT|||probability||95% Confidence Interval|Number
1259949|NCT00433537|Primary|Complete Response (CR) Rate|Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.|Assessed after VcR-CVAD cycles 2, 4, and 6.|Eligible and treated patients|||proportion||95% Confidence Interval|Number
1259950|NCT00433446|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1259951|NCT00433446|Secondary|Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. PSA = .2 ng/ml. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.|Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression|All eligible patients with measurable disease who started treatment were included in the analysis|||participants|||Number
1259952|NCT00433446|Secondary|Overall Survival (OS)|Measured from date of registration to date of death due to any cause or last contact|0-3 yeas after registration|All eligible patients who started treatment were included in the analysis|||months||95% Confidence Interval|Median
1259953|NCT00433446|Primary|Confirmed Prostate-Specific Antigen (PSA) Response|PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.|Assessed every 3 cycles (1 cycle = 14 days) until progression|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1260530|NCT00429364|Secondary|Annual Rate of Change in Body Mass Index for Age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose body mass index for age z-scores were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
1259954|NCT00433446|Secondary|Progression-free Survival (PFS)|PFS is defined as tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, PSA progression by PSA Working Group criteria, or symptomatic deterioration.|Assessed every 3 cycles (1 cycle = 14 days) until progression|All eligible patients who started treatment were included in the analysis|||months||95% Confidence Interval|Median
1259955|NCT00433381|Secondary|Change in Perfusion MRI Markers at Week 16 as Predictors of 12mo Overall Survival (OS)|To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 16 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 16 are the prognostic indicators.|Baseline and 16 Weeks|Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention|||Area Under the Curve (AUC)||95% Confidence Interval|Number
1259956|NCT00433381|Secondary|Change in Perfusion MRI Markers at Week 8 as Predictors of 12mo Overall Survival (OS)|To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 8 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 8 are the prognostic indicators.|Baseline and 8 weeks|Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention|||Area Under the Curve (AUC)||95% Confidence Interval|Number
1259957|NCT00433381|Secondary|Change in Perfusion MRI Markers at Week 2 as Predictors of 12mo Overall Survival (OS)|To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 2 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 2 are the prognostic indicators.|Baseline and 2 Weeks|Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention|||Area Under the Curve (AUC)||95% Confidence Interval|Number
1259958|NCT00433381|Secondary|Predictive Value of CBV and Lac/NAA in Assessing 6-month Progression-free Survival|Aim not included in final (February 10, 2009) protocol (removed from section 2)|2 weeks following initiation of protocol treatment (T1)|This Aim was removed from the approved protocol aims. Data were not collected.||||||
1259959|NCT00433381|Secondary|Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to Patient Response|Aim not included in final (February 10, 2009) protocol (removed from section 2)|2 weeks following initiation of protocol treatment (T1)|This Aim was removed from the approved protocol aims. Data were not collected.||||||
1259960|NCT00433381|Secondary|Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to N-acetylaspartate (NAA) (Lac/NAA) Ratio|Aim not included in final (February 10, 2009) protocol (removed from section 2).|2 weeks following initiation of protocol treatment (T1) and at 8 weeks following chemotherapy with bevacizumab (T2)|This Aim was removed from the approved protocol aims. Data were not collected.||||||
1259961|NCT00433381|Secondary|Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard|Local reads were treated as the test and central reads were treated as the reference standard. Thus, a participant meeting the definition of progression on any standard MRI central interpretation (baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment) was considered positive for PFS-6. Therefore, a true positive is defined as a positive local interpretation for a subject with a positive central read.|baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment|Standard of care MRI occurred at baseline, after every 2 cycles of treatment (every 8 weeks), and after completion/termination of treatment. Subjects participated in the MR substudies regardless of therapeutic intervention|||Participants|||Count of Participants
1259962|NCT00433381|Secondary|Agreement Between Local Interpretation and Central Interpretation of Standard MRI|Local and central interpretations of the standard MRI were assessed for progression and survival at all available imaging (baseline visit, week 2, and after every 2 cycles of treatment, and at termination of treatment). Patients who suffer clinical progression without radiographic confirmation of progression were considered to have progressive disease in determination of PFS-6. Subjects participated in the MR substudies regardless of therapeutic intervention|baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment|Of the 123 subject accrued to ACRIN 6677, 103 were analyzable for this aim. Reasons for exclusions were as follows: 11 subjects only had baseline imaging, 4 were ineligible, 1 was lost to followup, and 4 had incomplete/uninterpretable images.|||Participants|||Count of Participants
1259963|NCT00433381|Secondary|Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression)|Tumor size measured in millimeters and is the largest crosssectional area using perpendicular measurements of contrast enhancing abnormality. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off corticosteroids, and neurologically stable or improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive MRI scans at least 1 month apart, corticosteroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Stable disease (SD): Does not qualify for CR, PR, or PD.|From randomization to death or last follow-up. Patients were followed up to 62.9 months.|Eligible patients with measurable disease at baseline|||Participants|||Count of Participants
1259979|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259964|NCT00433381|Secondary|Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Temozolomide Arm|Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.|From randomization to six months.|Eligible patients with six-month data.|||Participants|||Count of Participants
1259965|NCT00433381|Primary|Number of Participants With Predicted Overall Survival (OS) at 12 Months|"Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 12-month overall survival (OS).~Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to death, evaluated at 96wks, is the determinate of OS at 12 months. Subjects will not be analyzed by arm."|2 and 8 weeks posttreatment, and every 2 months until 96wks|A subset of 3 institutions conducted a substudy of advanced MRI, including dynamic contrast enhanced imaging, dynamic susceptibility contrast imaging, and MRSI. Subjects participated in the MR substudies regardless of therapeutic intervention|||Participants|||Count of Participants
1259966|NCT00433381|Primary|Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6)|Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 6-month progression-free survival (PFS-6) over all study participants. Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to progression, evaluated at 96wks, is the determinate of PFS at 6months (PFS-6). Subjects will not be analyzed by arm.|2 and 8 weeks posttreatment, and every 2 months until 96wks|"A subset of 3 institutions conducted a substudy of advanced MRI, including dynamic contrast enhanced imaging, dynamic susceptibility contrast imaging, and MRSI.~Of 123 main subjects, a subset of 20 consented to the MRS substudy, of whom 13 had analyzable MRS datasets. this subset is independent of Study Arm."|||Participants|||Count of Participants
1259967|NCT00433381|Primary|Count/Percentage of Patients Discontinuing Treatment Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm)|This endpoint determines tolerability of this treatment arm. If tolerable, then the secondary endpoint of treatment efficacy for this arm occurs. Percentage is calculated by taking the number of patients who did not stop bevacizumab and temozolomide treatment due to medical complications in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who did not begin treatment.|From randomization to end of treatment (treatment can continue up to 24 months for patients with stable or responding tumor).|The first 29 eligible patients who received protocol treatment were to be evaluated for treatment tolerability.|||Participants|||Count of Participants
1259968|NCT00433381|Primary|Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Irinotecan Hydrochloride Arm|Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.|From randomization to six months.|Eligible patients with six-month data.|||Participants|||Count of Participants
1259969|NCT00433329|Primary|Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters|The 6MWT is a non encouraged test, which measures the walking distance covered over a 6 minute period|at 16 weeks and at 28 weeks of a stepped approach to therapy|Intention to treat population|||participants||95% Confidence Interval|Number
1259970|NCT00433290|Secondary|Adverse Events Reported as Reason for Discontinuation in Nonresponders|Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.|over 13 Weeks|Number of randomized participants who were nonresponders at Visit 4 (7 weeks).|||participants|||Number
1259971|NCT00433290|Secondary|Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint|Response was defined as a >=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a <30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score.|13 Weeks|Number of randomized participants who were non-responders at Visit 4 (7 weeks) and with non-missing response values.|||participants|||Number
1259972|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders|"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).~Non-Responders were defined as patients with a <30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score."|Baseline and 13 Weeks|Number of participants who did not respond to treatment after 6 weeks of treatment.|||units on a scale||Standard Deviation|Mean
1259973|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Weight||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.|||kilograms||Standard Deviation|Mean
1259974|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.|||mm Hg||Standard Deviation|Mean
1259975|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.|||beats per minute||Standard Deviation|Mean
1259976|NCT00433290|Secondary|Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride||Baseline and 13 Week Endpoint|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||millimole per Liter||Standard Deviation|Mean
1259977|NCT00433290|Secondary|Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.|||Units/Liter||Standard Deviation|Mean
1259978|NCT00433290|Secondary|Adverse Events Reported as Reason for Discontinuation||over 13 weeks|All randomized participants.|||participants|||Number
1259980|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259981|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259982|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259983|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259984|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259985|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259986|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity|A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259987|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259988|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259989|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259990|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259991|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)|A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259992|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline and 13 Weeks|All randomized participants. Intent-to-treat analysis.|||units on a scale||Standard Deviation|Mean
1259993|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire – 5 Dimension (EQ-5D)|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1260164|NCT00432458|Secondary|Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 2.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|During treatment (up to 5 years)||||participants|||Number
1259994|NCT00433290|Secondary|Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores|MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30.|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259995|NCT00433290|Secondary|Number of Participants Who Responded to Treatment at 13 Week Endpoint|Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|13 Weeks|Number of randomized participants with non-missing response values.|||participants|||Number
1259996|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259997|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores|This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline.|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259998|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).|Baseline and 13 Weeks|All randomized participants with baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1259999|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).|Baseline and 13 Weeks|All randomized participants with baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1260000|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1260001|NCT00433290|Secondary|Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|13 Weeks|All randomized participants with at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
1260002|NCT00433290|Primary|Change in Brief Pain Inventory (BPI) 24-hour Average Rating|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline.|Baseline, Week 4, Week 7, Week 13|All randomized participants. Intent-to-treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1260003|NCT00433199|Secondary|Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.|The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.|Day 364|The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364.|||Percentage of subjects||95% Confidence Interval|Number
1260004|NCT00433199|Secondary|Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.|The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.|Day 266|The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266.|||Percentage of subjects||95% Confidence Interval|Number
1260005|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.|Day 182|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182.|||Percentage of subjects||95% Confidence Interval|Number
1260006|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results|Day 56|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56.|||Percentage of subjects||95% Confidence Interval|Number
1260007|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results|Day 14|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14.|||Percentage of subjects||95% Confidence Interval|Number
1260008|NCT00433199|Primary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112|Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results|Day 112|The analysis was done on the Full analysis sample defined as the subjects who were included in the Safety Sample and who had data for at least one post-Baseline assessment of any efficacy measurement up to and including Day 182 (double-blind period). The number correspond to the number of subjects having a measurement at Day 112;|||Percentage of subjects||95% Confidence Interval|Number
1260009|NCT00433160|Secondary|Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks|Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement.|||participants|||Number
1260010|NCT00433160|Secondary|Fractures by Investigators Assessment During Entire Study Period of 104 Weeks|"Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma."|Baseline Through 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||number of fractures|||Number
1260011|NCT00433160|Secondary|Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks|Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.|Baseline through 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. The n's are the number of participants with fractures.|||number of fractures|||Number
1260012|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in CTX||Standard Deviation|Mean
1260013|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BAP||Standard Deviation|Mean
1260014|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.|||percent change in PINP||Standard Deviation|Mean
1260015|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density at femoral neck from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
1260016|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
1260017|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
1260018|NCT00433160|Secondary|Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
1260019|NCT00433160|Secondary|Back Pain Severity|Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).|Baseline, Weeks 12, 24, 36, 52|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||participants|||Number
1260114|NCT00432666|Secondary|Carer's Global Assessment of Efficacy|The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260020|NCT00433160|Secondary|Fractures by Investigators Assessment|"Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma."|Baseline through 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||number of fractures|||Number
1260021|NCT00433160|Secondary|Vertebral Fractures by Central X-ray Assessment|Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.|Baseline through 52 weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures.|||number of fractures|||Number
1260022|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism – Serum Type I Collagen Crosslinked C-telopeptide (CTX)|Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, 52|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in CTX||Standard Deviation|Mean
1260023|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)|Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, 52|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BAP||Standard Deviation|Mean
1260024|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)|Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, and 52|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.|||percent change in PINP||Standard Deviation|Mean
1260025|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Femoral Neck|Percent change in bone mineral density at femoral neck from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
1260026|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Total Hip|Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
1260027|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)|Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
1260028|NCT00433160|Primary|Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)|Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.|Baseline to 52 weeks|Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
1260029|NCT00433147|Secondary|Change From Baseline To End Of Treatment In Beta-glucocerebrosidase (GCase) Levels In White Blood Cells (WBC)|GCase is a biomarker used to assess the PD effects of afegostat tartrate. Blood samples were collected to assess GCase levels in WBC. The baseline value was defined as the last non-missing value before the start of study drug.|Baseline, Day 28|PD Population: All participants who were included in the Safety Population and had a baseline and at least 1 post-baseline PD measurement.|||pmol/mg/min||Standard Deviation|Mean
1260030|NCT00433147|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event (AE) with a start date on or after administration of the study drug (on Day 1). A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 through 7 days after the last dose of study drug (Day 35) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Day 35|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1260031|NCT00433017|Secondary|Mean Change in Central Retinal Thickness of the Study Eye at Month 12|Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness.|Baseline and Month 12|Full analysis set, LOCF|||μm||Standard Deviation|Mean
1260032|NCT00433017|Secondary|Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12|Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage.|Baseline and Month 12|Full analysis set based on observed data.|||mm^2||Standard Deviation|Mean
1260033|NCT00433017|Secondary|Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12|The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Month 12|The Full Analysis Set (FAS) based on observed data.|||Percentage of participants|||Number
1260034|NCT00433017|Primary|Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit|The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.|Month 2 to Month 11|Full analysis set. Includes number of participants in the treatment group with at least one visit assessment of re-treatment.|||Percentage of Participants|||Number
1260155|NCT00432562|Primary|Last Quantifiable Drug Concentration (Clast)||0-144 hours post-dose||||ng/mL||Standard Deviation|Mean
1260035|NCT00433017|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 12|Performed on the Full analysis set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. FAS consisted of all patients as randomized that received at least one application of study drug and had at least one post-baseline assessment for best corrected visual acuity in the study eye.|||Letters||Standard Deviation|Mean
1260036|NCT00433004|Primary|PLAN B USE||1 year||||Participants|||Count of Participants
1260037|NCT00433004|Primary|PREGNANCY RATES||1 year||||Participants|||Count of Participants
1260038|NCT00433004|Primary|ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.||1 year||||Participants|||Count of Participants
1260039|NCT00432991|Primary|Post-Operation Nausea Score|"Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea two times after the conclusion of their surgery: 1) upon arrival in the PACU, and 2) immediately prior to discharge from the PACU.~The numbers given by the subject were then averaged to determine the average level of nausea post-operative for each subject."|post-operation||||units on a scale||Standard Deviation|Mean
1260040|NCT00432991|Primary|Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea.|"Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea, five times during their procedure: 1) Immediately prior to skin incision, 2) immediately following delivery of the baby, 3) following reinternalization of the uterus, 4) following closure of the fascia, 5) following closure of the skin.~The numbers given by the subject were then averaged to determine the average level of nausea intra-operatively for each subject."|intra-operation||||units on a scale||Standard Deviation|Mean
1260041|NCT00432991|Primary|Pre-Induction Nausea Score|Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea|immediately pre-induction||||units on a scale||Standard Deviation|Mean
1260042|NCT00432965|Primary|Incidence of Complete Ulcer Closure Closure.||Days 0-114|Analysis of this endpoint was based on the Intent-to-Treat (ITT population). Subjects who signed an informed consent and were randomized, but failed to undergo their assigned randomized treatment, were included in this population.|||Participants|||Count of Participants
1260043|NCT00432835|Primary|Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis|Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.|Study Day 0 (Baseline), Day 4, Day 8||||percentage of radiolabeled meal in stoma||Standard Error|Mean
1260044|NCT00432835|Primary|Symptom of Nausea Associated With Gastroparesis|Likert Scale 0-4 (low-high) using a patient reported outcomes tool|Study Day 0 (Baseline), Day 3, Day 7||||Patient Self-reported Symptom Score||Standard Error|Mean
1260045|NCT00432835|Primary|Symptom of Vomiting Associated With Gastroparesis|Likert Scale 0-4 (low-high) using a patient reported outcomes tool|Study Day 0 (Baseline), Day 3, Day 7||||Patient Self-reported Symptom Score||Standard Error|Mean
1260046|NCT00432809|Secondary|Cardiovascular Medications - Anticoagulants|Number of participants taking anticoagulants at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260047|NCT00432809|Secondary|Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)|Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260048|NCT00432809|Secondary|Cardiovascular Medications - Beta Blocker|Number of participants taking Beta Blockers at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260049|NCT00432809|Secondary|Cardiovascular Medications - Lipid Lowering Agents|Number of participants taking Lipid lowering agents at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260050|NCT00432809|Secondary|Diabetes Medication - Use of Secretagogue|Number of participants taking Secretagogues at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260051|NCT00432809|Secondary|Diabetes Medication - Use of Incretin Mimetics|Number of participants taking Incretin Mimetics|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260156|NCT00432562|Primary|Time of Last Measurable Concentration (Tlast)||0-144 hours post-dose||||hours||Standard Deviation|Mean
1260157|NCT00432562|Primary|Observed Terminal Elimination Half-Life (t1/2)|t1/2 = [ln(2)/λ z]|0-144 hours post-dose||||hours||Standard Deviation|Mean
1260052|NCT00432809|Secondary|Diabetes Medication - Use of Thiazolidinedione|Number of participants using thiazolidinedione at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260053|NCT00432809|Secondary|Diabetes Medication - Use of Biguanides|Number of participants taking Biguanides at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260054|NCT00432809|Secondary|Diabetes Medication - Use of Insulin|Number of participants taking insulin at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260055|NCT00432809|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)|Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mg/L||Inter-Quartile Range|Median
1260056|NCT00432809|Secondary|Change in Triglycerides|Median percent change in triglycerides at 12 months from baseline measure|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mg/dL||Inter-Quartile Range|Median
1260057|NCT00432809|Secondary|Change in High-density Lipoprotein (HDL)|Percent change in high-density lipoprotein (HDL) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mg/dL||Standard Deviation|Mean
1260058|NCT00432809|Secondary|Change in Systolic Blood Pressure (SBP)|Change in Systolic Blood Pressure (SBP) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mm Hg||Standard Deviation|Mean
1260059|NCT00432809|Secondary|Change in Body Mass Index (BMI)|Change in Body Mass Index (BMI) at 12 months, measured in kg/m2|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||kg/m2||Standard Deviation|Mean
1260060|NCT00432809|Secondary|Body Mass Index (BMI)|Body Mass Index (BMI) at 12 months measured as kg/m2|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||kg/m2||Standard Deviation|Mean
1260061|NCT00432809|Secondary|Change in Body Weight From Baseline|Mean change in body weight from baseline measured in kilograms (kg)|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||kg||Standard Deviation|Mean
1260062|NCT00432809|Secondary|Body Weight|Body weight in kilograms (kg) measured at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||kg||Standard Deviation|Mean
1260063|NCT00432809|Primary|Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications|The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260064|NCT00432809|Secondary|Glycated Hemoglobin (HbA1c)|Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||percentage points of glycated hemoglobin||Standard Deviation|Mean
1260065|NCT00432809|Secondary|Fasting Plasma Glucose|Fasting Plasma Glucose measured in mg/dL.|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mg/dL||Inter-Quartile Range|Median
1260158|NCT00432562|Primary|Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)|Estimated via linear regression of the time versus log concentration|0-144 hours post-dose||||hr-1||Standard Deviation|Mean
1260066|NCT00432809|Secondary|Change in Glycated Hemoglobin (HbA1c)|Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change|1 year - baseline|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||percentage points of glycated hemoglobin||Standard Deviation|Mean
1260067|NCT00432809|Secondary|The Cost-effectiveness of Each Program and the Side Effects and /or Complications.||1, 2, and 5 years.|||||||
1260068|NCT00432809|Secondary|Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.||1, 2, and 5 years|||||||
1260069|NCT00432809|Secondary|Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).||1, 2, and 5 years|||||||
1260070|NCT00432809|Primary|Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.|The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).|1 year|Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
1260071|NCT00432744|Primary|Non-parametric Hotelling T-square Bivariate Analysis of GMGF 88 and OPeds QOL.|This is a multivariate analysis of the first two outcomes: Period 2 minus Period 1 GMFM88 and Peds Quality of Life, analyzed as follows: First, to be in the analysis, subjects must contribute at least one of these endpoints. Second, if the subject became totally disabled during period 1, the difference was defined as + infinity, (highest possible evidence favoring period 2), and if the subject became totally disabled in period 2, the subject was scored as - infinity (highest possible evidence favoring period 1). Period 2 minus period 1 differences were ranked form low to high with missing values scores at the mid-rank. The Hotelling T-square was computed on these ranks and the P-value was obtained from 100,000 rerandomizations as the fraction of rerandomizations with T-sq at least as large as that observed.|end of 12 month minus end of 6 month difference.|Subjects contributes at least one difference (either GMFM or Peds QOL). Thirteen contributed both and one each was missing GMFM or Peds QOL.|||participants|||Number
1260072|NCT00432744|Primary|Pediatric Quality of Life Scale|"The Pediatric Quality of Life Scale is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. Goggle pedsQL and Mapi to browse the copyrighted manual. A link to the instrument is included."|At 6 and 12 Months|7 subjects in each group were evaluable for this endpoint. The two subjects who became disabled are evaluable. One subject did not have period 2 Quality of Life data and is excluded.|||units on a scale||Inter-Quartile Range|Median
1260073|NCT00432744|Primary|McMaster Gross Motor Function (GMFM 88)|The McMaster Gross Motor Function is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. One of the links in this report is to the the GMFM scale and how it is scored. A link to the instrument is included.|Taken at 6 and 12 Months||||units on a scale||Inter-Quartile Range|Median
1260074|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260075|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260076|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260077|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260078|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260079|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260080|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260081|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260082|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260083|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260084|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260085|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260086|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260087|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260088|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
1260089|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260090|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260091|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260092|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260093|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260094|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260095|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260096|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260097|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260098|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260099|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260100|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260101|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260102|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260103|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260104|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260105|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260106|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260107|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260108|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260109|NCT00432666|Secondary|Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260110|NCT00432666|Secondary|Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260111|NCT00432666|Secondary|Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260112|NCT00432666|Secondary|Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260113|NCT00432666|Secondary|Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260115|NCT00432666|Secondary|Patient's Global Assessment of Efficacy|The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260116|NCT00432666|Secondary|Investigator's Global Assessment of Efficacy|The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260117|NCT00432666|Other Pre-specified|Onset of Treatment Effect [Classified]|"Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed.~For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period."|Period starting at baseline injection of the Main Period up to onset of treatment effect|"These results are a different presentation of the results of the secondary outcome measure Time to Onset of Treatment Effect. For subjects without any treatment effect the time to onset of effect was censored at the last visit."|||Participants|||Number
1260118|NCT00432666|Secondary|Duration of Treatment Effect|The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero.|Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator||||Days||95% Confidence Interval|Median
1260119|NCT00432666|Secondary|Time to Waning of Treatment Effect|Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was “no”. If the patient answered with “yes” he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero.|Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect||||Weeks||95% Confidence Interval|Median
1260120|NCT00432666|Secondary|Time to Onset of Treatment Effect|"Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed.~For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period."|Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect|"Results for placebo patients were not displayed because the upper limit of the confidence interval was not estimable (this can not be entered because a numeric entry is expected). The results of this analysis are therefore given as Onset of Treatment Effect [classified] under Other Pre-specified Outcome."|||Days||95% Confidence Interval|Median
1260121|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260122|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260123|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260124|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260159|NCT00432562|Primary|Percentage of AUCinf Based on Extrapolation (AUCextrap)||0-144 hours post-dose||||% of participants||Standard Deviation|Mean
1260160|NCT00432562|Primary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)|AUCinf = AUClast + (Clast/lamda z)|0-144 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
1294141|NCT00094497|Primary|Overall Survival|participants who died among those randomized to first-line therapy|every 8 weeks until death up to 5 years||||participants|||Number
1260125|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260126|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260127|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260128|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260129|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260130|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260131|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260132|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260133|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260134|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260161|NCT00432562|Primary|Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)|Determined Using the Linear Trapezoidal Rule|0-144 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
1260162|NCT00432562|Primary|Maximum Observed Plasma Concentration (Cmax)||0-144 hours post-dose||||ng/mL||Standard Deviation|Mean
1260135|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260136|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260137|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260138|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260139|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260140|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260141|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260142|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260143|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260144|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260163|NCT00432562|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0-144 hours post dose||||hours||Standard Deviation|Mean
1284703|NCT00201240|Secondary|Acute Graft Versus Host Disease (GVHD)|Incidence and severity of acute GVHD will be graded according to the BMT CTN MOP.|Day 100||||percentage of participants||95% Confidence Interval|Number
1260145|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
1260146|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
1260147|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
1260148|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
1260149|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
1260150|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
1260151|NCT00432666|Secondary|Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
1260152|NCT00432666|Primary|Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were not imputed|||Participants|||Number
1260153|NCT00432601|Primary|Knowledge|Questions addressed the survival benefit and side effects associated with treatment options for localized prostate cancer.|Results visit (Time 2 - approximately 7-10 days after Time 1)||||percentage correct on a 12 item scale||Standard Error|Mean
1260154|NCT00432562|Primary|Mean Residence Time (MRTinf)|MRT = (AUMCinf)/(AUCinf)|0-144 hours post-dose||||hours||Standard Deviation|Mean
1260165|NCT00432458|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was defined as the time from randomization to the date at which the patient was removed from (protocol) treatment due to disease progression, unacceptable toxicity, participant refusal or death. The median TTF with 95% CI was estimated using the Kaplan Meier method|time from randomization to treatment failure (up to 5 years)||||months||95% Confidence Interval|Median
1260166|NCT00432458|Secondary|Time to Subsequent Treatment|Time to subsequent treatment (TTS) was defined as time from end of active (protocol) treatment to the start of subsequent treatment for participants with progressive disease. The median TTS with 95% CI was estimated using the Kaplan Meier method|time from end of treatment to subsequent treatment (up to 5 years)|This data was not (and will never be) analyzed as it was not submitted consistently across all participants.|||years||95% Confidence Interval|Median
1260167|NCT00432458|Secondary|Duration of Response (Complete Response, Partial Response, and Very Good Partial Response)|Duration of response (DOR) is defined as the time from first documentation of response (CR, VGPR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method|time from start of response to progression (up to 5 years)|Participants who achieved a confirmed response (CR, VGPR, or PR) as described above were analyzed.|||years||95% Confidence Interval|Median
1260168|NCT00432458|Secondary|Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment|"Response is defined as follows:~CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)~VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|12 months||||participants|||Number
1260169|NCT00432458|Secondary|12-month Progression-free Survival (PFS)|PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of randomization.|12 months||||participants|||Number
1260170|NCT00432458|Primary|Time to Disease Progression (TTP)|Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated.|randomization to progression (up to 5 years)|Time to disease progression was analyzed on all randomized participants on an intent to treat basis.|||years||95% Confidence Interval|Median
1260171|NCT00432445|Primary|Rate of Local Control in the Globe at 12 Months|Where proton beam radiation therapy used as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention, local tumor control measured for participants with a globe as tumor regression with ocular retention, and for post enucleation measured as lack of orbital tumor recurrence.|12 months|No analysis performed. Study did not meet anticipated enrollment.||||||
1260172|NCT00432380|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
1260173|NCT00432380|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 31-day (Days 0-30) period following any study vaccine dose or placebo|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
1260174|NCT00432380|Secondary|Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes|Presence of RV (vaccine strain or wild-type) in GE stools.|From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
1260175|NCT00432380|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses|The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
1260176|NCT00432380|Secondary|Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea|Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 – less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature > 38.0 – ≤ 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.|During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses|The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
1260177|NCT00432380|Secondary|Serum IgA Antibody Concentrations Against Rotavirus|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.|||U/mL||95% Confidence Interval|Geometric Mean
1260178|NCT00432380|Secondary|Number of Seroconverted Subjects for Anti-RV IgA Antibody|Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.|||Subjects|||Number
1260179|NCT00432380|Primary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody|Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.|||Subjects|||Number
1260180|NCT00432341|Secondary|Patient Assessment of Need for Retreatment at Week 4|"Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?. The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection', and 'does not require injection'."|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at the time points are included.|||Number of Responses|||Number
1260181|NCT00432341|Secondary|Patient Visual Analog Assessment of Pain at Week 4|Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.|||Units on a Scale||Full Range|Median
1260182|NCT00432341|Secondary|Patient Comparison of Benefit to Previous Injections at Week 20|"Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 20|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.|||Number of Responses|||Number
1260183|NCT00432341|Secondary|Physician Comparison of Benefit to Previous Injections at Week 20|"Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 20|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.|||Number of Responses|||Number
1260184|NCT00432341|Secondary|Physician Assessment of Cervical Dystonia Severity at Week 4|Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever'|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.|||Units on a Scale||Full Range|Median
1260185|NCT00432341|Secondary|Global Assessment of Benefit by Physician at Week 4|Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Units on a Scale||Full Range|Median
1260186|NCT00432341|Secondary|Global Assessment of Benefit by Patient at Week 4|Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Units on a Scale||Full Range|Median
1260531|NCT00429364|Secondary|Annual Rate of Change in Body Mass Index||Up to 3 years following randomization.|All randomized participants whose body mass indexes were measured at baseline and at any of the follow-up visits.|||kg/m^2 per year||Standard Error|Least Squares Mean
1260187|NCT00432341|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4|The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Scores on a Scale||Full Range|Median
1260188|NCT00432341|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4|The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms). The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Scores on a Scale||Full Range|Median
1260189|NCT00432341|Primary|Duration of Treatment Benefit|Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].|20 Weeks|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Days||95% Confidence Interval|Median
1260190|NCT00432276|Secondary|Change From Baseline in Mean HDL Particle Size|Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
1260191|NCT00432276|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles|The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μmol/L||Standard Error|Least Squares Mean
1260192|NCT00432276|Secondary|Change From Baseline in Mean LDL Particle Size|Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
1260193|NCT00432276|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles|The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1260194|NCT00432276|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles|The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline IDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1260195|NCT00432276|Secondary|Change From Baseline in Mean VLDL Particle Size|Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
1260196|NCT00432276|Secondary|Change From Baseline in VLDL Particles|The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1260197|NCT00432276|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.~Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron triglycerides as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260236|NCT00432237|Primary|Number of Patients Reporting Pain Relief at 2 Hours Post Dose|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose.~Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain."|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
1260198|NCT00432276|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.~Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron particles as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1260199|NCT00432276|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides|Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline NMR triglycerides as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260200|NCT00432276|Secondary|Change From Baseline in Adiponectin|Change from Baseline in adiponectin was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
1260201|NCT00432276|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein|Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
1260202|NCT00432276|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1|Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ng/ml||Standard Error|Least Squares Mean
1260203|NCT00432276|Secondary|Change From Baseline in Apolipoprotein C-III|Change from Baseline in Apolipoprotein C-III was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.|Baseline and Weeks 12, 26, 42 and 52.|Full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260204|NCT00432276|Secondary|Change From Baseline in Apolipoprotein B|Change from Baseline in Apolipoprotein B was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.|Baseline and Weeks 12, 26, 42 and 52.|Full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260205|NCT00432276|Secondary|Change From Baseline in Apolipoprotein A2|Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260206|NCT00432276|Secondary|Change From Baseline in Apolipoprotein A1|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260207|NCT00432276|Secondary|Change From Baseline in Free Fatty Acids|Change from Baseline in free fatty acids was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acids as covariates.|Baseline and Weeks 12, 26, 42, and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
1260208|NCT00432276|Secondary|Change From Baseline in Triglycerides|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260209|NCT00432276|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1286678|NCT00168831|Secondary|Change From Baseline in Calcium|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||millimoles per litre (mmol/L)||Standard Deviation|Mean
1260210|NCT00432276|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260211|NCT00432276|Secondary|Change From Baseline in Total Cholesterol|Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260212|NCT00432276|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was assessed at Weeks 4, 8, 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.|Baseline and Weeks 4, 8, 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||kg||Standard Error|Least Squares Mean
1260213|NCT00432276|Secondary|Change From Baseline in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5~The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
1260214|NCT00432276|Secondary|Change From Baseline in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5~A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
1260215|NCT00432276|Secondary|Change From Baseline in C-peptide|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1260216|NCT00432276|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin/insulin ratio as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1260217|NCT00432276|Secondary|Change From Baseline in Fasting Insulin|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting insulin as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μIU/mL||Standard Error|Least Squares Mean
1260218|NCT00432276|Secondary|Change From Baseline in Fasting Proinsulin|Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1260219|NCT00432276|Secondary|Percentage of Participants Meeting Hyperglycemic Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 7 days after the first sample and analyzed by the central laboratory:~After more than 2 weeks of treatment but prior to the Week 4 Visit: A single fasting plasma glucose (FPG) ≥275 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: A single FPG ≥250 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: A single FPG ≥225 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% AND ≤0.5% reduction in HbA1c as compared with the baseline HbA1c."|Baseline to Week 52|Full Analysis Set including patients with a postbaseline visit.|||percentage of participants|||Number
1260220|NCT00432276|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).|Baseline to Week 52|Full Analysis Set including patients with at least one non-missing fasting plasma glucose result in each treatment group.|||percentage of participants|||Number
1260221|NCT00432276|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline FPG as covariates.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug and where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1260222|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1260223|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1260224|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1260225|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1260226|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1260227|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1260228|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1260229|NCT00432276|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 34 and 42.|Per-protocol set. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1260230|NCT00432276|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change from Baseline to Week 26 and Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Weeks 26 and 52.|Per-protocol set included all randomized patients who received at least 1 dose of double-blind study medication and who had no major protocol violations. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1260231|NCT00432237|Secondary|Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose|Pain Freedom and no migraine-associated symptoms at 2 hours postdose.|2 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
1260232|NCT00432237|Secondary|Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose|Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.|2 to 24 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)|||Participants|||Number
1260233|NCT00432237|Primary|Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
1260234|NCT00432237|Primary|Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
1260235|NCT00432237|Primary|Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
1260237|NCT00432237|Secondary|Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose|Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.|2 to 24 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)|||Participants|||Number
1260238|NCT00432237|Primary|Number of Patients Reporting Pain Freedom at 2 Hours Postdose|"Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose.~Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain."|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
1260239|NCT00432159|Secondary|Average Radiographic Disc Height (mm) - Change From Post-op||24 months|As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||mm||Standard Deviation|Mean
1260240|NCT00432159|Secondary|Global Cervical Range of Motion - Change From Baseline||24 months|As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||degrees||Standard Deviation|Mean
1260241|NCT00432159|Secondary|Subject Satisfaction|Subject Satisfaction (Would you have this procedure again?)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants|||Number
1260242|NCT00432159|Secondary|Activity|Clinical Assessment of Activity|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants|||Number
1260243|NCT00432159|Secondary|Return to Work|Estimated Proportion of Subjects Returning to Work|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||% of subjects who returned to work|||Number
1260244|NCT00432159|Secondary|Work Status Assessment||24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants|||Number
1260245|NCT00432159|Secondary|SF-36 - Mental Composite Scores (MCS) - Change From Baseline|Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
1260246|NCT00432159|Secondary|SF-36 - Physical Composite Scores (PCS) - Change From Baseline|Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
1260247|NCT00432159|Secondary|Dysphagia Disability Index - Change From Baseline|Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as “always” 4, “sometimes” 2, or “never” 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
1260248|NCT00432159|Secondary|Average Shoulder Pain VAS - Change From Baseline|Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
1260272|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group)|||ng/mL||Standard Deviation|Mean
1260249|NCT00432159|Secondary|Maximum Shoulder Pain VAS - Change From Baseline|Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
1260250|NCT00432159|Secondary|Average Arm Pain VAS - Change From Baseline|Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
1260251|NCT00432159|Secondary|Maximum Arm Pain VAS - Change From Baseline|Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
1260252|NCT00432159|Secondary|Neck Pain VAS Scores - Change From Baseline|Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Error|Mean
1260253|NCT00432159|Secondary|NDI - Change From Baseline|Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||NDI Score||Standard Deviation|Mean
1260254|NCT00432159|Secondary|Device-Related SAE Component of Success|no device related serious adverse events|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants who are successes|||Number
1260255|NCT00432159|Secondary|Subsequent Secondary Surgery Component of Success|no subsequent secondary surgical intervention at the index level|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants who are successes|||Number
1260256|NCT00432159|Secondary|Neurological Component of Success|no new clinically significant permanent abnormalities in neurological function|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants who are successes|||Number
1260257|NCT00432159|Secondary|NDI Success|15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants who are successes|||Number
1260258|NCT00432159|Primary|Overall Success|Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.|24 months|The primary outcome was analyzed with an Intent to Treat (As Randomized) analysis. The difference between the number of treated patients and the number of participants analyzed for each group at the 24 month visit is due to: death of one randomized ACDF patient and patients with no data for NDI and Neurological function (missing data).|||participants who are successes|||Number
1260259|NCT00432042|Primary|Post-vaccination Geometric Mean Titres (GMT) to Pertussis|The GMT to pertussis were compared in Arm1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa. Anti-pertussis toxin (anti-PT), anti-filamentous hemagglutinin (anti-FHA), and anti-pertactin (anti-PRN) were determined using ELISA on solid phase based on sandwich principle.|Day 42|Participants in Arm 1 and Arm 3 who had post-vaccination serology results and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 2 was not planned it was not included.|||GMT (IU/mL)||95% Confidence Interval|Number
1260260|NCT00432042|Primary|Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B|The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: Hepatitis B antibody titre ≥10 IU/mL and Haemophilus Influenzae Type b antibody titre ≥1 ug/mL. Hepatitis B antibody levels were determined using anti-HBs ORTHO ECi Immunodiagnostic Assay. Haemophilus Influenzae Type b antibody (anti-polyribosylribitol phosphate [PRP]) levels were determined with radioimmunoassay (RIA) or with enzyme immunoassay (EIA).|Day 42|Participants in Arm 1 and Arm 3 who had post-vaccination serology results and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 2 was not planned it was not included.|||Percentage of participants||95% Confidence Interval|Number
1260261|NCT00432042|Primary|Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella|The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 2: ProQuad® was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA).|Day 42|Participants in Arm 1 and Arm 2 who were initially seronegative to measles, mumps, rubella, or varicella; had post-vaccination serology results; and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 3 was not planned it was not included.|||Percentage of Participants||95% Confidence Interval|Number
1260262|NCT00431964|Primary|Change in FEV1 From Baseline to End of Treatment at Day 168||change from baseline to day 168|Modified intent to treat (randomized and at least one dose of study drug).|||liters||Standard Deviation|Mean
1260263|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)|Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).|||mg||Standard Deviation|Mean
1260264|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)|Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects|||mg||Standard Deviation|Mean
1260265|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).|||ng*hr/mL||Standard Deviation|Mean
1260266|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)|||ng*hr/mL||Standard Deviation|Mean
1260267|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects|||ng*hr/mL||Standard Deviation|Mean
1260268|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½|t½: Observed terminal elimination half-life determined after the last dose on Day 21|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).|||hours||Standard Deviation|Mean
1260269|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group)|||hours||Standard Deviation|Mean
1260270|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)|||hours||Standard Deviation|Mean
1260271|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects|||hours||Standard Deviation|Mean
1260273|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)|||ng/mL||Standard Deviation|Mean
1260274|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects|||ng/mL||Standard Deviation|Mean
1260275|NCT00431951|Primary|Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table|"Evaluated safety parameters included:~physical examination/vital signs~electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)~laboratory safety tests (hematology, chemistry, urinalysis)~adverse events (AEs) For a)-c), statistical values (mean, standard deviation, median, minimum, maximum) and changes from baseline (Day 1 pre-dose) to each time-point, were compared to laboratory normal reference ranges. If values for a)-d) were a Grade 3 or higher (in DAIDS AE Table)and ST-246-related, they were considered severe and significant, respectively."|Days 1, 6, 14-16, 21-24, 28-31, and 51-53|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each, and one placebo group with 6 subjects. A total of 7 withdrawals during the entire study were due to inability to follow procedure (4), lost to follow-up (1), requested due to concomitant medication (1), and an adverse event (1)|||Participants|||Number
1260276|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
1260277|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
1260278|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the satisfaction with outcomes scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
1260279|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
1260280|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS):Life Control|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
1260281|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the health care satisfaction scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
1260282|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
1260283|NCT00431847|Primary|Post Traumatic Stress Disorder (PTSD) Total Severity|Post-Traumatic Stress Disorder Checklist (PCL): The PCL is a 17-item PTSD assessment instrument that asks respondents to rate the extent to which they have experienced each of the 17 diagnostic symptoms for PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). Scores are computed by adding the 17 items scored 1 to 5. Scores range from 17 to 85. Higher scores indicate higher severity of symptoms.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the PCL scale||Standard Error|Mean
1260284|NCT00431847|Primary|SF-36 Mental Component Summary|The Mental component score (MCS) is an aggregate of the eight subscale scores that account for measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the U.S. general population from an individual’s scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the MCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the MCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||t-score||Standard Error|Mean
1260285|NCT00431847|Primary|SF-36 Physical Component Summary|The Physical component score (PCS) is an aggregate of the eight subscale scores measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is calculated for each by subtracting the scale mean of a sample of the U.S. general population from an individual’s scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the PCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the PCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||t-score||Standard Error|Mean
1260286|NCT00431847|Primary|Brief Pain Inventory - Treatment Relief|The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess the severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures in the last 24 hours, how much relief pain treatments or medications provided on a scale of 0%, meaning no relief, to 100%, indicating complete relief.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||percentage of pain relief||Standard Error|Mean
1260287|NCT00431847|Primary|Brief Pain Inventory - Pain Interference|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is scored as the mean of the seven interference items, each ranging 0 to 10, where 0 is pain from combat limb injury does not interfere and 10 is pain from combat limb injury completely interferes with this aspect of daily life."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Brief Pain Inventory Scale||Standard Error|Mean
1260288|NCT00431847|Primary|Brief Pain Inventory - Average Pain|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Average Pain asks the respondent to rate combat limb injury pain on average (no time frame given) on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Brief Pain Inventory Scale||Standard Error|Mean
1260289|NCT00431847|Primary|Brief Pain Inventory - Worst Pain|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Worst Pain asks the respondent to rate worst pain in the past week from the combat limb injury on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Brief Pain Inventory Scale||Standard Error|Mean
1260290|NCT00431847|Primary|Neuropathic Pain Scale - Total Score|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. It has a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The NPS total score is an average of all ten items."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Neuropathic Pain Scale||Standard Error|Mean
1260291|NCT00431847|Primary|Neuropathic Pain Scale - Overall Pain Quality|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. The NPS Overall Pain Quality composite score is a measure of six distinct pain qualities of respondents' combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The six pain qualities included in the composite score is sharp, hot, dull, cold, itchy, and sensitive to touch."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Neuropathic Pain Scale||Standard Error|Mean
1260292|NCT00431847|Primary|Neuropathic Pain Scale - Pain Intensity|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. Item numbers ask respondents to describe the intensity of their combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense pain imaginable."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Neuropathic Pain Scale||Standard Error|Mean
1260293|NCT00431834|Primary|Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|30 days post procedure or hospital discharge|Entire study population.|||Percentage of subjects||95% Confidence Interval|Number
1260294|NCT00431834|Secondary|Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure|Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|6 months|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.|||percentage of subjects|||Number
1260295|NCT00431834|Secondary|Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months||6 months|75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.|||percentage of subjects|||Number
1260296|NCT00431834|Primary|Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively.|Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.|6 months|75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.|||percentage of participants||95% Confidence Interval|Number
1260297|NCT00431626|Primary|Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index|AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)|one year||||units on a scale||Standard Deviation|Mean
1260298|NCT00431496|Secondary|Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL|The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
1260299|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L|The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
1260300|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L|The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
1260301|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)|The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
1260302|NCT00431496|Secondary|Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL|Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
1260303|NCT00431496|Primary|Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2|The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
1260304|NCT00431444|Secondary|Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens|At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: “once a year i.v. infusion,” “once daily pill,” or “both are equal.”|At 6 month visit|Intention-to-treat (ITT) population.|||Participants|||Number
1260305|NCT00431444|Secondary|Overall Patient Satisfaction Assessed by Satisfaction Questionnaire|Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.|||Participants|||Number
1260306|NCT00431444|Secondary|Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire|The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient’s i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.|||Participants|||Number
1260917|NCT00426751|Secondary|Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI|The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.|until 6 Month (Day 180) after index-MI|Safety Population|||participants|||Number
1260307|NCT00431444|Secondary|Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire|The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient’s i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.|||Participants|||Number
1260308|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months||Baseline and 6 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||U/L||Standard Deviation|Mean
1260309|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months||Baseline and 4 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||U/L||Standard Deviation|Mean
1260310|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months||Baseline and 2 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||U/L||Standard Deviation|Mean
1260311|NCT00431444|Secondary|Change From Baseline in Urine NTx at 4 Months|The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 4 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||nM BCE/mM Cr||Standard Deviation|Mean
1260312|NCT00431444|Secondary|Change From Baseline in Urine NTx at 2 Months|The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 2 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||nM BCE/mM Cr||Standard Deviation|Mean
1260313|NCT00431444|Primary|Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)|The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 6 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||nM BCE/mM Cr||Standard Deviation|Mean
1260314|NCT00431184|Secondary|Young Mania Rating Scale (YMRS)|The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale.|at the time of administration of intervention and 5 hours following administration of intervention||||units on a scale||95% Confidence Interval|Mean
1260315|NCT00431184|Primary|Mania Acute Rating Scale (MACS)|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.|On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention||||units on a scale||95% Confidence Interval|Mean
1260316|NCT00431132|Secondary|Transvaginal Ultrasound: Endometrial Thickness|Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.|Week 0, week 52|Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.|||mm||Standard Deviation|Mean
1260317|NCT00431132|Primary|Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies|The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.|Week 52|Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.|||percentage of participants|||Number
1260318|NCT00431067|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|From first OR to time of progression or death|TS - patients with OR only.|||days||Standard Deviation|Mean
1260319|NCT00431067|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|From first dose of study medication to time when OR measurement was taken.|TS. There were only 4 patients who responded.|||days||95% Confidence Interval|Median
1260320|NCT00431067|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.|From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month|TS (14 patients died)|||days||95% Confidence Interval|Median
1260321|NCT00431067|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria.|From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month|TS|||days||95% Confidence Interval|Median
1260322|NCT00431067|Primary|Objective Response (OR)|Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .|From first dose of study medication to response measurement, up to 34 month|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
1260323|NCT00431041|Secondary|Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary|"Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline."|Baseline and 8 weeks|Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study|||urgency episodes per day||Standard Deviation|Mean
1260324|NCT00431041|Secondary|Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary|"Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline."|Baseline and 8 Weeks|Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study|||Micturitions per day||Standard Deviation|Mean
1260325|NCT00431041|Primary|The Severity of Dry Mouth Reported as an Adverse Event|"The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).~Dry mouth severity was categorized as mild (relieved with fluid/hard candy), moderate (dry mouth and throat with no difficulty swallowing solid food/water) & severe (very dry mouth & throat, difficulty swallowing solid food without water)"|8 weeks|Data represents ITT Population: all randomized subjects|||participants|||Number
1260326|NCT00431041|Primary|The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event|The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit|8 weeks|Data represents ITT Population: all randomized subjects|||participants|||Number
1260327|NCT00430950|Secondary|Number of Participants Achieving Blood Pressure Goal.||8 weeks||||participants|||Number
1260328|NCT00430950|Secondary|Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.|Change = Week 16 - Week 8 (baseline).|8 weeks|Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP.|||mm Hg||Standard Deviation|Mean
1260329|NCT00430950|Secondary|Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.|4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).|8 weeks||||mm Hg||Standard Deviation|Mean
1260330|NCT00430950|Secondary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12|Change = Week 12 - Week 8 (baseline).|4 weeks||||mm Hg||Standard Deviation|Mean
1260331|NCT00430950|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure|"Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.~Change = Week 16 - Week 8 (baseline)."|8 weeks|The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres.|||mm Hg||Standard Deviation|Mean
1260332|NCT00430937|Secondary|Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.|"Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation.~Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation."|Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks|Population analyzed consisted of patients from the clinically evaluable population who had microbiological assessments.|||Participants|||Number
1260333|NCT00430937|Primary|"Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population."|"Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement).~Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy."|Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks|The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for cSSTI as listed in the Protocol, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.|||Participants|||Number
1260334|NCT00430781|Primary|Progression-free Survival (PFS) in Final Analysis|PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population|||Weeks||90% Confidence Interval|Median
1260335|NCT00430781|Secondary|Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib|Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data.|From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks)|Safety Population: all participants who received at least one dose of study drug|||participants|||Number
1260336|NCT00430781|Secondary|Duration of Response|For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population. The median for lapatinib was not reached at the time of data cut-off. No formal analysis of this endpoint was conducted for this group due to a very small number of responding participants.|||weeks||90% Confidence Interval|Mean
1260337|NCT00430781|Secondary|Time to Response|For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population|||weeks||90% Confidence Interval|Mean
1260338|NCT00430781|Secondary|Response|Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population|||participants|||Number
1260339|NCT00430781|Secondary|Clinical Benefit Response|Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population|||participants|||Number
1260340|NCT00430781|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks)|ITT Population|||Weeks||90% Confidence Interval|Median
1260341|NCT00430781|Primary|Progression-free Survival (PFS) in Interim Analysis|PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis.|From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)|Intent to Treat (ITT) Population: all randomized participants|||Weeks||90% Confidence Interval|Median
1260342|NCT00430768|Secondary|hAAT Expression in Blood Measured Using M-specific Allele ELISA|4 subjects received prior AAT augmentation therapy; 2 subjects from Group 1 having only washed out for only 28 days complicated the measurement of M-specific levels 2 subjects from group 1 and the other subject did not have an appreciable change in M-specific AAT levels. Thus reporting only Cohorts 2 and 3. After day 90 patients were able to resume AAT protein therapy and thus levels were not collected following commencement of therapy on 201 and 303. 202, Day 365 blood hemolyzed; level not determinable.|Baseline, Days 14, 30, 45, 60, 90, (180, 270, and 365 if not on protein replacement therapy)|AAT Levels of each subject at various time points Baseline and Days following administration. 202 Day 365 blood hemolyzed; not determinable, 201 and 303 went back on AAT protein augmentation therapy after day 90, unable to collect M-specific levels on day 180, 270 and 303.|||nM|||Number
1260343|NCT00430768|Primary|Adverse Events Possibly, Probably or Definitely Related to Study Drug|"Adverse events considered possibly, probably or definitely related to study drug/study drug procedure Criteria to evaluate severity according to Attachment 2 of the Protocol~Mild toxicity, usually transient, requiring no special treatment and generally not interfering with usual daily activities~Moderate toxicity which may be ameliorated by simple therapeutic maneuvers, and impairs usual activities~Severe toxicity which requires therapeutic intervention and interrupts usual activities. Hospitalization may or may not be required~Life-threatening toxicity which requires hospitalization"|During 1 year after study agent administration|subjects in the group reporting the event|||participants|||Number
1260344|NCT00430755|Primary|Detection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History)|Data were extracted from hospital charts by to experienced physicians.; data from the computer histories were extracted by a senior physician, who tabulated comparisons between the 2 sets of records. We used the number of problems reported by Computer Assisted History that were not reported by Physician. Nurses at Robert Bosch Krankenhaus do not take medical histories in regard to allergies or adverse drug reactions. Pharmacists make no entries into charts and have no separate records of drug allergies or history of adverse drug reactions. Data on these issues either are obtained only by physician interview of the patient.|participants were followed for the duration of hospital stay, an average of 8 days|The rest did not end the history tool|||medical problems|||Number
1260400|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.||Baseline to 12 weeks|232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
1286679|NCT00168831|Secondary|Change From Baseline in Monocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1260345|NCT00430716|Secondary|Change From Baseline in BORG Dyspnoea Score at Week 12|BORG dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum).|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||Units on a scale||95% Confidence Interval|Mean
1260346|NCT00430716|Secondary|Change From Baseline in TAPSE Measurement at Week 12|TAPSE was measured as the total displacement of the tricuspid annulus in cm from end diastole to end systole.TAPSE is an indicator of progression of PAH / RV dysfunction.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||cm||95% Confidence Interval|Mean
1260347|NCT00430716|Secondary|Change From Baseline in Pro-BNP at Week 12|Pro- BNP which is a precursor of BNP, is a non-invasive biomarker and an indicator of progression of PAH / RV dysfunction in participants with PAH.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||pg/mL||95% Confidence Interval|Mean
1260348|NCT00430716|Secondary|Change From Baseline in BNP at Week 12|BNP is a non-invasive biomarker and an indicator of progression of PAH/ RV dysfunction in participants with PAH.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||pg/mL||95% Confidence Interval|Mean
1260349|NCT00430716|Secondary|Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12|PAH Criteria for WHO Class: Class I (Participants without resulting limitation of physical activity);Class II (Participants with slight limitation of physical activity though comfortable at rest);Class III (Participants with marked limitation of physical activity,though comfortable at rest);Class IV(Participants with inability to carry out any physical activity without symptoms,manifest signs of right heart failure; dyspnoea and/or fatigue may even be present at rest; and discomfort is increased by any physical activity).|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1260350|NCT00430716|Secondary|Time to Clinical Worsening|Clinical worsening was defined as death; or lung transplantation; or hospitalization due to pulmonary hypertension; or initiation of prostacyclin therapy; or initiation of endothelin receptor antagonist therapy.|Baseline through Week 12|Due to very low number of events of clinical worsening reported, the statistical analysis was not conducted and hence data not reported.|||Days||Standard Error|Mean
1260351|NCT00430716|Secondary|Change From Baseline in mPAP at Week 12|mPAP was measured using a pressure transducer positioned at the mid-axillary line.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||mmHg||95% Confidence Interval|Mean
1260352|NCT00430716|Primary|Change From Baseline in the Total Distance Walked During 6MWT at Week 12|6 MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.|Baseline and Week 12|Intention to Treat (ITT population) included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.|||Meters||95% Confidence Interval|Mean
1260353|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)|preRX=pretreatment. Protein, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 OR 3 then use >=4. Glucose, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Blood, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Leukocyte esterase, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4.|From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
1260354|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN if preRX>ULN, use >1.05*preRX or <LLN. Potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN. Chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRX<LLN, use <0.75*preRX or >ULN if preRX>ULN, use >1.25*preRX or <LLN. Glucose, serum (mg/dL): <65 mg/dL, or >220 mg/dL. Glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRX <LLN, use <0.8*preRX or >ULN if preRX>ULN, use >2.0*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX <LLN, use <0.75*preRX. Cholesterol, total (mg/dL): >2*preRX. Triglycerides (mg/dL): >=2.5*ULN, or if preRX>ULN, use >=2.5*preRX. Triglycerides, fasting (mg/dL): >=2*ULN, or if preRX>ULN, use >2.0*preRX.|From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
1260401|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.|The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.|Baseline to week 12|145 female participants from both the olmesartan and placebo groups were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
1260355|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Hemoglobin (g/dL): >3g/dL decrease from preRX value. Hematocrit(%): <0.75*preRX. Erythrocytes (*10^6 c/uL): <0.75*preRX. Platelet count (*10^9 c/L): <0.67*LLN, or >1.5*ULN, or if preRX <LLN, use <0.5*preRX and <100,000/mm^3. Leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8* preRX or >ULN; if preRX>ULN, use >1.2*preRX or <LLN. Neutrophils + Bands (absolute) (*10^3 c/uL): If value <1.0*10^3 or if value >7.50*10^3 c/uL. Monocytes (absolute) (*10^3 c/uL): If value >2000/mm^3. Basophils (absolute)(*10^3 c/uL): If value >.750*10^3 c/uL. Eosinophils (absolute) (*10^3 c/uL): If value >.750*10^3 c/uL. ALP (U/L): >2*ULN, or if preRX>ULN, use >3* preRX. AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. GGT (U/L):>2*ULN, or if preRX >ULN, use >3*preRX. Bilirubin, total (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX. BUN (mg/dL): >1.5*preRX.|From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
1260356|NCT00430677|Secondary|Number of Participants Achieving Renal Response|Renal response=serum creatinine level ≤25% above baseline value and greater than or equal to 50% improvement in the urine protein/creatinine ratio with 1 of the following: urine protein/creatinine ratio (UPCR) <113 mg/mmol, if the baseline ratio was <= 339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio >339 mg/mmol.|At Day 365 (end of short-term period) and Day 645|All randomized participants who received treatment.|||participants|||Number
1260357|NCT00430677|Secondary|Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period|Collected in at least 1 sample. Assessment includes immunogenicity (detection of serum antibodies which bind to CTLA4-Ig in the in vitro assays) and exposure to corticosteroids|Day 365 to end of long-term extension period|Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available.|||Participants|||Number
1260358|NCT00430677|Secondary|Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.|From start of study drug in long-term period (Day 365) to up to 56 days after the last dose of the long-term extension (LTE). Deaths in LTE reported to >56 days post last dose.|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
1260359|NCT00430677|Secondary|Mean Change From Baseline in SLICC/ACR Damage Index|SLICC=Systemic Lupus International Collaborating Clinics; ACR=American College of Rheumatology. The SLICC/ACR Damage Index measures organ damage (nonreversible change, unrelated to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months unless otherwise stated. The index assesses 47 items in 12 systems: Ocular, Neuropsychiatric, Renal, Pulmonary, Cardiovascular, Gastrointestinal, Peripheral Vascular, Musculoskeletal, Skin, Premature Gonadal Failure, Diabetes, Malignancy. Scores range from 0 to 2, and the same lesion cannot be scored twice. If damage is noted for a particular item, it is scored 1. No damage is scored 0. Some items may score 2 points if they occur more than once, so that the maximum possible score is 47. Scores can only increase with time, but scores rarely reach over 12. It is usually completed (or updated) yearly.|Day 365 to termination of the long-term extension phase|All randomized participants who received treatment. Treated participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e, Change from baseline greater than or equal to 0). 99, 99 and 100 participants were treated respectively. Refer to outcome measure 11 for baseline values|||Units on a scale||Standard Error|Mean
1260360|NCT00430677|Secondary|Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis|Patient response=complete, partial, or no response. Complete response=serum creatinine (SCr) normal, inactive urinary sediment, no cellular casts, urinary protein/creatinine (UPCR) ratio<56.5 mg/mmol. Partial response=SCr normal or ≤25% above baseline value, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the baseline ratio. No response=Not achieving complete or partial response criteria.|At Day 365 (end of Short-term Period) and Day 645|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
1260361|NCT00430677|Secondary|Number of Participants Achieving Complete Response by ACCESS Definition|The Abatacept and Cyclophosphamide Combination Efficacy and Safety Study (ACCESS) defines complete response as a response meeting all of the following criteria: serum creatinine ≤upper limit of normal as defined by the central laboratory or ≤125% of the higher value at either screening or baseline; urine protein/creatinine ratio <50 mg/mmoL; and prednisone or prednisone-equivalent dose tapered to 10 mg per day.|End of short-term period (Day 365) to termination of the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||participants|||Number
1260362|NCT00430677|Secondary|Change in Quantitative Immunoglobulin From Baseline During Short-term Period|"A quantitative immunoglobulin (Ig) test is used to detect abnormal levels of the 3 major classes of Ig (IgG, IgA, and IgM). Abnormal test results typically indicate that something is affecting the immune system and further testing is required.~Please refer to Outcome 31 for the respective baseline values"|Day 365|All randomized participants who received treatment. n=Participants with both postbaseline and baseline measurements|||mg/dL||Standard Deviation|Mean
1260363|NCT00430677|Secondary|Baseline Quantitative Immunoglobulins During the Short-term Period|A quantitative immunoglobulins (Igs) test is used to detect abnormal levels of the three major classes of Igs (IgG, IgA, and IgM). Abnormal test results typically indicate that there is something affecting the immune system which requires further testing.|Baseline (Day 1)||||mg/dL||Standard Error|Mean
1260364|NCT00430677|Secondary|Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period|A validated, sensitive electrochemiluminescence (ECL) immunoassay based on Meso-Scale Discovery instrumentation was used to evaluate immunogenicity. The ECL assay differentiated between two antibody specificities: (1) the ‘Ig and/or Junction (Jn) Region’ and (2) ‘CLTA4 and possibly Ig’. A sample was considered positive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept with or without CTLA4-T.|Day 169, Day 365|Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available. n= number of participants who are evaluated|||Participants|||Number
1260365|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Temperature||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.|||degree celcius||Standard Deviation|Mean
1260366|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Heart Rate||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.|||beats per minute||Standard Deviation|Mean
1260367|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.|||mm Hg||Standard Deviation|Mean
1260368|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.|||mmHg||Standard Deviation|Mean
1260369|NCT00430677|Secondary|Participants With Marked Abnormalities Urinalysis During the Short-term Period|PTV=pretreatment value. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase , if missing PTV then use >=2+ (or, if value >=4, or if PTV=0 or 0.5, >=2 or if PTV=1, >=3, or if PTV=2 or 3, >=4).|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements|||Participants|||Number
1260370|NCT00430677|Secondary|Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period|"ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age.~Alkaline Phosphatase:>2x ULN; ↑Aspartate Aminotransferase: >3x ULN; ↑Alanine Aminotransferase : >3x ULN; G-Glutamyl Transferase : >2x ULN; ↑Total Bilirubin : >2x ULN or if PTV > ULN then > 4x PTV; ↑Blood Urea Nitrogen >2x PTV; ↑Creatinine >1.5x PTV."|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements|||Participants|||Number
1260371|NCT00430677|Secondary|Participants With Marked Laboratory Abnormalities During the Short-term Period|LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. ↑Serum Sodium:>1.05x ULN;↓Serum Potassium:<0.9x LLN;↑Serum Potassium:>1.1x ULN;↓Total Calcium:<0.8X LLN;↑Total Calcium:>1.2x ULN; ↓Serum Glucose(SG):<65 mg/dL;↑SG:>220 mg/dL;↓Fasting SG:<0.8x LLN;↑Fasting SG:>1.5x ULN;↓Total Protein:<0.9x LLN;↓Albumin:<0.9x LLN;↑Total Cholesterol:>2x PTV;↑Triglycerides:>=2.5x ULN;↑Fasting Triglycerides:>=2x ULN|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements|||Participants|||Number
1260372|NCT00430677|Secondary|Participants With Marked Hematology Abnormalities During the Short-term Period|LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. Low(↓)Hemoglobin:>3g/dL decrease from PTV; ↓Hematocrit:<0.75xPTV;↓Erythrocyte count:<0.75xPTV; high(↑)Platelet count:>1.5xULN;↓Platelet count:<0.67xLLN;↓Leukocyte count:<0.75X LLN;↑Leukocyte count:>1.25xULN;↓Absolute(AB)Neutrophils+Bands:<1.00x10^3c/uL;↑AB Lymphocyte count:>7.50x10^3 c/uL; ↓AB lymphocyte count:<0.750x10^3 c/uL;↑AB monocyte count:>2000/mm^3;↑AB basophil count:>400/mm^3;↑AB eosinophil count:>0.750x10^3 c/uL.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements|||Participants|||Number
1260373|NCT00430677|Secondary|Participants With AEs of Special Interest During the Short-term Period|AEs of special interest were prospectively identified to be those that may be associated with the use of immunomodulatory agents. They are a subset of all AEs and may be either serious or non-serious.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population.|||Participants|||Number
1260374|NCT00430677|Secondary|Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population.|||Participants|||Number
1260375|NCT00430677|Secondary|Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period|The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population (all randomized and treated subjects). To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.|||Units on a scale||Standard Error|Least Squares Mean
1260376|NCT00430677|Secondary|Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period|The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1260377|NCT00430677|Secondary|Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period|"A visual analogue scale is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured.~The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue."|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.|||Units on a scale||Standard Error|Mean
1260378|NCT00430677|Secondary|Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period|A visual analogue scale (VAS) is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured. The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1260379|NCT00430677|Secondary|Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward (LOCF), participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.|||Units on a scale||Standard Error|Mean
1260380|NCT00430677|Secondary|Baseline Mental Component Summary of the Short SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1260381|NCT00430677|Secondary|Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.|||Units on a scale||Standard Error|Mean
1260402|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.|The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.|Baseline to week 12|131 male participants|||mm Hg||Standard Error|Least Squares Mean
1260382|NCT00430677|Secondary|Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1260383|NCT00430677|Secondary|Change in SLICC/ACR Damage Index From Baseline During Short-term Period|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. Change from baseline=Postbaseline - baseline value.|Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)|All randomized participants who received treatment and who had postbaseline and baseline measurements showing nonreversible changes (change from baseline >=0) in the SLICC-ACR Damage Index|||Units on a scale||Standard Error|Mean
1260384|NCT00430677|Secondary|Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period|RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) <113 mg/mmol,, if the baseline ratio was <=339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio > 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n>=5.|Month 12|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants||95% Confidence Interval|Number
1260385|NCT00430677|Other Pre-specified|Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period|"PR is either CRR, Partial Renal Response(PRR),or no Response(NR).~CRR= Serum creatinine(SC)is normal, Inactive urinary sediment, No cellular casts, Urinary protein/creatinine (UPCR) ratio <56.5 mg/mmoL; PRR= SC is normal OR SC not >25% above BL, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the BL ratio; NR= Not achieving either a CRR or a PRR. Participants achieved response if criteria at both months 11 and 12 (Days 337 and 365) were met. Participants who Early discontinuations were categorized as NR."|Month 12|All randomized participants who received treatment.|||Participants|||Number
1260386|NCT00430677|Secondary|Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.|Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)|n=Participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e., Change from Baseline greater than or equal to 0).|||Units on a scale||Standard Deviation|Mean
1260387|NCT00430677|Secondary|Change in Renal Function From Baseline Over Time During Short-term Period|Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value.|Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|ITT population (all randomized and treated subjects). n= Number of participants with both baseline and post-baseline measurements for that time point.|||milliliters per minute (mL/min)/1.73 m^2||Standard Error|Mean
1260388|NCT00430677|Secondary|Baseline Renal Function Over Time During Short-term Period|Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A negative value indicates worsening.|Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|n= Number of participants with measurements for that time point. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||milliliters per minute (mL/min)/1.73 m^2||Standard Deviation|Mean
1260389|NCT00430677|Secondary|Number of Months CRR Was Maintained During Short-term Period|Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR.|Day 1 (randomization) to 12 Months|All randomized participants who received participants.|||Months||Full Range|Median
1260418|NCT00430508|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.|Change = Week 12 - Week 8 (baseline).|4 weeks, change = week 12 - week 8|Full Analysis Set-Last Observation Carried Forward|||mm Hg||Standard Deviation|Mean
1260419|NCT00430508|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Last Observation Carried Forward.|||mm Hg||Standard Deviation|Mean
1260390|NCT00430677|Secondary|Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period|CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate [GFR] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|At Month 12 from Day 1|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants||95% Confidence Interval|Number
1260391|NCT00430677|Secondary|Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)|RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts.|Day 1 (randomization) to 12 months.|All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation|||Days||95% Confidence Interval|Median
1260392|NCT00430677|Secondary|Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|At Month 12 from Day 1|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants|||Number
1260393|NCT00430677|Secondary|Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|Day 1 to 12 months|All randomized participants who received treatment. Participants who discontinued early without meeting the confirmed CRR criteria were imputed as nonresponders.|||Participants|||Number
1260394|NCT00430677|Primary|Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|Day 1 (randomization) to 12 months.|All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation.|||days|||Number
1260395|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives||Baseline to 12 months|146 Stage 2 hypertensive participants from both the olmesartan and placebo groups|||mm Hg||Standard Deviation|Least Squares Mean
1260396|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives||Baseline to 12 weeks|130 Stage 1 hypertensive participants from both the olmesartan and placebo groups.|||mm Hg||Standard Deviation|Least Squares Mean
1260397|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.||Baseline to 12 weeks|221 non-Black participants from both the olmesartan and placebo groups were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
1260398|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.||Baseline to week 12|55 Black participants from both the olmesartan and placebo groups were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
1260399|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.||Baseline to 12 weeks|44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
1260420|NCT00430508|Secondary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.|Change = Week 12 - Week 8 (baseline).|4 weeks, change = week 12 - week 8|Full Analysis Set-Last Observation Carried Forward|||mm Hg||Standard Deviation|Mean
1260403|NCT00430638|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.|Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.|baseline to 12 weeks|The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group, but two were erroneously started with the 40mg dose. 139 is the correct number analyzed.|||mm Hg||Standard Error|Least Squares Mean
1260404|NCT00430638|Primary|Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.|The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.|baseline to 12 weeks|The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137.|||mm Hg||Standard Error|Least Squares Mean
1260405|NCT00430625|Secondary|Percent Change From Baseline to 12 Months in Chemokine (C-C Motif) Ligand 18 (CCL18)||Week 53|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed.|||Percent|||Number
1260406|NCT00430625|Secondary|Percent Change From Baseline to 12 Months in Plasma Chitotriosidase for Each Treatment Group|Percent Change from Baseline to Weeks 53 by Randomized velaglucerase alfa Treatment Group - Subset of intent to treat (ITT) Population who were wild type homozygous for chitotriosidase.|Week 53|2 patients in the 60 U/kg group and 7 patients in the 45 U/kg group who were wild type for the chitotriosidase mutation were analyzed; remaining patients were deficient in chitotriosidase activity.|||Percent|||Number
1260407|NCT00430625|Secondary|Change From Baseline to 12 Months in Normalized Spleen Volume (Percent Body Weight) for Each Treatment Group (Measured by Magnetic Resonance Imaging (MRI))|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population. Spleen Volume has been normalized for percent of body weight for each treatment arm. Spleen size relative to body weight = (Spleen volume [cc]/Body weight [kg])*100|Week 51|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||Percent body weight||95% Confidence Interval|Mean
1260408|NCT00430625|Secondary|Change From Baseline to 12 Months in Normalized Liver Volume (Percent Body Weight) for Each Treatment Group (Measured by Magnetic Resonance Imaging (MRI)|Liver Volume has been normalized for percentage of body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cc]/Body weight [kg])*100|Week 51|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||Percent body weight||95% Confidence Interval|Mean
1260409|NCT00430625|Secondary|Change From Baseline to 12 Months in Platelet Counts for Each Treatment Group.|intent to treat (ITT) Population|Week 53|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||x10^9/L||95% Confidence Interval|Mean
1260410|NCT00430625|Secondary|Change From Baseline to 12 Months in Hemoglobin Concentration in 45 U/kg Treatment Group||Week 53|13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||(g/dL)||95% Confidence Interval|Mean
1260411|NCT00430625|Primary|Change From Baseline to 12 Months in Hemoglobin Concentration for the 60 U/kg Treatment Group.|Efficacy endpoint|Week 53|12 patients in the 60 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||g/dL||95% Confidence Interval|Mean
1260412|NCT00430573|Secondary|Addiction Severity Index (ASI) Drug Use Composite Score|For the drug use composite scores, each of 13 questions about drug use is divided by its maximum answer value and by the total number of questions in the composite. These individual items are then summed, so that possible total scores range from 0 to 1, with higher scores reflecting greater drug use problem severity.|Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)|All randomized participants were asked to complete the ASI irrespective of taking study drug. At least one ASI was completed by 8 of the 10 randomized participants. At baseline 8 completed the ASI and the number of participants at each subsequent time point varied.|||units on a scale||Standard Deviation|Mean
1260413|NCT00430573|Primary|Percentage of Positive Toxicology Swabs for Illicit Substances|The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.|Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)|Toxicology swabs were obtained on all 10 randomized participants irrespective of taking study drug. At baseline all 10 had toxicology swabs, at treatment (week 12) 7 had toxicology swabs and at follow-up (week 18) 7 had toxicology swabs.|||percentage of positive toxicology swabs||Standard Deviation|Mean
1260414|NCT00430508|Secondary|Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases|||mm Hg||Standard Deviation|Mean
1260415|NCT00430508|Secondary|Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases|||mm Hg||Standard Deviation|Mean
1260416|NCT00430508|Secondary|Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases|||mm Hg||Standard Deviation|Mean
1260417|NCT00430508|Secondary|Number of Patients Achieving Target Blood Pressure at Week 16|Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics|8 weeks|Full Analysis Set-Last Observation Carried Forward|||participants|||Number
1260422|NCT00430495|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 38|Safety population included all randomized participants who received at least 1 treatment dose and had safety data following their first dose.|||participants|||Number
1260423|NCT00430495|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26|"The EULAR response criteria evaluate change in DAS28 scores represented as good response, moderate response, or no response considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have good or moderate EULAR response if at the time of assessment, their DAS28 score was <=5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2."|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
1260424|NCT00430495|Secondary|Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26|The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Percentage of participants achieving improvement in HAQ-DI of at least 0.3 from baseline at Week 26 was reported.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1260425|NCT00430495|Secondary|Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
1260426|NCT00430495|Secondary|Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100-millimeter (mm) visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
1260427|NCT00430495|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26|ACR70-CRP response is defined as >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
1260428|NCT00430495|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26|ACR50-CRP response is defined as >=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
1260429|NCT00430495|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26|ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
1260430|NCT00430352|Secondary|Percentage of Participants With PR Who Converted to CRu|Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population; only participants with PR to most recent treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1260532|NCT00429364|Secondary|Annual Rate of Change in Height-for-age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose heights were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
1260431|NCT00430352|Secondary|Percentage of Participants With Response by Best Response to Study Treatment|Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population; only participants who received any study treatment were included in the analysis.|||percentage of participants|||Number
1260432|NCT00430352|Secondary|Time to NLT - Time to Event|TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||months||95% Confidence Interval|Median
1260433|NCT00430352|Secondary|Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event|As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants|||Number
1260434|NCT00430352|Secondary|Overall Survival (OS) - Time to Event|OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants||95% Confidence Interval|Median
1260435|NCT00430352|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants|||Number
1260436|NCT00430352|Secondary|Event-Free Survival (EFS) - Time to Event|EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||months||95% Confidence Interval|Median
1260437|NCT00430352|Secondary|Event-Free Survival (EFS) - Percentage of Participants With an Event|The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants|||Number
1260438|NCT00430352|Secondary|Progression-Free Survival - Time to Event|PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||months||95% Confidence Interval|Median
1260439|NCT00430352|Secondary|Progression-Free Survival - Percentage of Participants With an Event|PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants|||Number
1260440|NCT00430352|Primary|Percentage of Participants With an Adverse Event (AE) - Overall Summary|Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.|24 months|Safety Population: any participant who received at least 1 dose of study treatment.|||percentage of participants|||Number
1260441|NCT00430300|Other Pre-specified|Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6|Data for this pre-specified endpoint was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
1260480|NCT00430248|Secondary|Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl|The percentage of subjects with mild-to-moderate renal impairment whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level.|||percentage of subjects|||Number
1260442|NCT00430300|Other Pre-specified|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||bpm||Standard Deviation|Mean
1260443|NCT00430300|Other Pre-specified|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8|Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia’s formula (QTcF=QT divided by cube root of RR Int) and Bazett’s formula (QTcB=QT divided by square root of RR Int).|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||milliseconds (msec)||Standard Deviation|Mean
1260444|NCT00430300|Other Pre-specified|Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1260445|NCT00430300|Other Pre-specified|Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6|Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||bpm||Standard Deviation|Mean
1260446|NCT00430300|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)|PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1260447|NCT00430300|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)|CGI-C: clinician’s global impression of a participant’s clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1260448|NCT00430300|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant’s daily values were averaged over each week.|Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter per minute||Standard Deviation|Mean
1260449|NCT00430300|Secondary|Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8|Participants were issued with rescue medication (Salbutamol MDI [100 mcg/actuation]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant’s daily use (puffs/day) was averaged over each week.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||puffs/day||Standard Deviation|Mean
1260450|NCT00430300|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8|COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant’s daily score for each symptom was averaged over each week.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1260528|NCT00429364|Secondary|Annual Rate of Change in Upper to Lower Segment Ratio||Up to 3 years following randomization.|All randomized participants whose upper to lower segment ratios were measured at baseline and at any of the follow-up visits.|||1/year||Standard Error|Least Squares Mean
1260451|NCT00430300|Secondary|Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6|BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.|Baseline, Week 2, 4, 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1260452|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator IC at Week 6|IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
1260453|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FVC at Week 6|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
1260454|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FEV6 at Week 6|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
1260455|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FEV1 at Week 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘N’(number of participants analyzed) signifies participants who were evaluable for this measure.|||liter||Standard Deviation|Mean
1260456|NCT00430300|Secondary|Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6|IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
1260457|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
1260458|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
1260459|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
1260460|NCT00430300|Secondary|Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8|IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
1260461|NCT00430300|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
1260462|NCT00430300|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
1260463|NCT00430300|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
1260464|NCT00430300|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 6|Full analysis set (FAS): all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Missing data were imputed using Last Observation Carried Forward (LOCF). Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
1260465|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.|The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Baseline and Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.|||percent change from baseline||Standard Deviation|Mean
1260466|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.|Baseline and Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.|||percent change from baseline||Standard Deviation|Mean
1260467|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit|Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.|Baseline and Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.|||percent change from baseline||Standard Deviation|Mean
1260468|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.|Baseline and Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.|||percent change from baseline||Standard Deviation|Mean
1260469|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit|The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.|||percentage of subjects|||Number
1260470|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.|||percentage of subjects|||Number
1260471|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.|||percentage of subjects|||Number
1260472|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.|||percentage of subjects|||Number
1260473|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.|The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.|||percentage of subjects|||Number
1260474|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.|||percentage of subjects|||Number
1260475|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.|||percentage of subjects|||Number
1260476|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit|||percentage of subjects|||Number
1260477|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.|||percentage of participants|||Number
1260478|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.|||percentage of subjects|||Number
1260479|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.|||percentage of subjects|||Number
1260481|NCT00430248|Primary|Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.|The percentage of subjects whose serum urate level was <6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained.|||percentage of subjects|||Number
1260482|NCT00430092|Primary|Anterior Chamber Cell Grade of “0” on Day 8 (Difluprednate QID vs Placebo).|Measured on a 0 to 4 scale: “0” is ≤ 1 cell; “1” is 2-10 cells; “2” is 11-20 cells; “3” is 21-50 cells; “4” is > 50 cells.|Day 8 (QID)|The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.|||participants|||Number
1260483|NCT00430027|Primary|Overall Toxicity|The primary objective of this pilot study was to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.|Up to 4 weeks|The study was terminated, study end points were not reached.||||||
1260484|NCT00429949|Secondary|Event-free Survival (EFS) for Participants With Relapsed Disease|EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.|Completion of treatment (median duration of therapy was 51 days)||||days||95% Confidence Interval|Median
1260485|NCT00429949|Secondary|Event-free Survival (EFS) for Participants With Plateau Phase Disease|EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.|Completion of treatment (median duration of therapy was 51 days)||||days||95% Confidence Interval|Median
1260486|NCT00429949|Secondary|Duration of Response|Duration of response is measured from the first date that criteria are met for complete response or partial response until the first date that criteria for relapse or progressive disease are met.|Completion of treatment (median duration of therapy was 51 days)|Only one patient achieved a partial response.|||cycles|||Number
1260487|NCT00429949|Secondary|Safety and Tolerability of Dasatinib (Grade III-IV Toxicities)|Toxicities were graded using the NCI Common Toxicity Criteria v3.0.|Up to 30 days following end of treatment (median duration of therapy was 51 days)||||participants|||Number
1260488|NCT00429949|Secondary|Time to Response|Time to response is measured from the start of treatment until the first date that criteria are met for complete response or partial response.|Completion of treatment (median duration of therapy was 51 days)|Only one patient achieved a partial response.|||cycles|||Number
1260489|NCT00429949|Primary|Response Rate [Complete Response (CR) and Partial Response (PR)]|"CR requires all of the following:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR.~< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow.~No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response).~Disappearance of soft tissue plasmacytoma~PR requires all of the following:~50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks.~-Reduction in 24 hr urinary light chain excretion by either > 90% or to < 200 mg, maintained for a minimum of 6 weeks.~50% reduction in the size of soft tissue plas"|Completion of treatment (median duration of therapy was 51 days)||||participants|||Number
1260490|NCT00429923|Primary|"Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo)."|Measured on a 0 to 4 scale: “0” is ≤ 1 cell; “1” is 2-10 cells; “2” is 11-20 cells; “3” is 21-50 cells; “4” is > 50 cells.|Day 8 (QID)|The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.|||participants|||Number
1260491|NCT00429793|Other Pre-specified|Patient Vital Status|Patients alive or dead after 24 months from time of study entry|Study entry up to 2 years||||participants|||Number
1260492|NCT00429793|Other Pre-specified|Reason Off Study Therapy||from study entry until end of study treatment||||participants|||Number
1260493|NCT00429793|Secondary|Duration of Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and evaluable patients.|||months||Inter-Quartile Range|Median
1260494|NCT00429793|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months up to 5 years|Eligible and evaluable patients|||months||Inter-Quartile Range|Median
1260495|NCT00429793|Primary|Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)||Up to 5 years|Eligible and evaluable patients.|||Participants|||Count of Participants
1260496|NCT00429793|Primary|Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.|Up to 5 years||||participants|||Number
1260497|NCT00429793|Primary|6 Month Progression-free Survival (PFS)|Number of participants who survived progression-free for more than 6 months.|6 months||||participants|||Number
1260498|NCT00429702|Secondary|Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy|CINV will be determined based on the number of rescue medications used during the 3 days following completion of chemotherapy cycle. Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy – it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient’s symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.|3 days of following completion of first chemotherapy cycle||||participants|||Number
1260499|NCT00429702|Primary|Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy|Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy – it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient’s symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.|during in-patient cycle of chemotherapy, up to 4 days||||participants|||Number
1260500|NCT00429663|Secondary|Valgus of Over 5 Degrees|Valgus is a deformity involving oblique displacement of part of a limb away from the midline.|12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.|||participants|||Number
1260501|NCT00429663|Primary|SMFA - Bother Index|The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.|||units on a scale||Standard Deviation|Mean
1260502|NCT00429663|Primary|EQ Index|EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.|||units on a scale||Standard Deviation|Mean
1260503|NCT00429663|Primary|Short Musculoskeletal Functional Assessment (SMFA) Score|The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered were followed.|||units on a scale||Standard Deviation|Mean
1260504|NCT00429663|Primary|EQ-5D|EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.|||units on a scale||Standard Deviation|Mean
1260505|NCT00429572|Primary|Number of Participants With Acute or Chronic GVHD And Response to Therapy|"Participants diagnosed with Graft versus Host Disease (GVHD) post transplant were divided into either acute (aGVHD), normally observed within the first 100 days post-transplant; and chronic GVHD (cGVHD) cases, normally occur after 100 days, then evaluated and scored according to standard criteria from Consensus conference on acute GVHD grading, Bone Marrow Transplant 1995; 15: 825-828, noted is type of case and whether responds to therapy."|Transplant to 1 year post transplant|As treated: Eighteen received the allogeneic transplantation.|||participants|||Number
1260506|NCT00429572|Primary|Grade II-IV Toxicity|Non-hematopoietic toxicity within the first year of transplantation, acute Graft versus Host Disease (GVHD) above National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade I and chronic above Grade I are reported by participant incidence. Broad classification of adverse events (AE) categories based on anatomy and/or pathophysiology; within each category, AEs are listed accompanied by their descriptions of severity (Grade, Grade 1 least severe).|Up to one year.|As treated: Eighteen received the allogeneic transplantation.|||Participants|||Number
1260507|NCT00429572|Primary|Time to Progressive Disease|Progression-free was measured, by days, at time from transplantation to development to disease or death from any cause, which ever occurred first.|Transplant to Progression.||||Days||Full Range|Median
1260508|NCT00429572|Primary|Overall Survival|Survival duration was calculated from time of transplantation by number of days.|Transplant until death.|As treated: Eighteen received the allogeneic transplantation.|||Days||Full Range|Median
1260529|NCT00429364|Secondary|Annual Rate of Change in Arm Span to Height Ratio||Up to 3 years following randomization.|All randomized participants whose arm span to height ratios were measured at baseline and at any of the follow-up visits.|||1/year||Standard Error|Least Squares Mean
1260509|NCT00429572|Primary|Number of Participants With Tumor Response|Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.|Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.|As treated: Eighteen received the allogeneic transplantation.|||participants|||Number
1260510|NCT00429507|Primary|Time to Progression|Time to progression is measured as the time from study entry to the development of disease progression.|7.5 Years, Study period was March 2007 to November 2014.||||Days||Full Range|Median
1260511|NCT00429494|Primary|Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide|Hormonal profile blood tests including follicle-stimulating hormone (FSH) test, luteinizing hormone (LH) and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by participants in a monitoring checklist sheet given to them.|6 months|Of the 59 patients who underwent HSCT, nine patients refused the second dose of leuprolide and were subsequently taken off study. Six patients died of either disease progression or transplantation-related complications before their ovarian function status was evaluated.|||participants|||Number
1260512|NCT00429416|Secondary|Number of Patients Who Achieve a CD4 Count > 200/Micro-liters|Determine the number of patients who achieve a CD4 count > 200/micro-liters by 60 days after transplant.|Through 60 Days Post Transplant||||participants|||Number
1260513|NCT00429416|Secondary|Rate of Serious Infectious Complications|"Determine the rate of serious infectious complications. A serious infection will be defined as any requiring hospitalization or parenteral therapy.~CD4 counts will be measured monthly for the first 3 months after transplant."|Through 3 months post-transplant||||participants|||Number
1260514|NCT00429416|Secondary|Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD)|Determine the incidence of grade II-IV acute GVHD after administration of grafts when combined with Cyclosporine/Mycophenolate Mofetil for GVHD prophylaxis. GVHD assessments occur daily as an in patient and at each out patient visit.|Through 24 months post-treatment||||participants|||Number
1260515|NCT00429416|Secondary|Rate of Engraftment of Non-Myeloablative Transplants|Determine the engraftment rate of non-myeloablative transplants using CD34+ stem cells and LLME treated CD34- products.|Through 30 days post-transplant||||participants|||Number
1260516|NCT00429416|Primary|Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality|"Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events.~This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included."|Through 100 days post-transplant or death||||participants|||Number
1260517|NCT00429403|Primary|Number of Patients With Response (FSH Level + Vaginal Bleeding)|Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, “response” defined as a composite event: both [FSH < 15] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.|Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year|Analysis was per protocol. Limited analysis due to low recruitment and early termination.|||participants|||Number
1260518|NCT00429364|Secondary|Adverse Drug Reactions Reported During Routine Follow-up Surveillance||From 6 months to 3 years following randomization.|All subjects who had any of the follow-up visits after 6 months post-randomization.|||participants|||Number
1260519|NCT00429364|Secondary|Adverse Drug Reactions Reported at the Baseline Visit||At baseline|All randomized participants.|||participants|||Number
1260520|NCT00429364|Secondary|Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.|Percentage of participants who had aortic dissection, aortic-root surgery or death over a 3-year period following randomization|Up to 3 years following randomization.|All randomized participants who received the treatment|||Percentage of participants||95% Confidence Interval|Number
1260521|NCT00429364|Secondary|Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.||Up to 3 years following randomization.|All randomized participants who received the treatment|||participants|||Number
1260522|NCT00429364|Secondary|Event Rate of Death|Percentage of participants who died over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment|||Percentage of participants||95% Confidence Interval|Number
1260523|NCT00429364|Secondary|Number of Death.||Up to 3 years following randomization.|All randomized participants who received the treatment|||participants|||Number
1260524|NCT00429364|Secondary|Event Rate of Aortic-Root Surgery|Percentage of participants who had aortic-root surgery over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment|||Percentage of participants||95% Confidence Interval|Number
1260525|NCT00429364|Secondary|Number of Participants With Aortic-root Surgery.||Up to 3 years following randomization.|All randomized participants who received the treatment|||participants|||Number
1260526|NCT00429364|Secondary|Event Rate of Aortic Dissection.|Percentage of participants who had aortic dissection over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment|||Percentage of participants||95% Confidence Interval|Number
1260527|NCT00429364|Secondary|Number of Participants With Aortic Dissection.||Up to 3 years following randomization.|All randomized participants who received the treatment|||participants|||Number
1260533|NCT00429364|Secondary|Annual Rate of Change in Height||Up to 3 years following randomization.|All randomized participants whose heights were measured at baseline and at any of the follow-up visits.|||cm/year||Standard Error|Least Squares Mean
1260534|NCT00429364|Secondary|Annual Rate of Change in Weight-for-height Z-score||Up to 3 years following randomization.|All randomized participants who were <120 cm in heights and whose weight-for-height z-scores were measured at baseline or at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
1260535|NCT00429364|Secondary|Annual Rate of Change in Weight-for-age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose weight-for-age z-scores were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
1260536|NCT00429364|Secondary|Annual Rate of Change in Weight||Up to 3 years following randomization.||||kg/year||Standard Error|Least Squares Mean
1260537|NCT00429364|Secondary|Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area||Up to 3 years following randomization.|All randomized participants whose total aortic proximal regurgitant jet area indexes were measured at baseline or at any of the follow-up visits.|||(mm^2/m^2)/year||Standard Error|Least Squares Mean
1260538|NCT00429364|Secondary|Annual Rate of Change in the Absolute Diameter of the Aortic Annulus||Up to 3 years following randomization.|All randomized participants whose absolute dimensions of the aortic annulus were measured at baseline and at any of the follow-up visits.|||cm/year||Standard Error|Least Squares Mean
1260539|NCT00429364|Secondary|Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area||Up to 3 years following randomization.|All randomized participants whose aortic-annulus-diameter z scores were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
1260540|NCT00429364|Secondary|Annual Rate of Change in the Absolute Diameter of the Ascending Aorta||Up to 3 years following randomization.|All randomized participants whose absolute dimensions of the ascending aorta were measured at baseline and at any of the follow-up visits.|||cm/year||Standard Error|Least Squares Mean
1260541|NCT00429364|Secondary|Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.||Up to 3 years following randomization.|All randomized participants whose ascending-aorta-diameter z scores were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
1260542|NCT00429364|Secondary|Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension|The rate of change in the absolute dimension of the aortic root over a 3-year period following randomization|Up to 3 years following randomization.||||cm/year||Standard Error|Least Squares Mean
1260543|NCT00429364|Primary|Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score|The rate of aortic root enlargement, expressed as the annual change in the maximum aortic-root-diameter z score indexed to body-surface area over a 3-year period following randomization|Up to 3 years following randomization.||||z-score/year||Standard Error|Least Squares Mean
1260544|NCT00429299|Secondary|Number of Variations/Somatic Mutation in PI3KCA at Baseline|Analysis of mutations in the PI3KCA gene was performed from RNA extracted from frozen tumor tissue samples (sections). A gene is either a wild-type (no mutation) or mutated (presence of a mutation). Exons 9 and 20 of the PI3KCA gene were accessed (high frequency mutation at these two spots).|Baseline|ITT Population. Only those participants for which high-quality tumor tissue samples were available were analyzed.|||Variations/Somatic mutations|||Number
1260545|NCT00429299|Secondary|Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment had been exercised in deciding whether reporting was appropriate in other situations.|From the first dose of randomized therapy to 30 days after the last dose of randomized therapy (assessed up to Study Week 29)|Safety Population: all randomized participants|||Participants|||Number
1260546|NCT00429299|Secondary|Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment|The percentage of inhibition of intermediate (EGFR, HER2, pMAPK, pAKT, PTEN, and PI3KCA) and final (TUNEL and Ki67) biomarkers of the proliferation and apoptosis pathways was calculated as the difference between the staining scores before (Baseline [biopsy]) and after treatment (withdrawal).|At Baseline and Withdrawal (assessed up to Study Week 29)|ITT Population. Only those participants contributing data to the indicated time points were analyzed.|||Percentage of inhibition||Full Range|Median
1260547|NCT00429299|Secondary|Number of Participants With Treatment Failure|Treatment failure is defined as the occurrence of local tumor progression (including ipsilateral and controlateral breast), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional arm), or death due to any cause.|From randomization up to 29 weeks|ITT Population|||Participants|||Number
1260548|NCT00429299|Secondary|Time to Treatment Failure From the Start of Primary Therapy|Time to treatment failure (TTF) is defined as the interval of time between the date of randomization and the earliest date of disease progression, premature treatment discontinuation and death due to any cause. The overall disease progression date is the earlier of the two disease progression dates from ultrasonography and mammography assessments. For ultrasonography, disease progression is defined as at least 20% increase in the longest diameter of the primary lesion at pre-surgery comparing to Baseline. For mammography, disease progression is defined as at least 20% increase in the larger nodule dimension at pre-surgery comparing to Baseline. For participants who has neither progressed, pre-maturely withdrawn or died, time to treatment failure will be censored at the latest date of ultrasonography and mammography tumor assessments.|From randomization up to Study Week 307|ITT Population: all participants who were randomized|||Months||95% Confidence Interval|Median
1260558|NCT00429169|Primary|Go-No go Test|Change in neuropsychological measure of impulsivity. Computer-based task involving induction of a dominant response tendency and testing of the subject's ability to withhold responding to less frequent non-target stimuli.|Measured at Baseline and Week 8|These were the number with analyzable data|||Commission errors||Standard Deviation|Mean
1260703|NCT00427973|Secondary|Overall Survival|Overall survival will be calculated using the Kaplan-Meier method, and confidence limits for survival estimates will be calculated using the Greenwood formula.|The time from study entry until death from any cause, assessed up to 1 year||||months||95% Confidence Interval|Median
1260549|NCT00429299|Secondary|Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS|The percentage of participants who had BCS and mastectomy and who were initiallycandidates for mastectomy and who actually had BCS was measured. At Baseline, the surgeon stated, within 4 weeks before starting the primary treatment, which type of surgical treatment he would perform in the absence of primary therapy and in the case of primary therapy (if the tumor size was reduced by the primary treatment to less than 3 centimeters), and the reasons for these choices. The rules for choosing the type of surgical treatment are reported in the Consensus Conference on Primary Treatment of Early Breast Cancer. The surgeon was to have re-evaluated the participant after primary treatment. In cases in which the type of surgical procedure was different from that originally programmed, the reason for this chance was to have been reported.|At Baseline and at surgery (up to Study Week 29)|Efficacy Analysis Population|||Percentage of participants|||Number
1260550|NCT00429299|Secondary|Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography|The clinical response was evaluated by comparing the tumor size (largest tumor diameter) before (at Baseline [biopsy]) and after treatment (before surgery), as assessed by ultrasonography examination. The clinical response was scored by Response Evaluation Criteria in Solid Tumors (RECIST) as follows: complete clinical response: the nodule is not detectable and all the ultrasound abnormality detected at diagnosis disappeared (margins circumscribed, round oval shape, parallel orientation, isoechoic echo pattern, no posterior acoustic features, echogenic lesion boundary, and tumor vascularity not present); partial clinical response: the longest diameter of the tumor has been reduced by >50%, and the ultrasound characteristics of the tumor persist; no response (stable disease): the longest diameter of the tumor has been reduced by <50% or has increased by no more than 20% from the starting value; progressive disease: tumor longest diameter has increased >20% from the starting value.|At Baseline and after primary treatment (within 2 weeks before surgery; up to Study Week 27)|Efficacy Analysis Population|||Percentage of participants|||Number
1260551|NCT00429299|Primary|Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes|Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery.|At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29)|Efficacy Analysis Population: all participants in the Intent-to-Treat Population (all participants who were randomized), except for the 2 participants who were excluded because of withdraw of consent and major protocol deviation|||Percentage of participants|||Number
1260552|NCT00429273|Primary|ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)|"The primary clinical efficacy variable for treatment was the ADHD-RS-IV Total Score and two sub-scales (Inattentive and Hyperactive-Impulsive ).~The rating scale has 18 questions with answer options: None (0), Mild (1), Moderate (2) and Severe (3).~Scores are obtained by summing each item; The higher the score, the worse the outcome.~Total score range: 0-54 Total Inattentive score range: 0-27 Total Hyperactive/Impulsive score range: 0-27"|Measured at baseline Week 4 and Week 8|Every contrast includes estimates of maturation/time trend and the within subject covariance structure based on all participants using full information maximum likelihood estimation.|||units on a scale||Standard Error|Least Squares Mean
1260553|NCT00429182|Secondary|Median Progression Free Survival (PFS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.|Overall study (baseline to disease progression)|Six participants were not evaluable for outcome assessment.|||months||Full Range|Median
1260554|NCT00429182|Primary|Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products|Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.|Baseline to 1 month post AHST|Twenty-one participants provided blood samples for the enumeration of CTCs, before apheresis (baseline) and at one month after AHST.|||participants|||Number
1260555|NCT00429169|Primary|Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.|"Comparison of fMRI results at baseline and after 8 weeks of antidepressant pharmacotherapy with paroxetine vs. bupropion.~Percent change in contrast of parameter estimates (COPE). COPE is measured during Monetary Incentive Delay Task.~Task conditions are:~Reward=BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment=BOLD signal when subject loses 5 cents vs. loses 0 cents"|Baseline and Week 8.|Major depressive disorder with suicidal thoughts or past suicide attempt.|||percentage of change in COPE||Full Range|Mean
1260556|NCT00429169|Primary|Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment|Suicide attempts, other suicidal behavior, or increase in suicidal thoughts that required a change in clinical treatment.|Measured at Month 6|These were the number of subjects with analyzable data.|||Events|||Number
1260557|NCT00429169|Primary|Scale for Suicidal Ideation|The clinician-rated Beck Scale for Suicidal Ideation (SSI) (Beck et al 1979)was used weekly for 8 weeks. It has 19 items scaled 0 (least severe) to 2 (most severe) and total score is the sum, ranging 0 to 38 (Beck et al 1979). Items measure frequency, intensity, and attitudes toward suicidal thoughts, feelings of control over them, and suicide plans. Mean score in 90 inpatients hospitalized for suicidal ideation was 9.4±8.4, versus 4.4±5.8 in outpatients as cited in the study by Beck et al, 1979.|Baseline and Week 8|The study was powered for N=50 subjects per group based on naturalistic pilot data from our clinic. An interim data analysis showed an interaction of treatment with baseline suicidal ideation severity on follow-up ideation. After consulting with clinical colleagues, statisticians and the IRB, a decision was made to stop enrollment.|||Points on Scale for Suicidal Ideation||Standard Deviation|Mean
1260559|NCT00429143|Secondary|Incidence of Grades III-IV GVHD|"To determine the incidence and severity of GVHD in these patients using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.'~Severity was graded using CTCAE 3.0 (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death)"|6 months|Two patients died prior to expected engraftment. Two patients who rejected were retransplanted and were evaluable for GVHD.|||participants|||Number
1260560|NCT00429143|Secondary|Lymphoid Recovery|To assess the pace of lymphoid recovery in this patient population.|6 months|Two patients did not engraft, two patients died prior to expected day of engraftment|||participants|||Number
1260561|NCT00429143|Secondary|Engraftment Rates|To assess hematopoietic engraftment rates.|6 months|Two patients died prior to expected engraftment day|||participants|||Number
1260562|NCT00429143|Primary|Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD|"To determine the optimal dose of CD3+ donor lymphocytes required for consistent engraftment without the development of grade III/IV GVHD.~Measured as CD3+ donor lymphocytes given as n x 10^8/kg.~n was found to be 2 and was found to be the optimal dose and was the only dose given."|6 months|Two patients died prior to expected day of engraftment|||lymphocytes x 10^8/kg|||Number
1260563|NCT00429143|Primary|Overall Survival of Participants|To determine overall survival at 6 months post-transplant.|6 months|27 Patients undergoing haploidentical transplant at Thomas Jefferson University|||participants|||Number
1260564|NCT00429104|Secondary|Duration of Stable Disease|Stable disease is measured from the start of the treatment until the RECIST criteria for disease progression is met.|6 Years|Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.|||weeks||Full Range|Median
1260565|NCT00429104|Primary|Number of Participants With Tumor Response (Stable Disease)|Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.|2 months|Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.|||participants|||Number
1260566|NCT00429026|Primary|Survival Rate|Number of participants surviving at 4 years compared to total participants, to compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. Evaulation after 1, 2, 3, 6, 9, & 12 months, then every 4 months for 4 years.|Up to 4 years|Primary outcome measure was not assessed due to early study termination, e.g. patients did not receive assigned treatment.||||||
1260567|NCT00428974|Secondary|Relationship Between Peripheral Blood Mononuclear Cell Adenosine A3 Receptor (A3AR) Expression Level at Baseline and Response to Therapy.|A3AR is measured biochemically and the expression level on cells from patients with disease is compared to that from healthy volunteer levels and expressed as a ratio|12 weeks|||||||
1260568|NCT00428974|Secondary|Individual PASI Components Redness, Thickness, and Scale|Each component is scored as 0 (clear, no disease) to 24 (most severe score); lower scores indicate improvement|12 weeks|||||||
1260569|NCT00428974|Secondary|"The Number of Patients Who Achieve a Score of Almost Clear or Clear by Physician's Global Assessment (PGA)"|PGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome|12 weeks||||Number of treated patients|||Number
1260570|NCT00428974|Primary|Frequency and Nature of Adverse Events||12 weeks|||||||
1260571|NCT00428974|Primary|Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score|PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement|12 weeks minus baseline||||Scores on a scale||Standard Deviation|Mean
1260572|NCT00428948|Secondary|Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36||Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants taking antihypertensive medication at Baseline with available data were included in the analysis.|||Percentage of participants|||Number
1260573|NCT00428948|Secondary|Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36|A hypertensive event was defined as a change from non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) status to 1 of 3 conditions: (1) High pre-hypertensive (systolic BP [sBP] > 129 mmHg and/or diastolic BP [dBP] > 84 mmHg), (2) hypertensive (sBP > 139 mmHg and/or dBP > 89 mmHg), or (3) requiring antihypertensive therapy.|Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only non-hypertensive participants with available data were included in the analysis.|||Events/100 follow-up years|||Number
1260574|NCT00428948|Secondary|Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36|Change from baseline in renal pain was assessed by a 0 to 10 pain scale as average area under the concentration-time curve (AUC) between baseline and the last trial visit or the last visit prior to initiating medical (eg, narcotic or anti-nociceptives [eg, tricyclic antidepressants]) or surgical therapy for pain. In the pain scale, score 0 represented no pain at all and score 10 represented the worst pain. A negative change score indicates less pain. AUC of renal pain was derived from renal pain scores within treatment period and was calculated using the trapezoidal rule, by dividing the number of days between the first and last assessment.|At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants with available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1260575|NCT00428948|Secondary|Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36|For participants who were non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) at baseline, mean arterial blood pressure was measured at scheduled clinic visits up to the point of exposure to antihypertensive therapy for any reason. The change in mean arterial blood pressure per year was based on the slope of blood pressure, obtained by regressing blood pressure against time by subject.|Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only non-hypertensive participants with available data were included in the analysis.|||mmHg||Standard Deviation|Mean
1260576|NCT00428948|Secondary|Change in Renal Function Per Year From Week 3 to Month 36|Renal function was assessed using serum creatinine measurements and was estimated using 1/serum creatinine. The formula for 1/serum creatinine is: 1/Pcr, where Pcr = serum creatinine concentration (mg/dL). The change in renal function per year was based on the slope of change, obtained by regressing renal function data against time by subject.|Week 3 to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants with available data were included in the analysis.|||(mg/mL)^-1 per year||Standard Deviation|Mean
1260577|NCT00428948|Secondary|Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36|These ADPKD events in the key secondary Outcome Measure were selected on the basis of their potential relationship to progressing cystogenesis. Reducing the rate of cyst development and expansion would likely slow the progression of ADPKD. The 4 events were: (1) Onset or progression of hypertension (someone is hypertensive if they have > 139 mmHg systolic blood pressure [BP], > 89 mmHg diastolic BP, or if they are taking antihypertensive medication at any BP level); (2) severe renal pain requiring medical intervention; (3) worsening albuminuria (by category, see below); and (4) worsening renal function, defined as a 25% decrease in 1/serum creatinine from Baseline. Albuminuria was assessed using spot urine albumin/creatinine ratio measurements (all measurements in mg/mmol). Categories included normal (< 2.8 female or < 2.0 male), microalbuminuria (2.8-28 female or 2.0-20 male), and overt proteinuria (> 28 female or > 20 male.|Baseline to Month 36|Intent-to-treat population: All randomized participants. Only participants with available data were included in the analysis.|||Events/100 follow-up years|||Number
1260578|NCT00428948|Primary|Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36|Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, blinded radiologists used proprietary software to measure the volume of both kidneys.|Baseline to Month 36|Intent-to-treat population: All randomized participants who had Baseline and post-baseline observations of total kidney volume. Only participants with available data were included in the analysis.|||Percentage change per year||Standard Deviation|Mean
1260579|NCT00428922|Secondary|Changes in CECs as Predictors of PFS and Clinical Benefit|Circulating endothelial cells (CECs) are to be collected day 1 prior to treatment and day 22 prior to treatment. These samples are to be collected at the PI‘s discretion based upon the availability of the cell processing laboratory, the patients will be informed when consented if the samples will collected or not.|Day 1 and Day 22|CEC data was not collected and available for analysis||||||
1260580|NCT00428922|Secondary|Overall Clinical Benefit Rate (CR+PR+SD)|Defined as best response of CR or PR or stable disease for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|at least 24 weeks||||percent of patients||95% Confidence Interval|Number
1260581|NCT00428922|Secondary|Changes in CTCs as Predictors of PFS and Clinical Benefit|Circulating tumor cells (CTCs) evaluated at baseline (day 1 of treatment) and after 1 treatment cycle (day 22 prior to cycle 2 treatment).|Day 1 and Day 22|Due to sample size, could not perform any statistical analysis to correlate the baseline CTCs with PFS and response rate. Samples only available for 50% of the patients.|||patients with detected CTCs|||Number
1260582|NCT00428922|Primary|Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.|The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.|up to 3 years||||months||95% Confidence Interval|Median
1260583|NCT00428844|Secondary|Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)|The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.|Day 4 (steady state)|Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.|||µg•hr/mL||Full Range|Median
1260584|NCT00428844|Secondary|Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)|The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.|Day 4 (steady state)|Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.|||µg/mL||Full Range|Median
1260585|NCT00428844|Secondary|Microbiological Response|Sponsor’s assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population.|Approximately 6 weeks post last dose (approximately week 12)|Modified Intent to Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.|||Participants|||Number
1260586|NCT00428844|Secondary|Overall Clinical Outcome|The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable.|Approximately 6 weeks post last dose (approximately week 12)|Modified Intent-to-Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.|||Participants|||Number
1260587|NCT00428844|Secondary|Safety - Notable Laboratory Abnormalities|Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range.|From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)|Safety Population|||Participants|||Number
1260588|NCT00428844|Primary|Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)|Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.|From the 3rd day of therapy to 1 week post last dose (approximately week 7)|Safety Population|||Participants|||Number
1260589|NCT00428792|Secondary|Clinical Global Impression (CGI-I) Scale Score – Physician Rating of Improvement (Change in State)|The CGI-I is a scale to assess improvement (change in state) of illness. The rating is based on the investigator answering one question: “Compared to the patient’s condition prior to medication, this patient’s condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.” The investigator compares the patient’s overall clinical condition to the 1 week period just prior to the initiation of medication.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Units on a scale||Standard Deviation|Mean
1260590|NCT00428792|Secondary|Clinical Global Impression Severity (CGI-S) Scale Score – Physician Rating of Severity|The CGI-S is a scale to assess the global severity of illness. The rating is determined by the investigator answering one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Ratings are on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The rating is based upon the average observed and reported symptoms, behavior, and function in the past 7 days.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
1260591|NCT00428792|Secondary|10-Minute Math Test – Problems Solved|The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to “academic productivity”. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Problems solved||Standard Deviation|Mean
1260592|NCT00428792|Secondary|10-Minute Math Test – Problems Attempted|The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to “academic productivity”. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Problems attempted||Standard Deviation|Mean
1260593|NCT00428792|Primary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Per protocol (PP) population: All patients in the ITT population who (a) met the inclusion/exclusion criteria liable to affect the efficacy assessment and (b) did not violate the protocol in a manner liable to affect the efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1260594|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
1260595|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating|Teacher rating of the hyperactivity subscale (4 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 4) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
1260941|NCT00426660|Secondary|Change From Baseline in CD4 Cell Count|Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||cells/uL||Standard Deviation|Mean
1260596|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating|Teacher rating of the hyperactivity subscale (7 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 7) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
1260597|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating|Teacher rating of the attention deficit subscale (9 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 9) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
1260598|NCT00428792|Primary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
1260599|NCT00428610|Other Pre-specified|Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment||Study treatment discontinuation up to 30 days post study treatment discontinuation|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
1260600|NCT00428610|Secondary|Number of Participants With Adverse Events (Safety)|Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.|First treatment dose up to 43.91 months|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
1260601|NCT00428610|Secondary|Duration of Stable Disease|Duration of stable disease is defined from date of documented stable disease (SD) or better to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression or death). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months|All participants who received at least one dose of the study drug and stable disease or better.|||months||90% Confidence Interval|Median
1260602|NCT00428610|Secondary|Duration of Response|The duration of response (complete response [CR] or partial response [PR]) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Time of response to time of measured progressive disease up to 12.68 months|All participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR).|||months||90% Confidence Interval|Median
1260603|NCT00428610|Secondary|Overall Survival|Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact.|First treatment to death due to any cause up to 42.91 months|All participants who received at least one dose of the study drug. The numbers of participants censored are 11 (Target Cmax 420 µg/mL group), 6 (Target Cmax 360 µg/mL group) and 14 (Albumin-Tailored Dose group).|||months||90% Confidence Interval|Median
1260604|NCT00428610|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY573636||Predose up to 2 hours postdose in Cycles 1 and 2|All participants who received at least one dose of the study drug and had pharmacokinetics data at the specified time points.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1260605|NCT00428610|Secondary|Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate)|Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated multiplied by 100.|Baseline to measured progressive disease up to 21.26 months|All participants who received at least one dose of the study drug.|||percentage of participants||90% Confidence Interval|Number
1260606|NCT00428610|Secondary|Progression Free Survival|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Baseline to measured progressive disease or death due to any cause up to 21.26 months|All participants who received at least 1 dose of the study drug.|||months||90% Confidence Interval|Median
1261231|NCT00424554|Primary|MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery|An experimental assay was developed to measure MGMT levels.|14 days|"All participants for which a MGMT activity assay could be~performed"|||fmol/mg of proteins||Standard Deviation|Mean
1260607|NCT00428610|Primary|Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)|Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Baseline to measured progressive disease up to 12.68 months|All participants who received at least one dose of the study drug.|||percentage of participants||90% Confidence Interval|Number
1260608|NCT00428597|Secondary|EORTC QLQ-C30 - Pain Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260609|NCT00428597|Secondary|EORTC QLQ-C30 - Nausea and Vomiting Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260610|NCT00428597|Secondary|EORTC QLQ-C30 - Insomnia Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260611|NCT00428597|Secondary|EORTC QLQ-C30 - Financial Difficulties Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260612|NCT00428597|Secondary|EORTC QLQ-C30 - Fatigue Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260613|NCT00428597|Secondary|EORTC QLQ-C30 - Dyspnea Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260614|NCT00428597|Secondary|EORTC QLQ-C30 - Diarrhea Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260623|NCT00428597|Secondary|Overall Survival (OS)|Time in months from time of randomization to date of death due to any cause. The median number of months is provided; however, the study was terminated early. OS data was not mature by the time of analysis. Median OS time cannot be accurately estimated by Kaplan-Meier method for either treatment arm.|From start of study treatment up to 22 months|ITT. The median OS in months could not be calculated for placebo.|||months||95% Confidence Interval|Median
1261265|NCT00424463|Secondary|Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group||36 weeks (from seventh cycle to fifteenth cycle)||||percentage of participant|||Number
1260615|NCT00428597|Secondary|EORTC QLQ-C30 - Constipation Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260616|NCT00428597|Secondary|EORTC QLQ-C30 - Appetite Loss Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260617|NCT00428597|Secondary|EORTC QLQ-C30 - Social Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260618|NCT00428597|Secondary|EORTC QLQ-C30 - Role Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260619|NCT00428597|Secondary|EORTC QLQ-C30 - Physical Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260620|NCT00428597|Secondary|EORTC QLQ-C30 - Emotional Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260621|NCT00428597|Secondary|EORTC QLQ-C30 - Cognitive Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles with less than 10 subjects are not reported due to lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260622|NCT00428597|Secondary|European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|Patient Reported Outcome (PRO) population=subjects from the ITT population who had completed at least 1 EORTC QLQ-C30 assessment while on treatment. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
1260640|NCT00428441|Secondary|Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy||3 months|||||||
1260641|NCT00428441|Primary|Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations||3 months|||||||
1260624|NCT00428597|Secondary|Time-to-Tumor Response (TTR)|Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.|From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter|ITT. TTR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for TTR; no placebo subjects reported CR or PR.|||Months||Full Range|Median
1260625|NCT00428597|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause|ITT. DR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for DR; no placebo subjects reported CR or PR.|||Months||Full Range|Median
1260626|NCT00428597|Secondary|Number of Subjects With Objective Response|Objective response = subjects with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) for at least 4 weeks, confirmed by repeat tumor assessments. A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter|ITT. No placebo subjects had objective response.|||participants|||Number
1260627|NCT00428597|Primary|Progression Free Survival (PFS)|Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.|From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death|Intent-to-treat (ITT) population = all subjects who were randomized.|||Months||95% Confidence Interval|Median
1260628|NCT00428584|Other Pre-specified|Primary Outcome - Extension Phase: Visual Analog Scale (VAS) of Patients Reported Pain; Change in Mean VAS at Pre-injection and 30 Minutes Post Injection||Pre-injection and 30 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase|||Millimeters||Full Range|Mean
1260629|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Diameter in Injection Site Redness||1 to 72 hours post injection|3 subjects discontinued and withdrew consent from the Betaseron to Rebif New Formulation Group in the Extension Phase|||Millimeters||Standard Deviation|Mean
1260630|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection||Pain free patients at 30 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase|||Participants|||Number
1260631|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection||Pre-injection and 10 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase|||Millimeters||Full Range|Mean
1260632|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.|Pre-injection and immediately after injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase|||millimeters||Full Range|Mean
1260633|NCT00428584|Secondary|Diameter of Injection Site Redness|Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection|1-72 hours post injection over the first 12 weeks including the titration period|One subject from the new formulation of rebif group discontinued due to pregnancy|||mm||Standard Deviation|Mean
1260634|NCT00428584|Secondary|Number of Pain Free Patients at 30 Minutes Post-injection|"A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used.~Pain-free was defined as a VAS score of 0 for all 21 full-dose injections for the Intent-to-Treat (ITT) population."|30 minutes post injection|One subject from the new formulation of rebif group discontinued due to pregnancy|||Participants|||Number
1260635|NCT00428584|Secondary|Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 10 minutes post injection.|Pre-injection to 10 minutes post-injection|One subject from the new formulation of Rebif group discontinued due to pregnancy|||Millimeters||Full Range|Mean
1260636|NCT00428584|Secondary|Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.|Pre-Injection to Immediately after Injection|One subject from the new formulation of rebif group discontinued due to pregnancy|||millimeters||Full Range|Mean
1260637|NCT00428584|Primary|Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints|Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection|From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron|One subject from the new formulation of rebif group discontinued due to pregnancy therefore, data for the Full Dose Calculation 30min Mean Change was not calculated|||mm||Full Range|Mean
1260638|NCT00428441|Secondary|Mortality||3 months|||||||
1260639|NCT00428441|Secondary|Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy||3 months|||||||
1260643|NCT00428389|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study|The ADCS-ADL scale is composed of 23 items to assess the basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, making judgments and decisions. Responses for each item are obtained through a caregiver interview. The total score is the sum of all items and sub-questions. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change from baseline indicates improvement.|Baseline, Week 25 (end of the extension phase) and at the end of Study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).|||Scores on a scale||Standard Deviation|Mean
1260644|NCT00428389|Secondary|Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.|The NPI-10 assesses a wide range of behavior problems encountered in dementia patients. The 10 behavioral domains comprising the NPI-10 are evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 10 domains yields the NPI total score, which ranges from 0 to 120, the lower the score the less severe the symptoms. A negative change score from baseline indicates improvement.|Baseline, Week 25 (end of the extension phase) and at End of Study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).|||Scores on a scale||Standard Deviation|Mean
1260645|NCT00428389|Secondary|Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline and Week 25 (end of the extension phase) and at the end of study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).|||Scores on a scale||Standard Deviation|Mean
1260646|NCT00428389|Secondary|Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25|The CGIC is an assessment tool used by a skilled clinician to make a judgment of the severity or a change of a patient’s condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The clinician does not have access to any post-baseline cognitive testing data. The CGIC is rated on a seven-point scale, ranging from (1) “very much improved” to (4) “no change” to (7) “very much worse”.|Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase)|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).|||Scores on a scale||Standard Deviation|Mean
1260647|NCT00428389|Secondary|Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase|A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to any reason during extension phases of the study.|From week 5 through the end of extension phase (25 weeks)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.|||Participants|||Number
1260648|NCT00428389|Secondary|Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study|A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer’s disease (AD) was the number of participants who discontinued from the study due to an AE during the combined core and extension phases of the study.|Baseline through the end of study (25 weeks)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.|||Participants|||Number
1260649|NCT00428389|Primary|Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study|The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer’s disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase.|Baseline through the end of the core phase of the study (Week 5)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.|||Participants|||Number
1260650|NCT00428298|Other Pre-specified|Change From Baseline in Young Mania Rating Scale (YMRS) at 16 Weeks|"The Young Mania Rating Scale has 11 items that rate the subject's subjective experience and clinician observation. Four items are rated 0-8, the remaining are rated 0-4.~The score can range from 0 to 60. A higher score indicates the presence of manic symptoms."|16 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.|||units on a scale||Standard Deviation|Mean
1260651|NCT00428298|Secondary|Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks|The MADRS is a 10 item depression rating scale administered by a research team member. The MADRS is composed of 10 items with a 7 point fixed rating scale (0-6). A higher score indicates the presence of depressive symptoms.|16 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.|||units on a scale||Standard Deviation|Mean
1261011|NCT00425945|Primary|Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.|Mean at Week 12 observation minus mean at Baseline observation.|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.|||mm Hg||95% Confidence Interval|Mean
1260652|NCT00428298|Primary|Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks|"The RBANS is a brief, independently administered measurement of cognitive decline or improvement.~The test is comprised of 12 subtests which comprise 5 domains. The age of the participant and the scores from each domain inform the total RBANS score (Index Score) analyzed in this study. The range for total score is 40-160. If the total score for a subject increases this denotes improved performance on the RBANS.~The RBANS was administered at baseline and 16 weeks."|16 weeks|Participants who completed screening/first visit Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and study completion/last visit RBANS. Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final RBANS scores. Imputed data was used for those participants.|||percentage of change||95% Confidence Interval|Mean
1260653|NCT00428246|Secondary|Effect of Paricalcitol on Kidney Function||6 weeks|||||||
1260654|NCT00428246|Secondary|Effect of Paricalcitol on Hypertension||6 weeks|||||||
1260655|NCT00428246|Primary|Endothelial Protectant Effects of Paricalcitol||6 weeks|||||||
1260656|NCT00428246|Primary|Anti-Inflammatory Effects of Paricalcitol|change in hsCRP level from baseline to 4 weeks|6 weeks||||micrograms||95% Confidence Interval|Mean
1260657|NCT00428220|Other Pre-specified|Summary of Duration of Clinical Benefit|Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.|From the first day of treatment in parent study until last day of treatment in A6181114 study.|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.|||Weeks||Standard Deviation|Mean
1260658|NCT00428220|Primary|Number of Participants With Treatment-emergent AEs (Treatment-Related)|Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.|From first day of treatment on the current study up to 28 days post the last dose of study treatment|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.|||participants|||Number
1260659|NCT00428220|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)|Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.|From first day of treatment on the current study up to 28 days post the last dose of study treatment|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.|||participants|||Number
1260660|NCT00428207|Secondary|Frequency of Catheter Change|Recorded by the subjects who will use a checklist to document the reason for the catheter change (routine, insufficient insulin in infusion system, unexplained hyperglycemia, catheter site irritation, suspected occlusion/kinking of catheter, loosening of catheter.|48 to 96 hours|Data collection was incomplete/insufficient and therefore end points could not be evaluated for this assessment.||||||
1260661|NCT00428207|Primary|Glycemic Stability|Glycemic stability will be assessed by MAGE (Mean Amplitude of Glycemic Excursion)(5), M value of Schlichtkrull, standard deviation & coefficient of variation using 7 point finger stick blood glucose measurements performed 48-96 hours after insertion of the pump infusion catheter. Data collected 48 to 72 hours post-catheter insertion will be analyzed separately from the data collected 72 to 96 hours post-catheter insertion. The mean of the measurements taken throughout the study will be used for calculation of the primary endpoint.|48 to 96 hours|"Data collection was incomplete/insufficient and therefore endpoint could not could not be evaluated"||||||
1260662|NCT00428116|Secondary|Morbidity|severe adverse events including death, pneumonia, diarrhea, and other adverse events|18 months post-randomization||||participants|||Number
1260663|NCT00428116|Primary|Growth at 18 Months Post-randomization|Weight and height will be transformed to the weight-for-age Z-score (i.e., WAZ) and height-for-age Z-score (i.e., HAZ) using World Health Organization Child Growth Standards, taking into account the infant's age and gender.|18 months of post-randomization follow-up||||z-score||Inter-Quartile Range|Median
1260664|NCT00428090|Secondary|Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment|Clinical chemistry parameters were identified as of PCC (H, L), if values were out of RR: Alanine aminotransferase (ALT, none-120 [250% upper limit of RR, ULRR]), Albumin (0.75-2), Aspartate aminotransferase (AST,none-105 (3-64y), 137.5 (65+y), >250%ULRR), Alkaline phosphatase (ALP,none-312.5 (20+y), >250%ULRR), blood urea nitrogen (BUN)/Creatinine ratio (none-1.25), BUN (none-11), Chloride (80-115), Calcium (0.75-1.25), Carbon dioxide (CO2, 15-40) content, Creatinine (22, <50% lower limit of RR [LLRR]-155, >125%ULRR), Creatine phosphokinase (CPK, none-1.25), Gamma glutamyl transferase (GGT,none-2.5), Glucose (3.6-7.8), High density lipoprotein (HDL,0.65-none), Lactate dehydrogenase (LDH,none-1.25), Low density lipoprotein (LDL,none-2), Magnesium (0.5-2), Potassium (3-5.5), Phosphorus inorganic (0.5-1.5), Sodium (130-150), Total protein (0.8-1.5), Total cholesterol (none-1.25), Total bilirubin (none-1.95), Triglycerides (none-9). Data for Creatinine clearance not reported.|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Participants|||Number
1260665|NCT00428090|Secondary|Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment|Haematology parameters were identified as of PCC (high [H], low [L]), if the values were out of the reference range (RR). The range for parameters was: platelet (100AV-500AV), red blood cell (RBC, 0.8-1.2), hemoglobin (L: female [F]:10, male [M]:11; H: F:16.5–AV, M:18), hematocrit (0.8-1.2), white blood cell (WBC, 3-15), neutrophils (0.75-1.5), lymphocytes (0.75-1.5), monocytes (0.75-2), eosinophils (none-2), basophils (none-2), mean corpuscle volume (MCV, 0.8-1.2), mean corpuscular hemoglobin (MCH, 0.8-1.2), mean corpuscular hemoglobin concentration (MCHC, 0.8-1.2), red cell distribution width (RDW, 0.8-1.2). Data for mean platelet volume (reference range not established) not reported|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Participants|||Number
1260666|NCT00428090|Secondary|Change From Baseline (W0) in Periodic HbA1c Assessment|HbA1c assessment was performed par. with type 2 diabetes mellitus or HbA1c >=6.5% at Screening only. HbA1c levels were assessed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Percentage||Standard Deviation|Mean
1260667|NCT00428090|Secondary|Change From Baseline (W0) in Hematocrit|Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Percentage of red blood cells in blood||Standard Deviation|Mean
1260668|NCT00428090|Secondary|Change From Baseline (W0) in Hemoglobin|Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Grams per liter (G/L)||Standard Deviation|Mean
1260669|NCT00428090|Secondary|Change From Baseline (W0) in Body Weight|Body weight will be measured at all visits, without shoes and wearing light clothing. The assessments was performed at Baseline, W4, W8, W12, W16, and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Kilogram (Kg)||Standard Deviation|Mean
1260670|NCT00428090|Secondary|Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG HR of Central Cardiologist reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Beats per minute||Standard Deviation|Mean
1260671|NCT00428090|Secondary|Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG parameters includes PR interval, QRS duration, QT – uncorrected interval, QTc Bazett (QTcB), QTc Fridericia (QTcF) and RR interval of Central Cardiologist are reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||milliseconds (MSEC)||Standard Deviation|Mean
1260672|NCT00428090|Secondary|Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).|SBP, DBP and HR of par. were recorded in sitting posture as vital signs, while body weight was measured without shoes and wearing light clothing at each visit. The blood pressure (BP) and HR values were identified as of PCC if the vales were out of the reference range (for SBP, 90 to 140 millimeters of mercury (mmHg), DBP, 50 to 90 mmHg, and HR >100 or <50 beats per minute [bpm]) or meet a change from Baseline criterion. For SBP it was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg; decrease from Baseline (low) if decreased by >=30 mmHg. For DBP, increase from Baseline (high) if increased by >=30 mmHg; decrease from Baseline (low) if decreased by >=20 mmHg. For HR, increase from Baseline (high) if increased by >=30 bpm; decrease from Baseline (low) if decreased by >=30 bpm. For weight, increase from Baseline (high) if increased by >=7%; decrease from Baseline (low) if decreased by >=7%. Baseline was defined as value at W0.|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Participants|||Number
1260673|NCT00428090|Secondary|Number of Participants With Adverse Events Defined by Severity|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE included significant or unexpected worsening or exacerbation of the condition/indication under study, exacerbation of a chronic or intermittent pre-existing condition, new conditions detected or diagnosed, signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concurrent medication. Number of participants with any AE and as per severity were reported. Refer to the general AE/SAE module for a list of AEs and SAEs.|Up to W24|Safety population: This included all par. randomized to treatment who have taken at least one dose of study medication.|||Participants|||Number
1260674|NCT00428090|Secondary|Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.|The blood sample was collected for assessments of HbA1c levels at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Percentage (%)||Standard Error|Least Squares Mean
1260699|NCT00427999|Secondary|Time to Progression-free Survival|Progression-free survival, defined as the time from first administration of study drugs to the first PSA value of a PSA non-responder. Responders will be censored with date of PSA response for the analysis. The median time to PSA progression free survival was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.|||days||95% Confidence Interval|Median
1261012|NCT00425854|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)|Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.|day 29||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1260675|NCT00428090|Secondary|Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.|The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale is completed by the investigator, based on the performance of the par. and takes approximately 5 to 10 minutes to administer. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived|Baseline (W0) and W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
1260676|NCT00428090|Secondary|Change From Baseline (W0) in Alzheimer’s Carer’s Quality of Life Instrument (ACQLI) Score at W12 and W24.|The ACQLI was an assessment of caregiver quality of life. This instrument consists of 30 questions exploring various aspects of carer’s quality of life. Each of the questions had a two point response and the 30 questions were summed to provide a total score. Items are assumed to be unidimensional (i.e., represent a single variable) and are scored 0/1 (false/true) before summation into a total score with a 0–30 range. To ease comparisons between scales, ACQLI scores were transformed to range between 0–100 (100: worse). The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
1260677|NCT00428090|Secondary|Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24|The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented par. RUD assess both formal and informal resource use of the par. and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 relates to assisting par. with basic activities of daily living and Q2 relates to instrumental activities of daily living. The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Hours||Standard Deviation|Mean
1260678|NCT00428090|Secondary|Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])|The EQ-5D Proxy is a 2 part scale used to assess the quality of life and utility benefit. The data for Part 2 is presented. It is a the visual analogue scale Thermometer which assessed caregiver's impression of par. overall health. The Thermometer has endpoints of 100 (best imaginable health state) and 0 (worst imaginable health state). EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
1260679|NCT00428090|Secondary|Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility|The EQ-5D Proxy was a 2 part scale used to assess the quality of life and utility benefit. The data for Part 1 is presented. It is a 5 dimensional Health State Classification. Caregivers were asked to respond as they feel the par. would on dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to each question were recorded on a 3-point scale which indicates the level of impairment (level 1= no problem; level 2=some or moderate problem(s) and level 3=unable, or extreme problem with higher scores indicating greater dysfunction. EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
1260680|NCT00428090|Secondary|Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24|Change from Baseline in short term memory assessment score was assessed from a combined analysis of items 1 (word recall task) and 7 (word recognition task) of ADAS-Cog scale. Word recall task consist of the participants score was the mean number of words not recalled on three trials (maximum score 10) and word recognition task, to score this item the number of incorrect responses was counted (maximum error score was 12). Higher score indicating greater dysfunction. Total score is sum of individual score. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
1260700|NCT00427999|Secondary|Time to PSA Response|Time to PSA response, defined as the time from first administration of study drugs to the first PSA value of a confirmed PSA response. Non-responders will be censored with date of final visit/premature discontinuation for the analysis. Median time to PSA response was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.|||days||95% Confidence Interval|Median
1260701|NCT00427999|Primary|PSA Response Rate|To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for > 5 ng/ml.|up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.|||participants|||Number
1260681|NCT00428090|Secondary|Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24|The DAD, assessed the ability of a par. to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. The percentage score was calculated as (DAD total score/total number of applicable items) multiplied by 100. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
1260682|NCT00428090|Secondary|Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24|The NPI assessed behavioral disturbances comprises 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety and aberrant motor activity. The par. caregiver asked about behavior in the par. If “Yes”, the informant then rates both the severity on a 3-point scale, 1: mild to 3: severe (total range: 0-36) and the frequency using a 4-point scale, 1: occasionally to 4: very frequently. The total domain score was frequency × severity. The distress was scored on 5-point scale, 0: no distress to 5 - very severe or extreme. A total NPI score can be calculated by adding all domain scores together; NPI total score: from 0-144 and NPI distress score: from 0-60, all with higher scores indicating more severe behavioral disturbance. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles). Endpoint treatment differences which were adjusted to take account of missing data are derived.|||Score on a scale||Standard Error|Least Squares Mean
1260683|NCT00428090|Secondary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means more dysfunction. The scale was based on interviews with the par. and caregiver and was completed by an independent rater. It required separate structured 15-20 minute interviews with the par. and caregiver. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. It was evaluated at Baseline, W8, W16 and W24.|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
1260684|NCT00428090|Secondary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Endpoint treatment differences were adjusted to take account of missing data. It was evaluated at Baseline, W8, W16 and W24.|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
1260685|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in full population.|||Score on a scale||Standard Error|Least Squares Mean
1260686|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4’s Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in all except e4/e4’s: comprised of APOE e4 neg par. (e2/e2, e2/e3, and e3/e3) and APOE e4 heterozygote par. (e2/e4, e3/e4)|||Score on a scale||Standard Error|Least Squares Mean
1260702|NCT00427973|Post-Hoc|Discontinued Treatment Due to SAE|Participants that discontinued treatment due to a Serious Adverse Event (SAE)|May 2009 through January 2010||||Participants|||Number
1260687|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in APOE e4 negative (neg) par. (e2/e2, e2/e3, and e3/e3).|||Score on a scale||Standard Error|Least Squares Mean
1260688|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population|||Score on a scale||Standard Error|Least Squares Mean
1260689|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4’s Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in all except e4/e4’s: comprised of APOE e4 neg par. (e2/e2, e2/e3, and e3/e3) and APOE e4 heterozygote par. (e2/e4, e3/e4)|||Score on a scale||Standard Error|Least Squares Mean
1260690|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted for APOE e4 negative (neg) par. (e2/e2, e2/e3, and e3/e3) cohort|||Score on a scale||Standard Error|Least Squares Mean
1260691|NCT00428077|Secondary|Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.||Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.|||||||
1260692|NCT00428077|Primary|Correlation of Response With Specific HLA Types||12-24 Months|||||||
1260693|NCT00428077|Primary|Immunologic Response Over 1 Year||12 months|||||||
1260694|NCT00428077|Primary|Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions||12-24 Months|||||||
1260695|NCT00428077|Primary|Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts||12-24 Months|||||||
1260696|NCT00428077|Primary|Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.|One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.|Every 3 months for the duration of the 1-year treatment period. .|Per protocol.|||Participants|||Number
1260697|NCT00427999|Secondary|Quality of Life Assessed With EORTC-30|Health-related quality of life was assessed with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-30) questionnaire and was presented descriptively. The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.|baseline and Final Visit (week 24)|Intent to Treat (ITT) includes the 61 patients treated|||scores on a scale||Standard Deviation|Mean
1260698|NCT00427999|Secondary|Overall Survival Rate|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. The median time to overall survival rate was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.|||days||95% Confidence Interval|Median
1261266|NCT00424463|Secondary|Percentage of Participants With Adverse Drug Reactions||36 weeks (from seventh cycle to fifteenth cycle)||||percentage of participant|||Number
1260704|NCT00427973|Secondary|Response Rate|"Number of patients who achieve either complete or partial response based on RECIST Criteria for target lesions assessed by MRI.~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|Up to 1 year|Patients receiving AZD2171 (cediranib maleate)|||participants with confirmed response|||Number
1260705|NCT00427973|Primary|Progression-free Survival|"Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first.~This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%."|3 months|The number of patients who were progression free at 3 months was determined. 13 of 17 patients (77%) were progression free at 3 months.|||percentage of participants||95% Confidence Interval|Number
1260706|NCT00427960|Secondary|The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.|"Risk categories are:~Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L~Patients are defined as symptomatic if they meet at least 1 of the following criteria:~History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg~Total risk is derived from age, sex, TC, systolic BP and smoking status."|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
1260707|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in ApoB/ApoA1 Ratio|||Number
1260708|NCT00427960|Secondary|The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in Non-HDL-C/HDL-C Ratio|||Number
1260709|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in TC/HDL-C Ratio|||Number
1260710|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in LDL-C/HDL-C Ratio|||Number
1260711|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in ApoA1|||Number
1260712|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in ApoB|||Number
1260713|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6)in Non-HDL-C|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in Non-HDL-C|||Number
1260714|NCT00427960|Secondary|The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L||6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
1260715|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in HDL-C|||Number
1260716|NCT00427960|Secondary|The Percentage Change From Baseline(week6) in TC|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in TC|||Number
1260717|NCT00427960|Secondary|The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.|"Risk categories are:~Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L~Patients are defined as symptomatic if they meet at least 1 of the following criteria:~History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg~Total risk is derived from age, sex, TC, systolic BP and smoking status."|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
1260718|NCT00427960|Secondary|The Percentage of Participants Reaching the Joint British Societies’ Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L||6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
1260719|NCT00427960|Secondary|The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L||6 weeks (Baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
1260720|NCT00427960|Primary|Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)|Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in LDL-C|||Number
1260721|NCT00427934|Secondary|Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1|PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.|||hr||Full Range|Median
1260722|NCT00427934|Secondary|Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1|Effect of maraviroc on the PK of MTX (comparison of Cmax of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.|||ng/mL||Standard Deviation|Geometric Mean
1260723|NCT00427934|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1|Effect of maraviroc on the PK of MTX (comparison of AUC0-4 of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.|||ng.hr/mL||Standard Deviation|Geometric Mean
1260724|NCT00427934|Secondary|Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.|Withdrawal due to lack of efficacy was collected based on the investigator’s judgement. Time to withdrawal was measured by the probability that a subject did not withdraw due to lack of efficacy by a particular visit. This was a statistical estimate (Kaplan-Meier Survival Analysis) of the probability that a participant would not withdraw due to lack of efficacy.|Weeks 1 to 12|FAS|||proportion|||Number
1260725|NCT00427934|Secondary|Number of Subjects With Withdrawal From Study Due to Lack of Efficacy|Withdrawal is the total number of withdrawals from the study. Withdrawal due to lack of efficacy was collected based on the investigator’s judgement.|16 weeks|FAS|||participants|||Number
1260726|NCT00427934|Secondary|Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12|The SF-36 v.2 (Acute version) [12] is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (mental component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.|Baseline, Weeks 4 and 12|FAS|||scores on a scale||Standard Error|Least Squares Mean
1260727|NCT00427934|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12|The SF-36 v.2 (Acute version) is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (physical component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.|Baseline, Weeks 4 and 12|FAS|||scores on a scale||Standard Error|Least Squares Mean
1260728|NCT00427934|Secondary|Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline|Maximum QTcB, QTcF, and QTc intervals were defined as 450 to < 480 msec, 480 to < 500 msec, or > = 500 msec.|Baseline, 16 weeks|FAS|||Participants|||Number
1260729|NCT00427934|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used.|Baseline, 16 weeks|FAS|||bpm||Standard Deviation|Mean
1260730|NCT00427934|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used. QTc interval was not measured for the PK populations.|Baseline, 16 weeks|FAS|||msec||Standard Deviation|Mean
1260731|NCT00427934|Secondary|Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Maximum increase from baseline in supine and standing systolic BP was > = 30 mmHg, and maximum increase from baseline in supine and standing diastolic BP was > = 20 mmHg.|Baseline, 16 weeks|FAS|||Participants|||Number
1260732|NCT00427934|Secondary|Change From Baseline in Mean Heart Rate|Heart rate = standing and supine at the same time the orthostatic BP measurements were obtained. Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were not used.|Baseline, 16 weeks|FAS|||beats per minute (bpm)||Standard Deviation|Mean
1260733|NCT00427934|Primary|American College of Rheumatology (ACR) 20% Responders at Week 12|A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient’s Assessment of Arthritis Pain (Visual Analogue Scale [VAS]), Patient’s Global Assessment of Arthritis (VAS), Physician’s Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire – Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) was defined as an intent-to-treat analysis set that included all subjects randomized to treatment who had taken at least 1 dose of study medication. Missing values were imputed by the method of last observation carried forward (LOCF).|||Participants|||Number
1260734|NCT00427934|Secondary|Change From Baseline in Mean Orthostatic Blood Pressure (BP)|Supine BP was recorded after 5 minutes lying down; subjects then sat for 2 minutes then stood for 2 minutes and standing BP was recorded. Orthostatic BP = either a systolic BP drop > 20 mmHg, or diastolic BP drop > 10 mmHg and/or drop in systolic BP < 90 mmHg. If a subject met the orthostatic criteria, they were required to complete 2 additional readings to provide a triplicate reading. The means of replicate BP values were used in the analysis. Baseline = the latest non-missing value from a range of pre-treatment visits. Change from baseline to Week 16 was analyzed for orthostatic BP.|Baseline, 16 weeks|FAS|||mmHg||Standard Deviation|Mean
1260830|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations were presented as micrograms per milliliter (μg/mL).|Prior to (PRE) and one month post vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1260735|NCT00427934|Secondary|Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12|"DAS28-4 (CRP) was calculated using the following formula:~DAS28- 4(CRP) = 0.56 √28 Tender Joint Count + 0.28 √28 Swollen Joint Count + 0.36*natural logarithm(CRP + 1) + 0.014*Patient Global Assessment + 0.96. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at each visit was analyzed for DAS28-4 (CRP). The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 DAS28-4 (CRP) data were collected, but not analyzed."|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||mg/L||Standard Error|Least Squares Mean
1260736|NCT00427934|Secondary|Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit were analyzed for CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 CRP data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||mg/L||Standard Error|Least Squares Mean
1260737|NCT00427934|Secondary|Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12|HAQ-DI assesses degree of difficulty experienced in daily activity categories (dressing/grooming, arising, eating, walking, hygiene, reach, grip and other activities) over the past week. There are 20 questions and difficulty is scored from 0 (none), 1 (some), 2 (much) and 3 (unable to do). Scores were then averaged to give the disability index (scale of 0 to 3). Change from baseline at each visit was analyzed. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 HAQ-DI data were collected but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS.|||scores on scale||Standard Error|Least Squares Mean
1260738|NCT00427934|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|Physician's evaluation based on subject’s disease signs, functional capacity and physical exam. Response recorded using 5-point scale: 1=Very Good, 2=Good, 3=Fair, 4=Poor and 5=Very Poor. Change from baseline at each visit was analyzed for Physician’s Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy thus Week 16 Physician's Global Assessment of Arthritis Pain data were collected but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||scores on scale||Standard Error|Least Squares Mean
1260739|NCT00427934|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|Subjects answered: “Considering all the ways your arthritis affects you, how are you feeling today?” Subjects responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. Change from baseline at each visit was analyzed for Patient’s Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Global Assessment of Arthritis Pain data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||scores on scale||Standard Error|Least Squares Mean
1260740|NCT00427934|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|The severity of arthritis was scored by the subject between 0 (no pain) and 100 (most severe pain) on a 100 mm VAS. Change from baseline at each visit was analyzed for Patient’s Assessment of Arthritis Pain. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Assessment of Arthritis Pain data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||scores on scale||Standard Error|Least Squares Mean
1260741|NCT00427934|Secondary|Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit was analyzed for swollen joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, MCP joints, PIP joints, and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 swollen joint count data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||joint count||Standard Error|Least Squares Mean
1260742|NCT00427934|Secondary|Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit was analyzed for tender/painful joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, metacarpophalangeal joints (MCP), proximal interphalangeal joints (PIP), and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 tender/painful joint count data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||joint count||Standard Error|Least Squares Mean
1260743|NCT00427934|Secondary|ACR 70% Responders at Weeks 1, 2, 4, 8, and 12|A subject was an ACR 70 responder if: the counts for both tender and swollen joints had reduced by 70% or more from baseline; and 3 out of the following 5 assessments showed reduction of 70% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 70% data were collected, but not analyzed.|Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||Participants|||Number
1260744|NCT00427934|Secondary|ACR 50% Responders at Weeks 1, 2, 4, 8, and 12|A subject was an ACR 50 responder if: the counts for both tender and swollen joints had reduced by 50% or more from baseline; and 3 out of the following 5 assessments showed reduction of 50% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 50% data were collected, but not analyzed.|Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||Participants|||Number
1260745|NCT00427934|Secondary|ACR 20% Responders at Weeks 1, 2, 4, and 8|A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 20% data were collected, but not analyzed.|Weeks 1, 2, 4, and 8|FAS. Missing values were imputed by the method of LOCF.|||Participants|||Number
1261267|NCT00424463|Secondary|Percentage of Participants With Adverse Events||36 weeks (from seventh cycle to fifteenth cycle)||||percentage of participant|||Number
1260746|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||Units on scale||Standard Deviation|Mean
1260747|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Presenteeism|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the ITT population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||Units on scale||Standard Deviation|Mean
1260748|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Absenteeism|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||units on a scale||Standard Deviation|Mean
1260749|NCT00427921|Secondary|Urinalysis - Change From Baseline to Final Visit|Changes from the Group mean at baseline are compared to the final visit Group mean value|Up to 24 weeks||||number||Standard Deviation|Mean
1260750|NCT00427921|Secondary|Clinical Chemistry - Change From Baseline to Final Visit|Changes from the Group mean at Baseline are compared to the final visit Group mean value|Up to 24 weeks||||number||Standard Deviation|Mean
1260751|NCT00427921|Secondary|Hematology - Change From Baseline to Final Visit|Changes from the Group mean at baseline are compared to the final visit Group mean value|Up to 24 weeks||||number||Standard Deviation|Mean
1260752|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment|"Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity).~Minimal clinically important difference = 7 points. Measure is Mean percent change."|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||Units on scale||Standard Deviation|Mean
1260753|NCT00427921|Secondary|50% Improvement in Draining Fistula Count and Fistula Healing|"Decrease in draining fistula is beneficial. 50 percent improvement refers to a reduction in the number of baseline fistula by 50 percent."|Week 12, Week 24, Last Assessment Value (last nonmissing value)|Intent To Treat|||participants|||Number
1260754|NCT00427921|Secondary|Employment Status: Number of Subjects Employed|Summary of employment status of those employed.|Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||participants|||Number
1260755|NCT00427921|Secondary|Overall Health Care Resource Utilization|"From the Overall Health Care Resource Utilization Questionnaire: Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization."|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||number of visits||Standard Deviation|Mean
1260756|NCT00427921|Post-Hoc|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline|Quality of life questionnaire for patients with IBD consisting of 4 domains: systemic, social, emotional, and bowel. This is a 10-item questionnaire, and all items are reported with a 7-point scale (ranging from 1 = poor HRQOL, to 7 = optimum HRQOL). Total SIBDQ score ranges from 10 (quality of life has been negatively affected tremendously by IBD) to 70 (quality of life is barely impacted by IBD). A change greater than 9 points was the minimal clinically important difference (MCID).|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||units on a scale||Standard Deviation|Mean
1260757|NCT00427921|Primary|Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.|Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||Percentage of injections||Standard Deviation|Mean
1260758|NCT00427921|Primary|Total Number of Injections of Adalimumab|Extent of exposure for all adalimumab treated subjects|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||injections||Standard Deviation|Mean
1260759|NCT00427921|Secondary|Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).|Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.|Week 12, Week 24, and Last Assessment Value (last nonmissing value)||||number of fistulas||Standard Deviation|Mean
1267510|NCT00380250|Secondary|Month 2 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
1260760|NCT00427921|Post-Hoc|Harvey-Bradshaw Index (HBI) Mean Change From Baseline|HBI score (range 0-30) sum subtotal of 5 parameters of subject's CD activity: a)Well being 0=very well-4=terrible b) Abdominal pain 0=none- 3=severe c) Number liquid stools per day d) Abdominal mass 0=none-3=tender e) Complications: 1 point each. Decrease indicates improvement. Absolute decrease of 3 units on scale is clinically important.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|Intent to Treat - subjects who received at least one dose of study drug.|||Units on scale||95% Confidence Interval|Mean
1260761|NCT00427921|Primary|Mean Extent of Exposure - Duration in Days|Extent of exposure for all adalimumab treated subjects|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||days||Standard Deviation|Mean
1260762|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months following vaccination up to Year 5|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260763|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months following vaccination up to Year 4|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260764|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months following vaccination up to Year 3|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260765|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months after vaccination up to Year 2|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260766|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months after vaccination up to Year 1|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260767|NCT00427908|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260768|NCT00427908|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260769|NCT00427908|Secondary|Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit|Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.|From administration of the vaccine dose until 6 months later|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260770|NCT00427908|Secondary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From administration of the vaccine dose until 6 months later|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260771|NCT00427908|Secondary|Number of Subjects With Rash|Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.|From administration of the vaccine dose until 6 months later|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260772|NCT00427908|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260773|NCT00427908|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - < 2 years of age and 2 - < 6 years of age groups) and 50 mm (6 - < 11 years of age groups) of injection site, respectively.|During the 4-day (Day 0-3) follow-up period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
1260774|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260775|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
1260776|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and at Persistence Year 5 [PI(M60)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260777|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
1260778|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260779|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
1260780|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals’ laboratory, on the ATP cohort for persistence Year 5.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260781|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals’ laboratory, on the ATP cohort for persistence Year 5.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
1260782|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals’ laboratory, on the ATP cohort for persistence Year 5.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260783|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals’ laboratory, on the ATP cohort for persistence Year 5.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
1260784|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260785|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
1260786|NCT00427908|Secondary|rSBA Antibody Titers (HPA Laboratory Assay)|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.|At Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260787|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.|At Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
1260788|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.|At Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
1260789|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.|At Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260790|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260791|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
1260792|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260793|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
1260794|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Titers||95% Confidence Interval|Geometric Mean
1261013|NCT00425854|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).|baseline till end of treatment||||participants|||Number
1260795|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Participants|||Count of Participants
1260796|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Participants|||Count of Participants
1260797|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and at Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260798|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260799|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Participants|||Count of Participants
1260800|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260801|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
1260802|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||μg/mL||95% Confidence Interval|Geometric Mean
1260803|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
1260804|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
1260805|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||μg/mL||95% Confidence Interval|Geometric Mean
1261088|NCT00425269|Secondary|Insulin, 0-h, Post-test||post-test, after completion of all six group sessions||||pmol/L||95% Confidence Interval|Mean
1260806|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260807|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was ≥ 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
1260808|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260809|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
1260810|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month after vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Titer||95% Confidence Interval|Geometric Mean
1260811|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value|The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
1260812|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260813|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
1260814|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as GMCs and expressed in μg/mL.|Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||μg/mL||95% Confidence Interval|Geometric Mean
1260815|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
1260816|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||μg/mL||95% Confidence Interval|Geometric Mean
1260817|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
1261089|NCT00425269|Secondary|C-peptid, 2-h, Post-test||post-test, after completion of all six group sessions||||pmol/L||95% Confidence Interval|Mean
1260818|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Titers||95% Confidence Interval|Geometric Mean
1260819|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
1260820|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Titer||95% Confidence Interval|Geometric Mean
1260821|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
1260822|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE) and one month post vaccination [PI(M1)]|The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1260823|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260824|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1260825|NCT00427908|Secondary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260826|NCT00427908|Secondary|Anti-TT Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month post vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1260827|NCT00427908|Secondary|Number of Subjects With Anti-TT Antibody Concentrations|Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260828|NCT00427908|Secondary|Anti-TT Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1260829|NCT00427908|Secondary|Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1261090|NCT00425269|Secondary|C-peptid, 0-h, Post-test||post-test, after completion of all six group sessions||||pmol/L||95% Confidence Interval|Mean
1260831|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260832|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1260833|NCT00427908|Secondary|Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260834|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals’ laboratory.|Prior to (PRE) and one month post vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1260835|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values|The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260836|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1260837|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260838|NCT00427908|Primary|Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|One month after vaccination [PI(M1)]|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Percentage||95% Confidence Interval|Number
1260839|NCT00427908|Primary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|One month after vaccination [PI(M1)]|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260840|NCT00427908|Primary|Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) to vaccination|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Percentage||95% Confidence Interval|Number
1260841|NCT00427908|Primary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) vaccination|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260942|NCT00426660|Secondary|Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL|Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of participants|||Number
1260842|NCT00427908|Primary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response|"Vaccine response was defined as:~for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32~for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination."|One Month after vaccination|The analysis was performed on subjects of 2 years and above from the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1260843|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2|Systemic events reported using an electronic diary. Systemic events are any fever >=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.|Within 14 days after vaccination 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants||95% Confidence Interval|Number
1260844|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1|Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.|Within 14 days after vaccination 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants||95% Confidence Interval|Number
1260845|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants||95% Confidence Interval|Number
1260846|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation [lim] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants||95% Confidence Interval|Number
1260847|NCT00427895|Secondary|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination|Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|One month after vaccination 1 and One month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population; n= number of participants with a determinate IgG concentration to the given serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1260848|NCT00427895|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population; n= number of participants with valid and determinate assay results for the specified serotype at both sampling times.|||Fold Rise||95% Confidence Interval|Geometric Mean
1260863|NCT00427778|Secondary|Score on Question 3 of UDI 6|"Score (0-3) of response to question #3 (stress incontinence specific) of Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Question three asks specifically about Leakage related to activity, coughing, or sneezing, i.e. stress urinary incontinence. Answer is scored from 0-3 (3 most bothersome)."|4 weeks||||units on a scale||Inter-Quartile Range|Median
1261001|NCT00425945|Secondary|Weight|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||lb||Standard Deviation|Mean
1261091|NCT00425269|Secondary|HbA1C, Post-test||post-test, after completion of all six group sessions||||percent of Hb||95% Confidence Interval|Mean
1260849|NCT00427895|Secondary|Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|One month after vaccination 1|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||Percentage of participants||95% Confidence Interval|Number
1260850|NCT00427895|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group|Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination 1 and One month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||titers||95% Confidence Interval|Geometric Mean
1260851|NCT00427895|Primary|Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1|For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|One month after vaccination 1|Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.|||percentage of participants||95% Confidence Interval|Number
1260852|NCT00427895|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1|Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination 1|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||titer||95% Confidence Interval|Geometric Mean
1260853|NCT00427804|Primary|Fractional Absorption of Calcium|Fractional absorption of calcium (see citation for complete details)|7 week||||Percentage of absorption|||Number
1260854|NCT00427804|Primary|Intestinal Absorption of Calcium||12 Weeks|||||||
1260855|NCT00427791|Secondary|Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days|Number of participants with incidence of acute graft versus host disease (aGVHD) during first 100 days following transplant.|During the first 100 days following transplant|Analysis was by protocol.|||participants|||Number
1260856|NCT00427791|Primary|Progression-free Survival (PFS)|Time from randomization to first progression or death, whichever comes first, measured in months.|2 Years post transplant or until disease progression or death|Analysis was by protocol. Participants were randomized between Etoposide + Total body irradiation and Etoposide + Total body irradiation + Rituximab using a Bayesian adaptive algorithm.|||Months||Standard Deviation|Median
1260857|NCT00427778|Secondary|Post Void Residual|Post void residual measured by catheter after free flow uroflowmetry|"The UDS while wearing the ring was done 2-4 weeks into the 'ring' treatment period, at patient's convenience, the UDS done at baseline was considered representative of no treatment UDS."|All uroflow were obtained on arrival of the patient in the UDS suite and prior to instrumentation. patients were asked to arrive with a full bladder, but some did not, explaining the lower number of women with available results.|||ml||Standard Deviation|Mean
1260858|NCT00427778|Secondary|Patient Acceptability (10 cm VAS)|participants completed a 10 cm visual analogue scale at the end of 4 weeks of ring use, rating their pelvic discomfort on a 10 cm scale; 0= none, 10= max.|4 weeks|Women did not fill out this VAS when not wearing the incontinence ring.|||cm||Standard Deviation|Mean
1260859|NCT00427778|Secondary|Impact on I-QOL|The I-QOL (Incontinence-Quality of Life) is a valid and reproducible self-administered measure for assessing quality of life of patients with urinary incontinence. Items are scored on a 4-point Likert response scale (very much, moderately, a little, not at all). Scoring the I-QOL questionnaire involves summing the responses into a single score. The sum score is transformed to a 0-100 scale, with a higher number representing a better quality of life|4 weeks||||units on a scale||Inter-Quartile Range|Median
1260860|NCT00427778|Secondary|Urodynamic Effect of the Incontinence Ring on Flow Rate|Peak flow rate (ml/sec) during uninstrumented uroflow. The 'no treatment' flow rate was obtained during baseline urodynamic studies (UDS) and the 'incontinence ring' flow rate was obtained at the end of the ring period for each participants, while wearing the ring.|baseline and at 4 weeks of ring use.||||ml/sec||Standard Deviation|Mean
1260861|NCT00427778|Secondary|Objective Cure Rate|Number of Participants Without Urinary Stress Incontinence During Provocation testing during urodynamic studies (UDS). Provocations included valsalva and cough, first at 300 ml while lying then standing, followed, if no leakage was seen, to provocations at maximum cystometric capacity while standing.|4 weeks||||Participants|||Count of Participants
1260862|NCT00427778|Secondary|UDI Overall Score|Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Answers are scored from 0-3 (3 most bothersome). An average score is then obtained, ranging from 0-3.|4 weeks||||units on a scale||Inter-Quartile Range|Median
1260906|NCT00426842|Primary|Systolic Blood Pressure|brachial artery systolic blood pressure (mmHg)|The difference between the average supine systolic blood pressure and the average systolic blood pressure at 45 degree head-up tilt position.||||mmHg||Standard Deviation|Mean
1260864|NCT00427778|Primary|Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week|number of women who experienced 50% or more reduction in number of incontinence episode per week on diary while using the incontinence ring, compared to baseline period.|baseline and 4 weeks|All participants who were randomized and fitted with a ring are included in this intent to treat analysis. Patients for whom a ring could not be successfully fitted were considered failure (<50%) improvement)|||Participants|||Count of Participants
1260865|NCT00427765|Primary|Average Overall Survival Time|Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.|Baseline(transplantation) to disease progression or death for any reason, up to 6 years.|Analysis by protocol|||years||Full Range|Mean
1260866|NCT00427700|Secondary|Serum Levels of Progesterone|The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation.|8-10 days after ovulation|Intention to treat.Cases that were lost to follow-up observation, dropped out of the study, failed to collect progesterone on days 22 to 24, and lacked menses after medroxyprogesterone acetate treatment were considered as failures according to the intention-to-treat analysis.|||ng/mL||95% Confidence Interval|Mean
1260867|NCT00427700|Primary|Percentage of Participants With Ovulation Detected by Ultrasound|Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure.|cycle day 14-20|intention to treat.|||percentage of participants||95% Confidence Interval|Number
1260868|NCT00427661|Secondary|Incidence of Grade 2-4 Acute GVHD.||100 days||||participants with grade 2-4 AGVHD|||Number
1260869|NCT00427661|Primary|Engraftment at 1 Year Post BMT.|Measurement of total PBMC chimerism|1 year||||participants|||Number
1260870|NCT00427661|Primary|Development of GVHD Within 1 Year of BMT|GVHD is assessed by physical exam, bloodwork and biopsy.|1 year||||participants|||Number
1260871|NCT00427635|Secondary|Change From Baseline in Percentage Time With pH Within 4.0-6.9|Percentage time with pH 4.0-6.9 during 24-hour pH monitoring|Baseline and end of treatment (10-14 days)||||Percentage||Standard Deviation|Mean
1260872|NCT00427635|Secondary|Change From Baseline in Percentage Time With pH<4.0|Percentage time with pH<4 during 24-hour pH monitoring|Baseline and end of treatment (10-14 days)||||Percentage||Standard Deviation|Mean
1260873|NCT00427635|Secondary|Change From Baseline in Mean Acid Clearance Time|Based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Seconds||Standard Deviation|Mean
1260874|NCT00427635|Secondary|Change From Baseline in Mean Bolus Clearance Time|Based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Seconds||Standard Deviation|Mean
1260875|NCT00427635|Secondary|Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
1260876|NCT00427635|Secondary|Change From Baseline in Number of Liquid Acidic Reflux Episodes|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
1260877|NCT00427635|Secondary|Change From Baseline in Number of Non Acidic Reflux Episodes|Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
1260878|NCT00427635|Secondary|Change From Baseline in Number of Weakly Acidic Reflux Episodes|Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
1260879|NCT00427635|Secondary|Change From Baseline in Number of Acidic Reflux Episodes|Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
1260880|NCT00427635|Secondary|Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
1260881|NCT00427635|Secondary|Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux|Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.|Baseline and end of treatment (10-14 days)||||Mean Number of Events||Standard Deviation|Mean
1260882|NCT00427635|Primary|Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring|The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.|Baseline and end of treatment (10-14 days)||||Mean Number of Events||Standard Deviation|Mean
1260883|NCT00427557|Primary|Number of Participants With Engraftment|Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L; assessed from baseline to 100 days post-engraftment.|Baseline to 100 days post-engraftment|Analysis per protocol.|||participants|||Number
1260884|NCT00427349|Secondary|Objective Response Rate|Tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by the total number of analyzable patients. CR is defined as complete disappearance of all tumor lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician, assessed up to 5 years||||percentage of participants||90% Confidence Interval|Number
1260885|NCT00427349|Secondary|Overall Survival|Overall survival (OS) is defined as the time from registration until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method , with 95% confidence intervals calculated using Greenwood’s formula|assessed every 3 months if patient is < 2 years from study entry, then every 6 months up to 5 years|All eligible and treated patients|||months||95% Confidence Interval|Median
1260886|NCT00427349|Primary|Four-month Progression-free Survival Rate|Four-month progression-free survival (PFS) rate is defined as number of patients who are still progression free at 4 months after study entry divided by number of eligible and treated patients enrolled to the study. Progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), or unequivocal progression of existing non-target lesions.|assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four|The analysis population includes all 44 eligible and treated patients. But 2 patients did not have disease assessment after study entry and are excluded from the analysis.|||percentage of participants||90% Confidence Interval|Number
1260887|NCT00427336|Primary|Number of Patients With Engraftment Response|Engraftment defined as (1) the first of three consecutive days of an Absolute neutrophil count (ANC) >500/mL (b) the first of seven consecutive days of an unsupported platelet count 20,000. Patient needs to survive at least 28 days to be evaluable for engraftment. Chimerism studies need to demonstrate donor-derived hematopoiesis (>90%)|First 100 days post transplant.||||Participants|||Number
1260888|NCT00427297|Secondary|Incidence of Severe Adverse Events (Excluding Mortality)||2 years|15.6 person-years of follow-up overall at time of DSMB closure of study|||event|||Number
1260889|NCT00427297|Primary|Viral Failure|Virologic treatment failure was defined as follow-up (at least 24 weeks after enrollment date) viral load > 400 copies.|2 years|15.6 person years of follow-up overall at time of DSMB closure of study|||Participants|||Count of Participants
1260890|NCT00427297|Primary|Immunologic Failure|Immunologic treatment failure was defined as CD4% dropping below 15%, after a previous result greater than or equal to 15% (following along WHO Guidelines).|2 years|15.6 person years of follow-up overall at time of DSMB closure of study|||Participants|||Count of Participants
1260891|NCT00427297|Primary|Incidence of Mortality|Death during follow-up|2 years|Analysis was conducted at DSMB termination of study with 15.6 person-years of follow-up time in the cohort overall; 8.5 person-years in NVP-containing and 7.1 person-years in NVP-sparing arm.|||Participants|||Count of Participants
1260892|NCT00427193|Other Pre-specified|Change in Fat Mass|Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.|baseline, 12 months||||Kg||Standard Deviation|Mean
1260893|NCT00427193|Other Pre-specified|Change in Fat Mass|Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.|change 0 to 24 months||||kg||Standard Deviation|Mean
1260894|NCT00427193|Secondary|Change in Tumor Necrosis Factor-α (TNF-α), Baseline to 12 Months||change baseline to 12 months||||pg/mL||Standard Deviation|Mean
1260895|NCT00427193|Primary|Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition||Baseline, 24 months||||Kcal/day||Standard Deviation|Mean
1260896|NCT00427193|Primary|Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition, Baseline to 12 Months||Baseline, 12 months||||Kcal/day||Standard Deviation|Mean
1260897|NCT00427193|Primary|Change in Core Temperature, Baseline to 24 Months||Baseline to 24 months||||degrees Celsius||Standard Deviation|Mean
1260898|NCT00427193|Primary|Change in Core Body Temperature, Baseline to 12 Months||Baseline to 12 months||||degrees Celsius||Standard Deviation|Mean
1260899|NCT00427037|Primary|25-hydroxyvitamin D|25-hydroxyvitamin D measured in serum by ELISA|3 months||||ng/mL||95% Confidence Interval|Mean
1260900|NCT00427037|Secondary|Bone Turnover Marker-CTX|Blood levels of C-telopeptide|12 weeks||||pg/mL||95% Confidence Interval|Geometric Mean
1260901|NCT00427011|Secondary|Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|The UPDRS is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.|||scores on a scale||Standard Deviation|Mean
1260902|NCT00427011|Secondary|Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study|Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.|||scores on a scale||Standard Deviation|Mean
1260903|NCT00427011|Secondary|Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.|||hours||Standard Deviation|Mean
1260904|NCT00427011|Primary|Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.|||hours||Standard Deviation|Mean
1260905|NCT00426855|Primary|Optimal Bendamustine Dosage for Further Studies||Three weeks after treatment termination||||mg/m^2|||Number
1261092|NCT00425269|Primary|Plasma Glucose, 2-h, Post-test||post-test||||mmol/L||95% Confidence Interval|Mean
1260907|NCT00426764|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG scale is as follows:~Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.~Data reported is the shift from Baseline ECOG score to best on-study assessment score."|From Baseline to 31 March 2010 (up to 33.4 months).|Safety population.|||participants|||Number
1260908|NCT00426764|Secondary|Time to Disease Progression|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.|||Days||95% Confidence Interval|Median
1260909|NCT00426764|Secondary|Duration of Complete Disease Response|Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population with a complete response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.|||days||95% Confidence Interval|Median
1260910|NCT00426764|Secondary|Duration of Objective Disease Response|Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.|||days||95% Confidence Interval|Median
1260911|NCT00426764|Secondary|Percentage of Participants With Objective Disease Response|Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses & extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histologically Confirmed Population. Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.|||percentage of participants||95% Confidence Interval|Number
1260912|NCT00426764|Primary|Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee|Complete Response (CR): >75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed >75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by >75% in their SPD.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.|||percentage of participants||95% Confidence Interval|Number
1260913|NCT00426751|Secondary|Mean Duration of Stay in the Ward|Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.|until 6 months after index-MI|ITT Population|||days||Standard Deviation|Mean
1260914|NCT00426751|Secondary|Number of Participants With Minor Bleedings (TIMI Classification)|The number of participants with minor bleedings (according to TIMI classification: clinically overt bleeding [e.g., gross haematuria or haematemesis) associated with a drop in haematocrit of ≥ 9% or a drop in haemoglobin of ≥ 3 g/dL) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population|||participants|||Number
1260915|NCT00426751|Secondary|Number of Participants With Major Bleedings (TIMI Classification)|Number of participants with major bleedings (according to TIMI classification: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population|||participants|||Number
1260916|NCT00426751|Secondary|Number of Participants With Heart Failure Until 6 Months After PCI|The number of participants with heart failure within 6 month after PCI was measured.|until 6 Months (Day 180) after index-MI|Safety Population|||participants|||Number
1261093|NCT00425269|Primary|The Fasting Plasma Glucose, Post-test||post-test||||mmol/L||95% Confidence Interval|Mean
1260918|NCT00426751|Secondary|Number of Participants Who Experienced Stroke or Major Bleeding Complications|Number of participants who experienced stroke (hemorrhagic, non-hemorrhagic) or major bleedings (TIMI class: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL).|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population|||participants|||Number
1260919|NCT00426751|Secondary|Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)|The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population|||participants|||Number
1260920|NCT00426751|Secondary|Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)|The number of participants who died, experienced re-MI, or experienced UTVR (necessity of re-PCI of the target vessel or coronary artery bypass graft [CABG] because of recurrent ischaemic angina within 30 days after PCI) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population: All participants who received at least one dose of study medication.|||participants|||Number
1260921|NCT00426751|Secondary|Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI|The number of participants with the indicated myocardial blush grade (TMPG), used to assess the myocardial reperfusion in the infarcted myocardium following PCI (as assessed by the core angiography laboratory), was measured. Blush grades: 0 = failure of dye to enter the microvasculature; 1 = dye slowly enters but fails to exit the microvasculature; 2 = delayed entry and exit of dye from the microvasculature; 3: normal entry and exit of dye from the microvasculature. Blush that is of only mild intensity throughout the washout phase but fades minimally is also classified as grade 3.|after PCI|ITT Population|||participants|||Number
1260922|NCT00426751|Secondary|Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI|cTIMI frame counts (number of cineframes needed for dye to reach standardized distal landmarks in a coronary vessel; objective index of coronary blood flow) following PCI, as assessed by core angiography lab.|after PCI|ITT Population. Participants with un-evaluable angiographies were excluded from analysis.|||number of frame counts||Standard Deviation|Mean
1260923|NCT00426751|Secondary|Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI|The number of participants with TIMI grade 3 (complete perfusion) patency of the infarcted vessels following PCI, as assessed by core angiography lab, was measured.|after PCI|ITT Population|||participants|||Number
1260924|NCT00426751|Secondary|Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI|Number of participants with the respective patency of the infarcted vessels was evaluated by TIMI (Thrombolysis In Myocardial Infarction) flow grades (Grade 0 = No perfusion, Grade 1 = Penetration with minimal perfusion, Grade 2 = Partial perfusion, Grade 3 = Complete perfusion), as assessed by core angiography lab.|immediately before PCI|ITT Population|||participants|||Number
1260925|NCT00426751|Secondary|Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI|Max STE is measured similarly to single-lead STR, but was not compared with the ST deviation on the baseline ECG I. It was the existing ST deviation on the single ECG lead of maximum ST deviation present at 60 minutes after the PCI (ECG III).|60 min +/- 15 min after PCI (ECG III)|ITT Population. Participants with unevaluable ECGs were excluded from analysis.|||millimeters (mm)||Standard Deviation|Mean
1260926|NCT00426751|Secondary|Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI|Mean sum STR was calculated as the difference between baseline (ECGI) and ECG II: the mean of the sum of ST elevation resolution from all ECG leads associated with infarct location. ST resolution was expressed as a percentage from baseline.|Baseline (ECG I) and immediately prior to PCI (ECG II)|ITT Population. Participants who did not have an ECG II immediately before PCI were excluded from analysis.|||percent change||Standard Deviation|Mean
1260927|NCT00426751|Secondary|Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI|Single lead STR is calculated as the difference between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1 -V4), whichever lead showed the largest deviation either at baseline or at follow-up, respectively. STR was expressed as a percentage from baseline.|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population. Participants with unevaluable ECGs were excluded from analysis.|||percent change||Standard Deviation|Mean
1260928|NCT00426751|Secondary|Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI|Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline.|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population. Some participants were un-evaluable with regard to the primary endpoint and were counted as failures. These participants were excluded from this analysis.|||percent change||Standard Deviation|Mean
1260929|NCT00426751|Secondary|Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI|Single lead STR is calculated as the difference (as a percentage) between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1- V4), whichever lead showed the largest deviation either at baseline or at ECG III, respectively (Complete: ≥ 70%; Partial: ≥ 30% and <70%).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population|||participants|||Number
1260930|NCT00426751|Secondary|Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI|Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline (Complete: ≥ 70% resolution; Partial: ≥ 30% and < 70% resolution; None: < 30% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population|||participants|||Number
1261002|NCT00425945|Secondary|Body Mass Index|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||kg/m^2||Standard Deviation|Mean
1261094|NCT00425269|Secondary|Intake of Fish, Baseline||baseline||||portions/week||Inter-Quartile Range|Mean
1260931|NCT00426751|Primary|Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)|Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.|||participants|||Number
1260932|NCT00426751|Primary|Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)|Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|Per Protocol (PP) Population: All randomized participants who received at least one dose of study drug, who had data that were fully evaluable for the primary endpoint, and who did not show any major protocol violation.|||participants|||Number
1260933|NCT00426660|Secondary|Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)|Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre-­treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV-­1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.|Baseline up to Week 144|"Safety analysis set. Here, number of participants analyzed signifies those participants who were assessed for genotypic changes in the V3 Loop of glycoprotein 120 (gp 120)."|||participants|||Number
1260934|NCT00426660|Secondary|Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau|Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on-­treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.|Baseline up to Week 144|"Safety analysis set. Here, number of participants analyzed signifies those participants who were assessed for maraviroc susceptibility."|||participants|||Number
1260935|NCT00426660|Secondary|Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure|Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.|Screening up to Week 144|Safety analysis set; N = participants with virologic failure (VF). Abbreviations: Scr = screening, R5 = CCR5 tropic HIV-1, X4=CXCR4 tropic HIV-1, DM = dual mixed, NR = non-reportable, Missing = participants with VF who did not have tropism result within specified screening period (Scr missing: -42 days to Day 0) or at the time of VF.|||percentage of participants|||Number
1260936|NCT00426660|Secondary|Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure|Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 144|Safety analysis set; N = number of participants with virologic failure.|||percentage of participants|||Number
1260937|NCT00426660|Secondary|Median Time to Virologic Failure|Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.|Day 1 up to Week 144|Safety analysis set. N = number of participants with virologic failure. For the calculation of the time to virologic failure, any visits with no data were excluded. Participants who were not virologic failures were censored at the last available observation.|||days||Inter-Quartile Range|Median
1260938|NCT00426660|Secondary|Change From Baseline in CD8 Cell Count Percent|Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of lymphocytes||Standard Deviation|Mean
1260939|NCT00426660|Secondary|Change From Baseline in CD8 Cell Count|Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||cells/uL||Standard Deviation|Mean
1260940|NCT00426660|Secondary|Change From Baseline in CD4 Cell Count Percent|Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of lymphocytes||Standard Deviation|Mean
1261003|NCT00425945|Secondary|C-reactive Protein|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.|||nmol/L||Standard Deviation|Mean
1260943|NCT00426660|Secondary|Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL|Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of participants|||Number
1260944|NCT00426660|Secondary|Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA|Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of participants|||Number
1260945|NCT00426660|Secondary|Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)|"Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels.~Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference."|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of participants|||Number
1260946|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status|Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events. Abbreviations: HBV = hepatitis B virus, HBC = hepatitis C virus.|||percentage of participants|||Number
1260947|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age|Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.|||percentage of participants|||Number
1260948|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race|Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.|||percentage of participants|||Number
1260949|NCT00426660|Primary|Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender|Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.|||percentage of participants|||Number
1260950|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study by time on therapy were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.||||||
1260951|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline/nadir CD4 cell counts were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.||||||
1260952|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline viral load were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.||||||
1260953|NCT00426660|Primary|Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses|Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.|Baseline up to Week 144|Safety analysis set.|||percentage of participants|||Number
1260954|NCT00426660|Primary|Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities|Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.|Baseline up to Week 144|Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.|||percentage of participants|||Number
1260955|NCT00426660|Primary|Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities|Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.|Baseline up to Week 144|Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.|||percentage of participants|||Number
1260956|NCT00426660|Primary|Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)|AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.|Baseline up to Week 144|Safety analysis set: all participants who were randomized and received at least one dose of study medication.|||percentage of participants|||Number
1261095|NCT00425269|Secondary|Intake of Poultry, Baseline||baseline||||portions/week||Inter-Quartile Range|Mean
1260957|NCT00426556|Secondary|Phase II: Overall Survival (OS)|Overall survival (OS) is defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.|every 3 months until death|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.|||Months||95% Confidence Interval|Median
1260958|NCT00426556|Secondary|Phase II: Progression Free Survival (PFS)|PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.|||Months||95% Confidence Interval|Median
1260959|NCT00426556|Secondary|Phase I: Best Overall Response (BOR)|BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR or SD >= 24 weeks).CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for partial disease (PD). PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.|||Percentage of Participants|||Number
1260960|NCT00426556|Primary|Phase II: Overall Response Rate|The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.|||Percentage of Participants|||Number
1260961|NCT00426361|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)|Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).|||Participants|||Count of Participants
1260962|NCT00426361|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)|Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).|||Participants|||Count of Participants
1260963|NCT00426361|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day period (Day 0-29) following vaccination||||Participants|||Count of Participants
1260964|NCT00426361|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria."|During the 7-day period (Day 0-6) following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1260965|NCT00426361|Secondary|Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)|"Booster response to PT, FHA and PRN were defined as:~For initially seronegative subjects [pre-vaccination titer below cut-off value of 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)]: antibody titers at least 4 times the cut-off,~For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,~For initially seropositive subjects with pre-vaccination titer above 20 EL.U/mL: an increase in antibody titers of at least 2 times the pre-vaccination titer."|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||Participants|||Count of Participants
1261004|NCT00425945|Secondary|Lipoprotein A|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). Calculated as (Pinebark_Followup - Pinebark_Baseline) - (Placebo_Follow-up - Placebo_Baseline)|three months||||nmol/L||Standard Deviation|Mean
1261005|NCT00425945|Secondary|HDL Particle Size|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||nm||Standard Deviation|Mean
1260966|NCT00426361|Secondary|Number of Subjects With Booster Response to Diphtheria and Tetanus|"Booster responses to diphtheria and tetanus were defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off value of 0.1 International Units per Milliliter): antibody titers at least four times the cut-off (post-vaccination titer greater than or equal to 0.4 IU/mL), and~For initially seropositive subjects (pre-vaccination titer greater than or equal to 0.1 IU/mL): an increase in antibody titers of at least four times the pre-vaccination titer."|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||Participants|||Count of Participants
1260967|NCT00426361|Secondary|Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are given as Geometric Mean Titers (GMTs). The titer is a serum dilution giving 50 percent reduction of signal compared to control without serum.|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||titer||95% Confidence Interval|Geometric Mean
1260968|NCT00426361|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed include 1.0 IU/mL.|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||Participants|||Count of Participants
1260969|NCT00426361|Secondary|Titers of Anti-diphtheria and Anti-tetanus Antibodies|Titers are given as Geometric Mean Titers (GMTs) and expressed as IU/mL.|One month after vaccination with Boostrix-Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||IU/mL||95% Confidence Interval|Geometric Mean
1260970|NCT00426361|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|One month post Cervarix Dose 3 (Month 7/8)]|Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1260971|NCT00426361|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month post Dose 1|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on subjects from the Cervarix and Cervarix + Boostrix Polio groups with available results for the defined antibody.|||Participants|||Count of Participants
1260972|NCT00426361|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month post Cervarix Dose 3 (Month 7/8)|Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.|||Participants|||Count of Participants
1260973|NCT00426361|Primary|Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3|Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio and with available results for the defined antigen.|||Participants|||Count of Participants
1260974|NCT00426361|Primary|Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies|Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1260975|NCT00426361|Primary|Number of Subjects Seroprotected Against Diphtheria and Tetanus|Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||Participants|||Count of Participants
1260976|NCT00426283|Secondary|To Investigate the Change in Subject Symptoms and Response to FP.||3 months|||||||
1260977|NCT00426283|Secondary|To Investigate Subject Compliance and Response to FP.||3 months|||||||
1260978|NCT00426283|Secondary|To Investigate the Relationship Between Gene Expression, Blood Levels (CBC, Serum IL-5, Eotaxin-3 and IgE) Eosinophil Phenotype, (Via Flow Cytometry and Functional Responses) and Response to FP.||3 months|||||||
1260979|NCT00426283|Secondary|To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP.||3 months|||||||
1260980|NCT00426283|Secondary|To Investigate the Safety of 1760mcg FP in the Treatment of EE Using Measurement of Serial Salivary Cortisol Levels and Adverse Reaction Data.||3 months|||||||
1260981|NCT00426283|Primary|The Percentage of Participants Who Attained Remission.|Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is </= 1 eosinophil/hpf after 3 months of therapy.|3 months||||percentage of participants||95% Confidence Interval|Number
1261006|NCT00425945|Secondary|LDL Particle Size|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||nm||Standard Deviation|Mean
1260982|NCT00426270|Secondary|Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7|The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [≤ 100 total] and/or ≤ 5 small bruises [≤ 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention).|Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.|||Percentage of participants|||Number
1260983|NCT00426270|Secondary|Duration of the Clinical Response|The duration of the clinical response was the number of days that the platelet count remained ≥ 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21.|Day 2 to the end of the study (Day 63)|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis.|||Days||Standard Deviation|Mean
1260984|NCT00426270|Secondary|Maximum Platelet Count|Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.|Day 2 to the end of the study (Day 63)|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.|||*10^9/L||Standard Deviation|Mean
1260985|NCT00426270|Secondary|Time to Achieve a Clinical Response|A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.|Day 2 to Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis.|||Days||Standard Deviation|Mean
1260986|NCT00426270|Primary|Percentage of Participants With a Clinical Response|A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.|Day 2 to Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.|||Percentage of participants|||Number
1260987|NCT00426231|Secondary|Self-reported Medication Adherence|Only individuals with 6-month follow-up data were included in this analysis|6 months||||participants|||Number
1260988|NCT00426231|Primary|Achievement of LDL-cholesterol Goals|Achieving the goal of an LDL cholesterol level of < 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.|6 months||||participants|||Number
1260989|NCT00426153|Secondary|Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores|Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).|Baseline, 12 months||||units on a scale||Standard Deviation|Mean
1260990|NCT00426153|Secondary|Percent Change in Glomerular Filtration Rate (GFR)|Percent change from baseline in renal function/GFR, measured by clearance of iothalamate with monitoring of bladder emptying using ultrasound|Baseline, 12 months|13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage.|||percent change||Standard Deviation|Mean
1260991|NCT00426153|Secondary|Percent Change in Renal Volume|Percent change from baseline in renal volume, measured in milliliters by MRI or CT scans|Baseline, 12 months|13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage.|||percent change||Standard Deviation|Mean
1260992|NCT00426153|Primary|Percent Change in Liver Volume|Percent change from baseline in liver volume, measured in milliliters by Magnetic Resonance Imaging (MRI)or Computed Tomography (CT) scans|Baseline, 12 months||||percent change||Standard Deviation|Mean
1260993|NCT00426127|Secondary|Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle||3 weeks|There was no analysis done||||||
1260994|NCT00426127|Secondary|Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle|Incidence of elevated D-Dimer was defined as >.50 as drawn every cycle. Incidence of elevated D-Dimer was tested to determine safety and efficacy of the treatment regimen on patients with advanced pancreatic cancer.|3 weeks|2 patients received at least one cycle of treatment and underwent blood draws testing D-Dimer levels|||Blood draw|||Number
1260995|NCT00426127|Primary|Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy||9 weeks|One participant underwent 3 cycles of therapy and progressed as assessed by CT.|||Participants|||Count of Participants
1260996|NCT00425945|Secondary|AST/SGOT|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||u/L||Standard Deviation|Mean
1260997|NCT00425945|Secondary|ALT/SGPT|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||u/L||Standard Deviation|Mean
1260998|NCT00425945|Secondary|Hemoglobin A1c|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.|||mg/dL||Standard Deviation|Mean
1260999|NCT00425945|Secondary|Fasting Insulin|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||mg/dL||Standard Deviation|Mean
1261000|NCT00425945|Secondary|Fasting Blood Glucose|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||mg/dL||Standard Deviation|Mean
1261014|NCT00425854|Secondary|Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)|LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.|Baseline and last assessment|TS|||Participants|||Number
1261015|NCT00425854|Secondary|Overall Survival (OS)|OS is defined as time from randomisation to death.|From randomisation to end of follow-up.|TS. As only 9 patient (31 percent) of Cohort A had died the median OS time was not estimable for Cohort A.|||days||95% Confidence Interval|Median
1261016|NCT00425854|Primary|Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. No data for Cohort B as CB was primary endpoint only for Cohort A.|||Participants|||Number
1261017|NCT00425854|Primary|Objective Response (OR)|OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. No data for Cohort A as OR was primary endpoint only for Cohort B.|||Participants with OR|||Number
1261018|NCT00425854|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS|||days||95% Confidence Interval|Median
1261019|NCT00425854|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. Median duration of OR was not calcuable as there was no OR observed.||||||
1261020|NCT00425854|Secondary|Time to OR|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. Median time to OR was not calcuable as there was no OR observed.||||||
1261021|NCT00425854|Secondary|Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. No data for Cohort A as CB was secondary endpoint only for Cohort B.|||Participants with CB|||Number
1261022|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication|||cells/microliter||Inter-Quartile Range|Median
1261023|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 6 Months||6 months|Data for the remaining 10 patients was not fully collected or analyzed for publication|||cells/microliter||Inter-Quartile Range|Median
1261024|NCT00425802|Secondary|Response to Treatment||2 years|Data for the remaining 10 patients was not fully collected or analyzed for publication|||Participants|||Count of Participants
1261025|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 3 Months||3 months|Data for the remaining 10 patients was not fully collected or analyzed for publication|||cells/microliters||Inter-Quartile Range|Median
1261026|NCT00425802|Secondary|Incidence of Chronic GVHD at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication|||percentage of participants||95% Confidence Interval|Number
1261027|NCT00425802|Secondary|Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days||100 days|Data for the remaining 10 patients was not fully collected or analyzed for publication|||percentage of patients||95% Confidence Interval|Number
1261028|NCT00425802|Secondary|Time to Platelet Engraftment||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication|||days||Full Range|Median
1261029|NCT00425802|Secondary|Time to Neutrophil Engraftment||2 years|Data for the remaining 10 patients was not fully collected or analyzed for publication|||days||Full Range|Median
1261030|NCT00425802|Primary|Overall Survival at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication|||percentage of participants||95% Confidence Interval|Number
1261031|NCT00425750|Secondary|Progression-free Survival|Median duration of survival without disease progression, calculated as on-study date to date of progression or date of death (censored) or off-study date (censored)|7.55 months (average duration, on study to off study)||||Month||95% Confidence Interval|Median
1261032|NCT00425750|Secondary|Overall Survival|Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)|7.55 months (average duration, on study to off study)||||Month||95% Confidence Interval|Median
1261033|NCT00425750|Primary|Patient Response to Treatment|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|7.55 months (average duration, on study to off study)||||participants|||Number
1261034|NCT00425698|Secondary|Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation|6 month after transplantation|||||||
1261035|NCT00425698|Primary|Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation|42 days after transplantation||||ml/min||Standard Deviation|Mean
1261096|NCT00425269|Secondary|Intake of Red Meat, Baseline||baseline||||portions/week||Inter-Quartile Range|Mean
1261036|NCT00425672|Secondary|Anti-tumor Effects of ONTAK Determined by Tumor Response and Progression|Anti-tumor effects of ONTAK will be determined by evaluating tumor response and progression per RECIST. An objective response to ONTAK will be defined as achieving a CR or PR. Analysis of the data will include determination of complete (CR) and partial response (PR) rates, as well as stable (SD) and progressive disease (PD).|21 days after cycle 6||||Participants|||Count of Participants
1261037|NCT00425672|Secondary|Presence of Endogenous Tumor-specific Immunity|Evaluate the effect of ONTAK on endogenous tumor specific immunity|21 days after cycle 6||||Participants|||Count of Participants
1261038|NCT00425672|Secondary|Presence of Circulating sIL-2R in the Peripheral Blood|Evaluate levels of circulating sIL-2R (pg/ml) in the peripheral blood assessed before and after ONTAK therapy. Changes from baseline will be tabulated.|21 days after cycle 6|4/14 patients had peripheral blood available before and after ONTAK treatment.|||pg/ml||Full Range|Median
1261039|NCT00425672|Secondary|Incidence of Interleukin-2 (IL-2) and IL-2 Receptor (IL-2R) Expression in Tumor Samples by Immunohistochemical (IHC) Analysis|The incidence of IL-2 expression and its receptor complex, IL-2R in tumor samples will be evaluated by IHC analysis. Tumor sections will be interpreted as either positive or negative.|21 days after cycle 6||||Participants|||Count of Participants
1261040|NCT00425672|Primary|Efficacy of ONTAK in Depleting T-regulatory Cells as a Decrease in Peripheral Blood Tregs Using Flow Cytometry|The efficacy of ONTAK in depleting Tregs will be defined as a decrease in peripheral blood Tregs by 25% of each individual subject’s baseline. All subjects will undergo blood draws at baseline and post ONTAK infusions at designated time points. Tregs from the peripheral blood will be quantitated using flow cytometry.|21 days after cycle 6|14 patients equals patients that had repeat blood draws taken but did not complete the treatment except for 4 patients who completed the study|||Participants|||Count of Participants
1261041|NCT00425672|Primary|Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0|Subjects are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, serum albumin, complete blood counts, symptom assessment, and physical exams performed at every cycle until 3 weeks after the final dose of ONTAK. All adverse events for all systems are graded on a scale of 1-5 using CTCAE v3.0.|7 Days after last dose of ONTAK||||Participants|||Count of Participants
1261042|NCT00425607|Primary|Proportion of Participants With Successful Rate of Weight Gain|"Activity was assessed by determining the change in rate of weight gain over two years from baseline (determined pre-therapy for each patient).~Primary outcome success was predefined as a 50% increase over pre-therapy in estimated annual rate of weight gain, or change from pre-therapy weight loss to statistically significant on-study weight gain."|Assessed at weeks 16, 32, 52, 68, 84 and 104|Results are reported for the 25 patients with classic HGPS who completed at least 2y of therapy. One additional patient with a prior history of strokes died of a stroke after 5 mo on study and is not included in the analysis. Two additional patients had nonclassic mutations and are not included in this analysis.|||proportion of participants||95% Confidence Interval|Number
1261043|NCT00425503|Primary|The Purpose of the Present Study is to Assess the Safety of PS-341 as a Pretreatment in Patients Who Are to Undergo a Radical Prostatectomy. Poor Wound Healing and Excessive Bleeding, With Historical Rates of <1% and 10% Respectively Will be Measured.|Pour wound healing is defined in the protocol as dehiscence of fascia during the first postoperative week. Excessive bleeding is defined in the protocol as greater than 2 units of blood required during the first 24 hours after surgery.|Poor wound healing (dehiscence of fascia during the first postoperative week) and bleeding 24 hours after surgery||||Events|||Number
1261044|NCT00425477|Secondary|Biological Activity as Measured by in Vivo Induction of Terminal Differentiation of Myeloid Progenitors and in Vivo Changes in Detectable Chromosomal Abnormalities||Baseline and 6, 12, 24, and 36 weeks|Due to the limited number of clinical responders, this research assay was not done.||||||
1261045|NCT00425477|Secondary|Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements|ANC count at baseline and after two cycles were measured and compared. Due to the limited number of clinical responders, the changes in transfusion requirements were not measured.|Baseline and after two cycles||||neutrophils/mm^3||Standard Error|Mean
1261046|NCT00425477|Primary|Clinical Response (Complete and Partial)|Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria.|assessed after 2 cycles, up to 2 years||||Participants|||Count of Participants
1261047|NCT00425438|Primary|Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event|CR was defined as a urinary protein value of less than (<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
1261048|NCT00425438|Secondary|Time to Treatment Failure|Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of <0.5 g/24h or greater than (>) 1 g/24h or >0.5 g/24h or >2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
1261049|NCT00425438|Secondary|Percentage of Participants Terminating Treatment||Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
1261097|NCT00425269|Secondary|Intake of Soft Drinks With Added Sugar, Baseline||baseline||||dL/week||Inter-Quartile Range|Mean
1261050|NCT00425438|Secondary|Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR)|GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
1261051|NCT00425438|Secondary|Percentage of Participants With Treatment Response Event by End of Treatment|Treatment response was defined by a reduction in the ratio of urine protein to creatinine to <3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
1261052|NCT00425438|Secondary|Complete Response|The median time, in months, to CR was defined as the time from randomization to CR event.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
1261053|NCT00425386|Secondary|Maximum Percent Change in Tumor Measurement|The maximum percent change in Tumor Measurement is the greatest percent change in longest diameter (LD) for the target lesions from the baseline LD. For patients with no change in LD, the maximum percent change is the lowest increase in LD from the baseline LD.|Baseline through end of study, up to 7 years||||percent change in size||Full Range|Mean
1261054|NCT00425386|Secondary|Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease||From the start of treatment until the criteria for response is met.||||percentage of participants|||Number
1261055|NCT00425386|Secondary|Median Time to Progression|The Kaplan-Meier method will be used to estimate the median time to progression.|For the duration of the study, up to 7 years||||months||95% Confidence Interval|Median
1261056|NCT00425386|Secondary|To Determine the Safety of Sunitinib in Combination With Erlotinib||For the duration of the study, up to 7 years||||participants|||Number
1261057|NCT00425386|Primary|Progression-free Survival at 8 Months|Defined as the proportion of patients who are progression free (CR, PR and SD) at 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum).|8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney||||percentage of participants||95% Confidence Interval|Number
1261058|NCT00425386|Primary|Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.|The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.|Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years||||milligrams|||Number
1261059|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||Percentage of patients|||Number
1261060|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||Percentage of patients|||Number
1261061|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||Percentage of patients|||Number
1261098|NCT00425269|Secondary|Intake of Vegetables, Fruit and Fruit Juice, Baseline||baseline||||gram per day||Inter-Quartile Range|Mean
1261099|NCT00425269|Secondary|Body Mass Index, Baseline||baseline||||kg/m^2||95% Confidence Interval|Mean
1261100|NCT00425269|Secondary|Waist Circumference, Baseline||baseline||||cm||95% Confidence Interval|Mean
1261101|NCT00425269|Secondary|Diastolic Blood Pressure, Baseline||baseline||||mmHg||95% Confidence Interval|Mean
1261062|NCT00425373|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
1261063|NCT00425373|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
1261064|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).|Blood chemistry - C-reactive Protein (CRP) (mg/L)|From Baseline to Month 3, 6, and 12|Safety population|||mg/L||Standard Deviation|Mean
1261065|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.||From Baseline to Month 1, 3, 6, 9, and 12|Safety population|||mmol/L||Standard Deviation|Mean
1261066|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.||From Baseline to Month 3, 6, and 12|Safety population|||mmol/L||Standard Deviation|Mean
1261067|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.|Blood chemistry - total cholesterol (mmol/L)|From Baseline to Month 1, 3, 6, 9, and 12|Safety population|||mmol/L||Standard Deviation|Mean
1261068|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Glucose.|Blood chemistry - fasting glycemia (mmol/L)|From Baseline to Month 1, 3, 6, 9, and 12|Safety population|||mmol/L||Standard Deviation|Mean
1261069|NCT00425308|Secondary|Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12|Change in proteinuria (g/24h) from baseline to M12|From Baseline to Month 3, 6, and 12|Intent to Treat Population|||g/24h||Standard Deviation|Mean
1261070|NCT00425308|Secondary|Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12|Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12|From Baseline to Month 3, 6, and 12|Intent to Treat Population|||mL/min/1.73m²||Standard Deviation|Mean
1261071|NCT00425308|Secondary|Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.||Month 12|Intent to Treat (ITT) Population|||participants|||Number
1261072|NCT00425308|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.||Month 6 and 12|Intent to Treat Population|||participants|||Number
1261073|NCT00425308|Secondary|Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12||From Baseline to Month 3, 6, and 12|Intent to Treat Population|||µmol/L||Standard Deviation|Mean
1261074|NCT00425308|Primary|Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial|Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)|From Baseline to Month 12|Intent to Treat (ITT) Population: completed patients|||(mL/min)||Standard Error|Least Squares Mean
1261075|NCT00425308|Primary|Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.|Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)|From Baseline to Month 12|Intent to Treat (ITT) Population: all patients with a baseline value|||(mL/min)||Standard Error|Least Squares Mean
1261076|NCT00425269|Secondary|Intake of Fish, Post Test||post-test, after completion of all six group sessions||||portions/week||Inter-Quartile Range|Mean
1261077|NCT00425269|Secondary|Intake of Poultry, Post-test||post-test, after completion of all six group sessions||||portions/week||Inter-Quartile Range|Mean
1261078|NCT00425269|Secondary|Intake of Red Meat, Post-test||post-test, after completion of all six group sessions||||portions/week||Inter-Quartile Range|Mean
1261079|NCT00425269|Secondary|Intake of Soft Drinks With Added Sugar, Post-test||post-test, after completion of all six group sessions||||dl/week||Inter-Quartile Range|Mean
1261080|NCT00425269|Secondary|Intake of Vegetables, Fruit and Fruit Juice, Post-test||post-test, after completion of all six group sessions||||grams per day||Inter-Quartile Range|Mean
1261081|NCT00425269|Secondary|Body Mass Index, Post-test||post-test, after completion of all six group sessions||||kg/m^2||95% Confidence Interval|Mean
1261082|NCT00425269|Secondary|Waist Circumference||post-test, after completion of all six group sessions||||cm||95% Confidence Interval|Mean
1261083|NCT00425269|Secondary|Diastolic Blood Pressure, Post-test||post-test, after completion of all six group sessions||||mmHg||95% Confidence Interval|Mean
1261084|NCT00425269|Secondary|Systolic Blood Pressure, Post-test||post-test, after completion of all six group sessions||||mmHg||95% Confidence Interval|Mean
1261085|NCT00425269|Secondary|Triglycerides, Post-test||post-test, after completion of all six group sessions||||mmol/L||95% Confidence Interval|Mean
1261086|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Post-test||post-test, after completion of all six group sessions||||mmol/L||95% Confidence Interval|Mean
1261087|NCT00425269|Secondary|Insulin, 2-h, Post-test||post-test, after completion of all six group sessions||||pmol/L||95% Confidence Interval|Mean
1261102|NCT00425269|Secondary|Systolic Blood Pressure, Baseline||baseline||||mmHg||95% Confidence Interval|Mean
1261113|NCT00425113|Primary|Changes in TB Lesion Sizes Using High Resolution Computed Tomography (HRCT).|Lesions were defined as nodules (<2 mm, 2-<4 mm, and 4-10 mm), consolidations, collapse, cavities, fibrosis, bronchial thickening, tree-in-bud opacities, and ground glass opacities. Each CT was divided into six zones (upper, middle, and lower zones of the right and left lungs) and independently scored for the above lesions by three separate radiologists blinded to treatment arm. A fourth radiologist adjudicated any scores that were widely discrepant among the initial three radiologists. The HRCT score was determined by visually estimating the extent of the above lesions in each lung zone as follows: 0=0% involvement; 1= 1-25% involvement; 2=26-50% involvement; 3=51-75% involvement; and 4=76-100% involvement. A composite score for each lesion was calculated by adding the score for each specific abnormality in the 6 lung zones and dividing by 6, with the change in composite score measured at 2 and 6 months compared to baseline. Composite sums of all 10 composite scores are reported.|6 months.||||reader score||Standard Error|Mean
1261114|NCT00425100|Secondary|Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)|Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.|Week 12|Subjects in safety set included subjects who took at least one dose of study drug. Missing responses to the Treatment Satisfaction Question at Week 12 were imputed as not satisfied for calculating the most conservative treatment satisfaction.|||participants|||Number
1261115|NCT00425100|Secondary|Sum Rating on the Urinary Sensation Scale|The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 “no feeling of urgency” to 5 “unable to hold; leak urine.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261116|NCT00425100|Secondary|"Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)"|Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically & results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.|Week 12|Population included subjects in FAS (described above) with non-missing values on OAB-S at Week 12, referred to in table below as All Subjects. Summary was presented for All Subjects and 2 subgroups, based on categorization for treatment satisfaction question used in primary endpoint assessing satisfaction.|||scores on a scale||Standard Deviation|Mean
1261117|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale|Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261118|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261119|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261120|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261121|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261122|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261178|NCT00424749|Primary|Participants With Remission of Renal Disease Activity at 3 Months|Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller)|3 months after beginning of remission induction regimen||||participants|||Number
1261123|NCT00425100|Secondary|Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)|Improvement: positive score change; No improvement: zero or negative score change|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||participants|||Number
1261124|NCT00425100|Secondary|Urgency Perception Scale (UPS)|UPS scores range from 0 (“I am usually not able to hold urine”) to 2 (“I am usually able to finish what I am doing before going to the toilet [without leaking]”).|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261125|NCT00425100|Secondary|Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)|Improvement: negative score change; No change: score change=0; Deterioration: positive score change|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||participants|||Number
1261126|NCT00425100|Secondary|Patient Perception of Bladder Condition (PPBC) Score|The PPBC score ranges from 1 “no problems at all” to 6 “many severe problems.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261127|NCT00425100|Secondary|Mean Rating on the Urinary Sensation Scale|The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 “no feeling of urgency” to 5 “unable to hold; leak urine.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1261128|NCT00425100|Secondary|Severe Urgency Episodes Per 24 Hours|Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with baseline severe urgency episodes >0 and non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||number of episodes||Standard Deviation|Mean
1261129|NCT00425100|Secondary|Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions (synonymous with the term “nighttime micturitions”) were those recorded in the bedtime section of the bladder diary.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||number of nocturnal micturitions||Standard Deviation|Mean
1261130|NCT00425100|Primary|Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment|Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.|Week 12|Subjects in the Full Analysis Set (FAS) with non-missing value at Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||participants|||Number
1261131|NCT00425100|Primary|Mean Number of Urgency Episodes Per 24 Hours|The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) >= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)).The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||number of episodes||Standard Deviation|Mean
1261132|NCT00425100|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment. Restricted to subjects with UUI at baseline >0.|||number of episodes||Standard Deviation|Mean
1261133|NCT00425100|Primary|Mean Number of Micturition Episodes Per 24 Hours|The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||number of episodes||Standard Deviation|Mean
1261146|NCT00425061|Secondary|Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3|Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).|Baseline, Day 28, 56, 84, 112|"mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. n signifies participants evaluated for this measure at the specified time point for each arm."|||log-10 IU/mL||Standard Deviation|Mean
1261134|NCT00425061|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: ALT, AST, alkaline phosphatase, total bilirubin, GGT, total LDH; renal function tests: BUN, creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||participants|||Number
1261135|NCT00425061|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin, gamma glutamyl transferase (GGT), total lactate dehydrogenase (LDH); renal function tests: blood urea nitrogen (BUN), creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
1261136|NCT00425061|Other Pre-specified|Number of Participants With Injection Site Reaction - Stage 2/3||Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.|||participants|||Number
1261137|NCT00425061|Other Pre-specified|Number of Participants With Injection Site Reaction - Stage 1||Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
1261138|NCT00425061|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3|Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 msec change from baseline and >=220 msec: QRS interval: >=120 msec: QTc interval: >450 msec for males and >470 msec for females.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.|||participants|||Number
1261139|NCT00425061|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1|Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 millisecond (msec) change from baseline and >=220 msec: QRS interval: >=120 msec: corrected QT (QTc) interval: >450 msec for males and >470 msec for females.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
1261140|NCT00425061|Other Pre-specified|Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3|Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.|||participants|||Number
1261141|NCT00425061|Other Pre-specified|Number of Participants With Clinically Important Changes in Physical Findings - Stage 1|Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
1261142|NCT00425061|Other Pre-specified|Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3|Criteria for PCI vital sign abnormalities- heart rate: >15 bpm increase from baseline and >=120 bpm, >15 bpm decrease from baseline and <=45 bpm: SBP: >=20 mmHg increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: DBP: of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.|||participants|||Number
1261143|NCT00425061|Other Pre-specified|Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1|Criteria for potentially clinically important (PCI) vital sign abnormalities- heart rate: greater than (>) 15 beats per minute (bpm) increase from baseline and greater than or equal to (>=) 120 bpm, >15 bpm decrease from baseline and less than or equal to (<=) 45 bpm: systolic blood pressure (SBP): >=20 millimeter of mercury (mmHg) increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: diastolic blood pressure (DBP): of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
1261144|NCT00425061|Secondary|Serum Interleukin-13 (IL-13) Level - Stage 2/3||Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
1261145|NCT00425061|Secondary|Serum Interleukin-13 (IL-13) Level - Stage 1||Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
1261179|NCT00424749|Secondary|Participants With Normalization of Eosinophil Count at 6 Months|Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.|6 months after beginning of remission induction regimen||||participants|||Number
1261147|NCT00425061|Secondary|Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1|Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).|Baseline, Day 28, 56, 84, 112|"mITT population (Stage 1) included all randomized participants who received at least 1 dose of test article in Stage 1. LOCF method was used to impute missing values.'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.n signifies participants evaluated for this measure at the specified time point for each arm."|||log-10 IU/mL||Standard Deviation|Mean
1261148|NCT00425061|Secondary|Blood Eosinophils Levels - Stage 2/3||Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||10^9 cells/L||Standard Deviation|Mean
1261149|NCT00425061|Secondary|Blood Eosinophils Levels - Stage 1||Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.|||10^9 cells per liter (cells/L)||Standard Deviation|Mean
1261150|NCT00425061|Secondary|Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3|FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
1261151|NCT00425061|Secondary|Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1|FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
1261152|NCT00425061|Secondary|Forced Vital Capacity (FVC) - Stage 2/3|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
1261153|NCT00425061|Secondary|Forced Vital Capacity (FVC) - Stage 1|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
1261154|NCT00425061|Secondary|Mean Number of Puffs of Rescue Medication Used - Stage 2/3|The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.|Day 8, 28, 56, 84, 89, 91, 94, 98, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
1261155|NCT00425061|Secondary|Mean Number of Puffs of Rescue Medication Used - Stage 1|The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.|Day 8, 28, 56, 84, 89, 91, 94, 98, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
1261156|NCT00425061|Secondary|Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3||Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||percentage of participant|||Number
1261157|NCT00425061|Secondary|Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1||Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.|||percentage of participants|||Number
1261158|NCT00425061|Secondary|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3|ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of =< 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1261159|NCT00425061|Secondary|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1|ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of less than or equal to (=<) 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score greater than or equal to (>=) 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1261177|NCT00424762|Secondary|Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months|proton magnetic resonance spectroscopy determination of intra-myocardial triglyceride content at baseline and after 6 months, with triglyceride quantified analyzing fat and water signals assuming monoexponential signal decay and expressed as a percentage of fat-to-water (%)|6 months|analysis limited to those with interpretable imaging data at baseline and end of study|||percentage of fat-to-water; %||Standard Deviation|Mean
1261160|NCT00425061|Secondary|Change From Baseline in Airway Hyper-reactivity at Day 28 and 112|Airway hyper-reactivity was assessed using provocative concentration 20 (PC20). PC20 was the concentration of methacholine at which participants had 20 percent (%) decrease in FEV1. Results for PC20 were summarized together for all participants who received any dose of IMA-638 and for all participants who received placebo during any stage of the study as per investigator's discretion.|Baseline, Day 28, 112|mITT population included all randomized participants who received at least 1 dose administration of the test article. LOCF method was used to impute missing values. 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||milligram per milliliter (mg/mL)||Standard Deviation|Geometric Mean
1261161|NCT00425061|Secondary|Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||liter||Standard Deviation|Mean
1261162|NCT00425061|Secondary|Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.|||liter||Standard Deviation|Mean
1261163|NCT00425061|Primary|Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.|Baseline, Day 112|"mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. n signifies those participants who were evaluated for this measure at the specified time point for each arm."|||L/min||Standard Deviation|Mean
1261164|NCT00425061|Primary|Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.|Baseline, Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. Last observation carried forward (LOCF) method was used to impute missing values.|||liter per minute (L/min)||Standard Deviation|Mean
1261165|NCT00424827|Secondary|Toxicity Associated With This Regimen.||1-Year||||participants|||Number
1261166|NCT00424827|Secondary|Overall Survival||Up to 2 years||||months||95% Confidence Interval|Median
1261167|NCT00424827|Secondary|Resection Rate||1-Year|4 subjects underwent resection after treatment|||participants|||Number
1261168|NCT00424827|Secondary|Biomarker Response to Chemoradiation Therapy|20% decrease in biomarker (CA19-9) from baseline|1-year|Biomarker response (CA19-9) as defined by at least a 20% decrease from baseline|||participants|||Number
1261169|NCT00424827|Primary|Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1-year|Must have histologic confirmation of pancreatic adenocarcinoma with measurable disease per RECIST criteria, with locoregional disease not amenable to surgery were enrolled: based on(1) size of the tumor, 5cm; (2) lymph nodes; (3) vascular involvement or impingement on major vessels; and (4) invasion into the adjacent structures.|||months||95% Confidence Interval|Median
1261170|NCT00424775|Secondary|Maximum Concentration (Cmax) at Day 5|Maximum Concentration (Cmax) = the maximum plasma concentration of the drug|Day 5|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.|||µM||Full Range|Mean
1261171|NCT00424775|Secondary|Maximum Concentration (Cmax) at Day 4|Maximum Concentration (Cmax) = the maximum plasma concentration of the drug|Day 4|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.|||µM||Full Range|Mean
1261172|NCT00424775|Secondary|Area Under the Curve (AUC(0-24 hr)) at Day 5|Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.|Day 5|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.|||µM hr||Full Range|Mean
1261173|NCT00424775|Secondary|Area Under the Curve (AUC(0-24 hr)) at Day 4|Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.|Day 4|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.|||µM hr||Full Range|Mean
1261174|NCT00424775|Primary|Number of Participants With a Dose Limited Toxicity at First Cycle|Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.|25 Days (first cycle)|All participants who received vorinostat 300 mg once daily.|||Participants|||Number
1261175|NCT00424762|Secondary|Percentage of Patients Developing New or Worsening Peripheral Edema|clinical evaluation of peripheral edema by physical exam at each study visit by a cardiologist using standard clinical severity scale 0-4, with new/worsening edema defined as any edema in patients with none at baseline, OR increase in severity by 2 or more points in patients with edema at baseline|6 months||||percentage of patients|||Number
1261176|NCT00424762|Primary|Peak Oxygen Uptake (VO2)|measurement of peak oxygen uptake (VO2peak) during treadmill exercise, in units of milliliters of oxygen per kilogram of fat-free mass per minute|6 months|completed baseline and end-of-study cardiopulmonary exercise test|||ml O2 uptake/kg fat-free mass/minute||Standard Deviation|Mean
1261180|NCT00424645|Primary|Patient Response Rate (Percentage)|Response rate defined as proportion of patients that clear methotrexate (MTX) at 15 min and 24-hour post infusion of study drug, Glucarpidase (Voraxaze) to total patient number. Serum MTX levels (standard methods and mass spectrometry) at 15 minutes, 24 hours, or daily until MTX clearance defined as serum MTX level <0.1 µmol/L.|Study period 2 years|Analysis was to be per protocol, low accrual and early termination led too few responses for evaluation.||||||
1261181|NCT00424632|Secondary|Aurora Gene Somatic Mutations/Amplification and Pathway Genes in Tumor Tissue|Percentage of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)|Data was not summarized as the development of the compound was discontinued.|||percentage of cells|||Number
1261182|NCT00424632|Secondary|Germ Line Polymorphism of Candidate Genes Targeted by PF-03814735|Percentage of germ line polymorphism cell expression in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of LD of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)|Data was not summarized as the development of the compound was discontinued.|||percentage of cells|||Number
1261183|NCT00424632|Secondary|Duration of Response|Duration of responses based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.|||months|||Number
1261184|NCT00424632|Secondary|Time to Progression|Time to Progression defined as the time from the date of enrollment to the date progressive disease first reported. If tumor progression data included more than 1 date, the first date was to be used. TTP = (first date of tumor progression – date of enrollment + 1). Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.|||months|||Number
1261185|NCT00424632|Secondary|Number of Participants With Objective Tumor Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.|||participants|||Number
1261186|NCT00424632|Secondary|Target Modulation by Phosphohistone H3 (pH3) Expression in Tumor Tissue (IHC)|pH3 expression is a method to enable the quantification of the proliferative potential of tumor cells. Post-dose tumor tissue sampling occurred after FDG-PET. Biopsies were not to be taken from lesions which were used for PET analysis and were to be taken between 1 and 6 hours after study drug administration. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10|Data was not summarized as the development of the compound was discontinued.|||percentage of cells||Standard Deviation|Mean
1261187|NCT00424632|Secondary|Summary of Tumor Metabolism Assessed by Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)|FTD-PET measured as standardized uptake volume (SUV) values corrected for lean body mass. Change from baseline categorized according to European Organization for Research and Treatment for Cancer (EORTC) criteria: Partial Metabolic Response (PMR): SUV value during treatment <75 percent (%) of baseline value; Progressive Metabolic Disease (PMD): SUV value during treatment >125% of baseline value; Stable Metabolic Disease (SMD): change in SUV value between PMR and PMD. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).|Baseline (Schedule A or Schedule B Day -7) and Schedule A Cycle 1/Day 3 or Day 4, Schedule B Cycle 1/Day 8 or 9|Data was not summarized as the development of the compound was discontinued.|||percent change||Standard Deviation|Mean
1261188|NCT00424632|Secondary|Urine Pharmacokinetics|Urine PK for quantification of unchanged PF-03814375 and any identified metabolites. 24-hour urine collection at 8-hour intervals after the morning dose (Schedule [Sch] A Day 4, Sch B Day 9; last sample collected just prior to the morning dose on Sch A Day 5 or Sch B Day 10 in the expanded maximum tolerated dose (MTD) cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups). The lower limit of quantification (LLOQ) was 1 nanogram per milliliter (ng/mL). Clinical specimens with concentrations below the LLOQ were to be reported as below the limited of quantification (BLQ) 1 ng/mL.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Data was not summarized as the development of the compound was discontinued.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1261189|NCT00424632|Secondary|Terminal Half-life (t 1/2)|Terminal half-life (serum decay half-life) is the time measured for the serum concentration to decrease by one half.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Half-life (t ½) was not reported for multiple-dose data since the 24-hour sampling period was not long enough to adequately characterize t ½.|||hours||Standard Deviation|Mean
1261190|NCT00424632|Secondary|Observed Serum Accumulation Ratio (Rac)|Rac was the ratio of Schedule B Cycle 1/Day 9 to Day -5 (Day 9 AUCτ to Day -5 AUCτ).|Schedule B Day-5: pre-dose, 0.5, 1, 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dose, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set. N=number of participants in the indicated population contributing to the mean.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1261191|NCT00424632|Secondary|Minimum Observed Serum Trough Concentration (Cmin)|Cmin defined as the lowest serum concentration observed during the dosing interval.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1261192|NCT00424632|Secondary|Area Under the Serum Concentration Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 24 Hours (AUCτ).||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1261193|NCT00424632|Secondary|Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Data was not summarized as the development of the compound was discontinued.|||mcg*hr/mL||Full Range|Median
1261194|NCT00424632|Secondary|Time for Maximum Observed Serum Concentration (Tmax)||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set|||hours||Full Range|Median
1261195|NCT00424632|Secondary|Maximum Observed Serum Concentration (Cmax)||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Pharmacokinetic (PK) parameter analysis set: Enrolled participants who received at least 1 dose of study treatment who had at least 1 of the PK parameters of interest estimated in at least 1 treatment period.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1261196|NCT00424632|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3|DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; neutropenic infection (ANC <1000/mm^3); Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal antiemetic, anti-diarrheal support; ≥20% decrease in left ventricular ejection fraction compared to baseline; other non-hematological toxicity; any Gr ≥3 adverse event; or failure to recover.|Day 1 up to Day 21 of first cycle|Safety population: Same as the As-treated population, defined as all patients enrolled in the study that received at least 1 dose of the study medication.|||participants|||Number
1261197|NCT00424619|Secondary|Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months|The 2MWT was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended rehabilitation, it was abstracted from their charts. The 2MWT test was given in a carpeted corridor and the subject was instructed to wear regular footwear and to use their customary walking aid. The distance the participant could comfortably walk in two-minutes (without physical assistance) was measured in metres.|3 months|The number of participants who completed the 2WT is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional 2WT test at this time point.|||meters||Full Range|Mean
1261198|NCT00424619|Primary|Creatinine|Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.|Baseline||||µmol/L||Standard Deviation|Mean
1261199|NCT00424619|Primary|Hemoglobin|Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.|Baseline||||g/L||Standard Deviation|Mean
1261200|NCT00424619|Primary|Alkaline Phosphatase|Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.|Baseline||||U/L||Standard Deviation|Mean
1261201|NCT00424619|Primary|Phosphate|Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.|Baseline||||mmol/L||Standard Deviation|Mean
1261202|NCT00424619|Primary|Calcium|Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.|Baseline, 4 weeks||||mmol/L||Standard Deviation|Mean
1261203|NCT00424619|Primary|Parathyroid Hormone (PTH)|Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.|Baseline||||pmol/L||Standard Deviation|Mean
1261204|NCT00424619|Primary|25-hydroxyvitamin D3 (25-OHD)|Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).|Baseline, 4 weeks and 3 months|Baseline data (n=59) was missing for two participants, and four outliers with 25-OHD taken at 6, 10 or 12 days were not included. 4-week data (n=50) was missing for 13 participants, and two outliers with 25-OHD taken at <13 days were not included. 3-month data (n=47) was missing for 18 participants.|||nmol/L||95% Confidence Interval|Mean
1261205|NCT00424619|Secondary|Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months|The Timed Up and Go (TUG) was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended the rehabilitation unit this is routinely collected and was abstracted from chart. The TUG was conducted using a standard armchair and a line marked 3-metres from the chair. Participants were given the following instructions (no physical assistance was given): “Rise from the chair, walk to the line on the floor, turn, return to the chair and sit down again”. Scores are measured as time in seconds to complete the task.|3 months|The number of participants who completed the TUG test is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional TUG test at this time point.|||seconds||Full Range|Mean
1267558|NCT00379912|Secondary|BclXL Expression||Six months|Analysis of BclXL expression was undertaken irrespective of arm assignment and categorized between responsers and non-responders|||percentage L27 mRNA||Standard Error|Mean
1261206|NCT00424593|Other Pre-specified|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase|Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.|Week 13 through Week 54|Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.|||participant|||Number
1261207|NCT00424593|Other Pre-specified|Serious Adverse Events During the Dose-Blind Extension Phase|Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.|Week 13 though Week 54|Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.|||participants|||Number
1261208|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||kilograms (kg)||Standard Deviation|Mean
1261209|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||mm Hg||Standard Deviation|Mean
1261210|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||beats per minute (bpm)||Standard Deviation|Mean
1261211|NCT00424593|Secondary|Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid||Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits only. Last observation carried forward.|||micromole per Liter (μmol/L)||Standard Deviation|Mean
1261212|NCT00424593|Secondary|Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate||Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value, based on the first values at scheduled visits only. Last observation carried forward.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
1261213|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261214|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
1261215|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.~Absenteeism=(Q2/(Q2+Q4))*100~Presenteeism=(Q5/10)*100~Work productivity loss=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100~Activity Impairment=(Q6/10)*100"|Baseline, Week 13, Week 54|"Number of participants currently being paid to work who had a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
1261216|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261229|NCT00424554|Secondary|Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE)|An AE was defined as any event which was adverse, including what were commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product. Additionally, any event which was associated with, or observed in conjunction with product overdose whether accidental or intentional, or product abuse and/or withdrawal was also considered an AE.|12 months||||participants|||Number
1261217|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261218|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
1261219|NCT00424593|Secondary|Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria|Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.|Week 13|Number of randomized participants with non-missing response values.|||participants|||Number
1261220|NCT00424593|Secondary|Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria|Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.|Week 13|Number of randomized participants with non-missing response values.|||participants|||Number
1261221|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
1261222|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
1261223|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale|24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.|Baseline, Week 13|Number of randomized participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261224|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
1261225|NCT00424593|Secondary|Patient's Global Impression of Improvement (PGI-I)|A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 13|Number of participants with at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261226|NCT00424593|Primary|Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of participants with baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1261227|NCT00424554|Secondary|MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels|No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.|14 days|||||||
1261228|NCT00424554|Secondary|Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor|No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.|14 days|||||||
1261230|NCT00424554|Secondary|Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities|"Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).~Grade 4 was defined as life-threatening per CTCAE."|12 months||||participants|||Number
1261232|NCT00424528|Secondary|Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score|A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.|2 weeks|Total number of subjects in each arm: 76, 80, 78|||Percentage of participants|||Number
1261233|NCT00424528|Secondary|Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score|A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.|2 weeks|Total number of subjects in each arm: 76, 80, 78|||Participants|||Number
1261234|NCT00424528|Secondary|Transition Dyspnea Index (TDI) Focal Score|TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement.|2 weeks|Total number of subjects in each arm: 76, 80, 78|||Units on a scale||Standard Deviation|Mean
1261235|NCT00424528|Secondary|Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day|Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period.|2 weeks||||Actuations per day||95% Confidence Interval|Mean
1261236|NCT00424528|Secondary|Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week|Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol.|2 weeks||||Days per week||95% Confidence Interval|Mean
1261237|NCT00424528|Secondary|Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint||2 Weeks||||Liters||Standard Deviation|Mean
1261238|NCT00424528|Secondary|Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing|Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC.|2 weeks|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
1261239|NCT00424528|Secondary|Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks|Analyzed from end of dosing to 12 hours.|2 weeks|Total number of subjects in each arm: 76, 80, 78.|||Hours||Full Range|Median
1261240|NCT00424528|Secondary|Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks|Analyzed from end of dosing to 12 hours.|2 weeks|Total number of subjects in each arm: 76, 80, 78.|||Hours||Full Range|Median
1261241|NCT00424528|Secondary|Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline|12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment.|2 weeks||||Liters||95% Confidence Interval|Mean
1261242|NCT00424528|Secondary|Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication|Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted.|2 weeks||||Percent of predicted FEV1||Standard Deviation|Mean
1261243|NCT00424528|Secondary|Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication|Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1.|2 weeks||||Liters||Standard Deviation|Mean
1261244|NCT00424528|Secondary|Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)|Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1.|Following 2 weeks of dosing|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
1261245|NCT00424528|Secondary|Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)||Following 2 weeks of dosing|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
1261246|NCT00424528|Secondary|Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)||0-12 hours following two weeks of dosing|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
1261247|NCT00424528|Primary|Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)||24 hours following two weeks of dosing.|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
1261248|NCT00424515|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1).|The analysis dataset is comprised of treated patients.|||months||95% Confidence Interval|Median
1261249|NCT00424515|Secondary|Time to Progression|Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).|The analysis dataset is comprised of treated patients.|||months||95% Confidence Interval|Median
1261282|NCT00424398|Primary|Conjunctival Redness|Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1286680|NCT00168831|Secondary|Change From Baseline in Lymphocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1261250|NCT00424515|Primary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).|The analysis dataset is comprised of treated patients.|||participants|||Number
1261251|NCT00424502|Secondary|C-Reactive Protein (CRP)|CRP was measured in milligrams per liter (mg/L).|Day 0 and Week 24|All participants who received at least 1 dose of study drug.|||mg/L||Standard Deviation|Mean
1261252|NCT00424502|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR was measured in mm/hr.|Day 0 and Week 24|All participants who received at least 1 dose of study drug.|||mm/hr||Standard Deviation|Mean
1261253|NCT00424502|Secondary|Vascular Endothelial Growth Factor (VEGF)|VEGF was measured as picograms per milliliter (pg/mL).|Day 0 and Week 24|All participants who received at least 1 dose of study drug.|||pg/mL||Standard Deviation|Mean
1261254|NCT00424502|Secondary|Anti-cyclic Citrullinated Peptide (Anti-CCP)|Anti-CCP measured as absorbance units per milliliter (AU/mL).|Day 0 and Week 24|All participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.|||AU/mL||Standard Deviation|Mean
1261255|NCT00424502|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|Day 0 and Week 24|All enrolled participants. n (number) = number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1261256|NCT00424502|Primary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.|Day 0 and Week 24|All enrolled participants who received at least one dose of study treatment.|||units on a scale||Standard Deviation|Mean
1261257|NCT00424489|Primary|Survival|Survival|Up to 5 years|Survival both treatment related and non-treatment related|||Participants|||Count of Participants
1261258|NCT00424476|Other Pre-specified|Adverse Events (AE) Overview|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 56 Weeks||||Percentage of participants|||Number
1261259|NCT00424476|Secondary|Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52||Baseline, Weeks 40 through 52|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day|||Percentage of participants|||Number
1261260|NCT00424476|Secondary|Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.|The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Scores on a scale||Standard Error|Mean
1261261|NCT00424476|Secondary|Mean Change in Physician's Global Assessment (PGA) at Wk 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Scores on a 3-point scale||Standard Error|Mean
1261262|NCT00424476|Secondary|Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.||Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Percentage of participants|||Number
1261263|NCT00424476|Primary|SLE Responder Index (SRI) Response Rate at Week 52|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 52 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.|||Percentage of participants|||Number
1261264|NCT00424463|Secondary|Percentage of Participants With Abnormal Changes in Sensory Examinations||36 weeks (from seventh cycle to fifteenth cycle)||||percentage of participant|||Number
1261268|NCT00424463|Secondary|Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks|To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.|baseline (seventh cycle) and at 24 week (twelfth cycle)|"1 patient with diseases other than ALS and 4 patients with missing data were excluded from the FAS in the MCI-186 - Placebo of MCI-186group.~6 patients with missing data were excluded from the FAS in the MCI-186 - MCI-186 group.~19 patients with missing data were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group."|||percentage of FVC||Standard Deviation|Mean
1261269|NCT00424463|Secondary|Number of Participants With Death or a Specified State of Disease Progression|Any of “death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding” was defined as an event.|24 weeks (from seventh cycle to twelfth cycle)|"1 patient with diseases other than ALS was excluded from the FAS in the MCI-186 - Placebo of MCI-186 group."|||Participants|||Count of Participants
1261270|NCT00424463|Primary|Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks|0=worst; 48=best To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.|baseline (seventh cycle) and at 24 week (twelfth cycle)|"1 patient with diseases other than ALS and 4 patients with missing data were excluded from the FAS in the MCI-186 - Placebo of MCI-186group.~5 patients with missing data were excluded from the FAS in the MCI-186 - MCI-186 group.~14 patients with missing data were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group."|||units on a scale||Standard Deviation|Mean
1261271|NCT00424398|Secondary|Total Nasal Symptom|Total Nasal Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261272|NCT00424398|Secondary|Eyelid Swelling|Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261273|NCT00424398|Secondary|Ocular Mucus Discharge|Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Percent of Eyes with OMD Present|||Number
1261274|NCT00424398|Secondary|Tearing|Percent of Eyes with Tearing. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Percent of Eyes with Tearing Present|||Number
1261275|NCT00424398|Secondary|Nasal Congestion|Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261276|NCT00424398|Secondary|Ear or Palate Pruritus (Itchy Ear or Palate)|Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261277|NCT00424398|Secondary|Nasal Pruritus (Itchy Nose)|Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261278|NCT00424398|Secondary|Rhinorrhea (Runny Nose)|Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261279|NCT00424398|Secondary|Chemosis|Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely Severe-Overall ballooning of conjunctiva|15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261280|NCT00424398|Secondary|Episcleral Redness|Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261281|NCT00424398|Secondary|Ciliary Redness|Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261283|NCT00424398|Primary|Ocular Itching|Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
1261284|NCT00424385|Secondary|Time to Disease Progression (TTP)|Medium TTP is 2 months (range 1-5). 10 patients were evaluable for disease progression for these patients occurred between 1-5 months after starting the study. The TTP was calculated per protocol. For radiographic assessment Response Evaluation Criteria in Solid Tumors (RECIST) was used. Complete response = disappearance of all lesions. Partial response (PR)=30% or greater decrease in sum of longest diameter of measureable lesions SD. Lesions have no sufficient decrease for progressive disease and no sufficient increase to meet Progressive Disease (PD). PD more than 20% increase in sum of longest diameter of measurable lesions or 2 or more new bone mets. prostate-specific antigen (PSA) assessment for patients with measurable disease, PSA progression in the absence of measurable disease progression will not be considered progressive disease.|up to 5 cycles, an average of 20 weeks, from the day of first treatment until the date of the last dose of study drug||||months||Full Range|Median
1261285|NCT00424385|Secondary|Overall Clinical Benefit|Overall Clinical Benefit was measured as the sum of complete response (CR), partial response (PR), and stable disease (SD).|up to 20 weeks|There were 17 patients enrolled. 10 were evaluable for assessment of overall clinical benefit. 7 were not evaluable due to having received <1 cycle of drug.|||percentage of evaluable participants|||Number
1261286|NCT00424385|Primary|Number of Patients Experiencing Dose Limiting Toxicities (DLT's)|Eligible patients were enrolled in one of 4 cohorts, where each cohort allowed 3 evaluable patients to be on study, patients withdrawn from treatment for reasons other than toxicity were not considered evaluable. If one of the three evaluable patients experienced a dose limiting toxicity (DLT) the cohort was expanded to 6 evaluable patients. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. If 2 out of six evaluable patients experience a dose limiting toxicity this would show that the Maximum Tolerated Dose (MTD) was the dose from the prior cohort.|up to 20 weeks|Cohort 0: 6 evaluable patients were enrolled. Patients who withdrew for reasons other than toxicity were not considered evaluable for MTD. 1 out of 6 patients had a DLT, therefore Cohort 1 was started. Cohort 1: 2 DLTs were demonstrated from 5 evaluable patients. By definition the Maximum tolerated dose was the dosing schedule used in cohort 0.|||participants|||Number
1261287|NCT00424372|Primary|Summary of Adverse Events|Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.|52 weeks|Safety population: all subjects who took at least 1 dose of study medication.|||subjects|||Number
1261288|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale|Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||mm||Standard Deviation|Mean
1261289|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity|Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||score on scale||Standard Deviation|Mean
1261290|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score|Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||score on scale||Standard Deviation|Mean
1261291|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score|Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||score on scale||Standard Deviation|Mean
1261292|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score|Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||score on scale||Standard Deviation|Mean
1261293|NCT00424346|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate During the Extension Study|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.|Baseline and Weeks 24, 36, 48, 60, 72 and 88.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||mm/hr||Standard Deviation|Mean
1261294|NCT00424346|Secondary|Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels During the Extension Study|HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||mg/L||Standard Deviation|Mean
1261295|NCT00424346|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score During the Extension Study|The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
1261296|NCT00424346|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Extension Study|The physician's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient's global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
1261297|NCT00424346|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity During the Extension Study|"The patient's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
1261298|NCT00424346|Secondary|Change From Baseline in Patient's Pain Intensity During the Extension Study|The patient's assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
1261299|NCT00424346|Secondary|Change From Baseline in Tender 28-joint Count During the Extension Study|The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||tender joints||Standard Deviation|Mean
1261300|NCT00424346|Secondary|Change From Baseline in Swollen 28-joint Count During the Extension Study|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||swollen joints||Standard Deviation|Mean
1261301|NCT00424346|Secondary|Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at the End of the Extension Study|"To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, patients were categorized as follows:~Did not attain an ACR20 response;~Attained a 20% but not a 50% response;~Attained a 50% but not a 70% response;~Attained a 70% or greater response.~A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP])."|Baseline and End of Study (up to 124 weeks)|Extension Study ITT population.|||participants|||Number
1261302|NCT00424346|Primary|Change From Baseline in Disease Activity Score (DAS) 28 During the Extension Phase|"The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) in mg/L;~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6"|Baseline and Weeks 24, 72 and 112|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
1261325|NCT00424294|Other Pre-specified|Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91||Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, “n” signifies those participants who were evaluable at specified time point for each arm, respectively.|||beats per minute||Standard Deviation|Mean
1261563|NCT00423267|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A|Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.|12 months||||Participants|||Number
1261303|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 70 Criteria Responders During the Extension Phase|"Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR70 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR70 evaluation data available.|||percentage of participants|||Number
1261304|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders During the Extension Phase|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR50 evaluation data available.|||percentage of participants|||Number
1261305|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders During the Extension Phase|"Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR20 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR20 evaluation data available.|||percentage of participants|||Number
1261306|NCT00424346|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F)|"The fatigue subscale of the FACIT is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants respond to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline FACIT-F value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||scores on a scale||Standard Error|Least Squares Mean
1261307|NCT00424346|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36)|The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||scores on a scale||Standard Deviation|Mean
1261308|NCT00424346|Secondary|Change From Baseline in Rheumatoid Factor Concentration|Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) that is an indicator of inflammation and rheumatoid arthritis.|Baseline and Weeks 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||kIU/L||Standard Deviation|Mean
1261309|NCT00424346|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||mm/hr||Standard Deviation|Mean
1261326|NCT00424294|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.|Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, “n” signifies those participants who were evaluable at specified time point for each arm, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1261310|NCT00424346|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) in mg/L;~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline DAS28 value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||scores on a scale||Standard Error|Least Squares Mean
1261311|NCT00424346|Secondary|Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels|"HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||mg/L||Standard Error|Least Squares Mean
1261312|NCT00424346|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score|"The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from ‘without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||scores on a scale||Standard Error|Least Squares Mean
1261313|NCT00424346|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity|"The physician’s global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient’s global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by|||scores on a scale||Standard Error|Least Squares Mean
1261314|NCT00424346|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity|"The patient’s global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing”. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by|||scores on a scale||Standard Error|Least Squares Mean
1261315|NCT00424346|Secondary|Change From Baseline in Patient’s Pain Intensity|"The patient’s assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by|||scores on a scale||Standard Error|Least Squares Mean
1261316|NCT00424346|Secondary|Change From Baseline in Tender 28-joint Count|"The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, the number of patients included in the analysis at each time point is indicated by N. Last observation carried forward was utilized."|||tender joints||Standard Error|Least Squares Mean
1261317|NCT00424346|Secondary|Change From Baseline in Swollen 28-joint Count|"The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, the number of patients included in the analysis at each time point is indicated by N. Last observation carried forward was utilized."|||swollen joints||Standard Error|Least Squares Mean
1262669|NCT00414453|Secondary|Patient Global Impression of Change Scale|Subject completes patient global impression questionaire of change scale|Occurs Visit 3, 4, 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
1261318|NCT00424346|Secondary|Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at Week 12|"To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, participants were categorized as follows:~Did not attain an ACR20 response;~Attained a 20% but not a 50% response;~Attained a 50% but not a 70% response;~Attained a 70% or greater response.~A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient’s pain assessment (100 mm visual analog scale [VAS]);~Patient’s global assessment of disease activity (VAS 100 mm);~Physician’s global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP])."|Baseline and Week 12|The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR evaluation. Last observation carried forward was applied for all the component variables.|||participants|||Number
1261319|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 70 Criteria Responders|"Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered ACR70 non-responders if they failed the ACR70 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders."|Baseline and Weeks 2, 4, 8 and 12|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR70 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."|||percentage of participants|||Number
1261320|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders|"Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered ACR20 non-responders if they failed the ACR20 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders."|Baseline and Weeks 2, 4, 8 and 12|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR20 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."|||percentage of participants|||Number
1261321|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Weeks 2, 4 and 8|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 2, 4 and 8|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."|||percentage of participants|||Number
1261322|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Week 12|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient’s pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient’s global assessment of disease activity (VAS 100 mm);~Physician’s global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Details on each of these components are provided in Outcome Measures 10-16. Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Week 12|The intent-to-treat (ITT) population consisted of all patients as randomized that received at least one dose of study drug and had at least one post-baseline efficacy assessment. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables.|||percentage of participants|||Number
1261323|NCT00424294|Other Pre-specified|Number of Participants With Categorical Vital Signs Data|Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.|Baseline, Week 12|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Detailed categorical data was not estimated since summarized continuous data of the vital signs were considered sufficient for the analysis as per investigator’s discretion.|||participants|||Number
1261324|NCT00424294|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett’s Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia’s Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.|Baseline up to Week 12|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||participants|||Number
1286681|NCT00168831|Secondary|Change From Baseline in Basophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1261327|NCT00424294|Secondary|Number of Participants With Clinical Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).|Baseline up to Week 13|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||participants|||Number
1261328|NCT00424294|Other Pre-specified|Number of Adverse Events by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild – AEs does not interfere with participant’s usual function b) moderate – AEs interferes to some extent with participant’s usual function c) severe – AEs interferes significantly with participant’s usual function.|Baseline up to 28 days after last dose|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||adverse events|||Number
1261329|NCT00424294|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||participants|||Number
1261330|NCT00424294|Secondary|Time to Withdrawal Due to Lack of Efficacy||Baseline up to Week 12|Median time and corresponding confidence interval (CI) were not estimable because only less than half of the participants withdrew from study due to lack of efficacy and hence, were insufficient for the analysis.||||||
1261331|NCT00424294|Secondary|Number of Participants Who Withdrew From Study Due to Lack of Efficacy||Baseline up to Week 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||participants|||Number
1261332|NCT00424294|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12|Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||hour||Standard Deviation|Mean
1261333|NCT00424294|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 * ([0.56 * square root of TJC] + [0.28 * square root of SJC] + [0.36 * natural logarithm of {CRP+1}]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||units on a scale||Standard Deviation|Mean
1261334|NCT00424294|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1261335|NCT00424294|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||units on a scale||Standard Deviation|Mean
1261719|NCT00422383|Secondary|Peripheral CD19+CD27 Negative (-) B Cell Count in Cells/µL|Surface expression of CD19 in the absence of CD27 expression was assessed by FACS analysis as a marker of naive B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261336|NCT00424294|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12|Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||units on a scale||Standard Deviation|Mean
1261337|NCT00424294|Secondary|Change From Baseline in Patient’s Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12|Patient’s global assessment of arthritic condition assessed all the ways participants’ illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||units on a scale||Standard Deviation|Mean
1261338|NCT00424294|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12|Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||mm||Standard Deviation|Mean
1261339|NCT00424294|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12|Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||swollen joints||Standard Deviation|Mean
1261340|NCT00424294|Secondary|Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12|Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||tender/painful joints||Standard Deviation|Mean
1261341|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.|||percentage of participants|||Number
1261342|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.|||percentage of participants|||Number
1261343|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.|||percentage of participants|||Number
1261344|NCT00424294|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using last observation carried forward (LOCF) method.|||percentage of participants|||Number
1261345|NCT00424268|Secondary|Shortness of Breath Questionnaire (SOBQ) Total Score|"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity."|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
1261346|NCT00424268|Secondary|Transition Dyspnea Index (TDI) Focal Score|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
1261347|NCT00424268|Secondary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|24 weeks treatment period|ITT analysis|||exacerbations per patient per year||95% Confidence Interval|Mean
1261348|NCT00424268|Secondary|Post-bronchodilator FEV1|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
1261349|NCT00424268|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
1261350|NCT00424255|Secondary|Number of Participants With the Indicated Worst-case On-therapy Left Ventricular Ejection Fraction (LVEF) Change From Baseline|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart with each contraction. LVEF was assessed using echocardiogram (ECHO: a test of the action of the heart using ultrasound waves to produce a visual display, for the diagnosis or monitoring of heart disease ) and multigated acqusition scans (MUGA scan: a noninvasive diagnostic test used to evaluate the pumping function of the ventricles). Data from the ECHO and MUGA scans were combined, and the absolute change from Baseline (Abs) data are presented according to the following categories: No change or any increase, 0-<10% decrease, 10-19% decrease, >=20% decrease, >=10% decrease and >=the Lower Limit of Normal (LLN), >=10% decrease and below LLN, >=20% decrease and >=LLN, or >=20% decrease and below LLN. The relative percent change from Baseline (Rel) data are presented according to the following categories: >=20% decrease and >=LLN and >=20% decrease and below LLN.|From the end of the CRT until the last follow-up visit (average of 141 study weeks)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1261351|NCT00424255|Secondary|Number of Participants With the Indicated Biomarker Expression Status|Biomarkers (which influence clinical response) assessed from tumor tissues included P16, Human Papilloma virus (HPV), and Epidermal Growth Factor Receptor (EGFR)/Epidermal Growth Factor Receptor 1 (ErbB1). Biomarker expression is presented as positive, negative, or unknown. Participants in the ErbB1-positive category include those with results of positive or strongly positive.|Baseline (BL; within 8 weeks prior to randomization [Day 1]) (up to Study Week 1)|ITT Population|||Participants|||Number
1261352|NCT00424255|Secondary|Change From Baseline in Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale|Change from Baseline in quality of life status was assessed using the EQ-5D scale, a 5-item health status measure and a visual analog rating scale. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The EQ-5D is a generic measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. The EQ-5D covers health status in 5 domains (3 questions each): mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each item is scored as follows: 1, no problems; 2, some moderate problems; 3, extreme problems. The possible EQ-5D index utility values range from 0.594 to 1, and the thermometer score ranges from 0 to 100. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.|From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)|Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1261353|NCT00424255|Secondary|Change From Baseline in Quality of Life Status as Assessed by the Functional Assessement of Cancer Therapy-Head and Neck (FACT-H&N) Questionnaire|Change from Baseline in quality of life status was assessed using the FACT-H&N questionnaire, which is designed to measure multidimensional quality of life in participants with head and neck cancer. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The FACT-H&N questionnaire contains 39 items (27 general questions and 12 head and neck cancer-specific items) covering 4 dimensions and 1 subscale: physical well-being, social/family well-being, emotional well-being, functional well-being, and a head and neck cancer subscale. Possible subscale scores range from 0 to 36. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.|From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)|Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1268506|NCT00371865|Secondary|SF-12|This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
1261354|NCT00424255|Secondary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value|The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used by doctors and researchers to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|From Baseline (BL; within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population|||Participants|||Number
1261355|NCT00424255|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12-lead ECG was recorded at Baseline, at the end of the CRT, at Maintenance Week 56, at withdrawal from IP, and at anytime post-baseline. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. The study investigator determined if an abnormal ECG finding was CS or NCS.|Baseline (BL; within 8 weeks prior to randomization [Day 1]), End of CRT, Maintenance Week 56, Withdrawal from IP, and at any time Post-Baseline (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1261356|NCT00424255|Secondary|Change From Baseline in Body Weight at the Indicated Time Points|Body weight was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Kilograms||Standard Deviation|Mean
1261357|NCT00424255|Secondary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Degrees Centigrade||Standard Deviation|Mean
1261358|NCT00424255|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate (HR) was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Beats per minute||Standard Deviation|Mean
1261359|NCT00424255|Secondary|Change From Baseline in Blood Pressure at the Indicated Time Points|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from investigational product (IP; up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1261360|NCT00424255|Secondary|Number of Participants With On-therapy and Follow-up Late Radiation Morbidity Events|Late radiation morbidity event data are summarized as the number of participants with late radiation morbidity events per system organ class (SOC). Late radiation effects are defined as those that first occur 90 days or more after the initiation of radiation therapy.|From 180 days after completion of radiation until the last follow-up/withdrawal visit (average of 64 study weeks)|Safety Population|||Participants|||Number
1261361|NCT00424255|Secondary|Number of Participants With the Indicated Hematological Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit|Data are summarized using the NCI CTC version 3.0 toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated hematological parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit. Hematology parameter included: hemoglobin, total neutrophils (TN), platelet count (PC), and White Blood Cell (WBC) count.|From Baseline (within 8 weeks prior torandomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1261362|NCT00424255|Secondary|Number of Participants With the Indicated Chemistry Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit|Data are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI CTC version 3.0) toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated chemistry parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: albumin, alkaline phosphatase (AP), alanine amino transferase (ALT), aspartate amino transeferase (AST), total bilirubin (TB), calcium, carbon dioxide content/bicarbonate (CO2/HCO3), creatinine, glucose, potassium, and sodium. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit.|From Baseline (within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1261363|NCT00424255|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of non-serious AEs occurring at a frequency threshold of 5% and SAEs.|From the first dose of lapatinib/placebo until 5 days after the last dose (average of 141 study weeks)|Safety Population|||Participants|||Number
1261364|NCT00424255|Secondary|Extent of Exposure|Extent of exposure is defined as the duration of treatment administered during the study. The mean duration of treatment is calculated as the number of days between the start of treatment and the end of treatment inclusive (i.e., treatment stop date minus treatment start date + 1). Participants were counted in a treatment phase (monotherapy, chemoradiotherapy, and maintenance) if they had received any dose in that phase. Participants randomized to placebo who received >=1 dose of lapatinib in error were included in the lapatinib arm.|From randomization until end of 1year maintenance treatment (average of 63 study weeks)|Safety Population (SP): all participants (par.) who were randomized and took >=1 dose of study medication. Only par. available at the specified time points were analyzed (represented by n=X, X in the category titles). Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.|||Weeks||Standard Deviation|Mean
1261365|NCT00424255|Secondary|Number of Participants With a Second Primary Tumor|Participants who developed a second primary tumor at the time of the first recurrence or within 28 days of the first recurrence were measured. The criteria for a second primary tumor are as follows: a distinct lesion separated from the primary tumor site by >2 centimeters of normal epithelium; or a new cancer with different histology; or any cancer, regardless of site, occurring >=3 years after initial treatment. Participants with baseline disease were included in the denominator when calculating the percentage.|From randomization until development of second primary tumor or within 28 days of first recurrence (average of 101 study weeks)|ITT Population|||Participants|||Number
1261366|NCT00424255|Secondary|Time to Distant Relapse (TTDR)|TTDR is defined as the time from randomization until the first occurrence that distant relapse is documented. Distant relapse is defined as clear evidence of distant metastases (lung, bone, brain, etc.). Metastasis is defined as the spread of a cancer from one organ or part to another non-adjacent organ or part. All other events prior to a distant relapse were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.|From randomization until the first documented occurrence that distant relapse is documented (average of 101 study weeks)|ITT Population|||Months||95% Confidence Interval|Median
1261367|NCT00424255|Secondary|Time to Locoregional Recurrence (TTLR)|TTLR is defined as the time from randomization until the first occurrence that local and/or regional recurrence is documented or the date of censor. Local relapse is defined as recurrent cancer in the primary tumor bed not clearly attributable to a second primary neoplasm. Regional relapse is defined as recurrent cancer in the neck not clearly attributable to a second primary neoplasm. All other events prior to locoregional recurrence were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.|From randomization until thefirst occurrence that local and/or regional recurrence is documented or the date of censor (average of 101 study weeks)|ITT Population|||Months||95% Confidence Interval|Median
1261368|NCT00424255|Secondary|Disease Specific Survival (DSS)|DSS is defined as the time from randomization until death due to head and neck cancer. Participants whose death was not related to the disease under study were treated as competing risks at the time death occured. Participants who were alive were censored at the time of their last visit.|From randomization until death due to head and neck cancer (average of 131 study weeks)|ITT Population|||Months||95% Confidence Interval|Median
1261369|NCT00424255|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. For participants who did not die, the time to death was censored at the time of last visit/contact.|From randomization until death due to any cause (average of 131 study weeks)|ITT Population|||Months||95% Confidence Interval|Median
1261395|NCT00424047|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)|OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|Randomization to data cut off of 02 March 2008; up to 51 months|Intent to Treat population includes all participants who were randomized.|||weeks||95% Confidence Interval|Median
1261370|NCT00424255|Primary|Disease Free Survival (DFS)|DFS is defined as the time from randomization until the earliest date of disease recurrence (evidence of local, regional, or distant disease progression, second primary tumor) or death due to any cause. Disease recurrence was based on the assessments from the blinded, independent reviewer (radiological and clinical). Participants who initiated alternative anti-cancer therapy prior to disease recurrence or death were treated as censored at the last assessment prior to the time of this initiation. For participants whose disease did not recur or who did not die, DFS was censored at the time of the last independently assessed radiological scan (where initiation of alternative anti-cancer therapy had not commenced). Participants who missed two or more consecutive disease assessments were censored at the last assessment prior to the missed assessments. Participants considered to have malignant disease at Baseline were censored at the time of randomization.|From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, irrespective of whether they actually received study medication|||Months||95% Confidence Interval|Median
1261371|NCT00424190|Secondary|Assess Safety|Comparisons of the number of participants with Adverse Events|First dose of study drug through TOC visit|||||||
1261372|NCT00424190|Secondary|Microbiological Reinfection or Recurrence at the LFU Visit||21 to 35 days after the last dose of study drug|||||||
1261373|NCT00424190|Secondary|Clinical Relapse at the Late Follow Up (LFU) Visit||21 to 35 days after the last dose of study drug|||||||
1261374|NCT00424190|Secondary|Clinical and Microbiological Response by Pathogen at the TOC Visit||8-15 days after last dose of study drug|||||||
1261375|NCT00424190|Secondary|Clinical Response at the End of Therapy (EOT) Visit||Last day of study drug administration|||||||
1261376|NCT00424190|Secondary|Microbiological Success Rate at the TOC Visit||8-15 days after last dose of study drug|||||||
1261377|NCT00424190|Primary|Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug|||||||
1261378|NCT00424190|Primary|Clinical Cure Rate at Test of Cure (TOC) (MITT Population)|"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.~Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.~Indeterminate: Inability to determine an outcome"|8-15 days after the end of treatment|MITT (Modified Intent to Treat) - Any randomized subjects that received any amount of study drug|||participants|||Number
1261379|NCT00424177|Secondary|Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score|ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding|Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)|Participants who responded in Cycle 1|||participants|||Number
1261380|NCT00424177|Secondary|Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale|World health Organization (WHO) Bleeding Scale Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross blood loss, Grade 4 = debilitating blood loss.|Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)|Participants who responded in Cycle 1|||participants|||Number
1261381|NCT00424177|Secondary|Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up|Change in participants' anti-platelet antibody levels was measured as the number of samples positive for at least 1 glycoprotein from baseline to follow-up. Serum glycoprotein-specific antigens: GPIIb/IIIa, Ib/IX, and Ia/IIa|Up to 1 year|Safety Population: any participant who received at least 1 dose of study medication|||participants|||Number
1261382|NCT00424177|Secondary|Number of Participants Who Required Rescue Medication|New idiopathic thrombocytopenic purpura (ITP) medication, increase dose of a concomitant ITP medication from baseline, platelet transfusion, and/or splenectomy|Up to 3 cycles of treatment including follow-up visits following last dose of eltrombopag|ITT Population|||participants|||Number
1261383|NCT00424177|Secondary|Changes in Participants' Platelet Counts During 3 Cycles of Treatment|Changes from baseline, during on-therapy periods of a cycle, during off-therapy periods of a cycle, and within 4 weeks of permanent discontinuation of eltrombopag treatment.|Up to 1 year|Intent-to-Treat (ITT) Population: All participants who were dispensed study medication|||Gi/L||Full Range|Median
1261384|NCT00424177|Secondary|Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6.|CBC, platelet counts|Up to 42 days of dosing|Cycle 1 responders|||participants|||Number
1261385|NCT00424177|Primary|Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1|Complete blood count, platelet count by blood draw|Day 42 of each cycle|Primary Analysis Population: All participants who entered the study, received at least 1 dose of eltrombopag, and responded in Cycle 1|||participants|||Number
1261386|NCT00424047|Post-Hoc|Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)|Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.|Up to data cut off of 03 Mar 2008; up to 51 months|Intent to Treat population includes all participants who were randomized to study drug.|||weeks||95% Confidence Interval|Median
1261396|NCT00424047|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|Randomization to data cut off of 03 August 2005; up to 24 months|Intent to Treat population includes all participants who were randomized.|||weeks||95% Confidence Interval|Median
1269964|NCT00360334|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
1261387|NCT00424047|Secondary|Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)|The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.|Randomization to cut off date of 02 March 2008; up to 51 months|Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.|||weeks||95% Confidence Interval|Median
1261388|NCT00424047|Secondary|Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale|The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.|Randomization to cut off date of 03 August 2005; up to 24 months|Intent to Treat includes all participants who were randomized to study drug; a total of six ECOG scores were missing at the time of the Aug 2005 cut-off.|||weeks||95% Confidence Interval|Median
1261389|NCT00424047|Primary|Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)|Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|From randomization up to cut-off date of 02 March 2008; up to 51 months|Intent to treat included all participants who were randomized.|||weeks||95% Confidence Interval|Median
1261390|NCT00424047|Post-Hoc|Kaplan-Meier Estimate of Duration of Response|Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.|Up to data cut off of 03 August 2005; up to 24 months|Intent to Treat population includes all participants who were randomized to study drug.|||weeks||95% Confidence Interval|Median
1261391|NCT00424047|Secondary|Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)|Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).|Up to unblinding data cut off of 03 August 2005; up to 24 months|Analysis not performed due to an insufficient number of participants with SRE|||participants|||Number
1261392|NCT00424047|Secondary|Number of Participants With Adverse Events (AE)|"An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.~The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death."|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months|The safety population includes all participants who received at least one dose of study drug regimen|||participants|||Number
1261393|NCT00424047|Secondary|Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)|Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.|Randomization to data cut-off of 02 Mar 2008; up to 51 months|Intent to Treat Population includes all participants who were randomized|||percentage of participants|||Number
1261394|NCT00424047|Secondary|Summary of Myeloma Response Rates Based on Best Response Assessment|Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.|Randomization to 03 August 2005; up to 24 months|Intent to Treat Population includes all participants who were randomized|||percentage of participants|||Number
1262670|NCT00414453|Secondary|Short-Form McGill Pain Questionnaire|Subject completes short form McGill Pain questionaire|Occurs Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
1261397|NCT00424047|Primary|Kaplan-Meier Estimate of Time to Tumor Progression (TTP)|Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|From randomization up to cut-off date of 03 August 2005; up to 24 months|Intent to treat included all participants who were randomized.|||weeks||95% Confidence Interval|Median
1261398|NCT00424021|Primary|Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.|||Participants|||Number
1261399|NCT00424021|Primary|Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.|||Participants|||Number
1261400|NCT00424021|Secondary|Long-term Survival|Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study) was evaluated during the AMB-220-E study period.|||Probability (%)|||Number
1261401|NCT00424021|Secondary|Failure-free Treatment Status|Failure-free treatment status was defined as the time from initiation of active treatment to the first occurrence of death, lung transplantation, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.|Week 0 (NCT00046319 baseline) to Week 360|The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the NCT00046319 study) was evaluated during the NCT00046319 and AMB-220-E study periods.|||Probability (%)|||Number
1261402|NCT00424021|Secondary|Time to Clinical Worsening of PAH|Clinical worsening of PAH was defined as death, lung transplantation, hospitalization for PAH, atrial septostomy, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Sildenafil, a type 5 phosphodiesterase (PDE-5) inhibitor, had not received regulatory approval for the treatment of PAH until late in the conduct of AMB 220 and AMB 220-E, and did not count toward clinical worsening. Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.|Week 0 (NCT00046319 baseline) to Week 360|The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the AMB-220 study) was evaluated during the NCT00046319 and AMB-220-E study periods.|||Probability (%)|||Number
1261403|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1261404|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1261405|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1261406|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1262671|NCT00414453|Secondary|Short-form Health Survey 36 (SF-36)|Subject completes short form health survey 36 questionaire|Occurs at Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
1261407|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24])|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|||Units on a Scale||Standard Deviation|Mean
1261408|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|180 weeks (Week 24 of NCT00046319 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Participants|||Number
1261409|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|132 weeks (Week 24 of NCT00046319 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Participants|||Number
1261410|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|84 weeks (Week 24 of NCT00046319 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Participants|||Number
1261411|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|24 weeks (Week 24 [baseline of AMB-220-E] to Week 48)||||Participants|||Number
1261412|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24])|Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Participants|||Number
1261413|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1261414|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1261415|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1261416|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1261417|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24])|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
1261418|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
1261419|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
1261420|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
1261421|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
1261422|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
1261423|NCT00424021|Primary|Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 334|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.|||Participants|||Number
1261424|NCT00424008|Secondary|The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period.|For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing, and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free Day/Night is defined as a combined score of 0 across the morning and evening evaluations. The proportion of 0 scores across the Baseline period, and across the 12-week treatment period, is calculated to determine the overall proportion of symptom-free Days/Nights for each of these periods.|Baseline to Week 12|"Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline proportion of symptom-free days/nights as a covariate."|||Proportion of symptom-free days/nights||Standard Deviation|Least Squares Mean
1261425|NCT00424008|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint|The Asthma Control Questionnaire (ACQ) by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period.|Baseline to Week 12|"Efficacy analyses were based on randomized subjects with Baseline and any postbaseline data (intent-to-treat principle).~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline ACQ score as a covariate."|||Scores on a scale||Standard Deviation|Least Squares Mean
1261426|NCT00424008|Secondary|Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1|PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose, the mean of which was Baseline, and at intervals from 5 min to 12 hrs postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs were done at Week 12. Change from Baseline to Week 12 evaluations were calculated using the same Day 1 predose scores for Baseline. The Week-12 evaluation consisted of AUC FEV1 scores across the 12-hour postdose interval.|Baseline to 5 minutes post-dose on Day 1|"Participants with data at Day One 5 minutes post-dose.~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate."|||Liters||Standard Deviation|Least Squares Mean
1261427|NCT00424008|Primary|The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1)||Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle). The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate.|||Liter x hour||Standard Deviation|Least Squares Mean
1261428|NCT00423943|Secondary|Change in Negative Symptoms|Change in average score, ranging from 0 (absent) to 5 (severe), on on Scale for the Assessment of Negative Symptoms (SANS) from baseline to 4-week time-point. Decreased values indicate improved clinical status (lesser symptom severity).|Baseline, 4 weeks||||units on SANS scale||Standard Deviation|Mean
1261429|NCT00423943|Secondary|Change in Positive Symptoms|Change in Average score (range 0-5) on the Scale for Assessment of Positive Symptoms (SAPS) from baseline to 4 week time-point, ranging from 0 (absent) to 5 (severe). Decreased values indicate improved clinical status (lesser symptom severity).|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1261430|NCT00423943|Primary|Gamma Power Change in Count of Clusters|Power in Gamma frequency range by scalp electrophysiology after single-dose and after 4-week treatment: Count of Clusters (defined as those with statistically-significant Task-Related Increase, i.e. relatively larger value of wavelet coefficient in wavelet analysis of signal) for high-control (i.e. difficult) condition versus Low-control (i.e. easy) condition, in Oscillatory Power in Time-Frequency Spectrogram. Increased values indicate improved function.|4 weeks|2 subjects in the Drug arm refused to perform EEG.|||Count of Positive Power Clusters||Standard Deviation|Mean
1261431|NCT00423943|Primary|Control-related BOLD Signal Change in Locus Coeruleus|BOLD signal change on high-control (i.e. difficult) condition versus low-control (i.e. easy) condition, on Preparing to Overcome Prepotency Task, measured by fMRI after 4-week treatment.|4 weeks||||beta coefficient of BOLD signal change||Standard Deviation|Mean
1261432|NCT00423943|Primary|Percent Change in Accuracy on High-control (i.e., Difficult) Condition of Preparing to Overcome Prepotency Task|Accuracy change on high-control (i.e., difficult) condition of Preparing to Overcome Prepotency (POP) Task. For high-control condition (red-cue), subjects responded in the incongruent direction (eg, for a right-pointing arrow, press the left button, and vice versa). Increased values indicate improved performance.|Baseline, 4 weeks||||percent change in accuracy||Standard Deviation|Mean
1261433|NCT00423930|Secondary|Overall Survival Rate: Percentage of Participants Who Survived||2 years||||percentage of participants||95% Confidence Interval|Number
1261434|NCT00423930|Primary|Progression-free Survival at 2 Years|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Percentage of Participants Experiencing Progression-free Survival at 2 Years||||percentage of participants||95% Confidence Interval|Number
1261435|NCT00423917|Secondary|Duration of Response/Time to Disease Progression in Patients With Measurable Disease|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 5 years|Evaluable patients with measurable disease who experienced a confirmed response.|||months||95% Confidence Interval|Median
1261436|NCT00423917|Secondary|Time to First Cytotoxic Agent|Time to first dose of a cytotoxic agent is defined to be the time from the date of registration to the date at which a patient recieves the first dose of a cytotoxic agent. The distribution of time to first dose of a cytotoxic agent will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years||||months||95% Confidence Interval|Median
1262672|NCT00414453|Secondary|Beck Depression Inventory|Subject completes Beck questionaire|occurs at Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
1261437|NCT00423917|Secondary|Objective Response Rate as Measured by RECIST Criteria in Patients With Measurable Disease|A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
1261438|NCT00423917|Secondary|Quality of Life, as Measured by the Largest Mean Change in LASA Overall QOL and Physical Well-being Items|Quality of life (QOL) assessment will be a secondary exploratory component of this trial. QOL of patients was measure using the 6-item Linear Analogue Self-Assessment (LASA).The LASA consists of six single-item numeric analog scales measuring overall QOL; mental, physical, emotional, and spiritual well-being; and level of activity each on a scale of 0 ('As bad as it can be') to 10 ('As good as it can be') during the past week. Items were transformed to a 0 (worst QOL or well-being) to 100 (best QOL or well-being) scale for statistical analysis. Mean change from baseline of the largest mean change in overall QOL and physical well-being are reported below.|Up to 5 years||||mean change in LASA QOL scaled score||Standard Deviation|Mean
1261439|NCT00423917|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years||||months||95% Confidence Interval|Median
1261440|NCT00423917|Secondary|Progression Free Survival|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 5 years||||months||95% Confidence Interval|Median
1261441|NCT00423917|Primary|Six-month Progression-free Survival (PFS) Rate at 6 Months|The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Additionally, if some patients are lost to follow-up not having been observed for at least 6 months, an estimate and 95% confidence interval for the 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 6 months||||percentage of patients||95% Confidence Interval|Number
1261442|NCT00423891|Secondary|Number of Participants With Electrolyte Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: DAIDS Version 1.0 and modified World Health Organization (WHO) for chloride. Milliequivalents per liter (mEq/L); Grade (Gr). Chloride high (mEq/L): Gr1: 113-<117; Gr2: 117-<121; Gr3: 121-125; Gr4: >125. Potassium low (mEq/L): Gr1: 3.0-3.4; Gr2: 2.5-2.9; Gr3:2.0-<2.4; Gr4: <2.0. Potassium high: Gr1; 5.6- <6.0; Gr2: 6.1-<6.5; Gr3: 6.6-7.0; Gr4: >7.0. Sodium high (mEq/L): Gr1; 146-<150; Gr2: 151-<154; Gr3: 155-<159; Gr4: >=160.|Day 1 Week 120|Participants who received at least one dose of study drug, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).|||participants|||Number
1261443|NCT00423891|Secondary|Number of Participants With Chemistry Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: DAIDS Version 1.0 and modified World Health Organization (WHO). Grade (Gr). ALT: Gr1:1.25-<2.5*ULN; Gr2: 2.6-<5.0 *ULN; Gr3: 5.1-10.0*ULN; Gr4:>10.0*ULN. Aspartate aminotransferase (AST): Gr1: 1.25-<2.5*ULN; Gr2:2.6-<5.0*ULN; Gr 3: 5.1-10.0*ULN; Gr4>10.0*ULN. Alkaline phosphatase: Gr1:1.25-<2.5*ULN; Gr2: 2.6-<5.0*ULN; Gr3: 5.1-10.0*ULN; Gr4: >10.0*ULN. Lipase: Gr1:1.1-<1.5*ULN;Gr2:1.6-<3.0*ULN; Gr3: 3.1-5.0*ULN; Gr4: >5.0*ULN. Creatinine: Gr1: 1.1-1.3*ULN; Gr2: 1.4-<1.8*ULN; Gr3: 1.9 - <3.4*ULN; Gr4: >=3.5*ULN. Glucose mg/dL (high): Gr1:110-<125 (Fasting)/116-<160;Gr2:126-<250 (F)/161-<250; Gr3: 251-500; Gr4: >500.Glucose (low): Gr1: 55-64; Gr2: 40 - <54; Gr3: 30-39; Gr4: <30 mg/dL.|Day 1 to Week 120|Participants who received at least one dose of study drug, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).|||participants|||Number
1261444|NCT00423891|Secondary|Number of Participants With Hematology Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: Division of AIDs (DAIDS) grades Version 1.0. Upper limit of normal (ULN); lower limit of normal (LLN); Cells per Liter (c/L); cells per microliter (c/µL); grams per deciliter (g/dL); milliequivalents per liter (mEq/L); cells per microliter (c/µL): Grade (Gr). Hemoglobin g/dL: Gr1:10.0-10.9;Gr2: 9.0-9.9; Gr3:7.0-8.9; Gr4: <7.0. International normalization ratio (INR): Gr1:1.1-<1.5*ULN; Gr2: 1.6-<2.0*ULN; Gr3: 2.1-3.0*ULN;Gr4: >3.0*ULN. Neutrophils/bands c/µL: Gr1;1.0-1.3*10^3; Gr2: 0.75-0.99*10^3; Gr 3: 0.50-0.749*10^3; Gr4: <0.5*10^3.|Day 1 to Week 120|Participants who received at least 1 dose of study therapy, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).|||participants|||Number
1261560|NCT00423267|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B|"Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.~Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication."|12 months||||Participants|||Number
1261445|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Without HBeAg Seroconversion, Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN. HBe seroconversion: loss of HBeAg (HBeAg negative) with positive HBeAb. The method used for the detection of HBeAg/Ab serologies was the DiaSorin enzyme immunoassay kit.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261446|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Plus HBeAg Seroconversion Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN. HBe seroconversion was determination of presence of HBeAb and loss of HBeAg. The method used for the detection of HBeAg seroconversion was the DiaSorin - Anti HBe enzyme immunoassay kit.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261447|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261448|NCT00423891|Secondary|Number of Participants With HBV DNA by PCR Categories at Weeks 48 and 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLQ = 29 IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline, Week 48, Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261449|NCT00423891|Secondary|Alanine Aminotransferase (ALT) Normalization From Baseline Through Week 96 in Treated Participants|Normalization in ALT= ALT ≤ 1.0*upper limit of normal (ULN). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261450|NCT00423891|Secondary|Mean Log10 Change From Baseline in HBV DNA Using Roche COBAS TaqMan - HPS Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. HBV DNA log10 changes from baseline were summarized over time.|Baseline to Week 96|Participants who received at least one dose of study drug, and had a measurement at baseline and at the specific analysis week.|||IU/mL||Standard Error|Mean
1261451|NCT00423891|Secondary|Number of Participants Who Had a Protocol Defined Response (PDR) Through Week 96 in Treated Participants|PDR was defined as confirmed HBV DNA < 50 IU/mL plus confirmed HBeAg seroconversion on 2 sequential measurements at least 14 days apart. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261452|NCT00423891|Secondary|Number of Participants With HB s Antigen (HBsAg) Seroconversion Through Week 96 in Treated Participants|HB s Ag seroconversion: loss of HBsAg (HBsAg negative) and presence of HB s antibodies (HBsAb). The method used for the detection of HBsAg seroconversion was the ADVIA Centaur iImmunoassay system. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261453|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than Lower Limit of Quantification (LLQ) for the Roche COBAS TaqMan - HPS Assay Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLQ = 29 IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261638|NCT00422903|Secondary|Mean Left Ventricular Ejection Fraction (LVEF)|Cardiac safety was evaluated as any signs or symptoms of deterioration in LVEF. LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. LVEF was evaluated using NCI CTCAE.|Baseline (Day 1), after 12 weeks, and after 24 weeks|ITT Population. Only those participants contributing data were analyzed.|||Percent volume||Full Range|Mean
1261454|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than Lower Limit of Detection (LLD) for the Roche COBAS TaqMan - HPS Assay at Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLD = 6 IU/mL). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261455|NCT00423891|Primary|Number of Participants With Serious Adverse Events (SAE) and Discontinuations Due to Adverse Events (AEs) - On Treatment|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Medical Dictionary for Regulatory Activities (MedDRA) version 16.0 was used.|Day 1 to Week 120|All participants who received at least one dose of study drug. On-treatment period began on the first day of study therapy and ended 5 days after the last dose of study therapy.|||participants|||Number
1261456|NCT00423891|Secondary|Number of Participants With Hepatitis B e Antigen Seroconversion Through Week 96 in Treated Participants|HBe seroconversion: loss of HBeAg (HBeAg negative) with positive HB e antibodies (HBeAb), ie both the presence of HBeAb and the absence of HBeAg. The method used for the detection HBeAg seroconversion was the DiaSorin - Anti HBe enzyme immunoassay kit. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261457|NCT00423891|Secondary|Number of Participants With Hepatitis B s Antigen (HBsAg) Loss Through Week 96 in Treated Participants|HBsAg loss: HBsAg negative. The method used for detection of HBsAg was the ADVIA Centaur iImmunoassay system. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261458|NCT00423891|Secondary|Number of Participants With Hepatitis B e Antigen (HBeAg) Loss Through Week 96 in Treated Participants|HBeAg loss: HBeAg negative. The method used for the detection of HBe Ag was the DiaSorin - Anti HBe enzyme immunoassay kit. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261459|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than 50 IU/mL Through Week 96 in Treated Participants|Hepatitis B virus DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS TaqMan - high pure system (HPS) assay and was reported in international units per milliliter (IU/mL). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
1261460|NCT00423891|Secondary|Mean Apparent Total Body Clearance (CLT/F) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|CLT/F was calculated by dividing the dose of ETV by AUC(TAU) of ETV and was measured in liters per hour (L/h). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|At 2 weeks|Participants in Groups A and B who received study drug and had PK assessment.|||L/h||Standard Deviation|Mean
1261461|NCT00423891|Secondary|Mean Area Under the Concentration-Time Curve in One Dosing Interval [AUC(TAU)] of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|Area under the Curve (AUC) was derived from plasma concentration of ETV versus time. AUC(TAU) was calculated by log- and linear trapezoidal summations, TAU = 24 hours, and was measured in nanograms*hours per milliliter (ng*h/mL). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1261462|NCT00423891|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) in LVD-naive and LVD-experienced Participants, by Age Cohort|Tmax was derived from plasma concentration of ETV versus time and measured in hours (h). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. Age categories presented below: participants age as of first day of dosing. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.|||h||Full Range|Median
1261463|NCT00423891|Secondary|Mean Maximum Observed Plasma Concentration (Cmax) and Mean Trough Observed Plasma Concentration (Cmin) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|Cmax and Cmin were derived from plasma concentration of ETV versus time and measured in nanograms per milliliters (ng/mL). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. Note: PK parameters were summarized for only Groups A and B. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1261464|NCT00423878|Secondary|Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)||Measured at Month 6|2 participants who never took assigned study medication were excluded.|||participants|||Number
1261465|NCT00423878|Primary|Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks|Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.|24 weeks|The primary efficacy analysis was conducted on the efficacy evaluable population, defined as all patients randomly assigned to a study group who received at least one dose of study medication and completed at least one post-baseline efficacy assessment.|||mg/dL non-HDL cholesterol||Standard Error|Least Squares Mean
1261466|NCT00423852|Primary|Maximum Tolerated Dose of Ifosfamide||4 years||||mg/m2|||Number
1261467|NCT00423852|Primary|Response|"Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary)~Complete Response (CR): A complete response is defined as one of the following:~Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy).~Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks.~Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks."|2 year||||participants|||Number
1261468|NCT00423813|Primary|Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).|Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.|Baseline to Week 14||||Percentage of Participants|||Number
1261469|NCT00423800|Secondary|Number of Participants With a Virological Relapse|"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).~Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment."|24 weeks following completion of 24 or 48 weeks of therapy|ITT population that completed the study.|||Participants|||Number
1261470|NCT00423800|Primary|Number of Participants With a Sustained Virologic Response|"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.~Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder."|24 weeks following completion of 24 or 48 weeks of therapy||||Participants|||Number
1261471|NCT00423735|Secondary|Correlation of Pharmacokinetic Data With Dosing, Toxicity, and Efficacy|Sufficient pharmacokinetic data was not obtained.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|||||||
1261472|NCT00423735|Secondary|Correlation of Molecular Markers and Tumor Response|The following markers were examined: p-SRC, PDGFR, EPHA2, c-KIT. Patients were categorized based on the number of positive molecular markers they had: 2 vs. 3 and 4. Correlation of marker category and best tumor response was tested using Fisher’s exact test. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression up to six months. Patients are combined from the two treatment arms.|From registration to 6 months|Eligible patients who started study treatment and whose response was assessed|||Participants|||Count of Participants
1261473|NCT00423735|Secondary|Rate of Adverse Events|The rate of patients' worst overall grade of adverse event is reported. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started protocol treatment|||percentage of participants|||Number
1261698|NCT00422383|Secondary|Percentage of Participants With Positive Recall Antigen Antibody Titers|A positive titer result to recall antigens was defined as a serum antibody level equal to or above the following protective levels: tetanus toxoid ≥ 0.1 IU/mL, influenza A > 12 U/mL, influenza B > 12 U/mL, and streptococcus (S.) pneumococcus ≥ 1.0 mg/L.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1261474|NCT00423735|Secondary|Progression-free Survival|Progression-free survival time is measured from randomization to the date of first progression or death, else the last follow-up date on which the patient was reported alive, and is estimated by the Kaplan-Meier method. Progression is defined as ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment|||months||95% Confidence Interval|Mean
1261475|NCT00423735|Secondary|Treatment Response Rates at Six Months|Best response is assessed using standard criteria for patients with malignant gliomas (Macdonald 1990) as reported by the site. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; neurologically worse; steroids stable/increased. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression, up to six months. The study is not designed for a comparison of the treatment arms to each other.|From registration to 6 months|Eligible patients who started study treatment|||percentage of participants|||Number
1261476|NCT00423735|Secondary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months. Arms are not compared.|||months||95% Confidence Interval|Median
1261477|NCT00423735|Secondary|Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS)|Study design and efficacy determination uses the hybrid endpoint of 6mPFS or complete/partial response of any duration prior to or at 6 months. Null hypothesis = 11%; alternative hypothesis = 25%. Simon’s minmax 2-stage design was used with type I and type II error both set at 10%. Stage 1 and 1B: If 2 or fewer patients were alive and progression-free at 6 months or achieved complete/partial response, then there would be no further accrual and the alternative hypothesis would be rejected. Otherwise accrual would continue to a total of 50 analyzable patients to address the primary endpoint. Complete Response: Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial Response: ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved.|Registration to 6 months|Eligible patients who started protocol treatment.|||participants|||Number
1261478|NCT00423735|Primary|Number of Patients Achieving 6-month Progression-free Survival (6mPFS)|This study utilized a two-stage phase II design (Stage 1B and 2). The primary endpoint of 6-month progression-free survival (6mPFS) would be assessed based on the patients combined from 1B and 2 if the study continued to Stage 2. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. If the first stage met its criteria (see secondary outcome measure), then accrual would continue, otherwise there would be no further accrual and the alternative hypothesis would be rejected. Following Stage 2 accrual completion and 6 months of follow-up, if 9 or more patients were alive without progression by 6 months, the null hypothesis would be rejected in favor of the alternative.|Registration to 6 months|Eligible patients who started protocol treatment.|||participants|||Number
1261479|NCT00423722|Secondary|Change in Dehydration as Measured by Dehydration Assessment Scale|Dehydration was assessed by using the Dehydration Assessment Scale on the basis of three physical findings, moisture on the mucous membranes of the mouth (0=moist, 1=somewhat dry, 2=dry), axillary moisture (0=moist, 1=dry) and sunkenness of the eyes (0=normal, 1=slight sunken, 2=sunken). These signs are selected due to their significant correlations with biological dehydration, as previously confirmed by elderly patients. The dehydration score (range 0-7) is calculated as the total of these 3 scores, a higher score indicates a higher level of dehydration. The reported value was the mean of average change in patients' scores per group.|Baseline to Day 7||||units on a scale||Standard Deviation|Mean
1261480|NCT00423722|Secondary|Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)|Secondary outcomes included delirium, quality of life, and overall survival. The Nursing delirium screening scale (NuDESC) was used to assess delirium. NuDESC is a validated observational instrument conducted by research staff based on input from family caregivers. Five symptoms (disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation) are each given a score from 0 to 2, for a possible total score of 10. A higher NuDESC score indicates increased symptoms of delirium. It was observed a trend for lesser decline (delirium) in the hydration group, and significant worsening of night-time NuDESC scores in the placebo group.|Baseline to Day 7 (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)||||units on a scale||Inter-Quartile Range|Mean
1261481|NCT00423722|Secondary|Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7|"Change between Day 7 to Baseline in FACIT-F (Functional Assessment of Chronic illness Therapy-Fatigue) & FACT-G (Functional Assessment of Cancer Therapy-General) scores. Participants rate quality of life using FACT-G consisting of 33 questions with 5 domains assessing physical and social, emotional & functional well being & relationship with physician, remaining 5 assess extent to which each domain affects overall quality of life on 5-point scale from 0 (not at all) to 4 (very much); total score obtained by summing individual subscale scores (0-132). FACIT-F consists of 13 items where participants rate intensity of fatigue & its related symptoms on a scale of 0-4 from 0 not at all to 4 very much. The responses to FACIT fatigue questionnaire are each measured on 4‐point Likert scale with total score ranges from 0 to 52. High scores represent less fatigue. Reported is the mean change of the summed value of all reported scores for the FACT-G or the FACIT-F from baseline to Day 7."|Baseline to Day 7||||units on a scale||Standard Deviation|Mean
1261482|NCT00423722|Secondary|Reduced Symptom Burden as Measured by RASS, MDAS and UMRS|"Participants rated delirium, quality of life, and overall survival using Richmond agitation sedition scale (RASS) where +4 is Combative to -5 is Unarousable; Memorial delirium assessment scale (MDAS), a ten-item, clinician-rated scale from 0 (none) to 3 (severe) for severity of delirium, for a total range of 0-30; and Unified Myoclonus Rating Scale (UMRS) 5-functional scores rated 0 to 4, for a total range of 0-20 where higher scores indicate more severe involuntary movements. Higher scores indicate worse outcomes for each scale, i.e. RASS more agitation, MDAS more delirium and UMRS more severe involuntary movements. The mean represents change in combined participant daily scores for each scale between Baseline and Day 4 assessments then separately Day 7 assessments. Reported value is mean of average change in patients' scores per group. Reported values reflect changes from baseline, either median decreases (less than 0), no change (0) or increases (greater than 0)."|Baseline to Day 7||||units on a scale||Inter-Quartile Range|Median
1261483|NCT00423722|Primary|Participant Reduced Symptom Burden|Symptom burden, assessed using the Edmonton Symptom assessment scale, which has been validated in the cancer population. Participants are asked to rate the severity of their symptoms over the previous 24 hours using a numerical rating scale of 0-10, with 0 meaning that the symptom is absent and 10 meaning the worst possible symptom. The mean is a composite outcome where change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations) between day 4 and baseline ranged from 0-40 daily. The reported value was the mean of average change in patients' scores per group.|From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)||||units on a scale||Standard Deviation|Mean
1261484|NCT00423683|Secondary|Resolution of PE||3 years or until death|33 participants contributed 25 PE sites in Arm 1; 31 participants contributed 18 PE sites in Arm 2. Unit of analysis was PE sites|||percentage of PE sites|Participants||Number
1261485|NCT00423683|Secondary|Resolution of DVT||3 years or until death|33 participants contributed 59 DVT sites in Arm 1; 31 participants contributed 48 DVT sites in Arm 2. Unit of analysis was DVT sites|||percentage of DVT sites|Participants||Number
1261486|NCT00423683|Secondary|Overall Survival||3 years or until death||||days||95% Confidence Interval|Median
1261487|NCT00423683|Primary|Adverse Outcomes|Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs|3 years or until death||||percentage of participants|||Number
1261488|NCT00423670|Secondary|Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR|"Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL."|At FW 24 up to EOF and at 72 weeks post randomization|Participants who achieved SVR.|||Participants|||Number
1261489|NCT00423670|Secondary|Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR|"Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At FW 12 and FW 24 up to EOF|Participants with undetectable HCV-RNA at FW 12.|||Participants|||Number
1261490|NCT00423670|Secondary|Number of Participants With an Early Virologic Response (EVR) That Achieved SVR|"Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At TW 12, and at FW 24 up to EOF|Participants with an early virologic response (EVR).|||Participants|||Number
1261491|NCT00423670|Secondary|Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization|"Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|72 weeks post randomization||||Participants|||Number
1261492|NCT00423670|Secondary|Number of Participants Negative for HCV-RNA at FW 12|"Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At FW 12|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).|||Participants|||Number
1261493|NCT00423670|Secondary|Number of Participants With SVR Based on Duration of Boceprevir Treatment|"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|From FW 24 up to EOF|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).|||Participants|||Number
1261494|NCT00423670|Secondary|Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin|"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|From FW 24 up to EOF|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).|||Participants|||Number
1261495|NCT00423670|Primary|Number of Participants With Sustained Virologic Response (SVR)|"Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL).~A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR."|From follow-up week (FW) 24 up to end of follow-up (EOF)|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).|||Participants|||Number
1261496|NCT00423657|Secondary|To Evaluate Safety||first study drug dose through TOC|||||||
1261497|NCT00423657|Secondary|To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit||21-35 days after last dose of study drug|||||||
1261498|NCT00423657|Secondary|To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit||21 to 35 days after the last dose of study drug|||||||
1261499|NCT00423657|Secondary|To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit||8-15 days after last dose of study drug|||||||
1261500|NCT00423657|Secondary|To Evaluate the Clinical Response at the End of Therapy (EOT) Visit||last day of study drug administration|||||||
1261501|NCT00423657|Secondary|To Evaluate the Microbiological Success Rate at the TOC Visit||8-15 days after the last dose of study drug|||||||
1261502|NCT00423657|Primary|The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.||8-15 days after last dose of study drug|||||||
1261503|NCT00423657|Primary|Clinical Cure Rate at Test of Cure (TOC) (MITT Population)|"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.~Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.~Indeterminate: Inability to determine an outcome"|8-15 days after last dose of study drug administration|MITT (Modified Intent to Treat) - all subjects that received any amount of study drug|||participants|||Number
1261504|NCT00423605|Primary|Number of Subjects Reporting Adverse Events|Number of subjects reporting adverse events.|Treatment Period (38 weeks)||||Participants|||Number
1261505|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Mental Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261506|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Emotional|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261507|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Social Functioning|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261508|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Vitality|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261509|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - General Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261720|NCT00422383|Secondary|Peripheral CD19+CD27+ B Cell Count in Cells/µL|Simultaneous surface expression of CD19 and CD27 was assessed by FACS analysis as a marker of memory B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261510|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Bodily Pain|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261511|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261512|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261513|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261514|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261515|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class|Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest.|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Participants|||Number
1261516|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise|Change from baseline evaluated after 12 weeks of ambrisentan therapy in Borg dyspnea index (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
1261517|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD)|The 6MWD test is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||meters||Standard Deviation|Mean
1261518|NCT00423592|Secondary|The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in dose reduction. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.|||participants|||Number
1261717|NCT00422383|Secondary|Change From BL in Peripheral CD3+ T Cell Count|Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261519|NCT00423592|Secondary|The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug.|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 5 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of drug. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.|||participants|||Number
1261520|NCT00423592|Primary|The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug.|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.|||Participants|||Number
1261521|NCT00423579|Primary|Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks|Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment.|Baseline and 6 weeks|Intent-to-treat population only.|||percentage change||Standard Deviation|Mean
1261522|NCT00423488|Primary|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint, After 6 Weeks of Treatment||6 weeks of treatment (from Baseline to Endpoint)|Intent-to-treat population only.|||percentage change||Standard Deviation|Mean
1261523|NCT00423449|Primary|Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease|"Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment.~The MTD was 400 mg for up to 10 days in 21-day cycles."|every 21 days (every cycle), up to 126 days (6 cycles)||||mg|||Number
1261524|NCT00423449|Secondary|Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)|"An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.~The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)."|every 21 days (every cycle), up to 126 days (6 cycles)||||Participants|||Number
1261525|NCT00423449|Secondary|Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)|"An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.~The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)."|every 21 days (every cycle), up to 126 days (6 cycles)||||Participants|||Number
1261526|NCT00423449|Primary|Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin|DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs.|every 21 days (every cycle), up to 126 days (6 cycles)||||Participants|||Number
1261527|NCT00423436|Primary|Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments|Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1.|Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)|Analysis was per protocol. Due to attrition, data from 61 participants were analyzed at end of first chemotherapy cycle and from 27 participants at the end of the study.|||Ratio of alerts/number of assessments|Participants||Number
1261528|NCT00423358|Secondary|Short Form 36 Survey|12 month score for physical function domain of SF36 survey; scale 0 to 100 with 0 indicating worst disability and 100 indicating best physical function|1 Year|Intent to treat analysis|||units from 0 (worst) to 100 (best)||95% Confidence Interval|Mean
1261529|NCT00423358|Secondary|Bone Mineral Density|one year change in mean total hip BMD|1 Year|Intent to treat analysis|||g/cm2||Standard Deviation|Mean
1261530|NCT00423358|Primary|Parathyroid Hormone Level|Serum parathyroid hormone level|1 Year|Subject data were analyzed using the intent to treat approach.|||pg/mL||Standard Deviation|Mean
1261664|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
1261531|NCT00423332|Secondary|Best Objective Tumour Response|Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).|Baseline, Week 12 and every 8 weeks thereafter or until progression.|For the patients who switched from placebo to cediranib after unblinding, the baseline RECIST assessment was not reset to their last scan placebo, owing to the methods of data collection; therefore, it was not possible to determine their subsequent response to cediranib treatment using a ‘best response’ summary.|||Participants|||Number
1261532|NCT00423332|Secondary|Objective Tumour Response at 12 Weeks|Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.|Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.||||Participants|||Number
1261533|NCT00423332|Secondary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|Treatment period up to 2nd data cut-off of 8th March 2009.|Comparison of PFS between patients randomised to cediranib 45 mg versus those randomised to placebo. All patients irrespective of whether they had a 12 week scan are included in this analysis. At week 12 placebo patients were able to switch to cediranib.|||Months||Full Range|Median
1261534|NCT00423332|Secondary|Duration of Response|Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.|Treatment period up to 2nd data cut-off of 8th March 2009|"For patients to be included in the analysis they had to have been evaluable for RECIST and have been a responder (Complete response (CR) or Partial Response (PR)).~13 of the 19 responders had not progressed by the data cut off so their responses are ongoing and are censored at the date of the last evaluable visit before the data cut-off."|||Months||Inter-Quartile Range|Median
1261535|NCT00423332|Secondary|Best Percentage Change From Baseline in Tumour Size During the Study|Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions|Treatment period up to Week 12 visit date for last patient in (LPI)|For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data.|||Percentage change from baseline||Standard Deviation|Mean
1261536|NCT00423332|Primary|Percentage Change From Baseline in Tumour Size at 12 Weeks|Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100|Baseline to Week 12|For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data|||Percentage change from baseline||Standard Deviation|Mean
1261537|NCT00423319|Secondary|Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All participants who received at least 1 dose of study drug|||Percent of events/patients evaluated||95% Confidence Interval|Number
1261538|NCT00423319|Secondary|Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period|Treatment guidelines were provided for jaundice and elevated results of liver function tests.|First dose of study drug (presurgery) through 30 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1261539|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx <LLN use <.8*preRx or >ULN if preRx >ULN use >2*preRx or <LLN; protein, total (g/L): If missing preRx use ≥2, or if value ≥4 or preRx =0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; creatine kinase (U/L): >5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1261540|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx <LLN use <0.75* preRx or >ULN if preRx >ULN use > 1.25*preRx or <LLN; chloride (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or <LLN; bicarbonate (mEq/L): < 0.75* LLN or >1.25*ULN, or if preRx <LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; potassium (mEq/L): < 0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx <LLN use <0.95* predose or >ULN if preRx >ULN use >1.05 *preRx or < LLN.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1261541|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; basophils (*10^3 cells/μL): >400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0;|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1261542|NCT00423319|Secondary|Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period|Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1261543|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1261544|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1261545|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Event During the Treatment Period|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1261546|NCT00423319|Secondary|Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood.|First dose of study drug (presurgery) through 30 days after the last dose of study drug|All participants who received at least 1 dose of study medication|||Participants|||Number
1261561|NCT00423267|Secondary|Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A|Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.|12 months||||Participants|||Number
1261562|NCT00423267|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B|Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.|12 months||||Participants|||Number
1261547|NCT00423319|Secondary|Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Percentage of events/patients evaluted||95% Confidence Interval|Number
1261548|NCT00423319|Secondary|Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period|VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All participants randomized to treatment|||Percentage of events/patients evaluated|||Number
1261549|NCT00423319|Secondary|Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Each patient was categorized as having no proximal DVT, having proximal DVT, being nonevaluable for proximal DVT, having no distal DVT, having distal DVT, or being nonevaluable for distal DVT. Adjudication criteria were: Normal=All deep veins were visualized, and there was no intraluminal filling defect (ILFD). ILFD=An area of reduced, or absent filling, at least partially surrounded with contrast medium in ≥ 2 projections or a lack of filling in a vessel in which there was a cut-off that had the configuration of a thrombus. Indeterminate=A lack of filling of a region of the deep vein system, proximal or distal, without the presence of an ILFD elsewhere in the same region. Not Done=A venography was not performed. Proximal DVT was found if any of the proximal veins had an ILFD. Pulmonary embolism was radiographically (angiography, V/Q scan, computed tomography) determined.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|Randomized participants with either an adjudicated event or an adjudicated evaluable bilateral venogram|||Percentage of events/patients evaluated||95% Confidence Interval|Number
1261550|NCT00423319|Primary|Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator’s standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, had an adjudicated venous thromboembolic event, or died of any cause.|||Percentage of events/patients evaluated||95% Confidence Interval|Number
1261551|NCT00423293|Secondary|Efficacy of Treatment, in Terms of Locoregional Failure, Disease-free Survival, Time to Colostomy, Colostomy-free Survival, and Overall Survival||From registration to date of failure, death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
1261552|NCT00423293|Secondary|Radiotherapy Treatment Time||From start to end of radiation therapy|||||||
1261553|NCT00423293|Secondary|Clinical Complete Response Rate||From registration to 8 and 12 weeks after treatment completion|||||||
1261554|NCT00423293|Secondary|Adverse Event Rates as Defined by CTCAE v 3.0 Within 90 Days From the Start of Study Treatment||From the start of treatment to 90 days|||||||
1261555|NCT00423293|Secondary|Reproducibility of the Intensity-modulated Radiation Therapy Technique||IMRT planning and dosing data is centrally reviewed for quality assurance|||||||
1261556|NCT00423293|Primary|Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)||From the start of treatment to 90 days|Eligible patients with adverse event information.|||percentage of participants||95% Confidence Interval|Number
1261557|NCT00423267|Secondary|Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B||12 months||||Participants|||Number
1261558|NCT00423267|Secondary|Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A||12 months||||Participants|||Number
1261559|NCT00423267|Secondary|Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B|Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.|12 months||||Participants|||Number
1262673|NCT00414453|Secondary|Daily Diary Sleep Interference Ratings|Subject identifies degree of sleep interference on a daily basis|daily|Data was not analyzed because we did not reach our enrollment goal and the study was terminated.. Data was not analyzed because we the data is locked and is not available.||||||
1261564|NCT00423267|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A|"Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.~Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication."|12 months||||Participants|||Number
1261565|NCT00423189|Secondary|Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab|Safety of combination therapy with verteporfin PDT and ITV ranibizumab was not determined due to lack of efficacy.|1 Year|||||||
1261566|NCT00423189|Secondary|Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months|Choroidal perfusion as assessed by ICG angiography at 1, 2, 3, 6, and 12 months was not determined due to lack of efficacy|1 Year|||||||
1261567|NCT00423189|Secondary|OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)|OCT 3 macular thickness improvement at Baseline-1month, 2months, 3months, 6months &12 months was not determined due to lack of efficacy.|1 Year|||||||
1261568|NCT00423189|Secondary|Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months|Number of intravitreal injections with ranibizumab needed by patients at 12 months was not determined due to lack of efficacy.|1 Year|not determined due to lack of efficacy||||||
1261569|NCT00423189|Primary|Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)|Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.|1 Year|As per subjects participated|||participants|||Number
1261570|NCT00423176|Primary|Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline|A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.|29-day Treatment Period and 2-week no-treatment Follow-up Period.|Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.|||Percentage of opacification||Standard Deviation|Mean
1261571|NCT00423176|Primary|Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.|The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.|29-day Treatment Period and 2-week no-treatment Follow-up Period.|Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.|||Units on a scale||Standard Deviation|Mean
1261572|NCT00423150|Primary|Tumor Responses (Complete and Partial Response)|"Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first|"Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants).~Complete response is defined as disappearance of all target lesions.~Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|||Participants|||Number
1261573|NCT00423098|Secondary|Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)|BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].|From Baseline to week 4, week 12 and week 24|Intent-to-treat (ITT) populationincluded all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.|||Units on a scale||Standard Deviation|Mean
1261574|NCT00423098|Secondary|Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)|SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.|From Baseline to week 4, week 12 and week 24|Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.|||Units on a scale||Standard Deviation|Mean
1261575|NCT00423098|Secondary|Number of Patients With Treatment Failure|Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.|12 Weeks and 24 Weeks|Safety Population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||participants|||Number
1261718|NCT00422383|Secondary|Peripheral CD3+ T Cell Count in Cells/µL|Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261576|NCT00423098|Secondary|Number of Patients With Adverse Events and Infections|Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|24 weeks|Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||participants|||Number
1261577|NCT00423098|Secondary|Duration of Exposure to Study Medication|The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.|24 weeks|Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||days||Standard Deviation|Mean
1261578|NCT00423098|Secondary|Number of Patients With Moderate to Severe Flares|A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)|12 and 24 weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||participants|||Number
1261579|NCT00423098|Secondary|Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)|Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.|12 Weeks and 24 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||mg/kg||Standard Deviation|Mean
1261580|NCT00423098|Secondary|Number of Patients With Partial Remission|Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.|Baseline to 12 and 24 weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||Participants|||Number
1261581|NCT00423098|Secondary|Number of Patients With Complete Remission|Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.|12 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||participants|||Number
1261582|NCT00423098|Primary|Number of Patients With Complete Remission|Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.|24 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||Participants|||Number
1261583|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in Modified Crichton Scale|The Modified Crichton Scale includes a total of seven items evaluated in eight grades that assess basic activities of daily living, communication functions, psychiatric symptoms and quality of life; the total score can range from 0 to 56, with a lower score indicating better function. A negative change score indicates an improvement from baseline.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261584|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)|The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living. The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in activities of daily living while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261585|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE)|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. This outcome measured the change in MMSE from the beginning of the open-label extension phase through to Week 52 of the extension phase.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward. This population includes all patients who received at least one dose of open-label study medication and had at least one efficacy assessment on treatment in the open-label extension Phase.|||units on a scale||Standard Deviation|Mean
1261586|NCT00423085|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.|||units on a scale||Standard Deviation|Mean
1261587|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS)|MENFIS was used to assess patient cognitive and psychiatric function, and evaluates core symptoms of dementia including cognitive, motivational and emotional aspects. The total score ranges from 0 to 78. The higher the score, the greater the functional deficit. A negative change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.|||units on a scale||Standard Deviation|Mean
1261721|NCT00422383|Secondary|Peripheral CD22+ B Cell Count in Cells/µL|Surface expression of CD22 was assessed by FACS analysis as a marker of mature lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261588|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)|BEHAVE-AD was used to assess patient behavior and psychiatric symptoms. It covers symptoms in seven categories: paranoid and delusional ideation, hallucinations, activity disturbances, diurnal rhythm disturbances, aggressiveness, affective disorders and anxieties, and phobias. Caregivers rate behavioral symptoms on a 0–3 scale. The total score can range from 0 to 66, with a lower score indicating better function. A negative change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.|||units on a scale||Standard Deviation|Mean
1261589|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)|The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living (ADL). The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.|||units on a scale||Standard Deviation|Mean
1261590|NCT00423085|Primary|Overall Clinical Rating of Change From Baseline to Week 24 Measured by the Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)|"The overall clinical rating of change from baseline to week 24 measured by the 7-point CIBIC plus-J scale. The Clinician's Interview-Based Impression of Change plus Caregiver Input consists of 3 subscales: Disability Assessment of Dementia Scale, Behavioral Pathology in Alzheimer's Disease Rating Scale and Mental Function Impairment Scale, as well as the Clinician's Global Impression of Change (CGIC). Participants are scored according to the following:~Markedly improved~Moderately improved~Minimally improved~Unchanged~Minimally worse~Moderately worse~Markedly worse"|Baseline and Week 24|Intent-to-treat population utilizing LOCF.|||Participants|||Number
1261591|NCT00423085|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.|Baseline and Week 24|The Intent-to-treat population: This population includes all randomized patients who received at least one dose of study drug and had at least a baseline and any post-baseline assessment on treatment (i.e. not more than 2 days after the last known date of study drug) for one of the primary efficacy variables. LOCF was utilized.|||units on a scale||Standard Deviation|Mean
1261592|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAE(s) was not assessed.~Note: SAEs were unblinded at the Month 60 analysis."|Up to Month 60|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261593|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 48|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261594|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 36|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261595|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 24|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261596|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 18|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261597|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 12|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1286682|NCT00168831|Secondary|Change From Baseline in Eosinophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1261598|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 7|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261599|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|"NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Note: NOCD and MSC cases were unblinded at the Month 60 analysis."|Up to Month 60|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261600|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 48|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261601|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 36|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261602|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 24|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261603|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 18|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261604|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 12|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261605|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 7|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261606|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 3 AE = AE that prevented normal activity. Related AE = AE assessed by the investigator as causally related to the study vaccination.|During the 30-day period (Day 0-29) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1269965|NCT00360334|Secondary|Change in Fasting Serum Triglycerides|Change in fasting serum triglycerides from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
1261607|NCT00423046|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Day 0-6) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261608|NCT00423046|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. All solicited local symptoms were assessed as related to study vaccination.|During the 7-day period (Day 0-6) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
1261609|NCT00423046|Secondary|Number of Subjects Completing the 3-dose Vaccination Schedule||Up to Month 7|The number of subjects completing the 3-dose vaccination schedule was defined as the number of subjects who received the 3 active doses (placebo administrations are not reflected).|||Participants|||Count of Participants
1261610|NCT00423046|Secondary|Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7, 12, 18, 24, 36 and 48|Analyses were done on those subjects from the ATP cohort for immunogenicity for whom CVS samples with less than 200 erythrocytes per microliter were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1261611|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells|HPV-16 and HPV-18 Specific Memory B Cells were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay and expressed as geometric mean, minimum and maximum values of specific B-cells per million of cells.|At Month 7, 12, 18, 24, 36 and 48|Results are presented by age group in subjects with detectable B-cells (>0) at defined time points, who were HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific B-cell negative at baseline from a subset of the ATP cohort for immunogenicity.|||cells per million B-cells||Full Range|Geometric Mean
1261612|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells|"Data were expressed as geometric mean, minimum and maximum values of specific CD8 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD8 T-cells.~Analyses for further time points were not performed, as there was no response at these time points."|At Month 7, 12 and 18|Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 200 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.|||cells per million CD8 T-cells||Full Range|Geometric Mean
1261613|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells|Number of cells were expressed as geometric mean, minimum and maximum values of specific CD4 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD4 T-cells.|At Month 7, 12, 18, 24, 36 and 48|Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 500 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.|||cells per million CD4 T-cells||Full Range|Geometric Mean
1261614|NCT00423046|Secondary|Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Other oncogenic types include HPV-31 and HPV-45. Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 6, 7, 12, 18, 24, 36 and 48|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1261615|NCT00423046|Secondary|Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Other oncogenic types include HPV-31 and HPV-45. Cut-off values assessed were greater than or equal 59 EL.U/mL in the sera of subjects seronegative before vaccination.|At Month 6, 7, 12, 18, 24, 36 and 48|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.|||Participants|||Count of Participants
1261616|NCT00423046|Secondary|Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1261617|NCT00423046|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Cut-off values assessed were greater than or equal to 8 ELISA units per milliliter (EL.U/mL) for HPV-16 and greater than or equal to 7 EL.U/mL for HPV-18.|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.|||Participants|||Count of Participants
1261618|NCT00423046|Secondary|Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value|The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both HPV-16 and HPV-18.|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||Participants|||Count of Participants
1261619|NCT00423046|Secondary|Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay|Other Oncogenic Types include HPV-31 and HPV-45. Titers were measured by neutralization assay and are given as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Month 7|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity with titer greater than or equal to 40 ED50 and who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||titer||95% Confidence Interval|Geometric Mean
1261620|NCT00423046|Secondary|Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value|Other oncogenic HPV types include HPV-31 and HPV-45. The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both other oncogenic types HPV-31 and HPV-45.|At Month 7|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||Participants|||Count of Participants
1261621|NCT00423046|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies|"Titers are given as Geometric Mean Titers (GMTs). Titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.~Data for Month 7 on subjects aged 18 to 26 years are given in the outcome above as a primary outcome measure."|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||Titer||95% Confidence Interval|Geometric Mean
1261622|NCT00423046|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies|Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.|At Month 7|Analysis was performed on subjects from the According-to-Protocol (ATP) cohort for immunogenicity aged 18 to 26 years and who were seronegative by Pseudovirion (PSV) neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||titer||95% Confidence Interval|Geometric Mean
1261623|NCT00422942|Primary|Change From Baseline in Absolute B Cell CD19+ Counts in Peripheral Blood|The change from baseline in absolute B cell (CD19+) count at each visit calculated as (B cell count at visit minus B cell count at baseline) for peripheral blood.|Weeks 4, 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261624|NCT00422942|Secondary|Change From Baseline in Joint Space Narrowing (JSN) Score|Changes from baseline in modified Sharp radiographic JSN score from baseline to Weeks 24 and 48. The change in score at week X (where X=Week 24 or Week 48, as appropriate) calculated as: Change = week X score minus screening score.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261625|NCT00422942|Secondary|Change From Baseline in Erosion Score|Changes from baseline in modified Sharp radiographic erosion score from baseline to Weeks 24 and 48. The change in score at week X (where X=Week 24 or Week 48, as appropriate) calculated as: Change = week X score minus screening score.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261626|NCT00422942|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261627|NCT00422942|Secondary|Change From Baseline in ACR Core Set|The changes from baseline in the ACR core set parameters at Week 48. Change from baseline to Week 48 over time in ACR core set: SJC, TJC, physician's global assessment of disease activity, patient's global assessment of disease activity, patient's assessment of pain, HAQ, ESR, and CRP. ACR20/50/70 response: ≥20%/50%/70% improvement in SJC; ≥20%/50%/70% improvement in TJC; and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; physician's global assessment of disease activity, participant's assessment of disease activity, participant assessment of functional disability via a HAQ, and CRP at each visit.|Week 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261637|NCT00422903|Secondary|Time to Treatment Failure From the Start of the Primary Therapy|Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death for any cause.|From Baseline (Day 1) up to study withdrawal (approx. 66 months)|ITT Population. Only those participants contributing data were analyzed.|||Months||95% Confidence Interval|Median
1261628|NCT00422942|Secondary|Percentage of Participants Achieving Response by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤ 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤ 1.2 with DAS28 ≤ 5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤ 1.2 with DAS28 >5.1.|Weeks 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261629|NCT00422942|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) Score|The change in DAS28-ESR at Weeks 12, 24, 36, and 48, relative to baseline. DAS28-ESR was calculated from SJC and TJC using 28-joint count, ESR (millimeters per hour [mm/hour]) and patient global assessment of disease activity (participant-rated arthritis activity assessment). Total score range: 0-9.4, higher score equals (=) more disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR <2.6 = remission.|Weeks 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261630|NCT00422942|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (20%) 50%, and 70% (ACR20/50/70) Response|ACR20/50/70 response is greater than or equal to (≥) 20%, 50%, or 70% improvement, respectively, in tender joint count (TJC) and swollen joint count (SJC); and improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261631|NCT00422942|Secondary|Change From Baseline in Myelocytomatosis Oncogene (C-myc) and BCL2-associated X Protein (BAX) in Peripheral Blood|The change in ribonucleic acid (RNA) expression of markers of apoptosis (C-myc and BAX) in peripheral blood at Days 15 and 183, relative to baseline.|Days 15 and 183|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261632|NCT00422942|Secondary|Change From Baseline in Levels of Key Cytokines in (IL-1β, TNF-α, IL-6, and IL-10) in Synovial Tissues|The change in levels of key cytokines in (IL-1β, TNF-α, IL-6, and IL-10) in synovial tissues at Weeks 12, 24, and 36, relative to baseline.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261633|NCT00422942|Secondary|Change From Baseline in Levels of Key Cytokines (Interleukin [IL]-1beta [β], Tumor Necrosis Factor [TNF]-Alpha [α], IL-4, IL-6, IL-10, and IL-13) in Blood (Serum)|The change in levels of key cytokines (IL-1β, TNF-α, IL-4, IL-6, IL-10, and IL-13) in blood (serum) on Days 15 and 183 and at Weeks 4, 12, 24, 36, and 48, relative to baseline.|Days 15 and 183 and Weeks 4, 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261634|NCT00422942|Secondary|Change From Baseline in Absolute Counts of Cells Expressing CD20+ and CD22+ in Absolute B Cell (CD19+) Counts in Peripheral Blood|The change in absolute counts of cells expressing the key B cell markers (CD20+ and CD22+) in absolute B cell (CD19+) counts in peripheral blood at Weeks 4,12, 24, 36, and 48, relative to baseline.|Weeks 4,12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261635|NCT00422942|Secondary|Change From Baseline in Absolute Counts of Cells Expressing CD20+ and CD22+ in Absolute B Cell (CD19+) Counts in Synovial Tissues|The change in absolute counts of cells expressing the key B cell markers (CD20+ and CD22+) in absolute B cell (CD19+) counts in synovial tissues at Weeks 12, 24, and 36, relative to baseline.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261636|NCT00422942|Primary|Change From Baseline in Absolute B Cell Cluster Differential 19 Positive (CD19+) Counts in Synovial Tissues|The change from baseline in absolute B cell (CD19+) counts at each visit calculated as (B cell count at visit minus B cell count at baseline) for synovial tissues.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
1261676|NCT00422656|Secondary|Treatment-Related Grade 3-4 Adverse Event Rate|The percentage of patients experiencing treatment-related grade 3-4 adverse events based on CTCAEv3 as reported on case report forms.|Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+).|The analysis dataset is comprised of all enrolled patients.|||percentage of patients||90% Confidence Interval|Number
1261639|NCT00422903|Secondary|Number of Participants With the Indicated Adverse Events With a Classification of >=Grade 2|Toxicity was measured in grades (severity of the AE) as per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening/disabling; Grade 5, death related to the AE. Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, and hypertension is high blood pressure.|From Baseline (Day 1) up to 6 months (until definitive surgery)|ITT Population. Only those participants contributing data were analyzed.|||participants|||Number
1261640|NCT00422903|Secondary|Percentage of Participants With Conversion From Planned Mastectomy at Baseline to BCS at Surgery|The percentage of participants who were planned to undergo a mastectomy at baseline but later underwent BCS was measured.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.|||percentage of participants|||Number
1261641|NCT00422903|Secondary|Number of Participants With the Indicated Type of Surgery|Mastectomy is the medical term for the surgical removal of one or both breasts. Breast-conserving surgery (BCS) involves removing only the affected part of the breast tissue during surgery, as opposed to removal of the entire breast.|At the point of definitive surgery (up to 6 months after Baseline 1)|ITT Population. Only those participants contributing data were analyzed.|||participants|||Number
1261642|NCT00422903|Secondary|Number of Participants With the Indicated Nodal Status at Surgery|The nodal status of cancer indicates the involvement of lymph nodes in the participant with cancer. N0 indicates no involvement of lymph nodes, and N+ indicates involvement of lymph nodes.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.|||participants|||Number
1261643|NCT00422903|Secondary|Number of Participants With Breast Tumors Per Pathological Stage at Surgery|Tumors were categorized as follows: T0, no evidence of primary tumor, but carcinoma of the milk ducts, accumulation of abnormal cells in the breast lobules, or Paget disease (cancer condition that appears like a skin disease involving the breast nipple) with no associated tumor mass; T1, tumor was <=2 centimeters (cm) across; T2, tumor was >2 cm but <5 cm across; T3, tumor was >5 cm across; T4, tumor of any size growing into the chest wall or skin, including inflammatory breast cancer.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.|||participants|||Number
1261644|NCT00422903|Secondary|Percentage of Participants With Pathological Complete Response (pCR) in the Breast and Axillary Nodes, Evaluated Using Miller and Payne Criteria|pCR is defined as the complete absence of infiltrating tumor cells (TCs) in the breast and lymph nodes. Miller and Payne criteria: Grade 1, no change/some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, up to a 30% loss in TCs; Grade 3, between an estimated 30% and 90% reduction in TCs; Grade 4, more than a 90% reduction in TCs, only small cluster/dispersed cells remaining; Grade 5, no malignant identifiable cells; carcinoma in the milk ducts may be present. Grades 1 and 2 = No response; Grades 3 and 4= PR; Grade 5 = CR.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population|||Percentage of participants||95% Confidence Interval|Number
1261645|NCT00422903|Primary|Percentage of Participants With Various Responses in the Breast, Evaluated Using Per Protocol Criteria|Complete clinical response=nodule not detectable; all ultrasound abnormalities detected at diagnosis have disappeared. Partial clinical response=the tumor's longest diameter (LD) is reduced by 50% or more; ultrasound characteristics of the tumor persist. Minimal response=the tumor's LD is reduced by 25%-49%. Stable disease=the tumor's LD is decreased by less than 25% and is increased by no more than 25% from the starting value. Progressive disease=the tumor's LD is increased by more than 25% from the starting value. Participants who were not evaluable did not have data available.|From Baseline (Day 1) up to 6 months, evaluated every 12 weeks|ITT Population. Three participants withdrew consent and were not included in the efficacy analysis.|||percentage of participants|||Number
1261646|NCT00422903|Primary|Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee|cOR is defined as the documented evidence of complete response (CR) and partial response (PR) as assessed by ultrasound examination using Response Evaluation Criteria In Solid Tumors (RECIST). CR is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). PR for TLs is defined as a >=30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs, it is defined as the persistence of >=1 non-TL and no new TLs or non-TLs.|From Baseline (Day 1) up to 6 months, evaluated every 12 weeks|Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of letrozole. Three participants withdrew consent and were not included in the efficacy analysis.|||percentage of participants|||Number
1261647|NCT00422812|Secondary|Survival of Headache Pain Relief|Survival for time to the first successful headache pain relief by Pain-IHS definition over the 0 to 4 hr period by treatment assigned. Pairwise comparisons were made for each of the 3 active doses to placebo. Survival Analysis (Kaplan-Meyer) was included to evaluate treatment efficacy over the 0 to 4 hr period. All tests were 2-sided with a p-value at α=0.05.|0 to 4 hours|ITT Population|||Participants|||Count of Participants
1261648|NCT00422812|Secondary|Responders, Pain-Free at 2 Hours|Percentage of Responders, Pain-Free, by Treatment Group over Time|2 hours|ITT w/ LOCF Population|||Participants|||Count of Participants
1261649|NCT00422812|Primary|Headache Pain Relief at 2 hr|Headache pain relief at 2 hr post-dose by IHS Definition (none=0 or mild=1),|2 hr post-dose|ITT w/ LOCF Population|||Participants|||Count of Participants
1261650|NCT00422799|Secondary|Duration of Response in Patients With WM|Time from documentation of first response to progressive disease.|5 Years|All participants enrolled|||years||95% Confidence Interval|Median
1261651|NCT00422799|Secondary|Time to Progression in Patients With WM|Time to progresion is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum monoclonal IgM electrophoresis confirmed by a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease or symptoms attributable to WM.|5 Years|All enrolled participants.|||years||95% Confidence Interval|Median
1261652|NCT00422799|Primary|Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated WM|Overall Response Rate= Minor response (>25%-50% reduction in monoclonal IgM from baseline + Partial Response (>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)|2 years|Participants who were previously untreated.|||Participants|||Count of Participants
1261653|NCT00422799|Primary|Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory WM.|Overall Response Rate= Minor response (>25%-50% reduction in monoclonal IgM from baseline + Partial Response (>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)|2 Years|Patients who had received at least one prior line of therapy|||Participants|||Count of Participants
1261654|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales|Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9–12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
1261655|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1–8) and Confidence (items 9–14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
1261656|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response"|The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement|||percent||Standard Error|Least Squares Mean
1261657|NCT00422734|Secondary|"Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response"|"Percent of Partners with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)"|12 weeks|all randomized participants having post-baseline data measurement on this variable|||percentage of partners answering Yes|||Number
1261658|NCT00422734|Secondary|"Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response"|"Percent of subjects with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)"|12 weeks|all randomized participants having post-baseline data measurement on this variable|||percentage of subjects answering Yes|||Number
1261659|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response|The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
1261660|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response"|The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of “yes” responses to the question during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement|||percent||Standard Error|Least Squares Mean
1261661|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response"|The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement|||percent||Standard Error|Least Squares Mean
1261662|NCT00422734|Primary|"Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3)."|The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement|||percent||Standard Error|Least Squares Mean
1261663|NCT00422734|Secondary|Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain|The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).|12 weeks|all randomized participants having post-baseline data measurement on this variable|||units on a scale||Standard Error|Least Squares Mean
1261691|NCT00422422|Secondary|Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period||Baseline to end of the 3-week evaluation period||||participants|||Number
1261692|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥12 to <16 Years||Day 21||||ug/mL||Full Range|Mean
1261665|NCT00422734|Secondary|Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
1261666|NCT00422734|Primary|Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)|The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
1261667|NCT00422734|Primary|Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)|Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
1261668|NCT00422695|Primary|Spontaneous Pain Intensity|"Pain intensity as measured with Visual Analog Scale during the time of examination.~The subjects were required to report their perceived level of pain on a 10 cm VAS scale from zero to 10 with zero being no pain and 10 representing the worst pain imaginable. Given the ease of use of this method and its current use to measure pain, VAS scales were adapted to measure patient perceived orofacial pain wherein subjects were asked to draw a vertical line at the point on the horizontal line which best represented their pain response. Where left 0 is no pain and right -10 is maximal pain."|The time of the examination|Comparison was made between control and HIV+ subjects|||units on a scale (0 to 10)||Standard Deviation|Mean
1261669|NCT00422695|Primary|Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome|"To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.~To study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:~To detect the presence of sensory aberrations in the orofacial complex;~To identify which nerve types are involved;~To identify the type of orofacial pain based on both sensory testing and clinical findings.~3.To determine psychological condition and nutrition status in patients with HIV.~4.To find associations between inherited traits and development of neuropathic pain."|Tests were performed during regular clinical visit. The test duration was about an hour|Comparisons of categorical variables were performed with Fischer’s exact test. Trends in ordered categorical variables were tested with the chi square test.|||Participants|||Number
1261670|NCT00422669|Secondary|Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up|Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
1261671|NCT00422669|Secondary|Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up|Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
1261672|NCT00422669|Secondary|The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up|LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
1261673|NCT00422669|Secondary|The Change in Six-minute Hall Walk Distance|The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
1261674|NCT00422669|Secondary|The Change in LVEF From Two Week Visit to Two Year Follow-up|Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
1261675|NCT00422669|Primary|The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up|Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
1261677|NCT00422656|Secondary|Progression Free Survival (PFS)|PFS estimated using the Kaplan-Meier method is defined as the time from registration to death from any cause or disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients alive without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.|Disease was assessed every cycle for the first 12 months and every 3 months thereafter. Median follow-up time was 19.5 months and range up to 24 months.|The analysis dataset is comprised of all enrolled patients.|||months||90% Confidence Interval|Median
1261678|NCT00422656|Secondary|Time to Progression (TTP)|TTP estimated using the Kaplan-Meier method is defined as the time from registration to disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.|Disease was assessed every cycle for the first 12 months and every 3 months thereafter. Median follow-up time was 19.5 months and range up to 24 months.|The analysis dataset is comprised of all enrolled patients.|||months||90% Confidence Interval|Median
1261679|NCT00422656|Primary|Overall Response (OR) Rate|OR rate is the percentage of patients achieving Complete Response (CR), Partial Response (PR) or Minimal Response (MR) during treatment based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003). CR: Disappearance of serum monoclonal IgM protein (IgM M-protein) by immunofixation; no histologic evidence of bone marrow (BM) involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan); PR: At least 50% reduction of IgM M-protein and at least 50% decrease in adenopathy/organomegaly on physical examination or on CT scan; and MR: At least 25% but less than 50% reduction of IgM M-protein by protein electrophoresis. Patients must have no new symptoms or signs of active disease.|Disease was assessed every cycle for the first 12 months and every 3 months thereafter. The median duration of treatment with perifosine was 5.6 months (range, 1.8- 21.5+).|The analysis dataset is comprised of all enrolled patients.|||percentage of patients||90% Confidence Interval|Number
1261680|NCT00422591|Secondary|Overall Survival (OS)|Overall Survival (OS) was calculated with Kaplan-Meier estimates. OS was calculated from the time of treatment initiation until death.|Until death or loss of follow-up||||Months||Full Range|Median
1261681|NCT00422591|Secondary|Event-Free Survival (EFS)|Event -Free Survival (EFS) EFS was calculated with Kaplan-Meier estimates. Event-free survival (EFS), defined as the time to no response to intensive induction therapy, relapse, or death of any cause, whichever comes first.|from treatment initiation until treatment failure, relapse, or death||||Months||95% Confidence Interval|Median
1261682|NCT00422591|Primary|Complete Response (CR) Rate|Complete Response (CR): Normalization of marrow (< 5% blasts; >10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count > 109/L, platelet count > 100 x 109/L).|Up to 2 months||||Participants|||Count of Participants
1261683|NCT00422513|Secondary|The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants|A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.|Baseline, Month 1 to Month 7|Safety Population|||number of participants|||Number
1261684|NCT00422513|Secondary|Number of Participants Assessed for AEs|The adverse events are captured in the adverse event and serious adverse event section of this database.|Month 1 to 15 day follow up post month 7|Safety Population|||number of participants|||Number
1261685|NCT00422513|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period|Efficacy and pharmacoeconomics analyses were not performed.|Baseline, Months 5-7|The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.|||g/dL|||Number
1261686|NCT00422513|Primary|Time Spent on Anemia Treatment Over Evaluation Period|Efficacy and pharmacoeconomics analyses were not performed.|Months 5-7|The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.|||months|||Number
1261687|NCT00422448|Secondary|Frequency of NRAS Mutations Among Nevi|All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.|30 months|All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.|||NRAS mutations|Participants||Number
1261688|NCT00422448|Primary|Frequency of BRAF Mutations Among Nevi|All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.|up to 30 months|All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.|||BRAF mutations|Participants||Number
1261689|NCT00422422|Secondary|Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period||Baseline to the end of the 3-week evaluation period|Although 99 subjects were in the Safety Set and confirmed to have taken at least one dose of BRV, details on study drug intake were not able to be collected for 2 subjects. Therefore compliance could only be calculated for 97 subjects.|||participants|||Number
1261690|NCT00422422|Secondary|Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period||Baseline to end of the 3-week evaluation period||||participants|||Number
1261699|NCT00422383|Secondary|Percentage of Participants With a Change From BL by Category in Anti-Nuclear Antibodies (ANA) Titers|ANA titers were obtained by the following serum dilution schema: negative = negative, borderline = 1 diluted to (:) 40 or 1:80, and positive ≥ 1:160. The change categories were defined for the change from BL to Weeks 24 and 48 according to this schema. Negative to borderline was defined as any change from negative to borderline as no dilution is given for negative results. Negative to positive was defined as at least a two-fold positive change in dilution from BL. Borderline to negative was defined as any change from borderline to negative as no dilution is given for negative results. Borderline to positive was defined as at least a two-fold positive change in dilution from BL. Positive to borderline was defined as at least a two-fold negative change in dilution from BL. Positive to negative was defined as at least a two-fold negative change in dilution from BL. Unchanged was defined as any difference in dilution less than two-fold.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1261700|NCT00422383|Secondary|Percentage of Participants With Positive Human Anti-Chimeric Antibody (HACA) Titers|A participant was defined as being HACA positive if the HACA serum level was ≥ 5 relative units (RU) per mL and the physician comment read that participant was “immunodepletable with rituximab”.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1261701|NCT00422383|Secondary|Change From BL in Activated Complement Component 4a (C4a) Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||g/L||Standard Deviation|Mean
1261702|NCT00422383|Secondary|Change From BL in Complement C4 Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||g/L||Standard Deviation|Mean
1261703|NCT00422383|Secondary|Percentage of Participants With Complement Component 4 (C4) Protein Level ≤ LLN|The LLN of C4 protein was defined as < 0.1 g/L.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||percentage of participants|||Number
1261704|NCT00422383|Secondary|Change From BL in Activated Complement Component 3a (C3a) Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||g/L||Standard Deviation|Mean
1261705|NCT00422383|Secondary|Change From BL in Complement C3 Protein Level in g/L|The LLN of C3 protein was defined as <0.9 g/L.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||g/L||Standard Deviation|Mean
1261706|NCT00422383|Secondary|Percentage of Participants With Complement Component 3 (C3) Protein Level ≤ LLN|The LLN for C3 protein was defined as <0.9 grams per liter (g/L).|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||percentage of participants|||Number
1261707|NCT00422383|Secondary|Change From BL in Anti-CCP Antibody Titers in U/mL||Weeks 8, 24, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||U/mL||Standard Deviation|Mean
1261708|NCT00422383|Secondary|Anti-Cyclic Citrullinated Peptide (CCP) Antibody Titers at BL in Units Per mL (U/mL)||BL|SAP. 3, 3, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, and High Dose, groups, respectively.|||U/mL||Standard Deviation|Mean
1261709|NCT00422383|Secondary|Percentage of Participants Who Were Rheumatoid Factor (RF) - Seronegative|Percentage of participants who were RF seropositive at BL who became RF seronegative over the course of the study. RF seropositive status was defined as RF ≥ 20 international units (IU) per mL. RF seronegative status was defined as RF < 20 IU/mL.|BL, Weeks 8, 24, and 48|RF seropositive participants from the ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1261710|NCT00422383|Secondary|Percentage of Participants With Total Immunoglobin (Ig), IgA, IgG, and IgM Results Below the LLN|The LLNs for total Ig, IgA, IgG, and IgM were defined as 6.75 grams per liter (g/L), 0.70 g/L, 65 g/L, and 0.40 g/L, respectively.|BL, Weeks 24 and 48|ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1261711|NCT00422383|Secondary|Change From BL in Peripheral CD16+56+ Cell Count|Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261712|NCT00422383|Secondary|Peripheral CD16+56+ Natural Killer (NK) Cell Count in Cells/µL|Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261713|NCT00422383|Secondary|Change From BL in Peripheral CD8+ Cell Count|Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261714|NCT00422383|Secondary|Peripheral CD8+ T Cell Count in Cells/µL|Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261715|NCT00422383|Secondary|Change From BL in Peripheral CD4+ T Cell Count|Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261716|NCT00422383|Secondary|Peripheral CD4+ T Cell Count in Cells/µL|Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261722|NCT00422383|Secondary|Peripheral CD20+ B Cell Count in Cells/µL|Surface expression of CD20 was assessed by FACS analysis as a marker of mature and memory B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|The safety analysis population (SAP) = ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
1261723|NCT00422383|Secondary|Percentage of Participants With Peripheral CD19+ B Cell Counts Above BL or the Lower Limit of Normal (LLN)|Surface expression of CD19 was assessed by FACS analysis as a marker of absolute B lymphocyte count. The LLN was defined as < 80 cells/µL.|BL, Days 1 and 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1261724|NCT00422383|Secondary|Peripheral Cluster of Differentiation (CD) 19 Positive (+) B Cell Count at BL in Cells Per Microliter (Cells/µL)|Surface expression of CD19 was assessed by fluorescence-activated cell sorting (FACS) analysis as a marker of absolute B lymphocyte count.|BL|ITT-M2 population. 7, 8, 3, 1, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, High Dose, Placebo, and Decreased Dose groups, respectively.|||cells/µL||Standard Deviation|Mean
1261725|NCT00422383|Secondary|Terminal Elimination Half-Life (t1/2) in the 1st and 2nd Courses of Treatment in Days|t1/2 values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.|||days||Standard Deviation|Mean
1261726|NCT00422383|Secondary|Maximum Observed Serum Concentrations Following the 2nd Infusion of Rituximab (Csecond) in the 1st and 2nd Courses of Treatment in µg/mL|Csecond values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.|||µg/mL||Standard Deviation|Mean
1261727|NCT00422383|Secondary|Maximum Observed Serum Concentrations Following the 1st Infusion of Rituximab (Cfirst) in the 1st and 2nd Courses of Treatment in Micrograms Per mL (µg/mL)|Cfirst values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.|||µg/mL||Standard Deviation|Mean
1261728|NCT00422383|Secondary|Change in SF-36 Score From BL|SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.|BL, Weeks 24 and 48|ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.|||score on a scale||Standard Deviation|Mean
1261729|NCT00422383|Secondary|Short-Form 36 Health Survey (SF-36) Score|SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.|BL, Week (Wk) 24 and 48|ITT-M2 population, n (number) = number of participants analyzed for the given parameter at the specified timepoint.|||score on a scale||Standard Deviation|Mean
1261730|NCT00422383|Secondary|Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score From BL at Week 48|"FACIT-F scores were obtained from a 13 question self-administered participant questionnaire designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants responded to the questions using a value between 0 and 4, where 0 indicated not at all and 4 indicated very much. 11 of the 13 questions were negatively stated; indicating the higher the score of the participant's response, the greater their fatigue. These questions were calculated as 4 minus the participants' response, so that a higher score indicated an improvement in health. The scores for the 2 positively stated questions were not changed. The participants' responses were summed to result in an overall score, which are scored 0 to 52 (52 = highest level of functioning). A positive change from BL indicated improvement."|BL, Week 48|ITT-M2 population. 9, 4, 2, and 1 participants were not evaluated for this outcome measure from the Low Dose, Escalated Dose, High Dose, and Decreased Dose groups, respectively.|||score on a scale||Standard Deviation|Mean
1261731|NCT00422383|Secondary|Percentage of Participants With a Response at Week 48 by European League Against Rheumatism (EULAR) Category|EULAR responses were categorized according to DAS28-ESR score. DAS28-ESR ≤ 3.2 at Week 48 and a change from BL to Week 48 < -1.2 = good response, DAS28-ESR ≤ 3.2 or greater than (>) 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 < -0.6 and ≥ -1.2 = moderate response, DAS28-ESR > 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 < -1.2 = moderate response, DAS28-ESR > 5.1 at Week 48 and a change from BL to Week 48 < -1.2 = moderate response, DAS28-ESR ≤ 3.2 or > 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 ≥ -0.6 = no response, DAS28-ESR > 5.1 at Week 48 and a change from BL to Week 48 < -0.6 and ≥ -1.2 or ≥ -0.6 = no response.|Week 48|ITT-M2 population|||percentage of participants|||Number
1261764|NCT00422162|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Each Visit|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261732|NCT00422383|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR): Adjusted Mean Change From BL at Week 48|DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * participant's global assessment of disease activity (GH)]. DAS28-ESR ≥ 5.1 = high disease activity, DAS28-ESR less than or equal to (≤) 3.2 = low disease activity, DAS28-ESR less than (<) 2.6 = remission.|BL, Week 48|ITT-M2 population. Two participants from the Low Dose group and 1 participant from the Escalated Dose group were not evaluated for this outcome measure.|||score on a scale||95% Confidence Interval|Mean
1261733|NCT00422383|Secondary|Percentage of Participants With a ACR 70% Improvement Criteria (ACR70) Response at Week 48|ACR70 was defined as an overall score of 70 in the ACRn calculation. The Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR70 set to Non-Responder if ACRn missing.|Week 48|ITT-M2 population|||percentage of participants|||Number
1261734|NCT00422383|Secondary|Percentage of Participants With ACR 50% Improvement Criteria (ACR50) Response at Week 48|ACR50 was defined as an overall score of 50 in the ACRn calculation. Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR50 set to Non-Responder if ACRn missing.|Week 48|ITT-M2 population|||percentage of participants|||Number
1261735|NCT00422383|Primary|Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20)|ACR20 defined as overall score of ≥20 in ACR number (ACRn) calculation. Overall score defined as lowest percent improvement from baseline (BL) of following 3 measures: tender joint count (TJC; 68 joints), swollen joint count (SJC: 66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (visual analog assessment [VAS]), Health Assessment Questionnaire (HAQ), and C-Reactive Protein (CRP). If CRP missing, erythrocyte sedimentation rate (ESR) was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. Last observation carried forward (LOCF) for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR20 set to Non-Responder if ACRn missing|Week 48|ITT-M2 population|||percentage of participants||95% Confidence Interval|Number
1261736|NCT00422292|Other Pre-specified|Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age||Days 0 to 7 after vaccination|Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population.|||Percentage of Participants|||Number
1261737|NCT00422292|Other Pre-specified|Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age|"Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.~Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability."|Days 0 to 7 after vaccination||||Percentage of Participants|||Number
1261738|NCT00422292|Other Pre-specified|Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4||Day 30 after 12-month vaccination||||Percentage of Participants|||Number
1261739|NCT00422292|Primary|Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4||Day 30 after the 12-month vaccination|Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4.|||Titers||95% Confidence Interval|Geometric Mean
1261740|NCT00422292|Primary|Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)|Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.|Day 30 after the 12-month vaccination|Antibody responses were evaluated in the per-protocol population.|||Percentage of Participants|||Number
1261741|NCT00422279|Primary|Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading|The following success criteria for the primary endpoint have been adopted and apply to both treatment groups. 1.The implant stability (ISQ) was recorded by means of resonance frequency analysis (RFA) at implant insertion, 3 months and after 6 months of loading 2. radiographic and computed tomography analyses shall not show any signs of peri-implant radiolucency at the 3 and 6 month time point 3. implant stability after 3 months shall allow tightening to 35Ncm without implant rotation by using a torque wrench|Implant insertion, 3 months, 6 months|Implant stability was measured using a torque wrench, Resonance frequency analysis was conducted, radiographs were analyzed and computed tomography was performed|||implants|Participants||Number
1261804|NCT00422058|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 20|Calculated as mean fasting plasma glucose at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product|||mmol/L||Standard Deviation|Mean
1261742|NCT00422279|Secondary|Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)|"The secondary endpoint of the study was to assess the minimum dose of rhBMP2 eliciting bone growth.The secondary endpoint was assessed by measuring using a probe the quantity of any newly formed bone 1.in the group where implants were placed in the supra alveolar position the treatment is successful if the bone exceeds 1.5 mm above the initial alveolar bone level in all measured points 1. in the group where implants were placed in extraction sockets the treatment is successful if the gap between the implant body and the extraction socket is filled with Bone.~Safety dose used:- In the dog model; seroma formation was extensive with higher rhBMP-2 concentrations (3.0 and 4.0 mg/mL.Seromas was also significant in the dog model for the 0.75 and 1.5 mg/mL rhBMP-2 concentrations, hence a minimum dose of 15 and 30 µg per implants was chosen)"|3 months|1.When implants were placed in the supraalveolar position the treatment was not successful 2. in the group where implants were placed in extraction sockets the treatment was not successful|||Number of participants with bone grow|||Number
1261743|NCT00422227|Secondary|Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales|VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, “in general how would you rate your heath over the last 2-3 weeks”, 0mm equals very well and 100mm equals extremely bad. Pain VAS: “indicate the amount of pain experienced during the last 2-3 days”, 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: “how fatigued or tired have you been over the last week”, range =No Fatigue - Extremely Fatigued.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
1261744|NCT00422227|Secondary|Percent Change From Baseline in Duration (Minutes) of Morning Stiffness|The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
1261745|NCT00422227|Secondary|Percent Change From Baseline in Physician And Subject Global Assessments|The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
1261746|NCT00422227|Secondary|Percent Change From Baseline in Painful and Swollen Joint Counts|Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
1261747|NCT00422227|Secondary|Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percentage of Participants|||Number
1261748|NCT00422227|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response|EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percentage of Participants|||Number
1261749|NCT00422227|Secondary|Percent Change From Baseline in DAS28 at Week 16|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
1261750|NCT00422227|Secondary|Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percentage of Participants|||Number
1261751|NCT00422227|Secondary|Percentage of Participants Achieving ACR 20, 50, and 70 Responses|Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability.|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percentage of Participants|||Number
1261752|NCT00422227|Primary|Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks|"ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening.~The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks."|16 weeks|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Units on a scale||Standard Error|Mean
1261753|NCT00422201|Secondary|Features of Cushing's Syndrome||8 weeks at steady dose|||||||
1261754|NCT00422201|Primary|Glycemic Disorders Improved or Normalized|"Criteria for improvement or normalization of glycemic disorders:~A. For diabetic patients (known or diagnosed at pre-inclusion visit)~Decrease in HbA1c > 0.3% B. For patients with IGT~Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL) D. For patients with IFG~If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion:~- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL)~If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0):~- Normalization of fasting plasma glucose (fasting plasma glucose < 5.5 mmol/L (100 mg/dL)"|8 weeks at steady dose|18 patients were recruited. 7 completed the study but only 3 according to the last protocol version (in which primary efficacy criteria were changed), so only these 3 patients were to be analysed|||participants|||Number
1261755|NCT00422162|Secondary|Change From Baseline to Week 4 and Week 8 in Weight|Change in weight = Post-baseline visit minus baseline.|Baseline to Weeks 4 and 8|All randomized participants with at least one dose of study drug and a baseline and at least one post-baseline value. Last observation carried forward.|||kilograms||Standard Deviation|Mean
1261756|NCT00422162|Secondary|Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study|Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline.|over 8 weeks|All randomized participants with at least one dose of study drug.|||participants|||Number
1261757|NCT00422162|Secondary|Discontinuations Due to Adverse Events (AE)|Listing of adverse events (AE) that led to treatment discontinuation (DC).|over 8 weeks|All randomized participants with at least one dose of study drug.|||participants|||Number
1261758|NCT00422162|Secondary|Number of Patients With Potentially Clinically Significant Laboratory Findings|Laboratory results that were potentially clinically significant.|over 8 weeks|All randomized participants with at least one dose of study drug.|||participants|||Number
1261759|NCT00422162|Secondary|Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication|Number of participants using medication for anxiety and sleep disturbances.|over 8 weeks|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. The total number of patients with hypnotics and anxiolytics concomitant therapies was 125 (Duloxetine 60mg) and 123 (Duloxetine 120mg).|||participants|||Number
1261760|NCT00422162|Secondary|Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8|"The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is not at all important and 6 is extremely important. The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6."|Baseline and Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||units on a scale||Standard Deviation|Mean
1261761|NCT00422162|Secondary|Patients Reaching Remission|Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.|Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||participants|||Number
1261762|NCT00422162|Secondary|Percentage of Responders|Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS <50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks.|4 to 8 weeks|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||percentage of participants|||Number
1261763|NCT00422162|Secondary|Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8|The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline and Weeks 4 and 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261765|NCT00422162|Secondary|Clinical Global Impression of Improvement (CGI-I) at Each Visit|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261766|NCT00422162|Secondary|Clinical Global Impression of Severity (CGI-S) Scores at Each Visit|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261767|NCT00422162|Secondary|Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)|"Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe)."|4 to 8 weeks|All randomized participants who received at least one dose of study drug and had a Week 4 and at least one following value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||units on a scale||Standard Deviation|Mean
1261768|NCT00422162|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||units on a scale||Standard Deviation|Mean
1261769|NCT00422162|Secondary|Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline|"The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe)."|Baseline to Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||units on a scale||Standard Deviation|Mean
1261770|NCT00422162|Primary|Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 4|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1261771|NCT00422097|Secondary|Number of Participants With Abnormal (CTC Grade 3 or Greater) Serum Chemistry Levels|Upper limit of normal (ULN)=upper level of normal among all laboratory ranges. Alkaline phosphatase(U/L): Gr 3: >5.0-20.0*ULN; Gr 4: >20.0*ULN. Sodium (mEq/L): Gr 3: 120-<130 or >155-160; Gr 4 <120. Potassium (mEq/L): Gr 3: 2.5-<3.0 or >6.0-7.0; Gr 4: <2.5 or >7.0. Calcium (mg/dL): Gr 3: 6.0-<7.0 or >12.5-13.5; Gr 4: <6.0 or >13.5. Inorganic phosphorus (mg/dL): Gr 3: 1.0-<2.0; Gr 4: <1.0. Albumin (g/dL): Gr 3: <2.0.|At screening and predose Day 1, Cycle 1 (21 days)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.|||Participants|||Number
1261772|NCT00422097|Secondary|Number of Participants With Significant Findings on Physical Examination or Electrocardiogram (ECG)|Physical examination evaluated height, weight, Eastern Cooperative Oncology Group performance status, adverse events, and abnormal laboratory findings and included a neurologic examination to evaluate deep tendon reflexes, sensory modalities, and motor strength. Participants also underwent a 12-lead ECG screening. Physical examination findings and ECG findings were considered clinically significant at the investigator's discretion.|At screening and predose Day 1, Cycle 1 (21 days)|Although physical examinations and ECGs were performed, the findings were not summarized.|||Participants|||Number
1261773|NCT00422097|Secondary|Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given alone once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.|||ng*h/mL||Standard Deviation|Mean
1261774|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.|||ng/mL||Full Range|Median
1286683|NCT00168831|Secondary|Change From Baseline in Neutrophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1261775|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.|||ng/mL||Standard Deviation|Mean
1261776|NCT00422097|Secondary|Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).|||ng*h/mL||Standard Deviation|Mean
1261777|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax)of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).|||ng/mL||Full Range|Median
1261778|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the MTD has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine (Cycle 2).|||ng/mL||Standard Deviation|Mean
1261779|NCT00422097|Secondary|Plasma Half-life (T-Half) of Ixabepilone||Day 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles|||Hours||Standard Deviation|Mean
1261780|NCT00422097|Secondary|Area Under the Concentration-time Curve in 1 Dosing Interval (AUC[TAU])of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles.|||ng*h/mL||Standard Deviation|Mean
1261781|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax) of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles|||Hour||Full Range|Median
1261782|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles|||ng/mL||Standard Deviation|Mean
1261783|NCT00422097|Primary|Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade|Adverse events (AEs) graded by CTC version 3. Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=life threatening; Gr 5=Death related to AE. DLT is defined as an event related to ixabepilone that occurs during the first course of treatment. Includes neutropenia; thrombocytopenia; Gr 3 or 4 nausea, vomiting, or diarrhea despite adequate medical intervention and prophylaxis; Gr 3 fatigue or asthenia; transient arthralgia or myalgia unresponsive to medical intervention; any Gr 3 nonhematologic toxicity; and prolonged recovery from a toxicity.|Days 1 through 21 (Cycle 1), continuously|All Treated Participants: All participants who received at least one dose of ixabepilone were included.|||Participants|||Number
1261784|NCT00422097|Secondary|Number of Participants With Abnormal Laboratory Values by Worst CTC Grade|Lower limit of normal (LLN)=lowest level of normal among all laboratory ranges. Hemoglobin (g/dL): Gr 1: 10.0-<LLN; Gr 2: 8.0-<10.0; Gr 3:6.5-<8.0; Gr 4: 6.5. Leukocytes (c/uL): Gr 1: 3.0-<LLN; Gr 2: 2.0-<3.0; Gr 3: 1.0-<2.0; Gr 4: <1.0. Lymphocytes (c/uL): Gr 1: 0.8-<1.5; Gr 2: 0.5-<0.8; Gr 3: 0.2-<0.5; Gr 4: <0.2. Neutrophils (Absolute)(c/uL): Gr 1: 1.5-<2.0; Gr 2: 1.0-<1.5; Gr 3: 0.5-<1.0; Gr 4: <0.5. Neutrophils + Bands (c/uL): Gr 1: 1.5-<2.0; Gr 2: 1.0-<1.5; Gr 3: 0.5-<1.0; Gr 4: <0.5. Platelet Count (c/uL):Gr 1: 75.0-<LLN; Gr 2: 50.0-<75.0; Gr 3: 25.0-<50.0; Gr 4: <25.0.|Baseline and Days 1, 8, and 15 of Cycle 1 (21 days)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.|||Participants|||Number
1261785|NCT00422097|Primary|Maximum Tolerated Dose (MTD) of Ixabepilone|MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level. DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged recovery from a toxicity, that occurs during the first course of treatment.|Days 1 through 21 (Cycle 1)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.|||mg/d|||Number
1261822|NCT00421889|Primary|Dose Limiting Toxicities (DLT), Part A|To determine the number of participants experiencing dose limiting toxicities of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin and paclitaxel or both.|Cycle 1||||participants|||Number
1261786|NCT00422097|Secondary|Number of Participants With Death as Outcome, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21 (Cycle 1), continuously|All Treated Subjects: All subjects who received at least 1 dose of ixabepilone.|||Participants|||Number
1261787|NCT00422058|Secondary|Change From Baseline in Blood Pressure at Week 104|Calculated as mean blood pressure at week 104-baseline.|Week 0, week 104|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product|||mmHg||Standard Deviation|Mean
1261788|NCT00422058|Secondary|Change From Baseline in Blood Pressure at Week 20|Calculated as mean blood pressure at week 20-baseline.|Week 0, week 20|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product|||mmHg||Standard Deviation|Mean
1261789|NCT00422058|Secondary|Change From Baseline in Waist Circumference at Week 104|Calculated as mean waist circumference at week 104-baseline.|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||cm||Standard Deviation|Mean
1261790|NCT00422058|Secondary|Change From Baseline in Waist Circumference at Week 20|Calculated as mean waist circumference at week 20-baseline.|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||cm||Standard Deviation|Mean
1261791|NCT00422058|Secondary|Change From Baseline in Adiponectin at Week 104|Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||mcg/mL||Standard Deviation|Mean
1261792|NCT00422058|Secondary|Change From Baseline in Adiponectin at Week 20|Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||mcg/mL||Standard Deviation|Mean
1261793|NCT00422058|Secondary|Change From Baseline in Fibrinogen at Week 104|Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||g/L||Standard Deviation|Mean
1261794|NCT00422058|Secondary|Change From Baseline in Fibrinogen at Week 20|Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||g/L||Standard Deviation|Mean
1261795|NCT00422058|Secondary|Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104|Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||U/mL||Standard Deviation|Mean
1261796|NCT00422058|Secondary|Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20|Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||U/mL||Standard Deviation|Mean
1261797|NCT00422058|Secondary|Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104|Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||mg/L||Standard Deviation|Mean
1261798|NCT00422058|Secondary|Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20|Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||mg/L||Standard Deviation|Mean
1261799|NCT00422058|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104|Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||percentage (%) of total haemoglobin||Standard Deviation|Mean
1261800|NCT00422058|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20|Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||percentage (%) of total haemoglobin||Standard Deviation|Mean
1261801|NCT00422058|Secondary|Change From Baseline in Fasting Insulin at Week 104|Calculated as mean fasting insulin at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||pmol/L||Standard Deviation|Mean
1261802|NCT00422058|Secondary|Change From Baseline in Fasting Insulin at Week 20|Calculated as mean fasting insulin at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||pmol/L||Standard Deviation|Mean
1261803|NCT00422058|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 104|Calculated as mean fasting plasma glucose at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product|||mmol/L||Standard Deviation|Mean
1263059|NCT00412360|Secondary|Percentage of Participants With Treatment-related Mortality|Treatment related mortality is defined as death without relapse of the primary disease.|1 year post-randomization|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
1261805|NCT00422058|Secondary|Mean Change From Baseline in Body Weight at Week 104|Calculated as mean body weight at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.|||kg||Standard Deviation|Mean
1261806|NCT00422058|Primary|Mean Change From Baseline in Body Weight at Week 20|Calculated as mean body weight at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.|||kg||Standard Deviation|Mean
1261807|NCT00422032|Primary|Number of Participants With Response for Two Dose Schedules of Clofarabine|Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils >/= 1 * 10^9/L and platelet counts >/= 100 * 10^9/L, and marrow blasts </=5%; Partial Remission: as above except for presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment; or Hematologic Improvement (HI): Complete Response (CR) with the exception of a lack of platelet recovery to >/= 100 * 10^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).|4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)||||Participants|||Number
1261808|NCT00421993|Secondary|Percent Change in Total Lesion Counts|Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF|||Percent change||Standard Deviation|Mean
1261809|NCT00421993|Secondary|Percent Change in Noniflammatory Lesion Counts|Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF|||Percent change||Standard Deviation|Mean
1261810|NCT00421993|Secondary|Percent Change in Inflammatory Lesion Counts|Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF|||Percent change||Standard Deviation|Mean
1261811|NCT00421993|Primary|Changes in Noninflammatory Lesion Counts|Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count|from Baseline to week 12|ITT, LOCF|||Lesion count||Full Range|Median
1261812|NCT00421993|Primary|Changes in Inflammatory Lesion Counts|Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts|from Baseline to week 12|ITT, LOCF|||Lesion count||Full Range|Median
1261813|NCT00421993|Primary|Success Rate on the Investigator's Global Assessment|Percentage of subjects rated “Clear” and “Almost Clear” on 5-point scale (0=clear; 4=severe)|at week 12|Intention to treat (ITT), last observation carried forward (LOCF).|||Percentage of participants|||Number
1261814|NCT00421954|Primary|Weight Gain and Other Side Effects||couple of months|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1261815|NCT00421928|Secondary|Change From Baseline in Responder Analysis 50% Improvement to Week 12|"Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12. For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and Week 12|ITT. Subjects who discontinued from the study were considered non-responders.|||Percentage of participants|||Number
1261816|NCT00421928|Secondary|Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EQ-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead"|Baseline and 12 week endpoint|ITT|||scores on a scale||Standard Deviation|Mean
1261817|NCT00421928|Secondary|Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy|The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint|Baseline to 12 weeks|ITT: The results for median and interquartile ranges were not estimable because insufficient number of subjects discontinued due to lack of efficacy to estimate the values.|||median time|||Number
1261818|NCT00421928|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved)|Baseline and 12 week endpoint|ITT|||percentage of participants|||Number
1261819|NCT00421928|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionniare addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement."|Baseline and 12 week endpoint|ITT|||Hours||Standard Deviation|Mean
1261820|NCT00421928|Secondary|Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12|Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability|Baseline and 12 week endpoint|Intent To Treat (ITT), observed cases analysis conducted, no imputation performed.|||Scores on a scale||Standard Deviation|Mean
1261821|NCT00421928|Primary|Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation|||Scores on a scale||Standard Deviation|Mean
1286684|NCT00168831|Secondary|Change From Baseline in Monocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1261823|NCT00421889|Secondary|Belinostat AUC (0-infinity)||Cycle 1 Day 1: Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 39 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters.|||ng*h/mL||Standard Deviation|Mean
1261824|NCT00421889|Secondary|Belinostat Mean t½||Cycle 1 Day 1: Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 39 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters|||hours||Standard Deviation|Mean
1261825|NCT00421889|Secondary|Belinostat Cmax||Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 41 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
1261826|NCT00421889|Secondary|Duration of Response|Defined as interval from the time criteria for CR or PR are met, until the first date that recurrent or progressive disease is objectively documented.|Throughout study|Includes patients with response, i.e. 15 patients in Part B, 0 patients in Part C, and 4 patients in Part D. Not done for Part A.|||days||Full Range|Median
1261827|NCT00421889|Secondary|Time to Response|Time to response (RECIST) was assessed as the interval between the first dates of treatment until the first notation of response.|Throughout study|Includes patients with response, i.e. 15 patients in Part B, 0 patients in Part C, and 4 patients in Part D. Not done for Part A.|||days||Full Range|Median
1261828|NCT00421889|Secondary|Time to Progression|Time to progression, defined as the interval between the first dates of treatment until the first notation of disease progression. RECIST criteria|Throughout study|Per protocol Population, includes all patients who have received at least two cycles (complete treatment days, dose reductions per protocol allowed) of study treatment and who have also had at least one post-baseline tumor assessment. Not done for Part A.|||days||95% Confidence Interval|Median
1261829|NCT00421889|Secondary|To Determine the Pharmacodynamic Effects of Belinostat (in the Combination) on Histone Acetylation in Peripheral Blood Mononuclear Cells (Selected Sites)||Throughout the study|Histone acetylase analysis was planned, but not successful due to technical issues with the method.||||||
1261830|NCT00421889|Secondary|Best Overall Response (CR or PR)|Best overall responses were assessed by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Clinical tumor evaluation will take place after each cycle. Formal radiological evaluation after every 2 cycles. If a response is noted, a follow-up radiographic assessment must be performed 4 weeks (+ 1 week) after the response is noted|Throughout study until PD (progressive disease) or lost to follow up|Primary efficacy analysis population, includes all patients who have been enrolled into the study and received at least one dose of study medication.|||participants|||Number
1261831|NCT00421889|Primary|Maximum Tolerable Dose (MTD) Belinostat, Part A,|To determine the maximum tolerated dose of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin (AUC of 5) and paclitaxel (175 mg/m2).|Cycle 1||||mg/m2|||Number
1261832|NCT00421733|Secondary|Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.|Change is mean change in picograms of iPTH per milliliter of serum.|Baseline (screening period) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline and a last on-treatment measurement were excluded from the analyses.|||picogram/milliliter||Standard Deviation|Mean
1261833|NCT00421733|Secondary|Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.|The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.|||log milligrams of albumin per 24 hours||Standard Deviation|Mean
1261834|NCT00421733|Secondary|Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.|Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.|||Participants|||Number
1261835|NCT00421733|Primary|Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).|UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized participants who received at least 1 dose of study drug. Subjects without both a baseline and last on-treatment measurement were excluded from the primary efficacy analysis. As such, sample size was N=88 for placebo, N=92 for 1 mcg and for 2 mcg paricalcitol, and N=184 for combined paricalcitol.|||log milligram/gram creatinine||Standard Deviation|Mean
1261876|NCT00420927|Secondary|Change From Baseline in SDAI Score at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Baseline to Week 78||||Scores on a scale||Standard Deviation|Mean
1261836|NCT00421707|Secondary|Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD)|HAD Scale was used to assess the severity of symptoms of anxiety and depression in participants. There were 14 questions. Seven questions related to depression and seven questions related to anxiety. Participants rated the severity of symptoms in the answer to each question. There were four options in each answer, from which participants had to select one. Responses were scored on a scale of 0, 1, 2 or 3, where 0 indicated best and 3 indicated worse. Total score ranged from 0-42 where 0 indicated absence of symptoms and higher scores indicated higher anxiety/depression complains. This questionnaire was completed at screening, and all study visits.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed. Washout period was of 3 weeks only. Thus, these categories are not applicable for placebo washout arm.|||Score on a scale||Standard Deviation|Mean
1261837|NCT00421707|Secondary|Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment|The PHQ-15 comprised of 15 somatic symptoms from the PHQ, each symptom scored from 0 to 2, where 0 (“Not bothered at all”), 1 (Bothered a little) 2 (“bothered a lot”). This questionnaire was completed at screening, and all study visits. Total score range was 0-30, where 0 indicated Not bothered at all and 30 indicated “bothered a lot”. Higher score indicated greater severity of somatization symptoms.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1261838|NCT00421707|Secondary|IBS Composite Symptom Score|Investigation of possible composite symptom score was planned. The data was not collected for composite symptom score.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|||||||
1261839|NCT00421707|Secondary|Plasma Concentrations of GW876008 at Week 3 and 6|For Week 3, 6, 9, 12, and 15 visits blood samples were collected at: pre-dose (after the pre ECG measurement and just before am dose) and immediately following the 1-3 hour post-dose ECG measurement and concentration of GW876008 was analyzed. Data for Week 3 and 6 was presented.|Week 3 and 6 visits. Pre-dose [after the pre Electrocardiogram (ECG) measurement and just before am dose] and immediately following the 1-3 hour post-dose ECG measurement|Pharmacokinetic concentration population comprised of all participants for whom a pharmacokinetic sample was obtained and analyzed was included. Only those participants available at the specified time points were analyzed.|||ng/mL||Standard Deviation|Mean
1261840|NCT00421707|Secondary|Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function|"The GIS comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse. Number of participants who showed improvement and changes on the scale were presented. Participants were counted as Yes if they scored 1-3, and as No if they scored 4-7."|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population.|||Participants|||Count of Participants
1261841|NCT00421707|Secondary|Percentages of Pain-free Days|Abdominal pain free days are those days where the participant reported a score of '0' for abdominal pain at its worst. Abdominal Pain (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed. Washout period was of 3 weeks only. Thus, these categories are not applicable for placebo washout arm.|||Percentage of days||Standard Deviation|Mean
1261842|NCT00421707|Secondary|Change From Baseline in Pain Severity Scores|Pain severity scores from the 11-point scale and it's corresponding change from Baseline scores was summarized by treatment group for the last 4 weeks (i.e. weeks 3-6 and Weeks 12-15) of treatment period. Scale from 0 to 10, 0 meaning no pain, 10 worst possible pain. Lower values represent a better outcome. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting baseline value from specified time point value. Reported data values are lesser than minimum score on scale as change from Baseline is reported.|Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1261843|NCT00421707|Secondary|Number of Participants With Improvements in Pain and Discomfort|Number of participants with improvements in pain and discomfort on GIS were presented. GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse on specified time points. Responder = Yes if A responder answered either 'moderately improved' or 'substantially improved'.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1261844|NCT00421707|Primary|Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale|The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1261877|NCT00420927|Secondary|Change From Baseline in CDAI Score at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Baseline to Week 78||||Scores on a scale||Standard Deviation|Mean
1286816|NCT00167414|Secondary|Number of Participants Who Experienced a Grade 4 or 5 Toxicity|Number of participants who experienced a grade 4 or 5 toxicity|6 years||||Participants|||Count of Participants
1261845|NCT00421707|Primary|Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen|The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Proportion of participants responded||Standard Deviation|Mean
1261846|NCT00421707|Primary|Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2|For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.|Up to Day 105|Intent to Treat population||||||
1261847|NCT00421707|Primary|Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2).|For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.|Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2).|Intent to Treat population.||||||
1261848|NCT00421707|Primary|Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2).|For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question ‘In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.|Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2)|Intent to Treat population comprised of all participants who were randomized to treatment, who received at least one dose of double blind medication and for whom at least one valid post baseline efficacy assessment was available.||||||
1261849|NCT00421603|Primary|Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back|Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period by the Time Line Follow Back. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.|3 weeks of abstinence during 14 weeks of trial or for length of participation||||participants|||Number
1261850|NCT00421408|Primary|Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at 18 months|All participants were analyzed using the mixed models method. For the Quantitative Computed Tomography (QCT) test only half of the participants were randomized to receive it.|||mg/cm^3||Standard Error|Least Squares Mean
1261851|NCT00421408|Primary|Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at 0 months|All participants were analyzed using the mixed models method. For the Quantitative Computed Tomography (QCT) test only half of the participants were randomized to receive it.|||mg/cm^3||Standard Error|Least Squares Mean
1261852|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 18 months|All participants were analyzed using the mixed models method.|||g/cm^2||Standard Error|Least Squares Mean
1261853|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 9 months|All participants were analyzed using the mixed models method.|||g/cm^2||Standard Error|Least Squares Mean
1261854|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 0 months|All participants were analyzed using the mixed models method.|||g/cm^2||Standard Error|Least Squares Mean
1261855|NCT00421408|Primary|Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at baseline and 18 months|Only participants with data at the baseline and 18 month timeframe were used in the analysis. Only half of the study partipants were randomized to receive Quantitative Computed Tomography testing.|||percent change||Standard Error|Mean
1261856|NCT00421408|Primary|Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at baseline and 18 months|Only participants with data at the baseline and 18 month timeframe were used in the analysis.|||percentage change||Standard Error|Mean
1261857|NCT00421343|Secondary|Reasons for Non-willingness to Particiapte and Non-adherence With Intervention|We asked participants who would not participate the primary reason for non-particiaption. We also asked participants who were not adherent with recommendations what the primary reason ws for non-adherence.|6 months|||||||
1261858|NCT00421343|Primary|Number Adherent With the Intervention||6 months||||participants|||Number
1261859|NCT00421174|Secondary|Pro-inflammatory Markers of Pulmonary Disease, in Both BAL Fluid and Plasma||Day 28|No data collected||||||
1261860|NCT00421174|Secondary|Dermatologic Reaction||Day 28|No data collected||||||
1261861|NCT00421174|Secondary|Overall Mortality||Year 2||||participants|||Number
1261862|NCT00421174|Secondary|Incidence of Relapse|Percentage of patients who experience relapse. Deaths without relapse are considered as a competing risk.|Year 1||||Participants|||Count of Participants
1261863|NCT00421174|Secondary|Incidence of Graft-vs-Host-Disease (GVHD)||Year 1||||percentage of participants||95% Confidence Interval|Number
1261864|NCT00421174|Secondary|Incidence of Toxicity||Day 56||||Toxcities|Total number of toxicities||Number
1261865|NCT00421174|Secondary|Incidence of Infection||Day 56||||Infections|Total number of infections||Number
1261866|NCT00421174|Secondary|Overall Survival|Percentage of patients that survived after one year|Year 1||||percentage of participants||95% Confidence Interval|Number
1261867|NCT00421174|Secondary|Corticosteroid Dose|Patients were treated with systemic corticosteroids with methylprednisolone at 2 mg/kg/day on day 0, with taper allowed after day 7.|Day 14 and 28||||mg/kg/day||Full Range|Median
1261868|NCT00421174|Secondary|Discontinuation of Supplemental Oxygen|The “time required to discontinue supplemental oxygen” will be measured in the number of days from study entry.|Day 56||||days||Full Range|Median
1261869|NCT00421174|Secondary|Response to Therapy|Response will be defined as the ability to survive to Day 56 of study, plus the ability to completely discontinue all supplemental oxygen support for > 72 consecutive hours during this time period.|Day 56||||percentage of participants||95% Confidence Interval|Number
1261870|NCT00421174|Primary|Response Rate|Response will be defined as survival to Day 28 of study, plus discontinuation of all supplemental oxygen support for more than 72 consecutive hours by Day 28.|Day 28||||percentage of participants||95% Confidence Interval|Number
1261871|NCT00420992|Primary|Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)|Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.|randomization to 12 weeks following randomization|intent to treat (ITT)|||units on scale||Standard Deviation|Mean
1261872|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.|Week 78||||Participants|||Number
1261873|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.|Week 78||||Participants|||Number
1261874|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78||||Participants|||Number
1261875|NCT00420927|Secondary|Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78|Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.|Baseline to Week 78|The analysis is based on the Primary Analysis Set, a subset of the ITT Analysis Set that includes subjects who participated in the 78-week HF MRI substudy and whose Baseline HF MRI data were collected on or before the first study drug dose. Observed scores are used in the analysis.|||Scores on a scale||Standard Deviation|Mean
1262674|NCT00414453|Secondary|Brief Pain Inventory Interference Items|subject completes the brief pain questionaire|occurs Visit 1, 3,4,5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
1261878|NCT00420927|Secondary|Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Week 78||||Participants|||Number
1261879|NCT00420927|Secondary|Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Week 78||||Participants|||Number
1261880|NCT00420927|Secondary|Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Week 78||||Participants|||Number
1261881|NCT00420927|Secondary|Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Week 78||||Participants|||Number
1261882|NCT00420927|Secondary|Change From Baseline in DAS28 Score at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Baseline to Week 78||||Scores on a scale||Standard Deviation|Mean
1261883|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78|Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
1261884|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78|Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
1261885|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78|Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
1261886|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78|For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
1261887|NCT00420927|Secondary|Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
1261888|NCT00420927|Secondary|Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Week 78|ITT Population, Nonresponder imputation|||Participants|||Number
1261889|NCT00420927|Secondary|Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78||||Participants|||Number
1261890|NCT00420927|Primary|Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78|The analysis was performed on the ITT Population comprised of all subjects who entered Period 2 and received at least 1 dose of study drug (blinded or open-label) during Period 2. Nonresponder imputation was used for missing data.|||Participants|||Number
1261891|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261892|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261893|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261894|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261895|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale|EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261896|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261897|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261898|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261899|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261900|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261901|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261902|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261903|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261904|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261905|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261906|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261907|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261908|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261909|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
1261910|NCT00420849|Secondary|Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)|Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.|up to 124 weeks|Safety population|||weeks||Standard Deviation|Mean
1261911|NCT00420849|Secondary|Participants With Adverse Events of Special Interest: Venous Thromboembolic Events|Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.|up to 124 weeks|Safety population|||participants|||Number
1261912|NCT00420849|Secondary|Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)|Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.|up to 124 weeks|Safety population|||weeks||Standard Deviation|Mean
1261913|NCT00420849|Secondary|Participants With Adverse Events of Special Interest: Peripheral Neuropathy|Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.|up to 124 weeks|Safety population|||participants|||Number
1261914|NCT00420849|Primary|Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment|"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.~National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death."|up to 123 weeks|Safety population|||participants|||Number
1261915|NCT00420784|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Week 2, 4, 8, 12, 16, 24|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1261916|NCT00420784|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).|||participants|||Number
1261917|NCT00420784|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to 2 weeks after last dose of study drug (up to Week 50)|Full Analysis Set = subjects who received at least 1 dose of study drug.|||participants|||Number
1261918|NCT00420784|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA|"Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week and at 48 weeks after last dose of study drug for treatment groups Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL)."|Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)|Full Analysis Set = subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
1261919|NCT00420784|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|Completion of study drug dosing (up to Week 48)|Full Analysis Set = subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
1261920|NCT00420784|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|Full Analysis Set = subjects who received at least 1 dose of study drug|||percentage of participants|||Number
1261921|NCT00420771|Primary|Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back|Comparing the mean reduction change in Benzodiazepine use per day when comparing the baseline week prior to study entry to the last week of study participation based on the Time Line Follow Back|data collected during 8 weeks of trial or length of participation|a total of 16 participants had data available post randomization|||milligrams/day||Standard Deviation|Mean
1261965|NCT00420459|Secondary|The Children's Yale-Brown Obsessive Compulsive Scale|The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome.|Obtained at Baseline and Week 12||||units on a scale||Standard Deviation|Mean
1261922|NCT00420745|Secondary|Serum Anti–Rotavirus IgA Antibody Concentration.|Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals, calculated on all subjects.|At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the According-to-Protocol immunogenicity cohort. The anti-rotavirus IgA antibody GMC for Placebo Group was below the assay cut-off (<20 U/mL), so could not be computed.|||U/mL||95% Confidence Interval|Geometric Mean
1261923|NCT00420745|Secondary|Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.|Number of subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL).|At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the According-to-Protocol immunogenicity cohort that included all subjects with at least one study vaccine or placebo administered, for whom immunogenicity data were collected and available and who complied with the inclusion criteria defined in the protocol.|||subjects|||Number
1261924|NCT00420745|Secondary|Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.|Gastroenteritis (GE): diarrhoea with or without vomiting. Rotavirus (RV) GE: A GE episode was a RV GE if a stool sample taken during or not later than 7 days after the episode was RV positive by Enzyme Linked Immunosorbent Assay.|From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.|||subjects|||Number
1261925|NCT00420745|Secondary|Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.|Solicited symptoms included Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5 degrees Celsius (°C)), Irritability, Loss of appetite, and Vomiting|Within 15 days after each Rotarix vaccine/Placebo dose.|The analyses were performed on the Total vaccinated cohort for the safety and the immunogenicity subset that included all subjects with at least one study vaccine or placebo administered and for whom solicited symptoms were collected.|||subjects|||Number
1261926|NCT00420745|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after any Rotarix vaccine/Placebo dose.|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.|||subjects|||Number
1261927|NCT00420745|Primary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.|||subjects|||Number
1261928|NCT00420641|Secondary|Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10|CSSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behaviour and ideation. For SB scale, participants were scored as “non-suicidal” (00), “preparatory acts or behavior communicating ideation” (01), “aborted attempt” (02), “interrupted attempt” (03) or “actual attempt” (04) based on the most severe score (4 being the most severe). On SI scale, participants were scored as “non-suicidal” (00), “wish to be dead” (01), “non-specific active suicidal thoughts” (02), “active suicidal ideation with associated thoughts of methods without intent” (03), “active suicidal ideation with some intent to act on suicidal thoughts without clear plan” (04), “active suicidal ideation with plan and intent” (05), based on the most severe score (5 being the most severe). For both subscales, 0 indicated absence of symptom and higher score indicated greater severity of symptom. Only those scores for which at least one participant was reported are summarized.|Up to Week 10|ITT Population.|||Participants|||Count of Participants
1261929|NCT00420641|Secondary|Percentage of Participants Satisfied With Study Medication at Week 10|"Participants were asked complete the participant Satisfaction with Study Medication question at Week 10 (or early withdrawal). Satisfaction was measured using a single 7-point Likert scale from 1 to 7 where higher scores indicate greater satisfaction with study medication. A score of 1 represents very dissatisfied, whilst a score of 7 represents very satisfied. Participants were categorized as a responder if they are rated either as 6 Satisfied or 7 Very Satisfied. The proportion of responders as percentage of participants based on the participant satisfaction with study medication item was defined as: number of participants with a response of 6 or 7 at the visit divided by number of participants with a satisfaction with study medication assessment at that visit (the sum of responders and non-responders) multiplied by 100."|Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1261930|NCT00420641|Secondary|Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10|The CGI-I scale measures the improvement of psychiatric symptoms on a 7-point scale from 1-7. The scale was rated by the clinician at every visit during the treatment phase (Week 1 through Week 10/early withdrawal) of the participant's total improvement or worsening compared with that individual's condition at the start of the study (the Randomization visit , Week 0) whether or not the change is judged to be due to drug treatment. The scores indicated the following: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse. The score ranged from 1-7, where 1 indicated very much improved and higher score indicated greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Data is reported for the percentage of participants who were much improved and very much improved.|Up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1261980|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 112 mmHg|||mmHg||Standard Deviation|Mean
1261931|NCT00420641|Secondary|Percentage of Responders and Remitters of HAMD-17 Over Week 10|HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAMD-17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Responders were defined as participants who had a >=50% reduction from randomization in HAMD-17 total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a HAMD-17 total score <=7.|Up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1261932|NCT00420641|Secondary|Percentage of Responders and Remitters of IDS-CR Over Week 10|IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score of IDS-CR calculated as : either item 11 or 12 scored; either item 13 or 14 scored; if both items scored, the highest of the items was used. Total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Responders were defined as participants who had a >=50% reduction from randomization in IDS-CR total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a IDS-CR total score <=14.|Up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1261933|NCT00420641|Secondary|Percentage of Responders and Remitters of MADRS Over Week 10|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The total score ranged from 0-60, where 0 indicated no depression and 60 indicated severely depressed. Responders were defined as participants who had a >=50% reduction from randomization in MADRS total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a MADRS total score <=11.|Up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1261934|NCT00420641|Secondary|Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8|The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. Rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to randomization.|Week 0 (Randomization) up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261935|NCT00420641|Secondary|Mean Change From Randomization in IDS-CR Total Score Over Week 8|The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to Randomization.|Week 0 (Randomization) up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261936|NCT00420641|Secondary|Mean Change From Randomization in the MADRS Total Score Over Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The total score ranged from 0-60, where 0 indicated no depression and 60 indicated severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to Randomization.|Week 0 (Randomization) up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261966|NCT00420459|Primary|Clinical Global Impressions- Severity|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Obtained at Baseline and Week 12||||units on a scale||Standard Deviation|Mean
1261937|NCT00420641|Secondary|Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10|The CSFQ-14SF is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning. It is consisting of 14 items that measure sexual activity and sexual functioning. It measures five dimensions of sexual behavior: pleasure (1 item); desire/frequency (items 2 and 3); desire/interest (items 4, 5 and 6); arousal (items 7, 8 and 9); and orgasm (items 11, 12 and 13). Items 10 and 14 are included in the total score but not in any dimension score. Items were rated on an 5 point scale from 1 to 5. Total score ranged from 14 to 70, where higher scores indicate higher sexual functioning and lower score indicate lower sexual functioning. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the total score was the difference between CSFQ-14SF score at the individual time points being analyzed (Week 4 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261938|NCT00420641|Secondary|Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10|MEI 18 item-SF questionnaire was used to measure reductions in mental energy, physical energy, and social motivation. All items use either a 7-level (0-6) or 5-level (0-4) response scale; for questions 1, 2, and 13-18, response ‘0’ indicates lower motivation, energy and interest and responses with higher scores indicate increased motivation, energy and interest. For questions 3-12, response ‘0’ indicates higher motivation, energy and interest and responses with higher scores indicate lower motivation, energy and interest. Items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored. Total score ranges from 0-108, where 0 indicates lower motivation, energy and interest and higher score indicates higher motivation, energy and interest. Randomization value was defined as assessment value done on Week 0. Change from Randomization in total score was difference between MEI score at individual time points being analyzed (Week 1, 4 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261939|NCT00420641|Secondary|Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10|The CGI-S scale measures the severity of psychiatric symptoms on a 7-point scale from 1-7. The scores indicated the following: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The score ranged from 1-7, where 1 indicated absence of symptoms and higher score indicated greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the score was the difference between CGI-S score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population with OC analysis. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261940|NCT00420641|Secondary|Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10|The IDS-CR and IDS-SR is a standardized 30-item scale rated by the clinician and the participant respectively to assess the severity of a participant's depressive symptoms. The 5 items of the IDS subscale include: item 19 (general interest/involvement), item 20 (energy/fatigability), item 21 (pleasure/enjoyment), item 22 (sexual interest), item 30 (Leaden paralysis/physical energy) which assessed participant’s pleasure, interest and energy. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score ranges from 0 to 15, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS 5 Item subscale total score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261941|NCT00420641|Secondary|Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10|HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAMD-17 are rated on a 3-point scale of 0-2 or a 5-point scale of 0-4. The item 1 (Depressed Mood) of HAMD-17 was rated the 5-point scale of 0-4, where 0 indicates absence of symptom and higher score indicates more severe symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the score was the difference between HAMD-17 Item 1 score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population with OC analysis. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261942|NCT00420641|Secondary|Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score|HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items of HAMD-17 are rated on a scale 3-point scale of 0-2 or a 5-point scale of 0-4 where 0 is absence of symptom and higher score indicate more severe symptom. Items rated on the 3-point scale include: insomnia early, middle, late; somatic symptoms gastrointestinal and general; genital symptoms; loss of weight; insight. Items rated on 5-point scale include: depressed mood; feelings of guilt; suicide; work and activities; retardation; agitation; anxiety psychic and somatic; hypochondriasis. Total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between HAMD-17 total score at the time point being analyzed (Week 10) to Randomization.|Week 0 (Randomization) and Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261981|NCT00420342|Secondary|Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8|Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported.|8 weeks plus 3 days|FAS subjects from the one site which performed the sodium sensitivity analysis|||participants|||Number
1261943|NCT00420641|Secondary|Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10|The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The item 5 (Feeling Sad) of IDS-CR was rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in score was the difference between IDS-CR Item 5 score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261944|NCT00420641|Secondary|Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10|The MADRS scale measures the depression level of a participant. The items of the scale include: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. The item 2 (Reported Sadness) of MADRS was scored using a scale 7-point scale of 0-6, where 0 indicates absence of symptom and higher score indicates increased severity of symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS Item 2 score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261945|NCT00420641|Secondary|Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology–Self-rated Version (QIDS-SR16) Total Score Over Week 10|QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by participant. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score was obtained by adding scores of the items of sad mood, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite or weight, concentration/decision making, suicidal ideation and psychomotor agitation/retardation, the highest score on any 1 of the 4 sleep items, highest score on any 1 appetite/weight item and highest score on either of the 2 psychomotor items. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between QIDS-SR16 total score at the individual time points being analyzed (Week 1, 4 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261946|NCT00420641|Secondary|Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology–Clinician-rated Version (QIDS-CR16) Total Score Over Week 10|QIDS-CR16 is a 16-item rating scale of depressive symptoms rated by the clinician. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score was obtained by adding scores of items of sad mood, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite or weight, concentration/decision making, suicidal ideation and psychomotor agitation/retardation, the highest score on any 1 of the 4 sleep items, highest score on any 1 appetite/weight item and highest score on either of the 2 psychomotor items. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between QIDS-CR16 total score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261947|NCT00420641|Secondary|Mean Change From Randomization in IDS– Self-Rated Version (SR) Total Score Over Week 10|The IDS-SR is a standardized 30-item, participant rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-SR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-SR total score at the individual time points being analyzed (Week, 1, 4 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261948|NCT00420641|Primary|Mean Change From Randomization at the End of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology–Clinician Rated (IDS-CR) Total Score|The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time point being analyzed (Week 10) to Randomization.|Week 0 (Randomization) and Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261967|NCT00420459|Primary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe).|Obtained at Baseline and Week 12||||units on a scale||Standard Deviation|Mean
1261949|NCT00420641|Primary|Change From Randomization at the End of the Treatment Phase (Week 10) in Bech Scale (6-item of 17-item Hamilton Depression Rating [HAMD-17] Scale) Score|The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. The rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time point being analyzed (Week 10) to Randomization.|Week 0 (Randomization) and Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261950|NCT00420641|Primary|Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time point being analyzed (Week 10) to Randomization.|Week 0 (Randomization) and Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1261951|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 3|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 3 (day 15)|Efficacy sample - Study eye|||Units on a scale 0-4||Standard Deviation|Mean
1261952|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 2|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 2 (day 8)|Efficacy population - Study eye|||Units on a scale 0-4||Standard Deviation|Mean
1261953|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 1|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 1 (day 1)|Efficacy sample, non-missing data|||Units on a scale 0-4||Standard Deviation|Mean
1261954|NCT00420628|Primary|Treatment Emergent Adverse Events|Study eye - Safety Population, At all visits 1,2,3|day 1, day 8, day 15|Safety population, Study eye|||participants|||Number
1261955|NCT00420628|Secondary|Investigators Global Assessment of the Clinical Condition|The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.|Visit 3, day 8|Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3)|||Participants|||Number
1261956|NCT00420511|Secondary|Proportion of Patients Achieving Sustained Normoglycemia Off Medication at 1-week Post-insulin Therapy||1 year|||||||
1261957|NCT00420511|Secondary|Time to Loss of Glycemic Control||1 year|||||||
1261958|NCT00420511|Secondary|Area-under-the-glucose-curve (AUCglucose) on Meal Test at 1 Year||1 year|||||||
1261959|NCT00420511|Secondary|Fasting Blood Glucose at 48 Weeks||48 weeks||||mmol/l||Inter-Quartile Range|Median
1261960|NCT00420511|Secondary|Insulinogenic Index Divided by HOMA-IR at 48 Weeks|Insulinogenic index was calculated as the incremental change in insulin from 0 to 30 minutes divided by the incremental change in glucose over the same period of time. Insulinogenic index divided by HOMA-IR provides an additional measure of beta-cell function. A higher value indicates better beta-cell function|48 weeks||||index of beta-cell function||Inter-Quartile Range|Median
1261961|NCT00420511|Primary|Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR|Area-under-the-C-peptide-curve (AUCCpep) and area-under-the-glucose-curve (AUCgluc) from 0 to 240 minutes during meal tests were calculated using the trapezoidal rule. Insulin resistance was assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Beta-cell function was assessed using the ratio of total AUCCpep to AUCgluc divided by HOMA-IR (AUCCpep/gluc/HOMA-IR), a measure of insulin secretion in the context of ambient insulin sensitivity, analogous to the disposition index and adaptation index. Higher AUCCpep/gluc/HOMA-IR is indicative of better beta-cell function.|48 weeks||||index of beta-cell function||Inter-Quartile Range|Median
1261962|NCT00420459|Secondary|The Vineland Maladaptive Behavior Subscales|The Vineland Adaptive Behavior Scales include an optional Maladaptive Behavior Index with 27 items. The Maladaptive Behavior Index is a composite of Internalizing, Externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The Maladaptive Behavior subscale yields raw scores (0-27).|Week 12|Data for this outcome measure are unavailable because the data file was lost during a server migration.||||||
1261963|NCT00420459|Secondary|The Vineland Adaptive Behavior Scales|Vineland Adaptive Behavior Scales are a valid and reliable test to measure a person's adaptive level of functioning. Vineland-II forms aid in diagnosing and classifying intellectual and developmental disabilities and other disorders, such as autism spectrum disorders and developmental delays. The content and scales are organized within a 4 domain structure: Communication, Daily Living, Socialization and Motor Skills. The adaptive behavior composite standard score is computed from the sum of standard scores from the domains and converted into the adaptive behavior composite standard score. Higher scores indicate a higher adaptive level of functioning.|Screen Visit|Data for this outcome measure are unavailable because the data file was lost during a server migration.||||||
1261964|NCT00420459|Secondary|Social Responsiveness Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment|Obtained at Baseline and Week 12||||units on a scale||Standard Deviation|Mean
1261968|NCT00420420|Other Pre-specified|Baseline: Cognition Summary Score (CSS)|The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Deviation|Mean
1261969|NCT00420420|Other Pre-specified|Baseline: ADAS-Cog Total Score|The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Deviation|Mean
1261970|NCT00420420|Other Pre-specified|Baseline: Short CNTB Summary Score.|The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Deviation|Mean
1261971|NCT00420420|Primary|Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score|The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Error|Mean
1261972|NCT00420420|Secondary|Week 4 Change From Baseline in Cognition Summary Score (CSS)|The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Error|Mean
1261973|NCT00420420|Primary|Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score.|The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Error|Mean
1261974|NCT00420407|Secondary|Secondary Objective is to Better Understand the Efficacy of Novel Endpoints of Resuscitation in the Management of Shock and the Ability of These Monitors to Predict Outcome After Trauma.||28 days|||||||
1261975|NCT00420407|Primary|The Primary Endpoint of This Study Will be Day 30 Mortality.||30 days||||Participants|||Number
1261976|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 130 mmHg|||mmHg||Standard Deviation|Mean
1261977|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 124 mmHg|||mmHg||Standard Deviation|Mean
1261978|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 120 mmHg|||mmHg||Standard Deviation|Mean
1261979|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 116 mmHg|||mmHg||Standard Deviation|Mean
1262408|NCT00418015|Primary|Duration of Intrathecal Analgesia Following Cesarean Delivery|Time until request for supplemental analgesia following intrathecal morphine/fentanyl for cesarean delivery|0 to 72 hours following cesarean delivery|Subjects that received fentanyl and morphine for postpartum analgesia after planned cesarean delivery were analyzed per protocol.|||Hours||Inter-Quartile Range|Median
1261982|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements|Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values|||mmHg||Standard Error|Median
1261983|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements|Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values|||mmHg||Standard Error|Mean
1261984|NCT00420342|Secondary|Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough|Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline|||mmHg||Standard Error|Mean
1261985|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements|The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline|||mmHg||Standard Error|Mean
1261986|NCT00420342|Primary|Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population|The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.|Baseline to Week 8|Primary analysis was Per Protocol Population (PP); no imputation methods used; patients with missing data had no BP values after baseline.|||mmHg||Standard Error|Mean
1261987|NCT00420342|Primary|Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population|The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.|Baseline to Week 8|Primary analysis used Full Analysis Set (FAS), which follows ITT principles; no imputation methods used; patients with missing data had no Blood Pressure (BP) values after baseline|||mmHg||Standard Error|Mean
1261988|NCT00420316|Secondary|Number of Subjects Reporting Intussusception (IS)|Intussusception is defined as the telescoping of the intestine.|During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)|The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.|||Subjects|||Number
1261989|NCT00420316|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.|||Subjects|||Number
1261990|NCT00420316|Secondary|Number of Subjects With Severe Gastroenteritis (GE)|Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
1261991|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
1261992|NCT00420316|Secondary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
1261993|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
1262409|NCT00418015|Primary|Duration of Intrathecal Fentanyl Analgesia|Time from intrathecal drug administration to request for analgesia either in laboring women of after cesarean delivery|Time (0-1440 minutes) to first analgesia request|Laboring parturients that received intrathecal fentanyl (25 micrograms) for initiation of labor analgesia were evaluated for this outcome per protocol.|||Minutes||95% Confidence Interval|Median
1261994|NCT00420316|Secondary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
1261995|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
1261996|NCT00420316|Primary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
1261997|NCT00420303|Primary|Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12|The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Baseline and 12 weeks|All randomized patients who received at least 1 dose of test article.|||units on scale||Standard Deviation|Mean
1261998|NCT00420303|Secondary|Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity|A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad.|12 weeks|All randomized patients who received at least 1 dose of test article.|||patients|||Number
1261999|NCT00420303|Primary|Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12|PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).|12 weeks|All randomized patients who received at least 1 dose of test article. Last observation carried forward (LOCF)|||mm||Standard Deviation|Mean
1262000|NCT00420290|Secondary|Lean Body Mass (LBM)|LBM is a measurement of body composition in terms of lean body mass as determined using Dual Energy X-ray Absorptiometry (DEXA) performed 1 to 2 hours after dialysis.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||kg||Standard Deviation|Mean
1262001|NCT00420290|Secondary|Serum Albumin|Albumin is a sensitive laboratory assay for serum levels of albumin, which is a biomarker of nutrition.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||g/dl||Standard Deviation|Mean
1262002|NCT00420290|Secondary|Serum Prealbumin|Prealbumin is a sensitive laboratory assay for serum levels of prealbumin, which is a biomarker of nutrition.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||mg/dl||Standard Deviation|Mean
1262003|NCT00420290|Secondary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interlukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||pg/ml||Standard Deviation|Mean
1262004|NCT00420290|Primary|High Sensitivity C-reactive Protein (hsCRP)|hsCRP is a sensitive laboratory assay for serum levels of C-reactive protein, which is a biomarker of inflammation.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||mg/dl||Standard Deviation|Mean
1262005|NCT00420238|Secondary|Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24|Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.|||percent of participants|||Number
1262006|NCT00420238|Secondary|Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12|Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 2, Week 4, Week 8, Week 12|mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.|||percent of participants|||Number
1262007|NCT00420238|Secondary|Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24|"Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 14, Week 18, Week 24|Open-label population. In the case of missing data, no replacement or imputation method was performed.|||percent of participants|||Number
1262008|NCT00420238|Secondary|Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12|"Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||percent of participants|||Number
1262009|NCT00420238|Secondary|Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24|Percent of participants with normal (<6 milligrams per liter) and abnormal (>= 6 milligrams per liter) C-Reactive Protein.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||percent of participants|||Number
1262010|NCT00420238|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24|Change from baseline in C-reactive Protein (CRP).|Week 14, Week 18, Week 24|Open-label population; LOCF.|||milligrams per liter||95% Confidence Interval|Mean
1262011|NCT00420238|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12|CRP is a marker of inflammation. A higher level is consistent with inflammation.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. LOCF.|||milligrams per liter||95% Confidence Interval|Least Squares Mean
1262012|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the C-reactive Protein curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||milligrams per liter||95% Confidence Interval|Least Squares Mean
1262013|NCT00420238|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||millimeters per hour||95% Confidence Interval|Mean
1262014|NCT00420238|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.|||millimeters per hour||95% Confidence Interval|Least Squares Mean
1262015|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the Erythrocyte Sedimentation Rate curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters per hour||95% Confidence Interval|Least Squares Mean
1262016|NCT00420238|Secondary|Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24|Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) due to AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
1262017|NCT00420238|Secondary|Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12|Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) because of AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = subgroup of subjects who reported performing daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit (Week 2 through Week 12).|||units on scale||95% Confidence Interval|Least Squares Mean
1262018|NCT00420238|Secondary|Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24|Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters (cm).|Week 14, Week 18, Week 24|Open-label population; LOCF.|||centimeters||95% Confidence Interval|Mean
1262019|NCT00420238|Secondary|Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12|Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||centimeters||95% Confidence Interval|Least Squares Mean
1262031|NCT00420238|Secondary|Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober’s test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
1262020|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the Chest Expansion Test curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||centimeters||95% Confidence Interval|Least Squares Mean
1262021|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24|Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: >= 120 cm, to 9: 30 to 39.9 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
1262022|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: >= 120 cm, to 9: 30 to 39.9 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
1262023|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24|Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: <=0.7 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
1262024|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: <=0.7 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
1262025|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24|Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
1262026|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12|Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attemting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
1262027|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24|Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two tries on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
1262028|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two attempts on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
1262029|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24|Cervical rotation: measurement in degree to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||units on scale||95% Confidence Interval|Mean
1262030|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12|Cervical rotation: measurement of degrees to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. In the case of missing data, no replacement or imputation method was performed.|||units on scale||95% Confidence Interval|Mean
1269966|NCT00360334|Secondary|Change in TC to HDL Cholesterol Ratio|Change in TC to HDL cholesterol ratio from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||Ratio||Standard Error|Least Squares Mean
1262032|NCT00420238|Secondary|Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Least Squares Mean
1262033|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12|BASMI was composed of 5 measures; each measure scored 0-2 (0=normal mobility, 2=severe reduction); final score range: 0 to 10. Normalized net incremental area under the curve (AUC) = area between baseline and the BASMI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||millimeters||95% Confidence Interval|Least Squares Mean
1262034|NCT00420238|Secondary|Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)||Baseline, Week 12|mITT; N=number of subjects with evaluable data. In the case of missing data, no replacement or imputation method was performed.|||percent||95% Confidence Interval|Least Squares Mean
1262035|NCT00420238|Secondary|Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)||Baseline, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||liters||95% Confidence Interval|Least Squares Mean
1262036|NCT00420238|Secondary|Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12|Subject evaluation of the effect of their disease on well-being over the last week using a using a 100 millimeter Visual Anaog Scale; range: 0=none to 100=very important.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Mean
1262037|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24|Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very important.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
1262038|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12|Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=very important.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||units on scale||95% Confidence Interval|Least Squares Mean
1262039|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12|BAS-G was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=none to 100=very important. Normalized net incremental area under the curve (AUC) = area between baseline and the BAS-G curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
1262040|NCT00420238|Secondary|Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24|BASDAI subject rated components over last 48 hours using a 100 millimeter Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3)Overall level of pain/swelling in joints other than neck,back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening.|Week 14, Week 18, Week 24|Open-label population; in case of missing data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.|||units on scale||95% Confidence Interval|Mean
1262041|NCT00420238|Secondary|Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12|BASDAI subject rated components over last 48 hours using 100 mm Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3) Overall level of pain/swelling in joints other than neck, back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening, and morning stiffness subscale.|Week 2, Week 4, Week 8, Week 12|mITT; in case of mising data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.|||units on scale||95% Confidence Interval|Mean
1262042|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24|BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis (AS) in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
1262043|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12|BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on a scale||95% Confidence Interval|Least Squares Mean
1262044|NCT00420238|Secondary|Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24|Subject rating of last 48 hours, 100 mm Visual Analog Scale; range 0=easy to 100=impossible: 1) Putting on socks/tights without (w/o) help; 2) Bending forward from waist to pickup pen from floor w/o aid; 3) Reaching to high shelf w/o aid; 4) Getting out of armless dining room chair w/o using hands/other help; 5) Getting up off floor w/o help from lying on back; 6) Standing unsupported 10 minutes w/o discomfort; 7) Climbing 12-15 steps w/o handrail or walking aid; 8) Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C=component (number), Act=Activities.|||units on a scale||95% Confidence Interval|Mean
1262045|NCT00420238|Secondary|Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12|Subject rating of last 48 hours, 100 millimeter Visual Analog Scale; range 0=easy to 100=impossible: 1)Putting on socks/tights without (w/o) help; 2)Bending forward from waist to pickup pen from floor w/o aid; 3)Reaching to high shelf w/o aid; 4)Getting out of armless dining room chair w/o using hands/other help; 5)Getting up off floor w/o help from lying on back; 6)Standing unsupported 10 minutes w/o discomfort; 7)Climbing 12-15 steps w/o handrail or walking aid; 8)Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C = component (number), Act = Activities.|||units on a scale||95% Confidence Interval|Mean
1262046|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12|BASFI is a validated self assessment tool that determines the degree of functional limitation in ankylosing spondylitis (AS) patients using a 100 millimeter (mm) Visual Analog Scale (VAS) measuring level of ability with activities in the last 48 hours; range: 0=easy to 100=impossible. Higher score = greater limitation.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.|||units on scale||95% Confidence Interval|Least Squares Mean
1262047|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12|BASFI was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = easy to 100 = impossible. Normalized net incremental area under the curve (AUC) = area between baseline and the BASFI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
1262048|NCT00420238|Secondary|Change From Baseline in Total Back Pain at Weeks 14, 18, 24|Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
1262049|NCT00420238|Secondary|Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12|Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Least Squares Mean
1262050|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12|Total back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Total Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
1262051|NCT00420238|Secondary|Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24|Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
1262052|NCT00420238|Secondary|Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12|Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Least Squares Mean
1262053|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12|Nocturnal back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Nocturnal Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
1262054|NCT00420238|Secondary|Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24|Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
1262055|NCT00420238|Secondary|Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12|Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.|||units on scale||95% Confidence Interval|Least Squares Mean
1262056|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12|PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC) = area between baseline and the Physician Global Assessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N= number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
1262057|NCT00420238|Secondary|Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24|Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
1262058|NCT00420238|Secondary|Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12|Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Least Squares Mean
1262059|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12|PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC)=area between baseline and the Patient Global Asessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
1262060|NCT00420238|Secondary|Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24|Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||percent of participants|||Number
1262061|NCT00420238|Secondary|Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12|Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
1262062|NCT00420238|Secondary|Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||percent of participants|||Number
1262063|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
1262064|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||percent of particpants|||Number
1262065|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (versus baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
1262066|NCT00420238|Secondary|Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 units (millimeters) on a 0-100 scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population: all subjects who received at least 1 dose of open test article (Etanercept). LOCF.|||percent of participants|||Number
1262139|NCT00420004|Secondary|Pharmacokinetics: Predicted Maximal Concentration of LY2216684 at Steady State (Cmax,ss) at Week 8 Endpoint|Predicted maximal LY2216684 plasma concentrations at steady state (Cmax,ss) are reported, using the dose at the last visit in the study for participants included in the primary efficacy analysis.|Up to 8 weeks|All participants randomized to LY2216684 included in the primary efficacy analysis with a pharmacokinetic (PK) sample at the participants' final study visit.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1262067|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function,and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 millimeters (mm) on a 0-100 mm scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
1262068|NCT00420238|Secondary|Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|BASDAI subject assessment of discomfort, pain and fatigue was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very severe. BASDAI 50 response defined as at least a 50 percent (%) improvement (decrease) from baseline to observation (last observation carried forward) in the BASDAI. Baseline score minus score at observation divided by Baseline score * 100 = >=50%.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
1262069|NCT00420238|Primary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12|BASDAI subject asessment of discomfort, pain and fatigue measured using a 100 millimeter Visual Analog Scale; range: 0=none to 100=very severe. Normalized net incremental area under the curve (AUC) = area between baseline and the BASDAI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|Modified Intent-To-Treat (mITT) population: includes all randomized subjects who received at least 1 dose of blinded study drug. Last observation carried forward (LOCF).|||millimeters||95% Confidence Interval|Least Squares Mean
1262070|NCT00420212|Secondary|Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)|The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or a ≥1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed ≥12 weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution.|2 years|The analysis population consisted of the ITT population (all subjects who were randomized and received at least 1 dose of study medication) who had a baseline EDSS assessment. Analysis were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.|||Proportion of participants|||Number
1262071|NCT00420212|Secondary|Annualized Relapse Rate|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model, adjusted for baseline EDSS (≤ 2.0 vs. >2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.|2 years|The ITT population was defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.|||Relapses per year||95% Confidence Interval|Mean
1262072|NCT00420212|Secondary|Number of Subjects With Gadolinium (Gd)-Enhancing Lesions|"Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure Number of Gadolinium-enhancing T1-weighted lesions"|2 years|Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data & were included in the analysis. Missing data before the use of alternative MS medications & visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption|||Number of subjects|||Number
1262073|NCT00420212|Secondary|Number of Gadolinium-enhancing T1-weighted Lesions|The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group.|2 years|Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data & were included in the analysis. Missing data before the use of alternative MS medications & visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption|||Number of lesions||Standard Deviation|Mean
1262074|NCT00420212|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume|2 years|Of the 540 subjects included in the MRI cohort, 469 subjects (165 placebo, 152 BG00012 BID, 152 BG00012 TID) had post-baseline T2 data and were included in the analysis. Missing data before the use of alternative MS medications and visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption.|||Number of lesions||95% Confidence Interval|Mean
1262075|NCT00420212|Primary|Proportion of Subjects Relapsed|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.|2 years|The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.|||Proportion of subjects,confirmed relapse|||Number
1262076|NCT00420199|Secondary|Double-blind Period: Number of Participants With Positive Antibodies to Abatacept by Electrochemiluminescence (ECL) Assay|On-Rx=on treatment; post-Rx=post treatment. ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1.|Day 1 to Day 113|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262077|NCT00420199|Secondary|Double-blind Period:Number of Participants With Significantly Abnormal Changes in Vital Signs|Vital signs, which included blood pressure, heart rate, respiration, and temperature, were monitored predose and 1 hour after start of infusion. Changes in vital signs were determined to be significantly abnormal at the discretion of the investigator but were generally those that either exceeded, or failed to reach, normal parameters. Normal vital sign parameter ranges varied by site.|Days 1, 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262078|NCT00420199|Primary|Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis score=Follow-up synovitis score-baseline synovitis score.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and who had wrist synovitis assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
1262079|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results in Other Chemistries and Urinalysis Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; BL-baseline. Marked abnormality c: serum glucose:<65 mg/dL/>220 mg/dL; fasting serum glucose: <0.8* LLN/>1.5* ULN, or if BL<LLN, use 0.8*BL or >ULN, or if BL>ULN, use >2.0*BL or <LLN; total protein: <0.9*LLN/>1.1* ULN; albumin: <0.9*LLN,or if BL<LLN, use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN, use >2*BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, red blood cells, white blood cells):Use ≥2 when BL value missing or value ≥4,or when predose=0 or 0.5. Use ≥3 when predose=1. Use ≥4 when predose=2 or 3|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262080|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results for Electrolytes Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Marked abnormality: Sodium: <0.95*LLN/>1.05*ULN,or if BL<LLN, use 0.95*BL or >ULN,or if BL>ULN, use>1.05*BL or <LLN. Potassium: <0.9*LLN/>1.1* ULN,or if BL<LLN, use 0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN. Chloride: <0.9*LLN/>1.1*ULN, or if BL<LLN, use 0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN. Calcium: <0.8*LLN/>1.2*ULN, or if BL<LLN, use 0.75*BL or >ULN, or if BL>ULN, use>1.25*BL or <LLN. Phosphorous: <0.75*LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33*BL or <LLN.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262081|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results for Liver and Kidney Function Meeting Criteria for Marked Abnormality|ULN=upper limit of normal; BL=baseline. Marked abnormality criteria: Alkaline phosphatase: >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase: >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase: >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase: >2*ULN, or if BL>ULN, use >3*BL; Bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2*BL; creatinine: >1.5*BL.|From Day 1 to Day 113, and including up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262082|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality|BL=baseline; LLN=lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL. Hematocrit: <0.75*BL. Erythrocytes: <0.75*BL. Platelets: <0.67*LLN/>1.5*ULN, or if BL <LLN, use 0.5*BL/<100,000 mm^3. Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN, use >1.2*BL/<LLN. Neutrophils+bands: <1.0*10^3 c/uL. Eosinophils: >0.750*10^3 c/uL. Basophils: > 400 mm^3. Monocytes: >2000 mm^3. Lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262083|NCT00420199|Secondary|Double-blind Period: Number of Participants With Peri-infusional AEs of Special Interest|Peri-infusional AEs are AEs occurring during the first 24 hours after the start of study drug infusion. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs considered possibly, probably, or certainly related to study treatment were graded according to Common Terminology Criteria for Adverse Events, Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262103|NCT00420095|Secondary|Hypoglycemia Rate Per Participant Per 30 Days|Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.|over 12 weeks of each treatment period|Includes all randomized patients who had at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||events/30 days||95% Confidence Interval|Mean
1262084|NCT00420199|Secondary|Double-blind Period: Number of Participants With Acute Infusional AEs of Special Interest|Acute infusional AEs are AEs with onset during the first hour after the start of study drug infusion. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs considered possibly, probably, or certainly related to study treatment were graded according to Common Terminology Criteria for Adverse Events ,Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262085|NCT00420199|Secondary|Double-blind Period: Number of Participants With Infections/Infestations of Special Interest|Infections/Infestations of Special Interest are AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262086|NCT00420199|Secondary|Double-blind Period: Number of Participants With AEs of Special Interest|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including serious, opportunistic, and all other infections; autoimmune disorders; neoplasms; acute infusional AEs (prespecified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (prespecified AEs occurring within 24 hours of start of infusion).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262087|NCT00420199|Secondary|Double-blind Period: Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
1262088|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Marker of Synovial Tissue Metabolism (Creatinine-corrected Urinary Glucosyl-Galactosyl-Pyridinoline [UGGPC])|Glucosyl-galactosyl-pyridinoline (Glc-Gal-PYD) is a specific biochemical marker reflecting the degradation of the synovial tissue membrane. It is a glycosylated derivative of the collagen crosslink pyridinoline, and it is present in significant amounts only in the synovial membrane; it is absent from bone and present in minutes amounts in cartilage and other soft tissues. Increased urinary levels of Glc-Gal-PYD have been found in early and long-standing rheumatoid arthritis, high levels being associated with rapid destruction.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
1262089|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in a Systemic Marker of Cartilage Degradation (Creatinine-corrected Urinary Carboxyterminal Crosslinking Telopeptide of Type II Collagen [UCTX2C])|Urinary CTX-II is a biochemical marker of type II collagen breakdown. In participants with early rheumatoid arthritis, increased levels of CTX-II can be predictive of rapid radiographic progression over periods of 1 to 5 years. These markers of cartilage destruction can predict progression of joint damage, independent of clinical and biologic indices of disease activity and baseline joint damage.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
1262090|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Destruction (Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen [CTX-I] and Serum Pyridinoline Cross-linked Telopeptide Domain of Type I Collagen [ICTP])|CTX-I and ICTP are biochemical markers of bone resorption or bone degradation|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
1262091|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Formation: Osteocalcin and Serum Intact N-terminal Propeptide of Type I Procollagen (PINP)|PINP and osteocalcin are markers of bone formation. Osteocalcin is synthesized by osteoblasts and is associated with osteoblast synthetic activity. Osteoblasts secrete type 1 procollagen, and cleavage of large fragments from the carboxy and amino terminal ends result in formation of mature type 1 collagen and production of PINP fragments.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
1262092|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in RAMRIS Scores|RAMRIS Score=sum of core components: Synovitis (S), Osteitis (O), and Erosion (E) Scores. S scored 0 (none) to 9 (maximum distension of synovial cavity); O scored 0 (none) to 69 (maximum articular bone involvement); E scored 0 (none) to 230 (maximum erosion of articular bone). RAMRIS=S+O+E Scores. RAMRIS minimum score=0 (normal), maximum=308 (severe structural damage). Adjusted change from baseline in RAMRIS=mean RAMRIS at Day 113-mean RAMRIS at baseline. Adjustment based on ANCOVA model: treatment=factor, baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had RAMRIS assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
1262494|NCT00416598|Secondary|Relationship Between Busulfan Pharmacokinetics (Area Under the Curve) and Relapsed Disease|Results from busulfan pharmacokinetics will be pooled with those from CALGB 19808.|At baseline, after 2, 4, and 6 hours after the start of busulfan infusion|||||||
1262093|NCT00420199|Secondary|Double-blind Period: Baseline Mean RAMRIS Scores|RAMRIS score is the sum of its core components: Synovitis Score, Osteitis Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Osteitis scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Osteitis Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Osteitis Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Baseline|All randomized participants who received at least 1 dose of study medication and had RAMRIS assessments available at baseline.|||units on a scale||Standard Deviation|Mean
1262094|NCT00420199|Secondary|Double-blind Period: Number of Participants With Newly Involved Joints in Bone Erosion, Edema/Osteitis, and Synovitis|Bone erosion and osteitis were assessed at a total of 23 anatomic locations according to erosion (for bone erosion) or involvement (for osteitis) of the original articular bone. Synovitis assessed as above-normal post-gadolinium enhancement in 3 wrist regions: distal radioulnar joint, radiocarpal joint, and intercarpal and carpometacarpal joints.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had erosion, edema, and synovitis assessments available at baseline and Day 113.|||participants|||Number
1262095|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in Osteitis OMERACT 6 Scores|Osteitis assessed at 23 anatomic locations: 15 in 1 wrist and 8 in attached. Each site scored in 1.0 increments, indicating involvement of original articular bone (0=none to 3=severe). Total score for hands/wrists is sum of scores for each location. Maximum score per hand/wrist is 23 (total anatomic locations)*3 (maximum score per joint)=69. Minimum score=0(normal). Increasing score=greater severity. Adjusted mean change from baseline in osteitis score=mean score at Day 113-mean score at baseline. Adjustment based on ANCOVA model with treatment=factor and baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had osteitis OMERACT 6 assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
1262096|NCT00420199|Secondary|Double-blind Period: Baseline Mean Osteitis OMERACT 6 Scores|Osteitis assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity.|At baseline|All randomized participants who received at least 1 dose of study medication and had osteitis OMERACT 6 assessments available at baseline.|||units on a scale||Standard Deviation|Mean
1262097|NCT00420199|Primary|Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis=Follow-up synovitis score-baseline score.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had wrist synovitis assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
1262098|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in Erosion OMERACT 6 Scores|Bone erosion assessed at 23 anatomic locations: 15 in 1 wrist and 8 in attached hand. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. Total erosion score for hands/wrists is sum of the individual scores for each location. Thus the maximum score per hand/wrist is 230. Increasing score=greater severity. Adjusted change from baseline in erosion score=mean score at Day 113-mean erosion score at baseline. Adjustment based on ANCOVA model with treatment=factor and baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had erosion OMERACT 6 assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
1262099|NCT00420199|Secondary|Double-blind Period: Baseline Mean Erosion OMERACT 6 Scores|Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.|At baseline|All randomized participants who received at least 1 dose of study medication and had erosion OMERACT 6 assessments available at baseline.|||units on a scale||Standard Deviation|Mean
1262100|NCT00420199|Primary|Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS)|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis = Follow-up synovitis score - baseline score.|At baseline|All randomized participants who received at least 1 dose of study medication and had synovitis assessments available at baseline.|||units on a scale||Standard Deviation|Mean
1262101|NCT00420147|Primary|Knee Adduction Moment After 12 Months||12 months||||Nm/(kg-m)||Standard Deviation|Mean
1262102|NCT00420147|Primary|Knee Adduction Moment at Baseline||Baseline||||Nm/(kg-m)||Standard Deviation|Mean
1262156|NCT00419952|Secondary|Onset of Effect Questionnaire (OEQ)|Number of participants with positive response to Item 2 in questionnaire “During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of “strongly agree” or “somewhat agree”|1 week|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Participants|||Number
1262104|NCT00420095|Secondary|Number of Participants With Laboratory Parameters Significantly Different From Baseline|Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.|Baseline and 12 weeks of each treatment|Includes all randomized patients receiving at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||participants|||Number
1262105|NCT00420095|Secondary|Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%|Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.|12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||participants|||Number
1262106|NCT00420095|Secondary|Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment|Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.|||units of insulin||95% Confidence Interval|Mean
1262107|NCT00420095|Secondary|Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment|Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.|||millimoles/Liter||95% Confidence Interval|Mean
1262108|NCT00420095|Secondary|Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment|Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.|Baseline and at 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||percent of glycosylated hemoglobin||95% Confidence Interval|Mean
1262109|NCT00420095|Primary|Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint|Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||percent of glycosylated hemoglobin||95% Confidence Interval|Mean
1262110|NCT00420056|Secondary|Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21|Plasma PD 0332991 concentration at Cycle 1 Day 21 was analyzed. Change from baseline in biomarkers (Ki-67 composite score, Cyclin D1 composite score, phospho-Rb positive cells) and SUVmax (FLT-PET SUVmax, FDG-PET SUVmax) at Cycle 1 Day 21 were analyzed. Correlation between PD 0332991 concentration and change in biomarkers (concentration versus Ki-67, concentration versus Cyclin, and concentration versus phospho-Rb) and SUVmax (concentration versus FLT-PET SUVmax, concentration versus FDG-PET SUVmax) was then assessed. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|PD 0332991 concentration was analyzed using pharmacokinetic analysis set (participants in FAS who had also completed pharmacokinetic blood sampling for at least 1 day); SUVmax and biomarkers were analyzed using imaging analysis set and tumor analysis set respectively. n= participants evaluable for this measure for specified comparisons.|||correlation coefficient|||Number
1262111|NCT00420056|Secondary|Time to Tumor Progression (TTP)|Time in months from date of first dose of study medication to first documentation of objective tumor progression (PD). TTP= (last known progression-free date minus date of first dose of study medication plus 1) divided by 30.44. PD was defined as greater than 50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.|||months||95% Confidence Interval|Median
1262112|NCT00420056|Secondary|Duration of Response (DR)|Time in months from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to objective tumor progression (PD) or death due to any cause. DR= (date of first documentation of PD or death, minus the date of first CR or PR plus 1) divided by 30.44. CR= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before start of therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration. PR= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by >50% in SPD, no new sites of disease. PD= >50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|For duration of response, the number of participants experiencing objective response was less than 50%, and therefore, it was not feasible to calculate duration of response using Kaplan-Meier method. Hence, no participant was analyzed for this outcome measure.||||||
1262113|NCT00420056|Secondary|Percentage of Participants With Objective Response|OR is defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR). Confirmed responses are those that persist on repeat imaging study 4 weeks after initial documentation of response. Complete response (CR)= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration; Partial response (PR)= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by >50% in SPD, no new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.|||percentage of participants||95% Confidence Interval|Number
1262114|NCT00420056|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as >50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease. PFS= (first event date minus the first dose date plus 1) divided by 30.44.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.|||months||95% Confidence Interval|Median
1262115|NCT00420056|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The events which were considered treatment-related by sponsor and/or investigator were reported.|Day 1 up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
1262116|NCT00420056|Primary|Number of Participants With Treatment-Emergent Adverse Events by Severity|AE = any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. Severity was assessed as: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe) = unacceptable or intolerable events, significantly interrupting usual daily activity, and requiring systemic medication therapy/other treatment; Grade 4 (Life-threatening) = events causing participant to be in imminent danger of death; Grade 5 (Death) = death related to an AE. Treatment-emergent events = between first dose of study medication and up to 28 days after last dose, that were absent before treatment or that worsened relative to pre-treatment state. A participant may be represented in more than 1 category.|Day 1 up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
1262117|NCT00420056|Primary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory test abnormality: Hematology (Hemoglobin [<0.8*lower limit of normal {LLN}], Platelets [<0.5*LLN/ >1.75*upper limit of normal {ULN}], White blood cells [<0.6*LLN/ >1.5*ULN], Lymphocytes, Neutrophils [<0.8*LLN/ >1.2*ULN], Basophils, Eosinophils, Monocytes [>1.2*ULN]); Liver Function (Total bilirubin [>1.5*ULN], Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Alkaline phosphatase [>0.3*ULN], Total protein, Albumin [<0.8*LLN/ >1.2*ULN]); Renal Function (Blood urea nitrogen, Creatinine [>1.3*ULN], Uric acid [>1.2*ULN]); Electrolytes (sodium [<0.95*LLN/ >1.05*ULN], potassium, chloride, calcium, magnesium [<0.9*LLN/ >1.1*ULN], phosphate [<0.8*LLN/ >1.2*ULN]); Other (Glucose [<0.6*LLN/ >1.5*ULN]).|Baseline up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
1262118|NCT00420056|Primary|Cyclin D1 Composite Score at Cycle 1 Day 21|Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1262119|NCT00420056|Primary|Cyclin D1 Composite Score at Baseline|Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1262120|NCT00420056|Primary|Ki-67 Composite Score at Cycle 1 Day 21|Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1263191|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- OC|Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||ng/mL||Standard Deviation|Mean
1262121|NCT00420056|Primary|Ki-67 Composite Score at Baseline|Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1262122|NCT00420056|Primary|Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of tumor cells||Standard Deviation|Mean
1262123|NCT00420056|Primary|Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline|Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of tumor cells||Standard Deviation|Mean
1262124|NCT00420056|Primary|Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)|OR: CR= disappearance of all clinical/radiographic evidence of disease, disease related symptoms and biochemical abnormalities, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeat bone marrow aspiration; PR= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions regressed by >50% in SPD, no new sites of disease; SD= response <PR and no PD, documented >=1 time after start of therapy, no new sites of disease; PD= >50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease. PET response: CR= mean SUVmax same as background; PR= mean SUVmax <75% of baseline; PD= mean SUVmax >125% of baseline; SD= mean SUVmax >=75% of baseline but <=125% of baseline. Correlation was reported as conjoint number of participants with PET response at Cycle 1 Day 21 and OR at end of study.|Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for OR|PET response was analyzed using Imaging analysis set and OR was analyzed using response analysis set (all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed).|||participants|||Number
1262125|NCT00420056|Primary|Correlation Between Positron Emission Tomography (PET) Response and Progression-Free Survival (PFS)|PET response was defined as complete response (CR) = mean SUVmax same as of background; partial response (PR) = mean SUVmax less than (<) 75 percent (%) of baseline; progressive disease (PD) = mean SUVmax greater than (>) 125% of baseline; stable disease (SD) = mean SUVmax greater than or equal to (>=) 75% of baseline and mean SUVmax less than or equal to (<=) 125% of baseline. PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as >50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.|Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for PFS|Analysis for this outcome measure was not run as there were so few responders.||||||
1262126|NCT00420056|Primary|Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Change from baseline in SUVmax was assessed using [(18)F]-FLT-PET and [(18)F]-FDG-PET techniques.|Baseline, Cycle 1 Day 21|Imaging analysis set included participants in FAS who completed baseline [(18)F]-FDG-PET and [(18)F]-FLT-PET, and at least 1 on-treatment (Day 21) PET.|||standard uptake value (SUV)||Standard Deviation|Mean
1262127|NCT00420056|Primary|Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in [(18)F]-FDG-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline [(18)F]-FDG-PET and [(18)F]-FLT-PET, and at least 1 on-treatment [Day 21] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).|||correlation coefficient|||Number
1262137|NCT00420004|Secondary|Change From Baseline to Week 8 in the 21-item Hamilton Depression Rating Scale (HAM-21) Total Score|The HAMD-21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 60 (severely depressed). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Baseline, Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline HAMD-21 value.|||units on a scale||Standard Error|Least Squares Mean
1262128|NCT00420056|Primary|Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in [(18)F]-FLT-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline [(18)F]-fluorodeoxyglucose PET [FDG-PET] and [(18)F]-FLT-PET, and at least 1 on-treatment [Day 21] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).|||correlation coefficient|||Number
1262129|NCT00420017|Secondary|Number of Participants With Adverse Effects|Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)|7 days|Per protocol|||patients|||Number
1262130|NCT00420017|Secondary|Length of Post-surgical Intensive Care Unit Stay||7 days||||hours||Inter-Quartile Range|Median
1262131|NCT00420017|Secondary|Length of Post-surgical Hospital Stay||Duration of hospitalization||||days||Inter-Quartile Range|Median
1262132|NCT00420017|Primary|Incidence of Atrial Fibrillation||7 days|Analysis was per protocol|||participants|||Number
1262133|NCT00420004|Secondary|Cognitive Assessment Battery: Change From Baseline in Trail Making A up to Week 8 Endpoint|Trail Making A is a neurocognitive test associated with general brain function. While being timed, the participant is instructed to connect 25 randomly placed circled numbers on a page in numerical sequence without lifting their pencil. If a participant makes a mistake, the mistake is pointed out and the participant must start again from the last correct circle. The total time to complete the task (up to 300 seconds, with a lower value indicating better brain function) is recorded. Least squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline Trail Making A value. Last observation carried forward (LOCF) methodology was used.|||seconds||Standard Error|Least Squares Mean
1262134|NCT00420004|Secondary|Cognitive Assessment Battery: Change From Baseline in Two Digit Cancellation Test up to Week 8 Endpoint|The Two Digit Cancellation Test (2DCT) is a clinical adaptation of the visual search tasks that have been used to investigate cognitive processes involved in attention and visual information processing. For this test, the participant is presented with a piece of paper containing rows of digits. At the top of the page are two target digits. The participant is instructed to examine each row of digits working from top to bottom and left to right crossing off each number that matches either of the two numbers at the top of the page. The number of targets hit, number of errors, and number of times the participant had to be reminded of the task are recorded for the 45-second test. The 2DCT composite cognitive score is calculated as the number of targets hit – number of errors – number of reminders. 2DCT score ranges 0-40 with higher score indicating better cognition. Least squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline 2DCT value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
1262135|NCT00420004|Secondary|Cognitive Assessment Battery: Change From Baseline in Symbol Digit Substitution Test (SDST) up to Week 8 Endpoint|The SDST is an attention-demanding psychomotor component based on the Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale. The participant is given a symbol/digit code in which each of the digits 1 through 9 is paired with a different symbol. Below the code, a series of symbols selected from those in the code are presented in an irregular order. The participant is instructed to write the number that is appropriate for each symbol in the space below each symbol and to complete as many correct digits as possible within a 90-second test period. For this test, the number of attempts and number of correct digits is collected. The percentage of correct digits is presented based on the number of correct digits divided by the number of attempts, multiplied by 100 (score ranged from 0 to 100% correct). Least squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline SDST value. Last observation carried forward (LOCF) methodology was used.|||percentage of correct digits||Standard Error|Least Squares Mean
1262136|NCT00420004|Secondary|Cognitive Assessment Battery: Change From Baseline in Word List Learning and Delayed Recall Test (WLDRT) up to Week 8 Endpoint|The WLDRT is a test of visual learning and recall. Participants are shown a series of words (commonly used nouns) and asked to say each of the words aloud, then are asked to recall the words and the total number of correct words recalled is recorded (possible score ranged from 0 to 15 words). The process is repeated 3 times. The Word List Learning Test score is calculated as the average number of words recalled during the first 3 trials. After a 30-minute delay, participants are again asked to recall the words, and the total number of correct words remembered after the delay is recorded as the Delayed Recall Test score. The baseline value was the last non-missing value before the first randomized double-blind study drug administration. Least Squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to week 8|All randomized participants who received at least one dose of double-blind study drug and who have a baseline and at least one post-baseline WLDRT value. Last observation carried forward (LOCF) methodology was used.|||number of correct words||Standard Error|Least Squares Mean
1262138|NCT00420004|Secondary|Number of Participants With at Least 1 Serious Adverse Event (Safety and Tolerability)|The number of participants with at least one serious adverse event, regardless of causality is reported cumulatively through Week 8. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.|Baseline through Week 8|All randomized participants.|||Participants|||Count of Participants
1262140|NCT00420004|Secondary|Change From Baseline to Week 8 in Fatigue Severity Scale|Fatigue Severity Scale (FSS) is a 9-item measure of fatigue severity. Each item is scored by the participant on a scale of 1 (“Disagree”) to 7 (“Agree”), with a higher score indicating a stronger agreement with the item statement regarding the participant’s fatigue symptoms. The FSS total score ranges from 1 to 7, and is obtained by averaging the responses to the 9 items. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Baseline, Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline FSS value.|||units on a scale||Standard Error|Least Squares Mean
1262141|NCT00420004|Secondary|Change From Baseline in Insomnia Severity Index up to Week 8 Endpoint|The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the participant's perception of his or her insomnia. The ISI score is calculated as the sum of the responses to the 7 items of the ISI scale. Each item is rated on a 0 to 4 scale and the total score ranges from 0 to 28 with a higher score suggesting more severe insomnia.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline ISI value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1262142|NCT00420004|Secondary|Change From Baseline in Arizona Sexual Experiences Scale up to Week 8 Endpoint|The Arizona Sexual Experiences Scale (ASEX) is used to assess sexual functioning in both males and females. The ASEX total score for the male and female version is calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline ASEX value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1262143|NCT00420004|Secondary|Change From Baseline in Modified Overt Aggression (OAS-M) Scale up to Week 8 Endpoint|OAS-M is a clinician-administered semistructured interview designed to assess various manifestations of aggressive behavior. Final scores are rated on 3 scales: Aggression (Agg), Irritability (Irrt), Suicidality (Suic). Agg scale has 4 subscales: Verbal Assault (Aslt), Aslt Against Objects, Aslt Against Others, Aslt Against Self; each item is scored 0-5, multiplied by the frequency of the behavior, then summed together. Agg total score is the weighted sum of the subscale scores (weights: 1=Verbal Aslt, 2=Aslt Against Objects, 3=Aslt Against Others, 4=Aslt Against Self). The Irrt scale has 2 subscales: Global Irrt, Subjective Irrt. Suic scale has 3 subscales: Suicidal Tendencies, Intent of Attempt, Lethality of Attempt. The 2 Irrt and 3 Suic subscales are rated on 6 or 7 point scales from 0=none/not at all to 6/7=very extreme. The total score ranges from 0-10 for the Irrt scale and 0-16 on the Suic scale. Least Squares means were adjusted for treatment, investigator, and baseline s|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline OAS-M value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
1262144|NCT00420004|Secondary|Change From Baseline in Beck Scale for Suicide Ideation up to Week 8 Endpoint|Beck Scale for Suicide Ideation (BSI) is a 21-item participant-completed questionnaire designed to assess severity of suicidal ideation in adults and adolescents. The BSI total score is calculated as the sum of the responses (rated from 0 to 2 in terms of severity) to the first 19 items of the BSI scale. The BSI total score ranges from 0 to 38, with a higher score indicating a higher degree of suicide ideation.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline BSI value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1262145|NCT00420004|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology Total Score up to Week 8 Endpoint|The Quick Inventory of Depressive Symptomatology is a 16-item participant-rated measure of depressive symptomatology. There were 4 possible answers per question that are specific to the question; each question (Q) was scored 0 (no problems) to 3 (increased symptoms). The total score was the sum of the highest number from Q1-4, number from Q5, highest number from Q6-9, total for Q10-14, and the highest number from Q15-16. The total score ranges from 0 to 27 with higher scores indicative of greater severity of depression. Least Squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline Quick Inventory of Depressive Symptomatology value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
1262146|NCT00420004|Secondary|Change From Baseline on the 36-item Short-Form (SF-36) Health Status Survey Mental and Physical Components up to Week 8 Endpoint|The SF-36 Health Status Survey is a generic, health-related scale assessing a participant’s quality of life on 8 domains: general health (GH), physical functioning (PF), role-physical, role-emotional, social functioning, bodily pain, vitality, and mental health. Each domain is scored by summing the individual items (GH [range: 5-25]; PF [range: 10-30]; role-physical [range: 4-8]; role-emotional [range: 3-6]; social functioning [range: 2-10]; bodily pain [range: 2-11]; vitality [range: 4-24]; mental health [range: 5-30]) and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores (mental component and physical component scores) were constructed based on the 8 SF-36 domains. Mental component summary and physical component summary scores range from 0 to 100 (higher scores indicate better health status).|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline SF-36 Health Status Survey value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1262157|NCT00419952|Secondary|Diary Assessments - Asthma-control Day|Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered “no” to having symptoms and “0” to the use of rescue medication that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||percentage of Asthma-control day||95% Confidence Interval|Least Squares Mean
1262147|NCT00420004|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score up to Week 8 Endpoint|The HAMA is a 14-item assessment used to assess the severity of anxiety. The investigator talked to the participant about the symptoms he or she experienced during the previous week. Each item was scored using a 5-point scale (0=not present to 4=very severe). The total score of HAMA ranged from 0 (normal) to 56 (severe). Least Squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline HAMA value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
1262148|NCT00420004|Secondary|Clinical Global Impression of Improvement Score at Week 8|The Clinical Global Impression of Improvement (CGI-I) scale measures the clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, and treatment-by-visit.|Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline CGI-I value.|||units on a scale||Standard Error|Least Squares Mean
1262149|NCT00420004|Secondary|Response and Remission Rates|A participant meets response criteria if there is at least a 50% reduction in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to the last observation carried forward (LOCF) endpoint visit. A participant meets remission criteria if the HAMD-17 total score is less than or equal to 7 at the LOCF endpoint visit. The percent of participants meeting criteria is summarized. HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed).|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline HAMD-17 total score value. Last observation carried forward (LOCF) methodology was used.|||percentage of participants|||Number
1262150|NCT00420004|Secondary|Change From Baseline to Week 8 in Maier-Philipp Subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17)|"The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The Maier-Phillip subscale of the HAMD-17 represents the 6 core symptoms of depression (items: 1=depressed mood, 2=feelings of guilt, 7=work and activities, 8=retardation, 9=agitation, 10=anxiety/psychic). The subscale scores range from 0 (normal) to 24 (severe). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit."|Baseline, Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline Maier-Philipp subscale value.|||units on a scale||Standard Error|Least Squares Mean
1262151|NCT00420004|Primary|Change From Baseline to Week 8 in the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score|The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Baseline, Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline HAMD-17 value.|||units on a scale||Standard Error|Least Squares Mean
1262152|NCT00419952|Secondary|Asthma Treatment Satisfaction Measure (ATSM)|Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.|Baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||units on a scale||95% Confidence Interval|Least Squares Mean
1262153|NCT00419952|Secondary|Forced Expiratory Volume in One Second (FEV1)|Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Litres||95% Confidence Interval|Least Squares Mean
1262154|NCT00419952|Secondary|Peak Expiratory Flow (PEF) in Morning|Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Liters/minute||95% Confidence Interval|Least Squares Mean
1262155|NCT00419952|Secondary|Onset of Effect Questionnaire (OEQ)|Number of participants with positive response to Item 5 in questionnaire “During the past week, you were satisfied with how quickly you felt your study medication begin to work.” The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of “strongly agree” or “somewhat agree”|1 week|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Participants|||Number
1262675|NCT00414453|Secondary|Safety (i.e., Number of Serious Adverse Events)|Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales|rating and review of any adverse events occurs at each visit|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
1262158|NCT00419952|Secondary|Diary Assessments - Symptom-free Day|Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered “no” to having symptoms that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||percentage of Symptom-free day||95% Confidence Interval|Least Squares Mean
1262159|NCT00419952|Secondary|Diary Assessments - Rescue-free Day|Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered “no” to having used rescue medication that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Percentage of Rescue Free Day||95% Confidence Interval|Least Squares Mean
1262160|NCT00419952|Secondary|Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment|Total ventricular runs – number of participants with shift normal (<1) to high (≥1) from baseline to week 2.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients.|||Participants|||Number
1262161|NCT00419952|Secondary|Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment|Total ectopic supraventricular (VE) beats – number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients|||Participants|||Number
1262162|NCT00419952|Secondary|Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment|Total ectopic ventricular (VE) beats – number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients.|||Participants|||Number
1262163|NCT00419952|Secondary|QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)|QT interval corrected using the Fridericia formula [QTc (Frid)] – Change from baseline to end of treatment|Baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||msec||95% Confidence Interval|Least Squares Mean
1262164|NCT00419952|Secondary|Asthma Exacerbations|Number of participants with at least 1 exacerbation|52 Weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Participants|||Number
1262165|NCT00419952|Primary|Total Number of Asthma Exacerbations|An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.|52 Weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Exacerbations|||Number
1262166|NCT00419926|Primary|Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death|To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|6 months|Per Protocol (PP) population.|||number of participants|||Number
1262167|NCT00419926|Secondary|Renal Function Assessed by Serum Creatinine at Each Visits||at 21 days, 84 days and 180 days|||||||
1262168|NCT00419926|Secondary|Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit|The Modification of Diet in Renal Disease (MDRD) formula was used to calculate the GFR. Serum creatinine levels, age, sex and race were used to estimate the GFR levels in mL/min/1.73m^2.|at 21 days, 84 days and 180 days|Intention to treat (ITT) population.|||(mL/min/1.73m^2)||Standard Deviation|Mean
1262169|NCT00419926|Secondary|Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death|The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|21 and 84 days|Per Protocol (PP) population.|||number of participants|||Number
1262170|NCT00419926|Secondary|Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death|The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|21 and 84 days|Intention to treat (ITT) population.|||number of participants|||Number
1262186|NCT00419757|Secondary|Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks|"Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.~Daily scale:~0 = No symptoms~1 = Mild symptoms~2 = Moderate symptoms~3 = Severe symptoms"|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
1262171|NCT00419926|Primary|Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death|To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|6 months|Intention to treat (ITT) population.|||number of participants|||Number
1262172|NCT00419770|Primary|Total Adverse Events||30 Days After End of Therapy||||Events|||Number
1262173|NCT00419770|Secondary|Survival, Radiographic Improvement, Clinical Response, Time to Survival, Deferasirox vs. Free Iron Level Correlation||Up to 90 days|||||||
1262174|NCT00419770|Secondary|Deferasirox Pharmacokinetic and Pharmacodynamic Parameters||7 days|||||||
1262175|NCT00419770|Primary|Global Response Rate (Composite of Clinical and Radiographic Response) at End of Study Drug Administration, as Determined by a Blinded Adjudication Committee||14 days|||||||
1262176|NCT00419770|Primary|Safety and Tolerability of Adjunctive Deferasirox Therapy in Patients Being Treated With LAmB for Mucormycosis||14 days|||||||
1262177|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications|Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
1262178|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication|Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
1262179|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index|Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
1262180|NCT00419757|Secondary|Physician Global Assessment|"The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as “Yes” and points 3, 4, 5 as No. Percent of Participants that gave positive responses."|Baseline and week 12|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Perscentage of Participants|||Number
1262181|NCT00419757|Secondary|Subject Global Assessment|"The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as “Yes” and points 3, 4, 5 as No. Percent of Participants that gave positive responses."|Baseline and week 12|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percent of Participants|||Number
1262182|NCT00419757|Secondary|Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment|Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of days||Standard Error|Least Squares Mean
1262183|NCT00419757|Secondary|Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment|Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of days||Standard Error|Least Squares Mean
1262184|NCT00419757|Secondary|Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment|Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||puffs/day||Standard Error|Least Squares Mean
1262185|NCT00419757|Secondary|Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks|Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of nights||Standard Error|Least Squares Mean
1262247|NCT00419003|Secondary|Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects|Response rate and side effect differences to IV ketamine infusion based on lamotrigine and placebo pretreatment groups|24, 48, or 72-hrs|||||||
1288246|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42|Estimated FEV1 after bronchodilator at Month 42|Month 42||||L||Standard Error|Mean
1262187|NCT00419757|Secondary|Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks|"Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.~Daily scale:~0 = No symptoms~1 = Mild symptoms~2 = Moderate symptoms~3 = Severe symptoms"|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
1262188|NCT00419757|Secondary|Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)|Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Liters/minutes||Standard Error|Least Squares Mean
1262189|NCT00419757|Secondary|Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline, 2, 6 and 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Liters||Standard Error|Least Squares Mean
1262190|NCT00419757|Secondary|"Percentage of Participants With Withdrawals Due to Pre-defined Asthma Events"|"Percentage of participants with Withdrawals Due to Pre-defined Asthma Events as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated."|12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of Participants|||Number
1262191|NCT00419757|Secondary|Percentage of Participants With Pre-defined Asthma Events|Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication|12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of Participants|||Number
1262192|NCT00419757|Primary|Morning Peak Expiratory Flow (AM PEF)|Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Liters/minutes||Standard Error|Least Squares Mean
1262193|NCT00419744|Primary|Rate of Exacerbations Per Subject-year|Rate of exacerbations per subject-year|12 months||||Rate|||Number
1262194|NCT00419744|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.|12 months||||Scores on a scale||Standard Deviation|Mean
1262195|NCT00419744|Secondary|Use of Rescue Medication|Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.|12 months||||Number of inhalations||Standard Deviation|Mean
1262196|NCT00419744|Secondary|Dyspnea Symptom Scores|Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.|12 months||||Scores on a scale||Standard Deviation|Mean
1262197|NCT00419744|Secondary|Evening PEF|Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.|12 months||||L/min||Standard Deviation|Mean
1262198|NCT00419744|Secondary|Morning Peak Expiratory Flow (PEF)|Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.|12 months||||L/min||Standard Deviation|Mean
1262199|NCT00419744|Secondary|Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.|12 months||||Liters (L)||Standard Deviation|Mean
1262200|NCT00419744|Primary|Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year|Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.|12 months||||Exacerbations|||Number
1262201|NCT00419445|Primary|To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid).|The proportion of subjects with Treatment Emergent Adverse Events.|Baseline to study completion||||% of subjects|||Number
1262202|NCT00419393|Secondary|Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months|Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.|Study entry through 12 months|Of the 190 subjects beginning the study, 49 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 12 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.|||percentage of subjects|||Number
1263160|NCT00411411|Primary|the Relative Increase in Meal-induced Total GLP-1 Secretion|Patients will be followed for 12 weeks with three meal test examinations; before treatment, after 1 week of treatment and after 12 weeks of treatment. Primary outcome is AUC GLP-1 (pM x 120 as stated).|12 weeks||||pM x 120 min||Standard Deviation|Mean
1262203|NCT00419393|Secondary|Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months|Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.|Study entry through 6 months|Of the 190 subjects beginning the study, 139 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 6 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.|||percentage of subjects|||Number
1262204|NCT00419393|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.|||number of subjects|||Number
1262205|NCT00419393|Primary|Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.|||number of subjects|||Number
1262206|NCT00419393|Primary|Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.|||number of subjects|||Number
1262207|NCT00419380|Secondary|Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit.|Outcome measure data table represents the absence of drainage at day- 14|14 days||||Ear|||Number
1262208|NCT00419380|Primary|Patency of the Tympanostomy Tube at the Day-14 Visit.||14 days|Analysis performed on ear level. Some participants received drops in both ears and thus both ears were included in analysis.|||Ear|||Number
1262209|NCT00419341|Other Pre-specified|Rate of Mild, Moderate, or Severe Local Reactions|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of injection site reaction, injection site bruising, infusion site scab, injection site cyst, injection site eczema, injection site irritation, injection site nodule, and injection site pain.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to 15 months|The ITT population included all subjects who were treated with IgPro20 during any study period.|||local reactions per infusion|Participants||Number
1262210|NCT00419341|Other Pre-specified|Rate of All AEs by Relatedness and Seriousness|The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|For the duration of the study, up to 15 months|The ITT population included all subjects who were treated with IgPro20 during any study period.|||AEs per infusion|Participants||Number
1262211|NCT00419341|Other Pre-specified|Minimum Concentration (Cmin) of Total Serum IgG at Steady State||Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.|||g/L||Standard Deviation|Mean
1262212|NCT00419341|Secondary|Tmax at Steady State|Timepoint of maximum concentration (Cmax)|Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.|||days||Full Range|Median
1262213|NCT00419341|Secondary|Maximum Concentration (Cmax) of Total Serum IgG at Steady State||Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.|||g/L||Standard Deviation|Mean
1262214|NCT00419341|Secondary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Every 4 weeks, throughout the 12-month efficacy period|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||g/L||Standard Deviation|Mean
1262215|NCT00419341|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||days per subject year|Participants||Number
1262216|NCT00419341|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||days|||Number
1262217|NCT00419341|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection (N = 7) and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||days per subject year|Participants||Number
1262218|NCT00419341|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal daily activities due to infections, for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||days|||Number
1262219|NCT00419341|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection (N = 71), and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.|||days per subject year|Participants||Number
1262220|NCT00419341|Secondary|Number of Infection Episodes (Serious and Non-serious)|Total number of infections for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||infections|||Number
1262221|NCT00419341|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the efficacy period (N = 96) divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.|||infection episodes per subject year|Participants|95% Confidence Interval|Number
1262222|NCT00419341|Secondary|Annualized Rate of Clinically Documented SBIs (PPE Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|Efficacy period: up to 12 months (week 13 to the completion visit)|The Per Protocol Efficacy (PPE) population included all subjects who completed the 12-month efficacy period according to the protocol-defined requirements.|||SBIs per subject year|Participants||Number
1262223|NCT00419341|Secondary|Annualized Rate of Clinically Documented SBIs (ITT Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the study for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|For the duration of the study, up to 15 months|The Intention To Treat (ITT) population included all subjects who were treated with IgPro20 during any study period.|||SBIs per subject year|Participants||Number
1262224|NCT00419341|Primary|Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)|Evaluate non-inferiority of steady-state IgG area under the concentration-time curves standardized to a 7-day period (sAUCs) for subcutaneous immunoglobulin (SCIG) (IgPro20) versus the sAUC under intravenous immunoglobulin (IVIG) (Privigen) treatment. The sAUC under IVIG was taken from the same subjects in a preceding study (either ZLB03_002CR [NCT00168025] or ZLB05_006CR [NCT00322556]).|Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment|The Per Protocol Pharmacokinetic (PPK) population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.|||days*g/L||Standard Deviation|Mean
1262225|NCT00419341|Primary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|Efficacy period: up to 12 months (week 13 to the completion visit)|The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.|||SBIs per subject year|Participants||Number
1262226|NCT00419315|Secondary|Percent Days of Heavy Alcohol Use|This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women).|6 months||||percentage of heavy drinking days||Standard Deviation|Mean
1262227|NCT00419315|Primary|Treatment Engagement|This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.|6 months||||percentage of participants engaged|||Number
1262265|NCT00418886|Secondary|Longitudinal Analysis of Lung Cancer Symptom Scale (LCSS) Total Score|"The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. LCSS total score is an average of all nine visual analogue patient scales from none (0 mm) to as much as it could be (100 mm)"|LCSS questionnaires are to be administered every 3 weeks after randomisation||||mms on a visual analogue scale||Standard Error|Least Squares Mean
1262228|NCT00419263|Secondary|Change From Baseline to Day 9 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 192 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||log10(TCID50/mL)||Full Range|Median
1262229|NCT00419263|Secondary|Change From Baseline to Day 5 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 96 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||log10(TCID50/mL)||Full Range|Median
1262230|NCT00419263|Secondary|Change From Baseline to Day 3 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 48 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||log10(TCID50/mL)||Full Range|Median
1262231|NCT00419263|Secondary|Change From Baseline to Day 2 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 24 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||log10(TCID50/mL)||Full Range|Median
1262232|NCT00419263|Secondary|Time to Resumption of Ability to Perform Usual Activities|The time to resumption of a subject’s self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment.|Up to 14 days|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||Days||95% Confidence Interval|Median
1262233|NCT00419263|Secondary|Time to Resolution of Fever|The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed.|Up to 14 days|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||Hours||95% Confidence Interval|Median
1262234|NCT00419263|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.|Up to 14 days|The intent-to-treat infected (ITTI) population included all randomized subjects who received study drug and had proven influenza by culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Of the 318 subjects in the ITTI population, one subject had insufficient data to determine Time to Alleviation of Symptoms.|||Hours||95% Confidence Interval|Median
1262294|NCT00418834|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262235|NCT00419159|Primary|The Number of Participants With Best Overall Response: Complete Response (CR, No Lesions), Partial Response (PR, 30% Decrease in Lesions), and Stable Disease (SD, None of the Above) According to Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments."|Imaging every 8 weeks|Full Analysis Set|||Participants|||Number
1262236|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit on Everolimus (RAD001)||Screening and Day 1 of cycles 2, 3, 4 and end of treatment|||||||
1262237|NCT00419159|Secondary|Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).|Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment.|From the first day of treatment until 28 days after discontinuation of study treatment|Safety set analysis|||Participants|||Number
1262238|NCT00419159|Secondary|Overall Survival (OS)|Overall survival defined as the time from date of first study treatment to the date of death due to any cause.|Every 3 months|Overall Survival [OS] was analyzed in Full Analysis Set [FAS].|||Months||95% Confidence Interval|Median
1262239|NCT00419159|Secondary|Progression-free Survival (PFS)|Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause.|Imaging every 8 weeks|Progression- Free Survival (PFS) was analyzed in Full Analysis Set [FAS].|||Months||95% Confidence Interval|Median
1262240|NCT00419159|Primary|Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments.~Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response)."|Imaging every 8 weeks|Per Protocol Set|||Percentage of participants||95% Confidence Interval|Number
1262241|NCT00419120|Secondary|Overall Safety Profile - Number of Participants Experiencing an Adverse Event|clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to the Adverse Event section for detailed information.|periodically within first 12 months as well as during long term follow up out to 5 years||||participants|||Number
1262242|NCT00419120|Primary|Number of Responders as Assessed by Compliance|Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders|12 months|The analysis population of the primary outcome measure is the all implanted population (Intent to Treat - ITT). There was no imputation of analysis measures.|||participants|||Number
1262243|NCT00419094|Secondary|The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase|Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.|112 days|Of the 57 (Keppra 1000 mg) subjects randomized, 54 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population.|||proportion of subjects||95% Confidence Interval|Number
1262244|NCT00419094|Secondary|The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase|The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.|||proportion of subjects||95% Confidence Interval|Number
1262245|NCT00419094|Secondary|The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase|The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.|||proportion of subjects||95% Confidence Interval|Number
1262246|NCT00419094|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase|Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Primary Efficacy analysis was conducted for the Keppra XR 2000 mg/day group only.|||proportion of subjects||95% Confidence Interval|Number
1262248|NCT00419003|Primary|Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression. The primary outcome for the initial phase of the trial was the 24-h MADRS score, which included all 10 MADRS items.|24 Hours||||scores on a scale||95% Confidence Interval|Mean
1262249|NCT00418977|Primary|Body Mass Index (BMI) Z-score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator|up to 1 year||||z-score||Standard Deviation|Mean
1262250|NCT00418977|Secondary|BMI Percentile|Body Mass Index (BMI) percentile. This is not a primary outcome variable.|up to 1 year||||percentile||Standard Deviation|Mean
1262251|NCT00418977|Secondary|BMI|body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year||||kg/m^2||Standard Deviation|Mean
1262252|NCT00418977|Secondary|Weight|This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year||||pounds||Standard Deviation|Mean
1262253|NCT00418977|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year||||inches||Standard Deviation|Mean
1262254|NCT00418964|Secondary|Percentage Distal Femoral Bone Mineral Density (BMD)Decrease|% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery|1 year|||||||
1262255|NCT00418964|Primary|International Knee Documentation Committee (IKDC)Knee Form 2000 Score|It is a score on a scale from 0 to 100. It is a knee-specific measure of symptoms, function and sports activity of subjects based on self-report. 0 represents the worst while 100 represents the best score. The higher the score, the better the knee function.|1 year||||Score on a scale||Standard Deviation|Mean
1262256|NCT00418951|Primary|Number of Participants With Invasive Fungal Infection|Endpoint was whether participant had an invasive fungal infection or not, a potentially fatal complication with leukemia patients. Efficacy defined as absence of proven and probable fungal infection. Probable fungal infection is: 1) Positive radiographic findings consistent with fungal infections documented on CT imaging: Lower respiratory tract infection: halo sign, air crescent-sign, or cavity within areas of consolidation; Sinus: erosion of sinus walls or extension of infection to neighboring structures, extensive skull base destruction; and/or 2) Two positive galactomannan index test.|35 days from the start of therapy for induction participants and 42 days for salvage participants.|Outcome evaluability required at least two doses of study drug.|||participants|||Number
1262257|NCT00418938|Secondary|Duration of Response|Duration of response is defined as time from first confirmed objective response to disease progression per modified RECIST version 1.0 (by central assessment).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.|||months||95% Confidence Interval|Median
1262258|NCT00418938|Secondary|Disease Control|Disease control is defined as incidence of objective response or stable disease on study up to starting a new anti-tumor therapy.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.|||% of participants||95% Confidence Interval|Number
1262259|NCT00418938|Secondary|Time to Progression|Time to progression is defined as time from the date of randomization to the date of radiographic disease progression per modified RECIST version 1.0 (per central assessment).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.|||months||95% Confidence Interval|Median
1262260|NCT00418938|Secondary|Time to Response|Time to response is defined as time from the date of randomization to the date of first confirmed objective response|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.|||months||Inter-Quartile Range|Median
1262261|NCT00418938|Secondary|Objective Response Rate|Objective response rate is defined as incidence of either a confirmed complete response (CR) or partial response (PR) on study up to starting a new anti-tumor therapy and will be based on modified RECIST version 1.0 (responder) by central assessment.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.|||% of patients||95% Confidence Interval|Number
1262262|NCT00418938|Secondary|Overall Survival|Overall survival is defined as time from the date of randomization to the date of death due to any cause. Subjects who have not died or are lost to follow-up at the analysis cutoff date will be censored at their last contact date.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.|||months||95% Confidence Interval|Median
1262263|NCT00418938|Primary|Progression-free Survival (PFS)|Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.|||months||95% Confidence Interval|Median
1262264|NCT00418886|Secondary|Longitudinal Analysis of Average Symptom Burden Index (ASBI) Score|"The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. ASBI is an average of the six symptom visual analogue patient scales from none (0 mm) to as much as it could be (100 mm)."|ASBI is a score taken from the Lung Cancer Symptom Scale (LCSS) questionnaires administered every 3 weeks after randomisation||||mms on a visual analogue scale||Standard Error|Least Squares Mean
1262266|NCT00418886|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Average Symptom Burden Index (ASBI) Score|Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days. The ASBI is derived from 6 of LCSS’s 9 items|ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomisation||||weeks||95% Confidence Interval|Median
1262267|NCT00418886|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score|TDS is the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days. The LCSS scale measures changes in symptoms associated with lung cancer.|LCSS questionnaires are to be administered every 3 weeks after randomisation||||weeks||95% Confidence Interval|Median
1262268|NCT00418886|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||weeks||95% Confidence Interval|Median
1262269|NCT00418886|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||Percentage of Participants|||Number
1262270|NCT00418886|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 6 weeks, progressive disease (PD) or NE."|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||Percentage of Participants|||Number
1262271|NCT00418886|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||months||95% Confidence Interval|Median
1262272|NCT00418886|Primary|Progression-Free Survival (PFS) in the Female Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||weeks||95% Confidence Interval|Median
1262273|NCT00418886|Primary|Progression-Free Survival (PFS) in the Overall Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||weeks||95% Confidence Interval|Median
1262274|NCT00418834|Other Pre-specified|Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262275|NCT00418834|Other Pre-specified|Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262276|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262277|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262278|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262279|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262280|NCT00418834|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262281|NCT00418834|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262282|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262283|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262284|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262285|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262286|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262287|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262288|NCT00418834|Other Pre-specified|Percent Change From Baseline in Triglycerides (TG) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262289|NCT00418834|Other Pre-specified|Percent Change From Baseline in Triglycerides (TG) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262290|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262291|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC) at Week 6||Baseline and Week 6|"Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis."|||Percent Change||95% Confidence Interval|Least Squares Mean
1262292|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseine and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262293|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1265634|NCT00394654|Secondary|Observed Maximum Nasal Lavage Concentration (Cmax)|Cmax of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1262295|NCT00418834|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1262296|NCT00418834|Secondary|Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12||Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Participants|||Number
1262297|NCT00418834|Secondary|Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6||Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Participants|||Number
1262298|NCT00418834|Secondary|Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12||Week 12|"Full Analysis Set (FAS): The FAS~population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind~study medication were included in the analysis."|||Participants|||Number
1262299|NCT00418834|Secondary|Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6||Week 6|"Full Analysis Set (FAS): The FAS population~includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at~least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication~were included in the analysis."|||Participants|||Number
1262300|NCT00418834|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|"Full Analysis Set (FAS): The FAS~population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind~study medication were included in the analysis."|||Percent Change||95% Confidence Interval|Least Squares Mean
1262301|NCT00418834|Primary|Percent Change From Baseline in LDL-C at Week 6||Baseline and Week 6|"Full Analysis Set (FAS): The FAS population~includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at~least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication~were included in the analysis."|||Percent Change||95% Confidence Interval|Least Squares Mean
1262302|NCT00418717|Secondary|Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. In this analysis, the AUC is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). Blood samples were taken on day 0 of PK analysis and collected every day after for 7 days for weeks 4 and 12.|7 days after week 4 and 7 days after week 12|The analysis population was the Pharmacokinetic (PK) subset, which included all patients who completed the 25 mg BW dose treatment period, received at least 1 dose of 50 mg QW and elected to participate in the PK assessment. Data on observed cases: 18 patients from ETN 25 mg BW (week 4) and 17 patients from ETN 50 mg QW (week 12).|||ug*Day/mL||Standard Deviation|Mean
1262303|NCT00418717|Primary|Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.|DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12).|weeks 4 and 12|The analysis population was modified intent to treat (mITT), which included all patients who completed the 25 mg BW dose treatment period and received at least 1 dose of 50 mg OW. Data on observed cases: 41 patients from ENT 25 mg BW (week 4) and 39 patients from ETN 50 mg OW (week 12).|||units on scale||Standard Deviation|Mean
1262304|NCT00418691|Primary|Patient Cognitive Test Scores at End of Treatment Period|For cognitive assessment, set of widely used standardized psychometric instruments shown to be sensitive to neurotoxic effects of cancer treatment. Measures assess attention span (Digit Span), graphomotor speed (Digit Symbol), memory (Hopkins Verbal Memory Test-Revised), verbal fluency (Controlled Oral Words Association), visual motor scanning speed (Trail Making Test Part A), executive function (Trail Making Test Part B); motor speed and dexterity (Grooved Pegboard).|Baseline to end of Week 4 treatment period|||||||
1262305|NCT00418691|Primary|Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score|'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow “trail” made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean).|Baseline to 4-5 weeks on study medication|Analysis were per protocol. The z-score reflects how many standard deviations above or below the population mean a raw score is for each participant.|||z-scores||Standard Deviation|Mean
1262306|NCT00418665|Secondary|Platelet Transfusion|Occurrence of one or more platelet transfusions during the treatment period|Treatment period (up to 16 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
1262405|NCT00418015|Primary|Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention|Visual analog pain scale (0 to 100) at 1st request for supplemental analgesia|VAS at analgesia request|Analysis population per protocol.|||Units on a scale||Inter-Quartile Range|Median
1262307|NCT00418665|Secondary|Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines|CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.|Treatment period and post-treatment follow-up (up to 21 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
1262308|NCT00418665|Secondary|Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia|Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia|Treatment period (up to 16 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
1262309|NCT00418665|Primary|Occurrence of a Clinically Significant Thrombocytopenic Event|Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.|Treatment period through interim follow-up visit (up to 16 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
1262310|NCT00418574|Secondary|Time Course of Immunoresponse|Time course of immunologic parameters (anti-anti-idiotypic antibody - Ab3) will be assessed in all patients, by comparing levels at baseline (week 0), at week 10 after first dose administration and at end of treatment (at week 4 or week 12 after the last administered dose, as appropriate).|at baseline, at week 10 after first dose administration and at final study visit (at week 4 or week 12 after the last administered dose, as appropriate)|Participants who received abagovomab (evaluable population)and have baseline serum sample: 576 at baseline; 538 at week 10 after first dose intake; 449 at the final study visit|||ng/ml||Full Range|Median
1262311|NCT00418574|Secondary|Safety|"Safety was analyzed in all patients who received at least 1 dose administration.~Adverse event (AE) are defined as events which started on or after the first dose of study medication and on or before the date of the final study visit, or within 12 weeks of the last dose if the final study visit was not performed."|Along treatment administration and up to double blind observation period. i.e. for each patient after the first dose administration till the f inal study visit, or within 12 weeks of the last dose|Safety population (i.e. All randomized patients who received at least one dose treatment administration)|||participants|||Number
1262312|NCT00418574|Secondary|Overall Survival|2 years survival rate|2 years|intention to treat (ITT) population (i.e. all randomized patients)|||Percentage of participants|||Number
1262313|NCT00418574|Primary|Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)|The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.|Every 12 weeks up to recurrence or up to 3 months after last administered dose|intention to treat (ITT) population (i.e. all randomized patients)|||days||95% Confidence Interval|Median
1262314|NCT00418561|Other Pre-specified|Physical Examination Results|Physical examination included general appearance, skin, head, ears, eyes, nose and throat, lymph nodes, heart, lungs, abdomen, extremities/joints, hip, neurological, mental status and, if appropriate, breasts, external genitalia, pelvic and rectal, and in addition weight, height and head circumference were recorded.|Baseline up to Week 26|Physical examination results were not summarized since data were collected in participant’s listing only as planned.||||||
1262315|NCT00418561|Primary|Arylsulfatase A (ASA) Activity in Leukocytes||Pre-dose and post-dose at 24 hours on Day 0 and at Weeks 8 and 26|Data were not available to report as ASA activity in leukocytes was presented graphically, as per planned analysis.||||||
1262316|NCT00418561|Primary|Maximum Plasma Drug Concentration (Cmax) of Recombinant Human Arylsulphatase A (rhASA)||Pre-dose and post-dose at 20, 40, 90 minutes, 3, 6 and 8 hours on Day 0, 40 minutes post-dose at Week 4, Pre-dose and post-dose at 20, 40, 90 minutes, 3, 6 and 8 hours at Week 8|Due to quick disappearance of rhASA from plasma, rhASA levels were not possible to report.||||||
1262317|NCT00418561|Other Pre-specified|Change From Baseline in Amplitude at Week 26|Abbreviations: MN=Median Nerve; PN=Peroneal Nerve; SN=Sural Nerve; Dig.=Digit; APB=abductor pollicis brevis; EDB=extensor digitorum brevis.|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||millivolts||Standard Deviation|Mean
1262318|NCT00418561|Other Pre-specified|Change From Baseline in Neurofilament Proteins (NFP), Glial Fibrillary Acidic Protein (GFAP) and Tauprotein in Cerebrospinal Fluid (CSF) at Week 26||Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||nanogram/milliliter||Standard Deviation|Mean
1262319|NCT00418561|Other Pre-specified|Change From Baseline in Chitotriosidase at Week 26||Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||nanomole/hour/milliliter||Standard Deviation|Mean
1262320|NCT00418561|Other Pre-specified|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings|Abnormal ECG findings were considered as clinically significant at the discretion of investigator.|Baseline up to Week 26|ITT|||participants|||Number
1262321|NCT00418561|Other Pre-specified|Number of Participants With Abnormal Findings in Urine Analysis|The parameters analyzed in urine were albumin/protein, glucose, leucocytes, acetoacetate/ketones, nitrite and pH. Urine analysis findings were considered abnormal as judged by the investigator.|Baseline up to Week 26|ITT|||participants|||Number
1262322|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Hematology|"Number of participants with at least 1 shift from baseline to Week 26 are reported.~Abbreviations: Abs=Absolute count; ERCS=Erythrocytes; MCHC=Mean corpuscular hemoglobin concentration; MCH=Mean cell hemoglobin."|Baseline up to Week 26|"ITT. The number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome. Here, N signifies the number of participants who were evaluable for the respective category."|||participants|||Number
1262406|NCT00418015|Secondary|Subjects With Pruritus at 24 Hours Post Morphine|Subjects reporting pruritus in the first 24 hours post cesarean delivery|24 hours post cesarean delivery||||participants|||Number
1262323|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Genotyping|"Number of participants with at least 1 shift from baseline to Week 26 are reported.~Abbreviations: CSF=Cerebrospinal fluid; NFP=Neurofilament proteins."|Baseline up to Week 26|"ITT. The number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome. Here, N signifies the number of participants who were evaluable for the respective category."|||participants|||Number
1262324|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Coagulation|Number of participants with at least 1 shift from baseline to Week 26 are reported. The shift reported below for Cohort 1 was from low level at baseline to low level at Week 26.|Baseline up to Week 26|ITT. Data for Cohorts 2 and 3 were not reported since there were no participants with shift from baseline to Week 26 in coagulation evaluations.|||participants|||Number
1262325|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Biochemistry|"Number of participants with at least 1 shift from baseline to Week 26, are reported.~Abbreviations: ALT=Alanine transaminase; CK=Creatine kinase; AP=Amyloid P component; LDH=Lactate dehydrogenase."|Baseline up to Week 26|ITT. Here, number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome.|||participants|||Number
1262326|NCT00418561|Secondary|Change From Baseline in Paediatric Evaluation of Disability Inventory (PEDI) Scores at Week 26|PEDI is used for the clinical evaluation of functional capabilities, performance and changes in functional skills in children with disabilities. It consisted of 20 items scored on a scale from 0 (total assistance) to 5 (independent). Total score ranged from 0-100 with higher scores indicating better functioning. None, child, rehab, extensive are items in 3 domains (self-care, mobility and social functioning).|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||units on a scale||Standard Deviation|Mean
1262327|NCT00418561|Secondary|Number of Participants With Shift From Baseline to Week 26 in Magnetic Resonance Imaging (MRI)-Loes Scores|Loes scoring system is used to grade the demyelinating abnormalities on brain MRI. A total of 17 locations of the brain were scored from 0 (normal appearance) to 2 (dense appearance). The total score ranged from 0 to 34 with a score of 14 or greater being considered severe. Number of participants with any shift of score between 0 to 2 for each of the 17 locations (Parieto Occipital [PO]-Periventricular [P], Central [C], Subcortical [Sc]; Anterior Temporal [AT]-P, C, Sc; Frontal [F]-P, C, Sc; Corpus Callosum [CC]-Splenium [S], Genus [G]; Projection Fibers [PF]-Capsular interna [CI] ant, CI post, Brainstem [B]; Cerebellum [Cb]-Cortex, Atrophy; Basal Ganglia [BG]-BG, Thalamus [T]; Cerebral Atrophy [CA]-CA), are only reported.|Baseline up to Week 26|ITT. Here, number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome.|||participants|||Number
1262328|NCT00418561|Secondary|Number of Participants Who Had Undergone Nerve Biopsy and Had a Normal Nerve at Both Baseline and Week 26||Baseline, Week 26|ITT.|||participants|||Number
1262329|NCT00418561|Secondary|Change From Baseline in Nerve Conduction Velocity at Week 26|"An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction and units are expressed in meters per second.~Abbreviations: MN=Median Nerve; PN=Peroneal Nerve; SN=Sural Nerve; Dig.=Digit; FH=fibular hemimelia; L LM=left lateral medial; R LM=right lateral medial; MC=medial collateral."|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||meters per second||Standard Deviation|Mean
1262330|NCT00418561|Primary|Change From Baseline in Mullen’s Scales of Early Learning at Week 26|Mullen's Scales of Early Learning is used to assess performance and learning ability in young children. The scale consisted of 144 items that had specific scoring criteria for each item. The scores were converted to T-scores with a decrease in score indicating worsening of disease. Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT|||percent (%) change||95% Confidence Interval|Mean
1262331|NCT00418561|Primary|Number of Participants With Shift From Baseline to Week 26 in Sulfatide Levels in Urine|Number of participants with shifts between negative (value=0) and positive (value=1) values in urine sulfatide levels from baseline at Week 26 is reported.|Baseline up to Week 26|ITT. Here, the number of participants analyzed are the participants evaluable for this outcome.|||participants|||Number
1262332|NCT00418561|Primary|Change From Baseline in Cerebrospinal Fluid (CSF) Sulfatide at Week 26|Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT|||percent (%) change||95% Confidence Interval|Mean
1262333|NCT00418561|Primary|Change From Baseline in Gross Motor Function Measure (GMFM) at Week 26|GMFM was measured using GMFM-88 item scores and summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) and 264 (maximum). The decrease in GMFM score over time indicates worsening of disease over time. Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT|||percent (%) change||95% Confidence Interval|Mean
1262334|NCT00418561|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant, participating in a clinical study with study drug, regardless of causal relationship. TEAEs were AEs occurred after study drug administration that were absent before treatment or that worsened relative to pre-treatment state, up to Week 28 until evaluation (when last cohort had 26-week evaluation and data management performed within 4 weeks) completed.|From study drug administration up to Week 28|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.|||participants|||Number
1262335|NCT00418522|Other Pre-specified|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS|HbA1c lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Using the FAS yielded supplemental analyses for the primary efficacy endpoint.|||percent||Standard Deviation|Mean
1262336|NCT00418522|Secondary|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire|Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed.|Baseline, Week 26|||||||
1262337|NCT00418522|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 26|BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with BMI measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.|||kg/m2||Standard Deviation|Mean
1262338|NCT00418522|Secondary|Change From Baseline in Body Weight at Week 26|Body weight value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with body weight measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.|||kg||Standard Deviation|Mean
1262339|NCT00418522|Secondary|Number of Nocturnal Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug.|||events|||Number
1262340|NCT00418522|Secondary|Crude Hypoglycemic Event Rate|crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.|||events / subject-months|||Number
1262341|NCT00418522|Secondary|Number of Total Subject Months of Treatment|Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.|||subject months|||Number
1262342|NCT00418522|Secondary|Number of Total Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.|||events|||Number
1262343|NCT00418522|Secondary|Number of Subjects With Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.|||participants|||Number
1262344|NCT00418522|Secondary|Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26|SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.|||mg/dL||Standard Deviation|Mean
1262345|NCT00418522|Secondary|Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26|24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.|||mg/dL||Standard Deviation|Mean
1262346|NCT00418522|Secondary|Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26|CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (adiponectin and ApoB) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/mL||Standard Deviation|Mean
1262347|NCT00418522|Secondary|Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26|CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (hs-CRP, leptin, and spot urine microalbumin) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/L||Standard Deviation|Mean
1262348|NCT00418522|Secondary|Change From Baseline in Lipids at Week 26|Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with lipids data at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/dL||Standard Deviation|Mean
1262349|NCT00418522|Secondary|Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26|Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS = all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with postprandial blood glucose measurements as measured by 8-point profiles at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/dL||Standard Deviation|Mean
1262350|NCT00418522|Secondary|Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26|Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting and postprandial blood glucose measurements determined by standardized meal tolerance tests at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/dL||Standard Deviation|Mean
1262351|NCT00418522|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 26|Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting plasma glucose at Baseline and Week 26: inhaled human insulin n=202, insulin glargine n=189.|||mg/dL||Standard Deviation|Mean
1262352|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26|Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 8.0% at Week 26: inhaled human insulin n=162, insulin glargine n=158.|||percentage of participants|||Number
1262353|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26|Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 7.0% at Week 26: inhaled human insulin n=127, insulin glargine n=90.|||percentage of participants|||Number
1262354|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26|Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 6.5% at Week 26: inhaled human insulin n=72, insulin glargine n=42.|||percentage of participants|||Number
1262355|NCT00418522|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population|HbA1c lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|Per protocol (PP)=Full Analysis Set (FAS) subjects (i.e., had >=1 study drug dose and >=1 post-baseline measurement) with >=12 weeks treatment and no major protocol violation. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c values at Baseline and Week 26: inhaled human insulin n=154, insulin glargine n=157.|||percent||Standard Deviation|Mean
1262356|NCT00418379|Primary|Average Adjusted Symptom Score (AAdSS)|"The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.~Participants assessed daily, during the Year 3 pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome."|Pollen period (average of 33.8 days) of Year 3|Full Analysis Set Year 3 (FASY3). FASY3 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (AdSS) during the pollen period while on treatment during the Year 3.|||Units on a scale (range: 0 to 18)||Standard Error|Least Squares Mean
1262357|NCT00418314|Secondary|All Cause, Cardiovascular and Heart Failure Hospitalization||12 months||||participants|||Number
1262358|NCT00418314|Secondary|All-cause, Cardiovascular and Heart Failure Mortality;||12 months|Per protocol|||participants|||Number
1262359|NCT00418314|Primary|Heart Failure Clinical Composite Score|The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse.|12 months||||participants|||Number
1262360|NCT00418262|Secondary|Compare Growth While on Atomoxetine With Growth Before Entry Into Study.|Height measured in centimeters at the time of each visit as part of the vital signs.|12 months or study duration|Measurements of height were not consistently obtained on all subjects.|||cm||Standard Deviation|Mean
1262407|NCT00418015|Secondary|Severity of Pruritus Following Fentanyl|Severity of pruritus during labor analgesia|Labor analgesia||||participants|||Number
1262361|NCT00418262|Secondary|Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.|Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.|12 months or study duration|ADHD Parent Rating Scale|||units on a scale||95% Confidence Interval|Mean
1262362|NCT00418262|Primary|Pittsburg Side-Effects Scale: Trouble Sleeping|Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.|12 months or study duration|One subject participating in the RCT did not participate in the open label|||units on a scale||Standard Deviation|Mean
1262363|NCT00418262|Primary|Pittsburg Side-Effects Scale: Loss of Appetite|"Loss of Appetite~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
1262364|NCT00418262|Primary|Pittsburg Side-Effects Scale: Hallucinations|"Hallucinations~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
1262365|NCT00418262|Primary|Pittsburg Side-Effects Scale: Socially Withdrawn|"Socially Withdrawn~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
1262366|NCT00418262|Primary|Pittsburg Side-Effects Scale: Tearful/Sad/Depressed|"Tearful/Sad/Depressed~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in RCT did not participate in the open label study|||units on a scale||Standard Deviation|Mean
1262367|NCT00418262|Primary|Pittsburg Side-Effects Scale: Crabby/Irritable|"Crabby/Irritable~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One Subject in the RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
1262368|NCT00418262|Primary|Pittsburg Side-Effects Scale: Stomachaches|"Stomachaches~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the Open Label Study|||units on a scale||Standard Deviation|Mean
1262369|NCT00418262|Primary|Pittsburg Side-Effects Scale: Headaches|"Headaches~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from the RCT did not enter the open label study|||units on a scale||Standard Deviation|Mean
1262370|NCT00418262|Primary|Pittsburg Side-Effects Scale: Dull/Tired/Listless|"Dull/Tired/Listless~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from the RCT did not enter the open label study|||units on a scale||Standard Deviation|Mean
1262371|NCT00418262|Primary|Pittsburg Side-Effects Scale: Worried/Anxious|"Worried/Anxious~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
1262372|NCT00418262|Primary|Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers|"Movements, Picking/Chewing Skin or Fingers~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|27 IN PCT and one subject did not enroll in the safety efficacy study|||units on a scale||Standard Deviation|Mean
1262373|NCT00418262|Primary|Pittsburg Side-Effects Scale-Buccal, Lingual Movements|"Buccal, Lingual Movements~Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation."|12 months or study duration|Attrition|||units on a scale||Standard Deviation|Mean
1262374|NCT00418262|Primary|Pittsburg Side-Effects Scale: Motor Tics|"Motor Tics~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|Children with FAS participating in the extend safety efficacy study|||units on a scale||Standard Deviation|Mean
1262375|NCT00418184|Secondary|Lipid Profile (Cholesterol, HDL, Triglycerides)||on weeks 0,15|||||||
1262376|NCT00418184|Secondary|Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca||on weeks 0,15|||||||
1262377|NCT00418184|Secondary|Complete Blood Counts||on weeks 0,15|||||||
1262378|NCT00418184|Secondary|Barkley Side Effects Rating Scale (SERS)||on weeks 0,15|||||||
1262379|NCT00418184|Secondary|Essential Fatty Acid (EFA)-Deficiency Symptoms||on weeks 0,15|||||||
1262380|NCT00418184|Secondary|Vital Signs||on weeks 0,15|||||||
1262381|NCT00418184|Secondary|Blood Monoamines Metabolism||on week 0, 15|||||||
1262382|NCT00418184|Secondary|Plasma and Red Blood Cells Fatty Acid Profile||on weeks 0,15|||||||
1262383|NCT00418184|Secondary|Child Health Questionnaire (CHQ)- Parent-completed Form 50||on weeks 0,15|||||||
1262384|NCT00418184|Secondary|Test of Variables of Attention (TOVA)||on weeks 0,15|||||||
1262385|NCT00418184|Secondary|Clinical Global Impression of Improvement||on weeks 0,15|||||||
1262386|NCT00418184|Secondary|Strength and Difficulties Questionnaires - Home Version||on weeks 0,15|||||||
1262387|NCT00418184|Secondary|Strength and Difficulties Questionnaires - School Version||on weeks 0,15|||||||
1262388|NCT00418184|Secondary|Conners Rating Scale - Home Version|A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on the childs home behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.|change from baseline in conners raiting scale at 15 weeks|The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.|||Scores on a scale||Standard Error|Mean
1263975|NCT00406315|Secondary|Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16|HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||mg/dL||Standard Deviation|Mean
1262389|NCT00418184|Primary|Conners Rating Scale - School Version|A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.|change from baseline in conners raiting scale at 15 weeks|The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.|||Scores on a scale||Standard Error|Mean
1262390|NCT00418145|Secondary|Improvement Using Targeted Neurological Deficits (TND).||Day 28 and day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.||||||
1262391|NCT00418145|Secondary|Frequency of Relapse Over Time (up to One Year) When Subjects With Relapsing Forms of MS Are Administered One Course of Oral Methylprednisolone Compared to IV Administration.||Day 28 and day 90 and day 365|Data is also no longer accessible. Data was with biostatistician who no longer has data.||||||
1262392|NCT00418145|Secondary|Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.||Day 28 and day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.||||||
1262393|NCT00418145|Primary|Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.|There is no data analysis for this study|Day 28 and Day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.||||||
1262394|NCT00418093|Secondary|Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.|The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported|Toxicities were assessed every cycle and for up to 30 days after being removed from the trial|All patients enrolled|||percentage of participants|||Number
1262395|NCT00418093|Secondary|Overall Survival|Duration of time participants are alive after enrolling on the study. Assessed by clinical records|Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months|All patients enrolled|||weeks||95% Confidence Interval|Median
1262396|NCT00418093|Secondary|Progression Free Survival|Time participant remains free of progression of her disease. Evaluated by RECIST criteria|Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months|19|||weeks||95% Confidence Interval|Median
1262397|NCT00418093|Primary|Partial Response Rate|Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria|Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)||||percentage of patients on study|||Number
1262398|NCT00418028|Secondary|Progression Free Survival|Progresion Free Survival is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies for any reason.|Time (in months) from the moment the patient starts the study treatment to the date of progressive disease.||||Months||95% Confidence Interval|Median
1262399|NCT00418028|Secondary|Clinical Benefit|"A patient experiences a Clinical Benefit if the following is satisfied:~Criterion: The patient has “Complete response”, “Partial Response” or “Stable Disease” and it continues during more than 3 months."|Months from “CR”,“PR” or “SD” (the first one) until Progression date, new treatment or last contact date.|Only 179 patients had tumor evaluation data.|||Participants|||Count of Participants
1262400|NCT00418028|Secondary|Overall Survival|An event is defined as death. A patient is censored if she does not die. The censoring date is last contact date.|Time to survival is the number of months from the study treatment start date to the date of death.||||Months||95% Confidence Interval|Median
1262401|NCT00418028|Secondary|Time to Treatment Failure|"Time to treatment failure (TTF) is defined as the time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient’s decision or investigator criteria.~If a patient did not end the treatment, it is censored. The censoring date is the date of the last dose received."|Time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient’s decision or investigator criteria.|This outcome only was analyzed in the Per Protocol Population (182 patients).|||Months||95% Confidence Interval|Median
1262402|NCT00418028|Secondary|Response Duration|"Response duration is computed for all patients with Partial Response or Complete Response, during the treatment period, as the time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first.~A patient is censored if she does not progress or die. In these cases Response duration is computed as the time from the moment the Partial or Complete Response is reported to the last contact date."|Time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first.|From 192 patients (95 in Arm A and 97 in Arm B), 61 patients had Complete Response or Partial Response (30 in Arm A and 31 in Arm B).|||Months||95% Confidence Interval|Median
1262403|NCT00418028|Secondary|Response Rate|Response was evaluated using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|Every 3 cycles and at the end of chemotherapy|There were 95 patients in Arm A and 97 patients in Arm B. There were 13 patients without response evaluation (9 in Arm A and 4 in Arm B).|||Participants|||Count of Participants
1262404|NCT00418028|Primary|Time to Progression|Time to Progresion (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|After 1 year from the treatment start day.|A total of 192 patients (95 in Arm A and 97 in Arm B) were considered for this analysis but 36 were censored (23 in Arm A and 13 in Arm B). Patients censored are those that did not progress or die due to progressive disease during the study treatment.|||months||95% Confidence Interval|Median
1288247|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42||Month 42||||L||Standard Error|Mean
1262410|NCT00417989|Secondary|Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy|Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 Weeks||||participants||Standard Deviation|Mean
1262411|NCT00417989|Secondary|Quality of Life - Short Form-36 (SF-36v2™), General Health|Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 Weeks|Adult population (18 and older) only|||Participants||Standard Deviation|Mean
1262412|NCT00417989|Secondary|Health Economic Outcome|Health Economic Outcome was a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors. This analysis was restricted to only adult subjects (Age 19 to 70), therefore the number of participant analyzed is different. The goal was to estimate the long term cost effectiveness of Sensor Augmented Pump therapy from the perspective of the US health care system. The unit of measurement was cost in $ per year for sensor augmented pump group and MDI group. No formal statistical analysis was planned or performed|Baseline and 52 weeks||||$|||Number
1262413|NCT00417989|Secondary|Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score|Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 weeks|Adult population (18 and older) only|||participants||Standard Deviation|Mean
1262414|NCT00417989|Secondary|Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52|Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 52.|Baseline and 52 weeks||||mmol/dl*min||Standard Deviation|Mean
1262415|NCT00417989|Secondary|Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;|Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 52.|Baseline and 52 weeks||||mmol/dl*min||Standard Deviation|Mean
1262416|NCT00417989|Secondary|Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52|Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.|Baseline and 52 weeks||||participants|||Number
1262417|NCT00417989|Secondary|Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;|Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.|Baseline and 52 weeks||||number of events|||Number
1262418|NCT00417989|Primary|Change in A1c From Baseline to 52 Weeks|Change is defined as A1c at Week 52 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.|Baseline and 52 weeks||||Percent glycated hemoglobin||Standard Deviation|Mean
1262419|NCT00417976|Secondary|Response Rates Defined by RECIST 1.0|The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients|6 months||||patients|||Number
1262420|NCT00417976|Primary|Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy||6 months||||percent of patients|||Number
1262421|NCT00417963|Secondary|Number of Participants Experiencing Restenosis|Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.|12 months after implantation|Number of participants experiencing restenosis through 12 months from implantation.|||number of participants|||Number
1262422|NCT00417963|Secondary|Number of Participants Experiencing Lesion Success|number of participants experiencing achievement of <50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System.|at time of implantation|number of participants with lesion success defined as <50% residual stenosis.|||number of participants|||Number
1262423|NCT00417963|Secondary|Number of Participants Experiencing Device Success|Number of participants with successful delivery and deployment of device with <50% residual stenosis.|at time of implantation|Number of participants with successful delivery and deployment of device with <50% residual stenosis.|||number of participants|||Number
1262424|NCT00417963|Secondary|Number of Participants Experiencing Stroke Related Neurologic Deficit|Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.|30 days from implantation|Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to index procedure.|||number of participants|||Number
1262425|NCT00417963|Secondary|Number of Patients Experiencing Access Site Complications|Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.|30 days following implantation|Number of participants experiencing access site complications requiring blood transfusion (>1 unit) or open repair.|||Number of participants|||Number
1262426|NCT00417963|Secondary|Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)|Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation|12 months from implantation|Number of participants experiencing target lesion revascularization up to 12 months from implantation|||Number of participants|||Number
1262427|NCT00417963|Primary|Percentage of Patients Experiencing Major Adverse Events (MAE)|A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.|365 days from implantation|All patients who were enrolled in the pivotal cohort were analyzed as an intention to treat population.|||percentage of participants||95% Confidence Interval|Mean
1262428|NCT00417885|Secondary|Clinical Benefit Rate (CBR)|The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response.|From start of treatment until Day 1 of every other cycle (8 weeks)|ITT. Data were not analyzed due to early termination.|||rate|||Number
1262429|NCT00417885|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks)|ITT. Data were not analyzed due to early termination.|||weeks||Standard Deviation|Mean
1262430|NCT00417885|Secondary|Overall Survival (OS)|OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7.|From start of study treatment until death|ITT. Data were not analyzed due to early termination.|||weeks||Standard Deviation|Mean
1262431|NCT00417885|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer|Analyses on DR were to be performed for overall responders only. Data were not analyzed due to early termination.|||weeks||Standard Deviation|Mean
1262432|NCT00417885|Secondary|Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 1 of every other cycle (8 weeks)|Analyses on OR were performed for subjects who received at least 1 dose of study medication.|||participants|||Number
1262433|NCT00417885|Primary|Progression Free Survival (PFS)|PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date – the date of enrollment +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks) or death|Intent-To-Treat (ITT) = all subjects who were enrolled in the trial. Data were not analyzed due to early termination.|||weeks||Standard Deviation|Mean
1262434|NCT00417612|Primary|Reduction of Parathyroid Hormone Area Under the Curve (PTHauc) of 20% or Greater|Clinically significant reduction of Mean PTHauc (% decrease >/= 20) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12.|Measured at baseline and Month 12||||percentage of participants|||Number
1262435|NCT00417612|Primary|Area Under the Curve for Parathyroid Hormone (PTH; Percentage Decrease)|Mean PTHauc (% decrease) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12.|Measured at baseline and Month 12||||participants|||Number
1262436|NCT00417612|Secondary|Serum 1,25 (OH)2D||Measured at baseline and Month 12||||pg/ml||Standard Deviation|Mean
1262437|NCT00417612|Secondary|Serum Intact Fibroblast Growth Factor 23 (FGF23)||Measured at baseline and Month 12||||pg/ml||95% Confidence Interval|Mean
1262438|NCT00417612|Secondary|Percent Change in Urinary Calcium Excretion From Baseline to 1 Year|Percent change in daily urinary calcium excretion, which is calculated the measurements of the calcium in the subject's 24-hr urine collections done at baseline and at the 1 year timepoints|Measured at baseline and Month 12||||percent change||Standard Deviation|Mean
1262439|NCT00417612|Secondary|Bone Scan Severity Score|"99-Tc-methylenediphosphonate bone scans were completed and analyzed using the following scale*: Bone scan severity scale with minimum score of 0 and maximum score of 4 (0 is no disease and 4 is greatest severity of disease).~Appearance of lumbar spine and the sacroiliac region were used as internal references to which all suspected lesions were compared, and scored as follows:~grade 0, normal scan without suspicious lesions grade 1, lesion(s) less intense than normal lumbar spine grade 2, lesion(s) similar in intensity to normal lumbar spine grade 3, lesions more intense than normal lumbar spine but similar to the normal sacroiliac region grade 4, lesions more intense than the normal sacroiliac region.~*devised by nuclear medicine radiologist at Yale New Haven Hospital"|Measured at baseline and Month 12||||units on a scale||Standard Deviation|Mean
1262440|NCT00417612|Secondary|Serum Calcium||Measured at baseline and Month 12||||mg/dl||Standard Deviation|Mean
1262441|NCT00417612|Secondary|Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms.||Measured at baseline and Month 12|Alkaline phosphatase activity was analyzed separately for children (less than 18 years of age) and adults as values varied considerably between these two groups. In other outcome measure modules the paricalcitol group is comprised of 19 participants analyzed which includes adults and children. In this module, the children (2) are their own arm.|||mg/dl||Standard Deviation|Mean
1262442|NCT00417612|Primary|Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement|Mean area under the curve for parathyroid hormone levels (PTHauc) sampled during a 26 hour study period, for Paricalcitol (Active Drug) and Placebo groups at Baseline and Month 12 .|Measured at baseline and Month 12||||nlEq*26hr/ml||Standard Deviation|Mean
1263161|NCT00411398|Primary|Hamilton Anxiety Scale|Standard Clinical Depression Rating Scale. Clinician administered. Scale units are points/numbers. Possible range is 0 to 44 with the latter signifying more severe anxiety|10 wk|LOCF if at least one post baseline visit completed|||units on a scale||Standard Deviation|Mean
1262443|NCT00417482|Secondary|Weight|For each subject, the change in weight in pounds between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in weight over time.|Phase B, weeks 1-16 (study weeks 16-32)|Available data from all randomized subject (N=110) was used in this analysis. Weight measurements were unavailable at one or more time points for 3 subjects in the placebo group and for 6 subjects in the risperidone group.|||pounds||Standard Deviation|Mean
1262444|NCT00417482|Secondary|Physical Self-Maintenance Scale (PSMS)|Physical Self-Maintenance Scale, which ranges from 1 to 30, with higher scores indicating WORSE functioning. For each subject, the change in PSMS between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in PSMS (worse functioning) over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis, with the exception of one placebo subject for whom PSMS data was not available at one time point|||units on a scale||Standard Deviation|Mean
1262445|NCT00417482|Secondary|AIMS|The Abnormal Involuntary Movement Scale (AIMS) assesses signs of tardive dyskinesia, a movement disorder that can occur with prolonged use of antipsychotic medication. The AIMS score ranges from 0 to 35, with higher scores indicating more severe symptoms. For each subject, the change in AIMS score between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in AIMS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis (N=110).|||units on a scale||Standard Deviation|Mean
1262446|NCT00417482|Secondary|Extrapyramidal Signs (EPS)|Extrapyramidal signs, also known as Parkinsonian signs, refer to signs of tremor, rigidity, and bradykinesia (slowed movement) that are seen in Parkinson's disease. Assessment of extrapyramidal signs (EPS) were made with the use of the Simpson-Angus scale (which ranges from 1-40) with higher scores indicating more extrapyramidal signs. For each subject, the change in EPS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in EPS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in the analysis (N=110).|||units on a scale||Standard Deviation|Mean
1262447|NCT00417482|Secondary|Treatment Emergent Symptoms Scale (TESS)|The Treatment Emergent Symptom Scale (TESS) assesses 26 somatic symptoms. Total scores range from 0-26, with a score of 0 or 1 for each item. Higher scores indicate more somatic symptoms. For each subject, the change in TESS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in TESS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis (N=110)|||units on a scale||Standard Deviation|Mean
1262448|NCT00417482|Secondary|Mini Mental State Exam (MMSE)|The MMSE assesses cognition. Scores range from 0-30, with higher scores indicating better cognition. For each subject, the change in MMSE between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in MMSE over time.|Phase B, weeks 1-16 (study weeks 16-32)|MMSE data were missing for 2 subjects in the placebo group and 1 subject in the risperidone group, so the number of subjects in this analysis were 38 (placebo) and 69 (risperidone), for a total of 107.|||units on a scale||Standard Deviation|Mean
1262449|NCT00417482|Secondary|Relapse by Study Week 48|Same definition and criteria as the primary outcome|16-32 weeks in Phase B (32-48 weeks in study)|Randomized subjects in each Arm who had not relapsed or terminated the study by the end of the first 16 weeks of Phase B were analyzed in the second 16 weeks of Phase B using intent to treat (ITT) principles.|||participants|||Number
1262450|NCT00417482|Primary|Relapse by Study Week 32|"A relapse occurred in Phase B (post-randomization) if both of the following criteria were met:~Increase in the Neuropsychiatric Inventory (NPI) core score of 30% or more OR a 5-point increase from the baseline NPI score at the end of Phase A~A score of 6 (much worse) or 7 (very much worse) on the Clinical Global Impression-Change (CGI-C) at any visit."|0-16 weeks in Phase B (16-32 weeks in study)|Analysis was performed as per intention to treat (ITT) principles.|||participants|||Number
1262451|NCT00417417|Other Pre-specified|Brachial Artery Flow-mediated Dilation|Brachial artery flow-mediated dilation in respone to 5 minutes of forearm ischemia|Two weeks following final administration of drug|Per protocol|||percent change||Standard Deviation|Mean
1262452|NCT00417417|Primary|C-Reactive Protein (CRP)|C-reactive protein levels in subjects randomized to rilonacept versus placebo injections.|2 wks following last drug administration|per protocol|||mg/L||Standard Deviation|Mean
1262453|NCT00417274|Primary|Efficacy of Quinacrine, Based on Prostate Specific Antigen (PSA) Response in Patients With Androgen-independent Metastatic Prostate Cancer|Patients who achieved a complete response (CR) or a partial response (PR) to therapy were allowed to continue to receive treatment until disease progression or unacceptable toxicity occurred, until the patient discontinued treatment for another reason, or for a total of 6 months. Patients who continued to show a CR or PR or who maintained stable disease (SD) after 6 months of therapy were to be allowed to continue therapy at the investigator’s discretion.|End of treatment|Based on clinical judgment|||Participants|||Number
1262454|NCT00417248|Secondary|Overall Survival||18 months|Data for this outcome measure was not collected or analyzed due to the early termination of the study.||||||
1262455|NCT00417248|Primary|Time to Disease Progression (TTP)||18 months|The primary objective for this study was not analyzed due to termination of the study. No participants were on-study for a sufficient period of time to collect or analyze the time to disease progression data.||||||
1262456|NCT00417170|Secondary|Mean Change in Arterial Compliance as Measured by Pulse Wave Analysis From Baseline and After 12 Weeks of Treatment|Arterial Compliance is determined by Pulse Wave Analysis measured by a detector placed at the carotid artery while taking ECG and tonometry at the same time. Procedure is repeated for the femoral artery. Pulse Wave data are calculated by dividing distance between 2 arteries by the difference between the rise delay of the distal pulse wave and the R wave of the QRS complex and the rise delay of the proximal pulse wave to the QRS complex. Data analysis used an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1269967|NCT00360334|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
1262457|NCT00417170|Secondary|Mean Change From Baseline in Inflammatory Marker ( C-peptide) as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment [Time Frame: At Baseline and After 12 Weeks of Treatment|C-peptide level is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor.|Baseline and after 12 weeks of treatment|The PD analysis set included all subjects with available PD data and no major protocol deviations with impact on PD data. During different time points, participants with observations at that time point were included in the analysis.|||ng/mL||Standard Error|Least Squares Mean
1262458|NCT00417170|Secondary|Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment|Insulin Concentration is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set included all participants with available PD data and no major protocol deviation with impact on PD data. During different time points, participants with observations at that time point were included in the analysis.|||mU/L||Standard Error|Least Squares Mean
1262459|NCT00417170|Secondary|Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment.|Insulin sensitivity is measured by the hyperglycemic euglycemic clamp procedure where a supine patient has 2 IV lines inserted for sampling blood. Regular human insulin (60mU/m^2 surface area/min) is infused for 120 minutes. Dextrose (20% w/v) is infused to maintain glycemia at < 100 mg/dL and is adjusted based on plasma glucose levels obtained every 5 minutes. Blood for glucose and insulin is taken at specified time intervals. Change from baseline data is analyzed by analysis of variance model including treatment and week as fixed factors, and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.|||mg/kg/min||Standard Error|Least Squares Mean
1262460|NCT00417170|Primary|Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment|MBF is measured by Positron Emission Tomography (PET) first at rest, then 45 minutes later, during cold pressor testing (CPT). The patient is placed in the PET scanner and injected with N-13 ammonia as a tracer. PET images are taken to assess myocardial blood flow at rest. After 40 minutes, the patient immerses one hand in ice water and PET images are taken to assess myocardial blood flow at sympathetic activation. Change from baseline data is analyzed by an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.|||mL/g/min||Standard Error|Least Squares Mean
1262461|NCT00417079|Secondary|Pain Response|Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.|from baseline up to 104 weeks (study cut-off)|Pain Response (applies only to patients, in the Intention-To-Treat (ITT) population, with median PPI ≥2 on McGill-Melzack scale and/or mean Analgesic Score ≥10 points at baseline)|||Percentage of participants||95% Confidence Interval|Number
1262462|NCT00417079|Secondary|Time to Pain Progression|"Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.~Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)"|from baseline up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. Data from 265 and 279 patients in the cabazitaxel and mitoxantrone groups, respectively, were censored as a results of > 2 PPI and/or AS assessments being missed during the same week (unless a complete evaluation of ≥5 values showed pain progression).|||Months||95% Confidence Interval|Median
1262463|NCT00417079|Secondary|PSA (Prostate-Specific Antigen) Response|PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.|from baseline up to 104 weeks (study cut-off)|Prostate Specific Antigen (PSA) response was evaluated only in patients, in the Intention-To-Treat population, with a baseline PSA >20ng/mL.|||Percentage of participants||95% Confidence Interval|Number
1262464|NCT00417079|Secondary|Time to Prostatic Specific Antigen (PSA) Progression|"In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.~In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later."|at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).|||Months||95% Confidence Interval|Median
1269968|NCT00360334|Secondary|Change in Fasting Serum Total Cholesterol (TC)|Change in TC from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
1262465|NCT00417079|Secondary|Time to Tumor Progression|Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).|||Months||95% Confidence Interval|Median
1262466|NCT00417079|Secondary|Overall Tumor Response|"Tumor Overall Response Rate (ORR) (only in patients with measurable disease):~Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.~Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.~Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response."|From the date of randomization up to 104 weeks (study cut-off)|Tumor response rate was evaluated only for patients, in the Intention-To-Treat (ITT) population, with measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST).|||percentage of participants||95% Confidence Interval|Number
1262467|NCT00417079|Secondary|Time to Progression Free Survival (PFS)|Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).|||Months||95% Confidence Interval|Median
1262468|NCT00417079|Primary|Overall Survival|"Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.~In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first."|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).|||Months||95% Confidence Interval|Median
1262469|NCT00417027|Secondary|Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery.|Patient satisfaction with analgesia management during labor and delivery. Scores are 0 to 100 with 0 complete dissatisfaction and 100 complete satisfaction with labor analgesia.|24 hours following labor analgesia|per protocal|||Scores on a scale (0 toi 100)||Inter-Quartile Range|Median
1262470|NCT00417027|Secondary|Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.|Highest level of sensory loss to ice 3 hours after initiation of epidural analgesia. Thoracic dermatomes specify the level at which the nerves exit the spinal column. Higher thoracic spread of analgesia suggests greater dispersion of the epidural solution and may correlate with better analgesia. Higher levels are given by lower thoracic vertebral number. For example dermatome 4 has greater spread than dermatome 5.|3 hours after initiation of labor analgesia||||participants|||Number
1262471|NCT00417027|Secondary|Manual Bolus Doses Administered||Duration of labor analgesia||||participants|||Number
1262472|NCT00417027|Secondary|Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered|Patient controlled bolus of analgesic solution could be requested by activating a button. Bolus were 5ml of the epidural solution (bupivacaine 6.25mg/ml and fentanyl 1.96mgml). Patient requested administrations were allowed every 10 minutes to a maximum of 30 ml of epidural solution per hour.|Duration of labor analgesia|per protocal|||participants||Inter-Quartile Range|Mean
1262473|NCT00417027|Secondary|Patient Controlled Bolus Attempts|The number of attempted self administered bolus doses of epidural analgesia solution for control of pain.|Duration of labor analgesia|per protocal|||number of bolus attempts||Inter-Quartile Range|Mean
1262474|NCT00417027|Secondary|Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve|The pain burden calculated as the area under the visual analog pain scale (0 to 100 mm) patient self reported assessment of pain. Pain assessment were made at regular intervals during labor and the area under the pain score per time curve was calculated as the pain burden during labor. Greater pain would be indicated by a larger area. Possible range would be 0 for no pain to 100 for severe pain.|Duration of labor analgesia|per protocal|||0 to 100 mm per hour||Inter-Quartile Range|Median
1262475|NCT00417027|Primary|Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.|Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.|From initiation of labor analgesia until delivery less than 24 hours|per protocal|||mg bupivacaine per hour||Inter-Quartile Range|Median
1262476|NCT00416949|Primary|Tumor Absorbed Dose|Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.|up to 4 years|Was only able to analyze tumor data from 3 patients based on number of tumors that could be reliably imaged for analysis.|||Gy|number of tumors|Standard Deviation|Mean
1262477|NCT00416884|Primary|Number of Participants With Treatment-related Mortality|Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding|lifetime followup, up to 100 years.||||Participants|||Number
1262478|NCT00416793|Secondary|Overall Response Rate|Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.|Evaluated at end of every second 3 week cycle for response|||||||
1263162|NCT00411216|Secondary|Eye Movements: Scleral Search Coil|eye movements are measured by having the participant sit within an electromagnetic field while wearing a scleral coil (like a contact lens but only in contact with the sclea, not the cornea); te coil moves with eye movement and distorts the electrimagnetic field|pre- and post-treatment|||||||
1262479|NCT00416793|Primary|Overall Survival Rate at 6 Months|Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.|up to 6 months|Analysis was per protocol; Limited analysis due to study early termination.|||Proportion of participants|||Number
1262480|NCT00416715|Secondary|Letrozole Serum Levels Before and After Vitamin D Repletion|Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.|Baseline and 1 month post vitamin D repletion|Only considering those patients who were baseline vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.|||micro-grams/mL||Inter-Quartile Range|Median
1262481|NCT00416715|Primary|Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness|Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.|Baseline and 1 month post vitamin D repletion||||Participants|||Count of Participants
1262482|NCT00416624|Secondary|Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). Average scores across all time points for each item were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.|||units on a scale||Standard Deviation|Mean
1262483|NCT00416624|Secondary|Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.|||units on a scale||Standard Deviation|Mean
1262484|NCT00416624|Secondary|Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.|||units on a scale||Standard Deviation|Mean
1262485|NCT00416624|Secondary|Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.|||units on a scale||Standard Deviation|Mean
1262486|NCT00416624|Secondary|The Percentage of Participants Reported Grade 3 or 4 Adverse Events|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|16 weeks|All patients that were evaluable per protocol and reported at least one value after baseline.|||percentage of participants|||Number
1262487|NCT00416624|Secondary|The Percentage of Participants With Dose Omitted Due to Hematologic Reason|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 Weeks|All patients that were evaluable per protocol.|||percentage of Participants|||Number
1262488|NCT00416624|Secondary|The Total RBC Transfusion Needed|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had RBC transfusions data.|||g/dL||Standard Deviation|Mean
1262489|NCT00416624|Secondary|The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had RBC transfusions data.|||percentage of participants|||Number
1262490|NCT00416624|Secondary|Mean Hemoglobin Change From Week 1 to Week 16|To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule. The positive numbers represent hemoglobin increases and negative numbers represent hemoglobin decreases.|Week 1 and Week 16|All patients that were evaluable per protocol and had hemoglobin data.|||g/dL||Standard Deviation|Mean
1262491|NCT00416624|Secondary|Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had hemoglobin levels data.|||days||95% Confidence Interval|Median
1262492|NCT00416624|Secondary|Weekly Change in Hemoglobin Levels|To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule|Baseline and Week 4, 7, 10, 13, 16|All patients that were evaluable per protocol and had hemoglobin data at baseline, week 4, 7, 10, 13 or 16.|||g/dL||Standard Deviation|Mean
1262493|NCT00416624|Primary|The Percentage of Participants Who Exhibit a Hematopoietic Response|A hematopoietic response was defined as Hb rise >2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period|20 weeks|All patients that were evaluable per protocol.|||Percentage of participants|||Number
1263163|NCT00411216|Secondary|Fall Risk (Dynamic Gait Index)|performance test|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1262495|NCT00416598|Primary|Disease-free Survival (DFS) Rate at 1 Year|"For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method~A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL)."|At 1 year||||percentage of participants|||Number
1262496|NCT00416598|Primary|Number of Participants Who Completed Maintenance Decitabine.|To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.|Up to 5 years||||participants|||Number
1262497|NCT00416572|Primary|Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)|The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health).|Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.|||units on a scale||Standard Deviation|Mean
1262498|NCT00416572|Primary|Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)|The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health).|Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.|||units on a scale||Standard Deviation|Mean
1262499|NCT00416572|Primary|Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).|Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.|Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.|||units on a scale||Standard Deviation|Mean
1262500|NCT00416520|Secondary|Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)|ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.|week12 minus week0|ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.|||mg / dL||Standard Deviation|Mean
1262501|NCT00416520|Primary|Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)|ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.|week16 minus week12|ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.|||mg / dL||Standard Deviation|Mean
1262502|NCT00416494|Other Pre-specified|Effect on Wound Angiogenesis||After study completion|||||||
1262503|NCT00416494|Other Pre-specified|Effect on Angiogenesis Biomarkers||After study completion|||||||
1262504|NCT00416494|Secondary|Safety and Tolerability|Number of participants with adverse events|After all participants went off study drug regimine.||||participants with adverse event|||Number
1262505|NCT00416494|Secondary|Overall Survival|Average months of survival of participants after receiving study drug.|From time of treatment until death from any cause, assesed up to 60 months.||||months||95% Confidence Interval|Median
1262506|NCT00416494|Secondary|Disease Free Survival|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.||||months||95% Confidence Interval|Median
1262507|NCT00416494|Secondary|Time to Progression|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From time of treatment until documented progression, assesed up to 60 months.||||months||95% Confidence Interval|Median
1262518|NCT00416455|Secondary|Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
1263164|NCT00411216|Secondary|Balance and Gait|gait speed|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1263165|NCT00411216|Secondary|Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium|visual analoque scales|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1262508|NCT00416494|Primary|Response Rate (Percentage of Participants With Partial or Complete Response)|"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.~Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~The definitions were:~Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.|All subjects who had restaging scans were included in the analysis.|||percentage of participants with response||95% Confidence Interval|Number
1262509|NCT00416455|Secondary|Cause of Interruption in Radiation Therapy in Cervical Cancer Patients|Number of cervical cancer patients with reasons of interruption in radiation therapy|Within 6 weeks after surgery|Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy who experienced an interruption in radiation therapy|||Participants|||Count of Participants
1262510|NCT00416455|Secondary|Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients|Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy|Within 4 weeks from PET/CT|All Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy and the reason they experienced a delay in the initiation of chemo-radiation|||Participants|||Count of Participants
1262511|NCT00416455|Secondary|Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy|Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.|During surgery and up to 30 days after surgery.|All loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy|||Participants|||Count of Participants
1262512|NCT00416455|Secondary|Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node||Before surgery (FDG-PET/CT) and after surgery (pathology)|Particpants with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants|||Number
1262513|NCT00416455|Secondary|Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes||Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants|||Number
1262514|NCT00416455|Secondary|Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.|||percentage of participants||95% Confidence Interval|Mean
1262515|NCT00416455|Secondary|Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
1262516|NCT00416455|Secondary|Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
1262517|NCT00416455|Secondary|Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
1262596|NCT00415168|Secondary|Duration of Response|Measured from the time of first documentation of CR or PR (whichever status is first recorded) until the date of time to disease progression.|Time of response to progressive disease up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||months||95% Confidence Interval|Median
1262519|NCT00416455|Secondary|Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
1262520|NCT00416455|Secondary|The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Cervical cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.|||percentage of participants||95% Confidence Interval|Mean
1262521|NCT00416455|Secondary|The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||Percentage of participants||95% Confidence Interval|Mean
1262522|NCT00416455|Secondary|The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis|The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
1262523|NCT00416455|Secondary|The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.|Before surgery (DCT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.|||percentage of participants||95% Confidence Interval|Mean
1262524|NCT00416455|Primary|The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.|||percentage of participants||95% Confidence Interval|Mean
1262525|NCT00416455|Primary|The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.|Before surgery (FDG-PET-CT) and after surgery (pathology)|Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
1262526|NCT00416312|Primary|Tumor Absorbed Dose|tumor absorbed dose (Gy)|up to 4 years||||Gy|tumor|Standard Deviation|Mean
1262527|NCT00416195|Secondary|Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF||Baseline, Day 85 through Day 112|ITT population (LOCF)|||Percent change||Full Range|Median
1262528|NCT00416195|Primary|Percentage of Responders During the Maintenance Phase|A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.|Day 85 through Day 112|ITT population- all subjects in the Safety Population (all randomized subjects who took at least 1 dose of study drug) who had at least 2 weeks of baseline seizure frequency data and at least 1 week of seizure frequency data after baseline (LOCF - last observation carried forward)|||Percentage of Participants|||Number
1262529|NCT00416182|Secondary|Pulmonary Function|prior to surgery and end of study spirometry as measured by forced expiratory volume in 1 second (FEV1) percent predicted. The change over the course of the study (1 year minus baseline) is reported. A higher value indicates a better outcome.|baseline and 1 year||||percentage of predicted FEV1||Full Range|Mean
1262530|NCT00416182|Secondary|Chronic Sinusitis Survey Score|pre-surgery and end of trial (12 months) Reduction in scores (baseline minus 1 year) are recorded The chronic sinusitis survey consists of 6 questions, ranges from 0-24, a lower score indicates the best possible outcome.|baseline and 1 year||||units on a scale||95% Confidence Interval|Mean
1262531|NCT00416182|Primary|Improvement in Appearance of Nasal Passages/Sinuses|"periodic endoscopic photos of sinuses by ear-nose-throat (ENT) surgeon. The scale for scoring severity of disease ranges from 0 (best possible outcome) to 2 (worst possible outcome).~independent blinded scoring by 2 surgeons difference in scores pre and post are reported (1 year minus baseline)"|baseline and 1 year||||units||95% Confidence Interval|Mean
1262532|NCT00416182|Primary|Computed Tomography Evidence of Less Sinus Disease|compare sinus CT pre-op (baseline) to one year after initiation of study drug Difference in pre and post scores by Lund-McKay scoring system are reported (1 year minus baseline) The Lund-Mackay scoring system was used to evaluate the extent and severity of sinusitis. The scale ranges from 0 (best possible outcome with complete lucency of all sinuses) to 24 (worst possible outcome with complete opacification of all sinuses)|baseline and 1 year||||units on a scale||95% Confidence Interval|Mean
1262533|NCT00416078|Other Pre-specified|Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline|Frequency count of individuals placed in assisted living or nursing homes|baseline to end-of-follow-up (12 months from baseline)|Numbers vary; patients only at risk for out-of-home placement if alive and with data during follow-up periods|||participants|||Number
1262534|NCT00416078|Primary|Change in Caregiver Depression From Baseline|Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression|baseline to end-of-treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)|||units on a scale||Standard Error|Least Squares Mean
1262535|NCT00416078|Primary|Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline|Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver’s level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.|baseline to end of treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)|||units on a scale||Standard Error|Least Squares Mean
1262536|NCT00416078|Primary|Change in Frequency of Patient Problematic Behavioral Patterns From Baseline|Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.|baseline to end of treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)|||units on a scale||Standard Error|Least Squares Mean
1262537|NCT00416078|Primary|Change in Caregiver Burden From Baseline|Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.|baseline to end-of-treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)|||units on a scale||Standard Error|Least Squares Mean
1262538|NCT00416078|Secondary|Change in Caregiver Report of Patient Medication Adherence From Baseline|Adherence to prescribed medication regimen rated by caregiver on a 1 (0%) to 5 (100%) scale. Higher scores indicate better adherence. Values in statistical table below are least square estimates, and thus may be slightly out-of-range of actual respondent choices on scale.|baseline to end-of-treatment (6 months)|measure was added to study while in process|||units on a 1-5 scale||Standard Error|Least Squares Mean
1262539|NCT00415909|Primary|Response Rate (Major and Complete Cytogenetic Response)|Rate is defined as number of participants with response of Major and Complete cytogenetic response out of total study participants. Response evaluated at one and 3 months from start of therapy, then every 3 months in patients with response, for one year, then every 6-12 months. Responses classified according to suppression of Philadelphia (Ph) chromosome by cytogenetic analysis: a) Complete cytogenetic response - Not Ph positive; b) Major cytogenetic response - Ph positive 1-34% of pretreatment value; c) Minor cytogenetic response - Ph positive 35-65% of pretreatment value; d) Minimal cytogenetic response - Ph positive 65-99% of pretreatment value; e) No cytogenetic response - Ph positive 100% of pretreatment value.|Evaluated at baseline (pretreatment) up to 12 months|All three patients received the planned 9 administrations of TALL-104.|||percentage of participants|||Number
1262540|NCT00415870|Secondary|Program Satisification||4 months|||||||
1262541|NCT00415870|Secondary|Compliance With Food Monitoring Activities (e.g, Type of Food, Amount)||4 months|||||||
1262542|NCT00415870|Primary|Mean Weight (kg)||4 months||||kg||Standard Deviation|Mean
1262543|NCT00415857|Secondary|Number of Participants With Immunologic Response|Immunologic Response (immune response) is defined as an increase of ≥ 0.5 PR1-HLA-A2 [human leukocyte antigen-A2 (HLA-A2)] tetramer cells / μl at the time of either the 3rd or 4th vaccination compared to the pre study absolute PR1-HLA-A2 tetramer cells / μl. Participants receive a total of 4 vaccinations over a period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18). Participants assessed after 3rd and 4th vaccination for immunologic response.|Period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18).||||participants|||Number
1262544|NCT00415857|Primary|Molecular Response Rate|Molecular response rate is number of respondents compared to total participants. Molecular Response is defined as a greater than a one-log reduction of Breakpoint Cluster Region-Abelson Murine Leukemia (BCR-ABL) transcript levels by quantitative polymerase chain reaction (PCR) from the baseline level at the time vaccination was initiated, or a disappearance of BCR-ABL transcripts, as measured by reverse transcription polymerase chain reaction (RT-PCR), occurring within 6 months from the last vaccination. Participants receive a series of 4 vaccinations administered at 3-week intervals and the fourth (final) vaccination administered 3 months after the third vaccination with blood draw to test PCR following every 3 months to test the level of leukemia in the blood and to see if disease is responding to the vaccine.|Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period.||||percentage of participants|||Number
1262568|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Bother|Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of bother. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.|Baseline and 52 weeks|Full analysis set|||Units on a scale||Standard Error|Least Squares Mean
1262545|NCT00415636|Secondary|Percentage of Participants With Best Overall Response|Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm * 100.|baseline up to 24 months|A modified intent-to-treat population (mITT) was used to summarize the data for tumor response. The mITT population consisted of all participants who received any dose of study drug and had at least 1 nonmissing postbaseline tumor response assessment.|||Percentage of participants|||Number
1262546|NCT00415636|Secondary|Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])|AUC[0-∞] was calculated from the plasma concentration data of LY2603618 versus time profiles.|Day 1 and Day 9 of Cycle 1|Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.|||nanograms*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
1262547|NCT00415636|Secondary|Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618|Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.|Day 1 and Day 9 of Cycle 1|Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.|||nanograms per millimeter (ng/mL)||Standard Deviation|Mean
1262548|NCT00415636|Primary|Number of Participants With Adverse Events (AEs)|Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.|baseline up to 24 months|The safety population was comprised of all participants who received any amount of LY2603618.|||Participants|||Count of Participants
1262549|NCT00415623|Secondary|Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg||Baseline, Week 4, and Week 8|Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.|||ng/mL||95% Confidence Interval|Geometric Mean
1262550|NCT00415623|Secondary|Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg||Baseline, Week 4 and Week 8|Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.|||ng/mL||95% Confidence Interval|Geometric Mean
1262551|NCT00415623|Secondary|Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
1262552|NCT00415623|Secondary|Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 8|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
1262553|NCT00415623|Secondary|Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
1262554|NCT00415623|Secondary|Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 8|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
1262555|NCT00415623|Secondary|Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)|Arithmetic mean of Week 6 & Week 8 by patient for “Change from baseline in DBP at Week 6” and “Change from baseline in DBP at Week 8”|Baseline to Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward|||mmHg||95% Confidence Interval|Least Squares Mean
1262556|NCT00415623|Secondary|Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)|Arithmetic mean of Week 6 & Week 8 by patient for “Change from baseline in SBP at Week 6” and “Change from baseline in SBP at Week 8”|Baseline to Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward|||mmHg||95% Confidence Interval|Least Squares Mean
1262557|NCT00415623|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8|Mean change in the trough DBP|Baseline to Week 8|Full Analysis Set, Last Observation Carried Forward|||mmHg||95% Confidence Interval|Least Squares Mean
1262558|NCT00415623|Primary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 8|Mean change in the trough SBP|Baseline to Week 8|Full Analysis Set, Last Observation Carried Forward|||mmHg||95% Confidence Interval|Least Squares Mean
1262569|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Fatigue|Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of fatigue. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.|Baseline and 52 weeks|Full analysis set.|||Units on a scale||Standard Error|Least Squares Mean
1262624|NCT00414700|Secondary|Safety: Adverse Events|Side effects are recorded as the number of patients with adverse events. These events are coded according to the Medical Dictionary for Regulatory Affairs (MedDRA terms).|continuous up to 60 months||||participants|||Number
1262559|NCT00415610|Other Pre-specified|Particpants Who Achieve Reduction of Blood Pressure and Maintain Treatment Goals (the Specified Systolic Blood Pressure Range for the 18-24 Hour Period) Without Neurological Deterioration or Side Effects Resulting in Death.|"The tolerability of the study treatment was further ascertained by examination of in-hospital, 1-month, or 3-month mortality in each treatment group.~This pilot study was not powered (did not plan to enroll an adequate number of patients) to draw meaningful conclusions about individual adverse event categories, outcome measures, or to make comparisons between the treatment arms beyond the overall feasibility and tolerability of rapidly and significantly lowering SBP following intracerebral hemorrhage.~The timing and magnitude of SBP reduction was also compared to the timing of individual safety events to further evaluate possible relationships between the study treatment, adverse events, and any recognizable safety concerns. This information is available in publication but is not able to be displayed on this website due to formatting restrictions."|From enrollment through 3 months|Serious adverse events were monitored for all patients throughout the 3-month study period; when mortality resulted death was categorized as having occurred prior to or following hospital discharge. The 3-month mortality count includes deaths that occurred earlier. Survival was confirmed at hospital discharge, 1 month, and 3 months.|||Participants|||Count of Participants
1262560|NCT00415610|Secondary|Particpants Who Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals|The ability to maintain the Specified Systolic Blood Pressure Range for the 18-24 Hour Period without Neurological Deterioration or Side Effects|3 months|All subjects were analyzed by treatment arm for the presence of SAEs, neurological deterioration, symptomatic or asymptomatic hematoma expansion, and mortality in-hospital or within 3 months. Pre-specified safety stopping rules were used. The nature and relatedness of events was examined and overseen by an external Data safety and Monitoring Board.|||participants|||Number
1262561|NCT00415610|Primary|Total Number of Serious Adverse Events Within the Initial 72 Hours From Treatment Per Subject|Serious adverse events were ascertained by site investigators using FDA-defined guidelines, defined as any untoward clinical events having been fatal, life-threatening, resulting in new or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage. Subjects were followed closely from randomization through 90 days. The initial 72-hour period was chosen as the most meaningful time period for which to examine SAEs likely to be related to the acute safety of the study treatment.|from treatment initiation through 72 hours|All subjects entered in the trial were followed and their data analyzed for safety measures. Not all subjects entered in the trial survived or remained in the trial to assess final outcomes at 1 or 3 months. When safety stopping rules could not have triggered after 18 initial subjects recruitment was adjusted to weight the subsequent tiers.|||Participants|||Count of Participants
1262562|NCT00415610|Primary|"Number of Participants With Neurological Deteriorations (Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score) During the 24 Hour Treatment,"|Neurological status was monitored quantitatively and independently of other adverse events using two scales. The Glasgow Coma Scale (GCS) score measures level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movements, visual fields, facial palsy, movement in each limb, sensation, language and speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42; 0 indicates normal function and higher scores indicate greater deficit severity.|within the first 72 hours of treatment initiation|All subjects entered in the trial were followed and their data analyzed for safety measures. Not all subjects entered in the trial survived or remained in the trial to assess final outcomes at 1 or 3 months. When safety stopping rules could not have triggered after 18 initial subjects recruitment was adjusted to weight the subsequent tiers.|||participants|||Number
1262563|NCT00415610|Primary|Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier.|Feasibility of treatment was assessed by whether SBP reduction and maintenance within the respective target range was achieved (treatment success) or not (treatment failure), and secondarily by whether a significant difference between treatment arms was achieved. Treatment failure was defined based on the observed hourly hourly minimum SBP remaining greater than the upper limit of the target range for 2 consecutive hours after initiation of nicardipine infusion. Spontaneous decline of SBP below the lower limit of the specific tier was not considered treatment failure as all such declines were asymptomatic.The lower number in the more intensive treatment groups reflects in part the greater challenge of rapidly lowering systolic blood pressure to a more intensive (lower) range, as a higher number of treatment failures as pre-defined by meeting the SBP range goal within 3 hours of symptom onset in this group predictably occurred.|Within 3 hours of symptom onset and sustained through 18-24 hours.|All subjects were evaluated for achievement of the treatment goals.|||participants|||Number
1262564|NCT00415597|Secondary|Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain|Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.|52 weeks|Patients with data at Week 52|||Percent change||Standard Deviation|Mean
1262565|NCT00415597|Secondary|Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain|Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.|12 weeks|Patients with data at Week 12|||Percent change||Standard Deviation|Mean
1262566|NCT00415597|Primary|Subjects With Treatment Emergent Adverse Events|Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).|up to 12 months|Patients treated with study drug|||participants|||Number
1262567|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Activity|"Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of activity. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.~Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates."|Baseline and 52 weeks|Full analysis set|||Units on a scale||Standard Error|Least Squares Mean
1262570|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Symptoms|"Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of symptoms. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.~Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates."|Baseline and 52 weeks|Full analysis set|||Units on a scale||Standard Error|Least Squares Mean
1262571|NCT00415532|Secondary|Percentage of Participants With Platelet Response|Platelet response was defined as platelet counts > 50 x 10^9/L, measured at each study visit (excluding those within 8 weeks of prior rescue medication use) up to the time of splenectomy or the end of initial treatment period, whichever occurred first.|Weeks 1-8, and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|"Full analysis set. N indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1262572|NCT00415532|Secondary|Time to Splenectomy|Time to splenectomy in days calculated from date of randomization to date of splenectomy, or censored at date of end of treatment visit if no splenectomy was done during treatment period.|52 weeks|Full analysis set|||days||95% Confidence Interval|Median
1262573|NCT00415532|Primary|Number of Participants With Treatment Failure During 52-Week Treatment Period|Treatment failure was defined by platelet counts ≤ 20 x 10^9/L for 4 consecutive weeks at the highest recommended dose and schedule, a major bleeding event, or change in therapy due to an intolerable side effect or bleeding symptom.|52 weeks|Full analysis set. Participants who discontinued study during treatment period prior to experiencing treatment failure were considered as having had treatment failure.|||Participants|||Number
1262574|NCT00415532|Primary|Number of Participants With Splenectomy During 52-Week Treatment Period|Occurrence of a splenectomy. Participants who discontinued study during the treatment period prior to reporting a splenectomy were considered as having had a splenectomy.|52 weeks|The Full Analysis set includes all randomized patients.|||Participants|||Number
1262575|NCT00415519|Primary|Percentage of Participants With Abnormal Changes in Sensory Examinations|No primary endpoint was used, because various exploratory analyses were performed.|24 weeks|"A note:~Each three patients of both groups did not have data to Staggering due to data missing. Therefore, concerning staggering, the number of participants analysed are 10 in the MCI-186 group and 9 in the placebo of MCI-186 group."|||percentage of participants|||Number
1262576|NCT00415519|Primary|The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients|No primary endpoint was used, because various exploratory analyses were performed.|24 weeks||||percentage of participants|||Number
1262577|NCT00415519|Primary|Percentage of Participants With Adverse Drug Reactions|No primary endpoint was used, because various exploratory analyses were performed.|24 weeks||||percentage of participants|||Number
1262578|NCT00415519|Primary|Percentage of Participants With Adverse Events|No primary endpoint was used, because various exploratory analyses were performed.|24 weeks||||percentage of participants|||Number
1262579|NCT00415519|Primary|Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks|No primary endpoint was used, because various exploratory analyses were performed.|baseline and 24 weeks|"1 patient with missing value at baseline was excluded from the FAS in the MCI-186 group."|||percentage of FVC||Standard Error|Least Squares Mean
1262580|NCT00415519|Primary|Death or a Specified State of Disease Progression|"No primary endpoint was used, because various exploratory analyses were performed.~Any of “death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding” was defined as an event."|24 weeks||||events|||Number
1262581|NCT00415519|Primary|Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks|"No primary endpoint was used, because various exploratory analyses were performed.~0=worst; 48=best"|baseline and 24 weeks||||units on a scale||Standard Error|Least Squares Mean
1262582|NCT00415506|Primary|Improved Control of Inflammation|"For patients with scleritis, disease activity as measured by a modified grading system first described by McCluskey et al. (McCluskey and Wakefield 1987; McCluskey and Wakefield 1991). Improvement in scleritis activity will be defined as a reduction in this grading score of 2 or more, or an overall score of 4 or less by 24 weeks.~For patients with orbital inflammation, disease activity as measured by a modified grading system first devised by Werner (Werner 1977). Improvement in orbital inflammation will be defined as a reduction in this grading score of 2 or more, or an overall score of 3 or less."|24 weeks||||participants|||Number
1262583|NCT00415506|Primary|Reduction of Medications|Reduction (decrease in dosage) of systemic corticosteroids or immunosuppressive therapy by at least 50% by 24 weeks.|24 Weeks|Only patients currently on systemic corticosteroids were analyzed for this outcome point.|||participants|||Number
1262584|NCT00415493|Primary|Net Proportional Change in Nasal Airway Resistance|Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.|One hour||||proportional change (unit-less)||Standard Error|Mean
1262595|NCT00415168|Secondary|Progression Free Survival (PFS)|Defined as time from baseline to the date of disease progression or death on study, whichever occurs first. The PFS 1 definition from the United States Food and Drug Administration (FDA) draft guidance on clinical endpoints was used (FDA 2005).|Baseline to measured progressive disease or death up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||months||95% Confidence Interval|Median
1262585|NCT00415194|Secondary|Correlation Between Biomarkers and Treatment Effect|"Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.~0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data."|Baseline|Zero participants were analyzed because the relatively low number of samples collected would not have yielded a meaningful genomic analysis.|||correlation coefficient|||Number
1262586|NCT00415194|Secondary|Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score|FACT-H&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant’s baseline score, or date of death from any cause. The MID for FACT H&N Total score was a decrease of 12 points.|Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months|Intention to treat (ITT) population with at least Baseline data.|||Months||95% Confidence Interval|Median
1262587|NCT00415194|Secondary|Duration of Response (DoR)|DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is >30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.|time of response to progressive disease up to 24 months|ITT population with a confirmed best response of complete response (CR) or partial response (PR).|||Months||95% Confidence Interval|Median
1262588|NCT00415194|Secondary|Percent of Participants With a Tumor Response (Response Rate)|Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)*100|Baseline to progressive disease or discontinuation of study treatment up to 11 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.|||Percentage of participants|||Number
1262589|NCT00415194|Secondary|Progression-free Survival (PFS)|Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.|baseline to measured progressive disease up to 33 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.|||months||95% Confidence Interval|Median
1262590|NCT00415194|Primary|Overall Survival (OS)|OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant’s last contact prior to that cut-off date.|Baseline to date of death from any cause up to 36 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.|||Months||95% Confidence Interval|Median
1262591|NCT00415168|Secondary|Number of Participants Who Died During the Study||During study drug therapy up to six or eight 21-day cycles or treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||participants|||Number
1262592|NCT00415168|Secondary|Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy|Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) non-laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).|Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||participants|||Number
1262593|NCT00415168|Secondary|Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy|Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).|Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||participants|||Number
1262594|NCT00415168|Secondary|Overall Survival|Defined as the time from baseline to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow up.|Baseline to date of death from any cause up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||months||95% Confidence Interval|Median
1262625|NCT00414700|Secondary|Number of Treatment Failures at 36 Months|"Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 36 months.~The index lesion is the lesion that was initially treated in the study."|Continuous||||Participants|||Number
1262597|NCT00415168|Primary|Percentage of Participants With Objective Response (Objective Response Rate)|Tumor responder is defined as participants exhibiting a best overall study response of complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in sum of longest diameter of target lesions). Non-responders are those who did not meet the above criteria.|Baseline to time of response up to six or eight 21-day cycles of treatment|All patients enrolled in the study with a histologically confirmed diagnosis of adenocarcinoma of the gastric, disease status of measurable disease with presence of at least 1 measurable lesion, with no concurrent administration of any other tumor therapy or known or suspected brain metastasis who received at least 1 dose of study therapy.|||percentage of responders||95% Confidence Interval|Number
1262598|NCT00415051|Secondary|Genetic Stability - Characterize Viral Isolate (Plasma) Frequency|In vitro systems will be used to evaluate genetic stability (examining viremia levels in plasma by direct plaque assay techniques or by blind passage of plasma on Vero cells and sequencing the ribonucleic acid (RNA) and comparing these findings with those from the vaccine virus inoculum).|Days 0-14|1 subject was excluded for receiving another vaccination within 30 days of intended MP-12 vaccination.|||Participants|||Count of Participants
1262599|NCT00415051|Secondary|Immune Response Assessed by Measuring Days to Peak Response for (PRNT50) RVP MP-12 Vaccine|Immune response will be assessed by measuring days to peak response for PRNT50 antibodies to RVF virus|Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12||||Days||Standard Deviation|Mean
1262600|NCT00415051|Secondary|Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus|Immune response will be assessed by measuring days to peak response for PRNT80 antibodies to RVF virus|Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12||||Days||Standard Deviation|Mean
1262601|NCT00415051|Primary|Safety as Measured by the Number of Adverse Events|AE's will be assessed through study completion. Safety will be evaluated by recording the frequency of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.|up to 1 year||||AEs|||Number
1262602|NCT00414973|Secondary|Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men|Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.|Baseline to 12 weeks and 24 weeks|Number of Intention to Treat patients with measurements at respective visit.|||percentage change in osteocalcin||Inter-Quartile Range|Median
1262603|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men|Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.|||percentage change in total hip BMD||Standard Error|Least Squares Mean
1262604|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men|Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.|||percentage change in lumbar spine BMD||Standard Error|Least Squares Mean
1262605|NCT00414973|Secondary|Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women|Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.|Baseline to 12 weeks and 24 weeks|Number of Intention to Treat patients with measurements at respective visits.|||percentage change in osteocalcin||Inter-Quartile Range|Median
1262606|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women|Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.|||percentage change in total hip BMD||Standard Error|Least Squares Mean
1262607|NCT00414973|Primary|Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women|Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline and at least one post baseline measurement. Last Observation Carried Forward.|||percentage change in lumbar spine BMD||Standard Error|Least Squares Mean
1262608|NCT00414908|Other Pre-specified|"Change of Stool Frequency Between Original Baseline and End of Open-label Period (OL)"|Stool frequency is the average of the daily number of stools recorded during the OL period. Lower values indicate a better response. Change was calculated as (OL stool frequency - Baseline stool frequency).|27 weeks|This analysis is done on the Open-Label period of 6 months.|||Number||Standard Deviation|Mean
1262609|NCT00414908|Secondary|Flatulence at the End of Double-blind Period|4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Participants|||Number
1262610|NCT00414908|Secondary|Stool Consistency at the End of the Double-blind Period|4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Participants|||Number
1262611|NCT00414908|Secondary|Abdominal Pain at the End of the Double-blind Period.|4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Participants|||Number
1262626|NCT00414700|Secondary|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 36 Months|Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains: Activities of Daily Living, Quality of Life, Symptoms and Stiffness Pain; Sports not included) at 36 months (change from baseline). Best = 100; worst = 0.|Change from baseline in Overall KOOS at 36 months post-surgery||||Units on a scale||Standard Error|Mean
1262612|NCT00414908|Secondary|Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Number||Standard Error|Least Squares Mean
1262613|NCT00414908|Secondary|Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.|Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Grammes||Standard Error|Least Squares Mean
1262614|NCT00414908|Secondary|Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.|Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Grammes||Standard Error|Least Squares Mean
1262615|NCT00414908|Secondary|Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.|The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Percentage||Standard Deviation|Mean
1262616|NCT00414908|Primary|Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.|"The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response.~Change is calculated as (DB CFA-Baseline CFA)."|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Percentage||Standard Deviation|Mean
1262617|NCT00414817|Secondary|Rate of Acute Health Care Visits for Asthma|annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.|Measured over 19 months of follow-up|Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.|||number of events per year||Standard Deviation|Mean
1262618|NCT00414817|Secondary|Juniper Asthma Quality of Life Questionnaire (Global Score)|Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.|Measured at 19 months|We assessed this outcome on a random sample of study participants that over-sampled intervention participants. All were existing users of ICS at the outset of the study who qualified for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.|||unitless scale ranging from 1-7||Standard Deviation|Mean
1262619|NCT00414817|Primary|Modified Medication Possession Ratio|We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days’ supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days’ supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.|Measured over 19 months|Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.|||fraction of days with medication||Standard Deviation|Mean
1262620|NCT00414726|Primary|Primary Efficacy Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 4 Hours (During Therapy) in the Two Groups.|The NIHSS score ranges from 0 (best score) to 42 (worst score).|4 hours after starting treatment||||0-4 hour change in NIHSS score||95% Confidence Interval|Mean
1262621|NCT00414726|Primary|Primary Safety Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 24 Hours (After Therapy) in the Two Groups.|The NIHSS score ranges from 0 (best score) to 42 (worst score).|24 hours||||0-24 hour change in NIHSS score||95% Confidence Interval|Mean
1262622|NCT00414700|Post-Hoc|Number of Treatment Failures at 60 Months Post-surgery|"Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 60 months.~The index lesion is the lesion that was initially treated in the study."|60 months||||participants|||Number
1262623|NCT00414700|Post-Hoc|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 60 Months|Patient-administered instrument to assess the patients opinion about their knee and associated problems. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.|60 months|FAS population with imputation for treatment failures by LOCF|||units on a scale||Standard Error|Mean
1263166|NCT00411216|Secondary|Activities Specific Balance Confidence Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1262627|NCT00414700|Primary|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12-18 Months (Average)|Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains, Sports not included) at the average of 12-18 months (calculated by averaging change from baseline measurements at 12 and 18 months). Best score = 100; worst score = 0. The analysis was the average of the change from baseline at the 12 and 18 months timepoints.|Average change from baseline in Overall KOOS at 12-18 months post-surgery|FAS (with LOCF for treatment failures)|||points on a scale (0-100)||Standard Error|Least Squares Mean
1262628|NCT00414700|Primary|Overall Histology Assessment on First Subscale of ICRS II Score|Overall histology assessment of cartilage repair, first subscale of International Cartilage Repair Society II (ICRS II) score by two blinded independant histopathologists on a visual analogue scale (VAS 0-100mm) from worst (0) to best (100)|12 months post-surgery|FAS|||Points on a scale||Standard Error|Least Squares Mean
1262629|NCT00414700|Primary|Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining|Histomorphometry on end point biopsies at 12 months post-surgery. Safranin-O (ratio 0-1)+ anti-Collagen II antibody (ratio 0-1) stain signal expressed as a ratio of the total cartilage surface area (Saf O + anti Coll II divided by total surface = ratio 0-2). Safranin-O stains proteoglycans and anti-Collagen II antibody reflects the presence of Collagen II.|12 months post-surgery|Full Analysis Set (FAS)|||Ratio||Standard Error|Least Squares Mean
1262630|NCT00414661|Other Pre-specified|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, 12, 18, 24|Safety analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for the measure and 'n' signifies participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1262631|NCT00414661|Primary|Incidence of Important Infections|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with important infections by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.|||Infections per 100 person-years||95% Confidence Interval|Number
1262632|NCT00414661|Primary|Incidence of Lymphoma|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with lymphoma by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.|||Lymphoma per 100 person-years||95% Confidence Interval|Number
1262633|NCT00414661|Primary|Incidence of Lymphoproliferative Disorders (LPD)|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.|||LPD per 100 person-years||95% Confidence Interval|Number
1262634|NCT00414635|Secondary|Deviation From FOTO Schedule by One Extra Dose|Percentage of FOTO participants who took a dose during weekend planned interuption period|4, 12, 24 weeks||||Percentage of Participants|||Number
1262635|NCT00414635|Secondary|Self-reported Adherence Summary in Both Arms|Percentage of participants who missed one or more doses in weekly regimen.|4, 12 and 24 weeks||||percentage of participants|||Number
1262636|NCT00414635|Secondary|Trough Blood Levels of Efavirenz in Both Arms|blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)|12 or 60 hours||||Percentage of Participants|||Number
1262637|NCT00414635|Secondary|"Absolute Number of Virological Blip Events Occurring Over 24 Weeks"|"Total number of blip events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml"|Baseline to week 24||||blip events|||Number
1262638|NCT00414635|Secondary|Quality of Life|"Participant preference of antiretroviral (ART) regimen determined on a scale ranging from 0 to 10. O was defined as I Perfer taking HIV medications 7 days/week and 10 was defined as I perfer 5 days on and 2 days off. We present results of a single question on quality of life experienced while on their study ART regimen."|4 weeks|The questionnaire was only applicable to FOTO arm|||Units on a Scale||Inter-Quartile Range|Median
1262639|NCT00414635|Secondary|Mean CD4+ T-cell Count Increases From Baseline to Week 24.||Baseline to Week 24||||cells/ml||95% Confidence Interval|Mean
1262640|NCT00414635|Primary|Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)|Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)|24 weeks|Per protocol|||Percentage of Participants|||Number
1262641|NCT00414609|Secondary|Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter|"Fasting blood samples were collected throughout the study and were analyzed at a central laboratory. Percentage of participants with the following clinically significant laboratory values are reported:~Potassium <3.5 mmol/L; Low value (Normal reference range: 3.5- 5.3)~Potassium >5.5 mmol/L and Potassium >6.0 mmol/L; High values (Normal reference range: 3.5-5.3)~Creatinine >176.8 μmol/L; High value (Normal reference range= Male: 62- 106 and Female 44- 80)~Blood Urea Nitrogen (BUN) >14.28; High value (Normal reference range: 2.1- 8.9)"|24 Months|"Extension population (considered as Safety population) consisted of all enrolled patients who received at least one dose of study medication in the extension study. n in each of the categories is the number of participants with data available at the given time-point."|||Percentage of participants|||Number
1262642|NCT00414609|Secondary|Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change|Orthostatic blood pressure change is defined as a decrease of at least 20 mmHg in systolic blood pressure or a decrease of at least 10 mmHg in diastolic blood pressure when a patient moves from a sitting position to a standing position. A patient could show orthostatic blood pressure change at more than one visit. End of study is Month 24 or early discontinuation.|Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24|"Extension population (considered as Safety population) consisted of all enrolled patients who received at least one dose of study medication in the extension study. n in each of the categories is the number of participants with data available at the given time-point."|||Percentage of Participants|||Number
1262643|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12|Change from baseline to Month 12 in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography. LVEF is the fraction of blood (in percent) pumped out of the heart’s left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. This measurement was made by the echocardiography lab. Ejection fraction percentages > 55% are considered normal.|Baseline(extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.|||percent of blood pumped from LV chamber||Standard Deviation|Mean
1262644|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12|Change from baseline to Month 12 in left ventricular end diastolic volume (LVEDV) as measured by echocardiography. LVEDV is a measurement of the volume of blood in the heart’s left ventricular chamber at the beginning of the chamber’s filling with blood. This measurement was made by the echocardiography lab. LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal.|Baseline (extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.|||Milliliter (mL)||Standard Deviation|Mean
1262645|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12|Change from baseline to Month 12 in left ventricular end systolic volume (LVESV) as measured by echocardiography. LVESV is a measurement of the volume of blood in the heart’s left ventricular chamber at the end of the heart’s contraction. This measurement was made by the echocardiography lab. LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal.|Baseline(extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.|||Milliliter (mL)||Standard Deviation|Mean
1262646|NCT00414609|Primary|Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Extension study (24 weeks)|Extension Population (considered as Safety population) consisting of all enrolled patients who received at least one dose of study medication in the extension study.|||Percentage of participants|||Number
1262647|NCT00414609|Secondary|Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography|Change from baseline to end of study in Wall Motion Score (WMS) as measured by echocardiography. WMS was obtained by examining multiple segments of the left ventricle and assigning each segment a score based on myocardial thickening: 1 for normal, 2 for hypokinetic; 3 for akinetic; and 4 for dyskinetic. The WMS was obtained as the average score for the segments visualized and was calculated by the echocardiography lab. Possible values range from 1 to 5. Higher scores are considered worse. Baseline WMS was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.|||Scores on a scale||Standard Error|Least Squares Mean
1262648|NCT00414609|Secondary|Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography|Change from baseline to end of study in infarction segment length (ISL) (%) as measured by echocardiography. This is the length of the myocardial infarction segment as a percentage of the total cavity perimeter length as calculated by the echocardiography lab. Baseline ISL was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.|||percent of total cavity perimeter length||Standard Error|Least Squares Mean
1262649|NCT00414609|Secondary|Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|Change from baseline to end of study in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography. LVEF is the fraction of blood (in percent) pumped out of the heart’s left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. This measurement was made by the echocardiography lab. Ejection fraction percentages > 55% are considered normal. Baseline LVEF was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment )|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.|||percent of blood pumped from LV chamber||Standard Error|Least Squares Mean
1262650|NCT00414609|Secondary|Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)|Change from baseline to end of study in left ventricular end diastolic volume (LVEDV) as measured by echocardiography. (LVEDV) is a measurement of the volume of blood in the heart’s left ventricular chamber at the beginning of the chamber’s filling with blood. This measurement was made by the echocardiography lab. LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal. Baseline LVEDV was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.|||mL||Standard Error|Least Squares Mean
1262651|NCT00414609|Secondary|Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes|Composite outcome 1 included: Cardiovascular (CV) Death, hospitalization for heart failure (HF), or absolute reduction in Left Ventricular Ejection Fraction (LVEF) greater than 6%. Composite outcome 2 included: CV Death, hospitalization for HF, recurrent Myocardial Infarction, Stroke, or Resuscitated Sudden Death. LVEF was measured at baseline and final visit. All other events were adjudicated by a blinded external committee. Each composite endpoint analysis was based on (a) the percent of patients with that endpoint and (b) days in study to 1st event (or last exposure if no event occurred).|LVEF was measured at baseline and at final visit (after 26 to 36 weeks of treatment). Other endpoint components were assessed from randomization until the end of the study (week 36).|Full Analysis Set (FAS) – All randomized patients who either (a) received study drug or (b) did not receive study drug but were not disqualified from randomization.|||Percentage of participants|||Number
1262652|NCT00414609|Primary|Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study.|Change from baseline to end of study in left ventricular end systolic volume (LVESV) as measured by echocardiography. LVESV is a measurement of the volume of blood in the heart’s left ventricular chamber at the end of the heart’s contraction. This measurement was made by the echocardiography lab. LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal. Baseline LVESV was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set (patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment)|||mL||Standard Error|Least Squares Mean
1262653|NCT00414596|Secondary|Number of Patients Who Withdraw From Study.|Total number of patients who withdrew during the 6 weeks of treatment.|6 weeks||||participants|||Number
1262654|NCT00414596|Secondary|Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.|Total number of adverse events reported following 6 weeks of DRX9000 treatment.|Six weeks|All subjects enrolled were included in the analysis. No adverse events related to study device were reported.|||Number of Adverse Events|||Number
1262655|NCT00414596|Secondary|Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.|Patient's satisfaction with treatment procedures following 6 weeks of DRX9000 treatment was measured on a scale from 0-10 (0= very unsatisfied, 10=very satisfied).|Six weeks||||units on a scale||Inter-Quartile Range|Mean
1262656|NCT00414596|Secondary|Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)|Subject functional capacity following 6 weeks of DRX9000 treatment will be measured as a numerical score by the Revised Oswestry Pain Questionaire (scale 0-50, 0=pain without effects). Functional capacity was assessed at Baseline, 3 Weeks and 6 Weeks.|Six weeks||||Change in units of scale||Inter-Quartile Range|Median
1262657|NCT00414596|Secondary|Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.|The number of Subjects reporting VRS greater than or equal to 4 for LBP following completion of 6 weeks of DRX9000 treatment will be recorded.|Six weeks||||participants|||Number
1262658|NCT00414596|Primary|Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)|The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments.|Six weeks||||units on a scale||Inter-Quartile Range|Median
1262659|NCT00414544|Secondary|Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months||3, 9 and 12 months|||||||
1262660|NCT00414544|Primary|Adverse Event Reporting||6 months|||||||
1262661|NCT00414544|Primary|Change in Wrinkle Severity Rating Scale|To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.|baseline and 6 months|Analysis was intention to treat (ITT) and each subject received both CosmetaLife and Control (Restylane) injections into contralateral nasolabial folds, respectively. WSRS units (change from baseline analyzed)|||units on scale||Standard Deviation|Mean
1262662|NCT00414518|Primary|Viral Set Point|set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus|Throughout study||||Log 10 copies virus/ml||Standard Deviation|Mean
1262663|NCT00414518|Primary|Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome||At Week 24||||participants|||Number
1262664|NCT00414518|Primary|Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms||At Week 24||||Log 10 copies of virus/ml||Standard Deviation|Mean
1262665|NCT00414466|Primary|Number of Participants With Treatment-emergent Adverse Events|Evaluation of adverse event profiles between placebo and active treatment groups.|Randomization to Post-randomization Day 29 (includes dose reduction)|All randomized subjects were included as per protocol.|||Participants|||Number
1262666|NCT00414466|Secondary|Responder Analysis Between Active Treatment and Placebo Groups.|Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.|Baseline to Post-randomization Day 22|All 170 randomized subjects were included as per protocol. Subjects experiencing an intolerable adverse event, discontinuing due to an adverse event or lack of efficacy, or not providing data were considered non-responders.|||Participants|||Number
1262667|NCT00414466|Primary|Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.|Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain.|Baseline and Post-randomization Day 22|Primary efficacy analysis was performed on the 167 randomized subjects that completed at least 4 days of the electronic pain diary during the last 7 days prior to the Day 22 or Early Termination Visit as per protocol. No imputation methods were used.|||Scores on a scale||Standard Deviation|Mean
1262668|NCT00414453|Secondary|Kurtzke Expanded Disability Status Scale|Subject completes questionaire on functional status|Occurs at Visit 1|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
1262676|NCT00414453|Secondary|Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)|subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries|rating of adverse events occur at each visit|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
1262677|NCT00414453|Primary|Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period|subject identifies daily pain rating during final week of each treatment period using a numeric rating scale|Daily|Data was not analyzed because we the data is locked and is not available.||||||
1262678|NCT00414440|Secondary|Calculated GFR (mL/Min/1.73 m^2), Change From Baseline by Visit|Change in renal function was assessed by the Glomerular Filtration Rate (GFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.|Months 3, 6, 9, 12, 18 and 24|ITT set, observed cases|||mL/min/1.73m^2|Participants|Standard Deviation|Mean
1262679|NCT00414440|Secondary|Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), at baseline and then months 12 and 24|Baseline, Months 12 and 24|ITT, observed cases|||mmHG|Participants|Standard Deviation|Mean
1262680|NCT00414440|Secondary|Calculated GFR, Change From Baseline at Month 60 by Baseline cGFR|Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.|Months 24, 36, 48 and 60|ITT|||mL/min/1.73 m^2||Standard Deviation|Mean
1262681|NCT00414440|Secondary|Course of Calculated GFR (mL/Min/1.73 m^2) From Month 24 to Month 60|Course of calculated GFR (mL/min/1.73 m^2) at Months 24, 36, 48 and 60|Months 24, 36, 48 and 60|ITT|||mL/min/1.73 m^2||Standard Deviation|Mean
1262682|NCT00414440|Primary|Primary Efficacy Analysis of Total Kidney Volume (mITT Set, Multiple Imputation)|Everolimus (RAD001) compared to placebo with respect to the change from baseline in total kidney volume at Month 24.|Baseline, Month 24|mITT set|||mL||95% Confidence Interval|Mean
1262683|NCT00414388|Secondary|PSA -Biochemical Response|PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.|1-10 months||||percentage of participants|||Number
1262684|NCT00414388|Secondary|Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).|Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.|3-10 months||||percentage of patients|||Number
1262685|NCT00414388|Primary|Percentage of Patients Needing a Dose Reduction.|The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%|participants were followed for an average of 25 months|15 patients required dose reductions.|||percentage of participants|||Number
1262686|NCT00414310|Secondary|Participant Response Durations/Length of Survival|The following scoring system used for patient outcomes: For a patient who died, his/her score is the actual number of weeks he/she survived since the beginning of treatment. For a patient who is still alive, his/her score is the number of weeks he/she has survived since the beginning of treatment plus a number which depends on his/her current status. Based on the median survival weeks in historical data, these numbers will be 40 for those patients who go off-study (resistant), 60 for patients without response but on study, 75 for patients with CRi or PR, and 110 for patients who have achieved CR.|1 Year or to disease progression|||||||
1262687|NCT00414310|Primary|Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML|Complete Remission (CR): CR defined as normalization of peripheral blood and bone marrow with < 5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 10^9/ L, and a platelet count > 100 x 10^9/L). CRi or complete remission with incomplete platelet recovery is defined as above, but platelets <100 x 109/L. Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment. Clinical Benefit: In MDS/CMML, as per International Working Group (IWG) criteria, platelets increase by 50% and to above 30 x 10^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10^9/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 10^9/L. In addition to IWG criteria, in AML, a decrease in bone marrow blasts to <5% also considered clinical benefit.|1 Year|One enrolled participant was not treated.|||Percentage of Participants|||Number
1263167|NCT00411216|Secondary|Disability Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1262688|NCT00414206|Primary|Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.||Baseline to Week 48|A modified MITT population was used, which was prospectively defined as all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy (visual acuity) assessment.|||Percent of subjects|||Number
1262689|NCT00414167|Secondary|Percent BMI Loss|Percent loss in Body Mass Index|8 weeks (baseline and 8 weeks)|Baseline values imputed forward for missing data.|||Percent loss||Standard Deviation|Mean
1262690|NCT00414167|Primary|Frequency of Binge Eating Episodes||One week (at post treatment)|Baseline forward imputation for missing data.|||episodes/week||Standard Deviation|Mean
1262691|NCT00414076|Primary|Progression Free Survival (PFS)|Number of participants progressed or death from study entry.|Every 12 weeks|1 out of 4 participants in the Letrozole arm progressed on study. 2 participants progressed in standard of care|||Participants|||Count of Participants
1262692|NCT00414050|Secondary|Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®|Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.|7 months of age (1 month after 3 doses)|Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.|||mIU/mL||95% Confidence Interval|Geometric Mean
1262693|NCT00414050|Primary|The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®|The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.|7 months of age (1 month after 3 doses)|Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.|||Percentage of participants||95% Confidence Interval|Number
1262694|NCT00414011|Primary|Corneal Epithelial Healing Time|patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)|3 to 4 days after surgery||||days to complete epithelial healing|Participants|Full Range|Median
1262695|NCT00413972|Primary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint After 8 Weeks of Treatment||Baseline, 8 weeks|The number of participants for analysis included those from the ITT data set. 392 subjects were randomized in the study, but 3 of the randomized subjects were not treated and were excluded from the ITT data set. Therefore, only 389 subjects were included in the ITT data set.|||percent change of LDL-C||Standard Error|Mean
1262696|NCT00413959|Secondary|Overall Survival|The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.|4 years||||percentage of participants|||Number
1262697|NCT00413959|Primary|Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.|Percentage of complete responders plus percentage of partial responders equals overall response rate.|4 years|1 pt withdrew before completing two cycles and was not evaluable for OS.|||percentage of patients|||Number
1262698|NCT00413920|Secondary|Number of Participants Requiring Steroids in Non-steroid Treatment Group||Months 3 and 6||||Number of participants|||Number
1262699|NCT00413920|Secondary|Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status|"The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status.~Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.~Slow graft function is defined as a serum creatinine value > 250 µmol/L at day 5."|Month 3|Intent-to-treat population. N in the categories is the number of participants from the total population that fit into that category for each arm/group. For example: in the Delayed Graft Function category there were 25 participants in the Without steroid group and 24 participants in the With Steroid Group.|||Number of participants|||Number
1262700|NCT00413920|Secondary|Number of Participants With Subclinical Histological Rejections|The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.|Month 3|Intent-to-treat population on whom biopsies were performed at 3 months.|||Number of participants|||Number
1262701|NCT00413920|Secondary|Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months|A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.|Month 3|Intent-to-treat population|||Number of participants|||Number
1262702|NCT00413920|Secondary|The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months|If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.|Month 6|Intent-to-treat population|||Number of participants|||Number
1262771|NCT00413660|Secondary|Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)|DAS28-3 (CRP) defined remission was classified as a score of <2.6.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||percentage of participants|||Number
1262703|NCT00413920|Primary|Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation|Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.|6 months post transplantation|Intent-to-treat population|||Number of participants|||Number
1262704|NCT00413894|Secondary|Percentage of Participants Requiring Erythrocyte Transfusions||Visits 1 to 10 (Months -2 to 8)|Safety Population (SAF): All participants who received at least one dose of study medication independent from whether they completed the study or not were included into the safety analysis.|||percentage of participants|||Number
1262705|NCT00413894|Secondary|Percentage of Participants With Hb Fluctuations Within Screening Phase|Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.|Visits 1 to 2 (Months -2 to -1)|ITT Population|||percentage of participants|||Number
1262706|NCT00413894|Secondary|Percentage of Participants With Hb Fluctuations Within Evaluation Phase|Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.|Visits 8 to 10 (Months 6 to 8)|ITT population|||percentage of participants|||Number
1262707|NCT00413894|Secondary|Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels|"Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.~Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted."|Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)|ITT Population;|||percentage of participants|||Number
1262708|NCT00413894|Secondary|Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 1 to 2 (Months -2 to -1)|ITT Population; n = number of participants in the specified category|||percentage of participants|||Number
1262709|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 1 to 2 (Months -2 to -1)|ITT Population; n = number of participants in the specified category|||percentage of participants|||Number
1262710|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase||Visits 1 to 2 (Months -2 to -1)|ITT Population|||percentage of participants|||Number
1262711|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase||Visits 1 to 2 (Months -2 to -1)|ITT Population: All participants having received at least one dose of study medication and having at least one Hb value measurement under C.E.R.A. were included.|||percentage of participants|||Number
1262712|NCT00413894|Primary|Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 8 to 10 (Months 6 to 8)|CP; n = number of participants in the specified category|||percentage of participants|||Number
1262713|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 8 to 10 (Months 6 to 8)|CP; number (n) equals (=) number of participants in the specified category|||percentage of participants|||Number
1262714|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase||Visits 8 to 10 (Months 6 to 8)|CP|||percentage of participants|||Number
1262715|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase||Visits 8 to 10 (Months 6 to 8)|Completer Population (CP) included only participants who completed the study until Visit 10 (Month 8).|||percentage of participants|||Number
1262716|NCT00413777|Secondary|Mean Change From Baseline in Abdominal Girth Measurement- Extension.|The participant had a measurement of their abdominal girth recorded. The measurement will be taken with a tape measure extending around the abdomen at the level of the iliac crests laterally and the umbilicus anteriorly. The examiner should also palpate for each kidney and liver edge, noting presence or enlargement. (By definition if the kidneys are palpable they are enlarged, the liver edge may be palpable but not enlarged).|Baseline to Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||cm||Standard Deviation|Mean
1262834|NCT00413335|Secondary|Mean Percent Change From Baseline in Adiponectin|This refers to the changes of adiponectin levels.|4 months||||percentage of change from baseline||Standard Deviation|Mean
1262717|NCT00413777|Secondary|Mean Change From Baseline in Abdominal Girth Measurement.|The participant had a measurement of their abdominal girth recorded. The measurement will be taken with a tape measure extending around the abdomen at the level of the iliac crests laterally and the umbilicus anteriorly. The examiner should also palpate for each kidney and liver edge, noting presence or enlargement. (By definition if the kidneys are palpable they are enlarged, the liver edge may be palpable but not enlarged).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||cm||Standard Deviation|Mean
1262718|NCT00413777|Secondary|Mean Change From Baseline in Patient-assessed Renal Pain Scale- Extension.|Participants were asked the question to assess the relative level of pain attributed to their kidneys. This question was, “On a scale of 0 to 10, with zero represented no pain at all and 10 represented the worst pain ever experienced, what was the worst kidney pain experienced in the last 4 months?” If the latest assessment was less than 4 months prior, the question was substituted “since your last visit” for “in the last 4 months”. The same interrogator designated to this task was used throughout the study for each participant.|Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||Units on a scale||Standard Deviation|Mean
1262719|NCT00413777|Secondary|Mean Change From Baseline in Patient-assessed Renal Pain Scale.|Participants were asked the question to assess the relative level of pain attributed to their kidneys. This question was, “On a scale of 0 to 10, with zero represented no pain at all and 10 represented the worst pain ever experienced, what was the worst kidney pain experienced in the last 4 months?” If the latest assessment was less than 4 months prior, the question was substituted “since your last visit” for “in the last 4 months”. The same interrogator designated to this task was used throughout the study for each participant.|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||Units on a scale||Standard Deviation|Mean
1262720|NCT00413777|Secondary|Mean Change From Baseline in MAP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
1262721|NCT00413777|Secondary|Mean Change From Baseline in dBP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
1262722|NCT00413777|Secondary|Mean Change From Baseline in sBP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
1262723|NCT00413777|Secondary|Mean Change From Baseline in Mean Arterial Pressure (MAP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
1262724|NCT00413777|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (dBP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
1263168|NCT00411216|Primary|Subjective Complaints: (All Pre- and Post-intervention):|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1288248|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36||Month 36||||L||Standard Error|Mean
1262725|NCT00413777|Secondary|Mean Change From Baseline in Systolic Blood Pressure (sBP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
1262726|NCT00413777|Secondary|Change From Pre-dose Baseline in Renal Function Estimated by GFR- Extension.|GFR was estimated using reciprocal serum creatinine formula. The formula does not adjust for body weight or height, but this may be done to normalize to body surface area. The formula for reciprocal Serum creatinine is: 1/Pcr. (Pcr = serum creatinine concentration [mg/dL]). Clinic weight scales were calibrated at least yearly.|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||dL/mg||Standard Deviation|Mean
1262727|NCT00413777|Secondary|Percent Change From Baseline in Renal Volume-Extension.|TKV was assessed by the central magnetic resonance imaging (MRI) rater.|Baseline to Months 2, 12, 24, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||Percentage change per month||Standard Deviation|Mean
1262728|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime- Extension.|"Urine osmolality at steady state (after at least 4 days of dosing) including “average of troughs” (the mean urine osmolality prior to bedtime).~Samples for this assessment were to be taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day at bedtime. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mOsm/kg||Standard Deviation|Mean
1262729|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose- Extension.|"Urine osmolality at steady state (after at least 4 days of dosing) including “absolute trough” prior to the second daily dose.~Samples for this assessment were taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day immediately preceding the second daily dose. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mOsm/kg||Standard Deviation|Mean
1262730|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose- Extension.|Spot urine osmolality at trough was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), Months 2, 6, 12, 24, 36, Extension Day 1, and Extension Month 12 for all participants. Sample was taken after the first morning’s void and was provided as a mid-stream, clean catch sample. During the titration period (Weeks 1, 2, 3 and 4) and at Month 6, additional samples were collected for the preceding day immediately preceding the 2nd daily dose and at bed-time. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. At the Month 36 visit, participants were given a urine container and brought back the specimen at Extension Day 1. All participants were fasting.|Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12|The intent-to-treat (ITT) dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. Observed cases (OC) dataset were used.|||mOsm/kg||Standard Deviation|Mean
1262731|NCT00413777|Secondary|Change From Pre-dose Baseline in Renal Function Estimated by Glomerular Filtration Rate (GFR).|GFR was estimated using reciprocal serum creatinine formula. The formula does not adjust for body weight or height, but this may be done to normalize to body surface area. The formula for reciprocal Serum creatinine is: 1/Pcr. (Pcr = serum creatinine concentration [mg/dL]). Clinic weight scales were calibrated at least yearly.|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||dL/mg||Standard Deviation|Mean
1262732|NCT00413777|Secondary|Percent Change From Baseline in Renal Volume.|Total Kidney Volume (TKV) was assessed by the central magnetic resonance imaging (MRI) rater.|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||Percentage change per month||Standard Deviation|Mean
1262733|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime.|"Urine osmolality at steady state (after at least 4 days of dosing) including “average of troughs” (the mean urine osmolality prior to bedtime).~Samples for this assessment were to be taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day at bedtime. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mOsm/kg||Standard Deviation|Mean
1262835|NCT00413335|Primary|Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)|This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.|4 months||||percentage of participants|||Number
1262734|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose.|"Urine osmolality at steady state (after at least 4 days of dosing) including “absolute trough” prior to the second daily dose.~Samples for this assessment were taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day immediately preceding the second daily dose. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mOsm/kg||Standard Deviation|Mean
1262735|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose.|Spot urine osmolality at trough was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), Months 2, 6, 12, 24, 36 for all participants. Sample was taken after the first morning’s void and was provided as a mid-stream, clean catch sample. During the titration period (Weeks 1, 2, 3 and 4) and at Month 6, additional samples were collected for the preceding day immediately preceding the 2nd daily dose and at bed-time. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. At the Month 36 visit, participants were given a urine container and brought back the specimen at Extension Day 1. All participants were fasting.|Baseline to Month 36|The intent-to-treat (ITT) dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. Observed cases (OC) dataset were used.|||mOsm/kg||Standard Deviation|Mean
1262736|NCT00413777|Primary|Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study Physician Discretion.|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in a study , whether or not it was considered drug-related by the study physician. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study drug treatment; or if the event was continuous from Baseline and was serious, study drug related, or resulted in death, discontinuation.|AEs were recorded from screening (ICF was signed) until 7-Day follow-up|Safety dataset was defined as all participants who consumed at least 1 dose of study medication. Safety variables analyzed included physical examinations, laboratory tests, vital signs, ECG's and AEs.|||participants|||Number
1262737|NCT00413699|Secondary|Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4|Mean influenza antibody titers at visits 3 and 4.|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Antibody Titer||95% Confidence Interval|Geometric Mean
1262738|NCT00413699|Secondary|Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4|"Mean pneumococcal concentrations (ug/mL) at vaccine baseline (visit 2) and post-vaccination visits (visits 3 and 4) by serotype. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed for each serotype varied, and is provided for each individually.~ug/mL=micrograms per milliliter"|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Concentration (ug/mL)||95% Confidence Interval|Geometric Mean
1262739|NCT00413699|Secondary|Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4|"Geometric Mean Fold Increase From Baseline of Influenza Antigens Measured at Visit 4.~n was the number of participants with valid and determinate assay results for the specified HAI strain at the given visit.~Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Fold Change in Antibody Level||95% Confidence Interval|Geometric Mean
1262740|NCT00413699|Secondary|Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4|"Geometric Mean Fold Increase From Baseline of Pneumococcal Antigens Measured at Visit 4.~n was the number of participants with valid and determinate assay results for the specified serotype at the given visit.~The stated number of participants analyzed was the total number of participants. The actual number of participants analyzed for some serotypes varied, and is provided where it differed from the total number of participants.~Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Fold Change in Antibody Level||95% Confidence Interval|Geometric Mean
1262741|NCT00413699|Secondary|Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4|"Number (%) of participants achieving a satisfactory humoral response to the seasonal influenza vaccine defined as ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2).~The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
1262742|NCT00413699|Secondary|Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4|"Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
1262743|NCT00413699|Secondary|Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of ≥ 1:40 in ≥ 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4|"Number (%) of participants achieving protective antibody titers to the seasonal influenza vaccine as measured by an HAI assay titer of ≥1:40 in ≥2 of 3 influenza antigens measured at vaccine sub-study visits 3 and 4.~The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
1262744|NCT00413699|Secondary|Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by ≥ 4-fold Increase in Antibody Titers|"Number of participants achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
1262745|NCT00413699|Secondary|Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations|"Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
1262746|NCT00413699|Secondary|Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study|"Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.~TSS=Total Sharp Score"|Every 6 months until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Scores on a scale||Standard Deviation|Mean
1262747|NCT00413699|Secondary|Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)|"Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).~The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented."|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Scores on a scale||Standard Deviation|Mean
1262748|NCT00413699|Secondary|Initial Period: Short-Form-36 Health Survey (SF-36) Score|"Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were normed and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented."|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Scores on scale||Standard Deviation|Mean
1262749|NCT00413699|Secondary|Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. Each activity category consisted of 2-3 questionnaire. Each questionnaire was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity that required assistance from another individual or required the use of an assistive device was adjusted to a score of 2 to represent a more limited functional status. Overall score was computed as the sum of total scores divided by the number of questionnaire answered. Total possible HAQ-DI score range: 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.|Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period|"Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories."|||Units on a scale||Standard Deviation|Mean
1262836|NCT00413335|Primary|Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat|This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.|4 months||||percentage of change from baseline||Standard Deviation|Mean
1288249|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36||Month 36||||L||Standard Error|Mean
1262750|NCT00413699|Secondary|Initial Period: Health Assessment Questionnaire – Disability Index (HAQ-DI) Score|Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Units on scale||Standard Deviation|Mean
1262751|NCT00413699|Secondary|Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2|DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of GH. GH is general health or participants’ global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score range is from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.|Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period|"Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories."|||Percentage of participants|||Number
1262752|NCT00413699|Secondary|Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2|"Percent participants with DAS28-4 (ESR) <2.6 and ≤3.2 and percent participants with DAS28-3 (CRP) <2.6 and ≤3.2. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.~DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.~The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission."|Every visit until study completion|Full Analysis Set - No Imputation. The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Percent of participants|||Number
1262753|NCT00413699|Secondary|Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12|DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of general health (GH). GH is general health or participants’ global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.|Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period|"Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories."|||Scores on a scale||Standard Deviation|Mean
1262754|NCT00413699|Secondary|Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])|"Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.~DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.~The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission."|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Score calculated from formula||Standard Deviation|Mean
1262755|NCT00413699|Secondary|Initial Period: Area Under American College of Rheumatology (ACR) n Curve|No data were collected for this endpoint because it was removed from the protocol in a previous amendment.|Not applicable as no data were collected for this endpoint.|No data were collected for this endpoint as it was removed from the protocol in a protocol amendment.||||||
1262763|NCT00413660|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET|FACIT-FS is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262756|NCT00413699|Secondary|Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses|ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant’s global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant’s assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant’s overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.|Month 3, 6, 9 and 12 of Extension Period|"Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories."|||Percentage of participants|||Number
1262757|NCT00413699|Secondary|Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses|The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables.|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Percent of participants|||Number
1262758|NCT00413699|Primary|Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib|Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.|Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period|Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, “Number Analyzed” signifies number of participants evaluable for specified categories.|||Percentage of participants|||Number
1262759|NCT00413699|Primary|Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis|Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114.|Includes AEs for every visit and up to 999 days after last dose of study drug|The stated number of participants analyzed is the total number of participants enrolled in each group. The number of evaluable participants is the number remaining in the study in the given time period.|||Number of participants|||Number
1262760|NCT00413699|Primary|Extension Period: Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:<0.8*lower limit of normal (LLN), platelet<0.5*LLN/>1.75*upper limit of normal (ULN), white blood cell (WBC)<0.6*LLN/>1.5*ULN, lymphocyte, neutrophil, protein, albumin <0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: >1.2*ULN; bilirubin>1.5*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN/>1.1*ULN; glucose<0.6*LLN/>1.5*ULN; Urine (specific gravity<1.003/>1.030, pH<4.5/>8, glucose, ketone, protein, blood/Hg(>=1; RBC, WBC>=20; creatinine kinase>2*ULN).|Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)|Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.|||Participants|||Count of Participants
1262761|NCT00413699|Primary|Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)|Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.|||Participants|||Count of Participants
1262762|NCT00413699|Primary|Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports|"Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each.~Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell"|Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug|For abnormal laboratory results, those listed include both mandatory and optional laboratory tests. The number of participants analyzed is the number with at least one evaluable observation of the given laboratory test. Fasting lipids were only collected from participants who enrolled more than 14 days after last visit of their qualifying study.|||Number of participants|||Number
1262764|NCT00413660|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue scale (FS) is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262765|NCT00413660|Secondary|Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262766|NCT00413660|Secondary|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262767|NCT00413660|Secondary|Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262768|NCT00413660|Secondary|Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262769|NCT00413660|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262770|NCT00413660|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1269969|NCT00360334|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure from baseline to endpoint|26 weeks|Full Analysis Set|||mmHg||Standard Error|Least Squares Mean
1262772|NCT00413660|Secondary|Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)|Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||percentage of participants|||Number
1262773|NCT00413660|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262774|NCT00413660|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262775|NCT00413660|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mg/dL||Standard Deviation|Mean
1262776|NCT00413660|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mg/dL||Standard Deviation|Mean
1262777|NCT00413660|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262778|NCT00413660|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1262779|NCT00413660|Secondary|Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
1262780|NCT00413660|Secondary|Physician Global Assessment of Arthritis|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
1263976|NCT00406315|Secondary|Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16|Total cholesterol value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||milligram (mg)/deciliter (dL)||Standard Deviation|Mean
1262781|NCT00413660|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
1262782|NCT00413660|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
1262783|NCT00413660|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
1262784|NCT00413660|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
1262785|NCT00413660|Secondary|Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||swollen joints||Standard Deviation|Mean
1262786|NCT00413660|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||swollen joints||Standard Deviation|Mean
1262787|NCT00413660|Secondary|Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||tender joints||Standard Deviation|Mean
1262788|NCT00413660|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||tender joints||Standard Deviation|Mean
1262789|NCT00413660|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n: calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 2, 4, 6, 8, 12|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1262790|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1262874|NCT00413231|Secondary|Percentage of Participants That Experienced One or More Major Adverse Events|Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
1262791|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1262792|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1262793|NCT00413660|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Baseline Observation Carried Forward (BOCF).|||percentage of participants|||Number
1262794|NCT00413634|Secondary|Diastolic Blood Pressure|Diastolic blood pressures in patients with ET receiving Agrylin|over 1 day|Safety population|||mmHg||Standard Deviation|Mean
1262795|NCT00413634|Secondary|Systolic Blood Pressure|Systolic blood pressures in patients with ET receiving Agrylin|over 1 day|Safety population|||mmHg||Standard Deviation|Mean
1262796|NCT00413634|Primary|Vz/F of Active Metabolite||over 1 day|PK population|||L||Standard Deviation|Geometric Mean
1262797|NCT00413634|Primary|CL/F of Active Metabolite||over 1 day|PK population|||L/h||Standard Deviation|Geometric Mean
1262798|NCT00413634|Primary|T 1/2 of Active Metabolite||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
1262799|NCT00413634|Primary|AUC of Active Metabolite||over 1 day|PK population|||ng.h/ml||Standard Deviation|Geometric Mean
1262800|NCT00413634|Primary|Tmax of Active Metabolite||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
1262801|NCT00413634|Primary|Cmax of Active Metabolite|An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.|over 1 day|PK population|||ng/ml||Standard Deviation|Geometric Mean
1262802|NCT00413634|Primary|Volume of Distribution (Vz/F) of Agrylin||over 1 day|PK population|||L||Standard Deviation|Geometric Mean
1262803|NCT00413634|Primary|Total Clearance (CL/F) of Agrylin||over 1 day|PK population|||L/h||Standard Deviation|Geometric Mean
1262804|NCT00413634|Primary|Terminal Half-life (T 1/2) of Agrylin||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
1262805|NCT00413634|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin||over 1 day|PK population|||ng.h/ml||Standard Deviation|Geometric Mean
1262806|NCT00413634|Primary|Time of Maximum Plasma Concentration (Tmax) of Agrylin||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
1262807|NCT00413634|Secondary|Heart Rate|Heart rates in patients with ET receiving Agrylin|over 1 day|Safety population|||beats/min||Standard Deviation|Mean
1262808|NCT00413634|Secondary|Platelet Count|Platelet counts in patients with ET receiving Agrylin|over 1 day|Safety population (defined as all patients who received study treatment)|||x 1,000,000,000/L||Standard Deviation|Mean
1262809|NCT00413634|Primary|Maximum Plasma Concentration (Cmax) of Agrylin||over 1 day|PK population (defined as all patients with post-dose drug concentration data)|||ng/ml||Standard Deviation|Geometric Mean
1262810|NCT00413582|Secondary|Time in the Operating Room||1 week||||hours||Standard Deviation|Mean
1262811|NCT00413582|Primary|Length of Hospitalization||1 week||||days||Standard Deviation|Mean
1262812|NCT00413478|Primary|Tumor Response Rate (Complete, Partial) of Azacytidine|Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count > 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be > 11g/dl without transfusions. Lymphocyte count <4000/micL. On bone marrow aspirate lymphocyte % should be <30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils > 1500/ micL or >50 % improvement from baseline, platelet count >100,000/micL or >50 % improvement from baseline. Hemoglobin >11g/dl or >50% improvement from baseline. A reduction of >50% in Leukocyte count or <30 % lymphocytes with residual disease on biopsy for nodular PR.|3 to 8 weeks treatment cycles, continuation up to 1 year||||percentage of participants|||Number
1262813|NCT00413413|Secondary|Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)|Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|End of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
1262814|NCT00413413|Secondary|Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)|Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|End of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
1262815|NCT00413413|Secondary|Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)|A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
1262816|NCT00413413|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||mmHg||Standard Error|Least Squares Mean
1262817|NCT00413413|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||mmHg||Standard Error|Least Squares Mean
1262818|NCT00413400|Secondary|Adipocyte Messenger Ribonucleic Acid (mRNA) Levels of Adipocytokines Including Tumor Necrosis Factor (TNF) -Alpha|fold-change in subcutaneous adipose tissue expression of TNF-alpha (mRNA) after 6 months|6 months||||fold-change||Standard Error|Mean
1262819|NCT00413400|Secondary|Lipid Levels|total cholesterol (mg/dL) at 6 months|6 months||||mg/dL||Standard Error|Mean
1262820|NCT00413400|Secondary|Other Adipocytokines|circulating resistin at 6 months|6 months||||ng/mL||Standard Error|Mean
1262821|NCT00413400|Secondary|Tumor Necrosis Factor (TNF) Receptor|Circulating concentrations of Tumor necrosis factor receptor 2 (TNFR2) at 6 months|6 months||||pg/mL||Standard Error|Mean
1262822|NCT00413400|Secondary|Body Composition|6 month visceral adipose tissue (cm^2) - cross-sectional area of the visceral adipose tissue at the level of the 4th lumbar vertebrae was measured using single-slice abdominal computed tomography (CT) scan|6 months||||cm^2||Standard Error|Mean
1262823|NCT00413400|Secondary|Cardiac Echo Ejection Fraction (EF)|change in EF (6mo - baseline). Please note that the value given is the absolute change in EF (which has units of percent), not the percent change in the variable.|Baseline to 6 months||||percent||Standard Error|Mean
1262824|NCT00413400|Secondary|White Blood Cell (WBC) Count|Change in WBC during study (WBC at six months minus WBC at baseline)|Baseline to 6 months||||th/cumm||Standard Error|Mean
1262825|NCT00413400|Secondary|Endothelial Function|Reactive Hyperemia Index (RHI) using peripheral artery tonometry (using Endo-PAT 2000). Peripheral artery tonometry measures blood flow in the tip of the index finger at baseline and in response to vaso-occlusion (inflated blood pressure cuff). The reactive hyperemia index is an index of vasodilation after occlusion compared to baseline. A higher value indicates better vasoreactivity. As this is a relatively new test, there are no thoroughly validated clinically utilized norms.|6 months||||(index)||Standard Error|Mean
1262826|NCT00413400|Secondary|Glucose Tolerance|Fasting glucose (mg/dL) at 6mo|6 months||||mg/dL||Standard Error|Mean
1262827|NCT00413400|Primary|Adiponectin|The ratio of circulating high molecular weight (HMW) adiponectin to total adiponectin ratio (HMW:total Adiponectin) at 6 months is reported.|6 months||||(ratio)||Standard Error|Mean
1262828|NCT00413400|Primary|Interleukin-6 (IL-6)|6 month value of IL-6 (pg/mL)|6 months||||pg/mL||Standard Error|Mean
1262829|NCT00413400|Primary|C-reactive Protein (CRP)|As a measure of C-reactive protein (CRP), which is an inflammatory marker, Log10 of the CRP at 6 months is reported|6 months||||Log10 mg/L||Standard Error|Mean
1262830|NCT00413374|Primary|Death|All-cause mortality|30 Days|Intention to treat|||Participants|||Count of Participants
1262831|NCT00413374|Primary|Recurrent VTE|Major clotting complication (recurrent VTE) as defined as recurrent acute pulmonary embolism confirmed on chest CT or recurrent deep vein thrombosis in the contralateral extremity confirmed with venous ultrasound or CT scan while on once daily enoxaparin therapy.|30 Days||||participants|||Number
1262832|NCT00413374|Primary|Major Bleeding Complication|Major bleeding complication as defined as spinal, retroperitoneal, or intracranial bleeding; drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding.|30 Days||||participants|||Number
1262833|NCT00413335|Primary|Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)|It refers to the percent changes of hepatic fat content.|4 months||||percentage of change from baseline||Standard Deviation|Mean
1262837|NCT00413335|Primary|Mean Percent Change From Baseline in Whole-body Insulin Sensitivity|This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).|4 months||||percentage of change from baseline||Standard Deviation|Mean
1262838|NCT00413283|Secondary|Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle|Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.|8 days|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.|||Participants|||Number
1262839|NCT00413283|Secondary|Platelet Count on Day 22|Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group|Day 22|Efficacy Analysis Set, composed of all randomized participants except those who were replaced|||10^9/L||Standard Deviation|Mean
1262840|NCT00413283|Secondary|Number of Participants With Platelet Transfusions|Number of participants who were administered platelet transfusions during first on study treatment cycle.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.|||Participants|||Number
1262841|NCT00413283|Secondary|Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.|The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count < 50 x 10^9/L, but ≥ 25 x 10^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count < 25 x 10^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.|||Participants|||Number
1262842|NCT00413283|Secondary|Duration of Grade 3 or 4 Thrombocytopenia|The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced (participants who discontinued prior to the completion of at least 1 romiplostim treatment cycle for non-platelet-related reasons).|||days||Standard Deviation|Mean
1262843|NCT00413283|Primary|Number of Participants With Adverse Events|This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.|4 months|Safety Analysis Set, composed of all randomized participants who received at least one dose of study medication.|||Participants|||Number
1262844|NCT00413244|Secondary|IIEF-V: Over-all Satisfaction|Questions 13,14 of the IIEF relates to specifically to overall satisfaction scale from 0 - 10 (very dissatisfied to very satisfied)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
1262845|NCT00413244|Secondary|IIEF-IV: Intercourse Satisfaction|Questions 6,7, 8 of the IIEF relates to intercourse satisfaction scale 0 - 15 (from very dissatisfied to very satisfied)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
1262846|NCT00413244|Secondary|IIEF -III: Sexual Desire|Questions 11-12 of the IIEF relates to sexual desire scale 0-10 (from very low to very high)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
1262847|NCT00413244|Secondary|IIEF-II Orgasmic Function|Questions 9-10 of the IIEF relates to orgasmic function scale 0 - 10 (from no impairment to severe impairment)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
1262848|NCT00413244|Secondary|International Index of Erectile Function (IIEF)|Questions 1-5 15 of the IIEF relates to erectile function scale 0 - 30 (severe erectile dysfunction to no erectile dysfunction).|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
1262849|NCT00413244|Secondary|Aging Male Symptoms (AMS)|The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
1262850|NCT00413244|Secondary|Metabolic Equivalents of Task (METS)|The Metabolic Equivalent of Task (MET), or simply metabolic equivalent, is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate, set by convention to 3.5 ml O2·kg−1·min−1 or equivalently|6 months|Subjects analyzed were only those subjects with ST depression at baseline|||METS units||Standard Deviation|Mean
1262851|NCT00413244|Secondary|International Prostate Symptom Score (IPSS)|"IPSS has 7 questions related to symptoms, each item scored 1-5. Total score can range from 0 to 35 (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 (delighted to terrible.) Data not collected."|6 months|||||||
1262852|NCT00413244|Secondary|Reactive Hyperemia Index|The Reactive Hyperemia Index measures the endothelial function and predicts future coronary events. In general RHI values below 2 are categorized as endothelial dysfunction and have a greater plaque burden, whereas higher RHI values are considered normal or improved endothelial function. PAT is the technique to non-invasively assess endothelial function. It comprises finger probes to evaluate digital volume changes.|6 months|Subjects analyzed were only those subjects with ST depression at baseline|||mls||Standard Deviation|Mean
1262853|NCT00413244|Secondary|Seattle Angina Questionnaire (SAQ)|"A cardiac disease-related quality-of-life measure. The SAQ is a self-report instrument with 19 items that, yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.~Data not collected."|up to 6 months|||||||
1262854|NCT00413244|Primary|Cardiac Stress Testing: Exercise Capacity|Exercise capacity was measured using exercise time.|At 1 month, 3 months, and 6 months|Subjects analyzed were only those subjects with ST depression at baseline|||seconds||Standard Deviation|Mean
1262855|NCT00413244|Primary|Cardiac Stress Test: Time to ST Depression|Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.|at 6 months|Subjects analyzed were only those subjects with ST depression at baseline|||seconds||Standard Deviation|Mean
1262856|NCT00413231|Secondary|Percentage of Participants That Experienced Loss of Stent Graft Patency|Percentage of subjects that experienced loss of stent graft patency within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262857|NCT00413231|Secondary|Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)|Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262858|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Endovascular Procedures|Percentage of subjects that experienced secondary endovascular procedures within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262859|NCT00413231|Secondary|Percentage of Participants That Experienced Type IV Endoleaks|Percentage of subjects that experienced type IV endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262860|NCT00413231|Secondary|Percentage of Participants That Experienced Type III Endoleaks|Percentage of subjects that experienced type III endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262861|NCT00413231|Secondary|Percentage of Participants That Experienced Type I Endoleaks|Percentage of subjects that experienced type I endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262862|NCT00413231|Secondary|Percentage of Participants That Experienced Conversions to Open Surgical Repair|Percentage of subjects that experienced conversions to open surgical repair within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262863|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm Ruptures|Percentage of subjects that experienced aneurysm ruptures within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262864|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm-related Mortality|Percentage of subjects that experienced aneurysm-related within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262865|NCT00413231|Secondary|Percentage of Participants That Died (All-cause Mortality)|Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
1262866|NCT00413231|Secondary|Percentage of Participants That Experienced One or More Major Adverse Events|Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluded subjects that exited before 12 months|||Percentage of participants||95% Confidence Interval|Number
1262867|NCT00413231|Secondary|Percentage of Participants That Experience Loss of Stent Graft Patency|Percentage of subjects that experience loss of stent graft patency within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging|||Percentage of participants||95% Confidence Interval|Number
1262868|NCT00413231|Secondary|Percentage of Participants That Experienced Stent Graft Migration|Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging|||Percentage of participants||95% Confidence Interval|Number
1262869|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak|Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months|Between 30 days and 12 months|Subjects treated or intended to treat with the test device excluding censored subjects (those with no data within the time frame)|||Percentage of participants||95% Confidence Interval|Number
1262870|NCT00413231|Secondary|Percentage of Participants That Experienced Endoleak(s)|Percentage of subjects that experienced endoleak(s) of any type at 12 months|At 12 months|Subjects treated or intended to treat with the test device excluding subjects that did not have proper imaging to identify endoleaks|||Percentage of participants||95% Confidence Interval|Number
1262871|NCT00413231|Secondary|Percentage of Participants That Experienced Conversion to Open Surgical Repair|Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device excluding subjects exited before 12 months|||Percentage of participants||95% Confidence Interval|Number
1262872|NCT00413231|Secondary|Percentage of Participants That Experience Aneurysm Rupture|Percentage of subjects that experience aneurysm rupture within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device excluding subjects that exited before 12 months|||Percentage of participants||95% Confidence Interval|Number
1262873|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm-related Mortality|Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects exited before 12 months and implant failures|||Percentage of participants||95% Confidence Interval|Number
1262875|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge|Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
1262876|NCT00413231|Secondary|Percentage of Participants That Experienced Paraparesis|Percentage of subjects that experienced paraparesis within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
1262877|NCT00413231|Primary|Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >|"The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated.~>~> Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks."|Within 12-months post treatment|Subjects treated or intended to treat with the test device|||Percentage of Participants||95% Confidence Interval|Number
1262878|NCT00413231|Primary|Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)|"Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b.~Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device.~Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak)."|At 12-month post procedure|Subjects treated or intended to treat with the test device|||Percentage of Participants||95% Confidence Interval|Number
1262879|NCT00413231|Secondary|Percentage of Participants That Experienced Paraplegia|Percentage of subjects that experienced paraplegia within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
1262880|NCT00413231|Secondary|Percentage of Participants That Experienced Perioperative Mortality|Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
1262881|NCT00413231|Secondary|Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant|Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.|At implant|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
1262882|NCT00413231|Primary|Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)|Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||90% Confidence Interval|Number
1262883|NCT00413218|Secondary|Time to First Confirmed Negative Culture|The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant’s last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis|Day 1 up to FU1 (2 weeks after EOT (Day 56))|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC.|||Days||95% Confidence Interval|Median
1262884|NCT00413218|Secondary|All-Cause Mortality (ACM) at Day 14 and Day 56|All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.|Day 14 and Day 56|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC.|||Percentage of Participants|||Number
1262885|NCT00413218|Secondary|Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator|Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.|Day 7 and EOT (Day 56)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole|||Percentage of Participants|||Number
1262886|NCT00413218|Secondary|Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator|Success was defined as mycological response (eradication or presumed eradication).|Day 7 and EOT (Day 56)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
1262906|NCT00413153|Secondary|Fasting Glucose|6 month mean and standard deviation for fasting glucose.|6 months|Repeated measures analysis using all available data points for each participant|||mg/dL||Standard Deviation|Mean
1262907|NCT00413153|Secondary|Insulin Sensitivity|6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.|6 months|Repeated measures analysis using all available data points for each participant|||umol/kg/min per uU/mL insulin||Standard Deviation|Mean
1262887|NCT00413218|Secondary|Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).|EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
1262888|NCT00413218|Secondary|Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).|EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
1262889|NCT00413218|Secondary|Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).|EOT (Day 56) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
1262890|NCT00413218|Secondary|Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.|End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
1262891|NCT00413218|Primary|Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use|A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.|End of Intravenous Treatment (EOIV) (Days 11-56)|The ITT population consisted of all randomized participants who received at least one dose of study drug. The mITT population consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. Reporting arms included participants who switched to oral ISA and CAS.|||Percentage of Participants|||Number
1262892|NCT00413192|Secondary|Summary of Adverse Events (AEs)|Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. TEAEs are defined as an adverse event (AE) that emerged during treatment, having been absent at baseline or: reemerged during treatment, having been present at pretreatment (baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. All AEs and SAEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. A participant was counted only once within a System Organ Class (SOC) and preferred term (PT), even if the participant experienced more than one TEAE with a specific SOC and PT. Participants were summarized by treatment group according to the worst CTCAE grade assigned for each PT. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing relationship.|Day 1 of study treatment until progressive disease, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years|Safety analysis set included all participants who received at least one dose of study drug, regardless of their eligibility to enter the study.|||Percentage of participants|||Number
1262893|NCT00413192|Secondary|Overall Survival (OS)|Participants still alive at the end of the study had their time to event censored at the day last known to be alive. Participants lost to follow-up were also censored at the date last known to be alive. 95% CIs for the percentage of participants still alive at the end of the study were presented as described for the primary endpoint, PFS at Week 12.|Date of first dose of study drug to date of death from any cause, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years|EES|||Days||95% Confidence Interval|Median
1262983|NCT00412867|Primary|Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months|The number of patients with an mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|3 months after onset||||participants|||Number
1262894|NCT00413192|Secondary|Duration of Response|Duration of response could be calculated only if a participant achieved a BOR of CR or PR, as defined previously. For consistency with the formula used by the European Organization for Research and Treatment of Cancer (EORTC), the duration was derived as “day of event minus day of first documented CR or PR” (one was not added to the calculation). Participants who were alive without documented progression had their duration of response censored at the day of last follow-up for progression. Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the duration of response by strata. No adjustment was made for participants who started further anticancer therapy prior to disease progression.|Date of first documented CR or PR until the date of first document disease progression (or death), or up to data cutoff 28 Jun 2012, up to approximately 5.5 years|EES|||Days||95% Confidence Interval|Median
1262895|NCT00413192|Secondary|Time to Onset of Response|Time to onset of response could be calculated only if a participant achieved an objective response (BOR of CR or PR as defined previously). Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the time to onset of response by strata. Given the small number of participants with these responses and the large variation in time to onset of response between participants, no comparison could be made among the strata.|Date of first dose of study drug to date of first documented CR or PR, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years|EES|||Days||95% Confidence Interval|Median
1262896|NCT00413192|Secondary|Clinical Response Benefit (CRB)|CRB was defined as the percentage of participants with a BOR of CR or PR or SD as defined by RECIST, described previously. BOR was derived using the same hierarchy as used when determining the status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. CRB = CR + PR + SD|Date of first dose of study drug to documentation of CR, PR, or SD, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years|EES|||Percentage of participants||95% Confidence Interval|Number
1262897|NCT00413192|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in the analysis set who had a BOR of CR or PR based on RECIST v. 1.0 for target lesions. Tumors were assessed using x-rays, magnetic resonance imaging (MRI), or computed tomography (CT) scans, or both, as appropriate. ORR was documented and confirmed by two measurements taken at least 4 weeks apart. CR was defined as the disappearance of all target lesions. PR defined as ≥ 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Best overall response was derived using the same hierarchy as used when determining the PFS status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. ORR = CR + PR|Date of first dose of study drug until documentation of CR or PR, or up to data cutoff 28 Jun 2012, up to approximately 5.5 years|EES|||Percentage of participants||95% Confidence Interval|Number
1262898|NCT00413192|Secondary|Overall Progression Free Survival|Overall PFS was determined from any evidence that the participant had progressed, along with whether or not the participant was still alive at the end of the study. Tumors were evaluated every 6 weeks during treatment, and at least 4 weeks after the first observation of a complete or partial response. After discontinuation of study drug, participants without PD were re-evaluated every 12 weeks, unless a new anticancer therapy was started. Participants were considered as having progressed if they were classed as PD at Week 12, or had a best overall response (BOR) of PD, or had a date of progression, if they discontinued due to PD, died due to PD, or if the PI had recorded a date of progression. A participant was determined progression free if they were alive without PD at the time of study cut-off. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided CIs for the percentage of successes.|First dose of study drug to the date of disease progression or date of death, whichever occurs first, or date of study cut-off 28 Jun 2012, up to 5.5 years|EES|||Days||95% Confidence Interval|Median
1262899|NCT00413192|Primary|Progression Free Survival (PFS) at 12 Weeks|PFS was determined from the Week 12 visit tumor scan and the participant’s date of death. Progression was defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), early death from any cause, or not assessable according to Response Evaluation Criteria In Solid Tumors (RECIST). CR defined as the loss of all target lesions. PR defined as ≥ 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. PD defined as ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since treatment started. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided confidence intervals (CIs) for the percentage of successes.|Week 12|Efficacy evaluable set (EES) consisted of all registered, eligible subjects who had received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1262900|NCT00413153|Secondary|Total Bilirubin|6 month mean and standard deviation for total bilirubin.|6 months|Repeated measures analysis using all available data points for each participant|||mg/dL||Standard Deviation|Mean
1262901|NCT00413153|Secondary|Liver Enzymes -- Alanine Aminotransferase (ALT)|6 month mean and standard deviation for ALT.|6 months|Repeated measures analysis using all available data points for each participant|||U/L||Standard Deviation|Mean
1262902|NCT00413153|Secondary|Liver Enzymes -- Aspartate Aminotransferase (AST)|6 month mean and standard deviation for AST.|6 months|Repeated measures analysis using all available data points for each participant|||U/L||Standard Deviation|Mean
1262903|NCT00413153|Secondary|Immune Parameters -- CD4 Count|6 month mean and standard deviation for CD4+ count.|6 months|Repeated measures analysis using all available data points for each participant|||cells/microL||Standard Deviation|Mean
1262904|NCT00413153|Secondary|Body Composition - Visceral Adipose Tissue|6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).|6 months|Data from participants with 0 & 6 month data analyzed.|||square centimeters||Standard Deviation|Mean
1262905|NCT00413153|Secondary|Lipid Metabolism - Serum Triglyceride|6 month mean and standard deviation for serum triglyceride.|6 months|Repeated measures analysis using all available data points for each participant|||mg/dL||Standard Deviation|Mean
1262908|NCT00413153|Primary|Glucose Trafficking|"6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or trafficked to) muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity."|6 months|Only data from subjects with 0 and 6 month Positron Emission Tomography (PET) scans were analyzed.|||umol/kg/min||Standard Deviation|Mean
1262909|NCT00413062|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
1262910|NCT00413062|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
1262911|NCT00413062|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 12 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.|||participants|||Number
1262912|NCT00413062|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period.~Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
1262913|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
1262914|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
1263009|NCT00412737|Secondary|Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population|RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population.|||participants|||Number
1262915|NCT00413062|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
1262916|NCT00413062|Primary|Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|"The restricted ITT set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data)."|||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
1262917|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
1262918|NCT00413062|Primary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|"The restricted ITT set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data)."|||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
1262919|NCT00413049|Secondary|Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)|Two 24 hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline prior to randomization and one at Week 8 (end of study), in a subset of the intent-to-treat population of patients. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, BP was measured at study specified intervals. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)||||mmHg||Standard Deviation|Mean
1262920|NCT00413049|Secondary|Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)|A patient achieved overall control if the msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
1262921|NCT00413049|Secondary|Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)|A patient achieved diastolic control if their msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
1262930|NCT00413010|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Total Score|Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more depression.|Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||score on scale||Standard Error|Least Squares Mean
1262922|NCT00413049|Secondary|Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)|A patient achieved a diastolic response if their msDBP < 90 mmHg at Week 8 or they had a ≥ 10 mmHg decrease in msDBP compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
1262923|NCT00413049|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||mmHg||Standard Error|Least Squares Mean
1262924|NCT00413049|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||mmHg||Standard Error|Least Squares Mean
1262925|NCT00413036|Secondary|Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review|"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.~Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.~Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.~Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.~Stable Disease(SD): Less than PR, but not progressive disease."|Up to 1459 days|Tumor Control Rate or Proportion of Participants Who Experienced Stable Disease or Better (SD+PR+CRu+CR) was not analyzed. Overall Response Rate (PR+CRu+CR) is presented as the primary endpoint, and because it is a more widely accepted/used efficacy endpoint than tumor control rate, a decision was made not to analyze tumor control rate.||||||
1262926|NCT00413036|Secondary|Progression-free Survival as Determined by Central Review|"Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.~Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population|||Months||95% Confidence Interval|Median
1262927|NCT00413036|Secondary|Time to Progression as Determined by Central Review|"Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.~Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population|||Months||95% Confidence Interval|Median
1262928|NCT00413036|Secondary|Duration of Response as Determined by Central Review|"Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.~For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting."|Up to 1459 days|Intent-to-treat population|||Months||95% Confidence Interval|Median
1262929|NCT00413036|Primary|Participants Categorized by Best Response as Determined by Central Review|"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.~Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.~Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.~Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.~Stable Disease(SD): Less than PR, but not progressive disease.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population|||Participants|||Number
1262931|NCT00413010|Secondary|Clinical Global Impression of Severity (CGI-S) Score|CGI-S is a clinician-rated instrument measuring the severity of a subject’s symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill.|Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||participants|||Number
1262932|NCT00413010|Secondary|Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score|Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||participants|||Number
1262933|NCT00413010|Secondary|Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement|Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety.|Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment. CI for placebo patients was not estimable.|||days||95% Confidence Interval|Median
1262934|NCT00413010|Secondary|Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score|Participant in remission defined as HAM-A total score of <= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety.|Week 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||participants|||Number
1262935|NCT00413010|Secondary|Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)|Responders = YES if subjects achieved a >= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||participants|||Number
1262936|NCT00413010|Secondary|Change in HAM-A Total Score at Weekly Visits|Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.|||score on scale||Standard Error|Least Squares Mean
1262937|NCT00413010|Primary|Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores|Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, 8 weeks|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.|||score on scale||Standard Error|Least Squares Mean
1262938|NCT00412984|Other Pre-specified|Rate of Net-Clinical Benefit During Treatment Period|Rate=number of events of net-clinical benefit per 100 patient years. Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||Number of events per 100 patient years|||Number
1262939|NCT00412984|Other Pre-specified|Number of Participants With Net-Clinical Benefit During Treatment Period|Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
1262940|NCT00412984|Other Pre-specified|Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period|Rate=number of adjudicated TIMI bleeding events per 100 patient years. TIMI Bleeding Criteria: Major bleeding=Intracranial bleeding and/or clinically overt bleeding associated with ≥5 gm/dL fall in Hgb or 15% fall in hematocrit (Hct) from baseline, accounting for transfusions. Minor bleeding=Clinically overt bleeding associated with ≥3 gm/dL fall in Hgb or a ≥10% fall in Hct from baseline, accounting for transfusions.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study. n=number of participants experiencing events.|||Number of events per 100 patient years|||Number
1262947|NCT00412984|Secondary|Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period||"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date, last contact date, or the efficacy cut-off date (30-Jan-2011).|||Number of events per 100 patient years|||Number
1262941|NCT00412984|Other Pre-specified|Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period|Rate=number of adjudicated GUSTO bleeding events per 100 patient years. GUSTO Bleeding Criteria: GUSTO severe (or life-threatening) bleeding: either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention. GUSTO moderate bleeding: bleeding that requires blood transfusion but does not result in hemodynamic compromise.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study. n=number of participants experiencing events.|||Number of events per 100 patient years|||Number
1262942|NCT00412984|Secondary|Rate of All Bleeding Events During Treatment Period|"Rate=number of all bleeding events per 100 patient years. All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death."|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||number of events per 100 patient years|||Number
1262943|NCT00412984|Secondary|Number of Participants With All Bleeding Events During Treatment Period|All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
1262944|NCT00412984|Secondary|Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period|Rate=number of major or CRNM bleed events per 100 patient years. Major=clinically overt and either 1) resulted in a decrease in hemoglobin of 2 g/dL or more, or 2) led to a transfusion of 2 or more units of packed red blood cells, or 3) occurred in a critical site, or 4) led to death. CRNM bleeding=clinically overt, but satisfied no additional criteria required to be adjudicated as a major bleeding event, and led to either 1) hospital admission for bleeding or 2) physician guided medical or surgical treatment for bleeding or 3) a change in antithrombotic therapy.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||number of events / 100 patient years|||Number
1262945|NCT00412984|Secondary|Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period|Major bleeding=bleeding that is clinically overt and that either resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, led to a transfusion of 2 or more units of packed red blood cells, occurred in a critical site, or led to death. CRNM bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
1262946|NCT00412984|Other Pre-specified|Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period|AE: all SAEs or AEs with onset from first dose through 2 days (AEs) or 30 days (SAEs) after the last dose of blinded study drug (BSD). SAE: all SAEs with onset from first dose through 30 days after the last dose of BSD. Bleeding AE: all serious or non-serious bleeding-related AEs with onset from first dose through 2 days after the last dose of BSD. Discontinuations due to AE: all SAEs or AEs with onset from first dose of BSD and with action taken=drug discontinued. Deaths: all deaths occurring from first dose through 30 days after the last dose of BSD.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
1262981|NCT00412867|Secondary|National Institutes of Health Stroke Scale (NIHSS) Score|from 0 (normal) to 40 (most severe)|within 6 hours, from 24 to 36 hours, 3 months after onset.|Two participants (from 24 to 36 hours) and four participants (3 months after onset) were excluded from analysis because of dropouts or missing data|||units on a scale||Full Range|Median
1262948|NCT00412984|Secondary|Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period|For descriptions of Stroke and SE, see Outcome Measure 1. For description of Major bleeding, see Outcome Measure 3.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants who were Warfarin/Vitamin K Antagonist (VKA) naïve (a stratification variable, defined as receiving ≤30 consecutive days of prior warfarin/VKA treatment). Participants not experiencing efficacy endpoint event were censored at earlier of death, last contact, or efficacy cut-off date (30-Jan-2011).|||participants|||Number
1262949|NCT00412984|Secondary|Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period|Diagnosis for an acute or evolving MI=elevation of CK-MB or Troponin T or I ≥ 2 × the ULN, or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. For description of ACD, see Outcome Measure 5.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who didn't experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date, or the efficacy cut-off date (30-Jan-2011). n= number of participants experiencing stated combination of events.|||Number of events per 100 patient years|||Number
1262950|NCT00412984|Secondary|Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period|Diagnosis for an acute or evolving MI=elevation of creatine kinase-MB isoenzyme (CK-MB) or Troponin T or I ≥ 2 × the upper limit of normal (ULN), or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date, or the efficacy cut-off date (30-Jan-2011). n=number of participants experiencing stated event.|||Number of events per 100 patient years|||Number
1262951|NCT00412984|Secondary|Rate of Adjudicated All-Cause Death During the Intended Treatment Period|All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, MI, sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).|||Number of events per 100 patient years|||Number
1262952|NCT00412984|Secondary|Number of Participants With Events of All-Cause Death During the Intended Treatment Period|Death was defined as all-cause mortality. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, myocardial infarction (MI), sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).|||participants|||Number
1262953|NCT00412984|Secondary|Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period|Rate=number of adjudicated major (ISTH) bleed events per 100 patient years. ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||Number of events per 100 patient years|||Number
1262982|NCT00412867|Primary|Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours|The number of patients with sICH|within 36 hours after starting treatment||||participants|||Number
1263173|NCT00411151|Secondary|One-Year Survival|One-year survival is defined as the percentage of participants surviving for at least one year after first dose of trial medication.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.|||Participants (%)||95% Confidence Interval|Number
1262954|NCT00412984|Secondary|Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period|ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more, and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
1262955|NCT00412984|Primary|Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period|Rate=Number of adjudicated stroke or SE events per 100 patient years. Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).|||Number of events per 100 patient years|||Number
1262956|NCT00412984|Primary|Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period|All suspected efficacy events were adjudicated by the Central Events Committee (CEC). Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.|"Time to first event in Intended Treatment Period: started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).|||participants|||Number
1262957|NCT00412971|Secondary|False Positive Detection Rate Patient Level||12 months||||percent of patients|||Number
1262958|NCT00412971|Secondary|Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.||At day 0|ITT|||percentage of participants||95% Confidence Interval|Number
1262959|NCT00412971|Primary|Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.|To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.|1 year|PP. 145 patients were eligible for tumor recurrence. 12 patients has their last follow up after 12 months. Recurrence after 12 months is based on a total of 133 patients.|||precentage of participants||95% Confidence Interval|Number
1262960|NCT00412958|Primary|Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect|The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.|Day 7|Intent-To-Treat (ITT). Full Analysis Set.|||percentage of participants|||Number
1262961|NCT00412932|Secondary|Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||participants|||Number
1262962|NCT00412932|Secondary|Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||participants|||Number
1269970|NCT00360334|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure from baseline to endpoint|26 weeks|Full Analysis Set|||mmHg||Standard Error|Least Squares Mean
1262963|NCT00412932|Secondary|Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||participants|||Number
1262964|NCT00412932|Secondary|Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had baseline and week 12 ABPM measurements.|||mm Hg||Standard Error|Mean
1262965|NCT00412932|Secondary|Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
1262966|NCT00412932|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
1262967|NCT00412932|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
1262968|NCT00412893|Secondary|Number of Participants With Adverse Events, Reported by System Organ Class||From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.|The safety analysis set consists of all randomized patients who received at least one dose of study drug according to the study drug that the participant actually received as the first dose. One participant was randomized to isavuconazole but received voriconazole treatment for the first 7 days and is included in the voriconazole arm for safety.|||participants|||Number
1262969|NCT00412893|Secondary|Percentage of Participants With a Radiological Response Assessed by the Investigator|"Radiological assessments were performed by the investigator. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a < 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by n."|||percentage of participants|||Number
1262970|NCT00412893|Secondary|Percentage of Participants With a Mycological Response Assessed by the Investigator|"Mycological assessments of the participant’s invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.~Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as Not Applicable.~End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."|||percentage of participants|||Number
1262971|NCT00412893|Secondary|Percentage of Participants With a Clinical Response Assessed by the Investigator|"Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator.~Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as Not Applicable. End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."|||percentage of participants|||Number
1262972|NCT00412893|Secondary|Percentage of Participants With a Radiological Response Assessed by the DRC|"Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC.~Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. A participant with no post-baseline radiology data with evidence of radiologic disease at Baseline was considered a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by n."|||percentage of participants|||Number
1262973|NCT00412893|Secondary|Percentage of Participants With a Mycological Response Assessed by the DRC|"Blinded mycological assessments of the participant’s invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.~Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as Not Applicable.~End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded.|||percentage of participants|||Number
1262974|NCT00412893|Secondary|Percentage of Participants With a Clinical Response Assessed by the DRC|"Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC.~Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as Not Applicable. End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."|||percentage of participants|||Number
1262975|NCT00412893|Secondary|Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator|Overall response based on investigators’ assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10).|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|||||||
1262976|NCT00412893|Secondary|All-cause Mortality Through Day 84|All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation.|Through Day 84|Intent-to-treat population|||percentage of participants|||Number
1262977|NCT00412893|Secondary|Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)|"The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses.~Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a > 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42).~End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|Modified Intent-to-treat (mITT) population consisted of ITT participants who had proven or probable IFD as determined by the DRC.|||percentage of participants|||Number
1262978|NCT00412893|Primary|All-cause Mortality Through Day 42|All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation.|Through Day 42|Intent-to-treat population|||percentage of participants|||Number
1262979|NCT00412867|Secondary|Percentage of Participants With Adverse Events and Adverse Drug Reactions||3 months||||percentage of patients|||Number
1262980|NCT00412867|Secondary|Barthel Index (BI)|from 100 (Independent) to 0 (full assistance)|the day of discharge within 3 months after onset, and 3 months after onset|Eleven participants (the day of discharge within 3 months after onset) and four participants (3 months after onset) were excluded from analysis because of dropouts or missing data|||units on a scale||Standard Deviation|Mean
1262984|NCT00412867|Primary|Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)|"Recanalization was evaluated according to the modified Mori grade: Grade 0, no reperfusion; Grade 1, movement of thrombus not associated with any flow improvement; Grade 2, partial (branch) recanalization in <50% of the branches in the occluded-arterial territory; Grade 3, nearly complete recanalization with reperfusion in ≥50% of the branches in the occluded-arterial territory.~The recanalization rate was estimated by regarding Grades 2 and 3 as valid recanalization."|within 6 hours, from 24 to 36 hours after onset||||participants|||Number
1262985|NCT00412854|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From receipt of first dose of study vaccine (Day 0) to study end (Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.|||Subjects|||Number
1262986|NCT00412854|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.|||Subjects|||Number
1262987|NCT00412854|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.|||Subjects|||Number
1262988|NCT00412854|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.|||Subjects|||Number
1262989|NCT00412854|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1262990|NCT00412854|Secondary|Concentrations for Anti-PRP Antibodies|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1262991|NCT00412854|Secondary|Concentrations for Anti-D and Anti-T Antibodies|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1262992|NCT00412854|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL|The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1262993|NCT00412854|Primary|Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies|"The vaccine response was defined as it follows:~for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination;~for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points."|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1262994|NCT00412854|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)|A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1288250|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30||Month 30||||L||Standard Error|Mean
1262995|NCT00412854|Primary|Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1262996|NCT00412841|Secondary|To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI)||6 years|Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis.||||||
1262997|NCT00412841|Secondary|To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients||6 years|Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis.||||||
1262998|NCT00412841|Secondary|Number of Participants With AVN After 4 Months||4 months||||participants|||Number
1262999|NCT00412841|Primary|Number of Participants With AVN After 9 Months||9 months||||participants|||Number
1263000|NCT00412750|Primary|Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB)|The percentage of participants who achieved HBV DNA non-detectability using the COBAS Amplicor HBV Monitor assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL) and Alanine aminotransferase (ALT) normalization defined as ALT within normal limits on two successive visits for a patient with an elevated ALT (>1.0 x upper limit normal) at baseline summarized at Weeks 12 and 24.|Weeks 12 and 24|"Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week."|||Percentage of participants|||Number
1263001|NCT00412750|Secondary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy|Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|Week 52|The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.|||percentage of participants|||Number
1263002|NCT00412750|Secondary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy|Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|Week 52|The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.|||Percentage of participants|||Number
1263003|NCT00412750|Secondary|Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion|HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B ‘e’ antibody (HBeAb). The efficacy was assessed for 18 weeks, 24 weeks, 48 weeks, 52 weeks and on treatment completion (TC).|Weeks 18, 24, 48, 52 and Treatment completion (TC)|"Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week and on treatment completion (TC)."|||Percentage of participants|||Number
1263004|NCT00412750|Secondary|Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52|The percentage of participants with Virologic breakthrough at Week 48 and 52 by treatment. For the subgroup of patients on treatment who achieve HBV DNA >= 1 log10 copies/mL reduction from baseline on 2 consecutive visits, Virologic Breakthrough is defined as HBV DNA >= 1 log10 copies/mL from nadir on two consecutive visits.|Weeks 48 and 52|Intent to treat (ITT) population. As most patients did not reach Week 48 and Week 52, the LOCF was used.|||Percentage of participants|||Number
1263005|NCT00412750|Secondary|Change From Baseline in HBV DNA Concentration|The change from baseline in HBV DNA concentration at Weeks 12 and 24 was analyzed using an analysis of covariance (ANCOVA) model with baseline HBV DNA concentration (log10 copies/ml) as a covariate, treatment and country as factors.|Weeks 12 and 24|Intent to Treat (ITT) population. n= the number of patients who have both baseline and post baseline observation for the respective week|||log 10 copies/ml||Standard Error|Least Squares Mean
1263006|NCT00412750|Primary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy|The original primary efficacy variable was the percentage of patients achieving HBV DNA non-detectability utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|At week 52|The analysis was planned on intention to treat (ITT) population. Due to premature study termination, the analysis was not performed.|||Percentage of participants|||Number
1263007|NCT00412737|Secondary|Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population|RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population.|||participants|||Number
1263008|NCT00412737|Secondary|Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population|RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population.|||participants|||Number
1288251|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30||Month 30||||L||Standard Error|Mean
1263010|NCT00412737|Secondary|Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population|RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population.|||participants|||Number
1263011|NCT00412737|Secondary|Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population was defined as the subset of the ITT population who were culture negative at baseline.|||participants|||Number
1263012|NCT00412737|Secondary|Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|Per-Protocol (PP) population was defined as the subset of the ITT population who did not have any major protocol violations which would impact the assessment of efficacy.|||participants|||Number
1263013|NCT00412737|Primary|Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. Participants were analyzed as per initial randomization.|||participants|||Number
1263014|NCT00412607|Secondary|Change in Left Ventricular Ejection Fraction at 6 Month From Baseline|Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.|6-month follow up|Efficacy analysis cohort subjects with LVEF data available. The statistics for Baseline and 6-month were based on data available from 219 and 166 subjects respectively; the mean change was based on 163 subjects with data at both Baseline and 6-month. Hence the mean change is not the simple subtraction between Baseline and 6-month.|||percentage of blood leaving the heart||Standard Deviation|Mean
1263015|NCT00412607|Secondary|Number of Subjects Achieved Long-term Efficacy Success|Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.|3-year follow up|Subjects in the efficacy analysis cohort who completed 12-month, 2-year, or 3-year follow-up and had available long-term efficacy outcomes at the corresponding time points were included.|||participants|||Number
1263016|NCT00412607|Secondary|Percentage of Subjects Who Achieved Chronic Effectiveness|Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.|6-month follow up|Subjects in the Efficacy analysis cohort who had available chronic effectiveness outcomes were included|||Percentage of participants|||Number
1263017|NCT00412607|Primary|The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.|The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.|Seven days post ablation procedure|Safety Analysis Cohort - defined as subjects who underwent insertion of the study catheter.|||percentage of Adverse Event||95% Confidence Interval|Number
1263018|NCT00412607|Secondary|Percentage of Subjects Achieved Acute Success|Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.|Duration from post-procedure to hospital discharge, up to 2 days|Subjects in the efficacy analysis cohort who had targeted ventricular tachycardia ablated were included. Efficacy Analysis Cohort includes subjects who are enrolled and treated with the study catheter in compliance with the protocol and treated specifically for the study-related arrhythmia.|||Percentage of participants|||Number
1263019|NCT00412607|Primary|The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.|The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.|12-month post ablation|Safety analysis population - subjects who underwent insertion of the study catheter.|||percentage of mortality||95% Confidence Interval|Number
1263020|NCT00412542|Primary|Number of Participants Progression Free at 6 Months With Malignant Gliomas|Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.|6 Months|7 participants enrolled were not evaluated as they were evaluable for toxicity only (not having completed the first cycle/clinical decline/etc.).|||participants|||Number
1288252|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24||Month 24||||L||Standard Error|Mean
1263021|NCT00412529|Secondary|Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative|PCR negative was considered <300 copies/mL. PCR positive was considered =>300 copies/mL.|At Week 12|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||Participants|||Number
1263022|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production|Viral kinetic parameters were estimated with a bi-phasic mathematical model of HBV DNA by using compartments of free virus, infected cells, and uninfected target cells. The model parameter of interest was the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε). Blocking efficiency was within the range between 0 and 1.|Baseline to 12 weeks|Intent to Treat (ITT) population.|||percentage of blocking efficiency||Standard Deviation|Mean
1263023|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss|"Viral kinetic parameters were estimated with a bi-phasic mathematical model:~V(t) = (1-ε)pI(t) – cV(t)~I(t) = (1- η)TV(t) – δI(t)~V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data."|Baseline to 12 weeks|Intent to Treat (ITT) population. The value for the rate of infected cell loss for 1 patient in telbivudine arm was not used in calculation of summary statistics for this variable as this patient showed a deviation from the biphasic pattern in viral kinetic modeling.|||infected cell loss per day||Standard Deviation|Mean
1263024|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance|"Viral kinetic parameters were estimated with a bi-phasic mathematical model:~V(t) = (1-ε)pI(t) – cV(t)~I(t) = (1- η)TV(t) – δI(t)~V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data."|Baseline to 12 weeks|Intent to Treat (ITT) population.|||clearance per day||Standard Deviation|Mean
1263025|NCT00412529|Secondary|Change in Alanine Aminotransferase (ALT) Levels||From Baseline to Week 12|Intention to treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||IU/L||Standard Deviation|Mean
1263026|NCT00412529|Secondary|The Area Under the Curve (AUC) of HBV DNA Change.|In AUC efficacy analyses, all the visits from baseline to Week 12 visit (including the planned and the repeated) with a non-missing HBV DNA level were included.|From Baseline to Week 12|Intention-to-treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||(log10 copies/mL) * days||Standard Deviation|Mean
1263027|NCT00412529|Secondary|Change in Mean HBV DNA Level|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.HBV DNA reductions, considered as the repeated measures, from baseline to Weeks 2, 4, 8.|Baseline (day 1) to Weeks 2, 4, 8|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||log10 copies/mL||Standard Deviation|Mean
1263028|NCT00412529|Primary|Change in Mean Hepatitis B Virus (HBV) DNA Levels|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.|Baseline (day 1) to Week 12 (day 85)|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||log10 copies/mL||Standard Deviation|Mean
1263029|NCT00412516|Secondary|Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.|Neutralizing antibody titer determined using a 50% plaque-reduction neutralizing assay (PRNT-50) for JE virus|12, 24, 36 months post-JE vaccination||||GMT||95% Confidence Interval|Mean
1263030|NCT00412516|Secondary|Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.|“Seropositive” defined as a person with neutralizing antibody against JE virus at a titer ≥ 1:10 in a 50% plaque-reduction neutralizing assay (PRNT-50)|12 months, 24 months, and 36 months post vaccination||||percentage of subjects seropositive||95% Confidence Interval|Number
1263031|NCT00412516|Secondary|Measles Seropositivity at 12 Months|Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA|12 months post vaccination||||percentage of subjects seropositive||95% Confidence Interval|Number
1263032|NCT00412516|Primary|Measles Seropositivity at 24 and 36 Months|Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA|24, 36 months post vaccination||||percentage of participants seropositive||95% Confidence Interval|Number
1263033|NCT00412464|Primary|Thrombocytopenic Events|Patient’s platelet counts should be kept above 50 x 10^9/L while on study with platelet transfusions as needed with the exception of patients enrolled under the HIT/ suspicion of HIT inclusion (platelet transfusions are contraindicated in HIT). With regards to study patients who experience progressive decreases in platelet count to below 50 x 10^9/L while receiving fondaparinux (excluding patients being treated for HIT or suspicion of HIT), fondaparinux will be discontinued.|Study period which was up to 21 days of fondaparinux||||Adverse Events|||Number
1263047|NCT00412373|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Higher scores indicate worsening."|Baseline|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263034|NCT00412464|Primary|Adverse Events|Adverse events will be defined as any untoward or unexpected event which can be a symptom, physical exam sign or laboratory abnormality. Adverse events will be classified as serious if they lead to prolonged hospitalization, re-hospitalization, transfer to an intensive care unit, or death. Adverse events will be categorized in terms of their likely association with fondaparinux as probably related, possibly related, unrelated, or unknown, and will be recorded according to standard adverse reporting guidelines for clinical trials.|Study period which was up to 21 days of fondaparinux||||Adverse Events|||Number
1263035|NCT00412464|Primary|Bleeding Events|Bleeding assessment Patients will be monitored for bleeding symptoms by physician and nursing assessment. Major bleeding will be defined as bleeding which is in a critical space (intracranial, retroperitoneal, or visceral) or leads to the need for blood transfusion. Minor bleeding will be all other bleeding and will be classified as clinically significant (i.e. If the physician has to take action to treat the minor bleed) or clinically insignificant (i.e. if the physician does not need to intervene to treat the minor bleed).|Study period which was up to 21 days of fondaparinux||||Adverse Events|||Number
1263036|NCT00412464|Primary|Therapeutic Plasma Concentration of Fondaparinux at 21 Days|Subjects all had detailed pharmacokinetic measurements done which were subsequently analyzed in a population pharmacokinetic model. This model then informed the dosing recommendations that were published as a result of the study.|21 days||||mg/dL||Standard Deviation|Mean
1263037|NCT00412464|Primary|Number of Abnormal Lab Results Resulting in Adverse Events.|The primary outcome measure was assessment of safety by reporting the number of abnormal lab results resulting in adverse events. Safety laboratory assessments are as follows: Liver and kidney toxicity will be determined by serial measurements of AST, ALT, total bilirubin, BUN and creatinine. Hematologic toxicity will be assessed by serial CBCs.|Study period which was up to 21 days of fondaparinux||||Adverse Events|||Number
1263038|NCT00412451|Primary|PVD Induction|The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)|Day 14 post-injection|Intent-To-Treat (ITT), Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
1263039|NCT00412425|Primary|Cumulative Participants Response to Palonosetron|Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.|7 days|Analysis was per protocol.|||episodes of nausea/vomiting|||Number
1263040|NCT00412373|Other Pre-specified|Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263041|NCT00412373|Other Pre-specified|Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263042|NCT00412373|Other Pre-specified|Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263043|NCT00412373|Other Pre-specified|Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263044|NCT00412373|Secondary|Participants With Response|Response is defined as a 30% or more reduction from baseline PANSS total score and CGI-C score of <= 2 (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder).|Week 6 LOCF End Point|Intent-to-Treat|||participants|||Number
1263045|NCT00412373|Secondary|Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder|"The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to No change. Ratings of <4 are equivalent to improvement and ratings of > 4 are equivalent to worsening. Higher scores indicate worsening."|Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263046|NCT00412373|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Higher scores indicate worsening."|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263048|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263049|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263050|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263051|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263052|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263053|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263054|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263055|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
1263056|NCT00412373|Primary|Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.|The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.|||points on a scale||Standard Deviation|Mean
1263057|NCT00412373|Primary|Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.|||points on a scale||Standard Deviation|Mean
1263058|NCT00412360|Secondary|Number of Participants With Engraftment Syndrome||Day 100 post-transplant|Transplanted participants|||Participants|||Count of Participants
1288253|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24||Month 24||||L||Standard Error|Mean
1263060|NCT00412360|Secondary|Percentage of Participants With Relapse|Relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features. Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation.|1 year post-randomization|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
1263061|NCT00412360|Secondary|Number of Infections Per Participant||2 years post-randomization|Transplanted participants|||Participants|||Count of Participants
1263062|NCT00412360|Secondary|Percentage of Participants With Chronic GVHD|Incidences of chronic GVHD will be graded per Shulman et al. 1980. This reference categorizes chronic GVHD as either limited or extensive. For this outcome, participants developing either type are considered to have a chronic GVHD event.|1 year post-randomization|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
1263063|NCT00412360|Secondary|Percentage of Participants With Acute Graft-versus-host Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 100 post-randomization|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
1263064|NCT00412360|Secondary|Time to Neutrophil and Platelet Engraftment|Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.|2 years post-transplant|Transplanted participants|||days||Full Range|Median
1263065|NCT00412360|Secondary|Percentage of Participants With Neutrophil and Platelet Engraftment|Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10^6/liter for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.|Days 42 and 100|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
1263066|NCT00412360|Secondary|Percentage of Participants With Disease-free Survival|Disease-free survival is defined as survival without relapse of the primary disease.|1 year post-randomization||||percentage of participants||95% Confidence Interval|Number
1263067|NCT00412360|Primary|Percentage of Participants With Overall Survival|Overall survival is defined as survival of death from any cause.|1 year post-randomization||||percentage of participants||95% Confidence Interval|Number
1263068|NCT00412243|Primary|Maximum Tolerated Dose for Cyclophosphamide (MTD)|MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle|First 14 days of each cycle|MTD calculated with first 8 study participants.|||mg/m^2|||Number
1263069|NCT00412217|Secondary|Overall Survival (OS)|OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.|From inclusion in the study until death from any cause (maximum up to 3 years overall)|ITT Population.|||months||95% Confidence Interval|Median
1263070|NCT00412217|Secondary|Number of Participants Who Died|The number of participants who died from any cause was reported.|From inclusion in the study until death from any cause (maximum up to 3 years overall)|ITT Population.|||participants|||Number
1263071|NCT00412217|Primary|Time to Progression (TTP)|Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.|From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)|ITT Population.|||months||95% Confidence Interval|Median
1263072|NCT00412217|Primary|Number of Participants With Disease Progression|Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.|From inclusion in the study until disease progression (maximum up to 3 years overall)|ITT Population.|||participants|||Number
1263073|NCT00412113|Primary|Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk|Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.|Week 6, baseline|The full analysis set of all randomized subjects who took at least one dose of study drug and had any post-baseline efficacy assessment|||score on scale||Standard Deviation|Least Squares Mean
1263074|NCT00412113|Secondary|Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.|Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||score on scale||Standard Deviation|Least Squares Mean
1263075|NCT00412113|Secondary|Change From Baseline in Triglycerides (TG) at Week 6.|Mean change at observation minus mean baseline.|Week 6 , baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
1263076|NCT00412113|Secondary|Change From Baseline in Total Cholesterol (TC) to Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||mg/dL||Standard Deviation|Mean
1263077|NCT00412113|Secondary|Change From Baseline in HDL at Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
1263078|NCT00412113|Secondary|Change From Baseline in LDL at Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
1263079|NCT00412113|Secondary|Change From Baseline in Triglycerides (TG) to Week 4.|Mean change at observation minus baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
1263080|NCT00412113|Secondary|Change in Total Cholesterol (TC) From Baseline to Week 4.|Mean change at observation minus baseline.|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
1263081|NCT00412113|Secondary|Change From Baseline in High Density Lipoprotein (HDL) at Week 4.|Mean change at observation minus baseline.|Week 4, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||mg/dL||Standard Deviation|Mean
1263082|NCT00412113|Secondary|Change From Baseline in LDL at Week 4.|Change: mean of observation minus mean at baseline.|Week 4, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||mg/dL||Standard Deviation|Mean
1263083|NCT00412113|Secondary|Change From Baseline to Week 6 in Pulse Rate|Mean at observation minus mean at baseline|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||bpm||Standard Deviation|Mean
1263084|NCT00412113|Secondary|Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)|Change from mean at observation minus mean at baseline|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mmHg||Standard Deviation|Median
1263085|NCT00412113|Secondary|Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)|Mean change at observation minus mean baseline.|Week 6, baseline|Full analysis set: all randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||mmHg||Standard Deviation|Mean
1263086|NCT00412113|Secondary|Change From Baseline to Week 4 in Pulse Rate|Mean at observation minus mean at baseline measured in beats per minute (bpm).|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||bpm||Standard Deviation|Mean
1263087|NCT00412113|Secondary|Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)|Mean at observation minus mean at baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mmHg||Standard Deviation|Mean
1263088|NCT00412113|Secondary|Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).|Mean at observation minus mean at baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mmHg||Standard Deviation|Mean
1263089|NCT00412113|Secondary|Subjects With BP < 140/90 mmHg at Week 6|Subjects achieving BP goal of <140/90 mmHg at week 6|Week 6|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||participants|||Number
1263090|NCT00412113|Secondary|Subjects With BP < 140/90 mmHg at Week 4|Subjects achieving BP goal of <140/90 mmHg at week 4|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS|||participants|||Number
1263091|NCT00412113|Secondary|Subjects With LDL-C < 100 mg/dL at Week 6|Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6.|Week 6|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||participants|||Number
1263092|NCT00412113|Secondary|Subjects With LDL-C < 100 mg/dL at Week 4|Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4.|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||participants|||Number
1263093|NCT00412113|Secondary|Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.|Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6.|Week 6|Full analysis set (FAS).|||participants|||Number
1263094|NCT00412113|Secondary|Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.|Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4.|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||participants|||Number
1263095|NCT00412113|Secondary|Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4|Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4.|Week 4|Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||participants|||Number
1263096|NCT00412113|Primary|Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6|Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)|Week 6|Full analysis set (FAS) is all randomized subjects who take at least one dose of study drug and and have any post-baseline efficacy assessments.|||participants|||Number
1263097|NCT00412087|Secondary|Parathyroid Hormone at Visit 7|Intact parathyroid hormone at Visit 7, one month prior to delivery|7 months|There was 1 subject in the 2000 IU group and 3 subjects in the 4000 IU group missing PTH measurements.|||pg/mL||Standard Deviation|Mean
1263098|NCT00412087|Primary|25-hydroxyvitamin D at Visit 7|25-hydroxyvitamin D at Visit 7, one month prior to delivery|7 months||||ng/mL||Standard Deviation|Mean
1263099|NCT00412074|Secondary|Infant Health Status - Vitamin D Deficiency|Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7|to 7 months of age|The number of infants analyzed in each group was fewer than the number of subjects analyzed for the maternal outcomes - though blood draws were attempted for all infants at Visit 7, we were unable to obtain blood from 14 infants in the 400 IU arm, 7 infants in the 2400 IU arm, and 14 infants in the 6400 IU arm.|||percentage of infants|||Number
1263100|NCT00412074|Secondary|Maternal Health Status - Vitamin D Deficiency|Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7|to 7 months postpartum||||percentage of participants|||Number
1263101|NCT00412074|Primary|25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery||to 7 months postpartum||||ng/mL||Standard Deviation|Mean
1263102|NCT00412061|Secondary|Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)|"Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be ‘Elevated’; otherwise considered as Non-elevated."|If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data.|||Months||95% Confidence Interval|Median
1263103|NCT00412061|Secondary|Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From first day of treatment up to 28 days after last day of treatment in double blind|The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.|||Patients|||Number
1263104|NCT00412061|Secondary|Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From first day of treatment up to 28 days after last day of treatment in double blind|The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.|||Patients|||Number
1263105|NCT00412061|Secondary|Overall Survival Using Kaplan-Meier Methodology|Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.|Months 12, 24, 36, 48|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.|||Percentage of Participants||95% Confidence Interval|Number
1263106|NCT00412061|Secondary|Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level|5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as ‘High’ if they exceeded the median value, and ‘Low’ if they were lower than or equal to the median.|If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.|||Months||95% Confidence Interval|Median
1263107|NCT00412061|Secondary|Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)|The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.|||Percentage of patients||95% Confidence Interval|Number
1263108|NCT00412061|Primary|Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review|Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1263109|NCT00411788|Secondary|To Evaluate the Use of FDG-PET as an Early Predictor of Response to the Combination of Rapamycin and Trastuzumab, be Assessing Changes in Glucose Metabolism and Cell Viability Between Pre- and Post-treatment||Upon completion of study|This outcome measure was not collected nor analyzed due to study closure and low sample size.||||||
1263110|NCT00411788|Secondary|To Determine if Currently Available RNA Expression Profiles Associated With Response to Herceptin Will be Predictably Altered in Tumors Treated With Trastuzumab and Rapamycin, and Will Further Elucidate the Mechanism of Synergy of These Two Agents||study completion|This outcome measure was not collected nor analyzed due to study closure and low sample size.||||||
1263111|NCT00411788|Secondary|To Determine Pre and Post Therapy Changes in the Levels, Phosphorylation Status and/or Subcellular Localization of the Affected Signal Transduction Molecules HER2, Akt, S6K and 4EBP1 in Blood and Tumor Tissues|These data were not collected and analyzed as described here in the initial protocol submission.|Upon completion of study|||||||
1263112|NCT00411788|Secondary|Incidence of Cardiac Dysfunction|"This safety measure was used to determine the number of patients treated with the combination of trastuzumab and rapamycin with cardiac dysfunction.~This secondary outcome measure was reworded from its original version when results were entered."|study completion up to 58 weeks|Safety population consisting of 9 of 11 patients that received treatment following first dose.|||participants|||Number
1263113|NCT00411788|Secondary|Objective Response Rate (ORR)|"ORR was determined according to RECIST criteria, duration of response, and time to progression in patients with HER2 overexpressing advanced breast cancer receiving trastuzumab and rapamycin. The objective response rate (ORR) by response evaluation criteria (RECIST) 1.0, duration of response, safety, and pharmacodynamic endpoints.~This secondary outcome measure was reworded from its original submission when results were entered."|study completion up to 58 weeks||||participants|||Number
1263114|NCT00411788|Primary|Proportion of Patients Who Are Progression-free (CR, PR and Stable Disease)|"To determine the clinical activity of oral daily rapamycin administered in combination with weekly intravenous trastuzumab in patients with HER2 overexpressing advanced breast cancer, the primary outcome is to determine the proportion of patients who are progression-free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD).who are progression free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD). Response objectives assessed using response evaluation criteria (RECIST) 1.0~This primary outcome was reworded from its original format when results were entered."|16 weeks|Nine patients were evaluable for response assessment. Two patients withdrew from study before first response assessment (one for noncompliance and the other for toxicity).|||participants|||Number
1263115|NCT00411762|Secondary|Median Overall Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 100 weeks|20 subjects received 2 cycles or more and were evaluated for response|||weeks||Full Range|Median
1263116|NCT00411762|Primary|Median Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 100 weeks|20 subjects received 2 cycles or more and were evaluated for response|||weeks||Full Range|Median
1263117|NCT00411749|Secondary|HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series|Month 30 HPV cLIA Geometric Mean Titers by vaccine group.|24 month after completed vaccination series (Month 30)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 30 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
1263118|NCT00411749|Primary|Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
1263119|NCT00411749|Primary|Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
1263120|NCT00411749|Primary|Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
1263121|NCT00411749|Primary|Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group.~The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
1263122|NCT00411671|Secondary|Tumor Response Measured Every 8-weeks|Tumor responses was measured according to RECIST criteria. Tumor responses were defined as: Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|At baseline and then every 8 weeks until treatment discontinuation.|Of the enrolled participants, only 98 were evaluable for the outcome.|||participants|||Number
1263123|NCT00411671|Secondary|Progression-Free Survival|The Progression-Free Survival (PFS) was measured from date of randomization until progressive disease (PD) or death respectively.|From date of randomization until PD or death respectively, up to 3 years|Of the enrolled participants, only 98 were evaluable for the outcome.|||months||Full Range|Median
1263124|NCT00411671|Primary|8-Week Disease Control Rate|The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to 8 weeks|Of the enrolled participants, 98 were evaluable for the outcome.|||percentage of participants|||Number
1263125|NCT00411645|Secondary|Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment|Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of VP 44469, a metabolite of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.|12 hours post-dose after 1 and 4 weeks of treatment|The PK population, defined as those participants in the ITT population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.|||μg/mL||Standard Deviation|Mean
1263126|NCT00411645|Secondary|Plasma Concentration of Maribavir During Treatment|Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.|12 hours post-dose after 1 and 4 weeks of treatment|The pharmacokinetic (PK) population, defined as those participants in the ITT population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.|||μg/mL||Standard Deviation|Mean
1263127|NCT00411645|Secondary|Number of Participants Who Died Within 12 Months Post-Transplantation||Through 12 months post-transplant (Days 1 to 100, 6 months, and 12 months post-transplant)|The ITT-S population, defined as participants in the ITT population who received at least one dose of study drug.|||participants|||Number
1263128|NCT00411645|Secondary|Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD)|Analysis of chronic GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for chronic GVHD. The percentage reported is for the occurrence of any grade of chronic GVHD.|Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)|The ITT-S population, defined as participants in the ITT population who received at least one dose of study drug.|||percentage of participants|||Number
1263129|NCT00411645|Secondary|Percent of Participants With Acute Graft-Versus-Host Disease (GVHD)|Analysis of acute GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for acute GVHD. The percentage reported is for the occurrence of any grade of acute GVHD.|Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)|The ITT Safety (ITT-S) population, defined as participants in the ITT population who received at least one dose of study drug.|||percentage of participants|||Number
1263130|NCT00411645|Secondary|Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|12 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
1265635|NCT00394654|Secondary|Observed Maximum Sputum Concentration (Cmax)|Cmax of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1263131|NCT00411645|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|100 days post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
1263132|NCT00411645|Secondary|Number of Participants With Investigator-determined CMV Disease|CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|Through 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant)|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
1263133|NCT00411645|Secondary|Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay or (2) CMV DNA polymerase chain reaction (PCR). CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||days||Inter-Quartile Range|Median
1263134|NCT00411645|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
1263135|NCT00411645|Primary|Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The Intent-to-Treat (ITT) population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
1263136|NCT00411619|Secondary|Overall Reduction in SEGA Tumor Volume.||During the entire study||||participants|||Number
1263137|NCT00411619|Primary|Number With Observed Adverse Side Effects||During the entire study||||participants|||Number
1263138|NCT00411554|Secondary|Change From Baseline in 2 Hour Postprandial Glucose at Week 12|Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
1263174|NCT00411151|Secondary|Overall Survival (OS)|OS is defined as the time from the first dose of trial medication to date of death due to any cause.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.|||Days||95% Confidence Interval|Median
1263139|NCT00411554|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
1263140|NCT00411554|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for major protocol violations.|||Percent||95% Confidence Interval|Least Squares Mean
1263141|NCT00411463|Secondary|Number of Participants With a Response|Number of participants with response defined as an average of 50% (or greater) reduction in the subject’s baseline HRSD-25 score over three consecutive weeks and a current YMRS score ≤ 10|Week 12||||Participants|||Count of Participants
1263142|NCT00411463|Secondary|Descriptive Measures of the Feasibility of IPSRT-BPII|Feasibility was assessed by ability to enroll, randomize, and retain participants in this trial. Completion of the study was used as evidence of feasibility.|Week 12||||Participants|||Count of Participants
1263143|NCT00411463|Secondary|Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)|The total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.|Baseline and Week 12||||scores on Q-LES-Q scale||95% Confidence Interval|Least Squares Mean
1263144|NCT00411463|Primary|Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10|Overall response rates (defined as greater than or equal to 50% reduction in depression scores without an increase in mania scores) were 29% (n=4) in the IPSRT group and 27% (n=3) in the quetiapine group. HRSD-25 scores are based on first 17 responses. Eight items are scored on a 5-pt scale, from 0 (not present) to 4 (severe.) Other nine items on the assessment are scored from 0-2. The higher the score on the HRSD-25, the worse the outcome is considered to be. A score of 0-7 is considered to be normal; 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression, and any score greater than or equal to 23 indicates very severe depression. The YMRS is an 11 point assessment. There are 4 items assessed on a scale ranging from 0 to 8 and the other 7 items are graded on a 0 to 4 scale. As with the HRSD, the higher the score on the YMRS indicates the presence of more or more severe manic symptoms and is associated with a worse outcome.|Week 12||||participants|||Number
1263145|NCT00411450|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|The immunogenicity of panitumumab was evaluated using 2 different screening immunoassays for the detection of anti-panitumumab antibodies: an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA; detecting high-affinity antibodies) and a Biacore® biosensor immunoassay (detecting both high and low-affinity antibodies). When either of the 2 screening assays yielded a positive result, that particular sample was subjected to an in vitro bioassay for the detection of neutralizing antibodies.|Prior to first dose and 28 days after the last dose of second-line treatment|Safety Analysis Set with baseline anti-panitumumab antibody testing sample available|||participants|||Number
1263146|NCT00411450|Secondary|Number of Participants With Grade 4 Laboratory Toxicities|Laboratory toxicities were graded according to CTCAE version 3.|From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.|Safety Analysis Set|||participants|||Number
1263147|NCT00411450|Primary|Time to Response|Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Responders in the Tumor Response Analysis Set|||weeks||Full Range|Median
1263148|NCT00411450|Primary|Time to Progression|Time to progression is defined as the time from study Day 1 to the date of observed disease progression. Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set|||weeks||95% Confidence Interval|Median
1263149|NCT00411450|Primary|Time to Treatment Failure|Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause. Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Primary Analysis Set|||weeks||95% Confidence Interval|Median
1263150|NCT00411450|Primary|Overall Survival|Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set|||weeks||95% Confidence Interval|Median
1263169|NCT00411216|Primary|Change in Visual Acuity During Head Movement From Baseline to Discharge|"visual acuity is measured using a computerized system first with the head stationary and then with the head moving in yaw plane. Head velocity is measured using a rate sensor and optotype is displayed only when head velocity is between 120 and 180 degrees per second.~The change in visual acuity was calculated from subtracting the discharge measurement from the baseline measurement (pre-intervention)."|pre-intervention and at discharge||||LogMAR||Standard Deviation|Mean
1263170|NCT00411151|Secondary|Safety and Tolerability: Adverse Events in ≥10% of Patients||one year|Safety population comprises all patients registered.|||Participants|||Number
1263151|NCT00411450|Primary|Duration of Response|Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator). Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Responders of Tumor Response Analysis Set|||weeks||95% Confidence Interval|Median
1263152|NCT00411450|Primary|Disease Control Rate at Weeks 17 and 25|The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.|Week 17 and Week 25|Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
1263153|NCT00411450|Primary|Progression-free Survival Time|Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause. Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set|||weeks||95% Confidence Interval|Median
1263154|NCT00411450|Primary|Progression-free Survival Rate at Weeks 17 and 25|"The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria.~PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment."|Week 17 and Week 25|Primary Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, and who had valid KRAS mutation status data available)|||percent probability||95% Confidence Interval|Number
1263155|NCT00411450|Primary|Best Response During Second-Line Treatment|"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders.~CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions."|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
1263156|NCT00411450|Secondary|Number of Participants With Adverse Events|The severity of adverse events (AEs) was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, except for panitumumab related skin toxicities, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The relationship of each adverse event to the panitumumab and/or FOLFIRI regimen was assessed by the investigator. A serious adverse event was defined as an adverse event that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.|From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.|Safety analysis set (all participants who provided informed consent prior to the initiation of any study specific procedure and who received at least 1 dose of panitumumab)|||participants|||Number
1263157|NCT00411450|Primary|Objective Response Rate at Weeks 17 and 25|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.|Week 17 and Week 25|Tumor Response Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, who had valid KRAS mutation status data available and with at least 1 uni-dimensionally measurable lesion per the local investigator)|||percentage of participants||95% Confidence Interval|Number
1263158|NCT00411411|Secondary|Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose)|Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose). Patients will be followed for 12 weeks with three examinations; before, during and after the treatment|12 weeks|||||||
1263159|NCT00411411|Primary|Restoration of the Insulinotropic Effect of GIP|Restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose. Patients will be followed for 12 weeks with examinations after 1 and after 12 weeks of treatment.|12 weeks||||pM x 120 min||Standard Error|Mean
1263175|NCT00411151|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose of trial medication to first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.|||Days||95% Confidence Interval|Median
1263176|NCT00411151|Primary|Objective Response Rate (ORR)|The primary endpoint is the ORR within the first 6 treatment cycles, defined as the percentage of participants with a confirmed reduction in tumor size fulfilling the criteria for complete or partial response (CR or PR) according to RECIST. CR=disappearance of all target lesions, PR=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.|||Participants (%)||95% Confidence Interval|Number
1263177|NCT00411086|Secondary|Overall Response (OR) Rate|OS defined as percentage of participants alive at a certain period following start of chemotherapy treatment.|3 Months||||percentage of participants|||Number
1263178|NCT00411086|Secondary|Median Progression-Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression; and, for PFS time calculated from chemo start date to progression date or death date, whichever happened first. Patients were censored at the last follow-up date if neither progression nor death occurred. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas. The Kaplan-Meier method was used for time-to-event analysis including PFS.|3 years||||Months||95% Confidence Interval|Median
1263179|NCT00411086|Primary|Complete Response Rate|"Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities [e.g., lactate dehydrogenase (LDH)] definitely assignable to NHL.~Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas."|12 weeks (3 months)|Response includes unconfirmed CRs.|||percentage of participants|||Number
1263180|NCT00410904|Secondary|Overall Survival|Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.|The time from start of treatment to time of death, assessed up to 4 years||||months||95% Confidence Interval|Median
1263181|NCT00410904|Secondary|Progression-free Survival|Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|The duration of time from start of treatment to time of progression, assessed up to 4 years||||months||95% Confidence Interval|Median
1263182|NCT00410904|Primary|Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab.|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT:~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)"|Up to 4 years||||participants|||Number
1263183|NCT00410891|Primary|Positive Culture|The percentage of patients with a positive bacterial culture following administration of study treatment is presented.|Study day 1, assessed following administration of study treatment||||percentage of patients|||Number
1263184|NCT00410826|Secondary|Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 3 months for up to 5 years||||participants|||Number
1263185|NCT00410826|Secondary|Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm||30 days after the completion of therapy|||||||
1263186|NCT00410826|Primary|Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm|Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).|12 weeks after the completion of therapy||||percentage of participants|||Number
1263187|NCT00410813|Secondary|Mean Patient-reported Pain|"Patient's rating of worst pain experienced between prestudy and week 24. Changes of >=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning."|Baseline, 8, 16, and 24 weeks|All patients with non-missing values were analyzed|||units on a scale||Standard Deviation|Mean
1263188|NCT00410813|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 2 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1263189|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- TRAP|Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||U/L||Standard Deviation|Mean
1263190|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- OPG|Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||pmol/L||Standard Deviation|Mean
1263192|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time|Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||pg/mL||Standard Deviation|Mean
1263193|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- BAP|Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||ug/L||Standard Deviation|Mean
1263194|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- NTx|Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||nM BCE||Standard Deviation|Mean
1263195|NCT00410813|Secondary|Circulating Tumor Cells (CTC) Response Rate|CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (>= 5 cells/7.5 ml), whose CTC level drops to < 5.|Up to 4 weeks|Treatment arms are combined in this analysis. Only eligible patients evaluated at both baseline and at 4 weeks were included. Patients analyzed for CTC response only includes patients who had elevated CTCs at baseline.|||participants|||Number
1263196|NCT00410813|Secondary|MUC-1 Antigen Response|MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 <= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression.|at 4, 8, 16, and 24 weeks|MUC-1 Inadequate Assessment, response unknown: MUC-1 response has not been adequately assessed at indicated timepoints.||||||
1263197|NCT00410813|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 2 years|All eligible patients|||participants|||Number
1263198|NCT00410813|Primary|Progression-free Survival|RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.|Up to 2 years|All eligible patients were included in this analysis.|||weeks||95% Confidence Interval|Median
1263199|NCT00410761|Secondary|Time to Worsening of Pain (TWP)|TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.|During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.||||Weeks|||Number
1263200|NCT00410761|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA)|Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.|Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up||||Participants|||Number
1263201|NCT00410761|Secondary|Biochemical Response Calcitonin (CTN)|Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.|Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up||||Participants|||Number
1263202|NCT00410761|Secondary|Overall Survival (OS)|As data was immature at data cut off, number of death events is quoted|Number of deaths since randomisation||||Participants|||Number
1263203|NCT00410761|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent|DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median|||Months||95% Confidence Interval|Median
1263204|NCT00410761|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 12 weeks|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent||||Participants|||Number
1271386|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4|Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose|After 4 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1263205|NCT00410761|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE."|RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.||||Participants|||Number
1263206|NCT00410761|Primary|Progression-Free Survival(PFS)|Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.||||Months||95% Confidence Interval|Median
1263207|NCT00410605|Secondary|Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at 3 Months Post-baseline|A Wilconxon signed-rank test conducted to determine if biomarker levels differed between baseline levels and those after three full cycles of treatment for all patients.|Up to Course 4 Day 1 (3 Months Post-baseline)||||mg per liter||Standard Deviation|Mean
1263208|NCT00410605|Secondary|Local Cytokine Milieu Using Tissue Micro Arrays of Bone Marrow Biopsy Specimens||Up to 5 years|Outcome measure data were not collected.||||||
1263209|NCT00410605|Secondary|Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at Baseline|A Wilconxon signed-rank test conducted to determine if biomarker levels differed between baseline levels and those after three full cycles of treatment for all patients.|Baseline||||mg per liter||Standard Deviation|Mean
1263210|NCT00410605|Secondary|Toxicity and Tolerability of the Bevacizumab and Lenalidomide Combination|Adverse events/toxicities were collected during regular clinical visits. Confidence intervals for the estimate of the true number of patients suffereing from grade 3 or 4 toxicities per common terminology criteria were calculated using the Wilson interval. Ninety-five percent confidence intervals for the proportions of patients with complications (grade 3 or higher toxicities) were constructed.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1263211|NCT00410605|Primary|Progression Free Survival (Time to Progression)|Patient response to the treatment were determined by the definitions for complete response, partial response, marginal response, stable disease, and progressive disease outlined by IMBTR/ABMTR (Blade criteria). Progression free survival was summarized using point estimates of the median time to progression and associated 95% confidence intervals. The data was presented graphically using Kaplan-Meier plots. Exploratory analysis, including multivariate Cox regression with demographic variables and markers of myeloma activity as covariates was performed.|up to five years||||months||95% Confidence Interval|Median
1263212|NCT00410605|Primary|Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bevacizumab and Lenalidomide|Patient response to the treatment were determined by the definitions for complete response, partial response, marginal response, stable disease, and progressive disease outlined by IMBTR/ABMTR (Blade criteria). Responses were analyzed by descriptive statistics and summarized in tabular format (frequency tables). Furthermore, two-sided 95% confidence intervals for the proportions of subjects with a confirmed anti-tumor response were computed using the method proposed by Chang, which takes into account the multiplicity problem associated with the two-stage testing procedure. The objective response rate was estimated by using Whitehead's bias-adjustment approach.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1263213|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score|"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
1263214|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score|"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions each on a 1-4 scale (larger scores correspond to less quality of life). The total symptom score ranges from 19 - 76.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
1263215|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score|"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MaleLUTS questionnaire which consists of 13 symptom bother questions each on a 0-10 scale (larger scores correspond to worse outcomes). The total bother score ranges from 0 to 130.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
1288254|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18||Month 18||||L||Standard Error|Mean
1263216|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score|"Male lower urinary tract symptoms were assessed by the ICIQ MaleLUTS questionnaire which consists of 13 questions each on a 0-4 scale (larger scores correspond to worse conditions). The total symptom score ranges from 0 to 52.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
1263217|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition|"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||mL||Standard Error|Least Squares Mean
1263218|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. The analysis only includes patients with >0 incontinence episodes at baseline. End of treatment (EOT) includes patients who didn't complete Week 12.|||Incontinence episodes||Standard Error|Least Squares Mean
1263219|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours|"For each micturition and/or incontinence episode in the 3 days preceding the clinic visit, participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild Urgency, could postpone passing water for as long as necessary; 2: Moderate Urgency, could postpone passing water for a short while; 3: Severe Urgency, could not postpone passing water; 4: Urge Incontinence, leaked before reaching the toilet.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||Urgency episodes||Standard Error|Least Squares Mean
1263220|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours|"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||micturitions||Standard Error|Least Squares Mean
1263221|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)|"The patient perception of bladder condition (PPBC) asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
1263222|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
1263550|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||micromole/Liter||Standard Deviation|Mean
1263223|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
1263224|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
1263225|NCT00410514|Secondary|Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests|Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.|From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).|The Safety Analysis set included all participants who received at least one dose of study drug.|||participants|||Number
1263226|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)|"Healthy micturitions (urinations) result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding and was assessed using abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Safety Analysis set included all participants who received at least one dose of study drug. End of treatment (EOT) analysis includes the last assessment for patients who did not complete the Week 12 visit; N indicates the number of patients included at each time point.|||mL||Standard Error|Least Squares Mean
1263227|NCT00410514|Secondary|Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)|"Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.|||Percent voiding efficiency||Standard Error|Least Squares Mean
1263228|NCT00410514|Primary|Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)|"Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.|||cmH2O||Standard Error|Least Squares Mean
1263229|NCT00410514|Secondary|Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)|"The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.|||Scores on a scale||Standard Error|Least Squares Mean
1263240|NCT00410410|Primary|OL; Number of Participants With Marked Hematology Laboratory Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263230|NCT00410514|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|"Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.|||mL/sec||Standard Error|Least Squares Mean
1263231|NCT00410488|Primary|Palonosetron Response Rate in the 10 Day Study Cycle|Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.|10 days||||percentage of participants|||Number
1263232|NCT00410423|Primary|Complete Response Rate to 1.3mg/m^2 of Bortezomib With Mitoxantrone and Etoposide in Phase II|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.~The percentage of participants that experienced complete response will be reported."|Up to 7 years||||percentage of participants|||Number
1263233|NCT00410423|Primary|Number of Participants With Dose Limiting Toxicity in Phase I|Dose limiting toxicity (DLT) is defined as grade-3 toxicity definitely related to bortezomib or grade-4 toxicity probably or definitely related to bortezomib.|30-90 days||||Participants|||Count of Participants
1263234|NCT00410410|Secondary|OL; Number of Participants Using Corticosteroids During OL|Participants taking oral corticosteroids (equivalent of ≤ 30 mg prednisone daily) must have met minimum treatment duration at entry into IP and had stable dose for ≥2 weeks prior to entry into the IP.|Day OL-1 through Day OL-729|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of corticosteroid use was not conducted for the OL as planned.||||||
1263235|NCT00410410|Secondary|OL; Number of Participants With Abatacept-Induced Antibodies|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."|||participants|||Number
1263236|NCT00410410|Secondary|OL; Number of Participants With Clinical Response or Clinical Remission Upon Retreatment With Abatacept Among Those Who Received Abatacept in the IP or MP Period|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Clinical remission = Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Change from Baseline= post-Baseline - Baseline value.|Last Study Visit (Day OL-729)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical efficacy upon retreatment with abatacept among participants who received study drug during the IP or MP was not conducted for the OL as planned.||||||
1263237|NCT00410410|Secondary|OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) During OL|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Open-Label Period (Day OL-1 through Day OL-729)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of mucosal healing was not conducted for the OL as planned.|||participants|||Number
1263238|NCT00410410|Primary|OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263239|NCT00410410|Primary|OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263324|NCT00410202|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 96|Participants who received at least 1 dose of study therapy were analyzed. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263241|NCT00410410|Secondary|OL; Number of Participants With Clinical Remission Over Time|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the efficacy analyses of the OL. Number of Participants Analyzed=all participants in OL; n=number of evaluable participants.|||participants|||Number
1263242|NCT00410410|Secondary|OL; Number of Participants With Clinical Response Over Time|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the efficacy analyses of the OL. Number of Participants Analyzed=all participants in OL; n=number of evaluable participants.|||participants|||Number
1263243|NCT00410410|Primary|OL; Number of Participants With Physical Examination Findings|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day OL-1 through Day OL-729|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.||||||
1263244|NCT00410410|Secondary|MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-85 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263245|NCT00410410|Secondary|MP; Number of Participants With Marked Hematology Laboratory Abnormalities|High=greater than ULN, Low=lower than LLN. LLN/ULN= HGB: >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; PLT: <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; GGT: >2 x ULN; Bilirubin: >2 x ULN; BUN: >2 x BL; Na: <0.95 x LLN/ >1.05 x ULN; K: <0.9 x LLN/ >1.1 x ULN; Ca: <0.8 x LLN/>1.2 x ULN|Day IP-85 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263246|NCT00410410|Secondary|MP; Number of Participants With Physical Examination Findings|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day IP-85 through Day MP-365|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.||||||
1263247|NCT00410410|Secondary|MP; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day MP-1 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263248|NCT00410410|Secondary|MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day MP-1 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263265|NCT00410410|Secondary|IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN;|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263249|NCT00410410|Secondary|MP; Number of Participants With Abatacept-Induced Antibodies|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants not entering OL: All measurements starting after Day MP-1 (including follow-up visits). For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1).|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."|||participants|||Number
1263250|NCT00410410|Secondary|MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of mucosal healing in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||||||
1263251|NCT00410410|Secondary|MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance =inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical remission in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||||||
1263252|NCT00410410|Secondary|MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical response in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||||||
1263253|NCT00410410|Secondary|MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with PGA subscores indicating mild disease (≤1) was not conducted for the MP as planned.||||||
1263254|NCT00410410|Secondary|MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with stool frequency subscores indicating mild disease (≤1) was not conducted for the MP as planned.||||||
1263255|NCT00410410|Secondary|MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with rectal subscores indicating mild disease (≤1) was not conducted for the MP as planned.||||||
1263256|NCT00410410|Secondary|MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12|Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.||||||
1263257|NCT00410410|Secondary|MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36)|The SF-36 is a validated instrument to measure health-related quality of life across multiple disease states. Individual subscale scores and 2 summary scores are calculated: (1) physical component summary (PCS) which includes physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS) which includes vitality, social functioning, role-emotional, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight, with values ranging from worse health (0) to best health (100).|Day MP-365|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.||||||
1263258|NCT00410410|Secondary|MP; Mean Change From Baseline to Month 12 in IBDQ|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Day MP-365|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.||||||
1263259|NCT00410410|Secondary|MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12|Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.||||||
1263260|NCT00410410|Secondary|MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Month 6 (Day MP-169), Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants in clinical remission at both Month 6 and Month 12 was not conducted for the MP as planned.||||||
1263261|NCT00410410|Secondary|MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263262|NCT00410410|Secondary|MP; Number of Participants in Clinical Remission at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263263|NCT00410410|Secondary|IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85). For participants treated in OL directly after IP: Day IP-1 to Day OL-1. For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."|||participants|||Number
1263264|NCT00410410|Secondary|IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263292|NCT00410384|Secondary|Mean Change in Physician's Global Assessment (PGA) at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Scores on a 3-point scale||Standard Error|Mean
1288255|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18||Month 18||||L||Standard Error|Mean
1263266|NCT00410410|Secondary|IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263267|NCT00410410|Secondary|IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263268|NCT00410410|Secondary|IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263269|NCT00410410|Secondary|IP; Number of Participants With Physical Examination Findings: IP1C + IP2C|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day IP-1 through Day IP-85|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.||||||
1263270|NCT00410410|Secondary|IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263271|NCT00410410|Secondary|IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
1263272|NCT00410410|Secondary|IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.|||participants|||Number
1263273|NCT00410410|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the safety analyses of the Open-Label Extension phase.|||participants|||Number
1263293|NCT00410384|Secondary|Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.||Baseline, 52 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Percentage of participants|||Number
1263325|NCT00410202|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263274|NCT00410410|Primary|Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day OL-1 through the end of the OL|All participants who received at least 1 infusion of open-label study medication at any time were included in the safety analyses of the Open-Label Extension phase.|||participants|||Number
1263275|NCT00410410|Secondary|IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|"The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance~=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks."|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.|||participants|||Number
1263276|NCT00410410|Primary|Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263277|NCT00410410|Secondary|IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.|||participants|||Number
1263278|NCT00410410|Secondary|IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With Clinical Response At Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.|||participants|||Number
1263279|NCT00410410|Secondary|IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263280|NCT00410410|Secondary|IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263281|NCT00410410|Secondary|IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1264526|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Triglycerides||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1263282|NCT00410410|Secondary|IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Baseline (Day IP-1), Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||units on a scale||Standard Error|Mean
1263283|NCT00410410|Secondary|IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Baseline|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||units on a scale||Standard Deviation|Mean
1263284|NCT00410410|Secondary|IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263285|NCT00410410|Secondary|IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263286|NCT00410410|Secondary|IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263287|NCT00410410|Secondary|IP; Baseline Mayo Score: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Baseline|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||units on a scale||Standard Deviation|Mean
1263288|NCT00410410|Primary|Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C)|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Week 12 (Day IP-85)|All participants who were randomized and received at least one infusion of study medication (Intent To Treat Population, ITT) were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
1263289|NCT00410384|Other Pre-specified|Adverse Event (AE) Overview|SEE ALSO ADVERSE EVENT RESULTS SECTION|Up to 80 Weeks||||Percentage of participants|||Number
1263290|NCT00410384|Secondary|Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52||Baseline, Weeks 40-52|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day.|||Percentage of participants|||Number
1263291|NCT00410384|Secondary|Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.|The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient’s response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.|Baseline, 24 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Scores on a scale||Standard Error|Mean
1288256|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12||Month 12||||L||Standard Error|Mean
1263294|NCT00410384|Secondary|SRI Response Rate at Week 76|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 76 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 76 data.|||Percentage of participants|||Number
1263295|NCT00410384|Primary|SLE Responder Index (SRI) Response Rate at Week 52|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 52 Weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.|||Percentage of participants|||Number
1263296|NCT00410280|Secondary|Number of Participants With Antibodies to IMA-638||Baseline up to Day 168|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||participants|||Number
1263297|NCT00410280|Secondary|Serum Decay Half-Life (t1/2) for IMA-638|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||days||Standard Deviation|Mean
1263298|NCT00410280|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||mcg*hr/mL||Standard Deviation|Mean
1263299|NCT00410280|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638|Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-t).|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
1263300|NCT00410280|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638||Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||days||Standard Deviation|Mean
1263301|NCT00410280|Secondary|Maximum Observed Serum Concentration (Cmax) for IMA-638||Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||microgram/milliliter(mcg/mL)||Standard Deviation|Mean
1263302|NCT00410280|Secondary|Protein Expression in Sputum and Blood|Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.|Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112|Data for this outcome measure w as not analyzed because the study w as stopped early after interim analysis and only safety and key efficacy analyses w ere performed.||||||
1263303|NCT00410280|Secondary|Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood|Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.|Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112|Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.||||||
1263304|NCT00410280|Secondary|Blood Levels of Interleukin-13 (IL-13)||Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.||||||
1263305|NCT00410280|Secondary|Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34).|Baseline, Day 8, 13, 21, 34, 56, 84, 168|"ITT population included all randomized participants who received at least 1 dose administration of the test article. Here, n signifies participants evaluated for this measure at the specified time point for each arm."|||10^9 cells/Liter||Standard Error|Mean
1263306|NCT00410280|Secondary|Total Blood Eosinophil Counts at Baseline|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on day 13 and 34).|Baseline|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||10^9 cells/Liter||Standard Deviation|Mean
1263307|NCT00410280|Secondary|Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34). Results are reported for total IgE count.|Baseline, Day 13, 34, 56, 112, 168|"ITT population. Here, n signifies participants evaluated for this measure at the specified time point for each arm. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed."|||kU/L||Standard Error|Mean
1288257|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12||Month 12||||L||Standard Error|Mean
1263308|NCT00410280|Secondary|Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge within a given challenge triad (planned on day 13 and 34). The challenge triad included pre-allergen methacholine inhalation challenge, allergen inhalation challenge, and post-allergen methacholine inhalation challenge. Results are reported for total IgE count.|Baseline|ITT population included all randomized participants who received at least 1 dose administration of the test article. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.|||kilo unit/liter (kU/L)||Standard Deviation|Mean
1263309|NCT00410280|Secondary|Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35|The collected sputum was planned to be analyzed for epithelial cells, eosinophils, lymphocytes, neutrophils, metachromatic cells, or macrophages counts. Sputum induction was to be performed after each methacholine challenge and at 7 hours after each allergen inhalation challenge.|Baseline, Day 14, 35|Data was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.||||||
1263310|NCT00410280|Secondary|Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge|Methacholine inhalation test was performed to determine airway hyper-reactivity using provocative concentration 20 (PC20). PC20 was the lowest concentration of methacholine at which participant had 20% decrease from baseline in FEV1. Pre-allergen challenge methacholine inhalation test was performed 1 day prior to the allergen challenge and post-allergen challenge methacholine inhalation test was performed 1 day after to the allergen challenge (that is, pre- and post-allergen methacholine inhalation test was conducted on Day -15 and -13 for Screening allergen challenge, Day 13 and 15 for Day 14 allergen challenge and Day 34 and 36 for Day 35 allergen challenge, respectively). For each methacholine inhalation test, baseline FEV1 was defined as the lowest value among the triplicate readings taken after administration of the diluent (saline administration). Difference between post-allergen challenge and pre-allergen challenge was expressed as log2 (post-allergen PC20 – pre-allergen PC20).|Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||Log2 milligram/milliliter (log2 mg/mL)||Standard Deviation|Mean
1263311|NCT00410280|Secondary|Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR)|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 0 to 3 hours at each visit was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop*hour||Standard Deviation|Mean
1263312|NCT00410280|Secondary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 0 to 3 hours was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop||Standard Deviation|Mean
1263313|NCT00410280|Secondary|Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR)|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of >=15% at 3 to 7 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 3 to 7 hours was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||Percent drop*hour||Standard Deviation|Mean
1263314|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 35 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop||Standard Deviation|Mean
1263323|NCT00410202|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1264527|NCT00401973|Primary|Change From Baseline to Endpoint in Weight||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement.|||kilograms||Standard Error|Least Squares Mean
1263315|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 14 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop||Standard Deviation|Mean
1263316|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours at Screening was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop||Standard Deviation|Mean
1263317|NCT00410202|Secondary|Number of Participants With Laboratory Abnormalities: Serum Chemistry|ULN=upper limit of normal (Normal ranges are Central lab data and vary according to the site). ALT:>1.25*ULN, AST:>1.25*ULN, ALP:>1.25*ULN, Total Bilirubin:>1.1*ULN, Serum Lipase:>1.10*ULN, Creatinine:>1.1*ULN, Blood Urea Nitrogen:1.25*ULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L; ALT flare: on treatment (OT), >2*Baseline and >10*ULN; off treatment (OF), 2*end of dosing value and >10*ULN|On treatment : Day 1 through Week 100 + 5 days; Offtreatment = End of OT period through 24 weeks|All treated participants. n = number of participants in the OF period.|||participants|||Number
1263318|NCT00410202|Secondary|Number of Participants With Laboratory Abnormalities: Hematology|Criteria for hematology abnormalities were: Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.|From start of study through Week 100 + 5 days|All treated participants.|||participants|||Number
1263319|NCT00410202|Secondary|Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade 1 = mild, Grade 2= moderate, Grade 3 = severe, Grade 4 = life threatening/disabling, Grade 5 = death.|From start of study therapy through Week 100 + 5 days|All treated participants.|||participants|||Number
1263320|NCT00410202|Secondary|Cumulative Probability of Emergent Genotypic Resistance at Year 2|"Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)."|Year 2|Treated participants who were tested for resistance were analyzed, ie. They met the following selection criteria: 1) participants with HBV DNA ≥ 50 IU/mL at Week 96 or at the last on-treatment visit and 2) who developed VBT. n=participants|||percentage of participants|||Number
1263321|NCT00410202|Secondary|Cumulative Probability of Emergent Genotypic Resistance at Year 1|"yr=year. Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)."|Year 1|Treated participants who were tested for resistance, ie. met the following selection criteria. 1) participants with HBV DNA ≥ 50 IU/mL at Week 48 or at the last on-treatment visit and 2) who developed VBT . n=participants|||percentage of participants|||Number
1263322|NCT00410202|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 96|Participants who received at least 1 dose of study therapy were analyzed. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263551|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||millimole/Liter||Standard Deviation|Mean
1263326|NCT00410202|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 96|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263327|NCT00410202|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 48|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263328|NCT00410202|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 96|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263329|NCT00410202|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 48|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263330|NCT00410202|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.|Baseline, Week 96|Participants who received at least 1 dose of study therapy and had ALT > 1 x ULN at baseline (day 1) were analyzed. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263331|NCT00410202|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 or 48 U/L.|Week 48|Participants who received at least 1 dose of study therapy and had ALT > 1 x ULN at baseline (day 1). Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263332|NCT00410202|Secondary|Change in Mean log10 From Baseline in HBV DNA at Week 96|HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load.|Baseline, Week 96|Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values were analyzed. n= participants with baseline and Week 96 values.|||participants||Standard Error|Mean
1263333|NCT00410202|Secondary|Change in Mean log10 From Baseline in HBV DNA at Week 48|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction.|Baseline, Week 48|Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values. n=participants with baseline and Week 48 values.|||log10 (IU/mL||Standard Error|Mean
1263334|NCT00410202|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay.|Week 96|Participants who received at least 1 dose of study therapy were analyzed.|||percentage of participants|||Number
1263335|NCT00410202|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay.|Week 48|Participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
1263336|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263337|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263338|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||Percentage of participants|||Number
1263339|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1288258|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6||Month 6||||L||Standard Deviation|Mean
1263340|NCT00410202|Secondary|Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||Percentage of participants|||Number
1263341|NCT00410202|Primary|Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
1263342|NCT00410189|Primary|8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease)|The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|Baseline to 8 Weeks||||percentage of participants|||Number
1263343|NCT00410189|Secondary|8 Week Progression-Free Survival|Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.|Every 8 weeks till disease progression.||||months||Full Range|Median
1263344|NCT00410163|Secondary|Number of Participants With Progression or Death|Disease progression is characterized by at least one of the following, per the Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia: a >=50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations 2 weeks apart (at least one node must be >=2 centimeters); or the appearance of new palpable lymph nodes; or a >=50% increase in liver and/or spleen size (measurement below the costal margin); or the appearance of palpable hepatomegaly or splenomegaly not previously present; or a >=50% increase in the numbers of circulating lymphocytes to at least 5.0 * 10^9/Liter; or transformation to a more aggressive histology (e.g., Richter’s syndrome or prolymphocytic leukemia with >55% prolymphocytes). For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years|FAS|||Participants|||Number
1263345|NCT00410163|Secondary|Vss After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||liters||Geometric Coefficient of Variation|Geometric Mean
1263346|NCT00410163|Secondary|CL After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1263347|NCT00410163|Secondary|t1/2 After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
1263348|NCT00410163|Secondary|AUC(0-inf) and AUC(0-672) After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-672) is AUC from start of infusion to 672 hours after start of infusion; AUC(0-inf) is AUC from start of infusion extrapolated to infinity.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milligrams * hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
1263349|NCT00410163|Secondary|Ctrough and Cmax at the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). No drug is present before the first infusion; therefore, there are no Ctrough results for the first infusion.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
1263350|NCT00410163|Secondary|Number of Participants Classified as Responders Having CR Who Tested Negative for Minimal Residual Disease (MRD)|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells (CD5+CD19+) to determine if there was any MRD.|From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to course 6 or Week 32)|FAS. Only participants with CR at Visit 34 were analyzed.|||participants|||Number
1264128|NCT00405509|Secondary|Severity of Symptom Scores - COUGH|Cough symptoms were rated by the participant each day for 6 days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on day 30||||units on a scale||Standard Deviation|Mean
1263351|NCT00410163|Primary|Number of Participants (Par.) Who Were Classified as Responders and Non-responders|Par. were evaluated by an IRC in accordance with NCI-WG 1996 guideline. Responders: CR, Nodular Partial Remission (nPR, same as CR, but persistent bone marrow nodules), and Partial Remission (PR, >=50% decrease in lymphocytes from pretreatment baseline (BL) value, >=50% reduction in lymphadenopathy, >=50% reduction of liver/spleen and neutrophils >= 1.5*10^9/L or platelets >100*10^9/L or hemoglobin >11 g/dL (or 50% improvement over BL for neutrophils, platelets, hemoglobin); non-responders: Stable Disease (SD, did not achieve CR/PR, and no PD), Progressive Disease (PD), or Not Evaluable (NE).|From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|FAS|||participants|||Number
1263352|NCT00410163|Secondary|Percent Change From Screening (Visit 1) in Complement (CH50) Levels at Visit 9 (Week 4)|Blood samples were drawn from participants at Visits 1 and 9 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 9 minus value at Visit 1 divided by value at Visit 1) * 100.|Visit 1 (Week -2) and Visit 9 (Week 4)|FAS. Data were provided for the number of participants attending Visit 9. Participants withdrawn during the study were not analyzed.|||Percent change in complement levels||Full Range|Median
1263353|NCT00410163|Secondary|Number of Participants Who Reported Myelosuppression (Anemia, Leukopenia, Neutropenia, and Thrombocytopenia)|Myelosuppression is one of the expected AEs for FC treatment and is defined as the decrease in the ability of the bone marrow to produce blood cells. The number of participants with myelosuppression was assessed from laboratory measurements with Grades 3(severe)-4 (life-threatening/disabling) (1, mild; 2, moderate; 5, death) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The CTCAE is issued by the National Cancer Institute (NCI) and is the standard classification used for the severity grading scale for AEs in cancer therapy clinical studies.|From first treatment (Visit 2) up to Visit 43 (Month 60)|FAS|||participants|||Number
1263354|NCT00410163|Secondary|Number of Participants With Positive Human Anti-human Anti Bodies (HAHA) at Visits 1, 21, 35, and 39|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 21, 35, and 39 for analysis of HAHA. Analysis of HAHA was done in batches.|Visits 1 (Screening, Visit -2), 21 (Week 12), 35 (Month 6), and 39 (Month 18)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||participants|||Number
1263355|NCT00410163|Secondary|Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 43 (Month 60)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.|From first treatment (Visit 2) up to Visit 43 (Month 60)|FAS|||participants|||Number
1263356|NCT00410163|Secondary|Median Percent Change in CD5+CD19+ and CD5+CD20+ Cells in Peripheral Blood From Onset of Course 3 Throughout Follow-up (FU) Compared to Screening|Malignant B cells (CD5+CD19+ and CD5+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Screening (Visit 1, Week -2) = (value at indicated visits minus value at Visit 1 divided by value at Visit 1) * 100. Visits 33 and 34 are measured in the number of months from the start of the last infusion. The start of the last infusion could have occurred up to Week 20.|Baseline Visit 2 (Week [Wk] 0); Visits 15 (Wk 8), 21 (Wk 12), 25 (Wk 16), 29 (Wk 20), 33 (Month [M] 1 after start of last infusion [LI]), 34 (M 3 after start of LI)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||percent change in cells||Full Range|Median
1263357|NCT00410163|Secondary|Median Percent Change in Tumor Size From Baseline (Visit 2, Wk 0) at Visits 9, 21, 25, 29, 33, 34, 35, and 37|Tumor size was measured by physical examination of palpable abnormal lymph nodes. Percent change from Baseline (Visit 2, Week 0) = (value at indicated visits minus value at Visit 2 divided by value at Visit 2) * 100. Visits 33, 34, 35, 36, and 37 are measured in the number of months from the start of the last infusion. The start of the last infusion could have occurred up to Week 20.|Baseline Visit 2 (Week [Wk] 0); Visits 9 (Wk 4), 21 (Wk 12), 25 (Wk 16), 29 (Wk 20), 33 (Month [M] 1 after start of last infusion [LI]), 34 (M 3 after start of LI), 35 (M 6 after start of LI), 36 (M 9 after start of LI), and 37 (M 12 after start of L|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||percent change in tumor size||Full Range|Median
1263358|NCT00410163|Secondary|Time to Next Anti-chronic Lymphocytic Leukemia (CLL) Therapy or Death|Time to next anti-CLL (anti-lymphoma) therapy was defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab or death. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.|From time of randomization to first administration of next anti-CLL therapy other than ofatumumab or death, assessed over 5 years|FAS|||months||95% Confidence Interval|Median
1263359|NCT00410163|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years|FAS|||months||95% Confidence Interval|Median
1263360|NCT00410163|Secondary|Duration of Response|The duration of response was defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed.|From time of initial response to disease progression or death, whichever came first, assessed over 2 years|FAS. Only those participants classified as responders were analyzed.|||months||95% Confidence Interval|Median
1263434|NCT00409825|Primary|Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.|"Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy.~We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days."|Second and third trimesters of pregnancy||||ng/ML/day||Standard Deviation|Mean
1263435|NCT00409786|Secondary|Physical Activity||1 year|||||||
1263361|NCT00410163|Primary|Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion|"Par. were evaluated for response by an Independent Endpoint Review Committee (IRC) in accordance with the National Cancer Institute-sponsored Working Group (NCI-WG) 1996 guideline. Par. with Complete Remission (CR) were classified as complete responders. As per NCI-WG, CR requires all of the following criteria for a period of >=2 months: absence of lymphadenopathy (all lymph nodes <1.0 centimeters), no hepatomegaly/splenomegaly, absence of constitutional symptoms, lymphocytes <=4.0*10^9/liter (L), neutrophil leukocytes >=1.5*10^9/L, platelets >100*10^9/L, and hemoglobin >11 grams/deciliter."|Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment|||participants|||Number
1263362|NCT00410150|Primary|Length of Stay|Time to discharge eligibility (hours)|Hospital discharge||||hours||Standard Error|Mean
1263363|NCT00410124|Secondary|Pharmacokinetics of RAD001: Normalized to Body Surface Area (CL/F)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||L/hour/m^2||Standard Deviation|Mean
1263364|NCT00410124|Secondary|Pharmacokinetics of RAD001: Apparent Systemic Clearance From Blood Following Extravascular Administration (CL/F)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.Apparent oral clearance of RAD001 (CL/F) was calculated using AUC in a dosing interval of 24 hours (AUC0-24hours) value on Day 15 as: CL/F = dose/ AUC0-τ|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||L/hour||Standard Deviation|Mean
1263365|NCT00410124|Secondary|Pharmacokinetics of RAD001: Time of the Last Quantifiable Concentration in a Dosing Interval - (Tlast)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||hour||Full Range|Median
1263366|NCT00410124|Secondary|Pharmacokinetics of RAD001: Area Under Curve (AUC) in a Dosing Interval From Time-zero to Time of the Last Quantifiable Concentration. (AUC 0-tlast)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||ng.h/mL||Standard Deviation|Mean
1263367|NCT00410124|Secondary|Pharmacokinetics of RAD001: Time at Which C-Max Occurs (t-Max)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose of From Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||h||Full Range|Median
1263368|NCT00410124|Secondary|Pharmacokinetics of RAD001:Peak Concentration in a Dosing Interval (C-max); Pre-dose Concentration at 24-h Time Point in Dosing Interval (C-min) and Average Concentration in a Dosing Interval =(C-avg)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol. C-avg= Area under curve (AUC) in a dosing interval from time-zero to time of the last quantifiable concentration (AUC0-tlast)/ time of the last quantifiable concentration in a dosing interval (tlast)|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day1, Cycle 1 Day 15 and at pre-dose from Cycle 2(day1) and all subsequent treatment cycles up until data cut-off 28 Feb 2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||ng/mL||Standard Deviation|Mean
1263369|NCT00410124|Secondary|Time to Definitive Deterioration of the Physical Functioning Scale (PF)Score of the EORTC QLQ-C30 Questionnaire by at Least 10 Percent Using Kaplan_Meier Method, by Treatment.|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Physical Functioning (PF) sub-scale, consisting of 5 questions each scored from 1 (not at all) to 4 (very much), and with possible values ranging from 5 to 20. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||months||95% Confidence Interval|Median
1263436|NCT00409786|Secondary|Health Related Quality of Life||1 year|||||||
1263437|NCT00409786|Secondary|Fat Consumption||1 year|||||||
1263438|NCT00409786|Secondary|A1C (if Applicable)||1 year|||||||
1263439|NCT00409786|Secondary|Lipid||1 year|||||||
1263370|NCT00410124|Secondary|Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.|"The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. 0= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen."|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||months||95% Confidence Interval|Median
1263371|NCT00410124|Secondary|Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||months||95% Confidence Interval|Median
1263372|NCT00410124|Secondary|Duration of Response in Patients Who Receive RAD001 Plus BSC Versus Placebo Plus BSC|Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR). The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as the first documented progression or death. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||months||95% Confidence Interval|Median
1263373|NCT00410124|Secondary|Best Overall Response Rate in Patients Who Receive RAD001 Plus BSC Versus Matching Placebo Plus BSC|The Best Overall Response rate (BOR) is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date|Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.|||Percentage of Participants||95% Confidence Interval|Number
1263374|NCT00410124|Secondary|Overall Survival (OS) Assessed by the Monthly Overall Survival Assessments|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group|Assessed every month up to 2 years after the last patient was randomized into the study from the date of randomization to the time of death. (Data cutoff was 15Nov2009)|Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1263375|NCT00410124|Primary|Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC|Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1263376|NCT00410072|Secondary|Number of Participants With Virologic Breakthrough at Week 96|ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir|Week 96|Participants with confirmed >= 1 log10 increase in HBV DNA from moving nadir|||Participants|||Number
1263377|NCT00410072|Secondary|Number of Participants With Virologic Breakthrough at Week 48|ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir|Week 48|Participants with confirmed >=1 log10 increase in HBV DNA from the on-treatment nadir|||Participants|||Number
1263378|NCT00410072|Secondary|Number of Participants With HBV Resistance at Week 96|ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.|Week 96|Participants who received study drug and with HBV DNA levels >=50 IU/mL.|||Participants|||Number
1263440|NCT00409786|Secondary|Blood Pressure||1 year|||||||
1263379|NCT00410072|Secondary|Number of Participants With HBV Resistance Through Week 48|ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.|Week 48|All participants who received study drug and with HBV DNA levels >=50 IU/mL|||Participants|||Number
1263380|NCT00410072|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From enrollment through Week 100 + 24-week follow-up|All treated participants.|||Participants|||Number
1263381|NCT00410072|Secondary|Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96|Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.|At Weeks 48 and 96|All treated participants.|||Percentage of participants|||Number
1263382|NCT00410072|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||Percentage of participants|||Number
1263383|NCT00410072|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96|HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||Percent of participants|||Number
1263384|NCT00410072|Secondary|Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96|HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication.|At Weeks 48 and 96|Treated HBeAg-positive participants. A participant missing the efficacy assessments for a visit was considered a failure and was counted as evaluable.|||Percentage of participants|||Number
1263385|NCT00410072|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96|HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||Percentage of participants|||Number
1263386|NCT00410072|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96|ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and counted as evaluable.|||Percentage of participants|||Number
1263387|NCT00410072|Secondary|Mean Log 10 HBV DNA at Weeks 48 and 96|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load.|Baseline, Weeks 48 and 96|Evaluable participants at given time point. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||log10 copies/mL||Standard Error|Mean
1263388|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96|LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.|||Percentage of participants|||Number
1263389|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96|LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.|||Percentage of participants|||Number
1263390|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status|HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||Percentage of participants|||Number
1263391|NCT00410072|Primary|Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96|HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Week 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.|||Percentage of participants|||Number
1263392|NCT00410059|Primary|8 Week Progression-Free Survival Rate (i.e. Disease Control Rate)|Progression-free survival (i.e. disease control rate) defined as percentage of participants without progression at 8 weeks, evaluation after the second cycle of therapy (i.e., 8 weeks), with confirmation of efficacy 2 cycles after its initial assessment. A “success” or “disease control” to treatment is defined as a participant being progression free at 8 weeks after randomization.|Radiographic evaluation after cycle 2 (8 weeks of therapy)|One participant was not evaluable for outcome.|||Participants|||Count of Participants
1263393|NCT00410046|Secondary|Change From Baseline Haywood Quality of Life Score From Baseline to Week 38|Haywood quality of life instrument was utilized in the United Kingdom as the ASQoL measure. The ASQoL is an AS-specific measure of QoL, scores range from 0 (good QoL) to 80 (poor QoL). ASQoL is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patient's 0881A3-402 baseline score was used in the analysis. Change=baseline-week 38.|Baseline and 38 weeks|All patients from United Kingdom sites who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug had at least 1 post-baseline assessment and completed 38 weeks.|||units on scale||Standard Deviation|Mean
1263394|NCT00410046|Secondary|Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the patient as a ‘Yes’ (scored as 1) or ‘No’ (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). The 0881A3-402 baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug, had at least 1 post-baseline assessment, and completed 38 weeks.|||units on scale||Standard Deviation|Mean
1263395|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The fatigue-specific score is presented here. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
1263396|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
1263397|NCT00410046|Primary|Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment|Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).|96 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||patients|||Number
1263398|NCT00410046|Primary|Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).|96 weeks|All patients who took ETN and completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||patients|||Number
1263399|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
1263400|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38|BASFI is a validated self assessment tool that determines the degree of functional limitation in Ankylosing Spodylitis (AS) patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions, with a maximum score of 100 mm. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
1263401|NCT00410046|Secondary|Change in Total Back Pain Score From Baseline to Week 38|Total Back Pain was measured on a 0 to 100 mm VAS, with 0 mm indicating no pain. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
1263402|NCT00410046|Secondary|Change in Patient Global Assessment of Disease Activity From Baseline to Week 38|Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment|||units on scale||Standard Deviation|Mean
1263403|NCT00410046|Secondary|Number of Sick Days Per Patient During the 48 Weeks of Treatment|Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days. The mean number of days is based on those patients who had sick leave during the treatment period.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Sick days per patient||Full Range|Mean
1263404|NCT00410046|Secondary|Number of Patients With Sick Leave During 48 Weeks Treatment|The impact of treatment on work productivity was assessed by sick leave. Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||patients|||Number
1263405|NCT00410046|Secondary|Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking all patients whether or not they had used the healthcare resource during the 48 weeks of treatment, and if so, how many times the resource was used. The mean number of times is based on those patients who responded to the questionnaire stating they had utilized healthcare resources (see outcome measure 3).|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into study 0881A3-405, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||# of times utilized per patient||Full Range|Mean
1263406|NCT00410046|Secondary|Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks of treatment.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||patients|||Number
1263407|NCT00409838|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate||Days 169 to 1569|Participants who completed the Short-term Period. n=Number of evaluable participants.|||mm/h||Standard Error|Mean
1263408|NCT00409838|Secondary|Change From Baseline in Levels of C-reactive Protein (CRP)||Days 169 to 1569|Participants who completed the Short-term Period. n=Number of evaluable participants.|||mg/dL||Standard Error|Mean
1263409|NCT00409838|Secondary|Percentage of Participants With Low Disease Activity Score (LDAS) or Who Are in Remission|LDAS is defined as a Disease Activity Score C-reactive protein (DAS28-CRP) level <=3.2. Remission is defined as a DAS28-CRP level <2.6.|At Days 169, 337, 729, 1149, and 1485|All participants who finished the Short-term period. n=Number of evaluable participants|||Percentage of participants||95% Confidence Interval|Number
1263410|NCT00409838|Secondary|Changes From Baseline in the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) Scores|The SDAI is the sum of 5 parameters: Tender joint (TJC) and swollen joint(SJC)counts, based on a 28-joint assessment; patient global (PtGA)and physician global assessments (PGA), assessed on 0-10 cm visual analog scale (VAS), on which higher scores=greater affection due to disease activity DA); and C-reactive protein level. SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low DA, >11 to 26=moderate DA, and >26=high DA. SJC is assessed at each visit, with no swelling=0, swelling=1. TJC is assessed through identification of joints painful under pressure or to passive motion at each visit, with no tenderness=0, tenderness=1. Higher score=greater affection due to DA. CDAI is sum of 4 parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score=0-76. CDAI <=2.8 indicates disease remission, >2.8 to 10=low DA, >10 to 22=moderate DA, and >22=high DA.|At Days 169 and 1569|All participants who received study drug and who were evaluable|||Units on a scale||95% Confidence Interval|Mean
1263411|NCT00409838|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and With EULAR-defined Remission|EULAR defines LDAS as a disease activity score as measured by c-reactive protein (DAS28-CRP) ≤3.2 and remission as DAS28-CRP <2.6|At Days 169 and 1485|All participants who received study drug and who were evaluable|||Percentage of participants|||Number
1263441|NCT00409786|Primary|Change in Weight||Baseline and 1 year|Of the original 50 participants, 12 month data was collected for 45 (90%) of them. Analysis was conducted on those participants with 12 month data.|||kg||95% Confidence Interval|Mean
1264129|NCT00405509|Secondary|Nasal Secretion Weights|Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight|each day for 5 days||||grams||Standard Deviation|Mean
1263412|NCT00409838|Secondary|Changes From Baseline in Short-Form 36 (SF-36) Physical and Mental Health Summaries|The SF-36 is a 36-item questionnaire used to measure Quality of Life over 8 physically and emotionally based areas: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Answers to each question correspond to a precoded numeric value. An aggregate percentage score is reached for each of the 8 sections and is based on answers to questions. The mean average is worked out for each section. Scores range from 0% (lowest level of functioning) to 100% (highest level of functioning, with higher score indicated increasing levels of functioning.|At Day 1485|All participants who received study drug and who were evaluable|||Units on a scale||Standard Error|Mean
1263413|NCT00409838|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|Day 1485|All participants who received study drug and who were evaluable|||Units on a scale||Standard Error|Mean
1263414|NCT00409838|Secondary|Percentage of Participants With Physical Function Response as Assessed Using the Health Assessment Questionnaire Disability Index (HAQ-DI)|Improvement is measured by an improved response of at least 0.3 units from baseline on the HAQ-DI score. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|At Day 1485|All participants who received study drug and who were evaluable|||Percentage of participants|||Number
1263415|NCT00409838|Secondary|Percentage of Participants Achieving ACR20, ACR50, and ACR70 Over Time|The ACR 20, ACR50, and ACR70 are based on 20%, 50% and 70% improvement, respectively, (compared with baseline values) in tender and swollen joint counts and on 20%, 50% and 70%, respectively, improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.|Days 15 through 1569|All participants who completed the ST period and received at least 1 infusion of abatacept during the LTE period. n=evaluable participants at that timepoint for that measure.|||Percentage of participants||95% Confidence Interval|Number
1263416|NCT00409838|Secondary|LTE Period: Overall Number of Participants With Positive Results of Immunogenicity Samples|Positive antibody titers were identified by validated enzyme-linked immunosorbent assay results. On-treatment samples were obtained during the LTE period, and posttreatment samples were following the last infusion of study medication.|Days 169, at 6-month intervals on-treatment, and at Days 28, 56, and 85 after the last infusion of study medication in the LTE period|All participants who during the LTE period, received at least 1 infusion of abatacept and had at least 1 immunogenicity sample collected.|||Participants|||Number
1263417|NCT00409838|Primary|Long-term Extension (LTE) (Open-Label) Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuatons Due to SAEs, Adverse Events (AEs), Related AEs, and Discontinuations Due to AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Day 169 to up to 56 days post the last dose (Day 1485) in the LTE period|All participants who completed the short-term period and received at least 1 infusion of abatacept during the LTE period|||Participants|||Number
1263418|NCT00409838|Secondary|Change From Baseline in Surrogate Marker Rheumatoid Factor (RF) at Day 169|Mean change in RF. A surrogate marker is an indirect measurement of effectiveness. Mean change from Baseline = postbaseline - baseline value.|Baseline, Day 169|All Randomized and Treated Participants. The summary was based on the last observation carried forward (LOCF) procedure. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.|||IU/mL||Standard Error|Mean
1263419|NCT00409838|Secondary|Change From Baseline in Surrogate Marker Erythrocyte Sedimentation Rate (ESR) at Day 169|Mean change in surrogate marker mean ESR. A surrogate marker is an indirect measurement of effectiveness. Change from Baseline = postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.|||mm/h||Standard Error|Mean
1263420|NCT00409838|Secondary|Immunogenicity of Abatacept- Number of Participants With Reactivity Toward CTLA4-IG and CTLA4-T at Day 169|Immunogenicity was determined by measuring adult subject sera for reactivity against the whole Abatacept molecule (CTLA4Ig) and CTLA4-T (CTLA4 without the Ig regions).|Day 169|All participants who received study drug (abatacept)|||participants|||Number
1263421|NCT00409838|Secondary|Summary Statistics of Minimum Observed Serum Concentration (Cmin) for Abatacept|Minimum concentration (Cmin) of Abatacept 500 mg and 750 mg at given time points|At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85|Participants with measurement at timepoint|||μg/mL||Standard Deviation|Mean
1263422|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Volume at Steady State (VSS)|The volume of distribution of drug at steady state (VSS). Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.|At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113|Participants with measurement at stated dose level|||L/kg||Standard Deviation|Mean
1263423|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Total Body Clearance (CLT)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Clearance is a pharmacokinetic parameter that describes how quickly drugs are eliminated, metabolized or distributed throughout the body.|Day 29, every 28 days until Day 141|Participants with measurement at stated dose level|||mL/h/kg||Standard Deviation|Mean
1263424|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters - Area Under the Curve (AUC)|Area Under the Plasma Concentration-Time Curve (AUC), a measure of drug absorption, in a dosing interval of 28 days from Day 85 to Day 113. Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.|At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113|Participants with measurement at stated dose level|||μg.h/mL||Standard Deviation|Mean
1263425|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters - Maximum Concentration (Cmax)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Maximum Concentration (Cmax)= the maximum plasma concentration of the drug.|At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113|Participants with measurement at stated dose level|||μg/mL||Standard Deviation|Mean
1263426|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Time to Maximum Concentration (Tmax) and Half-Life of Elimination (T-Half)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Tmax = the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. T-Half = the biological half-life or elimination half life of a substance is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity.|At the end of infusion and 2 to 4 hours after the start of infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113|Participants with measurement at stated dose level|||Hours||Standard Deviation|Mean
1263427|NCT00409838|Secondary|Percentage of Participants Experiencing Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), Related SAEs and AEs, and Discontinuations Due to SAEs and AEs During the Double-Blind Period|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout double-blind study period (up to Day 169); table includes data up to 56 days past double-blind period or start of the open-label period, whichever occurred first.|All randomized participants who received study drug.|||Percentage of participants|||Number
1263428|NCT00409838|Secondary|Change From Baseline to Day 169 in Analysis of Short-Form 36 (SF-36) Health Survey Questionnaire Domains|Adjusted mean change from baseline. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life and comprised of 8 domains( including 4 physical and 4 mental subscales) used to derive the physical and mental component summary scores. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Change from baseline=postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug and were evaluable.|||Units on a scale||Standard Error|Mean
1263429|NCT00409838|Secondary|Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|Adjusted mean change from baseline. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug|||Units on a scale||Standard Error|Mean
1263430|NCT00409838|Secondary|Change From Baseline in Disease Activity Scores (DAS) Based on C-reactive Protein (DAS 28 [CRP]) Levels or Erythrocyte Sedimentation Rate (DAS 28[ESR])|Adjusted mean change from baseline. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). CRP or ESR give estimations of DAS28 values on a group level. Change from Baseline=Postbaseline - Baseline value.|From Baseline to Days 169 and 1485|All randomized participants who received study drug and who were evaluable.|||Units on a scale||Standard Error|Mean
1263431|NCT00409838|Secondary|Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in American College of Rheumatology (ACR) Core Components|The ACR defines improvement in core components as 20%, 50%, or 70% improvement in tender and swollen joint counts and 3 of the remaining core components: patient global assessment of disease activity, physician global assessment of disease activity, patient assessment of pain, patient self-assessed disability (Health Assessment Questionnaire Disability Index [HAQ-DI]), and levels of 1 acute phase reactant (C-reactive protein levels or erythrocyte sedimentation rate.) The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning; scale=0 (no disability) to 3 (completely disabled); total possible score=24. The higher the score, the greater the disability.|From Baseline to Day 169|All randomized participants who received study drug and who were evaluable.|||Percentage of participants|||Number
1263432|NCT00409838|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169|The ACR defines ACR 50 and ACR70 response as a 50% or 70% improvement (compared with baseline values) in tender and swollen joint counts and 50% or 70% improvement in 3 of the remaining 5 core set measures (patient global assessment of pain, patient global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and 1 acute phase reactant value (C-reactive protein).|At Day 169|All randomized participants who received study drug.|||Percentage of participants|||Number
1263433|NCT00409838|Primary|Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20)|The ACR 20 is based on 20% improvement (compared with baseline values) in tender and swollen joint counts and on 20% improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.|At Day 169|All randomized participants who received study drug.|||percentage of participants|||Number
1264130|NCT00405509|Primary|Local Leukotriene Levels|nasal secretions were collected once a day for the first six days of the respiratory infection and on day 30 then measured for leukotriene levels|once a day for 6 days and on day 30||||pg/ml||Standard Deviation|Mean
1263442|NCT00409773|Secondary|Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Median
1263443|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263444|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263445|NCT00409773|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263446|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6||Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263447|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263448|NCT00409773|Secondary|Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263449|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263450|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263451|NCT00409773|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263452|NCT00409773|Secondary|Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263453|NCT00409773|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263454|NCT00409773|Secondary|Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Median
1263455|NCT00409773|Secondary|Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1264155|NCT00405067|Secondary|Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC)||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1263456|NCT00409773|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1263457|NCT00409747|Secondary|Clinical Global Impressions Scale-Severity (CGI). (Connors & Barkley, 1985)|This instrument has two scales – Severity (CGI-S). The CGI-S is a seven point scale with a minimum score of 1 and a maximum score as 7 as follows: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline and 6 months|All children completing 6 months of drug and participating in final evaluation|||mean scores on global impression scale||Standard Deviation|Mean
1263458|NCT00409747|Primary|z Score|"The Mann–Whitney U-test was used to compare pre-/post-treatment differences in analyte concentrations in serum, plasma and CSF. The Mann-Whitney U test generates a z-score test statistic with an associated p value. A negative z-statistic reflects a decrease in analyte level from pre- to post-treatment. Statistical significance level was set at 0.05. There is one test statistic (z-score) per analyte, reflecting the pre-post comparison across all subjects.~Pre and post treatment measurements of csf analytes: TNF alpha, Il-6, CCL-2(MCP-1), CCL3 (MIP-1alpha), CCL5(RANTES), CXCL(IL-8), BDNF, CD40L, GDNF, HGF, Leptin"|Pre and post treatment with minocyline at 6 months for 10 subjects|10 subjects completed six months of minocycline and have pre-/post-minocycline CSF samples for analysis.|||Z-score|||Number
1263459|NCT00409708|Primary|The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12)|The number of micronuclei per 1000 binucleated cells was measured at Baseline ( n=34 , n=29 ) and at the end of treatment, Week 12 (n =34, n= 29), in blood cultured for 48 hours using a standard protocol.|baseline and at end of treatment (Week 12)||||number of micronuclei per 1000 binucleat||Standard Deviation|Mean
1263460|NCT00409708|Secondary|Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S)|The Clinical Global Impression scale (CGI-S) is a clinician-rated instrument designed to assess the severity of illness. The CGI-S rating indicates illness severity at each time-point on a scale as follows: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. CGI-S assessments are relative to the patient’s status at the Baseline visit.|From baseline to the end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.|||Units on a rating scale||Standard Deviation|Mean
1263461|NCT00409708|Secondary|Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I)|The Clinical Global Impression scale (CGI-I) is a clinician-rated instrument designed to assess the overall change of illness relative to baseline. The CGI-I consists of 7 ratings as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I assessments are relative to the patient’s status at the Baseline visit.|From baseline to the end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.|||Units on a rating scale||Standard Deviation|Mean
1263462|NCT00409708|Secondary|Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P)|"Parents completed the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) consisting of the ADHD Index (12 items) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)( 18 items). Parents rated their child's behavior of the previous week from a list of common problems. When asked How much of a problem has this been in the last week?” parents selected 0 = none, not at all, seldom, or very infrequently; 3 = very much true, or it occurs very often or frequently; or 1 or 2 for ratings in between. A score of 50 is considered normal and more than 70 markedly atypical."|Baseline to end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.|||Units on a rating scale||Standard Deviation|Mean
1263463|NCT00409708|Secondary|Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes|Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics.|End of treatment (Week 12)||||Number|||Number
1263464|NCT00409708|Secondary|Number of Sister Chromatoid Exchanges Per Cell|Blood collected at baseline (n=20, n=14) and at the end of treatment, Week 12, (n= 20, n= 14) was cultured for 48 hours using a standard protocol. Giemsa staining and/or fluorescent in situ hybridization (FISH) chromosome painting was done on the cells in metaphase and the number of chromatoid exchanges per cell was recorded by blinded raters.|baseline and at end of treatment (Week 12)|Per-Protocol-2 population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.|||number of sister chromatoid exchanges||Standard Deviation|Mean
1263465|NCT00409708|Primary|The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12)|The number of chromosomal aberrations per 100 cells excluding gaps at Baseline (n=33, n=32) and at Week 12 (n=33, n=32) was counted in blood samples cultured for 48 hours using a standard protocol. The types of abnormalities included translocations (reciprocal and non-reciprocal), insertions, dicentrics, fragments, inversions, chromatid exchanges (quadriradials and triradials), breaks, and other unusual observations, eg, aneuploidy, tetraploidy or endoreduplication.|baseline and at end of treatment (Week 12)|Per-Protocol-1 (PP1) population: The PP1 population consisted of all patients who were randomized and provided cytogenetic data for at least one of the primary endpoints at baseline and at the Week 12 evaluation.|||number of abnormalities||Standard Deviation|Mean
1263475|NCT00409617|Secondary|Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment|Percent Work Time Missed (Absenteeism) due to CD is one component of the Work Productivity and Activity Impairment (WPAI) Questionnaire. Score of 0% = no impairment. A decrease in the mean indicates improvement.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 369 participants had data available for calculating change in Percent Work Time Missed. Missing values were imputed using LOCF.|||Percent of work time missed||Standard Deviation|Mean
1263466|NCT00409682|Secondary|Change From Baseline IMPACT III Scores at Week 52 (Observed Case)|The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.|Baseline and Week 52|Intent-to-treat (ITT) population for observed case (OC).|||Scores on a scale||Standard Deviation|Mean
1263467|NCT00409682|Secondary|Change From Baseline IMPACT III Scores at Week 26 (Observed Case)|The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.|Baseline and Week 26|Intent-to-treat (ITT) population for observed case (OC).|||Scores on a scale||Standard Deviation|Mean
1263468|NCT00409682|Secondary|Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 52|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.|Week 52|Intent-to-treat population using non-responder imputation (NRI) method.|||percent of participants|||Number
1263469|NCT00409682|Secondary|Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 26|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.|Week 26|Intent-to-treat population using non-responder imputation (NRI) method.|||percent of participants|||Number
1263470|NCT00409682|Secondary|Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 52|"Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100 with higher scores indicating more active disease. Clinical remission was defined as PCDAI score of ≤ 10.~The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to treat population."|Week 52|Intent-to-treat population using non-responder imputation method.|||percent of participants|||Number
1263471|NCT00409682|Primary|Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to-treat population.|Week 26|Comparison of adalimumab High-Dose versus Low-Dose with respect to the primary efficacy endpoint in the intent-to-treat analysis set as all randomized subjects who received at least one dose of double-blind study medication.|||percent of participants|||Number
1263472|NCT00409617|Secondary|Mean Change in Activity Impairment Score From Baseline to Week 20|Daily activity is one component of the Work Productivity and Activity Impairment Questionnaire. 0% = no impairment. A decrease in the mean indicates improvement.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used. Data for 902 participants were available for calculating change from Baseline at Week 20 of treatment. Missing values were imputed by LOCF.|||Percent activity impairment||Standard Deviation|Mean
1263473|NCT00409617|Secondary|Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20|6-items that assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID).|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 346 participants for the calculation of mean change in Overall Impairment from Baseline to Week 20. Data were imputed using LOCF.|||Percent total impairment||Standard Deviation|Mean
1263474|NCT00409617|Secondary|Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment|Percent impairment while working is a component of the Work Productivity and Activity Impairment measure. A score of 0% = no impairment. A decrease in mean score indicates lessening of impairment.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 382 participants for the calculation of mean change in Percent Impairment While Working from Baseline to Week 20. Data were imputed using LOCF.|||Percent impairment at work||Standard Deviation|Mean
1263552|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||millimole/Liter||Standard Deviation|Mean
1263476|NCT00409617|Secondary|Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20|10-item assessment of health-related quality of life (QoL) in patients with inflammatory bowel disease. Participant marks an option from 1 to 7 for each item. For some items, 1=None of the time; for other items, 1=All of the time. Value for all items are summed. Total score=10 to 70; a high score=good quality of life (QoL). An increase in score indicates improvement. An absolute change in the SIBDQ score of 9 is considered a minimum clinically important difference (MCID) for a patient.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 907 participants had data available for calculating change in total score of SIBDQ. Missing values were imputed using LOCF.|||Change in total score||Standard Deviation|Mean
1263477|NCT00409617|Secondary|Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.|Number of participants who had EIM at baseline and had resolution of those manifestations at Week 20. EIM were skin lesions, eye lesions, joint complaints, CD-related hepatic disease, thrombosis, and nephrolithiasis. EIMs were determined by physical examination.|Week 20 of treatment|"497 participants who received at least 1 injection of adalimumab (ITT population) had baseline EIM data. Missing data were imputed using non-responder imputation; participants who discontinued the study before Week 20 and participants with missing value at Week 20 were counted as no for resolution."|||Participants|||Number
1263478|NCT00409617|Secondary|Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20|A count of the number of cutaneous fistulas draining was performed during each physical examination. Among participants who had draining fistulas at Baseline, the number of participants who had a reduction in the number of draining fistulas of at least 50% from Baseline to Week 20 of treatment was determined. Fistulas were classified as abdominal or perianal.|Week 20 of treatment|171 participants in the ITT population (participants who received at least 1 injection of adalimumab) had draining fistulas at baseline. Data were available for 148 of the 171 participants at Week 20 of treatment. Missing values were not imputed.|||Participants|||Number
1263479|NCT00409617|Secondary|Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.|5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Participants who had a decrease from Baseline of at least 3 points in HBI total score were considered responders. Missing data were imputed using non-responder imputation (NRI).|Week 20 of treatment|"ITT Population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as no for response."|||Participants|||Number
1263480|NCT00409617|Primary|Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.|5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).|Week 20 of treatment|"Intent-to-treat (ITT) population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as no for remission."|||Participants|||Number
1263481|NCT00409578|Secondary|Percentage of Patients With a Composite Clinical-biochemical Event|A composite clinical-biochemical event was defined as at least one of the following events: cardiovascular death confirmed by adjudication, recurrent MI confirmed by adjudication, hospitalization for CHF confirmed by adjudication, and/or NT-proBNP => 200 pg/mL.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.|||Percentage of patients|||Number
1263482|NCT00409578|Secondary|Percentage of Patients With a Cardiac Event|A cardiac event was defined as at least one of the following events: Cardiovascular death, recurrent myocardial infarction (MI), or hospitalization for congestive heart failure (CHF), all to be confirmed by adjudication.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.|||Percentage of patients|||Number
1263483|NCT00409578|Secondary|Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8|Blood samples for the measurement of BNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.|||pg/mL||95% Confidence Interval|Geometric Mean
1263484|NCT00409578|Primary|Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8|Blood samples for the measurement of NT-proBNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.|||pg/mL||95% Confidence Interval|Geometric Mean
1263485|NCT00409565|Secondary|Disease Control Rate (DCR) ((Clinical Benefit Rate (CBR))|"Disease Control Rate (DCR) (or Clinical Benefit Rate (CBR)), is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to cetuximab and bevacizumab.~DCR = number of patients with (at least) partial response or stable disease / total number of evaluable patients"|At 12 weeks|Patients that were evaluable for 'best response' to treatment.|||percentage of participants|||Number
1263486|NCT00409565|Secondary|Change in Serum Cytokine Concentrations|Ratio of serum cytokines concentration after treatment with cetuximab and bevacizumab to baseline serum cytokines concentration, in picogram/milliliter (pg/ml) for 13 different cytokines. [post-treatment (pg/ml) / baseline (pg/ml)]|Up to 5 years|Patients treated with cetuximab and bevacizumab who provided baseline and post-treatment serum samples.|||post-treatment/baseline pg/ml ratio|||Number
1263487|NCT00409565|Secondary|Overall Survival (OS)|The length of time from the start of study/treatment that diagnosed patients are still alive.|Up to 5 years||||months||95% Confidence Interval|Median
1263488|NCT00409565|Secondary|Progression-free Survival (PFS)|PFS is the length of time during and after treatment that patients are alive with the disease but it does not get worse. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI), Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 5 years|All patients included in study are assessed for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.|||Months||95% Confidence Interval|Median
1263489|NCT00409565|Primary|Objective Response Rate (ORR)|ORR is the percentage of patients whose cancer shrunk or disappeared after study treatment. ORR was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 5 years|Assess all patients included in this study for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.|||percentage of participants||95% Confidence Interval|Number
1263490|NCT00409539|Secondary|To Assess the Safety and Tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d) Following 8-weeks of Treatment in Patients With Over Active Bladder Syndrome|Treatment emergent adverse event summary|8 Weeks||||participants|||Number
1263491|NCT00409539|Primary|Change From Baseline to Week 8 in the Number of Voids/24 Hours||8 Weeks||||voids/24 hrs.||Standard Error|Least Squares Mean
1263492|NCT00409409|Primary|Average Rhinoconjunctivitis Total Symptom Score (ARTSS)|"Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.~Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome."|Pollen period (average of 38.6 days)|The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.|||Units on a scale (range: 0 to 18)||Standard Deviation|Mean
1263493|NCT00409344|Primary|Intensive Care Unit Length of Stay|The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.|1/1/2008||||Days|||Number
1263494|NCT00409344|Secondary|Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed|Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.|1/1/2008||||participants|||Number
1263495|NCT00409344|Secondary|Pharmaco-economics|Did not achieve this outcome due to no enrollment of participants|1/1/2008||||participants|||Number
1263496|NCT00409344|Secondary|Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability|Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome|1/1/2008||||participants|||Number
1263497|NCT00409344|Secondary|Time to Extubation|Did not achieve this outcome due to no enrollment of participants|1/1/2008||||hours|||Number
1263498|NCT00409344|Secondary|Secondary Endpoints Include:Amount of Sedative and Opiates Given|Did not achieve this outcome due to no enrollment of participants|1/1/2008||||milligram of sedative an opiate|||Number
1263499|NCT00409344|Primary|Time to a Successful Spontaneous Breathing Trial.|Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.|1/1/2008||||hours|||Number
1263500|NCT00409331|Primary|12-month Clinically Relevant Salivary Flow (CRSF)|Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.|12 months|No analysis performed; study terminated early due to change in sponsor.||||||
1263501|NCT00409292|Secondary|to Assess Overall Survival Associated With RAD001 in This Patient Population.|Overall survival was defined as the time from study entry until death from any cause.|2 years||||months||Full Range|Median
1263531|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263502|NCT00409292|Secondary|to Assess Response Rate Associated With RAD001 in This Patient Population.|The secondary objectives of the study were to assess tumor response rate and overall survival. Patients were required to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, for target lesions assessed by CT: Complete Response (CR) is Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) equals CR + PR.|2 years|Of the 33 patients enrolled, 29 reached restaging. Three patients who did not reach restaging were removed from study because of withdrawal of consent. One patient was removed from study after 8 days of treatment because of worsening of a preexisting perirectal fistula, requiring surgical intervention.|||participants|||Number
1263503|NCT00409292|Secondary|To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer|Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. The number of patients with treatment-related adverse events are reported.|Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.|A total of 33 eligible patients received at least 1 week of study drug and are included in our toxicity analyses.|||participants|||Number
1263504|NCT00409292|Primary|To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.|"The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment.~The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population."|two months|On the basis of prior studies of 2nd line treatment in metastatic pancreatic cancer, we estimated a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this population.|||participants|||Number
1263505|NCT00409240|Primary|Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study|Hemoglobin A1C target was < 7% LDL cholesterol goal of < 100mg/dl or <70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of <130mm Hg|6 months||||participants|||Number
1263506|NCT00409188|Secondary|Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions|Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator.|From first dose up to 42 days after the last dose of the trial treatment|Safety analysis set included all participants who received at least 1 dose of trial treatment (cyclophosphamide, tecemotide, saline, or placebo). Participants were reported based on the actual treatment received (as-treated).|||participants|||Number
1263507|NCT00409188|Secondary|One-, Two- and Three-year Survival Rate|The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach.|Years 1, 2, and 3|Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.|||percentage of participants|||Number
1263508|NCT00409188|Secondary|Time To Progression (TTP)|Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 [RECIST v1.0]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions.|Up to 66 months|Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.|||months||95% Confidence Interval|Median
1263509|NCT00409188|Secondary|Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)|Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale – ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment.|Up to 66 months|"Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. N signifies the number of participants who were evaluable for this outcome measure."|||months||95% Confidence Interval|Median
1263510|NCT00409188|Primary|Overall Survival|Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier.|Up to 66 months|Primary analysis set (modified intention-to-treat [ITT] population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.|||months||95% Confidence Interval|Median
1263511|NCT00409175|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 8, Month 6, 12, 18|ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||percentage of participants||95% Confidence Interval|Number
1263512|NCT00409175|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, 12 and 18|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation associated with malnutrition. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
1263513|NCT00409175|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6, 12 and 18|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1263514|NCT00409175|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6, 12 and 18|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1263515|NCT00409175|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, 12 and 18|Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale: 0=no problem, 4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment, for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1263516|NCT00409175|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6, 12|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1263517|NCT00409175|Secondary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6 and 12|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to <2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0 (normal) to 4 (paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 6, 12|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. LOCF method was used; participant who discontinued due to death/LT was set non-responder.|||percentage of participants||95% Confidence Interval|Number
1263518|NCT00409175|Secondary|Change From Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) Score at Month 6, 12 and 18|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1263532|NCT00408993|Secondary|Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)|Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.|over 12 weeks|Number of randomized patients in each treatment arm for each dosing group|||participants|||Number
1263519|NCT00409175|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 18|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1263520|NCT00409175|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 18|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than[<] 2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 18|ITTset:randomized participants received atleast(>=)1 dose of study drug, had >=1 post-baseline efficacy assessment for NIS-LL,Norfolk Quality of Life-Diabetic Neuropathy(QOL-DN) or discontinued study due to death/liver transplant(LT).Last-observation-carried-forward(LOCF) used;participant who discontinued due to death/LT was set non-responder.|||percentage of participants||95% Confidence Interval|Number
1263521|NCT00409006|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.|Baseline to date of death from any cause, 12 weeks up to 31 months|Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). Median overall survival could not be estimated as most participants were living at the end of the study.|||Months||95% Confidence Interval|Median
1263522|NCT00409006|Post-Hoc|Percentage of Participants Who Died During the Study|This outcome measure takes the place of the outcome measure for Overall Survival, which could not be reported since the median value could not be calculated.|Baseline up to 31 months|Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). 25 participants from each treatment group were censored.|||Percentage of Participants|||Number
1263523|NCT00409006|Secondary|Duration of Response for Responders|The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.|Time of response to progressive disease or death, 12 weeks up to 31 months|Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy. Patients were censored for this analysis (2 pemetrexed/cisplatin/gefitinib and 2 pemetrexed/cisplatin).|||Months||95% Confidence Interval|Median
1263524|NCT00409006|Secondary|Number of Participants With Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.|Baseline to measured response or death, 12 weeks up to 31 months|Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy.|||Participants|||Number
1263525|NCT00409006|Primary|Progression-Free Survival (PFS)|Defined as the time from randomization to the first observation of disease progression, or death due to any cause.|Baseline to first observation of disease progression or death, 12 weeks up to 31 months|Randomized and treated (RT) population includes all randomized patients. Patients are analyzed according to the treatment they actually received (intent-to-treat [ITT] analysis). Patients were censored from this analysis (8 pemetrexed/cisplatin/gefitinib and 11 pemetrexed/cisplatin).|||Months||95% Confidence Interval|Median
1263526|NCT00408993|Secondary|Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid|Significantly different laboratory values between the two groups in baseline to endpoint changes|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.|||micromole/Liter||Standard Deviation|Mean
1263527|NCT00408993|Secondary|Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides|Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.|||millimole/Liter||Standard Deviation|Mean
1263528|NCT00408993|Secondary|Vital Signs - Blood Pressure|Change from baseline to endpoint in systolic and diastolic blood pressure.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||mm Hg||Standard Error|Least Squares Mean
1263529|NCT00408993|Secondary|Vital Signs - Pulse Rate|Change from baseline to endpoint in pulse rate.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||beats per minute||Standard Error|Least Squares Mean
1263530|NCT00408993|Secondary|Vital Signs - Weight|Change from baseline to endpoint in body weight.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||kilograms||Standard Error|Least Squares Mean
1263534|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire – 5 Dimensions (EQ-5D) (US Based Index Score)|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263535|NCT00408993|Secondary|Time Course of Change in Patient Global Impression - Improvement Scale|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|baseline, over 12 weeks|Intention to Treat analysis. Number of randomized patients with at least one non-missing post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
1263536|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263537|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores|Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263538|NCT00408993|Primary|Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263539|NCT00408928|Secondary|Number of Toxicities Related to Bortezomib (VELCADE®)|Observe the toxicities of VELCADE® when administered to recipients of allogeneic hematopoietic stem cell transplant in the setting of steroid refractory or steroid dependent acute graft-versus-host disease.|Through 30 days post-traeatment||||toxicities|||Number
1263540|NCT00408928|Primary|Response to Bortezomib (VELCADE®)|"Response is the primary endpoint of this study and will be scored on day 21 (3 weeks after the first dose of VELCADE) and every 3 weeks subsequently. Patients who progress or expire before the end of the study will be considered non-responders.~Patients are evaluated for response in an organ if they have AGVHD in that organ at the start of treatment with VELCADE or if AGVHD develops after the start of VELCADE, but before the time period of evaluation. Complete response in an organ is defined as no evidence clinical or biochemical signs of AGVHD. For the overall assessment, it is defined as complete resolution of rash, abnormal LFTs, and absence of diarrhea attributed to AGVHD.~Partial response is defined as a one stage decrease in any organ system without worsening in other organ systems."|Through 30 days post-treatment||||participants|||Number
1263541|NCT00408902|Secondary|Progression-free Survival|Estimated time to progression using the method of Kaplan and Meier.|Up to 4 weeks after completion of study treatment|Intent to treat|||months||Full Range|Median
1263542|NCT00408902|Secondary|Overall Survival|Estimated using the method of Kaplan and Meier.|Followed until progression or death for approximately 3 years|Data was not collected as study closed prior to time period for analysis.||||||
1263543|NCT00408902|Primary|Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden)|The number of patients that reach complete response (CR)defined as the disappearance of all target lesions or partial response (PR)defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Up to 4 weeks after completion of study treatment|Intent to treat|||participants|||Number
1263544|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Weight||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||kilograms||Standard Error|Least Squares Mean
1263545|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||mm Hg||Standard Error|Least Squares Mean
1263546|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||mm Hg||Standard Error|Least Squares Mean
1263547|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||beats per minute||Standard Error|Least Squares Mean
1263548|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||micromole/Liter||Standard Deviation|Mean
1263549|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||millimole/Liter||Standard Deviation|Mean
1263553|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||micromole/Liter||Standard Deviation|Mean
1263554|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||micromole/Liter||Standard Deviation|Mean
1263555|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||millimole/Liter||Standard Deviation|Mean
1263556|NCT00408876|Secondary|Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||Units/Liter||Standard Deviation|Mean
1263557|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||Units/Liter||Standard Deviation|Mean
1263558|NCT00408876|Secondary|Adverse Events Reported as Reason for Discontinuation||Baseline to Week 13|Number of all randomized patients.|||participants|||Number
1263559|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263560|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263561|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263562|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Vitality scores range from 4-24 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263563|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Social functioning scores range from 2-10 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263564|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-physical scores range from 4-8 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263590|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263565|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-emotional scores range from 3-6 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263566|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Physical functioning scores range from 10-30 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263567|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Mental health scores range from 5-30 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263568|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). General health scores range from 5-25(higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263569|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Bodily pain scores range from 2-11 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263570|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263571|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263572|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263573|NCT00408876|Secondary|Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward||Baseline to Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||participants|||Number
1263574|NCT00408876|Secondary|Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward||Baseline to Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||participants|||Number
1263604|NCT00408876|Primary|Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 1|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263575|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263576|NCT00408876|Primary|Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263577|NCT00408876|Primary|Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 12|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263578|NCT00408876|Primary|Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 11|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263579|NCT00408876|Primary|Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 10|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263580|NCT00408876|Primary|Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 9|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263581|NCT00408876|Primary|Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 8|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263582|NCT00408876|Primary|Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 7|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263583|NCT00408876|Primary|Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 6|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263584|NCT00408876|Primary|Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 5|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263585|NCT00408876|Primary|Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 4|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263586|NCT00408876|Primary|Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 3|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263587|NCT00408876|Primary|Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 2|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1263588|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263589|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263591|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263592|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263593|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263594|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263595|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263596|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263597|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263598|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263599|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263600|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score|The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263601|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score|The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263602|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score|Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263603|NCT00408876|Secondary|Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint|"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from~1 (very much better) to 7 (very much worse)."|Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1263605|NCT00408694|Secondary|Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment|Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from start of treatment to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started treatment|||percentage of participants||95% Confidence Interval|Number
1263606|NCT00408694|Secondary|One- and Two-year Overall Survival Rates|Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1263607|NCT00408694|Secondary|One- and Two-year Progression-free Survival Rates|Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as distant metastases.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1263608|NCT00408694|Secondary|One- and Two-year Loco-regional Progression-free Rates|Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started study treatment.|||percentage of participants||95% Confidence Interval|Number
1263609|NCT00408694|Secondary|One- and Two-year Distant Metastases-free Rates|Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1263610|NCT00408694|Secondary|Death During or Within 30 Days of Discontinuation of Protocol Treatment.|The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval.|From start of treatment to 30 days after end of treatment (treatment ends approximately day 109).|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1263611|NCT00408694|Secondary|Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen|Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals.|From start of treatment to end of treatment (approximately day 109).|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1263612|NCT00408694|Secondary|Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.|Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started study treatment and survived more than one year.|||percentage of participants||95% Confidence Interval|Number
1263613|NCT00408694|Primary|Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.|Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to one year.|Eligible patients who started study treatment.|||percentage of participants||95% Confidence Interval|Number
1263614|NCT00408681|Other Pre-specified|Agents Added to Treat GVHD More Than 3 Days After Enrollment|Any systemic medication given in an effort to control graft-versus-host disease|Up to 100 days after enrollment||||Participants|||Count of Participants
1263615|NCT00408681|Secondary|Causes of Death|Medical condition that made the greatest contribution in causing death|up to 6 years after enrollment||||Participants|||Count of Participants
1263616|NCT00408681|Secondary|Survival|Patients who were alive at the specified time point|2 years after enrollment||||Participants|||Count of Participants
1263617|NCT00408681|Secondary|Survival|Patients who were alive at the specified time point|1 year after enrollment||||Participants|||Count of Participants
1263618|NCT00408681|Secondary|Survival|Patients who were alive at the specified time after enrollment|6 months after enrollment||||Participants|||Count of Participants
1263621|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|9 to 11 weeks after starting treatment with the study product|Only 4 patients had endoscopic evaluation during this time window.|||Participants|||Count of Participants
1263622|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|6 to 7 weeks after starting treatment with the study product|Only 3 patients had endoscopic evaluation during this time window.|||Participants|||Count of Participants
1263623|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|5 weeks after starting treatment with the study product|Only 1 patient had endoscopic evaluation during this time window.|||Participants|||Count of Participants
1263624|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|4 weeks after starting treatment with the study product|Only 2 patients had endoscopic evaluation during this time window.|||Participants|||Count of Participants
1263625|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|2 to 3 weeks after starting treatment with the study product|Only 8 of the 20 enrolled patients had endoscopic evaluation during this time window.|||Participants|||Count of Participants
1263626|NCT00408681|Secondary|Duration of Treatment With the Study Product|Number of days from beginning of orally administered lithium carbonate to the end of orally administered lithium carbonate|Up to 6 months||||days||Full Range|Median
1263627|NCT00408681|Primary|Functional Recovery|Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by > 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.|at 28 days after starting treatment with the study product||||Participants|||Count of Participants
1263663|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Weight||Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||kilograms||Standard Deviation|Mean
1264156|NCT00405067|Primary|Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1263628|NCT00408629|Secondary|Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263629|NCT00408629|Secondary|Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263630|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 32, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263631|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Baseline to Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263632|NCT00408629|Secondary|Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"RBS ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263633|NCT00408629|Secondary|Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"SFS ranges from 0-3 as follows:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. The participant served as his/her own control."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263634|NCT00408629|Secondary|Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263635|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Baseline to Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263636|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263637|NCT00408629|Secondary|Proportion of Participants Who Achieved Mucosal Healing at Week 52|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263638|NCT00408629|Secondary|Proportion of Participants Who Achieved Mucosal Healing at Week 8|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263639|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263640|NCT00408629|Secondary|Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263641|NCT00408629|Secondary|Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263642|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263643|NCT00408629|Primary|Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to OL treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263644|NCT00408629|Primary|Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|Intent-to-treat (ITT) analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label (OL) treatment were considered to be non-remission.|||Percentage of Participants|||Number
1263645|NCT00408603|Secondary|Progression-free Survival (PFS) Using Kaplan-Meier Methods|"PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression.~For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules.~For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules.~For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment."|From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period|Safety population which included all patients who received any amount of vosaroxin|||Days||95% Confidence Interval|Median
1263664|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic|Systolic blood pressure measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||mm Hg||Standard Deviation|Mean
1265415|NCT00395486|Secondary|Percentage Change of Insulin Resistance Using HOMA-R|HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
1263646|NCT00408603|Primary|Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria|Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.|GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period|Safety Population which included all patients who received any amount of vosaroxin|||Participants|||Count of Participants
1263647|NCT00408590|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 12 months after last treatment||||Days||Full Range|Median
1263648|NCT00408590|Secondary|Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)|CA-125 tests are measured in units per milliliter (U/mL) and taken every cycle (up to 6-28 day cycles) during treatment and every three months up to 12 months after treatment. The change in CA-125 is calculated as the baseline CA-125 value subtracted by the last recorded value of CA-125 (up to 18 months from baseline.|baseline and up to 18 months||||U/ml||Full Range|Median
1263649|NCT00408590|Secondary|Number of Responses (Complete and Partial, Stable and Progressive Disease)|Responses will be summarized separately for the MV-CEA virus and MV-NIS virus by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. CA125 levels and time to progression will also be summarized descriptively. Modified Response Evaluation Criteria in Solid Tumors(RECIST v1.0) criteria will be used. For target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progression (PD): As least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD|up to 12 months after last treatment||||participants|||Number
1263650|NCT00408590|Primary|Dose Limiting Toxicity|If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose|up to 12 months after last treatment|All patients that received study drug for at least 4 weeks were evaluated for dose limiting toxicities.|||participants with DLTs|||Number
1263651|NCT00408564|Secondary|Determine the Biomarker Response of CA 19-9 to Therapy||from start up treatment to one year after end of treatment, up to 81 weeks|data for this endpoint was not collected.||||||
1263652|NCT00408564|Secondary|Response Duration in Patients With at Least Partial Response to Treatment||up to 46 weeks after the start of study treatment|data for this endpoint was not collected.||||||
1263653|NCT00408564|Secondary|Response Rate|defined as the total number of subjects whose best response is PR or CR.|up to 46 weeks after the start of study treatment|only includes patients who completed at least 2 cycles of induction chemotherapy.|||Participants|||Count of Participants
1263654|NCT00408564|Secondary|Overall Survival||up to 46 weeks after the start of study treatment||||percentage of participants||95% Confidence Interval|Number
1263655|NCT00408564|Secondary|Number of Participants With Grade 3-4 Adverse Events Reported||from start of study treatment until end of study visit, about 30 weeks||||participants|||Number
1263656|NCT00408564|Primary|Progression-free Survival at 6 Months||up to 46 weeks after the start of study treatment|only includes patients who completed at least 2 cycles of induction chemotherapy.|||percentage of participants||95% Confidence Interval|Number
1263657|NCT00408499|Secondary|Patient Outcome|In the Phase II portion of the study, patients will be followed for both disease free progression by capturing disease progression date and for over all survival by capturing death date.|Patients will be followed until death|44 patients were enrolled into the Phase II portion of the study|||Participants|||Count of Participants
1263658|NCT00408499|Primary|Number of Patients Correlated With Best Overall Response.|To determine the efficacy, as measured by objective tumor response rate (RICIST criteria), of daily oral erlotinib and weekly intravenous cetuximab in patients with advanced NSCLC. Best overall response per patient will be reported below.|Every two cycles from first dose to last dose of study drugs||||Participants|||Count of Participants
1263659|NCT00408499|Primary|Number of Patients Experiencing a DLT|Patients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity|baseline through cycle 1 of treatment||||Participants|||Count of Participants
1263660|NCT00408460|Secondary|Overall Survival||Every 3 months for 5 years||||months||Full Range|Median
1263661|NCT00408460|Secondary|Time to Tumor Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Baseline and every 2 months post treatment until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed up to 5 years.||||months||Full Range|Median
1263662|NCT00408460|Primary|Overall Response Rate (Complete and Partial Responses) as Assessed by RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Baseline, Week 4 of courses 2, 4 and 6||||Participants|||Count of Participants
1263665|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic|Diastolic blood pressure measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||mm Hg||Standard Deviation|Mean
1263666|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate|Pulse rate (heart rate) measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||beats per minute||Standard Deviation|Mean
1263667|NCT00408421|Secondary|Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid|Change from baseline to endpoint in uric acid using central laboratory reference ranges.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||micromole/Liter||Standard Deviation|Mean
1263668|NCT00408421|Secondary|Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase|Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||Units/Liter||Standard Deviation|Mean
1263669|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263670|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263671|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263672|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary|A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263673|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary|A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263674|NCT00408421|Secondary|Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase|Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.|Over 13 Weeks|Number of re-randomized patients with non-missing response values.|||participants who responded|||Number
1263707|NCT00408408|Primary|Pathologic Complete Response (pCR) of the Primary Tumor in the Breast|Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.|Time of surgery, on average 6 or 13 months||||percentage of patients||95% Confidence Interval|Number
1265416|NCT00395486|Secondary|Percentage Change of Glucose Level|Using laboratory test, mean change of glucose level was investigated.|Baseline and 6 weeks||||Percentage change||Standard Deviation|Mean
1263675|NCT00408421|Secondary|Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings|Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).|Over 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||participants who responded|||Number
1263676|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263677|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263678|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263679|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263680|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263681|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263682|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263683|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263684|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263871|NCT00406848|Secondary|Change From Baseline on the 30-item Geriatric Depression Scale (GDS)|The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263685|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263686|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263687|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263688|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263689|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis in the re-randomized patients. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263690|NCT00408421|Secondary|Weekly Change From Baseline in the 24-Hour Worst Pain Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.|Over 13 Weeks|Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1263691|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263692|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263693|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263694|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263872|NCT00406848|Primary|Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale|The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).|baseline (Week 1), Week 13|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263695|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
1263696|NCT00408421|Secondary|Patient Global Impression of Improvement at 13 Week Endpoint|A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).|13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1263697|NCT00408421|Primary|Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary|This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).|Over 13 Weeks|Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1263698|NCT00408408|Secondary|Disease-free Survival (DFS)|Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years.|Measured through 5 years after study enrollment|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2B no follow up data for 6 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 3 patients|||percentage of patients||95% Confidence Interval|Number
1263699|NCT00408408|Secondary|Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone|The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics.|24 months after study entry|For Arm 1A there is no followup data for 2 patients; for Arm 2A there is no followup data for 1 patient; for Arm 3A there is no followup data for 3 patients; for Arm 1B there is no followup data for 3 patients; for Arm 2B there is no followup data for 5 patients; and for Arm 3B there is no followup data for 2 patients.|||participants|||Number
1263700|NCT00408408|Secondary|Surgical Complication|Number of patients with Grade 4 or above surgery-related toxicities|24 months after study entry|For Arm 1A there is no follow up data for 8 patients; Arm 1B no follow up data for 8 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 12 patients; Arm 3A no follow up data for 11 patients; Arm 3B no follow up data for 7 patients|||participants|||Number
1263701|NCT00408408|Secondary|Percentage of Cardiac Events||After each cycle, 3-5 weeks postoperative, 9 and 12 months from study entry, every 6 month years 2-5, and annually years 6-10, for postoperative bevacizumab patients, every 6 weeks during postoperative therapy and at 18 months following study entry.|||||||
1263702|NCT00408408|Secondary|Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens|The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST.|Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients|||percentage of patients||95% Confidence Interval|Number
1263703|NCT00408408|Secondary|Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy|Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.|Assessed at cycle 5 of chemotherapy, on average at 15 weeks|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients|||percentage of patients||95% Confidence Interval|Number
1263704|NCT00408408|Secondary|Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens|The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST.|Three to four weeks after the last chemotherapy dose on average 6 or 13 months|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients|||percentage of patients||95% Confidence Interval|Number
1263705|NCT00408408|Secondary|Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy|Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.|Assessed at cycle 5 of chemotherapy, on average at 15 weeks|For Arm 1A there is no follow up data for 1 patient; Arm 1B no follow up data for 5 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 7 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 4 patients|||percentage of patients||95% Confidence Interval|Number
1263706|NCT00408408|Secondary|pCR in the Breast and Nodes|Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.|Time of surgery, on average 6 or 13 months|Arm 1A there is no follow up data for 3 patients; Arm 1B no follow up date for 6 patients; Arm 2A no follow up data for 1 patient; Arm 2B no follow up data for 11 patients; Arm 3A no follow up data for 9 patients; and Arm 3B no follow up data for 6 patients|||percentage of patients||95% Confidence Interval|Number
1292593|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population||Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1263708|NCT00408317|Other Pre-specified|Percentage of Stool Categorized by Consistency|Stool consistency was categorized as hard, formed/normal, soft or watery stool. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency on Day 4 for the first treatment period and second treatment period period for total participants was summarized.|Day 4 on first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.|||percentage of stools||Standard Deviation|Mean
1263709|NCT00408317|Other Pre-specified|Number of Bowel Movements|Number of bowel movements of each participant was calculated from frequency of stools by the participant per day. Mean daily number of bowel movements on Day 3 for the first treatment period and second treatment period was summarized.|Day 3 on first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.|||bowel movements||Standard Deviation|Mean
1263710|NCT00408317|Secondary|Percent Coefficient of Nitrogen Absorption (CNA)|Percent (%) CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Nitrogen intake was calculated as protein intake/6.25. Mean percent CNA was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.|Day 3 to Day 7 in first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.|||Percent CNA||Standard Deviation|Mean
1263711|NCT00408317|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent (%) CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Mean CFA percent was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.|Day 3 to Day 7 in first intervention period and second intervention period|Intent-to-Treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.|||Percent CFA||Standard Deviation|Mean
1263712|NCT00408200|Secondary|Freedom From Atrial Arrhythmia at 6 Months Post Procedure.||6 weeks|Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.|||participants|||Number
1263713|NCT00408200|Primary|Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug||6 weeks|Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.|||participants|||Number
1263714|NCT00408070|Secondary|Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy||12 months|not assessed; study terminated early||||||
1263715|NCT00408070|Secondary|To Determine the Degree and Type of Toxicity of This Combined Regimen||weekly|not assessed; study terminated early||||||
1263716|NCT00408070|Secondary|Rate of Decline of CA-125||12 months|not assessed; study terminated early||||||
1263717|NCT00408070|Secondary|Response to Treatment (Clinical/Pathological)||12 months|not assessed; study terminated early||||||
1263718|NCT00408070|Primary|Progression Free Survival Rate at 9 Months|This Outcome is measuring the number of particpants who have survived.|9 months||||participants|||Number
1263719|NCT00407966|Primary|Complete Response|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an Absolute Neutrophil Count of at least 1000/mililiter and a platelet count of 100,000 mililiter, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A complete remission must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the complete remission.|6 months|Total number of participants entered between December 2006 and June 2008|||participants|||Number
1263720|NCT00407888|Secondary|Overall Survival|Count of surviving patients at two years and six years|Up to 6 years.||||Participants|||Count of Participants
1263721|NCT00407888|Secondary|Time to Treatment Failure|Median time from date of start of therapy to date of removal from therapy for reason other than completion, date of first observation of recurrent disease or date of death due to any cause whichever comes first.|Up to 6 years|Outcome measure reported only for those that had an event (death, recurrent disease or removal).|||years||Full Range|Median
1263722|NCT00407888|Secondary|Toxicity Associated With This Regimen||After at least one course of Adriamycin, up to 12 weeks.|Some results reported are only considered amongst patients receiving Trastuzumab (n = 15).|||Participants|||Count of Participants
1263723|NCT00407888|Secondary|Delivered Dose Intensity of the Regimen||After at least one course of Adriamycin, up to 12 weeks.||||percentage of mean administered dose|||Number
1263724|NCT00407888|Primary|Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin||2 years||||Participants|||Count of Participants
1263725|NCT00407797|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS)|Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.|||scores on scale||Standard Deviation|Mean
1263726|NCT00407797|Secondary|Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale|Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b.|Week 21, LOCF|FAS. LOCF=Last Observation Carried Forward.|||scores on scale||Standard Deviation|Mean
1263727|NCT00407797|Secondary|Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)|Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.|||scores on scale||Standard Deviation|Mean
1263728|NCT00407797|Secondary|Treatment Satisfaction: Patient General Impression to Change (PGIC)|Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.|||percent of participants|||Number
1263729|NCT00407797|Secondary|Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period||Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.|||percent of participants|||Number
1263730|NCT00407797|Secondary|Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period||Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.|||percent of participants|||Number
1263731|NCT00407797|Secondary|Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period|Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).|Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.|||percent of participants|||Number
1263732|NCT00407797|Secondary|Percent of Seizure- Free Participants During the Treatment Observation Period|Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).|Week 9 to Week 21 or Early Termination (end of treatment)|FAS. N=number of subjects with evaluable data.|||percent of participants|||Number
1263733|NCT00407797|Secondary|Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period|Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.|Week 9 to Week 21 or End of Treatment (early termination)|FAS. N=number of subjects with evaluable data.|||percent change||Standard Deviation|Mean
1263734|NCT00407797|Secondary|Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21|Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.|Week 21 or End of Treatment (early termination)|FAS.|||percent change||Standard Deviation|Mean
1263735|NCT00407797|Secondary|Response Ratio (RR)|Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.|Week 9 to Week 21 or End of Treatment (early termination)|FAS. N=number of subjects with evaluable data.|||ratio||Standard Deviation|Mean
1263736|NCT00407797|Primary|Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase|28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.|Week 9 to Week 21 or End of Treatment (early termination)|Full Analysis Set (FAS): all subjects who received at least 1 dose of assigned treatment, had valid baseline seizure data, and had at least 1 subsequent rating of seizure frequency (modified intent to treat population). N=number of subjects with evaluable data.|||percent change||Standard Deviation|Mean
1263737|NCT00407758|Secondary|Prognostic Factor - Age at Study Entry||Baseline|Eligible and treated patients|||years||Inter-Quartile Range|Median
1263738|NCT00407758|Secondary|Prognostic Factor - Initial Performance Status|Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work|Baseline|Eligible and treated patients|||Participants|||Count of Participants
1263739|NCT00407758|Secondary|Prognostic Factor - Number of Patients With Platinum Sensitivity|Platinum sensitive = a platinum-free interval between 6 and 12 months.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
1263749|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263740|NCT00407758|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients|||months||90% Confidence Interval|Median
1263741|NCT00407758|Secondary|Duration Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients|||months||90% Confidence Interval|Median
1263742|NCT00407758|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients|||Participants|||Count of Participants
1263743|NCT00407758|Primary|Progression-free Survival > 6 Months Using RECIST 1.0|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients|||Participants|||Count of Participants
1263744|NCT00407758|Primary|Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.|CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients|||Participants|||Count of Participants
1263745|NCT00407745|Secondary|Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263746|NCT00407745|Secondary|Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263747|NCT00407745|Secondary|Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
1263748|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263772|NCT00407745|Secondary|Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
1265544|NCT00394901|Primary|Mean Pain Scores at Week 4|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week4|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1263750|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263751|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263752|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263753|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263754|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263755|NCT00407745|Secondary|Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)|NPSI – Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.|Baseline, Week 16|MITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
1263756|NCT00407745|Secondary|Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)|NPSI – Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.|Baseline, Week 16|MITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
1263757|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263758|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263759|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263760|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263761|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263762|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF;(n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263763|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263764|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales|Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263765|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263766|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli|Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263767|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia|Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263768|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263769|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263770|NCT00407745|Secondary|Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score|The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from “does not interfere” (0) to “completely interferes” (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263771|NCT00407745|Other Pre-specified|Change From Baseline in Weekly Mean Sleep Interference Score by Week|Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).|Baseline, Week 1 through 16|ITT; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1265545|NCT00394901|Secondary|Number of Patients Not Reporting Hyperalgesia|Participants not reporting hyperalgesia.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||participants|||Number
1263773|NCT00407745|Secondary|Change From Baseline in Weekly Mean Pain Score by Week|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 1 through16|ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis.|||score on scale||Standard Deviation|Mean
1263774|NCT00407745|Secondary|Change From Baseline in Weekly Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
1263775|NCT00407745|Secondary|Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)|The PGIC is a participant-rated instrument measuring change in the participant’s overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
1263776|NCT00407745|Secondary|Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint.|||participants|||Number
1263777|NCT00407745|Secondary|Change From Baseline in Weekly Mean Pain Score|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants.|||score on scale||Standard Deviation|Mean
1263778|NCT00407745|Primary|Duration Adjusted Average Change (DAAC) of Mean Pain Score|DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.|Baseline, Week 16|mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2.|||score on scale||Standard Error|Least Squares Mean
1263779|NCT00407654|Secondary|Number of Participants With Response (Bevacizumab-treated Group)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;~Stable disease for atleast 16 weeks"|Up to 6 years||||participants|||Number
1263780|NCT00407654|Secondary|Overall Survival (Bevacizumab-treated Group)|Kaplan-Meier method will be used (Bevacizumab-treated Group)|12 months||||months||95% Confidence Interval|Median
1263781|NCT00407654|Secondary|Overall Survival (Bevacizumab-treated Group)|Kaplan-Meier method will be used. (Bevacizumab-treated Group)|6 months||||months||95% Confidence Interval|Median
1263782|NCT00407654|Secondary|Number of Participants With Response (Bevacizumab-naïve Group)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;~Stable disease for atleast 16 weeks"|Up to 6 years||||participants|||Number
1263783|NCT00407654|Secondary|Objective Stable Disease Rate||Up to 6 years|data were not collected||||||
1263784|NCT00407654|Secondary|Time to Progression|Kaplan-Meier method will be used.|12 months|data were not collected||||||
1263785|NCT00407654|Secondary|Overall Survival (Prior Bevacizumab Treated Group)|Kaplan-Meier method will be used (Bevacizumab-naïve Group)|12 months||||months||95% Confidence Interval|Median
1263786|NCT00407654|Secondary|Overall Survival (Bevacizumab-naïve Group)|Kaplan-Meier method will be used. (Bevacizumab- naïve Group)|12 months||||months||95% Confidence Interval|Median
1263787|NCT00407654|Primary|Progression-free Survival (Bevacizumab-treated Group)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~Kaplan-Meier method will be used. Progression-free survival (Bevacizumab-treated group)"|4 months||||months||95% Confidence Interval|Median
1263788|NCT00407654|Primary|Progression-free Survival (Bevacizumab- naïve Group)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~Kaplan-Meier method will be used.Progression-free survival (Bevacizumab- naïve group)"|4 months||||months||95% Confidence Interval|Median
1263789|NCT00407654|Primary|Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 6 years||||participants|||Number
1263806|NCT00407537|Secondary|Mean Lipid Parameters at Month 4|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.|||mg/dL||Standard Deviation|Mean
1263807|NCT00407537|Secondary|Change From Baseline in DBP at Month 12||Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||mmHg||95% Confidence Interval|Least Squares Mean
1265546|NCT00394901|Secondary|Number of Patients Not Reporting Allodynia|Participants not reporting allodynia.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||participants|||Number
1263790|NCT00407563|Secondary|Best Overall Response at Six Months|The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.|Assessed over 6 months of study treatment|The 2 tailed, 95% confidence interval of the estimated response rate was calculated using the normal approximation to the binomial distribution.|||percentage of patients||95% Confidence Interval|Number
1263791|NCT00407563|Secondary|Progression-free Survival (PFS)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.|Participants who had not experienced either disease progression or death during or after stopping treatment were censored in the analysis.|||Months||95% Confidence Interval|Median
1263792|NCT00407563|Secondary|Overall Survival||Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.|Participants who had not experienced death during or after stopping treatment were censored in the analysis.|||Months||95% Confidence Interval|Median
1263793|NCT00407563|Secondary|Best Overall Response|Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.|Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.||||Participants|||Number
1263794|NCT00407563|Primary|6-month Progression-Free Rate|Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|6 months after initiation of study treatment||||percentage of patients||95% Confidence Interval|Number
1263795|NCT00407550|Secondary|Adverse Event|Number of patients that experienced adverse events (grade 4 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years)|||||||
1263796|NCT00407550|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Death or last follow-up (up to 2 years)|||||||
1263797|NCT00407550|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.|Time from registration to progression or death (up to 2 years)|||||||
1263798|NCT00407550|Primary|Number of Patients With Confirmed Responses|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.~>~> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|Two consecutive evaluations at least 6 weeks apart (up to 2 years)||||participants|||Number
1263799|NCT00407537|Secondary|Number of Participants With Increase of Treatment Dosages After 4 Months.|Treatments indicative of prescribed medications other than study provided Caduet.|Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.|||Participants|||Number
1263800|NCT00407537|Secondary|Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months|Treatments indicative of prescribed medications other than study provided Caduet.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||participants|||Number
1263801|NCT00407537|Secondary|Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months|Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||Percentage of participants|||Number
1263802|NCT00407537|Secondary|Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months|Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||percentage of participants|||Number
1263803|NCT00407537|Secondary|Change From Baseline in Lipid Parameters at Month 12|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1263804|NCT00407537|Secondary|Change From Baseline in Lipid Parameters at Month 4|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1263805|NCT00407537|Secondary|Mean Lipid Parameters at Month 12|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||mg/dL||Standard Deviation|Mean
1263813|NCT00407537|Secondary|Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.|Baseline, Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||95% Confidence Interval|Least Squares Mean
1263814|NCT00407537|Secondary|Change From Baseline in Framingham 10-year Risk of Developing Total CHD|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.|Baseline, Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||95% Confidence Interval|Least Squares Mean
1263815|NCT00407537|Secondary|Framingham 10-year Risk of Stroke at Month 4|Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific “calibration factor” for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
1263816|NCT00407537|Secondary|Framingham 10-year Risk of Stroke at Month 12|Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific “calibration factor” for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
1263817|NCT00407537|Secondary|European SCORE 10-year Risk of Fatal CVD at Month 4|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
1263818|NCT00407537|Secondary|European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
1263819|NCT00407537|Secondary|Framingham 10-year Risk of Total CHD at Month 4|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
1263820|NCT00407537|Primary|Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 12|Full Analysis Set (FAS) included all subjects, in either treatment group, who had blood pressure and lipid data from at least 1 follow-up visit. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
1263821|NCT00407511|Secondary|Clinical Global Impression of Change (CGIC)|7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).|End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)|Full Analysis Set (FAS)|||participants|||Number
1263822|NCT00407511|Secondary|Patient Global Impression of Change (PGIC)|7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)|End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)|Full Analysis Set (FAS)|||participants|||Number
1263823|NCT00407511|Secondary|Change From Baseline in Mean Daily Sleep Interference Score (DSIS)|Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
1263824|NCT00407511|Secondary|Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)|100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
1263825|NCT00407511|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)|100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
1271387|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16|Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose|After 16 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1263826|NCT00407511|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.|||scores on scale||Standard Deviation|Mean
1263827|NCT00407511|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.|||scores on scale||Standard Deviation|Mean
1263828|NCT00407511|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores|Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.|Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
1263829|NCT00407511|Secondary|Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
1263830|NCT00407511|Secondary|Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)|11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.|Week 4, Week 8, Week 12|Full Analysis Set (FAS).|||scores on scale||Standard Deviation|Mean
1263831|NCT00407511|Primary|Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)|11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.|Baseline, End of Treatment|Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).|||scores on scale||Standard Deviation|Mean
1263832|NCT00407485|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions PFS using the product-limit method of Kaplan and Meier.|From start of treatment to time of progression, assessed up to 4 months||||Months||95% Confidence Interval|Median
1263833|NCT00407485|Primary|Tumor Response Rate|"Response rate (RR) and progression free survival (PFS) were assessed in a 2-stage accrual design (22+18). A maximum of 40 patients were to be accrued to rule out a null hypothesized RR of 4% and PFS of 3 months versus alternative of 15% RR and 5.4 months PFS (corresponding to 4 month PFS of 40% vs 60%) with α=0.12 and β=0.19. If no more than 1 objective response (no more than 4.5%), and no more than 10 instances of 4-month PFS (no more than 45%), were observed among the initial 22 patients, the study would be terminated early and declared negative. Tumor response was evaluated by CT or MRI using RECIST v1.0 criteria.~Responders were confirmed partial or complete responses to treatment."|From the start of the treatment until disease progression or recurrence, assessed up to 4 years||||percentage of responders||95% Confidence Interval|Number
1263834|NCT00407381|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6|Mean change of best corrected visual acuity letters (BCVA) at month 6|6 months|Mean change in BCVA at month 6|||Mean letter change in BCVA||Standard Deviation|Mean
1263835|NCT00407355|Primary|Retinal Thickness Change From Baseline at All Visits||continuous through 72 mos||||microns||Standard Deviation|Mean
1263836|NCT00407355|Primary|Best Corrected Visual Acuity Change From Baseline at All Visits||continuous through 72 mos||||ETDRS letters||Standard Deviation|Mean
1263837|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Error|Least Squares Mean
1263977|NCT00406315|Primary|Change From Baseline in Weight at Week 16|Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.|Baseline, Week 16, Week 16 LOCF|Safety population = all enrolled subjects who took at least 1 dose of study medication. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||kilogram||Standard Deviation|Mean
1263838|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Error|Least Squares Mean
1263839|NCT00407030|Secondary|Patient Evaluation of Global Response (PEGR) at Final Visit|"The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4)."|Final visit (up to 20 weeks after injection of the Main Period)|"Intention to treat population with missing values imputed by no effect"|||points on a scale||Standard Deviation|Mean
1263840|NCT00407030|Secondary|Change From Baseline in the TWSTRS Pain Subscore|TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Deviation|Mean
1263841|NCT00407030|Secondary|Change From Baseline in the TWSTRS Severity Subscore|TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Deviation|Mean
1263842|NCT00407030|Secondary|Change From Baseline in the TWSTRS Disability Subscore|TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Deviation|Mean
1263843|NCT00407030|Secondary|Change From Baseline in the TWSTRS-Total Score|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Deviation|Mean
1263844|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Error|Least Squares Mean
1263845|NCT00406848|Secondary|Change From Baseline on Cognitive Test Scores: Verbal Learning and Recall Test (VLRT), Symbol Digit Substitution Test (SDST), Trail Making Test (Part B), 2-Digit Cancellation Test (2DCT), and the Composite Cognitive Score Derived From the Above Scores|The cognitive assessment battery is composed of four tests: Verbal Learning (score 0-15)and Delayed Recall(score 0-15) test, SDST(Score 0-133),2DCT(score 0-40),Trail Making(Part B)(score 0-180).They are designed to challenge the patient's abilities in the following areas: verbal learning and memory; attention to visually presented material; and working memory and executive function. Composite Cognitive score(0-51)is derived from normalized individual test scores. For Trail Making Test,lower number indicates better cognition. For all other test scores,higher number indicates better cognition.|baseline (Week 1), Week 9, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263846|NCT00406848|Secondary|Number of Participants With Successful Treatment Outcome|Successful treatment outcome defined as: Participant completed the study and being in remission (HAMD-17 Total score ≤7 and ≤10) at least for the last two visits (4 weeks)of the study. The HAMD-17 is used to assess the severity of depression. The total score ranges from 0 (not at all depressed) to 52 (severely depressed).|Baseline (Week 1) through Week 25|All participants randomized under protocol amendment c,d,e, and that have non-missing successful treatment values.|||participants|||Number
1263847|NCT00406848|Secondary|Change From Baseline in Electrocardiograms|The Electrocardiogram measures include the following time intervals: QT interval, QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF), QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB), PR interval and QRS interval.|baseline (Week 1), Week 25|Participants with a baseline and at least one non-missing post baseline value.|||millisecond (msec)||Standard Error|Least Squares Mean
1263978|NCT00406276|Primary|Time to Progression:Time Period (in Months) From Study Entry Until Disease Progression, Death, or Last Date of Contact.|"Period from study entry until disease progression, death, or last date of contact.~Progressive Disease: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|6 months||||Months||Full Range|Median
1263848|NCT00406848|Secondary|Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count|The number of participants with abnormal laboratory values at any time during the study period. Results are reported for laboratory analytes that exhibited statistically significantly different proportions of participants who had abnormal values between treatment groups. Statistical significance was considered at the 0.05 level. The lower limit of normal for leukocyte count is 3.8 Billion/Liter. Participants who had a value below that number were considered to have abnormally low leukocyte count.|baseline (Week 1) through Week 13|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.|||participants|||Number
1263849|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Chloride and Fasting Glucose|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||millimole/liter||Standard Deviation|Mean
1263850|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Hemoglobin, Mean Cell Hemoglobin Concentration (MCHC)|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||Micromole/liter (Fe)||Standard Deviation|Mean
1263851|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Erythrocyte Count|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||Trillion/Liter||Standard Deviation|Mean
1263852|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Uric Acid|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||micromole/liter||Standard Deviation|Mean
1263853|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Platelet Count|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||billions per liter (bill/L)||Standard Deviation|Mean
1263854|NCT00406848|Secondary|Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation|Adverse Events and Serious Adverse Events leading to study discontinuation.|baseline (Week 1) through Week 25|All randomized patients.|||participants|||Number
1263855|NCT00406848|Secondary|Number of Participants Experiencing Sustained Hypertension (SH) or Orthostatic Hypotension (OH)|Sustained Hypertension is defined as supine systolic BP >= 140 (or diastolic BP >= 90) mm Hg and increase from baseline (highest value in baseline visit interval) >= 10 mm Hg for 3 or more consecutive visits in postbaseline visit interval. Orthostatic Hypotension is defined as standing diastolic BP at least 10 mm Hg less than the supine diastolic BP or the standing systolic BP at least 20 mm Hg less than the supine systolic BP at any time in postbaseline visit interval and a patient does not meet this criterion at any visit in baseline interval.|baseline (Week 1) through Week 25|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.|||Participants|||Number
1263856|NCT00406848|Secondary|Number of Participants With Abnormal Vital Signs and Weight at Any Time During the Study|"A patient has a treatment-emergent elevated supine systolic blood pressure if the value is ≥140 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine diastolic blood pressure if the value is ≥90 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine pulse if the value is ≥100 with an increase ≥10 from baseline.~A patient has abnormal weight change if the gain or loss is ≥7% compared to baseline."|Baseline (Week 1) through Week 25|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.|||Participants|||Number
1263857|NCT00406848|Secondary|Change From Baseline in Weight||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.|||kilograms (kg)||Standard Error|Least Squares Mean
1263858|NCT00406848|Secondary|Change From Baseline in Pulse Rate||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1263859|NCT00406848|Secondary|Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.|||mmHg||Standard Error|Least Squares Mean
1263860|NCT00406848|Secondary|Probability of Efficacy Onset as Measured by at Least 20% Sustained Reduction From Baseline in the HAMD-17 Maier Subscale at Week 3|Patients are considered to have met onset (visitwise binary outcome, yes/no) criteria at a particular visit if they had at least 20% reduction from baseline in the HAMD-17 Maier subscale at that visit and at all subsequent visits in the acute phase. Maier subscale measures core symptoms of depression and scores range from 0 (normal) to 24 (severe). The visitwise probability of patients meeting onset criteria was analyzed using a categorical, pseudo-likelihood-based repeated measures approach.|Week 3|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||Probability of onset||Standard Error|Least Squares Mean
1263870|NCT00406848|Secondary|Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items|Total Score assess depression severity (scores 0-52). Core, Maier and Bech subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier; 0-22=Bech). Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher numbers indicate more severe symptoms.|baseline (Week 1), Week 13, Week 25|Randomized patients with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
1263861|NCT00406848|Secondary|Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 by Medical Comorbidity Severity as Assessed by the Cumulative Illness Rating Scale-Geriatric Version (CIRS-G)|Remission defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. Total score ranges: 0 (normal) to 52 (severe depression). Visitwise probability of patients achieving remission was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. CIRS-G evaluates 14 organ-specific categories using a rating strategy of 0=no problems; 1=current mild problem/past significant problem; 2=moderate disability/morbidity; 3=severe/constant significant disability; and 4=extremely severe/immediate treatment required/end organ failure. Total score ranges: 0 to 56.|Week 13, Week 25|Randomized patients with non-missing data at baseline and post-baseline visit.|||probability of remission||Standard Error|Least Squares Mean
1263862|NCT00406848|Secondary|Probability of Response at Endpoint as Measured by ≥50% Improvement in the HAMD-17 Total Score|Response (visitwise binary outcome, yes/no) is defined as ≥ 50% reduction from baseline in the HAMD-17 total score. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for response was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||probability of response||Standard Error|Least Squares Mean
1263863|NCT00406848|Secondary|Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10|Remission (visitwise binary outcome, yes/no) is defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for remission (either Total Score ≤7 or ≤10) was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||probability of remission||Standard Error|Least Squares Mean
1263864|NCT00406848|Secondary|Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF)|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) measures the degree of enjoyment and satisfaction experienced in various areas of daily life. The short version is a self-administered 16 item scale evaluating satisfaction of general activities on a 5-point Likert scale that indicates the degree of enjoyment or satisfaction achieved during the past week (1 = very poor and 5 = very good).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263865|NCT00406848|Secondary|Change From Baseline in the Mini-Mental State Exam (MMSE)|Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. Scores range from 0 to 30. The MMSE will be used to categorize patients as with or without dementia. Higher number indicates better cognitive ability. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia.|baseline (Week 1), Week 9, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263866|NCT00406848|Secondary|Change From Baseline in the Clinical Global Impression-Severity (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263867|NCT00406848|Secondary|Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks|The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “very much improved,” a score of 4 indicates that the patient has experienced “no change,” and a score of 7 indicates that the patient is “very much worse.”|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263868|NCT00406848|Secondary|Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores|Numeric Rating Scales (Semantic Differential Scales) for Pain are 6 self-administered scales that assesses experience of overall pain, back pain, headache, shoulder pain, time in pain while awake, and pain interference with daily activities, during the past week. Each item is scored on a numeric 11-point semantic differential scale (0-10) from 0 = no pain to 10 = pain as severe as you can imagine; or 0 = none of the time to 10 = all of the time; or 0 = no interference to 10 = unable to do any activities at all.|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263869|NCT00406848|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores|The Brief Pain Inventory (severity and interference scales) (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
1263994|NCT00406133|Other Pre-specified|Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)|A relative increase in A1c level by >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263873|NCT00406783|Other Pre-specified|Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE|The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.|Baseline|Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.|||scores on a scale||Standard Error|Least Squares Mean
1263874|NCT00406783|Other Pre-specified|Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE|AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).|Baseline|Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.|||scores on a scale||Standard Error|Least Squares Mean
1263875|NCT00406783|Secondary|Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit|The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.|15 days|Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.|||scores on a scale||Standard Error|Least Squares Mean
1263876|NCT00406783|Primary|The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15|AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).|15 days|Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.|||scores on a scale||Standard Error|Least Squares Mean
1263877|NCT00406718|Secondary|Schizophrenia Symptoms|Brief Psychiatric Rating Scale (BPRS) expanded version psychosis subscale, mean of items for unusual thought content, auspiciousness, conceptual disorganization, and hallucinations. Higher scores mean greater level of symptomatology. Scores vary from 1 = absent to 7 = severe|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|All subjects with a baseline and at least one follow up rating|||units on a scale||Standard Deviation|Mean
1263878|NCT00406718|Primary|Social and Occupational Functioning Assessment Scale (SOFAS) Scores|Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|Patients with baseline and at least one follow up rating|||Units on a scale||Standard Deviation|Mean
1263879|NCT00406718|Primary|Adherence|Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|All individuals randomized who had a baseline and at least one follow-up rating|||Percentage of medication taken||Standard Deviation|Mean
1263880|NCT00406692|Secondary|Symbol Digit Modalities Test (DSMT)|Number of correct digit substitutions on the DSMT per session with the possible maximum score being 188. The value shown is for difference between mean scores obtained for baseline and week 12 sessions.|Baseline, Week 12|ITT|||Units on a scale||Standard Error|Mean
1263881|NCT00406692|Primary|Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).|Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.|Week 0- Baseline and Week 12|ITT|||Number of Words||Standard Error|Mean
1263882|NCT00406692|Primary|The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase|The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.|Baseline and Week 12|ITT|||Standard Drinks||Standard Error|Mean
1263883|NCT00406653|Secondary|OL; Number of Participants With Pharmacogenomic Marker Activity|Changes in the expression of individual ribonucleic acid (RNA) transcripts were to be evaluated from whole blood using both microarray transcriptional profiling and quantitative polymerase chain reaction (PCR) methods. Peripheral RNA transcriptional profiling was to be used only to identify individual RNA transcripts that differ in expression with respect to time, treatment and outcome.|Between Day OL-1 and Day OL-617|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of pharmacogenomic marker activity in participants was not conducted for the OL as planned.|||participants|||Number
1263884|NCT00406653|Secondary|OL; Number of Participants With Positive Antibody Response to Abatacept|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.|||participants|||Number
1271388|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12|Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose|After 12 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1263885|NCT00406653|Secondary|OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day OL-365|All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.|||participants|||Number
1263886|NCT00406653|Secondary|OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day OL-169|All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.|||participants|||Number
1263887|NCT00406653|Secondary|OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy|Background corticosteroid therapy included prednisone or budesonide.|Between Day OL-1 and Day OL-617|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of corticosteroid use in participants was not conducted for the OL as planned.|||participants|||Number
1263888|NCT00406653|Secondary|MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical remission in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||participants|||Number
1263889|NCT00406653|Secondary|MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical response in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||participants|||Number
1263890|NCT00406653|Secondary|MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among Participants Who Received Baseline Corticosteroid Therapy and Who Achieved CDAI-Defined Clinical Remission|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score is based partly on entries from participant’s Diary (7 days before evaluation) which is kept while on study. CDAI scores range from 0 to ~600. Clinical response=CDAI reduction ≥100 or absolute CDAI <150. Clinical remission=CDAI <150. Moderate to severe disease=CDAI ≥220 and ≤450.|Day MP-365|On/after Day MP-1, a defined tapering of corticosteroids was planned if the participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.|||participants|||Number
1263891|NCT00406653|Secondary|MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy|Participants who received corticosteroid therapy (e.g. prednisone or budesonide) were to maintain a stable dose until Day MP-1. On or after Day MP-1, a recommended tapering regimen of corticosteroid therapy was planned if the participant was in remission (i.e., CDAI score < 150), or if the participant’s condition had satisfactorily improved according to investigators clinical assessment. Other CD therapy was to remain at a stable dose throughout the Maintenance Period, with the exception of decreases due to drug-related toxicities.|Day MP-365|On/after Day MP-1, a recommended tapering of corticosteroids was planned if participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned|||participants|||Number
1263920|NCT00406640|Secondary|Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week|CGI-S is a global rating scale that measures the severity of a patient’s disease. Using a 7-point scale, the clinician rates the severity of the patient’s mental illness at the time of the assessment, relative to the clinician’s experience with patients who have the same diagnosis (1= normal; 7= extremely ill).|Baseline and 8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
1263892|NCT00406653|Secondary|MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ)|The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-baseline - Baseline value.|Baseline, Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.|||units on a scale||Standard Deviation|Mean
1263893|NCT00406653|Secondary|MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline, Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.|||units on a scale||Standard Deviation|Mean
1263894|NCT00406653|Secondary|MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-169|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for the cohort of participants with clinical remission at both Day MP-169 and Day MP-365 was not conducted for the MP as planned.|||participants|||Number
1263895|NCT00406653|Primary|OL; Number of Participants With Adverse Events (AEs) of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Between Day OL-1 and Day OL-617|All participants who received at least 1 infusion of open-label study medication at any time, based on a participant’s received treatment (As Treated Analysis Population)|||participants|||Number
1263896|NCT00406653|Secondary|MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
1263897|NCT00406653|Secondary|MP; Number of Participants With Positive Antibody Response to Abatacept|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants not entering OL: All measurements after Day MP-1 (including follow-up visits); For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population. The placebo group was constituted by participants who received abatacept in the IP and underwent drug withdrawal in the MP.|||participants|||Number
1263898|NCT00406653|Secondary|MP; Number of Participants With Adverse Events (AEs) of Special Interest:|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Between Day IP-85 and Day MP-365|All participants who received at least 1 infusion of study medication during the MP, based on a participant’s received treatment (As Treated Analysis Population)|||participants|||Number
1263921|NCT00406640|Secondary|Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
1271389|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8|Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose|After 8 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1263899|NCT00406653|Secondary|MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Between Day IP-85 and Day MP-365|All participants who received at least 1 infusion of study medication during the Maintenance Period, based on a participant’s received treatment (As Treated Analysis Population)|||Participants|||Number
1263900|NCT00406653|Secondary|IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
1263901|NCT00406653|Secondary|IP; Number of Participants in CDAI-Defined Clinical Remission at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-TNF|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
1263902|NCT00406653|Secondary|IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
1263903|NCT00406653|Secondary|IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition identified specific anti-ABA reactivity. Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig) category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85); For participants treated in OL directly after IP: Day IP-1 to Day OL-1; For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.|||participants|||Number
1263904|NCT00406653|Secondary|IP; Number of Participants With Adverse Events (AEs) of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day IP-1 through Day IP-85|All participants who received at least 1 infusion of study medication during the IP, based on a participant’s received treatment (As Treated Analysis Population)|||participants|||Number
1263922|NCT00406640|Secondary|Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||Percentage of patients|||Number
1292594|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population||Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1263905|NCT00406653|Secondary|IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day IP-1 through Day IP-85|All participants who received at least 1 infusion of study medication during the Induction Period, based on a participant’s received treatment (As Treated Analysis Population)|||Participants|||Number
1263906|NCT00406653|Secondary|IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)|The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-Baseline - Baseline value.|Baseline, Day IP-85|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period with both Baseline and post-Baseline measurements.|||units on a scale||Standard Deviation|Mean
1263907|NCT00406653|Secondary|IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period|||participants|||Number
1263908|NCT00406653|Secondary|IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period|||participants|||Number
1263909|NCT00406653|Primary|Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Between Day OL-1 and Day OL-617|All participants who received at least 1 infusion of open-label study medication at any time, based on a participant’s received treatment (As Treated Analysis Population). The OL was not sized based on power considerations.|||participants|||Number
1263910|NCT00406653|Primary|Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365 (12 months) of maintenance therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. The Maintenance Period was not sized based on power considerations, and thus, no formal statistical hypothesis testing was performed.|||participants|||Number
1263911|NCT00406653|Primary|Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
1263912|NCT00406640|Secondary|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper.|6 months|Safety population: Randomized patients who took ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with < 4 wks therapy. Patients analyzed varied by time (DVS SR, ESC): End of Therapy (n=264, 267); Taper week 1 (n=217, 227); Taper week 2 (n=222, 223); Post-taper (n=219, 223).|||units on scale||Standard Deviation|Mean
1263913|NCT00406640|Secondary|Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase|Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.|||Percentage of Non-Responders|||Number
1263914|NCT00406640|Secondary|Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase|Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.|||Percentage of Non-Responders|||Number
1263915|NCT00406640|Secondary|Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase|Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with baseline HAM-D17 score ≥18, who took ≥1 dose study drug, had ≥1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) but not remission (HAM-D17 score ≤ 7) at the end of the acute phase and continued treatment in the 6-month DB continuation phase.|||percentage of responders|||Number
1263916|NCT00406640|Secondary|Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)|Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.|||percentage of responders|||Number
1263917|NCT00406640|Secondary|Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)|Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.|||percentage of responders|||Number
1263918|NCT00406640|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|Baseline and week 8|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
1263919|NCT00406640|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A total score minus baseline adjusted mean total score.|Baseline and Week 8|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Deviation|Mean
1263971|NCT00406315|Secondary|Change From Baseline in Waist and Hip Circumference at Week 16|Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||centimeter||Standard Deviation|Mean
1263972|NCT00406315|Secondary|Change From Baseline in Fasting Insulin at Week 16|Fasting insulin value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||microinternational (mciu)/milliliter(mL)||Standard Deviation|Mean
1263923|NCT00406640|Secondary|Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)|A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||percentage of patients|||Number
1263924|NCT00406640|Primary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17.|Baseline and 8 weeks|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
1263925|NCT00406393|Secondary|Time to Discharge After Transplant||Measured at Year 2|Insufficient data to report on this outcome measure||||||
1263926|NCT00406393|Secondary|Infections||Measured at Year 2|Insufficient data to report on this outcome measure||||||
1263927|NCT00406393|Secondary|Overall Survival||Measured at Year 2||||percentage of participants||95% Confidence Interval|Number
1263928|NCT00406393|Secondary|Malignant Disease Relapse|Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, MDS or CMML consistent with pre-transplant features.|Measured at Year 2||||percentage of participants||95% Confidence Interval|Number
1263929|NCT00406393|Secondary|Treatment-related Mortality||Measured at Day 100 and Year 2||||percentage of participants||95% Confidence Interval|Number
1263930|NCT00406393|Secondary|Reactivation of Cytomegalovirus (CMV) Infection||Measured at Year 2||||percentage of participants||95% Confidence Interval|Number
1263931|NCT00406393|Secondary|Thrombotic Microangiopathy (TMA) Infection|The occurrence of TMA within the first 100 days after stem cell transplantation will be recorded. The first day of onset will be used for reporting purposes.|Measured through Day 100||||percentage of participants||95% Confidence Interval|Number
1263932|NCT00406393|Secondary|Rate of Veno-occlusive Disease (VOD)|VOD will be defined as the occurrence of VOD (based on the Baltimore Criteria for the diagnosis of VOD) in conjunction with other end-organ dysfunction.|Measured through Day 100||||percentage of participants||95% Confidence Interval|Number
1263933|NCT00406393|Secondary|Mucositis Severity|Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 represents severe mucosa.|Measured at Day 21||||units on a scale||Standard Deviation|Mean
1263934|NCT00406393|Secondary|Time to Neutrophil and Platelet Engraftment|Neutrophil engraftment is defined as achieving an Absolute Neutrophil Count (ANC) > 500/mcL for three consecutive measurements on different days. Platelet engraftment is defined as a platelet count > 20,000/mcL for three consecutive measurements over three or more days.|Measured through Day 100||||days||Full Range|Median
1263935|NCT00406393|Secondary|Incidence of Acute GVHD|Cumulative incidence of acute GVHD (grade II-IV) occurring 100 days from transplantation.|Measured at Day 100||||percentage of participants||95% Confidence Interval|Number
1263936|NCT00406393|Primary|Rate of Grades II-IV Acute GVHD-free Survival|The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.|Day 114||||percentage of participants||95% Confidence Interval|Number
1263937|NCT00406367|Secondary|Patient Evaluation of Global Response (PEGR) at Final Visit|"The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4)."|Final visit (up to week 20 after injection of the Main Period)|"Intention to treat population with missing values imputed by no effect."|||Points on a scale||Standard Deviation|Mean
1263938|NCT00406367|Secondary|Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection|The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 6|Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values|||Points on a scale||Standard Deviation|Mean
1263939|NCT00406367|Secondary|Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)|"The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:~JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)~JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 6|Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values|||Points on a scale||Standard Deviation|Mean
1263973|NCT00406315|Secondary|Change From Baseline in Fasting Glucose at Week 16|Fasting glucose value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||mg/dL||Standard Deviation|Mean
1263974|NCT00406315|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16|HbAlc value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||percent||Standard Deviation|Mean
1263940|NCT00406367|Primary|Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater)|"The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:~JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)~JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 6|Intention to treat population: all participants randomized were included in the primary efficacy analysis; Last Observation Carried Forward (LOCF) imputation technique used for missing values|||Points on a scale||Standard Error|Least Squares Mean
1263941|NCT00406354|Secondary|Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period|Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event.|9 weeks|All randomized participants who received at least one dose of study drug.|||participants|||Number
1263942|NCT00406354|Secondary|Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment|Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event.|3 weeks|All randomized participants who received at least one dose of study drug.|||participants|||Number
1263943|NCT00406354|Secondary|Number of Participants Discontinuing Treatment|Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||participants|||Number
1263944|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263945|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263946|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263947|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263948|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263949|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263950|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263951|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores|The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263952|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): ODD Score|The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263953|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): ADHD Score|The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263954|NCT00406354|Secondary|Impact on Family Scale (FaBel), Total Impact Score|Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263955|NCT00406354|Secondary|Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score|ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263956|NCT00406354|Secondary|Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score|ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263957|NCT00406354|Secondary|Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity|"FBB-SSV (Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263958|NCT00406354|Secondary|Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity|"FBB-HKS (Fremdbeurteilungsbogen fur Hyperkinetische Storungen), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263959|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score|The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263960|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score|The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263961|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score|The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1292595|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population||Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1263962|NCT00406354|Primary|Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score|The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1263963|NCT00406315|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16|The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
1263964|NCT00406315|Secondary|Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16|GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
1263965|NCT00406315|Secondary|Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16|The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
1263966|NCT00406315|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16|The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
1263967|NCT00406315|Secondary|Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16|The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject’s clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).|Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
1263968|NCT00406315|Secondary|Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16|The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject’s overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
1263969|NCT00406315|Secondary|Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16|PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|Intent-to-treat population (ITT) = all enrolled subjects with baseline and at least 1 post baseline efficacy evaluation. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
1263970|NCT00406315|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16|AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.|Baseline, Week 16|Safety population.|||scores on a scale||Standard Deviation|Mean
1263979|NCT00406276|Primary|Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.|"Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started."|6 weeks|24 patients received at least 2 cycles of therapy and underwent imaging studies to assess response.|||participants|||Number
1263980|NCT00406133|Secondary|Total Costs: Direct and Indirect Costs|Investigators reported time spent with patients on CGM training and diabetes management excluding research time. Adult patients (or caregivers of children) self-reported health service utilization including routine office visits, after-hours clinic visits, emergency room visits, 911 calls, and hospitalizations. The daily cost of CGM technology was calculated based on FDA recommended frequency of sensor replacement and the expected frequency of receiver and transmitter replacement. The costs of the three devices used during the trial were averaged to arrive at a daily cost of CGM of $13.85. This daily cost was multiplied by the reported weekly use of CGM to arrive at an overall cost of CGM technology. Indirect costs: self-reported number of hours devoted to diabetes care per day, number of days missed from work or school due to diabetes, and number of days of work underperformance. Unit costs available at: http://care.diabetesjournals.org/cgi/content/full/dc09–2042/DC1 (Table 1).|26 weeks|Baseline A1c < 7.0%|||dollars||Standard Error|Mean
1263981|NCT00406133|Secondary|QALW|Quality Adjusted Life Weeks: We collected experienced utility data by eliciting time tradeoff (TTO) utilities for overall experience. Patients were asked to consider their current state of health in comparison to life in perfect health. Experienced utilities were elicited at baseline, 13 weeks, and 26 weeks. For children aged <18 years, parents served as surrogates. The total quality-adjusted life weeks (QALWs) were calculated as the area under the quality-of-life time trends under each arm.|26 weeks|Baseline A1c <7.0%|||weeks||Standard Error|Mean
1263982|NCT00406133|Other Pre-specified|26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263983|NCT00406133|Other Pre-specified|Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263984|NCT00406133|Other Pre-specified|Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263985|NCT00406133|Post-Hoc|26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)|A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263986|NCT00406133|Other Pre-specified|26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)|A 26-week A1c level <7.0% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263987|NCT00406133|Other Pre-specified|Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)|A relative increase by in A1c level >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263988|NCT00406133|Other Pre-specified|Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)|A relative decrease A1c level by >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263989|NCT00406133|Secondary|Cost-effectiveness of CGM.|Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group|26 weeks|Baseline A1c<7%.|||dollars per QALY|||Number
1263990|NCT00406133|Secondary|Quality of Life|Hypoglycemia Fear Survey Total Score Average score of all items giving equal weight to each item. Scale 0-100 with higher score denoting more fear or more likely to avoid low blood glucose.|26 weeks|Participants >= 18 years of age. Pools participants with baseline HbA1c <7.0% and >=7.0%.|||units on a scale||Standard Deviation|Mean
1263991|NCT00406133|Secondary|Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)|Glucose variability was assessed by computing the absolute rate of change.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||mg/dl/min||Inter-Quartile Range|Median
1263992|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
1263993|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort|Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
1292596|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population|Measured by DXA.|Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1263995|NCT00406133|Other Pre-specified|Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)|A relative decrease in A1c level >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
1263996|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
1263997|NCT00406133|Secondary|Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
1263998|NCT00406133|Secondary|Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort)|The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c <7.0% cohort), as determined by a central laboratory.|Baseline and 26 weeks|Analysis was performed according to Intention to Treat principle. Results based on non-missing data were reported. Imputation for missing data using Rubin's method did not alter the results (data not shown).|||Percent||Standard Deviation|Mean
1263999|NCT00406133|Secondary|Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)|Glucose variability was assessed by computing the absolute rate of change.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||Mean mg/dl/minute||Standard Deviation|Mean
1264000|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
1264001|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
1264002|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort|Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
1264003|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
1264004|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
1264005|NCT00406133|Secondary|Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c >=7.0% cohort|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||subjects with event|||Number
1264006|NCT00406133|Primary|Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)|The primary outcome was the change in the time per day with glucose values <=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
1264007|NCT00406133|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)|The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c >=7.0% cohort).|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||Percent||Standard Deviation|Mean
1264008|NCT00406107|Secondary|Change in Macular Volume on OCT From Baseline to Week 54||54 Weeks||||mm cubed||Standard Deviation|Mean
1264009|NCT00406107|Secondary|Change in Central Subfield Thickness on OCT From Baseline to Week 54||54 Weeks||||microns||Standard Deviation|Mean
1264010|NCT00406107|Secondary|Safety Parameters|Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug.|54 Weeks||||percentage of participants|||Number
1264011|NCT00406107|Secondary|Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield||54 Weeks|Fifteen patients were enrolled in the pegaptanib 0.3 mg dose group and 5 patients were enrolled in the 1.0 mg dose group.|||microns||Standard Deviation|Mean
1264012|NCT00406107|Primary|Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks||54 Weeks||||ETDRS letters||Standard Deviation|Mean
1264013|NCT00406029|Secondary|Change From Baseline in UPDRS Part 4|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 4 subscale assesses complications of therapy over the past week for a total of eleven question items. The first three questions and question 8 are rated from 0 (best) to 4 (worst), and the remaining seven questions are simple no (0) / yes (1) questions. The total subscale score ranges from 0 to 23. Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline date (UPDRS Part 4) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
1264014|NCT00406029|Secondary|Change From Baseline in UPDRS Part 3 (2 Hours Post-dose)|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 3 subscale assesses motor function across 14 categories for 27 items. Scores for each item range from 0 (best) to 4 (worst) with a total range of 0-108. Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled standard deviation were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 3) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
1264015|NCT00406029|Secondary|Change From Baseline in UPDRS Part 3 (1 Hour Post-dose)|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 3 subscale assesses motor function across 14 categories for 27 items. Scores for each item range from 0 (best) to 4 (worst) with a total range of 0-108. Assessments were obtained at baseline (predose Day 1) and 1 hour postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 1 hour postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 3) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
1264016|NCT00406029|Secondary|Change From Baseline in UPDRS Part 2|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. Part 2 assesses daily living (13 items scored from 0 [best] to 4 [worst]; total range 0-52). Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 2) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
1264017|NCT00406029|Secondary|Change From Baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) Part 1|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. Part 1 assesses mentation (4 items scored from 0 [best] to 4 [worst]; total range 0-16). Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 1) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
1264018|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 12|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 12) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 12 would be reported as BL >2 to WK12 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 12|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
1264019|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 10|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 10) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 10 would be reported as BL >2 to WK10 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 10|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
1264020|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 8|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 8) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 8 would be reported as BL >2 to WK8 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 8|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
1264021|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 6|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 6) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 6 would be reported as BL >2 to WK6 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 6|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
1264022|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 4|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 4) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 4 would be reported as BL >2 to WK4 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 4|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
1264023|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 2|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 2) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 2 would be reported as BL >2 to WK2 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 2|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
1264024|NCT00406029|Secondary|Change From Baseline in Total Sleep Time|Hours spent in the sleep state were recorded using a daily diary at least 3 full days before scheduled visit. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A positive change from baseline means more time asleep and a negative change means less time asleep.|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (total sleep time) for the assessment week was used for analysis.|||hours/day||Standard Deviation|Least Squares Mean
1264025|NCT00406029|Secondary|Change From Baseline in Absolute Duration of Dyskinesias|Dyskinesias refers to maintenance therapy side effects of chorea, dystonia, or in combination (that occur in the ON time). Hours spent with dyskinesias (troublesome and not troublesome) were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A negative change from baseline signifies less time spent with dyskinesia.|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with troublesome and not troblesome dyskinesias) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
1264032|NCT00405964|Secondary|Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment|AM/PM PRIOR (the participant’s status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Days 1-85|All randomized participants|||units on a scale||Standard Error|Least Squares Mean
1264124|NCT00405548|Secondary|Change in Glomerular Filtration Rate (GFR) in Response to Saline Load|Renal or kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/ml/1.73 m^2 of body surface area is considered to be impaired kidney function.|Baseline, 12 weeks||||ml/min/1.73 m^2 body surface area||Standard Deviation|Mean
1264026|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (Without Troublesome Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Troublesome dyskinesias refers to maint. therapy side effects of chorea, dystonia, or in combination that impair function. Hours spent in the on state without troubles. dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A (+) change from baseline signifies more time spent in the on state (without troubles. dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state without troublesome dyskinesias) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
1264027|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (With Troublesome Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Troublesome dyskinesias refers to maintenance therapy side effects of chorea, dystonia, or in combination that impair function. Hours spent in the on state with troublesome dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A (+) change from baseline signifies more time spent in the on state (troublesome dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with troublesome dyskinesias) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
1264028|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (no Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Dyskinesias refers to maintenance therapy (e.g., L-dopa) side effects of chorea, dystonia, or in combination. Hours spent in the on state with no dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained from an ANCOVA model with effect for treatment & baseline covariate. A (+) change from baseline signifies more time spent in the on state (no dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with no dyskinesias) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
1264029|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State"|"On time refers to periods of adequate control of Parkinson disease symptoms (symptoms better or absent). Hours spent in the on state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. A positive (+) change from baseline signifies more time spent in the on state."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
1264030|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the Off State at Each Visit"|"Off time refers to periods of inadequate control of Parkinson disease symptoms (worsening or presence of symptoms). Hours spent in the off state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with treatment effect and baseline covariate. A negative change from baseline signifies less time spent in the off state."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the off state) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
1264031|NCT00406029|Primary|"Change From Baseline to Endpoint of 12 Weeks in the 3-day Average of Awake Time Per Day Spent in the Off State"|"Off time refers to periods of inadequate control of Parkinson disease symptoms (worsening or presence of symptoms). For baseline and the 12 weeks treatment period, hours spent in the off state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. Change from baseline in least squares (LS) means and pooled standard deviation (SD) were obtained from an analysis of covariance (ANCOVA) model with effect for treatment and baseline covariate. A negative change from baseline signifies less time spent in the off state."|Baseline (Week -1) and up to 12 weeks|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the off state) was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
1264033|NCT00405964|Secondary|Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment|The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Day 29|All randomized participants|||units on a scale||Standard Error|Least Squares Mean
1264034|NCT00405964|Primary|Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment|AM/PM PRIOR (the participant’s status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Days 1-29|All randomized participants|||units on a scale||Standard Error|Least Squares Mean
1264035|NCT00405938|Secondary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months|||||||
1264036|NCT00405938|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.|18 months||||months||95% Confidence Interval|Median
1264037|NCT00405912|Primary|Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco|"Point prevalence tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question Have you used any type of tobacco,even a puff, in the past 7 days? and (b) Expired Carbon Monoxide equal or less then 8 parts per million."|12 weeks following start of medication||||participants|||Number
1264038|NCT00405912|Secondary|Number of Subjects With Prolonged Abstinence From Tobacco|tobacco abstience during the 12-week course of SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day compared to placebo at six months.|24 weeks after the start of medication||||participants|||Number
1264039|NCT00405821|Secondary|Virologic and Immunologic Responses to ART in Those Who Progress to CD+4 Less Than 250cells/mL||6 months and 12 moths post ART initiation|||||||
1264040|NCT00405821|Secondary|Adherence to Acyclovir||2 years|||||||
1264041|NCT00405821|Secondary|Toxicity of Acyclovir||2 years|||||||
1264042|NCT00405821|Secondary|HIV-1 Viral Load Difference Between Arms|We measured mean annual rate of change in log10 viral load (copies/mL) for each group. We assessed difference in annual rate of change in log10 viral load (copies/mL) between groups.|baseline, 6 months, 12 months, 18 months, 24 months|We measured viral load at baseline and at 6 monthly follow-up visits during 24 months of follow-up for all subjects randomized on this study.|||log10 (copies/mL)||95% Confidence Interval|Mean
1264043|NCT00405821|Secondary|Difference in Number of Episodes of Genital Ulcer Disease Between Arms|We calculated incidence rate for each treatment arm for episodes of genital ulcer disease, and incidence rate ratio.|2 years|We conducted monthly clinical assessment for GUD on all randomized subjects during their entire follow-up period on this trial. The number of episodes of GUD is shown below.|||episodes|||Number
1264044|NCT00405821|Primary|Progression to AIDS (CD4+ Less Than 250 Cells/Microliter or World Health Org Stage IV dx, Excluding Esophageal Candidiasis)|Evaluate the effect of acyclovir prophylaxis vs placebo among HIV-1/HSV-2 co-infected individuals on the progression to AIDS (CD4+ less than 250 cells/microliter or World Health Org stage IV disease, excluding esophageal candidiasis)|2 years|Intention to treat analysis of all subjects randomized on the trial meeting the primary endpoint|||participants|||Number
1264045|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264046|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264047|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264048|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264049|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264050|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264051|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264052|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264053|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264054|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264055|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264056|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264057|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264058|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1292597|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population|Measured by DXA.|Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1264059|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264060|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264061|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264062|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264063|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale|Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
1264064|NCT00405756|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period|Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption.|Up to 169 weeks (Double-blind therapy period plus 4 weeks)|Safety population|||participants|||Number
1264065|NCT00405756|Secondary|Kaplan Meier Estimates for Time to Next Antimyeloma Therapy|Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.|Up to 168 weeks|Intent to treat population|||weeks||95% Confidence Interval|Median
1264066|NCT00405756|Secondary|Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|Up to 149 weeks|Population: Participants who achieved a partial response (PR) or complete response (CR).|||weeks||95% Confidence Interval|Median
1264067|NCT00405756|Secondary|Time to First Response|Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria.|Up to 66 weeks|Participants who had a partial response (PR) or complete response (CR)|||weeks||Standard Deviation|Mean
1264068|NCT00405756|Secondary|Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period|Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).|Up to 165 weeks|Intent to treat population|||participants|||Number
1264125|NCT00405548|Secondary|Change in Urinary Flow in Response to Saline Load|Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute.|Baseline, 12 weeks||||ml/minute||Standard Deviation|Mean
1292598|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population|Measured by DXA.|Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1264069|NCT00405756|Secondary|Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 165 weeks|Intent to treat population|||weeks||95% Confidence Interval|Median
1264070|NCT00405756|Secondary|Kaplan Meier Estimates of Overall Survival (OS)|Data as of 11 May 2010 cutoff. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who were lost to follow-up prior to the end of the trial, or who were withdrawn from the trial, were censored at the time of last contact. Participants who were still being treated were censored at the last available date available, or clinical cut-off date, if it was earlier.|up to 177 weeks|Intent to treat population|||weeks||95% Confidence Interval|Median
1264071|NCT00405756|Secondary|Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause.~PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|Approximately week 37 (start of cycle 10) to week 165|Intent to treat (ITT) population of participants in Arms MPR+R and MPR+p who entered maintenance within the Double-blind Treatment Period|||weeks||95% Confidence Interval|Median
1264072|NCT00405756|Primary|Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 165 weeks|Intent-to-treat population|||weeks||95% Confidence Interval|Median
1264073|NCT00405704|Secondary|Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen||2 years|The analysis population is restricted to the 38 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 69 subjects in the placebo group who had a recurrent UTI with an organism for which sensitivity to TMP-SMZ was assessed.|||participants|||Number
1264074|NCT00405704|Secondary|Recurrent Febrile or Symptomatic UTI With Resistant E. Coli||2 years|The analysis population is restricted to the 30 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 57 subjects in the placebo group who had a recurrent UTI with E. coli for which sensitivity to TMP-SMZ was assessed.|||participants|||Number
1264075|NCT00405704|Secondary|Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)||2 years|The analysis population excluded 99 subjects in the trimethoprim-sulfamethoxazole group and 95 subjects in the placebo group who did not have stool analyzed at the outcome visit.|||participants|||Number
1264076|NCT00405704|Secondary|Treatment Failure Composite|Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.|2 years||||participants|||Number
1264077|NCT00405704|Secondary|New Renal Scarring on Outcome Scan|New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 82 subjects in the trimethoprim-sulfamethoxazole group and 78 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.|||participants|||Number
1264078|NCT00405704|Secondary|Severe Renal Scarring on Outcome Scan|Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.|||participants|||Number
1264079|NCT00405704|Secondary|Outcome Renal Scarring|Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.|||participants|||Number
1264080|NCT00405704|Primary|Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up||2 years||||participants|||Number
1264081|NCT00405652|Secondary|The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes|The number of participants with subclinical rejection episodes as defined by a steroid-sensitive, clinically relevant increase of AST, ALT, gamma-GT, AP or bilirubin (i.e., elevation of one or more of these enzymes that was considered clinically relevant and showed resolution upon treatment with a slight increase of steroid dosage).|12-20 weeks|Intent to Treat|||Participants|||Number
1264126|NCT00405509|Secondary|Severity of Symptom Score - SNEEZING|Sneezing symptoms were rated by participants once a day for six days and on Day 30, symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on Day 30||||units on a scale||Standard Deviation|Mean
1264082|NCT00405652|Primary|Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life|Change in Gastrointestinal symptom rating scale (GSRS) total score from baseline visit to follow-up visit 6-8 weeks after treatment. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores.|Baseline, End of Study (6-8 weeks)|Intent to Treat Population (No last Observation Carried Forward). The number of participants completing the GSRS at Baseline = 31 and at the End of Study= 29.|||Scores on a Scale||Standard Deviation|Mean
1264083|NCT00405639|Primary|Change in Urinary Sodium Excretion in Response to Saline Load||baseline, 12 weeks||||mEq/min||Standard Deviation|Mean
1264084|NCT00405639|Secondary|Change in Left Ventricular Mass Index|Left ventricular mass index (LVMI) is a surrogate of left ventricular hypertrophy and a predictor of cardiac morbidity and mortality in adults with hypertension. LVMI was measured with echocardiography, indexed to body surface area estimated by left ventricular (LV) cavity dimension and wall thickness at end-diastole.|baseline, 12 weeks||||g/m^2||Standard Deviation|Mean
1264085|NCT00405639|Secondary|Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) in Response to Saline Load|Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|baseline, 12 weeks||||ml/min/1.73 m^2||Standard Deviation|Mean
1264086|NCT00405639|Secondary|Change in Urine Flow in Response to Saline Load||baseline, 12 weeks||||ml/min||Standard Deviation|Mean
1264087|NCT00405587|Secondary|Tumor Levels of Phosphorylated Extracellular Signal-Regulated Kinapse (ERK), Cyclin D1, and Ki-67|The immunohisto-chemical analyses of the expression of phosphorylated ERK, cyclin D1, and Ki-67 in tumor-biopsy specimens was performed using hematoxylin and eosin staining.|BL and Day 15|||||||
1264088|NCT00405587|Secondary|Cmax of RO5185426 – Food Effect||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1 and 15, pre-morning dose on Day 2, Day 8, and Day 16|||||||
1264089|NCT00405587|Secondary|Decrease in Tumor Uptake of 18F-fluorodeoxyglucose (FDG)|Tumor uptake of FDG was assessed by means of positron-emission tomography (PET)|BL and Day 15|||||||
1264090|NCT00405587|Secondary|Mean Dose-Normalized Steady-State Cmax of RO5185426 80 mg and 120 mg Capsules - Dose Escalation: MBP Formulation and Extension: BRAFV600E- Positive Melanoma||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1 and 15, pre-morning dose on Day 2 and Day 8, and Day 16|PK Population: The analysis was planned only for those participants who received 80 or 120 mg dose of RO5185426 up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||ug/mL||Standard Deviation|Mean
1264091|NCT00405587|Secondary|Mean Dose-Normalized Steady-State AUC of RO5185426 80 mg and 120 mg Capsules - Dose Escalation: MBP Formulation and Extension: BRAFV600E- Positive Melanoma|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|The analysis was planned only for those participants who received 80 or 120 mg dose of RO5185426 up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
1264092|NCT00405587|Secondary|Time to CR or PR Using RECIST v1.0 – Extension: BRAFV600E- Positive Melanoma|Time to CR or PR was defined as the interval between the date of the first treatment to the date of the first documentation of confirmed CR or PR whichever occurred first, and not the date of confirmation at the subsequent tumor assessment. Time to response = Date of first response – initial dose date + 1.|Screening, BL, and up to 168 days|Modified ITT population: Participants with a confirmed CR or PR with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered.|||days||Full Range|Median
1264093|NCT00405587|Secondary|Overall Survival (OS) – Extension: BRAFV600E- Positive Melanoma|OS was the period of time measured from the date of initiation of therapy to the date of the death. In the event of no death prior to study termination or analysis data cutoff, OS was censored at the last known date that the patient was alive as documented on the follow-up case report form. If this date was not available, then the last known alive date from the database was used.|Screening, BL, until PD, or end of efficacy follow-up, up to 444 days|Modified ITT Population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Twenty participants were censored for analysis.|||days||95% Confidence Interval|Median
1264094|NCT00405587|Secondary|Percentage of Participants Who Died – Extension: BRAFV600E- Positive Melanoma||Screening, BL, until PD, or end of efficacy follow-up, up to 444 days|Modified ITT Population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered.|||percentage of participants|||Number
1264111|NCT00405587|Primary|Cmax of RO5185426 on Day 1 – Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||micrograms per milliliter||Standard Deviation|Mean
1264127|NCT00405509|Secondary|Severity of Symptom Score - NASAL CONGESTION|nasal congestion symptoms were rated by the participant once a day for six days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on day 30||||units on a scale||Standard Deviation|Mean
1264095|NCT00405587|Secondary|PFS Using RECIST v1.0 – Extension BRAFV600E Positive Melanoma|PFS was the period of time measured from the date of initiation of therapy to the date of the appearance of new metastatic lesions, objective tumor progression, or death if before progression. PD was at least a 20% increase in the sum of longest diameters of TLs taking as reference the smallest sum of longest diameters recorded since the baseline measurements, or the appearance of one or more new lesion(s). For Non-TLs, disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs. In the event of no disease progression or documented death prior to study termination, analysis cutoff, or start of confounding anticancer therapy, PFS was censored at the date of the last evaluable tumor assessment.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 421 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Eight participants were censored for analysis.|||days||95% Confidence Interval|Median
1264096|NCT00405587|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Using RECIST v 1.0 - Melanoma Extension Cohort|PFS was the period of time measured from the date of initiation of therapy to the date of the appearance of new metastatic lesions, objective tumor progression, or death if before progression. PD was defined according to the RECIST criteria (v 1.0) as increase by at least 20% in the sum of the longest diameters of each TL, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. For Non-TLs, PD was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.|Month 1, 3, 4, 6, 9, and Last event (350) days|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Eight participants were censored for analysis.|||percentage of participants|||Number
1264097|NCT00405587|Secondary|Duration of CR or PR Using RECIST v 1.0 – Extension BRAFV600E- Positive Melanoma|Duration of response for participants with confirmed CR or PR was the period of time measured between the date that the criteria for objective CR or PR (whichever status was recorded first) was met, and the first date that recurrent or PD was objectively documented (or death if before progression). PD was at least a 20% increase in the sum of longest diameters of TLs taking as reference the smallest sum of longest diameters recorded since the baseline measurements, or the appearance of one or more new lesion(s). In the event of no disease progression or documented death prior to study termination, analysis cutoff, or initiation of confounding anticancer therapy, duration of response was censored at the date of the last evaluable tumor assessment.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: Participants with confirmed CR or PR with a measurable disease at BL, and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Seven participants were censored for analysis.|||days||95% Confidence Interval|Median
1264098|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 – Dose Escalation: MBP Formulation|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.|||percentage of participants||95% Confidence Interval|Number
1264099|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 – Dose Escalation: Original Formulation|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.|||percentage of participants||95% Confidence Interval|Number
1264100|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 – Extension: BRAFV600E- Positive CRC|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Confirmed responses were those which were confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.|||percentage of participants||95% Confidence Interval|Number
1264123|NCT00405548|Primary|Change in Urinary Sodium Excretion in Response to Saline Load|Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).|Baseline, 12 weeks||||mEq/minute||Standard Deviation|Mean
1264101|NCT00405587|Primary|Percentage of Participants With a Confirmed and an Unconfirmed Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST Version (v) 1.0 – Extension: BRAFV600E- Positive Melanoma|BOR of confirmed /unconfirmed (total) response was defined as CR or PR recorded from baseline until disease progression/recurrence according to Response Evaluation Criteria In Solid Tumors (RECIST) v 1.0 criteria. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30 percent (%) decrease in the sum of longest diameters of the TLs, taking as a reference the baseline (BL) sum of longest diameters. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Confirmed responses were those which were confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.|||percentage of participants||95% Confidence Interval|Number
1264102|NCT00405587|Primary|Tmax of RO5185426 on Day 15 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
1264103|NCT00405587|Primary|Tmax of RO5185426 on Day 1 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
1264104|NCT00405587|Primary|Cmax of RO5185426 on Day 15 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15 and pre-morning dose on Day 16|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||microgram/milliliter||Standard Deviation|Mean
1264105|NCT00405587|Primary|Cmax of RO5185426 on Day 1 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||microgram/milliliter||Standard Deviation|Mean
1264106|NCT00405587|Primary|AUC of RO5185426 on Day 15 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
1264107|NCT00405587|Primary|AUC of RO5185426 on Day 1 – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||mcg*hr/mL||Standard Deviation|Mean
1264108|NCT00405587|Primary|Tmax of RO5185426 on Day 15 – Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
1264109|NCT00405587|Primary|Tmax of RO5185426 on Day 1 – Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
1264110|NCT00405587|Primary|Cmax of RO5185426 on Day 15 – Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||micrograms per milliliter||Standard Deviation|Mean
1265636|NCT00394654|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1264112|NCT00405587|Primary|Mean RO5185426 Accumulation Ratios – Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1.|Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ratio||Standard Deviation|Mean
1264113|NCT00405587|Primary|Mean RO5185426 Accumulation Ratios – Dose Escalation: MBP Formulation|Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1.|Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ratio||Standard Deviation|Mean
1264114|NCT00405587|Primary|AUC of RO5185426 on Day 15 – Dose Escalation: MBP Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||mcg*hr/mL||Standard Deviation|Mean
1264115|NCT00405587|Primary|AUC of RO5185426 on Day 1 – Dose Escalation: MBP Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
1264116|NCT00405587|Primary|Time to Peak Concentration (Tmax) of RO5185426 on Day 15 – Dose Escalation: Original Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, pre-morning dose on Day 16|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
1264117|NCT00405587|Primary|Time to Peak Concentration (Tmax) of RO5185426 on Day 1 – Dose Escalation: Original Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
1264118|NCT00405587|Primary|Peak Concentration (Cmax) of RO5185426 on Day 15 – Dose Escalation: Original Formulation||Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 15, pre-morning dose on Day 16|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||Micrograms per milliliter||Standard Deviation|Mean
1264119|NCT00405587|Primary|Peak Concentration (Cmax) of RO5185426 on Day 1 – Dose Escalation: Original Formulation||Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||Micrograms per milliliter||Standard Deviation|Mean
1264120|NCT00405587|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 – Dose Escalation: Original Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
1264121|NCT00405587|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 – Dose Escalation: Original Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
1264122|NCT00405548|Secondary|Left Ventricular (LV) Filling Pressure|LV diastolic function as measured by Doppler echocardiography. E/e' is the ratio of the mitral inflow velocity (E) to the mitral annulus tissue Doppler velocity (e'). A decrease in the ratio indicates a lower filling pressure and improved LV diastolic function.|Baseline, 12 weeks||||E/e'||Standard Deviation|Mean
1264131|NCT00405392|Secondary|Mean Percent Change of Serum C-terminal Telopeptide (CTx) From Baseline to Visit 3 for Once-monthly Dosing of Ibandronate & Once-weekly Dosing of Risedronate|The difference of change in serum CTX from basal value between the two sequences was tested using ANCOVA at 95% confidence interval at 3 months (Visit 3) after the administration. Analysis was done with PP population. Baseline was value at Week 0, Change from baseline was calculated by subtracting Baseline value from value at specified time point.|Baseline (Week 0) and Visit 3 (Week 12)|Per protocol population comprised of any participant, who didn’t violate the study protocol, filled the preference questionnaire at the completion of the study, finished assessment of bone turnover marker, and completed journal of GI symptoms. Only the participants available at the time of assessment were analyzed.|||Percent change||Standard Deviation|Mean
1264132|NCT00405392|Secondary|Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration|Participant’s preference for convenient treatment was compared between monthly ibandronate and weekly risedronate. Analysis population was mITT. Preference for convenient treatment was calculated as percentage. Percentage of participants who think once-monthly ibandronate dosing is more convenient over once-weekly risedronate dosing were presented. Those participants who answered the two treatments equally convenient were excluded while reporting.|Visit 4 (Week 24)|mITT Population. Percentages do not sum to 100 because some participants did not express a preference.|||Percentage of particiants|||Number
1264133|NCT00405392|Primary|Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate|Preference of monthly ibandronate and weekly risedronate was compared. Modified-intention-to-treat (mITT) population was used for analysis. Any participant randomly assigned, received the study drug, and participants were asked to fill the preference questionnaire on completion of study. Preference was calculated as percentage. Data for percentage of participants with preference to once-monthly dosing of ibandronate to the once-weekly dosing of risedronate was presented.|Visit 4 (Week 24)|mITT population was comprised of any participant, who was randomly assigned, received the study drug once more at each phase, filled out the preference questionnaire at the completion of the study. Percentages do not sum to 100 because some participants did not express a preference.|||Percentage of participants|||Number
1264134|NCT00405288|Post-Hoc|Other Neonatal Health Concerns||neonatal period||||participants|||Number
1264135|NCT00405288|Post-Hoc|Skin Conditions in Neonatal Period||neonatal period||||participants|||Number
1264136|NCT00405288|Post-Hoc|Neonatal Health Concerns-infections|Infections occuring in the neonatal period|neonatal period||||participants|||Number
1264137|NCT00405288|Post-Hoc|Respiratory Neonatal Health Concerns||neonatal period||||participants|||Number
1264138|NCT00405288|Post-Hoc|Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth|Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth|neonatal period||||participants|||Number
1264139|NCT00405288|Secondary|Neonatal Health|Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth|at birth||||participants|||Number
1264140|NCT00405288|Secondary|Low Birth Weight at Birth|Low birth weight (birth weights <2500 grams)|at birth|Per protocol, the estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight (primary outcome) for a power of 80% and alpha of 5% was used.|||participants|||Number
1264141|NCT00405288|Secondary|Fetal Distress|Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid|at birth||||participants|||Number
1264142|NCT00405288|Secondary|Prematurity|birth at <37 gestational weeks|at birth||||participants|||Number
1264143|NCT00405288|Secondary|Mode of Delivery|Method of delivery for both groups: vaginal or caesarean section|at birth||||participants|||Number
1264144|NCT00405288|Secondary|Gestational Age at Delivery|Fetal gestational age at delivery|until delivery||||gestational weeks||Standard Deviation|Mean
1264145|NCT00405288|Primary|Birth-weight|Weight of the baby measured in grams at time of birth.|until delivery|Estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight at a power of 80% and alpha of 5%. Seven pairs of twin pregnancies were excluded from the comparison of birth weight.|||grams||Standard Deviation|Mean
1264146|NCT00405275|Primary|Mean 48-week Change in DAS28|"Average difference between 48-week and Baseline DAS28.~The Disease Activity Score for 28 Joints (DAS28) is a well-validated composite outcome measure ranging from 2-10 (higher scores indicating more disease) that incorporates a tender and swollen joint count of 28 joints, a laboratory measure of systemic inflammation (ESR) and a patient-reported general assessment of health on a visual analog scale (ranging from 0-10cm) all into one measure.~Low disease activity is defined as DAS28 ≤ 3.2 units."|48 weeks after baseline assessment|Intention to treat analysis was performed on participants with Week 48 DAS28 data.|||units on a scale||Standard Deviation|Mean
1264147|NCT00405067|Secondary|Percent Change in Body Weight at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1264148|NCT00405067|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1264149|NCT00405067|Secondary|Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1264150|NCT00405067|Secondary|Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline||baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1264151|NCT00405067|Secondary|Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1264152|NCT00405067|Secondary|Percent Change in HDL-C at 12 Weeks Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1264153|NCT00405067|Secondary|Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1264154|NCT00405067|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline.||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
1264157|NCT00404924|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF)|Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days. Where assessment is by a selection of questions from the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit||||weeks||Inter-Quartile Range|Median
1264158|NCT00404924|Primary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||Months||95% Confidence Interval|Median
1264159|NCT00404924|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression||||Weeks||95% Confidence Interval|Median
1264160|NCT00404924|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression||||Participants|||Number
1264161|NCT00404924|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 8 weeks, progressive disease (PD) or NE."|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression.||||Participants|||Number
1264162|NCT00404924|Secondary|Progression-Free Survival (PFS)|Median time (in months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression||||month||95% Confidence Interval|Median
1264163|NCT00404820|Primary|Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population|The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Per Protocol population: All intent-to-treat patients who did not show major deviations from the protocol procedures that may have had an impact on the study outcome.|||ng/ml||Standard Deviation|Mean
1264164|NCT00404820|Secondary|Therapy Preference at End of Study (Month 12)|Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.|Month 12|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||Participants|||Number
1264165|NCT00404820|Secondary|Change in Body Height From Baseline to Month 12|Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||cm||Standard Deviation|Mean
1264166|NCT00404820|Secondary|Number of Patients With a Clinical Fracture From Baseline to Month 12|A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||Participants|||Number
1264167|NCT00404820|Secondary|Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12|The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||Units on a scale||Standard Deviation|Mean
1264168|NCT00404820|Secondary|Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12|The level of bone activity as measured by P1NP over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||ng/ml||Standard Deviation|Mean
1264169|NCT00404820|Primary|Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population|The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||ng/ml||Standard Deviation|Mean
1264170|NCT00404768|Secondary|Percentage Reduction From Baseline in Number of Uterine Contractions [>30 Sec] Per Hour Within First 6 Hours of Therapy in Part C|For uterine contraction assessment, an external tocodynamometer was fastened around the participant’s abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose. Baseline was Day 0. Reduction from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percentage reduction from Baseline in number of uterine contractions [>30 sec] per hour within first 6 hours of therapy are presented.|First 6 hours of therapy|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1264171|NCT00404768|Secondary|Number of Participants Who Remained Undelivered Without Rescue Tocolytic Therapy After 48 Hours in Part C|Tocolytics are medications used to suppress premature labor. They are given when delivery would result in premature birth. Number of participants who remained undelivered without rescue tocolytic therapy after 48 hours are presented.|48 hours post-dose|Pharmacodynamic Population.|||Participants|||Count of Participants
1264172|NCT00404768|Secondary|Neonatal Length Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C|Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (Week 12). Mean neonatal length is presented.|At Birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Deviation|Mean
1264173|NCT00404768|Secondary|Neonatal Head Circumference Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C|Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented.|At Birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Centimeteres||Standard Deviation|Mean
1264174|NCT00404768|Secondary|Neonatal Weight Gain Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C|Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented.|At birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Grams||Standard Deviation|Mean
1264175|NCT00404768|Secondary|Neonatal Apgar Scores (at Birth) Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C|APGAR scores range from 0 to 2 for each condition (color, reflex response, muscle tone, respiration and heart rate) with a maximum final total score of 10. For heart rate: 0=no heart rate, 1=<100 bpm (baby not very responsive), 2=>100 bpm (baby vigorous); for respiration: 0=no breathing, 1= weak cry, 2=good, strong cry; for muscle tone: 0=limp, 1=some flexing of arms and legs, 2=active motion; for reflex response: 0=no response, grimace during stimulation, 2=grimace and cough or sneeze during stimulation; for color: 0=blue/pale, 1=good body color but blue hands and feet, 3=completely pink or good color. APGAR total score is the sum of sub-scores ranging from 0 to 10, where lower score indicates worst condition and higher score indicates best condition.|1 minute and 5 minute after birth at 4 to 12 weeks post adjusted gestational age|Pharmacodynamic Population.|||Scores on a scale||Standard Deviation|Mean
1264176|NCT00404768|Secondary|Derived Plasma GSK221149 Pharmacokinetic Parameters- Maximum Plasma Concentration (Cmax)|Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.|Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion|Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1264177|NCT00404768|Secondary|Derived Plasma GSK221149 Pharmacokinetic Parameters- Observed Elimination Half-life (T-half) and Time to Maximum Observed Drug Concentration (T-max)|Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.|Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion|Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters|||Hours||Standard Deviation|Mean
1264178|NCT00404768|Secondary|Derived Plasma GSK221149 Pharmacokinetic Parameters- Area Under Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) and Area Under Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC [0 to Last])|Blood samples (approximately 2mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.|Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion|Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters.|||Nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1264179|NCT00404768|Secondary|Neonatal Length Measured at 4-6 Weeks of Age in Part A and B|Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (approximately 4 to 6 weeks of age). Mean Neonatal length is presented.|At birth and follow-up (approximately 4 to 6 weeks of age)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Deviation|Mean
1264180|NCT00404768|Secondary|Neonatal Head Circumference in Part A and B|Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented.|At Birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Deviation|Mean
1264181|NCT00404768|Secondary|Neonatal Weight Gain in Part A and B|Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented.|At birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Grams||Standard Deviation|Mean
1264182|NCT00404768|Secondary|Neonatal Apgar Scores in Part A and B|APGAR scores range from 0 to 2 for each condition (color, reflex response, muscle tone, respiration and heart rate) with a maximum final total score of 10. For heart rate: 0=no heart rate, 1=<100 bpm (baby not very responsive), 2=>100 bpm (baby vigorous); for respiration: 0=no breathing, 1= weak cry, 2=good, strong cry; for muscle tone: 0=limp, 1=some flexing of arms and legs, 2=active motion; for reflex response: 0=no response, grimace during stimulation, 2=grimace and cough or sneeze during stimulation; for color: 0=blue/pale, 1=good body color but blue hands and feet, 3=completely pink or good color. APGAR total score is the sum of sub-scores ranging from 0 to 10, where lower score indicates worst condition and higher score indicates best condition.|1 minute and 5 minutes after birth|Pharmacodynamic Population.|||Scores on a Scale||Standard Deviation|Mean
1264183|NCT00404768|Secondary|Number of Participants With Preterm Births in Part C|Preterm is defined as babies born alive before 37 weeks of pregnancy are completed. There are sub-categories of preterm birth, based on gestational age: extremely preterm (<28 weeks) very preterm (28 to <32 weeks). Number of participants with preterm births are presented.|Up to 48 hours post-dose|Pharmacodynamic Population.|||Participants|||Count of Participants
1264184|NCT00404768|Primary|Number of Participants Achieving Uterine Quiescence|Uterine quiescence was defined as 4 contractions per/hour or less with no cervical change within the first 6 hours of therapy. Number of participants (from part A,B,C) achieving uterine Quiescence are presented.|Up to 48 hours post-dose|Pharmacodynamic Population.|||Participants|||Count of Participants
1264185|NCT00404768|Primary|Fetal Heart Rate Monitoring up to 48 Hours|Fetal heart rate monitoring was incorporated to assess fetal tolerability. Fetal heart rate was monitored continuously at 2, 4, 6, 8, 12, 18, 24, 36 and up to 48 hours post-therapy. Mean fetal heart rate is presented. Data for only key-time points values have been presented.|Up to 48 hours post-dose|Pharmacodynamic Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Beats per minute||Standard Deviation|Mean
1264186|NCT00404768|Primary|Number of Participants With 50% Reduction in Uterine Contractions Per Hour in Part A and B|For uterine contraction assessment, an external tocodynamometer was fastened around the participant’s abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose.The number of participants that achieve a reduction of at least 50% in uterine contractions with no cervical change within 6 hours and to maintain that reduction until 12 hours of therapy has been presented.|Up to 48 hours post-dose|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1264187|NCT00404768|Primary|Assessment of Amniotic Fluid Index (AFI)|AFI is a quantitative estimate of amniotic fluid and an indicator of fetal well-being. AFI is the score (expressed in centimetes) given to the amount of amniotic fluid seen on ultrasonography of a pregnant uterus. An AFI between 8 to 18 is considered normal. An AFI < 5 to 6 is considered as oligohydramnios characterized by deficiency of amniotic fluid. An AFI > 18 to 24 is considered as polyhydramnios characterized by excess of amniotic fluid in the amniotic sac.|Up to 48 hours-post dose|Pharmacodynamic Population which comprised of all participants who provided pharmacodynamic data. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Score||Standard Deviation|Mean
1264188|NCT00404768|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.|Up to Follow-up (Week 12)|Safety Population.|||Participants|||Count of Participants
1264189|NCT00404768|Primary|Number of Participants With Clinical Chemistry and Hematology Parameter Values of Potential Clinical Concern|Hematology parameters included complete blood count with red blood cell indices and white blood cell differential, platelet count, human immune deficiency virus, Hepatitis C antibody and Hepatitis B surface antigen. Clinical chemistry parameters included blood urea nitrogen (BUN), creatinine, glucose, sodium, potassium, phosphate, chloride, total CO2, calcium, aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyltransferase (GGT), alkaline phosphatase, total bilirubin, uric acid, albumin and total protein. Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with clinical chemistry and hematology parameter values of potential clinical concern are presented.|Up to 24 hours post-treatment|Safety Population.|||Participants|||Count of Participants
1264190|NCT00404768|Primary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern|All scheduled 12-lead ECGs were obtained after the participant was rested in the semi-supine position for approximately 15 minutes. Whenever 12-lead ECGs were performed at the same nominal time as a blood draw or blood pressure and pulse rate measurement, the 12-lead ECG were obtained first. ECGs were repeated or recorded in triplicate and the average value recorded at the investigators discretion. The potential clinical concern range for ECG parameters were: Absolute QT corrected (QTc) interval: >450 milliseconds (msec), Increase from Baseline (Day 0): QTc >60 msec, PR interval: <110 and >220 msec and QRS interval: <75 and >110 msec. All 12-lead ECGs obtained throughout the study day were evaluated for safety and were reviewed by the investigator or investigator designee. Number of participants with electrocardiogram values of potential clinical concern are presented.|Up to Follow-up (Week 12)|Safety Population.|||Participants|||Count of Participants
1295304|NCT00084084|Primary|Patients Who Experienced At Least One Adverse Event (AE)||362 weeks|Safety Population: Patients in Cohort 1 who received at least one dose of Replagal RB in Phase 1.|||participants|||Number
1264191|NCT00404768|Primary|Number of Participants With Vital Sign Values of Potential Clinical Concern|Vital signs included blood pressure (systolic and diastolic) and heart rate. Maternal blood pressure and heart rate were measured with the participant in the semi-supine position. Blood pressure was measured in millimeters of mercury (mmHg) and heart rate in beats per minute (bpm). Potential clinical concern range for systolic blood pressure: <85 and >160 mmHg, for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 bpm. Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with vital sign values of potential clinical concern are presented.|Up to Follow-up (Week 12)|Safety Population which comprised of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1264192|NCT00404755|Secondary|Clinical Global Impression Scale (CGI)|"The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from~1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse)."|6 weeks or last visit in Phase||||units on a scale||Standard Deviation|Mean
1264193|NCT00404755|Primary|Hamilton Depression Scale (HAM-D)|Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63.|6 weeks or last visit in Phase|Participants were included if they were given that medication|||units on a scale||Standard Deviation|Mean
1264194|NCT00404651|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability|Day 0 (pre-each vaccination) up to 7 days post-each dose|Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome|||Participants|||Number
1264195|NCT00404651|Secondary|Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).|Day 150 (one month post-dose 3)|Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1264196|NCT00404651|Primary|Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine|Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).|Day 150 (one month post-dose 3)|Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
1264197|NCT00404651|Primary|Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.|Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.|Day 150 (one month post-dose 3)|Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
1264198|NCT00404651|Primary|Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.|Day 150 (one month post-dose 3)|Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.|||Participants|||Number
1264199|NCT00404547|Secondary|Assessment of Patient Treatment Satisfaction||12 weeks|||||||
1264200|NCT00404547|Secondary|Assessment of Patient Compliance During the Study||12 weeks|||||||
1264201|NCT00404547|Secondary|Change in Patient Assessment of Asthma Control|"Patient assessment of asthma control was assessed at baseline and at week 12 using the question How would you rate the control of your asthma symptoms?. The change in this assessment was categorized in Improvement and Non-Improvement."|At baseline and at week 12|Basis is the ITT population|||participants|||Number
1264202|NCT00404547|Primary|Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)|The score of the change from baseline ranges from –6 (=best possible outcome) to 6 (=worst possible outcome).|At the middle and end of the 12 week treatment period|Basis is the ITT population|||points on a scale||Standard Deviation|Mean
1264203|NCT00404495|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). Investigator's assessment.|Baseline to Date of Death (Up to 1 Year After Treatment)|All participants. One participant in the Temozolomide + Irinotecan for Medulloblastoma cohort did not have recurrent or refractory medulloblastoma and 3 participants in the Temozolomide + Irinotecan for High-Grade Glioma cohort did not have high-grade glioma, and were not considered evaluable for survival.|||months||95% Confidence Interval|Median
1264204|NCT00404495|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Tumor progression was determined from oncologic assessment data (where data met the criteria for PD). Investigator's assessment.|Baseline to Date of Progression (Up to 1 Year)|Evaluable local population|||months||95% Confidence Interval|Median
1264205|NCT00404495|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. Investigator's assessment.|Baseline to Date of Treatment Failure (Up to 1 Year)|Evaluable local population|||months||95% Confidence Interval|Median
1264206|NCT00404495|Secondary|Duration of Response|Median duration (50%) of tumor response for participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR was defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurred first. DR (calculated in Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. Investigator's assessment.|Baseline to Date of Tumor Response (Up to 1 Year)|Evaluable local population. Number of participants analyzed=number of participants who responded.|||weeks||Full Range|Median
1264207|NCT00404495|Secondary|Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR. CR persisted on repeat imaging study ≥4 weeks after initial documentation of response. PR, in case of bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response could be recorded any time while the participant was receiving treatment. Investigator's assessment.|Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)|Evaluable local population: Participants received at least 1 dose of study medication, had measurable disease under study, at least 1 on-study objective tumor assessment, completed at least 2 cycles of study treatment or progressed. Based on investigator's assessment.|||percentage of participants||95% Confidence Interval|Number
1264208|NCT00404495|Primary|Percentage of Participants With Objective Response of Complete Response or Partial Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.|Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)|Primary Evaluable Population: subset of evaluable population predetermined by 2-stage Optimum Simon design. Medulloblastoma cohort: n=consecutive evaluable participants up to 46 if 6 responses obtained in first 15 evaluable participants. Glioma cohort: n=consecutive evaluable participants up to 29 if 1 response in first 10 evaluable participants.|||percentage of participants||95% Confidence Interval|Number
1264209|NCT00404352|Secondary|Change From Baseline in Expanded Disability Status Score (EDSS) Score at Month 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.|Baseline, Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||unit on a scale||Standard Deviation|Mean
1264210|NCT00404352|Primary|Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Various time points from randomization up to 36 months|Open label (OL) ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period.|||days||95% Confidence Interval|Median
1264211|NCT00404352|Secondary|Change From Baseline in Time Constant 2 (T2) Lesion Volume , Time Constant 1 (T1) Hypointense Lesion Volume and Gadolinium Enhanced (Gd+) Lesion Volume at Month 36|Change from baseline in lesion volume was measured by using MRI scans for T2 lesions, T1 hypointense lesions and (Gd+) lesions.|Baseline, Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||cubic millimeter (mm^3)||Standard Deviation|Mean
1264212|NCT00404352|Secondary|Mean Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Hypointense Lesions Per Participant Per Scan|Number of CUA lesions, new T2 lesions, Gd+ lesions and new T1 hypointense lesions were measured by using MRI scans.|Month 24 up to Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||lesions||Standard Deviation|Mean
1264237|NCT00403845|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 4 hours post-dose on Day 1|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1264213|NCT00404352|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a 3-Month Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score|CDMS was defined by the occurrence of a second exacerbation or relapse over 36 months in participants who presented with FCDE accompanied by an abnormal MRI scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Various time points from randomization up to 36 months|OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period.|||days||95% Confidence Interval|Median
1264214|NCT00404352|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a 3-Month Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score|CDMS was defined by the occurrence of a second exacerbation or relapse over 24 months in participants who presented with first clinical demyelinating event (FCDE) accompanied by an abnormal MRI scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Various time points from randomization up to 24 months|ITT population included all participants who were randomized to the assigned study treatment.|||days||95% Confidence Interval|Median
1264215|NCT00404352|Primary|Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)|The McDonald criteria use dissemination in time and space established by magnetic resonance image (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Various time points from randomization up to 24 months|Intent-to-treat (ITT) population included all participants who were randomized to the assigned study treatment.|||days||95% Confidence Interval|Median
1264216|NCT00404248|Secondary|Survival|Survival measured from first day of treatment to date of death|time to death - up to 12 months|3 pts still alive at time of analysis|||months||Standard Deviation|Median
1264217|NCT00404248|Secondary|Efficacy - Best Overall Response|Response Criteria: Complete Response (CR): complete disappearance of all tumor, off all steroids, stable or improving neuro exam for min of 4wks; Partial Response (PR): Greater than 50% reduction in tumor size, bi-dimensional MRI/CT, stable steroids, stable or improving neuro for min of 4 wks; Progressive Disease (PD): Progressive neurologic abnormalities not explanined by causes unrelated to tumor progression, or 25% increase in size of tumor by MRI/CT scan, or if new lesion appears; Stable Disease (SD): patient whose clinical status and MRI/CT measurements do not meet the criteria for CR, PR or PD.|About 2 years|3 pt did not have proper scans to be evaluable for analysis|||participants|||Number
1264218|NCT00404248|Secondary|Pharmacokinetics - Terminal Phase Half-life|effect of hepatic enzyme-inducing drugs on PKs|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|no PKs for Arm 3 (All EIASD) were collected. Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis|||Hour||Standard Deviation|Mean
1264219|NCT00404248|Secondary|Pharmacokinetics - Steady-State Apparent Volume Distribution|"effect of hepatic enzyme-inducing drugs on PKs~Cycle 1 Day 1 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.~Cycle Day 5 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs."|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|no PKs were collected for Arm 3. Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis|||Liters||Standard Deviation|Mean
1264220|NCT00404248|Secondary|Pharmacokinetics - Total Body Clearance|"effect of hepatic enzyme-inducing drugs on PKs~Cycle 1 Day 1 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.~Cycle Day 5 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs."|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|No PKs were collected for the three patients who were treated on Arm 3 (all EIASD). Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis|||Liters/hour||Standard Deviation|Mean
1264221|NCT00404248|Primary|Maximum Tolerated Dose (Phase I) - Dose Limiting Toxicity (DLT)|Dose limiting Toxicity defined as: Treatment related events; absolute neutrophil count </=500 /mm3; platelets count </=25,000/mm3; febrile neutropenia; any grade 3 or 4 non-hematologic toxicity; any delay in starting subsequent course of treatment for >14 days because of incomplete recovery from treatment|First 30 days|"+EIASD on hepatic enzyme-inducing drugs; -EIASE not on hepatic enzyme-induzing drug or drugs that significantly induce the hepatic enzyme.~IV Formulations: +PEG; 10mg/mL solution of PEG 300, hydroxypropyl-B-cyclodextrin & water ; -PEG; 6mg/mL, hydroxypropyl-B-cyclodextrin & water - NEW TC6 formulation"|||Dose Limiting Toxicities (DLT)|||Number
1264222|NCT00404248|Primary|Maximum Tolerated Dose (Phase I)|Using the PEG formulation pts both with and without enzyme inducing antiseizure drugs (EIASD) were treated at Doses 750, 1100, 1700, 2200 mg/day for five days = 28pts Using the PEG free formulation pts with and without EIASD) were treated at 1700 and 2200 mg/day X 5 days = 8pgs|first 30 days of treatment||||mg/day x 5 days|||Number
1264223|NCT00404235|Secondary|Number of Treatment Cycles Administered|Number of treatment cycles administered is defined to be the number of treatment cycles administered until the patient is removed from treatment due to progression, toxicity, or refusal. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||cycles||Full Range|Median
1264224|NCT00404235|Secondary|Duration of Response|Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented.|Up to 3 years|Participants with Complete or Partial response, were analyzed|||months||Full Range|Median
1264225|NCT00404235|Secondary|Time to Disease Progression|Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||months||Full Range|Median
1264226|NCT00404235|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||months||Full Range|Median
1264227|NCT00404235|Primary|Tumor Response Rate, as Measured by RECIST Criteria|The RECIST criteria will be used for response assessments. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|Up to 2 years||||percentage of participants||90% Confidence Interval|Number
1264228|NCT00404092|Primary|Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis|Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria.|End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5)||||events|||Number
1264229|NCT00404092|Secondary|Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.|"Numbers of patients in each dose cohort according to invasive aspergillosis (IA) outcome at end of protocol treatment (EOT), 4 weeks follow-up (4w FU) and 12 weeks follow-up (12w FU), respectively. 12w FU was only required for patients with a CR or PR at the 4w FU.~Definitions:~CR: resolution of all attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.~PR: clinically meaningful improvement in attributable symptoms, signs, and radiographic (min. 50% decrease) or bronchoscopic abnormalities.~Stable disease (SD): no improvement in attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.~Failure: deterioration in attributable clinical or radiographic abnormalities necessitating alternative antifungal therapy or resulting in death.~Relapse: reemergence of IA after EOT following CR, PR or SD or early withdrawal."|End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-up|All 46 recruited patients were included in the analysis. 2 (EOT), 16 (4w FU) and 23 (12w FU) outcomes out of 46 were not recorded.|||participants|||Number
1264230|NCT00404079|Secondary|EuroQol-5D||1 year|||||||
1264231|NCT00404079|Secondary|Visual Analogue Scale||1 year|||||||
1264232|NCT00404079|Primary|Roland Morris Disability Questionnaire|The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.|1 year|The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation.|||units on a scale (0-24)||Standard Deviation|Mean
1264233|NCT00404066|Secondary|Disease-free Survival (DFS)|Disease-free survival (DFS) is expressed as the percentage of participants who were disease-free and alive at the time of analysis.|42 months (median follow-up)|DFS is reported as the number and percentage of participants who were alive and disease-free at the time of analysis.|||Participants|||Count of Participants
1264234|NCT00404066|Primary|Percentage of Participants With Pathologic Complete Response (pCR)|Pathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla, in participants who received at least 1 cycle of docetaxel and lapatinib and at least one follow-up evaluation.|12 weeks||||percentage of participants|||Number
1264235|NCT00403845|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.|||Liters||Standard Error|Least Squares Mean
1264236|NCT00403845|Secondary|Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||90% Confidence Interval|Least Squares Mean
1264238|NCT00403845|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.|||Liters||Standard Error|Least Squares Mean
1264239|NCT00403767|Secondary|All-cause Mortality|The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264240|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death|The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264241|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction|The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264242|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism|The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264243|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke|The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264244|NCT00403767|Secondary|The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death|The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264245|NCT00403767|Secondary|The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death|The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264246|NCT00403767|Primary|The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety|The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.|||Patients|||Number
1264247|NCT00403767|Primary|The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)|The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264248|NCT00403767|Primary|The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)|The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The per-protocol (PP) population consisted of all randomized unique patients excluding those who had specific pre-defined major protocol deviations that occurred by the time of enrollment into the study or during the trial. Site 042012 with GCP violation was excluded.|||Patients|||Number
1264261|NCT00403546|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score|CGI-I is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to baseline. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264249|NCT00403754|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 24 hours post dose was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1264250|NCT00403754|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 minutes to 4 hours post-dose on Day 1|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1264251|NCT00403754|Secondary|Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.|5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||90% Confidence Interval|Least Squares Mean
1264252|NCT00403754|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|22, 23, and 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1264253|NCT00403585|Secondary|Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event|The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.|Treatment Phase (Weeks 53-156)|ITT Population|||participants|||Number
1264254|NCT00403585|Secondary|Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156|Hepatitis B e antigen (HBeAg) loss, HBeAg seroconversion (defined as HBeAg negative and hepatitis B e antibody [HBeAb] positive), hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion (defined as HBsAg negative and hepatitis B surface antibody [HBsAb] positive). HBeAg and HBsAg seroconversion are defined as the loss (becoming negative) of HBeAg and the concurrent appearance of antibodies against HBeAg and the loss of HBsAg and the concurrent appearance of antibodies against HBsAg, respectively.|Week 104 and 156|All participants achieving viological response, defined as an HBV DNA level ≤ 300. Some participants were not tested at various weeks.|||Participants|||Number
1264255|NCT00403585|Secondary|HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156|Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.|Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156|Study ADF103814 ITT Population. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed. Some participants were not tested at various weeks.|||log 10 copies/mL||Standard Deviation|Mean
1264256|NCT00403585|Secondary|Number of Participants Achieving Virological Response at Week 104 & 156|Virological response is defined as HBV DNA level<300 copies/ml|Week 104, Week 156|ITT Population: some participants were not tested at Weeks 104 or 156.|||Participants|||Number
1264257|NCT00403585|Secondary|Number of Participants Achieving ALT Normalization at Week 104 & 156|Alanine aminotransferase (ALT) normalization is defined as a value <= upper limit of normal (ULN) range based on the set of subjects with ALT>ULN at baseline. The normal range for ALT is 0-40 Units/Liter.|Week 104, Week 156|ITT Population: some participants were not tested at Weeks 104 or 156.|||Participants|||Number
1264258|NCT00403585|Primary|Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy|HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL) after 3 years (156 weeks: Weeks 1-52 in Study ADF103814; Weeks 53-156 in Study 108005) of adefovir therapy). Change from baseline was calculated as the Week 156 value minus the Baseline value. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.|Baseline, Week 156|Study ADF103814 Intent-to-Treat (ITT) Population: All subjects regardless of whether or not the subject completed the planned duration of the study will be analyzed with no data exclusion. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1264259|NCT00403546|Secondary|Change in Schizophrenia Cognition Rating Scale (SCoRS) Score|SCoRS is a 20 item interview-based clinical assessment that evaluates cognitive deficits and the degree to which these deficits impair participants’ day-to-day functioning. The following cognitive domains are assessed: attention, memory, working memory, language production, reasoning, problem solving, motor skills, and social cognition. Score ranges from 1 to 10 with a higher score indicating a greater degree of impairment. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264260|NCT00403546|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score|GAF is a numeric scale used to rate social, occupational, and psychological functioning of participants. Scores range from 100 (extremely high functioning) to 1 (severely impaired). A positive change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264262|NCT00403546|Secondary|Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score|CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with subjects who have the same diagnosis. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264263|NCT00403546|Secondary|Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score|The CDRS was used to assess the level of depression in participants with schizophrenia. The questionnaire consists of 9 questions rated on a 4-point scale from 0 to 3. Total range is 0 to 27 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264264|NCT00403546|Secondary|Change From Baseline in PANSS Negative Subscale Score|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Negative symptoms as defined by the American Psychiatric Association represent a diminution or loss of normal functions and include the following 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264265|NCT00403546|Secondary|Change From Baseline in Positive Subscale Score of PANSS|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Positive symptoms as defined by the American Psychiatric Association refer to an excess or distortion of normal functions and include the following 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution and hostility. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264266|NCT00403546|Primary|Number of Treatment-emergent Adverse Events During Randomized Trial|Adverse event: any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Serious adverse event (SAE): significant hazard, contraindication, side effect, or precaution, which fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|From Baseline up to Week 8|Safety population includes all participants who received at least one dose of study medication.|||adverse events|||Number
1264267|NCT00403546|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score|AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0–4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264268|NCT00403546|Primary|Percentage of Participants With Response|Response was defined as a reduction in the PANSS total score from baseline by 20% or greater, calculated by first subtracting 30 (the PANSS minimum possible total score). Response rate is the percentage of participants with a response.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point|||percentage of participants|||Number
1264269|NCT00403546|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Total PANSS score consists of 7 items in the Negative subscale, 7 items in the Positive subscale and 16 items in the General Psychopathology scale. Total PANSS score ranges from 30 to 210. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264270|NCT00403546|Primary|Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)|QT interval is a measure of the time between the start of the Q wave and the end of the T wave as determined by electrocardiogram (EKG). The corrected QT Interval (QTc) adjusts the QT interval for heart rate. The number of participants with an increase to QTc interval >/= 500 msec was reported.|6 hours after dosing of Weeks 1, 2 and 8|All participants with available data at each time point.|||participants|||Number
1264271|NCT00403546|Primary|Vital Signs: Systolic and Diastolic Blood Pressure Levels|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at regular times during the study. Normal SBP is defined as 120 millimeters of mercury (mmHg) or below and normal DBP is defined as 80 mmHg or below. Change from baseline is indicated for each time point. A positive change from baseline indicates and increase in blood pressure and a negative change from baseline indicates a decrease.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||mmHg||Standard Deviation|Mean
1264313|NCT00403130|Primary|Time-to-Progression (TTP)|Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans.|2 years|Disease progression was documented for 9 participants.|||months||Standard Deviation|Median
1265637|NCT00394654|Secondary|Time to Observed Maximum Nasal Lavage Concentration (Tmax)|Tmax of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528|||Day||Geometric Coefficient of Variation|Geometric Mean
1264272|NCT00403546|Primary|Number of Participants With High and Low Levels in Serum Prolactin Concentration|Blood samples were taken at baseline and Week 8 to measure serum prolactin concentrations. Normal range for females (non-pregnant) is 2-29 nanograms per deciliter (ng/dL) and for males 2-18 ng/dL. Values above the normal range were reported as High and values below the normal range were reported as Low. Reported here is the number of participants with high prolactin concentration and the number of participants with low prolactin concentration.|Baseline, Week 8|All participants with available data at each time point.|||participants|||Number
1264273|NCT00403546|Primary|Change From Baseline in the Barnes Akathisia Scale (BAS)|BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0 – 3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0 – 5. Total score ranges from 0 to 14 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants who had available data at each time point.|||units on a scale||Standard Deviation|Mean
1264274|NCT00403546|Primary|Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)|The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.|Baseline, Week 2, Week 4, Week 6, Week 8|All study participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1264275|NCT00403546|Primary|Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial|Side effects were tracked using the Side Effect Checklist for ziprasidone, which is a well-validated 17 item scale that records the presence or absence of side effects. Total number of side effect events is reported here.|From Baseline up to Week 8|All participants in the randomized trial.|||side effect events|||Number
1264276|NCT00403481|Secondary|Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.|||mm Hg||Standard Error|Mean
1264277|NCT00403481|Secondary|Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 Weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 participants, only 169 had the required measurements for this outcome analysis.|||mm Hg||Standard Error|Mean
1264278|NCT00403481|Secondary|Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
1264279|NCT00403481|Secondary|Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
1264280|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements|||mm Hg||Standard Error|Mean
1264281|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.|||mm Hg||Standard Error|Mean
1264282|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 169 had the required measurements for this outcome analysis.|||mm Hg||Standard Error|Mean
1264283|NCT00403481|Secondary|Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
1264284|NCT00403481|Primary|Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
1264285|NCT00403455|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS assessment is used to determine the severity of an individuals PTSD. The assessment examines Re-experiencing, Avoidance and Numbing, and Hyperarousal symptoms which total score in each of these categories are added together to achieve a total CAPS score. Scores on this assessment can range from 0-136 with 0 not having any PTSD symptoms and 136 having the most symptoms possible. The study uses this assessment at the baseline and at the end of treatment to determine the decrease in this score over the course of the study.|12 weeks|All participants analyzed had a CAPS score of >45 and were DSM-IV positive for PTSD. Both males and females with backgrounds in all ethnic groups were aloud to participate in the study.|||Change in units on a scale||Full Range|Mean
1264286|NCT00403403|Secondary|Duration of Objective Response|Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.|Randomization until progression or lost to follow-up (up to 2 years)|Randomized patients with measurable disease at baseline.|||Months||95% Confidence Interval|Median
1264287|NCT00403403|Secondary|Number of Participants With an Objective Response|"Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.~Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):~Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR"|Randomization until progression or lost to follow-up (up to 2 years)||||number of participants|||Number
1264288|NCT00403403|Secondary|Percentage of Participants With an Objective Response|"Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.~Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):~Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR"|Randomization until progression or lost to follow-up (up to 2 years)|Intent-to-treat population|||Percentage of participants|||Number
1264289|NCT00403403|Secondary|Overall Survival|Duration of overall survival from randomization until death or loss to follow-up|Randomization until death or lost of follow-up (up to 27 months)|Intent-to-treat population|||Months||95% Confidence Interval|Median
1264290|NCT00403403|Primary|Progression-free Survival (PFS)|Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.|Randomization until progression or lost to follow-up (up to 2 years)|Intent-to-treat population|||Months||95% Confidence Interval|Median
1264291|NCT00403390|Primary|Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug.||3 points over 16 weeks||||uIU/mL||Standard Error|Mean
1264292|NCT00403273|Secondary|Change in Serum Cytokine (Tumor Necrosis Factor Alpha) Levels at 2-month Post-injection|The change in serum tumor necrosis factor alpha was defined as the difference between the follow-up (2-month) and the baseline value of serum tumor necrosis factor alpha. We compared the mean change in serum tumor necrosis factor alpha levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
1264293|NCT00403273|Secondary|Change in Serum Cytokine (Interferon Gamma) Levels at 2-month Post-injection|The change in serum Interferon Gamma was defined as the difference between the follow-up (2-month) and the baseline value of serum Interferon Gamma. We compared the mean change in serum Interferon Gamma levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
1264294|NCT00403273|Secondary|Change in Serum Cytokine (Eotaxin) Levels at 2-month Post-injection|The change in serum Eotaxin was defined as the difference between the follow-up (2-month) and the baseline value of serum Eotaxin. We compared the mean change in serum Eotaxin levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
1264295|NCT00403273|Secondary|Change in Serum Cytokine (Interleukin 12 p70) Levels at 2-month Post-injection|The change in serum interleukin 12 p70 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 12 p70. We compared the mean change in serum interleukin 12 p70 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
1264314|NCT00403117|Primary|Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.|Change in mean heart rate as a function of marijuana and naltrexone dose|Baseline compared to 6 week timepoint|A total of 29 participants were included in the final analysis|||Heart rate (beats/minute)||Standard Deviation|Mean
1264296|NCT00403273|Secondary|Change in Serum Cytokine (Interleukin 10) Levels at 2-month Post-injection|The change in serum interleukin 10 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 10. We compared the mean change in serum interleukin 10 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
1264297|NCT00403273|Secondary|McGill Sensory Pain Score|McGill Sensory pain score on 0-33 at 2-month FU visit (higher score is worse)|2-month|patients providing data|||units on a scale||Standard Deviation|Mean
1264298|NCT00403273|Secondary|Change in Serum Cytokine (Interleukin 7) Levels at 2-month Post-injection|The change in serum interleukin 7 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 7. We compared the mean change in serum interleukin 7 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
1264299|NCT00403273|Secondary|McGill Affective Dimension|McGill Affective Dimension Score on 0-12 scale at 2-months (higher number is worse)|2-month|patients providing data|||units on a scale||Standard Deviation|Mean
1264300|NCT00403273|Secondary|Manual Muscle Strength Testing of Knee Flexion and Extension|Occurence of decrease in strength of knee flexion or extension at any of the follow-up visits, as measured by the Manual muscle strength testing (MMT) with scores ranging 0-5; 0 indicates None: No visible or palpable contraction; 1 indicates Trace: Visible or palpable contraction with no motion; 2 indicates Poor: Full range of motion (ROM) gravity eliminated; 3 indicates Fair: Full ROM against gravity; 4 indicates Good: Full ROM against gravity, moderate resistance; and 5 indicates Normal: Full ROM against gravity, maximal resistance|Upto 6-months|patients providing the data|||participants|||Number
1264301|NCT00403273|Secondary|Number of Participants With Occurrence of Joint Erythema, Warmth, Swelling or Tenderness|Occurence of any of the above clinical features (erythema, warmth, swelling or tenderness) as a new finding compared to the absence of the same feature at baseline|Upto 6 months|patients providing data|||participants|||Number
1264302|NCT00403273|Secondary|QOL: SF-36 Score Physical Functioning Scale, a Generic Health Status Measure|Short Form (SF)-36 physical functioning subscale on 0-100, at 2-month FU visit, as a generic health status measure, with a score ranging from 0 (worst physical functioning) to 100 (best physical functioning), with higher score indicating better physical functioning (higher number is better)|2-month|patients providing data|||units on a scale||Standard Deviation|Mean
1264303|NCT00403273|Secondary|Timed Up-and-go (TUG) Test|Time to get up from a chair, walk 3 meters turn back and sit in the chair in seconds at the 2-month visit (higher number is worse, i.e., taking a longer time to complete the task is worse)|2-month|patients providing data|||seconds||Standard Deviation|Mean
1264304|NCT00403273|Secondary|WOMAC Stiffness (0-100)|WOMAC stiffness subscale score on 0-100 scale at 2-month follow-up visit with scores ranging 0 (no joint stiffness) to 100 (worst joint stiffness), with higher score indicating worse joint stiffness|2-months|patients providing the data|||units on a scale||Standard Deviation|Mean
1264305|NCT00403273|Secondary|Physical Function Subscale of the WOMAC at 2-months|Physical Function subscale score of the WOMAC at 2-months on a 0 (best physical function) to 100 (worst physical function), with higher score indicating worse physical function|2-month|people providing data at 2-months|||units on a scale||Standard Deviation|Mean
1264306|NCT00403273|Secondary|Physician Global Assessment of Response to Treatment|Physician global assessed on an ordinal scale with very much improved category as the outcome of interest (compared to all other categories of global assessment as reference category)|2-month (primary end-point)|2 patients did not have the outcome assessment; 1 lost to FU|||participants|||Number
1264307|NCT00403273|Secondary|Mean Pain VAS (0-10)|VAS pain score at 2-month post-injection; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain) with higher score indicating worse pain|2-months post-injection|patients providing pain VAS data at 2-month FU visit|||units on pain VAS scale||Standard Deviation|Mean
1264308|NCT00403273|Primary|Participants With Clinically Meaningful Improvement in Pain Severity (0-10 cm; Higher Score on Pain Scale is Worse)|2-point reduction in pain Visual Analog Scale (VAS) from baseline to the 2-month follow-up visit, which is considered clinically meaningful Change in Pain Severity; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain)|2-month post-injection|all with follow-up data, allowing only single TKA per participant|||participants|||Number
1264309|NCT00403234|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.|From signed informed consent to 7 days after end of study (approx. 35 days)|The Safety Population consisted of subjects who were randomized, received at least 1 dose of double-blind study drug and had at least 1 safety assessment during double-blind treatment.|||participants|||Number
1264310|NCT00403130|Secondary|Overall Survival (OS), All Participants|Overall Survival (OS), based on date of death or last known date alive|6 years||||months||Full Range|Median
1264311|NCT00403130|Secondary|Overall Survival (OS), Confirmed|Overall Survival (OS) as determined by confirmed date of death|6 years||||months||Full Range|Median
1264312|NCT00403130|Secondary|Response Rates|"The best overall response was recorded for each participant from randomization until disease progression/recurrence, using any increase from the smallest measurements recorded since randomization as the indicator of Progressive Disease (PD).~Overall response was determined on the basis of response at the target and non-target lesions, and the appearance of new lesions, as follows.~Target Nontarget New Lesions Overall Response~Complete Complete None Overall Complete Response~Complete Incomplete response/ None Overall Partial Response Stable Disease (SD)~Partial Not PD None Overall Partial Response~SD Not PD None Overall Stable Disease~PD Any Yes/No Overall PD~Any PD Yes/No Overall PD~Any Any Yes Overall PD~Overall Response Rate (ORR) was assessed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate."|24 weeks|Although 24 participants completed treatment, only 13 were evaluable for treatment effect.|||Participants|||Count of Participants
1264315|NCT00403117|Primary|Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose|"Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90.~The task batteries included total correct attempts on a 3-min DSST."|Baseline compared to 6 week timepoint|Data from 29 participants were included in this analysis|||units on a scale||Standard Error|Mean
1264316|NCT00403117|Primary|Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.|"All subjective effects were measured using visual analog scales (VAS), a series of 100 mm long lines labeled ‘not at all’ at one end (0 mm) and ‘extremely’ at the other end (100 mm). Participants were instructed to rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana high, good effects of marijuana, and how much marijuana was liked.~Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana– placebo naltrexone condition was compared to the active marijuana–active naltrexone conditions (four comparisons)"|Baseline compared to 6 week timepoint|Data from 29 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
1264317|NCT00402987|Other Pre-specified|No Perceptible Relief|Subjects having No Perceptible Relief at each time point. No Perceptible relief is score = 0 on Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief).|up to 24 hours|"MITT population~Number of subjects at each time point (in hour) is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo"|||subjects|||Number
1264318|NCT00402987|Other Pre-specified|First Perceptible Relief|Subjects having First Perceptible Relief at each time point. Perceptible relief is score >0 on Sore Throat Relief Rating Scale(STRRS)(range: 0=no relief to 6=complete relief).|up to 24 hours|"MITT population~Number of subjects assessed at each hour is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo"|||subjects|||Number
1264319|NCT00402987|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM vII)|11 questions scored on factors: effectiveness, side effects, convenience, overall satisfaction. TSQM vII scores range 0 to 100, with higher scores indicating a higher level of global satisfaction with treatment.|24 hours or immediately prior to taking rescue medication|MITT population|||scores on a scale||Standard Deviation|Mean
1264320|NCT00402987|Other Pre-specified|Subjects Taking Rescue Medication|Subjects were allowed to use rescue medication at any time during the trial, but were discouraged from taking rescue medication within 2 hours of administration of the first dose of study drug.|Within 24 hours Post-First Dose|MITT population|||subjects|||Number
1264321|NCT00402987|Other Pre-specified|Treatment Failures on STRRS Questionnaire|Subjects were considered treatment failures if all of the STRRS scores were less than each individual's 'meaningful relief' scores. STRRS score ranges from 0=no relief to 6=complete relief.|24 hours Post-First Dose|MITT population|||subjects|||Number
1264322|NCT00402987|Other Pre-specified|Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose|Offset time is time of first no perceptible relief (STRRS score=0) with meaningful relief (score>0) at earlier time. STRRS score ranges from 0=no relief to 6=complete relief.|24 Hours|Number of subjects who achieved Meaningful Relief within 6 hours|||hours||Full Range|Median
1264323|NCT00402987|Other Pre-specified|Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose|Perceptible Relief is score >0 on STRRS. Individual level of meaningful relief had to be reached within 6 hours. Meaningful Relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief)score at the end of the study was the same or higher than individually defined meaningful relief score during the study.|24 Hours|Number of subjects who achieved meaningful relief within 6 hours|||hours||Full Range|Median
1264324|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose|At end of study subjects defined meaningful pain relief by completing the Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief) score at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0|12 and 24 hours Post-First Dose|MITT population|||subjects|||Number
1264325|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour|At end of study subjects defined meaningful pain relief by completing Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS) score (range: 0=no relief to 6=complete relief) at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0.|Within 6 hours Post-First Dose|MITT population|||subjects|||Number
1264326|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose|Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.|12 hours Post-First Dose|MITT population|||subjects|||Number
1264327|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose|Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.|2 and 6 hours Post-First Dose|MITT population|||subjects|||Number
1264328|NCT00402987|Other Pre-specified|Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose|>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at 12 hours and at baseline.|12 hours Post-First Dose|MITT population|||subjects|||Number
1264329|NCT00402987|Other Pre-specified|Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose|>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at the time and at baseline.|2 and 6 hours Post-First Dose|MITT population|||subjects|||Number
1264330|NCT00402987|Other Pre-specified|Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose|NNT is number of subjects needed to treat to have one subject report a 50% or better pain relief over 12 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 12 hours is 72. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.|12 hours Post-First Dose|MITT population Comparison Celecoxib 100mg/50mg - Placebo: the NNT value was non-estimable|||subjects|||Number
1264331|NCT00402987|Other Pre-specified|Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose|NNT is number of subjects needed to treat to have one extra subject report a 50% or better pain relief over 6 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 6 hours is 36. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.|6 hours Post-First Dose|MITT population|||subjects|||Number
1264332|NCT00402987|Other Pre-specified|Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 12 hours is 72. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.|12 hours Post-First Dose|MITT population|||subjects|||Number
1264333|NCT00402987|Other Pre-specified|Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 6 hours is 36. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.|6 hours Post-First Dose|MITT population|||subjects|||Number
1264334|NCT00402987|Other Pre-specified|Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).|12 and 24 hours Post-First Dose|"Subjects evaluated at 24 hours: 84 for 50mg/50mg; 43 for 100mg/Placebo; 44 for 100mg/50mg; 81 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
1264335|NCT00402987|Other Pre-specified|Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).|2 and 6 hours Post-First Dose|"Subjects evaluated at 6 hours: 85 for 50mg/50mg; 87 for 100mg (pooled); 85 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
1264336|NCT00402987|Other Pre-specified|Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose|Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 12 hours and at baseline.|At 12 Hours|MITT population|||subjects|||Number
1264337|NCT00402987|Other Pre-specified|Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose|Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 6 hours and at baseline.|At 6 hours|MITT population|||subjects|||Number
1264338|NCT00402987|Other Pre-specified|Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
1264339|NCT00402987|Other Pre-specified|Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
1264340|NCT00402987|Other Pre-specified|Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose|SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline.|Over 2 hour Period Post-First Dose|MITT population|||units on a scale * hours||Standard Error|Least Squares Mean
1264341|NCT00402987|Other Pre-specified|Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose|The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale||Standard Error|Least Squares Mean
1264342|NCT00402987|Other Pre-specified|Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose|The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||units on a scale||Standard Error|Least Squares Mean
1264343|NCT00402987|Other Pre-specified|Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose|The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
1264344|NCT00402987|Other Pre-specified|Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose|The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population~At 15min the SE was <0.01 for all 3 groups"|||units on a scale * hours||Standard Error|Least Squares Mean
1264345|NCT00402987|Other Pre-specified|Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose|SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS scale: 0=not sore to 10=very sore) at 2 hours post dose and at baseline.|2 hour period Post-First Dose|MITT population|||units on a scale * hours||Standard Error|Least Squares Mean
1264346|NCT00402987|Other Pre-specified|Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose|The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.|7 to 24 hours post-first dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
1264347|NCT00402987|Other Pre-specified|Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose|The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.|Within first 6 hours post-first dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
1264348|NCT00402987|Secondary|Patient’s Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose|Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)|12 and 24 hours Post-First Dose|"Subjects analyzed at 24 hours were different for 2 groups: Celecoxib 100mg/Placebo=45 and Placebo=87.~MITT population"|||subjects|||Number
1264349|NCT00402987|Secondary|Patient’s Global Evaluation of Study Medication at 6 Hours Post-First Dose|Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)|6 Hours Post-First Dose|MITT population|||subjects|||Number
1264350|NCT00402987|Secondary|Time to Onset of Analgesia|Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported|Within 2 Hours Post-First Dose|"MITT population.~The median time to onset of analgesia, including all subjects, was >2 hours in each group (time was censored at 2 hours).~Median time and CI were not estimable."|||subjects|||Number
1264351|NCT00402987|Secondary|Time to Meaningful Pain Relief|The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported|Within 2 Hours Post-First Dose|"MITT population.~The median time to meaningful pain relief, including all subjects, was >2 hours in each group (time was censored at 2 hours)~Median time and CI were not estimable"|||subjects|||Number
1264352|NCT00402987|Secondary|Time to Perceptible Pain Relief|Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug|Within 2 Hours Post-First Dose|"MITT population.~Number of Subjects achieving perceptible pain relief: 77 for celecoxib 50mg/50mg; 67 for celecoxib 100mg (pooled); 46 for placebo~Upper 95% CI for placebo group was >120"|||minutes||95% Confidence Interval|Median
1264353|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) - ‘Moderate Relief’ at 12 Hours Post-First Dose|Subjects Achieving at Least ‘Moderate Relief’ as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).|12 hours|MITT population|||subjects|||Number
1264354|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) - ‘Moderate Relief’ at 6 Hours Post-First Dose|Subjects Achieving at Least ‘Moderate Relief’ as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).|at 6 hours|MITT population|||subjects|||Number
1264355|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose|STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
1264356|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose|STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.|within the first 6 hours|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
1264357|NCT00402987|Secondary|Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
1264445|NCT00402324|Secondary|Number of Patients Hospitalized Due to Relapse of Mania or Depression.|Number of participants hospitalized as a result of relapse of mania or depression.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients.|||participants|||Number
1264358|NCT00402987|Secondary|Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.|up to 6 hours|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
1264359|NCT00402987|Secondary|Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose|Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale||Standard Error|Least Squares Mean
1264360|NCT00402987|Secondary|Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose|Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|Within First 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||units on a scale||Standard Error|Least Squares Mean
1264361|NCT00402987|Primary|Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose|Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.|2 hours Post-First Dose|Modified intent-to-treat (MITT) population, defined as all subjects randomized to treatment who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. The celecoxib 100mg (pooled) treatment group and placebo were compared for the primary endpoint. Celecoxib 50mg/50mg group was not in this analysis.|||units on a scale * hours||Standard Error|Least Squares Mean
1264362|NCT00402896|Primary|Median Time to Pleurodesis|Time to pleurodesis from initiation of treatment to catheter removal as measure of pleural effusion Improvement (amount of pleural fluid drainage) where objective was to examine whether ZD6474 would help participants to improve the condition of pleural effusion, and thus remove the catheter earlier. Cox model analysis applied to examine the effect of covariates on the time to catheter removal.|Time from initiation of treatment and catheter insertion up to a maximum of 10 weeks|Twenty eligible participants were analyzed for the primary outcome in the trial, eleven completed 10 weeks of treatment. All twenty participants completed the study.|||Days||95% Confidence Interval|Median
1264363|NCT00402883|Secondary|Overall Survival||18 months|||||||
1264364|NCT00402883|Secondary|To Evaluate the Objective Response Rates||18 months|||||||
1264365|NCT00402883|Primary|Time to Progression||18 months|No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.||||||
1264366|NCT00402831|Secondary|Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose|An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP.|From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)||||Percentage of participants|||Number
1264367|NCT00402831|Secondary|Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose|An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.|From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)|All participants who received at least one dose of study drug and had safety follow-up data are included.|||Percentage of participants|||Number
1264368|NCT00402831|Secondary|Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose|An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.|From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)|All participants who received at least one dose of study drug and had safety follow-up data are included.|||Percentage of participants|||Number
1264369|NCT00402831|Secondary|Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment|Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to varicella and who had post-vaccination serology results were included.|||Antibody titres (gpELISA units/mL)||95% Confidence Interval|Geometric Mean
1264370|NCT00402831|Secondary|Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment|Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to rubella and who had post-vaccination serology results were included.|||Antibody titres (IU/mL)||95% Confidence Interval|Geometric Mean
1264371|NCT00402831|Secondary|Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment|Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre <10 ELISA Ab units mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to mumps and who had post-vaccination serology results were included.|||Antibody titres (ELISA Ab units/mL)||95% Confidence Interval|Geometric Mean
1264372|NCT00402831|Secondary|Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment|Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to measles and who had post-vaccination serology results were included.|||Antibody titres (mIU/mL)||95% Confidence Interval|Geometric Mean
1264373|NCT00402831|Secondary|Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose|Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL.|Week 4|Participants who were initially seronegative to varicella and who had post-vaccination serology results were included.|||Antibody titres (gpELISA units/mL)||95% Confidence Interval|Geometric Mean
1264374|NCT00402831|Secondary|Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose|Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL.|Week 4|Participants who were initially seronegative to rubella and who had post-vaccination serology results were included.|||Antibody titres (IU/mL)||95% Confidence Interval|Geometric Mean
1264375|NCT00402831|Secondary|Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose|Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres <10 ELISA Ab units mL.|Week 4|Participants who were initially seronegative to mumps and who had post-vaccination serology results were included.|||Antibody titres (ELISA Ab units/mL)||95% Confidence Interval|Geometric Mean
1264376|NCT00402831|Secondary|Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose|Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL.|Week 4|Participants who were initially seronegative to measles and who had post-vaccination serology results were included.|||Antibody titres (mIU/mL)||95% Confidence Interval|Geometric Mean
1264377|NCT00402831|Secondary|Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose|Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Week 4|Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.|||Percentage of participants||95% Confidence Interval|Number
1264378|NCT00402831|Primary|Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment|Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.|||Percentage of participants||95% Confidence Interval|Number
1264379|NCT00402740|Secondary|Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.||3 years|ITT|||Event-free percentage|||Number
1264380|NCT00402740|Secondary|Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax|Includes only each subject's first occurrence of each event.|≤30 days|ITT|||percentage of participants||95% Confidence Interval|Number
1264381|NCT00402740|Secondary|Procedural Success|Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.|30 Days|ITT|||percentage of participants||95% Confidence Interval|Number
1264382|NCT00402740|Secondary|Acute Device Success|Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.|Post-procedure|ITT|||percentage of participants||95% Confidence Interval|Number
1264383|NCT00402740|Primary|Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.|Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.|3 years|Intent to Treat (ITT)|||Event-free percentage|||Number
1264384|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 14 – 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population|BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.|14 - 28 days after last dose of study medication|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.|||percentage of participants|||Number
1264528|NCT00401960|Primary|Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria|Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline|weekly|study terminated due to inadequate enrollment; therefore data not sufficient for planned analysis|||Participants|||Count of Participants
1264385|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 14 – 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms|BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.|14 - 28 days after last dose of study medication|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.|||percentage of participants|||Number
1264386|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 7 – 21 Days of Treatment in the Microbiological Valid (MBV) Population|Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.|after 7 - 21 days of treatment|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.|||percentage of participants|||Number
1264387|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 7 – 21 Days of Treatment in the ITT Population With Causative Organisms|Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.|after 7 - 21 days of treatment|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.|||percentage of participants|||Number
1264388|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population|Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.|3 - 5 days after start of treatment|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.|||percentage of participants|||Number
1264389|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms|Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.|3 - 5 days after start of treatment|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.|||percentage of participants|||Number
1264390|NCT00402727|Secondary|Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population|Clinical response was evaluated by the investigator and graded as “resolution”, or “failure to respond,” or “indeterminate” at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|after 7 - 21 days of treatment|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.|||percentage of participants|||Number
1264391|NCT00402727|Secondary|Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population|Clinical response was evaluated by the investigator and graded as “resolution,” or “failure to respond,” or “indeterminate” at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|after 7 - 21 days of treatment|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.|||percentage of participants|||Number
1264392|NCT00402727|Secondary|Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population|Clinical response was evaluated by the investigator and graded as “improvement in signs and symptoms,” or “failure to respond,” or “indeterminate” at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs|3 - 5 days after start of treatment|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.|||percentage of participants|||Number
1264393|NCT00402727|Secondary|Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population|Clinical response was evaluated by the investigator and graded as “improvement in signs and symptoms,” or “failure to respond,” or “indeterminate” at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|3 - 5 days after start of treatment|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.|||percentage of participants|||Number
1264529|NCT00401960|Primary|Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)|Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details|weekly|Study terminated due to insufficient enrollment; therefore data not sufficient for planned analysis|||Participants|||Count of Participants
1264394|NCT00402727|Secondary|Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population|Clinical response was evaluated by the DRC and graded as “cure”, “failure” or “indeterminate” at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|14 - 28 days after last dose of study medication|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as all randomized subject that received at least one dose of study medication and had at least one observation after intake of study drug.|||percentage of participants|||Number
1264395|NCT00402727|Primary|Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population|Clinical response was evaluated by the DRC and graded as “cure”, “failure” or “indeterminate” at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|14 - 28 days after last dose of study medication|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.|||percentage of participants|||Number
1264396|NCT00402714|Secondary|Overall Survival||2 years following stem cell transplant||||participants|||Number
1264397|NCT00402714|Primary|Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis||Day +100 following allogeneic stem cell transplant||||participants|||Number
1264398|NCT00402688|Secondary|Total NIH-CPSI Score|National Institute of Health-Chronic Prostatitis Symptom Index numerically rates a total score (0-43) where 0 indicates no symptoms across any of the domains (pain or discomfort, urination, quality of life).|Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)|Modified Intent to Treat (mITT)|||Score on a scale||Full Range|Mean
1264399|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone Contact at 6 Months|Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)|||Participants|||Number
1264400|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone contact at 3 Months|Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)|||Participants|||Number
1264401|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone contact at 6 weeks|Modified Intent-to-Treat Population (mITT) (Participants Cured/Improved at the Posttherapy Visit)|||participants|||Number
1264402|NCT00402688|Secondary|Symptom Relief (Resolved)|Participants With Resolution of Prostatitis Signs and Symptoms; Resolution is defined as symptoms present (mild, moderate or severe) at Screening/Admission and absent (none) at the Posttherapy evaluation.|Posttherapy Visit (Study Day 33-36)|Modified Intent to Treat (mITT)|||Participants|||Number
1264403|NCT00402688|Primary|Clinical Success|Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.|Posttherapy Visit (Study Day 33-36)|Modified Intent to Treat (mITT)|||Participants|||Number
1264404|NCT00402649|Primary|Occurrence of Serious Adverse Events|Number of subjects with Serious Adverse Events during the 6 months after the first vaccination.|6 months after the first vaccination||||Participants|||Number
1264405|NCT00402649|Primary|Occurrence of Unsolicited Adverse Events|Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.|Through Day 28 after second vaccination||||Participants|||Number
1264406|NCT00402649|Primary|Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10|Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.|Days 0-7 post each vaccination|Solicited symptom of Body Aches was collected from subjects age 6-10 only|||Participants|||Number
1264407|NCT00402649|Secondary|Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers|Number of subjects with a 4-fold or greater increase, relative to baseline, in hemagglutination inhibition antibody titers after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants post vaccination, but missing baseline assessment for 3 of 16 subjects|||Participants|||Number
1264408|NCT00402649|Secondary|Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers|Geometric mean titer of hemagglutination inhibition antibody titers after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants|||Titer||95% Confidence Interval|Geometric Mean
1264409|NCT00402649|Secondary|Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater|Number of subjects achieving serum hemagglutination inhibition antibody titer of 1:40 or greater against the influenza A/H5N1 virus after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants|||Participants|||Number
1264410|NCT00402649|Primary|Occurrence of Solicited Adverse Events Among All Subjects|Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.|Days 0-7 post each vaccination||||Participants|||Number
1264446|NCT00402324|Secondary|Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint|CGI-BP Severity is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline to endpoint (6 weeks)|Intent to Treat analysis. Number of randomized patients with baseline and at least one nonmissing postbaseline value. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1264411|NCT00402597|Secondary|The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit|The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.|||Patients|||Number
1264412|NCT00402597|Secondary|The Number of Deaths (All Cause)|The number of patients who died due to any cause from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.|||Patients|||Number
1264413|NCT00402597|Secondary|The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke|The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment regardless of study drug intake.|||Patients|||Number
1264414|NCT00402597|Secondary|The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke|The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardliess of study drug intake.|||Patients|||Number
1264415|NCT00402597|Primary|The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)|The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The intent-to-treat (ITT) population consisted of all patients who were randomized to treatment, regardless of study drug intake.|||Patients|||Number
1264416|NCT00402597|Primary|Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)|The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.|Day 1 to Day 210|The safety population consisted of all randomized patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.|||Patients|||Number
1264417|NCT00402363|Secondary|Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period|Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants with an event.|||recurrences||Inter-Quartile Range|Median
1264418|NCT00402363|Secondary|Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period|Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants with an event.|||recurrences||Inter-Quartile Range|Median
1264419|NCT00402363|Secondary|Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period|Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants who had a rescue episode.|||rescue episodes||Inter-Quartile Range|Median
1264420|NCT00402363|Secondary|Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.|||participants|||Number
1264421|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.|||participants|||Number
1264422|NCT00402363|Secondary|Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.|||participants|||Number
1264530|NCT00401882|Secondary|Need for Additional Antiarrhythmic Drugs||120 minutes|Data point not analyzed||||||
1264531|NCT00401882|Secondary|Total Duration of Resuscitative Efforts||120 minutes|Data point not analyzed||||||
1264423|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.|||participants|||Number
1264424|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)|MITT Population|||participants|||Number
1264425|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)|MITT Population|||participants|||Number
1264426|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter|"A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)|MITT Population|||participants|||Number
1264427|NCT00402363|Secondary|Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter|"A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)|MITT Population|||participants|||Number
1264428|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)|MITT Population|||participants|||Number
1264429|NCT00402363|Secondary|Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)|MITT Population|||participants|||Number
1264430|NCT00402363|Secondary|Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population|||participants|||Number
1264431|NCT00402363|Primary|Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter|"A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)|Modified Intent-to-Treat (MITT) Population: all randomized participants who provided at least one post-randomization TTM ECG data transfer or equivalent|||participants|||Number
1264473|NCT00402233|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)|From baseline to week 12|Treated set|||units on a scale||Standard Deviation|Mean
1264474|NCT00402194|Primary|Insulin-stimulated Leg Glucose Uptake||3 months||||mmol/min||Standard Deviation|Mean
1264432|NCT00402337|Secondary|Change From Baseline in Straining Score for the Treatment Period|Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis."|||units on a scale||Standard Error|Least Squares Mean
1264433|NCT00402337|Secondary|Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period|Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid.|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis."|||units on a scale||Standard Error|Least Squares Mean
1264434|NCT00402337|Secondary|Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period|CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."|||CSBMs per week||Standard Error|Least Squares Mean
1264435|NCT00402337|Secondary|CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|"A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks.~For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate."|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."|||participants|||Number
1264436|NCT00402337|Secondary|SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|"A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks.~For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate."|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."|||participants|||Number
1264437|NCT00402337|Primary|Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency|Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.|Change from Baseline to Week 4|307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 “How many bowel movements did you have today or yesterday since your last call?” were included in the intent-to-treat (ITT) Population.|||SBMs per week||Standard Error|Least Squares Mean
1264438|NCT00402324|Secondary|Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)|Percentages of participants in each group who experienced an increase in weight of at least 7% from baseline to endpoint.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||percentage of participants|||Number
1264439|NCT00402324|Secondary|Clinically Significant Vital Signs - Weight Change From Baseline|Change from baseline to endpoint: Value of weight measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||kilograms||Standard Error|Least Squares Mean
1264440|NCT00402324|Secondary|Clinically Significant Vital Signs - Body Mass Index Change From Baseline|Change from baseline to endpoint in body mass index (an estimate of body fat derived by dividing body weight by height squared): Value of body mass index measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||kilograms per square meters||Standard Error|Least Squares Mean
1264441|NCT00402324|Secondary|Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline|Change from baseline to endpoint in bilirubin total: Value of bilirubin total measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||micromoles per Liter||Standard Deviation|Mean
1264442|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline|Change from baseline to endpoint in fasting blood glucose: Value of fasting blood glucose measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||milligrams per deciliter||Standard Deviation|Mean
1264443|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline|Change from baseline to endpoint in triglycerides: Value of triglyceride measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||milligrams per deciliter||Standard Deviation|Mean
1264444|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline|Change from Baseline to endpoint in cholesterol: value of cholesterol measure at endpoint minus the value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and at least one post-baseline measure. Intention to Treat analysis.|||milligrams per deciliter||Standard Deviation|Mean
1264447|NCT00402324|Secondary|Number of Participants Meeting the Criteria for Mixed Response|The original outcome measure was Time to Mixed Response(at least a 50% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.|baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||participants|||Number
1264448|NCT00402324|Secondary|Number of Participants Meeting the Criteria for Mixed Onset of Action|The original outcome measure was Time to Mixed Onset of Action (at least a 25% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||participants|||Number
1264449|NCT00402324|Primary|Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.|The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients with baseline & at least one post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1264450|NCT00402324|Primary|Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients with baseline & at least one post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1264451|NCT00402285|Primary|Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2|Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.|baseline through 3 month|1 ppt randomized to fish oil had un-evaluable COX-2 at 3 months.|||fold change||Standard Deviation|Mean
1264452|NCT00402246|Secondary|In-office Follow-up Burden: Hours Absent From Work Due to Visit|Subjects were asked at their one month visit to indicate on a survey how many hours of work they were missing to attend that visit.|1 month|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.|||Hours||Standard Deviation|Mean
1264453|NCT00402246|Secondary|In-office Follow-up Burden: Patient Expenses|On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.|1 month|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.|||Dollars||Standard Deviation|Mean
1264454|NCT00402246|Secondary|In-office Follow-up Burden: Distance Traveled|Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital.|1 month visit|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.|||Miles||Standard Deviation|Mean
1264455|NCT00402246|Secondary|Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).|Following the completion of enrollment in the study, participating clinicians were asked to complete a survey assessing their overall satisfaction with the wireless telemetry feature. Clinicians' rating (1=strongly disagree, 5=strongly agree) of the overall satisfaction with the wireless telemetry feature of the device|After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject|All surveys in which clinician completed at least a subset of the questions were included.|||Units on a scale||Standard Deviation|Mean
1264456|NCT00402246|Secondary|Trait-Anxiety Scale|The Trait-Anxiety scales for each subject were obtained at multiple time points. The Trait-Anxiety scale was derived by summing the 20 scores in the Trait section of the STAI questionnaire. The Trait-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).|1, 3, 6, 9, 12, and 15 months visits|All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1264457|NCT00402246|Secondary|State-Anxiety Scale|The State-Anxiety scales for each subject were obtained at multiple time points. The State-Anxiety scale was derived by summing the 20 scores in the State section of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).|1, 3, 6, 9, 12, and 15 month visit|All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1264458|NCT00402246|Secondary|Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)|"LV Capture Threshold is the required energy(volts) necessary to cause the left ventricule to contract. It is important that a device which paces the left ventricule be set to a threshold such that current conducted through the left ventricular lead will induce contraction in the left ventricle. However, these thresholds may vary over time.~The standard deviation and range (maximum LVCM threshold - minimum LVCM threshold) of the most recent 14 days of LVCM results prior to each follow-up visit were determined for each subject and used to assess within-patient variability in LV thresholds."|1, 3, 6, 9, 12, and 15 months visits|All enrolled subjects who were implanted with a Concerto CRT-D (Cardiac Resynchronization Therapy with Defibrillation)device, met inclusion/exclusion criteria, and had daily LVCM measurement for at least one of the 6 scheduled visits/transmissions were included in the analysis.|||Volts||Standard Deviation|Mean
1264475|NCT00402194|Primary|Leg Blood Flow Response to Insulin||3 months||||Liters/minute||Standard Deviation|Mean
1264532|NCT00401882|Secondary|Number of Precordial Shocks Required After the Administration of Metoprolol or Epinephrine||120 minutes|Data point not analyzed||||||
1264533|NCT00401882|Secondary|Adverse Effects||30 days||||Participants|||Count of Participants
1264459|NCT00402246|Secondary|CareLink Transmission Compliance|The CareLink Transmission Compliance Rate for a particular visit (e.g. 3 month visit) is the proportion (ranging from 0 to 1) of subjects with device interrogation data remotely transmitted via the CareLink system on the date it was scheduled to be sent for that visit. The proportion is a fraction in which the denominator is the number of subjects in the Remote Arm who were not exited from the trial prior to the visit of interest, and the numberator is the number of Remote Arm subjects who successfully transmitted device data via the CareLink system on the date it was scheduled to be sent.|3, 6, 9, 12 months visits|9 of 1014 remote arm subjects did not meet the inclusion/exclusion criteria and were excluded from the analysis. The remaining 1005 remote arm subjects were included in the analysis.|||Proportion of subjects||95% Confidence Interval|Mean
1264460|NCT00402246|Other Pre-specified|Length of Hospital Stay (LOS)|LOS per cardiovascular hospitalization|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who satisfied the inclusion/exclusion criteria and had at least one cardiovascular hospitalization were included in the analysis.|||Days||Standard Error|Mean
1264461|NCT00402246|Secondary|Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations|Days from device detection of a clinical event or a symptom-driven device interrogation event onset to a clinical decision, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event is an event as defined in the primary objective. A symptom-driven device interrogation event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.|From event onset to clinical decision|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.|||Days||Standard Deviation|Mean
1264462|NCT00402246|Secondary|Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations|Days from a symptom-driven device interrogation event onset to a clinical decision being made in response to the event as reported by the clinician. An event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.|||Days||Standard Deviation|Mean
1264463|NCT00402246|Secondary|AT/AF Alert Treatment|Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote patients who had at least one AT/AF alert were included in the analysis.|||Alerts|Participants||Number
1264464|NCT00402246|Secondary|Symptomatic AT/AF Alerts|AT/AF represents atrial tachycardia or atrial fibrillation which are arrhythmias involving rapid beating of the atrial chambers of the heart. The devices in this study store how many hours each day that a patient experiences AT/AF. The patient may not be aware they are experiencing these atrial arrhythmias, but if the AT/AF is accompanied by symptoms, the AT/AF is said to be symptomatic AT/AF. Devices in this study have an alert that fires if the patient experiences at least a programmed amount of AT/AF in a day. Measure is count of symptomatic AT/AF alerts as classified by the clinician|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote patients who experienced at least one AT/AF alert were included in the analysis. AT/AF alerts there were not classified by the clinician as symptomatic or asymptomatic were excluded from the analysis.|||Alerts|Participants||Number
1264465|NCT00402246|Secondary|Clinically Meaningful Alerts|Count of clinically meaningful alerts as classified by the clinician|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote subjects who experienced at least one alert were included in the analysis. Alerts that were not classified by the clinician as clinically meaningful or not were excluded from the analysis.|||Alerts|Participants||Number
1264466|NCT00402246|Secondary|Actions Taken for HCU Visits|Count of HCU visits that involved specific actions taken|Enrollment to last visit (up to 15 month post-implant)||||Visits|||Number
1264467|NCT00402246|Secondary|Health Care Utilization: TEEs|Count of Transesophageal echocardiograms (TEEs) performed|Enrollment to last visit (up to 15 months post-implant)|9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.|||Procedures|||Number
1264468|NCT00402246|Secondary|Health Care Utilization (HCU)|Count of HCU visits for each HCU type (cardiovascular (CV) hospitalizations, cardiovascular (CV) emergency department (ED), and cardiovascular (CV) unscheduled clinic office/urgent care visits)|Enrollment to last visit (up to 15 month post-implant)|9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.|||Visits|||Number
1264469|NCT00402246|Primary|Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues|Days from device detection of a clinical event to a decision being made in response to the event, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event could be any of the following that satisfied pre-specified thresholds: arrhythmias (e.g. at least 12 hours of atrial tachycard/atrial fibrillation in a day), cardiovascular disease progression (e.g. multiple device shocks delivered to terminate a single episode), or device issues (e.g. low battery).|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. An intention to treat analysis was performed for this objective.|||days||Inter-Quartile Range|Median
1264470|NCT00402233|Secondary|Beck Depression Inventory II|Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)|From baseline to week 12|Treated set|||units on a scale||Standard Deviation|Mean
1264471|NCT00402233|Secondary|Epworth Sleepiness Scale|Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)|From baseline to week 12|Treated set|||units on a scale||Standard Deviation|Mean
1264472|NCT00402233|Secondary|Modified Hoehn and Yahr Stage|Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)|From baseline to week 12|Treated set|||units on a scale||Standard Deviation|Mean
1264476|NCT00402168|Secondary|Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Day of Switch = the first belatacept infusion day.|Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study|All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized.|||participants|||Number
1264477|NCT00402168|Secondary|Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch|Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Day of Switch = the first belatacept infusion day.|Day of Switch (first belatacept dose) to Week 96 Post Switch|All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized. n=number of participants with data available at specific time point|||mL/min/1.73 m^2||Standard Deviation|Mean
1264478|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure|Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in mmHg. Baseline was value at screening. Only those participants who entered long term period were evaluated.|Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.|||mmHg||Standard Deviation|Mean
1264479|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure|Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was value at screening. Only those participants who entered long term period were evaluated.|Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.|||mmHg||Standard Deviation|Mean
1264480|NCT00402168|Secondary|Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period|Upper limits of normal (ULN). Hemoglobin: < 8 g/dL; Platelet count: < 50*10^9 c/L; Leukocytes: < 2.0*10^3 c/µL; Lymphocytes (absolute): < 0.5*10^3 c/µL; Neutrophils: < 1.0*10^3 c/µL; Alanine Aminotransferase (ALT): > 5.0*ULN Units per liter (U/L); bilirubin: > 3.0*ULN mg/dL; Creatinine: > 3.0*ULN mg/dL; Calcium: < 7 mg/dL; Bicarbonate: > 12.5 mg/dL; Potassium: < 3.0 meq/L or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL.|Baseline (Screening), up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.|||participants|||Number
1264481|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period|Baseline was value at screening. Serum creatinine was measured in mg/dL. Only participants who entered into Long Term Period were included in the analysis.|Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.|||mg/dL||Standard Deviation|Mean
1264482|NCT00402168|Secondary|Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections, Thrombolic/embolic events, Autoimmune Disease, Malignancy, Peri-infusional reactions (only belatacept treatment group was IV) , Acute Peri-infusional events occurring within 24 hours of injection, Pulmonary Edema and Congestive Heart Failure. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||participants|||Number
1264483|NCT00402168|Secondary|Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||participants|||Number
1264534|NCT00401882|Secondary|Survival to Hospital Discharge|the number of patients who are alive at hospital discharge|from time of arrest to discharge or death||||Participants|||Count of Participants
1264484|NCT00402168|Secondary|Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period|A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.|Baseline (screening) up to Month 36 post randomization|Participants without pre-randomization diabetes, who were randomized and entered LT Period.|||percentage of participants||95% Confidence Interval|Number
1264485|NCT00402168|Secondary|Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period|Graft loss = either pure graft loss (participant survived to the end of the study period after graft loss) or death with functioning graft. Pure graft loss = either functional loss or physical loss. Functional loss = a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation. The table was designed with built-in redundancy to capture all possible combinations of death and/or graft loss, but not all lines can be summed to reach the total number surviving and the total number who die and/or lose grafts. If a participant experiences pure graft loss and dies at a later date independent of the graft loss event, they are counted only once in the cumulative tabulation of death or graft loss. Only the first event experienced by the participant counted toward the cumulative total.|Post Months 24, 36, 48, up to Year 6 of the Study|Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||participants|||Number
1264486|NCT00402168|Secondary|Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period|AR was defined: if either a or b was satisfied: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 working classification of kidney transplant pathology was used to categorize the severity of the AR.|Post Month 12 up to Year 6 of the Study|Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||participants|||Number
1264487|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period|ITT=participants randomized to their original treatment arm and who entered the LT period are presented. Baseline=value at screening. Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value of 0 was imputed and carried forward after death or graft loss up to the end of the analysis period. Sponsor discontinued the CNI treatment arm in Year 3, and participants treated with CNI could elect to switch to belatacept. If a participant did not switch to belatacept, they were required to discontinue from the study. Therefore, efficacy results from Month 36 through Month 54 are difficult to interpret. No formal comparisons were planned between the belatacept and CNI treatment groups post Month 36, and the data up to the final database lock should be interpreted with caution.|Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54|Participants randomized to their original treatment arm who entered the LT Period (ITT - LT) and had data at baseline and at specific timepoints . Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||mL/min/1.73 m^2||Standard Deviation|Mean
1264488|NCT00402168|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants|Upper limits of normal (ULL). Leukocytes: < 2.0*10^3 cells per microliter (c/µL); Lymphocytes (absolute): < 0.5*10^3 c/µL; bilirubin: > 3.0*ULN milligrams per deciliter (mg/dL); Potassium: < 3.0 milliequivalents per liter (meq/L) or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL. Baseline = value at screening.|Baseline up to Month 12|All randomized participants who received at least one dose of study drug and had a laboratory value available post randomization. N= number of participants analyzed in all categories|||participants|||Number
1264489|NCT00402168|Secondary|Ridit Score at Month 12 - All Randomized Participants|The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at 12 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.|Month 12|All randomized participants with MTSOSD-59R data were analyzed.|||Ridit score|||Number
1264499|NCT00402168|Secondary|Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation.|At 6 and 12 months post randomization|All participants who were randomized were summarized.|||percentage of participants|||Number
1264490|NCT00402168|Secondary|Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants|"SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 8 domains of physical and mental component summaries: physical function, role limitations due to physical problems, pain, general health perception, and vitality, social function, role limitations due to emotional problems, and mental health.~All domains were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life."|Baseline (screening) to Month 12|Randomized participants with available questionnaires were analyzed.|||units on a scale||Standard Error|Mean
1264491|NCT00402168|Secondary|Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire. The subscale in the mental component (MCS) part of the instrument ranged from 1 to 6 with 1=all of the time and 6= none of the time. The subscale for physical component (PCS) ranged from 1 to 3 with 1=Yes, limited a lot and 3=No, not limited at all. The subscale for the extent that physical health or emotional problems interfered with normal activities ranged from 1 to 5 with 1=not at all and 5= extremely. Baseline was at randomization or prior to first dose. Baseline = value at screening. The subscale scores were transformed using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.|Baseline, Month 12|All randomized participants who completed the questionnaire at baseline and at Month 12.|||units on a scale||Standard Error|Mean
1264492|NCT00402168|Secondary|Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|First Dose (Day 1) to Month 12|All randomized participants who received at least 1 dose of study drug were summarized.|||participants|||Number
1264493|NCT00402168|Secondary|Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants|Baseline was value at screening or prior to first dose of study drug. Serum creatinine was measured in milligrams per deciliter (mg/dL). Baseline = value at screening.|Baseline to Month 6 and Month 12 Post Randomization|All randomized participants with baseline and laboratory value at specific time point were summarized.|||mg/dL||Standard Deviation|Mean
1264494|NCT00402168|Secondary|Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies|Samples were obtained at Day 1 (first dose), Week 24, and Week 52 (or end of therapy). This was a cumulative summary in that once a participant was positive, that participant remained positive for later time points. Evaluation of anti-donor HLA antibodies was performed by an external laboratory (Emory University, Atlanta, Georgia).|Month 6 and Month 12 Post Randomization|Participants who had at least one test result or finding were summarized. n=number of participants analyzed at each specific time point.|||participants|||Number
1264495|NCT00402168|Secondary|Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants|A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.|Month 12 post randomization|Participants without pre-randomization diabetes.|||percentage of participants||95% Confidence Interval|Number
1264496|NCT00402168|Secondary|Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12|Percentage=number with composite divided by number randomized. Graft loss was functional loss or physical loss. Functional loss = sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that participant undergoes re-transplantation. AR: if either a or b: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy-proven AR (grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy-proven AR, and the participant was treated for it.|12 Months post randomization|All participants who were randomized were analyzed.|||percentage of participants||95% Confidence Interval|Number
1264497|NCT00402168|Primary|Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)|Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on Day 1.|Baseline to 12 months post randomization|Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.|||mL/min/1.73 m^2||Standard Deviation|Mean
1264498|NCT00402168|Secondary|Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants|Reasons for study drug dose modification included categories of decline in renal function (as determined by the investigator), treatment of acute rejection, and other reasons. More than 1 reason could be given for dose alteration.|Month 12|Participants who were randomized and received at least one dose of any study drug.|||participants|||Number
1264535|NCT00401882|Primary|Return of Spontaneous Circulation|The patient will be evaluated for sufficiently stable and organized rhythm and blood pressure.|After electrical defibrillation||||Participants|||Count of Participants
1264500|NCT00402168|Secondary|Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants|AR defined: if either a or b was satisfied: a: the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification Grade IA or higher as assessed by the blinded central pathologist); b: the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection.|At 6 and 12 months post randomization|ITT population: All randomized participants were summarized. N=number analyzed for Months 6 and 12|||participants|||Number
1264501|NCT00402168|Secondary|Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)|Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening.|Baseline to 6 months post randomization|Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.|||mL/min/1.73 m^2||Standard Deviation|Mean
1264502|NCT00402103|Secondary|Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline, Week 2, Week 10, Week 28 and Week 54|Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.|||Percentage of patients|||Number
1264503|NCT00402103|Secondary|Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg||Baseline, Week 2, Week 10, Week 28 and Week 54|Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.|||Percentage of patients|||Number
1264504|NCT00402103|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points||Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54|Treated population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.|||mm Hg||Standard Deviation|Mean
1264505|NCT00402103|Primary|Overall Percentage of Patients With Adverse Events||52 weeks|Treated Population|||Percentage of Participants|||Number
1264506|NCT00402051|Secondary|Pharmacology Toxicities|Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.|Every 21-day cycle for up to 6 cycles|Full Analysis Set: All patients randomized who received at least one dose of study drug|||participants|||Number
1264507|NCT00402051|Secondary|Time to Treatment Failure (TTF)|Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first|Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)|Full Analysis Set: All patients randomized who received at least one dose of study drug|||months||95% Confidence Interval|Median
1264508|NCT00402051|Secondary|Number of Participants With Tumor Response (as Basis for Response Rate)|"Best overall response was evaluated using RECIST Criteria which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage."|Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression|Full Analysis Set: All patients randomized who received at least one dose of study drug|||participants|||Number
1264509|NCT00402051|Secondary|Overall Survival|Defined as the time from randomization to the date of death from any cause.|Randomization to date of death from any cause (up to 1 year)|Full Analysis Set: All patients randomized who received at least one dose of study drug|||months||95% Confidence Interval|Median
1264510|NCT00402051|Primary|Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)|For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.|Randomization to Month 6|Full Analysis Set: All patients randomized who received at least one dose of study drug|||percentage|||Number
1264525|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Total Cholesterol||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
1264561|NCT00401778|Primary|Inhibition of Proliferation (Ki67) and Induction of Apoptosis (TUNEL Assay) in Tumor Specimens and Buccal Mucosa.||6 months|||||||
1264511|NCT00402025|Secondary|Change From Baseline in Pain Intensity|Pain was assessed by the participant using a validated Visual Analog Scale (VAS) pain assessment instrument. A single 10-cm line was used with the leftmost end (0 cm) representing “no pain” and the rightmost end (10 cm) representing “worst pain”. The distance was measured from the leftmost part of the scale to the mark made by the participant indicating pain level.|Baseline and Weeks 3 and 6|ITT population with available VAS data; this assessment was added in the third protocol amendment and change from baseline could only be assessed for participants in cohort 3.|||cm||Standard Deviation|Mean
1264512|NCT00402025|Primary|Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies|Anti-HSV-1 antibodies were detected using an enzyme-linked immunosorbent assay (ELISA).|Week 0 (Day 1, predose) and Week 3|ITT population with available antibody results (indicated by N)|||participants|||Number
1264513|NCT00402025|Primary|Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine|Samples of blood and urine collected before and up to 24 hours after dosing were tested for the presence of talimogene laherparepvec deoxyribonucleic acid (DNA) using a validated quantitative polymerase chain reaction (qPCR) assay.|Treatment Day 1 predose and 2, 6, 12 and 24 hours postdose, and Week 3 and 6 at (predose and 2 hours postdose.|ITT population|||participants|||Number
1264514|NCT00402025|Secondary|Number of Participants With Overall Objective Response|"Tumor response was assessed via CT scan by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 guidelines. Objective response is defined as a complete response (CR) or partial response (PR).~CR: Disappearance of all target and non-target lesions, normalization of tumor marker level and no new lesions and with confirmation no less than 4 weeks after the criteria for CR is first met.~PR: At least a 30% decrease in the sum of longest diameters of target lesions taking as reference the baseline sum of the longest diameters, absence of non-target lesion progression, and no new lesions. These criteria must be confirmed no less than 4 weeks after they are first met."|Every 6 weeks until 12 weeks after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.|ITT population|||participants|||Number
1264515|NCT00402025|Secondary|Change From Baseline in Sum of Longest Diameters of Injected Tumors|Spiral computed tomography (CT) scans were performed to assess tumors at screening and at Weeks 6, 12 and 18 after the initial dose.|Baseline and Week 6, 12 and 18|"ITT population with available data at each time point (indicated by N)."|||mm||Standard Deviation|Mean
1264516|NCT00402025|Primary|Number of Participants With Adverse Events|A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.|From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.|ITT population|||participants|||Number
1264517|NCT00401973|Secondary|Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks|To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.|Baseline to endpoint (22 weeks)|N=Pairs of Observations for the combined treatment groups.|||correlation|||Number
1264518|NCT00401973|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.|||units on a scale||Standard Deviation|Mean
1264519|NCT00401973|Secondary|Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.|||units on a scale||Standard Deviation|Mean
1264520|NCT00401973|Secondary|Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score|The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.|||units on a scale||Standard Deviation|Mean
1264521|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Hemoglobin A1c||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||percent hemoglobin A1c||Standard Deviation|Mean
1264522|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Glucose||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
1264523|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
1264524|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol||Baseline to endpoint (22 weeks)|Number of randomized participants with a baseline and at least one post-baseline measurement. Last post-baseline measurement carried forward.|||millimole per liter (mmol/L)||Standard Deviation|Mean
1264536|NCT00401843|Primary|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|up to 5 years|The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received.|||participants|||Number
1264537|NCT00401843|Secondary|Overall Survival|Overall survival was defined as the interval between the first administration of study agent or randomization (Part 2) and the participant’s death from any cause. For participants with unknown survival status as of the data cut-off date, overall survival was censored at the last date known to be alive.|up to 5 years|ITT population included all participants randomized in Part 2. Participants were analyzed as per initial randomization.|||days||95% Confidence Interval|Median
1264538|NCT00401843|Secondary|Percentage of Participants With Confirmed Complete Response (CR Rate)|CR rate was defined as the percentage of participants who achieved a confirmed CR before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas.|Randomization until disease progression (maximum up to 5 years)|Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone.|||percentage of participants|||Number
1264539|NCT00401843|Secondary|Percentage of Participants With Best Confirmed Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate)|Overall response rate was defined as best response (CR/PR confirmed) for a participant recorded from first administration of study agent or randomization (Part 2) until disease progression/recurrence and before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas. PR: Greater than or equal to (>=) 50% reduction in level of serum M-protein, maintained for minimum of 6 weeks. Reduction in 24 hour urinary light chain excretion either by >= 90% or to < 200 mg, maintained for minimum of 6 weeks; >= 50% reduction in size of soft tissue plasmacytomas; No increase in size/number of lytic bone lesions.|Randomization until disease progression (maximum up to 5 years)|Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone.|||percentage of participants|||Number
1264540|NCT00401843|Primary|Progression-free Survival|Progression-free survival was defined as the time interval between randomization and the first documented sign of disease progression (including relapse from complete response [CR]) by the European Bone Marrow Transplant (EBMT) criteria or death, whichever occurred first. Relapse from CR requires at least 1 of the following: Reappearance of serum or urinary M-protein on immunofixation or routine electrophoresis, confirmed by at least 1 further investigation and excluding oligoclonal immune reconstitution; Greater than or equal to (>=) 5 percent (%) plasma cells either in a bone marrow aspirate or on trephine bone biopsy; Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression); Development of hypercalcemia not attributable to any other cause.|Randomization until disease progression or death, which ever occured first (maximum up to 5 years)|Intent-to-treat (ITT) population included all participants randomized in Part 2. Participants were analyzed as per initial randomization.|||days||95% Confidence Interval|Median
1264541|NCT00401830|Secondary|Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12||End of the Maintenance Phase/Week 12|The number of patients in the Placebo treatment group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 78 patients in the Lacosamide treatment group (Safety Set) data were available at the end of Maintenance Phase/Week 12 for the 45 patients remaining in the study.|||ug/ML||Standard Deviation|Mean
1264542|NCT00401830|Secondary|Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase|All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 61 and 60 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Score on a scale||Standard Deviation|Mean
1264543|NCT00401830|Secondary|Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase|Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).|12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.|||Percentage of patients|||Number
1264544|NCT00401830|Secondary|Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase|Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.|12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.|||Percentage of patients|||Number
1264585|NCT00401544|Secondary|Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose|Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.|||Participants|||Number
1264545|NCT00401830|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase|The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have change from Baseline data for depression. One subject in the Lacosamide group had a missing anxiety score.|||Score on a scale||Standard Deviation|Mean
1264546|NCT00401830|Secondary|Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase|The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have this assessment.|||Patients|||Number
1264547|NCT00401830|Secondary|Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12 week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1264548|NCT00401830|Secondary|Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12 week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1264549|NCT00401830|Secondary|Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase|General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1264550|NCT00401830|Secondary|Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase|Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1264551|NCT00401830|Secondary|Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase|Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Score on a scale||Standard Deviation|Mean
1264552|NCT00401830|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase|The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Score on a scale||Standard Deviation|Mean
1264553|NCT00401830|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.|||Score on a scale||Standard Deviation|Mean
1264554|NCT00401830|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
1264555|NCT00401817|Secondary|Overall Survival|"The percentage of patients who have survived at the three year time point.~The 3-year OS rate was estimated based on the Kaplan-Meier analysis."|3 years|Evaluable Patients|||percentage of patients||95% Confidence Interval|Number
1264556|NCT00401817|Secondary|Progression-Free Survival|"The percentage of patients who have not progressed at the three year time point.~The 3-year PFS rate was estimated based on the Kaplan-Meier analysis."|3 years|Evaluable patients|||percentage of patients||95% Confidence Interval|Number
1264557|NCT00401817|Secondary|Overall Response Rate|"Overall Response Rate measured using Kaplan-Meier survival analysis~Response criteria were those reported by Cheson et al. (1999)"|38 Months (min 33 months, max 62 months)|Evaluable patients|||percentage of participants||95% Confidence Interval|Number
1264558|NCT00401817|Primary|Number of Participants With Toxicity|Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|38 months||||participants|||Number
1264559|NCT00401778|Secondary|Duration of Hospital Stay Following Surgery.||6 months||||days||Full Range|Median
1264560|NCT00401778|Secondary|Safety and Tolerability of RAD001 as Pre-operative Therapy.||6 months|||||||
1264562|NCT00401778|Primary|Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).|Changes in the expression of key signaling proteins in the mTOR/phosphatidylinositol 3-kinase (PI3K) pathway were determined by immunohistochemistry using previously published protocols and manufacturers’ recommendations for antigen retrieval and antibody dilution along with positive and negative controls. Two investigators assessed protein expression jointly by light microscopy. The degree of expression was assessed by intensity (0, 1+, 2+, 3+) and percentage of cell staining in line with published algorithm. A derivative score (immunoscore) ranging between 0 and 300 was calculated as the product of intensity and percent cell staining.|6 months||||% change in immunoscore||Standard Deviation|Mean
1264563|NCT00401778|Primary|Clinical Response as Assessed Metabolically by Changes in Positron Emission Tomography (PET) Scan Between Baseline and Immediately Prior to Surgery.|All patients had baseline imaging in a fasted state with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18FDG)-PET scan and a repeat scan at 3 to 4 weeks later using routine clinical protocol for patient preparation, radiotracer administration and data acquisition. The repeat imaging occurred no longer than 24 hours before surgical resection.|Day 21||||percentage of patients|||Number
1264564|NCT00401752|Secondary|The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy|Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment.|4 & 8 weeks||||Percentage of participants|||Number
1264565|NCT00401752|Secondary|The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment.|4 and 8 week||||Percentage of participants|||Number
1264566|NCT00401752|Secondary|Percentage of Participants With the Occurance of Any Adverse Event.|Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment.|8 weeks|Patients included in safety population|||Percentage of participants|||Number
1264567|NCT00401752|Secondary|The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8.|week 4 and week 8||||Percentage of participants|||Number
1264568|NCT00401752|Secondary|The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment.|8 weeks||||Percentage of participants|||Number
1264569|NCT00401752|Primary|The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.|"Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment.~(Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent)."|4 weeks||||Percentage of participants|||Number
1264570|NCT00401726|Secondary|Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse).|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. Data not available for one participant.|||patients|||Number
1264571|NCT00401726|Secondary|Change in Sheehan Disability Scale Score From Baseline to 16 Weeks|The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
1264572|NCT00401726|Secondary|Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks|IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
1264573|NCT00401726|Secondary|Number of Patients Compliant With Therapy|Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of “Never miss” or “Sometimes miss”.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||participants|||Number
1264636|NCT00401193|Primary|Mean Reduction From Baseline in Menstrual Blood Loss (MBL)|reduction of menstrual blood loss in mL|Baseline MBL over 3 menstrual cycles|modified intent to treat population|||mL||Standard Deviation|Least Squares Mean
1264574|NCT00401726|Secondary|Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks|WHO 5-item Well Being Index (WHO-5) evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0=worst possible quality of life, 25=best possible quality of life). Change = 16 week adjusted mean WHO-5 score minus baseline.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
1264575|NCT00401726|Secondary|Patient Global Impression of Improvement (PGI-I) Score|PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
1264576|NCT00401726|Secondary|Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
1264577|NCT00401726|Primary|Number of Patients Responding “Very Satisfied” on Satisfaction With Depression Care Scale (SDCS)|Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). “Very satisfied” was defined as a score of greater than or equal to 8.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||participants|||Number
1264578|NCT00401622|Primary|To Assess the Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.||From baseline to 52 wks|The study was designed to give 84% power to detect a 0.5% difference in the change of A1C between both groups|||Percentage||Standard Error|Least Squares Mean
1264579|NCT00401622|Secondary|To Assess the Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.||52 wks||||mg/dL||Standard Deviation|Mean
1264580|NCT00401544|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage|Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.|Baseline and Week 16|Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.|||Units on a scale||Standard Deviation|Mean
1264581|NCT00401544|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose|Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.|Baseline and Week 16|Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.|||Units on a scale||Standard Deviation|Mean
1264582|NCT00401544|Secondary|Time to Hematopoietic Response, by IV Iron Usage|The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.|||Weeks||95% Confidence Interval|Median
1264583|NCT00401544|Secondary|Time to Hematopoietic Response, by Darbepoetin Alfa Dose|The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.|||Weeks||95% Confidence Interval|Median
1264584|NCT00401544|Secondary|Number of Participants With a Hematopoietic Response, by IV Iron Usage|Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.|||Participants|||Number
1264637|NCT00401102|Secondary|Multidimensional Anxiety Scale for Children||recently|||||||
1264638|NCT00401102|Secondary|Beck Depression Inventory||2 weeks|||||||
1264586|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study|Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 5 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, and who were eligible for an RBC transfusion at week 5.|||Participants|||Number
1264587|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage|The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 1 to Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.|||Participants|||Number
1264588|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose|The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 1 to Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.|||Participants|||Number
1264589|NCT00401544|Secondary|Change From Baseline in Hemoglobin Concentration, by IV Iron Usage|Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).|Baseline and Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.|||g/dL||Standard Deviation|Mean
1264590|NCT00401544|Secondary|Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose|Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).|Baseline and Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.|||g/dL||Standard Deviation|Mean
1264591|NCT00401544|Secondary|Time to Achieve the Target Hemoglobin Level, by IV Iron Usage|The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.|||Weeks||95% Confidence Interval|Median
1264592|NCT00401544|Secondary|Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose|The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.|||Weeks||95% Confidence Interval|Median
1264593|NCT00401544|Primary|Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage|Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.|||Participants|||Number
1264594|NCT00401544|Primary|Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose|Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.|||Participants|||Number
1264595|NCT00401531|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|"Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.~Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited reactions were assessed in all participants that were enrolled and vaccinated, intent-to-treat population.|||Participants|||Number
1264596|NCT00401531|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.|Day 150 post-dose 1|Antibody titers were assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1264597|NCT00401531|Secondary|Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.|Day 150 post-dose 1|Seroconversion was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation per-protocol population.|||Participants|||Number
1264598|NCT00401531|Secondary|Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil|Day 150 post-dose 1|Seroprotection was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.|||Participants|||Number
1264599|NCT00401531|Secondary|Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.|Day 150 post-dose 1|Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria valuation, per-protocol population.|||Participants|||Number
1264600|NCT00401531|Primary|Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.|Day 150 post-dose 1|Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.|||Participants|||Number
1264601|NCT00401414|Secondary|Proportion of Patients With Serious Adverse Clinical Events.|Defined as an INR>4.0, use of vitamin K, major bleeding events (as defined by the Thrombolysis in Myocardial Infarction [TIMI] criteria), thromboembolic events, stroke (all cause), myocardial infarction, and death (all cause).|90 Days||||participants|||Number
1264602|NCT00401414|Secondary|Time to Stable Anticoagulation (in Days).|Defined as two consecutive INRs within the therapeutic range >7 days apart and with no dose change during this time.|90 Days||||Days||Standard Deviation|Mean
1264603|NCT00401414|Secondary|Per-patient Percentage of INRs Out of the Therapeutic Range|The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2|90 Days||||percentage of INRs out of range||Standard Deviation|Mean
1264604|NCT00401414|Secondary|Time to the First Therapeutic INR.|The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2|90 Days||||Days||Standard Deviation|Mean
1264605|NCT00401414|Primary|Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al).|"Primary end point: mean percentage of time INR is within therapeutic range. Though target INR was 2.0-3.0, therapeutic INR is considered 1.8-3.2 (allows for INR measurement error and avoids problems inherent in overcorrection).~The international normalized ratio (INR) is one way of presenting prothrombin time test results for people taking the blood-thinning medication warfarin. The INR formula adjusts for variation in laboratory testing methods so that test results can be comparable."|90 Days||||percentage of time||Standard Deviation|Mean
1264606|NCT00401401|Secondary|Best Overall Tumor Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years||||Participants|||Number
1264607|NCT00401401|Secondary|Time to Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years|Number of months between date of first infusion and date of best response|||months||Full Range|Median
1264608|NCT00401401|Secondary|Overall Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years||||Participants|||Number
1264609|NCT00401401|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.|Overall Study||||participants|||Number
1264610|NCT00401258|Secondary|Sheehan Disability Scale|"The Sheehan Disability Scale is a brief, 5-item self-report tool that assess functional impairment in work/school, social life, and family life. Scores range from 0-10 in each subset, with 0 being unimpaired and 10 being highly impaired.~The primary analysis of this scale was an endpoint analysis of the change from baseline."|At baseline and week 12||||units on a scale||95% Confidence Interval|Mean
1264611|NCT00401258|Secondary|Irritable Bowel Syndrome-Quality of Life Scale|"The Irritable Bowel Syndrome (IBS) Quality of Life Scale is a self-report quality of life measure specific to Irritable Bowel Syndrome that can be used to assess the impact of IBS and its treatment. There are 34 items summed and averaged for a total score between 0-100, with higher scores indicating better IBS specific quality of life.~Each item measures one of eight sub scales - dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationships - and is rated on a scale of 1-5 indicating how much the subject agrees with the statement (1 is no agreement, 5 is extreme agreement).~The primary analysis of this scale was an endpoint analysis of the change from baseline."|At baseline and week 12||||units on a scale||95% Confidence Interval|Mean
1264612|NCT00401258|Secondary|Hamilton Anxiety Rating Scale|"The Hamilton Anxiety Rating Scale is a clinician-administered scale designed to assess the severity of symptoms of anxiety. There are 14 items, scored on a scale of 0 (not present) to 4 (severe). The total score range is 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.~The primary analysis of this scale was an endpoint analysis of the change from baseline."|At baseline and week 12||||units on a scale||95% Confidence Interval|Mean
1264639|NCT00401102|Primary|Self-injury Monitoring Card||1 month|||||||
1265638|NCT00394654|Secondary|Time to Observed Maximum Sputum Concentration (Tmax)|Tmax of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528|||Day||Geometric Coefficient of Variation|Geometric Mean
1264613|NCT00401258|Secondary|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale is a clinician-rated scale consisting of 17 questions designed to assess depressive symptoms. Scores of 0-7 are considered normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression. 52 is the maximum score.|At first visit only||||units on a scale||Standard Deviation|Mean
1264614|NCT00401258|Secondary|Clinical Global Impression Scale|"The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12."|At each visit||||units on a scale||95% Confidence Interval|Mean
1264615|NCT00401258|Secondary|Short Form McGill Pain Questionnaire|"The Short Form McGill Pain Questionnaire is a self-administered questionnaire that measures pain intensity experienced by the patient. Scores on 15 descriptors are rated on an intensity scale of 0-3 (with 0 being no pain to 3 being severe pain), and has an overall score of between 0-45, with 0 being no pain and 45 being worst possible pain.~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12."|At each visit||||units on a scale||95% Confidence Interval|Mean
1264616|NCT00401258|Secondary|Brief Pain Inventory|"The Brief Pain Inventory is a self-administered questionnaire used to evaluate the severity of a patient's pain and its interference with their life.~Four items measure pain severity on a scale of 0-10, with 0 being absence of pain and 10 being severe pain. Seven items measure pain interference on a scale of 0-10, with 0 being absence of interference and 10 being severe interference.~The sub scale of both sub scores ranges 0-40, with 0 indicating no pain/interference and 40 indicating severe pain/interference.~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12."|At each visit||||units on a scale||95% Confidence Interval|Mean
1264617|NCT00401258|Primary|Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).|Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.|baseline and week 12||||Units on a scale||95% Confidence Interval|Mean
1264618|NCT00401245|Other Pre-specified|Gender of the Participants in Tapering Phase|Participants were re-randomized to tapering phase after OL phase.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.|||Participants|||Number
1264619|NCT00401245|Other Pre-specified|Mean Age of the Participants in Tapering Phase|Participants were re-randomized to tapering phase after OL phase.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.|||Years||Standard Deviation|Mean
1264620|NCT00401245|Secondary|Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16|MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.|Baseline, Week 4, Week 8, Week 12 and Week 16|The OL population included all participants who had taken at least 1 dose of open label test article. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||Units on a scale||Standard Deviation|Mean
1264621|NCT00401245|Secondary|Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score|MS-TSQ is a questionnaire assessing participants’ degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).|Week 16|The OL population included all participants who had taken at least 1 dose of open label test article. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
1264622|NCT00401245|Secondary|Number of Participants Showing Satisfaction With Tolerability at the End of Tapering|Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants’ response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Participants|||Number
1264623|NCT00401245|Secondary|Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment|Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants’ response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.|Week 1 and Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||Participants|||Number
1264624|NCT00401245|Secondary|Number of Participants With Each DESS One Week After End of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Participants|||Number
1264625|NCT00401245|Secondary|Number of Participants With Each DESS at the End of Second Week of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 18|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Participants|||Number
1264626|NCT00401245|Secondary|Number of Participants With Each DESS at the End of First Week of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.|||Participants|||Number
1264627|NCT00401245|Secondary|Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.|||Percentage of participants|||Number
1264628|NCT00401245|Secondary|Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.|||Participants|||Number
1264629|NCT00401245|Primary|DESS Total Score at 1 Week After the End of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
1264630|NCT00401245|Primary|DESS Total Score at End of Second Week of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 18|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
1264631|NCT00401245|Primary|Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.|||Units on a scale||Standard Deviation|Mean
1264632|NCT00401245|Primary|Number of Participants With Nausea During the First 2 Weeks of Treatment|Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.|||Participants|||Number
1264633|NCT00401193|Secondary|Responder Analysis - Reduction in Large Stains|Percentage of subjects who experienced a reduction from baseline in the frequency of large stains|Baseline over 3 mentrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||percentage of participants|||Number
1264634|NCT00401193|Secondary|Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding|A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Baseline scores over 3 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||units on a scale||Standard Deviation|Least Squares Mean
1264635|NCT00401193|Secondary|Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding|A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Baseline scores over 3 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||units on a scale||Standard Deviation|Least Squares Mean
1264640|NCT00401102|Primary|Self-Injurious Thoughts and Behaviors Interview||8 weeks|Data for all subjects who completed the study was examined - however because this was a small pilot study and only 5 subjects completed treatment, no statistical tests were completed.|||episodes of self-injury past month||Standard Deviation|Mean
1264641|NCT00401102|Primary|CDRS||1 week|||||||
1264642|NCT00401102|Primary|C-GAS||1 month|||||||
1264643|NCT00401102|Primary|CGI||1 week|||||||
1264644|NCT00400985|Primary|Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.||34 days post device implant to 6 months||||hospitalization|||Number
1264645|NCT00400946|Secondary|5-year Disease-Free Survival by CNS Directed Treatment Group|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of patients who achieved an induction complete remission with an evaluable sample at diagnosis for analysis of CNS-directed therapy .|||probability||95% Confidence Interval|Number
1264646|NCT00400946|Secondary|5-Year Disease-Free Survival by Bone Marrow Day 18 Status|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of patients who achieved an induction complete remission with an evaluable sample at day 18 (optional submission) for analysis of marrow morphology.|||probability||95% Confidence Interval|Number
1264647|NCT00400946|Secondary|5-Year Disease-Free Survival by MRD Day 32 Status|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of B cell ALL patients who achieved an induction complete remission with an evaluable sample at day 32 for analysis of MRD.|||probability||95% Confidence Interval|Number
1264648|NCT00400946|Secondary|Induction Therapeutic Nadir Serum Asparaginase Activity Rate|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL at a given timepoint.|Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective induction assessment timepoints.|||percentage of participants|||Number
1264649|NCT00400946|Secondary|Induction Serum Asparaginase Activity Level|Serum asparaginase activity (NSAA) levels were estimated based on established methods.|Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective induction assessment timepoints.|||IU/mL||Inter-Quartile Range|Median
1264650|NCT00400946|Secondary|Induction Infection Toxicity Rate|Infection toxicity rate is defined as the percentage of patients who experience bacterial or fungal infection of grade 3 or higher with treatment attribution of possibly, probably or definite based on CTCAEv3 during remission induction phase of combination chemotherapy.|Assessed daily during remission induction days 4-32.|The analysis dataset is comprised of eligible and treated patients. This excludes the 6 enrolled but ineligible patients. Rates in this overall study cohort will be compared against historical controls (in particular patients treated with a more intensive induction regimen).|||percentage of participants||95% Confidence Interval|Number
1264664|NCT00400803|Primary|Time to Progression|Time to progression (progression free survival)is defined as the time from the start of treatment until first documented sign of disease progression or death due to any cause. For subjects who do not progress, time to progression will be censored at the time of last tumor assessment.|From Enrollment Through 2 Years||||Months||Standard Error|Mean
1264651|NCT00400946|Secondary|Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Post-Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL ever during post-induction therapy.|Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.|The analysis dataset is comprised of all randomized patients who consented to research studies with a one post-induction evaluable sample for analysis of serum asparaginase activity.|||percentage of participants||95% Confidence Interval|Number
1264652|NCT00400946|Secondary|Post-Induction Nadir Serum Asparaginase Activity Level|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods.|Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective post-induction assessment timepoints.|||IU/mL||Standard Deviation|Mean
1264653|NCT00400946|Secondary|5-Year Disease-Free Survival|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of all randomized patients.|||probability||95% Confidence Interval|Number
1264654|NCT00400946|Primary|Asparaginase-Related Toxicity Rate|Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on CTCAEv3.|30-week post-induction asparaginase treatment period|The analysis dataset is comprised of all randomized patients.|||percentage of participants||95% Confidence Interval|Number
1264655|NCT00400881|Secondary|Duration of Mechanical Ventilation|Duration in days from day of intubation to day of extubation.|days|Analysis per protocol. All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.|||days||Standard Deviation|Mean
1264656|NCT00400881|Primary|Duration of Weaning Time|Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.|days|All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.|||days||Standard Deviation|Mean
1264657|NCT00400829|Secondary|Progression Free Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From start of treatment to the time of documented progression, assessed up to 5 years||||Months||95% Confidence Interval|Median
1264658|NCT00400829|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From start of treatment to death from any cause, assessed up to 5 years||||Months||95% Confidence Interval|Median
1264659|NCT00400829|Primary|Objective Response Rate (CR or PR) According to RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Tumor measurements repeated every 6 weeks||||percentage of patients responding|||Number
1264660|NCT00400803|Secondary|Time to Best Response|Time to best response is defined as the time from the start of treatment until first documented evidence of tumor response (30% decrease or complete disappearance of tumor). For subjects who do not show a tumor response, the time will be censored at the time of last contact.|From Enrollment to First Tumor Response||||Days||Full Range|Median
1264661|NCT00400803|Secondary|Overall Survival Time|Overall survival is defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.|Baseline to Death||||Months||Standard Error|Mean
1264662|NCT00400803|Secondary|Duration of Response|For subjects who show a response, duration of response is defined to be the time from first documented evidence of response(30% decrease or complete disappearance of tumor) until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment.|From Enrollment through Date of First Documented Disease Progression or Date of Death From Any Cause, Whichever Came First, Up to 100 Months||||Days||Full Range|Median
1264663|NCT00400803|Secondary|Best Overall Response by Cycle|Number of patients and their best response recorded from the state of treatment until disease progression. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response-disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|After Cycle 4, Cycle 6 and Cycle 7 of Therapy|For subjects who show a response, duration of response is defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment. 5 patients = missing data.|||Participants|||Number
1265639|NCT00394654|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Day||Geometric Coefficient of Variation|Geometric Mean
1264665|NCT00400764|Primary|Mean Serum Concentration of Dulanermin|The dulanermin serum concentration was measured using enzyme linked immunosorbent assay (ELISA).|Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1.|Safety-evaluable population|||µg/ml||Standard Deviation|Mean
1264666|NCT00400764|Primary|Number of Participants With a Clinically Significant Laboratory Abnormality|Laboratory Parameters were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). A clinically significant abnormality was defined as a Grade 3 (severe) or Grade 4 (very severe, life threatening, or disabling) laboratory toxicity according to the NCI CTCAE v3.0.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms).|Safety Evaluable population consisting of all randomized patients who received at least one dose of study drug.|||participants|||Number
1264667|NCT00400764|Primary|Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit|Body temperature was measured at baseline and throughout the study. Change from baseline was calculated using the patients last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||degrees Celsius||Standard Deviation|Mean
1264668|NCT00400764|Secondary|Phase II: Duration of Response as Assessed by the Investigator|"An event was defined as documented disease progression or death on study, whichever occurred first. Duration of objective response was defined only for patients with an objective response as determined by the investigator and was the time from the initial response to disease progression or death on study.~Kaplan−Meier methods were used to estimate median, percentiles, and range of duration of response."|From Baseline through Study Termination (up to approximately 33 months)|Safety-evaluable patients with an objective response determined by the Investigator.|||months||95% Confidence Interval|Median
1264669|NCT00400764|Secondary|Phase II: Objective Response as Assessed by the Investigator|Objective response was defined as a confirmed or unconfirmed complete response(CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. Patients without a post-baseline tumor assessment were considered non-responders.|From Baseline through Study Termination (up to approximately 33 months)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||participants|||Number
1264670|NCT00400764|Secondary|Phase II: Overall Survival|Median overall survival could not be estimated because of the low number of deaths at the time of study termination.|From Baseline through Study Termination (up to approximately 33 months)||||months||95% Confidence Interval|Median
1264671|NCT00400764|Secondary|Phase II: Progression Free Survival|Progression free survival (PFS) was defined as the time from randomization to documented disease progression or death, whichever occurred first and was based on the investigator's assessment using the modified IWG criteria. Kaplan−Meier methods were used to estimate median time to PFS. Data for patients without disease progression or death on study were censored at the time of the last tumor assessment.|From Baseline through Study Termination (up to approximately 33 months)|Safety-Evaluable population consisting of all randomized patients who received at least one dose of study treatment|||months||95% Confidence Interval|Median
1264672|NCT00400764|Primary|Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit|Heart rate was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||beats/minute||Standard Deviation|Mean
1264673|NCT00400764|Primary|Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit|Blood pressure was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||mmHg||Standard Deviation|Mean
1264674|NCT00400764|Primary|Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)|"Objective response was defined as a confirmed or unconfirmed complete response (CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. All radiographic and clinical data for the evaluation of objective response were submitted to an IRF for blinded and impartial assessment.~Patients without a post-baseline tumor assessment were considered non-responders."|From Baseline through Study Termination (up to approximately 33 months)|The phase II Efficacy-Evaluable population consisted of all randomized patients who received at least one dose of study treatment and had measurable disease at baseline, as assessed by the IRF.|||participants|||Number
1264675|NCT00400764|Primary|Number of Participants With Treatment-Emergent Adverse Events by Severity Grade|Safety was assessed through summaries of treatment-emergent adverse events (AEs); AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, according to the following guidelines: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Life-threatening or disabling) and Grade 5 (Death related to AE).|From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||participants|||Number
1264691|NCT00400569|Secondary|Participants' Progression Free Survival (PFS)|Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).|From On Treatment to Off Study - average of 6 months|All participants who completed the study|||months||95% Confidence Interval|Median
1264676|NCT00400764|Primary|Phase Ib: Number of Participants With a Dose-limiting Toxicity|A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD).|The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28).|The DLT-evaluable population consisted of all patients enrolled in the Phase Ib who received at least two complete cycles of dulanermin and four doses of rituximab and complete study assessments through the DLT Assessment Window without a DLT (usually through Day 28) or experienced a DLT and withdrew from the study within the DLT Assessment Window.|||participants|||Number
1264677|NCT00400712|Primary|Subjective Index of Physical Integration (Subscale of SIPSO)|see 'Subjective Index of Physical and Social Outcome (SIPSO) above|baseline and one year|those who completed 1 year testing|||points on a scale||Standard Deviation|Mean
1264678|NCT00400712|Primary|Subjective Index of Social Integration (Subscale of SIPSO)|see Subjective Index of Physical and Social Outcome (SIPSO) above|baseline and one year|those who completed 1 year testing|||points on a scale||Standard Deviation|Mean
1264679|NCT00400712|Secondary|Health-related Quality of Life - Mental|The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest.|baseline and one year|those enrolled at 1 year (primary endpoint)|||points||Standard Deviation|Mean
1264680|NCT00400712|Secondary|Health-related Quality of Life - Physical|The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best.|baseline and one year|those enrolled at primary endpoint (one year)|||points||Standard Deviation|Mean
1264681|NCT00400712|Secondary|Physical Capacity|6 minute walk test (6MWT). Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.|baseline and 12 months|all those enrolled at primary endpoint - 1 year|||meters||Standard Deviation|Mean
1264682|NCT00400712|Secondary|Mobility Function|Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds)|baseline and 1 year|those still enrolled at primary endpoint (one year)|||seconds||Standard Deviation|Mean
1264683|NCT00400712|Primary|Subjective Index of Physical and Social Outcome (SIPSO)|The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration.|baseline and 1 year|those who completed 1 year testing|||scores on a scale||Standard Deviation|Mean
1264684|NCT00400686|Primary|Number of Patients With an at Least 2gm/dL Increase in Hgb||Baseline to Day 28||||participants|||Number
1264685|NCT00400686|Primary|Number of Patients With an at Least 1gm/dL Increase in Hgb||Baseline to Day 28||||participants|||Number
1264686|NCT00400686|Primary|Change From Baseline in Hemoglobin at Day 28|Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.|Baseline to Day 28||||g/dL||Full Range|Median
1264687|NCT00400634|Other Pre-specified|UPDRS Part III OFF|"The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined off condition, 12 hours or more after the last administration of medication."|Change from Baseline to 18 Month Visit|Subjects who completed the 12-month double-blind posttreatment period of the study continued to undergo double-blind assessments every 3 months until the last subject had completed the end-of-study visit at month 12. The LOCF method was used to impute data at month 18 for the subjects who had blinded data through month 15.|||units on a scale||Standard Error|Least Squares Mean
1264688|NCT00400634|Primary|UPDRS Part III OFF|"The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined off condition, 12 hours or more after the last administration of medication."|Change from Baseline to 12 Month Visit|Subjects who completed the end-of-study visit at month 12 and had no important protocol deviations that potentially could have affected the efficacy assessment of the study drug.|||units on a scale||95% Confidence Interval|Least Squares Mean
1264689|NCT00400569|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.|4 years, 7 months|All Participants|||participants|||Number
1264690|NCT00400569|Secondary|Participants' Overall Survival (OS)|The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.|From On Treatment to Off Study - average of 6 months|All participants who completed the study|||months||95% Confidence Interval|Median
1295888|NCT00075816|Primary|Two-year Overall Survival|Overall survival rate at 2 years according to an intention-to-treat analysis.|Measured at 2 years||||percentage of patients||95% Confidence Interval|Number
1264692|NCT00400569|Primary|Number of Participants With Overall Response (OR)|Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).|From On Treatment to Off Study - average of 6 months|All participants assessable for response|||participants|||Number
1264693|NCT00400517|Primary|Time to Clinical Progression|Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.|32 months||||Participants|||Count of Participants
1264694|NCT00400517|Primary|Prostate-specific Antigen Response|Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.|8 weeks||||Participants|||Count of Participants
1264695|NCT00400517|Primary|Proportion of Patients With Negative Surgical Margins|Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.|8 Weeks||||Participants|||Count of Participants
1264696|NCT00400517|Primary|Proportion of Patients P0 at Surgery|Pathologic Complete Response is defined as complete eradication of tumor.|8 weeks||||Participants|||Count of Participants
1264697|NCT00400400|Secondary|Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores|The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) that are rated on a 5-point scale from 0 to 4. The individual scores are summed to produce a total score of the 36 items for a total possible score of 0 to 144. Lower scores represent greater dysfunction.|Baseline, Day 30|"Participants from the Intention-to-treat (ITT) population consisting of all randomized participants who received at least one dose of study drug for whom data was available for analysis. n in each of the categories is the number of participants with data available."|||Score on a scale||Standard Deviation|Mean
1264698|NCT00400400|Secondary|Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment|The GSRS has five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion) producing a mean subscale score ranging from 1 (=no discomfort at all) to 7 (very severe discomfort). The mean score at baseline (BL), the mean score at Day 30 and the mean Change from BL to Day 30 is presented for each of the five subscales.|Baseline to Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.|||Score on a scale||Standard Deviation|Mean
1264699|NCT00400400|Secondary|Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score|This is reflected by the total score. The total score incorporates lower and upper GI elements. GSRS overall score is the mean of 15 individual GI symptom scores, each rated on a 7- point scale: 1 = no discomfort, 2= minor discomfort, 3 = mild discomfort, 4 = moderate discomfort, 5 = moderately sever discomfort, 6 = severe discomfort and 7 = very severe discomfort. Change from Baseline was calculated using ANCOVA, model includes GSRS, center and treatment group.|Baseline, Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.|||change in score on a scale||Standard Deviation|Mean
1264700|NCT00400400|Secondary|Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment|The number of participants with reported dose changes or interruption of study medication during the 30 days of treatment.The most common dose adjustments were dose increases back to baseline levels following a decrease or interruption and decreases due to abnormal laboratory value Adverse Events (leucopenia, thrombocytopenia, neutropenia, or anemia).|30 days|Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1264701|NCT00400400|Secondary|Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score|The Severity Score for each GI symptom for each participant was calculated based on the physician's evaluation of current GI symptoms recorded at Baseline and Day 30. For each of the 16 individual GI symptoms the severity score ranged from 0 (absent) to 3 (severe). The Overall Total Score is the Mean of severity ratings of the 16 individual symptoms.|Baseline, Day 30|"Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. n in each of the categories is the number of participants with data."|||Score on a scale||Standard Deviation|Mean
1264702|NCT00400400|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)|"TAR was defined as an episode of acute rejection that was suspected on clinical grounds and was treated and confirmed by the investigator according to the patient's response to therapy.~BPAR was defined a treated acute rejection that was confirmed by biopsy. A graft core biopsy was performed before or within 24 hours of initiation of anti-rejection therapy and was assessed by the pathologist at the center according to the BANFF 1997 criteria."|30 days|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1264703|NCT00400400|Primary|The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy|Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7.|Baseline, Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.|||Participants|||Number
1264719|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264704|NCT00400205|Secondary|Tumor Change by Baseline Acetylated Tubulin Expression Score|"Percent change in TNM stage of tumors after three cycles of study treatment was assessed to see if baseline acetylated tubulin (AT) expression predicts treatment success. Decreasing tumor stage change (a negative number) indicates that the tumor is responding to treatment while an increase means that the severity of the tumor is not decreasing. Immunohistochemistry (IHC) analysis of AT expression was performed in formalin-fixed, paraffin-embedded, pre-treatment tissues. The staining was scored based upon intensity according to the following criteria: 0=no staining, 1+=weak tumor staining, 2+=moderate tumor staining, 3+=moderate to high tumor staining, and 4+=high tumor staining.~Data presented are adopted from Saba, NF, et. al. Acetylated Tubulin (AT) as a Prognostic Marker in Squamous Cell Carcinoma of the Head and Neck. Head and Neck Pathology (2014) 8:66-72."|Baseline, After 3 cycles of study treatment|Participants who completed the study are included in this analysis.|||percentage of tumor stage change||Standard Deviation|Mean
1264705|NCT00400205|Primary|Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)|Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].|every 3 months||||participants|||Number
1264706|NCT00400179|Primary|Median Survival|Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.|The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).||||Months||95% Confidence Interval|Median
1264707|NCT00400179|Secondary|Time to Treatment Failure (TTF)|The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first.|From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.||||Months||95% Confidence Interval|Median
1264708|NCT00400179|Secondary|Progression-free Survival (PFS)|The time from randomization to date of first documented PD or date of death, whichever occurred first.|From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.||||Months||95% Confidence Interval|Median
1264709|NCT00400179|Secondary|Duration of Response (DR)|Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions.|Data cutoff was 07 March 2008 (12 months after last patient was randomized).||||Months||95% Confidence Interval|Median
1264710|NCT00400179|Secondary|Overall Response Rate (ORR)|The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions.|Data cutoff was 07 March 2008 (12 months after last patient randomized).||||Percentage of patients in each group||95% Confidence Interval|Number
1264711|NCT00400153|Secondary|Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours|Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−6, ss|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||μg||Geometric Coefficient of Variation|Geometric Mean
1264712|NCT00400153|Secondary|Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours|Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0−6,ss|Before drug administration to 6 hours after drug administration on Day 26|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||μg||Geometric Coefficient of Variation|Geometric Mean
1264713|NCT00400153|Secondary|Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours|Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−2,ss.|Before drug administration to 2 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||μg||Geometric Coefficient of Variation|Geometric Mean
1264714|NCT00400153|Secondary|Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours|Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss|Before drug administration to 2 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||μg||Geometric Coefficient of Variation|Geometric Mean
1264715|NCT00400153|Secondary|Noncompartmental Parameters of Albuterol at Steady State|Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1264716|NCT00400153|Secondary|Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State|Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1264717|NCT00400153|Secondary|Rating of Action of Turning Clear Base of Respimat|Frequency of patients due to rating of action of turning clear base of Respimat|12 weeks|Treated set (US patients)|||participants|||Number
1264718|NCT00400153|Secondary|Device Preference (Respimat or MDI)|Frequency of patients due to device preference|12 weeks|Treated set (US patients)|||participants|||Number
1264832|NCT00399542|Secondary|Month 2 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264720|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264721|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264722|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264723|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264724|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264725|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264726|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264727|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264728|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
1264729|NCT00400153|Secondary|Frequency Distribution of Satisfaction Rating With Inhaler Attributes||12 weeks|Treated set (US patients)|||participants|||Number
1264730|NCT00400153|Secondary|COPD Exacerbation During the On-treatment Period|COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set|||Percentage of patients|||Number
1264731|NCT00400153|Secondary|COPD Exacerbation Rate During the On-treatment Period|Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set|||Proportion of patients|||Number
1264732|NCT00400153|Secondary|Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period|COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set|||Percentage of patients|||Number
1264733|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 85|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 85|Treated Set|||units on a scale||Standard Error|Least Squares Mean
1264734|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 57|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 57|Treated Set|||units on a scale||Standard Error|Least Squares Mean
1264735|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 29|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 29|Treated Set|||units on a scale||Standard Error|Least Squares Mean
1264736|NCT00400153|Secondary|Trough Peak Expiratory Flow Rate (PEFR)|The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication|Full Analysis Set for Diary Data|||liters/min||Standard Error|Least Squares Mean
1264737|NCT00400153|Secondary|Daytime Symptom Score|"The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period).~Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities"|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data|||units on a scale||Standard Error|Least Squares Mean
1264738|NCT00400153|Secondary|Night-time Symptom Score|"The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period).~Night−time COPD symptoms: 0=none 1=some − slept well 2=woke once 3=woke several times 4=woke most of night"|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data|||units on a scale||Standard Error|Least Squares Mean
1264739|NCT00400153|Secondary|Daytime Rescue Medication Use|The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data|||puffs||Standard Error|Least Squares Mean
1264740|NCT00400153|Secondary|Night-time Rescue Medication Use|The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data|||puffs||Standard Error|Least Squares Mean
1264741|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 85|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85|During the 6-hour pulmonary function testing after drug administration on Day 85|Treated Set|||patients|||Number
1264742|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 57|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57|During the 6-hour pulmonary function testing after drug administration on Day 57|Treated Set|||patients|||Number
1264743|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 29|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29|During the 6-hour pulmonary function testing after drug administration on Day 29|Treated Set|||patients|||Number
1264744|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 1|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1|During the 6-hour pulmonary function testing after drug administration on Day 1|Treated Set|||patients|||Number
1264745|NCT00400153|Secondary|Peak FVC Response at Day 85|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264746|NCT00400153|Secondary|Peak FVC Response at Day 57|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264747|NCT00400153|Secondary|Peak FVC Response at Day 29|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264748|NCT00400153|Secondary|Peak FVC Response at Day 1|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264749|NCT00400153|Secondary|Peak FVC Response at Day 85|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264750|NCT00400153|Secondary|Peak FVC Response at Day 57|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264751|NCT00400153|Secondary|Peak FVC Response at Day 29|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264752|NCT00400153|Secondary|Peak FVC Response at Day 1|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264753|NCT00400153|Secondary|FVC AUC4-6 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85|Between 4 hours and 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
1264754|NCT00400153|Secondary|FVC AUC4-6 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57|Between 4 hours and 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
1264755|NCT00400153|Secondary|FVC AUC4-6 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29|Between 4 hours and 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
1264756|NCT00400153|Secondary|FVC AUC4-6 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1|Between 4 hours and 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
1264833|NCT00399542|Secondary|Month 3 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF|||SBMs/week||Standard Deviation|Mean
1264757|NCT00400153|Secondary|FVC AUC0-4 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85|Before drug administration to 4 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264758|NCT00400153|Secondary|FVC AUC0-4 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57|Before drug administration to 4 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264759|NCT00400153|Secondary|FVC AUC0-4 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29|Before drug administration to 4 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264760|NCT00400153|Secondary|FVC AUC0-4 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1|Before drug administration to 4 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264761|NCT00400153|Secondary|FVC AUC0-6 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85|Before drug administration to 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264762|NCT00400153|Secondary|FVC AUC0-6 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57|Before drug administration to 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264763|NCT00400153|Secondary|FVC AUC0-6 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29|Before drug administration to 6 hours after drug administration at Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264764|NCT00400153|Secondary|FVC AUC0-6 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1|Before drug administration to 6 hours after drug administration at Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264765|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 85|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85|Within the 6-hour post-treatment observation period at Day 85|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264766|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 57|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57|Within the 6-hour post-treatment observation period at Day 57|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264767|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 29|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29|Within the 6-hour post-treatment observation period at Day 29|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264768|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 1|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1|Within the 6-hour post-treatment observation period at Day 1|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264769|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 85|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85|During the 6-hour observation period after drug administration at Day 85|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264770|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 57|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57|During the 6-hour observation period after drug administration at Day 57|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264771|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 29|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29|During the 6-hour observation period after drug administration at Day 29|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264772|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 1|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1|During the 6-hour observation period after drug administration at Day 1|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264773|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 85|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264774|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 57|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264834|NCT00399542|Secondary|Month 2 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF|||SBMs/week||Standard Deviation|Mean
1264775|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 29|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264776|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 1|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
1264777|NCT00400153|Secondary|Peak FEV1 Response at Day 85|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264778|NCT00400153|Secondary|Peak FEV1 Response at Day 57|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264779|NCT00400153|Secondary|Peak FEV1 Response at Day 29|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264780|NCT00400153|Secondary|Peak FEV1 Response at Day 1|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264781|NCT00400153|Secondary|Peak FEV1 Response at Day 85|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264782|NCT00400153|Secondary|Peak FEV1 Response at Day 57|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264783|NCT00400153|Secondary|Peak FEV1 Response at Day 29|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264784|NCT00400153|Secondary|Peak FEV1 Response at Day 1|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264785|NCT00400153|Secondary|FEV1 AUC4-6 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57|Between 4 hours and 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
1264786|NCT00400153|Secondary|FEV1 AUC4-6 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29|Between 4 hours and 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
1264787|NCT00400153|Secondary|FEV1 AUC4-6 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1|Between 4 hours and 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
1264788|NCT00400153|Secondary|FEV1 AUC0-4 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57|Before drug administration to 4 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264789|NCT00400153|Secondary|FEV1 AUC0-4 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29|Before drug administration to 4 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264790|NCT00400153|Secondary|FEV1 AUC0-4 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1|Before drug administration to 4 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264791|NCT00400153|Secondary|FEV1 AUC0-6 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57|Before drug administration to 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264792|NCT00400153|Secondary|FEV1 AUC0-6 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29|Before drug administration to 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264793|NCT00400153|Secondary|FEV1 AUC0-6 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1|Before drug administration to 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264794|NCT00400153|Primary|FEV1 AUC4-6 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85|Between 4 hours and 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
1264795|NCT00400153|Primary|FEV1 AUC0-4 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85|Before drug administration to 4 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264796|NCT00400153|Primary|FEV1 AUC0-6 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85|Before drug administration to 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
1264797|NCT00399893|Primary|Number of Participants With Improved Peptide YY (PYY) Regulation From Baseline to 6 Months|Number of participants with improved Peptide YY (PYY) regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|Participant withdrew but data was used for analysis|||participants|||Number
1264798|NCT00399893|Primary|Number of Participants With Improved Leptin Regulation From Baseline to 6 Months|Number of participants with improved Leptin regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months||||participants|||Number
1264799|NCT00399893|Primary|Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months|Number of participants with improved Adiponectin regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|A participant withdrew but data was used for analysis|||participants|||Number
1264800|NCT00399893|Primary|Number of Participants With Improved Insulin Regulation From Baseline to 6 Months|Number of participants with improved Insulin regulation from baseline to 6 months of Octreotide or Placebo therapy. Insulin regulation was measured by immunochemiluminescent assay.|6 months|Participant withdrew but was used in the data analysis|||participants|||Number
1264801|NCT00399893|Secondary|Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA|Number of participants with decreased body-composition as Measured by Dual Energy X-ray Absorptiometry (DEXA) scan from baseline to 6 months of Octreotide or Placebo therapy|6 months|Data for this outcome was not analyzed|||participants|||Number
1264802|NCT00399893|Primary|Number of Participants With Decrease in Hunger and Food Intake|Measured by hunger and hyperphagia by questionnaires and parent-reported 72-hour food recall from baseline to 6 months. Multiple questionnaires consisting of a battery of free text answer questions and food diaries are combined in order to make a behavioral assessment of the participants food state of hunger and food intake. There is no defined scale for this assessment. Each participants responses and parent responses are combined.|6 months|For this outcome measure, data from questionnaires and forms was not completed. Data for all questionnaires is not available to report.||||||
1264803|NCT00399893|Primary|Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months|Number of participants with decreased skin-fold measurements from baseline to 6 months of Octreotide or Placebo therapy|6 months|The skin fold measurements were performed; however, the data was not completed in a manner that could be analyzed; therefore we could not analyze the data. Completed data is not available to complete this outcome.||||||
1264804|NCT00399893|Primary|Number of Participants With Decreased BMI Z-score From Baseline to 6 Months|Number of participants with decreased BMI z-score from baseline to 6 months of Octreotide or Placebo therapy|6 months|A participant withdrew but was included in analysis|||participants|||Number
1264805|NCT00399893|Primary|Number of Participants With Decrease in Weight From Baseline to 6 Months|Number of participants who had a decrease in weight from baseline to 6 months of Octreotide or placebo therapy|6 months||||participants|||Number
1264806|NCT00399893|Secondary|Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD®|Number of participants with decreased body-composition as Measured by BOD POD® body composition tracking system from baseline to 6 months of Octreotide or Placebo therapy|6 months|Participant withdrew but data was used for analysis|||participants|||Number
1264807|NCT00399893|Primary|Number of Participants With Decrease in Fasting Total Ghrelin|Number of participants showing a decrease in Fasting total ghrelin from baseline to 6 months of treatment with Octreotide or placebo|6 months|"Descriptive statistics or percent of change from the baseline for the 5 patients was used.~A patient withdrew but included in analysis."|||Participants|||Number
1264808|NCT00399880|Secondary|Self-Efficacy for Appropriate Medication Use Scale (SEAMS)|Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.|Approximately 2 weeks after hospital discharge|Participants who were able to be contacted and provided outcome data.|||units on a scale||Standard Deviation|Mean
1264809|NCT00399880|Primary|Adherence to Refills and Medications Scale (ARMS)|Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.|Approximately 2 weeks after hospital discharge|Participants who were able to be contacted and provided outcome data.|||units on a scale||Standard Deviation|Mean
1264810|NCT00399802|Secondary|Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4|u-DPD is a biochemical marker of bone resorption. Participants provided urine specimens on Day 1 (baseline) and Week 4 for measurement of u-DPD.|Baseline and Week 4|All randomized participants who took at least one dose of study drug and had available u-DPD data for Baseline and Week 4|||Percentage change||95% Confidence Interval|Mean
1264811|NCT00399802|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 4 weeks|All randomized participants who took at least one dose of study drug|||Participants|||Count of Participants
1264812|NCT00399802|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 6 weeks|All randomized participants who took at least one dose of study drug|||Participants|||Count of Participants
1264813|NCT00399802|Primary|Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4|u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.|Baseline and Week 4|All randomized participants who took at least one dose of study drug and had available u-NTx data for Baseline and Week 4|||Percentage change||95% Confidence Interval|Mean
1264814|NCT00399763|Secondary|Side Effect Form for Children and Adolescents (SEFCA)|The SEFCA is a clinician-administered instrument that systematically assesses 52 possible side effects and rates them on a scale of 0 (not present) to 3 (severe). The instrument relies on confidential, self-report of the adolescent.The number of serious adverse events was recorded by intervention assignment.|weekly from randomization to 12 weeks post-randomization||||Number of serious adverse events|||Number
1264815|NCT00399763|Secondary|Time Line Followback Interview (TLFB)|The TLFB assesses the number of days in which a substance was used in the past 28 days. The TLFB is administered by the clinician and uses a 28-day calendar with anchor points to record this information. This instrument relies on confidential self-report of the adolescent participant. The result is reported as mean change in the number of days used substances in the past 28 days from baseline to the end of treatment using linear mixed models in an intent-to-treat analysis.|12 weeks||||days||95% Confidence Interval|Mean
1264816|NCT00399763|Primary|Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist|All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis.|baseline and weekly through week 12 post randomization||||units on a scale||95% Confidence Interval|Mean
1264817|NCT00399568|Secondary|Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.|"Number of subjects who reported SAEs during the study.~A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:~Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event"|32 days following first dose of study medication.||||Subjects|||Number
1264818|NCT00399568|Primary|Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo|"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-4800 mm for 48 hours."|Baseline (just prior to the first dose) through 48 hours|All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication.|||units on a scale (in millimeters)||Standard Deviation|Mean
1264819|NCT00399568|Secondary|Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)|Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)|First dose through 7 day follow up|All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of study medication.|||Subjects|||Number
1264820|NCT00399568|Primary|Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.|"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-2400 mm for 24 hours."|Baseline (just prior to the first dose) through 24 hours|All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication.|||units on a scale (in millimeters)||Standard Deviation|Mean
1264821|NCT00399542|Secondary|Month 3 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF|||BMs/week||Standard Deviation|Mean
1264822|NCT00399542|Secondary|Month 2 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF|||BMs/week||Standard Deviation|Mean
1264823|NCT00399542|Secondary|Month 1 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF|||bowel movements (BMs)/week||Standard Deviation|Mean
1264824|NCT00399542|Secondary|Month 3 Quality of Life Change From Baseline|IBS-QOL questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase|12 weeks|ITT without LOCF|||units on a scale||Standard Deviation|Mean
1264825|NCT00399542|Secondary|Month 3 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264826|NCT00399542|Secondary|Month 2 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264827|NCT00399542|Secondary|Month 3 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264828|NCT00399542|Secondary|Month 2 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264829|NCT00399542|Secondary|Month 3 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264830|NCT00399542|Secondary|Month 2 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264831|NCT00399542|Secondary|Month 3 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264841|NCT00399542|Secondary|Month 3 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF|||percentage of participants|||Number
1264842|NCT00399542|Secondary|Month 2 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF|||percentage of participants|||Number
1264843|NCT00399542|Secondary|Month 1 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF|||percentage of participants|||Number
1264844|NCT00399542|Secondary|Month 1 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264845|NCT00399542|Secondary|Month 1 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264846|NCT00399542|Secondary|Month 1 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264847|NCT00399542|Secondary|Month 1 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
1264848|NCT00399542|Secondary|Month 1 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF|||spontaneous bowel movements (SBMs)/week||Standard Deviation|Mean
1264849|NCT00399542|Primary|Overall Responder Status|"Overall responder: monthly responder for at least 2 out of 3 months~Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|12 weeks|Intention to treat (ITT), without Last Observational Carried Forward (LOCF).|||percentage of participants|||Number
1264850|NCT00399516|Primary|Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)|"Pain severity as measured by NRS quantifies pain, where 0 is no pain and 10 is worst pain imaginable"|Within 6 months post-implantation||||Percent Change in Pain Rating||Standard Deviation|Mean
1264851|NCT00399360|Secondary|Intramyocellular Lipid|Intramyocellular lipid (IMCL) of the tibialis anterior was determined using 1H-magnetic resonance spectroscopy (Siemens, Munich, Germany). The change in the intramyocellular lipid measurement between baseline and 12 months is reported.|baseline and 12 months||||mmol/kg||Standard Error|Mean
1264852|NCT00399360|Secondary|Cardiorespiratory Fitness|A submaximal exercise stress test was conducted on a cycle ergometer to measure endurance. Subjects cycled between 50-60 revolutions per minute and the workload was progressively increased in increments of 50 watts in stages lasting 3 minutes. Once subjects became fatigued or reached their submaximal heart rate (220-age x 85), the test was stopped and separate readings of heart rate and blood pressure were measured at 1, 3, and 5 min of recovery. Weight-adjusted maximum oxygen consumption (VO2max; ml/kg per minute) was determined. The change in cardiorespiratory fitness between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||ml/kg/min||Standard Error|Mean
1264853|NCT00399360|Secondary|Abdominal Visceral Adiposity|Abdominal visceral adipose area was assess by magnetic resonance imaging at the lvel of the L4 pedicle. The change in abdominal visceral adiposity between baseline and 12 months is reported.|baseline and 12 months||||cm2||Standard Error|Mean
1264854|NCT00399360|Secondary|C-reactive Protein|High sensitivity C-reactive protein was determined by R&D Systems (Minneapolis, MN) kit. The change in C-reactive protein between baseline and 12 months is reported.|baseline and 12 months||||mg/l||Standard Error|Mean
1264855|NCT00399360|Primary|Coronary Artery Calcium Score|Computed tomography (CT) imaging was performed using a SOMATOM Sensation (Siemens Medical Solutions, Forcheim, Germany) 64-slice CT scanner. Agatston calcium score was calculated using CT images. The total Agatston score is calculated by summing up the scores of the individual calcifications in all slices of the CT scan. An absolute Agatston score of less than 10 indicates minimal overall atherosclerosis (plaques) in the coronary arteries. The change in the coronary artery calcium score between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||Agatston score||Standard Error|Mean
1264856|NCT00399360|Primary|Systolic Blood Pressure|Systolic blood pressure was measured after 5 minutes rest. The in systolic blood pressure between baseline and 12 months is reported.|baseline and 12 months||||mm Hg||Standard Error|Mean
1264857|NCT00399360|Primary|Glucose|Glucose level was determined after an overnight fast. The change in glucose between baseline and 12 months is reported.|baseline and 12 months||||mg/dL||Standard Error|Mean
1264858|NCT00399360|Primary|High Density Lipoprotein (HDL)|High density lipoprotein (HDL) was determined after an overnight fast. The change in HDL between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||mg/dL||Standard Error|Mean
1264966|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
1264859|NCT00399360|Primary|Waist Circumference|Iliac waist circumference measurements were obtained using an inelastic tape measure. All measurements were obtained in triplicate, with the patient undressed, and then averaged. The change of the waist circumference measurement between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||cm||Standard Error|Mean
1264860|NCT00399360|Primary|Carotid Intima Media Thickness|Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||mm||Standard Error|Mean
1264861|NCT00399308|Secondary|Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).|The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.|24 weeks|Intent-to-Treat population|||participants|||Number
1264862|NCT00399308|Secondary|Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.|The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.|Variable - minimum of 12 weeks of follow-up.|Intent-to-treat population achieving primary outcome|||participants|||Number
1264863|NCT00399308|Secondary|Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.|Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.|12 Weeks|Intent-to-Treat population|||participants|||Number
1264864|NCT00399308|Primary|Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator’s Direct Observation.|The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)|12 weeks|Intent-to-Treat population (i.e. all subjects randomized to treatment)|||participants|||Number
1264865|NCT00399035|Secondary|Time to Wound Healing Complications|Number of days from post-randomisation surgery until wound healing complications|Post-randomisation until end of study|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Days||Full Range|Median
1264866|NCT00399035|Secondary|Rate of Resection of Liver Metastases|Number of patients undergoing liver resection, based on patients with liver disease at baseline|Post-randomisation until end of study|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Participants|||Number
1264867|NCT00399035|Secondary|Duration of Response|Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.|Treatment period from initial response up until data cut-off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
1264868|NCT00399035|Secondary|Best Percentage Change in Tumour Size|Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Percentage [change in tumour size (mm) ]||Standard Deviation|Mean
1264869|NCT00399035|Secondary|Overall Response Rate|Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Participants|||Number
1264870|NCT00399035|Primary|Overall Survival|Number of months from randomisation to the date of death from any cause|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
1295930|NCT00075478|Secondary|Incidence of Relapse/Progression|Percentage of relapse estimated by cumulative incidence methods|3 years after transplant||||percentage of participants|||Number
1264871|NCT00399035|Primary|Progression-free Survival|RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.|RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation.The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
1264872|NCT00398983|Primary|Number of Participants With Relapse-Free Response at 1 Year|Relapse free response defined an absence of relapse at one year of follow up.|Baseline to 1 year||||participants|||Number
1264873|NCT00398918|Secondary|Score Digit Symbol Modalities Test|Difference score between zonisamide and placebo treatment conditions for the Digit Symbol Modalities Test scores obtained 40 minutes after ingestion of a priming dose of ethanol.This test involves transcribing from a key in which numbers appear below a series of symbols to boxes below symbols matched to those in the key. This task must be completed in 90 nseconds. This test measures visuomotor speed and aspects of attention. Scoring is the total number of correctly transcribed numbers. The maximum score on this test 110 points.|40 minutes post alcohol ingestion|ITT|||Numeric Score||Standard Error|Mean
1264874|NCT00398918|Primary|Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions|Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions|1 day|This was a laboratory based study. An ITT analysis was used.|||Grams||Standard Error|Mean
1264875|NCT00398866|Secondary|Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire|Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire measures degree of disability on a scale of 0 to 100, with a higher score indicating greater disability.|Baseline, 26 Weeks|Patients who completed follow-up through 26 weeks|||units on a scale||Standard Deviation|Mean
1264876|NCT00398866|Primary|Pain Visual Analogue Scale (VAS)|Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.|Baseline, 26 Weeks|Patients who completed follow-up through 26 weeks|||Units on a scale||Standard Deviation|Mean
1264877|NCT00398632|Secondary|Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology–Clinician Rated (IDS-C) at End of Study|The IDS-C is a 30-item inventory designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes. Scores less than or equal to 6 indicated remission in this study.|Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)|All participants; the last observed non-missing value was used (LOCF)|||Participants|||Count of Participants
1264878|NCT00398632|Primary|Global Clinical Impressions Improvement Score re Sexual Functioning|The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction.|baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)|Four subjects completed the study; two withdrew at end of week six. CGI-I ratings for two subjects were done at end of week 6 and this last observation was carried forward in the analysis. CGI-I ratings for the 4 completing subjects were done at end of week 12.|||participants|||Number
1264879|NCT00398567|Secondary|Terminal-phase Elimination Half-life of Neratinib in Combination With Trastuzumab.|Terminal-phase elimination half-life of Neratinib at day 22 following Administration of Neratinib 240 mg in combination with Trastuzumab 2 mg/kg to Subjects with Cancer.|Prior to the first dose, on days 22 through 23 of month 1, and on day 1 in months 2 through 6|Subjects for whom complete blood samples at day 22 were available.|||hr||Standard Deviation|Mean
1264880|NCT00398567|Secondary|Area Under the Curve of Neratinib Concentration|Area Under the Curve of Neratinib concentration at day 22 following Administration of Neratinib 240 mg in combination with Trastuzumab 2 mg/kg in Subjects with Cancer.|Prior to the first dose, and at hours 1, 2, 4, 6, 8 and 24 on days 22.|Subjects for whom complete blood samples at day 22 were available.|||ng*hr/mL||Standard Deviation|Mean
1264881|NCT00398567|Secondary|Clinical Benefit Rate (CBR)|The percentage of participants with a best overall response of a complete response (CR) or partial response (PR) or stable disease (SD) >=24 weeks.|From first dose date to progression or last tumor assessment, assessed up to five and half years.|The evaluable population was defined as the subjects who met the eligibility criteria for study enrollment, received at least 1 week of neratinib and at least 2 doses of trastuzumab, and had a baseline tumor assessment and at least 1 follow-up tumor assessment approximately 8 weeks after starting test article administration.|||percentage of participants||95% Confidence Interval|Number
1264882|NCT00398567|Secondary|Progression Free Survival (PFS)|Progression Free Survival was measured from the date of the first dose of test article until the first date on which recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment.|From first dose date to progression or death, assessed up to five and half years.|The evaluable population was defined as the subjects who met the eligibility criteria for study enrollment, received at least 1 week of neratinib and at least 2 doses of trastuzumab, and had a baseline tumor assessment and at least 1 follow-up tumor assessment approximately 8 weeks after starting test article administration.|||weeks||95% Confidence Interval|Median
1264883|NCT00398567|Secondary|Duration of Response (DOR)|Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date on which recurrence or PD was objectively documented, taking as the reference for PD the smallest measurements recorded since the test article administration started.|From start date of response to first PD, assessed up to five and half years after the first subject was randomized|The subjects who had a complete response or partial response.|||weeks||95% Confidence Interval|Median
1264884|NCT00398567|Secondary|Objective Response Rate (ORR)|Percentage of participants with partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to five and a half years.|The evaluable population was defined as the subjects who met the eligibility criteria for study enrollment, received at least 1 week of neratinib and at least 2 doses of trastuzumab, and had a baseline tumor assessment and at least 1 follow-up tumor assessment approximately 8 weeks after starting test article administration.|||percentage of participants||95% Confidence Interval|Number
1264885|NCT00398567|Primary|16-week Progression-free Survival (PFS) Rate|16-week progression-free survival (PFS) rate for subjects with advanced breast cancer who receive neratinib at the maximum tolerated dose (MTD) in combination with trastuzumab, evaluable population.|From first dose date to progression status (PD or death) at 16-week|The evaluable population was defined as the subjects who met the eligibility criteria for study enrollment, received at least 1 week of neratinib and at least 2 doses of trastuzumab, and had a baseline tumor assessment and at least 1 follow-up tumor assessment approximately 8 weeks after starting test article administration.|||percentage of population||95% Confidence Interval|Number
1264886|NCT00398476|Secondary|Number of Participants Comply With Product if Prescribed in DAQ|Number of participants responding to product attributes using delayed attributes questionnaire, Question: How likely to comply if prescribed?. Participants specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264887|NCT00398476|Secondary|Number of Participants Reported Nasal Irritation Bothersome in DAQ|Participant response regarding bothersome of nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How bothersome was nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264888|NCT00398476|Secondary|Number of Participants Reported Nasal Irritation in DAQ|Participant response regarding nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product cause nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slight; 2: slight; 3: neither slight nor moderate; 4: moderate; 5; marked; 6: very marked.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264889|NCT00398476|Secondary|Number of Participants Satisfied With Product in DAQ|Number of participants responding to product satisfaction with delayed attributes questionnaire, Question: How satisfied with product?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264890|NCT00398476|Secondary|Number of Participants Reported Product Make Want to Sneeze in IAQ|Participant response regarding sneezing effect at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product make want to sneeze?. Participants specified their responses on a 6-point scale: 0: No urgency; 1: Very slight urgency; 2: slight urgency; 3: Neither slight nor moderate urgency; 4: Moderate urgency; 5; Marked urgency; 6: Very marked urgency.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264891|NCT00398476|Secondary|Number of Participants Reported Product Feel Soothing in IAQ and DAQ|Participant response for soothing feel at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product feel soothing?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.|Day 1|Per Protocol population comprised of all participants who complete both treatment periods. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1264892|NCT00398476|Secondary|Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ|Participant response regarding did the medicine run out of nose at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run out of nose? Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264893|NCT00398476|Secondary|Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ|Participant response regarding did the medicine run down throat at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run down throat? Participants specified their responses on a 6-point scale: 0: None; 1: Very slightly; 2: Slightly; 3: Neither slightly nor moderately; 4: Moderately; 5: Markedly; 6: Very markedly.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1264906|NCT00398411|Secondary|Reason for Discontinuation of Treatment|Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason|end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)|||participants|||Number
1264894|NCT00398476|Secondary|Number of Participants Satisfied With an After Taste in DAQ|Participant response for satisfaction with an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How satisfied with aftertaste? Participants specified their responses on a 6-point scale: 0: Very satisfied; 1: Moderately satisfied; 2: Somewhat satisfied; 3: Neither satisfied nor dissatisfied; 4: Somewhat dissatisfied; 5: Moderately dissatisfied; 6: Very dissatisfied.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264895|NCT00398476|Secondary|Number of Participants Reported Product Have an After Taste in DAQ|Participant response for an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product have an aftertaste?. Participants specified their responses on a 6-point scale: 0: No aftertaste; 1: Very mild; 2: Mild; 3: Neither mild nor strong; 4: Slightly strong; 5: Moderately strong; 6: Very strong.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264896|NCT00398476|Secondary|Number of Participants Satisfied With an Immediate Taste in IAQ|Participant preference for satisfaction with an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with immediate taste?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264897|NCT00398476|Secondary|Number of Participants Reported Product Have an Immediate Taste in IAQ|Participant preference for an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product have an immediate taste?. Participants specified their responses on a on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264898|NCT00398476|Secondary|Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ|Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1264899|NCT00398476|Secondary|Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ|Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1264900|NCT00398476|Secondary|Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ|Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1264901|NCT00398476|Secondary|Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ|Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1264902|NCT00398476|Secondary|Number of Participants With Preference for Scent/Odor in IAQ and DAQ|Participant preference for scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product have a scent/odor?. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Higher score indicated strong odor.|Day 1|Per Protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1264903|NCT00398476|Primary|Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing|An overall preference questionnaire (OPQ) was used to evaluate participant’s preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.|Day 1|Per Protocol population comprised of all participants who completed both treatment periods. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1264904|NCT00398411|Secondary|Overall Survival||follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)|intention to treat (ITT)|||participants|||Number
1264905|NCT00398411|Secondary|Type of Infection||follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)|intention to treat (ITT)|||participants|||Number
1264907|NCT00398411|Secondary|Time to Occurrence of Fever >= 38°C||end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)|||days||Standard Deviation|Mean
1264909|NCT00398411|Primary|Incidence of Clinically Significant Bacteremia|"Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary.~With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant."|end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)|||participants|||Number
1264910|NCT00398398|Secondary|Toxicity Profile|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of XELOX plus Cetuximab|1 years||||participants|||Number
1264911|NCT00398398|Secondary|Overall Survival||1 year||||months||95% Confidence Interval|Median
1264912|NCT00398398|Secondary|Progression-free Survival||1 year||||months||95% Confidence Interval|Median
1264913|NCT00398398|Primary|Overall Response Rate|Tumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders.|6 months||||participants|||Number
1264914|NCT00398320|Secondary|Biochemical Markers||Assessed every 3 weeks while on treatment|18 of 40 patients had elevated baseline hormone markers, including Chromogranin A, Gastrin, Glucagon, Pancreatic Polypeptide, vasoactive intestinal peptide (VIP), Urine 5HIAA|||participants|||Number
1264915|NCT00398320|Secondary|Overall Survival (OS)|OS is defined as time from enrollment until death from any cause.|Continuous||||months||Full Range|Median
1264916|NCT00398320|Secondary|Response Rates|Response rate is defined as percent of patients with complete response (CR) and partial response (PR) as their best response as defined by RECIST criteria (version 1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as ≥ 30 decrease in the sum of longest diameters of target lesions (SLD). Overall response (OR) = CR + PR.|Response rates by RECIST criteria assessed every 3 months while on treatment||||percentage of participants|||Number
1264917|NCT00398320|Primary|Number of Patients Who Experienced Treatment-related Grade 3 or Higher Adverse Events by CTCAE Version 3.0|Participants were monitored every 3 weeks while on study. Toxicity and attributions were as per CTCAE version 3.0 guidelines. Analysis population below is patient who experienced related Grade 3 or higher AE; denominator is 40 total patients enrolled.|30 days after last treatment||||participants|||Number
1264918|NCT00398320|Primary|12-month Progression Free Survival (PFS)|Percentage of participants with 12-month progression-free survival (PFS) was assessed. PFS is defined as the time from enrollment until documented disease progression or death (whichever occurred first). RECIST criteria (version 1). Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR) defined as ≥ 30% decrease of SLD. Progressive disease (PD) defined as ≥ 20% increase in Sum Longest Diameters (SLD). Stable Disease (SD) defined as being between 20% increase and < 30% decrease in SLD.|PFS assessed every 3 months through 12 months||||percentage of participants w/ 12 mo PFS|||Number
1264919|NCT00398216|Secondary|Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events|adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose|10 days after first dose|safety analysis dataset|||percentage of subjects with bleed events||95% Confidence Interval|Number
1264920|NCT00398216|Secondary|Change in Activated Partial Thromboplastin Time (aPTT) From Baseline|change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery|end of treatment|perp protocol analysis set|||seconds||Standard Deviation|Mean
1264921|NCT00398216|Secondary|Change in Prothrombin Time (PT) From Baseline|change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery|end of treatment|perp protocol analysis set|||seconds||Standard Deviation|Mean
1264922|NCT00398216|Primary|Adjudicated Incidence of VTE|"Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery.~A subject was judged to have a VTE if one or more of the following criteria were met:~Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit~Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit~Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery."|end of treatment|per protocol analysis set|||percentage of participants with VTE||95% Confidence Interval|Number
1264923|NCT00398138|Primary|Immune Response|Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well.|2 years||||participants|||Number
1264924|NCT00398138|Primary|Safety|Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).|2 years||||participants|||Number
1264925|NCT00398112|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR or PR) until the date of progression or last follow-up in the subset of patients who responded. The median duration of response with 95%CI was estimated using the Kaplan Meier method|Duration on study (up 2 years)|No participants had a confirmed response, there for this analysis cannot be completed.||||||
1264926|NCT00398112|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from registration to progression or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)||||months||95% Confidence Interval|Median
1264927|NCT00398112|Secondary|Survival Time|Survival time was defined as the time from registration to death due to any cause. The distribution of survival time was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)||||Months||95% Confidence Interval|Median
1264928|NCT00398112|Secondary|Complete Response Rate in Patients With B-cell Chronic Lymphocytic Leukemia|Complete response is described in the primary outcome|Duration of Treatment (up to 12 cycles)|No participants had a confirmed response, there for this analysis cannot be completed.||||||
1264929|NCT00398112|Primary|Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart|"National Cancer Institute working group criteria (NCIWG) was used to assess response. >~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy >~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|Duration of Treatment (up to 12 cycles)||||participants|||Number
1264930|NCT00398086|Secondary|Maximal Degree of Anemia|The maximal degree of anemia (and myelosuppression) was assessed by the overall (any time after first dose of study drug) nadir of hemoglobin levels based on clinical laboratory measurements.|During the treatment phase, up to a maximum of 24 months.|Treated patients with available data|||g/L||Standard Deviation|Mean
1264931|NCT00398086|Secondary|Maximal Degree of Myelosuppression|The maximal degree of myelosuppression was assessed by the overall nadir of absolute neutrophil count (ANC), white blood cell count and platelet count based on clinical laboratory measurements.|During the treatment phase, up to a maximum of 24 months.|Treated patients with available data|||x10^9/L||Standard Deviation|Mean
1264932|NCT00398086|Secondary|Overall Survival|Overall survival was defined as the time from the date of first dose of study drug to the date of patient death from all causes. Participants who did not die were censored at the last known time the patient was alive. Patient survival was summarized using Kaplan-Meier methods.|Up to approximately 4 years|Treated patients|||months||95% Confidence Interval|Median
1264933|NCT00398086|Secondary|Duration of Response|Duration of response was assessed by progression-free survival for participants who achieved a confirmed Complete Response or Partial Response, assessed by an Independent Radiological Reviewer.|Up to approximately 4 years|Treated patients with an overall confirmed Complete Response or Partial Response.|||months||95% Confidence Interval|Median
1264934|NCT00398086|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first, assessed by an Independent Radiological Reviewer. Participants who do not have disease progression or have not died were censored at the last known time that the participant was progression free. Progression-free survival was summarized using Kaplan-Meier methods.~Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to approximately 4 years|Treated patients|||months||95% Confidence Interval|Median
1264935|NCT00398086|Secondary|Percentage of Participants With Disease Control|"Disease control is defined as participants with Stable Disease for at least 16 weeks, or confirmed complete or partial overall response, based on RECIST guidelines and assessed by an Independent Radiological Reviewer.~Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease, and no new non-target lesions or unequivocal progression of existing non-target lesions. Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to approximately 4 years|Treated patients|||percentage of participants||95% Confidence Interval|Number
1264936|NCT00398086|Secondary|Percentage of Participants Who Achieved an Objective Confirmed Overall Response|"Overall Response is defined as the percent of participants who achieve an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, assessed by an Independent Radiological Reviewer.~CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers.~PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing."|Up to approximately 4 years|Treated patients|||percentage of participants||95% Confidence Interval|Number
1264937|NCT00398086|Secondary|Number of Participants With Adverse Events (AE)|"An AE was any untoward medical occurrence, not necessarily having a causal relationship with the patient’s treatment, that began or worsened in grade after the start of study drug through 30 days after the last dose.~A serious AE (SAE) is any untoward medical occurrence that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~Treatment-related AEs (TRAEs) include those assessed by the Investigator as possibly, probably, or definitely related to study treatment.~Severity was graded according to the NCI CTCAE based on the following: Grade 1- Mild; Grade 2 -Moderate; Grade 3 - Severe; Grade 4 - Life-threatening or disabling; Grade 5 - Death related to AE."|Up to 25 months|Treated patients: all enrolled patients who received at least one dose of study drug.|||participants|||Number
1264938|NCT00398086|Primary|Number of Participants With Dose-limiting Toxicities|"A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3:~Grade 4 neutropenia lasting >3 days in the absence of growth factor support;~Grade 4 neutropenia associated with fever >38.5°C;~Any other Grade 4 hematological toxicity;~Grade 3 thrombocytopenia with hemorrhage;~Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen;~Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue."|Cycle 1 (Days 1-28)|Phase 1 treated population|||participants|||Number
1264967|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
1264939|NCT00398073|Secondary|Number of Participants With Response|In patients with measurable disease, the RECIST criteria for anti-tumor effect will be used. Lesions will be defined as measurable if they can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm by spiral CT scan.Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|2 years||||participants|||Number
1264940|NCT00398073|Primary|Number of Participants With a T-cell Response|T-cell response: Peripheral blood lymphocytes will be tested for reactivity against gp100 using an IFN-y ELISPOT, intracellular cytokine staining or MHC tetramer assay. If T-cell reactivity is induced, additional samples may be drawn to determine the duration of this reactivity. Follow-up blood samples require only 20-30 ml. MHC tetramer assays and intracellular flow cytometry studies may also be performed.|2 years||||participants|||Number
1264941|NCT00398073|Primary|Number of Patients Evulated for Toxicity and Safety|All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.|2 years||||participants|||Number
1264942|NCT00398047|Secondary|Expression of p53 and p21||Approximately 12 months|Because no patients completed therapy, no analysis was possible||||||
1264943|NCT00398047|Secondary|Change in Bone Marrow Apoptosis||Baseline and approximately 12 months|Because no patients completed therapy, no analysis was done||||||
1264944|NCT00398047|Secondary|Overall Survival||Approximately 12 months|Because no patients completed therapy, and the protocol was closed early, analysis was not performed||||||
1264945|NCT00398047|Secondary|Time to Progression to Acute Myeloid Leukemia (Blast ≥ 20%) or Death|Death during treatment or disease progression characterized by worsening of cytopenias, increase in the percentage of the blasts, reduction of hemoglobin concentration by at least 2 g/dl or transfusion dependence in the absence of another explanation, such as acute infection, gastrointestinal bleeding, hemolysis.|Approximately 12 months|Because no patients completed therapy, no analysis was possible||||||
1264946|NCT00398047|Secondary|Minor Hematological Improvements|For patients with pretreatment platelet count less than 100,000/mm3, a 50% or more increase in platelet count with a net increase greater than 10,000/mm3 but less than 30,000/mm3|Approximately 112 days|Because no patients completed therapy, no analysis was possible||||||
1264947|NCT00398047|Primary|Rate of Major Hematological Improvement|For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for red cell transfusion-dependent patients, transfusion independence.|Approximately 112 days|Because no patients completed therapy, no analysis was possible||||||
1264948|NCT00398047|Primary|Number of Participants With Complete Response|Complete response is normalization of abnormal blood counts, and disappearance of signs of morphological changes in the bone marrow. If the previously present cytogenetic abnormalities are absent then it is referred also as a cytogenetic complete remission.|Approximately 112 days|There were a total of 3 patients accrued on this trial. All were eligible and evaluable for response and evaluable for toxicity, as per protocol.|||Participants|||Number
1264949|NCT00397982|Secondary|Progression-free Survival|Defined as the duration of time from start of treatment to time of progression, death or date of last follow-up.|Day 11 of courses 4, 8, 12, 16, 20, and 24, and then annually for up to 5 years|Entire study|||months||Full Range|Median
1264950|NCT00397982|Secondary|Comparison of Pre- vs Post-treatment Measurements of Biomarkers and Vascular System/Immune System Parameters|Biomarker expression in tumor and normal skin will be assessed by immunohistochemistry (IHC) or Western blotting, using marker-specific antibodies.|Day 1 of course 1 and day 8 of course 2|Detailed vascular changes were not assessed.||||||
1264951|NCT00397982|Secondary|Comparison of Biomarkers to Antitumor Activity/Patient Outcomes|Assessed in both tumor tissue pretreatment. Mutations in BRAF were assessed in all 16 of the patients and were assessed for any association with clinical response|Day 1 of course 1 and day 8 of course 2|Patients evaluable for clinical outcome with BRAF mutation status.|||Participants|||Count of Participants
1264952|NCT00397982|Secondary|Association Between Expression or Activation of One Biomarker With Another, With Biochemical and Clinical Responses, With Alterations in Cell Proliferation and Apoptotic Markers, and With Time to Progression|Changes in the ratio of phospho-S6Kinase (pS6K) S240/244 to total S6, in the tumor, from day 1 to day 23. These were assessed by reverse-phase protein array. A linear model was fit with PROC MIXED in SAS 9.3 using the log base 10 of expression as the outcome measure. This measure type is not listed in the data table form; so the number of patients who had decreases in that ratio is listed.|Day 1 of course 1 and day 8 of course 2|This analysis was performed for those participants with sufficient tumor available for analysis.|||participants who had decreases in ratio|||Number
1264953|NCT00397982|Secondary|Adverse Events in Participants With Stage III or IV Melanoma Treated With Temsirolimus and Bevacizumab|Defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during the study (having been absent at baseline) or if present at baseline, appears to worsen. Graded using scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Tabulated by type and severity: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|On days 1 and 8 of each cycle, and up to 2 years after registration.|Treatment related adverse events.|||participants|||Number
1264963|NCT00397943|Secondary|Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The reference seropositivity cut-off values for anti-M72 and anti-Mtb72F antibodies were ≥ 2.8 EU/mL and ≥ 1.0 EU/mL, respectively.|At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)|The analysis was performed on the According to protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
1264954|NCT00397982|Primary|Objective Tumor Response (Complete Response and Partial Response) and Progression in Participants With Stage III or IV Melanoma Following Treatment With Temsirolimus and Bevacizumab|Evaluated using Response Evaluation Criteria In Solid Tumor (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 18 weeks after registration.||||participants|||Number
1264955|NCT00397943|Secondary|Concentrations of IFN-γ Produced in Serum Samples|Concentrations are presented as geometric mean concentrations (GMCs), expressed in picogram per milliliter (pg/mL). The reference seropositivity cut-off value was equal to or above (≥) 1 pg/mL.|Prior to (Day 0 and Day 30) and one day (Day 1 and Day 31) after each vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||pg/mL||95% Confidence Interval|Geometric Mean
1264956|NCT00397943|Secondary|Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers|The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers.|At Year 2 (Month 24) and Year 3 (Month 36)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).|||Participants|||Count of Participants
1264957|NCT00397943|Secondary|Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers|The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers.|At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1264958|NCT00397943|Secondary|Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule|Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.|At Year 2 (Month 24) and Year 3 (Month 36)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1264959|NCT00397943|Secondary|Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule|Expressed cytokine combinations for CD4+ T-cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.|At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1264960|NCT00397943|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).|At Year 2 (Month 24) and Year 3 (Month 36)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1264961|NCT00397943|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs). Note: No vaccine induced responses were observed for CD8+ T-cells, so no results are presented throughout the record.|At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1264962|NCT00397943|Secondary|Antibody Concentrations Against M. Tuberculosis Fusion Protein M72|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EU/mL). The reference seropositivity cut-off value for anti-M72 antibodies was ≥ 2.8 EU/mL.|At Year 2 (Month 24) and Year 3 (Month 36)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).|||EU/mL||95% Confidence Interval|Geometric Mean
1264964|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
1264965|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 31|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
1264968|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
1264969|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
1264970|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
1264971|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 31|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
1264972|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
1264973|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
1264974|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
1264975|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
1264976|NCT00397943|Primary|Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264977|NCT00397943|Primary|Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264978|NCT00397943|Primary|Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264979|NCT00397943|Primary|Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264980|NCT00397943|Primary|Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264981|NCT00397943|Primary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 3 continued only for the M72/AS01B Group and M72/AS02A Group.|From Month 24 up to Month 36|The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 3 Safety Follow-Up (M72/AS01B and M72/AS02A groups).|||Participants|||Count of Participants
1264982|NCT00397943|Primary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 2 continued only for the M72/AS01B Group and M72/AS02A Group.|From Month 12 up to Month 24|The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 2 Safety Follow-Up (M72/AS01B and M72/AS02A groups).|||Participants|||Count of Participants
1264983|NCT00397943|Primary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 2 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264984|NCT00397943|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the Active Vaccination Phase (from Day 0 up to Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264985|NCT00397943|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264986|NCT00397943|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264987|NCT00397943|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1264988|NCT00397930|Primary|Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)|"Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.~PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms."|2-24 months after surgery, chemotherapy, and/or radiation therapy||||units on a scale||Standard Error|Mean
1264989|NCT00397904|Primary|Complete and Partial Response Rate||2 years||||participants|||Number
1264990|NCT00397891|Secondary|Plasma Amyloid-beta (x-40) Concentrations|Amyloid-beta (A-beta) is a peptide fragment of the amyloid precursor protein which is one of the characteristic hallmarks of Alzheimer's disease (AD). Total plasma amyloid-beta (x-40) was determined using a validated ELISA method.|0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
1264991|NCT00397891|Secondary|Number of Participants With Positive Serum Anti-Bapineuzumab Antibody|Serum anti-bapineuzumab antibody concentration was determined by using a validated ELISA method.|Baseline (Day 1) up to Week 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||participants|||Number
1264992|NCT00397891|Secondary|Serum Bapineuzumab Concentrations|Serum bapineuzumab concentration was determined by using a validated enzyme-linked immunosorbent assay (ELISA) method. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6, 24, 48, 168, 336, 672, 1008, 1344, 1848, 2184, 2688, 4368, 8736 hours post start of infusion|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1264993|NCT00397891|Secondary|Serum Decay Half-Life (t1/2) of Bapineuzumab|Serum decay half-life is the time measured for the serum concentration to decrease by one half. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||days||Standard Deviation|Mean
1265004|NCT00397891|Primary|Number of Participants With Clinically Significant Changes in Neurological Examinations|Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes.|Screening up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1264994|NCT00397891|Secondary|Mean Residence Time of Bapineuzumab|MRT is average time for which the drug molecules resides in the body, after administration. It is calculated as area under the serum concentration versus time first moment curve from time zero (pre-dose) to extrapolated infinite time (AUMC [0 - ∞]) divided by area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (AUC[0 - ∞]). AUMC (0-∞) is calculated as AUMC(0-inf)= AUMCt + [(t x Ct) / kel] + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method, Ct is the concentration at time t and kel is the terminal phase rate constant. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||days||Standard Deviation|Mean
1264995|NCT00397891|Secondary|Volume of Distribution at Steady State (Vss) of Bapineuzumab|Volume of distribution is defined as the theoretical blood volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||mL||Standard Deviation|Mean
1264996|NCT00397891|Secondary|Systemic Clearance (CL) of Bapineuzumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||mL/hour||Standard Deviation|Mean
1264997|NCT00397891|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab|AUC is a measure of the serum concentration of the drug over time. AUC (0 - ∞) is area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||mcg*hour/mL||Standard Deviation|Mean
1264998|NCT00397891|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab|AUC is a measure of the serum concentration of the drug over time. AUC (0-t) is area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||mcg*hour/mL||Standard Deviation|Mean
1264999|NCT00397891|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab|Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||hours||Full Range|Median
1265000|NCT00397891|Secondary|Maximum Observed Serum Concentration (Cmax) of Bapineuzumab|Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|Pharmacokinetic (PK) data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1265001|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1265002|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 16|Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1265003|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 6|Safety data set included all randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1265005|NCT00397891|Primary|Number of Participants With Laboratory Test Results of Potential Clinical Importance|Criteria for PCI laboratory results: hematology (hematocrit [decrease >=5%], hemoglobin [decrease >=20gram/liter {g/L}] from baseline, white blood cells [<3], neutrophils [<1.5], platelet [<100], eosinophils [>0.5] *10^9/L); blood chemistry (sodium [>5], potassium [>0.5], fasting glucose [>0.83], phosphorous [>0.162] millimole/L [mmol/L] above upper limit of normal [ULN] and below lower limit of normal [LLN], non-fasting glucose >5 mmol/L above ULN, >0.56 mmol/L below LLN, creatinine >1.36*ULN, blood urea nitrogen >1.5*ULN, calcium [change of >=0.25 mmol/L], total protein [change of >=20g/L], albumin [change of >=10g/L], uric acid [change of >0.119mmol/L] from baseline and outside normal limits); Liver function tests (alanine aminotransferase/serum glutamic pyruvic transaminase [ALT/SGPT] and aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] >2*ULN, total bilirubin >2*ULN, alkaline phosphatase >1.5*ULN, gamma-glutamyl-transpeptidase [GGT] >3*ULN).|Week 1 up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1265006|NCT00397891|Primary|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance|Criteria for determining PCI ECG result was described as: heart rate (>=120 bpm or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), PR interval (>=220 millisecond (msec) and change of >=20 msec compared to baseline value), QRS interval (>=120 msec), corrected QT (QTc) interval for men (>450 msec), QTc interval for women (>470 msec).|Screening up to Week 16|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1265007|NCT00397891|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Criteria for determining potentially clinically important (PCI) vital signs was described as: supine blood pressure (BP)- systolic (greater than or equal to [>=]160 millimeter mercury [mm Hg] or less than or equal to [<=]90 mm Hg and increase or decrease of >=20 mm Hg compared to baseline value), supine diastolic BP (>=100 mm Hg or <= 50 mm Hg and increase or decrease of >=15 mm Hg compared to baseline value), supine pulse rate (>=120 beats per minute (bpm) or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), body temperature (>38.3 degree Celsius and <35 degree Celsius).|Baseline up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1265008|NCT00397891|Primary|Number of Participants With Clinically Significant Changes in Physical Examinations|Physical examination included the assessment of abdomen, back/spinal, breasts, external genitalia, extremities, general appearance, head, eyes, ears, nose, throat (HEENT), heart, lungs, lymph nodes and skin.|Screening up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1265009|NCT00397891|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between dose of study medication and up to 52 weeks after the dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1265010|NCT00397878|Secondary|Pre- and Post-treatment Expression Values for Each Biological Correlate|Statistical significance of the associations assessed using a nonparametric Sign Test performed on the difference of the post-treatment and pre-treatment values. A two-sided .05 significance level to be used.|Up to 2 weeks|||||||
1265011|NCT00397878|Secondary|Time to Progression|Length of time from the start of treatment until disease progression using Kaplan-Meier estimates.|Up to 5 years|||||||
1265012|NCT00397878|Secondary|Overall Survival|Length of time from start of treatment that participants are still alive using Kaplan-Meier estimates.|Up to 5 years|||||||
1265013|NCT00397878|Primary|Median Progression Free Survival (PFS)|Proportion of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.|Time from start of treatment to time of progression, up to 4 months||||weeks||Full Range|Median
1265014|NCT00397839|Secondary|Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months|Responders are defined as participants who have BMD values >= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance.|12 months|Intent-to-treat population|||participants|||Number
1265015|NCT00397839|Secondary|Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|6 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.|||percent||Standard Error|Least Squares Mean
1265016|NCT00397839|Secondary|Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|12 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 12.|||percent||Standard Error|Least Squares Mean
1265017|NCT00397839|Secondary|Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|6 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.|||percent||Standard Error|Least Squares Mean
1265018|NCT00397839|Primary|Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|12 months|Intent-to-treat population. Includes participants with measurements at Baseline and Month 12.|||percent||Standard Error|Least Squares Mean
1265204|NCT00396279|Secondary|Number of Participants With Anti-Denosumab Antibodies|Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.|From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.|Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample.|||participants|||Number
1265019|NCT00397813|Secondary|Number of Patients With Relapse/Progression|Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.|1 year|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
1265020|NCT00397813|Secondary|Number of Patients With Progression-free Survival|Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.|1 year|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
1265021|NCT00397813|Secondary|Number of Patients Who Engrafted|Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%.|1 year|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
1265022|NCT00397813|Secondary|Number of Patients Who Had Infections|Number of patients who experienced bacterial, fungal, or viral infections.|1 year|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
1265023|NCT00397813|Primary|Number of Patients With HCT Failure.|HCT failure will be defined as graft rejection (defined as < 5% donor T-cell chimerism) or disease progression within 200 days of transplant.|200 days|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
1265024|NCT00397631|Secondary|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1265025|NCT00397631|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1265026|NCT00397631|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 24 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
1265027|NCT00397540|Secondary|Overall Survival|Assessment of overall survival rates was not carried out due to the relative, short-term median follow-up duration (28.9 months).|1,3,5-year Overall Survival|||||||
1265028|NCT00397540|Primary|1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)|The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.|1,3,5 year|ITT analysis|||participants|||Number
1265029|NCT00397514|Secondary|Cardio-pulmonary Bypass Time||Baseline and after 20 minutes||||min.||Full Range|Median
1265030|NCT00397514|Secondary|QRS Duration||Baseline and after 20 minutes of pacing||||ms||Full Range|Median
1265031|NCT00397514|Secondary|Ventilatory Support|||||||||
1265032|NCT00397514|Secondary|Inotropic Support|||||||||
1265033|NCT00397514|Secondary|TDI Indices (Tissue Velocities, Tissue Tracking, Regional Strain, and Regional Strain Rates)|||||||||
1265034|NCT00397514|Secondary|Incidence of Low Output Syndrome|||||||||
1265035|NCT00397514|Secondary|Systolic Blood Pressure|||||||||
1265036|NCT00397514|Primary|Cardiac Index||Baseline and after 20 minutes of pacing||||L/min/m2||Full Range|Median
1265037|NCT00397488|Primary|Overall Objective Response|Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria|2 years||||participants|||Number
1265038|NCT00397462|Secondary|Proximal Tibia Bone Density|Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)|One year||||percent change in bone density||Standard Error|Mean
1265039|NCT00397462|Primary|Bone Density of Proximal Femur|Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)|One year||||percent change in bone density||Standard Error|Mean
1265040|NCT00397254|Secondary|Adverse Experiences|Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Participants|||Number
1265417|NCT00395486|Secondary|Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal|Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.|Baseline and 6 weeks||||percentage of participants|||Number
1265041|NCT00397254|Secondary|Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose|Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Percentage of attacks|||Number
1265042|NCT00397254|Secondary|Percentage of Attacks With Symptom Elimination at 2 Hours|Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Percentage of attacks|||Number
1265043|NCT00397254|Secondary|Headache Severity of All Attacks|4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Units on a scale||Full Range|Median
1265044|NCT00397254|Secondary|Average Attack Duration||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Hours||Standard Deviation|Mean
1265045|NCT00397254|Secondary|Percentage of Responders|Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Percentage of Participants|||Number
1265046|NCT00397254|Secondary|Number of Migraine Attacks||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Migraine attacks||Standard Deviation|Mean
1265047|NCT00397254|Primary|Number of Days With Migraine||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Days||Standard Deviation|Mean
1265048|NCT00397215|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.|||Subjects|||Number
1265049|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Cells||Standard Deviation|Geometric Mean
1265050|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], interferon gamma [INF-g] and tumor necrosis factor-alpha [TNF-α].|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Cells||Standard Deviation|Geometric Mean
1265051|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (HEM), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents NEU, PLA, RBC, URE and WBC results.|At Days 0, 2, 21 and 23.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1265217|NCT00396266|Secondary|Single-dose Maximum Observed Concentration of Plerixafor (Cmax)|Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||ng/mL||Standard Deviation|Mean
1265052|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available|||Cells||Standard Deviation|Geometric Mean
1265053|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Cells||Standard Deviation|Geometric Mean
1265054|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents EOS, HEM, LDE, LYM and MON results.|At Days 0, 2, 21 and 23.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1265055|NCT00397215|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1265056|NCT00397215|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Note: The study period was divided into 4 consecutive periods (Days 0-51, Days 52-180 [Month 6], Months 6-12 and Months 12-24), for which SAEs were collected."|During the entire study period (Day 0 to Month 24).|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1265057|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT, AST, BAS, CREA and CRPH.|At Days 0, 2, 21 and 23|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1265058|NCT00397215|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.|||Subjects|||Number
1265059|NCT00397215|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|"An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.~Note: No AESIs were reported during the entire study period."|During the entire study period (Day 0 to Month 24)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, on a subset of subjects enrolled for this study in Belgium.||||||
1265060|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
1265105|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score|Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
1265061|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
1265062|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
1265063|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265064|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265065|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265066|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265067|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265068|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265069|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Fold||95% Confidence Interval|Geometric Mean
1265106|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score|Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
1265070|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Fold||95% Confidence Interval|Geometric Mean
1265071|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Fold||95% Confidence Interval|Geometric Mean
1265072|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265073|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265074|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
1265075|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
1265076|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
1265077|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titers||95% Confidence Interval|Geometric Mean
1265078|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subjects|||Number
1265142|NCT00396630|Secondary|Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.|"GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting.~RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA)."|Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.|The analyses were performed on the Total Vaccinated Cohort|||subjects|||Number
1265079|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subjects|||Number
1265080|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Days 0 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1265081|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subjects|||Number
1265082|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Fold||95% Confidence Interval|Geometric Mean
1265083|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1265084|NCT00397189|Secondary|The Change From Baseline in Subjective Sleep Maintenance.|Sleep maintenance as measured by number of awakening (NOA) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary (National sleep foundation sleep diary). The patients reported subjectively of their NOA. The Sleep Diary question 4 (NOA) was summarized at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used. Lower score indicates less awakenings and thus considered improvement.|3 weeks||||Awakenings||95% Confidence Interval|Mean
1265085|NCT00397189|Primary|The Change From Baseline in Subjective Sleep Latency.|Sleep latency (SL) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary (National sleep foundation sleep diary). The patients reported subjectively of their SL. The Sleep Diary question 3 (SL) was summarised at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used. Lower score indicates reduction in sleep latency and thus considered improvement|Baseline and 3 weeks|Pre-planned analysis on ITT population age 65-80|||minutes||Standard Deviation|Mean
1265086|NCT00397150|Primary|Exclusive Breastfeeding Rates in South Africa|The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT|||participants|||Number
1265087|NCT00397150|Primary|Exclusive Breastfeeding Rates in Uganda|The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT|||participants|||Number
1265088|NCT00397150|Secondary|Per Protocol Analysis of Infant Morbidity||at 3 months of age|||||||
1265089|NCT00397150|Secondary|Per Protocol Analysis of EBF Rates||at 3 months of age|||||||
1265090|NCT00397150|Secondary|Growth||(up to 6 months of age)|||||||
1265091|NCT00397150|Primary|Infant Morbidity, 2 Week Diarrhoea Prevalence||at 3 months of age||||participants|||Number
1265092|NCT00397150|Primary|Exclusive Breastfeeding Rates in Burkina Faso|The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT|||participants|||Number
1265093|NCT00397046|Primary|Maximum Tolerated Dose (MTD)|MTD is defined as the prior dose level of the dose level which has >=2 of 3 to 6 subjects that experience a neratinib-related DLT during 21 days from first dose date. A DLT is defined as any HKI-272-related nonhematologic grade 3 or any grade 4 AE according to the Common Terminology Criteria for Adverse Events version 3.0 except: Grade 3 nausea, vomiting, diarrhea, or rash unless subject was receiving appropriate medical therapy.|First dose date through 21 days|All subjects who received at least one dose.|||mg|||Number
1265143|NCT00396630|Secondary|Anti-rotavirus IgA Antibody Concentration.|Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.|At Visit 3 (Week 13).|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.|||U/mL||95% Confidence Interval|Geometric Mean
1265094|NCT00397046|Secondary|Clinical Benefit Rate|Subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), or Stable Disease (SD) >= 24 weeks, according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). SD is defined as SD in target lesions and a non-progressive disease (PD) in nontarget lesions; A PR is defined as either a PR in target lesions and a non-PD in nontarget lesions, or a CR in target lesions and an incomplete response or SD in nontarget lesions; and a CR is defined as a CR in target lesions and a CR in nontarget lesions.|From first dose date to progression/death or last assessment, up to 9.2 months.|Subjects who received at least 14 days of continual dose administration of drug and who had undergone at least 1 follow-up tumor assessment were considered evaluable for efficacy|||percentage of participants||95% Confidence Interval|Number
1265095|NCT00397046|Secondary|Objective Response Rate (ORR)|ORR is defined as the proportion of subjects who had either a complete response (CR) or partial response (PR), according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). The modified RECIST is defined as CR: Disappearance of all target lesions, PR: At least a 30% decrease in the sum of the Longest Diameters (LDs) of target lesions, taking as reference the baseline sum LDs. Response required confirmation.|From first dose date to disease progression or last tumor assessment, up to 9.2 months|Subjects who received at least 14 days of continual dose administration of drug and who had undergone at least 1 follow-up tumor assessment were considered evaluable for efficacy|||percentage of participants||95% Confidence Interval|Number
1265096|NCT00397046|Primary|Dose Limiting Toxicity (DLT)|DLT was defined as any drug-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, except the grade 3 nausea, vomiting, diarrhea, or rash, unless the subject was receiving appropriate medical therapy. Additional DLTs included the following: grade 2 or 3 diarrhea lasting 2 or more days for which the subject was receiving medical therapy or that was associated with fever or dehydration.|First dose date through 21 days|All subjects who received at least one dose.|||Participants|||Count of Participants
1265097|NCT00397033|Other Pre-specified|Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject’s report of his or her condition and clinician’s behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population with a baseline YMRS total score of >= 16.|||points on scale||Standard Deviation|Mean
1265098|NCT00397033|Other Pre-specified|Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject’s report of his or her condition and clinician’s behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline|Intent-to-Treat population with a baseline YMRS total score of >= 16.|||points on a scale||Standard Deviation|Mean
1265099|NCT00397033|Secondary|Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder|The CGI-C rating scale is a 7 point global assessment that measures the clinician’s impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to “No change”. Ratings of <4 are equivalent to “improvement” and ratings of > 4 are equivalent to “worsening”.|Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.|||points on a scale||Standard Deviation|Mean
1265100|NCT00397033|Primary|The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point|Intent-to-Treat population|||points on scale||Standard Deviation|Mean
1265101|NCT00397033|Secondary|Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder|The CGI-S rating scale is a 7 point global assessment that measures the clinician’s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to “Normal, not at all ill” and a rating of 7 is equivalent to “Among the most extremely ill subjects”.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.|||points on scale||Standard Deviation|Mean
1265102|NCT00397033|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline|The CGI-S rating scale is a 7 point global assessment that measures the clinician’s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to “Normal, not at all ill” and a rating of 7 is equivalent to “Among the most extremely ill subjects”.|Baseline|Intent-to-Treat population.|||points on a scale||Standard Deviation|Mean
1265103|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score|Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
1265104|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score|Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
1265144|NCT00396630|Secondary|Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.|Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.|At Visit 3 (Week 13).|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.|||subjects|||Number
1265107|NCT00397033|Other Pre-specified|Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16.|||points on scale||Standard Deviation|Mean
1265108|NCT00397033|Other Pre-specified|Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline|Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16.|||points on a scale||Standard Deviation|Mean
1265109|NCT00397033|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score|Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population.|||points on a subscale||Standard Deviation|Mean
1265110|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
1265111|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
1265112|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population.|||points on subscale||Standard Deviation|Mean
1265113|NCT00397033|Secondary|Number of Participants With Response|Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of <= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.|||count of participants|||Number
1265114|NCT00397033|Primary|Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|The Intent-to-Treat population included all randomized participants who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.|||points on a scale||Standard Deviation|Mean
1265115|NCT00396981|Secondary|Target Aneurysm Recurrence||5 years||||participants|||Number
1265116|NCT00396981|Secondary|Target Aneurysm Recurrence||3 years||||participants|||Number
1265117|NCT00396981|Secondary|Target Aneurysm Recurrence||2 years||||participants|||Number
1265118|NCT00396981|Secondary|Technical Procedure Success||Post-procedure||||percentage of participants|||Number
1265119|NCT00396981|Secondary|Neurological Assessments|"The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects same or better."|12 months||||percentage of participants|||Number
1265120|NCT00396981|Secondary|Angiographic Assessments|"Number of participants with angiographic assessment of complete obliteration."|Reintervention or 12 months||||participants|||Number
1265121|NCT00396981|Primary|Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.||12 months|A totoal of 630 subjects were planned for the study. All enrolled MAPS trial subjects' data is included in the ITT anaylsis except for four subjects who were excluded due to the following reasons: one subject did not have an aneurysm and three subjects', a the request of the IRB, due to non GCP compliance in obtaining the inofrmed consent.|||participants|||Number
1265122|NCT00396877|Secondary|Number of Participants According to Bleeding Type/Etiology|For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. Participants who had multiple bleedings could be counted several times.|From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first|The analysis was performed on the same population as previously (i.e. exposed population).|||participants|||Number
1265640|NCT00394654|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 27, 55, 84, and 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
1265123|NCT00396877|Secondary|Number of Participants With Bleeding Events|"Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.~The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted."|From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first|The analysis was performed on the exposed population (i.e. all randomized participants who received at least one dose of study drug regardless of the amount of treatment received). Participants were included in the treatment group according to the treatment received.|||participants|||Number
1265124|NCT00396877|Primary|Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)|"The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee.~Only the first event was counted."|Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)|The analysis was performed on the intent-to-treat (ITT) population (i.e. all randomized participants irrespective of whether or not the participant actually received study drug or the participant's compliance with the study protocol). Participants were included in the treatment group to which they were originally allocated.|||participants|||Number
1265125|NCT00396812|Primary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 48|ESR is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||mm/hr||Standard Deviation|Mean
1265126|NCT00396812|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 48|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). In addition, category scores are modified if an aid or device is used, for example, a walker or wheelchair, or help is received from another person in the daily living activities. If an aid or device is used or help is received then a category score of 0 or 1 increases to a category score of 2. A category score of 3 remains a 3 regardless of aids, devices, or help. Scores from each of the 8 categories are totaled. The total score can range from 0 to 24. Change from baseline is computed as the total score at Week 48 minus the baseline total score. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Units on a scale||Standard Deviation|Mean
1265127|NCT00396812|Primary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Units on a scale||Standard Deviation|Mean
1265128|NCT00396812|Primary|Change From Baseline in Physician’s Global Assessment of Patient’s Disease Activity- Visual Analog Scale (PhGADA-VAS) at Week 48|Change from Baseline in PhGADA-VAS (0 to 100 millimeters visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||mm||Standard Deviation|Mean
1265129|NCT00396812|Primary|Change From Baseline in Patient’s Global Assessment of Disease Activity- Visual Analog Scale (PtGADA-VAS) at Week 48|Change from Baseline in PtGADA-VAS (0 to 100 millimeters visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||mm||Standard Deviation|Mean
1265130|NCT00396812|Primary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 48|Change from Baseline in PAAP-VAS (0 to 100 millimeters visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||mm||Standard Deviation|Mean
1265131|NCT00396812|Primary|Change From Baseline in Swollen Joint Count at Week 48|Swollen Joint Count (SJC) is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 48 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Units on a scale||Standard Deviation|Mean
1265132|NCT00396812|Primary|Change From Baseline in Tender Joint Count Score at Week 48|Tender Joint Count (TJC) is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 48 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Units on a scale||Standard Deviation|Mean
1265641|NCT00394654|Secondary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
1265133|NCT00396812|Primary|Change From Baseline in the Disease Activity Score- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48|The DAS28-ESR is a score on a scale (0 to 10) that is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR (mm/hour). Lower score indicates less disease activity. Flares in disease activity are defined as an increase in this score of greater than 1.2 and remission is defined as achieving a DAS28-ESR score of less than 2.6.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Score on a scale||Standard Deviation|Mean
1265134|NCT00396656|Secondary|Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment|Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. Pulse wave velocity is the speed of the forward traveling wave and can be used as a measure of arterial stiffness since the more rigid the wall of the artery, the faster the wave moves.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Meters per second||Standard Deviation|Mean
1265135|NCT00396656|Secondary|Arterial Pressure Waveform Augmentation Index at the End of Treatment|Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. The augmentation index is the ratio of the first and second systolic peaks and is used as a surrogate measure of arterial stiffness.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Ratio||Standard Deviation|Mean
1265136|NCT00396656|Secondary|Mean Post-treatment Microcirculation at NaCl Injected Sites|10 µl of NaCl was injected intra-dermally at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Perfusion units||Standard Deviation|Mean
1265137|NCT00396656|Secondary|Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites|10 µl of sodium nitroprusside at a concentration of 10-7 M was injected intra-dermally at 1 site on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated and compared to the sodium nitroprusside mean. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Perfusion units||Standard Deviation|Mean
1265138|NCT00396656|Secondary|Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites|10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) plus 10 µl L-NMMA (10-6 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Perfusion units||Standard Deviation|Mean
1265139|NCT00396656|Primary|Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites|10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Perfusion units||Standard Deviation|Mean
1265140|NCT00396630|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Up to Visit 4.|The analyses were performed on the Total Vaccinated Cohort|||subjects|||Number
1265141|NCT00396630|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after any doses.|The analyses were performed on the Total Vaccinated Cohort|||subjects|||Number
1265145|NCT00396630|Secondary|Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.|Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.|During the entire study period (up to Visit 4, Week 17).|The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins who received placebo in case of transmission.|||Subjects|||Number
1265146|NCT00396630|Secondary|Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.|Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.|During the entire study period (up to Visit 4, Week 17).|The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins who received placebo and those who received Rotarix vaccine, in case of transmission.|||Genetic variation difference|||Number
1265147|NCT00396630|Secondary|Duration of Human Rotavirus (HRV) Shedding Per Study Group.|Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.|From Day 0 up to Week 13.|The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins whose placebo recipient had at least one stool sample positive for the rotavirus strain.|||Number of days||Inter-Quartile Range|Median
1265148|NCT00396630|Primary|Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.|Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.|On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.|||subjects|||Number
1265149|NCT00396591|Secondary|Safety - Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized|All participants who received at least part of 1 dose of the study treatment.|||participants|||Number
1265150|NCT00396591|Secondary|Number of Participants With a Positive Anti-drug Antibody Response|"Anti-drug antibodies in participant's serum were measured using 2 different methods~an Enzyme Linked Immunosorbent Assay (ELISA) in which the lower limit of detection (LLOD) was 238.4 ng/mL; and~an Electrochemiluminescence-based, Bridging Assay in which the validated LLOD was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.~Participants with detectable anti-drug antibodies by either method were considered to have a positive anti-drug antibody response."|up to 60 days after the last dose of treatment|Participants who received at least part of 1 dose of aflibercept and had evaluable blood samples|||participants|||Number
1265151|NCT00396591|Secondary|Overall Survival (OS) Time|OS time was the time interval between the date of registration to the date of death from any cause. Median OS was estimated from Kaplan-Meier curves. Participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.|up to 6 months post-registration|All participants were analyzed. 5 participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.|||days|Participants|95% Confidence Interval|Median
1265152|NCT00396591|Secondary|Progression-free Survival (PFS) Time|"According to the Response Evaluation Criteria in Solid Tumors [RECIST], progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.~PFS time was interval from the date of registration to the date of tumor progression or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~If participants were alive and progression-free at 6 months postregistration, they were censored for PFS."|up to 6 months post-registration|Participants with a PFS event (tumor progression or death) were analyzed.|||days||95% Confidence Interval|Median
1265153|NCT00396591|Secondary|60-day Frequency of Paracentesis (FOP)|FOP was the total number of paracenteses performed within the first 60 days postregistration. For participants who had withdrawn after registration but prior to the 60-day cutoff date, the withdrawal would have been regarded as a paracentesis event and the 60-day FOP normalized and calculated as the nearest integer of the value corresponding to 60 × number of paracenteses / x, where x represents the number of days on study.|up to 60 days post-registration||||paracenteses||Standard Deviation|Mean
1265154|NCT00396591|Secondary|Time to Repeat Paracentesis (TRP)|TRP is the number of days between the date of registration and the date of the first postregistration paracentesis. Median TRP was estimated from Kaplan-Meier curves. For participants who did not undergo a postregistration paracentesis while on study, TRP was censored at the end of the treatment period (last dose + 1 cycle), at the last visit known without repeat paracentesis, at 6 months postregistration, or at death, whichever was earlier.|up to 6 months from registration|All participants were analyzed. 8 had one or more paracentesis events. Participants with no paracentesis events were censored at the end of the treatment period (last dose + 1 cycle).|||days|Participants|95% Confidence Interval|Median
1265155|NCT00396591|Primary|Percentage of Participants With a Repeat Paracentesis Response (RPR)|"RPR was defined as at least a two-fold increase in the time to repeat paracentesis (TRP) as compared to the average duration of the 2 intervals between the 3 most recent paracenteses prior to study registration (ie, the baseline interval of paracentesis).~Percentage of participants with a repeat paracentesis response were the number of participants with RPR / number of total participants * 100."|up to 2 years post-registration||||percentage of participants||95% Confidence Interval|Number
1265156|NCT00396565|Secondary|Change From Baseline in Clinical Global Impression Scale (CGI-S)|The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 – Not ill, 2 – Very Mild, 3 – Mild, 4 – Moderate, 5 – Marked, 6 – Severe, and 7 – Extremely Severe.|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Error|Mean
1265457|NCT00395291|Secondary|Change in CRPs After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the CRPs levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions.|||mg/ml||Standard Deviation|Mean
1265157|NCT00396565|Secondary|Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])|Responders are subjects with 30% or more reduction from baseline in total PANSS score. PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||Percentage of participants|||Number
1265158|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Deviation|Mean
1265159|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Deviation|Mean
1265160|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Deviation|Mean
1265161|NCT00396565|Primary|Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine (OLZ) group was set as an active drug group to examine clinical position of paliperidone (PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Deviation|Mean
1265162|NCT00396409|Secondary|Lung Function as Assessed by Peak Expiratory Flow (PEF)|The spirometric parameter Peak Expiratory Flow (PEF) was measured during grass pollen season before each injection of Depigoid. PEF was collected in the patient diary at seven days after visit 22, 23 and 24 as well as 35, 36 and 37. For analyzing purposes these data were averaged after the respective visits. Missing PEF-values from the patient diary were not replaced.|Assist during 2007 and 2008 pollen season|Intent-to-Treat (ITT)|||liters per minute (L/min)||Standard Deviation|Mean
1265163|NCT00396409|Secondary|Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)|The spirometric parameter Forced Expiratory Volume in One Second (FEV1) was measured during grass pollen season before each injection of Depigoid.|Assist during 2007 and 2008 pollen season|Intent-to-Treat (ITT)|||milliliters (mL)||Standard Deviation|Mean
1265164|NCT00396409|Secondary|Work Productivity and Activity Impairment|The Work Productivity and Activity Impairment questionnaire measures time missed from work, impairment of work and regular activities. It consists of 6 items. The outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The minimum value is 0 (0 %), the maximum value is 1 (100%). The recall time is 1 week. For this study WPAI-AA was used defining the specific health problem as allergic asthma, which has been validated by the instrument owner.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
1265165|NCT00396409|Secondary|Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline|Both the AQLQ and RQLQ clinical differences were categorized as important, moderate, or meaningful improvement; no clinical change; meaningful, moderate, or important impairment. Clinically important differences in scores between any two assessments have been determined by the authors of the AQLQ and RQLQ. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||participants|||Number
1265166|NCT00396409|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinoconjunctivitis. It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions). Patients recall their experiences during the previous week and to score each item on a 7-point scale. The overall RQLQ score is the mean response to all 28 questions (low=1, high=7). Higher values represent worse quality of life.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
1265259|NCT00396084|Secondary|Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC) Adjusted for Free Drug Concentrations||Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/ml||Inter-Quartile Range|Median
1265167|NCT00396409|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains (symptoms, emotions, exposure to environmental stimuli and activity limitation). Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions (low=1, high=7). Higher values represent better quality of life.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
1265168|NCT00396409|Secondary|Asthma Control Questionnaire (ACQ)|The Asthma Control Questionnaire (ACQ) was developed and validated for assessing asthma symptom control in patients in clinical trials as well as for individuals in clinical practice. It is a simple questionnaire consisting of seven questions assessing symptoms, airway caliber and rescue β2-agonist use. It uses a 7-point scale. The possible minimum value is 1, the possible maximum value is 7. Higher values represent worse asthma control and quality of life, respectively.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
1265169|NCT00396409|Secondary|Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient|The patient's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1=’excellent’, 2=’good’, 3=’moderate’, 4=’poor’, 5=’worsening’ and (.)=’missing’).|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||percentage of participants|||Number
1265170|NCT00396409|Secondary|Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator|The investigator's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1=’excellent’, 2=’good’, 3=’moderate’, 4=’poor’, 5=’worsening’ and (.)=’missing’).|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||percentage of participants|||Number
1265171|NCT00396409|Secondary|Asthma/Rhinoconjunctivitis Rescue Medication Score|Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient’s entries in their diaries.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
1265172|NCT00396409|Secondary|Asthma/Rhinoconjunctivitis Symptom Severity Score|The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
1265173|NCT00396409|Primary|Daily Symptom Load|The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT). The complete analysis population who consisted of all patients that received at least one dose of study drug was used for all efficacy and safety evaluations in this extension period.|||units on a scale||Standard Deviation|Mean
1265174|NCT00396383|Post-Hoc|Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg|Number of participants achieving ≥ 2*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Total was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.|Day 1 up to day 4|All participants who received plerixafor|||participants|||Number
1265175|NCT00396383|Secondary|Number of Participants With a Durable Graft at 12 Months Post Transplantation|Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.|Approximately month 13|Intent to treat population includes participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant.|||participants|||Number
1265176|NCT00396383|Secondary|Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment|Platelet (PLT) engraftment was defined as a PLT count of ≥ 20*10^9/L for 7 days without transfusion. Days to engraftment corresponded to the first day that the criteria were met after transplantation.|Approximately 2 months|Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants. One participant did not have PLT samples collected (included as 'unknown' in data table).|||transplantations|Participants||Number
1265177|NCT00396383|Secondary|Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment|Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1*10^9/L for 1 day. Days to engraftment corresponded to the first day that the criteria were met after transplantation.|Approximately 2 months|Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants.|||transplantations|Participants||Number
1265274|NCT00396084|Secondary|Sputum Cytokine Proteins - Results Are Pending.||Study drug administration duration|||||||
1265275|NCT00396084|Secondary|Sputum mRNA Clearance Rate - Results Are Pending.||Study drug administration duration|||||||
1265178|NCT00396383|Primary|Participant Counts of Summarized Adverse Events (AE) During Treatment|Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).|1 month|All participants who received plerixafor|||participants|||Number
1265179|NCT00396383|Primary|Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg|Number of participants achieving a target of ≥ 4*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.|Day 1 up to day 4|All participants who received plerixafor|||participants|||Number
1265180|NCT00396331|Secondary|Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 7|Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.|Days 7-8 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||ng*h/mL||Standard Deviation|Mean
1265181|NCT00396331|Secondary|Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 4|Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.|Days 4 -5 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||ng*h/mL||Standard Deviation|Mean
1265182|NCT00396331|Secondary|Time to Maximum Plasma Concentration (Tmax) on Day 7|Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data|Day 7 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||Hours||Full Range|Median
1265183|NCT00396331|Secondary|Time to Maximum Plasma Concentration (Tmax) on Day 4|Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data|Day 4 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||Hours||Full Range|Median
1265184|NCT00396331|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 7|Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.|Day 7 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||ng/mL||Standard Deviation|Mean
1265185|NCT00396331|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 4|Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.|Day 4 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||ng/mL||Standard Deviation|Mean
1265186|NCT00396331|Secondary|Number of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF|Number of participants who had at least 5*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.|Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)|Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.|||Participants|||Number
1265187|NCT00396331|Secondary|Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF|Number of participants who had at least 2*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.|Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)|Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.|||Participants|||Number
1265188|NCT00396331|Secondary|Number of Participants With Non-Hodgkin's Lymphoma (NHL) Who Had Evidence of Tumor Cell Mobilization After G-CSF or Plerixafor Administration|The number of participants with Bcl2 translocation in post-treatment samples.|Up to Day 7|"NHL participants with known follicular or transformed (follicular to diffuse large cell) lymphoma who provided samples for tumor cell mobilization analysis.~Outcome is not reported because there were insufficient samples for analysis."||||||
1265189|NCT00396331|Primary|Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|Proportion of participants who reached the target of at least 5*10^6 CD34+ cells/kg collected during up to 7 apheresis.|Day 5 to Day 11 (up to 7 aphereses)|Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had two courses of apheresis.|||Proportion of Participants|||Number
1265190|NCT00396331|Secondary|Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation|The number of participants maintaining a durable graft 12 months after transplantation. A durable graft was defined as maintenance of normal blood counts: PLT >50*10^9/L without transfusion for at least 2 weeks prior to the visit; hemoglobin level >= 10 g/dL with no erythropoietin or transfusions for at least 1 month prior to the visit; and absolute neutrophil count (ANC) > 1,000 (1*10^9/L) with no G-CSF for at least 1 week prior to the visit.|Approximately 13 months (12 months post transplant )|Participants who received autologous stem cell transplantation and were evaluable 12 months post transplant. The 3 participants who did not have durable grafts included 2 participants whose PLT level never recovered to >50*10^9/L and 1 who had low hemoglobin at the 12-month visit.|||Participants|||Number
1265203|NCT00396292|Primary|Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin||anytime between baseline and the end of study or time to intervention|Modified Intent to Treat Population defined as subjects who received at least 1 dose of randomized study medication, had at least 1 post-baseline hemoglobin assessment, and had postpartum anemia characterized by an average of the 2 baseline central laboratory hemoglobin being <11.0 g/dL|||participants|||Number
1265191|NCT00396331|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The number of days from transplantation to successful engraftment as measured by platelet value of >=20*10^9/L for 7 days without transfusion.|Approximately 2 months (1 month post transplant)|Participants who received a transplant and had a successful PLT engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Four transplants (2 in participants with NHL and 2 in participants with MM) did not result in PLT engraftment and are therefore not included in the analysis.|||Days|Participants|Full Range|Median
1265192|NCT00396331|Secondary|Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|The number of days from transplantation to successful engraftment as measured by PMN >=0.5*10^9 /L for 3 days or >=1.0*10^9 /L for 1 day.|approximately 2 months (1 month post transplant)|Participants who received a transplant and had a successful PMN engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Two transplants (1 in a participant with NHL and 1 in a participant with MM) did not result in PMN engraftment and are therefore not included in the analysis.|||Days|Participants|Full Range|Median
1265193|NCT00396331|Primary|Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|Proportion of participants who reached the target of at least 2*10^6 CD34+ cells/kg collected during up to 7 aphereses.|Day 5 to Day 11 (up to 7 apheresis)|Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had 2 courses of apheresis.|||Proportion of Participants|||Number
1265194|NCT00396331|Primary|Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period|Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately day 38|Safety population of all participants who received at least 1 dose of plerixafor.|||Participants|||Number
1265195|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 7 days post-treatment|Number of patients (from MITT population) with restored CVC function during the treatment period|||percentage of participants|||Number
1265196|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 120 minutes post-treatment (Dose 1 or Dose 2)|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265197|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after second dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265198|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after second dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265199|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after second dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265200|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265201|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265202|NCT00396318|Primary|Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265411|NCT00395486|Secondary|Percentage Change of High-Density Lipoprotein-C (HDL-C)|Calculate the percentage change of HDL-C level|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
1265205|NCT00396279|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.|From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months|All participants who received at least 1 dose of denosumab.|||participants|||Number
1265206|NCT00396279|Secondary|Serum Denosumab Trough Concentrations|Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.|The pharmacokinetics analysis set included participants who received at least 1 dose of denosumab and for whom at least 1 serum denosumab trough concentration was available. 'n' indicates the number of participants with available data at each time point.|||ng/mL||Standard Deviation|Mean
1265207|NCT00396279|Secondary|Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)|Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.|Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81|Efficacy Analysis Set with available data at each time point (n).|||percent change||Inter-Quartile Range|Median
1265208|NCT00396279|Secondary|Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine|Urinary N-telopeptide (of type 1 collagen) corrected for urine creatinine (uNTX/Cr) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in uNTX/Cr was measured over time.|Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81|Efficacy Analysis Set with available data at each time point (n).|||percent change||Inter-Quartile Range|Median
1265209|NCT00396279|Primary|Percentage of Participants With Giant Cell Tumor Response|A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent < 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.|From enrollment until 25 weeks|The efficacy analysis set included participants with a Baseline histology assessment and at least 1 postdose histology assessment from weeks 5-25; or a Baseline radiology assessment and at least 1 postdose radiology assessment from weeks 5-25. Evaluable participants had to be on study for at least 28 days after administration of the first dose.|||percentage of participants||95% Confidence Interval|Number
1265210|NCT00396266|Secondary|Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor|A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor).|Day 4 (10 hours post first plerixafor dose)|Pharmacodynamic analysis was performed on a subgroup of participants from both treatment arms (1 NHL and 3 MM). The maximum fold increase was observed at 10 hours for all participants.|||ratio||Full Range|Median
1265211|NCT00396266|Secondary|Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients|Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||mL||Standard Deviation|Mean
1265212|NCT00396266|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population - all participants who received at least 1 dose of plerixafor.|||participants|||Number
1265213|NCT00396266|Secondary|Single-dose Apparent Clearance of Plerixafor (CL/F)|Evaluation of Cl/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cl/F was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||mL/hour||Standard Deviation|Mean
1265214|NCT00396266|Secondary|Single-dose Area Under the Concentration-time Curve of Plerixafor From Time 0 to 10 Hours Post-dose (AUC0-10)|Evaluation of AUC0-10 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. AUC0-10 was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||ng•h/mL||Standard Deviation|Mean
1265215|NCT00396266|Secondary|Single-dose Half-life of Plerixafor (T1/2)|Evaluation of T1/2 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. T1/2 was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||hours||Standard Deviation|Mean
1265216|NCT00396266|Secondary|Single-dose Time to Maximum Concentration of Plerixafor (Tmax)|Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data.|Day 5 - 0 to 10 hours post-first plerixafor dose|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||hours||Full Range|Median
1265218|NCT00396266|Secondary|Tumor Cell Mobilization in Non-Hodgkin's Lymphoma (NHL) Participants Following Plerixafor Treatment|In a subpopulation of NHL participants, the mobilization of NHL cells was to be evaluated. None of the samples were analyzed due to sample degradation.|Prior to the first (Day 4) and last dose of plerixafor, immediately prior to each apheresis, and 24 hours after the last apheresis.|This analysis was not performed due to sample degradation.||||||
1265219|NCT00396266|Secondary|Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Intent to treat population of participants who had transplants. One participant received a tandem transplant.|||number of transplants|Participants||Number
1265220|NCT00396266|Secondary|Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells|To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor.|Time 0 to 11 hours after the first dose of plerixafor|"The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).~One participant excluded from the analysis because data was missing."|||participants|||Number
1265221|NCT00396253|Secondary|Change in Blood Flow Rate From Baseline to the End of HD at Visit 2|Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 2 – BFR at Baseline.|Baseline (beginning of HD at Visit 1) to the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1).|Subjects in the MITT Population Treated with Extended-Dwell Tenecteplase at Visit 1|||mL/minute||Standard Deviation|Mean
1265222|NCT00396253|Secondary|Percentage of Participants Who Failed Treatment at Visit 1 With a Urea Reduction Ratio ≥ 65% at Visits 2 and 3|"Patients who experienced treatment failure at the end of Visit 1 and were eligible for and treated with extended-dwell tenecteplase at Visit 1 were assessed for Urea Reduction Ratio (URR) at Visits 2 and 3. URR was calculated from blood urea nitrogen (BUN) measurements according to the following:~(Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)"|Blood urea nitrogen measurements were taken prior to HD and at the end of HD at Visits 2 (2nd HD session, within 72 hours after visit 1) and 3 (3rd HD session, within 72 hours of Visit 2)|Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.|||percentage of participants||95% Confidence Interval|Number
1265223|NCT00396253|Secondary|Percentage of Participants Who Failed Treatment at Visit 1 With Treatment Success at Visit 2|Patients who failed treatment at Visit 1 and were treated with extended-dwell tenecteplase were analyzed for Treatment Success at Visit 2. Treatment success at Visit 2 was defined as a BFR ≥ 300 mL/min, without line reversal, and increase of ≥ 25 mL/min from baseline BFR, at an associated target arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of HD and at the end of HD.|BFR was measured 30 minutes before the end of HD and at the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1). Baseline BFR was measured at the beginning of HD at Visit 1.|Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.|||percentage of participants||95% Confidence Interval|Number
1265224|NCT00396253|Secondary|Change in Blood Flow Rate From Baseline to the End of Hemodialysis at Visit 1|Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 1 – BFR at Baseline.|Baseline (beginning of HD at Visit 1) to the end of HD at Visit 1.|Modified intent to treat (MITT) population|||mL/min||Standard Deviation|Mean
1265225|NCT00396253|Secondary|Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 2|"The urea reduction ratio (URR) at Visit 2 was calculated for those participants who did not receive extended-dwell tenecteplase at Visit 1 from measurements of blood urea nitrogen (BUN) as follows:~(Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)"|At Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) samples for blood urea nitrogen measurements were taken prior to HD and after HD was completed.|Modified intent to treat (MITT) population who did not receive extended-dwell tenecteplase at Visit 1.|||percentage of participants||95% Confidence Interval|Number
1265226|NCT00396253|Secondary|Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 1|"The urea reduction ratio (URR) was calculated from measurements of blood urea nitrogen (BUN) as follows:~(Pre-treatment BUN) − (Post-HD BUN) * 100% / (Pre-treatment BUN)~Pre-treatment URR was assessed within 30–60 minutes after the initiation of HD and does not represent a true baseline value."|At Visit 1 (first hemodialysis session in which treatment was administered) samples for blood urea nitrogen measurements were taken at the beginning of HD (prior to treatment administration) and after HD was completed.|Modified intent to treat (MITT) population|||percentage of participants||95% Confidence Interval|Number
1265227|NCT00396253|Secondary|Percentage of Participants Who Maintained Catheter Function at Visits 2 and 3|For patients with treatment success at Visit 1 or Visit 2, maintenance of catheter function at subsequent visits was defined as a BFR ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated target arterial pressure in the range of 0 to -280 mmHg at the beginning of that HD session (within the first 30 minutes).|Maintenance BFR measurements were taken at the beginning of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) and Visit 3 (3rd consecutive HD session, within 72 hours of Visit 2).|Modified intent to treat (MITT) population, who had treatment success at Visit 1. The n equals the number of subjects who had treatment success at Visit 1 and had assessment of catheter function for the given visit or who had a missing assessment due to starting the Retreatment course.|||percentage of participants||95% Confidence Interval|Number
1265228|NCT00396253|Primary|Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase|The primary outcome measure was the number of targeted adverse events, occurring from initial study drug administration through the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for subjects who did not receive open-label, extended-dwell tenecteplase, from initial study administration through the start of Visit 2. Targeted adverse events were defined as intracranial hemorrhage, major bleeding and embolic events, thrombosis, Catheter-related blood stream infection (CRBSIs), and catheter-related complications.|From initial study drug administration to the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for patients who did not receive extended-dwell tenecteplase, from initial study administration to the start of Visit 2.|Modified intent to treat (MITT) population|||Events|||Number
1265229|NCT00396253|Primary|Percentage of Participants Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1|Treatment success is defined as Blood Flow Rate (BFR) ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of hemodialysis and at the end of hemodialysis.|Visit 1 (the first hemodialysis session in which treatment was administered). BFR was measured at the beginning of hemodialysis (Baseline measurement) and at 30 minutes prior to the end of hemodialysis and at the end of hemodialysis.|Modified intent to treat (MITT) population, consisting of all enrolled patients who received at least one dose of study drug (tenecteplase).|||Percentage of participants|||Number
1265230|NCT00396201|Secondary|Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor|The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||mL||Standard Deviation|Mean
1265231|NCT00396201|Secondary|Apparent Clearance (CL/F) of Single-dose Plerixafor|Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf).|Day 4-5|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||mL/hr||Standard Deviation|Mean
1265232|NCT00396201|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor|Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor.|Days 4-5|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||ng*hr/mL||Standard Deviation|Mean
1265233|NCT00396201|Secondary|Half-life (T1/2) Following a Single Dose of Plerixafor|Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||hours||Standard Deviation|Mean
1265234|NCT00396201|Secondary|Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor|Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||hours||Standard Deviation|Mean
1265235|NCT00396201|Secondary|Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor|Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||ng/mL||Standard Deviation|Mean
1265236|NCT00396201|Secondary|Number of Participants With a Durable Graft at 12 Months|Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment.|13 months|Intent to treat population which included all participants who received plerixafor and had a transplant.|||participants|||Number
1265237|NCT00396201|Secondary|Number of Days Post Transplantation to Platelet (PLT) Engraftment|Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met.|Up to Month 13 (up to 12 months post transplant)|Intent to treat population which included all participants who received plerixafor and had a transplant. One participant's time to engraftment was unknown due to missing lab values.|||days||Full Range|Median
1265238|NCT00396201|Secondary|Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment|Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13 (up to 12 months post transplant)|Intent to treat population which included all participants who received plerixafor and had a transplant.|||days||Full Range|Median
1265239|NCT00396201|Secondary|Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg|Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data.|Day 5 up to day 9|Intent to treat population which included all participants who received plerixafor and achieved a target of ≥5*10^6 CD34+cells/kg|||participants|||Number
1265240|NCT00396201|Secondary|Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL|The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population which included all participants who received plerixafor and had pre- and post-plerixafor CD34+ cell counts available; 3 participants had missing results data and were not included.|||ratio||Standard Deviation|Mean
1265241|NCT00396201|Secondary|Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories.|Day 5 up to day 9|Intent to treat population which included all participants who received plerixafor.|||proportion of participants|||Number
1265258|NCT00396084|Secondary|Area Under the Curve (AUC) During First 12 and 24 Hours Adjusted for Free Drug Concentrations|Median pharmacodynamic parameters (range) adjusted for free drug concentrations. AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/h/ml||Inter-Quartile Range|Median
1265242|NCT00396201|Secondary|Overall Participant Counts of Adverse Events During the Treatment Period|"Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant.~See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious."|Day 0 - approximately day 38|Safety population consisting of all participants who received G-CSF and/or plerixafor.|||participants|||Number
1265243|NCT00396201|Primary|Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.|Day 5 up to Day 9|Intent to treat population which included all participants who received plerixafor.|||proportion of participants|||Number
1265244|NCT00396162|Secondary|Mean Number of Days of Steroid Spray Use for Each Group||8 weeks||||days||Standard Deviation|Mean
1265245|NCT00396162|Secondary|Mean Number of Days of Antibiotic Use During the Study Period (0-8 Weeks)|Mean number of days that antibiotics were used in the subgroup (placebo vs Probiotic arm)|At 8 weeks after baseline measures||||days||Standard Deviation|Mean
1265246|NCT00396162|Secondary|Side Effect Summary|Totals of all side effects for placebo group and treatment group over the course of the eight week trial (including patients who dropped from the study after baseline measurement). Individual categories of side-effects are listed in Adverse events section.|8 weeks|The sample size on the placebo side is reduced due to some study participants not reporting their 8 week survey|||participants|||Number
1265247|NCT00396162|Primary|Mean Reduction in SNOT-20 Scores|Mean reduction (and Standard deviation) in SNOT-20 scores, from baseline to 8 week measurements. SinoNasal Outcome Test measures symptom severity. It is a summary score, ranging from 0 to 100 with 100 indicating worse symptoms. Since 100 represents more severe symptoms, the changes represented here are reductions in SNOT-scores, even though they are not expressed as negative numbers.|8 weeks||||units on a scale||Standard Deviation|Mean
1265248|NCT00396136|Primary|Safety of the COROX OTW Steroid LV Pacing Lead|Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.|3 years post implant|All study participants.|||participants|||Number
1265249|NCT00396136|Primary|Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing|Evaluate threshold voltage of the COROX OTW Unipolar Lead.|All follow-ups for 3 years post implant|All study participants.|||Threshold Voltage|Participants|Standard Deviation|Mean
1265250|NCT00396097|Secondary|Change From Baseline in Height SDS at 48 Months.|Change in height SDS was measured at 48 months.|4 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.|||Standard Deviation Score (SDS)||Standard Deviation|Mean
1265251|NCT00396097|Secondary|Estimated Cost of Height Gain Estimated Until Full Adult Height (FAH) at 48 Months|The estimated cost of long-term height gain until FAH was calculated.|4 years|Full analysis set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.|||mg/cm||Standard Deviation|Mean
1265252|NCT00396097|Secondary|Computed Cost of Height Gain at 48 Months|The computed cost of height gain was defined as the amount of drug used relative to the observed height-gain, in terms of mg/cm, this was calculated at Month 48.|4 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.|||mg/cm||Standard Deviation|Mean
1265253|NCT00396097|Secondary|Time Cost (Months Until >= -2 SDS)|Time cost was defined as the number of months needed until height SDS was within the normal limit (ie, >= -2SDS).|2 years|Full analysis set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available.|||Months||95% Confidence Interval|Median
1265254|NCT00396097|Secondary|Variability of Height SDS at 24 Months|The continuous endpoint of variability of height SDS at 24 months was defined as the SD of the 24 month height SDS.|2 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.|||Standard Deviation Score (SDS)||Standard Deviation|Mean
1265255|NCT00396097|Primary|Absolute On-target Difference (AOTD) at 24 Months|This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or –1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender).|2 years|The Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. Last observation carried forward (LOCF) rule was applied to impute Month 24 missing height SDS data.|||Standard Deviation Score (SDS)||Standard Deviation|Mean
1265256|NCT00396084|Secondary|Percent Dosing Interval Above Minimum Inhibitory Concentration (MIC)|Determined by linear extrapolation of concentration-versus-time curve to intersection with MIC.|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||Percentage||Inter-Quartile Range|Mean
1265257|NCT00396084|Secondary|Area Under the Curve (AUC) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC)|Area Under the Curve 0-12 (AUC 0-12) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC) and AUC 0-24/MIC|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/h/ml||Inter-Quartile Range|Median
1265412|NCT00395486|Secondary|Percentage Change of Total Cholesterol (TC)|Calculate the percentage change of total cholesterol level|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
1265260|NCT00396084|Secondary|Maximum Plasma Drug Concentrations (Cmax), Adjusted for Free Drug Concentration|Cmax adjusted for free drug concentrations after 5 days of monotherapy with study drugs|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/ml||Full Range|Median
1265261|NCT00396084|Secondary|Pharmacokinetic Parameters: Area Under the Curve During First 12 and 24 Hours|Median pharmacokinetic parameters (range). AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/h/ml||Full Range|Median
1265262|NCT00396084|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) and Half-life||Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||hours||Full Range|Median
1265263|NCT00396084|Secondary|Maximum Plasma Drug Concentration (Cmax)|Maximum Plasma Drug Concentration (Cmax), given sampling scheme|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/ml||Full Range|Median
1265264|NCT00396084|Secondary|Area Under the Curve During First 12 or 24 Hours / Minimum Inhibitory Concentration (AUC/MIC)|Area Under the Curve (AUC) During First 12 or 24 Hours /Minimum Inhibitory Concentration. AUC reflects total drug (bound and unbound). MIC values were determined using protein-containing media.|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling|||ug/ml||Inter-Quartile Range|Median
1265265|NCT00396084|Secondary|Pharmacokinetic Parameters: Area Under the Curve (AUC) During First 12 and 24 Hours|Area under the curve (AUC), from time 0-12 hours for INH or 0-24 hours for gatifloxacin, levofloxacin, and moxifloxacin.|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.|||ug/h/ml||Full Range|Median
1265266|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Linezolid Once Daily/Linezolid Twice Daily/INH Comparison|The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.|Day 2 to Day 7 Monotherapy|One patient in the INH arm discontinued the study drug after 5 days. Days 3 and 7 cultures for another patient in the INH arm were contaminated and cfu data are not available for this patient. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||log10 cfu/ml||Standard Deviation|Mean
1265267|NCT00396084|Secondary|Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC)||Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.|||ug/ml||Inter-Quartile Range|Median
1265268|NCT00396084|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) and Half-life||Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.|||hours||Full Range|Median
1265269|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Linezolid Once Daily/Linezolid Twice Daily/Isoniazid (INH) Comparison|Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum cfu (expressed in log10 units) during the first 2 days of monotherapy. Mean values for the 3 treatment groups were compared.|Day 0 to Day 2 Monotherapy|EBA 0-2 comparisons across groups were done for 29 patients. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||log10 cfu/ml/day||Standard Deviation|Mean
1265270|NCT00396084|Primary|Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)|The adjusted area under the curve (aAUC) for sputum colony forming unit (cfu) for each day on treatment was calculated for patients in the INH arm and those in the Linezolid once daily and Linezolid twice daily arms. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.|Study drug administration duration - 7 days monotherapy|The aAUC was calculated for 29 patients. One patient in the linezolid twice daily arm withdrew after randomization before receiving any doses of study drug.|||Percentage||Standard Deviation|Mean
1265271|NCT00396084|Primary|Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Fluoroquinolones/Isoniazid (INH) Comparison|The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.|Day 2 to Day 7 Monotherapy|A total of 38 patients were analyzed for Early Bactericidal Activity (EBA) Days 2-7. One patient in the moxifloxacin arm discontinued the study drug after 4 days. One patient in the INH arm discontinued the study drug after 6 days.|||log10 cfu/ml/day||Standard Deviation|Mean
1265272|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Fluoroquinolones/Isoniazid (INH) Comparison|Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum colony forming units (cfu) (expressed in log10 units) during the first 2 days of monotherapy.|Day 0 to Day 2 Monotherapy|Early bactericidal activity (EBA 0-2) was calculated for 10 subjects per treatment arm (n=40).|||log10 cfu/ml/day||Standard Deviation|Mean
1265273|NCT00396084|Secondary|Maximum Plasma Drug Concentration (Cmax)|Maximum plasma concentration, given sampling scheme|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.|||ug/ml||Full Range|Median
1265276|NCT00396084|Primary|Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)|The adjusted area under the curve (aAUC) for sputum colony forming units (cfu) for each day on treatment was calculated. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.|Study drug administration duration - 7 days monotherapy|The aAUC was calculated for 10 subjects per treatment arm (n=40).|||Percentage||Standard Deviation|Mean
1265277|NCT00396032|Secondary|Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 2 of consecutive HD treatments|MITT population with open-label tenecteplase at Visit 2|||percentage of success|||Number
1265278|NCT00396032|Secondary|Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 2 of consecutive HD treatments|MITT population with extended-dwell tenecteplase at Visit 1|||percentage of success|||Number
1265279|NCT00396032|Secondary|Change in BFR From Baseline to the End of HD at Visit 1|BFR is measured in mL/minute.|Visit 1 of HD treatment|MITT population|||percentage of participants|||Number
1265280|NCT00396032|Primary|Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2|Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications|Visits 1 and 2 of consecutive HD treatments|MITT population|||percentage of participants|||Number
1265281|NCT00396032|Primary|Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 1 of HD treatment|Modified intent to treat (MITT) population|||percentage of success|||Number
1265282|NCT00396019|Secondary|Number of Participants With Imaging Response in Stratum 3|"A Response was defined as a ≥ 20% reduction in the sum of the volume of the target plexiform neurofibroma (PN) within 12 months, confirmed by a follow-up MRI after ≥ 24 weeks"|MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study|Not Specified|||participants|||Number
1265283|NCT00396019|Primary|Time to Progression (TTP) in Stratum 3|TTP was estimated by the Kaplan-Meter method|baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study|Only participants in Stratum 3 contributed data for this Outcome Measure|||months||Full Range|Median
1265284|NCT00396019|Primary|Clinical Response in Stratum 2|Clinical response was defined as a protocol-specified improvement in ophthalmologic evaluation, an improvement of at least one level in performance status (PS) ≥50% decrease in the amount of pain medications required per week compared with baseline or ability to change from a narcotic to a nonnarcotic analgesic, sustained for at least one month.|baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study|Only participants in Stratum 2 contributed data for this Outcome Measure|||participants|||Number
1265285|NCT00396019|Primary|Number of Participants With Imaging Response in Strata 1 and 2|"A response was defined as a ≥20% reduction in the sum of the volume of the target plexiform neurofibroma ( PN) within 12 months confirmed by a follow-up MRI after ≥4 weeks."|MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study.|Not specified|||participants|||Number
1265286|NCT00396006|Secondary|Clinically Significant Changes in Vital Signs From Pre- to Post-Infusion|"Clinically significant changes in vital signs from pre- to post-infusion are:~Heart rate: 25% increase above pre-infusion value~Blood pressure: ≥ 30 mm Hg change from pre-infusion blood pressure (systolic or diastolic)~Temperature: an increase in body temperature to >38°C (>100.4°F). If the pre-infusion body temperature was already >38°C (>100.4°F), then any further increase in body temperature by 1.1°C (1.98°F) or more was considered clinically significant.~Respiratory rate: 25% increase above pre-infusion value"|During 8 consecutive weeks of infusion|Intention to treat|||# Clinically significant events|||Number
1265287|NCT00396006|Primary|Number of Changes in the Rate of Infusion|Number of decreases in the rate or discontinuations of infusion at 0.2 mL/kg/min|During 8 consecutive weeks of treatment||||infusions|||Number
1265288|NCT00396006|Other Pre-specified|Change in the BAL ELF Tumor Necrosis Factor-alpha (TNF-α) From Baseline to Post-treatment|Median change in the BAL ELF TNF-α from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol population with both pre- and post-treatment analytes available from BAL procedures||||||
1265289|NCT00396006|Other Pre-specified|Ratio of Post- to Pre-treatment BAL ELF Interleukin 8 (IL-8) Level|Median ratio of post- to pre-treatment BAL ELF IL-8 Level|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol|||pg/mL||Full Range|Median
1265290|NCT00396006|Other Pre-specified|Ratio of Post- to Pre-treatment BAL ELF Total Neutrophil Elastase Level|Median ratio of post- to pre-treatment BAL ELF Total Neutrophil Elastase Level|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol|||nM||Full Range|Median
1265291|NCT00396006|Other Pre-specified|Change in the BAL ELF Free Neutrophil Elastase Level|Median change in the BAL ELF Free Neutrophil Elastase Level from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol population with both pre- and post-treatment analytes available from BAL procedures|||nM||Full Range|Median
1265292|NCT00396006|Secondary|Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level|Mean change in the plasma ANEC level from baseline to post-treatment|Blood samples were collected at baseline and after 8 consecutive weeks of treatment|Per protocol|||μM||Standard Deviation|Mean
1265293|NCT00396006|Secondary|Change in the α1-PI Plasma Level|Mean change in the plasma level of α1-PI from baseline to post-treatment|Blood samples were collected at baseline and after 8 consecutive weeks of treatment|Per protocol|||μM||Standard Deviation|Mean
1265294|NCT00396006|Secondary|Change in in the Ratio of BAL ELF α1-PI to Human Neutrophil Elastase (HNE) Complex Concentration|Median change in the ratio of BAL ELF α1-PI to HNE complex concentration from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|No per protocol subject had both pre- and post-treatment analytes available, therefore no analysis could be performed on this outcome measure||||||
1265295|NCT00396006|Secondary|Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels|Median ratio of post- to pre-treatment BAL ELF ANEC levels|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol|||μM||Full Range|Median
1265296|NCT00396006|Primary|The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min||During 8 consecutive weeks of treatment|Intent to treat|||adverse events|||Number
1265297|NCT00396006|Primary|Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level|Median change BAL ELF antigenic α1-PI level the from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol|||μM||Full Range|Median
1265298|NCT00395993|Primary|Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL||Any time between baseline and the end of study or time to intervention|Modified Intent-to-Treat Population defined as subjects from the Safety Population who received at least 1 dose of study medication, had average baseline hemoglobin, TSAT, and ferritin levels, had heavy uterine bleeding, and had at least 1 post-baseline hemoglobin assessment.|||participants|||Number
1265299|NCT00395967|Secondary|Graft Durability at 12 Months After Transplantation|"Participants with durable grafts. Graft durability was assessed by complete blood count (CBC) and differential analysis at 12 months post-transplantation.~This study was terminated early and analysis was not done."|13 months|This study was terminated early and analysis was not done.||||||
1265300|NCT00395967|Secondary|Number of Days to Platelet (PLT) Engraftment|"The median number of days to platelet (PLT) engraftment criteria was ≥ 20*10^9/L platelets without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that criteria were met.~This study was terminated early and analysis was not done."|2 months|This study was terminated early and analysis was not done.||||||
1265301|NCT00395967|Secondary|Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|"The median number of days to PMN engraftment criteria was PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that criteria were met.~This study was terminated early and analysis was not done."|2 months|This study was terminated early and analysis was not done.||||||
1265302|NCT00395967|Secondary|The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor|"The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and expressed as a ratio. Fold increase = pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).~This study was terminated early and analysis was not done."|Days 5-6|This study was terminated early and analysis was not done.||||||
1265303|NCT00395967|Secondary|Overall Participants Counts of Adverse Events|Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.|up to 13 months|Safety Population defined as all participants who received G-CSF and/or plerixafor.|||participants|||Number
1265304|NCT00395967|Primary|Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days|The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.|approximately days 6-9|All patients who received plerixafor.|||participants|||Number
1265305|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 7 days post-treatment|Number of patients (from MITT population) with restored CVC function during the treatment period|||Percentage of patients||95% Confidence Interval|Number
1265306|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 120 minutes post-treatment|Modified intent to treat (MITT) population|||percentage of participants||95% Confidence Interval|Number
1265307|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after third dose|Modified intent to treat (MITT) population|||Percentage of patients||95% Confidence Interval|Number
1265308|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after third dose|Modified intent to treat (MITT) population|||Percentage of patients||95% Confidence Interval|Number
1265413|NCT00395486|Secondary|Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)|Calculate the percentage reduction of LDL-C|Baseline and 6 weeks||||percentage reduction||Standard Deviation|Mean
1265309|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after third dose|Modified intent to treat (MITT) population|||percentage of participants||95% Confidence Interval|Number
1265310|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after second dose|Modified intent to treat (MITT) population|||Percentage of patients||95% Confidence Interval|Number
1265311|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after second dose|Modified intent to treat (MITT) population|||Percentage of patients||95% Confidence Interval|Number
1265312|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after second dose|Modified intent to treat (MITT) population|||percentage of participants||95% Confidence Interval|Number
1265313|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after first dose|Modified intent to treat (MITT) population|||Percentage of patients|||Number
1265314|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265315|NCT00395876|Primary|Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
1265316|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 3|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[percent]|Participants|Standard Deviation|Mean
1265317|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 2|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[percent]|Participants|Standard Deviation|Mean
1265318|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 1|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[percent]|Participants|Standard Deviation|Mean
1265319|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
1265320|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
1265321|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
1265322|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
1265414|NCT00395486|Secondary|Percentage Change of Insulin Resistance Using QUICKI|QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)].|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
1265323|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
1265324|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
1265325|NCT00395863|Secondary|Lesion Contrast Enhancement Between the Two Exams|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.|||Contrast-enhanced Images|Participants||Number
1265326|NCT00395863|Secondary|Lesion Border Delineation|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.|||Contrast-enhanced Images|Participants||Number
1265327|NCT00395863|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.|||Contrast-enhanced Images|Participants||Number
1265328|NCT00395850|Secondary|Retention||14 weeks|those who were entered the disulfiram phase,e tc.|||Weeks||Standard Deviation|Mean
1265329|NCT00395850|Primary|Cocaine Use Over Time|Urine toxicology results (dichotomous: positive or negative) for the presence of cocaine/cocaine metabolite during the disulfiram phase of the study. The change in the probability of a cocaine positive urine sample per day was assessed for each dose compared with placebo and slopes for each dose condition were calculated from Repeated Measures Genearlized Linear Models on a Binomial distribution (thus a Repeated Measures Logistic Regression)|thrice weekly for 12 weeks|number is based on those who participated long enough to have assessments completed at two time points during the disulfiram phase|||slope (change in prob of coc-pos utox/d)|||Number
1265330|NCT00395746|Secondary|Hypoglycaemic Episodes|Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|over 52 weeks of treatment|Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.|||number of events per year of exposure|||Number
1265331|NCT00395746|Secondary|Body Weight After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||kg||Standard Error|Least Squares Mean
1265332|NCT00395746|Secondary|Body Weight After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||kg||Standard Error|Least Squares Mean
1265333|NCT00395746|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265334|NCT00395746|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265335|NCT00395746|Secondary|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265336|NCT00395746|Secondary|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265337|NCT00395746|Secondary|Postprandial Glucose AUC After 52 Weeks of Treatment|Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL *h||Standard Error|Least Squares Mean
1265338|NCT00395746|Secondary|Postprandial Glucose AUC After 24 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL *h||Standard Error|Least Squares Mean
1265339|NCT00395746|Secondary|Fasting Plasma Glucose After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265340|NCT00395746|Secondary|Fasting Plasma Glucose After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265341|NCT00395746|Secondary|Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
1265342|NCT00395746|Primary|Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
1265343|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 3|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Vessels|||Number
1265344|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 2|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Vessels|||Number
1265345|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 1|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Vessels|||Number
1265346|NCT00395733|Secondary|MRA Diagnosis by Investigators|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.|||Vessels|||Number
1265347|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3|Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Participants|||Number
1265348|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2|Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Participants|||Number
1265349|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1|Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Participants|||Number
1265350|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator|The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.|||Participants|||Number
1265351|NCT00395733|Primary|Number of Vessel Segments Visualized With Diagnostic Quality|Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||vessel segments||Standard Deviation|Mean
1265352|NCT00395694|Secondary|Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8|Monocytes are a type of white blood cell (WBC; typically comprising 2%-8% of total WBCs) and are a part of the immune system. The normal range for adults is 0.2 to 0.95 * 10^3 cells per microliter (µL); the normal range for adolescents is 0 to 0.8 * 10^3 cells per µL. The monocyte count may increase during chronic inflammation, stress response, immune-mediated disease, viral fever, etc. The percentage of participants (par.) with monocyte values outside the normal range was calculated as 100 * (number of par. with monocyte values outside the normal range) divided by the total number of par.|Week 4 and Week 8|Safety Population|||percentage of participants|||Number
1265353|NCT00395694|Secondary|Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA|The rash adjudication committee reviewed all rash events from a dermatologic standpoint based on the nature, onset site, affected area, time to onset, outcome, and the investigator's comments to adjudicate whether or not the reported event was a drug eruption. A drug eruption is an eruption or a solitary lesion caused by a drug taken internally, often a result of allergic sensitization.|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.|||adjudicated rash events|total rash events||Number
1265354|NCT00395694|Secondary|Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.|||rash events|||Number
1265355|NCT00395694|Secondary|Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.|||participants|||Number
1265356|NCT00395694|Secondary|Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.|||rash events|||Number
1265357|NCT00395694|Secondary|Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population|||participants|||Number
1265358|NCT00395694|Secondary|Percent Change in Seizure Frequency of the Indicated Types of Seizures|Percent change in seizure frequency was calculated as 100 * (pre-treatment seizures minus MP seizures)/pre-treatment seizures. Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types, mental retardation or regression, and abnormal findings on an ECG.|Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)|FAS Population|||percent change||95% Confidence Interval|Median
1265359|NCT00395694|Secondary|Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures|Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types; mental retardation or regression; and abnormal findings on an electroencephalogram (EEG), with paroxysms of fast activity and generalized slow spike-and-wave discharges.|8 weeks|Full Analysis Set (FAS) Population: all enrolled participants except those who had no assessments of the main efficacy variable (percent reduction in seizure frequency).|||percentage of participants|||Number
1265360|NCT00395694|Secondary|Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?."|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.|||rash events|||Number
1265361|NCT00395694|Secondary|Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.|||participants|||Number
1265362|NCT00395694|Secondary|Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.|||rash events|||Number
1265363|NCT00395694|Primary|Number of Participants With Any Rash Event (Including Stevens–Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|8 weeks|Safety Population: all participants enrolled in the study who received at least one dose of study medication|||participants|||Number
1265364|NCT00395642|Primary|Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.|Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion.|6 months|All Enrolled Participants|||Percent of days|||Number
1265365|NCT00395629|Secondary|Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)|A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated.|4, 8, 12, 16, 20, and 24 weeks|Per-protocol population included all participants of the safety population; who received at least one dose of study drug within the core study and had at least one safety assessment, and who did not have any major protocol deviation. n in each of the Categories is the number of participants in each arm/group who had data for that time point.|||µmol/L||Standard Deviation|Mean
1265366|NCT00395629|Primary|Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)|Mean absolute change in serum ferritin from baseline to the end of the extension study.|0 to 48 weeks|Extension Per-protocol population including all participants of the per protocol population who also were part of the extension safety population.|||µg/L||Standard Deviation|Mean
1265367|NCT00395512|Secondary|Change From Baseline in Mean HDL Particle Size|Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
1265368|NCT00395512|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||µmol/L||Standard Error|Least Squares Mean
1265369|NCT00395512|Secondary|Change From Baseline in Mean LDL Particle Size|Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
1265370|NCT00395512|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1265371|NCT00395512|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles|"The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1265372|NCT00395512|Secondary|Change From Baseline in Mean VLDL Particle Size|Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
1265373|NCT00395512|Secondary|Change From Baseline in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1265374|NCT00395512|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265375|NCT00395512|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1265376|NCT00395512|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides|Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265377|NCT00395512|Secondary|Change From Baseline in Apolipoprotein C-III|Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265378|NCT00395512|Secondary|Change From Baseline in Apolipoprotein B|Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265379|NCT00395512|Secondary|Change From Baseline in Apolipoprotein A2|Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265380|NCT00395512|Secondary|Change From Baseline in Apolipoprotein A1|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265381|NCT00395512|Secondary|Change From Baseline in Adiponectin|Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
1265382|NCT00395512|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein|Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
1265383|NCT00395512|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1|Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1265384|NCT00395512|Secondary|Change From Baseline in Free Fatty Acids|Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
1265385|NCT00395512|Secondary|Change From Baseline in Triglyceride Levels|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265386|NCT00395512|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265387|NCT00395512|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265388|NCT00395512|Secondary|Change From Baseline in Total Cholesterol Level|Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265389|NCT00395512|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate.|Baseline and Weeks 8, 12, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||kg||Standard Error|Least Squares Mean
1265390|NCT00395512|Secondary|Change From Baseline in Homeostatic Model Assessment Beta Cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5~The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
1265391|NCT00395512|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5~A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
1265392|NCT00395512|Secondary|Change From Baseline in C-peptide Levels|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1265393|NCT00395512|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1265394|NCT00395512|Secondary|Change From Baseline in Insulin|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μIU/mL||Standard Error|Least Squares Mean
1295931|NCT00075478|Secondary|Incidence of Non-relapse Mortality|Percentage of NRM as estimated by cumulative incidence methods with competing risks|3 years after transplant||||percentage of participants|||Number
1265395|NCT00395512|Secondary|Change From Baseline in Fasting Proinsulin|Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1265396|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 2.0%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1265397|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1.5%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1265398|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1265399|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 0.5%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1265400|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7.5%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1265401|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1265402|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤6.5%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1265403|NCT00395512|Secondary|Percentage of Participants Meeting Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory:~After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose ≥310 mg/dL (≥17.5 mmol/L);~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥275 mg/dL (≥15.27 mmol/L);~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with the Baseline HbA1c."|Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set including patients with visits during or after the specified interval in each treatment group.|||percentage of participants|||Number
1265404|NCT00395512|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories.|Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set including patients with at least one non-missing fasting plasma glucose result in the specified interval in each treatment group.|||percentage of participants|||Number
1265405|NCT00395512|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1265406|NCT00395512|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|Baseline and Weeks 4, 8, 12, 16 and 20.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1265407|NCT00395512|Primary|Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26|The Full analysis Set (all randomized patients who took at least 1 dose of double-blind study drug) where a Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1265408|NCT00395486|Secondary|Percentage Change of Apolipoprotein B (ApoB)|Calculate the percentage change of apolipoprotein B|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
1265409|NCT00395486|Secondary|Percentage Change of Apolipoprotein A1 (ApoA1)|Calculate the percentage change of Apolipoprotein A1|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
1265410|NCT00395486|Secondary|Percentage Change of Triglycerides (TG)|Calculate the percentage change of Triglycerides.|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
1265418|NCT00395486|Secondary|Percentage of Subjects Reaching Their LDL-C Target Goal|Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk).|Baseline and 6 weeks||||percentage of participants|||Number
1265419|NCT00395486|Primary|Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6|Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.|Baseline and 6 weeks||||percent change||Standard Deviation|Mean
1265420|NCT00395460|Other Pre-specified|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases|Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with CNS lesions other than primary malignant brain tumor(s) / brain metastases|||Lesions||Standard Deviation|Mean
1265421|NCT00395460|Other Pre-specified|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases|Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with primary malignant brain tumor(s) / brain metastases|||Lesions||Standard Deviation|Mean
1265422|NCT00395460|Other Pre-specified|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases|CNR = (SI lesion – SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with CNS lesions other than primary malignant brain tumor(s) / brain metastases. 1 (Gadavist) and 2 participants (Magnevist) had missing values for signal intensity for CNS lesions pre- and post-contrast and could not be considered for evaluation.|||Contrast to Noise ratio||Standard Deviation|Mean
1265423|NCT00395460|Other Pre-specified|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases|CNR = (SI lesion – SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with primary malignant brain tumor(s) / brain metastases. One participant in the Gadavist group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.|||Contrast to Noise ratio||Standard Deviation|Mean
1265424|NCT00395460|Secondary|Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions|Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'.|||Lesion delineation score||Standard Deviation|Mean
1265425|NCT00395460|Secondary|Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI|The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'.|||Contrast enhancement score||Standard Deviation|Mean
1265426|NCT00395460|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment|The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as “improved”, “unchanged” or “worsened” for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases.|||Participants|||Number
1265427|NCT00395460|Secondary|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan|The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases|||Lesions||Standard Deviation|Mean
1265428|NCT00395460|Primary|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions|CNR = (signal intensity [SI] lesion – SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Two participants in each treatment group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.|||Contrast to Noise ratio||Standard Deviation|Mean
1265429|NCT00395447|Primary|Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification)|The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).|6 months||||Percentage of participants (%)||95% Confidence Interval|Mean
1265430|NCT00395343|Other Pre-specified|Change From Baseline in A1C at Week 24|"A1C in subset of patients on long-acting or intermediate-acting insulin.~A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent."|Baseline and Week 24|The Full Analysis Set (FAS) included the subset of patients on long-acting or intermediate-acting insulin with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
1265431|NCT00395343|Secondary|Percent of Patients With A1C < 6.5% at Week 24||Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent|||Number
1265432|NCT00395343|Secondary|Percent of Patients With A1C < 7.0% at Week 24||24 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent|||Number
1265433|NCT00395343|Secondary|Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24|Static sensitivity is a measure of the effect of glucose on beta-cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.)|Baseline and Week 24|The Full Analysis Set (FAS) included all patients who participated in the 10-point meal tolerance test and had a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
1265434|NCT00395343|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1265435|NCT00395343|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1265436|NCT00395343|Primary|Change From Baseline in A1C at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
1265437|NCT00395304|Secondary|Number of Participants With Asthma Exacerbations|An asthma exacerbation was defined as the administration of a course of oral/systemic prednisone for the treatment of asthma.|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||Participants|||Count of Participants
1265438|NCT00395304|Secondary|Change From Baseline in Asthma Quality of Life|Asthma quality of life is measured as the average of 23 questions, each of which is scored from 1 (worse) to 7 (best)|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||units on a scale||Standard Deviation|Mean
1265439|NCT00395304|Secondary|Change From Baseline in the Asthma Control Test (ACT)|The ACT consists of five items, each scored as 1 (worst) to 5 (best). The five items are averaged.|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||units on a scale||Standard Deviation|Mean
1265440|NCT00395304|Secondary|Change From Baseline in the Natural Logarithm of Exhaled Nitric Oxide (eNO)||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||natural logarithm of parts per billion||Standard Deviation|Mean
1265441|NCT00395304|Secondary|Change From Baseline in the Logarithm Base 2 of the Methacholine PC20|The methacholine PC20 is the concentration of methacholine that causes a 20% decrease in the pre-bronchodilator FEV1. The logarithm base 2 transformation converts the PC20 into doubling dilutions.|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||doubling dilutions||Standard Deviation|Mean
1265442|NCT00395304|Secondary|Change From Baseline in the Impulse Oscillometry Resistance at 5 Hertz|Change from baseline in the impulse oscillometry resistance at 5 Hertz, measured in kiloPascals per liters per second|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||kiloPascals per liters per second||Standard Deviation|Mean
1265443|NCT00395304|Secondary|Change From Baseline in the Peak Expiratory Flow Rate (PEFR) Variability|PEFR variability is calculated as 100% times the difference between the evening and morning PEFR values, divided by the average of the evening and morning PEFR values, i.e., PEFR variability = 100% x (morning PEFR - evening PEFR)/((morning PEFR + evening PEFR)/2)|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
1265444|NCT00395304|Secondary|Change From Baseline in the Evening Peak Expiratory Flow Rate (PEFR) % Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
1265445|NCT00395304|Secondary|Change From Baseline in the Morning Peak Expiratory Flow Rate (PEFR) % Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
1265446|NCT00395304|Secondary|Change From Baseline in the Pre-bronchodilator FEV1/FVC Ratio||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||ratio||Standard Deviation|Mean
1265447|NCT00395304|Secondary|Change From Baseline in the Pre-bronchodilator Forced Vital Capacity (FVC) % Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
1265448|NCT00395304|Secondary|Change From Baseline in the Post-bronchodilator FEV1 Percent Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
1265449|NCT00395304|Secondary|Change From Baseline in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) % Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
1265450|NCT00395304|Primary|The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.|One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1.|Measured during the last 12 weeks of each 16-week treatment period|ITT. Although only 157 participants completed all three treatment periods, there was sufficient data on 8 additional participants to include them in the analysis of the primary outcome.|||Participants|||Number
1265451|NCT00395291|Secondary|Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions and lab results were available for all 22.|||pg/ml||Standard Deviation|Mean
1265452|NCT00395291|Secondary|Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Adiponectin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||ng/ml||Standard Deviation|Mean
1265453|NCT00395291|Secondary|Change in Esterase After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Esterase levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions and results were available.|||units/ml||Standard Deviation|Mean
1265454|NCT00395291|Secondary|Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IL-10 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||pg/ml||Standard Deviation|Mean
1265455|NCT00395291|Secondary|Changes in the Following Level: IL-6|Change in IL-6 after 30 days of intervention.|After the subject has comleted their last visit|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||pg/mL||Standard Deviation|Mean
1265456|NCT00395291|Secondary|Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IL-1 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||pg/ml||Standard Deviation|Mean
1265458|NCT00395291|Secondary|Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the TNF-alpha levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||pg/ml||Standard Deviation|Mean
1265459|NCT00395291|Secondary|Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Des-Acyl Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions.|||pg/ml||Standard Deviation|Mean
1265460|NCT00395291|Secondary|Change in Insulin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Insulin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions.|||uIU/ml||Standard Deviation|Mean
1265461|NCT00395291|Secondary|Change in Leptin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Leptin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions.|||ng/ml||Standard Deviation|Mean
1265462|NCT00395291|Secondary|Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Acyl-Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention.|22 subjects completed both interventions.|||pg/ml||Standard Deviation|Mean
1265463|NCT00395291|Primary|Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IGF-1 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions and lab results were available.|||ng/ml||Standard Deviation|Mean
1265464|NCT00395226|Primary|Severity of Facial Rosacea After 90 Days of Treatment|Modified Rosacea Severity Scoring System evaluating four signs of rosacea, flushing (transient erythema or redness), erythema (redness), papules and pustules and telangiectasia (spider-veins) ranges from 0 (best, absent) to 12 (worst, severe on all items)|90 days||||units on scale 0 to 12||95% Confidence Interval|Mean
1265465|NCT00395161|Secondary|All-cause 28-day Mortality Rate.||28 days after admission to the PICU|This safety outcome was analyzed by treatment received, among a total of 284 children who received treatment and had known 28-day status.|||participants|||Number
1265466|NCT00395161|Secondary|Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)|What is reported is the number of participants with counts qualifying as lymphopenia.|from time of PICU admission till discharge from PICU|All randomized patients (intention to treat analysis)|||participants|||Number
1265467|NCT00395161|Secondary|Antibiotic-free Days||48 hours after admission until PICU discharge|All randomized patients per intention to treat analysis|||Days||Inter-Quartile Range|Median
1265468|NCT00395161|Secondary|Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days||48 hours after PICU admission till discharge from PICU|All randomized patients analyzed by intention to treat|||Mean number of events per 100 study days||95% Confidence Interval|Mean
1265469|NCT00395161|Primary|The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.||48 hours after admission until 5 days after discharged from the PICU|Intention to treat analysis of all randomized patients.|||Days||95% Confidence Interval|Median
1265470|NCT00395135|Secondary|Year 2: Percent Change in Body Weight From Week 52 to Week 104|Year 2: The % change in body weight (kg) from week 52 to week 104.|52 weeks|MITT with LOCF|||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
1265471|NCT00395135|Secondary|Year 1: Percent Change in Body Weight From Baseline to Week 52|Year 1: The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF|||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
1265472|NCT00395135|Primary|Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104|The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.|104 weeks|MITT with LOCF|||percentage of participants|||Number
1265473|NCT00395135|Primary|Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1.~Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF|||percentage of participants|||Number
1265474|NCT00395083|Secondary|Time to All-Cause Death||From randomization until death, assessed up to 26 months||||years||95% Confidence Interval|Median
1265475|NCT00395083|Secondary|Hazard Ratio for All-Cause Mortality||26 months||||participants|||Number
1265476|NCT00395083|Primary|Hazard Ratio for First COPD Hospitalization||26 months||||participants|||Number
1265477|NCT00395083|Primary|Hospitalization-free Survival - Time to Event||From randomization until date of first hospitalization for COPD, assessed up to 26 months||||years||95% Confidence Interval|Median
1265478|NCT00395057|Secondary|Time to Treatment With Standard of Care at Month 6|Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.|Month 6|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).|||Number of Days||95% Confidence Interval|Median
1265479|NCT00395057|Secondary|Visual Functioning Questionnaire (VFQ) at Month 3|Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). Data for this outcome measure were not analyzed as the study was terminated early.||||||
1265547|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Mental Health|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265480|NCT00395057|Secondary|Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3|Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).|||Microns||Standard Deviation|Mean
1265481|NCT00395057|Secondary|Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3|Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc.|Month 3|Intent-To-Treat. The ITT population included all patients who started the study (randomized).|||Millimeters squared (mm^2)||Standard Deviation|Mean
1265482|NCT00395057|Primary|Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3|Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).|||Percentage of Patients|||Number
1265483|NCT00395044|Secondary|Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4|The D-KEFS is a testing battery designed to measure executive functioning, a critical component of participating in cognitive behavioral therapy used to treat marijuana dependence. Data were obtained from the D-KEFS test instruments completed at baseline and week 4, which included the Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. Scaled scores range from 1 (worst) to 19 (best). Change = (Week 4 score - Week 0 score). Positive values indicate increased executive functioning.|Week 0 and Week 4|Cognitive testing was done in a subset of participants enrolled in the study, beginning with randomized subject #21 and continuing until the 50th subject was randomized. The number analyzed is the total number available for analysis that completed both the Baseline and Week 4 assessment.|||scores on a scale||Standard Deviation|Mean
1265484|NCT00395044|Secondary|Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12|The MPS is an instrument to assess the incidence of physical, psychological, social, and functioning problems that can result from cannabis dependence. The Total score ranges from 0-38 where 0=best outcome and 38=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
1265485|NCT00395044|Secondary|Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12|The Marijuana Craving question of the Marijuana Withdrawal Checklist assesses severity of craving to smoke marijuana. The craving question is rated on a scale of 0-3 where 0=best outcome (no symptoms) and 3=worst outcome (severe symptoms). Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
1265486|NCT00395044|Secondary|Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12|The BDI-II is a self-rating of severity of depressive symptoms. The Total score range on the BDI-II is from 0-63; 0=best outcome; 63=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
1265487|NCT00395044|Secondary|Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12|The PSQI is an instrument to assess subjective sleep quality and disturbance. The range on the measure is from 0-21: 0=best outcome; 21=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
1265488|NCT00395044|Secondary|Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12|The MWC is an instrument to assess the severity of frequently reported cannabis withdrawal symptoms. Each question on the measure is recorded as a severity rating between 0-3: 0=best outcome; 3=worst outcome. The severity rating of each question was averaged to obtain a single marijuana withdrawal severity score. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
1265489|NCT00395044|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography-mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use.|Week 0 and Week 12||||ng/ml||Standard Deviation|Mean
1265490|NCT00395018|Primary|Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72|HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.|At baseline (day 1), week 12, 24, 36, 48, 60, and 72|Evaluable population: Treated participants who received at least 1 month of ETV therapy. Non-Completer = Missing (NC = M) approach was used where participants who discontinued early or were missing the measurement were excluded from the specific analysis.|||participants||95% Confidence Interval|Number
1265491|NCT00395018|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)|Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:>1.25xULN;AST:>1.25xULN;ALP:>1.25xULN;Total Bilirubin:>1.1xULN;Serum Lipase:>1.10xULN;Creatinine:>1.1xULN;Blood Urea Nitrogen:>1.25xULN;Hyperglycemia:>116mg/dL;Hypoglycemia:<64mg/dL;Hyponatremia:<132meq/L;Hypernatremia:>148meq/L;Hypokalemia:<3.4meq/L;hyperkalemia:>5.6meq/L;Hypochloremia:<93meq/L;Hyperchloremia:>113meq/L;Albumin: Decrease >= 1g/dL from baseline and < 3 g/dL. HYPER=value>ULN(upper limit of normal). HYPO=value<LLN (lower limit of normal).|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: Participants who received atleast 1 dose of study drug.|||participants|||Number
1265492|NCT00395018|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)|Criteria for hematology abnormalities were: Hemoglobin : <11.0 g/dL; White Blood Cells : <4000/mm^3; Neutrophils : <1500/mm^3; Platelets : < 99,000/mm^3; International Normalized Ratio (INR) : increase >= 0.5 from baseline.|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: All subjects who received atleast 1 dose of study drug.|||participants|||Number
1265493|NCT00395018|Secondary|Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up.|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: Participants who received atleast 1 dose of study drug.|||participants|||Number
1265494|NCT00395018|Secondary|Number of Participants With Re-transplantation Through Week 72||Through week 72|Treated population: Participants who received atleast 1 dose of study drug.|||participants|||Number
1265495|NCT00395018|Secondary|Number of Participants With Liver Rejection Through Week 72||Through week 72|Treated participants: Participants who received atleast 1 dose of study drug.|||participants|||Number
1265496|NCT00395018|Secondary|Prothrombin Time (PT) at Week 72|Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: > 1.01 x ULN.|At week 72|Treated participants with measures available at week 72.|||seconds||Standard Error|Mean
1265497|NCT00395018|Secondary|Total Bilirubin at Week 72|Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : => 1.1 x ULN mg/dL.|At week 72|Treated participants with measures available at week 72.|||mg/dL||Standard Error|Mean
1265498|NCT00395018|Secondary|Percentage of Participants With HBsAg Recurrence At Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
1265499|NCT00395018|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
1265500|NCT00395018|Secondary|Percentage of Participants With HBsAg Loss at Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
1265501|NCT00395018|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)|HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|At week 72|HBeAg-positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
1265502|NCT00395018|Secondary|Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week.|At week 72|HBeAg positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
1265503|NCT00395018|Secondary|Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up|HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL.|At 72 weeks + 24 weeks follow-up|This analysis was planned if > 10% of treated participants had HBV DNA measurements during the off-treatment follow-up period.|||percentage of participants|||Number
1265504|NCT00395018|Secondary|Distribution of ALT Levels Through 72 Weeks: Overall|ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = >1.25 x ULN (upper limit of normal).|On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72|Evaluable population: Treated participants who received at least 1 month of ETV therapy.|||U/L||Standard Error|Mean
1265505|NCT00395018|Primary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72|HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.|At 72 weeks|Evaluable population: Treated participants who received at least 1 month of ETV therapy. Last observation carried forward (LOCF) approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
1265548|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Vitality|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265506|NCT00394953|Secondary|Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.|From screening to Week 56|The Safety Population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Among the 14 deaths in Darbepoetin alfa group, 3 participants died after withdrawal from the study and within 30 days after last dose of study drug.|||Participants|||Number
1265507|NCT00394953|Secondary|Mean Pulse Rate Over Time|Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.|Baseline (Week -4 to Week -1), Week 28, and Week 52|The Safety population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.|||beats per minute||Standard Deviation|Mean
1265508|NCT00394953|Secondary|Median Blood Pressure Over Time|Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.|Baseline (Week -4 to Week -1), Week 28, and Week 52|Safety Population included all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.|||millimeter of mercury||Full Range|Median
1265509|NCT00394953|Secondary|Number of Participants With Marked Laboratory Abnormality Over Time|Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.|||participants|||Number
1265510|NCT00394953|Secondary|Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time|All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.|Week 27 to Month 12|ITT population included all randomized participants. Data is presented for the participants available at the time of assessment.|||percent change||Standard Deviation|Mean
1265511|NCT00394953|Primary|Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period|Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.|Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)|ITT population included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1265512|NCT00394914|Secondary|LS Mean Change From Baseline in Asthma-Related Sleep Interference|Participants entered their asthma-related changes in sleep into an e-diary once daily (in the morning) beginning at the Screening Visit through completion of the study. Changes from Baseline in asthma-related sleep interference were determined using the following question: How did cold and asthma symptoms interfere with your sleep? The question was scored as follows: 0 = None, no interference with sleep at all, 1 = Mild, not annoying or troublesome, adequate amount of sleep, 2 = Moderate, interfered somewhat with sleep, woke up a few times, average sleep, 3 = Severe, substantially interfered with sleep, poor sleep. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some sleep follow-up information.|||units on a scale||Standard Deviation|Least Squares Mean
1265513|NCT00394914|Secondary|LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage|SABAs such as albuterol were permitted during the study as rescue medication and required a 6-hour washout prior to each visit. Participants entered their asthma medication use into an e-diary twice daily beginning at the Screening Visit through completion of the study. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some SABA follow-up information.|||number of puffs of SABA||Standard Deviation|Least Squares Mean
1265522|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 13|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 13|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265514|NCT00394914|Secondary|LS Mean Change From Baseline in Total Asthma Symptom Score|Participants entered their asthma symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total asthma symptom score was the sum of 3 scores for wheeze, cough, and dyspnea. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 9, with increasing scores reflecting more severe asthma. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some asthma symptom score follow-up information.|||units on a scale||Standard Deviation|Least Squares Mean
1265515|NCT00394914|Secondary|LS Mean Change From Baseline in Total Cold Symptom Score|Participants entered their cold symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total cold symptom score was the sum of 6 scores for rhinorrhea, nasal congestion, cough, score throat, malaise, and myalgia. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 18, with increasing scores reflecting more severe colds. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some cold symptom score follow-up information.|||units on a scale||Standard Deviation|Least Squares Mean
1265516|NCT00394914|Secondary|LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM|PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.|||L/min||Standard Deviation|Least Squares Mean
1265517|NCT00394914|Secondary|LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM|PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.|||L/min||Standard Deviation|Least Squares Mean
1265518|NCT00394914|Secondary|LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some FEV1 follow-up information.|||liters||Standard Deviation|Least Squares Mean
1265519|NCT00394914|Secondary|LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)|The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some ACQ follow-up information.|||units on a scale||Standard Deviation|Least Squares Mean
1265520|NCT00394914|Primary|Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR|"Asthma exacerbation was defined as a participant having one of the following:~0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ.~Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization.~PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization."|From time of exposure to index case to end of Follow-up Period (21 days)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine exacerbation.|||percentage of participants|||Number
1265521|NCT00394914|Primary|Percentage of Participants With Rhinovirus PCR-Positive Colds|The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.|From time of exposure to index case to end of Follow-up Period (21 days)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine rhinovirus cold.|||percentage of participants|||Number
1265543|NCT00394901|Primary|Mean Pain Scores at Week 5|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 5|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265523|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 12|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 12|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265524|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 11|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 11|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265525|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 10|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 10|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265526|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 9|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 9|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265527|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 8|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 8|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265528|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 7|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 7|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265529|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 6|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 6|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265530|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 5|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 5|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265531|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 4|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 4|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265532|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 3|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 3|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265533|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 2|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 2|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265534|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 1|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 1|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265535|NCT00394901|Primary|Mean Pain Scores at Week 13|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 13|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265536|NCT00394901|Primary|Mean Pain Scores at Week 12|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 12|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265537|NCT00394901|Primary|Mean Pain Scores at Week 11|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 11|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265538|NCT00394901|Primary|Mean Pain Scores at Week 10|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 10|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265539|NCT00394901|Primary|Mean Pain Scores at Week 9|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 9|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265540|NCT00394901|Primary|Mean Pain Scores at Week 8|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 8|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265541|NCT00394901|Primary|Mean Pain Scores at Week 7|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 7|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265542|NCT00394901|Primary|Mean Pain Scores at Week 6|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 6|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265549|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265550|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265551|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265552|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265553|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265554|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265555|NCT00394901|Secondary|Endpoint Clinical Global Impression Change|Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Deviation|Mean
1265556|NCT00394901|Secondary|Endpoint Patient Global Impression Change|Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Deviation|Mean
1265557|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep|Number of participants who reported Optimal Sleep|Week13/discontinuation|Full analysis set. Last observation carried forward.|||participants|||Number
1265558|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index|Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265559|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence|Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265560|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy|Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265561|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep|Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265562|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache|Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265563|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring|Score range for snoring is 0-100.Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265564|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance|Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265565|NCT00394901|Secondary|Mean Sleep Interference Scores at Endpoint|Scores range from 0-10. Higher scores indicate more severe interference with sleep.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265566|NCT00394901|Secondary|Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire|Present pain intensity score range from 0-5. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265567|NCT00394901|Secondary|Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire|Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||mm||Standard Error|Least Squares Mean
1265568|NCT00394901|Secondary|Endpoint Total Scores of the Short-Form McGill Pain Questionnaire|Total score range from 0-45. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward|||score on scale||Standard Error|Least Squares Mean
1265569|NCT00394901|Secondary|Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire|Affective score range from 0-12. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265570|NCT00394901|Secondary|Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire|Sensory score range from 0-33. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265571|NCT00394901|Primary|Mean Pain Scores at Week 3|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 3|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265572|NCT00394901|Primary|Mean Pain Scores at Week 2|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 2|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265573|NCT00394901|Primary|Mean Pain Scores at Week 1|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 1|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
1265574|NCT00394901|Primary|Number of Responders|A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||participants|||Number
1265575|NCT00394901|Primary|Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations|Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265576|NCT00394901|Primary|Mean Pain Scores at Endpoint|Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
1265577|NCT00394888|Primary|Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound|The number of participants with multiple (greater than or equal to 5) cutaneous infantile hemangiomas who were found to have hepatic hemangiomas via the us abdominal ultrasound.|2 years|Subjects enrolled in the hepatic hemangioma arm (n= 151) were analyzed for this outcome measure.|||Participants|||Number
1265578|NCT00394888|Primary|Cardiac Abnormalities Detected Via Clinical Examination|The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.|2 years|Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.|||Participants|||Number
1265579|NCT00394888|Primary|Cerebrovascular and Structural Brain Abnormalities|The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.|2 years|Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.|||Participants|||Number
1265580|NCT00394888|Primary|Spinal Abnormalities|The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.|2 years|Subjects enrolled in the lumbrosacral hemangioma arm (n= 48) were analyzed for this outcome measure|||Participants|||Number
1265581|NCT00394888|Primary|Clinical Diagnosis of PHACE Syndrome|For subjects in the large facial hemangioma arm of the study, a clinical assessment by trained physicians was conducted to determine whether or not each subject met diagnostic criteria for PHACE syndrome.|2 years|Subjects enrolled in the large facial hemangioma arm (n= 108) were analyzed for this outcome measure.|||Participants|||Number
1265582|NCT00394888|Primary|MRI/MRA of Head/Neck/Chest.||2 years||||participants|||Number
1265583|NCT00394836|Secondary|Vss After the Eighth Infusion (Visit 9, Week 7)|Vss is the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7; to up 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data of 28 April 2009.|||mL||Geometric Coefficient of Variation|Geometric Mean
1265584|NCT00394836|Secondary|CL After the Eighth Infusion (Visit 9, Week 7)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.|||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1265585|NCT00394836|Secondary|t1/2 After the Eighth Infusion (Visit 9, Week 7)|t1/2 is defined as terminal half-life, which is the time required for the amount of the drug in the body to decrease by half.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.|||hours||Geometric Coefficient of Variation|Geometric Mean
1265586|NCT00394836|Secondary|AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.|||Milligrams * hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
1265587|NCT00394836|Secondary|Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before the start of the next infusion]).|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants who had a value. Cmax was not reported for one participant due to missing data. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.|||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
1265614|NCT00394771|Primary|Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||days||Full Range|Median
1265633|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
1265588|NCT00394836|Secondary|Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.)|FcR poly. affect the affinity with which FcRs interact with immunoglobulin molecules and are prognostic factors that are indicative of altered responsiveness to treatment and/or survival. A blood sample was drawn at Visit 1 for analysis (done in batches of several samples) of FcR poly. (Fcgamma RIIIa Valine/Phenylalanine genotypes [TT=thymidine/thymidine, TG=thymidine/guanine, GG=guanine/guanine] and Fcgamma RIIa Arginine/Histidine genotypes [AA=adenine/adenine, AG=adenine/guanine, GG=guanine/guanine]). Responders must have met the criteria for CR, CRu, or PR at either Month 3 or Month 6. Fc receptor polymorphisms and C1qA-276 results are not included in this results summary.|From first treatment (Visit 2) until Visit 12 (Month 6)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||participants|||Number
1265589|NCT00394836|Secondary|Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2|Blood samples were drawn from participants at Visits 1 and 2 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 2 minus the value at Visit 1 divided by the value at Visit 1) * 100.|Visits 1 (Week -2) and 2 (Week 0)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||Units per milliliter (U/mL)||Full Range|Median
1265590|NCT00394836|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were withdrawn from participants at Visits 1, 12, 13, and 18 for analysis of HAHA. Analysis of HAHA was done in batches.|Visits 1 (Screening), 12 (Month 6), 13 (Month 9), and 18 (Month 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||participants|||Number
1265591|NCT00394836|Secondary|Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.|From first treatment (Visit 2) until Visit 18 (Month 24)|FAS|||participants|||Number
1265592|NCT00394836|Secondary|Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood|"B-cell lymphoma 2 (BCL2) is the second member of a range of proteins initially described in chromosomal translocations involving chromosomes 14 and 18 in follicular lymphomas. BCL2 mitochondrial ribonucleic acid (mRNA) was measured by polymerase chain reaction (PCR) from peripheral blood. Participants who had no post-screening data were categorized as Missing."|Screening (Visit 1) until Month 24 (Visit 18)|FAS. Only those participants who were BCL2 positive at Screening were analyzed.|||participants|||Number
1265593|NCT00394836|Secondary|Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12|CD19 and CD20 are proteins found on the cell surface of B cells, and they can be detected in peripheral blood by flow cytometry. Flow cytometry of peripheral blood was performed for immediate analysis of cells with cluster of differentiation 19 (CD19+) and CD20+. The analysis will be done until a value is reached that is in the normal range. Percent change from Baseline (Visit 2) = (value at Visits 11 and 12 minus the value at Visit 2 divided by the value at Visit 2) * 100.|Visits 2 (Baseline), 11 (Month 3), and 12 (Month 6)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||percent change in cells||95% Confidence Interval|Median
1265594|NCT00394836|Secondary|Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24|Tumor size was measured by computed tomography (CT) scan and was computed as the sum of product of diameters (SPD) for the indicator lesions. CT scans with contrast of the neck, thorax, abdomen, and pelvis were performed at Screening and during the follow-up period (Month 3, 6, 9, 12, 18, and 24). The change in tumor size from Screening (Visit 1) was presented per Radiologist 1 (R1) and Radiologist 2 (R2). Percent change from Screening (Visit 1, Week -2) = (value at Visits 11, 12, 13, 14, 16, and 18 minus the value at Visit 1 divided by the value at Visit 1) * 100.|Visits 1 (Week -2), 11 (Month 3), 12 (Month 6), 13 (Month 9), 14 (Month 12), 16 (Month 18), and 18 (Month 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||percent change in tumor size||Full Range|Median
1265595|NCT00394836|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death. For participants who are lost to follow-up, overall survival will be censored at the date of the last attended visit at which the endpoint was assessed.|First dose (Week 0) until 5 years|FAS. As of the time of data cut-off, data for Overall Survival was not estimable because too few deaths have occurred at the time of study completion.|||Months||95% Confidence Interval|Median
1265596|NCT00394836|Secondary|Time to Next Follicular Lymphoma (FL) Therapy|Time to next FL (anti-lymphoma) therapy is defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.|From start of treatment (Week 0) until Month 24|FAS|||Months||95% Confidence Interval|Median
1265597|NCT00394836|Secondary|Progression-Free Survival|Progression-free survival (PFS) is defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From start of treatment (Week 0) until Month 24|FAS|||Months||95% Confidence Interval|Median
1265598|NCT00394836|Secondary|Duration of Response|The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate duration of response.|From start of treatment (Week 0) until Month 24|FAS. Only those participants classified as responders were analyzed.|||months||95% Confidence Interval|Median
1295932|NCT00075478|Primary|Overall Survival|Percentage of patients surviving as estimated by Kaplan-Meier.|3 years after transplant||||percentage of participants|||Number
1265599|NCT00394836|Primary|Number of Participants Classified as Responders and Non-responders for Objective Response (OR)|Based on OR over a 6-month period from start of treatment, participants were classified as responders/non-responders as follows: participants with CR, CRu, or PR were classified as responders, whereas participants with Stable Disease (SD; achieving less than PR but not consistent with PD), Progressive Disease (PD; 50% increase from nadir in the products of the greatest perpendicular diameters of any previously identified node or appearance of any new node >1 cm), or Not Evaluable (NE) participants were classified as non-responders.|6-month period from the start of treatment. There was a median time of response at Month 5.5 (participants were followed for up to 24 months).|FAS|||participants|||Number
1265600|NCT00394836|Primary|Number of Participants With Objective Response (OR)|OR was assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin's lymphoma. Participants with Complete Response (CR; complete disappearance of all detectable disease), Complete Response unconfirmed (CRu; any residual lymph node/nodal mass >1.5 centimeters [cm] in its longest transverse diameter that regressed >75% compared to baseline), or Partial Response (PR; >=50% decrease in the sum of the product of diameters of indicator lesions) were defined as responders for OR.|Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment|||participants|||Number
1265601|NCT00394771|Other Pre-specified|Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||days||Full Range|Median
1265602|NCT00394771|Other Pre-specified|Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||days||Full Range|Median
1265603|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 177-183|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||participants|||Number
1265604|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 85-91|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||participants|||Number
1265605|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||participants|||Number
1265606|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||participants|||Number
1265607|NCT00394771|Secondary|Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)|Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.|Day 177-183|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||participants|||Number
1265608|NCT00394771|Secondary|Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)|Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.|Day 85-91|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||participants|||Number
1265609|NCT00394771|Primary|Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||days||Full Range|Median
1265610|NCT00394771|Secondary|Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)|"Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.~Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity.~See pre-specified analyses for Number of Moderate to Heavy Bleeding Days."|Day 1-84|ITT population. However data was not summarized due to limitations in the diary data.||||||
1265611|NCT00394771|Secondary|Time to First Bleeding Day|"Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection.~Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding."|Day 1-84|ITT population. However this data was not summarized due to limitations in the diary data.||||||
1265612|NCT00394771|Secondary|Days With Bleeding During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||days||Full Range|Median
1265613|NCT00394771|Secondary|Days With Bleeding During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||days||Full Range|Median
1295980|NCT00075088|Secondary|Rehospitalization and Mortality||4 years|we did not have the resources to achieve this secondary aim that required long-term follow up (a labor intensive job). The PI is now retired.||||||
1265615|NCT00394706|Secondary|Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months|The Health Utilities Index Mark 3 system was used to evaluate generic health related quality of life (HRQL). The interview-administered version of HUI3 requires completion of a maximum of 39 questions. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).|6 months post hospital discharge|ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.|||units on a scale||Standard Deviation|Mean
1265616|NCT00394706|Secondary|Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months|The adult lifestyle and function interview (ALFI) version of the mini-mental status exam (MMSE) measures neurological status. The ALFI-MMSE has 23 items. It is scored from 0 to 22, with lower scores interpreted as being worse.|6 months post hospital discharge|ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.|||units on a scale||Standard Deviation|Mean
1265617|NCT00394706|Secondary|Modified Rankin Score at 6 Months After Hospital Discharge|The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).|6 months post hospital discharge|ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.|||units on a scale||Standard Deviation|Mean
1265618|NCT00394706|Secondary|Survival to Hospital Discharge||Survival to hospital discharge or death before discharge|Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.|||participants|||Number
1265619|NCT00394706|Primary|Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).|The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.|Hospital discharge or death prior to discharge|Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.|||participants|||Number
1265620|NCT00394654|Secondary|Terminal Phase Volume of Distribution (Vz)|Vz of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Liter||Geometric Coefficient of Variation|Geometric Mean
1265621|NCT00394654|Secondary|Total Body Clearance (CL)|CL of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Liter per day||Geometric Coefficient of Variation|Geometric Mean
1265622|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained|||Day||Geometric Coefficient of Variation|Geometric Mean
1265623|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained|||Day||Geometric Coefficient of Variation|Geometric Mean
1265624|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Day||Geometric Coefficient of Variation|Geometric Mean
1265625|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained|||Percent||Geometric Coefficient of Variation|Geometric Mean
1265626|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained|||Percent||Geometric Coefficient of Variation|Geometric Mean
1265627|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Percent||Geometric Coefficient of Variation|Geometric Mean
1265628|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained|||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
1265629|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained|||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
1265630|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
1265631|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528|||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
1265632|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528|||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
1265642|NCT00394654|Secondary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
1265643|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56|Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 56|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
1265644|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28|Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 28|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
1265645|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7|Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 7|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
1265646|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56|Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 56|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
1265647|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28|Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 28|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
1265648|NCT00394654|Primary|Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7|Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 7|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
1265649|NCT00394589|Primary|Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score.|Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).|Between Screening (Week <=1) and Week 24|Intent-to-treat population; subjects with available data at both Baseline and Week 24|||Score on a Scale||Standard Deviation|Mean
1265650|NCT00394524|Secondary|Mean Hospital Length of Stay in Days Among the Glucommander Group Compared to Standard Insulin Infusion|mean number of days the patients stayed in the hospital are measured among the Glucommander group and standard insulin infusion and compared|During the complete length of hospitalization, up to 60 days||||days||Standard Deviation|Mean
1265651|NCT00394524|Secondary|Mean Length of Intensive Care Unit (ICU) in Days Stay Among Glucommander Group Compared to Standard Insulin Infusion Group|Mean number of days, the patients stayed in the intensive care unit are measured among glucommander group and standard insulin infusion group.|During ICU hospitalization, up to 30 days||||days||Standard Deviation|Mean
1265652|NCT00394524|Secondary|Number of Patients With Severe Hypoglycemia Episodes Among the Glucommander Group Compared to Standard Algorithm|Severe hypoglycemia is defined as the blood glucose (BG) levels lower than 40 mg/dL. The number of patients enrolled among both groups with the reports of having the BG levels lower than 40 mg/dL are recorded for duration of 10 days|First 10 days of ICU stay||||Participants|||Count of Participants
1265653|NCT00394524|Primary|Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion|Daily mean blood glucose concentrations during insulin infusion with the Glucommander and a standard paper form insulin infusion algorithm are measured every day up until 10 days and a mean values of these levels are calculated. The Mean blood glucose concentrations are measured once the target blood glucose levels are achieved after admission|First 10 days of ICU stay||||mg/dl||Standard Deviation|Mean
1265654|NCT00394472|Secondary|Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule||An interval of one to two hours after the first intake of AZD3355 65 mg capsule||||μmol/L||Standard Deviation|Mean
1265655|NCT00394472|Primary|Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms ‘a Burning Feeling Behind the Breastbone’ and ‘Unpleasant Movement of Material Upwards From the Stomach’ During the Last Seven Days of Treatment|Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary|Twice daily during the last seven days on treatment||||Participants|||Number
1265656|NCT00394433|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).|The analysis dataset is comprised of all enrolled patients.|||months||95% Confidence Interval|Median
1265657|NCT00394433|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.|Patients in the study cohort were followed for a median of 12.2 month (up to 40 months).|The analysis dataset is comprised of all enrolled patients.|||months||95% Confidence Interval|Median
1265658|NCT00394433|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).|The analysis dataset is comprised of all treated and evaluable patients.|||participants|||Number
1265659|NCT00394433|Primary|10-month Progression-Free Survival Rate|10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.|The analysis dataset is comprised of all enrolled patients.|||probability (%)||95% Confidence Interval|Number
1265660|NCT00394355|Secondary|Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).|Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward)|Baseline and up to ~ one year of treatment||||percentage of FEV1||Standard Deviation|Mean
1265661|NCT00394355|Secondary|Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants|||percentage of BMD||Standard Deviation|Mean
1265662|NCT00394355|Secondary|Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants|||percentage of BMD||Standard Deviation|Mean
1265663|NCT00394355|Primary|Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants|||percentage of BMD||Standard Deviation|Mean
1265664|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Asthma Control Test (ACT)|The ACT consisted of five questions, each ranging from 1 (worst) to 5 (best). The five questions were summed to yield an overall score that ranged from 5 (worst) to 25 (best).|The ACT was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
1265665|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Asthma-specific Quality of Life Assessment|The asthma-specific quality of life scale ranged from 1 (worst) to 7 (best)|The asthma-specific quality of life assessment was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
1265666|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Exhaled Nitric Oxide (eNO) Measured in Parts Per Billion||eNO was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||parts per billion||Standard Error|Least Squares Mean
1265667|NCT00394329|Secondary|Change Between Week 44 and Week 0 Peak Expiratory Flow Rate (PEFR) Variability|PEFR variability represents the relative change between the evening and morning PEFR measurements, so it could be a positive or negative number. It was measured daily during the 44-week treatment period. Specifically, the PEFR variability on a specific day is defined as 100% x (evening PEFR - morning PEFR)/{0.5*(evening PEFR + morning PEFR)}|PEFR variability was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||relative change (AM and PM peak flow)||Standard Error|Least Squares Mean
1265668|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Evening Peak Expiratory Flow Rate Variability (PEFR)||Evening PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||liters per minute||Standard Error|Least Squares Mean
1265669|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Morning Peak Expiratory Flow Rate (PEFR)||Morning PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||liters per minute||Standard Error|Least Squares Mean
1266295|NCT00389064|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score|HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
1265670|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV!)||Pre-bronchodilator FEV1 was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||liters||Standard Error|Least Squares Mean
1265671|NCT00394329|Secondary|Change Between Week 44 and Week 0 in Rescue Albuterol Puffs Per Day||Rescue albuterol puffs were measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||count of the number of puffs per day||Standard Error|Least Squares Mean
1265672|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Asthma Control Days||An asthma control day was determined daily during each of the 44-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||proportion of asthma control days||Standard Error|Least Squares Mean
1265673|NCT00394329|Primary|Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy||Measured during the 44-week treatment period|All randomized participants were included in the time-to-event analysis|||participants||95% Confidence Interval|Number
1265674|NCT00394277|Secondary|SVR-12 (Actual Treatment Period)|SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.|12 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)|||Percentage of patients|||Number
1265675|NCT00394277|Secondary|SVR-12 (Scheduled Treatment Period)|SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).|12 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)|||Percentage of patients|||Number
1265676|NCT00394277|Secondary|SVR-24 (Actual Treatment Period)|SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.|24 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)|||Percentage of patients|||Number
1265677|NCT00394277|Primary|Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)|SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).|Week 72|Intent-to-treat population (all patients treated with at least one dose of either study medication)|||Percentage of patients|||Number
1265678|NCT00394251|Primary|Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy|"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.~Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 6 months after chemotherapy (month 10).~Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 6 months after chemotherapy (month 10)."|Month 10|Participants in the Treated Population for whom safety data was available 6 months post-chemotherapy|||participants|||Number
1265679|NCT00394251|Secondary|Summary of Participants’ Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles)|"Summary of the most severe grades using the National Cancer Institute’s Common Terminology Criteria for Adverse Events v3.0 (CTCAE) for the following liver and renal function tests.~Grade 0 = within normal range for all measurements.~Alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST):~Grade 1 = > upper limit of normal (ULN) – 2.5*ULN~Grade 2= >2.5-5.0*ULN~Grade 3= >5.0-20.0*ULN~Grade 4= >20.0*ULN~Bilirubin:~Grade 1= >ULN – 1.5*ULN~Grade 3= >3.0 – 10.0*ULN~Creatinine:~- Grade 1= >ULN – 1.5*ULN"|Week 1 up to week 50|Treated population with at least one post-treatment laboratory measure.|||participants|||Number
1265680|NCT00394251|Secondary|Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation|Decreased left ventricular ejection fraction (LVEF) is an indication of cardiotoxicity. Change from baseline measurements to the final evaluation are summarized.|up to week 46|Participants in the treated population who had both baseline and one treatment measurement for %LVEF|||percentage of healthy LVEF||Full Range|Median
1265681|NCT00394251|Secondary|Myelosuppression During Taxane Dosing Cycles|"Myelosuppression represented by neutropenia (low absolute neutrophil counts (ANC)) with severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).~Grade 1 = <lower limit of normal (LLN)-1.5*10^9/L~Grade 2 = <1.5 - 1.0*10^9/L~Grade 3 = <1.0 - 0.5*10^9/L~Grade 4 = <0.5*10^9/L~Values are reported across all severity grades without assessment of relationship to taxane treatment, and also by relation to taxane treatment as reported by investigators."|Weeks 9-16|Participants in the treated population who received at least 1 dose of taxane and had laboratory values.|||participants|||Number
1265682|NCT00394251|Secondary|Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays|"Counts of participants who~completed the protocol-defined treatment cycles,~had a dose interruption~had a dose reduction~had a dose delay. A dose delay refers to the delay of all interventions in the cycle.~Dose modifications are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.~Use of pegfilgrastim is included in the summary."|up to Week 46|Treated population|||participants|||Number
1265683|NCT00394251|Secondary|Percent of Protocol Taxane Dose|Percent of the protocol-defined taxane (ABI-007 or Taxol) dose that was actually taken by study participants.|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.|||percentage of protocol-defined taxane||Standard Deviation|Mean
1265684|NCT00394251|Primary|Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy|"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.~Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7).~Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7)."|Month 7|Participants in the Treated Population for whom safety data was available 3 months post-chemotherapy|||participants|||Number
1265685|NCT00394251|Secondary|Mean Taxane Dose Intensity Per Week|Cumulative taxane (ABI-007 or Taxol) dose divided by the number of weeks on taxane treatment.|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.|||mg/m^2/week||Standard Deviation|Mean
1265686|NCT00394251|Secondary|The Cumulative Dose of Taxane Delivered During Study|The cumulative dose of taxane (Taxol or ABI-007) taken during the study (cycles 4-8 which is approximately weeks 9-16).|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.|||mg/m^2||Standard Deviation|Mean
1265687|NCT00394212|Secondary|Subjects Achieving 20% Excess Weight Loss at 6 Months|%Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100|6 months|ITT, Last Observation Carried Forward|||percentage of participants|||Number
1265688|NCT00394212|Secondary|Subjects Achieving Weight Stabilization at 6 Months|Weight is stabilized if 6 month weight is +/- 2% from baseline weight.|6 months|ITT, Last Observation Carried Forward|||percentage of participants|||Number
1265689|NCT00394212|Secondary|Subjects Achieving 15% Excess Weight Loss (EWL)|%Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.|6 months|ITT, Last Observation Carried Forward|||percentage of participants|||Number
1265690|NCT00394212|Primary|Weight Loss (%)|Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100|6 months|ITT using Last Observation Carried Forward (LOCF)|||percentage of weight lost||Standard Deviation|Mean
1265691|NCT00394095|Primary|Change in Body Weight|For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.|12 weeks|Bipolar youth (ages 12-17) who were taking olanzapine (10-20 mg/day) for a manic episode, were given topiramate (300-400mg/day) or comparable dose placebo for 12 weeks. Analysis was per protocol.|||kg||95% Confidence Interval|Mean
1265692|NCT00394095|Secondary|Tolerability of Topiramate|To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.|12 weeks|||||||
1265693|NCT00394095|Primary|Change in Body Mass Index (BMI)|For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.|12 weeks|The analysis was per protocol based on change in BMI over 12 weeks in the Experimental sample (N=16) compared to the Placebo group (N=14).|||kg/m2||95% Confidence Interval|Mean
1265694|NCT00394082|Secondary|Kaplan-Meier Estimates for Participant Survival|Participant survival is the time from the first dose of study drug to patient death from any cause. Patients that did not die were censored at the last known time the patient was alive.|up to 39 months|Treated population|||months||95% Confidence Interval|Median
1265695|NCT00394082|Secondary|Kaplan-Meier Estimate for Duration of Response|"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease is defined in outcome #2. Complete response (CR) and partial response (PR) are defined in outcome #3."|up to 39 months|Treated population of participants who had a response.|||months||95% Confidence Interval|Median
1265696|NCT00394082|Secondary|Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). RECIST defines SD as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease and no new lesions. Definitions for CR and PR can be found in outcome #3.|up to 39 months|Treated population|||percentage of participants||95% Confidence Interval|Number
1265697|NCT00394082|Secondary|Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response is complete response (CR) + partial response (PR). RECIST defines overall response of CR as the disappearance of all target and non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. Overall response of PR is defined as >= 30% decrease from baseline in the sum of the longest diameters of target lesions and no progression of non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing and no appearance of new lesions. The objective response is determined by combining the response of target and non-target lesions and the appearance of new lesion(s) or not together.|up to 39 months|Treated population.|||percentage of participants||95% Confidence Interval|Number
1265723|NCT00393796|Primary|Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo|"The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy.~Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 Months Post Treatment||||percentage of participants||95% Confidence Interval|Number
1265698|NCT00394082|Primary|Kaplan-Meier Estimates for Progression-free Survival|"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first. Patients who do not have disease progression or have not died at the end of follow-up were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Response Evaluation Criteria in Solid Tumors (RECIST) defines progressive disease (PD) as a >= 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to 39 months|Treated population.|||months||95% Confidence Interval|Median
1265699|NCT00394082|Primary|Participants With At Least One Treatment-Emergent Adverse Event (TEAE)|Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.|up to 25 months|Safety population|||participants|||Number
1265700|NCT00393978|Primary|Change in Percent Days of Cannabis Use Per Week|Change in percent days of cannabis use per week from baseline to week 16.|16 weeks||||cannabis use||Standard Deviation|Mean
1265701|NCT00393978|Primary|Change in Joints Per Week|Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.|16 weeks||||joints||Standard Deviation|Mean
1265702|NCT00393939|Secondary|Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score|EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled ‘best imaginable health state’ and ‘worst imaginable health state’. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.|||units on a scale||95% Confidence Interval|Mean
1265703|NCT00393939|Secondary|Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score|EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.|||units on a scale||95% Confidence Interval|Mean
1265704|NCT00393939|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score|EORTC QLQ-C30 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.|||units on a scale||95% Confidence Interval|Mean
1265705|NCT00393939|Secondary|Overall Survival (OS)|Time from randomization to date of death due to any cause. OS calculated as (Months) = (death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.|Baseline to date of death from any cause (up to Month 33)|ITT population|||months||95% Confidence Interval|Median
1265706|NCT00393939|Secondary|Duration of Response (DR)|DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|Baseline up to Month 33|ITT population. Number of participants analyzed = number of participants with confirmed objective tumor response.|||months||95% Confidence Interval|Median
1265707|NCT00393939|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (≥30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.|Baseline up to Month 33|ITT population|||percentage of participants|||Number
1265708|NCT00393939|Primary|Progression-Free Survival (PFS)|PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.|Baseline up to Month 33|Intent-to-Treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
1265724|NCT00393718|Secondary|Hypoglycaemic Episodes|Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|over 52 weeks of treatment|Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.|||number of events per year of exposure|||Number
1266512|NCT00386360|Secondary|Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1265709|NCT00393913|Primary|Vigilance|Vigilance is measured using the psychomotor vigilance task which is a portable reaction time test that is contained in a small, programmable, portable electronic box that requires only a single switch to start. The task consists of responding to a small bright red light stimulus by pressing a response button as soon as the stimulus appears. This stops the stimulus counter and displays the reaction time (RT) in milliseconds for a 2-second period and the task duration is 20 minutes. The subject is instructed to press the button as soon as each stimulus appears in order to keep the reaction time as low as possible. The PVT yields highly informative metrics on the capacity for sustained attention including the frequency of lapses (reaction time > 500 milliseconds). The higher the number of lapses the greater the impairment. Well rested (non-sleepy) subjects have almost no lapses(<2) during the 20min test.|Baseline, CPAP (4-6 weeks), CPAP withdrawal (2 nights)|Per protocol|||Lapses||Standard Deviation|Mean
1265710|NCT00393913|Primary|Objective Sleepiness|Multiple Sleep Latency Test (MSLT) measures the latency to sleep onset in minutes. The shorter the latency to sleep the more sleepy the subject.|Measured at baseline, on CPAP (4-6 weeks), CPAP withdrawal (2 nights)||||minutes||Standard Deviation|Mean
1265711|NCT00393913|Primary|Subjective Sleepiness|Measured using the Epworth sleepiness scale (ESS). The Epworth sleepiness scale is used in the assessment of daytime sleepiness and measures the general level of sleepiness.The ESS presents the subject with eight situations and asks how likely they are to fall asleep (0= never, 1 =slight chance of dozing, 2= moderate chance of dozing and 3 =high chance of dozing) in these situations. The sum of the 8 answers is used as the score and ranges from 0 (not sleepy) to 24 (extremely sleepy), and a score of greater than 10 is an indication that a person may be excessively sleepy.|Baseline, CPAP( 4 -6 weeks), Off CPAP ( 2 nights)||||units on a scale||Standard Deviation|Mean
1265712|NCT00393887|Primary|Number of Patients With Inguinal Hernia Recurrence||1 year||||participants|||Number
1265713|NCT00393874|Primary|PSQI|"Self-report sleep quality measure. Scores range between 0 and 21, with higher scores reflecting poor sleep quality.~A score of < or = to 5 reflects good sleep quality."|Baseline, post, 4 months post-treatment|For the medication arm, 18 participants completed PSQI at screening, 14 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.|||units on a scale||Standard Deviation|Mean
1265714|NCT00393874|Primary|PSG Composite Measure|"Sleep Efficiency (SE) is the ratio of total time spent asleep over total time spent in bed.~For PSG studies, (SE) typically vary between 50% and 95%. Greater values indicated more consolidated sleep."|Baseline sleep study and post sleep study|For the medication arm, 18 participants completed a PSG study at baseline and 13 completed a PSG post treatment. For the Behavioral arm, 17 participants completed a PSG at baseline and 12 completed a PSG post-treatment. For the placebo arm, 15 participants completed a PSG at baseline and 12 completed a PSG post-treatment.|||percentage of time asleep vs time in bed||Standard Deviation|Mean
1265715|NCT00393874|Primary|Sleep Diary Measures|"Sleep diary SE, nightmare frequency Sleep diary sleep efficiency can range from 0 to 100%, and typically varies between 50% and 95%. Higher % values reflect greater sleep consolidation, i.e., greater ratio of time asleep/time in bed.~Nightmare frequency varies between 0 and no upper limit is provided. Greater frequency of nightmares reflects greater nightmare severity."|baseline and post|For the medication arm, 15 participants completed the sleep diary (SD) at baseline and 13 returned a SD post treatment. For the Behavioral arm, 15 participants completed the SD at baseline, and 12 returned it at follow-up. For the placebo arm, 12 participants completed the diary at baseline and 10 returned one at follow-up.|||units on a scale||Standard Deviation|Mean
1265716|NCT00393874|Primary|Insomnia Severity Index|Self-report measures of insomnia severity. Scores range from 0 to 28, with higher scores indicated more severe insomnia. A score < 8 is considered to reflect no significant insomnia.|Screening, Post, and Follow-up|For the medication arm, 18 participants completed ISI at screening, 15 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.|||units on a scale||Standard Deviation|Mean
1265717|NCT00393861|Secondary|Overall Survival|Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|completion of study, up to 5 years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
1265718|NCT00393861|Secondary|Duration of Remission (CR + PR)|Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.|completion of study, up to 5 years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
1265719|NCT00393861|Secondary|Objective Response Rate (Complete and Partial Response)|The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|completion of study, up to 5 years|All patients enrolled and received treatment.|||percentage of participants||90% Confidence Interval|Number
1265720|NCT00393861|Primary|Twelve Month Disease-free Survival Rate|The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.|12 month post completion of treatment|All patients enrolled and received treatment.|||percentage of participants||90% Confidence Interval|Number
1265721|NCT00393848|Secondary|Change in Maximal Voluntary Contraction||Baseline and 6 weeks post surgery|Measure not performed in Experiment 2|||kg/kg leg lean mass||Standard Error|Mean
1265722|NCT00393848|Primary|Muscle Protein Synthesis||Perioperative and discharge||||%/d||Standard Error|Mean
1265725|NCT00393718|Secondary|Body Weight After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||kg||Standard Error|Least Squares Mean
1265726|NCT00393718|Secondary|Body Weight After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||kg||Standard Error|Least Squares Mean
1265727|NCT00393718|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265728|NCT00393718|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265729|NCT00393718|Secondary|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265730|NCT00393718|Secondary|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265731|NCT00393718|Secondary|Postprandial Glucose AUC After 52 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL *h||Standard Error|Least Squares Mean
1265732|NCT00393718|Secondary|Postprandial Glucose AUC After 24 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL *h||Standard Error|Least Squares Mean
1265733|NCT00393718|Secondary|Fasting Plasma Glucose After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265734|NCT00393718|Secondary|Fasting Plasma Glucose After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
1265735|NCT00393718|Secondary|Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
1265736|NCT00393718|Primary|Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
1265737|NCT00393705|Secondary|Total Daily Insulin Dose at 4 Weeks and 12 Weeks||4 weeks and 12 weeks|Number of patients who received at least one dose of study drug and had a post-baseline insulin measurement at week 4 and week 12.|||International Units (IU)||Standard Deviation|Mean
1265738|NCT00393705|Secondary|Change From Baseline in Weight at 16 Week Endpoint||Baseline, 16 weeks|Number of patients who received at least one dose of study drug and had at least one post-baseline weight value at week 16.|||kilograms (kg)||Standard Deviation|Mean
1265739|NCT00393705|Secondary|30-Day Adjusted Rate of Hypoglycemic Events|Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.|Baseline through 16 weeks|Number of patients who received at least one dose of study drug and had at least one assessment after randomization.|||number of events per 30 days||Standard Deviation|Mean
1265848|NCT00392834|Primary|Overall Survival (OS) at 1 Year||1 year post treatment||||Cumulative proportion surviving at 1 yr||95% Confidence Interval|Number
1265740|NCT00393705|Secondary|Number of Patients With Self-reported Hypoglycemic Episodes|Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.|Baseline through 16 weeks|Number of patients who received at least one dose of study drug and had at least one assessment after randomization.|||participants|||Number
1265741|NCT00393705|Secondary|Mean Daily Blood Glucose Values at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline blood glucose reading at week 16 for the respective variable.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1265742|NCT00393705|Secondary|Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint|Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16.|16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial blood glucose reading after the midday meal at week 16.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1265743|NCT00393705|Secondary|2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint|Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16.|16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial plasma glucose reading after the midday meal at week 16.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1265744|NCT00393705|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint||Baseline, 16 Weeks|Number of patients who received at least one dose of study drug and a post-baseline HbA1c value at endpoint.|||percent HbA1c||Standard Deviation|Mean
1265745|NCT00393705|Secondary|Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline HbA1c value at endpoint.|||percentage of participants|||Number
1265746|NCT00393705|Primary|Hemoglobin A1c (HbA1c) at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had an HbA1c measure at endpoint.|||percent HbA1c||Standard Deviation|Mean
1265747|NCT00393523|Other Pre-specified|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy|Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
1265748|NCT00393523|Other Pre-specified|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy|Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
1265749|NCT00393523|Secondary|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy|Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.|||Participants|||Number
1265750|NCT00393523|Primary|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy|Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.|||Participants|||Number
1265751|NCT00393510|Secondary|Time of Ulcer Healing|Time taken for maturation of granulation to enable skin grafting.|24 week||||Weeks||Standard Deviation|Mean
1265752|NCT00393510|Secondary|Tumour Necrosis Factor-alpha Levels in Serum|The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.|Baseline and 4 week||||pg/mL||Standard Deviation|Mean
1265753|NCT00393510|Primary|Number of Participants With Limb Salvage|The number of successful limb rescued (without amputation).|24 weeks||||Participants|||Number
1265754|NCT00393484|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96|ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).|Start of dosing (Day 1) until Week 96|Randomized participants who received at least 1 dose of study drug and who were evaluable.|||Participants|||Number
1265755|NCT00393484|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Start of dosing (Day 1) until end of treatment (Week 240) + 5 days|Participants who were randomized and received at least 1 dose of study drug|||Participants|||Number
1265756|NCT00393484|Secondary|Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96|Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement).|At 96 weeks|All participants who received study drug and who had samples of measureable HBV DNA values|||Participants|||Number
1265757|NCT00393484|Secondary|Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240|Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay|At Weeks 48, 96, 144, 192, and 240|Randomized participants who received at least 1 dose of study drug|||Percetage of participants|||Number
1265758|NCT00393484|Secondary|Number of Participants With Virologic Rebound at Week 24|Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement).|At Week 24||||Participants|||Number
1265759|NCT00393484|Secondary|Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24|Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate.|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
1265760|NCT00393484|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24|ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
1265761|NCT00393484|Secondary|Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24|ALT flares=ALT>2*Baseline and 10*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status.|Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
1265762|NCT00393484|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Most common AEs=AEs affecting ≥3 participants. Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status.|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period|Treated cohort: includes participants who are randomized and received at least 1 dose of study drug (ETV or LVD).|||Participants|||Number
1265763|NCT00393484|Secondary|Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96|Normalization of serum ALT= ≤*institutional upper limit of normal.|At Weeks 24, 48, and 96|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
1265764|NCT00393484|Secondary|Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24|Mean ALT values from baseline by laboratory test. .|At Week 24|Randomized participants who received at least 1 dose of study drug|||U/L||Standard Deviation|Mean
1265765|NCT00393484|Secondary|Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240|Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24. The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay.|At Weeks 24, 48, 96, 144, 192, and 240|Randomized participants who received at least 1 dose of study drug|||log10 copies/mL||Standard Deviation|Mean
1265766|NCT00393484|Secondary|Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96|The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay. Treatment comparisons will be assessed using the same method as the primary endpoint.|At Weeks 24, 48, and 96|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
1265767|NCT00393484|Primary|Percentage of Participants Who Achieved a Virologic Response at Week 24|Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay.|At Week 24|Randomized participants who received at least 1 dose of study drug|||Percentage of participants|||Number
1265768|NCT00393458|Secondary|Percentage of Days of Poor Control During 52 Weeks of Treatment|Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|Baseline to end of study (Week 52)|Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.|||Percentage of days||Standard Error|Least Squares Mean
1265769|NCT00393458|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|Week 12 + 1 day, Day 85|Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.|||Liters||Standard Error|Least Squares Mean
1265770|NCT00393380|Secondary|Disease-free Survival|Disease-free survival|Measured at 1 year|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
1265771|NCT00393380|Secondary|Overall Survival|Overall Survival|Measured at 2 years|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
1265772|NCT00393380|Secondary|Cumulative Incidence of Relapse|Cumulative Incidence of Relapse|Measured at 2 years|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
1265773|NCT00393380|Secondary|100-day Transplant-related Mortality|100-day transplant-related mortality|Measured at Day 100|13 patients were transplanted|||participants|||Number
1265774|NCT00393380|Secondary|Platelet Engraftment (Greater Than 20,000)|Platelet engraftment (greater than 20,000)|Measured at Day 180|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
1265775|NCT00393380|Secondary|Cumulative Incidence of Chronic GVHD|Cumulative Incidence of Chronic GVHD|Measured at 2 years|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
1265776|NCT00393380|Secondary|Cumulative Incidence of Acute GVHD Grades II-IV at Day 100|Cumulative Incidence of Acute GVHD Grades II-IV at day 100|Measured at Day 100|13 patients were transplanted|||percentage of participants||95% Confidence Interval|Number
1265777|NCT00393380|Primary|Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)|Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)|Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.|13 patients received the transplant.|||days||Full Range|Median
1265778|NCT00393367|Secondary|Serious Adverse Events|Serious Adverse Events|0-5 days|89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.|||participants|||Number
1265779|NCT00393367|Secondary|Number of Participants With Adverse Events (Non-serious).||within 30 days of the ED visit|Of the 180 patients randomized, 91 were to BIS, 89 were to placebo. Two patients were lost to follow-up in the BIS group and 4 in the placebo group.|||Participants|||Number
1265780|NCT00393367|Primary|Mean Change in Asthma Score at 2 Hours|The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.|Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator|88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).|||Units on a scale||95% Confidence Interval|Mean
1265781|NCT00393367|Secondary|Relapse / Readmission Numbers.|Participants admitted to the hospital within 5 days of the ED visit|within 5 days of ED visit|89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.|||Participants|||Number
1265782|NCT00393367|Secondary|Number of Subjects Moving From the Severe Asthma to Mild Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.|||Participants|||Number
1265783|NCT00393367|Secondary|Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.|||Participants|||Number
1265849|NCT00392821|Secondary|Progression-Free Survival.|Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions.|18 months||||Months||95% Confidence Interval|Median
1265784|NCT00393367|Secondary|Number of Subjects Remaining in the Severe Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who remained in that category 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.|||Participants|||Number
1265785|NCT00393367|Secondary|Oxygen Saturation.|Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment.|2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator||||Percent Hemoglobin Saturation||95% Confidence Interval|Mean
1265786|NCT00393367|Secondary|Mean Change in Respiratory Rate.|Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.|Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator||||Breaths per minute||95% Confidence Interval|Mean
1265787|NCT00393367|Secondary|Change in Mean Heart Rate|Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol|From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator||||Beats per minute||95% Confidence Interval|Mean
1265788|NCT00393367|Secondary|Number of Patients Hospitalized|The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.|within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo||||Participants|||Number
1265789|NCT00393367|Primary|Median Change in Asthma Score 2 Hours After Intervention|The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.|Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator|88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).|||Units on a scale||Full Range|Median
1265790|NCT00393094|Primary|Radiographic Response Rate (Glioblastoma Multiforme Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)||||Percent of participants|||Number
1265791|NCT00393094|Primary|Radiographic Response Rate (Anaplastic Glioma Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.|||Percent of participants|||Number
1265792|NCT00393094|Primary|Number of Participants With Toxicity as Measured by The National Cancer Institute (NCI) Common Toxicity Criteria v. 3.0.|Here is the number of participants with any toxicity, defined as any adverse events possibly, probably or definitely related to the investigational drugs. For the detailed list of investigational new drug (IND)-related toxicities and other serious adverse events, see the adverse event module.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.|||Participants|||Number
1265793|NCT00393094|Primary|Radiographic Response Rate (Malignant Glioma Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.|||Percent of participants|||Number
1265794|NCT00393068|Secondary|Overall Survival||32 months|||||||
1265795|NCT00393068|Secondary|Progression-Free Survival||32 months|||||||
1265796|NCT00393068|Primary|Pathologic Complete Response (pCR) Rate||18 months||||participants|||Number
1265850|NCT00392821|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment||18 months||||percentage of evaluable patients||95% Confidence Interval|Number
1265851|NCT00392808|Primary|Serum Antibody Titers Against Haemophilus Influenzae Type b.||One year||||GMCs||95% Confidence Interval|Geometric Mean
1265852|NCT00392808|Primary|Serum Bactericidal Activity Against MenC||One month after booster dose||||GMTs||95% Confidence Interval|Geometric Mean
1265797|NCT00393042|Secondary|Weiss Functional Impairment Rating Scale (WFIRS)|The WFIRS consists of 50 questions where respondents are asked to rate their child's functional impairment. The items of the WFIRS are scored on a four point Likert-type rating scale: 0 (never or not at all), 1 (sometimes or somewhat), 2 (often or much) or 3 (very often or very much) and aggregated to produce six domain scores: Family (ranges between 0-24), Learning or School (ranges between 0-33), Self-Concept (ranges between 0-15), Social Activities (ranges between 0-27), Life Skills (ranges between 0-36), and Risky Activities (ranges between 0-42). The subscales are scored by summing the responses in the subsection. The Total score is the sum of all the responses and it ranges between 0-150. The higher the score in each of the subscales the more impairment is recorded, this is also true for the total score.|8-10 weeks|The number of participants analyzed differs from the participant flow in all of the groups besides the Adderall XR - 10mg group because the WFIRS was not completed for every participant.|||units on a scale||Standard Deviation|Mean
1265798|NCT00393042|Secondary|Clinical Global Impression - Severity|The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|8-10 weeks|The number of participants analyzed differs from the participant flow in the Focalin XR groups because the CGI-S was not completed for every participant. The same is true for the Adderall XR - 25/30mg group.|||units on a scale||Standard Deviation|Mean
1265799|NCT00393042|Secondary|Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms|Three variations of the DAT 1 gene were observed, the 9/9 allele, the 9/10 allele and the 10/10 allele. The ADHD Rating Scale (ADHD-RS) and Clinical Global Impressions - Severity (CGI-S) measures were used to evaluate how the DAT 1 gene allele type altered the efficacy of the medication. The DAT 1 genotype did not predict differential response to Focalin XR or Adderall XR so the dose levels of each drug was combined to examine how the genotype interacted with the dose level. The ADHD-RS evaluates the severity of the participant's ADHD symptoms and includes two subscales: Inattention and Hyperactivity/Impulsivity. Both subscale scores range from 0 to 27 with a higher score representing more severe symptoms. The subscales are summed to calculate the total score which can range from 0 to 54. The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|8-10 weeks|The number of participants analyzed differs from the participant flow because some participants refused to provide a DNA sample for analysis or some participants did not have the allele type that was being observed. Of those that provided a DNA sample, 6 had the 9/9 allele on the DAT 1 gene, 15 had the 9/10 allele and 30 had the 10/10 allele.|||units on a scale||Standard Deviation|Mean
1265800|NCT00393042|Secondary|ADHD Parent Rating Scale-IV|Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.|completed weekly over 8-10 weeks||||units on a scale||Standard Deviation|Mean
1265801|NCT00393042|Primary|Sleep Duration|Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep.The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.|8-10 weeks|participants with sufficient sleep actigraphy data for analysis (n=37)|||minutes||Standard Deviation|Mean
1265802|NCT00393042|Primary|Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.|Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep. The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.|8-10 weeks|Subjects with complete and valid actigraphy (n = 37) and sleep diaries were used to calculate sleep onset latency and sleep duration.|||HHMM.SS||Standard Deviation|Mean
1265803|NCT00393029|Secondary|In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants|Survival of TCR gene-engineered cells is defined as >10% murine TCR positive cells.|3-12 months||||participants|||Number
1265804|NCT00393029|Primary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. Adverse events were described using the Common Terminology Criteria for Adverse Events (CTCAE) version 3. For the detailed list of adverse events see the adverse event module.|events related to all components of the treatment regimen were reported from the start of the non-myeloablative conditioning regiment through 30 days following treatment or resolution.||||participants|||Number
1265805|NCT00393029|Primary|Clinical Tumor Regression|"Response Evaluation Criteria In Solid Tumors (RECIST).~See the protocol Link module for full criteria if desired."|1-11 months||||Participants|||Number
1265853|NCT00392782|Secondary|Overall Survival|Number of patients who were deceased at 1 year post transplant.|1 Year||||Participants|||Number
1265854|NCT00392782|Secondary|Transplant-related Mortality|Number of patients with treatment related death at 1 year post transplant.|1 Year||||Participants|||Number
1265855|NCT00392782|Secondary|Incidence of Graft Failure|Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days.|Day 100||||Participants|||Number
1265806|NCT00392951|Secondary|Number of Participants With Lymphoproliferation Response to Oral Sirolimus|Complete response (CR) is complete resolution of any lymphadenopathy and splenomegaly for at least two months. Partial response (PR) is a reduction in size of at least 50% of lymphadenopathy or splenomegaly for at least two months. No response (NR) is no change or < 50% reduction in lymphadenopathy or splenomegaly. Progressive Disease (PD) is obtaining a CR or PR by the 3 month observation and relapsing or progressing by the 6 month observation, leading to cessation of study drug. Not Applicable (N/A) is there is no evidence of disease (No pathologic lymphadenopathy or splenomegaly at time of enrollment).|6 months|Number analyzed per row reflects number of participants with each condition|||Participants|||Count of Participants
1265807|NCT00392951|Secondary|Effect of Sirolimus on Intracellular Targets|Needs more specific information|6 months|This was an optional assessment- there was no enrollment. Data were not collected.||||||
1265808|NCT00392951|Secondary|Trough Levels Produced by Administration of Oral Sirolimus|Pharmacokinetic levels produced by administration of oral sirolimus|Within first 5 days of starting sirolimus||||nanograms/dL||Full Range|Mean
1265809|NCT00392951|Secondary|Number of Participants With Autoimmune Disease Response to Oral Sirolimus|Complete response (CR) is complete resolution in all autoimmune cytopenias (neutropenia, anemia thrombocytopenia) maintained for more than two months, combined with an ability to wean off corticosteroids and/or other immunosuppressive medication. Partial response (PR) is improvement in any cytopenias by at least one grade, lasting more than two months, without worsening any other cytopenias or stable disease with the ability to wean corticosteroids and/or immunosuppressive medications by at least 50%. No response (NR) is no change in cytopenias with treatment, and the inability to wean corticosteroids or other immunosuppressive medications. Progressive disease (PD) refers to obtaining a CR or PR by the 3 month observation and relapsing or progressing by the 6 month observation, leading to cessation of study drug.|6 months|Number analyzed per row reflects number of participants with each condition|||Participants|||Count of Participants
1265810|NCT00392951|Primary|Number of Participants With Grade 3 and 4 Toxicities of Administration of Oral Sirolimus|"Grade 3 toxicities are those that are considered severe or medically equivalent requiring hospitalization or prolonged hospitalization (according to CTCAE criteria 3.0).~Grade 4 toxicities are those that are life-threatening (urgent intervention indicated) (according to CTCAE criteria 3.0)."|6 months||||participants|||Number
1265811|NCT00392925|Secondary|Number of Participants With Treatment-emergent Anti-Leptin Antibodies by Week 4, Week 8, Week 12, Week 16 - Intent to Treat Population|Serum titer determinations for antibodies to leptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to leptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline. All participants were evaluated (including those who did not receive metreleptin as their randomized study drug). Baseline was Day 1 (randomization).|Baseline up to Week 16|The Intent-To-Treat (ITT) Population includes all randomized participants who received at least 1 injection of any component of the randomized study medication; n=number with non-missing data at visit in each treatment group.|||participants|||Number
1265812|NCT00392925|Secondary|Number of Participants With Clinically Significant Abnormal ECG at Weeks 16, 20, or Early Termination - Randomized Population|A 12-Lead electrocardiogram (ECG) was obtained at Week -4, Day 1, Week 16, Week 20 or early termination and the overall interpretation of the ECG was made by the investigator as normal, abnormal (not clinically significant) and abnormal (clinically significant). The ECG consisted of the PR interval = time from beginning of the P wave to the beginning of the QRS complex; (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS (time from the beginning to the end of the QRS complex) interval; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). .|Weeks 16, 20, early termination|All participants who were enrolled and randomized and had ECGs performed at Weeks 16, 20, or early termination. n=number of participants with ECGs at visit by treatment group.|||participants|||Number
1265813|NCT00392925|Secondary|Number of Hematology and Urinalysis Values of Potential Clinical Importance - Enrolled Population|Number of laboratory values of potential clinical importance (not participants) observed. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Time frame of evaluation differs depending on randomization status.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|The Enrolled Population includes all enrolled participants who received at least 1 dose of pramlintide during the 4-week lead-in period or who had nonmissing vital signs data at Week -4. n=number with non-missing data in each treatment group|||participants|||Number
1265814|NCT00392925|Secondary|Number of Chemistry Values of Potential Clinical Importance - Enrolled Population|Number of values (not participants). Greater than (>), Less than (<), high (H), low (L). Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin H > 2 mg/dL; glucose fasting or non-fasting H >200 mg/dL, L <60 mg/dL; Albumin L <2.5 g/dL; Creatine Phosphokinase (CPK) H >3*Upper limit of Normal (ULN); Sodium L<130 milliequivalents per liter (mEq/L), H >150 mEq/L; potassium L<3.0 mEq/L, H>5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8 mg/dL, H>11 mg/dL; triglycerides H>500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H >3*ULN; Gamma-glutamyltransferase (GGT) H>3*ULN; creatinine males >1.6 mg/dL, females >1.4 mg/dL; alanine aminotransferase (ALT) H >3*ULN; aspartate aminotransferase (AST) H >3*ULN; urea nitrogen H >45 mg/dL; uric acid males >10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L <1.0 mg/dL H >6.0 mg/dL. Time frame differs depending on randomization status.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|The Enrolled Population includes all enrolled participants who received at least 1 dose of pramlintide during the 4-week lead-in period or who had nonmissing data at Week -4. n=number with non-missing data in each treatment group who were in the analysis.|||laboratory values|||Number
1265815|NCT00392925|Secondary|Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Heart Rate - Enrolled Population|Enrollment was Visit 2 (Week -4). Heart rate was measured after the participant rested for 5 minutes and was sitting. Heart Rate was measured in beats per minute (bpm). Vital signs were taken at each visit (screening, Week -4, Week -2, Day 1, Weeks 4, 8, 12, 16, 20 (or early termination). After the Lead-In Period, participants were either randomized to one of the 3 arms of the study or they were dropped from the study so the time frame for evaluation of all participants in the study was either: enrollment up to Week 20 for Randomized participants or enrollment up to, but not including Day 1 for Non-Randomized participants who participated only in the Lead-In Period.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|ITT: those randomized, received at least 1 injection of any component of the randomized medication. Enrolled not randomized: those who received at least 1 dose of pramlintide in 4-week lead-in period. n=number with non-missing data at visit in each treatment group.|||beats/min||Standard Deviation|Mean
1265816|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Systolic and Diastolic Blood Pressure - Enrolled Population|Enrollment was Visit 2 (Week -4). Blood pressure (BP) was measured after 5 minutes of quiet rest with the participant in a sitting position and was measured in millimeters of mercury (mm Hg). Blood pressure was taken at each visit (screening, Week -4, Week -2, Day 1, Weeks 4, 8, 12, 16, 20 (or early termination). After the Lead-In Period, participants were either randomized to one of the 3 arms of the study or they were dropped from the study so the time frame for evaluation of all participants in the study was either: enrollment up to Week 20 for Randomized participants or enrollment up to, but not including Day 1 for Non-Randomized participants who participated only in the Lead-In Period.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|ITT:those randomized, received at least 1 injection of any component of the randomized medication. Enrolled not randomized: those who received at least 1 dose of pramlintide in 4-week lead-in period. n=number with non-missing data at visit in each treatment group.|||mm Hg||Standard Deviation|Mean
1265817|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Hospital Anxiety and Depression Scale (HADS) - Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The lower the score the more improvement a participant shows.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number with non-missing data in each treatment group were analyzed (n).|||units on a scale||Standard Error|Least Squares Mean
1265818|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcomes (PRO) for Eating Behavior - Evaluable Population|Enrollment was Visit 2 (Week -4). PRO for eating behavior: Binge Eating Scale (BES) Total Score (16-item questionnaire assessed the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Minimum and maximum scores were 0 and 55, respectively); Susceptibility to Eating Questionnaire (SEQ) Total Score (measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale [ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong]. Responses to these items rated over the past 7 days;|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.|||units on a scale||Standard Error|Least Squares Mean
1265819|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcome (PRO) Instruments Measuring Quality of Life and Mood - Evaluable Population|Enrollment was Visit 2 (Week -4). PRO: Total Score in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite), 31-item instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items range from 1 to 5 with 5=always true and 1= never true. Total score measured on scale from 0 (worst) to 100 (best). Higher scores indicate improvement; Profile of Mood States (POMS), 65 mood adjectives that assess participants' mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. Factor scores added for total score. Lower score indicates improvement. 0=best outcome; 120=worst outcome.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group. (POMS)n=19, 38, 36; (IWQOL-Lite)n=19, 38, 36|||units on a scale||Standard Error|Least Squares Mean
1265820|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Insulin - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Total insulin was measured in micro international units per milliliter (µIU/mL)|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.|||µIU/mL||Standard Deviation|Mean
1265821|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Amylin -Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Fasting total plasma amylin (peptide produced by beta cells in the pancreas) concentration was measured in picomolar (pM) and samples were obtained at screening, enrollment, baseline, Week 4 and Week 16.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number analyzed with non-missing data at visit.|||pM||Standard Deviation|Mean
1265822|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline, Weeks 4 and 16 in Fasting Total Leptin Concentration - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Leptin was measured in nanograms per milliliter (ng/mL). Plasma total leptin (including endogenous leptin and exogenous metreleptin) concentrations were measured using a validated sandwich-type immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. This assay is not specific for metreleptin and detects both endogenous leptin and exogenous recombinant-methionyl human leptin [metreleptin]).|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.|||ng/mL||Standard Deviation|Mean
1265823|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Week 16 in Fasting Glucose and Lipids - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Fasting Lipids included: total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and Triglycerides. Fasting Glucose and Lipids were measured in milligrams per deciliter (mg/dL).|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data for lipids and glucose in each treatment group.|||mg/dL||Standard Deviation|Mean
1265824|NCT00392925|Secondary|Number of Participants With BMI Change From Enrollment to Week 20 - Evaluable Population|BMI was measured as kilogram per meter of height squared (kg/m^2). Enrollment was Visit 2 (Week -4). Participants who were obese (BMI of 30 kg/m^2 to <35 kg/m^2) at enrollment were evaluated at Week 20 to see if the same number who were obese at enrollment were still obese at Week 20 or if they had changed to an BMI of overweight (BMI of 25 kg/m^2 to <30 kg/m^2) or a BMI of normal (BMI of <25 kg/m^2) or a greater obesity (BMI >35 kg/m^2). Participants who were overweight (BMI of 25 kg/m^2 to <30 kg/m^2) at enrollment were evaluated at Week 20 to see if the same number who were overweight at enrollment were still overweight at Week 20 or if they had changed to normal (or obese).|Enrollment up to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 20 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 20.|||participants|||Number
1265825|NCT00392925|Secondary|Number of Participants With BMI Change From Enrollment to Week 16 - Evaluable Population|BMI was measured as kilogram per meter of height squared (kg/m^2). Enrollment was Visit 2 (Week -4). Participants who were obese (BMI of 30 kg/m^2 to <35 kg/m^2) at enrollment were evaluated at Week 16 to see if the same number who were obese at enrollment were still obese at Week 16 or if they had changed to an BMI of overweight (BMI of 25 kg/m^2 to <30 kg/m^2) or a BMI of normal (BMI of <25 kg/m^2) or a greater obesity (BMI >35 kg/m^2). Participants who were overweight (BMI of 25 kg/m^2 to <30 kg/m^2) at enrollment were evaluated at Week 16 to see if the same number who were overweight at enrollment were still overweight at Week 16 or if they had changed to normal (or obese).|Enrollment up to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 16.|||participants|||Number
1265826|NCT00392925|Secondary|LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population|Screening (Week -5 or -6) was the first visit for a participant. This first visit determined participant eligibility and occurred prior to enrollment (Week -4). Hip circumference was measured in centimeters (cm).|Screening up to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Those excluded from the Evaluable Population were identified prior to the unblinding process. Number with non-missing anthropometric data in each treatment group were analyzed.|||cm||Standard Error|Least Squares Mean
1265827|NCT00392925|Secondary|LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population|Baseline was Visit 4 (Day 1 of randomization period). Waist circumference was measured in centimeters (cm).|Baseline to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group.|||cm||Standard Error|Least Squares Mean
1265828|NCT00392925|Secondary|LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population|Waist circumference was measured in centimeters (cm). Least Squares mean = LS mean. Enrollment was Visit 2 (Week -4) which was the start of the 4 week Lead-In Period. At Day 1, the participant was randomized to one of the 3 study arms and the participant was treated up to Week 20.|Enrollment to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group.|||cm||Standard Error|Least Squares Mean
1265829|NCT00392925|Secondary|LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population|Excess body weight: the difference between a participant’s actual body weight and the weight a participant of his/her height would have if his/her BMI were 24.9 kg/m2. Excess body weight at a given visit was calculated as body weight in kilograms (kg) at that visit minus 24.9 × height in meters (m)^2 or 0, whichever was greater. If a participant achieved a normal BMI (24.9 kg/m^2), that subject was considered to have no excess weight. Additional weight loss that occurred after a normal BMI was achieved was not included in the calculation of excess weight loss. Enrollment was Visit 2 (Week -4), the start of the Lead-In Period. Baseline was Day 1 of the randomization to a study arm.|Enrollment to Baseline|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. Number with non-missing body weight data at Day 1 of Randomization were analyzed.|||percentage of change||Standard Error|Least Squares Mean
1265830|NCT00392925|Secondary|Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population|Baseline refers to Visit 4 (Day 1 of randomization period). Number of participants with 5% or more and 10% or more change in weight from baseline at each visit. Number of participants with 5% or more change in weight that was sustained through Week 16. Number of participants with 10% or more change in weight that was sustained through Week 20.|Baseline to Weeks 16 and Weeks 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||participants|||Number
1265831|NCT00392925|Secondary|Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population|Initial (Day 1 through Week 12), late (Week 12 through Week 20), and overall (Day 1 through Week 20) rates of Least squares (LS) mean absolute change in body weight were defined by the slopes of the regression lines fitted to the observed body weights during the periods from Baseline (Day 1) through each visit to Week 20. Initial, late and overall absolute change was measured in kilograms of body weight per week (kg/week). Baseline refers to Visit 4 (Day 1 of randomization period).|Baseline to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process.|||kg/week||Standard Error|Least Squares Mean
1265832|NCT00392925|Secondary|LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean percent change is percentage that body weight changed over time at each visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and treated up to Week 20.|Enrollment to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||percentage of change||Standard Error|Least Squares Mean
1265833|NCT00392925|Secondary|LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean change in body weight as measured in kilograms (kg) from enrollment to each study visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and the participant was treated as per that arm up to Week 20.|Enrollment to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||kg||Standard Error|Least Squares Mean
1265834|NCT00392925|Secondary|LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population|Least Squares (LS) mean absolute change in body weight as measured in kilograms (kg) from baseline to Weeks 4, 8, 12, 20. Baseline defined as Day 1 of randomized treatment|Baseline to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||kg||Standard Error|Least Squares Mean
1265835|NCT00392925|Secondary|LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean percent change in body weight from baseline to Weeks 4 through 20. Baseline defined as Day 1 of randomized treatment.|Baseline up to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||percentage of change||Standard Error|Least Squares Mean
1265836|NCT00392925|Primary|Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population|Absolute change in body weight as measured in kilograms (kg) from baseline to Week 16. Baseline defined as Day 1 of randomized treatment.|Baseline to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Participants excluded from the Evaluable Population were identified prior to the unblinding process. n=number with non-missing body weight data at Week 16 in each treatment group.|||kg||Standard Error|Least Squares Mean
1265837|NCT00392860|Primary|Change in Functional Status Score|The Functional Status Scale, which measures hand and wrist symptoms.|Baseline, 4 Months|Zero participants were analyzed because only 4 participants were enrolled in this trial. Analyzing the results would not result in any meaningful information. The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.||||||
1265838|NCT00392834|Secondary|Correlation of EBV Load Measurements With OS, FFS, and EFS||baseline through 2 years post-treatment|||||||
1265839|NCT00392834|Secondary|Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS||baseline through 2 years post-treatment|||||||
1265840|NCT00392834|Secondary|Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results||baseline|||||||
1265841|NCT00392834|Secondary|Utility of Flow Cytometry in Detecting Leptomeningeal Disease||baseline and 6-8 weeks post-treatment|||||||
1265842|NCT00392834|Secondary|Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS||baseline through 2 years post-treatment|||||||
1265843|NCT00392834|Secondary|Incidence of Infection-related Deaths||baseline through 2 years post-treatment|||||||
1265844|NCT00392834|Secondary|Toxicity||baseline through 2 years post-treatment|||||||
1265845|NCT00392834|Secondary|Event-free Survival (EFS)||6-8 weeks post treatment, every 4 months post-treatment for 2 years|||||||
1265846|NCT00392834|Secondary|Failure-free Survival (FFS)||6-8 weeks post treatment, every 4 months post-treatment for 2 years|||||||
1265847|NCT00392834|Secondary|Complete Response Rate||6-8 weeks post treatment, every 4 months post-treatment for 2 years|||||||
1265856|NCT00392782|Secondary|Incidence of Chronic Graft-versus-host Disease (GVHD)|"Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD."|1 Year||||Participants|||Number
1265857|NCT00392782|Secondary|Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)|"Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening."|Day 100||||Participants|||Number
1265858|NCT00392782|Secondary|Incidence of Disease Relapse|Number of patients with disease at 1 year.|1 Year||||Participants|||Number
1265859|NCT00392782|Primary|Incidence of Disease-free Survival|Number of patients alive and without disease at 1 year after transplant.|1 Year||||Participants|||Number
1265860|NCT00392769|Primary|Overall Disease Control Rate|Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.|Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.|There were ten inevaluable participants (completing less than 1 cycle).|||percentage of participants|||Number
1265861|NCT00392704|Secondary|Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment|The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment|24 Months||||percentage of patients|||Number
1265862|NCT00392704|Primary|Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment|The percentage of patients estimated to be alive 2 years after beginning protocol treatment|24 months|All participants in this study were assessed and included in the progression free survival analysis|||percentage of participants|||Number
1265863|NCT00392678|Secondary|Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index|HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in C-peptide from Baseline to Week 14 is in the data table below|Baseline, week 14||||C-peptide in nmol/l||95% Confidence Interval|Mean
1265864|NCT00392678|Secondary|Safety and Tolerability of Salsalate Compared to Placebo as Assessed by Adverse Events.|See adverse event module for details.|14 weeks||||participants|||Number
1265865|NCT00392678|Secondary|Response Rates for a Reduction in HbA1c for Obese vs Non-obese Participants|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14-26 week|||||||
1265866|NCT00392678|Secondary|Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14-26 week|||||||
1265867|NCT00392678|Secondary|Need for Discontinuation of Study Medication|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14 week|||||||
1265868|NCT00392678|Secondary|Need for Rescue Therapy|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14 weeks|||||||
1265869|NCT00392678|Secondary|Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups|Please see adverse events module for hyperglycemia.|14 week|||||||
1265870|NCT00392678|Secondary|Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index|HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in insulin from Baseline to Week 14 in data table below.|Baseline, week 14||||pmol/l||Inter-Quartile Range|Median
1265871|NCT00392678|Secondary|Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio)|LDL-C/HDL-C ratio not calculated|14 week||||mg/dl||95% Confidence Interval|Mean
1265872|NCT00392678|Secondary|Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%|This was an aim proposed for the longer duration study and is reported under TINSAL-T2D stage 2.|14-26 week|||||||
1265873|NCT00392678|Secondary|Change From Baseline and Trends in Fasting Glucose Over Time||14 week||||mg/dl||95% Confidence Interval|Mean
1265874|NCT00392678|Secondary|Change From Baseline to Either 14 or 26 Weeks, or Last HbA1c Measurement Prior to Rescue Therapy|see primary outcome|14 week||||% HbA1c||95% Confidence Interval|Mean
1265875|NCT00392678|Primary|The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 14 (Stage 1) in the Intent-to-treat (ITT) Population With Last Observation Carried Forward.||14 week||||% (units of HbA1c)||95% Confidence Interval|Mean
1265876|NCT00392665|Secondary|Number of Participants With Toxicities According to Severity|Toxicities by Grades 1 or 2 and Grades 3 or 4 in each arm. Grade 4 = life-threatening, Grade 3 = serious, Grade 2 = moderate, Grade 1 = Mild|2 years||||Participants|||Count of Participants
1265877|NCT00392665|Secondary|Duration of Overall Survival|Median overall survival (OS), determined by the Kaplan-Meier method.|2 years||||months||95% Confidence Interval|Median
1265878|NCT00392665|Secondary|Overall Response Rate (ORR)|"Overall response rate (complete plus partial response=ORR), as determined by RECIST.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|Two of eighteen patients in both arms had radiographic partial responses, for an overall response rate of 11% for both arms, (95% CI 1.2%, 34.7%). The identical results below are not typos or placeholder values.|||percentage of participants||95% Confidence Interval|Number
1266513|NCT00386360|Secondary|Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1265879|NCT00392665|Primary|Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.|The primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|1 year||||months||95% Confidence Interval|Median
1265880|NCT00392496|Primary|Objective Tumor Response|It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin’s lymphoma and reviewed independently|Up to 3 years|patients evaluable for response|||participants|||Number
1265881|NCT00392444|Primary|Objective Response (Partial and Complete) Per RECIST|Number of patients who had objective responses after radiology review|Up to 3 years|1 cancelled patient and 4 ineligible patients were excluded from analysis.|||participants|||Number
1265882|NCT00392392|Primary|Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery|Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).|18 months|Two patients refused surgery after completing six cycles of pre-operative (neoadjuvant) therapy.|||percentage of participants|||Number
1265883|NCT00392379|Secondary|Prolonged Smokeless Tobacco Abstinence at 6 Months|Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).|6 months||||Participants|||Number
1265884|NCT00392379|Secondary|Self-reported Point Prevalence All Tobacco Abstinence at 3 Months|Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.|3 months||||Participants|||Number
1265885|NCT00392379|Primary|Prolonged Smokeless Tobacco Abstinence at 3 Months|Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.|3 months|ITT|||Participants|||Number
1265886|NCT00392288|Secondary|Change From Baseline in Use of Albuterol/Salbutamol at Week 12.|Change in albuterol/salbutamol use from baseline to week 12|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.|||Puffs per day||Standard Error|Least Squares Mean
1265887|NCT00392288|Secondary|Change From Baseline in Total Daily Asthma Symptom Score at Week 12.|Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.|||Scores on a scale||Standard Error|Least Squares Mean
1265888|NCT00392288|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.|Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber.|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. The primary analysis was restricted to an age range between 6 and <12 years.|||Percent of predicted FEV1||Standard Error|Least Squares Mean
1265889|NCT00392236|Primary|Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS)|Estimated percent of prescribed medication taken during month 6 of the study was calculated using all available data sources (MEMS supplemented by subject interview and pill counts).|Measured at Month 6||||percentage of prescribed medication take||Standard Deviation|Mean
1265890|NCT00392223|Secondary|Change From Baseline in Acne Graded by Leeds Technique|Leeds Grading technique: evaluates three sites (face, back, chest) on a 0 to 10 grading scale where 0 equals to no acne and 10 equals to most severe acne.|Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).|||score on scale||95% Confidence Interval|Mean
1265891|NCT00392223|Primary|Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.|Baseline, Week 8 EOT|Per Protocol population|||score on scale||95% Confidence Interval|Least Squares Mean
1265892|NCT00392223|Secondary|Improvement of Global Acne Grading System (GAGS) Score|Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score >75% (pre-post evaluation); Good improvement = reduction score > 50 – 75%; Moderate improvement : reduction score > 25 – 50%; Light improvement : reduction score > 0 – 25%; No change = reduction score = 0%; Worsening = increase score > 0 %.|Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.|||participants|||Number
1265893|NCT00392223|Post-Hoc|Number of Subjects With Mild, Moderate, and Severe Acne|Global Acne Grading System score used to assess 6 locations on face/chest/upper back; factor for each based on area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on sum of local scores and se verity: 0=no acne, 1-18=mild, 19-30=moderate, 31-38=severe, >39=very severe.|Baseline, Week 8 End of Treatment (EOT)|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.|||participants|||Number
1265894|NCT00392223|Secondary|Change From Baseline in Global Acne Grading System (GAGS) Score|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline.|Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).|||score on scale||95% Confidence Interval|Mean
1265895|NCT00392223|Primary|Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.|Baseline, Week 8 End of Treatment (EOT)|Full Analysis Set, Last Observation Carried Forward (LOCF)|||score on scale||95% Confidence Interval|Least Squares Mean
1265896|NCT00392210|Primary|Number of Participants Who Passed Bladder Trial|Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).|postoperatively after surgery on day1 or 2||||participants|||Number
1265897|NCT00392197|Secondary|HbA1c|The number of subjects with an HbA1c value of 6.5% or higher were calculated. In addition, for 5.8% and above, the number of subjects were also calculated, in the same way|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation||||participants|||Number
1265898|NCT00392197|Primary|Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)|The number of subjects whose FBS level reached or exceeded 126 mg/dL (200 mg/dL, non-FBS level) at least once during the test product administration period as well as the incidence were determined. Also, for 110 mg/dL and above (140 mg/dL, non-FBS level), the number of subjects were determined in the same way.|Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation|Subjects who were treated with at least 1 tablet of the test product, and whose blood glucose level was measured at least once after test product administration were included in the glucose metabolism analysis set. However, subjects who violated inclusion criteria and exclusion criteria were excluded.|||participants|||Number
1265899|NCT00392171|Primary|Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.|Progression-free survival as determined by Kaplan-Meier method.|6 months|"Participants who received allocated intervention.~The percentage of participants reported is based on the number of participants within each category (not total number of all categories combined)."|||Percentage of Participants|||Number
1265900|NCT00391989|Secondary|OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.||End of study|||||||
1265901|NCT00391989|Secondary|the Cumulative Incidence of Relapse;||End of study|||||||
1265902|NCT00391989|Secondary|DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;||End of study|||||||
1265903|NCT00391989|Secondary|the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;||End of study|||||||
1265904|NCT00391989|Secondary|The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;||End of study|||||||
1265905|NCT00391989|Secondary|The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;||End of study|||||||
1265906|NCT00391989|Primary|Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).||End of the study, up to day 85||||Patients|||Number
1265907|NCT00391976|Secondary|Number of Participants Hospitalized for Pulmonary Exacerbations|Core study defined as from Baseline through to one month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group). Follow-up phase began at the end of the core study through to the end of the study (Month 27).|From Baseline to end of study (27 months)|All patients who were randomized and received at least one dose of study medication. Non-randomized patients were not included in the analysis.|||Participants|||Number
1265908|NCT00391976|Secondary|Percentage of Patients With Pseudomonas (P.) Aeruginosa Having an Increased, Decreased, or Unchanged Tobramycin Minimum Inhibitory Concentration (MIC) Value at the Final Visit Compared to Baseline|The percentage of patients with changes in tobramycin MIC values from Baseline to the final visit could not be compared as there was insufficient data.|From Baseline to the final visit (end of the study, Month 27)|Safety population: All patients who were enrolled in the study and received at least 1 dose of study medication.|||Percentage of participants|||Number
1265909|NCT00391976|Secondary|Time to Recurrence of Pseudomonas (P.) Aeruginosa (New or Same Genotype) in Sputum or Deep Throat Cough Swab Based on Confirmatory Assessment by the Central Laboratory|Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.|From 1 month after the end of treatment until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.|||Months||95% Confidence Interval|Median
1265910|NCT00391976|Secondary|Percentage of Patients With Pseudomonas (P.) Aeruginosa Eradicated From Deep Throat Cough Swab or Sputum|One month after the end of treatment was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.|From 1 month after the end of treatment until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.|||Percentage of participants|||Number
1265922|NCT00391872|Secondary|Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding|Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.|First dosing up to 12 months|Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.|||Participants|||Number
1296440|NCT00068718|Secondary|Incidence of Infections in Patients Undergoing DLI Following a Non-myeloablative Transplant|Percentage of Participants with infections.|100 days after DLI||||percentage of participants|||Number
1265911|NCT00391976|Primary|Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab|Microbiological samples were obtained from sputum or by deep throat cough swab technique. Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group. Kaplan-Meier estimates were used.|From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.|||Months||95% Confidence Interval|Median
1265912|NCT00391898|Secondary|Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3|The QQ is a self-administered questionnaire that includes 19 wearing-off (WO) symptoms (motor and non-motor). A positive answer to each of the 19 symptoms is given by patients if they presented with a symptom and the symptom disappeared after the next drug dose. Two positive answers are diagnostic of wearing-off (WO). A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Positive answers||Standard Deviation|Mean
1265913|NCT00391898|Secondary|Patient and Investigator Global Evaluation of the Patient|Both the patient and the investigator made an evaluation of the change in the patient’s condition by rating the condition of the patient at the end of the study compared to patient’s condition at baseline. The rating was made on a scale ranging from -3 to +3: (-3: Very much improved, -2: much improved, -1: mild improvement, 0: no change, +1: mild deterioration, +2: much deterioration, +3: very much deterioration). A negative score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
1265914|NCT00391898|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3|The PDQ-39 is an instrument used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognitions, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 195. A lower score indicates better quality of life. A positive change score indicates an improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
1265915|NCT00391898|Secondary|Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3|Part IV of the UPDRS measures complications the patient may be experiencing with therapy and was only collected at and after the visit at which the first dyskinesia or episode of wearing-off was recorded. Part IV is composed of 3 sections and 11 items: A (32-35, dyskinesia), B (36-39, clinical fluctuations, C (40-42, other complications) (total score 0-23, calculated as the sum of the individual items). A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
1265916|NCT00391898|Secondary|Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part III (items 18-31; total score 0-56, calculated as the sum of the individual items) measures the patient’s motor function. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
1265917|NCT00391898|Secondary|Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part I (items 1-4; total score 0-16, calculated as the sum of the individual items) measures the patient’s mentation, mood and behavior. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
1265918|NCT00391898|Primary|Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with the last observation carried forward (LOCF)|||Units on a scale||Standard Deviation|Mean
1265919|NCT00391872|Secondary|Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization|Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.|1-week period following randomization|Patients who were monitored for one week following randomization (and for one week one month later).|||Participants|||Number
1265920|NCT00391872|Secondary|Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization|Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.|1-week period following randomization|Participants with Holter data in the week after Randomization|||Participants|||Number
1265921|NCT00391872|Secondary|Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding|Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.|First dosing up to 12 months|Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.|||Participants|||Number
1265923|NCT00391872|Secondary|Participants With Non-procedural Major Bleeding|Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug|||Participants|||Number
1265924|NCT00391872|Secondary|Participants With Major or Minor Bleeding|Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug|||Participants|||Number
1265925|NCT00391872|Secondary|Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding|Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug|||Participants|||Number
1265926|NCT00391872|Secondary|Participants With Death From Any Cause|Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
1265927|NCT00391872|Secondary|Participants With Stroke|Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
1265928|NCT00391872|Secondary|Participants With Death From Vascular Causes|Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
1265929|NCT00391872|Secondary|Participants With MI Event|Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
1265930|NCT00391872|Secondary|Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.|Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
1265931|NCT00391872|Secondary|Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke|Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
1265932|NCT00391872|Secondary|Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization|Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The subgroup of patients with intent for invasive management at randomization|||Participants|||Number
1265933|NCT00391872|Primary|Participants With Any Major Bleeding Event|Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug|||Participants|||Number
1265934|NCT00391872|Primary|Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke|Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
1265935|NCT00391846|Secondary|Discontinuations|Number of patients discontinued due to adverse events’|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Participants|||Number
1265936|NCT00391846|Secondary|Total Number of Titration Steps in Prescribed Heart Failure Treatment|Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Titration steps|||Number
1265937|NCT00391846|Secondary|Changes in Health-related Quality of Life|Change range –100 to 100. The higher the better.|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||KCCQ overall score||Standard Error|Mean
1265938|NCT00391846|Secondary|Changes in NT-proBNP Values Over Time in All Patients|The 95% confidential interval (CI) is given as measure of dispersion|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||ng/L||95% Confidence Interval|Geometric Mean
1265939|NCT00391846|Secondary|Changes in Heart Failure Symptoms|Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Categorial scale||Standard Deviation|Mean
1265940|NCT00391846|Secondary|Number of Days in Hospital for CV Reason|Each overnight stay is counted as one day. The lower the better|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Days in hospital||Standard Deviation|Mean
1265941|NCT00391846|Secondary|Number of CV Deaths|Number of deaths|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Participants|||Number
1265942|NCT00391846|Primary|Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)|The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Scores on a scale||Standard Deviation|Mean
1265943|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population|||Percentage of Participants|||Number
1265944|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population|||Percentage of Participants|||Number
1265945|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population|||Percentage of Participants|||Number
1265946|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population|||Days||Standard Deviation|Mean
1265947|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population|||Days||Standard Deviation|Mean
1265948|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population|||Days||Standard Deviation|Mean
1265949|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population||12 cycles, 28 days each (336 days)|MITT Population|||Days||Standard Deviation|Median
1265950|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population|||Days||Standard Deviation|Median
1265951|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population|||Days||Standard Deviation|Median
1265952|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population|||Percentage of Participants|||Number
1265953|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population|||Percentage of Participants|||Number
1265954|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population|||Percentage of Participants|||Number
1265955|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population|MITT Population|13 cycles, 28 days each (1 year)|MITT Population|||Bleeding/Spotting Days||Standard Deviation|Mean
1265956|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population|MITT Population|6 cycles, 28 days each (168 days)|MITT Population|||Bleeding/Spotting Days||Standard Deviation|Mean
1265957|NCT00391807|Primary|Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population||13 Cycles, 28 days each (1 year)|MITT Population, All Subjects 18-45 years old, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population|||Pregnancy Rate|Participants||Number
1265958|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population|MITT Population|2 Cycles, 28 days each (56 days)|MITT Population|||Bleeding/Spotting Days||Standard Deviation|Mean
1265959|NCT00391807|Primary|Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,||13 cycles, 28 days each (1 year)|Modified Intent to Treat Population (MITT), Women Aged 18-35, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population|||Pregnancy Rate|Participants||Number
1265976|NCT00391625|Primary|Evaluation of Long Term Safety|Overall Summary of Treatment-emergent Adverse Events-Safety Population|Up to 84 months|ITT patient population|||Participants|||Number
1265977|NCT00391599|Primary|Number of Participants Had Spontaneous Feces|occurrence of spontaneous feces|On postoperative day 1||||participants|||Number
1265978|NCT00391599|Primary|Number of Participants With Gas Passage|gas passage: present|On postoperative day 1||||participants|||Number
1265960|NCT00391768|Secondary|Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort.|The Spearman coefficient and the p-values were computed between the clearance of viral RNA and oseltamivir carboxylate Area Under the Curve from 0 to 12 hours (AUC 0-12)|From date of enrollment until the date of first documented absence of viral load by culture, assessed up to 10 days after enrollment.|Subjects included in this analysis are those who had viral loads at baseline (day 0) and had a non-detectable viral load on one of the following study visit days: day 3, day 5, or day 10. Virus was obtained from a nasal swab. Subjects also would have had evaluable PK samples on study day 3.|||correlation measure|||Number
1265961|NCT00391768|Secondary|Correlation of Clearance of Viral RNA by Culture With Pharmacokinetic Parameters by Cohort|The Spearman coefficient and the p-values were computed between the clearance of Viral RNA and Oseltamivir Carboxylate Area under the curve from 0 to 12 hours (AUC0-12)|Day to negative viral load for subjects positive at baseline|Subjects included in this analysis are those who had positive culture at baseline (day 0) and had a negative culture on one of the following study visit days: Day 3, Day 5 or Day 10. Culture was obtained from a a nasal swab. Subjects also would have had evaluable PK samples on study day 3.|||Spearman coefficient|||Number
1265962|NCT00391768|Secondary|Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)|Serious Adverse Event (SAE) were classified by MedDRA System Organ Class (SOC). An SAE was reported if it met the following criteria and occurred after the first dose of study medication through the end of the study: death throughout study participation; life threatening; requires inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance; results in congenital anomaly or birth defect; results in a persistent or significant disability; and an event considered serious by the PI.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days||||Participants|||Number
1265963|NCT00391768|Secondary|Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort Leading to Discontinuation of Study Medication|Study drug was administered for 5 days; any event that occurred prior to the last dose of study medication that was considered related to an AE and that caused the subject to stop taking study drug.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 5 plus or minus 1 day||||events|||Number
1265964|NCT00391768|Secondary|Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade|Any event considered to be related to the study drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately. The Division of AIDS Toxicity Tables (DIAIDS) were used to grade the events.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days|Intention to treat (ITT)|||Participants|||Number
1265965|NCT00391768|Secondary|Number and Characteristics of Adverse Events (AEs) Described as Neurological Events.|Any neurological event that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.|Intention to treat (ITT)|||participants|||Number
1265966|NCT00391768|Secondary|Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy.|Any event considered associated with drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.|Intention to treat (ITT)|||participants|||Number
1265967|NCT00391768|Primary|Oseltamivir Carboxylate AUC12 (Area Under the Curve).|The oseltamivir carboxylate AUC12 was derived from a series of five blood draws over 10 to 12 hours.|Day 3 of drug administration|Subjects that received 3 days study drug administration and had successful PK draws on study day 3.|||participants|||Number
1265968|NCT00391716|Secondary|Craving|Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.|12-week||||units on a scale||Standard Error|Mean
1265969|NCT00391716|Secondary|Sleep|The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.|12-week||||units on a scale||Standard Error|Mean
1265970|NCT00391716|Secondary|Mood|Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.|12-week||||units on a scale||Standard Error|Mean
1265971|NCT00391716|Primary|Drinking|Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).|12-week|All randomized subjects included in denominator for rate determination.|||participants|||Number
1265972|NCT00391625|Secondary|Percent Change From Baseline in Spleen Size||Baseline, Month 24, then every 9 or 12 months|ITT (One patient was excluded due to an intravascular metallic device that prevented accurate spleen evaluation.)|||Percent Change from Baseline||Standard Error|Mean
1265973|NCT00391625|Secondary|Percent Change From Baseline in Liver Volume||Baseline, Month 24, then every 9 or 12 months|ITT|||Percent Change from Baseline||Standard Error|Mean
1265974|NCT00391625|Secondary|Percent Change From Baseline in Platelet Counts||Baseline, then every 12 months|ITT patient population|||Percent Change from Baseline||Standard Error|Mean
1265975|NCT00391625|Secondary|Percent Change From Baseline in Hemoglobin Concentration||Baseline, then every 12 months|Intent to treat (ITT) patient population|||Percent Change from Baseline||Standard Error|Mean
1265980|NCT00391586|Primary|Toxicity Profile|Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.|28 days after last on-study treatment||||participants|||Number
1265981|NCT00391586|Primary|Progression-free Survival (PFS)||5 years|This study was terminated early; no results are available. The number of patients who completed treatment and therefore the number of evaluable patients was too low to accurately calculate endpoints.||||||
1265982|NCT00391469|Secondary|Neurologic Status at Discharge-full Recovery||at time of discharge||||participants|||Number
1265983|NCT00391469|Primary|Number Alive at Hospital Discharge||at hospital discharge||||participants|||Number
1265984|NCT00391443|Secondary|Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.|Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).|12 months|ITT population|||percentage of participants with event||95% Confidence Interval|Number
1265985|NCT00391443|Primary|Time to Occurrence of Disease Worsening or Death up to End of Study.|Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).|36 months|The primary analysis was performed on the Intent To Treat (ITT) population.|||participants with event|||Number
1265986|NCT00391391|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds|Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 to Day 7 post-vaccination|Safety parameters were determined post-vaccination in the safety, intend-to-treat population.|||Participants|||Number
1265987|NCT00391391|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.|Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.|Day 0 to Day 7 post-vaccination|Safety parameters were determined post-vaccination in the safety, intend-to-treat population.|||Participants|||Number
1265988|NCT00391391|Secondary|Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.|Day 28 post-vaccination|Seroconversion to vaccine antigens were determined in the per-protocol population|||Percentage of Participants|||Number
1265989|NCT00391391|Secondary|Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|"Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.~Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique."|Day 28 post-vaccination|Seroprotection to vaccine antigens were determined in the per-protocol population|||Percentage of Participants|||Number
1265990|NCT00391391|Secondary|Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.|Day 28 post-vaccination|4-Fold Rise in Serum HAI Antibody Titers were determined in the per-protocol population|||Percentage of Participants|||Number
1265991|NCT00391391|Primary|Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.|Day 0 and Day 28 post-vaccination|Geometric Mean Titers were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1265992|NCT00391365|Secondary|Bodily Pain Section of Short Form-36 (SF-36)|"Patient reported bodily pain data from the SF-36, a thirty-six item survey evolved from the RAND 36.~Number shows change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.)"|Over the course of 3 years.|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 bodily pain data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.|||units on a scale||Standard Error|Mean
1265993|NCT00391365|Secondary|Physical Function Section of Short Form-36 (SF-36)|"Patient reported physical function data from the SF-36, a thirty-six item survey evolved from the RAND 36.~Change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.)"|Over the course of 3 years.|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 physical function data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.|||units on a scale||Standard Error|Mean
1265994|NCT00391365|Primary|Musculoskeletal Functional Assessment (MFA)|"Patient reported data using the MFA, a general functional assessment intended as a tool for evaluation of patients' perceptions of their physical, psychological, and social well-being that asks patients to assess their function on 100 items.~Number shows change in outcome from pre-op to 3 years by surgery type, with a lower score implying an improved outcome (scale range 0 -100.)"|Over the course of 3 years|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the MFA data collected from 99 arthrodesis subjects, and 165 arthroplasty subjects.|||units on a scale||Standard Error|Mean
1266296|NCT00389064|Secondary|Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score|HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
1265995|NCT00391274|Post-Hoc|Number of Patients With Disease Progression|Number of patients who have died or have had progression of disease. This outcome substitutes for the outcome on Duration of Response.|time of response to progressive disease (up to 12 months)|Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Patients censored: pemetrexed=6, docetaxel=3.|||participants|||Number
1265996|NCT00391274|Primary|Overall Survival|Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.|baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)|Intent to treat population. Number of patients censored (up to 24 months): pemetrexed = 51, docetaxel = 55. Number of participants censored (up to 30 months): pemetrexed = 30, docetaxel = 32.|||months||95% Confidence Interval|Median
1265997|NCT00391274|Secondary|Pharmacology Toxicity|Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.|first dose of study drug up to 24 months|Patients who received at least one dose of study drug.|||participants|||Number
1265998|NCT00391274|Secondary|Duration of Response|"Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as Number of Patients with Disease Progression."|time of response to progressive disease (up to 24 months)|Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Results not presented because median was not calculable for the docetaxel arm.|||months||95% Confidence Interval|Median
1265999|NCT00391274|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.|baseline to measured progressive disease (up to 24 months after study enrollment)|"Intent to treat population. Patient censored:~pemetrexed=25, docetaxel=39."|||months||95% Confidence Interval|Median
1266000|NCT00391274|Secondary|Overall Tumor Response|"Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria."|baseline to measured tumor response (up to 24 months after study enrollment)|Patients who received at least one dose of study drug and qualified for tumor response analysis (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease).|||participants|||Number
1266001|NCT00391222|Secondary|Time to Recurrence of a Mood Episode (Exploratory/Olanzapine)|Recurrence was defined as for the risperidone LAI and placebo arms (meeting any of 5 criteria). Since the study was designed to compare the efficacy of risperidone LAI versus placebo, this olanzapine analysis was exploratory in nature.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 1 patient in the olanzapine arm (discontinued the study due to non-compliance to the study medication).|||days||Standard Error|Mean
1266002|NCT00391222|Secondary|Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS)|The MADRS was assessed by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. The scale consists of 10 items that cover all of the core depressive symptoms. Each item is scored from 0 to 6 and a total score is calculated by adding the scores of all 10 items. For each individual item as well as for the total score, a higher score represents a more severe condition.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||units on a scale||Standard Error|Mean
1266003|NCT00391222|Secondary|Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS)|The 11-item YMRS was administered by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. A severity rating was assigned to each of the items, based on the patient's subjective report of his or her condition over the previous 7 days or since the last visit (whichever was shorter) and the clinician’s behavioral observations during the interview, with emphasis on the latter. The total YMRS score included the score of all 11 items ranging from 0 to 60, a higher score indicating a more severe condition.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||units on a scale||Standard Error|Mean
1266004|NCT00391222|Secondary|Time to Early Study Discontinuation for Any Reason|The robustness of the primary outcome analysis was tested by means of a sensitivity analysis: patients who discontinued the study during Period III for any reason were analyzed as having a recurrence of a mood episode at the time of their study discontinuation. The same survival analysis method as for the primary outcome was applied.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||days||Standard Error|Mean
1266005|NCT00391222|Secondary|Time to Recurrence of a Depressive Episode|Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of a depressive episode was estimated by means of the same survival analysis method as for the primary outcome.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||days||Standard Error|Mean
1266006|NCT00391222|Secondary|Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode|Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of an elevated mood episode was estimated by means of the same survival analysis method as for the primary outcome.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||days||Standard Error|Mean
1266007|NCT00391222|Primary|Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo)|Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) >12 or Montgomery-Åsberg Depression Rating Scale (MADRS) >12 combined with Clinical Global Impression – Severity (CGI-S) >=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||days||Standard Error|Mean
1266008|NCT00391092|Secondary|Change From Baseline for FACT-G and FACT-B|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.|Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])|ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.|||units on a scale||Standard Deviation|Mean
1266009|NCT00391092|Secondary|Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.|Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])|ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.|||units on a scale||Standard Deviation|Mean
1266010|NCT00391092|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population|||months||95% Confidence Interval|Median
1266011|NCT00391092|Secondary|Duration of Response (DR)|DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population: only participants with a best OR of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
1266012|NCT00391092|Secondary|Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline|Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population; only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1266013|NCT00391092|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population|||months||95% Confidence Interval|Median
1266014|NCT00391092|Primary|Progression Free Survival (PFS)|PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators’ assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population|||months||95% Confidence Interval|Median
1266015|NCT00391079|Secondary|Change in Sleep Disruption NRS|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|14 weeks; Baseline to end of treatment (last 7 days)||||points on a scale||Standard Deviation|Mean
1266016|NCT00391079|Secondary|Change in Subject Global Impression of Change (SGIC)|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At baseline subjects wrote a brief description of their pain caused by multiple sclerosis which was used at Week 14 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Week 14|All subjects who completed the question were included in the analysis. Two subjects from the Sativex group and six subjects from the placebo group did not complete the question.|||percentage of subjects|||Number
1266017|NCT00391079|Secondary|Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|14 weeks: Baseline to end of treatment (last 7 days of treatment)|All subjects who completed the BPI-short form were included in the analysis. Four subjects from the sativex group and three subjects from the placebo group did not complete the form.|||Points on a scale||Standard Deviation|Mean
1266018|NCT00391079|Secondary|Change From Baseline to End of Treatment in Break-through Analgesia Usage|Use of break through medication was recorded daily during the 14 weeks of the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|14 weeks: baseline - end of treatment (last 7 days)||||tablets||Standard Deviation|Mean
1266019|NCT00391079|Secondary|Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|14 weeks: Baseline - End of treatment (Week 14)||||Points on a scale||Standard Deviation|Mean
1266020|NCT00391079|Primary|Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. The pain NRS was completed at the same time each day, i.e. bedtime in the evening."|14 weeks: Baseline - end of treatment (last 7 days)||||participants|||Number
1266021|NCT00391079|Primary|Change in Mean Pain Due to MS NRS Score|"The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. A negative value indicates an improvement in pain score from baseline."|14 weeks: Baseline - End of Treatment (last 7 days of treatment)|Change in mean daily NRS score|||units on a scale||Standard Deviation|Mean
1266022|NCT00391053|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination|The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.|Day 0 to Day 7 Post-vaccination|The safety analysis was performed on the Full Analysis Set according to the participants who actually received a vaccine, whether or not the subject received the assigned vaccine. A total of 3,833 participants were included in the analysis set for the evaluation of all safety.|||Percentage of Participants|||Number
1266023|NCT00391053|Secondary|Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.|Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.|Day 0 and Day 28 Post-vaccination|The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.|||Percentage of Participants|||Number
1266024|NCT00391053|Primary|Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.|Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).|Day 28 Post-vaccination|The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.|||Percentage of Participants|||Number
1266025|NCT00391053|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.|Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.|Day 0 and Day 28 Post-vaccination|The geometric mean titers was assessed in the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.|||Titers||95% Confidence Interval|Geometric Mean
1266026|NCT00391027|Secondary|Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects|Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program.|Baseline, Week 26|||||||
1266027|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)|Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.|Baseline, Week 26|FAS; LOCF.|||pg/ml||Standard Deviation|Mean
1266028|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)|Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.|Baseline, Week 26|FAS; LOCF.|||ng/ml||Standard Deviation|Mean
1266029|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)|Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.|Baseline, Week 26|FAS; LOCF.|||pg/ml||Standard Deviation|Mean
1266030|NCT00391027|Secondary|Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)|Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.|Baseline, Week 26|FAS; LOCF.|||mg/dl||Standard Deviation|Mean
1266031|NCT00391027|Secondary|Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients|The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.|Baseline, Week 26|FAS; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively. Revised table rectifies a programming code error that was determined post-Clinical study report (CSR) approval.|||mg/dl||Standard Deviation|Mean
1266032|NCT00391027|Secondary|Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health|Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program.|Week 26|||||||
1266033|NCT00391027|Secondary|Number of Subjects Discontinued Due to Insufficient Clinical Response|Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12.|Week 26|Safety population: all subjects who received at least 1 dose of study medication.|||participants|||Number
1266034|NCT00391027|Secondary|Change From Baseline in Body Mass Index (BMI)|BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.|Baseline, Week 26|FAS; LOCF.|||kg/m2||Standard Deviation|Mean
1266035|NCT00391027|Secondary|Change From Baseline in Body Weight|Change from baseline calculated as body weight at observation minus body weight at baseline.|Baseline, Week 26|FAS; LOCF.|||kilograms (kg)||Standard Deviation|Mean
1266036|NCT00391027|Secondary|Number of Events of Nocturnal Hypoglycemia|Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.|Week 26|FAS|||events|||Number
1266037|NCT00391027|Secondary|Number of Subjects With Hypoglycemic Events by Severity|Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.|Week 26|FAS|||participants|||Number
1266038|NCT00391027|Secondary|Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)|Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.|Baseline, Week 26|FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.|||mg/dl||Standard Deviation|Mean
1266039|NCT00391027|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level|FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.|Baseline, Week 26|FAS; LOCF.|||mg/dl||Standard Deviation|Mean
1266040|NCT00391027|Secondary|Number of Subjects With HbA1c < 8.0 %|Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.|Week 26|FAS|||participants|||Number
1266041|NCT00391027|Secondary|Number of Subjects With HbA1c < 7.0 %|Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.|Week 26|FAS|||participants|||Number
1266042|NCT00391027|Secondary|Number of Subjects With HbA1c < 6.5 %|Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.|Week 26|FAS|||participants|||Number
1266043|NCT00391027|Secondary|Change From Baseline in HbA1c Prior to Week 26|Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18|FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.|||percent||Standard Deviation|Mean
1266044|NCT00391027|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.|Baseline, Week 26|Full analysis set (FAS) all randomized subjects with at least 1 dose of study medication, baseline and post-baseline HbA1c measurement. Last observation carried forward (LOCF).|||percent||Standard Deviation|Mean
1266045|NCT00390910|Secondary|Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Vaccine response to PT, FHA and PRN was defined as appearance of antibodies in subjects who are initially seronegative (S-), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+). For the SYNFLORIX™ + INFANRIX™ HEXA GROUP I, no subjects presented initial seropositivity for PT and PRN antigens.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266046|NCT00390910|Secondary|Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off|Seroprotection status was defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1266047|NCT00390910|Secondary|Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres|The cut-off for the assay was ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266048|NCT00390910|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Seroprotection status was defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1266049|NCT00390910|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off.|The cut-off for the assay was ≥ 10 milli-international units per milliliter (mIU/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266050|NCT00390910|Secondary|Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Seropositivity status was defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1266312|NCT00388726|Secondary|Duration of Response.|As measured by RECIST criteria and defined as the time from the first documented CR or PR until disease progression or death from any cause.|From first documented CR or PR until disease progression or death.|Response Evaluable Population|||Days||Full Range|Median
1266051|NCT00390910|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off|The cut-off for the assay was ≥ 5 ELISA unit per milliliter (EL.U/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266052|NCT00390910|Secondary|Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off|Seroprotection status was defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1266053|NCT00390910|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off|The cut-off for the assay was ≥ 1.0 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266054|NCT00390910|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off|The cut-off for the assay was ≥ 0.15 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266055|NCT00390910|Secondary|Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off|Seroprotection status was defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1266056|NCT00390910|Secondary|Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off|The cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266057|NCT00390910|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Seropositivity status was defined as anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1266058|NCT00390910|Secondary|Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off|The cut-off for the assay was ≥ 100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266059|NCT00390910|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Seropositivity status was defined as opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1266060|NCT00390910|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off|The cut-off for the assay was ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266061|NCT00390910|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1266116|NCT00390780|Secondary|General and Local Tolerability and Oral Discomfort|Overall local adverse reactions, including gingival inflammation, gum pain, alterations in taste of food when eating, alterations in taste when not eating, and dry mouth. Visit 4 occurred on Day 14.|14 days|Safety Population (same as ITT population, includes all randomized patients who took at least one dose of the study medication)|||participants|||Number
1266062|NCT00390910|Secondary|Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off|The cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266063|NCT00390910|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1266064|NCT00390910|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off|The cut-off for the assay was ≥ 8|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266065|NCT00390910|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1266066|NCT00390910|Secondary|Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off|The cut-off for the assay was ≥ 0.05 microgram per mililiter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the ATP cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266067|NCT00390910|Secondary|Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off|The cut-off for the assay was ≥ 0.20 microgram per mililiter (μg/ mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1266068|NCT00390910|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
1266069|NCT00390910|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
1266070|NCT00390910|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
1266081|NCT00390806|Secondary|Number of Participants Who Died or Progressed|Disease-related events were measured as the number of participants who died or progressed. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. Data were analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before an event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|mITT Population|||participants|||Number
1266071|NCT00390910|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
1266072|NCT00390910|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm). “Any” was defined as incidence of the specified symptom regardless of intensity.|Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
1266073|NCT00390910|Primary|Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off|Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.|Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
1266074|NCT00390884|Other Pre-specified|Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®|Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination|Days 0-7 Post-vaccination|The safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
1266075|NCT00390884|Secondary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®|Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.|Day 28 Post-vaccination|The Geometric Mean Titers were analyzed in the per-protocol immunogenicity population|||Titers||95% Confidence Interval|Geometric Mean
1266076|NCT00390884|Primary|Percentage of Seroprotected Participants Post-vaccination With Fluzone®|Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.|Day 28 Post-vaccination|Hemagglutination inhibition titers to the Fluzone® vaccine antigens were assessed in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1266077|NCT00390858|Secondary|Relative Change in Serum Ferritin Level|Serum levels were drawn at the baseline of the Core Study up to 18 months of the Extension Study. Levels were analyzed for serum ferritin measured in micrograms per Liter. Relative change (%) in serum ferritin level was assessed from Baseline to Extension 18 months. Relative Change = 1 - (Change in ferritin level from Baseline/Baseline level) x 100.|Baseline of Core Study to Extension 18 months, up to 2.5 years.|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.|||percent change||Standard Deviation|Mean
1266078|NCT00390858|Secondary|Total Body Iron Elimination (TBIE) Rate (mg/kg/Day)|Total Iron Body Elimination (TBIE) Rate [mg/kg/Day] was calculated for each patient based on SQUID ( Superconducting Quantum Interference Device) results.|Baseline of Core Study to End of Extension Study, up to 5 years|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.|||mg/kg/Day||Standard Deviation|Mean
1266079|NCT00390858|Primary|Change in Liver Iron Concentration (LIC)|Change in Liver Iron Concentration [LIC] measured by means of SQUID (Superconducting Quantum Interference Device). LIC is expressed in milligrams of iron per gram of liver dry weight (mg Fe/g dw)|Baseline of Core Study to End of Extension Study, up to 5 years.|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.|||mg Fe/g dw||Standard Deviation|Mean
1266080|NCT00390858|Primary|Participants With Adverse Events by Primary System Organ Class (SOC)|Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product.|4 year extension + core 1 year|The safety set comprising of all the 40 patients who received at least one dose of deferasirox during the core or extension study was used in all analyses.|||participants|||Number
1266082|NCT00390806|Secondary|Brain Symptoms|"Brain symptoms were assessed as the number of participants with neurological signs and symptoms. For brain symptom data, see the outcome measures entitled Number of participants with the indicated investigator assessment for the neurological sign and symptom of X at Baseline, Month 1, and Month 3."|Baseline, Month 1, and Month 3|||||||
1266083|NCT00390806|Secondary|Lesion Assessment and Measurement|"Lesions were assessed per WHO criteria. For lesion assessment data, see the outcome measure entitled Number of participants with a complete response (CR) or a partial response (PR) (central nervous system [CNS]-radiologic)."|From the time of Randomization until the time of CR or PR (up to 75 weeks)|||||||
1266084|NCT00390806|Secondary|Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range|"The worst-case change from Baseline in chemistry parameters was measured as decrease to low (DTL), change to normal or no change (CTN/NC), or increase to high (ITH). The worst-case change value could have been measured at any point during the on-therapy period. Participants are counted twice if the participant Decreased to Low and Increased to High during the on-therapy period."|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|"Modified ITT Population. Only those participants with available laboratory values (indicated by the n in the category titles) were analyzed. Different participants may have been analyzed for different parameters; therefore, the overall number of participants analyzed reflects everyone in the Modified ITT Population."|||participants|||Number
1266085|NCT00390806|Secondary|Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect. For a list of all SAEs and AEs, see the SAE/AE module of this results summary.|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|Modified ITT Population: all randomized participants who received at least one dose of randomized therapy. Participants were analyzed by the actual treatment received, even if this differed from the treatment to which they were randomized.|||participants|||Number
1266086|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (balance) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266087|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (gait) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266088|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (left upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266089|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (right upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266090|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3|The investigator assessed participants' status of sensation and assigned each participant to one of the following categories: normal; loss of deep tendon reflexes or paresthesia, but not interfering with function (not interfering with function); objective sensory loss or paresthesia interfering with function, but not interfering with ADLs (interfering with function); sensory loss or paresthesia interfering with ADLs (intefering with ADLs); permanent sensory loss that interferes with function (permanent sensory loss).|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266091|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (left lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1271390|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4|Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose|After 4 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1266092|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (right lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266093|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (left upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266094|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (right upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266095|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of language (dysphasia or aphasia) and assigned each participant to one of the following categories: absent; awareness of receptive or expressive aphasia, not impairing ability to communicate (not impaired); receptive or expressive dysphasia, impairing ability to communicate (impaired); inability to communicate (unable).|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266096|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3|The investigator assessed participants' status of cranial nerves II-XII and assigned each participant to one of the following categories: normal; present, not interfering with ADLs; present, interfering with ADLs; life threatening, disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1266097|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for other neurological symptoms and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
1266098|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for seizure and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
1266105|NCT00390806|Secondary|Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3|Neurological signs and symptoms data were derived from a participant-reported diary. The participants were asked to assess the following signs and symptoms on a scale of none, mild, moderate, or severe at Months 1 and 3: headache, problems with balance/coordination (PB/C), leg weakness, arm weakness, loss of feeling/numbness (LofF/N), speech difficulty (SD), confusion, loss of memory (LofM), drowsiness, nausea, vomiting, dizziness, visual problems (VP), seizures, leg/ankle swelling (L/AS), heart burn, difficulty sleeping (DS), tiredness, and appetite/weight gain (A/WG).|Months 1 and 3|ITT Population. Only those participants who were assessed for the indicated sign and symptom at the indicated time point were analyzed.|||participants|||Number
1266099|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for visual problem and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
1266100|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for nausea/vomiting and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
1266101|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for vertigo and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
1266102|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for dizziness/lightheadedness and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
1266103|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3|The investigator (per Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) assessed participants for headache and assigned each participant to one of the following categories: absent, Grade (G) 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
1266104|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3|The investigator assessed participants for the neurological sign and symptom of level of consciousness and assigned each participant to one of the following categories: normal; somnolence or sedation not interfering with function (not intefering); somnolence or sedation interfering with function, but not activities of daily living (ADLs) (interfering); obtundation or stupor, difficult to arouse, inteferring with ADLs (obtundation or stupor); coma.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
1271391|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 16|Mean weekly evening peak expiratory flow at week 16, pre-dose|After 16 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
1266106|NCT00390806|Secondary|Time to Progression (TTP) (All Sites of Disease-radiologic)|TTP is defined as the time from Randomization until the first documented sign of disease progression in all sites of disease. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)|ITT Population|||weeks||95% Confidence Interval|Median
1266107|NCT00390806|Secondary|Time to Progression (TTP) (CNS-radiologic)|TTP is defined as the time from Randomization until the first documented sign of disease progression in the CNS. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)|ITT Population|||weeks||95% Confidence Interval|Median
1266108|NCT00390806|Secondary|Time to Response (TTR) (CNS-radiologic)|TTR is defined as the time from Randomization until the first documented evidence of CR or PR in the CNS. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.|From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)|ITT Population. Only those participants with a CR, PR, or a missing response were assessed. TTR was analyzed with censoring for extended loss to follow-up to account for two or more missed response assessments before a TTR event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|||weeks||95% Confidence Interval|Median
1266109|NCT00390806|Secondary|Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)|The number of participants achieving either a CR or PR, per World Health Organization (WHO) Criteria, in the CNS was assessed. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.|From the time of Randomization until the time of CR or PR (up to 75 weeks)|ITT Population|||participants|||Number
1266110|NCT00390806|Secondary|Six-month Survival|Six-month survival is defined as the percentage of participants alive at 6 months following randomization. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.|Month 6|ITT Population|||percentage of participants|||Number
1266111|NCT00390806|Primary|Overall Survival|Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.|From the time of Randomization until the date of death due to any cause (up to 195 weeks)|Intent-to-Treat (ITT) Population: all randomized participants. Participants were analyzed by the treatment to which they were randomized, even if this differed from the treatment they actually received.|||months||95% Confidence Interval|Median
1266112|NCT00390780|Secondary|Treatment Compliance|Number of patients who were 100% compliant with the treatment regimen|Initiation of treatment to Day 14|ITT (all randomized patients who took at least 1 dose of study medication)|||participants compliant|||Number
1266113|NCT00390780|Secondary|Susceptibility of Candida Species by Microdilution Test|minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit|Initiation of treatment to Day 17 to 22|ITT (all randomized patients who took at least 1 dose of study medication), nonresponders (participants with progression to a higher visible lesion extent score or no reduction in oral lesion extent score at the test of cure [Day 17 to 22] visit)|||mcg/ml||Standard Deviation|Mean
1266114|NCT00390780|Secondary|Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet|Number of patients with detectable plasma concentration at Visit 3 (day 7)|7 days|ITT (all randomized patients who took at least 1 dose of study medication)|||participants|||Number
1266115|NCT00390780|Secondary|Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet|The mean durations of adhesion from initiation of treatment to Day 14 of miconazole Lauriad 50 mg mucoadhesive buccal tablet (or, in the case of the Clotrimazole troches treatment arm, the placebo mucoadhesive buccal tablet) were rounded to the nearest hour|14 days|ITT (all randomized patients who took at least 1 dose of study medication)|||hours||Full Range|Mean
1266117|NCT00390780|Secondary|Oral Discomfort Using Visual Analog Scale (VAS)|Visual analog scale was used by the patient in the patient diary. The scale ranged from 0 (no oral discomfort) to 10 (maximum oral discomfort)|14 days|Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)|||units on a scale||Full Range|Mean
1266118|NCT00390780|Secondary|Relapse at the Late Post-Therapy Visit (Day 35-38)|"Number of patients represents the number of participants who completed visit 6 (the late post-therapy visit on Days 35-38) and had been a clinical success at test-of-cure visit (visit 5). For this subset of participants, relapse was defined as a patient who responded to treatment by clinical cure or improvement (i.e., clinical success) on Days 17-22 at the test-of-cure visit (visit 5) and subsequently had an increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit on Days 35-38 (visit 6). No relapse indicates participants who were considered a clinical success at visit 5 and did not have a subsequent increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit (visit 6). The remaining number of participants in the Intent-to-Treat population who did not meet the criteria for relapse assessment at visit 6 is listed under Not Analyzed-ITT."|35 to 38 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
1266119|NCT00390780|Secondary|Mycological Cure at the Test of Cure Visit (Day 17-22)|"Mycological cure was defined as a patient who had no yeast isolated when oral specimens were cultured for fungi."|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
1266120|NCT00390780|Secondary|Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Partial response is having decrease in Murray extent of oral lesions score by at least 1 level and a stable Murray symptoms score, with partial symptom response defined as having a decrease in the Murray symptoms (soreness/burning) score by at least 1 level and a stable Murray extent of oral lesions score, and partial clinical/symptom response defined as decrease in Murray extent of oral lesions score by at least 1 level and a decrease in the Murray symptoms (soreness/burning) score by at least 1 level|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
1266121|NCT00390780|Secondary|Clinical Success at Day 7 (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|7 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
1266122|NCT00390780|Secondary|Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
1266123|NCT00390780|Secondary|Clinical Cure at Day 7 (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|7 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
1266124|NCT00390780|Primary|Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|17 to 22 days|"Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)~Per Protocol (PP, all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
1266125|NCT00390689|Secondary|Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period|Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week|baseline to week 52|Full Analysis Set (FAS).|||Percentage of patients|||Number
1266173|NCT00390416|Secondary|Patients With Measurable Disease the Confirmed Response Rate||up to 2 years||||percentage of participants||95% Confidence Interval|Number
1266126|NCT00390689|Secondary|Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period|PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.|baseline to week 52|Full Analysis Set (FAS).|||Percentage of patients|||Number
1266127|NCT00390689|Secondary|Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period|CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.|baseline to week 52|Full Analysis Set (FAS).|||Percentage of patients|||Number
1266128|NCT00390689|Secondary|Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period|ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)|Week 52 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Deviation|Mean
1266129|NCT00390689|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period|PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).|Week 52 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Deviation|Mean
1266130|NCT00390689|Secondary|IRLS Responder for Open-label Period|The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)|baseline to week 52|Full Analysis Set (FAS).|||Percentage of patients|||Number
1266131|NCT00390689|Secondary|Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period|The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe).|Week 52 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Deviation|Mean
1266132|NCT00390689|Secondary|Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.||baseline to 6 weeks||||participants|||Number
1266133|NCT00390689|Secondary|Patient Global Impression (PGI) Responder|PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.|baseline to week 6|Full Analysis Set (FAS).|||Percentage of patients|||Number
1266134|NCT00390689|Secondary|Clinical Global Impression Global Improvement (CGI-I) Responder|CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.|baseline to week 6|Full Analysis Set (FAS).|||Percentage of patients|||Number
1266135|NCT00390689|Secondary|Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks|ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)|Week 6 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Error|Least Squares Mean
1266136|NCT00390689|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks|PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).|Week 6 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Error|Least Squares Mean
1266137|NCT00390689|Secondary|IRLS Responder|The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)|baseline to week 6|Full Analysis Set (FAS).|||Percentage of patients|||Number
1266206|NCT00389818|Secondary|Event-free Survival at 1 Year||1 year post-treatment|||||||
1266207|NCT00389818|Secondary|Mortality and Cause of Death||At any time through the third year after treatment discontinuation|||||||
1266138|NCT00390689|Primary|Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks|The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.|Week 6 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Error|Least Squares Mean
1266139|NCT00390611|Secondary|Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib|Number of patients experiencing treatment-related adverse events|18 months||||participants|||Number
1266140|NCT00390611|Secondary|Overall Survival (OS)|Overall survival was measured from the date of study entry until the date of death|18 months||||months||95% Confidence Interval|Median
1266141|NCT00390611|Secondary|Overall Response Rate (ORR)|Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a > 50% decrease in the serum CA-125 level.|18 months||||participants|||Number
1266142|NCT00390611|Primary|2-year Progression-free Survival|The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years||||percentage of participants|||Number
1266143|NCT00390572|Primary|Sleep Quality|Changes in overall sleep quality were evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rating scale that yields a quantitative index of general sleep quality/disturbances. The PSQI is composed of 4 open-ended questions and 19 self-rated items (0-3 scale) assessing sleep quality and disturbances over a 1-month interval. The PSQI yields a global score of sleep quality ranging from 0 to 21. A score of <= 5 on the PSQI is considered normal sleep quality.|10 Months|Data from all participants were included in analyses.|||units on a scale||Standard Deviation|Mean
1266144|NCT00390572|Primary|Sleep Efficiency|Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.|10 Months after Baseline|Data from all participants was included.|||percentage of time in bed spent sleeping||Standard Deviation|Mean
1266145|NCT00390572|Secondary|Sleepiness|Changes in subjectively assessed daytime sleep propensity were measured using the Epworth Sleepiness Scale (ESS), a commonly employed in both sleep research and clinical applications. The ESS items inquire about the chance of dozing off in each 8 different situations. Responses are rated on a 4 point scale reflecting the respondents perceived likelihood of falling asleep. To quanitfy this outcome, the percentage of participants achieving normal sleep (less than 10 on ESS) was compared across arms at 10 months.|10 months||||percentage of participants|||Number
1266146|NCT00390572|Primary|Diary Sleep: Total Wake Time and Total Sleep Time|Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.|10 months||||minutes||Standard Deviation|Mean
1266147|NCT00390572|Primary|Provider Adherence to Sleep Specialist Recommendations|Provider outcomes included the provider’s number of participant sleep lab referrals, referrals to other specialty clinics for evaluation/treatment participant sleep problems, and presence of newly initiated sleep-focused therapies for participants. Information about these outcomes was obtained via review of provider orders and information included in notes entered into the VA’s computerized medical record system (CPRS). To quantify this outcome, the number of participants referred by providers for sleep-focused diagnostic tests and interventions was compared across arms.|10 months after baseline|Data was included for all participants.|||participants|||Number
1266148|NCT00390559|Primary|Subjective Effects|"The full scale name is the Urge to smoke visual analog scale (VAS). It measures self-reported urge to smoke. As with any VAS a word or phrase (in this case, Urge to Smoke is centered over a horizontal line anchored on the left by “not at all” and on the right by “extremely.” In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 (“not at all”) and the maximum score was 100 (“extremely”)."|6 hours|"Those who completed all four arms of the crossover study."|||units on a scale||Standard Deviation|Mean
1266149|NCT00390546|Secondary|Incidence of Adverse Outcomes in Infants With Propranolol or Digoxin|In relation to the study drugs|12 months||||participants|||Number
1266150|NCT00390546|Secondary|Number of Treated Patients Experiencing First SVT Recurrence|Infants treated with propranolol or digoxin|up to 110 days of treatment||||participants|||Number
1266151|NCT00390546|Primary|Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode.||6 months or until study endpoints were reached||||percentage of participants|||Number
1266152|NCT00390468|Primary|8-week Freedom-From-Progression (FFP)|Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.|8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.|Analysis was per protocol; Of 18 participants, only 15 were evaluable for efficacy.|||participants|||Number
1266153|NCT00390455|Other Pre-specified|Objective Tumor Response Rate for Participants With HER2-positive Tumors|Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy, had measurable disease and HER-2 positive disease were analyzed.|||percentage of participants||95% Confidence Interval|Number
1266154|NCT00390455|Other Pre-specified|Objective Tumor Response Rate for Participants With HER2-negative Tumors|Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy, had measurable disease and HER-2 negative disease were analyzed.|||percentage of participants||95% Confidence Interval|Number
1266155|NCT00390455|Other Pre-specified|Progression-free Survival for Participants With HER2-positive Tumors|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, whichever occurred first.|Up to 5 years|Participants who started protocol therapy and had HER2-positive disease were analyzed.|||months||95% Confidence Interval|Median
1266156|NCT00390455|Other Pre-specified|Progression-free Survival for Participants With HER2-negative Tumors|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first.|Up to 5 years|Participants who began protocol therapy with HER-2 negative tumors were analyzed.|||months||95% Confidence Interval|Median
1266157|NCT00390455|Secondary|Overall Survival (OS)|Overall survival was measured as the interval from study entry until death, from any cause, or last contact.|Study entry to death or last follow-up, up to 5 years|4 participants who never started protocol therapy were excluded.|||months||95% Confidence Interval|Median
1266158|NCT00390455|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy and had measurable disease were evaluated.|||percentage of participants||95% Confidence Interval|Number
1266159|NCT00390455|Primary|Progression-free Survival (PFS)|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).|Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years|4 participants who never received protocol therapy were excluded.|||months||95% Confidence Interval|Median
1266160|NCT00390429|Secondary|Correlation of EGFR Polymorphisms With Treatment Response and Clinical Outcome||Completion of study|Data were not collected.||||||
1266161|NCT00390429|Secondary|Correlation of Phospho-EGFR With Increased p27 and Clinical Outcome||Completion of study|Data were not collected.||||||
1266162|NCT00390429|Secondary|Correlation of Basal Levels of p27 With Response Rate and Overall Survival||Completion of study (up to 36 months)|Data were not collected.||||||
1266163|NCT00390429|Secondary|Correlation of Baseline EGFR Levels With Clinical Outcome||Completion of study (up to 36 months)|Data were not collected.||||||
1266164|NCT00390429|Secondary|Prognostic Significance of Epithelial Growth Factor Receptor (EGFR) Expression||Completion of study (up to 36 months)|Data were not collected.||||||
1266165|NCT00390429|Secondary|Frequency and Severity of Toxicities (Phase II)|Treatment-related adverse events Grade ≥3 by NCI CTCAE 2.0.|Completion of study (up to 36 months)||||participants|||Number
1266166|NCT00390429|Secondary|Progression-free Survival (Phase II)||Completion of study (up to 65 months)||||months||Full Range|Median
1266167|NCT00390429|Secondary|Overall Survival (Phase II)||Up to 65 months||||months||Full Range|Median
1266168|NCT00390429|Secondary|Maximum Tolerated Dose of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])|Maximum tolerated dose (MTD) defined as the highest dose level at which no more than one patient experienced DLT when at least 6 patients were treated at that dose level and were assessable for toxicity, graded according to NCI CTCAE 2.0.|up to 36 months|"Phase I, arm A, MTD: erlotinib 600-1000 mg d 2, 9, and 16; and docetaxel 70 mg/m^2 d 1 on a 21-d cycle.~Phase I, arm B, MTD: erlotinib 150-300 mg d 2 and 16; and docetaxel 70 mg/m^2 d 1 on a 21-d cycle."|||mg|||Number
1266169|NCT00390429|Secondary|Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])||up to 36 months||||participants|||Number
1266170|NCT00390429|Primary|Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.|||Participants|||Count of Participants
1266171|NCT00390429|Primary|Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004])||Up to 36 months||||Participants|||Count of Participants
1266172|NCT00390416|Primary|1-year Survival||1 year||||months||95% Confidence Interval|Median
1266174|NCT00390416|Primary|6 Month Progression Free Survival|as measured from the start of the treatment to the date of either documentation of disease progression or death. As we have previously, we will define progression of disease as per RECIST criteria. As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies).|6 months||||percentage of participants||95% Confidence Interval|Number
1266175|NCT00390364|Primary|Response Rate: The Total Number of Participants With Progression of Disease|"To determine response rate and time to tumor progression of patients with colorectal cancer and mutations in the PI3KCA gene who are treated with RAD001. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by CT (or MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.~The outcome measure will be the total number of subjects who show progression of disease."|1 month||||participants with progression of disease|||Number
1266176|NCT00390325|Secondary|Selected Polymorphisms of Genes Influencing Sorafenib Tosylate Metabolism and/or Resistance Genes That May Predict Response or Toxicity|Changes will be correlated with toxicity and clinical response to therapy.|Baseline|Due to low tumor cellularity in the samples obtained, such evaluation was not possible||||||
1266177|NCT00390325|Secondary|Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor|Percent of patients with RET mutations|Baseline||||Participants|||Count of Participants
1266178|NCT00390325|Secondary|Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0|Toxicities were graded for patients using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 4 weeks after last dose of sorafenib tosylate||||Participants|||Count of Participants
1266179|NCT00390325|Secondary|Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET)|Identify the median SUV at baseline and 8 week follow up as measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET).|Up to 4 weeks after last dose of sorafenib tosylate||||maximum SUV||Full Range|Median
1266180|NCT00390325|Secondary|Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor|Correlated with clinical response.|Up to 4 weeks after last dose of sorafenib tosylate|No data available||||||
1266181|NCT00390325|Secondary|Degree of Ras-MAPK Signaling Inhibition in the Tumor|Identify the number of patients with degree of Ras-MAPK signaling inhibition|Up to 4 weeks after last dose of sorafenib tosylate|Due to low tumor cellularity in the samples obtained, such evaluation was not possible||||||
1266182|NCT00390325|Secondary|Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep)|Median decrease in exchange rate Kep in index lesions|Up to 4 weeks after last dose of sorafenib tosylate|kep [exchange rate constant]|||percentage change||Full Range|Median
1266183|NCT00390325|Secondary|Patient With Decreased Carcinoembryonic Antigen (CEA) Levels|Identify the number of patients with decreased Carcinoembryonic Antigen (CEA) levels|Up to 4 weeks after last dose of sorafenib tosylate|1 patient was not evaluable in Arm B|||Participants|||Count of Participants
1266184|NCT00390325|Secondary|Number of Patients With Decreased Calcitonin Levels|Identifying the number of patients with decreased calcitonin levels|Up to 4 weeks after last dose of sorafenib tosylate|1 patient was not evaluable in Arm B|||Participants|||Count of Participants
1266185|NCT00390325|Primary|Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer|Measured using MRI scans. Determined using Response Evaluation Criteria in Solid Tumors/World Health Organization response criteria. 95% confidence interval will be calculated to estimate the frequency of response.|Up to 4 weeks after last dose of sorafenib tosylate|1 patient was not evaluable for RECIST evaluation in Arm B|||Participants|||Count of Participants
1266186|NCT00390234|Secondary|Survival (Carcinosarcoma Group)|Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.|Up to 3 years||||months||95% Confidence Interval|Median
1266187|NCT00390234|Primary|Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)||6 months||||months||95% Confidence Interval|Median
1266188|NCT00390234|Secondary|Survival (Leiomyosarcoma Group)|Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.|Up to 3 years||||months||95% Confidence Interval|Median
1266189|NCT00390234|Primary|Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)||6 months||||months||95% Confidence Interval|Median
1266190|NCT00390234|Primary|Objective Response Rate, Evaluated According to the RECIST Criteria||Up to 3 years||||participants|||Number
1266191|NCT00390221|Secondary|Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52|The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Responses use a 5 point Likert scale range from 1 to 5. All questions are to be answered. The total score is the sum of points for all 29 questions, with a minimum score of 29, and a maximum score of 145. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a subject's functioning.|Baseline and Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing).|||units on a scale||Standard Deviation|Mean
1266192|NCT00390221|Secondary|Proportion of Participants Who Relapsed at Week 52|Estimated cumulative proportion of participants relapsed at Week 52, based on the Kaplan-Meier product limit method. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis.|Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrawal from study were censored.|||proportion of participants|||Number
1266193|NCT00390221|Secondary|Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss.|Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing) with a non-missing value at baseline.|||lesions||95% Confidence Interval|Mean
1266194|NCT00390221|Secondary|Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24|Gd-enhancing lesions are detected when Gd leaks into a perivascular space due to local breakdown of the blood-brain barrier, indicating the presence of active inflammation. For participants with missing data the last valid nonbaseline measurement was carried forward if the participant was missing only 1 or 2 consecutive postbaseline scans. Otherwise the mean based on treatment group and visit was used as the imputed value. Estimated from a negative binomial model adjusted for the baseline number of Gd-enhancing lesions.|Week 8 through Week 24|Magnetic Resonance Imaging (MRI) Intensive Population: a protocol-defined subset of participants consisting of the first 307 participants enrolled in the study with non-missing baseline values.|||lesions||95% Confidence Interval|Mean
1266195|NCT00390221|Primary|Adjusted Annualized Relapse Rate Between Baseline and Week 52|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.|Baseline through Week 52|Intent to treat population: all randomized participants who received at least 1 dose of study medication (excluding 21 participants from a single site due to a protocol violation in dosing).|||relapses per person-years||95% Confidence Interval|Number
1266196|NCT00390182|Other Pre-specified|Time of Advanced/Recurrent Disease Without Distant Metastases.|Locally advanced/recurrent disease without distant metastases.|Participants were followed for an average of 8 years||||months||95% Confidence Interval|Median
1266197|NCT00390182|Other Pre-specified|Percentage of Participants With Distant Mestastases - Liver|Patients with distant mestastases to the liver|Participants were followed for an average of 8 years||||percentage of participants||95% Confidence Interval|Number
1266198|NCT00390182|Primary|Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 weeks||||participants|||Number
1266199|NCT00390013|Primary|Change From Baseline in Vulvar Pain|change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain.|19 weeks|study terminated early due to poor recruitment|||units on a scale||Full Range|Mean
1266200|NCT00389974|Primary|Objective Response Rate (PR or CR)|It is defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks. The 95% confidence interval for response rate will be calculated.|Up to 2 years|All patients evaluable for response|||percentage of evalubale patients||95% Confidence Interval|Number
1266201|NCT00389857|Other Pre-specified|Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.|"Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).~Note: Influenza vaccine-primed group did not receive vaccination 2"|0 to 3 days post-vaccination 2|"Safety analysis was on all enrolled and vaccinated participants, intend to treat population.~Influenza vaccine-primed group did not received vaccination 2"|||Participants|||Number
1266202|NCT00389857|Other Pre-specified|Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.|Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).|0 to 3 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population|||Participants|||Number
1266203|NCT00389857|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination|"GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation.~Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)"|14 days post-vaccination|Geometric mean titers were evaluated in the per-protocol population.|||Titer||95% Confidence Interval|Geometric Mean
1266204|NCT00389831|Primary|Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.|The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements would result in a score of 0 PLM per hour. Outcome is the average movements per hour in the 4 hour post-dose period per subject.|4 hours post-treatment period at each treatment day|Full Analysis Set|||PLM per hour||Standard Deviation|Mean
1266205|NCT00389831|Primary|Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo|Subjects rate the severity of the RLS symptoms at the start of each pre dose and post dose Suggested Immobilization Test (SIT-0 to SIT-6) and every 5min during each SIT, using a numeric symptoms severity scale, where 0=not severe and 10=very severe.|4 hours post-treatment period at each treatment day|Full Analysis Set|||score on a scale||Standard Deviation|Mean
1266208|NCT00389818|Secondary|Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time||After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||||||
1266209|NCT00389818|Secondary|Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue||Baseline, after cycles 4 and 6, 1 month after treatment discontinuation|||||||
1266210|NCT00389818|Secondary|Relationship Between MDR-1 Expression and Response to Treatment||Baseline|||||||
1266211|NCT00389818|Primary|Rate of Bacterial, Fungal, and Opportunistic Infections||After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||||||
1266212|NCT00389818|Primary|Median Survival Time||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||||||
1266213|NCT00389818|Primary|Duration of Response||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||||||
1266214|NCT00389818|Primary|Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||proportion of patients||95% Confidence Interval|Number
1266215|NCT00389805|Secondary|Effect of Bortezomib on Over Expression of NF-kB, BCL-2, and BCL-xL (Phase II)|Tumor levels of BCL-2, BCL-xL and BAX will be assessed by immunohistochemistry (IHC).|Up to 36 months|The Phase II study was not conducted.||||||
1266216|NCT00389805|Secondary|Importance of Folate-associated Gene Expression and Response or Outcome (Phase II)|Overexpression of reduced folate carrier (RFC) protein is thought to contribute to decreased resistance to pemetrexed. Levels of expression will be studied by measuring mRNA transcripts using quantitative Reverse Transcriptase-Polymerase Chain Reaction in archival patient tumor specimens.|Up to 36 months|The Phase II study was not conducted.||||||
1266217|NCT00389805|Secondary|Analysis of Molecular Determinants in Tumor Samples (Phase II)|Expression of relevant molecular targets of the proteasome, which is inhibited by bortezomib.|Up to 36 months|The Phase II study was not conducted.||||||
1266218|NCT00389805|Secondary|Number of Participants With Toxicities (Phase II)|Each adverse event will be determined by using the NCI CTCAE, Version 3.0.|Up to 36 months|The Phase II study was not conducted.||||||
1266219|NCT00389805|Secondary|Number of Participants With Response to Therapy as Measured by RECIST (Phase I)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence.|Up to 36 months|All patients for whom response evaluation measurements were recorded at baseline and after 2 cycles.|||Participants|||Count of Participants
1266220|NCT00389805|Secondary|Maximum Tolerated Dose of Bortezomib in Combination With Pemetrexel (Phase I)||Up to 36 months||||Mg/m^2|||Number
1266221|NCT00389805|Secondary|Number of Patients With Toxicity by NCI CTC v3.0 (Phase I)|Adverse events possibly related to treatment, graded according to the NCI CTCAE v3.0.|Up to 36 months||||participants|||Number
1266222|NCT00389805|Primary|Number of Patients Who Responded to Study Treatment (Phase II)|To determine the response rate of bortezomib in combination with pemetrexed in patients with advanced NSCLC. Response rate was assessed by CT scan. CT scans was performed at baseline and every two cycles (prior to 3rd and 5th cycle). The evaluation of response was based on standard RECIST criteria.|From start of treatment until disease progression/recurrence.|The Phase II study was not conducted.||||||
1266223|NCT00389805|Primary|Number of Patients With Grade ≥ 3 Toxicity (Phase I)|Grade 3/4 toxicity occurring in a patient within 1 cycle.|First cycle of treatment (3 weeks)||||participants|||Number
1266224|NCT00389805|Primary|Number of Participants Who Experience Adverse Events (Phase I)|Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 (Phase I).|Throughout the entire study (up to 36 months).||||Participants|||Count of Participants
1266225|NCT00389805|Primary|Number of Patients Experiencing a Dose-limiting Toxicity (Phase I)|Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion or lasting >7 days; febrile neutropenia; grade 3 neutropenia associated with infection; any other grade >/=3 non-hematologic toxicity considered by the investigator to be related to study drug.|Up to 36 months||||Participants|||Count of Participants
1266226|NCT00389597|Primary|Composite Definition of Study Success|"An individual subject in either treatment group was considered a success if the following criteria were met at 24 months:~Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of >= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of <30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities.~No study failures due to secondary surgical interventions at the index level~Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC"|2 Years|includes study failures, per protocol, that are carried forward for overall success|||percentage of subjects analyzed|||Number
1266227|NCT00389532|Primary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination|GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.|21 days post-vaccination|Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population|||Titer||95% Confidence Interval|Geometric Mean
1266256|NCT00389207|Secondary|Proportion of Patients Reporting Rash of Any Severity|Proportion of Patients reporting rash of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
1266228|NCT00389532|Primary|Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination|Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)|0-3 days post-vaccination|Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.|||Percentage of Participants|||Number
1266229|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)|Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF|||mL/min per 1.73 m2||Standard Deviation|Mean
1266230|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Serum Potassium|Value at end of treatment (up to 4 weeks) minus value at baseline|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF|||mg/dL||Standard Deviation|Mean
1266231|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Serum Creatinine|Value at end of treatment (up to 4 weeks) minus value at baseline|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF|||mg/dL||Standard Deviation|Mean
1266232|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure|Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo|Baseline to 4 weeks|Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)|||mm Hg||Standard Deviation|Mean
1266233|NCT00389519|Primary|Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure|Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo|Baseline to 4 weeks|Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)|||mm Hg||Standard Deviation|Mean
1266234|NCT00389493|Secondary|Brown Assessment of Beliefs (BABS)|"Scale ranges from 0 to 24 where 0 is beliefs are false and 24 is convinced beliefs = reality"|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
1266235|NCT00389493|Secondary|Hamilton Depression Rating Scale (Ham-D)|Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
1266236|NCT00389493|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form|QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
1266237|NCT00389493|Secondary|Social Adjustment Scale-SR|SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
1266238|NCT00389493|Primary|Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
1266239|NCT00389467|Secondary|Day 90 Mortality||at day 90||||participants|||Number
1266240|NCT00389467|Secondary|Symptomatic Hemorrhagic Transformation|"Symptomatic intracranial hemorrhage is defined as 4 point neurologic worsening on the National Institutes of Health Stroke Scale (NIHSS) score associated with parenchymal hematoma type 2 (PH-2*), remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage on imaging. The NIHSS is a scale measuring specific neurologic deficits caused by a stroke with scores ranging from 0 to 42, and higher scores indicating more severe neurologic deficits.~*from the modified European Cooperative Acute Stroke Study (ECASS) II criteria"|from baseline to day 7||||participants|||Number
1266241|NCT00389467|Primary|The Modified Rankin Scale Score|"Scale name is provided (Modified Rankin Scale) which is a standard measure of functional neurologic outcome in stroke. The scale runs from 0-6, running from perfect health without symptoms to death.~0 - No symptoms.~1 - No significant disability. Able to carry out all usual activities, despite some symptoms.~2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~3 - Moderate disability. Requires some help, but able to walk unassisted.~4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~6 - Dead."|at 90 days post-stroke||||units on a scale||95% Confidence Interval|Mean
1266242|NCT00389441|Secondary|Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life). Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Total average score range: 0 to 10. Lower scores indicated better outcome.|Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.|||units on a scale||Standard Deviation|Mean
1266257|NCT00389207|Secondary|Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities||week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
1266258|NCT00389207|Secondary|Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144|Calculations based on the MDRD algorithm.|From baseline to Week 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||mL/min/1.73 m^2||Standard Deviation|Mean
1266408|NCT00387621|Primary|Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment|Value at 60 minutes minus value at baseline.|baseline and 60 minutes|per protocol|||mEq/min||Standard Error|Mean
1266243|NCT00389441|Secondary|Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.|Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.|||units on a scale||Standard Deviation|Mean
1266244|NCT00389441|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline to death due to any cause or at least 2 year after the first dose for the last participant|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.|||weeks||95% Confidence Interval|Median
1266245|NCT00389441|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
1266246|NCT00389441|Secondary|Progression Free Survival (PFS)|PFS: Time in weeks from the start of study treatment to first documentation of objective disease progression or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study treatment plus 1) divided by 7. Progression is defined using RECIST, as >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since start of study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.|||weeks||95% Confidence Interval|Median
1266247|NCT00389441|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|Intent-to-Treat (ITT) population included all participants who were enrolled in the study and received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1266248|NCT00389324|Primary|Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)|Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).|IV Phase (21 or 28 days) at IV Visit #1, pre- and post-dose: 0 hr., 1 hr., and 1, 2, 3, 5, 7, 14, 21, and 28 days; SC Phase at Week #17, pre- and post-dose: 0 hr., and 1, 3, 4, 5, and 7 days|A total of 32 subjects in the IV phase and 26 subjects in the SC phase had sufficient plasma concentration of total IgG vs. time profiles (AUC) for assessment of steady-state PK parameters.|||mg*hr/ml||Standard Deviation|Least Squares Mean
1266249|NCT00389207|Secondary|Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144|Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||ratio||Standard Deviation|Mean
1266250|NCT00389207|Secondary|Change of Total Triglycerides From Baseline to Week 48, 96, 144|Change of total triglycerides from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||mg/dL||Standard Deviation|Mean
1266251|NCT00389207|Secondary|Change of hsCRP From Baseline to Week 48, 96, 144|Change of hsCRP from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||mg/L||Standard Deviation|Mean
1266252|NCT00389207|Secondary|Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144|Changes frombaseline apolipoprotein A1 & B|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||g/L||Standard Deviation|Mean
1266253|NCT00389207|Secondary|Change of Cholesterol Values From Baseline to Week 48, 96, 144|Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||mg/dL||Standard Deviation|Mean
1266254|NCT00389207|Secondary|Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity|Proportion of Patients reporting CNS (central nervous system) side effects of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
1266255|NCT00389207|Secondary|Proportion of Patients Reporting Hepatic Events of Any Severity|Proportion of Patients reporting hepatic events of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
1271392|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 12|Mean weekly evening peak expiratory flow at week 12, pre-dose|After 12 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
1266259|NCT00389207|Secondary|Time to Treatment Failure|Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count < 50 copies/mL up to Visit 10 (week 48) or loss of virologic response|baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||weeks||Inter-Quartile Range|Median
1266260|NCT00389207|Secondary|Time to Loss of Virologic Response (Rebound)|Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.|Baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||weeks||Inter-Quartile Range|Median
1266261|NCT00389207|Secondary|Time to Treatment Response (First Confirmed VL<50 Copies/mL)|Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response|baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||weeks||Inter-Quartile Range|Median
1266262|NCT00389207|Secondary|Proportion of Patients With Virologic Failure at Week 48, 96, 144||at Week 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||participants|||Number
1266263|NCT00389207|Secondary|Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144|The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)|at Week 24, 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
1266264|NCT00389207|Secondary|Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144|The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)|at Week 24, 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
1266265|NCT00389207|Secondary|Treatment Response at Week 144|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.|From baseline to Week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories.|||participants|||Number
1266266|NCT00389207|Secondary|Treatment Response at Week 96|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.|From baseline to Week 96|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||participants|||Number
1266267|NCT00389207|Secondary|Glycaemic Abnormalities|Number of patients with AE elevated serum glucose|From baseline to Week 144|FAS|||Patients|||Number
1266268|NCT00389207|Secondary|Serum Lipid Abnormalities|Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)|From baseline to Week 144|FAS|||patients|||Number
1266269|NCT00389207|Secondary|Lipodystrophy|Number of patients with AE lipodystrophy|From baseline to Week 144|FAS|||Patients|||Number
1266270|NCT00389207|Secondary|Treatment-emergent AIDS-defining Illness Leading to Death|Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.|From baseline to Week 144|FAS|||Patients|||Number
1266271|NCT00389207|Secondary|Treatment-emergent AIDS-defining Illness|Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment|From baseline to Week 144|FAS|||Patients|||Number
1266272|NCT00389207|Secondary|Genotypic Resistance Associated With Virologic Failure|Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.|From baseline to Week 48|All patients with virologic failure assessed for genotypic resistance|||Number of substitutions|||Number
1266273|NCT00389207|Secondary|Non-scheduled Physician Visits|Cost effectiveness assessment by number of patients with non-scheduled physician visits|From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT|FAS with varying numbers missing|||patients|||Number
1266274|NCT00389207|Secondary|Number of Patients Hospitalized|Cost effectiveness assessment by number of patients hospitalized|From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT|FAS with varying numbers missing|||Patients|||Number
1266275|NCT00389207|Secondary|Change in Physical Health Summary (PHS) Score From Baseline|QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing|||Units on a scale||Standard Deviation|Mean
1266276|NCT00389207|Secondary|Change in Mental Health Summary (MHS) Score From Baseline|Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing|||Units on a scale||Standard Deviation|Mean
1266514|NCT00386360|Secondary|Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266277|NCT00389207|Secondary|Change in Framingham Score From Baseline|Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing|||Units on a scale||Standard Deviation|Mean
1266278|NCT00389207|Secondary|Change in CD4+ Count From Baseline|Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit|||cells/mm^3||Standard Deviation|Mean
1266279|NCT00389207|Secondary|Proportion of Patients With VL < 400 Copies/ml|VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit|||Proportion of patients|||Number
1266280|NCT00389207|Secondary|Proportion of Patients With VL < 50 Copies/ml|VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit|||Proportion of patients|||Number
1266281|NCT00389207|Secondary|Treatment Response at Week 48 (TLOVR Algorithm)|Treatment response is defined as a VL <50 copies/mL measured at two consecutive visits up to Week 48 and without subsequent rebound or change of ARV therapy up to Week 48, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.|From baseline to Week 48|FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories|||Patients|||Number
1266282|NCT00389207|Primary|Treatment Response at Week 48|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.|From baseline to Week 48|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||Patients|||Number
1266283|NCT00389168|Secondary|Effects on Carotid Artery Wall Thickness|Changes in common carotid artery intima-media thickness, assessed by ultrasonography.|Baseline to 48 weeks||||mm||Standard Deviation|Mean
1266284|NCT00389168|Secondary|Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System|Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.|Baseline to 48 weeks||||pmol/L||95% Confidence Interval|Mean
1266285|NCT00389168|Secondary|Blood Pressure|Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks|Baseline to 48 weeks||||mm Hg||95% Confidence Interval|Mean
1266286|NCT00389168|Secondary|Left Ventricular Diastolic Function Assessed by the E/A Ratio|Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.|Baseline to 48 weeks||||ratio||Standard Deviation|Mean
1266287|NCT00389168|Primary|Changes in Left Ventricular Mass Index|Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2).|Baseline and 48 weeks|Data on echocardiography is not always available at all time points and for all participants. This is reflected by the number of observations, which sometimes are less than the number of participants.|||g/m^2||95% Confidence Interval|Mean
1266288|NCT00389168|Secondary|Number of Participants With Serious Adverse Events|Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.|Treatment period was baseline to 48 weeks||||Participants|||Number
1266289|NCT00389064|Secondary|Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)|Number of patients have adverse events associated with EPS|From start of the study teatment to last dose plus 30 days|Safety population|||Patients|||Number
1266290|NCT00389064|Secondary|Safety and Well Tolerated as Measured in Adverse Event|Number of patients have at least one adverse event|From the start of treatment to last dose plus 30 days|Safety population|||Participants|||Number
1266291|NCT00389064|Secondary|Change in the Visual Analogue Scale (VAS) Measuring Pain|Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization|Randomization to week 9|Modified Intent to Treat (MITT) population.|||mm||Standard Deviation|Least Squares Mean
1266292|NCT00389064|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization|Randomization to week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
1266293|NCT00389064|Secondary|Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission|"HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as:~If HAM-A total score≤7, THEN indicator=1~If HAM-A total score >7, THEN indicator=0"|Week 9|Modified Intent to Treat (MITT) population.|||Number of participants.|||Number
1266294|NCT00389064|Secondary|Hamilton Rating Scale for Anxiety (HAM-A) Response.|HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.|Week 9||||Number of participants.|||Number
1266297|NCT00389064|Secondary|Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score|CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
1266298|NCT00389064|Secondary|Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score|"Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.~Change : percentage at week 9 minus percentage at randomization"|Randomization to Week 9|In reporting Q-LES-Q there was missing data even with last observation carried forward (LOCF), so the total number of patients analyzed is 428 ( 211 Quetiapine XR and 217 Placebo).|||Percentage of Maximum Total Score||Standard Deviation|Least Squares Mean
1266299|NCT00389064|Primary|Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
1266300|NCT00388973|Secondary|Tolerability as Measured by Adverse Event Withdrawals During Treatment||Baseline to Week 9|All Randomized patients.|||Participants|||Number
1266301|NCT00388973|Secondary|Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)|The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on scale||Full Range|Median
1266302|NCT00388973|Secondary|Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10|The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on scale||Full Range|Median
1266303|NCT00388973|Secondary|Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on scale||Standard Deviation|Least Squares Mean
1266304|NCT00388973|Secondary|Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)|Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on a scale||Standard Deviation|Least Squares Mean
1266305|NCT00388973|Secondary|Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)|Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. Patients not on medication at baseline would have left the item blank and therefore no change from baseline could be calculated|||units on scale||Full Range|Median
1266306|NCT00388973|Secondary|Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)|Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||Percentage of Improvement||Standard Deviation|Least Squares Mean
1266307|NCT00388973|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.|MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on scale||Standard Deviation|Least Squares Mean
1266308|NCT00388947|Secondary|Prolapse Efficacy Success Rate|Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used.|24 months|Patients returning for a visit between 19-24 months post-procedure.|||percentage of participants||95% Confidence Interval|Number
1266309|NCT00388947|Primary|Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device||up to 2-years post-implant|All patients that met the inclusion/exclusion criteria.|||participants|||Number
1266310|NCT00388804|Primary|Prostate Specific Antigen (PSA) Failures|Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.|3 months up to 2 years|One person was not treated and therefore excluded from the analysis.|||participants|||Number
1266311|NCT00388726|Secondary|Safety Parameters: Adverse Events (AEs), Laboratory Parameters, Concomitant Medication, Electrocardiograms (ECGs), and Study Drug Exposure.||AEs and conmeds – until study termination; lab tests – Day 1 and weekly until study termination; ECGs - Day 1 and at study termination.|||||||
1271393|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 8|Mean weekly evening peak expiratory flow at week 8, pre-dose|After 8 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
1266313|NCT00388726|Secondary|Best Overall Response|Measured by RECIST criteria and defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.|Response Evaluable Population|||Percent of Participants|||Number
1266314|NCT00388726|Secondary|Progression-Free Survival.|Measured using Response Evaluation Criteria in Solid Tumors (RECIST) and defined as the time from the date of randomization until progressive disease or death from any cause in the absence of of progressive disease.|Until disease progression or death.|Intent to Treat|||Days||Full Range|Median
1266315|NCT00388726|Primary|Overall Survival|Defined as the time from the date of randomization until the date of death from any cause.|From date of randomization until death from any cause|Intent to Treat|||Days||Full Range|Median
1266316|NCT00388674|Secondary|Number of Participants With Liver-related Death|The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
1266317|NCT00388674|Secondary|Number of Participants With HCC Malignant Neoplasm|The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
1266318|NCT00388674|Secondary|Number of Participants With Non-HCC Malignant Neoplasm|The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
1266319|NCT00388674|Primary|Number of Participants With Liver-related HBV Disease Progression|The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
1266320|NCT00388674|Primary|Number of Deaths|The number of deaths, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
1266321|NCT00388674|Primary|Number of Participants With Adjudicated Overall Malignant Neoplasms|The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
1266322|NCT00388583|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus.~Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia."|Day 0 up to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population|||Participants|||Number
1266323|NCT00388583|Primary|Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40|Day 28 post-vaccination|Immunogenicity determination was in all per protocol population|||Participants|||Number
1266324|NCT00388583|Secondary|Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.|The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.|Pre- and Day 28 post-vaccination|Immunogenicity determination was in all per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1266325|NCT00388583|Primary|Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.|The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.|Pre-vaccination and Day 28 post-vaccination|Immunogenicity determination was in all per protocol population|||Participants|||Number
1266326|NCT00388505|Secondary|Hospitalization Due to Respiratory Events During the Study|The average number of days patients were hospitalized due to respiratory events during the course of the study.|25 Weeks|Patients in the intent-to-treat population who were hospitalized due to respiratory events.|||days||Standard Deviation|Mean
1266327|NCT00388505|Secondary|Antipseudomonal Antibiotic Usage During the Study|The average number of days patients required antipseudomonal antibiotics during the course of the study.|25 Weeks|Patients in the intent-to-treat population who required antipseudomonal antibiotics.|||days||Standard Deviation|Mean
1266328|NCT00388505|Secondary|Change From Baseline in Tobramycin Minimum Inhibitory Concentration|The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.|||μg/mL||Standard Deviation|Mean
1266329|NCT00388505|Secondary|Change From Baseline in Pseudomonas Aeruginosa Sputum Density|Three Pseudomonas aeruginosa biotypes were assessed in patient’s sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.|||log10 Colony forming units/g||Standard Deviation|Mean
1266330|NCT00388505|Secondary|Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication|Patient’s self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain.|Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).|Intent-to-treat population for whom data were available.|||Scores on a scale||Standard Deviation|Mean
1266331|NCT00388505|Secondary|Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1)|"Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit.~Relative change = 100 * ((Day 28 of Cycle 3 value – Baseline value)/ Baseline value)."|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.|||percent of predicted||Standard Deviation|Mean
1266332|NCT00388505|Secondary|Percentage of Participants With a Decrease From Baseline in Auditory Acuity|Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)|Audiology subpopulation|||percentage of participants|||Number
1266333|NCT00388505|Secondary|Serum Tobramycin Concentrations|Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart).|Weeks 1, 5, 17 and 21|Pharmacokinetic subpopulation|||μg/mL||Standard Deviation|Mean
1266334|NCT00388505|Primary|Number of Participants With Treatment-emergent Adverse Events|An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.|25 weeks|All Randomized Safety population.|||participants|||Number
1266335|NCT00388453|Secondary|Number of Reflux Events|Reflux event was calculated for a drop in pH from baseline to <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours||||reflux events||Inter-Quartile Range|Median
1266336|NCT00388453|Primary|Decrease in pH From Baseline to <6|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|||distal esophagus total % time pH <6||Inter-Quartile Range|Median
1266337|NCT00388453|Primary|Decrease in pH From Baseline to <5|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|||distal esophagus total % time pH <5||Inter-Quartile Range|Median
1266338|NCT00388453|Primary|Decrease in pH From Baseline to <4|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.|||distal esophagus total % time pH <4||Inter-Quartile Range|Median
1266339|NCT00388414|Primary|Neural Correlates of Pain Relief|"Scores reflect the average connectivity strength of that region of interest to the rest of the cortex.~There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3).~Subscales are averaged."|3 months||||Units on a scale||Standard Deviation|Mean
1266340|NCT00388414|Primary|Pain|"Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study.~Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine.~Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline.~Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100."|3 months||||Percentage change from baseline to end||Standard Deviation|Mean
1266341|NCT00388362|Secondary|Overall Survival|Administration of Sirolimus and Prednisone|3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus|23 patients that remained on the study for a median of 514 days (96-814 days), 2 died (1- second cancer and 1- progressive cardiac failure)|||participants|||Number
1266515|NCT00386360|Secondary|Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266342|NCT00388362|Primary|Clinical Activity|Determined by discontinuation of immunosuppression with resolution of all reversible CGVHD manifestations. Evaluated at 2 years after enrollment|3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus|23 patients that remained on the study for a median of 514 days (96-814 days). Numbers based on resolution/ improvement in clinical manifestations of cGVHD with a median of 90% reduction in prednisone dose and no additional immunosuppressive therapy over a two year treatment period.|||participants|||Number
1266343|NCT00388349|Secondary|Survival Measures|"Reports the survival measures:~Freedom from progression (FFP)~Event-free survival (EFS)~Overall survival (OS)~EFS and OS were estimated by Kaplan-Meier method~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|2 years|Lists the results as included in the publication, which included 92 participants who received the MTD treatment; completed the study; and had all data points collected|||percentage of patients||95% Confidence Interval|Number
1266344|NCT00388349|Secondary|Relapse Post-transplant|Reports the percentage of participants that experienced relapse post-transplant.|2 years|All participants|||percentage of participants|||Number
1266345|NCT00388349|Secondary|Overall Survival (OS)|Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).|2 years|All participants|||percentage of participants|||Number
1266346|NCT00388349|Secondary|Pulmonary Toxicity (BCNU Pneumonitis)|Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).|2 years|Patients who completed the study regardless of gemcitabine dose, and had all data points collected.|||participants|||Number
1266347|NCT00388349|Primary|Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity|Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.|6 months|7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study|||participants|||Number
1266348|NCT00388154|Primary|Overall Objective Response Rate (CR + PR)|Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD, no unequivocal progression of non-target lesions; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment.|Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.|Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable.|||percentage of participants|||Number
1266349|NCT00388154|Primary|Participant Responses|Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD.|Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.|Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable.|||participants|||Number
1266350|NCT00388037|Primary|Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Partial response is defined as a 30% decrease in the sum of the longest diameters of the target lesion maintained for at least 4 weeks; complete response is defined as complete disappearance of disease and cancer related symptoms maintained for at least 4 weeks. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.|Up to 3 years|All response evaluable patients|||percentage of evalubale patients||95% Confidence Interval|Number
1266351|NCT00387959|Primary|Survival at 1 Year After Transplantation|The number of patients survival status 1 year after transplantation|1 Year after transplant||||participants|||Number
1266352|NCT00387894|Secondary|Duration of Progress-free Survival (PFS)|Patients with stable or responding disease will continue treatment until tumor progression is determined|Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)||||participants|||Number
1266353|NCT00387894|Primary|Disease Response Measured Objectively by MRI of Brain|Lack of disease progression indicates response to treatment|Every 8 weeks or as indicated|5 participants evaluable while receiving study treatment|||participants|||Number
1266354|NCT00387881|Secondary|Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score|Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.|0 - 24 hours after treatment|ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188|||Score in scale||Standard Error|Mean
1266355|NCT00387881|Secondary|Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment|Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)|2 and 4 hours after treatment|ITT Population|||Participants|||Number
1266356|NCT00387881|Secondary|Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours|Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)|1-2 and 2-4 hours after treatment|ITT Population|||Participants|||Number
1266357|NCT00387881|Secondary|Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment|Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)|1-2, and 2- 4 hours after treatment|ITT Population|||Participants|||Number
1266358|NCT00387881|Secondary|Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment|Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.|0 - 24 hours after treatment|ITT Population|||Participants|||Number
1266359|NCT00387881|Secondary|Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment|Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.|0.5, 1, 2, and 4 hours after treatment|ITT Population|||Participants|||Number
1266360|NCT00387881|Secondary|Sustained Headache Relief 2-24 Hours After Treatment|Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.|2-24 hours after treatment|ITT Population|||Participants|||Number
1266361|NCT00387881|Secondary|Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment|Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.|0.5, 1, and 4 hours after Treatment|ITT Population|||Participants|||Number
1266362|NCT00387881|Primary|Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.|Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.|2 hours through 24 hours after Treatment|The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation.|||Participants|||Number
1266363|NCT00387829|Secondary|Radiological, Pain, and Functional Outcome Assessments|"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).~Pain (VAS): Visual Analog Score used to rate the subject’s pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.~Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100."|12 months|Data reported for patients evaluable at 12 months.|||Outcome scores||Standard Error|Least Squares Mean
1266364|NCT00387829|Primary|Radiological, Pain, and Functional Outcome Assessments|"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).~Pain (VAS): Visual Analog Score used to rate the subject’s pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.~Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100."|6 months|Data reported for patients evaluable at 6 months.|||Outcome scores||Standard Error|Least Squares Mean
1266365|NCT00387790|Secondary|The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.|Occurrence of serious toxicity defined as any grade 4 hematologic toxicity that persists for more than 7 days or requires platelet transfusions for a time period exceeding 7 days; any grade 3 or 4 non-hematologic toxicity with the exception of grade 3 nausea or vomiting which can be controlled within 7 days; grade 3 skin reaction; grade 3 transaminitis.|One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.|Only eligible patients are included in the analysis, therefore two patients were excluded.|||Participants|||Count of Participants
1266366|NCT00387790|Secondary|Overall Survival (OS)|Percentage probability of being alive 1 year following enrollment.|One year after enrollment.|Only eligible patients are included therefore two patients were excluded from analysis.|||percent probability||95% Confidence Interval|Number
1266367|NCT00387790|Primary|One Year Event-free Survival (EFS)|Percentage probability of being event-free at 1 year following enrollment.|One year after enrollment.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome. The 2 patients who are ineligible were excluded from the Outcome Measure analysis.|||percent probability||95% Confidence Interval|Number
1266368|NCT00387764|Secondary|Percentage of Participants Who Survived Until Month 12|For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.|From the first dose of study medication to Month 12|ATS Population|||Percentage of participants|||Number
1266369|NCT00387764|Secondary|Overall Survival (OS)|OS is defined as the interval between the date of the first dose of study medication to the date of death due to any cause. For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)|ATS Population|||months||95% Confidence Interval|Median
1266370|NCT00387764|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of the first dose of study medication and the date of disease progression as defined by the investigator or death due to any cause. RECIST was used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Participants who did not have disease progression or did not die were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)|ATS Population|||months||95% Confidence Interval|Median
1266371|NCT00387764|Secondary|Number of Participants With the Indicated Best Overall Response|The best overall response is defined as the best response recorded from the start of the treatment until disease progression (PD)/recurrence. Per RECIST: CR, the disappearance of all target and non-target lesions; PR, at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; SD, neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s); PD, at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Unknown/not evaluable is used for those participants who cannot be classified as achieving CR, PR, SD, or PD.|From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)|ATS Population|||participants|||Number
1266372|NCT00387764|Secondary|Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)|The number of participants who achieved either a CR, a PR, or a best response of SD that occurred at least 6 months after screening per RECIST criteria was assessed. CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; and SD is defined as neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s), as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response. A confirmed response of SD required that the SD assessment occurred no earlier than 12 weeks after the screening scans.|From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)|ATS Population. An analysis was performed on 71 participants.|||participants|||Number
1266373|NCT00387764|Secondary|Number of Participants With a Complete Response (CR) or Partial Response (PR)|Overall tumor response is defined as the number of participants achieving either a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). RECIST guidelines were used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. CR is defined as the disappearance of all target and non-target lesions, and PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as a reference the Baseline sum LD, as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response.|From Baseline to Week 24/investigational product discontinuation (up to 3.460 years)|ATS Population|||participants|||Number
1266374|NCT00387764|Primary|Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. A lengthened QT interval can be a biomarker for ventricular tachyarrhythmias. The QT interval corrected for heart rate using Bazett’s formula (QTcB) was calculated; the faster the heart rate, the shorter the QT interval. Electrocardiogram values (Bazett’s QTc value) were summarized using the following reference ranges: <450, 450 to 479, 480 to 499, 500 to 549, and >550 milliseconds.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed; 3 participants did not have post-Baseline results.|||participants|||Number
1266375|NCT00387764|Primary|Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline|Heart rate is the measure of heart beats per minute (bpm). The number of participants with a post-Baseline shift from Baseline in heart rate of <44 bpm, 44 to 100 bpm, 101 to 120 bpm, and >120 bpm was assessed.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1266376|NCT00387764|Primary|Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline|Blood pressure measurements included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). The number of participants with a post-Baseline shift from Baseline in blood pressure (<90 mmHg, 90 to 139 mmHg, 140 to 169 mmHg, >=170 mmHg) was assessed.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population|||participants|||Number
1266377|NCT00387764|Primary|Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline|Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC [leukopenia]), and prothrombin time international normalized ratio (PT [INR]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.|||participants|||Number
1266378|NCT00387764|Primary|Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline|Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.|||participants|||Number
1266379|NCT00387764|Primary|Median Time on Investigational Product|The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population|||Months||Inter-Quartile Range|Median
1266380|NCT00387764|Primary|Number of Participants With Adverse Events Related to Investigational Product|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the investigational product.|From Baseline to Follow-up (up to 6.230 years)|ATS Population|||participants|||Number
1266381|NCT00387764|Primary|Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.|From Baseline to Follow-up (up to 6.230 years)|ATP Population|||participants|||Number
1266382|NCT00387764|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.|From Baseline to Follow-up (up to 6.230 years)|All Treated Participants (ATP) Population: all enrolled participants who received at least one dose of open-label investigational product|||participants|||Number
1266383|NCT00387751|Secondary|Survival|Determined by time to progression, progression-free suvival, and overall survival.|6 months|Data were not collected||||||
1266384|NCT00387751|Secondary|Safety and Tolerability|Safety and tolerability of treatment, in terms of toxicity profile and incidence and rating of toxicity, according to NCI CTCAE v3.0 criteria.|6 months|Data were not collected||||||
1266385|NCT00387751|Primary|Response|"Clinical biologic activity of treatment, defined as the sum of complete response, partial response, and prolonged stable disease for ≥ 16 weeks, upon treatment with the combination of sorafenib and bevacizumab, in patients with advanced metastatic melanoma previously treated with immunotherapy or in previously untreated patients who are not appropriate candidates to receive IL-2-based treatment.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started of the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|4 months||||participants|||Number
1266386|NCT00387725|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Dose 1 up to 1 month after Dose 3||||percentage of participants|||Number
1266387|NCT00387725|Primary|Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3||1 month after Dose 3||||percentage of participants|||Number
1266388|NCT00387725|Primary|Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2||1 month after Dose 2||||percentage of participants|||Number
1266389|NCT00387712|Secondary|30 Foot Walk Time (Sec)|Participants are instructed to walk fast as comfortable on a straight pathway on the floor demarcated by cones. They may use their usual canes, walkers, and orthotics while they walk. The walks are timed, the value is the mean of three trials with an interval rest between each trial.|baseline to 6 month|Randomized study design with intent to treat group by time analysis of change in floor walking time between the higher-intensity treadmill training group and the lower intensity training group across baseline to 6 months post-exercise time points.|||sec||Standard Error|Mean
1266390|NCT00387712|Primary|Paretic Thigh Skeletal Muscle Myosin Heavy Chain Myosin Heavy Chain Isoform 2a|Skeletal muscle punch biopsies are obtained from the bilateral (paretic and non-paretic) vastus lateralis thigh muscle, at baseline and after 6 month interventions. Homogenized muscle messenger ribonucleic acid (mRNA) for myosin heavy chain isoforms are analyzed by real time polymerase chain reaction as fluorescent units with normalization to an acidic ribosomal protein, a housekeeping gene.|Baseline to 6 month|"The difference muscle and participant number reflects those that participated and completed pre/post biopsies.~Paretic thigh muscle, at baseline and after 6 month interventions, are analyzed for myosin heavy chain proportions. Values were the mean of duplicates run on polymerase chain reaction were normalized to a ribosomal protein mRNA."|||PCR flourescence units||Standard Error|Mean
1266391|NCT00387712|Primary|Cardiovascular Fitness (VO2 Peak)|Cardiovascular fitness is measured by collecting the expired gases during a progressive graded treadmill test.|Baseline to 6 month|Randomized study design with Intent to treat group by time analysis of change in peak cardiovascular fitness levels between the higher-intensity treadmill training group and the lower intensity training group across baseline to 6 months post-exercise time points.|||ml/kg/min||Standard Error|Mean
1266392|NCT00387673|Primary|Conduct pre-and Post-training Assessments of Behavioral Outcomes Using Wolf Motor Function Test and Jebsen Taylor Hand Function Test to Measure Upper Extremity Function, Hand-held Dynamometry to Measure Pinch Grip Strength, and Semmes-Weinstein Monofilam||Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing|Project has officially closed. PI for this project has left VA without forwarding information.||||||
1266393|NCT00387660|Secondary|Number of Participants With Toxicity|All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle.|Up to 36 months||||Participants|||Count of Participants
1266394|NCT00387660|Secondary|Median Survival of Patients Treated With This Regimen|The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.|||months||95% Confidence Interval|Median
1266395|NCT00387660|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.|||percentage of participants|||Number
1266396|NCT00387647|Secondary|Number of Participants With Adverse Events|Safety and tolerability of treatment as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0|48 months|All participants|||participants|||Number
1266397|NCT00387647|Secondary|Overall Survival (OS)|The secondary efficacy variable is overall survival measured as time to death, which is the time from remission until death from any cause.|48 months|All participants|||months||95% Confidence Interval|Median
1266398|NCT00387647|Primary|Rate of Disease Free Survival at One Year|The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with >5% blasts or the presence of Auer rods.|1 year|All participants|||percentage of participants|||Number
1266399|NCT00387621|Primary|Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV)|Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min||||pmol/min||Standard Deviation|Mean
1266400|NCT00387621|Primary|Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV)|Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min||||uEq/min||Standard Deviation|Mean
1266401|NCT00387621|Primary|Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV)|Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min||||pmol/min||Standard Deviation|Mean
1266402|NCT00387621|Primary|Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV)|Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min||||uEq/min||Standard Deviation|Mean
1266403|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of cGMP at 60 min on nesiritide treatment minus value of cGMP at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|60 minutes||||pmol/min||Standard Error|Mean
1266404|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of cGMP at 30 min on nesiritide treatment minus value of cGMP at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|30 minutes|intention to treat (ITT)|||pmol/min||Standard Error|Mean
1266405|NCT00387621|Secondary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of natriuresis at 60 min on nesiritide treatment minus value of natriuresis at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|60 minutes|intention to treat (ITT)|||mEq/min||Standard Error|Mean
1266406|NCT00387621|Secondary|Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of natriuresis at 30 min on nesiritide treatment minus value of natriuresis at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|30 minutes|intention to treat (ITT)|||mEq/min||Standard Error|Mean
1266407|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment|Value at 60 minutes minus value at baseline|baseline and 60 minutes|intention to treat (ITT)|||pmol/min||Standard Error|Mean
1266409|NCT00387426|Primary|Number of Participants With Objective Clinical Response to Sunitinib Therapy|Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).|After two 6-week treatment courses (12 weeks)|All participants assessed for response.|||participants|||Number
1266410|NCT00387348|Primary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.|4 weeks|Participants who had at least 1 follow up HAM-D assessment were included. Two participants died, one without a follow up assessment and one with a HAM-D at 2 weeks. For the participant who had the HAM-D at 2 weeks and then died, the last endpoint was carried forward.|||Change in HAM-D scores||Standard Deviation|Mean
1266411|NCT00387348|Secondary|Side Effect Burden|Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.|4 weeks|Participants who completed the 4 week assessment were analyzed|||units on a scale||Standard Deviation|Mean
1266412|NCT00387348|Primary|Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder|Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.|4 weeks|The efficacy analysis was intent to treat and all randomized participants were analyzed|||number of participants with response|||Number
1266413|NCT00387335|Secondary|Overall Survival|Time from start of treatment until death from any cause.|Up to two years||||weeks||Full Range|Median
1266414|NCT00387335|Secondary|Progression-free Survival|Time to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||weeks||Full Range|Median
1266415|NCT00387335|Primary|Feasibility of Treatment|Ability to remain on treatment without dose reduction|While patient remains on treatment, up to 30 weeks||||percentage of participants||95% Confidence Interval|Number
1266416|NCT00387335|Primary|Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|While patient remains on treatment, up to 30 weeks||||percentage of participants||95% Confidence Interval|Number
1266417|NCT00387153|Secondary|Antiproliferative Activity|Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.|Every 42 days|||||||
1266418|NCT00387153|Primary|Pharmacokinetics|Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.|First 5 days of treatment (Cycle 1)|||||||
1266419|NCT00387153|Primary|Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4.|"Dose limiting toxicities include any grade 3 nonhematological toxicity(excluding nausea/vomiting or alopecia); greater than grade 3 nausea/vomiting uncontrolled by aggressive antiemetic support; grade 4 neutropenia lasting more than 5 days, or any febrile (38.5° C or 101° F) grade 3/4 neutropenia; grade 4 thrombocytopenia.~An adverse event is any reaction, side effect, or other untoward event, regardless of relationship to MPC-2130 that occurs any time after the beginning of the first IV infusion of MPC-2130 until 30 days after MPC-2130 discontinuation."|First 21 days on treatment (Cycle 1)|A total of 8 subjects were enrolled in the study. Statistical analyses were intended to be descriptive since the goal for the study was to determine the maximum tolerated dose and general safety and tolerability of MPC-2130.|||Participants|||Number
1266420|NCT00387127|Other Pre-specified|Number of Participants Classified as Responders, as Per Volumetric Tumor Response|No analysis was not performed.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months|ITT Population. A formal analysis of this outcome measure was never performed; thus data are not available and cannot be reported.||||||
1266421|NCT00387127|Secondary|Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3|Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).|From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks|ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.|||Participants|||Number
1266432|NCT00387127|Secondary|Disease-specific Survival|Disease-specific survival is defined as the time from randomization until death due to head and neck cancer.|From the date of randomization until the date of death due to disease, assessed after a median of 13 months of follow-up|ITT Population. For participants who did not die, time to death was censored at the time of last contact.|||Months||Inter-Quartile Range|Median
1266445|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169|The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.|||Units on a scale||Standard Error|Least Squares Mean
1266422|NCT00387127|Secondary|Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3)|Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).|From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks|ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.|||Participants|||Number
1266423|NCT00387127|Secondary|Number of Participants Negative and Positive for Human Papilloma Virus (HPV) Infection, as Determined From Tumor Samples|"Analysis was performed for HPV infection analysis from the tumor biopsy samples obtained during the Screening period. p16 was used as a marker for HPV; thus, negative participants did not have the p16 marker."|Up to 28 days prior to the first dose of lapatinib/placebo|ITT Population|||Participants|||Number
1266424|NCT00387127|Secondary|Analysis of Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) From Tumor Samples|No analysis was performed for tumor sample RNA/DNA.|Screening|ITT Population. DNA/RNA from tumors has not been analyzed (tested); therefore, data are not available. No suitable analyses of DNA/RNA have been proposed for this small sample size of tumor samples.||||||
1266425|NCT00387127|Secondary|Plasma Proteome Analysis|Proteomic analyses of blood plasma samples were to be conducted to identify any changes in the proteome profile that could be related to the treatment response. Examination of pre-dosing (screening) plasma protein profiles could uncover novel blood-borne protein candidate biomarkers/profiles, which could be used to predict drug response.|From up to 28 days prior to the first dose of lapatinib/placebo start to 8 weeks after the first dose|ITT Population. Plasma proteome data have not been analyzed (tested); thus, data are not available to disclose. Based on the negative outcome of Study EGF102988 (NCT00424255), no suitable analyses have been proposed for this small sample size.||||||
1266426|NCT00387127|Secondary|Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha)|Paraffin-embedded tissue block (or sections) from archived tumor tissue sample, if available (from time of original diagnosis) or fresh tumor tissue, was sent for testing to determine intra-tumoral biomarker expression by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay. Stained tumor slides or tissue micro arrays (TMAs) were scored by a pathologist from 0 (no expression) to 3+ (high expression). An expression level of >=2+ was considered positive.|Up to 28 days prior to the date of the first dose of lapatinib/placebo start|ITT Population. Only those participants who had sufficient tumor sample for testing were analyzed.|||Participants|||Number
1266427|NCT00387127|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|Participants with OR were those who achieved either a CR or partial response (PR) from the assessment of overall tumor response at 6 months (24 weeks) following completion of CRT (data cut-off 30-Sep-2010). Per RECIST, CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the long diameter (LD) of target lesions, taking as a reference, the baseline sum LD. Data are based on Week 24 scans from participants receiving study treatment at that time point.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months|ITT Population|||Participants|||Number
1266428|NCT00387127|Secondary|Distant Relapse|Distant relapse is defined as the time from the date of randomization until the first occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ of part). Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.|From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months|ITT Population. If a participant had a distant metastasis and then died, then the participant was counted as having had an event of interest.|||Months||Inter-Quartile Range|Median
1266429|NCT00387127|Secondary|Number of Participants With Distant Recurrence of Initial Disease|Participants were analyzed for the occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ or part) after randomization in the study until data cut-off date 1-Aug-2014. Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.|From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months|ITT Population|||Participants|||Number
1266430|NCT00387127|Secondary|Loco-regional Control|Loco-regional control is defined as the time from the date of randomization until progression in the T or N site. Participants who died or had secondary primary malignancies in the head and neck region outside of the T and N site or distant metastasis were not counted as an event and were instead treated as competing risks. Per the TNM staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. Due to the minimal events reported (data cut-off 30-Sep-2010), valid analysis could not be performed for loco-regional control rate.|From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months|ITT Population||||||
1266431|NCT00387127|Secondary|Number of Participants With Loco-regional Recurrence of Initial Disease|Participants with loco-regional recurrence were those who had progression of disease in the T and N sites. Per the Tumor, Node, and Metastases (TNM) staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. If a participant had progression in the T or N sites, then the participant was counted as having had an event of interest.|From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months|ITT Population|||Participants|||Number
1266516|NCT00386360|Secondary|Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266433|NCT00387127|Secondary|Number of Participants Who Died Due to Progressive Disease|The number of participants who died due to progressive disease (a >=20% increase in the sum of the longest diameter of target lesions, or the appearance of >=1 new lesion, symptomatic progression and/or unequivocal progression of existing non-target lesions), or died due to head and neck cancer without evidence of disease progression, after randomization in the study is presented, using a data cut of 1 August 2014.|From the date of randomization until the date of death due to disease under study, assessed after a median of 30.9 months|ITT Population|||Participants|||Number
1266434|NCT00387127|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. Time to death (data cut-off 1-Aug-2014) was censored at the time of last contact for participants who did not die.|From the date of randomization until the date of death due to any cause, assessed after a median of 30.9 months|ITT Population|||Months||95% Confidence Interval|Median
1266435|NCT00387127|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS=the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Per RECIST, progressive disease=a >=20% increase in the sum of the longest diameter of target lesions (TLs), or the appearance of >=1 new L, symptomatic progression and/or unequivocal progression of existing non-TLs. For participants who did not progress or die at the time of reporting (data cut-off 1-Aug-2014), PFS data were censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy.|From the date of randomization until the date of disease progression or death due to any cause, assessed after a median of 22 months of follow-up|ITT Population|||Months||95% Confidence Interval|Median
1266436|NCT00387127|Secondary|Number of Participants With CR, as Assessed by the Investigator|Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the CRT, as determined by the investigator. Tumor response was assessed using modified RECIST criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.|From the date of randomization until 6 months post chemoradiation treatment, assessed after a median time of 13 months of follow-up|ITT Population|||Participants|||Number
1266437|NCT00387127|Primary|Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review|Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the chemoradiation treatment (CRT), as assessed by independent radiological review. Tumor response was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication|||Participants|||Number
1266438|NCT00387088|Secondary|Clinically Relevant Findings in Physical Examination and ECG|Clinically relevant findings in Physical Examination and ECG at end of treatment|End of treatment|Treated set|||participants|||Number
1266439|NCT00387088|Secondary|Marked Changes From Baseline in Vital Signs at End of Treatment|"Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.~SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.~DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.~PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm."|Baseline and end of treatment|Treated set|||participants|||Number
1266440|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.|||Litres||Standard Error|Least Squares Mean
1266441|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.|||Litres||Standard Error|Least Squares Mean
1266442|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 29|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FVC data.|||Litres||Standard Error|Least Squares Mean
1266443|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169|The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.|||Units on a scale||Standard Error|Least Squares Mean
1266444|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337|The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.|||Units on a scale||Standard Error|Least Squares Mean
1266507|NCT00386360|Secondary|Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12|ELISA / enzyme-linked immunosorbent assay method by central lab|Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266446|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337|The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.|||Units on a scale||Standard Error|Least Squares Mean
1266447|NCT00387088|Secondary|Number of Patients With at Least One Hospitalisation for a COPD Exacerbation|Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||participants|||Number
1266448|NCT00387088|Secondary|Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate|Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||hospitalisations for COPD exacerbations||Full Range|Median
1266449|NCT00387088|Secondary|Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted|Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||hospitalisations for COPD exacerbations||Full Range|Median
1266450|NCT00387088|Secondary|Time to First Hospitalisation for COPD Exacerbation|Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||Days||95% Confidence Interval|Median
1266451|NCT00387088|Secondary|Number of Patients With at Least One COPD Exacerbation|Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||participants|||Number
1266452|NCT00387088|Secondary|Number of COPD Exacerbations Per Patient - naïve Estimate|Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||COPD exacerbations||Full Range|Median
1266453|NCT00387088|Secondary|Number of COPD Exacerbations Per Patient - Exposure Adjusted|Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||COPD exacerbations per year||Full Range|Median
1266454|NCT00387088|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169|Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.|||Litres||Standard Error|Least Squares Mean
1266455|NCT00387088|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29|Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.|Baseline and Day 29|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data.|||Litres||Standard Error|Least Squares Mean
1266456|NCT00387088|Primary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||Days||95% Confidence Interval|Median
1266457|NCT00387088|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337|Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.|||Litres||Standard Error|Least Squares Mean
1266458|NCT00387036|Secondary|Exercise Endurance Time|Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.|2 Weeks|Intention to treat analysis. All patients were included.|||Minutes||Standard Deviation|Mean
1266459|NCT00387036|Primary|Standardized Dyspnea Score at Isotime During Exercise|"Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.~Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] )."|2 Weeks|Intention to treat analysis. All patients were included.|||Units on a Scale||Standard Deviation|Mean
1266460|NCT00387023|Primary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.|3 months||||participants|||Number
1266461|NCT00387010|Secondary|Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)|During the dose titration period, participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg if needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated. This outcome summarizes the successful dose levels identified during the titration period.|up to 10 days|Safety analysis set|||participants|||Number
1266462|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's enjoyment of life.|approximately week 5|Full analysis set|||participants|||Number
1266463|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's relationship with others.|approximately week 5|Full analysis set|||participants|||Number
1266464|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's ability to work and perform activities of daily living.|approximately week 5|Full analysis set|||participants|||Number
1266465|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's walking ability.|approximately week 5|Full analysis set. One participant was not assessed by the investigator.|||participants|||Number
1266466|NCT00387010|Secondary|Clinical Assessment of Patient Function - General Activities - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's general activities.|approximately week 5|Full analysis set|||participants|||Number
1266467|NCT00387010|Secondary|Patient Assessment of Ability to Enjoy Life at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to enjoy life.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
1266468|NCT00387010|Secondary|Patient Assessment of Ability to Have Sex at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to have sex.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
1266469|NCT00387010|Secondary|Patient Assessment of Ability to Participate in Social Events at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to participate in social events.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
1266470|NCT00387010|Secondary|Patient Assessment of Ability to Exercise at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to exercise.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
1266471|NCT00387010|Secondary|Patient Assessment of Ability to Walk at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to walk.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
1266472|NCT00387010|Secondary|Patient Assessment of Ability to Perform at Work at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to perform at work and includes both work outside the home and housework.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
1266508|NCT00386360|Secondary|Greater Trochanter BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266473|NCT00387010|Secondary|Patient Assessment of Ability to Go to Work at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to go to work.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
1266474|NCT00387010|Secondary|Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5|The summary question from the Pain Flare Treatment Satisfaction Questionnaire asked participants which medication they preferred to use for their break-through pain. Options were 1) Prior medication 2) Study medication 3) no preference|approximately week 5|Full analysis set of participants who answered the questions.|||participants|||Number
1266475|NCT00387010|Secondary|Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5|Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Multidimensional Pain Inventory Subscales. Answers to questions in the MPI are captured on a 7-point scale, with 0=most positive answer and 6= least positive answer. Twenty questions focus on pain, fourteen on a significant other's response when participant is in pain, and eighteen questions about daily activities. There are a total of 13 subscales with variable ranges. Subscales and corresponding ranges are listed in the results table. The General Activity category combines the Household Chores, Outdoor Work, Activities Away from Home, and Social Activities categories.|Day 0 (baseline), approximately week 5|Full analysis set|||units on a scale||Standard Deviation|Mean
1266476|NCT00387010|Secondary|Change From Baseline in the Beck Depression Inventory at Approximately Week 5|Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Beck Depression Inventory (BDI). The BDI is a self-reporting instrument that asks 21 questions regarding how the participant felt in the past few days. Answers are in sentence form, and offer a scale where the first answer (worth 0 points) indicates no depression and the fourth answer (worth 3 points) indicates significant depression. Totals (0-63) are grouped so that totals of 1-10 are interpreted as 'These ups and downs are considered normal' and scores >40 indicate extreme depression.|Day 0 (baseline), approximately week 5|Full analysis set of participants who answered the questions.|||units on a scale||Standard Deviation|Mean
1266477|NCT00387010|Secondary|Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5|The change from baseline to approximately week 5 in the PASS subscale scores. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. Those 40 questions are organized into four subscales: fear, cognitive anxiety, somatic anxiety, and escape/avoidance. Each subscale score is obtained by summing the answers to the ten items in the subscore resulting in a range of 0-50.|Day 0 (baseline), approximately week 5|Full analysis set|||units on a scale||Standard Deviation|Mean
1266478|NCT00387010|Primary|Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5|The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.|Day 0 (baseline), approximately week 5|Full analysis set|||units on a scale||Standard Deviation|Mean
1266479|NCT00386880|Primary|Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine|Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.|Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.||||participants|||Number
1266480|NCT00386776|Secondary|Completeness of Patients' Problem Lists|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.||||||||
1266481|NCT00386776|Secondary|Number of Telephone Calls and E-mail Messages Between Patients and Physicians|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.||||||||
1266482|NCT00386776|Secondary|Time Per Visit|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.||||||||
1266483|NCT00386776|Secondary|Number of Office Visits by Patients|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.||||||||
1266484|NCT00386776|Primary|Physician Post Visit Questionnaire|"The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the physician at the time of the patient visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the questions “How helpful was it for your patient to have taken the computer interview before seeing you?~” and the question To what extent do you think the computer summary helped you to provide better care to your patient? We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the physician responses to the post-visit questionnaires when physicians filled out the questionnaire but their patients did not."|One day after the patient visit|We analyzed post visit physician questionnaire responses for the patients who completed the medical history and who showed up for their appointment.|||units on a scale||Full Range|Mean
1266485|NCT00386776|Primary|Patient Post Visit Questionnaire|The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the patient at the time of the visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the question “How helpful was it for you to have taken the computer interview before seeing your doctor?” We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the responses of three of the patients whose doctors did not complete their post-visit questionnaire.|One day after the visit with the physician|We analyzed post medical history questionnaire responses for the 23 patients who completed the medical history patients.|||units on a scale||Full Range|Mean
1266509|NCT00386360|Secondary|Femoral Neck BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266486|NCT00386776|Primary|Patient Post Medical History Assessment Questionnaire|"The questionnaire consisted of 10 Likert scales questions assessing the computer-based history. The Likert scale ranged from 1 for 'Not at all' to 10 for 'Very'.~We computed the mean of the responses to the question “How helpful were the questions when thinking about your health? We also calculated a total score by averaging the mean scores of the 10 questions."|Immediately after taking the medical history|We analyzed post medical history questionnaire responses for the 32 patients who completed the medical history patients.|||units on a scale||Full Range|Mean
1266487|NCT00386607|Secondary|Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment||Month 18|Treated population|||Percentage of patients|||Number
1266488|NCT00386607|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure||Baseline and Month 18|Treated population|||mmHg||Standard Deviation|Mean
1266489|NCT00386607|Primary|Overall Percentage of Patients With Adverse Events|adverse event data obtained from both the core study and the 6 month extension study.|Month 18||||percentage of patients|||Number
1266490|NCT00386607|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure||Baseline and Month 18|Treated population|||mmHg||Standard Deviation|Mean
1266491|NCT00386607|Secondary|Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg||.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54|Treated population|||Percentage of patients|||Number
1266492|NCT00386607|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure.||Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54|Treated population|||mmHg||Standard Deviation|Mean
1266493|NCT00386607|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure.||Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54|Treated population|||mmHg||Standard Deviation|Mean
1266494|NCT00386607|Primary|Overall Percentage of Patients With Adverse Events||Month 12|Treated population: All patients who received at least one dose of Aliskiren/Valsartan|||percentage of patients|||Number
1266495|NCT00386477|Primary|Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.|Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.|1 month|Randomization|||participants|||Number
1266496|NCT00386425|Post-Hoc|Mortality for Moderate Protein C Deficiency by Infusion Duration||28 Days|ITT Population - ITT Switch-No Population, ITT patients who did not answer yes to the switch question.|||percent participants deceased|||Number
1266497|NCT00386425|Other Pre-specified|Mortality for Severe Protein C Deficiency|Twenty-eight day mortality is the patient's mortality status at the predefined timepoint of 672 hours from the start of study drug infusion. Hospital mortality is the patient's survival status at the end of the hospital stay or study day 90 (if the patient remains in the hospital).|28 Days, up to 90 days|ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy. ITT patients with severe protein C deficiency. Severe deficiency is defined by the 24-hour local laboratory protein C value reported to the Interactive voice response system (IVRS).|||Percentage of participants|||Number
1266498|NCT00386425|Secondary|Mortality by Protein C Normalized Versus Not-normalized|Normalization was defined as having 2 consecutive protein C measurements above the lower limit of normal through Study Day 7.|28 days|ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy|||Percentage of participants|||Number
1266499|NCT00386425|Secondary|Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period|Serious bleeding events (SBE): intracranial hemorrhage, life-threatening or fatal bleed, or bleeding event assessed as an SAE. Patients may have multiple events with onset in different time periods. SAEs include SBEs. The 3 SBEs in Alternative-Moderate Deficiency arm (days 5-8) occurred after completion of study drug infusion. One event (pleural haemorrhage) occurred same day of completion of infusion and 2 events (cerebral haemorrhage, shock haemorrhagic) occurred day after completion.|Day 0 through Day 28|Randomized participants who received randomized therapy (intention to treat population).|||number of patients with at least 1 event|||Number
1266500|NCT00386425|Secondary|28-Day Time Averaged Sequential Organ Failure (SOFA) Score|The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction). SOFA scores were time-averaged.|Day 0, Day 28|ITT population|||Units on a scale||Standard Deviation|Mean
1266501|NCT00386425|Secondary|Hospital Mortality (up to Day 90)||Day 0 to hospital discharge or Day 90|ITT population|||Percentage of participants|||Number
1266502|NCT00386425|Secondary|Day 28 All-Cause Mortality||Day 0 through Day 28|ITT population|||percentage of participants|||Number
1266503|NCT00386425|Secondary|Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency|"Moderate Protein C Deficiency: A protein C level greater than half the lower limit of normal.~Severe Protein C Deficiency: A protein C level less than or equal to half the lower limit of normal."|Day 1, Day 7|ITT moderately deficient population, ITT severely deficient population|||Percent Protein C Activity||Standard Deviation|Mean
1266504|NCT00386425|Primary|Mean Change in Protein C Levels From Day 1 to Day 7|Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.|Day 1, Day 7|Intent to Treat (ITT) Last Observation Carried Forward (LOCF) population.|||Percent Protein C Activity||Standard Deviation|Mean
1266505|NCT00386360|Secondary|Height, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266506|NCT00386360|Secondary|Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12|Electrochemiluminescence assay method by central lab|Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266510|NCT00386360|Secondary|Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266517|NCT00386360|Secondary|Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|Per Protocol (PP) Population - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266518|NCT00386360|Primary|Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|Primary Efficacy Population - all patients in ITT population who had no major protocol violations and had an evaluable distal radius BV/TV (trabecular bone volume to tissue volume) at baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1266519|NCT00386334|Secondary|Mean Sheehan Disability Total Scores|Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16).|Weeks 0,6,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266520|NCT00386334|Secondary|Mean Change From Baseline in the Sheehan Disability Scale Total Score.|Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266521|NCT00386334|Secondary|Mean Mental Component Summary of the Short Form-36 Scale Scores|This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16).|Weeks 0,6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266522|NCT00386334|Secondary|Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores|Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266523|NCT00386334|Secondary|Mean Physical Component Summary of the Short Form-36 Scale Scores.|This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).|Weeks 0,6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266524|NCT00386334|Secondary|Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale|Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6, 12, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266525|NCT00386334|Secondary|Mean Insomnia Severity Index Total Scores at Various Study Time Points|The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266526|NCT00386334|Secondary|Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points|Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266527|NCT00386334|Secondary|Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
1266528|NCT00386334|Secondary|Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points|The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||percentage of total asleep time||Standard Deviation|Median
1266529|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points|Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||percentage of total asleep time||Standard Deviation|Mean
1266530|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.|Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||percentage of total asleep time||Standard Deviation|Mean
1266531|NCT00386334|Secondary|Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.|The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266532|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points|Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266533|NCT00386334|Secondary|Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||minutes||Standard Deviation|Mean
1266534|NCT00386334|Secondary|Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points|The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||number of naps||Standard Deviation|Mean
1266535|NCT00386334|Secondary|Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points|Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||number of naps||Standard Deviation|Mean
1266536|NCT00386334|Secondary|Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||number of naps||Standard Deviation|Mean
1266537|NCT00386334|Secondary|Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||number of awakenings||Standard Deviation|Mean
1266538|NCT00386334|Secondary|Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||number of awakenings||Standard Deviation|Mean
1266539|NCT00386334|Secondary|Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||number of awakenings||Standard Deviation|Mean
1266540|NCT00386334|Secondary|Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points|Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).|weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266541|NCT00386334|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266542|NCT00386334|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||minutes||Standard Deviation|Mean
1266543|NCT00386334|Secondary|Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.|Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) & average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266544|NCT00386334|Secondary|Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points|Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266545|NCT00386334|Secondary|Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||minutes||Standard Deviation|Mean
1266546|NCT00386334|Secondary|Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points|Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values).|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1267559|NCT00379912|Secondary|Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles||Six months|Analysis of percent apoptosis was undertaken irrespective of arm assignment and categorized between responsers and non-responders|||percentage of cells||Standard Error|Mean
1266547|NCT00386334|Secondary|Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points|Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266548|NCT00386334|Secondary|Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||minutes||Standard Deviation|Mean
1266549|NCT00386334|Secondary|Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points|Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||percentage of total asleep time||Standard Deviation|Median
1266550|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points|Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||percentage of total asleep time||Standard Deviation|Mean
1266551|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||percentage of total asleep time||Standard Deviation|Mean
1266552|NCT00386334|Secondary|Mean Subject-Reported Total Nap Time at Various Study Time Points|The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266553|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.|Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266554|NCT00386334|Secondary|Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||minutes||Standard Deviation|Mean
1266555|NCT00386334|Secondary|Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.|The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||number of naps||Standard Deviation|Mean
1266556|NCT00386334|Secondary|Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points|Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||number of naps||Standard Deviation|Mean
1266557|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose)- week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||number of naps||Standard Deviation|Mean
1266558|NCT00386334|Secondary|Mean Subject-reported Physical Well-Being at Various Study Time Points|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266559|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266560|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
1266561|NCT00386334|Secondary|Mean Subject-reported Ability to Concentrate at Various Study Time Points|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266562|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266563|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseliine (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
1266564|NCT00386334|Secondary|Mean Subject-reported Ability to Function at Various Study Time Points|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266565|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266566|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
1266567|NCT00386334|Secondary|Mean Subject-reported Daytime Alertness at Various Study Time Points.|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266568|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266569|NCT00386334|Secondary|Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
1266570|NCT00386334|Secondary|Mean Subject-reported Depth of Sleep at Various Study Time Points|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266571|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266572|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
1266573|NCT00386334|Secondary|Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points|Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266574|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.|Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1266575|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period|Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
1266576|NCT00386334|Secondary|Mean Number of Awakenings (Subject-reported) at Various Study Time Points|Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||number of awakenings||Standard Deviation|Mean
1266577|NCT00386334|Secondary|Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.|The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||number of awakenings||Standard Deviation|Mean
1266578|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.|The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||number of awakenings||Standard Deviation|Mean
1266579|NCT00386334|Secondary|Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266580|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266581|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.|Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose) -week 12|Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.|||minutes||Standard Deviation|Mean
1266582|NCT00386334|Secondary|Mean Subject-reported Sleep Latency Reported at Various Study Time Points.|Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266583|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points|Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266584|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.|Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||minutes||Standard Deviation|Mean
1266585|NCT00386334|Secondary|Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.|The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).|Weeks 0, 3, 6, 9, 12, 14, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
1266586|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.|The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.|Weeks 0, 3, 6, 9, 12, 14, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.|||minutes||Standard Deviation|Mean
1266587|NCT00386334|Primary|Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.|The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose)-12 weeks|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.|||minutes||Standard Deviation|Mean
1266588|NCT00386308|Primary|Mean Reduction From Baseline in Menstrual Blood Loss (MBL)|reduction of menstrual blood loss in mL|Baseline MBL over 6 menstrual cycles|modified intent to treat population|||mL||Standard Deviation|Least Squares Mean
1266589|NCT00386308|Secondary|Responder Analysis - Reduction in Large Stains|Percentage of subjects who experienced a reduction from baseline in the frequency of large stains|Reduction from Baseline over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||percentage of subjects|||Number
1266590|NCT00386308|Secondary|Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding|A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Change from Baseline scores over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||units on a scale||Standard Deviation|Least Squares Mean
1266591|NCT00386308|Secondary|Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding|A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Change from Baseline scores over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||units on a scale||Standard Deviation|Least Squares Mean
1266592|NCT00386256|Primary|HB/Phone Adherence|An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100. This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.|Monthly over 3 months||||percentage of days adhered||Standard Deviation|Mean
1266593|NCT00386256|Primary|Exercise Adherence|An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100. This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.|at monthly intervals, for 3-months||||percentage of days adhered||Standard Deviation|Mean
1266594|NCT00386243|Primary|Brief Pain Inventory (Interference)|"This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents no interference and 10 is completely interferes. The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7)."|Baseline and 9 months||||units on a scale||Standard Deviation|Mean
1266595|NCT00386243|Secondary|Pain Self-efficacy (Arthritis Self-efficacy Scale)||at baseline, 3, 6, and 9 months|||||||
1266596|NCT00386243|Secondary|Generic HRQL (SF-12)||at baseline, 3, 6, and 9 months|||||||
1266597|NCT00386243|Secondary|Work Function (Work and Health Interview)||at baseline, 3, 6, and 9 months|||||||
1266598|NCT00386243|Secondary|Clinical Response (Global Rating of Change)||at baseline, 3, 6, and 9 months|||||||
1266599|NCT00386243|Secondary|Psychological Distress (PHQ-9, MCS Score of SF-12, PRIME-MD Anxiety, PTSD Checklist (PCL-17))||at baseline, 3, 6, and 9 months|||||||
1266600|NCT00386243|Primary|Roland-Morris Disability Questionnaire|This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.|at baseline and 9 months||||scores on a scale||Standard Deviation|Mean
1266601|NCT00386152|Secondary|Number of Patients (Hb >= 11 g/dL) During Study.||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit|||participants|||Number
1266602|NCT00386152|Secondary|Time to Achieve Hb >= 11 g/dL During Study||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit|||days||95% Confidence Interval|Median
1266603|NCT00386152|Primary|Hemoglobin (Hb) Change From Baseline to Study Week 7|Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication|Baseline (Week 1) and Week 7|per-protocol (PP) population that includes a subset of the modified intent-to-treat (mITT) population with subjects who were randomized and received at least one dose of study medication, had transfusion-unrelated Hb values obtained at both baseline and Week 7, met inclusion and exclusion criteria, and had no major protocol violations up to Week 7|||g/dL||Standard Deviation|Mean
1266604|NCT00386152|Secondary|Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit|||participants|||Number
1266605|NCT00386100|Secondary|Percent Change From Baseline in Bone Alkaline Phosphatase (BSAP) at Weeks 20, 56, and 80|Blood was taken for measurement of BSAP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BSAP measurements at Week 20 or later were included.|||percent change|||Number
1266606|NCT00386100|Secondary|Percent Change From Baseline in Procollagen Type-1 N-propeptide (P1NP) at Weeks 20, 56, and 80|Blood was taken for measurement of P1NP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with P1NP measurements at Week 20 or later were included.|||percent change|||Number
1266628|NCT00386100|Secondary|Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80|Blood was taken for serum FPG measurements. FPG responders were described as participants having achieved FPG <=6 mmol/L (110 mg/dL) and <7 mmol/L (126 mg/dL) Hb1AC at Week 80 with LOCF from Week 32.|Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||participants|||Number
1266607|NCT00386100|Secondary|Percent Change From Baseline in C-terminal Telopeptide (CTX) at Weeks 20, 56, and 80|Blood was taken for measurement of CTX. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with CTX measurements at Week 20 or later were included.|||percent change|||Number
1266608|NCT00386100|Secondary|Percent Change From Baseline in Estradiol at Weeks 20, 56, and 80|Blood was taken for measurement of estradiol. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of female participants in the bone study only. n is the number of evaluable participants, which is the number of female participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with estradiol measurements at Week 20 or later were included.|||percent change|||Number
1266609|NCT00386100|Secondary|Percent Change From Baseline in 25-hydroxy Vitamin D at Week 80|Blood was taken for measurement of 25-hydroxy vitamin D. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with 25-hydroxy vitamin D measurements at Week 20 or later were included.|||percent change|||Number
1266610|NCT00386100|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone at Week 80|Blood was taken for measurement of intact parathyroid hormone. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with intact parathyroid hormone measurements at Week 20 or later were included.|||percent change|||Number
1266611|NCT00386100|Secondary|Percent Change From Baseline in Serum Calcium at Weeks 12, 32, 56, and 80|Blood was taken for measurement of serum calcium. Percent change from baseline was based on log transformed data. Geometric mean, GM; standard error, SE. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 12, 32, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with serum calcium measurements at Week 20 or later were included.|||percent change|||Number
1266612|NCT00386100|Secondary|Percent Change From Baseline in Total Body BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
1266613|NCT00386100|Secondary|Percent Change From Baseline in Distal Radius BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
1266614|NCT00386100|Secondary|Percent Change From Baseline in Femoral Neck BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
1266615|NCT00386100|Secondary|Percent Change From Baseline in Trochanter BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
1266616|NCT00386100|Secondary|Percent Change From Baseline in Total Hip BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
1266617|NCT00386100|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mass Density (BMD) at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100%. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
1266618|NCT00386100|Secondary|Number of Participants at Final Dose Level||Baseline to Week 80 or withdrawal|Safety population. This population consisted of all participants who were randomized and received at least one dose of the study medication.|||participants|||Number
1266619|NCT00386100|Secondary|Slope of Delta-cell Function as Estimated by the Ratio deltaI/deltaG|The ratio Delta I/Delta G is calculated based on the oral glucose tolerance test (OGTT), where Delta I = (30 minute immunoreactive insulin minus 0 minute immunoreactive insulin) and Delta G = (30 minute plasma glucose minus 0 minute plasma glucose). The 0 minute values are fasting insulin and glucose; the 30 minute values are taken 30 minutes after the oral glucose challenge. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants from US and Mexico sites with a value at baseline and at the specified visit, were analyzed.|||ratio||Standard Error|Mean
1266620|NCT00386100|Secondary|Percent Change From Baseline in in HOMA-S and HOMA-B to Week 80 (US and Mexico Subset of Participants)|Blood was taken for measurement of homeostasis model assessment for insulin sensitivity (HOMA-S) and beta-cell function (HOMA-B). Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only. GM, geometric mean; SE, standard error.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change|||Number
1266621|NCT00386100|Secondary|Change in C-peptide From Baseline at Week 80 (US and Mexico Subset of Participants)|Blood was taken for C-peptide measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||mmol/l||Standard Error|Mean
1266622|NCT00386100|Secondary|Change in Fasting Insulin From Baseline at Week 80 (US and Mexico Subset of Participants)|Blood was taken for fasting insulin measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||picomoles per Liter (pmol/l)||Standard Error|Mean
1266623|NCT00386100|Secondary|Percent Change in Free Fatty Acids (FFA) From Baseline at Week 80 (US and Mexico Subset of Participants).|Blood was taken for measurement of FFA. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change|||Number
1266624|NCT00386100|Secondary|Percent Change From Baseline in C-reactive Protein (CRP) at Week 80 (US and Mexico Subset of Participants)|Blood was taken for measurement of CRP. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change|||Number
1266625|NCT00386100|Secondary|Percent Change From Baseline in Adiponectin at Week 80 (United States [US] and Mexico Subset of Participants )|Blood was taken for measurement of adiponectin. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change|||Number
1266626|NCT00386100|Secondary|Percent Change From Baseline in Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Triglycerides at Week 80|Blood was taken for measurement of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Percent change from baseline at Week 80 was based on log transformed data. Geometric mean, GM; standard error, SE. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 32 evaluable population with LOCF from Week 32. n is the number of evaluable participants, which is defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest.|||percent change|||Number
1266627|NCT00386100|Secondary|Number of Participants Achieving Treatment Failure|Treatment failure was defined as an HbA1c level >= 7% after Week 32 or withdrawal due to insufficient therapeutic effect (ITE) at any time.|Randomization to treatment failure (up to Week 80)|ITT Population. Only evaluable participants, defined as the number of subjects with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis|||participants|||Number
1266743|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Heart Rate|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||beats per minute||Standard Error|Least Squares Mean
1266629|NCT00386100|Secondary|Change From Baseline in FPG at Week 80|Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values.|Baseline and Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||mmol/l||Standard Deviation|Mean
1266630|NCT00386100|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80|Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value.|Baseline and Week 80|ITT Population. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis.|||millimoles per Liter (mmol/l)||Standard Error|Mean
1266631|NCT00386100|Secondary|Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80|Blood was taken for serum Hb1AC measurements. Hb1AC responders were described as participants having achieved Hb1AC <=6% and <7% at Week 80 with LOCF from Week 32.|Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||participants|||Number
1266632|NCT00386100|Primary|Change From Baseline in HbA1c at Week 80|Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis.|Baseline and Week 80|Intent-to-Treat (ITT) Population: all participants who were randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed.|||percent change||Standard Error|Mean
1266633|NCT00386100|Secondary|Mean Change From Baseline in HbA1c at Week 80|Blood was taken for serum Hb1AC measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values.|Baseline and Week 80|Week 32 Evaluable Population with LOCF: a subset of the ITT Population with LOCF starting at Week 32. Only participants with assessment(s) at Week 32 or later were included in this population. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change||Standard Deviation|Mean
1266634|NCT00386022|Primary|Effect of Estrogen on Pituitary Response to GnRH|LH and FSH responses to each of 4 GnRH doses, expressed as change in amplitude [amp] from peak to nadir between plus estrogen and baseline conditions|Peak hormone level within 2 hours post GnRH doses||||IU/L||Standard Error|Mean
1266635|NCT00386022|Primary|Pituitary Response to GnRH|Baseline LH and FSH responses to each of 4 GnRH doses - peak to nadir amplitude expressed as percent (%) change from nadir|Peak hormone level within 2 hours post GnRH doses||||Percent change||Standard Error|Mean
1266636|NCT00386009|Secondary|Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests|Laboratory tests that were statistically significant and clinically adverse would be reported for safety.|Baseline and 12 weeks|All randomized participants.|||significant and clinically adverse labs|||Number
1266637|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||units on a scale||Standard Deviation|Mean
1266638|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction|Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.|Baseline and 12 weeks|Number of participants in the Primary Analysis Population with involuntary detrusor contractions during bladder filling at both baseline and endpoint.|||milliliters||Standard Deviation|Mean
1266639|NCT00386009|Secondary|Presence of Involuntary Detrusor Contractions During Bladder Filling||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||participants|||Number
1266640|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies|BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||units on a nomogram||Standard Deviation|Mean
1266641|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies|BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||units on a nomogram||Standard Deviation|Mean
1266642|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies|Max Pdet was defined as the maximum detrusor pressure observed during voiding.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||centimeters of water (cm H20)||Standard Deviation|Mean
1266643|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies|Vcomp was defined as the volume of voided urine measured during pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
1266644|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies|Qave was measured during pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters per second||Standard Deviation|Mean
1266645|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies|Qmax was measured duirng pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters per second||Standard Deviation|Mean
1266646|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies|Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
1266647|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies|Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
1266648|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies|PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
1266649|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
1266650|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies|Qave was measured during free-flow tests using a standard calibrated flow meter.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||millilters per second||Standard Deviation|Mean
1266651|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies|Qmax was measured during free-flow tests using a standard calibrated flow meter.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters per second||Standard Deviation|Mean
1266652|NCT00386009|Primary|Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||centimeters of water (cm H20)||Standard Deviation|Mean
1266653|NCT00385996|Secondary|Disease-free Survival (DFS)|Defined as the time from the start of treatment to the time of recurrent disease in the primary or in metastatic sites.|From date of erlotinib start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 25 months.||||Months||Inter-Quartile Range|Median
1266654|NCT00385996|Secondary|Time-to-progression (TTP)|Defined as the time from surgical resection to the time of recurrent disease in the primary or in metastatic sites.|Every 3 months for the first 6 months, then yearly for 2 years.||||Months||Inter-Quartile Range|Median
1266655|NCT00385996|Secondary|Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0.|"Safety will be measured by describing the incidence of AEs, including SAEs and discontinuation of study drug due to AEs, and incidence of abnormal clinical laboratory values from day 1 of treatment.~Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.~Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE."|From Day 1 until 30 days after the last study drug dose,|Per protocol|||Participants|||Count of Participants
1266674|NCT00385944|Primary|Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)|Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).|14 days after maintenance dose (MD)|The primary analysis was performed on the intent-to-treat (ITT) population, that is, all randomized subjects with a maintenance dose MPA measured for at least one of the treatments.|||Percentage aggregation||Standard Deviation|Mean
1266656|NCT00385996|Primary|Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.|High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.|High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.|Population per protocol|||Participants|||Count of Participants
1266657|NCT00385944|Secondary|Correlation of MPA to 20 μM ADP and PRU|Pearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU|Baseline through 29 days of treatment||||Correlation coefficient|||Number
1266658|NCT00385944|Secondary|Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)|Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise.|14 days after maintenance dose (MD)||||Participants|||Number
1266659|NCT00385944|Secondary|Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria|Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but <5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.|14 days after maintenance dose (MD)||||Participants|||Number
1266660|NCT00385944|Secondary|MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|14 days after the second maintenance dose (MD)|Subjects providing evaluable MPA to 20 μM ADP at Day 29.|||Percentage aggregation||Standard Deviation|Mean
1266661|NCT00385944|Secondary|MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|14 days after the first maintenance dose (MD)|Subjects providing evaluable MPA to 20 μM ADP at 14 days after the first maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
1266662|NCT00385944|Secondary|Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)||||Percentage aggregation||Standard Deviation|Mean
1266663|NCT00385944|Secondary|Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|Baseline to 6-18 hrs post loading dose (LD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage aggregation||Standard Deviation|Mean
1266664|NCT00385944|Secondary|Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)|Poor responder is defined as MPA to 20 μM ADP >75th percentile of the value at 6-18 hours post-clopidogrel LD.|14 days after maintenance dose (MD)||||Participants|||Number
1266665|NCT00385944|Secondary|P2Y12 Reaction Units (PRU)|P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition.|14 days after maintenance dose (MD)||||PRU||Standard Deviation|Mean
1266666|NCT00385944|Secondary|Platelet Reactivity Index (PRI)|"Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula:~PRI%=[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)]x100~Lower PRI% values indicate greater P2Y12 receptor blockade."|14 days after maintenance dose (MD)||||Percentage PRI||Standard Deviation|Mean
1266667|NCT00385944|Secondary|Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP|"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:~([RPA at baseline – RPA at time of postbaseline] / RPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage inhibition||Standard Deviation|Mean
1266668|NCT00385944|Secondary|Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP|"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:~([RPA at baseline – RPA at time of postbaseline] / RPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage inhibition||Standard Deviation|Mean
1266669|NCT00385944|Secondary|Inhibition Platelet Aggregation (IPA) to 5 μM ADP|"IPA is calculated as a percent decrease of MPA from baseline using the following formula:~([MPA at baseline – MPA at time of postbaseline] / MPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage inhibition||Standard Deviation|Mean
1266670|NCT00385944|Secondary|Inhibition Platelet Aggregation (IPA) to 20 μM ADP|"IPA is calculated as a percent decrease of MPA from baseline using the following formula:~([MPA at baseline – MPA at time of postbaseline] / MPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage inhibition||Standard Deviation|Mean
1266671|NCT00385944|Secondary|Mean Residual Platelet Aggregation (RPA) to 5 µM ADP|Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.|14 days after maintenance dose (MD)||||Percentage aggregation||Standard Deviation|Mean
1266672|NCT00385944|Secondary|Mean Residual Platelet Aggregation (RPA) to 20 µM ADP|Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.|14 days after maintenance dose (MD)||||Percentage aggregation||Standard Deviation|Mean
1266673|NCT00385944|Secondary|MPA to 5 μM ADP|Maximum platelet aggregation to 5 μM ADP was assessed by LTA.|14 days after maintenance dose (MD)||||Percentage aggregation||Standard Deviation|Mean
1266675|NCT00385918|Secondary|Step Activity Monitor|"The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment.~This measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months||||steps||Standard Deviation|Mean
1266676|NCT00385918|Secondary|10-meter Walk|"A functional capacity test to measure speed.~This measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching.~Note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months||||seconds||Standard Deviation|Mean
1266677|NCT00385918|Secondary|Six Minute Walk|"A functional capacity test to evaluate walking distance during a 6-minute time frame.~This measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured Baseline (Time point 0) and 3 months||||meters||Standard Deviation|Mean
1266678|NCT00385918|Secondary|Bone Mineral Content|"DXA assessment of bone mineral content.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months||||kg||Standard Deviation|Mean
1266679|NCT00385918|Secondary|Lean Muscle Mass|"DXA measurement of total lean muscle mass.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months||||kg||Standard Deviation|Mean
1266680|NCT00385918|Primary|Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.|"Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|0, 1.5 and 3, 4.5, and 6 months||||ml/kg/min||Standard Deviation|Mean
1266681|NCT00385918|Secondary|Percent Body Fat|"An assessment of percent body fat as determined by DXA analysis.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months||||percent of total mass||Standard Deviation|Mean
1266682|NCT00385918|Secondary|Body Mass|"DXA assessment of total body mass.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months||||kg||Standard Deviation|Mean
1266683|NCT00385918|Primary|Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments|"Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|0, 1.5 and 3, 4.5, and 6 months|A single outlier point in the baseline data in one control subject was noted. Laboratory journal notes for this subject indicated that this individual had far more episodes of robotic treadmill stops during his baseline testing due to a high degree of spasticity. Given this, we felt justified in excluding this outlier from further data analysis.|||ml/kg/min||Standard Deviation|Mean
1266684|NCT00385840|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.|||fold increase||95% Confidence Interval|Mean
1271394|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 4|Mean weekly evening peak expiratory flow at week 4, pre-dose|After 4 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
1266685|NCT00385840|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.|||subjects|||Number
1266686|NCT00385840|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.|||subjects|||Number
1266687|NCT00385840|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.|||titers||95% Confidence Interval|Geometric Mean
1266688|NCT00385840|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.|During the entire study period (from Day 0 to Day 29)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1266689|NCT00385840|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1266690|NCT00385840|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.|||subjects|||Number
1266691|NCT00385840|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.|||subjects|||Number
1266692|NCT00385827|Secondary|Overall Survival (OS)|The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date.|Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.|||days||95% Confidence Interval|Median
1266693|NCT00385827|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1266694|NCT00385827|Secondary|Number of Participants With Palliative Response|Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months up to 2 years|Data for this outcome measure was not analyzed because minimal efficacy analysis (primary and key secondary endpoints) was done due to early termination of study.||||||
1266741|NCT00385671|Secondary|Number of Participants With Treatment-emergent Elevated Blood Pressure|"Elevated systolic blood pressure: >=130 millimeter mercury (mm Hg) + an increase of >=10 mm Hg if baseline <130 mm Hg.~Elevated diastolic blood pressure: >=85 mm Hg + an increase of >=10 mm Hg if baseline <85 mm Hg."|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.|||participants|||Number
1266695|NCT00385827|Secondary|Time to Clinical Deterioration (TtCD)|The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.|||days||95% Confidence Interval|Median
1266696|NCT00385827|Primary|Part 2: Progression Free Survival (PFS)|The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first.|Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years|Intent-to-treat (ITT) population in Part 2 included all randomized participants.|||days||95% Confidence Interval|Median
1266697|NCT00385827|Primary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.|Baseline up to 12 weeks after last dose administration|Safety population in Part 1 included all participants who received at least one dose of study drug.|||participants|||Number
1266698|NCT00385801|Secondary|Amygdala Volume by MRI|Measure of Dispersion/Precision not calculated, and raw data are no longer available|12 weeks|Measure of Dispersion/Precision not calculated, and raw data are no longer available||||||
1266699|NCT00385801|Secondary|Cocaine Craving|The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week)|12 weeks|Mixed model repeated measures analysis of variance was performed.|||units on a scale||Standard Deviation|Mean
1266700|NCT00385801|Primary|Cocaine Use by Quantitative Urine Samples|After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below|12 weeks|Mean number of visits at which participants submitted urine samples with undetectable urine benzoylecgonine (UBE)|||visit with negative UBE||Standard Deviation|Mean
1266701|NCT00385801|Primary|Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues|Measure of Dispersion/Precision not calculated, and raw data are no longer available|12 weeks|Measure of Dispersion/Precision not calculated, and raw data are no longer available||||||
1266702|NCT00385788|Primary|Transplant Related Mortality Rate|Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.|Transplant to 100 days post transplant||||Participants|||Count of Participants
1266703|NCT00385762|Primary|Sperm Morphology|percent of sperm with normal shape|2 months post initial visit||||percent of sperm with normal shape||Standard Deviation|Mean
1266704|NCT00385762|Primary|Sperm Motility|percent of sperm with movement|2 months post initial visit||||Percent of sperm with movement||Standard Deviation|Mean
1266705|NCT00385762|Primary|Sperm Concentration|number of sperm per cubic centimeter of semen|2 months post initial visit||||number of sperm per cubic centimeter||Standard Deviation|Mean
1266706|NCT00385762|Primary|Semen Volume|measured in mL|2 months post initial visit||||mL||Standard Deviation|Mean
1266707|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 Among Participants Who Were Systemic Corticosteroid-free at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants enrolled under any version of the protocol who took systemic corticosteroids (CS) at Baseline, received at least 1 dose of study drug, and were systemic CS-free at Week 52 were included. Nonresponder imputation was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders post-escalation.|||Proportion of participants|||Number
1266708|NCT00385736|Secondary|Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 52|Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
1266742|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Body Weight|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||kilogram||Standard Error|Least Squares Mean
1267157|NCT00383019|Secondary|Number of Subjects With an IOP of <=17 mmHg at Week 8|Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
1266709|NCT00385736|Secondary|Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 52|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
1266710|NCT00385736|Secondary|Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 52|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
1266711|NCT00385736|Secondary|Proportion of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
1266712|NCT00385736|Secondary|Proportion of Participants With Clinical Response Per Partial Mayo Score at Week 52|"Clinical response per partial Mayo score is defined as a decrease in partial Mayo score of >= 2 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The partial Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; subjects who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
1266713|NCT00385736|Secondary|Proportion of Participants With Clinical Response Per Mayo Score at Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
1266714|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Partial Mayo Score at Week 52|"Clinical remission per partial Mayo score is defined as a partial Mayo score <= 2 and no individual subscore > 1.~The partial Mayo score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
1266715|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
1266716|NCT00385736|Secondary|Ranked Secondary Endpoint #12: Proportion of IBDQ Responders at Week 8 (Adalimumab 80/40 Versus Placebo).|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1267095|NCT00383266|Secondary|Time to Disease Progression|-Progressive disease=at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|Until patient progresses (median follow-up 293 days -- range (63-632 days)||||months||95% Confidence Interval|Median
1266717|NCT00385736|Secondary|Ranked Secondary Endpoint #11: Proportion of IBDQ Responders at Week 8 (Adalimumab 160/80/40 Versus Placebo).|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266718|NCT00385736|Secondary|Ranked Secondary Endpoint #10: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"Stool Frequency Subscore ranges from 0-3 as follows:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266719|NCT00385736|Secondary|Ranked Secondary Endpoint #9: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266720|NCT00385736|Secondary|Ranked Secondary Endpoint #8: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266721|NCT00385736|Secondary|Ranked Secondary Endpoint #7: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 80/40 Versus Placebo).|"Mucosal healing defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266722|NCT00385736|Secondary|Ranked Secondary Endpoint #6: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 80/40 Versus Placebo).|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266723|NCT00385736|Secondary|Ranked Secondary Endpoint #5: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266724|NCT00385736|Secondary|Ranked Secondary Endpoint #4: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266725|NCT00385736|Secondary|Ranked Secondary Endpoint #3: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266726|NCT00385736|Secondary|Ranked Secondary Endpoint #2: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266727|NCT00385736|Secondary|Ranked Secondary Endpoint #1: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266728|NCT00385736|Primary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 8|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
1266729|NCT00385723|Primary|ln(CES-D)|"log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|Baseline & 4 months|intention to treat|||scores on a scale||Standard Error|Least Squares Mean
1266730|NCT00385723|Primary|Serum ln(IL-6)|log-transformed serum Interleukin-6 (IL-6)|Baseline & 4 months|intention to treat|||pg/ml (raw IL-6)||Standard Error|Least Squares Mean
1266731|NCT00385723|Primary|Serum ln(TNF-a)|log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)|Baseline & 4 months|intention to treat|||pg/ml (raw TNF-a)||Standard Error|Least Squares Mean
1266732|NCT00385684|Secondary|Pain Assessment in Advanced Dementia (PAINAD)|Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort.|6 weeks||||units on a scale||Standard Deviation|Mean
1266733|NCT00385684|Primary|Pain Assessment in Advanced Dementia (PAINAD)|Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. Scale range is 0-10.|Two (2) weeks||||units on a scale||Standard Deviation|Mean
1266734|NCT00385671|Secondary|Number of Patients With Treatment-Emergent Elevated Laboratory Analytes|Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): >34, male (m): >36. Alanine Aminotransferase (ALT): f:<69 years (yr) >34, ≥69yr >32; m: <69yr >43, ≥69yr >35. Total Bilirubin (TBili): >21. Gamma Glutamyl Transferase (GGT): f: <59yr >49, ≥59yr >50; m: <59yr >61, ≥59yr >50. Fasting Plasma Glucose (FPG): <59yr >6.4, ≥59yr >6.7. Hemoglobin A1C (HbA1C) >6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr >106, 50-70yr >123, 70-80yr >164, ≥80yr >221; m: 18-50yr >129, 50-70yr >131, 70-80yr >156, ≥80yr >187|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.|||participants|||Number
1266735|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Hemoglobin A1C||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||percent||Standard Deviation|Mean
1266736|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||millimole/liter||Standard Deviation|Mean
1266737|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Total Bilirubin||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||micromole/liter||Standard Deviation|Mean
1266738|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels|Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units/liter||Standard Deviation|Mean
1266739|NCT00385671|Secondary|Number of Participants With Treatment-Emergent Changes in Body Weight|"Treatment-emergent high body weight: weight at last visit >=107% of baseline weight.~Treatment-emergent low body weight: weight at last visit <=93% of baseline weight."|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
1266740|NCT00385671|Secondary|Number of Participants With Treatment-Emergent Elevated Heart Rate|Elevated heart rate: >=100 beats per minute (bpm) + an increase of >=10 bpm if baseline <100 bpm.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.|||participants|||Number
1266744|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Blood Pressure|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||millimeter mercury||Standard Error|Least Squares Mean
1266745|NCT00385671|Secondary|Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure|Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs.|baseline through 12 weeks|All randomized patients.|||participants|||Number
1266746|NCT00385671|Secondary|Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for <56 contiguous days prior to randomization. Prior use: use of gabapentin for >=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks|Analyzed were all participants with a baseline and at least 1 non-missing post-baseline value. Last observation carried forward analysis.|||units on a scale||Standard Error|Least Squares Mean
1266747|NCT00385671|Secondary|Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)|Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site.|baseline, 12 weeks|The per-protocol sub-population of all randomized participants with a baseline value and >= 1 non-missing post-baseline value (modified intent-to-treat population) was included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266748|NCT00385671|Secondary|Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)|"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.~It was planned to analyze participants stratified by the presence or absence of a co-morbidity with GAD. However, due to the low number of participants with GAD in the study this analysis was not possible."|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266749|NCT00385671|Secondary|Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||days||95% Confidence Interval|Median
1266750|NCT00385671|Secondary|Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score|This is the number of days to first achieve an outcome using the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). Sustained response: ≥30% reduction, baseline to endpoint, with 30% reduction from baseline ≥2 weeks prior to endpoint, remaining at ≥20% reduction between. The median time to sustained response with some measure of dispersion could not be calculated for each treatment group.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||days||95% Confidence Interval|Median
1266751|NCT00385671|Secondary|Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days to first achieve ≥50% reduction, baseline to endpoint, in the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). The median time to first ≥50% reduction with some measure of dispersion could not be calculated for each treatment group. The number of patients who reached a ≥50% reduction in weekly mean 24 hour average pain score are presented in outcome measure 20.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||days||95% Confidence Interval|Median
1266752|NCT00385671|Secondary|Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||days||95% Confidence Interval|Median
1266753|NCT00385671|Secondary|Summary of Number of Participants Who Discontinued|Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
1267158|NCT00383019|Secondary|Number of Subjects With an IOP of <=16 mmHg at Week 8|Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
1266754|NCT00385671|Secondary|Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale|The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
1266755|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266756|NCT00385671|Secondary|Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms|Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||coefficient|||Number
1266757|NCT00385671|Secondary|Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores|The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
1266758|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores|The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266759|NCT00385671|Secondary|Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores|14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.|||participants|||Number
1266760|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores|14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266761|NCT00385671|Secondary|Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation||baseline through 12 weeks|All participants who were enrolled in the study.|||participants|||Number
1266762|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266799|NCT00385580|Secondary|Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP|BAP is a measure of bone metabolism. A decrease in BAP relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline BAP value >ULN and at least 1 on-study value.|||participants|||Number
1266763|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)|The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266764|NCT00385671|Secondary|Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
1266765|NCT00385671|Secondary|Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
1266766|NCT00385671|Secondary|Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
1266767|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266768|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266769|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266770|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266771|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266772|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1271395|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 16|Mean weekly morning peak expiratory flow at week 16, pre-dose|After 16 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
1266773|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266774|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266775|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266776|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266777|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 Weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266778|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266779|NCT00385671|Secondary|Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1266780|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266781|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266782|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266783|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266836|NCT00385515|Secondary|Number of Participants With Ulcerative Oral Mucositis|All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to identify recurrence of ulcerative oral mucositis.|At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle||||Participants|||Number
1266784|NCT00385671|Primary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1266785|NCT00385593|Secondary|Peak Expiratory Flow (PEF)|Peak expiratory flow (PEF)|6 months (end of the study)||||L/min||Full Range|Mean
1266786|NCT00385593|Secondary|Change in the Asthma Control Questionnaire(ACQ) Score|The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)|Daily 14 days prior to each of visit 2-4||||Scores on a scale||Full Range|Mean
1266787|NCT00385593|Secondary|Use of Inhaled Steroids|Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)|Baseline up to 6 months||||micrograms||Full Range|Mean
1266788|NCT00385593|Secondary|Mean Use of as Needed Medication|Mean use of as needed medication during the treatment period|Baseline up to 6 months||||Inhalations||Full Range|Mean
1266789|NCT00385593|Secondary|Total Number of Severe Exacerbations|Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.|Baseline up to 6 months||||Exacerbations|||Number
1266790|NCT00385593|Primary|Time to First Severe Asthma Exacerbation|Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.|Baseline up to 6 months||||Days||Standard Deviation|Mean
1266791|NCT00385580|Secondary|Mean Plasma Concentration at Dose 50 mg (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
1266792|NCT00385580|Secondary|Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
1266793|NCT00385580|Secondary|Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. In treatment group (100 mg, QD), no participant received a 70 mg at PK collection day.|||ng/mL||Standard Deviation|Mean
1266794|NCT00385580|Secondary|Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
1266795|NCT00385580|Secondary|Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
1266796|NCT00385580|Secondary|Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
1266797|NCT00385580|Secondary|Median Number of Months of BAP Response|The median number of months of the BAP response was calculated for participants with baseline BAP <= ULN, from first dose of dasatinib to the first time BAP is above ULN. For participants with baseline BAP > ULN, it was the time from BAP response to the first time BAP was above ULN. For participants with baseline BAP =< ULN or BAP, and no BAP above ULN, last BAP assessment date was used. The median number of months of response was not defined for participants with baseline value > ULN, that never achieved BAP response.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants who demonstrated a BAP response|||months||95% Confidence Interval|Median
1266798|NCT00385580|Secondary|Number of Participants With BAP Response|BAP is a measure of bone metabolism. A BAP response is calculated for participants with a baseline BAP value > ULN. It is defined as on-study BAP values within normal limits.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a baseline BAP value > ULN and at least 1 on-study value.|||participants|||Number
1268552|NCT00371787|Primary|Visual Acuity|level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.|baseline|Per Protocol. Only the data from participants who completed all study visits were analyzed.|||logMAR||Standard Deviation|Mean
1266800|NCT00385580|Secondary|Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP|BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline BAP value <=ULN and at least 1 on-study value.|||participants|||Number
1266801|NCT00385580|Secondary|Median Number of Months of uNTx Response|uNTx is a measure of bone metabolism.The median number of months of uNTx response was calculated for participants with baseline uNTx =< ULN and uNTx progression during treatment, from first dose of dasatinib to uNTx progression.For participant with baseline uNTx above ULN, it was time from uNTx response to uNTx progression.For participants with baseline uNTx equal to or below ULN or uNTx response and no uNTx progression, the date of last uNTx assessment was used. Duration of uNTx response was not defined for participants with baseline value greater than ULN who never achieved uNTx responses.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants who demonstrated a uNTx response.|||months||95% Confidence Interval|Median
1266802|NCT00385580|Secondary|Number of Participants With a uNTx Response|uNTx is a measure of bone metabolism. uNTx response is defined for participants with baseline uNTx above ULN. It is defined as either on-study uNTx values decreasing to within normal limits or 35% or more decrease in uNTx from baseline, whichever happens first.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a baseline uNTx value > ULN and at least 1 on-study value.|||participants|||Number
1266803|NCT00385580|Secondary|Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx|uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline uNTx value >ULN and at least 1 on-study value.|||participants|||Number
1266804|NCT00385580|Secondary|Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx|uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline uNTx value <=ULN and at least 1 on-study value.|||participants|||Number
1266805|NCT00385580|Secondary|Number of Participants With QTc Prolongation|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heart rate. A prolonged QT interval is a risk factor for ventricular tachyarrhythmias and sudden death.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.|||participants|||Number
1266806|NCT00385580|Secondary|Number of Participants With Positive Urinalysis|Participants' urine samples were tested for the presence of blood, glucose and protein. If these substances were present in a participant’s urine, the results were given as “positive”.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
1266807|NCT00385580|Secondary|Number of Participants With Abnormal Lactate Dehydrogenase (LD)|LDH is a laboratory safety parameter. Normal ranges for LD vary with both age and disease status, and another reason for variation in upper limit of normal (ULN) and lower limit of normal (LLN) is that LD was measured via a local (versus a standardized) laboratory. It is therefore not possible to provide one ULN and LLN for the population.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12, every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
1266808|NCT00385580|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous|Abnormalities were graded per the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-<2.0 mg/dL, Grade 4: <1.0 mg/dL; sodium: Grade 3: 120-<130 or >155-160mEq/L, Grade 4: <120 or >160 mEq/L; creatinine: Grade 3: >3.0-6.0 * ULN, Grade 4: >6.0 * ULN; potassium: Grade 3: 2.5 -<3.0 or >6.0 -7.0 mEq/L, Grade 4: < 2.5 or >7.0 mEq/L.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
1266809|NCT00385580|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: 5.0-20.0 * ULN (upper limit of normal), Grade 4: >20.0 * ULN; calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; bilirubin: Grade 3: >3-10 * ULN, Grade 4: >10 * ULN.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
1266810|NCT00385580|Secondary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities were graded per the NCI CTC, version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Platelets: Grade 3: 25.0 - <50.0*10^9/L, Grade 4: <25.0*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L. Leukocytes: Grade 3: 1.0 - <2.0*10^9/L, Grade 4: <1.0*10^9/L.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
1266811|NCT00385580|Secondary|Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs.|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy. Drug-related AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death. Participants who discontinued the study due to any drug-related AEs were also recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.|||participants|||Number
1266812|NCT00385580|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.|||participants|||Number
1266813|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 36|FAPSI-8:index of symptoms/concerns when assessing value of treatment for advanced prostate cancer.Participants respond to each item on 5-point Likert-type scale:0 (not at all) to 4 (very much).GP1:I have lack of energy,GP4:I have pain,GE6:I worry that my condition will get worse,C2:I am losing weight,P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do,P7:I have difficulty urinating,P8:My problems with urinating limit my activities. The number of participants for whom these data are available is too small for analysis.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants. The number of participants for whom this data are available is too small for analysis.||||||
1266814|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 24|FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||Units on a scale||Full Range|Median
1266815|NCT00385580|Secondary|Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36|The FAPSI-8 is a symptom index comprised of the most important clinician-rated symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. It includes 8 items developed to measure symptoms/concerns specific to prostate cancer such as fatigue, pain (3-items), weight loss, difficulty with urination (2-items) and concerns about the condition becoming worse. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much).|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||Units on a scale||Full Range|Median
1266816|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 12|FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||Units on a scale||Full Range|Median
1266817|NCT00385580|Secondary|Median Number of Months to Disease Progression|Measured from date of first dose to date of first 3 consecutive measurements that confirm PSA progression, date of disease progression,or death date.Disease progression:progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI),loss of PSA response or Investigator-defined clinical progression based on physical examination,history,symptoms,and ECOG-PS.For participants who did not progress or die,date of last PSA measurement or tumor assessment was used, whichever occurred first.|Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||months||95% Confidence Interval|Median
1266818|NCT00385580|Secondary|Number of Participants With Disease Progression|Disease progression: progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI), not as evaluated by bone scan (non-measurable lesions included visceral and bone lesions), loss of PSA response (only for participants who achieved a PSA response) or Investigator-defined clinical progression based on physical examination, history, symptoms, and ECOG-PS. For participants who did not progress or die, date of last PSA measurement or tumor assessment was used, whichever occurred first.|Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
1266819|NCT00385580|Secondary|Percentage of Participants With Confirmed Improved Bone Scan|An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|Participants with confirmed improved bone scan.|||Percentage of Participants|||Number
1266820|NCT00385580|Secondary|Number of Participants With a Confirmed Improved Bone Scan|An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.|||participants|||Number
1266837|NCT00385515|Primary|Duration of Ulcerative Oral Mucositis|All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis|At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle|Analysis only includes subjects randomized to the 30mg dose of SNX-1012|||Days||Standard Deviation|Mean
1269265|NCT00365976|Secondary|Patient Global Impression of Pain Ratings|Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)|postnaprosyn Baseline, Week 1, Week 2 week 4||||units on a scale||Standard Deviation|Mean
1266821|NCT00385580|Secondary|Number of Participants With CR, PR or SD|Disease control rate is defined as the number of participants whose best response was CR, PR or SD, per RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD; SD: neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; PD: defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.|||participants|||Number
1266822|NCT00385580|Secondary|Number of Participants With CR or PR|Tumor response was defined as the number of participants whose best response was CR or PR, per RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.|||participants|||Number
1266823|NCT00385580|Secondary|Number of Participants With Increase in PSA Doubling Time|PSA is a marker of prostate cancer. PSA doubling time is defined as log 2 divided by the slope of the log PSA line. An increase in PSA doubling time indicates improvement in anti-tumor activity.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements and positive log slope pre-treatment and on-study measurements.|||participants|||Number
1266824|NCT00385580|Secondary|Number of Participants With Decrease in PSA Log Slope|PSA is a marker of prostate cancer. A decrease in PSA value is an early indicator of potential anti-tumor activity. Log (PSA) is assumed to have a linear relationship with time. The PSA log slope is defined as the slope of the log PSA line.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.|||participants|||Number
1266825|NCT00385580|Secondary|Number of Participants With Decrease in PSA Velocity|PSA is a marker of prostate cancer. PSA velocity measures the rate of change of PSA values. A decrease in PSA values and hence PSA velocity is an early indicator of potential anti-tumor activity.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.|||participants|||Number
1266826|NCT00385580|Secondary|Number of Months of Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer. The duration of PSA response is measured from the time that the first of the 2 consecutive measurements met the criteria for confirmed PSA response, until the date of the first of the 3 consecutive measurements that confirm PSA progression, or the date of disease progression, or the date of death.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a decrease in PSA by at least 50% from baseline|||months|||Number
1266827|NCT00385580|Secondary|Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.|||Percentage of Participants|||Number
1266828|NCT00385580|Secondary|Number of Participants With a Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline, for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.|||participants|||Number
1266829|NCT00385580|Primary|Percentage of Participants With a Response|Response = confirmed PSA response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD [=>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on RECIST.|Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.|All treated participants.|||Percentage of Participants||95% Confidence Interval|Number
1266830|NCT00385580|Primary|Number of Participants With a Response|Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =>30% in sum of longest diameter [LD] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease [PD: =>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors [RECIST].|Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.|All treated participants.|||participants|||Number
1266831|NCT00385541|Secondary|Mean Score on the Ramsey Scale of Sedation|The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).|1 hour after surgery, 8 hours after surgery||||score on scale||Standard Deviation|Mean
1266832|NCT00385541|Secondary|The Number of Patients Who Vomited||1 hour after surgery, 8 hours after surgery||||participants|||Number
1266833|NCT00385541|Secondary|Pain Assessment by Patient|Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.|1 hour after surgery, 8 hours after surgery||||Units on a scale||Standard Deviation|Mean
1266834|NCT00385541|Secondary|Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale|The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).|1 hour after surgery, 8 hours after surgery||||Units on a scale||Standard Deviation|Mean
1266835|NCT00385541|Primary|Nausea Assessment by Patient|Nausea scale range: (0 = none, 10 = the worst), ordinal.|1 hour after surgery, 8 hours after surgery|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1266838|NCT00385268|Primary|Urine Benzoylecgonine Tests (UBT)|The primary outcome measure for this trial was qualitative urine benzoylecgonine tests (UBT) obtained twice weekly. Urine collection was monitored by temperature checks. Samples less than 90 degrees, or greater than 100 degrees Fahrenheit were considered invalid and were not accepted. Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive.|8 weeks||||% of negative UBT|||Number
1266839|NCT00385268|Primary|Cocaine Use as Measured by Self Report on the Time-Line Follow Back and Confirmed With Urine Drug Screen.||8 weeks|||||||
1266840|NCT00385255|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the whole study period (from Day 0 to Month 2)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1266841|NCT00385255|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day period (Day 0-30) following each vaccination, up to 2 months|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1266842|NCT00385255|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain, muscle aches and shivering. Any = occurrence of the symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0.|During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
1266843|NCT00385255|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0.|During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
1266844|NCT00385255|Secondary|Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers|Anti-H1N1, anti-H3N2 and anti-B antibody titers are presented as geometric mean titers (GMTs).|At Month 1 post-Fluarix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1266845|NCT00385255|Secondary|Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens|Booster responses for anti-PT, anti-FHA and anti-PRN are defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL), one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with Boostrix®.|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1266846|NCT00385255|Secondary|Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens|Booster responses for anti-D and anti-T antibodies are defined as: For initially seronegative subjects [pre-vaccination concentration below (<) cut-off 0.1 IU/mL]: antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL), one month after vaccination with Boostrix®; For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with Boostrix®.|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1266847|NCT00385255|Secondary|Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN)|Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Day 0 and Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1266848|NCT00385255|Secondary|Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T)|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL).|At Day 0 and Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1266849|NCT00385255|Secondary|Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value|A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL.|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1266850|NCT00385255|Primary|Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B|Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer.|At Month 1 post-Fluarix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1266851|NCT00385255|Primary|Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza|The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.|At Month 1 post-Fluarix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1266852|NCT00385255|Primary|Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens|Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1266853|NCT00385255|Primary|Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value|The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1266854|NCT00385255|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively.|At Month 1 post-Boostrix® vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1266855|NCT00385216|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|5 days||||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1266856|NCT00385216|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|5 days||||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1266857|NCT00385216|Secondary|Heart Rate|Heart rate reported in beats per minute (BPM)|5 days||||Beats per minute (BPM)||Standard Deviation|Mean
1266858|NCT00385216|Secondary|hydrocodone5 mg/Acetaminopgen 325 mg Use||5 days|||||||
1266859|NCT00385216|Secondary|Nausea||5 days|||||||
1266860|NCT00385216|Primary|Pain Reported by Patient|Pain reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.|1 day||||Numeric Rating Scale (NRS)||Standard Deviation|Mean
1266861|NCT00385203|Secondary|Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.|Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline.|CT assessments at Baseline and Week 16|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).|||cm3||95% Confidence Interval|Mean
1266862|NCT00385203|Secondary|Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.|Central review of CT images taking the total lesion volume at week 8 minus the total lesion volume at baseline.|CT assessments at Baseline and Week 8|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).|||cm3||95% Confidence Interval|Mean
1266863|NCT00385203|Secondary|Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.|Central review of CT images taking the longest diameter measured in millimetres at week 16 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.|CT assessments at Baseline and Week 16.|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).|||mm||95% Confidence Interval|Mean
1266864|NCT00385203|Secondary|-Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.|Central review of CT images taking the longest diameter measured in millimetres at week 8 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.|CT assessments at Baseline and Week 8|As per the protocol the formal statistical analysis was performed for the GIST grouppatients only, STS patients were summarised (not STS patients). For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).|||mm||95% Confidence Interval|Mean
1266865|NCT00385203|Secondary|Objective Tumour Response, Investigator Review|Number of patients with complete (CR) /partial response (PR) (based on RECIST) as assessed by the Investigator. CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.|RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.||||Participants|||Number
1267112|NCT00383162|Secondary|Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of Participants with neck pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1266866|NCT00385203|Primary|Tumour Metabolic Activity as Assessed by Change in Central Review of Standardised Uptake Value (SUVMax) at Day 29, in Patients With GIST Tumours. SUVmax at Day 29 Minus SUVmax at Baseline.|SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients|FDG-PET assessment at Baseline and 29 days after dosing.|As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 29).|||g/mL||95% Confidence Interval|Mean
1266867|NCT00385203|Primary|Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.|[F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET). Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours. SUVmax at Day 8 minus SUVmax at Baseline.|Baseline and 8 days after dosing.|As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 8).|||g/mL||95% Confidence Interval|Mean
1266868|NCT00385138|Secondary|Incidence of Stroke|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
1266869|NCT00385138|Secondary|Incidence of Stent Thrombosis|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
1266870|NCT00385138|Secondary|Incidence of IDR|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
1266871|NCT00385138|Secondary|Incidence of MI|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
1266872|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
1266873|NCT00385138|Secondary|Incidence of All-cause Mortality or MI|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
1266874|NCT00385138|Secondary|Incidence of All-cause Mortality, MI, or IDR|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
1266875|NCT00385138|Secondary|Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm|Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm.|randomization through 48 hours post randomization|Safety population|||participants|||Number
1266876|NCT00385138|Secondary|Incidence of ACUITY Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population|||participants|||Number
1266877|NCT00385138|Secondary|Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population|||participants|||Number
1266878|NCT00385138|Secondary|Incidence of GUSTO Severe / Life-threatening|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population|||participants|||Number
1266879|NCT00385138|Secondary|Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]|mITT population A patient could have multiple procedural events.|During index PCI|mITT population, based on available data|||participants|||Number
1266880|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 1 year post randomization|mITT population, based on available data|||participants|||Number
1266881|NCT00385138|Secondary|Incidence of Stroke|mITT|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
1266882|NCT00385138|Secondary|Incidence of Stent Thrombosis|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
1266883|NCT00385138|Secondary|Incidence of IDR|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
1266884|NCT00385138|Secondary|Incidence of MI|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
1266885|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
1266886|NCT00385138|Secondary|Incidence of All-cause Mortality or MI|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
1266887|NCT00385138|Primary|Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)|mITT population; (composite incidence)|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
1266888|NCT00385008|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Day 30|The Safety Population consisted of all participants who were randomized and received at least one dose of study medication.|||Participants|||Count of Participants
1266911|NCT00384930|Secondary|"Number of Participants Who Answer Yes to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)"|LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||participants|||Number
1267155|NCT00383019|Secondary|Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8|Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
1266889|NCT00385008|Primary|Small Intestine Transit and Residence (Time to 50% Through Intestine) of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan|Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant’s chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).|Day 1 of each treatment administered (For 30 days)|Scintigraphy Population|||hr||Full Range|Median
1266890|NCT00385008|Primary|Time to First Appearance of Sumatriptan, Naproxen and Eletriptan at the Proximal Small Intestine|Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant’s chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).|Day 1 of each treatment administered (For 30 days)|Scintigraphy Population|||hr||Full Range|Median
1266891|NCT00385008|Primary|Time to Complete Dispersion of the Sumatriptan and Naproxen Portions of the TREXIMA Tablet and of the Relpax Tablet|Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant’s chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).|Day 1 of each treatment administered (For 30 days)|Scintigraphy Population|||hr||Full Range|Median
1266892|NCT00385008|Primary|Tmax for Eletriptan|Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.|PK parameter Population|||hr||Full Range|Median
1266893|NCT00385008|Primary|Time of Maximal Drug Concentration (Tmax) for Sumatriptan and Naproxen|Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.|PK parameter Population|||hr||Full Range|Median
1266894|NCT00385008|Primary|Cmax for Eletriptan|Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.|PK parameter Population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1266895|NCT00385008|Primary|Maximum Observed Drug Concentration (Cmax) for Sumatriptan and Naproxen|Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.|The PK parameter Population|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1266896|NCT00385008|Primary|Mean AUC (0-inf) and AUC (0-2) for Eletriptan|Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.|The PK parameter Population. Only those participants available at the specified time points were analyzed.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1266930|NCT00384813|Primary|Metered Dose Inhaler Checklist (MDIC)|Observational rating scale assessing MDI/spacer technique|4 months, 10 months|||||||
1269371|NCT00365209|Secondary|Number of Participants at Each Adverse Event Grade Level||Baseline to 30 days|These participants completed the study. The data is from the final dataset which was available in 2013 following the publication.|||participants|||Number
1266897|NCT00385008|Primary|Mean Area Under the Drug Concentration Time Curve (AUC) From Time of Dosing Through 2 Hour Post-dose [AUC (0-2)], Through 24 Hour [AUC (0-24)] and AUC From Time of Dosing Extrapolated to Infinity [AUC (0-inf)] for Sumatriptan and Naproxen|Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.|"PK parameter population comprised of all participants in the PK concentration population for whom PK parameters were calculated.~PK concentration population comprised of all participants who had a sample obtained and analyzed. Only those participants available at the specified time points were analyzed."|||microgram*hr per mL (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1266898|NCT00385008|Primary|Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan|Scintigraphic images were analyzed in a time-lapse format and regions of interest were drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with pharmacokinetic (PK) blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant’s chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).|Day 1 of each treatment administration (For 30 days)|Scintigraphy Population consisted of all participants with evaluable data from the scintigraphic images.|||hours (hr)||Full Range|Median
1266899|NCT00384956|Post-Hoc|Progression-free Survival (PFS)|"PFS is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.~Disease progression~for patients w/ <5% blasts; a ≥50% increase in blasts to >5% blasts~for patients w/ 5% to 10% blasts; a ≥50 increase to >10% blasts~for patients w/ 10% to 20% blasts; a ≥50% increase to >20% blasts~for patients w/ 20% to 30% blasts; a ≥50% increase to >30% blasts~One or more of the following ≥50% decrement from maximum remission/response levels in granulocytes or platelets, reduction in hemoglobin concentration by ≥2 g/dL or transfusion dependence"|2 years after first dose of study drug or until participant is lost to follow-up or dies||||days||Full Range|Median
1266900|NCT00384956|Post-Hoc|Duration of Response (DOR)||2 years after first dose of study drug or until participant is lost to follow-up or dies||||days||Full Range|Median
1266901|NCT00384956|Secondary|Rate of Relapse After Hematopoietic Stem Cell Transplant in Individuals Treated With 5-azacitidine Prior to Transplant.||2 years after first dose of study drug or until participant is lost to follow-up or dies|This secondary outcome was not analyzed.||||||
1266902|NCT00384956|Secondary|Rate of Overall Survival|Overall survival is defined as the date of first dose of study drug to the date of death from any cause.|2 years after first dose of study drug or until participant is lost to follow-up or dies||||days||Full Range|Median
1266903|NCT00384956|Secondary|Rate of Cytogenetic Response||2 years after first dose of study drug or until participant is lost to follow-up or dies|This secondary outcome was not analyzed.||||||
1266904|NCT00384956|Post-Hoc|Time to Best Response||4 weeks following last dose of azacitidine [median number of cycles 4.5 (1-20)]||||days||Full Range|Median
1266905|NCT00384956|Secondary|Rate of Transfusion Independence||4 weeks following last azacitidine dose [median number of cycles 4.5 (1-20)]|Only participants with baseline transfusion dependence were assessed for this outcome measure.|||participants|||Number
1266906|NCT00384956|Secondary|Rate of Hematologic Improvement|International Working Group (IWG) for Myelodysplasia (MDS).|4 weeks following last azacitidine dose [median number of cycles 4.5 (1-20)]||||participants|||Number
1266907|NCT00384956|Primary|Rate of Complete Remission (CR) and Partial Remission (PR)|"Defined according to the modified International Working Group (IWG) (2006) response criteria for myelodysplasia:~CR=bone marrow with <5% myeloblasts and 0% peripheral blasts, hemoglobin ≥11g/dL, platelets ≥ 100 x 10^9/L, and neutrophils ≥1.0 x 10^9/L. Residual dysplasia was allowed.~PR= All of the CR criteria if abnormal before treatment except: bone marrow blasts decreased by ≥50% over pretreatment but still >5%."|After 4 cycles of therapy (up to 112 days after start of treatment)||||participants|||Number
1266908|NCT00384930|Primary|Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis|Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.|Baseline and 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1266909|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain|Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from all randomized and sexually active subjects with a history of ED and non-missing data at baseline and at least one postbaseline visit were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1266910|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow|Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||milliliter per second||Standard Deviation|Mean
1266912|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)|Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1266913|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1266914|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)|Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1266915|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1266916|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore|Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1266917|NCT00384930|Primary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis|Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.|Baseline and 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1266918|NCT00384865|Secondary|Adverse Events|Please refer to the Adverse Event Tables for specific information|Measured at 6 months||||events|||Number
1266919|NCT00384865|Secondary|Time to Clinical Worsening Events (Number of Events)|Defined by the addition of new PAH therapies or dose increases in previously stable PAH therapy, hospitalization for right-sided heart failure, lung transplantation, atrial septostomy, and cardiovascular and all-cause death.|Measured at 6 months||||events|||Number
1266920|NCT00384865|Primary|Distance Walked in Six Minutes||Measured at 6 months||||meters||95% Confidence Interval|Least Squares Mean
1266921|NCT00384839|Secondary|Changes in Fetal Hemoglobin (HbF) With Time.|Time from baseline to maximal fetal hemoglobin (HbF).|Up to 1 year.|Patients with HbF measurements.|||weeks||Full Range|Median
1266922|NCT00384839|Secondary|1-year Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|Up to 1 year.|ITT population|||Probability of Survival at 1-year||95% Confidence Interval|Number
1266923|NCT00384839|Secondary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 1.5 year.|ITT population|||weeks||Full Range|Median
1266924|NCT00384839|Secondary|Objective Response Rate by Recist (ORR)|ORR = Complete Response (CR) + Parcial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Every 8 weeks for 1 year.|Only for patients with lesions evaluable by RECIST criteria at baseline.|||percentage of participants||95% Confidence Interval|Number
1266925|NCT00384839|Secondary|PSA Response Rate|Complete PSA Response defined as complete normalization of PSA maintained for at least 4 weeks, and partial PSA response defined as a decrease in PSA level of at least 50% from baseline level maintained for at least 4 weeks.|Every 8 weeks for 1 year.|Evaluable population|||percentage of participants||95% Confidence Interval|Number
1266926|NCT00384839|Primary|Percentage of Patients With PSA Doubling Time >=3 Months.|To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time >3= months.|Until progression or up to a maximum of 12 cycles|Evaluable population|||% of patients with PSA-DT>= 3 months||95% Confidence Interval|Number
1266927|NCT00384813|Secondary|Brief Symptom Inventory (BSI)||4 months, 10 months|||||||
1266928|NCT00384813|Secondary|Parenting Stress Index - SF (PSI-SF)||4 months, 10 months|||||||
1266929|NCT00384813|Primary|Asthma Morbidity, as Determined by Number of Asthma Symptom Days, Number of School Days Missed Due to Asthma, and Number of Emergency Department Visits for Acute Asthma||4 months, 10 months|||||||
1266931|NCT00384813|Primary|Mean Score on the Family Asthma Management System Scale (FAMSS)|Family Asthma Management System Scale is semi-structured clinical interview that includes open-ended questions assessing family management of pediatric asthma. The interview is recorded and rated using a standard manual on seven core subscales and two optional subscales.The interview is recorded and rated on seven to nine 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management (1 being the worse asthma management and 9 being the best asthma management). Mean of all of the subscales used to compute a total score.|4 months from baseline||||units on a scale||Standard Error|Mean
1266932|NCT00384748|Primary|Physical Function as Measured by Telephone Version of FIM|The FONEFIM was developed as a telephonic alternative and yields good concordance to the in-person, performance based FIM.12 The motor subscale of the FONEFIM (Motor FONEFIM) consists of 13 items encompassing four categories: 1) self-care; 2) sphincter control; 3) transfers; and 4) locomotion. Each item is scored on an ordinal scale from 1= total dependence to 7 = total independence. Possible scores range from 13 to 91, with higher scores indicating greater independence. The scoring considers the use of adaptive equipment and/or the extent of personal assistance or supervision required to complete the task.|6-month||||units on a scale||Standard Deviation|Mean
1266933|NCT00384670|Secondary|Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine.|Number of solicited general symptoms within the 7-day follow-up after the second dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)|Approximately Day 225 and Day 255||||Number of solicited general symptoms|||Number
1266934|NCT00384670|Secondary|Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine.|Number of solicited general symptoms within the 7-day follow-up after the first dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)|Approximately Day 225 and Day 255||||adverse events|||Number
1266935|NCT00384670|Secondary|Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.|Geometric mean titers (GMT) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to JE vaccine antibody titers.|Approximately Day 225 and Day 255|1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.|||titer||95% Confidence Interval|Geometric Mean
1266936|NCT00384670|Secondary|Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.|Percentage of individuals with ≥ 10 dilution (DIL) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to Japanese encephalitis (JE) vaccine antibody titers.|30 days after the second dose of JE vaccine|1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.|||percentage of participants||95% Confidence Interval|Number
1266937|NCT00384670|Secondary|Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine|Number of solicited general symptoms within the 21-day follow-up of dengue dose 2 vaccine dose (total vaccinated cohort)|21 Days (0-20) After the Second Dose of Dengue Vaccine||||adverse events|||Number
1266938|NCT00384670|Secondary|Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine|Number of subjects with unsolicited symptoms classified by MedDRA Primary System Organ Class and Preferred Term, within 30 days after dengue vaccine (total vaccinated cohort)|30 days||||adverse events|||Number
1266939|NCT00384670|Primary|Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine.|Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).|21 days||||adverse events|||Number
1266940|NCT00384397|Secondary|Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination|Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.|0-7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Percentage of Participants|||Number
1266941|NCT00384397|Other Pre-specified|Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.||30 days post-Visit 2 Menactra®|Geometric mean titers and their 95% Confidence Intervals, measured by SBA-HC, were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1266942|NCT00384397|Other Pre-specified|Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)||30 days post-Visit 2 Menactra®|Antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
1266943|NCT00384397|Primary|Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)||30 days post-visit 2 Menactra®|Antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
1266944|NCT00384332|Secondary|Change From Baseline Montgomery Asberg Depression Rating Scale|Montgomery Asberg Depression Rating Scale (MADRS) total score. Construct: Depression severity. Scores below represent mean change scores, endpoint minus baseline. Minimum total score: 0 (no depression). Maximum total score: 60 (severe depression). Lower (more negative) scores indicate a better outcome. There are no subscales.|10 weeks|Patients with bipolar disorder randomized to orally disintegrating versus regular olanzapine.|||units on a scale||Standard Deviation|Mean
1266945|NCT00384332|Primary|Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8|Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8|10 weeks||||kilograms||Standard Error|Mean
1266946|NCT00384293|Secondary|Change in Lipid Profile||after 96 weeks of postrandomization treatment|study prematurely terminated, no efficacy analyses were performed||||||
1266947|NCT00384293|Primary|Change in Mean Carotid Intima Media Thickness|change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.|after 96 weeks of postrandomization treatment|study prematurely terminated, no efficacy analyses were performed||||||
1266948|NCT00384241|Secondary|The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure|Stress induced systolic blood pressure (SBP) data generated from two previous studies was collected. In the previous studies, systolic blood pressures were measured before and after completing a video game challenge. Stress induced SBP is defined as delta SBP = stress SBP - baseline SBP.|baseline and 4 hours|All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.|||mmHg||Standard Deviation|Mean
1266949|NCT00384241|Primary|Change in Urinary Sodium Excretion (UNaV)|The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.|Baseline and 4 hour|All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.|||pg/ml||Standard Deviation|Mean
1266950|NCT00384189|Secondary|Change From Baseline in Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall|PACQLQ assesses the impact of the child’s asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
1266951|NCT00384189|Secondary|Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score|PAQLQS is a disease specific instrument to assess the impact of asthma on the patient’s quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
1266952|NCT00384189|Secondary|Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF|Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF. The median percentage of days with asthma control is presented.|28 days prior to last visit (Up to 12 Weeks)|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||percentage of days||Full Range|Median
1266953|NCT00384189|Secondary|Change in Use of Rescue Medications|The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.|||puffs/day||Standard Deviation|Mean
1266954|NCT00384189|Secondary|Change in Asthma Symptom Total Score|Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0(best) to 4 (worst). A negative change from Baseline indicated improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.|||score on a scale||Standard Deviation|Mean
1266955|NCT00384189|Secondary|Change From Baseline in Diurnal PEF Fluctuations|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||percent change||Standard Deviation|Mean
1266956|NCT00384189|Secondary|Change From Baseline in Evening PEF From Diary|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.|||liters/minute||Standard Error|Least Squares Mean
1266967|NCT00384176|Secondary|Overall Survival|Number of months from randomisation to the date of death from any cause|Randomisation until data cut-off|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
1266957|NCT00384189|Secondary|Change From Baseline in Morning PEF From Diary|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Weeks 1 thru 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||liters/minute||Standard Error|Least Squares Mean
1266958|NCT00384189|Secondary|Change From Baseline in Lung Function Variable PEF by Spirometry|Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.|||liters/minute||Standard Error|Least Squares Mean
1266959|NCT00384189|Secondary|Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)|Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||liters||Standard Error|Least Squares Mean
1266960|NCT00384189|Secondary|Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation|Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented.|28 days prior to last visit (Up to 12 Weeks)|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||percentage of days||Full Range|Median
1266961|NCT00384189|Secondary|Time to First Event of Lack of Efficacy (LOE) by Week 12|Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period.|12 weeks|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||Percent|||Number
1266962|NCT00384189|Primary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||liters/minute||Standard Error|Least Squares Mean
1266963|NCT00384176|Secondary|Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)|Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.|Baseline through to data cut-off||||Days||Inter-Quartile Range|Median
1266964|NCT00384176|Secondary|Percentage Change in Tumour Size|Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100|Baseline to Week 8|No statistical analyses were performed on the 30mg group. Patients had to have both a baseline and post-baseline (week 8) value to be included in the analysis. If patients did not have a week 8 assessment they were not included.|||Percentage change in tumour size||Standard Deviation|Mean
1266965|NCT00384176|Secondary|Duration of Response|Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.|Up until data cut-off date of 15/11/2007|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
1266966|NCT00384176|Secondary|Objective Response Rate|"Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:~CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs."|Up until data cut-off|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.|||Participants|||Number
1267062|NCT00383552|Secondary|Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12|Trough FEV1 is a measure of the end-of-dosing interval. The comparison was for MF/F vs F. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||liters||Standard Deviation|Least Squares Mean
1266968|NCT00384176|Primary|Progression Free Survival|Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
1266969|NCT00384085|Secondary|Adjusted Hypoglycemic Event Rates (Event/Patient-year)|"Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study.~An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to & including 1 day after the date of last dose of study drug)."|Week 60|The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site.|||event per patient year||Standard Error|Mean
1266970|NCT00384085|Secondary|Adjusted Incidence Rate of Hypoglycemia|"Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia.~A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) <36 mg/dL during or soon after the event.~A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion.~Nocturnal = events occurring between 00:00 & 06:00 based on a 24-hour clock.~An event is included if the HE start date is within the treatment period."|Week 60|The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site.|||estimated percentage per patient||Standard Error|Mean
1266971|NCT00384085|Secondary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl|"Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration.~A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of <50 mg/dL with reported symptoms."|At week 60|Analysis was performed on the mITT population. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3, 9 from Lantus/Apidra-1 & 7 from Novolog Mix arms) were excluded from this analysis.|||percentage of participants|||Number
1266972|NCT00384085|Secondary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)|Patients who achieved an HbA1c value <7.0% were defined as responders. Patients who did not achieve HbA1c values <7.0% and patients with missing HbA1c values were considered nonresponders.|At week 60|Analysis was performed on the modified intent-to-treat population which consisted of all patients who were randomized & for whom there was a baseline observation & at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (9 for Lantus/Apidra-1 & 7 for Novolog Mix arms) were excluded from this analysis.|||percentage of participants|||Number
1266973|NCT00384085|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)|Absolute Change in HbA1c from Baseline to Week 60.|From baseline to week 60|Analysis was performed on the modified ITT (mITT) population which consisted of all patients who were randomized, and for whom there was a baseline observation and at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3 & 7 from Novolog Mix arms) were excluded from this analysis.|||percent HbA1c||Standard Error|Least Squares Mean
1266974|NCT00384085|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis)|Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.|At week 60|Analysis was performed on the Intent To Treat (ITT) population which consisted of all patients who were randomized, and for whom there was any post-baseline follow-up information. Patients from non-GCP compliant sites were included in this analysis. This analysis was performed to ensure that study results were not compromised.|||percentage of participants|||Number
1266975|NCT00384085|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population|Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol.|At week 60|Analysis was performed on the Per Protocol (PP) population which included randomized patients who had no major protocol violation and who had HbA1c recorded for both Baseline & Week 60. Patients from non-GCP compliant sites were, by population definition, excluded from this analysis.|||percent HbA1c||Standard Error|Least Squares Mean
1266976|NCT00384085|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)|Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.|At week 60|Analysis was performed on Intent-To-Treat population which consisted of all patients who were randomized and for whom there was any post-baseline follow-up information. Patients from nonGCP compliant sites were excluded from this analysis. Additional analysis including those patients were completed to ensure that study results were not compromised.|||percentage of participants|||Number
1266977|NCT00384059|Secondary|Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N)= number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||titer||95% Confidence Interval|Geometric Mean
1266978|NCT00384059|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.|During the 4-day period after each dose|Safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
1266979|NCT00384059|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n)= number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
1266980|NCT00384059|Primary|Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.|Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented with corresponding 2-sided 95% CI.|one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1266981|NCT00384059|Primary|Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate igG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1266982|NCT00384059|Secondary|Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate antibody concentration/titer to the specific concomitant antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
1266983|NCT00384059|Primary|Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||EU/mL||95% Confidence Interval|Geometric Mean
1266984|NCT00384059|Primary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
1266985|NCT00384059|Primary|Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||titer||95% Confidence Interval|Geometric Mean
1266986|NCT00384059|Secondary|Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.|||Percentage of Participants||95% Confidence Interval|Number
1266987|NCT00384059|Secondary|Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.||one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.|||Percentage of Participants||95% Confidence Interval|Number
1267113|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Neck Pain|Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1266988|NCT00384059|Primary|Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.|Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.|One month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.|||Percentage of participants||95% Confidence Interval|Number
1266989|NCT00384033|Secondary|Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation|VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||mm||Standard Error|Mean
1266990|NCT00384033|Secondary|Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation|COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
1266991|NCT00384033|Secondary|Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation|HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
1266992|NCT00384033|Secondary|Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
1266993|NCT00384033|Secondary|Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation|Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
1266994|NCT00384033|Secondary|Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
1266995|NCT00384033|Secondary|Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
1266996|NCT00384033|Secondary|Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.|Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Participants|||Number
1267096|NCT00383266|Primary|Overall Response Rate (ORR)|"Overall response rate = complete response (CR) + partial response (PR) using RECIST.~CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level~PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)||||percentage of participants|||Number
1266997|NCT00384033|Primary|Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.|Baseline and Week 8 or FOT|Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
1266998|NCT00383942|Primary|Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor|The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.|At time of delivery|No participants are included in this analysis because the trial was terminated prematurely.||||||
1266999|NCT00383786|Secondary|Able to Identify Biological Markers That Predict Response to Treatment.||10 weeks|||||||
1267000|NCT00383786|Primary|Changes in CAPS Scores.|"The Clinician-Administered PTSD Scale (CAPS) is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. This is a 17-item core symptom scale, measuring both frequency and intensity of symptoms, with the most frequently used scoring rule is to count a symptom as present if it has a frequency of 1 or more and an intensity of 2 or more. A PTSD diagnosis is made if there is at least 1 B symptom, 3 C symptoms, and 2 D symptoms as well as meeting the other diagnostic criteria. Scores range from 0-136 0 (best possible outcome) to 136 (worst possible outcome). The relevant time-points for reporting change were at baseline and 8 weeks."|Baseline, 8 weeks|20 patients randomized to drug were included in the primary analysis as 2 our of the 22 randomized were excluded because they did not receive a week 1 assessment. 19/25 randomized to placebo were included in the analysis after 6 were excluded due to not receiving week 1 assessments.|||scores on a scale||Standard Deviation|Mean
1267001|NCT00383760|Secondary|Objective Stable Disease Rate|Objective stable disease rate Using RECIST|Upto 3 years|Data was not collected||||||
1267002|NCT00383760|Secondary|Toxicity|Types of Gr 3 or greater adverse events that are atleast possibly related to study drug|All patients will be evaluable for toxicity from the time of their first treatment with E7389.||||Types of adverse event|||Number
1267003|NCT00383760|Secondary|Response Duration||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years|Data were not collected||||||
1267004|NCT00383760|Secondary|Time to Progression|Estimated using the Kaplan-Meier method.|At 1 year|Time to progression at 1 year not analyzed||||||
1267005|NCT00383760|Secondary|Time to Progression|"Estimated using the Kaplan-Meier method.~Median time to progression"|At 6 months||||months||95% Confidence Interval|Median
1267006|NCT00383760|Secondary|Median Time to Disease Progression|Estimated using the Kaplan-Meier method.|Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years||||months||95% Confidence Interval|Median
1267007|NCT00383760|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|At 1 year||||participants|||Number
1267008|NCT00383760|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|At 6 months||||percentage of participants||95% Confidence Interval|Number
1267009|NCT00383760|Secondary|Median Survival Time|Estimated using the Kaplan-Meier method.|Up to 3 years||||months||95% Confidence Interval|Median
1267010|NCT00383760|Secondary|Stable Disease Rate, Evaluated Using RECIST Criteria|Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 3 years||||percentage of participants||95% Confidence Interval|Number
1267011|NCT00383760|Primary|Objective Response (Complete and Partial) Evaluated Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 3 years||||participants|||Number
1267012|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard|The Grooved Pegboard (model 32025 Lafayette Instrument Company, Lafayette, IN, USA). In this test of lateralized psychomotor speed, participants had 45 s to place as many pegs as possible into grooves on a board using their dominant hand. The number of correctly placed pegs were recorded for each of the two trials.It was measured 3 hrs after application of the patch after CPT, Stroop and Letter number sequencing|Visit 1 and visit 2 (separated by an interval of 7-10 days)||||number of pegs into grooves||Standard Deviation|Mean
1267013|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing|This measure of working memory and auditory attention was performed under two conditions. In the first condition, participants were read progressively longer lists of letters and numbers and instructed to repeat these exactly as given, without reordering. In the second condition, participants were read progressively longer lists of numbers and letters and instructed to re-order the list and give the numbers first in ascending order and then the letters in alphabetical order (WMS-III). The sum of the trial scores provided the item score and the sum of the item scores provided the total score.It was measured 3 hrs after application of the patch, after CPT and Stroop. The total score ranges from 0 to 21.Higher scores of Letter number sequencing means better working memory and auditory attention|Visit 1 and visit 2 (separated by an interval of 7-10 days)||||units on a scale||Standard Deviation|Mean
1267063|NCT00383552|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA)|Baseline is the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Endpoint|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||Proportion of Nights||Standard Deviation|Least Squares Mean
1267014|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Visual Attention and Cognitive Interference as Measured by Three Card Stroop|This standard test of visual attention, processing speed and cognitive interference was performed, in which three cards (Stoelting Co., Wood Dale, IL, USA) were presented in order: the first card with color names, the second with colored patches of ink and the third with color namesprinted in incongruously colored ink. Participants were asked to read or name as many colors as possible in 45 s for each condition. The raw interference score was calculated by subtracting the predicted color-word score (calculated using raw word and color scores) from the observed raw color-word score. This value was converted to an interference T score by referring to a standardized table. A higher interference T score indicates better task performance with less interference. It was measured 3 hrs after application of the patch, after CPT|Visit 1 and visit 2 (separated by an interval of 7-10 days)||||score||Standard Deviation|Mean
1267015|NCT00383747|Primary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version|The primary outcome measure was attention as measured by the Continuous Performance Test Identical Pairs (CPT-IP) Version 4.0 (Biobehavioral Technologies, New York, USA), developed for use in patients with schizophrenia and normal controls. In this task, participants were asked to respond when two identical pairs of numbers were presented in sequence by pressing a mouse key as quickly as possible using the dominant hand.The stimuli were presented with increasing cognitive load in successive blocks: two-,three- and four-digit target in the first, second and third block, respectively. Hit reaction time, a standard outcome variables on the CPTIP, is presented here. It was measured 3 hrs after application of the patch|Visit 1 and visit 2 (separated by an interval of 7-10 days)||||milliseconds||Standard Deviation|Mean
1267016|NCT00383721|Secondary|Number of Participants With Mild, Moderate, or Severe COPD Exacerbations|"Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more~nebulized treatments/day of inhaled rescue medication. Moderate = treatment with~antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event."|Endpoint (26 weeks)|ITT population|||Participants|||Number
1267017|NCT00383721|Secondary|Number of Participants With Partly Stable COPD|"Partly stable COPD was a composite measure that included the following COPD~outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly~average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or treatment-related adverse event as determined by the investigator."|Endpoint (26 weeks)|ITT population|||Participants|||Number
1267018|NCT00383721|Secondary|Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)|Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.|Baseline to Endpoint (26 weeks)|ITT population|||Proportion of symptom-free nights||Standard Deviation|Least Squares Mean
1267019|NCT00383721|Secondary|Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score|"SGRQ consisted of 76 items aggregated into 3 component scores: symptoms~(frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score ranged from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint was the last post-baseline non-missing result through the 26 week evaluation carried forward."|Baseline to Endpoint (26 weeks)|ITT population|||Score on a scale||Standard Deviation|Least Squares Mean
1267020|NCT00383721|Primary|Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1|Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|ITT population|||Liters||Standard Deviation|Least Squares Mean
1267021|NCT00383721|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|Intent-to-treat (ITT) population|||Liters||Standard Deviation|Least Squares Mean
1267022|NCT00383708|Secondary|Number of Subjects With Putative Antibodies to Lanreotide and to Pegvisomant During the Co-administration Period|Presence of putative antibodies to lanreotide and antibodies to pegvisomant were assessed prior to IMP administration at V2, V4 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The number of subjects with putative antibodies to lanreotide and to pegvisomant during the co-administration period (Baseline up to V11) is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant).|||Number of subjects|||Number
1267023|NCT00383708|Secondary|Change From Baseline in Prothrombin Time (Expressed as a Percentage of Normal) During the Co-administration Period|Blood samples for clinical laboratory tests were taken at V1, V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). During the co-administration period, hepatic toxicity was assessed at each visit (V5 to V10) by measuring ALT, AST, alkaline phosphatase, GGT, prothrombin time and total bilirubin. Prothrombin time was expressed as a percentage of the time taken for a control blood sample to clot (designated as 100%) and the mean change from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||percentage of time||Standard Deviation|Mean
1267151|NCT00383084|Primary|Ambulatory Fatigue, Higher Values Indicate Greater Fatigue|0-100 fatigue ratings, higher scores indicative of greater levels of fatigue|Baseline and after 12-weeks||||units on a scale||Standard Deviation|Mean
1267024|NCT00383708|Secondary|Change From Baseline in Total Bilirubin During the Co-administration Period|Blood samples for clinical laboratory tests were taken at V1, V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). During the co-administration period, hepatic toxicity was assessed at each visit (V5 to V10) by measuring ALT, AST, alkaline phosphatase, GGT, prothrombin time and total bilirubin. The change in mean total bilirubin from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||micromoles per litre||Standard Deviation|Mean
1267025|NCT00383708|Secondary|Change From Baseline in Liver Function Test Parameters During the Co-administration Period|Blood samples for clinical laboratory tests were taken at V1, V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). During the co-administration period, hepatic toxicity was assessed at each visit (V5 to V10) by measuring alanine amino transferase (ALT), aspartate amino transferase (AST), alkaline phosphatase, gamma glutamyl transferase (GGT), prothrombin time and total bilirubin. The change in mean ALT, AST, GGT and alkaline phosphatase from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in each individual analysis.|||IU/L||Standard Deviation|Mean
1267026|NCT00383708|Secondary|Change From Baseline in Mean Glycosylated Haemoglobin (HbA1C) During the Co-administration Period; Assessed in Non Diabetic and Diabetic Subjects|Glycosylated haemoglobin (HbA1C) was measured at V2, V3 and V11 (or in case of premature discontinuation, at the early withdrawal visit). The change in mean HbA1C in diabetic and non diabetic subjects from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis (56 overall for diabetic + non-diabetic subjects).|||percentage||Standard Deviation|Mean
1267027|NCT00383708|Secondary|Change From Baseline in Mean Fasting Insulin / Glucose Ratio During the Co-administration Period; Assessed in Non Diabetic Subjects|Glucose tolerance was only evaluated in non diabetic subjects. Glucose tolerance was assessed based on measurement of fasting blood glucose and insulin levels taken at V2 and OGTT performed at V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). A dose of 75 g oral glucose was given to subjects and blood samples then taken at 30, 60, 90 and 120 minutes after oral glucose to measure glucose, insulin and GH levels, and to evaluate the GH nadir level. The OGTT was performed after the assessment of IGF-1 and all safety laboratory tests, but before IMPs administration at V3. Glucose, insulin and GH levels were assessed before OGTT in fasting conditions and at the same time as IGF-1 assessment. The change in mean fasting insulin / glucose ratio from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Assessed in non diabetic subjects only (n = 38). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||ratio||Standard Deviation|Mean
1267028|NCT00383708|Secondary|Change From Baseline in Mean Fasting Glucose Concentration During the Co-administration Period; Assessed in Non Diabetic Subjects|Glucose tolerance was only evaluated in non diabetic subjects. Glucose tolerance was assessed based on measurement of fasting blood glucose and insulin levels taken at V2 and OGTT performed at V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). A dose of 75 g oral glucose was given to subjects and blood samples then taken at 30, 60, 90 and 120 minutes after oral glucose to measure glucose, insulin and GH levels, and to evaluate the GH nadir level. The OGTT was performed after the assessment of IGF-1 and all safety laboratory tests, but before IMPs administration at V3. Glucose, insulin and GH levels were assessed before OGTT in fasting conditions and at the same time as IGF-1 assessment. The change in mean fasting glucose concentration from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Assessed in non diabetic subjects only (n = 38). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||mmol/L||Standard Deviation|Mean
1267029|NCT00383708|Secondary|Change From Baseline in Mean Fasting Insulin Concentration During the Co-administration Period; Assessed in Non Diabetic Subjects|Glucose tolerance was only evaluated in non diabetic subjects. Glucose tolerance was assessed based on measurement of fasting blood glucose and insulin levels taken at V2 and OGTT performed at V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). A dose of 75 g oral glucose was given to subjects and blood samples then taken at 30, 60, 90 and 120 minutes after oral glucose to measure glucose, insulin and GH levels, and to evaluate the GH nadir level. The OGTT was performed after the assessment of IGF-1 and all safety laboratory tests, but before IMPs administration at V3. Glucose, insulin and GH levels were assessed before OGTT in fasting conditions and at the same time as IGF-1 assessment. The change in mean fasting insulin concentration from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Assessed in non diabetic subjects only (n = 38). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||picomoles per litre (pmol/L)||Standard Deviation|Mean
1267064|NCT00383552|Secondary|Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 26|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||units on a scale||Standard Deviation|Least Squares Mean
1267030|NCT00383708|Secondary|Change From Baseline in Mean Blood Glucose Maximum Concentration (Cmax) From Oral Glucose Tolerance Test (OGTT) During the Co-administration Period; Assessed in Non Diabetic Subjects|Glucose tolerance was only evaluated in non diabetic subjects. Glucose tolerance was assessed based on measurement of fasting blood glucose and insulin levels taken at V2 and OGTT performed at V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). A dose of 75 g oral glucose was given to subjects and blood samples then taken at 30, 60, 90 and 120 minutes after oral glucose to measure glucose, insulin and GH levels, and to evaluate the GH nadir level. The OGTT was performed after the assessment of IGF-1 and all safety laboratory tests, but before IMPs administration at V3. Glucose, insulin and GH levels were assessed before OGTT in fasting conditions and at the same time as IGF-1 assessment. The change in mean blood glucose Cmax (as determined from OGTT) from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Assessed in non diabetic subjects only (n = 38). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||millimoles per litre (mmol/L)||Standard Deviation|Mean
1267031|NCT00383708|Secondary|Change From Baseline in Mean Pituitary Tumour Size During the Co-administration Period|Pituitary tumour size was assessed by Magnetic Resonance Imaging at V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The two longest diameters of the pituitary tumour were to be measured. The change in mean pituitary tumour size from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||mm^3||Standard Deviation|Mean
1267032|NCT00383708|Secondary|Number of Subjects With Shift in Presence/Absence of Lithiasis and/or Sludge During Co-administration Period|A gallbladder ultrasound was performed at V2, V3, and V11 (or in case of premature study discontinuation, at the early withdrawal visit). Presence of lithiasis and sludge was recorded. Number of subjects who developed or resolved lithiasis and developed or resolved sludge, comparing Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant).|||participants|||Number
1267033|NCT00383708|Secondary|Change From Baseline in Mean PR Interval, QRS Interval, QT Interval, RR Interval and QTcF During the Co-administration Period|Twelve-lead ECG recordings were performed at V2, V3 and V11. Sinus rhythm, heart rate, PR interval, RR interval, QRS interval and QT interval were measured and QTcF was calculated. The change in mean ECG parameter for PR interval, QRS interval, QT interval, RR interval and QTcF from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in each individual analysis.|||milliseconds (ms)||Standard Deviation|Mean
1267034|NCT00383708|Secondary|Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate During the Co-administration Period|Twelve-lead ECG recordings were performed at V2, V3 and V11. Sinus rhythm, heart rate, PR interval, RR interval, QRS interval and QT interval were measured and heart rate corrected QT interval using the Fridericia method (QTcF) was calculated. The change in ECG mean heart rate from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of IMP drug during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||bpm||Standard Deviation|Mean
1267035|NCT00383708|Secondary|Change From Baseline in Mean Supine Heart Rate During the Co-administration Period|Heart rate (supine after resting for 3 minutes) was recorded at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The change in mean heart rate from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||beats per minute (bpm)||Standard Deviation|Mean
1267036|NCT00383708|Secondary|Change From Baseline in Mean Supine Systolic and Diastolic Blood Pressure (BP) During the Co-administration Period|Blood pressure (supine after resting for 3 minutes) was recorded at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The change in mean BP (systolic and diastolic) from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||millimetres mercury (mmHg)||Standard Deviation|Mean
1267037|NCT00383708|Secondary|Change From Baseline in Mean Weight From Baseline During the Co-administration Period|Weight was recorded at V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The change in mean weight from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||kilograms (kg)||Standard Deviation|Mean
1267065|NCT00383552|Primary|Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period|Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.|Across the 26 week treatment period|Medians for time-to-event outcomes are estimated for those who had events.|||Days||Inter-Quartile Range|Median
1267038|NCT00383708|Other Pre-specified|Change From Baseline in Prolactin Levels During the Co-administration Period|Serum samples were assessed for prolactin levels at V1, V2, V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). The change in mean prolactin levels from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||micrograms per litre (mcg/L)||Standard Deviation|Mean
1267039|NCT00383708|Other Pre-specified|Change From Baseline in Acid Labile Subunit Levels From Baseline During the Co-administration Period|Serum samples were assessed for acid labile subunit levels at V1, V2, V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). The change in mean acid labile subunit levels from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||milli IU per millilitre (mIU/mL)||Standard Deviation|Mean
1267040|NCT00383708|Other Pre-specified|Change From Baseline in Serum GH Binding Protein Levels During the Co-administration Period|Serum samples were assessed for GH binding protein levels at V1, V2, V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). The change in mean serum GH binding protein from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||pmol/L||Standard Deviation|Mean
1267041|NCT00383708|Other Pre-specified|Percentage of Subjects With Serum GH Levels Lesser or Equal to 2.5 ng/mL During the Study|Serum samples were assessed for GH levels at the same timepoints as the IGF-1 sample at V1 and V2 and during the OGTT (non diabetic subjects only) at V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). Five samples were taken over 2 hours in order to assess GH nadir and confirm the subject's eligibility before entering the co-administration period. For diabetic subjects, the OGTT was replaced by a measurement of GH level on a blood sample taken at the same time as IGF-1 at V3 and V11 (or at the early withdrawal visit). The percentage of subjects with serum GH levels ≤ 2.5 ng/mL at Baseline, V11 and LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||percentage of subjects|||Number
1267042|NCT00383708|Other Pre-specified|Change From Baseline in Serum GH Levels During the Co-administration Period|Serum samples were assessed for GH levels at the same timepoints as the IGF-1 sample at V1 and V2 and during the OGTT (non diabetic subjects only) at V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). Five samples were taken over 2 hours in order to assess GH nadir and confirm the subject's eligibility before entering the co-administration period. For diabetic subjects, the OGTT was replaced by a measurement of GH level on a blood sample taken at the same time as IGF-1 at V3 and V11 (or at the early withdrawal visit). The change in mean serum GH levels from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||nanograms per millilitre (ng/mL)||Standard Deviation|Mean
1267043|NCT00383708|Secondary|Correlation Between the Changes in ACROQoL Assessments With the Corresponding Changes in Z-score of IGF-1 Levels Over the Run-in Period and Co-administration Period|The correlation between the changes in ACROQoL (expressed as standardised scores and undertaken for global score, physical and psychological dimension scores and appearance and personal relationships sub-dimension scores) over the run-in period (V3 minus V2) and co-administration period (V11 and LVA minus V3) with the corresponding changes in z-score for the IGF-1 level is presented. A decrease in IGF-1 z-score represents an improvement and an increase in ACROQoL score represents an improvement. Spearman's rank correlation (r) values are presented for change from V2 to V3 (Baseline) and from Baseline to V11/LVA for each of the specified ACROQoL categories. Corr = Correlation; Dim = Dimension; Relnship = Relationship.|At V2 (Day 1; Run-in), V3 (Week 12; Baseline) and V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint.|||correlation value|||Number
1267044|NCT00383708|Secondary|Change From Baseline in Acromegaly Quality of Life (ACROQoL) Assessments During the Co-administration Period|The ACROQoL is a health-related quality of life (QoL) questionnaire for patients with acromegaly consisting of 22 items measured on a 5-point Likert-type scale that assesses frequency of occurrence (always to never) or degree of agreement (completely agree to completely disagree) with the statements. The ACROQoL consists of questions that evaluate physical (8 items) and psychological aspects related to appearance and personal relations (7 items each). Answers are transformed to a percentage value, where 100 is the maximal (best) and 0 the minimum (worse) score depicting self-perceived quality QoL. An increase in ACROQoL score is associated with an improved QoL. The change in ACROQoL global score, physical and psychological dimension scores and appearance and personal relationships sub-dimension scores from Baseline to V11 and to LVA are presented. Relnship = Relationship; Dim = Dimension.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||units on a scale||Standard Deviation|Mean
1267152|NCT00383084|Primary|Ambulatory Pain (Higher Values Indicate Greater Pain)|0 to 100 pain rating, higher numbers indicate greater pain|Baseline and after 12-weeks||||units on a scale||Standard Deviation|Mean
1267045|NCT00383708|Secondary|Change From Baseline in Acromegaly Symptoms During the Co-administration Period|Acromegaly symptoms, including arthralgia, excessive perspiration, fatigue, headache and soft tissue swelling were assessed with scores ranging from 0 (no symptoms) to 8 (severe, incapacitating symptoms). Symptoms were assessed by the subject in paper format before any other procedure planned during the visit. The change in acromegaly symptoms from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||units on a scale||Standard Deviation|Mean
1267046|NCT00383708|Secondary|Change From Baseline in Serum IGF-1 Levels (Expressed as Z-scores) During the Co-administration Period|The change in serum IGF-1 levels, expressed as z-scores calculated using the age and sex specific mean and standard deviation [SD] values from Baseline to V11 and to LVA are presented. A z-score between +/- 2 indicates a normal IGF-1 concentration.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||z-score||Standard Deviation|Mean
1267047|NCT00383708|Secondary|Percentage of Subjects With Normalised (Age and Sex Adjusted) IGF-1 at Each Assessment|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. The percentage of subjects with a normalised (age and sex adjusted) IGF-1 level is presented. The denominator used to calculate the percentages was the number of ITT population subjects with an assessment at the visit. In addition to the data for each individual visit, the last value available (LVA) data is also presented. None of the ITT population subjects had serum IGF-1 normalised at V3, consistent with the criterion to continue in the study and be treated in the co-administration period.|V1 (Screening) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||percentage of subjects|||Number
1267048|NCT00383708|Secondary|Percentage of Subjects With a Normalised (Age and Sex Adjusted) IGF-1 Level at Any Time During the Co-administration Period|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at least once during the co-administration period, summarised by ‘while taking the final dose during co-administration’ and ‘at any time during co-administration’ are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint.|||percentage of subjects|||Number
1267049|NCT00383708|Primary|Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Diabetic Status at Baseline|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period, summarised by diabetic status are presented. The denominator used to calculate percentages was the number of subjects in each subgroup (diabetic and non diabetic). The LOCF approach was used to replace missing IGF-1 values.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects within each of the two subgroups analysed for each category.|||percentage of subjects|||Number
1267050|NCT00383708|Primary|Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period, summarised by previous treatment and by final pegvisomant dose are presented. The denominator used to calculate percentages was the number of subjects in each subgroup, comprising previous treatment with pegvisomant, lanreotide Autogel and octreotide long acting repeatable (LAR) and final pegvisomant dose as either 40 mg, 60 mg or 80 mg once a week or 40 mg or 60 mg twice per week. The LOCF approach was used to replace missing IGF-1 values.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects within each individual subgroup analysed for each category.|||percentage of subjects|||Number
1267066|NCT00383552|Secondary|Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 26|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||units on a scale||Standard Deviation|Least Squares Mean
1267153|NCT00383071|Primary|Safety of H5N1 Vaccine as Measured by Adverse Events|The number of subjects experiencing adverse events after receiving H5N1 vaccine|Day 28, 56, 84|Primary outcome measure was safety, so below listed numbers are safety population used in AE list.|||participants|||Number
1267051|NCT00383708|Primary|Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at Visit (V) 1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to investigational medicinal product (IMP) administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period are presented. The last observation carried forward (LOCF) was used to replace missing IGF-1 values.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint.|||percentage of subjects|||Number
1267052|NCT00383643|Primary|Assessment of Sleepiness|Current self-report on Epworth Sleepiness Scale (ESS) at week 12 of intervention. This measure consists of 8 scenarios in which the participant is asked to assess how likely s/he is to fall asleep. Scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. Responses are summed for a total score ranging from 0 to 24. The higher the score, the greater the self-reported sleepiness. Scores of 9 and below are considered in the normal range.|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
1267053|NCT00383643|Primary|Assessment of Fatigue|Current self-report on Profile of Mood State -- Fatigue (POMS-F) at week 12 of intervention. This subscale of the POMS consists of 7 items each scored on a scale of 0 (not at all) to 4 (extremely) which are summed to provide a composite score of fatigue. The range is 0 to 28 for this subscale. Higher scores indicate more fatigue.|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
1267054|NCT00383643|Primary|Assessment of Pittsburgh Sleep Quality Index (PSQI)|"Current self-report on Pittsburgh Sleep Quality Index (PSQI) at week 12 of intervention. Consisting of 19 items, the PSQI measures several different aspects of sleep which can be combined into one global score.~Each item measure is scored on a scale of 0 to 3 where 3 is the extreme negative. The composite PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Based on this questionnaire, a composite score of 5 or greater is indicative of poor sleep quality."|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
1267055|NCT00383643|Primary|Assessment of Insomnia Severity Index|"Current self-report on Insomnia Severity Index at week 12 of treatment intervention. This is a seven-item questionnaire where the sum of the answers indicate the severity of insomnia. Total score categories:~0–7 = No clinically significant insomnia 8–14 = Subthreshold insomnia 15–21 = Clinical insomnia (moderate severity) 22–28 = Clinical insomnia (severe)"|12 weeks|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
1267056|NCT00383643|Primary|Assessment of Clinical Global Impression-change.|Clinician assessment of Clinical Global Impression-Change score at week 12 of treatment intervention. The Clinical Global Impression – Change scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the current time point. It is rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. One one clinician provided the ratings in this trial.|Baseline to week 12|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
1267057|NCT00383565|Secondary|Median Overall Survival|Survival time is defined as the time from registration to death due to any cause, measured in months. The distribution of survival time estimated using the method of Kaplan-Meier.|5 Years||||months||Full Range|Median
1267058|NCT00383565|Secondary|Median Progression Free-survival (PFS)|Time to disease progression is defined as the time from registration to documentation of disease progression.|2 Years||||months||Full Range|Median
1267059|NCT00383565|Primary|Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment|International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.|24 weeks (6 courses of 4 week cycles)||||participants|||Number
1267060|NCT00383552|Primary|Number of Participants With at Least One Severe Asthma Exacerbation at Week 26|Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.|Week 26||||participants|||Number
1267061|NCT00383552|Secondary|AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. BMI is a number calculated from a person's weight and height. The higher the number, the higher the amount of fat. The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||liters * hours||Standard Deviation|Least Squares Mean
1267094|NCT00383266|Secondary|Overall Survival Rate||1 year||||percentage of participants|||Number
1271396|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 12|Mean weekly morning peak expiratory flow at week 12, pre-dose|After 12 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
1267067|NCT00383552|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||liters * hours||Standard Deviation|Least Squares Mean
1267068|NCT00383500|Primary|Incidence of Lymphedema (Newly-developing)|Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.|3 years of semi-annual follow-up||||participants|||Number
1267069|NCT00383500|Primary|Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy|Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups|36 months|All enrolled patients in the trial who did not withdraw or were lost to follow-up|||participants|||Number
1267070|NCT00383435|Secondary|Number of Participants With Mild, Moderate, or Severe COPD Exacerbations|Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event.|Endpoint (26 weeks)|ITT population|||Participants|||Number
1267071|NCT00383435|Secondary|Number of Participants With Partly Stable COPD|"Partly stable COPD was a composite measure that included the following COPD~outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or~treatment-related adverse event as determined by the investigator."|Endpoint (26 weeks)|ITT population|||Participants|||Number
1267072|NCT00383435|Secondary|Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)|Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.|Baseline to Endpoint (26 weeks)|ITT population.|||Proportion of symptom-free nights||Standard Deviation|Least Squares Mean
1267073|NCT00383435|Secondary|Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score|SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score range from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint is the last post-baseline non-missing result through the 26 week evaluation carried forward.|Baseline to Endpoint (26 weeks)|ITT population|||Score on a scale||Standard Deviation|Least Squares Mean
1267074|NCT00383435|Primary|Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1|"Endpoint was the last post-baseline non-missing result through Week 13 carried~forward."|Baseline to Endpoint (13 weeks)|ITT population|||Liters||Standard Deviation|Least Squares Mean
1267075|NCT00383435|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|Intent-to-treat (ITT) population|||Liters||Standard Deviation|Least Squares Mean
1267076|NCT00383331|Secondary|Overall Survival|Survival time is defined as the time from date of randomization to death due to any cause.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
1267077|NCT00383331|Secondary|Time to Treatment Failure|Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
1267078|NCT00383331|Secondary|Duration of Response|Duration of response was not analyzed because the trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
1267079|NCT00383331|Secondary|Time to Progressive Disease|Time to progressive disease not analyzed because trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
1267080|NCT00383331|Secondary|Progression Free Survival|baseline to measured progressive disease|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
1267081|NCT00383331|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||participants|||Number
1267082|NCT00383292|Secondary|Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score|FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL.|Baseline to Study Completion (up to 60 Months)|All participants who received at least one dose of study drug and had baseline and post baseline FACT-G data. FACT-G analysis was performed on combined arms per protocol.|||Units on a Scale||Standard Deviation|Mean
1271397|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 8|Mean weekly morning peak expiratory flow at week 8, pre-dose|After 8 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
1267083|NCT00383292|Secondary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events)|Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.|Baseline to Study Completion (up to 60 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
1267084|NCT00383292|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year)|All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 6, Tasisulam Target Cmax 360 µg/mL = 5, Albumin-Tailored Dose = 5.|||Months||95% Confidence Interval|Median
1267085|NCT00383292|Secondary|Duration of Overall Objective Response|The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD.|Date of Response to Date of Measured PD (up to 1 Year)|All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 1, Tasisulam Target Cmax 360 µg/mL = 1, Albumin-Tailored Dose = 0.|||Months||95% Confidence Interval|Median
1267086|NCT00383292|Secondary|Overall Survival (OS) Time|OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.|Baseline to Death from Any Cause (up to 42 Months)|All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 25, Tasisulam Target Cmax 360 µg/mL = 17, Albumin-Tailored Dose = 17.|||Months||95% Confidence Interval|Median
1267087|NCT00383292|Secondary|Pharmacokinetics: Plasma Clearance Rate of Tasisulam||Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion|All participants who received at least one dose of study drug and had evaluable PK data. PK analysis were performed on combined arms for total drug per protocol.|||Liters/hour (L/h)||Standard Error|Geometric Mean
1267088|NCT00383292|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate)|Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam.|Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months)|All participants who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
1267089|NCT00383292|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months)|All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 10, Tasisulam Target Cmax 360 µg/mL = 8, Albumin-Tailored Dose = 8.|||Months||95% Confidence Interval|Median
1267090|NCT00383292|Primary|Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response)|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.|Baseline to Measured Progressive Disease (up to 60 Months)|All participants who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
1267091|NCT00383266|Secondary|Overall Survival (OS)|OS is defined as the time from initiation of treatment to the date of any reason death while those living subjects will be censored at the last assessment date.|Until patient's death (median follow-up 293 days -- range (63-632 days))||||months||95% Confidence Interval|Median
1267092|NCT00383266|Secondary|Overall Survival Rate||2 years||||percentage of participants|||Number
1267093|NCT00383266|Secondary|Toxicities||30 days following completion of treatment (maximum number of cycles = 6)||||participants|||Number
1267097|NCT00383240|Other Pre-specified|Number of Participants With at Least One Severe Asthma Exacerbation|"A severe asthma exacerbation was defined as a clinically judged deterioration of asthma or a meaningful reduction in lung function based on any of the following criteria during the Treatment Period:~A decrease in FEV1 below the Treatment Period stability limit at any visit,~A decrease in AM or PM peak flow below the Treatment Period stability limits on any 2 consecutive days,~An occurrence of any clinical deterioration of asthma (ie, asthma attack) that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication."|Baseline to Week 26|All Randomized Subjects|||participants|||Number
1267098|NCT00383240|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)|Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled.|Baseline to Endpoint|ITT population from the entire 26-week treatment period|||Ratio||Standard Deviation|Least Squares Mean
1267099|NCT00383240|Secondary|Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case).|Baseline to week 26|ITT population with non-missing post-baseline ACQ result|||units on a scale||Standard Deviation|Least Squares Mean
1267100|NCT00383240|Primary|Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F|This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)|26-week Treatment Period|All Randomized Subjects|||days||Inter-Quartile Range|Median
1267101|NCT00383240|Secondary|Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled.|Baseline to Week 26|ITT population with non-missing post-baseline AQLQ result|||units on a scale||Standard Deviation|Least Squares Mean
1267102|NCT00383240|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF||Baseline to Endpoint (12 weeks)|Intent to Treat (ITT) population|||liters x hours||Standard Deviation|Least Squares Mean
1267103|NCT00383162|Secondary|Recurrence of Any Migraine Headache Pain|Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.|24 hours and 48 hours|Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose. Placebo-23 subjects and Sumatriptan/Naproxen Sodium 54 subjects|||Participants|||Number
1267104|NCT00383162|Secondary|Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment.“Complete pain/symptom-free” was defined as migraine-free, neck pain-free, and sinus pain free.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267105|NCT00383162|Secondary|Sustained Complete Pain/Symptom-Free|Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267106|NCT00383162|Secondary|Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.|Baseline, 2, 4, and 8 hours|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267107|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Nausea|Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267108|NCT00383162|Secondary|Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267109|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Phonophobia|Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267110|NCT00383162|Secondary|Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had photophobia (sensitivity to light) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267111|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Photophobia|Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267156|NCT00383019|Secondary|Number of Subjects With an IOP of <=18 mmHg at Week 8|Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
1267114|NCT00383162|Secondary|Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had sinus pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267115|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Sinus Pain|Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267116|NCT00383162|Secondary|Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.|2, 4 , and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267117|NCT00383162|Secondary|Sustained Freedom From Migraine|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267118|NCT00383162|Secondary|Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|1/2, 1, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267119|NCT00383162|Secondary|Rescue Medication Used up to 24 Hours Post-dose|A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).|Dosing to 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267120|NCT00383162|Secondary|Pain-Free Assessment at 2 Hours Post-dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|2 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267121|NCT00383162|Primary|Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose|Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
1267122|NCT00383149|Secondary|Change From Baseline in FHSI-8 Total Score by Time-point|The FHSI-8 includes eight items representing pancreatic-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. Scoring of the FHSI-8 was to be conducted according to the Functional Assessment of Chronic Illness Therapy (FACIT) manual. The symptom assessment was to include treated participants who had baseline measurement and at least one on-study measurement of FHSI-8 questionnaire.|Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study)|Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, FHSI-8 score data were collected but not summarized.||||||
1267123|NCT00383149|Secondary|Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression|EGFR expression was evaluated by means of an immunohistochemical assay using tumor tissue collected prior to receiving first dose.|Baseline|Tissue was available for a small proportion of patients and only 1 out of 11 was EGFR positive, hence EFGR expression analysis was not performed.||||||
1267124|NCT00383149|Secondary|Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption|Dose reduction of ixabepilone and/or cetuximab due to toxicity was permitted for participants deriving benefit from therapy. Each drug could be dose modified independently of the others. Participants unable to start a cycle due to unacceptable toxicity related to ixabepilone or cetuximab could have therapy delayed for up to 4 weeks. If toxicities prevented the administration of ixabepilone or cetuximab therapy, participants continued receiving the other therapy as scheduled. A dose interruption for ixabepilone or cetuximab was defined as any interruption during the infusion period.|From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.|Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, dose modification data were collected but not summarized.||||||
1267125|NCT00383149|Secondary|Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)|Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB). Liver function laboratory evaluations included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Renal function laboratory evaluation included creatinine.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. n= number of participants with laboratory data available|||participants|||Number
1267126|NCT00383149|Secondary|Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. Acneform rash and peripheral neuropathy were captured by multiple MedDRA preferred terms. Acneform rash included rash, rash pustular, and rash pruritic preferred terms. Peripheral neuropathy included neuromuscular toxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy preferred terms.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab.|||participants|||Number
1267127|NCT00383149|Secondary|Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. The 53 participants reporting treatment-related AEs included 1 additional participant who also developed Grade 5 viscous intestinal perforation, which was also captured under death within 30 days of last dose category.|||participants|||Number
1267128|NCT00383149|Secondary|Median Time to Response|Time to response was defined as the number of weeks from first dose of study therapy (ixabepilone or cetuximab) until measurement criteria were first met for PR or CR, whichever status was recorded first. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.|Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.|Response-evaluable participants whose best response was PR or CR.|||weeks||Full Range|Median
1267129|NCT00383149|Secondary|Median Duration of Response|Duration of response was defined as the number of months from when measurement criteria were first met for CR or PR (whichever was recorded first) until the first date of disease progression or death. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.|From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).|Response-evaluable participants whose best response was PR or CR. Participants without disease progression or death were censored at the last tumor assessment date.|||months||95% Confidence Interval|Median
1267130|NCT00383149|Secondary|Median Overall Survival Time|Overall survival time was defined as the time in months from the first dosing date to the date of death.|From the first dosing date until death (last reported death was 21 months after first dose).|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without a reported date of death were censored at the last known alive date.|||months||95% Confidence Interval|Median
1267131|NCT00383149|Secondary|Median Progression Free Survival Time|Progression-Free Survival (PFS) time was defined as the time, in months, from the first dosing date until the date of disease progression or death from any cause.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without disease progression or death were censored at the last tumor assessment.|||months||95% Confidence Interval|Median
1267132|NCT00383149|Secondary|Percentage of Participants With Objective Tumor Response|Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression|Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.|||percentage of participants||95% Confidence Interval|Number
1267133|NCT00383149|Secondary|Best Overall Tumor Response|Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; Stable Disease (SD)= neither PR nor progressive disease (PD) criteria were met; PD = at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)|Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.|||participants|||Number
1267134|NCT00383149|Primary|Percentage of Participants Surviving at 6 Months|The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.|From time of first dose of study drug through 6 months|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants who did not die prior to 6 months but dropped out of the study were not included in the numerator.|||percentage of participants||95% Confidence Interval|Number
1267154|NCT00383019|Secondary|Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8|Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
1267135|NCT00383123|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)|"SAE: any untoward medical occurrence that~resulted in death,~was life-threatening,~required hospitalization or prolongation of existing hospitalization,~resulted in disability/incapacity, or~was a congenital anomaly/birth defect in the offspring of a study subject.~Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders."|Up to 6 months after vaccination||||Participants|||Count of Participants
1267136|NCT00383123|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination."|Within 28 days following vaccination||||Participants|||Count of Participants
1267137|NCT00383123|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.~Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination."|During a 4-day follow-up period after each vaccination|"Analysis was performed on vaccinated subjects with available data.~Pain, redness, swelling and fever were assessed in all age cohorts.~Drowsiness, irritability and loss of appetite were assessed in the 6 months to < 5 years cohort only.~Arthralgia, fatigue, headache, muscle aches and shivering were assessed in the 5 to < 18 years cohort only."|||Participants|||Count of Participants
1267138|NCT00383123|Secondary|Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer|Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.|21 or 28 days after last vaccine dose|As per protocol, only subjects from the ATP cohort for immunogenicity aged 6 months to < 5 years and with a baseline titre < 1:40 were analysed for this Outcome Measure.|||Participants|||Count of Participants
1267139|NCT00383123|Secondary|Number of Seroprotected Subjects|Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.|Before (PRE) and 21 or 28 days after (POST) the last vaccine dose|As per protocol, seroprotection was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom results were available.|||Participants|||Count of Participants
1267140|NCT00383123|Primary|Number of Subjects Reporting Rare Serious Events|"Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:~resulted in death,~was life-threatening,~required hospitalization or prolongation of existing hospitalization,~resulted in disability/incapacity, or~was a congenital anomaly/birth defect in the offspring of a study subject."|Up to 6 months after vaccination||||Participants|||Count of Participants
1267141|NCT00383123|Primary|Number of Seroconverted Subjects|"Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.~Data are presented for all 3 viral strains comprised in the vaccine."|21 or 28 days after last vaccine dose|As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom post-vaccination results were available.|||Participants|||Count of Participants
1267142|NCT00383123|Primary|Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies|GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.|21 or 28 days after last vaccine dose|Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to < 5 years).|||Titer||95% Confidence Interval|Geometric Mean
1267143|NCT00383110|Secondary|LDL-cholesterol||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.|||mg/dL||Standard Deviation|Mean
1267144|NCT00383110|Secondary|Diastolic Blood Pressure||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.|||mmHg||Standard Deviation|Mean
1267145|NCT00383110|Secondary|Systolic Blood Pressure||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.|||mmHg||Standard Deviation|Mean
1267146|NCT00383110|Primary|Health Care System Distrust Scale|Health Care System Distrust Scale is a valid and reliable 10-item measure of distrust of the health care system, measuring honesty confidentiality and confidence. All questions are measured on a Likert scale, with scores ranging from a minimum of 10 to a maximum of 50. Higher scores indicate more distrust in the health care system.|12 months after enrollment|Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.|||units on a scale||Standard Deviation|Mean
1267147|NCT00383110|Secondary|Hemoglobin A1c||12 months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.|||% HbA1c||Standard Deviation|Mean
1267148|NCT00383110|Primary|General Trust in Physicians Scale (GTIPS)|The GTIPS is a valid and reliable 11-item measure of general trust in physicians in the domains of dependability, confidence, and confidentiality of information. All items are fashioned in a 5-point Likert format with a minimum score of 11 and maximum of 55. Higher scores indicate more trust in physicians.|12 months following enrollment|Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.|||units on a scale||Standard Deviation|Mean
1267149|NCT00383084|Secondary|Functional Capacity (Higher Scores Indicative of Poorer Functioning)|Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100|Baseline and after 12-weeks||||units on a scale||Standard Deviation|Mean
1267150|NCT00383084|Secondary|Number of Tender Points on the Body|Number of tender points on physical examination (maximum number is 18)|Baseline and after 12-weeks||||tender points||Standard Deviation|Mean
1267159|NCT00383019|Secondary|Number of Subjects With an IOP of <=15 mmHg at Week 8|Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
1267160|NCT00383019|Secondary|Percent Change of IOP From Baseline to Week 8|Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||percent change||95% Confidence Interval|Least Squares Mean
1267161|NCT00383019|Secondary|Change of IOP From Baseline to Week 4|Value at Week 4 minus value at baseline|Baseline to Week 4|ITT|||mmHg||95% Confidence Interval|Least Squares Mean
1267162|NCT00383019|Primary|Change of Intraocular Pressure (IOP) From Baseline to Week 8|Value at Week 8 minus value at baseline|Baseline to Week 8|The primary efficacy analysis population was the Intent-to-treat population (ITT) which consisted of all subjects treated with the study drug as randomized. If there were any missing IOP values at Week 8, the data were supplemented by LOCF (Last Observation Carried Forward) using data at Week 4.|||mmHg||95% Confidence Interval|Least Squares Mean
1267163|NCT00382993|Secondary|Recurrence of Any Migraine Headache Pain|Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.|24 hours and 48 hours|Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose.|||Participants|||Number
1267164|NCT00382993|Secondary|Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment. “Complete pain/symptom-free” was defined as migraine-free, neck pain-free, and sinus pain free.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267165|NCT00382993|Secondary|Sustained Complete Pain/Symptom-Free|Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.|2 - 24 hours post-dose||||Participants|||Number
1267166|NCT00382993|Secondary|Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.|Baseline, 2, 4, and 8 hours|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267167|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Nausea|Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
1267168|NCT00382993|Secondary|Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267169|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Phonophobia|Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
1267170|NCT00382993|Secondary|Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had photophobia (sensitivity to light) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267171|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Photophobia|Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
1267172|NCT00382993|Secondary|Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of Participants with neck pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267173|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Neck Pain|Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
1267174|NCT00382993|Secondary|Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had sinus pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267175|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Sinus Pain|Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
1267176|NCT00382993|Secondary|Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.|2, 4 , and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267177|NCT00382993|Secondary|Sustained Freedom From Migraine|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.|2 - 24 hours post-dose||||Participants|||Number
1267195|NCT00382863|Secondary|Heart Failure Death|Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure|12 months|Population is intent to treat.|||participants|||Number
1267178|NCT00382993|Secondary|Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|0.5, 1, 4, and 8 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267179|NCT00382993|Secondary|Rescue Medication Use During 0 - 24 Hours Post-Dose|A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).|0-24 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267180|NCT00382993|Secondary|Migraine Headache Pain Free at 2 Hours Post-Dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|2 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267181|NCT00382993|Primary|Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose|Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.|2 - 24 Hours Post-Dose|ITT (Intent-to-Treat) Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
1267182|NCT00382967|Secondary|Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.|The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.|From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.|The numbers represent the number of changes in decisions that the Doctor made in the clinical management of the patient with Clinically Uncertain Parkinsonism|||Number of changes in clinical management|||Number
1267183|NCT00382967|Primary|Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.|The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.|Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)||||Number of changes in clinical management|||Number
1267184|NCT00382928|Secondary|Cerebral Performance at Discharge|"Cerebral Performance Categories/CPC scale:~CPC 1: Good cerebral performance – conscious, alert, able to work, might have mild neurologic or psychological deficit.~CPC 2: Moderate cerebral disability – conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.~CPC 3: Severe cerebral disability – conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.~CPC 4: Coma or vegetative state – any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness.~CPC 5: Brain death – apnea, areflexia, electroencephalogram (EEG) silence, etc."|At discharge|Only 1 patient in the Intervention group had defibrillation during hospital admission and his CPC was 1.|||units on a scale: CPC 1|||Number
1267185|NCT00382928|Secondary|Survival to Discharge||At discharge||||participants|||Number
1267186|NCT00382928|Secondary|Frequency of Abnormal Rhythms Monitored by the AECD||During the duration of hospital admission on the telemetry ward.|Only the AECD+Standard of Care Group was monitored in this portion of the study.|||participants|||Number
1267187|NCT00382928|Primary|Number of Participants Without Defibrillation|Time to defibrillation: interval between onset of VT/VF and delivery of first shock. Expected time to defibrillation for AECD group: 30±30 seconds; expected time to defibrillation for Standard of Care group: 180±180.|10 minutes|"There was only one patient in the Intervention group who received defibrillation.~No patients had CPR or defibrillation in the standard of care group."|||participants|||Number
1267188|NCT00382863|Secondary|Days Alive Out of Hospital|Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.|12 months|Population is intent to treat.|||days||Full Range|Median
1267189|NCT00382863|Secondary|Serious Adverse Events - Actuarial Analysis|Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events|12 months|Population is intent to treat.|||participants|||Number
1267190|NCT00382863|Secondary|Participants Experiencing Serious Adverse Events|Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment|12 months|Population is intent to treat.|||participants|||Number
1267191|NCT00382863|Secondary|All-Cause Hospitalization - Actuarial Analysis|Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations|12 months|Population is intent to treat.|||participants|||Number
1267192|NCT00382863|Secondary|All-Cause Hospitalization|Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.|12 months|Population is intent to treat.|||participants|||Number
1267193|NCT00382863|Secondary|Heart Failure Hospitalization|Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment.|12 months|Population is intent to treat.|||participants|||Number
1267194|NCT00382863|Secondary|Heart Failure Death - Actuarial Analysis|Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure|12 months|Population is intent to treat.|||participants|||Number
1267196|NCT00382863|Secondary|Technical Success (Number of Treatment Arm Participants Successfully Implanted)|"Technical success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis."|1 day|Population is as treated, treatment only.|||participants|||Number
1267197|NCT00382863|Secondary|Change in Left Ventricular End Systolic Diameter|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||centimeters||Full Range|Median
1267198|NCT00382863|Secondary|Change in Left Ventricular End Diastolic Diameter|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||centimeters||Full Range|Median
1267199|NCT00382863|Secondary|Change in Ejection Fraction|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented.|baseline to 6 months|Population is intent to treat.|||percent||Full Range|Median
1267200|NCT00382863|Secondary|Change in Left Ventricular End Systolic Volume|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||milliliters||Full Range|Median
1267201|NCT00382863|Secondary|Change in Left Ventricular End Diastolic Volume|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||milliliters||Full Range|Median
1267202|NCT00382863|Secondary|Heart Failure Hospitalization - Actuarial Analysis|Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment|12 months|Population is intent to treat.|||participants|||Number
1267203|NCT00382863|Secondary|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score|"A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score."|baseline to 12 months|Population is intent to treat.|||participants|||Number
1267204|NCT00382863|Secondary|Responder Analysis - Six (6) Minute Walk (6MW) Distance|"A participant was considered a responder if 6MW distance at 12 months was at least 45 meters more than at baseline."|baseline to 12 Months|Population is intent to treat|||participants|||Number
1267205|NCT00382863|Secondary|Responder Analysis - Peak Oxygen Uptake (Peak VO2)|"A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline."|baseline to 12 months|Population is intent to treat.|||participants|||Number
1267206|NCT00382863|Secondary|Change in Left Ventricular Mass|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||grams||Full Range|Median
1267207|NCT00382863|Secondary|Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented.|baseline to 6 months|Population is intent to treat|||score on a scale||Standard Deviation|Mean
1267208|NCT00382863|Secondary|Change in New York Heart Association (NYHA) Functional Class|"Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remained the same as baseline. Improved means the participant's functional class improved (became lower in number) by at least one class. Worsened means the participant's functional class deteriorated (became higher in number) by at least one class."|baseline to 6 months|Population is intent to treat.|||participants|||Number
1267209|NCT00382863|Primary|Number of Participant Deaths|Total number of participants who died within 12 months of enrollment into the trial.|12 months|The population is intent to treat.|||participants|||Number
1267210|NCT00382863|Primary|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score|"A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score."|baseline to 6 months|The population is intent to treat.|||participants|||Number
1267211|NCT00382863|Primary|Responder Analysis - Six (6) Minute Walk (6MW) Distance|"A participant was considered a responder if 6MW distance at 6 months was at least 45 meters more than at baseline."|Baseline to 6 months|The population is intent to treat.|||participants|||Number
1267212|NCT00382863|Primary|Responder Analysis - Peak Oxygen Uptake (Peak VO2)|"A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline."|Baseline to 6 months|The population is intent to treat.|||participants|||Number
1267237|NCT00382265|Secondary|Crossover to Open Label Tamsulosin||28 days||||Participants|||Count of Participants
1267213|NCT00382785|Primary|Scores on the Quality of Life (QOL) Question on the Rotterdam Symptom Check List (RSCL).|The Rotterdam Symptom Checklist (RSCL) measures quality of life in cancer patients. The RSCL checklist includes a QOL life question on a scale of 1 (excellent) to 7 (extremely poor). This was used as a measure of overall QOL.|16 weeks||||Scores on a scale||Standard Error|Mean
1267214|NCT00382785|Primary|Scores on the CES-D Scale|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report scale widely used in the assessment of depression. Each item is given a rating of 0 to 3, with a potential range of 0 to 60 for the entire scale. Higher scores are associated with depression. The cutoff for the diagnosis of Major Depressive Disorder on the CES-D is 16. The instrument is a reliable measure (Alpha >.85) of depression|16 weeks|Same as number of participants analyzed|||Scores on a scale||Standard Error|Mean
1267215|NCT00382785|Primary|Scores on the Personal Resource Questionnaire 85.|The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at >.90|16 weeks||||Scores on a scale||Standard Error|Mean
1267216|NCT00382733|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of disease progression. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Best overall response was assessed after every 8 weeks of treatment and at the end of treatment or time of disease progression, up to 1 year.|All enrolled subjects were analyzed for this outcome.|||participants|||Number
1267217|NCT00382733|Secondary|Dose Limiting Toxicities (DLT)|DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. This measure reports the number of subjects who experienced DLT at each dose level during the dose finding portion of the study.|DLTs were assessed during the first cycle of treatment (days 1-28).|Number of participants analyzed refers to those for whom DLT information was available during the dose finding portion of the study.|||participants|||Number
1267218|NCT00382733|Primary|Maximum Tolerated Dose (MTD) of Single Agent Metronomic Oral Topotecan|The MTD of metronomic oral topotecan was determined using a standard 3+3 dose escalation cohort design. The total sample and the number of subjects who receive each dose in this design depends on the frequency of dose limiting toxicities (DLTs)at each dose level. If 0 out of 3 subjects experience a DLT at a given dose level, 3 subjects will be enrolled at the next higher dose level. If greater than or equal to 2 subjects experience a DLT at a given dose level, dose escalation will be stopped. If 1 out of 3 subjects experience a DLT at a given dose level, 3 subjects are enrolled at the same dose level.|MTD was assessed during the first cycle of treatment (days 1-28).|DLT information was available for 3 subjects who received a topotecan dose of 0.25 mg/day, 3 subjects who received a topotecan dose of 0.50 mg/day, 3 subjects who received a topotecan dose of 0.75 mg/day, 3 subjects who received a topotecan dose of 1.0 mg/day, and 2 subjects who received a topotecan dose of 1.25 mg/day.|||mg/day|||Number
1267219|NCT00382720|Secondary|Overall Survival (OS)|The number of months measured from the date of randomization to the date of death due to any cause.|up to a maximum of 36 months|248 participants in the full analysis population (FAP).|||months||95% Confidence Interval|Median
1267220|NCT00382720|Secondary|Best Overall Response Rate (ORR)|"Percentage of partial and complete responses, according to WHO criteria:~Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.~Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart."|every 8 weeks up to a maximum of 36 months|248 participants in the full analysis population (FAP).|||percentage of participants||95% Confidence Interval|Number
1267221|NCT00382720|Primary|Time to Progression|"The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause.~WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion."|every 8 weeks up to a maximum of 36 months|248 participants in the full analysis population (FAP).|||Months||95% Confidence Interval|Median
1267222|NCT00382590|Primary|Number of Participants With Response|Patient response defined by: Death, Resistant to Therapy [no major hematologic improvement using International Myelodysplastic Syndromes (MDS) Working Group (Cheson B, Bennett J, Kantarjian H et al, Blood 2006) criteria after a maximum of 4 courses], or Relapse.|Evaluated every 3 weeks, following 4 courses (16/24 weeks ) and till study end|The analysis was per intention to treat. One participant was inevaluable for response.|||Participants|||Number
1267223|NCT00382408|Secondary|Percentage of Participants Showing ADV Type-7 Booster at Week 4|ADV-7 booster effect is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-7 titer is ≥1:4.|Baseline, Week 4|Type-7 ADV Booster Cohort included subjects who had a positive Type-7 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-7 at the subsequent visits following study medication administration.|||percentage of participants||95% Confidence Interval|Number
1267224|NCT00382408|Secondary|Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-7 vaccine, the number of cases of ADV-7 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
1267238|NCT00382265|Secondary|Need for Surgical Intervention||28 days||||Participants|||Count of Participants
1267239|NCT00382265|Secondary|Any Pain Medication|Patients on any pain medication at day 28|28 days||||Participants|||Count of Participants
1267225|NCT00382408|Secondary|Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-7 vaccine, a secondary outcome is the number of cases of ADV-7 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
1267226|NCT00382408|Secondary|Percentage of Participants Showing ADV Type-4 Booster at Week 4|ADV-4 booster effect is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-4 titer is ≥1:4.|Baseline, Week 4|Type-4 ADV Booster Cohort included subjects who had a positive Type-4 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-4 at the subsequent visits following study medication administration.|||percentage of participants||95% Confidence Interval|Number
1267227|NCT00382408|Secondary|Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-4 vaccine, the number of cases of ADV-4 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
1267228|NCT00382408|Secondary|Percentage of Participants Showing ADV-4 Seroconversion at Week 4|ADV-4 seroconversion was defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-4 titer was <1:4.|Week 4|Type-4 ADV Seroconversion Cohort: Included those subjects who had a negative Type-4 ADV serum neutralizing antibody status at baseline (<1:4) and at least one titer value for ADV-4 at the subsequent visits following vaccination.|||percentage of participants||95% Confidence Interval|Number
1267229|NCT00382408|Primary|Percentage of Participants Showing ADV-7 Seroconversion at Week 4|ADV-7 seroconversion was defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-7 titer was <1:4.|Week 4|Type-7 ADV Seroconversion Cohort: Included those subjects who had a negative Type-7 ADV serum neutralizing antibody status at baseline (<1:4) and at least one titer value for ADV-7 at the subsequent visits following vaccination.|||percentage of participants||95% Confidence Interval|Number
1267230|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort; further, this outcome omitted ARD cases from Day 0-Day 10 because the protective effect of the vaccine was unlikely to take place during that time period.|Day 11 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
1267231|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the per protocol cohort.|Day 0 - Day 56|The per-protocol (PP) cohort included all participants who met the eligibility criteria set forth in the protocol, did not have any significant violations or deviations from the protocol, and completed the final study visit (Day 56). Subjects who vomited within 24 hours after taking the study medication were excluded from the PP cohort.|||participants|||Number
1267232|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
1267233|NCT00382291|Primary|Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score|The CY-BOCS (Scahill et al., 1997) is a semi-structured, clinician rated instrument to measure OCD symptom severity in youth. The CY-BOCS contains a symptom checklist and a severity scale. Through the symptom checklist the clinician assesses current and past experiences of over 60 potential obsessions and compulsions. The Total Score represents the sum of obsession severity and compulsion severity which each consist of five clinician ratings on a Likert scale (range from 0 (none) to 4 (extreme), for time spent, interference, distress, resistance and control over symptoms). Summing of obsession and compulsion severity (range 0-20 on each) produces the Total CY-BOCS score (range 0-40, with 0 representing the best and 40 the worst outcome). Studies have documented good psychometric properties of the CY-BOCS (Gallant et al., 2008; Scahill et al., 1997; Storch et al., 2004).|Measured at Week 18 or End of Study||||units on a scale||Standard Deviation|Mean
1267234|NCT00382291|Primary|Clinical Global Impression – Severity of Activation (CGI-SA)|The CGI-SA was adapted from the Clinical Global Impressions – Severity of Illness (CGI-SI) rating (Guy, 1976). The CGI-SI is commonly used in clinical studies of children and adults and has been extensively validated (Zaider et al., 2003). On the CGI-SA clinicians rate the severity of activation symptoms on a range from 0 (no activation) to 7 (extremely severe symptoms, functionally highly impaired and/or extreme distress). We report values representing Median+/-Std Dev for the maximum CGI-SA obtained over the course of study.|Measured at screening, baseline and weekly until end of week 8 after baseline, then monthly for two months and finally at end of study|Per protocol, Intent to treat|||units on a scale||Standard Deviation|Median
1267235|NCT00382265|Secondary|Return to Work (if Employed)||28 days||||Participants|||Count of Participants
1267236|NCT00382265|Secondary|Confirmation of Stone Passage on CT||28 days||||Participants|||Count of Participants
1267240|NCT00382265|Primary|Proportion of Patients Passing Their Stone Within 28 Days by Self Report|Hypothesis: The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis will produce an increase in the proportion of patients passing their stone within 28 days.|28 days||||Participants|||Count of Participants
1267241|NCT00382174|Secondary|Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days|Incidence of wound healing at the end of the study, Day 84|Up to 84 days|Analysis was per protocol,ITT, and using LOCF|||Number of healed participants|||Number
1267242|NCT00382174|Primary|Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days|All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population|Up to 84 days||||participants|||Number
1267243|NCT00382148|Secondary|Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.|Through Week 52|safety-evaluable population|||participants|||Number
1267244|NCT00382148|Secondary|Food-allergic Reactions As Assessed by the Ewan Scale|"The Ewan scale has five ascending grades of severity from Grade 1 to Grade 5 (as well, there is a possible value of Not Applicable). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator"|Through Week 52|safety-evaluable population|||participants|||Number
1267245|NCT00382148|Secondary|Food Allergen Exposure, Assessed on Patient-reported Questionnaire|"Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify) and Did you have a reaction? (Yes/No)."|Every 4 weeks through Week 52||||participants|||Number
1267246|NCT00382148|Primary|Serious Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator|Through Week 52|Safety-analysis population|||participants|||Number
1267247|NCT00382109|Secondary|Chimerism|Evaluate the relative contribution of resistance by ALL blasts to the donor immune response as a cause of relapse post transplantation.|Up to 12 months|We are not able to perform this analysis given the low numbers of blast samples available.||||||
1267248|NCT00382109|Secondary|Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Pre-Transplantation (MRD)|An event is defined as relapse; relapse risk is reported. Not able to be performed given the low numbers of blast samples available.|At 2 months|The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol. However, we are not able to perform this analysis given the low numbers of blast samples available.||||||
1267249|NCT00382109|Secondary|Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Post Transplantation (Correlating Development of aGVHD With Relapse)|An event is defined as relapse; estimated probability of relapse.|At 1 year|Number at risk among no aGVHD and number at risk among aGVHD at 1 year. The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol, therefore results are not reported for each Arm of study.|||percentage of participants|||Number
1267250|NCT00382109|Secondary|Relative Contribution of Resistance by Acute Lymphoblastic Leukemia (ALL) Blasts to Cytolytic Therapy (e.g., Chemotherapy/Irradiation) as a Cause of Relapse Post-transplantation|An event is defined as relapse or transplant-related mortality.|Up to 1 year|We made a large number of xenograft models but were not able to correlate resistance to rapamycin in mice with outcome on the trial with the numbers that we had. For this reason, no specific publications addressing this aim were put forward.||||||
1267251|NCT00382109|Secondary|Estimated Rate of Overall Chronic Graft VS Host Disease|Chronic graft vs host disease is defined in APPENDIX III of study protocol.|At 2 years|2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.|||percentage of participants||95% Confidence Interval|Number
1267252|NCT00382109|Secondary|Estimated Rate of Acute Graft VS Host Disease (GVHD)|Any grade acute graft vs host disease (defined in APPENDIX II study protocol).|At 200 days|2 ineligible patients on experimental arm excluded from analysis. Definition of Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.|||percentage of participants||95% Confidence Interval|Number
1267253|NCT00382109|Secondary|Estimated Transplant Related Mortality Percentage|Death in a patient who had not relapsed after transplant is defined as transplant-related mortality event.|100 days|2 ineligible patients on experimental arm excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1267254|NCT00382109|Secondary|Rate of Relapses|An event is defined as relapse.|At 2 years|2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.|||percentage of participants||95% Confidence Interval|Number
1267255|NCT00382109|Primary|Estimated Percentage of Participants With Event Free Survival|An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol.|at 2 years|Two ineligible patients on experimental arm excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1267256|NCT00382031|Secondary|Progression Free Survival (PFS)|PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient.|From randomization until disease progression or death, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.|||weeks||95% Confidence Interval|Median
1271398|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 4|Mean weekly morning peak expiratory flow at week 4, pre-dose|After 4 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
1267257|NCT00382031|Secondary|Duration of Response|Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented.|Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.|||month||95% Confidence Interval|Median
1267258|NCT00382031|Secondary|Objective Tumor Response|Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|From date of randomization until the date of death from any cause, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.|||participants|||Number
1267259|NCT00382031|Primary|Overall Survival|A patient’s overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.|From randomization until death|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.|||months||95% Confidence Interval|Median
1267260|NCT00382018|Other Pre-specified|Correlation of CTC Levels With Breast Cancer Tumor Markers||Baseline, Weeks 4, 8, 13, 25, 37 and at progression|||||||
1267261|NCT00382018|Secondary|Number of Patients With Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression|Patients in 'Arm A (Baseline CTCs < 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. And only patients who were evaluable for Adverse Event Assessment were included in the following analysis results.|||Participants|||Number
1267262|NCT00382018|Primary|Progression Free Survival|From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.|every 3 months until progression|Three patients in Arm C were judged as progressing on day 22 and were excluded from the PFS analysis but were included in the OS analysis.|||months||95% Confidence Interval|Median
1267263|NCT00382018|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months until progression then every 6 months for 5 years or until death||||months||95% Confidence Interval|Median
1267264|NCT00382018|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.|Three patients in Arm C2 were judged as progression on day 22 and were excluded from the PFS analysis but were included in the OS analysis.|||months||95% Confidence Interval|Median
1267265|NCT00382018|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months until progression then every 6 months for 5 years or until death||||months||95% Confidence Interval|Median
1267266|NCT00381966|Primary|Utility of the Needle Position Device: Number of Adjustments Possible Out of Adjustments Attempted|Utility was demonstrated in terms of fine adjustments (≤ 2 mm) and adjustments >2mm in needle positioning, being possible when tissue deflection was encountered.|at time of intervention||||Number of Adjustments|Number of Adjustments||Count of Units
1267267|NCT00381966|Primary|Positioning Effectiveness as Determined by Confirmatory Measurements of Robotic Movements|Confirmatory measurements of robotic movements was assessed using infrared tracking to calculate mean error in millimeters.|at time of intervention||||millimeters||Standard Deviation|Mean
1267268|NCT00381940|Secondary|Biological Markers|Assessing baseline NF-kB protein levels in tumor tissue|Before, during, and after treatment|||||||
1267269|NCT00381940|Secondary|Rate of Successful PBSC Harvest|Success is defined as the ability to harvest 2x10^6 CD34+ cells/kg within 5 collection days.|After 2 cycles|||||||
1267270|NCT00381940|Secondary|Induction Success Rate|Induction success is defined as achieving CR or PR without a targeted primary toxicity.|After 2 cycles and 4 cycles|||||||
1267271|NCT00381940|Secondary|Overall Response Rate|Overall response includes complete response and partial response.|After 2 cycles and 4 cycles|||||||
1267272|NCT00381940|Secondary|Toxicity||4 weeks following completion of therapy|||||||
1267273|NCT00381940|Primary|Complete Response (CR)|CR is defined as at least 80% reduction in the sum of the products of the perpendicular diameters of each of the nodal masses or return to normal size, along with negative nuclear medicine imaging.|After 2 cycles of treatment|Analysis population includes all patients evaluable for tumor response. Three enrolled patients are excluded: 1 ineligible, 1 who was removed from treatment after 1 dose of bortezomib, and 1 who received only 1/3 dose of bortezomib in cycle 1 and part of cycle 2 due to pharmacy error.|||participants|||Number
1267274|NCT00381888|Secondary|Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.|This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.|Week 4|These patients completed the study and are considered evaluable for this outcome measure.|||Participants|||Number
1271440|NCT00349466|Secondary|Use of Artificial Tears|daily use of REFRESH TEARS® Lubricant Eye Drops artificial tears supplied to each patient was recorded in diaries provided to patients|12 weeks|||||||
1267275|NCT00381888|Primary|Number of Patients With Venous Thromboembolism at Week 4|Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.|Week 4 (Days 28-35)|The number includes those patients who completed the study and are evaluable for this outcome measure.|||Participants|||Number
1267276|NCT00381862|Secondary|Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy||within 5 days of chemotherapy|||||||
1267277|NCT00381862|Secondary|To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy.||Duration of time patient is on study|||||||
1267278|NCT00381862|Secondary|Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.||Duration of time the patient is on study|||||||
1267279|NCT00381862|Secondary|Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy||Duration of time that the patient is on study|||||||
1267280|NCT00381862|Primary|Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.||Up to 24 weeks||||Participants|||Number
1267281|NCT00381849|Primary|Volume of Kidney Stones as Measured on Computerized Tomography|Measurement of kidney stone volume in cubic millimeters.|Baseline, approximately 52 weeks after baseline|One subject was excluded from CT analysis because of bilateral stone removal surgery during the study.|||mm^3||Standard Deviation|Mean
1267282|NCT00381849|Primary|Stone Density as Measured by Agatston Score Via Computerized Tomography|Agatston results are a measure of calcium typically used for measuring coronary artery calcification.|Baseline, approximately 52 weeks after baseline|One subject was excluded from CT analysis because of bilateral stone removal surgery during the study|||Agatston Score||Standard Deviation|Mean
1267283|NCT00381849|Primary|24 Hour Urinary Cystine Excretion||baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Cystine excretion was not applicable to the Calcium Stone subjects.|||mcmol/24 hours||Standard Deviation|Mean
1267284|NCT00381849|Secondary|Change in Stone Burden as Assessed by Radiologist at One Year|Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.|Baseline, approximately 52 weeks after baseline|One subject in the Calcium group was excluded from the CT analysis because of bilateral stone removal surgery during the study.|||Kidneys|||Number
1267285|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Hydroxyapatite was not analyzed for the Cystine Stone subjects.|||KJoules/mol||Standard Deviation|Mean
1267286|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Brushite was not analyzed for the Cystine Stone subjects.|||KJoules/mol||Standard Deviation|Mean
1267287|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|CaOx was not analyzed for the Cystine Stone subjects.|||KJoules/mol||Standard Deviation|Mean
1267288|NCT00381810|Primary|Percentage of Participants With at Least 1 Serious Adverse Event|A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.|Baseline to the end of the study (up to 52 weeks)||||Percentage of participants|||Number
1267289|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by VEGF-R2 Expression|The association of VEGF-R2 expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with VEGF-R2 measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of VEGF-R2 expression with progression-free survival.|||Hazard Ratio||95% Confidence Interval|Number
1267290|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by VEGF-A Expression|The association of VEGF-A expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with VEGF-A measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of VEGF-A expression with progression-free survival.|||Hazard Ratio||95% Confidence Interval|Number
1267318|NCT00381706|Secondary|Overall Survival in Patients With Adenocarcinoma|Overall survival (OS) was defined as the time from study entry to death of any cause. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment||||months||95% Confidence Interval|Median
1267291|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by Carbonic Anhydrase 9 (CA9) Expression|The association of CA9 expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with CA9 measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of carbonic anhydrase 9 (CA9) expression with progression-free survival.|||Hazard Ratio||95% Confidence Interval|Number
1267292|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by Hypoxia Inducible Factor-2alpha Expression|The association of hypoxia inducible factor-2alpha expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with hypoxia inducible factor-2alpha measurements. The hazard ratio was reported for patients who had hypoxia inducible factor-2alpha expression.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|The number of patients in strata C and D was not sufficient to perform the analysis exploring the association of hypoxia inducible factor-2alpha expression with progression-free survival. Thus the association analysis was performed for the patients in Stratum E only.|||Hazard Ratio||95% Confidence Interval|Number
1267293|NCT00381797|Secondary|Number of Patients With High VEGF-R2 Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.|||participants|||Number
1267294|NCT00381797|Secondary|Number of Patients With High VEGF-A Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.|||participants|||Number
1267295|NCT00381797|Secondary|Number of Patients With High Carbonic Anhydrase 9 Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.|||participants|||Number
1267296|NCT00381797|Secondary|Number of Patients With High Hypoxia Inducible Factor-2alpha Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.|||participants|||Number
1267297|NCT00381797|Secondary|Correlation of the Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) From Baseline With the Change in Perfusion From Magnetic Resonance Imaging|Spearman correlation coefficient is used to measure the correlation of the changes in VEGF-R2 with the changes in perfusion ratios. The changes are calculated by values at Day 15 minus values at baseline for VEGF-2 in Section 17 above and perfusion in Section 18 above, respectively. The correlation coefficients are reported in each stratum separately.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.|||Correlation Coefficient|||Number
1267298|NCT00381797|Secondary|Descriptive Statistics for the Change of Perfusion in Magnetic Resonance Imaging Concurrently Measured With the Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC)|The change of perfusion in magnetic resonance imaging is calculated by taking the difference between the Day-15 measurements and the Baseline measurements for patients who had the changes of VEGF-R2. The purpose of reporting the descriptive statistics is to provide the information for the correlation coefficients reported in the next section, Section 19. MR perfusion ratio is the ratio of the perfusion measurements in the tumor and the perfusion measurerement in comparative frontal while matter, which is the comparative healthy part of the brain.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.|||Ratio||Standard Error|Mean
1267299|NCT00381797|Secondary|Descriptive Statistics for the Changes in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) Concurrently Measured With the Changes in Perfusion From Magnetic Resonance Imaging|The changes in VEGF-R2 are calculated by values at Day 15 minus values at baseline for the patients who had the changes in perfusion from magnetic resonance perfusion imaging. The purpose of reporting descriptive statistics of changes of VEGF-R2 is to provide the information for the correlation coefficients in Section 19.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.|||Ratio||Standard Error|Mean
1267300|NCT00381797|Secondary|Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) From Baseline to Day-15|The change in VEGF-R2 was calculated from baseline to the time of the 2nd dose (values of 24-48 hours after the 2nd dose at Day 15 - values of pre-dose 1 Day1, i.e., baseline). VEGF-R2 is measured in the relative phosphorylation score which is generated as a ratio of normalized phosphorylated VEGF-R2 versus normalized total VEGF-R2 protein.|Baseline and 24-48 hours after the 2nd dose of Bevacizumab in course 1||||Ratio||Full Range|Median
1267301|NCT00381797|Secondary|Terminal Half-life|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the PK parameters. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology,2016 volume 81(1):148-160. The estimates of the terminal half-life were calculated by the method described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with available data.|||hours||Standard Deviation|Mean
1267302|NCT00381797|Secondary|Systemic Clearance|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the systemic clearance. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology, 2016 volume 81(1):148-160. The estimates of the systemic clearance were calculated by the model described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with available data.|||ml/h||Standard Deviation|Mean
1267303|NCT00381797|Secondary|Volume of Distribution|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the volume of distribution. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology ,2016 volume 81(1):148-160. The estimates of the volume of distribution were calculated by the model described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with available data.|||ml||Standard Deviation|Mean
1267304|NCT00381797|Secondary|Association of Log-transformed Tumor Perfusion Ratio With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of tumor perfusion ratio with progression-free survival will be investigated. Magnetic resonance (MR) perfusion imaging is performed to investigate surrogate markers of tumor growth. Tumor perfusion ratios were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume perfusion ratio. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|The analyses cannot be performed with the Cox proportional hazard model since there are no sufficient measurements of perfusion ratio and events.||||||
1267305|NCT00381797|Secondary|Association of Log-transformed Tumor Diffusion Ratio With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of tumor diffusion ratios with progression-free survival will be investigated. Magnetic resonance (MR) diffusion imaging is performed to investigate surrogate markers of tumor growth. Tumor diffusion ratios were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. And we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor diffusion ratio. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Patients had diffusion ratio at pre-treatment scans and at least one on treatment scans.|||Hazard Ratio||95% Confidence Interval|Mean
1267306|NCT00381797|Secondary|Association of Log-transformed Volume of Cystic Necrosis With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of cystic necrosis with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Volumes of cystic necrosis were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on cystic necrosis. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|Patients had volume of cystic necrosis at Pre-treatment and at least one on treatment.|||Hazard Ratio||95% Confidence Interval|Mean
1267307|NCT00381797|Secondary|Association of Log-transformed Tumor Enhancing Volume With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional hazards Models, the association of Log-transformed tumor enhancing volume with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Tumor enhancing volumes were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor enhancing volume. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|Patients had tumor enhancing volume at Pre-treatment and at least one on treatment.|||Hazard Ratio||95% Confidence Interval|Mean
1267560|NCT00379912|Secondary|Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles||6 months|Analysis of CD34, CD71, and CD36 cells was undertaken irrespective of arm assignment.|||cells of BM (10e^6/ML)||Standard Error|Mean
1267308|NCT00381797|Secondary|Association of Log-transformed Tumor Volume Based on FLAIR With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox proportional hazards models, the association of tumor volume based on FLAIR images with PFS will be investigated for those strata that have a sufficient number of participants with volume FLAIR measurements. Volumetric magnetic resonance imaging is performed to investigate surrogate markers of tumor growth. Volume FLAIR measurements were longitudinal. As we are not comparing the strata, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on FLAIR. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study OR up to 2 years|Patients had Flair volume at Pre-treatment and at least one on treatment.|||Hazard Ratio||95% Confidence Interval|Mean
1267309|NCT00381797|Secondary|Change in Diffusion Ratio Between the Baseline and Day 15 Brain Image|Diffusion ratio obtained from magnetic resonance (MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the diffusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from diffusion ratio at Baseline to diffusion ratio at Day 15 (values of diffusion ratio at Day 15 -values of diffusion ration at baseline). The higher of diffusion ratio is better. MR diffusion ratio is the diffusion solid part of tumor divided by the diffusion frontal white matter. There is no a unit available.|Baseline and day 15|There are no sufficient data for the analyses in the Medulloblastoma arm.|||Ratio||Full Range|Median
1267310|NCT00381797|Secondary|Change in Perfusion Ratio Between the Baseline and Day 15 Brain Imaging|"Perfusion ratio obtained from magnetic resonance(MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the perfusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from perfusion ratio at Baseline to perfusion ratio at Day 15(values of perfusion ratio at Day 15 - values of perfusion ratio at baseline). The higher of perfusion ratio is worse.~MR perfusion ratio is perfusion solid part of tumor from CBV divided by perfusion frontal while matter. There is no a unit available."|Baseline and day 15|There are no sufficient data for the analyses in the Medulloblastoma arm and Ependymoma arm.|||Ratio||Full Range|Median
1267311|NCT00381797|Secondary|Progression-free Survival|Progression-Free survival is the interval of time between of protocol treatment and minimum date of documentation of progressive Disease,second malignancy,death due to any cause, or date of last follow-up. Progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression,OR the appearance of new tumor OR a > 25% increase in the sum of the products of two longest perpendicular diameters of all measurable tumors. K-M method was used to estimate progression-free survival.|From start of treatment up to 2 years|The patients were treated with any dose treatment.|||Months||95% Confidence Interval|Median
1267312|NCT00381797|Secondary|Cumulative Incidence of Sustained Objective Responses|Cumulative incidence of sustained objective response provides a percentage of participants experiencing the event of interest at a given follow-up time point (for example, 6-months, 1-year, etc.) in the presence of competing events such as progressive disease or death, and it is estimated using the event data for both the event of interest and the competing events experienced by the study participants. In this sense, it is different than the incidence rates estimated in epidemiological studies in terms of 'incidences per 1000 person years. 6-month Cumulative incidence of sustained objective responses will be reported separately for each stratum.|From the first imaging after treatment up to 2 years|Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.|||Percentage of Participants|||Number
1267313|NCT00381797|Secondary|Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity|Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events. The grade 1 = mild, grade 2=moderate, grade 3 =severe, grade 4=life threatening/disabling, grade 5=death.|From day 1 of treatment until off study|The patients were treated with any dose treatment.|||participants|||Number
1267314|NCT00381797|Primary|Sustained Disease Stabilization Rate Associated With Bevacizumab and Irinotecan in Patients With Recurrent or Progressive Low-grade Glioma (Stratum E)|Disease stabilization is defined as a complete response(CR) or partial response(PR) observed during the first four courses and sustained for 8 weeks; or stable disease (SD) sustained for 6 courses characterized by SD at the end of course 2, at the end of course 4 and at the end of course 6. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size. SD is at least stable and maintenance corticosteroid dose not increased in neurologic examination.|From day 1 of treatment up to 24 weeks|Patients with recurrent or progressive low grade glioma were treated with any courses.|||participants||95% Confidence Interval|Number
1267315|NCT00381797|Primary|Objective Response Rate Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response observed during the first four courses of treatment and sustained for 8 weeks. The objective response rate will be reported separately for patients with recurrent/progressive malignant glioma(Stratum A), recurrent/progressive instrinsic brain stem tumors(Stratum B), recurrent/progressive medulloblastoma(Stratum C), and recurrent/progressive ependymoma(Stratum D). CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size. This outcome measures is not defined for the Stratum E in the protocol.|From day 1 of treatment up to 24 weeks|Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.|||participants|||Number
1267316|NCT00381706|Secondary|Time to Treatment Failure in Patients With Adenocarcinoma|Time to treatment failure (TTF) was measured from study entry until documented progression, death resulting from any cause, or end of protocol therapy because of unacceptable toxicity. The median TTF with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment||||months||95% Confidence Interval|Median
1267317|NCT00381706|Secondary|Progression-free Survival in Patients With Adenocarcinoma|Progression free survival (PFS) was defined as the time from study entry to progression or death of any cause. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment||||months||95% Confidence Interval|Median
1267319|NCT00381706|Secondary|Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with squamous cell carcinoma who have received at least one cycle of therapy.|Up to 2 years post-treatment|4 participants did not meet the protocol defined requirements to be evaluated for response (measurable squamous cell carcinoma receiving at least 1 cycle of chemotherapy).|||percentage of participants|||Number
1267320|NCT00381706|Primary|Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy.|Up to 2 years post-treatment|13 participants did not meet the protocol defined requirements to be evaluated for response (measurable adencarcinoma receiving at least 1 cycle of chemotherapy).|||percentage of participants||95% Confidence Interval|Number
1267321|NCT00381693|Secondary|Number of Participants With Treatment Related Adverse Events|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.~Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE"|Every 4 weeks during treatment||||Participants|||Number
1267322|NCT00381693|Secondary|Time to Progression|Time to progression was defined as the time from registration to progression of disease. Those who die without documentation of disease progression will be considered to have had disease progression at the time of their death unless documented evidence clearly indicates no progression has occured.|up to 3 years|Only 2 out of 10 patients had disease progression. One patient progressed at 0.5 months after registration and one patient progressed at 2.8 months after registration. Thus, median of time to progression and upper limit of 95% confidence interval are not attainable.|||months||95% Confidence Interval|Median
1267323|NCT00381693|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death due to any cause or time from registration to 3 years after registration if patient is still alive.|From date of registration until death or 3 years after registration if patient is still alive||||months||95% Confidence Interval|Median
1267324|NCT00381693|Primary|Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment|"Response Definitions:~Completion Remission (CR):complete resolution of disease-related symptoms, ultrasound-documented resolution of hepastosplenomegaly, normalization of the peripheral blood count, white cell differential, and smear, normalization of bone marrow histology including disappearance of fibrosis and osteosclerosis. Residual cytogenetic abnormalities are allowed.~Partial Remission (PR): a major response in any baseline applicable criteria (except constitutional symptoms) without progression in any other category."|4 months||||participants|||Number
1267325|NCT00381680|Secondary|Adjusted Event Free Survival|Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT).|3 years|The analysis is limited to eligible patients on Standard VCR dosing who received matched related SCT, excluding patients who had events prior to receiving SCT. And those patients on Regimen A who did not undergo SCT, excluding patients who went off therapy prior to the adjusted starting time.|||adjusted percentage of participants||95% Confidence Interval|Number
1267326|NCT00381680|Secondary|Event Free Survival (EFS)|Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months.|3 years|The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months. Pts with MRD <0.01% at the end of Block 1 (MRD < 0.01% BL1); MRD >= 0.01% at the end of Block 1 (MRD>= 0.01% BL1); MRD < 0.01% at the end of Block 3 (MRD < 0.01% BL3);MRD >=0.01% at the end of Block 3.|||percentage of participants||95% Confidence Interval|Number
1267327|NCT00381680|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3|Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.|End of Block 3 (105 days) of Induction therapy|This analysis is limited to all eligible patients with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.|||percentage of participants|||Number
1267328|NCT00381680|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1|Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1|End of Block 1 (35 days) of Induction therapy|This analysis is limited to all eligible patients with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1.|||percentage of participants|||Number
1267329|NCT00381680|Secondary|Gene Expression Profile|Percent of unfavorable gene expression profile of early versus late marrow relapse.|Up to 36 months|The data were not collected due to the lack of funds.||||||
1267330|NCT00381680|Secondary|Frequency and Severity of Adverse Effects|Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.|Up to 107 weeks|The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.|||percentage of participants||95% Confidence Interval|Number
1267331|NCT00381680|Primary|Event Free Survival. EFS|Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).|3 years after enrollment|The analysis is limited to eligible patients on regimen A (Standard VCR dosing) who did not undergo SCT.|||percentage of participants EFS at 3 yrs3||95% Confidence Interval|Number
1267332|NCT00381641|Other Pre-specified|Changes in Laboratory Correlates Analyzed Using Paired T-tests|Relevant laboratory correlates will be compared between responders and non-responders using the Wilcoxon rank sum test. The association between the presence or absence of RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorphisms in the RET gene and response, will be analyzed using Fisher’s exact test. The correlative and genetic data will also be entered as covariates (univariate analyses only due to the small sample size) in a Cox regression model of progression-free survival.|Baseline to 2 years|||||||
1267333|NCT00381641|Secondary|Time to Progression or Death Evaluated Using the RECIST||Time from start of treatment to time of progression or death of any cause, assessed up to 10 years||||Months||95% Confidence Interval|Median
1267334|NCT00381641|Secondary|Overall Survival|Kaplan-Meier curves will be generated and 95% confidence intervals will be derived for median overall survival.|Up to 10 years||||Months||95% Confidence Interval|Median
1267335|NCT00381641|Secondary|Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0|Any grade toxicity of any type, regardless of attribution|From time of first treatment with sunitinib, assessed up to 2 years||||Participants|||Count of Participants
1267336|NCT00381641|Primary|Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 2 years||||Participants|||Count of Participants
1267337|NCT00381628|Primary|The Number of Participants With Blood and Sputum Samples Collected|Blood and sputum samples for general science research collaborators|Baseline|These samples were to be distributed to research collaborators and were not part of a clinical trial. These samples were not analyzed for a specific outcome.|||Participants|||Count of Participants
1267338|NCT00381615|Secondary|Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age|Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population.|At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.||||Percentages of Subjects||95% Confidence Interval|Number
1267339|NCT00381615|Secondary|Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age|Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age.|At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.||||Percentages of Subjects||95% Confidence Interval|Number
1267340|NCT00381615|Secondary|Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age|Geometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age.|1 month after first vaccination||||Ratio||95% Confidence Interval|Geometric Mean
1267341|NCT00381615|Primary|Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.|Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection.|At baseline (pre-vaccination) and 30 days after the third vaccination||||Ratio||95% Confidence Interval|Geometric Mean
1267342|NCT00381615|Primary|Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.|Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.|30 days after the third vaccination|Analysis was performed on the Per Protocol Set (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Percentage of Subjects||95% Confidence Interval|Number
1267343|NCT00381615|Primary|Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study|Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.|||Number of subjects|||Number
1267344|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.|||Number of subjects|||Number
1267561|NCT00379912|Secondary|Quality of Life|Data for this outcome measure was not collected or analyzed due to the termination of the study|24 months|||||||
1267562|NCT00379912|Secondary|Duration of Significant Responses|Data for this outcome measure was not collected or analyzed due to the termination of the study.|24 months|||||||
1267345|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.|||Number of subjects|||Number
1267346|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.|||Number of subjects|||Number
1267347|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1267348|NCT00381615|Secondary|Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age|Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination.|pre-first vaccination and 1 month after first vaccination|Analysis was performed on the PP set after booster vaccination.|||Percentage of subjects||95% Confidence Interval|Number
1267349|NCT00381615|Secondary|Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination|Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age.|30 days after the second vaccination and 1 month after fourth (booster) vaccination|Analysis was performed on the PP set.|||ratios||95% Confidence Interval|Geometric Mean
1267350|NCT00381615|Secondary|Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ|Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population.|pre-first vaccination and 1 month after first vaccination|Analysis was performed on the PP set.|||titers||95% Confidence Interval|Geometric Mean
1267351|NCT00381615|Secondary|Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age|Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination.|prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination|Analysis was performed on the PP set.|||titers||95% Confidence Interval|Geometric Mean
1267352|NCT00381615|Primary|Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.|Baseline and one month after third-dose of infants series|Analysis was performed on the PP set.|||titers||95% Confidence Interval|Geometric Mean
1267353|NCT00381615|Secondary|Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination|Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination.|1 month after first vaccination|Analysis was performed on the PP set.|||Percentage of subjects||95% Confidence Interval|Number
1267354|NCT00381615|Primary|Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization|Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.|Baseline and one month after third-dose of infants series|Analysis was performed on the per protocol (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Percentage of subjects||95% Confidence Interval|Number
1267366|NCT00381381|Secondary|Neuropsychiatry Inventory (NPI)|NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.|26 weeks||||Units on Scale||Standard Deviation|Mean
1268398|NCT00372775|Secondary|Overall Survival (OS)|OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.|Baseline until death (up to 1 year)|ITT. In the absence of confirmation of death, survival time was censored to last date of known contact.|||Months||95% Confidence Interval|Median
1267355|NCT00381563|Secondary|Change in WOMAC Function Scale|The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."|||units on a scale change from baseline||95% Confidence Interval|Mean
1267356|NCT00381563|Primary|Change in WOMAC Pain Scale|The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."|||units on a scale change from baseline||95% Confidence Interval|Mean
1267357|NCT00381563|Primary|Change in Pain on the VIsual Analog Scale (VAS)|The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst).The visual analog scale (VAS) pain ranges from 0-100|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."|||change in units on a scale from baseline||95% Confidence Interval|Mean
1267358|NCT00381550|Primary|Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0||Up to 4 years||||participants|||Number
1267359|NCT00381550|Primary|Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation|Bone marrow aspiration and biopsies were performed prior to treatment, during week 3 of the first cycle, at the time of hematologic recovery from all cycles of therapy (defined as neutrophil count >500/mm3 and platelets >20,000/mm3 independently of transfusion), or at any time that leukemia regrowth was suspected. The overall response rate was defined as complete remission, partial remission, or hematologic improvement, lasting for ≥30 days. Given the different subsets of diseases, standardized response criteria were used for CMML (the Myelodysplastic Syndrome International Working Group criteria),33 CMML transforming to acute myeloid leukemia (standard AML response criteria) , accelerated MPN (Giles et al.), and transformation of MPN to secondary AML (Mascarenhas et al.).|Up to 4 years||||participants|||Number
1267360|NCT00381485|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)|Baseline was the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0 = no awakenings to 1 = awakenings every night. The comparison was for MF/F versus placebo. Standard deviation was pooled.|12-week Treatment Period|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).|||Proportion of nights||Standard Deviation|Least Squares Mean
1267361|NCT00381485|Secondary|Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The AQLQ(S) Total score was the mean of the individual 32 questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).|||Units on a Scale||Standard Deviation|Least Squares Mean
1267362|NCT00381485|Secondary|Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The ACQ Total score was the mean of the individual seven questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).|||Units on a Scale||Standard Deviation|Least Squares Mean
1267363|NCT00381485|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).|||Liter x hour||Standard Deviation|Least Squares Mean
1267364|NCT00381381|Primary|CERAD-K|CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.|26 weeks||||Second||Standard Deviation|Mean
1267365|NCT00381381|Secondary|GDS-K (Geriatric Depression Scale-Korean) Score After Treatment|GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.|26 weeks||||Units on Scale||Standard Deviation|Mean
1267807|NCT00377962|Secondary|Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)||Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Participants|||Number
1267367|NCT00381381|Primary|CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer’s Disease)|CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).|26 weeks||||Units on Scale||Standard Deviation|Mean
1267368|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.|Week 48|Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)|||x10^6 Cells/L||Standard Error|Mean
1267369|NCT00381303|Primary|Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex|TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.|Week 48|TLOVR non-virologic failure (VF) censored|||participants|||Number
1267370|NCT00381303|Secondary|Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)|Last Observation Carried Forward (LOCF) imputation method applied.|Week 48|ITT LOCF|||x10^6 cells/L||Standard Error|Mean
1267371|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)|Week 48|Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)|||x10^6 cells/L||Standard Error|Mean
1267372|NCT00381303|Secondary|Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values|Observed obsevations have no imputation methods applied.|Baseline, Week 48|ITT|||x10^6 cells/L||Standard Error|Mean
1267373|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA|"The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)~TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards."|Week 48|Etravirine-TMC125 (ETR) Subgroup [TLOVR Non-virologic Failure (VF) Censored]|||participants|||Number
1267374|NCT00381303|Secondary|Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race|TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.|Week 48|TLOVR Non-virologic Failure(VF) Censored|||participants|||Number
1267375|NCT00381303|Secondary|Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)|Week 48|ETR Subgroup- Intention to Treat population (ITT)|||participants|||Number
1267376|NCT00381303|Secondary|Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race|Intention to Treat population (ITT)|Week 48|ITT|||participants|||Number
1267377|NCT00381303|Primary|Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex|TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability|Week 48|Intention to Treat (ITT)|||participants|||Number
1267378|NCT00381238|Secondary|Number of Participant's With Hematology Parameters of Clinical Concern|Participant data for clinical concern hematology parameters, were reported for hematocrit (Hct) (unit:1): low concern (LC) and high concern (HC) values as 0.8 and 1.2 respectively, hemoglobin (Hb) (unit: gram per deciliter): LC and HC values as value for female (F) 10 (AB) , value for male (M) 11; and value for F 16.5 (AB), value for M 18 respectively; lymphocytes absolute(LA) (unit: giga cells per litre [GI/L]) : LC and HC value as 0.75 and 1.5 respectively; monocytes absolute (MA) (unit: GI/L) LC and HC value as 0.75 and 2 respectively, platelet count (PC) (unit: x103/mm3): LC and HC value as 100 (AB) and 500(AB) respectively, red blood cell count (RBC) (unit: x106 micro litre): LC and HC value as 0.8 and 1.2 respectively, segmented neutrophils absolute (SNA) (unit: GI/L) LC and HC value as 0.75 and 1.3 respectively, total neutrophils absolute (TNA) (unit : GI/L) LC and HC value as 0.75 and 1.5 respectively; White blood cell (WBC) (unit: GI/L) LC and HC value as 3 and 15.|Up to Wk 50|All subjects population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||participant|||Number
1267379|NCT00381238|Secondary|Number of Participants With Clinical Chemistry Parameters of Clinical Concern-lipids|Participant data for clinical concern lipid parameters for Total cholesterol, high density lipoprotein, low density lipoprotein, triglycerides was to be collected. However this data was not collected.|Up to Wk 50|All subject population. The data for 'The number of participants with clinical chemistry parameters of clinical concern- Lipids' was not collected.||||||
1267380|NCT00381238|Secondary|Number of Participants With Clinical Chemistry Parameters of Clinical Concern|The data for participants for clinical parameters, with values only of potential clinical concern (PCI) were reported for creatine, creatinine kinase(CK), urea and glucose. Creatinine(unit: micromoles per litre) : low concern and high concern values were considered as 22 absolute value (AB) (<50% lower limit of RR ) and 155 (AB) (>125% upper limit of RR) respectively. CK (unit: international unit per litre ): low concern value and high concern values was none and 1.25 respectively. Glucose (unit: millimole per litre): low concern and high concern values were considered as 3.6 (AB) and 7.8 (AB) respectively.|Up to Wk 50|All subjects population. 'n’ is participants available at the particular time of assessment which were included in analysis.|||participants|||Number
1267808|NCT00377962|Secondary|Mean Days of Hospitalization From Baseline to End of Study (Month 24)||Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Days||Standard Deviation|Mean
1267381|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs- Weight|The weight for the participant, was measured without wearing shoes and with light clothing. There was no particular RR, reported for weight; however, the increase from baseline was reported to be >=7 % and the decrease also reported as >=7 %. The values as of potential clinical concern were ‘both’ outside of RR, or met a change from baseline criterion.|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||kilograms||Standard Deviation|Mean
1267382|NCT00381238|Secondary|Number of Participants With Vital Signs of Clinical Concern.|The data for number of participants with vital sign data, outside the range of potential clinical concern for SBP, DBP, HR and body weight were reported. The values as of potential clinical concern were ‘both’ outside of reference range or met a change from baseline criterion. The RR, for SBP was 90-140 mmHg for which the increase from baseline was reported to be >= 40 mmHg and decrease from baseline reported as >=30 mmHg; the RR for DBP was 50-90 mmHg for which the increase from baseline was reported to be >= 30 mmHg and decrease from baseline reported as >=20 mmHg; and the RR, for HR was 50-100 bpm for which the increase from baseline was reported to be >= 30 bpm and the decrease from baseline reported as >=30 bpm. The data of number of participants with > clinical concern range (CCR) or < CCR were reported.|Up to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||participants|||Number
1267383|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs-heart Rate (HR)|The HR for the participant’s, were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The HR was measured in beats per minute (bpm).|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||bpm||Standard Deviation|Mean
1267384|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure|Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||mmHg||Standard Deviation|Mean
1267385|NCT00381238|Secondary|Number of Participants With AE of Peripheral Edema by Grade|Participants with AE of peripheral edema were evaluated. The test was performed by firmly pressing the thumb anterior to the participants ankle until further pressure produced no greater indentation. The depth of the pit was estimated and it was graded using below 5 point scale; where estimated depth of indentation corresponded to a particular grade (G). G 0 as depth of <1 millimeter (mm); G1 as depth of 1-2 mm; G2 as depth of 3-5 mm; G3 as depth of 6-10 mm; and G4 as depth of > 10 mm. The data for only the participants who had peripheral edema on more than one visit, then their most severe G were presented.|Up to Wk 50|All subject population|||participants|||Number
1267386|NCT00381238|Secondary|Number of Participants With SAEs|An SAE, is any untoward medical occurrence, that at any dose may result in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, is congenital anomaly or birth defect, and medically important events. The number of participants with any SAE, were reported.|From start of study medication (Wk 0) to Wk 50|All subject population|||participants|||Number
1267387|NCT00381238|Secondary|Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score|The MMSE, is a score scale which consists of 11 tests of orientation (to time and place), memory (recent and immediate), concentration, language and praxis. The scoring ranged from 0 to 30, with lower scores indicative of greater cognitive impairment (more severe disease) and higher scores indicative less cognitive impairment (less severe disease). The total score was calculated by summing the scores from each of the tests. The investigator questioned the participants individually with set of questions and scored the participant, based on his performance. The baseline was defined as Wk 0. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.|From baseline to Wk 48|Intent to treat (ITT). The ITT population consisted of all participants in the safety population who also had at least one post-dose efficacy assessment within this study.|||score on scale||Standard Deviation|Mean
1267388|NCT00381238|Primary|Number of Participants With Adverse Events (AE's)|An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study drug or withdrawal were reported.|From start of study medication (Wk 0) to Wk 50|All subject population, is defined as all the participants who received at least one dose of study drug.|||participants|||Number
1267389|NCT00381095|Secondary|Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28|ECOG - assessed disease progression and how disease affected the daily living abilities of the participant and determined appropriate treatment and prognosis. Graded 0 (fully active able to carry on all pre-disease performance without restrictions) to 5 (dead). Change was day 28 minus baseline.|Baseline, Day 28 or ET|Data not analyzed due to early study termination.|||Scores on a scale||Standard Deviation|Mean
1267390|NCT00381095|Secondary|Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28|OR-SDS included OR-SDS individual items by dimension of frequency (rarely to almost constantly), severity (slight to very severe), and degree of bother (not at all to very much), number of episodes of retching/vomiting, OR-SDS dimension composite and overall composite scores. Change was scores at occurance minus score at baseline.|Baseline, Day 14, Day 28 or ET|Data not analyzed due to early study termination.|||Units on a scale||Standard Deviation|Mean
1267391|NCT00381095|Secondary|Patient Global Impression of Change (PGIC)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Weeks 2 and 4 or ET|ITT; LOCF; n=number of evaluable participants analyzed at each time point; N= the number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
1267392|NCT00381095|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4|HADS: participant rated questionnaire with 2 subscales. HADS-Anxiety assessed generalized anxiety (anxious mood/ restlessness/ anxious thoughts/panic attacks); HADS-Depression assessed lost interest/diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items which ranged from 0 (no presence of anxiety or depression) to 3 (severe feeling anxiety/depression). Total 0-21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Change was week x minus baseline.|Baseline, Week 4 or ET|ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed; individual symptoms not analyzed|||Units on a scale||Standard Deviation|Mean
1267393|NCT00381095|Secondary|Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28|IR and SR formulations separately and combined. Change was day x minus baseline.|Baseline, Day 0 through Day 28 or ET|Data not analyzed due to early study termination.|||mg/day||Standard Deviation|Mean
1267394|NCT00381095|Secondary|Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28|Change from baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.|Baseline, Day 0 through Day 28 or ET|Data no analyzed due to early study termination.|||milligrams/day (mg/day)||Standard Deviation|Mean
1267395|NCT00381095|Secondary|Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4|Change from baseline in daily average pain score NRS 0 (no pain) to 10 (pain as bad as you can imagine) for pain intensity over past 24 hours recorded every evening before bedtime. Change was week x average minus baseline average.|Baseline, Weeks 1, 2, 3 and 4 or ET|Data not analyzed due to early study termination.|||Units on a scale||Standard Deviation|Mean
1267396|NCT00381095|Secondary|Change From Baseline in mBPI-sf Interference Index Score at Week 4|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Change was score at each observation minus baseline score.|Baseline, Week 4 or ET|ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
1267397|NCT00381095|Secondary|Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4|m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index was the mean of item scores 1, 2, 3, and 4 (worst, least, average and current pain scores). Change was scores at observation minus scores at baseline.|Baseline, Week 4 or ET|ITT; LOCF= Last observation carried forward; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
1267398|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary 14 days after dosing stabilized (fixed dosing date) up to Day 28. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET|ITT; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
1267399|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, Day 1 to End of Dose Adjustment or ET|ITT; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
1267400|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain, Days 1 Through 28|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, Days 1 through 28 or ET|ITT; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
1267401|NCT00381095|Primary|Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28|DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.|Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)|Intent-To-Treat population (ITT): all randomized participants for whom at least one post-baseline efficacy evaluation was obtained; N= the number of participants with evaluable data analyzed; n= number of participants with evaluable data at the specific time point.|||Units on a scale||Standard Deviation|Mean
1267402|NCT00381043|Secondary|% Compliant With Medication|% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.|12 weeks||||percentage of participants|||Number
1267403|NCT00381043|Secondary|Clinical Global Impression Scale|Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill|12 weeks||||units on a scale||Standard Deviation|Mean
1267404|NCT00381043|Secondary|% Heavy Drinking Days During Trial|% of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial.|12 weeks||||percentage of heavy drinking days||Standard Deviation|Mean
1267405|NCT00381043|Secondary|Percent With Complete Abstinence|% of subjects with no drinking during the 12 week treatment trial|12 weeks||||percentage of participants|||Number
1267406|NCT00381043|Primary|Percent Days Abstinent|%Days without any alcohol consumption over the treatment period|12 weeks||||percentage of days||Standard Deviation|Mean
1267407|NCT00381043|Primary|% Dropout|Percentage of participants who dropped out of study by drug condition|12 weeks||||percentage of participants|||Number
1267408|NCT00381043|Secondary|Retention|Number of individuals retained in the trial by acamprosate vs placebo group|12 weeks||||participants|||Number
1267409|NCT00381004|Primary|Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.|Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)</=4x10^9/L, Hb>11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC</=4x109/L + Hb>11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease.|Baseline to 6 Months||||Participants|||Number
1267410|NCT00381004|Secondary|Number of Participants Progression-free|Participants progression free as measured at six months following start of treatment. Criteria for Progressive Disease (PD): Peripheral blood: 50% increase in ALC with a level > 10 x 109/L on at least 2 occasions 2 weeks apart. Tumor: An increase of a lesion by 50% over the size present at entry on study or for patients who respond, the size at the time of maximum regression and/or the appearance of new areas of malignant disease. Reappearance of bone marrow disease. A deterioration in performance status or increasing symptoms do not constitute disease progression.|6 months or until disease progression if earlier||||participants|||Number
1267411|NCT00381004|Primary|Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.|Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)</=4x10^9/L, Hb>11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC</=4x109/L + Hb>11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease.|Baseline to 6 Months||||Percentage of Participants|||Number
1267412|NCT00380978|Secondary|Vomiting|Vomiting during labor analgesia|Vomiting at second analgesia request||||participants|||Number
1267413|NCT00380978|Secondary|Neonatal Outcome (APGAR Score < 7 at 5 Minutes)|Infant's Apgar scores measured at 5 minutes of life and were assigned by nurses and pediatricians responsible for neonatal assessment. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing the five values. The categories are skin color, pulse, reflex to stimulation, muscle tome, and breathing. The test was done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 3 and below are generally regarded as critically low, 4 to 6 fairly low, and 7 to 10 generally normal.|APGAR score at 5 minutes||||participants|||Number
1267414|NCT00380978|Secondary|Nausea|Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting.|At second analgesia request||||participants|||Number
1267415|NCT00380978|Secondary|Analgesia Efficacy|Patients were asked to rate their average pain score using an 11-point verbal rating score (VRS)for pain (0 - 10: 0= no pain, 10= worst pain imaginable) between 1st and 2nd analgesia request.|At first and second analgesia requests||||Scores on a scale||Inter-Quartile Range|Median
1267416|NCT00380978|Secondary|Indication for Cesarean Delivery|The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.|At time of decision for delivery|Number of cesarean deliveries|||participants|||Number
1267417|NCT00380978|Secondary|Duration of Labor|Labor was induced by initiating an oxytocin infusion or by infusing extra-amniotic saline followed by oxytocin. All participants had continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol.|Initiation of induction of labor to time of delivery|Per protocol|||minutes||Inter-Quartile Range|Median
1267418|NCT00380978|Secondary|Instrumented Vaginal Delivery|The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.|At time of decision for delivery|Per protocol - subjects that delivered vaginally|||participants|||Number
1267419|NCT00380978|Primary|Delivered by Cesarean Section|The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.|Time form initiation of labor analgesia to delivery (up to 24 hours)|Analysis per protocol. 10 did not receive intervention in combined spinal epidural group and 2 in the systemic analgesia group|||participants|||Number
1267420|NCT00380874|Primary|Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days).|Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)|Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained; Last Observation Carried Forward (LOCF): last recorded cycle. Primary analysis timeframe: 10 days of paresthesia scores from the onset of chemotherapy to the last cycle of chemotherapy (LOCF).|||score on scale||Standard Error|Least Squares Mean
1267804|NCT00378014|Secondary|Incidence of the Need for a Change in the Immunosuppressive Regimen|The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).|Month 11|ITT|||Percentage of participants|||Number
1267421|NCT00380874|Secondary|Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms|Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime.|Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint|ITT population, subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||participants|||Number
1267422|NCT00380874|Secondary|Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours.|Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint|ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||score on scale||Standard Error|Least Squares Mean
1267423|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9, LOCF cycle endpoint|ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||score on scale||Standard Error|Least Squares Mean
1267424|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9, LOCF cycle endpoint|ITT population, subjects with at lest 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||score on scale||Standard Error|Least Squares Mean
1267425|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9|Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||score on scale||Standard Error|Least Squares Mean
1267426|NCT00380861|Secondary|Single Leg Active Flexion at 2 Weeks, 6 Weeks, 6 Months and 12 Months.||2 weeks, 6 weeks, 6 months and 12 months|||||||
1267427|NCT00380861|Primary|Knee Society Passive Flexion at 6 Months|The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.|6 months||||Degrees of passive flexion||Standard Deviation|Mean
1267428|NCT00380861|Secondary|Subject Satisfaction||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
1267429|NCT00380861|Secondary|Crepitus||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
1267430|NCT00380861|Secondary|Ability to Perform Activities||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
1267431|NCT00380861|Secondary|Knee Pain||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
1267432|NCT00380861|Secondary|KOOS Score||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
1267433|NCT00380861|Secondary|AKS Score||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
1267434|NCT00380861|Secondary|Effect of Subject Demographics and Anthropometrics on ROM||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
1267435|NCT00380861|Secondary|Single Leg Passive Flexion at All Scheduled Follow-up Visits: 2 Weeks, 6 Weeks, 6 Months and 12 Months.||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
1267436|NCT00380718|Secondary|Time to Tumor Progression|Time to documented tumor progression was defined as the time from the date of enrollment to the first date of documented disease progression. Time to documented disease progression was censored at the date of death for participants who had not had documented disease progression. Otherwise, the censoring rules were the same as for Progression-Free Survival.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.|||months||95% Confidence Interval|Median
1267437|NCT00380718|Secondary|Time to Treatment Failure|Time to treatment failure was define as the time from the date of enrollment to the date of the first of the following events: objective disease progression, death due to any cause, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. Time to treatment failure for participants who were still participating in the study without treatment failure at the time of analysis were treated as censored at the date of the last tumor assessment.|baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. One patient was censored as he/she was alive at time of analysis.|||months||95% Confidence Interval|Median
1271441|NCT00349466|Secondary|Tear Meniscus (TM) Height|Indicator of tear volume. TM was recorded on a scale from 0-3, with 0=none, 1=trace, 2=normal, and 3=high.|12 weeks|||||||
1267438|NCT00380718|Secondary|Duration of Response|Duration of overall tumor response was measured from the time of first documentation of complete response or partial response (whichever status was first recorded) until the date of progression-free survival, with censoring defined as: disease had not progressed, treatment was discontinued due to undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.|time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Participants who received study drug and who had either a complete or partial response to treatment. Three participants were censored as they were alive at the time of analysis.|||months||Full Range|Median
1267439|NCT00380718|Secondary|Progression-Free Survival (PFS)|Time to PFS was defined as the time from the date of enrollment to the date of the first of the following events: objective disease progression or death due to any cause. Survival time frame includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment. Patients were censored if their disease had not progressed, treatment was discontinued due to an undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.|baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.|||months||95% Confidence Interval|Median
1267440|NCT00380718|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last follow-up visit.|baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.|||months||Full Range|Median
1267441|NCT00380718|Secondary|Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])|DCR was defined as the proportion of best overall response of CR, PR, and SD. DCR=(CR+PR+SD)/Number of participants. Response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|"Number of participants who received at least one dose of study drug. Participants who were classified as Unknown were considered nonresponders rather than missing."|||proportion of participants||95% Confidence Interval|Mean
1267442|NCT00380718|Primary|Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])|"The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments."|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|"Number of participants who received at least one dose of study drug. Participants who were classified as Unknown were considered nonresponders rather than missing."|||proportion of responders||95% Confidence Interval|Mean
1267443|NCT00380692|Secondary|Cytochrome P450 2D6 Genotype|Genotype characterization was used to determine participants' metabolic status.|baseline|All randomized participants.|||participants|||Number
1267444|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times|Task is the same as described in Outcome Measure #19. Mean reaction times (RTs) are computed for correct responses to compatible and incompatible flankers, respectively.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
1267445|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates|Measures ability to neglect stimuli interfering with predefined stimulus-response coupling. Child presented with displays of 9 colored squares. Child responds to color of central square by pressing left mouse key when blue, and right mouse key when yellow. Part 1 (40 trials), surrounding squares may be same color (compatible) or different (neutral). Part 2 (80 trials), in 50% of trials, surrounding squares have color corresponding to predefined key press for other hand (incompatible). Error rates are percentages of errors in response to compatible and incompatible signals, respectively.|Baseline, 8 weeks|Number of participants with baseline and one non-missing postbaseline value at visit.|||error rate (percentages)||Standard Deviation|Mean
1267446|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates|Measures inhibition of pre-potent responses. 24 Go signals (open squares) are presented, randomly mixed with 24 No-Go signals (closed squares). Subjects are required to press a key if a Go signal (target) appears on the screen but to withhold a response if they see a No-Go signal. Error rate is the percentage of key presses to No-Go signals/total number of trials X 100.|Baseline, 8 weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||error rate (percentage)||Standard Deviation|Mean
1267447|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement|A complex visuo-motor flexibility task that measures eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Stability is within subject variability of mean distance between cursor and target.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.|||millimeters||Standard Deviation|Mean
1267460|NCT00380692|Secondary|ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|28 weeks|Randomized participants with a value at timepoint.|||units on a scale||Standard Deviation|Mean
1267448|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy|A complex visuo-motor flexibility task that aims at measuring eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Accuracy is the mean distance between the mouse cursor and the moving target.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.|||millimeters||Standard Deviation|Mean
1267449|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #14. Standard deviations of reaction times (RT) assess intraindividual variability in RT referring to the two conditions creating hits and correct rejections as mentioned in Outcome Measure #14.|Baseline, 8 weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
1267450|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections|Memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to remember (one animal). A “yes” is required whenever the target is part of displayed set of 4 animals. Load 2 has 2 animals. A “yes” is required whenever one of the animals appears in successively displayed sets of 4 animals. Targets are present in 50% of the trials. Reaction time (RT) for hits is mean RT of correct “yes” responses to targets. RT correct rejections are mean RTs of correct “no” responses when target was missing.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
1267451|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates|The memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to identify (e.g., an animal). A “yes” is required whenever the target is part of the displayed set of four stimuli (all animals). Load 2 has 2 targets. Whenever 1 of the targets appears in the successively displayed sets of four animals, a “yes” is required. Targets are present in 50% of trials. Error rates are the percentages of errors made in each task condition, based on the number of errors/total number of trials X 100.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||error rate (percentage)||Standard Deviation|Mean
1267452|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #10. Standard deviations of reaction times (RT) assess intraindividual variability in RT and refer to the same conditions as those for mean reaction times described in Outcome Measure #11.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
1267453|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #10. Reaction times (RT) for hits are mean RTs of correct responses to relevant targets. RTs for correct rejections are mean RTs for correct rejections are mean RTs for correct no responses to irrelevant targets and relevant nontargets.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
1267454|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates|Focused attention assessed distractibility. Child needs to identify a specific target (eg, Cherry); non-target is any other fruit. Child presses “yes” when target occurs in relevant position (eg, one of vertical positions on diamond). Child presses “no” when target is absent, or when target appears on horizontal position (irrelevant target). Error rates are percentage of missing relevant targets and percentage of false alarms in response to (irr)relevant (non)targets based on number of errors/total number of trials X 100.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||error rate (percentage)||Standard Deviation|Mean
1267455|NCT00380692|Secondary|Nijmeegse Ouderlijke Stress Index (NOSI) Total Score|The NOSI contains 123 items to be completed by the primary caregiver. Individual item scores range from 1 (completely agree) to 6 (completely disagree). Total scores range from 123 to 738.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.|||units on a scale||Standard Deviation|Mean
1267456|NCT00380692|Secondary|General Health Questionnaire (GHQ) Total Score|Parental distress is measured with the GHQ. The raw total score (based on 0-0-1-1 scoring system) can be used as an overall index of psychological distress, ranging from 0 to 12 with higher scores indicating more distress.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.|||units on a scale||Standard Deviation|Mean
1267457|NCT00380692|Secondary|Children's Social Behavior Questionnaire (CSBQ) Total Score|CSBQ is filled out by parents and consists of 49 items. Items are rated in an ordinal rather than a discrete fashion in order to establish the extent to which problems are present. The CSBQ consists of six subscales. Individual item scores range from 0=does not apply to 2=applies clearly. Total score ranges from 0 to 98.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.|||units on a scale||Standard Deviation|Mean
1267458|NCT00380692|Secondary|Aberrant Behavior Checklist (ABC)|The ABC is a 58-item informant-based scale comprised of five subscales (Irritability [15 items], Lethargy [16], Stereotypic Behaviors [7], Hyperactivity [16], Inappropriate Speech [4]). Individual item scores range from 0 (no problem) to 3 (severe problem). Subscale scores are total of individual item scores in subscale: Irritability (0-45); Lethargy (0-48); Stereotypic (0-21); Hyperactivity (0-48); Inappropriate Speech (0-12).|Baseline, 8 weeks, 28 weeks|Randomized participants with values at timepoint.|||units on a scale||Standard Deviation|Mean
1267459|NCT00380692|Secondary|Sleep Measure Scale|10-item parent-based scale assessing sleep problems (6 point Likert scale). Scores: Difficulty falling asleep (1-6); Quality of sleep (3-18); Functional outcome (6-36). Lower scores indicate higher problems with item. Open-ended items: Time to fall asleep (1 [0-15 minutes] to 5 [>1 hour]); Total hours (numbers associated with hours of sleep).|Baseline, 8 weeks, 28 weeks|Randomized participants with a value at timepoint.|||units on a scale||Standard Deviation|Mean
1267499|NCT00380250|Secondary|Month 3 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 3|ITT with LOCF|||Scale score||Standard Deviation|Mean
1267461|NCT00380692|Secondary|Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Baseline, 8 weeks, 28 weeks|Number of randomized participants who had a value at timepoint.|||units on a scale||Standard Deviation|Mean
1267462|NCT00380692|Secondary|Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|8 weeks, 28 weeks|Number of randomized participants with values at timepoint.|||units on a scale||Standard Deviation|Mean
1267463|NCT00380692|Primary|ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline and 8 weeks|Number of randomized participants with a value at baseline and 8 week endpoint. Last Observation Carried Forward analysis.|||units on a scale||Standard Deviation|Mean
1267464|NCT00380588|Other Pre-specified|Survival Time|Data of patients lost to follow-up were censored at the last date of confirmation of their survival.|baseline to date of death due to any cause (up to 2 years)||||months||95% Confidence Interval|Median
1267465|NCT00380588|Secondary|Progression Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline to measured progressive disease (up to 2 years)|Number of patients who received at least one dose of study drug.|||months||95% Confidence Interval|Median
1267466|NCT00380588|Secondary|Tumor Response|"Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 2 years)|Number of patients who received at least one dose of study drug.|||participants|||Number
1267467|NCT00380588|Primary|Percentage of Patients Alive at 1 Year (1-Year Survival Rate)|Percentage of patients alive at 1 year.|1 year|Number of patients who received at least one dose of study drug.|||percentage of participants|||Number
1267468|NCT00380393|Secondary|Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells|T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).|At Month 3|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||cells/million||Inter-Quartile Range|Median
1267469|NCT00380393|Secondary|Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells|T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).|At Month 3|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||cells/million||Inter-Quartile Range|Median
1267470|NCT00380393|Secondary|Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells|T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).|Prior to vaccination (Day 0)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||cells/million||Inter-Quartile Range|Median
1267471|NCT00380393|Secondary|Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells|T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).|Prior to vaccination (Day 0)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||cells/million||Inter-Quartile Range|Median
1267472|NCT00380393|Secondary|Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).|At Day 0 and at Month 3|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
1267473|NCT00380393|Secondary|Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
1267474|NCT00380393|Secondary|Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades|Definition for toxicity grading for creatinine were: Normal Creatinine = ≤ 60 micromols per liter (μmol/L); Grade 1 Creatinine = 1.1 to 1.5 x ULN; Grade 2 Creatinine = 1.6 to 3.0 x ULN.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1267834|NCT00377832|Secondary|Rate of Determination of Non-reassuring Fetal Status|Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.|Labor--up to 24 hours||||participants|||Number
1267475|NCT00380393|Secondary|Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades|Definition for toxicity grading for ALT were: Normal ALT = ≤ 60 international units per liter (IU/L); Grade 1 ALT = 1.1 to 2.5 x Upper Limit of Normal (ULN); Grade 2 ALT = 2.6 to 5.0 x ULN.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1267476|NCT00380393|Secondary|Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades|Definitions for toxicity grading for platelets were: Normal Platelets = ≥ 75 x 10^3 cells/μL; Grade 1 Platelets = 50 to 74 x 10^3 /μL; Grade 2 Platelets = 25 to 49 x 10^3 /μL; Grade 3 Platelets = < 25 x 10^3 /μL.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1267477|NCT00380393|Secondary|Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades|Definitions for toxicity grading for WBC were: Normal WBC = ≥ 4.0 x 10^3 cells per microliters (cells/μL) or < 17 x 10^3 cells /μL; Grade 1 WBC = 2.5 to 4.0 x 10^3 cells/μL.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1267478|NCT00380393|Secondary|Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades|Definitions for toxicity grading for hemoglobin were: Normal Hemoglobin = equal to or above (≥) 8.0 g/dL; Grade 1 Hemoglobin = under (<) 8.0 g/dL and above (>) 6.0 g/dL.; Grade 2 Hemoglobin = under (<) 6.0 g/dL.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1267479|NCT00380393|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (Day 0 - Month 14)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1267480|NCT00380393|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Days 0-29) post-vaccination follow-up period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1267481|NCT00380393|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
1267482|NCT00380393|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
1267483|NCT00380393|Secondary|Haemoglobin Values at Cross-Sectional Visit|Haemoglobin values are expressed in grams per deciliter (g/dL).|At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||g/dL||Standard Deviation|Mean
1267484|NCT00380393|Secondary|Geometric Mean Density of Asexual P. Falciparum Parasite|Estimates of asexual P. falciparum parasite density were made at the investigator's sites according to laboratory standard operating procedures. Parasite density was presented as a geometric mean (GMean), expressed in parasite per microliters (μL).|At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||parasites/μL||95% Confidence Interval|Geometric Mean
1267485|NCT00380393|Secondary|Number of Subjects Positive for P. Falciparum Parasitaemia||At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||Participants|||Count of Participants
1267500|NCT00380250|Secondary|Month 2 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
1267501|NCT00380250|Secondary|Month 3 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|ITT with LOCF|||Scale score||Standard Deviation|Mean
1267486|NCT00380393|Secondary|Multiple Events of Malaria Meeting the Secondary Case Definition|Multiple episodes of malaria meeting the secondary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia > 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of secondary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.|Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||PYAR|||Number
1267487|NCT00380393|Secondary|Multiple Events of Malaria Meeting the Primary Case Definition|Multiple episodes of malaria meeting the primary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia > 25000 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of primary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.|Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||PYAR|||Number
1267488|NCT00380393|Secondary|Frequency of First Case Malaria Meeting the Secondary Case Definition|The first case of malaria meeting the secondary case definition was defined as the first or only episodes with the presence of P.falciparum asexual parasitemia > 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.|Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||PYAR|||Number
1267489|NCT00380393|Primary|Frequency of First Case of Malaria Meeting the Primary Case Definition|The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.|Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||PYAR|||Number
1267490|NCT00380367|Primary|Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. Pre-specified injection site AEs included pain, tenderness, erythema, and swelling. A vaccine-related AE was an AE considered by the investigator to be possibly, probably, or definitely related to the vaccine. All AEs collected on participant’s Vaccination Report Card daily for 14 days after each vaccination (Days 1-15).~The number of participants who experienced ≥1 AE, the number of participants who experienced ≥1 injection site AE, the number of participants who experienced ≥1 systemic AE, and the number of participants who experienced ≥1 vaccine-related AE were reported for the Safety Cohort."|Up to 7 months|Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.|||participants|||Number
1267491|NCT00380367|Primary|Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7|Month 7 HPV competitive Luminex Immunoassay (cLIA) seroconversion rates among participants who received Quadrivalent HPV (Types 6, 11, 16, 18) Late 1 (L1) capsid protein VLP vaccine were reported. The quadrivalent HPV competitive cLIA (v2.0) was used to detect antibody to HPV VLPs serotypes 6, 11, 16, 18 before and after vaccination with the HPV quadrivalent vaccine. Seropositivity cutoffs of the HPV cLIAs were assessed using a panel of sera from participants highly likely to be HPV naïve (children), and from participants who were highly likely to be seropositive. Any sample with a value less than the cutoffs was considered serostatus negative. Samples with values equal to or greater than the cutoff were considered serostatus positive. The cutoffs for the HPV 6, 11, 16, and 18 cLIAs were 20 milli‐Merck units per milli liter (mMU/mL), 16 mMU/mL, 20 mMU/mL, and 24 mMU/mL, respectively.|One month post-dose 3 (Month 7)|Per‐Protocol (P-P) immunogenicity population: All participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were sero-negative at Day 1 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.|||percentage of participants||95% Confidence Interval|Number
1267492|NCT00380250|Secondary|Month 3 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3||||Scale Score||Standard Deviation|Mean
1267493|NCT00380250|Secondary|Month 2 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2||||Scale Score||Standard Deviation|Mean
1267494|NCT00380250|Secondary|Month 1 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1||||Scale Score||Standard Deviation|Mean
1267495|NCT00380250|Secondary|Month 3 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 3|ITT, with LOCF|||BM/week||Standard Deviation|Mean
1267496|NCT00380250|Secondary|Month 2 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 2|ITT, with LOCF|||BM/week||Standard Deviation|Mean
1267497|NCT00380250|Secondary|Month 1 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 1|ITT, with LOCF|||BM/week||Standard Deviation|Mean
1267498|NCT00380250|Secondary|Month 1 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|ITT with LOCF|||Scale score||Standard Deviation|Mean
1267511|NCT00380250|Secondary|Month 1 Responder Rate|"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:~Rescue medication use does not increase during the month as compared to baseline;~No discontinuation during the month due to lack of efficacy;AND~No ratings during the month of Moderately worse or Significantly worse."|month 1 (28 days)|ITT without LOCF|||percent of participants|||Number
1267512|NCT00380250|Secondary|Month 3 Responder Rate|"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:~Rescue medication use does not increase during the month as compared to baseline;~No discontinuation during the month due to lack of efficacy;AND~No ratings during the month of Moderately worse or Significantly worse."|month 3 (28 days)|ITT without LOCF|||percent of participants|||Number
1267513|NCT00380250|Secondary|Month 2 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|month 2 (28 days)|ITT without LOCF|||percent of participants|||Number
1267514|NCT00380250|Primary|Overall Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.~Overall responder: responder for at least 2/3 months"|12 weeks|Intent-to-treat (ITT) without Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
1267515|NCT00380250|Secondary|Quality of Life Change From Baseline|Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase|Change from baseline at 12 weeks|ITT without LOCF|||Scale score||Standard Deviation|Mean
1267516|NCT00380250|Secondary|Month 1 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 1|ITT with LOCF|||Scale score||Standard Deviation|Mean
1267517|NCT00380250|Secondary|Month 1 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline at 28 days|ITT with LOCF|||Scale score||Standard Deviation|Mean
1267518|NCT00380250|Secondary|Month 1 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|ITT with LOCF|||Scale score||Standard Deviation|Mean
1267519|NCT00380250|Secondary|Month 1 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 1|ITT with LOCF|||Scale score||Standard Deviation|Mean
1267520|NCT00380250|Secondary|Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline|SBMs are any bowel movement not associated with rescue medication use.|Change from baseline for month 1|ITT with LOCF|||SBM/week||Standard Deviation|Mean
1267521|NCT00380081|Post-Hoc|Subjective Number of Awakenings After Middle-of-the-Night Awakening|Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as documented by the participant for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population|||number of awakenings||95% Confidence Interval|Least Squares Mean
1267522|NCT00380081|Secondary|Polysomnography Number of Awakenings After Middle-of-the-Night Awakening|Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population|||number of awakenings||95% Confidence Interval|Least Squares Mean
1267523|NCT00380081|Secondary|Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening|Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
1267524|NCT00380081|Secondary|Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening|Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
1267525|NCT00380081|Secondary|Subjective Sleep Onset Latency After Middle-of-the-Night Awakening|Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
1267526|NCT00380081|Secondary|Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening|Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population|||percentage of time asleep||95% Confidence Interval|Least Squares Mean
1267527|NCT00380081|Secondary|Subjective Ability to Function|Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population|||percentage of participants|||Number
1267528|NCT00380081|Secondary|Subjective Level of Refreshed Sleep|Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population|||percentage of participants|||Number
1267529|NCT00380081|Secondary|Subjective Sleep Quality Rating|Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population|||percentage of participants|||Number
1267530|NCT00380081|Other Pre-specified|Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period in a subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
1267531|NCT00380081|Secondary|Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening|The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
1267532|NCT00380081|Other Pre-specified|Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia|Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period in the subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
1267533|NCT00380081|Secondary|Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography|Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent-to-treat population.|||minutes||95% Confidence Interval|Least Squares Mean
1267534|NCT00380081|Secondary|Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes.|Days 1 and 2 for each treatment|Intent to treat population|||participants|||Number
1267535|NCT00380081|Primary|Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent-to-treat population|||minutes||95% Confidence Interval|Least Squares Mean
1267536|NCT00380068|Secondary|Long-term Survival|Defined as not dying during study participation|Baseline to Week 48|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
1267537|NCT00380068|Secondary|Long-term Survival|Defined as not dying during study participation|Baseline to Week 24|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
1267538|NCT00380068|Secondary|Monotherapy Treatment Status|Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment|Baseline to Week 48|Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline.|||Percentage of participants|||Number
1267539|NCT00380068|Secondary|Monotherapy Treatment Status|Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment|Baseline to Week 24|Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline.|||Percentage of participants|||Number
1267540|NCT00380068|Secondary|Failure-free Treatment Status|Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents|Baseline to Week 48|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
1267541|NCT00380068|Secondary|Failure-free Treatment Status|Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents|Baseline to Week 24|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
1267542|NCT00380068|Secondary|Percent of Participants With no Clinical Worsening of PH at Week 48|Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents|Baseline to Week 48|Full analysis set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
1267543|NCT00380068|Secondary|Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24|Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents|Baseline to Week 24|Full analysis set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
1267544|NCT00380068|Secondary|Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale|Change from baseline to Week 48 in the SF-36 health survey physical functioning scale. 10 activities are rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General US population mean and standard deviation. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and standard deviation of 10.|Baseline to Week 48|Full Analysis Set. Last Observation Carried forward. 25 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data.|||Units on a scale||Standard Deviation|Mean
1267589|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267835|NCT00377832|Secondary|Rate of Cesarean Delivery|Rate of cesarean delivery|Labor--up to 24 hours||||participants|||Number
1267545|NCT00380068|Secondary|Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale|Change from baseline to Week 24 in the SF-36 health survey physical functioning scale. 10 activities rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 26 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data.|||Units on a scale||Standard Deviation|Mean
1267546|NCT00380068|Secondary|Change From Baseline to Week 48 in WHO Functional Class|Change from baseline in WHO at Week 48 is expressed as the incidence of participants that improved, had no change or worsened. WHO categories range from 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.|Baseline to Week 48|Full Analysis Set. Observed Data. 3 participants were not analyzed due to lack of post-baseline WHO functional class data.|||Percentage of participants|||Number
1267547|NCT00380068|Secondary|Change From Baseline to Week 24 in WHO Functional Class|Change from baseline in World Health Organization functional class (WHO) at Week 24 is the incidence of participants that improved, had no change, or worsened. WHO categories are 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.|Baseline to Week 24|Full Analysis Set. Last Observation Carried Forward. 3 participants were not analyzed due to lack of post-baseline WHO functional class data.|||Percentage of participants|||Number
1267548|NCT00380068|Secondary|Percent Change From Baseline to Week 48 in BNP||Baseline to Week 48|Full Analysis Set. Observed data. 111 participants were excluded from the analysis due to lack of baseline or Week 48 BNP data.|||Percent change in BNP||95% Confidence Interval|Geometric Mean
1267549|NCT00380068|Secondary|Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP)||Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 10 participants were excluded from the analysis due to lack of baseline or post-baseline BNP data.|||Percent change in BNP||95% Confidence Interval|Geometric Mean
1267550|NCT00380068|Secondary|Change From Baseline to Week 48 in Borg Dyspnea Index|Change from Baseline to Week 48 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.|Baseline to Week 48|Full Analysis Set. Observed data. 114 participants were excluded from the analysis due to lack of Week 48 Borg Dyspnea Index data.|||Units on a scale||Standard Deviation|Mean
1267551|NCT00380068|Secondary|Change From Baseline to Week 24 in Borg Dyspnea Index|Change from Baseline to Week 24 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.|Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline Borg Dyspnea Index data.|||Units on a scale||Standard Deviation|Mean
1267552|NCT00380068|Primary|Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)||Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline 6MWD data.|||meters||Standard Deviation|Mean
1267553|NCT00380029|Secondary|Number of Subjects Experiencing Adverse Events|The incidence of all toxicities observed during neoadjuvant and adjuvant treatment phase.Toxicity will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) 2.0.|4 weeks - 2 years following surgery|All patients enrolled received the full 4-week neoadjuvant course of erlotinib. 12 patients continued on erlotinib in the adjuvant phase for a mean (range) duration of 29 (5-84) weeks.|||Participants|||Count of Participants
1267554|NCT00380029|Secondary|Overall Survival Rate|The number of patients who remained alive and with no evidence of disease at the mean (range) follow-up of 24.8 months (3.0-36.6).|25 months||||Participants|||Count of Participants
1267555|NCT00380029|Secondary|Disease Recurrence and Progression Rates After Cystectomy|To determine disease recurrence/progression rates after cystectomy in patients treated with erlotinib|2 years||||Participants|||Count of Participants
1267556|NCT00380029|Secondary|Pathological Complete Response Rate|Determine the pathological complete response rate (P0 rate) after undergoing radical cystectomy (RC). Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|4 weeks||||Participants|||Count of Participants
1267557|NCT00380029|Primary|EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib|Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer. Gene expression of pre-treatment and post-treatment tumor samples were analyzed to define molecular determinants of response or resistance to epidermal growth factor receptor (EGFR) inhibition. Both in vitro and in vivo EGFR-associated signatures were evaluated on pre-treatment bladder tumors. Candidate molecular determinants of sensitivity to EGFR inhibition were characterized and examined for their ability to predict sensitivity to EGFR inhibitors in vitro.|4 weeks before treatment and 4 weeks post treatment|Only patients with tumor samples with sufficient and high quality RNA were used to generate the in vivo signatures.|||fold change||Full Range|Mean
1267563|NCT00379912|Secondary|Safety Profile of the Modified Dose/Schedule of Azacitidine and Erythropoietin or a Modified Dose of Azacitidine Alone|Full adverse event information is submitted in the record below. A summary of the Significant Toxicities Rate (clinically significant myelosuppression (CTCAE Grade 3 or 4 neutropenia or thrombocytopenia)) over all patients receiving at least 1 dose of study medication at the time of interim analysis is reported in this outcome measure.|24 months|All patients receiving at least 1 dose of study medication at the time of interim analysis.|||percentage of participants||90% Confidence Interval|Number
1267564|NCT00379912|Primary|Overall Response Rate After Six Cycles|"Overall response rate for participants who have completed at least six cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.~Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements."|6 months|Participants completing at least six cycles at the time of analysis.|||percentage of participants responding||90% Confidence Interval|Number
1267565|NCT00379912|Primary|Overall Response After Cycle 3|"Overall response for participants who have completed at least three cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.~Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements."|3 months|Participants completing at least three cycles at the time of analysis.|||percentage of participants responding||90% Confidence Interval|Number
1267566|NCT00379899|Secondary|Percent Change in Ca x P|Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Percentage||Standard Error|Mean
1267567|NCT00379899|Secondary|Absolute Change in Ca x P|Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||(mg/dL)2||Standard Error|Mean
1267568|NCT00379899|Secondary|Percent Change in Phosphorus|Percent change from baseline in serum phosphorus to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Percentage||Standard Error|Mean
1267569|NCT00379899|Secondary|Absolute Change in Phosphorus|Absolute change from baseline in serum phosphorus to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||mg/dL||Standard Error|Mean
1267570|NCT00379899|Secondary|Percent Change in Calcium|Percent change from baseline in corrected serum calcium to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Percentage||Standard Error|Mean
1267571|NCT00379899|Secondary|Absolute Change in Calcium|Absolute change from baseline in serum calcium to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||mg/dL||Standard Error|Mean
1267572|NCT00379899|Secondary|Percent Change in PTH|Percent change from baseline in intact Parathyroid Hormone (iPTH)|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Percentage||Standard Error|Mean
1267573|NCT00379899|Secondary|Change From Baseline of the Progression of AVC.|Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Units on a scale||Standard Error|Mean
1267574|NCT00379899|Secondary|Change From Baseline in AC Score|Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Units on a scale||Standard Error|Mean
1267575|NCT00379899|Secondary|Absolute Change in PTH|Absolute change from baseline in intact Parathyroid Hormone (iPTH)|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||pg/mL||Standard Error|Mean
1267576|NCT00379899|Secondary|Number of Participants Achieving > 15% Progression of CAC.|Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52|52 weeks|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Participants|||Number
1267577|NCT00379899|Primary|Percent Change From Baseline in CAC Score|Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Units on a scale||Standard Error|Mean
1267578|NCT00379834|Primary|Diurnal Intraocular Pressure Control|Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)|12 months|Selected by level funding available|||millimeters of mercury||Standard Deviation|Mean
1267590|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267579|NCT00379821|Secondary|Pharmacokinetics of Chloroquine Represented by Maximum Concentration (Cmax)|1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Cmax in nanograms per milliliter (ng/mL).|Day 0 - Day 28|All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.|||ng/mL chloroquine||95% Confidence Interval|Median
1267580|NCT00379821|Secondary|Pharmacokinetics of Chloroquine Represented by Time of Maximal Concentration (Tmax) and Chloroquine Half-life|1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Tmax and half-life.|Day 0 - Day 28|All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.|||Hours||95% Confidence Interval|Median
1267581|NCT00379821|Secondary|Nearest Neighbor Index as a Measure of Spatial Pattern of the Distribution of Malaria Cases in Ndirande|The Global Positioning System (GPS) was used to establish the coordinates of participants' homes. The distribution of these coordinates was analyzed for evidence of clustering, or occurring closer together than would be expected on the basis of chance. Nearest Neighbor Index is a ratio of the observed mean distance over the expected mean distance. If the index is less than 1, the pattern exhibits clustering. If the index is greater than 1, the trend is toward dispersion.|1 year|The analysis included all participants for whom the GPS coordinates of the home were established.|||Index|||Number
1267582|NCT00379821|Secondary|Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.|The cumulative hazard of having a malaria attack within one year for those participants who travelled and slept in rural areas (outside the city) versus those who did not was calculated and is presented as a life table to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point. Participants are right-censored at the time of first malaria episode. Participants who did not develop malaria during follow-up or were lost to follow-up were censored at the time of their last visit.|Days 0 - 420||||participants|||Number
1267583|NCT00379821|Secondary|Number of Participants With New and Recrudescent Infections After Subsequent New Episodes|Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, participants who subsequently suffered new malaria episodes were monitored for the additional occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.|Day 28 to 1 year|The analysis population is limited to participants who had new episodes of malaria during the follow-up period after treatment.|||participants|||Number
1267584|NCT00379821|Secondary|Number of Participants With New and Recrudescent Malaria Infections After Initial Treatment|Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, subjects were monitored for the occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.|28 days to 1 year|All subjects completing the initial treatment were included in the analysis population.|||participants|||Number
1267585|NCT00379821|Secondary|Number of Participants Infected With Parasites With the Mutation Pfcrt 76T at Recrudescent Episodes of Malaria|Participants were enrolled in the study at the time of the initial episode of malaria. If the participant presented with a subsequent episode of malaria at any time during the one year of follow-up, the presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.|Recrudescent episodes of malaria within one year of enrollment|The analysis population is limited to participants who presented with subsequent episodes of malaria from whom samples were successfully collected and DNA successfully amplified.|||participants|||Number
1267586|NCT00379821|Secondary|Number of Participants Infected With Parasites With the Mutation Pfcrt 76T on Day 0 of the Initial Episode of Malaria|The presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.|Day 0 of initial episode of malaria|All participants from whom samples were successfully collected and DNA successfully amplified were included.|||participants|||Number
1267587|NCT00379821|Secondary|Number of Participants in Each Treatment Arm Who Change From “Normal” to “Abnormal” on Any Questions of the Neurological Examination|"A basic age-appropriate neurological examination was conducted on Day 28 of each malaria illness episode and also at Days 112 and 224, and at 1 year. Subjects were were counted as a change from 'normal' to 'abnormal'  if they had the 'normal' (or not-applicable) response for the initial day 28 exam and an 'abnormal' response at their last exam. If a subject did not have an exam at 1 year then the last available exam that was not associated with an illness episode (either Day 112 or 224) was used."|1 Year|Subjects who did not have an initial exam, or who did not have a subsequent exam at a routine visit are excluded.|||Participants|||Number
1267588|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267591|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267592|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267593|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267594|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267595|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267596|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267597|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
1267598|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267599|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267600|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267601|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267602|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267603|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267604|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267605|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267622|NCT00379808|Primary|High-sensitivity C-reactive Protein|measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)|1 month|based on patients who completed the entire study|||mg/dl||Inter-Quartile Range|Median
1267606|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267607|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
1267608|NCT00379821|Secondary|Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants Greater Than 3 Years to 5 Years of Age.|Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.|1 year|The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.|||Grams/Deciliter||95% Confidence Interval|Mean
1267609|NCT00379821|Secondary|Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger.|Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.|1 year|The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.|||Grams/Deciliter||95% Confidence Interval|Mean
1267610|NCT00379821|Secondary|Number of Cases of Severe Malaria in Each Treatment Arm|A case of severe malaria included one or more of the following: Hemoglobin ≤5 g/dL; prostration; respiratory distress; bleeding; recent seizures, coma or obtundation (Blantyre coma score < 5); inability to drink, or persistent vomiting. All cases were then adjudicated by a panel of investigators prior to analysis.|1 Year|The safety cohort includes all participants.|||Cases of severe malaria|||Number
1267611|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of fourth subsequent malaria episode (Episode 4)|This analysis was per protocol, which includes participants who had 4 subsequent malaria episodes, but excludes participants if the fourth episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the fourth episode.|||Participants|||Number
1267612|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of third subsequent malaria episode (Episode 3)|This analysis was per protocol, which includes participants who had at least 3 subsequent malaria episodes, but excludes participants if the third episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the third episode.|||Participants|||Number
1267613|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of second subsequent malaria episode (Episode 2)|This analysis was per protocol, which which includes participants who had at least 2 subsequent malaria episodes, but excludes participants if the second episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the second episode.|||Participants|||Number
1267614|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of first subsequent malaria episode (Episode 1)|This analysis was per protocol, which includes participants who had at least 1 subsequent malaria episode, but excludes participants who did if that episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the first subsequent episode.|||Participants|||Number
1267615|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of initial malaria episode (Episode 0)|This analysis was per protocol, which excludes participants who did not have p. falciparum or who did not receive all 3 doses of treatment.|||Participants|||Number
1267616|NCT00379821|Primary|Number of Clinical Malaria Episodes Per Year of Follow-up|Clinical malaria episode was defined as at least one symptom of malaria and a positive malaria smear. The number of clinical malaria episodes (not including the initial malaria episode) reported by participants during follow up is presented as the number per Person Years at Risk (PYAR).|1 year|The intention to treat (ITT) population was used for the primary outcome.|||Episodes per PYAR|||Number
1267617|NCT00379808|Other Pre-specified|Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)|biomarker determined by enzyme-linked immunosorbant assay.|1 month|those completing the entire study|||pg/ml||Inter-Quartile Range|Median
1267618|NCT00379808|Other Pre-specified|Interleukin 1 Receptor Antagonist (IL1ra)|IL1ra was determined by enzyme-linked immunosorbant assay (ELISA)|1 month|all participants who completed the entire study|||pg/ml||Inter-Quartile Range|Median
1267619|NCT00379808|Other Pre-specified|Monocyte Chemotactic Protein-1 (MCP-1)|biomarker was measured by enzyme-linked immunosorbant assay (ELISA)|1 month|those who completed the entire study|||pg/ml||Inter-Quartile Range|Median
1267620|NCT00379808|Other Pre-specified|Triglycerides|measured by a clinical laboratory; Quest Laboratories|1 month|those completing the entire study|||mg/dl||Inter-Quartile Range|Median
1267621|NCT00379808|Secondary|High Density Lipoprotein (HDL)-Cholesterol|Lipid levels were determined at a clinical laboratory (Quest Diagnostics)|1 month|those completing entire study|||mg/dl||Inter-Quartile Range|Median
1267623|NCT00379795|Primary|Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24|Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.|Month 12 and 24|"Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by n"|||participants|||Number
1267624|NCT00379795|Secondary|Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters|Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.|Extension study baseline, Months 12 and 24|"Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."|||letters||Standard Deviation|Mean
1267625|NCT00379795|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters|Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.|Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24|"Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."|||letters||Standard Deviation|Mean
1267626|NCT00379795|Primary|Number of Participants With Non-ocular Adverse Events|"Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.~Additional information about adverse events can be found in the adverse events section."|36 months|Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.|||participants|||Number
1267627|NCT00379795|Primary|Number of Participants With Ocular Adverse Events|"Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded."|36 months|All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.|||participants|||Number
1267628|NCT00379769|Secondary|Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267629|NCT00379769|Secondary|Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||bone fracture events|||Number
1267630|NCT00379769|Secondary|Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||bone fracture events|||Number
1267631|NCT00379769|Secondary|Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267632|NCT00379769|Secondary|Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267633|NCT00379769|Secondary|Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267634|NCT00379769|Secondary|Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267635|NCT00379769|Secondary|Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267636|NCT00379769|Secondary|Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267648|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions|The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267637|NCT00379769|Secondary|Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267638|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up|The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267639|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined|The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267640|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event – Overall and by Gender: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267641|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event – Overall and by Gender: Main Study and Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267642|NCT00379769|Secondary|Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267643|NCT00379769|Secondary|Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267644|NCT00379769|Secondary|Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up|The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267645|NCT00379769|Secondary|Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined|The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267646|NCT00379769|Secondary|Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267647|NCT00379769|Secondary|Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
1267805|NCT00378014|Secondary|Incidence of Efficacy Failure|Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).|Month 11|ITT|||Percentage of participants|||Number
1267649|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions|Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267650|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions|The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267651|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions|The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267652|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions|The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267653|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions|"The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as unknown deaths, but were counted as CV deaths for the analysis of this endpoint."|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267654|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions|Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267655|NCT00379769|Primary|Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions|IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267656|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause|All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267677|NCT00379769|Secondary|Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum|Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||partcipants|||Number
1267657|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
1267658|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
1267659|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
1267660|NCT00379769|Secondary|Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||mmHg (millimeters of mercury)||Standard Error|Mean
1267661|NCT00379769|Secondary|Model Adjusted Change From Baseline in Waist Circumference at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||cm (centimeters)||Standard Error|Mean
1267662|NCT00379769|Secondary|Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||U/L (Units/Liter)||95% Confidence Interval|Mean
1267663|NCT00379769|Secondary|Model Adjusted Change From Baseline in Body Weight at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||kilograms||Standard Error|Mean
1267664|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
1267665|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
1267678|NCT00379769|Secondary|Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths|The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||Number of events|||Number
1267806|NCT00378014|Primary|Calculated Glomerular Filtration Rate (cGFR)|This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.|Month 11|ITT|||mL/min||Standard Deviation|Mean
1267666|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
1267667|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
1267668|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
1267669|NCT00379769|Secondary|Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60|Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267670|NCT00379769|Secondary|Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||picamoles/liter (pmol/L)||Standard Error|Mean
1267671|NCT00379769|Secondary|Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||mmol/L (millimoles/Liter)||Standard Error|Mean
1267672|NCT00379769|Secondary|Model Adjusted Change From Baseline in HbA1c at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.|Baseline and Month 60 of randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||Percent||Standard Error|Mean
1267673|NCT00379769|Secondary|The Number of Participants Starting Insulin at Any Time During the Study|The number of participants starting insulin at any time during the study was recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267674|NCT00379769|Secondary|Number of Participants With Addition of Third Oral Agent/Switch to Insulin|The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267675|NCT00379769|Secondary|Number of Participants With Glycaemic Failure Events|Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.|Baseline through to end of randomised dual therapy|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267676|NCT00379769|Secondary|Number of Participants With CV/Microvascular Events|The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267679|NCT00379769|Secondary|Number of Participants With Cardiovascular Events and All-cause Deaths|Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267680|NCT00379769|Primary|Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events|The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
1267681|NCT00379639|Primary|Best Overall Response|"Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging:~Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).|The Efficacy Evaluable (EE) population consisted of all patients who completed at least 2 consecutive cycles of treatment, had at least 1 post-Baseline efficacy assessment performed, and did not have any major protocol violations.|||participants|||Number
1267682|NCT00379639|Primary|Number of Participants With Adverse Events (AEs)|"AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.~A serious AE is associated with events that pose a threat to a patient’s life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes."|From the date of first dose to 30 days after last dose (up to 236 days).|Safety population.|||participants|||Number
1267683|NCT00379639|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|"Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment:~Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1."|28 days|Safety population - all participants who received at least one dose of study drug.|||participants|||Number
1267684|NCT00379587|Secondary|Incidence of Adverse Hematological Events|White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.|by 18 months after peripheral blood stem (PBSC) infusion||||participants|||Number
1267685|NCT00379587|Secondary|Incidence of Relapse or Progression of Disease|Percentage of participants with relapsed disease by year 4 post transplant.|by 4 years after peripheral blood stem cell (PBSC) infusion||||percentage of participants|||Number
1267686|NCT00379587|Secondary|Incidence of Grade 3 or Higher Infectious Complications||by 1 and 2 years after peripheral blood stem cell (PBSC) infusion||||percentage of participants|||Number
1267687|NCT00379587|Primary|Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years||by 1 and 2 years after peripheral blood stem cell (PBSC) infusion||||percentage of participants|||Number
1267688|NCT00379574|Secondary|Number of Patients Who Experienced Adverse Events||6 months||||participants|||Number
1267689|NCT00379574|Primary|Number of Patients Who Achieved Complete Response|All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.|14 weeks||||participants|||Number
1267690|NCT00379353|Secondary|Change in Serum Cytokines and Receptors|Cytokines Levels of IL-1β and its receptor IL RA, IL-6 its receptor IL-6R, and TNF-α and its receptors (i.e. tumor necrosis factor receptor (TNFR)) of TNFR1, TNFR2, IL-10, IL-8(serum) measured at baseline, Days 15 and 29. Multiplex bead Immunoassay used to measure serum/plasma levels of IL-1, IL-6, TNF-α, IL-10, IL-8 and their receptors where assay sensitivity for the cytokines was 3-6 pg/mL. Serum IL-10, IL-1β, IL-1RA, IL-6R, sTNF-RI, sTNF-R2 were also analyzed using an enzyme-linked immunosorbent assay device. Lowering cytokine levels can decrease fatigue, increase appetite and decrease anxiety and depression.|Baseline to Day 15||||pg/mL||Inter-Quartile Range|Median
1267691|NCT00379353|Secondary|Change in Body Composition as Measured by Body Mass Index (BMI)|BMI, commonly used to measure overweight and obesity, is a measure of body fat based on a person's weight and height.|Baseline to Day 29||||kg/m^2||Full Range|Median
1267692|NCT00379353|Primary|Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS)|ESAS assessment of appetite (symptom) where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity. Evaluated at baseline [± 3 days], 2 weeks[± 3 days] and 4 weeks [± 3 days]|Baseline to Day 29||||units on a scale||Full Range|Median
1267693|NCT00379353|Secondary|Pittsburgh Sleep Quality Index (PSQI)|PSQI measures the quality and patterns of sleep. It differentiates poor from good sleep by measuring subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A participant indicates how frequently each item was experienced on a scale from 0 to 3. The 7 component scores are then summed to obtain a global sleep score that can range from 0 to 21. A score of >/= 5 indicates poor sleepers.|Baseline to Day 29||||units on a scale||Full Range|Median
1267694|NCT00379353|Secondary|Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression)|The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0–3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0–21). The higher the score, the more likely the patient is showing signs of depression and as a result may benefit from a counseling/supportive session.|Baseline to Day 29||||units on a scale||Full Range|Median
1267695|NCT00379353|Secondary|Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety)|The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0–3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0–21). The higher the score The higher the score, the more likely the patient is showing signs of anxiety and as a result may benefit from a counseling/supportive session.|Baseline to Day 29||||units on a scale||Full Range|Median
1267696|NCT00379353|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)|The FACIT-F consists of 27 general quality of life questions divided into 4 domains (physical, social, emotional and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4 (0= not at all, 4= very much) where the 13-item fatigue subscore totals are combined for a total of 0 to 52, with the higher number representing greater fatigue.|Baseline to Day 29||||units on a scale||Full Range|Median
1267697|NCT00379353|Secondary|Functional Assessment of Anorexia/Cachexia Therapy (FAACT)|12-item symptom-specific subscale of the FACT-G designed to measure participants' additional concerns about their anorexia/cachexia during the previous 7 days. Participant rates concerns from 0 to 4 (0= not at all, 4= very much), combined are the 12 items subscales for a total of 0 to 48 where the higher number would represent greater concern.|Baseline to Day 29||||units on a scale||Full Range|Median
1267698|NCT00379340|Secondary|Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|At 4 years|Analysis population is eligible stage (stg) IV patients (pts) with lung mets only. On Participant Flow table, these pts include 120 RCR, 135 SIR, 21 stg IV with LOH (of 52 when including stg III), and 23 stg IV with lung mets (off therapy before week 6). A total of 299 stg IV pts, exceeding the total number of participant (297) analyzed for OM 4.|||Probability||95% Confidence Interval|Number
1267699|NCT00379340|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study|At 4 years|All eligible patients were included in this analysis.|||Probability of EFS at 4 years||95% Confidence Interval|Number
1267700|NCT00379340|Primary|Event Free Survival (EFS) Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|At 4 years|Analysis includes only eligible patients.|||Probability of EFS at 4 years||95% Confidence Interval|Number
1267701|NCT00379340|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|4 years||||Probability||95% Confidence Interval|Number
1267702|NCT00379288|Primary|The Number of All Randomized Subjects Reporting Adverse Events (AEs).|AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.|1 year||||participants|||Number
1267703|NCT00379236|Secondary|Change From Baseline (Extension Study Week 26) in Use of Rescue Medication at Week 52.|The change in the number of tablets of study-specific acetaminophen taken per week as a rescue medication from knee pain.|Extension baseline (week 26 pre-dose), week 52|Intent to treat population|||tablets per week||Standard Deviation|Mean
1267704|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 52|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer:YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 52 (Extension Study)|Intent to treat population.|||participants|||Number
1267705|NCT00379236|Secondary|Mean Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Extension Study|The mean difference in participant pain as measured by participants during a walk of 50 feet in length between the baseline (week 26 pre-dose) and week 52 scores. Scores are measured on a visual analog scale of 100 millimeters, with a score of 0 millimeters meaning there was no pain observed; a score of 100 millimeters meaning extreme pain was observed.|Extension baseline (week 26), week 52|Intent to treat population. No imputation for missing values.|||units on a scale||Standard Deviation|Mean
1267706|NCT00379236|Secondary|Observed Pain Scores on the 50-foot Walk Test During the Extension Study|Participant pain during a walk of 50 feet in length was evaluated by participants on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Baseline (week 26), week 52|Intent to treat population. No imputation for missing values.|||units on a scale||Standard Deviation|Mean
1267707|NCT00379236|Secondary|Number of Participants With 20 Millimeter or Greater Improvement in Pain Scores on the 50-foot Walk Test|Yes represents the number of participants whose pain during a walk of 50 feet in length was improved at week 26 over baseline by at least 20 millimeters. Pain was evaluated on a 100 millimeter visual analog scale by participants. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Weeks 0 and 26|Intent to treat population|||participants|||Number
1267708|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. The questionnaire is completed by participants. This table summarizes the change from baseline in participants' physical health.|Weeks 0, 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
1267709|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) General Health(GH) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' general health scores. The questionnaire is completed by participants.|weeks 0 and 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
1267763|NCT00378508|Secondary|Baseline Hemoglobin A1c||At baseline (before treatment)||||percentage of hemoglobin A1c||95% Confidence Interval|Least Squares Mean
1267710|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Bodily Pain(BP) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' bodily pain scores. The questionnaire is completed by participants.|weeks 0 and 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
1267711|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Function (PF) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' physical function. The questionnaire is completed by participants.|Weeks 0, 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
1267712|NCT00379236|Secondary|Change From Baseline in the Number of Tablets of Rescue Medication Used at Week 26.|The change in the number of tablets of 500 milligram acetaminophen used in a week as rescue medication is compared at weeks 0 and weeks 26.|Weeks 0 and 26|Intent to treat population|||tablets per week||Standard Deviation|Mean
1267713|NCT00379236|Secondary|Change From Baseline in Patient Global Assessment of Knee Pain at Week 26|Participant assessment of knee pain evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain.|Weeks 0 and 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
1267714|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Redness at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Redness of the knee was subjectively rated as Yes (knee was red) and No (knee was not red).|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.|||participants|||Number
1267715|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Local Warmth at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Local warmth of the target knee was recorded as Yes (warmth present) or No (knee was not warmer than expected).|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.|||participants|||Number
1267716|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Tenderness at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Tenderness of the knee was subjectively rated by participants as none, mild, moderate or severe.|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.|||participants|||Number
1267717|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Range of Motion Findings at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Range of motion indicates the flexibility of the knee, and is measured by the number of degrees between when the knee is hyper-extended and when the knee is flexed.|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.|||participants|||Number
1267718|NCT00379236|Primary|Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the baseline (week 0) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters meaning no pain was observed; a score of 100 millimeters meaning extreme pain was observed.|Weeks 0 and 26|Intent to treat population.|||percent change from baseline value||Standard Deviation|Mean
1267719|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 26|Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|week 26|Intent to treat population|||participants|||Number
1267720|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 12|Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 12|Intent to treat population|||participants|||Number
1267721|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 26|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 26|Intent to treat population|||participants|||Number
1267722|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 12|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 12|Intent to treat population|||participants|||Number
1267723|NCT00379236|Secondary|Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study for a Subpopulation of Participants With More Severe Knee Pain|Percent difference in participant pain during a walk of 50 feet in length between the mean screening (week -1) and baseline(week 0) scores, and week 26 scores. Scores are recorded by participants and measured on a visual analog scale of 100 millimeters, with 0 millimeters meaning there was no pain observed; 100 millimeters meaning extreme pain was observed.|weeks -1, 0, and 26|Intent to treat population. A subpopulation of patients with more severe knee pain, as measured by having a greater than or equal to 41 millimeter screening score on the 50-foot walk test.|||percentage change from baseline score||Standard Deviation|Mean
1267724|NCT00379236|Secondary|Percent Change From Screening in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the screening (week -1) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|weeks -1 and 26|Intent to treat population|||percent change from screening value||Standard Deviation|Mean
1267725|NCT00379236|Primary|Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Weeks 0, 26|Intent to treat (ITT) population.|||units on a scale||Standard Deviation|Mean
1267726|NCT00379210|Primary|Reaction Times on the Sustained Attention to Response Task.|Single digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target.|9 weeks||||milliseconds||Standard Deviation|Mean
1267727|NCT00379197|Secondary|Median Time to Event|First time when maximum SUV is higher than that at baseline within 1 year of study entry.|From Baseline to 1 Year|One of the 8 participants did not have an increase in SUV above baseline at 8 weeks, but no further PET scans were performed after 8 weeks. The reported median value is for the remaining 7 participants.|||weeks||Full Range|Median
1267728|NCT00379197|Primary|Disease Response|A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.|Week 4||||participants|||Number
1267729|NCT00379145|Primary|Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||participants|||Number
1267730|NCT00379145|Primary|Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.|Eligible and treated patients|||participants|||Number
1267731|NCT00379080|Secondary|Protein Expression Patterns Post Treatment - Loss or Gain|"serial blood samples over multiple time points (prior to treatment, 2 days post treatment, 8 days post treatment, 10 days post treatment and 28 days post treatment.~statistical analyses presented for the comparisons that yielded a p-value <=0.05"|baseline - cycle 2 (28 days)|peripheral blood was obtained from 20 patients enrolled in the phase 2 portion of the study.|||hazard ratio||95% Confidence Interval|Number
1267732|NCT00379080|Secondary|Proportion of Patients With Serious or Life Threatening Toxicities|Grade 3 or 4 toxicities related to treatment as determined by the CTCAE|2 year period||||percentage of participants|||Number
1267733|NCT00379080|Secondary|Overall Failure Rate (Phase II)|The overall failure rate is expressed as hazard of failure per person-year of follow-up.|up to 4 years||||failure per person-year||95% Confidence Interval|Number
1267734|NCT00379080|Secondary|Six-month Progression-free Survival Rate (Phase II)|"The probability of 6-momth progression-free survival will be estimated using binomial distribution.~Progression defined as: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion."|At 6 months|The probability of 6-momth progression-free survival will be estimated using binomial distribution.|||percent probability||95% Confidence Interval|Number
1267735|NCT00379080|Secondary|Overall Survival (Phase II)|Median time of survival along with 95% confidence interval will be estimated using Kaplan-Meier method. An overall failure rate will be estimated with 95% CI.|Up to 4 years|Median time of survival along with 95% confidence interval will be estimated using Kaplan-Meier method. An overall failure rate will be estimated with 95% CI. The overall failure rate is expressed as hazard of failure per person-year of follow-up.|||months||95% Confidence Interval|Median
1267736|NCT00379080|Primary|Pharmacokinetics; Steady-state Trough Concentration for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||ng/mL||Standard Deviation|Median
1267764|NCT00378508|Secondary|Baseline Insulin Use||At baseline (before treatment)|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)|||U/kg/d||95% Confidence Interval|Least Squares Mean
1267737|NCT00379080|Primary|Pharmacokinetics; Apparent Oral Total Body Volume of Distribution for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||L||Standard Deviation|Median
1267738|NCT00379080|Primary|Pharmacokinetics; Apparent Oral Clearance for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post surgery|||L/h||Standard Deviation|Median
1267739|NCT00379080|Primary|Pharmacokinetics (Area Under the Plasma Concentration Time Profile From Zero to Infinity (AUC)) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||ng*h/mL||Standard Deviation|Median
1267740|NCT00379080|Primary|Pharmacokinetics (Apparent Terminal Phase Half-life) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||h||Standard Deviation|Median
1267741|NCT00379080|Primary|Pharmacokinetics (Max Concentration of Plasma) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||ng/mL||Standard Deviation|Median
1267742|NCT00379080|Primary|Tumor Response (Complete Response and Partial Response) Rate (Phase II)|"pts receive a scan baseline and prior to every odd cycle. All responses are centrally reviewed Complete response Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks Partial response Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease Clinical status and MRI does not qualify for complete response, partial response or progression"|Up to 4 years|In the first stage, 31 patients would be enrolled and the trial would be terminated if 3 or fewer patients demonstrated objective responses (partial response or complete response)|||participants with objective response|||Number
1267743|NCT00379080|Primary|Number of Dose Limiting Toxicities Per Dose Level|"cohorts of 3-6 pts will recieve oral tandutinib starting at 500mg BID with a dose escalation in each cohort. Each treatment cycle is 28 days. Evaluation period for MTD is 1st cycle - 28 days.~dose limiting toxicity defined as: grades 3-4 severity (except vomiting and diarrhea without sufficient prophylaxis delay of treatment > 14 days. ANC less/equal 500m/mm3; Plts less/equal 25,000/mm3; febrile neutropenia or delay of treatment > 14 days"|28 days|all GBM, All prior treatment with RT. assessment was for 28 days, cycle 1. 3 dose levels 500, 600 and 700mg|||participants|||Number
1267744|NCT00379080|Primary|To Determine the Tumor/Plasma Ratio of in Subjects With Recurrent GBM Undergoing Resections (Phase 0)|participants are administered tandutinib (500mg BID) for 7 days prior to surgery and then undergo resection for recurrent glioblastoma. Tissue samples will be collected for correlative studies - determine tumor/plasma ratio.|7 days prior to surgery including surgery|a tandutinib tumor:plasma ratio of >/=0.33 was the objective in a minimum of 3/6 subjects in order to proceed with Phase 1/2 study. 6 samples received, but 2 samples were found to be thawed at receipt and not used in analysis|||ratio||Standard Deviation|Mean
1267745|NCT00379080|Primary|Maximum Tolerated Dose of Tandutinib Defined by Dose Limiting Toxicities (Phase 1)||cycle 1 - 28 days|19 patients enrolled in dose escalation but 4 were removed for reasons other than drug related toxicity|||mg BID|||Number
1267746|NCT00378898|Secondary|Subjects Reporting Chest Pain|Edmonton Symptom Assessment is used to measure the presence and change in symptoms.|48 hours|2 subjects had to have the BRAVO removed before 48 hours due to reported discomfort in the BRAVO placement group so chest pain scores were obtained for 9 of the 11 subjects.|||Participants|||Count of Participants
1267747|NCT00378898|Primary|Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort||48 hours||||participants|||Number
1267748|NCT00378703|Secondary|Objective Response Rate|Response was assessed using Solid Tumor Response Criteria (RECIST). Patients with complete responses or partial responses are considered having an objective response.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients|||Proportion of patients||95% Confidence Interval|Number
1267749|NCT00378703|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death. Patients alive at last contact were censored on the date of last contact.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients|||Months||90% Confidence Interval|Median
1267750|NCT00378703|Secondary|Proportion of Patients With Stable Disease at 6 Months|Patients whose date of progression was after 6 months or who were disease-free at last follow-up beyond 6 months were considered to be stable at 6 months and all other patients were not.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients|||Proportion of patients||95% Confidence Interval|Number
1267751|NCT00378703|Primary|Progression-free Survival (PFS)|Progression-free survival is defined as time from randomization to clinical evidence of disease progression or death from any cause without progression. Patients alive without progression were censored at the date of last disease assessment.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients|||Months||90% Confidence Interval|Median
1267752|NCT00378599|Primary|A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment|Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.|24 weeks after completion of up to 48 weeks of therapy|Intent to Treat (ITT) Data Set: All enrolled subjects who received at least one dose of any study medication (PEG-Intron or Rebetol (RBV)). Analysis of all primary and secondary efficacy endpoints and safety variables was based on the ITT population.|||Participants|||Number
1267753|NCT00378573|Secondary|Overall Survival|Survival is defined as the time from the date of registration to the study to the date of death.|2 years post-registration|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.|||Month|||Number
1267754|NCT00378573|Secondary|Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)|"Complete response is defined as disappearance of all target and nontarget lesions identified and reported at baseline (at or within 4 weeks before the beginning of treatment) by image-based evaluations such as computerized tomography (CT) or magnetic resonance imaging (MRI).~Partial response is defined as persistence of one or more nontarget lesions and at least 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters."|1 year from start of treatment|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.|||Participants|||Number
1267755|NCT00378573|Primary|Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy||1 year post-registration|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.|||Days||95% Confidence Interval|Median
1267756|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
1267757|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
1267758|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
1267759|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.~The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
1267760|NCT00378560|Primary|Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype|Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.|Over 30 months|Includes participants who were not general protocol violators, received all 3 vaccinations, and were seronegative at Day 1 and PCR negative through Month 7 for the relevant HPV type|||Incidence per 100 person-years|||Number
1267761|NCT00378534|Secondary|Standard Transplant Outcome Variables Such as Non-hematologic Toxicity, Incidence and Severity of Acute and Chronic GVHD and Relapse of Disease.||3 years maximum|||||||
1267762|NCT00378534|Primary|Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse mortality at day +200.|Day 200||||participants|||Number
1267765|NCT00378508|Primary|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline|"C-peptide secretory response was calculated as ln[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1]~For presentation, the C-peptide data were converted to the AUC as pmol/ml. This baseline data was used to adjust for the C-peptide AUC primary endpoint measure at 12 months."|At Baseline (before treatment)|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)|||pmol/ml||95% Confidence Interval|Least Squares Mean
1267766|NCT00378508|Secondary|Average Insulin Use Over 12 Months||After 12 months post-treatment|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)|||U/kg/d||95% Confidence Interval|Least Squares Mean
1267767|NCT00378508|Secondary|Hemoglobin A1c||At 12 months post-treatment||||percentage of hemogloblin A1c||95% Confidence Interval|Least Squares Mean
1267768|NCT00378508|Primary|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months|"C-peptide secretory response was calculated as ln[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1]~For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline."|At month 12 post-treatment|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)|||pmol/ml||95% Confidence Interval|Least Squares Mean
1267769|NCT00378378|Secondary|Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine|The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).|Baseline to Endpoint||||mcg/hour||Standard Deviation|Least Squares Mean
1267770|NCT00378378|Primary|Change From Baseline 24-hour Urinary Free Cortisol Level|The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject’s 24-hour urinary free cortisol level.|Baseline to Endpoint|Not all participants that were randomized had both a baseline and an endpoint urine sample. Only participants with both were included in the participants analyzed.|||mcg/hour||Standard Deviation|Least Squares Mean
1267771|NCT00378352|Secondary|Number of Participants With Clinical Events||from randomization to second CMR||||Participants|||Count of Participants
1267772|NCT00378352|Secondary|Reticulocyte Counts||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days||||percentage of red blood cells||Standard Deviation|Mean
1267773|NCT00378352|Secondary|Hemoglobin Levels||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days||||g/dL||Standard Deviation|Mean
1267774|NCT00378352|Secondary|Vital Signs||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days||||mmHg||Standard Deviation|Mean
1267775|NCT00378352|Secondary|LV Mass Indexed to BSA||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination|||g/m^2||Standard Deviation|Mean
1267776|NCT00378352|Secondary|LV Volume Indexed to BSA||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination|||ml/m^2||Standard Deviation|Mean
1267777|NCT00378352|Secondary|LV Ejection Fraction||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination|||percent||Standard Deviation|Mean
1267778|NCT00378352|Secondary|Infarct Size in the Territory of the Infarct Related Artery|Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.|12 ± 2 weeks after study medication|Analysis only performed on subjects who completed the CMR examination|||percentage of LV mass||Standard Deviation|Mean
1267779|NCT00378352|Primary|Infarct Size in the Territory of the Infarct Related Artery|Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.|performed 2 to 6 days after study medication administration (first CMR)|Analysis only performed on subjects who completed the CMR examination|||percentage of LV mass||Standard Deviation|Mean
1267780|NCT00378326|Primary|Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus|Survival in patients with paraneoplastic disease who are treated with Tacrolimus, from time of tacrolimus treatment|through study completion, median 3 years of follow up||||months||95% Confidence Interval|Median
1267781|NCT00378326|Secondary|Cerebrospinal Fluid (CSF) Pleocytosis||White blood cell count in CSF was measured at two time points, pre- and post-treatment|"19 treatment events in 16 patients at which both pre- and post-treatment CSF samples available.~The data are reported below, separately for pre-treatment samples and post-treatment samples."|||cells/mm^3|Participants|Full Range|Median
1267782|NCT00378209|Secondary|Overall Survival|defined as time from treatment initiation to death, or last known to be alive for those who had not died|assesed at a median follow-up of 44 months||||month||95% Confidence Interval|Median
1267783|NCT00378209|Secondary|Progression Free Survival|Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.|aassesed at a median follow-up of 44 months||||months||95% Confidence Interval|Median
1267784|NCT00378209|Secondary|Duration of Response|Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.|Assessed at a median follow-up of 44 months||||months||95% Confidence Interval|Median
1267785|NCT00378209|Secondary|Objective Response Rate|"Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG).~Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response)."|Assessed every cycle for up to 8 cycles and best response was reported||||percentage of treated patients||90% Confidence Interval|Number
1267803|NCT00378014|Secondary|Incidence of Renal Deterioration|Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement. The analysis of this outcome measure was omitted because of missing relevance.|Baseline, Month 11|||||||
1267786|NCT00378209|Primary|The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months|"Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG).~Progressive disease (PD) required one or more of the following:~>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) >25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.~Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).~Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause)."|6 months after therapy||||percentage of treated patients||90% Confidence Interval|Number
1267787|NCT00378105|Secondary|Estimated 18-month Overall Survival Rate|Overall survival was measured from treatment initiation to death, censored at the date patients were last known to be alive for those who had not died.|Survival rate at 18 months||||Percentage of participants||95% Confidence Interval|Number
1267788|NCT00378105|Secondary|Percentage of Patients Who Remained in Response for More Than 18 Months|Duration of response was measured from first response to progression or death, censored at the date patients were last known to be alive and disease free for patients who had not progressed or died.|Response rate at 18 months||||Percentage of participants||95% Confidence Interval|Number
1267789|NCT00378105|Secondary|Estimated 18-month Progression Free Survival (PFS) Rate|"PD from European Bone Marrow Transplant (EBMT) Response Criteria Required one or more:~>25% increased in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, or >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation), or >25% increased in plasma cells in a bone marrow aspirate or biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.~Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).~Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).~PFS was measured from treatment initiation to progression or death, censored at the date patients were last known to be alive and disease free"|PFS rate at 18 months|This numbers excluded 2 patients who went off study prior to start of therapy.|||Percentage of participants||95% Confidence Interval|Number
1267790|NCT00378105|Primary|Objective Response Rate of the Drug Combination in This Patient Populations.|Overall Response (OR) was defined as partial response (PR) or better. Response was assessed according to European Group for Blood and Marrow Transplant criteria, modified to include nCR and VGPR, from the International Uniform Response Criteria.|Full response assessment was conducted at the end of cycle 8 (average of168 days) and after cycle 4 (84 days) for patients proceeding to transplant.|The numbers excluded 2 patients who went off study prior to start of therapy|||percentage of participants||90% Confidence Interval|Number
1267791|NCT00378079|Secondary|Employment|number of days employed, past 30 days-self report, assessed one year post-prison release|one year||||number of days employed, past 30||Standard Deviation|Mean
1267792|NCT00378079|Primary|Criminal Activity|self reported days of criminal activity|one year post prison release||||number of days||Standard Deviation|Mean
1267793|NCT00378079|Primary|HIV-risk Behaviors||one year|||||||
1267794|NCT00378079|Primary|Cocaine Use|cocaine urine test results-percent of participants testing positive for cocaine|one year post prison release|Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due, excludes those assessed later or reincarcerated|||percent cocaine positive participants|||Number
1267795|NCT00378079|Primary|Heroin Use|opioid urine test results-percent of participants who were opioid-positive|results at one year post prison release|Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due-excludes those assessed later or reincarcerated|||% participants opioid positive|||Number
1267796|NCT00378079|Primary|Treatment Retention in the Community|days in community treatment|one year post prison release||||Days in community treatment||Standard Deviation|Mean
1267797|NCT00378014|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|Month 12 to Month 59 post-baseline|Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.|||Number of participants|||Number
1267798|NCT00378014|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|From randomization to Month 11|Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.|||Number of participants|||Number
1267799|NCT00378014|Secondary|Hepatitis C Virus (HCV) Replication in HCV-positive Patients|HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).|Baseline, Month 5|ITT|||Percentage of participants|||Number
1267800|NCT00378014|Secondary|Patient and Graft Survival|Patient survival was defined as the time from date of randomization to date of death from any cause. If a patient was not known to have died, patient survival was censored as the date of last contact. Graft survival was defined as the time from the date of randomization to the date of graft loss. If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively. Patient and graft survival were analyzed using the Kaplan Meier method.|Month 11|ITT|||Percentage of Participants|||Number
1267801|NCT00378014|Secondary|Incidence of Treated BPAR|The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).|Month 11|ITT|||Percentage of Participants|||Number
1267802|NCT00378014|Secondary|Renal Function (cGFR)|This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.|Month 5|ITT|||mL/min||Standard Deviation|Mean
1267836|NCT00377832|Secondary|Temperature Difference Before and After Treatment|Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade|90 minutes||||degrees Centigrade||Inter-Quartile Range|Median
1267809|NCT00377962|Secondary|Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup|Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were filling fraction (FF) and ejection fraction (EF). A positive change score indicates improved left ventricular function.|Baseline to end of study (Month 24)|Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||%||Standard Deviation|Mean
1267810|NCT00377962|Secondary|Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup|Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), interventricular septal wall thickness (IVSTd), and posterior wall thickness (PWTd). A positive change score indicates improved left ventricular function.|Baseline to end of study (Month 24)|Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||cm||Standard Deviation|Mean
1267811|NCT00377962|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup|Forced vital capacity (FVC) was measured by spirometry conducted according to internationally accepted standards. FVC is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. A positive change score indicates improved lung function.|Baseline to end of study (Month 24)|Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Liters||Standard Deviation|Mean
1267812|NCT00377962|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup|Forced expiratory volume in 1 second (FEV1) was measured by spirometry conducted according to internationally accepted standards. FEV1 is the volume delivered in the first second of a forced vital capacity (FVC) maneuver. A positive change score indicates improved lung function.|Baseline to end of study (Month 24)|Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Liters||Standard Deviation|Mean
1267813|NCT00377962|Secondary|Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)||Month 12 to end of study (Month 24)|The intent-to-treat (ITT) population consisted of all patients as randomized, who were given at least one dose of study drug and had at least one post-baseline assessment. (Extension study)|||Participants|||Number
1267814|NCT00377962|Secondary|Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)|Number of patients not alive and number of patients with loss of their graft.|Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Participants|||Number
1267815|NCT00377962|Secondary|Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)|Biopsy-proved acute rejection was defined as a treated acute rejection confirmed by biopsy, graded locally according to the International Society for Heart & Lung Transplantation (ISHLT) criteria. A treated acute rejection was defined as an acute rejection clinically suspected, whether biopsy-proven or not, which had been treated and confirmed by the investigator according to the response to therapy.|Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Participants|||Number
1267816|NCT00377962|Secondary|Change in Serum Creatinine From Baseline to End of Study (Month 24)|Renal function was assessed by determining serum creatinine using standard laboratory methods. A positive change score indicates improved renal function.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||μmol/L||Standard Deviation|Mean
1267817|NCT00377962|Secondary|Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)|Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||mL/min||Standard Deviation|Mean
1267818|NCT00377962|Primary|Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12|Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.|Baseline to Month 12|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||mL/min||Standard Deviation|Mean
1267819|NCT00377858|Secondary|Change From Baseline in Absolute Body Weight at 36 Week Endpoint|Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.|Baseline, 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||kilograms||Standard Error|Least Squares Mean
1267820|NCT00377858|Secondary|Number of Insulin Injections Per Day||Weeks 12, 24, 30, 36|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).|||insulin injections||Standard Error|Least Squares Mean
1267837|NCT00377832|Primary|Baseline Fetal Heart Rate (FHR) After Treatment||90 minutes||||beats per minute||Standard Deviation|Mean
1267838|NCT00377832|Primary|Maternal Body Temperature 90 Minutes After Randomization|Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded.|90 minutes||||degrees centigrade||Inter-Quartile Range|Median
1267821|NCT00377858|Secondary|Endpoint Insulin Dose; Total, Basal, and Prandial|Total daily insulin dose (Units of insulin per day [U/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.|36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||U/day||Standard Error|Least Squares Mean
1267822|NCT00377858|Secondary|Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial|Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.|36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||U/kg/day||Standard Error|Least Squares Mean
1267823|NCT00377858|Secondary|Number of Patients With at Least One Severe Hypoglycemia Episode|Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||participants|||Number
1267824|NCT00377858|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)|Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.|||hypoglycemic event per 30 days||Standard Deviation|Mean
1267825|NCT00377858|Secondary|Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia|Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.|||participants|||Number
1267826|NCT00377858|Secondary|Glycemic Variability|Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.|Baseline, 12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1267827|NCT00377858|Secondary|7-point Self-monitored Blood Glucose Profiles|Actual daily mean blood glucose levels at specified time points.|Baseline, 12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).|||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
1267828|NCT00377858|Secondary|Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint||12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).|||percentage of participants|||Number
1267829|NCT00377858|Secondary|Hemoglobin A1c (HbA1c) at Interval Visits|Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.|12, 24, and 36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.|||percent HbA1c||Standard Error|Least Squares Mean
1267830|NCT00377858|Primary|Hemoglobin A1c (HbA1c) at 36 Week Endpoint|Level of hemoglobin A1c at endpoint.|36 weeks|Number of participants in the per-protocol population. Last observation carried forward.|||percent HbA1c||Standard Error|Least Squares Mean
1267831|NCT00377832|Secondary|Rate of Neonatal Sepsis|the number of participants who developed neonatal sepsis|7 days||||participants|||Number
1267832|NCT00377832|Secondary|Rate of Diagnosis of Clinical Chorioamnionitis|Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.|Labor--up to 24 hours||||participants|||Number
1267833|NCT00377832|Secondary|Rate of Subsequent Development of Maternal Fever|Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.|Labor--up to 24 hours||||participants|||Number
1267839|NCT00377819|Secondary|Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)|Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.|Baseline, 3 months|Participants with non-missing baseline evaluation and non-missing post-baseline evaluation at month 3.|||Percent Change||Inter-Quartile Range|Median
1267840|NCT00377819|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.|Baseline, 12 months|Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.|||Percent Change||95% Confidence Interval|Least Squares Mean
1267841|NCT00377819|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.|Baseline, 12 months|Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.|||Percent Change||95% Confidence Interval|Least Squares Mean
1267842|NCT00377741|Secondary|Plasma Half-Life (T1/2) of Ganciclovir|Plasma half-life is the time measured for the plasma concentration to decrease by one half. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1. T1/2 was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||h||Standard Deviation|Mean
1267843|NCT00377741|Secondary|Apparent Elimination Rate (Kelim) of Ganciclovir|The apparent elimination rate is equal to the magnitude of the slope from the log-linear regression of plasma concentration versus time over the interval t to 24, where t is the first time-point used for this regression. Kelim was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||1/h||Standard Deviation|Mean
1267844|NCT00377741|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir|The Tmax is defined as time to reach maximum observed Ganciclovir concentration. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||h||Full Range|Median
1267845|NCT00377741|Primary|Maximum Observed Plasma Concentration (Cmax) of Ganciclovir|The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||μg/mL||Standard Deviation|Mean
1267846|NCT00377741|Primary|Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)|The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC [0-tau]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||h*mcg/mL||Standard Deviation|Mean
1267847|NCT00377676|Secondary|Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline.|The difference between Cycloset and placebo in the change in HbA1c from baseline to Week 24 was analyzed for subjects with a baseline HbA1c of ≥ 7.5% who were taking at least one oral hypoglycemia agent (OHA) at baseline. The primary analysis was based on subjects from the evaluable per protocol efficacy (EPPE) analysis set with a secondary analysis using subjects from the intent to treat efficacy (ITTE) analysis set for subjects completing 24 weeks of treatment. Change is reported as the absolute difference in % HbA1c.|Baseline to week 24|randomized subjects with a baseline HbA1c of >= 7.5 taking one or two oral diabetes agents (not insulin)|||percent||Standard Deviation|Least Squares Mean
1267848|NCT00377676|Secondary|Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea|"Change in HbA1c from baseline to week 24 in subjects failing treatment with metformin plus a sulfonylurea with failure defined as having a baseline HbA1c value of ≥ 7.5%. Change was measured at week 24 after randomization in subjects having no major protocol violations.~Change is reported as the absolute difference in % HbA1c."|Baseline to week 24|subjects with baseline HbA1c of >= 7.5 and taking both metformin/sulfonylurea but not insulin. Analysis was conducted for those completing 24 weeks of treatment and on the ITT using the LOCF for those not completing 24 weeks of treatment.|||percent||Standard Deviation|Least Squares Mean
1267849|NCT00377676|Secondary|Number of Subjects Experiencing Serious Cardiovascular Adverse Events|The secondary safety endpoint is number subjects with occurrences of first cardiovascular SAE (myocardial infarction, stroke, in-patient hospitalization for heart failure, angina or revascularization surgery).|Baseline to week 52.|intent to treat|||Subjects|||Number
1267850|NCT00377676|Primary|Subjects Experiencing Serious Adverse Events|Number of subjects reporting all-cause Serious Adverse Events (SAEs) for usual drug therapy plus Cycloset vs. that for usual drug therapy (UDT) plus placebo from baseline to week 52.|From baseline to week 52.||||participants|||Number
1267851|NCT00377637|Secondary|Maintenance Phase: Participants With Major Extra-renal Flare|A major extra-renal flare is defined as a British Isles Lupus Assessment Group (BILAG) Score category A in one extrarenal organ or three organs with concurrent category B scores. BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population.|||participants|||Number
1267852|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy|The primary efficacy parameter was the time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), defined as any of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to rescue treatment for each patient. The data presented are the percentage of participants who were rescue treatment free at each time interval as estimated by Kaplan-Meier.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.|||Percentage of participants|||Number
1267853|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval|A proteinuric flare is defined as a doubling of the urine protein:creatinine ratio, and proteinuria ≥1 g/24 h in patients with urine protein ≤0.5 g/24 h at the end of the induction phase, or proteinuria ≥2 g/24 h if urine protein was >0.5 g/24 h at the end of the induction phase. A nephritic flare is defined as a 25% increase in serum creatinine accompanied by 1 or more of the following: (a) simultaneous doubling of the proteinuria reaching a minimum of 2 g/24 h (b) new/increased hematuria or (c) the appearance of cellular casts. All flares were adjudicated by a clinical endpoints committee.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.|||Percentage of participants|||Number
1267854|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine|Sustained doubling of serum creatinine concentration is defined as the first serum creatinine value that is twice the mean of the lowest 2 values from screening to end of induction, as confirmed by a second serum creatinine value obtained at least 4 weeks after the initial doubling.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.|||participants|||Number
1267855|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD)|Time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), was defined as any 1 the following: death, ESRD, sustained doubling of serum creatinine, renal flare (proteinuric or nephritic), or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. ESRD is defined as progression to chronic hemodialysis or renal transplant.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.|||participants|||Number
1267856|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths|Treatment Failure was adjudicated by a clinical endpoints committee (CEC) and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis (LN).|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population.|||Deaths|||Number
1267857|NCT00377637|Secondary|Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores|The SF-36 is a 36 item quality of life questionnaire. The short-form version has eleven questions that permit the participant to rate how they feel that particular day. The SF-36 consists of eight scaled scores and two component scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score with the higher scores indicating better quality of life.|Baseline and 24 weeks|"This analysis population is intention to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."|||Scores on a scale||Standard Deviation|Mean
1267858|NCT00377637|Secondary|Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score|"BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. The BILAG individual system summaries were calculated by a program supplied by ADS-Limathon (Sheffield, UK).~The score at baseline was compared to the score at the 24 week endpoint for each treatment group, reported here for the renal system."|Baseline, 24 weeks|Analysis population was intent to treat. The endpoint was defined using the last observation carried forward approach. If no post-Baseline value was available, endpoint was considered missing.|||Percentage of participants|||Number
1267859|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in Serum Albumin||Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."|||g/L||Standard Deviation|Mean
1267860|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein|24-hour urine protein was measured at Baseline and Week 24.|Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."|||mg/day||Standard Deviation|Mean
1267861|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in Serum Creatinine||Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."|||µmol/L||Standard Deviation|Mean
1267862|NCT00377637|Secondary|Induction Phase: Number of Participants Achieving Complete Remission|Number of participants achieving complete remission as defined by return to normal serum creatinine, proteinuria ≤500 mg/24 hours and an inactive urinary sediment (absence of red blood cells, white blood cells or cellular or granular casts) after 24 weeks.|24 weeks|Analysis population was intent to treat.|||participants|||Number
1271442|NCT00349466|Secondary|Dry Eye Symptom Score|consists of 12 questions designed to assess the symptoms of ocular irritations, covering three areas: ocular symptoms, environmental triggers and visionrelated function|12 weeks|||||||
1267863|NCT00377637|Primary|Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval|Treatment Failure was adjudicated by a clinical endpoints committee and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to treatment failure for each patient. The data presented are the percentage of participants who were treatment-failure free at each time interval as estimated by Kaplan-Meier.|From the start of the Maintenance Phase to Month 36|Intent to treat analysis population which consisted of all subjects who were randomized to the maintenance phase of the study and had at least 1 maintenance efficacy assessment.|||Percentage of participants|||Number
1267864|NCT00377637|Primary|Induction Phase: Number of Patients Showing Treatment Response|Treatment response was adjudicated by a blinded clinical endpoints committee (CEC) and defined as: a) Decrease in proteinuria, defined as a decrease in the urine protein to creatinine ratio (UPCr) to <3 in subjects with baseline proteinuria ≥3 UPCr or a decrease in the UPCr by ≥50% in subjects with proteinuria <3 UPCr at Baseline, and b) Stabilization of serum creatinine or improvement. UPCr were derived from the 24 hour urine collection. Patients who did not show a treatment response at Week 24 or who withdrew earlier than Week 24 were considered non-responders.|24 weeks|Analysis population was intent to treat which comprised all subjects who were randomized into the study and had at least one post-baseline efficacy assessment.|||participants|||Number
1267865|NCT00377611|Primary|Serum HI Antibody Titers for Each Influenza Strain|Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1267866|NCT00377611|Primary|Serum HI Antibody Titers for Each Influenza Strain|Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).|At Day 0 (PRE)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1267867|NCT00377611|Primary|Number of Seropositive Subjects for Each Influenza Strain|A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1267868|NCT00377611|Primary|Number of Seropositive Subjects for Each Influenza Strain|A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10.|At Day 0 (PRE)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1267869|NCT00377611|Primary|Number of Seroprotected Subjects Against the 3 Influenza Strains|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1267870|NCT00377611|Primary|Number of Seroprotected Subjects Against the 3 Influenza Strains|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.|At Day 0 (PRE)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1267871|NCT00377611|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1267872|NCT00377611|Primary|Number of Seroconverted Subjects for Each Influenza Strain|A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1267873|NCT00377611|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267874|NCT00377611|Primary|Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)|RSV infection was determined by the RT-PCR assay.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267875|NCT00377611|Primary|Number of Subjects With Fatal Outcomes|Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267876|NCT00377611|Primary|Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection|Death due to lab confirmed influenza infection was recorded during the influeza period only.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267877|NCT00377611|Primary|Number of Subjects With Influenza-related Complications|ILI complications refer to episodes of pneumonia, ischemic heart disease [HD] (unstable angina or myocardial infarction), congestive heart failure [HF], acute cerebrovascular disease [ACD] (stroke or transient ischemic attack [IA]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode).|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267878|NCT00377611|Primary|Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications|ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267879|NCT00377611|Primary|Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause|As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1).|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267880|NCT00377611|Primary|Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza|Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267881|NCT00377611|Primary|Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI|ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267882|NCT00377611|Primary|Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B|Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available|||Participants|||Count of Participants
1267883|NCT00377611|Primary|Number of Subjects With at Least One Influenza-like-infection (ILI) Episode|Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (>) 2 episodes) reported.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
1267884|NCT00377572|Secondary|Paediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall Score|"Asthma-specific quality of life (QOL) validated tool designed for children 7 to 17 years of age. PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible score is 1 (maximum impairment); maximum possible score is 7 (no impairment). Actual scores ranged from 2.1 to 7.~PAQLQ scores were available for 338 of 419 (81%) of study participants, 170 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm."|Week 60|Intent-to-treat|||units on a scale||Standard Deviation|Mean
1267885|NCT00377572|Secondary|Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall Score|"Asthma-Specific Quality of Life (QOL) Measure . The PACQLQ is a validated tool that measures limitations and anxieties faced by primary caregivers of children with asthma. Scores are calculated as the mean score within two domains of questions (re: activity limitation and emotional function) and overall scores represent the mean across all questions. The use of the PACQLQ is valid for use in the caretakers of children ages 7 to 17 years of age. Higher scores indicate better quality of life. Minimum possible score is 1 (maximum impairment); maximum possible score is 7 (no impairment). The range of actual scores were a minimum of 2.4 and a maximum of 7.~Method: Caretaker self-report. PACQLQ scores were available for 320 of 419 (76%) of study participant caretakers (159 in the Omalizumab (Xolair) + Conventional Therapy arm)."|Week 60|Intent-to-treat|||units on a scale||Standard Deviation|Mean
1268731|NCT00370682|Secondary|Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose|Incidence of abnormal dengue examination findings reported during the 31-Day (Days 0-30) post-vaccination period, per dose|31 days post-vaccination per dose||||% of subjects||95% Confidence Interval|Number
1267886|NCT00377572|Secondary|Percent Prevalence: Asthma Exacerbations|Percent participants with >=1 exacerbations. An exacerbation was defined as a prednisone burst (a minimum of 20 mg per day of prednisone, or the equivalent, taken for any 3 of 5 consecutive days) or hospitalization. Results values are model predicted numbers, (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||percent prevalence|||Number
1267887|NCT00377572|Secondary|Percent Prevalence: Asthma-Related Medical Care Resource Utilization - Hospitalizations|Percent participants with >=1 hospitalizations. A hospitalization is defined as an asthma-related, overnight hospitalization. . Results values are model predicted numbers,(e.g., odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||percent prevalence|||Number
1267888|NCT00377572|Secondary|Percent Prevalence: Prescribed Rescue Beta 2 Agonists|Percent of participants prescribed long-acting beta 2 agonists to maintain asthma control. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant. Results values are model predicted numbers, (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||percent prevalence|||Number
1267889|NCT00377572|Secondary|Dose Inhaled Corticosteroids (Glucocorticoids)|Prescribed dose (mcg/day) of inhaled glucocorticoids to maintain asthma control. The dose of inhaled glucocorticoids was converted to the budesonide-equivalent dose. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||mcg/day||Standard Error|Least Squares Mean
1267890|NCT00377572|Secondary|Percent Prevalence: Treatment Step Level 4 Through 6 (Severe Asthma)|Steps were established, per the National Asthma Education and Prevention Program Expert Panel Report 3 guidelines. Steps 1-2 apply to mild asthma, 3 to moderate asthma, and 4-6 to severe asthma. At Step 0, the recommendation is for no asthma-control medication or albuterol as needed; at 1, budesonide 180 mcg once a day; at 2, budesonide 180 mcg twice a day; at 3, budesonide 360 mcg twice a day; at 4, fluticasone–salmeterol (Advair, GlaxoSmithKline) 250 mcg fluticasone and 50 mcg salmeterol twice a day; at 5, Advair 250 mcg and 50 mcg twice a day plus montelukast once a day; and at 6, Advair 500 mcg and 50 mcg twice a day plus montelukast once a day. (The doses for montelukast are 5 mg per day for those <=14 years old and 10 mg per day for those >=15 years.) Data represent an average of those in the time period, where at least one value was available in this period and at baseline for a participant. Results values are model predicted numbers,(e.g, odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat|||percent prevalence|||Number
1267891|NCT00377572|Secondary|Percent Prevalence: Treatment Step Level 1 or 2 (Mild Asthma)|Treatment steps were established, per the National Asthma Education and Prevention Program Expert Panel Report 3 guidelines. Steps 1-2 apply to mild asthma, 3 to moderate asthma, and 4-6 to severe asthma. At Step 0, the recommendation is for no asthma-control medication or albuterol as needed; at 1, budesonide 180 mcg once a day; at 2, budesonide 180 mcg twice a day; at 3, budesonide 360 mcg twice a day; at 4, fluticasone–salmeterol (Advair, GlaxoSmithKline) 250 mcg fluticasone and 50 mcg salmeterol twice a day; at 5, Advair 250 mcg and 50 mcg twice a day plus montelukast once a day; and at 6, Advair 500 mcg and 50 mcg twice a day plus montelukast once a day. (The doses for montelukast are 5 mg per day for those <=14 years old and 10 mg per day for those >=15 years.) Data represent an average of those in the time period, where at >/= 1 value was available in this period and at baseline for a participant; results are model predicted numbers (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat|||percent prevalence|||Number
1267892|NCT00377572|Secondary|Percent Adherence to Asthma Medication|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration every 3 months. Adherence data as an outcome were available in 384 of the 419 participants, 193 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat|||percentage of expected dose taken||Standard Error|Least Squares Mean
1267893|NCT00377572|Secondary|Exhaled Nitric Oxide|Exhaled nitric oxide is a biomarker of airway inflammation. Measurement (in parts per billion,ppb) of exhaled nitric oxide (eNO) prior to spirometry, employing a technique modified after Silkoff et al (1997) and following American Thoracic Society guidelines for eNO assessment (American Thoracic Society, 1999). Nitric oxide concentrations were measured using a rapid-response chemiluminescent analyzer (NIOX™ System, Aerocrine, Sweden) which has a response time of < 700 ms for 10-90% full scale. The Food and Drug Administration has approved this device for clinical application in asthma management. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||ppb||Standard Error|Least Squares Mean
1267894|NCT00377572|Secondary|FEV1/FVC Ratio|"The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.~FEV1/FVC ratio data as an outcome measure were available in 363 of the 419 participants, 190 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant."|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Ratio (x100)||Standard Error|Least Squares Mean
1267907|NCT00377455|Primary|Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol.|The total exercise time measured using the exercise echocardiogram is evaluated with the standard Bruce Stress Protocol, and this will be determined after 16 weeks on the study medication.|This will be determined after 16 weeks on the study medication.|||||||
1267895|NCT00377572|Secondary|Forced Expiratory Volume in 1 Second (FEV1) % Predicted|FEV1 is air volume exhaled in 1 second during spirometry. For the trial, mild asthma is defined as pre-bronchodilator FEV1 ≥80% predicted, requiring no/low-moderate dose of inhaled glucocorticoids; moderate asthma and severe asthma, respectively, as pre-bronchodilator FEV1 <80% predicted requiring the same glucocorticoids as mild asthma and FEV1 <80% predicted requiring high-dose inhaled glucocorticoids (with/without continuous oral glucocorticoids) or uncontrolled despite treatment. FEV1 % of predicted is FEV1 converted to a percentage of normal, based on height, weight, and race. FEV1 percent predicted data as an outcome measure were available in 363 of the 419 participants, 190 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Percent||Standard Error|Least Squares Mean
1267896|NCT00377572|Secondary|Asthma Control Test (ACT) Score|The Asthma Control Test (ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients >= 12 years of age. It is a questionnaire comprised of 5 questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores were added together to calculate a total score. Total scores can range from 5 to 25. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference for ACT is 3 points. ACT scores as an outcome measure were available in 150 of the 419 participants, 77 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||ACT score||Standard Error|Least Squares Mean
1267897|NCT00377572|Secondary|Child Asthma Control Test (C-ACT) Score|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined. C-ACT scores were available as an outcome measure in 236 of the 419 participants, 118 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of treatment.|Intent-to-treat|||C-ACT score||Standard Error|Least Squares Mean
1267898|NCT00377572|Secondary|Economic Outcome: Number of Missed Work Days by Caretaker Due to Asthma|The number of work days missed by the caretaker due to the study participant’s asthma was available for 138 of 419 (33%) study participant caretakers. Source of data: caretaker self-report. Data represent an average of those collected in the time period (weeks 12-60).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Days||Standard Error|Least Squares Mean
1267899|NCT00377572|Secondary|Economic Outcome: Comparison of Number of Missed School Days Due to Asthma|The number of school days missed was available for 307 of the 419 (73%) study participants, of which 152 were in the Omalizumab (Xolair) + Conventional Therapy arm. Source of data: caretaker/participant self-report. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Days||Standard Error|Least Squares Mean
1267900|NCT00377572|Primary|Maximum Number of Asthma Symptom Days|Maximum symptom days was calculated as the largest of the following variables: number of days with wheezing, chest tightness, or cough; number of nights of sleep disturbance; and number of days when activities were affected. This symptom scale ranges from 0 to 14 days per a 2-week look-back period. A higher score reflected a greater number of asthma symptoms. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Days||Standard Error|Least Squares Mean
1267901|NCT00377520|Secondary|Number of Participants With Adverse Events by Grade (Measures of Toxicity)|Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.|every 21-day cycle (up to 24 months)||||participants|||Number
1267902|NCT00377520|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 24 months)||||participants|||Number
1267903|NCT00377455|Secondary|Quality of Life (QOL)|QOL is measured using the Short Form 36 Health Survey (SF-36, which measures health on eight dimensions: general health perception, physical and social functioning, role limitations by physical or emotional problems, mental health, vitality, and bodily pain. For each dimension items are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health).|16 weeks|Outcomes not available, due to early termination of study||||||
1267904|NCT00377455|Secondary|Endothelin-1(ET-1) Level|From saved serum to determine Endothelian-1 (ET-1) levels in patients|16 weeks|Outcomes not available, due to early termination of study||||||
1267905|NCT00377455|Secondary|Brain Natriuretic Peptide (BNP) Level|Serum BNP level to evaluate Brain Natriuretic Peptide (BNP) level|16 weeks|Outcomes not available, due to early termination of study||||||
1267906|NCT00377455|Secondary|6-minute Walk Distance|The distance walked during a 6-minute walk test.|16 weeks|Outcomes not available, due to early termination of study||||||
1267985|NCT00376948|Primary|Median Overall Survival Estimate||up to 17 months||||months||90% Confidence Interval|Median
1267908|NCT00377429|Secondary|Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)||3 months|Only 1 patient received 3rd-look laparoscopy/laparotomy as determined by the investigator and no residual disease was found.|||participants|||Number
1267909|NCT00377429|Secondary|Number of Participants Who Survived (Post-study at 24 Month Visit)|Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die|2 years|Post study full analysis set|||participants|||Number
1267910|NCT00377429|Secondary|Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)||2 years|Post study full analysis set|||weeks||Full Range|Median
1267911|NCT00377429|Secondary|Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)||Baseline|2nd look laparoscopy/laparotomy|||Participants|||Number
1267912|NCT00377429|Secondary|Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy|Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.|2 months|Full analysis population|||Participants|||Number
1267913|NCT00377429|Primary|Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days||21 days|Treated population|||Participants|||Number
1267914|NCT00377403|Primary|SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3|The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact).|4 days|We analysed all participants for whom we had data at Day 3. We were unable to complete the telephone interview with 11 subjects.|||Units on a scale||Standard Deviation|Mean
1267915|NCT00377364|Secondary|Asthma Control Questionnaire|This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1267916|NCT00377364|Secondary|Asthma Control Questionnaire (ACQ)|This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).|Baseline||||units on a scale||Standard Deviation|Mean
1267917|NCT00377364|Primary|Young Mania Rating Scale (YMRS)|This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1267918|NCT00377364|Primary|Young Mania Rating Scale (YMRS)|This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).|Baseline||||units on a scale||Standard Deviation|Mean
1267919|NCT00377364|Primary|Hamilton Rating Scale for Depression (HRSD-17)|The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1267920|NCT00377364|Secondary|Internal State Scale - Activation (ISS-ACT)|Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
1267921|NCT00377364|Secondary|Internal State Scale - Activation (ISS-ACT)|Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.|Baseline||||units on a scale||Standard Deviation|Mean
1267922|NCT00377364|Primary|Hamilton Rating Scale for Depression (HRSD-17)|The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).|Baseline||||units on a scale||Standard Deviation|Mean
1267923|NCT00377364|Primary|Rey Auditory Verbal Learning Task (RAVLT)|This is a measure of declarative memory (associated with the hippocampus), using the mean number of words (0-75) recalled from Trials I-V of the RAVLT ± the standard deviation. The assessement was conducted using the same procedures as at baseline. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||words||Standard Deviation|Mean
1267924|NCT00377364|Primary|Rey Auditory Verbal Learning Test (RAVLT)|This is a measure of declarative memory (associated with the hippocampus). The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.|Baseline||||words||Standard Deviation|Mean
1267925|NCT00377312|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|% change from baseline|baseline, daily, one week follow-up||||% change from baseline||Standard Error|Mean
1267926|NCT00377312|Secondary|Amino-terminal Peptides of Procollagen- 1(P1NP)|% change from baseline|baseline, daily, one week follow-up||||% change from baseline||Standard Error|Mean
1267927|NCT00377312|Secondary|Serum Carboxy-terminal of Collagen- 1(sCTX)|% change from baseline|baseline, daily, one week follow-up||||% change from baseline||Standard Error|Mean
1267928|NCT00377312|Secondary|Serum Amino-terminal of Collagen- (sNTX)|% change from baseline|baseline, daily, one week follow-up||||% change from baseline||Standard Error|Mean
1267929|NCT00377312|Secondary|Tubular Maximum for Phosphorous|mg/dl|baseline and daily||||mg/dl||Standard Error|Mean
1267930|NCT00377312|Secondary|24 Hour Urine Calcium|mg/gm creatinine|24 hours period from Day 7 to Day 8||||mg/gm creatinine||Standard Error|Mean
1267931|NCT00377312|Secondary|Fractional Excretion of Calcium|% = (S Creatinine X U Calcium)/(S Calcium X U Creatinine)|baseline and daily||||% of excretion||Standard Error|Mean
1267932|NCT00377312|Secondary|Parathyroid Hormone (1-84)|pg/ml|baseline, daily up to Day 8 and follow-up||||pg/ml||Standard Error|Mean
1267933|NCT00377312|Secondary|1,25 Vitamin D|pg/ml|baseline, daily up to Day 8 and follow-up||||pg/ml||Standard Error|Mean
1267934|NCT00377312|Primary|Serum Phosphorous|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
1267935|NCT00377312|Primary|Ionized Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
1267936|NCT00377312|Primary|Total Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
1267937|NCT00377312|Primary|Participants With Dose Limiting Toxicity|DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall >30 mm/hg), tachycardia (pulse > 120), hypertension (systolic BP >160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous < 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.|12 hours after the infusion was started then q 8 hours for 7 days||||participants|||Number
1267938|NCT00377299|Secondary|Stroop Color Word Test|The Stroop Color Word Test measures the individual's ability to separate the word and color naming stimuli thus the ability to sort information from the environment and selectively react to this information. The scoring is a measure of time to complete 100 items and the numbers of items that can be completed. THe scores are converted into T-scores which have a mean of 50 and a standard deviation of 10.|12 weeks||||T score||Standard Error|Mean
1267939|NCT00377299|Secondary|Hopkins Auditory Verbal Learning Test (HVLT)|The Hopkins Auditory Verbal Learning Test (HVLT) is a measure of cognition (memory/recall). Raw scores are derived for Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index. Raw scores are calculated into T-scores. T-scores are standardized scores on each dimension for each type. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean.|12 weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.|||T score||Standard Error|Mean
1267940|NCT00377299|Secondary|Amphetamine Use|Participant reported days per 7-day week of methamphetamine use.|12 weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.|||days per week||Standard Error|Mean
1267941|NCT00377299|Secondary|Amphetamine Craving|Visual Analog Scale (VAS) assessing Methamphetamine craving with a 1-100 scale.Higher values on the VAS scale indicate a higher Methamphetamine craving(worse outcome).|12 Weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.|||scores on a scale||Standard Error|Mean
1267942|NCT00377299|Primary|Depression Symptoms|Inventory of Depressive Symptomatology-Clinician Rated (IDS-C), (a clinician-administered depression scale) is used to assess the severity of depressive symptoms.Scores can range from 0 to 84. The higher the score, the worse the depressive symptoms(worse outcome).|12 weeks|The intent to treat (ITT) group includes all who returned for at least one post baseline visit. Analysis uses Last Observation Carried Forward (LOCF) method.|||scores on a scale||Standard Error|Mean
1267986|NCT00376948|Primary|Patients Alive||at 6 months||||participants|||Number
1267987|NCT00376935|Secondary|Number of Death From Randomization to Week 24|Number of subjects died.|From randomization to week 24||||participants|||Number
1271443|NCT00349466|Secondary|Proportion of Clinical Success|improvement of ≥25% over baseline at Week 12 in BUT, superficial punctate keratitis as assessed by FS, or ST|12 weeks|||||||
1267943|NCT00377260|Primary|The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment|The AOM-SOS score is derived from parent scoring each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) associated with AOM as 0, 1 or 2 (none, a little, a lot). The AOM-SOS was administered twice daily the first 3 days of follow-up, then daily for 4 additional days. Symptom burden for each child is determined by calculating the weighted average of symptom scores post-enrollment over the first 7 days of therapy. Scores are weighted by 1/k, where k is the number of post-enrollment assessments taken on that day.|During the first 7 days of therapy|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on diaries completed at home by the child's parent.|||AOM-SOS score||Standard Error|Mean
1267944|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the follow-up visit.|||parental satisfaction score||Standard Deviation|Mean
1267945|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the end-of-therapy visit.|||parental satisfaction score||Standard Deviation|Mean
1267946|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the on-therapy visit.|||parental satisfaction score||Standard Deviation|Mean
1267947|NCT00377260|Secondary|The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment|At each visit, parent or parents were asked if their child's illness had caused them to make alternative daycare arrangements. The total number of visits is summed across all participants in the respective treatment arms.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.|||visits|||Number
1267948|NCT00377260|Secondary|The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment|At each visit, parent or parents were asked if their child's illness had caused either parent to miss a day or partial day of work. The total number of visits is summed across all participants in the respective treatment arms.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.|||visits|||Number
1267949|NCT00377260|Secondary|The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment|This is the number of times, in the course of the study, a child required treatment with an antibiotic other than the blinded study medication.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up.|||antibiotic prescriptions||Standard Deviation|Mean
1267950|NCT00377260|Primary|The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment|Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches <= 1 on two consecutive occasions. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) & recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 & 3, & once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible was 14 and the minimum 0. A score >=3 was required to be enrolled in the study.|The first 7 days on therapy||||participants|||Number
1267951|NCT00377260|Primary|The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment|Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score >=3 was required to be enrolled in the study.|The first 7 days on therapy|The analysis was ITT. The number of participants is equal to the number of children randomized.|||participants|||Number
1267952|NCT00377260|Secondary|The Mean Number of Emergency Room Visits According to Treatment Assignment|At each visit we asked parents if they had to take their child to the emergency department. We also reviewed medical records to assure even more accurate reporting.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.|||visits to ER||Standard Deviation|Mean
1267953|NCT00377260|Secondary|The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment|At each visit parents were asked if they had taken their child to his/her primary care physician since the last contact. Medical records were also reviewed.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.|||visits to PCP||Standard Deviation|Mean
1267954|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.|||probability of effusion||Standard Deviation|Mean
1267955|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the end-of-therapy visit.|||probability of effusion||Standard Deviation|Mean
1267956|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the on-therapy visit.|||probability of effusion||Standard Deviation|Mean
1267957|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit||Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the follow-up visit.|||participants|||Number
1267958|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment|AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the follow-up visit.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children with NP culture results at the follow-up visit.|||participant|||Number
1267959|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment||End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the end-of-therapy visit.|||participants|||Number
1267960|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment|AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the end of therapy visit.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children with NP culture results at the end-of-therapy visit.|||participants|||Number
1267961|NCT00377260|Secondary|The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment|Analysis was limited to those adverse events identified as being associated with either the study medication or the antimicrobials administered to children who were treatment failures or as being a complication of acute otitis media.|We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children randomized.|||participants|||Number
1267962|NCT00377260|Secondary|The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment|The parents were asked to complete a memory aid for the first 10 days of the study. One item asked them to record medications administered to the child in addition to the study medication. The data presented shows the mean number of times analgesic, i.e. ibuprofen or acetaminophen, was administered.|The first 10 days of follow-up|The analysis was ITT. The participants for analysis were the children with follow-up.|||times analgesic was administered||Standard Deviation|Mean
1267988|NCT00376935|Secondary|Grade 3 or 4 Lab Toxicities From Randomization to Week 24|Number of subjects had a grade 3 or 4 toxicity for laboratory abnormalities. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.|From randomization to study week 24||||participants|||Number
1268507|NCT00371865|Secondary|West Haven-Yale Multidimensional Pain Inventory - Activity Subscales|This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
1267963|NCT00377260|Secondary|The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment|The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1 and twice daily Days 2 and 3. Each set of ratings was summed to obtain an Acute Otitis Media-Severity of Symptoms (AOM-SOS) score. We compared a child's AOM-SOS scores in the first 72 hours to his/her score at enrollment to determine if a child's symptoms got worse (score increased) or remained unchanged or improved (score remained same or decreased).|Before receiving 72 hours of study medication|The analysis was ITT. The number of participants equals the number of children with follow-up whose parent(s) recorded AM and/or PM symptom scores in the first 3 days of treatment.|||Participants|||Number
1267964|NCT00377260|Secondary|The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment|The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. The maximum possible score was 14 and the minimum was 0.|During the first 7 days of therapy|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on AM and PM diaries completed at home by the child's parent.|||AOM-SOS score||Standard Deviation|Mean
1267965|NCT00377260|Secondary|The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment|Clinical failure by the end of therapy visit is defined as failure to achieve complete or virtually complete resolution of symptoms and of otoscopic signs, but without regard to the persistence of middle ear effusion.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children evaluated post therapy plus the number of children who met the criteria for clinical failure prior to the end of therapy.|||participants|||Number
1267966|NCT00377260|Secondary|The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment|Clinical failure by the on-therapy visit is defined as either failure to achieve substantial improvement in symptoms, or worsening of otoscopic signs, or both.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children followed at least 72 hours after the initial dose of study medication plus the number of children meeting the criteria for clinical failure less than 72 hours after the initial dose of study medication.|||participants|||Number
1267967|NCT00377234|Secondary|Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)|During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.|3 months|Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.||||||
1267968|NCT00377234|Secondary|Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)|During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.|3 months|Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.||||||
1267969|NCT00377234|Secondary|Intensity of Upper Gastrointestinal (GI) Symptoms|Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.|within 3 months|Safety analysis set|||percentage of participants|||Number
1267970|NCT00377234|Secondary|Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate|Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.|within 6 months|mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment|||percentage of participants|||Number
1267989|NCT00376935|Secondary|Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.||randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24|This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.|||cells/mm^3||Inter-Quartile Range|Median
1267971|NCT00377234|Primary|Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing|Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.|at 6 months|Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment|||percentage of participants|||Number
1267972|NCT00377156|Secondary|Overall Survival|Overall survival, defined as the time from randomization until death due to any cause, was compared between the groups using stratified log-rank tests.|Up to 5 years|A survival comparison was performed on an intention-to-treat basis using the entire study population.|||months||Full Range|Median
1267973|NCT00377156|Secondary|Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months|Long-Term Neurocognitive Status > To ascertain in patients with one to three brain metastases whether there is better long-term neurocognitive status in patients who receive SRS alone (Arm A) compared to patients who receive SRS combined with WBRT (Arm B). Long-term survival status is defined as evaluable patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days.|From baseline to 12 months|Patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days were included in this analysis.|||percentage of participants|||Number
1267974|NCT00377156|Secondary|Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month]|Quality of Life was assessed using the Functional Assessment of Cancer Therapy-Brain, for which the range is from 0 to 200 and higher scores indicate better QOL. The Quality of Life (QOL) scores were transformed to a 0- to 100-point scale (with 100 being most favorable), in which a 10-point change was considered clinically significant. Intergroup changes in QOL scores were compared using a 2-sample t test.|From Baseline to 3-Month Evaluation|All patients in the SRS and SRS+WBRT groups that had a baseline and 3-month QOL score were used in this analysis.|||QOL score change from baseline points||95% Confidence Interval|Mean
1267975|NCT00377156|Secondary|Number of Participants With Local and Distant Tumor Control up to 3 Months|Number of Participants with Local and Distant Tumor Control up to 3 months is defined as....|Up to 3 months||||Participants|||Count of Participants
1267976|NCT00377156|Primary|Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months|The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fisher exact 2-group binomial test was used to compare the proportion of evaluable patients with 3-month cognitive deterioration between the 2 groups.|3 months post radiosurgery|Patients who died prior to the 3-month evaluation, who did not return for the 3-month evaluation or a subsequent evaluation, or who did not complete the required baseline tests were excluded from the analysis population for the primary end point.|||Participants|||Count of Participants
1267977|NCT00376961|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1267978|NCT00376961|Secondary|2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)|Measured from date of registration to date of death due to any cause or last contact|0-2 years|All eligible patients who started treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1267979|NCT00376961|Primary|2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)|Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.|0-2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1267980|NCT00376961|Secondary|Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment|All eligible patients who started treatment were included in the analysis.|||participants|||Number
1267981|NCT00376948|Secondary|pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation|Tumor tissue collected from paraffin|At start of study|||||||
1267982|NCT00376948|Secondary|Toxicity|Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9|First day of each cycle|||||||
1267983|NCT00376948|Secondary|Response Duration, Time to Treatment Failure, and Time to Progression|Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated|Every 8 weeks|||||||
1267984|NCT00376948|Secondary|Overall Objective Response Rate (Complete and Partial Response)|Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated|Every 8 weeks|||||||
1267990|NCT00376935|Secondary|Change in CT Thymic Index From Randomization|CT thymic index was evaluated at randomization and study week 12, ranging from 0 to 5 whereby 0 means lack of thymic tissue and an organ entirely replaced by fat, 1 means barely recognizable thymic tissue, 2 means minimal soft tissue, 3 means obvious thymic tissue, 4 means moderate thymic tissue, 5 means thymic mass of possible concern for thymoma. Change in CT thymic index from randomization to study week 12 was calculated for participants with both evaluations. The number of participants in each change group was reported by treatment arm.|randomization, study week 12|Participants who had CT thymus evaluations at both randomization and study week 12.|||participants|||Number
1267991|NCT00376935|Secondary|Change in Naive CD4+ Cell Counts From Randomization||randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24|This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.|||cells/mm^3||Inter-Quartile Range|Median
1267992|NCT00376935|Secondary|Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24|Number of subjects had a grade 3 or 4 toxicity for signs and symptoms. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.|From randomization to week 24|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||participants|||Number
1267993|NCT00376935|Secondary|Qualitative Hepatitis C Virus RNA||At study entry||||participants|||Number
1267994|NCT00376935|Primary|Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)|Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.|Pre-entry, entry, study week 12|Numbers presented use the intent-to-treat.|||cells/mm^3||Inter-Quartile Range|Median
1267995|NCT00376805|Secondary|Overall Median Number of Days Patients Alive After Treatment|Calculated median number of days of survival (patients alive days after treatment).|First Day of Treatment Until Death||||Days||95% Confidence Interval|Median
1267996|NCT00376805|Secondary|Number of Patients Who Died While on Study|Number of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation.|Within 100 days, After 100 days||||Participants|||Number
1267997|NCT00376805|Secondary|Number of Patients by Disease Response|"Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria:~Complete Response (CR: Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions of appearance of one or more new lesions~of clinical benefit (CB; stable disease for greater than 6 months."|6 Months, 1 Year||||Participants|||Number
1267998|NCT00376805|Primary|Number of Patients Who Had Expansion of Natural Killer Cells|Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of >100 cells/ul of whole blood 14 days after infusion with <5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).|Day 14||||Participants|||Number
1267999|NCT00376688|Primary|Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)|"Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.~Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;~Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits"|Up to 24 months||||percentage of participants|||Number
1268000|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."|||Units on scale||Standard Deviation|Mean
1268001|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."|||Units on scale||Standard Deviation|Mean
1268508|NCT00371865|Primary|Brief Pain Inventory|This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
1268002|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."|||units on a scale||Standard Deviation|Mean
1268003|NCT00376675|Secondary|AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4|Area under the curve (AUC) for the other fatigue items of the BFI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline BFI score were evaluable for this analysis.|||units on a scale * weeks||Standard Deviation|Mean
1268004|NCT00376675|Secondary|AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4|Linear Analogue Self Assessment (LASA) consists of 6 single-item numeric analogue scales. The AUC for the six-items at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline LASA score were evaluable for this analysis.|||units on a scale * weeks||Standard Deviation|Mean
1268005|NCT00376675|Secondary|AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4|The SF-36 is a 36-item short form to measure health status in various populations. The vitality subscale is comprised of 4 items and is a measure of energy level as well as fatigue. The AUC for the vitality subscale at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline Vitality subscale score were evaluable for this analysis.|||units on a scale * weeks||Standard Deviation|Mean
1268006|NCT00376675|Secondary|AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4|Pittsburgh Sleep Quality Index (PSQI) consists of 19 items and 7 scales. The AUC for the overall PSQI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline PSQI score were evaluable for this analysis.|||units on a scale * weeks||Standard Deviation|Mean
1268007|NCT00376675|Secondary|Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4|The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4.|Baseline and Week 4|All participants who have provided a baseline and week 4 SED scores were evaluable for this analysis.|||units on a scale||Standard Deviation|Mean
1268008|NCT00376675|Primary|Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4|"The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following:~For those completed 4 weeks item: AUC/4;~For those completed up to week 3 item: (AUC * 4) / 3;~For those completed up to week 2 item: AUC * 2;~For those completed up to week 1 item: AUC * 4;~The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis."|Baseline to week 4|All participants meeting the eligibility criteria who have signed a consent form, started treatment, and provided a baseline and one post-baseline usual fatigue score were evaluable for this analysis.|||units on a scale||Standard Deviation|Mean
1268009|NCT00376597|Secondary|Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength|To characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion. The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here. Arm I did not receive a sleeve to wear, thus will not be reported.|from baseline up to 18 months|236 patients were analyzed for this endpoint.|||Participants|||Count of Participants
1268010|NCT00376597|Secondary|Health-related Quality of Life as Assessed by FACT-B +4 Score|To compare the health-related quality of life (FACT-B+4 score) between the two interventions. The change between baseline and month 18 for the total plus 4 score will be reported here. The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales. Each sub-scale has questions ranging from 1-5. Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.|18 months|326 patients were analyzed for this measurement.|||Units on a scale||Standard Deviation|Mean
1268011|NCT00376597|Secondary|Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm|To assess the agreement between patients’ self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference. Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.|18 months|368 patients filled out a self assessment of swelling and were analyzed. This includes all patients that filled out a self-report of swelling, the two arms are combined because this is a comparison of actual swelling against self reported swelling, not a comparison of interventions.|||Participants|||Count of Participants
1268012|NCT00376597|Secondary|Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference|To compare the severity of lymphedema in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.|18 months|402 patients were analyzed for this endpoint.|||cubic cm||Standard Deviation|Mean
1268013|NCT00376597|Primary|Number of Participants Who Were Lymphedema-free 18 Months After Randomization|To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms|18 months|554 patients completed treatment and were analyzed.|||Participants|||Count of Participants
1268014|NCT00376558|Secondary|Cocaine Craving, Withdrawal Symptoms, Pattern of Cocaine Use|measurement of abstinence, measured as vouchers earned and clinical appointments attended using CRA|2x/week for 24 weeks|The number of subjects was determined from previous studies using CM/CRA|||dollars||Standard Deviation|Mean
1268015|NCT00376558|Primary|Change From Baseline in the Binding Potential of [11C]Raclopride|The relationship between Methylphenidate-induced Dopamine Release in the Striatum (Measured by Displacement of [11C]-Raclopride by Oral Methylphenidate) and Treatment Response (Measured Using Community Reinforcement Approach and Contingency Management) was studied. Dopamine Function was assessed by evaluation of endogenous Dopamine release over the course of treatment (i.e., at 3 months as compared to baseline). Endogenous Dopamine release is inversely related to the change in binding potential (delta BPND) of [11C]raclopride, in that a negative delta BPND, or increased displacement of [11C]raclopride, reflects an increase in the release of endogenous dopamine over the course of treatment.|baseline and 3 months|Analysis for change in binding potential (binding potential difference; at baseline versus stimulant induced binding potential) was done with 24 cocaine users since one of the subjects only underwent baseline scanning. However, treatment data for all 25 cocaine users was used.|||ratio||Standard Deviation|Mean
1268016|NCT00376532|Primary|MMP-9|Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.|At time of enrollment||||pg/ml||Standard Deviation|Mean
1268017|NCT00376532|Primary|MMP-2|Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.|At time of enrollment||||pg/ml||Standard Deviation|Mean
1268018|NCT00376506|Secondary|Quality of Life Patient Questionnaire|The SWAL-QOL (Swallowing Quality of Life) questionnaire was administered at baseline and every 3 months during the first year. The SWAL-QOL is a 44 item tool that measure 10 quality of life domains, i.e., food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Scores range from 0 to 100. A lower score indicates greater impairment.|Baseline and 12-months post-treatment|intention to treat|||units on a scale||Standard Deviation|Mean
1268019|NCT00376506|Secondary|Functional Oral Intake Scale (FOIS) for Dysphagia|The FOIS was administered at baseline and every 3 months post-treatment during the first year. The FOIS is a 7 point ordinal scale reflecting the functional oral intake of patients. A score of 1 indicates no oral nutrition; a score of 7 indicates all nutrition is taken orally.|Baseline and 12-months post-treatment|intention to treat|||units on a scale||Standard Deviation|Mean
1268020|NCT00376506|Primary|Swallowing Safety for 5 ml of Pudding|Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of >1 swallow per bolus. Scores range from 0 (safe swallowing) to >5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.|Baseline and 12-months post-treatment|intention to treat|||Units on a scale||Standard Deviation|Mean
1268021|NCT00376506|Secondary|Penetration-Aspiration Scale for 5 ml Pudding|Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 5 ml pudding, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.|Baseline and 12-months post-treatment|intention to treat|||units on a scale||Standard Deviation|Mean
1268022|NCT00376506|Secondary|Penetration-Aspiration Scale for 10 ml Thin Liquid|Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.|Baseline and 12-months post-treatment|intention to treat|||units on a scale||Standard Deviation|Mean
1268023|NCT00376506|Primary|Swallowing Safety for 10 ml of Thin Liquid|Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of >1 swallow per bolus. Scores range from 0 (safe swallowing) to >5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.|Baseline and 12-months post-treatment|Intention to treat|||units on a scale||Standard Deviation|Mean
1268057|NCT00375752|Secondary|Change From Baseline in Tumor Size (Longest Diameter) at Month 6|Tumor size (sum of longest diameter)was analyzed based on the diameters values provided with the central review.|Baseline, Month 6|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.|||cm||Standard Deviation|Mean
1268024|NCT00376363|Secondary|Visual Acuity|Snellen chart converted to logMAR (smaller logMAR values indicate better visual acuity logMar of 0 is Snellen 20/20; logMAR of 20/200 is 1.0)|5 years|"The failure rate is based on Kaplan Meier analysis of all patients enrolled (n=276).~The five-year intraocular pressure and visual acuity outcomes are based on those patients who received a five-year visit (n=174 for IOP; n=173 for visual acuity, 1 patient had missing data)"|||logMAR||Standard Deviation|Mean
1268025|NCT00376363|Primary|Failure Rate|5-year failure rate measured by Kaplan-Meier, defined as IOP>21 mm Hg or less than a 20% reduction below baseline on 2 consecutive study visits after 3 months, reoperation for glaucoma, loss of light perception, or removal of implant|5 years|Kaplan-Meier survival analysis|||percent fail|||Number
1268026|NCT00376363|Primary|Intraocular Pressure|intraocular pressure mmHg at 5 years|5 years||||mm Hg||Standard Deviation|Mean
1268027|NCT00376259|Secondary|Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough|The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.|Week 96||||Proportion of Participants|||Number
1268028|NCT00376259|Secondary|Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria|Undetectable HBV DNA = HBV DNA <300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.|12 week, 24 week, 48 week and 60 weeks|Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation for that timepoint.|||Percentage of participants|||Number
1268029|NCT00376259|Secondary|Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration|Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.|Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks|Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation.|||Log10 Copies/mL||Standard Deviation|Mean
1268030|NCT00376259|Primary|The Proportion of Participants Who Experienced Virologic Breakthrough|Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.|96 Weeks|This study was terminated early and no patients received 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.|||Proportion of participants|||Number
1268031|NCT00376220|Primary|Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy.|The Montgomery Asberg Depression Rating Scale measures symptoms of depression (MADRS) is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions with a fixed 7 point scale (0-6). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response will be defined as a > 50% reduction in MADRS score from baseline.|8 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.|||units on a scale||Standard Deviation|Mean
1268032|NCT00376168|Other Pre-specified|Change in Chitotriosidase|Change in Chitotriosidase from Baseline to Month 9|Baseline and Month 9|Intent to treat|||nmol/ml/hr||Standard Deviation|Mean
1268033|NCT00376168|Secondary|Change in Platelet Count|Change in Platelet count from Baseline to Month 9|Baseline and Month 9|Intent to treat|||count/mm^3||Standard Deviation|Mean
1268034|NCT00376168|Secondary|Change in Hemoglobin|Absolute change in Hemoglobin concentration from Baseline to Month 9|Baseline and Month 9|Intent to treat|||g/dL||Standard Deviation|Mean
1268035|NCT00376168|Secondary|Change From Baseline in Liver Volume|Calculated as percent change in liver volume from Baseline to 9 months|Baseline and 9 months|Intent to treat|||percentage of change from baseline||Standard Deviation|Mean
1268036|NCT00376168|Primary|Change From Baseline in Spleen Volume Measured by MRI.|Calculated as percent change in spleen volume from Baseline to 9 months|Baseline and 9 months|Intent to treat|||percentage of change||Standard Deviation|Mean
1268037|NCT00375999|Primary|Overall Survival||One year||||month||95% Confidence Interval|Median
1268038|NCT00375973|Secondary|Number of Participants Who Discontinued Use of Treatment Due to Adverse Events|Paticipants who dropped out of the study because of intolerable adverse events.|Any time after randomization up to 12 weeks.|One patient in the duloxetine group did not have post-baseline data.|||participants|||Number
1268039|NCT00375973|Secondary|Number of Participants Who Discontinued the Study for Any Reason|Description of discontinuation rates of participants; all participants who dropped out of the study after randomization were included. The reasons for drop outs included lack of efficacy, adverse event, lost to follow-up, personal conflict or other patient decision, withdrawal of informed consent, and non-compliance.|Any time after randomization up to 12 weeks.||||participants|||Number
1268040|NCT00375973|Secondary|Patient Global Impression of Improvement (PGI-I)|Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.|baseline to endpoint at 12 weeks.|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
1268079|NCT00375518|Primary|Determine the Postoperative Complications Found in Each Group|To determine whether one week of preventive therapy with atorvastatin prior to surgery and one week after surgery reduced the composite rate of cardiovascular morbidity when compared to placebo.|one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery||||participants|||Number
1268041|NCT00375973|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S)|Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.|baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
1268042|NCT00375973|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale|The HADS is a self-reported instrument designed as a brief assessment tool of anxiety and depression in nonpsychiatric populations. It is a 14-item questionnaire that consistes of 2 subscales of 7 items designed to measure levels of both anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater levels of anxiety or depression. A decrease in the score indicates improvement.|baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
1268043|NCT00375973|Secondary|Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score|The BPI is a self-administered scale that measures the severity of pain. Pain severity is rated on a 0 [no pain] to 10 [pain as bad a you can imagine] scale. Average pain is rated over the previous 24 hours. Higher scores indicate greater pain severity. A decrease in the score indicates improvement (i.e. decrease in pain severity).|Baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
1268044|NCT00375973|Primary|Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score|"The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement.~The general fatigue subscale (primary measure) includes general statements about tiredness, feeling rested, and overall feelings of being fit."|Baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
1268045|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 3|Day 3 data reflect the use of rescue medication only up to the time of discharge.|Day 3||||participants|||Number
1268046|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 2||Day 2||||participants|||Number
1268047|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 1||Day 1||||participants|||Number
1268048|NCT00375934|Secondary|Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|Number of participants analyzed includes only the number of participants with at least 30% reduction in pain intensity after first dose of study drug (see previous outcome measure #7).|||minutes||95% Confidence Interval|Median
1268049|NCT00375934|Secondary|Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose||||participants|||Number
1268050|NCT00375934|Secondary|Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug|Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.|8 hourse post single dose||||units on a scale||Standard Deviation|Mean
1268051|NCT00375934|Secondary|Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1||8 hours post single dose|"Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure #4).~Number of patients in the placebo group is intentionally blank as the data (eg., median and upper CI) were not calculable (see post-hoc outcome measure #12 for available placebo results)."|||minutes||95% Confidence Interval|Median
1268052|NCT00375934|Secondary|Number of Patients With Meaningful Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose||||participants|||Number
1268053|NCT00375934|Secondary|Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1||8 hours post single dose|Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous outcome measure #2).|||minutes||95% Confidence Interval|Median
1268054|NCT00375934|Secondary|Number of Patients With Perceptible Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose||||participants|||Number
1268055|NCT00375934|Primary|Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy|Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain|Over 48 hours after bunionectomy||||units on a scale||Standard Deviation|Mean
1268056|NCT00375752|Secondary|Mean Changes From Baseline in FACT-B Total Score at 6 Months (ITT, Data as Observed)|"The FACT-B total score is calculated by summing all five unweighted subscale scores, with total scores in the range of 0–144.To Derive a FACT-B total score: all sections added together The higher the score the better the QoL~+ __________ + __________ + __________ + __________ =________=FACT-B Total score (PWB score) (SWB score) (EWB score) (FWB score) (BCS score)"|baseline and 6 mos|ITT|||score on a scale||Standard Deviation|Mean
1268058|NCT00375752|Secondary|Number of Patients With Breast Conserving Surgery at 6 Months||Every 6 months|The intent-to-treat (ITT) population included all patients of the safety population for whom at least one post-baseline assessment of tumor response according to the modified RECIST (local or central assessment) was available. During different time points, participants with observations at that timepoint were included in the analysis.|||Participants|||Number
1268059|NCT00375752|Secondary|Best RECIST Response Based on Central Review at 6 Mos|Best response is defined as the best response the patients has reached during the 6 months of treatment. Response Evaluation Criteria in Solid Tumors (RECIST) has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet criteria.|6 Months|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.|||Participants|||Number
1268060|NCT00375752|Primary|Tumor Response Rate (Complete Response (CR) or Partial Response (PR)) Based on MRI- or Mammography and/or Sonography According to Modified RECIST Criteria at Month 6|Sum of longest diameter for all target lesions was reported as baseline sum LD. Baseline sum LD was used as reference to characterize objective tumor response. Response Evaluation Criteria in Solid Tumors has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response)= 30% decrease in sum of longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD(stable disease)=small changes that do not meet criteria. Analysis was underpowered due to insufficient recruitment rate.|6 months|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.|||percentage of participants||95% Confidence Interval|Number
1268061|NCT00375713|Secondary|Global Improvement at Endpoint During the 14 Day Treatment Period|Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.|At endpoint during the 14 day treatment period|All patients in modified ITT except 1 patient in levocetirizine group and 3 patients in cetirizine group who have missing values.|||Participants|||Number
1268062|NCT00375713|Secondary|Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period|Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.|At endpoint during the 14 day treatment period|All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.|||Units on a scale||Standard Error|Mean
1268063|NCT00375713|Secondary|Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period|The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.|Baseline and at endpoint during the 14 day treatment period|All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.|||Units on a scale||Standard Error|Mean
1268064|NCT00375713|Primary|Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).|A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.|Day 7 and 14|The modified ITT population is defined as all randomized patients who received the study drug, except the patients who did not meet the entry criteria, took prohibited medication during the study period, did not have any available data for efficacy evaluation and who were enrolled with packing errors.|||Participants|||Number
1268065|NCT00375674|Secondary|Number of Participants With Tolerability Symptoms|"Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later.~The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent. This table provides the summary of discontinuations de to adverse events. Participants were counted only once in each row."|Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Number of participants|||Number
1268066|NCT00375674|Secondary|PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ‑VAS) Observed Means|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. The first part assessed the current health state. In this outcome measure, the second part was applied to assess the general health status by using visual analog scale (EQ-5D VAS) which measured participant's self-rated health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a different drug from that to which they were randomized. Here, ‘Number analyzed’ signifies the number of participants evaluable at specified time-points.|||Units on a scale||Standard Error|Mean
1268509|NCT00371839|Primary|Ability to Understand Speech in Noise Background|Measure speech perception for sentences in background noise|one year||||Percent correct of 100 presented words||Standard Deviation|Mean
1268067|NCT00375674|Secondary|PROs- EuroQoL EQ‑5D Observed Means – Intent to Treat Population|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. In this outcome measure, the first part with 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, & anxiety/depression) was used; a participant was asked to rate each state on a 3-level scale (1=no problem, 2=some problem, & 3=extreme problem); higher levels indicated greater severity/impairment. The published weights allowed the creation of a single summary score called the EQ-5D index, which ranged from −0.594 to 1; low scores represented a higher level of dysfunction & 1 as perfect health.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a different drug from that to which they were randomized. Here, ‘Number analyzed’ signifies the number of participants evaluable at specified time-points.|||Units on a scale||Standard Error|Mean
1268068|NCT00375674|Secondary|PROs- EORTC QLQ‑C30: Symptom Scale Scores Between Treatment Comparison|PROs assessed health-related QoL by using the EORTC QLQ-C30, which was a 30 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from “not at all” to “very much” to assess symptoms. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented more severe symptoms.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Scores on scale||95% Confidence Interval|Mean
1268069|NCT00375674|Secondary|PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale & 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning). The questionnaire includes 28 items with 4-point Likert type responses from “not at all” to “very much” to assess functioning; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Scores on scale||95% Confidence Interval|Mean
1268070|NCT00375674|Secondary|Patient‑Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale, 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from “not at all” to “very much” to assess functioning & symptoms; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL & more severe for symptoms.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a different drug from that to which they were randomized. Here, ‘Number analyzed’ signifies the number of participants evaluable at specified time-points.|||Scores on scale||Standard Error|Mean
1268071|NCT00375674|Secondary|Summary of Duration of Treatment‑Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)|"TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.~Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later.~The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent."|Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later|"AT population: All participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received.~The numbers of participants analyzed were the participants with any adverse event of special interest (AESI) and that one participant could have reported more than one AESI"|||Weeks||Standard Deviation|Mean
1268080|NCT00375505|Secondary|Change in Inhibin A and Inhibin B From Baseline to Month 24|Change in Inhibin A and Inhibin B from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||pg/ml||Standard Deviation|Mean
1268081|NCT00375505|Secondary|Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24|Change in anti-Mueller hormone (AMH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/ml||Standard Deviation|Mean
1268072|NCT00375674|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity|"TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.~Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent."|Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be “chronic” or “stable,” whichever was later|The As-Treated (AT) population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. This population was the primary population for evaluating treatment administration/ compliance and safety.|||Number of participants|||Number
1268073|NCT00375674|Secondary|Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)|OS was defined as the time from the date of randomization to the date of death due to any cause.|Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Year||95% Confidence Interval|Median
1268074|NCT00375674|Primary|DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]|"DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites.~Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses.~Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the participants had withdrawn consent.~According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized."|Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Number of years||95% Confidence Interval|Median
1268075|NCT00375674|Primary|Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review|DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by blinded independent central review (BICR) or investigator assessment for respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for remainder of follow-up period unless the participant had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.|Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later.|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Number of years||95% Confidence Interval|Median
1268076|NCT00375609|Secondary|Incidence of Adjudicated Pulmonary Embolism (PE) and All Deep Vein Thrombosis (DVT) (Proximal and Distal)|Incidence of adjudicated pulmonary embolism (PE) and all deep vein thrombosis (DVT) (proximal and distal) through the time of venography on Day 10 to 14 and at follow-up at approximately 6 (±2) weeks after TKR surgery|At follow-up at approximately 6 (±2) weeks after TKR surgery|All randomized patients who took at least 1 dose of study medication after randomization and for whom an evaluable venogram was available|||Percentage of Participants||95% Confidence Interval|Number
1268077|NCT00375609|Primary|Incidence of Adjudicated Overt Bleeding Events: Primary Safety Endpoint|The incidence of adjudicated major and clinical relevant non-major bleeding. Major bleeding was defined as fatal, involving vital organs, requiring additional surgery or a new therapeutic procedure, or a bleeding index >=2. Bleeding Index was defined as the number of units of packed red blood cells or whole blood transfused plus the haemoglobin values before the bleeding episode minus the haemoglobin values after the bleed had stabilized (in g/dL)|Through follow-up at approximately 6 (±2) weeks after TKR surgery|All randomized patients who took at least 1 dose of study medication after randomization.|||Percentage of Participants||95% Confidence Interval|Number
1268078|NCT00375609|Primary|Incidence of Adjudicated Venous Thromboembolism (VTE)|Incidence of adjudicated venous thromboembolism (VTE) through Day 10-14 following TKR where VTE is defined as DVT (proximal and/or distal) and/or PE. Patients were evaluated for VTE daily while hospitalized and were contacted every 2 to 4 days after discharge and before the day of the mandatory venogram to monitor for study endpoints|Through Day 10-14 following TKR surgery, at time of mandatory venogram|All randomized patients who took at least 1 dose of study medication after randomization and for whom an evaluable venogram was available|||Percentage of Participants||95% Confidence Interval|Number
1268082|NCT00375505|Secondary|Change in Vitamine D From Baseline to Month 24|Change in Vitamine D from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/ml||Standard Deviation|Mean
1268083|NCT00375505|Secondary|Change in Parathyroid Hormone (PTH) From Baseline to Month 24|Change in Parathyroid Hormone (PTH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||pg/ml||Standard Deviation|Mean
1268084|NCT00375505|Secondary|Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24|Change in Sex Hormone binding globulin (SHGB) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||nmol/l||Standard Deviation|Mean
1268085|NCT00375505|Secondary|Change in Testosterone From Baseline to Month 24|Change in Testosterone from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/ml||Standard Deviation|Mean
1268086|NCT00375505|Secondary|Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24|Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||mIU/ml||Standard Deviation|Mean
1268087|NCT00375505|Secondary|Change in Estradiol (E2) From Baseline to Month 24|Change in Estradiol from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/L||Standard Deviation|Mean
1268088|NCT00375505|Secondary|Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24|Change in Aminoterminal propeptide on type I procollagen (P1NP) from baseline to month 24. P1NP is a marker for bone formation. It is a specific indicator of type 1 collagen deposition. P1NP is increased in states of high bone turnover|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/ml||Standard Deviation|Mean
1268089|NCT00375505|Secondary|Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24|CTX is a telopeptide that can be used as a biomarker in the serum to measure the rate of bone turnover. The test used to detect the CTX marker is specific to bone resorption.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/mL||Standard Deviation|Mean
1268090|NCT00375505|Secondary|Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)|Bone mineral density (BMD) for Phalanges II, III, IV, and V is measured by ADSOS; ADSOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||m/s||Standard Deviation|Mean
1268091|NCT00375505|Secondary|Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)|Bone mineral density (BMD) for Os calcis (right and left side) is measured by BUA; BUA is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||dB/MHz||Standard Deviation|Mean
1268092|NCT00375505|Secondary|Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)|Bone mineral density (BMD) for Os calcis (right and left side) is measured by SOS; SOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||m/s||Standard Deviation|Mean
1268093|NCT00375505|Secondary|Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24|Bone mineral density (BMD) for total femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||percentage change||Standard Deviation|Mean
1268094|NCT00375505|Secondary|Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24|Bone mineral density (BMD) for femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||Percentage Change||Standard Deviation|Mean
1268095|NCT00375505|Primary|Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit|Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||percentage change||Standard Deviation|Mean
1268096|NCT00375505|Primary|Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score|Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||Z-score||Standard Deviation|Mean
1271725|NCT00346151|Secondary|Proportion of Participants With a Sirolimus Associated Adverse Event||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
1268097|NCT00375505|Primary|Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score|Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||T-score||Standard Deviation|Mean
1268098|NCT00375505|Primary|Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24|Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||Z-score||Standard Deviation|Mean
1268099|NCT00375492|Secondary|Rate of Hypoglycemic Events|Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).|24 weeks|Intent to Treat population|||events per patient per year||Standard Error|Least Squares Mean
1268100|NCT00375492|Secondary|Number of Participants With Hypoglycemic Events During the Study|Number of participants experiencing one or more events of hypoglycemia at any point in the study|Baseline to 24 weeks|Intent to Treat population|||participants|||Number
1268101|NCT00375492|Secondary|Ratio of Triglycerides at Week 24 to Triglycerides at Baseline|Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.|baseline, Week 24|Intent to Treat population|||Ratio||Standard Error|Geometric Mean
1268102|NCT00375492|Secondary|Change From Baseline in Total Cholesterol at Week 24|Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.|baseline, week 24|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
1268103|NCT00375492|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24|Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L|baseline, Week 24|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
1268104|NCT00375492|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24|Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.|baseline, Week 24|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
1268105|NCT00375492|Secondary|Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline|Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.|baseline, Week 24|Intent to Treat population|||Ratio||Standard Error|Geometric Mean
1268106|NCT00375492|Secondary|Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline|Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.|baseline, Week 24|Intent to Treat population|||Ratio||Standard Error|Geometric Mean
1268107|NCT00375492|Secondary|Change From Baseline in Waist Circumference at Week 24|Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).|baseline, Week 24|Intent to Treat population|||cm||Standard Error|Least Squares Mean
1268108|NCT00375492|Secondary|Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24|Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).|baseline, Week 24|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
1268109|NCT00375492|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.|baseline, Week 24|Intent to Treat population|||percent hemoglobin||Standard Error|Least Squares Mean
1268110|NCT00375492|Primary|Change From Baseline in Body Weight|Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).|Baseline, Week 24|Intent to Treat population|||kg||Standard Error|Least Squares Mean
1268111|NCT00375427|Secondary|Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score|ECOG Performance Score has 4 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. Outcome is given as median score for participants at Baseline and 3, 6 , 9 and 12 months of treatment|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.|||score on a scale||Full Range|Median
1271726|NCT00346151|Secondary|Proportion of Participants With Malignancies||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
1268112|NCT00375427|Secondary|Use Of Analgesic Medications According to the Analgesic Score Scale|"The analgesic score used for this study is modified from the Radiation Therapy Oncology Group (RTOG) analgesic score scale. The scale represents type of medication administered from 0 to 4 where:~0 = None~= Minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.)~= Tranquilisers, antidepressants, muscle relaxants, and steroids~= Mild narcotics (oxycodone, meperidine, codeine, etc.)~= Strong narcotics (morphine, hydromorphone, etc.) The outcome is given a the median score for the participants at Baseline and 3, 6, 9 and 12 months of treatment"|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.|||score on a scale||Full Range|Median
1268113|NCT00375427|Secondary|Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value|Pain intensity at rest and on movement is rated by the patient by means of a validated 6-point Verbal Rating Scale (VRS) and refers to the pain which occurred during the last week before the assessment. Median score value is the median of all the observed scores (none=0, very mild=1, mild=2, moderate=3, severe=5 and very severe=6) at each time point.|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.|||score on a scale||Full Range|Median
1268114|NCT00375427|Secondary|Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire|Bone pain was assessed by means of a pain score obtained using the Brief Pain Inventory (BPI) questionnaire. The BPI can produce three pain scores: worst pain, a composite pain score, and a pain interference score. The composite pain score, which is the average of questions 3, 4, 5 and 6 of the questionnaire was used in this study. Pain was rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). The outcome is given as the median score for participants at baseline, and 3, 6, 9 and 12 months of treatment|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients. All ITT patients with BPI questionnaire filled up at baseline were included.|||score on a scale||Standard Deviation|Mean
1268115|NCT00375427|Secondary|Percentage of Participants Skeletal Related Event (SRE) Free|"Percentage of participants SRE free is defined as the Kaplan-Meier estimate of participants free of any Skeletal Related Events(SRE) at each time point.~Skeletal Related Events (SREs) are:~pathologic bone fracture; non-vertebral and vertebral~spinal cord compression identified by X-rays~surgery to bone both curative and prophylactic~radiation therapy to bone (palliative, therapeutic or prophylactic)~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level which is symptomatic and requires treatment other than rehydration."|12 months|Intent-to-treat (ITT) population will include all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1268116|NCT00375427|Secondary|Median Time to First Skeletal Related Event(s) (SRE)|Median Time to first skeletal related event (SRE) is defined as the time from randomization to the date of first occurrence of any SRE which includes at least one of the following: radiation therapy to bone, pathologic bone fracture, spinal cord compression, surgery to bone, and hypercalcemia of malignancy (HCM). Due to the few numbers of SRE, Kaplan-Meier estimate never reaches a failure probability >=25%; so median time, 25th and 75th percentiles are not determined.For this reason only the estimated percentage of patient SRE free are reported at each time point.|12 month||||Day|||Number
1268117|NCT00375427|Secondary|Annual Incidence of Any Skeletal Related Events (SREs)|"Skeletal Related Events (SREs) are defined as a:~pathologic bone fracture such as non-vertebral and vertebral~spinal cord compression identified by X-rays evidence~surgery to bone both curative and prophylactic~radiation therapy to bone including palliative, therapeutic or prophylactic~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration. Annual incidence for each SRE was computed in the same way as annual overall SMR."|12 months|Intent-to-treat (ITT) population will include all randomized patients.|||Number of SRE per Year||Standard Deviation|Mean
1268118|NCT00375427|Secondary|Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)|"Skeletal Related Events (SREs) are defined as a:~pathologic bone fracture such as non-vertebral and vertebral compression fractures~spinal cord compression identified by positive diagnosis documented by X-ray evidence~surgery to bone both curative and prophylactic~radiation therapy to bone including palliative, therapeutic or prophylactic~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration."|12 month|Intent-to-treat (ITT) population will include all randomized patients.|||Percentage of Participants|||Number
1268119|NCT00375427|Primary|Annual Overall Skeletal Morbidity Rate (SMR)|"The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio “days of observation period / 365.25”, for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.~SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit."|12 months|Intent-to-treat (ITT) population will include all randomized patients.|||Number of Skeletal Events per Year||Standard Deviation|Mean
1268120|NCT00375219|Secondary|Kaplan-Meier Estimates for Overall Survival|Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.|up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
1268121|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Disease Progression|Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.|up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
1269222|NCT00366457|Secondary|Toxicity Profile|Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening|during and after first 28-day cycle of treatment|participants who started treatment|||Participants|||Count of Participants
1268122|NCT00375219|Secondary|Kaplan-Meier Estimates for Duration of Best Cytogenetic Response|Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to 4 years|Intent to treat population of participants who had a response|||months||Full Range|Median
1268123|NCT00375219|Secondary|Kaplan-Meier Estimates for Duration of Best Hematologic Response|Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to 4 years|Intent to treat population of participants who had a response|||months||Full Range|Median
1268124|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.~Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells."|up to 3 years|Intent to treat|||months||95% Confidence Interval|Median
1268125|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful."|Day 1 up to Month 6|Intent to treat|||months||95% Confidence Interval|Median
1268126|NCT00375219|Secondary|Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response||Day 1 up to 22 months|Intent to treat population of participants who had a cytogenetic response|||treatment cycles||Full Range|Median
1268127|NCT00375219|Secondary|Number of Treatment Cycles Needed to Achieve Best Hematologic Response|Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m^2 twice a day (BID) for the 14 consecutive days.|Day 1 up to Month 6|Intent to treat population of participants who had a response to treatment|||treatment cycles||Full Range|Median
1268128|NCT00375219|Secondary|Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL|Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).|Day 1 up to Month 9|Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL|||percentage of participants||95% Confidence Interval|Number
1268129|NCT00375219|Secondary|Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response|"Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).~Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~The percentage of participants achieving response with extramedullary disease at Baseline was to be summarized, if the sample size was sufficient. This analysis was not done as the sample was ultimately insufficient"|Day 1 up to Month 9|Intent to treat population of study participants who had extramedullary disease at baseline. Analysis not performed due to insufficient sample size.||||||
1268130|NCT00375219|Secondary|Percentage of Participants in Each Hematologic Response Category|"Complete Response (CHR)~Chronic phase must last at least 8 weeks: WBC <10*10^9/liter, platelets <450*10^9/liter, myelocytes + metamyelocytes <5% in blood, no blasts or promyelocytes in blood, <20% basophils in peripheral blood, no extramedullary involvement.~Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5*10^9/liter, platelets 100*10^9/liter, no blood blasts, bone marrow blasts <5%, no extramedullary disease.~Partial Response - CHR plus one or more of the following:~Persistence of splenomegaly with a reduction of ≥50% from pre-treatment~Platelets > 450*10^9/L~Presence of immature cells in the peripheral blood~5% to 25% blasts in the bone marrow~If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (<100*10^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as <5% bone marrow blasts."|Day 1 up to Month 6|Intent to treat|||percentage of participants|||Number
1268131|NCT00375219|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.|||percentage of participants||95% Confidence Interval|Number
1268132|NCT00375219|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.|||percentage of participants||95% Confidence Interval|Number
1268133|NCT00375219|Secondary|Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)|"Cytogenetic response categories:~Complete: 0% Ph+ cells~Partial: >0%-35% Ph+ cells~Minor: >35%-65% Ph+ cells~Minimal: >65%-95% Ph+ cells~No Response: >95% Ph+ cells~Unevaluable: <20 metaphases were examined and/or response could not be assigned"|Day 1 up to Month 9|Intent to treat|||percentage of participants|||Number
1268134|NCT00375219|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total|"TEAE are any untoward events that were newly occurring or worsening from Baseline.~Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug.~Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.~A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~A participant is only counted once in each category (at worst severity or strongest relationship)."|up to 3 years|Intent to treat|||participants|||Number
1268135|NCT00375219|Primary|Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.~Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1268136|NCT00375219|Primary|Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat population|||percentage of participants||95% Confidence Interval|Number
1268137|NCT00374907|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; unspec.=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|116 weeks|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period.|||participants|||Number
1268138|NCT00374907|Other Pre-specified|Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|116 weeks|Treated participants|||participants|||Number
1268139|NCT00374907|Secondary|Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12|Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.|Baseline, Week 12|Randomized Participants with both a baseline and post-baseline value (up to Week 12).|||Percent Change (Percentage of Baseline)||95% Confidence Interval|Geometric Mean
1268140|NCT00374907|Primary|Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12|Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.|Baseline, Week 12|Randomized participants with both a baseline and post-baseline value (up to Week 12).|||Percent Change (Percentage of Baseline)||95% Confidence Interval|Geometric Mean
1268141|NCT00374868|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 620 days)|20 patients were censored.|||days||Standard Error|Mean
1268142|NCT00374868|Secondary|Progression-Free Survival|Defined as the time from study enrollment until disease progression or death from any cause.|baseline to measured progressive disease (up to 620 days)|11 patients were censored|||days||95% Confidence Interval|Median
1271727|NCT00346151|Secondary|Proportion of Participants With Wound Complications||Start of study to end of study|Intent to Treat Sample|||Participants|||Number
1268143|NCT00374868|Secondary|Time to Treatment Failure (TTF)|Time from study enrollment to first observation of disease progression, death from any cause, or early discontinuation of treatment (including toxicity or if patient had stable disease after 4 cycles). TTF was censored at date of last follow-up visit for patients who did not discontinue early, who were still alive, and who had not progressed.|baseline to stopping treatment (up to 620 days)|1 patient was censored|||days||95% Confidence Interval|Median
1268144|NCT00374868|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions.|baseline to measured progressive disease (up to 620 days)|19 patients were censored|||days||Standard Error|Mean
1268145|NCT00374868|Secondary|Duration of Stable Disease|Defined as time from study enrollment to the first progression of disease, complete response, partial response, or death from any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.|time of no response or progression (up to 620 days)|1 patient was censored.|||days||95% Confidence Interval|Median
1268146|NCT00374868|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.|time of response to progressive disease (up to 620 days)|10 patients were censored.|||days||Standard Error|Mean
1268147|NCT00374868|Secondary|Time to Response|Defined as time from study enrollment to the first Complete Response or Partial Response (using RECIST criteria). Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.|baseline to response (up to 620 days)|16 patients were censored.|||days||Standard Error|Mean
1268148|NCT00374868|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 620 days)||||participants|||Number
1268149|NCT00374842|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.|From study start to study end, from Day 0 to Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1268150|NCT00374842|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.|Within the 30-day follow-up period (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1268151|NCT00374842|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.|Within the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1268152|NCT00374842|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.|Within the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1268153|NCT00374842|Primary|Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).|At Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1272336|NCT00336700|Primary|Recurrence Free Survival (RFS)|The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.|Up to 60 months||||months||95% Confidence Interval|Median
1268154|NCT00374842|Primary|Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.|At Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subject|||Number
1268155|NCT00374842|Primary|Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.|A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).|At Day 0 and at Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subject|||Number
1268156|NCT00374842|Primary|Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.|At Day 0 and at Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||HIU||95% Confidence Interval|Geometric Mean
1268157|NCT00374803|Secondary|GI Toxicities|Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)|12 months||||participants|||Number
1268158|NCT00374803|Secondary|Incidence of Post Transplant Infections|Incidence of post transplant infections that resulted in hospitalization|12 months||||participants|||Number
1268159|NCT00374803|Secondary|Renal Function at 12 Months|Renal function measured by serum creatinine (SCr) at 12 months post-transplant|12 months||||mg/dL||Standard Deviation|Mean
1268160|NCT00374803|Secondary|Patient and Allograft Survival 12 Months|Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.|12 months||||participants|||Number
1268161|NCT00374803|Primary|Incidence of All Biopsy Proven Acute Rejection.|Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine|12 months||||Participants|||Number
1268162|NCT00374556|Secondary|Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale|The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Joint Stiffness was assessed on a VAS scale of 0-20, with 0 being no joint stiffness, and 20 being maximum stiffness.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
1268163|NCT00374556|Secondary|Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary|The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Mental Component Summary was used here as a global index of mental health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
1268164|NCT00374556|Secondary|Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary|The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Physical Component Summary was used here as a global index of physical health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
1268165|NCT00374556|Secondary|Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale|The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Disability was assessed on a VAS of 0-100, with 0 being absolutely no disability and 100 being maximum disability.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
1269382|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)|||percentage of labeled cells||Standard Deviation|Mean
1268166|NCT00374556|Secondary|Pressure Pain Threshold|A Somedic algometer was used to assess pressure pain threshold (PPTh) similar to previous studies. The algometer’s 1cm2 rubber probe was placed over the muscle belly, with the pressure increased steadily at a constant rate (30kPA/Sec), until the subject indicated that s/he “first felt pain.” PPTh was assessed 2 times each, bilaterally, at (in a randomized order) the masseter muscle trapezius muscle, and at the proximal third of the brachioradialis muscle (forearm). The scores from each location were averaged for each participant at that respective time point. The same site was never stimulated consecutively. At least 90 s were maintained between successive stimuli|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||kPA||Standard Deviation|Mean
1268167|NCT00374556|Secondary|Heat Pain Tolerance (HPTOL)|Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitization. HPTOL was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of HPTOL were conducted. An average of both trials at each respective time point is presented below. Subjects push a button when the stimulus “becomes intolerable.” The temperature (degrees Celsius) at the time button is pushed to terminate the stimulation is automatically recorded.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||degrees Celsius||Standard Deviation|Mean
1268168|NCT00374556|Secondary|Heat Pain Threshold|Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitizationHPTh was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of heat pain threshold were conducted. Averages of both trials are presented from respective time point below. Subjects push a button when the stimulus “first feels painful” The temperature (degrees Celsius) at the time button is pushed is automatically recorded.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||degrees Celsius||Standard Deviation|Mean
1268169|NCT00374556|Primary|Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale|The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Pain was assessed on a scale of 0-100, with 0 being absolutely no pain and 100 being maximum pain.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
1268170|NCT00374556|Primary|Mean Level of Pain Experienced Throughout the Day|Assessed using a Daily Pain Diary with a scale 0-100, 0 being no pain, 100 being the most severe/intense|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
1268171|NCT00374556|Primary|Temporal Summation (TS)|TS :maximum windup pain rating - first windup pain rating (0-100). Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to left forearm. In order to assess temporal summation, three sequences of 10 heat pulses each (with stimulus temperatures of 46 degrees C, 48 degrees C, and 50 degrees C, in random order) were applied to left dorsal forearm. The thermode remains in fixed position during administration of 10 heat pulses that constitute a sequence. Within each sequence, successive thermal pulses at a given temperature are delivered for a duration of approximately 0.5 sec each, with a 2.5-sec inter-pulse interval. The rate of rise & fall of the thermode temp. is set at the device max .of 10 degrees C / S. Subjects verbally rate the perceived intensity of each thermal pulse on a 0-100 rating scale & may terminate the procedure at any time.100=max tolerable intensity|Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
1268172|NCT00374556|Primary|Diffuse Noxious Inhibitory Control (DNIC) Index Scores|PPTh:a somedic algometer’s 1cm2 rubber probe was placed over muscle belly, with pressure increasing steadily at constant rate (30kPA/Sec), until subject indicated that s/he “first felt pain.” PPTh ratings were obtained on right brachioradialis & right trapezius in a random order (average was taken from both areas at each time point). During each cold pressor task, participants immersed contralateral hand (left) up to wrist, in a circulating cold water bath maintained at 4°C. 20 seconds after commencing hand immersion, PPTh was re-assessed on either right brachioradialis or right trapezius (the same site as baseline assessment). After PPTh assessment, participants removed hands from water. DNIC was measured as the % change in PPTh during cold pressor, relative to baseline PPTh [i.e., (mean PPTh during cold pressor / mean PPTh prior to cold pressor)*100]. Increase in PPTh during cold pressor (i.e., percentage scores above 100) reflects normal functioning of pain-inhibitory processes.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||percentage change of PPTh||Standard Deviation|Mean
1268173|NCT00374556|Primary|Insomnia Severity Index (ISI) Mean Total Scores|The ISI is made up of 7 questions, each possible of earning a score of 0-4, making the total range 0-28, where 0 indicates no severity/no problem with sleep and therefore no insomnia, or 28, being very severe with the highest level of insomnia|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task.|||units on a scale||Standard Deviation|Mean
1268772|NCT00370331|Secondary|Percentage of Participants Initiating Rescue Treatment On-therapy|Percentage of participants initiating new ITP medication, an increased dose of concomitant ITP medication from baseline, platelet transfusion, or splenectomy.|Anytime from Day 1 to Week 26|All participants randomized to receive placebo or eltrombopag treatment|||Percentage of participants|||Number
1268174|NCT00374556|Primary|Sleep Latency as Assessed by Actigraphy|Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep latency is the time taken to fall asleep, or equal to lights out- sleep onset (sleep onset: time when sleep is first scored after lights out, first scorable epoch).|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
1268175|NCT00374556|Primary|Sleep Efficiency as Assessed by Actigraphy|Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep efficiency is the index of sleep percentage recorded, equal to total sleep time divided by the time in bed X 100 = X%.|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||percentage of time asleep||Standard Deviation|Mean
1268176|NCT00374556|Primary|TST as Assessed by Actigraphy|Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. TST recorded by device = total minutes spent asleep|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
1268177|NCT00374556|Primary|WASO as Assessed by Actigraphy|Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. WASO recorded by device = total minutes of wakefulness after sleep onset, in minutes.|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
1268178|NCT00374556|Primary|Sleep Quality (SQ)|As recorded in daily sleep diary. Visual analog scales (VAS) Sleep Quality Ratings 0-100, 0= extremely poor sleep quality, (shallow and unrefreshing) and 100=excellent sleep quality (deep and refreshing)|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
1268179|NCT00374556|Primary|Sleep Efficiency (SE)|[(TST/ TIB)X 100], (%) as recorded in daily sleep diary|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||percentage of efficient sleep||Standard Deviation|Mean
1268180|NCT00374556|Primary|Total Sleep Time (TST)|minutes spent asleep as recorded in daily sleep diary|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
1268181|NCT00374556|Primary|Number of Awakenings|As recorded in daily sleep diary|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||number of awakenings||Standard Deviation|Mean
1268182|NCT00374556|Primary|Sleep Latency (SL)|Sleep Latency: time taken to fall asleep, in minutes (as recorded in daily sleep diary)|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
1268183|NCT00374556|Primary|Time in Bed|Total time in bed, in minutes|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
1268184|NCT00374556|Primary|Wake After Sleep Onset (WASO)|Total minutes of wakefulness recorded after sleep onset. (Recorded in Daily Sleep Diary) WASO= time awake in the middle of the night, not counting SL or time in bed after awakening. Recorded in minutes|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
1268185|NCT00374543|Primary|Hamilton Anxiety Rating Scale (HAM-A)|"The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.~Due to study termination, there are not results for primary and secondary outcome measures."|8 weeks|Zero participants were analyzed because recruitment was very low. Due to this, we felt any analysis done would not be usable for accurate analyses.||||||
1268186|NCT00374543|Secondary|Clinical Global Impression of Improvement (CGI-I)|"A secondary categorical outcome of response will be defined as a Clinical Global Impression Improvement Score (CGI-I) of 1 or 2. The CGI-I is a 7 point clinician-rated scale that assesses symptom improvement or worsening relative to a previous assessment. Lower ratings reflect greater improvement.~Due to study termination, there are not results for primary and secondary outcome measures."|8 weeks|||||||
1268202|NCT00374322|Secondary|Time to Central Nervous System (CNS) Recurrence|Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table.|From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])|||||||
1268187|NCT00374452|Primary|Mean Percentages of Events After Index Visit to Primary Care by Patient|The outcome measure was mean percentages of Events after index visit to primary care by patients. The Events were the first event in the patient record after the index clinic visit for the patient, as follows. Event 1 is intensification of pharmacotherapy for hypertension. Event 2 is patient achieves below-target blood pressure (BP). Event 3 is patient does not achieve below-target BP nor is there intensification of pharmacotherapy for hypertension. Event 4 is patient does not achieve BP target, does not have intensified pharmacotherapy, and does not return for further BP measurements. Each patient was assigned one and only one Event. If a patient has pharmacotherapy intensified and also achieved BP below-target, the patient was assigned to whichever happened first. An initial model fitting all 4 events did not detect a difference by study arm for mean percentage of Event 4; final findings are based on a denominator of Events 1 - 3.|up to one year after index visit||||mean percentage of events|clinic sites||Number
1268188|NCT00374335|Primary|Presence of Hepatic Hemangiomas on Abdominal Ultrasound|The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound|2 years|||||||
1268189|NCT00374335|Secondary|Risk Factors Associated With the Development of Hepatic Hemangiomas|Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound|2 years||||participants|||Number
1268190|NCT00374335|Primary|Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound|The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound|2 years||||participants|||Number
1268191|NCT00374322|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings|12-lead ECG measurements were taken at Screening and at study conclusion/withdrawal. The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as classified by the investigator, were summarized. Participants with missing values were categorized as missing. Data for the primary analysis (conducted in 2011) are reported.|Screening and Month 12/Early Withdrawal Visit|SP. Only those participants (par.) available at the specified time points were analyzed. Two par. were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.|||Participants|||Number
1268192|NCT00374322|Secondary|Number of Participants Experiencing Primary or Secondary Cardiac Events|A cardiac event is classified as a primary cardiac endpoint (PCE) or a secondary cardiac endpoint (SCE). PCE is defined as: cardiac death (cardiac death due to heart failure, myocardial infarction, or arrhythmia;or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event); severe symptomatic congestive heart failure (CHF) (as per New York Heart Association [NYHA] Class III or IV and an absolute decrease in left ventricular ejection fraction [LVEF] of more than 10 percentage points from Baseline and to a left ventricular ejection fraction [LVEF] value below 50%). SCE is defined as asymptomatic or mildly symptomatic cardiac events (NYHA Class I or II) and a significant decrease in LVEF, defined as an absolute decrease in LVEF of more than 10 percentage points from Baseline and to an LVEF value below 50%.|From the date of randomization up to 12 months|Safety Population (SP). Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.|||Participants|||Number
1268193|NCT00374322|Secondary|Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades|"Non-laboratory toxicities are defined as adverse events (AEs). The number of partcipants with any treatment-emergent AE of the indicated toxicity grade are summarized. Toxicity grading was according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 as follows: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life threatening; Grade 5=death. The events that were not given a toxicity grade are categorized as Not Applicable."|From the first dose of study treatment up to 12 months|Safety Population. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.|||Participants|||Number
1268194|NCT00374322|Secondary|Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters|"The clinical chemistry parameters assessed were: alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), aspartate amino transferase (AST), bicarbonate, blood urea nitrogen (BUN), bone alkaline phosphatase (Bone ALP), calcium, chloride, creatinine, creatinine clearance (Cr. Clearance), creatinine clearance estimated (Cr. Clrnc. est.), glucose, potassium, sodium, total bilirubin (Total Bln), total protein, urea, and uric acid. The Baseline (BL) value is the last available pre-treatment result recorded. Any post-Baseline value was based on results recorded at scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) was presented for BL and any post-Baseline (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm."|At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit|Safety Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1268200|NCT00374322|Secondary|Modified Disease-free Survival (MDFS)|Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table.|From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)|||||||
1268195|NCT00374322|Secondary|Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters|"The hematology parameters assessed were: basophils (Bs) in giga (10^9) per liter (GI/L) and in percentage (%), eosinophils (Eo) in GI/L and %, hematocrit, hemoglobin, lymphocytes (Lmph) in GI/L and %, monocytes (Mono) in GI/L and %, platelet count, Red Blood Cell (RBC) count, total neutrophil count (TNC) in GI/L and %, and White Blood Cell (WBC) count. The Baseline (BL) value is the last available pre-treatment result recorded. Any post-Baseline value was based on results recorded at any scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) is presented for BL and any post-Baseline (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported."|At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit|Safety Population (SP): all randomized participants (par.) who received >=1 dose of randomized treatment. Only those par. available (n=X, X in the category titles) at the specified time points were analyzed. Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.|||Participants|||Number
1268196|NCT00374322|Secondary|Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) perceptions, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain is scored from 0 (poorer health) to 100 (better health); higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1268197|NCT00374322|Secondary|Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1268198|NCT00374322|Secondary|Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1268199|NCT00374322|Secondary|Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])|DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.|From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)|ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.|||Participants|||Number
1268201|NCT00374322|Secondary|Number of Participants With CNS Recurrence|The number of participants experiencing a CNS recurrence was summarized.|From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])|ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.|||Participants|||Number
1268773|NCT00370331|Secondary|Summary of Median Platelet Counts|Platelet counts were measured by blood draw.|Baseline; Day 8 through Week 26 on-treatment; and 1, 2, 4 week follow-up visits|ITT Population|||platelets/microliter (ul)||Full Range|Median
1268203|NCT00374322|Secondary|Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)|Distant recurrence (metastatic disease) is defined as a tumor in any area of the body not including those defined as local or regional recurrence. Sites of distant recurrence include: skin, subcutaneous tissue, and lymph nodes (excluding those described for local and regional recurrence); bone marrow; skeletal; lungs and pleural; ascites and pleural effusions; liver and other viscera; and central nervous system (CNS). Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a distant recurrence.|From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.|||Percentage of participants|||Number
1268204|NCT00374322|Secondary|Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)|Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS).|From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.|||Percentage of participants|||Number
1268205|NCT00374322|Secondary|Number of Participants Who Died (Overall Survival)|Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive.|From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.|||Participants|||Number
1268206|NCT00374322|Primary|Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])|DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.|From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of randomized treatment (lapatinib or placebo). Data for the end-of-study analysis (conducted in 2013) are reported.|||Participants|||Number
1268207|NCT00374244|Secondary|Trail Making Test: Trail B|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Endpoint (12 weeks)|Intent to Treat Analysis|||seconds||Standard Deviation|Mean
1268208|NCT00374244|Secondary|Trail Making Test: Trail B|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Baseline|Intent to Treat Analysis|||seconds||Standard Deviation|Mean
1268209|NCT00374244|Secondary|Trail Making Test: Trail A|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Endpoint (12 weeks)|Intent to Treat Analysis|||seconds||Standard Deviation|Mean
1268799|NCT00369967|Primary|Method Continuation at 12 Months|Participants reporting continuation with method at 12 months|12 months|Participants enrolled|||participants|||Number
1268210|NCT00374244|Secondary|Trail Making Test: Trail A|Working memory by Digit Span and Letter Number Sequencing, and attention/executive functions were measured by the Trail Making Test (Parts A and B). This is an assessment of attention/executive function, it does not have an interpret-able range of scores like a traditional scale. Subjects makes trails on paper against time.|Baseline|Intent to Treat Analysis|||seconds||Standard Deviation|Mean
1268211|NCT00374244|Secondary|Verbal Learning and Memory: List B|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List B: Single Trial. This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Endpoint (12 weeks)|Intent to Treat Analysis|||words||Standard Deviation|Mean
1268212|NCT00374244|Secondary|Verbal Learning and Memory: List B|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List B: Single Trial. This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Baseline|Intent to Treat Analysis|||words||Standard Deviation|Mean
1268213|NCT00374244|Secondary|Verbal Learning and Memory: List A|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List A: Total Trials (1-5). This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Endpoint (12 weeks)|Intent to Treat Analysis|||words||Standard Deviation|Mean
1268214|NCT00374244|Secondary|Verbal Learning and Memory: List A|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List A: Total Trials (1-5). This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Baseline|Intent to Treat Analysis|||words||Standard Deviation|Mean
1268215|NCT00374244|Secondary|Processing Speed|Processing speed was assessed using using Digit Symbol Coding from the Wechsler Adult Intelligence Scale, Revised (WAIS-R). The tool is used for the assessment of processing speed. The range of scores is 0 to 100- with the higher number indicating greater performance.|Endpoint (12 weeks)|Intent to Treat Analysis|||units on a scale||Standard Deviation|Mean
1268216|NCT00374244|Secondary|Processing Speed|Processing speed was assessed using using Digit Symbol Coding from the Wechsler Adult Intelligence Scale, Revised (WAIS-R). The tool is used for the assessment of processing speed. The range of scores is 0 to 100- with the higher number indicating greater performance.|Baseline|Intent to Treat Analysis|||units on a scale||Standard Deviation|Mean
1268217|NCT00374244|Secondary|QTc|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms.|Endpoint (12 weeks)|Intention to Treat|||ms||Standard Deviation|Mean
1268218|NCT00374244|Secondary|QTc|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms.|Baseline|Intention to Treat|||ms||Standard Deviation|Mean
1268219|NCT00374244|Secondary|Verbal Fluency|Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance.|Endpoint (12 weeks)|Intent to Treat Analysis|||words||Standard Deviation|Mean
1268220|NCT00374244|Secondary|Verbal Fluency|Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance.|Baseline|Intent to Treat Analysis|||words||Standard Deviation|Mean
1268221|NCT00374244|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0‐5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.|Endpoint (12 weeks)|Analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
1268222|NCT00374244|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0‐5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.|baseline|Analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
1268223|NCT00374244|Secondary|CGI Improvement Scale (CGI‐I)|"CGI Improvement Scale (CGI‐I) higher rating correlates with worsening of condition (vs. improvement with lower rating). The CGI-I is scored from 1 to 7 where 1 = 'very much improved' and 7 = 'very much worse'. Clinicians are asked to rate total improvement in the following manner: ...in your judgement, it is due entirely to drug treatment. Compared to his condition at admission to the project, how much has he changed?"|Endpoint (12 weeks)|Analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
1268224|NCT00374244|Secondary|CGI Severity of Illness Scale (CGI‐S)|CGI Severity of Illness Scale (CGI‐S) assesses severity of illness on 1‐7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill.|Endpoint (12 weeks)|Analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
1268225|NCT00374244|Secondary|CGI Severity of Illness Scale (CGI‐S)|CGI Severity of Illness Scale (CGI‐S) assesses severity of illness on 1‐7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill.|baseline|Analyzes intent to treat.|||units on a scale||Standard Error|Least Squares Mean
1268226|NCT00374244|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|The Brief Psychiatric Rating Scale (BPRS) is an 18‐item instrument. The items are anchored on a 7‐point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.|Endpoint (12 weeks)|Subjects were analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
1268227|NCT00374244|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|The Brief Psychiatric Rating Scale (BPRS) is an 18‐item instrument. The items are anchored on a 7‐point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.|Baseline|Subjects were analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
1268228|NCT00374231|Other Pre-specified|Time Post Transplant Corticosteroid Withdrawal|The mean days from post transplant corticosteroid withdrawal.|12 months||||days||Standard Deviation|Mean
1268229|NCT00374231|Secondary|Patient Survival.||12 months||||participants|||Number
1268230|NCT00374231|Primary|Incidence of Biopsy Confirmed Acute Rejection at 12 Months.||12 months||||participants|||Number
1268231|NCT00374140|Secondary|Objective Response Rate|Number of patients for which response to treatment was observed / total number of patients.|From beginning of treatment up to 60 months|Evaluable for response included patient had completed at least one cycle of therapy with everolimus.|||percentage of participants||95% Confidence Interval|Number
1268232|NCT00374140|Secondary|Progression-free Survival||From entry into trial to up to 60 months||||months||95% Confidence Interval|Median
1268233|NCT00374140|Secondary|Overall Survival||From entry in trial to up to 60 months||||months||95% Confidence Interval|Median
1268234|NCT00374140|Primary|Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.||Two cycles of treatment with RAD001 (~6 weeks)||||percentage of participants||95% Confidence Interval|Number
1268235|NCT00374127|Secondary|Heart Rate|Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.|180 minutes|Twenty-four participants were included in this analysis.|||BPM||Standard Deviation|Mean
1268236|NCT00374127|Secondary|Carbon Monoxide|Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants.|180 minutes|Twenty-four participants were included in this analysis.|||ppm||Standard Deviation|Mean
1268237|NCT00374127|Secondary|Subjective Effects on VAS|Subjective VAS ratings of ‘Good Drug Effect’ and ‘High’ averaged across all post-smoking time points when marijuana was smoked as joints and blunts analyzed for all participants. Here, participants indicated how they were feeling on a 100-mm line anchored with ‘not at all’ at the left end and ‘extremely’ at the right end, when prompted by a statement|180 minutes|Twenty-four participants were included in this analysis.|||Ratings (mm)||Standard Deviation|Mean
1268238|NCT00374127|Secondary|Subjective Effects on MRF|"Using the Marijuana Rating Form (MRF), subjective effects of Take Again, Liking, and Strong were assessed. The MRF is a visual analog scale allowing patients to indicate how they feel on a 100-mm line anchored with ‘not at all’ at the left end and ‘extremely’ at the right end, when prompted by a statement."|180 minutes|Twenty four participants were included in this within-subjects analysis.|||Ratings (mm)||Standard Deviation|Mean
1268239|NCT00374127|Primary|Plasma THC|Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.|180 minutes|Twenty four participants were included in this within-subjects analysis.|||ng/mL||Standard Deviation|Mean
1268240|NCT00374088|Post-Hoc|Urine Output|Total urine output over the first 24 hours postoperative|24 hours||||mL||Standard Deviation|Mean
1268241|NCT00374088|Post-Hoc|Max Creatinine|Maximum serum creatinine over first 3 days postoperative.|72 hours||||mg/dL||Standard Deviation|Mean
1268242|NCT00374088|Primary|Maximum Decline in Measured Cardiac Output|Serial cardiac output was measured by thermodilution. The outcome of maximum decline in indexed cardiac output from 1 hour postoperative to lowest output within 24 hours postoperative was then calculated and compared between NAC and placebo groups.|24 hours|Patients in which the surgeon was technically able to place a 4 French thermodilution catheter into the pulmonary artery at the time of surgery had cardiac output measured.|||L/min/m2||Standard Deviation|Mean
1268243|NCT00373958|Secondary|Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose|Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the infant series and the toddler dose|Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
1268244|NCT00373958|Secondary|Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series and one month after toddler dose|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate postinfant series OPA antibody titer to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1268245|NCT00373958|Primary|Percentage of Participants Reporting Pre-specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate ([Mod.], 2.5 to 7.0 cm); Severe ([Sev.], > 7.0 cm). Participants may have been represented in more than 1 category.|Within 7 days after each dose|Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.|||Percentage of participants|||Number
1268246|NCT00373958|Primary|Percentage of Participants Reporting Pre-specified Systemic Events|Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after each dose|Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.|||Percentage of participants|||Number
1268247|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
1268248|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|"Normalization was performed for unit of measure index value as Index Value of 1.00 = 10 mIU/mL."|one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.|||index value||95% Confidence Interval|Geometric Mean
1268249|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.|||µg/mL||95% Confidence Interval|Geometric Mean
1268250|NCT00373958|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)||One month after toddler dose (13 to 16 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.(n)=number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.|||percentage of participants||95% Confidence Interval|Number
1268251|NCT00373958|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).|One Month After the Infant Series (7 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.|||Percentage of participants||95% Confidence Interval|Number
1268252|NCT00373958|Primary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 Month After the Toddler Dose|Evaluable immunogenicity (per protocol) population of eligible participants, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1268253|NCT00373958|Primary|Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the 3-dose infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1268254|NCT00373880|Secondary|Plasma Cocaine|Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose.|8 minutes|Eight participants were included in this within-subjects analysis.|||ng/mL||Standard Deviation|Mean
1268274|NCT00373685|Secondary|Percentage of Participants With Moderate to Severe Abdominal Symptoms|"Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to “Gastrointestinal Signs and Symptoms; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants’ usual function and severe indicated the GI AE interfered significantly with participants’ usual function."|Baseline through week 24 or ET|ITT;|||Percentage of participants|||Number
1268800|NCT00369967|Primary|Method Continuation at 6 Months|Participants reporting continuation of method at 6 months|6 months|Participants enrolled|||participants|||Number
1268255|NCT00373880|Secondary|Subjective Effects of Cocaine|"Mean Visual Analog Scale (VAS) ratings (items: Quality, Pay for Dose, Good Drug Effect, and Cocaine Craving) from 0-100mm as a function of cocaine dose and aripiprazole dose 4 min following a single administration of cocaine (the “sample dose”) at the start of the session.~For Quality item, the perceived quality of the drug is rated. The higher the rating, the better quality the drug was perceived to be.~For Pay for Dose item, the likelihood that the participant would pay for the drug is indicated. Higher ratings indicate a better likelihood that the person would pay for the dose received.~For Good Drug Effect, the likelihood of feeling a good drug effect is indicated. The higher the number, the more of a good drug effect the person reported.~For Cocaine Craving, the intensity of craving is reported. Higher scores indicate more craving for cocaine."|5 days|Eight participants were included in this within-subjects analysis.|||Scores on a scale of 0-100mm||Standard Error|Mean
1268256|NCT00373880|Primary|Cocaine Self-administration|"Mean number of cocaine choices as a function of cocaine dose and aripiprazole dose (n=8).~Participants sampled the dose of cocaine available for the session and then had five choices to respond for money ($5.00) or cocaine using a modified progressive-ratio schedule."|5 days|Eight participants were included in this within-subjects analysis.|||Number of Choices||Standard Error|Mean
1268257|NCT00373698|Secondary|SF-36 Physical Component||3 and 6 months after initial assessment||||units on a scale||Standard Deviation|Mean
1268258|NCT00373698|Secondary|SF-36 Mental Component||3 and 6 months after initial assessment||||units on a scale||Standard Deviation|Mean
1268259|NCT00373698|Secondary|Depression|Measure using the Hopkins Symptom Checklist-20|3 and 6 months after initial assessment||||units on a scale||Standard Deviation|Mean
1268260|NCT00373698|Primary|PTSD Symptom Severity|PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)|3 and 6 months after initial assessment||||units on a scale||Standard Deviation|Mean
1268261|NCT00373685|Other Pre-specified|Percentage of Participants With Non-study Medication Utilization|Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use.|Baseline through week 24 or ET|ITT; N= number of evaluable participants analyzed|||Percentage of participants|||Number
1268262|NCT00373685|Other Pre-specified|Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization|PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists [H2RA], misoprostol, sucralfate, and others such as antacids) utilization.|Baseline through week 24 or ET|ITT; any randomized participant who received at least one dose of study medication; N= number of evaluable participants analyzed|||Percentage of participants|||Number
1268263|NCT00373685|Other Pre-specified|Percentage of Participants With Positive Blood Fecal Occult|Positive blood fecal occult; blood in feces that is not visibly apparent|Week 24 or ET|ITT|||Percentage of participants|||Number
1268264|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF|||Percentage of participants|||Number
1268265|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF|||Percentage of participants|||Number
1268266|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF|||Percentage of participants|||Number
1268267|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall|Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at specific time point; LOCF|||Percentage of participants|||Number
1268268|NCT00373685|Secondary|Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline|Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL).|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at the specific time point; LOCF|||Percentage of participants|||Number
1268269|NCT00373685|Secondary|Change From Baseline Hct at Week 24||Week 24 or ET|ITT; N= number of evaluable participants analyzed; LOCF|||Percent||Standard Error|Least Squares Mean
1268270|NCT00373685|Secondary|Hematocrit (Hct) at Baseline||Baseline|ITT; N= number of evaluable participants analyzed|||Percent||Standard Deviation|Mean
1268271|NCT00373685|Secondary|Change From Baseline Hb at Week 24||Baseline and Week 24 or ET|ITT; N=number of evaluable participants analyzed; Last observation carried forward (LOCF)|||g/dL||Standard Error|Least Squares Mean
1268272|NCT00373685|Secondary|Hemoglobin (Hb) at Baseline||Baseline|ITT; N= number of evaluable participants analyzed|||gram per deciliter (g/dL)||Standard Deviation|Mean
1268273|NCT00373685|Secondary|Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)|GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions|Baseline through week 24 or ET|ITT|||Percentage of participants|||Number
1268801|NCT00369967|Primary|Continuation With the Contraceptive Method|Participants reporting continuation with contraceptive method at 3 months|3 months|Number using method at 3 months|||participants|||Number
1268275|NCT00373685|Primary|Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)|CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.|Baseline through week 24 or Early Termination (ET)|Intent-to-Treat (ITT) Population: randomized participants|||Percentage of participants|||Number
1268276|NCT00373529|Other Pre-specified|Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors|The number of participants within each subgroup of baseline prognostic factors of the full analysis set who achieved a best response of either a complete response (CR) or a complete response in the absence of platelet recovery (CRp) as determined by the Independent Response Review Panel following a maximum of two cycles of treatment.|approximately Month 2|Full analysis set (FAS) of participants who achieved remission and had baseline prognostic factor|||participants|||Number
1268277|NCT00373529|Secondary|Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)|Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.|up to Day 30|Full analysis set|||percentage of participants|||Number
1268278|NCT00373529|Secondary|Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods|"Participants with AEs that occurred during the treatment and follow-up periods. AEs were classified according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. Treatment emergent is defined as any event that either first presents after baseline or worsens in severity after baseline.~NCI Common Terminology Criteria for Severity:~Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Death related to AE"|Up to 2 years|Full analysis set|||participants|||Number
1268279|NCT00373529|Secondary|Kaplan Meier Estimates for Overall Survival (OS)|OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.|Up to 2 years|Full analysis set|||weeks||95% Confidence Interval|Median
1268280|NCT00373529|Secondary|Kaplan Meier Estimate for Disease-free Survival (DFS)|DFS was defined as the number of days from achievement of IRRP-determined overall response until IRRP-determined disease recurrence or death (any cause), regardless of intervening alternative antileukemic treatment, plus 1 day.|Up to 2 years|Full analysis set (FAS) of participants who achieved remission.|||weeks||95% Confidence Interval|Median
1268281|NCT00373529|Secondary|Kaplan Meier Estimate for Duration of Remission (DOR)|DOR was defined as the number of days from achievement of OR as assessed by the Independent Response Review Panel (IRRP) until IRRP-determined disease recurrence or death (any cause), plus 1 day. Participants who initiated alternative antileukemic treatment while in remission were censored on the date the therapy was initiated or on the date of last follow-up.|Up to 2 years|Full analysis set (FAS) of participants who achieved remission.|||weeks||95% Confidence Interval|Median
1268282|NCT00373529|Primary|Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)|Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.|approximately Month 2|Full analysis set (FAS)|||percentage of participants|||Number
1268283|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 21 (400 mg)||Day 21 (400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.|||μM||Standard Deviation|Geometric Mean
1268284|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 3 (600 mg)||Day 3 (600 mg)||||μM||Standard Deviation|Geometric Mean
1268285|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)||Day 1 (600 mg and 400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.|||μM||Standard Deviation|Geometric Mean
1268286|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞)|Day 21 (400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.|||μM·hr||Standard Deviation|Geometric Mean
1268287|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞)|Day 3 (600 mg)||||μM·hr||Standard Deviation|Geometric Mean
1268288|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours.|Day 1 (600 mg and 400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.|||μM·hr||Standard Deviation|Geometric Mean
1268289|NCT00373490|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment|21 Days (first cycle)|Six (6) participants received vorinostat at 400 mg once daily. Of these, 2 participants did not complete the first cycle resulting in the drug compliance falling below 75%, and thus these participants were excluded from the DLT assessment.|||Participants|||Number
1269289|NCT00365859|Primary|Mean Change From Baseline in Patient Weight||At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)|||kg||Standard Deviation|Mean
1268290|NCT00373425|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.~An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.~A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug."|From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.|Randomized Cohort, safety analysis set: all randomized participants who received at least one dose of study drug. One participant in the Randomized Cohort assigned to the erlotinib arm received placebo instead due to a dispensing error and is included in the placebo group for safety analyses.|||participants|||Number
1268291|NCT00373425|Secondary|Overall Survival in Participants With EGFR Mutation - Positive Tumors|"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.~Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected."|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)|Randomized cohort full analysis participants who were EGFR mutation positive|||months||95% Confidence Interval|Median
1268292|NCT00373425|Secondary|Overall Survival in Participants With EGFR Mutation - Positive Tumors|"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.~Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected."|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)|Randomized cohort full analysis participants who were EGFR mutation positive|||months||95% Confidence Interval|Median
1268293|NCT00373425|Primary|Disease Free Survival (DFS)|DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set (all randomized participants).|||months||95% Confidence Interval|Median
1268294|NCT00373425|Secondary|Disease-free Survival in Participants With EGFR Mutation - Positive Tumors|Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set participants who are EGFR mutation positive|||months||95% Confidence Interval|Median
1268295|NCT00373425|Secondary|Disease-free Survival in Participants With EGFR Mutation - Positive Tumors|Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set participants who are EGFR mutation positive|||months||95% Confidence Interval|Median
1268296|NCT00373425|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set|||months||95% Confidence Interval|Median
1268297|NCT00373425|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set|||months||95% Confidence Interval|Median
1268298|NCT00373425|Primary|Disease Free Survival (DFS)|DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set (all randomized participants).|||months||95% Confidence Interval|Median
1269302|NCT00365846|Secondary|Patient Survival||3 years||||participants|||Number
1268299|NCT00373399|Primary|Change From Baseline in Iowa Gambling Task Scores [Objective Measure of Decision Making]|"A modified version of the Gambling Task (Bechara et al., 1994) was used. Four decks of cards (A–D) were displayed on a computer screen. Volunteers were told that the objective of the game was to win as much money as possible. They were also told that the game entailed a series of card selections from any of the decks, one card at a time, and that they should select cards until instructed to stop. The task was stopped after 100 card selections or after 5 min had elapsed. Data indicate change from baseline in mean number of cards selected from advantageous decks minus number of cards selected from disadvantageous decks as a function of drug condition. Higher numbers indicate better decision making regarding advantageous cards.~Planned comparisons using single degrees of freedom, generated by a two-tailed repeated measures analysis of variance (ANOVA), were used to examine the effects of THC concentration (0% vs. 1.8%, 0% vs. 3.9%, and 1.8% vs. 3.9%) on task performance."|3 weeks|All participants who completed the study (N=36) were included in the final analysis.|||mean number of cards||Standard Deviation|Mean
1268300|NCT00373386|Secondary|HDL|Plasma HDL|3 months||||mg/dl||Standard Error|Mean
1268301|NCT00373386|Secondary|LDL|LDL level|3 months||||mg/dl||Standard Error|Mean
1268302|NCT00373386|Secondary|Triglycerides|Plasma Triglycerides|3 months||||mg/dl||Standard Error|Mean
1268303|NCT00373386|Secondary|HOMA|Insulin resistance|3 months||||mg uU/dl ml||Standard Error|Mean
1268304|NCT00373386|Secondary|Insulin|Plasma insulin|3 months||||uU/ml||Standard Error|Mean
1268305|NCT00373386|Secondary|Glucose|Plasma glucose|3 months||||mg/dl||Standard Deviation|Mean
1268306|NCT00373386|Primary|Reactive Hyperemic Response After 3 Months of Growth Hormone|Forearm blood flow (FBF) was measured using strain gauge venous occlusion plethysmography using a Hokanson EC6 plethysmograph (DE Hokanson Inc, Bellevue, WA) in the left arm. With this technique sphygmomanometric cuffs were placed on the arm at the wrist and on the upper arm. During measurement the wrist cuff was inflated to 200 mmHg to occlude flow to the hand which is primarily skin blood flow and the upper arm cuff is inflated to 40 mmHG for 10 out of every 15 second to occlude venous return. FBF was obtained by measuring arm expansion with an indium-in-silastic strain gauge. Data was recorded using PowerLab and Chart 4.0 (AD Instruments, Grand Junction, CO) on a Power Mac G4 computer (Apple, Cupertino, CA).For each subject two minutes of baseline FBF were recorded and then the upper arm cuff was inflated to 200 mmHg pressure for five minutes to occlude flow to the arm. It was then released and forearm blood flow was measured for the next minute.|3 months||||ml/dl min||Standard Error|Mean
1268307|NCT00373360|Secondary|Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||number of times per day||Standard Deviation|Mean
1268308|NCT00373360|Secondary|Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||number of times per day||Standard Deviation|Mean
1268309|NCT00373360|Secondary|Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||number of times per day||Standard Deviation|Mean
1268310|NCT00373360|Secondary|Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||minutes||Standard Deviation|Mean
1268311|NCT00373360|Secondary|Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||minutes||Standard Deviation|Mean
1268312|NCT00373360|Secondary|Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||minutes||Standard Deviation|Mean
1268313|NCT00373360|Secondary|Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||minutes||Standard Deviation|Mean
1268314|NCT00373360|Secondary|Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8|Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied.|Baseline and Week 8||||participants|||Number
1268315|NCT00373360|Secondary|Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8|Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more.|Baseline and Week 8||||participants|||Number
1268316|NCT00373360|Secondary|Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8|Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse.|Baseline and Week 8||||participants|||Number
1268317|NCT00373360|Secondary|Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1268318|NCT00373360|Secondary|Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1269303|NCT00365846|Secondary|Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)||3 years||||participants|||Number
1269304|NCT00365846|Primary|Incidence of Allograft Rejection||3 years||||participants|||Number
1268319|NCT00373360|Secondary|Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1268320|NCT00373360|Secondary|Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1268321|NCT00373360|Secondary|Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1268322|NCT00373360|Secondary|Change in Symptoms of Chest Pain From Baseline to Week 8|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
1268323|NCT00373360|Secondary|Change in Symptoms of Syncope From Baseline to Week 8|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
1268324|NCT00373360|Secondary|Change in Symptoms of Fatigue From Baseline to Week 8|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
1268325|NCT00373360|Secondary|Change in Symptoms of Dizziness From Baseline to Week 8|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
1268326|NCT00373360|Secondary|Change in Symptoms of Orthopnea From Baseline to Week 8|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
1268327|NCT00373360|Secondary|Change in Symptoms of Edema From Baseline to Week 8|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Baseline to Week 8||||percentage of participants|||Number
1268328|NCT00373360|Secondary|Change in Symptoms of Dyspnea From Baseline to Week 8|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
1268329|NCT00373360|Secondary|Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Baseline and Week 8||||percentage of participants|||Number
1268330|NCT00373360|Secondary|Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1268331|NCT00373360|Primary|Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.||Baseline and Week 8|"As this was a small open label study, the statistics applied to the results were descriptive. For all efficacy endpoints, data obtained from study assessments during the treatment phase were compared to Baseline.~assessments"|||meters||Standard Deviation|Mean
1268332|NCT00373334|Secondary|Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity|Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.|8 weeks|The analysis population includes all patients that took drug and reached the 8 week study timepoint.|||participants|||Number
1268333|NCT00373334|Secondary|Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief|Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.|8 weeks|The analysis population includes all patients that took drug and reached the 8 week study timepoint.|||participants|||Number
1268682|NCT00371254|Secondary|Mean Change in Concentration of Collagen Type IV From Baseline|Collagen Type IV is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of Collagen Type IV were obtained and analyzed by enzyme-linked immunosorbent assay.|Baseline, Week 3 and Week 5|Participants who were evaluable for pharmacodynamic analysis.|||percentage of baseline||90% Confidence Interval|Geometric Mean
1268334|NCT00373334|Primary|Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success|The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.|8 weeks|The analysis population includes all patients that took drug and had any efficacy data reported. 5 patients that were lost to follow up (1 nizatidine 2.5 group, 1 nizatidine 5.0 group, 3 placebo group) were not included because they had no efficacy data and had not reported any adverse events.|||participants|||Number
1268335|NCT00373295|Primary|Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase|"This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke.~Over each 3 day period, the puffs chosen by each participant is averaged for a single value."|Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)||||dollars spent on marijuana||Standard Deviation|Mean
1268336|NCT00373269|Secondary|TF-PCA|TF-PCA levels compared between normoglycemic and hyperglycemic subjects.|Baseline||||U/ml||Standard Deviation|Mean
1268337|NCT00373269|Primary|FVIIa|FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.|Baseline||||mU/ml||Standard Deviation|Mean
1268338|NCT00373256|Secondary|Biomarkers|Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 [VEGFR2] and VEGFR3, VEGF-A, placental growth factor [PlGF], soluble KIT, and possibly soluble PDGFRβ and PDGF) that may be associated with angiogenesis and tumor proliferation.|Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1|ITT. Biomarker data were collected, but since the study was stopped early and there were too few events of OS, PFS, etc, data were not analyzed.||||||
1268339|NCT00373256|Secondary|EQ - Visual Analog Scale (EQ-VAS)|EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EQ-VAS evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.||||||
1268340|NCT00373256|Secondary|Euro Quality of Life-5 Dimension (EQ-5D)|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EQ-5D evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.||||||
1268341|NCT00373256|Secondary|EORTC QLQ Breast Cancer Module (BR23)|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. BR23 evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.||||||
1268342|NCT00373256|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EORTC QLQ-C30 evaluations were not analyzed since enrollment in this study was terminated early for futility.||||||
1268343|NCT00373256|Secondary|Percentage of Participants Surviving at 1 and 2 Years|Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.|Year 1, Year 2|ITT.|||percentage of participants|||Number
1268344|NCT00373256|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.|From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.|ITT. The median OS for bevacizumab + paclitaxel at the time of data cut off was not reached; therefore, it could not be calculated.|||Months||95% Confidence Interval|Median
1268345|NCT00373256|Secondary|Duration of Response (DR)|DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as [the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)] divided by 30.4.|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause|ITT. DR was calculated for the subgroup of subjects with objective response. 78 subjects reported CR or PR response and were analyzed for DR in each treatment group.|||Months||95% Confidence Interval|Median
1268346|NCT00373256|Secondary|Number of Participants With Objective Response|Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months|ITT|||participants|||Number
1268347|NCT00373256|Primary|Progression-Free Survival (PFS)|Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death|The intent-to-treat (ITT) population included all patients who were randomized.|||Months||95% Confidence Interval|Median
1268348|NCT00373113|Secondary|EORTC QLQ Breast Cancer Module (BR23)|"BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.~Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms."|From Day 1 of Cycle 1, then odd numbered cycles thereafter|The study was stopped early for futility and EORTC QLQ Cancer Module (BR23) analysis was not performed.|||scores on a scale||Standard Deviation|Mean
1268349|NCT00373113|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|"EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).~Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms."|From Day 1 of Cycle 1, then odd numbered cycles thereafter|The study was stopped early for futility and EORTC QLQ-C30 analysis was not performed.|||scores on a scale||Standard Deviation|Mean
1268350|NCT00373113|Secondary|Overall Survival (OS)|Average time from randomization to first documentation of death due to any cause.|From time of randomization until death|ITT population|||Months||95% Confidence Interval|Median
1268351|NCT00373113|Secondary|Time to Tumor Response (TTR)|Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months|The study was stopped early for futility and TTR analysis was not performed.|||Months||95% Confidence Interval|Median
1268352|NCT00373113|Secondary|Duration of Response (DR)|Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months or death|ITT population. DR was calculated for the subgroup of participants with objective response. 27 participants in the sunitinib arm and 40 participants in the capecitabine arm reported CR or PR response and were analyzed for DR.|||Months||95% Confidence Interval|Median
1268353|NCT00373113|Secondary|Number of Participants With Overall Response (OR)|OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months|ITT population|||Participants|||Number
1268354|NCT00373113|Secondary|Time to Tumor Progression (TTP)|Time from randomization to first documentation of objective tumor progression.|From time of randomization to every 6 weeks thereafter through 22 months|ITT population|||Months||95% Confidence Interval|Median
1268355|NCT00373113|Primary|Progression-Free Survival (PFS)|Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.|From time of randomization to every 6 weeks thereafter through 22 months or until death|Intent-to-treat (ITT) population: included all participants who were randomized.|||Months||95% Confidence Interval|Median
1268356|NCT00372996|Secondary|EORTC QLQ Breast Cancer Module (BR23) Scores|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 â€˜Not at Allâ€™ to 4 â€˜Very Muchâ€™). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months|The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
1268357|NCT00372996|Secondary|European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.|Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months|The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
1268358|NCT00372996|Secondary|Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway||Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy|The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
1268359|NCT00372996|Secondary|Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)||Predose on Day 1 of Cycle 1|The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
1269305|NCT00365768|Secondary|Number of Participants With Progression of Neuropathy||42 days||||participants|||Number
1268360|NCT00372996|Secondary|Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)|Negative human anti-human antibodies were defined as <6.64|Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion|All randomized participants who started treatment and who had at least 1 sample submitted for the biomarker; collection of samples for this analysis was stopped after Amendment 6. All samples were negative to HAHA.|||participants|Participants||Number
1268361|NCT00372996|Secondary|Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
1268362|NCT00372996|Secondary|Minimum Plasma Concentration of CP-751,871||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
1268363|NCT00372996|Secondary|Maximum Plasma Concentration of CP-751,871||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and pharmacokinetic (PK) sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
1268364|NCT00372996|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months|Objective responses were defined using RECIST as CR: disappearance of all target and nontarget lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Nontarget lesions may persist provided there is no unequivocal progression in these lesions. SD: measurements demonstrating neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) during the first 6 weeks after the start of treatment taking as reference the smallest sum LD since the treatment started. During this time, nontarget lesions may persist provided there is no unequivocal progression in these lesions.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|FAS|||percentage of participants||95% Confidence Interval|Number
1268365|NCT00372996|Primary|PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline|PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|FAS; only participants with baseline HbA1c <5.7% were included in the analysis.|||months||95% Confidence Interval|Median
1268366|NCT00372996|Primary|Progression-Free Survival (PFS)|PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent [%] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors [RECIST]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|Full Analysis Set (FAS): all enrolled participants; grouped by randomized arm, where the first 10 participants enrolled but not randomly assigned to treatment were not included.|||months||95% Confidence Interval|Median
1268367|NCT00372970|Primary|Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index.|"Scale for GI symptoms related to gastroparesis. For this we will use the gastroparesis cardinal symptom index (GCSI).~The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Scores range from 0-5 for the nine items and an asymptomatic patient would have a score of 0 with a highly symptomatic patient having a score of 45. For this study the score had to be >=27. In a previous study internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores."|1 month|All patients had gastroparesis and underwent EGD. Injection double blinded.|||units on a scale||Standard Deviation|Mean
1268393|NCT00372775|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|A single blood sample (4 milliliters [mL]) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.|Day 1 of Week 5, 9, and 13|ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1269306|NCT00365768|Primary|Incidence of Vincristine-induced Peripheral Neuropathy||Up to 30 weeks from baseline while on Vincristine treatment||||participants|||Number
1268368|NCT00372957|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is serious corresponding to those listed in above definition.|Up to post-study screen (Follow-up [7 days after the last dose of study medication])|Safety Population comprised of all participants who received study medication (active or placebo).|||Participants|||Count of Participants
1268369|NCT00372957|Primary|Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of plasma glucose concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing sodium fluoride, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment – time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1268370|NCT00372957|Primary|C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of plasma C-peptide concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment – time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||ng/mL||Standard Deviation|Mean
1268371|NCT00372957|Primary|Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of plasma glucagons concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing aprotinin, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment – time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||Picogram per milliliter (pg/mL)||Standard Deviation|Mean
1268372|NCT00372957|Primary|Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of plasma insulin, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment – time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||Micro units per milliliter (µU/mL)||Standard Deviation|Mean
1268373|NCT00372957|Primary|Active Glucagon-like Peptide-1 (GLP-1) Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of active GLP-1 concentrations, approximately 3 mL of whole blood was collected into a vacuum tube containing DPP-IV inhibitor, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment – time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||Picomole (pM)||Standard Deviation|Mean
1268394|NCT00372775|Secondary|Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score|Change from baseline in FBrSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 60. Higher scores indicated better outcomes.|Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)|ITT population of participants with post baseline patient-reported outcome data|||Scores on a scale||95% Confidence Interval|Mean
1268683|NCT00371254|Secondary|Mean Plasma Concentration at Week 7|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose and 1, 3, 6 and 12 hours after each dose administration|"Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point."|||nanograms (ng)/mL||Standard Deviation|Mean
1268374|NCT00372957|Primary|DPP-IV Activity Weighted Mean AUCs at Baseline (Day -1) and Day 7|For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2K and centrifuged at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment – time of first assessment in hr). Double-delta analysis has been presented in analysis. Unit of measure: Nano mole per minute per milliliter (nmol/min/mL).|Baseline (Day -1) and Day 7|Pharmacodynamic (PD) Parameter Population comprised of all participants who received study medication (active or placebo) and for whom PD data was available.|||nmol/min/mL||Standard Deviation|Mean
1268375|NCT00372957|Primary|Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7)|For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing ethylenediamine tetraacetic acid (EDTA2K) and centrifuged at approximately 4 degree Celsius, at approximately 2500 revolution per minute (rpm) for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. DPP-IV inhibition was estimated by using the percent change from pre-dose of DPP-IV activity. DPP-IV inhibition was done at pre-dose, 0.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr and 24 hr.|Day 7|Pharmacodynamic (PD) Parameter Population comprised of all participants who received study medication (active or placebo) and for whom PD data was available.|||Percent inhibition|||Number
1268376|NCT00372957|Primary|Standard PK Parameter: R[Cmax], Extent of Accumulation (Ro), Steady State Accumulation Ratio (Rs)|PK parameters were calculated using data at the actual time of blood collection. R[Cmax], Ro and Rs were determined from plasma concentration-time data, using standard model independent methods. R[Cmax] = Cmax (Day 7)/Cmax (Day 1), Ro = AUC(0-tau) (Day 7)/ AUC(0-tau) (Day 1) and Rs = AUC(0-tau) (Day 7)/ AUC(0-inf) (Day 1).|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Ratio||95% Confidence Interval|Geometric Mean
1268377|NCT00372957|Primary|Standard PK Parameter: Apparent Volume of Distribution (Vz/F)|PK parameters were calculated using data at the actual time of blood collection. Vz/F was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||L||95% Confidence Interval|Geometric Mean
1268378|NCT00372957|Primary|Standard PK Parameter: Total Clearance (CL/F)|PK parameters were calculated using data at the actual time of blood collection. CL/F was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
1268379|NCT00372957|Primary|Standard PK Parameter: Constant Rate of Elimination (lambda_z)|PK parameters were calculated using data at the actual time of blood collection. Lambda_z was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||1/hr||95% Confidence Interval|Geometric Mean
1268380|NCT00372957|Primary|Standard PK Parameter: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)|PK parameters were calculated using data at the actual time of blood collection. %AUCex was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Percentage of AUCex||95% Confidence Interval|Geometric Mean
1268381|NCT00372957|Primary|Standard PK Parameter: Area Under the Plasma Drug Concentration Versus Time Curve Extrapolated to Infinity (AUC[0-inf]), AUC From 0 to the Last Measurable Concentration (AUC[0-t])|PK parameters were calculated using data at the actual time of blood collection. AUC[0-inf] and AUC[0-t] was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Hr.ng/mL||95% Confidence Interval|Geometric Mean
1268382|NCT00372957|Primary|Standard PK Parameter: Half Life of Terminal Elimination Phase (t1/2)|PK parameters were calculated using data at the actual time of blood collection. T1/2 was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Hour||95% Confidence Interval|Geometric Mean
1268383|NCT00372957|Primary|Standard PK Parameter: Time at Which Cmax Was Observed (Tmax)|PK parameters were calculated using data at the actual time of blood collection. Tmax was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Hour||Full Range|Median
1268384|NCT00372957|Primary|Standard Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Drug Concentration (Cmax)|PK parameters were calculated using data at the actual time of blood collection. Cmax was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hours [hr]), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population comprised of all participants who received an active dose of GW823093C and for whom PK data was collected.|||Nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1268395|NCT00372775|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score|Change from baseline in FLSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 24. Higher scores indicated better outcomes.|Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)|ITT population of participants with post baseline patient-reported outcome data|||Scores on a scale||95% Confidence Interval|Mean
1268396|NCT00372775|Secondary|Number of Deaths Due to Intracranial Versus Systemic Progression|Number of deaths determined to be intracranial versus systemic progression, according to investigators’assessment.|Baseline until death (up to 1 year)|ITT|||Participants|||Number
1268385|NCT00372905|Post-Hoc|Median Progression Free Survival|"Median progression free survival (PFS) will be assessed by CT scans after induction therapy, consolidation therapy, every 3 months for the first year following treatment and every 6 months for the second year.~Progressive disease is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size or at least a 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis."|At start of treatment, at completion of induction therapy, at completion of consolidation therapy, every 3 months for 1 year, and every 6 months for 1 year|The first 9 patients data that were enrolled in the phase I dose escalation portion were collected, analyzed and reported on. Cohort results for this outcome measure are combined as the objective was to determine the PFS of patients with this drug combination (dose was irrelevant)|||Months||Full Range|Median
1268386|NCT00372905|Post-Hoc|Overall Response Rate|"The overall response rate at the completion of treatment was defined as complete response plus partial response.~Complete response (CR)=A post-treatment residual mass of any size is permitted as long as it is PET-negative and normalization of those biochemical abnormalities.~Partial response (PR)=50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in the size of the other nodes, liver or spleen, and no new sites of disease.~Stable disease=Failing to attain the criteria for PR or CR, but not fulfilling those for progressive disease.~Progressive disease(PD)=At least a 50% increase from nadir in the SPD of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size."|At baseline, after induction cycle (1 cycle =28 days) and consolidation therapy of a maximum of 3 cycles (1cycle =28 days), up to approximately 6 months|Data for first 9 patients enrolled in phase I dose escalation portion of the study were collected, analyzed and reported on. Cohort results for this outcome measure are combined as the objective was to determine the ORR of patients with this drug combination (dose was irrelevant)|||percentage of patients|||Number
1268387|NCT00372905|Secondary|Number of Patients With Adverse Events Related to Treatment of Bortezomib Combined With Y-90-ibritumomab Tiuxetan|"To further explore the toxicity bortezomib combined with Y-90-ibritumomab tiuxetan by collecting data on adverse events (AE) reported by patient or collected lab results that are grade 3 or grade 4 that were determined to be at least possible related to any of the studies drugs.~Toxicity will be collected on treatment days according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|At start of treatment on days 1, 8, 15, 22 of induction, days 36 and 50 of recovery, days 1, 8, 15 of consolidation cycles for up to 3 cycles and 4 weeks after the completion of treatment.|Toxicity data for 9 patients enrolled in the dose escalating cohorts 1, 2 and 3 was collected and analyzed only. Data for the 3 cohorts are presented combined as the objective is to report grade 3 and 4 toxicities with this combination of drugs (dose of bortezomib is irrelevant)|||Participants|||Count of Participants
1268388|NCT00372905|Primary|Maximum Tolerated Dose (MTD) and Tolerability of Bortezomib Combined With Y-90-Ibritumomab Tiuxetan Determined by Number of Dose Limiting Toxicities in a Cohort.|"To determine the MTD using a 3+3 dose escalating design. There will be 3 dose cohorts:1.0mg/m2,1.3mg/m2 and1.6 mg/m2. 3 patients will be enrolled at dose of 1.0mg/m2 bortezomib. If no dose limiting toxicities (DLTs) are seen in the first 3 patients then dose will be escalated to next level and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced.~DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0.~DLTs=grade 3 nausea, vomiting, diarrhea or ileus more than 96h; grade 4 nausea, vomiting, diarrhea or ileus,neuropathic pain, peripheral sensory neuropathy, neutropenia, thrombocytopenia."|During induction therapy, the first 28 days of treatment.|Patients enrolled in dose escalation cohorts 1, 2 and 3 analyzed for this outcome measure.|||DLT|||Number
1268389|NCT00372775|Secondary|PFS in Subgroups Defined by RNA Expression Profiles of Tumors|PFS defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was to be determined in subgroups defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT3, KIT, and RET) level (low/high relative to expression of Glyceraldehyde-3-Phosphate Dehydrogenase [GAPDH] reference gene). PFS calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Day 1 of Week 1 and every 4 weeks up to 1 year|ITT. Only 4 RNA samples were collected and no statistical analyses performed.|||weeks||90% Confidence Interval|Median
1268390|NCT00372775|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile|Tumor samples were not anonymized. RNA expression profile was to include colony-stimulating factor 1 receptor (CSF-1R), platelet-derived growth factor receptor alpha and beta (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor (VEGF), VEGF-C, VEGF receptor 1, 2, and 3 (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF), FMS-like tyrosine kinase 3 (FLT3), KIT (stem cell factor receptor), and RET (rearranged during transfection).|Day 1 of Week 1 and every 4 weeks up to 1 year|ITT. Only 4 RNA samples were collected and no statistical analyses performed.|||Percentage of participants|||Number
1268391|NCT00372775|Secondary|Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts|A blood sample (6mL) collected before treatment with Sunitinib and used to isolate deoxyribonucleic acid (DNA). These samples were not anonymized.|Day 1 prior to dosing|ITT. c-Kit, Flt-3 and c-Fms with blood count samples collected; however, no statistical analyses performed since power was insufficient.|||picograms per milliliter (pg/mL)|||Number
1268392|NCT00372775|Secondary|Ctrough of Sunitinib Metabolite (SU012662)|A single blood sample (4 mL) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.|Day 1 of Week 5, 9, and 13|ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.|||ng/mL||Standard Deviation|Mean
1268399|NCT00372775|Secondary|Duration of Response (DR)|DR defined as difference in weeks between first date criteria for progression occurred, or participant died due to any cause and first date that criteria for a PR or CR were met and subsequently confirmed ≥4 weeks later. Since day criteria for PR or CR were met and first day criteria for progression occurred (or participant died) were each counted as a full day, 1 day was added to each calculation. DR (in weeks) calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.|Day 7 of Week 4 and every 4 weeks up to 1 year|ITT. DR only calculated for the subgroup of participants with an objective tumor response.|||Weeks|||Number
1268400|NCT00372775|Secondary|Number of Participants With Intracranial Objective Disease Response|Intracranial objective disease response defined as participants with confirmed CR or PR, according to WHO criteria. CR defined as disappearance of all enhancing tumor. PR defined as a ≥50% reduction from baseline in sum of the products of all enhancing tumors.|Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49|ITT with measurable intracranial disease at baseline.|||Participants|||Number
1268401|NCT00372775|Secondary|Time to Objective Intracranial Progression|Time in weeks from start of study treatment to first documentation of objective intracranial tumor progression. Intracranial tumor progression defined as ≥25% increase from smallest size in sum of products of all enhancing tumors or appearance of any new tumor, according to World Health Organization (WHO) criteria. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day added to each calculation. Time to Objective Intracranial Progression = (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)|ITT|||Weeks||95% Confidence Interval|Median
1268402|NCT00372775|Secondary|Number of Participants With Objective Disease Response|Objective disease response defined as participants with confirmed complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49|ITT with measurable disease at baseline.|||Participants|||Number
1268403|NCT00372775|Secondary|Time to Neurological Progression (TNP)|Time in weeks between first date criteria for focal neurological deficit were met and date of first dose of medication. Criteria for focal neurological deficit included speech or language difficulties, vision changes, loss of coordination or fine motor control, and seizures. Since day of first dose of medication and day criteria for focal neurological deficit were met were each counted as a full day, 1 day was added to each calculation. TNP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 28 to focal neurological deficit (up to 1 year)|ITT|||Weeks||Full Range|Median
1268404|NCT00372775|Secondary|Time to Tumor Progression (TTP)|Time from start of study treatment to first documentation of objective tumor progression. Tumor progression defined as greater than or equal to 20 percent (≥20%) increase in sum of longest dimensions of target lesions using as reference smallest sum of longest dimensions recorded since treatment started, or unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST). TTP = (first event date minus date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)|ITT|||Weeks||95% Confidence Interval|Median
1268405|NCT00372775|Primary|Progression-Free Survival (PFS)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)|Intent-to-treat (ITT): all participants enrolled in the study who received at least 1 dose of study medication.|||Weeks||90% Confidence Interval|Median
1268406|NCT00372697|Secondary|Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)|The AcroQoL contains 14 items on Psychological aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the psychological scale ranges from 14-70. A higher score indicates better Quality of Life.|End of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.|||Percent of maximum score||Standard Deviation|Mean
1268407|NCT00372697|Secondary|Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)|The AcroQoL contains 8 items on Physical aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the physical scale can range from 8-40. A higher score indicates better Quality of Life.|End of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.|||Percent of maximum score||Standard Deviation|Mean
1268408|NCT00372697|Secondary|Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)|The investigator asked the participant to score the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0=absent; 1=mild; 2=moderate; 3=severe, but not disabling; 4=severe and disabling). The percentage of asymptomatic participants, ie, with a score of 0 for all symptoms, was calculated.|Week 12 and end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.|||Percentage of participants|||Number
1268698|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|3 month follow-up||||units on a scale||Standard Deviation|Mean
1268409|NCT00372697|Secondary|Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)|A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.|||Percentage of participants|||Number
1268410|NCT00372697|Secondary|Change in Tumor Volume From Screening to End of Study (Week 24)|A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.|||mm^3||Standard Deviation|Mean
1268411|NCT00372697|Primary|Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)|Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.|||µg/L||Standard Deviation|Mean
1268412|NCT00372697|Primary|Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)|Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.|||µg/L||Standard Deviation|Mean
1268413|NCT00372619|Secondary|Correlate the Expression of Apoptosis Specific Genes|Correlate the expression of apoptosis specific genes with chemoresistance and determine whether therapy with clofarabine is able to overcome blocks in apoptosis through modulation of gene expression. Gene expression analysis will be performed on specimens obtained during therapy. Apoptosis specific microarray data will be analyzed using GeneTraffic software (Iobion Informatics, La Jolla CA).|End of therapy|The analysis was not completed, because the tissue microarray was unsuccessful.||||||
1268414|NCT00372619|Secondary|Safety and Tolerability as Measured by CTCAE v3.0|Number of participants with at least one grade 3 or higher adverse event during therapy.|End of therapy|Ineligible (n=2) and inevaluable (n=1) patients are excluded|||number participants|||Number
1268415|NCT00372619|Primary|Overall Response (CR for ALL Patients), (CR + CRp for AML Patients)|"Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) > 750/μL and platelet count > 75,000/μL).~Overall response for AML patients: (CR + CRp), defined as:~CR - complete remission (attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) > 1000/uL and platelet count > 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) > 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week))."|2 cycles or up to 84 days||||participants|||Number
1268416|NCT00372593|Secondary|Toxicities, Including Infectious Complications|Number of participants with at least one grade 3 or higher adverse event during therapy.|From the time therapy is initiated, assessed up to 10 years|Ineligible (n=42) patients are excluded.|||Number of participants|||Number
1268417|NCT00372593|Secondary|Time to Marrow Recovery|Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.|At 25 days after treatment with Induction I, Induction II, and Intensification I|Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182)|||Mean days||Standard Deviation|Mean
1268418|NCT00372593|Secondary|Mortality|Number of participants who died during the first three courses of therapy.|During the first three courses of therapy|Ineligible (n=42) patients are excluded.|||Number of participants|||Number
1268419|NCT00372593|Secondary|Disease-free Survival (DFS)|Time from end of Intensification I to relapse, death or last contact|At 3 years from end of Intensification I|Ineligible (n=42) patients are excluded. Patients who did not continue on therapy at end of Intensification I are also excluded (n=247).|||Percentage participants DFS at 3 years||95% Confidence Interval|Number
1268420|NCT00372593|Secondary|Remission Induction Rate After 2 Courses of Induction Therapy|Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II.|After 2 courses of induction (I and II) therapy, assessed for up to 10 years|Ineligible (n=42) patients are excluded. Patients without an evaluable bone marrow at the end of Induction I or at the end of Induction II are excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable (n=45).|||Proportion of participants|||Number
1268421|NCT00372593|Primary|Overall Survival at 3 Years|The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.|Time from study entry, assessed at 3 years|Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.|||percentage of participants||95% Confidence Interval|Number
1268422|NCT00372593|Primary|Event-free Survival at 3 Years|The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.|Time from study entry to time of induction failure, relapse, or death, assessed at 3 years|Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.|||percentage of participants||95% Confidence Interval|Number
1268423|NCT00372567|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm|EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.|||Scores on a scale||Standard Deviation|Mean
1268424|NCT00372567|Secondary|Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm|"EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state."|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.|||Scores on a scale||Standard Deviation|Mean
1268425|NCT00372567|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm|EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.|||Scores on a Scale||Standard Deviation|Mean
1268426|NCT00372567|Secondary|Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state."|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.|||Scores on a scale||Standard Deviation|Mean
1268427|NCT00372567|Secondary|Number of Participants With Pain Progression|Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.|||Participants|||Number
1268428|NCT00372567|Secondary|Number of Participants With Pain Relief Response|Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.|||Participants|||Number
1268429|NCT00372567|Secondary|Time to Pain Progression (TTPP)|TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with an event.|||Days||95% Confidence Interval|Median
1268430|NCT00372567|Secondary|Duration of Response (DR)|"Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.~Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions."|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with an objective tumor response. DR data censored on the day following the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study.|||Weeks||Full Range|Median
1268431|NCT00372567|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 26|ITT|||Weeks||95% Confidence Interval|Median
1268699|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|Post Intervention||||units on a scale||Standard Deviation|Mean
1268700|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|Post intervention||||units on a scale||Standard Deviation|Mean
1268432|NCT00372567|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 26|ITT|||Participants|||Number
1268433|NCT00372567|Secondary|Time to Treatment Failure (TTF)|TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with treatment failure.|||Months||95% Confidence Interval|Median
1268434|NCT00372567|Secondary|Time to Pain Relief Response (TTPR)|Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT|||Days||95% Confidence Interval|Median
1268435|NCT00372567|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.|Baseline up to 2 years|ITT|||Months||95% Confidence Interval|Median
1268436|NCT00372567|Primary|Progression-Free Survival (PFS)|Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.|Baseline, Week 5, and every 8 weeks until Year 2|Intention to treat (ITT): all participants in Main Study (Phase 3) who were randomized, regardless of whether the participant received any drug or received a different drug from that to which they were randomized. Number of participants analyzed: participants who had a PFS event (progressive disease or death).|||Months||95% Confidence Interval|Median
1268437|NCT00372528|Secondary|Mean Number of Seizures|Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.|Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)|SAS included all participants who had received at least 1 dose of study medication in the open label period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable between each visit.|||Seizures||Standard Deviation|Mean
1268438|NCT00372528|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Year 5 and follow-up (30 days after last dose)|Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period.|||Participants|||Number
1268439|NCT00372489|Primary|Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change||Up to 54 months|Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change|||percentage of participants|||Number
1268440|NCT00372424|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Paclitaxel||End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6|Data not analyzed since paclitaxel was not administered in the study.||||||
1268441|NCT00372424|Secondary|Plasma Trough Concentrations (Ctrough) of Trastuzumab|Ctrough = the concentration prior to study medication administration.|Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6|Data was not summarized since majority of observed Ctrough values were below lower limit of quantification.||||||
1268442|NCT00372424|Secondary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel|Concentration values below the lower limit of quantification were taken as zero.|End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6|PK analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.|||ng/mL||Standard Deviation|Mean
1268443|NCT00372424|Secondary|Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)|Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.|Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1|Pharmacokinetic (PK) analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1268444|NCT00372424|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Study population, subgroup of participants with a confirmed objective tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
1268701|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|Pre Intervention||||units on a scale||Standard Deviation|Mean
1269404|NCT00365105|Secondary|Overall Survival||From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome.|||||||
1268445|NCT00372424|Secondary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Study population included all participants who received at least 1 dose of study medication.|||weeks||95% Confidence Interval|Median
1268446|NCT00372424|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Per protocol (PP) population included all participants who received at least 1 dose of sunitinib and had at least a tumor assessment post baseline.|||percentage of participants||95% Confidence Interval|Number
1268447|NCT00372424|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From screening until 28 days post last dose of study drug|Safety population included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
1268448|NCT00372411|Secondary|Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline|The Modified Ashworth Scale for spasticity is a measurement of spasticity across 9 muscle groups. Each muscle group is scored on a 0 to 5 scale with higher scores indicating worse functioning. The total score is the average score from the 9 muscle groups and ranges from 0 to 5 with higher scores indicating worse functioning.|12 weeks minus baseline||||units on a scale||Standard Error|Least Squares Mean
1268449|NCT00372411|Secondary|Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline|The Numeric Rating Scale (NRS) for pain is a self report scale ranging from 0 (no Pain) to 10 (pain as bad as you can imagine).|12 weeks minus baseline||||units on a scale||Standard Error|Least Squares Mean
1268450|NCT00372411|Secondary|Wolf Motor Function Test|The Wolf Motor Function Test (WMFT) is a functionally-based test designed to provide an objective measure of both proximal (during tasks such as lifting the hand from table to box top) and distal control (grasping pencil, bringing soda can to mouth) of the paretic arm for patients after stroke or traumatic brain injury. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds, with higher scores indicating worse functioning. Outcome measure is the change in the Wolf score at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline||||Seconds||Standard Error|Least Squares Mean
1268451|NCT00372411|Secondary|Stroke Impact Scale|The Stroke Impact Scale (SIS) is stroke specific, self-reported measure that evaluates function and quality of life in eight clinically relevant domains. The domains of hand function, activities of daily living, instrumental activities of daily living, mobility, and social participation were used; total score ranges from 0 to 100 with higher values indicating better functioning. Outcome is change at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline||||units on a scale||Standard Error|Least Squares Mean
1268452|NCT00372411|Primary|Fugl-Meyer Assessment for Motor Recovery (FM) Scale|Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline|All participants with baseline and follow-up measures were included by intention-to-treat|||units on a scale||Standard Error|Least Squares Mean
1268453|NCT00372385|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1268454|NCT00372385|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).|||participants|||Number
1268467|NCT00372112|Secondary|Cmax of GW630200 and GSK932009 at Day 1, 7 and 14|GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1269405|NCT00365105|Secondary|SRE Rate at 1 Year||From randomization to 1 year|||||||
1268455|NCT00372385|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||participants|||Number
1268456|NCT00372385|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|Completion of study drug dosing (up to Week 48)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1268457|NCT00372385|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|12 weeks after the completion of study drug dosing (up to Week 60)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1268458|NCT00372385|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1268459|NCT00372190|Secondary|Bulge Symptoms|"Bulge symptoms defined as Prolapse domain score of the Urogenital Distress Inventory (UDI) at 12 months.~Scores range from 0 (least/no bother) to 100 (maximum bother)"|12 months||||units on a scale||Standard Deviation|Mean
1268460|NCT00372190|Secondary|"Patient Global Impression of Improvement (PGI-I) at 12 Months"|Number of participants with much to very much improvement compared to baseline|at 12 months||||participants|||Number
1268461|NCT00372190|Secondary|Mesh Exposure at 12 Months|cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)|12 months||||participants|||Number
1268462|NCT00372190|Primary|"Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months"|"Number of participants with anatomic failures defined as Pelvic Organ Prolapse (POP) stage II or higher"|12 months||||participants|||Number
1268463|NCT00372112|Secondary|Tmax of Salmeterol at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
1268464|NCT00372112|Secondary|Cmax of Salmeterol at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1268465|NCT00372112|Secondary|AUC (0-4) of Salmeterol at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1268466|NCT00372112|Secondary|Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14|GW630200 and GSK932009 are metabolites of GW642444H. CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
1268492|NCT00372112|Secondary|Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14|HR was measured using 28.5 h ABPM. The assessments for maximum HR were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14.|Day 1 up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
1268468|NCT00372112|Secondary|AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14|GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1268469|NCT00372112|Secondary|Cmax of CCI2189 at Day 1, 7 and 14|CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1268470|NCT00372112|Secondary|AUC (0-4) of CCI2189 at Day 1, 7 and 14|CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)*h/mL||Geometric Coefficient of Variation|Geometric Mean
1268471|NCT00372112|Secondary|Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed and tlast was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
1268472|NCT00372112|Secondary|Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1268473|NCT00372112|Secondary|AUC of GW642444H Over 0 to 4 h (AUC [0–4]) on Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC over 4 h as AUC from zero (pre-dose) to 2 h post-dose (AUC [0-2]), AUC from zero (pre-dose) to 4 h post-dose (AUC [0-4]) and AUC from zero (pre-dose) to time of last quantifiable concentration (AUC [0-t]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|Pharmacokinetic (PK) Concentration Population comprised of those participants in the Safety Population for whom a PK sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.|||Picogram (pg)*h/mL||Geometric Coefficient of Variation|Geometric Mean
1268474|NCT00372112|Secondary|Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time|Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
1268475|NCT00372112|Secondary|Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time|Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the assessment on Day 1 pre-dose. The weighted mean change from Baseline was the AAUCMB. Change from Baseline in maximum glucose 0-4 h and minimum potassium 0-4 h was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1 to Day 15) values.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
1268476|NCT00372112|Secondary|Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14|Blood samples were collected at pre-dose on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on pre-dose, Day 1. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 7 and Day 14) values.|Baseline (Day 1, pre-dose) up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimole (mmol)/L)||Standard Deviation|Mean
1274993|NCT00316017|Secondary|Packed Red Blood Cells (PRBC) First 24 Hours|The numbers of units of packed red blood cells transfused in the first 24 hours|First 24 hours from the time of 911 call||||units of packed red blood cells||Standard Deviation|Mean
1268477|NCT00372112|Secondary|Number of Participants With Rescue Free Days|Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The percentage of rescue free days during the Run-in week, Week 1, Week 2 and Follow-up Week were assessed. Data is reported for number of participants with < 20%, >=20 to <40%, >=40 to <60%, >=60 to <80% and >=80% rescue free days.|Up to Follow-up (Day 17)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1268478|NCT00372112|Secondary|Mean Use of Rescue Medication Over Period|Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The mean of 7 days (puffs per 24 h) were reported for the Run-in Week, Week 1, Week 2 and Follow-up.|Up to Follow-up (Day 17)|Safety Population. Only those participants available at the specified time points were analyzed.|||Puffs per 24 h||Standard Deviation|Mean
1268479|NCT00372112|Secondary|Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time|PEF is a measure of lung function and measures how fast a person can breathe out. It was measured using a peak flow meter by the participants and recorded on daily record cards each day in the morning and evening from Screening up to Follow-up. The morning measurements were performed prior to the participant taking the morning dose of study medication or rescue medication. The evening measurements were performed prior to the participant taking the evening dose of study medication or rescue medication. The highest of the 3 values of morning and evening PEF were recorded on the diary card. The mean of 7 days of each morning and evening measurements were reported for the Run-in Week, Week 1, Week 2 and Follow-up.|Up to Follow-up (Day 17)|Safety Population. Only those participants available at the specified time points were analyzed.|||Liters per minute (L/min)||Standard Deviation|Mean
1268480|NCT00372112|Secondary|Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14|FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 over 22-24 h was obtained at Day 1, Day 7 and Day 14 which was recorded up to Day 2, Day 8 and Day 15. Baseline was defined as the assessment on Day 1 pre-dose. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1, Day 7 and Day 14) values.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||L||Standard Error|Least Squares Mean
1268481|NCT00372112|Secondary|Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time|FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose and post-dose at Day 1, 2, 7, 8, 14 and 15. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h and maximum FEV1 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||L||Standard Deviation|Mean
1268482|NCT00372112|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time|FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose at Day 1, 2, 7, 8, 14 and 15. FEV1 was assessed post-dose at Day 1, 2, 7, 8 and 14. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Baseline was defined as the assessment done on pre-dose Day 1. The change from Baseline pre-dose was calculated by subtracting the Baseline value (pre-dose Day 1) from the individual post Baseline (Day 2, 7, 8, 14 and 15) values. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h change from Baseline was the AAUCMB obtained at Day 1, 2, 7, 8, 14 and 15. The maximum FEV1 0-4 h change from Baseline was obtained at Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||Litres (L)||Standard Deviation|Mean
1268483|NCT00372112|Secondary|Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14|The parameters of biochemistry with their normal range included: basophils (0-0.2 giga cells [GI]/L), eosinophils (0.05-0.55 GI/L), haematocrit (0.41-0.5 ratio), hemoglobin (138–172 g/L), lymphocytes (0.85-4.1 GI/L), mean corpuscle hemoglobin ([MCH] 27–33 picogram [pg]), mean corpuscle hemoglobin concentration ([MCHC] 320–360 g/L), mean corpuscle volume ([MCV] 80–100 femtoliter [fl]), monocytes (0.2-1.1 GI/L), segmented neutrophils (1.8–8 GI/L), total neutrophils (1.8–8 GI/L), platelet count (130–400 GI/L), red blood cell ([RBC] 4.4-5.8 trillion cells [TI]/L) count and white blood cell ([WBC] 3.8-10.8 GI/L) count. The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized.|Baseline (Day 1) up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1268493|NCT00372112|Secondary|Mean Hourly HR 0-24 h at Day 1, 7 and 14|HR was measured using 28.5 h ABPM. The assessments were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14.|Day 1 up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
1268702|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|Pre Intervention||||units on a scale||Standard Deviation|Mean
1269502|NCT00364130|Secondary|Change in Posteroanterior Lumbar Spine Areal BMD Z-score|We calculated the mean change in posterior anterior lumbar spine areal BMD Z-score between baseline and 12 months as measured by DXA|12 months||||Z-score||Standard Deviation|Mean
1268484|NCT00372112|Secondary|Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14|The parameters of biochemistry with their normal range included: alanine amino transferase ([ALT] 0-48 international units per liter [IU/L]), albumin (32-50 gram [g]/L), alkaline phosphatase ([ALP] 20-125 IU/L), aspartate amino transferase ([AST] 0-42 IU/L), calcium (2.12-2.56 millimole [mmol]/L, chloride (95-108 mmol/L), creatine kinase ([CK] 0-235 IU/L), creatinine (44-124 micromole [µmol]/L), direct bilirubin (0-6 µmol/L), gamma glutamyl transferase ([GGT] 0-65 IU/L), glucose (3.9-6.9 mmol/L), lactate dehydrogenase ([LDH] 0-250 IU/L), potassium (3.5-5.3 mmol/L), sodium (135-146 mmol/L), total bilirubin (0-22 µmol/L), total protein (60-85 g/L), urea (2.5-9 mmol/L) and uric acid (250-510 µmol/L). The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized.|Baseline (Day 1) up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1268485|NCT00372112|Secondary|Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time|A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the heart’s rhythm. The assessment for the events of supra ventricular ectopics, ventricular ectopics and ventricular runs per 24 h was done on Day 1, Day 7 and Day 14.|Day 1 up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Number of events||Standard Deviation|Mean
1268486|NCT00372112|Secondary|Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time|A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the ECG intervals. The assesmment for hourly maximums QTcF and QTcB was done on Day 1, Day 7 and Day 14. For each h of holter monitoring the maximum QTcF for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)^1/3. For each h of holter monitoring the maximum QTcB for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)^1/2.|Day 1 up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Mean
1268487|NCT00372112|Secondary|Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time|A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The pre-dose QTcF and QTcB assessment was done at Day 1, 7 and 14. Weighted mean at 0-4 h for QTcF and QTcB at Day 1, 2, 7, 8, 14 and 15 was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The maximum QTcF and QTcB at 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Mean
1268488|NCT00372112|Secondary|Change From Baseline in QTc by Federicia’s Method (F) and QTc Bazett’s Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time|A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The Baseline for pre-dose QTcF and QTcB measurements was the pre-dose assessment on Day 1. Weighted mean at 0-4 h for QTcF and QTcB was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB. The change from Baseline in maximum QTcF and QTcB at 0-4 h was calculated by subtracting the Baseline (pre-dose Day 1) value from the individual post-Baseline values.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||Millisecond (msec)||Standard Deviation|Mean
1268489|NCT00372112|Secondary|Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM|BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1268490|NCT00372112|Secondary|Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time|BP was measured using 28.5 h ABPM. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. For the calculation of 0-4 h maximum/minimum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1 for SBP and DBP. Maximum/minimum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1 for SBP and DBP) from the maximum/minimum assessment value (during 0-4 h) of the individual post-Baseline time points.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1268491|NCT00372112|Secondary|Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time|BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the weighted mean SBP and DBP on pre-dose Day 1. The weighted mean change from Baseline was the AAUCMB. Data is reported for change from Baseline in weighted mean pre-dose values at Day 7 and Day 14; change from Baseline in weighted mean over 0-4 h at Day 1, 2, 7, 8, 14 and 15; and change from Baseline in weighted mean over 0-24 h at Day 1, 7 and 14.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1268494|NCT00372112|Secondary|Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM|HR was measured using 28.5 h ABPM. Weighted mean HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Weighted mean HR at 0-24 h was obtained from measurements made 0-24 h post-dose on Day 1, 7 and 14. Maximum HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
1268495|NCT00372112|Secondary|Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15|HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). For the calculation of 0-4 h maximum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1. Maximum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1) from the maximum assessment value (during 0-4 h) of the individual post-Baseline time points.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Error|Least Squares Mean
1268496|NCT00372112|Secondary|Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14|HR was measured using 28.5 h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-24 h post-dose on Day 7 and 14, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
1268497|NCT00372112|Secondary|Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15|HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15 and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Error|Least Squares Mean
1268498|NCT00372112|Secondary|Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14|HR was measured using 28.5h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the area under curve (AUC) of measurements made pre-dose on each day, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the average AUC minus Baseline (AAUCMB).|Baseline (Day 1, pre-dose) up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
1268499|NCT00372112|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Follow-up (17 days)|Safety Population comprised of all participants who were randomized and received at least one dose of study medication.|||Participants|||Count of Participants
1268500|NCT00372060|Other Pre-specified|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52|Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.|Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.|The Completers Population (CP) includes all randomized patients who took at least 1 dose of sitagliptin and had [1] a baseline (Sitagliptin/Sitagliptin group) or Week 12 (Placebo/Sitagliptin group) value and [2] a value at Week 52.|||Percent||95% Confidence Interval|Mean
1268501|NCT00372060|Other Pre-specified|Change From Baseline in 2 Hour Postprandial Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 weeks|Analysis in the Full Analysis Set without Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline values.).|||mg/dL||95% Confidence Interval|Least Squares Mean
1268502|NCT00372060|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 Weeks|Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.)|||mg/dL||95% Confidence Interval|Least Squares Mean
1268503|NCT00372060|Primary|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 Weeks|Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.)|||Percent||95% Confidence Interval|Least Squares Mean
1268504|NCT00371865|Secondary|Pain Anxiety Symptom Scale - 20|This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
1268505|NCT00371865|Secondary|Beck Depression Inventory|This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
1268510|NCT00371826|Secondary|Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)|Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine.|Week 2, Month 24|Safety population extension (SAF-EX): All patients who entered the extension period, who were treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with week 2 and month 24 assessment for this analysis were included.|||g/cm^2||Standard Deviation|Mean
1268511|NCT00371826|Secondary|Number of Patient Survival and Graft Survival (36 Months Analysis)||At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268512|NCT00371826|Secondary|Number of Patient Survival and Graft Survival (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268513|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)|The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication|||Participants|||Number
1268514|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)|The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268515|NCT00371826|Secondary|Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)||At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268516|NCT00371826|Secondary|Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268517|NCT00371826|Secondary|Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)|"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L"|Overall Post Baseline up to month 36|Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with serum lipid assessment anytime post baseline up to 36 month were included .|||Participants|||Number
1268518|NCT00371826|Secondary|Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)|"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L"|Overall post baseline up to month 12|Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with serum lipid assessment anytime post baseline up to 12 month were included in this analysis.|||Participants|||Number
1268519|NCT00371826|Secondary|Number of Participants With Any Wound Problems (36 Months Analysis)|Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.|||Participants|||Number
1268520|NCT00371826|Secondary|Number of Participants With Wound Problems(12 Months Analysis)|Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268849|NCT00369941|Primary|Number of Participants That Discontinued With CAEs at Week 48|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268521|NCT00371826|Secondary|Number of Participants With Employment Status (36 Months Analysis)|"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other"|At screening (at day 0 +/- 7 days ), At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268522|NCT00371826|Secondary|Number of Participants With Employment Status (12 Months Analysis)|"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other"|At screening (at day 0 +/- 7 days ), At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268523|NCT00371826|Secondary|Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)|This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.|Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.|||Participants|||Number
1268524|NCT00371826|Secondary|Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)|This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.|Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268525|NCT00371826|Secondary|Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)|"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).~Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL."|At Month 24|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug. Patients with completed SF-36 assessment were included in this analysis.|||units on a scale||Standard Deviation|Mean
1268526|NCT00371826|Secondary|Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)|"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).~Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Only those patients who had completed the QoL assessment for Month 12 were included in this analysis.|||units on a scale||Standard Deviation|Mean
1268527|NCT00371826|Secondary|Number of Participants With Erythropoietin Usage (36 Months Analysis)||Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.|||participants|||Number
1268528|NCT00371826|Secondary|Number of Participants With Erythropoietin Usage (12 Months Analysis)||Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||participants|||Number
1268529|NCT00371826|Secondary|Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)|"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline"|Baseline, Overall post baseline up to Month 36|Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with baseline and overall post baseline up to month 36 assessment were included.|||Participants|||Number
1268530|NCT00371826|Secondary|Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)|"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline"|Baseline, Overall post-baseline up to 12 month|Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with baseline and overall post baseline up to 12 month assessment for this analysis were included.|||Participants|||Number
1268850|NCT00369941|Primary|Number of Participants That Died by Week 48|All participant deaths in the span of 48 weeks on study were recorded.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268531|NCT00371826|Secondary|Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)|"The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL~Diabetes reported as treatment emergent AE with end date > Day 15"|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.|||Participants|||Number
1268532|NCT00371826|Secondary|Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)|"The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions~Hemoglobin subtype A1c (HbA1c) > 6.5%~Diabetes reported as treatment emergent AE with end date > Day 15"|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on PTDM were included in this analysis.|||Participants|||Number
1268533|NCT00371826|Secondary|Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)|Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.|At Month 12, 18, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment in extension period. This also includes all patients who were randomized but were not treated with study medication. Patients with ACR data at particular time point were included for analysis.|||mg/mmol||Standard Deviation|Mean
1268534|NCT00371826|Secondary|Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)|Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on Proteinuria were included in this analysis.|||mg/mg||Standard Deviation|Mean
1268535|NCT00371826|Secondary|Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)|"Creatinine clearance were calculated according to the Cockcroft-Gault formula:~CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].~The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age."|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine clearance were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.|||mL/min||Standard Deviation|Mean
1268536|NCT00371826|Secondary|Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)|"Creatinine clearance were calculated according to the Cockcroft-Gault formula:~CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].~The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on creatinine clearance were included in this analysis.|||mL/min||Standard Deviation|Mean
1268537|NCT00371826|Secondary|Mean Serum Creatinine (36 Months Analysis)||At Month 12, 18, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine serum creatinine were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.|||umol/L||Standard Deviation|Mean
1268538|NCT00371826|Secondary|Mean Serum Creatinine (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on serum creatinine were included in this analysis.|||umol/L||Standard Deviation|Mean
1268539|NCT00371826|Secondary|Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)|"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)."|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.|||Participants|||Number
1268548|NCT00371826|Primary|Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)|The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.|At Month 12|Modified intent-to-treat (mITT)-Add population: All ITT patients who had a calculated GFR value recorded at Month 12 post-randomization including those collected after discontinuation of study medication and retrospectively collected creatinine and urea data|||mL/min per 1.73 m^2||Standard Deviation|Mean
1268540|NCT00371826|Secondary|Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)|"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with “transmural” arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.|||Participants|||Number
1268541|NCT00371826|Secondary|Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)|"Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done."|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data available at month 36 were included in this analysis.|||Participants|||Number
1268542|NCT00371826|Secondary|Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)|"A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.|||Participants|||Number
1268543|NCT00371826|Secondary|Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)|"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss."|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268544|NCT00371826|Secondary|Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)|"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss."|Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268545|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)|A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268546|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)|A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
1268547|NCT00371826|Secondary|Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)|The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.|At Month 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Missing values were imputed by last observation carried forward (LOCF) using values beyond Month 6|||mL/min per 1.73 m^2||Standard Error|Mean
1268549|NCT00371787|Primary|Neovascularization|length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.|9 month||||mm||Standard Deviation|Mean
1268550|NCT00371787|Primary|Neovascularisation|length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.|baseline||||mm||Standard Deviation|Mean
1268553|NCT00371761|Primary|Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response|"Serological response is defined as Loss of HBeAg (Hepatitis B e antigen) and Appearance of anti-HBe (Hepatitis B e antibodies); participant is HBeAg negative and anti-HBe positive.~Virological response was defined as having < 10^5 copies/mL of serum HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) by real-time PCR (Polymerase Chain Reaction).~Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L."|At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks]||||Participants|||Number
1268554|NCT00371683|Secondary|Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or <LLN. Total Protein: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.|||participants|||Number
1268555|NCT00371683|Secondary|Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period|Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.|||participants|||Number
1268556|NCT00371683|Secondary|Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.|||participants|||Number
1268557|NCT00371683|Secondary|Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.|||participants|||Number
1268558|NCT00371683|Secondary|Mean Change From Baseline in Heart Rate During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm).|Baseline to last dose of study drug, plus 2 days|All participants who received at least one dose of study drug and had heart rate measurements at baseline were summarized.|||bpm||Standard Error|Mean
1268559|NCT00371683|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg).|Baseline to last dose of study drug, plus 2 days|All participants who received at least one dose of study drug and had blood pressure measurements at baseline were summarized.|||mmHg||Standard Error|Mean
1268560|NCT00371683|Secondary|Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)|All participants who received at least 1 dose of study drug during the Treatment Period.|||participants|||Number
1269978|NCT00360334|Secondary|Change in 7 Point Self Monitored Blood Glucose Profile|Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Deviation|Mean
1268561|NCT00371683|Secondary|Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period|A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients.|Post last dose of study drug to Day 72 (60 days)|Participants who received at least one dose of study drug and entered the Follow-Up period|||percentage of participants||95% Confidence Interval|Number
1268562|NCT00371683|Primary|Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period|ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72.|Last dose of study drug to Day 72 (60 days)|All participants who received at least 1 dose of study drug during the Treatment Period and entered the Follow-Up Period.|||percentage of participants||95% Confidence Interval|Number
1268563|NCT00371683|Primary|Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population|ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days.|First dose of study drug to last dose, plus 2 days post last dose|All participants who received at least one dose of study drug (Treated population).|||percentage of participants||95% Confidence Interval|Number
1268564|NCT00371683|Secondary|Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period|ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From first dose to last dose, plus 2 days (12 days, plus 2)|All participants who received at least one dose of study drug were analyzed (Treated Population).|||percentage of participants||95% Confidence Interval|Number
1268565|NCT00371683|Secondary|Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period|ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal (or distal, as appropriate) venogram or an adjudicated event associated with the endpoint. n= number analyzed|||percentage of participants||95% Confidence Interval|Number
1268566|NCT00371683|Secondary|Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period|An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants: PE, Symptomatic DVT, Symptomatic Proximal DVT, Symptomatic Distal DVT. Randomized with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint: All DVT, Asymptomatic DVT. n=number analyzed in each category|||percentage of participants||95% Confidence Interval|Number
1268567|NCT00371683|Secondary|Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268568|NCT00371683|Secondary|Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268569|NCT00371683|Secondary|Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268570|NCT00371683|Secondary|Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268571|NCT00371683|Secondary|Event Rate for Participants With All-Cause Death During the Intended Treatment Period|Event rate was number of participants with all-cause death divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All Randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268572|NCT00371683|Secondary|Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268573|NCT00371683|Secondary|Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268574|NCT00371683|Secondary|Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period|An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268575|NCT00371683|Secondary|Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period|VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268576|NCT00371683|Secondary|Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period|A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated non-fatal PE or death, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
1268577|NCT00371683|Primary|Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects|An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization.|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Primary Population=All randomized participants who: have an adjudicated and evaluable bilateral venogram performed during the Intended Treatment Period; or have an adjudicated VTE during the Intended Treatment Period; or die due to any cause during the Intended Treatment Period.|||percentage of participants||95% Confidence Interval|Number
1268578|NCT00371644|Primary|PTSD Checklist (PCL)|The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.|Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment|Numbers differ from enrollment due to participants excluded from data analysis for poor psychotherapeutic fidelity.|||units on a scale||Standard Error|Mean
1268579|NCT00371631|Secondary|The Rate of Symptomatic UTI While Colonized|Symptomatic UTI was defined as significant bacteriuria (≥105 cfu/ml) and pyuria (>10 WBC/hpf) plus ≥1 of the following signs and symptoms for which no other etiology could be identified: fever (oral temperature >100°F), suprapubic or flank discomfort, bladder spasm, change in voiding habits, increased spasticity, or worsening dysreflexia. The rate of UTI (number) was calculated by dividing the total number of patient days by the total number of UTIs.|3 years||||UTI/per subject year|||Number
1268580|NCT00371631|Primary|Bladder Colonization|Bladder colonization was defined when (≥102 cfu/ml) of E. coli 83972 was detected in urine cultures for > 3 days after catheter removal.|> 3 days, up to 197 days||||percentage of participants|||Number
1268596|NCT00371566|Secondary|Summary of Serious Adverse Events During or After Chemoradiotherapy Phase|Events which started during or After Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
1268581|NCT00371566|Secondary|Relative Change From Baseline of Kep Median (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268582|NCT00371566|Secondary|Relative Change From Baseline of Whole IAUC(90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268583|NCT00371566|Secondary|Relative Change From Baseline of Perfused IAUC (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268584|NCT00371566|Secondary|Relative Change From Baseline of IAUC Mean (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268585|NCT00371566|Secondary|Relative Change From Baseline of IAUC Median (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268586|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Whole (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268587|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Perfused (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268729|NCT00370682|Secondary|Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines|"Percentage of subject with Tetravalent responses for neutralizing antibodies, according to pre-vaccination dengue immune status. There was no placebo run for DEN Monovalent.~PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7"|post dose 1 and 2||||% of subjects||95% Confidence Interval|Number
1268588|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Mean (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268589|NCT00371566|Secondary|Relative Change From Baseline of Kep Whole (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268590|NCT00371566|Secondary|Relative Change From Baseline of Kep Perfused (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268591|NCT00371566|Secondary|Relative Change From Baseline of Kep Mean (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268592|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Median (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
1268593|NCT00371566|Secondary|Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 5 are death related to Adverse Event."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
1268594|NCT00371566|Secondary|Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 4 are life-threatening or disabling Adverse Event (complicated by acute, life-threatening metabolic or cardiovascular complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation)."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
1268595|NCT00371566|Secondary|Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 3 are severe and undesirable Adverse Event (significant symptoms requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation)."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
1268639|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR|VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.|At Baseline and Week 5 of treatment|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis|||percent change||90% Confidence Interval|Mean
1268597|NCT00371566|Secondary|Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase|Events which started during or After the Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
1268598|NCT00371566|Secondary|Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group|Definition of an adverse event is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 1 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
1268599|NCT00371566|Secondary|Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information|Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.|weeks 19 - 25|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
1268600|NCT00371566|Secondary|Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information|Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.|Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
1268601|NCT00371566|Secondary|Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase|Toxicity Grading scale 0=none, 1= transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.|Week 10 through 25|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Participants|||Number
1268602|NCT00371566|Secondary|Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase|Toxicity Grading scale 0=none, 1=transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.|Week 1 through Week 6|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Participants|||Number
1268603|NCT00371566|Secondary|Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase|"Tumor Suppressor p53 is welcomed and described as the guardian angel gene, it conserves stability by preventing genome mutation. Human Papillomavirus (HPV) biomarker is un-welcomed and is found to be an important precursor cancers of the head and neck. HPV biomarkers have the ability to bind to and inactivate the Tumor Suppressor p53 biomarker."|Week 2|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
1268604|NCT00371566|Secondary|Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase|Estrogen Receptor (ER) variants, ERB-B2 and ERB B-5 consist of the major proportion of ER expression both in normal and cancer tissues. The exact role of these markers are unknown. Acronyms defined: ICH (immunohistochemical) and FISH (fluorescence in situ hybridization).|Baseline and Week 2|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
1268605|NCT00371566|Secondary|Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's) after chemoradiotherapy numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|End of Chemoradiotherapy (week 10 - 13)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
1268606|NCT00371566|Secondary|Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's) after treatment numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|End of Treatment (week 2 - 6)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
1268607|NCT00371566|Secondary|Number of Circulating Tumor Cells at Baseline in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's)Pre-Treatment numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|Baseline|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. mITT FOLLOW-UP Population of Circulation Tumor Cells|||Participants|||Number
1268608|NCT00371566|Secondary|Overall Radiological Response After Follow-up Phase in ITT Population|Over all: Complete Response (CR) – absence of lesions. Partial Response (PR) - CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)– no PD or Response. Progressive Disease (PD)– PD or new lesions. Not Evaluable(NE)– no other definitions.|Baseline and End of Follow-up (week 19 - 25)|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Participants|||Number
1268609|NCT00371566|Secondary|Overall Radiological Response After Treatment Phase in ITT Population|Over all: Complete Response (CR)–absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)–no PD or Response. Progressive Disease (PD)–PD or new lesions. Not Evaluable(NE)– no other definitions.|Baseline and End of Treatment (Week 2 - 6)|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Participants|||Number
1268610|NCT00371566|Secondary|Overall Radiological Response After Follow-up Phase in mITT Population|Over all: Complete Response(CR)–absence of lesions. Partial Response(PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD)in other lesions with no new lesions or progressive disease (PD). Stable Disease(SD)–no PD or Response. Progressive Disease(PD)–PD or new lesions. Not Evaluable(NE)– no other definitions. Number of subjects included those who were considered evaluable if they completed a full course of chemoradiotherapy and were able to provide a baseline and follow-up scan following the completion of chemoradiation.|Baseline and End of Follow-up (Week 19 - 25)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
1268611|NCT00371566|Secondary|Overall Radiological Response After Treatment Phase in mITT Population|Over all: Complete Response (CR)– absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)–no PD or Response. Progressive Disease (PD)–PD or new lesions. Not Evaluable(NE)– no other definitions. Number of subjects included those who had a scan immediately post lapatanib/placebo monotherapy.|Baseline and End of Treatment (Week 2 - 6)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
1268612|NCT00371566|Secondary|Change From Baseline of Cell Proliferation Rate of the Ki-67 Proliferative Index in Tumour Biopsy Samples During Treatment Phase|The Ki-67 protein is expressed in all phases of the cell cycle except G0 (low level phase) and serves as a good marker for cell proliferation. Scoring is assessed by point counting 500 to 1000 cells, and is reported as percent positive cells. 20% positive cells to define “positive” (i.e. high risk)|Baseline and Week 2|The mITT (modified Intent-to-Treat) population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumor biopsy sample for the primary endpoint analysis.|||Percent of positive cells||Standard Deviation|Mean
1268613|NCT00371566|Primary|Change From Baseline of the Apoptotic Index During Treatment Phase|Apoptotic Index-TUNEL Assay is a method which counts a total of at least 1000 neoplastic nuclei(Cells with morphological changes defining cell death) subdivided in 10 fields chosen randomly at 400x magnification. A ‘responder’ was defined as having 20% cell death.|Baseline and Week 2|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Percentage of positive cells||Standard Deviation|Mean
1268614|NCT00371540|Secondary|Death||12 months||||participants|||Number
1268615|NCT00371540|Primary|Lost to Follow-up|Number of Subjects Lost to follow-up|12 months||||participants|||Number
1268616|NCT00371540|Secondary|Viral Load|Detectable VL at 12 months|12 months||||participants|||Number
1268617|NCT00371462|Primary|Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I)|Study was terminated by VA. No VA outcome data to report.|baseline, 3, 6, 9, and 12 months|No data were analyzed due to termination of the study.||||||
1268618|NCT00371449|Secondary|Speech Spatial and Qualities of Hearing Scale (SSQ)|The SSQ measures hearing abilities related to speech, spatial perception, and quality of sound using a 1-10 scale. Items are averaged across the test. Higher scores indicate better outcomes.|aided (after wearing hearing aids for at least 3 months)||||units on a scale (points)||Standard Deviation|Mean
1268619|NCT00371449|Secondary|Satisfaction With Amplification in Daily Life (SADL)|Measures how satisfied listeners are with their current hearing aids. Total scale scores are computed by averaging the subscale (positive effect, negative features, personal image, and service & delivery) scores that range from 1 (no satisfaction) to 7 (high satisfaction).|aided (after wearing hearing aids for at least 3 months)||||units on a scale (points)||Standard Deviation|Mean
1268620|NCT00371449|Secondary|Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)|Measures hearing-aid self-efficacy over four subscales (basic handling, advanced handling, adjustment, and aided listening). Subscale scores are averaged to produce a total self-efficacy scores that can range from 0 (low self-efficacy) to 100 (high self-efficacy).|aided (after wearing hearing aids for at least 3 months)||||% level of self-efficacy||Standard Deviation|Mean
1268621|NCT00371449|Secondary|International Outcomes Inventory for Hearing Aids (IOI-HA)|Overall/general hearing-aid outcome measure. Range in scores are 7-35 with higher scores representing better outcomes.|aided (after wearing hearing aids for at least 3 months)||||units on a scale (points)||Standard Deviation|Mean
1268650|NCT00371345|Secondary|Duration Of Objective Response|Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment.|the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed|Of 69 response-evaluable participants, three had an objective response of PR.|||weeks|||Number
1268622|NCT00371449|Secondary|Acceptable Noise Level Test|"The ANL consists of a speech signal and a competing noise signal. The speech signal is a continuous monologue (Arizona Travelogue) by a male talker and the competing noise signal is the 12-talker babble from the Speech in Noise (SPIN) test (Kalikow et al, 1977). The speech and babble stimuli are recorded on separate channels on a compact disc (CD; Cosmos, Inc.). The task of the listener was to adjust the level of the travelogue to the most comfortable level (MCL) and then to adjust the level of the babble to the level the listener is willing to put up with and still follow the travelogue, or to the background noise level (BNL). The ANL (in dB) is the difference between the MCL and BNL."|aided (after wearing hearing aids for at least 3 months)||||dB||Standard Deviation|Mean
1268623|NCT00371449|Primary|Words-in-noise Test|The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.|aided (after wearing hearing aids for at least 3 months)||||dB S/N||Standard Deviation|Mean
1268624|NCT00371436|Primary|THI (Tinnitus Handicap Inventory)|The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap.|Baseline, 6 months|The THI was completed by 58 of the 92 PATM patients at both baseline and 6 months. The THI was completed by 68 of the 89 Usual Care patients at both baseline and 6 months.|||scores on a scale||Standard Deviation|Mean
1268625|NCT00371397|Secondary|Mood: Positive and Negative Affect Schedule (PANAS)Negative|The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.|7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart|||||||
1268626|NCT00371397|Secondary|Mood: Positive and Negative Affect Schedule (PANAS)Positive|The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.|7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart|||||||
1268627|NCT00371397|Secondary|Blood Pressure||7:55 at each of the three visits, scheduled at least 2 weeks apart|||||||
1268628|NCT00371397|Secondary|Heart Rate||Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15|||||||
1268629|NCT00371397|Primary|Catecholamine Production: Norepinephrine|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|8:30, 10:05, 10:28, 10:58, 11:35, 12:05|||||||
1268630|NCT00371397|Primary|Catecholamine Production: Epinephrine|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart|||||||
1268631|NCT00371397|Primary|Immune Function: Interleukin-6 (IL-6)|Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions|Day 1 8:30, 11:35, 13:10. Day 2 7:30|||||||
1268632|NCT00371397|Primary|Immune Function: LPS-stimulated Production of TNF-α|Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).|Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30|||||||
1268633|NCT00371397|Primary|Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)|Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).|Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30|||||||
1268634|NCT00371397|Primary|Immune Function: Tumor Necrosis Factor-alpha (TNF-α)|Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.|Day 1 8:30, 11:35, 13:10. Day 2 7:30|||||||
1268635|NCT00371397|Primary|Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)|Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.|Day 1 8:30, 11:35, 13:10. Day 2 7:30|||||||
1268636|NCT00371397|Primary|Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)|Cellophane tape stripping, a common dermatological paradigm for studying restoration of the skin barrier, was used to examine whether the time necessary for recovery from minor physical insults varied by condition or yoga expertise. Measurement of the rate of transepidermal water loss (TEWL) through human skin provides a noninvasive method to monitor changes in the skin’s barrier function. TEWL was measured twice during the session using a computerized evaporimetry instrument, the DermaLab® (CyberDERM, Media, PA), and barrier recovery was calculated.|11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart|||||||
1268637|NCT00371397|Primary|Cortisol|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30|||||||
1268638|NCT00371397|Primary|Number of Participants With Detectable C-Reactive Protein (CRP)|High sensitivity C-reactive protein (hsCRP) assessed once at baseline, at each of the three visits. The hsCRP assay was performed using chemiluminescence methodology with the Immulite 1000 (Siemens Medical Solutions, Los Angeles, Ca.) The lowest level of detection is .3 mg/dL. 43% of the values were below this lower bound, thus hsCRP was dichotomized as undetectable/detectable.|8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart||||participants with CRP above 0.3|||Number
1268730|NCT00370682|Secondary|Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period.|Number of subjects with incidence of suspected and confirmed dengue throughout the entire study period.|9 months||||Participants|||Count of Participants
1268640|NCT00371345|Primary|Best Overall Response|Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.|From day of first treatment through Week 25 or at time of discontinuation from study treatment|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||participants|||Number
1268641|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR|VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.|At Baseline and Week 3 of treatment (Day 15 ±4 days)|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis|||percent change||90% Confidence Interval|Mean
1268642|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR|Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.|Week 5|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis|||percent change||90% Confidence Interval|Mean
1268643|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR|Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.|At Baseline and Week 3 of treatment (Day 15 ±4 days)|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis|||percent change||90% Confidence Interval|Mean
1268644|NCT00371345|Secondary|PK: Plasma Concentration of Dasatinib at Week 7 or Week 9|Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.|PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).|Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis|||ng/ml||Standard Deviation|Mean
1268645|NCT00371345|Secondary|Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3|Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.|PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).|Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis|||ng/ml||Standard Deviation|Mean
1268646|NCT00371345|Secondary|Number Of Participants With Notable Drug-related AEs|Notable drug-related AEs for dasatinib include gastrointestinal symptoms (diarrhea, nausea, vomiting and abdominal pain), fatigue, lethargy, headache, rash, fever, pleural effusion, and dyspnea.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.|||participants|||Number
1268647|NCT00371345|Secondary|Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to CTCAE Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.|||participants|||Number
1268648|NCT00371345|Secondary|Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities|Normal ranges for laboratory abnormalities: granulocytes=1.5x10^3-8x10^3 mm^3 (range may have varied by institution); hemoglobin=12-16 g/dL; platelets=150-440x10^9c/L; partial thromboplastin time=27-37.1 seconds; alkaline phosphatase=38-126 U/L; alanine aminotransferase=15-48 U/L; aspartate aminotransferase=14-38 U/L; creatine=0.7-1.1 mg/dL; hypokalemia (potassium [K])=3.5-5mEq/L; hyponatremia (sodium [Na])=135-145 mEq/L; phosphorous=2.4-4.5 mg/dL; bilirubin=0-1.2. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening/disabling, Gr 5=Death.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.|||participants|||Number
1268649|NCT00371345|Secondary|Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.|||participants|||Number
1268651|NCT00371345|Secondary|Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25|PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed.|At Weeks 9, 17, and 25|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||percentage of participants|||Number
1268652|NCT00371345|Secondary|Median Progression Free Survival (PFS)|PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed.|From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)|All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks.|||weeks||95% Confidence Interval|Median
1268653|NCT00371345|Secondary|Number of Participants Who Progressed|PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed.|From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)|All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks.|||participants|||Number
1268654|NCT00371345|Secondary|Percentage of Response-evaluable Participants With Disease Control (DCR)|Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||percentage of participants||95% Confidence Interval|Mean
1268655|NCT00371345|Secondary|Number of Response-evaluable Participants With Disease Control (DCR)|Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||participants|||Number
1268656|NCT00371345|Primary|Percentage of Participants With Objective Response|Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|From day of first treatment through Week 25 or at time of discontinuation from study treatment|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||percentage of participants||95% Confidence Interval|Number
1268657|NCT00371345|Primary|Number of Participants With Objective Response|Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment. One participant was not evaluable (no on-study tumor assessment for other reason).|||participants|||Number
1268658|NCT00371293|Secondary|Change in HDL Cholesterol Levels||Measured at Baseline and Week 24||||mg/dL||95% Confidence Interval|Mean
1268659|NCT00371293|Secondary|Change in Triglyceride Levels||Measured at Baseline and Week 24||||mg/dL||95% Confidence Interval|Mean
1268660|NCT00371293|Secondary|Change in LDL Cholesterol Levels||Measured at Baseline and Week 24||||mg/dL||95% Confidence Interval|Mean
1268661|NCT00371293|Secondary|Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min−1/μU/ml)|Assessed using the frequently sampled intravenous glucose tolerance test (FSIGTT) which evaluates blood glucose and insulin levels. Insulin sensitivity is estimated using the Bergman’s minimal model.|Measured at Baseline and Week 24||||x10-4/min−1/μU/ml||95% Confidence Interval|Mean
1268662|NCT00371293|Primary|Inflammation||Measured at Baseline and Week 24||||percentage of change in crp at week 24||95% Confidence Interval|Mean
1268663|NCT00371267|Secondary|Pain Intensity Rating|Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1268664|NCT00371267|Secondary|Pain Behavior Checklist Total Score|Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1268665|NCT00371267|Primary|Short Form-12 Mental Health|Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1268666|NCT00371267|Secondary|Beck Depression Inventory (BDI)-2 Total Score|Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1268667|NCT00371267|Primary|Short Form-12 Physical Health|Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1268668|NCT00371254|Secondary|Number of Participants With Abnormal Vital Signs Measurements|Vital signs included systolic and diastolic blood pressure and heart rate. The investigator used his or her judgement to decide whether or not the values were abnormal.|At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks)|All treated participants|||participants|||Number
1268669|NCT00371254|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECGs were performed and all recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed. The following ECG variables were collected: heart rate, PR interval, QRS width, and QT interval. Abnormalities in ECGs were defined by reference to institutional reports.|Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).|All treated participants|||participants|||Number
1268670|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total).|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Creatinine: Grade 3-4 : > 3.0 -6.0 ULN (upper limit of normal),Bicarbonate: Grade 3-4: <16 -<22 mEq/L, Phosphorous: Grade 3-4 : <1.0 - <2.0 mg/dL, Bilirubin, total: Grade 3-4: >3.0 - >10.0 ULN.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
1268671|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Calcium: Grade 3-4 : <6.0 – <7.0 or >12.5 – >13.5 mg/dL, Potassium: Grade 3-4 : <2.5 – <3.0 or >6.0 – >7.0 mEq/L, Magnesium: Grade 3-4 : <0.6 - <0.8 or >2.46 - >6.6 mEq/L, Sodium:< 120– 130 or >155 – >160 mEq/L.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
1268672|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: ALT, AST and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
1268673|NCT00371254|Secondary|Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT)|PTT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants.|||Participants|||Number
1268674|NCT00371254|Secondary|Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT)|PT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
1268675|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grades 3 and 4 criteria are defined as follows: Granulocytes: Grade 3 <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Hemoglobin: Grade 3, <8.0 - 6.5 g/dL; Grade 4, <6.5 g/dL. Platelets: Grade 3, <50.0 - 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Leukocytes: Grade 3, <2.0 - 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
1268676|NCT00371254|Secondary|Most Frequent Drug-related Adverse Events (AEs)|Most frequent drug-related AEs are those AEs with frequency >=25% in either group. Drug-related AEs are those events with relationship to study therapy of certain, probable or possible.|From start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
1268677|NCT00371254|Secondary|Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs|AE=any new untoward medical occurrence/worsening of pre-existing medical condition.SAE=AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event. Drug-related SAEs or AEs are those events with relationship to study therapy of certain, probable or possible.AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), v3: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.Participants who discontinued the study due to any drug-related AEs were also recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
1268678|NCT00371254|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.|||participants|||Number
1268679|NCT00371254|Secondary|Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity|Pharmacogenomic analysis included the assessment of the relationship between clinical benefit and mRNA expression levels and between clinical benefit and protein phosphorylation. Tumor mRNA expression was analyzed in all available tissues. mRNA was extracted from 96 formalin-fixed paraffin-embedded tissue (FFPET) samples, amplified, and fluorescently labeled. Gene expression profiling was conducted using Affymetrix Human Genome U133A 2.0 DNA microarrays. mRNA expression is reported as quantile normalized RMA values.|Baseline|All treated participants who were evaluable for the analysis. These data for pharmacogenomic analyses were integrated with those from other studies and are not reportable for this study alone.|||log2 scale (unitless)|||Number
1268680|NCT00371254|Secondary|Percentage Change in Tumor Biomarkers|Tumor markers are indicators of tumor activity which may be used to predict clinical benefit and circulating biomarkers may reveal key mechanisms of action. Tissue staining was performed for caveolin, phospho-caveolin, EphA2 and insulin-like growth factor binding protein 2 (IGFBP2) markers using immunohistochemistry assays.|Baseline|All treated participants who were evaluable for the analysis. These data for tumor markers were integrated with those from other studies and are not reportable for this study alone.|||percentage||Inter-Quartile Range|Median
1268681|NCT00371254|Secondary|Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline|VEGFR2 is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of VEGFR2 were obtained and analyzed by enzyme-linked immunosorbent assay.|Baseline, Week 3 and Week 5|Participants who were evaluable for pharmacodynamic analysis.|||percentage of baseline||90% Confidence Interval|Geometric Mean
1268684|NCT00371254|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|The percentage of participants whose best response was CR or PR, per the RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.|Baseline to end of study drug therapy (up to 65 weeks).|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug were included in this dataset.|||percentage of participants||95% Confidence Interval|Number
1268685|NCT00371254|Secondary|Mean Plasma Concentration at Week 3|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose and 1, 3, 6 and 12 hours after each dose administration|"Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point."|||nanograms (ng)/mL||Standard Deviation|Mean
1268686|NCT00371254|Secondary|Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)|Mean number of weeks of CR/PR (time from first date of CR/PR until first date PD observed. Tumor response defined per RECIST: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in sum of LDs of target lesions relative to baseline sum LD; PD: appearance of new lesion or >=20% increase in sum of LD of target lesions relative to smallest sum LD or unequivocal progression of existing non-target lesions. Participants who died without reported PD were considered to have PD on date of death. For participants who neither progressed nor died, date of last tumor assessment used.|Baseline to end of study drug therapy (up to 53.86 weeks)|Response-evaluable participants who achieved a complete response (CR) or partial response (PR)|||weeks||Full Range|Mean
1268687|NCT00371254|Secondary|Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25|PFS:time from first dose until the date that progressive disease (PD) or clinical PD (cPD) observed,per RECIST criteria.PD:appearance of new lesion/s,or >=20% increase in the sum of the LD of target lesions,relative to smallest sum LD recorded since treatment start,or unequivocal progression of existing non-target lesions;cPD:deterioration related to disease requiring treatment discontinuation,but without radiographic PD.Participants who died without PD were considered to have PD on the date of death.For participants who neither progressed nor died,date of the last tumor assessment was used.|Weeks 9, 17, and 25|All treated participants|||Proportion of Participants|||Number
1268688|NCT00371254|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study|The percentage of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Baseline to 16 weeks|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.|||percentage of participants||95% Confidence Interval|Number
1268689|NCT00371254|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study|The number of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Baseline to 16 weeks.|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.|||Participants|||Number
1268690|NCT00371254|Primary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.|Baseline to end of study drug therapy (up to 65 weeks).|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.|||participants|||Number
1268691|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|6 month follow-up||||units on a scale||Standard Deviation|Mean
1268692|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|3 month follow-up||||units on a scale||Standard Deviation|Mean
1268693|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|Post intervention||||units on a scale||Standard Deviation|Mean
1268694|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|Pre intervention||||units on a scale||Standard Deviation|Mean
1268695|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|6 month follow-up||||units on a scale||Standard Deviation|Mean
1268696|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|3 month follow-up||||units on a scale||Standard Deviation|Mean
1268697|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|6 month follow-up||||units on a scale||Standard Deviation|Mean
1268703|NCT00371150|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry|The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:>1.25xULN, Aspartate aminotransferase:>1.25xULN, Alkaline Phosphatase:>1.25xULN, Total Bilirubin:>1.1xULN, Serum Lipase:>1.10xULN, Creatinine:>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L|OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up|All treated participants. n = number of participants in the OF period.|||participants|||Number
1268704|NCT00371150|Primary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately <300 copies/mL.|Week 48 of ETV treatment|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||percentage of participants||95% Confidence Interval|Number
1268705|NCT00371150|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology|Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.|OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up|All treated participants. n = number of participants in the OF period.|||participants|||Number
1268706|NCT00371150|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From enrollment through Week 52 + 5 days|All treated participants.|||participants|||Number
1268707|NCT00371150|Secondary|Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis||Week 48|Since there were no other cut-off points other than those at the time of data analysis, this outcome was not analysed.|||percentage of participants|||Number
1268708|NCT00371150|Secondary|Mean log10 Reduction From Baseline in HBV DNA at Week 48|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.|baseline, Week 48|All treated participants. The participants who discontinued prior to Week 48 were counted as failure.|||log10 IU/mL||Standard Error|Mean
1268709|NCT00371150|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 48|All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||percentage of participants|||Number
1268710|NCT00371150|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 48|All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||percentage of participants|||Number
1268711|NCT00371150|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 48|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||percentage of participants|||Number
1268712|NCT00371150|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 48|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||percentage of participants|||Number
1268713|NCT00371150|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||percentage of participants|||Number
1268714|NCT00371150|Secondary|Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV|Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant’s nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)|through Week 48|All treated participants. The participants who discontinued prior to Week 48 were counted as failure.|||percentage of participants|||Number
1268715|NCT00371150|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||percentage of participants|||Number
1268716|NCT00371150|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||percentage of participants||95% Confidence Interval|Number
1277812|NCT00291551|Secondary|Change in Left Ventricular Ejection Fraction|Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol|||Percentage||Standard Deviation|Mean
1268717|NCT00371137|Primary|Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).|Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.|Baseline to Week 14||||Percentage of Participants|||Number
1268718|NCT00370994|Secondary|Functional Status|Oswestry Disability Index (ODI) – ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms.|3, 6, 12, 18 and 24 months post treatment.||||units on a scale||Standard Deviation|Mean
1268719|NCT00370994|Primary|Numeric Pain Rating Score|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable|3, 6, 12, 18 and 24 months post treatment.|Sample size is calculated based on reduction of NRS. A 25% clinical difference change of 1.15.|||units on a scale||Standard Deviation|Mean
1268720|NCT00370838|Primary|Total Tic Score|The TTS is a portion of the YGTSS [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). A score of 0 represent no tics present, a score of 50 represents the most severe tics in each category listed.|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
1268721|NCT00370838|Secondary|Modified Pittsburgh Side Effect Scale|"Side effects will be assessed by an expanded (modified) Pittsburgh Side Effect Scale modified to include side effects of levetiracetam and clonidine. Significant adverse events will be reported to the UCB, JCCI, and FDA within 24 hours. Positive responses are tallied as number of side effects for the responding period."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||Number of Side Effects||Standard Deviation|Mean
1268722|NCT00370838|Secondary|Multidimensional Anxiety Scale for Children (MASC):|"The child's anxiety will be followed using the multidimensional Anxiety Scale for Children (MASC) (Stallings and March, 1995) and is now considered the preferred instrument for rating childhood anxiety. It is a 39-item questionnaire, ranking each item as Never, Rarely, Sometimes, or Often (0, 1, 2, 3). The sum of all responses yeilds a score (maximum MASC score is 117). A score of 0 represents no anxiety, and a score of 117 represents severe anxiety."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
1268723|NCT00370838|Secondary|DuPaul Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale:|The presence of Attention Deficit Hyperactivity Disorder (ADHD) symptoms are assessed using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) version of the DuPaul ADHD rating scale, which incorporates the symptom items for ADHD from the DSM into a rating scale format that quantifies symptom severity. Each item is rated as not at all, just a little, pretty much, and very much (0, 1, 2, and 3). There are 18 items in total are summed, with a minimum score of 0 (meaning no inattention or hyperactivity) with a maximum score of 54 (severe inattention and hyperactivity).|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
1268724|NCT00370838|Secondary|Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS):|The severity of obsessive-compulsive disorder (OCD) is evaluated using the CY-BOCS [Scahill et al 1997]. Obsessions and compulsions are rated on 5 separate scales yielding three summary scores: Obsessions (0-20), Compulsions (0-20) and Total score (0-40). The CY-BOCS is the most widely used instrument to assess the severity of OCD symptoms in research studies. It includes checklist of specific obsessions and compulsions followed by examiner ratings of time spent, interference, distress, resistance and control over the obsessions and compulsions.0=no obsessions or compulsions; 40=most severe OC|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
1268725|NCT00370838|Secondary|Clinical Global Impression-Improvement (CGI-I):|"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to very much improved; 2 equals much improved; 3 denotes minimal change; and 4 represents no change. Scores above 4 are used to indicate deterioration, i.e., 5 equals minimally worse; 6 is much worse; and 7 is very much worse."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
1268726|NCT00370838|Primary|Yale Global Tic Severity Scale (YGTSS):|The YGTSS is a semi-structured clinical interview designed to measure current tic severity [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). The YGTSS contains an impairment ranking, 0-50 points, based on the impact of the tic disorder on areas such as self esteem, family life, social acceptance, and school. 0=no tics present; 100=most severe tics.|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
1268727|NCT00370682|Secondary|Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose|"Percentage of subjects with incidence of measurable dengue viremia at specified time points after each dose.~Negative = GEQ/uL results is equal to zero Undetermined = GEQ/uL result is below LOD Positive = GEQ/uL result is >=LOD Missing = No data PI(M1) = Post Dose 1, Month 1 PII(D2,5,8,12) = Post Dose 2, Days 2, 5,8 and 12 PII(D5,8,12,14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7"|within 7 months||||% of subjects|||Number
1268728|NCT00370682|Secondary|Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines|"Seropositivity rates for neut. antibodies according to pre-vaccination flavivirus immune status-primed/unprimed subjects.~PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7 PII(M9) = Post Dose 2, Month 9"|9 months||||% of subjects||95% Confidence Interval|Number
1278748|NCT00284557|Primary|BMI Z-score(for Gender and Age)at 12-months|The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.|12-months post-intervention||||Z-score||Standard Deviation|Mean
1268732|NCT00370682|Secondary|Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose|"Laboratory valuesabove the alert values within 31 days (days 0-30) after each vaccine dose. Change from baseline in hematological and biochemical levels with respect to normal ranges.~PI(D2, 5, 8, 12) = Post Dose 1, Days 2, 5, 8 and 12 PI(D5, 12,14) = Post Dose 1, Days 5, 12 and 14 PI(M1) = Post Dose 1, Month 1 PI(M6) = Post Dose 1, Month 6 PII(D2, 5, 8, 12) = Post Dose 2, Days 2, 5, 8 and 12 PII(D5, 8, 12, 14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7"|within 31 days after each vaccine dose||||subjects|||Number
1268733|NCT00370682|Secondary|Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period|Number of subjects experiencing serious adverse events (SAEs) throughout the entire 9 month study period|9 months||||Participants|||Count of Participants
1268734|NCT00370682|Secondary|Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose|Incidence of unsolicited AEs reported within the 31-day (Days 0-30) post-vaccination period for each study vaccine|0-30 days after each study vaccine dose||||unsolicited AEs|||Number
1268735|NCT00370682|Secondary|Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine|Percentage of subjects with any adverse events (AEs) solicited and unsolicited reported during the 21-day post-vaccination period following dose 2|0-21 days after dose 2 of study vaccine||||percentage of subjects||95% Confidence Interval|Number
1268736|NCT00370682|Primary|Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2|Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)|30 and 90 days after dose 2||||GMTs||95% Confidence Interval|Mean
1268737|NCT00370682|Primary|Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1|Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)|0-21 days after dose 1||||percentage of subjects||95% Confidence Interval|Number
1268738|NCT00370552|Secondary|Number of Participants With Abnormalities in Renal Function by Worst CTC Grade|Creatine Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug and had samples available.|||Participants|||Number
1268739|NCT00370552|Secondary|Number of Participants With Abnormalities in Liver Function by Worst CTC Grade|ULN=Upper limit of normal.ALT Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; AST Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; ALP Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Total bilirubin Gr 1: >ULN to 1.5*ULN, Gr 2: >1.5 to 3.0*ULN, Gr 3: >3.0 to 10.0*ULN, Gr 4: >10.0*ULN.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug and had samples available.|||Participants|||Number
1268740|NCT00370552|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade|CTC, Version 3 used to assess parameters. CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count. LLN=lower level of normal. WBC Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L; Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug.|||Participants|||Number
1268741|NCT00370552|Primary|Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart.|Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression|All randomized participants|||Participants|||Number
1268742|NCT00370552|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug|All randomized participants who received any study drug.|||Participants|||Number
1268743|NCT00370552|Secondary|Percentage of Participants Surviving at 1 Year|One year survival rates were computed using Kaplan-Meier estimates.|Date first participant enrolled to 1 year|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1268744|NCT00370552|Secondary|Median Duration of Response|Duration of response was computed for participants whose best response was either PR or CR. Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death. Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment.|Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)|Participants whose best response was CR or PR, as assessed by the investigator.|||Months||95% Confidence Interval|Median
1278749|NCT00284557|Secondary|"Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and Screen Time"||6- and 12-months post-intervention|||||||
1268745|NCT00370552|Secondary|Median Time to Response|Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first. Time to response was computed only for participants whose best response was PR or CR.|Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)|Participants whose best response was CR or PR, as assessed by the investigator.|||Weeks||Full Range|Median
1268746|NCT00370552|Secondary|Median Progression-free Survival (PFS)|PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression. Participants who did not progress or die were to be censored on the date of their last tumor assessment.|Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)|All randomized participants.|||Months||95% Confidence Interval|Median
1268747|NCT00370552|Secondary|Percentage of Participants With Progression-free Survival at Week 24|Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24. Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months.|Date of randomization to Week 24|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
1268748|NCT00370552|Primary|Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study|CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.|Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
1268749|NCT00370396|Secondary|Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens|A BST responder to PT, FHA and PRN antigens was defined as a subject with the appearance of antibodies in subjects who were seronegative prior to the booster vaccination or at least 2-fold increase of pre-booster vaccination antibody concentrations in subjects who were seropositive prior to the booster vaccination. A seropositive/seronegative subject as regards Anti-PT/-FHA/ -PRN antibodies was defined as a subject with anti-PT/-FHA/ -PRN antibody concentrations ≥ 5 Enzyme-linked Immunosorbent assay (ELISA) unit per milli-liter (EL.U/mL)|One month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
1268750|NCT00370396|Secondary|Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers|Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1268751|NCT00370396|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Anti-HBs antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in milli-International unit per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 10 mIU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1268752|NCT00370396|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Anti-D and Anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1268759|NCT00370396|Secondary|Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects enrolled in the ESFU Phase of the study.|Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1270263|NCT00358735|Post-Hoc|Total Number of Blood Transfusion Units|Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included)|Between the immediate postoperative measurement and discharge||||Units|Participants||Number
1268753|NCT00370396|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Anti-PT, Anti-FHA and Anti-PRN concentrations measured by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 5 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1268754|NCT00370396|Secondary|Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off for the assay for the purpose of this endpoint was ≥ 0.15 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1268755|NCT00370396|Secondary|Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1268756|NCT00370396|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1268757|NCT00370396|Secondary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) – by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA)|Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1268758|NCT00370396|Secondary|Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens – by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA)|A seroprotected subject as regards anti-pneumococcal serotype antibody was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month after (Month 1) booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
1268760|NCT00370396|Secondary|Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity . The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007.|Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1268761|NCT00370396|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007.|Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1268762|NCT00370396|Secondary|Number of Subjects With Any and Any Grade 3 Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.|Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets..|||Participants|||Count of Participants
1268763|NCT00370396|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.|Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets..|||Participants|||Count of Participants
1268764|NCT00370396|Primary|Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups|Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature > 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (Synflorix™ or Prevenar™ vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.|Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets.|||Participants|||Count of Participants
1268765|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the motivation and energy inventory-short form (MEI-SF) questionnaire. Scores could range from 0 (worst possible) to 72 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population|||Points on a scale (0-72)||Standard Deviation|Mean
1268766|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of cancer therapy thrombocytopenia (FACT-Th) questionnaire (six selected items). Scores could range from 0 (worst possible) to 24 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population|||Points on a scale (0-24)||Standard Deviation|Mean
1268767|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of chronic illness therapy fatigue (FACIT-F) questionnaire. Scores could range from 0 (worst possible) to 52 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population|||Points on a scale (0-52)||Standard Deviation|Mean
1268768|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population|||Points on a scale (0-100)||Standard Deviation|Mean
1268769|NCT00370331|Secondary|WHO Bleeding Scale|Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding|Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits|ITT Population|||Percentage of participants|||Number
1268770|NCT00370331|Secondary|Percentage of Participants With a Reduction in Use of Baseline ITP Medication|Percentage of participants who experienced a reduction in their baseline concomitant ITP medication use|From Day 1 through Week 26 on-treatment|ITT Population|||Percentage of participants|||Number
1268771|NCT00370331|Secondary|Maximum and Total Weeks of Platelet Response|Response is defined as a platelet count between 50,000 and 400,000 platelets per microliter.|Day 1 through Week 26 on-treatment|ITT Population|||Weeks||Full Range|Median
1268774|NCT00370331|Primary|Percentage of Responders|The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment|Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment|Intent-to-Treat (ITT) Population: all randomized participants|||Percentage of participants|||Number
1268775|NCT00370292|Primary|Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3|dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).|pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)|Number of participants who received at least one dose of study drug.|||mRNA relative values (ratio with GAPDH)||Standard Deviation|Mean
1268776|NCT00370292|Secondary|Best Objective Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured response (every 14 days for 6 cycles)|Number of participants who received at least one dose of study drug.|||participants|||Number
1268777|NCT00370292|Primary|Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3|dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).|pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)|All participants who received at least one dose of study drug.|||mRNA relative values (ratio with GAPDH)||Standard Deviation|Mean
1268778|NCT00370149|Secondary|Death|Patient Death during hospitalization.|Participants were followed for the duration of the hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.|||participants|||Number
1268779|NCT00370149|Secondary|Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter|A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.|Participants were followed for the duration of hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.|||participants|||Number
1268780|NCT00370149|Primary|Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days|Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.|Participants were followed for the duration of the hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||participants|||Number
1268781|NCT00370071|Secondary|Percentage of Subjects Without EDSS Progression|The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability.The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability. An EDSS progression was defined as increase in EDSS greater than or equal to (>=) 1.0 points (in the treatment period as compared to baseline).|Baseline up to Week 24|FAS|||percentage of subjects|||Number
1268782|NCT00370071|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability. The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability.|Pre-treatment on Day 1, Week 24|FAS subjects with EDSS assessments at the end of the study (Week 24)|||Scores on a scale||Standard Deviation|Mean
1268783|NCT00370071|Secondary|Assessment of Relapses: Relapse Severity|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. A major relapse was defined based on changes on EDSS with the following additional criteria to be met: objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS score or increase of the total EDSS score. Relapses which did not meet the criteria of major relapses were considered as non-major.|Baseline up to Week 24|FAS with all subjects who had reported relapses|||relapses|||Number
1268784|NCT00370071|Secondary|Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment.|After 24 weeks|FAS|||percentage of subjects|||Number
1268897|NCT00369746|Secondary|Quantitative Substance Use Inventory ((SUI)|"Quantitative Substance Use Inventory ((SUI) Measure substance use~Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days"|30 days|All participants who met entry criteria for alcohol abuse or dependence per protocol.|||Days||Standard Deviation|Mean
1268785|NCT00370071|Secondary|Assessment of Relapses: Number of Relapses|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints, and same subjects were counted more than once under each category.|3 and 6 months|FAS with all subjects who had reported relapses|||relapses|||Number
1268786|NCT00370071|Secondary|Assessment of Relapses: Relapse Rate|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature more than (>) 37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. The relapse rate was calculated on an annualized basis. Annualized relapse rate is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all subjects in the group divided by the sum of the number of days on study of all subjects in the group and multiplied by 365.25.|Baseline up to Week 24|Full analysis set (FAS)|||relapses per year|||Number
1268787|NCT00370071|Secondary|Number of T2 Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS|||Lesions||Standard Deviation|Mean
1268788|NCT00370071|Secondary|Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS|||Lesions||Standard Deviation|Mean
1268789|NCT00370071|Secondary|Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS|||cubic millimeter (mm^3)||Standard Deviation|Mean
1268790|NCT00370071|Secondary|Difference Between the Number of New or Enlarging T2 Lesions Per 3 Months During the 6-month Treatment Period and the Number of New or Enlarging T2 Lesions During 3-month Pre-treatment|This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new or enlarging T2 lesions during the 3-month pre-treatment period from the cumulative number of new or enlarging T2 lesions during the 6-month treatment period divided by 2 (number of new T2 lesions per three months) based on non-enhancing lesions on T1 weighted scans|after 6 months of treatment as compared to the 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.|||lesions||Full Range|Median
1268791|NCT00370071|Secondary|Difference Between the Number of New Gadolinium (Gd)-Enhancing Lesions Per 3 Months During the 6-month Treatment Period and the Number of New Gd-enhancing Lesions During 3-month Pre-treatment|This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new Gd-enhancing lesions during the 3-month pre-treatment period from the cumulative number of new Gd-enhancing lesions during the 6-month treatment period divided by 2 (number of new Gd-enhancing lesions per three months)|after 6 months of treatment as compared to 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.|||lesions||Full Range|Median
1268792|NCT00370071|Primary|Difference Between the Number of Newly Active Lesions in Magnetic Resonance Imaging (MRI) Per Three Months During the 6-month Treatment Period and the Number of Newly Active Lesions During 3-month Pre-treatment|The primary efficacy variable was calculated by subtracting the number of newly active lesions during the 3-month pre-treatment period from the cumulative number of newly active lesions during the 6-month treatment period divided by 2 (number of newly active lesions per three months, new lesion frequency per 3 months)|after 6 months of treatment as compared to 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.|||lesions||Full Range|Median
1268793|NCT00370032|Secondary|Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons|On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|Population: modified per protocol to include placebo information only.|||ml per minute per 100 grams of tissue||Standard Deviation|Mean
1268794|NCT00370032|Secondary|Rectal Mucosal Blood Flow (MBF)|On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period||||ml per minute per 100 grams of tissue||Standard Deviation|Mean
1268795|NCT00370032|Primary|Left Colon Mucosal Blood Flow (MBF)|On Day 6 of each treatment period; 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There were no pre-treatment LDF procedure, MBF was compared between the Healthy volunteers and D-irritable bowel syndrome (IBS) cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|Per Protocol Population - the population used for the primary and secondary outcome analyses. The population consisted of all randomized subjects who completed the study with MBF measurements for both treatment periods.|||ml per minute per 100 grams of tissue||Standard Deviation|Mean
1268796|NCT00369967|Secondary|Patient Satisfaction|Rating of patient satisfaction with method|3, 6, and 12 months|None of the participants returned their satisfaction survey||||||
1268797|NCT00369967|Secondary|Bleeding Profile||3, 6, and 12 months|None of the participants returned their menstrual calendars to assess this outcome||||||
1268798|NCT00369967|Secondary|Pregnancy|Number of pregnancies reported|3,6, and 12 mo|There were no reported pregnancies during the study period|||participants|||Number
1268802|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268803|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268804|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268805|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 240|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268806|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 156|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|156 Weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268807|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 96|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268808|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268809|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268810|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268811|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268812|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268813|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268814|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268815|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268816|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268817|NCT00369941|Secondary|Number of Participants With LAEs at Week 240|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268818|NCT00369941|Secondary|Number of Participants With LAEs at Week 156|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268819|NCT00369941|Secondary|Number of Participants With LAEs at Week 96|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268820|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268821|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268822|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268823|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 240|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268824|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 156|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268825|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 96|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268826|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 240|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268827|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 156|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268828|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 96|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268829|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 240|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268830|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 156|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268831|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 96|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268832|NCT00369941|Secondary|Number of Participants That Died by Week 240|All participant deaths in the span of 240 weeks on study were recorded.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268833|NCT00369941|Secondary|Number of Participants That Died by Week 156|All participant deaths in the span of 156 weeks on study were recorded.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268834|NCT00369941|Secondary|Number of Participants That Died by Week 96|All participant deaths in the span of 96 weeks on study were recorded.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268835|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 240|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268836|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 156|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268848|NCT00369941|Primary|Number of Participants That Discontinued With Serious CAEs at Week 48|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268837|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 96|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268838|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 240|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268839|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 156|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268840|NCT00369941|Primary|Number of Participants Discontinued With Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse events (AEs) in this study were defined as drug-related if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268841|NCT00369941|Primary|Number of Participants Discontinued With LAEs at Week 48|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268842|NCT00369941|Primary|Number of Participants With Serious Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268843|NCT00369941|Primary|Number of Participants With Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268844|NCT00369941|Primary|Number of Participants With Serious LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268845|NCT00369941|Primary|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1268846|NCT00369941|Primary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268847|NCT00369941|Primary|Number of Participants That Discontinued With Drug-related CAEs at Week 48|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268898|NCT00369746|Secondary|Timeline Follow Back (TLFB) Average Drinks Per Drinking Day|This variable reports average drinks/drinking day in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol|||drinks per drinking day||Standard Deviation|Mean
1268851|NCT00369941|Primary|Number of Participants With Serious Drug-related CAEs at Week 48|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268852|NCT00369941|Primary|Number of Participants With Drug-related CAEs at Week 48|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268853|NCT00369941|Primary|Number of Participants With Serious CAEs at Week 48|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268854|NCT00369941|Primary|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268855|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 96|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268856|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 240|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268857|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 156|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268858|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 96|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268859|NCT00369941|Secondary|Number of Participants With CAEs at Week 240|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268860|NCT00369941|Secondary|Number of Participants With CAEs at Week 156|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268861|NCT00369941|Secondary|Number of Participants With CAEs at Week 96|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268862|NCT00369941|Secondary|Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8|Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression|8 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
1268863|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 240|Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)|Baseline and Week 240|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
1268864|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240.|240 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
1268865|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240.|240 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
1278750|NCT00284557|Primary|BMI Z-score(for Gender and Age)at 6-months|The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.|6-months post-intervention||||Z-score||Standard Deviation|Mean
1268866|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 156|Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)|Baseline and Week 156|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
1268867|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156.|156 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
1268868|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156.|156 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
1268869|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 96|Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)|Baseline and Week 96|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
1268870|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96.|96 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
1268871|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96.|96 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
1268872|NCT00369941|Secondary|Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48|Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)|Baseline and Week 48|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
1268873|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.|48 Weeks|All participants who took study medication and had HIV RNA tests performed were included in this analysis.|||Participants|||Number
1268874|NCT00369941|Primary|Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.|48 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
1268875|NCT00369928|Primary|Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks|percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks|12 weeks||||percent meeting ACR 20||95% Confidence Interval|Number
1268876|NCT00369915|Secondary|Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale (HARS) has a range of scores from 0 to 56 where the highest values indicate the most anxiety.|Each of 12 sessions.|Only study completers were analyzed.|||units on a scale||Standard Deviation|Mean
1268877|NCT00369915|Primary|Change in Depression Severity|The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of scores from 0 to 60 where the highest values indicate the most depression.|Outcome measures obtained at each of 12 sessions|Only participants who completed the trial were included in the analysis.|||units on a scale||Standard Deviation|Mean
1268878|NCT00369824|Secondary|Number of Subjects Reporting Medically Significant Adverse Events (AEs)|Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)||||Participants|||Count of Participants
1268879|NCT00369824|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes|During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)||||Participants|||Count of Participants
1268880|NCT00369824|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)||||Participants|||Count of Participants
1268881|NCT00369824|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 30-day period following each vaccination||||Participants|||Count of Participants
1268882|NCT00369824|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria|During the 7-day period following each vaccination|Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least|||Participants|||Count of Participants
1268883|NCT00369824|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day period following each vaccination|Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least|||Participants|||Count of Participants
1269071|NCT00368459|Secondary|Function, Activities of Daily Living|Change from baseline at 6 months, compared between groups. Range 0-78. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
1268884|NCT00369824|Secondary|Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response|"Vaccine responses for anti-A, C, Y and W-135 defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32)~For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer"|One month after vaccination with Menactra|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups|||Participants|||Count of Participants
1268885|NCT00369824|Secondary|Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN|"Booster responses defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,~For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,~For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer"|One month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix + Cervarix groups.|||Participants|||Count of Participants
1268886|NCT00369824|Secondary|Number of Subjects With Booster Response for Anti-D and Anti-T|"Booster responses for anti-D and anti-T defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL)~For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer"|One month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.|||Participants|||Count of Participants
1268887|NCT00369824|Secondary|Concentration of Anti-D and Anti-T Antibodies|Concentrations given as Geometric Mean Concentrations (GMCs)|Before and one month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.|||International Unit per Milliliter||95% Confidence Interval|Geometric Mean
1268888|NCT00369824|Secondary|Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)|Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)|Before and one month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups|||Participants|||Count of Participants
1268889|NCT00369824|Secondary|Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values|Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.|Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity at Month 12/13|||Participants|||Count of Participants
1268890|NCT00369824|Primary|Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies|Titers given as Geometric Mean Titers (GMTs)|Before and one month after vaccination with Menactra|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month1 and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups.|||Titer||95% Confidence Interval|Geometric Mean
1268891|NCT00369824|Primary|Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies|Concentrations given as Geometric Means Concentrations (GMCs)|Before and one month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.|||International Units per Milliliter||95% Confidence Interval|Geometric Mean
1268892|NCT00369824|Primary|Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)|Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)|Before and one month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, Month 1 and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.|||Participants|||Count of Participants
1268893|NCT00369785|Primary|Memory as Quantified by the HVLT-discrimination|In the Hopkins Verbal Learning Test - discrimination, participants are given lists of 12 correct words and 12 incorrect words. HVLT-discrimination is the number of correctly recognized words minus the number incorrectly recognized. The range for this outcome measure is -12 to 12. Higher scores represent better memory.|24 weeks|Number of participants with 24 week memory data|||units on a scale||Standard Error|Least Squares Mean
1268894|NCT00369785|Primary|Memory as Quantified by HVLT-immediate Recall|Memory is quantified using the Hopkins Verbal Learning Test (HVLT) - immediate recall. Participants are asked to recall 12 words. Each recalled word is given one point. They are given three trials. The total score is the sum of the recalled words. The range for HVLT-Immediate recall is 0 to 36. Higher scores represent better memory.|24 weeks|Participants with 24 week HVLT data.|||units on a scale||Standard Error|Least Squares Mean
1268895|NCT00369746|Secondary|Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day|This variable reports maximum drinks per drinking day in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol|||drinks||Standard Deviation|Mean
1268896|NCT00369746|Secondary|Timeline Follow Back (TLFB) Drinking Days Per 30 Days|This variable reports drinking days in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol|||days||Standard Deviation|Mean
1268899|NCT00369746|Primary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range:~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total scoring ranges (0-48):~0-5, No Depression Likely 6-10, Possibly Mildly Depressed 11-15, Moderate Depression 16-20, Severe Depression 21 or Over, Very Severe Depression"|study exit visit, at Week 12|All participants who met entry criteria for alcohol abuse or dependence per protocol.|||units on a scale||Standard Deviation|Mean
1268900|NCT00369707|Post-Hoc|Overall Survival Rate|Overall survival (OS) will be measured from the time of first treatment to death from any cause.|Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, OS rate for all patients is reported at 4 years.||||percentage of patients|||Number
1268901|NCT00369707|Secondary|Progression Free Survival (PFS) Rate|"Progression Free Survival is measured from the time of first induction infusion to disease progression, relapse, second tumor, or death from any cause.~Progressive disease (PD) requires the following:~Appearance of any new lesion or increase by > 50% in the size of previously involved sites.~Increase of > 50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any non measurable disease or nondominant site.~> 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node"|Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS for all patients is reported at 4 years.||||percentage of patients|||Number
1268902|NCT00369707|Secondary|Percentage of Patients With Treatment Failure|Time to Treatment Failure (TTF) rate measured, from the time of first treatment to disease progression, relapse, second tumor, death from any cause, treatment toxicity requiring termination from the study, or for any reason treatment is discontinued permanently.|Median follow up for all patients was 50 months and on intent to treat, TTF rate for all patients is reported at 4 years.||||percentage of patients|||Number
1268903|NCT00369707|Secondary|Correlation of Tumor Burden|"Correlation of tumor burden according to Groupe D’Etude des Lymphomes Follicularies (GELF) with recently developed Follicular Lymphoma International Prognostic Index (FLIPI) prognostic index. All patients enrolled in the study were required to have high tumor burden (HTB) as defined by GELF, where HTB is defined as representing higher risk disease and poorer outcomes than low tumor burden (LTB). Patients were put into low risk or high risk FLIPI groups. Low risk group with a score of 0-2 and high risk group with a score of 3-5.~A FLIPI score of 0 to 1 = “low risk” with a 10 year overall survival of 70%. A score of 2= “intermediate risk” with a 10 year overall survival of 50%. Finally, a score of ≥ 3 is considered “high risk” with a 10 year overall survival of 35%. Data was collected in connection with high or low risk FLIPI and Progression Free Survival (PFS) or Overall Survival (OS) and is reported as percentage patient with high/low risk that are progression free or alive."|At the start of treatment and at Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS and OS for all patients is reported at 4 years.||||percentage of patients|||Number
1268904|NCT00369707|Secondary|Tissue Evaluation|Tissue microarray analysis from paraffin embedded tissue, gene expression profiling from frozen tissue (both from initial node biopsy collected/stored) and whole blood analysis of FCγR polymorphism|At baseline and at response assessment 1 after induction part A, 2, after induction part B and 3, maintenance period.|Insufficient tumor samples were submitted for insufficient number of patients. No data was collected or analyzed.||||||
1268905|NCT00369707|Secondary|Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment|"Assess the safety and tolerance of bortezomib/rituximab as induction and maintenance therapy. Data will be collected for grade 3 and grade 4 adverse events experienced by patients that are determined to be at least possibly related to at least one study drug. Toxicity data for bortezomib/rituximab will be collected on day 1 of every cycle (1 cycle = 35 days) for up to 7 cycles during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Day 1 of each cycle and at the completion of cycles 1 and 3, during treatment up to 12 months||||Participants|||Count of Participants
1268906|NCT00369707|Secondary|Duration of Overall Response|"The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded)until the first date that recurrent or progressive disease is objectively documented.~Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase [LDH]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present).~Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen.~Progressive disease (PD) requires the appearance of any new lesion or increase by > 50% in the size of previously involved sites."|Every 2 months for up to 12 months then every 6 months for 2 years and annually for 1 year|Data was not collected or analyzed for duration of response.||||||
1268907|NCT00369707|Secondary|Overall Response Rate After Completion of Maintenance Therapy|"Overall response rate at completion of bortezomib/rituximab maintenance therapy.~Overall response rate at this time point will be defined as complete response [CR] plus partial response [PR]) after 3 cycles of bortezomib/rituximab induction therapy and up to 4 cycles of maintenance for patients with previously untreated low-grade, B-cell NHL.~Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase [LDH]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present).~Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen."|At baseline and every 2 months during treatment of up to 3 cycles of induction (1 cycle =35days) and 4 cycles of maintenance (1 cycle =2 months) for up to 12 months.||||percentage of patients|||Number
1268908|NCT00369707|Secondary|Overall Response Rate After 1 Course of Induction Therapy|"Overall response rate (ORR) after 1 cycle of bortezomib/rituximab induction therapy.~Overall response rate at this time point will be defined as complete response [CR] plus partial response [PR]) after 1 cycle of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL.~Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase [LDH]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present).~Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen."|At baseline and at the completion of cycle 1 (1 cycle =35 days)||||percentage of patients|||Number
1268909|NCT00369707|Primary|Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment.|"The primary objective of this study is to assess the overall response rate. Overall response rate at this time point will be defined as complete response [CR] plus partial response [PR]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL.~Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase [LDH]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present).~Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen."|At baseline and at the completion of 3 cycles of treatment where 1 cycle equals 35 days.||||percentage of patients|||Number
1268910|NCT00369681|Secondary|Addition of Information to Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers||5 years|Data pertaining to this outcome was not collected.||||||
1268911|NCT00369681|Secondary|Event-free Survival|Percentage of participants who did not experience death, relapse, or progression (worsening) of their lymphoma.|3 years|All evaluable participants.|||percentage of participants||95% Confidence Interval|Number
1268912|NCT00369681|Primary|Relationship Between Marker Detection and Clinical Outcome|Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention.|3 years|Only 21 participants had a detectable CD27(+) ALDH(+) clone prior to study intervention. The remaining participants either did not have such a clone or did not have a sample tested to look for a clone.|||relapses|||Number
1268913|NCT00369681|Primary|Effect of Rituximab on EBV(+) Tumors|Number of relapses among participants who had tumors positive for Epstein-Barr virus (EBV).|Up to 56 months|Only 4 participants had EBV(+) tumors.|||relapses|||Number
1268914|NCT00369668|Primary|Fractionated Reaction Time|Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.|Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Premotor reaction data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.|||milliseconds||Standard Error|Median
1268915|NCT00369668|Primary|Fugl-Meyer Upper Extremity Motor Test|FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.|Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.|||units on a scale||Standard Deviation|Mean
1268916|NCT00369668|Primary|Box and Block Test; Data Collected = Number of Blocks Moved|"A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1 x 1 block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box."|Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.|||Blocks||Standard Deviation|Mean
1268917|NCT00369655|Secondary|Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events||Up to 5 years|All participants who have received previous treatment with anti-HER2.|||Participants|||Number
1268918|NCT00369655|Secondary|Median Duration of Response|Duration of response was defined as for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.|Up to 5 years|Analysis population included only patients who have achieved a confirmed tumor response. The duration of response of 4.6 months is reported from one patient.|||Months||95% Confidence Interval|Median
1268919|NCT00369655|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Time from registration to death or last follow up (up to 5 years)||||Months||95% Confidence Interval|Median
1268920|NCT00369655|Secondary|Progression Free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who died without documentation of progression being considered to have progressed on the date of their death.|Time from registration to disease progression or death (up to 5 years)||||Months||95% Confidence Interval|Median
1268921|NCT00369655|Primary|Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival|The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration. Patients who died without documentation of progression will be considered to have progressed on the date of their death.|6 months|All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.|||Participants|||Number
1268922|NCT00369655|Primary|Proportion of Patients With Confirmed Tumor Response|Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.|Up to 5 years|All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.|||Participants|||Number
1268923|NCT00369629|Primary|Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort.|"Only dose limiting toxicities (DLT) were collected. DLTs were graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~The occurrence of any of the following toxicities during the first treatment cycle constitutes DLT in this study:~Grade 3 and/or 4 non-hematologic toxicity other than grade 3 nausea or vomiting.~Grade 3 and/or 4 unexpected non-hematologic toxicities. Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and fever during first cycle. Grade 4 neutropenia on Day 1 of 2nd treatment cycle despite growth factor support or grade 4 thrombocytopenia on Day 1 of 2nd treatment cycle."|From the day that the first treatment is given through the first 28 day period for each patient.|Patients that experienced a DLT in the first cycle in each cohort. If one DLT is seen in the first 3 patients then 3 more patients are enrolled in that cohort. MTD and is defined as the lowest dose level at which two or more patients experience a DLT. The study closed before enough patients were enrolled to determine the MTD or define DLTs.|||DLT|||Number
1268924|NCT00369590|Secondary|Overall Survival|all patients alive as of the last contact were censored for survival on the basis of that contact date|3 years|The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis|||weeks||Full Range|Median
1268925|NCT00369590|Secondary|Progression Free Survival (PFS) Rate for Subjects With Radiographic Response|"pts with confirmed radiographic response and their rate of progression (PFS).~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|up to 3 years|"Arm1 had total of 7 pts with response however, 2 pts stopped treatment early and were censored at 6 and 10 weeks.~Arm 2 had total to 7 pts with response however 1 pt stopped treatment after 2 weeks but had a 4 week scan showing PR. - pt was censored."|||weeks||95% Confidence Interval|Median
1268926|NCT00369590|Primary|Safety Profile - Events That Discontinued Treatment|number of patients who experienced toxicity that led to being taken off treatment|Approximately 1 year (start of treatment - end of treatment)||||participants|||Number
1268927|NCT00369590|Primary|Safety Profile - Toxicities|number of cycles patient was able to have before developing a toxicity that required removing the patient from treatment. Treatment: Aflibercept 4mg/kg intravenously on day 1 of every 14-day cycle - 2 week cycle.|Start to End of treatment 39 cycles or 1yr 7.5months (78 weeks)||||cycles||Full Range|Median
1268928|NCT00369590|Secondary|Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response|"pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression. All responders were centrally reviewed for confirmation~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|Up to 2 years|The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis|||participants|||Number
1268929|NCT00369590|Primary|Progression-free Survival (PFS) at 6 Months|"This design yields 85% power to detect a true 30% 6-month PFS rate, while maintaining .91 probability of rejecting for a true 15% 6-month PFS rate.~pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression.~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|6 months|"pts not known to be progression free at time of the 6-month scan (24weeks) were considered to experienced treatment failure. If at least 10pts (24%) are progression-frree at 6months (GBM) the agent will be considered promising for futher study.~The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis"|||percentage of participants|||Number
1268930|NCT00369577|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|2 hours|All patients treated|||Participants|||Count of Participants
1268931|NCT00369577|Secondary|Clinical Global Impressions-Improvement Scale (CGI-I) After Drug Administration|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|2 hours|All patients receiving treatment|||CGI-I Units (7=worse, 1=better)||Standard Deviation|Mean
1269072|NCT00368459|Secondary|Clinical Dementia Rating, Sum of Boxes|Change from baseline at 6 months, compared between groups. Range 0-5. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
1268932|NCT00369577|Secondary|BARS Change From Baseline After Drug Treatment|Change from baseline on the Behavioral Activity Rating Scale (BARS) ranging from 1 to 7 where: 1 = difficult or unable to rouse, 2 = asleep but responds normally to verbal or physical contact, 3 = drowsy, appears sedated, 4 = quiet, and awake (normal level of activity), 5 = signs of overt (physical or verbal) activity, calms down with instructions, 6 = extremely or continuously active, not requiring restraint, 7 = violent, requires restraint.|2 hours|All patients receiving experimental treatment|||BARS Score, Change from Baseline, units||Standard Deviation|Mean
1268933|NCT00369577|Primary|PANSS-EC Change From Baseline|The Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|2 hours|The ITT population consisted of all patients who took any study medication and had both baseline data and at least 1 efficacy assessment after the. Any observation recorded after the use of rescue medication was censored and subject to the last observation carried forward algorithm.|||PANSS units||Standard Deviation|Mean
1268934|NCT00369564|Secondary|Ability to Receive All Scheduled Doses of Vincristine|We will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group|10 weeks|||||||
1268935|NCT00369564|Secondary|Frequency and Types of Neurotoxicity Observed|Frequency and types of neurotoxicity observed among those children treated with l-glutamic acid hydrochloride as compared to those who are in the placebo control group|10 weeks|||||||
1268936|NCT00369564|Primary|Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable)|A neurological exam will be completed at baseline and at study week 5 for both strata. An additional exam at week 10 will be done for patients in Stratum 1. Additional exams will be done at any time if the treating oncologist deems it clinically necessary . Neurotoxicity will be scored using a standardized neurological exam form developed for the study that is based on the Modified “Balis” Pediatric Scale of Peripheral Neuropathies. Treatment groups will be compared with respect to the proportion experiencing a grade 2 or higher toxicity from the following list of neurologic toxicities captured on the Neurologic Exam Form including sensory neuropathy, motor neuropathy, laryngeal nerve, constipation/neuro-constipation, jaw pain, or other specified abnormalities noted by the attending physician. Percentage of patients with one or more Grade 2 or higher noted neurotoxicity symptoms on any item in the Balis scale will compared between arms.|10 weeks|Patients reporting baseline and post-baseline observation|||percentage of participants||95% Confidence Interval|Number
1268937|NCT00369512|Primary|Number of Patients With Recurrence at 2 Years|Rate of recurrence at 2 years.|2 years||||participants|||Number
1268938|NCT00369512|Primary|Median Time to Cancer Recurrence|Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence.|2 years||||months||Full Range|Median
1268939|NCT00369512|Primary|Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.|Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events|2 years||||number of adverse events|||Number
1268940|NCT00369486|Secondary|Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks|Primary criterion for retreatment is central subfield thickness >=250 microns. Central subfield thickness of <250 microns indicates no need for retreatment. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.|4, 8, 17, 34 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit|||eyes|||Number
1268941|NCT00369486|Secondary|Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks|Number of eyes that had a reduction in central subfield retinal thickness by ≥ 50% at each follow-up. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.|4, 8, 17, 34 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit|||eyes|Participants||Number
1268942|NCT00369486|Primary|Mean Visual Acuity Letter Score at Each Follow-up Visit|Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0|4, 8, 17, and 34 weeks|The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.|||letter score|Participants|Standard Deviation|Mean
1268943|NCT00369486|Primary|Change in Visual Acuity Letter Score From Baseline Through 34 Weeks|Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity.|4, 8, 17, and 34 weeks|The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.|||letter score|Participants|Standard Deviation|Mean
1268944|NCT00369486|Secondary|Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks|Number of eyes that were retreated at 17 weeks. According to the protocol, primary criterion for retreatment was central subfield thickness >=250 microns or macular edema was still present according to the investigator's judgment.|17 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit|||eyes|Participants||Number
1268945|NCT00369486|Primary|Change in Central Subfield Thickening From Baseline Through 34 Weeks|Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening.|4, 8, 17, 34 weeks|Last Observation Carried Forward was used. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.|||microns|Participants|Standard Deviation|Mean
1268946|NCT00369382|Secondary|Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy||Baseline up to Week 52|Safety population.|||Participants|||Number
1268947|NCT00369382|Secondary|Number of Participants Requiring Antibody Use in Treatment of Acute Rejection|Number of participants requiring antilymphocyte antibody therapy with suspected or biopsy-proven, steroid-resistant, acute rejection with or without hemodynamic compromise. Acute rejection based on ISHLT 1990 criteria: all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.|Baseline to Week 52|Safety population; N=participants who had biopsy-confirmed acute rejection.|||Participants|||Number
1268948|NCT00369382|Secondary|Time to First Acute Rejection|Time from baseline to first biopsy-confirmed acute rejection defined as any of the following (based on ISHLT 1990 criteria): all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.|Baseline to Week 52|Safety population; not analyzed because actual start date of rejection was unknown for those diagnosed by site protocol (SOC) biopsy and protocol-required biopsy.|||Weeks|||Number
1268949|NCT00369382|Secondary|Number of Participants With Biopsy-confirmed Acute Rejection by Severity|Severity of acute rejection summarized using revised 2005 ISHLT criteria. Grade 0R: no rejection, Grade 1R: Focal (perivascular or interstitial) infiltrate without necrosis, diffuse but sparse infiltrate without necrosis, or one focus only with aggressive infiltration and/or focal myocyte damage, Grade 2R:Multifocal aggressive infiltrates and/or myocyte damage, and Grade 3R:Diffuse inflammatory process with necrosis, or diffuse aggressive polymorphous with necrosis, increased infiltrate, changes in edema, hemorrhage and vasculitis.|Baseline to Week 52|Safety population|||Participants|||Number
1268950|NCT00369382|Secondary|Number of Participants With Acute Rejection|Based on International Society for Heart and Lung Transplantation [ISHLT] 1990 criteria: rejections Grade 3A or higher, rejection accompanied by hemodynamic compromise or requiring treatment. Grade 3A or higher included: multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis. Biopsies performed for clinically suspected rejection (for cause), site’s standard of care (site protocol biopsy), or protocol mandated.|Baseline to Week 52|Safety population; n=number of participants analyzed for the specified type of biopsy.|||Participants|||Number
1268951|NCT00369382|Secondary|Overall Survival (OS)|Survival time from the start of study treatment to date of death due to any cause, censored at the last visit if no death. Death was determined from the Death report. The distribution of time to death was to be estimated using Kaplan-Meier method and compared between treatment groups with a proportional hazard model. The number and percent of survival at 6 and 12 months were to be reported.|Baseline until death (up to Week 56)|Safety population: all randomized participants who received at least 1 dose of study medication; not analyzed by Kaplan-Meier because number of events limited to 2 deaths in the sirolimus group.|||Weeks|||Number
1268952|NCT00369382|Secondary|Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)|The change in creatinine clearance over time assessed using the random coefficient slope of the regression line with creatinine clearance as the dependent variable and study day as the independent variable. Time points calculated as study days, relative to time of randomization of study medication. Observed data multiplied by a scale factor of 365 to express an annual change.|Baseline to discontinuation (up to Week 52)|ITT; N=participants with all measurements required for calculated creatinine clearance. All observed data up to the point of discontinuation of the study were used.|||mL/min/1.73m^2||95% Confidence Interval|Number
1268953|NCT00369382|Secondary|Serum Creatinine Level at Baseline|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine.|Baseline|ITT.|||mcmol/L||Standard Deviation|Mean
1268954|NCT00369382|Secondary|Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week x minus baseline level where higher scores represented decreased kidney function. Least squares mean adjusted for treatment group and center.|Baseline and Weeks 4, 16, 24, 32, 40, and 52|ITT, All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study.|||mcmol/L||Standard Error|Least Squares Mean
1268955|NCT00369382|Secondary|Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline|Creatinine clearance calculated using MDRD equation. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.|Baseline|ITT.|||mL/min/1.73m^2||Standard Deviation|Mean
1268956|NCT00369382|Secondary|Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization|Creatinine clearance calculated using MDRD equation. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function. Least squares mean adjusted for baseline calculated creatinine clearance (MDRD) and center.|Baseline and Weeks 4, 16, 24, 32, 40 and 52|ITT; All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
1268957|NCT00369382|Secondary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization|Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.|Baseline and Weeks 4, 16, 24, 32, and 40|ITT; All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study; N=participants with all measurements required for calculated creatinine clearance.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
1268958|NCT00369382|Primary|Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline|Creatinine clearance at baseline calculated using Cockcroft-Gault equation and adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.|Baseline|ITT; N=participants with all measurements required for calculated creatinine clearance.|||mL/min/1.73m^2||Standard Deviation|Mean
1268959|NCT00369382|Primary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization|Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (≥) 90 milliliters per minute per 1.73 meters squared (mL/min/1.73m^2). Change from baseline=CC at Week 52 minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.|Baseline and Week 52|Intent-to-Treat (ITT) Population: all randomized participants; all available data (on-therapy and off-therapy) included; Last observation carried forward (LOCF) for data missing due to skipped visits or participant withdrawal from study. Number of participants analyzed (N)=those with all measurements required for calculated creatinine clearance.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
1268960|NCT00369343|Secondary|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of “new symptoms” and “old (but worse) symptoms” (1) and 0 for “old and unchanged symptom,” “absent,” or “old symptom but improved” for a total possible range of 0 to 43. A higher score indicates more symptoms.|6 months|Open-label (OL) safety population: Patients completed double-blind and continued in OL with ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with <4 wks therapy. Patients analyzed varied by time (0mg, 100mg, 200mg): Early Termination (n=9,98,207); Taper week 1 (n=4,76,193); Taper week 2 (n=5,75,195); Post-taper (n=5,71,192)|||units on scale||Standard Deviation|Mean
1268961|NCT00369343|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|open label baseline to 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||units on scale||Standard Deviation|Mean
1268962|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.|open label baseline to 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||units on scale||Standard Deviation|Mean
1268963|NCT00369343|Secondary|Percentage of Patients Achieving a Response to Treatment|A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||percentage of patients responding|||Number
1268964|NCT00369343|Secondary|Percentage of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||percentage of patients|||Number
1268965|NCT00369343|Secondary|Clinical Global Impression Improvement (CGI-I) Score|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase.|||units on scale||Standard Deviation|Mean
1268966|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.|open label baseline and 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||units on scale||Standard Deviation|Mean
1268967|NCT00369343|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
1268968|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.|||units on scale||Standard Error|Mean
1268969|NCT00369343|Secondary|Percentage of Patients Achieving Response to Treatment|A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).|||percentage of patients|||Number
1268970|NCT00369343|Secondary|Percentage of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).|||percentage of patients|||Number
1268971|NCT00369343|Secondary|Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).|||percentage of patients|||Number
1268972|NCT00369343|Primary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, who took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.|||units on scale||Standard Error|Mean
1268973|NCT00369317|Secondary|Gene Expression Profiles by Microarrays|A hierarchical clustering algorithm is used to assemble the genes into a dendrogram or tree structure with branches containing genes with similar patterns of expression. This ordered representation can be graphically displayed with colors that reflect the qualitative and quantitative relationships of the expressed genes.|At baseline and at the time of relapse (if available)|The Microarray analysis secondary outcome is not available because the number of specimens with good quality wasn’t sufficient to yield meaningful results.||||||
1268974|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of half-life of elimination. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data for half-life of elimination (n=146) are excluded.|||Mean minutes||Standard Deviation|Mean
1268975|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of area under the concentration time curve. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data for area under the concentration time curve (n=146) are excluded.|||Mean micromolar x minutes||Standard Deviation|Mean
1268976|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of peak plasma concentration. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data from peak plasma concentration (n=146) are excluded.|||Mean micromolar||Standard Deviation|Mean
1268977|NCT00369317|Secondary|Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry|Proportion of participants in complete remission by morphology and with positive MRD by flow cytometry among patients having evaluable remission and MRD assessment.|After Induction I therapy (day 28 from start of therapy)|Ineligible patients (n=1) are excluded. Patients without available MRD at end of Induction I (n=58) or not evaluable for morphologic remission assessment (n=7) are excluded. MRD data are not available at end of Induction IV or after completion of Intensification therapy.|||Proportion of participants|||Number
1268978|NCT00369317|Secondary|Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis|Proportion of participants having GATA1 mutation among patients with phenotype data available.|At baseline and at the end of therapy (intensification) or disease relapse|Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=158). Data are not available at end of therapy or relapse.|||Proportion of participants|||Number
1268979|NCT00369317|Secondary|Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry|Proportion of participants having megakaryoblastic subtype (AMkL) phenotype among patients with phenotype data available.|At the start of therapy|Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=40). Data are not available at end of therapy or relapse.|||Proportion of participants|||Number
1268980|NCT00369317|Secondary|Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Proportion of participants with at least one grade 3 or higher adverse event during therapy.|From the beginning of induction therapy to the end of intensification therapy|Ineligible patients (n=1) are excluded.|||Proportion of participants|||Number
1268981|NCT00369317|Secondary|Induction Remission Rate|Proportion of participants with a remission after four courses of Induction therapy.|End of induction therapy (day 112)|Ineligible (n=1) patients are excluded. Patients who withdrew from therapy before completing 4 courses of Induction and did not die or relapse are not evaluable (n=9) for Induction remission rate.|||Proportion of participants|||Number
1268982|NCT00369317|Primary|Overall Survival (OS) at 3 Years||Time from study entry to death, assessed at 3 years.|Ineligible patients are excluded from analyses of overall survival and event free survival.|||percentage||95% Confidence Interval|Number
1268983|NCT00369317|Primary|Event-free Survival (EFS) at 3 Years||Time from study entry to induction failure, relapse, or death assessed at 3 years.|Ineligible patients are excluded from analyses of event free survival and overall survival.|||percentage||95% Confidence Interval|Number
1268984|NCT00369278|Secondary|Renal Function as Measured by Glomerular Filtration Rate (GFR)|"The Glomerular Filtration Rate (GFR) was calculated using the following formulas:~Cockcroft-Gault formula: calculation using the participant's age, gender, weight, and serum creatinine levels.~MDRD formula: calculation using the participant's age, gender, serum creatinine, urea nitrogen, and albumin levels."|6 months|Intent-to-treat population for whom data was available. End of Study data was imputed using Last Observation Carried Forward (LOCF).|||ml/min||Standard Deviation|Mean
1268985|NCT00369278|Primary|Number of Participants With Any Treatment Failure|Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.|6 months||||Participants|||Number
1268986|NCT00369278|Secondary|Renal Function as Measured by Serum Creatinine||6 months||||mg/dL||Standard Deviation|Mean
1268987|NCT00369278|Secondary|Time to “Event” for the Composite Endpoint as Well as All Individual Components of That Endpoint “Treatment Failure” Including Clinical Rejections|Due to a small number of events, median time to <event> was not reached.|6 months|||||||
1268988|NCT00369278|Secondary|Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180|Due to a small number of events, median time to <event> was not reached.|6 months|||||||
1269073|NCT00368459|Secondary|ADAS-cog|Change from baseline at 6 months, compared between groups. Error score range 0-70. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
1268989|NCT00369278|Secondary|Number of Participants With Single Treatment Failures|"Rates for all individual components of the primary endpoint ‘treatment failure’ until day 180:~Acute rejection diagnosed by biopsy (BPAR)~graft loss~death~loss to follow up~discontinuation from study drug due to lack of efficacy or toxicity (adverse events, every adverse event had to be interpreted as toxicity)~conversion to another dosing regimen (conversion to tacrolimus, prograf, etc.)"|6 months|Intent-to-treat population|||Participants|||Number
1268990|NCT00369278|Primary|Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment|Median time to first occurrence of treatment failure was not reached in this study.|6 months|||||||
1268991|NCT00369278|Primary|Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L|Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.|Assessed on day 3, 10, 21, 42, 56 and 84|Pharmacokinetic profiles were performed only in patients involved in Phase I of the study. The pharmacokinetic population consisted of 42 participants.|||Days||95% Confidence Interval|Median
1268992|NCT00369265|Primary|Percentage of Participants With Improvement or Resolution of Arytenoid Erythema|Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks|6 weeks|No results to report; Study was terminated||||||
1268993|NCT00369226|Secondary|Overall Survival and Progression-free Survival.|Progression is defined as disease relapse or disease progression since transplant.|by 1 year after PBSC infusion||||percentage of participants||95% Confidence Interval|Number
1268994|NCT00369226|Secondary|Incidence of Chronic Graft Versus Host Disease (Chronic GVHD).|Number of participants with chronic GVHD at 1 year post transplant.|by 1 year after PBSC infusion||||percentage of participants||95% Confidence Interval|Number
1268995|NCT00369226|Secondary|Sustained Engraftment Following Transplant.|As measured by median total donor chimerism at day 100.|by day 100 post transplant|Several subjects experienced failure to graft, relapse or death prior to assessment and were removed from analysis.|||percentage of participants|||Number
1268996|NCT00369226|Primary|Incidence of Grade II-IV Acute Graft Versus Host Disease (GVHD) by Day 100.||by day 100 after peripheral blood stem cell (PBSC) infusion||||percentage of participants||95% Confidence Interval|Number
1268997|NCT00369226|Primary|Successful Initial Engraftment by Day 45 Post Peripheral Blood Stem Cell (PBSC) Infusion and Administration of Bortezomib (Velcade), Tacrolimus and Methotrexate|Percentage of participants who did not experience failure to engraft or relapse or death before assessment.|by day 45 post PBSC infusion||||percentage of participants|||Number
1268998|NCT00369226|Primary|The Maximally Tolerated Dose (MTD) of Bortezomib (Velcade) That Can be Administered With Tacrolimus and Methotrexate After Mismatched Allogeneic Non-myeloablative Peripheral Blood Stem Cell (PBSC) Transplantation|"The MTD of bortezomib was evaluated at 3 dose levels:~Dose level 1: 1.0 mg/m^2 Dose level 2: 1.3 mg/m^2 Dose level 3: 1.5 mg/m^2 Cohorts of 3-5 pts were enrolled at each dose level. At any dose level, if no DLT in the first 3, 4, or 5 pts, then dose escalation would occur.~If 3 evaluable pts in cohort, and 1 of 3 experiences DLT then 2 additional pts treated at the same dose level. If >=1 of 2 additional pts experience DLT then previous dose level will be MTD. If no DLT in additional 2 pts then dose escalation will occur. If 4 evaluable pts in cohort, and 1 of the 4 experiences DLT then 1 additional pt treated at same dose level. If this additional pt experiences DLT then the previous dose will be declared to be the MTD. If additional pt does not experience DLT, then dose escalation will take place. If 5 evaluable pts in cohort, and 1 experiences DLT, then dose escalation will take place. If >=2 of first 3, 4, or 5 pts experience DLT then the previous dose will be declared MTD."|by day 45 post PBSC infusion||||mg/m^2|||Number
1268999|NCT00369161|Secondary|Percentage of Participants With Efficacy Failure|Efficacy failure was a composite of BPAR, graft loss, death or lost to follow-up. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy. An allograft was presumed to be lost on the day a patient started dialysis and was unable to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss.|Month 12|Intention to treat (ITT) population.|||percentage of participants|||Number
1269000|NCT00369161|Secondary|Number of Participants With Incidence of Biopsy-proven Acute Rejection (BPAR)|Biopsy-proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy.|from Month 4 through to Month 12|Intention to treat (ITT) population.|||participants|||Number
1269001|NCT00369161|Primary|Renal Function Assessed by Calculated Glomerular Filtration Rate (cGFR)|"Renal function was assessed by calculated glomerular filtration rate (cGFR) using Modification of Diet in Renal Disease (MDRD)formula.~GFR [mL/min/1.73m^2] = 186.3*(C-1.154)*(A-0.203)*G*R, where:~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|12 months post -transplant|Modified Intent-to-treat (ITT) population i.e patients with an available cGFR at month 12.|||mL/min/1.73m^2||Standard Deviation|Mean
1269002|NCT00369122|Secondary|Overall Survival (Three-year Rate Reported)|Overall survival time is defined as time from registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to 3 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1269003|NCT00369122|Secondary|Disease-free Survival (Three-year Rate Reported)|Failure is defined as local, regional, or distant disease, or death due to any cause. Disease-free survival time is defined as time from registration to the date of failure and disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive and disease-free are censored at the date of last contact.|From registration to 3 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1270264|NCT00358735|Post-Hoc|Events of Clinical Sign and Symptoms of VTE (DVT and/or PE)|Events of clinical Sign and symptoms of VTE (DVT and/or PE), confirmed by standard objective diagnostic methods|Day of surgery and up to 3 months||||Events|Participants||Number
1269004|NCT00369122|Secondary|Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.|Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Gr >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.|From start of treatment to last follow-up, up to 6.0 years. Analysis occurred after all patients had been on study for at least 2 years.|Eligible patients who started study treatment|||participants|||Number
1269005|NCT00369122|Primary|Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.|Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.|From start of treatment to 90 days.|Eligible patients who began study treatment.|||participants|||Number
1269006|NCT00368992|Secondary|Response Rate|Confirmed and unconfirmed complete and partial responses per RECIST in the subset of patients with at least one target lesion assessed by CT or MRI. A complete response (CR) was defined as disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a >= 30% decrease in the sum of the longest diameters of all target lesions. A CR or PR was confirmed if documented a second time at least 4 weeks after the first documentation.|Every 6 weeks while on protocol treatment, up to 3 years.|Eligible patients who received protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1269007|NCT00368992|Secondary|Overall Survival|From date of enrollment to date of death due to any cause. Patients last known to be alive were censored at date of last contact.|Once a week, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.|||months||95% Confidence Interval|Median
1269008|NCT00368992|Secondary|Progression-Free Survival|From data of registration to date of disease progression (as defined by RECIST, i.e. a 20% increase in the sum of the longest diameters of target lesions, or unequivocal progression ina non-target lesion in the opinion of the treating investigator, or the appearance of new lesions), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.|Every 6 weeks until disease progression. After 9 months, every 12 weeks until disease progression, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.|||Months||95% Confidence Interval|Median
1269009|NCT00368992|Primary|The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment.|All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.|Every week until removed from protocol therapy, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1269010|NCT00368979|Secondary|Number of Participants With Qmax Improvement From Baseline at Week 52|Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||participants|||Number
1269011|NCT00368979|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52|Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||milliliters per second (mL/sec)||Standard Deviation|Mean
1269012|NCT00368979|Secondary|Number of Participants With IPSS Improvement From Baseline at Week 52|Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||participants|||Number
1269013|NCT00368979|Secondary|Percent Change From Baseline in Prostate Volume at Week 52|Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||cubic centimeters (cc)||Standard Deviation|Mean
1270117|NCT00359788|Secondary|FEV1 at 6 Hours at Week 12||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1269014|NCT00368979|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52|The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||score on a scale||Standard Deviation|Mean
1269015|NCT00368966|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
1269016|NCT00368966|Primary|Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose|GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.|One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
1269017|NCT00368966|Primary|Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose||One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
1269018|NCT00368966|Primary|Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose||One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1269019|NCT00368966|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose|Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.|One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1269020|NCT00368966|Primary|Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1269021|NCT00368966|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1269022|NCT00368966|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1269102|NCT00368069|Primary|Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population|Number of POS over the treatment period standardized to 1 week period.|Treatment period (12 weeks)|Intention-to-treat (ITT) (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)|||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
1269023|NCT00368966|Primary|Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series||One month after 2-doses of the infant series (5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
1269024|NCT00368966|Primary|Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series||One month after 2-doses of the infant series (5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1269025|NCT00368966|Primary|Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series|Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.|One month after 2-doses of the infant series (5 months of age)|Evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
1269026|NCT00368940|Secondary|Sheehan Disability Scale.|Sheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability).|Outcome at 12 weeks||||units on a scale||Standard Deviation|Mean
1269027|NCT00368940|Secondary|Hamilton Depression Rating Scale|Hamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression).|Outcome at 12 weeks||||units on a scale||Standard Deviation|Mean
1269028|NCT00368940|Primary|WHO Disability Assessment Schedule (WHODAS)-II|WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).|12-week outcome||||WHODAS-II units||Standard Error|Least Squares Mean
1269029|NCT00368940|Primary|Montgomery Asberg Depression Scale (MADRS)|Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).|12 week outcome||||Units on MADRS scale||Standard Error|Least Squares Mean
1269030|NCT00368927|Secondary|Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention|The number of dysplastic lesions was recorded pre-intervention and post-intervention for each participant in each group. Change in the number of lesions was compared between the two intervention groups.|Baseline and 6 months|The population used for the analysis is patients completing both the pre- and post- intervention bronchoscopy.|||Percent change in number of DL||Full Range|Median
1269031|NCT00368927|Primary|Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment|Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease|Baseline and 6 months|The population used for the analysis is patients completing both the pre- and post-intervention bronchoscopy.|||percentage of participants|||Number
1269032|NCT00368875|Secondary|Overall Survival(OS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until death, assessed up to 12 months|54 patients in the phase I and phase II portion were evaluated|||months||95% Confidence Interval|Median
1269033|NCT00368875|Secondary|Time to Treatment Failure (TTF)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae. Time to treatment failure was not reported for this study.|Time from the first treatment day until disease progression or discontinuation of treatment due to toxicity, assessed up to 12 months|Zero participants analyzed because time to treatment failure was not assessed.||||||
1269034|NCT00368875|Secondary|Progression-free Survival (PFS),|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|From first treatment day until objective or symptomatic progression, assessed up to 12 months|53 patients in the phase I and phase II portions were evaluated|||months||95% Confidence Interval|Median
1269035|NCT00368875|Primary|Objective Response Rate (CR + PR)|Estimated and a 95% confidence interval will be estimated via binomial proportions. Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions and assessed by CT scan: Complete response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Up to 12 months|53 patients in the phase I and phase II portions were evaluated. One patient was not eligible to be evaluated for objective response rate.|||percentage of participants||95% Confidence Interval|Number
1269036|NCT00368875|Primary|Recommended Phase II Dose as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)|Dose-limiting toxcities (DLT) were defined as grade 3-4 febrile neutropenia, thrombocytopenia and non-hemtological toxicity attributed to therapy (nausea, vomiting and diarrhea would be considered dose limiting only if not adequately controlled with therapy). Any toxicity occurring during cycle 1 that resulted in dose reduction of vorinostat or paclitaxel or failure to complete all protocol specificed doses in the first cycle was also considered a DLT|28 days|Three patients were treated at the first vorinostat dose level of 200 mg BID and three additional patients were treated at the second dose level of 300 mg BID|||mg|||Number
1269103|NCT00367991|Secondary|Serum Markers of Apoptosis|Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL.|Day 1 and Day 10|ITT|||pg/mL||Standard Deviation|Mean
1269104|NCT00367991|Secondary|Circulating Endothelial Progenitor Cells||Day 3 and Day 10|Endothelial progenitor cells could not be isolated and are therefore not reported.||||||
1269037|NCT00368849|Secondary|Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score|Although changes in motor symptoms were not hypothesized, the Unified Huntington Disease Rating Scale motor examination was administered at every visit. An experienced motor rater completes a motor examination and rates the participant on several motor tasks. Total score ranges from 0 - 124, with higher scores indicating a worse outcome. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.|||units on a scale||Standard Error|Mean
1269038|NCT00368849|Secondary|Symptom Checklist-90-Revised (SCL-90-R)|Psychiatric symptoms were evaluated with the Symptom Checklist-90-Revised, a self report measure of psychiatric symptoms. The measure produces raw scores and normed scores (T scores Mean = 50), with higher values representing greater impairment. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.|||units on a scale||Standard Error|Mean
1269039|NCT00368849|Primary|Executive Composite Score|The executive composite comprises performance on Trail Making Test Part B, Stroop Color and Word Test, and the Controlled Oral Word Association Test (i.e., Verbal Fluency). The composite score is the average combined z score for each test. Positive values indicate better than average performance and negative values worse than average. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.|||units on a scale||Standard Error|Mean
1269040|NCT00368849|Primary|Attention Composite Score|The attention composite comprises performance on Wechsler Adult Intelligence Scale III Symbol-Digit and Letter Number Sequencing Subtests, Trail Making Test Part A, computerized simple-choice reaction time, and computerized working memory (i.e., 2-Back). The composite score is the average combined z score for each test. Higher, positive values indicate better than average performance and negative and lower values indicate worse than average. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.|||Units on a scale||Standard Error|Mean
1269041|NCT00368849|Primary|Conners' Adult Attention Rating Scale (CAARS)|The Conners' Adult Attention Rating Scale (CAARS) is one of the most frequently used self-rating measures for adult Attention Deficit Hyperactivity Disorder (ADHD) and was given as a self-report measure of attention. It has 66 items with each item ranging from 0 to 3 points. Higher total scores represent greater impairment. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers|||units on a scale||Standard Error|Mean
1269042|NCT00368745|Secondary|Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6)|Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine toxicology assay (each visit Alprazolam Free phase), negative urine alcohol assay (Alprazolam Free Week 6 = endpoint or LOCF). Relapse: > = 2 intakes rescue medication, positive urine and /or alcohol assays, unable to tolerate alprazolam taper, or discontinuation.|Alprazolam Free Week 6|ITT; endpoint = AF Week 6 or LOCF.|||participants|||Number
1269043|NCT00368745|Secondary|Time to First Use of Rescue Medication|The 25th percentile estimate of time until first use of rescue medication is based on Kaplan-Meier estimates. Event day is the study day when the subject first used rescue medication. Rescue medication: packet with 2 doses alprazolam to take only in the event subject experiences severe symptoms of benzodiazepine withdrawal or rebound anxiety.|Baseline, Week 13 (Final Visit/Early Termination)|ITT; Week 13 (Final Visit/Early Termination) or LOCF|||days|||Number
1269044|NCT00368745|Secondary|Time to Discontinuation|The 25th percentile estimate of time until discontinuation is based on Kaplan-Meier estimates. Event day is the study day when the subject discontinued from study.|Baseline, Week 13 (Final Visit/Early Termination)|ITT; Week 13 (Final Visit/Early Termination) or LOCF.|||days|||Number
1269045|NCT00368745|Secondary|Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores|DSST: subject-rated; evaluates aspects of cognition (includes attending to directions, processing speed, sustained attention, visual-motor integration, learning and psychomotor speed). Subject matches symbol (1 to 9) with corresponding number key (1 to 9); number of correct symbol-number pairs completed by subject over a 90-second test period determines DSST score. Change: mean at observation minus mean at baseline. Data summarized as change from baseline to endpoint.|Baseline, Endpoint (AF Week 6 )|ITT; subject has baseline and endpoint (final visit) measurement; endpoint = AF Week 6 or LOCF.|||scores on scale||Standard Error|Least Squares Mean
1269046|NCT00368745|Secondary|Mean Scores for Patient Global Impression-Improvement (PGI-I)|PGI-I: subject rated 7-point scale measures change in overall status; range 1 (very much improved) to 7 (very much worse).|Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1269047|NCT00368745|Secondary|Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale|CGI-I: 7-point scale to assess global change in subject condition compared to baseline; range 1 (very much improved) to 7 (very much worse); higher score = more affected.|Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; subject has a baseline and endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1269048|NCT00368745|Secondary|Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores.|CGI-S: 7-point scale to assess global change in subject condition compared to baseline; range 1 (no evidence of illness) to 7 (among the most severely ill); higher score = more affected. Change from baseline: mean at observation minus mean at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; subject has a baseline and at least 1 post-baseline endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1269105|NCT00367991|Secondary|Serum Markers of Myocyte Damage|Myocyte Damage is represented by Creatine phosphokinase (CPK). CPK is measured in U/L, as scalar measure of the enzyme activity. CPK was measured for clinical indications laboratory.|Baseline|ITT|||U/L||Inter-Quartile Range|Median
1269049|NCT00368745|Secondary|Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores.|||scores on scale||Standard Deviation|Mean
1269050|NCT00368745|Post-Hoc|Mean Scores Physician's Withdrawal Checklist (PWC)|Mean scores at each visit for PWC: 20-item physician-rated interview measures presence of anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception, and cognition); range 0 (not present) to 3 (severe). Total score: 0 to 60; higher score = more affected. Mean scores entered as post-hoc analysis as Mean change from baseline in PWS scores not analyzed: PWS not measured at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6 )|ITT; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. Endpoint = AF Week 6 or LOCF. Refer to measure Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores.|||scores on scale||Standard Error|Least Squares Mean
1269051|NCT00368745|Secondary|Number of Subjects With > = 5 New PWC Symptoms|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline.|Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; data not analyzed: PWC not measured at baseline.|||particpants|||Number
1269052|NCT00368745|Secondary|Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline.|Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; data not analyzed: PWC not measured at baseline.|||particpants|||Number
1269053|NCT00368745|Secondary|Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); lower score indicates less affected. Change from baseline: mean at observation minus mean at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6)|ITT; subject has a baseline and at least 1 post-baseline measurement before week 13; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1269054|NCT00368745|Primary|Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free|Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine benzodiazepine psychoactive toxicology assay (each visit Alprazolam Free phase); negative serum benzodiazepine alcohol assay (endpoint or LOCF).|Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1)|Intent to Treat (ITT) population: received at least 1 dose pregabalin or placebo. Primary outcome ITT = all treated subjects in alprazolam free phase. Endpoint = Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1.|||participants|||Number
1269055|NCT00368654|Secondary|Adverse Events (AE)|measured by whether or not AE was serious|16 vs. 36 weeks, depending on study arm|Data not collected||||||
1269056|NCT00368654|Primary|PASI -- Psoriasis Area and Severity Index|(PASI) - given by numerical score, the index shows the severity of psoriasis.|16 vs. 36 weeks, depending on study arm|data not collected||||||
1269057|NCT00368641|Primary|All-cause Hospitalization (Unadjusted)|All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.|6 to 24 months|intent to treat population|||hospitalizations per year||95% Confidence Interval|Mean
1269058|NCT00368550|Secondary|Change in the Level of Alcohol-related Problems|Measured using the SIP (Short Inventory of Problems), which was administered at pretreatment and at the end of treatment. The range of scores on the SIP is 0 (no alcohol-related problems) to 45 (most severe alcohol-related problems) and the time frame for reporting is the preceding 3 months. The data presented here represent a difference score of treatment minus baseline.|12-week treatment period compared with baseline value||||Units on a scale||Standard Deviation|Mean
1269059|NCT00368550|Secondary|Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)|Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.|12-week treatment period||||days||Standard Deviation|Mean
1269060|NCT00368550|Primary|Number of Days on Which Subjects Drank|Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.|12-week treatment period|All randomized subjects with missing days imputed as drinking days.|||days||Standard Deviation|Mean
1269061|NCT00368537|Secondary|Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients|Healthcare resource utilization assessment included intensive care unit (ICU) and non-ICU inpatient hospitalization. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|All patients who received at least 1 dose of study article.|||participants|||Number
1269062|NCT00368537|Secondary|Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate|In vitro activity of the study drugs against a range of pathogenic bacteria that cause complicated skin and skin structure infection (cSSSI) were analyzed using MIC. MIC 50 and MIC 90 are the lowest concentrations of a drug that inhibit the growth of 50% and 90% of a microorganism, respectively. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|"m-mITT: Patients with ≥1 dose of study drug, had cSSSI and baseline isolate from infection site / blood. MIC reported for isolates present in ≥10 m-mITT patients. In the categories below n is the actual number of isolates used to caluculate the MIC 50 and MIC 90."|||mcg/mL|||Number
1269106|NCT00367991|Secondary|Left Ventricular Ejection Fraction||Day 1 and Day 10|These data were not collected due to lack of funds.||||||
1269063|NCT00368537|Secondary|Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit|Microbiological response assessed at patient level. Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for patients with a clinical response of failure; Superinfection=culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|up to 6 weeks|Microbiologically Evaluable patients:CE patients who had baseline culture with ≥1 identified pathogen susceptible to both study drugs (ie, the pathogen is susceptible to tigecycline and comparator). TOC performed 8-50 days after last dose of study drug.|||participants|||Number
1269064|NCT00368537|Secondary|Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit|Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. ME population were subjects who were CE and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|Microbiologically Evaluable patients:Clinically Evaluable (CE) patients who had baseline culture with ≥1 identified pathogen susceptible to both study drugs (ie, the pathogen is susceptible to tigecycline and comparator). Excludes indeterminates.|||participants|||Number
1269065|NCT00368537|Primary|Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit|Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.|up to 6 weeks|Clinically Evaluable (CE): Patients with cSSSI, no Pseudomonas aeruginosa as sole baseline isolate, met major inclusion/exclusion criteria, ≤24 hrs antibiotics pre-baseline, had ≥4 days of study drug, compliant with therapy. Excludes indeterminates.|||participants|||Number
1269066|NCT00368472|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.|Baseline up to week 221|The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.|||Percent responders|||Number
1269067|NCT00368472|Secondary|Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.|Baseline up to Week 221|The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.|||Percent Change||Full Range|Median
1269068|NCT00368472|Primary|Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The data is presented in the safety section of the results.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years|Safety Analysis Set was defined as participants who received at least 1 dose of open-label perampanel and had at least 1 safety assessment after the first dose of perampanel in the OLE study.|||Participants|||Number
1269069|NCT00368459|Secondary|Cognition (Neuropsychological)|Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 6 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
1269070|NCT00368459|Secondary|Behavior|Neuropsychiatric Inventory, change from baseline at 6 months, compared between groups. Range 0-120. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
1269107|NCT00367991|Primary|Platelet Function Assay Closure Time||Change from Day 3 to Day 10|ITT|||seconds||Inter-Quartile Range|Median
1269074|NCT00368459|Secondary|Cognitive (Neuropsychological)|Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 12 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.|12 months||||units on a scale||Standard Deviation|Mean
1269075|NCT00368459|Secondary|Behavior|Neuropsychiatric Inventory, change from baseline at 12 months. Range 0-120. For results below, positive change represents improvement/ better performance.|12 months||||units on a scale||Standard Deviation|Mean
1269076|NCT00368459|Secondary|Function, Activities of Daily Living (ADL)|ADL scale from the Alzheimer's Disease Cooperative Study, change from baseline at 12 months. Range 0-78. For results below, positive change represents improvement/ better performance.|12 months||||units on a scale||Standard Deviation|Mean
1269077|NCT00368459|Secondary|Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes|Global rating of dementia severity, change from baseline at 12 months. Range 0-5. For results below, positive change represents improvement/ better performance.|12 months||||units on a scale||Standard Deviation|Mean
1269078|NCT00368459|Primary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)|"ADAS-cog, change from baseline at 12 months, compared between treatment arms. The ADAS-cog is a neuropsychological battery commonly used in trials of AD patients. Error score range 0-70. For results below, positive change represents improvement/ better performance.~For the primary outcome, as well as for secondary outcomes, the reported p-values reflect the calculated p-values."|12 months|Intent-to-treat|||units on a scale||Standard Deviation|Mean
1269079|NCT00368316|Secondary|Percentage of Efficacy|Percent efficacy is defined as ((disease rate of controls minus disease rate of vaccinees) divided by disease rate of controls) times 100|During 2 years post vaccination||||Percent efficacy||95% Confidence Interval|Mean
1269080|NCT00368316|Secondary|Geometric Mean Immunoglobulin G (IgG) Anti-Lipopolysaccharide (LPS) Levels|Age-related homologous IgG anti-LPS levels|Injections were administered 6 weeks apart and IgG anti-LPS levels determined >2 weeks after second vaccine dose. Each of the 15 sites also took a sample/week randomly chosen, for 2 years of follow up and blood samples from patients with disease||||ELISA units||95% Confidence Interval|Geometric Mean
1269081|NCT00368316|Primary|Number of Participants With Adverse Events|Number of participants with events per vaccine type and dose occuring in >=5% of participants|Monitored for 7 days per participant following each injection for initial group of 500, 2 days for extended study of up to 5500 additional children||||participants|||Number
1269082|NCT00368290|Primary|Cocaine Use as Measured by Urine Drug Screen|The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.|8 weeks||||Percentage of Participants|||Number
1269083|NCT00368290|Primary|Percent of Participants Reporting no Cocaine Craving|Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.|8 weeks||||Percent of participants|||Number
1269084|NCT00368277|Secondary|Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36||Baseline and week 36|Intent to treat (ITT), Last Observation Carried forward (LOCF)|||mm Hg||Standard Error|Least Squares Mean
1269085|NCT00368277|Secondary|Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints|Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg|Weeks 12 and 36|intent to treat (ITT), last observation carried forward (LOCF)|||Percentage of participants|||Number
1269086|NCT00368277|Secondary|Percentage of Patients With Cough||Weeks 12 and 36|Safety population|||Percentage of Participants|||Number
1269087|NCT00368277|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12||Baseline and Week 12|Intent to treat (ITT), Last Observation Carried forward (LOCF)|||mm Hg||Standard Error|Least Squares Mean
1269088|NCT00368251|Secondary|Global Evaluation Score (Investigator) at the End of Treatment Period|The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement).|End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the Global Evaluation Score (I-GES). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.|||percentage of participants|||Number
1269089|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)|The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the Myoclonus Patient Questionnaire (UMRS section 1). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.|||Percent change||Full Range|Median
1269090|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)|The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the stimulus sensitivity score (UMRS section 3). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.|||Percent change||Full Range|Median
1269108|NCT00367991|Primary|Bleeding Time|An integrated measure of in vivo platelet function and tissue hemostasis.|Change from Day 3 to Day 10|ITT|||seconds||Inter-Quartile Range|Median
1269109|NCT00367835|Secondary|Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population|||mmHg||Standard Deviation|Mean
1269110|NCT00367835|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population|||mmHg||Standard Deviation|Mean
1269091|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)|The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.|||Percent change||Full Range|Median
1269092|NCT00368251|Primary|Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)|The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.|||Percent change||Full Range|Median
1269093|NCT00368108|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population|||Hours||95% Confidence Interval|Least Squares Mean
1269094|NCT00368108|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population|||Scores on a Scale||95% Confidence Interval|Least Squares Mean
1269095|NCT00368108|Secondary|Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1269096|NCT00368108|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)|"Patients described themselves in home diaries as OFF, ON without dyskinesias, ON with non troublesome dyskinesias, ON with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor."|Baseline and Week 20|The Intent-to-treat (ITT) Population for diary data consisted of all subjects who were randomized to either perampanel or placebo, had taken at least 1 dose, had a valid, nonmissing Baseline diary measurement and at least 1 valid, non-missing, postbaseline diary measurement at Last Observation Carried Forward (LOCF).|||Hours||95% Confidence Interval|Least Squares Mean
1269097|NCT00368069|Primary|Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population|Number of POS over the treatment period standardized to 1 week period|Treatment Period (12 weeks)|Per Protocol (PP) Population (Analyses were performed on subjects from the PP Population with non-missing information during both baseline and treatment period)|||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
1269098|NCT00368069|Secondary|Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks|The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.|over the treatment period (12 weeks)|ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period).|||Participants|||Number
1269099|NCT00368069|Secondary|50% Response in Weekly POS Frequency|A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period.|Treatment period (12 weeks)|ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period)|||Participants|||Number
1269100|NCT00368069|Secondary|All (Type I+II+III) Seizures Frequency Per Week|Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)|Treatment period (12 weeks)|ITT (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)|||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
1269101|NCT00368069|Secondary|POS Seizure Frequency Per Week Over Baseline and Treatment Period||Baseline Period (8 weeks) - Treatment Period (12 weeks)|ITT Population - no imputation techniques used for missing data (number of subjects with non-missing data for Baseline = ITT Population and for Treatment period = 75 patients for Levetiractam and 78 patients for PBO) Clusters of type I count are included in the count of Type I seizures|||seizures per week||Inter-Quartile Range|Median
1269111|NCT00367835|Secondary|Change From Baseline in Pulse Rate at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population|||beats/min||Standard Deviation|Mean
1269112|NCT00367835|Secondary|Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and up to 8 weeks|Safety population defined as all randomized subjects who received at least one dose of any investigational product during this study.|||msec||Standard Deviation|Mean
1269113|NCT00367835|Secondary|Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)|"The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of strongly agree or agree."|up to 8 weeks|FAS|||Participants|||Number
1269114|NCT00367835|Secondary|Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks|The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1269115|NCT00367835|Secondary|Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks|Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.|Baseline and up to 8 weeks|FAS|||units on a scale||Standard Deviation|Mean
1269116|NCT00367835|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|FAS|||Participants|||Number
1269117|NCT00367835|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|up to 8 weeks|FAS|||Participants|||Number
1269118|NCT00367835|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1269119|NCT00367835|Primary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and up to 8 weeks|Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of any investigational product during this study and with a baseline and at least one post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1269120|NCT00367770|Primary|Number of Participants With a Change in WHO Functional Class|"Number of participants with a change in WHO functional class from baseline to week 24.~A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement."|from baseline to week 24|The analysis was done in the safety set.|||participants|||Number
1269121|NCT00367770|Primary|Change in Borg Dyspnea Index|Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.|from baseline to week 24|The analysis was done in the safety set.|||units on a scale||Standard Deviation|Mean
1269122|NCT00367770|Primary|Change in 6-minute Walk Distance||from baseline to week 24|The analysis was done in the safety set.|||m||Standard Deviation|Mean
1269123|NCT00367744|Secondary|the Change in the Carotid IMT of the Common Carotid Artery|Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|48 weeks|Intention to treat analysis with last observation carried forward if week 48 carotid IMT data was missing and post-baseline IMT data was available|||mm||Inter-Quartile Range|Median
1269124|NCT00367744|Primary|Change in Limb Fat at 48 Weeks|Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|48 weeks|Intention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble.|||grams||Inter-Quartile Range|Median
1269125|NCT00367679|Secondary|Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins|Baseline and post-therapy plasma samples were obtained from participants. Immunohistochemistry analyses were carried out using a BioPlex 200 machine (Bio-Rad) or by enzyme-linked immunoassays to evaluate levels of angiogenesis-related proteins and other relevant proteins. Post- and pre-treatment changes in cytokines and angiogenic factors in response to pazopanib were analyzed. A negative value indicates that the post-treatment level of the particular target protein was less than the pre-treatment level.|Baseline to at least two weeks and at most 6 weeks|Safety population: all participants who received at least one dose of pazopanib. Only 33 of 35 subjects had plasma samples from both pre- and post-treatment available for analysis.|||ratio||Inter-Quartile Range|Median
1269126|NCT00367679|Secondary|Semiquantitative Levels of Staining in Pre-treatment Tumor Biopsies (e.g. VEGF, VEGFR-1,VEGFR-2).|Analysis not performed as part of study. Appropriate material was not available for analysis.|Entire study interval|Safety Population: all participants who received at least one dose of pazopanib|||Relative luminescence units||Standard Deviation|Mean
1269127|NCT00367679|Secondary|Genetic Variations in Germline DNA|Plasma samples were collected from each consenting participant, generally at baseline, to permit evaluation of the presence or absence of genetic variations in select candidate genes in germline DNA. Analyses that could have been done might have examined the relationship between genetic variants and the safety or tolerability or the efficacy of pazopanib. Analyses have not yet been conducted, but a need to do so may yet be identified. The clinical study report indicated that results, if any, would be reported separately.|Baseline|Safety Population: all participants who received at least one dose of pazopanib|||Sum of changes in gene (DNA) sequences||Standard Deviation|Mean
1269128|NCT00367679|Secondary|Plasma Levels of Lactate Dehydrogenase-5 (LDH5)|LDH5 has been shown to be associated with activation of angiogenesis in lung cancer. Circulating levels of LDH5 were to have been measured at each scheduled visit through the post-treatment visit to determine if a correlation with drug effect existed. Levels of LDH5 were measured, but the team determined that greater value was to be derived from transcriptional and plasma biomarker analyses; thus, no analyses were conducted to examine the correlation of LDH5 levels with effects of pazopanib.|Baseline to at least three weeks and at most 8 weeks|Safety Population: all participants who received at least one dose of pazopanib|||Units/Liter||Standard Deviation|Mean
1269129|NCT00367679|Secondary|Intratumoral Levels of Specific Biomarkers|A pre-treatment tumor biopsy from each participant was to have been analyzed by Western blotting to semi-quantitate levels of various proteins related to angiogenesis and/or to the mechanism of action of pazopanib. These assays were not carried out due to insufficient quantity of tissue present in the pre-treatment biopsy (fine needle aspirate). The clinical study report indicates that results were to have been reported separately.|Baseline tumor biopsy|Safety Population: all participants who received at least one dose of pazopanib|||nanograms/milliliter||Standard Deviation|Mean
1269130|NCT00367679|Secondary|Gene Mutations in Pre- or Post-treatment Tumor Biopsies|Specific genes (KRAS, MYC, TP53, and others) were to have been analyzed for the presence or absence of amplifications or deletions and for the presence, absence, and sequence of point mutations in pre- or post-treatment tumor biopsies. These analyses were not conducted because the potential results were considered to provide overlapping information with those obtained in the transcriptional and proteomic profiling assays that were conducted. The clinical study report indicates that genetic measures were to have been reported separately.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Safety Population: all participants who received at least one dose of pazopanib|||Number of DNA sequence changes||Standard Deviation|Mean
1269131|NCT00367679|Secondary|Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes|Gene expression data analysis was performed with GeneSpring GX 7.3.1 (Agilent Technologies). Data were preprocessed using the RMA algorithm. The Benjamini and Hochberg false discovery rate was used for multiple testing corrections. Data below are log-transformed ratios of the post-treatment to pre-treatment expression intensity, indicating the fold increase/decrease in expression of genes. PDGF, platelet-derived growth factor; VEGFR, vascular endothelial growth factor receptor; c-KIT, a protein tyrosine kinase that is a receptor for stem cell factor or “kit” ligand.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Tumor tissue from Safety Population: all participants who received at least one dose of pazopanib. Only 26 of 35 subjects had sufficient tissue in both pre- and post-treatment samples for analysis.|||ratio||Standard Deviation|Median
1269132|NCT00367679|Secondary|Number of Cells Exhibiting Apoptosis in Participant Samples|Tumor cells from pre-treatment and post-operative biopsies were to have been analyzed to determine the number of cells that were exhibiting apoptosis. Due to the limited quantity of tissue in pre- and post-treatment biopsy samples, these assays were not performed.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Tissue from Safety Population: all participants who received at least one dose of pazopanib|||number of cells||Standard Deviation|Mean
1269133|NCT00367679|Secondary|Number of Participants With the Indicated Change From Baseline in Systolic and Diastolic Blood Pressure|Increases in systolic or diastolic blood pressure values at any point in the study following baseline were summarized. mmHg = millimeters of mercury. Baseline blood pressure values as well as the change from baseline experienced are given in the category titles.|Baseline to at least three weeks and at most 8 weeks|Safety Population|||participants|||Number
1269134|NCT00367679|Secondary|Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values|Shifts in chemistry values by grade were summarized based on the NIH Common Terminology Criteria for Adverse Events (Version 3.0 – definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here. ULN = upper limit of normal; Gr = grade; mg = milligrams; dL = deciliter; mmol = millimoles.|Baseline to at least three weeks and at most 8 weeks|Safety Population|||participants|||Number
1269135|NCT00367679|Secondary|Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values|Shifts in hematology values by grade were summarized based on the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (Version 3.0 – definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here.|Baseline to at least three weeks and at most 8 weeks|Safety Population|||participants|||Number
1269136|NCT00367679|Secondary|Number of Participants Achieving a >=60% Reduction in Tumor Metabolic Activity Determined as Standard Uptake Value (SUV)|Response is the number of participants whose tumor demonstrated a 60% or greater reduction in metabolic activity (SUV) as measured by positron emission tomography (PET) or PET/computed tomography (PET/CT) at the end of treatment visit relative to baseline. This analysis was not conducted because insufficient data were collected: only three participants had PET/CT data.|Baseline to at least two weeks or at most six weeks|Safety Population: all participants who received at least one dose of pazopanib|||participants|||Number
1269137|NCT00367679|Secondary|Number of Participants Achieving a Clinical Response Based on RECIST|Response is the number of participants achieving either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes not meeting previously given criteria. Confirmation requires at least 2 assessments (conducted by a central reviewer) of CR/PR with at least 4 weeks between the assessments.|Baseline to at least two weeks or at most six weeks|Safety population: all participants who received at least one dose of pazopanib|||participants|||Number
1269161|NCT00367133|Secondary|Change in Central Subfield Thickness on OCT Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Microns||Inter-Quartile Range|Median
1269138|NCT00367679|Primary|Number of Participants Achieving Tumor Shrinkage Based on Change in Tumor Volume|"Tumor shrinkage was assessed as the change in tumor volume using high-resolution computed tomography scans of the thorax following treatment with pazopanib. Response is defined as the number of participants achieving at least 50% tumor volume reduction following pazopanib treatment. Responder is a participant whose tumor volume reduced at least 50% following pazopanib treatment. Non-responder is a participant whose tumor volume did not reduce at least 50% following treatment. Tumor assessments were conducted by a central reviewer."|Baseline to at least two weeks or at most six weeks|Safety Population: all participants who received at least one dose of pazopanib|||participants|||Number
1269139|NCT00367640|Primary|Average Rhinoconjunctivitis Total Symptom Score|"Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.~Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome."|Pollen period (average of 32 days in the ITT set)|The intent-to-treat (ITT) population included all patients who received at least one dose of investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.|||Units on a scale (range: 0 to 18)||Standard Deviation|Mean
1269140|NCT00367601|Secondary|Overall Survival||12 months||||months||95% Confidence Interval|Median
1269141|NCT00367601|Secondary|Time to Progression||12 months||||months||95% Confidence Interval|Median
1269142|NCT00367601|Primary|To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician||4 months||||percentage of participants|||Number
1269143|NCT00367484|Primary|Number of Participants Testing Positive for Neutralising Antibody (NAb)|Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.|48 Weeks|Intent To Treat (ITT) population, Last Observation Carried Forward (LOCF)|||NAb+ participants|||Number
1269144|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B):~[ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Other types of Seizures are all seizures except Partial Seizures (Type 1)."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Other Types of Seizures.|||Percent Reduction||Inter-Quartile Range|Median
1269145|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A):~[ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple and Complex Partial Seizures.|||Percent Reduction||Inter-Quartile Range|Median
1269146|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in secondary generalized seizure frequency is given as a percent reduction computed as:~[ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100.~Positive values in reduction means the value decreased from Baseline during the first 16-week Period.~Secondary generalized seizures belong to one of the 3 groups:~Simple partial sz evolving to gen sz~Complex partial sz evolving to gen sz~Simple partial sz evolving to Complex partial sz evolving to gen sz"|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Secondary Generalized Seizures.|||Percent Reduction||Inter-Quartile Range|Median
1269147|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in complex partial seizure frequency is given as a percent reduction computed as:~[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Complex Partial Seizures.|||Percent Reduction||Inter-Quartile Range|Median
1269162|NCT00367133|Secondary|Change in Central Subfield Thickness on OCT Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Microns||Standard Deviation|Mean
1269148|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in simple partial seizure frequency is given as a percent reduction computed as:~[ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple Partial Seizures.|||Percent Reduction||Inter-Quartile Range|Median
1269149|NCT00367432|Secondary|Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)|"The percent reduction from Baseline was computed as:~[ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100.~Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Full Analysis Set (FAS).|||Participants|||Number
1269150|NCT00367432|Secondary|Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study|Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.|First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)|Full Analysis Set (FAS).|||Seizures Per Week||Inter-Quartile Range|Median
1269151|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study|"The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as:~[ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Full Analysis Set (FAS).|||Percent Reduction||Inter-Quartile Range|Median
1269152|NCT00367432|Primary|Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)|"An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product.~Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE."|During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted|Safety Set includes all subjects from N01221 [NCT00280696] and N01020 [NCT00160615] administered the investigational products at least once.|||participants|||Number
1269153|NCT00367380|Primary|Infection for P. Vivax|Thick blood smear was performed to patients daily on days 7 to 23, and every other day until day 29. Any prove of P. vivax infection was considered positive and confirmed later by real time polymerase chain reaction (rPCR).|Twenty eight days||||days||Standard Deviation|Mean
1269154|NCT00367341|Secondary|Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks|Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score|Measured at week 12.|completers|||participants|||Number
1269155|NCT00367341|Primary|Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks|# of study participants with Hamilton Depression-17-item score less than or equal to 7.|Measured at week 12|completed study participants in 12-week-trial|||participants|||Number
1269156|NCT00367237|Secondary|Adverse Events|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16|||||||
1269157|NCT00367237|Secondary|Change in Disease Activity Score, Each of the ACR20 Domains, Dactylitis, Enthesitis, Fatigue and Duration of Morning Stiffness, Erythrocyte Sedimentation Rate, and Disability Index of the Health Assessment Questionnaire (HAQ)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16|||||||
1269158|NCT00367237|Secondary|Proportion of Subjects Achieving ACR50, ACR70, and PASI75 if Applicable|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16|||||||
1269159|NCT00367237|Primary|Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16|>=20% improvement in swollen and tender joint count AND >=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.|between baseline and week 16|Number of subjects from Intent-to-Treat population in each arm at Week 16|||participants|||Number
1269160|NCT00367133|Secondary|Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Percentage of Eyes|||Number
1269177|NCT00367055|Secondary|Mean Change From Baseline in CPP Total and Incremental AUC T0-T30 After a 36-month Treatment||Baseline and Month 36|||||||
1269163|NCT00367133|Secondary|Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Microns||Inter-Quartile Range|Median
1269164|NCT00367133|Secondary|Distribution of Visual Acuity Change Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Percentage of Eyes|||Number
1269165|NCT00367133|Secondary|Change in Visual Acuity From Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0|Baseline to 3 year|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Letter Score||Inter-Quartile Range|Median
1269166|NCT00367133|Secondary|Change in Visual Acuity From Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.|Baseline to 3 year|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Letter Score||Standard Deviation|Mean
1269167|NCT00367133|Secondary|Central Subfield Thickness < 250 Microns at 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|2 Years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.|||Percentage of Eyes|||Number
1269168|NCT00367133|Secondary|Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|Baseline to 2 Years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.|||Percentage of Eyes|||Number
1269169|NCT00367133|Secondary|Median Change in Central Subfield Thickness Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 2 Years|Only subjects with an available OCT's at baseline and 2 years are included in the OCT analysis.|||Microns||Inter-Quartile Range|Median
1269170|NCT00367133|Secondary|Mean Change in Central Subfield Thickness Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.|Baseline to 2 years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.|||Microns||Standard Deviation|Mean
1269171|NCT00367133|Primary|Distribution of Change in Visual Acuity Baseline to 2 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|baseline to 2 years|The primary analysis included all randomized eyes and followed the intent-to-treat principle|||Percentage of Eyes|||Number
1269172|NCT00367133|Primary|Median Change in Visual Acuity Baseline to 2 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.|Baseline to 2 Years|The primary analysis included all randomized eyes and followed the intent-to-treat principle.|||Letter score||Inter-Quartile Range|Median
1269173|NCT00367133|Secondary|Central Subfield Thickness at 2 Years|Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|2 Years|Only subjects with an available Optical coherence tomography (OCT) at baseline and 2 years are included in the OCT analysis.|||Microns||Inter-Quartile Range|Median
1269174|NCT00367133|Primary|Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 2 Years|The primary analysis included all randomized eyes and followed the intent-to-treat principle.|||Letter score||Standard Deviation|Mean
1269175|NCT00367055|Secondary|Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36|Change from baseline was calculated as the Month 18 and 36 values minus the baseline value. Insulin sensitivity is measured as the quantity of glucose metabolized per unit of plasma insulin concentration.|Baseline and Months 18 and 36|ITT Population|||micromoles (umol)/kilogram/min/pmol/L||Standard Deviation|Mean
1269176|NCT00367055|Secondary|Mean Change From Baseline in CPP Concentration Peak and Incremental Concentration Peak T0-T30 After a 36-month Treatment||Baseline and Month 36|||||||
1269180|NCT00367055|Secondary|Mean Change From Baseline in FBG at Month 36|Change from baseline was calculated as the Month 36 value minus the baseline value. FBG levels were measured by blood draw.|Baseline and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1269181|NCT00367055|Secondary|Mean Change From Baseline in HbA1c at Month 36|Change from baseline was calculated as the Month 36 value minus the baseline value. HbA1c levels were measured by blood draw.|Baseline and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.|||percent change||Standard Deviation|Mean
1269182|NCT00367055|Secondary|Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment|Change from baseline was calculated as the Month 18 value minus the baseline value. Insulin secretion capacity is measured in blood (blood level of insulin) and is a response of the pancreatic beta-cells to hyperglycemia induced by a glucose IV bolus, then infusion. Hyperglycemic clamp (HC) is a reference technique to evaluate the initial and the secondary phases of insulin secretion.|Baseline and Month 18|"Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different ns for each category."|||pmol/L*min||Full Range|Median
1269183|NCT00367055|Secondary|Median Change From Baseline in the Ratio M/I After a 36-month Treatment||Baseline and Month 36|||||||
1269184|NCT00367055|Primary|Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment|Change from baseline in the insulin secretory capacity was measured by the assesment of blood insulin concentrations (conc.) using the hyperglycaemic clamp (HC) technique, per intravenous glucose perfusion by a catheter. Change from baseline for insulin conc peaks (highest conc level) was calculated as the Month 36 value minus the baseline value. Insulin secretion was assessed by calculating AUC during the first 10 minutes of HC (incremental and total AUC0-10 min) and the AUC after the first 10 minutes of the HC (10-180min).|Baseline and Month 36|"Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different ns for each category."|||picomoles/L per minute (pmol/L*min)||Full Range|Median
1269185|NCT00366899|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after toddler dose (12 months of age)|Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1269186|NCT00366899|Secondary|Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose|Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (12 months of age)|Evaluable pneumococcal immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1269187|NCT00366899|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)|Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1269188|NCT00366899|Primary|Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose|Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)|The evaluable pneumococcal immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1269189|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of Polio as measured using a polio in vitro plaque neutralization.|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||Titers||95% Confidence Interval|Geometric Mean
1269250|NCT00366249|Secondary|Number of Patients With Microbiologic Response of Eradication.|Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Microbiologically evaluable population without osteomyelitis.|||patients|||Number
1269190|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
1269191|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1269192|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose|GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.|One month after the infant series (6 months of age) and the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.|||mIU/mL||95% Confidence Interval|Number
1269193|NCT00366899|Other Pre-specified|Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 and after the toddler dose|OPAS were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group|||Titers||95% Confidence Interval|Geometric Mean
1269194|NCT00366899|Other Pre-specified|Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose|Percentage of subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. (This is not a geometric mean comparison as suggested by the table row heading).|one month after infant series dose 2 and after the toddler dose|OPAs were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group|||% Achieving OPA Titer ≥1:8||95% Confidence Interval|Geometric Mean
1269195|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
1269196|NCT00366899|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose|Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.|One month after the infant series (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant antibody concentration/titer for the given concomitant antigen.|||percentage of participants||95% Confidence Interval|Number
1269197|NCT00366899|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
1269198|NCT00366899|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
1269199|NCT00366678|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|One month after the 3-Dose Infant Series (at 5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1269200|NCT00366678|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
1269201|NCT00366678|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
1269202|NCT00366678|Primary|Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the 3-Dose Infant Series (at 5 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Geometric Mean
1269203|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||EU/mL||95% Confidence Interval|Number
1269204|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Number
1269205|NCT00366678|Primary|Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Number
1269206|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
1269207|NCT00366678|Secondary|Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose|GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1269208|NCT00366678|Secondary|Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
1269209|NCT00366678|Secondary|Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups|Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1269210|NCT00366678|Secondary|Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups|Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||percentage of participants||95% Confidence Interval|Number
1269211|NCT00366678|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group|Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.|One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1269212|NCT00366626|Primary|Limited Access Alcohol Consumption Paradigm; Total Number of Drinks Consumed|Subjects were allowed to drink up to 8 alcohol drinks during 2 hours observation period being in bar/laboratory settings vs to get $2 per each not consumed drink.|On day 7 of treatment during limited access alcohol consuption in the bar/laboratory|All subjects who were randomized.|||Total number of drinks consumed||Standard Deviation|Mean
1269213|NCT00366626|Primary|"Natural Alcohol Consumption Period; Average Number of Drinks Per Day Consumed During the 5 Day Natural (Usual Environment) Drinking Observation Period"||treatment days 1 - 5|All subjects who were randomized.|||Drinks per day||Standard Deviation|Mean
1269214|NCT00366548|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 13 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1269215|NCT00366548|Primary|Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (at 5 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1269216|NCT00366548|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4-days after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
1269217|NCT00366548|Other Pre-specified|Percent of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4-days after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
1269218|NCT00366548|Secondary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 13 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1269219|NCT00366548|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (at 5 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1269220|NCT00366535|Primary|Fibromyalgia Impact Questionnaire|The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item self-administered measure to assess 3 areas of fibromyalgia (FM): function, overall impact, and symptoms. The total FIQ score was the primary outcome of the study. The total FIQ score is the sum of the 3 areas measured in the FIQ. The maximum possible total FIQ score is 100, with a minimum score of 10. The average FM patient scores about 50, severely afflicted FM patients are usually 70 and above. Data analysis is ongoing from data collected from study completers.|25 weeks|Total 56 patients enrolled, and 39 patients completed the study. 17 patients withdrawn from the study. Three of 39 patients were excluded from the data analysis because there had missing FIQ scores at Baseline and/or Week 12. The data from the study of the 36 participants with complete data sets was analyzed.|||units on a scale||Standard Deviation|Mean
1269221|NCT00366457|Secondary|Overall Survival|overall survival (OS) = time from study entry until death from any cause|5 years|participants who started treatment|||months||95% Confidence Interval|Median
1269223|NCT00366457|Secondary|Response Rate|Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|after at least one 28-day cycle of treatment|participants with response data available|||Participants|||Count of Participants
1269224|NCT00366457|Primary|Time to Tumor Progression|"Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|all patients will be followed for a minimum of 4 months|participants who started treatment|||months||95% Confidence Interval|Median
1269225|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 3|Day 3 data reflect the use of rescue medication only up to the time of discharge|Day 3||||participants|||Number
1269226|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 2||Day 2||||participants|||Number
1269227|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 1||Day 1||||participants|||Number
1269228|NCT00366444|Secondary|Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|"Number of participants analyzed includes only the number of participants with at least a 30% reduction in pain intensity after the 1st dose (see previous outcome measure, #7).~Number of placebo patients is intentionally blank as the data (eg., upper CI) was not calculable."|||minutes||95% Confidence Interval|Median
1269229|NCT00366444|Secondary|Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose||||participants|||Number
1269230|NCT00366444|Secondary|Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug|Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.|8 hours post single dose||||units on a scale||Standard Deviation|Mean
1269231|NCT00366444|Secondary|Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1||8 hours post single dose|"Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure, #4).~Number of patients in the placebo group is intentionally blank as the data was not calculable since less than 50% of the patients reported meaningful relief (ie, median cannot be calculated)."|||minutes||95% Confidence Interval|Median
1269232|NCT00366444|Secondary|Number of Patients With Meaningful Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose||||participants|||Number
1269233|NCT00366444|Secondary|Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1||8 hours post single dose|Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous Outcome Measure #2)|||minutes||95% Confidence Interval|Median
1269234|NCT00366444|Secondary|Number of Patients With Perceptible Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose||||participants|||Number
1269235|NCT00366444|Primary|Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy|Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain|Over 48 hours after bunionectomy||||units on a scale||Standard Deviation|Mean
1269236|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1269237|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
1269238|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, included participants who received given dose; (n) = number of participants reporting the specific characteristic.|||percentage of participants|||Number
1269239|NCT00366340|Primary|Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose|Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|Immediately before (12 months of age) and one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody concentration for the specified concomitant antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
1269240|NCT00366340|Primary|Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.|||mIU/mL||95% Confidence Interval|Geometric Mean
1269241|NCT00366340|Primary|Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose||One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
1269242|NCT00366340|Primary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose||One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
1269243|NCT00366340|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose|Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).|One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a antibody concentration ≥ the prespecified level for the given concomitant antigen.|||Percentage of Participants||95% Confidence Interval|Number
1269244|NCT00366340|Primary|Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
1269245|NCT00366340|Primary|Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.|Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1269246|NCT00366340|Primary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1269247|NCT00366340|Primary|Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
1269248|NCT00366301|Primary|Percentage Reduction in C-reactive Protein (CRP)||14 weeks|As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. Any subject having either or both 6 week and 14 week measures was included.|||Percent CRP Reduction||95% Confidence Interval|Mean
1269249|NCT00366275|Primary|Progression-free Survival|"PFS is calculated according to the Kaplan-Meier estimator. The observation time of each subject is defined as the time from entry into the study until lymphoma progression or death as a result of any cause whichever occurs first.~The 5-year PFS is the estimated cumulative probability of surviving at least 5 years without progression."|every 3 months for the first year after autotransplant and every 6 months after the first year of follow up||||percent chance of PFS at 5 years||95% Confidence Interval|Number
1269251|NCT00366249|Secondary|Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.|Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose|Clinical modified intent to treat population with osteomyelitis.|||patients|||Number
1269252|NCT00366249|Primary|Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Clinical modified intent to treat population without osteomyelitis.|||patients|||Number
1269253|NCT00366249|Secondary|Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.|Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose|Clinically evaluable population with osteomyelitis.|||patients|||Number
1269254|NCT00366249|Primary|Number of Patients With Clinical Response of Cure Vs. Failure.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Clinically evaluable population without osteomyelitis.|||patients|||Number
1269255|NCT00366106|Secondary|Relative Dose Intensity of Bortezomib|Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.|Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)|Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.|||Relative dose intensity||Standard Deviation|Mean
1269256|NCT00366106|Secondary|Number of Participants With Treatment Response|Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and <5% plasma cells in bone marrow. PR also required >=50% SPEP reduction, >=90% UPEP reduction, and >=50% reduction in plasma cells in bone marrow. MR also required >=25% SPEP reduction, >=50% UPEP reduction, and > 25% reduction in plasma cells.|Every 8 weeks from start of treatment until end of treatment||||Participants|||Number
1269257|NCT00366106|Secondary|Time to Progression (TTP)||TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months||||Months||Standard Deviation|Mean
1269258|NCT00366106|Primary|Incidence of Treatment-emergent Peripheral Neuropathy||Every 4 weeks from start of treatment until end of treatment||||Participants|||Number
1269259|NCT00366028|Primary|Effect Size of Improvement in Hand Hygiene Compliance|The effect size of improvement in hand-hygiene compliance was calculated by comparing the baseline three-month periods to the last three-month periods of the study. To evaluate the statistical significance of changes in proportion adherence over time, we ran a weighted least squares regression model with time (i.e. month) as the independent variable and adherence proportion as the dependent variable. The sample size in each data collection period was used as the weight. Our interest is in the statistical significance of the coefficient associated with time. To evaluate the practical significance of the change pre and post intervention, we examined the effect size associated with the change in proportion adherence in the first 3-month period of data collection and the last 3-month period. Effect size was calculated as 2*arcsin(sqr(p2)) - 2*arcsin(sqr(p1)). Using Cohen's criteria, an effect size of .2 is interpreted as small, .5 as medium and .8 as large.|3 months pre and post study intervention|This outcome measure was only assessed at the site (facility) level.|||effect size|Participants||Number
1269260|NCT00366028|Primary|Fidelity to the Organizational Model|"Final fidelity to the Organizational Model was assessed by averaging scores for each component of the model. Scores ranged from 0 (no evidence of that factor present) to 4 (factor fully present and used as intended). The 3 main components of the model included 1) active leadership commitment to quality, 2) robust clinical process redesign to incorporate evidence-based practices into routine operations, and 3) use of management structures and processes to support and align redesign. Scores for each component of the model were measured by the study team using structured rating instruments based on data collected during interviews.~Sites with an overall fidelity score above 3.0 were considered to have high fidelity to the organizational model."|Fidelity was assessed at the end of the 3 year study.|This outcome measure was only assessed at the site (facility) level.|||units on a scale|Participants||Number
1269261|NCT00365976|Secondary|State-Trait Anxiety Inventory (STAI)|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)|Baseline, week 1, week 2, week 4|Data not collected.||||||
1269262|NCT00365976|Secondary|Short Form 36 Health Survey Questionnaire (SF-36)|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).|Baseline, week 1, week 2, week 4|Data not collected.||||||
1269263|NCT00365976|Secondary|Hamilton Depression Rating Scale (HAM-D-24)|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4||||units on a scale||Standard Deviation|Mean
1269264|NCT00365976|Secondary|Roland Morris Low Back Pain Inventory (RMLBPI)|"The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 “yes-no” items assessing potential disabilities.~Scores range from 0 (no disability) to 24 (severe disability)."|prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4||||units on a scale||Standard Deviation|Mean
1269266|NCT00365976|Secondary|Insomnia Severity Index (ISI)|The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0–28: 0–7 (no clinical insomnia), 8–14 (subthreshold insomnia), 15–21 (insomnia of moderate severity), and 22–28 (severe insomnia).|Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4||||units on a scale||Standard Deviation|Mean
1269267|NCT00365976|Secondary|Sleep Quality Ratings|Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep|Postnaprosyn Baseline, Week 1, Week 2 week 4||||units on a scale||Standard Deviation|Mean
1269268|NCT00365976|Secondary|Number of Awakenings||Postnaprosyn Baseline, Week 1, Week 2 week 4||||awakenings||Standard Deviation|Mean
1269269|NCT00365976|Secondary|Wake Time After Sleep Onset||Postnaprosyn Baseline, Week 1, Week 2 week 4||||minutes||Standard Deviation|Mean
1269270|NCT00365976|Secondary|Mean Sleep Onset Latency (SOL)||Postnaprosyn Baseline, Week 1, Week 2 week 4||||minutes||Standard Deviation|Mean
1269271|NCT00365976|Secondary|Visual Analog Scale Pain Ratings (VAS)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain|Postnaprosyn baseline, Week 1, Week 2, Week 4||||units on a scale||Standard Deviation|Mean
1269272|NCT00365976|Primary|Mean Subjective Sleep Diary Derived Total Sleep Time (TST)|Nightly total sleep time was averaged from diary entries.|Postnaprosyn baseline, Week 1, week 2, week 4||||Minutes||Standard Deviation|Mean
1269273|NCT00365872|Other Pre-specified|Number of Participants With Increase in Level of Radioactivity at Excision Per Cohort|To identify the nodes to be excised, an injection with Indium 111 (radio active dye) labeled dendritic cells (of vaccine #4) was performed 1 to 3 days prior to surgery. Patients were evenly divided to be assigned to one of three cohorts: Cohort 1, 1 day before surgery; Cohort 2, 2 days before surgery; Cohort 3, 3 days before surgery. Vaccine #4 was labeled in order to evaluate how long dendritic cells need to travel to regional draining lymphatics. Tumor resection was not delayed by this.|Up to 3 years|Participants evaluable for this measure|||participants|||Number
1269274|NCT00365872|Secondary|Participants With No Evidence of Disease at Follow-up|Participants who had no evidence of the disease for at least one year after the start of the treatment (time of follow-up); for at least 2 years, and for at least 3 years.|3 years|All evaluable participants available for follow-up at time of analysis.|||participants|||Number
1269275|NCT00365872|Secondary|Occurrence of Postoperative Wound Complications|Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC).|Up to 3 years|All evaluable participants available for follow-up at time of analysis.|||participants|||Number
1269276|NCT00365872|Secondary|Occurrence of Significant (>/= Grade 2) Toxicity|Toxicity assessment during combination external beam radiation therapy (EBRT)/DC neoadjuvant treatment. Toxicity was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria.|Up to 3 years|All evaluable participants available for follow-up at time of analysis.|||participants|||Number
1269277|NCT00365872|Primary|Overall Response Rate (ORR)|Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment.|Up to 3 years|All evaluable participants available for follow-up at time of analysis.|||participants|||Number
1269278|NCT00365859|Secondary|Change From Baseline in Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF)|CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 96 patients did not have post-baseline evaluations for CY-BOCS, and were excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
1269279|NCT00365859|Secondary|Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF|||units on a scale||Standard Deviation|Mean
1269280|NCT00365859|Secondary|Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.|||units on a scale||Standard Deviation|Mean
1269281|NCT00365859|Secondary|Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.|||units on a scale||Standard Deviation|Mean
1269282|NCT00365859|Secondary|Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF.The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.|||units on a scale||Standard Deviation|Mean
1269283|NCT00365859|Secondary|Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.|||units on a scale||Standard Deviation|Mean
1269284|NCT00365859|Secondary|CGI-Improvement Score at Week 52 (Endpoint, LOCF)|CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement.|Week 52 (Endpoint, LOCF)|Efficacy Sample. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.|||units on a scale||Standard Deviation|Mean
1269285|NCT00365859|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF)|CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.|||units on a scale||Standard Deviation|Mean
1269286|NCT00365859|Primary|Mean Change From Baseline By Time Period in BMI Z-Score|The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.|||Standard Deviations away from Population||Standard Deviation|Mean
1269287|NCT00365859|Primary|Mean Change From Baseline in Patient Body Mass Index (BMI)|The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height.|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample: Endpoint - Last Observation Carried Forward (LOCF)|||kg/m2||Standard Deviation|Mean
1269288|NCT00365859|Primary|Mean Change From Baseline by Time Period in Body Weight Z-Score|The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.|||Standard Deviations away from Population||Standard Deviation|Mean
1269290|NCT00365859|Primary|Number of Potentially Clinically Relevant Vital Sign Abnormalities|Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample|||Participants|||Number
1269291|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities|"These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = to"|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample|||Participants|||Number
1269292|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities|Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample|||Participants|||Number
1269293|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities|Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample|||Participants|||Number
1269294|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities|Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males)|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample|||Participants|||Number
1269295|NCT00365859|Primary|Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
1269296|NCT00365859|Primary|Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
1269297|NCT00365859|Primary|Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
1269298|NCT00365859|Primary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs|Safety Population|||Participants|||Number
1269299|NCT00365846|Secondary|Kidney Allograft Survival||3 years||||participants|||Number
1269300|NCT00365846|Secondary|Incidence of Malignancies|Number of Participants Experiencing Malignancies|3 years||||participants|||Number
1269301|NCT00365846|Secondary|Incidence of Post-transplant Infection|"Event of post-transplant infection (more than one event might have been counted per participant)"|3 years||||event of infection|||Number
1269307|NCT00365716|Secondary|Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)||Through 36 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at Day 1 and PCR negative through Month 7 to the relevant HPV type, and must provide follow-up data after Month 7|||Incidence per 100 person-years|||Number
1269308|NCT00365716|Primary|Number of Subjects With Injection Site Adverse Experiences||Days 1-5 following any vaccination visit|All vaccinated subjects with adverse experience follow-up.|||Participants|||Number
1269309|NCT00365599|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|4 years, 7 months|All participants|||participants|||Number
1269310|NCT00365599|Secondary|Time to Progression (TTP)|The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 30 months|All participants|||months||Full Range|Median
1269311|NCT00365599|Primary|Number of Participants With Objective Response (OR)|The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.|24 weeks|All participants|||participants|||Number
1269312|NCT00365547|Secondary|Median Overall Survival|Defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.|From Day 1 Until Death Occurred|Maximum number of days was 1349.|||Days||95% Confidence Interval|Median
1269313|NCT00365547|Secondary|Median Duration of Response|Defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to progressive disease. For subjects who do not progress or die, duration of response will be censored at the time of last contact.|Day of 1st Response Until Disease Progression of Death/Last Contact|Maximum number of days was 1277.|||Days||95% Confidence Interval|Median
1269314|NCT00365547|Secondary|Median Time to Response|Defined as the time from the start of treatment until first documented evidence of at least a partial tumor response.|From Day 1 Until Tumor Response|Maximum number of days for analysis was 104.|||Days||95% Confidence Interval|Median
1269315|NCT00365547|Secondary|Number of Tumor Responders|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).|From Day 1 Until Disease Progression or Date of Death (Whichever Occurred First), Up to 1 Year||||Participants|||Number
1269316|NCT00365547|Primary|Median Time to Disease Progression|Assessed by Response Evaluation Criteria In Solid Tumor (RECIST criteria). Progression is defined as a measureable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions since baseline.|From Day 1 Until First Documented Disease Progression or Date of Death (Whichever Occurred First)|All intent-to-treat patients enrolled were analyzed. Maximum number of days was 1349.|||Days||95% Confidence Interval|Mean
1269317|NCT00365508|Secondary|Rate of Compliance During the First 2 Weeks|Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence|2 weeks|Intent to treat|||participants|||Number
1269318|NCT00365508|Primary|24-hour Point Prevalence Abstinence at the 6-month Follow up||6-months|Intent to treat analysis (lost to follow-up = smoker)|||participants|||Number
1269319|NCT00365456|Primary|Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.|BMD was measured by Dual X-ray Absorptiometry (DXA).|12 months|All randomized patients made the Full Analysis Set which was used for the primary and secondary analyses according to intention-to-treat principles. One participant excluded due to missing baseline data at trial period III entry, thus no data could be carried forward for this patient. Missing values imputed by Last Observation Carried Forward.|||Percentage Change||Standard Error|Least Squares Mean
1269320|NCT00365417|Secondary|Percentage of Surgical Complications Defined as Wound Dehiscence, Infection, Seroma, Hematoma||Two (2) years|||||||
1269321|NCT00365417|Secondary|Overall Survival|Time from the first dose of study therapy until date of death|From the first dose of study therapy until the date of death or for a maximum of 24 months from study entry|||||||
1269322|NCT00365417|Secondary|Progression-free Survival|Time from the first dose of study therapy to disease progression|From the first dose of study therapy until the date of disease progression or for a maximum of 24 months from study entry|||||||
1269323|NCT00365417|Secondary|Cardiac Events|Events: Congestive Heart Failure; Cardiac Death|Assessments throughout; up to 18 months following study entry|||||||
1269324|NCT00365417|Secondary|Reported Adverse Events||Assessments throughout; final adverse event assessment is 30 days after the last dose of bevacizumab||||events|||Number
1269325|NCT00365417|Secondary|Clinical Response Rate (cRR) of the Sequential Regimen|Measured by physical exam of the breast and axilla|Assessments at baseline, between the two chemotherapy regimens and following the last cycle of chemotherapy (before surgery)|||||||
1269326|NCT00365417|Secondary|pCR in the Breast and Nodes|Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel nodes|Assessed at the time of surgery||||participants|||Number
1269327|NCT00365417|Primary|Pathologic Complete Response (pCR) in the Breast|Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen|Assessed at the time of surgery||||participants|||Number
1269328|NCT00365391|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.|From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.|All 27 patients were used in this analysis.|||months||95% Confidence Interval|Median
1269329|NCT00365391|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented.|The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|No patients were analyzed for this secondary outcome due to insufficient data.||||||
1269330|NCT00365391|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. Estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, up to 3 years after treatment.|All 27 patients were included in the analysis.|||months||95% Confidence Interval|Median
1269331|NCT00365391|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, patients are followed up to 3 years after treatment|All 27 patients were analyzed.|||months||95% Confidence Interval|Median
1269332|NCT00365391|Primary|Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR).|Responses to erlotinib and bevacizumab treatment were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters.|Patients were able to continue treatment indefinitely and were evaluated every cycle until discontinued treatment.|Four patients were inevaluable because they were off the study prior to first radiologic evaluation for objective response.|||participants|||Number
1269333|NCT00365378|Primary|Serum Anti-HPV 16 Geometric Mean Titers|"The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as 6.0."|Month 7|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR negative to HPV 16 through Month 7, and must provide serology data at Month 7|||milliMerck units/ml (mMU/ml)||95% Confidence Interval|Geometric Mean
1269334|NCT00365378|Primary|Incidence of HPV 16-related CIN1, CIN2 or C1N3|Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.|Through Month 48|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR negative to HPV 16 through Month 7, and must provide follow-up data after Month 7|||Incidence per 100 person-years|||Number
1269335|NCT00365378|Primary|Incidence of Persistent HPV 16 Infection|Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.|Through Month 48|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR (Polymerase chain reaction) negative to HPV 16 through Month 7, and must provide follow-up data after Month 7|||Incidence per 100 person-years|||Number
1269336|NCT00365365|Secondary|Disease-free Survival (DFS) Rate|"DFS was defined as the time from the administration of the first-dose of study medication until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. DFS rate was the probability of being disease free and alive at a particular time. DFS rates were estimated using Kaplan-Meier Method, and 95% confidence intervals were computed using the method of Kalbfleisch and Prentice.~For participants who did have objective recurrence of tumor and who were still on study at the time of an analysis, or who were given antitumor treatment other than the study treatment, or who were removed from study follow-up prior to documentation of the tumor recurrence, DFS was censored at the last date the participant was known to be disease-free."|from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months|Intent-to-treat population - All randomized participants|||percentage of participants|Participants|95% Confidence Interval|Number
1269337|NCT00365365|Secondary|Safety - Number of Participants With Adverse Events (AE)|"An adverse event was any untoward medical occurrence in a participant of the clinical investigation, regardless of the relationship to study treatment.~A serious adverse event (SAE) was an AE that at any dose (including overdose) resulted in death, was life-threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect, and/or was medically important.~Treatment-emergent adverse events (TEAE) were defined as AEs that developed or worsened in severity during the on-treatment period."|from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.|Safety population - participants who received at least one dose of study medication|||participants|||Number
1269338|NCT00365365|Primary|Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)|"Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy.~Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF."|from the first dose of study medication up to the end of follow-up (up to 3 yrs)|Safety population - participants who received at least one dose of study medication|||participants|||Number
1269339|NCT00365352|Secondary|Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)|The time to onset of the first RLS symptoms from the 24-hour RLS Record is defined as the length of time from the start of the 24-hour assessment period (8:00 AM) to the time when 50% of participants experienced their first symptom.|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||hours||95% Confidence Interval|Median
1269340|NCT00365352|Secondary|Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)|RLS severity ratings were summarized in 6 non-overlapping 4-hour periods beginning at 8 AM. A 4-hour period from 6 PM to 10 PM was also prospectively included to reflect the time frame when the most participants would experience their first symptoms of the day.|Week 12|MITT Population. The number analyzed represents participants within the MITT Population who reported no RLS symptoms at the end of Week 12.|||participants|||Number
1269341|NCT00365352|Secondary|Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF|The Restless Legs Syndrome Quality of Life (RLS-QoL) questionnaire is a disease-specific, participant-rated questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life of the participants. The RLS-QoL Questionnaire is presented on a 0 (lowest possible score) to 100 (highest possible score) scale. It was completed at Day 1 and at the end of Weeks 4, 8, and 12 (or Early Termination).|Baseline and Week 12|MITT Population: The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269342|NCT00365352|Secondary|Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep quantity domain were measured in time (number of hours of sleep each night). The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||hours||Standard Deviation|Mean
1269343|NCT00365352|Secondary|Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep adequacy domain ranged from 1 to 100, with a high score indicating greater adequacy. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Basline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269344|NCT00365352|Secondary|Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep disturbance domain ranged from 1 to 100, with a high score indicating greater impairment of sleep. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269345|NCT00365352|Secondary|Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the daytime somnolence domain ranged from 1 to 100, with a high score indicating greater daytime somnolence. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269346|NCT00365352|Secondary|Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF|The Profile of Mood States (POMS) Brief Form contains 30 adjectives; each participant is asked to rate the degree to which each adjective describes themselves based on how they felt during the past week including the date on which the adjective was rated. The possible ratings range from “0” (Not all all) to “4” (Extremely). The Total Mood Disturbance Score (range of 0 to 120) is obtained by summing the values of six domains. Higher scores indicate a more negative mood disturbance. The POMS was completed at Baseline (Day 1), and at the end of Weeks 4, 8, and 12 (or Early Termination).|Baseline to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269347|NCT00365352|Secondary|Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF|The Mood Assessment is a non-disease-specific question surveying global change in a participant's overall mood. Participants were asked to rate their overall change in mood since the start of the study by choosing a score in a range from 1 (Very Much Improved) to 7 (Very Much Worse). The assessment was completed at Day 1 and the ends of Weeks 4, 8, and 12 or (Early Termination).|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
1269348|NCT00365352|Secondary|Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF|"The Post-Sleep Questionnaire (PSQ) was designed to evaluate overall sleep quality, ability to function, and RLS symptoms' interference with sleep over the past week. Participants were asked to rate overall sleep quality (as either Excellent, Reasonable, or Poor), ability to function, number of nights with RLS symptoms, number of nights awakened by RLS symptoms, and the number of hours spent awake due to RLS symptoms over the past week."|End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
1269369|NCT00365261|Primary|Patient Self-report Data on Fatigue|Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue–Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).|2 days post treatment||||scores on a scale||Standard Error|Mean
1269370|NCT00365261|Primary|Pain|Pain was assessed with a 10-cm visual analog scale (0 = “no pain at all”; 10 = “severe, uncontrolled pain”).|post dosing||||scores on a scale||Standard Error|Mean
1269349|NCT00365352|Secondary|Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)|The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant’s overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as “Responders.”|Week 1 and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
1269350|NCT00365352|Secondary|Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF|The Average Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269351|NCT00365352|Secondary|Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF|"The Mean Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits A Responder is a participant with a score of much improved or very much improved on the investigator rated CGI I Scale at the end of treatment (Week 12 using LOCF)."|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
1269352|NCT00365352|Secondary|Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF|The Daily RLS pain score was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined study visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.|Baseline and End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269353|NCT00365352|Secondary|Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF|Average daily wake time after sleep onset was derived from the Pittsburgh Sleep Diary (PghSD) as the mean of non-missing total hours awake during the night after falling asleep over the 7 days before each visit. The change was calculated as the end of treatment (Week 12) value minus the Baseline value.|Baseline to End of Treatment (Week 12)|MITT Popultion. The number of participants assessed varies due to incomplete/missing data.|||minutes||Standard Deviation|Mean
1269354|NCT00365352|Secondary|Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF|Average daily total sleep time was derived from the Pittsburgh Sleep Diary (PghSD; an instrument with separate components to be completed [self-reported] at bedtime and waketime) as the mean of non-missing total sleep time over the 7 days before each visit, where total sleep time = [(wake up time – lights out time) – time to fall asleep – time awake during the night] in hours. The change was calculated as the end of treatment (Week 12) value minus the Baseline value.|Baseline to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||hours||Standard Deviation|Mean
1269355|NCT00365352|Secondary|Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||responders|||Number
1269356|NCT00365352|Secondary|Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Basline and Week 12|Participants included in the MITT Population with a known RLS treatment history|||participants|||Number
1269357|NCT00365352|Secondary|Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline and the End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269358|NCT00365352|Secondary|Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269359|NCT00365352|Secondary|Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269360|NCT00365352|Secondary|The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I|The Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved. The median time to onset is estimated using the product-limit estimation method.|Baseline (Day 1) to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||weeks||95% Confidence Interval|Median
1269361|NCT00365352|Secondary|Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of “much improved” or “very much improved.”|End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
1269362|NCT00365352|Secondary|Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
1269363|NCT00365352|Secondary|Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1269364|NCT00365352|Primary|"Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF"|"The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being “very much improved,” a score of 2 being much improved, a score of 3 being minimally improved, a score of 4 being no change, a score of 5 being minimally improved,a score of 6 being much worse, and a score of 7 being “very much worse. Participants with a response of much improved or very much improved were classified as responders."|Week 12|MITT Population|||participants|||Number
1269365|NCT00365352|Primary|Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)|The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline and Week 12|Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who also satisfied all of the following conditions: (1) completed the IRLS Rating Scale at Baseline; and (2) completed at least one on-treatment IRLS Rating Scale score during the treatment period|||scores on a scale||Standard Deviation|Mean
1269366|NCT00365300|Primary|Number of Patients Withdrawn From Study Due to Lack of Efficacy.|Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician’s judgment.|4 weeks double-blind|The analysis population was the Modified Intent to Treat, which included all GERD patients who completed the 4 week open-label treatment phase, were randomized into the 4 week double-blind phase, and took at least one dose of double-blind treatment.|||patients|||Number
1269367|NCT00365274|Primary|Objective Response Rate (ORR)|Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Up to 5 years||||percentage of participants|||Number
1269368|NCT00365261|Secondary|Opiate Dosing From Patient Controlled Analgesia|Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.|2 days post dosing||||mg||Inter-Quartile Range|Median
1269372|NCT00365209|Secondary|Post-treatment Curcumin Conjugates Plasma Concentrations|Post-treatment curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|At 30 day|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.|||µg/mL|Participants|Standard Deviation|Mean
1269373|NCT00365209|Secondary|Baseline Curcumin Conjugates Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|Baseline|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.|||µg/mL|Participants|Standard Deviation|Mean
1269374|NCT00365209|Secondary|Post-treatment Curcumin Conjugates Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|At 30 day|The analysis is based on 39 participants (21 participants from 2g curcumin group and 18 participatns from 4g curcumin group). In 2g group, a total of 13 samples with detectable levels were analyzed. In 4g group, a total of 12 samples with detectable levels were analyzed.|||µg/g protein|Participants|Standard Deviation|Mean
1269375|NCT00365209|Secondary|Baseline Curcumin Conjugates Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|Baseline|Samples from 21 participants in the 2g curcumin arm and 19 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin conjugates in rectal mucosa were found in 0 participants in the 2g arm and 1 participant on the 4g arm. Therefore, 0 samples from the 2g arm and 1 sample from the 4g arm are reported here.|||µg/g protein|Participants|Standard Deviation|Mean
1269376|NCT00365209|Secondary|Post-treatment Curcumin Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|At 30 day|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 2 participants in the 4g arm; therefore, 2 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.|||µg/mL|Participants|Standard Deviation|Mean
1269377|NCT00365209|Secondary|Baseline Curcumin Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|Baseline|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 4 participants in the 4g arm; therefore, 4 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.|||µg/mL|Participants|Standard Deviation|Mean
1269378|NCT00365209|Secondary|Post-treatment Curcumin Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|At 30 day|The analysis is based on 39 participants (21 participants from 2g curcmin, and 18 participants from 4 g curcumin). In 2g group, a total of 5 samples with detectable levels were analyzed. In 4g group, a total of 3 samples with detectable levels were analyzed.|||µg/g protein|Participants|Standard Deviation|Mean
1269379|NCT00365209|Secondary|Baseline Curcumin Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|Baseline|Samples from 21 participants in the 2g curcumin arm and 18 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin in rectal mucosa were found in 1 participant in the 2g arm and none in participants on the 4g arm. Therefore, only 1 sample from the 2g arm and 0 samples from the 4g arm are reported here.|||µg/g protein|Participants|Standard Deviation|Mean
1269380|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)|||percentage of labeled cells||Standard Deviation|Mean
1269381|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)|||percentage of labeled cells||Standard Deviation|Mean
1269383|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin : (N = 17 participants).|||percentage of labeled cells||Standard Deviation|Mean
1269384|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g crucumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)|||percentage of labeled cells||Standard Deviation|Mean
1269385|NCT00365209|Primary|Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)|Post-treatment prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
1269386|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)|||percentage of labeled cells||Standard Deviation|Mean
1269387|NCT00365209|Secondary|Changes in Total Aberrant Crypt Foci (ACF) Number|Changes in total aberrant crypt foci (ACF) number = Number of ACF at pre-treatment - Number of ACF at post-treatment|Baseline to 30 days|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)|||Number of ACF||Full Range|Median
1269388|NCT00365209|Secondary|Change in Cyclooxygenases (COX-1, COX-2), and Lipoxygenase (5-LOX) Protein Abundance|The protein levels for each enzyme will be expressed as an absolute change from baseline and graphed against % change of its enzyme product in the same individual. The degree of correlation between these parameters will be assessed by either Pearson’s correlation coefficient or Spearman’s rank order correlation coefficient.|Baseline to 30 days|There is not enough tissue for the analysis, so no data is provided.||||||
1269389|NCT00365209|Secondary|Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa|Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
1269390|NCT00365209|Secondary|Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa|Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
1269391|NCT00365209|Secondary|Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa|Post-treatment prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
1269392|NCT00365209|Secondary|Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa|Baseline prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
1269393|NCT00365209|Secondary|Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)|Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue|At 30 Day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
1269394|NCT00365209|Secondary|Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)|Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
1269395|NCT00365209|Primary|Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)|Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants) and Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
1269396|NCT00365144|Secondary|Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker||21 weeks|Only patients with an elevated baseline CA19-9 (>2x ULN) were included in this analysis (n = 26).|||Participants|||Count of Participants
1269397|NCT00365144|Secondary|Time to Tumor Progression|Time to tumor progression (TTP) was defined as the time from initial therapy to the first objective documentation of tumor progression (for patients with measurable disease) or to the data of death, if death was ascribed to progression of disease.|from initial therapy to the first objective documentation of tumor progression||||Days||95% Confidence Interval|Median
1269398|NCT00365144|Secondary|Objective Response as Measured by RECIST Criteria|Participants experiencing objecting response, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|21 weeks||||participants|||Number
1269399|NCT00365144|Primary|Safety and Toxicity|Treatment associated toxicities. Adverse event assessments were performed on day 1 of each treatment cycle and at the end of treatment; the longest duration of treatment was 7 cycles (x 3 weeks)|21 weeks||||participants|||Number
1269400|NCT00365144|Primary|Overall Survival Rate at 6 Months|Number of participants alive at 6 months|6 months|All participants were followed for survival|||participants|||Number
1269401|NCT00365105|Secondary|Utility and Cost Effectiveness of the Use of Radiopharmaceuticals and Bisphosphonates as Measured by the EuroQol-5 Dimension (EQ-5D)||From pre-treatment to 1 year|||||||
1269402|NCT00365105|Secondary|Changes in Pain Control as Measured by Brief Pain Inventory (BPI)||From pre-treatment to 1 year|||||||
1269403|NCT00365105|Secondary|Changes in Quality of Life as Measured by FACT-G||From pre-treatment to 1 year|||||||
1269406|NCT00365105|Primary|Time to Development of a Malignant Skeletal-related Events (SRE)|Median Time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.|From randomization to date of SRE development|All eligible patients who started study treatment.|||months||95% Confidence Interval|Median
1269407|NCT00365053|Secondary|Histone Acetylation by IHC and Western Blotting|Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.|At baseline and at 4 hours after last dose of PXD101 on day 5|IHC data were not collected.||||||
1269408|NCT00365053|Secondary|Apoptosis by TUNEL Assay|Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.|At baseline|Assay data were not collected.||||||
1269409|NCT00365053|Secondary|Toxicity Profile|Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 3 years||||Participants|||Count of Participants
1269410|NCT00365053|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 3 years||||Months||95% Confidence Interval|Mean
1269411|NCT00365053|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 3 years||||Months||95% Confidence Interval|Median
1269412|NCT00365053|Primary|Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 3 years||||percentage of participants|||Number
1269413|NCT00364949|Primary|Infant Birth Weight (Male and Female)||birth|Birth weight of the male and female infants.|||gram||Standard Deviation|Mean
1269414|NCT00364949|Primary|Dehydroepiandrosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||ng/ml||Standard Deviation|Mean
1269415|NCT00364949|Primary|Dihydrotestosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||pg/ml||Standard Deviation|Mean
1269416|NCT00364949|Primary|17-hydroxyprogesterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||ng/dl||Standard Deviation|Mean
1269417|NCT00364949|Primary|Testosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||ng/dl||Standard Deviation|Mean
1269418|NCT00364949|Primary|Androstenedione Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||ng/dl||Standard Deviation|Mean
1269419|NCT00364949|Primary|Estradiol Level in Female Offspring|The blood that were analyzed were taken from cord blood and not from the offspring.|One time sampling from the cord blood|The number of the participants analyzed only included the levels for the female offspring.|||pg/ml||Standard Deviation|Mean
1269420|NCT00364923|Secondary|Overall Survival Per Independent Central Review|Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.|Assessed every 14 weeks while on treatment, and after disease progression no less frequently than every 6 months for up to 2 years after first dose.|Analysis was per protocol, based on the number of patients (pts) who had an event (death or censoring) at the time of data cut-off.|||Months||Full Range|Median
1269421|NCT00364923|Secondary|Progression-free Survival Per Independent Central Review|Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status & survival. Pts who did not have response assessments after baseline were censored at treatment day 1.|Calculated as the number of days from treatment day 1 to the date of disease progression or death, regardless of cause for up to 2 years after initial dose|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored. Pts were censored for lack of PD, receipt of other anti-cancer therapy before PD, termination of study/follow-up for response, and transplant.|||Days||Full Range|Median
1269422|NCT00364923|Secondary|Duration of Response Per Independent Central Review|Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence & reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.|Measured from the first day of documented response, assessed at prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose|Analysis was per protocol. Based on the number of responding pts (n=32) in the evaluable population (n=109), as assessed by independent central review protocol.|||Days||Full Range|Median
1269423|NCT00364923|Primary|Response Rate Per Independent Central Review|Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.|Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose|Analysis was per protocol and was based on number of patients (pts) who responded in the evaluable population. The evaluable population consisted of all pts who received at least one dose of pralatrexate and had an eligible peripheral T-cell lymphoma (PTCL) histopathological subtype confirmed by central pathology review.|||of Patients who Responded|||Number
1269424|NCT00364858|Secondary|Mean Change From Baseline in Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation|The mean composite scores (0 being worst and 100 being best) for both treatment groups approximated those of the general population at baseline. Composite score - The overall composite scores were comprised of a standardized physical and mental component score.|Baseline and Month 24 (or at time of discontinuation)|Quality of life was evaluated and measured by the SF-36 questionnaire.|||Units on a scale||Standard Deviation|Mean
1269425|NCT00364858|Secondary|Mean Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation.|The mean composite scores (0 being worst and 100 being best) for both treatment groups at Month 24/Discontinuation. The mean composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.|Month 24 (or at time of discontinuation)|Quality of life was evaluated and measured by the SF-36 questionnaire.|||Units on a scale||Standard Deviation|Mean
1269426|NCT00364858|Secondary|Mean Composite Scores of the SF-36 Health Survey at Baseline|The mean composite scores (0 being worst and 100 being best) for both treatment groups at Baseline. Composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.|Baseline|Quality of life was evaluated and measured by the SF-36 questionnaire.|||Units on a scale||Standard Deviation|Mean
1269427|NCT00364858|Primary|Number of Participants With Clinical Success at Month 24/Discontinuation|Patients are considered to be a clinical success if ALL of the following are met: The patient’s hemoglobin does not fall more than 1.25g/dL for women or 1.5 g/dL for men below the patient’s baseline value, platelet count does not fall more than 25% below the patient’s baseline value or does not fall below 80,000 mm3, liver and spleen volumes are not greater than 20% above the patient’s baseline value, no evidence of bone disease progression, including no incidence of pathologic fractures, medullary infarctions, lytic lesions or avascular necrosis and has had no bone crises during the study.|Month 24 (or at time of discontinuation)|Intent-to-Treat (ITT) Population. All patients who enrolled in the study and received AT LEAST ONE infusion were included in the ITT population.|||patients|||Number
1269428|NCT00364845|Secondary|Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.|Week 24|Subset of Full Analysis Set, composed of all randomized participants with available data|||Units on a scale||95% Confidence Interval|Mean
1269429|NCT00364845|Secondary|Mean Hemoglobin During the Evaluation Period||Evaluation Period (Weeks 22-36)|Subset of Full Analysis Set, composed of all randomized participants with available data|||g/L||95% Confidence Interval|Mean
1269430|NCT00364845|Secondary|Number of Participants With Hemoglobin (Hb) ≥ 110 g/L|Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.|Evaluation Period (Weeks 22-36)|Subset of Full Analysis Set, composed of all randomized participants with available data|||Participants|||Number
1269431|NCT00364845|Primary|Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).|Week 24|Subset of Full Analysis Set, composed of all randomized participants with available data.|||Units on a scale||Standard Error|Mean
1269432|NCT00364832|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Participants|||Number
1269433|NCT00364832|Secondary|Number of Participants With Marked Laboratory Abnormalities|Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L).|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Participants|||Number
1269434|NCT00364832|Secondary|Mean Change in Pulse Rate|Mean change in pulse rate was reported.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug. Participants with available data at the time of evaluation were analyzed.|||Beats per minute||Standard Deviation|Mean
1269435|NCT00364832|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis|Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) value is the measurements taken at screening assessment and run-in period (Weeks –2 and –1).|From Baseline (Day -28 to Day 1) to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Millimeters of Mercury||Standard Deviation|Mean
1269436|NCT00364832|Secondary|Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)|The ITT population was considered for analysis which included all randomized participants.|||Percentage of Hct||Inter-Quartile Range|Median
1269437|NCT00364832|Primary|Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and –1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)|The ITT population was considered for analysis which included all randomized participants.|||gram per deciliter||Inter-Quartile Range|Median
1269438|NCT00364819|Secondary|Change in Serum Alkaline Phosphatase|The difference in serum alkaline phosphatase from Baseline to Week 52|52 Weeks||||U/L||Standard Deviation|Mean
1269439|NCT00364819|Secondary|Change in Serum Immunoglobulin M|The difference in serum immunoglobulin M from Baseline to Week 52|52 Weeks||||mg/dL||Standard Deviation|Mean
1269440|NCT00364819|Secondary|Change in Serum Immunoglobulin A|The difference in serum immunoglobulin A from Baseline to Week 52|52 Weeks|1 subject with missing data.|||mg/dL||Standard Deviation|Mean
1269441|NCT00364819|Secondary|Change in Serum Immunoglobulin G|The difference in serum immunoglobulin G from Baseline to Week 52|52 Weeks||||mg/dL||Standard Deviation|Mean
1269442|NCT00364819|Primary|Number of Participants With Adverse Events||52 weeks||||Participants|||Count of Participants
1269443|NCT00364793|Secondary|Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.|||percentage of CD4 cells||Inter-Quartile Range|Median
1269444|NCT00364793|Secondary|CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.|||cells/mm^3||Inter-Quartile Range|Median
1269445|NCT00364793|Secondary|Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants|HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline through Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.|||log10 c/mL||Inter-Quartile Range|Median
1269446|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants|Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 50 c/mL; denominator was all who remained on treatment through the specific week.|Weeks 60, 72, 84, and 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.|||participants|||Number
1269979|NCT00360334|Secondary|Percent of Patients Achieving HbA1c < 6.5%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.|||Percentage of participants|||Number
1269447|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants|Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 400 c/mL; denominator was all who remained on treatment through the specific week.|Weeks 60, 72, 84, and 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.|||participants|||Number
1269448|NCT00364793|Secondary|Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||h||Standard Deviation|Mean
1269449|NCT00364793|Secondary|CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
1269450|NCT00364793|Secondary|CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1269451|NCT00364793|Secondary|AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms*time per milliliter (ng•h/mL).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
1269452|NCT00364793|Secondary|Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were <LLOQ in all age groups except >=6 months to < 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were <LLOQ; LLOQ/2 was imputed for those samples for summary statistics. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1269453|NCT00364793|Secondary|Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population|PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC<110 μM*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: > 3.3* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3).|Baseline to Week 48|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles at Week 2 were analyzed. n=number of participants with AUC<110 µM•h and number of participants with AUC>=110 µM•h.|||participants|||Number
1269503|NCT00364130|Primary|Change in Spine Volumetric BMD Z-score at 12 Months|We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.|||Z-score||Standard Deviation|Mean
1271041|NCT00352053|Secondary|Change From Baseline to Week 336 in HIV-1 RNA|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method||||||
1269454|NCT00364793|Secondary|Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound|At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: > 3.1* the 50% inhibitory concentration (IC50) of the control strain; EFV: > 3.3* IC50 ; ddI: > 2.6*IC50. Virologic failure: <1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA > 10,000 c/mL with prior value < 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance.|Baseline to Week 48|Participants who met the definition of virologic failure per protocol (PP): n=6 ; in addition, those who rebounded on treatment with plasma HIV RNA > 10,000 c/mL but samples were not obtained within specified 35 day limit were included (not PP): n=5; participants with virologic failure and with samples available for analysis of virus changes:n=11.|||participants|||Number
1269455|NCT00364793|Secondary|Number of Participants With Hematologic Abnormalities - Treated Participants|Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: <6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999*10^9/L; Gr 2: 50.000-99.999*10^9/L; Gr 3: 25.000-49.999*10^9/L; Gr 4: <25.000*10^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500*10^9/L; Gr 2: 1.500-1.999*10^9/L; Gr 3: 1.000-1.499*10^9/L; Gr 4: <1.000*10^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1).|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).|||participants|||Number
1269456|NCT00364793|Secondary|Number of Participants With Serum Chemistry Abnormalities - Treated Participants|Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - < LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: <8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: >13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: <6.1 mg/dL; creatinine Gr1: 1.1-1.3*ULN; Gr 2: 1.4-1.8*ULN; Gr 3: 1.9-3.4*ULN; Gr 4: >=3.5*ULN; lipase Gr 1: 1.1-1.5*ULN; Gr 2: 1.6-3.0*ULN; Gr 3: 3.1-5.0*ULN; Gr 4: >5.0*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: >7.0 (<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: >=160 (<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: >15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication.|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).|||participants|||Number
1269457|NCT00364793|Secondary|Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants|Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 >300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 >=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: >1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: >500 (> 500) mg/dL. Glucose, serum, low, >=1 month of age (<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: <30 (<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken.|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).|||participants|||Number
1269458|NCT00364793|Secondary|Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population|Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. AST Gr 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. Total bilirubin Gr 1: 1.25 to 1.5*ULN; Gr 2: 1.6 to 2.5*ULN; Gr 3: 2.6 to 5.0*ULN; Gr 4: >5.0*ULN. ALP (U/L) Gr 1: 1.25 to 2.5*ULN, Gr 2: 2.6 to 5.0*ULN, Gr 3: 5.1 to 10.0*ULN, Gr 4: >10.0*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to <LLN ; Gr 2: 2.0-2.9 g/dL; Gr 3: < 2 g/dL. Gr 4: Not applicable. Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).|||participants|||Number
1269466|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 24.|Week 24|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.|||participants|||Number
1269459|NCT00364793|Secondary|Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events|Center for Disease Control and Prevention (CDC) classification of Class C events used to define acquired immunodeficiency syndrome (AIDS): include pneumocystis pneumonia, pneumonia, pulmonary tuberculosis. AE=new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. AE Severity: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling (Division of AIDs Table, published December 2004). Baseline=within 50 days post screening, prior to start of study drug. 2 categories for death presented (on-treatment and enrolled/not treated).|Baseline to Week 96|All categories except one analyzed treated participants, who received at least 1 dose of study drug (EFV). One category analyzed enrolled participants who were not treated and cannot be assigned to a group.|||participants|||Number
1269460|NCT00364793|Primary|Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
1269461|NCT00364793|Primary|Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1269462|NCT00364793|Primary|Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars*time (µM•h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||µM•h||Geometric Coefficient of Variation|Geometric Mean
1269463|NCT00364793|Secondary|Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 24 and 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.|||percentage of CD4 cells||Inter-Quartile Range|Median
1269464|NCT00364793|Secondary|CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 24 and 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.|||cells/mm^3||Inter-Quartile Range|Median
1269465|NCT00364793|Secondary|Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants|HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline through Week 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.|||log10 c/mL||Inter-Quartile Range|Median
1269498|NCT00364130|Secondary|Change in QCT Tibia Trabecular Volumetric BMD at 12 Months|We calculated the mean change in tibia trabecular volumetric BMDbetween baseline and 12 months as measured by (QCT)|12 months||||cm^3||Standard Deviation|Mean
1269467|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 24.|Week 24|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.|||participants|||Number
1269468|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants.|Week 48|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.|||participants|||Number
1269469|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants.|Week 48|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.|||participants|||Number
1269470|NCT00364793|Primary|Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1269471|NCT00364611|Secondary|Number of Participants With Adverse Events (AE)|"An adverse event (AE) was any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the clinical study. AEs occurring on or after first dose of study medication inclusive to 30 days post-last dose were the treatment emergent adverse events (TEAEs).~An serious adverse event was an AE that at any dose (including overdose) resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly, and/or was medically important."|From treatment initiation to 30 days after the last dose of study treatment|Safety population: all participants who received at least one dose of study medication|||participants|||Number
1269472|NCT00364611|Secondary|Overall Survival (OS) Time|"OS was the interval between the date of study entry and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.~OS time was estimated from Kaplan-Meier Plots."|From treatment initiation to June 2011|Intent-to-treat population: all registered participants.|||days|Participants|Inter-Quartile Range|Median
1269473|NCT00364611|Secondary|Duration of Response (DR)|"DR was the interval from date of initial documented confirmed response (CR or PR) to the first documented confirmed date of disease progression (PD) or death from any cause in the absence of previous documentation of objective tumor progression.~Participants who were alive and without any record of PD at the time of discontinuation were censored at the last available tumor assessment date; participants with non-study anti-cancer therapy during the study were censored at the last available tumor assessment date prior to the anti-cancer therapy.~DR was estimated from Kaplan-Meier Plots."|From treatment initiation to June 2011|Participants with a documented response of CR or PR.|||days|Participants|95% Confidence Interval|Median
1269474|NCT00364611|Secondary|Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria|"Clinical Benefit (CB) was achieved in participants with a response (CR + PR) or a stable disease (SD).~According to RECIST~CR was the disappearance of all tumor lesions~PR was a pre-defined decrease in the size of tumor lesions~SD was neither sufficient decrease in tumor size to qualify for PR or sufficient increase to qualify for PD.~Confirmation of a response needed 2 responses scored, separated by 28 days or more (for CR and PR), and by 26 weeks or more (for SD)."|From treatment initiation to June 2011|Intent-to-treat: all registered participants.|||participants|||Number
1269475|NCT00364611|Secondary|Confirmed Overall Response (OR) Based on RECIST Criteria|"Confirmed OR was confirmed Complete Response (CR) + confirmed Partial Response (PR). According to RECIST~CR was the disappearance of all tumor lesions~PR was a pre-defined decrease in the size of tumor lesions.~To determine a response, radiologic tumors assessments were performed using computed tomography (CT) and/or magnetic resonance imaging (MRI) of the chest, and the abdomen, bone scan or positron emission tomography (PET) scan, and other imaging techniques as clinically indicated. To confirm a response, 2 assessments separated by 28 days or more were required."|From treatment initiation to June 2011|Intent-to-treat population: all registered participants.|||participants|||Number
1269476|NCT00364611|Primary|Time to Progression-free Survival (PFS)|"Time to PFS was the interval from the date of registration to the earliest of the following documented dates:~PD as defined by RECIST (criteria pre-defining changes in lesion size or appearance)~symptomatic deterioration~death.~Time to PFS was estimated from Kaplan-Meier Plots."|From treatment initiation to PFS event (up to June 2011)|Intent-to-treat population: all registered participants|||days|Participants|95% Confidence Interval|Median
1269477|NCT00364611|Primary|Progression-free Survival (PFS) Rate: Percentage of Participants With PFS|"PFS was the time from registration to first documentation of~progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance~symptomatic deterioration~death due to any cause (in absence of PD).~The Percentage of participants with PFS is reported.~For the analysis, participants were censored~on the last available tumor assessment date on study treatment if they~had no PFS event~were on anticancer therapy not related to study treatment~on the registration date if they~did not receive study drug~had no post baseline tumor assessment"|Up to 6 months and 12 months after treatment initiation|Intent to treat population: all registered participants|||percentage of participants||95% Confidence Interval|Number
1269478|NCT00364533|Secondary|The SPID at 12, 24, and 72 Hours Relative to First Dose.|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.|3 days|Due to termination of trial, results were not analyzed.||||||
1269479|NCT00364533|Secondary|Time to First Rescue Pain Medication.||3 days|Due to termination of trial, results were not analyzed.||||||
1269480|NCT00364533|Primary|Sum of Pain Intensity Difference Over 48 Hours (SPID48)|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.|48 hours|Because the Sponsor terminated the study, the planned sample size was not reached in any treatment group, therefore, only a brief summary of an exploratory analysis of the primary efficacy variable (SPID48) is presented.|||score on a scale||Standard Deviation|Mean
1269481|NCT00364377|Primary|Lowering of Fasting Glucose|fasting glucose taken as the mean of blood glucose measured at -30, -20, -10 and 0 minutes prior to each inpatient meal study|8 weeks|Analysis was per protocol - all participants completed the intervention|||mmol/l||Standard Error|Mean
1269482|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough|"Cough was assessed using Question 1 (How much did you cough) of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit||||Weeks||Inter-Quartile Range|Median
1269483|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea|"Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 (Were you short of breath) and Question 3 of the QLQ-C30 (Were you short of breath when you rested), Questions 4 (Were you short of breath when you walked) and 5 (Were you short of breath when you climbed stairs) of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit||||Weeks||Inter-Quartile Range|Median
1269484|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain|"Pain was assessed as the average score of two items: Question 9 (Have you had pain) and 19 (Did pain interfere with your daily activities) of the QLQ-C30.~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit||||Weeks||Inter-Quartile Range|Median
1269499|NCT00364130|Secondary|Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months|We calculated the mean change in whole body bone mineral content Z-score, as measured by DXA, between baseline and 12 months|12 months||||Z-score||Standard Deviation|Mean
1269500|NCT00364130|Secondary|Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months|We calculated the mean change in femoral neck areal bmd Z-score between baseline and 12 months as measured by DXA|12 months||||Z-score||Standard Deviation|Mean
1269501|NCT00364130|Secondary|Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months|We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months|12months||||Z-score||Standard Deviation|Mean
1269485|NCT00364351|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.|RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression||||Participants|||Number
1269486|NCT00364351|Secondary|Objective Response Rate (ORR)|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.|RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months||||Participants|||Number
1269487|NCT00364351|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||Months||Full Range|Median
1269488|NCT00364351|Primary|Progression-Free Survival (PFS)|"Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.~Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions."|progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.||||Weeks||Full Range|Median
1269489|NCT00364286|Primary|Participants With Objective Response|Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: > 50% decrease; Liver/Spleen CR: Not palpable; PR: > 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: >1,500/μl, PR: > 1,500/μl or >50% improvement from baseline; Platelets for CR: >100,000/μl, PR: >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused) for CR: >11,0 g/dl; PR: >11.0 g/dl or >50% improvement from baseline; Lymphocytes for CR: <4,000/μl and PR: >50% decrease; Bone Marrow aspirate for CR: <30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: < 30% lymphocytes with residual disease on biopsy for nodular PR.|up to 3 months|Three participants were not evaluable for response due to early discontinuation of treatment (0-3 days).|||Participants|||Number
1269490|NCT00364182|Secondary|36-Item Short-Form Health Survey (SF-36): Physical Functioning Domain|SF-36: standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The physical functioning domain score was an average of the individual physical functioning question scores across all time points, which was scaled 0-100 (100=highest level of functioning).|Weeks 16, 32, and 56|ITT; N=number of participants with evaluable data.|||units on a scale||Standard Deviation|Mean
1269491|NCT00364182|Secondary|HRPQ Score: Hours Lost From Work or School at 48 Hours Post-bleed|HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.|48 hours post-bleed|ITT|||hours||Standard Deviation|Mean
1269492|NCT00364182|Secondary|Health-Related Productivity Questionnaire (HRPQ) Score: Hours Lost From Work or School at 24 Hours Post-bleed|HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.|24 hours post-bleed|ITT|||hours||Standard Deviation|Mean
1269493|NCT00364182|Secondary|Acute Pain After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night and included a Brief Pain Inventory (BPI): self-reported scale that measured severity of pain experienced over the past 24 hours. Questions included How much pain right now? 0 (no pain) to 10 (pain as severe as you can imagine).|24 and 48 hours post-bleed|ITT|||units on a scale||Standard Deviation|Mean
1269494|NCT00364182|Secondary|Quality of Sleep Measured by Sleep Diary After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How would you describe the quality of your sleep last night? 1=Very Good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor. Reported as quality of sleep during study.|24 and 48 hours post-bleed|ITT|||Units on a scale||Standard Deviation|Mean
1269495|NCT00364182|Secondary|Amount of Sleep Measured by Sleep Diary After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How long do you think you slept last night? Reported as average duration of sleep during study.|24 and 48 hours post-bleed|ITT|||hours||Standard Deviation|Mean
1269496|NCT00364182|Primary|Annualized Number of Bleeding Episodes|Annualized bleed rate (ABR) or number of bleeds per year derived for each participant for each treatment regimen by using the following formula: ABR = number of bleeds / (days on treatment regimen / 365.25)|Baseline up to Week 56|Intention-to-treat (ITT) population: all enrolled participants|||episodes||95% Confidence Interval|Least Squares Mean
1269497|NCT00364156|Primary|Biochemically Verified 7-day Point Prevalence Abstinence|To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.|End of Treatment (week 24)|Intention to Treat analysis (ITT)|||Participants|||Number
1269504|NCT00364130|Primary|Change in Tibia Cortical Area Z-score 12 Months|We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months.|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.|||Z-score||Standard Deviation|Mean
1269505|NCT00364130|Primary|Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months|"We calculated the mean change in tibia trabecular volumetric BMD Z-score between baseline and 12 months, as measured by peripheral quantitative computed tomography (pQCT).~The Z-score, or Standard Deviation Score, is a measure of the number of standard deviations that an individual is above or below the median value in a healthy child or adolescent of the same age, sex and race. For example, a Z-score of 0 means that an individual's result is equivalent to the 50th percentile in a healthy population. A Z-score of -1.0 means that an individual's result is equovalent to the 16th percentile in a healthy population."|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.|||Z-score||Standard Deviation|Mean
1269506|NCT00364013|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: “Is there a reasonable possibility that the event may have been caused by the study treatment?"|From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.|Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX’, but received ‘FOLFOX Alone’ so is counted in that group.|||participants|||Number
1269507|NCT00364013|Secondary|Duration of Response|Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review.|Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Evaluable Central Tumor Response Analysis Set: Responders|||months||95% Confidence Interval|Median
1269508|NCT00364013|Secondary|Time to Progression|Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria.|From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
1269509|NCT00364013|Secondary|Percentage of Participants With an Objective Response|Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.|Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Evaluable Central Tumor Response Analysis Set (subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review).|||percentage of participants||95% Confidence Interval|Number
1269510|NCT00364013|Secondary|Overall Survival|The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date.|From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.|KRAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
1269511|NCT00364013|Primary|Progression-free Survival|Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.|From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.|KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)|||months||95% Confidence Interval|Median
1269512|NCT00363896|Primary|Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment|Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks|Week 12|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Liters||Standard Error|Least Squares Mean
1269513|NCT00363896|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment|Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Percentage of Patients|||Number
1269514|NCT00363896|Secondary|Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment|"Time to first moderate or severe exacerbation:~Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation."|Week 52|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Days||95% Confidence Interval|Median
1269515|NCT00363896|Primary|Trough FEV1 (L) at 28 Weeks on Treatment|Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks|Week 28|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Liters||Standard Error|Least Squares Mean
1269516|NCT00363883|Secondary|Progression-free Survial|Will be estimated using the product-limit method of Kaplan and Meier. Progression defined using RECIST v1.0 criteria, at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions.|assessed up to 26 weeks||||months||95% Confidence Interval|Median
1269517|NCT00363883|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|Up to 26 weeks||||months||95% Confidence Interval|Median
1269518|NCT00363883|Primary|Objective Tumor Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Response assessed after every 2 cycles (6 weeks) up to 26 weeks||||percentage of patients|||Number
1269519|NCT00363805|Primary|Change in Urinary 8-F2-isoprostanes Levels|the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels|Baseline and 6 months|The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identity of the analyte was confirmed in the sample.|||ng/mg creatinine||Standard Deviation|Mean
1269520|NCT00363805|Primary|Change in Urinary 8-hydroxydeoxyguanosine Levels|the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels|Baseline and 6 months|The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identify of the analyte was confirmed in the sample.|||ng/mg creatinine||Standard Deviation|Least Squares Mean
1269521|NCT00363779|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|3 months||||Participants|||Number
1269522|NCT00363779|Primary|Changes in Gene Expression Patterns|The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.|Baseline and 12 weeks|This outcome measure was not performed because there were insufficient data points to provide any statistical power.||||||
1269523|NCT00363766|Secondary|Number of Participants With Adverse Events (Safety)|Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.|First treatment dose up to 25.23 months|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1269524|NCT00363766|Secondary|Duration of Stable Disease|Duration of stable disease (SD) is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Time from documented stable disease or better to first date of progressive disease up to 10.35 months|All enrolled participants who received at least 1 dose of study drug and had a best overall response of stable disease or better.|||months||90% Confidence Interval|Median
1269525|NCT00363766|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Time of response to progressive disease or death up to 10.35 months|Since there were zero participants with CR or PR, the duration of response could not be analyzed.||||||
1269526|NCT00363766|Secondary|Overall Survival Time|Defined as the time from date of first dose to the date of death due to any cause.|First treatment dose to death due to any cause up to 25.23 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
1269527|NCT00363766|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY573636||Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle)|Participants who received study drug and had pharmacokinetic (PK) data at the specified time points.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1269528|NCT00363766|Secondary|Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)|Objective response rate is the percentage of participants with complete response (CR) + partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|First treatment dose to measured progressive disease or death due to any cause up to 10.35 months|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1269529|NCT00363766|Secondary|Progression-Free Survival|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|First treatment dose to measured progressive disease or death from any cause up to 10.35 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
1269530|NCT00363766|Primary|Time to Progression|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|First dose to measured progressive disease or death from study disease up to 10.35 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
1269531|NCT00363675|Primary|Moberg Pickup Test|The child picks up 12 small objects such as a coin, safety pin and paper clip one at a time and puts them in a container. The time in seconds to complete the task is the score.|Seconds to pick up all 12 objects|A convenience sample was planned for this study.|||Seconds||Full Range|Median
1269532|NCT00363675|Primary|Grip Strength|This is a measure of grip strength in pounds using a dynamometer. The subject squeezes the dynamometer as hard as possible for three trials separated by a short rest. The mean of the three trials is the score.|Baseline|Convenience sample was planned for this study.|||Pounds||Full Range|Median
1269533|NCT00363675|Primary|Range of Motion, Total Active Motion (TAM)|Subjects' degrees of hand motion are measured by a trained therapist and recorded. Total Active Motion is a measure of finger range of motion that can be used to predict functional movement of the hand. The TAM is the sum of the degrees of active motion of each of the three joints of the fingers, and two joints of the thumb. For this study we also included wrist motion. Full TAM is 1,455 degrees of motion.|Baseline|Convenience sample was planned for ths study.|||Degrees||Full Range|Median
1269534|NCT00363675|Primary|Blocks & Box (Standardized Test).|Children are asked to move as many blocks as possible from one box to another in one minute. The number of blocks moved is the score.|Baseline|Convenience sample was planned for this study.|||Blocks||Full Range|Median
1269535|NCT00363649|Secondary|Early Discontinuation|Number of participants unable to complete protocol-specified treatment due to toxicity.|1 year|This outcome includes all participants who were either started on an arm or crossed over to an arm.|||Participants|||Count of Participants
1269536|NCT00363649|Secondary|Disease-free Survival|Median number of days to progression of disease in participants who stopped all treatment as directed by the protocol.|Up to 8 years|Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.|||days||Full Range|Median
1269537|NCT00363649|Secondary|Time to Complete Molecular Remission|Number of months from randomization to molecular remission as defined by polymerase chain reaction negativity.|Up to 27 months|Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.|||months||95% Confidence Interval|Median
1269538|NCT00363649|Primary|Complete Remission Rate|Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity.|Up to 18 months|Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.|||percentage of participants|||Number
1269539|NCT00363649|Primary|Progression-free Survival|Number of patients alive and without disease progression or relapse|1 year after treatment has been stopped|Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.|||Participants|||Count of Participants
1269540|NCT00363545|Secondary|Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes|The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3.|From the first vaccine dose (Dose 1) up to Month 4|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.|||Subjects|||Number
1269541|NCT00363545|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (from Day 0 to Month 4)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
1269542|NCT00363545|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
1269543|NCT00363545|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were cough/runny nose, diarrhea, fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (≥) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (≥) 3 episodes of vomiting/day. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.|||Subjects|||Number
1269557|NCT00363480|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12|FEV1, an amount of air exhaled by a person during a forced breath in one second. FEV1 assessed at Visit 1 and at Visits 3, 4, 5, 6. Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.|Baseline (Visit 3) up to Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Litre/second (L/Sec)||Standard Deviation|Mean
1269544|NCT00363545|Secondary|Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies|Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of ≥ 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group.|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the ATP cohort for immunogenicity stool analysis subset, defined as the first 200 subjects for whom pre-vaccination stool samples were available and with available anti-rotavirus IgA antibody results at post sampling time point or with vaccine virus in stools collected after the first vaccine dose up to Month 4.|||Subjects|||Number
1269545|NCT00363545|Secondary|Concentrations of Anti-rotavirus IgA Antibodies|Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.|||U/mL||95% Confidence Interval|Geometric Mean
1269546|NCT00363545|Primary|Number of Seroconverted Subjects Against Human Rotavirus|A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.|||Subjects|||Number
1269547|NCT00363480|Secondary|Number of Participants With Occurrence of (Near-) Incidents Associated With Peak Flow Measurements|Frequencies of participants with at least one (near-) incident associated with peak flow measurements were recorded. analysis was done on safety population.|Up to Week 12|Safety Set.|||participants|||Number
1269548|NCT00363480|Secondary|Assessment of Tolerability by Change From Baseline of Pulse Rate|Pulse rate was recorded over time (Visit 1, 3, 4, 5, and 6). Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.|Baseline (Visit 3) up to Week 12|Safety Set. Only those participants available at the specified time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
1269549|NCT00363480|Secondary|Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were recorded over time (Visit 1, 3, 4, 5, and 6). Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.|Baseline (Visit 3) up to Week 12|Safety Set. Only those participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1269550|NCT00363480|Secondary|Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE|An AE is any untoward medical occurrence in a participant or clinical AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. Number of participants with at least one treatment emergent serious and, non-serious AE were reported.|Up to Week 12|Safety Set.|||Participants|||Number
1269551|NCT00363480|Secondary|Number of Participants With Adverse Events (AE) Leading to a Change in Asthma Treatment|AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. Number of participants with AE who lead to change in asthma treatment were reported.|Up to Week 12|Safety Set.|||Participants|||Number
1269552|NCT00363480|Secondary|Number of Participants With Emergency Visits Due to Asthma|Frequencies of emergency visits per participant were recorded during treatment period. Only the participants at risk were considered when calculating the incidence rates.|Up to week 12|Safety set comprised of participants who received study medication at least once s participants who did not administer any study medication (those who returned all study medication dispensed) were not included in the Safety Set. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1269553|NCT00363480|Secondary|Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12|Number of nights with no night time awakening were recorded at Week 12. Baseline was the last corresponding time period immediately prior to Visit 3.|Baseline (Visit 3) and week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Percent Change||Standard Deviation|Mean
1269554|NCT00363480|Secondary|Change From Baseline in Number of Additional Usage of Salbutamol at Week 12|Salbutamol was given as a rescue medicine, used on <= 2 days and at most 4 occasions per week. Change from baseline value was calculated by subtracting the baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Visit 3) and week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Number of occassions||Standard Deviation|Mean
1269555|NCT00363480|Secondary|Change From Baseline in Mean 24-hour Symptom Score at Week 12|The various symptoms like wheezing, shortness of breath, coughing and chest tightness were assessed by the participants every morning using a symptom score scale which ranged from 0 (no symptoms during the past 24 hours) to 5 (symptoms so severe that participant could not go to work or carry out other normal daily activities). Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Visit 3) and Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Score on Scale||Standard Deviation|Mean
1269556|NCT00363480|Secondary|Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12|PEF, a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air. The mean morning PEF evaluated by means of the data documented in the asthma diaries. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Visit 3) and Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Percentage||Standard Deviation|Mean
1269558|NCT00363480|Secondary|Correlation of Change in AQLQ Score and Change in ACT Score|Correlation between change in the AQLQ and ACT score was tabulated using the Pearson coefficient of correlation (linear correlation). The AQLQ contained 32 items in 4 domains: activity limitation, symptoms, emotional function and environmental stimuli. Scores for the domains as well as the overall score were scaled within a range of 1 (worst) to 7 (best).|Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||participants|||Number
1269559|NCT00363480|Secondary|Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ)|For the level of asthma control, baseline values were derived taking the last 8 weeks during the pre-treatment period prior to Visit 3 into consideration. Regarding derived variables based on the asthma diary, data from the last week prior to Visit 3 was taken. Visit 3, regarded as baseline. AQLQ has 32 questions regarding activities, emotions, symptoms, and environmental triggers. Each item values range from 1 (maximum impairment) to 7 (no impairment). A positive change from baseline score indicates improvement.|Baseline (Visit 3) up to Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Score on Scale||Standard Deviation|Mean
1269560|NCT00363480|Secondary|Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12|Well controlled or totally controlled asthma assessments were done according to the GOAL criteria. A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score >1(Range: 0= None to 5= severe), rescue salbutamol use on <= 2 days and at most 4 occasions per week, and morning peak flow >= 80% of the predicted value on each day per week. All of the criteria which included no night-time awakenings due to asthma (diary entry),no emergency visits (diary entry), no exacerbations and no treatment-related adverse events leading to treatment change were fulfilled. The total ACT score was based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1269561|NCT00363480|Secondary|Change From Baseline in Mean ACT Score at Visit 6|The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. In order to derive the total ACT score, all 5 questions had to be answered. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Viait 3) and Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1269562|NCT00363480|Secondary|Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12|The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control. In order to derive the total ACT score, all 5 questions needed to be answered. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Visit 3) and Week 12|Full Analysis Set comprised of all participants with at least one post-baseline (Visit 3) efficacy measurement during clinic visits (Visit 4, 5, 6) or valid diary data documented for at least one week post-baseline was included. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
1269563|NCT00363480|Primary|Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12|A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score >1 (Range: 0= None to 5= severe), rescue salbutamol use on <= 2 days and at most 4 occasions per week, and a morning peak flow >= 80% of the predicted value on each day per week. All of the criteria which includes no night-time awakenings due to asthma (diary entry), no emergency visits (diary entry), no exacerbations and no treatment-related adverse events leading to treatment change are fulfilled. The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control.|Week 9 to Week 12|Modified Intent-to-Treat population, participants covering treatment period of at least 8 weeks and with assessable asthma control at the end of the treatment period by both criteria (GOAL, ACT), and without major protocol deviations. Only those participants available at the indicated time points were analyzed.|||Percentage|||Number
1269564|NCT00363467|Secondary|1 Year Overall Survival|Number of participants alive at 1 year posttransplant|1 year post transplant||||participants|||Number
1269565|NCT00363467|Secondary|1 Year Event-free Survival|Number of participants alive and without disease relapse at 1 year posttransplant|1 year post transplant||||participants|||Number
1269566|NCT00363467|Secondary|Severe Regimen-related Toxicity|Number of participants with severe regimen-related toxicity within 2 years posttransplant. Severe regimen-related toxicity was defined as CTC (version 3)grade 4.|up to 100 days post translant||||participants|||Number
1269567|NCT00363467|Secondary|Successful Autologous Stem Cell Collection|Number of subjects who were able to collect at least 2 million CD34+ cells/kg|At time of stem cell collection|per protocol|||participants|||Number
1269568|NCT00363467|Primary|100-day Non-relapse Mortality|100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease|100 days post transplant|"Analysis was per protocol"|||participants|||Number
1269569|NCT00363415|Post-Hoc|Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes|Number of participants with Low Density Lipoprotein <=upper limit of normal and the number of participants with a history of brain metastases. This post-hoc outcome replaces the one for Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes).|baseline to date of death due to any cause (up to 19.6 months)|Number of randomized participants.|||participants|||Number
1269655|NCT00362882|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From first day of treatment to time of death due to any cause, up to 4 years||||Months||95% Confidence Interval|Median
1271042|NCT00352053|Secondary|Change From Baseline to Week 288 in HIV-1 RNA||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
1269570|NCT00363415|Secondary|Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)|The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.|baseline to date of death due to any cause (up to 19.6 months)|The upper limit of the 95% Confidence Intervals (CI) were not calculable for these two subgroups in the etoposide+carboplatin group so medians and lower limits of the 95% CI are not presented. A post-hoc outcome measure table provides the number of participants in each subgroup.|||months||95% Confidence Interval|Median
1269571|NCT00363415|Secondary|Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy – Lung (FACT-L)|FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.|baseline and 6 cycles (21-day cycles)|Number of randomized participants with baseline and non-missing value at respective cycle.|||units on a scale||Standard Deviation|Mean
1269572|NCT00363415|Secondary|Progression Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline to measured progressive disease (up to 14.7 months)|All randomized participants. Number of participants censored: 113 in Pemetrexed+Carboplatin; 150 in Etoposide+Carboplatin.|||months||95% Confidence Interval|Median
1269573|NCT00363415|Secondary|Overall Survival (Subgroups)|The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.|baseline to date of death from any cause (up to 19.6 months)|Number of randomized participants.|||months||95% Confidence Interval|Median
1269574|NCT00363415|Primary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 19.6 months)|Number of participants with events. In the pemetrexed+carboplatin group, 242 participants were censored. In the etoposide+carboplatin group, 288 participants were censored.|||months||95% Confidence Interval|Median
1269575|NCT00363311|Secondary|Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)|"The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I feel close to my friends., I get emotional support from my family., I get support from my friends., My family has accepted my illness., I am satisfied with family communication about my illness., I feel close to my partner (or the person who is my main support)., I am satisfied with my sex life. The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156."|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269576|NCT00363311|Secondary|Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)|"The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I have a lack of energy., I have nausea., Because of my physical condition, I have trouble meeting the needs of my family., I have pain., I am bothered by side effects of treatment., I feel ill., I am forced to spend time in bed. The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life."|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269577|NCT00363311|Secondary|Percent Change From Baseline in Total FACT-P Score (LOCF)|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269578|NCT00363311|Secondary|Change From Baseline in Total FACT-P Score (LOCF)|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.|Baseline and Months 18 and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269579|NCT00363311|Secondary|Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1270118|NCT00359788|Secondary|FEV1 at 4 Hours at Week 12||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1269580|NCT00363311|Secondary|Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)|"The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269581|NCT00363311|Secondary|Total MAX-PC Fear of Recurrence Subscale Score|"The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269582|NCT00363311|Secondary|Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)|"The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269583|NCT00363311|Secondary|Total MAX-PC Anxiety Subscale Score Related to PSA Testing|"The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269584|NCT00363311|Secondary|Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF|The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269585|NCT00363311|Secondary|Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)|The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.|Baseline and Month 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
1269586|NCT00363311|Secondary|Percent Change From Baseline in Prostate Volume at Years 1.5 and 3|"Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study.|||percent change||Standard Deviation|Mean
1269587|NCT00363311|Secondary|Change From Baseline in Prostate Volume at Years 1.5 and 3|"Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study.|||cc||Standard Deviation|Mean
1269588|NCT00363311|Secondary|Prostate Volume (PV) LOCF|"Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study. Last observation carried forward (LOCF) was used.|||cubic centimeters (cc)||Standard Deviation|Mean
1271043|NCT00352053|Secondary|Change From Baseline to Week 240 in HIV-1 RNA||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
1269589|NCT00363311|Secondary|Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage|"All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as No Worsening."|Months 0-18|ITT Population. As the study progressed, participants dropped out of the study.|||biopsies|||Number
1269590|NCT00363311|Secondary|Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline|All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen [PSA]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.|Baseline|ITT Population|||biopsies|||Number
1269591|NCT00363311|Secondary|Number of Participants With the Indicated Total Gleason Score|All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.|Years 0-3 (Final Biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
1269592|NCT00363311|Secondary|Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3|The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).|Years 0-3 (Final Biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
1269593|NCT00363311|Secondary|Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5|The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).|Year 1.5|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
1269594|NCT00363311|Secondary|Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||millimeters||Standard Deviation|Mean
1269595|NCT00363311|Secondary|Cumulative Length of Cancer Tumor Core|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) * total tumor length/number of evaluated cores.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||millimeters||Standard Deviation|Mean
1269596|NCT00363311|Secondary|Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores).|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||percentage of cores||Standard Deviation|Mean
1269597|NCT00363311|Secondary|Mean Percentage of Cancer-positive Cores in a 12-core Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100* number of positive cores/number of evaluated cores).|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||percentage of cores||Standard Deviation|Mean
1269598|NCT00363311|Secondary|Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||cores||Standard Deviation|Mean
1271044|NCT00352053|Secondary|Change From Baseline to Week 192 in HIV-1 RNA||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
1269599|NCT00363311|Secondary|Number of Cancer-positive Cores in a 12-core Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||cores||Standard Deviation|Mean
1269600|NCT00363311|Secondary|Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.|Years 0-3|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
1269601|NCT00363311|Secondary|Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis|All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.|Baseline to Month 18|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
1269602|NCT00363311|Secondary|Number of Participants With Pathologic Progression|Pathological progression is defined as one of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.|Year 1.5 and Overall (Years 0-3)|ITT Population. As the study progressed, participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.|||participants|||Number
1269603|NCT00363311|Secondary|Number of Participants With Therapeutic Progression|Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.|Year 1.5 and Overall (Years 0-3)|ITT Population|||participants|||Number
1269604|NCT00363311|Primary|Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression|PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.|Year 1.5 and Overall (Years 0-3)|ITT Population: all participants randomized to study treatment. Some participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.|||participants|||Number
1269605|NCT00363298|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score|"Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as subclinical, though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed remission. A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a responder criterion in clinical trials."|At end of week 5, except 1 d-amphetamine subject rated at end of week 2|Subjects who entered the 4-week double-blind study continuation phase, including a last observation carried forward for the one d-amphetamine subject who dropped out of this phase at the end of study week 2 (end of the first week of the continuation phase) for lack of efficacy.|||units on a scale||Standard Deviation|Mean
1269606|NCT00363298|Primary|Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2|Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).|At end of week 5, except 1 d-amphetamine subject rated at end of week 2|Subjects who met the study continuation phase entry criterion of >20% decrease in Y-BOCS score after 1 week of double-blind study medication, and entered this 4-week double-blind continuation phase|||participants|||Number
1269607|NCT00363246|Primary|Wheelchair-related Falls|Wheelchair-related falls in 1 year follow-up period.|one year follow-up period|Older veterans who use a wheelchair for their primary means of mobility.|||participants|||Number
1269608|NCT00363246|Secondary|Injuries From Wheelchair-related Falls|Wheelchair-related falls that resulted in an injury in the one year follow up period|one year follow-up period|Older veterans who use a wheelchair for their primary means of mobility. Analyzed for wheelchair-related fall injury during 1-year follow-up period.|||participants|||Number
1269656|NCT00362882|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 years||||percentage of participants|||Number
1269609|NCT00363168|Secondary|Number of Subjects Experiencing Complications Related to Drug or Its Administration|"Potential complications included:~Deterioration of best-corrected visual acuity by 3 or more lines~Development of intraocular inflammation~Development of elevated intraocular pressure~Development of other ocular or systemic adverse effects.~Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function."|12 months after last injection||||participants|||Number
1269610|NCT00363168|Secondary|Fluorescein Leakage on Fluorescein Angiography||12 months|||||||
1269611|NCT00363168|Secondary|Retinal Thickness Measured by Optical Coherence Tomography (OCT)||12 months|||||||
1269612|NCT00363168|Secondary|Retinal Changes on Funduscopy||12 months|||||||
1269613|NCT00363168|Primary|Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.|Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.|12 months||||participants|||Number
1269614|NCT00363142|Secondary|Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24|Blood samples were drawn at weeks 12 and 24 to determine the plasma levels of APV and RTV. Concentration at the end of the dosing interval at steady state (Ctau) was presented.|Weeks 12 and 24|PK Parameter (Ctau) Population - Participants in the ITT-E Population who underwent PK sampling and had evaluable APV or RTV Ctau data.|||micrograms/mL||95% Confidence Interval|Geometric Mean
1269615|NCT00363142|Secondary|Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline|A blood sample was drawn for subjects failing to respond to therapy and the mutations present in the virus were identified. For each subject, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class.|Baseline through Week 24|Participants in the ITT-E Population who met the virologic failure definition|||Participants|||Number
1269616|NCT00363142|Secondary|Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24|A blood sample was drawn to determine the LDL level at Week 24. Percent change in LDL was defined as (LDL level at Week 24 minus level at baseline) divided by level at baseline x 100%.|Baseline and Week 24|Safety Population|||Percent change||Full Range|Median
1269617|NCT00363142|Secondary|Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24|A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%.|Baseline and Week 24|Safety Population|||Percent change||Full Range|Median
1269618|NCT00363142|Secondary|Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24|The number of participants who experienced any grades 2 to 4 adverse events was tabulated. Adverse events were graded based on the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.|Baseline through Week 24|Safety Population|||participants|||Number
1269619|NCT00363142|Secondary|Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24|The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event. Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline through Week 24|Safety Population: all randomized subjects who consumed at least one dose of study drug and was analyzed according to the treatment received.|||participants|||Number
1269620|NCT00363142|Secondary|Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis|A blood sample was drawn to determine the CD4+ cell count at week 24. Change from baseline was defined as CD4+ cell count at Week 24 minus CD4+ cell count at baseline.|Baseline and Week 24|ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24|||cells/mm3||Full Range|Median
1269621|NCT00363142|Secondary|Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. Change from baseline was defined as plasma HIV-1 RNA level at Week 24 minus plasma HIV-1 RNA level at baseline.|Baseline and Week 24|ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24|||log10 copies/mL||Standard Deviation|Mean
1269622|NCT00363142|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants plasma with HIV-1 RNA <50 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.|Week 24|ITT-E Population|||Percentage of participants|||Number
1269623|NCT00363142|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants with plasma HIV-1 RNA <400 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.|Week 24|ITT-E Population|||Percentage of participants|||Number
1269657|NCT00362817|Secondary|Quality of Life Assessment|To determine the impact of treatment on quality of life.|up to 2 years|Quality of Life Assessment was not done.||||||
1269624|NCT00363142|Primary|Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24|Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.|Week 24|Intent-to-Treat Exposed (ITT-E) Population. Subjects who received at least one dose of investigational product.|||Percentage of participants|||Number
1269625|NCT00363129|Secondary|Duration of Sensory Peripheral Neuropathy ≥ Grade 2|Duration of sensory peripheral neuropathy is the time from onset of grade 2+ neuropathy until the neuropathy is resolved to grade 1 or less during chemotherapy treatment.|6 months post completion of chemotherapy treatment||||days||95% Confidence Interval|Median
1269626|NCT00363129|Secondary|Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2|Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.|6 months post completion of chemotherapy treatment||||days||95% Confidence Interval|Median
1269627|NCT00363129|Secondary|Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy||6 months post completion of chemotherapy treatment||||percentage of participants|||Number
1269628|NCT00363129|Secondary|Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy||6 months post completion of chemotherapy treatment||||percentage of patients|||Number
1269629|NCT00363129|Primary|Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2|The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.|6 months post completion of chemotherapy treatment|Participants who received at least one dose of assigned therapy.|||percentage of participants|||Number
1269630|NCT00363077|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE considered by the investigator to have a causal relationship to study vaccination.|During the entire study period (from Day 0 to Day 29)|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.|||subjects|||Number
1269631|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.|||subjects|||Number
1269632|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.|||subjects|||Number
1269633|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.|||subjects|||Number
1269634|NCT00363077|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||cytokine-positive cells/million cells||Standard Deviation|Geometric Mean
1269635|NCT00363077|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||cytokine-positive cells/million cells||Standard Deviation|Geometric Mean
1269658|NCT00362817|Secondary|The Incidence and Severity of Centeral Nervous System (CNS) Toxicities|To determine the incidence and severity of CNS toxicity in patients treated with intra-arterial carboplatin and oral temozolomide.|up to 24 weeks||||patients|||Number
1269659|NCT00362817|Secondary|Determine the Cause of Death of Patients After Treatment|To determine the cause of death (i.e., CNS tumor versus systemic disease progression) in patients after treatment.|up to 1 year||||patients|||Number
1269636|NCT00363077|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||fold increase||95% Confidence Interval|Geometric Mean
1269637|NCT00363077|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||subjects|||Number
1269638|NCT00363077|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||subjects|||Number
1269639|NCT00363077|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||titers||95% Confidence Interval|Geometric Mean
1269640|NCT00363051|Secondary|Effect of Octreotide Depot on the Trough Concentrations of Everolimus|The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.|Cycle 1 Day 1, Cycle 2 Day 1|Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with Octreotide Depot pharmacokinetic samples, with nonzero concentration, at Cycle 1 Day 1 or Cycle 2 Day 1 were included.|||ng/ml||Standard Deviation|Mean
1269641|NCT00363051|Secondary|Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)|For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.|Cycle 1 Day 15|Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with everolimus pharmacokinteic samples, with nonzero concentration, at Cycle 1 Day 15 were included|||ng/ml||Standard Deviation|Mean
1269642|NCT00363051|Secondary|Time to Overall Survival (OS) (Stratum 2)|"Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.~If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed."|from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012|The full analysis set consisted of all patients who received at least one dose of everolimus.|||months||95% Confidence Interval|Median
1269643|NCT00363051|Secondary|Time to Overall Survival (OS)(Stratum 1)|"Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.~If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed."|from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012|The full analysis set consisted of all patients who received at least one dose of everolimus.|||months||95% Confidence Interval|Median
1269644|NCT00363051|Secondary|Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.~Median PFS was obtained and displayed along with 95% confidence intervals."|from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.|||Months||95% Confidence Interval|Median
1269645|NCT00363051|Secondary|Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.~Median PFS was obtained and displayed along with 95% confidence intervals."|from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.|||Months||95% Confidence Interval|Median
1269660|NCT00362817|Secondary|Determine the Overall Survival of Patients|From the time of protocol initiation|up to 64 weeks||||weeks||Full Range|Mean
1271045|NCT00352053|Secondary|Change From Baseline to Week 144 in HIV-1 RNA||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
1269646|NCT00363051|Secondary|Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month|The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.|||Participants|||Number
1269647|NCT00363051|Secondary|Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month|The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.|||Participants|||Number
1269648|NCT00363051|Secondary|Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)|Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus.|||percentage of participants||95% Confidence Interval|Number
1269649|NCT00363051|Secondary|Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review|"Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):~Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.~Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.~Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions"|from date of first documented confirmed response to time to progression, at least 3 months|Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated.||||||
1269650|NCT00363051|Secondary|Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review|"Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):~Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.~Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.~Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions"|from date of first documented confirmed response to time to progression, at least 3 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis.|||Months||95% Confidence Interval|Median
1269651|NCT00363051|Primary|Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.|||percentage of participants||95% Confidence Interval|Number
1269652|NCT00363038|Primary|Average Bruise Change|Mean change in bruising level detected by dermatologist rater on Visual Analogue Scale at 2 weeks compared with baseline for each of the four agents (Petrolatum USP, Vitamin K and retinol ointment, Vitamin K ointment, Arnica ointment). When responding to a VAS item, respondents specify the bruise severity by indicating a position along a continuous line between two end-points (0 and 10, 10 being the most bruised).|Baseline and 2 weeks||||Units on a Scale||Standard Deviation|Mean
1269653|NCT00362882|Secondary|Progression-free Survival @ 6 Months|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months||||percent of participants|||Number
1269654|NCT00362882|Secondary|Disease Control Rate|Disease control rate was defined as the rate of partial response (PR) plus stable disease (SD; for at least 2 cycles).|Up to 4 years||||percentage of participants|||Number
1269661|NCT00362817|Secondary|Analyze Patients Time to Progression|"Responses to treatment was determined by comparing new enhanced MRI scans with those obtained at the previous evaluation (i.e., 2 treatment cycles ago) or with the pre-IA chemotherapy baseline scan, if it is the first follow-up MRI scan during treatment.~MRI is the neuro-imaging modality of choice, since it is more accurate than CT for small tumors, multiple tumors, and tumors in the posterior fossa.58 The methodology used (techniques and equipment) must be identical for all scans. Lesions should be measured as the largest diameter seen on scan and the largest diameter perpendicular to that dimension."|up to 60 weeks||||weeks||Full Range|Mean
1269662|NCT00362817|Primary|Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide|Response was evaluated by MRI Criteria (MacDonald Criteria). The MacDonald criteria for determining tumor progression is determined through assessing the increase in size of an enhancing tumor on consecutive MRI scans and clinical assessment. Complete response occurs when there is a disappearance of all enhancing tumor on consecutive MRI scans at least one month apart. Partial response occurs at a >50% reduction in size of enhancing tumor on consecutive MRI scans at least one month apart. Progressive disease occurs when there is a >25% increase in size of enhancing tumor on consecutive MRI scans. Stable disease occurs in all remaining situations.|up to 1 year||||percentage of patients with response|||Number
1269663|NCT00362648|Secondary|Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]|Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)|14 days following the 3rd vaccination|Per Protocol Population|||Subjects|||Number
1269664|NCT00362648|Secondary|Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]|Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)|14 days following the 3rd vaccination|"Per Protocol Population~*N analyzed for Serotype P1A[8] is 188"|||Subjects|||Number
1269665|NCT00362648|Primary|Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose||At least 14 days following the third vaccination|Per Protocol Population|||Subjects|||Number
1269666|NCT00362609|Secondary|Half Life|Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.|1 day|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.|||hours||Standard Deviation|Mean
1269667|NCT00362609|Secondary|Apparent Oral Clearance (Cl/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling.|1 day|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.|||L/hr/kg||Standard Deviation|Mean
1269668|NCT00362609|Secondary|Area Under the Concentration-time Curve (AUC)|AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.|Baseline to 24 hours post dose on Day 1|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.|||ng*hr/mL||Standard Deviation|Mean
1269669|NCT00362609|Primary|Variance of Oral Bioavailability|Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was >1.2.|1 day|Single dose PK Valid-For Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and taken the test article on the date the PK samples were taken). 2 poor metabolizers were excluded from this analysis.|||ratio|||Number
1269670|NCT00362466|Secondary|Best MMR Rates|MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene.|throughout study|This analysis was not done. This study was terminated due to insufficient enrollment.|||participants|||Number
1269671|NCT00362466|Secondary|Duration of CCyR and MMR|Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death.|Throughout the study|This analysis was not done. This study was terminated due to insufficient enrollment.|||months|||Number
1269672|NCT00362466|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.|All treated participants|||events|||Number
1269673|NCT00362466|Secondary|Progression Free Survival (PFS)|PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization.|at 36 months|This analysis was not done. This study was terminated due to insufficient enrollment.|||participants|||Number
1269674|NCT00362466|Secondary|Estimate Time to MMR and CCyR|Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR.|throughout the study|This analysis was not done. This study was terminated due to insufficient enrollment.|||months|||Number
1269675|NCT00362466|Secondary|CCyR Rates|CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.|Month 3, Month 12, Month 24 and Month 36|This analysis was not done. This study was terminated due to insufficient enrollment.|||Participants|||Number
1269676|NCT00362466|Secondary|Major Molecular Response (MMR) Rates|MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene.|Month 3, Month 6, Month 12, Month 24 and Month 36|This analysis was not done. This study was terminated due to insufficient enrollment.|||participants|||Number
1269677|NCT00362466|Primary|Complete Cytogenetic Response (CCyR) Rate at Month 6|Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.|Month 6|This analysis was not done. This study was terminated due to insufficient enrollment.|||participants|||Number
1269678|NCT00362453|Secondary|Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component|Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Mental Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.|baseline to 12, 24, 48 weeks||||units on a scale||95% Confidence Interval|Mean
1269679|NCT00362453|Secondary|Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks.|Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Physical Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.|baseline, 12, 24, 48 weeks||||units on a scale||95% Confidence Interval|Mean
1269680|NCT00362453|Secondary|Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks.|"Self-efficacy is important for individuals to adopt and maintain a program of regular physical activity. The patient rates his/her confidence of being physically active in different types of situations on a 5-item scale with responses ranging from not at all confident to extremely confident. The total score is coputed by calculating the average of all 5 questions. A higher score indicates greater self-efficacy. Higher numbers reported here indicate more improvement from baseline."|baseline to 12, 24, 48 weeks||||units on a scale||95% Confidence Interval|Mean
1269681|NCT00362453|Secondary|Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks.|The CES-D was used to assess depressive symptoms. It included a 20-item Likert-type scale with scores ranging from 0 to 60. Higher scores indicated greater dysphoria. Negative numbers reported here indicate improvement in condition from baseline. (So -1 indicates a 1-point improvement from baseline.)|baseline to 12, 24, 48 weeks||||units on a scale||95% Confidence Interval|Mean
1269682|NCT00362453|Secondary|Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.|The standing balance test included tandem, semi-tandem, side-by-side, and one-legged stands. Patients were asked to maintain each position for 30 seconds. For each task, the research staff first demonstrated the task, asked the patient if they felt comfortable and ready and then supported the patient while positioning themselves. One point was given if they exceeded 30 seconds and none if they could not or did not attempt the test. Higher numbers reported here indicate more improvement from baseline.|baseline to 12, 24, 48 weeks|Note: Data for only 19 patients in Attention Control group was analyzed for 48-week timepoint due to availability of data.|||units on a scale||95% Confidence Interval|Mean
1269683|NCT00362453|Secondary|Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.|The 6 minute walk test is a reliable measure of functional exercise capacity. Patients were asked to walk as fast and as far as possible within the 6-minute period and were accompanied by the research staff using a wheel measure that measured distance covered in inches and convereted to yards; higher scores indicated improved state. Higher numbers reported here indicate more improvement from baseline.|baseline to 12, 24, 48 weeks|Note: Data for only 18 patients from Tai chi group was analyzed for 12 week timepoint. Data for 19 patients from the Attention Control group was analyzed at 48 week timepoint.|||yards||95% Confidence Interval|Mean
1269684|NCT00362453|Secondary|Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.|Timed stand tests measure the time taken to complete ten full stands from a sitting position. Patients began the chair stand seated with their arms folded across their chests, then rose to a standing position and sat back down with their back against the back rest of the chair. The test was completed when the patient stood for the tenth repetition. Chair stand time was measured in seconds, with lower scores indicating improved state. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-second improvement from baseline.)|baseline to 12, 24, 48 weeks|Note: Data for only 18 participants in the Attention Control group was analyzed for the 48-week timepoint to do availability of data.|||seconds||95% Confidence Interval|Mean
1269980|NCT00360334|Secondary|Percent of Patients Achieving HbA1c < 7%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.|||Percentage of participants|||Number
1269685|NCT00362453|Secondary|Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.|The study physician who was blinded to group assignment completed a global knee pain assessment VAS with scores ranging from 0 to 10cm; 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)|baseline to 12, 24, 48 weeks|Note: Data for only 19 participants in the Attention Control group was analyzed at 48 Weeks due to lack of available data.|||cm||95% Confidence Interval|Mean
1269686|NCT00362453|Secondary|Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)|Participants completed a self-reported knee-specific global pain VAS with scores ranging from 0 to 10 centimeters (cm); 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)|baseline to 12, 24, 48 weeks||||cm||95% Confidence Interval|Mean
1269687|NCT00362453|Secondary|Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The WOMAC was administered to the participants at baseline, 12, 24 and 48 weeks. The pain subscale score range was 0-500mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)|baseline to 24, 48 weeks|The 12-Week WOMAC scores are listed under Primary Outcome. The 24-Week and 48-Week scores are listed as Secondary Outcomes.|||mm||95% Confidence Interval|Mean
1269688|NCT00362453|Secondary|Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The stiffness subscale has a score range 0-200mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)|baseline to 12, 24, 48 weeks||||mm||95% Confidence Interval|Mean
1269689|NCT00362453|Secondary|Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The function subscale had a score range 0-1700mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)|from baseline to 12, 24, 48 weeks||||mm||95% Confidence Interval|Mean
1269690|NCT00362453|Primary|Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks|WOMAC scale range: 0 millimeters (no pain) to 500 millimeters (severe pain), ordinal. Change: score at 12 weeks minus score at baseline. Negative numbers reported here indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)|between baseline and 12 weeks.|We analyzed the data on an intent-to-treat basis.|||mm||95% Confidence Interval|Mean
1269691|NCT00362440|Secondary|Body Composition (Fat Mass)||At the end of each 3 month intervention||||kg||Standard Error|Mean
1269692|NCT00362440|Secondary|Cholesterol Levels||At the end of each 3 month intervention||||mg/dl||Standard Error|Mean
1269693|NCT00362440|Primary|Insulin Resistance (HOMA Index)||At the end of each 3 month intervention||||units on a scale||Standard Error|Mean
1269694|NCT00362414|Secondary|Trail Making B Test|Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.|3 mo.||||correct connections||Full Range|Median
1269695|NCT00362414|Secondary|Trail Making A Test|Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.|3 mo||||correct connections||Full Range|Median
1269696|NCT00362414|Secondary|Infarct Volume Using Anatomical MRI|Measurement of infarct volume and percent change from baseline to Day 90.|3 mo||||percent change||Standard Error|Mean
1269697|NCT00362414|Secondary|Barthel Index|Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence.|3 mo||||Units on a scale||Full Range|Median
1269698|NCT00362414|Secondary|Geriatric Depression Scale Short Form|Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression.|3 mo||||Units on a scale||Full Range|Median
1269699|NCT00362414|Secondary|NIH Stroke Scale|Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke.|3 mo||||Units on a scale||Full Range|Median
1269700|NCT00362414|Secondary|Line Cancellation Test|Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect.|3 mo||||ratio of canceled lines on each side||Full Range|Median
1269701|NCT00362414|Secondary|Boston Naming Test|Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture.|3 mo||||Units on a scale||Full Range|Median
1269702|NCT00362414|Secondary|Fugl-Meyer Leg Scale|"Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered normal."|3 mo.||||Units on a scale||Full Range|Median
1269703|NCT00362414|Secondary|Fugl-Meyer Arm Scale|"Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered normal with no impairments."|3 mo||||Units on a scale||Full Range|Median
1269772|NCT00361972|Secondary|Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement|Change in TNF alpha cytokine expression from bronchoalveolar lavage aspirate samples between lansoprazole and placebo groups, measured in log picograms per milliliter (log (pg/mL)) units, pre- and post-intervention.|Baseline and 6 weeks||||log (pg/mL)||Inter-Quartile Range|Median
1269704|NCT00362414|Secondary|Action Research Arm Test|"The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered normal."|3 mo|This number (9) is the total # subjects who could complete the test at all study time points; some subjects were unable to complete this test at one of the time points, especially the acute stroke assessment.|||Units on a scale||Full Range|Median
1269705|NCT00362414|Primary|Mortality|attributable to experimental intervention|3 mo||||participants|||Number
1269706|NCT00362414|Primary|Morbidity|attributable to experimental intervention|3 mo||||participants|||Number
1269707|NCT00362414|Primary|Safety|Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.|3 mo||||participants|||Number
1269708|NCT00362401|Primary|Intensity (Highness) of the Sound From Mechanical Heart Valves|The measurements took place in a Bioacoustic laboratory. The total background noise was 9 dB(A). The valve closing sounds were recorded by a microphone placed 5 cm above the patient’s chest. This sound was pre-amplified, amplified, filtered and stored on an instrumentation recorder for later off-line analysis.|10.06.2007|Patients with a mechanical heart valve prosthesis recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.|||dB (decibel)||Standard Deviation|Mean
1269709|NCT00362375|Secondary|Knowledge of HIV Test||current|||||||
1269710|NCT00362375|Secondary|Condom Use Self-efficacy||current|||||||
1269711|NCT00362375|Secondary|HIV Knowledge||current|||||||
1269712|NCT00362375|Secondary|HIV Testing and Receipt of Results|Percentage of women who reported testing for HIV infection and received their test results during the past 3 months|Past 3 months|Based on the number of women who provided data at the 3-month follow-up|||Percent|||Number
1269713|NCT00362375|Other Pre-specified|Number of Male Sex Partners|The number of male sex partners during the past 3 months|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up|||Number of sex partners||Standard Deviation|Mean
1269714|NCT00362375|Other Pre-specified|Unprotected Vaginal Sex With Any Male Partner|The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up|||Percent|||Number
1269715|NCT00362375|Other Pre-specified|Sexual Abstinence|The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up|||Percent|||Number
1269716|NCT00362375|Primary|Condom Use During Vaginal Sex With Any Male Partner|Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months|Past 3 months|Women who were sexually active at 3-month follow-up and who provided data on outcome measure|||Percent|||Number
1269717|NCT00362336|Secondary|Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 post-booster vaccination|Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received (Safety Analysis Population).|||Participants|||Number
1269718|NCT00362336|Secondary|Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable.|Day 0 up to Day 7 post each dose|Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received - Safety Analysis Population.|||Participants|||Number
1269719|NCT00362336|Secondary|Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.|Day 540 pre-booster and Day 570, post-booster|GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1269755|NCT00362115|Secondary|Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-36-hour mean systolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269720|NCT00362336|Secondary|Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV|Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA.|Day 540 pre-booster and Day 570 post-booster|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
1269721|NCT00362336|Secondary|Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.|Day 42 before Dose 1 and 1 month post-Dose 3|GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1269722|NCT00362336|Secondary|Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline.|1 month post-Dose 3|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
1269723|NCT00362336|Primary|Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).|1 month post-Dose 3|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
1269724|NCT00362297|Secondary|Number of Herpes Recurrences, Defined Clinically as >=1 Successive Day on Which Genital Lesions Are Present, in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks|||||||
1269725|NCT00362297|Secondary|Frequency of Lesional Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per Day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks|||||||
1269726|NCT00362297|Secondary|Frequency of Subclinical Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks|||||||
1269727|NCT00362297|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.|Participants were treated with both interventions in a cross-over study design. Shedding rates on each drug arm per participant were compared by Poisson regression.|15 weeks|Participants who did not collect at least one swab on each arm of the cross-over were excluded from analysis.|||percentage of swabs with HSV detected|||Number
1269728|NCT00362232|Secondary|Treatment-emergent Major Bleedings Per Safety Population.|Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)|from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).|The safety population comprised those subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
1269729|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
1269730|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
1269731|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
1269732|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
1269733|NCT00362232|Secondary|The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions|Up to 47 days after surgery|The net clinical benefit population comprised all subjects either valid for MITT analysis of major VTE or who showed treatment-emergent major bleeding.|||percentage of participants|||Number
1269734|NCT00362232|Secondary|Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 47 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
1269735|NCT00362232|Secondary|Incidence of Symptomatic VTE During Follow-up Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 47 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
1269736|NCT00362232|Secondary|Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
1269737|NCT00362232|Secondary|Incidence of DVT (Proximal, Distal) Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
1269738|NCT00362232|Secondary|Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
1269739|NCT00362232|Secondary|Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
1269740|NCT00362232|Secondary|Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
1269770|NCT00362115|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure.|The change in sitting clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 8|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1269741|NCT00362232|Secondary|Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.|||percentage of participants|||Number
1269742|NCT00362232|Primary|Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||Percentage of participants|||Number
1269743|NCT00362232|Primary|Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The primary efficacy analysis was based on the per protocol (PP) population and included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.|||Percentage of participants|||Number
1269744|NCT00362180|Secondary|Percent Change in Total Cholesterol From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.|||percent change||Inter-Quartile Range|Median
1269745|NCT00362180|Secondary|Baseline Total Cholesterol|Samples were taken following an overnight fast.|Baseline|Full analysis set|||mg/wk||Inter-Quartile Range|Median
1269746|NCT00362180|Secondary|Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.|||percent change||Inter-Quartile Range|Median
1269747|NCT00362180|Secondary|Baseline Low-Density Lipoprotein Cholesterol|Samples were taken following overnight fast.|Baseline|Full analysis set|||mg/wk||Inter-Quartile Range|Median
1269748|NCT00362180|Secondary|Percent Change in Apolipoprotein B From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.|||percent change||Inter-Quartile Range|Median
1269749|NCT00362180|Secondary|Baseline Apolipoprotein B|Samples were taken following an overnight fast.|Baseline|Full analysis set|||mg/wk||Inter-Quartile Range|Median
1269750|NCT00362180|Primary|Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)|Localized proton MRS was used to quantify liver TG concentration. All MRS imaging of the liver was performed using the same 1.5T scanner. The instructions were to cover the entire liver (from just above the dome to just below the inferior tip) using a qualified imaging technique (Yokoo, 2009, Radiology). Liver fat quantification was performed by determining the liver fat fraction (%) derived from MRS using selected Regions of Interest (ROI). The analyst typically looked for the branching of the right portal vein and mapped slices from one scan to the next. There were typically 2 ROIs in the right lobe and 1 in the left lobe. Magnetic resonance spectroscopy imaging ROIs between different scans were selected using anatomical landmarks for both time points.|Baseline, Day 26, Day 99|Full analysis set. In Cohort E: Placebo, Day 99 N=11 instead of 10 because participant did not have a post treatment MRS by Day 26.|||percentage of total liver content||Full Range|Median
1269751|NCT00362128|Primary|Number of Participants With Hypertension|Systolic BP above 129 or Diastolic BP above 79.|4 years||||participants|||Number
1269752|NCT00362115|Secondary|Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 34-36-hour mean diastolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269753|NCT00362115|Secondary|Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 34-36-hour mean systolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.|Baseline and Week 8|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269754|NCT00362115|Secondary|Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-36-hour mean diastolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269771|NCT00362115|Primary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure.|The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1269756|NCT00362115|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269757|NCT00362115|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269758|NCT00362115|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269759|NCT00362115|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269760|NCT00362115|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269761|NCT00362115|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269762|NCT00362115|Secondary|Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 10 to 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269763|NCT00362115|Secondary|Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 10 to 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269764|NCT00362115|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269765|NCT00362115|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269766|NCT00362115|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269767|NCT00362115|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1269768|NCT00362115|Secondary|Change From Baseline in Standing Clinic Diastolic Blood Pressure.|The change in standing clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough standing diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1269769|NCT00362115|Secondary|Change From Baseline in Standing Clinic Systolic Blood Pressure.|The change in standing clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough standing systolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1271046|NCT00352053|Secondary|Change From Baseline to Week 96 in HIV-1 RNA||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
1269773|NCT00361972|Primary|Change in Lymphocyte Count|Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.|Baseline and 6 weeks||||Lymphocytes per square millimeter||Standard Deviation|Mean
1269774|NCT00361712|Primary|Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth|Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery|At birth of parturients||||pg/ml||Standard Deviation|Mean
1269775|NCT00361712|Primary|Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery|Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery|24 hours after delivery||||pg/ml||Standard Deviation|Mean
1269776|NCT00361712|Primary|Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment|Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment|Right after enrollment||||pg/ml||Standard Deviation|Mean
1269777|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 85|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 85 and from Day -28 to Day 1|Day -28 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
1269778|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 57|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 57 and from Day -28 to Day 1|Day -28 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
1269779|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 29|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 29 and from Day -28 to Day 1|Day -28 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
1269780|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 85|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 85 and from study day -28 to study day 1|Day -28 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
1269781|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 57|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 57 and from study day -28 to study day 1.|Day -28 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
1269782|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 29|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 29 and from study day -28 to study day 1.|Day -28 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
1269783|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-85|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 85. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269784|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-57|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 57. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269785|NCT00361634|Primary|Percent Change in the Synovial Initial Area Under the Contrast-Time Curve (IAUC) From Days 1-85|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 85. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269786|NCT00361634|Primary|Percent Change in the Synovial Initial Area Under the Contrast-Tme Curve (IAUC) From Days 1-57|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 57. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269787|NCT00361634|Primary|Percent Change in Synovial Initial Area Under the (Contrast-time) Curve (IAUC) From Days 1-29|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 29. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269788|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-85|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 85. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, increases in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269789|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-57|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 57. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269790|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-29|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 29. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269791|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-29|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 29. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available Day 29 data are included in the analysis.|||Percent change||Standard Deviation|Mean
1269792|NCT00361595|Secondary|Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)|Change in serum n-propeptide type 1 collagen (P1NP) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.|12 months||||mcg/ml||Standard Deviation|Mean
1269793|NCT00361595|Secondary|Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)|Change in serum c-telopeptide type 1 collagen (CTX) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.|12 months||||ng/ml||Standard Deviation|Mean
1269794|NCT00361595|Secondary|Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months|Change in bone density (grams/cm^2) at the total hip at 6 and 12 months. 12 month reported based on usual interval for bone density follow-up in clinical practice.|6 months and 12 months||||grams/cm^2||Standard Deviation|Mean
1269795|NCT00361595|Primary|Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)||Baseline and 12 months||||grams/cm^2||Standard Deviation|Mean
1269796|NCT00361569|Secondary|Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)|Any adverse event reported from the beginning of the 28-day screening through the subject's last report.|Up to Week 12|All randomized subjects who received at least one dose of study medication|||Participants|||Number
1269797|NCT00361569|Primary|Mean Change in Maturation Index|Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)|Baseline to Week 12|Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints|||Index||Standard Error|Least Squares Mean
1269798|NCT00361569|Primary|Mean Change in Vaginal pH|Change= Week 12 vaginal pH - Baseline vaginal pH|Baseline to Week 12|Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints|||pH||Standard Error|Least Squares Mean
1269981|NCT00360334|Secondary|Percent of Patients Achieving HbA1c ≤ 7.4%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.|||Percentage of participants|||Number
1269799|NCT00361569|Primary|Mean Change in the Symptom Identified by the Patient to be Most Bothersome|Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.|Baseline to Week 12|Modifed Intent-to-Treat: All subjects meeting study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, randomized to treatment, received at least 1 dose of study drug, and had a baseline assessment and at least 1 post-randomization assessment of vulvovaginal atrophy consisting of all 3 co-primary efficacy endpoints|||Scores on a scale||Standard Error|Least Squares Mean
1269800|NCT00361504|Secondary|Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)|"The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52."|Baseline, Week 52|intent-to-treat|||Scores on a Scale||Standard Deviation|Mean
1269801|NCT00361504|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|52 weeks|Safety analysis set (All randomized participants who took at least one dose of study medication).|||Participants|||Number
1269802|NCT00361439|Secondary|Change From Baseline in Percentage of Eosinophils at 2 Weeks|"A decrease between visits signifies a reduction in inflammation.~Calculated from cytology specimens obtained by lavage."|baseline and 2 weeks||||percentage of eosinophils||Full Range|Median
1269803|NCT00361439|Secondary|Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks|An increase between visits indicates improved nasal airflow.|baseline and 2 weeks||||liters per minute||Full Range|Median
1269804|NCT00361439|Secondary|Change From Baseline in Total Nasal Symptom Score at 2 Weeks|A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27.|baseline and 2 weeks||||units on a scale||Full Range|Median
1269805|NCT00361439|Primary|Histological Findings|Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported|2 weeks||||eosinophils per HPF||Full Range|Median
1269806|NCT00361374|Primary|Score on a Depression Severity Rating Scale Over Eight Weeks|Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models.|8 weeks|We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects|||units on a scale||Standard Error|Mean
1269807|NCT00361335|Secondary|Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14|The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.|Weeks 0 to Week 14|Intent to treat (ITT). Missing components were imputed by the median component value of all patients in the same Stratum at baseline, and last observation carried forward (LOCF) at Week 14|||Units on a scale||Standard Deviation|Mean
1269808|NCT00361335|Secondary|Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14|"DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient’s assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A Good response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A “Moderate” response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2"|Week 0 to Week 14|Intent to treat. Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing components were imputed by the median component value of all patients in the same stratum unless all components are missing in which case considered non-responders.|||Participants|||Number
1269809|NCT00361335|Secondary|Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).|Week 0 to Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.|||Participants|||Number
1269982|NCT00360334|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
1269810|NCT00361335|Secondary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).|Week 0 to Week 24||||Participants|||Number
1269811|NCT00361335|Primary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14|An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).|Week 0 to Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.|||Participants|||Number
1269812|NCT00361296|Secondary|Combined Immune and Clinical Response Rate|Number of participants who exhibited both an immune response as defined by Outcome 3 and a hematologic or cytogenetic response as defined by Outcomes 1 and 2, respectively.|Week 21 post-intervention||||Participants|||Count of Participants
1269813|NCT00361296|Secondary|Immune Response Rate as Assessed by Number of Participants Who Exhibit Induced Immune Response to WT-1, Survivin, or Proteinase-3|Immune response to WT-1, survivin, or proteinase-3 as defined by a 30% increase from baseline in cytotoxic T cells measured by Elispot analysis.|Baseline, week 21 post-intervention||||Participants|||Count of Participants
1269814|NCT00361296|Primary|Cytogenetic Response Rate as Assessed by Number of Participants Achieving a Cytogenetic Response|Cytogenetic response is defined as normalization of pretreatment cytogenetic abnormalities.|Week 21||||Participants|||Count of Participants
1269815|NCT00361296|Primary|Hematologic Response Rate as Assessed by Number of Participants Achieving a Major Hematologic Response|A major hematologic response is defined as any of the following: hemoglobin increase >= 2 g/dL from baseline; platelet increase >= 30k/mcL from baseline; or neutrophil increase >= 100% or >= 500/mcL from baseline.|Baseline, week 21 post-intervention||||Participants|||Count of Participants
1269816|NCT00361283|Primary|Mean Change in Level: Week 16-baseline in Ena-78|We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.|16 weeks after baseline|Power calculation|||pg/ml||Standard Deviation|Mean
1269817|NCT00361270|Secondary|Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)|The change score is the difference between pre-treatment scores on the Pittsburgh Sleep Quality Index (PSQI) and the 1-week post-treatment scores. Positive values indicate a reduction in sleep problems. The PSQI was scored on 19 items with 7 component scores ranging from 0 no difficulty falling asleep to 3 severe difficulty, then component scores added to create global score ranging from 0 no difficulty falling asleep to 21 severe difficulty falling asleep.|Subjects change on this scale from Pre-treatment to 1-week post treatment||||units on a scale||Standard Deviation|Mean
1269818|NCT00361270|Secondary|Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale|The change score measures the difference between pre-treatment scores on the Brief Pain Inventory-Interference Scale (NRS: 0 no interference - 10 complete interference) and 1- week post treatment scores for the 10 items. Change is calculated as pre-treatment minus post treatment.|Subjects change on this scale from Pre-Treatment to 1-week post treatment||||units on a scale||Standard Deviation|Mean
1269819|NCT00361270|Primary|Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale|The change score measures the difference between Pre-Treatment Brief Pain Inventory Pain Intensity Scale scores (Numerical Rating Scale (NRS): 0 no pain - 10 worst pain) and the 1-week Post--Treatment Brief Pain Inventory-Pain Intensity Scale scores for 4 items. Change is calculated as pre-treatment minus post treatment.|Subjects change on this scale from Pre-Treatment to 1 week post treatment||||units on a scale||Standard Deviation|Mean
1269820|NCT00361257|Secondary|Changes in Alternate Frontal Systems Z-Score|The alternate frontal systems was defined as a mean of age and education adjusted z score of Interference task, and age, sex, education, and African-American ethnicity adjusted z score of Trail Making Part B. The outcome was the 24 week change in alternate frontal systems z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
1269821|NCT00361257|Secondary|Changes in Alternate Verbal Memory Z-Score|The alternate verbal memory was defined as a mean of age and education adjusted z score of trials 1 to 3 and delayed recall tests. The outcome is the 24 week change in alternate verbal memory z-score (week 24-baseline).|At baseline and week 24|The analysis is based on observed data.|||z-score||Standard Deviation|Mean
1269822|NCT00361257|Secondary|Changes in Alternate Psychomotor Function Z-Score|The alternate psychomotor function is defined as the mean of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA), and age and education adjusted z score of Symbol Digit (SYD). The outcome is the 24 week change in alternate psychomotor function z-score (week 24-baseline).|At baseline and week 24|The analysis was based on the observed data.|||z-score||Standard Deviation|Mean
1269823|NCT00361257|Secondary|Changes in Neurotransmitter Levels (Unit = uM Only)|Neurotransmitter levels (Glutamate, Tryptophan, Anthranilic Acid, Quinolinic Acid, Kynurenin, and 3-Hydroxykynurenine). The outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.|||uM||Inter-Quartile Range|Median
1269824|NCT00361257|Secondary|Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only)|Protein marker of oxidative stress (Neurofilament heavy polypeptide). The outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.|||Pixels/mm^2||Inter-Quartile Range|Median
1271138|NCT00351936|Primary|Change From Baseline in Weight (Lbs)|Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||lbs||Standard Deviation|Mean
1269825|NCT00361257|Secondary|Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only)|Protein markers of oxidative stress (Protein carbonyls) and markers of immune activation (TNF-a, IL-6,CXCL8, Hepatocyte growth factor, Osteopontin, sFAS, sFAS ligand, and CXCL12). For all markers, the outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.|||pg/mL||Inter-Quartile Range|Median
1269826|NCT00361257|Secondary|Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only)|Protein marker of oxidative stress (Ceramides, Monohexosylceramides, Dihydro Glycosyl Galceramides, and Dihexosylceramides). For all markers, the outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.|||counts per second||Inter-Quartile Range|Median
1269827|NCT00361257|Secondary|Changes in Medication Management Test (Modified)|The medication management test (modified) is designed to assess participants' medication management ability and their own medications and management. It’s the number of how many times participants correctly answered 16 questions. The score ranges between 0 and 16, and higher score indicates better medication management.|At baseline and weeks 24|The analysis was based on observed data.|||scores on a scale||Standard Deviation|Mean
1269828|NCT00361257|Secondary|Changes in Instrumental Activities of Daily Living Questionnaire|The Instrumental Activities of Daily Living (IADL) questionnaire is designed to learn more about how subjects are able to perform common tasks. There are 16 common tasks. For each task, if the score at the time of evaluation is worse than the best in the past, an indicator of 1 is given. Otherwise, the indicator is 0. The overall IADL score is a sum of 16 indicators divided by 16; therefore, the range is between 0 and 1 and the lower score is better. The 24-week change of IADL score was changed into a categorical variable (no change/worse vs. better) at week 24 compare to baseline.|At baseline and week 24|The analysis was based on observed data.|||participants|||Number
1269829|NCT00361257|Secondary|Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load|The original scale of HIV RNA viral load is between 30 copies/mL to infinitive. The minimum score of 30 is the lowest detectable value. The summary table categorized this continuous value to a dichotomous variable (<30 copies/mL and >= 30 copies/mL).|At baseline and week 24|The summary statistics were based on observed data. No statistical analysis was conducted.|||participants|||Number
1269830|NCT00361257|Secondary|Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms|Grade or higher means that adverse events were moderate, severe, or life-threatening, or death. Grade 2 or higher adverse events are lised in the Adverse Event section.|Throughout study up to week 48|The analysis includes all randomized participants. A total of 37 minocycline and 38 placebo participants reported Grade 2 or higher toxicity and/or signs and symptoms during 48 weeks.|||participants with an event|||Number
1269831|NCT00361257|Secondary|Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks)|The outcome was the 24 week change of CD8 cell counts (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||cells/mm^3||Standard Deviation|Mean
1269832|NCT00361257|Secondary|Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks)|The outcome was the 24 week change in CD4 cell count (week 24-baseline).|At baseline and weeks 24|The analysis was based on observed data.|||cells/mm^3||Standard Deviation|Mean
1269833|NCT00361257|Secondary|Change in Karnofsky Performance Score|"The original Karnofsky performance score is 11 level score which ranges between 0 to 100. The score 100 means normal and 0 means death; therefore, higher score means higher ability to perform daily tasks.~For the analysis, a new dichotomous variable (no change/worse vs. better at 24 weeks compared to baseline) was created."|At baseline and week 24|The analysis was based on observed data.|||participants|||Number
1269834|NCT00361257|Secondary|Change in Frontal Systems Function Domain Z-Score|The frontal systems function domain score is the average of age and education adjusted z scores of Stroop Color Interference Test (CTP) and interference task (STP). The outcome is the 24 week change of frontal systems function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
1269835|NCT00361257|Secondary|Change in Verbal Memory Domain Z-Score|The verbal memory domain score is the average of age and education adjusted z scores of Hopkins Verbal Learning Test- Revised, Learning and Delayed Recall. The outcome is the 24 week change of verbal memory domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
1269836|NCT00361257|Secondary|Change in Information Processing Function Domain Z-Score|The information processing function domain score is the average of age and education adjusted z scores of simple and sequential reaction time - CalCAP. The outcome is the 24 week change of information processing function domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
1269837|NCT00361257|Secondary|Change in Fine Motor/Nonverbal Function Domain Z-Score|The fine motor/nonverbal function domain score is a age and education adjusted z score of Symbol Digit Test (SYD) The outcome is the 24 change of fine motor/nonverbal function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
1269838|NCT00361257|Secondary|Change in Psychomotor Function Domain Z-Score|The psychomotor function domain score us the average of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA) and Trail Making Part B (TMB). The outcome is the 24 week change of psychomotor function domain z-scores (week24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
1269839|NCT00361257|Secondary|Change in Fine Motor Function Domain Z-Score|The fine motor function domain score is an average of age, sex, education, and African-American ethnicity adjusted z scores of Grooved Pegboard Dominant Hand (GPD) and Grooved Pegboard Non-dominant hand (GPN). The outcome is a 24 week change of the fine motor function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
1269840|NCT00361257|Secondary|Change in Cognitive Gross Motor Function Domain Z-Score|The cognitive gross motor function is a age and education adjusted z score of Timed Gait (TIG). The outcome is the 24 week change of cognitive gross motor function domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on the observed data.|||z-score||Standard Deviation|Mean
1269841|NCT00361257|Secondary|Change in Investigator's Clinical Global Impression Score (ICGIS)|"Clinicians were asked to rate their overall impression about the clinical improvement or worsening of his/her study participants. They can choose from the following 7 levels: (0) No Change, (1) Mild Improvement, (2) Moderate Improvement, (3) Marked Improvement, (4) Mild Worsening, (5) Moderate Worsening, and (6) Marked Worsening.~For the analysis, we simplified the outcome into the following 3 levels: (0) worsened, (1) No Change, and (2) Improved."|At week 24|The analysis was based on observed data.|||participants|||Number
1269842|NCT00361257|Secondary|Change in Global Deficit Z-Score (GDS)|GDS on the test battery is the simple average of all 14 individual deficit scores in the test battery, including Time Gait, Grooved Pegboard Test for the dominant and non-dominant hands, Trail Making Test parts A and B, Symbol Digit Test, simple and sequential reaction time - CalCAP, Hopkins Verbal Learning Test (Revised)- Learning, Delayed Recall and Recognition trials, and Stroop Color Interference Test-color, word, and interference tasks. The outcome is the 24 week change of GDS Z-score (24 week-baseline).|At baseline and week 24|The analysis was based on the observed data.|||z-score||Standard Deviation|Mean
1269843|NCT00361257|Primary|Change in Cognitive Performance Compared to Baseline|"Th cognitive performance is measured by NPZ-8. NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery. These eight tests are:~Grooved Pegboard Dominant Hand (GPD)~Grooved Pegboard Non-dominant hand (GPN)~Choice Reaction Time (CRT)~Sequential Reaction Time (QRT)~Timed Gait (TIG)~Trail Making Part A (TMA)~Trail Making Part B (TMB)~Symbol Digit (SYD) The primary outcome is NPZ-8 score at week24 - NPZ-8 score at baseline."|At baseline and week 24|The descriptive statistics above were based on the observed data; however, the statistical analysis was conducted by the ITT analysis and the missing outcomes at week 24 were imputed based on multiple regression imputations.|||z-score||Standard Deviation|Mean
1269844|NCT00361231|Secondary|Overall Response Rate|To assess the overall response rate of GEMOX-B in patients with advanced BTC. Response rate is determined through Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||percentage of participants|||Number
1269845|NCT00361231|Primary|Median Progression Free Survival|To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.|2 years||||months||95% Confidence Interval|Median
1269846|NCT00361218|Primary|Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response|"Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation.~Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression)."|8 weeks|QEEG data were collected, analyzed and reported as part of a larger trial. The analysis of QEEG data per protocol was only possible using the proprietary algorithm developed by a company; acquisition of that company precludes analysis for this study alone. Larger study reported in: Iosifescu DV et al. Eur Neuropsychopharmacol. 2009;19:772-7.||||||
1269847|NCT00361218|Primary|Serum Brain-derived Neurotrophic Factor (BDNF) Levels|"Pre-SSRI BDNF Level refers to the data collection point before SSRI intake and Post-SSRI BDNF Level refers to the data collection point 8 weeks after SSRI intake."|8 weeks||||pg/mL||Standard Deviation|Mean
1269848|NCT00361140|Primary|Non-relapse Mortality|The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.|100 days|Intent to treat|||participants|||Number
1269849|NCT00361140|Secondary|Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)|The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant.|100 days|Intent to treat|||participants|||Number
1269850|NCT00360971|Secondary|Time to Second Primary Tumor|An event is occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no events. Number of patients with an event is reported.|From randomization to maximum follow-up at time of analysis of 21 months|Randomized patients who started protocol treatment|||Participants|||Count of Participants
1269851|NCT00360971|Secondary|Progression-free Survival|An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported.|From randomization to maximum follow-up at time of analysis of 21 months|Randomized patients who started protocol treatment|||Participants|||Count of Participants
1269852|NCT00360971|Secondary|Overall Survival|An event is death from any cause. Overall survival was not calculated due to the limited number of events. Number of patients with an event is reported.|From randomization to maximum follow-up at time of analysis of 21 months|Randomized patients who started protocol treatment|||Participants|||Count of Participants
1269853|NCT00360971|Secondary|Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Twice-weekly from start of treatment up to 15 weeks after the start of treatment.|All randomized patients|||days||Standard Deviation|Mean
1269971|NCT00360334|Secondary|Percent of Patients Achieving 10% Weight Loss|Percent of patients who lost at least 10% of baseline body weight at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.|||Percentage of participants|||Number
1269854|NCT00360971|Secondary|Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Twice-weekly from start of treatment up to 15 weeks after the start of treatment.|All randomized patients|||Participants|||Count of Participants
1269855|NCT00360971|Primary|Duration of Oral Mucositis as Measured in Terms of Days|"Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days [15 weeks] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0.~This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05.~Statistical testing was not done due to the small sample size."|Twice-weekly from start of treatment up to 15 weeks after the start of treatment.|All eligible patients.|||Days||Standard Deviation|Mean
1269856|NCT00360828|Secondary|Overall Survival at 12 Months|Patients surviving 12 months after last dose of drug|12 months post treatment end|All participants who received at least one dose of drug|||participants|||Number
1269857|NCT00360828|Secondary|Frequency and Severity of Toxicity|Toxicities assessed through 3 months|3 months|The low accrual rate prevented us from completing the planned analysis.||||||
1269858|NCT00360828|Secondary|Progression Free Survival|Patients surviving at one year post treatment end|1 year post treatment end|The low accrual rate prevented us from completing the planned analysis.||||||
1269859|NCT00360828|Secondary|Overall Survival at 6 Months|Patients surviving 6 months after treatment end|6 months post treatment end|All participants who received at least one dose of drug|||participants|||Number
1269860|NCT00360828|Primary|Number of Participants With Objective Response After 3 Cycles of Treatment|The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.|3 cycles (21 day cycles)|All participants having stable disease|||participants|||Number
1269861|NCT00360724|Other Pre-specified|Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)|To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.|Follow up||||percentage of connecting nods||Standard Deviation|Mean
1269862|NCT00360724|Other Pre-specified|Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)|To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.|Baseline||||percentage of connecting nods||Standard Deviation|Mean
1269863|NCT00360724|Secondary|Global Assessment of Functioning Scale (GAF)|"A commonly used rating scale for global social function.~Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).~61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others~1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.~0 Inadequate information"|Baseline|subjects for whom post-baseline data were available|||points on rating scale||Standard Deviation|Mean
1269864|NCT00360724|Secondary|Beck Depression Inventory (BDI)|"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.~When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|Baseline|subjects for whom post-baseline data was available|||Scores on a scale||Standard Deviation|Mean
1269865|NCT00360724|Secondary|Cornell Dysthymia Rating Scale (CDRS)|"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).~Scores from 0 to 82 with higher score indicating worse depression"|Baseline|subjects for whom data post baseline were available|||Scores on a scale||Standard Deviation|Mean
1269866|NCT00360724|Secondary|Clinical Global Impressions Improvement(CGI-I)|"The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline.~0 = Not assessed~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse Higher score=greatest worsening"|10 weeks|subjects for whom post-baseline data was available|||Scores on a scale||Standard Deviation|Mean
1269867|NCT00360724|Secondary|Beck Depression Inventory (BDI)|"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.~When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|Week 10|subjects fro whom post-baseline data was available|||Scores on a scale||Standard Deviation|Mean
1269972|NCT00360334|Secondary|Percent of Patients Achieving 5% Weight Loss|Percent of patients who lost at least 5% of baseline body weight at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.|||Percentage of participants|||Number
1269868|NCT00360724|Secondary|Global Assessment of Functioning Scale (GAF)|"A commonly used rating scale for global social function.~Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).~61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others~1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.~0 Inadequate information"|Week 10|subjects for whom post-baseline data were available|||points on rating scale||Standard Deviation|Mean
1269869|NCT00360724|Secondary|Cornell Dysthymia Rating Scale (CDRS)|"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).~Scores from 0 to 82 with higher score indicating worse depression"|Week 10|subjects for whom data post baseline were available|||scores on a scale||Standard Deviation|Mean
1269870|NCT00360724|Primary|Hamilton Depression Rating Scale (HDRS) - 24 Total Score|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Baseline|Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.|||Scores on a scale||Standard Deviation|Mean
1269871|NCT00360724|Primary|Hamilton Depression Rating Scale (HDRS) - 24 Total Score|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Week 10|Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.|||Scores on a scale||Standard Deviation|Mean
1269872|NCT00360698|Secondary|Rate of Severe Symptomatic Hypoglycemia||during treatment period (12 weeks)|Safety population|||Number of hypoglycemia per patient-year||Standard Deviation|Mean
1269873|NCT00360698|Secondary|Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL||during treatment period (12 weeks)|Safety population|||Number of hypoglycemia per patient-year||Standard Deviation|Mean
1269874|NCT00360698|Secondary|Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL||during treatment period (12 weeks)|Safety population|||Number of hypoglycemia per patient-year||Standard Deviation|Mean
1269875|NCT00360698|Secondary|Daily Dose of Insulin Glulisine|Mean of 3 daily doses reported during the week prior to the final visit|at the end of treatment (week 24)|Modified ITT population, LOCF|||units of insulin glulisine per day||Standard Deviation|Mean
1269876|NCT00360698|Secondary|Daily Dose of Insulin Glargine|Mean of 3 daily doses reported during the week prior to the final visit|at the end of treatment (week 24)|Modified ITT population, LOCF|||units of insulin glargine per day||Standard Deviation|Mean
1269877|NCT00360698|Secondary|Change in Weight||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF|||kg||Standard Error|Least Squares Mean
1269878|NCT00360698|Secondary|Change in Daily Mean Plasma Glucose||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF|||mg/dL||Standard Error|Least Squares Mean
1269879|NCT00360698|Secondary|Daily Mean Plasma Glucose||at the end of treatment (week 24)|Modified ITT population, LOCF|||mg/dL||Standard Deviation|Mean
1269880|NCT00360698|Secondary|Change in Glycosylated Haemoglobin (HbA1c) Value||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF|||percent||Standard Error|Least Squares Mean
1269881|NCT00360698|Secondary|Glycosylated Haemoglobin (HbA1c) Value||at the end of treatment (week 24)|Modified ITT population, LOCF|||percent||Standard Deviation|Mean
1269882|NCT00360698|Primary|Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%|Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%|at the end of treatment (week 24)|Modified Intent to treat (ITT) population, LOCF (Last Observation Carried Forward)|||percentage of participants|||Number
1269883|NCT00360685|Secondary|Overall Survival|number of participants alive at one year|1 year|intent to treat|||participants|||Number
1269884|NCT00360685|Secondary|Incidence of Acute Graft-vs-host Disease (aGVHD)|incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation|100 days post transplant|intent to treat|||participants|||Number
1269885|NCT00360685|Primary|Incidence of Severe Mucositis|Mucositis was assessed prospectively daily while the patient was hospitalized and graded retrospectively based on nurse and clinician assessments according to the clinical criteria set forth in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0). Severe mucositis as defined as grade 3 or grade 4.|2 year|Intent to treat|||participants|||Number
1269886|NCT00360672|Primary|Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses)|Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) >1 * 10^9/L, platelet count ≥100 * 10^9/L, < 5% of blast cells in bone marrow. CRp: as above except platelet count <100 * 10^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.|Following three 28-day cycles evaluated for response||||participants|||Number
1269930|NCT00360490|Secondary|Percentage of Patients With Improvement in the Patients Overall Assessment Scale|“Improved” is classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” is classified as ‘no change’, ‘worse’, ‘much worse’, or ‘very much worse’.|Up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.|||percentage|||Number
1269887|NCT00360568|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Endpoint (Month 12 months or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269888|NCT00360568|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint|The EQ-5D VAS records the participant's self-rated health on a scale from 0–100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269889|NCT00360568|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269890|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269891|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269892|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269893|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269894|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269895|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269896|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269897|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269898|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269899|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269900|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269901|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269902|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269958|NCT00360334|Secondary|Nocturnal Hypoglycemic Rate Per 30 Days|Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set|||Number of episodes per 30 days||Inter-Quartile Range|Median
1269973|NCT00360334|Secondary|Percent Change in Body Weight|Percent change in baseline body weight at endpoint|26 Weeks|Full Analysis Set|||Percentage||Standard Error|Least Squares Mean
1269903|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1269904|NCT00360568|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment; n=number of participants with assessment at timepoint.|||units on a scale||Standard Deviation|Mean
1269905|NCT00360568|Secondary|"Change From Baseline in Average Daily On Time Without Troublesome Dyskinesia at Month 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. “On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Deviation|Mean
1269906|NCT00360568|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Deviation|Mean
1269907|NCT00360568|Secondary|"Change From Baseline in Average Daily Off Time at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Deviation|Mean
1269908|NCT00360568|Primary|Number of Participants Taking at Least 1 Concomitant Medication During the Study|Concomitant medications include medications started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
1269909|NCT00360568|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS) Findings|The Columbia-Suicide Severity Rating Scale (C-SSRS) is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.|up to 12 months|Safety Data Set: all enrolled participants who received at least one study S187-3-3003 LCIG infusion with a C-SSRS assessment during the study.|||participants|||Number
1269910|NCT00360568|Primary|Number of Participants With Clinically Significant Neurological Examination Findings|"The neurologic examination was to be done during On time. The neurological examination assessed: cranial nerves – assessment of cranial nerves II – XII, excluding fundoscopic examination; motor system – assessment of tone, strength, and abnormal movements; sensory system – including light touch, pinprick, joint position, and vibratory sense; reflexes – assessment of deep tendon reflexes and plantar responses (Babinski sign); coordination – assessment of upper and lower extremities; gait – assessment of base and tandem gait; station – assessment of posture and stability."|up to 12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had a neurological examination.|||participants|||Number
1269911|NCT00360568|Primary|Number of Participants With Confirmed Cases of Melanoma|A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination/end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.|up to Month 12|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
1269912|NCT00360568|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint|"The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions concerning problems with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst On time (dyskinesia [involuntary muscle movement])."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.|||units on a scale||Standard Deviation|Mean
1269913|NCT00360568|Primary|Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)|The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire-setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.|Baseline, Post-baseline (up to Month 12)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.|||participants|||Number
1269914|NCT00360568|Primary|Number of Participants With Sleep Attacks at Baseline and Endpoint|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
1269915|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
1269916|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment.|||participants|||Number
1269917|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with an assessment.|||participants|||Number
1269918|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Terms abbreviated in the table include females (f) and males (m).|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had an assessment.|||participants|||Number
1269919|NCT00360568|Primary|Number of Participants With Device Complications|Complications of the infusion device were collected. Pump, intestinal tube, PEG, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and device site reaction.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
1269920|NCT00360568|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.|From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
1269921|NCT00360555|Primary|Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.|"Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours / since your last visit.” Potential responses included no, “low,” “moderate,” or “strong” and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:~0 = No desire~= Low desire~= Moderate desire~= Strong desire"|baseline to 24 weeks|Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.|||units on a scale||Standard Error|Least Squares Mean
1269922|NCT00360555|Primary|Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.|"For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms.~For satisfying sexual events:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)"|baseline to 28 weeks|Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.|||SSEs per 28 days||Standard Deviation|Mean
1269923|NCT00360529|Secondary|Patient Benefit Evaluation|The Patient Benefit Evaluation is a single question asking the patient whether or not she experienced a meaningful benefit from the study medication during the trial. This question (“Overall, do you believe that you have experienced a meaningful benefit from the study medication?”) was asked upon treatment discontinuation.|Week 24|This question was asked at Week 24 only, so did not include participants who had discontinued the trial prior to that time (e.g., analysis population includes treatment completers only).|||participants|||Number
1269924|NCT00360529|Secondary|Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit|The FSFI© is a self-administered questionnaire to assess FSD, which consists of 19 questions that are scored from ‘0’ to ‘5.’ The scale contains six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate higher levels of the domain assessed. The total score is a weighted average of the six domains, each contributing a maximum of 6 points to the total, so the minimum score is 2, while the maximum score of FSFI© is 36.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||score on a scale||Standard Error|Least Squares Mean
1269925|NCT00360529|Secondary|Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit|Female Sexual Function Inventory (FSFI) Desire Domain assesses sexual desire or interest with 2 questions ranging from 1 (very low) to 5 (very high). The domain total score is multiplied by 0.6 yielding scores ranging from 1.2 to 6 (higher scores = higher level of desire or interest).|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||score on a scale||Standard Error|Least Squares Mean
1269926|NCT00360529|Secondary|Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit|Change from baseline in the FSDS-R Question 13 (Bothered by low sexual desire). The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The scoring for item 13 is from 0-4, with 4 indicating the highest level of sexual distress.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||score on a scale||Standard Error|Least Squares Mean
1269927|NCT00360529|Secondary|Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit|"Change from baseline in the Female Sexual Distress Scale - revised (FSDS-R) Total Score with a seven day recall period.~The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The maximum total score of the FSDS-R is ‘52’ (score of minimum of 0 and maximum of 4 for each item) and indicates the maximum level of sexual distress (the higher the score, the higher the level of reported sexual desire)."|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||score on a scale||Standard Error|Least Squares Mean
1269928|NCT00360529|Primary|Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit|"Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours/since your last visit.” Potential responses included no, “low,” “moderate,” or “strong, scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire):~0 = No desire~= Low desire~= Moderate desire~= Strong desire~Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses)."|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||units on a scale||Standard Error|Least Squares Mean
1269929|NCT00360529|Primary|Satisfying Sexual Event Monthly Change From Baseline at Final Visit|Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||number of events||Standard Deviation|Mean
1269959|NCT00360334|Secondary|Hypoglycemic Rate Per 30 Days|Number of hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set|||Number of episodes per 30 days||Inter-Quartile Range|Median
1269974|NCT00360334|Secondary|Change in Body Weight|Change in body weight from baseline to endpoint|26 weeks|Full Analysis Set|||kg||Standard Error|Least Squares Mean
1269931|NCT00360490|Secondary|Percentage of Patients With Improvement in the Investigator Global Assessment Scale|“Improved” is classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” is classified as ‘no change’, ‘worse’, ‘much worse’, or ‘very much worse’|Up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.|||percentage|||Number
1269932|NCT00360490|Secondary|Percent Change in Serum Ferritin||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 148 subjects (75 for LNG IUS and 73 for MPA) were available for the analysis.|||percent change||Full Range|Median
1269933|NCT00360490|Secondary|Percent Change in Hematocrit||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.|||percent change||Full Range|Median
1269934|NCT00360490|Secondary|Percent Change in Hemoglobin||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.|||percent change||Full Range|Median
1269935|NCT00360490|Secondary|Total Number of Bleeding Episodes|A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.|||number of bleeding episodes||Standard Deviation|Mean
1269936|NCT00360490|Secondary|Total Number of Spotting Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.|||days||Standard Deviation|Mean
1269937|NCT00360490|Secondary|Total Number of Spotting and Bleeding Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.|||days||Standard Deviation|Mean
1269938|NCT00360490|Secondary|Total Number of Bleeding Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.|||days||Standard Deviation|Mean
1269939|NCT00360490|Secondary|Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis.|||percentage of participants|||Number
1269940|NCT00360490|Secondary|Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)|The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.|Baseline and up to 3 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||Percent change||Standard Deviation|Mean
1269941|NCT00360490|Secondary|Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)|The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.|Baseline and up to 3 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||milliliter (mL)||Full Range|Median
1269942|NCT00360490|Secondary|Percent Change From Baseline MBL to End of Study MBL (Cycle 6)|The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||Percent change||Standard Deviation|Mean
1269943|NCT00360490|Primary|Percentage of Patients With Successful Treatment|End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.|At 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||Percentage of participants|||Number
1269944|NCT00360490|Primary|The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)|The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||milliliter (mL)||Full Range|Median
1269960|NCT00360334|Secondary|Incidence of Severe Hypoglycemic Episodes|Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study|26 weeks|Full Analysis Set|||percent|||Number
1269961|NCT00360334|Secondary|Incidence of Nocturnal Hypoglycemic Episodes|Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study|26 weeks|Full Analysis Set|||percent|||Number
1269945|NCT00360412|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population|||Scores on a scale||Standard Deviation|Mean
1269946|NCT00360412|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-52. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population|||Scores on a scale||Standard Deviation|Mean
1269947|NCT00360412|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population|||Hours||Standard Deviation|Mean
1269948|NCT00360412|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population- all subjects entering the open-label extension study who took at least 1 dose of perampanel|||Hours||Standard Deviation|Mean
1269949|NCT00360399|Secondary|Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy|The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks|Measured after 12 weeks of combined treatment|Participants who did not achieve remission during monotherapy were offered 12 weeks of combination therapy. This sample consists of those participants who consented for the combination therapy part of the trial and who completed the 12 weeks of treatment.|||participants|||Number
1269950|NCT00360399|Secondary|Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment|The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.|Measured at 6, 9, 12, 15, 18, 21, and 24 months|This population is comprised of participants who completed 12 weeks of treatment, achieved remission, and participated in a follow-up phase that lasted for up to 21 months or until recurrence occurred.|||participants|||Number
1269951|NCT00360399|Secondary|Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention|"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7"|Measured at Weeks 10 and 12|This population includes participants who completed the trial, per study protocol.|||participants|||Number
1269952|NCT00360399|Secondary|Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample|"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7"|Up to 12 Weeks|The population is defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment.|||participants|||Number
1269953|NCT00360399|Primary|Remission From Major Depressive Episode Among Participants Who Completed the Intervention|The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.|Measured at Weeks 10 and 12|This population includes participants who completed the trial, per study protocol.|||percentage of participants|||Number
1269954|NCT00360399|Primary|Remission From Major Depressive Episode in Intent to Treat Sample|The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.|Up to 12 Weeks|This population consists of all participants who were randomized and returned for at least one study visit. This population was used for the intent to treat analyses and not all of these individuals completed the study.|||percentage of participants|||Number
1269955|NCT00360360|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months||||months||95% Confidence Interval|Median
1269956|NCT00360360|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||months||95% Confidence Interval|Median
1269957|NCT00360334|Secondary|Severe Hypoglycemic Rate Per 30 Days|Number of severe hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set|||Number of episodes per 30 days||Full Range|Median
1269983|NCT00360334|Secondary|Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg|Composite endpoint evaluating effect of treatment on glycemic control and weight|26 weeks|Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.|||Percentage of participants|||Number
1269984|NCT00360334|Primary|Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)|Composite endpoint evaluating effect of treatment on glycemic control and weight|26 weeks|Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.|||percentage of participants|||Number
1269985|NCT00360308|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population|||Hours||95% Confidence Interval|Least Squares Mean
1269986|NCT00360308|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1269987|NCT00360308|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. Unified Parkinson’s Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1269988|NCT00360308|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 18|The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.|||Hours||95% Confidence Interval|Least Squares Mean
1269989|NCT00360282|Secondary|Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus|Subjective report of distress ranging from 0 to 10 based on the method of Wolpe. Zero indicates no distress and 10 indicates severe distress. Measures used in this analysis match the times used in the analysis for Outcome 1.|Pre and Post Stimulus (6 minutes apart)|Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.|||units on a scale||Inter-Quartile Range|Median
1269990|NCT00360282|Primary|Change From Baseline in Motion Sickness to Post Vestibular Stimulus|Scores are based on a scale developed by Graybiel which rates seven subjective and objective signs of motion sickness. The total scores ranged from from 0 to 25. Zero indicating no motion sickness. Greater than 16 indicates severe motion sickness. Trials were stopped if scores were 16 or greater. Scores were taken before and after each rotation.|Pre and Post Stimulus (about 6 minutes apart)|Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.|||units on a scale||Inter-Quartile Range|Median
1269991|NCT00360269|Secondary|Clinical Global Impression, Improvement Scale|The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|12 weeks||||Units on a scale||Standard Deviation|Mean
1269992|NCT00360269|Secondary|Wender-Reimherr Adult Attention Deficit Disorder Scale|The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0–2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF).|Baseline and Week 12||||Units on a scale||Standard Deviation|Mean
1269993|NCT00360269|Secondary|Urine Drug Screens|Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.|12 weeks||||Percentage of positive UDS|||Number
1269994|NCT00360269|Primary|Estimated Week 12 Self-reported Use|Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.|One week (study week 12)||||Times per day||Standard Error|Mean
1269995|NCT00360269|Secondary|Self-reported Longitudinal Use|Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back.|12 weeks||||Percentage of days used||Standard Deviation|Mean
1270052|NCT00359788|Secondary|Evening PEFR at Week 6|Weekly means for evening PEFR|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1269996|NCT00360243|Primary|Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.|"Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours / since your last visit.” Potential responses included no, “low,” “moderate,” or “strong” and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:~0 = No desire~= Low desire~= Moderate desire~= Strong desire"|baseline to 24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||units on a scale||Standard Error|Least Squares Mean
1269997|NCT00360243|Primary|Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.|A small personal handheld electronic device (eDiary) was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||SSEs per week||Standard Deviation|Mean
1269998|NCT00360230|Secondary|Titers for Anti-Hepatitis B (Anti-HBs)|Titers are presented as geometric mean titers (GMTs) and expressed in milli-international units per milliliter (mIU/mL).|At Day 0 and at Month 2|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1269999|NCT00360230|Secondary|Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)|Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Day 0, at Month 2, at Month 7 and at Month 10|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1270000|NCT00360230|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available.|||Participants|||Count of Participants
1270001|NCT00360230|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available and who had their symptom sheets filled in.|||Participants|||Count of Participants
1270002|NCT00360230|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.|During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available and who had their symptom sheets filled in.|||Participants|||Count of Participants
1270003|NCT00360230|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 10|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available.|||Participants|||Count of Participants
1270004|NCT00360126|Primary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event (AE) is defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event is therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Only SAEs were recorded and reported in this extension study.|Up to 54 weeks|All subject population consisted of all participants enrolled into the study and received study drug.|||Participants|||Number
1270024|NCT00359983|Primary|Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
1270005|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Tired State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
1270006|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Tense State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
1270007|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Sad State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
1270008|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Happy State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
1270009|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Energetic State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
1270010|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Confused State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
1270011|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Afraid State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
1270012|NCT00360009|Secondary|Change in Letter Fluency Tasks (LFT)|LFT assess frontal lobe function. Performance measure is number of words beginning with a specific letter generated in 1 min. Although no range of possible scores,the more words named in allotted time,the higher the predicted frontal lobe function. Raw score is converted to T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-2.6) signifies a reduction in task performance from pre to post-DBS while a positive T-score difference(0.7) denotes an increase in task performance. The larger the absolute T-score value,the greater the mean change in performance.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
1270013|NCT00360009|Secondary|Change in Beck Depression Inventory (BDI)|BDI is a questionnaire used to measure depression. There is a four-point scale for each of the 21-items of the questionnaire with scores ranging from 0 to 3. Total raw scores range from 0 to 63. The higher the score the greater the severity of depression. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-3.7) indicates a reduction in depression from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in depression. The larger the absolute T-score value,the greater the mean change in depression.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.|||T-score||Standard Deviation|Mean
1270036|NCT00359801|Secondary|Time to Event: All-cause Mortality|Time to all-cause mortality: elapsed time, in days, from the start of a subject’s participation in the study to the date of the event subsequently confirmed (according to protocol definition) as meeting the criteria for all-cause mortality. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
1270014|NCT00360009|Secondary|Change in Spielberger State-Trait Anxiety Inventory (STAI)|STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-1.4) indicates a reduction in anxiety from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in anxiety. The larger the absolute T-score value,the greater the mean change in anxiety.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.|||T-score||Standard Deviation|Mean
1270015|NCT00360009|Primary|Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.|||T-score||Standard Deviation|Mean
1270016|NCT00359983|Secondary|Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
1270017|NCT00359983|Secondary|hSBA-MenY Geometric Mean Titers (GMTs)|"Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Titer||95% Confidence Interval|Geometric Mean
1270018|NCT00359983|Secondary|Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
1270019|NCT00359983|Secondary|hSBA-MenC Geometric Mean Titers (GMTs)|"Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Titer||95% Confidence Interval|Geometric Mean
1270020|NCT00359983|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
1270021|NCT00359983|Secondary|Anti-PRP Geometric Mean Concentrations (GMCs)|"Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL).~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1270022|NCT00359983|Primary|Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
1270023|NCT00359983|Primary|Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
1270116|NCT00359788|Secondary|FVC at 15 Minutes on Day 1||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270025|NCT00359944|Secondary|Disability Assessment for Dementia (DAD)|"Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores.~The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction."|Baseline to 16 Weeks||||units on a scale||Standard Deviation|Mean
1270026|NCT00359944|Secondary|Clinicians Interview Based Impression of Change (CIBIC)-Plus|"Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment.~CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end."|Baseline to 16 weeks||||units on a scale||Standard Deviation|Mean
1270027|NCT00359944|Primary|Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)|Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment.|Baseline to 16 weeks||||units on a scale||Standard Deviation|Mean
1270028|NCT00359801|Primary|Time to Persistent Decline in FEV1 Exceeding 20% From Baseline|Elapsed time, in days, from the start of subject’s participation in the study to the first reading of FEV1 that is: 20% or more below the subject’s latest pre-study measurement, subsequently confirmed as a >20% decline [(baseline observed value minus visit observed value)/by baseline observed value *100], and assessed as persistent as defined by protocol process. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to latest valid FEV1 measurement for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
1270029|NCT00359801|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline|Baseline HbA1c taken as the latest determination prior to beginning study participation. Change = on-study value (for measurements falling within the time window associated with a given analysis set) minus the baseline value. Linear model with terms for treatment, baseline HbA1c, time on study, and subject within treatment.|Baseline to 5 years|FAS. Due to early study termination, the originally planned inferential analysis (linear model) for change from baseline was not done.|||percent|||Number
1270030|NCT00359801|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline|Baseline HbA1c: the latest determination prior to beginning study participation. Change from Baseline: HbA1c at observation (falling within the time window associated with a given analysis set) minus the baseline value.|Baseline, Month 6, Year 1, Year 2, Index Visit|FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.|||percent||Standard Deviation|Mean
1270031|NCT00359801|Secondary|Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for allergic response. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
1270032|NCT00359801|Secondary|Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite or possible: anaphylaxis, angioedema/urticaria, bronchospasm or possible allergic reaction not otherwise specified (NOS); Insufficient: insufficient data.|Baseline through End of Study|FAS|||events|||Number
1270033|NCT00359801|Secondary|Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for cardiovascular SAE composite. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
1270034|NCT00359801|Secondary|Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke|Endpoint committee adjudicated based on review of medical/hospital records; results classified using standard criteria. Definite: definite MI or stroke; Possible: possible MI or stroke; Other (non-MI, non-stroke): other cardiovascular event (non-MI, non-stroke); Definite or possible: either definite or possible or both; Insufficient: insufficient data; Death from cardiovascular or cerebrovascular: cardiovascular or cerebrovascular event; Definite or possible or death from cardiovascular or cerebrovascular: either definite or possible or both or cardiovascular or cerebrovascular event.|Baseline through End of Study|FAS|||events|||Number
1270035|NCT00359801|Primary|Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects|Confirmed FEV1 decline: any two consecutive declines that are >= 14 days apart. The pulmonary function test that established persistence occured >= 60 days after the initial decline. A confirmed decline: any two consecutive declines ≥ 14 days apart. The third PFT that established persistence was to occur ≥ 60 days after the initial decline. Index Visit: date the subject had his/her final scheduled spirometry was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Month 6, Year 1, Year 2, Index Visit|FAS|||participants|||Number
1270037|NCT00359801|Secondary|All-cause Mortality: Number of Deaths|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria (confirmation of deaths by blinded adjudicator(s) through medical records or death certificates). Patients meeting the endpoint All Cause Mortality after adjudication by the endpoint committee.|Baseline through End of Study|FAS|||participants|||Number
1270038|NCT00359801|Secondary|Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first report of an event subsequently confirmed (according to protocol definition) as meeting the criteria for pulmonary SAE composite. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
1270039|NCT00359801|Secondary|Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite: definite pneumonia, definite COPD, or definite asthma; possible: possible pneumonia, possible COPD, possible asthma, probable obstructive lung disease not otherwise specified or probable acute bronchitis; definite or possible: either definite or possible; insufficient: insufficient data.|Baseline through End of Study|FAS|||events|||Number
1270040|NCT00359801|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Change from Baseline: mean of value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value. Index Visit: date subject had final scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Week 26, Week 52, Week 104, Index Visit|FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.|||liters||Standard Deviation|Mean
1270041|NCT00359801|Primary|Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline|Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Month 6, Year 1, Year 2, Index Visit|Full Analysis Set: all randomized subjects.|||participants|||Number
1270042|NCT00359788|Secondary|Physician Global Evaluation|The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Units on a scale||Standard Error|Least Squares Mean
1270043|NCT00359788|Secondary|Physician Global Evaluation|The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Units on a scale||Standard Error|Least Squares Mean
1270044|NCT00359788|Secondary|Patient Global Evaluation|The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Units on a scale||Standard Error|Least Squares Mean
1270045|NCT00359788|Secondary|Patient Global Evaluation|The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Units on a scale||Standard Error|Least Squares Mean
1270046|NCT00359788|Secondary|Evening PEFR at Week 12|Weekly means for evening PEFR|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270047|NCT00359788|Secondary|Evening PEFR at Week 11|Weekly means for evening PEFR|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270048|NCT00359788|Secondary|Evening PEFR at Week 10|Weekly means for evening PEFR|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270049|NCT00359788|Secondary|Evening PEFR at Week 9|Weekly means for evening PEFR|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270050|NCT00359788|Secondary|Evening PEFR at Week 8|Weekly means for evening PEFR|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270051|NCT00359788|Secondary|Evening PEFR at Week 7|Weekly means for evening PEFR|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270053|NCT00359788|Secondary|Evening PEFR at Week 5|Weekly means for evening PEFR|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270054|NCT00359788|Secondary|Evening PEFR at Week 4|Weekly means for evening PEFR|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270055|NCT00359788|Secondary|Evening PEFR at Week 3|Weekly means for evening PEFR|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270056|NCT00359788|Secondary|Evening PEFR at Week 2|Weekly means for evening PEFR|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270057|NCT00359788|Secondary|Evening PEFR at Week 1|Weekly means for evening PEFR|Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270058|NCT00359788|Secondary|Morning PEFR at Week 12|Weekly means for morning PEFR|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270059|NCT00359788|Secondary|Morning PEFR at Week 11|Weekly means for morning PEFR|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270060|NCT00359788|Secondary|Morning PEFR at Week 10|Weekly means for morning PEFR|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270061|NCT00359788|Secondary|Morning PEFR at Week 9|Weekly means for morning PEFR|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270062|NCT00359788|Secondary|Morning PEFR at Week 8|Weekly means for morning PEFR|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270063|NCT00359788|Secondary|Morning PEFR at Week 7|Weekly means for morning PEFR|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270064|NCT00359788|Secondary|Morning PEFR at Week 6|Weekly means for morning PEFR|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270065|NCT00359788|Secondary|Morning PEFR at Week 5|Weekly means for morning PEFR|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270066|NCT00359788|Secondary|Morning PEFR at Week 4|Weekly means for morning PEFR|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270067|NCT00359788|Secondary|Morning PEFR at Week 3|Weekly means for morning PEFR|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270068|NCT00359788|Secondary|Morning PEFR at Week 2|Weekly means for morning PEFR|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270069|NCT00359788|Secondary|Morning Peak Expiratory Flow Rate (PEFR) at Week 1||Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
1270070|NCT00359788|Secondary|Night Time Albuterol Use During Week 12|Puffs of rescue albuterol used during the night in week 12|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270071|NCT00359788|Secondary|Night Time Albuterol Use During Week 11|Puffs of rescue albuterol used during the night in week 11|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270072|NCT00359788|Secondary|Night Time Albuterol Use During Week 10|Puffs of rescue albuterol used during the night in week 10|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270073|NCT00359788|Secondary|Night Time Albuterol Use During Week 9|Puffs of rescue albuterol used during the night in week 9|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270074|NCT00359788|Secondary|Night Time Albuterol Use During Week 8|Puffs of rescue albuterol used during the night in week 8|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270075|NCT00359788|Secondary|Night Time Albuterol Use During Week 7|Puffs of rescue albuterol used during the night in week 7|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270076|NCT00359788|Secondary|Night Time Albuterol Use During Week 6|Puffs of rescue albuterol used during the night in week 6|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270077|NCT00359788|Secondary|Night Time Albuterol Use During Week 5|Puffs of rescue albuterol used during the night in week 5|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270078|NCT00359788|Secondary|Night Time Albuterol Use During Week 4|Puffs of rescue albuterol used during the night in week 4|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270079|NCT00359788|Secondary|Night Time Albuterol Use During Week 3|Puffs of rescue albuterol used during the night in week 3|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270080|NCT00359788|Secondary|Night Time Albuterol Use During Week 2|Puffs of rescue albuterol used during the night in week 2|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270081|NCT00359788|Secondary|Night Time Albuterol Use During Week 1||Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
1270082|NCT00359788|Secondary|Day Time Albuterol Use During Week 12|Puffs of rescue albuterol used during the day in week 12|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270083|NCT00359788|Secondary|Day Time Albuterol Use During Week 11|Puffs of rescue albuterol used during the day in week 11|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270084|NCT00359788|Secondary|Day Time Albuterol Use During Week 10|Puffs of rescue albuterol used during the day in week 10|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270085|NCT00359788|Secondary|Day Time Albuterol Use During Week 9|Puffs of rescue albuterol used during the day in week 9|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270086|NCT00359788|Secondary|Day Time Albuterol Use During Week 8|Puffs of rescue albuterol used during the day in week 8|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270087|NCT00359788|Secondary|Day Time Albuterol Use During Week 7|Puffs of rescue albuterol used during the day in week 7|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270088|NCT00359788|Secondary|Day Time Albuterol Use During Week 6|Puffs of rescue albuterol used during the day in week 6|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270089|NCT00359788|Secondary|Day Time Albuterol Use During Week 5|Puffs of rescue albuterol used during the day in week 5|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270090|NCT00359788|Secondary|Day Time Albuterol Use During Week 4|Puffs of rescue albuterol used during the day in week 4|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270091|NCT00359788|Secondary|Day Time Albuterol Use During Week 3|Puffs of rescue albuterol used during the day in week 3|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270092|NCT00359788|Secondary|Day Time Albuterol Use During Week 2|Puffs of rescue albuterol used during the day in week 2|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1280667|NCT00263887|Secondary|The Deterioration of the Lung Function Will be Assessed by Measurement of the Change in Forced Expiratory Volume at One Second (FEV1) and Transfer Factor of Carbon Monoxide (KCO)||24 or 30 months|||||||
1270093|NCT00359788|Secondary|Day Time Albuterol Use During Week 1|Puffs of rescue albuterol used during the day in week 1|Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
1270094|NCT00359788|Secondary|FVC at 6 Hours at Week 12||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270095|NCT00359788|Secondary|FVC at 4 Hours at Week 12||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270096|NCT00359788|Secondary|FVC at 3 Hours at Week 12||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270097|NCT00359788|Secondary|FVC at 2 Hours at Week 12||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270098|NCT00359788|Secondary|FVC at 1 Hour at Week 12||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270099|NCT00359788|Secondary|FVC at 30 Minutes at Week 12||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270100|NCT00359788|Secondary|FVC at 15 Minutes at Week 12||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270101|NCT00359788|Secondary|FVC at -10 Minutes at Week 12||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270102|NCT00359788|Secondary|FVC at 6 Hours at Week 6||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270103|NCT00359788|Secondary|FVC at 4 Hours at Week 6||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270104|NCT00359788|Secondary|FVC at 3 Hours at Week 6||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270105|NCT00359788|Secondary|FVC at 2 Hours at Week 6||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270106|NCT00359788|Secondary|FVC at 1 Hour at Week 6||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270107|NCT00359788|Secondary|FVC at 30 Minutes at Week 6||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270108|NCT00359788|Secondary|FVC at 15 Minutes at Week 6||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270109|NCT00359788|Secondary|FVC at -10 Minutes at Week 6||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270110|NCT00359788|Secondary|FVC at 6 Hours on Day 1||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270111|NCT00359788|Secondary|FVC at 4 Hours on Day 1||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270112|NCT00359788|Secondary|FVC at 3 Hours on Day 1||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270113|NCT00359788|Secondary|FVC at 2 Hours on Day 1||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270114|NCT00359788|Secondary|FVC at 1 Hour on Day 1||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270115|NCT00359788|Secondary|FVC at 30 Minutes on Day 1||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1280668|NCT00263887|Secondary|The Frequency of Exacerbations as Determined by Patient Diary.||24 or 30 months|||||||
1270119|NCT00359788|Secondary|FEV1 at 3 Hours at Week 12||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270120|NCT00359788|Secondary|FEV1 at 2 Hours at Week 12||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270121|NCT00359788|Secondary|FEV1 at 1 Hour at Week 12||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270122|NCT00359788|Secondary|FEV1 at 30 Minutes at Week 12||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270123|NCT00359788|Secondary|FEV1 at 15 Minutes at Week 12||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270124|NCT00359788|Secondary|FEV1 at -10 Minutes at Week 12||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270125|NCT00359788|Secondary|FEV1 at 6 Hours at Week 6||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270126|NCT00359788|Secondary|FEV1 at 4 Hours at Week 6||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270127|NCT00359788|Secondary|FEV1 at 3 Hours at Week 6||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270128|NCT00359788|Secondary|FEV1 at 2 Hours at Week 6||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270129|NCT00359788|Secondary|FEV1 at 1 Hour at Week 6||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270130|NCT00359788|Secondary|FEV1 at 30 Minutes at Week 6||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270131|NCT00359788|Secondary|FEV1 at 15 Minutes at Week 6||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270132|NCT00359788|Secondary|FEV1 at -10 Minutes at Week 6||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270133|NCT00359788|Secondary|FEV1 at 6 Hours on Day 1||6 hours|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270134|NCT00359788|Secondary|FEV1 at 4 Hours on Day 1||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270135|NCT00359788|Secondary|FEV1 at 3 Hours on Day 1||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270136|NCT00359788|Secondary|FEV1 at 2 Hours on Day 1||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Least Squares Mean||Standard Error|Least Squares Mean
1270137|NCT00359788|Secondary|FEV1 at 1 Hour on Day 1||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270138|NCT00359788|Secondary|FEV1 at 30 Minutes on Day 1||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270139|NCT00359788|Secondary|FEV1 at 15 Minutes on Day 1||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270140|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270189|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.|From Month 0 to Month 24|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1270141|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|baseline and 6 Weeks (after first dose)|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270142|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270143|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks|Average hourly FVC AUC0-6 minus baseline FVC|Baseline and 6 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270144|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1|Average hourly FVC AUC0-6 minus baseline FVC|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270145|NCT00359788|Secondary|Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks|Trough FVC is measured 10 minutes before drug administration|Baseline and 6 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270146|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks|Average hourly FVC AUC0-6 minus baseline FVC|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270147|NCT00359788|Secondary|Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks|Trough FVC is measured 10 minutes before drug administration|Baseline and 12 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270148|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Baseline and 12 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270149|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Baseline and 6 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270150|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270151|NCT00359788|Secondary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6|Average hourly FEV1 AUC0-6 minus baseline FEV1|Baseline and week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270152|NCT00359788|Secondary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1|Average hourly FEV1 AUC0-6 minus baseline FEV1|Day 1 (after first dose)|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270153|NCT00359788|Secondary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks|Trough FEV1 is measured 10 minutes before drug administration|Baseline and 6 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270154|NCT00359788|Primary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks|Average hourly FEV1 AUC0-6 minus baseline FEV1|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270155|NCT00359788|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks|Trough FEV1 is measured 10 minutes before drug administration|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1270156|NCT00359762|Secondary|Hypoglycemia Rate Per Year in Period III|All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.|Start of Period III to end of study|Extension ITT Safety Population: Extension enrolled patients receiving at least one dose of study medication in Study Period III.|||events per subject-year||Standard Deviation|Mean
1270157|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III|Change in HbA1c from baseline to Year 2.|Baseline in Period III, Year 2 in Period III|Extension ITT Efficacy population. The analysis included patients not randomized at entry in study period III. Missing data at Year 2 was not imputed.|||percentage of total hemoglobin||Standard Deviation|Mean
1270158|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III|Change in HbA1c from baseline to Year 2.|Baseline in Period III, Year 2 in Period III|Extension ITT Efficacy Population: Extension enrolled patients with at least one post-baseline measurement of HbA1c in Study Period III. The analysis included patients randomized at entry in study period III. Missing data at Year 2 was not imputed.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1270159|NCT00359762|Secondary|Hypoglycemia Rate Per Year|All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.|Baseline to end of Period II (up to 4.5 years)|ITT Safety Population.|||events per subject-year||Standard Error|Least Squares Mean
1270160|NCT00359762|Secondary|High-density Lipoprotein (HDL) Cholesterol at Year 3|HDL Cholesterol at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
1270161|NCT00359762|Secondary|Total Cholesterol at Year 3|Total Cholesterol at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
1270162|NCT00359762|Secondary|Triglycerides at Year 3|Triglycerides at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
1270163|NCT00359762|Secondary|Heart Rate at Year 3|Heart rate at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||beats per minute||Standard Error|Least Squares Mean
1270164|NCT00359762|Secondary|Diastolic Blood Pressure at Year 3|Diastolic Blood pressure at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmHg||Standard Error|Least Squares Mean
1270165|NCT00359762|Secondary|Systolic Blood Pressure at Year 3|Systolic Blood pressure at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmHg||Standard Error|Least Squares Mean
1270166|NCT00359762|Secondary|Change in Body Weight From Baseline to Year 3|Change in Body weight from baseline to Year 3.|Baseline, Year 3 in Period II|ITT Safety Population: Enrolled patients receiving at least one dose of study medication in Study Period II with patients analyzed according to treatment actually received. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||kg||Standard Error|Least Squares Mean
1270167|NCT00359762|Secondary|Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint|Change from baseline in postprandial (2 hours) plasma glucose to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||mmol/L||Standard Error|Least Squares Mean
1270168|NCT00359762|Secondary|Postprandial (2 Hours) Plasma Glucose at Year 3|Postprandial (2 hours) plasma glucose at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
1270169|NCT00359762|Secondary|Change in Fasting Plasma Glucose From Baseline to Endpoint|Change in fasting plasma glucose from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||mmol/L||Standard Error|Least Squares Mean
1270170|NCT00359762|Secondary|Fasting Plasma Glucose at Year 3|Fasting plasma glucose at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
1270171|NCT00359762|Secondary|Change in HbA1c From Baseline to Endpoint|Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1270172|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 3|Change in HbA1c from baseline to Year 3.|Baseline, Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1270173|NCT00359762|Secondary|Change in Disposition Index From Baseline to Endpoint|Change in disposition index from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
1270190|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1270174|NCT00359762|Secondary|Disposition Index at Year 3|Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||ratio||Standard Error|Least Squares Mean
1270175|NCT00359762|Secondary|Change in DI30/DG30 Ratio From Baseline to Endpoint|Change in DI30/DG30 ratio from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
1270176|NCT00359762|Secondary|Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3|DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||ratio||Standard Error|Least Squares Mean
1270177|NCT00359762|Secondary|Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.|Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
1270178|NCT00359762|Secondary|Fasting Proinsulin/Insulin Ratio at Year 3|Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||ratio||Standard Error|Least Squares Mean
1270179|NCT00359762|Secondary|Change in HOMA-B From Baseline to Endpoint|Change in HOMA-B from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.|||ratio||Standard Error|Least Squares Mean
1270180|NCT00359762|Secondary|Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3|HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||ratio||Standard Error|Least Squares Mean
1270181|NCT00359762|Primary|Time to Treatment Failure|Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.|Baseline to end of Period II (up to 4.5 years)|ITT Efficacy Population.|||week||95% Confidence Interval|Median
1270182|NCT00359762|Primary|Number of Patients With Treatment Failure|Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.|Baseline to end of Period II (up to 4.5 years)|ITT Efficacy Population: Enrolled patients with a baseline and at least one post-baseline measurement of HbA1c in Study Period II (including only Study Period II); patients analyzed according to treatment as randomized.|||number of patients|||Number
1270183|NCT00359736|Primary|Change in 6-minute Walk Test|Distance in meters -- Distance (meters) walked in 6 minutes|0 - 6 months||||meters||Standard Deviation|Mean
1270184|NCT00359736|Secondary|Dyspnea Score (Borg Scale)|"The Dyspnea score or Borg Rating of Perceived Exertion (RPE) Scale score is a subjective rating of perceived exertion. In medicine this is used to document the patient's effort and exertion, breathlessness and fatigue during a physical test.~The Dyspnea score ranges from 0 (No breathlessness at all) to 10 (Maximum or extremely strong breathlessness).~IN this study the Specific Objective 2 was to assess and compare changes from baseline in pre- and post-exercise dyspnea in the sildenafil and placebo control groups."|0 - 6 months||||units on a scale||Standard Deviation|Mean
1270185|NCT00359632|Secondary|Percentage of Participants by Clinical Outcome of Infection at End of Study|Clinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response.|At End of Study visit||||Percentage of Participants|||Number
1270186|NCT00359632|Primary|Percentage of Participants With an Adverse Event||Through and including 28 calendar days after the last administration of the investigational product||||Percentage of Participants|||Number
1270187|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.|From Month 0 to Month 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1270188|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.|From Month 0 to Month 36|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1270191|NCT00359619|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1270192|NCT00359619|Secondary|Number of Subjects With at Least One Medically Significant Condition (MAEs).|MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1270193|NCT00359619|Secondary|Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)|NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term)|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1270194|NCT00359619|Secondary|Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1270195|NCT00359619|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||subjects|||Number
1270196|NCT00359619|Secondary|Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL.||95% Confidence Interval|Geometric Mean
1270197|NCT00359619|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||subjects|||Number
1270198|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1270199|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1270200|NCT00359619|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||subjects|||Number
1270201|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1270241|NCT00358956|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 24 weeks|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.||||Participants|||Number
1270202|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1270203|NCT00359619|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||subjects|||Number
1270204|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|360 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <330 days or >390 days post-randomization are assigned an unfavorable outcome (mRS>2).|||participants|||Number
1270205|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|270 days|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <240 days or >300 days post-randomization are assigned an unfavorable outcome (mRS>2).|||participants|||Number
1270206|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|at 180 days|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <150 days or >210 days post-randomization are assigned an unfavorable outcome (mRS>2).|||participants|||Number
1270207|NCT00359424|Secondary|Trail Making Test Part B Time|The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a “trail” made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.|at 90 days post randomization|Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part B.|||seconds||Standard Deviation|Mean
1270208|NCT00359424|Secondary|Trail Making Test Part A Time|The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a “trail” made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.|90 days post randomization|Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part A.|||seconds||Standard Deviation|Mean
1270209|NCT00359424|Secondary|Barthel Index (BI) Dichotomized 0-90 Versus 95-100|The Barthel Index (BI)is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables- feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. The lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence.|at 90 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing BI and BI measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (BI 0-90).|||participants|||Number
1270262|NCT00358735|Post-Hoc|Allogeneic Blood Transfusion Units|Allogeneic blood transfusion per patient in specific treatment Group|Up to 30 days||||Avg. Unit per patient in arm||Standard Deviation|Mean
1270210|NCT00359424|Secondary|National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.|The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit.|at 90 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (NIHSS score>1).|||participants|||Number
1270211|NCT00359424|Secondary|National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.|"The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher~>> scores indicating greater severity of deficit."|at 24 hours post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <18 hours or >30 hours post-randomization are assigned an unfavorable outcome (NIHSS score>1).|||participants|||Number
1270212|NCT00359424|Secondary|Asymptomatic Intracranial Hemorrhage|Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site.|within 30 hours post IV rt-PA|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.|||participants|||Number
1270213|NCT00359424|Secondary|Incidence of Parenchymal Type II (PH2) Hematomas|a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans.|within 30 hours post IV rt-PA|Subjects were excluded if a post-baseline CT scan was not obtained within 30 hours of randomization (i.e., participants who died, had care withdrawn at the request of the family, or underwent imaging after the 30-hour window).|||participants|||Number
1270214|NCT00359424|Primary|Symptomatic Intracranial Hemorrhage|Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site|within the first 30 hours post IV rt-PA|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.|||participants|||Number
1270215|NCT00359424|Primary|Death Due to Any Cause||within 90 days post randomization|The intent-to-treat analysis includes all subjects who were randomized, and each subject analyzed according to the treatment group to which they were randomly assigned. Subjects who ended the study prior to 90 days post- randomization for a reason other than death (LTFU etc) (n=8 in group two; n=2 in group one) are assumed to be alive|||participants|||Number
1270216|NCT00359424|Primary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|at 90 days post randomization|The primary analysis was conducted according to intention to treat. All subjects were analyzed in the treatment group to which they were randomized. Subjects with missing mRS (n=9 in group two; n=4 in group one) or mRS assessed <60 days or >120 days post-randomization (n=10 in group two; n=4 in group one) are assigned an unfavorable outcome(mRS >2)|||participants|||Number
1270217|NCT00359281|Primary|AUC0-t Nicotinuric Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270218|NCT00359281|Primary|AUC0-t Nicotinic Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270219|NCT00359281|Primary|AUC0-t Rosuvastatin (Lomitapide 60 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270220|NCT00359281|Primary|AUC0-t Atorvastatin Acid (Lomitapide 60 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270221|NCT00359281|Primary|AUC0-t Fenofibric Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270222|NCT00359281|Primary|AUC0-t Rosuvastatin (Lomitapide 10 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270223|NCT00359281|Primary|AUC0-t Total Ezetimibe|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270224|NCT00359281|Primary|AUC0-t Simvastatin Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270225|NCT00359281|Primary|AUC0-t Simvastatin|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270226|NCT00359281|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline to Day 8|Intention To Treat|||Percent Change||Standard Deviation|Mean
1270227|NCT00359281|Primary|Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)|0 to 24 hour|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
1270228|NCT00359216|Primary|Apnea-Hypopnea Index|Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.|change from baseline (screening) at the end of 28 days of treatment|Diary data over interval of days was derived using the mean of non-missing entries. No imputation was applied to any other missing data|||apnea-hypopnea episodes per hour||Standard Deviation|Mean
1270229|NCT00359203|Primary|Syncope Recurrence Rate|Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement|2 years|77 patients implanted with dual chamber pacemaker: 39 patients randomized to pacemaker OFF and 38 patients randomized to pacemaker ON|||percentage of participants||95% Confidence Interval|Number
1270230|NCT00359138|Primary|Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment|The number of days after treatment discontinuation until a measurable wheal and flare response.|Starting at Day 8||||Days||Standard Error|Mean
1270231|NCT00359073|Secondary|Sputum Eosinophil Count|Sputum was collected from both groups over 14 days after inoculation with the cold virus. Cell counts and differentials were made from sputum samples after treatment with 0.1% dithiothreitol. Eosinophils were counted and are expressed as as percentage of cells (percent of the total number counted) at the 14 day timepoint.|14 days||||percentage of eosinophils||Inter-Quartile Range|Median
1270232|NCT00359073|Secondary|Peak Viral Shedding|Viral shedding was measured in both groups. Viral titers from nasal lavage were calculated after 4 tissue culture tubes containing WI38 cells (human lung diploid cells) were inoculated for each serial 10-fold dilution of samples and incubated while rolling at 33 degrees Celsius for 10 days (measurement for analysis was taken at baseline and 7 days). Tubes were read at baseline and 7 days later. TCID50 was calculated as the concentration that was capable of infecting 50% of the tubes. Viral titers are expressed as TCID50 per milliliter. Time frame measurement was at baseline and 7 days.|Baseline and 7 days||||TCID50 per milliliter||Inter-Quartile Range|Median
1270233|NCT00359073|Primary|Mean Asthma Symptom Score|Asthma symptom scores were assessed twice per day with subjects completing a validated daytime diary card before bed and a nocturnal diary card on awakening. Subjects answered 4 questions about their asthma symptoms (0, none of the time; 6, all of the time). Daily score were calculated as the average of the 4 questions and an overall score for the week was assessed as the average of the daily scores. Time frame measurement was Day 7.|Day 7||||Asthma symptom score||Inter-Quartile Range|Median
1270234|NCT00359021|Secondary|Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)|In the table below, the total number of participants analyzed in the Duet Placebo and Duet TMC125 groups, respectively at each time point were: Baseline (256;247 participants), Week 24 (251;240 participants), Week 48 (235;192 participants), and Week 96 (123;69 participants).|Baseline, Week 24, Week 48, and Week 96|The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.|||log10 copies/mL||95% Confidence Interval|Mean
1270235|NCT00359021|Secondary|The Percentage of Participants With Virologic Outcomes Over Time|The table below shows the percentage of participants with virologic suppression (< 50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available over time (ie, at Weeks 24, 48, and 96).|Weeks 24, 48, and 96|The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.|||Percentage of Participants|||Number
1270236|NCT00359021|Primary|The Number of Participants Experiencing Adverse Events|The table below provides the number of participants who experienced Serious Adverse Events (SAEs) and Other Adverse Events (except SAEs) that started or worsened in severity during the overall TMC125-C217 treatment period. The duration of treatment ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.|1 week to 180 weeks, with a median of 62 weeks|The safety analysis was carried out on the ITT population, which included all participants who received at least one dose of investigational medication.|||Participants|||Number
1270237|NCT00358956|Secondary|Biochemical Response Carcinoembryonic Antigen CEA)|A patient’s best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for Partial Response (PR) or Complete Response (CR) were first met.|Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation||||Participants|||Number
1270238|NCT00358956|Secondary|Biochemical Response Calcitonin (CTN )|A patient’s best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met.|Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters)||||Participants|||Number
1270239|NCT00358956|Secondary|Symptomatic Response|Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level.|Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment.||||Participants|||Number
1270240|NCT00358956|Secondary|World Heath Organization (WHO) Performance Status|Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy – 5 dead) based on their physical capabilities|WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment.||||Participants|||Number
1280669|NCT00263887|Secondary|Change in Lung Density at Each Visit as Measured by Computed Tomography||24 or 30 months|||||||
1270242|NCT00358956|Secondary|Progression-Free Survival (PFS)|Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.||||Months||95% Confidence Interval|Median
1270243|NCT00358956|Primary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE."|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.||||Participants|||Number
1270244|NCT00358917|Secondary|Percentage of Participants With New Primary Protease Mutations at Week 48|Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).|Week 48 (End of Study)|All randomized participants who received at least 1 dose of study drug and had post baseline genotypic resistance assay results.|||Percentage of Participants|||Number
1270245|NCT00358917|Secondary|Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir|Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.|Week 48 (End of Study)|Dropouts-as-censored: participants were responders if they had HIV-1 RNA <50 copies/mL at Week 48. Participants who discontinued (d/c'd) while suppressed or w/o post baseline (BL) levels were excluded. Those d/c'd <Day 85 were excluded unless they had >=1 post BL level & didn't achieve a decrease >=1.0 log10 copies/mL, then they were nonresponders.|||Percentage of Participants|||Number
1270246|NCT00358917|Secondary|Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts||Week 48 (End of Study)|All randomized participants who received at least 1 dose of study drug and who had CD4+ T cell counts at both the Baseline Visit and Week 48.|||cells/microliter||Standard Error|Mean
1270247|NCT00358917|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48||Week 48 (End of Study)|Observed data analysis using all available Week 48 data from all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1270248|NCT00358917|Primary|Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.|Week 48 (End of Study)|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1270249|NCT00358826|Other Pre-specified|Change From Baseline in Percent Stenosis||Baseline and 24 weeks|Evaluable Population|||Percentage||95% Confidence Interval|Least Squares Mean
1270250|NCT00358826|Other Pre-specified|Change From Baseline in Mean Plaque Density|Plaque density is expressed in Hounsfield Units (HU)|Baseline and 24 weeks|Evaluable Population|||HU||95% Confidence Interval|Least Squares Mean
1270251|NCT00358826|Other Pre-specified|Change From Baseline in Noncalcified Plaque Volume||Baseline and 24 weeks|Evaluable Population|||mm^3||95% Confidence Interval|Least Squares Mean
1270252|NCT00358826|Other Pre-specified|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy||Baseline and 24 weeks|Evaluable Population of the MDCT substudy|||mg/L||Inter-Quartile Range|Median
1270253|NCT00358826|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study||Baseline and 12 weeks|Evaluable Population|||mg/L||Inter-Quartile Range|Median
1270254|NCT00358826|Secondary|Change From Baseline in Leukotriene E4 (LTE4)|Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate|Baseline and 12 weeks|Core Study Evaluable Population|||pg/mg Cr||95% Confidence Interval|Least Squares Mean
1270255|NCT00358826|Primary|Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood||Baseline and 12 weeks|Core Study Evaluable Population|||pg/mL||95% Confidence Interval|Least Squares Mean
1270256|NCT00358735|Secondary|In-Patients’ Compliance|"Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.~The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group).~The compliance is expressed as percentages."|Surgery till discharge||||percentage of usage time|||Number
1270257|NCT00358735|Secondary|Serious Adverse Events|"Serious Adverse Events (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening.~SAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures"|SAE data were collected Up to 3 months post-op||||events|||Number
1270258|NCT00358735|Post-Hoc|Composite Outcome of Major Bleeding + VTE|Major bleeding + DVT events + PE Events|Day of surgery and up to 3 months||||Events|||Number
1270259|NCT00358735|Post-Hoc|Changes in Hemoglobin Levels|Changes in Hemoglobin levels|After surgery untill discharge||||mean change (g/l)||Standard Deviation|Mean
1270260|NCT00358735|Post-Hoc|Bleeding Index ≥ 2|Bleeding index was defined as the number of units of whole blood or packed red blood cells transfused plus the difference between the first hemoglobin value after surgery and the value prior to discharge|Surgery till discharge||||units on a scale||Standard Deviation|Mean
1270261|NCT00358735|Post-Hoc|Autologous Blood Transfusion Units|Autologous blood transfusion per patient in specific treatment Group|Up to 30 days||||Avg. Unit per patient in arm||Standard Deviation|Mean
1270265|NCT00358735|Secondary|OutPatient Patients’ Compliance|"Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.~The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group).~The compliance is expressed as percentages."|10-12 days post-op||||percentage of usage time|||Number
1270266|NCT00358735|Secondary|Major Bleeding Complication|Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.|Up to 30 days||||Events|Participants||Number
1270267|NCT00358735|Primary|Clinical PE (Pulmonary Embolism) Events|Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT|Day of surgery and up to 3 months||||Events|Participants||Number
1270268|NCT00358735|Primary|Events of Deep Vein Thrombosis (DVT)|"10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler.~Day of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods"|10-12 days post-op; and from day of surgery and up to 3 months if symptomatic||||Events|Participants||Number
1270269|NCT00358670|Secondary|PASI 12-month AUC (Time Adjusted Total PASI Score Over the 12 Month Period)|The PASI 12-month AUC is a time adjusted total PASI score over the 12 month (360 days) period. The AUC is a continuous measurement (not a score on a scale); and a lower value is considered better. The weighted average PASI score over 12 months (using all available PASI scores during a 12 month period [from Day 0 to 360 days]) is is obtained by using PASI 12-month AUC /360 days.|Day 0 to 360 days|Participants with at least two post Study P04563 randomization PASI scores (at least one is 330 days or more from Study P04563 randomization).|||12-month PASI AUC||Standard Error|Mean
1270270|NCT00358670|Secondary|PASI 6-month Area Under the Curve (AUC); (Time Adjusted Total PASI Score Over the 6 Month Period)|The PASI 6-month AUC is a time adjusted total PASI score over the 6 month (180 days) period. The AUC is a continuous measurement (not a score on a scale); a lower value is considered better and a higher value is considered worse. The weighted average PASI score over 6 months (using all available PASI scores during a 6 month period [from Day 0 to 180 days]) is obtained by using PASI 6-month AUC /180 days.|Day 0 to 180 days|Participants with at least two post Study P04563 randomization PASI scores (at least one is 150 days or more from Study P04563 randomization).|||6-month PASI AUC||Standard Error|Mean
1270271|NCT00358670|Secondary|Number of Participants Who Achieved PASI75 Response at Week 100|PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)|100 Weeks|Descriptive summary of all randomized subjects who completed 100 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 100.|||Participants|||Number
1270272|NCT00358670|Secondary|Number of Participants Who Achieved PASI75 Response at Week 52|PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)|52 weeks|Descriptive summary of all randomized subjects who completed 52 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 52.|||Participants|||Number
1270273|NCT00358670|Primary|Number of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI75) Response at Week 128|PASI75 defined as the number of participants who achieved a >=75% improvement in Psoriasis Area and Severity Index (PASI) from the original Baseline in Study P04271 (NCT00251641).|128 weeks|Due to the early termination of the study, no subjects completed 128 weeks of therapy.||||||
1270274|NCT00358644|Primary|Complete Response = Morphologic Complete Remission (mCR)||1 year|Intent-to-Treat (ITT)|||Participants|||Number
1270275|NCT00358579|Secondary|Survival to Admission.|Survival to admission is defined as the presence of pulse on admission to hospital (discharged from Emergency Department and admitted to Intensive Care Units /wards). This measures the number of participants with pulse and who were admitted to hospital.|No specific time frame. Survival to admission refers to sustained return of spontaneous circulation until admission and transfer of care to Intensive Care Units /wards||||Participants|||Number
1270276|NCT00358579|Secondary|Return of Spontaneous Circulation.|Return of spontaneous circulation is defined as the presence of any palpable pulse detected by manual palpation of a major artery. This is measured as number of participants who had return of spontaneous circulation during resuscitation.|during resuscitation||||Participants|||Number
1270277|NCT00358579|Secondary|Neurological Status at 1 Year.|Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC): 1 and 2. CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.|at 1 year post arrest||||Participants|||Number
1270278|NCT00358579|Secondary|Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.|Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC):1 and 2.CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.|at 30 days post arrest||||Participants|||Number
1270279|NCT00358579|Primary|Survival to Hospital Discharge.|Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first.|at 30 days post arrest||||Participants|||Number
1270316|NCT00358449|Primary|Plasma Clearance (CL) of Mepolizumab|Clearance is defined as the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate plasma clearance of mepolizumab.|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34|Pharmacokinetic Population|||Liters per Day (L/day)||95% Confidence Interval|Geometric Mean
1270280|NCT00358527|Primary|Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.|"Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time.~NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate."|29 days|Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.|||Units on a scale||Standard Error|Least Squares Mean
1270281|NCT00358527|Primary|Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.|"The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12.~NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate."|Average of the last 7 days of treatment|Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.|||Units on a scale||Standard Error|Least Squares Mean
1270282|NCT00358501|Other Pre-specified|Historical Control Group Adverse Event Information|Historical Control group was not assessed for severity|Through 30 days from the last dose of Defibrotide||||Number of patients|||Number
1270283|NCT00358501|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events||Through 30 days from the last dose of Defibrotide|Safety population|||percentage of participants|||Number
1270284|NCT00358501|Secondary|Survival at Day+180 Post Hematopoietic Stem Cell Transplantation|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|180 days post hematopoietic stem cell transplant|Intent-to-Treat|||percentage of participants||95.1% Confidence Interval|Number
1270285|NCT00358501|Primary|Complete Response by Day+100 Post Hematopoietic Stem Cell Transplant|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|Day+100 post hematopoietic stem cell transplant|Intent-to-Treat|||percentage of participants||95.1% Confidence Interval|Number
1270286|NCT00358501|Primary|Survival at Day+100 Following Hematopoietic Stem Cell Transplant|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|Day+100 post hematopoietic stem cell transplant|Intent-to-Treat|||percentage of participants||95.1% Confidence Interval|Number
1270287|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of U. Parvum|In vitro susceptibilities of U. parvum|baseline|isolates|||MIC (ug/mL)||Full Range|Median
1270288|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2|In vitro susceptibilities of U. urealyticum biovar 2|baseline|isolates|||MIC (ug/mL)||Full Range|Median
1270289|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline|In vitro susceptibilities of M. genitalium to doxycycline|baseline||||MIC (ug/mL)||Full Range|Median
1270290|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin|In vitro susceptibiities of M. genitalium to azithromycin|baseline|Participants with recovered isolates that successfully underwent in vitro assessment of antibiotic susceptibilities|||Participants|||Count of Participants
1270291|NCT00358462|Secondary|Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit|Proportion of men with Ureaplasma urealyticum at the initial study visit who had clinical cure, defined as <5 PMNs/HPF (with or without urethral symptoms) on a urethral Gram stain and absence of urethral discharge at follow-up.|approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)|mITT population|||participants|||Number
1270292|NCT00358462|Secondary|Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit|Proportion of men with M. genitalium at the initial study visit who had clinical cure, defined as <5 PMNs/HPF (with or without urethral symptoms) on a urethral Gram stain and absence of urethral discharge at follow-up.|approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)|mITT population|||participants|||Number
1270293|NCT00358462|Primary|mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit|Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit|3 weeks (allowable window 2-5)|mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for U. urealyticum at baseline|||participants|||Number
1270294|NCT00358462|Primary|mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit|Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)|approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)|mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for M. genitalium at baseline|||participants|||Number
1270295|NCT00358449|Secondary|Plasma Concentration of Mepolizumab|Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 to estimate the plasma concentration of mepolizumab. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34|Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.|||Microgram per milliliter (µg/mL)||Standard Deviation|Mean
1270296|NCT00358449|Secondary|Absolute Blood Eosinophils Count at the Indicated Time Points|Blood samples were obtained at Screening, pre-infusion and 24h and 72-96h post-infusion at Day 1, Weeks 4 and 8; and at Week 2, 6, 10, 12, 16, 20, 24 and 34 visits or Early Withdrawal Visit to estimate blood eosinophil count.|Screening, Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Giga cells per liter (GI/L)||Standard Deviation|Mean
1270297|NCT00358449|Secondary|Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24|Participants underwent an EGD with biopsies at Screening and at Weeks 12 and 24. Mean esophageal eosinophils were calculated as the mean number across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 12 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Cells/HPF||Standard Error|Mean
1270298|NCT00358449|Secondary|Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24|Participants underwent an esophagogastroduodenoscopy (EGD) with biopsies at Screening and at Weeks 12 and 24. Peak esophageal eosinophils were calculated as the maximum count across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 12 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Cells/HPF||Standard Error|Mean
1270299|NCT00358449|Secondary|Number of Participants With Maintenance of Response|Participants who achieved a response of <5 esophageal eosinophils/HPF at Week 12 by worst case analysis, were evaluated for maintenance of response of <20 cells/HPF at Week 24. Response categories were defined as: non-responder (did not respond at Week 12 or Week 24); delayed responder (did not respond at Week 12 but responded at Week 24); relapsed (responded at Week 12 but not at Week 24); maintained (responded at Week 12 and Week 24). The following assumptions were made for worst case: if a Participant dropped out of the study due to lack of efficacy or an adverse event and had a missing response, their response was imputed as not achieved (i.e. failure). However for Participants withdrawn for other reasons (e.g. lost to follow-up) with a missing response (i.e. did not have the biopsy) the response was made as missing and not imputed.|Week 12 and Week 24|ITT Population. Only those participants were responders at Week 12 were analyzed.|||Participants|||Number
1270300|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years)|The percentage of days with feeling of something stuck in throat during each analysis period (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
1270301|NCT00358449|Secondary|Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only)|Par. and/or parent/guardian recorded daily symptoms of the feeling like something is stuck in throat on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom of feeling of something stuck was not experienced. On days that feeling of something stuck in the throat was experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. Average bothersome score was calculated as the sum of the respective scores for that interval divided by the number of days. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a Scale||95% Confidence Interval|Least Squares Mean
1270302|NCT00358449|Secondary|Change From Baseline in the Percentage of Days Participants Ate Solid Foods|The percentage of days with the symptom of difficulty and pain when eating solid foods during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
1270303|NCT00358449|Secondary|Change in Baseline in Pain With Eating Solid Foods Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned for that symptom when Par. did not eat. The severity of pain was assessed when Par. eats food as: 1=didn’t hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1270337|NCT00358332|Primary|Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.|The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.|7 Days following any vaccination|This outcome includes all enrolled subjects.|||Participants|||Number
1270304|NCT00358449|Secondary|Change From Baseline in Difficulty With Eating Solid Foods|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP and FP. A score of 6 was assigned for that symptom when Par. did not eat solid foods. When Par.eat solid foods, the amount of difficulty was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interactions.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1270305|NCT00358449|Secondary|Change From Baseline in Percentage of Days on Which the Participant Drank|The percentage of days with the symptom of difficulty and pain when participant drank during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
1270306|NCT00358449|Secondary|Change From Baseline in Pain With Drinking Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned the day participant did not drink. The severity of pain was assessed as: 1=didn’t hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average difficulty and pain severity scores was calculated as the sum of the respective scores for that interval divided by the number of days in the interval. . Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1270307|NCT00358449|Secondary|Change From Baseline in Daily Degree of Difficulty With Drinking|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned days the participant did not drink. The amount of difficulty with drinking was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average difficulty for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the drinking difficulty scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a Scale||95% Confidence Interval|Least Squares Mean
1270308|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Vomiting|The percentage of days with the symptom of vomiting during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
1270309|NCT00358449|Secondary|Change From Baseline in Frequency of Vomiting|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A participant vomiting any time was counted as one episode of vomiting, irrespective of how close they are to each other. The daily frequency of vomiting was calculated as the total number of times the participant vomited during the interval divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Occurrences of vomiting per day||95% Confidence Interval|Least Squares Mean
1270338|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 0|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
1270310|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores|The percentage of days with the symptom of pain in regurgitation bothersome during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
1270311|NCT00358449|Secondary|Change From Baseline in Regurgitation Bothersome Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom regurgitation was not experienced. The days regurgitation experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for Baseline score, treatment group, age group interactions|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1270312|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Pain in Chest/Throat|The percentage of days with the symptom of pain in chest/throat during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
1270313|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Pain in Stomach|The percentage of days with the symptom of pain in stomach during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
1270314|NCT00358449|Secondary|Change From Baseline in Pain in Chest/Throat Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in chest/throat was not experienced. If pain in chest/throat was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1270315|NCT00358449|Secondary|Change From Baseline in Pain in Stomach Severity Scores|Par.and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in stomach was not experienced. If pain in stomach was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric Analysis of Covariance (ANCOVA) models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The observed case (OC) datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1270410|NCT00357903|Secondary|Standardized Incidence Rate for All SEER Cancers|Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.|up to 10 years|All participants who received at least one dose of etanercept|||Observed count / expected count|||Number
1270317|NCT00358449|Primary|Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Central volume of distribution is a hypothetical volume into which a drug initially distributes upon administration. Peripheral volume of distribution is the sum of all tissue spaces outside the central compartment. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate central (V1) and periperial (V2) and Steady State (Vss) volume of distribution of mepolizumab.|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34|Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.|||Liters||95% Confidence Interval|Geometric Mean
1270318|NCT00358449|Primary|Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12|A responder was defined as a participant achieving a reduction in esophageal eosinophils to <5 cells per HPF as the highest count of eosinophils per HPF in all the esophageal sites biopsied at Week 12, confirmed by biopsy at Week 12 or at an early withdrawal visit prior to Week 12. A worst case (WC) approach was considered, if a particiapant withdrew prematurely : If a particiapnt dropped out of the study without having a biopsy taken, due to lack of efficacy or an adverse event, their response was imputed as not achieved. Participants who withdrew, without a biopsy, for other reasons (e.g. lost to follow-up) were considered non-evaluable for the primary analysis. For participants who withdrew early from the study and had a biopsy, the biopsy was used to determine their response.|Week 12|ITT Population-WC|||Participants|||Number
1270319|NCT00358449|Primary|Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit.|Blood samples for testing anti-mepolizumab antibodies were collected on Day 1, Week 4 and 8 Infusion Visit (before the IV infusion) and at Week 12, 24 and 34 Week follow-up visits. The presence of anti-human mepolizumab antibodies was assessed using an immunoelectrochemiluminescent (ECL) assay. To address transient positive results, an assessment of repeated results were made. For any visit category: results were considered as positive if it was positive at any visit during the study, and results were considered as negative if it were negative at all visits during the study. For repeat visit category: results were considered as postive if the result was positive at >1 visit, and results were considered as negative if the result was negative at all visits or was positive at only one visit.|Day 1, Weeks 4, 8, 12, 24, and 34|ITT Population|||Participants|||Number
1270320|NCT00358449|Primary|Change From Baseline in Temperature at the Indicated Time Points|Temperature measurements were obtained at the following time points: Screening, Day 1, and Weeks 4, 8, 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Degree Celsius (°C)||Standard Deviation|Mean
1270321|NCT00358449|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate measurements were obtained at the following time points: Screening, pre-infusion, 10m, 30m, 1h, 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Beats per minutes||Standard Deviation|Mean
1270322|NCT00358449|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP measurements were obtained at the following time points: screening, pre-infusion, 10 minutes (m), 30m, 1 hour (h), 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1270323|NCT00358449|Primary|Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline|12-lead ECG assessments were obtained at the following time points: screening, and Weeks 4, 8 and 12.. Overall ECG findings were summarized using the worst case findings without regard to visits ie. “any time post Baseline”. Change from Baseline in ECG findings were categorized as clinically significant change from Baseline; no clinically significant change from Baseline and not applicable.|Screening, Weeks 4, 8 and 12|ITT Population|||Participants|||Number
1270324|NCT00358449|Primary|Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period.|Blood samples were collected pre-infusion at Day 1, Week 4 and Week 8; and 24h and 72h post-infusion at Day 1, Week 4 and Week 8 time points and at Weeks 2, 6, 10, 12, 16, 20, 24, and 34 to estimate the following hematology parameters: basophils (Bas), percentage of basophils (% Bas), lymphocytes (Lym), percentage of Lym (% Lym), monocytes (Mon), percentage of Mon (% Mon), platelet count (PC), total neutrophils (TN), percentage of TN (% TN), white blood cell count (WBC), hematocrit (He), hemoglobin (Hg), and red blood cell count (RBC). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34)|ITT Population. Only those participants available at specified time points are analyzed.|||Participants|||Number
1270339|NCT00358332|Primary|Number of Subjects Spontaneously Reporting Any Serious Adverse Event.|Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.|1 year after the last vaccination.|This outcome includes all enrolled subjects.|||Participants|||Number
1280687|NCT00263666|Secondary|Geometric Mean Concentration for Anti-PRP Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1270325|NCT00358449|Primary|Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period.|Blood samples were collected at Day 1, Weeks 4, 8, 12, 16, 20 and 24 to estimate the following biochemistry parameters: alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (Ab), total protein (ToP), creatinine (Cr), total bilirubin (TB), calcium (Ca), bicarbonate (Bi), chloride (Cl), glucose (Glu), potassium (Pot), and sodium (Sod). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Participants|||Number
1270326|NCT00358449|Primary|Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is defined as any untoward medical occurrence that, at any dose that Results in death, life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; a congenital anomaly/birth defect. Drug-related AE’s were considered to have a reasonable possibility of being related to treatment by the investigator. AE, SAE and drug-related AEs are summarized by TP and FP.|From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)|Intention-to-Treat (ITT) Population: all participants who gave informed consent, were randomized and received at least one dose of medication.|||Participants|||Number
1270327|NCT00358436|Primary|Trough FEV1 (L) at 12 Weeks on Treatment|Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks|12 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Liters||Standard Error|Least Squares Mean
1270328|NCT00358436|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment|Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Percentage of Patients|||Number
1270329|NCT00358436|Secondary|Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment|Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Days||95% Confidence Interval|Median
1270330|NCT00358436|Primary|Trough FEV1 (L) at 28 Weeks on Treatment|Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks|28 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Liters||Standard Error|Least Squares Mean
1270331|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 364 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point is available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
1270332|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 272 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
1270333|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 180 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
1270334|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 90 +/- 10 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
1270335|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 60 +/- 7 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
1270336|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 30 +/- 7 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
1270749|NCT00355199|Secondary|Complete Remission|Clinical response was assessed by complete restaging according to Cheson criteria. Cheson BD, Pfistner B, Juweid ME, et al: Revised response criteria for malignant lymphoma. J Clin Oncol 25:579-86, 2007|Through therapy completion an average of 8 months||||participants|||Number
1270340|NCT00358332|Primary|Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.|The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.|Day of vaccination and 30 subsequent days.|This outcome includes all enrolled subjects.|||Participants|||Number
1270341|NCT00358332|Primary|Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.|The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.|7 Days following any vaccination|This outcome includes all enrolled subjects.|||Participants|||Number
1270342|NCT00358215|Secondary|Change From Baseline to Month 6 in KCCQ Symptom Frequency Score|The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|Baseline and Month 6|Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.|||units on a scale||Standard Error|Least Squares Mean
1270343|NCT00358215|Secondary|Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|Baseline and Month 6|Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.|||units on a scale||Standard Error|Least Squares Mean
1270344|NCT00358215|Secondary|Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure|Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat|||days||Inter-Quartile Range|Median
1270345|NCT00358215|Secondary|Time to Death From Any Cause|Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat|||days||Inter-Quartile Range|Median
1270346|NCT00358215|Primary|Time to All Cause Death or First Hospitalization for Worsening Heart Failure|Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat (ITT) analysis set, defined as all randomized participants|||days||Inter-Quartile Range|Median
1270347|NCT00358150|Secondary|Lumbar Spine and Femur Z-Scores for BMD at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Images of the lumbar spine and femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||Z-Score||Standard Deviation|Mean
1270348|NCT00358150|Secondary|Lumbar Spine and Femur T-Scores for Bone Mineral Density (BMD) at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Images of the lumbar spine and femur were obtained by dual energy X-ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-scores compares participant's bone density with that of healthy young participant of same gender. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||T-Score||Standard Deviation|Mean
1270349|NCT00358150|Secondary|Bone Marrow Infiltration: Number of Participants With Improvement From Baseline in Dark Marrow at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and at End of Study (EOS)|Bone marrow infiltration assessments were designed to evaluate improvements in dark marrow using MRI. Each MRI assessment was performed for both femurs and consisted of reviewing 6 different zones (the femoral head, greater trochanter, intertrochanteric region, shaft, distal metaphysis, and condyles). MRI images recorded dark marrow for each zone as either present or not present at baseline. In this outcome, number of participants (for whom dark marrow was present at baseline) with improvement from baseline in dark marrow at each specified time point were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ’n’ signifies number of participants who were presented with dark marrow at baseline and had data available at specified time points.|||Participants|||Count of Participants
1270350|NCT00358150|Secondary|Number of Participants With No Bone Crisis at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Bone crisis was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crisis, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, and 2= 2 bone crises during the assessment period. In this outcome, number of participants with 0= no bone crises levels at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||participants|||Number
1270351|NCT00358150|Secondary|Number of Participants With Mobility Status (MS) at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Mobillity, i.e. ability to walk was assessed as a part of Gaucher disease assessment in participants.In this outcome, number of participants with their different mobility status (unrestricted mobility, walks with difficulty) at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||participants|||Number
1270352|NCT00358150|Secondary|Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain and moderate bone pain. In this outcome, number of participants with different levels of bone pain at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||participants|||Number
1270353|NCT00358150|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Scores at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|The FSS is an instrument consisting of 9 self-administered questions that measures the impact of severity of fatigue symptoms on everyday functioning, based on the recall over the past week. Score range for each question ranges from 1 (minimum) to 7 (maximum), where higher score indicates greater severity. FSS total score was calculated by averaging the results of all questions. Total FSS score ranges from 9 (minimum) to 63 (maximum), where higher scores indicates greater severity.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.|||units on a scale||Standard Deviation|Mean
1270354|NCT00358150|Secondary|Change From Baseline in 36-Item Short Form (SF-36) Health Survey Scores at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and Year 9 at End of Study|The SF-36 questionnaire, version 2, investigates the participant’s health-related quality of life (HRQL). It is a 36-item questionnaire measuring 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting best health-related quality of life. Two summary scale scores were computed from the 8 domain scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranges from 0 (worst) to 100 (best), with higher scores reflecting best health-related quality of life.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.|||units on a scale||Standard Deviation|Mean
1270355|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Chitotriosidase) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
1270356|NCT00358150|Secondary|Percent Change From Baseline in Biomarker Chemokine Ligand 18 (CCL18) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
1270357|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Tartrate-Resistant Acid Phosphatase [TRAP]) Level at Year 1 and Year 2||Baseline, Year 1, Year 2|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points. As per the change in planned analysis, TRAP was not assessed after Year 2.|||percent change||Standard Deviation|Mean
1270358|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Angiotensin Converting Enzyme) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time point.|||percent change||Standard Deviation|Mean
1270443|NCT00357656|Secondary|Incidence of Factor VIII Inhibitory Antibody (≥0.4 Bethesda Units Using the Nijmegen Modification of the Bethesda Assay Formation)|Number of participants that developed Factor VIII inhibitory antibody during the study.|Throughout the study period of approximately 9-26 weeks per participant|Participants in the Safety Analysis Set treated with at least one ADVATE infusion.|||Participants|||Number
1270359|NCT00358150|Secondary|Percent Change From Baseline in Platelet Count at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in platelet count = ([platelet count at specified time points minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
1270360|NCT00358150|Secondary|Absolute Change From Baseline in Hemoglobin at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Absolute change = hemoglobin level at specified time points minus hemoglobin level at baseline.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||g/dL||Standard Deviation|Mean
1270361|NCT00358150|Secondary|Percent Change From Baseline in Liver Volume at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in liver volume = ([liver volume at specified time points minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
1270362|NCT00358150|Secondary|Percent Change From Baseline in Spleen Volume at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in spleen volume = ([spleen volume at specified time points minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
1270363|NCT00358150|Primary|Percentage of Participants Demonstrating A Meaningful Clinical Response|A meaningful clinical response was defined as an improvement in at least 2 of the 3 main efficacy parameters: a) an increase in hemoglobin of greater than or equal to (>=) 0.5 gram/deciliter from baseline, b) an increase in platelets of >=15 percent (%) from baseline, c) reduction in total spleen volume of >= 15% from baseline. As hemoglobin, platelets, total spleen volume were abnormal at baseline, within each participant, only those parameters were used in the evaluation of meaningful clinical response which were abnormal at baseline.|Baseline, Year 1|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat.|||percentage of participants|||Number
1270364|NCT00358007|Primary|Average Residual Error Motion of Patients Undergoing Radiotherapy|To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms|Daily after each radiotherapy treatment||||millimeters||Standard Deviation|Mean
1270365|NCT00358007|Primary|Average Interfraction Shift of Patients Undergoing Radiotherapy|"Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan.~Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken."|Daily prior to radiation||||millimeters||Standard Deviation|Mean
1270366|NCT00357994|Secondary|Employment Impairment (EMP) II Status at Week 12|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.|Week 12 (or early termination)|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.|||participants|||Number
1270367|NCT00357994|Secondary|Employment Impairment (EMP) I Status at Baseline|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).|Baseline|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.|||participants|||Number
1270368|NCT00357994|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0–100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270369|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270455|NCT00357552|Secondary|Percentage of Subjects Reporting Not Skipping Medications in the Last Month.|The percentage of subjects reporting never missing medications in the last month.|Study entry and weeks 2, 4, 8, 12, 16, 20, and 24|All participants enrolled.|||percentage of subjects with data|||Number
1270370|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV were totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.|||units on a scale||Standard Error|Least Squares Mean
1270371|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0–4) or a 2-point scale (0 or 1). The Part IV score ranges from 0–23 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270372|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.|||units on a scale||Standard Error|Least Squares Mean
1270373|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270374|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270375|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270376|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270377|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270481|NCT00357110|Primary|Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)|Number of patients event-free|12 month period following randomisation||||Participants|||Number
1270378|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270379|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270380|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270381|NCT00357994|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270382|NCT00357994|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270383|NCT00357994|Secondary|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270384|NCT00357994|Secondary|Change From Baseline in UPDRS Part III Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270385|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270407|NCT00357968|Primary|Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose|IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100.|6 hours after loading dose|"Consists of all patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist, and had evaluable pre-treatment and 6 hour MPA measurements.~Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing."|||percent inhibition||Standard Deviation|Mean
1270386|NCT00357994|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1270387|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1270388|NCT00357994|Secondary|"Change From Baseline in Average Daily Normalized On Time Without Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Error|Least Squares Mean
1270389|NCT00357994|Primary|"Change From Baseline to Week 12 in Average Daily Normalized Off Time"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Error|Least Squares Mean
1270390|NCT00357968|Secondary|Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose|Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.|||ng/ml||Standard Deviation|Mean
1270391|NCT00357968|Secondary|Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose|Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis.|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.|||ng/ml||Standard Deviation|Mean
1270392|NCT00357968|Secondary|Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose|Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.|||IU/L||Standard Deviation|Median
1270393|NCT00357968|Secondary|Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose|Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.|||IU/L||Standard Deviation|Mean
1270394|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|after 14 days of maintenance dosing|Includes patients who received a loading dose and PCI, regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)|||percent (%) platelet reactivity index||Standard Deviation|Mean
1270395|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean flourescence index. A lower PRI indicates greater antiplatelet effect.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements.|||percent (%) platelet reactivity index||Standard Deviation|Mean
1270408|NCT00357955|Primary|Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg|The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L).|4 months||||percentage|||Number
1270396|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, and had evaluable VASP measurements, and did not receive a GP IIb/IIIa antagonist. Patients had received a single loading dose but had not yet received any maintenance treatment.|||percent (%) platelet reactivity index||Standard Deviation|Mean
1270397|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|2 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements. Patients had received a single loading dose but had not yet received any maintenance treatment.|||percent (%) platelet reactivity index||Standard Deviation|Mean
1270398|NCT00357968|Secondary|Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|14 days after cross-over|Includes patients who received a single loading dose and had evaluable MPA measures,regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients received 14 days of maintenance treatment and then crossed-over to the alternate maintenance treatment for 14 days.|||participants|||Number
1270399|NCT00357968|Secondary|Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|From loading dose to day 15|Includes patients who received a single loading dose and had evaluable MPA measures, regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients had received 14 days of maintenance treatment but had not crossed-over to the alternate maintenance treatment.|||participants|||Number
1270400|NCT00357968|Secondary|Number of Hyporesponsive Participants at 6 Hours After the Loading Dose|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|6 hours after loading dose|"Includes patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist and had evaluable pre-treatment, and 6 hour MPA measurements.~Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing."|||participants|||Number
1270401|NCT00357968|Secondary|Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase|Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization|14 days after cross-over|Includes all patients who received a loading dose and underwent PCI, received a maintenance dose for 14 days, and then crossed-over to the alternate therapy for an additional 14 days of maintenance dosing.|||participants|||Number
1270402|NCT00357968|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase|Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization|after 14 days of treatment (before cross-over)|Includes all patients who received a loading dose. Patients who underwent PCI also received 14 days of maintenance treatment. Patients had not yet crossed-over to the alternate maintenance treatment.|||participants|||Number
1270403|NCT00357968|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase|"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.~Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL."|14 days after cross-over|All patients who received a loading dose of study drug, received maintenance therapy for 14 days and then switched to the alternate maintenance therapy.|||participants|||Number
1270404|NCT00357968|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase|"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.~Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL."|after 14 days of treatment (before cross-over)|Patients received a single loading dose and 14 days of maintenance therapy. Patients had not yet crossed-over to the alternate maintenance dose.|||participants|||Number
1270405|NCT00357968|Secondary|Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose|IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100.|2 hours after loading dose|Includes all patients who received a loading dose of study drug, did not receive a GP IIb/IIIa antagonist and had evaluable pretreatment and 2 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing.|||percent inhibition||Standard Deviation|Mean
1270406|NCT00357968|Primary|Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment|"Measures IPA during maintenance dosing before and after cross-over for each therapy.~IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100."|after 14 days of maintenance dosing|Includes patients who received a loading dose and underwent percutaneous coronary intervention (PCI) regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)|||percent inhibition||Standard Deviation|Mean
1270409|NCT00357903|Primary|Total Exposure Adjusted Rate of Serious Adverse Events|Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)|Up to 10 years|All participants who received at least one dose of etanercept|||Events per 100 participant-years|||Number
1270411|NCT00357903|Secondary|JRA DOI 30 at Month 3 in Juveniles|Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items.|Baseline and month 3|All participants who received at least one dose of etanercept and were evaluable for this endpoint at 3 months|||Participants|||Number
1270412|NCT00357903|Secondary|ACR20 at Month 3 in Adults|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 3|All participants who received at least one dose of etanercept and had available data at both baseline and month 3|||Participants|||Number
1270413|NCT00357903|Secondary|C-Reactive Protein|C-reactive protein at month 12|Month 12|All participants who received at least one dose of etanercept and had available data|||mg/dL||Standard Deviation|Mean
1270414|NCT00357903|Secondary|Childhood Health Assessment Questionnaire|Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).|Month 12|All participants who received at least one dose of etanercept and had available data|||Units on a scale||Standard Deviation|Mean
1270415|NCT00357903|Secondary|Health Assessment Questionnaire Disability Index|Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).|Month 12|All participants who received at least one dose of etanercept and had available data|||Units on a scale||Standard Deviation|Mean
1270416|NCT00357903|Secondary|Swollen Joint Count|Number of swollen joints|Month 12|All participants who received at least one dose of etanercept and had available data|||Joints||Standard Deviation|Mean
1270417|NCT00357903|Secondary|Tender Joint Count|Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation|Month 12|All participants who received at least one dose of etanercept and had available data|||Joints||Standard Deviation|Mean
1270418|NCT00357903|Primary|Death|Occurrence of death on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Participants|||Number
1270419|NCT00357903|Primary|Serious Infectious Event|Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.|Up to 10 years|All participants who received at least one dose of etanercept|||Participants|||Number
1270420|NCT00357903|Primary|Lymphoma|Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Participants|||Number
1270421|NCT00357903|Primary|Malignancy|Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Participants|||Number
1270422|NCT00357903|Primary|Total Exposure Adjusted Rate of Lymphomas|Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Lymphomas per 100 participant-years|||Number
1270423|NCT00357903|Primary|Total Exposure Adjusted Rate of Serious Infectious Events|Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Events per 100 participant-years|||Number
1270424|NCT00357903|Primary|Total Exposure Adjusted Rate of Deaths|Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Deaths per 100 participant-years|||Number
1270425|NCT00357903|Primary|Total Exposure Adjusted Rate of Malignancies|Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Malignancies per 100 participant-years|||Number
1270426|NCT00357903|Secondary|Dosing Period|Duration of etanercept dosing|Up to 10 years|All participants who received at least one dose of etanercept|||Days||Standard Deviation|Mean
1270427|NCT00357903|Primary|Total Exposure to Etanercept With Gaps|Total participant exposure to etanercept (Enbrel) with gaps|Up to 10 years|All participants who received at least one dose of etanercept|||Participant-years|||Number
1270428|NCT00357877|Secondary|Cumulative Crude D12FS Caries Increment|This is computed analogous to the cumulative net D12FS increment, but ignoring reversals by assigning them weights of zero.|Visit 1, 7-month follow-up, 13-month follow-up|Intention-to-Treat sample|||caries increment units/13 months||Standard Error|Mean
1270429|NCT00357877|Secondary|Total Crude D12FS Caries Increment|Computed analogous to the total net D12FS caries increment, but ignoring reversals (essentially assigned them zero weight). Computed only using baseline to 13-month visit data.|V1-13-month follow-up|Intention-to-Treat sample|||caries increment units/13 months||Standard Error|Mean
1270430|NCT00357877|Secondary|Cumulative Net D12FS Caries Increment|This measure was computed similar to the total net D12FS increment, but separately scored and combined transitions from the baseline to 7-month visits and from the 7- to 13-month visits, rather than simply looking at the baseline to 13-month visits.|Visit 1, 7-month follow-up, 13-month follow-up|Intention-to-Treat sample|||caries increment units/13 months||Standard Error|Mean
1270442|NCT00357734|Secondary|Progression-free Survival (PFS)|Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From randomization until progression or death (up to 120 months)||||Months||95% Confidence Interval|Median
1270502|NCT00357032|Secondary|Toxicity Summary|Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 and above toxicities possibly, probably or definitely related to treatment.|Up to 1 year||||participants|||Number
1270431|NCT00357877|Primary|Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))|"Study duration was too short to have progression from D2 (cavitated lesions) to D3 (cavitated lesions that involved dentin). D2 and D3 were treated equivalently for analysis.~This measure is computed as the sum of weighted counts of transitions in tooth surface status (root and coronal surfaces combined) from randomization to the 13-month follow-up visit. Disease progression had a positive weight (e.g., S-to-D1 (sound to non-cavitated lesion) or D1-to-D2 (non-cavitated to cavitated lesion) = 1, S-to-D2 (sound to cavitated lesion)= 2). Reversal had a negative weight (e.g., D1-to-S = −1). No change, transitions to or from missing or unscorable, and impossible transitions had 0 weight. Incident fillings and crowns were treated the same as incident D2 lesions for purposes of scoring. More details of the transition weights may be found at Vollmer WM et al. (2010). Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a"|(V1) to the 13 month follow-up visit|Intention to treat (ITT) sample. Multiple imputation with 8 datasets imputed via Markov Chain Monte Carlo sampling was used to handle missing data.|||weighted increment units/13 months||Standard Error|Mean
1270432|NCT00357760|Other Pre-specified|Angiogenesis-related Protein Expression||Assessed every 8 weeks during treatment and end of treatment|||||||
1270433|NCT00357760|Other Pre-specified|Circulating Levels of VEGF-Trap Complex||Assessed at baseline, 4 weeks, 6 weeks, 8 weeks and end of treatment|||||||
1270434|NCT00357760|Secondary|Progression-free Survival (PFS) Among Patients Who Undergo Dose Escalation Following Progression on Lower-dose VEGF Trap|"Patients who progressed on the 1 mg/kg dose (Arm B) at 8 weeks would have the opportunity to receive the 4 mg/kg dose. PFS is defined as the time from dose escalation to disease progression or death, whichever occurs first.~Disease progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions."|Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollment|Only patients who progressed on the low dose (Arm B) and underwent dose escalation were included in this analysis.|||weeks||90% Confidence Interval|Median
1270435|NCT00357760|Secondary|Proportion of Patients With Objective Response|"Objective response is defined as complete response (CR) or partial response (PR) determined by Solid Tumor Response Criteria (RECIST).~CR: The disappearance of all target lesions without the appearance of new lesion(s) and/or unequivocal progression of existing non-target lesions.~PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter without the appearance of new lesion(s) and/or unequivocal progression of existing non-target lesions.~To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met."|Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollment|Eligible and treated patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
1270436|NCT00357760|Primary|Proportion of Patients Alive and Progression-free at 8 Weeks|"Progression-free survival (PFS) was defined as time from randomization to the earlier of documentation of progression or death. The proportion of patients who are progression-free and alive at 8 weeks was estimated using the Kaplan-Meier method and the confidence interval was estimated using log transformation method.~Progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions."|Assessed at 8 weeks|Eligible and treated patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
1270437|NCT00357734|Primary|Number of Other Adverse Events (AEs) Related to ZD1839|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)||||number of other AEs related to ZD1839|||Number
1270438|NCT00357734|Primary|Number of Other Adverse Events (AEs)|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)||||number of other AEs|||Number
1270439|NCT00357734|Primary|Number of Serious Adverse Events (SAEs) Related to ZD1839|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)||||Number of SAEs related to ZD1839|||Number
1270440|NCT00357734|Primary|Number of Serious Adverse Events (SAEs)|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)||||number of SAEs|||Number
1270441|NCT00357734|Secondary|Overall Survival (OS)||From randomization until death (up to 120 months)||||Months||95% Confidence Interval|Median
1270444|NCT00357656|Secondary|Number of Adverse Events Related to the Administration of the Study Product.|All AEs from the first study drug exposure until the study completion/discontinuation date were to be recorded. Each AE was to be evaluated by the investigator for causal relationship (i.e., unrelated, possibly related or probably related) to the study product.|From first study drug exposure until study completion/discontinuation (approximately 9-26 weeks per subject)|Participants in the Safety Analysis Set treated with at least one ADVATE infusion.|||Adverse Events|||Number
1270445|NCT00357656|Secondary|Number of Units of Packed Red Blood Cells Transfused||During the first postoperative 24 hours|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||PRBC Units||Standard Deviation|Mean
1270446|NCT00357656|Secondary|Number of Bleeding Episodes During Treatment With Continuous or Bolus Infusion|To simplify the results below: Bleeding episodes were reported for 4 subjects (3 subjects on bolus infusion: 2 in Stratum A and 1 in Stratum B, and 1 subject on continuous infusion/Stratum B). The 4 subjects had 1 bleeding episode each. No bleeding episodes were reported for Stratum C.|Through Postoperative Day 7|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||Bleeding Episodes||Standard Deviation|Mean
1270447|NCT00357656|Secondary|Actual Postoperative Blood Loss Compared to the Expected Average Blood Loss Until Drain Removal as Predicted Preoperatively by the Surgeon|"The total blood loss for the postoperative period (from end of surgery until drain removal) was adjusted for the expected blood loss by applying a log-transformation of the blood loss data.~The drainage volume was measured every 8 hours +/- 30 minutes during the first 24 hours. If the drainage continued beyond 24 hours, the PRBC volume and hemoglobin was to be measured cumulatively every 24 hours or whenever the drainage bottle was emptied and at the time of drain removal. Prior to surgery, the operating surgeon was to predict the estimated duration of surgery and the volume (mL) of the estimated expected blood loss for the surgery in a hemostatically normal individual of the same sex, age, and stature as the study subject for the first 24 hours postoperatively, and for the postoperative period until drain removal, if drainage continued beyond 24 hours.~Units: Milliliter of blood"|From end of surgery (application of compressive dressing and release of tourniquet, if applicable) until drain removal (up to postoperative day 7).|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||Milliliter||Standard Deviation|Mean
1270448|NCT00357656|Secondary|Actual Postoperative Blood Loss During the First 24 Hours Compared With the Average Blood Loss as Predicted Preoperatively by the Operating Surgeon|"Drainage fluid volume was to be measured cumulatively and recorded every 8 hours ± 30 minutes during the first 24 hours following surgery. Prior to surgery, the operating surgeon was to predict the estimated duration of surgery and the volume (mL) of the estimated expected blood loss for the surgery in a hemostatically normal individual of the same sex, age, and stature as the study subject 1) for the intraoperative procedure (defined as the time period from incision to application of compressive dressing and release of tourniquet, if applicable), 2) for the first 24 hours postoperatively, and 3) for the postoperative period until drain removal, if drainage continued beyond 24 hours.~Units: Milliliter of blood"|During the first 24 postoperative hours blood loss was measured every 8 hours ± 30 minutes|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||Milliliter||Standard Deviation|Mean
1270449|NCT00357656|Primary|Cumulative Packed Red Blood Cell (PRBC) Volume in the Drainage Fluid During the First 24 Hours Following Surgery in Subjects Receiving ADVATE (rAHF-PFM) by Bolus (BI) or Continuous Infusion (CI)|"Drainage fluid volume was to be measured cumulatively and recorded every 8 hours ± 30 minutes during the first 24 hours following surgery.~Unit of measure: Tera per Liter is the PRBC concentration in 10^12 units per 1 liter of drainage fluid."|During the first postoperative 24 hours every 8 hours ± 30 minutes the drainage fluid was to be recorded..|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||Tera per Liter||Standard Deviation|Mean
1270450|NCT00357552|Secondary|Change in CD4+ Cell Counts From Study Entry to Week 104||Study entry and week 104|All participants enrolled.|||cells/mm^3||Inter-Quartile Range|Median
1270451|NCT00357552|Secondary|Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104||At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104|All participants enrolled.|||proportion of participants|||Number
1270452|NCT00357552|Secondary|HIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma|HIV-1 viral sequencing as ascertained from paired DBS and plasma|At study entry and virologic failure|HIV-1 viral sequence testing in DBS was not performed||||||
1270453|NCT00357552|Secondary|Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma|Proportion of DBS samples with HIV-1 RNA level <= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level <= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both <= 400 copies/mL or both > 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature).|At study entry and weeks 24 and 48|Participants with DBS samples available at study entry, week 24 or 48, with corresponding plasma HIV-1 RNA levels.|||proportion of samples|paired DBS and plasma samples||Number
1270454|NCT00357552|Secondary|Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification|25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From LPV/r intensification to week 104|All participants enrolled.|||weeks||95% Confidence Interval|Number
1270519|NCT00356863|Other Pre-specified|Blood Pressure|The pooled mean of 3 blood pressure measurements taken during the interview|1 year follow up||||mm Hg||95% Confidence Interval|Mean
1270456|NCT00357552|Secondary|Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.|Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm.|At time of virologic failure|16 subjects met the criteria for endpoint failure; 15 subjects were virologic failures and 1 subject intensified prior to virologic failure. Of the 15 subjects with virologic failure, 11 had sequence data, and sequencing failed for 4.|||participants|||Number
1270457|NCT00357552|Secondary|Number of Participants With Study-targeted Diagnoses and Clinical Events|Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair.|Study entry to week 104|All participants enrolled.|||participants|||Number
1270458|NCT00357552|Secondary|Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.|25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 >= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA >= 400 copies/mL after week 16 following suppression on LPV/r monotherapy.|Study entry to Week 104|All participants enrolled.|||weeks||95% Confidence Interval|Number
1270459|NCT00357552|Secondary|Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.|Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm.|Screening|All screened individuals.|||number of screened subjects|||Number
1270460|NCT00357552|Primary|Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.|Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From study entry to week 24|All enrolled individuals.|||cumulative probability of grade 3 or 4||95% Confidence Interval|Number
1270461|NCT00357552|Primary|Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy|Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to < 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA >= 400 copies/mL after confirmed HIV-1 RNA < 400 copies/mL.|From study entry to week 24|All enrolled individuals.|||percentage of enrolled subjects||90% Confidence Interval|Number
1270462|NCT00357500|Secondary|Best Response|As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.||||participants|||Number
1270463|NCT00357500|Secondary|27-Week Overall Survival|27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods.|Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.|The analysis dataset is comprised of all treated patients.|||Probability||95% Confidence Interval|Number
1270464|NCT00357500|Secondary|27-Week Progression-Free Survival|27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.|The analysis dataset is comprised of all treated patients.|||Probability||95% Confidence Interval|Number
1270465|NCT00357500|Primary|Therapy Completion Rate|Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|27 weeks|The analysis dataset is comprised of all treated patients.|||proportion of patients||90% Confidence Interval|Number
1270466|NCT00357396|Primary|Overall Objective Response||2 years||||participants|||Number
1270467|NCT00357370|Secondary|Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2|Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing TDDI values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||units/day||Standard Error|Mean
1271047|NCT00352053|Secondary|Change From Baseline to Week 48 in HIV-1 RNA||Baseline to 48 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||log10 copies/mL||Inter-Quartile Range|Median
1270468|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c decrease from baseline >= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||Participants|||Number
1270469|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c <=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||Participants|||Number
1270470|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||Participants|||Number
1270471|NCT00357370|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing FPG values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||mg/dL||Standard Error|Mean
1270472|NCT00357370|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||% of hemoglobin||Standard Error|Mean
1270473|NCT00357331|Primary|P1NP (Amino-terminal Propeptide of Type I Procollagen)|One measure of bone turnover was P1NP as a morning lab draw.|Baseline,1,3,6,12 months|The numbers analyzed reflect the number of participants evaluable at each time point.|||micrograms/L||Standard Deviation|Mean
1270474|NCT00357331|Secondary|Number of Participants With Stable Bone Mineral Density (BMD) Over 12 Months at All Sites.|BMD was performed at lumbar spine, total hip and femoral neck using dual-energy X-ray Absorptiometry (DXA) Hologic; Bedford, Massachusetts.|1 year||||Participants|||Count of Participants
1270475|NCT00357331|Primary|Urinary-N-telopeptide|One measure of bone turnover was urinary-NTX as a second void morning urine.|Baseline,1,3,6,12 months|The numbers analyzed reflect the number of participants evaluable at each time point.|||nml BCE/nmol creatinine||Standard Deviation|Mean
1270476|NCT00357162|Secondary|Toxicity of Belinostat in Patients With Myelodysplastic Syndrome|Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Reporting events deemed at least possibly related to study treatment.|Prior to each course (every 21 days), and every 3 months for up to 3 years after completion of study treatment||||participants|||Number
1270477|NCT00357162|Secondary|Duration of Response|Estimated using the method of Kaplan-Meier.|From the date of documented response until the date of progression or last follow-up, assessed up to 3 years|One participant had a confirmed Hematologica Improvement. For patient confidentiality, we are not reporting response data.||||||
1270478|NCT00357162|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|From date of registration to the date of last follow-up or death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
1270479|NCT00357162|Secondary|Time to Progression|Estimated using the method of Kaplan-Meier.|Time from registration to the date of progression or last follow-up, assessed up to 3 years||||months||95% Confidence Interval|Median
1270480|NCT00357162|Primary|Number of Confirmed Responses (Complete Response, Partial Response, or Hematologic Improvement) Noted on 2 Consecutive Evaluations at Least 4 Weeks Apart|"Complete Response (CR)~A CR is defined as a participant with bone marrow showing less than 5% myeloblasts with no evidence of dysplasia and with adequate peripheral blood counts for at least 2 months (hemoglobin > 11 g/dl, neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3) and with no blasts in the peripheral.~Partial Response (PR)~All the CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment, or a less advanced WHO classification than pretreatment.~Hematologic Improvement (HI)~A 2g/dl increase in hemoglobin for participants with <11g/dl hemoglobin at pretreatment, or an increase of >30,000/mm^3 platelets for participants with <100,000/mm^3 at pretreatment, or a 100% increase in neutrophil counts for participants with <1500/mm^3 at pretreatment"|12 weeks||||participants|||Number
1270482|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Quantity” (Hours) of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks||Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
1270483|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Adequacy” of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
1270484|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Disturbance” of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
1270485|NCT00357097|Secondary|Change From Average Baseline Score of Subscale of “Somnolence” in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
1270486|NCT00357097|Secondary|Percentage of Participants With “Much Improved” or “Very Much Improved” on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score range: 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5- minimally worse, 6-much worse, to 7-very much worse.|Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Percentage of Participants|||Number
1270487|NCT00357097|Secondary|Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks|International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points|Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Percentage of Participants|||Number
1270488|NCT00357097|Secondary|Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks|International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points|Baseline, Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
1270489|NCT00357097|Secondary|Change in Average BDI Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 91 and Placebo 34. High/Low BDI scores for this population were 46/2.|||Score on a Scale||Standard Deviation|Mean
1270490|NCT00357097|Secondary|Change in Average HAM-D Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 90 and Placebo 31.|||Score on a Scale||Standard Deviation|Mean
1270491|NCT00357097|Secondary|Change in Average MADRS Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 93 and Placebo 34|||Score on a Scale||Standard Deviation|Mean
1270555|NCT00356590|Secondary|Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12|Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1270492|NCT00357097|Secondary|Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline in Subjects With Signs of at Least Moderate Depression at Baseline (MADRS Score >= 18)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29|||Percentage of Participants|||Number
1270493|NCT00357097|Secondary|Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5).|||Percentage of Participants|||Number
1270494|NCT00357097|Secondary|Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15.|||Percentage of Participants|||Number
1270495|NCT00357097|Secondary|Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at week 12).|||Percentage of Participants|||Number
1270496|NCT00357097|Secondary|Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Mild-moderate Depression (BDI >= 21) at Baseline|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with BDI scores>=21: Ropinirole 75 and Placebo 28. High/Low BDI scores for this population were 46/2.|||Score on a Scale||Standard Deviation|Mean
1270497|NCT00357097|Secondary|Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). High/Low BDI scores for this population were 46/2.|||Score on a Scale||Standard Deviation|Mean
1270498|NCT00357097|Secondary|Average Change of the HAM-D Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Moderate Depression (HAM-D Score >= 15) at Baseline|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54(severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15: Ropinirole 93 and Placebo 33|||Score on a Scale||Standard Deviation|Mean
1270499|NCT00357097|Secondary|Average Change of the HAM-D (Hamilton Depression Rating Scale, 17-item-Version) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low HAM-D scores for this population were 27/5.|||Score on a Scale||Standard Deviation|Mean
1270500|NCT00357097|Secondary|Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of at Least Moderate Depression (MADRS Score: >=18)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29. The high/Low scores for the mITT population were 32/11.|||Score on a Scale||Standard Deviation|Mean
1270501|NCT00357097|Primary|Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low scores for this population were 32/11.|||Score on a Scale||Standard Deviation|Mean
1270503|NCT00357032|Secondary|Duration of Response|From time of documented treatment response (CR or PR) until progression of death. Complete Response (CR): Repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia. Partial Resonse (PR): requires the same hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to a post-treatment value of 5% to 25% in the bone marrow aspirate. (If the pre-treatment blast percentage was 50-100%, this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49%, this must decrease by at least half to a value greater than 5%.) A value ≤ 5% is also considered a PR if Auer rods are present.|Up to 1 year|There were no formal CRs or PRs seen among the first cohort of 12 patients, resulting in the study's closure. As a result data were not collected.The study was completed as planned and stopped due to futility as written per protocol. It was not terminated prematurely as accrual proceeded per protocol.||||||
1270504|NCT00357032|Secondary|Overall Survival|Survival endpoints will be summarized by the method of Kaplan-Meier|Up to 1 year||||Months||95% Confidence Interval|Median
1270505|NCT00357032|Primary|Complete Response Rate|Clinical responses were measured according to International Working Group criteria. Bone marrow studies were repeated at a minimum of every three cycles. Per International Working Group criteria: Complete Response (CR): Repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia|Up to 1 year||||percentage of subjects|||Number
1270506|NCT00357006|Secondary|Change in Hormone Levels Over Trial Duration||Baseline and weeks 1, 4 and 8.|||||||
1270507|NCT00357006|Secondary|Scores on Adverse Symptom Checklist at Trial Completion||Baseline and weeks 1, 2, 4, 6, 8|||||||
1270508|NCT00357006|Secondary|Scores on MADRS at Trial Completion||Baseline and week 8|||||||
1270509|NCT00357006|Secondary|Cognitive Performance (RBANS Scores)||baseline and week 8|||||||
1270510|NCT00357006|Primary|Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.|Baseline and week 8||||units on a scale||Standard Deviation|Mean
1270511|NCT00356915|Secondary|Clinical Improvement Compared to Placebo|"Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.~The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.~0 = Clinical Cure: No evidence of onychomycosis.~1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis."|12 months|Intent to treat (ITT)|||percentage of participants|||Number
1270512|NCT00356915|Secondary|Clinical Improvement of the Target Toenail|"Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.~The Investigator’s Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.~0 = Clinical Cure: No evidence of onychomycosis.~1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis."|12 months||||percentage of participants|||Number
1270513|NCT00356915|Primary|Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules|The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator’s Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.|12 months|Intent to treat (ITT).|||Percentage of participants|||Number
1270514|NCT00356915|Primary|Clinical and Mycological Cure of Target Toenail|"This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets.~Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail."|1 year|Intent to treat (ITT).|||Percentage of participants|||Number
1270515|NCT00356889|Secondary|Duration of Response|Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987).|From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years|There were 6 patients with a confirmed Partial Response.|||months||95% Confidence Interval|Median
1270516|NCT00356889|Secondary|Time to Disease Progression|Estimated using the method of Kaplan-Meier (1958).|From registration to documentation of disease progression, assessed up to 3 years||||months||95% Confidence Interval|Median
1270517|NCT00356889|Secondary|Survival Time|Estimated using the method of Kaplan-Meier (1958).|From registration to death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
1270518|NCT00356889|Primary|Number of Confirmed Tumor Responses.|"Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the target lesions.~A confirmed tumor response is defined to be either a Complete Response or a Partial Response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor responses will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment and had one post-baseline disease assessment will be evaluable for response. Forty-nine of the 53 eligible patients had at least one post-baseline disease assessment and were evaluable for this endpoint."|After 6 courses of treatment. Each course lasts 28 days.||||participants|||Number
1270520|NCT00356863|Secondary|MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument.|MacNew questionnaire (MACNEW). A self-administered heart disease-specific health-related quality of life (HRQL) instrument. The MacNew is a modification of the original interviewer-administered Quality of Life after Myocardial Infarction [QLMI] instrument. It addresses three major HRQL domains, the Emotional, Physical, and Social domains which can be combined to give a Global HRQL score. The MacNew consists of 27 items. The total mean score ranges between 1 and 7, where higher score means better HRQL.|1 year|The N for this outcome is the number of patients for whom there are follow-up data after one year.|||Scores on a scale||Standard Deviation|Mean
1270521|NCT00356863|Other Pre-specified|Physical Activity|"Self-reported physical activity using a physical activity questionnaire validated in Hebrew. Details of the study validating the instrument: Development of a Hebrew questionnaire to be used in epidemiological studies to assess physical fitness--validation against sub maximal stress test and predicted VO2max. Ken-Dror G, Lerman Y, Segev S, Dankner R. Harefuah. 2004 Aug;143(8):566-72, 623. Hebrew. PMID: 15523807 VO2max=maximal oxygen uptake"|1 year|All patients who were interviewed 1-year after CABG surgery and responded to the physical activity questionnaire|||patients|||Number
1270522|NCT00356863|Other Pre-specified|Depression & Anxiety|Score in the HADS (hospital Anxiety and Depression Scale) screening for anxiety and depression. This is a 14 item scale, 7 items for anxiety and 7 items for depression. Each item can score 0-3 (0=good, 3=bad) and the total score for each scale varies between 0 (no depression/anxiety) to 21 (clinical depression/anxiety requiring medical intervention)|1 year|All patients who completed the Hospital Anxiety and Depression Scale (HADS)|||HADS score||Standard Deviation|Mean
1270523|NCT00356863|Other Pre-specified|Employment Status|Number of patients fully employed in each arm|1 year||||patients|||Number
1270524|NCT00356863|Other Pre-specified|Lifestyle Habits (i.e. Smoking)||1 year||||patients|||Number
1270525|NCT00356863|Other Pre-specified|Anthropometric Measures|Measurements of body mass index (BMI)|1 year||||kg/m^2||95% Confidence Interval|Mean
1270526|NCT00356863|Other Pre-specified|Medical Service Utilization|Visits to the emergency department during the year following CABG surgery|1 year||||ER visits|||Number
1270527|NCT00356863|Other Pre-specified|Biochemical Markers|glucose, total cholesterol, triglycerides, low density lipoprotein (LDL) cholesterol. Data regarding these biochemical markers was collected from medical available documents at the homes of the patients. In many cases this data was unavailable. Reported values are only available for a subpopulation.|1 year||||mg/dl||95% Confidence Interval|Mean
1270528|NCT00356863|Other Pre-specified|Cardiovascular Morbidity|All hospitalizations which occured during the 1 year follow-up and were due to acute myocardial infarction (International Classification of Disease 9th version (ICD-9) codes 410.), angina pectoris (ICD-9 codes 413.9), stroke/ transient ischemic attack (TIA) (ICD-9 codes 436.), and all surgical procedures which occured during the 1 year follow-up: CABG or coronary catheterizations (ICD-9 codes 36.), endarterectomies (ICD-9 codes 38.0 and 39.0).|1 year|All patients who were exposed to the educational intervention at baseline and who were contacted a year later and gave information regarding participation in cardiac rehabilitation during the follow up year.|||events|hospitalizations||Number
1270529|NCT00356863|Primary|Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups|The number of cardiac patients who participated in cardiac rehabilitation programs during the year following coronary artery bypass grafting surgery in the control and the intervention groups.|1 year|All patients alive at 1-year follow up who gave information on participation in cardiac rehabilitation programs (CRPs) at any time during the year following surgery (and before follow up assessment). This information was obtained via a face-to-face interview or by telephone interview.|||participants|||Number
1270530|NCT00356811|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.|From the start of study medication until 28 days after the last dose (up to Study Week 381)|ITT Population|||Participants|||Number
1270531|NCT00356811|Secondary|Overall Survival|Overall survival is defined as the interval between the date of treatment start and the date of death due to any cause. For participants who did not die, follow-up was censored as the date of last contact. For participants who did not die, follow-up was censored at the date of last contact.|From the date of the first dose until the date of death due to any cause (up to Week 86)|ITT Population|||weeks||95% Confidence Interval|Median
1270532|NCT00356811|Secondary|Progression-free Survival, as Assessed by the IRC and the Investigator|Progression-free survival is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to any cause, whichever occurs first. Participants who did not progress in their disease were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.|From the start date of treatment until the date of radiological disease progression or death due to any cause, whichever occurs first (up to Week 86)|ITT Population|||weeks||95% Confidence Interval|Median
1270556|NCT00356590|Secondary|Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12|Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1271221|NCT00351299|Secondary|Length of Ventilator Support|Number of days on mechanical ventilation|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end||||days||Inter-Quartile Range|Median
1270533|NCT00356811|Secondary|Time to Progression, as Assessed by the IRC and the Investigator|Time to progression is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to breast cancer, whichever occurs first. Participents who did not progress or die were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.|From the start date of treatment until the date of radiological disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population|||weeks||95% Confidence Interval|Median
1270534|NCT00356811|Secondary|Time to Response, as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From randomization until the first documented evidence of a PR or CR (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.|||Weeks||95% Confidence Interval|Median
1270535|NCT00356811|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From randomization until the first documented evidence of a PR or CR (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.|||weeks||95% Confidence Interval|Median
1270536|NCT00356811|Secondary|Duration of Response (DoR), as Assessed by the Investigator|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.|||Weeks||95% Confidence Interval|Median
1270537|NCT00356811|Secondary|Duration of Response (DoR), as Assessed by the IRC|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.|||weeks||95% Confidence Interval|Median
1270538|NCT00356811|Secondary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR or PR, per RECIST. The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the Investigator. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)|ITT Population|||Participants|||Number
1270557|NCT00356590|Secondary|Percent Improvement in HAQ DI From Baseline to Month 12|Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1270539|NCT00356811|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)|OR is defined as the number of participants achieving either a CR or PR, per Response Evaulation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)|Intent-to-Treat (ITT) Population: all participants who received study medication.|||Participants|||Number
1270540|NCT00356759|Secondary|Patients With Dose Changes|Number of patients with at least one change of maintenance dose during the 12-month study period|12 months|Intention to treat|||participants|||Number
1270541|NCT00356759|Secondary|Number of Extreme INR Results|Number of INRs outside the range 1.5-4.4|12 months|Intention to treat|||Number of tests|||Number
1270542|NCT00356759|Secondary|Secondary Safety Outcome: Number of Patients With Extreme INR Results|Secondary safety outcome is number of patients with at least one INR below 1.5 or above 4.4|12 months|Intention to treat|||participants|||Number
1270543|NCT00356759|Secondary|Secondary Safety Outcome: Major Bleeding|Number of patients with any objectively verified, independently adjudicated major bleeding event during the 12-month study period. Major bleeding was defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria|12 months|Intention to treat|||participants|||Number
1270544|NCT00356759|Secondary|Secondary Efficacy Outcomes: Thromboembolic Events|Number of patients with any objectively verified, independently adjudicated thromboembolic event during the 12-month study period|12 months|Intention to treat|||participants|||Number
1270545|NCT00356759|Primary|Primary Outcome Measure: Time in Therapeutic Range|Percent time in therapeutic range calculated by linear interpolation.|12 months|Intention to treat population|||percentage of time||Standard Deviation|Mean
1270546|NCT00356603|Secondary|Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate|The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented.|Up to 2 months|FAS Population.|||Percentage of participants|||Number
1270547|NCT00356603|Secondary|Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product|The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was “Was the kit product easy to use?”, question 2 was “Do you want to use the kit product in the future?” and question 3 was “Do you consider that the kit product is necessary for the treatment of your illness?”. The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented.|Up to 2 months|FAS Population.|||Participants|||Count of Participants
1270548|NCT00356603|Primary|Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)|Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.|30 minutes or 60 Minutes after each administration|Full Analysis Set (FAS) Population included patients who self-administered the study product and have at least one efficacy data.|||Percentage of participants||95% Confidence Interval|Number
1270549|NCT00356590|Secondary|Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale|Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2|||Units on a scale||Full Range|Mean
1270550|NCT00356590|Secondary|Change From Baseline to Year 2 in Sharp Score Erosion Subscale|Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2|||Units on a scale||Full Range|Mean
1270551|NCT00356590|Secondary|Change From Baseline to Year 2 in Total Sharp Score|Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2|||Units on a scale||Full Range|Mean
1270552|NCT00356590|Primary|Death|Death of the participant on study up to 30 days after the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participants|||Number
1270553|NCT00356590|Secondary|Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12|Percent improvement in the duration of morning stiffness from baseline to month 12|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1270554|NCT00356590|Secondary|Percent Improvement in C-Reactive Protein From Baseline to Month 12|Percent improvement in C-reactive protein from baseline to month 12|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1280714|NCT00263328|Secondary|Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit||Months 12 and 24|Safety population|||cells/uL||Standard Deviation|Mean
1270558|NCT00356590|Secondary|Percent Improvement in Swollen Joint Count From Baseline to Month 12|Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1270559|NCT00356590|Secondary|Percent Improvement in Tender Joint Count From Baseline to Month 12|Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1270560|NCT00356590|Secondary|Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12|"Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from no pain (0 cm) to severe pain (10 cm)."|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1270561|NCT00356590|Secondary|Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12|Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms|Baseline and Month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1270562|NCT00356590|Secondary|Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12|Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
1270563|NCT00356590|Secondary|Standardized Incidence Rate for All SEER Cancers|Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.|Up to 8 years|All participants who received at least one dose of etanercept|||Standardized incidence rate||95% Confidence Interval|Mean
1270564|NCT00356590|Secondary|ACR70 Response at Month 12|American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12|||Participants|||Number
1270565|NCT00356590|Secondary|ACR50 Response at Month 12|American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12|||Participants|||Number
1270566|NCT00356590|Secondary|ACR20 Response at Month 12|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12|||Participants|||Number
1270567|NCT00356590|Secondary|Dosing Period|Duration of etanercept dosing|Up to 8 years|All participants who received at least one dose of etanercept|||Days||Standard Deviation|Mean
1270568|NCT00356590|Primary|Total Exposure Adjusted Rate of Serious Adverse Events|Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Events per 100 patient-years|||Number
1270569|NCT00356590|Primary|Serious Infectious Event|Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participants|||Number
1270570|NCT00356590|Primary|Lymphoma|Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participants|||Number
1270571|NCT00356590|Primary|Malignancy|Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participants|||Number
1270572|NCT00356590|Primary|Total Exposure Adjusted Rate of Lymphomas|Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Lymphomas per 100 participant-years|||Number
1270573|NCT00356590|Primary|Total Exposure Adjusted Rate of Serious Infectious Events|Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Events per 100 participant-years|||Number
1270574|NCT00356590|Primary|Total Exposure-Adjusted Rate of Deaths|Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Deaths per 100 participant-years|||Number
1270575|NCT00356590|Primary|Total Exposure-Adjusted Rate of Malignancies|Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Malignancies per 100 participant-years|||Number
1270604|NCT00356369|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|At Year 1, Year 2, Year 3, Year 4 and Year 5|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
1270576|NCT00356590|Secondary|ACR20 Response at Month 3|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)|Baseline and month 3|All enrolled participants who received at least one dose of etanercept and had available data at month 3|||Participants|||Number
1270577|NCT00356590|Primary|Total Exposure to Etanercept With Gaps|Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participant-years|||Number
1270578|NCT00356525|Secondary|Time to Treatment Failure||baseline to stopping treatment (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.|||months||Standard Deviation|Mean
1270579|NCT00356525|Secondary|Duration of Response||time of response to progressive disease (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.|||months||Standard Deviation|Mean
1270580|NCT00356525|Secondary|Time to Progressive Disease||baseline to measured progressive disease (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.|||months||Standard Deviation|Mean
1270581|NCT00356525|Secondary|Overall Survival|Overall survival is the number of participants who were alive when the trial was terminated.|baseline to trial termination (17.5 months)|Number of randomized participants in each category.|||participants alive|||Number
1270582|NCT00356525|Primary|Objective Tumor Response|Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to time of response (up to 17.5 months)|Number of randomized participants in each category.|||participants|||Number
1270583|NCT00356434|Secondary|DVT Prevention|positive DVT on ultrasound|up to 3 months|Data was not collected for this outcome measure, as the study was terminated prematurely.||||||
1270584|NCT00356434|Primary|Patient Compliance|Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded|for 1-7 days during hospitalization|Data was not collected for this outcome measure, as the study was terminated prematurely.||||||
1270585|NCT00356434|Primary|Comfort Level|Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort).|once during first 7 days of hospitalization||||units on a scale||Full Range|Mean
1270586|NCT00356421|Other Pre-specified|Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 6, 24, and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||scores on scale|||Number
1270587|NCT00356421|Secondary|Change in Fasting Lipids From Baseline|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 24 and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||mg/dl||Standard Deviation|Mean
1270588|NCT00356421|Other Pre-specified|Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 6, 24, and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||scores on scale|||Number
1270589|NCT00356421|Secondary|Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||mg/dl|||Number
1270590|NCT00356421|Secondary|Change From Baseline in Prandial Insulin Doses|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||IU||Standard Deviation|Mean
1270591|NCT00356421|Secondary|Change From Baseline in Basal Insulin Doses|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||International Units (IU)||Standard Deviation|Mean
1270605|NCT00356369|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
1270592|NCT00356421|Secondary|Change From Baseline in Body Mass Index|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||kilograms per meter squared (kg/m2)||Standard Deviation|Mean
1270593|NCT00356421|Secondary|Change From Baseline in Body Weight|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||kg||Standard Deviation|Mean
1270594|NCT00356421|Secondary|Change From Baseline in Insulin Antibody Levels|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 24 and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||ml||Standard Deviation|Mean
1270595|NCT00356421|Secondary|Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||mg/dl||Standard Deviation|Mean
1270596|NCT00356421|Secondary|Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||mg/dl||Standard Deviation|Mean
1270597|NCT00356421|Secondary|Change From Baseline in FPG|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||milligrams per deciliter (mg/dl)||Standard Deviation|Mean
1270598|NCT00356421|Secondary|Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||percent|||Number
1270599|NCT00356421|Secondary|Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||percent|||Number
1270600|NCT00356421|Secondary|Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||percent|||Number
1270601|NCT00356421|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||percent|||Number
1270602|NCT00356408|Secondary|Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.|Crohn’s disease activity index (CDAI) is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.|Week 34 in this study|All subjects in the the Intent to Treat (ITT) population are included in this analysis.|||percentage of subjects|||Number
1270603|NCT00356408|Primary|Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)|Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.|During this study (maximum 122 weeks)|All subjects in the the Intent to Treat (ITT) population are included in this analysis.|||subjects|||Number
1270750|NCT00355199|Primary|Event Free Survival|EFS was defined from the time of the study entry to any treatment failure including disease progression or discontinuation of treatment for any reason or date of the last follow-up visit|36 months from end of therapy||||percentage of EFS at 3 years follow-up||95% Confidence Interval|Number
1270606|NCT00356369|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to 31 Days after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
1270607|NCT00356369|Secondary|Number of Subjects With AEs Resulting in Emergency Rooms Visits||From Day 0 up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
1270608|NCT00356369|Secondary|Number of Subjects With Rash||From Day 0 up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
1270609|NCT00356369|Secondary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
1270610|NCT00356369|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
1270611|NCT00356369|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
1270612|NCT00356369|Secondary|Concentration of Anti-PS Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.|At Year 3|The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.|||μg/mL||95% Confidence Interval|Geometric Mean
1270613|NCT00356369|Secondary|Number of Subjects With Anti-PS Antibodies|The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.|At Year 3|The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.|||Participants|||Count of Participants
1270614|NCT00356369|Secondary|Concentration of Anti-PS Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.|At Year 2|The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point..|||μg/mL||95% Confidence Interval|Geometric Mean
1270615|NCT00356369|Secondary|Number of Subjects With Anti-PS Antibodies|The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.|At Year 2|The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.|||Participants|||Count of Participants
1270616|NCT00356369|Secondary|Concentration of Anti-PS Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.|At Year 1|The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.|||μg/mL||95% Confidence Interval|Geometric Mean
1270617|NCT00356369|Secondary|Number of Subjects With Anti-PS Antibodies|The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.|At Year 1|The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.|||Participants|||Count of Participants
1270618|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 5|The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.|||Titer||95% Confidence Interval|Geometric Mean
1270647|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Posttreatment, 8 weeks|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270619|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 5|The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.|||Participants|||Count of Participants
1270620|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 4|The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.|||Titer||95% Confidence Interval|Geometric Mean
1270621|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 4|The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.|||Participants|||Count of Participants
1270622|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 3|The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.|||Titer||95% Confidence Interval|Geometric Mean
1270623|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 3|The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.|||Participants|||Count of Participants
1270624|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 2|The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.|||Titre||95% Confidence Interval|Geometric Mean
1270625|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 2|The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.|||Participants|||Count of Participants
1270626|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 1|The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.|||Titer||95% Confidence Interval|Geometric Mean
1270627|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 1|The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.|||Participants|||Count of Participants
1270628|NCT00356369|Secondary|Concentration of Anti-TT Antibodies|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1270629|NCT00356369|Secondary|Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies|Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1270630|NCT00356369|Secondary|Concentration of Anti-PS Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1270631|NCT00356369|Secondary|Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies|The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1270632|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titer||95% Confidence Interval|Geometric Mean
1270783|NCT00355030|Secondary|Bone Age|Bone age measured using the X-Ray of left hand and wrist.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.|||years||Standard Deviation|Mean
1270633|NCT00356369|Secondary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128.|Prior to and 1 Month after vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from whom immunogenicity data were available.|||Participants|||Count of Participants
1270634|NCT00356369|Primary|Occurrence of Any Grade 3 Systemic Symptoms|"Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm).~General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C."|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
1270635|NCT00356369|Primary|Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)|Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.|One month post vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Percentage of subjects||95% Confidence Interval|Number
1270636|NCT00356304|Secondary|Medication Attitudes||Measured at Month 5|||||||
1270637|NCT00356304|Secondary|Beck Depression Inventory-II (BDI-II)|"The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3.~0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression. Higher total scores indicate more severe depressive symptoms."|Measured at Month 5||||units on a scale||Standard Error|Mean
1270638|NCT00356304|Secondary|Treatment Retention||Measured at Month 5|||||||
1270639|NCT00356304|Primary|Medication Adherence, as Measured by Electronic Pill Container|Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.|Measured immediately post-treatment and at Months 2 and 5 months follow-ups|We used an ITT with LOCF. These figures represent outcomes at 5 months.|||Percentage of Days||Standard Error|Mean
1270640|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 12|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270641|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 6|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270642|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 3|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270643|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Posttreatment, 8 weeks|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270644|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 12|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270645|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 6|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270646|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 3|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270648|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Baseline|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270649|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Baseline|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
1270650|NCT00356265|Primary|α1-adrenoceptor Vasoreactivity With Endogenous ADMA||up to 8 hours|The main goal of the study was to compare vasoreactivity across the three groups. Given the fact that we struggled to recruit matched hypertensive and normotensive control population, we were not able to achieve the goals of the study and therefore, ADMA levels were not measured.||||||
1270651|NCT00356265|Primary|α1-adrenoceptor Vasoreactivity With L-NMMA|"Vasoreactivity is defined as Forearm blood flow, dose response curve; ml per minute per log of phenylephrine, or FABF ml/min/logPE;~The x axis is the ml/min value and the y axis is the log Phenylephrine concentration."|up to 8 hours|Based on the data from the 12 participants, and the early termination, no analysis was performed on the two hypertensive participants' data.|||ml/min x 1/log[PE]||Standard Error|Mean
1270652|NCT00356200|Primary|Change in Target Lesion Score at Week 4 Compared to Baseline|Change in score from 0-14 of target lesion disease activity based on scaling, erythema, and induration as determined by a physician assessor at week 4 compared to baseline (with 0 being no disease activity and 14 being maximum disease activity).|Baseline to week 4|all 5 patients per cohort completed the visit at week 4|||units on a scale||Standard Deviation|Mean
1270653|NCT00356200|Secondary|Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.|Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 4 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).|Baseline to week 4|all 5 patients per cohort completed the visit at week 4|||mm||Standard Deviation|Mean
1270654|NCT00356187|Secondary|Clinical Outcome Measurements|Ventilator days, ICU and hospital days, and in-hospital mortality|ICU admission date to ICU discharge or death|Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.||||||
1270655|NCT00356187|Secondary|Alterations in Neuroendocrine and Immunoinflammatory Measurements|blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction|ICU admission date to ICU discharge or death|Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.||||||
1270656|NCT00356187|Secondary|Changes in Protein Metabolism Measurements|net nitrogen balance, fat-free mass, and fat mass|ICU admission date to ICU discharge or death|Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.||||||
1270657|NCT00356187|Primary|Change in REE vs. Controls||ICU admission date to ICU discharge or death|Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.||||||
1270658|NCT00356148|Secondary|Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group).||1 month||||Monetary unit in Turkish Liras||Standard Error|Mean
1270659|NCT00356148|Primary|Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group).||1 month|Analysis was intent-to-treat|||participants|||Number
1270660|NCT00356135|Secondary|Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria|Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed.|End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug|Safety Population - all randomized participants.|||Participants|||Number
1270661|NCT00356135|Secondary|Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week|Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation.|1 week after randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.|||correlation coefficient|||Number
1270662|NCT00356135|Secondary|Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks|Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA).|2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.|||percent residual platelet aggregation||Standard Deviation|Mean
1270784|NCT00355030|Secondary|Percentage of Children With Normal Adult Height SDS|Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS)|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit.|||percentage of participants|||Number
1270663|NCT00356135|Secondary|Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event|Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event.|End of 14 day open label|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. Grouped according to clopidogrel use at time of ACS event and no clopidogrel use at time of ACS event.|||percent maximum platelet aggregation (%)||Standard Deviation|Mean
1270664|NCT00356135|Secondary|Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks|Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).|2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.|||percent maximum platelet aggregation (%)||Standard Deviation|Mean
1270665|NCT00356135|Primary|Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)|Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).|1 week after first dose of randomized study drug|The primary analysis population was the pharmacodynamic (PD) population which included all randomized participants who had blood draws for MPA at 1 week after randomization who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.|||percent maximum platelet aggregation (%)||Standard Error|Least Squares Mean
1270666|NCT00356122|Secondary|Number of Participants With Treatment-related Toxicities|"Treatment-related toxicities were serious and non-serious adverse events (AE) considered related to study treatment by the investigator.~AEs were any unfavorable and unintended signs, symptoms, syndromes, or illnesses that developed or worsened during the observation period, and included abnormal results from diagnostic procedures. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, appeared as a congenital anomaly or were considered medically important by the investigator."|From baseline up to 30 days after treatment discontinuation|All participants who received at least one dose of study treatment|||Participants|||Number
1270667|NCT00356122|Secondary|Overall Survival (OS)|OS was measured from the date of registration to the date of death due to any cause, or to the date of last contact (for censored observations). OS was assessed by the Kaplan-Meier method and the estimates of median survival time with 95% CI are reported.|Baseline to OS (up to 24 months after the first treatment)|All participants registered to receive study treatment|||Months||95% Confidence Interval|Median
1270668|NCT00356122|Secondary|Time-to-treatment Failure (TTF)|"Treatment failure was defined as an event which lead to the participant’s withdrawal from the study treatment due to lack of efficacy, disease progression, adverse events, or due to a participant's request as recorded in the Case Report Form (CRF), death, or use of other anticancer therapy.~TTF was assessed using Kaplan-Meier method, and the median TTF with 95% CIs was computed using the Brookmeyer and Crowley method."|Baseline to treatment failure (up to 24 months after the first treatment)|All participants registered to receive study treatment|||Months||95% Confidence Interval|Median
1270669|NCT00356122|Secondary|Objective Response Rate|"Objective response rate is the percentage of participants with an objective response. Improvements in tumor measurements from baseline values were assigned a status of Complete Response (CR) or Partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST). Overall objective response was the sum of CR and PR.~CR referred to the disappearance of all target lesions, and PR was at least 30% decrease in the sum of the longest diameter (LD) of target lesions, compared to the baseline sum LD. Responses were confirmed by repeat assessments within 4 to 6 weeks."|Baseline to CR or PR (up to 24 months after the first treatment)|All participants registered to receive study treatment|||Percentage of participants||95% Confidence Interval|Mean
1270670|NCT00356122|Primary|Progression-free Survival (PFS)|"PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first.~Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions."|Baseline to PFS (up to 24 months after the first treatment)|All participants registered to receive study treatment|||Months||95% Confidence Interval|Median
1270671|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||mL||Standard Error|Mean
1270672|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||mL||Standard Error|Mean
1270673|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||grams||Standard Error|Mean
1270674|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||mL||Standard Error|Mean
1270675|NCT00356057|Secondary|Mortality Rate||At six months post-procedure|Subjects enrolled|||percentage of participants analyzed|||Number
1270676|NCT00356057|Secondary|Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations||At six months post-procedure|Subjects successfully implanted with investigational system.|||percentage of participants analyzed|||Number
1270713|NCT00355615|Secondary|Percent Change in TC/HDL-C|Percent change in the ratio of TC/HDL-C after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
1270677|NCT00356057|Secondary|Changes in New York Heart Association (NYHA) Classification|"The purpose is to evaluate the change in the participant's NYHA classification.~There are four NYHA classes:~Class I: Patients with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Change from baseline to six months post-procedure|"Subjects with paired baseline and 6-month NYHA classification data. The outcome of Improved at least 1 Class represents a numerically higher NYHA class at baseline than at 6 months (e.g. NYHA class III at baseline changed to NYHA class II at 6 months)."|||Participants|||Count of Participants
1270678|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||percent||Standard Error|Mean
1270679|NCT00356057|Secondary|Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months|Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. This outcome was calculated as QOL score at baseline minus QOL score at 6 months. Therefore, a positive change in QOL score represents an improvement in quality of life, while a negative change in QOL score represents a worsening.|Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month QOL data. A positive score represents improvement from baseline to 6-months.|||units on a scale||Standard Error|Mean
1270680|NCT00356057|Secondary|Change in Six-minute Walk Test||Change from baseline to 6 months post-procedure|Subjects with paired baseline and 6-month six-minute walk test data.|||Meters||Standard Error|Mean
1270681|NCT00356057|Primary|Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications. All Stratos systems (in both the biV and RV pacing arms) were evaluated together as pre-specified in the protocol.|At six months post-procedure||||Participants|||Count of Participants
1270682|NCT00356057|Primary|Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications.|At six months post-procedure||||Participants|||Count of Participants
1270683|NCT00356057|Primary|Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months|Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))|Change from baseline to six months post-procedure|Patients included in this analysis are those patients with complete six minute walk test and Quality of Life data at both baseline and the six-month follow-up.|||Percent Change||Standard Error|Mean
1270684|NCT00356031|Secondary|Disease Free Survival|The median amount of time from the end of treatment until to distant recurrence. Distant recurrence is when cancer spreads to areas in the body away from the primary cancer site.|3 years||||Months||Full Range|Median
1270685|NCT00356031|Secondary|Distant Recurrence|The number of participants with distant recurrence at the time of last follow-up. Distant recurrence is when cancer has spread (metastasized) to areas farther away from where the primary cancer site is.|3 years||||Participants|||Count of Participants
1270686|NCT00356031|Secondary|Local Control Rate|The number of patients with local recurrence after a median follow-up of 24 months. Local recurrence is defined as disease progression (new cancer growth) at the primary cancer site.|3 years||||Participants|||Count of Participants
1270687|NCT00356031|Secondary|Average Change in Blood Flow, Blood Volume,and Permeability Surface Area|The percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.|3 years||||Percent Reduction||Full Range|Mean
1270688|NCT00356031|Secondary|Change in Median Microvessel Density (MVD) After Bevacizumab Alone|The percentage change in median microvessel density (MVD) after Bevacizumab treatment alone|baseline and 3 years||||percentage of change in MVD||95% Confidence Interval|Median
1270689|NCT00356031|Primary|Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.|The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.|3 years||||participants|||Number
1270728|NCT00355472|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations|Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.|0-7 days post final dose||||ng/mL||Standard Deviation|Mean
1270690|NCT00355914|Primary|Oswestry Disability Index|Oswestry Disability Index 2.0 (ODI): ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).|Baseline, 3, 6, 12, 18, and 24 months post-treatment.|An intent-to-treat-analysis was performed on all patients utilizing the last follow-up data. Initial data were utilized in the patients who dropped out of the study without further follow-up after the first treatment.|||units on a scale||Standard Deviation|Mean
1270691|NCT00355914|Primary|Average Numeric Rating Scale|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.|Baseline, 3, 6, 12, 18, and 24 months post-treatment||||units on a scale||Standard Error|Mean
1270692|NCT00355797|Primary|Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test)|Patients completing the orthostatic test in all three pacing modes and that had at least 80% pacing during the test in the CLS and R pacing modes are included in the analysis. The mean pulse pressure is provided.|within 45 days of enrollment||||mmHg||Standard Deviation|Mean
1270693|NCT00355797|Secondary|Change in 6-minute Walk Test Distance|Change in number of 10 foot repetitions between baseline and 12-month visit were examined.|baseline and 12 months|Subjects completing the 6 minute walk at both enrollment and at the 12-month visit were included in intention to treat analysis.|||repetitions||Standard Deviation|Mean
1270694|NCT00355797|Secondary|Change in New York Heart Association (NYHA) Class|Number of subjects with improved, no change, or worsened NYHA classification at the 12-month visit, as compared to baseline. NYHA classifications (I to IV) are used to assess the various stages of heart failure, with Class I relating to mild heart failure and Class IV relating to severe heart failure.|baseline and 12 months|Subjects with NYHA classifications at both enrollment and at the 12-month visit were analyzed using intention to treat.|||participants|||Number
1270695|NCT00355797|Secondary|Cardiac Symptoms|Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.|12 months|All subjects answering questions about current cardiac symptoms at the 12-month visit were included in this intention to treat analysis.|||participants|||Number
1270696|NCT00355797|Secondary|Atrial Fibrillation (AF) Burden|AF burden was measured at 12 months as the percentage of total atrial beats that are at or above 160 bpm.|12 months|Percentage of atrial burden was collected for subjects utilizing dual chamber pacing that completing a 12-month follow-up visit.|||percentage of atrial beats||Standard Deviation|Mean
1270697|NCT00355797|Secondary|Mode Reprogramming|Number of subjects with device reprogramming from dual (atrial and ventricular pacing) to single chamber (ventricular pacing only) or from single (ventricular pacing only) to dual chamber (atrial and ventricular pacing) during the 12 month follow-up.|12 months|Subjects completing at least one follow-up visit were analyzed using intention to treat.|||participants|||Number
1270698|NCT00355797|Secondary|Change in Quality of Life|Change in Quality of life (QOL) score was determined from baseline to the 12 month follow-up visit. The QOL utilized the physical functioning scale of the SF-36 v2, in which a higher score indicates a better health perception. Best possible score was 57.03 while the worst possible score was 14.94.|baseline and 12 months|Subjects completing a QOL at both baseline and 12 month follow-up were included in an intention to treat analysis.|||score||Standard Deviation|Mean
1270699|NCT00355797|Primary|Performance of Activities of Daily Living Tests (6-minute Walk and Sweep)|Six-minute walk test and sweep test results for subjects completing tests in all three pacing modes and requiring at least 80% pacing during both tests in the CLS and R pacing modes. The mean composite of repetitions (six minute walk plus sweep) are presented.|within 45 days of enrollment|Patients requiring at least 80% pacing during both tests in the CLS and accelerometer pacing modes are included.|||repetitions||Standard Deviation|Mean
1270700|NCT00355784|Primary|Changes in Fat-free Mass||2 weeks||||kg||Standard Error|Mean
1270701|NCT00355784|Primary|Changes in Fat Mass||2 weeks||||kg||Standard Error|Mean
1270702|NCT00355784|Primary|2 Week Skeletal Muscle Protein Synthesis|after an overnight fast|2 weeks|per protocol|||skeletal muscle protein%/hour||Standard Error|Mean
1270703|NCT00355784|Primary|Whole Body Protein Turnover After 2 Week Intervention|whole body proteolytic rate (leucine Ra)|2 weeks|per protocol|||µmol/kg fat free mass/min||Standard Error|Mean
1270704|NCT00355784|Primary|Lipolytic Rate||2 weeks|per protocol|||µmol/min||Standard Error|Mean
1270705|NCT00355784|Primary|Baseline Skeletal Muscle Protein Synthesis|after an overnight fast|baseline|per protocol|||skeletal muscle protein%/hour||Standard Error|Mean
1270706|NCT00355784|Primary|Baseline Whole Body Protein Turnover|Whole body proteolytic rate (Leucine Ra)|baseline|per protocol|||μmol/kg fat free mass/min)||Standard Error|Mean
1270707|NCT00355784|Primary|Changes in Body Weight||2 weeks|per protocol|||kg||Standard Error|Mean
1270708|NCT00355784|Primary|24 Hour Average Plasma Growth Hormone Concentration||2 weeks|per protocol|||ng/mL||Standard Error|Mean
1270709|NCT00355706|Primary|Oswestry Disability Index|Oswestry Disability Index (ODI) – ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).|24 months||||units on a scale||Standard Deviation|Mean
1270710|NCT00355706|Other Pre-specified|Opioid Intake|Opioid intake(morphine equivalence mg)|24 months||||mg/day||Standard Deviation|Mean
1270711|NCT00355706|Primary|Numeric Rating Scale|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.|2 years||||units on a scale||Standard Deviation|Mean
1270712|NCT00355615|Secondary|Percent Change in Non-HDL-C/HDL-C|Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
1270748|NCT00355199|Secondary|Disease Free Survival|DFS was defined from the time of documentation of CR to time to relapse or death as a result of lymphoma or acute toxicity of treatment or date of the last follow-up visit|36 months from end of therapy||||percentage of DFS at 3 years follow-up||95% Confidence Interval|Number
1270714|NCT00355615|Secondary|Percent Change in LDL-C/HDL-C|Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment|After 12 week of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
1270715|NCT00355615|Secondary|Percent Change in ApoB/ApoA-1|Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
1270716|NCT00355615|Secondary|Percent Change in Apolipoprotein B (ApoB)|Percent change in ApoB after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
1270717|NCT00355615|Secondary|Percent Change in Apolipoprotein A-1 (ApoA-1)|Percent change in ApoA-1 after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
1270718|NCT00355615|Secondary|Percent Change in Total Cholesterol (TC)|Percent change from baseline in total cholesteral after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percent change||Standard Deviation|Mean
1270719|NCT00355615|Secondary|Percent Change in Triglycerides (TG)|Percent change in tryglycerides (TG) after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percent change||Standard Deviation|Mean
1270720|NCT00355615|Secondary|Percent Change in Non-HDL-C at 12 Weeks|Percent change in non-HDL-C at 12 weeks|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percent change||Standard Deviation|Mean
1270721|NCT00355615|Secondary|Percent Change in HDL-C|Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percent change||Standard Deviation|Mean
1270722|NCT00355615|Secondary|Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment|Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group|12 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||Percent of Participants|||Number
1270723|NCT00355615|Secondary|Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12)|Percent change from baseline in LDL-C after six week of treatment|6 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percentage||Standard Deviation|Mean
1270724|NCT00355615|Primary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase|Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100|12 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percentage||Standard Deviation|Mean
1270725|NCT00355472|Secondary|Time to Progression (TTP)|TTP was defined as the period from the day starting the first KW-0761 dosing to the day of PD identification (or the day of death if the subject died before PD was documented). Subjects were to be censored at the time of starting post-treatment, if it was started before PD identification.|Baseline to response||||days||Full Range|Median
1270726|NCT00355472|Primary|Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)|The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.|0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period).|t1/2|||hours||Standard Deviation|Mean
1270727|NCT00355472|Primary|Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)|The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.|0-7 days post final dose|AUC0-7 days|||ng·h/mL||Standard Deviation|Mean
1270729|NCT00355472|Secondary|Antitumor Effect|The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).|50 days||||participants|||Number
1270730|NCT00355472|Primary|Maximum Tolerated Dose (MTD)|The dose level at which Dose-Limiting Toxicity (DLT) was recognized was to be regarded as Maximum Tolerated Dose (MTD), and the dose level below MTD by one level was to be regarded as the recommended dose level (when MTD was not reached, 1.0 mg/kg was to be regarded as the recommended dose level) and 3 more subjects were to be newly added to the recommended dose level.|28 days||||mg/kg|||Number
1270731|NCT00355472|Primary|Incidence of Dose-Limiting Toxicities (DLTs)|Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.|28 days||||participants|||Number
1270732|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|24 hours||||NRS Score||Standard Deviation|Mean
1270733|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|2 hours||||NRS Score||Standard Deviation|Median
1270734|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|1 hours|All participants included.|||NRS Score||Standard Deviation|Mean
1270735|NCT00355394|Secondary|The Number of Subjects With a NRS Score of Zero at 24 Hours.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|24 hours||||participants|||Number
1270736|NCT00355394|Secondary|The Number of Subjects With a NRS Score of Zero at One Hour.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|1 hour|All participants included.|||participants|||Number
1270737|NCT00355394|Primary|The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|2 hours|All participants included.|||participants|||Number
1270738|NCT00355368|Secondary|Number of Participants With an Failed First Intubation Attempts|defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt|within the first 90 sec following the start of induction||||participants|||Number
1270739|NCT00355368|Secondary|Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.|"The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3.~Units: measure on a scale"|during laryngoscopy and the first minute after completion of intubation||||score points||Standard Deviation|Mean
1270740|NCT00355368|Secondary|Time to Completion of Intubation|time interval between the injection of the induction agent and the first appearance of endtidal CO2|time interval between the injection of the induction agent and the first appearance of endtidal CO2||||seconds||Standard Deviation|Mean
1270741|NCT00355368|Secondary|Haemodynamic Sequelae of Intubation|any new haemodynamic alteration requiring immediate intervention|between start of induction sequence and 5 min after completion of intubation|||||||
1270742|NCT00355368|Primary|Number of Participants Exhibiting Desaturation >5%|decrease of >5% in oxygen saturation measured continuously using pulse oxymetry|at any time between the start of the intubation sequence and 2min after the completion of intubation|ITT|||participants|||Number
1270743|NCT00355342|Secondary|Percent Change From Baseline in BMD at the Total Hip|BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms).BMD at the total hip was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.|Baseline and Week 26, 52, 78, 104, 130, and 156|Safety Population. Only those participants available at the specified time points were analyzed.|||Percent Change||Standard Error|Mean
1270744|NCT00355342|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4|BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.|Baseline and Week 26, 52, 78, 104, 130, and 156|The Safety population - Safety population was defined as all randomized participants who are at least 50% compliant with taking study drug and have a post-Baseline BMD scan. Only those participants available at the specified time points were analyzed.|||Percent Change||Standard Error|Mean
1270745|NCT00355199|Secondary|Efficacy of R-HDS Conditioning as Salvage Therapy in Patients Non-responders After Four Cycles of R-CHOP 14||Through completion of salvage therapy|||||||
1270746|NCT00355199|Secondary|Toxicity|Percentage of participants with at least one reported episode of CTC grade III or IV toxic events|Through therapy completion an average of 8 months||||percentage of participants|||Number
1270747|NCT00355199|Secondary|Overall Survival|OS was defined from the time of the study entry to death as a result of any cause or date of the last follow-up visit|36 months from end of therapy||||percentage of OS at 3 years follow-up||95% Confidence Interval|Number
1270751|NCT00355147|Secondary|Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management|"Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%)~Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%."|Baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.|||participants|||Number
1270752|NCT00355147|Secondary|Medication (Statins) for Secondary Stroke Prevention Risk Factor Management|"Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%).~Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%."|baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.|||participants|||Number
1270753|NCT00355147|Secondary|Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment|"Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%)~Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%"|baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.|||participants|||Number
1270754|NCT00355147|Primary|Self-Efficacy to Manage Stroke Symptoms|Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence.|6 months|We hypothesized the intervention group would report significantly greater self-efficacy to manage stroke symptoms than the control group. Level of significance was set to .05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, & time.|||units on a scale||Standard Deviation|Mean
1270755|NCT00355147|Primary|Stroke Specific Health Related Quality of Life|"Stroke Specifc, Health Related Quality of Life (SSQoL)~Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369.~Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores.~We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05."|6 months for (SSQoL) and 3 months for Perceived Energy Subdomain|We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, and time.|||units on a scale||Standard Deviation|Mean
1270756|NCT00355134|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score|The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.|Baseline, Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. N indicates the number of participants with non-missing data at each time point."|||units on a scale||Standard Deviation|Mean
1270757|NCT00355134|Secondary|Percentage of Participants Relapse-free up to End of Study|Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.|From Baseline until the end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.|||percentage of participants||95% Confidence Interval|Number
1270758|NCT00355134|Secondary|Percentage of Participants Relapse-free up to Month 24|Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.|24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1270759|NCT00355134|Secondary|Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study|Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.|24 months and end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.|||percentage of participants||95% Confidence Interval|Number
1270760|NCT00355134|Secondary|Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study|Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan–Meier method.|24 months and end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.|||percentage of participants||95% Confidence Interval|Number
1270761|NCT00355134|Secondary|Change From Baseline in Lesion Volume at Month 24 (Core Phase)|Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.|Baseline and Month 24|Full analysis set for whom data were available. N=the number of patients with non-missing baseline and post-baseline values.|||mm^3||Standard Deviation|Mean
1270762|NCT00355134|Secondary|Number of Gadolinium-enhanced T1 Lesions|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.|Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. N indicates the number of participants with evaluable MRI data for the specified time point."|||lesions||Standard Deviation|Mean
1270763|NCT00355134|Secondary|Number of New or Newly Enlarged T2 Lesions|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.|From Baseline until Month 48|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. N indicates the number of participants with MRI data available for the specified time period."|||lesions||Standard Deviation|Mean
1270764|NCT00355134|Secondary|Percent Change From Baseline in Brain Volume|Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.|Baseline, Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. N indicates the number of participants with data available for the specified time period."|||percent change||Standard Deviation|Mean
1270765|NCT00355134|Secondary|Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study|"ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.~A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).~ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS)."|From Baseline until end of study (up to approximately 54 months).|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.|||relapses per year||95% Confidence Interval|Number
1270766|NCT00355134|Primary|Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24|"ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.~A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).~ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS)."|24 months|Full analysis set, including all patients who were randomized and took at least one dose of study drug.|||relapses per year||95% Confidence Interval|Number
1270767|NCT00355121|Other Pre-specified|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2|Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1270768|NCT00355121|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1|Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Participants|||Number
1270769|NCT00355121|Other Pre-specified|Geometric Mean Titers Against Poliovirus After IPOL Vaccination.|Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.|Day 30 post-vaccination|Serum antibody titers were assessed in the per-protocol population. (Participants received IPOL at Visit 1 in Group 1 and 3, and at Visit 2 for Group 2|||Titers||95% Confidence Interval|Geometric Mean
1270770|NCT00355121|Secondary|Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine|Fever was defined as a maximum oral temperature of ≥ 100.4ºF.|Day 0 through Day 7 post-vaccination at Visit 1|Safety analysis was on enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1270771|NCT00355121|Secondary|Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination|Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)|Day 30 post-vaccination|Serum antibody titers were assessed in the per protocol population. Participants in Group 1 received Menactra vaccine at Visit 2, Group 3 at Visit 1.|||Titers||95% Confidence Interval|Geometric Mean
1270772|NCT00355121|Secondary|Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1|Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).|Day 30 post-vaccination 1|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)|||EU/mL||95% Confidence Interval|Geometric Mean
1270773|NCT00355121|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.|Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)|Day 30 post-vaccination (Visit 1)|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)|||Titers||95% Confidence Interval|Geometric Mean
1270774|NCT00355121|Primary|Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination|Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.|Day 30 post-vaccination (Visit 1)|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)|||Participants|||Number
1270775|NCT00355082|Secondary|The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)|Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.|Baseline and entire Continuation phase (24 Weeks)|All participants who entered the Continuation Phase|||participants|||Number
1270776|NCT00355082|Secondary|Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase|Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.|Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase|All participants who began the Continuation Phase|||percent change in seizures||Full Range|Median
1270777|NCT00355082|Secondary|Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase|The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn|The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators|||participants|||Number
1270778|NCT00355082|Secondary|Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)|Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.|Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators|||percent change in seizures||Full Range|Median
1270779|NCT00355082|Secondary|Percentage of Participants Meeting Escape Criteria in the Treatment Phase|The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.|Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators|||percentage of participants|||Number
1270780|NCT00355082|Secondary|Time to Discontinuation in the Treatment Phase|Time (days) until the participant discontinued the study|From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|Intent-to-Treat (ITT) Population: All participants who were randomized and began dosing with study drug|||Days||Standard Deviation|Mean
1270781|NCT00355082|Secondary|The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)|The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.|From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|All randomized participants in the 250 mg/day dose group who began withdrawal of background AED (Visit 5) minus any major protocol violators|||percentage of participants|||Number
1270782|NCT00355082|Primary|The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)|The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.|From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)|All randomized participants in the 300 mg/day dose group who began withdrawal of background antiepileptic drug (AED) (Visit 5) minus any major protocol violators|||percentage of participants|||Number
1270785|NCT00355030|Secondary|Difference Between Adult Height SDS and Baseline Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End up Study (up to 9 years)|All participants who received who reached final height.|||standard deviation score||Standard Deviation|Mean
1270786|NCT00355030|Secondary|Difference Between Adult Height SDS and Baseline Predicted Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height [calculated using the Bayley-Pinneau method based on height and bone age] for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End up Study (up to 9 years)|All participants who received who reached final height.|||standard deviation score||Standard Deviation|Mean
1270787|NCT00355030|Secondary|Difference Between Adult Height SDS and Target Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height [calculated as (mother’s height (SDS) + father’s height (SDS))/2] for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End of Study (up to 9 years)|All participants who received who reached final height.|||standard deviation score||Standard Deviation|Mean
1270788|NCT00355030|Secondary|Height SDS|SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual’s height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.|||standard deviation score||Standard Deviation|Mean
1270789|NCT00355030|Secondary|Height Velocity|Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.|||centimeter per year||Standard Deviation|Mean
1270790|NCT00355030|Primary|Adult Height Standard Deviation Score (SDS)|The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit.|||standard deviation score||Standard Deviation|Mean
1270791|NCT00355030|Primary|Number of Participants With One or More Drug-related Adverse Events|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug in Period 1 and all participants who entered Period 2 (safety population).|||participants|||Number
1270792|NCT00354978|Primary|Median Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.|From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 months|Analysis per protocol.|||Months||95% Confidence Interval|Median
1270793|NCT00354913|Secondary|Objective Response Rate|Percentage of participants with an objective response (complete response or partial response). Per modified Macdonald criteria and assessed by MRI, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions. Objective response = CR+PR.|69 Months|Intent-to-treat|||percentage of participants|||Number
1270794|NCT00354913|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|From the date of study treatment initiation to the date of death from any cause, assessed up to 69 months.|Intent-to-treat|||months||95% Confidence Interval|Median
1270795|NCT00354913|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months.|Intent-to-treat|||months||95% Confidence Interval|Median
1270864|NCT00354159|Secondary|Characterize Medication Usage|The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.|12 months post implant|All randomized subjects.|||Medication changes per subject month|||Number
1270796|NCT00354913|Primary|Progression-free Survival at 6 Months|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.|From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1270797|NCT00354887|Primary|Number of Participants With Overall Response|Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.|Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses|Analysis was intent-to-treat; One patient developed an acute flare of Crohn’s disease after one cycle of study treatment and was removed from study without undergoing restaging scans.|||participants|||Number
1270798|NCT00354835|Secondary|Incidence of Bladder Dysfunction|Number of patients with a summary score greater than 8.5|3-6 years after enrollment|470 participants were excluded due to ineligibility or absence of the dysfunctional voiding and incontinence symptoms questionnaire.|||Participant|||Number
1270799|NCT00354835|Secondary|Event Free Survival (EFS) by PAX Status||4 years|Only eligible patients who were tested for their fusion status and PAX partners.|||Probability||95% Confidence Interval|Number
1270800|NCT00354835|Secondary|Toxicity With GSTA1 and CYP2C9 Genotypes|Incidence of toxicity related to VAC treatment in patients with GSTA1 and CYP2C9 genotypes.|During the study|The analysis was abandoned due to low incidence of toxicity. Data were not collected.||||||
1270801|NCT00354835|Secondary|Toxicity With CYP2B6 Genotypes|Incidence of toxicity related to VAC treatment in patients with CYP2B6 genotypes.|During the study|The analysis was abandoned due to low incidence of toxicity. Data were not collected.||||||
1270802|NCT00354835|Secondary|Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype|Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.|Weeks 4-9 (the first exposure to VI)|Ineligible patients are excluded. Only patients tested for the UGT1A1 genotypes are reported and included in this analysis.|||Counts|||Number
1270803|NCT00354835|Secondary|Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15|4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study)|4 years|421 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 15.|||Probability||95% Confidence Interval|Number
1270804|NCT00354835|Secondary|Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4|4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study).|4 years|452 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 4.|||Probability||95% Confidence Interval|Number
1270805|NCT00354835|Secondary|Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC|The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.|Up to 43 weeks|Number of patients with specific adverse events.|||participants|||Number
1270806|NCT00354835|Secondary|Incidence of Toxicity|Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.|Up to 15 weeks||||Probability||95% Confidence Interval|Number
1270807|NCT00354835|Secondary|Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison|Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70.|4 years|17 ineligible participants were excluded.|||Probability||95% Confidence Interval|Number
1270808|NCT00354835|Secondary|Local Failure|Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13.|2 years|17 ineligible participants were excluded.|||Proportion of participants||95% Confidence Interval|Number
1270809|NCT00354835|Secondary|Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison|Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65.|4 years|17 ineligible participants were excluded.|||Probability||95% Confidence Interval|Number
1270810|NCT00354835|Primary|Overall Survival (OS)|Probability of being alive after 4 years in the study.|4 years||||Probability||95% Confidence Interval|Number
1270811|NCT00354835|Primary|Response Rate (RR)|Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR.|Reporting Period 1 (Weeks 1 - 15)||||Proportion||95% Confidence Interval|Number
1270812|NCT00354835|Primary|Event Free Survival (EFS)|Probability of no relapse, secondary malignancy, or death after 4 year in the study|4 years||||Probability||95% Confidence Interval|Number
1270865|NCT00354159|Secondary|Characterize Subject Survival|Death from any cause during the 12-month randomization period|12 months post implant|All randomized subjects.|||number of deaths|||Number
1271134|NCT00351936|Primary|Change From Baseline in Low-density Lipoprotein (LDL)|Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||mg/dL||Standard Deviation|Mean
1270813|NCT00354770|Primary|Massachusetts General Hospital Hairpulling Scale|There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.|Baseline and final visit after 12 weeks||||units on a scale||Standard Deviation|Mean
1270814|NCT00354744|Secondary|Toxicity|Assess immediate- and short-term toxicities of concurrent irinotecan hydrochloride and radiotherapy in these patients|2 years|||||||
1270815|NCT00354744|Secondary|Feasibility|Determine the feasibility of concurrent irinotecan hydrochloride and radiotherapy in these patients.|2 years|||||||
1270816|NCT00354744|Secondary|Early Disease Control|Improve the early disease control interval for patients with newly diagnosed, high-risk, metastatic rhabdomyosarcoma or ectomesenchymoma using intensive, interval-compression therapy (comprising vincristine, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin) that permits maximal early exposure to known effective agents.|2 years|||||||
1270817|NCT00354744|Primary|Estimate of the Percent of Patients Event Free at 4 Years Following Study Entry|Event-free survival: Time to recurrence or death as a first event estimated from a Kaplan Meier curve.|4 years|All eligible patients|||percent of participants||95% Confidence Interval|Number
1270818|NCT00354744|Primary|Tumor Response Rate|Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the “measurable” mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as “non-measurable.” Complete Response (CR): Complete disappearance of the tumor confirmed at >4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning.|Protocol week 6 evaluation|All eligible patients with protocol week tumor assessment (N=102)|||percent of participants|||Number
1270819|NCT00354679|Primary|Evaluation of Safety and Toxicity|All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.|2 years||||participants|||Number
1270820|NCT00354640|Secondary|Change in Serum Estradiol Levels|The change in serum concentrations of estradiol at baseline and 14 days was measured.|Baseline and 14 days|Participants with blood samples for trough concentrations were included.|||pmol/l||Full Range|Median
1270821|NCT00354640|Primary|Change in Blood Concentrations|The change in blood concentrations of anastrozole at baseline and 14 days was measured.|Baseline and 14 days|Participants with blood samples for trough concentrations were included.|||ng/ml||Full Range|Median
1270822|NCT00354614|Primary|Sensitivity and Specificity|Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater|Simultaneous single night recording||||percentage|||Number
1270823|NCT00354601|Primary|Objective Tumor Response|The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines|8 weeks|unable to measure due to failure to complete||||||
1270824|NCT00354601|Secondary|Quality of Life|comparison of treatment end to pre entry and day 1 of each treatment cycle.|Pre-entry, day 1, treatment end|neither patient completed study||||||
1270825|NCT00354601|Secondary|Number of Participants With Grade 3 or Higher Toxicity|summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.|Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)|tracked during incomplete treatment period|||participants|||Number
1270826|NCT00354601|Secondary|Time to Progression|Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter|Evaluated every 8 weeks during treatment|unable to analyze due to failure to complete treatment or study||||||
1270827|NCT00354484|Primary|Reported Adverse Events||anytime between baseline and end of study or time to intervention|||||||
1270828|NCT00354484|Primary|Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL||anytime between baseline and end of study or time to intervention||||participants|||Number
1270829|NCT00354432|Secondary|Quality of Life|Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.|12 weeks|Participants with baseline and 12 week quality of life data.|||units on a scale||Standard Error|Least Squares Mean
1270830|NCT00354432|Primary|Hot Flash Symptom Severity Score|The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.|12 weeks|All randomized participants were analyzed in a repeated measures mixed model. This allowed inclusion of all study participants.|||percent of baseline score||Standard Error|Least Squares Mean
1270831|NCT00354341|Secondary|Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL||Week 26 up to Week 64|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1282010|NCT00249249|Secondary|Apo-B:Apo-A1 Ratio|Ratio of Apo-B to Apo-A1 at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||ratio||Standard Deviation|Mean
1270832|NCT00354341|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF was calculated as ([LVEDV - LVESV], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV.|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||percentage of LVEDV||Standard Deviation|Mean
1270833|NCT00354341|Secondary|Fractional Myocardial Shortening (FS)|FS was calculated as: ([LVEDD – LVESD] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters [cm]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV.|Baseline, Months 6 and 15|ITT population. Here “n”= participants who were evaluable for each category, for respective arm groups.|||percentage of LVEDV||Standard Deviation|Mean
1270834|NCT00354341|Secondary|Left Ventricular End Diastolic Volume Index (LVEDVI)|LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m^2). LVEDVI was presented in mL/m^2.|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||mL/m^2||Standard Deviation|Mean
1270835|NCT00354341|Secondary|Left Ventricular End Systolic Volume Index (LVESVI)|LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters [mL]) with body surface area (BSA) (in meter square [m^2]). LVESVI is presented in milliliter per meter square (mL/m^2).|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||mL/m^2||Standard Deviation|Mean
1270836|NCT00354341|Primary|Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15|LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 – (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2).|Baseline, Month 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||g/m^2||Standard Deviation|Mean
1270837|NCT00354224|Secondary|Progression-free Survival||Every 6 weeks through study completion for up to about 18 weeks|data was not collected for this endpoint.||||||
1270838|NCT00354224|Secondary|Number of Adverse Events||From the start of study treatment through study completion for up to about 18 weeks||||Serious Adverse Events|||Number
1270839|NCT00354224|Primary|Response Rate as Determined by RECIST.|Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 6 weeks through study completion for up to about 18 weeks|this data was not collected.||||||
1270840|NCT00354172|Secondary|Chimerism After Double Umbilical Cord Blood Transplant (UCBT)|Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient).|Day 21, Day 100, 6 Months|1 Year and 2 Year Post Transplant data was not applicable; no patients reached this timeframe to evaluate.|||Percentage of Engrafted Cells||Full Range|Median
1270841|NCT00354172|Secondary|Number of Participants (Patients) With Successful Natural Killer Cell Expansion|Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population|10-13 Days Post Infusion||||Participants|||Number
1270842|NCT00354172|Secondary|Number of Participants (Patients) Who Experienced Relapse by 24 Months|Number of patients who experienced recurrence or progression of disease from the time of transplant.|2 Years Post transplant||||Participants|||Number
1270843|NCT00354172|Secondary|Number of Participants (Patients) Who Experienced Relapse by 12 Months|Number of patients who experienced recurrence or progression of disease from the time of transplant.|1 Year Post Transplant||||Participants|||Number
1270844|NCT00354172|Secondary|Number of Participants (Patients) Who Died by 24 Months|Number of patients who died after receiving treatment within 24 months post transplant.|2 years post-transplant||||Participants|||Number
1270845|NCT00354172|Secondary|Number of Participants (Patients) Who Died by 12 Months|Number of patients who died after receiving treatment within 12 months post transplant.|1 year Post Transplant||||Participants|||Number
1270846|NCT00354172|Secondary|Number of Participants (Patients) With Chronic Graft-Versus-Host Disease|The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival.|Day 100 through 1 Year Post Transplant||||Participants|||Number
1270847|NCT00354172|Secondary|Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV|Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.|Day 100 post transplant||||Participants|||Number
1270848|NCT00354172|Secondary|Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV|Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.|Day 100 Post Transplant||||Participants|||Number
1270849|NCT00354172|Secondary|Number of Participants (Patients) Who Attained Platelet Engraftment|Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days.|1 Year Post Transplant||||Participants|||Number
1270850|NCT00354172|Secondary|Number of Participants (Patients) Who Attained Neutrophil Engraftment|"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)."|Day 42 Post Transplant||||Participants|||Number
1270851|NCT00354172|Secondary|Number of Participants (Patients) Who Died Due to Transplant.|Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months.|6 Months Post Transplant||||Participants|||Number
1270852|NCT00354172|Secondary|Number of Patients Who Were Disease-free and Alive at 24 Months|Number of patients who were alive and free of disease (malignancy) at 24 months after transplant.|24 Months Post transplant||||Participants|||Number
1270853|NCT00354172|Secondary|Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months|Number of patients who were alive and free of disease (malignancy) at 12 months after transplant.|12 Months Post transplant||||Participants|||Number
1270854|NCT00354172|Primary|Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months|Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.|6 Months Post Transplant|One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group.|||Participants|||Number
1270855|NCT00354159|Secondary|Characterize Arrhythmic Events|The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm|12 months post implant|All 399 subjects successfully implanted with the Chronicle ICD were included in the analysis.|||VT/VF episodes per subject month||95% Confidence Interval|Number
1270856|NCT00354159|Secondary|Characterize Quality of Life at Baseline and 12-month Visit|The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.|baseline to 12 months post implant|Subjects were required to respond to the baseline and 12-month follow-up visit to be included in the analysis.|||scores on a scale||Standard Deviation|Mean
1270857|NCT00354159|Secondary|Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)|The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin|Implant|Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing.|||percentage of subjects||95% Confidence Interval|Number
1270858|NCT00354159|Secondary|Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)|Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.|implant|Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing as part of their ICD implant procedure.|||Percentage of subjects with waveforms||95% Confidence Interval|Number
1270859|NCT00354159|Secondary|Characterize Renal Function at the Baseline and 12-month Visit|Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.|baseline to 12 months post implant|Subjects were required to have creatinine values available at the baseline and 12-month visit to be included in the analysis of this objective.|||mL/min/1.73 m^2||Standard Deviation|Mean
1270860|NCT00354159|Secondary|Characterize Distance Walked in Six Minutes|The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.|baseline to 12 months post implant|Subjects were required to complete the 6-minute hall walk test at both the baseline and 12-month visit to be included in the analysis of this objective.|||distance walked in 6-minutes (meters)||Standard Deviation|Mean
1270861|NCT00354159|Secondary|Characterize NYHA Functional Class|The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.|baseline to 12 months post implant|Subjects were required to have an NYHA functional class assessment at the baseline and 12-month follow-up visit to be included in this analysis.|||percentage of subjects|||Number
1270862|NCT00354159|Secondary|Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events|The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Control Arm subjects with and without a heart failure related event during the 12-month randomized period.|12 months post implant|All Control Arm subjects with at least 90 days of pressure data available during the 12-month randomized follow-up period.|||ePAD mm Hg||Standard Deviation|Mean
1270863|NCT00354159|Secondary|Characterize Intracardiac Pressure|The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.|12 months post implant|At least 90 days of ePAD data were required for each subject during the 12-month randomized period to be included in the analysis.|||ePAD mm Hg||Standard Deviation|Mean
1270866|NCT00354159|Secondary|Characterize Randomized Days Alive Out of Hospital|Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.|12 months post implant|All randomized subjects.|||Days||Standard Deviation|Mean
1270867|NCT00354159|Secondary|Characterize Health Resource Utilization|Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.|12 months post implant|All randomized subjects.|||percentage of randomized days||Full Range|Mean
1270868|NCT00354159|Secondary|Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.|"The definitions of worsened, improved, and unchanged are as follows:~Worsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF.~Improved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score.~Unchanged: Subject is neither worsened nor improved."|12 months post implant|All randomized follow-up from all randomized subjects were included.|||Percent of Subjects|||Number
1270869|NCT00354159|Secondary|Relative Risk of All-cause Events|All-cause events were defined as hospitalizations, hospitalizations <24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.|12 months post-implant|All randomized follow-up from all randomized subjects|||All cause event rate per year||95% Confidence Interval|Mean
1270870|NCT00354159|Secondary|Freedom From All Cause Death or Heart Failure Hospitalization|Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period|12 months post-implant|All randomized subjects|||Number of subjects meeting endpoint|||Number
1270871|NCT00354159|Secondary|Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group|The rate of CV-related events (hospitalizations >24h, hospitalizations <24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.|12 months post-implant|All randomized follow-up for all randomized subjects.|||Cardiovascular related events per year||95% Confidence Interval|Mean
1270872|NCT00354159|Secondary|Cumulative Days in the Hospital for Heart Failure|The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.|12 months post-implant|All follow-up from all randomized subjects were included in this analysis.|||Percent days in hospital||Full Range|Median
1270873|NCT00354159|Primary|Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group|The rate of HF-related events (hospitalizations >24h, hospitalizations <24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.|12 months post-implant|All randomized subjects|||Heart failure related events per year||95% Confidence Interval|Mean
1270874|NCT00354159|Primary|Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant|A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.|6 months post implant|All subjects with an attempted implant of the Chronicle IHM system were included in this analysis. At the time the study stopped, there was only one subject with an attempted Chronicle IHM implant. Thus this objective was not analyzed.|||Percent of Chronicle IHM subjects||Full Range|Mean
1270875|NCT00354159|Primary|Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.|A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.|Within 6 months post-implant|All 406 subjects with an attempted implant of the Chronicle ICD system.|||Percentage of Chronicle ICD Subjects||95% Confidence Interval|Number
1270876|NCT00354107|Secondary|Minimal Residual Disease by Using Southern Blotting or by Real-time Polymerase Chain Reaction (PCR)|NPM-ALK expression will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.|At baseline and weeks 5 and 11|These data were not collected to assess this study aim and will never be collected.||||||
1270877|NCT00354107|Secondary|Development of Human Antichimeric Antibodies by Using ELISA Method|Change in level from baseline to week 11 will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.|Change from baseline to week 11|These data were not collected to assess this study aim and will never be reported.||||||
1270878|NCT00354107|Secondary|CD30 Concentrations Levels as Assessed by ELISA|Summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals. Although the limited sample size precludes formal hypothesis testing, exploratory analysis of the association between soluble CD30 levels and PK parameters and response will be performed.|At baseline|These data were not collected to assess this study aim and will never be reported.||||||
1270879|NCT00354107|Secondary|Pharmacokinetics of Monoclonal Antibody SGN-30 Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Methods||At baseline, at weeks 1, 2, 5, 6, and 11|These data were not collected to assess this study aim and will never be reported.||||||
1271007|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
1270880|NCT00354107|Primary|Response|Anti tumor activity as assessed by computed tomography of neck/chest/abdomen/pelvis, positron emission tomography scan and/or gallium scan. Assessed by physical examination appropriate imaging studies. Bone marrow aspirate/biopsy must be normal and any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Gallium scans must be negative if initially positive.|Week 4||||percent|||Number
1270881|NCT00354029|Primary|NRS Pain = Numeric Rating Scale (0-10)|The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.|24 hours||||Units on a scale||Standard Deviation|Mean
1270882|NCT00353977|Primary|Cellular Immune Response in Vaccine Recipients|Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating cytomegalovirus (CMV)-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors.|Day 45|11 subjects were CMV seropositive and 3 subjects were seronegative.|||participants|||Number
1270883|NCT00353873|Secondary|Number of Participants Who Achieved WC Asthma|WC asthma is defined as two or more of symptom score >1 only allowed on <=2 days/week, rescue salbutamol/albuterol use on <=2 days/week and up to a maximum of 4 times per week, >=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as ‘WC’, ‘Not Controlled’ or ‘Unevaluable’. A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. ‘Unevaluable’ classification included participants with less than 4 wks of data during the assessment period.|Week 5 up to Week 12|ITT Population. Only participants with analyzable data at the indicated time point were assessed.|||Participants|||Number
1270884|NCT00353873|Secondary|Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma|TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, >=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as ‘TC’, ‘Well Controlled’ (WC), ‘Not Controlled’ or ‘Unevaluable’. A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. ‘Unevaluable’ classification included participants with less than 4 wks of data during the assessment period.|Week 5 up to Week 12|ITT Population. Only participants with analyzable data at the indicated time point were assessed.|||Participants|||Number
1270885|NCT00353873|Primary|Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population|PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.|Baseline; Week 1 up to Week 12|PP Population: All participants in the ITT Population who did not have any protocol violations which could impact treatment effect. Only participants with analyzable data at the indicated time point were assessed.|||L/min||Standard Error|Least Squares Mean
1270886|NCT00353873|Primary|Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population|PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.|Baseline; Week 1 up to Week 12|ITT Population: All participants randomized to treatment who received at least one dose of randomized study medication. Only participants with analyzable data at the indicated time point were assessed.|||Liters/Minute (L/min)||Standard Error|Least Squares Mean
1270887|NCT00353834|Secondary|Fourth Will be Changes in Insulin, Glucose, C-peptide, Lipids, and FFA Responses Following the MTT in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurement||Baseline and end of study|||||||
1270888|NCT00353834|Secondary|Third Will be the Changes in Markers of Endothelial Function, Inflammation, Fibrinolysis, and Oxidative Stress in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline||Baseline and end of study|||||||
1270889|NCT00353834|Secondary|Second Will be the Change in Arterial Stiffness, as Measured by PWA, in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements.||Baseline and end of study|||||||
1270890|NCT00353834|Secondary|First Will be the Changes in TNG Stimulated Arterial Dilation (Endothelial-independent) in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements|Trinitroglycerin (TNG) response evaluates endothelium independent vasodilation. The brachial artery was scanned before and 5 minutes after sublingual administration of 400 ug of trinitroglycerin. This was performed only at 4 hours following the test meal and fifteen minutes after completion of the FMD study to allow for the brachial artery to return to baseline. This was performed at both the baseline and 3 month visits.|Baseline and end of study||||Percentage dilation||Standard Deviation|Mean
1270891|NCT00353834|Primary|The Primary Endpoint Was the Change in FMD at the End of the Study Compared to Baseline Measurements in Subjects Treated With Exenatide Compared to Subjects Treated With Lantus.|Flow mediated dilation (FMD) of the brachial artery was measured at rest and during reactive hyperemia using a high-resolution 10.0 MHz linear array transducer and an HOI Ultramark 9 system. Reactive hyperemia was produced by inflating a pneumatic tourniquet on the forearm distal to the brachial artery to 50 mmHg above the systolic BP for 5 minutes, then deflating it . Brachial artery diameter was measured before inflation of the cuff and 1-2 minutes after cuff deflation and expressed as the percentage change. This protocol is described in detail elsewhere. This was performed fasting, 2, and 4 hours after the meal challenge at baseline and 3 months.|Baseline and End of Study||||Percentage dilation||Standard Deviation|Mean
1270892|NCT00353795|Primary|Mean Coronary Wall Thickness|Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).|n/a (cross sectional analysis)||||mm||Standard Deviation|Mean
1270893|NCT00353704|Secondary|Morphine (Opioid) Consumption Cumulated|"Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as  cumulated opioid consumption (milligram)"|240 minutes||||mg||Standard Deviation|Mean
1270894|NCT00353704|Primary|Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)|The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.|120 minutes after surgery||||Units on a scale||Standard Deviation|Mean
1270895|NCT00353652|Secondary|Body Weight||Measured at 6 months|||||||
1270896|NCT00353652|Secondary|Electrolytes||Measured at 6 months|||||||
1270897|NCT00353652|Primary|Inflammatory Cytokines||Measured at 6 months|||||||
1270898|NCT00353652|Primary|C-reactive Protein||Measured at 6 months|||||||
1270899|NCT00353652|Primary|Baroreflex Sensitivity||Measured at 6 months|||||||
1270900|NCT00353652|Primary|Forearm Blood Flow||Measured at 6 months|||||||
1270901|NCT00353652|Primary|Insulin Sensitivity||Measured at 6 months|||||||
1270902|NCT00353652|Primary|24-hour Ambulatory Blood Pressure||Measured at 6 months|||||||
1270903|NCT00353652|Primary|Sympathetic Nerve Activity||Measured at 6 months||||bursts/min||Standard Deviation|Mean
1270904|NCT00353496|Secondary|Percentage of Patients Still Alive Based on Available Overall Survival Data|Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.|Randomisation to death or last visit, up to 321 weeks|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.|||percentage of participants|||Number
1270905|NCT00353496|Secondary|Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels||Week 12 to Week 96 (last visit)|Analysis based on the subgroup of subjects with an elevated plasma CgA values. Subjects with a gastrinoma were excluded from the analysis.|||percentage of participants|||Number
1270906|NCT00353496|Secondary|Change in the Global Health Status Quality of Life Assessment|Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.|Week 12 to Week 96 (last visit)|Analysis based on the intent-to-treat (ITT) population which comprised 193 randomised subjects with valid assessment.|||score on a scale||Standard Error|Least Squares Mean
1270907|NCT00353496|Secondary|Pharmacokinetic Profile of Lanreotide|Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints|Week 4, 12, 24, 36, 48, 72, 96|Analysis based on the intent-to-treat (ITT) population which comprised 101 randomised subjects who received lanreotide|||ng/mL||Standard Deviation|Mean
1270908|NCT00353496|Secondary|Percentage of Patients Alive & Without Disease Progression|Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.|Week 48 & 96|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.|||Percentage of participants|||Number
1270909|NCT00353496|Primary|Progression-Free Survival (PFS)|Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0|From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.|||Weeks||95% Confidence Interval|Median
1270910|NCT00353431|Secondary|Frequency of Hypokalaemia|Number of participants with hypokalaemia (potassium < 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)|during observation of 48 hours||||participants|||Number
1270911|NCT00353431|Secondary|Frequency of Severe Hypoglycaemia|Number of participants with severe hypoglycaemia (plasma glucose < 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)|during observation of 48 hours||||participants|||Number
1270912|NCT00353431|Secondary|Frequency of Hypoglycemia|absolute number of participants with hypoglycemia (plasma glucose < 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)|during observation of 48 hours||||participants|||Number
1270913|NCT00353431|Secondary|Time to Reach the Target Range|Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).|24 h|Intension to treat|||hours||Standard Deviation|Mean
1270914|NCT00353431|Primary|Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours|Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)|48 h|Intension to treat|||hours||Standard Deviation|Mean
1270915|NCT00353418|Primary|Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia|Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.|Up to Week 72|The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.|||Percentage of participants|||Number
1270916|NCT00353418|Secondary|Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12|EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.|Week 12|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
1270917|NCT00353418|Secondary|Rapid Virological Response (RVR) by Week 4|RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.|Week 4|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
1270918|NCT00353418|Secondary|Relapse of Virological Response|Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.|Weeks 48 and 72|Within the All Patients Treated population, patients with a response at end of treatment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 37 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 83 patients.|||Percentage of participants|||Number
1270919|NCT00353418|Secondary|Virological Response at Weeks 4, 12 and 24|Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.|Weeks 4, 12 and 24|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
1270920|NCT00353418|Secondary|Virological Response at End of Treatment Period|Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.|Week 48|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
1270921|NCT00353418|Primary|Sustained Virological Response (SVR)|SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.|Week 72|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
1270922|NCT00353366|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that : results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Throughout the study period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.|||Participants|||Number
1270923|NCT00353366|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|Unsolicited Adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During 31 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.|||Subjects|||Number
1270924|NCT00353366|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhea, fever, irritability, loss of appetite and vomiting.|During 15 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort , which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.|||Subjects|||Number
1270925|NCT00353366|Primary|Number of Subjects Reporting Grade 2 or 3. Grade 2 : An AE Which Was Sufficiently Discomforting to Interfere With Normal Everyday Activities. Grade 3: an Unsolicited AE That Prevented Normal Everyday Activity.|Grade 2 or 3 assessed include fever, vomiting and diarrhea|During 15 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.|||Subjects|||Number
1270926|NCT00353301|Secondary|Overall Survival|For all subjects who had not died at the time of statistical analysis, duration of survival will was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the magnitude of the treatment effect as described for progression-free survival.|Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.|Per protocol analysis was used and 25 participants that were enrolled in the study were included in the analysis.|||Weeks||95% Confidence Interval|Median
1270983|NCT00352365|Primary|Complete Response|Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl.|Up to 5 years|Eligible patients who began protocol therapy|||percentage of participants||95% Confidence Interval|Number
1270927|NCT00353301|Primary|Progression-free Survival|Time to progression was defined as the time from beginning of therapy until disease progression or death. For subjects who had not progressed at the time of statistical analysis, progression-free survival was censored at the date of their last tumor assessment. Kaplan-Meier method was used to estimate median progression-free survival. Progression was defined as radiographic progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (year 2000 version), non-compliance in obtaining scans, unequivocal clinical progression or the initiation of another medication for the treatment of renal cell carcinoma.|Physical exam assessments were performed every 4 weeks during the treatment phase. Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.|Per protocol analysis was used and 25 participants that were enrolled in the study were included in the analysis.|||Weeks||95% Confidence Interval|Median
1270928|NCT00353275|Secondary|Hypoglycemia||Duration of hospital stay|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.||||||
1270929|NCT00353275|Secondary|Organ Failure||Duration of hospital stay|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.||||||
1270930|NCT00353275|Primary|Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)||Duration of hospital stay|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.||||||
1270931|NCT00353275|Primary|Infectious Morbidity||Duration of hospital stay, an average of 2 weeks|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.||||||
1270932|NCT00353262|Secondary|Marked Laboratory Abnormalities|Number of participants with marked laboratory abnormalities (hematology, coagulation, liver function, renal function, protein, electrolytes, miscellaneous).|Up to 28 days after last chemotherapy administration|All 36 participants who received at least one dose of capecitabine.|||Participants|||Number
1270933|NCT00353262|Secondary|Number Of Participants With Adverse Events (AEs)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. This includes any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during the study were also to be reported as AEs.|Approximately 3 Years (up to 28 days after the last intake of study medication)|All 36 participants who received at least one dose of capecitabine.|||Participants|||Number
1270934|NCT00353262|Secondary|Clearance of Total And Free Platinum|CL is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (hour).|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||mL/Hr||Geometric Coefficient of Variation|Geometric Mean
1270935|NCT00353262|Secondary|Volume of Distribution at Steady State (VSS) of Total And Free Platinum|VSS is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||mL||Geometric Coefficient of Variation|Geometric Mean
1270936|NCT00353262|Secondary|T1/2 Beta of Total And Free Platinum|T1/2 beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of total and free platinum.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||hour||Geometric Coefficient of Variation|Geometric Mean
1270937|NCT00353262|Secondary|Cmax of Total And Free Platinum|Cmax is defined as maximum observed analyte concentration of Total And Free Platinum.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1270938|NCT00353262|Secondary|AUC0-last of Total And Free Platinum|Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of Total And Free Platinum.|pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL* hr||Geometric Coefficient of Variation|Geometric Mean
1271002|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288||Week 288|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271003|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240||Week 240|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1270939|NCT00353262|Secondary|AUC0-infinity for Total Platinum|AUC0-infinity represents the area under the concentration-time curve of the analyte (total platinum) in plasma over the time interval from 0 extrapolated to infinity.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL* hr||Geometric Coefficient of Variation|Geometric Mean
1270940|NCT00353262|Secondary|Elimination Half-life Period (t1/2 Beta) of Capecitabine and Its Metabolites (5’-DFUR , 5’-DFCR, 5 FU, and FBAL)|t1/2 Beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of capecitabine and its metabolites (5’-DFUR , 5’-DFCR, 5 FU, and FBAL)|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||hour||Geometric Coefficient of Variation|Geometric Mean
1270941|NCT00353262|Secondary|Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Cmax is defined as maximum observed analyte concentration of capecitabine and its metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1270942|NCT00353262|Secondary|AUC0-last of Capecitabine and Its Metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of capecitabine and its metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
1270943|NCT00353262|Secondary|AUC (0-infinity) of Capecitabine and Its Metabolites (5’-DFCR, 5-FU, and FBAL)|AUC0-infinity represents the area under the concentration-time curve of the analytes (5’-DFCR, 5-FU, and FBAL) in plasma over the time interval from 0 extrapolated to infinity. After oral administration, capecitabine is first metabolized in the liver to 5’-deoxy-5-fluorocytidine (5’-DFCR), which is then converted to 5’-DFUR, and then catalytically activated to 5-FU.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
1270944|NCT00353262|Primary|AUC0-inf for Free Platinum|AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity.|Predose , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the 2 hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL * hr||Geometric Coefficient of Variation|Geometric Mean
1270945|NCT00353262|Primary|Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0–Inf) of 5’-Deoxy-5-fluorouridine 5’-(DFUR)|AUC0-infinity represents the area under the concentration-time curve of the analyte (5’-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5’-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL * hr).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
1270946|NCT00353119|Secondary|Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover|"Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|12 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.|||Percentage change||Standard Deviation|Mean
1270947|NCT00353119|Secondary|Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI)|"Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|24 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.|||Percentage change||Standard Deviation|Mean
1271004|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271005|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1270948|NCT00353119|Secondary|Number of Adverse Events|Study the safety of etanercept in patients with PPP by collecting adverse events from the screening visit until week 28. For a given AE, a subject will be counted once even if he or she has experienced multiple episodes for that particular AE. An adverse event is any untoward medical occurrence including any clinically significant abnormal laboratory values or variation from the baseline condition to the last visit (week 28) in a patient receiving a pharmaceutical product, without regards to the possibility of a causal relationship with this treatment.|28 weeks|Patients that crossed over from placebo to etanercept are included in the Etanercept group. The placebo group only included adverse events from the first 12 weeks prior to the crossover. The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.|||Adverse Events|||Number
1270949|NCT00353119|Primary|Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover|"Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 12 weeks in patients treated with placebo or etanercept~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|12 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.|||Percentage change||Standard Deviation|Mean
1270950|NCT00352911|Primary|Mean Log Change in Viral Load From Baseline (Day 1) to Day 56|Mean log change in HIV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment.|Baseline (Day 1) to Day 56||||copies/mL on log scale||Standard Deviation|Log Mean
1270951|NCT00352885|Secondary|Genetic Polymorphisms||Screening and After Cycle 4 (up to 14 weeks)|Genetic polymorphisms were not analyzed due to the small sample size and insufficient funds.||||||
1270952|NCT00352885|Secondary|Hamilton Depression Rating Scale (HAM-D) Score|Hamilton Depression Rating Scale (HAM-D) is a 21-item, observer-rated scale which quantifies the severity of depressive symptoms, including depressed mood, loss of interest in usually pleasurable activities, insomnia, anorexia, fatigue, weight loss, and psychomotor retardation or agitation. Participants rate the severity of their symptoms on a scale of 0-2 or 0-4 (depending on the item), where 0 means that the symptom is absent. Total scores are calculated by summing the first 17 items for a total score between 0 and 50. For this study a score of 0-6 indicates a normal state, a score of 7-17 indicates mild depression, a score of 18-24 indicates moderate depression, and a score of greater than 25 indicates severe depression. The HAM-D was administered at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.|Screening and Cycles 1 - 4 (up to 14 weeks)|The population in this analysis includes participants completing the HAM-D at the indicated study visit. Participants withdrew or were terminated from the study early depending on their ability to continue IL-2 treatment.|||units on a scale||Standard Error|Mean
1270953|NCT00352885|Secondary|Plasma Concentrations of Cortisol|Cortisol is a steroid hormone made in the adrenal glands in response to fear or stressful situations. A typical reference range is 6-23 micrograms/deciliter (mcg/dL) from blood drawn in the morning. Low levels of cortisol can indicate Addison's disease or a problem with the pituitary gland, while high levels may indicate tumors of the adrenal gland, among other illnesses, or increased stress. Chronic elevation of cortisol is associated with reduced immune function and increased risk of heart disease. IL-2 treatment stimulates the release of cortisol and this stimulation is dose dependent (rising as the dose of IL-2 increases) and tends to increase further with repeated exposure to IL-2. Blood was drawn for measuring cortisol at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.|Screening and Cycles 1 - 4 (up to 14 weeks)|The population in this analysis includes participants with cortisol measurements at the indicated study visit. Participants withdrew or were terminated from the study early depending on their ability to continue IL-2 treatment.|||mcg/dL||Standard Error|Mean
1270954|NCT00352885|Secondary|Plasma Concentrations of Interleukin 6 (IL-6)|Immune system functioning was assessed by measuring plasma concentrations of interleukin 6 (IL-6). IL-6 is a proinflammatory cytokine that is elevated during times of inflammation, infection, in patients with advanced or metastatic cancer, and is also implicated in mood disorders. IL-2 treatments are associated with increased IL 6 levels, in a dose response manner. IL-6 values in healthy individuals are generally less than 16 pg/ml. Blood was drawn for measuring IL-6 at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.|Screening and Cycles 1 - 4 (up to 14 weeks)|The population in this analysis includes participants with IL-6 measurements at the indicated study visit. Participants withdrew or were terminated from the study early depending on their ability to continue IL-2 treatment.|||pg/ml||Standard Error|Mean
1270955|NCT00352885|Secondary|Plasma Concentrations of Adrenocorticotropic Hormone (ACTH)|Adrenocorticotropic hormone (ACTH) is a stress hormone that is synthesized by the pituitary in response to corticotropin-releasing hormone (CRH). ACTH stimulates adrenal cortisol production. ACTH levels vary throughout the day and are highest between 6am and 8am. A typical reference range is 10-50 picograms per milliliter (pg/ml) from blood drawn in the morning. Low levels of ACTH can indicate adrenal insufficiency (including adrenal cancers) while high levels may indicate several diseases or stress. IL-2 treatment stimulates the release of ACTH and this stimulation is dose dependent (rising as the dose of IL-2 increases) and tends to increase further with repeated exposure to IL-2. Blood was drawn for measuring ACTH at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.|Screening and Cycles 1 - 4 (up to 14 weeks)|The population in this analysis includes participants with ACTH measurements at the indicated study visit. Participants withdrew or were terminated from the study early depending on their ability to continue IL-2 treatment.|||pg/ml||Standard Error|Mean
1270956|NCT00352885|Primary|Number of IL-2 Treatments Tolerated|The mean number of IL-2 doses tolerated (out of the possible 60 total doses) are presented for each study arm. The standard high dose regimen of IL-2 includes 15 doses per cycle. The dose of IL-2 is reduced, or treatment is stopped entirely, if the side effects become severe. This analysis includes the total number of doses taken at the end of Cycle 4, by all participants who began the trial, regardless of how many cycles each participant completed.|Cycle 4 (up to 12 weeks of IL-2 treatment)||||IL-2 treatments||Standard Deviation|Mean
1270957|NCT00352846|Primary|Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months|The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score >= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores <= -2.5 indicate osteoporosis.|From baseline to 12 Months|BMD data available on 53 evaluable participants upon treatment completion.|||Percentage Change of BMD||Standard Deviation|Mean
1270958|NCT00352781|Secondary|Smoking Cessation|7-day point prevalence of abstinence|12 months after end of treatment|Number of participants who completed the 12m follow-up|||percentage of participants abstinent|||Number
1270959|NCT00352781|Primary|Smoking Cessation|7-day point prevalence of abstinence|6 months after end of treatment|Number of participants that completed the 6m follow-up (i.e. per protocol)|||percentage of participants abstinent|||Number
1270960|NCT00352755|Secondary|Overall Survival||Median follow-up was 32 months||||months||Full Range|Median
1270961|NCT00352755|Secondary|Progression-free Survival||Median follow-up was 32 months||||months||Full Range|Median
1270962|NCT00352755|Secondary|Number of Participants Who Experience Surgical Complications Associated With This Regimen||Median follow-up was 32 months||||participants|||Number
1270963|NCT00352755|Secondary|Progression Rate|-Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Median follow-up was 32 months||||percentage of participants|||Number
1270964|NCT00352755|Primary|Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events||30 days after end of treatment||||participants|||Number
1270965|NCT00352690|Secondary|Incidence and Severity of Radiation-induced Pneumonitis||30 days following completion of treatment (approximately 114 days)|Using CTCAE Version 3.0.|||participants|||Number
1270966|NCT00352690|Primary|Overall Survival (OS)|OS = time from patient registration to death of all causes|Completion of follow-up (follow-up ranged from 3 months to 6 years)|Participants with unknown expiration dates were censored at the date of last clinical contact.|||months||95% Confidence Interval|Median
1270967|NCT00352690|Secondary|Incidence and Severity of Radiation-induced Esophagitis||30 days following completion of treatment (approximately 114 days)|Using CTCAE Version 3.0|||participants|||Number
1270968|NCT00352690|Secondary|Response Rates|Overall best response using RECIST 1.0|4 years||||participants|||Number
1270969|NCT00352690|Secondary|Failure-free Survival (FFS)|The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)|Completion of follow-up (follow-up ranged from 3 months to 6 years)|Participants with unknown event dates were censored at the date of last clinical contact.|||months||95% Confidence Interval|Median
1270970|NCT00352690|Secondary|Failure-free Survival (FFS) Rate|"The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)~Estimated using Kaplan Meier"|6 months|Participants with unknown event dates were censored at the date of last clinical contact.|||percentage of participants|||Number
1270971|NCT00352690|Primary|Overall Survival (OS) Rate|"OS = time from patient registration to death of all causes~Estimated using Kaplan Meier"|6 months|Participants with unknown expiration dates were censored at the date of last clinical contact.|||percentage of participants|||Number
1270972|NCT00352664|Primary|Sedation Mean Scores at 1-Week|Anderson Symptom Assessment Scale (ASAS) was used to measure sedation mean scores (SD) on a 0-10 scale with 0 representing “not drowsy” and 10 representing “worst possible drowsiness.”|Baseline and Day 7|Analysis was intention to treat (ITT), and population analyzed was that treated. Study closed early due to low patient accrual and insufficient supply of drug. No patients were randomized to Placebo Arm.|||Scores on a Scale||Standard Deviation|Mean
1270973|NCT00352612|Primary|Clinical Improvement at the 48-72 Hour Clinical Follow-up|Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement.|48-72 hour clinical follow-up||||participants|||Number
1270974|NCT00352534|Secondary|Incidence of Renal Failure|Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up|During follow-up|Very low risk patients that have metachronous relapse.|||Incidents|||Number
1270975|NCT00352534|Secondary|Incidence of Contralateral Kidney Lesions|Number of contralateral kidney lesions during follow-up.|During follow-up|Very low risk patients treated by nephrectomy and observation only.|||Lesions|||Number
1270976|NCT00352534|Primary|Overall Survival (OS) Probability|Probability of being alive after 4 years in the study.|4 years|Eligible very low risk or standard risk patients|||Probability||95% Confidence Interval|Number
1270977|NCT00352534|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|4 years|Eligible very low risk or standard risk patients|||Probability||95% Confidence Interval|Number
1270978|NCT00352417|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)||Baseline and 12 weeks|Evaluable population with both baseline and visit 8 results|||mg/L||95% Confidence Interval|Least Squares Mean
1270979|NCT00352417|Secondary|Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine||Baseline and 12 Weeks|Evaluable Population|||Percent Change||95% Confidence Interval|Geometric Mean
1270980|NCT00352417|Secondary|Change From Baseline in Whole Blood Leukotriene B4 Production||Baseline and 12 weeks|Evaluable Population|||pg/ml||95% Confidence Interval|Least Squares Mean
1270981|NCT00352417|Secondary|Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue|Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of anti-5-Lipoxygenase staining in plaque tissue|12 weeks|Evaluable Population with histological sections available|||Percent Area||95% Confidence Interval|Mean
1270982|NCT00352417|Primary|Percent Cross-sectional Area of Macrophages in Plaque Tissue|Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody|12 weeks|Evaluable Population with histological sections available|||Percent Area||95% Confidence Interval|Mean
1270984|NCT00352365|Secondary|Total Response|Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.|Up to 5 years|Eligible patients who began protocol therapy|||percentage of participants||95% Confidence Interval|Number
1270985|NCT00352365|Secondary|Cytogenetic Abnormalities|Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.|Up to 5 years||||Number of abnormalities||Full Range|Median
1270986|NCT00352365|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1270987|NCT00352118|Secondary|Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire|All patients were non-evaluable and study was terminated early. There is no measure of outcome.|baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
1270988|NCT00352118|Secondary|Swallowing Ability - Quality of Life Scores|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).|Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
1270989|NCT00352118|Secondary|Time to Treatment Failure|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.|Number of Days from Complete or Partial Response to First Date of Recurrence or Progression|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
1270990|NCT00352118|Secondary|Number of Days With Disease Free Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.|From Date of Registration to Date of First Treatment Failure or Death|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
1270991|NCT00352118|Secondary|Number of Days - Overall Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.|Between date of registration to date of death.|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
1270992|NCT00352118|Secondary|Number of Days With Progression-free Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.|Between date of registration to date of first treatment failure or death.|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
1270993|NCT00352118|Primary|Number of Patients With Feeding Tube Dependency|All patients were non-evaluable and study was terminated early. There is no measure of outcome.|at 12 months|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
1270994|NCT00352105|Primary|Number of Participants With No Distant Metastatic Disease at 1 Year|1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.|1 year|5 early deaths were not evaluable|||participants|||Number
1270995|NCT00352105|Secondary|Number of Participants Who Completed 2 Years of Therapy||at 2 years after start of treatment||||participants|||Number
1270996|NCT00352105|Secondary|Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.|Complete response rate per RECIST Criteria (CTC V3)|3 years|5 early deaths were not evaluable|||participants|||Number
1270997|NCT00352105|Secondary|Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity|Any toxicity greater than or equal to Grade 1= mild|at 1 year after start of treatment||||participants|||Number
1270998|NCT00352105|Secondary|Number of Participants With No Local Disease at 1 Year|Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.|at 1 year after start of treatment|5 early deaths not evaluable|||participants|||Number
1270999|NCT00352105|Primary|Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival|To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival|at 1 year after start of treatment||||participants|||Number
1271000|NCT00352053|Secondary|Percentage of Participants With Virologic Failure Through Week 48|"Virologic failure was defined as either nonresponse or viral rebound.~Nonresponse (failure to achieve response). Response was defined as either~A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or~HIV-1 RNA < 400 copies/mL at 2 consecutive visits.~Viral rebound was defined as either~Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or~Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.~The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase."|Up to 48 weeks|ITT Analysis Set. 1 participant without time to respond [6 days of treatment]) was excluded. Nonresponders were counted as failures at time 0. Rebounders were counted as failures on study day of the first of 2 assessments meeting criteria. Otherwise, they were censored at last double-blind HIV measurement.|||Kaplan-Meier percentage|||Number
1271001|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Week 336|ITT Analysis Set, missing = excluded method||||||
1271008|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24||Week 24|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
1271009|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Week 336|ITT Analysis Set, missing = excluded method||||||
1271010|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288||Week 288|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271011|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240||Week 240|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271012|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192||Week 192|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271013|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144||Week 144|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271014|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96||Week 96|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271015|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48||Week 48|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
1271016|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24||Week 24|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
1271017|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method||||||
1271018|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271019|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271020|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271021|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271022|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
1271023|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48||Baseline to 48 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
1271024|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24||Baseline to 24 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
1271025|NCT00352053|Secondary|Change From Baseline to Week 336 in CD4 Percentage|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method||||||
1271026|NCT00352053|Secondary|Change From Baseline to Week 288 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 288 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
1271027|NCT00352053|Secondary|Change From Baseline to Week 240 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 240 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
1271028|NCT00352053|Secondary|Change From Baseline to Week 192 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 192 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
1271029|NCT00352053|Secondary|Change From Baseline to Week 144 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 144 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
1271030|NCT00352053|Secondary|Change From Baseline to Week 96 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 96 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
1271031|NCT00352053|Secondary|Change From Baseline to Week 48 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 48 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
1271032|NCT00352053|Secondary|Change From Baseline to Week 24 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 24 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
1271033|NCT00352053|Secondary|Change From Baseline to Week 336 in CD4 Count|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method||||||
1271048|NCT00352053|Secondary|Change From Baseline to Week 24 in HIV-1 RNA||Baseline to 24 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the last observation carried forward (LOCF) method (includes the participant’s last available postbaseline value for missing data). The Placebo/TDF groups were analyzed using the missing = excluded method (participants with missing data were excluded from the analysis).|||log10 copies/mL||Inter-Quartile Range|Median
1271049|NCT00352053|Secondary|Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA|"DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed)."|Baseline to 48 weeks|ITT Analysis Set|||log10 copies/mL||Inter-Quartile Range|Median
1271050|NCT00352053|Primary|Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA|"DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed)."|Baseline to 24 Weeks|Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least 1 dose of study drug, with baseline HIV-1 RNA ≥ 1000 copies/mL and who had no major eligibility criteria violations.|||log10 copies/mL||Inter-Quartile Range|Median
1271051|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Stage|Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage <III showed a better outcome but was not statistically significant.|5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up||||events|||Number
1271052|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Histology|Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.|3 years follow-up||||events|||Number
1271053|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Gender|Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.|3 years follow-up||||events|||Number
1271054|NCT00352027|Secondary|Toxicities With Grade >1|Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|3 years|Toxicities reported below for the current study (HOD05) include all reported toxicities from a participant's on-study date through 2/17/2016. Toxicities reported below for the HOD99 study include all those reported from a participant's on-study date through their off-study date.|||adverse events|||Number
1271055|NCT00352027|Secondary|3-year Local Failure-free Survival Probability|Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3 years||||probability||95% Confidence Interval|Number
1271056|NCT00352027|Secondary|3-year Overall Survival (OS) Probability|Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3-years||||probability||95% Confidence Interval|Number
1271057|NCT00352027|Secondary|3-year Event-free Survival (EFS) Probability|Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3 years||||probability||95% Confidence Interval|Number
1271058|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271066|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271059|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271060|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271061|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271062|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271063|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271064|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271065|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271135|NCT00351936|Primary|Change From Baseline in Fasting Total Cholesterol|Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||mg/dL||Standard Deviation|Mean
1271067|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271068|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271069|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271070|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271071|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271072|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
1271073|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271089|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271074|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271075|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271076|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271077|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271078|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271079|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271080|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271136|NCT00351936|Primary|Change From Baseline in Waist-hip Ratio (WHR)|Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||cm||Standard Deviation|Mean
1271081|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271082|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271083|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271084|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271085|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271086|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271087|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271088|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271090|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271091|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271092|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271093|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271094|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271095|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271096|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271097|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271098|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271137|NCT00351936|Primary|Change From Baseline in Body Mass Index (BMI)|Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||kg/m^2||Standard Deviation|Mean
1271099|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271100|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271101|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271102|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271103|NCT00352027|Secondary|Patient Quality of Life (QoL), Symptom Distress Scale|"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.~Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271104|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Communication|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271105|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271106|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271107|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Worry|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271131|NCT00352001|Primary|PHASE I: Maximum Tolerated Dose of Azacitidine|Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard “3+3” design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here.|After 1 courses (1 months)|Participants in Phase I|||mg/m2 subcutaneously for 5 days|||Number
1271108|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271109|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271110|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Nausea|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271111|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271112|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Total Score|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271113|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271114|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271115|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271116|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271132|NCT00351936|Primary|Change From Baseline in Triglycerides|Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||mg/dL||Standard Deviation|Mean
1271117|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271118|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Total Score|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
1271119|NCT00352027|Secondary|Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy||1, 2, 5, and 10 years post therapy|||||||
1271120|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Age|Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.|5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up||||events|||Number
1271121|NCT00352027|Secondary|Local and Distant Failure for Children Treated With Tailored-field Radiation|The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.|from first enrollment date up to 3 years follow-up||||probability that the event occurs||95% Confidence Interval|Number
1271122|NCT00352027|Secondary|Disease Failure Rate Within Radiation Fields|Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).|3 years||||proportion of participants||95% Confidence Interval|Number
1271123|NCT00352027|Primary|3-year Event-Free Survival Probability|The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.|3 years||||probability||95% Confidence Interval|Number
1271124|NCT00352001|Secondary|Overall Survival Among Patients With Complete Response|Time (in months) patients who achieved a complete response using the RECIST criteria were alive on study|After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months|Only patients with complete response|||months||Full Range|Median
1271125|NCT00352001|Primary|PHASE I: Maximum Tolerated Dose of Lenalidomide|Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard “3+3” design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here.|After 1 courses (1 months)|Participants in Phase I|||mg orally for 21 days|||Number
1271126|NCT00352001|Secondary|Number of Patients That Experience Grade 3 or 4 Treatment Related Non-hematologic Adverse Events||After 7 months|Intention to Treat|||participants|||Number
1271127|NCT00352001|Secondary|Time to Relapse After Achieving Complete Response||After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months|Only patients with a complete response were analysed|||months||Full Range|Median
1271128|NCT00352001|Secondary|Time to Transformation to Acute Myeloid Leukemia or Death|Time (in months) patients took to evolve to myeloid leukemia or death after achieving a complete response using the RECIST criteria|After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months|Patients who achieved a complete response|||months||Full Range|Median
1271129|NCT00352001|Primary|PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)|"For the Phase II study portion, to determine the efficacy (measured as response rate) of the combination therapy as defined by the International Working Group (IWG) criteria (CR, complete remission; PR, partial remission; or HI, hematological improvement)~Complete response (CR) is defined as: Disappearance of the chromosomal abnormality without appearance of new ones.~Partial response (PR) is defined as: At least 50% reduction of the chromosomal abnormality.~Hematologic Improvement (HI) is defined as: red blood cell increase of >=1.5g/dL, a platelet response of >=30X10^9/L or by at least 100% for values starting <20X10^9/L, or a neutrophil response of at least 100% and absolute increase of >0.5X10^9/L"|After 7 courses (months)|Intention to Treat|||participants|||Number
1271130|NCT00352001|Primary|PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)|"For the Phase II study portion, to determine the efficacy (measured as response rate) of the combination therapy as defined by the International Working Group (IWG) criteria (CR, complete remission; PR, partial remission; or HI, hematological improvement.~Complete response (CR) is defined as: Disappearance of the chromosomal abnormality without appearance of new ones.~Partial response (PR) is defined as: At least 50% reduction of the chromosomal abnormality.~Hematologic Improvement (HI) is defined as: red blood cell increase of >=1.5g/dL, a platelet response of >=30X10^9/L or by at least 100% for values starting <20X10^9/L, or a neutrophil response of at least 100% and absolute increase of >0.5X10^9/L"|After 4 courses (4 months)|Intention to Treat|||participants|||Number
1271133|NCT00351936|Primary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||mg/dL||Standard Deviation|Mean
1271139|NCT00351819|Other Pre-specified|Insomnia Severity Index (ISI) at Week 14|ISI is comprised of 7 items assesses a participant's perception of insomnia. Each item is rated on a 5-point scale from 0 (none) to 4 (very severe). Scores from the questions are summed to assign a total score ranging from 0 to 28, where higher score represents worse insomnia problem.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
1271140|NCT00351819|Other Pre-specified|C-reactive Protein (CRP) at Week 14|High-sensitivity C-reactive protein (Alpco Diagnostics) was measured using a high-sensitivity sandwich ELISA with an intra-assay CV of 5.6%|Week 14 after intervention|All available data expressed as absolute values at week 14.|||mg/L||Standard Deviation|Mean
1271141|NCT00351819|Other Pre-specified|Leptin at Week 14|Leptin levels were measured using ELISA with an interassay CV of 2.6% to 6.2% and in intra-assay CV of 2.6% to 4.6% (Millipore, Billerica, MA, USA).|Week 14 after intervention|All available data expressed as absolute values at week 14.|||ug/L||Standard Deviation|Mean
1271142|NCT00351819|Other Pre-specified|Adiponectin at Week 14|Total adiponectin was measured using an RIA kit with an interassay CV of 6.9-9.3% and an intra-assay CV of 1.8-6.2% (Millipore).|Week 14 after intervention|All available data expressed as absolute values at week 14.|||ug/mL||Standard Deviation|Mean
1271143|NCT00351819|Other Pre-specified|HOMA IR Score at Week 14|Insulin resistance was calculated using the homeostatic model assessment (HOMA) index: glucose * insulin / 22.5.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||HOMA IR score||Standard Deviation|Mean
1271144|NCT00351819|Other Pre-specified|Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14|All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The insulin level were analyzed at baseline and at 60 and 120 min after glucose loading.|Values at week 14 after intervention|All available data expressed as absolute values at week 14.|||pmol/L||Standard Deviation|Mean
1271145|NCT00351819|Other Pre-specified|Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14|All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The plasma glucose level were analyzed at baseline and at 60 and 120 min after glucose loading.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||mmol/L||Standard Deviation|Mean
1271146|NCT00351819|Other Pre-specified|HbA1c at Week 14||Week 14 after intervention|All available data expressed as absolute values at week 14.|||percentage of glycosylated hemogobin||Standard Deviation|Mean
1271147|NCT00351819|Other Pre-specified|Lipid Profile at Week 14|Serum total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol levels were measured by enzymatic assays and standardized to the CDC using the Lipid Research Clinic protocol. Low-density lipoprotein (LDL) cholesterol was calculated using the Friedewald equation.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||mmol/L||Standard Deviation|Mean
1271148|NCT00351819|Other Pre-specified|Body Composition at Week 14|Body composition was measured using dual-energy X-ray absorptiometry scan.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||kg||Standard Deviation|Mean
1271149|NCT00351819|Other Pre-specified|Inflammatory Cytokines at Week 14|The pathophysiology of pain is measured by the proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-Alpha).|Week 14 after intervention|All available data expressed as absolute values at week 14.|||pg/mL||Standard Deviation|Mean
1271150|NCT00351819|Other Pre-specified|Luteinizing Hormone Values at Week 14|Luteinizing hormone was measured using immunofluorometric assays, with limits of quantification of 0.05 U/L.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||U/L||Standard Deviation|Mean
1271151|NCT00351819|Other Pre-specified|Sex Hormone Binding Globulin (SHBG) at Week 14|Sex hormone binding globulin was measured using immunofluorometric assays, with limits of quantification of 2.5 nmol/L.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||nmol/L||Standard Deviation|Mean
1271152|NCT00351819|Other Pre-specified|Free Testosterone Values at Week 14|Free testosterone was calculated using a law of mass action equation.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||pg/mL||Standard Deviation|Mean
1271153|NCT00351819|Other Pre-specified|Total Testosterone Values at Week 14|Total testosterone was measured in a CDC-certified laboratory using an LC-MS/MS method with a sensitivity of 2 ng/dL.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||ng/dL||Standard Deviation|Mean
1271154|NCT00351819|Secondary|Pain Catastrophizing Scale (PCS) at Week 14|PCS questionnaire measures self-assessment of pain catastrophizing. This questionnaire consists of 13 items on past painful experiences and rate on 5-point scales ranging from 0 (not at all) to 4 (all the time). The PCS yields three subscale scores assessing rumination (range 0-16), magnification (range 0-12), helplessness (range 0-24), and a composite score (sum of three domains, ranging 0-52). Higher score represents worse painful experiences.|Values at week 14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
1271155|NCT00351819|Secondary|Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14|The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
1271156|NCT00351819|Secondary|Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.|Week14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
1271220|NCT00351299|Secondary|Length of Intensive Care Unit (ICU) Stay|Number of days intensive care unit (ICU) stay|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end||||days||Inter-Quartile Range|Median
1271157|NCT00351819|Primary|Ice Water-induced Cold Pain and Its After-sensation at Week 14|Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain.|Week 14 after intervention||||seconds||Standard Deviation|Mean
1271158|NCT00351819|Primary|Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14|Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain.|Week 14 after intervention||||watts||Standard Deviation|Mean
1271159|NCT00351819|Primary|Algometer-induced Pressure Pain at Week 14|A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain.|Week 14 after intervention||||kPa/cm2||Standard Deviation|Mean
1271160|NCT00351819|Primary|Brief Pain Inventory (BPI) at Week 14|BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain).|Week14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
1271161|NCT00351741|Secondary|Ventilator Associated Tracheobronchitis (VATB)|Defined as carinal or mainstem airway friability and sloughing with associated bleeding. Only diagnosed after the patient had spent at least 7 days on the assigned ventilator mode and had not been diagnosed with inhalation injury on admission|checked daily||||Participants|||Number
1271162|NCT00351741|Secondary|Barotrauma|Defined as a new pneumothorax, pneumomediastinum, subcutaneous emphysema, interstitial emphysema, or pneumatocele >2 cm in diameter not associated with a vascular procedure, lung biopsy, or thoracentesis.|28 days||||Participants|||Number
1271163|NCT00351741|Secondary|Need for Rescue Ventilator|Subjects who did not meet predetermined oxygenation and ventilation goals on the study mode despite ventilator- specific optimization were switched to a rescue mode of ventilation.|28 days||||Participants|||Number
1271164|NCT00351741|Secondary|Ventilator Associated Pneumonia|Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.|28 days||||Participants|||Number
1271165|NCT00351741|Secondary|Death|In-hospital death.|during hospitalization||||Participants|||Number
1271166|NCT00351741|Secondary|Days Free From Nonpulmonary Organ Failure|days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.|28||||Days||Standard Deviation|Mean
1271167|NCT00351741|Primary|Ventilator-free Days During the First 28 Days|The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs.|28 days||||Days||Standard Deviation|Mean
1271168|NCT00351533|Secondary|Change in Plasma vonWillebrand Factor|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271169|NCT00351533|Secondary|Change in Plasma Surfactant Protein D|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271170|NCT00351533|Secondary|Change in Plasma Interleukin-6|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271171|NCT00351533|Secondary|Change in Plasma Leukotriene B4|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271172|NCT00351533|Secondary|Change in Plasma Interleukin-8|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271173|NCT00351533|Secondary|Change in BALF Neutrophil Count|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||# of cells/mm^3||Inter-Quartile Range|Median
1271174|NCT00351533|Secondary|Change in BALF Monocyte Chemotactic Protein-1|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271175|NCT00351533|Secondary|Change in BALF Interleukin-6|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271176|NCT00351533|Secondary|Change in BALF Leukotriene B4|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271177|NCT00351533|Secondary|Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
1271178|NCT00351533|Secondary|60-day Mortality||60 days from day of enrollment into study||||Participants|||Number
1271179|NCT00351533|Secondary|Hospital Mortality||At end of hospitalization||||Participants|||Number
1271180|NCT00351533|Secondary|Hospital Length of Stay||At end of hospital admission||||Days||Standard Deviation|Mean
1271181|NCT00351533|Secondary|ICU-free Days During First 28 Days After Study Enrollment|ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.|28 days||||Days||Standard Deviation|Mean
1271182|NCT00351533|Secondary|Ventilator-free Days During First 28 Days After Study Enrollment|Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.|28 days||||Days||Standard Deviation|Mean
1271183|NCT00351533|Secondary|Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment|"Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients.~Minimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs."|Throughout hospital stay||||Scores on a scale||Standard Deviation|Mean
1271184|NCT00351533|Secondary|Change in Plasma vonWillebrand Factor|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
1271185|NCT00351533|Secondary|Change in Plasma Surfactant Protein D|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
1271186|NCT00351533|Secondary|Change in Plasma Interleukin-6|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
1271187|NCT00351533|Secondary|Change in Plasma Leukotriene B4|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
1271188|NCT00351533|Secondary|Change in Plasma Interleukin-8|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
1271189|NCT00351533|Secondary|Oxygenation|PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.|Day 5||||PaO2/FiO2||Standard Deviation|Mean
1271190|NCT00351533|Secondary|Static Lung Compliance|30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.|Day 5||||L/cm H20||Standard Deviation|Mean
1271191|NCT00351533|Secondary|Change in BALF Neutrophil Count|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||# of cells/mm^3||Inter-Quartile Range|Median
1271192|NCT00351533|Secondary|Change in BALF Monocyte Chemotactic Protein-1|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
1271193|NCT00351533|Secondary|Change in BALF Interleukin-6|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
1271194|NCT00351533|Secondary|Change in BALF Leukotriene B4|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
1271195|NCT00351533|Primary|Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|The primary outcome was >=50% reduction in BALF IL-8, measured as the change from baseline to day 5. With α=0.05 and β=0.2, we calculated that 26 patients per group were needed if participants underwent two BALs. Analysis was intention to treat (ITT).|||pg/mL||Inter-Quartile Range|Median
1271205|NCT00351468|Secondary|Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication|"Subjects who achieved maximum platelet count at least once during treatment. All platelet counts after an on-study splenectomy are not classed as responses.~Platelet counts within 7 days after a platelet transfusion are not classed as responses.~Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses."|Baseline up to 2 years|ITT population|||Participants|||Number
1271196|NCT00351468|Secondary|Best Post-Baseline Change in the FACT-TH6 at Any Time Point Compared to Baseline|The FACT-TH6 consists of 6 questions in which patients rate (0-4) their general degree of worry related to bleeding and bruising, and resulting activity impairment and frustration. Although the six items do not constitute a formal domain or subscale of the FACT‑Th assessment tool, these items had been identified by focus groups of patients with chronic ITP as important indicators of their HRQoL. Items were reverse-scored as necessary such that higher scores represent higher HRQoL. Total scores ranged from 0 to 24. Recall period is not specified. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years||||Points on a scale||95% Confidence Interval|Mean
1271197|NCT00351468|Secondary|Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score From Any Time Point Compared to Baseline|"The FACIT-Fatigue consists of 13 questions in which patients rate the frequency (0-4) of symptoms of fatigue, in terms of tiredness, weakness, and fatigue Items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 52.Using anchor-based estimates, the minimally important difference in this subscale is 3.0 points.~Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group"|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years|ITT|||Points on a scale||95% Confidence Interval|Mean
1271198|NCT00351468|Secondary|Best Post-Baseline Change in the Short Form of the Motivation and Energy Scale (MEI-SF) From Any Time Point Compared With Baseline|The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy, and social motivation, either as symptoms of chronic ITP or as a side effect of pharmacotherapy. Minimal clinically important differences are estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 108 points. Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years||||Points on a scale||95% Confidence Interval|Mean
1271199|NCT00351468|Secondary|Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline|The SF-36v2 assessment tool was used to obtain information about subjects’ general health status and health-related quality of life. Until a formal assessment of minimal clinically important differences (MCID) is performed, changes from baseline of more than 0.5 standard deviations are suggested as clinically meaningful. Scores were transformed to a 0-100 point scale, with higher scores representing more positive answers. Scores were normalized to have a mean of 50 and SD of 10 to allow for comparison with outcomes from other chronic diseases. Recall period is the past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years||||Points on a scale||95% Confidence Interval|Mean
1271200|NCT00351468|Secondary|Maximum ITP Bleeding Score at Any Time During the Study During All Stages.|The ITP bleeding score is a tool which has been designed specifically to assess the bruising and bleeding in patients with ITP across body sites, ranging from mild to severe. The WHO Grades were dichotomized into the following categories: - Grade 0, No bleeding -Grade 1 to 4, Any bleeding -Grade 0 to 1: No clinically significant bleeding -Grade 2 to 4 Clinically significant bleeding|Baseline up to 2 years||||Participants|||Number
1271201|NCT00351468|Secondary|Number of Subjects Who Required Rescue Therapy During Treatment With Eltrombopag.|Rescue treatment is defined as a composite of: new ITP medication, increased dose of a concomitant ITP medication, platelet transfusion, and splenectomy. Subjects may have received more than 1 type of rescue therapy|Baseline up to 2 years||||Participants|||Number
1271202|NCT00351468|Secondary|Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.|Sustain reduct: Sustained reduction 1 Denominator is number of subjects taking an ITP medication at baseline. 2 Denominator is number of subjects with a sustained reduction. Note: Sustained reduction defined as reduction from baseline in dose and/or frequency which is maintained for at least 4 weeks. Excludes sustained reductions started more than 1 day after last dose.|Baseline up to 2 years||||Participants|||Number
1271203|NCT00351468|Secondary|Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL|Responder in TRA100773: Platelet count 50 Gi/L and 2 x baseline (BL) at last on-treatment assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL), 50 Gi/L, and 30 Gi/L at any time. Responder in RAISE: Platelet count 50GI/L and 2 x baseline at Week 6 assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline, 50 Gi/L, and 30 Gi/L at any time. Responder in REPEAT: Platelet count 50 GI/L and 2 x baseline (BL) at Week 6 assessment in Cycle 1. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL) 50 Gi/L, and 30 Gi/L at any time.|Baseline up to 2 years|ITT|||Participants|||Number
1271204|NCT00351468|Secondary|Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication|"If a subject has more than 1 platelet count result within a week, the lowest value observed is used to determine response. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses.~Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses."|Baseline up to Year 7/Week 364|ITT population|||Participants|||Number
1271206|NCT00351468|Primary|Overall Summary of On-Therapy Adverse Events (Safety Population)|All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.|Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364||||Participants|||Number
1271207|NCT00351416|Primary|FSH Level|Difference in FSH peak following letrozole administration compared with control cycle|EFP: average of menstrual cycle day 6 in the EFP; LFP: average of 2 days after follicle size of 16 mm||||IU/L||Standard Error|Mean
1271208|NCT00351377|Secondary|Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient|"Assessed using the Overall Treatment Effects for health-related quality of life questionnaire. Possible answers were: Improved, about the same, or worse. The questionnaire was completed by the patient."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.|||Participants|||Number
1271209|NCT00351377|Secondary|Overall Treatment Effects for GI Symptoms Assessed by the Patient|"Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: Has there been any change in the participant’s GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms. The possible answers were: Improved, about the same, or worse. The questionnaire was completed by the patient."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.|||Participants|||Number
1271210|NCT00351377|Secondary|Overall Treatment Effects for GI Symptoms Assessed by the Physician|"Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: Has there been any change in the participant’s GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms. The possible answers were: Improved, about the same, or worse. The questionnaire was completed by the physician."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.|||Participants|||Number
1271211|NCT00351377|Secondary|Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium|The change from baseline to the 6-8 week visit for each of the six subscores (each ranging from 0-5) of the PGWB were analyzed individually. Each of the subscores was transformed to fit a range from 0-100. Lower scores indicate more unfavorable conditions, so an increase in score indicates an improvement in symptoms.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
1271212|NCT00351377|Secondary|Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium|The PGWB consists of 22 single items (each ranging from 0-5) with 7 dimensions (including the total score) to be calculated. Lower scores indicate more unfavorable conditions. The total raw score is calculated by summing up all of the single items and thus has a hypothetical range from 0-110 score points. This raw score is further transformed using the formula: (raw score / 110) x 100 to fit a range from 0-100.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
1271213|NCT00351377|Secondary|Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium|The 5 different subscales of the GI-related Quality of Life (GIQLI) were analyzed separately by calculating the average value of the items that were included in the respective subscore. Thus, the theoretical range for each of the subscores was the same as for the single items, i.e. 0-4 score points. An increase in the subscale score indicates an improvement in symptoms.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
1271214|NCT00351377|Secondary|Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium|Assessed by changes in the Gastrointestinal Quality of Life Index (GIQLI) from Baseline visit to the 6-8 week visit. The GIQLI is a 36-item questionnaire and consists of 5 different subscales. The total score was calculated as the sum of the 36 single items which each ranged from 0-4, leading to a hypothetical range from 0-144 score points (lower scores indicate more unfavorable conditions). The mean change was calculated as (6-8 week visit value) minus (Baseline value).|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
1271215|NCT00351377|Secondary|Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium|Changes in GI symptom severity was measured by changes in the total scores of 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline visit to the visit at 6-8 weeks. The GSRS is a 15-item instrument with a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
1271216|NCT00351377|Primary|Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)|Changes in GI symptom severity was measured by changes in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline visit to the visit at 6-8 weeks. This total score was calculated as the average of the 15 single items (each ranging from 1-7 score points) and thus also had a range from 1-7 score points. Higher values indicate more unfavorable conditions.|Baseline and 6 - 8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
1271217|NCT00351351|Primary|Kidney Stone Clearance Rate|stone clearance rate calculated in mm^2/min per protocol specification|6 months|Sample size calculations were performed using a two-sided Student’s t-test with a power of 90% and a significance level of α = 0.05|||mm^2/min||Full Range|Mean
1271218|NCT00351299|Secondary|In-hospital Mortality|Did patient die while in the hospital? (Yes/No)|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end||||Participants|||Count of Participants
1271219|NCT00351299|Secondary|Ease of Management for the Nursing Staff|"Subjective measure rating 3 categories for ease of management:~Mostly easy~Easy to manage 75% of the time~Not easy to manage"|Up to initial 48 hours||||Participants|||Count of Participants
1271222|NCT00351299|Primary|Resolution of Delirium|"Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments.~The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking."|Up to 7 days||||Participants|||Count of Participants
1271223|NCT00351273|Secondary|78 Tender Joint Count (TJC)|Comparison of modified 78 Tender Joint Count (TJC) between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of tender joing in each of the 78 joints was determined by examination. Each tender joint receives a value of 1, ranging from 0-78 as a possible score.|Baseline, Month 1, 3, 6 and 9||||Tender Joints||Full Range|Mean
1271224|NCT00351273|Secondary|Swollen 76 Joint Count (SJC)|Comparison of modified Swollen Joint Counts between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of swelling in each of the 76 joints was determined by any swelling or absence of swelling. Each swollen joint receives a value of 1, ranging from 0-76 as a possible score.|Baseline, month 1,3,6 and 9||||Swollen Joints||Full Range|Mean
1271225|NCT00351273|Secondary|PhGA Assessment|Comparison of Physician's global assessment of disease activity (PhGA) using 0-100mm visual analog scale (VAS) , where 0 indicates the best possible outcome and 100 indicates the worst possible outcome, in combination antibiotic vs placebo groups at Baseline, month 1,3,6 and 9|Baseline, month 1,3,6 and 9||||units on a scale||Full Range|Mean
1271226|NCT00351273|Secondary|HAQ DI Score|"Comparison of HAQ-DI score of combination antibiotic group vs placebo group at Baseline, Month 1,3,6 and 9 The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The questionnaire is a patient reported outcome (PRO) which is usually self-administered by the patient There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made.~The 8 scores of the 8 sections are summed and divided"|Baseline, Month 1,3,6 and 9||||score on a scale||Full Range|Mean
1271227|NCT00351273|Secondary|hsCRP|Comparison of high sensitivity C-reactive protein measurement in combination antibiotic group vs placebo group at Baseline, Month 1, 3, and 6|Baseline, Month 1, 3, and 6||||mg/litre||Full Range|Mean
1271228|NCT00351273|Secondary|Erythrocyte Sedimentation Rate (ESR)|Comparison of mean ESR rates of combination antibiotic group vs placebo group at Baseline, Month 1, 3, 6 and 9|Baseline Month 1, 3, 6 and 9||||millimeters/hour||Full Range|Mean
1271229|NCT00351273|Secondary|Number of Patients With a Complete Response (Resolution of All Symptoms)|Patients who completed full 6 months of treatment that reported feeling complete resolution of symptoms at month 6 visit and had no worsening of condition at the month 9 follow up visit.|Months 6 and 9|Patients randomized to combination antibiotics who believed that their disease went into complete remission during the trial|||Participants|||Count of Participants
1271230|NCT00351273|Primary|Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment.|The outcome measure was a composite endpoint. Participants had to meet 4/6 clinical criteria. 17/24 subjects randomized to combination antibiotics did respond to treatment when compared to 3/10 randomized to placebo.|Month 6|Efficacy and safety analyses were performed on an intent to treat(ITT) basis. Subjects who prematurely withdrew or who were lose to follow up for any reason were included in the ITT population and were considered nonresponders.|||participants|||Number
1271231|NCT00351039|Secondary|Overall Survival (Median Survival [MS])|Secondary Objective: Determine the Overall Survival (median survival[MS]) in patients with advanced NSCLC treated with this regimen. Patients were to be followed until death and survival curves were to be generated.|26 Months|Had the study been completed as planned we would have measured Overall Survival described as Median Survival. This study was closed early due to poor accrual.||||||
1271232|NCT00351039|Primary|Progression Free Survival (PFS)|The primary objective was to determine the progression free survival (PFS), in newly diagnosed patients with advanced Non Small Cell Lung Cancer (NSCLC) who are treated with a regimen consisting of Bevacizumab(B), pemetrexed(A), and erlotnib(T). This was a Phase I/II study. This trial was halted after the Phase I component was completed. The Phase II component was never initiated.|26 months|No patients proceeded to Phase II for evaluation.||||||
1271233|NCT00351039|Secondary|Number of Participants With Grade 3 and Grade 4 Adverse Events|By Safety, the intent was to capture, tabulate, list all of the grade 3 and 4 adverse effects seen by this protocol. For each toxicity, we followed the Common Toxicity Criteria(NCI CTC)Version 2.0 Toxicity scale guidelines.|26 Months|This study was initially intended to be a Phase I/II study with a brief Phase I Run-in. After the brief Phase I Run-in the study was closed without initiating the Phase II component.|||Participants|||Number
1271234|NCT00351039|Secondary|Quality of Life (QOL)|"The Scales we were intending to use were:~Instrumental Activities of Daily Living (IADL): Range of Scale 0 (Best) to 8 (Worst).~Cumulative Illness Rating Scale-Geriatric (CIRS-G): Range of Scores 1(Best) to 18 (Worst).~Functional Assessment of Cancer Therapy-Lung (FACT-L): Range of Scores 0 (Best) to 48 (Worst).~Fatigue Symptom Inventory (FSI): Range of Scores 0(Best) to 121 (Worst).~Each scale would have been evaluated independently. Since the study was not completed and closed early due to poor accrual, none of the QOL parameters were analyzed."|26 Months|Since no patients were accrued to the Phase II component of the trial, 0 patients were analyzed for these scales.||||||
1271235|NCT00351039|Secondary|Number of Patients Who Responded to Treatment|"Phase I:~Response Evaluation Criteria In Solid Tumors (RECIST)Criteria was used for Response. Partial Response (PR) is defined as at least a 30% decrease in the sum of Longest Dimention (LD) of target lesions taking as reference the baseline sum LD."|26 Months|8 patients were accrued to the Phase I component of the trial. No patients were accrued to the Phase II component of the trial.||||||
1271236|NCT00351039|Secondary|One-year Survival(1-year S)|Secondary Objective: One-year survival(1-year S) in patients with advanced NSCLC treated with this regimen.|26 Months|Had the study been completed as planned we would have measured the One-year Survival. This study was closed early due to poor accrual.||||||
1271237|NCT00351000|Primary|Change From Baseline on Fasting Insulin|Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline)|baseline, week 6||||microIU/L||Standard Deviation|Mean
1271238|NCT00351000|Primary|Change From Baseline in Fasting Glucose|Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)|baseline, week 6||||mg/dL||Standard Deviation|Mean
1271239|NCT00350870|Primary|Change in Cocaine Use by Urine Toxicology Results|We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.|12 weeks||||percentage of negative urines||Standard Deviation|Mean
1271240|NCT00350870|Primary|Change in Cocaine Use by Self Report|Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis.|12 weeks||||percentage of days abstinent||Standard Deviation|Mean
1271241|NCT00350844|Secondary|Compliance|Secondary outcome measures included compliance; laboratory measures of therapy-related toxicity; laboratory biomarkers for hemolysis, oxidative stress and endothelial injury; and quality of life measures by Child Health Questionnaire (CHQ).|Throughout study|||||||
1271242|NCT00350844|Primary|Tricuspid Regurgitant Jet Velocity|Primary outcome measure was tricuspid regurgitant jet velocity (TRJV) by echocardiogram after 6 and 12 months of hydroxyurea therapy.|6 and 12 months after HU therapy begins|Study was terminated and 0 participants were analyzed.||||||
1271243|NCT00350792|Secondary|Estimated Probability of One Year Progression-free Survival|Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.|baseline to measured progressive disease or death, 1 year|Six patients were censored as they had not experienced a qualifying event (death or first disease progression) at the time of data cut-off.|||percentage of patients||95% Confidence Interval|Median
1271244|NCT00350792|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 14.5 months)|Twenty patients were censored as they were still alive at the time of the data cut-off.|||months||95% Confidence Interval|Median
1271245|NCT00350792|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to six 21-day cycles)|All treated patients. 29 patients were censored.|||weeks||95% Confidence Interval|Median
1271246|NCT00350792|Other Pre-specified|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to six 21-day cycles)|All treated patients. 29 patients were censored.|||weeks||Standard Error|Mean
1271247|NCT00350792|Primary|Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)|Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured objective tumor response (up to six 21-day cycles)|Patients qualified for tumor response analysis: treated patients, with measurable advanced non-small cell lung cancer (NSCLC) disease and at least one tumor assessment after the patient received at least a first cycle of chemotherapy (unless early progression occurs, including early clinical progressions confirmed by the assessment committee).|||percentage of participants|||Number
1271248|NCT00350779|Secondary|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
1271249|NCT00350779|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
1271250|NCT00350779|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.|||Percent||95% Confidence Interval|Least Squares Mean
1271251|NCT00350779|Secondary|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0|Baseline and Week 18|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.|||mg/dL||95% Confidence Interval|Least Squares Mean
1271494|NCT00348790|Secondary|Overall Survival (OS)|Overall Survival will be measured from the first treatment on study until death of any cause.|Every 2 months for up to 1 year after study treatment.|Number of patients with WHO grade II or WHO grade III meningioma.|||Months||Full Range|Median
1271252|NCT00350779|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0|Baseline and 18 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.|||mg/dL||95% Confidence Interval|Least Squares Mean
1271253|NCT00350779|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 18 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.|||Percent||95% Confidence Interval|Least Squares Mean
1271254|NCT00350727|Primary|Progression-free Survival at 6 Months|Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used. The participants who are still alive and whose follow-up extends to at least 6 months are considered At Risk.|Date of the first dose of study drug to 6 months|All-treated Population for Phase II|||participants|||Number
1271255|NCT00350727|Primary|Overall Response (OR) in Phase II Based on an Independent Radiologist's Review|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population for Phase II who also had a response assessment|||participants|||Number
1271256|NCT00350727|Secondary|Time to Disease Progression or Death Due to Any Cause||Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878)|All-treated Population for Phase II|||days||95% Confidence Interval|Median
1271257|NCT00350727|Secondary|Progression-free Survival|Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used.|Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878)|All-treated Population for Phase II|||participants|||Number
1271258|NCT00350727|Primary|Overall Response (OR) in Phase II Based on the Investigator-assigned Response|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population for Phase II who also had a response assessment.|||participants|||Number
1271259|NCT00350727|Primary|Overall Response (OR) in Phase II Based GlaxoSmithKline's Evaluation|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population in Phase II who also had a response assessment|||participants|||Number
1271260|NCT00350727|Primary|Number of Participants Experiencing a Dose-limiting Toxicity at the Indicated Dose|A dose-limiting toxicity (DLT) is defined as predefined adverse events or events that prevented participants from receiving 75% of their scheduled doses or from starting their next treatment period. The dose at which no more than 1 out of 6 participants experiences a DLT is defined as the optimally tolerated regimen. The OTR is important because it determines the highest dose combination that can be given without significant toxicity.|Cycle 1 in Phase I (up to Day 28)|All-treated Population for Phase I|||participants|||Number
1271261|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Partial Thromboplastin Time and Prothrombin Time|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||seconds (sec)||Standard Deviation|Mean
1271275|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Partial Thromboplastin Time and Prothrombin Time|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||seconds (sec)||Standard Deviation|Mean
1271262|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for International Normalized Ratio (Prothrombin Time)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phases I and II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||ratio||Standard Deviation|Mean
1271263|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
1271264|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Hematocrit|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||percent||Standard Deviation|Mean
1271265|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Hemoglobin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||grams per Liter (g/L)||Standard Deviation|Mean
1271266|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Total T3|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments.|||nanomoles per liter (nmol/l)||Standard Deviation|Mean
1271267|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroid Stimulating Hormone|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||milliunits per liter (mU/L)||Standard Deviation|Mean
1271268|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Free T3 (Triiodothyronine)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments.|||picomoles per liter (pmol/l)||Standard Deviation|Mean
1271269|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroxine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||picomoles per liter (pmol/l)||Standard Deviation|Mean
1271270|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||millimoles per liter (mmol/l)||Standard Deviation|Mean
1271271|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Total Bilirubin and Creatinine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||micromoles per liter (µmol/l)||Standard Deviation|Mean
1271272|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Amylase and Lipase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||Units per liter (U/L)||Standard Deviation|Mean
1271273|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||International Units per Liter (IU/L)||Standard Deviation|Mean
1271274|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Albumin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||grams per liter (g/L)||Standard Deviation|Mean
1271326|NCT00350337|Primary|N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4|GMTs for DEN neut. antibodies –unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1|Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3|Number of subjects with titer within specified range|||GMT value||95% Confidence Interval|Mean
1271276|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for International Normalized Ratio (Prothrombin Time)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||ratio||Standard Deviation|Mean
1271277|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
1271278|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Hematocrit|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||percent||Standard Deviation|Mean
1271279|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Hemoglobin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||grams per liter (g/L)||Standard Deviation|Mean
1271280|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Total T3|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||nanomoles per liter (nmol/l)||Standard Deviation|Mean
1271281|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroid Stimulating Hormone|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||milliunits per liter (mU/L)||Standard Deviation|Mean
1271282|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroxine and Free T3 (Triiodothyronine)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||picomoles per liter (pmol/l)||Standard Deviation|Mean
1271283|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||millimoles per liter (mmol/l)||Standard Deviation|Mean
1271284|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Total Bilirubin and Creatinine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||micromoles per liter (µmol/l)||Standard Deviation|Mean
1271285|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Amylase and Lipase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||Units per liter (U/L)||Standard Deviation|Mean
1271286|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||International Units per Liter (IU/L)||Standard Deviation|Mean
1271287|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Albumin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||grams per liter (g/L)||Standard Deviation|Mean
1271288|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Heart Rate|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. bpm, beats per minute.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.|||participants|||Number
1271327|NCT00350272|Primary|The Safety Profile of Elvucitabine.|Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events and the frequency of Grade 3 and Grade 4 laboratory abnormalities.|12 Weeks|The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug.|||participants|||Number
1271289|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Diastolic Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.|||participants|||Number
1271290|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Systolic Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population (all participants who were given any dose of study medication) for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.|||participants|||Number
1271291|NCT00350727|Secondary|Phase II: Plasma Concentrations of the Circulating Biomarkers VEGF, sVEGFR-1, and sVEGFR-2.||Completed during first cycle of treatment.|||||||
1271292|NCT00350727|Secondary|Phase II: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, Tmax, and C24 of Pazopanib and Lapatinib, as Appropriate, When Administered Together in Combination With Non-EIAC.||Completed during first cycle of treatment.|||||||
1271293|NCT00350727|Secondary|Phase I: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, the Time to Maximum Observed Concentration (Tmax) and C24 of Pazopanib and Lapatinib When Administered in Combination With EIAC.||Completed during first cycle of treatment.|||||||
1271294|NCT00350636|Secondary|Change From Baseline in Average Urine Void Volume|Change from baseline to Week 12 in average urine void volume|Change from Baseline to Week 12||||mL||Standard Deviation|Mean
1271295|NCT00350636|Secondary|Baseline Average Urine Void Volume|Baseline average urine void volume|Baseline||||mL||Standard Deviation|Mean
1271296|NCT00350636|Primary|Change From Baseline in Average Daily Number of Incontinence Episodes|Change from Baseline to Week 12 in average daily number of incontinence episodes|Baseline to Week 12||||Number of episodes||Standard Deviation|Mean
1271297|NCT00350636|Secondary|Change From Baseline in Average Daily Urinary Frequency|Change from baseline in average daily urinary frequency|Baseline to 12 weeks||||Number of urinary episodes||Standard Deviation|Mean
1271298|NCT00350636|Secondary|Baseline Average Daily Urinary Frequency|Number of daily urinary voids|Baseline||||Number of urinary episodes||Standard Deviation|Mean
1271299|NCT00350636|Primary|Baseline Average Number of Daily Incontinence Episodes|Average number of daily incontinence episodes at baseline|Baseline||||Number of episodes||Standard Deviation|Mean
1271300|NCT00350623|Primary|Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks||30 weeks|No data analysis was performed.||||||
1271301|NCT00350545|Secondary|Overall Survival|Overall survival at 6 and 12 months|6 and 12 months||||Participants|||Count of Participants
1271302|NCT00350545|Secondary|Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation|Failure-free survival (FFS) was defined as participants who are surviving with no relapse and second line of cGVHD treatment.|6 and 12 Months|At initiation of therapy, all patients were on high dose of steroids (1mg/kg/day). Failure-free survival (FFS) rate for the 31 patients at 6 and 12 months post-rituximab initiation.|||Participants|||Count of Participants
1271303|NCT00350545|Secondary|Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial|Participants that decreased total daily corticosteroids ≤ 0.25mg/kg one year after rituximab infusion began|1 year||||Participants|||Count of Participants
1271304|NCT00350545|Secondary|Number of Participants With Complete and/or Partial GVHD Response|To have physician documentation of clinical GVHD response using organ staging and scoring scale- NIH clinical GVHD consensus response criteria applied 6 months after rituximab infusion began|6 months||||Participants|||Count of Participants
1271305|NCT00350545|Primary|Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.|Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse.|6 months|Participants who have complete or partial clinical response to therapy as well as a steroid dose, tapered to <0.25 mg/kg/day within 6 months after initiation of rituximab|||Participants|||Count of Participants
1271306|NCT00350532|Primary|Acetylcholine Concentration in Cerebrospinal Fluid|Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).|60 minutes|There was no difference noted in acetylcholine levels in healthy subjects compared to subjects with chronic pain|||picograms per milliliter (pg/ml)||Full Range|Mean
1271307|NCT00350519|Secondary|Hospital Length of Stay||Surgery to hospital discharge|ITT, No formal analysis was conducted due to early termination and small sample size|||days||Standard Deviation|Mean
1271308|NCT00350519|Secondary|Number of pRBC Units Transfused During Study||Baseline (Day -10) to end of study (Day 32)|ITT, No formal analysis was conducted due to early termination and small sample size|||units||Standard Deviation|Mean
1271309|NCT00350519|Secondary|Hemoglobin Change From Baseline to End of Study|End of Study Hemoglobin minus baseline Hemoglobin|Baseline (Day-10) to end of study (Day 32)|All Subjects, No formal analysis was conducted due to early termination and small sample size|||g/dL||Standard Deviation|Mean
1271310|NCT00350519|Primary|Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions||Day of surgery until hospital discharge|ITT(intention to treat), No formal analysis was conducted due to early termination and small sample size|||participants|||Number
1271311|NCT00350402|Primary|Change in Facial Entropy Score From Baseline [On Dopamine Medication]|Outcome is entropy change from baseline to immediate completion of 4 week intervention when participants remained on their normal dosage of dopamine medication. Entropy is quantitative index of facial movement that is computed from changes in pixel intensity as the face moves. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity. Greater expressivity is desired outcome.|Baseline and 4 weeks (i.e., immediate after 4-week intervention)|Based on individuals who completed baseline and post-treatment assessment following 4 weeks of intervention. One individual from each treatment group dropped out during the first week of intervention and were not included in analyses.|||Units on a scale||Standard Deviation|Mean
1271312|NCT00350402|Other Pre-specified|Change From Baseline in Maximal Inspiratory Pressure (MIP)|The dependent variable is the change in maximal inspiratory pressure (MIP) from baseline to immediate completion of 4-week intervention. MIP refers to how much air pressure force an individual creates by inhaling through the mouth as hard as possible. This was measured over 5-7 trials by placement of lips around a mouthpiece attached to a calibrated fluke digital pressure gauge. From these trials, an average maximum inspiratory pressure (MIP) was computed. This was done at baseline and post-treatment. Greater MIP changes correspond to greater treatment-related effects of exercise.|Baseline and 4 weeks (i.e., immediate after 4-week intervention)|Included participants who underwent baseline, intervention, and post-treatment assessment. Two individuals dropped out during the first week of intervention, one from each intervention group. Additionally, there was faulty data, due to equipment failure for one individual in the sham group, thereby reducing N in this group to 19.|||units of pressure (cmH20)||Standard Deviation|Mean
1271313|NCT00350402|Secondary|Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)|The PDQ-39 is a widely used quality of life measure that is specific to Parkinson disease. Total raw score on the PDQ-39 ranges from 0 to 156. Higher scores reflect worse quality of life rating. Total score on PDQ-39 was used to compute pre-post treatment changes.|Baseline and 4 weeks (i.e., immediate post-intervention)|Participants who completed baseline,intervention, and post-intervention testing. Two individuals, one from each group, dropped out of the study during the first week of intervention.|||units on a scale||Standard Deviation|Mean
1271314|NCT00350402|Primary|Change in Facial Entropy Score From Baseline [Off Dopamine Medication]|"Primary outcome is change in entropy score from baseline to immediate completion of 4 week intervention. Entropy is a computer derived index of facial movement that is computed by quantifying changes in pixel intensity as the face moves over a series of video frames. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity (desired). In this condition (off dopamine), entropy scores were obtained when participants were tested off their normal dopamine medications. Off-dopamine testing occurred after a 12-hour overnight washout period."|Baseline and 4 weeks (i.e., immediate after 4-week treatment)|All participants who completed baseline, intervention, and post-testing. Two participants, one from each group, dropped out during first week of intervention.|||units on a scale||Standard Deviation|Mean
1271315|NCT00350363|Primary|Number of Participant With Positive Culture||2 weeks||||participants|||Number
1271316|NCT00350337|Secondary|Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose.|"For vireimia:~Negative = GEQ/µl result is equal to zero Undetermined = GEQ/µL result is below LOD Positive = GEQ/µL result is >= LOD"|throughout study||||participants|||Number
1271317|NCT00350337|Secondary|Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued)|"Sero-response defined as:~For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer"|throughout study||||percentage of responders||95% Confidence Interval|Number
1271318|NCT00350337|Secondary|Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose|"Sero-response defined as:~For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer"|throughout study||||percentage of responders||95% Confidence Interval|Number
1271319|NCT00350337|Secondary|Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort)|The case definition of confirmed dengue used in this protocol requires fever (equivalent to an oral temperature ≥38.0ºC/≥ 100.4ºF) for three or more successive days, at least two of the signs or symptoms consistent with “suspected dengue” occurring during the period of fever, at least one clinical laboratory abnormality, and DEN viremia detected by RTqPCR. Cases not meeting all criteria were not considered “confirmed dengue.” The percentage of subjects with suspected or confirmed dengue were tabulated by group after each vaccination.|Days 0-30 post vaccination periods (total vaccinated cohort)||||% of participants||95% Confidence Interval|Number
1271320|NCT00350337|Secondary|Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose|"Abnormal findings at DEN physical examination were defined as:~rash, generalized rash, hemorrhages (skin, conjunctival or mucosal), conjunctival injection, hepatomegaly, splenomegaly or lymphadenopathy; generalized lymphadenopathy (palpable lymph nodes in 4 or more of the following locations: cervical, axillary, inguinal or other with right and left sides considered as separate locations) positive tourniquet test (WHO criterion of 20 or more petechiae per 2.5 cm square)Results were reported positive/negative using the WHO criterion."|throughout the 202 day study||||participants|||Number
1271321|NCT00350337|Secondary|Occurrence of Serious Adverse Events (SAEs) Throughout the Entire Study Period;|MA type = H0|up to 202 days||||participants|||Number
1271322|NCT00350337|Secondary|Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose|Summary of Unsolicited Adverse Events within 31 days after each dose of study vaccine dose (Primary total vaccinated cohort)|within 31 days of study vaccine||||Number of AEs|||Number
1271323|NCT00350337|Secondary|Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine;||within 21 days after vaccination||||participants|||Number
1271324|NCT00350337|Primary|Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine|Diary cards, digital thermometers, and small rulers were provided to subjects to record local and general solicited symptoms(pain, redness and swelling at the injection site, fatigue, headache, pain behind the eyes, abdominal pain, nausea, vomiting, muscle aches, joint aches, rash, photophobia and pruritis) and oral temperature taken daily for 21 days (days 0 through 20). The observations were to be recorded each evening and account for the previous 24 hours. If multiple temperature measurements were taken throughout the day, the maximum temperature was to be recorded.|21 days following 1st vaccination dose||||participants|||Number
1271325|NCT00350337|Primary|Percentage of Subjects With Seropositivity Rates for Dengue Serotypes 1, 2, 3 and 4|Serpositivity rates for DEN neut. antibodies –unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1|Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3||||% participants with seropositivity rates||95% Confidence Interval|Number
1271328|NCT00350272|Primary|The Proportion of Subjects With Virologic Response for 10 mg/Day Elvucitabine in HIV-1-infected Subjects by 12 Weeks Compared With the Proportion of Subjects With Lamivudine 300 mg/Day.|Proportion of subjects having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected subjects over 12 weeks compared with the proportion of subjects having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment.|12 Weeks|This primary outcome measure used the intent-to-treat population, defined as all randomized subjects who took at least 1 dose of study drug and had both a baseline HIV-1 RNA result and at least 1 HIV-1 RNA result after baseline assessment. For this analysis, all subjects who discontinued from the study before Week 12 were considered as NC=F.|||percentage of participants|||Number
1271329|NCT00350220|Primary|Peak Arterial Lactate Level|Peak arterial lactate level for the 48 hour post-op study period.|48 hours||||mmol/l||Standard Deviation|Mean
1271330|NCT00350220|Secondary|Mortality Before Hospital Discharge||30 days|||||||
1271331|NCT00350220|Secondary|Volume of Blood Transfused||3 days|||||||
1271332|NCT00350220|Secondary|Length of Vasoactive Agent Administration||3 days|||||||
1271333|NCT00350220|Secondary|Length of Oxygen Use||3 days|||||||
1271334|NCT00350220|Secondary|Length of Mechanical Ventilation||3 days|||||||
1271335|NCT00350220|Secondary|Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.||3 days|||||||
1271336|NCT00350220|Primary|Mean Arterial Lactate Level|Mean arterial lactate for the first 48 hours post-op.|48 hours||||mmol/L||Standard Deviation|Mean
1271337|NCT00350207|Secondary|Mean PEF Variability at Week 16|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 16 weeks of treatment|FAS|||ratio expressed in percent||Standard Error|Least Squares Mean
1271338|NCT00350207|Secondary|Mean PEF Variability at Week 12|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 12 weeks of treatment|FAS|||ratio expressed in percent||Standard Error|Least Squares Mean
1271339|NCT00350207|Secondary|Mean PEF Variability at Week 8|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 8 weeks of treatment|FAS|||ratio expressed in percent||Standard Error|Least Squares Mean
1271340|NCT00350207|Secondary|Mean PEF Variability at Week 4|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 4 weeks of treatment|FAS|||ratio expressed in percent||Standard Error|Least Squares Mean
1271341|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 5|Pulse rate collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||bpm||Standard Deviation|Mean
1271342|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 4|Pulse rate collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||bpm||Standard Deviation|Mean
1271343|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 3|Pulse rate collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||bpm||Standard Deviation|Mean
1271344|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5|Diastolic blood pressure collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
1271345|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4|Diastolic blood pressure collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
1271346|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3|Diastolic blood pressure collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
1271347|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 5|Systolic blood pressure collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
1271384|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12|Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose|After 12 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271348|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 4|Systolic blood pressure collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
1271349|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 3|Systolic blood pressure collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
1271350|NCT00350207|Secondary|Mini-AQLQ Overall Score at Visit 5|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271351|NCT00350207|Secondary|Mini-AQLQ Overall Score at Visit 4|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271352|NCT00350207|Secondary|Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 6 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271353|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5|Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment|After 16 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271354|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4|Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment|After 12 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271355|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3|Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment|After 6 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271356|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment|After 16 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271357|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment|After 12 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271358|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment|After 6 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271359|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271360|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271361|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271362|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271363|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271364|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271385|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8|Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose|After 8 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271365|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271366|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271367|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271368|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271369|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271370|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271371|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271372|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271373|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271374|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271375|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271376|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271377|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271378|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271379|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271380|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271381|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271382|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
1271383|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16|Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose|After 16 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
1271399|NCT00350207|Primary|Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial|Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit|baseline and after 16 weeks of treatment|The Full analysis set (FAS) included patients who received at least one dose of randomised study medication and who had at least four patient diary records for at least one efficacy endpoint in any week after the first administration of the randomised treatment and baseline data for the corresponding efficacy endpoint.|||L/min||Standard Error|Least Squares Mean
1271400|NCT00350142|Secondary|Median Overall Survival Time|The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.|up to 3 years||||months||Full Range|Median
1271401|NCT00350142|Primary|Rate of Local Control|"The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.~Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression."|up to 3 years||||participants|||Number
1271402|NCT00350025|Secondary|Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging||Measured by CT scans after every 2 cycles of treatment (about every 8 weeks)|Overall Survival|||weeks||95% Confidence Interval|Median
1271403|NCT00350025|Primary|Progression Free Survival||Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.||||weeks||95% Confidence Interval|Median
1271404|NCT00349973|Primary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.|Baseline and Follow-Up|Participants completing cognitive testing.|||units on a scale||Standard Deviation|Mean
1271405|NCT00349973|Primary|Change in Negative Symptoms by Treatment Assignment|The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Mean SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Baseline and Follow-Up|Participants completing SANS assessment.|||units on a scale||Standard Deviation|Mean
1271406|NCT00349973|Primary|Change in Positive Symptoms by Treatment Assignment|"The Brief Psychiatric Rating Scale (BPRS) consists of 20 items, with 6 of these items used to assess positive symptom change. The BPRS positive symptom items are: somatic concern, conceptual disorganization, hostility, suspiciousness, hallucinatory behavior, and unusual thought content. Each scale ranges from 1=Not Present to 7=Very Severe. A higher score indicates a more severe positive symptom rating."|Baseline and follow-up|Participants completing the BPRS assessment.|||units on a scale||Standard Deviation|Mean
1271407|NCT00349921|Primary|Number Meeting Success Criterion|Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection|baseline and 2 hours|The primary outcome measure will be % change in pain report 2 hr following injection, using a response criterion of 30% reduction in ongoing pain.|||participants meeting success criterion|||Number
1271408|NCT00349908|Primary|Technical Feasibility- Percent Stenosis (Post Procedure)|Percent Stenosis assessed immediately post procedure from pre procedure|Post Procedure|Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.|||Percentage Change from PreProcedure||Standard Deviation|Mean
1271409|NCT00349908|Primary|Technical Feasibility- Percent Stenosis (6 mo Post Procedure)|Percent Stenosis assessed 6 mo Post Procedure from pre-procedure|6 mo|Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.|||Percentage change from PreProcedure||Standard Deviation|Mean
1271410|NCT00349908|Primary|Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)|Successful stent/coil placement assessed at 6 mo post|6 mo||||Percentage of stable stent/coil placemen|||Number
1271411|NCT00349908|Primary|Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)|6 Months post|6 mo|Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.|||percent occlusion||Full Range|Mean
1271412|NCT00349908|Primary|Technical Feasibility- Percent Occlusion (Post Procedure)|Occlusion evaluated immediately post procedure|post procedure|Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.|||percent occlusion||Full Range|Mean
1271413|NCT00349908|Secondary|The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.|An adverse event was defined as any untoward medical occurrence in a subject.|6 months|Group 1 and Group 2 were analyzed separately. In group 1 Atherosclerosis, 25 unique adverse events were reported in 8 of the 10 eligible subjects. In group 2 aneurysm, 28 unique adverse events were reported in 9 of the 10 eligible subjects.|||Number of adverse events|||Number
1271414|NCT00349908|Primary|Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)|Successful placement of the product assessed immediately post procedure|post procedure||||percentage of stable placement|||Number
1271415|NCT00349778|Secondary|Number of Participants That Relapse After Autologous Transplantation|Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation|5 years||||Participants|||Count of Participants
1271416|NCT00349778|Secondary|Overall Participant Survival (OS)|Survival status was assessed 5 years after transplant.|5 years||||Participants|||Count of Participants
1271417|NCT00349778|Primary|Number of Participants With Pulmonary Toxicity|Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.|2 years||||Participants|||Count of Participants
1271418|NCT00349752|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38|The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points.|Week 0, Week 38|Of the 87 (Placebo) and 87 (Certolizumab Pegol 400 mg) subjects randomized, 23 and 26 subjects respectively had available values at Baseline and Week 38 and are included in the summary based on the intention-to-treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1271419|NCT00349752|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38|The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points.|Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 23 and 27 subjects respectively had available values at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1271420|NCT00349752|Secondary|Change From Baseline in CDAI Score at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0, Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively had available values at Baseline and at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1271421|NCT00349752|Secondary|Crohn's Disease Activity Index (CDAI) Score at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively are included in the summary of the Week 38, based on the intention-to-treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1271422|NCT00349752|Secondary|Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period|The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study.|6-week run-in period, 38-week double-blind treatment period|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 86 in each group had available values at the 6-week run-in period and over the 38-week double-blind treatment period.|||mg per week||Standard Deviation|Mean
1271423|NCT00349752|Secondary|Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period|The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here.|Over the 48-week study period|87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.|||mg||Standard Deviation|Mean
1271424|NCT00349752|Secondary|Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period|The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here.|Over the 38-week double-blind treatment period|87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.|||mg per week||Standard Deviation|Mean
1271425|NCT00349752|Secondary|Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period|A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]|During the 38-week double-blind treatment period|Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0|||days||Standard Deviation|Mean
1271426|NCT00349752|Secondary|Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38|A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]|Week 38|Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0|||percentage of subjects|||Number
1271427|NCT00349752|Secondary|Percentage of Subjects With Continuous Remission Off Steroids at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.|Week 38|Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.|||percentage of subjects|||Number
1271428|NCT00349752|Primary|Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.|Week 38|Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.|||percentage of subjects|||Number
1271429|NCT00349713|Secondary|Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time|Proportion of Subjects with 2- and 4-fold increases in Anti-FMP2.1 Antibody levels on days 14, 30, 44, 60, 74 and 90|90 Days||||number of participants with increase|||Number
1271430|NCT00349713|Secondary|Geometric Mean Antibody Titers Over Time|Measurement of geometric mean antibody titers on days 0, 14, 30, 44, 60, 74 and 90|90 Days||||Geometric Mean of Antibody Titers||95% Confidence Interval|Geometric Mean
1271431|NCT00349713|Secondary|Anti-AMA1 Log Antibody Titers Over Time|Summary of Anti-AMA1 Log Antibody titers on days 0, 14, 30, 44, 60, 74 and 90|90 Days||||log antibody titers||Standard Deviation|Mean
1271432|NCT00349713|Secondary|Antibody Response to FMP2.1 Over Time|Measurement of anti-AMA1 antibody titers over time|90 Days|Anti-AMA1 Antibody titers on days, 0, 14, 30, 44, 60, 74, and 90|||Antibody Titers||Standard Deviation|Mean
1271433|NCT00349713|Primary|Safety and Reactogenicity (SAEs and AEs)|The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination.|12 months|Summary of Adverse Events by Group and Immunization Group|||Number of events|||Number
1271434|NCT00349622|Secondary|Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year|"Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally.~HHD analysis was performed using Percent Change from Baseline. Each subject’s baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year||||Percent change per 12 weeks||Standard Error|Mean
1271435|NCT00349622|Secondary|Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year|"The ALS-Specific Quality of Life Scale (ALSQOL). was developed, tested, and validated in subjects with ALS, and is not a health-related quality of life scale. The scale consists of 59 questions that ask about severity of the symptoms of ALS, mood and affect, intimacy, and social issues. Each question for the ALSQOL is scored from 0-10. With 59 questions, total score ranges from 0-590 with scores simply added, with 590 representing highest quality of life. However since 10 is maximally weighted towards negative values on some questions and positive values on others, the following questions must have results transposed (Simply reverse the scale, for instance 10=0 and 0=10) prior to analysis: 1-10, 11, 16, 19, 24, 26, 28, 32, 35, 36, 38, and 41. Optional items are 50, 53, 56, and 59. These questions are not included on any scale or in any quantitative analyses.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year||||units on a scale per 12 weeks||Standard Error|Mean
1271436|NCT00349622|Secondary|Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year|"Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally.~HHD analysis was performed using Percent Change from Baseline. Each subject’s baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year||||Percent change per 12 weeks||Standard Error|Mean
1271437|NCT00349622|Secondary|Change in % Vital Capacity From Screening to One Year|"Vital Capacity is measured as the percent predicted per subject based on age, gender, and height, and is performed as a Slow Vital Capacity.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year||||percent change in VC per 12 weeks||Standard Error|Mean
1271438|NCT00349622|Primary|Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year|"Amyotrophic Lateral Sclerosis Functional Rating Scale, Revised (ALSFRS-R) is a quickly administered (five minute) ordinal rating scale used to determine patients' assessment of their capability and independence in 12 functional activities/questions. The 12 functional activities/questions are rated on a scale of 0 to 4 for a total scoring range of 0-48, with 48 representing optimal function. All 12 activities are relevant in ALS.~This outcome measure calculation is based on measurements every 8 weeks from the Baseline Visit up until one year."|Every 8 weeks for one year||||units on a scale per 8 weeks||Standard Error|Mean
1271439|NCT00349622|Primary|Survival|Survival is presented as median day of survival for each group. Survival is defined as time to death, tracheostomy or the initiation of permanent assisted ventilation (PAV).|From date of randomization until date of death, tracheostomy, or the initiation of permanent assisted ventilation (PAV). This was assessed at time of each participant's drug discontinuation and every 2 months thereafter for the life of the study (6 yrs)||||days||95% Confidence Interval|Median
1271444|NCT00349466|Primary|Fluorescein Staining of the Cornea|Severity of corneal epithelial loss as graded by Fluorescein Staining of the cornea, assessed on a 0-4+ scale with 0 = none and 4+ = severe de-epithelialization, expressed as number of participants with >25% improvement at Week 12 relative to baseline|Baseline and 12 weeks|Per protocol, observed values|||Participants|||Number
1271445|NCT00349466|Primary|Tear Break-Up Time|time elapsed between a complete blink and the development of the first random dry spot on the tear film|12 weeks|||||||
1271446|NCT00349466|Primary|Schirmer Test (ST)|involved placing a standardized paper tear strip inside the lower eyelid for 5 minutes. The tear strip was then removed and the length of the strip that was wet from tears was measured in millimeters|12 weeks|||||||
1271447|NCT00349388|Secondary|Improved Medication Compliance.|unable to measure since no one enrolled in second arm. Therefore, no comparisons can be made.|overall study|||||||
1271448|NCT00349388|Primary|Once Daily Dosing Works as Well a Multiple Dosing a Day.|subject tolerated once a day dose Only 1 subject enrolled which was the control arm standard dose twice a day. No subjects enrolled to take dose once a day Therefore, primary outcome cannot be reported|overall study|cannot analysze primary outcome because no subjects were enrolled in the once a day dose arm. Study was terminated due to lack of enrollment||||||
1271449|NCT00349349|Secondary|Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
1271450|NCT00349349|Secondary|Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)|CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1271451|NCT00349349|Secondary|Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)|Half-life ( t1/2) is defined as the terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 9 (Week 7) and Visit14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
1271452|NCT00349349|Secondary|AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. AUC(0-tau) is AUC from the start of infusion over the dosing interval.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milligrams x hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
1271453|NCT00349349|Secondary|Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)|Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the trough serum concentration (measured concentration at the end of a dosing interval [taken directly before the next administration]). No drug was present before the first infusion; therefore, there are no Ctrough results for Dose 1|Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
1271454|NCT00349349|Secondary|Number of Participants Who Experienced Any Adverse Event|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.|From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up)|FAS|||participants|||Number
1271455|NCT00349349|Secondary|Number of Participants With Complete Resolution of Splenomegaly|Participants with complete resolution of enlarged spleen (splenomegaly) were defined as those with an enlarged palpable spleen at baseline followed by the absence of splenomegaly post-baseline (i.e., the spleen was of normal size). Spleen size was assessed by physical examination and documented as “centimeters” under the costal margin with relative changes in spleen size in 1 dimension calculated based on palpated numeric measurements (as per the 1996 NCIWG guidelines).|Baseline (Visit 2) until Week 24|FAS. Data were provided for the number of participants with splenomegaly at baseline attending each visit. Participants withdrawn during the study were not analyzed. Only participants with baseline splenomegaly and a post-baseline assessment are included.|||participants|||Number
1271456|NCT00349349|Secondary|Number of Participants With Improvement in Neutropenia|Low levels of neutrophils (neutropenia) may increase the risk of developing serious infections and may be considered an adverse condition and evaluated on the NCI CTC with a grade. Improvement in neutropenia is defined as a decrease from Visit 2 (baseline) by at least one NCI CTC grade. Improvement is defined as a decrease from Visit 2 by at least one NCI CTC grade.|Baseline (Visit 2) to Week 28|FAS. Only those par. remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.|||participants|||Number
1271457|NCT00349349|Secondary|Number of Participants With Complete Resolution of Hepatomegaly|Participants with complete resolution of enlarged liver (hepatomegaly) were defined as those with an enlarged palpable liver at baseline followed by the absence of hepatomegaly post- baseline (i.e., the liver was of normal size). Liver size was assessed by physical examination and documented as “centimeters” under the costal margin with relative changes in spleen size in 1 dimension calculated based on palpated numeric measurements (as per the 1996 NCIWG guidelines).|Baseline (Visit 2) until Week 24|FAS. Data were provided for the number of participants with hepatomegaly from baseline attending each visit. Participants withdrawn during the study were not analyzed. Only participants with baseline hepatomegaly and a post-baseline assessment are included.|||participants|||Number
1271458|NCT00349349|Secondary|Number of Participants With Improvement in Thrombocytopenia (Thromb.)|Improvement in thromb. is defined as a decrease from Visit 2 by >=1 National Cancer Institute Common Terminology Criteria (NCI CTC) grade. Thromb. is defined as low platelet counts resulting from refractory CLL, damage from prior treatment, advanced age, or reduced bone marrow function and can be considered as an adverse condition. Adverse events (AEs) such as thromb. in a cancer indication are graded on a scale determined by the NCI called the NCI CTC: lowest, grade 1; highest, grade 5 (death). Changes in this grading can assess improvements or declines in the severity of the AE.|Baseline (Visit 2) to Week 28|FAS. Only those participants remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.|||participants|||Number
1271459|NCT00349349|Secondary|Number of Participants With Improvement in Hemoglobin|The number of participants (par.) who had improvement in hemoglobin levels >=11 grams (g)/deciliter (dl) (6.8 millimoles/liter) or 50% improvement over baseline was measured.|Baseline (Visit 2) to Week 28|FAS. Par. were excluded from analysis if they received treatment of red blood cells (RBCs), received transfusions or a RBC growth factor (erythropoietin), died, withdrew from the trial, or began next CLL treatment. Only those par. remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.|||participants|||Number
1271460|NCT00349349|Secondary|Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening|The number of participants (par.) who were positive, negative, or had missing data for the following prognostic factors indicative of altered responsiveness to treatment and/or survival was measured: 17p-, 11q-, +12q, 6q-, 13q-. Par. were assessed by FISH for these chromosomal abnormalities known tobe prognostic for time to treatment and survival when detected at diagnosis. Par. were categorized by the chromosomal abnormality detected: 17 p deletion, 11q deletion (but not 17 p deletion), 12 q trisomy (but not 17 p or 111q deletion), 13q deletion only, and no chromosomal abnormalities found.|Screening (Visit 1, <=14 days prior to Visit 2)|FAS. Par. were categorized hierarchically (by severity of abnormality): par. with a 17 p deletion (D); par. with an 11q D, but not a 17 p D; par. with 12q trisomy, but not a 17p or 11q D; par. with no aberrations found; par. with a 13q D as the sole aberration; and par. with 6q D (and not any of the above categories). Some par. had missing data.|||participants|||Number
1271461|NCT00349349|Secondary|Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24|ECOG performance status is a measure of the participant’s ability to carry out activities of daily living on 6-point scale (0=fully active, 1=restricted in physically activity, ambulatory, 2=ambulatory [>50% of waking hours], 3=capable of only limited self care, 4=completely disabled, 5=Dead). Improvement in ECOG performance status is defined as a decrease from baseline by at least one score on the ECOG scale.|Baseline (Visit 2) and Week 24|FAS. Data were provided for participants (par.) with an ECOG score >0 at baseline attending each visit. Par. withdrawn from the study were not analyzed. (55 par. had an ECOG performance status of 0 at baseline and therefore did not have the opportunity to improve. No par. with an ECOG score of 0 at baseline worsened during the trial.)|||participants|||Number
1271462|NCT00349349|Secondary|Number of Participants With Complete Resolution of Lymphadenopathy|Participants with complete resolution of lymphadenopathy (disease involving the lymph nodes) were defined as those in whom all observed lymph nodes were of normal size (all nodes <1 centimeters) as determined by physical examination assessed by the investigator. All palpable lymph node sizes were recorded.|Baseline (Visit 2) to end of study (up to Week 24)|FAS. Data were provided for the number of participants with lymphadenopathy at baseline attending each visit. Participants withdrawn during the study were not analyzed. (Participants without baseline lymphadenopathy remained free of lymphadenopathy during the trial.)|||participants|||Number
1271463|NCT00349349|Secondary|Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24|Participants with complete resolution of constitutional symptoms were those in whom no constitutional symptoms, such as night sweats, weight loss, and fever or extreme fatigue, were observed.|Baseline (Visit 2) and Week 24|FAS. Data were provided for the number of participants with constitutional symptoms at baseline attending each visit. Participants withdrawn during the study were not analyzed. (Participants without baseline constitutional symptoms did not experience new constitutional symptoms during the trial period.)|||participants|||Number
1271464|NCT00349349|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14)|Tumor size and change in tumor size will be measured by the absolute value of and the percent change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24 (Visit 14). Percent change from Visit 2 (Baseline, Week 0) = (value at Week 24 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 24 (Visit 14)|FAS|||percent change in tumor size||Full Range|Median
1271465|NCT00349349|Secondary|Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts|The peripheral blood for each participant was collected and analyzed for CD5+CD20+ cell counts. CD is “cluster of differentiation,” is a cell surface marker for immunophenotyping, and, in this case, is a surrogate for B cell malignancy (indicates malignant B cells). Percent change from Visit 2 (Week 0, Baseline) = (value at Week 7 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 7 (Visit 9)|FAS|||percent change in cell counts||Full Range|Median
1271466|NCT00349349|Secondary|Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts|The peripheral blood for each participant was collected and analyzed for CD5+CD19+ cell counts. CD is “cluster of differentiation,” is a cell surface marker for immunophenotyping, and, in this case, is a surrogate for B cell malignancy (indicates malignant B cells). Percent change from Visit 2 (Week 0, Baseline) = (value at Week 7 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 7 (Visit 9)|FAS|||percent change in cell counts||Full Range|Median
1271467|NCT00349349|Secondary|Overall Survival|OS is defined as the time from allocation to death. OS will also be subgrouped for responders and non-responders.|Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks)|FAS|||months||95% Confidence Interval|Median
1271495|NCT00348790|Secondary|Number of Months Patients Survive After Being Treatment on the Study.||From the date the first patient began treatment until the date the last patient became deceased.||||months||95% Confidence Interval|Median
1271468|NCT00349349|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment|Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).|Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months])|FAS|||months||95% Confidence Interval|Median
1271469|NCT00349349|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression/death. Per the IRC, if the participant had progression between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity/other reason, new anti-cancer treatment, and death/progression after 2 or more missed visits in a row, the endpoint was censored. Clinical progression is not considered as progression endpoint.|Start of treatment (Week 0 of Visit 2) until Week 24|FAS|||months||95% Confidence Interval|Median
1271470|NCT00349349|Secondary|Duration of Response|Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.|Start of treatment (Week 0 of Visit 2) until Week 24|FAS|||months||95% Confidence Interval|Median
1271471|NCT00349349|Primary|Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines|Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) were classified as responders, while those with stable disease (SD) and progressive disease (PD) were classified as non-responders. Per the NCIWG guideline (1996): CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, bone marrow sample as normocellular for age, <30% lymphocytes (LC), no lymphoid nodule; PR: a >=50% decrease in LC/lymphadenopathy; nPR: persistent nodules in bone marrow; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.|Start of treatment (Week 0 of Visit 2) until Week 24|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Participants not evaluable (NE) were due to patient withdraw, refusal, non-trial drug related AEs, and death|||participants|||Number
1271472|NCT00349336|Secondary|Terminal Half-life of Bevacizumab|Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||hr||Standard Deviation|Mean
1271473|NCT00349336|Secondary|Volume of Distribution of Bevacizumab at Steady State|Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||L||Standard Deviation|Mean
1271474|NCT00349336|Secondary|Time of Maximum Serum Concentration of Bevacizumab|Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||hr||Standard Deviation|Mean
1271475|NCT00349336|Secondary|Serum Clearance of Bevacizumab|Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||L/day||Standard Deviation|Mean
1271476|NCT00349336|Secondary|Minimum Serum Concentration of Bevacizumab at Steady State|Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||ug/ml||Standard Deviation|Mean
1271477|NCT00349336|Secondary|Maximum Serum Concentration of Bevacizumab at Steady State|Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||ug/mL||Standard Deviation|Mean
1271478|NCT00349336|Secondary|Steady-state Exposure of Bevacizumab From Time Zero to Tau|Area under the serum concentration-time curve from time zero to tau, at steady state (AUCss 0-tau), where tau was the length of the cycle, i.e., tau = 3 weeks for XELOX+BV and tau = 2 weeks for FOLFOX-4+BEV. Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||day*ug/mL||Standard Deviation|Mean
1271479|NCT00349336|Primary|Weekly Steady-state Exposure of Bevacizumab|Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||day*ug/mL||Standard Deviation|Mean
1271533|NCT00348374|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit|Change in mean glycosylated hemoglobin A1c (HbA1c %) from Baseline to each visit through Week 24. Change = mean value at observation minus mean value at Baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; LOCF; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||percent||Standard Deviation|Mean
1271480|NCT00349336|Secondary|Time Zero to Last Measurable Plasma Concentration of Bevacizumab|Area under the serum concentration-time curve from time zero to the time of the last measurable plasma concentration (AUC 0-last). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||day*ug/mL||Standard Deviation|Mean
1271481|NCT00348933|Secondary|Change in RBC Folate||Baseline, 1 year|Analysis per protocol|||ng/mL||Standard Deviation|Mean
1271482|NCT00348933|Secondary|Change in Levels of Betaine, Creatine, Dimethylglycine, Guanidinoacetate, Homocysteine, and Methionine.||Baseline, 1 year|analysis per protocol|||mmol/L||Standard Deviation|Mean
1271483|NCT00348933|Primary|Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills|"Primary:~Bayley Scales of Infant Development measures Mental Developmental Index standard scores 0 (least skilled) - 100 (most skilled) Psychomotor Developmental Index standard scores 0 (least skilled - 10 (most skilled) Vineland Adaptive Behavior Scales (VABS), Communication standard scores 0 (least skilled) - 100 (most skilled) Daily Living Skills standard scores 0 (least skilled) - 100 (most skilled) Socialization standard scores 0 (least skilled) - 100 (most skilled) Motor Skills standard scores 0 (least skilled) - 100 (most skilled) Preschool Language Scale (PLS), Auditory Comprehension 0 (least skilled) - 100 (most skilled) Expressive Communication 0 (least skilled) - 100 (most skilled)"|Baseline, 1 year|Analysis per protocol|||units on a scale||Standard Deviation|Mean
1271484|NCT00348881|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.~Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 to Day 7 after vaccination|Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received.|||Participants|||Number
1271485|NCT00348881|Primary|Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.|Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.|Day 0 to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point.|||Participants|||Number
1271486|NCT00348881|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.|1 month post third vaccination|GMTs were assessed in a subset of the participants available for the endpoint, the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1271487|NCT00348881|Primary|Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.~Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination."|1 month post third vaccination|Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population.|||Participants|||Number
1271488|NCT00348816|Secondary|Correlation Between Velocity of Subsequent PSA Failure and Survival||5 years|N/A no study data was recorded for this outcome||||||
1271489|NCT00348816|Secondary|Overall Survival||5 years|N/A no data recorded||||||
1271490|NCT00348816|Secondary|Progression-free Survival Based on PSA Progression|Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up.|5 years|One subject was not included in analysis due to taken off study due to non-compliance|||Participants|||Count of Participants
1271491|NCT00348816|Primary|Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.|Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..|5 years|Exceptions to group description: (1) one subject non-compliant and taken off study (not included in analysis); (2) one subject did not receive docetaxel #7 during radiation due to change in performance status; (3) one subject received only 1 post radiation docetaxel; (4) two subjects did not receive post radiation docetaxel #4.|||Participants|||Count of Participants
1271492|NCT00348790|Other Pre-specified|To Use the FACT BR Questionnaire to Measure Quality of Life|FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment|At baseline and then every time an MRI is performed while on study treatment.|Data not collected or analyzed.||||||
1271493|NCT00348790|Other Pre-specified|Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels|Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment|MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment|Data not collected and analyzed.||||||
1271496|NCT00348790|Secondary|Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas|"Safety of vatalanib will be assessed using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE) 3.0 and graded using the following:~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Fatal"|Every week while on study treatment until 30 days after last treatment.|Toxicities determined to be either grade 3 or grade 4 and at least possibly related to study drug are reported here.|||participants|||Number
1271497|NCT00348790|Secondary|To Correlate the Response Rates With Expression of Certain Types of Genes|Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes|At the end of study treatment|Data not collected and analyzed.||||||
1271498|NCT00348790|Secondary|Best Overall Response Rate (ORR)|"Overall Response Rate (ORR) will be as assessed by MRI scan every 2 months while on study treatment and follow-up for up to 1 year after discontinuation of study treatment. The RR is the best response recorded from the start of the treatment until disease progression (PD) where the following definitions apply.~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.~Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable/No Response: Does not qualify for CR, PR, or PD Progressive disease (PD):25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) worsening of evaluable disease, new lesions, clinical worsening OR failure to return for evaluation due to death/deteriorating condition"|Every 2 months for up to 1 year after study treatment.|3 patients not evaluable.|||Participants|||Count of Participants
1271499|NCT00348790|Secondary|Determine Efficacy (Radiographic and Clinical Improvement)|Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment|At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment|Data not collected. Statistical design of study was based on participation of patients with WHO grade I meningioma. Most patients enrolled in the study were WHO grade II and WHO grade III.||||||
1271500|NCT00348790|Primary|Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.|Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.|From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment||||Participants|||Count of Participants
1271501|NCT00348686|Secondary|Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine|Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only 91 patients are available for analysis|||percent change||Full Range|Median
1271502|NCT00348686|Secondary|Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only|Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only 201 patients are available for analysis.|||percent change||Full Range|Median
1271503|NCT00348686|Secondary|Change of Diastolic Blood Pressure (DBP)|"Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.~Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data."|At Baseline and 24 weeks|Last Observational carried forward|||mmHg||Full Range|Median
1271504|NCT00348686|Secondary|Change of Systolic Blood Pressure (SBP)|Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only who has systolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.|||mmHg||Full Range|Median
1271505|NCT00348686|Secondary|LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index|Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area.|At Baseline and 24 weeks|Only 245 patients who have reliable Echocardiac data were analyzed.|||g/m^2||Full Range|Median
1271506|NCT00348686|Primary|Percent Change of B Type Natriuretic Peptides (BNP) Level|Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.|At Baseline and 24 weeks|Followed Intent-to-treat analysis|||Percent Change||Full Range|Median
1271507|NCT00348673|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)||0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.|||hrs||Full Range|Median
1271508|NCT00348673|Other Pre-specified|Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.|||ng/mL||Standard Deviation|Geometric Mean
1271509|NCT00348673|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss)|AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen.|0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1271510|NCT00348673|Secondary|Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load|Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported.|Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])|Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.|||participants|||Number
1271511|NCT00348673|Primary|Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8|Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.|Baseline, Day 8|Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.|||log10 copies/mL||Standard Deviation|Mean
1271512|NCT00348556|Secondary|Change in Urinary Sodium Excretion at 24 Hours|The fractional excretion of sodium (FENa) measures the percent of filtered sodium that is excreted in the urine. This calculation is widely used to help differentiate prerenal disease (decreased renal perfusion) from acute tubular necrosis (ATN) as the cause of acute kidney injury (AKI, formerly called acute renal failure).|baseline, 24 hours after start of infusion|The data from the 3 subjects were incomplete and could not be analyzed.||||||
1271513|NCT00348556|Primary|Change in Glomerular Filtration Rate (GFR) at 24 Hours|Kidney function was to be measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|baseline, 24 hours after start of infusion|The data from the 3 subjects were incomplete and could not be analyzed.||||||
1271514|NCT00348374|Secondary|Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)|Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
1271515|NCT00348374|Secondary|Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)|Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
1271516|NCT00348374|Secondary|Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24|"Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction.~Change = difference in mean Patient Satisfaction with Insulin Treatment (PSIT) score from Week 4 to Week 24."|Week 4, Week 24|Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.|||scores on scale||Standard Deviation|Mean
1271517|NCT00348374|Secondary|Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)|Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = mean Patient Satisfaction of Insulin Treatment (PSIT) score at observation minus mean score at Baseline.|Week 4, Week 24|Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.|||scores on scale||Standard Deviation|Mean
1271518|NCT00348374|Secondary|Crude Hypoglycemic Event Rate|Crude event rate = (number of events)/(subject months); severe hypoglycemic events: crude event rate = (number of events)/(100 subject months). Severe = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or unmeasured but clinical manifestestation reversed by oral carbohydrates or glucose. Non-severe events = mild-moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||events per subject months|||Number
1271519|NCT00348374|Secondary|Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment|Subject months of treatment = number of days from start of treatment to last day of active treatment + 1 day lag (total number of subjects treated * days treated), including off-drug time)/30.44. Severity: severe = subject unable to treat self, had at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams/deciliter; or not measured but clinical manifestations were reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||subject months of treatment|||Number
1271520|NCT00348374|Secondary|Number of Total Hypoglycemic Events|Total number and severity of hypoglycemic events. Severe events = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||events|||Number
1271521|NCT00348374|Secondary|Number of Subjects With Hypoglycemic Events|Severe event = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild-moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||participants|||Number
1271522|NCT00348374|Secondary|Baseline Prandial Insulin Dose (at Each Meal) at Each Visit|Dose of inhaled insulin prior to each meal at each visit.|Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||mg||Standard Deviation|Mean
1271523|NCT00348374|Secondary|Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)|Change from Baseline in insulin glargine at each visit. Change = mean at observation minus mean Baseline observation. Basal dose = injection of basal insulin (IU) (insulin glargine).|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Safety population: all subjects who received at least one dose of study medication; Lispro international units (IU) were converted to milligrams (mg) equivalent; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||IU||Standard Deviation|Mean
1271524|NCT00348374|Secondary|Change From Baseline in Fasting Plasma Lipids|Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
1271525|NCT00348374|Secondary|Change From Baseline Weight at Each Visit|Change = mean body weight at observation minus mean body weight at Baseline.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; LOCF (all visits except Baseline); N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||kilograms||Standard Deviation|Mean
1271526|NCT00348374|Secondary|Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests|Cardiovascular risk markers included serum high-sensitivity C-reactive protein (hs-CRP)[mg/L], leptin (ng/mL), adiponectin (ug/mL), and spot urine microalbumin. Change = observation of mean fasting and postprandial markers of cardiovascular risk at Week 12 and Week 24 minus mean Baseline observation.|Week 12, Week 24|Due to cancellation of the EXUBERA program, too few patients participated to explore the markers of cardiovascular (CV) risks so these markers were not summarized.|||participants|||Number
1271527|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests|Change from Baseline in fasting and postprandial lipids at Week 12 and Week 24 as determined by standard meal tolerance tests. Change = value at observation minus value at Baseline. Postprandial = 120 mins after meal.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
1271528|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24|Change from Baseline in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 24 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.|Baseline, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
1271529|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12|Change from Baseine in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 12 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.|Baseline, Week 12|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
1271530|NCT00348374|Secondary|Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles|Mean change from Baseline in fasting and 2-hour postprandial glucose at each visit in 8-point self-monitored blood glucose (SMBG) profiles: includes values prior to each meal (breakfast, lunch and dinner), 2 hours after each meal, at bedtime, and at 2:00 ante meridiem (a.m.) Change=observation value minus Baseline value.|Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
1271531|NCT00348374|Secondary|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24|Number of subjects that attained HbA1c target levels of <7%, < 6.5%,and <6.0% at Week 24 without an episode of severe hypoglycemia.|Week 24|FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||participants|||Number
1271532|NCT00348374|Secondary|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24|Number of subjects acheiving glycemic control: HbA1c target levels of <7.0%, <6.5%, and <6.0% at Week 24.|Week 24|FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||participants|||Number
1271534|NCT00348374|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment|Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.|Baseline, Week 24 (End of Treatment)|Full analysis set (FAS): subjects who received at least one dose of study medication, had a baseline glycosylated hemoglobin A1c (HbA1c%) measurement, and had a post-baseline HbA1C measurement; last (post-baseline) observation carried forward (LOCF). Number of subjects with HbA1c values at Baseline and Week 24: Exubera® n=81, Lispro n=90.|||percent||Standard Deviation|Mean
1271535|NCT00348348|Secondary|Microbial Eradication|Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated|Day 8 or Day 9|modified intent to treat (mITT), culture confirmed, as treated|||Participants|||Number
1271536|NCT00348348|Secondary|Clinical Resolution|Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated|Day 8 or Day 9|modified intent to treat (mITT), culture confirmed, as treated|||Participants|||Number
1271537|NCT00348348|Primary|Microbial Eradication|eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated|Day 5 (+/- 1 day)|modified intent to treat (mITT), culture confirmed, as treated|||Participants|||Number
1271538|NCT00348348|Primary|Clinical Resolution|Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)|Day 5(+/- 1 day)|modified intent to treat (mITT), culture confirmed, as treated|||Participants|||Number
1271539|NCT00348309|Secondary|Change From Baseline in Alzheimer’s Carer Quality of Life Instrument (ACQLI) Total Score|The ACQLI was an assessment of caregiver quality of life. This instrument consists of 30 questions exploring various aspects of carer’s quality of life. Each of the questions had a two point response and the 30 questions were summed to provide a total score. Items are assumed to be unidimensional (i.e., represent a single variable) and are scored 0/1 (false/true) before summation into a total score with a 0–30 range. The total score ranged from 0 to 30, where 0 indicated absence of symptoms and higher score indicated worse outcomes; a negative change from baseline indicated improvement. Change from baseline was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 12, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1271540|NCT00348309|Secondary|Number of Participants With Laboratory Potential Clinical Concern (PCC) Values|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Hematocrit 0.8, 1.2; hemoglobin 10-11, 16.5-18; Red blood corpuscles(RBC) 0.8, 1.2; mean corpuscular volume (MCV) 0.8, 1.2; mean corpuscular hemoglobin (MCH) 0.8, 1.2; White blood corpuscles (WBC) 3- absolute value, 15-absolute value, Red Cell Distribution Width (RDW) 0.8, 1.2; Lymphocytes 0.75, 1.5; Monocytes NA, 2; Eosinophil NA, 2; platelet count 100-absolute, 500-absoulte; segmented neutrophil (SN) 0.75, 1.5 and Total Neutrophil (TN) 0.75, 1.5.|Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56|Safety population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1271541|NCT00348309|Secondary|Change From Baseline in HbA1c at Week 12, Week 24 and Week 36|Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Change from Baseline in HbA1c was calculated as the value at time point minus the value at Baseline.|Baseline (Week 0) and Week 12, 24 and 36|Safety population. Week 12, Week 24 and Week 36 assessments of HbA1c were only needed in participants whose HbA1c was >= 6.5% at screening or who had known Type 2 diabetes. Only those participants available at the specified time points were analyzed.|||Percent of total hemoglobin||Standard Deviation|Mean
1271542|NCT00348309|Secondary|Mean Change From Baseline in Short Term Memory Assessment Score|Short term memory assessment score was based on ADAS-Cog questionnaire (Question 1 and 7). ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in participants with AD. Question 1 (Word Recall) and Question 7 (Word Recognition) of the ADAS-Cog questionnaire were summed to get a short term memory assessment score. Word recall task consist of the participants score was the mean number of words not recalled on three trials (maximum score 10) and word recognition task, to score this item the number of incorrect responses was counted (maximum error score was 12). The total score ranged from 0 to 22 with 0 indicating absence of symptoms and higher scores indicating greater dysfunction; a negative change from baseline indicated improvement. Change from Baseline in short term memory assessment was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 8, 16, 24, 36, 48 and 56|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1271543|NCT00348309|Secondary|Change From Baseline in Hematocrit Values|Blood samples of participants were collected for Hematocrit . Change from baseline in Hematocrit was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 8, 12, 16, 36 and 48|Safety population. Only those participants available at the specified time points were analyzed.|||litre||Standard Deviation|Mean
1271544|NCT00348309|Secondary|Change From Baseline in Hemoglobin Values|Blood samples of participants were collected for Hemoglobin. Change from baseline in Hemoglobin was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 16, 36 and 48|Safety population. Only those participants available at the specified time points were analyzed.|||grams per litre (g/L)||Standard Deviation|Mean
1271545|NCT00348309|Secondary|Mean Change From Baseline in Weight|Body weight was measured at all visits, without shoes and wearing light clothing. Mean Change From Baseline in Weight was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56|Safety population. Here, n=number of participants with observed data contributing to the analysis. Data for Site 040449 was not included in analysis due to audit finding.|||kilogram (kg)||Standard Deviation|Mean
1271546|NCT00348309|Secondary|Mean Change From Baseline in Heart Rate|Mean Change From Baseline in heart rate was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56|Safety population. Only those participants available at the specified time points were analyzed. Data for Site 040449 was not included in analysis due to audit finding.|||beats per min (bpm)||Standard Deviation|Mean
1271547|NCT00348309|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP)|The plethysmographic method was used to measure BP throughout the study. Change in Systolic and Diastolic BP was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56|Safety population. Only those participants available at the specified time points were analyzed. Data for Site 040449 was not included in analysis due to audit finding.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1271548|NCT00348309|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.|Up to Week 54|The safety population included all participants randomized to treatment and received at least one dose of study medication.|||Participants|||Number
1271549|NCT00348309|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48|Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Change from Baseline in HbA1c was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of total hemoglobin||Standard Error|Least Squares Mean
1271550|NCT00348309|Secondary|Change in CDR-SB Total Score at Week 54 Compared to Week 48|CDR-SB is a semi-structured interview of participants and their caregivers. Participant’s cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change was calculated as endpoint value (Week 54) minus Week 48 value.|Week 48 and 54|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1271551|NCT00348309|Secondary|Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48|ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change was calculated as endpoint value (Week 54) minus Week 48 value.|Week 48 and 54|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1271552|NCT00348309|Secondary|Change From Baseline in CDR-SB Score for Observed Cases at Weeks 12, 24, 36 and 48|CDR-SB is a semi-structured interview of participants and their caregivers. Participant’s cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline is calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 12, 24, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1271553|NCT00348309|Secondary|Change From Baseline in ADAS-Cog Total Score for Observed Cases at Weeks 8, 16, 24, 36 and 48|ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change from baseline is calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 8, 16, 24, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1271554|NCT00348309|Secondary|Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility|"The EQ-5D Proxy is a two part scale that evaluated the participant’s health status via Thermometer and Utility scores. The Thermometer score was the caregiver’s rating of the participant’s overall health status on a VAS (0 [“worst possible status”] to 100 [“best imaginable status”]). The Utility score was a caregiver rating of health status on dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression] where ‘1’ indicated better health state (no problems); ‘3’ indicated worst health state (confined to bed). Total possible score was the sum of individual items, ranged from 5 to 15; lower score indicated a better health state and higher score indicated greater severity of symptoms. A positive change from baseline indicated improvement in the Thermometer score and a negative change from baseline indicated improvement in the Utility score. Change from baseline is calculated as endpoint value minus the baseline value."|Baseline (Week 0), Week 12, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1271555|NCT00348309|Secondary|Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD)|The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented patients. RUD assessd both formal and informal resource use of the patient and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 corresponds to the number of hours during the last month the caregiver spent assisting the patient with toilet visits, eating, dressing, grooming, walking and bathing and Q2 corresponds to the number of hours during the last month the caregiver spent assisting the patient with shopping, food preparation, housekeeping, laundry, transportation, taking medication and managing financial matters. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented.|Baseline (Week 0), Week 12, 24, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||hours||Standard Error|Least Squares Mean
1282011|NCT00249249|Secondary|Apolipoprotein-A1 (Apo-A1)|Apolipoprotein-A1 at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||mg/dL||Standard Deviation|Mean
1271556|NCT00348309|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Total Score|The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. The scale was completed by the investigator, based on the performance of the participant, and took approximately 5 to 10 minutes to administer. The scores from 11 tests were combined to obtain the total score. The total scores range from 0 to 30, with lower scores indicating greater cognitive impairment and higher score indicating better outcome; a positive change from screening indicated an improvement. The total MMSE score for participants at screening was between 10 and 26, inclusive, in order to be eligible to participate in the trial. Change from screening is calculated as endpoint value minus the screening value.|Screening (Week -4) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1271557|NCT00348309|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. Change from baseline is calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 8, 16, 24 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1271558|NCT00348309|Secondary|Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The scale includes 23 items relating to instrumental activities of daily living and 17 items relating to basic self-care. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. Total score was obtained by adding the rating for each question and converting this total score out of 100. The total score ranged from 0 to 100, where higher score indicated better function and lower score indicated greater severity of symptoms; a positive change from baseline indicated an improvement. Change from baseline is calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 8, 16, 24 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1271559|NCT00348309|Primary|Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4|CDR-SB is a semi-structured interview of participants and their caregivers. Participant’s cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline is calculated as Week 48 value minus the baseline value. APOE4 negative, All except E4/E4’s: comprised of APOE4 negative and E4 heterozygote and full population was analyzed for this outcome measure. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1271560|NCT00348309|Primary|Change From Baseline in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 48|ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in participants with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change from baseline is calculated as Week 48 value minus the baseline value. APOE4 negative, All except E4/E4’s: comprised of APOE4 negative and E4 heterozygote and full population was analyzed for this outcome measure. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the genetic subgroups. Least square mean is entered for adjusted mean.|Baseline (Week 0) and Week 48|ITT population included all the participants who were randomized to treatment, who had received at least one dose of study medication and who had at least one post baseline efficacy assessment. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1271561|NCT00348283|Secondary|Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Weeks 12 and 52|ITT set. NRI method was used to impute the missing values.|||Subjects|||Number
1271562|NCT00348283|Secondary|Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52|The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at both Week 12 and Week 52.|Weeks 12 and 52|Analysis was on ITT subjects who completed the Double Blind period and had Week 52 evaluations while in the Double Blind period. NRI method was used to impute the missing values.|||Subjects|||Number
1271563|NCT00348283|Secondary|Number of Subjects With Clinical Remission (CDAI < 150) at Week 52|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Week 52|ITT set. NRI method was used to impute the missing values.|||Subjects|||Number
1271564|NCT00348283|Secondary|Number of Subjects Without Mucosal Ulceration at Week 52|The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at Week 52.|Week 52|The secondary efficacy analysis included the ITT subjects who had mucosal ulceration at screening. NRI method was used to impute the missing values.|||Subjects|||Number
1271565|NCT00348283|Secondary|Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12|Clinical remission is defined as a CDAI less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Week 12|ITT set. NRI method was used to impute the missing values.|||Subjects|||Number
1282012|NCT00249249|Secondary|Apolipoprotein B (Apo B)|Apolipoprotein B at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||mg/dL||Standard Deviation|Mean
1271566|NCT00348283|Primary|Number of Subjects Without Mucosal Ulceration at Week 12|Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or switched to OL adalimumab between Week 8 and Week 12 were to have undergone 3 endoscopies.|Week 12|Analysis was on ITT subjects with mucosal ulceration at Screening. Subjects who did not have endoscopy at Week 12 were considered to have mucosal ulceration at Week 12 (NRI). If subjects had endoscopy at Week 8, the endoscopy results from Week 8 were carried forward to Week 12 for the primary efficacy analysis.|||Subjects|||Number
1271567|NCT00348140|Secondary|Change From Baseline in Short Term Memory Assessment|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Questions 1 (word recall) and 7 (word recognition) of ADAS-Cog questionnaire was summed to get a short term memory assessment. The score for Question 1 was calculated as the mean number of words not recalled over the trials for which data was available. If data for all three trials was missing, or if the score for Question 7 was missing then the short term memory score will also be set to missing. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented.|Baseline (Week 0) and upto Week 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on an scale||Standard Error|Least Squares Mean
1271568|NCT00348140|Secondary|Change From Baseline in HbA1c up to Week 54|Blood samples were collected for assessments of HbA1c levels at Baseline, Weeks 12, 24, 36, 48, 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0.|Baseline (Week 0) and Weeks 12, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
1271569|NCT00348140|Secondary|Changes From Baseline in ECG Parameters- RR Interval, QT Interval, QTcB, QTcF, PR Interval and QRS Duration|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the participant had rested in the supine position in a quiet room (no TV, minimal talking) for atleast 10 minutes. The ECG parameters includes PR interval, QRS duration, QT – uncorrected interval, QTc Bazett (QTcB), QTc Fridericia (QTcF) and RR interval. The assessments were performed at Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.|||MSEC||Standard Deviation|Mean
1271570|NCT00348140|Secondary|Changes From Baseline in Electrocardiogram (ECG) Parameters- HR|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the participant had rested in the supine position in a quiet room (no TV, minimal talking) for atleast 10 minutes. The ECG parameters includes HR. The assessments were performed at Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value . Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Beats per minute (BPM)||Standard Deviation|Mean
1271571|NCT00348140|Secondary|Any Time on Treatment Differences in Frequencies of Clinical Chemistry Data Outside the Reference Range|Clinical chemistry parameters were identified as of PCC (High, Low), if values were out of RR: Alanine amino transferase (ALT,none-120 [250percent upper limit of RR, ULRR ]),Album in (0.75-2),Aldolase(1.1-1.1),Aspartate amino transferase (AST,none-105 (3-64y),137.5(65+y),>250 percent ULRR), Alkaline phosphatase(ALP,none-312.5 (20+y),>250percent ULRR),blood urea nitrogen(BUN)/Creatinine ratio(none-1.25),BUN(none-11),Chloride(80-115),Calcium (0.75-1.25),Carbon dioxide(CO2,15-40) content,Creatinine (22,<50percent lower limit of RR [LLRR ]-155, >125percent ULRR),Creatine phosphokinase(CPK,none-1.25),Gamma glutamyl transferase(GGT,none-2.5),Glucose (3.6-7.8),HbA1C, High density lipoprotein (HDL,0.65-none),Lactate dehydrogenase (LDH,none -2), Low density lipoprotein(LDL,none-1.25),Magnesium (0.5-2),Potassium (3-5.5),Phosphorus inorganic(0.5-1.5), Sodium (130-150), Total protein (0.8-1.5),Total cholesterol(none -1.5),Direct Billirubin.|Upto Week 48|Safety population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1271572|NCT00348140|Secondary|Any Time on Treatment Differences in Frequencies of Hematology Data Outside the Reference Range|Haematology parameters were identified as of PCC (high [H], low [L]), if the values were out of the reference range (RR). The range for parameters was: platelet (100AV-500AV), red blood cell (RBC , 0.8-1.2), hemoglobin (L: female [F]:10, male [M]:11; H: F:16.5–AV, M:18), hematocrit (0.8-1.2), white blood cell (WBC, 3-15), Total neutrophils (ANC- absolute Neutrophil count) (0.75-1.5), lymphocytes (0.75-1.5), monocyte s (0.75-2), eosinophils (none -2), basophils (none -2), mean corpuscle volume (MCV, 0.8-1.2), mean corpuscular hemoglobin (MCH, 0.8-1.2), mean corpuscular hemoglobin concentration (MCHC , 0.8-1.2), red cell distribution width (RDW, 0.8-1.2), Neutrophil bands (none-1) and segmented neutrophils (0.75-1.3). Full population data was presented.|Up to Week 48|Safety population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1271573|NCT00348140|Secondary|Change From Baseline in Hematocrit|Hematology parameters were assessed at Baseline and up to Week 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0.|Baseline (Week 0) and Weeks 4, 16, 36, 48|Safety population. Only those participants available at the indicated time points were analyzed.|||Ratio||Standard Deviation|Mean
1271574|NCT00348140|Secondary|Change From Baseline in Hemoglobin|Hematology parameters were assessed at Baseline, Weeks 4, 16, 36, 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 16, 36, 48|Safety population. Only those participants available at the indicated time points were analyzed.|||Gram\Liter (G\L)||Standard Deviation|Mean
1271575|NCT00348140|Secondary|Change From Baseline in Weight|Body weight was measured at all visits, without shoes and wearing light clothing. The assessment was performed at Baseline, Weeks 4, 8, 12, 16, 24, 36, 48, 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 12, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Kilograms (Kg)||Standard Deviation|Mean
1271576|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Heart Rate (HR)|HR of participants were recorded in sitting posture as vital sign at each visit. The HR values were identified as of potential clinical concern if the values were out of the reference range (50 to 100 beats per minute) or meet a change from baseline criterion. The change from baseline criterion for HR, was increase from Baseline (high) if increased by more than or equal to (>=) 30 from Baseline; decrease from Baseline (low) if decreased by >= 30 from Baseline. Baseline was defined as value at Week 0. Full population data was presented.|Upto Week 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1271577|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP of participants were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the values were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from baseline criterion. The change from baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mm Hg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase from baseline (high) if increased by >=30 mmHg from baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. Baseline was defined as value at Week 0.|Upto Week 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1271578|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Weight|Body weight was measured at all visits, without shoes and wearing light clothing. The assessment was performed a t Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Upto Week 54|Safety population. Only those participants available at the indicated time point were analyzed.|||Participants|||Count of Participants
1271579|NCT00348140|Secondary|Number of Participants With On-treatment Adverse Events (AEs), Serious Adverse Events (SAEs) and Severity of AEs|AE was defined as any untoward medical occurrence in a participant temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that, at any dose results in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was considered as medically significant.|Upto Week 48|Safety population consisted of all participants randomized to treatment who had taken at least one dose of study medication. This population was used for analysis of safety data.|||Participants|||Count of Participants
1271580|NCT00348140|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48|Blood samples were collected for assessments of HbA1c levels at Baseline and up to Week 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value . Baseline was defined as value at Week 0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Full population data was presented.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at that particular time point were analyzed.|||Percentage||Standard Error|Least Squares Mean
1271581|NCT00348140|Secondary|Change in CDR-SB Total Score for Observed Cases at Week 54 Compared to Week 48|The CDR-SB was a validated clinical assessment of global function in participants with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). It was of interest to compare the single blind phase data between the treatment groups defined based on the double blind treatment group. This analysis only included participants who received at least one dose of single-blind medication. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Week 48 and Week 54|ITT population. Only those participants available at that particular time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1271582|NCT00348140|Secondary|Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. It was of interest to compare the single blind phase data between the treatment groups defined based on the double blind treatment group. This analysis only included participants who received at least one dose of single-blind medication. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Week 48 and Week 54|ITT population. This analysis will only include participants who received at least one dose of single-blind medication. Only those participants available at that particular time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1271590|NCT00348140|Secondary|Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36|The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. It was calculated at Weeks 12, 24 and 36. Full population data was presented.|Baseline (Week 0) and Week 12, 24, 36|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1271583|NCT00348140|Secondary|Change From Baseline in Alzheimer’s Carer’s Quality of Life Instrument (ACQLI) Score|The ACQLI is an assessment of caregiver quality of life. This instrument consisted of 30 questions exploring various aspects of carer’s quality of life. Each of the questions had two point response, and the 30 questions were summed to provide a total score. Items were assumed to be unidimensional (i.e., represent a single variable) and were scored 0/1 (false/true) before summation into a total score with a 0–30 range. To ease comparisons between scales, ACQLI scores were transformed to range between 0–100 (100: worse). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1271584|NCT00348140|Secondary|Change From Baseline in EQ-5D Scale Total Score- Utility Score|The EQ-5D Proxy is an assessment of quality of life and utility benefit. The EQ-5D Proxy is composed of two parts: part one is the five dimensional Health State Classification. The Utility score is a caregiver rating of health status on dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Answers to each question were responded to on a 3-point scale which indicates the level of impairment (level 1= no problem; level 2=some or moderate problem(s) and level 3=unable, or extreme problem with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1271585|NCT00348140|Secondary|Change From Baseline in European Quality of Life -5 Dimensions (EQ-5D) Scale Total Score- Thermometer Score|The EQ-5D Proxy is an assessment of quality of life and utility benefit. The EQ-5D Proxy is composed of two parts: part two is the visual analogue scale ‘Thermometer’. Caregivers are asked to respond as they feel the participant would on dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 'Thermometer' has endpoints of 100 (best imaginable health state) and 0 (worst imaginable health state). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1271586|NCT00348140|Secondary|Change From Baseline in Domains of the Resource Utilization in Dementia Scale (RUD)- Q1 and Q2 Caregiver Hours|The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented patients. RUD assessd both formal and informal resource use of the patient and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 corresponds to the number of hours during the last month the caregiver spent assisting the patient with toilet visits, eating, dressing, grooming, walking and bathing and Q2 corresponds to the number of hours during the last month the caregiver spent assisting the patient with shopping, food preparation, housekeeping, laundry, transportation, taking medication and managing financial matters. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 24, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Caregiver hours||Standard Error|Least Squares Mean
1271587|NCT00348140|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|NPI is an assessment of frequency and severity of behavioral disturbances in dementia that comprised of 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety, aberrant motor activity. Participant’s caregiver asked about behavior in participant. If “Yes”, informant then rated both severity on a 3-point scale, 1-mild to 3-severe (total range: 0-36) and frequency using a 4-point scale, 1-occasionally to 4-very frequently. Total score was frequency × severity. Distress was scored on 5-point scale, 0-no distress to 5-very severe or extreme. Total NPI score was calculated by adding all domain scores; NPI total score: 0-144 and NPI distress score: 0-60, higher scores indicated more severe behavioral disturbance. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 8, 16, 24, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1271588|NCT00348140|Secondary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score|The DAD assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assessed a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD Total score /Total number of applicable items) multiplied by 100. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Week 8, 16, 24, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1271589|NCT00348140|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Total Score|The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale is completed by the investigator, based on the performance of the participant. Change from screening was calculated as value at scheduled time point minus screening value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Screening (Week -4) and Week 48|ITT population. Only those participants available at that particular time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1271591|NCT00348140|Secondary|Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. It was calculated at Weeks 8, 16, 24 and 36. Full population data was presented.|Baseline (Week 0) and Week 8, 16, 24, 36|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1271592|NCT00348140|Primary|Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort|The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
1271593|NCT00348140|Primary|Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort|The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
1271594|NCT00348140|Primary|Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort|The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or “box scores”, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
1271595|NCT00348140|Primary|Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
1271596|NCT00348140|Primary|Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
1271597|NCT00348140|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population comprised of all participants randomized to treatment, who had taken at least one dose of study medication and who had at least one post baseline efficacy assessment. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
1271598|NCT00347958|Other Pre-specified|Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®|Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.|Day 28 post-vaccination|Tetanus and diphtheria antibody analyses were in all enrolled and vaccinated participants in the per-protocol population. Diphtheria antibody titers were analyzed separately for participants without and with an intervening Menactra vaccination between the previous study and Study Td518.|||Percentage of Participants|||Number
1271599|NCT00347958|Other Pre-specified|Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.|Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1271600|NCT00347958|Other Pre-specified|Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.|Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1271601|NCT00347958|Primary|Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination|Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.|0-14 days post-vaccination|"Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.~The solicited systemic reaction, malaise was not collected in the previous studies."|||Percentage of Participants|||Number
1271602|NCT00347932|Secondary|Microbial Eradication of Baseline Bacterial Infection|Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.|Day 8 or 9|Modified intent to treat population, culture confirmed, as randomized.|||Participants|||Number
1271603|NCT00347932|Secondary|Clinical Resolution of Baseline Bacterial Conjunctivitis|The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection|Day 8 or 9|Modified intent to treat population, culture confirmed, as randomized|||Participants|||Number
1271604|NCT00347932|Primary|Microbial Eradication of Baseline Bacterial Infection|Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.|Day 5 +/- 1 day|Modified Intent to treat population, culture confirmed, as randomized.|||Participants|||Number
1271605|NCT00347932|Primary|Clinical Resolution of Baseline Bacterial Conjunctivitis|The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection|Day 5 +/- 1 day|Modified intent to treat population, culture confirmed, as randomized|||Participants|||Number
1271606|NCT00347919|Secondary|Percentage of Participants With Progressive Disease at Week 12|The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Participants were classified as having PD if their response at Week 12 was unknown or missing. Per Response Evaluation Criteria In Solid Tumors (RECIST), PD is defined as a >=20% increase in target lesions. IRC, independent review committee.|Week 12|Cohort 2 MITT Population|||percentage of participants|||Number
1271607|NCT00347919|Secondary|Time to Response (Complete or Partial Response) in Cohort 1 and Cohort 2|Time to response is defined as the time from randomization to the time of first documented evidence of a complete (CR) or partial response (PR). The time to response will depend on when the response is counted as starting. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the target dimensions of the target lesions taking as a reference the baseline sum.|The time from randomization to the time of first documented evidence of complete or partial response (up to 81.14 weeks for Cohort 1 and 44.29 weeks for Cohort 2)|MITT Population|||weeks||95% Confidence Interval|Median
1271608|NCT00347919|Secondary|Duration of Response in Cohort 1|Duration of response is defined as the length of time from the time from the first observation of response until progression of disease or death. Duration of response depends on two things: (1) when response is counted as starting; (2) when response is counted as ending.There were insufficient data to adequately assess duration of response for Cohort 2. IRC, independent review committee. For participants who do not progress or die, duration of response was censored at the date of last adequate assessment.|Time from first documented evidence of complete or partial response until the first documented sign of disease progression or death due to any cause (up to 106.71 weeks)|MITT Population|||weeks||Inter-Quartile Range|Median
1271609|NCT00347919|Secondary|Response at Week 12 for Cohort 1 and Cohort 2|The percentage of participants achieving either a complete (CR) or partial (PR) tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) is presented. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee. Participants with an unknown or missing response were treated as non-responders.|Week 12|MITT Population|||percentage of participants|||Number
1271610|NCT00347919|Secondary|Overall Survival for Cohort 1|Overall survival (OS) is defined as the time from randomization until death due to any cause. Participants who are alive as of the date of last contact are censored. There was insufficient follow-up to adequately assess OS for Cohort 2. Median OS cannot be presented for the lapatinib arm because the upper bound of the 95% confidence interval is undefined due to insufficient follow-up.|Randomization until death due to any cause (up to 106.43 weeks)|MITT Population|||weeks||95% Confidence Interval|Median
1271611|NCT00347919|Primary|Percentage of Participants With Progressive Disease at Week 12 in Cohort 1|The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.|Week 12|Cohort 1: Modified Intent-to-Treat (ITT) Population (all randomized, centrally confirmed, ErbB2 FISH-positive participants).|||percentage of participants|||Number
1271612|NCT00347776|Secondary|Adverse Events|At 6 weeks participants/family members were asked about any hospitalization,death,ocular complaints, gastrointestinal illness or other specific illness or any clinic visit within six weeks of receiving surgery.|6 weeks||||Participants|||Count of Participants
1271613|NCT00347776|Secondary|Surgical Failure|The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.|6 weeks||||Participants|||Count of Participants
1271614|NCT00347776|Primary|Recurrent Trichiasis Between Two Azithromycin Arms|"Recurrence of trichiasis :Clinical assessment for recurrence was done by looking for one or more eye lashes touching globe or evidence of epilation.~If there was evidence of epilation or if one or more eye lashes were touching the globe, it was considered as recurrence of trichiasis."|Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery||||Participants|||Count of Participants
1271615|NCT00347776|Primary|Recurrent Trichiasis in Tetracycline and Azithromycin Groups|Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.|Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery|Recurrence rates (expressed as person-years) in the tetracycline arm was compared with the 2 azithromycin arms combined (483+ 485= 968 participants)|||Participants|||Count of Participants
1271616|NCT00347438|Primary|Complete Pathologic Response Rate (cPR)|Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.|||percentage of participants|||Number
1271617|NCT00347438|Primary|Complete Clinical Response Rate (CCR)|Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.|||percentage of participants|||Number
1271618|NCT00347438|Primary|Partial Clinical Response Rate (PR)|Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.|||participants|||Number
1271619|NCT00347438|Primary|Overall Clinical Response Rate (OCR)|Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.|||percentage of participants|||Number
1271620|NCT00347360|Secondary|Diastolic Responders, Defined as ≥ 10 mmHg Sitting (s)DBP Reduction From Baseline or a sDBP of <90 / 80 Millimeters (mm) of Mercury (Hg) for Non Diabetic / Diabetic Subjects Respectively (Based on Cuff Trough Measures)||Week 6|ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.|||participants|||Number
1271621|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment|Analysis of Change from Baseline to Week 6 in Mean sSBP and sDBP by Cuff Assessments at Drug Trough (20-24 hr) at End of Treatment Titration|Baseline, Week 6|ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.|||mmHg||Standard Deviation|Mean
1271622|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM|Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the night. The night-time assessment period started at the time of the first reading at or after 6 pm and ended immediately before 6 am on the following day.|Night BP, Baseline, Week 6|: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
1271623|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM|Mean changes from Baseline to Week 6 in SBP and DBP measured by 24hr ABPM at the end of up-titration recorded in the afternoon. The afternoon assessment period started at or after 12 noon and ended immediately before 6 pm.|Afternoon BP, Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
1271624|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM|Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the morning. The morning assessment period started at or after 6 am and ended immediately before 12 noon.|Morning BP, Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
1271625|NCT00347360|Secondary|Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates.|Refer to Adverse Event section for safety information.|Weeks 1 through 48|||||||
1271675|NCT00346632|Secondary|Observed Peak Plasma Concentration (Cmax)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1||||ng/mL||Standard Deviation|Mean
1271626|NCT00347360|Secondary|Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring)|Trough (20-24 hr) to peak (3-7 hr) ratios of DBP were examined in order to evaluate the extent to which once-daily criteria were met (ie trough:peak > 50%). Trough to peak ratios were calculated from change trough mean/change peak mean x 100.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||trough:peak ratio x 100%|||Number
1271627|NCT00347360|Secondary|Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring)|Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Error|Mean
1271628|NCT00347360|Secondary|Change From Baseline to Week 6 in Trough Systolic Blood Pressure|Trough ABPM was the average across 20-24 hr after dosing for each subject.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
1271629|NCT00347360|Secondary|Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure|Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean systolic blood pressure (SBP).|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
1271630|NCT00347360|Primary|Change From Baseline to Week 6 in Trough Diastolic Blood Pressure|Trough ABPM was the average across 20-24 hr after dosing for each subject.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
1271631|NCT00347360|Primary|Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure|Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).|Baseline, Week 6.|ABPM Population with Last Observation Carried Forward (LOCF): This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population.|||mmHg||Standard Deviation|Mean
1271632|NCT00347308|Primary|Eyebrow Position|Position of eyebrow at the medial canthus relative to orbital rim|At time of evaluation||||mm||Standard Deviation|Mean
1271633|NCT00347269|Secondary|Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9||Measured at Month 18|||||||
1271634|NCT00347269|Primary|BSI-12 (Anxiety and Somatization Subscales)|12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms|Measured at Month 18||||number of responders|||Number
1271635|NCT00347022|Primary|Creatinine Clearance|The variation of creatinine clearance before and after the product injection was measured|between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration||||percent change||Standard Deviation|Mean
1271636|NCT00347009|Primary|Number of Participants With Histologic Improvement at Month 36 (Per Protocol Population)|The Ishak fibrosis score is a scoring system (ranging from 0 to 6) that measures the degree of fibrosis (scarring) of the liver, which is caused by chronic necroinflammation (an inflammatory process in the liver including or leading to death of liver cells). A score of 0 represents no fibrosis, and a score of 6 represents established cirrhosis. Participants were classified as improved if the Ishak fibrosis score at Month 36 was 1 or more points less from the Screening score.|Screening and Month 36|Per Protocol (PP) Population: all participants in the ITT Population with interpretable liver biopsies at baseline and at the 36-month follow-up visit and without major violations of the protocol|||participants|||Number
1271637|NCT00347009|Secondary|Number of Participants Who Were HBsAg Positive at Baseline, With HBsAg Seroconversion at Months 12, 24, and 36|HBsAg seroconversion was defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb).|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
1271638|NCT00347009|Secondary|Number of Participants Who Were Hepatitis B Surface Antigen (HBsAg) Positive at Baseline and Developed Undetectable Levels of HBsAg at Months 12, 24, and 36|HBsAg positive was defined as the presence of a detectable level of HBsAg.|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
1271639|NCT00347009|Secondary|Number of Participants Who Were HBeAg Positive at Baseline, With HBeAg Seroconversion at Months 12, 24, and 36|HBeAg seroconversion was defined as a decrease in HBeAg to undetectable levels and a gain of detectable levels of Hepatitis B envelope antibody (HBeAb).|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
1271640|NCT00347009|Secondary|Number of Participants Who Were Hepatitis B Envelope Antigen (HBeAg) Positive at Baseline and Developed Undetectable Levels of HBeAg at Months 12, 24, and 36|HBeAg positive was defined as the presence of a detectable level of HBeAg.|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
1271721|NCT00346164|Primary|Probability for Event Free Survival.|Probability of no relapse, secondary malignancy or death after 5 years since enrollment.|5 years|Ineligible patients are excluded as well as patients who were treated on the incorrect arm.|||Probability of EFS at 5 years||95% Confidence Interval|Number
1271641|NCT00347009|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Months 12, 24, and 36|ALT levels were measured as part of the liver function tests. Participants with ALT normalization at each visit were defined as those with a value below the upper limit of the normal (ULN) range for ALT provided by that site at the respective visit.|Months 12, 24, and 36|ITT Population|||participants|||Number
1271642|NCT00347009|Secondary|Number of Participants With Virological Breakthrough at Months 12, 24, and 36|Virological breakthrough was defined as an increase in serum HBV DNA levels by more than 1 log10 copies/ml from treatment nadir, i.e., the lowest HBV DNA value during the study.|Months 12, 24, and 36|ITT Population|||participants|||Number
1271643|NCT00347009|Secondary|Number of Participants With Undetectable HBV DNA at Months 12, 24, and 36|Undetectable HBV DNA was defined as an HBV DNA level below the lower limit of detection (LLOD) of 300 copies/ml.|Months 12, 24, and 36|ITT Population|||participants|||Number
1271644|NCT00347009|Secondary|Number of Participants Achieving Virological Response (HBV DNA Level <= 10^4 Copies/ml) at Months 12, 24, and 36|Virological response was defined as an HBV DNA level <= 10^4 copies/ml.|Months 12, 24, and 36|ITT Population|||participants|||Number
1271645|NCT00347009|Secondary|Number of Participants Achieving Virological Response (HBV DNA Level <= 10^3 Copies/ml) at Months 12, 24, and 36|Virological response was defined as an HBV DNA level <= 10^3 copies/ml.|Months 12, 24, and 36|ITT Population|||participants|||Number
1271646|NCT00347009|Secondary|Change From Baseline in Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level at Months 12, 24, and 36|The levels of HBV DNA in serum were measured using the Amplicor Cobas assay by Roche Diagnostics (detection limit 300 copies/milliliter [ml]). Changes from baseline in the serum HBV DNA level at Months 12, 24 and 36 were calculated as Month 12 minus baseline, Month 24 minus baseline, and Month 36 minus baseline respectively. Change is reported in log10 units.|Baseline and Months 12, 24, and 36|ITT Population|||log10 copies/ml||Standard Deviation|Mean
1271647|NCT00347009|Secondary|Number of Participants With a Reduction From Screening of at Least 2 Points in the Knodell Necroinflammation Score at Month 36|The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) periportal and/or bridging necrosis (scores from 0 to 10); (II) intralobular degeneration and focal necrosis (scores from 0 to 4); (III) portal inflammation (scores from 0 to 4); (IV) fibrosis (scores from 0 to 4). The Knodell necroinflammation score is the sum of scores from Parts I-III, hence a range of 0 to 18, and measures the degree of acute necroinflammatory activity in the liver.|Screening and Month 36|ITT Population|||participants|||Number
1271648|NCT00347009|Secondary|Number of Participants With a Reduction From Baseline in the Child-Pugh Score by 2 Points or More at Months 12, 24, and 36|The Child-Pugh score (modified version for scoring prothrombin time against reference range) was used in the study to assess the prognosis of chronic liver disease, mainly cirrhosis. The score employs five clinical measures of liver disease: encephalopathy, ascites, albumin, prothrombin time, and bilirubin. Each measure is scored on a scale of 1-3, with 1 being normal and 3 indicating most severe derangement. The total score for the Child-Pugh assessment was calculated as the sum of the 5 contributing scores, with a score range of 5 (best prognosis) to 15 (worst prognosis).|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
1271649|NCT00347009|Primary|Number of Participants With Histologic Improvement at Month 36 (Intent-to-Treat Population)|The Ishak fibrosis score is a scoring system (ranging from 0 to 6) that measures the degree of fibrosis (scarring) of the liver, which is caused by chronic necroinflammation (an inflammatory process in the liver including or leading to death of liver cells). A score of 0 represents no fibrosis, and a score of 6 represents established cirrhosis. Participants were classified as improved if the Ishak fibrosis score at Month 36 was 1 or more points less from the Screening score.|Screening and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication, regardless of whether the participants completed the planned duration of the study|||participants|||Number
1271650|NCT00346905|Primary|Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients.|Clinically significant reduction of PPI usage is defined as either elimination of medication use or reduction in dosage of ≥50% as compared to baseline. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction.|3 years either baseline to 12m, baseline to 24m, baseline to 36m|Overall Number of Participants Analyzed (16) will differ at 12m, 24m, and 36m intervals due to patients who were available at the given follow-up interval.|||% of Participants|||Number
1271651|NCT00346775|Secondary|Number or Participants With Preference of Nasal Sprays (Nasarel or Beconase AQ) at the End of the Last Cross-over Period Using the Preference Module of the EARNS-Q|The participants with preference of nasal sprays (Nasarel or Beconase AQ) at the end of the last cross-over period was planned to be analyzed using the preference module of the EARNS-Q. The data for this outcome measure was not collected and the result summary was not generated.|Up to Day 23|Efficacy Population. No participants were analyzed for this outcome measure.||||||
1271652|NCT00346775|Secondary|Mean rTNSS Over Period|The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a 4 point scale ranging from 0 to 3. Each individual symptom was evaluated using a scale of 0 (none; symptom is not present), 1 (mild; sign/symptom clearly present but minimal awareness; easily tolerated), 2 (moderate; definite awareness of sign/symptom that is bothersome but tolerable), or 3 (severe; sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The rTNSS ranges from 0 (none) to 12 (severe). Higher score represents greater severity of symptoms. The reflective assessment of the TNSS scores the four nasal symptoms over the previous 12 hours and are assessed in the morning and evening. The participants themselves scored nasal symptoms in a diary card. The analysis was done based on the rTNSS averaged over the two weeks of the treatment period.|Day 1 to 8 of each treatment period|Efficacy population was defined as all participants who completed both treatment periods, who had efficacy and questionnaire data recorded in both treatment periods, and who had recorded sufficient efficacy data to calculate daily rTNSS.|||Score on scale||Standard Error|Least Squares Mean
1271722|NCT00346151|Secondary|Proportion of Participants With Post-transplant Diabetes Mellitus||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
1271653|NCT00346775|Primary|Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores|The 28 items of the EARNS-Q experience module assess 14 attributes with regard to their product rating and their importance of efficacy, SP, DC and SD. The EARNS-Q preference module consists of additional 15 items that evaluate preference by comparing two products based on the same 14 experience attributes as well as on OPP. Change in EARNS-Q Experience Module domain scores was calculated as scores in TP2 minus scores in TP1. If the change in EARNS-Q Experience Module domain scores is +ve, product in TP2 is preferred and vice-versa. A higher product rating for one of the sprays lead to a preference for that spray. The EARNS-Q preference module was assessed only once, at the end of TP2. Positive correlations indicate agreement (i.e. preference for a product is positively associated with better experience with same product).|Day 1 to Day 23|ITT Population. Pearson correlations was used in correlational analyses.|||correlation coefficient|||Number
1271654|NCT00346775|Primary|Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores|EARNS-Q Preference Module consists of efficacy, sensory perception (SP), device characteristic (DC), spray delivery (SD), overall product preference (OPP) and total domain. TSQM consists of global satisfaction (GS), convenience, effectiveness and side-effects (SE) domains. Positive (+ve) correlation of EARNS-Q preference scores with change on TSQM domains indicate that preference for a product is associated with better TSQM scores. Negative (-ve) correlation with mean daily rTNSS indicate that preference for a product is associated with lower mean daily rTNSS. Change in TSQM domain scores and mean daily rTNSS was calculated as scores in Treatment Period (TP) 2 minus scores in TP1; change in TSQM is +ve, product in TP2 is preferred, vice-versa; change in rTNSS is -ve, product administered in TP2 is preferred, vice-versa.|Day 1 to Day 23|Intent- to- Treat (ITT) Population was defined as all the participants who were randomized to the study drug. Pearson correlations was used in correlational analyses.|||correlation coefficient|||Number
1271655|NCT00346697|Secondary|Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||seconds||Inter-Quartile Range|Median
1271656|NCT00346697|Secondary|Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||seconds||Inter-Quartile Range|Median
1271657|NCT00346697|Secondary|Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||mcg/L||Inter-Quartile Range|Median
1271658|NCT00346697|Secondary|Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||ng/mL||Inter-Quartile Range|Median
1271659|NCT00346697|Secondary|Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||pg/mL||Inter-Quartile Range|Median
1271660|NCT00346697|Secondary|Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||pg/mL||Inter-Quartile Range|Median
1271661|NCT00346697|Secondary|Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||pg/mL||Inter-Quartile Range|Median
1271662|NCT00346697|Secondary|Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||pg/mL||Inter-Quartile Range|Median
1271663|NCT00346697|Secondary|Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||ng/ml||Inter-Quartile Range|Median
1271664|NCT00346697|Secondary|Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|Analysis done on all participants with available data|||cells/cc||Inter-Quartile Range|Median
1271665|NCT00346697|Secondary|Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|Analysis done on all participants with available data|||units on a scale||Inter-Quartile Range|Median
1271666|NCT00346697|Secondary|Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks||||mg/dl||Inter-Quartile Range|Median
1271667|NCT00346697|Secondary|Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks||||mg/dl||Inter-Quartile Range|Median
1271668|NCT00346697|Secondary|Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks||||mg/dl||Inter-Quartile Range|Median
1271669|NCT00346697|Primary|Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks||||mg/dl||Inter-Quartile Range|Median
1271670|NCT00346632|Secondary|Disease Response|"Disease response (i.e., complete or partial remission) based on standard criteria:~Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-4649.~Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-3674.~VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Criteria for use of Imatinib Mesylate (Gleevec®) [updated March 2002; cited 2005 Nov 16]. Available from: http://www.pbm.va.gov/archive/imatinibcriteria.pdf"|Day 14 (Arm A) or Day 28 (Arm B) for all cycles||||number of responders|||Number
1271671|NCT00346632|Secondary|Accumulation Ratio (AUC 0-tau Day 14 or 28 / AUC 0-tau Day 1)||Day 1 and either Day 14 or Day 28 of Cycle 1||||Ratio of hr*ng/mL||Standard Deviation|Mean
1271672|NCT00346632|Secondary|Terminal Half Life (t 1/2)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1||||hours||Standard Deviation|Mean
1271673|NCT00346632|Secondary|Area Under the Plasma Concentration-time Curve From 0 to Tau (AUC (0-tau, Tau is the Dosing Interval))||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1||||hr*ng/mL||Standard Deviation|Mean
1271674|NCT00346632|Secondary|Time to Peak Plasma Concentration (Tmax)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1||||hours||Standard Deviation|Mean
1271676|NCT00346632|Primary|Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0|In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.|Baseline up to Cycle 2, Day 1||||participants|||Number
1271677|NCT00346476|Primary|Number of Participants With HIV Infection||At Year 5||||participants|||Number
1271678|NCT00346476|Secondary|Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants||At Year 5|||||||
1271679|NCT00346476|Secondary|Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants||Year 1 to Year 5|||||||
1271680|NCT00346476|Secondary|Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART||Year 1 to Year 5|||||||
1271681|NCT00346476|Secondary|Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants||Year 1 to Year 5|||||||
1271682|NCT00346476|Primary|Number of Participants With Microbiologically Confirmed Tuberculosis Infection||At Year 5||||participants|||Number
1271683|NCT00346398|Secondary|Time to First Onset of Asthma|Time to first onset of asthma is the time from the day a participant is randomized and initiates study treatment to the diagnosis of the first of three episodes of asthma. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze.|From Treatment Initiation to Month 36 Status Post Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial|||Months||Standard Error|Mean
1271684|NCT00346398|Secondary|Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion|Participants who currently have asthma three years after end of treatment. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze. Current asthma is defined as a diagnosis of asthma and at least one episode of wheeze lasting 3 or more consecutive days in the past 12 months.|Three years (36 months) after Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial|||participants|||Number
1271685|NCT00346398|Primary|Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion|"Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test[1] or a positive allergy skin prick test[2]. Not experiencing allergic sensitization is the better outcome for this measure.~A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result >= 0.35 kU/L. Higher scores indicate greater allergic sensitization.~A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by a negative control. Higher wheal sizes indicate greater allergic reaction or sensitization."|Three years (36 months) after Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial|||participants|||Number
1271686|NCT00346333|Secondary|Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity|Annual change in number of letters read.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis and included all reliable, non-missing values. The unit of analysis was the eye.Each patient contributed 2,1, or 0 eyes with non-missing data.|||Change in letters read per year||Standard Error|Mean
1271687|NCT00346333|Secondary|Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period.|Computer averaged 30 Hz ERG amplitudes in microvolts for those with initial amplitudes of >= 0.68 microvolts. Presented on the ln scale.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis;analyses of 30 Hz ERG data included those who had an initial amplitude of 0.68 microvolts or greater in at least 1 eye and data were censored when values declined to less than 0.34 microvolts. The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.|||ln (microvolts)/year||Standard Error|Mean
1271688|NCT00346333|Secondary|Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer.|Sum of visual field sensitivity readings in dB to a size V target obtained with the 30-2 and 60-4 programs of the Humphrey Field Analyzer combined for those patients on whom both measures were available.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis. A total field was calculated for each eye using the 30-2 and 60-4 conditions after applying the eligibility criteria for each component. Total field for a given eye was not calculated if either was missing. The unit of analysis was the eye.Each patient contributed 2, 1, or 0 eyes with non-missing data.|||annual change in dB vf sensitivity||Standard Error|Mean
1271689|NCT00346333|Secondary|Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.|Sum of visual field sensitivity readings in dB to a size V target from the 30 degree meridian to the 60 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis;lower sample sizes for this endpoint reflect instances where test results were not available for this outcome variable.The ability to perform this test was not a criterion for study entry.Eyes with an initial score ≥ 10 were included. Values were set to zero for all visits after an initial value of zero.|||annual change in dB vf sensitivity||Standard Error|Mean
1271690|NCT00346333|Primary|Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).|Sum of visual field sensitivity readings in decibel(dB) to a size V target out to the 30 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.|assessed at each of 4 annual visits after baseline|Intention to treat analysis;sample of 215 patients with all 4 years of followup and reliable, non missing data at all 4 years was analyzed. Eyes with an initial 30-2 total point score >= 250 dB were included.The eye was the unit of analysis. Each patient contributed 2,1, or 0 eyes with non-missing data.|||annual change in db vf sensitivity||Standard Error|Mean
1271691|NCT00346268|Other Pre-specified|Total Amount of Postoperative Drainage Fluid|After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.|24 hours post surgery|Data not analyzed due to study termination.|||mL|||Number
1271692|NCT00346268|Other Pre-specified|Hemoglobin Concentration||24 hours post surgery|Data not analyzed due to study termination.|||g/dL|||Number
1271693|NCT00346268|Other Pre-specified|Overall Analgesic Benefit Score (OABS)|Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.|24 and 48 hours post surgery|Data not analyzed due to study termination.|||scores on a scale|||Number
1271694|NCT00346268|Other Pre-specified|Number of Participants With Health Care Resource Utilization (HCRU)|"Supervising physician or nurse answered question in the presence of participant, In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist."|24 and 48 hours post surgery|Data not analyzed due to study termination.|||participants|||Number
1271695|NCT00346268|Other Pre-specified|Number of Participants With Rating of Global Evaluation of Study Medication|"Participants asked, “How would you rate the study medication you received for pain since your surgery? choices included: Poor, Fair, Good, and Excellent."|48 hours post surgery|FAS; N=participants with evaluable data.|||participants|||Number
1271696|NCT00346268|Secondary|Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score|Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms’ OR-SDS scores; ranged from 1 to 4.|24 and 48 hours post surgery|FAS; N=participants with evaluable data.|||scores on scale||Standard Deviation|Mean
1271697|NCT00346268|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score|mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.|24 and 48 hours post surgery|FAS; N=participants with evaluable data; n=participants with evaluable data for specified category; for analyses, missing values imputed using LOCF method.|||scores on a scale||Standard Deviation|Mean
1271698|NCT00346268|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score|mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).|24 and 48 hours post surgery|FAS; N=participants with evaluable data; n=participants with evaluable for specified category; for analyses, missing values imputed using Last-Observation-Carried-Forward (LOCF) method.|||scores on a scale||Standard Deviation|Mean
1271699|NCT00346268|Secondary|Pain Intensity Score|"Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).~Movement defined as sitting up from a lying into a sitting position in bed."|12, 24, 36, and 48 hours post surgery|FAS; N=participants with evaluable data|||scores on a scale||Standard Deviation|Mean
1271700|NCT00346268|Secondary|Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units||48 hours post surgery|FAS|||participants|||Number
1271701|NCT00346268|Secondary|Amount of Blood Loss|Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.|48 hours post surgery|FAS|||g/dL||Standard Deviation|Mean
1271702|NCT00346268|Secondary|Time to Last Administration of Morphine|Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).|baseline (end of surgery) to 48 hours post surgery|FAS; Number of participants analyzed (N)=participants with evaluable data|||hours||Full Range|Median
1271703|NCT00346268|Secondary|Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery|Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.|48 hours post surgery|FAS|||mL||Standard Deviation|Mean
1271704|NCT00346268|Primary|Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery|Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.|24 hours post surgery|Full Analysis Set Population (FAS): participants who were randomized to treatment|||mL||Standard Deviation|Mean
1271705|NCT00346216|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain (VAS)|"VAS question How much pain do you have was graded on a scale from 0 to 100 with 0 indicating No pain and 100 indicating Worst possible pain."|ITT and MITT Population - Baseline to 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."|||Number of participants||Standard Deviation|Mean
1271723|NCT00346151|Secondary|Proportion of Participants With Delayed Graft Function||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
1271724|NCT00346151|Secondary|Proportion of Participants With Chronic Allograft Nephropathy||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
1271706|NCT00346216|Secondary|The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)|CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer|ITT Population - 30 months; MITT Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."|||Percentage of Participants|||Number
1271707|NCT00346216|Secondary|The First Occurrence of a Major Adverse Cardiovascular Events (MACE)|MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA|ITT Population - 30 months; MITT Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."|||Percentage of Participants|||Number
1271708|NCT00346216|Primary|The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).|APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).|Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."|||Percentage of Partcipants|||Number
1271709|NCT00346164|Secondary|Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems|POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.|At diagnosis|Ineligible patients, as well as patients without histologic grade determined by POG or FNCLCC were excluded. The OM evaluates the degree of agreement of two pathology grading systems applied at diagnosis. The time frame “At diagnosis” reflects the OM.|||Participants|||Count of Participants
1271710|NCT00346164|Secondary|Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers|Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.|At Diagnosis|Ineligible patients, as well as patients without histologic grade determined by enrolling institution or central pathology reviewers were excluded. The OM evaluates the degree of agreement of two pathology grading reviews at diagnosis. The time frame “At diagnosis” reflects the OM.|||Participants|||Number
1271711|NCT00346164|Secondary|Genetic and Gene Expression Profiles|The tumors from patients registered on D9902 will be analyzed for genetic and gene expression profiles. The study will prospectively evaluate each tumor and confirm newly defined sarcoma diagnostic criteria based on cancer signatures in NRSTS.|At diagnosis|None of the tumors were analyzed for genetic and gene expression profiles. The analysis will not be completed. The time frame “At diagnosis” is the time frame for the gene expression profiles.||||||
1271712|NCT00346164|Secondary|Incidence of Distant Metastasis|Percent of patients who had distant metastasis.|Up to 10 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Percentage of participants||95% Confidence Interval|Number
1271713|NCT00346164|Secondary|Incidence of Distant Metastasis|Percent of patients who had distant metastasis.|Up to 10 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Percentage of participants||95% Confidence Interval|Number
1271714|NCT00346164|Secondary|Overall Survival Probability Extent of Resection of the Primary Tumor|Probability of survival after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Probability||95% Confidence Interval|Number
1271715|NCT00346164|Secondary|Overall Survival Probability Disease Extent|Probability of survival after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Probability||95% Confidence Interval|Number
1271716|NCT00346164|Secondary|Event Free Survival Probability Histologic Grade|Probability of no relapse, secondary malignancy or death after 5 years since enrollment|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Probability||95% Confidence Interval|Number
1271717|NCT00346164|Secondary|Event Free Survival Probability Disease Extent|Probability of no relapse, secondary malignancy or death after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Probability||95% Confidence Interval|Number
1271718|NCT00346164|Secondary|Percent Tumor Necrosis|Percent tumor necrosis by pathology review.|13 weeks|Only Arm D patients were evaluated at week 13 for percent tumor necrosis. Ineligible and inevaluable Arm D patients were excluded.|||percentage of tumor necrosis||Standard Deviation|Mean
1271719|NCT00346164|Secondary|Complete or Partial Response Rate|Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.|13 weeks|Only Arm D patients were evaluated for imaging response at week 13 after surgery. Ineligible and inevaluable Arm D patients were excluded.|||percentage of patients||95% Confidence Interval|Number
1271720|NCT00346164|Secondary|Toxicity Rate|Percentage of Arm D patients experiencing grade 4+ adverse events.|13 weeks|Excluding ineligible patients and patients not treated based on the protocol.|||percentage of participants||95% Confidence Interval|Number
1282013|NCT00249249|Secondary|Non-HDL:HDL Ratio|Ratio of non-HDL to HDL at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||||Standard Deviation|Mean
1271728|NCT00346151|Secondary|Proportion of Participants With Post-transplant Infections|Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)|Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
1271729|NCT00346151|Secondary|Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection|"Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
1271730|NCT00346151|Secondary|Time From Transplant to Acute Rejection|"Time (days) from transplant to occurrence of acute rejection[1]~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|Transplantation until rejection occurs (participants followed up to four years post-transplantation)|Intent to treat sample participants with rejection|||Days||Full Range|Median
1271731|NCT00346151|Secondary|Graft Survival at 12 Months Post-transplant||12 months post-transplant|Intent to treat sample participants not terminating prior to 12 months|||Participants|||Number
1271732|NCT00346151|Secondary|Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks|"GFR utilizing clearance of iothalamate.~GFR is an index of level of kidney function. A higher value means better kidney function."|24 weeks post-transplant|Intent to Treat Sample|||mL/min/1.73m^2||Standard Deviation|Mean
1271733|NCT00346151|Secondary|Tolerance Induction|Time from transplantation to initiation of sirolimus withdrawal.|48 months|Intent to treat sample that initiated sirolimus withdrawal|||Days|||Number
1271734|NCT00346151|Secondary|Acute Rejection at 12-Months|"Incidence of acute rejection[1] at 12 months post-transplant~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|12 months post-transplant|Intent to Treat Sample|||Participants|||Number
1271735|NCT00346151|Secondary|Participant Survival at 12 Months Post-Transplant||12 months post-transplant|Intent to Treat Sample participants not terminating prior to 12 months.|||Participants|||Number
1271736|NCT00346151|Primary|Acute Rejection at 6-Months|"Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|6 months post-transplant|Intent to Treat|||Participants|||Number
1271737|NCT00346073|Secondary|Number of Subjects Reporting the Onset of New Chronic Illnesses|New onset chronic illnesses include diabetes, asthma, allergies, autoimmune diseases.|During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.|||Participants|||Count of Participants
1271738|NCT00346073|Secondary|Number of Subjects Reporting Emergency Room Visits|Emergency room visits refer to AEs requiring immediate medical attention.|During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.|||Participants|||Count of Participants
1271739|NCT00346073|Secondary|Number of Subjects Reporting Hospitalizations|Hospitalization signified that the subject had been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out patient setting.|During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.|||Participants|||Count of Participants
1271740|NCT00346073|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed. Two subjects were not contacted after the active phase of study, but had SAEs reported in the ESFU period.|||Participants|||Count of Participants
1271741|NCT00346073|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the active phase of the study (Day 0 - Day 30)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1271814|NCT00345579|Primary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
1271742|NCT00346073|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day period (Days 0-30) following vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1271743|NCT00346073|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as temperature measured orally, greater than or equal to (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [gastro sympt.] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day period (Day 0-14) following vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
1271744|NCT00346073|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 15-day period (Day 0-14) following vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
1271745|NCT00346073|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1271746|NCT00346073|Secondary|Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)|Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 0.1 IU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥ 0.4 IU/mL), one month after vaccination; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination.|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1271747|NCT00346073|Secondary|Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies|A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to (≥) 1.0 international units per milliliter (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1271748|NCT00346073|Primary|Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration ≥ 5 EU/mL and < 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. The primary outcome results only refer to subjects who received a Boostrix vaccination.|||Participants|||Count of Participants
1271749|NCT00346073|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. The primary outcome results only refer to subjects who received a Boostrix vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1271750|NCT00346073|Primary|Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies|A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1271845|NCT00345033|Primary|Change in Total Cholesterol|A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N = 30).|||mg/dL||Standard Deviation|Mean
1271751|NCT00346073|Primary|Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1271752|NCT00346034|Primary|Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score|Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 “no pain” to 100 “worst possible pain”. Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.|Week 12 (end of treatment)|This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.|||mm||Standard Deviation|Mean
1271753|NCT00346034|Primary|Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score|Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 “no pain” to 100 “worst possible pain”. Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.|Week 4|This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4.|||mm||Standard Deviation|Mean
1271754|NCT00345969|Secondary|Change in Serum Testosterone Level|Total Serum Testosterone Level (ng/mL)|Baseline and Six Months|Only 9 participants in the Exercise+Testosterone group provided serum testosterone levels at baseline and 6-month follow-up.|||ng/mL||Standard Deviation|Mean
1271755|NCT00345969|Other Pre-specified|Change in Serum LDL Cholesterol Level||Baseline and Six Months|Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for LDL cholesterol measurements at baseline and 6 months.|||mg/dL||Standard Deviation|Mean
1271756|NCT00345969|Other Pre-specified|Change in Serum HDL Cholesterol Level||Baseline and Six Months|Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for HDL cholesterol measurements at baseline and 6 months.|||mg/dL||Standard Deviation|Mean
1271757|NCT00345969|Other Pre-specified|Change in Serum Total Cholesterol Level||Baseline and Six Months|Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for cholesterol measurements at baseline and 6 months.|||mg/dL||Standard Deviation|Mean
1271758|NCT00345969|Other Pre-specified|Change in Hematocrit|Percentage of the volume of whole blood composed of Red Blood Cells|Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided hematocrit measurements at baseline and 6-month follow-up.|||percent||Standard Deviation|Mean
1271759|NCT00345969|Other Pre-specified|Change in Serum Prostate Specific Antigen (PSA) Level||Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum PSA level measurements at baseline and 6 month follow-up.|||ng/mL||Standard Deviation|Mean
1271760|NCT00345969|Secondary|Change in Total Modified Physical Performance (mPPT) Score|The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living [ADL]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score.|Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided baseline and follow-up mPPT measurements.|||units on a scale||Standard Deviation|Mean
1271761|NCT00345969|Secondary|Change in Femoral Bone Mineral Density (BMD)|Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)|Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 10 participants in the Exercise+Testosterone group, provided femoral bone density measurements at baseline and the 6 month follow-up.|||g/cm2||Standard Deviation|Mean
1271762|NCT00345969|Secondary|Change in Total Body Fat Mass|Total Body Fat Mass as measured by DXA|Baseline and Six Months||||kg||Standard Deviation|Mean
1271763|NCT00345969|Secondary|Change in Leg Extension Torque at 60 Deg/Sec|Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec|Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 8 participants in the Exercise+Testosterone group, provided Leg extension torque measurements at baseline and 6 month follow-up.|||ft/lb||Standard Deviation|Mean
1271764|NCT00345969|Secondary|Change in Isokinetic Leg Extension Torque at 0 Deg/Sec|Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec|Baseline and Six Months|Only 10 participants in Exercise+Placebo group, and 8 participants in Exercise+Testosterone group, provided Leg Extension torque measurements at baseline and 6-month follow-up.|||ft/lb||Standard Deviation|Mean
1271765|NCT00345969|Primary|Change in Skeletal Muscle Strength by 1-RM|One-repetition maximum strength for leg extension|Baseline and Six Months|Only 8 participants in the Exercise+Testosterone group provided Leg Extension 1-RM measurements at baseline and 6-month follow-up.|||lbs.||Standard Deviation|Mean
1271766|NCT00345969|Primary|Mean Change in Total Lean Body Mass|Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)|Baseline and Six Months||||kg||Standard Deviation|Mean
1271767|NCT00345878|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
1271846|NCT00344968|Secondary|Retinal Thickness|Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.|36 months||||microns||Standard Deviation|Mean
1271768|NCT00345878|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)|"NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes, allergies,...~Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or SAEs that are not related to common diseases."|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
1271769|NCT00345878|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days after any vaccination||||Participants|||Count of Participants
1271770|NCT00345878|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.|During the 7 days after each vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1271771|NCT00345878|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 0 and Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1271772|NCT00345878|Primary|Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||Participants|||Count of Participants
1271773|NCT00345839|Secondary|Time to Parathyroidectomy|Time to Parathyroidectomy. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271774|NCT00345839|Secondary|Time to Bone Fracture|Time to Bone Fracture. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271775|NCT00345839|Secondary|Time to Stroke|Time to Stroke. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271776|NCT00345839|Secondary|Time to Cardiovascular Mortality|Time to Cardiovascular Mortality. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271777|NCT00345839|Secondary|Time to Peripheral Vascular Event|Time to Peripheral Vascular Event. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271778|NCT00345839|Secondary|Time to Heart Failure|Time to Heart Failure. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271779|NCT00345839|Secondary|Time to Hospitalization for Unstable Angina|Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271780|NCT00345839|Secondary|Time to Myocardial Infarction|Time to Myocardial Infarction. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271781|NCT00345839|Secondary|Time to All-cause Mortality|Time to All-cause Mortality. Stratified by history of diabetes and country.|From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271815|NCT00345579|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
1271782|NCT00345839|Primary|Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)|Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.|From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
1271783|NCT00345683|Primary|Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits||From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
1271784|NCT00345683|Primary|Number of Subjects With Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
1271785|NCT00345683|Primary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
1271786|NCT00345683|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
1271787|NCT00345683|Primary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits||From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
1271788|NCT00345683|Primary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
1271789|NCT00345683|Primary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
1271790|NCT00345683|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
1271791|NCT00345631|Secondary|Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events|Other known vascular closure related adverse events include: Rebleeding Following Initial Hemostasis; Access Site Hematoma >= 6cm; Access Site-Related Bleeding Requiring > 30 min for Hemostasis; Transient Access Site-Related Nerve Injury; Retroperitonea Bleeding; Decrease in Pedal Pulse|From end of vessel closure procedure to 30 days post-procedure|Intent to treat population|||Percentage of participants|||Number
1271792|NCT00345631|Secondary|Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure|Procedure success is defined as initial hemostasis achieved by the assigned method Vascular Closure Device (VCD) or Manual compression (MC) with none of the primary safety endpoint’s closure related major adverse events (MAE). Procedural success is assessed on day of catheterization procedure and at 30 days post-procedure.|From catheterization procedure to 30 day post-procedure follow up|Intent to Treat Population|||Percentage of participants|||Number
1271793|NCT00345631|Secondary|Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure|Device Success is defined as the successful deployment of the plug, initial hemostasis time less or equal to 5 minutes, and removal of the intact delivery system.|Within 5 minutes post-procedure|Intent to treat population (ITT) excluding the Manual Compression (MC) patients since MC Patients didn't deploy the device.|||Percentage of participants|||Number
1271794|NCT00345631|Secondary|Time to Device Deployment, up to 5 Minutes|Time to device deployment is defined as from the time device inserted to the time sheath removed|From device inserted to introducer sheath removal|Intent to Treat population with non-missing time data, excluding MC patients. Patients in the MC arm didn't deploy the device.|||Hour||Standard Deviation|Mean
1271795|NCT00345631|Secondary|Time to Hospital Discharge|Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge|From introducer sheath removal to patient discharge|Intent to Treat population with non-missing time data|||Hour||Standard Deviation|Mean
1271796|NCT00345631|Secondary|Time to Eligibility for Hospital Discharge|Time to Eligibility for Hospital Discharge is measured from the time of sheath removal to the time when the patient is eligible for discharge according to the judgment of the patient’s physician.|From introducer sheath removal to hospital discharge, up to 284 hours|Intent to treat population with non-missing time data|||Hour||Standard Deviation|Mean
1271816|NCT00345540|Secondary|Progression Free Survival (PFS)||From time of treatment start to time of disease progression||||Weeks||Full Range|Mean
1271817|NCT00345540|Secondary|Safety of NOV-002 and Carboplatin||Duration of trial and through 30-day follow-up period after final treatment||||Adverse Events|||Number
1271818|NCT00345540|Primary|Response Rate||At treatment completion (8 weeks) and monthly until disease progression||||Participants|||Number
1271797|NCT00345631|Primary|Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure|Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (> 30 days) access site-related nerve injury.|From post-procedure to 30 days follow up|Intent to treat population|||Percentage of participants|||Number
1271798|NCT00345631|Primary|Time to Ambulation (TTA)|Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.|From when the introducer sheath was removed to 30 days post-procedure|Intent to Treat (ITT)Population with non-missing time to ambulation data.|||Hours||Standard Deviation|Mean
1271799|NCT00345631|Primary|Time to Hemostasis (TTH)|Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.|From when the introducer sheath was removed to the time hemostasis was first observed|Intent to treat population (ITT) with non-missing time to hemostasis data. ITT population consists of all randomized (VCD and MC) patients where a femoral artery closure procedure is attempted post-randomization.|||Minutes||Standard Deviation|Mean
1271800|NCT00345605|Primary|Measures of Liver Function: INR|The result (in seconds) for a prothrombin time performed on a normal individual will vary according to the type of analytical system employed. This is due to the variations between different batches of manufacturer's tissue factor used in the reagent to perform the test. The INR was devised to standardize the results. Each manufacturer assigns an ISI value (International Sensitivity Index) for any tissue factor they manufacture. The ISI value indicates how a particular batch of tissue factor compares to an international reference tissue factor. The ISI is usually between 1.0 and 2.0. The INR is the ratio of a patient's prothrombin time to a normal (control) sample, raised to the power of the ISI value for the analytical system being used.|Measured after each 1-week treatment period||||seconds||Inter-Quartile Range|Mean
1271801|NCT00345605|Primary|Measures of Liver Function: Coagulation Factors|Plasma levels of coagulation factors I and IX were used as measures of hepatic synthetic function since the treatment duration was short.|Measured after each 1-week treatment period||||mg/dL||Standard Deviation|Mean
1271802|NCT00345605|Primary|Measures of Liver Function: PT and PTT|Prothrombin time (PT) and partial thromboplastin time (PTT) were measured PT measures factors I (fibrinogen), II (prothrombin), V, VII, and X, while PTT is a performance indicator of the efficacy of the common coagulation pathways.|Measured after each 1-week treatment period||||seconds||Inter-Quartile Range|Mean
1271803|NCT00345605|Secondary|Urea Production Rate||Measured after each 1-week treatment period||||micromoles/kg/hr||Standard Deviation|Mean
1271804|NCT00345605|Secondary|Arginine Levels||Measured after each 1-week treatment period||||micromoles/L||Inter-Quartile Range|Median
1271805|NCT00345605|Secondary|Argininosuccinic Acid Levels||Measured after each 1-week treatment period||||micromole/l||Inter-Quartile Range|Median
1271806|NCT00345605|Primary|Measures of Liver Function: AST and ALT|Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were measured.|Measured after each 1-week treatment period||||IU/L||Standard Error|Mean
1271807|NCT00345592|Primary|Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation||3 years from randomization (39 months total)||||participants|||Number
1271808|NCT00345579|Primary|Number of Subjects With Adverse Events Resulting in Emergency Room (ER)||From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
1271809|NCT00345579|Primary|Number of Subjects With Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
1271810|NCT00345579|Primary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
1271811|NCT00345579|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
1271812|NCT00345579|Primary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)||From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
1271813|NCT00345579|Primary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
1271843|NCT00345033|Primary|Change in Body Mass Index (BMI)|A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).|||kg/m^2||Standard Deviation|Mean
1271819|NCT00345397|Primary|Change in Bowel QoL|"Spinal Cord Injury (SCI) -Specific, 20-Question QoL Instrument used a Visual Analog Scale (VAS) for each item.~These were scored by measurement and recording 1-10 along the scale (1 being best, 10 being worst) An average of the scores for the 20-items was calculated for each subject before and after Percutaneous Endoscopic Colostomy (PEC) Tube placement.~A Global SCI-QoL Score was also recorded using the same VAS. The difference between these Intake and Exit scores was used to define change in SCI-Specific Quality of Life."|Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement|Subjects completing both Intake and Exit assessments|||units on a scale||Standard Deviation|Mean
1271820|NCT00345384|Secondary|Measure the Amount of Respiratory Depression in Each Groups|Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours.|Hours 6 to 16||||mmHg||Standard Deviation|Mean
1271821|NCT00345384|Primary|Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm.|To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.|An average of 24 hours, up to 30 hours per patient|Participants completing the study were analyzed as per protocol|||IV morphine equivalency in mg||95% Confidence Interval|Number
1271822|NCT00345371|Secondary|Abstinence (Weeks 1 - 12)|Number of participants who abstained from methamphetamine from weeks 1 through 12|Weeks 1 through 12||||Participants|||Count of Participants
1271823|NCT00345371|Primary|Abstinence (Weeks 6 - 12)|The number of participants who abstained from methamphetamine from weeks 6 through 12|weeks 6 through 12||||Participants|||Count of Participants
1271824|NCT00345332|Secondary|Number of Incontinence Pads Used Per Day|The number of incontinence pads used per day per day was recorded by each participant in a diary.|week 13||||pads per day||Standard Error|Geometric Least Squares Mean
1271825|NCT00345332|Primary|Incontinent Episodes Per Day|The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.|week 13||||incontinence episodes per day||Standard Error|Geometric Least Squares Mean
1271826|NCT00345293|Secondary|Clinical Response||Post treatment|This data was not collected due to differences in immunogenicity based on different dendritic cell preparations. This data was no longer relevant.||||||
1271827|NCT00345293|Secondary|Immunogenicity|The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).|pre and post treatment|One other participant in DC/PC3 vaccine-Selected group not analyzed due to failed controls in assay.|||counts per minute||Full Range|Median
1271828|NCT00345293|Primary|Toxicity|adverse events|through week 29||||events|||Number
1271829|NCT00345254|Primary|Umbilical Cord pH||immediately after delivery||||pH||Standard Deviation|Mean
1271830|NCT00345176|Other Pre-specified|Genetics for the Progression of AMD and Cataract||5 years of follow-up|||||||
1271831|NCT00345176|Other Pre-specified|Genetics for the Association of AMD and Cataract||5 years of follow-up|||||||
1271832|NCT00345176|Other Pre-specified|Prevalence of Peripheral Changes as Measured Using OPTOS Imaging|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on the peripheral retina|5 years of follow-up|||||||
1271833|NCT00345176|Other Pre-specified|Cognition as Measured by a Telephone Battery|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin, zinc, and beta-carotene on cognitive function|5 years of follow-up|||||||
1271834|NCT00345176|Other Pre-specified|Incident Cardiovascular Disease|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on cardiovascular disease|5 years of follow-up|||||||
1271835|NCT00345176|Secondary|Progression to Cataract Surgery|The study examined the effects of lutein/zeaxanthin on progression to cataract surgery with data collected during regular telephone contacts and the annual study visits.|5 years of follow-up|Includes participants who were phakic in at least 1 eye at baseline|||Eyes|Participants||Number
1271836|NCT00345176|Secondary|Adverse Events|Safety outcomes included serious adverse events and mortality.|5 years of follow-up|Number of deaths in 5 years|||Participants|||Number
1271837|NCT00345176|Secondary|Progression to Moderate Vision Loss|Loss defined as >/= 3 lines of letters from baseline or treatment for choroidal neovascularization|5 years of follow-up||||Eyes|Participants||Number
1271838|NCT00345176|Primary|Development of Advanced AMD in People at Moderate to High Risk for Progression.|Defined as central geographic atrophy or retinal features of choroidal neovascularization detected on central grading of the stereoscopic fundus photographs or a history of treatment for advanced AMD after study enrollment.|5 years of follow-up|Intention to Treat. Participants lost to follow-up during the course of the study were censored at the time of last contact.|||Eyes|Participants||Number
1271839|NCT00345046|Primary|Percent Change in Flare at Resolution||2 months||||Percent change in flare||Standard Deviation|Mean
1271840|NCT00345033|Primary|Change in Insulin Resistance|A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30)|||HOMA score||Standard Deviation|Mean
1271841|NCT00345033|Primary|Change in Triglycerides||Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30)|||mg/dL||Standard Deviation|Mean
1271842|NCT00345033|Primary|Change in Glucose Metabolism|A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).|||min^-1||Standard Deviation|Mean
1271844|NCT00345033|Primary|Change in Weight|A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).|||kg||Standard Deviation|Mean
1271847|NCT00344968|Primary|Visual Acuity|The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).|36 months|Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.|||percentage of subjects|||Number
1271848|NCT00344773|Secondary|Safety Profile: Participants With Adverse Events|Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.|baseline to end of study|||||||
1271849|NCT00344773|Secondary|Overall Survival (OS)|Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.|baseline to 12 months||||Percent of Participants|||Number
1271850|NCT00344773|Secondary|Progression Free Survival (PFS)|Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.|baseline to 4 months||||Percent of Participants|||Number
1271851|NCT00344773|Primary|Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.|"Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.~RECIST criteria:~CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria"|baseline to 12 months||||Percent of Participants|||Number
1271852|NCT00344682|Secondary|Montgomery-Asberg Depression Rating Score (MADRS)|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6 on 10 items. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in response rate and remission rate were assessed for secondary measures.|baseline and week 8|Secondary outcome examines a change in response rates,when 50% change from baseline, & remission rates, when MADRS scores of 12 or less were observed.Fischer exact tests assessed efficiency in each treatment group. Intent-to-treat rates at baseline minus week 8 through last observed data carried forward (LOCF) were used;no data values were imputed|||units on a scale||Standard Deviation|Mean
1271853|NCT00344682|Secondary|Hamilton Anxiety Rating Scale (HARS)|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Scores > 30 indicate severe anxiety.|baseline & week 8|Secondary outcome examines a change in mean HARS scores observed at baseline & week 8 through last observed data carried forward (LOCF);no values were imputed for missing assessments.Efficacy data analysis used intent-to-treat measures & computes final study score minus baseline averaged among participants to evaluate treatment group differences|||units on a scale||Standard Deviation|Mean
1271854|NCT00344682|Secondary|Modified Quick Inventory of Depressive Symptoms Self Report Scale (QIDS-SR)|The 16 item Quick Inventory of Depressive Symptomatology (QIDS-SR16) (Rush et al. 2003) is designed to assess the severity of depressive symptoms, with higher scores representing more severe forms of depression. When complete, the QIDS are scored by summing responses to obtain a total score ranging from 0 to 27. Either appetite increase or decrease, but not both, are used to calculate the total score. Weight increase or decrease, but not both, are used to calculate the total score. Scores 0-5 indicate no severity of depression; 6-10 is mild; 11-15 is moderate; 16-20 is severe; 21-27 is very severe levels of depression. Participants were evaluated at baseline and at weeks 1, 2, 3, 4, 6 & 8.|baseline & week 8|The secondary outcome examines a change over in mean QID-SR scores at baseline & week 8 through last observed data carried forward (LOCF); no values were imputed for missing assessments. Data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.|||units on a scale||Standard Deviation|Mean
1271855|NCT00344682|Primary|Montgomery-Asberg Depression Rating Score (MADRS)|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in MADRS score was a primary measure.|Baseline & week 8|The primary outcome examines a mean change in MADRS scores at baseline & week 8 through last observation carried forward (LOCF); no values were imputed for missing assessments. The primary data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.|||units on a scale||Standard Deviation|Mean
1271856|NCT00344500|Primary|Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis|Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.|12 months||||Body Fat Percentage Change|||Number
1271874|NCT00344318|Secondary|Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity)|Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271857|NCT00344500|Primary|Change in Predicted Trajectory of Mean BMI Per GLMM Analysis|General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.|12 months||||kg/m^2|||Number
1271858|NCT00344500|Primary|Mean Weight|Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.|Weekly/Monthly, up to 1 year|All subjects who enrolled in this research program. Subjects were assessed weekly, when able. Since some were not able to do every weekly assessment, N varies weekly, and the weekly assessments below are the means of the number of subjects out of the total in the group who were assessed at that point.|||Pounds||Standard Deviation|Mean
1271859|NCT00344487|Primary|Baseline Will be Defined as the Mean of 2 Values Obtained Prior to the Medication Switch (for Analysis Purposes, the CD4 Cell Counts at 6 and 12 Months Will be Defined by the Mean of the CD4 Cell Counts Obtained at Months 3, 6 or 9, 12, Respectively).||3, 6, 0r 9, 12 months respectively|||||||
1271860|NCT00344487|Primary|Changes From Baseline in CD4 Cell Count at 6 and 12 Months||6 and 12 months|||||||
1271861|NCT00344487|Primary|Changes From Baseline in CD4 Cell Percentage at 6 and 12 Months||Baseline, 6 and 12 months||||Percentage of CD4 Cells||Standard Deviation|Mean
1271862|NCT00344487|Primary|Absolute Change in CD4 Cell Count From Baseline, and at 6 and 12 Months||6 and 12 months|||||||
1271863|NCT00344461|Secondary|Changes in CD4 Cell Count From Baseline and Week 96|To determine the mean change from Baseline in CD4 cell count to week 96.|Baseline to week 96||||percentage of CD4 Increase||Standard Deviation|Mean
1271864|NCT00344461|Secondary|Change in Plasma HIV RNA From Baseline to Week 96|Percent Change From Baseline in Plasma HIV RNA at 96 weeks|Baseline to week 96||||percentage of change||Standard Deviation|Mean
1271865|NCT00344461|Secondary|Patients With Plasma HIV RNA < 400 Copies/mL|The number of participants with plasma HIV RNA < 400 copies/mL|96 weeks||||Participants|||Count of Participants
1271866|NCT00344461|Secondary|Patients With Plasma HIV RNA < 50 Copies/mL|The number of participants with plasma HIV RNA < 50 copies/mL|96 weeks.||||Participants|||Count of Participants
1271867|NCT00344461|Secondary|Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities|The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities.|Protocol length is 96 weeks||||Participants|||Count of Participants
1271868|NCT00344461|Primary|Number of Participants With Sustained Virologic Response|The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks.|96 Weeks|HIV-1 infected Males: cluster of differentiation 4 (CD4) cell count less than 400 cells/mm3 and viral load greater than 5,000c/ml) Females: CD4 cell count less than 250 cells/mm3 and viral load greater than 5,000 c/mL at time of enrollment. Treatment naive|||Participants|||Count of Participants
1271869|NCT00344448|Primary|Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks|"Patient will be considered a responder if (s)he demonstrates improvement in 2 / 3 disease activity measures without worsening of the third one.~Salivary flow: 0.45 ml / 15 min improvement in unstimulated whole salivary flow from baseline value obtained at the study entry.~Salivary gland biopsy:~at least 2 points improvement in the focus score on MSG biopsy~Tear flow:~at least 30% improvement in ophthalmic Oxford grading scheme or normalization of the scale as defined by score of 0 or 2mm improvement in Schirmer test as compared with the baseline in either eye."|3 months||||participant|||Number
1271870|NCT00344370|Secondary|Percent Change From Baseline in LDL-C|Percent change from baseline in LDL-C at 44 weeks|Basseline to 44 weeks||||percent change||Standard Deviation|Mean
1271871|NCT00344370|Primary|NCEP LDL-C Target Attainment|Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.|44 weeks|The efficacy population is defined as all patients who received at least one dose of study drug and who had at least one on-treatment lipid assessment|||Participants|||Number
1271872|NCT00344318|Secondary|Number of Subjects With Vaccine Response to Bordetella Pertussis|Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations < 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL).|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271873|NCT00344318|Secondary|Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations|Seropositivity status, defined as Anti-BPT antibody concentrations ≥ 15 EL.U/mL.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1271895|NCT00344318|Secondary|Number of Subjects With Serious Adverse (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1271875|NCT00344318|Secondary|Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers|Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1271876|NCT00344318|Secondary|Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8|Titers were expressed as geometric mean titres (GMTs).|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271877|NCT00344318|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1271878|NCT00344318|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL)|Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271879|NCT00344318|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1271880|NCT00344318|Secondary|Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL)|Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271881|NCT00344318|Secondary|Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations|Seroprotection status, defined as Anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1271882|NCT00344318|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)|Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271883|NCT00344318|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL)|Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271884|NCT00344318|Secondary|Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL)|Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271928|NCT00344019|Secondary|Inflammatory Markers (CRP)|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours|||||||
1271929|NCT00344019|Secondary|Other Biomarkers of Myocyte Injury (CK, CK-MB)|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours|||||||
1271885|NCT00344318|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL)|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1271886|NCT00344318|Secondary|Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271887|NCT00344318|Secondary|Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1271888|NCT00344318|Secondary|Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL)|Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271889|NCT00344318|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1271890|NCT00344318|Secondary|Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F ≥ 8.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271891|NCT00344318|Secondary|Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1271892|NCT00344318|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL)|Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271893|NCT00344318|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL)|Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1271894|NCT00344318|Secondary|Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1275126|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|4 Weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
1271896|NCT00344318|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1271897|NCT00344318|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within 31 days (Days 0-30) after each vaccination|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1271898|NCT00344318|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.|Within 4-day (Days 0-3) after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Participants|||Count of Participants
1271899|NCT00344318|Secondary|Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|Within 4 day (Days 0-3) after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Participants|||Count of Participants
1271900|NCT00344318|Primary|Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)|Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.|Within 4 day (Days 0-3) after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. For reasons of safety analysis related to rectal temperature, subjects were pooled to form the Synflorix Pooled Group and Prevenar Group.|||Participants|||Count of Participants
1271901|NCT00344305|Secondary|Number of Participants With REs in Relation to Any Vaccine Virus Shedding|REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability.|Days 0-28 after study vaccination (up to Day 28)|Safety population included all participants who received any study drug and had experienced any follow-up for safety. Here, number of participants analyzed signified those participants who had REs.|||participants|||Number
1271902|NCT00344305|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An SNMC is defined as a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. SNMCs included, but were not limited to, diabetes, asthma, autoimmune disease (lupus, rheumatoid arthritis), and neurological disease (epilepsy, autism).|Days 0-180 after vaccination (up to 6.5 months)|Safety population included all participants who received any study drug and had experienced any follow-up for safety.|||participants|||Number
1271903|NCT00344305|Secondary|Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination|REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Days 0-28 after vaccination (up to Day 28)|Safety population included all participants who received any study drug and had experienced any follow-up for safety.|||participants|||Number
1271904|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 37°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.|||participants|||Number
1271930|NCT00344019|Primary|Peri-procedural Myonecrosis|As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT|24 hours|Study closed due to slow recruitment and data was not analyzed. Collected data is no longer available as retention period has passed and investigator has left the institution.||||||
1271905|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 39°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.|||participants|||Number
1271906|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the cold-adapted (ca) and temperature-sensitive (ts) phenotypes. Viruses were considered ts if their titer at 39 degrees Celsius (°C) was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.|||participants|||Number
1271907|NCT00344305|Secondary|Quantitation of Confirmed B Shed Vaccine Virus on Any Day|Quantitation of confirmed B shed vaccine virus was evaluated using the log (TCID50)/mL for B vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||log (TCID50)/mL||Standard Deviation|Mean
1271908|NCT00344305|Secondary|Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day|Quantitation of confirmed A/H3N2 shed vaccine virus was evaluated using the log (TCID50)/mL for A/H3N2 vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||log (TCID50)/mL||Standard Deviation|Mean
1271909|NCT00344305|Secondary|Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day|Quantitation of confirmed A/H1N1 shed vaccine virus was evaluated using the log transformed median tissue culture infectious dose (TCID50) per (/) millilitre (mL) for A/H1N1 vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||log (TCID50)/mL||Standard Deviation|Mean
1271910|NCT00344305|Secondary|Duration of Confirmed B Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed B strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||days||Standard Deviation|Mean
1271911|NCT00344305|Secondary|Duration of Confirmed A/H3N2 Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||days||Standard Deviation|Mean
1271912|NCT00344305|Secondary|Duration of Confirmed A/H1N1 Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||days||Standard Deviation|Mean
1271913|NCT00344305|Secondary|Duration of Any Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed any vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||days||Standard Deviation|Mean
1271914|NCT00344305|Primary|Percentage of Participants Who Shed B Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1272007|NCT00343083|Secondary|Pathological Response to Cetuximab|Adding CTX to weekly PC and daily RT. CBC and Chemistry panel blood testing|2 years||||participants|||Number
1271915|NCT00344305|Primary|Percentage of Participants Who Shed A/H3N2 Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1271916|NCT00344305|Primary|Percentage of Participants Who Shed A/H1N1 Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1271917|NCT00344305|Primary|Percentage of Participants Who Shed Any Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1271918|NCT00344175|Secondary|Percent Change From Baseline in LDL-C||Baseline to 44 weeks||||percent change||Standard Deviation|Mean
1271919|NCT00344175|Primary|Number of Patients Attaining NCEP LDL-C Target at Week 44|Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.|44 Weeks||||Participants|||Number
1271920|NCT00344175|Primary|Number of Patients Attaining NCEP LDL-C Target at Week 16|Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.|16 weeks|All patients who received at least 1 dose of study drug and who had at least 1 on-treatment (post Visit 1) lipid assessment.|||particpants|||Number
1271921|NCT00344032|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
1271922|NCT00344032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
1271923|NCT00344032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days (Days 0 - 29) after each vaccination||||Participants|||Count of Participants
1271924|NCT00344032|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.|During the 7 days (Days 0 - 6) after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1271925|NCT00344032|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Months 0 and 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1271926|NCT00344032|Primary|Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||Participants|||Count of Participants
1271927|NCT00344019|Secondary|Post PCI Growth of Tissue Level Perfusion Circumference and Brightness Using Digital Subtraction Angiography|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours|||||||
1271931|NCT00343915|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|At Month 30, Month 42, Month 54 & Month 66|LT total cohort included all subjects who were included in the total cohort in the primary study and returned at the considered follow-up time point.|||Participants|||Number
1271932|NCT00343915|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Month 0 to Month 66)|Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group.|||Subjects|||Number
1271933|NCT00343915|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-30) follow-up period after each vaccination and overall|Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group|||Subjects|||Number
1271934|NCT00343915|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccination and overall|The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.|||Subjects|||Number
1271935|NCT00343915|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccination and overall|The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.|||Subjects|||Number
1271936|NCT00343915|Secondary|Number of Subjects Seroprotected for Anti-HBs Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Months 1, 2 and 6|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||Subjects|||Number
1271937|NCT00343915|Secondary|Antibody Titers Against Hepatitis-B Virus.|Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.|At Months 1, 2, 6 and 7|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||mIU/mL||95% Confidence Interval|Geometric Mean
1271938|NCT00343915|Primary|Antibody Titers Against Hepatitis-B Virus.|Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.|At Month 30, Month 42, Month 54 and Month 66|Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
1271939|NCT00343915|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 30, Month 42, Month 54 and Month 66|Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.|||Subjects|||Number
1271940|NCT00343915|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 7|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||Subjects|||Number
1271941|NCT00343889|Secondary|Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 after each vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.|||Participants|||Number
1271942|NCT00343889|Secondary|Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA).~Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination."|1 month post third vaccination|Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibodies were assessed in the per-protocol population.|||Participants|||Number
1271943|NCT00343889|Secondary|Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies.~Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination."|1 month post third vaccination|Anti-Hepatitis B Responses was assessed in the per-protocol population.|||Participants|||Number
1271944|NCT00343889|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).|1 month post third vaccination|Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1271945|NCT00343889|Primary|Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.~Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination."|1 month post third vaccination|Seroprotection to hepatitis H Antigen was assessed in the per-protocol population.|||Participants|||Number
1271946|NCT00343889|Secondary|Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.~Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination."|1 month post third vaccination|Anti-Hepatitis B Responses was assessed in the per-protocol population.|||Participants|||Number
1271947|NCT00343863|Secondary|Quality of Life||Up to 3 months||||FLIE questionnaires|FLIE questionnaires||Count of Units
1271948|NCT00343863|Secondary|Severity of Nausea|Count of participants with severe nausea|Up to 3 months||||Participants|||Count of Participants
1271949|NCT00343863|Secondary|Side Effects of Antiemetic Medications Used||Up to 3 months||||Participants|||Count of Participants
1271950|NCT00343863|Secondary|Number of Doses of Rescue Medications Used||Days 1-7 of each cycle|Patients were unable to consistently complete this part of the FLIE questionnaire and thus we did not retain data from any of the participants.||||||
1271951|NCT00343863|Secondary|Number of Participants That Had First Administration of Rescue Medication Within 48 Hours|Count of patients that had first administration of rescue medication within 48 Hours|up to 48 hours of chemotherapy||||Participants|||Count of Participants
1271952|NCT00343863|Secondary|Number of Participants That Had Emesis Within 48 Hours of Chemotherapy|Count of patients that had emesis within 48 hours of chemotherapy|Up to 48 hours of chemotherapy||||Participants|||Count of Participants
1271953|NCT00343863|Secondary|Number of Days With Emetic Episodes and Rescue Medicines||Up to 3 months||||days||Full Range|Median
1271954|NCT00343863|Secondary|Count of Patients Achieving Complete Response||At 24-120 hours after weekly intravenous doxorubicin||||Participants|||Count of Participants
1271955|NCT00343863|Primary|Count of Patients Achieving a Complete Response||At 0-24 hours after weekly intravenous doxorubin||||Participants|||Count of Participants
1271956|NCT00343785|Secondary|Overall Survival|Number of patients alive at one year|From the time of enrollment until death from any cause up to one year|All Patients|||Participants|||Count of Participants
1271957|NCT00343785|Secondary|Number of Days to Neutrophil Recovery to >500/uL|First of 3 consecutive days of neutrophils >500/uL|100 days post-transplant|All patients|||days||Full Range|Median
1271958|NCT00343785|Primary|Incidence of Chronic GVHD|Analyzed using cumulative incidence estimates, treating death or rejection as competing risk events.|2 years|All Patients|||number participants with chronic GVHD|||Number
1271959|NCT00343564|Secondary|Phase 1: Pharmacokinetics of SB-743921 Administered on a Days 1 and 15 of a 28 Day Cycle.||28 days|||||||
1271960|NCT00343564|Primary|Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.|Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).|28 days|Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations.|||mg/m2|||Number
1271961|NCT00343512|Secondary|Tumor Response as Measured by Ultrasound|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|At screening, 8 weeks and at surgery (within 14-21 days)||||participants|||Number
1271962|NCT00343512|Secondary|Safety Profile Based on Number of Patients With Each Worst-grade Toxicity|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria|Through 30 days after completion of treatment||||participants|||Number
1271963|NCT00343512|Primary|Number Participants to Achieve Pathologic Complete Response|whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)|3 month||||participants|||Number
1271964|NCT00343460|Secondary|Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1|Subject who were very satisfied on Day 1|0- 24 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
1271965|NCT00343460|Secondary|Quality of Life and the Impact of Nausea and Vomiting on Day 5|Functional Living Index|5 days|Cycle 1 - Modified Intent-to-Treat Population (All Languages Except Punjabi)|||participants|||Number
1271966|NCT00343460|Secondary|Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses|"Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles~Complete Response is defined as no emetic episodes and no use of rescue medications"|0-120 Hours|Number of subjects in the Modified Intent-to-Treat Population with overall CR (0-120 hrs) in all cycles|||participants with overall CR|||Number
1271967|NCT00343460|Secondary|Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)|Maximum severity of nausea, days 1-5|0-120 Hours|Severity of Nausea - Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
1271968|NCT00343460|Secondary|First and Overall Use of Rescue Medication||0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
1271969|NCT00343460|Secondary|Time to First Treatment Failure|Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration|0-120 Hours|Proportions of subjects event free in Cycle 1 - Modified Intent-to-Treat Population|||Proportion of subjects event free|||Number
1271970|NCT00343460|Secondary|Number of Emetic Episodes|Number of Emetic Episodes - days 1-5|Days 1-5|Cycle 1 - Modified Intent-to-Treat Population|||Number of Emetic Episodes||Standard Deviation|Mean
1271971|NCT00343460|Secondary|Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1|"TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1.~TR during delayed-onset phase is defined as Complete Response with no nausea during >24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1."|0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
1271972|NCT00343460|Secondary|Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1|Complete control is defined as complete response with no more than mild nausea.|0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
1271973|NCT00343460|Primary|Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1|Complete Response is defined as no emetic episodes and no use of rescue medications|24-120 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
1271974|NCT00343460|Primary|Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1|Complete Response is defined as no emetic episodes and no use of rescue medications|0-24 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
1271975|NCT00343382|Secondary|Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores|The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.|Baseline and Week 6|Includes all participants who completed both baseline and week 6 assessments.|||units on a scale||Standard Deviation|Mean
1271976|NCT00343382|Secondary|Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living|The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.|Baseline to Week 6|Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).|||units on a scale||Standard Deviation|Mean
1271977|NCT00343382|Secondary|Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0|CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|End of 6 weeks||||participants|||Number
1271978|NCT00343382|Primary|Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics|Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.|Baseline to Week 6|Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).|||units on a scale||Standard Deviation|Mean
1271979|NCT00343291|Secondary|Percentage of Participants With Symptomatic Response (Symptom Response Rate)|Functional Assessment of Cancer Therapy for Patients With Lung Cancer (FACT-L) measures domains of health-related quality of life (HR-QL): physical wellbeing (WB), social/family WB, emotional WB, functional WB, and additional lung cancer concerns. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item Lung cancer subscale (LCS) score maintained for 2 consecutive assessments. Scores range from 0-28 with higher scores indicating fewer symptoms. Patients with a score of >26 were not evaluable for symptom response, since a score of 28 is the maximum possible.|From date of partial response until progression of disease up to 31.8 months|Included all enrolled, randomized participants with a score of ≤26 at baseline. All participants were analyzed as part of the treatment group to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1272008|NCT00343083|Secondary|Overall Survival and Disease-free Survival||3 years (overall) 2 years disease-free||||percentage of participants|||Number
1272009|NCT00343083|Secondary|Local Regional Control at 2 Years||2 years||||percentage of participants|||Number
1272010|NCT00343083|Primary|The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy.|The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.|3 months||||participants|||Number
1271980|NCT00343291|Secondary|Duration of Overall Response|The duration of response, in participants with best overall response of CR or PR, is measured from the date criteria are met for CR/PR (whichever is first recorded), until the first date that the criteria for PD is met or death. CR, PR, and PD, as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions; PD≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.|Time of first response to the first date of PD or death due to any cause up to 31.8 months|Included all enrolled, randomized participants with a best overall response of CR or PR (responders). All participants were analyzed as part of the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
1271981|NCT00343291|Secondary|Percentage of Participants Achieving an Objective Overall Response (Overall Response Rate)|The best objective overall response rate (ORR) is the percentage of randomized participants with a best overall response of complete response (CR) or partial response (PR), as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions. ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated in that arm, multiplied by 100. Participants with no post-baseline evaluation will be considered as a non-responder.|Randomization to measured progressive disease up to 31.8 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1271982|NCT00343291|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death. Participants who are alive will be censored on the last known alive date.|Randomization to the date of death from any cause up to 42.7 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
1271983|NCT00343291|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD ≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.|Randomization to PD or date of death from any cause up to 33.1 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
1271984|NCT00343252|Secondary|Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 18 Months|Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.|||units on a scale||Standard Error|Least Squares Mean
1271985|NCT00343252|Secondary|Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.|Baseline, 18 Months|Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.|||units on a scale||Standard Error|Least Squares Mean
1271986|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months|Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Baseline through 18 Months|Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.|||participants|||Number
1271987|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Baseline through 18 Months|Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.|||participants|||Number
1271988|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.|18 Months|Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug.|||participants|||Number
1272011|NCT00343044|Secondary|Number or Participants With Toxicity||measured at each treatment cycle||||participants|||Number
1272012|NCT00343044|Secondary|Objective Response Rate|RECIST criteria|Response||||participants|||Number
1271989|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.|18 Months|Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug.|||participants|||Number
1271990|NCT00343252|Secondary|Number of Participants With Adverse Events (Safety) During 18 Months|Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.|Baseline through 18 Months|Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.|||participants|||Number
1271991|NCT00343252|Secondary|Number of Participants With Adverse Events (Safety) During 12 Months|Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.|Baseline through 12 Months|Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.|||participants|||Number
1271992|NCT00343252|Secondary|Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1271993|NCT00343252|Secondary|Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1271994|NCT00343252|Secondary|Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1271995|NCT00343252|Secondary|Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1271996|NCT00343252|Secondary|Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 3 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1271997|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months|Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.|||participants|||Number
1272013|NCT00343044|Secondary|Evaluation of Overall Survival|Overall survival was defined as the number of months after commencing study treatment to death.|PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.|The planned enrollment of 40 participants was determined using a median PFS of 9 months (based on a median PFS of 7.2 months in a previous trial).|||months||95% Confidence Interval|Median
1271998|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months|Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days.|||participants|||Number
1271999|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.|||participants|||Number
1272000|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.|||participants|||Number
1272001|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.|12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||participants|||Number
1272002|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.|6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||participants|||Number
1272003|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.|12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||participants|||Number
1272004|NCT00343252|Primary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.|6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||participants|||Number
1272005|NCT00343083|Secondary|Clinical Complete Response Rate of This Regimen in the Population|What is the the complete response (CR) rate at the completion of therapy.|3 months||||percentage of participants|||Number
1272006|NCT00343083|Secondary|Percentage of Participants With Grade 3 Toxicities of Cetuximab|"One of the more serious side effects of cetuximab therapy is the incidence of acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible.~Further severe infusion reactions include but are not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity."|9 weeks||||percentage of participants|||Number
1272014|NCT00343044|Primary|Progression Free Survival|Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.|PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.|This was determined assuming a median progression free survival of 9 months and an analysis calculating the sample size at which the narrowing of its 95% confidence interval became greater than .20 for every 2 patients added. Progression free survival and overall survival were estimated by using the Kaplan Meier method.|||months||95% Confidence Interval|Median
1272015|NCT00342628|Secondary|Antibody Responses to Hib CP|IgG anti-Hib CP was measured by ELISA in sera of 30 randomly chosen infants per group|Cord sera and infant sera at 7, 12, and 13 months|Randomly chosen 30 participants in each group. Four in Comparison group 2 were excluded from analyses due to classification error.|||mcg/ml||Inter-Quartile Range|Geometric Mean
1272016|NCT00342628|Secondary|Antibody Responses to Tetanus Toxoid, Diphtheria Toxoid, and Pertussis Toxin|IgG anti-diphtheria toxoid (DT), -tetanus toxoid (TT) and -pertussis toxin (PT) were measured by ELISA in sera of 30 randomly chosen infants per group.|Cord sera, and infants' sera at 7, 12 and 13 months of age|Randomly chosen 30 participants in each group. Four in Comparison group 2 were excluded from analyses due to classification error.|||U/ml||Inter-Quartile Range|Geometric Mean
1272017|NCT00342628|Secondary|IgG Anti-Vi Levels|IgG anti-Vi was measured by ELISA and expressed as ELISA units (EU)in all sera.|cord sera, infants' sera at 7, 12 and 13 months|Only participants with available cord sera are included in the analyses|||ELISA units||Inter-Quartile Range|Geometric Mean
1272018|NCT00342628|Primary|Number of Infants With Adverse Reactions After Vaccination|Number of infants with Fever>=38.0 C, Induration>=2.5cm at DTP site, Induration>=2.5cm,Vi-rEPA/Hib-TT site, Erythema>=2.5cm, at DTP site, Erythema>=2.5cm, Vi-rEPA/Hib-TT site, Inconsolable crying<4hr, Inconsolable crying>=4hr per injection with Vi conjugate vaccine given in conjunction with DTP in infants.|at 2, 4, 6 and 12 months|The number of infants injected in each group for each injection was used to determine the rate of adverse reactions.|||participants|||Number
1272019|NCT00342563|Primary|Self-report Average Number of Cigarettes Per Day|self-report from only the smoking population for cigarettes per day|12 weeks|only smokers|||cigarettes||Standard Error|Mean
1272020|NCT00342563|Primary|Self-report Weekly Smoking Craving|Questionnaire of smoking urges (QSU). It has 32 questions that range from 1 to 7, there are 8 questions per sub-scale. The total range is 32 to 224. Each sub-scale ranges from 8- 56, with a higher score indicating higher craving.|12 weeks|Smokers only|||units on a scale||Standard Error|Mean
1272021|NCT00342563|Primary|Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)|The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.|12 weeks|Scores presented are total, and then by subgroup.|||units on a scale||Standard Error|Mean
1272022|NCT00342563|Primary|Percent Heavy Drinking Days During Active Treatment Phase|Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) average during 90 days of treatment.|12 weeks||||days||Standard Error|Mean
1272023|NCT00342355|Primary|Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.|Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens.|January 2004 until March 31 2008||||participants|||Number
1272024|NCT00342355|Secondary|Serious Adverse Events|Safety outcomes in four different randomly assigned regimens|January 2004 until March 31, 2008||||participant|||Number
1272025|NCT00340834|Secondary|Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study|The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.|Baseline to end of study (up to approximately 4.5 years)|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1272026|NCT00340834|Secondary|Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study|The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Month 12 to end of study (up to approximately 3.5 years)|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.|||T2 lesions||Standard Deviation|Mean
1272027|NCT00340834|Secondary|Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.|Month 0 to end of study (up to approximately 4.5 years)|Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.|||Estimated relapses per year||95% Confidence Interval|Number
1272028|NCT00340834|Secondary|Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study|The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.|Baseline to Month 12|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1272029|NCT00340834|Secondary|Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study|The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Baseline to Month 12|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.|||T2 lesions||Standard Deviation|Mean
1272030|NCT00340834|Primary|Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.|Baseline to Month 12|Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.|||Estimate relapses per year||95% Confidence Interval|Number
1272031|NCT00340704|Secondary|RA,Cmax|The accumulation ratio was calculated from the patients who were randomised to the low dose group and for whom both parameters at first dose and steady state dose were available. Accumulation ratios of tamsulosin HCl in plasma at steady state after multiple dose administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose. The accumulation ratio RA,Cmax was calculated as: Cmax,ss/Cmax,1. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results from this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1272032|NCT00340704|Secondary|Vz/F,ss,W,Norm|Weight-normalized Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration), Vz/F,ss,W,norm. Weight-normalized VzF,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||L/kg||Geometric Coefficient of Variation|Geometric Mean
1272033|NCT00340704|Secondary|CL/F,ss,W,Norm|Weight-normalized CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration), CL/F,ss,W,norm. Weight-normalized CL/F,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
1272034|NCT00340704|Secondary|MRTpo,ss|Mean residence time of the analyte in the body at steady state after oral administration,MRTpo,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||hours||Geometric Coefficient of Variation|Geometric Mean
1272035|NCT00340704|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state, t1/2,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||hours||Geometric Coefficient of Variation|Geometric Mean
1272036|NCT00340704|Secondary|λz,ss|Terminal rate constant of the analyte in plasma at steady state, λz,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||1/hours||Geometric Coefficient of Variation|Geometric Mean
1272037|NCT00340704|Secondary|AUCτ ,ss ,DW ,Norm|Dose- and weight-normalized of AUCτ ,ss ( AUCτ ,ss ,DW ,norm). Weight normalization of AUCτ,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng*h/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
1272038|NCT00340704|Secondary|AUCτ,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ , AUCτ,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1272039|NCT00340704|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ, tmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||hours||Full Range|Median
1272040|NCT00340704|Secondary|Cmin,ss|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmin,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1272041|NCT00340704|Secondary|Cmax,ss, DW, Norm|Dose- and weight-normalized for Cmax,ss, Cmax,ss, DW, norm. Weight normalization of Cmax,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
1272042|NCT00340704|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1272043|NCT00340704|Secondary|Cpre,ss|Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose, Cpre,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS): This set includes subjects who were randomized successfully took study medication for two weeks at their randomized dose level and provided blood samples for PK at their steady state visit.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1272044|NCT00340704|Secondary|Cmax, 1 ,DW ,Norm|Dose- and weight-normalized Cmax,1 (Cmax,1,DW,norm). Weight normalization of Cmax,1 was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD)|||ng/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
1272045|NCT00340704|Secondary|Tmax, 1|Time from dosing to maximum measured concentration of the analyte in plasma after administration of the first dose, tmax, 1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD)|||hours||Full Range|Median
1272046|NCT00340704|Secondary|Cmax,1|Maximum measured concentration of the analyte in plasma following the first dose, Cmax,1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD): This set includes subjects who were randomized, successfully took and retained the first dose of study medication and provided blood samples for PK at Visit 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1272047|NCT00340704|Secondary|Vision Testing for Group D-527.51 Rollover|Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and Week 52|Treated Set (TS)|||Participants|||Number
1272048|NCT00340704|Secondary|Vision Testing for Group D-Denovo|Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-Denovo subjects, so results of this group is provided.|Baseline, Week 26 and Week 52.|Treated Set (TS)|||Participants|||Number
1272049|NCT00340704|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo|Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Subjects who experienced orthostatic hypotension during orthostatic testing were reported as adverse events. This Outcome Measure was only pre-specified for Group D-Denovo, so results of this group is provided.|From first drug administration until 28 days after last study drug administration, upto 450 days|Treated Set (TS)|||Participants|||Number
1272050|NCT00340704|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover|Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Below mentioned result are the number of subjects who had the clinical relevant abnormalities for the preferred term 'Hepatic enzyme increased'. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|From first drug administration until 28 days after last study drug administration, upto 395 days|Treated Set (TS)|||Participants|||Number
1272079|NCT00339144|Secondary|AUC (0-t) of Metabolite BMS-582691|AUC (0-t) was calculated using plasma concentration values of metabolite at time 0 to the time of the last measurable concentration (t).|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ng*hr/mL||Full Range|Geometric Mean
1272051|NCT00340704|Secondary|LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover|Response rates of LPP responders (2 LPP values < 40 cm H2O) at any time during the trial by treatment group. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2, 3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Week 1 to Week 52 (described study wise in the Description).|Full analysis set (FAS-LPP)|||participants|||Number
1272052|NCT00340704|Secondary|Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover|Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydronephrosis in the Group D-527.51 Rollover. Hydronephrosis response is defined as an improvement or stabilization based upon ultrasound grading at the end of the study. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization.|Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.|Full analysis set (FAS-RENAL). This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|||Participants|||Number
1272053|NCT00340704|Secondary|Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover|Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydroureter in the Group D-527.51 Rollover. Hydroureter response is defined as improvement or stabilization based upon the presence or absence of hydroureter at end of treatment compared to baseline. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.|Full analysis set (FAS-RENAL): Includes all patients in the Treated set who received one dose of treatment and had one on treatment renal measurement.|||Participants|||Number
1272054|NCT00340704|Secondary|Percent Change From Baseline in LPP for Group D-527.51 Rollover|Percent change from baseline in actual detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and Week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and Week 1|Full analysis set (FAS-LPP)|||percent change||Standard Deviation|Median
1272055|NCT00340704|Secondary|Change From Baseline in LPP for Group D-527.51 Rollover|Median change from baseline in detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and week 1|Full analysis set (FAS-LPP)|||cm H2O||Standard Deviation|Median
1272056|NCT00340704|Secondary|Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover|Early responders who maintained their detrusor leak point pressure (LPP) below 40 cm H2O during the study. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2,3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, However this endpoint was not analysed for Group D-527.51 Rollover as very limited data were collected due to early termination of the study & no alternative endpoint was defined in the Group D-527.51 rollover, so only the results for Group D-Denovo is provided.|Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).|Full analysis set (FAS-LPP)|||Participants|||Number
1272057|NCT00340704|Primary|Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.|Number of Leak point pressure (LPP) Responders at each visit (week) over time (classified by last value on treatment). Due to the early termination of the study, most of the LPP assessments were conducted within Weeks 1-9 of treatment. Summary of LPP response rates provided over time.The subjects are classified according to the treatment they were receiving at the last value on treatment. Therefore, no assumptions can be made regarding what dose they were receiving at a particular time point. LD: Low Dose, MD: Medium Dose and HD: High Dose This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.|Full analysis set (FAS-LPP)|||Participants|||Number
1282014|NCT00249249|Secondary|Triglycerides (TG)|mean triglycerides at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||mg/dL||Standard Deviation|Mean
1272058|NCT00340704|Primary|Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover|Group D-Denovo: Leak point pressure (LPP) Response at(response defined as a subject who achieves an LPP pressure <40 cm H2O) at the end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure <40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment, regardless of the length of treatment. Detrusor leak point pressure (LPP) recorded in cm H2O which was obtained using a standard urodynamic technique, a cystometrogram. Descriptive statistics were used to assess this endpoint. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.|Full analysis set (FAS-LPP): This subject set includes all subjects in the Treated set who received one dose of treatment and had one on treatment LPP measurement.|||percentage of responders|||Number
1272059|NCT00340678|Secondary|Glomerular Volume||6 years after first treatment|Intention-to-treat|||*10^6 cubic microns||Standard Deviation|Mean
1272060|NCT00340678|Primary|Number of Participants With Decline in GFR|Participants were monitored for up to 6 years. This is the number of participants who had a decline in GFR to less than or equal to 60 ml/min or to half the baseline value in subjects that enter the study with a GFR of less than 120 ml/min during the time of observation.|Up to 6 years|Intention-to-treat|||participants|||Number
1272061|NCT00340379|Primary|Brief Psychiatric Rating Scale at 12 Weeks|A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60.|12 weeks||||units on a Psychiatric Rating scale||Standard Deviation|Mean
1272062|NCT00340379|Primary|Clinical Global Impression Improvement Scale|A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse).|12 weeks||||units on a Clinical Impressions Scale||Standard Deviation|Mean
1272063|NCT00340379|Primary|21 Item Hamilton Depression Rating Scale|The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill).|12 week|Number of participants was ITT and imputed by LOCF|||Units on Hamilton Depression Scale||Standard Deviation|Mean
1272064|NCT00339833|Primary|Change in the Average Serum Insulin Concentration During the Last 40 Min of Clamp||last 40 min of clamp||||l/min||Standard Deviation|Mean
1272065|NCT00339833|Primary|Change in Fasting Plasma Glucose Concentration||7 days||||mmol/l||Standard Deviation|Mean
1272066|NCT00339183|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: “Is there a reasonable possibility that the event may have been caused by the study treatment?"|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.|Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.|||participants|||Number
1272067|NCT00339183|Secondary|Duration of Response|"Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Central Tumor Response Analysis Set: Responders|||months||95% Confidence Interval|Median
1272068|NCT00339183|Secondary|Time to Disease Progression|"Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
1272080|NCT00339144|Secondary|Cmax of Metabolite BMS-582691|Maximum plasma concentration was obtained from plasma concentration versus time data of metabolite (BMS-582691).|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ng/ml||Full Range|Geometric Mean
1272081|NCT00339144|Secondary|Mean Apparent Volume of Distribution (Vz/F) of Dasatinib|Apparent volume of distribution after oral dosing was obtained from plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||L||Full Range|Geometric Mean
1272069|NCT00339183|Secondary|Percentage of Participants With an Objective Response|Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.|Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.|KRAS Central Tumor Response Analysis Set: subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review for whom KRAS was assessed.|||percentage of participants||95% Confidence Interval|Number
1272070|NCT00339183|Primary|Overall Survival|Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
1272071|NCT00339183|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.|KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)|||months||95% Confidence Interval|Median
1272072|NCT00339144|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Within 4 weeks of first study drug administration, thereafter recorded every 4 or 8 weeks.|All treated participants with measurable disease at baseline and received at least one dose of the study drug (efficacy population).|||participants|||Number
1272073|NCT00339144|Secondary|Number of Participants With Sarcoma (Src) and Phosphorylated Src (pSRc) Protein Expression in Peripheral Blood Mononuclear Cells (PBMC)|Src and pSrc protein expression was planned to be evaluated in PBMC for establishing PK/PD relationship between Src/pSrc protein expression in PBMC and exposure of BMS-354825.|Plasma samples were collected on baseline (Day -1), 0 hour (pre-dose), 1 and 4 hours (post-dose) on Days 1, 14 and 28|All treated participants with adequate pharmacodynamic profiles. Participants could not be evaluated as the test was discontinued due to difficulty in appropriate measurements.|||participants|||Number
1272074|NCT00339144|Secondary|Mean Serum Concentration of Bone Alkaline Phosphatase (BAP) Biological Marker|BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism. Serum BAP was quantified with ELISA.|Serum samples were assessed on baseline (Day -1), and pre-dose on Days 14, 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||U/L||Standard Deviation|Mean
1272075|NCT00339144|Secondary|Mean Serum Concentration of Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP-5b) Biological Marker|TRACP-5b is a measure of bone metabolism. A decrease in TRACP-5b relative to the baseline indicates decrease in bone metabolism. Serum TRACP-5b was quantified with enzyme-linked-immunosorbent serologic assay (ELISA).|Serum samples were assessed at baseline (Day -1) and on Days 14 and 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||U/L||Standard Deviation|Mean
1272076|NCT00339144|Secondary|Mean Urine Concentration of Deoxypyridinoline (Dpyr) Biological Marker|Urine levels of DPyr is a measure of bone resorption. A decrease in Dpyr relative to the baseline indicates decrease in bone metabolism. Mean urine concentration of Dpyr biological marker was determined using ELISA.|Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6 12 and 24 hours post dose on Days 14 and 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||nanomol (nmol)/mL||Standard Deviation|Mean
1272077|NCT00339144|Secondary|Mean Urine Concentration of Urinary N-telopeptide Type 1 Collagen (NTx) Biological Marker|Urine NTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism. Mean urine concentration of NTx biological marker was determined using enzyme linked immuno-sorbent assay (ELISA).|Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28.|All treated participants with adequate pharmacodynamic (PD) profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||nmol*bone collagen equivalent (BCE)/mmol||Standard Deviation|Mean
1272078|NCT00339144|Secondary|Tmax of the Metabolite BMS-582691|Tmax of the metabolite was obtained using plasma concentration versus time data of metabolite BMS-582691.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||hours||Full Range|Median
1272117|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline at Each Time Point|sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.|||ratio||Standard Deviation|Mean
1272082|NCT00339144|Secondary|Mean Apparent Oral Clearance (CLo) of Dasatinib|Apparent oral clearance was obtained from the plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||L/hour||Full Range|Geometric Mean
1272083|NCT00339144|Secondary|Accumulation Index (AI) of Dasatinib|AI of Dasatinib was calculated as ratio of geometric mean of AUC(TAU) (area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration) on Day 14 or Day 28 on Day 1.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ratio||Full Range|Geometric Mean
1272084|NCT00339144|Secondary|Terminal Elimination Half-life (T-half) of Dasatinib|T-half of dasatinib was calculated using plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||hours||Standard Deviation|Mean
1272085|NCT00339144|Secondary|Time to Reach Maximum Observed Plasma Concentration of Dasatinib (Tmax)|Tmax, time to reach maximum observed plasma concentration of dasatinib was obtained directly from the plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||hours||Full Range|Median
1272086|NCT00339144|Secondary|AUC[TAU] of Dasatinib|Area under the plasma concentration-time curve within the dosing interval was determined. AUC(TAU), from time 0 to the time of the last measurable concentration (24 hours) was calculated for Day 1, 14, 28 respectively.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ng*hours/ml||Full Range|Geometric Mean
1272087|NCT00339144|Secondary|Area Under the Plasma-concentration-time Curve [AUC (INF)] of Dasatinib on Day 1|AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Day 1.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Day 1|All treated participants with adequate PK profiles (PK population).|||ng*hours/ml||Full Range|Geometric Mean
1272088|NCT00339144|Secondary|Maximum Plasma Concentration (Cmax) of Dasatinib|Cmax was obtained from the plasma concentration versus time data after oral administration of dasatinib.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate pharmacokinetic (PK)profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||nanograms (ng)/ml||Full Range|Geometric Mean
1272089|NCT00339144|Secondary|Number of Participants With Clinically Significant Change in QT Interval Corrected for Heart Rate (QTcF)|QT interval corrected for heart rate (QTcF) was assessed using triplicate 12-lead serial ECGs.|Baseline, Day 1, Day 14 and Day 28|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
1272090|NCT00339144|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Standard 12-lead ECG was used to record selected ECG parameters like RR interval (the time between the two R waves in ECG), PR interval (interval measured from the beginning of the P wave to the beginning of the QRS complex; QRS complex is the name for some of the deflections seen on a typical ECG)), QRS duration, QT interval (time between onset of ventricular depolarization and end of ventricular repolarization), QT interval corrected for heart rate using Bazett's (QTcB) and Fridericia's (QTcF) formulas.|From screening Day -1, and at pre-dose, 1 and 4 hours (post-dose) on Days 1, 14 and 28 in first treatment course, at pre-dose, 1 and 4 hours (post-dose) during the second and fourth week in subsequent courses and at the end of study|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
1272091|NCT00339144|Secondary|Number of Participants With Clinically Meaningful Vital Signs|Vital signs measurements (including blood pressure, body temperature and pulse rate) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs were clinically significant.|From screening, Day 1 , 8, 15 and 22 in the 1st treatment course, Day 8 and 22 in the second and subsequent courses and at the end of study|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
1272092|NCT00339144|Secondary|Number of Participants With Clinically Meaningful Physical Examination Measures|Interim and final physical examinations were performed. The investigator used his/her clinical judgment to decide whether or not physical examination findings were clinically significant.|From screening, Day 1 in each treatment course and at the end of study|All participants who received at least one dose of the study drug (safety population). Analysis for significant physical examination findings was not done.|||participants|||Number
1272093|NCT00339144|Secondary|Most Frequent Serum Chemistry Laboratory Abnormalities Occurring in >=10% Participants: High Magnesium|Abnormalities were graded according to the NCI-CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Most frequent (>=10%) serum laboratory abnormalities were recorded. The following definitions specify the NCI-CTC AE criteria for serum laboratory abnormalities in the data presented: magnesium: Grade 3: >3.0 - 8.0 mg/dL or >1.23 - 3.30 mmol/L, Grade 4: >8.0 mg/dL or >3.30 mmol/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
1272118|NCT00338884|Secondary|sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL||Full Range|Median
1272094|NCT00339144|Secondary|Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=10% Participants: Low Lymphocyte Count|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Most frequent hematology Grade 3 and 4 abnormalities occurring in >=10% participants were recorded. Grade 3 and 4 criteria are as follows: lymphocyte count: Grade 3: 0.2 - <0.5*10^9/L, Grade 4: <0.2*10^9/L.|From start of study drug therapy up to 30 days after the last dose.|All treated participants who received at least one dose of the study drug.|||participants|||Number
1272095|NCT00339144|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-<2.0 mg/dL, Grade 4: <1.0 mg/dL; calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; magnesium: Grade 3: >3.0 – 8.0 mg/dL or >1.23 – 3.30 mmol/L, Grade 4: >8.0 mg/dL or >3.30 mmol/L; albumin: Grade 3: <2 g/dL or <20 g/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug.|||participants|||Number
1272096|NCT00339144|Secondary|Number of Participants With Grade 3 or 4 Hematology Abnormalities|Hematology abnormalities were graded per the National Cancer Institute (NCI) Common. Terminology Criteria (CTC) version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L; lymphocytes: Grade 3: 0.2 - <0.5*10^9/L, Grade 4: <0.2*10^9/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug.|||participants|||Number
1272097|NCT00339144|Secondary|Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs (SAEs), Drug Related AEs and Discontinued Due to AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs: events with a relationship to the study therapy of certain; probable; possible; not likely or unrelated.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
1272098|NCT00339144|Primary|Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to Dasatinib Treatment|MAD: highest dose level at which >=1 DLTs were reported, MTD: dose one step lower than MAD. DLT: any of the following considered related to dasatinib during course 1:Grade 3(dose reduction by 1 dose level)/Grade 4:recurring nausea, vomiting or diarrhea; any other Grade >=3 non-hematologic toxicity except alopecia or fatigue;any grade toxicity requiring two dose reductions or participant's discontinuation; Grade 4 neutropenia <500 cells/mm^3 for >=5 consecutive days or febrile neutropenia; Grade 4 thrombocytopenia <25,000 cells/mm^3 or Grade 3 bleeding requiring platelet transfusion.|From start of the treatment i.e.Day 1 to end of Cycle 1 i.e. Day 30 (4 weeks)|All treated participants who received at least one dose of the study drug and were evaluable for DLT.|||participants|||Number
1272099|NCT00339079|Secondary|Columbia Heightened Illness Concern - Obsessive-Compulsive Scale|The Columbia Heightened Illness Concern - Obsessive-Compulsive Scale was the name for an earlier version of the H-YBOCS-M. The H-YBOCS-M is an expanded version and has additional items not included in the Columbia Heightened Illness Concern OCS. We did not administer the CHIC-OCS to patients in this study.|Not measured|||||||
1272100|NCT00339079|Primary|25% Improvement on Both Whiteley Index and H-YBOCS-M|Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis|Measured at Week 24||||Participants|||Count of Participants
1272101|NCT00339040|Secondary|HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing HIV-1 viral load.|||Log10(copies/mL)||95% Confidence Interval|Log Mean
1272102|NCT00339040|Secondary|CD4 Percent Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing CD4%.|||percentage of total lymphocytes||95% Confidence Interval|Mean
1272103|NCT00339040|Secondary|CD4 Count Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing CD4 counts.|||cells/µL||95% Confidence Interval|Mean
1272104|NCT00339040|Primary|Serum Anti-HPV Antibody Titers (cLIA)|Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)|Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.|The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline as well as any participants with any missing values at any time points.|||milli-Merck units [mMU]/mL||95% Confidence Interval|Geometric Mean
1272105|NCT00339040|Primary|Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion|Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units [mMU]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.|At week 28 after beginning the vaccination series|The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline.|||percent of participants||95% Confidence Interval|Number
1272119|NCT00338884|Secondary|sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)|Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL||Full Range|Median
1272120|NCT00338884|Secondary|Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline||Baseline|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.|||pg/mL||Standard Deviation|Mean
1272106|NCT00339040|Primary|Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, Treatment related, Non-treatment related, Baseline, Possibly treatment related."|Within 14 days of first three doses of vaccination|Any participant who received at least one study vaccine/placebo were included in the safety analysis|||percent of participants||95% Confidence Interval|Number
1272107|NCT00339040|Primary|Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. All grade 3 and higher signs, symptoms, and laboratory toxicities were included."|Within 14 days of first three doses of vaccination|Any participant who received at least one study vaccine/placebo were included in the safety analysis.|||percent of participants||95% Confidence Interval|Number
1272108|NCT00338988|Primary|Number of Participants With Objective Response|Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline with restaging every 3 cycles (cycle=21 days)|Analysis was per protocol. One participant was found ineligible and received no treatment.|||participants|||Number
1272109|NCT00338962|Primary|Mean Number of Side Effects|Differences in mean number of side effects reported for each group. Side effects and common adverse symptoms were evaluated by the research staff weekly, using a modified version of the ystematic Assessment for Treatment Emergent Events. The symptoms that are known to be associated with treatment with desipramine, paroxetine, and naltrexone were specifically screened or on a weekly basis. The symptoms were then clustered into the following categories: gastrointestinal, emotional, cold and flu symptoms, skin, sexual, neurological, and cardiac.|12 weeks||||side effects||Standard Error|Mean
1272110|NCT00338962|Primary|Hamilton Depression Rating Scale (HAM-D)|The HAM-D ranges from 0 (Normal) to >23 (Very Severe Depression)|beginning of treatment (week 1), and end of treatment (13 weeks)||||units on a scale||Standard Error|Mean
1272111|NCT00338962|Primary|Clinician-Administered PTSD Scale (CAPS)|"The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to:~Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD"|beginning of treatment (week 1), and end of treatment (13 weeks)||||units on a scale||Standard Error|Mean
1272112|NCT00338962|Primary|Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)|The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.|beginning of treatment (week 1), and end of treatment (13 weeks)||||units on a scale||Standard Error|Mean
1272113|NCT00338884|Secondary|Cancer Related Symptoms, Well-Being, and Concerns|FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.|Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)|Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.|||scores on a scale||Standard Deviation|Mean
1272114|NCT00338884|Secondary|Patient-Assessed Fatigue|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.|Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)|Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.|||scores on a scale||Standard Deviation|Mean
1272115|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.|||ratio||Full Range|Median
1272116|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)|Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.|||ratio||Full Range|Median
1272121|NCT00338884|Secondary|VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.|||ratio||Full Range|Median
1272122|NCT00338884|Secondary|VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)|Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.|||ratio||Full Range|Median
1272123|NCT00338884|Secondary|VEGF Ratio to Baseline at Each Time Point|VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.|||ratio||Standard Deviation|Mean
1272124|NCT00338884|Secondary|VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL||Full Range|Median
1272125|NCT00338884|Secondary|VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)|Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL||Full Range|Median
1272126|NCT00338884|Secondary|Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline||Baseline|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.|||picograms (pg)/mL||Standard Deviation|Mean
1272127|NCT00338884|Secondary|Ctrough Correlated With Serious Adverse Events (SAEs)|Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|Ctrough correlation analyses with SAEs were not performed due to low frequency of individual SAEs.||||||
1272128|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
1272129|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
1272130|NCT00338884|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.|||ng/mL||Standard Deviation|Mean
1272131|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
1272132|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
1272133|NCT00338884|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.|||ng/mL||Standard Deviation|Mean
1272134|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
1272135|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
1272136|NCT00338884|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
1272137|NCT00338884|Secondary|1-Year Survival|One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year|Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis.|||percent chance of survival||95% Confidence Interval|Median
1272138|NCT00338884|Secondary|Progression-Free Survival (PFS)|Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death|Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis.|||months||95% Confidence Interval|Median
1272139|NCT00338884|Secondary|Time to Tumor Progression (TTP)|Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter|Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis.|||months||95% Confidence Interval|Median
1272140|NCT00338884|Secondary|Duration of Response (DR)|Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause|Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response.|||months||95% Confidence Interval|Mean
1272141|NCT00338884|Primary|Number of Subjects With Overall Confirmed Objective Response (OR)|OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter|Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis.|||participants|||Number
1272142|NCT00338806|Secondary|Treatment Credibility Scale|Treatment Credibility Questionnaire. Participant and parent’s expectancy about the perceived benefit of treatment will be assessed following the first intervention session after the treatment rationale is given. Adolescents were asked to rate how logical the treatment seemed to them, how confident they were that it would be successful, and how confident they would be in recommending the treatment to a friend. A 0- to 2-point rating scale (0 = none, 1 = some, 2 = a lot) was used (range of possible overall score 0-6, higher score indicating higher treatment credibility)|Measured at Week 1|An ECM participant did not fill out her form|||units on a scale||Standard Deviation|Mean
1272143|NCT00338806|Secondary|Social Rhythm Metric Short Form|The Social Rhythm Metric Short Form (SRM-Short Form) measures habitual time at which 5 daily events occur in a person’s life over a one-week interval: what time the adolescent gets out of bed, makes first contact with another person, starts school, has dinner, and goes to bed.|Measured at Week 12 and Months 6, 12, and 18 post-treatment|Participants were not filling out form (it required documentation during the week) and reconstructing it in the meetings with the clinician proved to be too time consuming. Measure was withdrawn from the assessment battery||||||
1272144|NCT00338806|Secondary|Social Adjustment Scale - Self Report for Adolescents|(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.|12 months and 18 months|At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)||||||
1272145|NCT00338806|Secondary|Social Adjustment Scale - Self Report for Adolescents|(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.|Measured at Week 12||||units on a scale||Standard Deviation|Mean
1272146|NCT00338806|Secondary|Patient Health Questionnaire|The PHQ-9 is a depression screen, administered to the adolescents parents in this study. The PHQ-9 scores each of the 9 DSM-IV criteria as “0” (not at all) to “3” (nearly every day). Scores can range from 0-27, with higher score indicating higher depression levels.|Measured at Week 1||||units on a scale||Standard Deviation|Mean
1272147|NCT00338806|Secondary|Mood Disorder Questionnaire|A self-report inventory for the participant' parent that screens for history of a manic or hypomanic syndrome by including 13 yes/no items. A score >7 indicate possible history of mania/hypomania (coded as 1), <7 indicates potential absence of mania/hypomania (coded as 0)|Week 1|This measure reflects parental mood.expressed as number of participants whose parent with BDI or BDII endorsed > 7(1)|||participants|||Number
1272148|NCT00338806|Secondary|Family History Screen|A clinician-administered instrument to the adolescent' parent, designed to screen for mood, anxiety, and other disorders in parent’s first-degree relatives (parents, spouse).|Measured at Week 1 (baseline)||||participants|||Number
1272149|NCT00338806|Secondary|Family Assessment Device|The General Functioning scale, that assesses the overall health/pathology of the family, is used for the study. The 12 item scores are averaged to calculate the total score, which ranges from 1-4, with higher scores reflecting worse functioning|Measured at Week 12||||units on a scale||Standard Deviation|Mean
1272150|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self report 10-item scale designed to measure respondents’ tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).~Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|12 months and 18 months|At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)||||||
1272151|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self-report10-item scale designed to measure respondents’ tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).~Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|6 months||||units on a scale||Standard Deviation|Mean
1272152|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self report 10-item scale designed to measure respondents’ tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).~Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|Measured at Week 12|Data were not collected for 6 and 12 month time points|||units on a scale||Standard Deviation|Mean
1272153|NCT00338806|Secondary|Attitudes Toward Treatment Questionnaire|A 4 item measure to evaluate attitudes towards: length of treatment, helpfulness of therapist, effects of participating in research, and additional services desired. Each item had 3 response options: 1.positive (or longer treatment) 2.neutral (or length just right) 3. negative (or shorter treatment). Scores are summed with potential range from 4-12. Lower number indicates more positive attitude|Measured at Week 12||||units on a scale||Standard Deviation|Mean
1272154|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|18 months|At the 18 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
1272155|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|12 months|At the 12 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
1272156|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|6 months||||units on a scale||Standard Deviation|Mean
1272157|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
1272158|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|18 months|At the 18 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
1272159|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|12 months|At the 12 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
1272160|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|6 months||||units on a scale||Standard Deviation|Mean
1272161|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|Week 12||||units on a scale||Standard Deviation|Mean
1272162|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|18 months|At the 18 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
1272163|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|12 months|At the 12 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
1272164|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|6 months||||units on a scale||Standard Deviation|Mean
1272165|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|Week 12||||units on a scale||Standard Deviation|Mean
1272166|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|18 months|At the 18 month follow up point only 1 participant was available and willing be assessed.|||participants|||Number
1272167|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|12 months|At the 12 month follow up timepoint only 1 participant was available and willing to be assessed.|||participants|||Number
1272168|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|6 months||||participants|||Number
1272169|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|12 weeks||||participants|||Number
1272170|NCT00338741|Secondary|Fetal Death/Stillbirth|Fetal death/stillbirth|Up to 10 months||||Participants|||Number
1272171|NCT00338741|Primary|Spontaneous Abortion|Number of participants having spontaneous abortion|Up to 9 months|Population includes all subjects for whom data is available|||Participants|||Number
1272172|NCT00338598|Secondary|Baseline and End of Treatment Neurophysiological Measures||12 weeks|Data was not collected||||||
1272173|NCT00338598|Secondary|Baseline and End of Treatment Quality of Life||12 weeks|Data was not collected||||||
1272174|NCT00338598|Secondary|Weekly Drug Use||12 weeks|Data was not collected||||||
1272175|NCT00338598|Primary|Baseline and End of Treatment Cognitive Functioning Measures (Hopkins)|Hopkins Verbal Learning Test Assesses short term verbal learning and memory. Subscales include immediate recall (0-36), delayed recall (0-12) , and recognition (0-12). A higher score indicates better memory performance.|12 weeks||||units on a scale||Standard Error|Mean
1272176|NCT00338598|Primary|Weekly Ratings of Negative/Positive Psychotic Symptoms|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms for each scale.|12 weeks||||units on a scale||Standard Error|Mean
1272177|NCT00338598|Primary|Self Reported Weekly Alcohol Craving|The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.|12 weeks||||units on a scale||Standard Error|Mean
1272178|NCT00338598|Primary|Self Reported Weekly Alcohol Consumption|Percentage of drinking days and heavy drinking days using timeline follow back|12 weeks||||percentage of days||Standard Error|Mean
1272179|NCT00338455|Secondary|Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean||28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.||||||
1272180|NCT00338455|Secondary|All Cause Mortality||Day 30 and Months 2 and 6|Early termination of the study due to enrollment difficulties; efficacy not analyzed.||||||
1272181|NCT00338455|Secondary|Changes in Pulmonary Capillary Wedge Pressure (PCWP)||28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.||||||
1272182|NCT00338455|Primary|Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment)|Number of calendar days alive without renal, hemodynamic, or electrical clinical worsening through Day 28 (termination of treatment or early discontinuation of treatment, whichever occurred first). The endpoint was not normalized for time on study.|28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.||||||
1272183|NCT00338286|Secondary|Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)|Suspected TVEs were identified by investigators and relevant clinical information was collected.|up to 8.4 years|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Percentage of participants|||Number
1272198|NCT00337818|Secondary|Number of Subjects Reporting SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort of each time point.|||Subjects|||Number
1272337|NCT00336583|Secondary|Worst Toxicity Grade by Patient|graded by National Cancer Institute Common Toxicity Criteria of Adverse Event version 3.0|up to 24 weeks|The 27 patients received a total of 103 cycles of the ESHAOx treatment, with a median number of four cycles per patient. Except one who was lost to follow-up after one cycle, 26 patients were assessable for toxicity.|||participants|||Number
1272184|NCT00338286|Secondary|Overall Response Rate (ORR)|Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter <20 millimeter (mm) with conventional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions.|every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Percentage of participants|||Number
1272185|NCT00338286|Secondary|Time to Tumor Progression|The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD).|From date of randomization to the date of the first documented PD (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Months||95% Confidence Interval|Median
1272186|NCT00338286|Secondary|Overall Survival|Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the final database lock, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the final database lock, OS was censored at the date of final database lock.|From randomization up to death from any cause (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Months||95% Confidence Interval|Median
1272187|NCT00338286|Primary|Progression Free Survival|Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.|From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Months||95% Confidence Interval|Median
1272188|NCT00338104|Secondary|Percentage of Glucose Levels > 180 mg/dL|Percentage of blood glucose levels > 180 mg/dL|First 24 hours after conversion||||percentage of blood glucose values|||Number
1272189|NCT00338104|Secondary|Percentage of Glucose Values < 50 mg/dL|Percentage of blood glucose values < 50 mg/dL|First 24 hours after conversion||||percentage of blood glucose values|||Number
1272190|NCT00338104|Primary|Percentage of Blood Glucose Values Between 80 - 140|Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL|First 24 hours after conversion||||percentage of blood glucose values|||Number
1272191|NCT00338039|Primary|Median Overall Survival|Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death.|Baseline to disease progression or death, up to 4 years||||Months||95% Confidence Interval|Median
1272192|NCT00338039|Primary|Overall Survival Rate|1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.|1 to 4 years||||percentage of participants|||Number
1272193|NCT00337987|Primary|Number of Patients That Achieved a Complete Response (CR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 4 years||||participants|||Number
1272194|NCT00337987|Primary|Number of Patients That Achieved a Complete Response or a Partial Response (PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 4 years||||participants|||Number
1272195|NCT00337935|Secondary|Time to Hemoglobin Response|Time to hemoglobin reponse was defined as the time between individual treatment start date and the first of 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL. Note: Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.|Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.|||Days||95% Confidence Interval|Median
1272196|NCT00337935|Secondary|The Number of Patients Achieved a Hemoglobin Response.|Hemoglobin reponse was defined as 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL|Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.|||participants|||Number
1272197|NCT00337935|Primary|Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)||Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.|||g/dL||Standard Deviation|Mean
1274796|NCT00317941|Other Pre-specified|Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors|Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis|Up to 3 months||||Scores on a scale|Participants|Standard Deviation|Mean
1272199|NCT00337818|Secondary|Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.|Throughout the study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.|||Subjects|||Number
1272200|NCT00337818|Secondary|Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Months 24, 36 and 48|Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1272201|NCT00337818|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At months 24, 36, and 48|Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1272202|NCT00337818|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).~*Data for Month 18 outcome variables were incorporated into the Month 24 analyses."|At months 18*, 24, 36 and 48|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1272203|NCT00337779|Secondary|The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).|"The Frequent MRI Cohort was a subset of subjects consisting of 234 subjects, for whom MRI scans were performed at months 0 (baseline), 1, 2, 3, 6, 9 and 12. Analysis of the endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression with an offset variable employing the log of the porportion of the number of available post-baseline scans to adjust for missing MRI scans (if any) and including the number of T1 Gd-enhancing lesions at baseline and (pooled) center as covariates."|12 months|Frequent MRI cohort|||T1 Enhancing Lesions||Standard Deviation|Log Mean
1272204|NCT00337779|Secondary|The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.|The analysis of this endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression including the number of T1 Gd-enhancing lesions at baseline, the volume of T2 lesions at baseline and (pooled) center as covariates.|12 months||||T2 Lesions||Standard Deviation|Mean
1272205|NCT00337779|Primary|The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).|A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.|12 months|ITT|||Number of relapses per patient||Standard Deviation|Mean
1272206|NCT00337727|Secondary|Number of Patients Who Reported Complete Response|The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.|Overall phase (0-120 hours post initiation of MEC) in Cycle 1|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received MEC, (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.|||Participants|||Number
1272207|NCT00337727|Primary|Number of Patients Who Reported No Vomiting|"The number of patients who reported No Vomiting in the overall phase in Cycle~1"|Overall phase (0-120 hours post initiation of MEC) in Cycle 1.|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderately Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.|||Participants|||Number
1272208|NCT00337675|Secondary|Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes|Each day during an asthma episode, the patient’s legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.|1 Year|Patients with at least one episode culminating in an attack were included; therefore, 1120 patients were included in the analysis.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1272209|NCT00337675|Secondary|Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode|Each day during an asthma episode, the patient’s legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.|1 Year|Only patients who experienced an asthma attack within an episode and did not start their intermittent study medication on the day of the attack could be included. Therefore, a total of 452 patients were included in this analysis.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1272223|NCT00337662|Secondary|Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission|'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
1272210|NCT00337675|Primary|Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period|The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient’s legal guardian recorded all the HRU that was required specifically for breathing problems.|1-year treatment period|Full Analysis Set (FAS): all randomized patients who took at least one dose of blinded study drug. Of 1771 patients randomized, 5 never took study drug and 9 were not included due to Good Clinical Practice compliance concerns. Therefore, 1757 patients were included in the FAS population.|||Asthma attacks within episodes per year||95% Confidence Interval|Mean
1272211|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight|Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||kilograms||Standard Deviation|Mean
1272212|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure|Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||mm Hg||Standard Deviation|Mean
1272213|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate|Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||beats per minute||Standard Deviation|Mean
1272214|NCT00337662|Secondary|Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure|Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||mm Hg||Standard Deviation|Mean
1272215|NCT00337662|Secondary|Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure|Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5- visit 9) visits.|||mm Hg||Standard Deviation|Mean
1272216|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate|Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||beats per minute||Standard Deviation|Mean
1272217|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score|A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||units on a scale||Standard Deviation|Mean
1272218|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score|Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||units on a scale||Standard Deviation|Mean
1272219|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale|Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||units on a scale||Standard Deviation|Mean
1272220|NCT00337662|Secondary|Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants|Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.|Week 2 to Week 12|Total number of patients with the lab test at baseline and post-baseline.|||participants|||Number
1272221|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index|Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||kilogram per square meter||Standard Deviation|Mean
1272222|NCT00337662|Secondary|Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups|Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
1272318|NCT00336817|Other Pre-specified|Incidence of Biopsy-proven Acute Cellular Rejection During the Study Period|number of patients with ACR|12 weeks||||participants|||Number
1272224|NCT00337662|Secondary|Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission|'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
1272225|NCT00337662|Secondary|The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score|The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
1272226|NCT00337662|Secondary|The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score|The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
1272227|NCT00337662|Secondary|Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients|Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2).|Weeks 2, 3, 4, 6, 8, 12|Intention to treat patients with both baseline and postbaseline assessment|||units on a scale||Standard Error|Least Squares Mean
1272228|NCT00337662|Primary|Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients|Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).|Weeks 0, 3, 4, 6, 8, 12|Intention to treat for patients with both baseline and any postbaseline assessment|||units on a scale||Standard Error|Least Squares Mean
1272229|NCT00337610|Secondary|Change From Baseline in A1C at Week 30|A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.|Baseline and Week 30|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.|||Percent||95% Confidence Interval|Least Squares Mean
1272230|NCT00337610|Secondary|Change From Baseline in 2 Hr-PMG at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1272231|NCT00337610|Secondary|Change From Baseline in FPG at Week 18|Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1272232|NCT00337610|Primary|Change From Baseline in A1C at Week 18|A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward (LOCF) method.|||Percent||95% Confidence Interval|Least Squares Mean
1272233|NCT00337571|Secondary|Change From Baseline in Body Weight|Adjusted mean change (Week 8 - baseline) in body weight|Week 8|Safety population=all randomized participants minus 3 patients in the placebo group (1 no longer met study criteria, 2 did not have measurement at baseline and Week 8), and 1 participant in the 5-mg group who withdrew consent. Data set is LOCF.|||kilograms||Standard Error|Mean
1272234|NCT00337571|Secondary|Summary of Safety|Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation|continuously throughout the study|Safety population=all randomized participants minus 1 patients in the placebo group (no longer met study criteria), and 1 participant in the 5-mg group who withdrew consent.|||participants|||Number
1272235|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient’s improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
1272319|NCT00336817|Other Pre-specified|Incidence of Graft Loss or Death During the Study Period|number of patients|12 weeks||||participants|||Number
1272320|NCT00336817|Secondary|Number of Participants With Neurotoxicity||12 weeks||||participants|||Number
1272236|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores|Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
1272237|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)|CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
1272238|NCT00337571|Secondary|Number of Participants With Response at Week 8|Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||Participants|||Number
1272239|NCT00337571|Secondary|Mean Clinical Global Impressions Improvement Scale (CGI-I) Score|The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
1272240|NCT00337571|Primary|Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score|The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
1272241|NCT00337467|Secondary|Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96|International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.|Week 96|Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.|||participants|||Number
1272242|NCT00337467|Secondary|Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48|International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.|Week 48|Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.|||participants|||Number
1272243|NCT00337467|Secondary|Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96|Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.|Baseline, Week 96|n=number of treated participants with baseline measure and measure at Week 96|||percent change||Standard Deviation|Mean
1272244|NCT00337467|Secondary|Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48|Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.|Baseline, Week 48|n= number of treated participants with baseline measure and measure at Week 48|||percent change||Standard Deviation|Mean
1272245|NCT00337467|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).|From Baseline through Week 96|Treated Participants|||percentage of participants|||Number
1272246|NCT00337467|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 96||Baseline, Week 96|n=number of participants with CD4 cell count at baseline and at Week 96.|||cells /mm3||Standard Deviation|Mean
1272247|NCT00337467|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 48||Baseline, Week 48|n=number of participants with CD4 cell count at baseline and at Week 48.|||cells /mm3||Standard Deviation|Mean
1272248|NCT00337467|Secondary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24||Baseline, Week 24|n=number of participants with CD4 cell count at baseline and at Week 24|||cells /mm3||Standard Deviation|Mean
1272321|NCT00336817|Secondary|Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12|Creatinine levels|12 weeks||||participants|||Number
1272322|NCT00336817|Secondary|Drug Discontinuation Due to Side Effects|Drug discontinuation due to drug side effects regarding Cellcept and Myfortic.|12 weeks||||Participants|||Count of Participants
1272249|NCT00337467|Secondary|Proportion of Participants With Virologic Rebound Through Week 96|Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.|Through Week 96|This analysis was not done; however, percentage of participants with virologic rebound through Weeks 48 and 96 are reported in Secondary Outcome Measures 3 and 4. Time to reatment failure (defined as the earlier of virologic rebound or treatment discontinuation) is reported in Secondary Outcome Measure 5.|||proportion of participants|||Number
1272250|NCT00337467|Secondary|Cumulative Proportion of Participants Without Treatment Failure Through Week 100|This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).|Through Week 100|treated participants; n= the number at risk entering interval|||proportion of participants|||Number
1272251|NCT00337467|Secondary|Percentage of Participants With Virological Rebound Through Week 96|Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.|Week 96|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.|||percentage of participants|||Number
1272252|NCT00337467|Secondary|Percentage of Participants With Virological Rebound Through Week 48|Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.|Week 48|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.|||percentage of participants|||Number
1272253|NCT00337467|Secondary|Percentage of Participants With Treatment Failure Through Week 96|Treatment Failure through Week 96 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA >= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA < 50 c/mL.|Week 96|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.|||percentage of participants|||Number
1272254|NCT00337467|Primary|Percentage of Participants With Treatment Failure Through Week 48|Treatment Failure through Week 48 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy.|Week 48|Treated participants|||Percentage of Participants|||Number
1272255|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||ELISA units/mL||95% Confidence Interval|Mean
1272256|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||ELISA units/mL||95% Confidence Interval|Mean
1272257|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||ELISA units/mL||95% Confidence Interval|Mean
1272258|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||ELISA units/mL||95% Confidence Interval|Mean
1272323|NCT00336817|Primary|Incidence of Cytomegalovirus Infection or Disease During the Study Period|number of participants|12 weeks||||participants|||Number
1282015|NCT00249249|Secondary|TC:HDL-C Ratio|Ratio of mean total cholesterol to mean HDL-C at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||ratio||Standard Deviation|Mean
1272259|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
1272260|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
1272261|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
1272262|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™|Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
1272263|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™|Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
1272264|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||participants|||Number
1272265|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||participants|||Number
1272324|NCT00336817|Primary|Number of Participants With Bone Marrow Suppression|Number of participants with: Thrombocytopenia (<50,000 mm3), Leukopenia (< 2000 mm3), absolute neutrophils count ( <1000 mm3) or hemoglobin ( < 7.0 g/dL)|12 weeks||||participants|||Number
1272266|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||participants|||Number
1272267|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||participants|||Number
1272268|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||milliMerck units/mL||95% Confidence Interval|Mean
1272269|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||milliMerck units/mL||95% Confidence Interval|Mean
1272270|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||milliMerck units/mL||95% Confidence Interval|Mean
1272271|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||milliMerck units/mL||95% Confidence Interval|Mean
1272272|NCT00337350|Primary|Change From Baseline in Acute Insulin Response to Glucose (AIRG)|Acute insulin response to glucose (AIRG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. AIRG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. AIRG measures the acute(0–10 min) beta\ cell response to a glucose load calculated by the areas under the curve higher than basal insulin values. The AIRG was assessed as the incremental area under the curve (calculated by the trapezoid rule) from 0 to 10 min of the FSIVGTT.|baseline, week 8||||Units/mL per 10 minutes||Standard Deviation|Mean
1272273|NCT00337350|Primary|Change From Baseline on Glucose Utilization (SG)|Glucose utilization (SG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. SG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SG represents the net fractional glucose clearance rate because of the increase in glucose independent of any increase in circulating insulin concentrations above baseline.|baseline, week 8||||min^-1||Standard Deviation|Mean
1275127|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|12 weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
1272274|NCT00337350|Primary|Change From Baseline in Insulin Sensitivity|Insulin Sensitivity (IS) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in IS between Baseline and week 8. SI was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SI represents the increase in net fractional glucose clearance rate per unit change in serum insulin concentration after the intravenous glucose load (microUnits/mL).|baseline, week 8||||microUnits/mL||Standard Deviation|Mean
1272275|NCT00337285|Secondary|Change in PSQI Total Score From Baseline at Up to One Year|Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.|up to 1 year|Safety population (Defined as all subjects who were enrolled and who received at least one dose of the investigational product.)|||Units on a scale||Standard Deviation|Mean
1272276|NCT00337285|Secondary|Number of Participants With Improvement on CGI-I|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.|Up to 1 year|ITT|||Participants|||Number
1272277|NCT00337285|Primary|Change in ADHD-RS-IV Total Score From Baseline at Up to One Year|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|up to one year|Intent-to-treat (ITT). Defined as all subjects who were treated and had both the baseline and at least one post-baseline primary efficacy measurement (i.e., ADHD-RS-IV total score)|||Units on a scale||Standard Deviation|Mean
1272278|NCT00337272|Secondary|Daytime Function - Distress|The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.|||Units on a Scale||Standard Deviation|Mean
1272279|NCT00337272|Secondary|Daytime Function - Despair|The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.|||Units on a Scale||Standard Deviation|Mean
1272280|NCT00337272|Secondary|Daytime Function - Fatigue|The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 12 patients with 6 treated with Placebo and 6 with Ramelteon. Treatment period: 11 patients with 4 treated with Placebo and 7 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.|||Units on a Scale||Standard Deviation|Mean
1272281|NCT00337272|Secondary|Qualitative Evaluation of Sleep - Quality of Sleep|The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.|||Units on a Scale||Standard Deviation|Mean
1272282|NCT00337272|Secondary|Qualitative Evaluation of Sleep - Global Sleep Impression|"The Patient Global Impression is a 7-point scale which asks How much has your sleep improved? with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement."|Once during the withdrawal period||||Participants|||Number
1272283|NCT00337272|Secondary|Quantitative Sleep Parameters - Number of Awakenings|The subject reports how many times she woke up during the night.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.|||Awakenings||Standard Deviation|Mean
1272284|NCT00337272|Secondary|Quantitative Sleep Parameters - Total Sleep Time|The subject reports how many hours of sleep she got.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.|||Hours||Standard Deviation|Mean
1272285|NCT00337272|Primary|Sleep Efficiency|Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed).|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.|||Percent sleep efficiency||Standard Deviation|Mean
1272286|NCT00337207|Primary|Tumoral Blood Flow Changes|To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.|Before and after treatment|This was an optional outcome measure. Data was not collected or analyzed for this outcome measure.||||||
1272287|NCT00337207|Primary|Progression-free Survival at 6 Months|The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.|After all patients have surpassed the 6 month post-treatment timepoint|1 patient became deceased due to toxicity prior to the 6 month time point and thus, was not evaluable for the 6 month progression free survival endpoint.|||Participants|||Number
1272288|NCT00337207|Primary|Safety of Treatment|"Safety of treatment will be defined by the number of patients that experience grade 3 and 4 adverse events where causal relationship with bevacizumab cannot be completely ruled out. Adverse events will be graded using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.|All patients that receive at least one dose of study treatment are evaluable for toxicity|||participants|||Number
1272289|NCT00337194|Other Pre-specified|Fc Gamma Receptor Polymorphisms|Fisher’s exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a|Baseline|Fc gamma receptor polymorphisms were assessed in 28 participants.|||participants|||Number
1272290|NCT00337194|Other Pre-specified|sCD30 Levels|A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups.|Up to day 21 of course 6|Nine participants submitted pretreatment sCD30 samples.|||U/ml||Full Range|Median
1272291|NCT00337194|Other Pre-specified|Peak Serum Level of Monoclonal Antibody SGN-30|Record the highest serum level of monoclonal antibody SGN-30 achieved.|Up to day 21 of course 6|Data was only available on 10 participants from Arm 1. (No participants from Arm II were evaluable for this endpoint as they did not receive SGN-30 per protocol.)|||mg/ml||Full Range|Median
1272292|NCT00337194|Secondary|Overall Survival (OS) At 1 Year|Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method.|1 year||||percentage of participants||95% Confidence Interval|Median
1272293|NCT00337194|Secondary|Event Free Survival (EFS)|Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Up to 10 years||||months||95% Confidence Interval|Median
1272294|NCT00337194|Primary|Number of Participants With Overall Response (OR)|The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): >= 50% reduction in sum of the product of diameters of indicator lesions.|Up to 10 years||||participants|||Number
1272295|NCT00337181|Primary|Number of Participants Reaching Clinical Long Term Component Endpoints|Evaluate the vaccine effect on clinical long term endpoints: CD4 is for CD4<350 endpoint; ART is for initiation of highly-active antiretroviral therapy (HAART) endpoint; ADI is for AIDS-defining illness endpoint; A combination of multiple endpoints is listed in order of occurrences of the endpoints|66 months|Participants analyzed correlates to responders of endpoints|||Participants|||Count of Participants
1272296|NCT00337168|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle|Eligible patients who started therapy|||Participants with a given type of AE|||Number
1272297|NCT00337168|Secondary|Number of Patients With Very Poor Risk Cytogenetics||On average, 2 weeks before treatment started|Eligible patients with acceptable centrally reviewed cytogenetics|||participants|||Number
1272298|NCT00337168|Secondary|Expression of Nucleoside Transporters|Expression was examined in paraffin-embedded tissue by immunohistochemistry. Intensities were scored on a 0-2+ scale. High expression was a score of 2+.|On average, two weeks before treatment started|Eligible patients who submitted paraffin-embedded tissue|||participants|||Number
1272299|NCT00337168|Primary|Number of Patients With Complete Remission|Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease|Between day 28 and day 35 inclusive|Eligible patients who started therapy|||participants|||Number
1272300|NCT00337129|Secondary|Participants With a Given Type of AE|The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.|Every 3 weeks while on protocol therapy, up to 3 years.|All eligible patients who started protocol treatment are included in analysis of toxicity|||participants|||Number
1272301|NCT00337129|Secondary|Overall Survival|Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.|Only eligible patients were included in the analysis.|||months||95% Confidence Interval|Median
1272302|NCT00337129|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.|Every 6 weeks until progression of disease up to a maximum of 3 years after registration.||||months||95% Confidence Interval|Median
1272303|NCT00337129|Primary|Response Probability (Confirmed Complete and Partial Responses)|Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.|Every 6 weeks until progression of disease up to a maximum of 3 years after registration|Only eligible patients were included in the analysis|||participants|||Number
1272332|NCT00336700|Secondary|Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)|Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).|Up to 60 months||||percentage of participants|||Number
1272333|NCT00336700|Secondary|Estimated 1&2 Year Overall Survival (OS)|Time from from date of first study therapy to to death from any cause.|Up to 60 months||||percentage of participants||95% Confidence Interval|Number
1272304|NCT00337103|Primary|Progression Free Survival (PFS)|PFS was defined as the time (in days) from the date of randomization to the date of the first sign of disease progression based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v 1.1) or date of death, regardless of cause. Disease progression was measured by computed tomography (CT) and magnetic resonance imaging (MRI) performed on lesions targeted at baseline for tumor assessment. Disease progression (as assessed by independent review of the imaging scans) per RECIST v 1.1 was defined as at least a 20% increase in the sum of the diameters of the target lesions (taking as reference the smallest sum on study, including the baseline sum if that is the smallest), and an absolute increase of at least 5 mm. Note that the appearance of one or more new lesions was also considered as PD.|From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date 12 Mar 2012 or up to approximately 6 years|Data was analyzed using Safety Population defined as all subjects who received at least one dose of study treatment.|||Days||Full Range|Median
1272305|NCT00337103|Primary|Overall Survival (OS)|OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant died during the study, the date of death was considered the end date, 2) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 3) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff.|From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years|Data was analyzed using the Intent-to-Treat Population defined as all participants who were randomized.|||Days||Full Range|Median
1272306|NCT00337077|Secondary|Proportion of Patients With Measurable Disease Response|Measurable disease response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Measurable disease response = CR + PR. Only patients with measurable disease at baseline are included in this analysis.|Assessed every 9 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years from study entry|Eligible and treated patients with measurable disease at baseline are included in this analysis.|||Proportion of participants||90% Confidence Interval|Number
1272307|NCT00337077|Primary|Proportion of Patients With PSA Response|PSA response is defined as a PSA decline from baseline value by >=50%, or normalization of PSA (<0.2 ng/ml) confirmed by a second measurement greater than or equal to 4 weeks later.|Assessed every 3 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years|Eligible and treated patients are included in this analysis.|||Proportion of participants||90% Confidence Interval|Number
1272308|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 168|Intent-to-treat (ITT)|||percentage|||Number
1272309|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 84|Intent-to-treat (ITT)|||percentage|||Number
1272310|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 168|Intent-to-treat (ITT)|||percentage|||Number
1272311|NCT00336973|Primary|Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 84|Intent-to-treat (ITT)|||percentage|||Number
1272312|NCT00336895|Primary|Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)|"The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation) The range of the scale for abdominal pain was 3 to 21, reflux 2 to 14, diarrhea 3 to 21, indigestion 4 to 28 and constipation 3 to 21.~Higher values represent more severe discomfort."|12 weeks||||units on a scale||Standard Deviation|Mean
1272313|NCT00336895|Primary|Number of Participants With Cytomegalovirus Infection or Disease||12 weeks||||participants|||Number
1272314|NCT00336895|Primary|Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)|"The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.~The scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort)~The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation)"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
1272315|NCT00336856|Secondary|Overall Survival|time from start of protocol therapy until death from any cause|Up to 30 months||||months||95% Confidence Interval|Median
1272316|NCT00336856|Secondary|Time to Progression|time from start of protocol therapy until objective tumor progression|Up to 30 months||||months||95% Confidence Interval|Median
1272317|NCT00336856|Primary|Response Rate (RR)|Percentage of partial responses (PR) + complete responses (CR).|every 6 - 8 weeks, up to 30 months||||percentage of participants||95% Confidence Interval|Number
1272325|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Constipation Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~Constipation subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
1272326|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Diarrhea Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~The Diarrhea subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
1272327|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Indigestion Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~The Indigestion subscale range is 4 to 28 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
1272328|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Reflux Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~Reflux subscale range is 2 to 14 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
1272329|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~The abdominal Pain subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
1272330|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The total GSRS range of scores is 15 to 105 with higher scores meaning the worst of symptoms."|screening, 2, 6 and 12 weeks|One participant in the myfortic group was ineligible|||units on a scale||Standard Deviation|Mean
1272331|NCT00336700|Secondary|KRAS Mutational Status|KRAS mutation status in resected tumor specimens.|Up to 60 months||||percentage of participants|||Number
1272334|NCT00336700|Primary|2-year Recurrence Free Survival (RFS)||Up to 60 months||||percentage of participants||95% Confidence Interval|Number
1272338|NCT00336583|Primary|Overall Response Rate|The Overall Response Rate was measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response was evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.|up to 24 weeks|25 patients who had completed at least 3 cycles of ESHAOx study treatment were analyzed. 2 patients who did not complete 3 cycles of study treatment were excluded from the response analysis.|||pariticipants|||Number
1272339|NCT00336544|Secondary|Bacteriologic Cures in the Per Protocol Clinically Evaluable Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study|Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.|||Participants|||Number
1272340|NCT00336544|Primary|Clinical Cures in the Per Protocol Clinically Evaluable Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study|The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations|||Participants|||Number
1272341|NCT00336544|Secondary|Bacteriologic Cures in the Intent to Treat Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study|Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.|||Participants|||Number
1272342|NCT00336544|Primary|Clinical Cures in the Intent to Treat Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study|The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.|||Participants|||Number
1272343|NCT00336505|Secondary|Bacteriologic Cures in the Per Protocol Clinically Evaluable Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.|||Participants|||Number
1272344|NCT00336505|Primary|Clinical Cures in the Per Protocol Clinically Evaluable Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study drug|The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations|||Participants|||Number
1272345|NCT00336505|Secondary|Bacteriologic Cures in the Intent to Treat Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.|||Participants|||Number
1272346|NCT00336505|Primary|Clinical Cures in the Intent to Treat Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.|||Participants|||Number
1272776|NCT00331760|Secondary|Grade 2+ Bowel Adverse Events (Diarrhea, Enteritis, Fistula, Ileus; Gastrointestinal (GI), Incontinence; Anal, Necrosis; GI, Obstruction; GI, Perforation; GI, Proctitis and Stricture/Stenosis (Including Anastomotic) as Graded by CTCAE v. 3.0)||From the start of treatment to 90 days.|||||||
1272347|NCT00336492|Secondary|The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54|Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score <10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI.|Week 54|PUCAI remission at Week 54 analysis was based on all participants randomized at Week 8 who were evaluable for PUCAI. Fifteen participants discontinued Infliximab treatment.|||Participants|||Number
1272348|NCT00336492|Primary|The Number of Participants With Clinical Response at Week 8|Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by >=30% and >= 3 points, with a decrease in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient.|Week 8|The primary efficacy endpoint analysis was based on all treated participants.|||Participants|||Number
1272349|NCT00336479|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1272350|NCT00336479|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).|||participants|||Number
1272351|NCT00336479|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from the subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. “Study drug” includes all investigational agents (including placebo, if applicable) administered during the course of the study.|Baseline up to Week 48|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||participants|||Number
1272352|NCT00336479|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|12 weeks after the completion of study drug dosing (up to Week 60)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
1272353|NCT00336479|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
1272354|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had Within >11% Increase in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
1272355|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had Within ±11% Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
1272356|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had a >11% Decrease in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
1272384|NCT00336323|Secondary|Change in Visual Acuity Letter Score From Baseline Over All All Study Visits|Change in visual acuity letter score as measured using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. At baseline and at each follow up visit, best corrected visual acuity was measured at 3 meters by a certified tester using an electronic procedure based on the E-ETDRS method. Letter score best value = 97 and worst value = 0; positive change represents an improvement in letter score.|Baseline to 3,6,9, and 12 weeks||||letters||Inter-Quartile Range|Median
1272357|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had a >11% Increase in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
1272358|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had Within ±11% Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
1272359|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had a >11% Decrease in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
1272360|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had a >11% Increase in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|There were no participants with a change in central subfield thickness from 3 to 6 weeks in this treatment group that had a >11% increase in change of central subfield thickness from baseline to 3 weeks.||||||
1272361|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had Within a ±11% Change in Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks||||participants|||Number
1272362|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had a >11% Decrease in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks||||Participants|||Number
1272363|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had a >11% Increase in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The pooled 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks||||Participants|||Number
1272364|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had Within a ±11% Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The pooled 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks||||participants|||Number
1272365|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had a >11% Decrease in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg Bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Duration of effect of Bevacizumab was based on additional improvement versus maintained improvement versus worsening within 3 to 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in the DRCR.net paper, Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema.Ophthalmology 2007;114:1520-25.|3 to 6 Weeks||||Participants|||Number
1272399|NCT00336024|Secondary|Number of Participants With Chronic Central Hypothyroidism|Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. “Normal” and “Abnormal” are defined at each institution by the laboratory standards where the blood tests are run. Central Hypothyroidism is defined as Free T4 level less than “Institutional” Normal with TSH less than or equal to “Institutional” Normal.|Beginning of treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272366|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Subretinal Fluid Presence at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
1272367|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Clinical Diabetic Macular Edema Characterization at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
1272368|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Retinopathy Severity at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
1272369|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to History of Treatment for Diabetic Macular Edema|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
1272370|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Gender|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
1272371|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
1272372|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Visual Acuity at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
1272373|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Central Subfield Thickness at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
1272374|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Subretinal Fluid Presence at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
1272432|NCT00335764|Primary|Number of High Grade (3 and 4) Related Adverse Events of Each Combination Agent Combined With BAY 43-9006 (Phase I)|CTCAE 3.0|28 days||||Events|||Number
1272433|NCT00335764|Primary|12 Month Survival Rate (Phase II)|number of patients alive at 12 months|12 months|Group 3 did not reach an MTD Hence, did not complete the Phase 2 portion of study, combination treatment too toxic.|||Participants|||Count of Participants
1272375|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Clinical Diabetic Macular Edema Characterization at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
1272376|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Retinopathy Severity at Baseline|Pooled Bevacizumab group includes treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks + laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. Retinopathy severity based on investigator discretion on clinical examination.|baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
1272377|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to History of Treatment for Diabetic Macular Edema at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
1272378|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Gender|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
1272379|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
1272380|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Visual Acuity Letter Score|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
1272381|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Central Subfield Thickness|Pooled Bevacizumab groups include the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
1272382|NCT00336323|Secondary|Distribution of Change in Visual Acuity Over All Study Visits|Visual acuity letter score as measured using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. At baseline and at each follow up visit, best corrected visual acuity was measured at 3 meters by a certified tester using an electronic procedure based on the E-ETDRS method. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant.|Baseline to 3,6,9, and 12 weeks||||participants|||Number
1272383|NCT00336323|Primary|Percentage of Participants With <250 Microns or ≥ 50% Reduction in Retinal Thickening From Baseline Over All Study Visits|Central subfield retinal thickness measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading.|Baseline to 3,6,9, and 12 Weeks|The primary analysis included per protocol and intent to treat analysis. The intent to treat analysis included all randomized eyes. The last observation carried forward method was used to impute missing data. The per-protocol analysis was performed including only patients who receive treatment as per the protocol and complete the 9-week exam.|||percentage of participants|||Number
1272434|NCT00335764|Primary|Plasma Time Curve (AUC) of Group 3 Phase I Sorafenib and Tipifarnib 100mg BID (Level 1)|Group 3: PKs for Dose level 1 Tipifarnib 100mg BID|Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)|Group 3: PKs for Dose level 1 Tipifarnib 100mg BID|||ng*hr/mL||Standard Deviation|Mean
1272385|NCT00336323|Primary|Change in Central Subfield Retinal Thickness From Baseline Over All Study Visits|Change in central subfield retinal thickness from baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading. Negative changes represent a decrease in retinal thickening.|Baseline to 3,6,9, and 12 weeks|The primary analysis included per protocol and intent to treat analysis. The intent to treat analysis included all randomized eyes. The last observation carried forward method was used to impute missing data. The per-protocol analysis was performed including only patients who receive treatment as per the protocol and complete the 9-week exam.|||microns||Inter-Quartile Range|Median
1272386|NCT00336284|Secondary|Patient Initiated Follow-up|Percentage of total patient initiated inqueries that result in ER or office follow-up visits.|12 months|Only participants with at least one follow-up are included in the analyses|||percent of patient initiated follow-ups|||Number
1272387|NCT00336284|Secondary|Early Detection of Cardiac Events|Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).|12 months|Only participants with at least one follow-up are included in the analyses.|||Days||Full Range|Mean
1272388|NCT00336284|Primary|Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.|Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.|12 months|Safety Event Rate includes events occuring within 12 months of enrollment for participants with at least 1 follow-up.|||Percentage of participants|||Number
1272389|NCT00336284|Primary|Home Monitoring Effectiveness|Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.|12 months|Only participants who completed at least one follow-up visit are included in the analyses.|||In-office ICD follow-up per patient year||Full Range|Mean
1272390|NCT00336232|Primary|Plasma Phylloquinone|Plasma phylloquinone in response to phylloquinone depletion and repletion|2 months||||nmol/L||Standard Deviation|Mean
1272391|NCT00336024|Secondary|To Determine Number and Nature of Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort|The number of patients with molecular subtypes of MB, CNS-PNETs/EBTs will be reported along with 95% CI.|From baseline to December 2018||2019-03-31|03/2019||||
1272392|NCT00336024|Secondary|Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).|"Three tools are used to assess intelligence (IQ) depending on age. The range of IQ scores is 40-160 (mean=100, SD=15); range for the Processing Speed Index (PSI)=45-155. Higher scores represent better functioning. (1) Wechsler Preschool and Primary Scale of Intelligence-4th Edition (WPPSI-IV) is used for ages 2.5 to 6 years. Bug Search and Cancellation subtests are summed to calculate PSI. (2) Wechsler Intelligence Scales for Children-5th Edition (WISC-V) is used for ages 6 - 16 years. Symbol Search and Coding subtests are summed to calculate PSI. (3) Wechsler Adult Intelligence Scales-4th Edition (WAIS-IV) is used for ages 16 and older. Symbol Search and Coding subtests are summed to calculate PSI.~The Pediatric Quality of Life Inventory Version 4 (PedsQL) measures health-related quality of life (QOL). Parents complete the measure for children ages 2-17, and patients > 18 complete a self-report version. Total scores range from 0-100, with higher scores representing better QOL."|From baseline to 5.25 years|Of the 77 eligible participants in ACNS0334, only 4 patients completed assessments in ALTE07C1 study. The targeted number of participants to achieve target power and statistically reliable results was not achieved and therefore the data is statistically uninterpretable.|||scores on a scale||Full Range|Median
1272393|NCT00336024|Secondary|Rates of Nutritional Toxicities|Rates of nutritional toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.|In each 21 day cycle (up to 6 cycles)|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272394|NCT00336024|Secondary|Rates of Gastrointestinal Toxicities|Rates of gastrointestinal toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.|In each 21 day cycle (up to 6 cycles)|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272395|NCT00336024|Secondary|Number of Participants With Chronic/Late Hearing Loss and No Chronic/Late Hearing Loss|The number of patients who are reported to have abnormal hearing, graded according to CTCAE 4.0 or not, with onset while on therapy or when off therapy which persisted after off therapy will be reported and will be compared using Fisher exact test.|Beginning of treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272396|NCT00336024|Secondary|Number of Participants With Secondary Malignancies|The number of patients who had secondary malignancy will be reported for this analysis due to small numbers.|Beginning of treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272397|NCT00336024|Secondary|Number of Participants With Chronic Diabetes Insipidus|The number of patients who had “Diabetes Insipidus” and on DDAVP will be reported for this analysis due to small numbers.|Beginning of treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272398|NCT00336024|Secondary|Number of Participants With Chronic Low Somatomedin C|Low Somatomedin C is defined as patients with somatomedin C value less than institutional normal. As numbers are too small, descriptive statistics such as number will be reported for this analysis. Growth hormone function was assessed as per ACNS0334 Endocrine Guidelines. Low Somatomedin C levels are defined at each institution by the laboratory standards where the blood tests are run.|Beginning of treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272400|NCT00336024|Secondary|Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism|Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. “Normal” and “Abnormal” are defined at each institution by the laboratory standards where the blood tests are run. Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism is defined as patients with Free T4 level less than “Institutional” Normal or equal to “Institutional” Normal with TSH level greater than “Institutional” Normal.|Beginning of treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272401|NCT00336024|Secondary|Number of Participants With Acute Hearing Loss and No Acute Hearing Loss|Per protocol, hearing was assessed pretreatment and at regular specified intervals during treatment and off therapy, using DPOAE, audiogram or Brainstem Evoked Auditory. Per CTCAE V4.0 grade 3 Hearing impaired is defined as follows; Pediatric (on a 1,2,3,4, 6 and 8 kHz audiogram): hearing loss sufficient to indicate therapeutic intervention, including hearing aids, threshold shift >20 dB at 3 kHz and above in at least one ear, additional speech-language related services as indicated. Per CTCAE V4.0 grade 4 Hearing impaired is defined as follows; Pediatric Audiologic indication for cochlear implant and additional speech-language related services as indicated.|Beginning of treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
1272402|NCT00336024|Secondary|Percentage of Participants With Any Acute Adverse Events.|Event is defined as the first occurrence of any acute toxicity. Estimates will be obtained using life-table methods. Patients who have progression or recurrence of disease will be censored in this analysis. Difference in incidence for the two treatment regimens will be compared using log-rank test.|Beginning of treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1272403|NCT00336024|Secondary|Patterns of Failure|The patterns of failure for relapse/disease progression will be provided for patients treated with/without methotrexate drug. The two groups will be compared to detect a statistically significant difference using Fisher exact test.|Baseline to up to 5 years|All Eligible Participants who relapsed/disease progressed in the study.|||Participants|||Count of Participants
1272404|NCT00336024|Secondary|Percentage of Participants With Event Free Survival (EFS)|EFS was defined as time from enrollment to the occurrence of first event (disease progression/relapse, secondary malignancy, death from any cause) or date of last contact for patients who are event-free. The percentage of participants with EFS and 90% confidence interval were provided. The difference in incidence for the two treatment regimens were compared using a one-sided log-rank test with a significance level of 0.1.|Baseline to up to 5 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||percentage of participants with EFS||90% Confidence Interval|Number
1272405|NCT00336024|Primary|Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate|At the end of consolidation, the number of evaluable patients treated with intensive chemotherapy with methotrexate who achieved CR or not will be compared to those who achieved CR or not after treated with the same intensive chemotherapy without methotrexate. The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test. Complete Response (CR) requires: CR for target lesions: disappearance of all target lesions, CR for non-target lesions: disappearance of all non-target lesions and no new lesions. No CR is any response not fitting the definition of CR.|From baseline to up to 9 years|Per protocol, only evaluable patients are included.|||Participants|||Count of Participants
1272406|NCT00335972|Primary|Intravenous Morphine Equivalents During Post-anesthesia Care Unit (PACU) After Surgery|intravenous morphine equivalents (mg)|During Post-anesthesia care unit after surgery,an average of 4 hours||||mg||Inter-Quartile Range|Median
1272407|NCT00335972|Primary|Visual Analogue Scale (VAS) Pain Score|Using a ruler, the score is determined by measuring the distance on the 10-cm line between the “no pain” anchor and the patient’s mark, providing a range of scores from 0–10. 0 = no pain and 10 = worst|pain score measured at 15, 30, 45, 60, and 90 minutes after extubation||||cm||Standard Deviation|Mean
1272408|NCT00335972|Primary|Mean Arterial Pressure||mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation||||mmHg||Standard Deviation|Mean
1272409|NCT00335959|Primary|Pathologic Complete Response|Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.|17-19 weeks|Eligible patients who completed pre-operative therapy were assessed for response.|||participants|||Number
1272410|NCT00335959|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.|Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants with a given type of AE|||Number
1272411|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycles 2 and 3|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for patients (n=14) who completed 2 or 3 cycles of TACE and bevacizumab therapy|6 months|14 out of the original 26 study participants completed 2 or 3 cycles of TACE and bevacizumab therapy - adverse events associated with these patients for cycles 2 and 3 assessed.|||adverse events|Adverse events||Number
1272412|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycle 1 Post-TACE|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for 25 who completed the first cycle of TACE and bevacizumab therapy|Cycle 1 post-TACE - 5 weeks|1 out of the initial 26 patients did not complete the first TACE on protocol and was not included in this assessment.|||adverse events|Adverse events||Number
1272413|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycle 1 Pre-TACE|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for all patients (n=26) who received bevacizumab prior to TACE therapy.|Cycle 1 pre-TACE - 2 weeks||||adverse events|Adverse events||Number
1272414|NCT00335829|Secondary|Response Rate - Based on Tumor Enhancement|"Efficacy as assessed by radiographic tumor response utilizing the following tumor enhancement criteria:~Complete Response (CR): 100% tumor necrosis of the target lesion(s) upon completion of any of the 3 cycles of TACE therapy Partial Response (PR): Greater than 50% tumor necrosis of target lesion(s) Progressive Disease (PD): Reappearance or increased tumor enhancement greater than 25% in target lesion(s) Stable Disease (SD): Cases that do not meet CR or PR and did not demonstrate evidence of tumor progression.~The overall response rate (ORR = CR + PR) was 60%. Disease control rate (DCR = CR + PR + SD) was 100%."|6 months||||Participants|||Count of Participants
1272415|NCT00335829|Secondary|Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 3 weeks after TACE, and 4 weeks after completion of final cycle.~Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|6 months||||Participants|||Count of Participants
1272416|NCT00335829|Secondary|Overall Survival (OS)|OS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death.|1 year||||months||95% Confidence Interval|Median
1272417|NCT00335829|Secondary|TTP Rate at 6 Months and 1 Year|Overall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year|6 months and 1 year||||percentage of participants||95% Confidence Interval|Number
1272418|NCT00335829|Secondary|Overall TTP|Overall TTP assessed via Kaplan-Meier methodology.|1 year||||months||95% Confidence Interval|Median
1272419|NCT00335829|Secondary|TTP of Nontargeted Lesions Within the Liver|TTP of nontargeted lesions assessed via Kaplan-Meier methodology.|1 year||||months||95% Confidence Interval|Median
1272420|NCT00335829|Primary|Time to Tumor Progression (TTP) of Targeted Lesions|Time to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment.|6 months and 1 year||||months|||Number
1272421|NCT00335829|Primary|Median Progression-free Survival|This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported.|Time through study completion, an average of 1 year|PFS analysis was not conducted.||||||
1272422|NCT00335777|Primary|Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.|"Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). Pain free is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe)."|2 hours post treatment with study medication|Per protocol population was used in the efficacy analyses. 22 subjects were included, since they treated a migraine early and another migraine late, as defined in the protocol, with study medication.(Cross-over design)|||participants|||Number
1272423|NCT00335777|Secondary|Use of Rescue Therapy for Each Attack Treated Per Subject||number subjects using rescue used between 2 and 24 hrs after study drug|||||||
1272424|NCT00335777|Secondary|Subjects Historical Response to Triptan Therapy and Ergot Therapies||baseline|||||||
1272425|NCT00335777|Secondary|Pain and Associated Symptoms Assessments as Measured at Pre-dose, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose||baseline, 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr. 8 hr, 24 hr|||||||
1272426|NCT00335777|Secondary|Allodynia Assessments as Performed at Pre-dosing, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose Has Been Adminis||baseline, 15 minutes, 30 min., 1 hr., 1.5 hr, 2 hr, 4 hr, 8 hr, 24 hr|||||||
1272427|NCT00335764|Other Pre-specified|Molecular Targeted Combinations Correlative Study Initiative|Determine the relationship between tumor and blood biomarkers and clinical outcome of patients this was more an exploratory correlative and was not completed due to the negative outcome of other parts of the study|28 days|This was more an exploratory correlative and as per the pre-specified protocol, was only to be performed if the outcome of other parts of the study indicated positive results.||||||
1272428|NCT00335764|Other Pre-specified|Exploratory Correlative Laboratory Studies (Phase II)|Examination of tissue markers of signal transduction pathways by immunohistochemical analysis this was an exploratory measure and it was not explore due to the negative results of the rest of the study|28 days|this was more an exploratory correlative and as per the pre-specified protocol, was only to be performed if the outcome of other parts of the study indicated positive results.||||||
1272429|NCT00335764|Primary|Objective Response Rate in Patients With Measurable Disease (Phase II)|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|Up to 5 years||||Participants|||Count of Participants
1272430|NCT00335764|Primary|Progression-free Survival at 6 Months (Phase II)|Patients with a scan at 6 months without progressive disease Progressive disease defined as Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.|6 months|Group 3 did not reach an MTD not complete the Phase 2 portion of study, combination treatment too toxic. End points not followed for group 3 Phase 2|||weeks||95% Confidence Interval|Mean
1272431|NCT00335764|Primary|Number of High Grade (3 and 4) Related Adverse Events of Each Combination Agent Combined With BAY 43-9006 (Phase 2)||1 year||||events|||Number
1272435|NCT00335764|Primary|Plasma Time Curve (AUC) of Group 3 Phase I Sorafenib and Tipifarnib 100mg QD (Level -1)|"Group 3: PKs for Dose level -1 100mg QD~Note that although 9 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference"|Cycle 1 (D1, D15, D28) (0,1,2,4,6,8,12,24hr post drug administration)|Group 3: PKs for Dose level -1 Tipifarnib 100mg QD Sorafenib started day 2|||ng*hr/mL||Standard Deviation|Mean
1272436|NCT00335764|Primary|Pharmacokinetic CpMax Concentration of Group 3 Sorafenib and Tipifarnib (Phase I) 100mg BID|"Group 3: patients were studied for their day 1 Cmax, and day 15 Cmax Tipifanib and Day 15 and Day 28 sorafenib~Group 3: Only PKs for Dose level 1 and -1 were collected."|Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)|"Group 3: patients were studied for their day 1 Cmax, day 15 Cmax. and Day 28 Cmax PKs for 100mg BID Tipifarnib Note that although 10 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference~Level 1 (n=10): Day 1 n=6 (4 samples not evaluable) and D15 n=5 (5 samples not evaluable)"|||ng/mL||Standard Deviation|Mean
1272437|NCT00335764|Primary|Pharmacokinetic Cpmax Group 3 Sorafenib and Tipifarnib (Phase I) 100 mg QD (Level -1)|Group 3: Only PKs for Dose level 1 and -1 were collected.|Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)|Group 3: Only PKs for Dose level 1 and -1 were collected. Note that although 6 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference|||ng/mL||Standard Deviation|Mean
1272438|NCT00335764|Primary|Plasma Time Curve (AUC) of Group 2 Sorafenib and Temsirolimus (Phase I)|"Day 1 = 12 patients (1 sample not evaluable) Day 15 = 5 patients (8 samples not evaluable)~AUC - Area Under Curve~8 samples collected over 24 hours - 28 day PKs"|Cycle 1 (D1, D15, D28) (0,1,2,4,6,8,12,24hr post drug administration)|13 patients temsirolimus 25mg and Sorafenib at either 200mg or 400mg. 1 patient withdrew early hence specimens not analyzed in other cases samples were either missing or not enough to analyze if numbers are not 12|||mcg*hr/mL||Standard Deviation|Mean
1272439|NCT00335764|Primary|Trough Concentration Group 2 Sorafenib and Temsirolimus (Phase I)|Group 2: 12 patients were analyzed for Day 1 (1 patient not evaluable), 5 patients were analyzed for Day 15 (8 patients not evaluable)|15 days|Group 2: 12 patients were analyzed for Day 1, 5 patients were analyzed for Day 15. In both cases samples were either missing or not enough to analyze.|||ng/mL||Standard Deviation|Mean
1272440|NCT00335764|Primary|Pharmacokinetic AUC 0-12 Group 1 Sorafenib and Erlotinib (Phase I)|"8 samples collected over 24 hours on Day 1, day 15 and day 28~16 patients Note that although 16 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference AUC - Area Under Curve"|28Days (D1, D15, D28) (0,1,2,4,6,8,12,24hr post administration) AUC 0-12|8 samples collected over 24 hours on Day 1, day 15 and day 28 AUC 0-12 16 patients treated at 100mg erlotinib,and Sorafenib at either 200 or 400mg Note that although 16 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference|||ug xhr/mL||Standard Deviation|Mean
1272441|NCT00335764|Primary|Pharmacokinetic cMax Group 1 Sorafenib and Erlotinib (Phase I)|"8 samples collected over 24 hours on Day 1, day 15 and day 28~13 total patients treated 100mg Erlotinib and either 200mg or 400mg of Sorafenib"|28days (D1, D15, D28) (0,1,2,4,6,8,12,24hr post administration)|8 samples collected over 24 hours on Day 1, day 15 and day 28 (0,1,2,4,6,8,12hr, & 24hr post administration). Note that although 16 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference|||ng/mL||Standard Deviation|Mean
1272442|NCT00335764|Primary|Pharmacokinetic Max Concentration (Cmax) of Group 2 Sorafenib and Temsirolimus (Phase I)|Group 2: 13 patients received temsirolimus 25mg IV and 7 patients treated with 200mg Sorafenib and 6 patients treated with 400mg Sorafenib|cycle 1 ((Day1, Day15, Day28)|Group 2: total 13 patients were studied for their day 1 Cmax ,day 15 Cmax and day 28 Cmax Note that although 13 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference|||ng/mL||Standard Deviation|Mean
1272443|NCT00335764|Primary|Maximum Tolerated Dose (MTD) of the Each Combination Agent Combined With a Fixed Dose of BAY 43-9006 Determined by Dose-limiting Toxicities (DLT) (Phase I)|DLT defined as: any grade 4 hematologic toxicity; grade 3 thrombocytopenia > 7 days, any grade 3/4 non-hematologic toxicity (despite maximal medical therapy), any intolerable grade 2 non-hematological, ro grade 3 hematological toxicity requiring deduction during first 28 days of treatment, any toxicity resulting in delay of >1week during first 28 days of treatment|28 days|3+3 design due to excessive toxicities of Group 3 no DLT was defined for Group 3|||mg|||Number
1272444|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI)|Proportion of patients who had ciliary body infiltration at enrollment.|At Enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with CBI||95% Confidence Interval|Number
1272445|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Iris Infiltration (II)|Proportion of patients who had iris infiltration at enrollment.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with II||95% Confidence Interval|Number
1272446|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS)|Proportion of patients who had anterior chamber seeding at enrollment.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with ACS||95% Confidence Interval|Number
1272447|NCT00335738|Secondary|Pathological Features Present at Diagnosis - Scleral Invasion (SI)|Proportion of patients that had scleral invasion at enrollment.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with SI||95% Confidence Interval|Number
1272448|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding|Proportion of patients with tumor involving the optic nerve posterior to the lamina cribrosa as an independent.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with LC||95% Confidence Interval|Number
1272449|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)|Proportion of patients who had posterior uveal invasion at enrollment.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with PVI||95% Confidence Interval|Number
1272450|NCT00335738|Secondary|Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity.|During planned six cycles of chemotherapy|Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332.|||participants|||Number
1272451|NCT00335738|Primary|Overall Survival (OS)|OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.|At 2 Years|Only eligible patients are considered for this outcome measure. This is calculated as the total number of patients enrolled in each group with the number ineligible in each group subtracted as reported on the participant flow template.|||Estimated Probability||95% Confidence Interval|Number
1272452|NCT00335738|Primary|Event-free Survival (EFS)|EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.|At 2 years|Only eligible patients are considered in the characterization of EFS at 2 years.|||Estimated Probability||95% Confidence Interval|Number
1272453|NCT00335725|Secondary|Clinical Pregnancy Rate|clinical pregnancy rate defined as the presence of gestation sac and heart beat.|6 weeks after treatment start|patients who started the FSH treatment|||percentage of treated patients|||Number
1272454|NCT00335725|Primary|Total Number of Oocytes Retrieved|Total number of oocytes retrieved|10 days after stimulation start|patients who started the stimulation with FSH|||oocytes||Standard Deviation|Mean
1272455|NCT00335556|Secondary|Frequency of TP53 Mutations||At baseline|The analysis was supplanted by an analysis done as part of the TARGET initiative on NWTS-5 sample as a result no TP53 data was collected on AREN0321.||||||
1272456|NCT00335556|Secondary|Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization||At baseline|Eligible patients with reported INI1 mutation data.|||Count participants|||Number
1272457|NCT00335556|Primary|Toxicity Rate|Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.|Up to 4 years|Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.|||Percentage of patients||95% Confidence Interval|Number
1272458|NCT00335556|Primary|Event Free Survival Probability|Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).|4 years|Eligible patients with Stage I focal and diffuse anaplastic Wilms tumor.|||Percent Probability 4 Year EFS||95% Confidence Interval|Number
1272459|NCT00335556|Primary|Response Rate|Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non‐index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.|Up to 2 months||||Percentage of participants||95% Confidence Interval|Number
1272460|NCT00335556|Primary|Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors|The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).|4 years|Eligible patients with Stage I-IV rhabdoid tumor.|||Percentage of 4-year OS||95% Confidence Interval|Number
1272461|NCT00335556|Primary|Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)|Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS‐5 (NCT00002610).|4 years|Eligible patients with Stage II-IV DAWT.|||Percentage of 4-year OS||95% Confidence Interval|Number
1272462|NCT00335517|Primary|Number of Patients Enrolled and Recieving Injection||0-48 hours postoperatively||||participants|||Number
1272463|NCT00335504|Secondary|Adverse Events.|Defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with participation in a study, whether or not related to that participation. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 3.0. Number of adverse events per grade level.|Up to 30 days after completion of study treatment||||adverse events|||Number
1272464|NCT00335504|Secondary|Effects on Apoptosis (Caspase-3 Expression).|Tissue is examined by immunohistochemistry for cleaved caspase-3. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.|Up to 6 months|Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.|||Percent change of caspase-3||Standard Deviation|Mean
1272465|NCT00335504|Secondary|Effects on Proliferation (Ki67 Expression).|Tissue is examined by immunohistochemistry for Ki67. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.|Up to 6 months|Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.|||Percent change||Standard Deviation|Mean
1272479|NCT00335283|Secondary|Rhinosinusitis Outcome Measure(RSOM-31)|RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report.|Baseline, 8 weeks, and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.|||Scores on a Scale||Inter-Quartile Range|Median
1272466|NCT00335504|Primary|Percent Change in Number of Rectal Aberrant Cryptic Foci (ACF) as Measured by Magnification Chromoendoscopy|At the Pre-Intervention Evaluation, rectal ACF will be classified with respect to ACF number, crypt number, crypt size, tissue plane, staining intensity, and (optional) lumen shape for each subject. At the Post- Intervention Evaluation, these same parameters will be recorded and incident vs prevalent rectal ACF status will also be recorded. Compare each non-placebo arms versus the placebo arm to screen the three active study agents for possible phase III testing.|6 months|The population used for the analysis is patients having at least 5 rectal ACF and completing both the pre- and post-intervention MCE assessments and using intention to treat principles.|||percent change in number of ACF||Standard Deviation|Mean
1272467|NCT00335478|Primary|Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.|"If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued.~Complete Response: Resolution of fever and clinical signs/symptoms of infection.~Partial Response: Resolution of fever without resolution of clinical signs of infection."|Within 72 hours of starting daptomycin||||participants|||Number
1272468|NCT00335452|Post-Hoc|Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison|This includes definite stent thrombosis (confirmed by angiography or evidence of recent thrombus determined at autopsy or by examination of tissue retrieved following thrombectomy) and probable stent thrombosis (unexplained death having occurred after intracoronary stenting or, MI related to acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any obvious cause) after validation by the EAC.|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.|||participants|||Number
1272469|NCT00335452|Secondary|Occurrence of Major Bleeding - ASA Dose Level Comparison||30 days|The analysis is on the treated patient population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.|||participants|||Number
1272470|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup||30 days|The intent-to-treat (ITT) analysis is done on the randomized patients who underwent PCI during the study.|||participants|||Number
1272471|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level||30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.|||participants|||Number
1272472|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison||30 days|The analysis is on the the ASA treated population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.|||participants|||Number
1272473|NCT00335452|Secondary|Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison|Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.|||participants|||Number
1272474|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison|"The primary endpoint is the first occurrence of any of the following events:~Cardiovascular death (any death with a clear cardiovascular or unknown cause),~Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal)~Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal)~reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC)."|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.|||participants|||Number
1272475|NCT00335322|Secondary|Compare the Safety of Three Strategic Regimens of Initial ART Containing a Fixed Dose Formulation of Tenofovir and Emtricitabine, With Either Efavirenz or Ritonavir Boosted Atazanavir or Zidovudine Plus Abacavir.||144 weeks|||||||
1272476|NCT00335322|Primary|Time-weighted Mean Change From Baseline Plasma HIV-RNA.||48 weeks|Modified ITT; all randomised pts who started drug|||log copies/mL||95% Confidence Interval|Mean
1272477|NCT00335283|Secondary|Quality of Life Questionnaire (QOLRAD)|The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life.|Baseline, 8 weeks and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.|||Scores on a Scale||Inter-Quartile Range|Median
1272478|NCT00335283|Secondary|Sino Nasal Outcome Test (SNOT-20)|SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity.|Baseline, 8 weeks and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.|||Scores on a Scale||Inter-Quartile Range|Median
1273195|NCT00329238|Secondary|Symptomatic Pulmonary Embolism (PE) at 18 Months|Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.|18 months|FAS|||Participants|||Number
1272480|NCT00335283|Primary|Post Nasal Drainage Symptom Response|The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.|8 and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.|||Scores on a Scale||Inter-Quartile Range|Median
1272481|NCT00335257|Primary|Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs|Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.|Within 60 months|Study participants that were not excluded due to protocol violation|||participants|||Number
1272482|NCT00335257|Primary|Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs|Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.|Within 60 months|Study participants that were not excluded due to protocol violation|||participants|||Number
1272483|NCT00335153|Primary|Number of Participants Taking at Least 1 Concomitant Medication During the Study|Concomitant medications include those started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.|Screening up to Day 378|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
1272484|NCT00335153|Primary|Number of Participants With Confirmed Cases of Melanoma|A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination or end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.|Screening up to Day 378|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
1272485|NCT00335153|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272486|NCT00335153|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state'.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272487|NCT00335153|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272488|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272510|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with given assessment.|||participants|||Number
1272489|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272490|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272491|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272492|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272493|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272494|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272552|NCT00334282|Secondary|Duration of Response|Duration of response is defined as the time from first observation of response until progression of disease or death.|Time from response until progression (up to 2 years)|ITT Population. Only results for pazopanib are given because there were not enough placebo responders.|||weeks||95% Confidence Interval|Median
1273641|NCT00325819|Secondary|Fever >=39C Within 32 Hours of Vaccination.|Fever, defined as rectal temperature >=39C within 32 hours of vaccination.|Fever within 32 hours following vaccination|Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group.|||percentage of participants|||Number
1272495|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272496|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272497|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272498|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272499|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272500|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272501|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1272502|NCT00335153|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
1275128|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|8 weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
1272503|NCT00335153|Secondary|"Change From Baseline in Average Daily On Time Without Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||hours||Standard Deviation|Mean
1272504|NCT00335153|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||hours||Standard Deviation|Mean
1272505|NCT00335153|Secondary|"Change From Baseline in Average Daily Off Time at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||hours||Standard Deviation|Mean
1272506|NCT00335153|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint|"The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions regarding issues with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst On time (dyskinesia [involuntary muscle movement])."|Baseline, Endpoint (last Post-PEG Long-Term Period visit up to Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment at timepoint.|||units on a scale||Standard Deviation|Mean
1272507|NCT00335153|Primary|Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period|The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.|Baseline, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with an assessment at timepoint.|||participants|||Number
1272508|NCT00335153|Primary|Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.|During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded) who had an assessment.|||participants|||Number
1272509|NCT00335153|Primary|Number of Participants With Sleep Attacks at Baseline|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.|Baseline|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
1273196|NCT00329238|Secondary|Symptomatic Pulmonary Embolism (PE) at 36 Months|Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.|36 months|FAS|||Participants|||Number
1272511|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.|up to 56 weeks|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.|||participants|||Number
1272512|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include aspartate aminotransferase (AST), upper limit of normal (ULN), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), female (f), and male (m).|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.|||participants|||Number
1272513|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Potentially clinically significant values for red blood cells (RBCs), hemoglobin, and hematocrit are specified for females (f) and males (m) separately in the category rows.|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.|||participants|||Number
1272514|NCT00335153|Primary|Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy – With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods|Complications of the infusion device were collected during the PEG-J Surgery and Post-PEG Long-Term Treatment periods. Pump, PEG-J, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and post-procedural hemorrhage.|PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
1272515|NCT00335153|Primary|Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period|Complications of the infusion device were collected during the NJ Test period. Pump, intestinal tube, NJ tube, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and post-procedural hemorrhage.|NJ Test Period (from 2 to 14 days)|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
1272516|NCT00335153|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.|Screening through Day 378 + 30 days|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
1272517|NCT00335140|Primary|Complete Response Rate - Locally Reviewed|"Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites.~Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks."|For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).|Eligible, treated patients|||percentage of participants||95% Confidence Interval|Number
1272518|NCT00334958|Secondary|Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase|RRATIO= 100*(T-B)/(T+B) where T= total seizure frequency per 28 days during the Maintenance Phase, and B=total seizure frequency per 28 days during the Baseline Phase|Baseline, Days 13 to 96|ITT population|||RRATIO||Standard Deviation|Mean
1272519|NCT00334958|Secondary|Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase|Total partial seizure frequencies per 28 days during the double-blind Maintenance and Baseline Phases were transformed using logarithms to the base 10 (log10), because it was expected from previous studies that the results would not be normally distributed.|Days 13 to 96|ITT population|||Seizures per 28-days (log-transformed)||Standard Deviation|Mean
1272520|NCT00334958|Secondary|Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase|There are 2 major categories of seizures in epilepsy: generalized and partial (focal) seizures. The most frequent type is partial onset seizures. For inclusion in this study, participants needed to have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy Classification of Epileptic Seizures. Seizure data was collected via patient diary, which was used to record daily seizure count and type.|Baseline, Days 13 to 96|ITT population|||Percentage of Participants|||Number
1272521|NCT00334958|Primary|Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase|There are 2 major categories of seizures in epilepsy: generalized and partial (focal) seizures. The most frequent type is partial onset seizures. For inclusion in this study, participants needed to have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy Classification of Epileptic Seizures. Seizure data was collected via patient diary, which was used to record daily seizure count and type.|Baseline, Days 13 to 96|Intent-to-treat (ITT) population: All randomized subjects who had baseline Patient Seizure Diary data and had at least completed the titration period|||Percentage change||Full Range|Median
1272522|NCT00334893|Secondary|Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer|Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events.|From the time of their first treatment with eribulin mesylate|Data were not collected||||||
1272523|NCT00334893|Primary|Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to a total of a year||||participants|||Number
1272524|NCT00334815|Secondary|Response Rate (Confirmed or Unconfirmed Partial Response)|Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.|Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration|Only patients with measurable disease at baseline were included in the analysis of response. Among 15 patients on the Low Risk stratum, 14 had measureable disease at baseline. Among 11 patients on the High Risk stratum, 10 had measureable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
1272525|NCT00334815|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every week, up to 4 years||||Months||95% Confidence Interval|Median
1272526|NCT00334815|Secondary|Progression-free Survival|From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.||||Months||95% Confidence Interval|Median
1272527|NCT00334815|Primary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to one year|All eligible patients, both low-risk and high-risk strata combined, who received protocol therapy.|||Participants|||Number
1272528|NCT00334802|Secondary|Pharmacokinetics - Half Life (t½)|Apparent elimination half-life.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.|||hours||Full Range|Geometric Mean
1272529|NCT00334802|Secondary|Pharmacokinetics - Area Under the Concentration Curve (AUC)|Area under the concentration curve from time zero to infinity.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.|||nanograms*hour per milliliter (ng*hr/mL)||Full Range|Geometric Mean
1272530|NCT00334802|Secondary|Pharmacokinetics - Maximum Plasma Concentration (Cmax)|Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.|||nanograms per milliliter (ng/mL)||Full Range|Geometric Mean
1272531|NCT00334802|Secondary|Number of Participants Alive at One Year (1-Year Survival)||baseline to date of death from any cause, evaluated at 1 year||||participants|||Number
1272532|NCT00334802|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|baseline to measured progressive disease||||days||Full Range|Median
1272533|NCT00334802|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease||||months||Full Range|Median
1272534|NCT00334802|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Responders are patients with complete response or partial response."|baseline to measured progressive disease||||participants|||Number
1272535|NCT00334633|Secondary|Recurrence of BV||baseline to 4 weeks||||Participants|||Count of Participants
1272536|NCT00334633|Primary|Cure of Bacterial Vaginosis|resolution of Amsel criteria for bacterial vaginosis|one month|ITT|||participants|||Number
1272537|NCT00334542|Primary|Change in a Panel of Biomarkers (Contralateral Breast Density) From Baseline||Baseline and week 24|Paired baseline and post-simvastatin treatment mammograms for evaluation of breast density were available for 43 participants.|||percentage of change||95% Confidence Interval|Median
1272538|NCT00334542|Secondary|Prevalence of Akt and p-Akt Activation by Contralateral Core Breast Biopsies||Baseline and week 24|||||||
1272539|NCT00334542|Secondary|Prevalence of Breast Gene (Estrogen Receptor [ER]-α and ER-β, Cyclin D2, RAR-β, Twist, RASSF1A, and HIN-1) Hypermethylation||Baseline and week 24|||||||
1272540|NCT00334542|Primary|Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline||Baseline and week 24|Paired baseline and post-simvastatin treatment fasting lipid samples were available for 47 participants, including 45 women who completed the study and from two who discontinued the drug prior to the completion of the 24–28 weeks of drug, and are integrated in the intention-to-treat analyses|||mg/dl||95% Confidence Interval|Median
1272541|NCT00334295|Secondary|Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)|Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).|ICF (Baseline) up to 12 months (12 visits)|FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.|||units on a scale||95% Confidence Interval|Mean
1272542|NCT00334295|Secondary|Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities|number of adverse events|ICF to Last Patient Out (LPO)||||adverse events|||Number
1272543|NCT00334295|Secondary|Determination (for ITT Set): Median Survival|median overall survival (OS)|ICF to the date of death||||months||95% Confidence Interval|Median
1272544|NCT00334295|Secondary|Time to Progression of Disease (TTP-Time To Progression, for ITT Set)|median TTP|ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)||||months||95% Confidence Interval|Median
1272545|NCT00334295|Primary|Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant|Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.|up to 1 year||||participants|||Number
1272546|NCT00334282|Secondary|Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants|Baseline plasma samples were obtained from participants and were tested for the indicated cytokine and angiogenesis factors. Protein levels were determined using the Searchlight multiplex system based on chemiluminescence.|Baseline|Subgroup of enrolled participants who agreed to have plasma samples collected for biomarker analyses.|||picograms per milliliter||Standard Deviation|Mean
1272547|NCT00334282|Secondary|Plasma Pazopanib Concentrations Before Dosing and at 2, 4, and 8 Hours After Dosing on Day 1 and Week 3|The concentration of pazopanib in the plasma was measured.|Day 1 and Week 3|Subgroup of enrolled participants who agreed to have blood samples collected for analysis of pazopanib in plasma. Data were missing or not collected at Week 3 for 8 participants for whom data were available on Day 1. No samples were collected at Week 3 from 2 participants.|||nanograms per milliliter||Full Range|Median
1272548|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48|The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant’s self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.|||points on a scale||Standard Deviation|Mean
1272549|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48|The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (<0).|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.|||points on a scale||Standard Deviation|Mean
1272550|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 [very poor quality of life] to 7 [excellent quality of life]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.|||points on a scale||Standard Deviation|Mean
1272551|NCT00334282|Secondary|Time to Response as Assessed by an Independent Review Committee (IRC) and the Investigator|Time to response is defined as the time from randomization until the first documented evidence of complete response (all detectable tumor has disappeared) or partial response (a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum) (whichever status was recorded first).|Randomization until CR or PR (assessed for up to 2 years)|ITT Population. Only participants with a complete or partial response were analyzed. Only results for pazopanib are given because there were not enough placebo responders. The different number of participants analyzed is due to differences in clinical judgement, measurement, and the selection of target lesions.|||weeks||95% Confidence Interval|Median
1273197|NCT00329238|Secondary|DVT at 18 Months|Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.|18 months|FAS|||Participants|||Number
1272553|NCT00334282|Secondary|Participants With Complete Response, Partial Response, or 6 Months of Stable Disease|This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a >=20% increase in target lesions. IRC, independent review committee.|Baseline until 6 months post-Baseline or progressive disease|ITT Population|||participants|||Number
1272554|NCT00334282|Secondary|Overall Response|Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.|Baseline until either response or progression (up to 2 years)|ITT Population|||participants|||Number
1272555|NCT00334282|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death. The length of this interval was estimated as the date of death minus the date of randomization plus 1 day. Participants who were still alive at the time of analysis were censored.|Randomization until death (up to 2 years)|ITT Population|||months||95% Confidence Interval|Median
1272556|NCT00334282|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.|Randomization until progression (up to 2 years)|Intent-to-Treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
1272557|NCT00334204|Primary|Need for Blood Transfusion||12||||participants requiring PRBC Transfusion|||Number
1272558|NCT00334204|Primary|Hemoglobin/Hematocrit After Biopsy||12 hours||||participants with hematuria|||Number
1272559|NCT00334204|Primary|Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy||12 hours||||participants with hematoma|||Number
1272560|NCT00334113|Primary|7-Day Physical Activity Recall (PAR)|A self-report measure of minutes of physical activity over the previous 7 days.|six months|Participants analyzed varies from completed participants since the completed number comes from those who stayed in the study through the 12 months (6 months post intervention). In TAU, the number who completed exceeds the number analyzed since 1 participant did not show for the 6 month assessment but did show for the 12 month follow up assessment.|||minutes per week||Standard Deviation|Mean
1272561|NCT00334074|Secondary|Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine|Patients will be monitored clinically and diagnostically using measures including blood test, bone marrow aspiration and MUGA. Toxicity assessment every week using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be performed.|Up to five months (includes follow up period of 30 days) from the day patient received their first dose of study drug|Intention To Treat|||participants; with adverse events|||Number
1272562|NCT00334074|Primary|Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity|"Based on International working group for diagnosis, standardization of response criteria, and treatment outcomes for reporting standards for therapeutic trials in Acute myeloid Leukemia:~Complete Response (CR) was defined as normalization of marrow blasts (< 5%), recovery of normal heamtopoiesis (absolute neutrophil count >1 X 10^9/l, platelet count ≥100 X10^9/l, and absence of peripheral blood blasts, independent of transfusions and growth factor support.~Partial response was defined as blood count recovery as for complete response with the exception of leukemic marrow blasts in the range of 6%-25% or a ≥50% decrease in bone marrow blasts.~Treatment failure was defined as a <25% change in marrow blasts within 30 days of starting therapy"|Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study.|Intent to Treat analysis; per eligible participants enrolled in the study.|||participants|||Number
1272563|NCT00334061|Secondary|Percentage of Participants With Symptomatic Hemorrhage|All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.|24-Hour Post-Procedure||||Percentage of Participants|||Number
1272564|NCT00334061|Secondary|Percentage of Participants With All Cause Mortality||90-Days Post-Treatment||||Percentage of Participants|||Number
1272565|NCT00334061|Secondary|Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment|The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.|90-Day||||Percentage of Participants|||Number
1272566|NCT00334061|Secondary|Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment|"NIHSS is a 42 point scale to describe the neurological status of the patients:~0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death."|Discharge or 30-Days Post-Procedure||||Percentage of Participants|||Number
1272567|NCT00334061|Primary|Percentage of Participants With Device-related and Procedure-related Serious Adverse Events||6-Month Post-Procedure|All adverse events were summarized by showing the number and percent of patients who reported the event. Events were also reported by relationship to the procedure or device. Causality of adverse events was adjudicated by a Clinical Events Committee. The denominator for the analyses was all enrolled patients.|||Percentage of Participants|||Number
1272568|NCT00334061|Primary|Percentage of Participants With Revascularization of the Occluded Target Vessel|"Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System.~TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow."|6-Month Post-Procedure|Intention to Treat|||Percentage of Participants|||Number
1272569|NCT00333983|Primary|Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment|"The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002).~Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.~The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome."|Baseline to Final Training (6 weeks)|The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation.|||units on a scale||Standard Deviation|Mean
1272570|NCT00333970|Primary|Cognitive Performance|Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).|baseline and 2 months|individuals who were randomized and completed 2 month assessments|||units on a scale||Standard Error|Mean
1272571|NCT00333879|Secondary|Accuracy in Selecting Appropriate Time to Cross Street|"Subject is able to state when it is safe to cross the street based on traffic on the street beside him accelerating into motion after traffic on the street in front of him coming to a stop. Subject must state is it safe to cross within 5 seconds of the cars on the street beside him accelerating into motion.~The system under test will be considered efficacious if the subject is correct at least 4 out of 5 times. This counts as being efficacious for that one subject."|4 trials over 30 minutes after 30 minutes of training||||participants|||Number
1272572|NCT00333879|Primary|Accuracy in Judging Direction of Traffic at Traffic Intersection|"Standing at an intersection subject indicates when traffic is moving left to right and right to left in front of him, versus traffic moving to and away on the street parallel to his path. Subject can respond in only two ways: 1) traffic is moving on the street in front of me, or 2) traffic is moving on the street beside me.~Each trial lasts 5 minutes with a 2 minute and 30 second break between trials. Traffic stops and starts 5 times over the 5 minutes, each time moving in one of two randomly selected directions: 1) left and right in front of the subject, or 2) forward and back along the street beside the subject.~The participant must correctly state the direction of traffic at least 4 out of five times for the equipment under test to be counted as efficacious for presenting accurate 3D sound information to the participant."|4 trials over 30 minutes after 30 minutes of training|Initial pilot study design called for 16 subjects to provide data of significance based on a power analysis. Study terminated at 4 subjects when none of the subjects could identify the location of traffic vehicles when using the intervention across multiple (4) trials.|||participants|||Number
1272573|NCT00333866|Secondary|Total Daily Acetaminophen Dose|Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).|Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||mg/day||Standard Error|Least Squares Mean
1272574|NCT00333866|Secondary|Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14|Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||mm||Standard Error|Least Squares Mean
1272575|NCT00333866|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
1272576|NCT00333866|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14|MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
1272577|NCT00333866|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
1272578|NCT00333866|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14|FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
1272579|NCT00333866|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14|FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n’=participants evaluable for specified category for each arm group, respectively.|||Units on a scale||Standard Error|Least Squares Mean
1272580|NCT00333866|Secondary|Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n’=participants evaluable for specified category for each arm group.|||Units on a scale||Standard Error|Least Squares Mean
1272581|NCT00333866|Secondary|Percentage of Participants With Optimal Sleep Assessed Using MOS-SS|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Percentage of participants|||Number
1272582|NCT00333866|Secondary|Change From Baseline in Weekly Mean Sleep Quality Score|Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' participants evaluable at given time point for each group, respectively.|||Units on a scale||Standard Error|Least Squares Mean
1272583|NCT00333866|Secondary|Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)|Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
1272584|NCT00333866|Primary|Patient Global Impression of Change (PGIC)|Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1272585|NCT00333866|Primary|Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)|Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.|Baseline, Week 14|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using last observation carried forward (LOCF) method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
1272586|NCT00333840|Secondary|Percentage of Participants With Major Molecular Response (Second-line Treatment)|Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. No participants in the imatinib to IFN-a + Ara-C arm were available for testing.|||Percentage of participants|||Number
1272587|NCT00333840|Secondary|Percentage of Participants With Major Molecular Response (First-line Treatment)|Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1272588|NCT00333840|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment)|A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant|144 months|Safety Population included all randomized participants who received study drug.|||Participants|||Number
1272589|NCT00333840|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment)|A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant|144 months|Safety Population included all randomized participants who received study drug.|||Participants|||Number
1272590|NCT00333840|Secondary|Percentage of Participants With Best Cytogenetic Response (Second-line Treatment)|"Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.~Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and ≤ 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated."|144 months|Intent-to-treat participants included all randomized participants.|||Percentage of participants|||Number
1272591|NCT00333840|Secondary|Percentage of Participants With Best Cytogenetic Response (First-line Treatment)|"Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.~Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and ≤ 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated."|144 months|Intent-to-treat participants included all randomized participants.|||Percentage of participants|||Number
1272592|NCT00333840|Secondary|Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants)|Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval|||Percentage of participants|||Number
1272593|NCT00333840|Secondary|Percentage of Participants With Event Free Survival Events (All Randomized Participants)|"Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:~progression to Accelerated Phase (AP) or Blast Crisis (BC)~loss of Complete Hematological Response (CHR)~loss of Major Cytogenic Response (MCyR) confirmed~loss of Major Cytogenic Response (MCyR) unconfirmed~increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)~death (due to any cause when reported as primary reason for discontinuation of treatment).~The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment."|144 months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1272594|NCT00333840|Secondary|Kaplan Meier Estimates of Event Free Survival (All Randomized Participants)|"Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:~progression to Accelerated Phase (AP) or Blast Crisis (BC)~loss of Complete Hematological Response (CHR)~loss of Major Cytogenetic Response (MCyR) confirmed~loss of Major Cytogenetic Response (MCyR) unconfirmed~increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)~death (due to any cause when reported as primary reason for discontinuation of treatment).~Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment."|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval|||Percentage of participants|||Number
1272698|NCT00332696|Secondary|Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14|The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.|Day 1, Day 7 and Day 14|"Intent-to-treat population consisted of all randomized participants who received study drug. n in each of the categories is the number of participants with data at the given time point."|||Vomiting episodes||Standard Deviation|Mean
1272595|NCT00333840|Primary|Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)|Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval|||Percentage of participants|||Number
1272596|NCT00333814|Other Pre-specified|Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score|Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality).|Week 8|Intent to Treat|||Percentage of Patients|||Number
1272597|NCT00333814|Other Pre-specified|Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)|Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.|Week 8|Intent to Treat|||Percentage of Patients|||Number
1272598|NCT00333814|Primary|Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero|Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).|Week 8|Intent to Treat|||Percentage of Patients|||Number
1272599|NCT00333801|Secondary|Employment Outcomes (Total Gross Income From All Sources|total gross income from all sources of work including noncompetitive and competitive jobs|one year|All randomized participants (intent-to-treat)|||US dollars||Standard Deviation|Mean
1272600|NCT00333801|Secondary|Employment Outcomes (Gross Income Competitive)|total gross income (US dollars) from all competitive wages, salary, commissions|one year|All randomized participants (intent-to-treat)|||US dollars||Standard Deviation|Mean
1272601|NCT00333801|Secondary|Employment Outcomes (Hours Competitively Employed)|hours employed in a competitive (not set-aside) job|one year|All randomized participants (intent-to-treat)|||hours||Standard Deviation|Mean
1272602|NCT00333801|Secondary|Employment Outcomes (Days Competitively Employed|Number of days employed in a competitive job (not set-aside job)|one year|All randomized participants (intent-to-treat)|||days||Standard Deviation|Mean
1272603|NCT00333801|Secondary|Employment Outcomes (Weeks Competitively Employed)|Number of weeks employed for any time in a competitive job (not set-aside job)|one year|All randomized participants (intent-to-treat)|||weeks||Standard Deviation|Mean
1272604|NCT00333801|Secondary|PTSD, Depression, Disability Outcomes|Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score – lowest possible raw score) / (possible raw score range)] x 100.|one-year|All randomized participants (intent-to-treat)|||units on a scale||Standard Deviation|Mean
1272605|NCT00333801|Primary|Obtain Competitive Employment|The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment.|1 calendar year|All randomized participants were included in the analysis (intent-to-treat)|||participants|||Number
1272606|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
1272607|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
1272608|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
1272609|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
1272610|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
1272611|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
1272612|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272613|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272614|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272615|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272616|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period|"Follow-up period starts the day after the last injection up to 84 days after last injection.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272617|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272618|NCT00333788|Secondary|Length of Hospital Stays During the Overall Period|Overall period corresponds to both treatment and follow-up periods in C87046.|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||days||Standard Deviation|Mean
1272619|NCT00333788|Secondary|Length of Hospital Stays During the Follow-Up Period|Follow-up period starts the day after the last injection up to 84 days after last injection.|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||days||Standard Deviation|Mean
1272620|NCT00333788|Secondary|Length of Hospital Stays During the Treatment Period|The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||days||Standard Deviation|Mean
1272621|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1273198|NCT00329238|Secondary|Deep Vein Thrombosis (DVT) at 36 Months|Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.|36 months|FAS|||Participants|||Number
1272622|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the Follow-Up Period|"Follow-up period starts the day after the last injection up to 84 days after last injection.~Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272623|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272624|NCT00333788|Secondary|Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study|"Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI)~Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed)."|Maximum 154 weeks|Of the 233 subjects in the study 153 are in the Modified Intent to Treat (MITT) population and are responders at Baseline of this study and are in this analysis. The MITT population includes subjects that are in the ITT population that were correctly randomized at Week 6 of study C87042 (NCT00308581).|||days||Full Range|Median
1272625|NCT00333788|Secondary|Change From Baseline of Study C87042 (NCT00308581) in Crohn’s Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 215 are in the Intent to Treat (ITT) population with Crohn's Disease Activity Index (CDAI) scores at Baseline and Last/Withdrawal visits and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||score on a scale||Standard Deviation|Mean
1272626|NCT00333788|Secondary|Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|"Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points~CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects in remission at Last visit."|Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272627|NCT00333788|Secondary|Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|"Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn’s Disease Activity Index (CDAI).~CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects achieving clinical response at Last visit."|Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272628|NCT00333788|Secondary|Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).|"Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).~Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits.~A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects maintaining response at Last visit."|Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 166 are in the Intent to Treat (ITT) population and were in clinical response at Baseline of this study, and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272629|NCT00333788|Primary|Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)|"Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection.~Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
1272630|NCT00333775|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.|||Months||95% Confidence Interval|Median
1282164|NCT00247273|Secondary|Percent Change From Baseline in Serum CTX at Month 24, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 24|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
1272631|NCT00333775|Secondary|Time to Treatment Failure|Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.|Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.|||months||95% Confidence Interval|Median
1272632|NCT00333775|Secondary|Duration of Response|Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.|Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline who had a complete response or a partial response were included in the analysis.|||Months||95% Confidence Interval|Median
1272633|NCT00333775|Secondary|Percentage of Participants With a Complete Response or a Partial Response|Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1272634|NCT00333775|Primary|Progression-free Survival|Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.|||Months||95% Confidence Interval|Median
1272635|NCT00333762|Primary|Time to Complete Trial Wheelchair Course|Time to complete the course was recorded. The indoor course was set up in the research laboratory to include a straight path and 90 degree turns that included obstacles such as a cardboard box, a large orange cone, and a desk chair. The location of these obstacles were randomly placed in order to test whether or not the SPAM or SWCS was able to detect objects.|Two years|No data was collected.||||||
1272636|NCT00333710|Primary|Hepatitis C Virus Knowledge Questionnaire|This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge|pre-treatment, post-treatment||||units on a scale||Standard Deviation|Mean
1272637|NCT00333619|Primary|Sleep Efficiency|Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.|3-month follow-up||||percentage of time asleep while in bed||Standard Deviation|Mean
1272638|NCT00333619|Primary|Pittsburgh Sleep Quality Index|The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 – 21; score > 8 indicates poor sleep quality).|3-month follow-up||||units on a scale; 0-21||Standard Deviation|Mean
1272639|NCT00333437|Secondary|Mean Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)|DLCO was measured before beginning and after completion of study therapy|12 months||||Liters||Standard Deviation|Mean
1272640|NCT00333437|Secondary|Mean Change in Six Minute Walk Distance|Comparison of 6-minute walk distance before beginning and after completing study therapy|12 months||||Feet||Standard Deviation|Mean
1272641|NCT00333437|Secondary|Change in Shortness of Breath (Self-reported)|Participants reported frequency of shortness of breath experienced with exertion|Baseline, 12 months||||participants|||Number
1272642|NCT00333437|Secondary|Mean Change in Bronchoalveolar Lavage (BAL) Components (Neutrophils, Eosinophils)|BAL samples were colleected from the affected lobe (as determined by lung CT scans) before beginning and after completing study therapy.|Baseline, 12 months||||Cells/uL||Standard Deviation|Mean
1272643|NCT00333437|Primary|Mean Change From Baseline in Forced Vital Capacity (FVC)|compare pre- and post-therapy FVC (post- minus pre-). Forced vital capacity (FVC) is the volume of air (liters) that can forcibly be blown out after full inspiration.|Baseline, 12 months||||Liters||Standard Deviation|Mean
1272644|NCT00333359|Secondary|Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity).|Baseline and Weeks 24 and 52|Safety Population: all participants who received one dose or any part of one dose of GEn. Results include only observed cases and do not include early termination values; as such the number of participants analyzed at each week differs from the number of participants in the Baseline characteristics summary.|||points on a scale||Standard Deviation|Mean
1272667|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Last observation (Up to 80 months in average)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.|||GD- enhanced T1 lesions||Standard Deviation|Mean
1272645|NCT00333359|Secondary|Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour.|Baseline and Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||hours||Standard Deviation|Mean
1272646|NCT00333359|Secondary|Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0.|Baseline and Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||percent change||Standard Deviation|Mean
1272647|NCT00333359|Secondary|Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||points on a scale||Standard Deviation|Mean
1272648|NCT00333359|Secondary|Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit.|Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||hours||Full Range|Median
1272649|NCT00333359|Secondary|Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data|In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM).|Week 52|Safety Population. Results at Week 52 include only Week 52 observed cases and do not include early termination values; as such, the number of participants with data at each time point differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
1272650|NCT00333359|Secondary|Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC|"The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study."|Weeks 0, 1, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
1272651|NCT00333359|Secondary|Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC|"The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse. Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved and improved, respectively."|Weeks 0, 1, 4, 12, 24, 36, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
1272652|NCT00333359|Secondary|Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC|"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study."|Weeks 0, 1, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
1272653|NCT00333359|Secondary|Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC|The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms.|Weeks 0, 1, 4, 12, 24, and 36|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||points on a scale||Standard Deviation|Mean
1282165|NCT00247273|Secondary|Change From Baseline in Serum CTX at Month 24, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 24|ITT|||ng / mL||95% Confidence Interval|Least Squares Mean
1272654|NCT00333359|Primary|Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC|"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved or improved, respectively."|Weeks 0, 1, 4, 12, 24, 36, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
1272655|NCT00333359|Primary|Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)|The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.|Baseline and Week 52|Safety Population: all participants who received one dose or any part of one dose of GEn. Week 52 (end of treatment) results included only Week 52 observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||points on a scale||Standard Deviation|Mean
1272656|NCT00333229|Secondary|Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months||2 years|||||||
1272657|NCT00333229|Secondary|Pathologic Fractures During 24 Month||2 years|||||||
1272658|NCT00333229|Secondary|Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)||2 years|||||||
1272659|NCT00333229|Secondary|Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months||2 years|||||||
1272660|NCT00333229|Primary|Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.||24 months|Analysis was not completed as study was not adequately powered due to premature study termination.||||||
1272661|NCT00333138|Secondary|Mean Trough Blood Concentrations of FTY720|For each patient, the arithmetic mean of the two FTY720 trough blood levels from month 3 and 6 was calculated. This was taken as the patient’s steady-state trough levels. Venous blood samples (3 mL) were collected before the dose in ethylenediaminetetraacetic acid (EDTA)-containing tubes at protocol-scheduled visits at months 3 and 6 in all patients.|Month 3 and 6|Pharmacokinetics population included all the patients who had sample collected and analysis was performed|||ng/mL||Standard Deviation|Mean
1272662|NCT00333138|Secondary|Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients|The Expanded Disability Status Scale (EDSS) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Month 6,12,60 and Last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. A patient at risk are those continuing in the study without an event before the specified timepoint The n denotes number of patients at risk."|||percentage of participants||95% Confidence Interval|Number
1272663|NCT00333138|Secondary|Change From Baseline in Volume of Total T2-weighted Lesions|Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume). The last observation was the last observation available for each patient which ranged from 1 to 2801 days.|Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"|||mm^3||Standard Deviation|Mean
1272664|NCT00333138|Secondary|Volume of T2-weighted Lesions|Volume of total T2-weighted lesions by visit were summarized. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"|||mm^3||Standard Deviation|Mean
1272665|NCT00333138|Secondary|Mean Number of New T2-weighted Lesions|New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (Month 1 to end of study) is calculated as the sum of the number of lesions at Months 1 to 6, Month 12, Month 60 and last observation. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"|||GD enhanced T2 lesions||Standard Deviation|Mean
1272666|NCT00333138|Secondary|Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit|A patient was defined as free of lesions if s/he had zero lesions. The sum of all new T2-weighted lesions at Month 1 to last observation was zero (the sum is missing if one of the assessments was missing). New T2 lesions at a specific visit were assessed relative to the previous visit scan. Exception: new T2 lesions at Month 24 were assessed relative to Month 12. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Month 6 and 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during core study were included in the ITT population. The n number of patients with T2 and T1 information recorded at scan"|||percentage of paticipants|||Number
1272668|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 60 (extension)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.|||GD- enhanced T1 lesions||Standard Deviation|Mean
1272669|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 12 (extension)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.|||GD- enhanced T1 lesions||Standard Deviation|Mean
1272670|NCT00333138|Secondary|Percentage of Participants Free of T1-weighted Lesions|A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis. The n in each category indicates number of patients wih information recorded at scan"|||percentage of participants|||Number
1272671|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 6 (Core)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.|||GD- enhanced T1 lesions||Standard Deviation|Mean
1272672|NCT00332839|Secondary|Changes in Proteinuria|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months|||||||
1272673|NCT00332839|Secondary|Changes in Cardiovascular Risk|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months|||||||
1272674|NCT00332839|Secondary|Number of Participants Who Experienced Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and deaths thorughout the prospective and follow-up phases of the study.|12 months|The safety set, which included all randomized participants, comprised the analysis population.|||Participants|||Number
1272675|NCT00332839|Secondary|Evolution of Renal Function|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months|||||||
1272676|NCT00332839|Secondary|Occurrence of Treatment Failures|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months|||||||
1272677|NCT00332839|Secondary|Biopsy Proven Acute Rejection, Graft Loss, and Death|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months|||||||
1272678|NCT00332839|Primary|Renal Function|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months|||||||
1272679|NCT00332722|Secondary|Neck Disability Index (NDI)|Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability.|2 years||||units on a scale||Standard Deviation|Mean
1272680|NCT00332722|Primary|Numeric Rating Scale (NRS)|Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.|over 2 years|A sample size of 60 patients for each group was chosen.|||units on a scale||Standard Deviation|Mean
1272681|NCT00332709|Secondary|Change in Z-Score From Baseline to Month 12|(DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis|Baseline, Month 12|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in this analysis|||Z-Score||Standard Deviation|Mean
1272682|NCT00332709|Secondary|Change in T-Score From Baseline to Month 12|BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.|Baseline, Month 12|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in this analysis.|||T-Score||Standard Deviation|Mean
1272683|NCT00332709|Primary|Change in Z Score From Baseline to Month 36|Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis.|Baseline, month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.|||Z-Score||Standard Deviation|Mean
1272697|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.|Day 1|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1272684|NCT00332709|Primary|Change in T-score From Baseline to Month 36|BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.|Baseline and Month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy.Participants with observations at both baseline and endpoint were included in the analysis.|||T-Score||Standard Deviation|Mean
1272685|NCT00332709|Primary|Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36|"Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA) scan.~ANCOVA model was used in the analysis where: Variable = Baseline, Center, Treatment BMD = (Month 36 BMD-Baseline BMD)/Baseline BMD*100."|Baseline, Month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.|||Percent Change in BMD||Standard Deviation|Mean
1272686|NCT00332709|Secondary|Median Disease Free Survival (DFS)|Disease Free Survival is measured in days and represents the number of days participants were progression free. Progression free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Median disease free survival is the time when 50% of the patients had a recurrence.|36 months|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. The median disease free survival was not observed because patients in the combination therapy did not have any recurrences.|||Months||95% Confidence Interval|Median
1272687|NCT00332709|Secondary|Number of Participants With Any Kind of Fractures, by Visit.|Number of participants with fractures of any type since the last visit|Baseline, Month 6, 12, 18, 24 , 30 and 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations from baseline to month 36 were included in this analysis.|||Participants|||Number
1272688|NCT00332709|Secondary|Change in Bone Mineral Density From Baseline to 12 Months|Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.|Baseline, 12 months|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.|||g/cm^2||Standard Deviation|Mean
1272689|NCT00332709|Primary|Change in Bone Mineral Density (BMD) From Baseline to Month 36|Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.|at 36 months as compared to baseline|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.|||Percent||Standard Deviation|Mean
1272690|NCT00332696|Secondary|Participant's Quality of Life Using the Edmonton Scale|The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse.|Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3|"Intent-to-treat population consisted of all participants who received at least one dose of study drug. n in each of the categories is the number of participants who had Quality of Life data at that time point."|||Scores on a scale||Standard Deviation|Mean
1272691|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|Month 3|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 3.|||Participants|||Number
1272692|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|Month 2|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 2.|||Participants|||Number
1272693|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|1 Month|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 1.|||Participants|||Number
1272694|NCT00332696|Secondary|Number of Participants With Relief From Obstruction at Day 7 and Day 14|Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours.|Day 7 and Day 14|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1272695|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14.|Day 14|Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 14.|||Participants|||Number
1272696|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7.|Day 7|Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 7.|||Participants|||Number
1275129|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|4 weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
1272699|NCT00332696|Secondary|Number of Participants With Treatment Success From Day 5 to Day 7|Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).|Day 5 to Day 7|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1272700|NCT00332696|Primary|Number of Participants With Treatment Success From Day 10 to Day 13|"Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.~Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause."|Day 10 to Day 13|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1272701|NCT00332644|Primary|7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed|Smoking status was assessed both as 7-day point-prevalence abstinence (“Have you smoked at all, even a puff, in the last 7 days?”) and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants’ self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).|6 months post quit date||||participants with<10 ppm exhaled CO|||Number
1272702|NCT00332605|Primary|Penn Craving Scale|used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.|beginning and at each visit until the end of their participation in the study|Reported scores are Mean and standard deviation for Subjects last visit (including last-observation carried forward).|||units on a scale||Standard Deviation|Mean
1272703|NCT00332579|Primary|Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)|The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).|K-YBOCS is done at each visit by the investigator.|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
1272704|NCT00332488|Secondary|Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)||Week 24|Intent to Treat: Subjects who stayed on original treatment|||percentage of total hemoglobin||Standard Deviation|Mean
1272705|NCT00332488|Secondary|Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue|(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)|Baseline to Week 12|Intention to Treat (ITT) Population for patients with available data|||Percentage of total hemoglobin||Standard Deviation|Mean
1272706|NCT00332488|Primary|Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue||Baseline to Week 12|Intention to Treat (ITT) Population with Last Observation Carried Forward|||Percentage of total hemoglobin||95% Confidence Interval|Least Squares Mean
1272707|NCT00332462|Secondary|Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation|The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months.|3 or 6 months after transplantation|Intention-to-treat (ITT) population.|||Participants|||Number
1272708|NCT00332462|Primary|Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation|Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.|3 months|Intention to treat (ITT) population|||Participants|||Number
1272709|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score|Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).|||Percent change||95% Confidence Interval|Mean
1272710|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis|Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).|||Percent change||95% Confidence Interval|Mean
1272711|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in Patient Global Assessment|Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).|||Percent change||95% Confidence Interval|Mean
1273440|NCT00327444|Secondary|60-Day Frequency of Paracentesis (FOP)|60-Day FOP was defined as the total number of paracenteses performed within the first 60 days after randomization during the double blind treatment period.|From Day 1 up to 60 days from randomization|The intent-to-treat (ITT) population - all participants who were randomized in the study.|||paracentesis||Standard Error|Least Squares Mean
1272712|NCT00332332|Primary|Participants With a Status of Mild or Better on Physician Global Assessment at Month 12|The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.|Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest. Missing post-baseline values were imputed using last observation carried forward.|||Participants|||Number
1272713|NCT00332241|Secondary|Change From Baseline in Body Weight|Adjusted mean change (Week 8 - baseline) in body weight|Week 8|Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Includes all participants with weight measurement at baseline and timepoint. Data set is LOCF.|||kilograms||Standard Error|Mean
1272714|NCT00332241|Secondary|Summary of Safety|Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation|continuous throughout the study|Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Data set is LOCF.|||participants|||Number
1272715|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient’s improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units on a scale||Standard Deviation|Mean
1272716|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores|Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units of a scale||Standard Error|Mean
1272717|NCT00332241|Secondary|Mean Change (Week 8 – Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)|CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units on a scale||Standard Error|Mean
1272718|NCT00332241|Secondary|Number of Participants With Response at Week 8|Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||participant|||Number
1272719|NCT00332241|Secondary|Mean Clinical Global Impressions Improvement Scale (CGI-I) Score|The CGI scale is a clinician-rated global assessment of a patient’s improvement over time. Baseline assessment rated a patient’s condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units on a scale||Standard Error|Mean
1272720|NCT00332241|Primary|Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score|The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units on a scale||Standard Error|Mean
1272721|NCT00332202|Secondary|Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte||Month 2, Month 4: Predose|All participants who received at least one dose of the study drug and had evaluable PK data.|||nanomole/liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1272722|NCT00332202|Secondary|Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression|Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: >=50% staining, low expression: <50% staining).|Baseline to 94.5 months|All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples.|||percentage of participants||95% Confidence Interval|Number
1272723|NCT00332202|Secondary|Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells|Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB.|Baseline to 24 months (2 years)|All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples.|||percentage of participants||95% Confidence Interval|Number
1272749|NCT00331864|Secondary|Total Number of Treatments|Total number of treatments administered during the entire treatment period (Month 0 to 11).|Baseline (Month 0) to Month 11|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.|||Treatments||Standard Deviation|Mean
1272724|NCT00332202|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) Score|The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates.|Baseline, Month 6; Baseline, Month 24; Baseline, Month 33|All randomized participants who completed at least one EQ-5D assessment.|||Units on a Scale||Standard Error|Mean
1272725|NCT00332202|Secondary|Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score|The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates.|Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36|All randomized participants who completed at least one FACT-Lym assessment.|||Units on a Scale||Standard Error|Mean
1272726|NCT00332202|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Number of participants with treatment-emergent adverse events.|First dose through 30 days post-study treatment discontinuation (up to 81.30 months)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1272727|NCT00332202|Secondary|Overall Survival|Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.|Baseline to Date of Death from Any Cause (up to 80.30 months)|All randomized participants. Overall survival is censored at the last date of contact for participants who have no reported death. The number of censored participant data for enzastaurin and placebo is 404 (80.2%) and 205 (80.7%), respectively.|||Month|||Number
1272728|NCT00332202|Secondary|Event-Free Survival at 2 Years|Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method.|Baseline to 2 Years|All randomized participants.|||Proportion of participants||95% Confidence Interval|Number
1272729|NCT00332202|Secondary|Event-Free Survival|Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.|Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)|All randomized participants. EFS is censored at the last assessable disease-free assessment for participants who are alive, have not progressed or started new anticancer treatment. The number of censored participant data for enzastaurin and placebo is 364 (72.2%) and 176 (69.3%), respectively.|||Month|||Number
1272730|NCT00332202|Secondary|Disease Free Survival at 2 Years|Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method.|Baseline to 2 Years|All randomized participants.|||proportion of participants||95% Confidence Interval|Number
1272731|NCT00332202|Primary|Overall Disease-Free Survival|Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.|Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)|All randomized participants. DFS is censored at the last assessable disease free assessment for participants who are alive or have not progressed. The number of censored participant data for enzastaurin and placebo is 369 (73.2%) and 180 (70.9%), respectively.|||Month||95% Confidence Interval|Median
1272732|NCT00332189|Secondary|Following Blood Phe Levels.|There were no pre-specified efficacy analysis, blood Phe samples were taken at each visit. Blood Phe concentrations remained within levels consistent with local clinical site recommendations for blood Phe control.|Baseline through Final Visit (a Maximum of 30 months) with blood phe samples taken at months 3 and 6 then at 6 month intervals|The population includes all subjects who received at least one dose of study drug during the study and had at least one measurement of blood Phe level.|||micromoles per liter||Standard Deviation|Mean
1272733|NCT00332189|Primary|Tabulation of the Incidence and Frequency of All AEs and SAEs That Occur Throughout the Study.|Safety was assessed with regards to the rate and type of AEs, clinically significant changes to vital signs and/or physical examination findings, and clinically significant changes in laboratory test results.|Baseline through Final Visit (a Maximum of 30 months) with AEs collected at month 3 and 6 then at 6 month intervals|Percentage of total population who experienced an AE or SAE presented here. For full list of SAEs, and AEs experienced with a frequency of greater than 5%, see the Reported Adverse Event section.|||percentage of subjects reporting events|||Number
1272815|NCT00331006|Secondary|Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event|Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.|||participants||Inter-Quartile Range|Median
1272734|NCT00332163|Secondary|Change From Baseline in Overall Dermatologic Quality of Life Index (DLQI) Score|Skin-related quality of life was assessed using the DLQI. The DLQI questionnaire asks participants to evaluate the degree that their skin condition has affected their quality of life in the last week. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); The DLQI score is calculated by summing the scores for all questions, resulting in a maximum of 30 and a minimum of 0; higher scores indicate a more impaired quality of life.|Baseline and Weeks 2, 3, 4, 5, 6 and 7|Patient Reported Outcomes (PRO) Analysis Set (randomized participants who signed informed consent before protocol-specified procedures, received at least 1 dose of panitumumab, with a non-missing baseline overall DLQI score and who had at least 1 post-baseline non-missing overall DLQI score) with available data at each time point.|||units on a scale||Standard Deviation|Mean
1272735|NCT00332163|Secondary|Progression-free Survival|Defined as the time from the date of randomization to the first date of observed disease progression or death due to any cause (whichever comes first). Participants who were alive and had not progressed while on study were censored at the date of last progression-free tumor assessment.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
1272736|NCT00332163|Secondary|Overall Survival|Overall Survival is defined as the time from the date of randomization to the date of death. Participants who did not die while on study or who were lost-to-follow-up were censored at their last contact date. Overall survival was analyzed using all data regardless of whether it was collected during second- or third-line treatment.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
1272737|NCT00332163|Secondary|Time to Progression|"Time from the date of randomization to the date of observed disease progression or death due to disease progression. Participants who did not have documented disease progression were censored at the date of last tumor assessment; participants who died for reasons other than disease progression while on study were censored at the date of death. PD: At least a 20% increase in the size of target lesions, recorded since the treatment started, or at least a 25% increase in size of non-target lesions and the lesion(s) measure > 10 mm in one dimension, or the appearance of one or more new lesions.~Time to progression was analyzed using the Kaplan-Meier method. This analysis excludes any data collected during follow-up for participants who began third-line treatment."|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
1272738|NCT00332163|Secondary|Time to Treatment Failure|Time-to-treatment failure is defined as the time from the date of randomization to the first date of any of the following events: discontinuation of study therapy due to any reason (except for complete response and curative surgery), progression of disease, or death due to any cause. Participants who did not discontinue, who were still alive, and who did not have disease progression were censored at the date of last contact. Time to treatment failure was analyzed using the Kaplan-Meier method.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
1272739|NCT00332163|Secondary|Rate of Disease Control at First Scheduled Assessment|Tumor response was assessed by CT scan or MRI of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified response evaluation criteria in solid tumors (RECIST). Disease control rate is defined as the percentage of participants with a CR, PR or stable disease (SD) at the Week 9/10 assessment visit and a corresponding response (CR or PR) confirmed at the Week 13/14 assessment visit for the Q2W/Q3W regimens. SD: Neither sufficient shrinkage or increase in target lesions to qualify for PR or PD, with no progression of non-target lesions and no new lesions.|Week 9 with confirmed response at Week 13 for the FOLFIRI and panitumumab Q2W regimen or at Week 10 with confirmed response at Week 14 for the irinotecan and panitumumab Q3W regimen.|Primary Analysis Set; participants who prematurely discontinued without a postbaseline tumor assessment or with an observed CR or PR at Week 9 or 10 that was not confirmed at Week 13 or 14 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
1272740|NCT00332163|Secondary|Best Overall Response Rate|Best overall response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) while on study. Tumor response was assessed by CT scan or MRI of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified RECIST criteria. CR: Disappearance of all target and non-target lesions and no new lesions. PR: Either the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or PD (≥ 25% increase in lesion size) and no new lesions, or, at least a 30% decrease in the size of target lesions with no progression of existing non-target lesions, and no new lesions.|Response was assessed at Weeks 9 and 13 and then every 8 weeks for the Q2W regimen, or at Weeks 10, 14, 22 and then every 9 weeks for the Q3W regimen until the end of treatment; median treatment duration was 13 and 17 weeks in each group respectively.|Primary Analysis Set; participants who prematurely discontinued without a post-baseline tumor assessment or with an observed CR or PR that was not confirmed were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
1272750|NCT00331864|Secondary|Time to the First Retreatment After Month 2|"Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.~Criteria for re-treatment:~a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3)~a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)"|Month 2 to Month 11|Intent-to-Treat (ITT) population patients: All patients who received study drug at least once and had at least one post-baseline efficacy assessment. The ANCHOR patients were not included in this analysis.|||Months||Inter-Quartile Range|Median
1272853|NCT00330681|Secondary|Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group||24 weeks|"1 patient with missing data was excluded from the FAS in the Placebo of MCI-186 group."|||percentage of participants|||Number
1272854|NCT00330681|Secondary|Percentage of Participants With Adverse Drug Reactions||24 weeks||||percentage of participants|||Number
1272741|NCT00332163|Secondary|Response Rate at First Scheduled Assessment|Tumor response was assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified response evaluation criteria in solid tumors (RECIST). Response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) at the Week 9/10 assessment visit and a corresponding CR or PR confirmed at the Week 13/14 assessment visit for the Q2W/Q3W regimens. CR: Disappearance of all target and non-target lesions and no new lesions. PR: Either the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD; ≥ 25% increase in lesion size) and no new lesions, or, at least a 30% decrease in the size of target lesions with no progression of existing non-target lesions, and no new lesions.|Week 9 with confirmed response at Week 13 for the FOLFIRI and panitumumab Q2W regimen or at Week 10 with confirmed response at Week 14 for the irinotecan and panitumumab Q3W regimen.|Primary Analysis Set; participants who discontinued prematurely without a post-baseline tumor assessment or with an observed CR or PR at Week 9 or 10 that was not confirmed at Week 13/14 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
1272742|NCT00332163|Secondary|Percentage of Participants With Panitumumab Dose Reductions Due to the Specific Skin Toxicities of Interest||6 weeks|Primary Analysis Set|||percentage of participants||95% Confidence Interval|Number
1272743|NCT00332163|Secondary|Time to First Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest|Time to the first most severe grade ≥ 2 of all the specific skin-related toxicities of interest was defined as the time from the first dose of panitumumab to the date of the first occurrence of the most severe specific ≥ grade 2 skin toxicity of interest during the 6-week skin treatment period. Participants who did not experience any specific skin-related toxicity of grade ≥ 2 were censored at their last skin toxicity assessment during the 6-week skin toxicity assessment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set|||weeks||95% Confidence Interval|Median
1272744|NCT00332163|Secondary|Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest|The percentage of participants with a most severe grade of 2, 3 or 4 specific skin toxicity of interest reported during the 6-week skin treatment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set|||percentage of participants||95% Confidence Interval|Number
1272745|NCT00332163|Secondary|Time to First Occurrence of Specific Grade 2 or Higher Skin Toxicities of Interest|The time to the first occurrence of specific grade 2 or higher skin toxicities of interest was defined as the time from the first dose of panitumumab to the date of first occurrence of specific ≥ grade 2 skin toxicities of interest. Participants who did not experience specific skin-related toxicities were censored at their last skin toxicity assessment during the skin toxicity assessment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set|||weeks||95% Confidence Interval|Median
1272746|NCT00332163|Secondary|Percentage of Participants With Any Grade 2 or Higher Skin Toxicity of Any Type During the 6-week Skin Treatment Period|The percentage of participants who developed at least 1 incidence of ≥ grade 2 skin toxicities of any type during the 6-week skin treatment period. Analysis of this endpoint was based on adverse event data associated with the “Skin and Subcutaneous Tissue Disorders” system organ class. Adverse events were graded according to the National Cancer Institute (NCI) CTCAE version 3.0.|6 weeks|Primary Analysis Set|||percentage of participants||95% Confidence Interval|Number
1272747|NCT00332163|Primary|Percentage of Participants With Specific Grade 2 or Higher Skin Toxicities During the 6-week Skin Treatment Period|Skin toxicities were assessed by the study clinician and graded according to the modified Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary analysis set (all randomized participants who provided informed consent before protocol-specific procedures and who received at least 1 dose of panitumumab)|||percentage of participants||95% Confidence Interval|Number
1272748|NCT00331864|Primary|Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye|"Grade 3 targeted AEs included:~4+ ocular inflammation or 2–3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days~≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection~sustained (>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a >20 mm Hg change in IOP persisting longer than 14 days~new retinal tear or detachment involving the macula~new vitreous hemorrhage >2+ severity not resolving within 14 days~new or increase of previous retinal hemorrhage >1 disc area in size and involving the fovea"|Baseline through end of study (12 month treatment period)|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.|||Percentage of Participants|||Number
1272771|NCT00331760|Secondary|Disease-free Survival||From registration to date of failure (any tumor recurrence, development of distant metastases or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
1272751|NCT00331864|Secondary|Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12|Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).|Baseline and Month 12|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.|||Micrometers||Standard Deviation|Mean
1272752|NCT00331864|Secondary|Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3|Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).|Baseline and Month 3|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.|||Micrometers||Standard Deviation|Mean
1272753|NCT00331864|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12|"BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.~BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity."|Baseline and Month 12|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.|||Letters on the ETDRS-like testing charts||Standard Deviation|Mean
1272754|NCT00331864|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3|"BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.~BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity."|Baseline and Month 3|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.|||Letters on the ETDRS-like testing charts||Standard Deviation|Mean
1272755|NCT00331864|Primary|Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye|Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.|Baseline through end of study (12 month treatment period)|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.|||Percentage of Participants|||Number
1272756|NCT00331799|Primary|Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks|CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience.|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1272757|NCT00331773|Other Pre-specified|Collection of Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses||From baseline to 5 years from the start of treatment.|||||||
1272758|NCT00331773|Secondary|Statistical Modeling of Genomic Biomarkers|Biomarker data has not been obtained yet therefore this analysis has not occurred.|Baseline biomarker collection will be used. Analysis occurs after the primary endpoint analysis.|||||||
1272759|NCT00331773|Secondary|Assessment of Trade-off Between Disease-free Survival and Quality of Life.|To examine trade-offs between the survival time and QOL, we were to combine them for each patient into two single measurements: quality adjusted live year (QALY) and quality adjusted disease-free survival year (QADFSY). We were to use Glasziou‘s multiple health-state (Q-TWiST) models to use the repeated measures of EQ-5D. This analysis was not conducted because there were no differences in EQ-5D scores. See results presented for Outcome Measure 10: Evaluation and Comparison of the Cost-utility of Each Treatment Arm Using EQ-5D.|From baseline to 5 years from the start of treatment|||||||
1272760|NCT00331773|Secondary|EQ-5D Scores|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 ―Worst health stat and 1 ―Best health state. A two-sided Wilcoxon test with alpha 0.05 was used due to the skewed, thus non-normal, nature of the data.|Baseline, 6 months, 12 months, 24 months, and 5 years|Eligible patients with a baseline or follow-up EQ-5D score who did not withdraw consent|||units on a scale||Inter-Quartile Range|Median
1272772|NCT00331760|Secondary|Distant Metastases||From registration to date of distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
1272773|NCT00331760|Secondary|Local-regional Failure||From registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
1272855|NCT00330681|Secondary|Percentage of Participants With Adverse Events||24 weeks||||percentage of participants|||Number
1272761|NCT00331773|Secondary|Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25|Anxiety and depression were measured with the Hopkins Symptom Checklist (HSCL-25). It consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms. The scale for each question includes four categories of response (“Not at all,” “A little,” “Quite a bit,” “Extremely,” rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items and ranges from 0 to 100. A higher score indicates worse symptoms. The HSCL-25 tool was assessed at baseline, 6 months, 12 months, 24 months, and 5 years. For each patient, the change in score from baseline to the time point is calculated by subtracting the baseline value from the time point value.|Baseline, 6 months, 12 months, 24 months, and 5 years|Eligible patients with a follow-up HSCL-25 who did not withdraw consent|||units on a scale||Standard Deviation|Mean
1272762|NCT00331773|Secondary|The Utilization of Sexual Medications/Devices Questionaire|"The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The percentage of Yes responses to the following questions are reported: Do you have a penile prosthesis, Have you used an medications or devices to aid or improve erections?."|Baseline, 6, 12, and 24 months, and 5 years|Eligible patients answering the questionaire, who did not withdraw consent|||percentage of participants|||Number
1272763|NCT00331773|Secondary|Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC|Prostate cancer (PC) Health-Related Quality of Life (HRQOL) outcomes as measured by change over time in the Expanded Prostate Cancer Index Composite [EPIC], a PC HRQOL instrument measuring a broad spectrum of urinary, bowel, and sexual symptoms related to radiotherapy, is compared between arms. The EPIC questionnaire was grouped into four domains (bowel, urinary, sexual, hormonal), each with a score ranging from 0 (worst) to 100 (best), and was assessed at baseline, 6, 12, and 24 months, and 5 years. The difference in score from baseline to each time point was calculated and the Wilcoxon test statistic was used to test the null hypothesis that responses are the same across the two treatment arms vs. the alternative hypothesis that they are different, using a 2-sided alpha of 0.05 at each timepoint, resulting in an alpha of 0.0125 for each domain. Each row refers to a separate analysis.|Baseline, 6, 12, and 24 months, and 5 years|Eligible patients with both a baseline and follow-up EPIC domain score, who did not withdraw consent|||units on a scale||Standard Deviation|Mean
1272764|NCT00331773|Secondary|Frequency of Patients With GU and GI Acute and Late Toxicity|The frequency of genitourinary (GU) and gastrointestinal (GI) adverse events as defined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) were compared between treatment arms. Acute toxicity was defined as any toxicity beginning within 90 days of completion of RT, and late toxicity was defined as any toxicity beginning more than 90 days after the completion of RT. Acute and late GU and GI toxicity rates were tabulated and reported in two ways: dichotomized as < grade 2 vs ≥ grade 2, and dichotomized as < grade 3 vs ≥ grade 3. Higher grade indicates more severity.|Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.|All eligible patients who started study treatment and did not withdraw consent|||participants|||Number
1272765|NCT00331773|Secondary|Five-year Overall Survival Rate|Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1272766|NCT00331773|Secondary|Five-year PSA Failure Rate|"Five-year rates are shown (cumulative incidence estimates). Note, although the protocol calls this endpoint Freedom from biochemical recurrence, it defines the endpoint as The time to PSA failure. An event for PSA, i.e. biochemical, failure was the first of the following: initiation of non-protocol (e.g., salvage) hormone therapy, or an increase in PSA of at least 2 ng/dl. Time to biochemical failure was measured from study entry until the date of failure."|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1272767|NCT00331773|Secondary|Five-year Disease-specific Survival Rate|"An event was death in association with any of the following conditions:~Primary cause of death certified as due to prostate cancer~Further clinical tumor progression occurring after initiation of salvage anti-tumor (e.g., (androgen suppression) therapy~A rise (that exceeds 1.0 ng/mL) in the serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy~Disease progression in the absence of any anti-tumor therapy~Death from a complication of therapy, irrespective of disease status. The arms were not statistically compared because of an insufficient number of events."|Analysis occurs after all patients have been followed for five years.|All eligible patients|||percentage of participants||95% Confidence Interval|Number
1272768|NCT00331773|Secondary|Five-year Local Progression Rate|Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.|Analysis occurs after all patients have been followed for five years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1272769|NCT00331773|Primary|Five-year Disease-free Survival (DFS) Rate|Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
1272770|NCT00331760|Secondary|Overall Survival||From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
1272777|NCT00331760|Primary|Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)|"Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%.~For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%."|IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.|All eligible patients.|||participants|||Number
1272778|NCT00331682|Secondary|Overall Survival|Will be computed using Kaplan-Meier methods.|Between the start of treatment until patient death, assessed up to 2 years||||months||Full Range|Median
1272779|NCT00331682|Secondary|Time to Progression|Will be computed using Kaplan-Meier methods.|Between the start of treatment until the criteria for progression are met, assessed up to 2 years||||weeks||Full Range|Median
1272780|NCT00331682|Primary|Objective Response Rate as Measured by RECIST Criteria|Objective response rate as measured by RECIST criteria|Up to 2 years||||participants|||Number
1272781|NCT00331552|Secondary|Comparison of Clinical Benefit Rate in 2 Subgroups--heavily Pre-treated (1 or More Regimens for Advanced Disease) vs Less Heavily Pre-treated (no Regimens for Advanced Disease) (Phase II)|Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).|Up to 24 weeks||||Participants|||Count of Participants
1272782|NCT00331552|Secondary|Overall Survival (Phase II)|Kaplan-Meier estimate assessed at 18 months|18 months||||survival probability||95% Confidence Interval|Number
1272783|NCT00331552|Secondary|Progression-free Survival (Phase II)|Kaplan-Meier estimate assessed at 18 months|18 months||||progression free survival probability||95% Confidence Interval|Number
1272784|NCT00331552|Secondary|Time to Progression (Phase II)|Median time to progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or new effusions.|Up to 2 years||||months||95% Confidence Interval|Median
1272785|NCT00331552|Secondary|Treatment-related Toxicity (Phase I)|Count of phase I participants with treatment related toxicity.|Up to 24 weeks||||Participants|||Count of Participants
1272786|NCT00331552|Primary|Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation|Count of participants with grade 1, 2, 3, 4, fatal toxicity, need for dose reduction, treatment interruption, or treatment discontinuation|Periodically during study treatment, up to 24 weeks||||Participants|||Count of Participants
1272787|NCT00331552|Primary|Efficacy as Assessed by the Overall Clinical Benefit Rate|Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).|18 months||||Participants|||Count of Participants
1272788|NCT00331552|Primary|Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I)|The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment|Up to 24 weeks||||mg/m^2|||Number
1272789|NCT00331422|Secondary|Quality of Life Score of Patients Receiving Neoadjuvant Chemotherapy|"Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire was used to assess the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. It is a 5 point scale (from worse to best: 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much responses). Physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns questions are asked.~Unable to evaluate; patients did not consistently complete the questionnaires."|Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment)|||||||
1272790|NCT00331422|Secondary|Change in Thrombospondin-1 (TSP-1), p53, and Tumor Vessel Density|Unable to report due to incomplete (nonviable) or unsatisfactory tissue samples.|Week 18 (At surgery)|||||||
1272791|NCT00331422|Secondary|Change in Drug Resistance After Neoadjuvant Chemotherapy|As measured by extreme drug resistance assay - Unable to report due to tissue samples being incomplete or unsatisfactory to do laboratory testing.|Day 1 to Time to Surgery (Approximately Week 18)|||||||
1272792|NCT00331422|Secondary|Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration|Ca-125 serum results compared from baseline to after patient's last treatment. This is a tumor biomarker. A decrease in results indicates a clinical response.|From Baseline to up to 12 weeks (4 courses of therapy)||||Participants|||Number
1272793|NCT00331422|Secondary|Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from start of treatment until after 4th cycle of treatment. Defined by the sum of Complete Responses (CR), Partial Responses (PR), and Stable Disease (SD) in patients neoadjuvant chemotherapy. CR=disappearance of all lesions, PR=>or=30% decrease in sumof all target lesins, Progressive Disease (PD) =>or =20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.|Week 16 (4 weeks after 4th course)||||Participants|||Number
1272794|NCT00331422|Primary|Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy|These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.|Week 18 (After 4 cycles of chemotherapy)|Includes those patients that received 4 cycles of therapy before removal of cancerous tissue. Evaluation of overall response is not possible due to low number of patients and therefore could not obtain statistical significance.|||Participants|||Number
1272795|NCT00331409|Secondary|Number of Participants With Adverse Events|"Toxicity assessments will be obtained as follows:~Cycle 1: Weeks 1,2,3 Cycle 2: Weeks 6,9 Cycle 3: Weeks 12, 15 Cycle 4: Weeks 18, 21 Cycle 5: Weeks 24, 27 Cycle 6+: Every visit during these cycles~Safety assessments will consist of evaluating adverse events and serious adverse events."|Duration of study, Up to 4 years||||participants|||Number
1272796|NCT00331409|Secondary|Number of Subjects That Demonstrated a Reduction in Tumor Measurements.|Number of subjects that received at least one post-baseline scan that demonstrated a reduction in sum target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|Up to 4 years|2 subjects were not evaluable. Reduction in target lesion sum did not meet the criteria for Partial Response (PR) for any of the subjects. Partial Response, per RECIST, includes at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|||Participants|||Count of Participants
1272797|NCT00331409|Secondary|Median Time to Progression||Time to progression||||months||95% Confidence Interval|Median
1272798|NCT00331409|Primary|Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months||Up to 4 years||||participants|||Number
1272799|NCT00331409|Primary|Progression-free Survival at 3 Months||3 months post 1st dose||||months||95% Confidence Interval|Median
1272800|NCT00331344|Secondary|Time to Progression (Phase II)|Measured from the start of protocol therapy until RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.0 progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 3 months until cancer progression/excessive toxicity or death||||months||95% Confidence Interval|Median
1272801|NCT00331344|Primary|Dose Limiting Toxicities for Each Dose Level of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I).|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the maximum tolerated dose (MTD). If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m^2. Toxicities will be tabulated by grade for each dose cohort and overall for all patients accrued to the phase I study.|Course 1 (first 21 days)|Dose escalation safety study (Phase I)|||Participants|||Count of Participants
1272802|NCT00331344|Primary|Safety of the Combination of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I)|This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The cumulative grade 3 or higher adverse events for all dose levels are noted below and in the table of adverse events.|Every 21 days until cancer progression/excessive toxicity or death|Phase I dose escalation study participants|||Adverse Events (above threshold)|||Number
1272803|NCT00331344|Primary|Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II)|"Descriptive statistics will be calculated to characterize the disease and treatment factors including the proportion responding with a 95% confidence interval. If accrual is completed and more than 15 of 58 patients show > 50% Prostate Specific Antigen (PSA) declines after 3 courses, then the null hypothesis of a 20% response proportion will be rejected. PSA declines for individual patients will be plotted in the form of a waterfall diagram of maximal PSA declines.~58 patients were enrolled for phase II, two were ineligible so 56 patients were analyzed."|Every 3 courses until cancer progression/excessive toxicity or death||||Participants|||Count of Participants
1272804|NCT00331162|Secondary|Health Status and Quality of Life||2 years|No data was collected.||||||
1272805|NCT00331162|Secondary|Cost||2 years|No data was collected||||||
1272806|NCT00331162|Secondary|Other Adverse Events|Number of patients with other adverse events (posttransplant lymphoproliferative disorder (PTLD), and nonskin malignancy), were reported.|2 years||||Participants|||Count of Participants
1272807|NCT00331162|Secondary|Infectious Adverse Events|Number of events for infectious adverse events were reported (Polyoma virus nephropathy (PVD), cytomegalovirus (CMV), bacterial and fungal infections).|2 years||||number of events|||Number
1272808|NCT00331162|Secondary|Hematologic Adverse Events||2 years|No data was collected||||||
1272809|NCT00331162|Primary|Acute Rejection|The number of patients with acute rejection after transplantation was reported.|5 years||||Participants|||Count of Participants
1272810|NCT00331162|Primary|Graft Survival|The number of patients with graft survival after kidney alone, simultaneous pancreas-kidney (SPK), and pancreas after kidney (PAK) transplant.|5 years|Number the analyzed in one or more rows differs from overall number analyzed because there were subgroups for transplantation.|||Participants|||Count of Participants
1272811|NCT00331162|Primary|Patient Survival|The number of patients that survived after transplantation occurred was reported.|5 years||||Participants|||Count of Participants
1272812|NCT00331006|Secondary|Proportion of Rituximab Infusions in Which a Reaction to the Infusion Was Reported|Proportion of rituximab infusions in which a reaction to the infusion was reported|Measured at Week 1 through Week 4|All rituximab infusions given to study participants|||proportion of rituximab infusions|Participants|95% Confidence Interval|Number
1272813|NCT00331006|Secondary|Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event|Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.|||participants||Inter-Quartile Range|Median
1272814|NCT00331006|Secondary|Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events|Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.|||participants||Inter-Quartile Range|Median
1282166|NCT00247273|Secondary|Percent Change From Baseline in Serum CTX at Month 6, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 6|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
1272816|NCT00331006|Secondary|Median Number of Bleeding Events Per Subject Meeting the Criteria of a Serious Adverse Event|Median number of bleeding events per subject meeting the criteria of a serious adverse event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.|||participants||Inter-Quartile Range|Median
1272817|NCT00331006|Secondary|Percent Change in Inhibitor Titer on Challenge With Factor VIII From Baseline Challenge to Post-treatment Challenge|percent change=100%*(A-B)/B where A=inhibitor titer measured within 5-7 days following FVIII rechallenge and B=inhibitor titer measured within 5-14 days following baseline FVIII challenge. A FVIII rechallenge was performed within 10-18 days of the first monthly study visit in which an inhibitor titer result <5 BU/mL was obtained beginning 2 weeks and continuing through 18 weeks following the last rituximab infusion.|Measured within approximately 22 weeks|All subjects who received a post-treatment rechallenge and had at least a minor response.|||percentage change||Inter-Quartile Range|Median
1272818|NCT00331006|Secondary|Proportion of Subjects With at Least Minor Response, i.e. Inhibitor Level Falls to <5 BU/mL Between Weeks 6-22 and Either Remains <5 BU/mL 5-7 Days Following FVIII Rechallenge or Titer Following FVIII Rechallenge is 5-10 BU/mL & <50% of Original Peak|Presence or absence of at least a minor response in each participant|Measured within approximately 22 weeks|All participants who received at least one dose of rituximab|||proportion of participants||95% Confidence Interval|Number
1272819|NCT00331006|Primary|Proportion of Subjects With Major Response, i.e. Inhibitor Level Falls to Less Than 5 BU/mL Between Weeks 6 to 22 and Remains Below 5 BU/mL at 5-7 Days Following Re-challenge With FVIII|Presence or absence of a major response in each participant. Major response is defined as occurring when inhibitor level falls to less than 5 BU/mL between Weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with FVIII|Measured within approximately 22 weeks|All participants who received at least one dose of rituximab|||proportion of participants||95% Confidence Interval|Number
1272820|NCT00330967|Primary|JNK MAPK Expression With Femoral Lipid and Insulin Infusions|JNK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
1272821|NCT00330967|Primary|Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of JNK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
1272822|NCT00330967|Primary|ERK MAPK Expression With Femoral Lipid and Insulin Infusions|ERK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
1272823|NCT00330967|Primary|Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of ERK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
1272824|NCT00330967|Primary|p38 MAPK Expression With Femoral Lipid and Insulin Infusions|p38 MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
1272825|NCT00330967|Primary|Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of p38 MAPK in response to femoral lipid and insulin infusions. phospho-p38 MAPK expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
1272826|NCT00330967|Primary|Insulin Signaling With Lipid Infusion|IRS-1 expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.|4 h||||ratio||Standard Deviation|Mean
1272827|NCT00330928|Secondary|Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.|Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated relation to baseline presence of lipid signals by near infrared spectroscopy. This study is not powered to reach statistical significance for this outcome.|1 year|||||||
1272828|NCT00330928|Secondary|Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment|Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated for being categorized as Definitely attributable to the study device.|Baseline to 7 day|All patients that were enrolled, intent to treat population, were evaluated for definite or probable relation to the investigational device. This includes 7 subjects that were not exposed to the investigational device.|||participants|||Number
1272829|NCT00330928|Secondary|Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics||Baseline|||||||
1272830|NCT00330928|Secondary|Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes|This is an exploratory examination to determine if an association exists between the presence or characteristics of lipid core plaques of interest signals and the clinical designation of acute or stable coronary artery disease in enrolled subjects. The study is not powered for statistical significance for this outcome.|Baseline|||||||
1272939|NCT00329784|Secondary|Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L|At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific food sensitivity if a blood draw showed specific IgE levels greater than or equal to 0.35 kU/L for selected ingested allergens.|60 months|Intent-to-treat with data available|||Participants|||Count of Participants
1272831|NCT00330928|Primary|Spectral Similarity|Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was >=67%, on a continuous range of 0%(different) to 100%(identical) similarity.|Baseline|58 Subjects were excluded from endpoint analysis for No NIRS data(17), Inadequate data per protocol(11), and Data Accessible during comparison set generation(30).A similarity success was met if >80% of the NIRS data for a subject was similar to the autopsy NIRS set.|||percent similarity||95% Confidence Interval|Mean
1272832|NCT00330915|Secondary|Number of Participants Receiving Sphincter Saving Surgery||surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.|||participants|||Number
1272833|NCT00330915|Secondary|Number of Participants With Complete Tumor Resection||surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.|||participants|||Number
1272834|NCT00330915|Secondary|Pathological Complete Response (pCR)|Pathological complete response was defined as the absence of any tumor cells.|surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.|||participants|||Number
1272835|NCT00330915|Primary|Feasibility of Pemetrexed Prior to Surgery|Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.|3 cycles (21-day cycles)|Number of participants enrolled.|||participants|||Number
1272836|NCT00330876|Secondary|Change From Baseline in Total Cholesterol|Percent change from baseline in total cholesterol (TC)|Baseline to 60 weeks|Subjects with a measurement at Week 60|||percent change||Standard Deviation|Mean
1272837|NCT00330876|Primary|Change From Baseline in LDL-C|percent change from baseline in low density lipoprotein-cholesterol (LDL-C)|Baseline to 60 weeks|Subjects with measurement at Week 60|||percent change||Standard Deviation|Mean
1272838|NCT00330863|Secondary|Side Effects and Metabolic Measures|The highest severity of each of 24 adverse event (AE) that was assessed.over the 30 month study period. The mean severity on a scale of 1 (none) to 4 very severe symptom was recorded at each biweekly visit. Results for each variable are summarized over time so that each subject has a single mean severity rating for each AE. There is no named scale. Each of the side effects measured is named in ways that are clear to medical readers e.g anorexia. The range is 1 none to 4 very severe. Therefore, a higher scale score is worse.|Measured throughout study up to 30 months||||units on a scale||Standard Deviation|Mean
1272839|NCT00330863|Secondary|Quality of Life Measures|Scale of Functioning (SOF)|Measured throughout study up to 30 months|No data displayed because Outcome Measure has zero total participants analyzed. Data not collected.||||||
1272840|NCT00330863|Secondary|Control of Psychiatric Symptoms|Brief Psychiatric Rating Scale (BPRS) total score|Measured throughout study up to 30 months|These data were not collected. No data displayed because Outcome Measure has zero total participants analyzed.||||||
1272841|NCT00330863|Secondary|Number of Days in Hospital||Measured throughout study up to 30 months|These data were not collected.||||||
1272842|NCT00330863|Secondary|Number of Patients Discontinuing From the Study||Measured throughout study up to 30 months||||participants|||Number
1272843|NCT00330863|Primary|Substantial Clinical Deterioration Measured by Psychotic Symptoms|Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms.|Measured throughout study up to 30 months|We conducted a mixed model regression analysis with two treatment groups X time psychosis cluster scores at each 3 monthly observation from baseline to 30 months. Missing data were treated as MAR|||units on a scale||95% Confidence Interval|Least Squares Mean
1272844|NCT00330759|Secondary|Time to the First-and-Subsequent On-Study Skeletal-Related Event|"Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE.~This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events."|up to 33 months|Full Analysis Set, composed of all randomized participants|||Events|||Number
1272845|NCT00330759|Secondary|Time to First On-Study Skeletal-Related Event (Superiority)|Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.|up to 33 months|Full Analysis Set, composed of all randomized participants.|||Days||95% Confidence Interval|Median
1272846|NCT00330759|Primary|Time to the First On-Study Skeletal-Related Event (Non-Inferiority)|Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.|up to 33 months|Full Analysis Set, composed of all randomized participants.|||Days||95% Confidence Interval|Median
1272847|NCT00330733|Secondary|Endothelial Dysfunction||8 and 12 weeks|||||||
1272848|NCT00330733|Secondary|Parameters of Cardiovascular Disease Risk, Including Glucose, Triglycerides, HDL and Blood Pressure||8 and 12 weeks||2013-09-30|09/2013||||
1272849|NCT00330733|Secondary|Plasma Levels of a Variety of Inflammatory Proteins||8 and 12 weeks|||||||
1272850|NCT00330733|Secondary|Glucose Area Under the Curve in These Subjects||3 months|||||||
1272851|NCT00330733|Primary|Change in Systemic Glucose Disposal- Glucose Infusion Rates|Participants were admitted to the Clinical Research Units at 06:00–08:00 hours after an overnight fast. Euglycaemic–hyperinsulinaemic clamps were conducted at baseline and at the end of the study. Because salsalate therapy appears to decrease insulin clearance leading to higher circulating insulin levels during the clamp, we reduced the infusion rate of insulin in the active treatment arm by 20% (from 100 to 80 mUm−2 min−1) at the study end. Insulin solutions were prepared by the site pharmacist so that study staff remained blinded to drug assignment. Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of insulin infusions.|3 months|analysis was performed on all participants with available baseline and final clamp studies|||percent change from baseline||95% Confidence Interval|Median
1272852|NCT00330681|Secondary|Percentage of Participants With Abnormal Changes in Sensory Examinations||24 weeks||||percentage of participants|||Number
1272856|NCT00330681|Secondary|Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks|The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40|baseline and 24 weeks|"1 patient with diseases other than ALS, 1 patient who did not reach the end of cycle 3 and 5 patients with missing data were excluded from the FAS in the MCI-186 group.~5 patients who did not reach the end of cycle 3 and 4 patients with missing data were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
1272857|NCT00330681|Secondary|Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks|The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102|baseline and 24 weeks|"1 patient with diseases other than ALS, 1 patient who did not reach the end of cycle 3 and 5 patients with missing data were excluded from the FAS in the MCI-186 group.~5 patients who did not reach the end of cycle 3 and 2 patients with missing data were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
1272858|NCT00330681|Secondary|Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks||baseline and 24 weeks|"1 patient with diseases other than ALS and 1 patient who did not reach the end of cycle 3 were excluded from the FAS in the MCI-186 group.~5 patients who did not reach the end of cycle 3 were excluded from the FAS in the Placebo of MCI-186 group."|||percentage of FVC||Standard Error|Least Squares Mean
1272859|NCT00330681|Secondary|Death or a Specified State of Disease Progression|Any of “death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding” was defined as an event.|24 weeks|"1 patient with diseases other than ALS was excluded from the FAS in the MCI-186 group."|||participants|||Number
1272860|NCT00330681|Primary|Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks|ALSFRS-R Score: 0=worst; 48=best|baseline and 24 weeks|"1 patient with diseases other than ALS and 1 patient who did not reach the end of cycle 3 were excluded from the FAS in the MCI-186 group.~5 patients who did not reach the end of cycle 3 were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
1272861|NCT00330668|Secondary|Height SD Score||during the course of the study||||SD score||Standard Deviation|Mean
1272862|NCT00330668|Secondary|Height Velocity Standard Deviation (SD) Score||during the course of the study||||SD score||Standard Deviation|Mean
1272863|NCT00330668|Secondary|Height Velocities During Subsequent Years of rh IGF-1 Treatment|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|after 2, 3 and 5 years of treatment||||cm/year||Standard Deviation|Mean
1272864|NCT00330668|Primary|Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily)|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|after one year of treatment||||cm/year||Standard Deviation|Mean
1272865|NCT00330616|Secondary|Serious Adverse Events||Baseline through Week 8|Safety population - all subjects who took at least one dose of study medication.|||Participants|||Number
1272866|NCT00330616|Secondary|Adverse Events (>=5% Incidence)||Baseline through Week 8|Safety population - all subjects who took at least one dose of study medication.|||Participants|||Number
1272867|NCT00330616|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8|The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Weeks 1, 2, 3, 4, 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
1272868|NCT00330616|Secondary|Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.|Week 4 and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Responders|||Number
1272869|NCT00330616|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Week 4 and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
1272870|NCT00330616|Secondary|Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Change||Standard Deviation|Mean
1272940|NCT00329784|Secondary|Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm|At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific sensitivity if a skin prick containing the allergen produced a wheal size measuring greater than or equal to 3 mm.|60 months|Intent-to-treat with data available|||Participants|||Count of Participants
1272871|NCT00330616|Secondary|Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Change||Standard Deviation|Mean
1272872|NCT00330616|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
1272873|NCT00330616|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
1272874|NCT00330616|Secondary|Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.|Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Remitters|||Number
1272875|NCT00330616|Secondary|Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.|Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Remitters|||Number
1272876|NCT00330616|Secondary|Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.|Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Responders|||Number
1272877|NCT00330616|Secondary|Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.|Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Responders|||Number
1272878|NCT00330616|Secondary|Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Change||Standard Deviation|Mean
1272879|NCT00330616|Secondary|Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Change||Standard Deviation|Mean
1272880|NCT00330616|Primary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8|The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
1272927|NCT00329849|Secondary|Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS|Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 to 7 postvaccination|Analysis was performed on safety dataset. Groups were sub-divided into 2 to 5 years of age and 6 to 10 years of age.|||participants|||Number
1272881|NCT00330564|Primary|Safety of Sunitinib Administration in Participants With Von Hippel-Lindau Syndrome (VHL)|Safety evaluation = Number of participants with treatment terminating toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0. Early stopping rules applied when treatment terminating toxicity occurred in the first 6 week cycle. Recurring grade 3 toxicity requires dose reduction, with no more than 2 dose reductions permitted. If no improvement after 4 weeks, patient is taken off drug and off study, and the event recorded as treatment terminating toxicity.|12 weeks|Intent to treat once the first dose was taken.|||participants|||Number
1272882|NCT00330564|Secondary|Number of VHL Lesion Complete + Partial Responses|Response of VHL lesions (number) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): 20% increase in LD sum and Stable Disease (SD): Insufficient shrinkage to qualify for PR nor increase to qualify for PD. Degree and timing of response in affected organs evaluated in order to determine organ specific kinetics of therapy.|Baseline to 12 months (evaluations at 6 and 12 months)|Secondary end point of efficacy showed response of renal cell carcinomas, which responded better to sunitinib therapy than other VHL related lesions using RECIST measure.|||VHL lesion|Participants||Number
1272883|NCT00330460|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1272884|NCT00330460|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1272885|NCT00330460|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1272886|NCT00330460|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1272887|NCT00330460|Primary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|Randomized subjects who have a nonmissing baseline and at least 1 nonmissing postbaseline evaluation at or prior to month 12. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1272888|NCT00330421|Primary|Incidence of Adverse Events||Up to 1 month|||||||
1272889|NCT00330421|Primary|Clinical Benefit, Measured by Any Reduction in Tumor Dimensions on CT Scan as Measured by RECIST Criteria||Up to 1 month|||||||
1272890|NCT00330421|Primary|Clinical Benefit as Measured by 50% Reduction in IFP||Baseline to surgery|||||||
1272891|NCT00330421|Primary|Change in Pericyte Coverage of Endothelial Cells (Alpha-SMA)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|||||||
1272892|NCT00330421|Primary|Change in White Blood Cell Count (WBC)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|||||||
1272893|NCT00330421|Primary|Change in Interstitial Fluid Pressure (IFP)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|IFP measurements were obtained in only 6 of 15 patients at baseline. Only 2 of these 6 patients had SD at 28 and 56 days and therefore, second IFP measurements were only obtained in those 2 patients.|||mm Hg||Full Range|Mean
1272894|NCT00330421|Primary|Change in Fludeoxyglucose (FDG) Uptake (Maximal Standardized Uptake Value, or SUVmax)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|||||||
1272895|NCT00330382|Secondary|Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months||Baseline to 6 months|The participants whose data are available and complete are included in the analysis.|||percentage change||95% Confidence Interval|Median
1272896|NCT00330382|Secondary|Number of Participants Report at Least 1 Adverse Event During the Study|The onset of adverse event is between the randomizaiton date and off-study date|Randomized date to Off-study date, up to 21 months||||participants|||Number
1272897|NCT00330382|Secondary|Relative Percent Change in Protease Activity (Delta RFU/Min/µg)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.|||percentage change||95% Confidence Interval|Median
1272898|NCT00330382|Secondary|Relative Percent Change in Serum Neu Protein (ng/ml)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.|||percentage change||95% Confidence Interval|Median
1272899|NCT00330382|Secondary|Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.|||percentage change||95% Confidence Interval|Median
1272900|NCT00330382|Secondary|Clinical Impression From Photographs|A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, “top photo shows a complete response relative to the bottom photo,” through, “the same degree of disease is shown by top photo and bottom photo,” to “bottom photo shows a complete response relative to the top photo.” Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo.|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.|||score||Standard Deviation|Mean
1272901|NCT00330382|Primary|Number of Participants by Category of Clinical Response at 6 Months|Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease.|6 months|The participants who have complete data are analyzed in this outcome measure.|||participants|||Number
1272902|NCT00330382|Secondary|The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen|The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word ‘Normal’ on the left and ‘Malignant’ on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from ‘Malignancy’ over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period.|Baselie to 6 months|The participants who have complete data are analyzed in this outcome measure.|||score||Standard Deviation|Mean
1272903|NCT00330382|Primary|Relative Percent Change in Total Lesion Area After 6 Months on Study|Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.|6 months|The participants who have complete data are analyzed in this outcome measure.|||percentage change||Standard Deviation|Mean
1272904|NCT00330343|Primary|Number of Participants With Naloxone Side Effects|incidence of nausea, vomiting, pruritus following naloxone infusion|0-48 hours after infusion begins||||participants||95% Confidence Interval|Number
1272905|NCT00330187|Primary|Biologically-verified 7-day Point Prevalence Smoking Abstinence|Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL|End of treatment (week 6)|Intent-to-treat analysis|||participants|||Number
1272906|NCT00330174|Secondary|Hospital Anxiety and Depression Scale|This is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.|12 weeks||||units on a scale||Standard Error|Mean
1272907|NCT00330174|Secondary|Liebowitz Social Anxiety Scale|The LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.|12 weeks||||units on a scale||Standard Error|Mean
1272908|NCT00330174|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|This 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.|12 weeks||||units on a scale||Standard Error|Mean
1272909|NCT00330174|Primary|Percent Days Drinking|Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.|12 weeks|The primary outcome measure is difference in cumulative days abstinent. Based on the meta-analysis by Mann et al (2004). A total sample of 90 participants would be able to detect a difference of 11 (+/- 18) days between acamprosate and placebo groups with 80% power, and Type 1 error rate of 0.05.|||percentage of days drinking||Standard Error|Mean
1272910|NCT00330161|Secondary|Objective Response Rate|Percentage of participants that obtain the best objective response, stable disease.|Up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.|||percentage of participants|||Number
1272911|NCT00330161|Secondary|Median Survival|Median overall survival.|Up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis. Of the 27 patients analyzed, one patient was censored with an outlying overall survival of 15.1 months.|||months||Full Range|Median
1272912|NCT00330161|Secondary|Progression-free Survival|Median time to progression was determined.|From the start of treatment to time of progression, assessed up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.|||months||Full Range|Median
1272913|NCT00330161|Secondary|Rate of PSA Decline|Rate of Prostate Specific Antigen (PSA) decline of greater than or equal to 50%.|Up to 3 years|No PSA declines of greater than or equal to 50% were observed, therefore the rate could not be determined.||||||
1272914|NCT00330161|Secondary|Incidence of Toxicity|The percentage of eligible participants that experience grade 3 or 4 toxicities.|Up to 3 years|Of the 29 patients enrolled, 2 were deemed ineligible after treatment and therefore excluded from outcome analysis.|||percentage of participants|||Number
1272915|NCT00330161|Primary|Proportion of Patients Who do Not Demonstrate Disease Progression|Fisher’s Exact Test will be used.|At 6 months|The primary objective was to determine the number of patients wtih progression-free survival at 6 months. Unfortunately all eligible patients were off therapy before the 6 month time point. 13 (48%) were removed due to progression, 11 (41%) secondary to toxicity, and 3 (11%) for other reasons.||||||
1272916|NCT00329901|Secondary|Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo|The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.|Throughout the study (Day 1 to Day 181)|This analysis was done on the safety population.|||Participants|||Number
1272954|NCT00329719|Secondary|Objective Response, as Determined by a Neurological Exam, MRI, and/or CT Measurement|The proportion of patients in each response category will be summarized and 90% confidence intervals calculated assuming that the incidence of response is binomially distributed.|Up to 5 years||||proportion of patients||90% Confidence Interval|Number
1272917|NCT00329901|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo|Day 1-7 after any vaccination|Analysis was done on the safety population|||Participants|||Number
1272918|NCT00329901|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.|Day 1-7 after any vaccination|Analysis was done on the safety population|||Participants|||Number
1272919|NCT00329901|Secondary|Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|"The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.~Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer."|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1272920|NCT00329901|Secondary|Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Ratios||95% Confidence Interval|Geometric Mean
1272921|NCT00329901|Secondary|The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1272922|NCT00329901|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|"The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.~The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA)."|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1272923|NCT00329901|Secondary|Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo|The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
1272924|NCT00329901|Secondary|Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo|The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
1272925|NCT00329901|Secondary|Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo|The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1272926|NCT00329901|Primary|Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo|"To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of~the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and~the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA)."|1 month after vaccination (Day 29)|Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding|||Percentages of subjects||95% Confidence Interval|Number
1272955|NCT00329719|Secondary|Overall Survival|The overall survival distribution will be estimated using the method of Kaplan-Meier.|From start of study registration to death due to any cause or until last follow-up, up to 5 years||||months||95% Confidence Interval|Median
1272928|NCT00329849|Secondary|The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS|The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS|Day 181|Analysis was performed on the PP dataset for persistence analysis at day 181.|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
1272929|NCT00329849|Secondary|Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS|The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.|Day 181|Analysis was performed on PP dataset for persistence analysis at day 181.|||Percentage of subjects||95% Confidence Interval|Number
1272930|NCT00329849|Secondary|The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 and 29|Analysis was performed on the PP dataset of primary vaccination.|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
1272931|NCT00329849|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 and 29|Analysis was performed on the PP dataset of primary vaccination.|||Percentage of subjects||95% Confidence Interval|Number
1272932|NCT00329849|Primary|Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination|Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.|Day 1 to 7 postvaccination|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1272933|NCT00329849|Primary|Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|"Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine.~Seroresponse was defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8;~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|1 month after vaccination (day 29)|Analysis was done on the per-protocol (PP) dataset of primary vaccination, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at one month after vaccination; and had no major protocol violations as defined in the analysis plan.|||Percentage of subjects||95% Confidence Interval|Number
1272934|NCT00329836|Primary|Prevalence of Allodynia in Subjects With Cluster Headache|Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.|Allodynia was assessed at the screening visit|N/A. No lost to follow-up or missing data. All enrolled subjects were analyzed|||participants|||Number
1272935|NCT00329797|Secondary|Utility of the Use of Bisphosphonates as Assessed by Quality-adjusted Survival|The EQ-5D is a standardized instrument for measuring generic health status used to generate health utilities, used to derive quality adjusted survival. Quality adjusted survival is computed using the weighted sum of times in different health states added up to a total quality-adjusted survival time. The log-rank test is used to compare quality-adjusted survivals between the treatment arms.|From pre-treatment to 3 years from start of treatment|Eligible patients with baseline and follow-up EQ-5D scores, resulting in only 59 patients (no deaths), less than half of enrolled patients (and less than 5% of planned enrollment), which is extremely problematic as it can lead to selection bias, especially with even fewer patients with follow-up scores. Therefore analysis was not conducted.||||||
1272936|NCT00329797|Secondary|Changes in the Functional Assessment of Cancer Therapy-General (FACT-G) at 3 Years|The FACT-G is a validated, 27-item measure. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for the physical, social and functional subscales, and 0-24 for the emotional subscale. Certain items, identified on the FACT-G scoring guides, must be reversed before it is added by subtracting the response from 4. All subscale totals are added together to form the FACT-G total score. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL.|Baseline, 3 years from start of treatment|Eligible patients with baseline and 3-year FACT-G data|||units on a scale||Full Range|Mean
1272937|NCT00329797|Secondary|Percent Change in Bone Mineral Density at 3 Years|Bone mineral density (BMD) was measured by DXA scan (Dual X-ray absorptiometry) for five locations: lumbar, right total hip, left total hip, right femoral neck, and left femoral neck. The percent change at 3 years was calculated for each location by the following formula: Percent Change BMD = (BMD_3 years – BMD_Baseline)/ BMD_Baseline * 100.|Baseline, 3 years from start of treatment|Eligible patients with baseline and 3-year BMD data at respective location|||percentage of baseline value||Full Range|Mean
1272938|NCT00329797|Primary|Freedom From Any Bone Fracture (FABF) Rate at Three Years|The time of failure was measured from the date of randomization to the date of documented bone fractures, defined as any fracture of the bone. The three-year FABF rate will be estimated by the Kaplan-Meier method.|From randomization to 3 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
1275130|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|12 weeks|Week 12 Data|||RMDQ Scale||Inter-Quartile Range|Median
1272941|NCT00329784|Secondary|Number of Participants With Rhinitis at 60 Months|At 60 months of age, participants were assessed for rhinitis. Two types of rhinitis were assessed, perennial rhinoconjunctivitis and seasonal rhinoconjunctivitis. Participants were considered to have either type of rhinitis if they showed a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced either when exposed to the relevant allergen (perennial) or during the relevant season (seasonal).|60 months|Intent-to-treat with rhinitis data available|||Participants|||Count of Participants
1272942|NCT00329784|Secondary|Number of Participants With Asthma at 60 Months|At 60 months of age, participants were assessed for asthma. Participants were considered to have asthma if they had a history of cough, wheeze, or shortness of breath that (1) was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, (2) required one visit to a physician in the previous 24 months, or (3) occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months.|60 months|Intent-to-treat with asthma data available|||Participants|||Count of Participants
1272943|NCT00329784|Secondary|SCORAD at 60 Months|At 60 months of age, participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD). This measure was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child’s eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.|60 months|Intent-to-treat with SCORAD data available|||units on a scale||Standard Deviation|Mean
1272944|NCT00329784|Primary|Number of Participants With Peanut Allergy at 60 Months of Age – Both Strata Combined|At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|60 months|Intent-to-treat – all randomly assigned participants who were evaluable for peanut allergy at age 60 months|||Participants|||Count of Participants
1272945|NCT00329784|Primary|Number of Participants With Peanut Allergy at 60 Months of Age – by Skin Prick Test Stratum|At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|60 months|Intent-to-treat – all randomly assigned participants who were evaluable for peanut allergy at age 60 months|||Participants|||Count of Participants
1272946|NCT00329771|Primary|Proportion of Subjects With Allodynia During a Migraine Attack|Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS).|allodynia assessed within 4 hours from onset of migraine head pain|Participants who completed allodynia test|||participants|||Number
1272947|NCT00329745|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the end of the primary study up to Year 3||||subjects|||Number
1272948|NCT00329745|Primary|Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|"Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample.~Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary."|From Year 2 up to Year 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy.|||subjects|||Number
1272949|NCT00329732|Secondary|Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;||30 minutes|||||||
1272950|NCT00329732|Secondary|Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.||30 minutes|||||||
1272951|NCT00329732|Secondary|Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;||30 minutes|||||||
1272952|NCT00329732|Primary|Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.||30 minutes|No analysis was done. Study was terminated.||||||
1272953|NCT00329719|Secondary|Progression-free Survival|Kaplan-Meier survival curves will be used to estimate progression-time distributions.|Time from study registration to date of disease progression or last follow-up, assessed up to 5 years||||months||95% Confidence Interval|Median
1282693|NCT00240227|Primary|Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session|Study was terminated early. No final analyses completed.||||||
1272956|NCT00329719|Primary|Progression-free Survival|"The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation.~If more than 41 evaluable patients are accrued in group 1 or group 3, the additional patients will not be used to evaluate the decision rule for that group or otherwise used in any decision-making processes. However, they will be included in the final point and confidence interval estimates for that group.~The ‘success’ probability, i.e., 6-month progression-free survival percentage, for each of group 1 and group 3 will be estimated as the number of evaluable patients still alive at 6 months divided by the total number of evaluable patients followed for at least 6 months. Ninety-five percent confidence intervals for the ‘success’ probability will be calculated according to the approach of Duffy and Santner.~Progression is defined as a 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|At 6 months||||Proportion of Successes||95% Confidence Interval|Number
1272957|NCT00329641|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 3 weeks)|Eligible patients who started therapy|||Participants with a given type of AE|||Number
1272958|NCT00329641|Secondary|6-month Progression-free Survival|Measured from the date of registration to the first of progression or death due to any cause with patients last known to be alive and progression-free censored at the date of last contact|Every 6 weeks for the first 8 cycles of therapy, and then every 9 weeks until disease progression for up to 3 years after registration or until death||||Percent of population||95% Confidence Interval|Number
1272959|NCT00329641|Secondary|One-year Overall Survival|Measured from date of registration to study until death due to any caused with observations last known to be alive censored at the date of last contact|Every 6-9 weeks until progression, after progression every six months for first two years and annually thereafter up to 3 for up to 3 years after registration or until death|Eligible patients who received some treatment|||Percentage of population||95% Confidence Interval|Number
1272960|NCT00329641|Primary|Response Rate (Complete and Partial Response)|Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.|Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression|Eligible patients who received some treatment|||participants|||Number
1272961|NCT00329602|Post-Hoc|Post-hoc Analysis of Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 12 and 26, Exploring the Impact of Center Group on Treatment Effect|A post-hoc analysis of CGI-I, exploring the variation in treatment effects across center groups by excluding the same two center groups as in the IRLS post-hoc analysis, was conducted. Centers were grouped into five center groups.|Weeks 12 and 26|ITT Population excluding the same two center groups as in the IRLS post-hoc analysis. Analysis is based on the observed cases for each visit.|||Number of responders|||Number
1272962|NCT00329602|Post-Hoc|Post-hoc Analysis of Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26, Exploring the Impact of Center Group on Treatment Effect|A post-hoc analysis of the primary outcome measure, exploring the variation in treatment effects across center groups by excluding those with the most extreme treatment effects, was conducted. Centers were grouped into five center groups.|Baseline and Weeks 12 and 26|ITT Population excluding the two center groups with the most extreme treatment effects. Analysis is based on the observed cases for each visit.|||Points on a scale||Standard Error|Least Squares Mean
1272963|NCT00329602|Secondary|Mean Change From Baseline in the IRLS Rating Scale Total Score at Week 67|A 10-item, participant-reported scale covering different symptoms of the condition. Each item is scored from 0 to 4, with 0 representing the absence of a problem and 4 reflecting a very severe problem. The best and worst possible scores are 0 and 40, respectively. The primary assessment was made by calculating the difference in the average score obtained at Baseline with score at Week 67.|Baseline and Week 67|Open-Label ITT Population: all participants who were enrolled into the Open-Label Phase of the study, received at least one dose of Open-Label study medication, and had a baseline IRLS total score and on-treatment IRLS assessment. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Deviation|Mean
1272964|NCT00329602|Primary|Number of Participants With Clinically Meaningful Augmentation and Early Morning Rebound (EMR) Cases|Clinically meaningful augmentation and early morning rebound (EMR) were assessed and confirmed by an independent Adjudication Board. EMR describes the development of RLS symptoms during the early morning, following therapeutic intervention. EMR is differentiated from augmentation, in which the earlier onset of symptoms occurs in the evening.|During 15-month study duration at scheduled (Weeks 16, 20, 26, or early withdrawal for DB phase; Weeks 39, 47, 55, 63, 67, or early withdrawal for the OL phase) and unscheduled (26-week DB phase and 40-week OL phase) visits|Safety Population: all participants who received at least one dose of study medication|||participants|||Number
1272965|NCT00329602|Secondary|Number of Participants With a Score of Much/Very Much Improved on the CGI-I Scale at Week 67|The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Week 67|Open-Label (OL) ITT Population: all participants who were enrolled into the OL Phase of the study, received at least one dose of OL study medication, and had a baseline IRLS total score and on-treatment IRLS assessment. Data are presented for participants still in the study and assessed at Week 26, which is less than those randomized at baseline.|||participants|||Number
1272991|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)||Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1272966|NCT00329602|Secondary|Median Time to First CGI-I Response of Much/Very Much Improved During the Double-blind Phase|The median time to first CGI-I response of much/very much improved was calculated. The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Baseline to Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available|||days||95% Confidence Interval|Median
1272967|NCT00329602|Secondary|Number of Participants Rated as Normal or Borderline Ill on the CGI Severity of Illness (CGI-S) Scale at Week 26|The CGI-S scale is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-S allows the investigator to rate the severity of the participant's illness considering their total clinical experience with the subject population being studied and on all information available at the time of rating. The scale is rated from 1-7 (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severly ill; 7 = among the most extremely ill participants).|Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Data are presented for the participants still in the study and assessed at Week 26, which is less than those randomised at baseline.|||participants|||Number
1272968|NCT00329602|Secondary|Number of Participants Withdrawing Due to Lack of Efficacy During the First 26 Weeks of the Study|Lack of efficacy is defined as up to a 10% improvement in the IRLS Rating Scale total score from the participant's Baseline value and at least 12 weeks of treatment during the double-blind phase.|Baseline to Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available|||participants|||Number
1272969|NCT00329602|Secondary|Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 1, 12 and 26|The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Weeks 1, 12 and 26|Intention-to-Treat (ITT) Population. Analysis is based on the observed cases for each visit.|||percentage of participants|||Number
1272970|NCT00329602|Secondary|Change From Baseline in the Domains of the MOS 36-item Short Form Health Survey (SF-36) at Weeks 12 and 26|The MOS SF-36 is a generic QoL instrument measuring functional status and well-being. Positive change from baseline for all domains indicates improvement. For all MOS SF-36 domains, the minimum and maximum scores are 0 and 100, respectively, for the transformed scale. Scores were adjusted for baseline domain score, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
1272971|NCT00329602|Secondary|Change From Baseline in the Johns Hopkins RLS Quality of Life (RLS QoL) Questionnaire Overall Life Impact Score at Weeks 12 and 26|The Johns Hopkins RLS QoL Questionnaire is a disease-specific instrument that assesses the impact of RLS on the daily life, emotional well-being, social life, and work life of participants. The overall life impact score for the John Hopkins RLS QoL scale ranges from a lowest possible score of 0 to a highest possible score of 100. Higher scores represent better quality of life. Scores were adjusted for baseline RLS Quality of Life score, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
1272972|NCT00329602|Secondary|Change From Baseline in Sleep Quantity, a Domain of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale, at Weeks 12 and 26|The MOS-12 Sleep Scale is a comprehensive battery, which measures specific aspects of sleep in participants that may have varying co-morbidities, and, as a result, is appropriate for a medically diverse participant population.Scores were adjusted for baseline MOS sleep scale domain value, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||hours||Standard Error|Least Squares Mean
1272973|NCT00329602|Secondary|Change From Baseline in the Domains of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale at Weeks 12 and 26|The MOS-12 Sleep Scale is a comprehensive battery, which measures specific aspects of sleep in participants that may have varying co-morbidities, and, as a result, is appropriate for a medically diverse participant population. Domain values are presented on a 0-100 scale, where a higher score means a greater degree of the attribute implied by the scale name. Scores were adjusted for baseline MOS sleep scale domain value, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
1272992|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 26||Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1282694|NCT00240162|Secondary|Disease Free Survival||Until the patient expires|This secondary outcome was not analyzed.||||||
1272974|NCT00329602|Secondary|Mean Change From Baseline in the International RLS (IRLS) Rating Scale Total Score at Weeks 1, 4, 8, 16, and 20|A 10-item, participant-reported scale covering different RLS symptoms. Each item is scored from 0 to 4; 0 represents the absence of a problem and 4 reflects a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. The primary assessment from this study was made by calculating the difference in the average score obtained at Baseline with scores at Weeks 1, 4, 8, 16, and 20. Scores were adjusted for baseline IRLS total score, treatment group, visit, visit by treatment group interaction, and center group.|Baseline and Weeks 1, 4, 8, 16, and 20|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
1272975|NCT00329602|Primary|Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26|A 10-item, participant-reported scale covering different symptoms of the condition. Each item is scored from 0 to 4; 0 represents the absence of a problem and 4 reflects a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. A negative change from baseline indicates improvement, and a negative treatment difference indicates a benefit of Ropinirole IR over placebo. The primary assessment was made by calculating the difference in the average score obtained at Baseline with scores at Week 12 and then Week 26.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
1272976|NCT00329550|Post-Hoc|Number of Subjects With Disease Progression|"Disease progression is defined as:~an increase from Week 6 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,~use of rescue therapy, or,~subject withdrawal from the study."|Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87047 (NCT00329550). As it was not possible to calculate the time to disease progression (outcome measure 22) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here.|||subjects|||Number
1272977|NCT00329550|Secondary|Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1272978|NCT00329550|Secondary|Percentage of Subjects at Week 26 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1272979|NCT00329550|Secondary|Percentage of Subjects at Week 24 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1272980|NCT00329550|Secondary|Percentage of Subjects at Week 20 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1272993|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 24||Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1272981|NCT00329550|Secondary|Percentage of Subjects at Week 16 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1272982|NCT00329550|Secondary|Percentage of Subjects at Week 12 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1272983|NCT00329550|Secondary|Percentage of Subjects at Week 8 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1272984|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0||Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1272985|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0||Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1272986|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0||Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1272987|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0||Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1272988|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0||Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1272989|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0||Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1272990|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0||Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||ratio||Full Range|Geometric Mean
1273528|NCT00326898|Other Pre-specified|The Association Between Angiogenesis Markers and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
1272994|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 20||Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1272995|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 16||Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1272996|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 12||Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1272997|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 8||Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||mg/L||Full Range|Geometric Mean
1272998|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 0||Week 0 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1272999|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273000|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273001|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273002|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273003|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273557|NCT00326716|Primary|Mean RTV Area Under the Concentration Curve (AUC TAU)|AUC = area under the concentration curve (AUC [TAU]) of ritonavir in one dosing interval.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||ng•h / mL||95% Confidence Interval|Geometric Mean
1273004|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273005|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
1273006|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273007|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273008|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273009|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273010|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273011|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273081|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273012|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
1273013|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273014|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273015|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273016|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273017|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273018|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273019|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
1273082|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273020|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273021|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273022|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273023|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273024|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273025|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273026|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
1273027|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273095|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 8||Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273028|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273029|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273030|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273031|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273032|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273033|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
1273034|NCT00329550|Secondary|Time to Disease Progression|"Time to disease progression is defined as the earliest of:~time to an increase from Week 6 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,~time to use of rescue therapy, or,~time to subject withdrawal from the study."|Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87047 (NCT00329550). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see post-hoc outcome measure 80 where the number of subjects with disease progression is presented.||||||
1273035|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273036|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 26|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273037|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 24|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273038|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 20|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273039|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 16|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273040|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 12|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273041|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 8|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273042|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1273043|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1273044|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1273199|NCT00329238|Secondary|Composite of Recurrent VTE or All Cause Death at 18 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.|18 months|FAS|||Participants|||Number
1273045|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1273046|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1273047|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1273048|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273049|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 26|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273050|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 24|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273051|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273052|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 16|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1282754|NCT00239226|Secondary|Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups||January 2009|||||||
1273053|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 12|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273054|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 8|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
1273055|NCT00329550|Primary|Percentage of Crohn’s Disease Activity Index (CDAI) Responders at Week 26|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
1273056|NCT00329524|Secondary|Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx|Rating of tinnitus loudness using a scale of 0-100 for|immediately following active and sham TMS||||analog rating||Standard Deviation|Mean
1273057|NCT00329524|Secondary|Psychomotor Vigilance|Change in simple auditory reaction time after treatment|Immediately after treatment|per protocol|||milliseconds||Standard Deviation|Mean
1273058|NCT00329524|Primary|Change in PET Asymmetry Index|Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx|After active treatment week||||ratio||Standard Deviation|Mean
1273059|NCT00329433|Secondary|The Incidence of Bleeding in Each Group.||Up to 30 days after surgery|||||||
1273060|NCT00329433|Secondary|The Incidence of DVTs in Each Group.||7 days after surgery|||||||
1273061|NCT00329433|Primary|The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.|Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.|30 days after surgery|Intent-to-treat analysis was performed according to initial group assignment.|||participants|||Number
1273062|NCT00329420|Post-Hoc|Number of Subjects With Disease Progression|"Disease progression is defined as:~an increase from Week 14 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,~use of rescue therapy, or,~subject withdrawal from the study."|Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87048 (NCT00329420). As it was not possible to calculate the time to disease progression (outcome measure 34) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here|||subjects|||Number
1273063|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273064|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1274797|NCT00317941|Primary|Mean Scores of Reaction After Injection Reported by Participants|Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis|Up to 3 months assessed every 24 and 48 hours after injection||||Scores on a scale|Participants|Standard Deviation|Mean
1273065|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273066|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273067|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273068|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273069|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273070|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273071|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273096|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 0||Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273072|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273073|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
1273074|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273075|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273076|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273077|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273078|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273079|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273080|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273642|NCT00325819|Primary|Fever >=38C Within 32 Hours of Vaccination.|Fever, defined as rectal temperature >=38C within 32 hours of vaccination.|Fever within 32 hours following vaccination|Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group.|||percentage of participants|||Number
1273083|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273084|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
1273085|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)||Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273086|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 34||Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273087|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 32||Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273088|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 28||Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273089|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 24||Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273090|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 20||Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273091|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 16||Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273092|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 14||Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273093|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 12||Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273094|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 10||Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
1273097|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273098|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273099|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273100|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273101|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273102|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273103|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273104|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273105|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273106|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273107|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273108|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273109|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273110|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273111|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273112|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273113|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273200|NCT00329238|Secondary|Composite of Recurrent VTE or All Cause Death at 36 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.|36 months|FAS|||Participants|||Number
1273643|NCT00325780|Secondary|Change From Baseline in Total Cholesterol|Mean percent change from baseline in total cholesterol|Baseline to 52 weeks|Patients who had an observation at Week 52|||percent change||Standard Deviation|Mean
1273114|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273115|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273116|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273117|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273118|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273119|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273120|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273121|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273201|NCT00329238|Primary|Composite of Recurrent VTE or VTE Death at 18 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.|18 months|FAS|||Participants|||Number
1273644|NCT00325780|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)|Baseline to 52 Weeks|Patients who had an observation at Week 52|||percent change||Standard Deviation|Mean
1273122|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273123|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273124|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273125|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273126|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273127|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273128|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273129|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273139|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273130|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273131|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273132|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273133|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273134|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273135|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273136|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273137|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273138|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273140|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273141|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273142|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273143|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273144|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273145|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273146|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273147|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273148|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273149|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273150|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273151|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
1273152|NCT00329420|Secondary|Time to Disease Progression|"Time to disease progression is defined as the earliest of:~time to an increase from Week 14 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,~time to use of rescue therapy, or,~time to subject withdrawal from the study."|Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see outcome measure 124 where the number of subjects with disease progression is presented.||||||
1273153|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273154|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 34|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273155|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 32|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273156|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 28|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273157|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 24|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273158|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 20|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273159|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 16|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273160|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 14|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273161|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 12|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273162|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 10|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273163|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 8|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
1273164|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273165|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273191|NCT00329238|Secondary|Deaths of All Causes at 18 Months|Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.|18 months|FAS|||Participants|||Number
1273166|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273167|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273168|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273169|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273170|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273171|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273172|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273192|NCT00329238|Secondary|Deaths of All Causes at 36 Months|Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.|36 months|FAS|||Participants|||Number
1273193|NCT00329238|Secondary|Deaths Related to VTE at 18 Months|Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.|18 months|FAS|||Participants|||Number
1273173|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
1273174|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273175|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273176|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273177|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273178|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273179|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273180|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273194|NCT00329238|Secondary|Deaths Related to VTE at 36 Months|Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.|36 months|FAS|||Participants|||Number
1273181|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273182|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273183|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273184|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
1273185|NCT00329420|Primary|Percentage of Crohn’s Disease Activity Index (CDAI) Responders at Week 34|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of main study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). This summary is based on the 26 subjects in the Full Analysis Set (FAS) Population who responded to re-induction at Week 14. Subject withdrawal or use of rescue therapy is counted as non-response from that time onwards in that study.|||Percentage of subjects|||Number
1273186|NCT00329407|Secondary|Phonetic Portion of the Controlled Word Association Test (COWAT)|Phonetic COWAT is a measure of verbal fluency. Results are in terms of number of words produced starting with a set of particular letters.This involves a comparison of baseline and Week 10 COWAT scores|Baseline compared to Week 10||||Number of words||Standard Error|Mean
1273187|NCT00329407|Primary|The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method|The primary outcome was the mean daily consumption of standard alcoholic drinks (14 g per ethanol) during the baseline week compared to week 10, the final week subjects were one maintenance dose of topirmate.|70 days|An ITT approach was used in the analysis. Least squares value for the baseline and 10 week of treatment were compared using a t test with Dunnett-Hsu adjustment. Differences between these means are presented as the result.|||Standard Drink (14 g alcohol)||Standard Error|Mean
1273188|NCT00329238|Secondary|Number of Participants With Definite Acute Coronary Syndrome (ACS)|All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.|day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination|FAS as treated|||participants|||Number
1273189|NCT00329238|Secondary|Laboratory Analysis|Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).|18 months + 30 days follow up|FAS as treated|||participants|||Number
1273190|NCT00329238|Secondary|Number of Participants With Bleeding Events|"MBE (major bleeding event) if it fulfilled at least one of the following criteria~Fatal bleeding~Symptomatic bleeding in a critical area or organ.~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.~Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs~CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria~Spontaneous skin haematoma ≥25 cm2~Spontaneous nose bleed >5 min duration~Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h~Spontaneous rectal bleeding~Gingival bleeding >5 min~Bleeding leading to hospitalisation or requiring surgical treatment~Bleeding leading to a transfusion of <2 units of whole blood or red cells~Any other bleeding event considered clinically relevant by the investigator"|first intake of study drug until 6 days following last intake of study drug|FAS as treated|||participants|||Number
1273202|NCT00329238|Primary|Composite of Recurrent VTE or VTE Death at 36 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.|36 months|FAS|||Participants|||Number
1273203|NCT00329160|Secondary|Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points||Baseline - 76Weeks||||Percent change||Standard Deviation|Mean
1273204|NCT00329160|Secondary|Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）||Baseline - 76Weeks||||Percent change||Standard Deviation|Mean
1273205|NCT00329160|Secondary|Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion|Target Lesion indicates Coronary plaque composition of culprit lesions.|Baseline - 76Weeks||||mg/dL||Standard Deviation|Mean
1273206|NCT00329160|Primary|Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)|Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.|Baseline and 76 weeks||||Percent Change||Standard Deviation|Mean
1273207|NCT00329108|Secondary|Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.||6 months|||||||
1273208|NCT00329108|Secondary|Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.||6 weeks|||||||
1273209|NCT00329108|Secondary|Time to Symptomatic Remission in the Double Blind Phase.||up to 10 weeks|||||||
1273210|NCT00329108|Secondary|Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.||4, 6 and 10 weeks|||||||
1273211|NCT00329108|Secondary|Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.||6 months|||||||
1273212|NCT00329108|Secondary|Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.||up to 10 weeks|||||||
1273213|NCT00329108|Primary|Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.|YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.|4 weeks|Study was terminated due to poor recruitment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||score on scale|||Number
1273214|NCT00329030|Secondary|Neutrophil Recovery|Time to neutrophil recovery will be the first of two consecutive days of > 500 neutrophils/μL following the expected nadir.|Day 28 and Day 60||||percentage of participants||95% Confidence Interval|Number
1273215|NCT00329030|Secondary|Treatment-related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression|1 and 2 years||||percentage of participants||95% Confidence Interval|Number
1273216|NCT00329030|Secondary|Immune Reconstitution of Quantitative Immunoglobulins|Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.|1 year||||mg/dL||Standard Deviation|Mean
1273217|NCT00329030|Secondary|Immune Reconstitution|Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.|1 year||||cells/uL||Standard Deviation|Mean
1273218|NCT00329030|Secondary|Mucositis Severity|Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.|Day 21||||scores on a scale||Full Range|Median
1273219|NCT00329030|Secondary|Incidence of Infection||1 year|67 patients treated with B-BEAM incurred a total of 139 infections. 60 patients treated with R-BEAM incurred a total of 121 infections.|||participants|||Number
1273220|NCT00329030|Secondary|Hematologic Function|Hematologic function will be defined as ANC > 1,500 neutrophils/μL, hemoglobin > 10 g/dL without transfusion support, and platelet count > 100,000/μL without transfusion support.|100 days, 1 year||||percentage of participants||95% Confidence Interval|Number
1273221|NCT00329030|Secondary|Platelet Recovery to 20,000 Cells/μL||100 and 180 days||||percentage of participants||95% Confidence Interval|Number
1273222|NCT00329030|Secondary|Complete Response (CR) and Partial Response (PR) Proportion||Day 100 and 2 years||||percentage of participants||95% Confidence Interval|Number
1273223|NCT00329030|Secondary|Incidence of Relapse/Progression|The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.|1 and 2 years||||percentage of participants||95% Confidence Interval|Number
1273224|NCT00329030|Secondary|Overall Survival|The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation|1 and 2 years||||percentage of participants||95% Confidence Interval|Number
1273225|NCT00329030|Primary|Progression-free Survival (PFS)|Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.|1 and 2 years||||percentage of participants||95% Confidence Interval|Number
1273226|NCT00328926|Secondary|Percentage of Participants With Cumulative Ovulation|Ovulation was defined as a mid-luteal phase progesterone (P4) level greater than or equal to (>=) 10 nanogram per milliliter (ng/mL). Cumulative ovulation referred to all ovulations that occurred during all the 3 treatment cycles.|Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days])|ITT population included all participants who were treated to trial treatment.|||Percentage of participants|||Number
1273227|NCT00328926|Secondary|Percentage of Participants With Cumulative Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. Cumulative clinical pregnancy referred to all clinical pregnancy that occurred during all the 3 treatment cycles.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])|ITT population included all the participants who received study treatment.|||Percentage of participants|||Number
1273228|NCT00328926|Primary|Time to Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Stimulation Day 1 up to clinical pregnancy (Day 35-42 post r-hCG administration day [end of stimulation cycle {approximately 21 days}])|Intention-to-treat (ITT) population included all the participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Days||Full Range|Median
1273229|NCT00328861|Secondary|Safety|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|11/30/2006 - 7/31/2007||||Participants|||Number
1273230|NCT00328861|Primary|Objective Response|Objective response (complete response (CR) or partial response (PR)) is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|very 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.||||Participants|||Number
1273231|NCT00328783|Secondary|Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.|To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.|30 days post-treatment||||Participants|||Count of Participants
1273232|NCT00328783|Secondary|Change in Organs at Risk (OAR) Dosimetric Paramaters|To evaluate the magnitude of change in Mean Heart Dose (MHD) and Left lung dose when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.|30 days post-treatment||||Gy||95% Confidence Interval|Mean
1273233|NCT00328783|Secondary|Toxicity Evaluation|Number of participants that experienced grade three toxicity or higher as a result of treatment.|30 days post-treatment||||Participants|||Count of Participants
1273234|NCT00328783|Primary|Proportion of Patients With Reduction in Radiation||30 days||||proportion of patients||95% Confidence Interval|Number
1273235|NCT00328783|Primary|Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues|"To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.~The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose."|At time of radiation||||Gy||95% Confidence Interval|Mean
1273236|NCT00328770|Secondary|Sirolimus Toxicity/Intolerance|Sirolimus toxicity/intolerance requiring discontinuation of sirolimus|1 year||||participants|||Number
1273237|NCT00328770|Primary|Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant|Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant|1 and 4 years||||percentage of participants|||Number
1273238|NCT00328770|Primary|Percentage of Participants Surviving at One and Four Years After Liver Transplant|Percent of Patients Surviving at One & Four years after Liver Transplant was calculated|1 & 4 years|Percentage of patients surviving to 1 and 4 years after liver transplant was calculated for all patients|||percentage of participants|||Number
1273239|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean HDL Particle Size|The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273240|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean HDL Particle Size|The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273241|NCT00328627|Secondary|Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273242|NCT00328627|Secondary|Change From Baseline to Week 26 in HDL Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μmol/L||Standard Error|Least Squares Mean
1273243|NCT00328627|Secondary|Change From Baseline to Week 12 in HDL Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μmol/L||Standard Error|Least Squares Mean
1273244|NCT00328627|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μMOL/L||Standard Error|Least Squares Mean
1273245|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean LDL Particle Size|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273246|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean LDL Particle Size|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273247|NCT00328627|Secondary|Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273248|NCT00328627|Secondary|Change From Baseline to Week 26 in LDL Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273249|NCT00328627|Secondary|Change From Baseline to Week 12 in LDL Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273250|NCT00328627|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273251|NCT00328627|Secondary|Change From Baseline to Week 26 in IDL Particles|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273252|NCT00328627|Secondary|Change From Baseline to Week 12 in IDL Particles|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273253|NCT00328627|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273254|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean VLDL Particle Size|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273255|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean VLDL Particle Size|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273256|NCT00328627|Secondary|Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
1273257|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates"|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273258|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273259|NCT00328627|Secondary|Change From Baseline in VLDL Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273260|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides|The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273261|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides|The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273262|NCT00328627|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273263|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273264|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273265|NCT00328627|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
1273266|NCT00328627|Secondary|Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides|"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273267|NCT00328627|Secondary|Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides|"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273268|NCT00328627|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)|"Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273269|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein C-III|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273270|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein C-III|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273271|NCT00328627|Secondary|Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)|Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273272|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein B|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273273|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein B|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273274|NCT00328627|Secondary|Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273275|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein A2|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273276|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein A2|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273277|NCT00328627|Secondary|Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273278|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein A1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273279|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein A1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273280|NCT00328627|Secondary|Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273281|NCT00328627|Secondary|Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
1273282|NCT00328627|Secondary|Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
1273283|NCT00328627|Secondary|Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)|"The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B).~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
1273284|NCT00328627|Secondary|Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
1273285|NCT00328627|Secondary|Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
1273286|NCT00328627|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)|"HOMA IR measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.~Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
1273287|NCT00328627|Secondary|Change From Baseline to Week 26 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
1273288|NCT00328627|Secondary|Change From Baseline to Week 20 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
1273289|NCT00328627|Secondary|Change From Baseline to Week 12 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
1273290|NCT00328627|Secondary|Change From Baseline to Week 8 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
1273291|NCT00328627|Secondary|Change From Baseline in Body Weight Over Time (Grouped Analysis)|Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Weeks 8, 12, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
1273292|NCT00328627|Secondary|Change From Baseline to Week 26 in Adiponectin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
1273293|NCT00328627|Secondary|Change From Baseline to Week 12 in Adiponectin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
1273294|NCT00328627|Secondary|Change From Baseline in Adiponectin Over Time (Grouped Analysis)|Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
1273295|NCT00328627|Secondary|Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
1273296|NCT00328627|Secondary|Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
1273297|NCT00328627|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)|"Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
1273298|NCT00328627|Secondary|Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273299|NCT00328627|Secondary|Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273313|NCT00328627|Secondary|Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273300|NCT00328627|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)|"Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273301|NCT00328627|Secondary|Change From Baseline to Week 26 in Free Fatty Acids|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
1273302|NCT00328627|Secondary|Change From Baseline to Week 12 in Free Fatty Acids|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
1273303|NCT00328627|Secondary|Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)|Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
1273304|NCT00328627|Secondary|Change From Baseline to Week 26 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273305|NCT00328627|Secondary|Change From Baseline to Week 20 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273306|NCT00328627|Secondary|Change From Baseline to Week 16 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273307|NCT00328627|Secondary|Change From Baseline to Week 12 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273308|NCT00328627|Secondary|Change From Baseline to Week 8 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273309|NCT00328627|Secondary|Change From Baseline to Week 4 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273310|NCT00328627|Secondary|Change From Baseline in Triglycerides Over Time (Grouped Analysis)|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273311|NCT00328627|Secondary|Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273312|NCT00328627|Secondary|Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273737|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||mMU/mL||95% Confidence Interval|Geometric Mean
1273314|NCT00328627|Secondary|Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273315|NCT00328627|Secondary|Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273316|NCT00328627|Secondary|Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273317|NCT00328627|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)|"Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273318|NCT00328627|Secondary|Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273319|NCT00328627|Secondary|Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273320|NCT00328627|Secondary|Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273321|NCT00328627|Secondary|Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273322|NCT00328627|Secondary|Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273323|NCT00328627|Secondary|Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273324|NCT00328627|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)|"Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273325|NCT00328627|Secondary|Change From Baseline to Week 26 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273326|NCT00328627|Secondary|Change From Baseline to Week 20 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273558|NCT00326716|Primary|Mean ATV Area Under the Concentration Curve (AUC TAU)|AUC = area under the concentration curve (AUC [TAU]) of atazanavir in one dosing interval from time zero to 24 hours.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||ng•h / mL||95% Confidence Interval|Geometric Mean
1273327|NCT00328627|Secondary|Change From Baseline to Week 16 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273328|NCT00328627|Secondary|Change From Baseline to Week 12 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273329|NCT00328627|Secondary|Change From Baseline to Week 8 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273330|NCT00328627|Secondary|Change From Baseline to Week 4 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273331|NCT00328627|Secondary|Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)|Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273332|NCT00328627|Secondary|Change From Baseline to Week 26 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273333|NCT00328627|Secondary|Change From Baseline to Week 20 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273334|NCT00328627|Secondary|Change From Baseline to Week 16 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273335|NCT00328627|Secondary|Change From Baseline to Week 12 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273336|NCT00328627|Secondary|Change From Baseline to Week 8 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273337|NCT00328627|Secondary|Change From Baseline to Week 4 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273338|NCT00328627|Secondary|Change From Baseline in C-peptide Over Time (Grouped Analysis)|"C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
1273339|NCT00328627|Secondary|Change From Baseline to Week 26 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1273353|NCT00328627|Secondary|Change From Baseline to Week 26 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1273340|NCT00328627|Secondary|Change From Baseline to Week 20 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1273341|NCT00328627|Secondary|Change From Baseline to Week 16 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1273342|NCT00328627|Secondary|Change From Baseline to Week 12 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1273343|NCT00328627|Secondary|Change From Baseline to Week 8 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1273344|NCT00328627|Secondary|Change From Baseline to Week 4 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1273345|NCT00328627|Secondary|Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
1273346|NCT00328627|Secondary|Change From Baseline to Week 26 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
1273347|NCT00328627|Secondary|Change From Baseline to Week 20 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
1273348|NCT00328627|Secondary|Change From Baseline to Week 16 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
1273349|NCT00328627|Secondary|Change From Baseline to Week 12 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
1273350|NCT00328627|Secondary|Change From Baseline to Week 8 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
1273351|NCT00328627|Secondary|Change From Baseline to Week 4 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
1273352|NCT00328627|Secondary|Change From Baseline in Insulin Over Time (Grouped Analysis)|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
1273354|NCT00328627|Secondary|Change From Baseline to Week 20 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1273355|NCT00328627|Secondary|Change From Baseline to Week 16 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1273356|NCT00328627|Secondary|Change From Baseline to Week 12 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1273357|NCT00328627|Secondary|Change From Baseline to Week 8 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1273358|NCT00328627|Secondary|Change From Baseline to Week 4 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1273359|NCT00328627|Secondary|Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)|"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
1273360|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273361|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26.|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273362|NCT00328627|Primary|Change From Baseline to Week 26 in HbA1c|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1273363|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273364|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273365|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273366|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273408|NCT00328198|Secondary|Kaplan-Meier Estimates of Overall Survival|Overall survival was defined as the time in days from the date of first treatment to the date of death due to any cause for all participants. Results are stated in months.|up to 5 years|Full analysis set|||months||95% Confidence Interval|Median
1273367|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273368|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273369|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273370|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273371|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273372|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273373|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273374|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1273375|NCT00328627|Secondary|Percentage of Participants Meeting Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:~After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c."|From Week 1 to Week 26|Full analysis set including patients with at least 1 postbaseline visit.|||percentage of participants|||Number
1273376|NCT00328627|Secondary|Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:~After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c."|From Week 1 to Week 26.|Full analysis set including patients with at least 1 postbaseline visit. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.|||percentage of participants|||Number
1273377|NCT00328627|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).|From Week 1 to Week 26|Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group.|||percentage of participants|||Number
1273378|NCT00328627|Secondary|Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)|"Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|From Week 1 to Week 26|Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group.|||percentage of participants|||Number
1273379|NCT00328627|Secondary|Change From Baseline to Week 26 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273380|NCT00328627|Secondary|Change From Baseline to Week 20 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273381|NCT00328627|Secondary|Change From Baseline to Week 16 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273382|NCT00328627|Secondary|Change From Baseline to Week 12 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273383|NCT00328627|Secondary|Change From Baseline to Week 8 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273384|NCT00328627|Secondary|Change From Baseline to Week 4 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273385|NCT00328627|Secondary|Change From Baseline to Week 2 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 2|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273386|NCT00328627|Secondary|Change From Baseline to Week 1 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 1|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273387|NCT00328627|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)|"The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates."|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
1273388|NCT00328627|Secondary|Change From Baseline to Week 20 in HbA1c|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates."|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1273389|NCT00328627|Secondary|Change From Baseline to Week 16 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1273390|NCT00328627|Secondary|Change From Baseline to Week 12 in HbA1c|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1273391|NCT00328627|Secondary|Change From Baseline to Week 8 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1273392|NCT00328627|Secondary|Change From Baseline to Week 4 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1273393|NCT00328627|Secondary|Change From Baseline in HbA1c Over Time (Grouped Analysis)|"The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates."|Baseline and Weeks 4, 8, 12, 16 and 20.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1273394|NCT00328627|Primary|Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)|"The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).~The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone)."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1273395|NCT00328614|Primary|Maximum Tolerated Dose of Samarium-153|"To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT).~Dose levels:~Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV~Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose."|5 months (1 month HT, administration of drug, 4 months HT and RT)||||mCi/kg|||Number
1273396|NCT00328562|Secondary|Survival From Starting Gefitinib||Baseline to date of expiration||||months||Full Range|Median
1273397|NCT00328562|Secondary|Progression-free Survival||Baseline to date of progression||||months||Full Range|Median
1273398|NCT00328562|Secondary|Tumor Response|"Definitions of objective tumor response~Complete response - disappearance of all target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions~Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started"|Baseline, 1, 3, and 5 months post-treatment||||participants|||Number
1273399|NCT00328562|Primary|Patients Affected by Treatment-related Morbidities|"See Adverse Events section for specific toxicities"|Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy||||participants|||Number
1273400|NCT00328510|Primary|Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability|This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.|Measurements taken during SRT||||millimeters|Participants|Standard Deviation|Mean
1273401|NCT00328263|Secondary|Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics|Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1|Up to 40 days|||||||
1273402|NCT00328263|Secondary|Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients||Up to 40 days|||||||
1273403|NCT00328263|Secondary|Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.|Testing for CDAD was performed at the discretion of the treating physician and according to the protocol in place at the study centers. CDAD was defined as an episode of diarrhea and positive results for C. difficile Toxin A or B.|Up to 40 days|||||||
1273404|NCT00328263|Primary|The Incidence of Antibiotic-associated Diarrhea.|Presence of at least one diarrhea episode within 24 hours.|Up to 40 days||||participants|||Number
1273405|NCT00328198|Primary|Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.|up to 44 weeks|Full analysis set. 95% confidence interval calculated using exact binomial method.|||percentage of participants||95% Confidence Interval|Number
1273406|NCT00328198|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Number of participants with treatment-emergent adverse events (TEAEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (5 point scale from 'not related' to 'definitely related') and severity (5 point scale with grade 5 being most severe). Categories reported include participant counts for treatment-emergent AEs, injection site reactions, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), deaths and severity.|up to 18 weeks of treatment plus 45 days|Full analysis set|||participants|||Number
1273407|NCT00328198|Secondary|Participants With a Minimal Residual Disease (MRD) Status of Negative|MRD negativity represents a very positive response outcome. MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. All patients are evaluated for treatment response based on National Cancer Institute Working Group (NCIWG) criteria. Of patients who have achieved a clinical complete response (CR) or partial response (PR) that met National Cancer Institute Working Group (NCIWG) criteria of CR except blood recovery, a bone marrow sample was taken for flow cytometry measure of MRD negativity.|44 weeks|Full analysis set|||participants|||Number
1273409|NCT00328198|Secondary|Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)|"Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease (PD) as determined by IRRP or death due to any cause. Results are stated in months.~Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology."|up to 5 years|Participants who had a complete response or a partial response|||months||95% Confidence Interval|Median
1273410|NCT00328198|Secondary|Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)|"Progression-free survival was defined as the number of days from the date of first treatment to the date of first objective documentation of progressive disease (PD) as determined by the IRRP, or death due to any cause. Results are expressed in months.~Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology."|up to 5 years|Full analysis set|||months||95% Confidence Interval|Median
1273411|NCT00328198|Primary|Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.|up to 44 weeks|Full analysis set|||participants|||Number
1273412|NCT00328172|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks|An absolute efficacy response is defined as HbA1c <= 7.0% at 12 weeks. A non-response is defined as HbA1c > 7.0% at 12 weeks.|Baseline, week 12|FAS patients with baseline HbA1c > 7.0%. Non-completers were considered as failure imputation (NCF).|||participants|||Number
1273413|NCT00328172|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1273414|NCT00328172|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12|The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Least Squares Mean
1273415|NCT00328094|Primary|Composite (Myocardial Infarction and CHF)||hospital length of stay||||Number of patients|||Number
1273416|NCT00328094|Secondary|Incidence of Wound Infections||postoperative||||participants|||Number
1273417|NCT00328042|Secondary|Hepatitis C Knowledge Questionnaire|The measure consists of 15 questions covering Hepatitis C-specific information related to disease self-management. Each correct response is scored as one point, with total scores range from 0 to 15. Higher scores indicate higher levels of Hepatitis C-specific knowledge. There are no subscales.|Base Line, 6 weeks||||units on a scale||Standard Deviation|Mean
1273418|NCT00328042|Primary|Quality of Well-being Scale - Self-Administered (QWB-SA)|The QWB-SA is a preference-based measure of health-related quality of life. Scores range from 0 to 1.0, with 0 representing death, and 1.0 representing asymptomatic, optimal functioning. Thus, higher scores indicate higher quality of life.|Base Line, 12 months||||units on a scale||Standard Deviation|Mean
1273419|NCT00328016|Secondary|End Tidal CO2 (PetCO2)|End tidal CO2 was monitored continuously using a respiratory gas monitor|After 15 minutes of guided breathing or control task||||mmHg||Standard Error|Mean
1273420|NCT00328016|Secondary|Minute Ventilation|Minute Ventilation was continuously monitored via inductive plethysmography|After 15 minutes of guided breathing or control task||||L/min||Standard Error|Mean
1273421|NCT00328016|Primary|Breathing Rate|Breathing rate was monitored continuously via inductive plethysmography.|After 15 minutes of guided breathing or control task||||Breaths/minute||Standard Error|Mean
1273422|NCT00327717|Secondary|Drop - Out Rate|Number of Participants who dropped out of the study. In the Study drop-out rate is defined as number of participants.|16 weeks|FAS Population|||Number of Participants|||Number
1273423|NCT00327717|Secondary|Percentage of Seizure-free Participants During Fixed-dose Phase|Percentage of seizure-free participants during fixed-dose phase|16 weeks|FAS Population|||Percentage of Participants|||Number
1273424|NCT00327717|Secondary|Mean Time to First Seizure (Days)|Mean time to first seizure during fixed dose phase|16 weeks|FAS Population|||Days||Standard Deviation|Mean
1273425|NCT00327717|Secondary|Mean Percentage of Change in Seizure Free Days||16 weeks|FAS Population|||Percent Change||Standard Deviation|Mean
1273426|NCT00327717|Secondary|Mean Number of Seizure Free Days|Mean number of seizure free days per 28 day period during fixed dose phase|12 weeks|FAS Population|||Days||Standard Deviation|Mean
1273427|NCT00327717|Secondary|Responder Rate|Responder rate is defined as percentage of participants with >=50% reduction in seizure frequency from baseline.|Baseline and 16 weeks|FAS Population|||Percentage of Participants|||Number
1273428|NCT00327717|Secondary|The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)|The mean percent change in seizure frequency of SGS from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS Population. Secondary generalization patients|||Percent Change||Standard Deviation|Mean
1273429|NCT00327717|Secondary|The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency|The Mean percent change in seizure frequency of SP from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS Population. Simple partial seizure patients|||Percent Change||Standard Deviation|Mean
1273430|NCT00327717|Secondary|The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency|The Mean Percent Change in seizure frequency of CP from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS population. Complex partial seizure patients|||Percent Change||Standard Deviation|Mean
1273431|NCT00327717|Primary|Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase|The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.|Baseline and 16 weeks|Full analysis set (FAS)|||Percent Change||Full Range|Median
1273432|NCT00327470|Secondary|Mean Change in Euro QoL Questionnaire (EQ-5D) Score|The EQ-5D is a validated, standardized QoL instrument assessing general health status based on the preference of a UK general population. It consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute (“no problem”, “some problems” and “extreme problems”). A subject’s responses to these domains were mapped to a corresponding score of the EQ-5D index.|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Scores on a scale||Standard Deviation|Mean
1273433|NCT00327470|Secondary|Mean Change in National Eye Institute – Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score|Subject reported vision-related functioning and Quality of Life (QoL) as measured using the 25 item NEI-VFQ-25. Items are grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. A positive change represents an increase in function/health, a negative change represents a decrease in function/health.|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Scores on a scale||Standard Deviation|Mean
1273434|NCT00327470|Secondary|Mean Change From Baseline in Contrast Sensitivity|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline through Week 54, Baseline through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Correctly read letters||Standard Deviation|Mean
1273435|NCT00327470|Secondary|Mean Change in Reading Speed|For assessment of reading speed, subjects were asked to read a print steadily, without stopping or interruption, at a comfortable pace. On commencing reading, a timer was activated. The timer was stopped when the subject had finished reading all of the words on the chart or at 2 minutes, whichever was sooner. Only the total number of words read correctly was recorded. The time recorded for the reading speed test was the time required for the subject to finish reading all of the words on the chart in minutes and seconds (maximum 2 minutes).|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Correctly read words per minute||Standard Deviation|Mean
1273436|NCT00327470|Secondary|Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions|Near VA was measured with the modified Bailey-Lovie near-word reading charts at a distance of 25 centimeters using a +3.50 reading addition worn over the protocol refraction providing the best-corrected distance VA. The reading charts test the smallest word size identifiable from 0.0 logarithmic of the minimum angle of resolution (logMAR) to 1.6 logMAR. logMAR is the logarithm of the minimum angle of resolution. The ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values >0.00 indicate vision poorer than ideal and values <0.0 indicate vision greater than ideal.|Baseline through Week 54, Baseline through Week 102|MITT LOCF. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Scores on a scale||Standard Deviation|Mean
1273437|NCT00327470|Secondary|Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions|The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey ETDRS charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters, gaining >=0 or >=15 letters. The mean changes in VA from Baseline/Week 102 and Week 52/102 were assessed.|Baseline through Week 102, Week 54 through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.|||Scores on a scale||Standard Deviation|Mean
1273438|NCT00327470|Primary|Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions|The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters from Baseline, gaining >=0 or >=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.|Baseline through Week 54|The modified intent-to-treat (MITT) population included all subjects in the safety population who had a Baseline distance VA measurement and at least 1 post-Baseline VA measurement. Last observation carried forward (LOCF). Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.|||Scores on a scale||Standard Deviation|Mean
1273439|NCT00327444|Secondary|Plasma Levels of Free and VEGF-bound Aflibercept|"Free aflibercept and VEGF-bound aflibercept plasma concentrations were measured by separate enzyme-linked immunosorbent assay (ELISA). The limit of quantitation of free aflibercept was 15.6 ng/mL, and of VEGF-bound aflibercept was 43.9 ng/mL.~Peak free aflibercept was estimated at the end of Cycle 1 (C1) administration. The median free and VEGF-bound trough concentrations were determined for each participant beyond Cycle 3 (C3), then mean values were estimated from these median values."|Following every biweekly treatment administration up to 60 days after treatment discontinuation|The analysis was performed using the safety population with evaluable blood samples. 42 participants were evaluated.|||μg/mL||Standard Deviation|Mean
1273441|NCT00327444|Secondary|Area Under the Curve (AUC) for Participant Assessed Ascites Impact Measure (AIM)|"AIM 4 symptoms (abdominal discomfort, abdominal bloating, abdominal pain, and ability to move normally) are scored from 0 to 5, where higher scores represent worst outcomes. An AIM total score ranges from 0-20.~A plot for (The AIM questionnaire total score - Baseline score) versus time were generated. AIM AUC represents the overall improvement (scored positive) if the area is below the baseline value or worsening (scored negative) if the area is above the baseline. AIM AUC for a participant is the sum of individual areas representing improvement (+) or worsening (-)."|From Day 1 up to 60 days from randomization to the first postrandomization paracentesis|The intent-to-treat (ITT) population - all participants who were randomized in the study, and had evaluable AIM scores.|||(units on a 4-symptom scale)*day||Standard Error|Least Squares Mean
1273442|NCT00327444|Primary|Time to Repeat Paracentesis (TRP)|"TRP was defined as the number of days between the date of randomization and the date of the first post-randomization paracentesis.~For participants who did not undergo a postrandomization paracentesis on study, TRP was calculated from randomization to the end of the double-blind treatment period."|From Day 1 up to 6 months from randomization|The intent-to-treat (ITT) population - all participants who were randomized in the study.|||days||Standard Error|Least Squares Mean
1273443|NCT00327392|Primary|Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures||2 hours|Number of patients requiring specified types of airway assistance|||particpants|||Number
1273444|NCT00327340|Secondary|Relationship Between Changes in Serum Clusterin Levels and Change in Serum PSA Levels When OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone is Administered as Second Line Chemotherapy.|Serum clusterin samples were collected prior to receiving OGX-011 loading dose 1, prior to study treatment on Day 1 of each cycle, and at the end of treatment. PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit, and during off-treatment follow-up. PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart.|Enrollment until disease progression (up to 13 months)|All 69 subjects were included. Data are presented for the 20 subjects who achieved a 50% decline in PSA (6 subjects who received mitoxantrone and prednisone in combination with OGX-011 and 14 subjects who received docetaxel and prednisone in combination with OGX-011)|||percentage of participants|||Number
1273445|NCT00327340|Secondary|Feasibility of Treatment With OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second Line Chemotherapy Based on Time to Pain Progression|Time to pain progression was defined as the time (months) from the first dose of OGX-011 to the first documentation of pain or analgesic progression or initiation of palliative radiation therapy. Pain response was defined as either a decrease of at least two points on the 11-point Worst Pain Scale, without an increase in analgesic level, maintained for at least two consecutive measurements approximately three weeks apart –or– a decrease in analgesic level, without an increase in pain score, maintained for at least two consecutive measurements approximately three weeks apart.|Enrollment until pain progression (up to 21 months)|Subjects were evaluable for pain response if they had a baseline Worst Pain Score ≥ 2 or were on opioid analgesics at baseline.|||months||95% Confidence Interval|Number
1273446|NCT00327340|Secondary|Feasibility of Treatment With Custirsen (OGX-011) in Combination With Second-line Chemotherapy Based on Prostate Specific Antigen (PSA) Response|PSA or prostate specific antigen is a marker for prostate cancer. A PSA response was defined as a decrease in PSA values of ≥ 50% relative to baseline on two or more consecutive measurements that were 4-6 weeks apart.|PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit and during off-treatment follow up (up to 27 months)|"Subjects were evaluable for PSA response if they had baseline PSA and at least two post baseline PSA values.~One subject was not evaluable for PSA response; he had only one post baseline PSA value. A PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart."|||percentage of participants||95% Confidence Interval|Number
1273447|NCT00327340|Primary|Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.|"Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE).~The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE."|Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment)|The total analysis population was 69 subjects: 70 subjects were enrolled; 45 were randomly assigned to treatment (24 to OGX-011/mitoxantrone and 21 to OGX-011 /docetaxel). An additional 25 subjects were assigned to OGX-011/docetaxel. One subject in the mitoxantrone arm was ineligible and did not receive study treatment.|||percentage of participants|||Number
1273448|NCT00327171|Secondary|Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire|The FACT-O questionnaire consists of 38 scored questions (scored from 0-4) that address physical well-being, social/family well-being, emotional well-being, functional well-being and some additional concerns which relate specifically to ovarian cancer symptoms. For each question, higher scores reflect a better quality of life. The total FACT-O score ranges from 0-152, with 152 indicating the best outcome.|On Day 1 of Cycle 1 (baseline) , and after Day 14 of Cycle 2|All randomized participants who had evaluable FACT-O questionnaires.|||score on a scale||Standard Deviation|Mean
1273449|NCT00327171|Secondary|Overall Safety - Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 30+/-5 days after treatment discontinuation, or up to recovery or stabilization of a followed-up adverse event|Safety population: All randomized participants who received at least part of one dose of study treatment.|||participants|||Number
1274814|NCT00317473|Secondary|Anti-FMP1 Antibody Titer Responses|Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine|364 days||||titers||95% Confidence Interval|Geometric Mean
1273450|NCT00327171|Primary|Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population|"OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference.~Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||participants|||Number
1273451|NCT00327171|Secondary|Overall Survival (OS) Time|"OS was the time interval between randomization and the date of death from any cause. OS was estimated using Kaplan-Meier curves~A participant was censored for the OS analysis if the participant were alive during the study. The censoring date was either at the date that the participant was last known to be alive or the date of study cut-off, whichever was earlier."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||weeks|Participants|95% Confidence Interval|Median
1273452|NCT00327171|Secondary|Progression-free Survival (PFS) Time Based on Analysis by the IRC|"PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. PFS was estimated using Kaplan-Meier curves.~For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||weeks|Participants|95% Confidence Interval|Median
1273453|NCT00327171|Secondary|Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC.|"PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier.~The number of participants with tumor/disease progression are reported. Participants who did not reach tumor progression during study, or had no valid post-baseline tumor burden assessment due to early termination, were censored in the PFS analysis."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||participants|||Number
1273454|NCT00327171|Secondary|Time to Tumor Marker (CA-125) Progression (TTMP)|"TTMP was the time interval from the date of randomization to the date of tumor marker progression as was defined by GCIG for the evaluable participants. TTMP was estimated using Kaplan-Meier curves.~For a participant who did not reach tumor marker progression (TMP) during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Participants with a valid assessment of CA-125 (requiring at least one pretreatment sample and 2 post-treatment samples).|||weeks|Participants|95% Confidence Interval|Median
1273455|NCT00327171|Secondary|Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC|"TTP was defined as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST. TTP was estimated from Kaplan-Meier curves.~For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||weeks|Participants|95% Confidence Interval|Median
1273456|NCT00327171|Secondary|Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition|TMRR was the proportion of evaluable participants achieving a cancer antigen -125 (CA-125) response based on GCIG definition. A response to CA-125 occurred if after two elevated levels before therapy there was at least a 50% decrease in a post-treatment serum sample, which was confirmed by an independent sample collected 21 days or later that was =< 110% of the post-treatment serum sample.|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Randomized participants who received at least part of one dose of aflibercept, had a baseline tumor assessment, had a valid CA-125 assessment (requiring at least two pretreatment sample and 2 post-treatment samples), did not receive mouse antibodies and had no medical or surgical interference with their peritoneum or pleura in the previous 28 days.|||percentage of participants||95% Confidence Interval|Mean
1273457|NCT00327171|Secondary|Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC)|"DR was defined as the time interval from the first documentation of CR or PR to the date of tumor progression (or disease progression) as determined by RECIST, or death from any cause, whichever was earlier.~Based on RECIST, progressive disease was at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new target or non-target lesions, or the unequivocal progression of existing non-target lesions."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||days||Standard Deviation|Mean
1273458|NCT00327171|Secondary|Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC|"CBR was defined as having a Stable disease (SD) for >= 6 months or a confirmed OR (PR or CR). Based on RECIST:~SD was neither a sufficient shrinkage of the target lesions to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), the persistence of non-target lesions or the maintenance of tumor marker level above the normal limits (for non-target lesions)~CR was the disappearance of all target or non-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Simon's cohort: The first 67 evaluable participants, based on Simon’s two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.|||participants|||Number
1273459|NCT00327171|Primary|Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort|"OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference.~Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Simon's cohort: The first 67 evaluable participants, based on Simon’s two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.|||participants|||Number
1273460|NCT00327015|Secondary|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.|||Percentage of participants|||Number
1273461|NCT00327015|Secondary|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.|||Percentage of participants|||Number
1273462|NCT00327015|Secondary|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
1273463|NCT00327015|Secondary|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of Participants|||Number
1273464|NCT00327015|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
1273465|NCT00327015|Primary|Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||percent||Standard Error|Mean
1273466|NCT00327015|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
1273467|NCT00327015|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
1273559|NCT00326716|Primary|Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||ng / mL||95% Confidence Interval|Geometric Mean
1273468|NCT00327015|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
1273469|NCT00327015|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
1273470|NCT00327015|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
1273471|NCT00327015|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), subjects must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||percent||Standard Error|Mean
1273472|NCT00326963|Secondary|Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events|The total number and percentage of participants who discontinued the study medication (ENF) due to clinical adverse events (including clinically significant laboratory abnormalities and AIDS Clinical Trials Group (ACTG) grade≥3 laboratory toxicities) were noted and presented.|Up to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.|||participants|||Number
1273473|NCT00326963|Secondary|Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Grades 0 through 4 are a measure of intensity, not seriousness. Thus, a grade 3 or grade 4 sign or symptom could be severe, but not necessarily serious. Only active, ongoing ISR were counted. The maximum severity grade for pain/discomfort since the last visit at any injection site was recorded whether or not the maximum severity of pain/discomfort was ongoing at the time of clinical evaluation.|Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up. Maximum number of participants available at the particular time point were analysed and reported.|||participants|||Number
1273474|NCT00326963|Secondary|Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.|Week 1 to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.|||Percentage of participants|||Number
1273475|NCT00326963|Secondary|Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.|Week 1 to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.|||participants|||Number
1273476|NCT00326963|Secondary|Percentage of Participants Adhering to ENF|Adherence to ENF treatment regimen was calculated using the participant’s response to the query on the “Participant Adherence Questionnaire case report form (CRF)” about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.|||Percentage of Participants|||Number
1273477|NCT00326963|Secondary|Number of Participants Adhering to Enfuvirtide (ENF)|Adherence to ENF treatment regimen was calculated using the participant’s response to the query on the “Participant Adherence Questionnaire case report form (CRF)” about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population.The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.|||participants|||Number
1273478|NCT00326963|Secondary|Percentage of Participants Meeting Virologic Failure Criteria|The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.|Weeks 12 and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||Percentage of participants|||Number
1273479|NCT00326963|Secondary|Number of Participants Meeting Virologic Failure Criteria|The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.|Weeks 12 and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||participants|||Number
1273480|NCT00326963|Secondary|Change From Baseline in CD4+ Lymphocyte Count|Summary statistics for change from baseline in CD4+ lymphocyte count were presented . Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at Week X) – (CD4+ count at baseline).|Baseline (Day 1), Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.|||cells/mm^3||Standard Deviation|Mean
1273481|NCT00326963|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.|Up to Week 28|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.|||participants|||Number
1273482|NCT00326963|Secondary|Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load|Summary statistics for change from baseline in plasma HIV-1 RNA count were presented. Change from baseline in plasma HIV-1 RNA count was derived as follows: Change from baseline = (plasma HIV-1 RNA count at Week X) – (plasma HIV-1 RNA count at baseline).|Baseline (Day 1), Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.|||copies/mL||Standard Deviation|Mean
1273483|NCT00326963|Secondary|Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||Percentage of participants||95% Confidence Interval|Number
1273484|NCT00326963|Secondary|Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||participants|||Number
1273485|NCT00326963|Secondary|Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The percentage of participants with HIV-1 RNA Viral Load results <50 copies/mL is reported.|Week 4 and 12|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||Percentage of Participants||95% Confidence Interval|Number
1273579|NCT00326612|Secondary|Respiratory Depression Requiring Intubation|Respiratory depression was defined as intubation at Emergency Department discharge.|24 hours|Analysis was per protocol|||participants|||Number
1273486|NCT00326963|Secondary|Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported.|Week 4 and 12|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||participants|||Number
1273487|NCT00326963|Primary|Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results <50 copies/mL is reported.|Week 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||Percentage of Participants||97.5% Confidence Interval|Number
1273488|NCT00326963|Primary|Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results <50 copies/mL is reported.|Week 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||participants|||Number
1273489|NCT00326950|Secondary|Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.||3 weeks|||||||
1273490|NCT00326950|Primary|Maximum Tolerated Dose (MTD)|MTD was the lowest dose at which a dose limiting toxicity occurred.|3 Weeks||||mg/m^2|||Number
1273491|NCT00326950|Primary|Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)|DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)>/=Grade 3 febrile neutropenia, 3)>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to >/=Grade 3 neutropenia or thrombocytopenia or investigator decision.|3 weeks||||participants|||Number
1273492|NCT00326924|Secondary|Number of Participants Using Mechanical Ventilation.|Number of Participants using Mechanical Ventilation|whether a mechanical ventilation was used at any time point during 90 days||||participants|||Number
1273493|NCT00326924|Secondary|Length of Stay|Length of Stay in neonatal intensive unit|until last participants left neonatal intensive care unit||||number of days||Inter-Quartile Range|Mean
1273494|NCT00326924|Secondary|Clinically Suspected Infection and Culturally Confirmed Infections|Infection was categorized as clinically suspected and positive cultures.|90 days||||number of participants|||Number
1273495|NCT00326924|Primary|1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality|The primary outcome was a composite outcome composed of mortality and major neonatal morbidities associated with acute organ dysfunction or failure. In addition to death, the 4 major morbidities comprising the composite outcome were bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage.|2 weeks, 4 weeks, 12 weeks, 90 days||||participants|||Number
1273496|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Interference question (change from baseline) to Cycle 2 Week 4 is reported. Complete interference is scored as 10 and no interference is scored as 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273497|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Pain Right Now question (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273498|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Average Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain was 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273499|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Least Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273500|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Worst Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273501|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Legal Concerns question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273502|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Financial Concerns Question question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273503|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Support, Friends and Family question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population|||Scores on a scale||Standard Deviation|Mean
1273504|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Fatigue question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population|||Scores on a scale||Standard Deviation|Mean
1273505|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Severity of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug|mITT population|||Scores on a scale||Standard Deviation|Mean
1273506|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Frequency of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273507|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Spiritual Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug|mITT population|||Scores on a scale||Standard Deviation|Mean
1273508|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Social Activity question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273509|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Emotional Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population|||Scores on a scale||Standard Deviation|Mean
1273510|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Physical Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273511|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Mental Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273512|NCT00326911|Secondary|Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall QoL question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
1273513|NCT00326911|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Reported AEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for regulatory Activities dictionary. The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).|An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|All patients who received any quantity of study therapy were included in the safety evaluation (safety population, as treated).|||Participants|||Number
1273514|NCT00326911|Secondary|Time to Progression (TTP)|Time to progression was defined as the time from randomization until the date of objectively confirmed tumor progression was first reported. The censoring rule was consistent with PFS except death. Patients who died from any cause were censored at the time of death or at last tumor assessment date if the death date was missing. For patients lost to follow-up, they were censored at the last tumor assessment date.|Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months)|The TTP was based on the mITT population. For patients lost to follow-up, they were censored at the next scheduled visit.|||months||95% Confidence Interval|Median
1273515|NCT00326911|Secondary|Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).|CA19-9 is a tumor marker for pancreatic cancer and the level usually increases as the disease is progressing. The CA19-9 response was the percentage of patients whose CA19-9 level was declining, stable or increasing < 10% compared with baseline, divided by the total patients with elevated baseline CA19-9 in that arm.|First day of treatment to the end of Cycle 2, Week 1|The CA19-9 response rate was calculated for at least the 15 patients in each arm of the study at the end of the first two cycles of therapy (8 weeks) in the mITT population who had elevated CA19-9 levels at baseline.|||Percentage of participants|||Number
1273516|NCT00326911|Secondary|The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)|The best overall response is the number of patients with a best overall response of CR or PR, as classifed by the investigator according to the RECIST guidelines. A CR is the disappearance of all target lesions and a PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.|The best overall response was based on the mITT population for those patients who either had a CR or PR.|||Participants|||Number
1273517|NCT00326911|Secondary|Overall Survival (OS)|This measure is defined as the time from randomization to the date of death due to any cause. Survival of living patients or those who lost to follow-up were censored on the last date the patients were known to be alive.|Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months).|The overall survival was based on the mITT population.|||Months||95% Confidence Interval|Median
1273518|NCT00326911|Primary|Progression-free Survival (PFS)|Progression-free survival is the time from randomization until the date of progressive disease (PD) or death from any cause whichever is first reported. Patients who die without a reported prior progression were considered to have progresssed on the day of their death. Patients who did not progress were censored at the day of their last tumor assessment.|Time from randomization to disease progression or death from any cause (Range: 0 -10 months)|The PFS was based on the modified Intent-to-Treat (mITT) population, which included any patient who enrolled, was randomized, and received any quantity of study drug.|||months||95% Confidence Interval|Median
1273519|NCT00326898|Other Pre-specified|Frequency of Clinically Significant Congestive Heart Failure (CHF) Grade 3 or Higher Using the Common Terminology Criteria for Adverse Events Version 4.0||Assessed every 6 weeks while on treatment and for 30 days after the end of treatment|||||||
1273520|NCT00326898|Other Pre-specified|The Association Between Scan Frequency and Development of Congestive Heart Failure||Assessed at 3, 6 and 12 months|||||||
1273521|NCT00326898|Other Pre-specified|Patient-reported Fatigue Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form|PROMIS Fatigue short form is a newly developed state-of-the-science PROMIS measure for fatigue|Assessed at baseline, 10 weeks and 22 weeks|||||||
1273522|NCT00326898|Other Pre-specified|Patient-reported Fatigue Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale||Assessed at baseline, 10 weeks and 22 weeks|||||||
1273523|NCT00326898|Other Pre-specified|The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
1273524|NCT00326898|Other Pre-specified|The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
1273525|NCT00326898|Other Pre-specified|The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
1273526|NCT00326898|Other Pre-specified|The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
1273527|NCT00326898|Other Pre-specified|The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
1273580|NCT00326612|Primary|Length of Seizure After Study Medication Administration|Length of seizure.|24 hours|Analysis was per protocol|||Minutes||Inter-Quartile Range|Median
1273529|NCT00326898|Secondary|5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology|Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|Patients with clear cell histology were included in this analysis.|||proportion of participants||97.5% Confidence Interval|Number
1273530|NCT00326898|Secondary|Proportion of Patients With Cardiac Events|Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was >15% absolute percentage points from baseline within 6 months.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry|Patients with at least 1 follow-up MUGA scan were included in this analysis.|||Proportion of participants||90% Confidence Interval|Number
1273531|NCT00326898|Secondary|5-year Overall Survival Rate|Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry|All randomized patients|||proportion of participants||97.5% Confidence Interval|Number
1273532|NCT00326898|Primary|Disease-free Survival (DFS)|Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients|||years||97.5% Confidence Interval|Median
1273533|NCT00326885|Primary|Increase of Paracentesis/Puncture-free Interval (Ratio)|The parameter to be tested is the ratio of the post-treatment puncture/paracentesis-free interval divided by the pre-treatment puncture/paracentesis-free interval. The pre-treatment interval is defined as the length of time between the patient`s most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.|180 days||||fold||Full Range|Median
1273534|NCT00326885|Secondary|Ascites Volume|Ascites volume measurement were to be performed at screening (= prior to baseline), at baseline (= before start of therapy with catumaxomab) and during the 6-month follow-up period when the patient had recurrence of symptomatic ascites requiring therapeutic paracentesis. At each paracentesis, drainage to dryness was to be achieved and the exact volume was to be measured and documented.|6 months||||mL||Full Range|Median
1273535|NCT00326885|Secondary|Ascites Signs and Symptoms|"Patient-reported ascites symptoms were to be assessed using the patient questionnaire, Functional Assessment of Chronic Illness Therapy – Ascites Index (FACIT-AI). At 6 months following catumaxomab administration, the patient was requested to assess the severity of the following parameters during the past week using a 5-point scale with scores from 0 = not at all to 4 = very much: anorexia, insomnia, decreased mobility, dyspnea, nausea, vomiting, abdominal pain, abdominal distention, fatigue, early satiety, urinary frequency, constipation, and emotional distress. For the parameters anorexia, insomnia, and decreased mobility, high scores mean good response, for the other parameters low scores mean good response."|6 months||||units on a scale||Full Range|Median
1273536|NCT00326885|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from the date of first dose to the date of death.|≥ 6 months||||months||95% Confidence Interval|Median
1273537|NCT00326885|Secondary|Puncture/Paracentesis-free Survival (PuFS)|Puncture/Paracentesis-free Survival (PuFS), Defined as the Number of Days Between the Date of Last Dose and the Date of Documented End of Study (EoS) Paracentesis or Death, Whichever Occurred First|≥6 months|Full analysis set (FAS) Per protocol (PP)|||weeks||Full Range|Median
1273538|NCT00326885|Primary|The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.|The parameter to be estimated is the proportion of patients who achieve at least a 4-fold increase in their puncture/paracentesis-free interval. The pretreatment interval is defined as the length of time between the patient’s most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.|6 months||||proportion of patients|||Number
1273539|NCT00326872|Secondary|Reduction in Self Reported Worst Pain Per Cycle.|Reduction in self reported worst pain per cycle as measured by the Worst Pain scale from the North Central Cancer Treatment Group Brief Pain Inventory (short form). The worst pain scale is from 0-10 (10 is worst pain possible). The per-cycle average reduction in worst pain will be analyzed using generalized linear models to account for repeated measures within patients.|At baseline, prior to each subsequent course (q 28+/- 3 days), and at end of treatment up to 51 months||||units on a scale of 0-10||Standard Error|Mean
1273540|NCT00326872|Secondary|Time to Treatment Failure as Assessed Using the Method of Kaplan-Meier|"Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment.~Time to treatment failure will be estimated using the method of Kaplan-Meier."|From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal up to 51 months.||||Months||95% Confidence Interval|Median
1273638|NCT00325819|Secondary|Infant Fussiness|Parents were asked to record level of fussiness (compared with the child’s usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual.|Within 32 hours of vaccination||||percentage of participants|||Number
1273541|NCT00326872|Secondary|Duration of Response as Assessed Using the Method of Kaplan-Meier|Duration of response is defined for all evaluable patients who have achieved a confirmed tumor objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be estimated using the method of Kaplan-Meier.|From time of confirmed tumor objective response as CR or PR to the date of progression max 51 months|There was only 1 response and due to patient confidentiality we are not reporting this endpoint.||||||
1273542|NCT00326872|Secondary|Time to Disease Progression as Measured Using Kaplan-Meier Method|"Progression (PD): At least a 20% increase in the sum of volumes of target lesions taking as reference the smallest volume recorded since the treatment started or the appearance of one or more new lesions.~If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death."|From registration to documentation of disease progression up to 26 cycles (28 days/cycle).||||Months||95% Confidence Interval|Median
1273543|NCT00326872|Secondary|Survival Time as Measured Using Kaplan-Meier Method|Survival time is defined as the time from registration to death due to any cause.|From registration to death (due to any cause) max 51 months||||Months||95% Confidence Interval|Median
1273544|NCT00326872|Primary|Proportion of Patients With Tumor Response (Complete Response [CR] or Partial Response [PR])|"Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the volume of target lesions taking as reference the baseline volume."|Baseline to end of treatment, maximum of 26 cycles (28 days/cycle).||||Proportion of patients||95% Confidence Interval|Number
1273545|NCT00326781|Secondary|Verified 7-day Point Prevalence Abstinence at End Of Treatment.|"End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey.~This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey."|End of Treatment||||participants|||Number
1273546|NCT00326781|Primary|Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)|A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).|End of Treatment (8-weeks after quit date)|Analysis was intention to treat (ITT)|||Participants|||Number
1273547|NCT00326716|Primary|Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)|Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||Hours||95% Confidence Interval|Geometric Mean
1273548|NCT00326716|Primary|Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)|Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||Hours||95% Confidence Interval|Geometric Mean
1273549|NCT00326716|Primary|Mean RTV Terminal Elimination Half Life (T 1/2)|T 1/2 = terminal elimination half life of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set|||Hours||95% Confidence Interval|Geometric Mean
1273550|NCT00326716|Secondary|Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose|The MACS was administered to evaluate participant adherence to each drug and the adherence to the regimen. The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum|All treated participants were included in this evaluation.|||Participants|||Number
1273551|NCT00326716|Secondary|Mean Atazanavir Plasma Protein Binding|Atazanavir Plasma Protein Binding Percentage measured at specified time points.|Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery||||Percentage Bound||Standard Deviation|Mean
1273552|NCT00326716|Secondary|Median Infant Total Bilirubin Level|Median infant total bilirubin level as measured at specified time points.|Birth (Day 1), Day 3, Day 5, and Day 7 of Life||||mg / dL||Inter-Quartile Range|Median
1273553|NCT00326716|Secondary|Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration|Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery.|At Time of Delivery||||ng / mL||Standard Deviation|Mean
1273554|NCT00326716|Primary|Mean ATV Terminal Elimination Half Life (T 1/2)|T 1/2 = terminal elimination half life of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||Hours||95% Confidence Interval|Geometric Mean
1273555|NCT00326716|Primary|Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose|Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.|Treated participants in the PK concentration data set.|||ng•h / mL||95% Confidence Interval|Geometric Mean
1273556|NCT00326716|Primary|Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose|Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.|Treated participants in the PK concentration data set.|||ng•h / mL||95% Confidence Interval|Geometric Mean
1273560|NCT00326716|Primary|Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the pharmacokinetic (PK) concentration data set.|||ng / mL||95% Confidence Interval|Geometric Mean
1273561|NCT00326716|Primary|Infant Race||At the time of delivery|All infants.|||Participants|||Number
1273562|NCT00326716|Primary|Infant Gender||At the time of delivery|All infants.|||Participants|||Number
1273563|NCT00326716|Primary|Infant Gestational Age at Delivery||At the time of delivery|All infants.|||Weeks||Standard Error|Mean
1273564|NCT00326716|Secondary|SAEs in Enrolled Infants|SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.|Birth Through Week 16 of Life|SAEs were recorded for all enrolled infants.|||Participants|||Number
1273565|NCT00326716|Secondary|SAEs in Enrolled Mothers|SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.|During Study Period and 30 Days Post-Study.|Data were analyzed for all treated and untreated mothers.|||Participants|||Number
1273566|NCT00326716|Secondary|Number of Participants With Grade 2 to Grade 4 AEs and SAEs|AEs and SAEs considered possibly, probably, or certainly related to study treatment, were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). Hyperbilirubinemia (Grade 1=1.1 to 1.5 upper limit of normal [ULN] [mild], Grade 2=1.6 to 2.5 ULN [moderate], Grade 3=2.6 to 5.0 ULN [severe], Grade 4= > 5.0 ULN [potentially life threatening]).|During Study Period and 30 Days Post-Study.|Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants. The number of AEs and SAEs is based on enrolled participants.|||Participants|||Number
1273567|NCT00326716|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE =any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|During study period and 30 days post-study.|The number of SAEs is based on enrolled participants. Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants.|||Participants|||Number
1273568|NCT00326716|Secondary|Infant HIV Status|The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems).|Birth Through 6 Months on Study|All infants.|||Participants|||Number
1273569|NCT00326716|Secondary|Mean CD4 Cell Count at Baseline||Baseline|All treated participants.|||cells / mm^3||Standard Error|Mean
1273570|NCT00326716|Secondary|Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count|The median CD4 cell count change from baseline was calculated for all treated mothers at the time of delivery ± 2 days. Maternal CD4 cell counts were assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Baseline, Day of Delivery ± 2 Days|The median CD4 Cell Count Change From Baseline was calculated based on all treated mothers. The maternal CD4 cell count at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.|||cells / mm^3||Inter-Quartile Range|Median
1273571|NCT00326716|Secondary|Mean HIV RNA Level at Baseline||Baseline|All treated participants.|||log10 cm / mL||Standard Error|Mean
1273572|NCT00326716|Secondary|Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level|The maternal HIV RNA level was determined at baseline and the day of delivery ± 2 days using VR-OC. The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Baseline, Day of Delivery ± 2 Days|The median maternal HIV RNA Level Change From Baseline was calculated for all treated mothers at the time of delivery. The maternal HIV RNA level at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.|||log10 c / mL||Inter-Quartile Range|Median
1273573|NCT00326716|Secondary|Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery|The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Day of Delivery ± 2 Days|The analysis for the proportion of HIV RNA < 400 and < 50 c/mL at delivery is based on the Virologic Response - Observed Cases (VR-OC). VR-OC classifies subjects who remain on study therapy as responders according to a single HIV RNA measurement < 400 c/mL (or < 50 c/mL) closest to delivery and within delivery date ± 2 days.|||Participants|||Number
1273574|NCT00326612|Secondary|Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.|Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.|24 hours|Analysis was per protocol|||participants|||Number
1273575|NCT00326612|Secondary|Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication||12 hours||||participants|||Number
1273576|NCT00326612|Secondary|Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.||24 hours||||participants|||Number
1273577|NCT00326612|Secondary|Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.||24 hours||||participants|||Number
1273578|NCT00326612|Secondary|Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours||24 hours||||participants|||Number
1273581|NCT00326599|Secondary|Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)|DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) >5 days or of any duration with fever >38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of >14 days for drug-related toxicities.|Cycle 1 (up to 3 weeks)|The first 6 participants treated on Arm I (lead-in phase).|||participants|||Number
1273582|NCT00326599|Secondary|Overall Survival (Phase II Patients Only)|Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.|Up to 5 years|All phase II participants who met eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
1273583|NCT00326599|Secondary|Overall Survival at 1 Year After Randomization (Phase II Patients Only)|Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year.|1 year|All phase II participants who met eligibility criteria and started the treatment.|||percentage of participants||95% Confidence Interval|Number
1273584|NCT00326599|Secondary|Time to Treatment Failure (Phase II Patients Only)|Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.|Up to 15 months|All phase II participants who met the eligibility criteria and have ended the study treatment.|||months||95% Confidence Interval|Median
1273585|NCT00326599|Secondary|Progression-free Survival (Phase II Patients Only)|Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.|Up to 5 years|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.|||months||95% Confidence Interval|Median
1273586|NCT00326599|Secondary|Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)|"Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|6 months|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.|||percentage of participants||95% Confidence Interval|Number
1273587|NCT00326599|Primary|Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)|"A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions"|Up to 5 years|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.|||percentage of participants||95% Confidence Interval|Number
1273588|NCT00326495|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|96 months, 26 days|Although 51 patients were accrued, only 50 were on study long enough for assessment.|||Participants|||Count of Participants
1273589|NCT00326495|Primary|Overall Rate of Response|Rate of response is defined as the percentage of participants with a complete response (CR) + partial response (PR) + stable disease (SD) for 4 months. Response is defined by the Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response is a disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|4 months|Although 51 patients were accrued, only 50 were on study long enough for assessment.|||percentage of participants|||Number
1273590|NCT00326417|Secondary|Overall Survival (OS)|OS is defined as alive at 1 year, the event is death from any cause. Patients alive at the time of last observation, for statistical purposes, will have a survival time which is censored.|Day 365||||percentage of participants||95% Confidence Interval|Number
1273591|NCT00326417|Secondary|Chronic GVHD|Chronic GVHD is scored according to the BMT CTN MOP. The first day of chronic GVHD onset will be used to calculate cumulative incidence curves.|Day 365||||percentage of participants||95% Confidence Interval|Number
1273592|NCT00326417|Secondary|Acute Graft vs Host Disease (GVHD)|All GVHD grades 2-4 will be graded according to the BMT CTN Manual of Procedures (MOP)|Day 100||||percentage of participants||95% Confidence Interval|Number
1273593|NCT00326417|Secondary|Cumulative Incidence of Graft Failure|Primary and secondary graft failure are included, secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in the ANC to less than 0.5 x 10^9/L for three consecutive measurements on different days, unresponsive to growth factor.|Day 365||||percentage of participants|||Number
1273594|NCT00326417|Primary|Disease-free Survival (DFS)|DFS includes graft failure, regimen-related toxicity (RRT), and early death. Graft Failure is defined by lack of neutrophil engraftment (ANC less than 0.5 x 10^9/L for 3 consecutive days on different days). Major RRT is defined as severity of grade 4 in any organ system or grade 3 for pulmonary, cardiac, renal, oral mucosal or hepatic. Early death is defined as death prior to Day 100 post-transplant.|Day 100||||participants|||Number
1273738|NCT00325130|Primary|Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
1273595|NCT00326196|Primary|The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.|Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.|Date of Death and non-fatal MI|The number of participants for analysis was determined by intent to treat principal.|||participants|||Number
1273596|NCT00326183|Primary|Participants With Elevated Temperature (>=102.2F/39.0C)||Days 1 to 5 After Any Vaccination|Includes all subjects who provided body temperature follow-up data after any dose of vaccine.|||participants|||Number
1273597|NCT00326183|Primary|Participants With Varicella/Zoster-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
1273598|NCT00326183|Primary|Participants With Varicella/Zoster-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
1273599|NCT00326183|Primary|Participants With Rubella-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
1273600|NCT00326183|Primary|Participants With Rubella-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
1273601|NCT00326183|Primary|Participants With Mumps-Like Symptoms After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.|||participants|||Number
1273602|NCT00326183|Primary|Participants With Mumps-Like Symptoms After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.|||participants|||Number
1273603|NCT00326183|Primary|Participants With Measles-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
1273604|NCT00326183|Primary|Participants With Measles-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes.|||participants|||Number
1273605|NCT00326183|Primary|Participants With 1 or More Injection-Site Adverse Experiences||Days 1 to 14 after any vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.|||participants|||Number
1273606|NCT00326183|Secondary|Participants With 1 or More Systemic Adverse Experiences||Days 1 to 14 After Any Vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.|||participants|||Number
1273607|NCT00326183|Primary|Participants With 1 or More Serious Vaccine-Related Adverse Experiences||Days 1 to 14 after any vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.|||participants|||Number
1273608|NCT00326170|Primary|Number of Participants With Response|Clinical activity of combination defined as: Complete Response (CR), bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/L or more and platelet count of 100x10^9 or more; Complete response without platelets (CRp), a complete response except for a platelet count less than 100x10^9 and transfusion independent; and Bone Marrow (BM) Response, bone marrow blast of 5% or less but without meeting the peripheral blood count criteria for (CR) or (CRp).|Up to 12 cycles of treatment (28 day cycles)||||Participants|||Number
1273609|NCT00326118|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|"A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.~For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually."|Throughout the entire study period (up to year 5)|Analysis was performed on vaccinated subjects from the Total Vaccinated Cohort for the Vaccination Phase of the study (up to Month 1) and on the Total Enrolled Cohort up to Year 5, which included all vaccinated subjects in the vaccination phase who came back for the Year 1, Year 2, Year 3 ,Year 4 and/or Year 5 persistence phases of the study.|||Subjects|||Number
1273610|NCT00326118|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.|Within 31 days (Day 0 - Day 30) after vaccination|Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.|||Subjects|||Number
1273611|NCT00326118|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite."|Within 4 days (Day 0 -Day 3) after vaccination|Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.|||Subjects|||Number
1273639|NCT00325819|Secondary|Medical Utilization|Telephone calls to the consulting nurse or the child’s physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination.|Within 32 hours of vaccination.||||percentage of participants|||Number
1273612|NCT00326118|Secondary|Anti-polysaccharide C (Anti-PSC) Antibody Concentrations|Concentrations given as Geometric Mean Concentrations (GMCs).|Prior to, 1 month, 1 year, 2 years and 3 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1273613|NCT00326118|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values|Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.|Prior to, 1 month, 1 year, 2 years and 3 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
1273614|NCT00326118|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs).|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.|||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1273615|NCT00326118|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs).|Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1273616|NCT00326118|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values|Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
1273617|NCT00326118|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values|Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
1273618|NCT00326118|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers|Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
1273619|NCT00326118|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers|Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
1273620|NCT00326118|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values|rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
1273621|NCT00326118|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values|"rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers.~Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition."|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
1273640|NCT00325819|Secondary|Study Assignment Unblinded|The need for unblinding at any time during the study|At any time during participation in the study||||percentage of participants|||Number
1273622|NCT00326118|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer|rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.|1 month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.|||Subjects|||Number
1273623|NCT00326118|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)|Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.|1 month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.|||Subjects|||Number
1273624|NCT00326001|Secondary|Number of Patients With Charred Catheter Tips|Char or coagulum formation on the catheter tip|ablation procedure|per protocol|||Patients|||Number
1273625|NCT00326001|Secondary|Number of Patients With Long-term Treatment Success|No recurrence of atrial flutter after ablation|6 months after ablation|per protocol|||Patients|||Number
1273626|NCT00326001|Secondary|Ablation Success With the First Catheter|"Delivery of radiofrequency current was repeated until a cavotricuspid isthmus (CTI) conduction block was detected. The final bidirectional CTI block test (well documented in the literature) was performed 20 minutes after the last radiofrequency current delivery to assess ablation success (Y/N).~Positive final bidirectional cavotricuspid isthmus condution block test means ablation successful.~Negative final bidirectional cavotricuspid isthmus condution block test means ablation unsuccessful; ablation should be continued until success or terminated and classified as unsuccess."|ablation procedure|per protocol|||Patients|||Number
1273627|NCT00326001|Primary|Duration of Energy Application|Cumulative amount of time current is flowing through the catheter tip. The current (in the radiofrequency range) is applied to ablate the cavotricuspid isthmus in the right atrium.|ablation procedure|Per protocol|||minute||Standard Deviation|Mean
1273628|NCT00325897|Secondary|Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum|Cultures from some participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.|During Course of Study (either month 3, 6, 9, or 12)|Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.|||participants|||Number
1273629|NCT00325897|Secondary|Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum|Cultures from 68% of the participants in the azithromycin group and 70% in the placebo group who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.|Baseline|Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.|||Participants|||Number
1273630|NCT00325897|Secondary|Change in Age-adjusted Hearing Threshold|Assessed by audiometry for four sound frequencies (1000, 2000, 3000, 4000 Hz). The maximum was computed for each threshold in each ear for all frequencies, then the differences between visits were assessed.|Baseline and 12 months|Participants with both baseline and one-year audiometry data available were analyzed.|||Decibels (db)||Standard Deviation|Mean
1273631|NCT00325897|Secondary|Number of Hospital Admissions as a Result of Acute Exacerbations||Measured monthly for 12 months||||Hospitalizations|||Number
1273632|NCT00325897|Secondary|Number of Emergency Department Visits as a Result of Acute Exacerbations||Measured monthly for 12 months||||Visits|||Number
1273633|NCT00325897|Secondary|Exacerbations/Patient Year|"Acute exacerbations are defined as a complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "|Measured monthly until 13 months|Participants with any follow-up data were analyzed.|||exacerbations/patient year|||Number
1273634|NCT00325897|Primary|Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Time until first occurrence of acute Chronic Obstructive Pulmonary Disease (COPD) exacerbation. Acute exacerbations are defined as a complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "|Measured monthly through 13 months|Participants that had any follow-up data were included in analysis.|||Days||95% Confidence Interval|Median
1273635|NCT00325819|Secondary|Parent Time Lost From Work|Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days.|Through the day after vaccination|Refers to the number of participants for whom parents reported that they were scheduled to work on the day of the vaccination visit or the day following the child's vaccination visit.|||percentage of participants|||Number
1273636|NCT00325819|Secondary|Infant Time Lost From Sleep|Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.|On the night following vaccinations||||percentage of participants|||Number
1273637|NCT00325819|Secondary|Parent Time Lost From Sleep|Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.|On the night following vaccinations||||percentage of participants|||Number
1273645|NCT00325754|Secondary|Mid-day Activity Monitoring at 6 Months|Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM.|6 months||||Vector magnitude units (VMU)/min||Standard Deviation|Mean
1273646|NCT00325754|Secondary|Average Mid-day Activity Monitoring at 3 Months|Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.|3 Months||||Vector magnitude units (VMU)/min||Standard Deviation|Mean
1273647|NCT00325754|Primary|Stationary Oxygen Use Daily||Baseline||||Hours||Standard Deviation|Mean
1273648|NCT00325754|Primary|Ambulatory/Portable Oxygen Use Daily||6 months||||Hours||Standard Deviation|Mean
1273649|NCT00325754|Primary|Stationary Oxygen Use Daily||6 Months||||Hours||Standard Deviation|Mean
1273650|NCT00325598|Secondary|Distant Control Rate|-Distant control rate for this study is the number of participants who remained free of cancer at distant sites which is defined as all parts of the body that are not the ipsilateral breast or ipsilateral regional lymph nodes.|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
1273651|NCT00325598|Secondary|Regional Control Rate|-Regional control rate for this study is the number of participants who remained free from disease in the regional lymph nodes. The regional lymph nodes are the axilla, infraclavicular, supraclavicular, and internal mammary lymph node beds|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
1273652|NCT00325598|Secondary|Local Control Rate|-Local control rate for this study is the number of participants who remained free of disease in their breast.|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
1273653|NCT00325598|Secondary|Cosmetic Outcome|"Excellent: little or no observable change~Good: minimal but identifiable changes~Fair: significant results of radiotherapy noted~Poor: severe normal tissue sequelae"|Up to 5 years|4 patients in Cohort 1 were not evaluable for this outcome measure because 2 patients did not have the cosmetic outcome performed, 1 patient withdrew consent, and 1 patient was lost to follow-up.|||Participants|||Count of Participants
1273654|NCT00325598|Secondary|Incidence of Fat Necrosis|-Fat necrosis typically causes a painless mass located superficially in the breast, accompanied by retraction or dimpling of the overlying skin. The skin may be thickened clinically and radiologically. Fat necrosis is firm and relatively circumscribed on palpation. Mammography usually reveals a spiculated, often poorly defined mass that may contain punctate or large, irregular calcifications. Attachment to the skin, dimpling, and thickening of the skin are often evident. Less frequently, the lesion consists of a circumscribed, oil-filled, partly calcified cyst. Early in its development, fat necrosis has the appearance of hemorrhage in indurated fat. After several weeks, the affected area becomes demarcated, forming a distinct yellow-gray and focally reddish tumor. Cystic degeneration may develop in the center of such a lesion, resulting in a cavity that contains oily fluid or necrotic fat.|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
1273655|NCT00325598|Secondary|Incidence of Breast Fibrosis||Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
1273656|NCT00325598|Secondary|Incidence and Severity of Cutaneous Toxicity|"Uses RTOG/EORTC Late Radiation Morbidity Scoring Scheme~Grade 0 = none~Grade 1 = slight atrophy; pigmentation change; some hair loss~Grade 2 = patch atrophy; moderate telangiectasia; total hair loss~Grade 3 = marked atrophy; gross telangiectasia~Grade 4 = ulceration~Worst cutaneous toxicity grade is noted"|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
1273657|NCT00325598|Primary|Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity|-The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity|Within 1 year of protocol registration||||percentage of participants|||Number
1273658|NCT00325598|Primary|Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan|-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.|Within 1 year of protocol registration||||percentage of participants|||Number
1273659|NCT00325468|Secondary|Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||Inter-Quartile Range|Median
1273660|NCT00325468|Primary|Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||95% Confidence Interval|Least Squares Mean
1273661|NCT00325468|Primary|Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||95% Confidence Interval|Least Squares Mean
1273662|NCT00325468|Secondary|Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||Inter-Quartile Range|Median
1273663|NCT00325468|Primary|Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||95% Confidence Interval|Least Squares Mean
1273664|NCT00325442|Secondary|Change in Symptoms of PAH From Baseline to Week 16|Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 16. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom. The outcome data describes the change in severity values from Baseline to Week 16 for each defined symptom of PAH.|Baseline and 16 weeks||||units on a scale||Standard Error|Mean
1273665|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: ERA and PDE5-I||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with an ERA and PDE5-I for 90 days or greater at the time of randomization.|||meters||Inter-Quartile Range|Median
1273666|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: PDE5-I||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with a PDE5-I for 90 days or greater at the time of randomization.|||meters||Inter-Quartile Range|Median
1273667|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: ERA||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with an ERA for 90 days or greater at the time of randomization.|||meters||Inter-Quartile Range|Median
1273668|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Study Drug Dose Strength Available at Randomization: Study Drug Dose 0.25 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 0.25 mg for initiation of study drug dosing and dose titration.|||meters||Inter-Quartile Range|Median
1273669|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Study Drug Dose Strength Available at Randomizaiton: Dose Strength 0.5 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 0.5 mg for initiation of study drug dosing and dose titration.|||meters||Inter-Quartile Range|Median
1273670|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Dose Strength Available at Randomization: Smallest Dose Available 1 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 1 mg for initiation of study drug dosing and dose titration.|||meters||Inter-Quartile Range|Median
1273671|NCT00325442|Post-Hoc|Change in Six Minute Walk Distance (6MWD) From Baseline in Subjects Who Received Oral Treprostinil by Last Study Drug Dose and Reason for Discontinuation|In general, the dose of study drug was increased in 0.5 mg increments every 3 days, in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.|Baseline and 16 weeks|Of 174 subjects randomized to receive oral treprostinil, 153 subjects who completed the study and 6 additional subjects who did not complete the study but discontinued the study due to adverse events were included in this analysis.|||meters||Inter-Quartile Range|Median
1273672|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 4 (398 - 450 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 4 (398 - 450 meters).|||meters||Inter-Quartile Range|Median
1273673|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 3 (363 - 397 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 3 (363 - 397 meters).|||meters||Inter-Quartile Range|Median
1273674|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 2 (303 - 362 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 2 (303 - 362 meters).|||meters||Inter-Quartile Range|Median
1273675|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartiles: Quartile 1 (126-302 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 1 (126 - 302 meters).|||meters||Inter-Quartile Range|Median
1273676|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 4 weeks||||meters||Inter-Quartile Range|Median
1273677|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 8 weeks||||meters||Inter-Quartile Range|Median
1273678|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 12 weeks||||meters||Full Range|Median
1273679|NCT00325442|Secondary|World Health Organization Functional Classification for PAH|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Week 16||||participants|||Number
1273720|NCT00325195|Primary|Plasma Uric Acid (PUA) Responder|PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations < 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.|Months 3 and 6|Modified ITT (all patients receiving at least one dose of study drug). Participants dropping out before Week 25 were imputed as Non-Responders|||Participants|||Number
1273680|NCT00325442|Secondary|Dyspnea-Fatigue Index|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and 16 Weeks|Five subjects in the placebo arm and three subjects in the active arm did not have a Baseline dypsnea-fatigue index score.|||units on a scale||Standard Deviation|Mean
1273681|NCT00325442|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening required one of the following:~Death (all causes excluding accident)~Transplantation or atrial septostomy~Clinical deterioration as defined by:~Hospitalization as a result of PAH, or~≥ 20% decrease in 6-minute walk distance from Baseline (or too ill to walk) and a decrease in WHO functional class And~Initiation of new PAH specific therapy (i.e., ERA, PDE5I, prostacyclin)."|Baseline and 16 Weeks||||participants|||Number
1273682|NCT00325442|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and 16 Weeks|One subject in the placebo arm did not have a Baseline Borg score value.|||units on a scale||Standard Deviation|Mean
1273683|NCT00325442|Primary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 16 Weeks||||meters||Inter-Quartile Range|Median
1273684|NCT00325416|Other Pre-specified|Breast Cancer Resistance Protein (BCRP) Expression|BCRP function will be assayed in multiple myeloma patient bone marrow aspirates obtained before and during high dose chemotherapy. BCRP function is expressed as the change in relative fluorescence in topotecan versus control cells. The distribution of paired differences in BCRP, a continuous variable, will be summarized using descriptive statistics and will be correlated with response and toxicity.|Laboratory study (N/A)|||||||
1273685|NCT00325416|Other Pre-specified|Genomic DNA Sequence Variations and Correlate With Toxicity to Melphalan and Topotecan|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (N/A)|||||||
1273686|NCT00325416|Other Pre-specified|DNA Topoisomerase I Amount, Activity, or Subcellular Distribution|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (N/A)|||||||
1273687|NCT00325416|Other Pre-specified|Amount, Activity and Subcellular Distribution of Topoisomerase I With Clinical Response and Toxicity|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (no specific time points)|||||||
1273688|NCT00325416|Other Pre-specified|Pharmacokinetic Profiles of High Dose Topotecan and Melphalan|Evaluate the pharmacokinetic profiles of high dose topotecan and melphalan and to investigate the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen in each age group. Pharmacokinetics of Topotecan: For all dose levels, topotecan levels on Day -4 will be obtained at -15 min, 20 min into 30 min infusion, and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, and 23 h after the 30 min infusion. Pharmacokinetics of Melphalan: For all dose levels, melphalan levels during the first day of cytoxan priming chemotherapy and on Day -4 will be obtained before, at the end of the infusion, and 5 minutes (min), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min and 180 min after the infusion. The infusion time for the test dose of melphalan is over 5 min and for the high-dose is over 30 min.|Predetermined time points in protocol|||||||
1273689|NCT00325416|Secondary|Phase II Overall Survival (OS)|Time from start of treatment until death from any cause.|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) evaluable participants at time of analysis|||months||95% Confidence Interval|Median
1273690|NCT00325416|Secondary|Phase II Event Free Survival (EFS)|Time to treatment failure, which is defined as the time from day 0 to the time of progressive disease. Progressive disease is defined by unequivocal objective evidence and constitutes any of the following: 1). an increase in the total amount of monoclonal protein (M-component from Serum Protein Electrophoresis (SPEP) and/or Urine Protein Electrophoresis (UPEP) with immunofixation) by more than 100% from the lowest level of serum myeloma protein seen after high-dose chemotherapy by serum protein electrophoresis; 2). an increase in the total amount of monoclonal protein above the remission level of the myeloma peak (i.e., an increase of >25% above the lowest level in a 24 hour urine or serum protein; 3). the reappearance of the M-protein if the patient had entered a CR: 4). definite increase in the size (> 1 cm) or number of lytic bone lesions. Compression fractures do not constitute a relapse.|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) evaluable participants at time of analysis|||months||95% Confidence Interval|Median
1273691|NCT00325416|Primary|Phase II Participants - Overall Response Rate|Re-evaluation of participants who had responsive disease prior to transplant. All changes in monoclonal protein and immunoglobulins will be referenced to those levels obtained immediately prior to cyclophosphamide priming chemotherapy. Complete Response (CR): A CR will be defined as the disappearance of the monoclonal protein by immunofixation studies of serum and urine (100x concentrate) and less than or equal to 5% plasma cells in a bone marrow aspirate. Partial Response (PR): 50% - 74% decrease in the measurable monoclonal protein (M-component from an SPEP and/or UPEP with immunofixation).|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) participants with responsive disease prior to transplant.|||percentage of participants|||Number
1273692|NCT00325416|Primary|Phase I - Maximum Tolerated Dose (MTD) Level|"MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety.~Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2"|Phase I - 5 years, 2 months|Phase I Dose Escalation participants.|||mg/m^2|||Number
1273693|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 4|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.|||meters||Inter-Quartile Range|Median
1273694|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 8|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.|||meters||Inter-Quartile Range|Median
1273695|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration. This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at the time of randomization.~The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 11|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.|||meters||Inter-Quartile Range|Median
1273696|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data collected from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Wk 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference i"|Baseline and Week 12|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.|||meters||Inter-Quartile Range|Median
1273697|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) by PAH Etiology: Idiopathic or Heritable PAH|"Exploratory efficacy analyses were to determine the effect of PAH etiology (idiopathic/heritable, associated with collagen vascular disease, and other etiologies) on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12||||meters||Inter-Quartile Range|Median
1273698|NCT00325403|Post-Hoc|Six Minute Walk Distance by Baseline WHO Functional Classification: I or II|"Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12||||meters||Inter-Quartile Range|Median
1273699|NCT00325403|Post-Hoc|Six Minute Walk Distance by Baseline WHO Functional Classification III or IV|"Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12||||meters||Inter-Quartile Range|Median
1273700|NCT00325403|Secondary|Symptoms of PAH|Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 12. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom.|Baseline and Week 12||||units on a scale||Standard Deviation|Mean
1273701|NCT00325403|Secondary|Dyspnea-Fatigue Index|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and Week 12|Two subjects (one in the placebo arm and one in the oral treprostinil arm) from the primary analysis population (n=228) did not have a Baseline dyspnea-fatigue index score and were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1273702|NCT00325403|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and Week 12||||units on a scale||Inter-Quartile Range|Median
1273703|NCT00325403|Secondary|World Health Organization Functional Classification for PAH|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Baseline and Week 12|Subjects with a WHO functional classification assessment at Week 12.|||participants|||Number
1273704|NCT00325403|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:~Death (all causes excluding accident)~Transplantation or atrial septostomy~Clinical deterioration as defined by:~Hospitalization as a result of PAH, or~greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And~Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)"|Baseline and Week 12||||participants|||Number
1273705|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 4|Analyses were conducted using the modified intention to treat (mITT), which includes subjects who had access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).|||meters||Inter-Quartile Range|Median
1273706|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 8|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).|||meters||Inter-Quartile Range|Median
1273707|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration.~The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 11|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).|||meters||Inter-Quartile Range|Median
1273719|NCT00325195|Secondary|Reduction in Tophus Burden|percentage of tophaceous subjects who demonstrated a complete resolution (100 % decrease in measured area or complete disappearance)of at least one tophus in the absence of other tophus progression or new tophi, as assessed by a blinded Central Reader using standardized digital photographs and image analysis software.|Baseline and Final Visit (6 months or LOCF)|Number of participants analyzed was based upon the number of patients who had one or more tophus at Baseline, as determined by the PI, AND who had at least one follow-up assessment, with the final visit for each subject included (last observation carried forward).|||Percent subjects with resolved tophus|||Number
1273736|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||mMU/mL||95% Confidence Interval|Geometric Mean
1273708|NCT00325403|Primary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).|||meters||Inter-Quartile Range|Median
1273709|NCT00325234|Secondary|Number of Participants With Adverse Events (AE)|A listing of adverse events is presented in the Reported Adverse Event Module.|every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)|All randomized participants who received at least one dose of study drug.|||participants|||Number
1273710|NCT00325234|Secondary|Time to Response|Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions.|Baseline to response (up to 7.8 months)|All randomized participants with CR or PR.|||Months||95% Confidence Interval|Median
1273711|NCT00325234|Secondary|Time To Treatment Failure (TTTF)|TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.|Baseline to end of treatment (up to 21.9 months)|All randomized participants|||Months||95% Confidence Interval|Median
1273712|NCT00325234|Secondary|Time to Progressive Disease (PD)|Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.|Baseline to measured PD (up to 25.1 months)|All randomized participants.|||Months||95% Confidence Interval|Median
1273713|NCT00325234|Secondary|Duration of Response (DOR)|DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.|Time of response to progressive disease (up to 19 months)|All randomized participants with CR or PR.|||Months||95% Confidence Interval|Median
1273714|NCT00325234|Primary|Tumor Response Rate|Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.|Baseline up to 30 days of follow-up after 21 cycles of treatment|All randomized patients who qualified for tumor response analysis by the following criteria: Females with histologic or cytologic diagnosis of advanced breast cancer previously treated with anthracyclines and taxanes. No concurrent antitumor therapy. Presence of measurable disease as defined by RECIST. Treatment with at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1273715|NCT00325195|Secondary|Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life|Health Assessment Questionnaire(HAQ: VAS pain scale where 0 (no pain)-100 (severe pain); HAQ disability index (HAQ-DI) on a scale from 0(no disability) to 3 (completely disabled), and a unit change of > or =0.22 is considerd a mimimal clinically important difference(MCID). SF-36 Physical Component Summary Score (SF36-PCS), a composite score where 0 is the worst score and 100 the best possible, and where a change of > or =2.5 units in the PCS is considered a MCID.|Baseline to Final Visit (Month 6 or LOCF)|Number of participants analyzed was based upon the number who had baseline and at least one follow-up assessment, with the final visit for each subject included (LOCF).|||Units on a scale||Standard Deviation|Mean
1273716|NCT00325195|Secondary|Change in Number of Tender Joints|Change from Baseline to Month 6 (or last observation carried forward) in number of tender joints per participant|Baseline and Final Visit (Month 6 or LOCF)|All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.|||Tender joints||Standard Deviation|Mean
1273717|NCT00325195|Secondary|Change in Number of Swollen Joints|Change from Baseline to Month 6 (or last observation carried forward)in number of swollen joints per subject. Values were inputed using last observation carried forward analysis for subjects who did not complete the studies.|Baseline and Final Visit (Month 6 or LOCF)|All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.|||Swollen joints||Standard Deviation|Mean
1273718|NCT00325195|Secondary|Percentage of Subjects With Gout Flare Per 3-month Period|Percent of participants reporting a gout flare during Months 1-3 and Months 4-6. Denominator during the respective period was based upon number of participants during that period.|Months 1-3 and Months 4-6|Number analyzed in each period was based upon number of participants remaining in study during the assessed treatment period: 85/84/43 in Months 1-3 and 69/69/43 in Months 4-6|||Percent subjects reporting flares|||Number
1273721|NCT00325156|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1273722|NCT00325156|Secondary|Number of Subjects Reporting Large Injection Site Swelling|A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.|At Month 18, post-booster dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.|||Subjects|||Number
1273723|NCT00325156|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1273724|NCT00325156|Primary|Number of Subjects Reporting Any Solicited Local and General Symptoms|Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.|||Subjects|||Number
1273725|NCT00325143|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 21)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1273726|NCT00325143|Secondary|Number of Subjects Reporting Any Large Swelling Reactions|A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.|At Month 15, post-booster dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1273727|NCT00325143|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1273728|NCT00325143|Primary|Number of Subjects Reporting Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet.|||Participants|||Count of Participants
1273729|NCT00325143|Primary|Number of Subjects Reporting Any Solicited Local Symptoms|Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet.|||Participants|||Count of Participants
1273730|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."|||ELISA units/mL||95% Confidence Interval|Geometric Mean
1273731|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."|||ELISA units/mL||95% Confidence Interval|Geometric Mean
1273732|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."|||ELISA units/mL||95% Confidence Interval|Geometric Mean
1273733|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."|||ELISA units/mL||95% Confidence Interval|Geometric Mean
1273734|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have~post-vaccination data."|||mMU/mL||95% Confidence Interval|Geometric Mean
1273735|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have~post-vaccination data."|||mMU/mL||95% Confidence Interval|Geometric Mean
1273739|NCT00325130|Primary|Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
1273740|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
1273741|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
1273742|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
1273743|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
1273744|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
1273745|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
1273746|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
1273747|NCT00325130|Secondary|Acceptable Safety Profile||15 days post injection|||||||
1273748|NCT00325130|Primary|Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
1273749|NCT00325078|Other Pre-specified|Gut Immune Cell Types and Their Cytokine Profile|Gut Immune cell types and their cytokine profile|1 year|||||||
1273750|NCT00325078|Primary|Efficacy of Treatment With Study Drug|Measured participant Crohn’s disease Activity Index (CDAI) values. The CDAI is a tool comprised of clinical and laboratory factors such as stool frequency, consistency, abdominal pain, general well being, weight and blood profile as an objective measure of disease activity. A higher score corresponds to greater severity of inflammatory bowel disease; severe disease conventionally defined as >450, a remission as <150, and a response to treatment as a fall of CDAI of >70 points. Infections and IBD are not expected in healthy control subjects. The greater the score, the more severe the disease, and a score of less than 5 represents clinical remission.|Baseline, 1 year|All participants in the Treatment and Observation Arms with collected CDAI data. The CDAI, a tool validated for Crohn’s disease is not applicable to healthy donors or CGD patients without IBD, and therefore not measured in the Control participants.|||Crohn's disease activity Index|||Number
1273751|NCT00325078|Primary|Safety of Study Drug|Number of Infections from Baseline to 1 year|Baseline to 1 year|The volunteer group includes patients with chronic granulomatous disease as well as healthy normal volunteers as controls. Infection rates only pertain to and are counted in subjects with underlying immunodeficiency (chronic granulomatous disease).|||infections|||Number
1273752|NCT00325039|Secondary|Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months|Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)|12 months|This is the number of participants who had complete UDI information at the 12 month visit.|||units on a scale||Standard Deviation|Mean
1273753|NCT00325039|Secondary|Change in Quality of Life From Baseline to 12 Months|Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).|Baseline - 12 months|These are the number of patients with available quality of life data at the 12 month visit.|||units on a scale||Standard Deviation|Mean
1273754|NCT00325039|Primary|Subjective Treatment Success at 12 Months|Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.|12 months|Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 in the Retropubic arm and n=292 in the transobturator arm).|||percentage of participants|||Number
1273755|NCT00325039|Secondary|Patient Satisfaction at 12 Months|"Patient satisfaction was assessed at the 12 month visit with the questions, how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage? Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as satisfied and neutral, most dissatisfied and completely dissatisfied as not satisfied."|Follow-Up|This is the number of women who answered the satisfaction questions at the 12 month visit (n=280 attended the 12 month visit in the retropubic arm and n=285 in the transobturator arm)|||percentage of participants analyzed|||Number
1273768|NCT00324961|Secondary|Change From Baseline in Median Serum HBV DNA Over Time|The HBV DNA level was tested in blood serum by real-time PCR with the LLD as 300 copies/mL at baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104 in a central laboratory.|Baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once.|||log10 copies/mL||Full Range|Median
1273756|NCT00325039|Primary|Objective Treatment Success at 12 Months|"Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures~A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is <15g/24 hrs."|12 months|Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 and n=292 in RMUS, TMUS, respectively).|||percentage of participants|||Number
1273757|NCT00324987|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 7 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
1273758|NCT00324987|Secondary|Central-review Based Progression-free Survival (CRb-PFS)|From date of registration (defined as date of randomization) to date of first documentation of one of the following events: death; first documentation of progression based on central review of the appropriate computed tomography (CT) or magnetic resonance imaging (MRI) scans; development of new lesions or disease not identified on CT or MRI; or symptomatic deterioration. Patients not experiencing any of these events will be censored at last date of contact.|up to 7 years|Data not collected as study accrued only 2% of the 572 patients planned. No scientific conclusions were forthcoming because of the small number of patients entered in the study.||||||
1273759|NCT00324987|Secondary|Overall Survival|From date of registration (defined as date of randomization) to date of death due to any cause. Patients last known to be alive are censored at last date of contact. Note: median was not reached in the Imatinib arm due to limited follow-up data.|up to 7 years|No scientific conclusions were forthcoming because of the small number of patients entered in the study.|||months||95% Confidence Interval|Median
1273760|NCT00324987|Primary|Progression Free Survival|From date of registration (defined as date of randomization) to date of first observation of progressive disease, death due to any cause or symptomatic deterioration. Patients last known to be alive and progression free are censored at last date of contact. Progression is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), provided at least one target lesion does NOT demonstrate uniform hypoattenuation over > 90% of maximal cross sectional area; unequivocal progression of non-measurable disease; appearance of new lesion/site that is not uniformly hypoattenuating; a hyperattenuating region within a previously cystic/uniformly hypoattenuating lesion will be considered progressive disease if hyperattenuating region is either >= 1 cm in longest diameter or round/oval and forms acute margins with border of target lesion; death due to disease.|Up to 7 years|No scientific conclusions were forthcoming because of the small number of patients entered in the study.|||months||95% Confidence Interval|Median
1273761|NCT00324987|Secondary|Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 7 years|Only eligible and evaluable patients included. No scientific conclusions were forthcoming because of the small number of patients entered in the study.|||Participants|||Count of Participants
1273762|NCT00324961|Secondary|Time to Protocol-defined Complete Response Over a 104-week Treatment Period|Time to response was defined as the time to participants achieving protocol-defined complete response at week 104 from baseline. Protocol-defined complete response was an HBV DNA level ≤ 300 copies/mL by Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart.|Baseline to Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||days||Standard Deviation|Mean
1273763|NCT00324961|Secondary|Number of Participants Achieving Complete Response at Week 104|Complete response was defined as an HBV DNA level ≤ 300 copies/mL by the Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart.|Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
1273764|NCT00324961|Secondary|Number of Participants Achieving HBV DNA ≤300 Copies/mL Over Time|Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory.|Weeks 13, 26, 39, 52, 65, 78, 91, and 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once. Missing data were not included in statistical analysis.|||participants|||Number
1273765|NCT00324961|Secondary|Number of Participants With ADV-associated Resistance at Week 104|Week 104 serum samples from participants who reached a HBV DNA breakthrough were assessed for the development of ADV (Adefovir dipivoxil) mutations (N236T and A181V) in the HBV polymerase. HBV DNA breakthrough was defined as an increase in HBV DNA level by 1 log10 copies/mL or more from the treatment nadir during Weeks 0 to 104.|Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
1273766|NCT00324961|Secondary|Number of Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 104|HBsAg loss and HBsAg seroconversion (HBsAg loss and HBsAb detected) were assessed for all participants who were HBeAg negative at Weeks 0 and 104. Confirmed HBsAg loss was defined as undetectable HBeAg.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once|||participants|||Number
1273767|NCT00324961|Secondary|Number of Participants Achieving ALT Normalization at Week 104|Serum alanine aminotransferase (ALT) normalization was defined as a serum ALT level at or below the upper limit of the normal (ULN) range after a baseline value above the ULN, as determined using central laboratory ranges.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once. A total of 435 participants had a baseline ALT value above the ULN.|||participants|||Number
1273769|NCT00324961|Secondary|Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks|The Knodell/histological activity index (HAI) scoring system that represents the sum of scores for periportal bridging necrosis (0–10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0–4: none=0, marked=4); portal inflammation (0–4: none=0, marked=4) and fibrosis (0–4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two independent pathologists in the HBeAg negative participants with 2 sequential liver biopsies during the period of 104 weeks.|Baseline to Week 104|HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 48|||Points on a scale||Standard Deviation|Mean
1273770|NCT00324961|Secondary|Number of Participants Achieving Histological Improvement After the 104-week Treatment|Histological improvement (defined as ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was assessed by 2 independent pathologists in the HBeAg-negative participants who underwent 2 sequential liver biopsies at baseline and week 104/withdrawal. The Knodell/histological activity index (HAI) scoring system represents the sum of scores for periportal, bridging necrosis (0–10: none=0, multilobular necrosis=10), interlobular degeneration and focal necrosis (0–4: none=0, marked=4), portal inflammation (0–4: none=0, marked=4), and fibrosis (0–4: none=0, cirrhosis=4)|Week 104|HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 104|||participants|||Number
1273771|NCT00324961|Primary|Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104|Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg participants who actually received the study medication at least once. Participants with missing data were not included in the analysis.|||participants|||Number
1273772|NCT00324896|Secondary|WASO|Wake after sleep onset in minutes|6 weeks|intent to treat|||minutes||Standard Deviation|Mean
1273773|NCT00324896|Primary|TST|Total sleep time in hours|6 weeks|intent to treat approach|||hours||Standard Deviation|Mean
1273774|NCT00324870|Other Pre-specified|Clinical Response Rate of SAHA and Bevacizumab|To determine the clinical response rate of SAHA and Bevacizumab in patients with metastatic renal cell carcinoma.|7 years|||||||
1273775|NCT00324870|Other Pre-specified|Maximum Tolerated Dose|Determine the maximum tolerated dose of SAHA|18 months from first patient dosing|||||||
1273776|NCT00324870|Primary|Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) (Phase II)|Estimated by Kaplan-Meier method|At 6 months|Progression free survival was summarized for the entire sample (n=37). The median survival times and 6-month survival rates are estim. based on the KP curve,w/ corresp. 95% confidence intervals using the log-log method. Conducted in SAS v9.3(Cary, NC). Progr.free survival time is calc. from date of first tx until date of progres./death or last fu.|||percent||95% Confidence Interval|Number
1273777|NCT00324857|Secondary|To Examine and Compare the Effectiveness of the Proposed Intervention Strategies to Increase AA Patient Likelihood of Receiving Knee Replacement Within 12 Months of the Intervention.||12 months|The data were not collected and therefore not analyzed.||||||
1273778|NCT00324857|Primary|Change in Willingness.|"Change in willingness assessed using the willingness likert scale. The primary outcome was change in patient willingness to undergo total knee replacement. The willingness rating is a 5-category ordinal response scale from definitely not willing to definitely willing which was later dichotomized for analysis. Responses definitely and probably willing were combined and compared to unsure, probably not willing, and definitely not willing combined."|Follow-Up|Study sample reflects the African American, predominantly male population of the VA health care system|||participants|||Number
1273779|NCT00324805|Other Pre-specified|To Determine Whether Smoking Status is Linked to Outcome for Patients With Resected Stage IB – IIIA NSCLC Treated With Chemotherapy With or Without Bevacizumab in the Adjuvant Setting.||From registration to death, up to 10 years|Data were not collected||||||
1273780|NCT00324805|Other Pre-specified|Perform Analyses of Tissue and Blood to Establish Factors That Predict for Clinical Outcome in Patients Receiving Chemotherapy, With or Without Bevacizumab, for Resected Early Stage NSCLC.||From registration to death, up to 10 years|Data for these studies were not collected||||||
1273781|NCT00324805|Other Pre-specified|Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|If the difference in the rate of a particular category of toxicities between the 2 arms (N=750 per arm) is at least 5% (4% vs. 9%), 96% power can be attained assuming a significance level of 5% (two-sided Chi Square test) and that the lower toxicity rate for one arm is 4%. A difference in the rates of grade 3-5 arterial thromboembolic events and bleeding events will be monitored and assessed between the treatment arms.|Up to 1 year post-treatment|||||||
1273782|NCT00324805|Secondary|Disease-free Survival|Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment.|From registration to death, up to 10 years|All enrolled patients|||months||95% Confidence Interval|Median
1273783|NCT00324805|Primary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint.|From registration to death, up to 10 years|All enrolled patients|||months||95% Confidence Interval|Median
1273784|NCT00324753|Primary|Communication Content|PCP Explains CRC screening to my satisfaction|immediately after the patient visit||||Participants|||Count of Participants
1273785|NCT00324753|Primary|Quality of Communication|Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).|immediate after the patient visit||||Participants|||Count of Participants
1273809|NCT00324649|Secondary|Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL||48 weeks|Treated participants. Missing values were treated as failure (i.e., as HIV-1 RNA greater than or equal to 50 copies/mL).|||Percentage of participants|||Number
1273786|NCT00324753|Primary|Completion of Colorectal Cancer Screening Tests|A survey collected data on patient demographic characteristics, family history of colorectal cancer or polyp, and provider recommendation for colorectal cancer screening, if any. In addition, we asked patients whether colorectal cancer screening was discussed at the visit. If the response was yes, we then asked patients how satisfied they were with the PCP communication during the visit in general using a 5-point Likert scale to a number of items describing the communication. A medical record review was conducted to collect data on provider ordering and patient completion of the following colorectal cancer screening tests during the study period (i.e., 6 months from the time of the clinical encounter): fecal occult blood testing, sigmoidoscopy, or colonoscopy.|6-12 months||||Participants|||Count of Participants
1273787|NCT00324740|Primary|Objective Response Rate|The phase II portion of the study ended early therefore the primary outcome of the objective response rate was not assessed.|Tumor measurements every 8 weeks until disease progression|||||||
1273788|NCT00324740|Primary|Maximum Tolerated Dose of Vorinostat in Combination With Isotretinoin|Hematologic: Any Grade 3/4 Thrombocytopenia and/or Grade 3/4 Neutropenia Non-Hematologic: Any >/= Grade3 non-hematologic toxicity considered by the investigator to be possibly related to study drug and/or any non-hematologic toxicity that results in a dose-delay of more than three weeks.|Once 2 DLT events occur in patients, the preceding dose will be designated the maximum tolerated dose (MTD).|The recommended phase II dose is vorinostat (300 mg bid) + Isotretinoin (0.5 mg/kg PO bid) three days per week|||mg/kg BID|||Number
1273789|NCT00324740|Primary|Dose Limiting Toxicities Associated With Vorinostat Concurrently Administered With Isotretinoin|Defined as the occurrence of one or more of the following toxicities as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Course 1, up to 28 days||||participants|||Number
1273790|NCT00324701|Secondary|SCID: Structured Clinical Interview for the DSM-IV|Structured clinical interview for the DSM-IV (SCID) administered by raters blind to subject condition. Structured interviews included psychiatric assessment for depression, PTSD, panic, generalized anxiety disorder (GAD) evaluated using the DSM-IV.|12 months|Participants completing 12 month assessment|||% participants with treatment response||95% Confidence Interval|Number
1273791|NCT00324701|Primary|At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)|The Geriatric Depression Scale (GDS) is a 30-item self-report assessment designed specifically to identify depression in the elderly. Participants are asked to respond by answering yes or no in reference to how they felt over the past week. Higher scores indicate more severe depression.|8 week & 12 months|Participants completing 8 week and 12 month assessments.|||% participants with treatment response||95% Confidence Interval|Number
1273792|NCT00324675|Secondary|HbA1c||at baseline and after 6 and 12 mo|||||||
1273793|NCT00324675|Secondary|Adverse Event||every month or at occurence|||||||
1273794|NCT00324675|Secondary|Renal Function||at abseline and after 6 and 12 mo|||||||
1273795|NCT00324675|Secondary|Renal Hemodynamic||at baseline and after 6 and 12 mo of tretament|||||||
1273796|NCT00324675|Primary|Proteinuria||at baseline and after 6 and 12 mo of treatment|per protocol|||g/24hr||Standard Error|Mean
1273797|NCT00324649|Secondary|Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.||48 weeks|Treated participants.|||Percentage of participants|||Number
1273798|NCT00324649|Secondary|Percentage of Participants With Any Adverse Event|"Participants with treatment-emergent adverse events were analyzed. Adverse events were defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with study treatment, and were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Version 11.~Treatment-emergent adverse events were events that met one of the following criteria:~Began or worsened in severity or relationship to study drug, on or after the date of the first dose of study drug and on or before the date of the last dose of study drug plus 30 days.~Had no recorded start date."|72 weeks|Treated participants.|||Percentage of participants|||Number
1273799|NCT00324649|Secondary|Change From Baseline in Waist Circumference/Hip Circumference Ratio|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded. Assessment of waist and hip circumference was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.|||Ratio||Inter-Quartile Range|Median
1273800|NCT00324649|Secondary|Percent Change From Baseline in Hematocrit|Change = Week 48 value minus baseline value expressed as median percent change.|Baseline to Week 48|Treated participants. Missing values were excluded.|||Percent change in hematocrit||Inter-Quartile Range|Median
1273801|NCT00324649|Secondary|Change From Baseline in Hemoglobin|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||g/dL||Inter-Quartile Range|Median
1273802|NCT00324649|Secondary|Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mg/dL||Inter-Quartile Range|Median
1273803|NCT00324649|Secondary|Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mg/dL||Inter-Quartile Range|Median
1273804|NCT00324649|Secondary|Change From Baseline in Fasting Total Cholesterol|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mg/dL||Inter-Quartile Range|Median
1273805|NCT00324649|Secondary|Change From Baseline in Fasting Serum Triglycerides|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mg/dL||Inter-Quartile Range|Median
1273806|NCT00324649|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||cells/mm^3||Inter-Quartile Range|Median
1273807|NCT00324649|Secondary|Percentage of Participants With Virologic Failure|Virologic failure was defined as two consecutive HIV RNA values > 400 copies/mL.|48 weeks|Treated participants.|||Percentage of participants|||Number
1273808|NCT00324649|Secondary|Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL||48 weeks|Treated participants.|||Percentage of participants|||Number
1273810|NCT00324649|Secondary|Percentage of Days for Which Participants Were Compliant With Study Drug|Compliance = [1 - [(sum of days with a missed dose [per Question 6 study medication assessment questionnaire (SMAQ)])/(sum of days between SMAQ visits)]] *100 for visits with SMAQ data. An assessable visit is one where the number of missed days was reported [Question 6] and the number of days between SMAQ visits could be calculated.|Baseline to Week 72|Treated participants.|||Percentage of days with compliance||Inter-Quartile Range|Median
1273811|NCT00324649|Secondary|Change From Baseline in Lactate Concentration|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mmol/L||Inter-Quartile Range|Median
1273812|NCT00324649|Secondary|Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||Ratio||Inter-Quartile Range|Median
1273813|NCT00324649|Secondary|Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||Ratio||Inter-Quartile Range|Median
1273814|NCT00324649|Primary|Change From Baseline in Limb Fat at Week 48|Limb fat was measured by DEXA. Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Number of participants analyzed is those with baseline and post-baseline DEXA data. Last post-baseline observation carried forward (LOCF) method was used if the Week 48 limb fat value was missing.|||grams (g)||Inter-Quartile Range|Median
1273815|NCT00324415|Secondary|Objective Response Rate (Complete and Partial)|Number of participants with complete and partial responses based on the RECIST criteria|3 years following treatment discontinuation||||participants|||Number
1273816|NCT00324415|Secondary|Anogenital Human Papilloma Virus (HPV) Infection and Anal Cytology||6 months following treatment discontinuation|||||||
1273817|NCT00324415|Secondary|Incidence of Opportunistic Illnesses|Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment|1 year following treatment discontinuation||||participants|||Number
1273818|NCT00324415|Secondary|Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment|Change in absolute CD4 counts from start of treatment to 1 year after completion of study treatment|1 year following treatment discontinuation|The number of participants analyzed is the number for whom absolute CD4 count data were available at baseline at at 1 year after study completion|||cells/mm3||Full Range|Median
1273819|NCT00324415|Secondary|Toxicity|Delayed toxicities are defined as toxicities that occur over 90 days following treatment completion|90 days following treatment discontinuation||||events|||Number
1273820|NCT00324415|Secondary|Quality of Life|EORTC QLQ-C30 Global Score at 1 year. The EORTC QLQ-C30 is a validated questionnaire that evaluates quality of life. The global score is an overall score for quality of life that ranges from 0 to 100. Higher scores indicate between quality of life|1 year|The number of participants analyzed is the number of participants for whom quality of life questionnaires were completed at one year.|||units on a scale||Standard Deviation|Mean
1273821|NCT00324415|Secondary|Overall Survival|Percentage of participants who are alive at one year|1 year||||percentage of participants||95% Confidence Interval|Number
1273822|NCT00324415|Secondary|Colostomy-free Survival at 1 Year|Percentage of participants who are alive and have not had a colostomy|1 year||||percentage of participants||95% Confidence Interval|Number
1273823|NCT00324415|Secondary|Relapse-free Survival|Percentage of participants who are alive and have not experienced progressive disease and have not relapsed|1 year||||percentage of participants||95% Confidence Interval|Number
1273824|NCT00324415|Secondary|Progression-free Survival|Progression-free survival at 1 year is the percentage of patients who are alive and have not experienced progressive disease, defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions.|1 year||||percentage of participants||95% Confidence Interval|Number
1273825|NCT00324415|Primary|Local Failure Rate at 3 Years|Patients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders|3 years following treatment discontinuation||||participants|||Number
1273826|NCT00324350|Secondary|Number of Participants With > 2 cm of Height Loss|Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing >2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity|5 years|Among participants in the BONE ancillary study, 6,979 participants had at least one height measurement during follow-up and were included in these analyses.|||participants|||Number
1273827|NCT00324350|Primary|Number of Participants With at Least One Fall|At each annual visit starting in January 2006, participants were also asked about falling: “In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair?” Those who answered “yes” were also asked how many times they had fallen in the previous 12 months.|Average follow-up of 2.0 years|These analyses include results from the annual visits that occurred before Feb 5, 2008, the close of the intensive glycemia arm. Of those in the BONE ancillary study, 6,782 participants answered at least one question about falls.|||participants|||Number
1273843|NCT00324259|Primary|Clinical Benefit Rate (CR Plus PR Plus SD)|"Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0~CR = disappearance of all target lesions~PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter~SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease~SD is defined as lack of disease progression by 24 weeks."|24 weeks after start of treatment||||participants|||Number
1273844|NCT00324233|Secondary|Subjectively Measured Insertion of the Catheter|||||||||
1273845|NCT00324233|Secondary|Subjectively Measured Handling|||||||||
1273846|NCT00324233|Primary|Residual Urine Measured by Ultra Sound||2||||ml||Standard Deviation|Mean
1273828|NCT00324350|Primary|Number of Participants With at Least One Non-vertebral Fracture|The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.|Average follow-up of 3.8 years|As per protocol, pathological fractures, confirmed as occurring secondary to neoplasm, necrosis, or sepsis, and periprosthetic fractures were excluded (N=7). These analyses are limited to confirmed fractures that occurred on or before Feb 5, 2008, when the intensive glycemia intervention was ended.|||participants|||Number
1273829|NCT00324272|Secondary|Death.|Death was recorded as the number of participants who had died by the end of the study follow-up period (1st June 2010). Deaths were recorded as either being related to the primary disease (i.e. due to distant metastasis) or death due to another (unrelated) cause (e.g. myocardial infarction or cerebrovascular accident).|From day of surgery until end of study follow-up period (1st June 2010)||||Participants.|||Number
1273830|NCT00324272|Secondary|Disease Recurrence.|This was measured as either: 1. the number of participants with local recurrence; 2. the number of participants with in transit or regional recurrence; or 3. the number of participants with distant metastasis (but alive on 1st June 2010).|From date of surgery until end of study follow-up period (1st June 2010)||||Participants.|||Number
1273831|NCT00324272|Secondary|Post Operative Pain Score Measured on 1st Post-operative Day.|Pain score was recorded at 24 hours following the completion of surgery using a Visual Analogue Score (using a scale of 1 [no pain] to 10 [very severe pain]) which the patient was asked to record.|During the immediate post-operative period.||||Units on a scale.||Inter-Quartile Range|Median
1273832|NCT00324272|Secondary|Number of Patients With Post-operative Complications (Excluding Lymphoedema).|Complications were classified as being either 'Minor' (i.e. (managed without operation, prolonged hospital stay or readmission) or 'Major' (i.e. requiring surgical intervention or readmission to hospital). The number of patients with each 'Minor' and 'Major' complication were recorded.|Until wound healing complete.||||Participants|||Number
1273833|NCT00324272|Secondary|Length of Time Drains Remain in Situ.|The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.|From date of surgery until date of wound drain removal.||||Days||95% Confidence Interval|Median
1273834|NCT00324272|Secondary|Length of Hospital Inpatient Stay.|The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.|From date of surgery until date of discharge from hospital.|As the length of hospital stay was affected by numerous factors other than those related to the surgery itself (e.g. the patient's social circumstances), the results for this secondary outcome measure have not been presented.|||Days||Standard Deviation|Mean
1273835|NCT00324272|Primary|Post-operative Wound Drainage.|The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.|From date of surgery to date of wound drain removal (typically a period of approximately one week).||||ml||95% Confidence Interval|Median
1273836|NCT00324259|Post-Hoc|Metabolic Flare on FDG-PET/CT as Compared to Response||Baseline and 24 hours after administration of the first dose of estradiol|"The data was combined as the outcome was not based on comparison of the two groups but comparing the overall FDG-PET/CT metabolic flare to the overall responses.~10 participants were not evaluable because early toxicity prevented response assessment and the PET data was not considered technically adequate or not available in 8 participants."|||participants|||Number
1273837|NCT00324259|Secondary|Overall Survival (OS)||Until patient death|This outcome measure was not analyzed as the overall survival was not reported.||||||
1273838|NCT00324259|Secondary|Frequency of Response to Re-treatment With Estradiol for Patients Who Have a Secondary Response to an Aromatase Inhibitor After the First Response to Estradiol.||Every 3 months|At the time that the study was powered there was not any information on any patients who were re-treated with estradiol after having a secondary response to a aromatase inhibitor after the first response to estradiol.||||||
1273839|NCT00324259|Secondary|Frequency of Response to Re-treatment With the Same Aromatase Inhibitor That Immediately Preceded Treatment With Estradiol on Protocol.|Best overall response|12 weeks post-treatment termination|Only offered to patients experiencing clinical benefit on estradiol.|||participants|||Number
1273840|NCT00324259|Secondary|Quality of Life (FACT-B Mean Score)|"Surveyed using the multidimensional Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire~The FACT-B (version 4) questionnaire consists of 36 items with five-point scale, ranging from 0-4, where a total score ranges from 0-144 and higher scores indicate better QoL. The total FACT-B score is the sum of scores for five subscales including: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and specific breast cancer concerns (9 items)."|Day 28|25 out of 34 participants in Arm 1 and 23 out of 32 participants completed the FACT-B questionnaire at Day 28 (4 weeks).|||units on a scale||Standard Deviation|Mean
1273841|NCT00324259|Secondary|Quality of Life|"Surveyed using a 6 item estrogen adverse effect questionnaire (headaches, bloating, breast tenderness, retention of fluid, nausea, and vomiting).~Used a 5-point scale ranging from 0 (not at all) to 4 (very much).~The scores from the 6 estrogen adverse effect items were summed to produce a single score, ranging from 0-24, with higher scores indicating higher adverse effects."|Baseline and Day 28|27 out of 34 participants in Arm 1 and 22 out of 32 participants in Arm 2 completed both the baseline and Day 28 (4 week) 6 item adverse effect questionnaire.|||units on a scale||Standard Deviation|Mean
1273842|NCT00324259|Secondary|Progression-free Survival (PFS)|"Defined as the time from treatment initiation to disease progression or death.~Time of last observation for patients remaining in the study and the time at which dose reductions, study drug termination, and withdrawal of consent occurred were treated as censored data.~Indicated as number of participants who had not progressed at 12 weeks, 24 weeks, 36 weeks, and 48 weeks.~Progression per RECIST 1.0 = at least a 20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Up to 48 weeks||||participants|||Number
1273847|NCT00324168|Secondary|Subgroup Analysis Predicting Best Spectacle-corrected Visual Acuity (BSCVA) as Stratified by Categories of Infiltrate/Scar Size|Best-spectacle visual acuity (BSCVA) at 3 months from enrollment is stratified by categories of infiltrate/scar size and examined by treatment arm|3 months from enrollment||||logMAR||Standard Deviation|Mean
1273848|NCT00324168|Secondary|Subgroup Analysis of Best Spectacle-corrected Visual Acuity (BSCVA) by Categories of Infiltrate Depth|BSCVA measured in logMAR will be examined by categories infiltrate depth (categorized by depth percentage) by mean and standard deviation as well as in a regression model.|3 months from enrollment||||logMAR||Standard Deviation|Mean
1273849|NCT00324168|Secondary|Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Visual Acuity Group|Best spectacle-corrected visual acuity (BSCVA) for this subgroup analysis was measured in logMAR and then categorized by equivalent Snellen fractions|3 months from enrollment||||logMAR||Standard Deviation|Mean
1273850|NCT00324168|Secondary|Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Causative Organism|BSCVA measured in logMAR will be estimated by causative organism (either Nocardia spp, Streptococcus pneumoniae, Moraxella spp, or Pseudomonas aeruginosa). BSCVA will be examined for each causative organism by mean and standard deviation as well as in a regression model.|3 months after enrollment||||logMAR||Standard Deviation|Mean
1273851|NCT00324168|Secondary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR Using MIC (Minimum Inhibitory Concentration) to Moxifloxacin as a Covariate|Best spectacle-corrected visual acuity (BSCVA) for this outcome is measured in logMAR (logarithm of the Minimum Angle of Resolution) in which smaller values indicate better visual acuity. Minimum inhibitory concentration (MIC) to moxifloxacin was measured by E test and a log2-transformation of MIC was used in all analyses. In this analysis we add MIC to the model examining BSCVA at 3 months.|3 months after enrollment|The study population analyzed for this outcome includes only those study subjects for whom an MIC value was available.|||logMAR||95% Confidence Interval|Mean
1273852|NCT00324168|Secondary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|12 months from enrollment||||logMAR||95% Confidence Interval|Mean
1273853|NCT00324168|Secondary|Ocular Perforations||At the time of perforation||||participants|||Number
1273854|NCT00324168|Secondary|Time to Resolution of Epithelial Defect|This outcome measured time from enrollment to resolution of the epithelial defect in days for up to 21 days. For three weeks patients were examined every 3 days for size of epithelial defect until the defect was gone.|From enrollment up to 21 days||||days||Standard Deviation|Mean
1273855|NCT00324168|Secondary|Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
1273856|NCT00324168|Secondary|Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment||3 months from enrollment||||mm||95% Confidence Interval|Mean
1273857|NCT00324168|Primary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
1273858|NCT00324155|Secondary|Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs)|irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=Moderate adverse events (AEs); minimal, local or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Time to resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).|Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of study drug and had a specific event that resolved|||Weeks||95% Confidence Interval|Median
1273859|NCT00324155|Secondary|Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved|irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=moderate adverse events (AEs); minimal, local, or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).|Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of study drug and had this specific event|||Participants|||Number
1273860|NCT00324155|Secondary|Number of Participants With Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Hypersensitivity, Immune-related AEs/SAEs, and Inflammatory AEs/SAEs|AE=any new undesirable symptom, sign, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be drug-related. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Randomization=Day 1; start of treatment (first dose)=Week 1. Summarization time frame is from first dose to 70 days after last dose of study at time of 414 deaths.|Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of randomized ipilimumab or placebo and/or dacarbazine|||Participants|||Number
1273932|NCT00323609|Secondary|Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days|Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment.|30 days post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out.|||percentage of participants|||Number
1273861|NCT00324155|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley.|Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months|All randomized participants whose survival follow-up was current (defined as having died or last known alive date occurring on or after the data cutoff date, which was when a total of 414 deaths occurred).|||Months||95% Confidence Interval|Median
1273862|NCT00324155|Secondary|Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff|Brain metastasis-free survival was defined as the time from randomization to the date of progression with a new lesion located in the brain. New brain lesions prior to Week 12 constituted a progression event (unlike main progression-free survival analysis). A participant who dies without documentation of a brain lesion was considered to have progressed with brain metastasis on the date of death. Participants who are free of brain metastasis were censored on the date of their last tumor assessment. An independent review committee evaluated images of participants with clinical symptoms to determine the number of those free of brain metastasis. The brain metastasis-free status was reported as a percent of participants (n/N), where n= participants with metastasis-free brains at data cutoff for the Primary Endpoint and N= randomized participants. A 2-sided Clopper and Pearson confidence interval was performed.|Date of randomization up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group|||Percentage of participants||95% Confidence Interval|Number
1273863|NCT00324155|Secondary|Duration of Stable Disease (SD): Randomized Participants With Stable Disease|Duration of SD was defined in those whose Best Overall Response (BOR) was SD, per independent review committee (IRC) as the time between Week 12 and date of progressive disease (PD) or death , whichever occurs first. For those who underwent tumor resection following Week 12 but prior to PD, duration of SD was censored on date of last evaluable tumor assessment (TA) prior to resection. For those with BOR of SD at Week 12, date of PD was used in analysis of duration of SD. For those with BOR=SD who have not subsequently progressed and who remain alive, duration of SD censored on date of last evaluable TA. Modified criteria of the World Health Organization (mWHO): SD=insufficient decrease to qualify for partial response or sufficient increase to qualify for PD; PD=an increase of 25% or more in sum of products of longest diameter and greatest perpendicular diameter of index lesions compared with smallest recorded sum, or appearance of 1 or more new lesions.|Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and had SD|||Months||95% Confidence Interval|Median
1273864|NCT00324155|Secondary|Time to Response: All Randomized Participants With Response to Treatment|Time to response was defined as the time between the first dose of study therapy and the date when measurement criteria were met for Best Overall Response (BOR) of partial response (PR) or complete response (CR), whichever occurred first, per independent review committee. Note that if an overall response of PR occurred before confirmation of CR, the time to response endpoint was not determined by the time that the BOR of CR was shown but rather by the earlier time point showing PR. Modified criteria of the World Health Organization: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline; PD=an increase of 25% or greater in the SPD of index lesions compared with the smallest recorded sum, or the appearance of 1 or more new lesions.|First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and who had a response of CR or PR|||Months||Full Range|Median
1273865|NCT00324155|Secondary|Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR)|DOR defined in those with Best Overall Response (BOR)=CR or PR per independent review committee (IRC) as time between date of response of confirmed CR or PR, whichever occurred first, and date of PD or death. If PR assessed before CR, DOR confirmed at earlier time-point showing PR. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions;no evidence of PD; PR=50% or greater decrease in the sum of products of longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline. PD=an increase of 25% or greater in SPD of index lesions compared with the smallest recorded sum, or appearance of 1 or more new lesions. Immune-related response criteria (irRC): SD=50% decrease in total measurable tumor burden compared with peak cannot be established nor 25% increase compared with nadir, in absence of unequivocal progression of nonindex lesions. Unconfirmed immune-related (ir) CR, irPR, or irPD=irSD.|Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and had a response of CR, PR, irCR, or irPR. n=number of participants who responded by mWHO criteria and irRC.|||Months||95% Confidence Interval|Median
1273866|NCT00324155|Secondary|Best Overall Response Rate (BORR)|BORR=number with Best Overall Response (BOR) of complete response (CR) or partial response (PR), divided by total number of randomized patients. BOR=date of first dose to the last tumor assessment prior to subsequent cancer therapy (including tumor resection surgery but excluding palliative local radiotherapy for bone lesions). Independent review committee assessment. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions; no evidence of progressive disease; PR=50% or greater decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline. Immune-related (ir) response criteria (irRC) assess tumor response in patients on immunotherapy: irCR=disappearance of all lesions in 2 consecutive observations at least 4 weeks apart; irPR=50% or greater decrease in total measureable tumor burden compared with peak in 2 observations at least 4 weeks apart.|First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group|||Percentage of participants||95% Confidence Interval|Number
1273876|NCT00324116|Secondary|Change From Baseline in Visual Acuity|Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.|Baseline, 6 weeks, 12 weeks, 54 weeks|FAS; n=number of subjects with evaluable data.|||score on scale||Standard Deviation|Mean
1273867|NCT00324155|Secondary|Progression-free Survival (PFS) Rate Truncated at Week 12|PFS rate=probability patient was progression-free at Day 78, calculated as total patients receiving treatment and with an overall response of stable disease (SD), partial response (PR), or complete response (CR) at Week 12, divided by total patients. For those alive and not progressed at or before Week 12, PFS censored on date of last evaluable tumor assessment (TA) at or before Week 12. Those with an assessment of PD prior to Week 12 and subsequent assessment of SD, PR, or CR at Week 12 were called progression-free at Week 12. Those with no recorded postbaseline TA dated on or before Day 109, and who had not died on or before Day 109, were censored at randomization. PD=at least 25% increase in sum of products of all index lesions or appearance of any new lesions. Both an investigator and independent review committee (IRC) assessed radiologic imaging studies, photographs of skin lesions, and clinical data. IRC assessment was considered primary over that of the investigators.|Day 78|All participants who were randomized to a treatment group|||Percentage of participants||95% Confidence Interval|Number
1273868|NCT00324155|Secondary|Median Number of Months of Progression-free Survival (PFS)|PFS=time between randomization and date of progression or death, whichever occurs first. Participants who died without reported prior progression were considered to have progressed on date of death. For those alive and not progressed, PFS was censored on date of last evaluable tumor assessment (TA). Those who have not died and have no recorded postbaseline TA were censored at randomization. Those who died without any recorded postbaseline TA were considered to have progressed on date of death. Evaluation was conducted by both investigator and an independent review committee (IRC), who assessed radiologic imaging studies, photographs of skin lesions, and clinical data. Progressive disease defined using modified criteria of the World Health Organization: demonstration of at least a 25% increase in the sum of products of all index lesions or the appearance of any new lesions. For nonindex lesions: appearance of any new lesions or unequivocal progression of nonindex lesions.|Randomization to date of progression or death to approximately 5 years|All participants who were randomized to a treatment group|||Months||95% Confidence Interval|Median
1273869|NCT00324155|Secondary|Disease Control Rate (DCR)|DCR=number whose best overall response (BOR) was partial response (PR), complete response (CR) or stable disease (SD), divided by all randomized participants (unevaluable participants included). Independent review committee assessment. BOR=date of first dose to last tumor assessment prior to subsequent cancer therapy (including tumor resection, excluding palliative local radiotherapy). Modified World Health Organization criteria: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline; SD=neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD; PD=at least 25% increase in sum of products of all index lesions and/or appearance of any new lesions; nonindex lesions: appearance of any new lesions and/or unequivocal progression of nonindex lesions.|First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years)|All participants who were randomized to a treatment group|||Percentage of participants|||Number
1273870|NCT00324155|Secondary|Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years|The survival rate (percentage of participants alive) was defined as the probability that a participant is alive at 1 year (or 18 months, 2 years, or 3 years) following randomization and was estimated via the Kaplan-Meier method.|Date of randomization to 3 years following randomization|All participants who were randomized to a treatment group|||Percentage of participants||95% Confidence Interval|Number
1273871|NCT00324116|Secondary|Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).|Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.|Baseline, 54 weeks or at early termination|FAS; n=number of subjects with evaluable data.|||score on scale||Standard Deviation|Mean
1273872|NCT00324116|Secondary|Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)|"Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54.~Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54."|54 weeks|FAS; n=77 (number of Subjects at Baseline with >20/200 Visual Acuity)|||participants|||Number
1273873|NCT00324116|Secondary|Number of Subjects With Severe Visual Loss|Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS|||participants|||Number
1273874|NCT00324116|Secondary|Number of Subjects Maintaining Vision|Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS|||participants|||Number
1273875|NCT00324116|Secondary|Number of Subjects Gaining Vision|Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS|||participant|||Number
1275131|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|8 weeks|Week 8 Data|||RMDQ Scale||Inter-Quartile Range|Median
1273877|NCT00324116|Primary|Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)|Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.|Baseline, 54 Weeks|The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.|||participants|||Number
1273878|NCT00324038|Primary|Average Daily Pain Scores - BS11 Pain Scores.|The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.|every day over a 12 week study duration.||||Box Scale 11 boxes||Standard Deviation|Mean
1273879|NCT00323882|Secondary|Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants|HAHA was measured by electrochemiluminescent (ECL) immunoassay for the detection of antibodies in human heparin plasma. Testing was performed on Days 1 (prior to ipilimumab infusion), 64, 85, and at completion of treatment.|Day 1 up to 2 years|All participants in the study who received either ipilimumab or radiation and had a measurement were analyzed.|||participants|||Number
1273880|NCT00323882|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants|12 Lead Electrocardiograms (ECGs) were performed at screening (Day -28 to Day -1), and on Day 85 during a treatment cycle, and at the end of treatment period. Clinically significant abnormalities could include atrial fibrillation, anterior fascicular block, marked sinus bradycardia, possible lateral infarct, and T-wave abnormality (other potential abnormalities were not excluded from consideration).|Baseline up to 2 years|All participants in the study who received either ipilimumab or radiation and had an ECG were analyzed.|||participants|||Number
1273881|NCT00323882|Secondary|Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants|CTC v3.0 used. On-study serum chemistry laboratories were reported after first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Alanine Aminotransferase (ALT) Units per Liter (U/L) Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST) U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Total Bilirubin micromoles per liter (µmol/L): Gr 1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Amylase U/L: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN. Creatinine µmol/L: Gr1: > 1.0 - 1.5*ULN; Gr2: > 1.5 - 3.0*ULN; Gr3: > 3.0 - 6.0*ULN; Gr4: > 6.0*ULN.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.|||participants|||Number
1273882|NCT00323882|Secondary|Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants|NCI CTC version(v) 3.0 was used to determine Grade (Gr). Screening was Day -28 to Day -1. On-study laboratories were reported after the first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Hemoglobin grams per liter (g/L): Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. White blood cells(WBC) 10^9 cells per liter (c/L): Gr1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Lymphocytes (absolute) 10^9 c/L: Gr1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Neutrophils (absolute) 10^9 c/L: Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Platelets 10^9 c/L: Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.|||participants|||Number
1273883|NCT00323882|Secondary|Overall Survival at Completion of Follow Up Period - Treated Participants|Overall Survival (OS) was defined as the time from the first date of study treatment until the date of death and was measured in months. For those participants who have not died, OS was censored at the last date the participant was known to be alive. Completion of follow-up for OS was a minimum time of eligibility 54 months to a maximum of 85 months.|Day 1 to 5 years post treatment|All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab were analyzed.|||Months||95% Confidence Interval|Median
1273884|NCT00323882|Secondary|Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants|Primary analysis was conducted on data from Day 1 up to 2 years post treatment, data available as of September 2009. Final Follow-Up analysis was conducted on data up to 5 years post treatment, data available as of September 2013 (minimum time of eligibility 54 months to a maximum of 85 months). Primary causes of deaths are listed under each timepoint.|Day 1 to 5 years post treatment|Treated participants population included all participants in the study who received either ipilimumab or radiation.|||participants|||Number
1273914|NCT00323635|Primary|Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;|Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.|2 months|No data collected or analyzed for the outcome measures.||||||
1273933|NCT00323609|Primary|Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months||24 months|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 24-months is indicated.|||percentage of participants|||Number
1273885|NCT00323882|Primary|Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants|Response by investigator using National Cancer Institute (NCI) PSA Working Group recommendations= PSA < 50% of PSA reference value occurring on or before Day 85; response confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. Complete response (CR)=PSA < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; Partial response (PR)=PSA ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; Stable disease(SD)=No change from PSA reference; Progressive disease (PD) defined: If PSA nadir was ≥ 100% of the reference: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.|Day 85|PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.|||participants|||Number
1273886|NCT00323882|Secondary|PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy|PSA response rate was defined as the number of participants with a PSA response (PR or CR) divided by the total number of PSA evaluable participants. PSA response at Day 85, as reported by the investigator, was defined as a PSA concentration < 50% of the PSA reference value occurring on or before Day 85 and this response was confirmed at least 4 weeks after the first determination. The PSA reference value was the PSA concentration measured immediately prior to treatment. Overall Response is < 50% of the PSA reference value occurring anytime after treatment was initiated and this response was confirmed at least 4 weeks after the first determination. Complete response=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after first value; Partial response=PSA concentration ≤ 50% of PSA reference value, confirmed at least 4 weeks after first determination.|Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.|||percentage of participants||95% Confidence Interval|Number
1273887|NCT00323882|Secondary|Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy|Tumor response rate was defined as the number of participants with a best response of partial or complete response divided by the total number of tumor evaluable participants. Overall Tumor Response was defined as participants with a tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.|||percentage of participants||95% Confidence Interval|Number
1273888|NCT00323882|Secondary|Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85|Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.|Day 1 to Day 85|All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab, had a baseline PSA, and had a confirmed Complete Response (CR) or Partial Response (PR) at Day 85.|||Months||Full Range|Median
1273889|NCT00323882|Secondary|Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants|For those with measurable disease, tumor response based upon tumor lesions (per investigator) using Response Evaluation Criteria in Solid Tumors (RECIST). Best Overall=Participants with a best tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met; Unconfirmed=not confirmed by repeat measurements; SD=Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 to last day of study treatment (+70 days) up to 2 years|Tumor-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had measurable disease at baseline, were analyzed.|||participants|||Number
1273890|NCT00323882|Secondary|Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants|Best Overall PSA response per investigator, using NCI PSA Working Group: PSA with CR or PR at any time after treatment initiation and was confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. CR=PSA concentration < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; SD=No change from PSA reference value; PD = If PSA nadir was ≥ 100% of the reference value: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference value: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference value: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.|Day 1 to last day of study treatment (+70 days) up to 2 years|PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.|||participants|||Number
1273931|NCT00323609|Secondary|Change in Anterior Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Anterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.|||mm|treated vertebrae|Standard Deviation|Mean
1273891|NCT00323882|Primary|Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants|AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AE (irAE) was defined as a clinically significant AE of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism. Day 1=first day of study treatment.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation were analyzed.|||participants|||Number
1273892|NCT00323869|Secondary|Overall Survival (OS) at 24 Months|Number of subjects surviving 2 years after treatment initiation|24 months|Includes all subjects who initiated treatment|||participants|||Number
1273893|NCT00323869|Secondary|Overall Survival (OS) at 12 Months|Number of subjects surviving 1 year after treatment initiation|12 months|Includes all subjects who initiated treatment|||participants|||Number
1273894|NCT00323869|Secondary|Time-to-First Event|Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation|18 months|Includes all subjects who initiated treatment|||months||95% Confidence Interval|Median
1273895|NCT00323869|Secondary|Stable Disease (SD)|Number of subjects with SD per RECIST criteria|6 weeks|Includes all subjects who initiated treatment|||participants|||Number
1273896|NCT00323869|Secondary|Complete Response (CR)|Number of subjects with CR per RECIST criteria|6 weeks|Includes all subjects who initiated treatment|||participants|||Number
1273897|NCT00323869|Secondary|Partial Response (PR)|Number of subjects with PR per RECIST criteria|6 weeks|Includes all subjects who initiated treatment|||participants|||Number
1273898|NCT00323869|Secondary|Overall Survival (OS)|To evaluate the safety of the combination regimen.|36 months|Includes all subjects who initiated treatment|||months||95% Confidence Interval|Median
1273899|NCT00323869|Secondary|Response Rate (CR + PR + SD)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE~Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.~Complete Response (CR) = disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions~Stable Disease (SD): No significant effect, does not meet criteria for PR or PD."|6 weeks|Includes all subjects who initiated treatment|||participants|||Number
1273900|NCT00323869|Primary|Progression-free Survival (PFS)|Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.|18 months|Includes all subjects who initiated treatment|||months||Full Range|Median
1273901|NCT00323739|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||Months||95% Confidence Interval|Median
1273902|NCT00323739|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease||18 months||||Months||95% Confidence Interval|Median
1273903|NCT00323635|Other Pre-specified|Sleep / Wake Pattern|Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.|Two weeks|No data collected or analyzed for the outcome measures.||||||
1273904|NCT00323635|Secondary|Pads Used|Pads used|Duration of Study|No data collected or analyzed for the outcome measures.||||||
1273905|NCT00323635|Secondary|Whether She Used Any Pads.|Yes/No|Duration of Study|No data collected or analyzed for the outcome measures.||||||
1273906|NCT00323635|Secondary|Hyperarousal|Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.|At baseline and 8 weeks later|No data collected or analyzed for the outcome measures.||||||
1273907|NCT00323635|Secondary|Cognitive Function|Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color)|Two 20-minute sessions during 2 months|No data collected or analyzed for the outcome measures.||||||
1273908|NCT00323635|Secondary|Sleep Quality||2 months|No data collected or analyzed for the outcome measures.||||||
1273909|NCT00323635|Secondary|Quality of Life, Scores on the Women's Health Questionnaire.|Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes.|2 weeks|No data collected or analyzed for the outcome measures.||||||
1273910|NCT00323635|Secondary|Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;|State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.|2 weeks|No data collected or analyzed for the outcome measures.||||||
1273911|NCT00323635|Primary|Relationship of Incontinence to Urge or Stress|4-grade scale|Duration of study|No data collected or analyzed for the outcome measures.||||||
1273912|NCT00323635|Primary|Number of Incontinence Episodes;|Number|Duration of Study|No data collected or analyzed for the outcome measures.||||||
1273913|NCT00323635|Primary|Urgency|Level of urgency for 7 days, graded 1 to 4,|Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;|No data collected or analyzed for the outcome measures.||||||
1275669|NCT00309387|Secondary|Number of Participants Undergoing Cataract Surgery|number of participants undergoing cataract surgery in at least one eligible eye during follow-up|at 6 month intervals from baseline for approximately 10 yrs|intention to treat|||participants|||Number
1273915|NCT00323622|Secondary|Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) Parasitemia|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|At Months 33 (M33) and 45 (M45) (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||Subjects|||Number
1273916|NCT00323622|Secondary|Number of Subjects With Anemia.|Anemia was indicated by a hematocrit level (HL) below (<) 25%. The numbers of subjects with HL below (<) and above or equal (≥) 25 %, and with missing HL results were tabulated. In the tabulation below, the number of subjects falling into the “HL ≥25%” category corresponds to the number of subjects with anemia as asked per outcome. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||Subjects|||Number
1273917|NCT00323622|Secondary|Number of Primary Case Definition Clinical Episodes of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI)|PFMI was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The number of PFMI episodes (EPFMI) per person-year (pyr) was tabulated, using as unit EPFMI episode per pyr. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||EPFMI episode per pyr|||Number
1273918|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 3|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 3 was defined as the presence of P. falciparum asexual parasitaemia above 15000 per microliter (µL) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||n/PYAR|||Number
1273919|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 2|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 2 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films in an unwell child brought for treatment with a history of fever (axillary temperature equal or above 37.5 degrees Celsius) within 24 hours or documented fever. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||n/PYAR|||Number
1273920|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 1|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 1 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||n/PYAR|||Number
1274815|NCT00317473|Primary|Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine|Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine|8 months||||events|||Number
1273921|NCT00323622|Secondary|Time to First or Only Clinical Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Primary Case Definition|Malaria infection by Plasmodium falciparum was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||n/PYAR|||Number
1273922|NCT00323622|Secondary|Anti-hepatitis B (HBs) Antibody Concentrations.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). Anti-HBs antibody concentration levels were measured in blood samples from Cohort 2 only.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens,with blood sample within protocol-defined time limits and available antibody measurements.|||mIU/mL||95% Confidence Interval|Geometric Mean
1273923|NCT00323622|Secondary|Anti-circumsporozoite Protein (CS) Antibody Concentrations.|Concentrations for anti-CS antibodies are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 0.5 EL.U/mL. Subjects were pooled across age ranges for this outcome measure.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens, with blood sample within protocol-defined time limits and available antibody measurements|||EL.U/mL||95% Confidence Interval|Geometric Mean
1273924|NCT00323622|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period: from Month 21 to Month 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the Total Vaccinated cohort, which included all subjects vaccinated in the primary NCT00197041 study, and re- enrolled in this follow-up NCT 00323622 study, and for whom data were available.|||Subjects|||Number
1273925|NCT00323609|Secondary|VCF-related Health Care Utilization|Health care utilization assessments conducted by monthly phone call to participating patients.|Monthly for 24 months post-op|Due to the early termination of the study, sponsor will not carry out the analysis of secondary healthcare utilization endpoints.||||||
1273926|NCT00323609|Secondary|Change in Global Sagittal Balance.|Change in global sagittal balance as measured by sagittal vertical axis.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Due to the early termination of the study and having few sites able to image using 3-foot lateral films, sponsor will not carry out the analysis of global sagittal balance in the clinic report.||||||
1273927|NCT00323609|Secondary|Change in Vertebral Body Local Cobb Angle (LCA)|The vertebral body local Cobb angle is a measurement of the 3-level functional unit consisting of the treated fractured vertebral body and the nearest adjacent vertebrae and is defined as the angle formed by lines drawn parallel to the superior endplate of the cranial adjacent vertebral body and the inferior endplate of the adjacent caudal vertebral body.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Local Cobb Angle' represents number of subjects with radiographic data available for analysis.|||degree|treated vertebrae|Standard Deviation|Mean
1273928|NCT00323609|Secondary|Change in Vertebral Body Kyphosis Angle|The vertebral kyphosis angle was defined as the angle formed by lines drawn parallel to the superior and inferior endplates of the treated fractured vertebral body.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Kyphosis Angle' represents number of subjects with radiographic data available for analysis.|||degree|treated vertebrae|Standard Deviation|Mean
1273929|NCT00323609|Secondary|Change in Posterior Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Posterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.|||mm|treated vertebrae|Standard Deviation|Mean
1273930|NCT00323609|Secondary|Change in Middle Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Middle Vertebral Body Height' represents number of subjects with radiographic data available for analysis.|||mm|treated vertebrae|Standard Deviation|Mean
1274816|NCT00317473|Primary|Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination|Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)|90 days||||events|||Number
1273934|NCT00323609|Secondary|Rate of Serious Adverse Events at 30 Days|Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.|30 days post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out.|||percentage of participants|||Number
1273935|NCT00323609|Secondary|Quality of Life -- EQ5D Index|EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.|||units on a scale||Standard Deviation|Mean
1273936|NCT00323609|Secondary|Quality of Life by SF-36|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.|||units on a scale||Standard Deviation|Mean
1273937|NCT00323609|Secondary|Back Function-Oswestry Disability Index|The Oswestry Disability Index (ODI) Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.|||units on a scale||Standard Deviation|Mean
1273938|NCT00323609|Secondary|Back Pain|Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).|7 days, 30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.|||units on a scale||Standard Deviation|Mean
1273939|NCT00323609|Primary|Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months||12 months|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 12-months is indicated.|||percentage of participants|||Number
1273940|NCT00323557|Primary|Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine|Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of >0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.|Baseline and at 1 month after vaccine.||||participants|||Number
1273941|NCT00323492|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48||48 weeks|ITT. Missing values were treated as failure.|||Percentage of participants|||Number
1273942|NCT00323492|Secondary|Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12||12 weeks|ITT. Missing values were excluded. Any subjects with plasma HIV-1 RNA greater than or equal to 400 copies/mL at Week 12 were to have virologic genotyping performed.|||Percentage of participants|||Number
1273943|NCT00323492|Secondary|Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12||12 weeks|ITT. Missing values were treated as failure.|||Percentage of participants|||Number
1273944|NCT00323492|Secondary|Change From Baseline to Week 48 in CD4 Cell Count|Change = Week 48 value minus baseline value.|Baseline to Week 48|ITT. Missing values were excluded.|||cells/mm^3||Inter-Quartile Range|Median
1273945|NCT00323492|Secondary|Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count|Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||cells/mm^3||Inter-Quartile Range|Median
1273946|NCT00323492|Secondary|Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12|Centralized laboratory assessment|12 weeks|ITT. Missing values were excluded.|||Percentage of participants|||Number
1273947|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)|Local laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded. Assessment of us-CRP was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.|||mg/L||Inter-Quartile Range|Median
1273948|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||Ratio||Inter-Quartile Range|Median
1273949|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||Ratio||Inter-Quartile Range|Median
1273950|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||mmol/L||Inter-Quartile Range|Median
1273951|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||mmol/L||Inter-Quartile Range|Median
1273952|NCT00323492|Primary|Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. LOCF method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.|||mmol/L||Inter-Quartile Range|Median
1273953|NCT00323492|Primary|Change From Baseline to Week 12 in Fasting Triglycerides|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Last post-baseline observation carried forward (LOCF) method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.|||mmol/L||Inter-Quartile Range|Median
1273954|NCT00323479|Secondary|Percentage of Participant With Therapeutic Maintenance Under Anastrozole|Treatment compliance. results based on 109 patients due to missing values|12 months||||percentage of participants|||Number
1273955|NCT00323479|Secondary|Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole|X ray assessment on hands and wrists based on 99 patients due to missing values|12 months||||millimeter||Standard Deviation|Median
1273956|NCT00323479|Secondary|Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole|X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values|12 months||||Units on scale||Standard Deviation|Mean
1273957|NCT00323479|Secondary|Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole|Results are based on 97 patients due to missing values|12 months||||Ng/mL||Standard Deviation|Mean
1273958|NCT00323479|Secondary|Functional Index of Cochin at 12 Months in Patients Under Anastrozole.|Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.|12 months||||Units on scale||Standard Deviation|Mean
1273959|NCT00323479|Primary|Number of Participants With New Events of Arthralgia||12 months||||Participants|||Number
1273960|NCT00323453|Primary|Post-operative Wound Infection, After Open Appendectomy|Wound infections will be documents in both the traditional retraction arm and the wound protections device arm. The severity of appendicitis between the two groups will be matched.|21 post operative days||||Participants|||Count of Participants
1273961|NCT00323427|Primary|Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Non-verbal Strategies subscale describe adaptive coping strategies but they describe unobtrusive, nonverbal behaviors that the individual can use to maximize communication effectiveness.~8 week change score from baseline value.~Larger values of the change score indicate more use of adaptive non-verbal behaviors.~Larger group mean change score indicates BETTER performance on this scale.~The CPHI Non-verbal strategies score ranges from 1 (worse) to 5 (better) usage of non-verbal strategies."|8-weeks post-baseline relative to baseline|Intent-to-Treat|||score on a scale.||Standard Deviation|Mean
1273962|NCT00323427|Primary|Communication Profile for Hearing Impaired: Verbal Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Verbal Strategies subscale describe adaptive strategies for coping with the effects of hearing impairment on communication.~8 week change score from baseline value.~Larger values of the change score indicate more use of adaptive Verbal Strategies.~Larger group mean change score indicates BETTER performance on this scale.~CPHI Verbal Strategies scores vary from 1 (worse) to 5 (best) strategy usage."|8 weeks post-baseline relative to baseline|Intent to treat|||score on a scale||Standard Deviation|Mean
1273963|NCT00323427|Primary|Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Maladaptive strategies subscale describe behaviors that prevent the individual from coping effectively with communication problems.~8 week change score from baseline value. Larger values of the change score indicate less use of maladaptive behaviors. Larger group mean change score indicates BETTER performance on this scale.~CPHI Maladaptive strategies subscale ranges from 1 (better) to 5 (worse) maladaptive strategy usage."|8 weeks post-baseline relative to baseline|Intent-to-treat (ITT)|||score on a scale||Standard Deviation|Mean
1273964|NCT00323414|Secondary|HbA1C Levels|Hemoglobin A1c|48 weeks||||mg/dL||Standard Deviation|Mean
1273965|NCT00323414|Secondary|Blood Glucose Levels|Fasting blood glucose|48 weeks||||mg/dL||Standard Deviation|Mean
1273966|NCT00323414|Secondary|Alanine Amino Transferase (ALT) Levels|Alanine amino transferase (IU/dL) ay 48 weeks|48 weeks||||IU/dL||Standard Deviation|Mean
1273967|NCT00323414|Secondary|Aspartate Amino Transferase (AST) Levels|Aspartate amino transferase (IU/dL) at 48 weeks|48 weeks||||IU/dL||Standard Deviation|Mean
1273968|NCT00323414|Secondary|Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Values|Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.|48 weeks||||HOMA-IR index||Standard Deviation|Mean
1273969|NCT00323414|Primary|Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS)|The non-alcoholic fatty liver disease (NAFLD) activity score (NAS) is a score based on the liver biopsy. It represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8, with high scores indicating more activity.|48 weeks||||Participants|||Count of Participants
1273970|NCT00323362|Secondary|1-year Survival|Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.|3 years|The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.|||percentage of patients|||Number
1273971|NCT00323362|Secondary|Time to Progression||2 years|The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.|||months||Standard Deviation|Mean
1273991|NCT00323271|Primary|Pain Intensity|The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.|Baseline to Post Treatment (12 weeks)|Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates|||units on a scale||Standard Deviation|Mean
1273972|NCT00323362|Primary|Percentage of Patients Who Meet Critieria for Response|"Response is considered Partial Response or Complete Response as per RECIST criteria.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years|Fourteen subjects were evaluable for response. Three subjects were not assessed.|||percentage of patients who responded|||Number
1273973|NCT00323310|Primary|The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events||up to 72 hours post dose|Included all dosed patients (safety population).|||Participants|||Number
1273974|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273975|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273976|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273977|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273978|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately post dose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273979|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately post dose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273980|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273981|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273982|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
1273983|NCT00323297|Secondary|One Year Survival From the Start of Sildenafil Treatment.|The survival status of all participants who discontinued from the study, including those participants who discontinued during the double-blind phase, was to be assessed at one year post their Week 12 visit/ End of treatment visit.|One year from the time of starting sildenafil|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.|||Participants who died|||Number
1273984|NCT00323297|Secondary|One Year Survival Probability From the Start of Sildenafil Treatment.|The survival probability of all participants up to 1-year post start of Sildenafil treatment; for participants who were randomized to Sildenafil, this was the week 52 from randomization, and for participants who were originally randomized to Placebo group, this was the Week 64 from Baseline (Week 52 from Week 12, when the first dose of Sildenafil was administered to these participants). Those participants who discontinued from the study prior to 1 year after start of sildenafil were considered as censored at the time of discontinuation and those who discontinued from the study post 1-year after start of sildenafil were considered as censored at the time of 1-year post start of sildenafil.|One year from the time of starting sildenafil|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.|||Probability of death||90% Confidence Interval|Number
1273985|NCT00323297|Secondary|Change From Baseline in Borg Dyspnea Score at Week 12|"Borg dyspnea scale is a 10-point scale where following scores stands for severity of dyspnea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]);~(very slight);~(slight breathlessness);~(moderate); 4 (some what severe);~5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum]); and 10 (maximum)."|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach.|||Units on a scale||Standard Deviation|Mean
1273986|NCT00323297|Secondary|Clinical Worsening Events|"No survival analysis was carried out for the study due to very few events of clinical worsening. Hence, we present a summary of clinical worsening events instead.~Events of clinical worsening were categorized as (A). Death, (B). Heart/lung transplantation, (C). Hospitalization due to pulmonary arterial hypertension (PAH), and (D). Clinical deterioration of PAH requiring additional therapy."|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication.|||Participants|||Number
1273987|NCT00323297|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class; deterioration = increase in functional class, no change = no change in functional class.|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the LOCF approach.|||Participants|||Number
1273988|NCT00323297|Primary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12|6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.|Week 12|Intent-to-Treat (ITT) Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward (LOCF) approach. Statistical analysis was carried out on LOCF values.|||Meters||Standard Deviation|Mean
1273989|NCT00323284|Secondary|Efficacy|Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months|12 months|Intent to treat population using non-responder approach|||percent||95% Confidence Interval|Number
1273990|NCT00323284|Primary|Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds|Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months|12 months|Intent to treat analysis of all enrolled subjects using non-responder approach|||percent of subjects achieving endpoint||95% Confidence Interval|Number
1273992|NCT00323271|Primary|Pain Intensity|The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.|baseline||||units on a scale||Standard Deviation|Mean
1273993|NCT00323258|Secondary|Death in Intervention Patients Compared to Usual Care|Number of patients who died in each treatment group prior to the 6 month follow-up time point.|6 months||||participants|||Number
1273994|NCT00323258|Secondary|Percent of Patients Adherent to Statin Via Refill Records|"According to the local pharmacy records, the patient has had a supply of statin for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account.~% adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes"|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.|||percentage of patients with >or=75%|||Number
1273995|NCT00323258|Secondary|Percent of Patients Adherent to Beta-blocker Via Refill Records|"According to the local pharmacy records, the patient has had a supply of beta-blocker for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account.~% adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes"|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.|||percentage of patients with PDC >or=75%|||Number
1273996|NCT00323258|Secondary|Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records|Percent of patients in each group adherent to beta-blocker and statin for 6 months after discharge as assessed by refill records from the patient's pharmacy|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.|||percentage of participants|||Number
1273997|NCT00323258|Primary|Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months|Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist|6 months|Those participants alive and able to speak to pharmacist on 6 month follow up phone call. Missing (n=35)- Could not be reached: 12 intervention and 11 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Died during call period: 2 intervention and 1 usual care, refused to participate in call: 1 intervention and 5 usual care.|||percentage of participants|||Number
1273998|NCT00323193|Secondary|Impact of Weight on Quality of Life Survey (IWQOL)|Raw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life.|baseline and six months||||units on a scale||Standard Deviation|Mean
1273999|NCT00323193|Primary|Weight Measurement|Weight taken at the baseline assessment and again at the 6 month assessment|baseline and six months||||pounds||Standard Deviation|Mean
1274000|NCT00323115|Secondary|Immunohistochemistry|"Pathologic specimen obtained from patients who require of another surgical resection after vaccination will be examined to determine the characteristics of infiltrating tumor cells.~Paraffin sections of tumor specimen will be stained by immunohistochemistry with antibodies to identify the components of the inflammatory response. This specimen will be compared to the one obtained at the time of initial surgery and changes in inflammation and inflammatory cellular components will be noted."|Approximately 42 months|Number of patients with pre- and post-tumor tissue procured, to undertake a meaningful analysis of the tumor immunohistochemistry slides inflammatory cells was insufficient. No data was collected.||||||
1274001|NCT00323115|Secondary|Evaluation of T Cell Characteristics|Peripheral blood obtained before starting radiation/ temozolomide (TMZ), and at first and second leukapheresis will be used to do lymphocyte phenotyping. We will determine percentages of CD3+/CD8+/CD45RO+ (memory T-cells), CD3+/CD8+/CD28- (CD8 suppressor T cell phenotype), and CD4+/CD25+ cells at those 3 time points. An anti-human Foxp3 antibody will be used to determine if the CD4+/CD25+ cells are T regulatory cells (TREG) and how the compartmental shift correlates with immunoresponse by other immune parameters as well as to efficacy.|Before starting radiation/Temozolomide and at Day 7 and Day 42.||||percentage of cells||Standard Deviation|Mean
1274002|NCT00323115|Secondary|Number of Enzyme-linked Immunosorbent Spots (ELISPOT) - Correlation Between Immunological Parameters and Efficacy - Mean|Pre- and post-vaccine immune assay results (Tumor-specific T-cell Responses) are summarized on a continuous scale as mean.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)||||spots||Standard Deviation|Mean
1274003|NCT00323115|Secondary|Percentage of Tumor-specific T-cells - Correlation Between Immunological Parameters and Efficacy- Mean|Pre- and post-vaccine immune assay results (Tumor-specific T-cell Responses) are summarized on a continuous scale as median. IFN = interferon.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)||||percentage of cells||Standard Deviation|Mean
1274004|NCT00323115|Secondary|Frequency of CD4+ and CD8+ T Cells - the Proportion of Cells in the Parent Population Responding to Glioblastoma Multiforme (GBM) - Mean|Pre- and post-vaccine immune assay results (Tumor-specific T-cells ) are summarized on a continuous scale as mean.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)|proportion of cells responding to GBM; GBM = glioblastoma multiforme|||proportion of cells||Standard Deviation|Mean
1274005|NCT00323115|Secondary|Number of Enzyme-linked Immunosorbent Spots (ELISPOT) - Correlation Between Immunological Parameters and Efficacy - Median|Pre- and post-vaccine immune assay results (Tumor-specific T-cell Responses) are summarized on a continuous scale as mean.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)||||spots||Full Range|Median
1274006|NCT00323115|Secondary|Percentage of Tumor-specific T-cells - Correlation Between Immunological Parameters and Efficacy- Median|Pre- and post-vaccine immune assay results (Tumor-specific T-cell Responses) are summarized on a continuous scale as median.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)||||percentage of cells||Full Range|Median
1274007|NCT00323115|Secondary|Frequency of CD4+ and CD8+ T Cells - the Proportion of Cells in the Parent Population Responding to Glioblastoma Multiforme (GBM) - Median|Pre- and post-vaccine immune assay results (Tumor-specific T-cells ) are summarized on a continuous scale as median.|Day 7 (pre-vaccination) and Day 42 (post-vaccination).|proportion of cells responding to GBM; GBM = glioblastoma multiforme|||proportion of cells||Full Range|Median
1274008|NCT00323115|Secondary|Overall Survival Duration: Efficacy Parameters|Overall survival will also be followed. Survival will be assessed from the date of surgery to the date of patient death, due to any cause, or to the last date the patient was known to be alive.|Approximately 42 months|There were 4 patients alive when data collection ended, including the patient the longest overall survival.|||Months||Full Range|Median
1274009|NCT00323115|Secondary|Number of Participants With Significant Difference in Tumor Volume Size Pre- and Postvaccination: Neuroimaging and Tumor Assessment|Patients with evidence of evaluable enhancing disease on contrast-enhanced MRI performed within four weeks of study entry will be evaluated for response rate. Patients will be evaluated for objective tumor assessments by gadolinium-enhanced magnetic resonance imaging (Gd-MRI). Comparisons of objective assessments, excluding progressive disease, are based upon major changes in tumor size on the Gd-MRI compared to the baseline scan. Determination of progressive disease is based upon comparison to the previous scan with volumetric analysis.|baseline and 4 weeks||||Participants|||Count of Participants
1274010|NCT00323115|Secondary|Progression Free Survival (PFS)|Progression-free survival will be assessed for each patient as the time from surgery until the patient reaches objective disease progression by MRI criteria. Death will be regarded as a progression event in those patients that die before disease progression. Patients without documented objective progression at the time of the analysis will be censored at the date of their last objective tumor assessment. Since disease free survival and overall survival are secondary endpoints all patients will be followed until death or for a period of 5 years following enrollment.|Approximately 42 months||||Months||Full Range|Median
1274011|NCT00323115|Secondary|Number of Participants With Evaluable Data: Feasibility of Vaccination|To determine the feasibility of this approach, the investigators hypothesize that at least 2/3 of the patients included in the study will be evaluable, meaning that the participants would have received the 3 vaccinations with immunologic outcome parameters measured before and after vaccination. Therefore a maximum of 15 patients would be enrolled in the study to obtain 10 evaluable patients. If after enrolling 15 patients the investigators are unable to obtain 10 evaluable patients, the investigators would consider this approach not feasible.|Through enrollment, approximately 2 years||||Participants|||Count of Participants
1274012|NCT00323115|Secondary|Number of Adverse Events: Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination|Adverse events attributed to vaccination. Collected and attributed adverse events at each study visit; monitored participants for adverse events for two hours following vaccination procedure.|Until death or approximately 24 months after diagnosis|Participants were monitored for adverse events at each visit and observed for 2 hours after intranodal injections. Toxicities were graded using the Common Terminology Criteria for Adverse Events (version 3.0) and Common Toxicity Criteria (version 3.0).|||attributable adverse events|||Number
1274013|NCT00323115|Primary|Tumor-specific Cytotoxic T-cell Response|MRI & pheresis post vaccine|Day 42|All participants who received all 3 vaccine administrations were used in this data analysis.|||10^9 cells/L||Full Range|Median
1274014|NCT00323063|Secondary|Overall Survival||5 years|This study was prematurely closed so overall survival was not analyzed.||||||
1274015|NCT00323063|Secondary|Response Rate (Complete and Partial Response)|Overall response rate was evaluated every 2 cycles (six weeks) for both groups using international criteria by the Response Evaluation Criteria in Solid Tumors (RECISTv1.0) for target lesions and were assessed by CT or MRI. Response rates were defined as complete response (CR), disappearance of all target lesions; partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response(OR) defined as OR=CR + PR|5 years||||percentage of participants||95% Confidence Interval|Number
1274016|NCT00323063|Primary|Time to Progression|Sample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided).|5 years||||months||95% Confidence Interval|Median
1274017|NCT00323037|Secondary|Drug Compliance||Up to 32 weeks (titration and maintenance phases)|||||||
1274018|NCT00323037|Secondary|Safety and Tolerability of Coreg CR||24 weeks after entry into the maintenance phase (after unblinding)|||||||
1274019|NCT00323037|Secondary|Drug Dose Tolerability||Up to 32 weeks (titration and maintenance phases)|||||||
1274020|NCT00323037|Secondary|Hospitalizations From All Causes||Up to 32 weeks (titration and maintenance phases)|||||||
1274021|NCT00323037|Secondary|Incidence of Hospitalizations From Exacerbation of Heart Failure||Up to 32 weeks (titration and maintenance phases)|||||||
1274022|NCT00323037|Secondary|Change From Baseline in BNP Levels||24 weeks after entry into the maintenance period|||||||
1274023|NCT00323037|Secondary|Change From Baseline in Left Ventricular Remodeling (IVST, PWT, LVM, ESV, EDV, EDVI, ESD, EDD, Deceleration Time, and E:A Ratio)||24 weeks after entry into the maintenance period|||||||
1274024|NCT00323037|Secondary|Change From Baseline in Left Ventricular Ejection Fraction||24 weeks after entry into the maintenance period|||||||
1274025|NCT00323037|Primary|Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography|Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.|24 weeks after entry into the maintenance period|Analysis was performed on the modified intent to treat population (mITT), which were those subjects with both a Baseline and an evaluable End of Study echocardiogram.|||mL/m^2||Standard Deviation|Mean
1274026|NCT00322881|Primary|Therapy Completion Rate|The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.|6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
1274817|NCT00317473|Primary|Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination|Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period|40 days||||events|||Number
1274027|NCT00322868|Primary|Sputum IL-8|Concentration of Interleukin-8 log 10 (pg/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (pg/mL)||Standard Deviation|Mean
1274028|NCT00322868|Primary|Sputum IL-6|The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (pg/mL)||Standard Deviation|Mean
1274029|NCT00322868|Primary|Sputum IL-1ß|The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (pg/mL)||Standard Deviation|Mean
1274030|NCT00322868|Primary|Sputum TNFα|The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (pg/mL)||Standard Deviation|Mean
1274031|NCT00322868|Primary|Sputum Active Elastase|Log 10 of Concentration of active Elastase in mcg/mL|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (mcg/mL)||Standard Deviation|Mean
1274032|NCT00322868|Primary|Sputum Neutrophil Percent|Neutrophils as a percent of the total white cells.|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||Percent (%) of white blood cells||Standard Deviation|Mean
1274033|NCT00322868|Primary|Sputum Neutrophil Count|sputum neutrophils log 10 (cells/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (cells/mL)||Standard Deviation|Mean
1274034|NCT00322868|Primary|Sputum White Cell Count|The total number of white cells log 10 cells/mL|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (cells/mL)||Standard Deviation|Mean
1274035|NCT00322855|Primary|To Review the Outcome of Patients With Soft Tissue Sarcoma Treated With Chemotherapy From 2004 and 2005||up to one year|Study was terminated due to low accrual. This is not an applicable trial; no results to report||||||
1274036|NCT00322842|Secondary|Increase in Peripheral Blood (PB) CD34+ Cells From Steady-state Hematopoiesis to Pre-leukapheresis in G-CSF+Plerixafor Treated Participants Compared to Historical Controls Treated With G-CSF Alone or Chemotherapy and G-CSF|A comparison of the effectiveness in mobilizing peripheral blood CD34+ cells between this study's treatment regimen (G-CSF plus plerixafor) to other treatment options: G-CSF alone, and chemotherapy with G-CSF.|up to day 8|Analysis was not performed. Historical data was not available.||||||
1274037|NCT00322842|Other Pre-specified|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Participants who had transplants and engraftment data 12 months after transplantation|||participants|||Number
1274038|NCT00322842|Other Pre-specified|Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who had transplants. Fifteen participants had tandem transplants.|||number of transplants|Participants||Number
1274039|NCT00322842|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who had transplants. Fifteen participants had tandem transplants. The date of initial PMN engraftment was missing for 11 transplants, which were later shown to have durable grafts.|||number of transplants|Participants||Number
1274040|NCT00322842|Other Pre-specified|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median total number of CD34+ cells collected during apheresis as measured by a central lab.|Days 5-8|Intent to treat population. Samples from two participants were not analyzed by the central lab.|||CD34+ cells (*10^6 / kg)||Full Range|Median
1274041|NCT00322842|Secondary|Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL After First Dose of Plerixafor|The fold increase was measured using local lab values and is the ratio of post first dose (pre-apheresis) PB CD34+ cells/µL)/pre-plerixafor dosing PB CD34+ cells/µL)|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population|||ratio||Full Range|Median
1274058|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274042|NCT00322842|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 step scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population - all participants who received at least 1 dose of plerixafor.|||participants|||Number
1274043|NCT00322777|Secondary|Remission|Remission of depression was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). Remission was based on a HAM-D score of less than 7. Remission is indicated as a percentage of participants at each time point whose scores were below 7.|baseline, 8 weeks, 16 weeks, and 24 weeks||||percentage of participants score < 7|||Number
1274044|NCT00322777|Secondary|Response Rate|Response rate was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). A response was determined as a reduction in the HAM-D score by at least 50% from the baseline score. The data are presented as the percentage of participants with response at each time point as compared to baseline.|baseline, 8 weeks, 16 weeks, and 24 weeks||||percentage of participants with response|||Number
1274045|NCT00322777|Primary|Hamilton Depression Rating Scale - Depression Severity|"Depression severity was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a standardized outcome measure of depression severity in adults. Total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression.~The HAM-D was administered through a face to face interview, which was conducted by a trained nurse who was blinded to participants’ allocation."|baseline, 8 weeks, 16 weeks, and 24 weeks||||units on a scale||Full Range|Mean
1274046|NCT00322712|Primary|Time to Death|Length of survival of patients treated with a combination of Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week.|From date of treatment until time of death||||Months||Full Range|Median
1274047|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.|||kilograms (kg)||Standard Deviation|Mean
1274048|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.|||mm Hg||Standard Deviation|Mean
1274049|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.|||mm Hg||Standard Deviation|Mean
1274050|NCT00322621|Secondary|Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.|||beats per minute||Standard Deviation|Mean
1274051|NCT00322621|Secondary|Number of Participants Discontinuing in Maintenance / Rescue Phase||Baseline (Week 8) to Week 34|Participants in Maintenance / Rescue Phase (beyond Week 8 through Week 34)|||participants|||Number
1274052|NCT00322621|Secondary|Number of Participants Discontinuing in the Acute Phase||Baseline (Week 0) to Week 8|Participants in Acute Phase (through Week 8).|||participants|||Number
1274053|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274054|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274055|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint|This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274056|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint|This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).|Baseline (Week 8), Week 34|Number of responders with a baseline and ate least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274057|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274059|NCT00322621|Secondary|Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274060|NCT00322621|Secondary|Maintenance Arm: Patient’s Global Impressions of Improvement (PGI-I) at Week 34 Endpoint|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 34|Number of responders with at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274061|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274062|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274063|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274064|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274065|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274066|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274067|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274068|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274069|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274070|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274071|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274072|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274073|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274074|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274075|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274076|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274077|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274078|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274079|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274080|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274081|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274082|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274879|NCT00316719|Secondary|Time to Onset of HBeAg Loss|Time to onset with loss of HBeAg in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.|From Baseline to Week 52|||||||
1274083|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274084|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274085|NCT00322621|Secondary|Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 0), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||participants|||Number
1274086|NCT00322621|Secondary|Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 0), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||participants|||Number
1274087|NCT00322621|Primary|Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint|Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Patients entering maintenance phase on duloxetine 60 mg QD. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1274088|NCT00322556|Primary|Number of Subjects With Clinically Significant Changes in Vital Signs.|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Before, during, and after each infusion.|The Safety Data Set (SDS) comprised all subjects treated with the study drug.|||Participants|||Number
1274089|NCT00322556|Secondary|Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.|Mean IgG trough concentration. For this analysis, each subject’s values were first aggregated to their median and the median values were then analyzed.|Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.|The ITT data set comprised all subjects treated with the study drug for which serum IgG information was available.|||g/L||Full Range|Mean
1274090|NCT00322556|Secondary|Annualized Rate of Any Infection.|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Infections were classified as all AEs with the system organ class “infections and infestations” and AEs with the preferred term “conjunctivitis”."|For the duration of the study, up to approximately 29 months.|The ITT data set comprised all subjects treated with the study drug.|||Infections per subject year|Participants||Number
1274091|NCT00322556|Secondary|Number of Days of Hospitalization.||For the duration of the study, up to approximately 29 months|The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.|||Days||Full Range|Median
1274092|NCT00322556|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.||For the duration of the study, up to approximately 29 months.|The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.|||Days||Full Range|Median
1274093|NCT00322556|Secondary|Annualized Rate of Acute Serious Bacterial Infections.|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 29 months|The Intention-To-Treat (ITT) data set comprised all subjects treated with the study drug|||Infections per subject year|Participants||Number
1274094|NCT00322556|Primary|Rate of AEs by Severity and Relationship|"The AE rate was the number of AEs over the number of infusions administered.~Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities.~At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs."|For the duration of the study, up to approximately 29 months|The SDS comprised all subjects treated with the study drug.|||AEs per infusion|Participants||Number
1274107|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset|At all study visits, unsolicited adverse events were recorded.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
1276339|NCT00303862|Primary|Objective Response|Objective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)|Up to 6 weeks||||percentage of participants||95% Confidence Interval|Number
1274095|NCT00322556|Primary|Influence of Infusion Rate on Temporally-Associated AEs|"The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min).~AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion."|Within 72 hours after each infusion|'New subjects’ could receive IgPro10 at up to 4 mg/kg/min. 'Old' subjects (ie, those treated with the study drug who participated in a preceding, pivotal, Phase III clinical study with intravenous IgPro10 [study number ZLB03_002CR, NCT00168025]), could receive IgPro10 at up to 12 mg/kg/min at the discretion of the Investigator.|||Infusions|Participants||Number
1274096|NCT00322556|Primary|The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).|AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.|During each infusion, and within 48 or 72 hours after the end of each infusion.|The Safety Data Set (SDS) comprised all subjects treated with the study drug.|||Proportion of infusions|Participants||Number
1274097|NCT00322491|Other Pre-specified|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant. The one participant who did not have a durable graft at 12 months had received chemotherapy for relapse approximately 9 months after transplantation.|||participants|||Number
1274098|NCT00322491|Other Pre-specified|Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|A total of 47 participants were transplanted. Two participants in the MM group received a second transplant using cells collected on study. One participant in the MM group did not have PLT engraftment information recorded, however did report a durable graft at month 12 post transplant.|||number of transplants|Participants||Number
1274099|NCT00322491|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who received a transplant. Two participants in the MM group received a second transplant.|||number of transplants|Participants||Number
1274100|NCT00322491|Other Pre-specified|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median cumulative total number of CD34+ cells collected during apheresis.|Days 5-8|Participants who received at least one dose of plerixafor|||CD34+ cells (*10^6 / kg)||Full Range|Median
1274101|NCT00322491|Secondary|Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor|The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)|Days 4-5 (first dose of plerixafor to apheresis)|The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).|||participants|||Number
1274102|NCT00322491|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population – all participants who received at least 1 dose of plerixafor.|||participants|||Number
1274103|NCT00322465|Secondary|Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis|Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis|Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|||||||
1274104|NCT00322465|Primary|Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|"Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit.~Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs).~Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)"|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent to treat: all subjects randomized who received at least one dose of study drug therapy or placebo|||Percentage of participants|||Number
1274105|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
1274106|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
1274108|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis|Logistic multiple regression with independent variable selection based on single variable models with p<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.|||Participants|||Number
1274109|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis|Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.|||Participants|||Number
1274110|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis|Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures.|||Participants|||Number
1274111|NCT00322465|Secondary|Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment)|Baseline (enrollment)|All study participants with evaluable baseline test results.|||Percentage of participants|||Number
1274112|NCT00322465|Secondary|Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment)|Baseline (enrollment visit)|All study participants with evaluable baseline test results.|||Percentage of participants|||Number
1274113|NCT00322465|Secondary|Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment)|Baseline (enrollment visit)|All study participants with evaluable baseline test results.|||Percentage of participants|||Number
1274114|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.|||Percentage of participants|||Number
1274115|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.|||Percentage of participants|||Number
1274116|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.|||Percentage of participants|||Number
1274117|NCT00322465|Secondary|Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole)|"Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit.~Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 PMNs per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs).~Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)"|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Percentage of participants|||Number
1274118|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
1274119|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
1276340|NCT00303823|Primary|Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer||4 months||||participants|||Number
1274120|NCT00322452|Secondary|Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.|||Participants|||Number
1274121|NCT00322452|Secondary|Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.|||Participants|||Number
1274122|NCT00322452|Secondary|Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.|||Participants|||Number
1274123|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases|Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274124|NCT00322452|Secondary|Vomiting|Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274125|NCT00322452|Secondary|Nausea|Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274126|NCT00322452|Secondary|Diarrhoea|Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274127|NCT00322452|Secondary|Rashes/Acnes|Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274155|NCT00322374|Secondary|Epirubicin AUC(INF)|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=the area under the plasma concentration-time curve from time zero extrapolated to infinity of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||ng·h/mL||Standard Deviation|Mean
1274128|NCT00322452|Secondary|Neurotoxicity|Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274129|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia|Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274130|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia|Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274131|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia|Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274132|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia|Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
1274133|NCT00322452|Secondary|Objective Tumour Response Rate According to RECIST|Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.|Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).|Analysis was carried out on Intention-to-treat (ITT) population.|||Participants|||Number
1274134|NCT00322452|Secondary|Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)|Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here.|Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.|Analysis was carried out on Intention-to-treat (ITT) population.|||Months||95% Confidence Interval|Median
1274135|NCT00322452|Primary|Median Progression Free Survival (PFS) in Months|PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.|Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).|Analysis was carried out on Intention-to-treat (ITT) population.|||Months||95% Confidence Interval|Median
1274136|NCT00322439|Secondary|Percentage of Body Surface Area Affected by Psoriasis|Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||percentage of body surface area||Standard Error|Mean
1274156|NCT00322374|Secondary|Epirubicin Cmax|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||ng/ml||Standard Deviation|Mean
1276341|NCT00303823|Primary|No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia||4 months||||participants|||Number
1274137|NCT00322439|Secondary|Work Productivity and Activity Impairment (WPAI)|The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes).|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n), and who were employed (for the first 3 scores).|||units on a scale||Standard Error|Mean
1274138|NCT00322439|Secondary|Healthcare Resource Use|"This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:~How many times have you been to any physician’s office or urgent care clinic, not including your dermatologist?~How many times have you seen a nurse practitioner, physician assistant, psychologist, naturopath, acupuncturist, or chiropractor?~How many times have you received care from a health professional (HP) in your home?~How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)?~How many times have you had a friend or family member take time off work to provide care or transportation?"|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||times||Standard Error|Mean
1274139|NCT00322439|Secondary|Euroqol-5D (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||units on a scale||Standard Error|Mean
1274140|NCT00322439|Secondary|Euroqol-5D (EQ-5D) Total Score|EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered ‘3’ for all questions) to 1.0 (ie, answered ‘1’ for all questions), where 1.0 represents perfect health.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||units on a scale||Standard Error|Mean
1274141|NCT00322439|Secondary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||percentage of participants|||Number
1274142|NCT00322439|Secondary|Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1|The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).|Baseline and at 3 and 5 years|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||percentage of participants|||Number
1274143|NCT00322439|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|The sPGA scale is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|Baseline and at 3 and 5 years|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||percentage of participants|||Number
1274144|NCT00322439|Secondary|Five-year Cumulative Incidence for Events of Medical Interest (EMIs)|Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.|5 years|Full analysis set|||proportion of participants||95% Confidence Interval|Number
1274328|NCT00321763|Primary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.|From Day 0 to Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1274145|NCT00322439|Primary|Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events|A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor’s opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).|5 years||||proportion of participants||95% Confidence Interval|Number
1274146|NCT00322387|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Intent to treat population. Six participants with MM had 2 transplants.|||transplants|Participants||Number
1274147|NCT00322387|Secondary|Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL|The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.|||ratio||Standard Deviation|Mean
1274148|NCT00322387|Primary|Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant|Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.|13 months|Safety population who received at least one dose of plerixafor.|||participants|||Number
1274149|NCT00322374|Secondary|Number Of Participants With Tumor Response by Duration of Response Category|Duration of response was defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death; PR= ≥30% decrease in the sum of the longest diameter of target lesions.|Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.|||participants|||Number
1274150|NCT00322374|Secondary|Duration of Tumor Response|Defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death. CR= disappearance of all target lesions; PR= ≥30% decrease in the sum of the longest diameter of target lesions.|Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.|||months||Full Range|Median
1274151|NCT00322374|Secondary|Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease|Information on all tumor lesions was obtained at baseline by radiologic techniques, or if appropriate by physical examination (e.g. subcutaneous nodules). Measurable tumors were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, wherein complete response (CR) = disappearance of all target lesions; partial response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD)= ≥20% increase in the sum of the longest diameter of target lesions, and stable disease (SD) = small changes that do not meet above criteria.|From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.|||participants|||Number
1274152|NCT00322374|Secondary|Epirubicin Vss|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||liters||Standard Deviation|Mean
1274153|NCT00322374|Secondary|Epirubicin CLT|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||L/h||Standard Deviation|Mean
1274154|NCT00322374|Secondary|Epirubicin T-Half|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of epirubicin administered IV dose 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||hours||Standard Deviation|Mean
1274994|NCT00316017|Secondary|Presence of Nosocomial Infection Through Day 28|Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection|Within 28 days of injury, while hospitalized||||participants|||Number
1274157|NCT00322374|Secondary|Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||liters||Standard Deviation|Mean
1274158|NCT00322374|Secondary|Clearance (CLT) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||L/h||Standard Deviation|Mean
1274159|NCT00322374|Secondary|Terminal Half-life (T-Half) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||hours||Standard Deviation|Mean
1274160|NCT00322374|Secondary|Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||ng·h/mL||Standard Deviation|Mean
1274161|NCT00322374|Secondary|Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone|Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||ng/ml||Standard Deviation|Mean
1274162|NCT00322374|Secondary|Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event|Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.|All participants who received at least 1 cycle of therapy were evaluable for safety; adverse events and other symptoms were graded according to CTCAE Version 3.0.|||participants|||Number
1274163|NCT00322374|Primary|Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)|The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD.|Day 21 of Cycle 1|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and were observed for ≥21 days following the first dose or the participant experienced DLT.|||mg^m2|||Number
1274164|NCT00322374|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks|From Baseline to the end of Cycle 1 (Day 21)|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and was observed for ≥21 days following the first dose or the participant experienced DLT.|||Participants|||Number
1274165|NCT00322348|Secondary|Area Under the Plasma Concentration Curve (0-12 Weeks)|Area under the plasma concentration curve (0-12 weeks) derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the PK subgroup set|||ng/mL||Full Range|Geometric Mean
1274166|NCT00322348|Secondary|Time to Maximum Plasma Concentration, Tmax (Hours)|Time to maximum plasma concentration, Tmax (hours), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the PK subgroup set|||hours||Full Range|Geometric Mean
1275017|NCT00315731|Secondary|Overall Survival|Time to death is defined as the time from the dosimetric dose to the date of death.|Week 7 to Week 260 post treatment|ITT-E Population|||months||95% Confidence Interval|Median
1274167|NCT00322348|Secondary|Maximum Plasma Concentration, Cmax (ng/mL)|Maximum plasma concentration, Cmax (ng/mL), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the pharmacokinetic (PK) subgroup|||ng/mL||Full Range|Geometric Mean
1274168|NCT00322348|Secondary|Oestradiol (E2) Serum Concentrations at Week 24|A comparison of mean E2 serum concentrations at timepoint(s) post Day 1 performed using analysis of covariance (ANCOVA), with treatment group, baseline E2 serum concentrations and country as covariates. Data analysed on the log scale; log scale mean and pooled log scale standard deviation from Analysis of Covariance (ANCOVA) presented.|Blood samples for measurement of E2 concentrations collected from all patients at scheduled visits of screening, Day 1 and Weeks 12 and 24 (+/- 7 days). Week 24 data is presented||||pmol/L||Standard Deviation|Log Mean
1274169|NCT00322348|Secondary|Objective Response Rate (ORR) at Week 24|Number of participants who were objective responders at Week 24 over the number of participants evaluable for response x 100. An objective responder = a participants whose best unconfirmed response is either CR (Complete Response Disappearance of all target lesions) or PR (Partial Response At least a 30% decrease in target lesions)|Response Evaluation Criteria in Solid Tumours (RECIST) tumour assessments carried out every 12 weeks from randomisation until Week 24 in those patients with measurable disease at baseline.||||Percentage of participants|||Number
1274170|NCT00322348|Primary|Percentage of Participants With Progression Free Survival (PFS) at Week 24|The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.|Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).||||Percentage of participants|||Number
1274171|NCT00322335|Primary|Number of Subjects With Serious Adverse Events|Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)|Analysis was performed on the Total Cohort, which included all vaccinated subjects in the booster study (NC00323050) and who came back during the follow-up.|||subjects|||Number
1274172|NCT00322335|Primary|Anti-PSC Concentrations|Concentrations for anti-PSC antibody were expressed as GMCs.|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||µg/mL (microgram per milliliter)||95% Confidence Interval|Geometric Mean
1274173|NCT00322335|Primary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)|"The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
1274174|NCT00322335|Primary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)|"The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
1274175|NCT00322335|Primary|Anti-PRP Concentrations|Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||µg/mL (microgram per milliliter)||95% Confidence Interval|Geometric Mean
1274176|NCT00322335|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)|The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
1274177|NCT00322335|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)|The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
1274178|NCT00322335|Primary|rSBA-MenC Titers|"Titers are expressed as Geometric Mean Titers (GMTs).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||titer||95% Confidence Interval|Geometric Mean
1274179|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128|"The cut-off value for the rSBA-MenC titers was equal to or above 1:128.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
1274180|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32|"The cut-off value for the rSBA-MenC titers was equal to or above 1:32.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
1274181|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8|"The cut-off value for the rSBA-MenC titers was equal to or above 1:8.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
1274182|NCT00322309|Secondary|Percent Urines Positive for Riboflavin|This measure of adherence was determined by finding the percent of total urines examined that were positive for riboflavin, which had been added to each medication tablet.|Weeks 1-11||||Percentage of total urines examined||Standard Deviation|Mean
1274183|NCT00322309|Secondary|Pill Count|Percentage of medication capsules administered based on the ratio of the number of capsules administered to the total number dispensed for entire period during which subjects were in treatment.|Weeks 1 to 11||||Percentage of dispensed capsules||Standard Deviation|Mean
1274184|NCT00322309|Secondary|Hamilton Depression Rating Scale|Subjects are assessed on 24 characteristics of depressive disorders. Scale scores may range from 0 for no depressive symptoms to 75.|Week 11||||Scores on a scale||Standard Deviation|Mean
1274185|NCT00322309|Secondary|The Clinical Global Impression Observer (CGI-O)Comparison for Week 11|Clinician's overall assessment of the subjects global functioning including the severity of the subject's cocaine use, cocaine seeking, use of other drugs, psychiatric symptoms, medical problems, maladaptive family/social coping, and coping with issues related to employment, housing, and legal issues. Totals range between 7 (for none) to 56 for most severe.|Week 11|Data was analyzed fof all subjects for whom data from the second evaluation visit was available|||Scores on a scale||Standard Deviation|Mean
1274186|NCT00322309|Primary|Ln Benzoylecgonine Concentration||Week 11|Data was analyzed for all subjects who provided data for the second assessment visit.|||ln (ng/ml)||Standard Deviation|Mean
1274187|NCT00322231|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination|GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination|From prevaccination (baseline) to 4 weeks postvaccination|Per-protocol population|||Geometric mean fold rise||95% Confidence Interval|Number
1274188|NCT00322231|Secondary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination|4 weeks postvaccination|Per-protocol population|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1274189|NCT00322231|Primary|Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination|SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event|To Day 28 postvaccination|All vaccinated participants were evaluated for safety. This was a crossover study. All participants received one dose each of ZOSTAVAX™ and placebo. Data below reflect SAEs reported after receipt of ZOSTAVAX™ or placebo.|||Participants|||Number
1274190|NCT00322153|Secondary|Change From Baseline in the 19-Item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)|The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).|Baseline to week 24|The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Least Squares Mean
1274191|NCT00322153|Primary|Clinician’s Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)|The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient’s global status relative to Baseline, ranging from a score of 1, indicating “marked improvement” to a score of 4, indicating “no change” to a score of 7, indicating “marked worsening.”|Week 24|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Mean
1274192|NCT00322153|Primary|Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)|The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.|Baseline to week 24|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Least Squares Mean
1274193|NCT00322101|Secondary|Incidence and Severity of Acute and Chronic Graft-vs-host Disease||After transplantation||||participants|||Number
1274194|NCT00322101|Secondary|Incidence of Disease Progression/Relapse|Disease progression/relapse was defined by IWG criteria|After stem cell infusion to date of last follow up.||||participants|||Number
1274195|NCT00322101|Secondary|Donor Cell Engraftment|Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%.|After stem cell infusion to day 28|2 patients who were randomized to receive nonmyeloablative conditioning did not undergo transplant due to relapse and withdrawal of consent|||participants|||Number
1274196|NCT00322101|Secondary|Non-relapse Mortality||At 100 days|2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent|||participants|||Number
1274197|NCT00322101|Secondary|Progression-free Survival|IWG criteria was used to determine disease progression|After stem cell infusion to date of last follow up.|2 patients in the nonmyeloablative arm did not receive a transplant due to relapse and withdrawal of consent|||participants|||Number
1274198|NCT00322101|Primary|Overall Survival||At 2 years|2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent|||participants|||Number
1274199|NCT00322049|Secondary|Percentage of Subjects With a Dengue Viremia 10 Days Post Booster Dose|"Percentage of subjects with a dengue viremia 10 days after each dose of vaccine.~RT PCR = Reverse-transcriptase polymerase chain reaction Nested PCR - Nested polymerase chain reaction~Per protocol, all participants receiving a Dengue Vaccine were combined for Dengue Viremia assessment via RT-PCR and Nested PCR"|10 days after post dose 1 and 2|All participants with evaluable results are reported via RT-PCR and Nested PCR analysis. Scheduled phlebotomy and unscheduled phlebotomy when a subject was ill during the study revealed dengue viremia by RT-/nested PCR, for seven subjects (2 in cohort B and 5 in cohort C).|||% of subjects|||Number
1274200|NCT00322049|Secondary|Incidence of Dengue Specific Symptoms|Percentage of subjects showing incidence of dengue specific symptoms during the 30-day follow-up period after vaccinations|30-day follow-up period after dose 1 and 2||||% of subjects with specified symptoms||95% Confidence Interval|Mean
1274201|NCT00322049|Primary|JE Vaccine Response|Seropositivity rates and GMTs for N lg to JEV antibodies. Pre= Pre vaccination, blood sampling prior to the first vaccine dose; PI(M1)= Post 1, month 1, blood sampling one month after dose 1 at study month 1; PI(M6)= Post 1, month 6, blood sampling 6 months after dose 1 at study month 6; PII(M7)= Post II, month 7, blood sampling one month after dose 2 at study month 7; PIV(M8.5)= Post IV, month 8.5, blood sampling after 2 doses of dengue/control and 2 doses of JE vaccines at study month 8.5|Pre-vaccination, 1, 6, 7 and 8.5 months after two doses of dengue vaccine|Combining of cohorts B and C was due to both cohorts being full dose|||% of subjects with titer within range||95% Confidence Interval|Mean
1274202|NCT00322049|Primary|Percent of Participants With Seronegative Neutralizing (N) Antibody Titers to Each DEN Serotype After Dengue Dose 2 (and 2 Doses of JE|"Seropositivity for N antibody against DEN 1, 2, 3 and 4 antibody after dengue dose 2 (and 2 doses of JE).~Seronegative (antibody titer <10 1/Dil for N lg to DEN-1, N lg to DEN-2, N lg to DEN-3, N lg) prior to vaccination."|month 8.5||||% of responders||95% Confidence Interval|Mean
1274203|NCT00322049|Primary|Percent of Participants With Seronegative Neutralizing (N) Antibody Titers to Each DEN Serotype After Dose 2|"Seronegative for N antibody against DEN 1, 2, 3 and 4 antibody after dengue dose 2.~Seronegative (antibody titer <10 1/Dil for N lg to DEN-1, N lg to DEN-2, N lg to DEN-3, N lg) prior to vaccination."|month 7 after dose 2||||% of responders||95% Confidence Interval|Mean
1274204|NCT00322049|Primary|Geometric Mean Titers (GMT) for N Antibody to All Four Serotypes and Japanese Encephalitis (JE) Vaccine|Assess the immunogenicity of the dengue vaccine in terms of GMTs 30 days post-Dose 2 of dengue vaccine for all four serotypes (DEN-1, 2, 3, 4 and JE (Japanese encephalitis)). Analysis of immunogenicity was performed on the ATP cohort.|30 days post Dose 2|GMT calculated on all subjects. Dil = Dilution; P1(M1) = blood sampling on month after dose 1, at study month 1; PII(M7) = blood sampling one month after dose 2, at study month 7; PII(M8.5) = blood sampling 2 1/2 months after dose 2, at study month 8.5. Combining of cohorts B and C was due to both cohorts being full dose|||titers||95% Confidence Interval|Mean
1274205|NCT00322049|Primary|Reactogenicity in Terms of Solicited Symptoms After Dose 1 of the Dengue Vaccine vs. Control Vaccine.|Local and general solicited reactogenicity using diary cards for 21 days (days 0-20) after the first dose of dengue/control vaccine|21-day follow-up period after Dose 1|Format of results is consistent with how data was presented in the Final Clinical Study Report. Combining of cohorts B and C was due to both cohorts being full dose|||specified events|||Number
1274206|NCT00321984|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Standard Deviation|Mean
1274329|NCT00321763|Primary|Number of Subjects With New Onset of Chronic Diseases (NOCDs).|NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.|From Day 0 to Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1274207|NCT00321984|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Inter-Quartile Range|Median
1274208|NCT00321984|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.|||percentage of days||Standard Deviation|Mean
1274209|NCT00321984|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.|||percentage of days||Inter-Quartile Range|Median
1274210|NCT00321971|Primary|Depressive Symptoms|Depressive symptoms were measured with Center for Epidemiological Studies – Depression Scale (CES-D). The CES-D was designed as a self-report measure of depressive symptoms in nonpsychiatric subjects and has been used with spousal dementia caregiving populations with no report of negative psychological effects. It is composed of 20 items, each rated on a 4-point response scale corresponding to the frequency of the symptom in the preceding week. The possible range of CES-D scores is 0-60, with a higher score indicating more severe symptoms. A cutoff score of 16 or greater is indicative of individuals at high risk for clinical depression. The CES-D was chosen because of its relatively high internal reliability (Cronbach’s alpha = .88) and predictive validity for the diagnosis of depression.|Baseline and 1-, 3-, 6-, and 12- months post-treatment|Using an intention-to-treat approach, we performed a repeated-measures linear mixed effects analysis for each study outcome. This analysis included group assignment (PST-MCI/AD Caregiving vs NT), type of caregiver (MCI versus dementia), and time (baseline, 1-, 3-, 6-, and 12-month follow-up). The depression data were log-transformed for analysis.|||units on a scale||Standard Deviation|Mean
1274211|NCT00321932|Secondary|Mean Change in Total Testosterone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Testosterone affects the brain, bone and muscle mass, fat distribution, the vascular system, energy levels, genital tissues, and sexual functioning.|From Time of Transplant to 12 Months Post-Transplant||||ng/dL||Standard Deviation|Mean
1274212|NCT00321932|Secondary|Mean Change in Ultrasensitive Estradiol|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In women estradiol is responsible for growth of the breast and reproductive epithelia, maturation of long bones and development of the secondary sexual characteristics.|From Time of Transplant to 12 Months Post-Transplant||||pg/ml||Standard Deviation|Mean
1274213|NCT00321932|Secondary|Mean Change in Thyroid Function Test 4|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Individuals who have hyperthyroidism will have an elevated thyroxine (FT4). Low serum thyroxine can also indicate a pituitary problem.|From Time of Transplant to 12 Months Post-Transplant||||ng/dL||Standard Deviation|Mean
1274214|NCT00321932|Secondary|Mean Change in Follicle-Stimulating Hormone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Follicle-stimulating hormone is a hormone produced by the anterior pituitary gland.|From Time of Transplant to 12 Months Post-Transplant||||IU/L||Standard Deviation|Mean
1274215|NCT00321932|Secondary|Mean Change in Luteinizing Hormone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Luteinizing hormone is a hormone produced by the anterior pituitary gland.|From Time of Transplant to 12 Months Post-Transplant||||IU/L||Standard Deviation|Mean
1274216|NCT00321932|Secondary|Mean Change in Urinary N-terminal Telopeptide|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In bone physiology, the N-terminal telopeptide is a biomarker used to measure the rate of bone turnover.|From Time of Transplant to 12 Months Post-Transplant||||nM Bone Collagen Equivalents/mM creatini||Standard Deviation|Mean
1274217|NCT00321932|Secondary|Mean Change in Serum Bone Specific Alkaline Phosphate|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. The decrease in serum bone-specific alkaline phosphatase predicts bone mineral density response to hormone replacement therapy in early postmenopausal women.|From Time of Transplant to 12 Months Post-Transplant||||U/L||Standard Deviation|Mean
1274218|NCT00321932|Secondary|Mean Change in Serum Osteocalcin|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. As osteocalcin is produced by osteoblasts, it is often used as a marker for the bone formation process.|From Time of Transplant to 12 Months Post-Transplant||||ng/ml||Standard Deviation|Mean
1274219|NCT00321932|Primary|Mean Change in Bone Mineral Density|"Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months.~This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline."|From Time of Transplant to 12 Months Post-Transplant||||percent||Standard Deviation|Mean
1275058|NCT00315588|Secondary|Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness|Elimination or reduction in the incidence of hypoglycemic coma or unawareness|1 years||||Participants|||Count of Participants
1274220|NCT00321919|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Values above and below the given reference range were determined as High or Low range values of the laboratory parameter. Roche’s standard reference ranges for laboratory test parameters were used for the analysis. The laboratory parameters with marked abnormality are platelets (reference range is 150-350 10^9 cells/liter [L]), creatinine (reference range is 0-133 micromole per liter), albumin (reference range is 35.0-55 g/L), phosphate (reference range is 0.84-1.45 millimole per liter [mmol /L]) and potassium (reference range is 3.4-4.8 mmol /L).|Baseline, every 3 months up to 4 years|The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment. The ‘’n” represents the number of participants assessed for each laboratory parameter.|||participants|||Number
1274221|NCT00321919|Secondary|Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs|Anti-hypertensive is defined as class of drugs that are used to treat hypertension. Numbers (No.) of participants treated with at least one hypertensive medication/Treatment (Tt) according to class of drugs were reported.|Up to 4 years|The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment.|||participants|||Number
1274222|NCT00321919|Secondary|Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire|The Quality of life was assessed on the basis of a change from baseline in the scores of each of the eight health scales in the SF-36 questionnaire. The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well-being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health (GH), vitality, mental health. The score for a section is an average of the individual question scores, which are scaled from 0 (worst level of functioning) to 100 (100=best level of functioning). The least squares mean (LSM) change from baseline was determined by Analysis of covariance (ANCOVA) model and presented for each of the eight health scale.|Baseline, Year 1, and Year 2|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||units on a scale||Standard Error|Least Squares Mean
1274223|NCT00321919|Secondary|Mean Values of Body Surface Area|The body surface area (BSA) was determined by Echocardiogram. Absolute mean values of Echocardiography (ECHO) Parameter: Body surface area (BSA) at Baseline, Year 1, Year 2, Year 3 and Year 4 were calculated and presented.|Baseline, Year 1, Year 2, Year 3, and Year 4.|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for Body surface area through echocardiogram at Baseline, Year 1, Year 2, Year 3 and Year 4.|||Square meter||Standard Deviation|Mean
1274224|NCT00321919|Secondary|Mean Values of Echocardiography Parameters|Mean values of Echocardiography (ECHO) Parameters: Left Ventricular End Diastolic Diameter (LVEDD), Left Ventricular Posterior Wall Thickness (LVPWT), IV Septal Wall Thickness (IVSWT), LV End Systolic Diameter (LVESD), LV Relative wall thickness (LVRWT) at Baseline, Year 1, Year 2, Year 3 and Year 4 were presented.|Baseline, Year 1, Year 2, Year 3, and Year 4|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for each echocardiography parameter at Baseline, Year 1, Year 2, Year 3 and Year 4.|||centimeters||Standard Deviation|Mean
1274225|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Volume (LV Volume )|Left Ventricular Volume is the estimated of left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) determined by Echocardiogram. The change was calculated as week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LV Volume at Baseline, Week 12, Week 24, Week 36 and Week 48.|||milliliters per meter square||Standard Deviation|Mean
1274226|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)|LVEF is a marker of left ventricular systolic function and determined by echocardiogram. It is expressed as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage. FS is used as an estimate of myocardial contractility and determined by echocardiogram and measures as a percentage. The change for LVEF and FS was calculated as Week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LVEF and FS at Baseline, Week 12, Week 24, Week 36, and Week 48.|||percentage||Standard Deviation|Mean
1274227|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Mass Index (LVMI)|LVMI is determined by echocardiogram. LVMI indexed to body surface area (gram/square meter) estimated by LV cavity dimension and wall thickness at end-diastole. The change was calculated as week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LVMI at Baseline, Week 12, Week 24, Week 36, and Week 48.|||gram/square meter||Standard Deviation|Mean
1274228|NCT00321919|Secondary|Duration of Hospitalization for Cardiovascular Events|The duration of hospitalization was the total number of days that a participant was hospitalized due to cardiovascular events. Participants with no hospitalization were excluded from analysis.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. Data for the participants present at the time of assessment was used for analysis.|||days||Standard Deviation|Mean
1274229|NCT00321919|Secondary|Median Time to First Hospitalization Due to Cardiovascular Events|Time to first hospitalization due to cardiovascular events is defined as the time determined between randomization and first hospitalization due to cardiovascular events.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
1274230|NCT00321919|Secondary|Total Number of Cardiovascular Intervention|Cardiovascular intervention was defined by a clinical review of all concomitant treatments. The cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. The total number of cardiovascular intervention was determined and presented by each cohort.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||number of cardiovascular intervention|||Number
1274231|NCT00321919|Secondary|Median Time to First Cardiovascular Intervention|Time to first cardiovascular intervention is the time between randomization and first intervention determined for all cardiovascular interventions after randomization. Cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
1274232|NCT00321919|Secondary|Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)|The NYHA functional classification assesses the severity of symptoms of chronic heart failure and is comprised of four classes. Class I is defined as no limitation of physical activity, Class II is defined as slight limitation of physical activity, Class III is defined as marked limitation of physical activity, and Class IV is defined as unable to carry on any physical activity without discomfort. Shifts of participants from CL 0, CL I, CL II, CL III, CL IV at Baseline (Day 1) to CL 0, CL I, CL II, CL III, CL IV during the study period was determined and presented.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for shifts in NYHA class from baseline.|||participants|||Number
1274233|NCT00321919|Secondary|Number of Participants Who Died Due to All Causes|Number of participants who died due to all causes are presented in table below.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||participants|||Number
1274234|NCT00321919|Secondary|Median Time to Death Due to All Causes|Time to death due to all causes is the time determined between randomization and death due to all causes.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
1274235|NCT00321919|Secondary|Number of Participants Who Died Due to Cardiovascular Events|The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||participants|||Number
1274236|NCT00321919|Secondary|Median Time to Death Due to Cardiovascular Events|Time to death due to cardiovascular events is the time determined between randomization and death due to cardiovascular events.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
1274237|NCT00321919|Primary|Median Time to First Cardiovascular Event|The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
1274238|NCT00321906|Secondary|Overall Survival at 36 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 36 months.|36 mos||||percentage of participants|||Number
1274239|NCT00321906|Secondary|Overall Survival at 24 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 24 months.|24 mos||||percentage of participants|||Number
1274240|NCT00321906|Secondary|Overall Survival at 12 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 12 months.|12 mos||||percentage of participants|||Number
1274241|NCT00321906|Secondary|Bronchiolitis Obliterans Syndrome (BOS) at 36 Months|Kaplan-Meier estimate of proportion of patients that had not experienced BOS by 36 months.|36 mos||||percentage of participants|||Number
1274242|NCT00321906|Secondary|Bronchiolitis Obliterans Syndrome (BOS) at 24 Months|Kaplan-Meier estimate of proportion of patients that had not experienced BOS by 24 months.|24 mos||||percentage of participants|||Number
1274243|NCT00321906|Secondary|Severity of Acute Rejection at 12 Months|"Raw proportion of patients that experienced rejection at or above grade A2 by 12 months.~Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate"|12 mos||||percentage of participants|||Number
1274244|NCT00321906|Secondary|Acute Rejection-free Survival at 12 Months|"Kaplan-Meier estimate of proportion of patients that had not experienced acute rejection by 12 months. Acute rejection is defined as rejection at any of the following grades.~Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate"|12 mos|The analysis population included patients who underwent at least one transbronchial biopsy.|||percentage of participants|||Number
1274245|NCT00321906|Primary|Acute Rejection Rate at 12 Months|Raw proportion of patients that experienced acute rejection at or before 12 months.|12mos||||percentage of participants|||Number
1274246|NCT00321893|Primary|Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months|Number of participants with response according to RECIST criteria. For single nodules > 5 mm, clinical meaningful shrinkage of 30% or > of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD <5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.|12 Months|Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the follow up Computed Tomography (CT) scan.|||participants|||Number
1274247|NCT00321893|Primary|Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months|For single nodules >5 mm, clinical meaningful shrinkage of 30% or > longest diameter (LD) considered treatment success after 1 year treatment; for <5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target & non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% > sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.|12 Months|Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the Computed Tomography (CT) scan.|||participants|||Number
1274248|NCT00321893|Primary|Size of CT- Detected Lung Nodules by Participant|Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years|Baseline assessment|Per person analysis. Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.|||lung nodules|Participants||Number
1274249|NCT00321893|Primary|Number CT- Detected Lung Nodules by Participant|Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.|Baseline assessment|Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.|||lung nodules|Participants||Number
1274250|NCT00321854|Secondary|Clinically Significant Abnormalities in Vital Signs||Baseline and Month 15|Phase 1 Treated set for sinus bradycardia with N of 261 for Early PPX and 274 for Delayed PPX. Phase 2 Treated set for hypotension with N of 221 for Early PPX and 214 for Delayed PPX.|||percentage of participants|||Number
1274251|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates||Baseline and Month 15|Glucose-N was 28 for Early PPX and 46 for Delayed PPX, Cholesterol and Triglyceride-N was 213 for Early PPX and 208 for Delayed PPX, Blood Urea Nitrogen-N was 214 for Early PPX and 209 for Delayed PPX, Creatinine-N was 200 for Early PPX and 202 for Delayed PPX, Uric Acid-N was 212 for Early PPX and 209 for Delayed PPX.|||percentage of participants|||Number
1274252|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes||Baseline and Month 15|Gamma Glutamyltranspeptidase (GGT-N) was 214 for Early PPX and 208 for Delayed PPX, Amylase-N was 214 for Early PPX and 209 for Delayed PPX|||percentage of participants|||Number
1274253|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes||Baseline and Month 15|Treated set: Haematocrit and mean corpuscular volume (MCV-N) was 211 for Early PPX and 209 for Delayed PPX, Haemoglobin-N was 213 for Early PPX and 212 for Delayed PPX, Sodium-N was 211 for Early PPX and 209 for Delayed PPX, Calcium and Chloride-N was 214 for Early PPX and 209 for Delayed PPX, Phosphate-N was 201 for Early and Delayed PPX|||percentage of participants|||Number
1274254|NCT00321854|Secondary|Percentage Change From Baseline in the Striatum Uptake at Month 15|The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).|Baseline and Month 15|The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake.|||Percentage change||Standard Error|Least Squares Mean
1274255|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274585|NCT00319748|Secondary|Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)|Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Only 9 patients had recorded values at 6 hours after treatment and were included in analysis.|||pg/mL||95% Confidence Interval|Mean
1274256|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274257|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274258|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274259|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274260|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274261|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274262|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274263|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274264|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274265|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274266|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274267|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1275059|NCT00315588|Secondary|Reduction of Insulin Requirements|Reduction in insulin requirements in those patients who do not achieve insulin independence|1year||||Participants|||Count of Participants
1274268|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274269|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
1274270|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9|The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 5 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
1274271|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15|The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
1274272|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9|The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
1274273|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15|The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
1274274|NCT00321854|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
1274275|NCT00321854|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial.|||Units on a scale||Inter-Quartile Range|Median
1274276|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274277|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274278|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274279|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient BDI data.|||Units on a scale||Standard Error|Least Squares Mean
1274280|NCT00321854|Secondary|Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15|The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 4 patients from the FAS2 were excluded due to insufficient CGI-I data.|||Participants|||Number
1274281|NCT00321854|Secondary|Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15|The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 27 patients from the FAS2 were excluded due to insufficient CGI-I data.|||Participants|||Number
1274282|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274283|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274284|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274285|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274286|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
1274287|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274288|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274289|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274290|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274291|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
1274292|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274293|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1276342|NCT00303823|Primary|Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia||4 months||||participants|||Number
1274294|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274295|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274296|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
1274297|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274298|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274299|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274300|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274301|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
1274302|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274303|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274304|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274305|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
1274369|NCT00321464|Secondary|Time to First and Subsequent On-Study Skeletal-Related Event|Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative number of events.|Up to 34 months|Full Analysis Set, composed of all randomized participants|||Events|||Number
1274306|NCT00321854|Primary|Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 15|The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
1274307|NCT00321828|Secondary|Overall Survival as Measured by Death From Any Cause||Time from start of study through year 5|||||||
1274308|NCT00321828|Secondary|Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0||Time from start of study through year 5|||||||
1274309|NCT00321828|Secondary|Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery||Time from start of study through year 5|||||||
1274310|NCT00321828|Secondary|Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery||Time from start of study through year 5|||||||
1274311|NCT00321828|Secondary|Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery||Time from start of study through year 5|||||||
1274312|NCT00321828|Secondary|Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration||Time from start of study through year 5|||||||
1274313|NCT00321828|Primary|Major Morbidity Related to the Intact Primary Tumor|Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.|24 months||||probability of major morbidity (%)||95% Confidence Interval|Number
1274314|NCT00321789|Secondary|Number of Participants Prescribed Cholesterol Medication|This was assessed via electronic medical record abstraction. Results could not be modeled statistically due to missing data/small cell sizes (i.e., not all participants had a prescription for medication because this was not an inclusion criterion).|11-month follow-up||||participants|||Number
1274315|NCT00321789|Secondary|Number of Participants With Goal LDL-C|Assessed via non-fasting blood test. Goal is determined by 2003 National Cholesterol Education Program guidelines. Goal could be 160mg/dL for low risk (no coronary heart disease (CHD), 0-1 risk factor); 130 mg/dL for medium risk (no CHD, at least 2 risk factors); or 100 mg/dL for high risk (CHD and risk equivalents including diabetes, atherosclerotic disease, and multiple risk factors that confer a 10-year risk for CHD >20% per Framingham score).|11-month follow-up||||participants|||Number
1274316|NCT00321789|Secondary|Saturated Fat (%)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||percentage of calories||Standard Deviation|Mean
1274317|NCT00321789|Secondary|Total Fat (%)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||percentage of calories||Standard Deviation|Mean
1274318|NCT00321789|Secondary|Duration of Moderate Intensity Physical Activity|Self-reported via Community Health Activities Model Program for Seniors questionnaire.|11-month follow-up||||hours per week||Inter-Quartile Range|Median
1274319|NCT00321789|Secondary|Frequency of Moderate Intensity Physical Activity|Self-reported via Community Health Activities Model Program for Seniors questionnaire.|11-month follow-up||||times per week||Inter-Quartile Range|Median
1274320|NCT00321789|Secondary|Fiber Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire.|11-month follow-up||||grams per day||Standard Deviation|Mean
1274321|NCT00321789|Secondary|Cholesterol Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||milligrams per day||Standard Deviation|Mean
1274322|NCT00321789|Secondary|Total Fat (Grams/Day)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||grams per day||Standard Deviation|Mean
1274323|NCT00321789|Secondary|Saturated Fat (Grams/Day)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||grams per day||Standard Deviation|Mean
1274324|NCT00321789|Secondary|Caloric Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||kcal/day||Standard Deviation|Mean
1274325|NCT00321789|Primary|Low-density Lipoprotein Cholesterol|assessed with non-fasting blood test|11-month follow-up||||mg/dL||Standard Deviation|Mean
1274326|NCT00321763|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.|During the entire study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1274327|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1274370|NCT00321464|Secondary|Time to First On-Study Skeletal-Related Event (Superiority)|Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.|Up to 34 months|Full Analysis Set, composed of all randomized participants.|||Participants|||Number
1274330|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .|||subjects|||Number
1274331|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .|||subjects|||Number
1274332|NCT00321763|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1274333|NCT00321763|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1274334|NCT00321763|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1274335|NCT00321763|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1274336|NCT00321737|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
1274337|NCT00321737|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
1274338|NCT00321737|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.|||Percentage of Subjects|||Number
1274339|NCT00321737|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
1274340|NCT00321737|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
1275060|NCT00315588|Secondary|Stimulated C-peptide Greater Than 0.5 ng/ml|Partial graft function, as evidenced by basal C-peptide greater than 0.5 ng/ml|1 year||||Participants|||Count of Participants
1274341|NCT00321737|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.|||Percentage of Subjects|||Number
1274342|NCT00321711|Secondary|Platelet Transfusion|Occurrence of one or more platelet transfusions from study day 1 through the interim follow-up visit (16 weeks)|Study day 1 through the interim follow-up visit (up to 20 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
1274343|NCT00321711|Secondary|Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period|CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
1274344|NCT00321711|Secondary|Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia|Occurrence of hypomethylating agent dose reduction and delay due to thrombocytopenia|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
1274345|NCT00321711|Primary|Occurrence of a Clinically Significant Thrombocytopenic Event|Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
1274346|NCT00321698|Secondary|Clinical Progression-free Rate as Determined by <0.1ng PSA Results|The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.|3, 6, 9, 12 months and annually, up to 5 years||||percentage of participants||95% Confidence Interval|Number
1274347|NCT00321698|Secondary|Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures|"Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score.~AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe.~EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL."|Baseline and 12 Months Post-Prostatectomy|Scores not available for some participants|||units on a scale||95% Confidence Interval|Mean
1274348|NCT00321698|Secondary|Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)|"Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:~The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body."|5 weeks|For Phase I Dose 1-4, all participants were combined for this assessment as pre-specified in the protocol.|||Participants|||Count of Participants
1274349|NCT00321698|Secondary|Clinical Response to Treatment as Measured by Urologic Examination||Regular intervals (clinical contact)||2020-12-31|12/2020||||
1274350|NCT00321698|Secondary|Long-term Safety||Regular intervals (clinical contact)||2020-12-31|12/2020||||
1274351|NCT00321698|Secondary|Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA|"All participants were combined for this assessment as pre-specified in the protocol.~The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported.~PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years"|Baseline (pre-treatment) and 1 month after surgery (post-treatment)|Pre- and post-treatment PSA values were available in 22 of 25 patients.|||percentage change||95% Confidence Interval|Mean
1274352|NCT00321698|Primary|Pathologic Response Rate at the Phase II Dose|"Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:~The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b."|4-6 weeks after study treatment||||participants|||Number
1274353|NCT00321698|Primary|Maximum Tolerated Dose (MTD)|"Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel.~The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling).~MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped."|5 weeks||||mg/m^2|||Number
1275061|NCT00315588|Primary|Insulin Independence.|Number of Participants who Achieved Insulin Independence at 1 Year|1 year||||Participants|||Count of Participants
1274354|NCT00321685|Secondary|5-year Recurrence-free Survival Rate|Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients. 5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula.|recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration|Eligible and treated patients who underwent surgery after neoadjuvant therapy|||percentage of participants||90% Confidence Interval|Number
1274355|NCT00321685|Secondary|5-year Overall Survival Rate|Overall survival is defined as time from registration to death from any cause. 5-year overall survival rate is estimated using Kaplan-Meier method.|survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1274356|NCT00321685|Secondary|Resection Rate for T4 Rectal Cancers|Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers|Assessed at surgery time|eligible and treated patients with T4 rectal cancers|||percentage of participants||90% Confidence Interval|Number
1274357|NCT00321685|Secondary|Resection Rate for T3 Rectal Cancers|Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers|Assessed at surgery time|eligible and treated patients with T3 rectal cancers|||percentage of participants||90% Confidence Interval|Number
1274358|NCT00321685|Primary|Pathologic Complete Response Rate|Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients|Assessed at surgery time|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1274359|NCT00321672|Secondary|Proportion of Subjects Reaching 30% Decrease in Their Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12||Weeks 2-12||||Percentage of Participants|||Number
1274360|NCT00321672|Secondary|Absolute Change in the Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.||Weeks 2-12.||||Numeric Pain Rating Scale (0 to 10)||Standard Error|Least Squares Mean
1274361|NCT00321672|Primary|The Primary Measure of Efficacy Was the Percent Change in the “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.|"Efficacy was assessed by daily Numeric Pain Rating Scale (NPRS) capturing average pain for the past 24 hours for painful HIV-associated neuropathy area(s) at approximately 9 PM every evening throughout the 12-week study period. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain."|Weeks 2-12|Analyses were intention to treat (ITT). A modified last observation carried forward (LOCF) approach was used to impute missing data. Each NGX-4010 group was compared with its respective control group.|||Percent Change from baseline||Standard Error|Least Squares Mean
1274362|NCT00321646|Secondary|PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.|The rate of PSA decline by 50% compared to baseline PSA.|after 6 months of ajuvant chemotherapy.||||proportion of participants||95% Confidence Interval|Number
1274363|NCT00321646|Primary|Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy|A response was defined as a decrease in tumor size of >50% for the largest lesion in the prostate by endorectal MRI.|after 6 months of neoadjuvant chemotherapy.||||proportion of participants||95% Confidence Interval|Number
1274364|NCT00321620|Secondary|Time to the First-And-Subsequent On-Study SRE|"Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.~This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events."|Up to 40.5 months|Full Analysis Set, composed of all randomized participants|||Events|||Number
1274365|NCT00321620|Secondary|Time to the First On-Study SRE (Superiority)|Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.|Up to 40.5 months|Full Analysis Set, composed of all randomized participants|||Days||95% Confidence Interval|Median
1274366|NCT00321620|Primary|Time to the First On-Study SRE (Non-inferiority)|Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.|Up to 40.5 months|Full Analysis Set, composed of all randomized participants|||Days||95% Confidence Interval|Median
1274367|NCT00321594|Primary|Tumor Response in Patients With Inoperable HCC Using Belinostat (Phase II)|Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The 95% confidence intervals should be provided.|Every 2 courses (approximately 6 weeks)||||Participants|||Count of Participants
1274368|NCT00321594|Primary|Dose-limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) of Belinostat in Patients With Inoperable HCC (Phase I)|DLT is defined as any grade 4 hematological toxicity and any grade 3 or 4 non hematological toxicity during cycle 1, excluding alopecia. Specifically, grade 3 nausea, vomiting, or diarrhea that does not respond to therapy is considered dose-limiting. Also, delays in treatment greater than 2 weeks are also dose-limiting. MTD is defined as the dose below which >= 2 of 3 or >= 2 of 6 patients experience DLT. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Course 1||||Participants|||Count of Participants
1274371|NCT00321464|Primary|Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)|Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.|Up to 34 months|Full Analysis Set, composed of all randomized participants.|||Participants|||Number
1274372|NCT00321373|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination.|During the entire study period (Day 0 to Day 180)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
1274373|NCT00321373|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1274374|NCT00321373|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) follow up period after vaccination|The analysis was based on the Total vaccinated Cohort which included all vaccinated subjects with the symptom sheet completed.|||Subjects|||Number
1274375|NCT00321373|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort that included all vaccinated subjects with the symptom sheet completed.|||Subjects|||Number
1274376|NCT00321373|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus|Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.|At Day 180 post-vaccination.|The analysis was based on the ATP cohort for immunogenicity at Day 180 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.|||titer||95% Confidence Interval|Geometric Mean
1274377|NCT00321373|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus|Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0 and 21 post-vaccination|The analysis was based on the ATP cohort for immunogenicity at Day 21 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.|||titer||95% Confidence Interval|Geometric Mean
1274378|NCT00321321|Primary|Insulin Secretion|area under the curve AUC and insulin secretion rate|0 - 90 minutes||||pmol/l * 90 minutes|||Number
1274379|NCT00321269|Secondary|Health-Related Quality of Life|Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.|Measured at week 1, week 8|Older Veterans with Congestive Heart Failure|||units on a scale||Standard Deviation|Mean
1274380|NCT00321269|Primary|Beck Depression Inventory II|Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.|Depression and psychological health will be assessed at week 1, week 8|Older Veterans with Heart Failure|||units on a scale||Standard Deviation|Mean
1274381|NCT00320801|Primary|The Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).|Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)|The safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 safety assessment after the initial dose of BTDS in the study.|||Participants|||Number
1274382|NCT00320788|Post-Hoc|Mean Change in BCVA as Measured by ETDRS From Baseline at Week 16|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|Baseline and at Week 16|FAS used for analysis, LOCF|||letters read||Standard Deviation|Mean
1274383|NCT00320788|Post-Hoc|Mean Change of CR/LT From Baseline at Week 16|CR/LT measured in micrometers (µm); lower individual values represent better outcomes|Baseline and at Week 16|FAS used for analysis, LOCF|||µm||Standard Deviation|Mean
1274384|NCT00320788|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|At Week 12|FAS used for analysis, LOCF|||percentage of participants|||Number
1274385|NCT00320788|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|Baseline and at week 12|FAS used for analysis, LOCF|||letters read||Standard Deviation|Mean
1274386|NCT00320788|Secondary|Mean Percent Change of CR/LT From Baseline at Week 12|CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome|Baseline and at Week 12|FAS used for analysis, LOCF|||percent change||Standard Deviation|Mean
1274387|NCT00320788|Primary|Mean Change of CR/LT From Baseline at Week 12|CR/LT measured in micrometers (µm); lower individual values represent better outcomes.|Baseline and at Week 12|Full Analysis Set (FAS) used for analysis, Last Observation Carried Forward (LOCF)|||μm||Standard Deviation|Mean
1274388|NCT00320749|Secondary|Therapeutic Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks, up to 24 weeks|3 patients were non-evaluable for response or progression free survival as they withdrew consent after cycle 1 of therapy.|||percent of patients|||Number
1274389|NCT00320749|Secondary|Common Toxicities|The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.|Weekly up to 24 weeks|grade 3 and grade 4 toxicities according to National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0|||percent of patients|||Number
1274390|NCT00320749|Primary|Maximum Tolerated Dose (MTD)|MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).|Weekly up to 24 weeks||||mg/m^2|||Number
1274391|NCT00320710|Secondary|Skeletal Morbidity Rate|An SMR for a patient was defined as the “number of occurrences” of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the “time at risk” in years. The “number of occurrences” and the “time at risk” were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as “at risk”. For example, if a patient had 1 SRE during the study, the “time at risk” was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as “time at risk”. This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE).|52 weeks|This population included all participants who were in the zoledronic acid q 4 weeks and zoledronic acid q 12 weeks treatment groups.|||Number of events per year||Standard Deviation|Mean
1274392|NCT00320710|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase|Serum samples were collected to obtain bone specific alkaline phosphatase values.|baseline, 48 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 48 values.|||mcg/L||Standard Deviation|Mean
1274393|NCT00320710|Secondary|Change From Baseline in Urinary N-telopeptide / Creatinine Ratio|Urine samples were collected to obtain n-telopeptide and creatinine values.|baseline, 48 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 48 values.|||ratio||Standard Deviation|Mean
1274394|NCT00320710|Secondary|Change From Baseline in Mean Analgesic Score|The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates worsening.|baseline, 52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 52 values.|||score||Standard Deviation|Mean
1274395|NCT00320710|Secondary|Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score|Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.|baseline, 52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 52 values.|||scores on a scale||Standard Deviation|Mean
1274396|NCT00320710|Secondary|Time to First Individual Type of SRE|Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.|||Weeks||95% Confidence Interval|Median
1274397|NCT00320710|Secondary|Time to First SRE|An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.|||Days||95% Confidence Interval|Median
1274398|NCT00320710|Primary|Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)|An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.|||Percentage of participants|||Number
1274409|NCT00320606|Secondary|Number of Participants Who Suffered Graft Loss or Died Following Initiation of Immunosuppression Withdrawal|Participants who died while on the study for any reason as well as participants that experienced the loss of their transplant while a participant in the study.|Enrollment through end of study (up to 9.5 years)|Intent-to-Treat|||Participants|||Count of Participants
1274410|NCT00320606|Primary|Proportion of Participants Successfully Withdrawn From Immunosuppression|Participants were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function.|1 year after completion of immunosuppression withdrawal|Intent-to-Treat|||Proportion of participants|||Number
1275528|NCT00310401|Primary|Donor Oxygenation|The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement|Change from enrollment to organ procurement (about ~40h after enrollment)||||cmH2O||Inter-Quartile Range|Median
1274399|NCT00320671|Primary|Percentage of Participants That Responded to Treatment|Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28|this outcome was assessed throughout the study.|BPRS-A and CGI scores for each group were analysed to determine the percentage of participants that responded to apriprazole and risperidone. The threshold for significance was p=.05|||percentage of response||95% Confidence Interval|Number
1274400|NCT00320606|Secondary|Percent Change From Baseline in Diastolic Blood Pressure|Diastolic blood pressure (BP) measures the pressure in the arteries when the heart is a rest and is thus filled with blood. This outcome assesses the percent change from baseline (diastolic blood pressure measurement at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-to-treat with diastolic blood pressure data available at visit|||Percent change||Inter-Quartile Range|Median
1274401|NCT00320606|Secondary|Percent Change From Baseline in Systolic Blood Pressure|Systolic blood pressure (BP) measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. This outcome assesses the percent change from baseline (systolic blood pressure measurement at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-to-treat with systolic blood pressure data available at visit|||Percent change||Inter-Quartile Range|Median
1274402|NCT00320606|Secondary|Percent Change From Baseline in Blood Glucose|Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. The outcome looks at the percent change from baseline (glucose level at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-To-Treat with glucose data available at visit|||Percent change||Inter-Quartile Range|Median
1274403|NCT00320606|Secondary|Percent Change From Baseline in Total Cholesterol|Percent change from baseline in total serum cholesterol. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. This outcome looks at the percent change from baseline (cholesterol level at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-To-Treat with cholesterol data available at visit|||Percent change||Inter-Quartile Range|Median
1274404|NCT00320606|Secondary|Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR)|Percent change from baseline at each annual visit. The bedside Schwartz equation was used to estimate GFR from serum creatinine and height in children. Baseline serum creatinine was utilized in the equation, defined as the creatinine value at the start of IS tapering. Baseline height was utilized in the equation, defined as the last height recorded prior to the start of IS tapering. Serum creatinine measurements and height measurements at the annual visits were used to calculate the annual GFR. When height value was not available, the height collected prior to the annual visit was used in the GFR calculation. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-To-Treat with GFR data at visits available for analysis|||Percent change||Inter-Quartile Range|Median
1274405|NCT00320606|Secondary|Number of Participants Experiencing Adverse Events by Severity|The results provide the total number of participants experiencing adverse events (AEs). Participants experiencing AEs are stratified into five severity categories: mild, moderate, severe, life-threatening, and death, based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.|Enrollment through end of study (up to 9.5 years)|Intent-To-Treat|||Participants|||Count of Participants
1274406|NCT00320606|Secondary|Distribution of Histologic Severity Among Rejection Episodes|The number of participants within each level of histologic severity based on BANFF grading criteria (Mild, Moderate, Severe).|Start of immunosuppressive withdrawal to rejection through end of study (up to 9.5 years)|Participants from the Intent-to-treat group who experienced a biopsy-proven rejection episode|||Biopsy Proven rejection episodes|||Number
1274407|NCT00320606|Secondary|Immunosuppression-Free Duration|The number of months between the end of immunosuppression withdrawal and either the end of trial participation or the time of restarting immunosuppression|Completion of Withdrawal to either end of trial participation (up to 9.5 years) or time to restarting immunosuppression|Intent-to-Treat participants who completed withdrawal|||Months||95% Confidence Interval|Mean
1274408|NCT00320606|Secondary|Time From Start of Immunosuppression Withdrawal to the First Episode of Acute Rejection, Second Episode of Rejection That Did Not Require Treatment, or to Diagnosis of Chronic Rejection|The number of days between the start of immunosuppression (IS) withdrawal and the first episode of acute rejection (either clinical rejection or based on BANFF criteria), second episode of rejection that did not require treatment, or the first diagnosis of chronic rejection.|From the start of immunosuppression withdrawal to first acute rejection, second episode of rejection that did not require treatment, or diagnosis of chronic rejection through end of study (up to 9.5 years)|Intent-to-Treat participants who experienced acute rejection or were diagnosed with chronic rejection.|||Days||95% Confidence Interval|Mean
1276343|NCT00303823|Primary|Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease||4 months||||participants|||Number
1274411|NCT00320593|Secondary|Excellent Spectacle Compliance|Spectacle compliance was assessed on a five-point Likert scale: always, 5; often, 4; sometimes, 3; rarely, 2; and never, 1. Excellent compliance indicates that for the specified period (during school, after school, on weekends), spectacles were estimated at all visits to have been worn either always or often.|Baseline to 3 years|The analysis followed the intent-to-treat principle. Two patients had no compliance data because they had no follow-up visits (one single vision lenses, and one progressive-addition lenses).|||percent of participants|||Number
1274412|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 2 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 2 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 2 years|The analysis followed the intent-to-treat principle|||diopters||Standard Deviation|Mean
1274413|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 1 year, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 1 year. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 1 year|The analysis followed the intent-to-treat principle.|||diopters||Standard Deviation|Mean
1274414|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.|||diopters||Standard Deviation|Mean
1274415|NCT00320593|Secondary|Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.|||participants|||Number
1274416|NCT00320593|Primary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|3 years|All analyses followed the intent-to-treat principle. The Monte Carlo Markov Chain (MCMC) method of multiple imputation was used to impute data for subjects who did not complete the 3-year visit.|||diopters||Standard Deviation|Mean
1274417|NCT00320593|Secondary|Mean Spherical Equivalent Refractive Error at 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.|3 years|The analysis followed the intent-to-treat principle.|||diopters||Standard Deviation|Mean
1274418|NCT00320593|Primary|Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.|||participants|||Number
1274419|NCT00320593|Secondary|Distribution of Spherical Equivalent Refractive Error at 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.|3 years|The analysis followed the intent-to-treat principle.|||participants|||Number
1274420|NCT00320541|Secondary|Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy|The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
1275122|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 8)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|8 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
1274421|NCT00320541|Secondary|Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy|The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
1274422|NCT00320541|Secondary|Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy|The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
1274423|NCT00320541|Secondary|Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy|The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
1274424|NCT00320541|Secondary|Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy|The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
1274425|NCT00320541|Secondary|Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy|The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
1274426|NCT00320541|Secondary|Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), & additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
1274427|NCT00320541|Secondary|Overall Survival|Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date.|baseline to death from any cause (up to 35 months)|Intent-To-Treat (ITT) population=all randomized participants, eligible & ineligible. Number of participants with events: PB=35; PB+G=34. Censored participants: PB=59;PB+G=59.|||months||Full Range|Median
1274428|NCT00320541|Secondary|Progression-free Survival (PFS)|PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date.|baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)|ITT population=all randomized participants, eligible & ineligible. Participants with events: PB=74; PB+G=72. Censored participants: PB=20 PB+G=21.|||months||Full Range|Median
1274429|NCT00320541|Primary|Overall Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).|baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)|Per-protocol population included intent-to-treat participants who met the following criteria: histological or cytological breast cancer diagnosis; baseline presence of measurable disease per RECIST; at least 1 dose of study drug; no current systemic anti-tumor therapy except protocol-specified therapy. One PB+G participant did not qualify.|||proportion of responders||95% Confidence Interval|Mean
1274430|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
1274431|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)|The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).|Baseline, 12 Weeks|Number of child patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1274432|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)|Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).|Baseline, 12 Weeks|Number of adolescent patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1274433|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale|Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
1274434|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
1274435|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)|The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
1274436|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||T-Score||95% Confidence Interval|Mean
1274437|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
1274438|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)|Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
1274439|NCT00320528|Primary|Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||T-Score||95% Confidence Interval|Mean
1274440|NCT00320515|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug and had measurable disease at baseline. Thirty-five participants were censored.|||months||95% Confidence Interval|Median
1274441|NCT00320515|Secondary|Progression Free Survival|The period from study entry until disease progression or death on study, whichever occurred first.|baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug and had measureable disease at baseline. Twenty-six participants were censored.|||months||95% Confidence Interval|Median
1274442|NCT00320515|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug, had measureable disease at baseline, and had confirmed complete or partial responses. There were 16 patients qualified for the analysis of duration of response. Twelve participants were censored.|||months||95% Confidence Interval|Median
1274443|NCT00320515|Primary|Objective Best Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug. One participant was excluded from analysis because of no measurable disease at baseline.|||participants|||Number
1274444|NCT00320489|Secondary|Participants Discontinuing Because of an Adverse Event (AE) or Death||Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
1274445|NCT00320489|Secondary|Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin|Treatment-emergent (TE) high ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to >=3 times the ULN at endpoint. TE high AST is defined as a baseline value of <5 times the ULN to >=5 times the ULN at endpoint. TE high total bilirubin is defined as a baseline value of <2 times the ULN to >=2 times the ULN at endpoint. Hy's Rule is defined as ALT >=3 times the ULN and total bilirubin >=2 times the ULN.|Baseline through 104 Weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
1274446|NCT00320489|Secondary|Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks|The prolactin reference Range is: Female: 2.0 - 29.0 nanograms per milliliter (ng/mL); Male: 2.0 - 20.0 ng/mL. A treatment-emergent abnormally high value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.|Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
1274447|NCT00320489|Secondary|Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides|Normal to high fasting glucose = <100 milligrams per deciliter (mg/dL) baseline; >=126 mg/dL any time post baseline (or endpoint). Normal to high fasting total cholesterol =<200 mg/dL baseline; >=240 mg/dL any time post baseline or endpoint. Fasting triglycerides <150 mg/dL baseline; >=200 mg/dL and <500 mg/dL any time post baseline or endpoint.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
1274448|NCT00320489|Secondary|Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks|PCS weight gain is defined as a >=7% increase in weight from baseline at 104 weeks.|Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
1274449|NCT00320489|Secondary|Change From Baseline in Weight at 104 Weeks||Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Kilograms||Standard Deviation|Mean
1274450|NCT00320489|Secondary|Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization|Number of outpatient surgeries during the study, post-baseline through 104 weeks.|Baseline through 104 Weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Surgeries||Standard Deviation|Mean
1274451|NCT00320489|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks|BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. For this study, the BPRS total score was derived from 18 PANSS questions. To calculate the score, the score of the 18 questions was added then 18 was subtracted from the total. As an example, if a subject had a score=1 (absent) on all 18 items, the resulting total=zero. Responses range from 0 (absent) to 6 (extremely severe); the Total Score range is 0-108.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a scale||Standard Error|Least Squares Mean
1275937|NCT00307489|Primary|Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48||48 weeks|Randomized and Treated (RAT) subjects at Week 48 - Non-Completers=Failure (ie, includes subjects who switched to open-label FTC/TDF at or after Week 24)|||percentage of participants|||Number
1274452|NCT00320489|Secondary|Number of Participants Experiencing Relapse|Relapse is defined as any one of the following: 1) hospitalization for symptoms related to schizophrenia; 2) an increase of 25% from baseline in the total score on the PANSS (if the baseline score was >40), or an increase of 10 points (if baseline score was <=40) and >=1-point increase from baseline score on the CGI-S score, provided that the increase results in a CGI-S score >=4; 3) deliberate self-injury or injury to others that is deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
1274453|NCT00320489|Secondary|Median Time to Relapse|Relapse is defined as any 1 of the following: 1) hospitalization for symptoms related to schizophrenia; 2) increase of 25% from baseline in PANSS total score (range:30-210) (if baseline score was >40) or increase of 10 points (if baseline score was ≤40), and ≥1-point increase from baseline on CGI-S score (range:1-7), provided that increase results in CGI-S ≥4; 3) deliberate self-injury or injury to others deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis. On PANSS and CGI-S higher scores indicate greater illness.|Baseline to time of relapse (up to 104 weeks)|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Days||Inter-Quartile Range|Median
1274454|NCT00320489|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks|Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274455|NCT00320489|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274456|NCT00320489|Secondary|Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision)|Number of participants who discontinued study participation for any reason (excluding sponsor decision).|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
1274457|NCT00320489|Secondary|Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks|Self-rated scale which measures patient's subjective feelings about taking medications. Each of 10 items is rated as true or false. For items 1, 3, 4, 6, 7, 9, and 10, true is scored as 1; false is scored as 0. For items 2, 5, and 8, true is scored as 0; false is scored as 1. Possible total scores range from 0-10. A subject who answers all 10 questions false will have a score of 3; a subject who answers all 10 questions true will have a score of 7. For 7 out of 10 questions, false is represented by 0, the other 3 questions false is represented by a value=1.|104 weeks|All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274458|NCT00320489|Secondary|Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items)|Self-rated scale which measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1-'very dissatisfied' to 5-'very satisfied'), preference comparing current study medication versus previous medications (scored from 1-'much prefer previous medication' to 5-'much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1-'much less side effects' to 5-'much more side effects'). Range of possible scores is 3-15.|104 weeks|All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274459|NCT00320489|Secondary|Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks|Interviewer-rated 49-item scale used to assess 4 functional domains in patients with schizophrenia : 1) living situation, 2) instrumental activities of daily living, 3) productive activities and role functioning, and 4) social/recreational functioning. Possible responses and scoring vary by item and by domain, with higher scores representing better functioning. Range of possible scores is 1-100. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274460|NCT00320489|Secondary|Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks|Self-rated scale assessing patients' level of alliance with their therapist, including agreement on goals, tasks, and emotional bond. Each of 12 items is rated from 1 ('never') to 7 ('always'), with higher scores indicating greater alliance. Total Scores range from 12-84. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274461|NCT00320489|Secondary|Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks|Interviewer-rated scale that assesses patients' awareness of and insight into their illness. SUMD can either be based on 4 items or 5 items. Items 1 through 4 are rated from 1 (aware) to 5 (unaware); item 5 assesses correct attribution of symptoms to a mental disorder and is rated from 1 (symptoms correctly attributed) to 5 (symptoms incorrectly attributed). Total Scores for Items (1-4) range from 4 to 20 and Total Scores for Items (1-5) range from 5 to 25. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274462|NCT00320489|Secondary|Number of Hospitalization Days|Mean - calculated based on total number of hospitalization days per patient within reporting interval.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Days||Standard Deviation|Mean
1274463|NCT00320489|Secondary|Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study|Number of days of unpaid care, number of days of workdays missed, number of days of paid care per week during the study, post-baseline through 104 weeks.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Days||Standard Deviation|Mean
1274464|NCT00320489|Secondary|Resource Utilization: Number of Outpatient Physician Visits During the Study|Number of outpatient physician visits during the study, post-baseline through 104 weeks.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Outpatient physician visits||Standard Deviation|Mean
1274465|NCT00320489|Secondary|Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks|"Self-rated scale completed by patient's caregiver which measures level of burden placed on the caregiver by caring for the patient. Each of 19 items is rated on a scale from 0 (no impact) to 3 (high negative impact). Total Score range is 0-57. If any of the 19 questions were answered not applicable, then a Total Score of 9 was entered. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline."|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274466|NCT00320489|Secondary|Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks|Generic, multidimensional, health-related, quality-of-life instrument. Overall health status is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274467|NCT00320489|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores|SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains. Domains and scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. There are 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274518|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Primary Diagnosis of MDE|This assessment was completed by the physician at the screening visit. The physician decided which DSM-IV Diagnosis (as shown in outcome measure data table) best characterized the patient's primary diagnosis of MDE.|Screening|D-23 Original + TAU [(n= 330) + (n= 276)]. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.|||Percentage of Patients|||Number
1274468|NCT00320489|Secondary|Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks|Interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning). Total score range is 0-126. Least Squares Mean (LS Mean) values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data were analyzed on ITT basis. ITT analysis: analysis of all randomized patients allocated to the randomized treatment even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on mixed-model repeated measures (MMRM) methodology.|||Units on a Scale||Standard Error|Least Squares Mean
1274469|NCT00320489|Primary|Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)||Baseline up to 104 weeks|All data was analyzed on an intent-to-treat (ITT) basis. An ITT analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Days||Inter-Quartile Range|Median
1274470|NCT00320424|Secondary|Rate of Symptomatic DVT|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Safety population used.|||% of normalized events per participant|||Number
1274471|NCT00320424|Secondary|Summary of Units Transfused|Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||mL|||Number
1274472|NCT00320424|Secondary|Number of Transfused Participants|Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||Participants|||Count of Participants
1274473|NCT00320424|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||Participants|||Count of Participants
1274474|NCT00320424|Secondary|Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)|Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||Participants|||Count of Participants
1274475|NCT00320424|Secondary|Number of Participants With Major Bleeding During Treatment Period|Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall >=2 grams per deciliter (g/dL, 1.6 millimoles per liter [mmol/L]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from >=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) >=2. Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS).|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||Participants|||Count of Participants
1274476|NCT00320424|Secondary|Rate of Distal Only DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used. Only those participants with data available at the indicated time points were analyzed.|||% of normalized events per participant|||Number
1274477|NCT00320424|Secondary|Rate of Proximal DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used. Only those participants with data available at the indicated time points were analyzed.|||% of normalized events per participant|||Number
1274478|NCT00320424|Secondary|Rate of DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used consisted of a subpopulation of safety population who were judged to be evaluable for all DVT and proximal DVT or distal only DVT by the site of occurrence (total/side of operation/opposite side of operation/both sides). Only those participants with data available at the indicated time points were analyzed.|||% of normalized events per participant|||Number
1274479|NCT00320424|Secondary|Rate of PE During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Safety population used which consisted of all participants who received at least one dose of study drug.|||% of normalized events per participant||95% Confidence Interval|Number
1274480|NCT00320424|Primary|Rate of Major Bleeding During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).|From the first study drug injection up to Day 17|Full analysis set used which consisted of all participants who were assigned to study drug with the exception of those who did not receive study drug at all and those with no valid efficacy data (example no evaluable venogram).|||% of normalized events per participant||95% Confidence Interval|Number
1274481|NCT00320411|Secondary|Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants|Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274482|NCT00320411|Secondary|Mean Survivin H Score for All Participants|Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274483|NCT00320411|Secondary|Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants|Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274484|NCT00320411|Secondary|Mean Heregulin H Score for All Participants|Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274485|NCT00320411|Secondary|Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants|Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274586|NCT00319748|Secondary|Mean Difference Values for Soluble CD40 Ligand (sCD40L)|Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|One patient did not have recorded value at 6 hours after treatment and cannot be included in analysis.|||pg/mL||95% Confidence Interval|Mean
1274486|NCT00320411|Secondary|Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants|Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274487|NCT00320411|Secondary|Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants|Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274488|NCT00320411|Secondary|Mean Bcl-2 H Score for All Participants|Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274489|NCT00320411|Secondary|Mean p-BAD H Score for All Participants|Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
1274490|NCT00320411|Secondary|Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants|Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation.|||units on a scale||Standard Deviation|Mean
1274491|NCT00320411|Secondary|Overall Survival|Overall survival was measured as the time between the start of dosing until death, regardless of cause.|Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death.|ITT Population|||weeks||Inter-Quartile Range|Median
1274492|NCT00320411|Secondary|6-month Progression Free Survival|The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing.|Baseline to Month 6 (Week 24)|ITT Population|||percentage of participants|||Number
1274493|NCT00320411|Secondary|4-month Progression Free Survival|The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing.|Baseline to Month 4 (Week 16)|ITT Population|||percentage of participants|||Number
1274494|NCT00320411|Secondary|Time to Response|Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first).|Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.|Participants in the ITT Population achieving a partial or complete response|||Days||Full Range|Median
1274495|NCT00320411|Secondary|Clinical Benefit|Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks.|Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.|ITT Population|||percentage of participants|||Number
1274496|NCT00320411|Secondary|Time to Progression|Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions.|Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.|ITT Population|||weeks||Inter-Quartile Range|Median
1274497|NCT00320411|Secondary|Duration of Response|Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer.|First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.|Participants who achieved defined efficacy|||weeks||Inter-Quartile Range|Median
1274709|NCT00318656|Secondary|Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
1274498|NCT00320411|Primary|Overall Tumor Response|Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.|Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.|Intent-to-Treat (ITT) Population: all participants who had been registered and received at least one dose of the investigational product|||participants|||Number
1274499|NCT00320398|Secondary|Volume of Transfusion|The total volume of transfusion (RBCs or WB) received by the participant was reported.|Up to Day 17|Safety population.|||mL||Standard Deviation|Mean
1274500|NCT00320398|Secondary|Number of Transfused Participants|The number of participants who received RBCs or WB after the total hip replacement surgery within 48 hours of bleed were reported.|Up to Day 17.|Safety population.|||participants|||Number
1274501|NCT00320398|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.|Safety population.|||participants|||Number
1274502|NCT00320398|Secondary|Percentage of Participants With Pulmonary Embolism During Efficacy Period|The percentage of participants with pulmonary embolism (pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia ) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|Safety population.|||percentage of participants|||Number
1274503|NCT00320398|Secondary|Percentage of Participants With Symptomatic DVT During Main Efficacy Period|The percentage of participants with different symptoms of DVT (proximal) like pain or tenderness, swelling, warmth, redness or discoloration, and distention of surface veins, post the total hip replacement surgery were reported, where analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|Safety population.|||percentage of participants|||Number
1274504|NCT00320398|Secondary|Percentage of Participants With Distal Only DVT|The percentage of participants with distal only DVT were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|EEP population. Only those participants with data available at the indicated time points were analyzed.|||percentage participants|||Number
1274505|NCT00320398|Secondary|Percentage of Participants With Proximal DVT|The percentage of participants with DVT (proximal) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|EEP population. Only those participants with data available at the indicated time points were analyzed.|||percentage of participants|||Number
1274506|NCT00320398|Secondary|Percentage of Participants With All Deep Vein Thrombosis (DVT)|The percentage of participants with All DVT were reported, where the analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|Efficacy Evaluable Patients (EEP) included subpopulation of safety participants judged to be evaluable for all DVT, proximal DVT or distal only DVT by site of occurrence (total/ side of operation/ opposite side of operation/ both sides). Only those participants with data available at the indicated time points were analyzed.|||percentage of participants|||Number
1274507|NCT00320398|Secondary|Percentage of Participants With Minor Bleeding|Minor bleeding was defined as the clinically overt bleeding not meeting the criteria for major bleeding like: (Fatal bleed; Including retroperitoneal and intracranial bleeding, or bleed in critical organ [eye, adrenal gland, pericardium, spine]; c) Reoperation due to bleeding or hematoma at operative site; d) Bleeding leading to hemoglobin (Hb) fall > = 2 g/dL(1.6 mmol/L) within 48 hour of the bleed; e)Bleeding that required transfusion of RBCs or WB derived from >= 900 mL of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2), and which were considered more than expected in the clinical context. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.|Up to Day 17|Safety population.|||percentage of participants||95% Confidence Interval|Number
1274786|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|30 min after injection||||Scores on a scale||Full Range|Mean
1274508|NCT00320398|Primary|Percentage of Participants With Major Bleeding|Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall > = 2 gram per deciliter (g/dL)(1.6 millimole per litre [mmol/L]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from >= 900 milliliter (mL) of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.|Up to Day 17|The safety population consisted of all participants who received at least one dose of randomized study drug.|||percentage of participants||95% Confidence Interval|Number
1274509|NCT00320398|Primary|Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period|The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).|Up to Day 17|The Full Analysis Set (FAS) population consisted of all participants who were randomized to either treatment with the exception of: those who did not receive study drug at all; and those with no valid post-randomization efficacy data (e.g., no evaluable venogram).|||percentage of participants||95% Confidence Interval|Number
1274510|NCT00320385|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144.|Baseline, Week 4, Week 12, Week 16, Week 24, and conclusion or withdrawal from study (up to Week 108)|Safety Population: all randomized participants who received >=1 dose of investigational product. The Safety Population was based on the actual treatment received, if this differed from that to which the participant was randomized. Only participants whose overall item response rate was greater than 80% for the FACT-B total score were considered (n).|||scores on a scale||Standard Deviation|Mean
1274511|NCT00320385|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the date of randomization and the earlier of the date of disease progression or death due to breast cancer. Because this outcome measure was confounded by death due to other causes and was similar to PFS, it was not analyzed.|Baseline to disease progression or death or 30 days after last dose (up to 216 weeks)|ITT Population||||||
1274512|NCT00320385|Secondary|Duration of Response (DR)|DR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the first documented evidence of CR or PR until the first documented sign of disease progression or death. Because of the low number of participants experiencing a confirmed response in both treatment arms, analysis for this outcome measure was not performed.|Time from first documented evidence of CR or PR until the first documented sign of disease progression or death or 30 days after last dose (up to 216 weeks)|ITT Population||||||
1274513|NCT00320385|Secondary|Time to Response (TTR)|TTR was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). TTR could not be analyzed because too few participants experienced a confirmed CR or PR.|Baseline until first documented evidence of CR or PR or 30 days after last dose (up to 216 weeks)|ITT Population||||||
1274514|NCT00320385|Secondary|Clinical Benefit Response (CBR)|CBR: percentage of participants with confirmed CR or PR or stable disease (SD) for at least 24 weeks according to RECIST criteria. CR: disappearance of all lesions (target and/or non-target). PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference baseline sum LD, with non-target lesions not increased or absent. SD: neither had sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) in target lesions, taking as reference the smallest sum LD since treatment started; persistence of 1 or more non-target lesions.|Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)|ITT Population|||percentage of participants|||Number
1274515|NCT00320385|Secondary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR was defined as the disappearance of all lesions (target and/or non-target). PR was defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)|ITT Population. Only participants with progesterone receptor status were considered for evaluation.|||percentage of participants|||Number
1274516|NCT00320385|Secondary|Overall Survival (OS)|OS was defined as the time from randomization until death due to any cause. For participants who did not die, OS was censored at the time of last contact.|Baseline to death or 30 days after last dose for the last participant (up to 216 weeks)|ITT Population. Only participants with progesterone receptor status were considered for evaluation.|||weeks||95% Confidence Interval|Median
1274517|NCT00320385|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.|Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)|Intent-to-Treat (ITT) Population: all randomized participants irrespective of whether or not they actually received study treatment. Only participants with progesterone receptor status were considered for evaluation.|||weeks||95% Confidence Interval|Median
1274787|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|Immediately after injection||||Scores on a scale||Full Range|Mean
1274519|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture|"This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's intent of their most recent suicidal gesture or attempt.~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 159 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.|||Percentage of Patients|||Number
1274520|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture|"This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's medical threat to life of their most recent suicidal gesture or attempt.~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 159 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.|||Percentage of Patients|||Number
1274521|NCT00320372|Post-Hoc|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Change From Baseline by Visit Month|The Q-LES-Q-SF is a self-report scale to assess the degree of enjoyment and satisfaction experienced by the patient during the past week. There are 2 forms of this instrument: the short form and the long form. The short form employs the 14 general activities included in the long form, as well as 2 global items. Five-point item scores (1 to 5) are aggregated, with higher scores indicative of greater enjoyment or satisfaction in each domain. The scoring of the Q-LESQ-SF involves summing only the first 14 items to yield a raw total score. The last 2 items are not included in the total score but stand alone. The raw total score ranges from 14 (worst score) to 70 (best score). Higher Q-LES-QSF score indicates more enjoyment and satisfaction (Endicott, Nee et al. 1993).|3-Month Through 60-Month (Post Baseline)|ITT Population minus D-21 Subjects: VNS Therapy Population (D-23=330) + (n= 276) TAU population. The total number of patients in each group is lower than ITT due to missing assessment data, for which a large portion is that of D-21 subjects. The Q-LES-Q-SF was not collected in the D-21 Study.|||units on a scale||Standard Deviation|Mean
1274522|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation|"This assessment was completed telephonically by a third party rater (Central Rater Group). The rating was based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones, which allowed a precise rating of severity. The rater decided whether the rating lied on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5) and then checked the appropriate selection on the MADRS Item 10 Suicidal Thoughts (Ideation).~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|1 Week Pre-Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 2 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.|||Percentage of Patients|||Number
1274523|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Suicides/1000 Person Years)|The number of suicides per calculated 1000 person years.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Number of Suicides Per 1000 Person Years|||Number
1274524|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Number of Suicides)|The number suicides on the study were collected from the baseline visit.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Number of Suicides|||Number
1274525|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (All-Cause Mortality/1000 Person Years)|All cause mortality is defined as the number of deaths per calculated 1000 person years.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Deaths Per 1000 Person Years|||Number
1274526|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Total Patient Years Exposed)|Treatment exposure time in years for all patients for all treatment groups were calculated in 1000 person year measure.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Exposure Per 1000 Patient Years|||Number
1274527|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Total Number of Deaths)|The number of deaths on the study were collected from the baseline visit.|3-Month (baseline or implantation) Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Number of Deaths|||Number
1274528|NCT00320372|Secondary|Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score ≤9 at Visit Month Assessment Post-Baseline)|Remission is a binary outcome response variable (Yes/No Inremission) defined as MADRS total score < 9 at visit month assessment post-baseline. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen and in general it is accepted that a score between 0-6 is indicative of a normal/symptom-free individual; 7-19 is indicative of a patient with mild depression; 20-34 is indicative of a patient with moderate depression; and >34 is indicative of a patient with severe depression. Total number of patients in each group may be lower than ITT in a case of missing assessment data.|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population|||Percentage of Participants|||Number
1274553|NCT00320242|Secondary|Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.|Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).|2-3 months|10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue|||falls per week||Standard Deviation|Mean
1274529|NCT00320372|Secondary|Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS)|"Recurrence based on MADRS is defined as first time attained MADRS total score ≥ 20 after achieving remission. Remission is a binary outcome response variable (Yes/No in-remission) defined as MADRS total score </= 9 at visit month assessment post-baseline. Duration of remission Computed as recorded date of the first recurrence/relapse (MADRS score >/= 20) minus the recorded date of first achieved remission (MADRS score </=9). Only a subpopulation that achieved remission will be included in the summary.~Time-to-event analyses were summarized using Kaplan-Meier curves. Patients who did not achieve recurrence at the end of the study were censored on the last visit date recorded. Additionally, patients who discontinued early were censored on last date of contact. Censored observations and confidence intervals for the estimated median times were calculated."|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population|||Months|Participants|95% Confidence Interval|Median
1274530|NCT00320372|Primary|Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline)|"Response Rate was computed and summarized as the proportion of patients that achieved ≥ 50% reduction from baseline in MADRS total score at each post-baseline visit. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen. A patient was considered a “Responder” (Yes = 1) if achieved ≥ 50% reduction from baseline in MADRS total score at visit month assessment post-baseline. A “Non-Responder” (No = 0) was any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at visit month assessment post-baseline.~Total number of patients in each group may be lower than ITT in a case of missing assessment data."|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population|||Percentage of Participants|||Number
1274531|NCT00320281|Secondary|Rehabilitation Interference Scale (RIS)||2 weeks and 6 weeks post-injection|||||||
1274532|NCT00320281|Secondary|Respiratory Function Measures||2 weeks and 6 weeks post-injection|||||||
1274533|NCT00320281|Secondary|Patient Global Outcome Ratings||2 weeks, 6 weeks, and 6 months post-injection|||||||
1274534|NCT00320281|Secondary|Cervical Range of Motion Measurements||2 weeks and 6 weeks post-injection|||||||
1274535|NCT00320281|Secondary|Beck Depression Inventory||2 weeks and 6 weeks post-injection|||||||
1274536|NCT00320281|Secondary|Modified Leeds Neuropathic Symptoms and Signs Scale||2 weeks, 6 weeks, and 6 months post-injection|||||||
1274537|NCT00320281|Primary|Short-Form McGill Pain Questionnaire||2 weeks, 6 weeks, and 6 months post-injection|||||||
1274538|NCT00320281|Primary|Brief Pain Inventory-SF||2 weeks, 6 weeks, and 6 months post-injection|||||||
1274539|NCT00320281|Primary|Numerical Rating Scale-NRS|"The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the worst possible pain they have experienced and 0 being no pain."|6 weeks post-injection||||units on a scale||95% Confidence Interval|Mean
1274540|NCT00320255|Primary|Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding|"Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:~A decrease in hemoglobin of 20 g/L or more or~Required transfusion of 2 or more units of packed red blood cells or whole blood, or~Occurred in a critical site~Contributed to death.~CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:~Skin hematoma~Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention~Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract~Any other bleeding type that was considered to have clinical consequences."|From first dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274541|NCT00320255|Secondary|Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1274542|NCT00320255|Secondary|Number of Participants With Proximal Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274543|NCT00320255|Secondary|Number of Participants With Distal Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274544|NCT00320255|Secondary|Number of Participants With Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274545|NCT00320255|Secondary|Number of Participants With Nonfatal Pulmonary Embolism|"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug||||Participants||95% Confidence Interval|Number
1274546|NCT00320255|Secondary|Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)|"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274547|NCT00320255|Secondary|Number of Participants With All-Cause Death||First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274548|NCT00320255|Secondary|Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death|"VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274549|NCT00320255|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death|"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274550|NCT00320255|Secondary|Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 30 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274551|NCT00320255|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death|"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
1274552|NCT00320242|Secondary|Percentage Change in Falls|The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.|1 to 2 months|10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue|||% change in fall frequency||Standard Deviation|Mean
1274584|NCT00319839|Primary|Overall Response Rate (Complete and Partial Response)|To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer.|3 years|Analysis was not completed as the study was terminated early due to low accrual and of the 7 subjects who went on study, only 1 completed treatment.||||||
1274554|NCT00320242|Secondary|Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature|Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period|2-3 months|All 26 subjects who entered the study and completed the protocol, so this excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue|||seconds||Standard Deviation|Mean
1274555|NCT00320242|Primary|Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.|The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.|2-3 months|These 13 subjects were those who were reandomized to a 1 month baseline before use of the laserlight visual cue.|||change in FOGQ score||Standard Error|Mean
1274556|NCT00320216|Secondary|Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 28|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Participants|||Number
1274557|NCT00320216|Secondary|Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 32|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Particpants|||Number
1274558|NCT00320216|Secondary|Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12|Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score.|Week 12|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Participants|||Number
1274559|NCT00320216|Primary|Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.|||Participants|||Number
1274560|NCT00320190|Secondary|Median Time to Progression-free Survival|Progression-free survival is defined as the time in days from randomization to progressive disease documented by the investigator or to death from any cause without prior progression. Participants without progressive disease or who do not die and complete the 12-month treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.|Randomization to disease progression or death (to 12 months)|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
1274561|NCT00320190|Secondary|Median Time to Treatment Failure|Time to treatment failure is defined as the time in days from randomization to progressive disease documented by the investigator, to death from any cause without prior progression, or to early treatment discontinuation for any reason, whichever occurs first. Participants without disease progression or who do not die and complete the 12-month study treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.|Randomization to disease progression, death, or discontinuation (to 12 months)|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
1274562|NCT00320190|Secondary|Percentage of Participants With Complete Cytogenetic Response|Cytogenetic response is based on the prevalence of Ph+ metaphases among cells in metaphase in a bone marrow sample.|At 6 and 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
1274563|NCT00320190|Secondary|Median Time to MMolR|Time to MMolR is defined as the time from first treatment dose until measurement criteria are first met for MMolR. MMolR is defined as a reduction in transcript levels of the BCR-ABL gene of at least 3 log from baseline.|At 3, 6, 9, and 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
1274564|NCT00320190|Secondary|Percentage of Participants With On-study AEs of Special Interest|GI=gastrointestinal. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Grade 1=mild; Grade 2=moderate; Grade 3=severe and undesirable; Grade 4=life-threatening or disabling; Grade 5=death. Percentages based on the number of participants with a specific grade at baseline. Participants without on-study test values for a particular laboratory analyte are not included in the reporting of that analyte.|Months 1 to 12, continuously, and Months 12 to 24, continuously|All participants who received at least 1 dose of dasatinib or imatinib.|||Percentage of Participants|||Number
1274788|NCT00317941|Secondary|Percentage of Injection Sites Without Pain Reported by Participants||Up to 3 months assessed 24 hours after each injection||||Percentage of injection sites|Participants||Number
1274565|NCT00320190|Secondary|Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, persistent or significant disability/incapacity, drug dependency, or drug abuse; prolongs inpatient hospitalization; or is life-threatening, a congenital anomaly/birth defect, or an important medical event. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Months 1 to 12, continuously, and Months 12 to 24, continuously|All participants who received at least 1 dose of dasatinib or imatinib.|||Percentage of participants|||Number
1274566|NCT00320190|Primary|Percentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR)|MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.|At 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
1274567|NCT00320112|Secondary|Number of Participants With Insulin Starts at 6 Months|the number of insulin starts at 6 months from baseline.|6 months (baseline to 6 months follow-up)|medical charts were reviewed to obtain this information and all participant charts were reviewed|||participants|||Number
1274568|NCT00320112|Secondary|Change in Diastolic Blood Pressure|change in diastolic blood pressure was measured at 6 months|6 months from baseline|As noted earlier, for physiologic measures only 113 of the 125 peer support participants were able to provide 6 month follow-up data and 103 of 119 nurse management group provided 6 month follow-up data.|||mmHg||Standard Deviation|Mean
1274569|NCT00320112|Secondary|Change in Systolic Blood Pressure Measure|secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months|change in blood pressure at 6 months|comparison of blood pressure measure taken at baseline and then again at 6 months among the two groups. as noted, 113 peer support participants provided physiologic measures at 6 months and 103 of 119 from the nurse management group provided physiologic measures at 6 months.|||mmHg||Standard Deviation|Mean
1274570|NCT00320112|Primary|Change in Glycemic Control (HbA1c)|The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.|6 months (baseline to 6 months)|Peer Support group: 117 of the 125 provided 6 month data and 113 provided physiologic measures. Nurse Case management participants: 114 of 119 provided 6 month data and 103 provided follow-up physiologic measures.|||percent HbA1c||Standard Deviation|Mean
1274571|NCT00319982|Secondary|Impact of Diltiazem on Systolic Blood Pressure|Change in Value (Difference between Final and Baseline Visits)|Baseline and final study visits||||mmHg||Standard Error|Mean
1274572|NCT00319982|Secondary|Adherence to Study Medication|Adherence to study medication was assessed by pill count|Duration of the trial||||percentage of pills taken||Standard Deviation|Median
1274573|NCT00319982|Secondary|Development of Left Ventricular Hypertrophy|The number of participants who developed overt left ventricular hypertrophy during the duration of the trial was analyzed|Baseline through final study visits||||participants|||Number
1274574|NCT00319982|Secondary|Left Ventricular Cavity Size|Change in Left Ventricular End-Diastolic Diameter z-score (Final Value - Baseline Value)|Baseline and final study visits||||z-score units||Standard Error|Mean
1274575|NCT00319982|Secondary|Impact of Diltiazem on Heart Rate|Change in Value (Difference between Final and Baseline Visits)|Baseline and final study visits||||beats/minute||Standard Error|Mean
1274576|NCT00319982|Secondary|Safety and Tolerability of Diltiazem Treatment|Adverse events were compared between participants assigned to diltiazem and those assigned to placebo|Baseline through final study visits||||Participants Reporting Adverse Events|||Number
1274577|NCT00319982|Primary|Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity|The change in E' velocity (difference between final value - baseline value) was compared between participants who received diltiazem and those who received placebo to gauge treatment response. Please note that the total duration on treatment varied between study subjects to maximize time on treatment for the trial. Specifically, subjects that enrolled earliest had the longest duration of treatment; those who enrolled latest had the shortest duration of treatment with a minimum treatment duration of 1 year. All analyses examine the final study visit on treatment to the baseline visit.|Baseline and final study visits||||cm/sec (difference final-baseline)||Standard Error|Mean
1274578|NCT00319956|Other Pre-specified|Participant Mortality|Data will be collected on the number of participants that did not survive to discharge from the NICU. Data are presented as the percent of participants that did not survive.|Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks||||percentage of mortality|||Number
1274579|NCT00319956|Other Pre-specified|Number of Days on Mechanical Ventilation|Participants will be placed on mechanical ventilation as necessary based on standard of care. Data are presented as the percent of participants in each group receiving mechanical ventilation.|Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks||||days||Standard Deviation|Mean
1274580|NCT00319956|Other Pre-specified|Postnatal Steroid Use|Steroids will be provided as needed based on Standard of Care. Data are presented as the percent of participants that received steroids between birth and discharge from the NICU.|Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks||||percentage of participants|||Number
1274581|NCT00319956|Primary|Incidence of Bronchopulmonary Dysplasia (BPD)|comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups.|diagnosis of BPD at 36wks corrected gestational age|Mortality was 18% in the Azithromycin group and 22% in the Placebo group, thus 91 participants in the Azithromycin group and 85 participants in the Placebo group were analyzed.|||percentage w/ BPD|||Number
1274582|NCT00319839|Secondary|Overall Survival and Progression-free Survival in Patients||3 years|||||||
1274583|NCT00319839|Secondary|Frequency and Severity of Toxicities|To assess the frequency and severity of toxicities associated with this treatment.|3 years|Analysis was not completed as the study was terminated early due to low accrual and of the 7 subjects who went on study, only 1 completed treatment.||||||
1274587|NCT00319748|Secondary|Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)|Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Two patients did not have recorded values at 6 hours after treatment so cannot be included in analysis.|||pg/mL||95% Confidence Interval|Mean
1274588|NCT00319748|Secondary|Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)|Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Only 5 patients had a value reported at 6 hours after treatment.|||pg/mL||95% Confidence Interval|Mean
1274589|NCT00319748|Secondary|Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)|Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|One patient did not have a value reported at 6 hours after treatment so cannot be included in analysis.|||pg/mL||95% Confidence Interval|Mean
1274590|NCT00319748|Secondary|Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)|Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 hours after Dose 1|One patient did not have value reported at 6 hours after treatment, so cannot be included.|||pg/mL||95% Confidence Interval|Mean
1274591|NCT00319748|Primary|Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.|Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.|after 12 weeks (24 doses of 852A)|Includes only patients that received all 24 doses of 852A.|||Participants|||Number
1274592|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Histology: Squamous Cell|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB|||percentage of participants|||Number
1274593|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB|||percentage of participants|||Number
1274594|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: III|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with Stage III disease|||percentage of participants|||Number
1274595|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: IIB|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB|||percentage of participants|||Number
1274596|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: IIA|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIA|||percentage of participants|||Number
1274597|NCT00319735|Secondary|Perform Exploratory Molecular Correlates.|To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy.|36 months|No data was collected or analyzed for this secondary objective.||||||
1274598|NCT00319735|Secondary|Evaluate Toxicity|To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|Grade 3 toxicities occurring in >5% of participants are reported. Safety data is presented in totality in the adverse events section.|||participants|||Number
1274599|NCT00319735|Secondary|Time to Relief of Dysphagia|To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab|36 months|No data was collected or analyzed for this secondary objective.||||||
1274600|NCT00319735|Secondary|Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.|"To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas that underwent esophagectomy.~Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction."|Up to 36 months|Participants who underwent esophagectomy|||percentage of participants||95% Confidence Interval|Number
1274601|NCT00319735|Primary|Complete Pathologic Response (pCR)|"To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas.~Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction."|36 months||||percentage of participants|||Number
1274602|NCT00319696|Secondary|Adverse Events Leading to Permanent Discontinuation of the Study Medication|Number of patients with an adverse event leading to permanent discontinuation of the study treatment|80 weeks|Study population|||participants|||Number
1274603|NCT00319696|Secondary|Adverse Events up to 24 Hours After Last Study Medication|Number of patients with at least one treatment-emergent adverse event. All adverse events that occurred after study drug initiation and up to 24 hours after study drug discontinuation were to be recorded.|80 weeks|Study population|||participants|||Number
1274604|NCT00319696|Primary|Total Number of New Digital Ulcers (DUs) Per Patient Observed by the Investigator at Planned Visits|The total number of new DUs per patient observed by the investigator at planned visits and new transient DUs recorded in the patient diary (a patient diary was used to record DUs that might appear and disappear between two planned visits) were assessed at each clinic visit|At planned visits up to week 80|One patient did not have a DU at baseline (number of patients assessed at Weeks 0-4,4-8,8-16,16-24,24-32,32-40,40-48,48-56,56-64,64-72, and 72-80 were 114, 107, 103, 100, 97, 94, 88, 87, 86, 86, and 83, respectively.|||number of new digital ulcers|||Number
1274789|NCT00317941|Secondary|Percentage of Injection Sites Without Pain Reported by Physicians||Up to 3 months||||Percentage of injection sites|Participants||Number
1274605|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in the UK Systemic Sclerosis Functional Score (UKFS)|UKFS relates to upper and lower extremity function and muscle weakness. For each item, the patient indicated the responses that best described their current ability: “able to perform in a normal manner,” “able to perform with alteration in style,” “can only manage with difficulty,” and “impossible to achieve.” Each response was given an integer from 0 (able to perform in a normal manner) to 3 (impossible to achieve), and the sum of individual responses provided an overall score of 0 to 33. Missing values were replaced with the worst value the patient reported on the other items at that visit.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 98, 93, 84, 82, and 78, respectively|||score on a scale||Standard Deviation|Mean
1274606|NCT00319696|Primary|Mean Changes From Baseline at Each 16 Week Interval up to Week 80 in Overall Hand Pain Related to Finger Ulcers|Overall hand pain related to finger ulcers was assessed by the patient using a Visual Analogue Scale. Patients were instructed to score their pain by marking on the continuous 10-cm scale, where 0 (left) was no pain and 100 (right) very severe pain, in response to the question, “How much pain have you had because of your finger ulcers in the past week?” The investigator measured the distance in millimeters between 0 and the patient mark with the ruler provided and recorded the distance.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 110, 94, 89, 81, 76, and 73, respectively|||mm||Standard Deviation|Mean
1274607|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Activity|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
1274608|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Grip|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
1274609|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Reach|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
1274610|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Hygiene|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
1274611|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Walking|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
1274612|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Eating|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
1274613|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Arising|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
1274614|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Dressing|SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: “without any difficulty”, “with some difficulty,” “with much difficulty,” or “unable to do,” equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
1274615|NCT00319696|Primary|Time to Complete Healing of Each New DU||New DU occurence to healing|Complete healing of each new DU was not calculated due to the lack of effect on healing variables seen in the previous placebo-controlled study (RAPIDS 2). In consequence, the endpoint on DU healing originally planned time to complete healing of new DUs was not evaluated.||||||
1274616|NCT00319696|Primary|Time to Complete Healing of Each Baseline DU||Baseline to healing|Complete healing of each baseline was not calculated due to the lack of effect on healing variables seen in the previous placebo-controlled study (RAPIDS 2). In consequence, the endpoint on time to complete healing of baseline DUs was not evaluated.||||||
1274617|NCT00319644|Primary|Antibiotics Exposure Days|We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure|15 days|Random|||days||Standard Deviation|Mean
1274618|NCT00319644|Primary|Change in Antibiotic Usage or Exposure|We expect that 100-110 adult patients will have clinically suspected VAP over a 2-year period. We assume that 50 patients with suspected VAP will be randomized to mini-BAl, and 50 patients will be randomized to tracheal aspirate. We expect that patients randomized to tracheal aspirate group will receive an average of approximately 14 total days of antibiotics over their ICU stay. This study will have >80% power to detect a difference of 4 days of antibiotics (i.e. average of 10 days in mini-BAL group) with a 7-day standard deviation in both groups (alpha error level 5%).|It is theorized that patients randomized to the tracheal aspirate will receive an average of 15 days of antibiotics while patients randomized under the minibal arm will receive an average of 10 days of antibiotics|Of the 37 adult critically ill patients, 21 belonged to the tracheal aspirate (TA) group and 16 patients were classified as mini-BAL (MB) group.|||days||Standard Deviation|Mean
1274619|NCT00319592|Primary|Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®|Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.|Day 0 up to Day 6 post-vaccination|Adverse events were assessed in all participants who received at least one dose of study vaccine pr saline (Intent to Treat Population).|||Participants|||Number
1274620|NCT00319592|Primary|Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) up to month 12 post-vaccination|Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).|||1/dilutions||Standard Deviation|Mean
1274621|NCT00319592|Primary|Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']|Day 0 (Pre-vaccination) and up to Month 12 After First Dose|Seropositive status was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).|||Participants|||Number
1274622|NCT00319592|Primary|Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).|Day 0 up to Day 56 post-vaccination|Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per Protocol Population).|||1/dilutions||Standard Deviation|Mean
1274623|NCT00319592|Primary|Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.|Day 0 (pre-vaccination) and up to Day 56 post-vaccination|Seroconversion was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).|||Participants|||Number
1274624|NCT00319553|Primary|Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Geometric mean concentration of antibody to the pertussis antigens were analyzed in the per-protocol population|||EU/mL||95% Confidence Interval|Geometric Mean
1274625|NCT00319553|Primary|Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Diphtheria antitoxin concentrations were analyzed in the per-protocol population|||Percentage of Participants|||Number
1274626|NCT00319553|Primary|Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Tetanus antitoxin concentrations were analyzed in the per-protocol population.|||Percentage of Participants|||Number
1274627|NCT00319553|Primary|Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®|"Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities."|Day 0 to 7 post-vaccination|Solicited injection site and Systemic reactions were analyzed in the intent-to-treat safety population|||Participants|||Number
1274628|NCT00319501|Secondary|Mean Score on Physician Global Treatment Assessment During the Open-label Period|Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period and who were available for evaluation.|||Units on a scale||Standard Deviation|Mean
1274629|NCT00319501|Secondary|Mean Score on Caregiver Global Treatment Assessment During the Open-label Period|Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|Assessments completed at the end of each treated episode of ARS in the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period and who were available for participation.|||Units on a scale||Standard Deviation|Mean
1274630|NCT00319501|Secondary|Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period|Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.|||Participants|||Number
1274631|NCT00319501|Secondary|Number of Participants Requiring Emergency Department Visits During the Open-label Period|Any use of emergency treatment (such as an emergency room visit) was recorded in the patient’s diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself.|From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period.|||Participants|||Number
1274632|NCT00319501|Secondary|Number of Participants Requiring Rescue Medication During the Open-label Period|Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode.|From 15 minutes to 12 hours after study drug administration during the Open-label Period|All randomized participants in whom an attempt (successful or not) was made to administer study drug for an ARS episode during the Open-label Period of the study.|||Participants|||Number
1274633|NCT00319501|Secondary|Mean Score on Physician Global Treatment Assessment During the Double-blind Period|Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes. The physician global evaluation is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|At Visit 2 and subsequent visits in the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.|||Units on a scale||Standard Deviation|Mean
1274634|NCT00319501|Secondary|Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period|Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|Assessments completed at the end of each treated episode of ARS in the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.|||Units on a scale||Standard Deviation|Mean
1274790|NCT00317941|Secondary|Percentage of Participants Without Pain Reported by Participants||Up to 3 months assessed 24 hours after each injection||||Percentage of participants|||Number
1274635|NCT00319501|Secondary|Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period|Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.|||Participants|||Number
1274636|NCT00319501|Secondary|Number of Participants Requiring Emergency Department Visits During the Double-blind Period|Any use of emergency treatment (such as an emergency room visit) was recorded in the patient’s diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.|||Participants|||Number
1274637|NCT00319501|Secondary|Number of Participants Requiring Rescue Medication During the Double-blind Period|If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the acute repetitive seizure (ARS) episode. Each patient's specific criteria for seizure and an episode of ARS were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS during the Double-blind Period.|||Participants|||Number
1274638|NCT00319501|Primary|Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period|An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period.|||Percentage of participants|||Number
1274639|NCT00319501|Primary|Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)|An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.|||Hours||95% Confidence Interval|Median
1274640|NCT00319449|Secondary|High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg|12-hour fasting blood samples were collected in participants and the high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol was measured with the basic lipid panel test.|6 weeks post treatment|Participants who completed the study.|||mg/dL||95% Confidence Interval|Mean
1274641|NCT00319449|Secondary|Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)|12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5] after treatment for 6 weeks.|6 weeks post treatment|Participants who completed the study.|||Participants|||Number
1275987|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|2 years||||Percentage of participants|||Number
1274642|NCT00319449|Primary|Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg|12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5]) before and after treatment.|Baseline and 6 weeks|Participants who completed the study.|||mg/dL||95% Confidence Interval|Mean
1274643|NCT00319436|Secondary|Maternal Substance Abuse (Assessed With Urine Toxicology Screens)|Maternal substance use was monitored weekly using results from weekly urine toxicology (UTOX) screens testing for presence of opiate, cocaine, and cannabis metabolites in urine samples collected at the outpatient clinic. For each month of the mother’s participation in the study, a mother received a score of “0” if no drug metabolites were present in any of her urine toxicology screens during that month or a score of “1” if one or more of her urine toxicology screens tested positive for a drug metabolite during that month. A percentage was calculated by= number of positive substance tests/number of total test *100 for each patients during each month.|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||% positive utox screens/month||Standard Error|Mean
1274644|NCT00319436|Secondary|Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)|The Brief Symptom Inventory (BSI; Derogatis, 1993) was used to assess maternal global psychiatric distress. The BSI is a standardized, widely used, 53-item, 5-point, self-report measure of psychopathology. The composite Global Severity Index (GSI) measures current overall symptomatology across multiple domains and has demonstrated good reliability and validityT-scores have a mean of 50 and a standard deviation of 10. Scores within one standard deviation (ie. a T-score of 10) above the mean on any dimension are regarded as being within the normal range on that dimension (Derogatis, 1993). These scores were converted to T-scores using data from the scoring manual. The higher the scores are worse.T scores above 60 on the GSI indicate risk for a clinical disorder.|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
1274645|NCT00319436|Secondary|Maternal Depression (Measured With the Beck Depression Inventory)|The Beck Depression Inventory (BDI; Beck, Steer, & Brown, 1996) was used to assess maternal symptoms of depression. The BDI is a widely used 21-item questionnaire rated on a 4-point scale and yields a total score ranging from 0 to 63: scores between 13 and 19 indicate mild depression; scores between 20 and 28 indicate moderate levels of depression, and scores between 29 and 63 indicate severe levels of depression (Beck et al., 1996).|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
1274646|NCT00319436|Secondary|Child Behavior (Assessed With the NCAST Teaching Scales)|Child behavior with the mother was assessed using the Clarity of Cues and the Responsiveness to Caregiver Subscales from the NCAST Teaching Scales. The Child Total Score is the sum of the 2 scales (23 items) with scores ranging from 0 to 23. The Child Contingency Score is the sum of 12 contingent items from the 2 scales (with scores ranging from 0 - 12). The 2 subscores are summed to arrive at the composite score. Higher scores are better. The normative means for the children of high school educated mothers reported in the scoring manual: Total Child Score = 15.44 (4.29), Clarity of Cues = 7.99 (1.49), Responsiveness to Parent = 7.45 (3.16).|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
1274647|NCT00319436|Secondary|Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)|Mothers choose a task to teach the child in a 5 minute teaching session. Maternal behavior is coded on 4 dimensions: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, & Cognitive Growth Fostering. The Total Caregiver Score is the sum of the 4 subscale scores (73 items) with scores ranging from 0 to 73. The Total Caregiver Contingency Score is the sum of 20 items from the 4 subscales that involve the caregiver’s contingent response to child cues (scores range from 0 to 20). Higher score are better and lower scores are worse. For mothers with high school education (which a majority in our sample had) here are the normative means (SDs) reported in the scoring manual: Total Caregiver Score = 40.69 (6.85), Sensitivity to Cues = 9.16 (1.62), Response to Distress = 10.04 (1.78), Social-Emotional Growth = 8.99 (1.83), Cognitive Growth = 12.51 (3).|post-treatment, 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
1274648|NCT00319436|Primary|Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)|The Working Model of the Child Interview (WMCI; Zeanah & Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother’s perceptions of her child and their relationship. The rater was trained to reliably code 6 qualitative subscales: Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.|post-treatment, 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
1274649|NCT00319436|Primary|Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)|The Parent Development Interview (PDI) was used to measure maternal capacity to mentalize about her own and her child’s behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother’s narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.|post-treatment and 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
1274650|NCT00319254|Other Pre-specified|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 2, 7, 20 hours post-dose on Day 1 of Week 4 and pre-dose on Day 1 of Weeks 1, 8, 12, 16, and 24|||||||
1274651|NCT00319254|Secondary|Change From Baseline in Karnofsky Performance Status (KPS) at Week 1, 4, 8, 12, 16, Every 8 Weeks Thereafter and 14 Days After Last Dose of Study Treatment|KPS: 11 level score ranged 100 to 0, to assess functional impairment. 100:Normal; 90:Able to carry on normal activity; 80:Normal activity with effort, some signs or symptoms of disease; 70:Cares for self, unable to carry on normal activity or to do active work; 60:Requires occasional assistance but is able to care for most of needs; 50:Requires considerable assistance and frequent medical care; 40:Disabled,requires special care and assistance; 30:Severely disabled; hospitalization indicated although death is not imminent; 20:Very sick; 10:Morbibund,fatal processes progressing rapidly; 0:Death.|Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment|Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.||||||
1274652|NCT00319254|Secondary|Concomitant Medications Used for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Study Day 1 to last dose of study treatment (Week 77) as a management of an AE were to be reported.|Day 1 up to end of treatment (Week 77)|Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.||||||
1274653|NCT00319254|Secondary|Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations|Number of participants with potentially clinically significant (PCS) vital signs and physical examinations are reported. Criteria for PCS vital signs include: respiratory rate >25 breaths/minute and PCS physical examinations include: an increase or decrease from baseline of >=7% in body weight.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."|||participants|||Number
1274654|NCT00319254|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG)|Number of participants with potentially clinically significant (PCS) ECG findings are reported. Criteria for PCS ECG findings include: no sinus rhythm; heart rate >=120 beats per minute (bpm) or increase >=15 bpm; QT interval corrected using Bazett's formula (QTcB) >60 milliseconds (msec) change from baseline; and overall ECG evaluation not normal.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."|||participants|||Number
1274655|NCT00319254|Secondary|Number of Participants With Change From Baseline in Laboratory Test Results|Number of participants with potentially clinically significant (PCS) laboratory values are reported. Criteria for PCS laboratory values include: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); total bilirubin >3*ULN micromole/L; sodium <130, magnesium <0.4 and >1.23 millimole/L; lipase >2*ULN microkats/L; neutrophils <1*10^9/L. Participants meeting at least 1 PCS criteria are reported.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."|||participants|||Number
1274656|NCT00319254|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as a confirmed CR or PR, or stable disease (SD) for more than (>) 24 weeks as the best response before the first evidence of progressive disease (PD). A participant demonstrating CR, PR, or SD >24 weeks at any time while on study was counted in the numerator.|Baseline up to end of treatment (Week 77)|ITT population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1274657|NCT00319254|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was based on the assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to sponsor modified Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions. Confirmed PR defined as more than or equal to (>=) 30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline up to Year 1|ITT population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1274658|NCT00319254|Secondary|Overall Survival (OS)|OS was estimated by Kaplan-Meier method. Survival was defined as the time period from the date of first dose of study treatment to the date of death, censored at the participant's last contact date. Percentage of participants who were still alive at 2 years is reported.|Baseline up to Year 2|ITT population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1279965|NCT00270855|Secondary|Total Cholesterol (TC) Between Groups|Comparison of TC between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
1274659|NCT00319254|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 30 days after last dose of study treatment|Safety population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1274660|NCT00319254|Primary|Progression-Free Survival (PFS) Rate|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.|Baseline up to Week 16|Intent-To-Treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1274661|NCT00319111|Secondary|Occurrence of Liver Function Test and Hemoglobin Abnormality|Number of patients with an increase in liver aminotransferases to >3 times upper limit of normal (ULN) or a decrease in hemoglobin concentration to ≤10 g/dL|Until discontinuation of study drug, up to 3.3 years|study population|||participants|||Number
1274662|NCT00319111|Secondary|Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation||28 days after discontinuation of study drug, up to 3.3 years|Study population|||participants|||Number
1274663|NCT00319111|Secondary|Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication||Until discontinuation of study drug, up to 3.3 years|Study population|||participants|||Number
1274664|NCT00319111|Primary|Time to Clinical Worsening up to End-of-study|An event of clinical worsening was defined as death during the treatment period, a treatment-emergent adverse event that led to permanent discontinuation of study treatment and with outcome death, hospitalization due to worsening pulmonary hypertension, or lung transplantation. Patients are censored at 1 day after the end of treatment or at day of pulmonary endarterectomy if earlier.|Until discontinuation of study drug, up to 3.3 years|Study population|||participants|||Number
1274665|NCT00319111|Primary|Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)|"Disease severity was assessed by WHO classification of PH criteria:~Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope.~Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.~Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.~Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA."|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 138, 129, 123, 109, and 139 respectively|||participants with improved WHO class|||Number
1274666|NCT00319111|Primary|Change From Baseline to All Assessed Time Points in Borg Dyspnea Index|Maximal dyspnea during the walk test was assessed by the patient using the Borg dyspnea index. Immediately following each walk test, patients rated perceived maximal breathlessness during the walk test on a 12-point scale (0 [nothing at all], 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 [maximum ever experienced]).|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 136, 127, 120, 105, and 136 respectively|||Scores on a scale||Standard Deviation|Mean
1274667|NCT00319111|Primary|Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance|Exercise capacity was assessed using the 6MWT. Area used for testing had to be a minimum of 30m in length and 2-3m in width, with 3m gradations. Areas were well ventilated with air temperature controlled. The test was administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6min period. If the test was stopped before 6 minutes, the main reason for stopping the test was recorded. The tester measured the distance walked by patients during the timed 6min period.|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 137, 128, 121, 106, and 137 respectively|||walk distance change from baseline (m)||Standard Deviation|Mean
1274668|NCT00319098|Secondary|Number of Seroprotected Subjects Against A/Vietnam Influenza Strain|Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.|At Day 0 (PRE), Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.|||Participants|||Count of Participants
1274669|NCT00319098|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.|At Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.|||Titer fold increase||95% Confidence Interval|Geometric Mean
1274691|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Body Weight|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including growth as measured by changes from baseline in body weight and height.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||kg||Full Range|Median
1274670|NCT00319098|Secondary|Number of Seroconverted Subjects Against H5N1|Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.|At Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.|||Participants|||Count of Participants
1274671|NCT00319098|Secondary|Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1|Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).|At Day 0 (PRE), 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1274672|NCT00319098|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Day 51|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available at Day 51.|||Participants|||Count of Participants
1274673|NCT00319098|Primary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Day 180|The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.|||Participants|||Count of Participants
1274674|NCT00319098|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Day 180|The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.|||Participants|||Count of Participants
1274675|NCT00319098|Primary|Number of Subjects With AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.|During the 30 Day (Days 0-29) post Dose 2|The analysis was performed on the TVc which included all subjects who had received the second dose and for whom data were available.|||Participants|||Count of Participants
1274676|NCT00319098|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.|During the 21st Day (Days 0-20) post Dose 1|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in at Day 51.|||Participants|||Count of Participants
1274677|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Across Doses)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) post vaccination across dosses|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Participants|||Count of Participants
1274678|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Dose 2)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) after Dose 2|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Participants|||Count of Participants
1274679|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Dose 1)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) after Dose 1|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Participants|||Count of Participants
1274791|NCT00317941|Secondary|Percentage of Sites Developing a Severe Reaction 48 Hours After Injection|An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis|Up to 3 months assessed every 48 hours after each injection||||Percentage of sites|Participants||Number
1274680|NCT00319098|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter|During a 7 day follow-up period after each dose of vaccine and overall.|The analysis was performed on the Total Vaccinated cohort (TVc) which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Participants|||Count of Participants
1274681|NCT00319046|Secondary|Mean Percent Change From Baseline in Spleen Volume|"Spleen volume was assessed at baseline and end of treatment by magnetic resonance imaging.~Imputation methods for patients with missing values at Month 24 were applied as follows: if a patient had at least 640 days of treatment with the study drug, the last observation that was not more than 2 days after the end of treatment was carried forward. If a patient had discontinued study drug before Day 640, the ‘worst’ within-patient value not more than 2 days after the end of treatment was used to impute the missing value."|End of treatment (Month 24)|The analysis was performed on those non-splenectomized patients who had a post-baseline assessment of spleen volume while on treatment with miglustat|||Percentage change||Standard Deviation|Mean
1274682|NCT00319046|Secondary|Spleen Volume at Baseline and End of Treatment|"Spleen volume was assessed at baseline and end of treatment by magnetic resonance imaging.~Imputation methods for patients with missing values at Month 24 were applied as follows: if a patient had at least 640 days of treatment with the study drug, the last observation that was not more than 2 days after the end of treatment was carried forward. If a patient had discontinued study drug before Day 640, the ‘worst’ within-patient value not more than 2 days after the end of treatment was used to impute the missing value."|Baseline and end of treatment (Month 24)|The analysis was performed on those non-splenectomized patients who had a post-baseline assessment of spleen volume while on treatment with miglustat|||cm^3||Standard Deviation|Mean
1274683|NCT00319046|Primary|Mean Within-patient Percent Change From Baseline in Liver Volume|Liver volume was assessed at baseline and end of treatment by magnetic resonance imaging. Imputation methods for patients with missing values at Month 24 were applied as follows: if a patient had at least 640 days of treatment with the study drug, the last observation that was not more than 2 days after the end of treatment was carried forward. If a patient had discontinued study drug before Day 640, the ‘worst’ within-patient value not more than 2 days after the end of treatment was used to impute the missing value.|End of treatment (Month 24)|One patient was excluded from analysis as the baseline liver volume not available|||Percentage change||Standard Deviation|Mean
1274684|NCT00319046|Primary|Liver Volume at Baseline and at End of Treatment|Liver volume was assessed at baseline and end of treatment by magnetic resonance imaging. Imputation methods for patients with missing values at Month 24 were applied as follows: if a patient had at least 640 days of treatment with the study drug, the last observation that was not more than 2 days after the end of treatment was carried forward. If a patient had discontinued study drug before Day 640, the ‘worst’ within-patient value not more than 2 days after the end of treatment was used to impute the missing value.|Baseline and end of treatment (Month 24)|One patient was excluded from analysis as the baseline liver volume not available|||cm^3||Standard Deviation|Mean
1274685|NCT00319020|Primary|Number of Subjects With Adverse Events Leading to Premature Discontinuation of Study Treatment||From the first study drug administration in FUTURE 1, for an average of 31 months||||Participants|||Number
1274686|NCT00319020|Primary|Proportion of Patients With Treatment-emergent Hemoglobin Abnormalities|"The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including hemoglobin abnormalities.~Proportion of patients with marked hemoglobin decreases (i.e., decrease of or above 15% of the lower normal limit (LL)) is reported here."|After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||Percentage of participants|||Number
1274687|NCT00319020|Primary|Proportion of Patients With Treatment-emergent Liver Function Abnormalities|"The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including laboratory abnormalities related to liver enzymes.~Proportion of patients with increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN) is reported here."|After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||Percentage of participants|||Number
1274688|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Pulse Rate|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in pulse rate.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||Beats per minutes||Full Range|Median
1274689|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Diastolic Blood Pressure (DBP)|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||mmHg||Full Range|Median
1274690|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Systolic Blood Pressure (SBP)|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||mmHg||Full Range|Median
1274692|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Height for Age.|"In order to compare the growth data with those of healthy children, growth curves are calculated from height data collected throughout the follow-up period. For each patient, height measured at each study visit was converted to a z-score and expressed in standard deviations (SD) from WHO growth standards. The Z-score was calculated according to the following formula:~Z-score = (observed value of the study participant - median value of the reference population) / SD value of the reference population"|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||Z-score||Full Range|Median
1274693|NCT00318929|Secondary|Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ)|Seizure Severity Questionnaire summary score, on a scale of 1 to 7 with one being the least severe and 7 being the most severe, components of seizures include; warning, activity and recovery|24 weeks|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.||||||
1274694|NCT00318929|Secondary|Number of Seizures Per Month|Count of seizures per month determined by seizures recorded in diaries.|24 weeks|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.||||||
1274695|NCT00318929|Secondary|Patient's Compliance With Once a Day Dosing.|Subjects pill count for once a day dosing and compliance with medication as a percent of total doses prescribed.|24 weeks|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.||||||
1274696|NCT00318929|Primary|Effectiveness of Medication as Measured by Participation Through the End of the Trial.|Number of participants completing the trial|24 weeks||||participants|||Number
1274697|NCT00318812|Secondary|Transferrin Saturation|Comparison of Transferrin Saturation between the Groups|6 Months||||percentage of bound iron sites||Inter-Quartile Range|Median
1274698|NCT00318812|Secondary|Ferritin|Comparison of Ferritin at 6 months between the 2 Groups|6 months||||ug/L||Inter-Quartile Range|Median
1274699|NCT00318812|Primary|Hemoglobin Concentration at 6 Months||6 months||||g/L||Inter-Quartile Range|Median
1274700|NCT00318708|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|The Asthma Quality of Life Questionnaire (AQLQ) consists of 32 questions, with each question ranging from 1 (worst) to 7 (best). The 32 questions are averaged to yield an overall score, which is reported here. Therefore, a positive change between the 16-week score and the baseline score represents improvement.|the week-16 value minus the baseline-value|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||units on a scale (1 through 7)||Standard Error|Least Squares Mean
1274701|NCT00318708|Secondary|Exhaled Nitric Oxide (eNO)|Exhaled nitric oxide (eNO) measured in parts per billion|the week-16 value minus the baseline-value|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||parts per billion||Standard Error|Least Squares Mean
1274702|NCT00318708|Secondary|Methacholine Provocative Concentration (PC20)|Logarithm-base 2 transformed Methacholine provocative concentration (PC20) based on FEV1|the week-16 value minus the baseline-value|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||logarithm-base 2 of mg/mL||Standard Error|Least Squares Mean
1274703|NCT00318708|Secondary|Forced Expiratory Volume in One Second (FEV1)|Forced expiratory volume in one second (FEV1) from spirometry|the week-16 value minus the baseline-value|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||Liters||Standard Error|Least Squares Mean
1274704|NCT00318708|Secondary|AM Peak Expiratory Flow (PEF)|daily AM peak expiratory flow (PEF) measured in liters per minute|the week-16 average minus the baseline-week average|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||liters per minute||Standard Error|Least Squares Mean
1274705|NCT00318708|Secondary|Asthma Rescue Medication Use|number of rescue puffs per day|the week-16 average minus the baseline-week average|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||rescue puffs per day||Standard Error|Least Squares Mean
1274706|NCT00318708|Primary|Juniper Asthma Control Questionnaire (ACQ) Results|The Juniper asthma control questionnaire (ACQ) consists of six questions answered by the asthma patient with respect to symptoms, rescue medication use, and night-time awakenings due to asthma. A seventh item in the ACQ is the percent predicted FEV1. Each of the seven items is scored from from 0 (best) to 6 (worst), and then the seven items are averaged to yield a number from 0 (best) to 6 (worst). Asthma patients needed to display an ACQ greater than or equal to 1.25 in order to be eligible for randomization. A reduction of 0.5 units or more in the ACQ over the 16 weeks of treatment is considered to be clinically significant.|Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||units on a scale||Standard Error|Least Squares Mean
1274707|NCT00318656|Secondary|Glycaemia According to CGMS (MAGE), mg/dL|Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
1274708|NCT00318656|Secondary|Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
1274710|NCT00318656|Secondary|Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
1274711|NCT00318656|Secondary|Glycaemia According to CGMS (Dawn), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia “at dawn” measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
1274712|NCT00318656|Secondary|Glycaemia According to CGMS (Diurnal), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
1274713|NCT00318656|Secondary|Glycaemia According to CGMS (Nocturnal), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
1274714|NCT00318656|Secondary|8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate|8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal. The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.|Baseline and 12 weeks|ITT (randomized)|||pg/mL||Standard Error|Mean
1274715|NCT00318656|Secondary|HbA1c (Glycosylated Hemoglobin)|Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital|Baseline and 12 weeks|ITT (randomized)|||Percentage||Standard Error|Mean
1274716|NCT00318656|Secondary|Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Episodes||Standard Error|Mean
1274717|NCT00318656|Secondary|Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Hours||Standard Error|Mean
1274718|NCT00318656|Secondary|Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Episodes||Standard Error|Mean
1274719|NCT00318656|Secondary|Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Hours||Standard Error|Mean
1274720|NCT00318656|Secondary|Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Episodes||Standard Error|Mean
1274721|NCT00318656|Secondary|Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Hours||Standard Error|Mean
1274722|NCT00318656|Primary|Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Episodes||Standard Error|Mean
1274723|NCT00318656|Primary|Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized): This Intent-to-treat (ITT) population included all subjects who had been randomised, who had received at least one dose of study medication, and for whom at least one efficacy criteria on treatment period was available. The ITT population was the primary population for the efficacy analysis.|||Hours||Standard Error|Mean
1274724|NCT00318591|Secondary|Number of Participants With One or More Urinary Tract Infection||4-6 months||||participants|||Number
1274725|NCT00318591|Secondary|Device-related or Possibly Device-related AEs||4-6 months||||Events|||Number
1274726|NCT00318591|Secondary|Nurse Time Spent on Catheterization Procedure||4-6 months|ITT-population|||seconds||Standard Deviation|Mean
1274727|NCT00318591|Secondary|Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction|Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)|4-6 months|ITT population|||scores on a scale||Standard Deviation|Mean
1274728|NCT00318591|Secondary|Nurse Evaluation of Catheters - Overall Satisfaction|Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)|4-6 months|Analysis were done on evaluations of the ITT-population. Evaluations were made at discharge from hospital. Since some participants discontinued the study prior to discharge and since some did not fill in the evaluation form, the total number of evaluations (132) do not add up to the total of the ITT population (219)|||scores on a scale||Standard Deviation|Mean
1274729|NCT00318591|Secondary|UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml|UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis|4-6 months|Descriptive only|||UTI|||Number
1274730|NCT00318591|Primary|Occurrence of Symptomatic Urinary Tract Infections (UTIs)|Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI|4-6 months|ITT-population, symptomatic urinary tract infections treated with antibiotics|||participants|||Number
1274792|NCT00317941|Secondary|Percentage of Sites Developing a Severe Reaction 24 Hours After Injection|An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis|Up to 3 months assessed every 24 hours after each injection||||Percentage of sites|Participants||Number
1274731|NCT00318565|Primary|Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.|The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.|7 Days||||percentage of participants||95% Confidence Interval|Mean
1274732|NCT00318565|Primary|Percentage of Subjects With Complete Bidirectional Conduction Block.|Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.|During the procedure|"Per protocol analysis. Number differs from Participant Flow because only 253 subjects were considered for the efficacy cohort."|||percentage of participants||95% Confidence Interval|Mean
1274733|NCT00318474|Secondary|Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level||12 months|||||||
1274734|NCT00318474|Primary|Change in Proteinuria - Uprotein/Creatinine Ratio|Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.|Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.||||ratio||Standard Deviation|Mean
1274735|NCT00318461|Secondary|Hypoglycaemic Episodes at Week 104|Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-104|Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.|||episodes|||Number
1274736|NCT00318461|Secondary|Hypoglycaemic Episodes at Week 26|Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.|||episodes|||Number
1274737|NCT00318461|Secondary|Change in Beta-cell Function at Week 104|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)."|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point (%point)||Standard Error|Least Squares Mean
1274738|NCT00318461|Secondary|Change in Beta-cell Function at Week 26|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)."|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point (%point)||Standard Error|Least Squares Mean
1274739|NCT00318461|Secondary|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104|Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
1274740|NCT00318461|Secondary|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26|Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
1274741|NCT00318461|Secondary|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104|"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three."|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
1274742|NCT00318461|Primary|Change in Glycosylated A1c (HbA1c) at Week 104|Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
1274793|NCT00317941|Secondary|Percentage of Participants Without ISR Reported by Participants||Up to 3 months assessed every 24 hours after each injection||||Percentage of participants|||Number
1274743|NCT00318461|Secondary|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26|"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three."|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/l||Standard Error|Least Squares Mean
1274744|NCT00318461|Secondary|Change in Fasting Plasma Glucose (FPG) at Week 104|Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
1274745|NCT00318461|Secondary|Change in Fasting Plasma Glucose (FPG) at Week 26|Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
1274746|NCT00318461|Secondary|Change in Body Weight at Week 104|Change in body weight from baseline (week 0) to 104 weeks (end of treatment)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
1274747|NCT00318461|Secondary|Change in Body Weight at Week 26|Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
1274748|NCT00318461|Primary|Change in Glycosylated A1c (HbA1c) at Week 26|Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1274749|NCT00318409|Primary|Acceptability: Proportion of Participants Discontinuing Medication in Both Arms|Proportion of participants who discontinued study medication for at least one week prior to study completion.|12 weeks||||percentage of discontinuations|||Number
1274750|NCT00318409|Primary|Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report|Proportional of reported days taking study drug during the 12 weeks of study.|12 weeks||||percentage of self-reported adherence|||Number
1274751|NCT00318409|Primary|Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings|Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.|12 weeks||||percentage adherence by MEMS|||Number
1274752|NCT00318409|Primary|Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.||throughout study||||number of adverse events|||Number
1274753|NCT00318409|Primary|Feasibility: Participants Who Completed the Trial||12 weeks||||participants who completed the trial|||Number
1274754|NCT00318409|Primary|Feasibility: Proportion of Urine Samples Collected||12 weeks||||Urine samples collected|Participants||Number
1274755|NCT00318409|Primary|Feasibility: Proportion of Scheduled Study Visits Completed||12 weeks||||Scheduled study visits completed|Participants||Number
1274756|NCT00318409|Primary|Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled||At Enrollment||||Eligible persons screened who enrolled|||Number
1274757|NCT00318370|Secondary|Percentage of Participants Who Had a Prolongation of Remission|Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator’s assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.|Baseline to response (up to 44 months)|All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.|||percentage of participants||95% Confidence Interval|Number
1274758|NCT00318370|Secondary|Progression-free Survival (PFS)|PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 >2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.|Baseline to response (up to 44 months)|All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.|||Months||95% Confidence Interval|Median
1274759|NCT00318370|Secondary|Overall Response Rate|The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, “complete response” (CR), “partial response” (PR), “stable disease” (SD), or “progressive disease” (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR.|Baseline to response (up to 44 months)||||percentage of participants|||Number
1274760|NCT00318370|Secondary|Duration of Serologic Response (CA-125)|Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being >2 X ULN on two occasions.|Baseline to response (up to 44 months)|All participants enrolled to initial chemotherapy plus farletuzumab.|||Months||95% Confidence Interval|Median
1274794|NCT00317941|Secondary|Percentage of Injection Sites Per Participant With Reaction Reported by Physicians||Up to 3 months||||Percentage of ISR|Participants||Number
1274761|NCT00318370|Secondary|Time to Serologic Response (Change in CA-125 Level)|Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.|Baseline to response (up to 27 weeks)|All participants enrolled to intial chemotherapy plus farletuzumab.|||Weeks||95% Confidence Interval|Median
1274762|NCT00318370|Primary|Serologic Response (Change in Cancer Antigen [CA-125] Level)|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).|Baseline to response (up to 27 weeks)|All participants enrolled to chemotherapy plus farletuzumab.|||participants|||Number
1274763|NCT00318370|Primary|Serologic Response (Change in CA125 Level)|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).|Baseline to response (up to 30 weeks)|All participants enrolled to initial farletuzumab only.|||participants||95% Confidence Interval|Number
1274764|NCT00318292|Primary|Visual Analogue Scale (VAS) Pain Score|Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.|30 minutes post-op||||points on a scale||Standard Deviation|Mean
1274765|NCT00318149|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.|||Participants|||Count of Participants
1274766|NCT00318149|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 =event that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the study vaccination.|During the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.|||Participants|||Count of Participants
1274767|NCT00318149|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, joint pain, muscle aches and shivering. Any = occurrence of any general symptom regardless of intensity grade and relationship to vaccination. Grade 3 = symptoms that prevented normal activity. Grade 3 fever = fever >39°C. Related = general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.|||Participants|||Count of Participants
1274768|NCT00318149|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were haematoma, pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevented normal everyday activity. Grade 3 haematoma/redness/swelling = haematoma/redness/swelling spreading beyond 50 millimeters (mm).|During the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.|||Participants|||Count of Participants
1274769|NCT00318149|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 90 and Day 180|The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.|||Participants|||Count of Participants
1274770|NCT00318149|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 0 and at Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||Participants|||Count of Participants
1274771|NCT00318149|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 90 and Day 180|The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.|||Fold change||95% Confidence Interval|Geometric Mean
1274772|NCT00318149|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||Fold change||95% Confidence Interval|Geometric Mean
1274773|NCT00318149|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 90 and Day 180|The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.|||Participants|||Count of Participants
1274774|NCT00318149|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||Participants|||Count of Participants
1274775|NCT00318149|Secondary|Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease|"Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).~Seropositivity was defined as a serum HI titer of ≥ 1:10."|At Day 90 and Day 180|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.|||Titers||95% Confidence Interval|Geometric Mean
1274776|NCT00318149|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease|"Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).~Seropositivity was defined as a serum HI titer greater than or equal to (≥) 1:10."|At Day 0 and at Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||Titers||95% Confidence Interval|Geometric Mean
1274777|NCT00318149|Primary|Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers|The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||T-cells/million cells||Standard Deviation|Geometric Mean
1274778|NCT00318136|Secondary|Progression-free Survival|"Progression−free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab.~Summary of PFS (median) was estimated from Kaplan−Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley."|Length of study|Enrolled patients|||Months||95% Confidence Interval|Median
1274779|NCT00318136|Secondary|Adverse Events That Led to Discontinuation of Bevacizumab|Any treatment-emergent adverse event leading to study treatment discontinuation|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients|||Patients|||Number
1274780|NCT00318136|Secondary|Selected Adverse Events|"Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions.~Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting."|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients|||Patients|||Number
1274781|NCT00318136|Primary|Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events|"To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients|||Percentage of patients|||Number
1274782|NCT00317941|Secondary|Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants|"if the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction.~An injection site is seen as developing no reaction if the patient’s score for this site is of a reaction intensity = 0."|Up to 3 months assessed every 48 hours after each injection||||Percentage of sites|Participants||Number
1274783|NCT00317941|Secondary|Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants||Up to 3 months assessed every 24 hours after each injection||||Percentage of sites|Participants||Number
1274784|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|24h after injection||||Scores on a scale||Full Range|Mean
1274785|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|1h after injection||||Scores on a scale||Full Range|Mean
1274795|NCT00317941|Secondary|Percentage of Injection Sites With Pain Reported by Physicians||Up to 3 months||||Percentage of sites|Participants||Number
1274798|NCT00317941|Primary|Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection|An injection site is seen as developing a reaction if the patient’s score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed|Up to 3 months assessed every 48 hours after each injection||||Percentage of sites|Participants||Number
1274799|NCT00317941|Primary|Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection|An injection site is seen as developing a reaction if the patient’s score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed|Up to 3 months assessed every 24 hours after each injection||||Percentage of sites|Participants||Number
1274800|NCT00317720|Primary|Clinical Benefit Response Rate (CBR)|Efficacy measured by the clinical benefit response rate (CBR), defined as confirmed Complete Response (CR) plus Partial Response (PR) at any time plus Persistent Stable Disease (pSD). Confirmed CR is defined as disappearance of all target lesions at the time of radiographic evaluation; pSD was defined as SD lasting 24 weeks. Complete Response (CR): disappearance of all target lesions, and Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as a reference the baseline sum LD. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started.|6 weeks||||percentage of partcipants|||Number
1274801|NCT00317720|Primary|Optimal Dose of RAD001 in Combination With Trastuzumab (Phase I)|"In Phase I, two dose levels of RAD001 were studied: 10 mg (dose level 1) and 5 mg (dose level -1) where each dose was evaluated after cycle 1. At MDACC, the Continual Reassessment Method (CRM) for determining Maximum Tolerated Dose (MTD) was applied to the two predefined RAD001 dose levels; and at DFCI/BIDMC, a 3 x 3 study design was utilized.~Optimal dose defined as the dose most closely associated with a toxicity rate of 0.20, and toxicity defined as any grade 3 or 4 toxicity (based on Common Terminology Criteria (CTC) version 3.0 except fatigue. Participants underwent clinical evaluation every 3 weeks (one cycle) and radiologic evaluations every 6 weeks. After the second cycle, participants underwent a radiologic evaluation using the same imaging technique used at initial evaluation (ie, computed tomography or magnetic resonance imaging)."|Following two 3 week cycles of therapy|At MDACC, sixteen participants total treated at 10 mg (dose level 1) in the Phase I portion of the study with the remainder thirty-four registered in Phase II. At DFCI/BIDMC, the first three participants were included in the Phase I portion of the study, the remaining four of seven registered were in Phase II.|||mg|||Number
1274802|NCT00317642|Secondary|Participants With Adverse Events (CSR 7-April-11)|"Number of participants with treatment emergent adverse events (TEAEs) or death due to related AE. Related AEs for the combination arm can be related to either clofarabine or cytarabine.~Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life Threatening AE, Grade 5 = Death"|Day 1 up to a maximum of 4 years (includes up to a maximum of 3 cycles of therapy plus 45 days follow up. Related AEs are followed to resolution.)|Safety Set - Participants in the Full Analysis Set (FAS) who received at least 1 dose of study drug.|||participants|||Number
1274803|NCT00317642|Secondary|Four-Month Event-free Survival Per IRRP Assessment – Overall and by Randomized Strata (CSR 9-July-12)|"Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) to Day 122|Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, that is the strata include the IVRS mistakes.|||percentage of participants|||Number
1274804|NCT00317642|Secondary|Four-Month Event-free Survival Per IRRP Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) to Day 122|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.|||percentage of participants|||Number
1274805|NCT00317642|Secondary|Event-free Survival by IRRP Assessment – Overall and by Randomized Strata (CSR 9-July-12)|"Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) up to approximately 4 years|Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.|||months||95% Confidence Interval|Median
1274806|NCT00317642|Primary|Overall Survival - Overall and by Randomized Strata (CSR 9-July-12)|Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 randomized strata. OS was defined as the number of months from date of randomization until date of death due to any cause.|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS) - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.|||months||95% Confidence Interval|Median
1283007|NCT00234286|Secondary|Number of Individuals Who Died in Restraints|Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
1274807|NCT00317642|Secondary|Event-free Survival by IRRP Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.|||months||95% Confidence Interval|Median
1274808|NCT00317642|Secondary|Disease-free Survival by IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)|"Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first.~See Outcome #3 for definition of CR and CRi.~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.|||months||95% Confidence Interval|Median
1274809|NCT00317642|Secondary|Disease-free Survival by IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)|"Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first.~See Outcome #3 for definition of CR and CRi.~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.|||months||95% Confidence Interval|Median
1274810|NCT00317642|Secondary|Duration of Remission (DOR) Per IRRP Assessment-Overall and by Randomized Strata (CSR 9-July-12)|"DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy [including hematopoietic stem cell transplant] while in remission, or death due to any cause, whichever occurred first.~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.|||months||95% Confidence Interval|Median
1274811|NCT00317642|Secondary|Duration of Remission (DOR) Per IRRP Assessment-Overall and by Calculated Strata (CSR 7-April-11)|"DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy [including hematopoietic stem cell transplant] while in remission, or death due to any cause, whichever occurred first.~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.|||months||95% Confidence Interval|Median
1274812|NCT00317642|Secondary|Best Response Per Independent Response Review Panel (IRRP) Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Percentage of participants whose best response was assessed by the IRRP as complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) using the revised International Working Group for Response Criteria (Cheson 2003).~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 up to approximately 6 months|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.|||percentage of participants|||Number
1274813|NCT00317642|Primary|Overall Survival – Overall and by Calculated Strata (CSR 7-April-11)|Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 calculated strata. OS was defined as the number of months from date of randomization until date of death due to any cause.|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.|||months||95% Confidence Interval|Median
1274818|NCT00317239|Primary|Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL||anytime during the study|Modified Intent to Treat (mITT) population defined as subjects who received at least 1 dose of study medication, had stable EPO for at least 8 weeks prior to randomization, had at least 1 post-baseline hemoglobin assessment, and who had NDD-CKD characterized by a GFR ≤45 mL/min/1.73²|||participants|||Number
1274819|NCT00317226|Primary|Incidence of Treatment-emergent Adverse Events||44 week study duration||||each event|||Number
1274820|NCT00317109|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Months 15-18 and up to Months 25-31 post vaccination|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.|||Subjects|||Number
1274821|NCT00317109|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.|||Subjects|||Number
1274822|NCT00317109|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.|During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in.|||Subjects|||Number
1274823|NCT00317109|Secondary|Number of Subjects With Solicited Local Symtoms|Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.|During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine|The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in.|||Subjects|||Number
1274824|NCT00317109|Secondary|Number of Subjects With Fever|Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.|During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine|The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.|||Subjects|||Number
1274825|NCT00317109|Secondary|Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135|Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.|At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1274826|NCT00317109|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1274827|NCT00317109|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).|Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1274828|NCT00317109|Secondary|Anti-PSW Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1274829|NCT00317109|Secondary|Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody concentrations were ≥ 0.3 µg/mL.|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1274830|NCT00317109|Secondary|Anti-PSA and Anti-PSC Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1274831|NCT00317109|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values|Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1274832|NCT00317109|Secondary|Anti-rSBA-MenA, C, W-135 Antibody Titers|Antibody titers were expressed as geometric mean titers (GMTs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1274833|NCT00317109|Secondary|Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs|Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1274834|NCT00317109|Primary|Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies|Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.|At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1274835|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months||||Inhalations||Standard Error|Least Squares Mean
1274836|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months||||Scores on a scale||Standard Error|Least Squares Mean
1274837|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months||||Scores on a scale||Standard Error|Least Squares Mean
1274838|NCT00317044|Secondary|Number of Severe Adverse Events||Up to 6 months||||Events|||Number
1274839|NCT00317044|Secondary|Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7|The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5.|Randomization (Visit 3) to Visit 7||||Scores on a scale||Standard Error|Least Squares Mean
1274840|NCT00317044|Secondary|Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7|The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life).|From randomization (Visit 3) to Visit 7||||Scores on a scale||Standard Error|Least Squares Mean
1274841|NCT00317044|Secondary|Number of Patients With Severe Asthma Exacerbations.||Up to 6 months||||Participants|||Number
1274842|NCT00317044|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.|Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis.|From randomization (Visit 3) to visit 7.||||Liters||Standard Error|Least Squares Mean
1274843|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma|Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis.|Baseline to 6 months||||Percent of nights||Standard Error|Least Squares Mean
1274844|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months|This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period.|Baseline to 6 months||||Inhalations||Standard Error|Least Squares Mean
1274880|NCT00316719|Secondary|Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52|Participants with loss of Hepatitis B e antigen (HBeAg) and positive for anti-Hepatitis B e antibody (HBeAb) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBeAg and negative for HBeAb at baseline|||Percentage of participants|||Number
1274845|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total|Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores.|Baseline to 6 months||||Scores on a scale||Standard Error|Least Squares Mean
1274846|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))|Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available.|Baseline to 6 months||||L/minute||Standard Error|Least Squares Mean
1274847|NCT00317044|Primary|Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).|Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.|Baseline to 6 months||||L/minute||Standard Error|Least Squares Mean
1274848|NCT00316914|Secondary|Change From Baseline in Quality of Life (QOL) at One Month|Quality of Life (QOL) were measured using the Symptom Experience Diary and supplemental quality of life questions. Item score range: 0 (no symptom) to 10 (worst symptom). The score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.|Baseline and One month|Includes all patients with at least one assessment after baseline.|||Units on a scale||Standard Deviation|Mean
1274849|NCT00316914|Secondary|Change From Baseline in Fatigue Score at One Month|Fatigue was measured by Brief Fatigue Inventory in the scale of 0 (no fatigue) to 10 (fatigue as bad as you can imagine). The item score was reversed and transformed into 0 (low quality of life (QOL)) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.|Baseline and One month|Includes all patients with at least one assessment after baseline.|||units on a scale||Standard Deviation|Mean
1274850|NCT00316914|Secondary|Percentage of Patients Experiencing Impact on Activities of Daily Living (ADL)|Activities of daily living were measured using the Symptom Experience Diary and supplemental quality of life questions. The questionnaires' items were in the scale of 0 (no symptom) to 10 (worst symptom).|127 days|Data was collected but not analyzed for this outcome.||||||
1274851|NCT00316914|Secondary|Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event|Adverse Events were measured using CTCAE V3.0.|127 days|Analyses of adverse events includes all patients. Adverse event data is not available on one patient in Placebo arm, which leads to the total of 51 in Placebo arm for analysis.|||Percentage of Participants|||Number
1274852|NCT00316914|Secondary|Percentage of Patients With Acute Neuropathic Adverse Event|Acute neuropathic toxicities were measured using the Symptom Experience Diary and supplemental quality of life questions in the scale of 0 (no symptom) to 10 (worst symptom). The item score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Any score greater than 0 was considered having acute neuropathy.|127 days|Includes all patients that reported at least one value after baseline.|||Percentage of participants|||Number
1274853|NCT00316914|Secondary|Average Duration of Oxaliplatin-containing Treatment||127 days|Because of the early closure of this trial, no reliable data were available for this outcome.||||||
1274854|NCT00316914|Secondary|Average Cumulative Oxaliplatin Dose||127 days|Because of the early closure of this trial, no reliable data were available for this outcome.||||||
1274855|NCT00316914|Secondary|Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity|Neurotoxicity were assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.|||Percentage of Participants|||Number
1274856|NCT00316914|Secondary|Average Duration of Chronic Neuropathic Toxicity|Neuropathic adverse events were assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.|||days||95% Confidence Interval|Median
1274857|NCT00316914|Secondary|Time to Onset of Grade 3+ Chronic Neurotoxicity|Neurotoxicity was assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.|||Days||95% Confidence Interval|Median
1274858|NCT00316914|Secondary|Time to Onset of Grade 2+ Chronic Neurotoxicity|Neurotoxicity were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|127 days|Includes all patients that reported at least one value after baseline.|||Days||95% Confidence Interval|Median
1274859|NCT00316914|Primary|Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event|Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory losses that are disabling (Grade 4)|127 days|Efficacy analyses use all patients that reported at least one value after baseline.|||Percentage of participants|||Number
1274860|NCT00316888|Secondary|3-year Colostomy-free Survival Rate|Colostomy-free survival was defined as time from registration until time of colostomy or death without colostomy, censoring cases without colostomy at the data of last disease assessment documenting the patient was free of colostomy. Kaplan-Meier method was used to estimate the 3-year colostomy-free survival rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients who did not have permanent colostomy at study entry|||proportion of participants||95% Confidence Interval|Number
1274881|NCT00316719|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52|Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method|Week 52|PPS: participants who were positive for HBeAg at baseline|||percentage of participants|||Number
1274861|NCT00316888|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).|Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST|eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
1274862|NCT00316888|Secondary|3-year Progression-free Survival Rate|Progression-free survival (PFS) was defined as time from registration to disease progression, relapse or death (whichever occurred first), censoring cases without PFS events at the date of last disease assessment documenting the patient was free of progression/relapse. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the 3-year PFS rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
1274863|NCT00316888|Secondary|3-year Overall Survival Rate|Overall survival (OS) is defined as time from registration to death from any cause. Patients alive are censored at the last contact date. Kaplan-Meier method was used to estimate the 3-year OS rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
1274864|NCT00316888|Primary|Local Failure Rate at 3 Years|Local failure was defined as progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes after completion of protocol therapy, or progression during protocol therapy. Lost to follow-up and death (regardless of cause of death) prior to 3 years were also considered as local failures. For the calculation of local failure rate at 3 years, patients were classified into two groups (ie, coded as binary variable): failure (patients with local failure events prior to 3 years) vs. no failure (patients who still alive and had no local failure at 3 years). The binomial proportion and its exact two-sided 80% confidence interval (CI) were used to estimate it.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients|||proportion of participants||80% Confidence Interval|Number
1274865|NCT00316862|Secondary|Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity|Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, deemed as at least possibly related to treatment, graded using the NCI CTCAE version 3.0|Up to 5 years|1 participant was not evaluated for adverse events.|||percentage of participants|||Number
1274866|NCT00316862|Secondary|Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis|Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis, deemed at least possibly related to treatment graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 5 years|1 participant was not evaluated for adverse events.|||percentage of participants|||Number
1274867|NCT00316862|Secondary|Patterns of Failure||Up to 5 years|||||||
1274868|NCT00316862|Secondary|Overall Survival||Up to 5 years|||||||
1274869|NCT00316862|Secondary|Disease-free Survival||Up to 5 years|||||||
1274870|NCT00316862|Secondary|Utility of Early PET Imaging in Predicting Response to Treatment||Up to 55 days|||||||
1274871|NCT00316862|Primary|Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery|A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor|Up to 5 years|27 participants with adenocarcinoma were recruited and evaluated for the primary outcome per protocol design.|||percentage of participants||95% Confidence Interval|Number
1274872|NCT00316719|Secondary|Rate of Emergence of Resistant Virus at Week 52|Participants with resistant mutation at Week 52. LAM resistant mutation (enzyme-linked mini-sequencing assay): rtM204I/V; ADV resistant mutation (direct sequencing assay): rtN236T or rtA181T/V in HBV DNA ; rt: reverse transcriptase gene|Week 52|PPS|||Percentage of participants|||Number
1274873|NCT00316719|Secondary|Time to Onset of ALT Normalization|Time to onset of ALT normalization was summarized using the Kaplan-Meier method.|From Baseline to Week 52|PPS: Participants with abnormal ALT value (>ULN) at baseline|||Week 52||95% Confidence Interval|Median
1274874|NCT00316719|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52|ALT normalization was defined as an ALT value that was in the normal range (<= 45IU/L; upper limit of normal [ULN]) at Week 52 of the participants whose ALT values were abnormal (>45IU/L) at baseline|Week 52|PPS: Participants with an abnormal ALT value (>ULN) at baseline|||Percentage of participants|||Number
1274875|NCT00316719|Secondary|Mean Alanine Aminotransferase (ALT) Level at Week 52|Summary statistics were displayed for serum ALT.|Week 52|PPS|||Units per Liter||Standard Deviation|Mean
1274876|NCT00316719|Secondary|Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52|Participants with loss of Hepatitis B s antigen (HBsAg) and positive for anti-Hepatitis B s antibody (HBsAb) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBsAg and negative for HBsAb at baseline|||percentage of participants|||Number
1274877|NCT00316719|Secondary|Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52|Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBsAg at baseline|||percentage of participants|||Number
1274878|NCT00316719|Secondary|Time to Onset of HBeAg/Ab Seroconversion|Time to onset of HBeAg/Ab seroconversion in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.|From Baseline to Week 52|||||||
1274882|NCT00316719|Secondary|Time to Onset of HBV DNA Loss (< 400 Copies/mL)|Time to onset of an HBV DNA level in serum of less than 400 copies/mL was summarized using the Kaplan-Meier method. Regarding the Measured Values, the median time to onset and its upper limit for the ADV group and the upper limit of the median time to onset for the LAM group are non-estimable because they are not observed until the end of the study. The lower limit of the median time to onset for the ADV and LAM groups are 36.0 and 20.0, respectively. The median time to onset for the LAM group is 28.0|From Baseline to Week 52|||||||
1274883|NCT00316719|Secondary|Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52|The percentages of participants with an HBV DNA level in serum of less than 400 copies/mL, which is the lower limit of detection (HBV DNA loss) at Week 52|Week 52|PPS|||Percentage of participants|||Number
1274884|NCT00316719|Primary|Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52|Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52|Baseline and Week 52|Per Protocol Set (PPS): participants in the Full Analysis Set (all subjects who entered the study, received at least one dose of investigational product, and had at least one efficacy assessment after the treatment initiation) population with no major protocol violations|||log10 copies/mL||Standard Deviation|Mean
1274885|NCT00316706|Secondary|Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up|"Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes."|From Month 24 to Month 48|Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.|||Subjects|||Number
1274886|NCT00316706|Secondary|Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes."|From Month 18 to Month 24|Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point.|||Subjects|||Number
1274887|NCT00316706|Secondary|Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Month 36 and 48|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1274888|NCT00316706|Secondary|Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Months 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1274889|NCT00316706|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At 18, 24, 36 and 48 months|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on those subjects from the Cervarix Group with available data for the defined time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1274890|NCT00316693|Secondary|Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples|"Abnormalities in concentrations (expressed as milligrams per deciliter [mg/dL]) are presented categorical as follows:~Protein: <10 (-)*; 10-25 (+-)*; 25-85 (+); 85-250 (2+); 250-800 (3+).~Glucose: <30 (-)*; 30-60 (+-)*; 60-125 (+); 125-250 (2+); 250-750 (3+).~Urobilinogen: <1.5 (+-)*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+).~Bilirubin: <0.35 (-)*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+).~Occult blood: <0.015 (-)*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); >0.75 (3+).~Ketone body: <2.5 (-)*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+).~Normal ranges indicated by asterix*."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
1274891|NCT00316693|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters|"Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined.~Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH)."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
1274892|NCT00316693|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters|"Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count.~Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
1274893|NCT00316693|Secondary|Outcome of Any Reported Pregnancies|Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.|Throughout the study period (up to Month 24)|Analysis was performed on those subjects reporting pregnancy during the study period.|||Participants|||Count of Participants
1275123|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 4)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|4 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
1274894|NCT00316693|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (up to Month 24)|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
1274895|NCT00316693|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 24)|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
1274896|NCT00316693|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days after any vaccination|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
1274897|NCT00316693|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.|Within 7 days after each and any vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
1274898|NCT00316693|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Months 0, 6, 7, 12, 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1274899|NCT00316693|Secondary|Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value|Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL.|At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.|||Participants|||Count of Participants
1274900|NCT00316693|Secondary|Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type|"Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
1274901|NCT00316693|Secondary|Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type|"Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
1274902|NCT00316693|Secondary|Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types|"Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6].~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
1274903|NCT00316693|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types|"Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
1274904|NCT00316693|Secondary|Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection|Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
1274922|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Any Time|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|At any time|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274905|NCT00316693|Secondary|Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection|Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
1274906|NCT00316693|Secondary|Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)|HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
1274907|NCT00316693|Primary|Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)|Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6].|Throughout the study period (up to Month 24)|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
1274908|NCT00316355|Primary|Treatment-related Total Cost Estimates|total estimated costs calculated based upon the fixed-dose schedule|Posttreatment|Treatment completers|||dollars||Standard Deviation|Mean
1274909|NCT00316355|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score|The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.|Pretreatment, Posttreatment, and 3-month follow-up|Randomized participants|||units on a scale||Standard Deviation|Mean
1274910|NCT00316303|Primary|Referral for Medical Care|For participants infected with hepatitis C, their self-report of being referred for medical care.|6 Months||||participants|||Number
1274911|NCT00316303|Primary|Tested for HIV|Participant self-report of being tested for HIV|6 Months||||participants|||Number
1274912|NCT00316303|Primary|Tested for Hepatitis B|Participant self-report of being tested for hepatitis B|6 Months||||participants|||Number
1274913|NCT00316303|Primary|Tested for Hepatitis C|Participant self-report of being tested for hepatitis C|6 Months||||participants|||Number
1274914|NCT00316303|Primary|Change in Immunization Status|Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.|Measured at 6 Months relative to Baseline||||participants|||Number
1274915|NCT00316277|Primary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment|In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence.|12 weeks in Phase 2 period (i.e., 24 weeks into the study)|360 participants randomized to Phase 2 were included in the analysis.|||participants|||Number
1274916|NCT00316277|Secondary|The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2|As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.|12 weeks||||participants|||Number
1274917|NCT00316277|Secondary|The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1|As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.|12 weeks|Participants randomized to Phase 1 were stratified by two variables: current chronic pain and lifetime heroin use.|||participants|||Number
1274918|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition|"As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."|12 weeks||||participants|||Number
1274919|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition|"As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."|12 weeks|379 identified as having chronic pain at baseline in Phase 1.|||participants|||Number
1274920|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up|A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks.|24 weeks in Phase 2 period (i.e., 36 weeks into the study)|360 participants randomized to Phase 2 were included in the analysis.|||participants|||Number
1274921|NCT00316277|Primary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1|In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks.|12 weeks|653 study participants randomized to Phase 1 were included in analysis.|||participants|||Number
1274923|NCT00316264|Secondary|The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|120 - 150 days post final pose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274924|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 150|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274925|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 60|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274926|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 0|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274927|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Any Time|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|At any time|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274928|NCT00316264|Secondary|The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|120 - 150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274929|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 150|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274930|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 60|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274931|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 0|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
1274932|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose||120-150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
1274933|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at Day 150||Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
1274934|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at Day 60||Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
1274935|NCT00316264|Secondary|The Serum Concentrations of Palivizumab at Day 0||Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
1274936|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose||120-150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
1274937|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab at Day 150||Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
1274938|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab at Day 60||Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
1274939|NCT00316264|Secondary|The Serum Concentrations of Motavizumab at Day 0||Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
1274940|NCT00316264|Primary|Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.|Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.|Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.|||participants|||Number
1274941|NCT00316264|Primary|Number of Subjects Reporting Adverse Events (AEs)||Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.|||participants|||Number
1274942|NCT00316264|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)||Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.|||participants|||Number
1274943|NCT00316225|Primary|Overview of Adverse Events|Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|baseline, up to 18 weeks|Patients who received at least one dose of study drug.|||participants|||Number
1274944|NCT00316225|Secondary|Discontinuations Due to Adverse Events|Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.|baseline, up to 18 weeks|Patients who received at least one dose of study drug.|||participants|||Number
1274945|NCT00316225|Other Pre-specified|Overall Tumor Response|"Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments.~CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions.~PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions.~SD (stable disease) = small changes that do not meet above criteria."|baseline, up to 18 weeks|Patients who received at least one dose of study drug.|||participants|||Number
1274946|NCT00316225|Secondary|Pemetrexed Population Pharmacokinetics: Volume of Distribution|Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.|Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion|Patients who received at least one dose of study drug.|||Liters (L)||Standard Deviation|Mean
1274947|NCT00316225|Secondary|Pemetrexed Population Pharmacokinetics (PK): Clearance|Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.|Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion|Patients who received at least one dose of study drug.|||milliliter per minute (mL/min)||Standard Deviation|Mean
1274948|NCT00316225|Secondary|Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities|"Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening.~NOS = Not otherwise specified."|baseline, up to 18 weeks|Patients who received at least one dose of study drug.|||participants|||Number
1274949|NCT00316199|Secondary|Overall Survival Probability|Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability.|baseline to date of death from any cause|All enrolled participants. Fifty-two participants were censored.|||percent|||Number
1283008|NCT00234286|Secondary|Individuals With an Intravenous Line|Presence of intravenous line infusing at time of death based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
1274950|NCT00316199|Secondary|Duration of Response|Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival.|time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|Enrolled participants who were considered responders (had either a complete response or partial response).|||months||95% Confidence Interval|Median
1274951|NCT00316199|Secondary|Progression-Free Survival|Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints.|baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants. Forty-two participants were censored.|||months||95% Confidence Interval|Median
1274952|NCT00316199|Secondary|Time to Treatment Failure|Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started.|baseline to stopping treatment|All enrolled participants. Time to treatment failure for participants who are still participating in the study without treatment failure at the time of analysis will be treated as censored at thte date of the last tumor assessment (3 participants censored).|||months||95% Confidence Interval|Median
1274953|NCT00316199|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants diagnosed with metastatic breast cancer, had measurable disease at baseline, and received at least one dose of study drug. Two participants were excluded from analysis because they received chemotherapy for locally advanced/metastatic breast cancer within 6 months prior to enrollment.|||participants|||Number
1274954|NCT00316186|Secondary|Grade 4 (Life-threatening or Disabling) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT population (i.e., participants who had at least one dose of study medication)|||participants|||Number
1274955|NCT00316186|Secondary|Grade 3 (Severe) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT population (i.e., participants who had at least one dose of study medication)|||participants|||Number
1274956|NCT00316186|Secondary|Grade 2 (Moderate) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT Population (i.e., participants who had at least one dose of study medication)|||participants|||Number
1274957|NCT00316186|Secondary|Grade 1 (Mild) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity)|ITT Population (i.e., participants who had at least one dose of study medication)|||participants|||Number
1274958|NCT00316186|Secondary|Overall Survival, Calculated as the Number of Subjects Who Died From the Start of Treatment Until Follow-up|Overall survival is defined as the time from the start of treatment until death due to any cause. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage of the study was not conducted.|Week 1 up to maximum of Day 519|||||||
1274959|NCT00316186|Secondary|Time to Progression|Time to progression is defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, if sooner. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.|From start of treatment to disease progression/death|||||||
1274960|NCT00316186|Secondary|Response Duration|Duration of response is calculated as the time from first documented partial or complete response until first documented sign of disease progression or death. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.|From time of partial or complete response to disease progression/death|||||||
1274992|NCT00316017|Secondary|Total Fluids First 24 Hours|The total amount of IV fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of 911 call|First 24 hours from the time of of 911 call||||Liters||Standard Deviation|Mean
1274961|NCT00316186|Secondary|Time to Response|Time to response is calculated as the time from the start of treatment until first documented evidence of partial or complete response. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage was not done.|From start of treatment to evidence of partial or complete response|||||||
1274962|NCT00316186|Primary|Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response|The categories of tumor response were: complete response (complete disappearance of all known lesions determined by 2 measurements not less than 4 weeks apart), partial response (>50% decrease in measurable lesions for at least 4 weeks with no appearance of new lesions), stable disease (no change in tumor size for at least 8 weeks), progressive disease (>25% increase in measurements of lesions or appearance of new lesions), and not evaluable. The overall response rate was determined using a scan performed within the first 30 days of the first response.|Baseline until up to Day 169|ITT (Intent to Treat): participants that received at least one dose of study drug|||Participants|||Number
1274963|NCT00316173|Secondary|Time to Disease Progression|"Although “Time to Disease Progression” was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of “Progression-free Survival”. As such, “Progression-free Survival” was measured, not “Time to Disease Progression”. See the outcome measure entitled Progression-free Survival for data pertaining to time to disease progression."|From start of treatment to disease progression/death|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||||||
1274964|NCT00316173|Secondary|The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)|CA-125 is a “tumor marker”, found in greater concentration in tumor cells than other cells of the body. Participants were classed as responders if their CA-125 level at the end of study was 50% or less of baseline. In addition, a confirmatory sample (taken at least 28 days after the first sample) must have also been 50% or less of baseline.|Baseline to end of study (up to 54.7 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||participants|||Number
1274965|NCT00316173|Secondary|Number of Participants Who Died From the Start of Treatment to Follow-up|"The number of participants who died from the start of treatment to follow-up was calculated. For participants who did not die, the date of last contact was used. The word used for such participants was censored."|From start of treatment to death (up to 110.4 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||participants|||Number
1274966|NCT00316173|Secondary|Progression-free Survival|"Progression-free survival (PFS) was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored. Although “Time to Disease Progression” was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of “PFS”. As such, “PFS” was measured, not “Time to Disease Progression”."|From start of treatment to disease progression/death (up to 67.7 weeks)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||weeks||95% Confidence Interval|Median
1274967|NCT00316173|Primary|Number of Participants With the Indicated Response|Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization [WHO] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: >50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: >25% increase in measurements of lesions or appearance of new lesions).|From start of treatment to evidence of CR or PR (up to 39.3 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||participants|||Number
1274968|NCT00316173|Secondary|Duration of Response|"Duration of response was calculated as the time from first documented PR or CR until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored."|From time of PR or CR to disease progression/death (up to 56.0 weeks)|All participants who showed a tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
1274969|NCT00316173|Secondary|Time to Response|Time to response was calculated as the time from start of treatment until first evidence of partial response (PR; >50% decrease in the measurements of the largest lesions with no appearance of new lesions) or complete response (CR; complete disappearance of all lesions).|From start of treatment to evidence of PR or CR (up to 39.3 weeks)|All participants who showed a tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
1274970|NCT00316121|Primary|Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)|Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).|24 months|Safety Population:All subjects treated. Full Analysis Set(FAS):Subset of Safety Pop. w/follow up. All effectiveness measures were to be assessed on FAS. FAS is intent-to-treat pop. Per Protocol: Subset of FAS who complete study, treated as randomized w/no major protocol deviations. All analyses were to be on this subset.|||Subjects|||Number
1274971|NCT00316082|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
1283009|NCT00234286|Secondary|Individuals With a Nasogastric Tube|Presence of nasogastric tube based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
1274972|NCT00316082|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
1274973|NCT00316082|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
1274974|NCT00316082|Secondary|Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||percent||Standard Error|Mean
1274975|NCT00316082|Primary|Change From Baseline in Hemoglobin A1 (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.|||percent||Standard Error|Mean
1274976|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received greater than 10 units of packed red blood cells (PRBC).|From the time dispatch received the 911 call to 28 days||||participants|||Number
1274977|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received greater than 10 units of packed red blood cells (PRBC).|The first 6 hours from the time of admission to the hospital||||participants|||Number
1274978|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died in Field or ED|This is the total number of subjects who died in the field or the ED among the patients who received greater than 10 units of packed red blood cells (PRBC).|From the time dispatch received 911 call to the time of death in the field or ED||||participants|||Number
1274979|NCT00316017|Secondary|Greater Than 10 Units PRBC in First 24 Hours|This is the total number of subjects who received greater than 10 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours||||participants|||Number
1274980|NCT00316017|Secondary|1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received 1 to 9 units of packed red blood cells (PRBC).|From the time dispatch received the 911 call to 28 days||||participants|||Number
1274981|NCT00316017|Secondary|1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received 1 to 9 units of packed red blood cells (PRBC).|The first 6 hours from the time of admission to the hospital||||participants|||Number
1274982|NCT00316017|Secondary|1-9 Units PRBC and Died in Field or ED|This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) among the patients who died in the field or the ED.|From the time dispatch received 911 call to the time of death in the field or ED||||participants|||Number
1274983|NCT00316017|Secondary|1-9 Units PRBC in First 24 Hours|This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours||||participants|||Number
1274984|NCT00316017|Secondary|Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received no units of PRBC.|From the time dispatch received the 911 call to 28 days||||participants|||Number
1274985|NCT00316017|Secondary|Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received no blood products.|The first 6 hours from the time of admission to the hospital||||participants|||Number
1274986|NCT00316017|Secondary|Zero Units PRBC and Died in Field or Emergency Department (ED)|This is the total number of subjects who died in the field or the ED from the set of subjects who received no blood products.|From the time dispatch received 911 call to the time of death in the field or ED||||participants|||Number
1274987|NCT00316017|Secondary|Zero Units PRBC in First 24 Hours|This is the total number of subjects who received no blood products in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours||||participants|||Number
1274988|NCT00316017|Secondary|Survival at Hospital Discharge|Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities.|Duration of hospital stay through to discharge||||participants|||Number
1274989|NCT00316017|Secondary|Days Alive Out of the Hospital Through Day 28|The number of days the patient is alive and no longer an inpatient in the hospital through day 28|First 28 days from the time of 911 call||||days||Standard Deviation|Mean
1274990|NCT00316017|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|The number of days the patient is alive and not being cared for in the intensive care unit|First 28 days from the time of 911 call||||days||Standard Deviation|Mean
1274991|NCT00316017|Secondary|Ventilator-free Days Through Day 28|"The number of days beginning with the day of 911 call counted as Day O through day 28 that the patient did not require mechanical ventilation"|Duration of hospital stay through day 28||||days||Standard Deviation|Mean
1274995|NCT00316017|Secondary|Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28|"Multiple Organ Dysfunction Score is described as:~Six organ systems were chosen, and a score of 0-4 allotted for each organ according to function (0 being normal function through to 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) in each 24-hour period is taken for calculation of the aggregate score."|28 days from time of ED arrival||||Scores on a scale||Standard Deviation|Mean
1274996|NCT00316017|Secondary|Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28|Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28|28 days from time of ED arrival||||participants|||Number
1274997|NCT00316017|Primary|28 Day Survival|"The day of episode is counted as Day 0. So for measures using a 28 day period, the maximum value is 29 (i.e. days 0 through 28)."|28 days from time of Emergency Department (ED) arrival|Per protocol, analysis was done on only those subjects who received the study fluid per randomization; this was defined as that the study fluid had been connected to the patient's IV.|||participants|||Number
1274998|NCT00316004|Secondary|Discharge Disposition|Disposition of patient at the time of discharge from the acute care hospital|Duration of hospital stay|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Participants|||Number
1274999|NCT00316004|Secondary|Packed Red Blood Cells (PRBC) First 24 Hours|The average (mean) number of units of packed red blood cells (PRBC) transfused in the first 24 hours following the time of the 911 call in each group.|First 24 hours from the time dispatch received 911 call|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.|||Unit of PRBC||Standard Deviation|Mean
1275000|NCT00316004|Secondary|Total Fluids in First 24 Hours|The average (mean) total amount of intravenous (IV) fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of the 911 call|First 24 hours from the time dispatch received 911 call|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.|||Liters||Standard Deviation|Mean
1275001|NCT00316004|Secondary|Presence of Nosocomial Infections|Includes one or more nosocomial infections diagnosed during the hospital stay but not present on admission to the hospital from the following list: pneumonia, bloodstream infection, urinary tract infection, and/or wound infection|From day of injury to 28 days after injury|"An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. Percentages were based on population at risk.~Row 1 nosocomial infections; Row 2 pneumonia; Row 3 bloodstream infections; Row 4 urinary tract infections; and Row 5 wound infections"|||Diagnoses|||Number
1275002|NCT00316004|Secondary|Days Alive Out of the Hospital Through Day 28|The number of days the patient is alive and no longer an inpatient in the hospital through day 28|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Days||Standard Deviation|Mean
1275003|NCT00316004|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|The number of days the patient is alive and not being cared for in the intensive care unit|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Days||Standard Deviation|Mean
1275004|NCT00316004|Secondary|Ventilator-free Days Through Day 28|"The number of days beginning with the day of 911 call counted as Day 0 through day 28 that the patient did not require mechanical ventilation. Deaths are assigned the worst score (0)."|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Days||Standard Deviation|Mean
1275005|NCT00316004|Secondary|Worst Multiple Organ Dysfunction Score (MODS) Through Day 28|Multiple Organ Dysfunction Score is described as: Six organ systems were chosen: 1) respiratory; 2) renal; 3) hepatic; 4) cardiovascular; 5) hematologic; and 6) neurologica. A score of 0-4 was allotted for each organ according to function (0 being normal function through 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) was taken for calculation of the aggregate score. Deaths are assigned the worst score (24).|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Scores on a scale||Standard Deviation|Mean
1275006|NCT00316004|Secondary|Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28|The patient is alive and free of ARDS from the date of injury through to the 28th day following injury. The diagnosis of ARDS is based on standard criteria: a) hypoxia with a ratio of arterial oxygen pressure to percent oxygen delivered of less than 200; b) bilateral infiltrates on chest X-ray; and c) clinical evidence of increased left atrial pressure or pulmonary artery wedge pressure of greater than 18 mmHg.|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Participants|||Number
1275007|NCT00316004|Secondary|Survival at Hospital Discharge up to 6 Months From Date of Injury|The patient who is admitted to the hospital alive after injury and is alive when discharged from the hospital up to 6 months from the date of injury.|Date of hospital discharge up to 6 months from date of injury|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.|||Participants|||Number
1275008|NCT00316004|Secondary|28 Day Survival|The patient who is admitted to the hospital after injury and is alive on the 28th day after injury. For 28-day survival, patients with missing 28-day vital status who were known to be discharged alive prior to 28 days were assumed to be alive at day 28.|28 days after injury|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who did not refuse or were lost to follow-up prior to discharge.|||Participants|||Number
1275009|NCT00316004|Secondary|Disability Rating Score (DRS) Categories of Disability|The DRS is an additional measure of neurological outcome that categorizes the patient's level of disability on a scale of 0 to 29, with 0 indicating no disability to 29 indicating extreme vegetative state. To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|6 months after injury|To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|||Participants (with imputed values)|||Number
1275010|NCT00316004|Secondary|Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥2, which is a diagnostic indicator of moderate to lethal head injury. Of this subset of participants with AIS≥2, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|||Participants (with imputed values)|||Number
1275011|NCT00316004|Primary|Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|||Participants (with imputed values)|||Number
1275012|NCT00316004|Secondary|Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥4, which is a diagnostic indicator of severe to lethal head injury. Of this subset of participants with AIS≥4, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|||Participants (with imputed values)|||Number
1275013|NCT00316004|Primary|Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis|Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE completed at 6 months after injury.|6 months after injury|The primary analysis was designed as modified intent-to-treat, with all patients who had fluid connected to intravenous (IV) tubing included regardless of how much fluid was administered. Per the a priori trial design, patients for whom the fluid bag was opened but not connected to the IV were not considered enrolled in the trial.|||Participants|||Number
1275014|NCT00315939|Primary|Frequency of Severe Hypoglycemia|"Severe hypoglycemia (SH) was defined to subjects as blood glucose so low that you could not treat yourself because you were stuporous or unconscious."|1 year (each level lasted 3 months)|"All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using dropout as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown."|||episodes/month/person|||Number
1275015|NCT00315939|Primary|Hemoglobin A1c||1 year (each level lasted 3 months)|All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using “dropout” as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.|||percentage of glycated hemoglobin||Standard Deviation|Mean
1275016|NCT00315822|Primary|Proportion of Patients With Collapsed Composite Complications|Proportion of patients with the collapsed composite complications, including surgical wound infection, anastomotic leak, intra-abdominal abscess, peritonitis without leak, sepsis, wound dehiscence, intestinal obstruction, bleeding, and death during 60 days after surgery|60 days after surgery||||Participants|||Count of Participants
1275018|NCT00315731|Secondary|Progression-free Survival|Progression-free survival, or time to progression, is defined as the time from the dosimetric dose to the first documented disease progression (PD) or death. PD is defined as a >= 50% increase from nadir in the SPPD for all measurable disease.|Week 7 to Week 260 post treatment|ITT-E Population|||months||95% Confidence Interval|Median
1275019|NCT00315731|Secondary|Duration of Response|Duration of response is defined as the time from first documented response (CR, CRu, or PR) until disease progression.|Week 7 to Week 260 post treatment|ITT-E Population. Only participants who had a response (CR, CRu, or PR) were evaluated.|||months||95% Confidence Interval|Median
1275020|NCT00315731|Secondary|Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)|Evaluation based on the Int'l Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma (NHL). CR, complete disappearance of all detectable clinical/radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to NHL. CRu, complete response unconfirmed, included complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. PR, >=50% decrease in sum of perpendicular diameters (SPD) of all measurable lesions determined at baseline. SD, less than a PR but not progressive disease (>=50% increase from nadir in SPD for all measurable disease or the appearance of any new lesion that was >=1.4 cm x 1.4 cm by radiographic evaluation or >=1.0 cm by palpation per physical examination).|From Baseline up to 99 Months|ITT-E Population. The individual categories for confirmed CR, confirmed CRu, etc. counts those participants who had their response confirmed by the exact same response, not those who had their response confirmed by a better response (for example, Cru to CR; PR to CR; PR to CRU; etc.).|||percentage of participants|||Number
1275021|NCT00315731|Secondary|Number of Participants With Expected Distribution of Radioactivity in the Circulatory System Compared With Uptake by Other Organs.|Expected biodistribution (images): most radioactivity (RA) in blood pool, with uptake in normal liver and spleen less than the heart. Later time points, RA in blood pool decrease and uptake in normal liver and spleen decrease. Images may show uptake by the thyroid gland, kidneys, urinary bladder, and lungs. Altered biodistribution: Blood pool not visualized or diffuse, intense uptake in the liver and/or spleen, or uptake suggestive of urinary obstruction, diffuse lung uptake greater than the blood pool|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points.|||participants|||Number
1275022|NCT00315731|Secondary|Mean Absorbed Dose in the Source Organs and the Target Organs|The radiation absorbed dose to source organs were determined with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software using residence times directly determined by an independent reviewer for kidneys, liver, lungs, spleen, urinary bladder, and total body; the radiation absorbed dose for the remaining target organs was based on a mathematical model used to calculate source organ radiation dose estimates using the same OLINDA/EXM software. OLINDA/EXM is a registered proprietary computer program.|0 to 7 days from dosimetric dose|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).|||mGy/MBq||95% Confidence Interval|Mean
1275023|NCT00315731|Secondary|Mean Residence Times From Day 0 to Day 7|Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. Assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the total body residence times. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).|||hours||95% Confidence Interval|Mean
1275024|NCT00315731|Secondary|Maximum Concentration (Cmax) Values|Maximum observed concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after the dose.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID/mL||95% Confidence Interval|Geometric Mean
1275025|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to Infinity (Extrapolated)|Ratio and 90% CI for AUC (0 to infinity) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose is given.|0 to infinity h from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID.h/mL||95% Confidence Interval|Geometric Mean
1275026|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to 168 Hours|Ratio and 90% confidence interval for AUC(0-168) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium-derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose.|0-168 h from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID.h/mL||95% Confidence Interval|Geometric Mean
1275027|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to 120 Hours|Area under the concentration-time curve from time 0 to 120 hours after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.|0-120 hours from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID.h/mL||95% Confidence Interval|Geometric Mean
1275028|NCT00315731|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.|0 to 7 days from dosimetric dose given only once on Day 0|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||milliliters (ml)||95% Confidence Interval|Geometric Mean
1275029|NCT00315731|Primary|Clearance (CL) Values|Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.|0 to 7 days from dosimetric dose given only once on Day 0|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||milliliters per hour (ml/hr)||95% Confidence Interval|Geometric Mean
1275030|NCT00315731|Primary|Terminal Phase Half-life (t½)|The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||hours||95% Confidence Interval|Geometric Mean
1275031|NCT00315731|Primary|Maximum Concentration (Cmax) Values|Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID/mL||95% Confidence Interval|Geometric Mean
1275032|NCT00315731|Primary|Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours|Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.|0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID.h/mL||95% Confidence Interval|Geometric Mean
1275033|NCT00315705|Secondary|Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 2|Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|All phase 2 participants. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
1275034|NCT00315705|Secondary|Number of Participants With 4-month Event Free Survival in Phase 2|Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.|4 months (Phase 2 portion of study)|All participants|||participants|||Number
1275035|NCT00315705|Secondary|Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 2|Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|All phase 2 participants. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
1275036|NCT00315705|Secondary|Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 2|Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|Phase 2 participants who achieved overall remission. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
1275037|NCT00315705|Secondary|Time to Remission for Participants Who Had a Response in Phase 2|The weeks between start of intervention and remission as assessed by the investigator in Phase 2. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.|up to 8 weeks (Phase 2 portion of study)|Participants in phase 2 who had an overall remission.|||weeks||Standard Deviation|Mean
1275038|NCT00315705|Secondary|Summary of Participants With Adverse Events (AEs) in Phase 2|Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is: > Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE|Up to 9.5 months (Phase 2 portion of study)|All phase 2 participants|||participants|||Number
1275039|NCT00315705|Primary|Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2|Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ≥75/ ≥0.75 [x 10^9/L] 2) CR in absence of plt recovery (CRp): plt ≥20 to <75 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.|Approximately 28-56 days (Phase 2 portion of study)|All phase 2 participants|||percentage of total participants|||Number
1275040|NCT00315705|Secondary|Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 1|Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|All phase 1 participants|||weeks||95% Confidence Interval|Median
1275041|NCT00315705|Secondary|Number of Participants With 4-month Event Free Survival in Phase 1|Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.|4 months (Phase I portion of study)|All participants|||participants|||Number
1275124|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|12 Weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
1275125|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|8 Weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
1275042|NCT00315705|Secondary|Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 1|Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|All phase 1 participants. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
1275043|NCT00315705|Secondary|Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 1|Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|Phase 1 participants who achieved overall remission. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
1275044|NCT00315705|Secondary|Time to Remission for Participants Who Had a Response in Phase 1|The weeks between start of intervention and remission as assessed by the investigator in Phase 1. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.|up to 8 weeks (Phase 1 portion of study)|Participants in phase 1 who had an overall remission.|||weeks||Standard Deviation|Mean
1275045|NCT00315705|Secondary|Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1|Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ALL ≥75/ ≥0.75 [x 10^9/L]; AML ≥100/ ≥1.0 [x 10^9/L] 2) CR in absence of plt recovery (CRp): ALL plt ≥20 to <75 x 10^9/L; AML plt ≥20 to <100 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.|Approximately 2 months (Phase 1 portion of study)|All phase 1 participants|||percentage of total participants|||Number
1275046|NCT00315705|Secondary|Summary of Participants With Adverse Events (AEs) in Phase 1|Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is: > Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE|Up to 9.5 months (Phase 1 portion of study)|All phase 1 participants|||participants|||Number
1275047|NCT00315705|Primary|Participants With Dose Limiting Toxicity in Phase 1|The number of participants in each cohort that had dose limiting toxicity is summarized. Toxicities were reviewed by an independent Data Safety Monitoring Board (DSMB) who determined if additional participants should be added to the cohort and the criteria for escalating to the next cohort.|Up to Day 42 (Phase 1 portion of study)|All phase 1 participants|||participants|||Number
1275048|NCT00315705|Primary|Maximum Tolerated Dose (MTD) in Phase 1|"The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused <= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 as taken by Cohort 5 was to become the RP2D.~The rating scale used is 0 = not the MTD, 1 = the MTD."|Up to Day 42 (Phase 1 portion of study)|All phase 1 participants|||units on a scale|||Number
1275049|NCT00315627|Secondary|Restoration of Hypoglycemia Awareness 1 Year After Transplantation|The number of subjects with restoration of hypoglycemia awareness 1 year after islet transplantation|1 year||||Participants|||Count of Participants
1275050|NCT00315627|Secondary|Elimination of Severe Hypoglycemia|The number of subjects with severe hypoglycemia after transplantation|1 year||||Participants|||Count of Participants
1275051|NCT00315627|Secondary|Improvement in Metabolic Control as Evidenced by Hemoglobin A1c < 6.5%|Number of subjects with a hemoglobin A1c < 6.5% at 1year after islet transplantation|1 year||||Participants|||Count of Participants
1275052|NCT00315627|Secondary|Islet Allograft Function|Number of subjects with basal C-peptide greater than 0.5 ng/ml|1 year||||Participants|||Count of Participants
1275053|NCT00315627|Primary|Measurement of Glycemic Control by HbA1c and Prevention of Severe Hypoglycemia|Number of subjects at 1 year with HbA1c < 6.5% and absence of severe hypoglycemia|1 year||||participants|||Number
1275054|NCT00315614|Secondary|Number of Subjects With Reduction of Severe Hypoglycemia and Improvement in Hypoglycemia Awareness|Number of subjects with reduction of episodes of severe hypoglycemia and the presence of awareness of hypoglycemia|for the duration of islet graft function||||Participants|||Count of Participants
1275055|NCT00315614|Secondary|Number of Subjects With Basal C-peptide Greater Than 0.5 ng/ml|Number of subjects with basal C-peptide greater than 0.5 ng/ml prior to weaning of immunosuppression;|for the duration of islet graft function||||Participants|||Count of Participants
1275056|NCT00315614|Primary|A Reduction or Absence of Rejection Episodes|Number of rejection episodes after transplantation. Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.|for the duration of islet graft function|IImmunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint. No data available to analyze.||||||
1275057|NCT00315614|Primary|The Achievement of Persistent Islet Function Following Cessation of Immunosuppression.|Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.|for the duration of islet graft function|IImmunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint. No data available to analyze.||||||
1275062|NCT00315458|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.|483 days|The full analysis population consisted of all subjects who were randomized into the double-blind phase and received at least 1 dose of double-blind treatment.|||participants|||Number
1275063|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.”~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)."|Baseline to day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
1275064|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)."|Baseline to day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
1275065|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.”~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
1275066|NCT00315445|Post-Hoc|"Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
1275067|NCT00315445|Post-Hoc|Sensitivity Analysis: “Pain Right Now” Change From Baseline in the Maintenance Period (Days 21–84), BOCF|Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.” Primary back pain was measured.|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
1275068|NCT00315445|Post-Hoc|Sensitivity Analysis: “Pain on the Average” Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)|Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.|Baseline to days 21 - 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
1275069|NCT00315445|Secondary|The Time to Discontinuation Due to Lack of Efficacy|Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure.|Time after dosing to dropout due to lack of efficacy|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn because the informed consent was never obtained and had no efficacy data."|||Days||Inter-Quartile Range|Median
1283010|NCT00234286|Secondary|Number of Patients Who Died in ICU|Location of death (ICU vs. other) based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
1275070|NCT00315445|Secondary|Time to Stable Pain Management|"For each subject, time to stable pain management is defined as the first (post-baseline) time during the titration period when his/her diary pain was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the pain on the average (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline)."|Start of study to day 21.|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Days||Inter-Quartile Range|Median
1275071|NCT00315445|Secondary|Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)|The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275072|NCT00315445|Secondary|Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)|The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0–2 ordinal scale from 0 = “Worse than prestudy medicine” to 2 = “Better than prestudy medicine.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275073|NCT00315445|Secondary|Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)|The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275074|NCT00315445|Secondary|Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)|The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275075|NCT00315445|Secondary|"Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Mental Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275076|NCT00315445|Secondary|"Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Emotional Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275077|NCT00315445|Secondary|"Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Social Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275078|NCT00315445|Secondary|"Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Vitality is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275079|NCT00315445|Secondary|"General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. General Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275090|NCT00315328|Primary|Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks||||ETDRS letter score||Standard Deviation|Mean
1275080|NCT00315445|Secondary|"Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Bodily Pain is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275081|NCT00315445|Primary|Pain Right Now, Mean Change From Baseline, Days 21–84 (LOCF)|Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.” Pain right now is presented as the LSmean [change from baseline] (SE).|Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
1275082|NCT00315445|Secondary|"Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)"|"The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. Physical Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275083|NCT00315445|Secondary|"Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)"|"The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. Physical Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84, or, if applicable, at early termination|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
1275084|NCT00315445|Primary|Pain on the Average, Mean Change From Baseline Days 21–84 (Last Observation Carried Forward [LOCF])|Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.|On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.|All 134 subjects randomized and received study drug were included in the intent-to-treat (ITT) and safety analyses. ITT Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from study because the informed consent was never obtained. This subject had no efficacy data but was included the analysis of discontinuation due to lack of efficacy.|||Units on a scale||Standard Error|Least Squares Mean
1275085|NCT00315341|Primary|Hepatic Safety|"Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner:~A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study~B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN~C: Either ALT or AST started > 2 x ULN, decreased (both ALT and AST) to < 2 x ULN, and remained < 2 x ULN~D: Either ALT or AST started > 2 x ULN and remained above 2 x ULN throughout the study"|24 Weeks|evaluable subjects stayed in treatment for 24 weeks and gave at least 4 blood samples for liver function tests during the treatment period|||participants|||Number
1275086|NCT00315328|Secondary|Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks||||ETDRS letter score||Standard Deviation|Mean
1275087|NCT00315328|Secondary|Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks||||participants|||Number
1275088|NCT00315328|Secondary|Mean Visual Acuity in the Fellow Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||ETDRS letter score||Standard Deviation|Mean
1275089|NCT00315328|Secondary|Distribution of Visual Acuity in the Fellow Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||participants|||Number
1275121|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 12)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|12 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
1283011|NCT00234286|Secondary|Do Not Resuscitate Order|Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
1275091|NCT00315328|Primary|Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks||||participants|||Number
1275092|NCT00315328|Primary|Mean Visual Acuity in the Amblyopic Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||ETDRS letter score||Standard Deviation|Mean
1275093|NCT00315328|Primary|Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|Primary analysis includes only patients who completed the 17 week exam between 13 and 26 weeks following randomization. No imputation was done if missed exam; analysis followed the intent to treat principle.|||participants|||Number
1275094|NCT00315328|Secondary|Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)|Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.|||Units on a scale||Standard Deviation|Mean
1275095|NCT00315328|Secondary|Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)|Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.|||Units on a scale||Standard Deviation|Mean
1275096|NCT00315328|Secondary|Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)|Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.|||Units on a scale||Standard Deviation|Mean
1275097|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia|"Stereoacuity is scored as seconds of arc with values of: <800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; <800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as within one level meaning change was -1, 0, or +1."|17 or 19 weeks||||Participants|||Number
1275098|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks||||Participants|||Number
1275099|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks||||Participants|||Number
1275100|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks||||Participants|||Number
1275101|NCT00315302|Secondary|Visual Acuity Distribution in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks||||Participants|||Number
1275102|NCT00315302|Secondary|Distribution of Change in Visual Acuity in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks||||Participants|||Number
1283012|NCT00234286|Primary|Presence of Order for Opioid Pain Medication|Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
1275103|NCT00315302|Secondary|Mean Change in Visual Acuity in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks||||logMAR units||Standard Deviation|Mean
1275104|NCT00315302|Secondary|Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|18 weeks|Not reported among subjects with severe amblyopia|||Participants|||Number
1275105|NCT00315302|Secondary|Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|18 weeks|Not reported among subjects with severe amblyopia|||Participants|||Number
1275106|NCT00315302|Primary|Distribution of Change in Visual Acuity in the Amblyopic Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks||||Participants|||Number
1275107|NCT00315302|Primary|Mean Change in Visual Acuity in the Amblyopic Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks||||logMAR units||Standard Deviation|Mean
1275108|NCT00315302|Primary|Visual Acuity Distribution in the Amblyopic Eye|"Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks||||Participants|||Number
1275109|NCT00315302|Primary|Visual Acuity Mean Score in the Amblyopic Eye|"Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks|Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.|||logMAR units||Standard Deviation|Mean
1275110|NCT00315146|Secondary|Lean Body Mass||Baseline visit (pre intervention) and 4month follow up (post intervention)||||kg||95% Confidence Interval|Least Squares Mean
1275111|NCT00315146|Primary|Appendicular Non-bone Lean Mass|Change in Appendicular Non-bone Lean Mass|Baseline visit (pre intervention) and 4month follow up (post intervention)||||kg||95% Confidence Interval|Least Squares Mean
1275112|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 12)|Subjects who reported being very satisfied with back care|12 weeks||||participants||95% Confidence Interval|Number
1275113|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 8)|Subjects who reported being very satisfied with back care|8 weeks||||participants||95% Confidence Interval|Number
1275114|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 4)|Subjects who reported being very satisfied with back care|4 weeks||||participants||95% Confidence Interval|Number
1275115|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 12)|Subjects who reported being very satisfied with back care|12 weeks||||participants||95% Confidence Interval|Number
1275116|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 8)|Subjects who reported being very satisfied with back care|8 weeks||||participants||95% Confidence Interval|Number
1275117|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 4)|Subjects who reported being very satisfied with back care|4 weeks||||participants||95% Confidence Interval|Number
1275118|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 12)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|12 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
1275119|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 8)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|8 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
1275120|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 4)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|4 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
1275132|NCT00315120|Primary|Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)|"Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%)."|12 weeks||||participants|||Number
1275133|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|4 weeks|Week 4 Data|||RMDQ Scale||Inter-Quartile Range|Median
1275134|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|12 weeks|Week 12 Data|||RMDQ Scale||Inter-Quartile Range|Median
1275135|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|8 weeks|Week 8 Data|||RMDQ Scale||Inter-Quartile Range|Median
1275136|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|4 weeks|Week 4 Data|||RMDQ Scale||Inter-Quartile Range|Median
1275137|NCT00315120|Primary|Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)|"Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%)."|12 weeks||||participants|||Number
1275138|NCT00315055|Secondary|Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability|Day 0 to Day 7 post any dose|Solicited reactions were assessed in all participants who received at least 1 injection of study vaccine (Safety Analysis Set) according to the vaccine actually received.|||Participants|||Number
1275139|NCT00315055|Secondary|Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet.|Day 90 (30 Days post-dose 3)|Geometric Mean Titers were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Titers||95% Confidence Interval|Geometric Mean
1275140|NCT00315055|Secondary|Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90).|Day 0 (pre-vaccination) and Day 30 post-dose 3|Anti-pertussis antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Percentage of Participants|||Number
1275141|NCT00315055|Secondary|Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.|Day 90 post first dose|Anti poliovirus antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Percentage of Participants|||Number
1275142|NCT00315055|Secondary|Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP.|Day 90 post first dose|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Percentage of Participants|||Number
1285327|NCT00192296|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 84|All subjects who received MEDI-528|||Participants|||Number
1275143|NCT00315055|Primary|Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.|Day 90 post first dose|Seroprotection against HBs was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Percentage of Participants|||Number
1275144|NCT00314951|Other Pre-specified|Global Cure|Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.|End of Study (Day 40)|The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.|||Percentage of Participants|||Number
1275145|NCT00314951|Secondary|Recurrence|Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.|Study days 11-40|The mITT population for subjects who met the primary endpoint of cure subjects, were analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.|||Percentage of Participants|||Number
1275146|NCT00314951|Primary|Cure Rate at End of Therapy|Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.|Study day 10 (+/- 2 days)|Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by >3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
1275147|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- MMSE|The mean change between baseline and post-treatment in quality of life as measured by the Mini Mental Status Exam (MMSE). Change is computed as the MMSE level at month 2 minus MMSE level at baseline. MMSE is an 11-item questionnaire used to measure global cognitive status with scores ranging from 0 to 30; higher scores are an indication of greater cognitive function.|baseline and 2 months|17 patients provided both a pre- and post-treatment assessment of MMSE.|||units on a scale||Standard Deviation|Mean
1275148|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- FLIE|The mean change from baseline in quality of life as measured by the Functional Living Index Emesis (FLIE) scale during the first 24 and 72 hours of cycle 1. Change at 24 hours was computed as the 24 hour FLIE assessment minus the baseline assessment; whereas, change at 72 hours was computed as the 72 hour FLIE assessment minus the baseline assessment. The FLIE consists of 18 items for nausea and appetite on a 7-point scale. The effect of nausea and vomiting is measured by physical activity, social, and emotional function. Higher scores indicate less difficulty and interference with nausea and vomiting. Scores for the two subscales (nausea and vomiting) range between 0 and 54.|baseline, 24 hours, and 72 hours|For cycle 1, 28 patients with a baseline and follow-up assessment are included in the analysis of change at 24 and 72 hours.|||units on a scale||Standard Deviation|Mean
1275149|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- FACT-Br|The mean change between baseline and post-treatment in quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br), where change is computed as quality of life at 2 months minus quality of life at baseline. The FACT-Br instrument consists of 54 items to assess physical(PWB), social and family (SWB), emotional (EWB), functional well-being (FWB), and additional brain cancer specific concerns (AC). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. PWB, SWB, and FWB are the sum of 7 items and have a possible range between 0 and 28. EWB ranges between 0 and 24, and is the sum of 6 items. AC is the sum of 19 items, and ranges between 0 and 76.|baseline and 2 months|19 patients provided both baseline and follow-up assessments; however, only 11 patients provided adequate information to compute the score for the additional brain cancer specific concerns subscale.|||units on a scale||Standard Deviation|Mean
1275150|NCT00314808|Primary|Unacceptable Toxicity Rate|Percentage of participants who experience one or more adverse events attributable to Dronabinol of the following types or grades: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities|2 months|All treated patients|||percentage of participants||95% Confidence Interval|Number
1275151|NCT00314808|Primary|Tolerability Rate|Percentage of participants where the 2 cycles of Dronabinol is tolerable. The treatment regimen is considered intolerable if (1) at least two adverse events of the following types that are attributed to Dronabinol during the 2 cycles of treatment occur: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities, or (2) Dronabinol treatment is terminated early due to adverse events|Two months|25 of the 33 patients treated with Dronabinol completed 2 cycles of protocol treatment or terminated protocol treatment due to adverse events. The remaining 8 patients are excluded from this tabulation as they terminated Dronabinol treatment before completion of 2 cycles of treatment for reasons unrelated to adverse events.|||percentage of participants||95% Confidence Interval|Number
1275152|NCT00314574|Secondary|Number of Participants Assessed for Frequency and Severity of Treatment-emergent Adverse Events|This outcome is represented in the adverse event section of the database.|Week 48|Safety Population: The safety-evaluable population comprised 848 patients (428 Xolair group and 420 placebo group). Patients in the safety-evaluable population were analyzed according to the actual treatment received. One subject was assigned to receive placebo but inadvertently received at least one dose of xolair during the study.|||participants|||Number
1275175|NCT00314327|Secondary|Negative Symptoms|Zero patients were analyzed as only one subject consented to the study and dropped out of the study before they were randomized. The negative symptoms that were going to be analyzed include: Affective Flattening, Alogia, Avolition /Apathy, and Anhedonia/Asociality|13 weeks|Zero patients were analyzed as only one subject consented to the study and dropped out of the study before they were randomized.||||||
1275176|NCT00314327|Primary|Treatment Response Based Upon BPRS and CGI Ratings||13 weeks|||||||
1275153|NCT00314574|Secondary|Change From Baseline in Overall Asthma-related Quality of Life|Change from baseline to week 48 in overall asthma-specific health-related quality of life, as measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score. The AQLQ(S) consists of 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; the overall score is the mean of these 32 items on a scale of 1 to 7 (1 = severe impairment, 7 = no impairment). Overall outcome achieved by mean visit minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.|||score on a scale||Standard Deviation|Mean
1275154|NCT00314574|Secondary|Change From Baseline in the Number of Puffs Per Day of Beta Agonist Rescue Medication|Change from baseline to week 48 in mean puffs per day of albuterol. Puffs per day was achieved by week 48 minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.|||puffs per day||Standard Deviation|Mean
1275155|NCT00314574|Secondary|Change From Baseline in Total Asthma Symptom Scores|Change from baseline to week 48 in Total Asthma Symptom Score (TASS), which included a nocturnal asthma score (0 to 4 scale), morning asthma symptoms (yes or no), and a daytime asthma symptom score (0 to 4 scale, total score range 0 to 9, higher TASS scores represent worse symptoms; breathlessness, tightness in chest, wheezing and cough. Score achieved by week 48 minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug. Ten patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.|||score on a scale||Standard Deviation|Mean
1275156|NCT00314574|Primary|Rate of Asthma Exacerbations Over the 48 Week Treatment Period|A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 48 week treatment period in each treatment group.|48 weeks|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo).|||exacerbation/patient-week|||Number
1275157|NCT00314366|Secondary|Total Severity Score (Reversible)|"For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress.~Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined."|baseline and 6 months||||units on a scale||Standard Deviation|Mean
1275158|NCT00314366|Secondary|Total Severity Score (Rest)|"For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest.~Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.~Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."|baseline and 6 months||||units on a scale||Standard Deviation|Mean
1275159|NCT00314366|Secondary|Total Severity Score (Stress)|"For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling.~Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.~Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."|baseline and 6 months||||units on a scale||Standard Deviation|Mean
1275160|NCT00314366|Secondary|Echocardiography (EF) Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|baseline and 6 months||||percentage of blood||Standard Deviation|Mean
1275161|NCT00314366|Secondary|Myocardial Oxygen Consumption (MVO2)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.|baseline and 6 months|data from 9 stem cell patients at 6 months, 10 at baseline|||ml/kg/min||Standard Deviation|Mean
1275162|NCT00314366|Secondary|Echocardiography Wall Motion Score Index (WMSI)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.|baseline and 6 months||||units on a scale||Standard Deviation|Mean
1275163|NCT00314366|Secondary|Left Ventricular End-Diastolic Volume (LVEDV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.|baseline and 6 months||||ml||Standard Deviation|Mean
1275164|NCT00314366|Secondary|Left Ventricular End-Systolic Volume (LVESV) (ml)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.|baseline and 6 months||||ml||Standard Deviation|Mean
1275165|NCT00314366|Secondary|Echocardiography (EF)Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|Baseline and 6 months||||percentage of blood||Standard Deviation|Mean
1275166|NCT00314366|Secondary|Canadian Cardiovascular (CCS) Angina Score|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).~Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1275167|NCT00314366|Secondary|New York Heart Association (NYHA) Classification|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.~Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"|Baseline and 6 months||||NYHA Functional class||Standard Deviation|Mean
1275168|NCT00314366|Primary|Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events|Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).|Baseline and 6 months|The data was analyzed for all participants in control and treated groups.|||participants|||Number
1275169|NCT00314353|Secondary|Duration of Response||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
1275170|NCT00314353|Secondary|Overall Survival||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
1275171|NCT00314353|Secondary|Toxicity - Adverse Events||Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
1275172|NCT00314353|Secondary|Objective Response Rate||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
1275173|NCT00314353|Primary|One-year Progression-free Survival (PFS)|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.|Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Primary outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
1275174|NCT00314340|Primary|3 Scores on the Addiction Research Center Inventory (ARCI)|The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine–Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital–Chorpromazine–Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria.|0, 60, 120, 180, 240, or 300 minutes|Treatment effects at baseline, 60, 120, 180, 240, and 300 min were assessed with repeated measures ANOVA. A liner mixed-effects model with inclusion of interaction terms (1) treatment and time and (2) random order visit number and time was performed.|||scores on a scale||Standard Deviation|Mean
1275206|NCT00313820|Secondary|Clinical Global Impression of Change (CGIC)|CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 12|ITT|||scores on scale||Standard Error|Least Squares Mean
1275177|NCT00314262|Primary|Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma|Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.|Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.||||participants|||Number
1275178|NCT00314262|Primary|Clinical Outcome: Documented Progression|Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.|12 months from time of enrollment||||participants|||Number
1275179|NCT00314262|Primary|Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4|Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months. Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months. Dose escalation followed a standard 3+3 escalation design.|12 months from time of enrollment||||participants|||Number
1275180|NCT00314249|Secondary|Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12|"Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains & 2 component summaries (mental and physical); assessing quality of life, health & functional status.~SF-36 PCS: weighted summary of physical function using all 8 domains.~Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.~SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time."|Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase, values were imputed using the Last Observation Carried Forward (LOCF) approach.|||units on scale||Standard Error|Mean
1275181|NCT00314249|Primary|Composite Pain Responder Status|"Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of very much improved or much improved."|At the end of three-month stable dose treatment phase|The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).|||Pain Responder Participants|||Number
1275182|NCT00314249|Primary|Composite Syndrome Responder Status|"Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of very much improved and much improved; and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)"|At the end of the three-month stable dose treatment phase|The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of the three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).|||Syndrome Responder Participants|||Number
1275183|NCT00314249|Secondary|Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.|"Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.~MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1=yes, that is true and 5=no, that is not true."|Baseline through end of week 12 (Visit TX12)|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments at the end of week 12 (Visit TX12), values were imputed using Last Observation Carried Forward (LOCF).|||units on scale||Standard Error|Mean
1275184|NCT00314249|Secondary|Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.|"Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.~PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: Since the start of the study, overall my fibromyalgia is: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse."|Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).|||units on scale||Standard Error|Mean
1275207|NCT00313820|Secondary|Patient Global Impression of Change (PGIC)|PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 12|ITT|||scores on scale||Standard Error|Least Squares Mean
1275185|NCT00314249|Secondary|Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase|"Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.~PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain)."|Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments for weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).|||units on scale||Standard Error|Mean
1275186|NCT00314236|Secondary|Frequency of Adverse Events Between Study Groups||12 months|AEs will be coded and tabulated separately by system organ class (SOC) and individual preferred terms (PTs). The number and percentage of subjects who experienced AEs will be summarized in decreasing frequency by using the medical dictionary for regulatory activities (MedDRA) dictionary.|||Percentage of participants|||Number
1275187|NCT00314236|Secondary|Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)|The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function.|12 months|Secondary efficacy was evaluated based on pain, stiffness, and function, as well as the macroscopic nature of the cartilage repair. Measurements of pain, stiffness, and function were made at 3, 6, and 12 months post-treatment using the WOMAC questionnaire and SF-36v2. WORMS scoring was conducted on 12-month post-treatment MRI scans.|||Units on a scale||Standard Error|Least Squares Mean
1275188|NCT00314236|Primary|Repair Cartilage T2 Relaxation Time|Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).|12 months|Sample size for repair tissue quality was calculated, using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 10. Under these assumptions, the sample size per group was calculated to be 11 subjects (or 22 subjects in total)|||milliseconds||Standard Error|Least Squares Mean
1275189|NCT00314236|Primary|Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.|Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.|12 months|Sample size for degree of lesion filling was calculated using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 15. Under these assumptions, the sample size per group was calculated to be 23 subjects (or 46 subjects in total)|||Percentage of lesion fill||Standard Error|Least Squares Mean
1275190|NCT00314145|Primary|Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®|"Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.~Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash."|Day 0 (Pre-vaccination) up to 60 days post-first vaccination|Treatment emergent local adverse events and systemic reactions were assessed in all subjects who had at least one injection (ChimeriVax™-JE, JE-Vax®, or placebo), according to the treatment actually received (Safety Population).|||Participants|||Number
1275191|NCT00314145|Secondary|Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).|Day 60 post-first vaccination|Antibody titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).|||Participants|||Number
1275192|NCT00314145|Secondary|Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).|Up to Day 60 post-first vaccination|Geometric mean titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).|||Titers||95% Confidence Interval|Geometric Mean
1275193|NCT00314145|Primary|Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.|Up to Day 60 post-first vaccination|Seroconversion was assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).|||Participants|||Number
1275194|NCT00314132|Primary|Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo|"Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.~Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported."|Day 0 up to 30 days post-vaccination|Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).|||Participants|||Number
1275195|NCT00314132|Primary|Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo|"Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered actively solicited through Day 30."|Day 0 up to 30 days post-vaccination|Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).|||Participants|||Number
1275196|NCT00314106|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|33 months||||Participants|||Number
1275197|NCT00314106|Primary|Complete Response|"Determine if the combination of high dose aldesleukin, reinfused cells after lymphocyte depleting chemotherapy and 1200 cGy total body irradiation (TBI) is able to be associated with a modest fraction of patients with metastatic melanoma who can experience a complete response to therapy.~Complete response (CR) is a disappearance of all target lesions."|33 months||||Participants|||Number
1275198|NCT00313911|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable."|Day 0 up to Day 7 Post-injection|Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group.|||Participants|||Number
1275199|NCT00313911|Secondary|Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo|"Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.~Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively."|Day 30 post-dose 3|Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
1275200|NCT00313911|Secondary|Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo|Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.|Day 30 post-dose 3|Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.|||Titers||95% Confidence Interval|Geometric Mean
1275201|NCT00313911|Primary|Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.|High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.|Day 0 up to Day 7 post-injection|The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group.|||Participants|||Number
1275202|NCT00313846|Secondary|"Daily Maximum Pain Right Now Score for the Primary Osteoarthritis (OA) Pain Site"|The daily maximum ‘pain right now’ score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. “Pain right now” scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).|7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.|Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.|||units on a scale||Standard Error|Mean
1275203|NCT00313846|Primary|The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.|"Inadequate analgesia:~“average pain over the last 24 hours” score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;~>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;~ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia."|"Double-blind phase ( 28 days): reaching inadequate analgesia on any 2 days of the 7-day dosing periods"|The Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.|||days||Standard Error|Mean
1275204|NCT00313820|Secondary|QANeP - Pain Rating Scales|Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).|Baseline, Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12 [LOCF].|||scores on scale||Standard Deviation|Mean
1275205|NCT00313820|Secondary|Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold|"QANeP: assessment of sensory threshold: subject responds yes when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram [g]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline)."|Baseline, Week 12|ITT; Week 12 [LOCF].|||scores on scale||Standard Deviation|Mean
1281109|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
1275208|NCT00313820|Secondary|EQ-5D - VAS|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Week 12|ITT|||scores on scale||Standard Error|Least Squares Mean
1275209|NCT00313820|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, “confined to bed”). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Week 12|ITT|||scores on scale||Standard Error|Least Squares Mean
1275210|NCT00313820|Secondary|Hospital Anxiety and Depression Scale (HADS) - ITT Population|HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Week 12|ITT; Week 12 [LOCF]|||scores on scale||Standard Error|Least Squares Mean
1275211|NCT00313820|Secondary|Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep|MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.|Week 12|ITT|||participants|||Number
1275212|NCT00313820|Secondary|Medical Outcome Study (MOS) Sleep Scale|MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1275213|NCT00313820|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.|Week 12|ITT; (N) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12/Last observation carried forward (LOCF).|||scores on scale||Standard Error|Least Squares Mean
1275214|NCT00313820|Secondary|Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only|SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.|Week 12|ITT|||millimeters||Standard Error|Least Squares Mean
1275215|NCT00313820|Secondary|Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])|DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.|Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; endpoint = Week 12 or ET.|||scores on scale||Standard Error|Least Squares Mean
1275216|NCT00313820|Secondary|Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint|50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.|Baseline, Week 12|ITT; endpoint = Week 12 or ET|||participants|||Number
1275217|NCT00313820|Secondary|Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint|30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.|Baseline, Week 12|ITT; endpoint = Week 12 or ET|||participants|||Number
1275218|NCT00313820|Secondary|Pain Score as Measured by DPRS|Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.|Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12|ITT; (n) = number of participants with analyzable data at observation for pregabalin and placebo, respectively; weeks as specified in timeframe through Week 12 [ET]|||scores on scale||Standard Error|Least Squares Mean
1275246|NCT00313443|Primary|Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.|Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.|One single measure, taken just before daily administration||||Correlation coefficient R|||Number
1275219|NCT00313820|Primary|Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)|Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.|Up to Week 12|Intent to Treat (ITT): received at least 1 dose study medication and completed at least 1 post-baseline assessment. Endpoint = Week 12 or ET|||scores on scale||Standard Error|Least Squares Mean
1275220|NCT00313781|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.||||||
1275221|NCT00313781|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.||||||
1275222|NCT00313781|Secondary|Maximum Observed Plasma Concentration (Cmax) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.||||||
1275223|NCT00313781|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871|Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.|Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.||||||
1275224|NCT00313781|Secondary|Pain Measured by the Modified Brief Pain Inventory‑Short Form (mBPI‑sf Modified Pfizer)|"The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an X in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block."|Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)|The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the PRO summary irrelevant 2) lack of resources as the program was terminated.||||||
1275225|NCT00313781|Secondary|Quality of Life Measured by the Functional Assessment of Cancer Treatment‑Prostate (FACT‑P)|The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.|Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)|The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the patient reported outcome (PRO) summary irrelevant 2) lack of resources as the program was terminated.||||||
1275226|NCT00313781|Secondary|Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs|Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs.|Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)|Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.|||Number of IGF-1R positive CTCs/7.5 mL||Standard Deviation|Mean
1275227|NCT00313781|Secondary|Total Number of Circulation Tumor Cells (CTCs)|Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.|Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)|Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.|||Number of CTCs/7.5 mL||Standard Deviation|Mean
1275228|NCT00313781|Secondary|Population PK Parameters of CP-751,871|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations|Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|||||||
1275229|NCT00313781|Secondary|Human Anti-human Antibody (HAHA) at the Last Follow-up Visit|Levels of HAHA in serum were detected at the last follow-up visit.|The last follow-up visit (150 days post last dose)|All participants who were enrolled in the study, received at least one assigned treatment and had HAHA available assessment.|||mg/dl||Standard Deviation|Mean
1275230|NCT00313781|Secondary|Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)|Levels of HAHA in serum were detected at baseline.|Baseline (Day 1 of Cycle 1)|All participants who were enrolled in the study, received at least one assigned treatment and had available HAHA assessment.|||mg/deciliter (dl)||Standard Deviation|Mean
1275247|NCT00313443|Primary|Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.|Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.|One single measure||||Correlation coefficient R|||Number
1275231|NCT00313781|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.|Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)|Full analysis set included all participants who were enrolled into the study and received at least one assigned treatment.|||Months||95% Confidence Interval|Median
1275232|NCT00313781|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Best Response|Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.|Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)|Response-evaluable population: All enrolled participants who had a baseline PSA reference value and received at least one dose of assigned treatment with the exception of those participants without symptomatic or objective progression (participants with PSA progression only) who withdraw consent prior to Cycle 3.|||Percentage of participants||90% Confidence Interval|Mean
1275233|NCT00313716|Secondary|Incidence of Infection|occurrence of infection was a primary safety outcome for the transfusion threshold randomization|within 30 days after injury|Intention to treat analysis|||participants|||Number
1275234|NCT00313716|Secondary|Incidence of Adult Respiratory Distress Syndrome (ARDS)|development of ARDS was a primary safety outcome for the transfusion threshold randomization|within 30 days after injury|Intention to treat analysis|||participants|||Number
1275235|NCT00313716|Secondary|Mortality Rate|mortality rate was a secondary outcome measure for the Epo randomization, and a primary safety outcome measure for the transfusion threshold randomization|up to 6 months after injury|Intention to treat analysis|||participants|||Number
1275236|NCT00313716|Secondary|Disability Rating Scale|Disability rating scale was a secondary outcome measure for the transfusion threshold analysis. Disability rating scale ranges from 0 to 30, with 30 indicating death and 0 indicating return to normal status.|at 6 months|Intention to treat analysis|||units on a scale||Inter-Quartile Range|Median
1275237|NCT00313716|Primary|Glasgow Outcome Scale|Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead)|at 6 months after injury|Intention to treat. Multiple imputation for missing 6-month GOS data was performed assuming data were missing at random using chained equations (R, R Foundation for Statistical Computing).The imputation was based on a logistic regression model with baseline covariates. Results were aggregated over 20 imputed sets using variance formula by Rubin.|||participants|||Number
1275238|NCT00313703|Other Pre-specified|Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal|Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.|3 months|A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.|||participants|||Number
1275239|NCT00313703|Primary|Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge|Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain|24 hours after Emergency Department (ED) discharge|A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.|||Participants|||Number
1275240|NCT00313612|Secondary|Time to Disease Progression by RECIST and/or CA 125|Time to disease progression by RECIST and/or CA 125|Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks||||months||95% Confidence Interval|Median
1275241|NCT00313612|Primary|Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)|Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.|Every two cycles for up to 24 weeks.|30 patients were analyzed. Eight patients discontinued treatment before 2 cycles.|||participants|||Number
1275242|NCT00313586|Primary|Proportion of Patients With Clinical Response|"Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria:~World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett)~Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.)~Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)"|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry.|All treated patients are included in the analysis.|||Proportion of patients||95% Confidence Interval|Number
1275243|NCT00313443|Secondary|Presence of Any Adverse Effect Attributable to Amiodarone.|Number of patients developing adverse effects by amiodarone leading to withdrawal or specific treatment (i.e. thyroid hormone treatment)|Cumulated time on amiodarone (varies in each patient)||||Patients|||Number
1275244|NCT00313443|Secondary|Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations|Number of patients having complications (if any) caused by fat tissue needle aspirations|24 hours after needle aspiration||||Patients|||Number
1275245|NCT00313443|Primary|Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.|Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.|Cumulated time on amiodarone (varies in each patient)||||Logistic regression OR|||Number
1286167|NCT00177255|Secondary|Overall Response Rate|The number of responders (complete responders + partial responders) divided by the number of evaluable patients.|Every 2 cycles (6 weeks)||||percentage of participants||95% Confidence Interval|Number
1275248|NCT00313313|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
1275249|NCT00313313|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
1275250|NCT00313313|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
1275251|NCT00313313|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.|||percent||Standard Error|Mean
1275252|NCT00313300|Secondary|Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.|||percentage of participants||95% Confidence Interval|Number
1275253|NCT00313300|Secondary|Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B|Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.|Day of randomization up to high dose termination, 1-Oct-2007|Participants who were concomitantly randomized in Phase B were summarized.|||participants|||Number
1275254|NCT00313300|Secondary|Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.|||percentage of participants||95% Confidence Interval|Number
1275255|NCT00313300|Secondary|Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B|Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants randomized in Phase B only who received at least one dose of placebo or apixaban were summarized.|||percentage of participants||95% Confidence Interval|Number
1275256|NCT00313300|Secondary|Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B|Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.|Day of randomization and ends on high dose termination date, 1-Oct-2007|Participants who were concomitantly randomized in Phase B only were summarized (start of Phase B, March 2007, to termination of high doses in Phase B, October 2007) .|||participants|||Number
1275257|NCT00313300|Secondary|Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).|from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban were analyzed.|||percentage of participants||95% Confidence Interval|Number
1275377|NCT00311766|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||70 days|The population for safety analysis included all patients who were randomized and received at least one dose of study medication and had at one safety parameter recorded.|||Participants|||Number
1275258|NCT00313300|Secondary|Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants|Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B|Day of randomization to 182 days after day of randomization (183 days)|Randomized participants were summarized.|||participants|||Number
1275259|NCT00313300|Secondary|Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.|first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban are summarized. The analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.|||percentage of participants||95% Confidence Interval|Number
1275260|NCT00313300|Secondary|Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants|Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.|Randomization to 182 days after randomization (183 days)|Participants who randomized to placebo or low dose apixaban are summarized. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.|||participants|||Number
1275261|NCT00313300|Primary|Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.|From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the primary analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.|||percentage of participants||95% Confidence Interval|Number
1275262|NCT00313209|Secondary|Shortness of Breath Questionnaire (SOBQ) Total Score|"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity."|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
1275263|NCT00313209|Secondary|Transition Dyspnea Index (TDI) Focal Score|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
1275264|NCT00313209|Secondary|COPD Exacerbation Rate (Mild, Moderate or Severe)|Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [ATS / ERS 2005].|24 weeks treatment period|ITT analysis|||exacerbations per patient per year||95% Confidence Interval|Mean
1275265|NCT00313209|Secondary|Post-bronchodilator FEV1|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
1275266|NCT00313209|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
1275988|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|270 days||||Percentage of participants|||Number
1275267|NCT00313170|Secondary|Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes|The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes|Baseline to 12 weeks||||litres per hour||Standard Deviation|Mean
1275268|NCT00313170|Secondary|Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body|The measure of dispersion for mean population clearance is based on the estimated inter-individual variance.|Baseline to 12 weeks|Participants who had PK samples only|||litres per hour||Standard Deviation|Mean
1275269|NCT00313170|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD, provided that the SD was present at least 154 days from randomisation (ie. SD>=24 weeks - with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria in Solid Tumours) scan data up to the data cut-off, 13th June 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation.||||Percentage of patients|||Number
1275270|NCT00313170|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response (CR) or confirmed Partial Response (PR)|RECIST tumour assessments were carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut-off on 13th June 2008|||||||
1275271|NCT00313170|Secondary|Time to Progression (TTP)|Median time (in days) from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut off on 13th June 2008||||Days||Full Range|Median
1275272|NCT00313170|Primary|Objective Response (OR)|Number of participants who were objective responders over the number of participants evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diameters of the measurable lesions + no new lesions + no progression of non-measurable lesions)|RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation to until data cut off on 13th June 2008||||Percentage of patients|||Number
1275273|NCT00313144|Secondary|ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening|"All IgG and IgM titers at screening were ≤ 4. A 2-dilution step increase was defined as follows:~The titer at each 6-month visit must be ≥ 4 when the screening titer = 0~Each 6-month visit titer / screening titer should be ≥ 4. 6 month window periods are: baseline to ≤6 months, >6 months to ≤12 months, >12 months to ≤18 months, and >18 months to ≤24 months"|Baseline to 24 Months|Subjects who participated in the blood draws with data available during each window period|||Participants|||Number
1275274|NCT00313144|Secondary|Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening|Summary of changes in hepatic (total bilirubin) and renal (Blood urea nitrogen (BUN), creatinine) parameters from screening/baseline through each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Subjects who participated in the blood draws with data available during each window period|||mg/dL||Full Range|Median
1275275|NCT00313144|Secondary|Hepatic Chemistry Parameters: Change From Baseline/Screening|Summary of changes in hepatic (total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase) parameters from screening/baseline through each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Subjects who participated in the blood draws with data available during each window period|||U/L||Full Range|Median
1275276|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses'|Number of steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||Steroid Pulse Courses||Standard Deviation|Mean
1275277|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses'|Number of participants receiving steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||Participants|||Number
1275278|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses'|Number of antibiotic courses (i.e. number of antibiotic prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||Antibiotic courses||Standard Deviation|Mean
1275279|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics'|Number of participants taking antibiotics one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||Participants|||Number
1275280|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital'|Mean LOS during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Participants with data available during each window period|||Days||Standard Deviation|Mean
1275281|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations'|Number of participants with indicated number of hospitalizations during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 Months|Participants with data available during each window period|||Participants|||Number
1275282|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits'|Mean number of ER visits one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||ER visits per time period||Standard Deviation|Mean
1275283|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits'|Number of participants with indicated number of ER visits (0, 1, 2, 3, ≥4 ER visits per participant) during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 Months|Participants with data available during each window period|||Participants|||Number
1275284|NCT00313144|Primary|HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months|SF-36 Scores- baseline thru 24 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 24 months|Participants with baseline and participating during the period from baseline to ≤24 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275285|NCT00313144|Primary|HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months|SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 12 months|Participants with baseline and participating during the period from baseline to ≤18 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275286|NCT00313144|Primary|HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months|SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 12 months|Participants with baseline and participating during the period from baseline to ≤12 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275287|NCT00313144|Primary|HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months|SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The MCS is a summary scale of the dimensions vitality, social functioning, role emotional, and mental health Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275288|NCT00313144|Primary|HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months|SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275289|NCT00313144|Primary|HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275290|NCT00313144|Primary|HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275291|NCT00313144|Primary|HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275292|NCT00313144|Primary|HRQoL 'Vitality (VT)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275293|NCT00313144|Primary|HRQoL 'General Health (GH)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275294|NCT00313144|Primary|HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275295|NCT00313144|Primary|HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275296|NCT00313144|Primary|HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
1275297|NCT00313014|Secondary|The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.|"The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).~Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance."|Weeks 4, 8, 12 of the double-blind phase|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Error|Mean
1275298|NCT00313014|Secondary|Oswestry Disability Index (ODI) Score (V 2.0)|"The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.~The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)"|Weeks 4, 8, 12|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Error|Mean
1275299|NCT00313014|Secondary|Mean Daily Number of Supplemental Analgesic Tablets|The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase|Double-blind phase (84 days)|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||tablets||Standard Error|Mean
1275300|NCT00313014|Primary|Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.|"Subjects were evaluated during the double-blind phase for average pain over the last 24 hours prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)"|Last 24 hours score at weeks 4, 8, 12 of the double-blind phase|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Error|Mean
1275301|NCT00312923|Secondary|Triglycerides||12 weeks||||mg/dl||Standard Deviation|Mean
1275302|NCT00312923|Primary|LDL Cholesterol|Low density lipoprotein cholesterol|12 weeks||||mg/dl||Standard Deviation|Mean
1275303|NCT00312897|Secondary|Clinician's Global Improvement Scale (CGI)|a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|baseline and 10-week treatment phase|3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results|||units on a scale||Standard Deviation|Mean
1275628|NCT00310037|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.|Duration of treatment (up to approximately 2 years)||||participants|||Number
1275304|NCT00312897|Primary|Children's Depressive Rating Scale - Revised (CDRS-R)|It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).|baseline and 10-weeks|3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results|||units on a scale||Standard Deviation|Mean
1275305|NCT00312884|Primary|Number of Hospitalisations (All Cause)||from randomisation for 180 days||||Number of hospitalisations|||Number
1275306|NCT00312884|Primary|Number of Days Spent in Hospital||From randomisation date for 180 days||||days||Inter-Quartile Range|Median
1275307|NCT00312884|Primary|Patients Hospitalised (All Cause)||From randomisation date to 180 days||||participants|||Number
1275308|NCT00312884|Primary|Days Alive and Outside of Hospital|Days alive and outside of hospital (i.e. not admitted)|From date of randomisation for 180 days||||Days||Inter-Quartile Range|Median
1275309|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
1275310|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
1275311|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
1275312|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
1275313|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
1275314|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
1275315|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
1275316|NCT00312858|Other Pre-specified|Antibody Response to Varicella - Geometric Mean Titer|Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL|6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)|Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1275317|NCT00312858|Other Pre-specified|Antibody Response to Hepatitis A – Geometric Mean Titer|Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus|4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)|Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures|||mIU/mL||95% Confidence Interval|Geometric Mean
1275318|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275319|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1286168|NCT00177255|Primary|Overall Survival|The time interval between the date on which a patient first received protocol treatment and the documented date of death.|2 years||||Months||95% Confidence Interval|Median
1275320|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275321|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275322|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275323|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275324|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275325|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275326|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275327|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience.|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275328|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275329|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
1275330|NCT00312858|Primary|Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers|Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay|6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures|||mcg/mL||95% Confidence Interval|Geometric Mean
1275331|NCT00312858|Primary|Antibody Response to Varicella - Participants With a Serological Response|Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)|6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)|Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.|||Participants|||Number
1275332|NCT00312858|Primary|Antibody Response to Hepatitis A - Participants With a Serological Response|Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus|4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)|Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.|||Participants|||Number
1275333|NCT00312845|Secondary|Overall Response Rate|Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.|Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.|The response-evaluable population was defined as all subjects in the ITT population who received at least 1 dose of VELCADE or rituximab, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline, and had at least 1 post-baseline disease assessment by independent radiology reviewers/IRC.|||participants|||Number
1275642|NCT00309907|Secondary|Plasma Cytokine IL6 Level|Estimated mean and standard error of IL6 level|From baseline to days 7 and 28|Plasma samples were available for biomarker analysis in 26 patients. The data were intended to be analyzed for all subjects, therefore, combined result is reported.|||pg/ml||Standard Error|Mean
1275334|NCT00312845|Primary|Progression Free Survival|Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.|Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.|Intention to treat (ITT) population is defined as all patients randomized to the trial.|||days||95% Confidence Interval|Median
1275335|NCT00312728|Secondary|Number of Participants With Selected Adverse Events|"Number of participants with selected adverse events (all grades based on NCI CTCAE) included any grade CNS hemorrhage, any grade pulmonary hemorrhage, any grade gastrointestinal (GI) perforation, Grade ≥ 2 arterial thromboembolic event, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 non-CNS non-pulmonary hemorrhage, Grade ≥ 3 proteinuria, Grade ≥ 3 proteinuria, Grade ≥ 3 hypertension, any serious adverse event*, and any adverse event leading to study treatment discontinuation.~*For serious adverse events, please see Adverse Event Reporting Section."|From start of bevacizumab treatment to 60 days following discontinuation of bevacizumab (up to 2 years)|The safety-evaluable population consisted of all patients who received at least one dose of bevacizumab.|||participants|||Number
1275336|NCT00312728|Secondary|Number of Participants With OS in First-line and Second-line Settings [1−Year or More Survival]|To assess the number of participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The efficacy-evaluable population consisted of all patients who received at least one dose of bevacizumab.|||participants|||Number
1275337|NCT00312728|Secondary|OS in First-line and Second-line Settings|To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The efficacy-evaluable population consisted of all patients who received at least one dose of bevacizumab.|||Months||95% Confidence Interval|Median
1275338|NCT00312728|Secondary|Number of Participants With Overall Survival (OS) in First-line Setting [1−Year or More Survival]|Number of Participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The first-line efficacy-evaluable population consisted of 70 patients who received at least one dose of bevacizumab.|||participants|||Number
1275339|NCT00312728|Secondary|Overall Survival (OS) in First-line Setting|To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The first-line efficacy-evaluable population consisted of 70 patients who received at least one dose of bevacizumab.|||Months||95% Confidence Interval|Median
1275340|NCT00312728|Primary|Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage|"The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage.~Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death"|From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)|The safety-evaluable population consisted of all patients who received at least one dose of bevacizumab.|||percentage of participants||90% Confidence Interval|Number
1275341|NCT00312702|Secondary|Anti-LSA-1 Antibody Response in Titer Units|Anti-LSA-1 Antibody Response in Titer Units on days 0, 28, 42 and 84|days 0, 28, 42 (challenge day) and 84|Low dose group didn't participate in challenge (day 42) and day 84|||Titer units||Full Range|Median
1275342|NCT00312702|Primary|Safety - Most Frequently Reported Adverse Events and Grade|"An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to study drug or clinically significant.~Grade 1: Mild Grade 2: Moderate Grade 3: Severe"|30 days post vaccination|The AE's were tabulated and summarized by subject and treatment groups. No additional analyses were performed. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe Infectivity Controls were not included in this analysis.|||Number of adverse events|||Number
1275343|NCT00312663|Secondary|Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84|Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84|Days 0, 28, 42, and 84|nAnti-LSA-1 Antibody Response in Titer units on Days 0, 28, 42 and 84|||Titer units||Full Range|Median
1275344|NCT00312663|Primary|Safety - Most Frequently Reported Adverse Events and Grade|An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to the study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe|30 days post vaccination|"The AE's were tabulated and summarized by subject and treatment groups. No additional analyses were performed. Subjects from the IC group were not evaluated for AE's and there for not included in the data.~Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe"|||adverse events|||Number
1275345|NCT00312572|Primary|The Percentage of Subjects Who Completed the 14-day Double-blind Phase.|The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).|14 days|Full Analysis Population: (N = 198) consisted of all subjects who were randomized into the double-blind phase, received at least 1 dose of BTDS during the double-blind phase, and had at least 1 efficacy observation during the double-blind phase, and had no evidence of impaired liver function at screening and prerandomization.|||Percentage of Participants||95% Confidence Interval|Number
1275346|NCT00312494|Secondary|Anonymized Pharmacogenomic Blood Draw|Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.|Baseline|All subjects eligible (optional consent); samples were not to be analyzed as part of the current protocol and the analysis was not to be covered by the statistical analysis plan.|||mg|||Number
1275347|NCT00312494|Secondary|Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score|LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations.|||scores on scale||Standard Error|Least Squares Mean
1275348|NCT00312494|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score|GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations.|||scores on scale||Standard Error|Least Squares Mean
1275349|NCT00312494|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score|PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1275350|NCT00312494|Secondary|Clinical Global Impression - Improvement (CGI-I) Scale Scores|CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected.|Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1275351|NCT00312494|Secondary|Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).|Baseline, Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1275352|NCT00312494|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).|Baseline, Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1275353|NCT00312494|Secondary|Change From Baseline to Week 1 and Week 2 in YMRS|YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).|Baseline, Week 1, Week 2|ITT population excluding data from 2 sites that were closed to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
1275354|NCT00312494|Primary|Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)|YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).|Baseline, Week 3|Intent to Treat population (ITT): all randomized subjects who received at least 1 dose of double-blind medication, who had 1 baseline and at least 1 post-baseline primary efficacy evaluation; excluding data from 2 sites that were closed due to Good Clinical Practices (GCP) deviations.|||scores on scale||Standard Error|Least Squares Mean
1275355|NCT00312377|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)|"The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.~Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.~A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days."|FACT-L questionnaires are to be administered every 3 weeks after randomisation||||Weeks||Inter-Quartile Range|Median
1275378|NCT00311766|Secondary|Number of Participants Whose Wounds Have Healed|Wound healing means that the wound has closed without any drainage|56 days|The population for efficacy analysis will be the Full Analysis (FA) population. The FA analysis included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded.|||participants|||Number
1275356|NCT00312377|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).|"The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items.~Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.~A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days."|FACT-L questionnaires are to be administered every 3 weeks after randomisation||||Weeks||Inter-Quartile Range|Median
1275357|NCT00312377|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression||||Weeks||Full Range|Median
1275358|NCT00312377|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.|RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression||||Participants|||Number
1275359|NCT00312377|Secondary|Objective Response Rate (ORR)|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression||||Participants|||Number
1275360|NCT00312377|Secondary|Overall Survival (OS) in the Female Population|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||Months||95% Confidence Interval|Median
1275361|NCT00312377|Secondary|Overall Survival (OS) in the Overall Population|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||Months||95% Confidence Interval|Median
1275362|NCT00312377|Primary|Progression-Free Survival (PFS) in the Female Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.|RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months||||Weeks||95% Confidence Interval|Median
1275363|NCT00312377|Primary|Progression-Free Survival (PFS) in the Overall Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.|RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months||||Weeks||95% Confidence Interval|Median
1275364|NCT00312338|Primary|Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0, Day 42||||Percent of resistant isolates|||Number
1275365|NCT00312338|Primary|Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0, Day 42||||Percent of resistant isolates|||Number
1275366|NCT00312338|Primary|Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0 and Day 42||||Percent of resistant isolates|||Number
1275428|NCT00311311|Secondary|Number of Participants Who Used Anti-hypertensive Medications|"Participants who reported yes for taking anti-hypertensive medications as concomitant medication."|From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||participants|||Number
1275367|NCT00312221|Secondary|The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase|The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12 of the Double-blind Phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||Units on a scale||Standard Error|Mean
1275368|NCT00312221|Secondary|The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase|"The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.~The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst)."|Weeks 4, 8 and 12 of the double-blind phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||Units on a scale||Standard Error|Mean
1275369|NCT00312221|Secondary|The Mean Daily Number of Supplemental Analgesic Medication Tablets|The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.|Double-blind phase (84 days)|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||Tablets||Standard Error|Mean
1275370|NCT00312221|Primary|“Average Pain Over the Last 24 Hours” Scores at Weeks 4, 8, and 12 of the Double-blind Phase.|The “average pain over the last 24 hours” score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).|Weeks 4, 8, and 12 of the double-blind phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||Units on a scale||Standard Error|Mean
1275371|NCT00312208|Secondary|Death From Any Cause (Overall Survival)|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|Median follow-up of 65 months|The analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median survival time, median time-to-event was not reached in any group; therefore, number of participants who died was presented.|||Participants|||Number
1275372|NCT00312208|Primary|Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)|The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|Median follow-up 65 months|The primary efficacy analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median disease free survival time, median time-to-event was not reached in any group; therefore, number of participants with relapse was presented.|||Participants|||Number
1275373|NCT00312195|Secondary|The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).|The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.|||Tablets||Standard Error|Least Squares Mean
1275374|NCT00312195|Secondary|The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase|"Note: The total numbers of Subjects w/ineffective treatment or who discont'd for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS."|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.|||participants|||Number
1275375|NCT00312195|Secondary|Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment|"The time of ineffective treatment was calculated as the earliest of the following:~The date the subject first took >1 gram of acetaminophen,~The visit date when ineffective treatment was first determined, or~The date the last patch was removed."|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.|||Days||Standard Error|Mean
1275376|NCT00312195|Primary|The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.|"Ineffective treatment was defined as:~Subject took >1 gram of acetaminophen in a 24-hour period, or~Subject required a change in transdermal patch (TDS) dose, or~Subject had difficulty in keeping the TDS on, or~Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).~Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment."|Double-blind phase (14 days)|The Full Analysis Population (N = 266) for efficacy analyses included all subjects who were randomized and provided at least 1 efficacy assessment in the double-blind phase.|||participants|||Number
1275643|NCT00309907|Secondary|Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0|Grade 3-5 organ toxicities attributable to etanercept.|Up to 56 days|28 patients evaluable for this outcome.|||Patients|||Number
1275379|NCT00311584|Primary|Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)|The patient’s best overall response obtained during Reporting Periods 1 and 2 will be scored as “best response”. Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).|up to 6 courses of therapy, or about 6 months|Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.|||participants|||Number
1275380|NCT00311402|Post-Hoc|Number of Patients With Composite Endpoint of Stroke or Major Bleeding|This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage, subarachnoid haemorrhage and major bleeding. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275381|NCT00311402|Post-Hoc|Number of Patients With Intracranial Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275382|NCT00311402|Post-Hoc|Number of Patients With Stroke|This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage and subarachnoid haemorrhage. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275383|NCT00311402|Secondary|Number of Patients With Ischemic Vascular Event Composite Endpoint|This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275384|NCT00311402|Secondary|Number of Patients With Other Vascular Events|This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275385|NCT00311402|Secondary|Number of Patients With Acute Coronary Syndrome (ACS)|ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275386|NCT00311402|Secondary|Number of Patients With Transient Ischemic Attack (TIA)|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275387|NCT00311402|Secondary|Number of Patients With Subarachnoid Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275388|NCT00311402|Secondary|Number of Patients With Brain (Cerebral) Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275389|NCT00311402|Primary|Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
1275390|NCT00311376|Secondary|Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire|Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients’ lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). A positive change from baseline represents an improvement|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)|||Number on a Scale (Score)||Standard Deviation|Mean
1275391|NCT00311376|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)|||Centimeters of water (cm H20)||Standard Deviation|Mean
1275392|NCT00311376|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)|||Millimeters (mL) of urine||Standard Deviation|Mean
1275393|NCT00311376|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)|||Number of Weekly Episodes||Standard Deviation|Mean
1275394|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
1275395|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
1275396|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
1275397|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
1275398|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
1275399|NCT00311363|Secondary|Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase)|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 13 had missing data|||points on a scale||Standard Deviation|Mean
1275400|NCT00311363|Secondary|Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 12 had missing data|||hours||Standard Deviation|Mean
1275401|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.|||points on a scale||Standard Deviation|Mean
1275402|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. . The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.|||points on a scale||Standard Deviation|Mean
1275403|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.|||points on a scale||Standard Deviation|Mean
1275404|NCT00311363|Secondary|Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF|The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 3 had missing data.|||participants|||Number
1275405|NCT00311363|Secondary|Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF|The CGI-I scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.|||participants|||Number
1275429|NCT00311311|Secondary|Number of Participants Who Used Lipid Lowering Therapies|"Participants who reported yes for taking lipid lowering therapies as concomitant medication."|From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||participants|||Number
1275406|NCT00311363|Secondary|Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF|The IRLS Rating scale is a measure of disease severity. The scale reflects participant-reported assessment of sensory and motor features and associated sleep problems in RLS. In addition, items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. Total score ranges from 0-40 points, with 40 being the most severe.|Days 1 to 168 (Baseline to Week 24 of SB Phase)|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.|||points on a scale||Standard Deviation|Mean
1275407|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
1275408|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
1275409|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
1275410|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
1275411|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
1275412|NCT00311363|Secondary|Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase)|The 24-hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event; thus, no data are presented for the DB GEn 1200 mg arm.|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||hours||95% Confidence Interval|Median
1286184|NCT00176904|Primary|Overall Survival|Number of patients alive at designated timepoints after transplant.|100 Days, 1 Year and 3 Years||||Participants|||Number
1275413|NCT00311363|Secondary|Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase)|In the 24-hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hr intervals (8 AM to 12 PM, 12 to 4 PM, 4 to 8 PM, 6 to 10 PM, 8 to Midnight, Midnight to 4 AM, 4 to 8 AM)|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population Participants who were missing severity scores for more than two 30-min windows during a 4-hour period had their maximum severity rating for the 4-hour period set to missing. At Randomization (Week 24), there was one participant in each arm with missing 24-hour RLS Record data.|||participants|||Number
1275414|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
1275415|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||hours||Standard Deviation|Mean
1275416|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
1275417|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
1275418|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
1275419|NCT00311363|Secondary|Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response on the participant-rated CGI-I was defined as a rating of very much improved (score of 1) or much improved (score of 2) compared to Baseline of the SB phase."|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||percentage of participants|||Number
1275496|NCT00310804|Secondary|Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.|"To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV."|Day 1 to Day 7 postvaccination|Analysis was done on safety dataset.|||subjects|||Number
1275420|NCT00311363|Secondary|Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse compared to baseline."|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
1275421|NCT00311363|Secondary|Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF|The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
1275422|NCT00311363|Secondary|Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF|The CGI-C scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline. For this endpoint, “response” on the CGI-C was defined as participants with a rating of “no change,” (score of 4) ”minimally improved,” (score of 3) “much improved,” (score of 2) or “very much improved” (score of 1) compared to Randomization (Week 24).|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||percentage of participants|||Number
1275423|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)|The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. LOCF: Missing data (MD) values were imputed using the last non-missing observation prior to the visit with MD; randomization visit data could be carried forward.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
1275424|NCT00311363|Secondary|Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase)|Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.|DB Treatment Period; Days 184 to 252 (Weeks 26 to 36)|DB ITT Population||||||
1275425|NCT00311363|Secondary|Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period|Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.|DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)|DB ITT Population||||||
1275426|NCT00311363|Primary|Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period|"Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 [Week 24] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of much worse or very much worse on the investigator-rated Clinical Global Impression of Change (CGI-C)."|DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||percentage of participants|||Number
1275427|NCT00311311|Secondary|Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant|Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.|Pre-conversion baseline, and 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||mmˆ3/year||Standard Deviation|Mean
1275644|NCT00309907|Secondary|Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy|Pulmonary response is defined as alive & come off of oxygen .|up to day 56|Total of 28 patients are evaluable for this outcome.|||percentage of participants|||Number
1275430|NCT00311311|Secondary|Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant|Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|Two types of folate tests were used: serum folate and red blood cell (RBC) folate. The tests were not consistent across sites. Therefore, the evaluation was not analyzed.||||||
1275431|NCT00311311|Secondary|Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant|Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points|||µmol/L||Standard Deviation|Mean
1275432|NCT00311311|Secondary|Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant|Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points|||pmol/L||Standard Deviation|Mean
1275433|NCT00311311|Secondary|Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant|Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||gram per liter (g/L)||Standard Deviation|Mean
1275434|NCT00311311|Secondary|Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant|Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1275435|NCT00311311|Secondary|Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant|Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||micromole/liter (µmol/L)||Standard Deviation|Mean
1275436|NCT00311311|Secondary|Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant|IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||pg/mL||Standard Deviation|Mean
1275437|NCT00311311|Secondary|Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant|Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||pg/mL||Standard Deviation|Mean
1275438|NCT00311311|Secondary|Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant|TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||pg/mL||Standard Deviation|Mean
1275439|NCT00311311|Secondary|Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.|hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||mg/L||Standard Deviation|Mean
1275440|NCT00311311|Secondary|Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant|Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||microgram per milliliter (µg/mL)||Standard Deviation|Mean
1275441|NCT00311311|Secondary|Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant|HbA1C, change = value at month x post-transplant - pre-conversion baseline.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at the specific time point|||percentage of glucose||Standard Deviation|Mean
1275442|NCT00311311|Secondary|Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant|Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||picomole/liter (pmol/L)||Standard Deviation|Mean
1275443|NCT00311311|Secondary|Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant|Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||mmol/L||Standard Deviation|Mean
1275735|NCT00308581|Secondary|CRP Level at Week 2 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275444|NCT00311311|Secondary|Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant|Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.|Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||millimole/liter (mmol/L)||Standard Deviation|Mean
1275445|NCT00311311|Secondary|Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant|Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.|Pre-conversion baseline, 12, and 24 months post-transplant|Evaluation of carotid plaque roughness at pre-conversion baseline, and at 12 and 24 months post-transplant was planned in the study design, however during the study conduct, it was removed as a cardiovascular endpoint since it was not validated.||||||
1275446|NCT00311311|Secondary|CIMT at Pre-conversion Baseline|Mean CIMT=average of left CIMT and right CIMT.|Pre-conversion baseline|On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline|||mm||Standard Deviation|Mean
1275447|NCT00311311|Secondary|Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant|Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit – CIMT at Conversion Baseline) / Imaging interval in years.|Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||millimeter/year (mm/year)||Standard Deviation|Mean
1275448|NCT00311311|Primary|TPV at Pre-conversion Baseline|TPV is the sum of the assessment in left and right distal common carotid arteries.|Pre-conversion baseline|On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline|||mmˆ3||Standard Deviation|Mean
1275449|NCT00311311|Primary|Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant|Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.|Pre-conversion baseline and 12 months post-transplant|On-Therapy Population: includes all intent-to-treat (ITT) subjects who also remained on assigned therapy until 12 months post-transplant for the primary endpoint, or until 36 months post-transplant for the cardiovascular and safety endpoints; N=number of evaluable participants for the outcome measure at 12 months post-transplant|||millimeter cube/year (mmˆ3/year)||Standard Deviation|Mean
1275450|NCT00311181|Primary|DFT (4.5 ms Waveform)||Implant||||Volts||Standard Error|Mean
1275451|NCT00311181|Primary|DFT (2.5 ms Waveform)||Implant||||Volts||Standard Error|Mean
1275452|NCT00311181|Primary|Defibrillation Thresholds (DFTs) (3.5 ms Waveform)||Implant||||Volts||Standard Error|Mean
1275453|NCT00311155|Secondary|Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment||Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||mm Hg||Standard Deviation|Mean
1275454|NCT00311155|Secondary|Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment||Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||mm Hg||Standard Deviation|Mean
1275455|NCT00311155|Secondary|Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved|Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||Percentage of Participants|||Number
1275456|NCT00311155|Secondary|Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.|Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||Percentage of participants|||Number
1275457|NCT00311155|Secondary|Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved|Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||Percentage of participants|||Number
1275458|NCT00311155|Primary|The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.|For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||Percentage of participants|||Number
1275459|NCT00310856|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination|The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination|From day 1 through day 7 after any vaccination|Analysis was done on the safety population, i.e. all subjects who had at least one vaccination and some postbaseline safety data.|||participants|||Number
1275460|NCT00310856|Secondary|hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1275461|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.|||Percentage of subjects||95% Confidence Interval|Number
1275462|NCT00310856|Secondary|hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1275463|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.|||Percentage of subjects||95% Confidence Interval|Number
1275464|NCT00310856|Secondary|Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age|Before and 1 month after MenC-CRM vaccination at 12 months|Analysis was done on PP population.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1275465|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age|Before and 1 month after MenC-CRM vaccination at 12 months|Analysis was done on PP population.|||Percentage of subjects||95% Confidence Interval|Number
1275466|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on PP population.|||Percentage of subjects||95% Confidence Interval|Number
1275467|NCT00310856|Secondary|Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on PP population.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1275468|NCT00310856|Primary|Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding.|||Percentage of subjects||95% Confidence Interval|Number
1275645|NCT00309907|Secondary|Survival Rate|Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.|Up to day 56|Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.|||percentage of participants||95% Confidence Interval|Number
1275469|NCT00310817|Secondary|Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination|Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician’s visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.|28 days after first vaccination and 21 days after second vaccination|Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.|||Subjects|||Number
1275470|NCT00310817|Secondary|Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.|From day 1 through day 7 after first or second vaccination(s)|Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.|||Subjects|||Number
1275471|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275472|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275473|NCT00310817|Secondary|hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on PP dataset Immunogenicity of a booster dose - subset of subjects in the MITT population who received a booster dose of either MenACWY Ad+/Ad- conjugate vaccine, and provided evaluable serum samples at day 169, 358 & had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
1275474|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275475|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275476|NCT00310817|Secondary|hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|21 days after the second vaccination||||titers||95% Confidence Interval|Geometric Mean
1275477|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275509|NCT00310440|Secondary|Success Rates Measured by Aggregated Modified Odom's Criteria|Subjects selected one of four categories: Excellent (Improvement Greater than or Equal to 80%, Deterioration Less than 10%), Good (Improvement Greater than or Equal to 70%, Deterioration Less than 15%), Fair (Improvement Greater than or Equal to 50%, Deterioration Less than 20%) or Poor (Improvement Less than 50%, Deterioration Greater than 20%).|12 months|Per protocol (PP) subjects that had data available at the 12 month visit were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||participants|||Number
1275478|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+ / Ad- conjugate vaccine who received a booster dose of either Novartis MenACWY Ad+/ Ad- conjugate vaccine, provided evaluable serum samples at day 169 and 358, had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275479|NCT00310817|Secondary|hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
1275480|NCT00310817|Secondary|hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
1275481|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275482|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275483|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275484|NCT00310817|Secondary|hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
1275485|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275486|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after the second vaccination|Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1286185|NCT00176878|Secondary|Number of Patients With Disease Recurrence|Number of patients who exhibited disease recurrence at 2 years.|2 years||||Participants|||Number
1275487|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY–CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-)vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275488|NCT00310817|Secondary|hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
1275489|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subjects in the MITT who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-) or MenACWY-PS vaccine at either 6 or 12 months from the 1st vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the 1st vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275490|NCT00310817|Secondary|Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY(Ad-) vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275491|NCT00310817|Secondary|hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+/PS vaccine, provided evaluable serum samples at day 169 day 358 and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
1275492|NCT00310817|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
1275493|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275494|NCT00310817|Primary|Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
1275495|NCT00310804|Secondary|Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine|Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.|Day 1 - Day 181 postvaccination|This analysis was done on safety dataset.|||subjects|||Number
1275989|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|180 days||||Percentage of participants|||Number
1275497|NCT00310804|Primary|Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine|"Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after~one dose of cTIV for each of the three vaccine lots separately and~one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.~As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination."|Day 22 postvaccination|This analysis was done on PP population.|||Percentages||95% Confidence Interval|Number
1275498|NCT00310804|Primary|Percentage of Subjects With HI Titers ≥40|"Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%."|Day 22 postvaccination|This analysis was done on PP population.|||Percentages||95% Confidence Interval|Number
1275499|NCT00310804|Primary|Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects|"Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5."|Day 22 postvaccination|The analysis was performed as PP dataset.|||Ratio||95% Confidence Interval|Geometric Mean
1275500|NCT00310804|Primary|Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects|"The haemagglutinin Inhibition (HI) antibody titer response following~one dose of cTIV for each of the three lots separately and~one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).~The HI GMTs were evaluated using egg-derived antigen assay."|Day 22 postvaccination|This analysis was done on per protocol (PP) population defined as all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||Titers||95% Confidence Interval|Geometric Mean
1275501|NCT00310791|Primary|Areal Bone Density by DXA||18-Months||||g/cm2||Standard Deviation|Mean
1275502|NCT00310466|Primary|Daily Rhinoconjunctivitis Rescue Medication Score|Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).|Birch pollen season 2006||||Units on a scale (0-30)||Standard Deviation|Mean
1275503|NCT00310466|Secondary|Adverse Events|An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).|Birch pollen season 2006||||Events|||Number
1275504|NCT00310466|Secondary|Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects|The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).|Birch pollen season 2006||||Participants|||Number
1275505|NCT00310466|Primary|Daily Rhinoconjunctivitis Symptom Score|A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.|Birch pollen season 2006||||Units on a scale (0-18)||Standard Deviation|Mean
1275506|NCT00310440|Secondary|Kyphosis|Kyphosis is evaluated in degrees.|12 months|Per protocol (PP) subjects who had images available at 12 months were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||degrees||Standard Deviation|Mean
1275507|NCT00310440|Secondary|Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).|The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score – PCS) and one for mental health (Mental Composite Score – MCS) that are comprised of eight domains. The following domains make up the MCS: vitality, social functioning, role-emotional, mental health. The MCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||score on a scale||95% Confidence Interval|Least Squares Mean
1275508|NCT00310440|Secondary|Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).|The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score – PCS) and one for mental health (Mental Composite Score – MCS) that are comprised of eight domains. The following domains make up the PCS: physical functioning, role-physical, bodily pain, general health. The PCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1275510|NCT00310440|Secondary|Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).|"The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from No pain at all (0) to Worst imaginable pain (10). The change in pain is calculated by subtracting the 12 month score from the baseline score."|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||cm||95% Confidence Interval|Mean
1275511|NCT00310440|Secondary|Mean Change in Pain at Neck Visual Analog Scale (VAS).|"The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from No pain at all (0) to Worst imaginable pain (10). The change in pain is calculated by subtracting the 12 month score from the baseline score."|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||cm||95% Confidence Interval|Mean
1275512|NCT00310440|Primary|Complications|Any AE within 12 months of surgery.|12 months|All enrolled subjects.|||participants|||Number
1275513|NCT00310440|Primary|Neurologic Success|The neurological endpoint is a binary variable. Neurologic success was assessed in the motor, sensory and reflex domains specific for the cervical spine as follows: maintenance or improvement of motor function in the elbow flexors (i.e. biceps muscle), elbow extensors (i.e. triceps muscle) and wrist extensors of both arms; maintenance or improvement of sensory function of both arms; maintenance or improvement of reflexes of both arms as measured at biceps tendon, triceps tendon and brachioradialis (supinator) reflex AND absence of Babinski reflex (if not present prior to surgery). Worsening of neurological status (neurological failure) was defined as a permanent decline in the subject's neurological status based on adjudication of accumulated neurological data by an independent blinded evaluator.|12 months|The total number of observed subjects.|||participants|||Number
1275514|NCT00310440|Primary|Change in of the Overall Neck Disability Index (NDI) Score From Baseline.|The NDI consists of ten items addressing functional activities (personal care, lifting, reading, work, driving, sleeping, recreational activities), pain intensity, concentration and headache. For each item, there are six potential responses, describing increasing degrees of disability (no disability = 0 to total disability = 5). An overall NDI score, out of 100, is calculated by adding up the scores for each item and multiplying by two. A higher NDI score indicates greater disability.|12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1275515|NCT00310440|Primary|Radiologic Fusion|Successful fusion was based on roentgenographic examination showing: evidence of bridging trabecular bone between the involved motion segments, translational motion <3mm, and angular motion <5 degrees. If there was a lack of evidence of fusion on 12 month plain x-ray examination, a CT-scan was performed and final determination of the fusion status was made using the CT reading. The criteria for fusion on CT scans were: trabecular bone formation patterns within the intervertebral disc space and bridging bone formation that crosses the interspace.|12 months|All participants that have radiological data at 12 months including imputed data.|||participants|||Number
1275516|NCT00310427|Primary|Craving for Alcohol Evoked by Alcohol-cue Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 4||||Units on a scale||Standard Error|Mean
1275517|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 3 Rating 2 minus baseline||||Units on a scale||Standard Error|Mean
1275518|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 3 Rating 1 minus baseline||||Units on a scale||Standard Error|Mean
1275519|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 2 Rating 2 minus baseline||||Units on a scale||Standard Error|Mean
1275520|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 2 Rating 1 minus baseline||||Units on a scale||Standard Error|Mean
1275521|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 1 Rating 2 minus baseline||||Units on a scale||Standard Error|Mean
1275522|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 1/Rating 1 minus baseline||||Units on a scale||Standard Error|Mean
1275523|NCT00310427|Primary|Craving for Alcohol (Spontaneous)|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Baseline||||Units on a scale||Standard Error|Mean
1275524|NCT00310401|Secondary|Chest X-ray Findings|Chest radiographs were scored using a radiographic score that scored each quadrant for extent of radiographic infiltrates on a scale of 0 to 4, then summed each quadrant for a total score from 0 (no infiltrates) to 16 (extensive infiltrates in all 4 radiographic quadrants).|change from enrollment to organ procurement (about ~40h after enrollment)||||units on a scale||Standard Deviation|Mean
1275525|NCT00310401|Secondary|Pulmonary Vascular Resistance||72 hours|Insufficient data available to analyze this outcome||||||
1275526|NCT00310401|Secondary|Lung Compliance|Static compliance of the respiratory system using plateau pressure (Pplat) measured at end-inspiration and calculated using the equation static compliance = tidal volume/(Pplat - PEEP)|baseline and at organ procurement (about ~40h after enrollment)||||ml/cmH2O||Standard Deviation|Mean
1275527|NCT00310401|Secondary|Number of Donor Lungs Used for Transplantation|Number of lungs procured and used for transplantation|72 hours||||Participants|||Count of Participants
1275529|NCT00310388|Secondary|Percentage of Seizure Free Days|A seizure free day is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Percentage of seizure free days is calculated as Number of seizure free days / number of applicable days × 100 percent. Only those participants with data available at the indicated time point were analyzed.|Up to 121 months|Safety Population|||Percentage of days||Standard Deviation|Mean
1275530|NCT00310388|Secondary|Number of Participants Who Were Seizure Free for Any 12 Continuous Months|Seizure free for any continuous 12 months is defined as no seizures occurring during any consecutive 360 days. Number of participants who were seizure free for 12 continuous months within the 121 month OLE period have been presented.|Up to 12 continuous months within the 121 months period|Safety Population|||Participants|||Number
1275531|NCT00310388|Secondary|Number of Participants Who Were Seizure Free for Any 6 Continuous Months|Seizure free for any continuous 6 months is defined as no seizures occuring during any consecutive 180 days between the first date (Baseline) and the last date (before tapering of dose). The number of participants who were seizure free for 6 continuous months within the 121 month OLE period have been presented.|Up to 6 continuous months within the 121 months period|Safety Population|||Participants|||Number
1275532|NCT00310388|Secondary|Percentage of Participants With 50% Reduction in Seizure Frequency From Baseline Phase of the Parent Study (VRX-RET-E22-302) to Open Label Treatment|A Responder was defined as a participant with >=50 percent decrease from Baseline in the 28-day partial seizure frequency, i.e., a percent change from Baseline less than or equal to -50 percent. The percentage of responders from Baseline phase of the parent study (VRX-RET-E22-302) to open label treatment have been presented.|Baseline and up to 121 months|Safety Population|||Percentage of participants|||Number
1275533|NCT00310388|Secondary|Percentage Change in the 28-day Partial Seizure Rate From the Baseline Phase (Obtained During the 8-week Baseline Period of Study VRX-RET-E22-302) to Open-label Treatment.|28-day partial seizure rate observed during the OLE period was compared to the 28-day partial seizure rate observed during the Baseline phase of the double-blind parent study VRX-R ET-E22-302. Percent change from Baseline in 28-day total partial seizure rate was calculated as ([28-day partial seizure frequency for the period of interest – Baseline 28-day partial seizure frequency] / Baseline 28-day partial seizure frequency) × 100 percent. A negative percent change indicated a reduction (improvement) from Baseline, so the best possible outcome was -100 percent. Only those participants with data available at the indicated time point were analyzed.|Baseline and up to 121 months|Safety Population|||Percent change||Standard Deviation|Mean
1275534|NCT00310388|Secondary|Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration|Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.|3 years and 10 months|All SFUCP Subjects Population|||Days||Full Range|Median
1275535|NCT00310388|Secondary|Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation|Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.|3 years and 10 months|All SFUCP Subjects Population|||Days||Full Range|Median
1275536|NCT00310388|Secondary|Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine|An assessment of the participant’s nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.|3 years and 10 months|All SFUCP Subjects Population|||Participants|||Count of Participants
1275537|NCT00310388|Secondary|Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine|The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina. Only those participants available at the specified time points were analyzed.|3 years and 10 months|All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase.|||Participants|||Count of Participants
1275538|NCT00310388|Secondary|Percentage of Participants With Decrease in Confrontation Visual Field From Initial Examination|The parameter assessed was decrease in confrontation visual field from initial examination. Only those participants with data available at the indicated time point were analyzed. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.|Up to 121 months|Safety Population|||Percentage of participants|||Number
1275539|NCT00310388|Secondary|Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination|VA refers to the clarity of vision. The parameters assessed were CSD in VA from initial examination which can be explained and CSD in VA from initial examination which cannot be explained. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.|Up to 121 months|Safety Population|||Percentage of participants|||Number
1275668|NCT00309387|Secondary|Number of Participants With a Decrease in Visual Acuity|Number of participants with a decrease in best corrected visual acuity score from baseline of > 15 letters in at least one eligible eye during follow-up|at 6 month intervals from baseline for approximately 10 yrs|intention to treat|||participants|||Number
1275540|NCT00310388|Secondary|Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa|Abnormal discoloration of the skin was determined by a dermatologist. The parameters assessed were abnormal discoloration of the skin, abnormal discoloration of the lips, abnormal discoloration of the nails, abnormal discoloration of the mucosa, abnormal discoloration of sun-exposed tissue, abnormal discoloration of non sun-exposed tissue. Only those participants with at least one skin exam by the investigator or dermatologist on or before the last dose of retigabine or dermatologist-confirmed discoloration with start date on or before the date of last dose of retigabine are presented.|Up to 121 months|Safety Population|||Percentage of participants|||Number
1275541|NCT00310388|Secondary|Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn)|Non-retinal ocular tissue abnormalities were determined by either an ophthalmologist or retina specialist. Non-ret. Pig. Abn is a composite endpoint assessed by its components: abnormal pigmentation (ABP) of the sclera and/or conjunctiva, ABP of the cornea, ABP of the iris and ABP of the lens. Only those participants with >=1 ophthalmology exam on or before last dose of retigabine are presented.|Up to 121 months|Safety Population|||Percentage of participants|||Number
1275542|NCT00310388|Secondary|Percentage of Participants With Retinal Pigmentary Abnormalities (RPA)|RPA was determined by either an ophthalmologist or retina specialist. RPA is the composite endpoint assessed by its components: pigmentary abnormalities (PA) in the macula, PA in the peripheral retina (PR), PA in both macula and PR and PA at location unspecified. Only those participants with >=1 ophthalmology exam on or before last dose of retigabine are presented..|Up to 121 months|Safety Population|||Percentage of participants|||Number
1275543|NCT00310388|Primary|Percentage of Participants With Abnormal Results of Neurological Examination|A complete neurological examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. Abnormal results were categorized as Abnormal-Not Clinically Significant (A-NCS) and Abnormal and Clinically Significant (A-CS). Only data for abnormal values on neurological examination have been presented. Only those participants available at the specified time points were analyzed.|Baseline and up to 122 months|Safety Population|||Percentage of participants|||Number
1275544|NCT00310388|Primary|Percentage of Participants With Abnormal Results of Physical Examination|A complete physical examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. The investigator assessed the skin at every clinic visit. If abnormal skin discoloration was confirmed, the participant continued to be followed by the dermatologist. If the abnormal skin discoloration was not confirmed, the investigator resumed assessing the participants skin at all scheduled clinic visits. Only data for abnormal values on physical examination have been presented. Only those participants available at the specified time points were analyzed.|Baseline and up to 122 months|Safety Population|||Percentage of participants|||Number
1275545|NCT00310388|Primary|Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire|The QOLIE-31-P questionnaire contained 30 items. The subscale scores (seizure worry, overall QOL, emotional well-being, energy-fatigue, cognitive, medication effects, social functioning), the final QOLIE-31-P score and the weighted total score (overall assessment) were calculated according to the scoring algorithm defined by the author. Scores range from 0 to 100 with higher scores indicating better function. Baseline was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Scores on a scale||Standard Deviation|Mean
1275546|NCT00310388|Primary|Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index)|AUA Symptom Index was completed during the first year at Months 1, 3, 12 and at the end of each 12 month study cycle that the participant was enrolled in the Open-Label Treatment Phase (second, third, fourth year) to assess the participant UVF. The questions were scored on a scale of 0 to 5, with 0 (not at all) to 5 (almost always). A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed represented by (n=x).|Baseline and up to 122 months|Safety Population|||Scores on a scale||Standard Deviation|Mean
1275547|NCT00310388|Primary|Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume|The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically. A PVR bladder ultrasound to assess urinary retention was performed during the first year at Months 1, 3 and 12 and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.) in the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Milliliters||Standard Deviation|Mean
1275564|NCT00310388|Primary|Number of Participants With TEAEs Leading to Treatment Discontinuation (Disc.)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of participants with treatment emergent AEs leading to treatment disc. up to 122 months have been presented.|Up to 122 months|Safety Population|||Participants|||Number
1275548|NCT00310388|Primary|Change From Baseline in Urine Potential of Hydrogen (pH)|Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Points on a scale||Standard Deviation|Mean
1275549|NCT00310388|Primary|Change From Baseline in Urine Specific Gravity|Urine specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Ratio||Standard Deviation|Mean
1275550|NCT00310388|Primary|Change From Baseline in Hematology Parameter Red Blood Cells (RBC)|The hematology parameters included RBC. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||10^12 cells per liter||Standard Deviation|Mean
1275551|NCT00310388|Primary|Change From Baseline in Hemoglobin|The hematology parameters included hemoglobin. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Grams per liter||Standard Deviation|Mean
1275552|NCT00310388|Primary|Change From Baseline in Hematocrit|Blood samples for the assessment of clinical laboratory parameter hematocrit were collected at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Percentage of red blood cells in blood||Standard Deviation|Mean
1275553|NCT00310388|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC)|Hematology parameters included eosinophils, basophils lymphocytes, monocytes, neutrophils, platelet count , and WBC. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||10^9 cells per Liter||Standard Deviation|Mean
1275554|NCT00310388|Primary|Change From Baseline in Total Protein|Clinical chemistry parameter included total protein. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Grams per liter||Standard Deviation|Mean
1275555|NCT00310388|Primary|Change From Baseline in Creatinine, Total Bilirubin and Uric Acid|Clinical chemistry parameters included creatinine, total bilirubin and uric acid. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Micromoles per liter||Standard Deviation|Mean
1275586|NCT00310375|Primary|Change From Baseline in Urine Specific Gravity|Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Dimensionless unit||Standard Deviation|Mean
1275556|NCT00310388|Primary|Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea|Clinical chemistry parameters included bicarbonate, calcium, chloride, cholesterol, Non-fasting Glucose, phosphorus, potassium, sodium and urea. Approximately 7-milliliter sample of blood was drawn for clinical chemistry assays. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Millimoles per liter||Standard Deviation|Mean
1275557|NCT00310388|Primary|Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST)|Clinical chemistry parameters included Alk. Phos., ALT and AST. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||International units per liter||Standard Deviation|Mean
1275558|NCT00310388|Primary|Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia|A 12-lead ECG was performed at all study visits during the Open-Label Treatment Phase during the first year of the open-label extension study (Months 1, 3, 6, 9, 12) and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.). The ECG parameters that were assessed were PR interval, QRS interval, QRS duration, QT interval, and QTc interval. QT intervals were corrected using both Bazett’s and Friedericia’s formulas. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Milliseconds||Standard Deviation|Mean
1275559|NCT00310388|Primary|Change From Baseline in Body Weight|Weight in pounds or kilograms was measured in ordinary indoor clothing (without shoes) and was recorded at all study visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Kilograms||Standard Deviation|Mean
1275560|NCT00310388|Primary|Change From Baseline in Body Temperature|Vital sign measurement temperature was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Degree Celsius||Standard Deviation|Mean
1275561|NCT00310388|Primary|Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position|Vital sign measurement HR was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of HR was performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Beats per minute||Standard Deviation|Mean
1275562|NCT00310388|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position|Vital sign measurements (supine and standing blood pressure ) were obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of blood pressure were performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
1275563|NCT00310388|Primary|Kaplan-Meier Estimate of the Probability of Disc. From Study Drug|Kaplan-Meier estimate of the probability of disc. at the specified time for all participants is presented. The time frame of premature study disc. was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who had a taper dose start date, the time of withdrawal was the day before the start of taper dose. Participants who switched to commercial product were censored at the last dose of study drug (excluding taper). All participants who withdrew from the study/treatment prematurely but did not switch to commercial product were counted as an event. Number of participants continuing on retigabine at each time of withdrawal were analyzed (represented by n=x in the category titles).|Up to 122 months|Safety Population|||Percentage Probability of disc.|||Number
1275565|NCT00310388|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with impaired liver function. TEAEs refer to an AE for which the onset was on or after Retigabine dose in this study and on or before 30 days after the last Retigabine dose date. AEs that started in the parent study that worsened in this study were also considered as TEAEs. Analysis was performed on the safety population which included participants who took at least 1 dose of study medication after being enrolled in this OLE study.|Up to 122 months|Safety Population|||Participants|||Number
1275566|NCT00310375|Secondary|Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire|The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Assessed up to a maximum of 9 years|Safety Population|||Scores on a scale||Standard Deviation|Mean
1275567|NCT00310375|Secondary|Percentage of Seizure-free Days|Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days|Assessed up to a maximum of 9 years|Safety Population|||Percentage of days||Standard Deviation|Mean
1275568|NCT00310375|Secondary|Number of Participants Who Were Seizure Free for Any 12 Continuous Months|Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
1275569|NCT00310375|Secondary|Number of Participants Who Were Seizure Free for Any 6 Continuous Months|Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
1275570|NCT00310375|Secondary|Number of Responders|A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
1275571|NCT00310375|Secondary|Percentage Change From Baseline in the 28-day Partial Seizure|Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Percent change||Standard Deviation|Mean
1275572|NCT00310375|Primary|Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration|Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.|2 years 9 months|All SFUCP Subjects Population|||Days||Full Range|Median
1275573|NCT00310375|Primary|Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation|Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.|2 years 9 months|All SFUCP Subjects Population|||Days||Full Range|Median
1275574|NCT00310375|Primary|Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine|An assessment of the participant’s nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.|2 years 9 months|All SFUCP Subjects Population|||Participants|||Number
1275587|NCT00310375|Primary|Change From Baseline in Chemistry Parameter-Total Protein|Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population|||Grams per liter (g/L)||Standard Deviation|Mean
1275575|NCT00310375|Primary|Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine|The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.|2 years and 9 months|All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase.|||Participants|||Number
1275576|NCT00310375|Primary|Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination|Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
1275577|NCT00310375|Primary|Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination|A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
1275578|NCT00310375|Primary|Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa|An assessment of the participant’s nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
1275579|NCT00310375|Primary|Number of Participants With Pigmentation of Retinal Ocular Tissue|The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
1275580|NCT00310375|Primary|Number of Participants With Pigmentation of Non-retinal Ocular Tissue|The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
1275581|NCT00310375|Primary|Number of Participants With Abnormal Results of Neurological Examination|Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Up to Month 108|Safety Population|||Participants|||Number
1275582|NCT00310375|Primary|Number of Participants With Abnormal Results in Physical Examination|A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category|Up to Month 108|Safety Population|||Participants|||Number
1275583|NCT00310375|Primary|Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score|An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant’s urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population|||Scores on a scale||Standard Deviation|Mean
1275584|NCT00310375|Primary|Change From Baseline in Post-void Residual Bladder Ultrasound Volume|Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population|||Milliliter (mL)||Standard Deviation|Mean
1275585|NCT00310375|Primary|Change From Baseline in Urine Power of Hydrogen (pH)|Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||pH units||Standard Deviation|Mean
1275625|NCT00310050|Secondary|Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy|Toxicity will be determined using the revised NCI Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Number of events with grade 1-5 will be reported.|42 days|Data available for 2 participants.|||events|||Number
1275588|NCT00310375|Primary|Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA)|Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Micromole per Liter (umol/L)||Standard Deviation|Mean
1275589|NCT00310375|Primary|Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea|Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Millimole per liter (mmol/L)||Standard Deviation|Mean
1275590|NCT00310375|Primary|Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)|Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||International units per litre (IU/L)||Standard Deviation|Mean
1275591|NCT00310375|Primary|Change From Baseline in Haemoglobin|Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..|Baseline and Up to Month 108|Safety Population|||Grams/Liter (g/L)||Standard Deviation|Mean
1275592|NCT00310375|Primary|Change From Baseline in Haematocrit|Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population|||Volume/Volume (v/v)||Standard Deviation|Mean
1275593|NCT00310375|Primary|Change From Baseline in Hematology Parameter-Red Blood Cell Count|Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..|Baseline and Up to Month 108|Safety Population|||10^12 cells/Liter(L)||Standard Deviation|Mean
1275594|NCT00310375|Primary|Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC)|Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||10^9 cells/Liter||Standard Deviation|Mean
1275595|NCT00310375|Primary|Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population|||Degree||Standard Deviation|Mean
1275596|NCT00310375|Primary|Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population|||Seconds (sec)||Standard Deviation|Mean
1275626|NCT00310050|Primary|Quantitative Toxicity of Pemetrexed When Administered With Concomitant Radiation Therapy||42 days|data were not collected||||||
1275627|NCT00310050|Primary|Determine Maximum Tolerated Dose of Pemetrexed When Administered With Concomitant Radiation Therapy||42 days|data were not collected||||||
1275597|NCT00310375|Primary|Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF)|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Milliseconds (msec)||Standard Deviation|Mean
1275598|NCT00310375|Primary|Change From Baseline in Weight|Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Kilograms||Standard Deviation|Mean
1275599|NCT00310375|Primary|Change From Baseline in Body Temperature|Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available|Baseline and Up to Month 108|Safety Population|||Degree Celsius||Standard Deviation|Mean
1275600|NCT00310375|Primary|Change From Baseline in Heart Rate|Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Beats per Minute||Standard Deviation|Mean
1275601|NCT00310375|Primary|Change From Baseline in Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1275602|NCT00310375|Primary|Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug|The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn’t switch to commercial product were counted as “events”. Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title).|Assessed up to a maximum of 9 years|Safety Population|||Percentage Probability of d/c|||Number
1275603|NCT00310375|Primary|Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug|Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.|Assessed up to a maximum of 9 years|Safety Population|||Participants.|||Number
1275604|NCT00310375|Primary|Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.|Assessed up to a maximum of 9 years|Safety Population included all participants who took at least 1 dose of study medication|||Participants|||Number
1275605|NCT00310362|Secondary|Preparation Non-adherence-flexible Sigmoidoscopy|Preparation nonadherence assessed whether patients had adequately prepared to complete the flexible sigmoidoscopy procedure.|3 months|||||||
1275606|NCT00310362|Secondary|Preparation Nonadherence-colonoscopy|Preparation nonadherence assessed whether patients had adequately prepared to complete the colonoscopy procedure.|3 months|||||||
1275607|NCT00310362|Secondary|Nonattendance-flexible Sigmoidoscopy|Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment|3 months|||||||
1275608|NCT00310362|Primary|Appointment Nonadherence-colonoscopy|Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment|3 months||||nonadherent participants|||Number
1275609|NCT00310310|Other Pre-specified|Epworth Sleepiness Scale (ESS)|ESS is a widely used subjective measure of excessive daytime sleepiness in research and clinical settings. Participants are asked to indicate how likely they would be to fall asleep in eight different situations on a scale from 0 (not likely) to 3 (highly likely). The situations are designed to vary in sleep-inducing capacity. The ESS scoring range is 0–24, with higher scores reflecting greater daytime sleepiness.|1 month|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.|||units on a scale||Standard Deviation|Mean
1275610|NCT00310310|Other Pre-specified|Center for Epidemiological Studies - Depression Scale (Short Form)|"The CES-D is a 10-item self-report measure of depression. The 10-item version has adequate predictive accuracy when compared to the original full-length 20-item version, as well as adequate test-retest correlations and discriminative validity.~The total score is calculated by finding the sum of 10 items. Any score equal to or above 10 is considered depressed."|1 month||||units on a scale||Standard Deviation|Mean
1275611|NCT00310310|Other Pre-specified|Outcome Expectation|"Social-cognitive theory (SCT) measure~1= Not at all important 5= Extremely important 6= Not applicable"|1 month||||units on a scale||Standard Deviation|Mean
1275612|NCT00310310|Other Pre-specified|Self-Efficacy|"Social-cognitive theory (SCT) measure~1= Disagree Completely 5= Agree Completely 6= Not applicable"|1 month||||units on a scale||Standard Deviation|Mean
1275613|NCT00310310|Other Pre-specified|Quality of Well Being Scale (QWB-SA)|The QWB-SA is a generic, preference-based measure that produces a single score appropriate for cost-effectiveness estimates and has been used in veteran and other general adult populations. The advantage of having a single, scaled score instead of multiple separate subscale domains is important for comparing interventions. The QWB-SA is a comprehensive measure of health-related quality of life that consists of 78-items and five sections: (I) acute and chronic symptoms; (II) self-care activities; (III) mobility; (IV) physical activity and performance of physical functioning; and (V) social activity. The level of functioning and the subjective symptom reports are then weighted by preference, or utility, on a scale that ranges from 0 (dead) to 1.0 (optimum function).|1 month||||units on a scale||Standard Deviation|Mean
1275614|NCT00310310|Other Pre-specified|Sleep Apnea Quality of Life Index (SAQLI)|"Sleep Apnea Quality of Life Index (SAQLI) which is a 35-item clinician-administered scale composed of five domains: daily functioning, social interactions, emotional functioning, symptoms, and CPAP side effects. . It has high internal consistency, strong content and construct validity, and adequate concurrent and discriminative validity, and is responsive to changes in HRQOL. The key advantages to inclusion of the SAQLI is that it is the only clinician-administered scale in the study and it contains a CPAP side effect scale that is one of the few valid measures of the frequency and amount of CPAP side effects.~A very large, All the time~A large~A moderate to large~A moderate~A small to moderate~A small~No, None, Not at all"|1 month||||units on a scale||Standard Deviation|Mean
1275615|NCT00310310|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach’s alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%).~In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|6 Months|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities. We had a few Veterans who skipped this assessment when filling out the project assessment packet.|||units on a scale||Standard Deviation|Mean
1275616|NCT00310310|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach’s alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%).~In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|1 Month|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.|||units on a scale||Standard Deviation|Mean
1275617|NCT00310310|Primary|CPAP Adherence|The investigators also examined the data obtained at the 6-month time point.|6 months||||hours per night||Standard Deviation|Mean
1275618|NCT00310310|Primary|CPAP Adherence|The investigators examined the data obtained in the Sleep Apnea Self-Management Program at the one-month time point relative to participation in the Usual Care group.|1 month||||hours per night||Standard Deviation|Mean
1275619|NCT00310076|Secondary|Number of Events of Toxicity Graded 3 and 4|Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported|up to 60 months||||number of events|||Number
1275620|NCT00310076|Secondary|Progression Free Survival||60 months after treatment||||years||95% Confidence Interval|Median
1275621|NCT00310076|Primary|Time to Progression|Time to progression after surgery was recorded.|9 hours||||years||95% Confidence Interval|Median
1275622|NCT00310050|Secondary|Number of Participants That Survived||1 year||||Participants|||Count of Participants
1275623|NCT00310050|Secondary|Patterns of Response||1 year|Data not collected on all participants.|||Participants|||Count of Participants
1275624|NCT00310050|Secondary|Patterns of Failure||1 year|Data not collected.||||||
1275629|NCT00310037|Secondary|Number of Participants With Complete Response Intensive Chemo-immunotherapy Plus Maintenance or Consolidation Bortezomib|"Complete response is:~Complete disappearance of all detectable clinical and radiographic evidence of target lesions and disappearance of all disease-related symptoms if present prior to therapy and normalization of biochemical abnormalities definitely assignable to NHL~All lymph nodes and nodal masses must have regressed to normal size (<= 1.5 cm in the greatest transverse diameter (GTD) for nodes > 1.5 cm prior to therapy) or <= 1 cm for nodes that were 1.1-1.5 cm in the GTD prior to therapy or by more than 75% in the sum of the products of the GTD~The spleen, if enlarged before therapy, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging studies should no longer be present. Other organs enlarged prior to therapy due to involvement of lymphoma must have decreased in size~If bone marrow was involved by lymphoma prior to treatment, infiltrate must be cleared on repeat bone marrow aspirate"|Up to 10 years||||participants|||Number
1275630|NCT00310037|Secondary|Overall Survival|Overall Survival (OS) was measured from the date of study entry to date of death due to any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years||||years||95% Confidence Interval|Median
1275631|NCT00310037|Primary|Progression-free Survival Rate at 18 Months|Progression free survival (PFS) rate at 18 months was defined as the proportion of patients that were alive and progression-free 18 months after registration into the study. The Kaplan-Meier method of 18 month progression-free survival was calculated..|At 18 months||||percentage of participants||95% Confidence Interval|Number
1275632|NCT00309985|Secondary|QOL Change From Baseline to 3 Months|The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy – Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.|Assessed at baseline and 3 months|Patients with both baseline and 3-month QOL assessments are included in this analysis.|||units on a scale||Standard Error|Mean
1275633|NCT00309985|Secondary|Proportion of Patients With PSA Complete Response (CR) at 12 Months|PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.|Assessed at 12 months|All randomized patients|||proportion of participants||95% Confidence Interval|Number
1275634|NCT00309985|Secondary|Proportion of Patients With PSA Complete Response (CR) at 6 Months|PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.|Assessed at 6 months|All randomized patients|||proportion of participants||95% Confidence Interval|Number
1275635|NCT00309985|Secondary|Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)|Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients.|||months||95% Confidence Interval|Median
1275636|NCT00309985|Secondary|Time to Clinical Progression|Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients.|||months||95% Confidence Interval|Median
1275637|NCT00309985|Primary|Overall Survival|Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients|||months||95% Confidence Interval|Median
1275638|NCT00309946|Secondary|Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity|Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.|Week 1 of course 1|This outcome was not measured/assessed for any of the study subjects.||||||
1275639|NCT00309946|Secondary|Changes in Laboratory Correlates|Examined using paired t-test or Wilcoxon signed-ranks test.|Baseline, days 15 and 29 of course 1, and then every 28 days|This outcome was not measured/assessed for any of the study subjects.||||||
1275640|NCT00309946|Primary|Objective Response Rate, Complete (CR) or Partial (PR) Response|Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.|Every 8 weeks||||percentage of participants|||Number
1275641|NCT00309907|Secondary|C-reactive Protein Levels|Estimated mean and standard deviation|From baseline to days 7, 14, 21, and 28|The data for baseline were intended to be analyzed for all subjects, therefore, combined result is reported. The data for Days 7, 14, 21 and 28 were intended to be analyzed by subgroups of subjects as pre-specified in the study protocol, therefore combined result us not reported for Etanercept + corticosteroid therapy treatment arm.|||mg/dL||Standard Deviation|Mean
1275646|NCT00309907|Primary|Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.|Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for > 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.|At day 28|Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.|||participants|||Number
1275647|NCT00309777|Secondary|National Cholesterol Education Program (NCEP) LDL-C Target Attainment|Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12|12 week|Full Analysis Set|||Participants|||Number
1275648|NCT00309777|Primary|Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks|Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks|Baseline to 12 weeks||||Percent change||Standard Deviation|Mean
1275649|NCT00309751|Secondary|Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target|Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks|12 weeks||||Participants|||Number
1275650|NCT00309751|Primary|Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)|Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)|12 weeks||||percent change||Standard Deviation|Mean
1275651|NCT00309738|Secondary|Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)|Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)|12 weeks|Full analysis set (FAS)|||participants|||Number
1275652|NCT00309738|Primary|Percent Change From Baseline in LDL-C|Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)|12 weeks|Subjects who completed the treatment period|||mg/dL||Standard Deviation|Mean
1275653|NCT00309608|Secondary|Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1275654|NCT00309608|Secondary|Percentage of Patients With HbA1c<=7.0% at Week 12|Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.|week 12|This population includes the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used as the imputation rule.|||Percentage of Patients|||Number
1275655|NCT00309608|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1275656|NCT00309465|Primary|Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery|Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.|Day 1|Percentage of subjects that achieved preoperative blood glucose value of 100-179 mg/dl and 80-249 mg/dl. Analyses were by intention to treat.|||Percentage of subjects|||Number
1275657|NCT00309452|Secondary|Economic Measures Including Service Use, Cost of Care and Forensic Data.|Total annual cost per patient|every 6 months||||dollars||Standard Error|Mean
1275658|NCT00309452|Secondary|Medication (Including Metabolic) Side Effects||every 6 months|data no collected||||||
1275659|NCT00309452|Secondary|Subjects Who Committed Self-harm and Violence|The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.|12 months|This data was collected, numbers reflect actual data.|||participants|||Number
1275660|NCT00309452|Secondary|Substance Use||every 6 months|This was not a planned primary or secondary outcome in our analysis (though collected at baseline) and because of significant attrition we did not report on this outcome despite having phone call f/u data on other outcomes. We did not believe phone reports on this outcome would produce reliable data.||||||
1275661|NCT00309452|Secondary|Adherence- in Contact With Mental Health Services|Number of participants in contact with mental health services. Collected via self-report.|1 year|Patients were lost to follow up. 15 subjects in the Treatment as Usual arm, and 15 subjects in the STEP care arm.|||participants|||Number
1275662|NCT00309452|Secondary|Treatment Satisfaction||every 6 months|Data was not collected||||||
1275663|NCT00309452|Secondary|Vocationally Engaged||1 year after enrollment|20 subjects from the treatment as usual arm were lost to follow-up. 12 subjects from STEP Care arm were lost to follow up.|||participants|||Number
1275664|NCT00309452|Secondary|Quality of Life- Heinrich's Quality of Life Scale|"The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126.~The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health."|12 months||||units on a scale||Standard Deviation|Mean
1275665|NCT00309452|Secondary|Overall Functioning- Global Assessment of Functioning|"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning.~The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning."|12 months||||units on a scale||Standard Deviation|Mean
1275666|NCT00309452|Secondary|Relapse|Data was not collected, instead Hospitalization (primary outcome) was used as a proxy|every 6 months|||||||
1275667|NCT00309452|Primary|Number of Patients Hospitalized||1 year after enrollment||||participants|||Number
1275670|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities|Number of participants with a 5% increase in area of posterior subcapsular opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat|||participants|||Number
1275671|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Cortical Lens Opacities|Number of participants with a 10% increase in area of cortical opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat|||participants|||Number
1275672|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Nuclear Lens Opacities|number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat|||participants|||Number
1275673|NCT00309387|Primary|Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up|number of participants in whom any of the following occur in at least one eligible eye during follow-up: cataract surgery; nuclear opacity: a 1.5 U increase in opalescence from baseline; cortical opacity: a 10% increase in area within a standard 5 mm circle area of the lens from baseline; posterior subcapsular opacity: a 5% increase in area within a standard 5 mm circle area of the lens from baseline.|at yearly intervals from baseline for approximately ten years|Intention to treat analysis|||participants|||Number
1275674|NCT00309244|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|52 Weeks|Safety Population|||Number of events/100 subject-months|||Number
1275675|NCT00309244|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|52 Weeks|Safety Population|||Number of events/subject-month|||Number
1275676|NCT00309244|Secondary|Incidence of Severe Hypoglycemia|"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:~Subject requires the assistance of another person;~Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);~Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,~Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms."|52 Weeks|Safety Population|||percentage of participants|||Number
1275677|NCT00309244|Secondary|Incidence of Total Hypoglycemia|Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.|52 Weeks|Safety Population|||percentage of participants|||Number
1275678|NCT00309244|Secondary|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%||Week 52|Intention to treat (ITT); participants with available data at baseline and Week 52.|||participants|||Number
1275679|NCT00309244|Secondary|Change From Baseline in Fasting Plasma Glucose to Week 52||Baseline to Week 52|Intention to treat (ITT) population; participants with available data at baseline and Week 52.|||milligrams per deciliter||Standard Error|Least Squares Mean
1275680|NCT00309244|Secondary|Change From Baseline in Weight to Week 52||Baseline to Week 52|Intention to treat (ITT) population; participants with available data at baseline and Week 52.|||kilogram||Standard Error|Least Squares Mean
1275681|NCT00309244|Primary|Change From Baseline in HbA1c to Week 52||Baseline to Week 52|Intention to treat (ITT) with Last Observation Carried Forward (LOCF); participants with available data at baseline and post-baseline.|||percent||Standard Error|Least Squares Mean
1275682|NCT00309166|Secondary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.|At Month 2 and at Month 7, post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1275683|NCT00309166|Secondary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: alanine aminotransferase [ALT], basophils [BAS], creatinine [CREA], eosinophils [EOS] and hematocrit [Hem]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.|At Month 2 and Month 7, post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1275684|NCT00309166|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available up to Month 7 and on the Extended Safety Follow-Up (ESFU) Total Vaccinated cohort, which included all vaccinated subjects that could be contacted by telephone for the Safety follow-up at Month 12.|||Participants|||Count of Participants
1275685|NCT00309166|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions|NOCDs include asthma, Chron`s disease, dermatitis atopic. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.|Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available up to Month 7 and on the Extended Safety Follow-Up (ESFU) Total Vaccinated cohort, which included all vaccinated subjects that could be contacted by telephone for the Safety follow-up at Month 12.|||Participants|||Count of Participants
1275686|NCT00309166|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Day 0-29) after any vaccination, up to 7 months|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1275687|NCT00309166|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, fever (defined as axillary temperature ≥37.5 °C), gastrointestinal, headache, myalgia, rash and urticaria. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature > 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination.|Within 7 days (Days 0-6) after each dose and across doses, up to 7 months|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheets.|||Participants|||Count of Participants
1275688|NCT00309166|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling spreading beyond (>) 50 mm.|Within 7 days (Days 0-6) after each dose and across doses, up to 7 months|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Participants|||Count of Participants
1275689|NCT00309166|Secondary|Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)|Titers were presented as GMTs.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1275690|NCT00309166|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||Participants|||Count of Participants
1275691|NCT00309166|Primary|Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)|Titers were presented as geometric mean titers (GMT).|At Month 7|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1275692|NCT00309166|Primary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL] in the serum of subjects seronegative before vaccination.|At Month 7|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||Participants|||Count of Participants
1275693|NCT00308997|Secondary|Clinical Global Improvement (CGI)Improvement|"CGI score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The range for this score is from 1 to 7.~Lower scores correspond to greater improvement"|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1275694|NCT00308997|Secondary|Change in Total Auditory Hall Rating Scale (AHRS) Score|"Total AHRS score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The score range is from 0-42. This is reported as a difference score and a higher score is an improvement.~Total AHRS score is measured as change relative baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement."|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1275695|NCT00308997|Secondary|Change in Hallucination Frequency|"AHRS frequency scale score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The hallucination frequency range is from 0-9. The scores reported are difference scores, and an improvement is a higher score.~Hallucination frequency is one of the variables incorporated into the AHRS (Auditory Hallucinations Rating Scale). The score is measured as change relative to baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement."|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1275696|NCT00308997|Primary|Hallucination Change Score (HCS)|"HCS score assessed after 15 sessions, 16 minutes per session, delivered to both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation. For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1275697|NCT00308997|Primary|Hallucination Change Score - Left (HCS-left)|"HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the left superior temporal gyrus.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 5 sessions of rTMS|Subjects who did not complete the intervention were not included in the analysis|||units on a scale||Standard Deviation|Mean
1275698|NCT00308997|Primary|Hallucination Change Score - Right (HCS-right)|"HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the right superior temporal gyrus.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 5 sessions of rTMS|Subjects who did not complete the intervention were not analyzed|||units on a scale||Standard Deviation|Mean
1275699|NCT00308737|Primary|FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care|FEV1 decrease of ≥ 15% from Baseline value at last measurement|Baseline to Month 24|Intention to Treat (ITT)|||Participants|||Number
1275700|NCT00308737|Secondary|Change in Weight From Baseline at Month 24|Change from baseline in weight at Month 24|Baseline to Month 24|Safety population at Month 24|||kilograms||Standard Deviation|Mean
1275701|NCT00308737|Secondary|Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care|Change from baseline in HbA1c at last measurement|Baseline to Month 24|Intention to treat (ITT) with last observation carried forward (LOCF)|||percentage||Standard Deviation|Mean
1275702|NCT00308737|Secondary|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement|Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement|Baseline to Month 24|participants in ITT population with available data|||Participants|||Number
1275703|NCT00308737|Secondary|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement|Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement|Baseline to Month 24|participants in ITT population with available data|||Participants|||Number
1275704|NCT00308737|Secondary|Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement|TLC Decrease of ≥ 15% from Baseline Value at Last Measurement|Baseline to Month 24|participants in ITT population with available data|||Participants|||Number
1275705|NCT00308737|Secondary|Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement|FVC Decrease of ≥15% from Baseline Value at Last Measurement|Baseline to Month 24|participants in ITT population with available data|||participants|||Number
1275706|NCT00308737|Secondary|Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM|Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM|Baseline to Month 24|participants in ITT population with available data|||mL/min/mmHg||Standard Deviation|Mean
1275707|NCT00308737|Secondary|Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM|Change from baseline to Month 24 in TLC by MMRM|Baseline to Month 24|participants in ITT population with available data|||liters||Standard Deviation|Mean
1275708|NCT00308737|Secondary|Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM|Change from Baseline to Month 24 in FVC by MMRM|Baseline to Month 24|Intention to Treat (ITT)|||liters||Standard Deviation|Mean
1275709|NCT00308737|Secondary|Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care|Change from Baseline to last measurement(Month 24) in FEV1|Baseline to Month 24|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||liters||95% Confidence Interval|Least Squares Mean
1275710|NCT00308737|Primary|Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care|Change from Baseline to End of Study in FEV1 by MMRM|Baseline to Month 24|Intention to Treat (ITT)|||liters||Standard Deviation|Mean
1275711|NCT00308711|Secondary|Days in Hospital for Mother and Neonate|Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.|10 days||||days||Standard Deviation|Mean
1275712|NCT00308711|Secondary|Duration of Stay in Minutes in Labor and Delivery Suite|Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care.|5760 minuts||||minutes||Standard Deviation|Mean
1275713|NCT00308711|Secondary|Minutes to Rupture of Membranes (ROM)|Interval from study drug insertion to ROM.|2880 minutes||||minutes||95% Confidence Interval|Median
1275714|NCT00308711|Secondary|Minutes to Onset of Active Labor|Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.|2880 minutes||||minutes||Standard Deviation|Mean
1275715|NCT00308711|Secondary|Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert|Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.|12 hours||||Percentage of Participants|||Number
1275716|NCT00308711|Secondary|Percentage of Participants With Pre-Delivery Oxytocin Use|Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.|2880 minutes|This analysis included all participants exposed to study drug and for whom there was data available regarding whether oxytocin was used pre-delivery.|||Percentage of participants|||Number
1275736|NCT00308581|Secondary|C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 0|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275717|NCT00308711|Secondary|Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events|"This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the Maternal/Fetal period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods."|96 hours|Analysis was based on intention to treat, i.e., all subjects who had the insert placed in the vagina.|||Percentage of participants|||Number
1275718|NCT00308711|Primary|Percentage of Participants With a Cesarean Section Delivery|Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.|2880 minutes||||Percentage of participants|||Number
1275719|NCT00308711|Primary|Minutes From Drug Insertion to Vaginal Delivery|Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.|2880 minutes|This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate.|||minutes||95% Confidence Interval|Median
1275720|NCT00308620|Secondary|Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks|The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.|8 weeks|Analysis of Chloroquine arms is pooled.|||percentage change||Full Range|Median
1275721|NCT00308620|Primary|HIV Viral Load Change|HIV-1 viral load change between baseline and 8 weeks|baseline and 8 weeks||||log10 copies/mL||Standard Deviation|Log Mean
1275722|NCT00308581|Secondary|CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.|Last visit on or before Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275723|NCT00308581|Secondary|CRP Level at Week 26 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275724|NCT00308581|Secondary|CRP Level at Week 24 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275725|NCT00308581|Secondary|CRP Level at Week 22 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 22 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)|||mg/L||Inter-Quartile Range|Median
1275726|NCT00308581|Secondary|CRP Level at Week 20 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275727|NCT00308581|Secondary|CRP Level at Week 18 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 18 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)|||mg/L||Inter-Quartile Range|Median
1275728|NCT00308581|Secondary|CRP Level at Week 16 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275729|NCT00308581|Secondary|CRP Level at Week 14 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 14 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)|||mg/L||Inter-Quartile Range|Median
1275730|NCT00308581|Secondary|CRP Level at Week 12 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275731|NCT00308581|Secondary|CRP Level at Week 10 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 10 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)|||mg/L||Inter-Quartile Range|Median
1275732|NCT00308581|Secondary|CRP Level at Week 8 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275733|NCT00308581|Secondary|CRP Level at Week 6 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275734|NCT00308581|Secondary|CRP Level at Week 4 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||mg/L||Inter-Quartile Range|Median
1275737|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 26|ITTR population taking steroids at baseline|||participants|||Number
1275738|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 24|ITTR population taking steroids at baseline|||participants|||Number
1275739|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 22|ITTR population taking steroids at baseline|||participants|||Number
1275740|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 20|ITTR population taking steroids at baseline|||participants|||Number
1275741|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 18|ITTR population taking steroids at baseline|||participants|||Number
1275742|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 16|ITTR population taking steroids at baseline|||participants|||Number
1275743|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 14|ITTR population taking steroids at baseline|||participants|||Number
1275744|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 12|ITTR population taking steroids at baseline|||participants|||Number
1275745|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 10|ITTR population taking steroids at baseline|||participants|||Number
1275746|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 26|ITTR population taking steroids at baseline|||participants|||Number
1275747|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 24|ITTR population taking steroids at baseline|||participants|||Number
1275748|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 22|ITTR population taking steroids at baseline|||participants|||Number
1275749|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 20|ITTR population taking steroids at baseline|||participants|||Number
1275750|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 18|ITTR population taking steroids at baseline|||participants|||Number
1275751|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 16|ITTR population taking steroids at baseline|||participants|||Number
1275752|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 14|ITTR population taking steroids at baseline|||participants|||Number
1275753|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 12|ITTR population taking steroids at baseline|||participants|||Number
1275754|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 10|ITTR population taking steroids at baseline|||participants|||Number
1275755|NCT00308581|Other Pre-specified|Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6|Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.|Week 6 to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||days||Full Range|Median
1275756|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275757|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275758|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 22|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275759|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275760|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 18|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275761|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275762|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 14|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275763|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275764|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 10|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275765|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275766|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 6 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275767|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 4 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275768|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 2 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275769|NCT00308581|Secondary|CDAI Score at Week 26 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275770|NCT00308581|Secondary|CDAI Score at Week 24 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275771|NCT00308581|Secondary|CDAI Score at Week 22 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 22|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275772|NCT00308581|Secondary|CDAI Score at Week 20 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275773|NCT00308581|Secondary|CDAI Score at Week 18 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 18|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275774|NCT00308581|Secondary|CDAI Score at Week 16 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275775|NCT00308581|Secondary|CDAI Score at Week 14 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 14|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275776|NCT00308581|Secondary|CDAI Score at Week 12 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275777|NCT00308581|Secondary|CDAI Score at Week 10 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 10|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275778|NCT00308581|Secondary|CDAI Score at Week 8 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275779|NCT00308581|Secondary|CDAI Score at Week 6 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275780|NCT00308581|Secondary|CDAI Score at Week 4 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275781|NCT00308581|Secondary|CDAI Score at Week 2 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
1275782|NCT00308581|Secondary|Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase|Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase|||participants|||Number
1275783|NCT00308581|Secondary|Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase|Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|ITTI population: subjects who received at least one dose of study drug in the induction phase|||participants|||Number
1275784|NCT00308581|Secondary|Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase|Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase|||participants|||Number
1275785|NCT00308581|Secondary|Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase|Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase|||participants|||Number
1275786|NCT00308581|Secondary|Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase|Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|Intent-to-treat Randomized Maintenance Phase (ITTR) population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase|||participants|||Number
1275787|NCT00308581|Primary|Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase|"Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.~The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."|Baseline to Week 6|Intent-to-treat Induction Phase (ITTI) population: subjects who received at least one dose of study drug in the induction phase|||participants|||Number
1275788|NCT00308555|Primary|Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use|Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.|Day 1, Day 5|The number was determined by the number of participants completing both Day 1 and Day 5 procedures.|||Geometric Mean Ratio||95% Confidence Interval|Number
1275789|NCT00308516|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|24 months|||||||
1275790|NCT00308516|Primary|Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment|The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment|24 months||||percentage of participants||95% Confidence Interval|Number
1275791|NCT00308308|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 52|Safety Population|||Number of events/subject-month|||Number
1275792|NCT00308308|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 52|Safety Population|||Number of events/subject-month|||Number
1275793|NCT00308308|Secondary|Incidence of Severe Hypoglycemia|"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:~Subject requires the assistance of another person;~Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);~Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,~Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms."|Baseline to Week 52|Safety Population|||percentage of participants|||Number
1275794|NCT00308308|Secondary|Incidence of Total Hypoglycemia|Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.|Baseline to Week 52|Safety population|||percentage of participants|||Number
1275795|NCT00308308|Secondary|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%|Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%|Baseline to Week 52|participants in ITT population with available data|||Participants|||Number
1275796|NCT00308308|Secondary|Change From Baseline in Fasting Plasma Glucose to Week 52|Change from baseline in fasting plasma glucose at Week 52|Baseline to Week 52|participants in ITT population with available data|||mg/dl||Standard Error|Least Squares Mean
1275797|NCT00308308|Secondary|Change From Baseline in Weight to Week 52|Change from baseline in weight at Week 52|Baseline to Week 52|participants in ITT population with available data|||kilogram||Standard Error|Least Squares Mean
1275798|NCT00308308|Primary|Compare the Mean Change From Baseline to Week 52 in HbA1c||Baseline to Week 52|Intention to treat (ITT) with Last Observation Carried Forward (LOCF)|||Percentage||Standard Error|Least Squares Mean
1275799|NCT00308230|Primary|BNP Levels|Levels of B-type naturietic peptide in the blood|1 day||||pg/ml||Standard Deviation|Mean
1275814|NCT00308139|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight from baseline (Day -3) to Week 30|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||kg||Standard Error|Least Squares Mean
1275800|NCT00308139|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 364|ITT Population who participated in the 30-week assessment period and not using SU at screening.|||events per subject-year||Standard Error|Mean
1275801|NCT00308139|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 364|ITT Population who participated in the 30-week assessment period and using SU at screening.|||events per subject-year||Standard Error|Mean
1275802|NCT00308139|Secondary|Ratio of Triglycerides at Week 364 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||ratio||95% Confidence Interval|Least Squares Mean
1275803|NCT00308139|Secondary|Ratio of Triglycerides at Week 30 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||ratio||Standard Error|Least Squares Mean
1275804|NCT00308139|Secondary|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364|Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1275805|NCT00308139|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364|Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1275806|NCT00308139|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30|Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1275807|NCT00308139|Secondary|Change in Total Cholesterol From Baseline to Week 364|Change in total cholesterol from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1275808|NCT00308139|Secondary|Change in Total Cholesterol From Baseline to Week 30|Change in total cholesterol from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1275809|NCT00308139|Secondary|Change in Blood Pressure From Baseline to Week 364|Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364|Day -3, Week 364|7-Year Completer Population using observed data.|||mmHg||Standard Deviation|Mean
1275810|NCT00308139|Secondary|Change in Blood Pressure From Baseline to Week 30|Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30|Day -3, Week 30|ITT Population using observed data.|||mmHg||Standard Error|Mean
1275811|NCT00308139|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 364|Change in fasting plasma glucose from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1275812|NCT00308139|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 30|Change in fasting plasma glucose from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1275813|NCT00308139|Secondary|Change in Body Weight From Baseline to Week 364|Change in body weight from baseline (Day -3) to Week 364|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||kg||95% Confidence Interval|Least Squares Mean
1275990|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|30 days||||Percentage of participants|||Number
1275815|NCT00308139|Secondary|Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)|Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.|Week 22|||||||
1275816|NCT00308139|Secondary|Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14|Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14|Day -3, Week 14|Evaluable Meal Tolerance Cohort consisted of ITT subjects who participated in the meal tolerance test and had adequate data to allow the reliable assessment of pharmacodynamics. Only subjects with non-missing baseline and Week 14 values were included in analysis.|||mg/dL||Standard Error|Least Squares Mean
1275817|NCT00308139|Secondary|Exenatide LAR Steady State Concentration From Week 29 to Week 30|Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.|Week 29 to Week 30|The Pharmacokinetics Population consisted of subjects who received exenatide LAR treatment, and had adequate plasma exenatide concentration-time data to allow for reliable evaluation of exenatide LAR pharmacokinetics.|||pg/mL||Inter-Quartile Range|Geometric Mean
1275818|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.0%|Percentage of subjects achieving HbA1c target values of <=6.0% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1275819|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 364|Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1275820|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1275821|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentages of subjects achieving HbA1c target value of <7% at Week 364|Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1275822|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentage of subjects achieving HbA1c target value of <7% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1275823|NCT00308139|Primary|Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)|Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval|Week 22|||||||
1275824|NCT00308139|Secondary|Change in HbA1c From Baseline to Week 364|Absolute change in HbA1c from Baseline (Day -3) to Week 364|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||percentage of total hemoglobin||95% Confidence Interval|Least Squares Mean
1275825|NCT00308139|Primary|Change in HbA1c From Baseline to Week 30|Absolute change in HbA1c from Baseline (Day -3) to Week 30 [Week 30 - Baseline]|Day -3, Week 30|The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 30 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1275826|NCT00308113|Secondary|Compare Side Effect Profiles of the Three Study Groups|To compare side effect profiles of the three regimens to the enhanced standard of care group, to include height, weight, weight/height ratio, body mass index, cataract formation, blood glucose, blood pressure, and behavioral changes.|12 months|No analysis was performed as the study was closed with N=3 out of 120 and side effects profile between groups could not be analyzed.||||||
1275827|NCT00308113|Primary|One Year Change in Pulmonary Function (Forced Expiratory Volume, FEV1 and Forced Vital Capacity, FVC)|Comparing change from baseline levels in pulmonary function (FEV1 and FVC) in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year.|12 months|No analysis was performed as only 1 out of 3 participants completed all the pulmonary function measurements before the protocol was closed.||||||
1275828|NCT00308113|Primary|One Year Change of Left Ventricular Mean Systolic Wall Stress/Rate-corrected Velocity of Fiber Shortening Relation.|Comparing change from baseline of mean systolic wall stress and rate-corrected mean velocity of circumferential shortening in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year. The values are obtained via an echocardiogram read locally at each site.|12 months|No analysis was performed as only 1 out of 3 participants completed all echocardiogram measurements before the protocol was closed.||||||
1275956|NCT00307164|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting HDL data was missing and post-baseline fasting HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
1275829|NCT00308087|Secondary|Summary of Cost Effectiveness|A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.|24 months|No participants were analyzed because the study was terminated early due to low enrollment.||||||
1275830|NCT00308087|Secondary|Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment|Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.|24 months|Intent to treat population.|||Days||Inter-Quartile Range|Median
1275831|NCT00308087|Secondary|Kaplan-Meier Estimates of Progression-Free Survival|Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.|24 months|Intent to treat population|||Days||Inter-Quartile Range|Median
1275832|NCT00308087|Secondary|Participant Summary of Best Response Across All Visits|"Count of participants' best response within categories defined by the International Working Group (IWG):~> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),~> Complete Response Unconfirmed (unconfirmed complete disappearance),~> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),~> Stable Disease (neither response nor disease progression),~> Progression (new lesion or increase by 50% of previously involved sites from nadir)."|up to 24 months|Intent to treat population|||participants|||Number
1275833|NCT00308087|Secondary|Summary of Treatment-Emergent Adverse Events (TEAE)|Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.|up to 12 weeks|Safety population|||participants|||Number
1275834|NCT00308087|Primary|Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12|Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.|Week 8 (confirmed at Week 12)|Intent to treat population|||participants|||Number
1275835|NCT00308074|Secondary|Brief Psychiatric Rating Scale for Children (BPRS-C)|"The Brief Psychiatric Rating Scale for Children is a 21-item rating scale to evaluate psychiatric problems based on the clinician’ s interview with the child/adolescent and parents. It has 7 scales: behavioral problems, depression, thought disorders, psychomotor excitation, withdrawal-retardation, anxiety, organicity. Ratings are based on a 7 point scale, from Not Present (scores 0) to Extremely Severe (scores 6 points). Total is the sum of the 21 items. The range of possible totals is 0 (no symptoms) to 126 (extremely severe).A decrease in score indicates improvement."|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.||||units on a scale||Standard Deviation|Mean
1275836|NCT00308074|Secondary|Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|10-item assessment of obsessive-compulsive symptoms in patients less than 18 years of age. There are 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale ( from 0=no symptoms/minimum severity, to 4=extreme symptoms/maximum severity). Total is the sum of 10 items. The range of possible totals is 0 (no symptoms) to 40 (severe). A decrease in value indicates improvement.|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.||||units on a scale||Standard Deviation|Mean
1275837|NCT00308074|Primary|Aberrant Behavior Checklist-Irritability Subscale|"Aberrant Behavior Checklist (ABC) The ABC is a 58 item symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. Items are rated on a 4-point scale (0=no problem to 3=severe problem). A decrease in score indicates improvement.~There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech.This study uses the Irritability subscale for its outcome. The Irritability subscale is the sum of 15 items. Each item is rated using the scale: 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The Irritability subscale total score ranges from 0 to 45. A decrease in score over time indicates improvement."|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.||||units on a scale||Standard Deviation|Mean
1275838|NCT00308074|Primary|Clinical Global Impressions-Improvement|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to evaluate how much the patient's illness has improved or worsened compared to their baseline condition at the beginning of the intervention. The ratings are evaluated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.||||units on a scale||Standard Deviation|Mean
1275839|NCT00308061|Secondary|Geometric Mean Titers for Anti-FMP1 Antibody|Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.|Days 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364|Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.|||geometric mean titers||95% Confidence Interval|Geometric Mean
1275840|NCT00308061|Primary|Number of Participants With Solicited Adverse Events by Immunization and Type|Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.|Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67||||Participants|||Count of Participants
1275957|NCT00307164|Secondary|Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting total cholesterol was missing and post-baseline fasting total cholesterol was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
1275841|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
1275842|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
1275843|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
1275844|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
1275845|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14|The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
1275846|NCT00307931|Secondary|C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14||Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||mg/L||Standard Deviation|Mean
1275847|NCT00307931|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||score on a scale|||Number
1275848|NCT00307931|Secondary|Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||score on a scale|||Number
1275849|NCT00307931|Secondary|Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Weeks 1, 6 and 14 or Withdrawal|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).|||participants|||Number
1275850|NCT00307931|Secondary|Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||participants|||Number
1275851|NCT00307931|Secondary|Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, and 14 or Withdrawal|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).|||participants|||Number
1275852|NCT00307931|Primary|Number of Patients With at Least a 100-point Decrease From Baseline in Crohn’s Disease Activity Index (CDAI) Score at Week 6|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline, Week 6|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).|||participants|||Number
1275866|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 84|The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
1275853|NCT00307801|Post-Hoc|Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to end-of Study MBL|The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.|||mL||Standard Deviation|Mean
1275854|NCT00307801|Post-Hoc|Proportion of Participants With Successful Treatment|End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.|||Proportion of participants|||Number
1275855|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 196|The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
1275856|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 84|The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
1275857|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 196|The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
1275858|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 84|The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
1275859|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 196|The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
1275860|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 84|The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
1275861|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 196|The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
1275862|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 84|The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
1275863|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 196|The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
1275864|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 84|The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
1275865|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 196|The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
1275867|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 196.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275868|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 84|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275869|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 196.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275870|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 84.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275871|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 196|The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||days||Standard Deviation|Mean
1275872|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 84|The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||days||Standard Deviation|Mean
1275873|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 196.|The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
1275874|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 84.|The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
1275875|NCT00307801|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale."|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275876|NCT00307801|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale."|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275877|NCT00307801|Secondary|Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196|The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275878|NCT00307801|Secondary|Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84|The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275930|NCT00307489|Secondary|HBeAg Seroconversion at Week 48|Defined as having negative serum HBeAg and positive serum antibody to HBeAg [anti-HBe] for subjects with positive serum HBeAg at baseline.|48 Weeks|RAT Analysis Set with Positive Baseline HBeAg. Non-Completers=Failure|||participants|||Number
1275879|NCT00307801|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196|The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275880|NCT00307801|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84|The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275881|NCT00307801|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275882|NCT00307801|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1275883|NCT00307801|Secondary|Change From Baseline in Ferritin Concentration at Treatment Day 196|Ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 196.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||ng/mL||Standard Deviation|Mean
1275884|NCT00307801|Secondary|Change From Baseline in Ferritin Concentration at Treatment Day 84|Ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 84.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||ng/mL||Standard Deviation|Mean
1275885|NCT00307801|Secondary|Change From Baseline in Hematocrit at Treatment Day 196.|Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.|Baseline (visit 5) and treatment day 196|ITT, all participants with assessments at baseline and day 196 for this outcome measure|||ng/mL||Standard Deviation|Mean
1275886|NCT00307801|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 196|Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.|Baseline (visit 5) and treatment day 196|ITT, all participants with assessments at baseline and day 196 for this outcome measure|||g/dL||Standard Deviation|Mean
1275887|NCT00307801|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 84|Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.|Baseline (visit 5) and treatment day 84|ITT, all participants with assessments at baseline and day 84 for this outcome measure|||g/dL||Standard Deviation|Mean
1275888|NCT00307801|Secondary|Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment|The number of total sanitary protection items used during the 90 days before treatment (baseline) and those used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to baseline.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments for baseline and efficacy phase for this outcome measure|||Sanitary protection products||Standard Deviation|Mean
1275889|NCT00307801|Secondary|Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment|A bleeding day is a day on which sanitary protection is required. The number of bleeding days was determined for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure|||Bleeding days||Standard Deviation|Mean
1275890|NCT00307801|Secondary|Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment|A bleeding episode is characterized by the following: • Bleeding for at least 2 days • Bleeding days can be separated by no more than 1 bleeding-free day • An episode stops with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. negative value indicates a reduction from baseline in the number of episodes while under treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure|||Bleeding episodes||Standard Deviation|Mean
1275991|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||3 years||||Percentage of participants|||Number
1275891|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 7 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.|||ml||Standard Deviation|Mean
1275892|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 3 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.|||ml||Standard Deviation|Mean
1275893|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 1 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.|||ml||Standard Deviation|Mean
1275894|NCT00307801|Secondary|Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT consisted of all randomized subjects enrolled with excessive bleeding. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|||ml||Standard Deviation|Mean
1275895|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 7|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 7 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure|||ml||Standard Deviation|Mean
1275896|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 3|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 3 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure|||ml||Standard Deviation|Mean
1275897|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 1|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 1 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure|||ml||Standard Deviation|Mean
1275898|NCT00307801|Secondary|Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment|Menstrual blood loss volume as assessed by the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. A negative value indicates a reduction in blood loss after treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure|||ml||Standard Deviation|Mean
1275899|NCT00307801|Secondary|Proportion of Participants With Improvement in the Patient’s Overall Assessment Scale at Treatment Day 196|According to the patient´s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Patients assessed the overall improvement at day 196 compared with admission to the study condition.|From baseline (visit 5, day 1) up to treatment day 196|ITT, all participants with assessment at day 196 for this outcome measure|||Proportion of participants|||Number
1275900|NCT00307801|Secondary|Proportion of Participants With Improvement in the Patient’s Overall Assessment Scale at Treatment Day 84|According to the patient’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Patients assessed the overall improvement at day 84 compared with admission to the study condition.|From baseline (visit 5, day 1) up to treatment day 84|ITT, all participants with assessment at day 84 for this outcome measure|||Proportion of participants|||Number
1275901|NCT00307801|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 196|According to the investigator’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 196 compared with admission to study data.|From baseline (visit 5, day 1) up to treatment day 196|ITT, all participants with assessment at day 196 for this outcome measure|||Proportion of participants|||Number
1275902|NCT00307801|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 84|According to the investigator’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 84 compared with admission to study data.|From baseline (visit 5, day 1) up to treatment day 84|ITT, all participants with assessment at day 84 for this outcome measure|||Proportion of participants|||Number
1275903|NCT00307801|Secondary|Proportion of Participants Cured From Frequent Bleeding|Frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall. Cure from frequent bleeding: no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and no increase from baseline in an individual patient’s total number of bleeding days occurred|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects who enrolled with frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall||||||
1275904|NCT00307801|Secondary|Proportion of Participants Cured From Excessive Bleeding|Excessive bleeding:>=2 bleeding episodes each with blood loss volume (MBL) of >=80 mL in 90-day period, assessed by alkaline hematin method. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. Cure from excessive bleeding: MBL in each episode <80 mL + blood loss volume associated with each bleeding episode is decrease of ≥50% from average of qualifying bleeding episodes (with blood loss volume ≥80 mL per episode during run-in)|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects who enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day run-in period, as assessed by the alkaline hematin method|||Proportion of participants|||Number
1275905|NCT00307801|Secondary|Proportion of Participants Cured From Prolonged Bleeding|Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days. Cure from prolonged bleeding: no bleeding episodes lasting more than 7 days and the decrease between maximum duration during run-in and maximum duration during the efficacy phase was at least 2 days.|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects with prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days|||Proportion of participants|||Number
1275906|NCT00307801|Primary|Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms|At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) >7 days, no >4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no >1 BE increase from baseline, no increase from baseline in individual patient’s total number of bleeding days and total number of bleeding days not >24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in.|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|Intent-To-Treat (ITT): all randomized subjects with ≥1 of the DUB symptoms in 90-day run-in phase: Prolonged bleeding: ≥2 bleeding episodes, each lasting ≥8 days Frequent bleeding: >5 bleeding episodes, with minimum of 20 bleeding days overall. Excessive bleeding: ≥2 bleeding episodes each with blood loss volume (=MBL) of ≥80 mL|||Proportion of participants|||Number
1275907|NCT00307736|Other Pre-specified|Pathologic Complete Response|The number of subjects who achieved a pathologic complete response as determine by pathologist, following completion of the study therapy. Pathologic complete response represents the absence of residual invasive disease in the rectum and in the regional lymph nodes.|3 years|Patients who completed study therapy.|||Participants|||Count of Participants
1275908|NCT00307736|Secondary|Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.|Surgical morbidity following R0 resection with one of the following procedures: abdominal perineal resection, low anterior resection, and low anterior resection with coloanal anastomosis.|3 years|Total study population excluding one patient who refused surgery.|||participants|||Number
1275909|NCT00307736|Secondary|Percentage of Participants With Disease-free Survival|Summary of disease free survival at 1, 2, and 3 years. Disease free survival is the length of time after primary treatment for cancer ends that the participant survives without any clinical signs or symptoms of that cancer. The data is shown of the percentage of participants still in disease free survival at one, two, and three years.|1, 2, 3 years||||percentage of participants||95% Confidence Interval|Number
1275931|NCT00307489|Secondary|Hepatitis B Early Antigen (HBeAg) Loss at Week 48|Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline.|48 Weeks|RAT Analysis Set with Positive HBeAg at Baseline. Non-Completers=Failure|||participants|||Number
1275932|NCT00307489|Secondary|Percentage of Participants With Normalized ALT at Week 48|Subjects with elevated ALT at baseline that return to normal by Week 48.|48 Weeks|RAT Analysis Set - subjects with ALT above ULN at baseline. Non-Completers=Failure|||percentage of participants|||Number
1275910|NCT00307736|Secondary|Summary of Grade 3 or Greater Toxicity|"Summary of grade 3 or greater toxicity by grade and type. All adverse events were evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.~Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4 Life-threatening consequences; urgent intervention indicated."|3 years|Toxicity was grouped together for all phase I dose cohorts and the phase II cohort in order to summarize all the grade 3 or greater toxicities associated with the combined study therapy, instead of focusing on the dose limiting toxicities from the phase 1 dose escalation of Erlotinib. Grade 3 or higher AE data is not available by dose cohort.|||participants|||Number
1275911|NCT00307736|Primary|Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy|MTD of Erlotinib was determined using a traditional 3 + 3 dose escalation scheme of three dose levels (50,100,150mg). Successive cohorts of 3-6 patients were enrolled into dose escalation cohorts for 14 day cycles. MTD reflects the highest dose of Erlotinib that had ≤1 out of 6 patients with Dose-Limiting Toxicity (DLT) at the highest dose level below the maximally administered dose. The maximally administered dose is the first dose that causes DLT in >33% of patients. DLT was defined as: Any grade 4 neutropenia, Any grade 3 thrombocytopenia, or Any ≥ grade 3 non-hematologic toxicity that results in greater than 7 days interruption in therapy.|3 years||||mg|||Number
1275912|NCT00307684|Secondary|Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score|Evaluation of treatment effects as rated by the subjects on the CAARS-S:S. best score: 0 worst score: 104|DB baseline, DB endpoint||||units on a scale||Standard Deviation|Mean
1275913|NCT00307684|Secondary|Change From DB Baseline to DB Endpoint in CGI-S Score|evaluation of treatment effects as rated by the investigator on the CGI-S scale. CGI-S is used to rate the severity of a subject’s illness on a 7- point scale ranging from 1 (not ill) to 7 (extremely severe).|DB baseline, DB endpoint|Intent to treat: all subjects who used study medication at least once|||units on a scale||Standard Deviation|Mean
1275914|NCT00307684|Secondary|Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint|Quality of life measured by Q-LES-Q best score: 100 worst score: 0|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once|||units on a scale||Standard Deviation|Mean
1275915|NCT00307684|Secondary|Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint|Assessment of the long term effect on overall functioning measured by CGI-S best score: 1 worst score: 7|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once|||units on a scale||Standard Deviation|Mean
1275916|NCT00307684|Primary|Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint|"To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS.~CAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54~Endpoint: last available post-baseline assessment."|DB baseline, DB endpoint|intent to treat: all subjects who used trial medication at least once|||units on a scale||Standard Deviation|Mean
1275917|NCT00307684|Secondary|Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores|"Long term efficacy of PR OROS MPH as assessed by investigator-rated CAARS total score, hyperactivity/impulsivity subscale score and inattention subscale score.~Subscale scores: best value: 0, worst value: 27"|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once|||units on a scale||Standard Deviation|Mean
1275918|NCT00307684|Primary|Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)|To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD)|Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks|intent-to-treat: all subjects who used the study medication at least once|||participants|||Number
1275919|NCT00307489|Secondary|Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168|P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|168 weeks|Non-completers = failure analysis|||Percent of Participants|||Number
1275920|NCT00307489|Secondary|HBsAg Loss at Week 168|Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.|168 weeks||||Participants|||Number
1275921|NCT00307489|Secondary|Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168|Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline.|168 weeks|Non-completer = Failure Analysis|||Participants|||Number
1275922|NCT00307489|Secondary|Hepatitis B Early Antigen (HBeAg) Loss at Week 168|Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline.|168 weeks|Non-completer = Failure Analysis|||Percent of Participants|||Number
1275923|NCT00307489|Secondary|Percentage of Participants With Normalized ALT at Week 168|Subjects with elevated ALT at baseline that return to normal by Week 48.|168 weeks||||Percent of Participants|||Number
1275924|NCT00307489|Secondary|Percentage of Participants With Normal ALT at Week 168|ULN for males = 43 U/L; ULN for females = 34 U/L|168 weeks|Non-completers = failure analysis|||Percent of Participants|||Number
1275925|NCT00307489|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168||168 weeks|Non-completers = failure analysis|||Percent of Participants|||Number
1275926|NCT00307489|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168||168 weeks|Non-completers = failure analysis|||U/mL||Standard Deviation|Mean
1275927|NCT00307489|Secondary|Change From Baseline in log10 Plasma HBV DNA Levels at Week 168||168 weeks|Non-completers = failure analysis|||log10 copies/mL||Standard Deviation|Mean
1275928|NCT00307489|Secondary|Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48|Defined as having negative serum HBsAg and positive serum antibody to HBsAg [anti-HBs] for subject with positive serum HBsAg at baseline.|48 Weeks|RAT Analysis Set Non-Completers=Failure|||participants|||Number
1275929|NCT00307489|Secondary|HBsAg Loss at Week 48|Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.|48 Weeks|RAT Analysis Set Non-Completers=Failure|||participants|||Number
1275992|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||2 years||||Percentage of participants|||Number
1275938|NCT00307437|Secondary|Number of Participants Visits With Psoriasis Area and Severity Index (PASI) 75 From Week 40 Through Week 52|Number of visits at which participants randomized at Week 28 achieved at least 75 percent improvement from baseline in PASI from Week 40 through Week 52 in participants randomized at Week 28. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 40 to Week 52|All participants randomized at Week 28 were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.|||Participants||Inter-Quartile Range|Median
1275939|NCT00307437|Secondary|Change in Dermatology Life Quality Index (DLQI) at Week 12|Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Baseline to Week 12|Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the partcipant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Units on a scale||Inter-Quartile Range|Median
1275940|NCT00307437|Secondary|Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12|Number of participants achieving a physician global assessment (PGA) (0 [none] to 5 [severe]) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).|Week 12|Intent to treat. All participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had missing data at Week 12.|||Participants|||Number
1275941|NCT00307437|Primary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12|Number of participants achieving greater than or equal to 75 percent improvement in PASI at Week 12. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 0 to Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had missing data at Week 12.|||Participants|||Number
1275942|NCT00307333|Secondary|Mortality||120 days||||participants|||Number
1275943|NCT00307333|Secondary|Days on Antibiotics||120 days||||days||Standard Deviation|Mean
1275944|NCT00307333|Secondary|Duration of Hospital Stay||120 days||||days||Standard Deviation|Mean
1275945|NCT00307333|Primary|Number of Ventilator-free Days||120 days||||days||Standard Deviation|Mean
1275946|NCT00307294|Secondary|Time to Progression|Time from start of treatment until the disease progression per RECIST criteria.|Up to 18 months||||months||95% Confidence Interval|Median
1275947|NCT00307294|Secondary|Overall Survival||36 months||||months||95% Confidence Interval|Median
1275948|NCT00307294|Secondary|Best Overall PSA Response|PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.|4 weeks|Patients that received greater than one cycle of therapy and met criteria for stable or progressive disease according to Prostate-Specific Antigen Working Group criteria.|||percentage of patients||95% Confidence Interval|Number
1275949|NCT00307294|Primary|Response Rate|The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.|24 weeks|Patients that received greater than one cycle of therapy.|||percentage of participants||95% Confidence Interval|Number
1275950|NCT00307164|Secondary|Change in Creatine Kinase From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 creatine kinase data was missing and post-baseline creatine kinase was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||IU/L||Inter-Quartile Range|Median
1275951|NCT00307164|Secondary|Change in Leukocytes From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 leukocyte data was missing and post-baseline leukocyte was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||cells*10^3/L||Inter-Quartile Range|Median
1275952|NCT00307164|Secondary|Change in Hemoglobin From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 hemoglobin data was missing and post-baseline hemoglobin was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||g/dL||Inter-Quartile Range|Median
1275953|NCT00307164|Secondary|Change in Fasting Triglycerides From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting triglyceride data was missing and post-baseline fasting triglyceride was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
1275954|NCT00307164|Secondary|Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting LDL data was missing and post-baseline fasting LDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
1275955|NCT00307164|Secondary|Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting non-HDL data was missing and post-baseline fasting non-HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF or due to associated triglyceride was >400 mg/dL. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
1275958|NCT00307164|Secondary|Change in Fasting Glucose From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting glucose was missing and post-baseline fasting glucose was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
1275959|NCT00307164|Secondary|Change in Fasting Lactate From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting lactate was missing and post-baseline fasting lactate was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mmol/L||Inter-Quartile Range|Median
1275960|NCT00307164|Secondary|Change in CD4+ Count From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 CD4+ data was missing and post-baseline data was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||cells/mm3||Inter-Quartile Range|Median
1275961|NCT00307164|Secondary|HIV-1 RNA Level||At Week 48|Intention to treat analysis with all randomized subjects. Reduced sample size was due to missing data at week 48.|||Participants|||Number
1275962|NCT00307164|Secondary|Change in Limb Fat From Baseline (Week 24 - Baseline)|Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups.|Baseline and Week 24|Intention to treat analysis with LOCF if week 24 limb fat data was missing and post-baseline before week 24 limb fat observation was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||grams||Inter-Quartile Range|Median
1275963|NCT00307164|Secondary|Number of Subjects Discontinuing Study Medication|Number of eligible subjects who discontinued study medication during the study period.|Through Week 48|Intention to treat analysis based on all subjects who started study treatment.|||Participants|||Number
1275964|NCT00307164|Secondary|Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities)|Time to safety events (grade 3 [Severe] or 4 [life-threatening] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry|Through Week 48|As-treated analysis with subjects stratified based on ART (d4T or AZT).|||weeks||Inter-Quartile Range|Median
1275965|NCT00307164|Primary|Change in Limb Fat (g) From Baseline|Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|Baseline and Week 48|Intention to treat analysis with last observation carried forward (LOCF) if week 48 limb fat data was missing and post-baseline limb fat was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||grams||Inter-Quartile Range|Median
1275966|NCT00307151|Secondary|Time From Randomization to Death|Results report 2nd percentile of time from randomization to death|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population|||Weeks||95% Confidence Interval|Number
1275967|NCT00307151|Secondary|Time From Randomization to HIV-related Disease Progression or Death|HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population|||Weeks||95% Confidence Interval|Number
1275968|NCT00307151|Secondary|Change in CD4 Percent From Entry to Week 48|Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.|48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population. Change reported if subject followed at least 48 weeks before DSMB unblinding of results for each Cohort|||Percent of CD4||95% Confidence Interval|Mean
1275969|NCT00307151|Secondary|Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus|Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Results included for any participant who was a virologic failure as defined in secondary outcome 4 and who had results available at study entry and virologic failure.|||participants|||Number
1275970|NCT00307151|Secondary|Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment|Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.|On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Uses follow-up from start of NVP or LPV/r component of study treatment until component switched or date of DSMB decision to unblind results, whichever occurred first|||Weeks||95% Confidence Interval|Number
1275971|NCT00307151|Secondary|Time From Randomization to Virologic Failure|Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population|||Weeks||95% Confidence Interval|Number
1275986|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|3 years||||Percentage of participants|||Number
1275972|NCT00307151|Secondary|Percent of Participants Experiencing Virologic Failure|Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.|Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population.|||Percent of participants|||Number
1275973|NCT00307151|Secondary|Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment|Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population|||Weeks||95% Confidence Interval|Number
1275974|NCT00307151|Primary|Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment|Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.|Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population|||Percent of participants|||Number
1275975|NCT00307125|Secondary|Number of Participants With Viral Replication of Polyomavirus (BKV)|Number of participants with viral replication of BKV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of a BKV infection. Polyomavirus BK is a significant pathogen in transplant recipients.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
1275976|NCT00307125|Secondary|Number of Participants With Evidence of Viral Replication of Epstein-Barr Virus (EBV)|Number of participants with positive viral replication of EBV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of EBV viral replication is indicative of active infection.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
1275977|NCT00307125|Secondary|Number of Participants With Viral Replication of Cytomegalovirus (CMV)|Number of participants with viral replication of CMV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of active CMV infection.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
1275978|NCT00307125|Secondary|Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy|Number of participants with loss of PTC C4d staining on kidney (renal) biopsy within 12 months post treatment initiation. PTC C4d staining on biopsy indicates organ rejection.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
1275979|NCT00307125|Secondary|Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD)|Number of participants with PTLD within 12 month post treatment initiation. Diagnosis of PTLD was made by B cell proliferation after therapeutic immunosuppression.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
1275980|NCT00307125|Secondary|Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation|Number of participants with graft loss, defined as the need for dialysis for greater than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure within 12 month post treatment initiation|1 year post treatment initiation|Intent-to-treat|||participants|||Number
1275981|NCT00307125|Secondary|Number of Deaths 12 Months Post Treatment Initiation|Number of participant deaths within 12 months post treatment initiation|12 months post treatment initiation|Intent-to-treat|||participants|||Number
1275982|NCT00307125|Primary|Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies|Number of participants with 50% decrease in circulating anti-HLA antibodies at any time within the first 12 months post kidney transplant by LuminexTM Beads Method. Luminex assays for quantitation and detection of cytokine and signal transduction proteins. Presence of circulating antibodies is indicative of the transplant recipient’s immune system responding to the transplanted organ as a foreign object or infection.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
1275983|NCT00307125|Primary|During Screening Phase: Timing of Alloantibody Development|Data were analyzed for 653 participants from the screening phase of the study. Of these, 79 (12%) developed de novo HLA-antibodies (anti-HLA Ab). This outcome looks at the average length of time (interval) from post kidney transplant until development of alloantibody. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection|During screening window of 3-60 months post kidney transplant|Screening sample|||Months||Standard Deviation|Mean
1275984|NCT00307125|Primary|During Screening Phase: Incidence of Alloantibody Development|Data were analyzed for 653 participants from the screening phase of the study. This outcome looked at the number of kidney transplant recipients that developed de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection.|During screening window of 3-60 months post kidney transplant|Screening sample|||participants|||Number
1275985|NCT00307086|Primary|Overall Survival (OS)|Median overall survival after first peripheral blood stem cell transplant (PBSCT).|40 months post transplant|All evaluable participants|||months||95% Confidence Interval|Median
1275993|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||1 year||||Percentage of participants|||Number
1275997|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-1123 days||||Percentage of participants|||Number
1275998|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-758 days||||Percentage of participants|||Number
1275999|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-393 days||||Percentage of participants|||Number
1276000|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|31-393 days||||Percentage of participants|||Number
1276001|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-30 days||||Percentage of participants|||Number
1276002|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-1123 days||||Percentage of participants|||Number
1276003|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-758 days||||Percentage of participants|||Number
1276004|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|0 -393 days||||Percentage of participants|||Number
1276005|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|31-393 days||||Percentage of participants|||Number
1276006|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|0-30 days||||Percentage of participants|||Number
1276007|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||3 years||||Percentage of participants|||Number
1276008|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||2 years||||Percentage of participants|||Number
1276009|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||1 year||||Percentage of participants|||Number
1276011|NCT00307047|Primary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|1 year||||Percentage of participants|||Number
1276012|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||180 days||||Percentage of participants|||Number
1276013|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||30 days||||Percentage of participants|||Number
1276014|NCT00307047|Secondary|All Cause Mortality||3 years||||Percentage of participants|||Number
1276015|NCT00307047|Secondary|All Cause Mortality||2 years||||Percentage of participants|||Number
1276016|NCT00307047|Secondary|All Cause Mortality||1 year||||Percentage of participants|||Number
1276017|NCT00307047|Secondary|All Cause Mortality||270 days||||Percentage of participants|||Number
1276018|NCT00307047|Secondary|All Cause Mortality||180 days||||Percentage of participants|||Number
1276019|NCT00307047|Secondary|All Cause Mortality||30 days||||Percentage of participants|||Number
1276020|NCT00307047|Secondary|All MI||3 years||||Percentage of participants|||Number
1276021|NCT00307047|Secondary|All MI||2 years||||Percentage of participants|||Number
1276022|NCT00307047|Secondary|All MI||1 year||||Percentage of participants|||Number
1276023|NCT00307047|Secondary|All MI||270 days||||Percentage of participants|||Number
1276024|NCT00307047|Secondary|All MI||180 days||||Percentage of participants|||Number
1276025|NCT00307047|Secondary|All Myocardial Infarction (MI)||30 days||||Percentage of participants|||Number
1276026|NCT00307047|Secondary|Acute Success (Clinical Procedure)|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.|Acute: At time of index procedure|Clinical procedure success is computed per subject|||Percentage of success|||Number
1276027|NCT00307047|Secondary|Acute Success (Clinical Device)|Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.|Acute: At time of index procedure|clinical device success is computed per lesion|||Percent of success|||Number
1276028|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|3 years||||Percentage of participants|||Number
1276029|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|2 years||||Percentage of participants|||Number
1276030|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|1 years||||Percentage of participants|||Number
1276031|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|270 days||||Percentage of participants|||Number
1276032|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|180 days||||Percentage of participants|||Number
1276033|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|30 days||||Percentage of participants|||Number
1276034|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|3 years||||percentage of participants|||Number
1276035|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|2 years||||percentage of participants|||Number
1276036|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|1 year||||percentage of participants|||Number
1276037|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|270 days||||percentage of participants|||Number
1276318|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 6M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort B (6 Month) will be presented.|6 Month||||Percentage|Participants|Standard Deviation|Mean
1276038|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|180 days||||percentage of participants|||Number
1276039|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|30 days||||percentage of participants|||Number
1276040|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|3 years|ITT population.|||percentage of participants|||Number
1276041|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|2 years|ITT population.|||percentage of participants|||Number
1276042|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|1 year|ITT population.|||percentage of participants|||Number
1276043|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|270 days|ITT population|||percentage of participants|||Number
1276044|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|180 days|ITT population|||percentage of participants|||Number
1276045|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|30 days|ITT population.|||percentage of participants|||Number
1276046|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|3 years|ITT, @ 3 years|||percentage of participants|||Number
1276047|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|2 years|ITT, @ 2 years|||percentage of participants|||Number
1276048|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|1 year|ITT, @ 1 yr|||percentage of participants|||Number
1276049|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|270 days||||percentage of participants|||Number
1276050|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|180 days||||percentage of participants|||Number
1276051|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|30 days||||percentage of participants|||Number
1276052|NCT00307034|Secondary|Number of Subjects With Serious Adverse Events|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|During the booster vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
1276053|NCT00307034|Secondary|Number of Subjects With Serious Adverse Events|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|During the primary vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
1276054|NCT00307034|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) post booster vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
1276055|NCT00307034|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) post-primary vaccination period, across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
1276056|NCT00307034|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C. Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.|During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
1276057|NCT00307034|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.|During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
1276058|NCT00307034|Secondary|Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies|Booster vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN), defined as the appearance of antibodies in subjects who were seronegative (Pre-booster status S-) (i.e., with antibody concentrations < 5 EL.U/mL) just before booster dose, and at least two-fold increase of pre-vaccination antibody concentrations in those who were seropositive (Pre-booster status S+) (i.e., with antibody concentrations ≥ 5 EL.U/mL) just before booster dose.|One month after (Month 9) the administration of the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Subjects|||Number
1276059|NCT00307034|Secondary|Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3)|Titers of antibodies are presented as geometric mean titers. Seroprotection status was defined as anti-polio types 1, 2 and 3 (Anti-polio 1, 2 and 3) antibody titers greater than or equal to (≥) the value of 8. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Titers||95% Confidence Interval|Geometric Mean
1276060|NCT00307034|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as milli international units per milliliter (mIU/mL). Seroprotection status was defined as anti-hepatitis B surface antigen (anti-HBs) antibody concentrations greater than or equal to (≥) the cut-off value of 10 mIU/mL. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1276086|NCT00306787|Secondary|Number of Patients With a Second Recurrence of Genital Herpes|Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.|Up to 6 months after investigator assessed healing of first recurrence of genital herpes|ITT population included all randomized patients who initiated treatment with (i.e. received any dose of) the study drug, with the intention of treating genital herpes recurrences.|||participants|||Number
1276061|NCT00307034|Secondary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity status was defined as anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) the cut-off value of 5 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1276062|NCT00307034|Secondary|Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as micrograms per milliliter (μg/mL). Seroprotection status was defined as anti-polyribosyl ribitol phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) the cut-off values of 0.15 μg/mL and ≥ 1.0 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1276063|NCT00307034|Secondary|Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids|Concentrations of antibodies are presented as geometric mean concentrations, expressed as international units per milliliter (IU/mL). Seroprotection status was defined as anti-diphteria and anti-tetanus toxoid antibody concentrations greater than or equal to (≥) the value of 0.1 IU/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1276064|NCT00307034|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).Seropositivity status was defined as Anti-PD antibody concentrations greater than or equal to (≥) the value of 100 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1276065|NCT00307034|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophacocytic activity against pneumococcal serotypes greater than or egual to (≥) the value of 8. The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Titers||95% Confidence Interval|Geometric Mean
1276066|NCT00307034|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1276067|NCT00307034|Secondary|Number of Seroprotected Subjects Against Pneumococcal Serotypes|A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs).|One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Subjects|||Number
1276068|NCT00307034|Primary|Number of Seroprotected Subjects Against Pneumococcal Serotypes|A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.|One month post-dose 2 (Month 3) administration of Synflorix™ vaccine|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Subjects|||Number
1276109|NCT00306384|Secondary|Change From Baseline in C-peptide Level|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data was available. Patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002 are not included.|||ng/mL||Standard Deviation|Mean
1276069|NCT00306917|Primary|Harris Hip Score (HHS)|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.|Preoperative, 6, 12, 24, 36, 48, and 60 months|Before the first interval there were five missing HHS scores for the DuoFix arm and four missing HHS scores for the Porocoat Porous Coated arm. At the final interval (60 months), there were eleven subjects in the DuoFix arm with complete HHS scores and there were fourteen subjects in the Porocoat Porous Coated arm with complete HHS scores.|||Units on a scale||Standard Deviation|Mean
1276070|NCT00306917|Secondary|Medical Imaging||postoperative, 6, 12, 24, 36, 48 and 60 months|||||||
1276071|NCT00306891|Secondary|Part B: Progression-free Survival (PFS)|"Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).~Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.~Progression (PD) Unequivocal progression of existing non-target lesions."|Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|ITT (intention-to-treat ) patients with baseline RECIST data.One patient was randomized and had baseline RECIST assessments, but did not have any further RECIST assessments. Therefore they were censored at baseline, meaning the lowest value in the range was set to zero.|||Days||Full Range|Median
1276072|NCT00306891|Secondary|Part B: Best Overall Response Rate (ORR)|"Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions.~Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions"|Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.|ITT (intention-to-treat ) patients with baseline RECIST data|||Participants|||Number
1276073|NCT00306891|Secondary|Part A: Apparent Total Body Clearance (CL/F)|Apparent total body clearance of drug from plasma|Measurements were collected up to 168 hours (following single dosing).||||L/h||Full Range|Geometric Mean
1276074|NCT00306891|Secondary|Part A: Terminal Phase Half-life (t1/2λz)|Terminal phase half-life|Measurements were collected up to 168 hours (following single dosing).||||hr||Full Range|Geometric Mean
1276075|NCT00306891|Secondary|Part A: Time to Peak or Maximum Concentration (Tmax)|Time to reach peak or maximum concentration or maximum response|Measurements were collected up to 168 hours (following single dosing).||||hr||Full Range|Geometric Mean
1276076|NCT00306891|Secondary|Part A: AUC (0-t)|Area under the curve from time 0 to the last measureable time point|Measurements were collected up to 168 hours (following single dosing).||||ng*h/mL||Full Range|Geometric Mean
1276077|NCT00306891|Primary|Part A: Maximum Plasma (Peak) Concentration (Cmax)|Maximum plasma drug concentration|Measurements were collected up to 168 hours (following single dosing).||||ng/mL||Full Range|Geometric Mean
1276078|NCT00306891|Primary|Part A: Area Under Plasma Concentration-time Curve (AUC)|Area under plasma concentration-time curve from zero to infinity|Measurements were collected up to 168 hours (following single dosing).||||ng*h/mL||Full Range|Geometric Mean
1276079|NCT00306852|Secondary|Failure Rate|Failure was prospectively defined as IOP greater than 21 mm Hg or less than 20 percent reduction below baseline on 2 consecutive follow-up visits after 3 months, IOP less than or equal to 5 mm Hg on 2 consecutive follow-up visits after 3 months, re-operation for glaucoma, or loss of light perception vision.|5 years||||percentage of participants|||Number
1276080|NCT00306852|Secondary|Need for Supplemental Medical Therapy|The number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years|5 years||||number of medications||Standard Deviation|Mean
1276081|NCT00306852|Secondary|Reoperations for Glaucoma|Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.|5 years||||participants|||Number
1276082|NCT00306852|Secondary|Visual Acuity|Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart|5 years|Participants who complete 5 years of follow-up|||Letters||Standard Deviation|Mean
1276083|NCT00306852|Primary|Rate of Complications|Complications associated with both surgical procedures|5 years||||participants|||Number
1276084|NCT00306852|Primary|Change in Intraocular Pressure|The data value from the Baseline visit and 5 year follow-up visit were combined. Specifically, values were calculated by subtracting the 5 Year Intraocular Pressure from the Baseline Intraocular Pressure.|Baseline to 5 years|Participants who completed 5 years of follow-up|||mm Hg||Standard Deviation|Mean
1276085|NCT00306787|Secondary|Time to a Second Recurrence of Genital Herpes|"Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:~From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or~From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence."|Up to 6 months after investigator assessed healing of first recurrence of genital herpes|ITT population. Patients with missing time-to-second recurrence were not included in the calculation of the median.|||days||Inter-Quartile Range|Median
1276337|NCT00303862|Secondary|KDR|Kinase insert domain-containing vascular endothelial growth factor receptor|Day 28 after initiation of therapy|Because trial was closed due to poor accrual, assays were not performed.||||||
1276087|NCT00306787|Secondary|Time to Resolution of Symptoms Associated With Recurrent Genital Herpes|Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.|72 hours after initiation of study medication up to Day 20|ITT population. If the resolution of any or all symptoms was not confirmed by a subsequent visit or diary entry, the time to resolution was censored at the time of the last diary entry. If a patient dropped out before any diary entries were created, the patient was assigned a censoring time of 0. n= number of patients with symptoms.|||hours||Inter-Quartile Range|Median
1276088|NCT00306787|Secondary|Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions|Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.|72 hours after initiation of study medication up to Day 20|ITT population. Median time was estimated by kaplan-Meier method by censoring the missing non-aborted times at last clinical observation. Patients with aborted lesions were assigned a time to healing of zero.|||days||Inter-Quartile Range|Median
1276089|NCT00306787|Secondary|Percentage of Participants With Aborted Genital Herpes Lesions|Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.|72 hours after initiation of study medication up to Day 20|ITT population. Patients who discontinued from the study before healing of non-aborted lesions was confirmed and patients who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were assumed to have non-aborted lesions in this analysis.|||Percentage of participants|||Number
1276090|NCT00306787|Primary|Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions|Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.|72 hours after initiation of study medication up to Day 20|Modified Intent To Treat (mITT) population. The mITT population included all patients who initiated treatment with the study drug, with the intention of treating genital herpes recurrences who developed non-aborted genital herpes lesions during the treated recurrence except those with confirmed aborted lesions at the final clinical assessment.|||days||Inter-Quartile Range|Median
1276091|NCT00306670|Primary|To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody.|the 2 recruited patients did not eradicate their inhibitors with 3 weeks of corticosteroids and did not progress in clinical trial since funding was eliminated and study terminated|When 25 patients have completed the study.|2 patients with acquired hemophilia A: two patients were recruited, but the sponsor terminated the study before the patients started treatment|||Participants|||Count of Participants
1276092|NCT00306592|Primary|Number of Participants With Antibodies to Natalizumab|‘Positive with unknown persistence’ is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. ‘Transient positive’ is defined as a positive at one timepoint but negative upon re-test at least 42 days later. ‘Persistent positive’ is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.|Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)|All participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody result after the first dose.|||participants|||Number
1276093|NCT00306592|Primary|Number of Participants With Hypersensitivity-related Adverse Events|For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.|Baseline through Week 48|Participants receiving at least 1 dose of study drug|||participants|||Number
1276094|NCT00306592|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)|AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.|Baseline through Week 48|Participants receiving at least 1 dose of study drug|||participants|||Number
1276095|NCT00306527|Primary|Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine|To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .|Day 1 to Day 7 postvaccination|This analysis was done on safety dataset|||Participants|||Number
1276096|NCT00306527|Secondary|Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.|"Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine.~Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer."|Day 22 postvaccination|This analysis was done on the immunogenicity subset.|||Percentages of subjects||95% Confidence Interval|Number
1276097|NCT00306527|Secondary|Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.|"Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine.~European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is > 70% for adults and >60% for elderly."|Day 22 postvaccination|This analysis was done on immunogenicity subset.|||Percentages of subjects||95% Confidence Interval|Number
1276098|NCT00306527|Secondary|Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects|"Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria.~The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects."|Day 22 postvaccination|The analysis was done on the immunogenicity subset.|||Ratio||95% Confidence Interval|Geometric Mean
1276099|NCT00306527|Secondary|Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects|"The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs.~The HI GMTs were evaluated using egg-derived antigen assay."|Day 22 postvaccination|The analysis was done on the immunogenicity subset.|||Titers||95% Confidence Interval|Geometric Mean
1276100|NCT00306527|Secondary|Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine|To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician’s visit and/or resulting in premature subject’s withdrawal from study.|Upto 6 months postvaccination|This analysis was done on the safety dataset.|||Participants|||Number
1276101|NCT00306488|Secondary|The Change in Total Drusen Area From Baseline to Year 2.||2 years|||||||
1276102|NCT00306488|Secondary|The Change in the Number of Scotomatous Points Between Study and Fellow Eyes From Baseline to Year 2.|Scotomatous points are testing points on microperimetry examination that are centered on the macula and report a lack of retinal sensitivity within the range tested.|2 years|||||||
1276103|NCT00306488|Secondary|The Change in Contrast Sensitivity as Measured by the Pelli-Robson Chart From Baseline to Year 2.|The Pelli-Robson Chart is comprised of 10 groups of 3 large letters with levels of contrast ranging from 100% (black against white) to 1% (very light gray against white). Each eye is assigned a score based on the contrast of the last group in which two or three letters were correctly read. A score of 2 log units, which represents a normal sensitivity contrast, indicates that the eye was able to detect two of the three letters with a contrast of 1 percent (contrast sensitivity = 100 percent or log 2).|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."|||Log Units|Participants|Standard Deviation|Mean
1276104|NCT00306488|Secondary|The Change in GA, as Measured on Stereoscopic Color Fundus Photography (CFP) From Baseline to Year 2.|GA was also measured using Stereoscopic Color Fundus Photography (CFP), which produces color images of the inside of the eye.|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."|||mm^2|Participants|Standard Deviation|Mean
1276105|NCT00306488|Secondary|The Change in Geographic Atrophy (GA), as Measured on Fundus Autofluorescence Imaging Using a Confocal Scanning Ophthalmoscope (HRA FAF) From Baseline to Year 2.|Geographic Atrophy (GA), or the death of photoreceptors and surrounding cells in the retina, is a common condition in patients with Age-Related Macular Degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The amount of GA is measured from images produced via a non-invasive technique called Fundus Autofluorescence Imaging, which uses a Confocal Scanning Ophthalmoscope to detect the naturally-fluorescing lipofuscin (the waste that is left behind by dead photoreceptors and digested by surrounding cells) that is prevalent at the border of the lesion.|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."|||mm^2|Participants|Standard Deviation|Mean
1276106|NCT00306488|Primary|The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|2 years|"Data collected from the 10 participants that completed the 24-month follow-up visit were analyzed.~Ten study eyes and 10 fellow eyes were analyzed."|||ETDRS Letters|Participants|Standard Deviation|Mean
1276107|NCT00306384|Secondary|Percentage of Participants With a Clinical Response|"Clinical response was defined based on the absolute value of HbA1c meeting one of two clinical targets at any post-baseline visit:~HbA1c ≤6.5%;~HbA1c ≤7.0%."|Weeks 2, 4, 8, 12, every 3 months up to 4 years, and 1 Day after final dose.|Safety set.|||percentage of participants|||Number
1276108|NCT00306384|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight to the last post-baseline observation collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set for whom data was available.|||kg||Standard Deviation|Mean
1276110|NCT00306384|Secondary|Change From Baseline in Insulin Level|The change from Baseline in fasting insulin at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data was available. Does not include patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002.|||μIU/mL||Standard Deviation|Mean
1276111|NCT00306384|Secondary|Change From Baseline in Proinsulin Level|"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.~Note: A transcription error occurred in the reporting of 1 proinsulin value for a patient in the alogliptin 25 mg completed group, for whom a partial patient ID number was mistakenly entered as an end-of-treatment proinsulin level."|Baseline and Year 4|Safety set where data were available.|||pmol/L||Standard Deviation|Mean
1276112|NCT00306384|Secondary|Percentage of Participants With Marked Hyperglycemia|"Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (≥11.10 mmol/L).~The Month 42 to Month 45 interval includes all marked hyperglycemic episodes occurring on or after Day 1247 (a 203-day visit window)."|Randomization up to 4 years.|Safety set where data were available.|||percentage of participants|||Number
1276113|NCT00306384|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in fasting plasma glucose (FPG) at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data were available.|||mg/dL||Standard Deviation|Mean
1276114|NCT00306384|Secondary|Change From Baseline Over Time in Glycosylated Hemoglobin|The change from Baseline in glycosylated hemoglobin (HbA1c; the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Endpoint was defined as the last postbaseline observation collected within 7 days after the last dose of open-label study drug.|Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42 and 45.|Safety set where data were available.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1276115|NCT00306384|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.|4 years|Safety set|||percentage of participants|||Number
1276116|NCT00306293|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. No SAEs were reported in this study.|Up to 148 days|Intent to treat exposed population comprised of all participants who received at least one dose of investigational product.|||Participants|||Count of Participants
1276117|NCT00306293|Secondary|Median Time to First Genital Herpes Recurrence (Days)|Time to first genital herpes recurrence was evaluated using Kaplan-Meier estimates of investigator-confirmed genital herpes recurrences censoring the data from participants who prematurely discontinue the study at the time of discontinuation.|Up to Day 68|First Period Efficacy Population included participants in the Intent to Treat Exposed Population and was used for efficacy analyses restricted to the First Treatment Period.|||Days||Full Range|Median
1276118|NCT00306293|Secondary|Percentage of Participants With at Least One Genital Herpes Recurrence|The proportion of participants with at least one genital herpes recurrence was defined as the number of participants with at least one investigator-confirmed genital herpes recurrence divided by the total number of participants with at least one clinic visit in the treatment period.|Up to 60 days in each treatment period (Up to 148 days)|Intent-to-Treat Crossover|||Percetage of participants|||Number
1276119|NCT00306293|Secondary|Percentage of Participants With no Shedding|The proportion of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data in the Treatment Period. Each participant’s study day was classified as either ‘shedding’ (positive HSV-2 result), ‘no shedding’ (negative HSV-2 result), or ‘unknown’ (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as ‘shedding’. Study shedding day was classified as either ‘clinical’ (investigator-confirmed presence of genital lesions) or ‘subclinical’ (no genital lesions) by the investigator during recurrence visits. Mean percent of days with no shedding was reported for each treatment group.|Up to 60 days in each treatment period (Up to 148 days)|Intent-to-Treat Crossover|||Percentage of participants|||Number
1276120|NCT00306293|Secondary|Mean Percent Days Clinical Shedding (Presence of Genital Lesions)|The percent of days with clinical HSV-2 shedding was defined as the percent of all days with PCR data for which clinical HSV-2 shedding was detected (shedding in the presence of a genital lesion). Each participant’s study day was classified as either ‘shedding’ (positive HSV-2 result), ‘no shedding’ (negative HSV-2 result), or ‘unknown’ (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as ‘shedding’. Study shedding day was classified as either ‘clinical’ (investigator-confirmed presence of genital lesions) or ‘subclinical’ (no genital lesions) by the investigator during recurrence visits. Mean percent of days with clinical HSV-2 shedding was reported for each treatment group.|Up to 60 days in each treatment period (Up to 148 days)|Intent-to-Treat Crossover|||Percentage of Days||Standard Deviation|Mean
1276265|NCT00305110|Post-Hoc|Pain Intensity Assessed Over 2-hour Time Frame|"Pain intensity is measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain possible). Participants are asked to rate their pain periodically over a 2 hour time period following infusion of the medication."|baseline up to 120 minutes after post infusion||||units on a scale||Inter-Quartile Range|Median
1276121|NCT00306293|Secondary|Mean Percent Days Subclinical Shedding (no Genital Lesions Present)|The percent of days with subclinical HSV-2 shedding was defined as the percent of all days with PCR data for which subclinical HSV-2 shedding was detected (shedding in the absence of a genital lesion). Mean percent of days with subclinical HSV-2 shedding was reported for each treatment group. Each participant’s study day was classified as either ‘shedding’ (positive HSV-2 result), ‘no shedding’ (negative HSV-2 result), or ‘unknown’ (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as ‘shedding’. Study shedding day was classified as either ‘clinical’ (investigator-confirmed presence of genital lesions) or ‘subclinical’ (no genital lesions) by the investigator during recurrence visits.|Up to 60 days in each treatment period (Up to 148 days)|Intent-to-Treat Crossover|||Percentage of days||Standard Deviation|Mean
1276122|NCT00306293|Primary|Mean Percent Days of Total Shedding (Clinical and Subclinical) as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for Herpes Simplex Virus Type 2 (HSV-2)|Each participant’s study day were classified as either ‘shedding’ (positive HSV-2 result), ‘no shedding’ (negative HSV-2 result), or ‘unknown’ (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab are positive, the day was classified as ‘shedding’. Study shedding day was classified as either ‘clinical’ (investigator-confirmed presence of genital lesions) or ‘subclinical’ (no genital lesions) by the investigator during recurrence visits. Percent of days with HSV-2 shedding was defined for each participant as the percent of days with PCR data for which HSV-2 shedding was detected by a positive PCR result, i.e., the number of days with HSV-2 PCR shedding divided by total number of days with PCR data, multiplied by 100. Sum of the percent clinical and nonclinical shedding days was reported as total shedding. Mean percent of days with HSV-2 shedding was reported for each treatment group.|Up to 60 days in each treatment period (Up to 148 days)|Intent to Treat Crossover population comprised of all participants in the Intent to Treat population who had at least one PCR swabbing result in each Treatment Period. Intent to Treat population comprised of all participants who received at least one dose of investigational product.|||Percent of days||Standard Deviation|Mean
1276123|NCT00306202|Secondary|Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment|FLT3 and KIT = These are fused genes found in participants with this type of leukemia.|At EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276124|NCT00306202|Secondary|Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline|FLT3 and KIT = These are fused genes found in participants with this type of leukemia.|At baseline (within 3 weeks before initiation of study therapy)|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276125|NCT00306202|Secondary|Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML|BCR-ABL = These are fused genes found in participants with this type of leukemia.|At EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276126|NCT00306202|Other Pre-specified|Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=<LLN–8.0 mg/dL, GR2=<8.0–7.0 mg/dL, GR3=<7.0–6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN–1.2 mg/dL, GR2=<1.2–0.9 mg/dL, GR3=<0.9–0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN – 2.5 mg/dL, GR2=<2.5 – 2.0 mg/dL, GR3=<2.0 – 1.0 mg/dL, GR4=<1.0 mg/dL.|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
1276127|NCT00306202|Other Pre-specified|Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0|"GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.~ULN=upper limit of normal."|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
1276128|NCT00306202|Other Pre-specified|Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0|"GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. White Blood Cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL; GR4=<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L; GR4=<25.0*10^9/L.~LLN=lower limit of normal."|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
1276129|NCT00306202|Secondary|Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML|BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9.|At baseline (within 3 weeks before initiation of study therapy)|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276130|NCT00306202|Secondary|Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group|"Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment.~y=years"|4 hours after oral dose|"All treated participants with CSF samples available. n=number of PK parameters included.~Each participant could have more than 1 CSF profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||ng/mL||Standard Deviation|Mean
1276266|NCT00305110|Secondary|Oxygen Saturation Measured Over 2-hour Time Frame|blood oxygen saturation is measured periodically from 1 minute to 120 minutes after the medication was infused|baseline to 120 minutes post infusion||||% oxygen saturation||Inter-Quartile Range|Median
1276131|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1276132|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||hour||Full Range|Median
1276133|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276134|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||hour||Standard Deviation|Mean
1276135|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1276136|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1276137|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||hour||Full Range|Median
1276138|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276139|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time, normalized by dasatinib dose level.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng.h/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
1276315|NCT00304031|Secondary|Progression-free Survival (PFS)||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
1276140|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-T] is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, normalized by dasatinib dose level.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng.h/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
1276141|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Dose Normalized Cmax is the maximum observed concentration of drug substance in plasma normalized for different dasatinib dose levels.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
1276142|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||hours||Geometric Coefficient of Variation|Geometric Mean
1276143|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||hours||Full Range|Median
1276144|NCT00306202|Secondary|Overall Survival (OS)|Defined as time in months from start of study therapy to death. The OS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median OS time was computed using the Brookmeyer and Crowley method.|From start of study therapy until death or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy. Participants lost to followup were censored on the last date the participant was known to be alive.|||months||95% Confidence Interval|Median
1276145|NCT00306202|Secondary|Progression Free Survival (PFS)|"Time in months from 1st first dose until progression (resistance or refractory disease) or death was first documented by investigator.~Progressive disease: Resistant disease for which investigator may electively stop treatment or refractory disease requiring cessation of study treatment.~The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley."|From the date of randomization to date of progression, death, last tumor assessment, or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|"All treated participants: Participants who received at least 1 dose of study therapy.~If no progression or death was reported, PFS was censored at the last assessment date done on-study (i.e., up to 30 days after last dosing date) at which non-progression was reported."|||months||95% Confidence Interval|Median
1276146|NCT00306202|Secondary|Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay.~MMR: Ratio of the BCR-ABL to ABL <10^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL <10^-3 on the international scale in participants with p210 variant.~BCR-ABL=the fused gene found in participants with this type of CML."|At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants (14 with p190 variant and 3 with p210 variant BCR-ABL transcripts) in stratum 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276147|NCT00306202|Secondary|Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML)|"Molecular response was calculated by measuring p210 variant of BCR-ABL transcripts in blood during treatment using quantitative polymerase chain reaction (qPCR) assay.~Major molecular response (MMR): Ratio of the BCR-ABL to ABL <10^-3 or 0.1% on the international scale.~Complete molecular response (CMR): Complete absence of BCR-ABL or the ratio is <10^-4.5 or 0.00316% on the international scale.~Confirmed MMR or CMR = Criteria met again >6 weeks. BCR-ABL=the fused gene found in participants with this type of CML."|At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276171|NCT00306202|Primary|Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia|The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.|From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy|||mg/m^2 QD|||Number
1276338|NCT00303862|Secondary|Performance of DCE_MRI|Binary (yes/no) indicator of whether a dynamic contrast-enhanced MRI (DCE-MRI)was successfully performed.|One month after initiating therapy|Because trial was closed due to poor accrual, MRI data were not collected.||||||
1276148|NCT00306202|Secondary|Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML)|"A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.~Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR).~Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in stratum 2/3: Participants who received at least 1 dose of dasatinib 80 mg/m^2.|||percentage of participants||95% Confidence Interval|Number
1276149|NCT00306202|Secondary|Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)|"A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.~HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR.~The Clopper and Pearson method was used to compute 95% exact CIs."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1 who received at least 1 dose of dasatinib 60 mg/m^2.|||percentage of participants||95% Confidence Interval|Number
1276150|NCT00306202|Secondary|Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Duration of CHR is the time (in months) from the first day criteria were met for CHR, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval until death or progression was first observed. Refer to Outcome Measure 20 for criteria for CHR (Stratum 1) and Outcome Measure 19 for CHR (Stratum 2/3).~The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first confirmed CHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 50 months).|Treated participants with CHR in strata 1 and 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.|||months||95% Confidence Interval|Median
1276151|NCT00306202|Secondary|Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Duration of MaHR is the time (in months) from the first day criteria were met for MaHR, provided they were confirmed later at least after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval, until death or progression was first observed.~MaHR: Defined as participants having as best response a CHR or CHRp. Refer to outcome measure 20 for criteria for CHR or CHRp. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first confirmed MaHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 37 months).|All treated participants with MaHR in stratum 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.|||months||95% Confidence Interval|Median
1276152|NCT00306202|Secondary|Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval.~Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3.~Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days).|All treated participants with CHR in strata 1 and 2/3.|||days||95% Confidence Interval|Median
1276153|NCT00306202|Secondary|Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML)|"Defined as time (in days) from first dose of dasatinib until the first day MaHR criteria were met, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval.~MaHR: Defined as participants having as best response a CHR or CHRp. Refer to Outcome Measure 15 for criteria for CHR and CHRp. Estimated by the Kaplan-Meier method and a 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days).|Treated participants with MaHR in stratum 2/3.|||days||95% Confidence Interval|Median
1276154|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML)|HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments.|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276155|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM.~Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276172|NCT00306189|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|All subjects who received >= 1 dose of investigational product and have a baseline and >= 1 post baseline measurement at the lumbar spine.|||Percent Change from Baseline||95% Confidence Interval|Mean
1276173|NCT00306163|Secondary|Safety and Tolerability||5 weeks|||||||
1276156|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML)|"HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR):~WBC in PB: <10,000/mm^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) <5%; Basophils in PB: <5%; Platelet count (untransfused): <450,000/mm^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly.~Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276157|NCT00306202|Secondary|Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks|"Defined as participants having as best response a CHR or CHRp.~Criteria:~CHR-WBC in PB:≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement).~CHRp-CHR except platelet count (untransfused) and ANC:20,000/mm^3 ≤platelet <100,000/mm^3 and /or 500/mm^3 ≤ANC ≤1000/mm^3."|After completion of Week 6 and 24 (measured at weeks 7 and 25)|All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276158|NCT00306202|Secondary|Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)|"Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp).~Criteria:~CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement).~CHRp-CHR except platelet count (untransfused) & ANC:20,000/mm^3 ≤platelet <100,000/mm^3 & /or 500/mm^3 ≤ANC ≤1000/mm^3."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276159|NCT00306202|Secondary|Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]|"Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator’s assessment) or death (for participants whose best response was CCyR).~CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months)|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.|||months||95% Confidence Interval|Median
1276160|NCT00306202|Secondary|Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML])|"Defined as the time (in months) from the first day that all criteria were met for MCyR until the date of progression (based on the Investigator’s assessment) or death (for participants whose best responses were MCyR and CCyR respectively).~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months)|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.|||months||95% Confidence Interval|Median
1276161|NCT00306202|Secondary|Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|Defined as time (in days) from the first dose of dasatinib until criteria were first met for MCyR. MCyR: A CyR that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% confidence interval (CI) for the median was computed using the Brookmeyer and Crowley method.|Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days).|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders.|||days||95% Confidence Interval|Median
1276162|NCT00306202|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.|||percentage of participants||95% Confidence Interval|Number
1276174|NCT00306163|Secondary|Δ (FVC/SVC) at PC20 (AMP)|Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.|Baseline and 5 weeks|||||||
1276316|NCT00304031|Primary|Overall Survival (OS)||From randomization to date of death or last follow-up. Analysis occurs after 647 deaths have been reported.|Eligible patients who were randomized to an adjuvant temozolomide arm and contributed follow-up data.|||months||95% Confidence Interval|Median
1276163|NCT00306202|Secondary|Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample.~Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:>65%-95% Ph+ cells in metaphase in BM. No CyR:>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases [%Ph+ <100%])."|Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|"All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy.~Stratum 2/3 dasatinib 80 mg/m^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study."|||participants|||Number
1276164|NCT00306202|Secondary|Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|After completion of Week 12 and 24 (measured at Weeks 13 and 25)|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276165|NCT00306202|Secondary|Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that is either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR).~CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276166|NCT00306202|Secondary|Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. AST and ALT: GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.|Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
1276167|NCT00306202|Secondary|Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=<LLN–8.0 mg/dL, GR2=<8.0–7.0 mg/dL, GR3=<7.0–6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN–1.2 mg/dL, GR2=<1.2–0.9 mg/dL, GR3=<0.9–0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN – 2.5 mg/dL, GR2=<2.5 – 2.0 mg/dL, GR3=<2.0 – 1.0 mg/dL, GR4=<1.0 mg/dL.|Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
1276168|NCT00306202|Secondary|Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. WBC: GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. ANC: GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL; GR4=<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L; GR4=<25.0*10^9/L.|Days 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
1276169|NCT00306202|Secondary|Number of Participants With Dose-limiting Toxicity (DLT)|"DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:-~Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days~GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution~Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days."|From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276170|NCT00306202|Secondary|Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.|"AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization.~Grade 3 = Severe; Grade 4 = Life-threatening or disabling."|From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy.|||participants|||Number
1276175|NCT00306163|Primary|PC20 AMP (Post-treatment Compared to Baseline)|Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron|Baseline and 5 weeks|The analyses on treatment effects were performed on all subjects who reached a PC20<640mg/mL.|||Logarithm (mg/mL)||Standard Deviation|Mean
1276176|NCT00305942|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Overall survival was measured from the date of study entry until the date of death.|18 months|All patients were assessed for overall survival.|||Months||95% Confidence Interval|Median
1276177|NCT00305942|Secondary|Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.|18 months|All patients were assessed for time to progression.|||Months||95% Confidence Interval|Median
1276178|NCT00305942|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|"Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.~The final response category assigned represented the best response obtained during treatment."|18 months|All patients were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1276179|NCT00305877|Secondary|Two-year Disease-free Survival (DFS)|Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).|Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years|Eligible and treated patients.|||Proportion of patients||95% Confidence Interval|Number
1276180|NCT00305877|Secondary|Two-year Overall Survival Rate|Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.|Assessed every 3 months for 2 years|Eligible and treated patients are included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1276181|NCT00305877|Primary|Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy|"Specific toxicities to be monitored pursuant to the primary endpoint include:~Any grade 5 toxicities~Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension~Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis~ECOG performance status decline by 2 or greater for >24 hours~Weight loss >10%"|Every 2 weeks while on treatment and for 30 days after the end of treatment|All treated patients were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1276182|NCT00305864|Secondary|Progression-free Survival (Phase II)|Progression will be defined as a > 25% increase in tumor area. Progression-free survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.|From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months.|All eligible patients|||months||95% Confidence Interval|Median
1276183|NCT00305864|Primary|Median Overall Survival (Phase II)|Survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months|All eligible patients.|||Months||95% Confidence Interval|Median
1276184|NCT00305864|Primary|Maximum Tolerated Dose of MGd (Phase I)|"Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was considered acceptable if no more than 1 patient of the 6 experience a DLT. If the current level was considered acceptable, then dose escalation occurred. Otherwise, the preceding dose level would be declared the maximum tolerated dose (MTD). The MTD would be used for the Phase II arm.~Rating scale: 0 = not the MTD, 1 = MTD"|From start of radiation therapy to 90 days,|Eligible patients who received protocol treatment.|||units on a scale|||Number
1276185|NCT00305773|Other Pre-specified|Time to Treatment Failure (TTF)|Time to treatment failure (TTF) was defined as the time from registration to until the date of treatment discontinuation of any reason. Patients receiving treatment at the time of analysis were considered censored. The median TTF with 95% CI was estimated using the Kaplan Meier method.|Duration of treatment (up to 17 cycles)||||days||90% Confidence Interval|Median
1276186|NCT00305773|Secondary|Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|Duration of study (up to 2 years)||||participants|||Number
1276187|NCT00305773|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 2 years)||||days||95% Confidence Interval|Median
1276188|NCT00305773|Secondary|Time to Progression (TTP)|Time to Progression (TTP) for each patient will be calculated as the number of days from date of registration to either date when disease progression was documented or date of last evaluation without disease progression. The TTP distribution will be estimated using the method of Kaplan-Meier|Duration of study (up to 2 years)|This data was not (and will never be) analyzed. In place of this outcome, time to treatment failure, analyzed and reported as a secondary outcome.||||||
1276189|NCT00305773|Primary|Confirmed Complete Response (CR) Rate|"The confirmed complete response rate was estimated by the number of participants with CR divided by the total number of evaluable participants.~According to the International Working Group (IWG) Criteria for response in AML, to be considered a CR, the following must be met for at least 4 weeks: ANC > 1500/mL, platelets > 100000/mL, no circulating blasts, bone marrow cellularity >20% (biopsy), trilineage maturation, < 5% bone marrow blasts, no auer rods and no extramedullary disease."|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
1276190|NCT00305760|Primary|Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population||Continuous||||Adverse Events|||Number
1276191|NCT00305643|Secondary|Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.|A secondary classification of palmar planter erythrodysethesia according to World Health Organization (WHO) criteria will be used for determination of the incidences of > grade 1 HFS by 16 weeks from the commencement of therapy.|At 16 Weeks|No analysis could be performed due to low accrual and no participants reaching the 16 week mark.||||||
1276192|NCT00305643|Primary|Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.|The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of > grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.|At 16 Weeks, with evaluations and blood test every 3 weeks.|No analysis could be performed due to low accrual and no participants reaching the 16 week mark.||||||
1276193|NCT00305604|Secondary|Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week|Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.|Week 1|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Day 7, the last observed measurement was carried forward to Day 7. Patients had the option to participate in self monitoring of glucose.|||mg/dL||95% Confidence Interval|Least Squares Mean
1276194|NCT00305604|Secondary|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1276195|NCT00305604|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1276196|NCT00305604|Primary|Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
1276197|NCT00305578|Primary|Change in 17-item Hamilton Depression Rating Scale From Baseline to 8 Weeks (Baseline - 8 Wks)|Scale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.|8 weeks||||units on a scale||Standard Deviation|Mean
1276198|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean percent change at week 50"|From baseline to Study Week 50||||mean percent change||Standard Deviation|Mean
1276199|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean change at week 50"|From baseline to Study Week 50||||units on a scale||Standard Deviation|Mean
1276200|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean percent change at week 22"|From baseline to Study Week 22||||mean percent change||Standard Deviation|Mean
1276201|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean change at week 22"|From baseline to Study Week 22||||units on a scale||Standard Deviation|Mean
1276202|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean percent change at week 50"|From baseline to Study Week 50||||mean percent change||Standard Deviation|Mean
1276203|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean change at week 50"|From baseline to Study Week 50||||units on a scale||Standard Deviation|Mean
1276204|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean percent change at week 22"|From baseline to Study Week 22||||mean percent change||Standard Deviation|Mean
1276205|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean change at week 22"|From baseline to Study Week 22||||units on a scale||Standard Deviation|Mean
1276206|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean percent change at week 50"|From baseline to Study Week 50||||mean percent change||Standard Deviation|Mean
1276207|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean change at week 50"|From baseline to Study Week 50||||units on a scale||Standard Deviation|Mean
1276208|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean percent change at week 22"|From baseline to Study Week 22||||mean percent change||Standard Deviation|Mean
1276209|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean change at week 22"|From baseline to Study Week 22||||units on a scale||Standard Deviation|Mean
1276210|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean percent change at week 50"|From baseline to Study Week 50||||mean percent change||Standard Deviation|Mean
1276211|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean change at week 50"|From baseline to Study Week 50||||units on a scale||Standard Deviation|Mean
1276212|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean percent change at week 22"|From baseline to Study Week 22||||mean percent change||Standard Deviation|Mean
1276213|NCT00305565|Post-Hoc|Regression Analysis of Change in MADRS Score vs. Total Charge Delivered Per Day|"Mixed models multivariate regression model was fitted for the outcome change from baseline MADRS score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior ECT history, total number of adequate drug trials and prior medication regimen).~The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes."|50 Weeks|50 Week Completers|||Units on a scale per log(mC/Day)||Standard Error|Least Squares Mean
1276214|NCT00305565|Post-Hoc|Regression Analysis of Change in IDS-C Score vs. Total Charge Delivered Per Day|"Mixed models multivariate regression model was fitted for the outcome change from baseline IDS-C score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior electroconvulsive therapy (ECT) history, total number of adequate drug trials and prior medication regimen).~The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes."|50 Weeks|50 Week Completers|||Units on a scale per log(mC/Day)||Standard Error|Least Squares Mean
1276215|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 50||||percentage of participants|||Number
1276216|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50||||percentage of participants|||Number
1276217|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 22||||percentage of participants|||Number
1276218|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22||||percentage of participants|||Number
1276219|NCT00305565|Secondary|Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 50 of the Long-term Phase (ITT Population).|"Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)~In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit."|At Study Week 50||||percentage of participants|||Number
1276220|NCT00305565|Secondary|Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 22 of the Acute Phase (ITT Population)|"Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)~In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit."|At Study Week 22||||percentage of participants|||Number
1276221|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of remitters at week 50. Remission was defined as a score of less than or equal to 9 on the MADRS."|From baseline to Study Week 50||||percentage of participants|||Number
1276222|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Sustained Responders at Study Week 50 (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the MADRS to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy."|From Baseline to Study Week 50||||percentage of participants|||Number
1276223|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50||||percentage of participants|||Number
1276224|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of remitters at week 22. Remission was defined as a score of less than or equal to 9 on the MADRS."|From baseline to Study Week 22||||percentage of participants|||Number
1276225|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22||||percentage of participants|||Number
1276226|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 5 on the QIDS-C."|From baseline to Study Week 50||||percentage of participants|||Number
1276240|NCT00305448|Secondary|Time to Progression (TTP)|Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.|every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)||||days||Full Range|Median
1276227|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50||||percentage of participants|||Number
1276228|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 5 on the QIDS-C."|From baseline to Study Week 22||||percentage of participants|||Number
1276229|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22||||percentage of participants|||Number
1276230|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 50||||percentage of participants|||Number
1276231|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the IDS-C to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy."|From baseline to Study Week 50||||percentage of participants|||Number
1276232|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50||||percentage of participants|||Number
1276233|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 22||||percentage of participants|||Number
1276234|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22||||percentage of participants|||Number
1276235|NCT00305565|Primary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.|From Baseline to Study Week 22||||units on a scale|Participants|Standard Error|Least Squares Mean
1276236|NCT00305448|Secondary|Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes|The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes|Baseline to 12 weeks|Patients who agreed to participate in the PK substudy.|||Vss/F (L)||Standard Deviation|Mean
1276237|NCT00305448|Secondary|Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body|The measure of dispersion for mean population clearance is based on the estimated inter-individual variance|Baseline to 12 weeks|Patients who agreed to participate in the PK substudy. The results are based on 148, 122 and 140 plasma-concentration records from patients in the 250 mg, 250 mg + LD and 500 mg treatment arms respectively.|||L/h||Standard Deviation|Mean
1276238|NCT00305448|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.||||percentage of participants|||Number
1276239|NCT00305448|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.|RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.|||||||
1276241|NCT00305448|Primary|Objective Response Rate (ORR)|"An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.~Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization"|baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)||||percentage of participants|||Number
1276242|NCT00305344|Primary|Children With T1D Underwent a Single Autologous UCB Transfusion|All participants were monitored for 2 years. Baseline and post-infusion mixed meal tolerance tests were performed to determine whether autologous cord blood infusion preserved endogenous insulin production. The change in median area under the curve for C-peptide (measure of insuln production) from baseline to to 2 years during a 2 hour mixed meal tolerance test was used as the primary outcome measure and was reported in ng/ml/120 minutes|Baseline to Year 2|All participants received their own autologous umbilical cord blood (UCB)|||ng /ml /120 min||Inter-Quartile Range|Median
1276243|NCT00305253|Secondary|Emergency Hysterectomy|incidence of emergency hysterectomy for cases of uterine atony|within 72 hours of study enrollment|Data on emergency hysterectomy are only for women with diagnosis of uterine atony.|||participants|||Number
1276244|NCT00305253|Secondary|Blood Loss Due to Obstetric Hemorrhage|cumulative blood loss measured hourly upon study admission by calibrated blood collection drape|within 72 hours of study enrollment|Blood loss information was missing on some patients.|||mL||Standard Deviation|Mean
1276245|NCT00305253|Primary|Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)||from early pregnancy to within 3 weeks postpartum|All patients enrolled in the study were used in this analysis.|||participants|||Number
1276246|NCT00305227|Secondary|Incidence of Vaginal Discharge||4 mo|||||||
1276247|NCT00305227|Primary|Incidence of Urinary Tract Infection|Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.|10 weeks|The reported analysis was by intention to treat. All study participants were used, except for 4 participants in whom the major outcome measure was unevaluable.|||participants|||Number
1276248|NCT00305162|Secondary|Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)|excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)|||participants|||Number
1276249|NCT00305162|Secondary|Incidence of ACUITY Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)|||participants|||Number
1276250|NCT00305162|Secondary|Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)|||participants|||Number
1276251|NCT00305162|Secondary|Incidence of GUSTO Severe / Life-threatening Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)|||participants|||Number
1276252|NCT00305162|Secondary|Incidence of All Cause Mortality|(excluding STEMI)|randomization through 1 year after randomization|mITT (excluding STEMI), based on 1 year completers|||participants|||Number
1276253|NCT00305162|Secondary|Incidence of Stroke||randomization through 30 days after randomization|mITT (excluding STEMI), based on available data|||participants|||Number
1276254|NCT00305162|Secondary|Incidence of IDR||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
1276255|NCT00305162|Secondary|Incidence of MI||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
1276256|NCT00305162|Secondary|Incidence of All-cause Mortality||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
1276257|NCT00305162|Secondary|Incidence of All-cause Mortality or MI|(composite incidence)|randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
1276258|NCT00305162|Secondary|Incidence of All-cause Mortality, MI or IDR|(composite incidence)|randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
1276259|NCT00305162|Secondary|Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI|(a patient could have multiple procedural events)|during index PCI|mITT (excluding STEMI) and based on available data|||participants|||Number
1276260|NCT00305162|Secondary|Incidence of Stroke|"Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:~primary hemorrhagic - stroke with focal collections of intracranial blood~ischemic cerebral infarction - stroke without focal collections of intracranial blood~infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding~uncertain - no imaging or autopsy data are available."|randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
1276261|NCT00305162|Secondary|Individual Incidence of IDR||randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
1276262|NCT00305162|Secondary|Individual Incidence of All-cause Mortality||randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
1276263|NCT00305162|Secondary|Incidence of All-cause Mortality and MI|(composite incidence)|randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
1276264|NCT00305162|Primary|Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)|(composite incidence)|randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
1276267|NCT00305110|Secondary|Oxygen Desaturation Measured Over 2-hour Time Frame|blood oxygen saturation less than 95% is considered oxygen desaturation. Blood oxygen saturation is normally above 95%. Oxygen desaturation of less than 90% is dangerous because there is less oxygen throughout the body for cellular energy. Prolonged or severe blood oxygen desaturation can result in injury or death.|immediately after infusion, up to 120 minutes post infusion||||participants||95% Confidence Interval|Number
1276268|NCT00305110|Secondary|Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg|Normal systolic blood pressure is approximately 120 mmHg. A low systolic blood pressure indicates blood, and therefore oxygen, are not being distributed around the body properly. This leads to a decreased amount of oxygen for the body to use and can result in injury or death if prolonged or severe.|Immediately after infusion, up to 120 minutes post infusion||||Participants|||Count of Participants
1276269|NCT00305110|Secondary|Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute|Normal respiratory rate ranges from 12 to 20 breaths per minute. The decreased respiration results in a decreased amount of oxygen entering the body and therefore low amount of oxygen supplied to the brain. Prolonged oxygen deprivation can result in injury or death. Respiratory rates lower than 12 breaths per minute is a sign of distress. Number of participants experiencing a respiratory rate lower than 12 breaths per minute is measured.|immediately after infusion, up to 120 minutes post infusion||||Participants|||Count of Participants
1276270|NCT00305110|Primary|Number of Participants Requiring Naloxone|Naloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed.|immediately after infusion, up to 120 minutes post infusion||||Participants|||Count of Participants
1276271|NCT00305058|Secondary|Number of Participants Satisfied With Pain Medication|"Number of participants who were satisfied with pain medication received, based on their response of good to excellent or poor to fair. Participants were asked to pick which response best fit their satisfaction with the pain medication they received 30 minutes after that medication was infused Good to Excellent or Poor to fair."|30 minutes after medication infused||||Participants|||Count of Participants
1276272|NCT00305058|Secondary|Number of Participants With Pain Relief|Pain relief here is a subjective measure indicated by the following categories: No, Slight, Moderate, and Complete. Participants were asked to pick the category that best fit their level of pain relief 30 minutes after medication was infused.|30 minutes after medication infused||||Participants|||Count of Participants
1276273|NCT00305058|Secondary|Number of Participants With a Change in Pain Score|Pain score is a measure of pain intensity using the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Data is separated into two groups: those with greater than or equal to 50% change in their pain score and those with less than 50% change in their pain score.|Baseline to 30 minutes after medication infused||||Participants|||Count of Participants
1276274|NCT00305058|Primary|Change in Pain Intensity|Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused|Baseline to 30 minutes after medication infused||||units on a scale||Standard Deviation|Mean
1276275|NCT00304954|Secondary|Changes in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) From Baseline to 24 Weeks||Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7||||Microns|||Number
1276276|NCT00304954|Secondary|Changes in Best-corrected Visual Acuity (BCVA) as Measured by the Standard Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol From Baseline to 24 Weeks|"The values in the table represent the denominator for the visual acuity in feet. A value of 20 represents normal 20/20 vision while increasing values for the denominator represent worsening vision."|Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7||||Feet|||Number
1276277|NCT00304954|Primary|Monthly Rates of Anti-VEGF (Vascular Endothelial Growth Factor) Injections||24 Weeks||||Injections per Month||Full Range|Median
1276278|NCT00304915|Primary|Percentage of Participants With Depression Treatment Response|Depression symptom severity over the past two weeks was measured using the Hopkins Symptom Checklist (SCL-20). The SCL-20 includes the 13-item depression scale plus 7 depression-related items from the Hopkins Symptom Checklist-90-Revised. The items are scored from 0 to 4 and averaged to provide a mean depression severity score from 0 to 4. Depression treatment response at 6-months was defined as a 50% decrease in mean SCL-20 score compared to baseline.|6 months|intent to treat analysis|||percent response|||Number
1276279|NCT00304746|Primary|21-item Hamilton Depression Rating Scale Score (HAM-D)|The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).|9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)|All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.|||units on a scale||Standard Deviation|Mean
1276280|NCT00304746|Secondary|Montgomery Asberg Depression Rating Scale (MADRS)|The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).|9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)|All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.|||units on a scale||Standard Deviation|Mean
1276281|NCT00304707|Primary|Smoking Abstinence|The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.|week 7, week 11 and week 24 after scheduled quit day||||participants|||Number
1276282|NCT00304512|Secondary|α-Gal A Activity In Leukocytes At Baseline, Week 12, And Week 48|Leukocytes were isolated from whole blood and lysed, and α-Gal A activity was measured using a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole [nmol] 4-MU/hr) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat. α-Gal A activity in leukocytes are presented by individual participants.|Baseline, Week 12 (end of treatment period), Week 48 (end of extension period)|PD Population: all participants who received study drug and had at least 1 postbaseline PD parameter recorded.|||nmol 4-MU/hr/mg protein|||Number
1276283|NCT00304512|Secondary|PK: Area Under The Concentration Versus Time Curve (AUC) After Administration Of Migalastat|The AUC to the last measurable concentration (AUC0-t) was evaluated in plasma following a single oral dose of migalastat on Day 1 and following multiple oral doses on Day 14 (2 weeks) and Day 84 (12 weeks). All samples were collected on each dosing day.|0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, and 10 hours (postdose)|PK Population: all participants who received study drug and had at least 1 postbaseline PK parameter recorded.|||nanograms*hours/milliliters (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1276284|NCT00304512|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 48 is presented. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Week 48|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1276285|NCT00304356|Primary|Nitazoxanide|stopping of diarrhea|30 days||||participants|||Number
1276286|NCT00304278|Secondary|Survival Post Treatment|Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates|22 months||||participants|||Number
1276287|NCT00304278|Primary|Number of Participants With Complete and Partial Response Using RECIST Criteria|Complete and Partial Response as defined by RECIST 1.0. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD|17 weeks||||Participants|||Count of Participants
1276288|NCT00304265|Primary|Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine|"Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference.~Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia."|Days 0 to 14 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1276289|NCT00304187|Primary|Percent of Meal Remaining/Minute|percent of meal remaining/minute|Measured at Week 7||||percent of meal remaining/minute||Standard Error|Mean
1276290|NCT00304187|Primary|Binge Frequency|Binge frequency was assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit.|Measured at Week 7|Participants for analysis included 13 patients in the erythromycin and 13 patients in the placebo group who completed at least 5 weeks of drug treatment.|||Binge Episodes/Week||Standard Deviation|Mean
1276291|NCT00304161|Secondary|Clinical Global Impression-Improvement Scale|"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale."|Week 8||||percentage of responders|||Number
1276292|NCT00304161|Primary|Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale|The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology–Clinician Rated (IDS-C), a 30-item (scores 0–84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a >50% decrease in IDS-C score from baseline.|Week 8||||percentage of improved participants|||Number
1276293|NCT00304096|Secondary|The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization||Days 1-78||||participants|||Number
1276294|NCT00304096|Primary|The Number of Participants Who Experienced Dose-limiting Adverse Events|Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity|30 days post administration of last vaccine||||participants|||Number
1276295|NCT00304083|Secondary|Provide Epidemiology and Clinical Presentation of the Number of Participants With NF1-associated MPNSTs.|Increase the knowledge of the epidemiology and clinical presentation of NF1-associated MPNSTs.|After 4 cycles|Clinical evaluation of patients with NF1 was performed at trial enrollment.|||Participants|||Count of Participants
1276296|NCT00304083|Secondary|Identify the Number of Participants With a Serum Biomarker to Predict the Presence of MPNST Versus Benign Plexiform Neurofibroma|Assess if a serum biomarker can be identified that predicts for the presence of a MPNST versus benign plexiform neurofibroma.|After 4 cycles|Data looked at response evaluable patients with MPNST and focused on the TOPO2A gene being amplified.|||Participants|||Count of Participants
1276297|NCT00304083|Secondary|Construct Tissue Microarray to Identify Novel Targets for Treatment for the Number of Participants With Available Tissue|Construct a tissue microarray from submitted tumor samples that will be used in the future to identify novel targets for treatment of MPNSTs. The tissue microarray looked at various gene deletions and amplifications.|After 4 cycles|The number of participants vary in the rows from overall number analyzed, due to the tissue that was available for testing.|||participants|||Number
1276317|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 18M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort C (18 Month) will be presented.|18 Month||||Percentage|Participants|Standard Deviation|Mean
1276298|NCT00304083|Secondary|Perform Pathologic Analysis of Tumor Samples to Analyze the Number of Participants With Markers as Predictors of Response|Evaluate the molecular biology of sporadic and NF1-associated MPNSTs by performing a detailed pathologic analysis of tumor samples with the goal to analyze if markers can be identified that predict for response to chemotherapy or outcome.|After 4 cycles|The rows are among three different categories: Histologic Variant, Cellularity and Necrosis.|||Participants|||Count of Participants
1276299|NCT00304083|Secondary|Response Evaluation Using WHO, RECIST, 18 FDG-PET and Volumetric MRI With Percent Necrosis in Tumor Specimens|Correlate response evaluation using WHO, RECIST, 18 FDG-PET and volumetric MRI with percent necrosis in tumor specimens from patients who undergo surgery for local control after chemotherapy.|After 4 cycles|33 patients were evaluable for response after cycle 4, response evaluation using WHO and RECIST was performed. Response evaluation was not assessed with 18 FDG-PET and volumetric MRI.|||Participants|||Count of Participants
1276300|NCT00304083|Secondary|Utility of Fludeoxyglucose F18 Positron Emission Tomography (18FDG-PET) and Automated MRI Volumetric Tumor Analysis to Assess Response to Treatment|Evaluate the utility of fludeoxyglucose F18 positron emission tomography (18FDG-PET) and automated MRI volumetric tumor analysis as tools to assess response to treatment.|After 4 cycles|This assessment involved 18FDG-PET and MRI imaging of the MPNST and plexiform neurofibroma component. Due to technical issues with MRI imaging, data was not reliably collected from any study participant to allow for meaningful analysis.||||||
1276301|NCT00304083|Secondary|Response of Plexiform Neurofibroma to Neoadjuvant Chemotherapy Using Volumetric MRI Analysis|Evaluate the response of plexiformneurofibroma (if present) to neoadjuvant chemotherapy using WHO criteria and volumetric MRI analysis as a tool for response assessment|After 4 Cycles (1 cycle=21 days)|MRI imaging of the MPNST and plexiform neurofibroma component was not sufficient to allow for volumetric analysis over time. Reasons include differences in imaging technique over time and incomplete coverage of the entire tumor.||||||
1276302|NCT00304083|Primary|Number of Participants With Response Rate (Complete Response and Partial Response)|WHO criteria was used to determine responses due to the nonspherical shape of most MPNST. Complete Response (CR), Disappearance of all target lesions; Partial response (PR), >=50% decrease of target lesions.|After 4 Cycles (1 cycle=21 days)|37/48 patients total were evaluable for response.|||Participants|||Count of Participants
1276303|NCT00304070|Secondary|Frequency of Tumor Spillage at the Time of Tumor Resection|The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.|Up to one year or while on protocol therapy, whichever is less||||Participants|||Count of Participants
1276304|NCT00304070|Secondary|Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.|The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.|Patients who had surgery at time of enrollment.|Fifty-eight eligible patients had material examined for the presence of (beta)-catenin mutations.|||Participants|||Count of Participants
1276305|NCT00304070|Secondary|Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.|The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group.|At study enrollment|The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group (Number of patients from Brazil: 23. Number of patients not from Brazil: 31)|||participants|||Number
1276306|NCT00304070|Secondary|Frequency of Lymph Node Involvement by Imaging.|The number eligible patients who have lymph node involvement by imaging at study enrollment.|At study enrollment|Seventy-five eligible patients had tumor imaging done at the time of study enrollment and evaluated for the presence of lymph node involvement|||Participants|||Count of Participants
1276307|NCT00304070|Secondary|Complications Associated With Radical Adrenalectomy and RLND|Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication.|Up to 1 month after surgery|Sixty-nine eligible patients received surgery of the primary tumor site or RPLND. Complication rates were considered over the entire population regardless of Arm/Group assignment. One patient had grade 3 abdominal pain attributed to surgery.|||participants|||Number
1276308|NCT00304070|Secondary|Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy|Up to 182 Days After Enrollment||||participants|||Number
1276309|NCT00304070|Primary|Five Year Event-free Survival (EFS)|The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.|Up to five years after enrollment||||Estimated probability five year EFS||95% Confidence Interval|Number
1276310|NCT00304031|Secondary|Correlation of PFS With OS at 6 Months||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
1276311|NCT00304031|Secondary|Toxicity||From start of treatment to end of follow-up|||||||
1276312|NCT00304031|Secondary|Correlation of Tumor MGMT Gene Methylation Status With Treatment Response||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
1276313|NCT00304031|Secondary|Comparison of OS and PFS in Patients With Methylated MGMT||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
1276314|NCT00304031|Secondary|Comparison of OS and PFS in Patients With Unmethylated MGMT||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
1276319|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 24M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort A (longitudinal) will be presented.|24 months||||percentage|Participants|Standard Deviation|Mean
1276320|NCT00303979|Secondary|Evaluate the Proportion of Sites That Demonstrate a Relative 20% or Greater Improvement in 2 or More of the 7 Performance Measures at 24 Months as Compared to Baseline.|The proportion of practices that achieved greater than or equal to 20% improvement in two or more of the 7 performance measures at 24 months as compared to baseline will be presented.|Study Completion||||Sites|Participants||Number
1276321|NCT00303979|Primary|To Observe Over the Aggregate IMPROVE-HF Practice Sites a Relative 20% or Greater Improvement in at Least 2 of the 7 Performance Measures at 24 Months Compared With Baseline.|The percent of patients that conformed to each performance measure will be calculated at baseline and 24 months. Based on the definition of each performance measure as defined in the performance measure constructs, each performance measure’s baseline percentage and 24 month percentage will be calculated. The change in percentages from baseline is the baseline percentage subtracted from the 24 month percentage. Each performance measure will be evaluated separately to determine whether there is a relative 20% or greater improvement from baseline. The difference in percentages from baseline to 24 months and associated 95% confidence intervals on the differences will be presented. The percent improvement from baseline for each performance measure will be tested using a large sample test (z-test) on a proportion.|24 Month|167 practices contributed data to the baseline chart review. Twelve of the practices withdrew from the study prior to the next chart review milestone. 155 of those practices’ data contributed to the follow up of the longitudinal cohort time points of 12 and 24 months post educational workshop.|||Num. of measures with 20%+ improvement|||Number
1276322|NCT00303966|Secondary|Changes in Plasma Level of Interleukin-8 (IL-8) From Baseline to Week 25|The change (post-pretreatment) will be calculated and tested using a paired t test. A negative value indicates a decrease with treatment.|Baseline and week 25|Study terminated early and enrolled only 5 patients. Data wasn't collected for this outcome.||||||
1276323|NCT00303966|Secondary|Changes in Vascular Endothelial Growth Factor (VEGF) From Baseline to Week 25|Changes in VEGF levels (post-pretreatment) will be assessed. A negative value indicates a decrease with treatment.|Baseline and week 25|Study terminated early after enrolling only 5 patients. Data wasn't collected for this outcome.||||||
1276324|NCT00303966|Secondary|Changes in Mean Microvessel Density From Baseline to Week 25|Mean microvessel density will serve as a marker of angiogenesis (other markers includes hot spot density). Will be examined using random-effects linear models.|Baseline and week 25|Study terminated early with only 5 patients. Data wasn't collected for this outcome.||||||
1276325|NCT00303966|Primary|Overall Survival|Overall survival will be defined as time from the start of treatment until death from any cause and will be evaluated using the Kaplan-Meier estimator.|Up to 5.5 years|Study terminated early and only 5 patients were enrolled.|||months||Standard Error|Median
1276326|NCT00303966|Primary|Time to Disease Progression|Time to disease progression will be defined as the time from treatment start until disease progression and will be evaluated using the Kaplan-Meier estimator. Those who do not progress will be censored at the time that they were last known to be progression free.|Up to 5.5 years|Study terminated early and only 5 patients were enrolled.|||months||Standard Error|Median
1276327|NCT00303966|Primary|Objective Response Rate|Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with >50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).|Up to week 25||||percentage of participants||95% Confidence Interval|Number
1276328|NCT00303953|Secondary|Progression-free Survival|Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.|assessed at week 8, then every 3 months for 3 years|Only eligible patients were included in the analyses.|||years||95% Confidence Interval|Median
1276329|NCT00303953|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|assessed every 3 months for 3 years|Only eligible patients were included in the analyses.|||years||95% Confidence Interval|Median
1276330|NCT00303953|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|assessed at week 8, and every 3 months for 3 years|All eligible patients who started treatment were included in assessing response estimates.|||participants|||Number
1276331|NCT00303901|Primary|Distant Failure Rate||at 3, 6, and 12 months||||% of participants with distant failure||95% Confidence Interval|Number
1276332|NCT00303901|Secondary|Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures||12 months after the last patient was enrolled|||||||
1276333|NCT00303901|Secondary|Correlate Procedural Parameters and Follow-up Imaging Parameters||at 3, 6, and 12 months|||||||
1276334|NCT00303901|Secondary|Rate of Complications and Adverse Reactions by Occurrences of Toxicities||at 3, 6, and 12 months|||||||
1276335|NCT00303901|Primary|Local Failure Rates by CT Scan||at 3, 6, and 12 months||||% of participants with local recurrence||95% Confidence Interval|Number
1276336|NCT00303862|Secondary|eNOS|Endothelial nitric oxide synthase gene (eNOS). Record genotype=number of minor alleles.|Baseline (prior to therapy)|Because trial was closed due to poor accrual, assays were not performed.||||||
1276344|NCT00303667|Secondary|Incidence of Post-transplant Lymphoproliferative Disorder (PTLD)|Post-transplant lymphoproliferative disorder (PTLD) is a virally-driven cancer of the lymphoid cells caused by immunosuppressive drugs taken after allogeneic stem cell transplantation to prevent or control graft versus host disease.|1 Year||||participants|||Number
1276345|NCT00303667|Primary|Disease-free Survival at 1 Year|Number of patients alive without evidence of disease at 1 year after transplant|1 Year||||participants|||Number
1276346|NCT00303667|Secondary|Number of Patients With Disease Relapse|Disease relapse is the recurrence of leukemia in patients who had cleared their leukemia after treatment. Patients with persistent leukemia are not evaluable for relapse.|1 Year|On the extended schema, 16/39 patients either did not clear their leukemia or died before relapse would have been detected (day 28), and thus were not evaluable for relapse.|||participants|||Number
1276347|NCT00303667|Secondary|Incidence of Chronic Graft Versus Host Disease|Chronic graft versus host disease is a severe long term complication created by infusion of donor cells into a foreign host|1 Year||||participants|||Number
1276348|NCT00303667|Secondary|Number of Patients With Treatment-Related Mortality|Death within the first 100 days related to treatment in patients without relapse or persistent disease.|Day 100||||participants|||Number
1276349|NCT00303667|Secondary|Incidence of Grade III-IV Acute Graft Versus Host Disease|Grade III-IV acute graft versus host disease is a severe short term complication created by infusion of donor cells into a foreign host|Month 6||||participants|||Number
1276350|NCT00303667|Secondary|Number of Patients With Graft Failure|Number of patients with graft failure defined as <500 donor neutrophils count by day 28 in the absence of residual or relapsed leukemia|Day 28|On the short schema, 1 of the 8 patients, and on the extended schema, 6 of the 39 patients, died prior to Day 28, the day on which engraftment was assessed. Thus, only 7 and 33 patients respectively were evaluable for that endpoint.|||participants|||Number
1276351|NCT00303667|Secondary|In Vivo Expansion of a Donor NK Cells NK Cell Product|Number of patients with in vivo expansion of donor NK cells. In vivo expansion of NK cell is defined as detection of >100 donor-derived NK cells per microliter of blood.|12 - 14 days after NK cell infusion|The protocol was amended to add this endpoint after the 8 subjects were enrolled on the short schema. Thus the relevant samples to determine NK expansion were not collected. On the extended schema, 3 of 39 patients died prior to the day on which in vivo donor NK cell expansion was assessed. Thus only 36 patients were evaluable for that endpoint.|||participants|||Number
1276352|NCT00303667|Primary|Disease-free Survival at 6 Months|Number of patients alive without evidence of disease at 6 months after transplant|Month 6||||participants|||Number
1276353|NCT00303628|Other Pre-specified|Change in Oxaliplatin-related Neurotoxicity Between Baseline and 12 Months|Change in oxaliplatin-related neurotoxicity between baseline and 12 months was measuring the long-term symptom of oxaliplatin-related neurotoxicity among the patients. Oxaliplatin-related neurotoxicity was measured using the FACT/GOG-Ntx subscale at baseline and 12 months after randomization. The range of the total score of the scale was between 0 and 44, and lower values indicate higher neurotoxicity. Change in oxaliplatin-related neurotoxicity between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated worsened symptom. This change in score was calculated for each individual patient who had the data.|assessed at baseline and 12 months after randomization|Patients with data about their oxaliplatin-related neurotoxicity measured using FACT/GOG Ntx subscale at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint.|||scores on a scale||Standard Deviation|Mean
1276354|NCT00303628|Other Pre-specified|Change in Rectal Function Between Baseline and 12 Months|Change in rectal function between baseline and 12 months was measuring the long-term rectal function among the patients. Rectal function was measured using the Bowel Function Questionnaire at baseline and 12 months after randomization. The total score of the questionnaire was calculated as the number of problems with bowel function (score range 0-11). Change in rectal function between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated improved rectal function. This change in score was calculated for each individual patient who had the data.|assessed at baseline and 12 months after randomization|Patients with data about their rectal function measured using the Bowel Function Questionnaire at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint.|||scores on a scale||Standard Deviation|Mean
1276355|NCT00303628|Secondary|Proportion of Patients Who Completed 12 Cycles of Treatment|In the study, treatment was repeated every 2 weeks for a total of 12 cycles on both arms. The total number of cycles of treatment patient received until going off treatment due to any reason was recorded. It was a measure of the tolerance of the therapy.|assessed at the end of treatment|Patients who received at least one cycle of protocol treatment|||proportion of participants|||Number
1276356|NCT00303628|Secondary|Patterns of Failure|Failure included recurrence, second primary cancer and death without recurrence.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|all randomized patients|||participants|||Number
1276357|NCT00303628|Secondary|5-year Disease-free Survival Rate|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer or death, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Kaplan-Meier method was used to estimate 5-year DFS rate.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|All randomized patients (intent-to-treat population)|||proportion of participants||95% Confidence Interval|Number
1276358|NCT00303628|Primary|5-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to date of death from any cause. Patients who were still alive were censored at last date of known alive. Kaplan-Meier method was used to estimate the 5-year OS rate.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|All randomized patients (intent-to-treat population)|||proportion of participants||95% Confidence Interval|Number
1276359|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale|Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||units on a scale||Standard Error|Least Squares Mean
1276360|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale|Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||units on a scale||Standard Error|Least Squares Mean
1276361|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||units on a scale||Standard Error|Least Squares Mean
1276362|NCT00303602|Secondary|Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint|Patient meets definition of metabolic syndrome if they have >=3 risk factors: Waist circumference (men>102cm, women>88cm); triglycerides >=1.7mmol/L; HDL cholesterol (men<1.04mmol/L, women<1.30mmol/L); blood pressure >135/>=85 mmHg; Fasting glucose >=6.1mmol/L|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||participants|||Number
1276363|NCT00303602|Secondary|Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)|HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward.|||percent sensitivity||Standard Deviation|Mean
1276364|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin||Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||percent||Standard Deviation|Mean
1276365|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin|Patients should be fasting a minimum of eight hours prior to serum insulin measurement.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||microIU/milliliter||Standard Deviation|Mean
1276366|NCT00303602|Secondary|Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose|Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||millimole/Liter||Standard Deviation|Mean
1276367|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)|Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||millimole/Liter||Standard Deviation|Mean
1276368|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Blood Pressure|Sitting blood pressure, taken from the same arm.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||mm Hg||Standard Deviation|Mean
1276369|NCT00303602|Secondary|Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale|Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||units on a scale||Standard Error|Least Squares Mean
1276370|NCT00303602|Secondary|Number of Participants Discontinuing the Trial by Visit (Week)|The number of participants who discontinued by visit (non-cumulative).|Visit 2 (Baseline) to Visit 7 (Week 16)|Intention to treat|||participants|||Number
1276371|NCT00303602|Secondary|Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period|Percentage loss of body weight = 100*(postbaseline weight - baseline weight)/baseline weight|Visit 2 (Baseline) to Visit 7 (Week 16)|Intention to treat|||participants|||Number
1276372|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Waist Circumference|Waist circumference is measured on a bare abodomen just above the hip bone.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat with last observation carried forward|||centimeters||Standard Deviation|Mean
1276373|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Weight|Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.|Visit 2 (Baseline) and Visit 7 (16 Weeks)|Intention to treat|||kilograms||Standard Error|Least Squares Mean
1276374|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.|Visit 2 (Baseline) and Visit 7 (16 Weeks)|Per protocol|||kilograms/square meters||Standard Deviation|Mean
1276375|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat with last observation carried forward|||kilograms/square meters||Standard Deviation|Mean
1276376|NCT00303602|Primary|Time Course of Change From Baseline in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.|Visit 2 (Baseline) to Visit 7 (16 Weeks)|Intention to treat|||kilograms/square meters||Standard Error|Least Squares Mean
1276377|NCT00303511|Primary|Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead|The ability to place a pacemaker with capture (have the pacemaker work properly) through totally thoracoscopic approach to epicardial pacing lead without requiring conversion to open procedure|30 days||||percentage of particiapants|||Number
1276378|NCT00303485|Secondary|Number of Participants With Any Adverse Event or Serious Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 7 months|The Safety Analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment.|||Participants|||Number
1276379|NCT00303485|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters|Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) and which also represents a clinically relevant change from Baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 – 550 *10^9/L), white blood cell (WBC) (3.0 - 18.0 *10^9/L), alanine aminotransferase (ALT) (0 – 110 U/L), creatinine (0 – 154 µmol/L), chloride (95 – 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ). Creatinine clearance was calculated using the Cockroft-Gault formula.|Up to 7 months|The Safety analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment. ‘n’ denotes the number of participants who received the indicated study drug for each arm.|||Participants|||Number
1276380|NCT00303485|Secondary|Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations|Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed.|Day (D)7, D14, D21 and D28 of Month 6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.|||Percent change||Full Range|Median
1276381|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL|Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.|Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.|||Percentage of participants|||Number
1276382|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL|Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.|||Percentage of participants|||Number
1276383|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent|The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.|||Percentage of participants|||Number
1276384|NCT00303485|Secondary|Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments|Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL). The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) * 100. Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7|Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.|||Percent change||95% Confidence Interval|Median
1276385|NCT00303485|Secondary|Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time|BSAP is a biochemical marker of bone formation and measured in units per litre (U/L). The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) * 100. The greater the percent decrease from Baseline, the greater the response to therapy. Baseline visit was defined as Visit 1.|Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.|||Percent change||95% Confidence Interval|Median
1276427|NCT00303446|Secondary|Manual Muscle Testing, Change From Baseline.|Manual muscle testing was performed using a modified Medical Research Council (MRC) scale (0=worst, 5=best); the average muscle score was based on 22 muscle groups.|0, 12, and 24 months||||MRC units on a scale||Standard Deviation|Mean
1276386|NCT00303485|Secondary|Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time|sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.|Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. “n” denotes number of participants who received the indicated study drug for each arm.|||Percent change||95% Confidence Interval|Median
1276387|NCT00303485|Primary|Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3|Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day 3|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.|||Percent change||95% Confidence Interval|Median
1276388|NCT00303472|Primary|Part B: Number of Participants With Adverse Events|The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part B.|Treatment period (8 weeks) plus treatment extension (1 year)|All participants who received at least one dose of study medication|||Participants|||Number
1276389|NCT00303472|Primary|Part A: Number of Participants With Adverse Events|The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part A.|Treatment period (4 weeks) plus treatment extension (1 year)|All participants who received at least one dose of study medication|||Participants|||Number
1276390|NCT00303472|Secondary|Part B: Week 7 Tmax|Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 7|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||Hours||Full Range|Median
1276391|NCT00303472|Secondary|Part B: Week 1 Tmax|Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||Hours||Full Range|Median
1276392|NCT00303472|Secondary|Part B: Week 7 AUC0-4|Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 7.|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||hr*pg/mL||Standard Deviation|Mean
1276393|NCT00303472|Secondary|Part B: Week 7 Ctrough|Measured romiplostim concentration at the end of the Week 7 dosing interval (Ctrough)|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||pg/mL||Standard Deviation|Mean
1276394|NCT00303472|Secondary|Part B: Week 7 Cmax|Maximum observed serum concentration (Cmax) of romiplostim during Week 7.|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||pg/mL||Standard Deviation|Mean
1276395|NCT00303472|Secondary|Part B: Week 1 AUC0-4|Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||hr*pg/mL||Standard Deviation|Mean
1276396|NCT00303472|Secondary|Part B: Week 1 Ctrough|Measured romiplostim concentration at the end of the week 1 dosing interval (Ctrough)|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||pg/mL||Standard Deviation|Mean
1276397|NCT00303472|Secondary|Part B: Week 1 Cmax|Maximum observed serum concentration (Cmax) of romiplostim during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||pg/mL||Standard Deviation|Mean
1276398|NCT00303472|Secondary|Part B: Duration of Platelet Response|Duration of platelet response per IWG criteria (absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks).|Treatment Period (8 weeks) and extension period (52 weeks)|Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who had a platelet response|||Weeks||Inter-Quartile Range|Median
1276399|NCT00303472|Secondary|Part B: Time to First Platelet Response|Participants achieving first platelet response according to IWG criteria, by study week. Platelet response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks. Platelet counts obtained within 72 hours of platelet transfusion were not evaluable for platelet response.|Treatment Period (8 weeks) and extension period (52 weeks).|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase|||Participants|||Number
1276400|NCT00303472|Secondary|Part B: Peak Platelet Count|Peak platelet count (10^9/L) during the treatment period.|Treatment Period (8 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.|||10^9/L||Inter-Quartile Range|Median
1276425|NCT00303446|Secondary|Timed 2-minute Walk, Change From Baseline|The subjects did the 2-minute walk in a 50-foot (15.2-meter) corridor three times, and the average distance was calculated. The subjects were allowed to use an assistive device and rest between the trials.|0, 12, and 24 months||||meters||Standard Deviation|Mean
1276401|NCT00303472|Secondary|Part B: Number of Participants With a Platelet Response Per IWG|The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.|Treatment period (8 weeks) and extension period (52 weeks).|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase|||Participants|||Number
1276402|NCT00303472|Secondary|Part A: Number of Participants With a Platelet Response Per IWG Criteria|The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.|Treatment period (4 weeks) and extension period (52 weeks).|Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who entered the treatment extension.|||Participants|||Number
1276403|NCT00303472|Secondary|Part B: Number of Participants With a Complete or Major Platelet Response|Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.|Treatment Period (8 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.|||Participants|||Number
1276404|NCT00303472|Secondary|Part A: Number of Participants With a Complete or Major Platelet Response|Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.|Treatment Period (4 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.|||Participants|||Number
1276405|NCT00303459|Secondary|Patient Global Self Assessment (PGSA) Status at Week 16|The PGSA is a questionnaire that allows the patient to compare his/her PAH status in response to the question “How do you feel about your PAH today compared with your last visit?” asked by the investigator. Patients use a seven-point scale to respond: markedly better, moderately better, mildly better, no change, markedly worse, moderately worse, or mildly worse.|Week 16|All randomized set, patients who completed the assessment|||participants|||Number
1276406|NCT00303459|Secondary|Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score|The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS) together with brief demographic questions. EQ-5D VAS asks respondents to rate their perception of their overall health on a vertical visual analogue scale with ‘best imaginable health state’ set at 100 and ‘worst imaginable health state’ set at 0.|Baseline to Week 16|All randomized set|||units on a scale||Standard Deviation|Mean
1276407|NCT00303459|Secondary|Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score|The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS). The descriptive system asks respondents to describe their health status. Health is defined in 5 dimensions: (1) mobility, (2) self care, (3) usual activities, (4) pain or discomfort, and (5) anxiety or depression. Each dimension is divided into 3 levels, indicating (a) no problem, (b) some or moderate problems, or (c) extreme problems. Respondents record their problem(s) in each of the 5 dimensions. Combinations of these levels define a total of 243 health states. A health state defined by the descriptive system of EQ-5D can be described by a 5-digit number with full health is indicated by 11111 and poorest health state by 33333. The EQ-5D calculated score was derived by re-assigning local scores for answers to each question and combining these local scores into a global score with ranges from 0 (worst possible outcome) to 1 (best possible outcome).|From baseline to Week 16|All randomized set|||units on a scale||Standard Deviation|Mean
1276408|NCT00303459|Secondary|Change From Baseline to Week 16 in Borg Dyspnea Index|The Borg dyspnea index was evaluated immediately after the 6MWT to obtain a rating of dyspnea at the end of the exercise using a scale from 0 (‘Nothing at all’) to 10 (‘Very, very severe – maximal’).|Baseline to Week 16|All randomized set|||units on a scale||Standard Deviation|Mean
1276409|NCT00303459|Secondary|Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP)|Blood sampling for the measurement of NT-pro-BNP was performed and the plasma concentrations of NT-pro-BNP were determined by a certified centralized laboratory.|Baseline to Month 20|All randomized patients with a baseline and at least one post-baseline value. Assessments considered are those where at least 60% of the patients have a post-baseline value|||Adjusted percentage ratio from baseline||95% Confidence Interval|Geometric Mean
1276410|NCT00303459|Secondary|Time to Death of All Causes From Baseline to End of Study|Kaplan-Meier estimate of percentage of participants without a mortality event.Time to death due to any cause.|Baseline to End of Study, approximately 86 months|All randomized set|||percentage of participants-Kaplan Meier|||Number
1276426|NCT00303446|Secondary|Adult Myopathy Assessment Tool, Change From Baseline|The Adult Myopathy Assessment Tool rates physical function and muscle endurance, with higher scores indicating better performance; it includes 7 timed functional tasks and 6 endurance tasks (0=worst, 45=best).|0, 12, and 24 months||||units on a scale||Standard Deviation|Mean
1276428|NCT00303446|Secondary|Creatine Kinase, Change From Baseline|Serum creatine kinase was determined in venous blood samples analyzed at the Department of Laboratory Medicine of the NIH Clinical Center.|0, 12, and 24 months||||Units/liter||Standard Deviation|Mean
1276411|NCT00303459|Secondary|Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16|Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.|From baseline to Week 16|All randomized set|||participants|||Number
1276412|NCT00303459|Secondary|Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT)|The 6MWT is a non-encouraged test, which measures the distance covered over a 6 minute walk; the patient is instructed to walk as far as possible in a 30 m long flat corridor, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Areas were to be well ventilated with air temperature controlled between 20 °C and 23 °C (68 °F to 76 °F). The test was to be administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6 minute period.|From baseline to week 16|All randomized set|||m||Standard Deviation|Mean
1276413|NCT00303459|Secondary|Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation|Kaplan-Meier estimate of percentage of participants without an event of death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation. Time to first confirmed death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation from baseline to end of study was confirmed by an independent Clinical Endpoint Committee.|Baseline to end of study, approximately 86 months|All randomized set|||percentage of participants-Kaplan Meier|||Number
1276414|NCT00303459|Primary|Time to First Confirmed Morbidity/Mortality Event up to the End of Study|"Kaplan-Meier estimate of percentage of participants without a morbidity/mortality event. A morbidity/mortality event is defined as the occurrence of a) death, b) hospitalization for worsening or complication of PAH or intravenous prostanoid initiation, c) atrial septostomy, d) lung transplantation, or e) worsening PAH, defined as moderately or markedly worsened PAH symptoms using a patient global self-assessment (PGSA) scale AND initiation of inhaled or subcutaneous prostanoids or the disease progression package (open-label bosentan). If a patient replied no change or mildly worse on the PGSA, a decrease in 6MWT of 20% versus last visit or 30% versus baseline is also required to confirm the event."|From baseline to end of study, approximately 86 months|All randomized set|||percentage of participants-Kaplan Meier|||Number
1276415|NCT00303446|Secondary|International Index for Erectile Function (IIEF), Change From Baseline|Sexual function was rated using the International Index of Erectile Function (IIEF). The total IIEF score (5-75, worst-best) was reported as the percent maximum (0-100%).|0, 12, and 24 months||||percent of maximum score||Standard Deviation|Mean
1276416|NCT00303446|Secondary|Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Mental Component Summary, Percent Change From Baseline|Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their mental quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10), and percent change in the norm-based scale was calculated.|0, 12, and 24 months||||percent change||Standard Deviation|Mean
1276417|NCT00303446|Secondary|Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Physical Component Summary, Change From Baseline|Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their physical quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10).|0, 12, and 24 months||||percent change||Standard Deviation|Mean
1276418|NCT00303446|Secondary|Activities of Daily Living, Change From Baseline|Subjects rated their daily activity with a modified 9-question Activities of Daily Living (ADL) questionnaire (0-4, fully impaired to normal).|0, 12, and 24 months||||units on a scale||Standard Deviation|Mean
1276419|NCT00303446|Secondary|Motor Unit Nerve Estimation, Change From Baseline|Motor unit number estimation (MUNE) was done with a statistical MUNE program, on the abductor pollicis brevis. All subjects were evaluated on the right side unless severe atrophy produced very low compound muscle action potentials; in this case, the left side was investigated or the abductor digiti minimi was substituted. A decrease in MUNE indicates a loss of motor units.|0, 12, and 24 months||||motor unit number||Standard Deviation|Mean
1276420|NCT00303446|Secondary|Peroneal Compound Muscle Action Potential, Change From Baseline|Nerve conduction studies were done on the peroneal nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months||||mVolts||Standard Deviation|Mean
1276421|NCT00303446|Secondary|Median Compound Muscle Action Potential, Change From Baseline|Nerve conduction studies were done on the median motor nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months||||mVolts||Standard Deviation|Mean
1276422|NCT00303446|Secondary|Sensory Nerve Action Potential Average, Change From Baseline|Nerve conduction studies were done on four sensory nerves (median, ulnar, radial, sural), and the amplitudes of the evoked responses were averaged. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months||||microVolts||Standard Deviation|Mean
1276423|NCT00303446|Secondary|Bulbar Rating Scale, Change From Baseline|The Bulbar Rating Scale includes eight domains each rated on a 1-4 scale, abnormal to normal. The original 8-32 point scale was transformed to a 0-100% scale to represent the responses as percentages.|0, 12, and 24 months||||percentage of maximum score||Standard Deviation|Mean
1276424|NCT00303446|Secondary|Swallow Score Average, Change From Baseline|Modified barium swallow studies were done at 0, 12, and 24 months. Twenty-five domains were assessed, and six were chosen for final analysis based on the abnormal findings in subjects evaluated at baseline: vallecular pooling and repeated-swallow, each assessed with thin liquids, purees, and solids (rated 1-4, abnormal to normal).|0, 12, and 24 months||||units on a scale||Standard Deviation|Mean
1276429|NCT00303446|Primary|Muscle Strength Change From Baseline|Quantitative muscle assessment (QMA) was done with a fixed frame dynamometer, a strain gauge tensiometer, and a computer-aided acquisition system. Maximal voluntary isometric muscle contractions were measured twice, the average was calculated, and the results were summed over 22 muscle groups (11 on each side). The total force was scaled for body weight and expressed as percent change from baseline. Measurements were performed at 0, 12, and 24 months. The calculated percent changes at 12 and 24 months are shown.|0, 12, and 24 months|The participants analyzed were those who were available for analysis at 12 and 24 months.|||percent change||Standard Deviation|Mean
1276430|NCT00303329|Secondary|The Absolute Change in Serum Ferritin (μg/L) Levels From Baseline to the End of the Study|Serum ferritin was monitored monthly and the dose of deferasirox was increased or decreased in steps of 5 to 10 mg/kg/day up to a maximum of 40 mg/kg/day if appropriate, every 3 months. If serum ferritin fell to 500 ng/mL or lower on two consecutive study visits, an interruption of treatment until serum ferritin was more than 500 ng/mL was considered.|Core study Baseline to end of extension study (up to 60 months)|The FAS comprised all participants who received at least one dose of deferasirox during either the core or extension studies.|||μg/L||Standard Deviation|Mean
1276431|NCT00303329|Secondary|The Absolute Change in Liver Iron Content (LIC) as Assessed by Superconducting Quantum Interference Device (SQUID) From Baseline to End of Study|Liver iron concentration was monitored at the end of the core study and then at the end of the extension study. High-risk participants, like participants with rare anemia, were excluded from any further potential liver biopsy, except if required and justified by the Investigator for the general care of the participant. Pediatric participants or participants with a medical contraindication to liver biopsy were allowed the use of SQUID in the extension study.|Core study Baseline to end of extension study (up to 60 months)|The FAS comprised all participants who received at least one dose of deferasirox during either the core or extension studies.|||mg Fe/g dw||Standard Deviation|Mean
1276432|NCT00303329|Secondary|The Change in Liver Iron Content (LIC) as Assessed by Liver Biopsy at Baseline to the End of the Study|Liver iron concentration was monitored at the start of the core study, the end of the core study, and then at the end of the extension study. High-risk participants, like participants with rare anemia, were excluded from any further potential liver biopsy, except if required and justified by the Investigator for the general care of the participant.|Core study Baseline to end of extension study (up to 60 months)|The full analysis Set (FAS) comprised all participants who received at least one dose of deferasirox during either the core or extension studies.|||mg Fe/g dw||Standard Deviation|Mean
1276433|NCT00303329|Primary|The Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Deaths|Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Core study Baseline to the end of the study (up to 60 months)|The safety analysis set comprised all participants who received at least one dose of deferasirox during either the core or extension studies.|||Participants|||Number
1276434|NCT00303316|Primary|Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|"Antibody titers determination:~Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay."|Day 0 (pre-booster) and Day 30 post-booster|Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).|||Titers||95% Confidence Interval|Geometric Mean
1276435|NCT00303316|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable."|Day 0 up to Day 30 post-booster vaccination|Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population.|||Participants|||Number
1276436|NCT00303316|Primary|Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.|Day 30 Post-booster Vaccination|Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).|||Participants|||Number
1276437|NCT00303316|Primary|Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).|Day 0 (Before booster vaccination)|Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).|||Participants|||Number
1276469|NCT00303108|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.|From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.|Evaluable population|||percentage of participants||95% Confidence Interval|Number
1276438|NCT00303186|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
1276439|NCT00303186|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm||Standard Deviation|Mean
1276440|NCT00303186|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
1276441|NCT00303186|Secondary|Health Assessment Questionnaire (HAQ)|HAQ: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
1276442|NCT00303186|Secondary|Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|Data was not statistically analyzed because of insufficient data collected and small sample size achieved.|||minutes||Standard Deviation|Mean
1276443|NCT00303186|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1276444|NCT00303186|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm/hr||Standard Deviation|Mean
1276445|NCT00303186|Secondary|Visual Analogue Scale for Pain (VAS-pain)|100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm||Standard Deviation|Mean
1276446|NCT00303186|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm||Standard Deviation|Mean
1276447|NCT00303186|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Measured using a 100 millimeter (mm) VAS ranging from 0 mm = very good to 100 mm = very bad.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm||Standard Deviation|Mean
1276448|NCT00303186|Secondary|Radiographic Score Based on Wassenberg|Radiographic score based on wassenberg consisted of 2 sub-scores, proliferation score (PS) assessing bone proliferation and destruction score (DS) assessing joint surface destruction. Score range for PS and DS was 0 to 160 (where higher score represented higher bone proliferation) and 0 to 200 (where higher score represented higher destruction), respectively. Total score = sum of PS and DS (range 0 to 360); higher score represented worse state.|Baseline, Month 12, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
1276449|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||percentage of participants|||Number
1276450|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||percentage of participants|||Number
1276451|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||percentage of participants|||Number
1276452|NCT00303186|Secondary|Number of Swollen and Tender Joints|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||joints||Standard Deviation|Mean
1276453|NCT00303186|Secondary|Maastricht Ankylosing Spondylitis Enthesis Score (MASES)|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
1276454|NCT00303186|Secondary|Occiput-to-wall Distance|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||cm||Standard Deviation|Mean
1276455|NCT00303186|Secondary|Chest Expansion Measurement|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||cm||Standard Deviation|Mean
1276456|NCT00303186|Secondary|Modified Schober's Test|Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bend forward, knees fully extended, with spine in full flexion.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||cm||Standard Deviation|Mean
1276457|NCT00303186|Secondary|Bath Ankylosing Spondylitis Radiology Index (BASRI)|BASRI- Radiographs of participants with AS were scored using the New York criteria for the sacroiliac joints on a scale of 2 to 4, the lumbar and cervical spine on a scale of 0 to 4 (0 = normal, 1 = suspicious, 2 = mild, 3 = moderate, 4 = severe). These 3 scores were added together to produce the BASRI-spine (BASRI-s) score (range 2 to 12). Similarly, hip joints were scored on a scale of 0 to 4 to give BASRI-hip (BASRI-h). Sum of BASRI-s and BASRI-h produced BASRI-total (BASRI-t) score; total range 2 to 16, higher score represented worse health state.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|Data was not statistically analyzed because of insufficient data collected and small sample size achieved.|||units on a scale||Standard Deviation|Mean
1276458|NCT00303186|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
1276459|NCT00303186|Secondary|Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a Visual Analog Scale (VAS) of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions. Total possible score range: 0-100, where higher score referred to higher impairment in the functional ability.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
1276460|NCT00303186|Secondary|Psoriasis Area and Severity Index (PASI)|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
1276461|NCT00303186|Secondary|Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)|PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||participants|||Number
1276462|NCT00303186|Secondary|Number of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 Response|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change >= 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||participants|||Number
1276463|NCT00303186|Primary|Incremental Cost-effectiveness Ratio (ICER)|ICER: ratio of the incremental cost of treatment over the incremental effectiveness. Incremental cost = difference in cost between baseline and month 60. Effectiveness was defined as quality adjusted life year (QALY) gained, i.e. difference in Euro Quality of Life 5 Dimension (EQ-5D)- health state profile utility score between baseline and month 60. (EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Total score range -0.594 to 1.000; higher score indicates a better health state.)|Baseline up to Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||ratio||95% Confidence Interval|Number
1276464|NCT00303186|Primary|Mean Cost Per Participant Per Month at Month 60|Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.|Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Euro/participant-month||Standard Deviation|Mean
1276465|NCT00303186|Primary|Mean Cost Per Participant Per Month at Month 12|Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.|Month 12|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.|||Euro/participant-month||Standard Deviation|Mean
1276466|NCT00303108|Secondary|1-year Overall Survival|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|1 year|ITT population|||probability of overall survival||95% Confidence Interval|Number
1276467|NCT00303108|Secondary|Progression-free Survival (PFS)|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of “non-target” lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel."|30 months|ITT population|||months||Full Range|Median
1276468|NCT00303108|Secondary|Duration of Response|Duration from date of stating treatment to the date of first CR or PR.|From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.|Patients who achieved CR or PR.|||months||Full Range|Median
1276513|NCT00302159|Primary|Median Progression Free Survival.|Progression free survival is the interval from initiation of treatment on protocol to symptomatic or radiographic progression. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.|up to 51 months||||months||95% Confidence Interval|Median
1276470|NCT00303069|Secondary|Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination||Baseline and Day 7 postvaccination|The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.|||Participants|||Number
1276471|NCT00303069|Primary|Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination||Baseline and Day 14 postvaccination|The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.|||Participants|||Number
1276472|NCT00303069|Primary|Number of Vaccine-related Serious Adverse Experiences Following Vaccination|Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|Through Day 84 postvaccination|The population analyzed included all subjects who were randomized, vaccinated, and had safety follow-up.|||Participants|||Number
1276473|NCT00302952|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||fL||Standard Deviation|Mean
1276474|NCT00302952|Primary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||pg||Standard Deviation|Mean
1276475|NCT00302952|Primary|Change From Baseline in Red Cell Distribution Width (RDW) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||% of mean corpuscle volume||Standard Deviation|Mean
1276476|NCT00302952|Primary|Change From Baseline in Hematocrit (Hct) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||% of packed red blood cells by volume||Standard Deviation|Mean
1276477|NCT00302952|Primary|Change From Baseline in Counts: White Blood Cells (WBC), Neutrophils, Bands, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, and Reticulocytes at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||10^3/uL||Standard Deviation|Mean
1276478|NCT00302952|Primary|Change From Baseline in CPK at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||U/L||Standard Deviation|Mean
1276479|NCT00302952|Primary|Change From Baseline in Potassium, Sodium, Chloride, and Total CO2 at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||mmol/L||Standard Deviation|Mean
1276514|NCT00302133|Secondary|% Subjects Abstinent|Proportion of subjects abstinent during the last 4 weeks of the trial|12 weeks||||percentage of participants|||Number
1281110|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
1276480|NCT00302952|Primary|Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||g/dL||Standard Deviation|Mean
1276481|NCT00302952|Primary|Change From Baseline in Total Bilirubin, Creatinine, BUN, Phosphorus, Calcium, and Glucose at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||mg/dL||Standard Deviation|Mean
1276482|NCT00302952|Secondary|Adjusted Mean Change From Baseline in Serum Anti-cyclic Citrullinated Peptide (Anti-CCP) by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)|Anti-CCP antibodies are autoantibodies frequently detected in the serum of individuals with rheumatoid arthritis. In this study, a positive value for anti-CCP was 8 IU/mL or greater; a negative value for anti-CCP was <8 IU/mL. Change= subtraction of Day 0 from Day 84 anti-CCP value. In general, high levels of the antibody indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Participants with measurements for designated time points included in analysis.|Baseline ( Day 0), Day 84 (Wk 12)|Intent-to-Treat with Available Data|||IU/mL||Standard Error|Mean
1276483|NCT00302952|Secondary|Adjusted Mean Change From Baseline in Serum IgM Rheumatoid Factor by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)|Rheumatoid factor (RF) is an antibody often present in the blood of a person with rheumatoid arthritis. In this study, a positive value for RF was 0.5 IU/mL or greater; a negative value for RF was <0.5 IU/mL. Change= Day 84 value minus Baseline value. In general, presence of the antibody indicates aggressive rheumatoid arthritis and higher risk of joint damage. Participants with measurements for designated time points included in analysis.|Baseline (Day 0), Day 84 (Wk 12)|Intent-to-Treat with Available Data|||IU/mL||Standard Error|Mean
1276484|NCT00302952|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Day 84 (ACR: American College of Rheumatology)|Patients were ACR20 Responders if they had: at least 20% improvement in both tender joint count (28 examined) and swollen joint count (28 examined), and 20% improvement in at least three of the following 5 remaining ACR core measures: • Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) • Patient's global assessment of disease activity (VAS 100 mm) • Physician's global assessment of disease activity (VAS 100 mm) • Patient self-assessed disability (Health Assessment Questionnaire (HAQ)) score • Acute phase reactant C-reactive protein. Participants with measurements for designated time points were included in analysis.|Day 84 (Wk 12)|Intent-to-Treat with Available Data|||Percentage of participants|||Number
1276485|NCT00302952|Secondary|Adjusted Mean Change From Baseline in the Disease Activity Score Using C-reactive Protein (DAS28-CRP) on Day 84|The DAS28-CRP score is on a scale of 0 to 10 and indicates current activity of rheumatoid arthritis (>5.1=high disease activity; 3.2-<=5.1=moderate disease activity; <=3.2=low disease activity; <2.6=remission). The score uses a combination of four variables: 1) the number of tender joints (of the 28 that are measured); 2) the number of swollen joints (of the 28 that are measured); 3) serum C-reactive protein (CRP) lab value in mg/L , and 4) Patient Global Assessment of Disease Activity. Using a formula, the physician determines the score. Participants with measurements for designated time points included in analysis.|Baseline (Day 0) to Day 84 (Wk 12)|Intent-to-Treat with Available Data|||Scores on a scale||Standard Error|Mean
1276486|NCT00302952|Primary|Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||U/L||Standard Deviation|Mean
1276487|NCT00302952|Primary|Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84|Blood draw for CRP, an acute phase reactant used to identify the presence of nonspecific inflammation. Change=Day 84 value minus Baseline value. Normal serum CRP reference range in this study is 0-4 mg/L (log transformed: -4.2 to 1.4). Participants with measurements for designated time points were included in analysis. An increased CRP level indicates the presence of inflammation. Reduced CRP levels could mean a decrease in inflammation.|Baseline (Day 0), Day 84 (Wk 12)|Intent-to-Treat with available data|||mg/L||Standard Error|Mean
1276488|NCT00302848|Primary|Number of Participants With Venous Thromboembolism (VTE)||1.5 to 5 years|"The primary analysis compares the users of DRSP and LNG. Its results are presented below. The comparison of users of DRSP and OCs containing other progestins was only conducted for exploratory reasons. This secondary analysis showed similar results and is described in more detail in the publication of study results, see citations."|||Participants|||Number
1276489|NCT00302731|Secondary|Number of Participants Without Change in Baseline and Follow up Bone Density|Comparison at baseline and month 12 by descriptive analysis of bone density. Assessing for changes in density related to hormone replacement therapy. Bone density readings for participants completing study in descriptive terms. Looking for significant change in bone density while on hormone therapy for 12 months. Those who had no change are counted below.|baseline and 12 months|Only 7 participants completed both the baseline bone density and 12-month follow up bone density resulting in a discrepancy in evaluable numbers compared to other outcome measures.|||Participants|||Count of Participants
1276490|NCT00302731|Primary|Number of Participants Without Change in Baseline and Follow up Mammograms|Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below.|baseline and month 12||||Participants|||Count of Participants
1276491|NCT00302731|Primary|Endometrial Measurement|Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participant in Arm 2: compared baseline to completion.|Baseline and month 12||||mm||Standard Deviation|Mean
1276492|NCT00302731|Primary|Change in Total Cholesterol|To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the average of the baseline value was subtracted from the average at completion.|Baseline and month 12||||mg/dL||Standard Deviation|Mean
1276493|NCT00302718|Post-Hoc|Incidence of Hypotension Among All Patients With Hypertension|Patients had at least one primary care encounter during the interval assessed. We looked four months from the encounter for evidence of hypotension, either an outpatient systolic blood pressure (BP) < 90 mm Hg, an outpatient diagnosis of hypotension, or both. We combined the intervention arms (physician-level, practice group-level, and combined physician and practice group-level incentives) into one arm due to low frequency of events and low power.|February-May 2009|All patients with hypertension from the physicians' panel who had an outpatient encounter between February and May 2009. We used data from automated processing of structured fields from electronic health records to evaluate this measure.|||percentage of all hypertensive patients|Participants||Number
1276494|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|After the washout period (May-August 2011)|The number of physicians listed is those who participated in the post-washout performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Participants||Number
1276495|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|Final intervention period (April-July 2009)|The number of physicians listed is those who participated in the final intervention performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Participants||Number
1276496|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|Baseline period (August-November 2007)|The number of physicians listed is those who participated in the baseline period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Participants||Number
1276497|NCT00302718|Primary|Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|After the washout period (May-August 2011)|The number of physicians listed is those who participated in the post-washout performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Participants||Number
1276498|NCT00302718|Primary|Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|Final intervention period (April-July 2009)|The number of physicians listed is those who participated in the final intervention period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Participants||Number
1276499|NCT00302718|Secondary|Colorectal Cancer (CRC) Screening, Low-density Lipoprotein (LDL) Cholesterol Levels, Hemoglobin (Hb) A1c Levels, and Beta Blocker Use||Secondary outcomes measured for baseline period, during the intervention period, and the post-washout period|||||||
1276500|NCT00302718|Primary|Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|Baseline period (August-November 2007)|The number of physicians listed is those who participated in the baseline period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Participants||Number
1276501|NCT00302458|Primary|Peak Plasma Concentration of d-Methylphenidate|Objective measure determined from blood samples, measured 4 hours after the dose|4 hours|All subjects received each combination of medications on a separate day (total= 5 days)|||mg/L||Standard Deviation|Mean
1276502|NCT00302328|Secondary|Visual Field Defects|visual field defects measured on humphrey perimetry|6 months|from predetermined power analysis|||participants|||Number
1276503|NCT00302328|Secondary|Anatomic Success|closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)|macular hole closure at 12 months|from initial power calculation of primary end point|||participants|||Number
1276504|NCT00302328|Primary|Visual Acuity (ETDRS Letters)|Visual acuity measured as the number of ETDRS letters at last follow-up|Visual acuity at 12 months|Decided from initial power calculation|||Visual acuity in letters||Standard Error|Mean
1276505|NCT00302211|Primary|Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) in Double-blind, Modified Intent To Treat (MITT) Population|Comparing number of Modified Intent to Treat population in double-blind who improved in the 6-minute walk distance - from baseline distance between 100-450 meters. Any increase in walk distance was considered improvement from baseline. The 6-minute walks were measured in meters using a test administrator, a stop watch, and markers to identify the course.|Day 1 to Week 16||||participants|||Number
1276506|NCT00302211|Other Pre-specified|Safety Objective|Assessment of the safety of the addition of iloprost inhlation solution in patients on oral sildenafil compared with placebo inhalation plus oral sildenafil. Safety variables observed were adverse events (AEs), laboratory data, and vitals.|Baseline up to 48 weeks||2010-05-31|05/2010||||
1276507|NCT00302211|Secondary|Assess the Efficacy of the Addition of Inhaled Iloprost in Patients With PAH Receiving a Stable Dose of Oral Sildenafil|The change in 6-minute walk distance (6-MWD) measured after inhalation, following 16 weeks of combination therapy with inhaled iloprost (administered 6 times or 4 times per day) inhaled iloprost plus sildenafil during the open-label extension phase.|Baseline Week 16 up to 48 weeks||2010-05-31|05/2010||||
1276508|NCT00302159|Primary|Percentage of Participants With Overall Survival at 6, 12, and 24 Months|Percentage of participants who were alive at 6, 12, and 24 months.|6, 12, and 24 months||||percentage of participants|||Number
1276509|NCT00302159|Primary|Median Overall Survival|Survival is the interval from the initiation of treatment on protocol to date of death.|up to 63.8 months||||months||95% Confidence Interval|Median
1276510|NCT00302159|Primary|Number of Participants With Best Response|Best response recorded from the start of treatment until disease progression/recurrence. Complete response is complete resolution of all contrast enhancing tumor documented at initiation of treatment on protocol, with no appearance of new lesions. Partial response is a >50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Minor response is a >25%, but <50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Stable disease is a change in tumor size less than MR but not demonstrating progressive disease. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol. Not evaluable means the participant cannot be evaluated (e.g., quality of scan).|up to 63.8 months||||participants|||Number
1276511|NCT00302159|Primary|Percentage of Participants With Progression Free Survival at 6, 12, and 24 Months|Percentage of participants who were progression free by 6, 12, or 24 months. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.|6, 12, and 24 months||||percentage of participants|||Number
1276512|NCT00302159|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|6 years, 7 months and 27 days||||participants|||Number
1277047|NCT00297115|Secondary|Post-bronchodilator FEV1 [L]|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
1276515|NCT00302133|Primary|Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial||12 weeks|One subject in the naltrexone group was considered an outlier and excluded from the analysis as it will disproportionally skew the results of small sample size, and one subject in the placebo group was lost to follow-up immediately after group allocation and before any first post allocation assessment.|||standard drinks/drinking day||Standard Deviation|Mean
1276516|NCT00302107|Primary|Structured Interview of Posttraumatic Stress Disorder (SIP)|Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate).|Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.|Randomized, took at least one dose of study medication, and returned for at least one visit post-randomization|||units on a scale||Standard Deviation|Mean
1276517|NCT00302081|Secondary|Virologic Response Rates at the End of Therapy. Biochemical Responses as Determined by ALT and AST Levels at the End of Treatment and at the End of Follow up.|"Virologic response is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) in the serum. A blood test is used to measure the level of ALT and AST. ALT response was defined as ALT<40 IU/L (international units per liter).~This was not a prespecified key secondary outcome."|End of treatment: 24 weeks for arms [PEG2b 1.5/R (24 weeks)] and [PEG2b 1.0/R (24 weeks)]; 16 weeks for arm [PEG2b 1.5/R (16 weeks)]. Follow-up of 24 weeks for each arm.|||||||
1276518|NCT00302081|Primary|The Number of Participants Who Achieve a Sustained Virologic Response (SVR)|A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid [HCV-RNA] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.|24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.|Intent-to-Treat (ITT) population|||participants|||Number
1276519|NCT00302068|Secondary|Interleuken 6 (IL-6)||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||pg/ml||Standard Deviation|Mean
1276520|NCT00302068|Secondary|Baroreflex Sensitivity (BRS)||Baseline, 16 weeks|Analysis based on 92 participants with valid baseline measurement.|||msec/mmHg||Standard Deviation|Mean
1276521|NCT00302068|Secondary|Platelet Factor 4||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||IU/ml||Standard Deviation|Mean
1276522|NCT00302068|Secondary|C-reactive Protein (CRP)||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||ug/ml||Standard Deviation|Mean
1276523|NCT00302068|Secondary|Percent Change in Flow Mediated Dilation (FMD)|Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.|Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||percentage change|||Number
1276524|NCT00302068|Secondary|Heart Rate Variability (HRV)|HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R—R intervals (SDNN)|Baseline, 16 weeks|Analysis based on 93 participants with valid baseline measurements.|||millisecond||Standard Deviation|Mean
1276525|NCT00302068|Primary|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.|Measured at 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||Raw changes in Ham-D scores||95% Confidence Interval|Mean
1276526|NCT00302055|Secondary|Rate of Community Program Participation||6 months|||||||
1276527|NCT00302055|Secondary|Self Report Physical Activity||12 months|||||||
1276528|NCT00302055|Primary|Weight Loss|We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)|12 months||||kilograms||95% Confidence Interval|Mean
1276529|NCT00302042|Secondary|Change in Dietary Composition||Baseline, 6 months|||||||
1276530|NCT00302042|Secondary|Rate of Community Program Participation||Baseline, 6 months|||||||
1276531|NCT00302042|Secondary|Physical Activity Level||Baseline, 6 months|||||||
1276532|NCT00302042|Primary|Change in Weight|6 months minus baseline|Baseline, 6 months||||percentage of change in weight||95% Confidence Interval|Mean
1276533|NCT00302003|Secondary|Overall Survival|Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.|At 60 months|Eligible (n=278). Follow-up for censored patients (n=277) is 76 months (range: 4.7 to 109 months).|||Probability of survival||95% Confidence Interval|Number
1276565|NCT00301756|Secondary|Progression-free Survival|Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Duration of time from start of treatment to time of progression, assessed up to 5 years||||months||95% Confidence Interval|Median
1276534|NCT00302003|Primary|Event Free Survival (EFS)|Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).|At 60 months|Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).|||Probability of survival||95% Confidence Interval|Number
1276535|NCT00302003|Primary|Intensive Therapy Free Survival (ITFS).|Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.|At 60 months|Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).|||Probability of survival||95% Confidence Interval|Number
1276536|NCT00302003|Primary|Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).|Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).|At 60 months|Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).|||Probability of survival||95% Confidence Interval|Number
1276537|NCT00301964|Secondary|Histologic Grade|G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
1276538|NCT00301964|Secondary|Initial Performance Status|Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
1276539|NCT00301964|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients.|||months||Inter-Quartile Range|Median
1276540|NCT00301964|Secondary|Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for the first 6 months; then every 4 cycles until progression or death, up to 5 years.|Eligible and treated patients.|||months||Inter-Quartile Range|Median
1276541|NCT00301964|Primary|Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.||Up to 5 years|Eligible and treated patients|||Participants|||Count of Participants
1276542|NCT00301964|Primary|Best Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|study entry through completion|Total number eligible and evaluable participants|||participants|||Number
1276543|NCT00301964|Primary|Progression-free Survival Greater Than 6 Months|Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|6 months|Total number of eligible and evaluable participants|||participants|||Number
1276544|NCT00301873|Secondary|Mean Change in Bone Mass Density (BMD)|Mean change in the combined t-score was measured by Dexa-scan. The patients bone density was determined by Dexa-scan at baseline, after 6 months Zometa and after 12 months of Zometa. The t-score, which is a comparison of a person’s bone density with that of a healthy 30-year old of the same sex, was generated by Dexa-scan for the spine and femur. A lower t-score implies a lower BMD. The combined t-score is the minimum of the t-score for the spine and that for the femur. BMD change from baseline at 6 and 12 months in the combined t-score was defined as the follow-up combined t-score minus the baseline combined t-score.|6 & 12 months|59 patients were accrued to the study; however follow-up at 6 months was available from 27 patients and at 12 months data was available from 19 patients.|||T score units||Standard Deviation|Mean
1276545|NCT00301873|Secondary|Skeletal-related Complications|Number of patients who experience skeletal-related complications during the administration of Zoledronate.|1 year|All patients.|||participants|||Number
1276546|NCT00301873|Primary|Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5.|Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person’s bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.|6 and 12 months|59 patients were accrued; however only 27 had a follow-up assessment at 6 months and 19 at 12 months.|||percentage of patients|||Number
1276547|NCT00301834|Secondary|Disease-free Survival With Correction of Disease at One Year Post Transplantation|"Patients deemed alive and well at follow-up timepoint later than 1-year post-transplantation"|1 year post-transplantation||||participants|||Number
1276548|NCT00301834|Secondary|Cytomegalovirus (CMV) Viral Infection and Disease Symptoms|polymerase chain reaction testing for presence of CMV weekly until at least day +100 then every 2 weeks until T-cell reconstitution as defined by cluster of differentiation 4 (CD4) > 200 cells/mm3. Median time to T-cell reconstitution was 6 months.|Up to one year post-transplant|4 participants were incapable of producing Ab or CMV testing result was indeterminate|||participants|||Number
1276549|NCT00301834|Secondary|Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation||1 year post-transplantation||||participants|||Number
1276550|NCT00301834|Secondary|Treatment-related Mortality at 100 Days and 1 Year Post Transplantation||100 days and 1 year||||participants|||Number
1276551|NCT00301834|Primary|Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation|Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences|6 weeks post-transplant|Participants evaluable for engraftment 6 weeks post-transplant; 1 patient died of transplant-related hemorrhage prior to 6 weeks and was not evaluated for this outcome|||participants|||Number
1276552|NCT00301821|Secondary|Overall Response Rate (ORR)|Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.|Baseline to first 6 cycles of treatment|Out of the 107 patients enrolled, Twenty-five patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.|||percentage of participants|||Number
1276553|NCT00301821|Secondary|Progression-free Survival (PFS)|Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.|the time from study entry to 36 months|Intent To Treat (All Patients)|||percentage of participants|||Number
1276554|NCT00301821|Secondary|Overall Survival|Percentage of participants alive at different time points|time from study entry to 36 months|Intent To Treat (All Patients)|||percentage of Participants|||Number
1276555|NCT00301821|Primary|Event-free Survival After 12 Months|The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).|From Baseline to 12 months|First 76 eligible participants were included in this analysis.|||percentage of participants|||Number
1276556|NCT00301808|Secondary|Toxicity|Toxicity: total number of SAEs and other AEs|72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year||||Adverse event|||Number
1276557|NCT00301808|Secondary|Overall Survival|Overall survival using Kaplan-Meier estimates|Date of registration to the date of death||||months||95% Confidence Interval|Median
1276558|NCT00301808|Secondary|Progression-free Survival|Progression-free survival using Kaplan-Meier estimates|Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.||||months||95% Confidence Interval|Median
1276559|NCT00301808|Primary|Probability of Overall Survival at One Year|Overall Survival at one year using Kaplan-Meier product-limit analysis|at 1 year||||probability of overall survival at 1 yr.||95% Confidence Interval|Number
1276560|NCT00301756|Other Pre-specified|Relationship Between Clinical and Pharmacodynamic Effects of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors|Summarized using summary statistics, such as the mean, median, and range. Tested using one-sample t-tests or Wilcoxon rank sum tests. Logistic regression analysis will be used to test significance.|Up to 5 years|||||||
1276561|NCT00301756|Secondary|Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Epithelial Ovarian Cancer Group)|Stable disease rate, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.|Up to 5 years|18 patients from Epithelian Ovarian Cancer patients were analyzed|||participants|||Number
1276562|NCT00301756|Secondary|Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group)|Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.|Up to 5 years||||months||95% Confidence Interval|Median
1276563|NCT00301756|Secondary|Number of Grade 3 Adverse Events Using the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Events of Thrombosis, Hypersensitivity and ALP will be tabulated.|Up to 5 years|18 patients with Epithelial ovarian cancer (EOC) and 14 patients with Micro-papillary ovarian tumor (LMP)|||events|||Number
1276564|NCT00301756|Secondary|Overall Survival|Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 5 years|Data were not collected||||||
1276566|NCT00301756|Secondary|Duration of Response|Summarized using summary statistics, such as the mean, median, counts and proportion. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|No participants had an objective response out of the 32 patients analyzed.||||||
1276567|NCT00301756|Secondary|Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Low Malignant Potential Group)|Stable disease rate, defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive disease, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.|Up to 5 years|14 patients with Low Malignant Potential tumours or Micropapillary / borderline were analyzed|||participants|||Number
1276568|NCT00301756|Secondary|Time to Disease Progression (Epithelial Ovarian Cancer Group)|Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.|Up to 5 years|Eighteen patients with Epethelial Ovarian Cancer were analyzed|||months||95% Confidence Interval|Median
1276569|NCT00301756|Primary|Efficacy of Belinostat in Terms of Complete or Partial Response; Disappearance of All Target Lesions or at Least a 30% Decrease in the Sum of the Longest Diameter of Target Lesions, Taking as Reference the Baseline Sum LD|Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria.|Up to 5 years||||participants|||Number
1276570|NCT00301418|Secondary|Overall Survival (OS)||Duration of the trial||||days||95% Confidence Interval|Median
1276571|NCT00301418|Secondary|6-month Progression Free Survival (PFS)||Duration of the trial||||days||95% Confidence Interval|Median
1276572|NCT00301418|Primary|Safety of Twice a Day Oral 150 mg Erlotinib Dosing|Greater than or equal to Grade 2 Adverse Event|duration of the trial||||participants|||Number
1276573|NCT00301366|Primary|Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion.|An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product. The adverse event does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the medicinal product.|24 weeks|38 subjects received study medication and one subject discontinued from the study due to an AE. Therefore, 37 subjects completed the study. 18 subjects were naive ((i.e., never having received previous Alpha-1 protease inhibitor augmentation therapy) and 19 subjects were non-naive.|||Participants|||Number
1276574|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections|Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276575|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4|Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276576|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4|Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276577|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3|Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276578|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2|Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276579|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1|Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276597|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Firmness|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
1276580|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0|Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276581|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4|Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276582|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4|Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276583|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3|Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276584|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2|Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276585|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1|Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <= Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276586|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0|Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276587|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for GEQ3|GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 3 under the treatment.|||subjects|||Number
1276588|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for GEQ2|GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 2 under the treatment.|||subjects|||Number
1276589|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1|GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 1 under the treatment.|||subjects|||Number
1276590|NCT00301262|Secondary|Analog Scales- General Sexual Performance|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
1276591|NCT00301262|Secondary|Analog Scales- Reliability|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
1276592|NCT00301262|Secondary|Analog Scales- Maintenance|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
1276593|NCT00301262|Secondary|Analog Scales- Firmness|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
1276594|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- General Sexual Performance|mean change - scale of 0 (worst) to 10 (best)|baseline to week 8|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
1276595|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Reliability|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
1276596|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Maintenance|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
1276598|NCT00301262|Secondary|Percentage of Occasions of Ejaculation and/or Orgasm Event Log|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Week 8 to Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276599|NCT00301262|Secondary|Percentage of Occasions of Successful Intercourse (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Week 8 to Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276600|NCT00301262|Secondary|Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to Week 8|number of subjects in the FAS population with an observation|||Percentage of occasions||Standard Deviation|Mean
1276601|NCT00301262|Secondary|Percentage of Occasions of Successful Intercourse (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to Week 8|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
1276602|NCT00301262|Secondary|Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.|Week 8, Week 14|number of subjects in the FAS population with an observation|||percentage of subjects|||Number
1276603|NCT00301262|Secondary|Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering “Yes”. % of responders/non-responders was calculated based on subjects who attempted intercourse.|Week 8, Week 14|number of subjects in the FAS population with an observation|||percentage of subjects|||Number
1276604|NCT00301262|Secondary|Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering “Yes”. % of responders/non-responders was calculated based on subjects who attempted intercourse.|Week 8, Week 14|number of subjects in the FAS population with an observation|||percentage of subjects|||Number
1276605|NCT00301262|Secondary|Quality of Erection Questionnaire (QEQ) Total Score|QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).|Week 8, Week 14|Full Analysis Set|||scores on a scale||Standard Deviation|Mean
1276606|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score|adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276607|NCT00301262|Secondary|Erectile Distress Scale (EDS) Total Score|Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
1276608|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score|adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276609|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction|Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
1276610|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction|Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
1276611|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire|Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
1276612|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function|Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
1276613|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Erectile Function|Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
1276614|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction|adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276615|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction|adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276616|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire|adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276617|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function|adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276618|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function|adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276619|NCT00301262|Secondary|Patient Reported Erectile Function Assessment (PREFA) Total Score|PREFA Total Score: 8 = worst, 32 = best.|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
1276620|NCT00301262|Secondary|Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score|adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276621|NCT00301262|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index|Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
1276622|NCT00301262|Primary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)|adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).|Week 8|number of subjects in the Full Analysis Set (FAS) population with an observation|||scores on a scale||Standard Error|Least Squares Mean
1276623|NCT00301080|Secondary|Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment|Record the amount of opioid medication used by patients in each arm before and after the study treatment period.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
1276624|NCT00301080|Secondary|Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane|Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
1276625|NCT00301080|Secondary|Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.|Compare changes in neuropathic pain scores within each arm, as well as between the 3 arms of the study. Neuropathic pain will be assessed using 3 tools: the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
1276626|NCT00301080|Secondary|Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period|Compare individual patients' self-reported pain relief scores before and after the treatment period.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
1276627|NCT00301080|Primary|Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory|Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
1276628|NCT00301067|Post-Hoc|Overall Survival (OS) Stratified by Vitamin D-Receptor (VDR) Gene Polymorphisms|Investigate the relationship between vitamin D-receptor (VDR) gene polymorphisms in Taq1 and Fok1 (analyzed from baseline blood sample) and Overall Survival (OS). VDR gene analysis was completed using PCR-RFLP based assays.|at baseline and until death from any cause up to 6 and half years|Cohort results for this outcome measure are combined as the objective was to determine the relationship between VDR gene polymorphisms and OS for patients with this drug combination (dose was irrelevant)|||Months||Inter-Quartile Range|Median
1276629|NCT00301067|Post-Hoc|Overall Survival|Overall Survival (OS) will be measured from first day of treatment until death of any cause. Patients still alive at the last data cut off point will be censored.|From the first day of treatment until death from any cause, up to a maximum of 6 and half years|Cohort results for this outcome measure are combined as the objective was to determine the OS of patients with this drug combination (dose was irrelevant)|||Months||Inter-Quartile Range|Median
1276630|NCT00301067|Post-Hoc|Time to Progression|Time to progression (TTP) is measured from the start of treatment until the time of first documentation of disease progression.|From the start of treatment, until progressive disease, up to 12 months|Cohort results for this outcome measure are combined as the objective was to determine the TTP for patients with this drug combination (dose was irrelevant)|||Months||Inter-Quartile Range|Median
1276631|NCT00301067|Post-Hoc|Overall Response Rate|"Overall Response Rate (ORR) is defined as percentage of patients who's best response to treatment is complete response plus those with partial response.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|From the start of treatment, every 2 cycles where 1 cycle equals 28 days, for a maximum of 12 cycles|Cohort results for this outcome measure are combined as the objective was to determine the ORR of patients with this drug combination (dose was irrelevant)|||Participants|||Count of Participants
1276632|NCT00301067|Secondary|The Relationship Between Vitamin D-receptor Gene Polymorphisms and Tumor Response|Investigate the relationship between vitamin D-receptor (VDR) gene polymorphisms in Taq1 and Fok1 (analyzed from baseline blood sample) and tumor response. VDR gene analysis was completed using PCR-RFLP based assays.|Baseline and at disease progression or when patient goes off study up to a maximum of 12 months|Cohort results for this outcome measure are combined as the objective was to investigate relationship of VDR gene polymorphisms present and tumor response of patients with this drug combination (dose was irrelevant) Data was not collected or analyzed for this outcome measure.||||||
1276633|NCT00301067|Secondary|Tumor Response|"Determine best tumor response during treatment. Response and progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up.~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|At baseline and every 8 weeks during treatment for a maximum of 12 cycles where one cycle equals 28 days.|Cohort results for this outcome measure are combined as the objective was to determine the tumor response of patients with this drug combination (dose was irrelevant)|||Participants|||Count of Participants
1276634|NCT00301067|Primary|Number of Patients With Toxicity|"Toxicity will be assessed for each patient on a seven-day on/seven-day off temozolomide in combination with high-dose calcitriol for every 2 weeks for up to 12 cycles where 1 cycle equals 28 days. Toxicity will be assessed during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) and defined by any toxicity determined to be at least possibly related to either study drug (temozolomide or calcitriol).~In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~Grade 3 and grade 4 toxicities where relatedness to either study drug could not be ruled out were collected and recorded only."|From the start of treatment and every 2 weeks for a maximum of 12 cycles, and 30 days post last treatment, where 1 cycle equals 28 days|All patients that receive one dose of study drug were evaluable for this outcome measure.|||participants|||Number
1276635|NCT00301067|Primary|Number and Frequency of Dose Limiting Toxicities (DLTs) With High-dose Calcitriol in Combination With Temozolomide|"Determine number and frequency of dose limiting toxicities (DLT) of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 cycles of therapy, where 1 cycle equals 28 days.~3 patients per dose cohort will be entered into the trial at doses of 0.2, 0.3, and 0.5 mcg/kg of calcitriol administered orally. If 1 patient experiences dose limiting toxicity (DLT) at any dose, that dose cohort will be expanded to a maximum of 6 patients. If 1 additional patient experiences DLT at that dose stratum, further dose escalation will cease and the dose cohort immediately preceding the dose cohort where the 2 experiences of DLT occurred will be considered the MTD. If no additional patients experience DLT, dose escalation to the next higher dose stratum will take place.~DLT is defined as National Cancer Institute Common Toxicity Criteria, version 3.0 grade 3 toxicity determined to be related to calcitriol."|From start of treatment, up to 12 cycles where 1 cycle equals 28 days|1 patient enrolled in cohort 1 was not evaluable for this outcome measure as the patient only received 8 days of treatment. Patients enrolled in the expansion cohort were not evaluable for this outcome measure.|||DLT|||Number
1276636|NCT00301028|Primary|Number of Participants With Complete Response|Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.|Study period of 3 Years||||participants|||Number
1276637|NCT00300885|Secondary|Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)|Lung Cancer Symptoms (LCS) subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). Cycle duration defined as 21 days. Change from baseline in LCS Subscale on day 1 of cycles 2 through 9 (weeks 4,7,10,13,16,19,22 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.|Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis|Evaluations of LCS Subscale based on the ITT population.|||Scores on a scale||Standard Deviation|Mean
1276638|NCT00300885|Secondary|Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)|"Functional Assessment of Cancer Therapy - Lung cancer subscore (FACT-L). Patient reported outcome as assessed by FACT-L score. FACT-L questionnaire comprises statements about physical, social / family, emotional and functional well-being as well as additional concerns which have to be rated by the patients (0=not at all to 4=very much). Cycle duration defined as 21 days. Change from baseline in Total FACT-L on day 1 of cycles 3,5,7,9 (weeks 7,13,19 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation."|Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis|Evaluations of Total FACT-L based on the ITT population.|||Scores on a scale||Standard Deviation|Mean
1277206|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1276639|NCT00300885|Secondary|Duration of Response|Duration of response (PR or better) is defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented).|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of duration of response based on the ITT population.|||days||95% Confidence Interval|Median
1276640|NCT00300885|Secondary|Overall Best Response|Best overall tumor response for the ITT population was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased).|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of overall best response rate based on the ITT population.|||percentage of participants|||Number
1276641|NCT00300885|Secondary|Progression Free Survival (PFS)|PFS determined as time (days) from the date of randomization at start of study to disease progression (radiological or clinical) or death due to any cause, if death occurs before progression.|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|PFS (based on the ITT population) for subjects without disease progression/death at the time of analysis were censored at the last evaluation date. PFS for surviving subjects without post-baseline tumor assessments were censored at one day. In the case of an incomplete date (missing day), day 15 (the middle of the month) will be used.|||days||95% Confidence Interval|Median
1276642|NCT00300885|Primary|Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.|Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of OS based on the ITT population. Subjects alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, if the day is missing, day 15 (the middle of the month) will be used.|||days||95% Confidence Interval|Median
1276643|NCT00300781|Secondary|Duration of Response|Number of weeks between Complete Response (CR) or Partial Response (PR) and the first date of disease progression (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|From start date of response to first PD/death, up to 46 months|Subjects in Intent to Treat population with CR or PR|||weeks||95% Confidence Interval|Median
1276644|NCT00300781|Secondary|Clinical Benefit Rate|Percentage of participants who experienced Complete Response (CR), Partial Response (PR), or Stable Disease (SD) ≥ 24 weeks by independent assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|From first dose date to progression or last tumor assessment, up to 46 months|Intent to Treat population|||percentage of participants||95% Confidence Interval|Number
1276645|NCT00300781|Secondary|Objective Response Rate|Percentage of participants with Partial Response (PR) or Complete Response (CR) by independent assessment of tumor per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From first dose date to progression or last tumor assessment, up to 46 months|Intent to Treat population|||percentage of participants||95% Confidence Interval|Number
1276646|NCT00300781|Primary|16-week Progression Free Survival|16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.|From first dose to 16 weeks|Intent to Treat Population|||percentage of participants||95% Confidence Interval|Number
1276647|NCT00300755|Secondary|"Number of Patients With Healed Erosive Esophagitis (EE) at End of Study"|Healed EE was defined as a modified Hetzel-Dent (HD) score <2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration).|8 weeks|The analysis population is randomized patients with erosive esophagitis at baseline.|||patients|||Number
1276648|NCT00300755|Secondary|Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline|Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.|Baseline and 8 weeks|The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Data were excluded if a patient answered a question <3 times in a week.|||units on scale||Standard Deviation|Mean
1276649|NCT00300755|Secondary|Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week|Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.|Baseline and 8 weeks|The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease.|||units on scale||Standard Deviation|Mean
1276650|NCT00300755|Primary|Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)|WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.|Baseline and 8 weeks|The primary efficacy population (mITT NERD) included all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Last observation carried forward (except for baseline data, which were not carried forward into the treatment period).|||units on scale||Standard Deviation|Mean
1276651|NCT00300742|Primary|Compliance With Study Requirements: Topiramate Level|Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day|up to 12 weeks|This is the number of participants who reached the dose of 300 mg of topiramate|||participants|||Number
1276652|NCT00300742|Primary|Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12|Mean binge eating episodes per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol|||Binge eating episodes/week||Standard Deviation|Mean
1276653|NCT00300742|Primary|Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12|Mean percent days abstinent per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol|||Mean percent days abstinent per week||Standard Deviation|Mean
1276654|NCT00300742|Primary|Mean Drinks Per Day at Baseline vs. Visit 12|Mean drinks per day at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol|||Drinks/day||Standard Deviation|Mean
1276655|NCT00300742|Primary|Compliance With Study Requirements: Attendance at Treatment Sessions||up to 12 weeks||||participants|||Number
1276656|NCT00300677|Primary|Brain Concentrations of N-oxide Metabolite|Mean brain concentrations (ng/mL) of voriconazole N-oxide metabolite pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).|||ng/mL||Standard Deviation|Mean
1276657|NCT00300677|Primary|Plasma Concentrations of N-oxide Metabolite|Mean plasma concentrations of voriconazole N-oxide metabolite (ng/mL) pre-dose and 2 hours post-dose. Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).|||ng/mL||Standard Deviation|Mean
1276658|NCT00300677|Primary|Brain Concentrations of Voriconazole|Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).|||ng/mL||Standard Deviation|Mean
1276659|NCT00300677|Primary|Plasma Concentrations of Voriconazole|Mean plasma voriconazole concentrations (nanograms per milliliter [ng/mL]) pre-dose (Cmin) and two hours post-dose (C2h). Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).|||ng/mL||Standard Deviation|Mean
1276660|NCT00300495|Secondary|Length of Post-operative Hospital Stay|Length of hospital stay after the operation|1 week on average||||Days||Standard Deviation|Mean
1276661|NCT00300495|Primary|Incidence of Post-operative Atrial Fibrillation|Number of patients with post-operative atrial fibrillation|30 days||||Participants|||Count of Participants
1276662|NCT00300482|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF|||percent change||Inter-Quartile Range|Median
1276663|NCT00300482|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline ApoB and at least 1 postbaseline ApoB value, LOCF|||percent change||Standard Error|Mean
1276664|NCT00300482|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF|||percent change||Standard Error|Mean
1276665|NCT00300482|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF|||percent change||Standard Error|Mean
1276666|NCT00300482|Secondary|Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF|||percent change||Standard Error|Mean
1276667|NCT00300482|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward|||percent change||Standard Error|Mean
1277813|NCT00291551|Secondary|Changes in Left Ventricular Volumes|Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol|||milliliters||Standard Deviation|Mean
1276668|NCT00300482|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward|||percent change||Standard Error|Mean
1276669|NCT00300482|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward|||percent change||Standard Error|Mean
1276670|NCT00300469|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF|||percent change||Inter-Quartile Range|Median
1276671|NCT00300469|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF|||percent change||Standard Error|Mean
1276672|NCT00300469|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF|||percent change||Standard Error|Mean
1276673|NCT00300469|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF|||percent change||Standard Error|Mean
1276674|NCT00300469|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF|||percent change||Standard Error|Mean
1276675|NCT00300469|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)|||percent change||Standard Error|Mean
1276676|NCT00300469|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline HDL-C value and at least 1 postbasline HDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)|||percent change||Standard Error|Mean
1276677|NCT00300469|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward (excluding one subject with an extreme outlying value)|||percent change||Standard Error|Mean
1276678|NCT00300456|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF|||percent change||Inter-Quartile Range|Median
1276679|NCT00300456|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF|||percent change||Standard Error|Mean
1276680|NCT00300456|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF|||percent change||Standard Error|Mean
1276681|NCT00300456|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF|||percent change||Standard Error|Mean
1276682|NCT00300456|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF|||percent change||Standard Error|Mean
1276683|NCT00300456|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward|||percent change||Standard Error|Mean
1276684|NCT00300456|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward|||percent change||Standard Error|Mean
1276685|NCT00300456|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward|||percent change||Standard Error|Mean
1276686|NCT00300430|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Full Range|Median
1276687|NCT00300430|Primary|Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study||Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or in this open-label study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.|||percentage of participants|||Number
1276688|NCT00300430|Secondary|Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
1276689|NCT00300430|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
1276690|NCT00300430|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
1276691|NCT00300430|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study||Baseline to Week 52 in this open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
1276692|NCT00300430|Secondary|Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
1276693|NCT00300430|Secondary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
1276694|NCT00300430|Secondary|Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Full Range|Median
1276695|NCT00300391|Secondary|ICU Length of Stay||Daily|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the “Delirium,” “Persistent Coma,” and “No delirium”.|||day||Inter-Quartile Range|Median
1276696|NCT00300391|Secondary|Duration of Mechanical Ventilation||daily|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the “Delirium,” “Persistent Coma,” and “No delirium”.|||day||Inter-Quartile Range|Median
1276697|NCT00300391|Primary|90-day All-cause Mortality||90 Days from enrollment in study|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the “Delirium,” “Persistent Coma,” and “No delirium”.|||Participants|||Count of Participants
1276698|NCT00300391|Primary|28-day All-cause Mortality||Daily|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the “Delirium,” “Persistent Coma,” and “No delirium”.|||Participants|||Count of Participants
1276699|NCT00300365|Primary|Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks|Mean increase in HDL-C from baseline (week -4) to 12 weeks post randomization in non-diabetic subjects with low HDL-C and metabolic syndrome. After baseline, all subjects titrated niacin extended release (ER) to 2 grams (g) daily over 4 weeks. Subjects were also given 325 mg aspirin to take 30 minutes before the niacin ER. After 4 weeks, half of the subjects added blinded pioglitazone 30mg/day (milligrams/day) for 6 weeks followed by 45 mg/day for 6 weeks; the other half added placebo. HDL-C was was assessed at baseline and 12 weeks post randomization|Baseline, after 12 weeks of pioglitazone vs placebo|All subjects for whom HDL-C measurements were recorded at baseline (week -4) and 12 weeks post randomization to placebo, niacin ER, and aspirin or pioglitazone, niacin ER, and aspirin|||mg/dL||95% Confidence Interval|Mean
1277814|NCT00291551|Secondary|Changes in Left Ventricular Diameters|Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol|||centimeters||Standard Deviation|Mean
1276700|NCT00300274|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24|"Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment."|24 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1276701|NCT00300274|Secondary|Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months|"GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R~C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1"|24 Months|Participants from the intent-to-treat population (all randomized participants) with data available for analysis.|||mL/min/1.73^2||Standard Deviation|Mean
1276702|NCT00300274|Secondary|Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months|Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window).|24 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1276703|NCT00300274|Secondary|Percentage of Participants With Composite Efficacy Failure at 24 Months|"Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.~Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment."|24 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1276704|NCT00300274|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12|"Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment."|12 Months|Intent-to-treat population includes all randomized participants.|||Percentage of participants|||Number
1276705|NCT00300274|Secondary|Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12|Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12.|12 Months|IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS centers).|||Percentage of participants|||Number
1276706|NCT00300274|Secondary|Change From Baseline in the Average Maximum Intimal Thickness at Month 12|Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery.|Baseline, Month 12|IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS Centers).|||mm||Standard Deviation|Mean
1276707|NCT00300274|Secondary|Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months|"GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1"|12 Months|Participants from the intent-to-treat population (all randomized participants) with data available for analysis.|||mL/min/1.73^2||Standard Deviation|Mean
1276708|NCT00300274|Secondary|Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months|Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window).|12 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1276709|NCT00300274|Primary|Percentage of Participants With Composite Efficacy Failure at 12 Months|"Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.~Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment."|12 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1276710|NCT00300235|Secondary|Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol|Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.|Cross-sectional single survey visit|||||||
1276711|NCT00300235|Secondary|Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies|Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.|Cross-sectional single survey visit|||||||
1276712|NCT00300235|Secondary|Characterization of Priapism in Males With Sickle Cell Anemia With Reference to Time of Onset, Duration of Events, Frequency of Episodes, Precipitating or Associated Activities, Treatment Modalities Used, and Outcome of Treatments|Characterization of priapism in males with sickle cell anemia with reference to time of onset, duration of events, frequency of episodes, precipitating or associated activities, treatment modalities used, and outcome of treatments.|Cross-sectional single survey visit|||||||
1276713|NCT00300235|Primary|Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.|"Subject responded YES to survey Question Have you ever had priapism?. By diagnosis and age group. Enumeration of the prevalence of priapism in males with sickle cell anemia and sickle beta zero thalassemia."|At time of interview|All particpants who completed survey were analyzed.|||participants|||Number
1276714|NCT00299975|Secondary|Serum Glutamic Oxaloacetic Transaminase(SGOT) Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
1276715|NCT00299975|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
1276716|NCT00299975|Secondary|Blood Creatinine Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||μmol/L||Standard Deviation|Mean
1276717|NCT00299975|Secondary|Blood Urea Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||mmol/L||Standard Deviation|Mean
1276718|NCT00299975|Secondary|Adverse Effects (e.g. Renal and Liver Function Tests)||pre-treatment & post-treatment|||||||
1276719|NCT00299975|Secondary|Passing of Gas|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1276720|NCT00299975|Secondary|Sensation of Abdominal Pain/Cramping|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1276721|NCT00299975|Secondary|Sensation of Bloating|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1276722|NCT00299975|Secondary|Incomplete of Evacuation|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1276723|NCT00299975|Secondary|Sensation of Straining|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1276724|NCT00299975|Secondary|Severity of Constipation|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1276725|NCT00299975|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Week6, 10 & 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1276726|NCT00299975|Secondary|Complete Spontaneous Bowel Movement (CSBM)|CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
1276727|NCT00299975|Secondary|Bowel Movement||Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
1276728|NCT00299975|Secondary|Responder for Complete Spontaneous Bowel Movement (CSBM)|Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Week11-18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1276729|NCT00299975|Primary|Responder for Complete Spontaneous Bowel Movement (CSBM)|Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Week3-10|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1276730|NCT00299741|Secondary|Objective Responses, Defined as the Number of Participants With Complete or Partial Response|The response rate is defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by radiographic evaluation. Complete response(CR): disappearance of all target lesions; Partial response(PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall response = CR + PR.|Participants were followed until the time of disease progression, an average of 12 weeks||||participants|||Number
1276731|NCT00299741|Primary|The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)|were followed until disease progression, an average of 12 weeks|All participants analyzed|||participants|||Number
1276732|NCT00299702|Primary|Time in Remission|Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6).|Day 1 to last PANSS measurement|explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.|||days||Standard Deviation|Mean
1276733|NCT00299702|Primary|Time to Relapse|Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.|Day 1 to relapse|explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.|||days||95% Confidence Interval|Median
1276734|NCT00299689|Secondary|Overall Survival||All cause mortality|||||||
1276735|NCT00299689|Primary|Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria||2 weeks after completion of second cycle||||participants|||Number
1276736|NCT00299546|Secondary|Health Assessment Questionnaire (HAQ) Score at Week 24|Improvement from baseline in HAQ score at Week 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.|From Baseline to Week 24|Randomized participants (excluding 1 site). Missing scores imputed by Last Observation Carried Forward. Week 16 scores were used for participants with change in study treatment.|||scores on a scale||Inter-Quartile Range|Median
1276737|NCT00299546|Secondary|American College of Rheumatology (ACR) 20 at Week 24|Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)|From Baseline to Week 24|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components imputed by LOCF unless all components were missing; in which case considered non-responders. Wk 16 ACR response used for change in study tx.|||participants|||Number
1276738|NCT00299546|Secondary|Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14|DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant’s global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst).|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing DAS 28 components imputed by Last Observation Carried Forward unless all components were missing; in which case considered non-responders.|||participants|||Number
1276739|NCT00299546|Secondary|American College of Rheumatology (ACR) 50 Response at Week 14|Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||participants|||Number
1276740|NCT00299546|Primary|American College of Rheumatology (ACR) 20 Response at Week 14.|ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||participants|||Number
1276797|NCT00299221|Secondary|Mean ISHLT Biopsy Score Over First Year Post-transplant|Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.|1 year|all pts, Intention to treat|||units on a scale||Standard Deviation|Mean
1276741|NCT00299494|Secondary|Steady-state Volume (Vss) of Inotuzumab Ozogamicin Antibody Distribution in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Vss: Steady-state volume of distribution CL*MRT of inotuzumab ozogamicin Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L||Geometric Coefficient of Variation|Geometric Mean
1276742|NCT00299494|Secondary|Clearance (CL) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Clearance defined as Dose/AUCinf. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK populatoin|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1276743|NCT00299494|Secondary|Minimum Observed Serum Trough Concentration (Cmin) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cmin: Lowest concentration observed during the dosing interval tau. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276744|NCT00299494|Secondary|Average Serum Concentration (Cav) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cav: AUCtau/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276745|NCT00299494|Secondary|Time to Reach Maximum Concentration (Tmax) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276746|NCT00299494|Secondary|Peak Concentration (Cmax) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276747|NCT00299494|Secondary|Area Under the Steady-state Serum Concentration-time Curve (AUCtau) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD+ Rituximab 375 mg/m^2 on Dosing Day 1, Day 30, and Day 58|AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276748|NCT00299494|Secondary|Serum Decay Half-Life (t1/2) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab on Dosing Day 30 and Day 58|"Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.~Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3."|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276749|NCT00299494|Secondary|Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276759|NCT00299494|Secondary|Steady-state Volume (Vss) of Total Calicheamicin (Conjugated Plus Unconjugated) Distribution in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Vss: Steady-state volume of distribution CL*MRT of inotuzumab ozogamicin Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L||Geometric Coefficient of Variation|Geometric Mean
1276750|NCT00299494|Secondary|Area Under the Steady-state Concentration-time Curve (AUClast) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276751|NCT00299494|Secondary|Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m2 on Dosing Day 30 and Day 58|AUCinf: AUClast+(Clast/kel) where Clast is the predicted serum concentration at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276752|NCT00299494|Secondary|Minimum Observed Serum Trough Concentration (Cmin) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin+Rituximab on Dosing Day 30 and Day 58|Cmin: Lowest concentration observed during the dosing interval tau. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276753|NCT00299494|Secondary|Time of Observed Maximum Concentration (Tmax) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin + Rituximab on Dosing Day 1, Day 30 and Day 58|Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276754|NCT00299494|Secondary|Peak Serum Concentration (Cmax) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276755|NCT00299494|Secondary|Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276756|NCT00299494|Secondary|Area Under the Steady-state Serum Concentration-time Curve (AUClast) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276757|NCT00299494|Secondary|Serum Decay Half-Life (t1/2) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|"Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.~Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3."|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|Pk population|||hr||Full Range|Median
1276758|NCT00299494|Secondary|Mean Residence Time (MRT) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|MRT: AUMCinf/AUCinf – DOF/2, where AUMCinf is the area under the first moment curve derived using the linear/log trapezoidal method, and DOF is the duration of the IV infusion dose. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Geometric Coefficient of Variation|Geometric Mean
1276798|NCT00299221|Secondary|Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant|Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant|1 year|Percent of patients with allograft CAD at one year post-transplant|||patients|||Number
1276760|NCT00299494|Secondary|Clearance (CL) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Clearance defined as Dose/AUCinf. Corresponds to Dosing Day 30 for Cycle 2 and dosing Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1276761|NCT00299494|Secondary|Minimum Observed Serum Trough Concentration (Cmin) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cmin: Lowest concentration observed during the dosing interval tau. Observed directly from data from Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276762|NCT00299494|Secondary|Average Serum Concentration (Cav) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cav: AUCtau/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276763|NCT00299494|Secondary|Time of Observed Maximum Concentration (Tmax) of Total Calicheamicin (Conjugated+Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|"Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence.~Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3."|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276764|NCT00299494|Secondary|Peak Serum Concentration (Cmax) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276765|NCT00299494|Secondary|Area Under the Steady-state Serum Concentration-time Curve (AUCtau) for Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30, and Day 58|AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276766|NCT00299494|Secondary|Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276767|NCT00299494|Secondary|AUClast of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||n*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276768|NCT00299494|Secondary|AUCinf of Total Calicheamicin (Conjugated + Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|AUCinf: AUClast+(Clast/kel) where Clast is the predicted serum concentration at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276799|NCT00299221|Secondary|Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant|Number of patients developing cytomegalovirus disease by 1 year post-transplant|1 year|all patients|||participants|||Number
1276769|NCT00299494|Secondary|Serum Decay Half-Life (t1/2) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|"Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.~Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3."|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276770|NCT00299494|Secondary|MRT of Inotuzumab Ozogamicin in Serum in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|MRT: AUMCinf/AUCinf – DOF (degrees of freedom)/2, where AUMCinf is the area under the first moment curve derived using the linear/log trapezoidal method, and DOF is the duration of the IV infusion dose. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Geometric Coefficient of Variation|Geometric Mean
1276771|NCT00299494|Secondary|Steady-state Volume of Distribution (Vss) of Inotuzumab Ozogamicin in Serum in Participants Receiving Inotuzumab MTD+Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Vss of inotuzumab ozogamicin on Dosing Days 30 and 58 were reported. Vss=CL*MRT (mean residence time). Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L||Geometric Coefficient of Variation|Geometric Mean
1276772|NCT00299494|Secondary|Clearance (CL) of Serum Inotuzumab Ozogamicin in Participants Receiving Inotuzumab+Rituximab on Dosing Day 30 and Day 58|Clearance is defined as Dose/AUCinf. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1276773|NCT00299494|Secondary|Minimum Observed Serum Trough Concentration (Cmin) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab+Rituximab on Dosing Day 30 and Day 58|Cmin: Lowest concentration observed during the dosing interval tau. Observed directly from data from Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276774|NCT00299494|Secondary|Average Serum Concentration at Steady State (Cav) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cav: AUCtau (Area under the concentration time profile)/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276775|NCT00299494|Secondary|Time to Reach Maximum Concentration (Tmax) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276776|NCT00299494|Secondary|Peak Serum Concentration (Cmax) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30, and 58 were measured. Cmax of inotuzumab ozogamicin was reported. Cmax was observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1276777|NCT00299494|Secondary|Area Under the Steady-state Serum Concentration-time Curve (AUCtau) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Steady-state serum concentrations of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUCtau of inotuzumab ozogamicin was reported. AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276785|NCT00299494|Secondary|Kaplan-Meier Estimates of Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From the first dose up to 5 years post last dose|ITT population. Calculated using Kaplan-Meier method.|||Months||95% Confidence Interval|Median
1276778|NCT00299494|Secondary|Time of the Last Quantifiable Serum Concentration in a Dosing Interval (Tlast) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tlast of inotuzumab ozogamicin on Dosing Days 1, 30, and 58 was reported. Tlast: Time of last quantifiable concentration of inotuzumab ozogamicin. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
1276779|NCT00299494|Secondary|AUClast of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUC of inotuzumab ozogamicin was reported. AUClast is area under the serum concentration-time profile from time zero to the time of the Clast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population: all participants dosed with inotuzumab ozogamicin.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1276780|NCT00299494|Secondary|Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Serum concentration of inotuzumab ozogamicin on Dosing Days 30 and 58 were measured. AUCinf of inotuzumab ozogamicin was reported. AUCinf: AUClast (area under the serum concentration-time profile for inotuzumab ozogamicin from time zero to the time of the last quantifiable concentration) +(Clast [last quantifiable concentration]/kel [elimination rate constant]) where Clast is the predicted serum concentration of inotuzumab ozogamicin at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
1276781|NCT00299494|Secondary|Duration of Response (CR+CRu+PR)|Time from date measurement criteria met for CR, CRu, or PR (whichever occurred first) until first date relapsed disease/date of death. CR: Complete disappearance of all detectable clinical, radiographic evidence of disease, disease-related symptoms, normalization of NHL assignable biochemical abnormalities; lymph nodes, nodal masses regressed to normal size; spleen size regressed, not palpable on physical exam, size of other organs enlarged due to disease. CRu: CR but allows for: residual lymph node mass >1.5 cm in greatest transverse diameter that regressed >75% in product diameter. Individual nodes previously confluent, regressed by >75% in their product diameters; Indeterminate bone marrow. PR: ≥50% decrease in SPD of 6 largest dominant nodes/nodal masses; No increase in size of other nodes, liver, or spleen; Splenic/hepatic nodules regressed by ≥50% in SPD; Except splenic/hepatic nodules, involvement of other organs assessable and no measurable disease present.|Time from date measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the first date relapsed disease or date of death (whichever occurs first) is objectively documented.|ITT population. Calculated using Kaplan-Meier method using the number of participants that responded.|||Month||95% Confidence Interval|Median
1276782|NCT00299494|Secondary|Kaplan-Meier Estimates of the Probability of Being Event Free at 6 Months|Time-to-Tumor Progression (TTP): is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by >=50% in the size of previously involved sites, c. >= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. >= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver. The Kaplan-Meier method was used to determineTTP. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From enrollment to up to 6 months from 1st dose.|ITT population. Calculated using Kaplan-Meier method.|||Probability||95% Confidence Interval|Number
1276783|NCT00299494|Secondary|Kaplan-Meier Estimates of Time to Tumor Progression (TTP)|TTP is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by >= 50% in the size of previously involved sites, c. >= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. >= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver. The Kaplan-Meier method was used to determine TTP. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From the date of first dose of test article until the first date on which disease progression or death was documented, any of which could be reported up to 5 years post last dose.|ITT population. Calculated using Kaplan-Meier method.|||Months||95% Confidence Interval|Median
1276784|NCT00299494|Secondary|Kaplan-Meier Estimates of the Probability of Survival at 6 Months|Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From the first dose to 6 months after first dose.|ITT population. Calculated using Kaplan-Meier method.|||Probability||95% Confidence Interval|Number
1276800|NCT00299221|Secondary|Percent of Patients Alive at One Year Post-transplant|Percent of patients alive at one year post-transplant. In other words, all cause mortality over time|1 year|all pts, intention to treat|||percent of participants|||Number
1276786|NCT00299494|Secondary|Kaplan-Meier Estimates of the Probability of Being Progression Free at 6 Months|Progression Free Survival is defined as the time interval from the first dose of test article until the first date on which relapsed disease, progression, initiation of new anti-cancer treatment due to persistent/refractory disease, or death was documented, censored at the last tumor evaluation.|From the first dose to 6 months after first dose|ITT population; Calculated using Kaplan-Meier method.|||Probability||95% Confidence Interval|Number
1276787|NCT00299494|Secondary|Kaplan-Meier Estimates of Progression Free Survival (PFS)|The Kaplan-Meier method was used to determine PFS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by >= 50% in the size of previously involved sites, c. >= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. >= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver.|From the date of first dose of test article until the first date on which disease progression or death was documented or new anticancer start, any of which could be reported up to 5 years post last dose|ITT population. Calculated using Kaplan-Meier method.|||Months||95% Confidence Interval|Median
1276788|NCT00299494|Secondary|Percentage of Participants With Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)|CR: a. Complete disappearance of all detectable clinical and radiographic evidence of disease, disease-related symptoms, and normalization of NHL assignable biochemical abnormalities ; b. lymph nodes and nodal masses must have regressed to normal size; c. Spleen regressed in size and not palpable on physical exam, size of other organs enlarged due to disease decreased in size; d. Repeat bone marrow infiltrate clear. CRu: CR but allows for a. Residual lymph node mass >1.5 cm in greatest transverse diameter has regressed by more than 75% in diameter. Individual nodes that were previously confluent regressed more than 75 % in their product diameters; b. Indeterminate bone marrow. PR: a. ≥50 % decrease in product of the diameters (SPD) of the 6 largest dominant nodes or nodal masses; b. No increase in size of other nodes, liver, or spleen, c. Liver or spleen nodules regressed ≥50% in the SPD; d. Other organs usually assessable, no measurable disease present.|Approximately every 2 (during treatment) or 3 (during follow-up) to 6 months for up to 5 years from 1st dose|ITT population: all participants enrolled into the intended dose scheme. Using exact method based on binomial distribution.|||Percentage of participants||95% Confidence Interval|Number
1276789|NCT00299494|Primary|Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)|A TEAE is any event that occurred after the first dose of study drug up to 56 days post the last dose of study drug (either rituximab or inotuzumab ozogamicin).|Protocol reporting period of from informed consent to at least 28 days after the last dose. This outcome measure time frame: From the first dose of study drug to up to 56 days after the last dose of either study drug.|Safety population: All participants receiving at least 1 dose of inotuzumab ozogamicin or rituximab.|||Percentage of participants|||Number
1276790|NCT00299494|Primary|Maximum Tolerated Dose (MTD) of Inotuzumab Ozogamicin in Combination With Rituximab (375 mg/m^2 )|Inotuzumab ozogamicin was dose escalated (3 to 6 evaluable participants enrolled per dose cohort) during the first 28 days after the first administration of inotuzumab ozogamicin + rituximab. Enrollment at the next dose level or enrollment of additional subjects into a cohort proceeded according to the following criteria: 0 dose-limiting toxicity (DLT) by Day 28 of first dose move to higher dose, 1 participant reporting DLT but no others in cohort by Day 28 of first dose move to higher dose, greater than 2 participants reporting DLT by Day 28 of first dose stop and prior dose level considered MTD. The worldwide medical monitor and investigators reviewed all significant study drug-related toxicities to determine if the dose escalation rules were satisfied and whether the dose escalation schedule required modification.|First 28-day cycle|Intent-To-Treat (ITT) Population: All participants included in the intended dose scheme. One additional participant was enrolled over the 6 planned participants in 1.8 mg/m^2 dose cohort because 1 participant was unevaluable for MTD evaluations.|||mg/m^2|||Number
1276791|NCT00299416|Primary|Number of Participants With Cardiorespiratory Failure|The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.|every 30 minutes during hypothermia induction||||participants|||Number
1276792|NCT00299416|Primary|Number of Participants With Catheter Related Complications During Hypothermia & Rewarming|Catheter-related complications assessed whether participants had bleeding (major hemorrhaging) that required a blood transfusion, this was determined by labs. Participants were monitored for infections every hour during vital signs in the 24 hour hypothermia phase and 12 hour rewarming phase.|over 36 hour period||||participants|||Number
1276793|NCT00299416|Secondary|Efficacy: NIHSS < 2 at 24 Hours, Modified Rankin Scale (mRS) < 2 at 3 Months, NIHSS < 2 at 3 Months, and Length of Hospital and ICU Stay.|NIHSS score of ≤ 2 24 hours after stroke onset modified Rankin Scale (mRS) < 2 at 90 day followup NIHSS score of ≤ 2 at daily duration of hospitalization and ICU stay and 90 day follow up.|90 days|||||||
1276794|NCT00299416|Secondary|Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.||rewarming over 12 hours until 36.5C has been achieved|||||||
1276795|NCT00299416|Secondary|Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,|Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.|rewarming over 12 hours until 36.5C has been achieved|||||||
1276796|NCT00299416|Primary|Number of Participants With Symptomatic Intracerebral Hemorrhage|Symptomatic intracerebral hemorrhages were measured by a full NIHSS(National Institute of Health Stroke Scale) prior to caffeinol & hypothermia,at the end of hypothermia & rewarming, 24 hrs after stroke onset, daily during hospitalization,& at the 90 day follow-up visit. In addition, modified NIHSS were done hourly during the 24 hr hypothermia period & 12 hr rewarming period. At the end of rewarming an MRI was obtained to verify if hemorrhages or neurologic deteriorations were present.NIHSS scores severity of stroke on 11 items;more points given for greater deficiencies(range 0-42,0=normal)|from pre-dosage to 90 day followup|Number of participants were determined by intention to treat. We did not use any imputation technique.|||participants|||Number
1286685|NCT00168831|Secondary|Change From Baseline in Lymphocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1276801|NCT00299221|Primary|Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation|Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.|6 months|all pts, intention to treat|||units on a scale||Standard Deviation|Mean
1276802|NCT00299156|Primary|Participants With a Complete Remission (CR)|"Complete Remission (CR): Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L).~Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment.~Hematologic Improvement: meets all criteria for CR except for platelet recovery to >100 x 109/L.~Clinical Benefit: Platelets increase by 50% and to above 30 x 109/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 109/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 109/L."|After 3 courses of treatment, up to 24 weeks.||||Participants|||Number
1276803|NCT00299130|Post-Hoc|Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment|A low immunoglobulin concentration was defined as a concentration below the lower level of normal.|Baseline (pre-rituximab), Beginning of the safety follow-up period to the end of the study (approximately 6 years) (post-rituximab)|"Safety follow-up population: All participants who were randomized and received any part of a rituximab infusion. Number of participants analyzed = participants with available data. N indicates the number of participants with non-missing data at each time point."|||Percentage of participants|||Number
1276804|NCT00299130|Post-Hoc|Time to Repletion of Peripheral CD19+ B-cells|Peripheral CD19+ B-cell repletion was defined as a CD19+ B-cell count that returned to the Baseline value or returned to ≥ the lower limit of normal, whichever was lower.|Beginning of the first infusion (Day 1) in the last treatment cycle until repletion or the end of the study (approximately 6.5 years)|Extended safety follow-up population: All participants who were randomized, received any part of a rituximab infusion, and entered the extended safety follow-up period.|||Weeks||95% Confidence Interval|Median
1276805|NCT00299130|Secondary|Percentage of Participants With an ACR70 Response at Week 48|"To achieve an ACR70 required at least a 70% improvement compared with baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 48|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
1276806|NCT00299130|Secondary|Percentage of Participants With an ACR50 Response at Week 48|"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 48|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
1276807|NCT00299130|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.~Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6."|Week 48|Intent to treat population including participants with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.|||percentage of participants|||Number
1276808|NCT00299130|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher."|Baseline and Week 48|Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Patients who withdrew prior to week 48, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.|||percentage of participants|||Number
1276809|NCT00299130|Secondary|Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.~Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.~An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.~A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22."|Baseline and Week 48|Intent-to-treat population including participants with available data. LOCF was used.|||percentage of participants|||Number
1276810|NCT00299130|Secondary|Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.~Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.~An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.~A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22."|Baseline and Week 24|Intent-to-treat population including participants with available data. LOCF was used.|||percentage of participants|||Number
1276811|NCT00299130|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.~Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6."|Week 24|Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing. Number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1276812|NCT00299130|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores|"The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276813|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276814|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276815|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276816|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276921|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 96|Biochemically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276817|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276818|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276819|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276820|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
1276821|NCT00299130|Secondary|Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A positive percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1276822|NCT00299130|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate|"Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1276823|NCT00299130|Secondary|Percent Change From Baseline in C-Reactive Protein|"C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1276824|NCT00299130|Secondary|Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1276825|NCT00299130|Secondary|Percent Change From Baseline in Physician’s Global Assessment of Disease Activity|"The physician’s assessment of the participant's current disease activity on a 100 mm horizontal VAS, where the left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1283069|NCT00233090|Secondary|Health Status|health status|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
1276826|NCT00299130|Secondary|Percent Change From Baseline in Patient’s Pain Assessment|"The participant’s assessment of their current level of pain on a 100 mm horizontal visual analog scale (VAS), where the left-hand extreme of the line (0 mm) was described as no pain and the right-hand extreme (100 mm) as unbearable pain.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1276827|NCT00299130|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity|"The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity).~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1276828|NCT00299130|Secondary|Percent Change From Baseline in Tender Joint Count|"Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1276829|NCT00299130|Secondary|Percent Change From Baseline in Swollen Joint Count|"Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
1276830|NCT00299130|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1."|Baseline and Week 24|Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Participants who withdrew prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.|||percentage of participants|||Number
1276831|NCT00299130|Secondary|Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6."|Baseline and Week 24|Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.|||scores on a scale||Standard Deviation|Mean
1276832|NCT00299130|Secondary|Percentage of Participants With an ACR70 Response at Week 24|"To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
1276840|NCT00299104|Secondary|Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52|"MCID is defined as a change from baseline in SF-36 Mental Health Component Score of >6.33.~SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Baseline, Week 52|Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.|||Percentage of Participants|||Number
1276833|NCT00299130|Secondary|Percentage of Participants With an ACR50 Response at Week 24|"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
1276834|NCT00299130|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24|"To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population included all randomized participants who received at least 1 or part of an infusion. ACR was calculated using the last observation carried forward (LOCF) values for each component. Participants who withdrew prior to week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
1276835|NCT00299104|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 104|Participants from the Intent-to treat Population includes all randomized participants who received at least one dose of study drug with data at baseline and Week 104 available for analysis. Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1276836|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104|"Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The score at baseline is compared to the score at week 104.~No progression is defined as a change from score at screening to week 104 ≤0."|Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing.|||Percentage of Participants|||Number
1276837|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression at Week 104|Percentage of patients without radiographic progression at Week 104, defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 104|Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing|||Percentage of Participants|||Number
1276838|NCT00299104|Secondary|Change From Baseline in the Total Erosion Score at Week 104|Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The change from the score at baseline to week 104 is calculated.|Baseline, Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and who had both screening and post-baseline radiographic assessments at the given time point for analyses. Linear extrapolation used for missing data.|||Score on a scale||Standard Deviation|Mean
1276839|NCT00299104|Secondary|Change From Baseline in the Modified Total Sharp Score at Week 104|The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time-point for analysis. Linear extrapolation was used for missing data.|||Score on a scale||Standard Deviation|Mean
1276857|NCT00299104|Secondary|Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24|Joint Space Narrowing is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.|Baseline, Week 24|Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) with data available at Week 24 for analysis.|||Score on a scale||Standard Deviation|Mean
1276841|NCT00299104|Secondary|Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52|"MCID is defined as a change from baseline in SF-36 Physical Health Component Score of >5.42.~SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Baseline, Week 52|Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.|||Percentage of Participants|||Number
1276842|NCT00299104|Secondary|Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52|"The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction.~Improved:HAQ-DI score change <=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score => 0.22"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward.|||Percentage of participants|||Number
1276843|NCT00299104|Secondary|Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104|"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.~Means are adjusted for baseline value, Rheumatoid Factor status and region."|Baseline, Weeks 52, Week 104|"Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward. n in each of the categories is the number of participants with data available for analyses at the given time point."|||Score on a scale||Standard Deviation|Mean
1276844|NCT00299104|Secondary|Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104|"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.~Means are adjusted for baseline value, Rheumatoid Factor status and region."|Baseline, Week 52, Week 104|"Intent to treat (ITT) population includes all participants who received at least one infusion. Last observation carried forward. n in each of the categories is the number of participants with data available for analyses at the given time point."|||Score on a scale||Standard Deviation|Mean
1276845|NCT00299104|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 52|Intent-to treat Population includes all randomized participants who received at least one dose of study drug. Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1276846|NCT00299104|Secondary|Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Observed data.|||Score on a scale||Standard Deviation|Mean
1276847|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52|"To achieve an ACR90 response requires at least a 90% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 90% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).|||Percentage of Participants|||Number
1276858|NCT00299104|Secondary|Change From Baseline in the Total Erosion Score at Week 24|Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The Total Erosion Score at Week 24 - Total Erosion Score at baseline is calculated.|Baseline, Week 24|Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) who had data available at Week 24 for analysis.|||Score on a scale||Standard Deviation|Mean
1276848|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52|"To achieve an ACR20 response requires at least a 20% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 20% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).|||Percentage of Participants|||Number
1276849|NCT00299104|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52|"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.~Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2"|Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses.|||Percentage of Participants|||Number
1276850|NCT00299104|Secondary|The Percentage of Participants With Major Clinical Response at Week 52|"Major clinical response is defined as a continuous six-month period of success by the ACR70.~ACR70= 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in 3 of five additional measurements from:~the physician’s global assessment of disease activity~patient’s global assessment of disease activity~patient’s assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion.|||Percentage of Participants|||Number
1276851|NCT00299104|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52|European League Against Rheumatism (EULAR) criteria reflects an improvement in disease activity and an attainment of a lower degree of disease activity. A good response is defined as an improvement in the DAS28-ESR of > 1.2 compared with baseline, and attainment of a DAS28-ESR of < 3.2.|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing|||Percentage of Participants|||Number
1276852|NCT00299104|Secondary|Percentage of Participants With DAS28-ESR Remission at Week 52|"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.~Remission is defined as achieving a DAS28-ESR score of less than 2.6"|Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion with data available for analyses.|||Percentage of Participants|||Number
1276853|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52|"To achieve an ACR70 response requires at least a 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).|||Percentage of Participants|||Number
1276854|NCT00299104|Secondary|Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52|"DAS28-ESR is calculated from the following formula:~(0.56 * TJC) + (0.28 * SJC) + (0.70 * ln ESR) + (0.014 * GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient’s global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR < 2.6)."|Baseline, Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1276855|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52|"To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from:~the physician’s global assessment of disease activity~patient’s global assessment of disease activity~patient’s assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).|||Percentage of Participants|||Number
1276856|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression at Week 24|Percentage of patients without radiographic progression at Week 24 defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 24|Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing|||Percentage of Participants|||Number
1276859|NCT00299104|Secondary|Change From Baseline in the Modified Total Sharp Score at Week 24|The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Week 24|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time point for analysis.|||Score on a scale||Standard Deviation|Mean
1276860|NCT00299104|Secondary|Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52|Rate of progression in structural joint damage (PJD) by change in modified joint space narrowing (JSN) from screening to Week 52. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.|||Score on a scale||Standard Deviation|Mean
1276861|NCT00299104|Secondary|Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52|No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero.|Baseline, Week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.|||Percentage of Participants|||Number
1276862|NCT00299104|Secondary|Percentage of Patients Without Radiographic Progression at Week 52|Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) <= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing.|||Percentage|||Number
1276863|NCT00299104|Secondary|Change From Baseline in Modified Sharp Erosion Score at Week 52|Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.|||Score on a scale||Standard Deviation|Mean
1276864|NCT00299104|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52|Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.|||Score on a scale||Standard Deviation|Mean
1276865|NCT00299000|Primary|Change in Haed Circumference||52 weeks||||centimeter||Standard Deviation|Mean
1276866|NCT00299000|Primary|Change in Weight||52 weeks||||kilograms||Standard Deviation|Mean
1276867|NCT00299000|Primary|Change in Height||52 weeks|Intention to treat.|||centimeters||Standard Deviation|Mean
1276868|NCT00299000|Secondary|Change in Urinary Glycosaminoglycan Levels|Change in urinary GAG levels was calculated from baseline to week 52 of treatment.|minimum 52 weeks of dosing|Intention to treat.|||ug/mg creatinine||Standard Deviation|Mean
1276869|NCT00298896|Secondary|Best Overall Response|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started), classified as CR, PR, SD or PD per RECIST criteria.|upto 6 months|Efficacy Analysis Set|||Participants|||Count of Participants
1276870|NCT00298896|Primary|Objective Response Rate|Objective tumor response rate based on the RECIST criteria for target lesions as assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), at least a 20% increase in the sum of the LD of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response (OR) = CR + PR|up to 6 months|Efficacy Analysis Population|||Participants|||Count of Participants
1276871|NCT00298766|Primary|Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination|Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination|from first study-related procedure to 30 days after last dose of study medication|Safety population|||participants|||Number
1276872|NCT00298766|Primary|Subjects Grade 3/4/5 Treatment Emergent Adverse Events|"Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame.~Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0."|from first study-related procedure to 30 days after last dose of study medication|Safety population|||participants|||Number
1276873|NCT00298766|Primary|Subjects With Serious Treatment Emergent Adverse Events|Serious treatment emergent adverse events observed during outcome measure time frame|from first study-related procedure to 30 days after last dose of study medication|Safety population|||participants|||Number
1276889|NCT00298558|Secondary|Estimate the Effects of ACTIVE Training to General Population|To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.|10th Year|||||||
1276874|NCT00298766|Secondary|Best Confirmed Hematologic Responders|Hematologic response was determined by the investigator per the response criteria for immunoglobulin light chain amyloidosis by Gertz (2005). It include Complete and Partial Responders (CR+PR). CR requires serum and urine negative for a monoclonal protein by immunofixation and free light chain ratio normal. PR requires: 1. reduction in quantitative serum M-protein by 50% if baseline value is at least 0.5 g/dL, 2. if light chain is detected in the urine (with a consistent peak and >100 mg/ 24 hours), then 50% reduction is required, 3. if free light chain >10 mg/dL, reduction by 50% is required.|from first dose of study medication to end of study visit|Efficacy population included all treated subjects with an evaluable post baseline resposne assessment in the MTD cohorts (1.6 mg/m^2 QW and 1.3 mg/m^2 BIW).|||participants responded|||Number
1276875|NCT00298766|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame|from first study-related procedure to 30 days after last dose of study medication|Safety population|||participants|||Number
1276876|NCT00298766|Primary|Maximum Tolerated Dose|"Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts.~DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity."|5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts|Phase 1 Safety Population includes all subjects who received at least one dose of VELCADE in phase 1 dose escalation cohorts|||participants with DLT|||Number
1276877|NCT00298740|Primary|Glucose Control as Assessed by Mean Glucose Levels||End of study, approximately 5 years|It is unclear whether data was collected. No data is available and exhaustive searching has yielded no person with historical knowledge of this study or access to any data. Information obtained in other sections was from Regulatory records retrieved from long-term storage. This study closed in 2009 and the Principal Investigator is deceased.||||||
1276878|NCT00298610|Secondary|Safety - Serious Adverse Event (SAE) Relationship to Study Drug|Determine the safety (defined as relationship to study drug of SAE's)|Up to 14 days||||Number of events|||Number
1276879|NCT00298610|Secondary|Safety - Severity of Serious Adverse Events (SAE's)|Determine the safety (defined as severity of SAE's using the Common Toxicity Criteria)|up to 14 days||||Number of events|||Number
1276880|NCT00298610|Secondary|Safety - Adverse Events Relationship to Study Drug|Determine the safety (defined as relationship to study drug of AE's and SAE's)|up to 14 days||||Number of adverse events|||Number
1276881|NCT00298610|Secondary|Safety - Severity of Adverse Events|Determine the safety (defined as severity of AE's using the Common Toxicity Criteria)|up to 14 days||||Number of adverse events|||Number
1276882|NCT00298610|Secondary|Number of Subjects With Fever Clearance|Temperature is measured by oral digital thermometers, and fever clearance time is defined as the first time with resolution of fever (<37.5C) sustained for 24 hours|Within 48 hours post dose|Summary of subject with fever clearance, defined as first sustained absence of fever (<37.5C for least 24 hours)|||Participants|||Count of Participants
1276883|NCT00298610|Secondary|Percentage of Parasite Clearance|The target variable is detection (percentage) of asexual stage parasites of Plasmodium falciparum malaria in bloodstream by Giemsa - stained microscopy of thick and thin blood smears|24 and 48 hours post dose|Percentage of parasite clearance within the first 24 and 48 hours post dose of intravenous artesunate|||percentage of parasite clearance||Standard Deviation|Mean
1276884|NCT00298610|Primary|Change in Percentage of Parasites Detected at 48 Hours|Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases|48 hours|Percentage of parasite change at 48 hours post dose|||percentage of parasite change||Standard Deviation|Mean
1276885|NCT00298558|Primary|Changes in Everyday Speed of Processing From Baseline to Year 10|"Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 938 subjects who had the everyday speed of processing outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
1276886|NCT00298558|Primary|Changes in Everyday Problem Solving From Baseline to Year 10|"Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 1104 subjects who had the everyday problem solving outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
1276887|NCT00298558|Primary|Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10|"The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 1211 subjects who had the IADL outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
1276888|NCT00298558|Primary|Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10|"Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 879 subjects who had the speed outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
1276890|NCT00298558|Primary|Changes in Cognitive Abilities of Reasoning From Baseline to Year 10|"Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 938 subjects who had the reasoning outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
1276891|NCT00298558|Secondary|Examine Health, Genetic and Cognitive Moderators|To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.|10th Year|||||||
1276892|NCT00298558|Secondary|Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use|To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.|10th Year|||||||
1276893|NCT00298558|Primary|Changes in Cognitive Abilities of Memory From Baseline to Year 10|"Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 943 subjects who had the memory outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
1276894|NCT00298363|Secondary|In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results||Baseline to Week 168|Liver transplantation analysis set|||Days|||Number
1276895|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 168|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276896|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 144|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276897|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 96|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276898|NCT00298363|Primary|Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL|Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation.|Baseline to Week 168|Full analysis set|||percent probability (KM estimate)||95% Confidence Interval|Number
1276899|NCT00298363|Other Pre-specified|Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.|Baseline to Week 168|Participants in the full analysis set with both ADV and LAM resistance mutations at baseline were included in this analysis.|||percentage of participants|||Number
1276900|NCT00298363|Other Pre-specified|Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.|Baseline to Week 168|Patients in the full analysis set with LAM resistance mutation at baseline were included in this analysis.|||percentage of participants|||Number
1276901|NCT00298363|Other Pre-specified|Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation.|Baseline to Week 168|Participants in the full analysis set with ADV resistance mutation at baseline were included in this analysis.|||percentage of participants|||Number
1276902|NCT00298363|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 48|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276903|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 168|Serologically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276904|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 144|Serologically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276905|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 96|Serologically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276906|NCT00298363|Secondary|Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 48|Serologically evaluable analysis set (subjects in full analysis set with positive hepatitis B early antigen [HBeAg] at baseline); noncompleters/switch = failure|||percentage of participants|||Number
1276907|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 168|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 168|Subjects in the full analysis set with an available score at the visit|||units on a scale||Inter-Quartile Range|Median
1276908|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 144|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 144|Subjects in the full analysis set with an available score at the visit|||units on a scale||Inter-Quartile Range|Median
1276909|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 96|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 96|Subjects in the full analysis set with an available score at the visit|||units on a scale||Inter-Quartile Range|Median
1276910|NCT00298363|Secondary|Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 48|Subjects in the full analysis set with an available score at the visit|||units on a scale||Inter-Quartile Range|Median
1276911|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 168|CPT evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276912|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 144|CPT evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276913|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 96|CPT evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276914|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 48|CPT evaluable analysis set (subjects with CPT scores ≥ 7 at baseline; because the minimum CPT score was 5, only these subjects were evaluable for analyses of ≥ 2-point decrease in CPT score); noncompleters/switch = failure|||percentage of participants|||Number
1276915|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 168|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276916|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 144|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276917|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 96|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276918|NCT00298363|Secondary|Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 48|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276919|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 168|Biochemically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276920|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 144|Biochemically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276922|NCT00298363|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48|Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 48|Biochemically evaluable analysis set (subjects in full analysis set with abnormal baseline alanine aminotransferase [ALT] values); noncompleters/switch = failure|||percentage of participants|||Number
1276923|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized.|Week 168|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276924|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized.|Week 144|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276925|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized.|Week 96|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
1276926|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized.|Week 48|Full analysis set; noncompleters/switch = failure analysis (participants who did not complete treatment or changed from double-blind to open-label treatment up to the time point were considered as failing to meet efficacy response criteria [defined as not achieving viral suppression of < 400 copies/mL]).|||percentage of participants|||Number
1276927|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 168 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 168 were excluded.|||log_10 copies/mL||Inter-Quartile Range|Median
1276928|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 144 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 144 were excluded.|||log _10 copies/mL||Inter-Quartile Range|Median
1276929|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 96 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 96 were excluded.|||log_10 copies/mL||Inter-Quartile Range|Median
1276930|NCT00298363|Secondary|Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 48 weeks|Participants with HBV DNA measurements at Week 48 were included in this analysis.|||log_10 copies/mL||Inter-Quartile Range|Median
1276931|NCT00298363|Primary|Percent Probability of Tolerability Failure|Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation.|Baseline to Week 168|Full analysis set (all randomized subjects who received at least one dose of study drug)|||percent probability (KM estimate)||95% Confidence Interval|Number
1276932|NCT00298272|Primary|Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings|The following immunological assessments were conducted: autoantibody concentrations for RF, anti-cyclic-citrullinated peptide (CCP) antibody concentrations, quantitative immunoglobulin levels, and lymphocyte assessments of T- and B-cell populations, determined using whole blood expanded fluorescent-activated cell sorter (FACS) analysis. The following laboratory assessments were performed: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC) with differential, and platelet counts; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total protein, albumin, total bilirubin, blood urea nitrogen (BUN), uric acid, creatinine, random glucose, potassium, sodium, chloride, calcium, and phosphorous; blood, protein, and glucose (microscopic examination, if abnormal and applicable).|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||participants|||Number
1276933|NCT00298272|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24|An AE was any sign (including an abnormal laboratory result that the investigator determined to be clinically significant), symptom, or diagnosis/disease that is unfavorable or unintended, that was new, or if pre-existing, worsened in a participant and that did not necessarily have a causal relationship with the treatment. An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||participants|||Number
1276959|NCT00297778|Secondary|Clinical Global Impressions of Global Improvement (CGI-I) at Week 12|The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse)|Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient CGI-I data.|||units on a scale||Full Range|Median
1276934|NCT00298272|Primary|Maximum Duration of Infections Through Week 24|Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of “infections and infestations” and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). For participants with multiple infections, only the infection with the longest duration was included in this analysis.|Week 24|Participants in the Safety Population with at least 1 infection. The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||days||Standard Deviation|Mean
1276935|NCT00298272|Primary|Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24|Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of “infections and infestations” and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). Participants with multiple infections were calculated only once. The severity of all reported adverse events, including infections, was graded and reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events. This scale defines the severity of an adverse event as follows: Grade 1 = a mild adverse event, Grade 2 = a moderate adverse event, Grade 3 = a severe adverse event, and Grade 4 = a life-threatening or disabling adverse event.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||participants|||Number
1276936|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 70 (ACR70) Response at Week 24|An ACR70 response is defined as a 70% reduction in the number of both swollen and tender joints, and a 70% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.|||proportion of participants|||Number
1276937|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 50 (ACR50) Response at Week 24|An ACR50 response is defined as a 50% reduction in the number of both swollen and tender joints, and a 50% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.|||proportion of participants|||Number
1276938|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 24|An ACR20 response is defined as a 20% reduction in the number of both swollen and tender joints, and a 20% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.|||proportion of participants|||Number
1276939|NCT00298272|Primary|Proportion of Participants With at Least One Serious Infection Through Week 24|An infection was considered serious if it required intravenous (IV) antibiotics or met the regulatory definition of a serious adverse event (SAE). An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||proportion of participants|||Number
1276940|NCT00298233|Secondary|Median Time (Days) on Ventilation|Use of mechanical ventilation at any time for subjects with severe influenza and avian influenza.|Throughout study, 14 days||||days||95% Confidence Interval|Median
1276941|NCT00298233|Secondary|Median Time (Days) in ICU||Throughout study, 14 days||||days||95% Confidence Interval|Median
1276942|NCT00298233|Secondary|Median Time (Days) Receipt of Oxygen||Throughout study, 14 days||||days||95% Confidence Interval|Median
1276943|NCT00298233|Secondary|In-hospital Mortality Rates|Standard therapy with oseltamivir is five days. Those patients with persistent symptoms on day five were continued on the randomized dose for an additional five days and assessments were performed up to day 10.|After up to 10 days of treatment||||participants|||Number
1276960|NCT00297778|Secondary|Change From Baseline in the UPDRS Part II+III Total Score at Week 12|The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)|Baseline and Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Standard Error|Least Squares Mean
1276961|NCT00297778|Secondary|Change From Baseline in the UPDRS Part III Total Score at Week 12|The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)|Baseline and Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Standard Error|Least Squares Mean
1276944|NCT00298233|Secondary|Participants Meeting Criteria for Day 5 Clinical Failure|"Proportion of participants that have clinical failure by day 5. Subjects that meet one of the following on Day 5 will be classified as a clinical failure:~Severe tachypnea (respiratory rate ≥ 30 for ages ≥12 years, rate ≥ 40 for ages 6 to 12 years, rate ≥45 for ages 3 to 6 years, rate ≥ 50 for ages 1 to 3 years)~Severe dyspnea (unable to speak full sentences, or use of accessory respiratory muscles)~Arterial oxygen saturation ≤92% on room air by trans-cutaneous method~Need for mechanical ventilation or intensive care unit (ICU) admission For the purpose of endpoint definition, death prior to or on Day 5 will also be considered a clinical failure at Day 5."|After 5 days of treatment|For the purpose of endpoint definition, death prior to or on Day 5 was also considered as clinical failure on day 5.In the double dose cohort, only 154 subjects completed fives days of drug and 7 died (total 161). In the standard dose cohort only 149 subjects completed 5 days of drug and 9 died (total 158).|||participants|||Number
1276945|NCT00298233|Primary|Proportion of All Participants Negative for Viral RNA on Day 5|Proportion of all participants with no detectable viral RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) in a combined nasal and throat swab sample on day 5.|After 5 days of treatment|All randomized patients with RT-PCR proven influenza.|||participants|||Number
1276946|NCT00298155|Secondary|To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT|Serum DHT|After 12 weeks of neoadjuvant androgen deprivation|Patients with clinically localized prostate cancer treated for 3 months with the treatments in Groups 1-3|||ng/dL||Standard Deviation|Mean
1276947|NCT00298155|Primary|Prostate Tissue DHT|Tissue dihydrotesterone (DHT)|After 12 weeks of neoadjuvant androgen deprivation||||ng/g||Standard Deviation|Mean
1276948|NCT00298090|Primary|Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line|Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.|up to 15 minutes|Data from 18 subjects not used due to only partial data captured resulting from logistical issues.|||StO2 percent saturation||95% Confidence Interval|Mean
1276949|NCT00297830|Secondary|Serum N-telopeplide Percent Change||24 months|Serum n-telopeplide percent change was not collected.||||||
1276950|NCT00297830|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months||||percent change||95% Confidence Interval|Mean
1276951|NCT00297830|Secondary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months||||percent change||95% Confidence Interval|Mean
1276952|NCT00297830|Primary|Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months||||percent change||95% Confidence Interval|Mean
1276953|NCT00297778|Secondary|Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs||Baseline and Week 12||||participants|||Number
1276954|NCT00297778|Secondary|Change From Baseline in the UPDRS Part IV Total Score at Week 12|The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.|Baseline and Week 12|FAS. 28 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Standard Error|Least Squares Mean
1276955|NCT00297778|Secondary|Change From Baseline in the UPDRS Part I Total Score at Week 12|The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Inter-Quartile Range|Median
1276956|NCT00297778|Secondary|Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12|The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 – 10 cm) line representing the patient’s degree of general pain. The two extremities of the line were taken to represent ‘no pain’ and ‘unbearable pain’, respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).|Baseline and Week 12|FAS. 15 participants from those randomised and treated were excluded due to insufficient EQ-5D data.|||mm||Standard Error|Least Squares Mean
1276957|NCT00297778|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12|This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Week 12|FAS. 16 participants from those randomised and treated were excluded due to insufficient EQ-5D data.|||units on a scale||Inter-Quartile Range|Median
1276958|NCT00297778|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Week 12|FAS. 52 participants from those randomised and treated were excluded due to insufficient PDQ-39 data.|||units on a scale||Inter-Quartile Range|Median
1277207|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1276962|NCT00297778|Secondary|Change From Baseline in the UPDRS Part II Total Score at Week 12|Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Standard Error|Least Squares Mean
1276963|NCT00297778|Secondary|Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12|The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Inter-Quartile Range|Median
1276964|NCT00297778|Secondary|Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12|The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient SHAPS data.|||units on a scale||Inter-Quartile Range|Median
1276965|NCT00297778|Secondary|Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12|The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient GDS data.|||units on a scale||Standard Error|Least Squares Mean
1276966|NCT00297778|Secondary|Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12|BDI clinical response was defined as a reduction of ≥50% from baseline|Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient BDI data (1 due to a zero baseline score).|||participants|||Number
1276967|NCT00297778|Primary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Week 12|The Full analysis set (FAS) made up of all randomised and treated participants with a baseline and at least one on-treatment assessment of the BDI. 9 participants from those randomised and treated were excluded due to insufficient BDI data.|||Score on scale||Standard Error|Least Squares Mean
1276968|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 39 had CDAI scores at Week 54 and Baseline and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
1276969|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 73 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
1276970|NCT00297648|Secondary|Change From Baseline in Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
1276971|NCT00297648|Secondary|Change From Baseline in Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 52 had a CDEIS score at Week 54 and at Baseline and are included here. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
1276972|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease|Week 10|Of the 89 patients in the Intent to Treat Population, 72 patients had plasma data and histological Crohn's disease score assessment at Week 10, and are included in this summary.|||Pearson Correlation Coefficient||95% Confidence Interval|Number
1276973|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation with a blinded assessment at Week 10. 48 patients had both CDEIS and CRP data at Week 10.|||Pearson Correlation Coefficient||95% Confidence Interval|Number
1277021|NCT00297427|Primary|Mental Health Related Quality of Life|Percent change in mental health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score.|4 weeks post true or sham acupuncture|Intention-to-treat|||percentage change relative to baseline||Inter-Quartile Range|Median
1276974|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data and a CDEIS score at Week 10 and are included in this summary.|||Pearson Correlation Coefficient||95% Confidence Interval|Number
1276975|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10|Of the 89 patients in the Intent to Treat Population, 73 patients had plasma level data and a CDAI score at Week 10 and are included in this summary.|||Pearson Correlation Coefficient||95% Confidence Interval|Number
1276976|NCT00297648|Secondary|Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52|The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.|Baseline, Week 52|Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints.|||ratio||Full Range|Geometric Mean
1276977|NCT00297648|Secondary|Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52||Week 52|Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary.|||mg/L||Full Range|Geometric Mean
1276978|NCT00297648|Secondary|Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10|Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.|||ratio||Full Range|Geometric Mean
1276979|NCT00297648|Secondary|Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10||Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary.|||mg/L||Full Range|Geometric Mean
1276980|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 54|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276981|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276982|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 54|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276983|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 10|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276984|NCT00297648|Secondary|Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
1286686|NCT00168831|Secondary|Change From Baseline in Basophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1276985|NCT00297648|Secondary|Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
1276986|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276987|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276988|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276989|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276990|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276991|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276992|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276993|NCT00297648|Primary|Mean Change From Baseline in CDEIS (Crohn’s Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||Score on a scale||95% Confidence Interval|Mean
1277022|NCT00297427|Primary|Mental Health Related Quality of Life|Percent change in mental health related quality of life measured at 1 week1 post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score. Higher Mental Health Component scores are considered a better outcome.|1 week post-intervention|Intention to treat analysis|||percentage change relative to baseline||Inter-Quartile Range|Median
1276994|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276995|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100|||percentage of patients||95% Confidence Interval|Number
1276996|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276997|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276998|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1276999|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 54|Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1277000|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1277001|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score|Week 10|Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1277002|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
1277003|NCT00297648|Primary|Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||95% Confidence Interval|Mean
1277004|NCT00297596|Secondary|Time to Progression||18 months|||||||
1277005|NCT00297596|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|18 months||||percentage of participants||95% Confidence Interval|Number
1277006|NCT00297492|Primary|Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement|Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million|6 months|This was an intent-to-treat analysis. Those who were lost to follow-up were assumed to not be abstinent from smoking at the time of the 6 month follow-up.|||participants|||Number
1277007|NCT00297427|Secondary|Pelvic Floor Muscle Strength|Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.|Baseline and 4 weeks post true or sham acupuncture||||seconds||Standard Deviation|Mean
1277008|NCT00297427|Secondary|Pelvic Floor Muscle Strength|Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.|Baseline and 1 week post true or sham acupuncture||||seconds||Standard Deviation|Mean
1277009|NCT00297427|Secondary|Response to Booster Acupuncture if Needed|Change in the number of incontinent episodes per day following booster acupuncture|After the booster sessions|Participants who received booster acupuncture treatments during follow-up|||incontinent episodes/day||Standard Deviation|Mean
1277010|NCT00297427|Secondary|Need for Booster Acupuncture During Follow-up|The number of participants who were received true acupuncture (as their initial intervention or after initially receiving sham acupuncture) and were eligible to receive a booster (had a 50% or greater reduction in incontinent episodes following true acupuncture) and completed at least one month of follow-up and experienced a 30% or greater increase in incontinent episodes during follow up.|Monthly during the 6 month follow-up period|Participants who completed true acupuncture (as either their initial treatment or following sham acupuncture), had a 50% or greater reduction in incontinent episodes at 1 or 4 weeks post-true acupuncture, and completed at least one month of follow-up.|||participants|||Number
1277011|NCT00297427|Secondary|Burden Associated With the Acupuncture Treatment Protocol|Subjects' report of burden (difficulty) associated with the frequency, number and duration of treatment) and the position they had to remain in during the true and sham treatments. Subjects rate the difficulty associated with each of the four aspects of treatment on a 10-point scale ranging from 1 (not at all difficult) to 10 (extremely difficult). The burden score was calculated as the average of the scores on the 4 items with a possible range of 1 to 10 with higher scores indicating greater burden.|1 week post-treatment|The number of participants analyzed for this outcome was only those who completed the treatment protocol and the 1-week post-treatment visit. For this reason, the number is smaller than the number for the primary outcomes|||units on a scale||Inter-Quartile Range|Median
1277012|NCT00297427|Secondary|Adherence to Treatment Protocol|Percentage of acupuncture (true or sham) visits completed as scheduled|6 weeks|True and sham acupuncture subjects who completed the 6 weeks of treatment; participants who dropped out of the study during treatment were not included in this analysis|||percent of visits||Standard Deviation|Mean
1277013|NCT00297427|Secondary|Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years|Duration of urinary incontinence in years|Baseline|Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)|||years||Standard Deviation|Mean
1277014|NCT00297427|Secondary|Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)|Glasses/cups per day of non-caffeinated fluids (including water) at baseline|Baseline|Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)|||Glasses/cups per day||Standard Deviation|Mean
1277015|NCT00297427|Secondary|Urodynamic Impression of Urge Urinary Incontinence|Documentation of a diagnostic impression of urge urinary incontinence following urodynamics|Baseline and 4 weeks post true or sham acupuncture||||participants|||Number
1277016|NCT00297427|Secondary|Urodynamic Diagnostic Impression of Stress Urinary Incontinence|Documentation of a diagnostic impression of stress urinary incontinence following urodynamics|Baseline and 4 weeks post-treatment||||participants|||Number
1277017|NCT00297427|Secondary|Change in Bladder Capacity|Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.|Change from baseline to 4 weeks post-intervention|Subjects who agreed to have a cystometrogram at baseline and 4 weeks after completing acupuncture or sham acupuncture.|||milliliters||Standard Deviation|Mean
1277018|NCT00297427|Primary|Duration of Any Beneficial Effects|Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)|monthly during follow-up up to 6 months|Subjects who received true acupuncture and completed at least a 1-month follow-visit post acupuncture|||Months||Standard Error|Mean
1277019|NCT00297427|Primary|Incontinence-Specific Quality of Life|Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire. Positive changes indicate improvement in incontinence-specific quality of life.|4-weeks post-intervention|Intention-to-treat|||percentage change relative to baseline||Inter-Quartile Range|Mean
1277020|NCT00297427|Primary|Incontinence-Specific Quality of Life|Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire. Positive values indicate improvement in incontinence-specific quality of life.|1 Week post-intervention|Intention-to-treat analysis|||percentage change relative to baseline||Inter-Quartile Range|Median
1277046|NCT00297115|Secondary|Time to Mortality Due to Any Reason||52 weeks treatment period|ITT analysis. Number of participants analyzed = number of participants who died.|||days||Standard Deviation|Mean
1277023|NCT00297427|Primary|Physical Health-Related Quality of Life|Percent change in physical health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Positive change indicates an increase in physical health-related quality of life.|4-weeks post-intervention|Intention-to-treat|||percentage change relative to baseline||Inter-Quartile Range|Median
1277024|NCT00297427|Primary|Physical Health-Related Quality of Live|Percent change in physical health related quality of life measured at 1 week post-intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Higher SF-36 Physical Component scores are considered a better outcome.|1 Week post-intervention|Intention-to-treat|||percentage change relative to baseline||Inter-Quartile Range|Median
1277025|NCT00297427|Primary|Percent Change in Incontinent Episodes|Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture|4 weeks post true or sham acupuncture|Intention-to-treat analysis|||percent change in incontinent episodes||Standard Deviation|Mean
1277026|NCT00297427|Primary|Percent Change in Incontinent Episodes|Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.|Baseline to 1 Week post-intervention|Intention-to-treat|||percent change in incontinent episodes||Standard Deviation|Mean
1277027|NCT00297258|Secondary|Overall Response|Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a >=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.|Baseline until either response or progression (up to approximately 5 years)|Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.|||participants|||Number
1277028|NCT00297258|Secondary|Progression Free Survival|Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.|Start of therapy until progression (up to approximately 5 years)|Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.|||years||90% Confidence Interval|Median
1277029|NCT00297258|Secondary|Overall Survival|Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.|Start of therapy until death (up to approximately 5 years)|ITT Population. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.|||years||90% Confidence Interval|Median
1277030|NCT00297258|Primary|Progression Free Survival at Week 12|Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a >=20% increase in target lesions.|Week 12|Intent-to-Treat (ITT) Population: All eligible participants entered into the study and who had taken >=1 dose of investigational product. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.|||participants|||Number
1277031|NCT00297232|Primary|Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0|Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as ≥ 1.0 point decrease from baseline sustained for 24 weeks.|Up to 480 weeks|Participants with EDSS improvement (regardless of length of follow-up) sustained for 24 weeks.|||weeks||Inter-Quartile Range|Median
1277032|NCT00297232|Primary|Time to 48-week Confirmed EDSS Progression|Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.|up to 480 weeks|Participants with EDSS progression (regardless of length of follow-up) sustained for 48 weeks.|||weeks||Inter-Quartile Range|Median
1277033|NCT00297232|Primary|Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression|Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.|up to 480 weeks|Participants with EDSS progression (regardless of length of follow-up) sustained for 24 weeks.|||weeks||Inter-Quartile Range|Median
1277034|NCT00297167|Other Pre-specified|Percentage of Stools With Blood|Mean percentage of stools with blood during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with blood divided by the total number of stool per day.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||percentage of stools with blood per day||Standard Deviation|Mean
1277035|NCT00297167|Other Pre-specified|Percentage of Visible Oil or Grease in Stool|Mean percentage of stools with visible oil or grease during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with visible oil or grease divided by the total number of stool per day.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||percentage of visible oil or grease/day||Standard Deviation|Mean
1277036|NCT00297167|Secondary|Mean Number of Abdominal Symptoms|Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||symptoms per day||Standard Deviation|Mean
1277037|NCT00297167|Secondary|Percentage of Stool Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||percentage of stools||Standard Deviation|Mean
1277038|NCT00297167|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||stools per day||Standard Deviation|Mean
1277039|NCT00297167|Secondary|Vitamin E Levels|Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."|||mg/L||Standard Deviation|Mean
1277040|NCT00297167|Secondary|Vitamin A Levels|Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."|||microgram per liter (mcg/L)||Standard Deviation|Mean
1277041|NCT00297167|Secondary|Lipid Levels|Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specific time point in each treatment arm."|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1277042|NCT00297167|Secondary|Percent Coefficient of Nitrogen Absorption (CNA%)|Percent CNA was calculated as ([nitrogen intake-nitrogen excretion]/nitrogen intake)*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|"Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."|||percent CNA||Standard Error|Least Squares Mean
1277043|NCT00297167|Primary|Percent Coefficient of Fat Absorption (CFA%)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|"Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."|||percent CFA||Standard Error|Least Squares Mean
1277044|NCT00297115|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
1277045|NCT00297115|Secondary|Natural Log-transformed C-reactive Protein (CRP)|Mean change from baseline to the last post randomization measurement in natural log-transformed CRP|Change from baseline to last post randomization measurement (52 weeks)|ITT analysis. Number of participants analyzed = number of participants with data available.|||mg/L||95% Confidence Interval|Least Squares Mean
1277048|NCT00297115|Primary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|52 weeks treatment period|ITT analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
1277049|NCT00297115|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
1277050|NCT00297102|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
1277051|NCT00297102|Secondary|Natural Log-transformed C-reactive Protein (CRP)|Mean change from baseline to the last post randomization measurement in natural log-transformed CRP|Change from baseline to last post randomization measurement (52 weeks)|ITT analysis. Number of participants analyzed = number of participants with data available.|||mg/L||95% Confidence Interval|Least Squares Mean
1277052|NCT00297102|Secondary|Time to Mortality Due to Any Reason||52 weeks treatment period|ITT analysis. Number of participants analyzed = number of participants who died.|||days||Standard Deviation|Mean
1277053|NCT00297102|Secondary|Post-bronchodilator FEV1 [L]|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
1277054|NCT00297102|Primary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|52 weeks treatment period|ITT analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
1277055|NCT00297102|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
1277056|NCT00297037|Secondary|The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters.|Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.|0, 1, 2, 4, 6 weeks||||mm||Full Range|Mean
1277057|NCT00297037|Secondary|The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10).|The secondary efficacy variables were change in the size of the target erosion, erythema and assessment of spontaneous pain on a visual analog scale (0-10). The scale used to measure erythema is 0-3. 0 is no erythema, 1 is mild erythema, 2 is moderate erythema, and 3 is severe erythema. Minimum score is 0. Maximum score is 3. Spontaneous pain was scored on a scale of 0-10 (0 no pain, 10 severe pain). Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).|0, 1, 2, 4, 6 weeks||||units on a scale||Full Range|Mean
1277058|NCT00297037|Primary|The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6.|The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).|0, 1, 2, 4, 6 weeks|ITT using last observation carried forward for missing data|||units on a scale||Full Range|Mean
1277059|NCT00296816|Secondary|Median Overall Survival Time|"Survival was the observed length of life from entry into the study to death or the date of last contact.~The median overall survival time was estimated using Kaplan-Meier Curve."|up to approximately 1700 days after treatment initiation|Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||days||90% Confidence Interval|Median
1277060|NCT00296816|Secondary|Overall Survival Rate|"Survival was the observed length of life from entry into the study to death or the date of last contact.~The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here."|up to up to approximately 1700 days after treatment initiation|Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||percentage of participants||95% Confidence Interval|Number
1277061|NCT00296816|Secondary|CA-125 Response Rate|"A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days.~The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup."|up to 12 months after treatment initiation|All participants with non-measurable and measurable disease at baseline, and a pretreatment sample that was at least twice the ULN value for CA-125 within 2 weeks of first study treatment.|||percentage of participants||95% Confidence Interval|Number
1277062|NCT00296816|Secondary|Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline|"The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first.~Participants were~censored on the last available CA 125 biomarker blood draw date if~left the study prior to disease progression or death~they received off-study anti-tumor medication~underwent debulking surgery~censored at Day 1 if they were alive had no post baseline CA 125 biomarker blood draw."|up to approximately 1500 days following treatment initiation|All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.|||days||95% Confidence Interval|Median
1277063|NCT00296816|Secondary|Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline|"Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died.~Disease progression included the following:~the appearance of a new lesion~symptomatic deterioration~progression of non-target lesions~a predefined serum CA 125 increase.~RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS."|up to 12 months following treatment initiation|All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.|||percentage of participants||95% Confidence Interval|Number
1277064|NCT00296816|Secondary|Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)|"Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which:~Complete response (CR) was the disappearance of all target and non-target lesions, with no evidence of new lesions~Partial response (PR) was at least a 30% decrease in the sum of longest dimensions (LD) of all measurable target lesions~Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks."|up to 12 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||participants|||Number
1277065|NCT00296816|Secondary|Median Time to Progression-free Survival (PFS)|"Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first.~Time of PFS was censored~on the last available tumor assessment date for participants leaving the study prior to disease progression or death; and also for participants requiring off-study medication or additional debulking surgery (where assessment date used was the one prior to off-study medication or surgery),~at Day 1, for living participants with no post-baseline tumor assessments.~Median PFS was estimated from a Kaplan-Meier curve."|up to approximately 1300 days following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||days||95% Confidence Interval|Median
1277066|NCT00296816|Secondary|Twenty Four-month Progression-free Survival (PFS) Rate in Participants|"Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST).~Disease progression was recorded as any one of the following:~appearance of a new lesion~symptomatic deterioration~progression of target or nontarget lesions~death~Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS."|up to 24 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||percentage of participants||95% Confidence Interval|Number
1277067|NCT00296816|Primary|Twelve-month Progression-free Survival (PFS) Rate in Participants|"Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST).~Disease progression was recorded as any one of the following:~appearance of a new lesion~symptomatic deterioration~progression of target or nontarget lesions~death~Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS."|up to 12 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||percentage of participants||95% Confidence Interval|Number
1277068|NCT00296647|Primary|6 Month Self-reported Abstinence From Smoking|Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)|6 months|intent to treat|||participants|||Number
1277069|NCT00296517|Secondary|Safety: Adverse Events by Organ System Class, Intensity, and Frequency|Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.|Baseline to Week 12|Safety population: comprised of participants who took at least one dose of the treatment period investigational product. The number of participants analyzed for this outcome measure represents the total number of events at each intensity.|||Number of events|||Number
1277070|NCT00296517|Secondary|Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12|Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).|Week 12|Full analysis set. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).|||participants|||Number
1277082|NCT00296504|Secondary|Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions|The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving FPV or NFV in Studies APV30001 and APV30002.|||participants|||Number
1277071|NCT00296517|Secondary|Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.|Baseline to Week 8 and Week 12|Full Analysis set. Week 8 Last Observation Carried Forward: placebo = 153, Bupropion = 159; Week 8 Observed Cases: placebo = 113, Bupropion = 106; Week 12 Last Observation Carried Forward: placebo = 156, Bupropion = 158; Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Percentage of Responders||95% Confidence Interval|Mean
1277072|NCT00296517|Secondary|Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12|The 7-point Clinical Global Impressions–Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.|Baseline to Weeks 1, 2, 3, 4, 8, and 12|Full Analysis Set|||Points on scale||Standard Deviation|Mean
1277073|NCT00296517|Secondary|Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Last Observation Carried Forward, LOCF; Gastrointestinal, GI; Somatic, Som.; General, Gen.; Week, W.|||percent change in score||Standard Deviation|Mean
1277074|NCT00296517|Secondary|Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward (LOCF): placebo=152, Bupropion=160; Week 12 LOCF: placebo=155, Bupropion=160. Gastrointestinal, GI.|||points on a scale||Standard Deviation|Mean
1277075|NCT00296517|Secondary|Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7.|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Percentage of Remitters||95% Confidence Interval|Mean
1277076|NCT00296517|Secondary|Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score.|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160, Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Percentage of Responders||95% Confidence Interval|Mean
1277077|NCT00296517|Secondary|Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Percent Change in score||Standard Deviation|Mean
1277078|NCT00296517|Secondary|Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Score in a scale||Standard Deviation|Mean
1277079|NCT00296517|Secondary|Hamilton Depression Scale (HAM-D 17 Items) Total Score|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Score in scale||Standard Deviation|Mean
1277080|NCT00296517|Primary|Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline and Week 12|Full Analysis Set was all subjects who entered the treatment phase with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment. Week 12/LOCF placebo = 155, Bupropion SR = 160|||Score in scale||Standard Deviation|Mean
1277081|NCT00296504|Secondary|Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions|The number of participants with the indicated HIV-associated conditions were assessed.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.|||participants|||Number
1277083|NCT00296504|Secondary|Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline|The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.|||participants|||Number
1277084|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Weeks 180, 240, 300, 360, 420, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.|||log 10 copies per milliliters||Full Range|Median
1277085|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.|||log 10 copies per milliliter||Full Range|Median
1277086|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.|||log 10 copies per milliliter||Full Range|Median
1277087|NCT00296504|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis|Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 24, 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naїve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.|||cells per millimeters cubed (cells/mm^3)||Full Range|Median
1277088|NCT00296504|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis|Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 48, 120, 168, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.|||cells per millimeters cubed (cells/mm^3)||Full Range|Median
1277089|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.|Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.|||percentage of participants|||Number
1277090|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.|Baseline and Weeks 12, 24, 48, 60, 96, and 132|All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.|||percentage of participants|||Number
1277091|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.|Baseline and Weeks 48, 120, 180, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.|||percentage of participants|||Number
1277092|NCT00296504|Primary|Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.|||units per liter (U/L)||Inter-Quartile Range|Median
1277093|NCT00296504|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.|||units per liter (U/L)||Inter-Quartile Range|Median
1277094|NCT00296504|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.|||units per liter (U/L)||Inter-Quartile Range|Median
1277095|NCT00296504|Primary|Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432|Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.|||ratio||Inter-Quartile Range|Median
1277096|NCT00296504|Primary|Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168|Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.|||ratio||Inter-Quartile Range|Median
1277097|NCT00296504|Primary|Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216|blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.|||ratio||Inter-Quartile Range|Median
1277098|NCT00296504|Primary|Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432|Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.|||milligrams per deciliter (mg/dl)||Inter-Quartile Range|Median
1277099|NCT00296504|Primary|Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216|Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.|||milligrams per deciliter (mg/dl)||Inter-Quartile Range|Median
1277100|NCT00296504|Primary|Number of Participants With Any Adverse Event (AE): Final Analysis|"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section."|Post January 2006; for up to 241 weeks|All participants who remained in the study after January 31, 2006.|||participants|||Number
1277101|NCT00296504|Primary|Number of Participants With Any Adverse Event (AE): Interim Analysis|"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section."|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.|||participants|||Number
1277102|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population|Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Percentage of rescue-free days||Standard Error|Mean
1277103|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Percentage of rescue-free days||Standard Error|Mean
1277104|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population|Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Percentage of asthma symptom-free days||Standard Error|Mean
1277105|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Percentage of asthma symptom-free days||Standard Error|Mean
1277106|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population|Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||L/sec||Standard Error|Mean
1277107|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population|Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||L/sec||Standard Error|Mean
1277108|NCT00296491|Secondary|Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)|The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.|Baseline To 1-2 Weeks|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Points on a Scale||Standard Error|Mean
1277109|NCT00296491|Secondary|Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).|The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)|Baseline to 1-2 Weeks|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Points on a Scale||Standard Error|Mean
1277110|NCT00296491|Primary|Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population|Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol.|||L/min||Standard Error|Mean
1277111|NCT00296491|Primary|Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment.|||L/min||Standard Error|Mean
1277112|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277113|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277208|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277114|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277115|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277116|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277117|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277118|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277119|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277120|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277121|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277122|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277123|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277124|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277125|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277126|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277127|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277288|NCT00295932|Secondary|Overall Survival||2 years|Data were not collected||||||
1277289|NCT00295932|Secondary|Event-free Survival||2 years|Data were not collected||||||
1277128|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277129|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277130|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277131|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277132|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277133|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277134|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277135|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277136|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks||||Correlation coefficient|||Number
1277137|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277138|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277139|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277140|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277181|NCT00296400|Secondary|Urinary Albumin/Creatinine Ratio at Week 26|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at baseline and Week 26||||ratio||95% Confidence Interval|Geometric Mean
1277141|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277142|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277143|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277144|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277145|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277146|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277147|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277148|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277149|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277150|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277151|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277152|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277153|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277154|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277155|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277156|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277157|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277158|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277159|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277160|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277161|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277162|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277163|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277164|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277165|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277166|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277167|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277168|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277169|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277170|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277171|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26|"Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.~)"|Baseline and 26 weeks||||Correlation coefficient|||Number
1277172|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
1277173|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|26 weeks||||Correlation coefficient|||Number
1277174|NCT00296400|Secondary|Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks||||Correlation coefficient|||Number
1277175|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
1277176|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks||||Correlation coefficient|||Number
1277177|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|baseline and 26 weeks||||Correlation coefficient|||Number
1277178|NCT00296400|Secondary|Change From Baseline in eGFR at Week 52 [LOCF]|The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.|Assessed at baseline and Week 52 [LOCF]||||mL/min||Standard Deviation|Mean
1277179|NCT00296400|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26|The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.|Assessed at baseline and Week 26||||mL/min||Standard Deviation|Mean
1277180|NCT00296400|Secondary|Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at baseline and Week 52 [LOCF]||||ratio||95% Confidence Interval|Geometric Mean
1277290|NCT00295932|Secondary|Duration of Response (Mean and Median)||2 years|Data were not collected||||||
1277182|NCT00296400|Secondary|Urinary Protein/Creatinine Ratio at Week 26.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at baseline and Week 26||||ratio||95% Confidence Interval|Geometric Mean
1277183|NCT00296400|Primary|Urinary Protein/Creatinine Ratio at Week 52 [LOCF]|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at baseline and Week 52 (LOCF)||||ratio||95% Confidence Interval|Geometric Mean
1277184|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
1277185|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277186|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
1277187|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277188|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
1277189|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277190|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
1277191|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277192|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
1277193|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277194|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
1277195|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277196|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
1277197|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277198|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
1277199|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277200|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277201|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277202|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277203|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277204|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277205|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277291|NCT00295932|Secondary|Progression-free Survival||2 years|Data were not collected||||||
1277209|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277210|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277211|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277212|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277213|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277214|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277215|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277216|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277217|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277218|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277219|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277220|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277221|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277222|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277223|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277224|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277225|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277226|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277227|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277228|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277229|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277359|NCT00294762|Secondary|Overall Survival at 12 Months|Percentage of patients alive after 12 months of study treatment|12 months from 1st dose|All patients who received at least 1 dose of study drug|||Percent of Patients||95% Confidence Interval|Number
1277230|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277231|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277232|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277233|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277234|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277235|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277236|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277237|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277238|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277239|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277240|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277241|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277242|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277243|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277244|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277245|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277246|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
1277247|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
1277248|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|Assessed at 52 Weeks||||Correlation coefficient|||Number
1277249|NCT00296374|Secondary|Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).|52 weeks||||Correlation coefficient|||Number
1277250|NCT00296374|Secondary|Change From Baseline in eGFR at Week 52 [LOCF]||Assessed at Baseline and Week 52 [LOCF]||||mL/min||Standard Deviation|Mean
1277251|NCT00296374|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26||Assessed at Baseline and Week 26||||mL/min||Standard Deviation|Mean
1277252|NCT00296374|Secondary|Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at Week 52 LOCF||||mg/g||95% Confidence Interval|Geometric Mean
1277253|NCT00296374|Secondary|Urinary Albumin/Creatinine Ratio at Week 26|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at Week 26||||mg/g||95% Confidence Interval|Geometric Mean
1277254|NCT00296374|Secondary|Urinary Protein/Creatinine Ratio at Week 26.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at Week 26||||mg/g||95% Confidence Interval|Geometric Mean
1277255|NCT00296374|Primary|Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at Week 52, Last observation carried forward (LOCF)||||mg/g||95% Confidence Interval|Geometric Mean
1277256|NCT00296335|Secondary|Number of Patients With Adverse Events|Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years|Up to 3 years||||participants|||Number
1277257|NCT00296335|Secondary|Overall Survival Rate|Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.|3 years||||percentage of participants||95% Confidence Interval|Number
1277258|NCT00296335|Primary|Relapse-free Survival Rate|"Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery.~Relapse was defined as any new tumor lesion."|3 years|Intention-to treat population|||percentage of participants||95% Confidence Interval|Number
1277259|NCT00296322|Secondary|Overall Survival||3 years||||percentage of participants||95% Confidence Interval|Number
1277260|NCT00296322|Secondary|Toxicity Profile (According to NCI CTC Version 2.0)|Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will.|up to 1 year||||participants|||Number
1277261|NCT00296322|Primary|Relapse-free Survival||3 years||||percentage of participants||95% Confidence Interval|Number
1277262|NCT00296296|Secondary|Count of Participants With Biopsy Proven Acute Rejection at One Year Post Transplantation||1 year post-transplantation||||Participants|||Count of Participants
1277263|NCT00296296|Secondary|Patient Survival at One Year Post Transplantation|Count of participants alive at one year post transplantation|Up to 1 year post-transplantation||||Participants|||Count of Participants
1277264|NCT00296296|Primary|Estimated Glomerular Filtration Rate (eGFR) 1 Year Following Transplantation|Values of ≥60 ml/min/1.73 m^2 are considered optimal; ≥30-59 ml/min/1.73 m^2 are indicative of successful graft function; lower values are indicative or graft dysfunction.|1 year post-transplantation||||Participants|||Count of Participants
1277265|NCT00296296|Primary|Freedom From Insulin Therapy Post Transplant|The count of participants with freedom from insulin therapy post transplant is reported.|From hospital discharge to 1 year post-transplant||||Participants|||Count of Participants
1277266|NCT00296244|Secondary|New-onset Diabetes Mellitus (NODM) as Secondary Outcome|The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups.|6 months||||Percentage of participants|||Number
1277267|NCT00296244|Secondary|Incidence and Severity of HCV Recurrence Post-OLT|The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups.|6 months post-transplant|Only patients with HCV cirrhosis as the main indication for OLT were included in this analysis|||Percentage of participants|||Number
1277268|NCT00296244|Secondary|Infection as an Adverse Effect of Steroids|Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection|3 months post-transplant||||Percentage of participants|||Number
1277269|NCT00296244|Primary|Acute Rejection Rate|Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive|6 months post-transplant||||Percentage of participants|||Number
1277270|NCT00296244|Primary|Patient Survival Rate|Percentage of recipients who are still alive at the end of 1 and 2 years.|1 and 2 years||||Percentage of participants|||Number
1277271|NCT00296244|Primary|Graft Survival Rate|Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.|1 and 2 years||||percentage of participants|||Number
1277272|NCT00296231|Secondary|Transcutaneous CO2 Measurements as a Trend Throughout Intervention|We used a transcutaneous CO2 monitor (TCOM) as a safety device throughout the study. We analyzed the change in TCOM readings recorded every 30 minutes (5 measurements) to determine safety|2 hours||||torr||Standard Deviation|Mean
1277273|NCT00296231|Primary|pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values|Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control.|2 hours||||mm Hg||Standard Deviation|Mean
1277274|NCT00296192|Secondary|"Time of First Off Reversal"|"Number of minutes to first reversal of symptoms from off to on. Estimated via Kaplan-Meier estimation method. On and off state refer to periods where Parkinson's disease symptoms are not present (on) and periods where symptoms are present (off); the on/off determination at each assessment timepoint was made by the investigator."|Up to 6 hours post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.|||minutes||95% Confidence Interval|Median
1277360|NCT00294762|Secondary|Progression-free Survival|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|Until time of disease progression, as assessed every 21 days (maximum 28.8 months)|All patients who received at least 1 dose of study drug|||months||Full Range|Median
1277275|NCT00296192|Secondary|"Success Rate (Percentage of Subjects Achieving Off Reversals)"|"Subjects reversing from off to on following initiation of treatment. On and off state refer to periods where Parkinson's disease symptoms are not present (on) and periods where symptoms are present (off); the on/off determination at each assessment timepoint was made by the investigator."|Up to 6 hours post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.|||percentage of participants|||Number
1277276|NCT00296192|Secondary|Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)|One-minute tapping rate will be calculated as the number of times a subject could tap on two 4 x 4 cm marks placed on a board 30 cm apart during 1 minute (30 cm measured from the inner border of the two boxes).|Baseline and 34 minutes post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 34 minutes post-dose timepoint were not imputed; number of observations at 34 minutes post-dose timepoint may be less than that for baseline timepoint.|||taps per minute||Standard Deviation|Mean
1277277|NCT00296192|Secondary|Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination|The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale for the assessment of function in Parkinson’s disease. UPDRS Part III measures Motor Examination. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 24 minute value minus baseline value.|Baseline, and 24 minutes post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 24 minutes post-dose timepoint were not imputed; number of observations at 24 minutes post-dose timepoint may be less than that for baseline timepoint.|||score on a scale||Standard Deviation|Mean
1277278|NCT00296192|Primary|Number of Subjects Who Complete the Trial||15 days|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.|||participants|||Number
1277279|NCT00296140|Secondary|Self-efficacy|Patient-reported self-efficacy for stroke symptom management, range 1.0 - 10.0, higher scores indicate greater self-efficacy for stroke symptom management|6 months|Comparison of self-rated self efficacy for managing stroke symptoms between intervention and control subjects|||units on a scale||Standard Deviation|Mean
1277280|NCT00296140|Secondary|SS-QOL|Stroke-specific quality of life scale, score range 1.0 - 5.0, higher scores indicate better self-reported quality of life.|6 months|Comparison of overall SS-QOL scores between intervention and control subjects|||units on a scale||Standard Deviation|Mean
1277281|NCT00296140|Primary|PHQ-9|Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms|6 months|Comparison of PHQ-9 scores between intervention and control groups|||units on a scale||Standard Deviation|Mean
1277282|NCT00296036|Secondary|Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream in Combination With Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine Caused Palmar-plantar Erythrodysesthesia.|A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated.|First 3 weeks of treatment|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.||||||
1277283|NCT00296036|Secondary|Evaluate the Potential Toxicity of Vitamin B6.|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|up to 4, 21-day cycles|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.||||||
1277284|NCT00296036|Secondary|Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD).|A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated and percentages are reported.|First 3 weeks of treatment|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.||||||
1277285|NCT00296036|Secondary|To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 4, 21-day cycles|All patients that were evaluated for adverse events were included in this analysis.|||participants|||Number
1277286|NCT00296036|Primary|To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia|A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.|First 3 weeks of treatment|Eight patients from the Urea/Lactic Acid group were not included in the primary analysis (1 did not fill out the diary, 1 refused treatment, 3 had adverse events before completing the diary, and 3 for other reasons). For the placebo arm, 11 were excluded (2 refused further treatment, 2 had adverse events, and 7 went off for other reasons).|||percentage of participants|||Number
1277287|NCT00295932|Secondary|Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma|Toxicity assessed using NCI-CTC v. 3.0|2 years||||Participants|||Count of Participants
1277292|NCT00295932|Primary|Maximum Tolerated Dose|Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants|2 years|This outcome is only applicable for Phase I portion of the study. The purpose of the Phase I portion of the study is to determine the Maximum Tolerated Dose and for this reason the results are not separated by dose level.|||mg/m^2 of Bortezomib|||Number
1277293|NCT00295880|Secondary|Number of Patients With Chronic Graft-versus-host Disease (GVHD).|Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.|1 year post transplant|Only 7 patients were at risk for chronic GVHD|||Participants|||Number
1277294|NCT00295880|Secondary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)|Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.|100 days post transplant|2 patients were not yet graded for acute gvhd|||Participants|||Number
1277295|NCT00295880|Secondary|Number of Patients Surviving at Day 100 and 1 Year.|Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.|Day 100 and 1 year||||Participants|||Number
1277296|NCT00295880|Secondary|Number of Patients With Transplant-related Mortality (TRM)|Number of patients who were deceased at days 100 and 180 from any cause other than relapse.|Day 100 and Day 180||||Participants|||Number
1277297|NCT00295880|Secondary|Number of Patients With Acute Graft-versus-host Disease (GVHD)|Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.|100 days post transplant|2 patients were not graded for acute GVHD due to graft failure.|||Participants|||Number
1277298|NCT00295880|Secondary|Number of Patients With Evidence of Engraftment.|Number of patients who received both cord blood units and achieved sustained donor engraftment|1 year|1 patient was not evaluable due to graft failure|||Participants|||Number
1277299|NCT00295880|Secondary|Number of Patients Achieving Neutrophil Recovery|Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.|6 months|Patients who completed treatment.|||Participants|||Number
1277300|NCT00295880|Primary|Median Number of Days to Neutrophil Engraftment|Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.|Daily through Day 60 post transplant||||Days||Full Range|Median
1277301|NCT00295854|Primary|"Number Subjects at Least Moderately Improved for Each Treatment Group in Patient Reported Global Response Assessment (GRA)"|The primary endpoint was the GRA overall change “in their condition” at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved.|8 weeks||||participants|||Number
1277302|NCT00295854|Secondary|Number of Responders for GRA Assessment in Their Condition at Week 4.|Responders were defined as patients who were ‘moderately improved’ or ‘markedly improved’ and non-responders were defined as patients who were ‘markedly worse’, ‘moderately worse’, ‘mildly worse’, no change, or ‘mildly improved’ on the GRA assessments.|4 weeks||||participants|||Number
1277303|NCT00295750|Secondary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|12 months|ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.|||participants|||Number
1277304|NCT00295750|Secondary|The Mean Value of QTc Interval as Measured by Electrocardiogram|The QTc interval results are calculated with Fridericia’s correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.|12 months|ITT population. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.|||milliseconds||Standard Deviation|Mean
1277305|NCT00295750|Secondary|Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)|Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.|Baseline to Day 364|ITT population|||participants|||Number
1277306|NCT00295750|Secondary|Participants Grouped by Time to Prostate-specific Antigen Failure|The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.|12 months|ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.|||participants|||Number
1277307|NCT00295750|Secondary|Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28|Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.|Days 14 and 28|ITT population.|||percent change||Inter-Quartile Range|Median
1277308|NCT00295750|Secondary|Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252|Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252.|Day 252, Day 255, and Day 259|ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.|||participants|||Number
1277309|NCT00295750|Secondary|Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3|This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.|3 days|ITT population.|||percentage of patients||95% Confidence Interval|Mean
1277310|NCT00295750|Secondary|Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment|A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).|2 weeks|ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.|||percentage of patients||95% Confidence Interval|Mean
1277311|NCT00295750|Primary|Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.|12 months|Intent-to-treat (ITT) population.|||percentage of patients||95% Confidence Interval|Mean
1277312|NCT00295633|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
1277313|NCT00295633|Secondary|Percentage of Participants Achieving A1c <7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetic Association’s defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, subjects must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
1277314|NCT00295633|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
1277315|NCT00295633|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.|||percent||Standard Error|Mean
1277316|NCT00295503|Secondary|Overall Survival|overall survival was measured from time of initiation of treatment to death from any cause|from time of enrollment to death from any cause. Patients still alive at study end were censored with a minimum follow up of 6 months.||||months||95% Confidence Interval|Median
1277317|NCT00295503|Secondary|Response Rate|response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months||||percentage of participants|||Number
1277318|NCT00295503|Primary|Progression Free Survival Rate at 6 Months|This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.|patients progression free at 6 months||||percentage of participants|||Number
1277319|NCT00295490|Secondary|Adverse Event Reporting|To identify Group differences between the number of adverse event recorded by patient for both serious and non serious adverse events, as well as events considered being attributable to the study medication.|Baseline and weeks 2,4,6,8,12 and 16|Zero participants were analysed as the study was terminated prematurely|||Participants||95% Confidence Interval|Number
1277320|NCT00295490|Secondary|Complementary and Alternative Medicine Beliefs Inventory|Questionnaire to assess changes in attitudes and health beliefs to CAM.the questionnaire as 17 questions, each scored on a 7 point likert scale from strongly disagree to strongly agree; a higher score indicates stronger belief in the measure. Minimum score 17, maximum score 119|four monthly|Zero participants were analysed as the study was terminated prematurely|||unit on scale||95% Confidence Interval|Mean
1277321|NCT00295490|Secondary|Patient Global Assessment|To assess changes in the subject’s well-being based on 7 point likert scale ranging from very poor (0 point) to very good (7 point). Outcome was recorded at baseline, week 8 and end of treatment at week 16. We reported outcome as the change in patient global assessment from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely|||Unit on scale (Likert from very poor to||95% Confidence Interval|Mean
1277322|NCT00295490|Secondary|Short Form-36 (SF-36)|Quality of Life assessment containing 8 scales clustered into 2 summary scales: physical health and mental health. Each question is scored out from 0 (indicating worst health) to 100 (indicating best health). Mean scores for the 8 scales (total scores/no questions completed) are calculated to give a total score for each of the two summary scales between 0 (worst health) and 100 (best health). SF36 was recorded at baseline, week 8 and at the end of treatment at week 16. we reported the change from baseline to end of treatment as the outcome.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.|||Unit of scale||95% Confidence Interval|Mean
1277323|NCT00295490|Secondary|Stiffness Subscale on the The Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on two questions addressing stiffness in osteoarthritis;a higher score indicating worse symptoms. The VAS used terminators of no stiffness (0mm) to extreme stiffness (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.|||Unit on 100mm VAS scale||95% Confidence Interval|Mean
1286687|NCT00168831|Secondary|Change From Baseline in Eosinophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1277324|NCT00295490|Secondary|Disability Subscale on The Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on twelve questions addressing disability in osteoarthritis with a higher score indicating worse symptoms. The VAS used terminators of no disability (0mm) to extreme disability (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.|baseline, 8 and 16 weeks|Zero participants were analysed as the study was terminated prematurely|||unit on 100mm VAS scale||95% Confidence Interval|Mean
1277325|NCT00295490|Secondary|Pain Subscale on Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on five questions addressing pain in osteoarthritis using the terminators no pain (0mm) to extreme pain (100mm). a higher score therefore indicates more severe pain. This outcome was recorded at baseline, week 8 and week 16 (end of treatment). The outcome for this study was reported as the change in WOMAC pain score from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.|||Unit on 100mm VAS scale||95% Confidence Interval|Mean
1277326|NCT00295490|Primary|Western Ontario and Mc Master University OA Index (WOMAC)|WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.|||Unit on 100mm scale||Standard Deviation|Mean
1277327|NCT00295061|Primary|Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7|"The primary objective of this study was to demonstrate the pharmacokinetic comparability (geometric least square mean ratio of AUC between the Alpha-1 MP vs. Prolastin®, 90% confidence interval falls within 0.80-1.25, FDA Guidance as being bioequivalent between two treatments) of Alpha-1 MP to Prolastin® in subjects with alpha-1-anti-trypsin (AAT) deficiency by comparing AUC from Day 0 to Day 7 of plasma Alpha1-PI measured by the functional activity (potency) assay. AUC from Day 0 to Day 7 was calculated at steady state at the end of the first and second 8-week treatment periods during the 16-week double-blind, crossover phase."|Day 0 to Day 7||||mg*h/mL|||Number
1277328|NCT00295022|Secondary|Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season|At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: “Do you want to take the same treatment during the next pollen season?” (yes or no).|At the end of Period III (Day 2)|Only subjects with valid data were included in the analysis.|||percentage of participants|||Number
1277329|NCT00295022|Secondary|Global Satisfaction of the Subjects at the End of Period III|Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied).|At the end of Period III (Day 2)|Only subjects with valid data for Global Satisfaction (VAS Score) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1277330|NCT00295022|Secondary|Variability of Action From Baseline in the MSC Score Over Period III|"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%."|Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]||||percentage of participants|||Number
1277331|NCT00295022|Secondary|Variability of Action From Baseline in the MSC Score Over Period II|"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%."|Treatment Period II [Day 2, from 9:30 am to 11:00 am]||||percentage of participants|||Number
1277332|NCT00295022|Secondary|Variability of Action From Baseline in the MSC Score Over Period I|"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%."|Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]||||percentage of participants|||Number
1277333|NCT00295022|Secondary|Intensity of Action From Baseline in the MSC Score Over Period III|The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.|Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]||||percentage of participants|||Number
1277334|NCT00295022|Secondary|Intensity of Action From Baseline in the MSC Score Over Period II|The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.|Treatment Period II [Day 2, from 9:30 am to 11:00 am]||||percentage of participants|||Number
1277335|NCT00295022|Secondary|Intensity of Action From Baseline in the MSC Score Over Period I|The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.|Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]||||percentage of participants|||Number
1277336|NCT00295022|Secondary|Onset of Action During Period I|The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time.|During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]||||hours|||Number
1277337|NCT00295022|Secondary|Time to First Feeling of Improvement During Period I|During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms).|During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Subjects with no first feeling of improvement were censored at 300 minutes.|||minutes||95% Confidence Interval|Median
1286688|NCT00168831|Secondary|Change From Baseline in Neutrophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1277338|NCT00295022|Secondary|Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid individual symptom scores during the Total Treatment Period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277339|NCT00295022|Secondary|Change From Baseline in the Individual Symptom Scores Over Period III|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]|Only patients with valid individual symptom scores in Period III were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277340|NCT00295022|Secondary|Change From Baseline in the Individual Symptom Scores Over Period II|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]|Only patients with valid individual symptom scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277341|NCT00295022|Secondary|Change From Baseline in the Individual Symptom Scores Over Period I|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid individual symptom scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277342|NCT00295022|Secondary|Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid TSC score + Nasal congestion score during the Total Treatment Period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277343|NCT00295022|Secondary|Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]|Only patients with valid TSC score + Nasal congestion score in Period III were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277361|NCT00294762|Primary|6-month Progression-free Survival|Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|6 months after first dose|All patients who received at least one dose of study drug.|||Percentage of Patients||95% Confidence Interval|Number
1277344|NCT00295022|Secondary|Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]|Only patients with valid TSC score + Nasal congestion score in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277345|NCT00295022|Secondary|Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid TSC score + Nasal congestion score in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277346|NCT00295022|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid TSC scores during the Total Treatment Period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277347|NCT00295022|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]|Only patients with valid TSC scores in Period III were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277348|NCT00295022|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]|Only patients with valid TSC scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277349|NCT00295022|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid TSC scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277362|NCT00294723|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 104-195|Safety analysis set is all subjects who entered the year 3 extension at week 104.|||episodes|||Number
1278183|NCT00289211|Secondary|Complement C4 Serum Levels|Change in complement C4 serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.|||mg/dL||Standard Deviation|Mean
1277350|NCT00295022|Secondary|Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid MSC scores during the Total Treatment Period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277351|NCT00295022|Secondary|Change From Baseline in the MSC Score Over Period III|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]|Only patients with valid MSC scores in Period III were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277352|NCT00295022|Secondary|Change From Baseline in the MSC Score Over Period II|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]|Only patients with valid MSC scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277353|NCT00295022|Primary|Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Efficacy variables were analyzed using the Intention-To-Treat (ITT) population. ITT consists of all randomized subjects who took at least one dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1277354|NCT00295009|Primary|Overall Success|"Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:~ODI score improved by at least 15% from baseline;~SF-36 score improved from baseline;~Neurologic parameters maintained or improved from baseline;~No re-operations required to modify or remove the implant; and~Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.~A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:~Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies"|60 Months|Patients who completed all 60 month visit analyses|||percentage of overall successes|||Number
1277355|NCT00295009|Primary|Overall Success|"Overall success was a composite endpoint.~A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:~ODI score improved by at least 15% from baseline;~SF-36 score improved from baseline;~Neurologic parameters maintained or improved from baseline;~No re-operations to modify or remove the implant; and~Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.~A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:~Same as above~Same as above~Same as above~No re-operations to modify the fusion site or correct a complication with an implant; and~Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies"|24 Months|Patients who completed all 24 month visit analyses|||percentage of overall successes|||Number
1277356|NCT00294762|Secondary|Duration of Tumor Response|Median length of time that tumor showed any type of response, ie, CR, PR, or SD|While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).|All patients who had any type of tumor response, ie, CR, PR, or SD|||Months||Full Range|Median
1277357|NCT00294762|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline|While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment|||Percent of Patients|||Number
1277358|NCT00294762|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death (maximum 29.0 months)|All patients who received at least 1 dose of study drug|||Months||Full Range|Median
1286689|NCT00168831|Secondary|Change From Baseline in Platelets|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1277363|NCT00294723|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 0-104|Full safety analysis set is all subjects who had been exposed to at least one dose of the study products.|||episodes|||Number
1277364|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156|Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277365|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104|Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277366|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52|Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277367|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point of total HbA1c||Standard Error|Least Squares Mean
1277368|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277369|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277370|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277371|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 156|Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277372|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 104|Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277373|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 52|Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
1277374|NCT00294723|Secondary|Change in Body Weight at Week 156|Change in body weight from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
1277375|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point of total HbA1c||Standard Error|Least Squares Mean
1277376|NCT00294723|Secondary|Change in Body Weight at Week 104|Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
1277377|NCT00294723|Secondary|Change in Body Weight at Week 52|Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
1277378|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point of total HbA1c||Standard Error|Least Squares Mean
1277379|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin A|Vitamin A sufficiency is measured by the molar ratio of serum retinol/retinol binding protein|12 months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
1277380|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin E|Vitamin E sufficiency is measured as the ratio of serum vitamin E/total lipids|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
1277381|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin K|Vitamin K sufficiency is measured by INR (international normalized ratio)|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
1277382|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin D|Vitamin D sufficiency is measured by the serum level of 25-hydroxy vitamin D|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
1277383|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin A|Vitamin A sufficiency is defined as the molar ratio of serum retinol/retinol binding protein|24 months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
1277384|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin D|Vitamin D sufficiency is measured by the serum level of 25-hydroxy vitamin D|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
1277385|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin K|Vitamin K sufficiency is measured by INR (international normalized ratio)|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
1277386|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin E|Vitamin E sufficiency is measured as the ratio of serum vitamin E/total lipids|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
1277387|NCT00294684|Secondary|Presence of Ascites at 24 Months||24 Months|Participants with their native liver at 24 months|||participants|||Number
1277388|NCT00294684|Secondary|Presence of Ascites at 12 Months||12 Months|Participants with their native liver at 12 months|||participants|||Number
1277389|NCT00294684|Secondary|Height Z-Score|Height by Age Z-score over the course of the study|HPE to age 24 Months||||Z-score||Standard Error|Mean
1277390|NCT00294684|Secondary|Weight Z-Score|weight for age Z-score (in subjects without ascites) over the course of the study|HPE until 24 months of age||||Z-score||Standard Error|Mean
1277391|NCT00294684|Secondary|Total Bilirubin Concentration at 24 Months of Age||At 24 Months of Age|Intent to treat patients with 24 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.|||mg/dL||Standard Deviation|Mean
1277392|NCT00294684|Secondary|Total Bilirubin Concentration at 12 Months||12 Months post HPE|Intent to treat patients with 12 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.|||mg/dL||Standard Deviation|Mean
1277393|NCT00294684|Secondary|Serum Total Bilirubin Concentration||Measurements will be made at 3 months after portoenterostomy|Intent to treat patients with 3 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.|||mg/dL||Standard Deviation|Mean
1277394|NCT00294684|Secondary|Survival With Native Liver at 24 Months of Age||Measurements will be made at 24 months of age|Intent to Treat|||percentage of participants|||Number
1277395|NCT00294684|Primary|The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy||Measurements will be made at 6 months after portoenterostomy|Intent to Treat|||percentage of participants|||Number
1277396|NCT00294671|Secondary|Quality of Life Questionnaire: SF-36 Mental Component Score|The 36 item short-form health survey (SF-36) was used to assess the difference between treatment groups for change of mental component scores over 2 years treatment. Range 0-100; lower scores reflect lower quality-of-life.|Baseline, 1 and 2 years||||units on a scale||95% Confidence Interval|Mean
1277397|NCT00294671|Secondary|Quality of Life Questionnaire: SF-36 Physical Component Score|The 36 item short-form health survey (SF-36) was used to assess the difference between treatment groups for change of physical component scores over 2 years treatment. Range 0-100; lower scores reflect lower quality-of-life.|Baseline, 1 and 2 years|Longitudinal analysis examined data from all 130 participants using intention-to-treat principles.|||units on a scale||95% Confidence Interval|Mean
1277398|NCT00294671|Secondary|Modified Body Mass Index (mBMI);|The product of body mass index (BMI) and serum albumin level (g/L) [kg/M2xg/L].|Baseline, 1 and 2 years||||kg/M2xg/L||95% Confidence Interval|Mean
1277399|NCT00294671|Secondary|Kumamoto Neurologic Scale;|Change from baseline of the Kumamoto Score (0-102 points, increasing with disease severity), a clinical neurologic scale of motor, sensory, and autonomic function combined with heart and kidney end organ measures developed to track disease progression in Familial Amyloid Polyneuropathy (ATTR-FAP)|Baseline, 1 and 2 years||||units on a scale||95% Confidence Interval|Mean
1277400|NCT00294671|Primary|Neurologic Impairment Score + 7 (NIS+7)|The primary endpoint, the difference in polyneuropathy progression between treatments, was measured by the Neuropathy Impairment Score plus 7 nerve tests (NIS+7) which ranges from 0 (no neurologic deficits) to 270 points (no detectable peripheral nerve function).|Baseline, 1 and 2 years|Longitudinal analysis examined data from all 130 participants using intention-to-treat principles.|||units on a scale||95% Confidence Interval|Mean
1277401|NCT00294658|Secondary|Treatment Associated Symptoms (TAS)|Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit.|Month 0, 1, 2, 3, 4 then every 3 months through Month 36|Patients were in and out by visit|||Participants|||Count of Participants
1277402|NCT00294658|Secondary|Treatment Associated Complications (TAC)|Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.|Month 0, 1, 2, 3, 4 then every 3 months through Month 36|Participants were in and out by each visit.|||Participants|||Count of Participants
1277403|NCT00294658|Secondary|Short Form-36 Standardized Mental Component|Range from 0 to 100, the higher the mental component value, the better the mental health.|Month 0, Month 12, Month 24 and Month 36|Participants were in and out by visit.|||units on a scale||Full Range|Median
1277404|NCT00294658|Secondary|Short Form-36 Standardized Physical Component|Range from 0 to 100, the higher the physical component value, the better the mental health.|Month 0, Month 12, Month 24 and Month 36|Participants were in and out by visit.|||units on a scale||Full Range|Median
1277405|NCT00294658|Secondary|Cumulative Days in Hospital for Myasthenia Gravis Exacerbation|Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)|baseline to 3 years||||days||Standard Deviation|Mean
1277406|NCT00294658|Secondary|Cumulative Days in Hospital for Myasthenia Gravis Exacerbation|Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)|baseline to 2 years||||days||Standard Deviation|Mean
1277407|NCT00294658|Secondary|Minimal Manifestation (MM) Status at Month 12, 24 and 36|Number of participants who were in minimal manifestation status at month 12, 24 and 36.|Month 12, 24 and 36|Number analyzed: Thymectomy plus prednisone: n=61 (Month 12), 59 (Month 24) , and 58 (Month 36); Prednisone alone n=54 (Month 12), 53 (Month 24), and 51 (Month 36)|||participants|||Number
1277408|NCT00294658|Secondary|Intravenous Immunoglobulin Use||baseline to 3 years||||participants|||Number
1277409|NCT00294658|Secondary|Plasma Exchange Use||baseline to 3 years||||participants|||Number
1277410|NCT00294658|Secondary|Azathioprine Use||baseline to 3 years||||participants|||Number
1277411|NCT00294658|Secondary|Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36|MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life.|Month 12, 24, and 36|Participants were in and out at month 12, 24 and 36 visit.|||units on a scale||Standard Deviation|Mean
1277412|NCT00294658|Secondary|Time-Weighted Average MG Activity of Daily Living (MG-ADL)|MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.|baseline, month 4, 6 and every 3 months through 36 months|Five participants in each group did not provide the information to enable calculation of the time-weighted average MG activity of daily life over 3 years.|||units on a scale||Standard Deviation|Mean
1277413|NCT00294658|Secondary|Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)|For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.|baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
1277532|NCT00293579|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years||||patients|||Number
1277414|NCT00294658|Secondary|Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)|For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
1277415|NCT00294658|Secondary|Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)|Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period.|baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted average prescribed alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
1277416|NCT00294658|Secondary|Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term|Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)|baseline to 3 years||||events|||Number
1277417|NCT00294658|Secondary|Cumulative Number of Hospital Days|Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)|baseline to 3 years||||days||Standard Deviation|Mean
1277418|NCT00294658|Secondary|Hospitalization for Exacerbation of Myasthenia Gravis||baseline to 2 years and baseline to 3 years|Number of participants who had hospitalized over 2 and 3 years|||participants|||Number
1277419|NCT00294658|Secondary|Classification of Serious Adverse Events||baseline to 3 years|One participant might had experienced more than one serious adverse event.|||participants|||Number
1277420|NCT00294658|Secondary|Number of Patients With at Least One Serious Adverse Events|Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)|baseline to 3 years||||participants|||Number
1277421|NCT00294658|Secondary|Number of Serious Adverse Events|Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)|baseline to 3 years||||events|||Number
1277422|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 2 in Thymectomy plus prednisone group and 4 in Prednisone alone group did not provide age at disease onset information.|||mg||Standard Deviation|Mean
1277423|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
1277424|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 1 in Prednisone alone group did not provide prednisone use at enrollment information.|||mg||Standard Deviation|Mean
1277425|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted average Quantitative Myasthenia Gravis Weakness Score over 3 years. Another 2 participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the age at disease onset information.|||units on a scale||Standard Deviation|Mean
1277426|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.|||units on a scale||Standard Deviation|Mean
1277427|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in Thymectomy plus prednisone and 5 in Prednisone alone group did not provide information to enable the calculation of Time-weighted average Quantitative Myasthenia Gravis Score by prednisone use at enrollment over 3 years.|||units on a scale||Standard Deviation|Mean
1277428|NCT00294658|Primary|Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
1277429|NCT00294658|Primary|Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.|||units on a scale||Standard Deviation|Mean
1277430|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
1277431|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
1277432|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.|||Percentage of participants|||Number
1277433|NCT00294645|Secondary|Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
1277434|NCT00294645|Secondary|Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.|||Percentage of participants|||Number
1277435|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment||||Percentage of participants|||Number
1277436|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|Analysis used subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.|||Percentage of participants|||Number
1277437|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
1277438|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
1277439|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months|Compare time to diagnosis in Control and Remote arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed vs other endpoint analyses.|||Percentage of participants|||Number
1277440|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months|Compare time to diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
1277441|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|Only participants without a history of Atrial Tachycardia/Atrial Fibrillation were included in analysis of this objective.|||Percentage of participants|||Number
1277442|NCT00294645|Secondary|Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events|Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other|One year post-enrollment||||Total number actions/total number CAEs|||Number
1277443|NCT00294645|Primary|Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months|Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.|One year post-enrollment||||Percentage of participants|||Number
1277444|NCT00294554|Primary|CIBIC-Plus Score|CIBIC-Plus is based upon clinicians’ observations of change in the patient’s cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. It takes into account a subject’s overall function in the cognitive, behavioral and functional activity domains. Scoring is based on an interview with the caregiver and examination of the patient by an independent evaluator, without consulting other information such as cognitive test results. It requires the assessor to consider a number of cognitive, functional, and behavioral areas prior to providing an overall “global” assessment of clinical change. 7-point categorical scale that provides a single global rating of change from baseline.A score of 1 indicates marked improvement;and a score of 7, marked worsening.|24 weeks||||Participants|||Count of Participants
1277445|NCT00294554|Primary|Change in Dementia Rating Scale (DRS) Memory Subscore|The DRS is comprised of: Attention (ATT, 8 items); Initiation-Perseveration (I-P, 11 items); Construction (CONST, 6 items); Conceptualization (CONCEPT, 6 items); and Memory (MEM, 5 items). For this study, only the memory subscore was used, with score possibilities ranging from 0-5, with 5 meaning memory was perfect, 0 being no ability to recall. A negative score indicates a decrease in memory from baseline to 24 weeks.|change from baseline to 24 weeks||||units on a scale||95% Confidence Interval|Mean
1277446|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.|24 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
1277447|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.|18 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
1277448|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.|9 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
1277449|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.|6 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
1277450|NCT00294515|Primary|Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.|12 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
1277451|NCT00294398|Secondary|Asthma-related Quality of Life|Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life.|2 months|Analysis population was based on the intention to treat number at enrollment.|||units on a scale||Standard Deviation|Mean
1277452|NCT00294398|Primary|Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)|Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.|2 months|Analysis population was based on the intention to treat number at enrollment.|||Participants|||Number
1277453|NCT00294060|Primary|Multiple In-clinic Visits|Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation|implant to one year|Only those patients with a dual chamber device completing 12 months of follow-up were included in this analysis.|||participants with 2 or more visits|||Number
1277454|NCT00294060|Primary|Days Hospitalized|Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year|implant to one year|Patients with a twelve-month follow-up visit were included in the analysis.|||average days hospitalized||Standard Deviation|Mean
1277455|NCT00294060|Primary|Number of Participants With Dual Chamber Devices|Pacemaker device choice characterized by the number of patients with dual chamber devices|at original implant||||Participants with dual chamber devices|||Number
1277456|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277457|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277458|NCT00294047|Secondary|Number of Subjects With First Colposcopy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277459|NCT00294047|Secondary|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277509|NCT00293722|Secondary|Change From Baseline in Patient Assessment of Pain at Week 52|Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277460|NCT00294047|Secondary|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277461|NCT00294047|Secondary|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection|Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277462|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status|CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277463|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen||Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277464|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277465|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277466|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277467|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.|Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1279966|NCT00270855|Secondary|Low Density Lipoprotein Cholesterol (LDL) Between Groups|Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
1277468|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277469|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277470|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if~the same HPV type was found in at least one of the two (closest) preceding cytology samples, or~none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types)"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277471|NCT00294047|Secondary|Number of Subjects With Pregnancies and Their Outcomes.|Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277472|NCT00294047|Secondary|Number of Subjects Reporting Medically Significant Conditions (MAEs).|Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277473|NCT00294047|Secondary|Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).||Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277474|NCT00294047|Secondary|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).|NOCDs include autoimmune disorders, asthma and type I diabetes.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277475|NCT00294047|Secondary|Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277476|NCT00294047|Secondary|Number of Subjects Reporting Related or Fatal Serious Adverse Event.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277477|NCT00294047|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.|Up to Month 48 and up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277533|NCT00293540|Primary|Overall Survival|Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.|Up to 9 years|Analyzed all patients with followup data|||years||95% Confidence Interval|Median
1277478|NCT00294047|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 unsolicited AE = an event that prevented normal activity.~A related AE = event assessed by the investigator as causally related to the study vaccination."|Within 30 days (Days 0 – 29) post-vaccination period.|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277479|NCT00294047|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C.|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.|||Participants|||Count of Participants
1277480|NCT00294047|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.|||Participants|||Count of Participants
1277481|NCT00294047|Secondary|Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.|"Titers are expressed as geometric mean antibody titers (GMTs).~Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination.~ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50%"|Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||Titers||95% Confidence Interval|Geometric Mean
1277482|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.|Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%|Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||Participants|||Count of Participants
1277483|NCT00294047|Secondary|Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.|"GMCs were expressed in ELISA units per milliliter (EL.U/mL).~Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1277484|NCT00294047|Secondary|Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.|"GMCs were expressed in ELISA units per milliliter (EL.U/mL).~Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1277485|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.|"Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites N≥1000, at least 250 per region"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||Participants|||Count of Participants
1277486|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.|"Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites N≥1000, at least 250 per region"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||Participants|||Count of Participants
1277487|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.~The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)"|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277488|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277489|NCT00294047|Secondary|Number of Subjects With First Colposcopy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277490|NCT00294047|Secondary|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277491|NCT00294047|Secondary|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.~HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277492|NCT00294047|Secondary|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~Results for seropositive status were not analysed."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277493|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA status."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277494|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1277510|NCT00293722|Secondary|Change From Baseline in Patient Assessment of Itching at Week 52|Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277495|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277496|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~Note: Results for seropositive status were not analysed."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277497|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.|"Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).~Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus.~HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277498|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.|"Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.~HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277499|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277500|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in:~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277511|NCT00293722|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1277501|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277502|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.|CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277503|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|"CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277504|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.|"CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)~Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
1277505|NCT00293813|Secondary|Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12|Cortical Thickness measured by XtremeCT.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1277506|NCT00293813|Primary|Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12|Cortical Thickness measured by XtremeCT.|12 months|Randomized subjects who receive at least 1 dose of investigational product and have a baseline and at least 1 post baseline evaluation before or at month 12. Last Observation Carried Forward used as imputation method. Summarised for actual treatment taken.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1277507|NCT00293722|Other Pre-specified|Change From Baseline in Patient Global Assessment of Disease Activity at Week 52|Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||millimeter||Standard Deviation|Mean
1277508|NCT00293722|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52|SF-12 questionnaire was used to determine participants’ quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277580|NCT00293267|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16|16 Weeks||||Percentage of Participants||95% Confidence Interval|Number
1277512|NCT00293722|Secondary|Number of Participants With Nail Involvement|Number of participants with psoriatic arthritis affecting the nails are reported.|Baseline, Week 12, 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||participants|||Number
1277513|NCT00293722|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 52|Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||millimeter||Standard Deviation|Mean
1277514|NCT00293722|Secondary|Change From Baseline in Ritchie Index at Week 52|Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant’s reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277515|NCT00293722|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277516|NCT00293722|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52||Baseline, Week 52|Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||percentage of BSA||Standard Deviation|Mean
1277517|NCT00293722|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Baseline up to Week 52|Safety analysis set included all participants who were enrolled in this study and had safety data available.|||percentage of participants|||Number
1277518|NCT00293709|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52|SF-12 questionnaire was used to determine participants’ quality of life (QoL). It comprised 12 items which covered 8 concepts : physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277519|NCT00293709|Secondary|Change From Baseline in Patient Assessment of Pain at Week 52|Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277520|NCT00293709|Secondary|Change From Baseline in Patient Assessment of Itching at Week 52|Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277531|NCT00293579|Secondary|Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer|Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 3 years||||percent of patients|||Number
1277521|NCT00293709|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1277522|NCT00293709|Secondary|Number of Participants With Nail Involvement|Number of participants with psoriatic arthritis affecting the nails are reported.|Baseline, Week 12, 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||participants|||Number
1277523|NCT00293709|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 52|Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||millimeter||Standard Deviation|Mean
1277524|NCT00293709|Secondary|Change From Baseline in Ritchie Index at Week 52|Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant’s reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277525|NCT00293709|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277526|NCT00293709|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52|PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI=sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease).|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
1277527|NCT00293709|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52||Baseline, Week 52|Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||percentage of BSA||Standard Deviation|Mean
1277528|NCT00293709|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Baseline up to Week 52|Safety analysis set included all participants who were enrolled in this study.|||percentage of participants|||Number
1277529|NCT00293579|Secondary|Overall Survival|Overall survival was measured from the time of initial study entry to death due to any cause.|Up to 2 years|All patients were deceased at the time of terminating this study.|||months||Full Range|Median
1277530|NCT00293579|Secondary|Impact of Pemetrexed Chemotherapy on Quality of Life|Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).|Baseline, End of Treatment [up to 3 years]||||Units on a scale||Standard Deviation|Mean
1277534|NCT00293462|Secondary|Pain Questionnaire|Severity and quality of pain by questionnaires (0-10 with higher scores indicating more pain) at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were averages together to compute one mean.|baseline through 3 months|Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.|||units on a scale||Standard Deviation|Mean
1277535|NCT00293462|Secondary|Functional Status by Karnofsky Performance Status Scale|Functional status by Karnofsky Performance Status Scale (0-100 with higher scores indicating better functional status) at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean.|baseline through 3 months|Of the intent to treat population, subjects who did not fill out the baseline Karnofsky functional scales were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.|||units on a scale||Standard Deviation|Mean
1277536|NCT00293462|Secondary|Quality of Life During Radiation Therapy|Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Quality of Life is measured with a scale that ranges from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean.|at baseline, during radiation therapy, and once a month for 3 months after radiation therapy|Of the intent to treat population, subjects who did not fill out the baseline quality of life questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.|||units on a scale||Standard Deviation|Mean
1277537|NCT00293462|Primary|Treatment Phase (Begins at Onset of Mucositis): Comparison of Three Groups to Evaluate the Effectiveness of the Two Mouthwashes.|To evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring. The number of days for mucositis to heal.|From onset of mucositis to healing of mucositis. Actual time variable. Mean: 95.8 days (SD 46.8)|Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash|||Healing Days||Standard Error|Mean
1277538|NCT00293462|Primary|Prevention Phase (Prior to Onset of Mucositis): Compare GG and SS Prior to Onset of Mucositis to Evaluate the Incidence of Radiation Therapy-induced Oral Mucositis|Incidence of grade 1 or 2 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy.|Prevention Phase (prior to onset of mucositis): Baseline to onset of mucositis. Actual time variable, mean time: 16.18 days (SD 7.4)|Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash|||participants|||Number
1277539|NCT00293397|Primary|Efficacy - Overall Survival|Presented are the counts of patients that have survived up to 2 years.|2 Years|20 patients were assessed.|||Participants|||Count of Participants
1277540|NCT00293397|Primary|Efficacy - Overall Survival|Presented are the counts of patients that have survived up to 1 year.|1 Year|20 patients were assessed.|||Participants|||Count of Participants
1277541|NCT00293397|Primary|Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, and at 6 months post treatment.~Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|6 months|19 of 20 patients were assessed.|||Participants|||Count of Participants
1277542|NCT00293397|Primary|Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 1 month post treatment.~Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|1 month|19 of 20 patients were assessed at 1 month.|||Participants|||Count of Participants
1277543|NCT00293397|Primary|Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria|"Efficacy as assessed by radiographic tumor response using EASL criteria at baseline and at 1 month post-TACE~Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions."|1 month|19 of 20 patients were assessed at 1 month.|||Participants|||Count of Participants
1277544|NCT00293397|Primary|Safety|Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.|6 months|19 of 20 patients were assessed at 6 months.|||Participants|||Count of Participants
1277545|NCT00293397|Primary|Safety|Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.|1 month|19 of 20 patients were assessed at 1 month.|||Participants|||Count of Participants
1277546|NCT00293384|Secondary|Toxicity Grade 3, 4, or 5||at 0-120 hours||||participants|||Number
1277547|NCT00293384|Other Pre-specified|Overall Nausea Controlled||at 0-120 hours||||participants|||Number
1277548|NCT00293384|Secondary|Delayed Vomiting Controlled||at 25-120 hours||||participants|||Number
1277549|NCT00293384|Primary|Proportion of Participants With Controlled Acute Vomiting|No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.|at 0-24 hours|Evaluable for response|||participants|||Number
1277550|NCT00293293|Secondary|Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM|Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||mg/dL||Standard Deviation|Mean
1286690|NCT00168831|Secondary|Change From Baseline in White Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/Litre (L)||Standard Deviation|Mean
1277551|NCT00293293|Secondary|Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM|Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3).|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||cells/mm^3||Standard Deviation|Mean
1277552|NCT00293293|Secondary|Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM|Determined from white blood cell counts collected during treatment phase of study; average applied.|Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)||||cells/mm^3||Standard Deviation|Mean
1277553|NCT00293293|Secondary|Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM|Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Participants|||Number
1277554|NCT00293293|Secondary|Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM|Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Participants|||Number
1277555|NCT00293293|Secondary|Average Natural Killer Cell Count Levels Before Chemotherapy and CAM|Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Cells per mm^3||Full Range|Mean
1277556|NCT00293293|Secondary|Average Natural Killer Cell Count Levels Before Chemotherapy Alone|Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Cells per mm^3||Full Range|Mean
1277557|NCT00293293|Secondary|Average Anti-Emetic Dose Use After Chemotherapy Plus CAM|Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Dose (mg) per participant||Standard Deviation|Mean
1277558|NCT00293293|Secondary|Average Anti-Emetic Dose Use After Chemotherapy Alone|Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Dose (mg) per participant||Standard Deviation|Mean
1277559|NCT00293293|Secondary|Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM|Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).|||Prescriptions per participant||Standard Deviation|Mean
1277560|NCT00293293|Secondary|Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone|Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|Patients that received 6 cycles of chemotherapy alone.|||Prescriptions per participant||Standard Deviation|Mean
1277561|NCT00293293|Secondary|Number of Patients With Delays In Receiving Chemotherapy Plus CAM|Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Participants|||Number
1277562|NCT00293293|Secondary|Number of Patients With Delays In Receiving Chemotherapy Alone|Number of patients who had to delay their chemotherapy treatments due to side effects.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||participants|||Number
1277563|NCT00293293|Primary|Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM|The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).|Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy||||Scores on a scale||Full Range|Mean
1277564|NCT00293293|Primary|Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)|Measured by Functional Assessment of Cancer Therapy—Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.|Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy||||Scores on a Scale||Full Range|Mean
1277565|NCT00293267|Secondary|Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm^3)|Baseline and Week 240|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
1277581|NCT00293267|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16|16 Weeks||||Percentage of Participants||95% Confidence Interval|Number
1277566|NCT00293267|Secondary|Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm^3)|Baseline and Week 156|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
1277567|NCT00293267|Primary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240|240 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses."|||Percentage of Participants||95% Confidence Interval|Number
1277568|NCT00293267|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3)|Baseline and Week 48|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
1277569|NCT00293267|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16|Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3)|Baseline and Week 16|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
1277570|NCT00293267|Primary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156|156 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."|||Percentage of Participants||95% Confidence Interval|Number
1277571|NCT00293267|Secondary|Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)|Baseline and Week 240|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1277572|NCT00293267|Secondary|Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)|Baseline and Week 156|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1277573|NCT00293267|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48|Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)|Baseline and Week 48|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1277574|NCT00293267|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16|Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)|Baseline and Week 16|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-~forward for all failures/discontinued due to lack of efficacy"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1277575|NCT00293267|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|156 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants|||Number
1277576|NCT00293267|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
1277577|NCT00293267|Secondary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240|240 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
1277578|NCT00293267|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156|156 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
1277579|NCT00293267|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
1277582|NCT00293254|Secondary|Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)|Baseline and Week 240|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (Cells/mm^3)||95% Confidence Interval|Mean
1277583|NCT00293254|Secondary|Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)|Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)|Baseline and Week 156|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
1277584|NCT00293254|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)|Baseline and Week 48|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
1277585|NCT00293254|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16|Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)|Baseline and Week 16|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
1277586|NCT00293254|Secondary|Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)|Baseline and Week 240|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1277587|NCT00293254|Secondary|Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)|Baseline and Week 156|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1277588|NCT00293254|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48|Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)|Baseline and Week 48|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1277589|NCT00293254|Secondary|Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16|Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)|Baseline and Week 16|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1277590|NCT00293254|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).|156 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants|||Number
1277591|NCT00293254|Secondary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240|240 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
1277592|NCT00293254|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156|156 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
1277593|NCT00293254|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
1277594|NCT00293254|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16|16 Weeks||||Percentage of Participants||95% Confidence Interval|Number
1277595|NCT00293254|Primary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240|240 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."|||Percentage of Participants||95% Confidence Interval|Number
1286691|NCT00168831|Secondary|Change From Baseline in Red Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^12/Litre (L)||Standard Deviation|Mean
1277596|NCT00293254|Primary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156|156 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."|||Percentage of Participants||95% Confidence Interval|Number
1277597|NCT00293254|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48|48 Weeks||||Percentage of Participants||95% Confidence Interval|Number
1277598|NCT00293254|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16|16 Weeks||||Percentage of Participants||95% Confidence Interval|Number
1277599|NCT00293241|Secondary|Health State|Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.|2 years post-implant|Patients with health evaluation completed at 24 months follow-up|||units on a Health State scale||Standard Deviation|Mean
1277600|NCT00293241|Secondary|Atrial Pacing Percentage|Endpoint: Cumulative percentage atrial pacing documented in the device memory|2 years post-implant||||percentage atrial pacing||Inter-Quartile Range|Median
1277601|NCT00293241|Secondary|Patient Symptoms|Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup|Implant to 2 years post-implant||||participants|||Number
1277602|NCT00293241|Secondary|Change in PR Interval, Change in QRS Duration and Change in P-wave Duration|Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU|Implant to 2 years post-implant||||milliseconds||Standard Deviation|Mean
1277603|NCT00293241|Secondary|Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients|Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication|Implant to 2 years post-implant||||participants|||Number
1277604|NCT00293241|Secondary|Duration of Cardiovascular Related Hospitalizations|Endpoint: Duration of Cardiovascular Hospitalizations per subject|Implant to 4 years post-implant|All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.|||Days of CV hospitalizations||Inter-Quartile Range|Median
1277605|NCT00293241|Secondary|Number of Cardiovascular Related Hospitalizations|Endpoint: Number of Cardiovascular hospitalizations per subject|Implant to 4 years post-implant|All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.|||Number of CV Hospitalizations||Inter-Quartile Range|Median
1277606|NCT00293241|Secondary|Stroke|Endpoint: Stroke|Implant to 2 years post-implant||||participants|||Number
1277607|NCT00293241|Secondary|Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant|Time to patient death from any cause|Implant to 2 years post-implant||||participants|||Number
1277608|NCT00293241|Secondary|Incidence of High Voltage Therapies|Endpoint: A high voltage therapy delivered|Implant to 2 years post-implant||||participants|||Number
1277609|NCT00293241|Secondary|Change in the Use of Cardiovascular Medication Over Time|Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant|Implant to 2 years post-implant||||participants|||Number
1277610|NCT00293241|Secondary|Change in Use of Anticoagulation|Endpoint: Use of Anticoagulation at enrollment and every follow-up visit|Implant to 2 years post-implant||||participants|||Number
1277611|NCT00293241|Secondary|Change in New York Heart Association (NYHA) Functional Class|"Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.~II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.~IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases."|Baseline, one year and 2 year post-implant||||Participants|||Number
1277612|NCT00293241|Secondary|Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time|Endpoint: LVEF (%) difference between 2 year post implant and baseline|Implant to 2 years post-implant||||LVEF (%) difference||Standard Deviation|Mean
1277613|NCT00293241|Secondary|Ventricular Pacing Percentage|Endpoint: Cumulative percentage ventricular pacing documented in the device memory|Implant to 2 years post-implant||||Percentage Ventricular Pacing||Inter-Quartile Range|Median
1277614|NCT00293241|Secondary|Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant|"Time to development of permanent AF fulfilling one of the following criteria:~7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or~7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient"|Implant to 2 years post-implant||||participants|||Number
1277615|NCT00293241|Secondary|Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant|"Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:~7 days in a row with device diagnostic showing 20 or more hours in AT/AF or~a cardioversion was done to terminate AT/AF or~the patient is during 2 consecutive follow-up (FU) visits in AT/AF"|Implant to 2 years post-implant||||participants|||Number
1277616|NCT00293241|Secondary|Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.|Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant|Implant to 2 years post-implant||||participants|||Number
1278819|NCT00283712|Secondary|Participant Response to Treatment at Week 18|Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <=10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.|Baseline to Week 18|Per-protocol|||Participants|||Number
1277617|NCT00293241|Primary|Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant|"Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.~Hospitalization is defined as:~admission to hospital involving one overnight stay or~emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition~Cardiovascular is defined as new or worsening:~heart failure (HF),~angina,~myocardial infarction (MI),~any arrhythmia,~stroke,~transient ischemic attack (TIA),~acute peripheral vascular emergencies,~pulmonary embolism."|Implant to 2 years post-implant|Patients indicated for Implantable Pulse Generator (IPG) or Implantable Cardioverter Defibrillator (ICD) replacement with a history of right ventricular pacing > 40%, to be allocated to either Managed Ventricular Pacing (MVP) programming, or conventional dual chamber programming (DDD) without MVP|||number of participants|||Number
1277618|NCT00293059|Post-Hoc|Change in Absolute Value From Baseline MBL to end-of Study MBL|The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.|||mL||Standard Deviation|Mean
1277619|NCT00293059|Post-Hoc|Proportion of Participants With Successful Treatment|End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.|||Proportion of participants|||Number
1277620|NCT00293059|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 196|Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data|||g/dL||Standard Deviation|Mean
1277621|NCT00293059|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 84|Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.|baseline and treatment day 84|ITT, excluding participants with missing data|||g/dL||Standard Deviation|Mean
1277622|NCT00293059|Secondary|Change From Baseline in Serum Ferritin Concentration at Treatment Day 196|Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data|||ng/mL||Standard Deviation|Mean
1277623|NCT00293059|Secondary|Change From Baseline in Serum Ferritin Concentration at Treatment Day 84|Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.|baseline and treatment day 84|ITT, excluding participants with missing data|||ng/mL||Standard Deviation|Mean
1277624|NCT00293059|Secondary|Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196|Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data|||Percentage of blood volume||Standard Deviation|Mean
1277625|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196|Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277626|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196|Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277627|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196|Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277628|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196|Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277629|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196|Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277630|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196|Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277658|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle.|28 days|ITT, participants with excessive bleeding at baseline|||mL||Standard Deviation|Mean
1277631|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196|Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities.|treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277632|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196|Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.|treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277633|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196|Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.|treatment day 196|ITT, excluding participants with missing data|||days||Standard Deviation|Mean
1277634|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196|Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277635|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84|Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277636|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84|Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277637|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84|Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277638|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84|Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277639|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84|Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277640|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84|Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277641|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84|Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.|treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277642|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84|Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.|treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277643|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84|Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.|treatment day 84|ITT, excluding participants with missing data|||day||Standard Deviation|Mean
1277644|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84|Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277645|NCT00293059|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196|The visual analogue scale (ie, “thermometer”) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented.|baseline and treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277646|NCT00293059|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84|The visual analogue scale (ie, “thermometer”) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented.|baseline and treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277647|NCT00293059|Secondary|Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196|The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented.|baseline and treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277648|NCT00293059|Secondary|Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84|The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented.|baseline and treatment day 84|ITT, excluding participants with missing data|||scores on a scale||Standard Deviation|Mean
1277649|NCT00293059|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196|The MFSQ was designed to measure aspects of female sexuality and asked about the participants’ sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.|baseline and treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277650|NCT00293059|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84|The MFSQ was designed to measure aspects of female sexuality and asked about the participants’ sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.|baseline and treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277651|NCT00293059|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|baseline and treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277652|NCT00293059|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|baseline and treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
1277653|NCT00293059|Secondary|Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment|The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data|||Sanitary protection products||Standard Deviation|Mean
1277654|NCT00293059|Secondary|Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment|A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data|||bleeding episodes||Standard Deviation|Mean
1277655|NCT00293059|Secondary|Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment|The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data|||bleeding days||Standard Deviation|Mean
1277656|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.|28 days|ITT, participants with excessive bleeding at baseline|||mL||Standard Deviation|Mean
1277657|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.|28 days|ITT, participants with excessive bleeding at baseline|||mL||Standard Deviation|Mean
1277659|NCT00293059|Secondary|Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.|baseline and reference period of 90 days under treatment|ITT, participants with excessive bleeding at baseline|||mL||Standard Deviation|Mean
1277660|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 7|Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles|28 days|ITT, excluding participants with missing data|||mL||Standard Deviation|Mean
1277661|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 3|Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles|28 days|ITT, excluding participants with missing data|||mL||Standard Deviation|Mean
1277662|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 1|Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle|28 days|ITT, excluding participants with missing data|||mL||Standard Deviation|Mean
1277663|NCT00293059|Secondary|Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment|Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.|Baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data|||mL||Standard Deviation|Mean
1277664|NCT00293059|Secondary|Proportion of Participants With Improvement in the Participant’s Overall Assessment Scale at Treatment Day 196|Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277665|NCT00293059|Secondary|Proportion of Participants With Improvement in the Participant’s Overall Assessment Scale at Treatment Day 84|Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277666|NCT00293059|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 196|The investigators assessed the participants’ change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277667|NCT00293059|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 84|The investigators assessed the participants’ change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
1277668|NCT00293059|Secondary|Proportion of Participants Cured From Excessive Bleeding|Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with excessive bleeding.|||Proportion of participants|||Number
1277669|NCT00293059|Secondary|Proportion of Participants Cured From Frequent Bleeding|Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with frequent bleeding.|||Proportion of participants|||Number
1277670|NCT00293059|Secondary|Proportion of Participants Cured From Prolonged Bleeding|Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with prolonged bleeding.|||Proportion of participants|||Number
1277671|NCT00293059|Primary|Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms|Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant’s total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in.|during a time period of 90 days under treatment|The intent-to-treat (ITT) group consisted of all randomized participants.|||Proportion of participants|||Number
1277760|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP) at Baseline|Plasma B-type Natriuretic Peptide (BNP) measured at basline|Baseline||||picograms per millilitre||Standard Deviation|Mean
1277672|NCT00293020|Primary|Percentage of Participants With Adverse Events.|After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.|Participants were followed for the duration of the study, an average of 126 days|All subjects that received at least 1 dose of study drug were included in the analysis.|||percentage of participants|||Number
1277673|NCT00292981|Secondary|Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)|Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.|Up to Day 9 following an attack|ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered.|||hours|Participants|95% Confidence Interval|Median
1277674|NCT00292981|Primary|Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)|The start of symptom relief was determined by subject self-assessment.|Up to 24 h after start of study treatment|ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered.|||hours|Participants|95% Confidence Interval|Median
1277675|NCT00292981|Secondary|Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)|Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.|Up to Day 9 following an attack|Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication.|||hours||95% Confidence Interval|Median
1277676|NCT00292981|Primary|Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)|The start of symptom relief was determined by subject self-assessment.|Up to 24 h after start of study treatment|Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication.|||hours||95% Confidence Interval|Median
1277677|NCT00292942|Secondary|Tmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (hr)|Tmax was calculated after single 2.0, 4.0 and 8.0 mg/kg dose of Artesunate daily for 3 days (hr)|Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion||||hr||Standard Deviation|Mean
1277678|NCT00292942|Secondary|Cmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)|Cmax was calculated after single 2.0, 4.0 and 8.0 mg/kg dose of Artesunate daily for 3 days (ng/mL)|Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion||||ng/mL||Standard Deviation|Mean
1277679|NCT00292942|Secondary|Range of Pharmacokinetic Parameters for Dihydroartemisinin (DHA) After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)|For DHA, AUC24, and AUClast were calculated for each dose, as well as the total area under the curve extrapolated to infinite time (AUC∞TOTAL), calculated as the sum of AUC24 for each dose +C24/λz.|Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion||||ng*hr/mL||Standard Deviation|Mean
1277680|NCT00292942|Secondary|Range of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)|For the predicted concentration at the time of dose administration (C0) was determine for each dose (ng/mL)|Pre-dose, 5, 20, 40 minutes after infusion and 1, 2, 4, 8, 24 and 72 hours after infusion||||ng/mL||Standard Deviation|Mean
1277681|NCT00292942|Secondary|Range of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)|For artesunic acid, AUC0-last was determine for each dose; as well as the total area under the curve (AUClastTOTAL), calculated as the sum of AUClast for each of the doses (ng*hr/mL)|Pre-dose, 5, 20, 40 minutes after infusion and 1, 2, 4, 8, 24 and 72 hours after infusion||||ng*hr/mL||Standard Deviation|Mean
1277682|NCT00292942|Secondary|Cardiovascular Responses: Number of Participants With Changes in Blood Pressure and Heart Rate After Infusion|Cardiovascular Responses: Number of participants with changes in blood pressure and heart rate after infusion to determine change from baseline|screening, on Day -1, on Days 1, 2, and 3, and at each follow-up visit||||Participants|||Count of Participants
1277683|NCT00292942|Primary|Number of Participants With AEs Occurring in Greater Frequency in the 2.0 mg/kg IV AS Group Then in the Placebo Group to Access Safety and Tolerability of AS|Comparison of number of participants with AEs reported for the placebo control and those treated with the 2.0 mg/kg of IV AS to access safety and tolerability|up to 21 days|As the intended, compassionate use dose of Intravenous Artesunate will be 2.4 mg/kg for the treatment of individuals with severe malaria, a comparison was performed between the frequency of AEs reported for the placebo control subjects and those treated with the 2.0 mg/kg dose of Intravenous Artesunate.|||Participants|||Count of Participants
1277684|NCT00292942|Primary|Number of Participants With AEs|The general strategy of the safety analysis was to examine the clinical tolerability and laboratory safety parameter data and determine if there were any trends amongst the dose levels concerning all AEs and drug related AEs.|up to 21 days||||Participants|||Count of Participants
1277685|NCT00292591|Primary|25-Hydroxyvitamin D Concentration|Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery|7 months||||ng/mL||Standard Deviation|Mean
1277686|NCT00292461|Secondary|Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.||Baseline and 16 weeks||||percentage of participants|||Number
1277687|NCT00292461|Secondary|Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period||Baseline and 16 weeks||||participants|||Number
1277688|NCT00292461|Secondary|Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period||Baseline and 16 weeks||||participants|||Number
1277689|NCT00292461|Primary|The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline|Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment|Baseline and 16 weeks|ITT (intent-to-treat)|||percent change||Full Range|Median
1277690|NCT00292370|Secondary|PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS||Baseline to endpoint change scores|||||||
1277761|NCT00292162|Primary|Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months|Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months|6 months||||percentage of blood ejected in one beat||Standard Deviation|Mean
1286692|NCT00168831|Secondary|Change From Baseline in Haemoglobin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||grams per litre (g/L)||Standard Deviation|Mean
1277691|NCT00292370|Primary|Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.|The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.|From baseline (week 8) to endpoint (week 16 or termination)||||units on a scale||Standard Deviation|Mean
1277692|NCT00292318|Secondary|Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure)|Measurement of pressure changes by a colonoscope as recorded by a manometric catheter connected to a Polygraph transducer.|The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.|Data were not collected due medical instruments to measure this outcome were removed by VA staff causing the study to be terminated.||||||
1277693|NCT00292318|Primary|"Patient Report of Adequate Relief From FI Symptoms With a Yes Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A Responder Will be Defined as One Who Provides a Yes Answer."|Only reporting the results of participants who reported adequate relief.|The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.|Only participants that completed the full number of study visits were analyzed.|||participants|||Number
1277694|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 10 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277695|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 9 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.|Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277696|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 8 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.|Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277697|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 7 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.|Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277698|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 6 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.|Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277699|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 5 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.|Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1278179|NCT00289276|Secondary|Number of Adverse Events|All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu|From enrollment to study exit (up to 36 months).|Number of participants analyzed for this outcome is limited to subjects who experienced at least one Adverse Event from enrollment to study exit.|||Adverse Events|||Number
1277700|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 4 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.|Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277701|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 3 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.|Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277702|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.|Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277703|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.|Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277704|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI at Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.|Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277705|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.|Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277706|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.|Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277707|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 24 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277762|NCT00292162|Primary|Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)|Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %|Baseline|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study|||percentage of blood ejected in one beat||Standard Deviation|Mean
1277708|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 23 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.|Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277709|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 22 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.|Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277710|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 21 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.|Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277711|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 20 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.|Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277712|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 19 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.|Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277713|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 18 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.|Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277714|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 17 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.|Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277715|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 16 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.|Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1278840|NCT00283400|Secondary|Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1|Number of subjects with good clinical outcome defined as a Glasgw Outcome Scale score of 0-1|3 months after enrollment||||participants|||Number
1277716|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 15 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.|Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277717|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 14 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.|Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277718|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 13 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.|Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277719|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 12 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.|Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277720|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 11 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 7:00h.|Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277721|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 10 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 6:00h.|Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277722|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 9 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 5:00h.|Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277723|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 8 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 4:00h.|Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1278629|NCT00286442|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.|||participants|||Number
1277724|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 7 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 3:00h.|Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277725|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 6 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 2:00h.|Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277726|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 5 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 1:00h.|Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277727|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 4 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 00:00h.|Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277728|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 3 Hours After Patch Application on Day 42(Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 23:00h.|Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277729|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 2 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 22:00h.|Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277730|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 1 Hour After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 21:00h.|Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1277731|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI at Time of Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
1278841|NCT00283400|Secondary|Serious Adverse Events|"Serious adverse events included neurological and medical complications and neurological deterioration.~Neurological deterioration was defined as a decline by more than 2 points in the Glasgow Coma Scale."|within 3 months after enrollment||||participants|||Number
1277732|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Total Score|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
1277733|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Frequency|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
1277734|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Severity|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.|||score on a scale||Standard Deviation|Mean
1277735|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
1277736|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
1277737|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
1277738|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 119, 121 for pregabalin, placebo respectively.|||particpants|||Number
1277739|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
1277740|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
1277741|NCT00292188|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score|Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.|Week 8|FAS. Number of subjects with a non-missing NPSI Total Intensity Score at Baseline and Week 8 (using LOCF) is 100, 106 for pregabalin, placebo respectively.|||percentage score on scale||Standard Error|Least Squares Mean
1277742|NCT00292188|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf)|Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.|Baseline, Week 8|Baseline; FAS, LOCF. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively.|||score on a scale||Standard Deviation|Mean
1277743|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Efficacy|Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
1277744|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics|Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
1278180|NCT00289276|Secondary|Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF|Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.|1 day pre and 1 day post-outpatient visit|All subjects with at least one heart failure outpatient treatment and with impedance data pre and post-outpatient treatment.|||Ohms||Full Range|Mean
1277745|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
1277746|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.|||score on a scale||Standard Deviation|Mean
1277747|NCT00292188|Secondary|Clinical Global Impression of Change (CGIC)|Clinical Global Impression of Change (CGIC): clinician’s judgment of overall change in the patient’s condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.|Week 8|FAS, LOCF|||participants|||Number
1277748|NCT00292188|Secondary|Patient Global Impression of Change (PGIC)|Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient’s overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.|Week 8|FAS, LOCF|||participants|||Number
1277749|NCT00292188|Secondary|Medical Outcome Study (MOS) Optimal Sleep|Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.|Week 8|FAS, LOCF.|||participants|||Number
1277750|NCT00292188|Secondary|Medical Outcome Study (MOS) Sleep Subscales|Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.|Week 8|FAS, LOCF. Number of subjects with evaluable data (n = pregabalin, placebo), respectively.|||score on a scale||Standard Error|Least Squares Mean
1277751|NCT00292188|Secondary|Weekly Mean Sleep Interference Score|11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.|Week 8|FAS, LOCF|||score on scale||Standard Error|Least Squares Mean
1277752|NCT00292188|Secondary|Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)|Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.|Baseline, Week 8|FAS, LOCF.|||participants|||Number
1277753|NCT00292188|Secondary|Weekly Mean Pain Score From Daily Pain Diary|Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.|Baseline through Week 8|FAS. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively|||score on scale||Standard Error|Least Squares Mean
1277754|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores|Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|Subset of subjects from the FAS who had moderate/severe baseline depression scores. LOCF.|||score on scale||Standard Error|Least Squares Mean
1277755|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores|Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety.|Week 8|Subset of subjects from the FAS who had moderate/severe baseline anxiety scores. LOCF.|||score on scale||Standard Error|Least Squares Mean
1277756|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Depression Score|Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (“lowering of hedonic tone”). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|FAS LOCF|||score on scale||Standard Error|Least Squares Mean
1277757|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Anxiety Score|Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety|Week 8|Full analysis set (FAS), last observation carried forward (LOCF)|||score on scale||Standard Error|Least Squares Mean
1277758|NCT00292188|Primary|Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary|Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.|each day of Week 8|Full Analysis Set (FAS): all randomized subjects who received >= 1 dose study drug & have post-randomization efficacy data. Last Observation Carried Forward (LOCF).|||score on a scale||Standard Error|Least Squares Mean
1277759|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP) at 6 Months|Plasma B-type Natriuretic Peptide (BNP)|6 months||||picograms per millilitre||Standard Deviation|Mean
1277763|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP)|venous blood taken to assess levels of the above peptide. High evels of the peptide are associated with adverse prognosis. Blood levels are taken at baseline and 6 months. The change over 6 months is assessed, thereore it is possible to have a negative number if the level falls.|baseline and 6 months|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate a blood test or dropped out of the study|||picograms per millilitre||Standard Deviation|Mean
1277764|NCT00292162|Primary|Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%|left ventricular ejection fraction (LVEF) is a measure of the % of blood ejected from the ventricle in one heart beat. It is a measure of cardiac function. We measured LVEF at baseline and at 6 months, to assess whether there had been a change in the patients cardiac function over time.|baseline and 6 months|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study|||percentage of blood ejected in one beat||Standard Deviation|Mean
1277765|NCT00291876|Secondary|Number of Subjects Reporting Pregnancies After Additional Vaccination|The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.|At Months 186 and 198|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subject|||Number
1277766|NCT00291876|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.~4 subjects received additional vaccination at Month 186 and 1 at Month 198."|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||subjects|||Number
1277767|NCT00291876|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|Analysis was performed on the Long Term Total cohort, on subjects with available data for the defined timepoint.|||Subjects|||Number
1277768|NCT00291876|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~4 subjects received additional vaccination at Month 186 and 1 at Month 198."|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||subjects|||Number
1277769|NCT00291876|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.~4 subjects received additional vaccination at Month 186 and 1 subject at Month 198."|During the 4-day (Days 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||subjects|||Number
1277770|NCT00291876|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.|During the 4-day (Days 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||subjects|||Number
1277771|NCT00291876|Secondary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.~Please note that value 14.9 means <15."|Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||mIU/mL|||Number
1277772|NCT00291876|Primary|Number of Seropositive Subjects Against Hepatitis A Virus|A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. *The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.|||Subjects|||Number
1277773|NCT00291876|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|"Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.~* The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging."|||mIU/mL||95% Confidence Interval|Geometric Mean
1277774|NCT00291694|Secondary|Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3|Change ion ratio.|baseline to 12 months||||ratio||Standard Error|Median
1277775|NCT00291694|Secondary|Serum Sex Hormone Binding Globulin (SHBG) Concentration|Change in serum concentration|Baseline to 12 months||||nmol/L||Standard Error|Median
1277776|NCT00291694|Secondary|Serum Estradiol Concentration|Change in serum estradiol concentration|Baseline to 12 months||||pg/ml||Standard Error|Median
1277777|NCT00291694|Secondary|Mammographic Breast Density|The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.|Baseline and 12 months|Subjects completing 12 months, with baseline and 12 month mammograms suitable for density analysis, such that a change in density over time can be computed|||percentage of breast area at increased d||Standard Error|Median
1277778|NCT00291694|Primary|Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67|Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.|Baseline and 12 months||||percentage of cells staining positive||Full Range|Median
1277779|NCT00291655|Secondary|Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months||Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months|Subjects with a discontinuation visit|||kg||Standard Deviation|Mean
1277780|NCT00291655|Primary|Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase|Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).|during open-label therapy phase of 18 months|Safety population that includes all subjects that have been treated once.|||participants|||Number
1277781|NCT00291642|Secondary|Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only subjects with valid individual symptom scores in Period I and II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277782|NCT00291642|Secondary|Change From Baseline in the Individual Symptom Scores Over Period II|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]|Only subjects with valid individual symptom scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277783|NCT00291642|Secondary|Change From Baseline in the Individual Symptom Scores Over Period I|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only subjects with valid individual symptom scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277784|NCT00291642|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid TSC scores in Period I and II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277795|NCT00291577|Secondary|Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment|Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study.|First dose of study treatment until at least 24 weeks on study|ITT; subjects with baseline assessments|||participants|||Number
1279069|NCT00282087|Secondary|Tolerability/Toxicity of This Regimen|Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.|Every 28 days during dosing and then every 3 months thereafter until patient comes off study||||number of major toxicity events|||Number
1277785|NCT00291642|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]|Only patients with valid TSC scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277786|NCT00291642|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid TSC scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277787|NCT00291642|Secondary|Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid MSC scores in Period I and II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277788|NCT00291642|Secondary|Change From Baseline in the MSC Score Over Period II|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]|Only patients with valid MSC scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277789|NCT00291642|Primary|Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid MSC scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1277790|NCT00291577|Primary|Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters|Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||hours||Standard Deviation|Mean
1277791|NCT00291577|Primary|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters|Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
1277792|NCT00291577|Primary|Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters|Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
1277793|NCT00291577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters|Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr.mL||Standard Deviation|Mean
1277794|NCT00291577|Secondary|Duration of Tumor Response Based on Investigator Assessment|Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.|Start of first confirmed CR or PR to first confirmed progression or death|ITT; subgroup of subjects with objective disease response|||weeks||95% Confidence Interval|Median
1277796|NCT00291577|Secondary|Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment|Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|First dose of study treatment until at least 4 weeks after confirmed response or partial response|ITT; subjects with baseline assessments|||participants|||Number
1277797|NCT00291577|Secondary|Progression-Free Survival (PFS) Based on Investigator Assessment|Median time (50 percent [%]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7.|First dose of study treatment until progressive disease|ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).|||weeks||95% Confidence Interval|Median
1277798|NCT00291577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters|Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
1277799|NCT00291577|Primary|Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters|Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng/mL||Standard Deviation|Mean
1277800|NCT00291577|Primary|Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters|Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||hours||Full Range|Median
1277801|NCT00291577|Primary|Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.|0 hour postdose|Evaluable set of subjects for PK analysis; (n) = Number of observations above lower limit of quantification (NALQ). No participants analyzed for SU011248 C1D2 and SU012662 C1D2; standard deviation for Total drug C1D2 confirmed as 0.00 (median, minimum, and maximum = 0.20).|||ng/mL||Standard Deviation|Mean
1277802|NCT00291577|Primary|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
1277803|NCT00291577|Primary|Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
1277804|NCT00291577|Primary|Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis|||ng/mL||Standard Deviation|Mean
1277805|NCT00291577|Primary|Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis is subjects in ITT population who completed sampling for PK profiles for both SU011248 and docetaxel; ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).|||hours||Full Range|Median
1277806|NCT00291551|Secondary|Number of Participants Who Died|Total number of patient deaths reported prior to study closure|Study duration|per protocol|||participants|||Number
1277807|NCT00291551|Secondary|Number of Adverse Events|Total adverse events reported prior to study closure|Study duration|per protocol|||events|||Number
1277808|NCT00291551|Secondary|Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score|The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death.|Baseline to 6 months|per protocol|||score on a scale||Standard Deviation|Mean
1277809|NCT00291551|Secondary|Changes in Cardiopulmonary Tests|Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months|Baseline to 6 months|per protocol|||ml/kg/min||Standard Deviation|Mean
1277810|NCT00291551|Secondary|Changes in 6 Minute Walk|Mean change in 6 minute walk distance (meters) between baseline and 6 months|Baseline to 6 months|per protocol|||meters||Standard Deviation|Mean
1277811|NCT00291551|Secondary|Change in Left Ventricular Mass|Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)|Baseline to 6 months||||grams||Standard Deviation|Mean
1277815|NCT00291551|Secondary|Change in NYHA Functional Class|"Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remains the same as baseline. Improved means the participant's functional class has improved (become lower in number) by at least one class. Worsened means the participatn's functional class has deteriorated (become higher in number) by at least one class."|Baseline to 6 months|per protocol|||participants|||Number
1277816|NCT00291551|Secondary|Implant Success (Number of Participants Successfully Implanted)|"Implant success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position."|1 day|per protocol|||participants|||Number
1277817|NCT00291551|Primary|Death or Additional Surgical Session at 6 Months||6 months|Per protocol|||participants|||Number
1277818|NCT00291343|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 15-24 Months of age up to Months 25-31 of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.|||Subjects|||Number
1277819|NCT00291343|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.|From Day 0 at months 15-24 of age to study end at Months 25-31 of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.|||Subjects|||Number
1277820|NCT00291343|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade.|During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.|||Subjects|||Number
1277821|NCT00291343|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.|During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.|||Subjects|||Number
1277822|NCT00291343|Secondary|Number of Subjects With Vaccine Response for rSBA-Men A, C|Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer < 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA > 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination.|1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1277823|NCT00291343|Secondary|Anti-HBs Concentrations|Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to the Mencevax ACWY vaccination at 24-30 Months of age|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1277824|NCT00291343|Secondary|Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs|The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).|Prior to the Mencevax ACWY vaccination at 24-30 Months of age|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1277825|NCT00291343|Secondary|Anti-PSA, Anti-PSC Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1277826|NCT00291343|Secondary|Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1277827|NCT00291343|Secondary|Anti-rSBA-MenA, C Antibody Titers|Antibody titers were expressed as Geometric Mean Titers (GMTs)|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1277885|NCT00290732|Primary|Maximum Tolerated Dose (MTD)|Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.|Until up to 30 days after PLD administration|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.|||milligrams|||Number
1277828|NCT00291343|Secondary|Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values|Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1277829|NCT00291343|Primary|Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies|Antibody cut-offs were higher than or equal to (≥) 1:128|1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).|The analyses were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1277830|NCT00291330|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.|||participants|||Number
1277831|NCT00291330|Secondary|Number of Participants With Acute Coronary Syndrome (ACS)|"Any ACS occurring during the conduct of the study (centrally adjudicated as definite).~Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|From first intake of study drug to end of study conduct|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.|||participants|||Number
1277832|NCT00291330|Secondary|Number of Participants With Bleeding Events|"Major bleeding events (MBE) were defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) was defined as~spontaneous skin hematoma >=25 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than spotting on toilet paper)~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.|||participants|||Number
1277833|NCT00291330|Secondary|Number of Participants Who Died (Any Cause)|Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
1277834|NCT00291330|Secondary|Number of Participants Who Died Due to VTE|"VTE - related deaths which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
1277835|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic Non-fatal PE|"Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
1277836|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic DVT|"Symptomatic DVT which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
1279070|NCT00282087|Primary|Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS||Every 3 months up to two years||||percentage of participants||95% Confidence Interval|Number
1277837|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic VTE and All Deaths|"VTE or any death which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||Participants|||Number
1277838|NCT00291330|Primary|Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE|All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||Participants|||Number
1277839|NCT00291317|Primary|Change in Bone Mineral Density Measured Via DEXA Scan|Bone mineral density (BMD) was measured with Dual X-ray Absorptiometry (DEXA) scans using a GE LUNAR system. DEXA has been used in patients with loss of ambulation due to SCI to monitor changes in body composition over time and to evaluate the effectiveness of exercise in preventing or reducing the disease-related complications of SCI. It was used in the present study to determine BMD in the right distal femur at baseline; after 3 months of intervention; after 6 months; and for children who biked for the full duration of the study, at the completion of 9 months of intervention.|At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness)||||g/cm^2||Standard Deviation|Mean
1277840|NCT00291317|Primary|Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.|The PedsQL™ 4.0 is a modular instrument for measuring health-related quality of life in children and adolescents. The questionnaire asks how much of a problem each item has been during the past month, using a 5-point response scale. This study used the Emotional Functioning, Social Functioning, and School Functioning modules. Scores on these three modules are combined to yield a Psychosocial Health Summary Score (range = 0-100 with 100 being the maximum positive outcome). Pre- and post-intervention scores were compared to determine improvement.|pre- and post-intervention; time frame among participants ranged from 4 to 12 months|Four of the six participants completed the PedsQL on at least 2 occasions. At minimum, each completed the PedsQL at their initial evaluation before beginning the cycling program and at or following their last cycling session.|||units on a scale||Standard Deviation|Mean
1277841|NCT00291226|Primary|Change in Scale of Prodromal Symptoms Total Score|Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0–6, with 0–2 being the normal range, 3–5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.|Change from Baseline at 8 Weeks||||units on a scale||Standard Deviation|Mean
1277842|NCT00291226|Primary|Scale of Prodromal Symptoms Total Score|Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0–6, with 0–2 being the normal range, 3–5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1277843|NCT00291187|Post-Hoc|Average Improvement in Latency to Non-awake (LNA)|The average improvement in latency to non-awake (length of time elapsed between lights off and first epoch of sleep determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.|||Minutes||Standard Error|Mean
1277844|NCT00291187|Post-Hoc|Average Improvement in Total Sleep Time (TST)|The average improvement in Total sleep time (determined by PSG and defined as the number of non-wake minutes between lights off and lights on) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.|||Minutes||Standard Error|Mean
1277845|NCT00291187|Secondary|Average Improvement of Wake After Sleep Onset (WASO)|The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.|||minutes||Standard Error|Mean
1286693|NCT00168831|Secondary|Change From Baseline in Haematocrit, Packed Cell Volume (PCV)||Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||Percentage of erythrocytes||Standard Deviation|Mean
1277846|NCT00291187|Primary|Average Improvement of Latency to Persistent Sleep (LPS)|The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.|||minutes||Standard Error|Mean
1277847|NCT00291161|Primary|Veteran Outcomes|The following outcomes were measured for veterans via scales administered to each veteran: Unmet need (range=0 to 24, higher meaning more unmet needs); Embarrassment about memory problems (range=0-3, higher indicating greater embarrassment); Isolation (range=0-4, higher indicating greater isolation); Relationship strain (range=0-4, higher indicating greater relationship strain); Depression (range=0-11, higher indicating greater depression).|Baseline - six months|Data were collected for veterans who could be interviewed only.|||units on a scale||Standard Deviation|Mean
1277848|NCT00291161|Primary|Caregiver Outcomes|The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)|Baseline and at six months|Data were collected for caregivers only|||units on a scale||Standard Deviation|Mean
1277849|NCT00291135|Primary|Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.|Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.|Baseline, 6 months|All subjects completed study and were used for analysis|||Change in % of cells positive for Ki-67||Full Range|Median
1277850|NCT00291018|Secondary|Surgery Again|% of subjects who would opt to have the surgery again if given the choice at 84 months|84 Months|Subjects who completed this questionnaire at 84 months|||% of Subjects|||Number
1277851|NCT00291018|Secondary|VAS Arm Pain Frequency|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of None of the Time [Arm] Pain at 0mm and All of the Time [Arm] Pain at 100mm."|84 Months|Subjects who completed the VAS Arm Pain Frequency Questionnaire at 84 Months|||% of Subjects|||Number
1277852|NCT00291018|Secondary|VAS Arm Pain Intensity|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No [Arm] Pain at 0mm and Worst [Arm] Pain Possible at 100mm."|84 Months|Subjects who completed the VAS Arm Pain Intensity Questionnaire at 84 Months|||% of Subjects|||Number
1277853|NCT00291018|Secondary|VAS Neck Pain Frequency|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of None of the Time [Neck] Pain at 0mm and All of the Time [Neck] Pain at 100mm."|84 Months|Subjects who completed the VAS Neck Pain Frequency Questionnaire at 84 Months|||% of Subjects|||Number
1277854|NCT00291018|Secondary|VAS Neck Pain Intensity|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No [Neck] Pain at 0mm and Worst [Neck] Pain Possible at 100mm."|84 Months|Subjects who completed the VAS Neck Pain Intensity Questionnaire at 84 Months|||% of Subjects|||Number
1277855|NCT00291018|Secondary|VAS Satisfaction|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No Satisfaction [with the surgery/outcome] at 0mm and Complete Satisfaction [with the surgery/outcome] at 100mm."|84 Months|Subjects who completed the VAS Satisfaction Questionnaire at 84 Months|||||Standard Deviation|Mean
1277856|NCT00291018|Secondary|SF-36 Mental Composite Score (MCS)|"The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.~It can take patients at least half an hour to complete the SF-36.~The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions."|84 Months|Subjects who completed the SF-36 questionnaire at 84 Months|||% of Subjects|||Number
1277857|NCT00291018|Secondary|SF-36 Physical Composite Score (PCS)|"The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.~It can take patients at least half an hour to complete the SF-36.~The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions."|84 Months|Subjects who completed the SF-36 questionnaire at 84 Months|||% of Subjects|||Number
1277886|NCT00290693|Secondary|Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy|Number of study participants experiencing toxicity (serious adverse events or adverse events). Study participants assessed for this outcome measure must have received at least one dose of protocol therapy. Toxicity assessed according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).|Up to 1 year|Study participants who received at least one dose of protocol therapy.|||participants|||Number
1277858|NCT00291018|Secondary|NDI|"NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain.~The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation.~Mean duration of the test is 3-8 minutes and the results can be interpreted as:~0-4 points (0-8%) no disability;~5-14 points (10-28%) mild disability;~15-24 points (30-48%) moderate disability;~25-34 points (50-64%) severe disability;~35-50 points (70-100%) complete disability"|84 months|Completed the NDI Questionnaire at 84 Months|||% of Subjects|||Number
1277859|NCT00291018|Secondary|Neurologic Success|% of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value)|84 months|"Subjects who were per protocol excluding device failures"|||% of Subjects|||Number
1277860|NCT00291018|Primary|Overall Success|Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material|84 Months|Subjects with data at 84 months|||% of Subjects|||Number
1277861|NCT00290888|Secondary|Upper Extremity Strength Grading||24 months|||||||
1277862|NCT00290888|Secondary|Shoulder Range of Motion||24 months|||||||
1277863|NCT00290888|Primary|American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)|Calculated as a percentage with an increase in score reflecting an improvement in outcome.|24 months||||percentage of total score||Standard Deviation|Mean
1277864|NCT00290888|Primary|Western Ontario Rotator Cuff Index (WORC)|Calculated as percentage with an increase in score indicating an improvement in outcome.|24 months||||percentage of total score||Standard Deviation|Mean
1277865|NCT00290810|Secondary|Time to Progression|"Progression is defined as one of the following:~A ≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥2 cm) or the appearance of new palpable lymph nodes, or~A ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or the appearance of hepatomegaly or splenomegaly which was not previously present, or~The transformation to a more aggressive histology (e.g. Richter’s transformation), or~A ≥ 50% increase in the absolute number of circulating lymphocytes.~The Kaplan-Meier method will be used to estimate time to progression."|From the date of registration to the date of the event (i.e., death or disease progression) or the date of last follow-up, up to 5 years||||months||95% Confidence Interval|Median
1277866|NCT00290810|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate distributions in the B-CLL population.|From the date of registration to the date of the event (i.e., death or the date of last follow-up), up to 5 years.||||months||95% Confidence Interval|Median
1277867|NCT00290810|Secondary|Toxicity Associated With This Regimen in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).|As per NCI Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The number of participants experiencing grade 3 or higher toxicity will be reported here.|From the date of registration to the to the date of last treatment evaluation, median number of days on treatment was 56 days.|All 12 participants treated will be used to analyze this endpoint.|||participants|||Number
1277868|NCT00290810|Primary|Number of Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR).|"The NCI Working Group criteria will be used to assess response to therapy. A confirmed response is defined as a response documented on 2 consecutive evaluations at least 4 weeks apart.~Complete Response:~No lymphadenopathy~No hepatomegaly or splenomegaly~Absense of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets > 100,000/ul~Hemoglobin > 11.0 gm/dl~Peripheral blood lymphocytes ≤ 4000/uL.~Confirmation by Marrow Aspirate and biopsy.~Complete Clinical Response:~-CR without bone marrow biopsy confirmation.~Nodular Partial Response:~-CR with the presence of residual clonal nodules.~Partial Response requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul~Hemoglobin >11.0 gm/dl"|Up to 5 years|All 12 patients are used in this analysis|||participants|||Number
1277869|NCT00290771|Secondary|Number of Patients With at Least 1 Adverse Event|An adverse event (AE) is any undesirable sign, symptom, or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. Study drug refers to imatinib or hydroxyurea. The study treatment is the combination of these two study drugs.|Baseline to end of study (Month 24)|Safety population: All patients who received at least 1 dose of either of the 2 study drugs and who had at least 1 post-baseline safety assessment.|||Participants|||Number
1277870|NCT00290771|Secondary|Percentage of Patients Surviving at Months 6, 12, and 24|Patients not known to have died were censored at the time of last survival follow-up.|Months 6, 12, and 24|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Percentage of participants||95% Confidence Interval|Number
1277871|NCT00290771|Secondary|Percentage of Patients With Progression-free Survival at Months 6 and 12|Progression-free survival (PFS) was defined as the time from the start of treatment to the date of the first documented disease progression (PD) or death due to any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, progression-free survival was censored at the time of the last overall response assessment.|Months 6 and 12|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Percentage of participants||95% Confidence Interval|Number
1277872|NCT00290771|Secondary|Percentage of Patients Who Had Clinical Benefit|Patients who had clinical benefit were patients with a best response of complete response (CR), partial response (PR), or stable disease (SD) lasting for more than 6 months from the start of treatment until the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. SD was defined as insufficient tumor shrinkage to qualify for PR or CR and no increase in lesions which would qualify as PD.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Percentage of participants||95% Confidence Interval|Number
1277873|NCT00290771|Secondary|Duration of Objective Overall Response (OOR)|Duration of OOR only included patients whose best overall response was complete response (CR) or partial response (PR). The start date was the date of the first documented response (CR or PR); the end date was the date of the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, the duration of OOR was censored at the time of the last OOR assessment.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Weeks||95% Confidence Interval|Median
1277874|NCT00290771|Primary|Percentage of Patients With an Objective Overall Response (OOR)|Patients with an OOR were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed with magnetic resonance imaging. A patient had a CR if the target tumors disappeared. A patient had a PR if there was a ≥ 50% reduction in the sum of the products of the largest perpendicular diameters of the target tumors compared to the baseline value. A best response of CR required at least 2 determinations of CR at least 4 weeks apart. A best response of PR required at least 2 determinations of PR or better at least 4 weeks apart (and not qualifying for CR).|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Percentage of participants||95% Confidence Interval|Number
1277875|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2|Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 month - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in ps2 concentration available for 44 participants. Analysis performed by menopause and cancer status.|||ng/ml||Standard Deviation|Mean
1277876|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D|Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in Cathespin D concentration available for 44 participants. Analysis performed by menopause and cancer status.|||mg/ml||Standard Deviation|Mean
1277877|NCT00290758|Secondary|Plasma Concentration of Sex Hormone Binding Globulin (SHBG)||6 months - baseline|Plasma concentration of SHBG was not available for 1 patient in Arm A. Analysis performed by menopause and cancer status.|||nmol/L||Standard Deviation|Mean
1277878|NCT00290758|Secondary|Monitor Drug Delivery by Measuring Plasma Genistein by HPLC|Drug delivery is measured be concentration of genistein in plasma using High Performance Liquid Chromatography (HPLC). Mean change in concentration of plasma genistein is assessed from baseline to 6 month follow up.|6 months - baseline|Analysis performed by menopause and cancer status.|||ng/ml||Standard Deviation|Median
1277879|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol|Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in estradiol concentration available for 40 participants. Analysis performed by menopause and cancer status.|||pg/ml||Standard Deviation|Mean
1277880|NCT00290758|Secondary|Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.|"Cytologic atypia evaluation was performed on Papanicolau stained Thin Prep slides using standard criteria, which were also used for spectral spatial imaging. Cell clusters were used to generate image stacks with the Nuance LCTF-based imaging system (CRI Inc). The image data was collected as percent pixels assigned as “atypical”. Mean change in the percent pixels assigned atypical is assessed from baseline to 6 month follow up."|6 months - baseline|Analysis performed by menopause and cancer status.|||Percent pixels||Standard Deviation|Mean
1277881|NCT00290758|Secondary|Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)|Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in EGF concentration available for 43 participants. Analysis performed by menopause and cancer status.|||ng/ml||Standard Deviation|Mean
1277882|NCT00290758|Primary|Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling|Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.|6 months - baseline|Participants who had more than 4,000 epithelial cells in rFNA samples at both baseline and 6 month follow up, met the criteria for compliance, and were available for evaluation of Ki-67 labeling index at both time points. Analysis performed by menopause and cancer status.|||Ki-67 labeling index||Standard Deviation|Mean
1277883|NCT00290732|Secondary|Concentrations of Doxorubicin in Tissue at Definitive Surgery|Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in tissue across all the participants in each group is reported.|Day of surgery/biopsy|Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.|||nmol/g|||Number
1277884|NCT00290732|Secondary|Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery|Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in blood (plasma) across all the participants in each group is reported.|Baseline, 4 hrs, day2/24 hrs, day 8, day of surgery/biopsy|Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.|||nM|||Number
1277887|NCT00290693|Secondary|Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels|Rate of participants achieving a 50% or more reduction in CA 19-9 levels after receiving protocol therapy. Baseline CA-19-9 will be compared to the lowest recorded value on patients receiving therapy on protocol. A 50% drop in CA 19-9 in patients with baseline levels above 100 U/ml will be recorded as a CA 19-9 response if the > 50% drop can be confirmed with at least one more CA 19-9 level thereafter with > 50% drop compared to baseline.|Up to 1 year|Participants who had available baseline CA19-9 levels above 100 U/ml.|||percentage of participants|||Number
1277888|NCT00290693|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is measured the time from the start of protocol therapy to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 1 year|Number of participants who completed at least one cycle of protocol therapy.|||months||95% Confidence Interval|Median
1277889|NCT00290693|Secondary|Overall Surival (OS)|Overall survival is measured from the time from date of initial protocol therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up.|Up to 1 year|Number of participants who completed at least one cycle of protocol therapy.|||months||95% Confidence Interval|Median
1277890|NCT00290693|Primary|Rate of Participants Achieving Complete Response or Partial Response to Therapy.|Rate of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 1 year|Number of participants evaluable for response, that is, who completed at least one cycle of protocol therapy.|||participants|||Number
1277891|NCT00290654|Secondary|Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|12 months after treatment||||percentage of participants|||Number
1277892|NCT00290654|Secondary|Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|6 months after treatment||||percentage of participants|||Number
1277893|NCT00290654|Secondary|Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|12 months after treatment||||percentage of physicians|||Number
1277894|NCT00290654|Secondary|Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|6 months after treatment||||percentage of physicians|||Number
1277895|NCT00290654|Secondary|Percentage of Patients Who Experienced Complications|Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.|more than 6 months after treatment, for up to 5 years||||percentage of participants|||Number
1277896|NCT00290654|Secondary|Percentage of Patients Who Experienced Complications|Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.|within 6 months of treatment||||percentage of participants|||Number
1277897|NCT00290654|Primary|Number of Patients With Ipsilateral Breast Tumor Recurrence|Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.|5 years after treatment||||participants|||Number
1277898|NCT00290654|Primary|Number of Patients With Ipsilateral Breast Tumor Recurrence|Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.|1 year after treatment||||participants|||Number
1277899|NCT00290615|Secondary|Overall Survival|Average months of survival of participants after receiving study drug.|From time of treatment until death from any cause, assesed up to 60 months.||||months||95% Confidence Interval|Median
1277900|NCT00290615|Other Pre-specified|Effect on Wound Angiogenesis||After study completion|||||||
1277901|NCT00290615|Other Pre-specified|Effect on Angiogenesis Biomarkers||After study completion|||||||
1277902|NCT00290615|Secondary|Progression-free Survival|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~This is the average number of months participants survived without showing progressive disease."|From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.||||months||95% Confidence Interval|Median
1277904|NCT00290615|Primary|Response Rate (Percentage of Participants With Partial or Complete Response)|"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.~Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~The definitions were:~Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.|All subjects who received restaging scans were analyzed.|||percentage of participants with response||95% Confidence Interval|Number
1277905|NCT00290537|Primary|Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)|Evaluate the response rate in patients receiving monotherapy with ZD6474 compared to ZD6474 plus carboplatin plus paclitaxel. No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfil the recruitment target.|Radiologic evaluations performed after weeks 2 and 9 of treatment, then every 2 cycles or as indicated if progressive disease is suspected up to 6 cycles or 18 weeks (1 cycle = 3 weeks).||||Participants|||Number
1277906|NCT00290472|Primary|Overall Survival|The overall survival was evaluated using the Kaplan-Meier estimator.|Up to 6 years||||Month||95% Confidence Interval|Median
1277907|NCT00290472|Primary|Duration of Response|Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|Up to 6 years||||Month||95% Confidence Interval|Median
1277908|NCT00290472|Primary|Objective Overall Response Rate|The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.|Up to 6 years||||percentage of participants|||Number
1277909|NCT00290407|Secondary|Blood Specimens Will be Collected to Measure Immunologic Effect||at weeks 4, 8, 12, and at month 6|||||||
1277910|NCT00290407|Primary|CT Scan to Measure Clinical Effect (Response)|Study terminated, results data not available|3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression|||||||
1277911|NCT00290342|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 5)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1277912|NCT00290342|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1277913|NCT00290342|Secondary|Number of Subjects Reporting Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = symptom symptoms considered by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.|||Subjects|||Number
1277914|NCT00290342|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.|||Subjects|||Number
1277915|NCT00290342|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|Before (Pre) and one month after (Post) the primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1277991|NCT00289900|Secondary|Percentage Change From Baseline in Apo A-I|Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
1277916|NCT00290342|Secondary|Titers for Poliovirus Type 1, 2 and 3 Antibodies|Titers for anti-polio 1, 2 and 3 are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was greater than or equal to (≥) 8.|Before (Pre) and one month after (Post) the primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1277917|NCT00290342|Secondary|Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (mIU/mL).|Before (Pre) and one month after (Post) the primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1277918|NCT00290342|Secondary|Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)|A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 1 international units/milliliter (IU//mL).|Before (Pre) and one month after (Post) the primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1277919|NCT00290342|Primary|Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens|Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations < 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).|One month (Month 5) post-primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1277920|NCT00290342|Primary|Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)|Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.|One month (Month 5) post-primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1277921|NCT00290342|Primary|Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.|One month (Month 5) post-primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1277922|NCT00290342|Primary|Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)|A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).|One month (Month 5) post-primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1277923|NCT00290329|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1277924|NCT00290329|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1277925|NCT00290329|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom reported irrespective of intensity grade and causal relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1277963|NCT00289991|Secondary|Time to Breakthrough Invasive Fungal Infection (IFI)|Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) worksheets (not on Case Report Forms or in the database). Times were summarized only for subjects who experienced a breakthrough IFI.|||days||95% Confidence Interval|Mean
1277926|NCT00290329|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1277927|NCT00290329|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Adverse Events|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site (Mencevax ACWY 2-5 YOA Group) and beyond 50 millimeters (mm) of injection site (Mencevax ACWY 6-17 YOA Group and Mencevax ACWY ≥ 18 YOA Group).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1277928|NCT00290329|Primary|Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1277929|NCT00290290|Primary|The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds.|The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.|during surgery and within the 30 days post surgery||||Percentage of Post Operative Infections|||Number
1277930|NCT00290251|Secondary|Quality of Life|The short form-36 (SF-36)and Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaires were given before and at treatment end with scales of 0 - 100. SF-36 scales = mental and physical well-being. The UFS subscales are symptom severity, concern, activities, energy and mood, control, self-consciousness, sexual functioning compiled into an overall QOL score. Higher results indicate better QOL on all but symptom severity (higher = worse). The change in scores from baseline to end of treatment was calculated.|3 months (Baseline to end of treatment 1)|All completers received a questionnaire at the end of the three-month study. One woman in the placebo group did not complete the questionnaire.|||units on a scale||Standard Error|Mean
1277931|NCT00290251|Primary|Shrinkage of Fibroids - Size of Fibroids|The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.|3 months (baseline to end of treatment)|Per protocol, including women with two MRIs regardless of whether they took all study medication|||logcm3||Standard Error|Mean
1277932|NCT00290238|Secondary|Total Expenditure Per Day on All Lower Back Pain Related Interventions|Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers’ Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.|Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12|Analysis population was intention to treat (ITT).|||Dollars||Full Range|Median
1277933|NCT00290238|Primary|Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score|"Visual analog scale (VAS) for pain (100mm line with 0/No pain on the left and 100/Worst pain imaginable on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits."|Time-averaged from the first available observation to the last available observation (12 months for completed subjects)|Analysis population was intention to treat (ITT), excluding subjects who had no follow-up (after the initial 10-week treatment phase) data available.|||mm||Standard Error|Least Squares Mean
1277934|NCT00290199|Secondary|Induction to Vaginal Delivery Interval|Mean hours from time of induction to vaginal delivery interval.|time from induction to vaginal delivery, up to 24 hours||||hours||Standard Deviation|Mean
1277935|NCT00290199|Secondary|Cesarean Rate|The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.|at delivery||||percentage of subjects|||Number
1277936|NCT00290199|Secondary|Rate of Delivery (Vaginal or Cesarean)by 24 Hours|The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.|from start of induction to 24 hours post start of induction||||percentage of deliveries|||Number
1277937|NCT00290199|Primary|Hours From Placement of Foley or Initiation of Oxytocin to Delivery|The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)|Time from induction to delivery||||hours||Standard Deviation|Mean
1277938|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time Variability in Milliseconds|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the variability in processing time in milliseconds that it takes to correctly respond to a target. Response time variability = the standard deviation of response times for correct responses. Lower values represent less variability and better responses. Range of response times = 0-2000 milliseconds.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||time in milliseconds||95% Confidence Interval|Mean
1277939|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time in Milliseconds|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the processing time in milliseconds that it takes to correctly respond to a target. Lower times represent better response times. Range = 0 - 2000 milliseconds|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||time in milliseconds||95% Confidence Interval|Mean
1277940|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Nonresponses.|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly not selected (number of times a child correctly refrains from hitting a buzzer) when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct nonresponses.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||Number of correct nonresponses||95% Confidence Interval|Mean
1277941|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Responses.|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly selected when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct responses.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||number of correct responses||95% Confidence Interval|Mean
1277942|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Social Function|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 5 items of daily activity grouped under social function. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-25 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277943|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Mobility|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 7 items of daily activity grouped under mobilityare. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-35 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277944|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Self-care|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 8 items of daily activity grouped under self-care. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-40 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1279909|NCT00271544|Primary|Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)|Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])|Three Months|Subjects with pacing threshold at ring electrode captured at 0.5 milliseconds (ms) at 3-month visit.|||volts||Standard Deviation|Mean
1277945|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Social Function|Primary caregiver-reported (through structured interview) child capabilities for 65 items of functional skills grouped under social function. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-65 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277946|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Mobility|Primary caregiver-reported (through structured interview) child capabilities for 59 items of functional skills grouped under mobility. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-59 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277947|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Self-care|Primary caregiver-reported (through structured interview) child capabilities for 73 items of functional skills grouped under self-care. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-73 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277948|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension E|Total percent score on 24 items of GMFM grouped into Dimension E) walking, running, and jumping. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension E determined by dividing score obtained by maximum possible score for that dimension (72), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. E) walking, running, and jumping: (score achieved/72)x 100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277949|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension D|Total percent score on 13 items of GMFM grouped into Dimension D) standing. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension D determined by dividing score obtained by maximum possible score for that dimension (39), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. D) standing: (score achieved/51)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277950|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension C|Total percent score on 14 items of GMFM grouped into Dimension C) crawling and kneeling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension C determined by dividing score obtained by maximum possible score for that dimension (42), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. C) crawling and kneeling: (score achieved/42)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277951|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension B|Total percent score on 20 items of GMFM grouped into Dimension B) sitting. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension B determined by dividing score obtained by maximum possible score for that dimension (60), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. B) sitting: (score achieved/60)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277964|NCT00289991|Secondary|Success at Day 100: Percent of Responders (Randomization Strata)|Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of >14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).|Day 100 (Visit 7)|MITT; data from 1 site excluded due to GCP deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.|||percent of participants|||Number
1277952|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension A|Total percent score on 17 items of GMFM grouped into Dimension A) lying and rolling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension A determined by dividing score obtained by maximum possible score for that dimension (51), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. A) lying and rolling: (score achieved/51)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277953|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure 66-Item Subscale Score (GMFM-66).|GMFM-66: total percent score on 66-item subscale of GMFM-88: Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score determined by dividing score obtained by maximum possible score for the 66 items, and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. GMFM-66: [(total score on subset of 66 items/198)x100].|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277954|NCT00290186|Primary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Total Score (GMFM-88).|"GMFM-88: total percent score on 88 items (I) of motor function grouped into 5 dimensions: A) lying and rolling (17 I), B) sitting (20 I), C) crawling and kneeling (14 I), D) standing (13 I), E) walking, running, jumping (24 I). Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Scores in each dimension determined by dividing score obtained by maximum possible score for that dimension, and multiplying by 100. Range is 0-100% for each: the higher the percent score, the greater the functional ability.~Dimension scores and total GMFM-88 score calculated as:~A) lying and rolling: (score achieved/51)x100 B) sitting: (score achieved/60)x100 C) crawling and kneeling: (score achieved/42)x100 D) standing: (score achieved/39)x100 E) walking, running, and jumping: (score achieved/72)x 100 GMFM-88 = (%A+%B+%C+%D+%E)/number of dimensions GMFM-66: [(total score on subset of 66 items/198)x100]"|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
1277955|NCT00290147|Secondary|Anti-dengue Antibody and T-cell and B-cell Responders|Number of participants who responded, are reported. Response or a positive ELISPOT assay was defined as >65 spot forming cells per million PBMC for T-cells and >20 spot forming cells per million PBMC for B-cells|12 months||||Participants|||Count of Participants
1277956|NCT00290147|Primary|Systemic and Local Reactogenicity Rates for Ungraded Symptoms|Summary of ungraded systemic and local reactogenicity symptoms following each vaccination|Months 0, 1 and 5||||Participants|||Count of Participants
1277957|NCT00289991|Secondary|Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment|Percent of subjects who used other systemic antifungal agents as empirical or therapeutic treatment, defined as either empirical: subject took a systemic antifungal agent at any time after the day of first dose of medication and did not develop a breakthrough proven or probable IFI during the study or therapeutic: subject developed a breakthrough proven or probable IFI.|Day 1 up to Day 180|MITT; data from 1 site excluded due to GCP deviations. Subjects who developed a breakthrough proven or probable IFI were identified only from the study database, not the EORTC/MSG worksheet. In addition, all agents identified to be antifungals were considered to be systemic.|||percent of participants|||Number
1277958|NCT00289991|Secondary|Duration of Treatment|Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.|Day 1 up to Day 180|MITT; data from 1 site excluded due to GCP deviations.|||days||Full Range|Median
1277959|NCT00289991|Secondary|Survival: Percent of Subjects Who Died Within 1 Year|Percent of subjects who died within 1 year after transplant, derived from the crude death rate. All subjects in the MITT population included in this proportion. Only deaths up until and including 365 days after first dose of study medication included in the analysis.|Day 1 up to 1 year (Day 365)|MITT; data from 1 site excluded due to GCP deviations. Typically, subjects received first dose study treatment on the day of their transplant; however, some subjects started treatment up to 48 hours after transplant. Data summarized with first day of study medication defined as Day 1.|||percent of participants|||Number
1277960|NCT00289991|Secondary|Time to Discontinuation of Study Treatment|Time in days to discontinuation of study treatment defined as the number of days from first dose to last dose inclusive as recorded in the dosing log.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations.|||days||95% Confidence Interval|Mean
1277961|NCT00289991|Secondary|Survival: Percent of Subjects Who Died at or Before Day 180|Percent of subjects who died at or before Day 180, derived from the crude death rate. All subjects in the MITT population included in this proportion.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis does not include any deaths recorded in the long-term follow-up data (not available at time of analysis).|||percent of participants|||Number
1277962|NCT00289991|Secondary|Percent of Subjects With Occurrence of Breakthrough IFI|Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.|Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on EORTC/MSG worksheets (not on Case Report Forms or in the database).|||percent of participants|||Number
1278004|NCT00289874|Secondary|"Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period"|Percent change from baseline in average daily β-agonist use over the 3-week treatment period|Baseline and Week 3|The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).|||Percent Change||Standard Deviation|Median
1277965|NCT00289991|Primary|Success at Day 180: Percent of Responders (Randomization Strata)|Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).|Day 180 (Visit 9)|Modified Intent to Treat (MITT): primary analysis population; all randomized subjects: received at least 1 dose of randomized study drug and had allogeneic HSCT; data from 1 site excluded due to Good Clinical Practice (GCP) deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.|||percent of participants|||Number
1277966|NCT00289978|Secondary|Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline|The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Baseline to end of study (Month 24)|Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.|||T2 lesions|Participants|Standard Deviation|Mean
1277967|NCT00289978|Secondary|Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.|Baseline to end of study (Month 24)|Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1277968|NCT00289978|Primary|Estimated Annualized Aggregate Relapse Rate (ARR)|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.|Baseline to end of study (Month 24)|This analysis was conducted using the Intent-to-treat (ITT) population which includes all patients who were randomized and received at least one dose of study drug.|||Relapses per year||95% Confidence Interval|Number
1277969|NCT00289913|Primary|Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™|"GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™.~IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL.~IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL.~IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL."|4 weeks postvaccination with Infanrix™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.|||ELISA units per mL (ELU/mL)||95% Confidence Interval|Geometric Mean
1277970|NCT00289913|Primary|Number of Participants With Adverse Events (AE)|"Systemic and injection site AEs were collected from participants receiving~VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)~VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)~VAQTA™ administered alone (Stage II)~Safety data was collected on a standardized Vaccination Report Card (VRC)~following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE."|Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs|Participants administered at least one dose of vaccine, for whom follow-up was available.|||Participants|||Number
1277971|NCT00289913|Primary|Antibody Response Rate to Haemophilus Influenzae Type b (Hib)|"Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL.~The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™."|4 weeks postvaccination with PedvaxHIB™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1277972|NCT00289913|Primary|Seropositivity Rate (SPR) to Hepatitis A|SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).|4 weeks after dose 2 of VAQTA™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1278005|NCT00289874|Primary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3|Percent change from baseline in FEV1, a measure of airway function, at Week 3|Baseline and week 3|The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).|||Percent Change||95% Confidence Interval|Least Squares Mean
1277973|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277974|NCT00289900|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277975|NCT00289900|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277976|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277977|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277978|NCT00289900|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277979|NCT00289900|Secondary|Percentage of Participants With New Diagnosis of Diabetes|Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and did not have diabetes at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277990|NCT00289900|Secondary|Percentage Change From Baseline in Total Cholesterol (TC)|Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
1277980|NCT00289900|Secondary|Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose|Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became ‘impaired’ during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and normal glycemic status at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277981|NCT00289900|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277982|NCT00289900|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms|Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277983|NCT00289900|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277984|NCT00289900|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277985|NCT00289900|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277986|NCT00289900|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
1277987|NCT00289900|Secondary|Percentage Change From Baseline in TC/HDL-C Ratio|Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
1277988|NCT00289900|Secondary|Percentage Change From Baseline in C-reactive Protein (CRP)|Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Median
1277989|NCT00289900|Secondary|Percentage Change From Baseline in Lipoprotein (a) (Lp[a])|Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Median
1278181|NCT00289276|Secondary|Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF|Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.|3 days pre-admission and 3 days post-discharge|All subjects with at least one heart failure hospitalization and with impedance data pre and post-hospitalization.|||Ohms||Full Range|Mean
1277992|NCT00289900|Secondary|Percentage Change From Baseline in Apolipoprotein (Apo) B|Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
1277993|NCT00289900|Secondary|Percentage Change From Baseline in LDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
1277994|NCT00289900|Secondary|Percentage Change From Baseline in Non-HDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
1277995|NCT00289900|Secondary|Percentage Change From Baseline in Triglycerides (TG)|Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Median
1277996|NCT00289900|Secondary|Percentage Change From Baseline in HDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
1277997|NCT00289900|Primary|Percentage Change From Baseline in the LDL-C/HDL-C Ratio|Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1277998|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
1277999|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
1278000|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
1278001|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
1278002|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
1278003|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
1278006|NCT00289848|Secondary|Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1278007|NCT00289848|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18|Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1278008|NCT00289848|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18|A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.|||Percent||95% Confidence Interval|Least Squares Mean
1278009|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278010|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278011|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits|Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278012|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278013|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.|Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
1278014|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
1278015|NCT00289783|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278016|NCT00289783|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
1278017|NCT00289783|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278018|NCT00289783|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
1278019|NCT00289783|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278020|NCT00289783|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
1278021|NCT00289783|Secondary|Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination|Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.|Within 43 days (Day 0 through Day 42) after vaccination|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278022|NCT00289783|Secondary|Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)|Increased circumferential swelling defined as either swelling with a diameter of >50 mm or a >50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).|Within 4 days (Day 0 to Day 3) after fourth dose vaccination|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278023|NCT00289783|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Day 0-30) following the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278024|NCT00289783|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Day 0-30) following the primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
1278025|NCT00289783|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C|Within the 4 days (Day 0-3) post-vaccination period following the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278026|NCT00289783|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.|Within the 4 days (Day 0-3) following each dose of the primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
1278027|NCT00289783|Secondary|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).|In the 4-day (Day0-3) follow-up period after the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
1278028|NCT00289783|Secondary|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).|In the 4-day (Day 0-3) follow-up period after primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
1278029|NCT00289783|Secondary|Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40|"anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based."|Prior to the fourth dose vaccination and one month after the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278030|NCT00289783|Secondary|Anti-varicella Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010|||Titers||95% Confidence Interval|Geometric Mean
1278031|NCT00289783|Secondary|Number of Subjects With Anti-varicella Titer Equal to or Above 1:40|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010|||Participants|||Count of Participants
1278032|NCT00289783|Secondary|Anti-rubella Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010|||IU/mL||95% Confidence Interval|Geometric Mean
1278033|NCT00289783|Secondary|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010|||Participants|||Count of Participants
1278034|NCT00289783|Secondary|Anti-mumps Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Titers||95% Confidence Interval|Geometric Mean
1278035|NCT00289783|Secondary|Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values|"Anti-mumps antibody cut-off values assessed were >=28 estimated dose 50 (ED50) and >=51 ED50.~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
1278036|NCT00289783|Secondary|Anti-measles Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278037|NCT00289783|Secondary|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
1278038|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278039|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1278040|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278066|NCT00289783|Secondary|Anti-D and Anti-T Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
1278041|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1278042|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278043|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|"hSBA-MenC and hSBA-MenY antibody cut-off values assessed were >=1:4 and >=1:8.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria ) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose|||Participants|||Count of Participants
1278044|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course and prior to the fourth dose vaccination|The Fourth dose ATP cohort for safety included eligible subjects, who met inclusion criteria, who received 3 vaccine doses in the primary vaccination course, who received the fourth vaccine dose, who did not receive a vaccine not specified or forbidden and who were not excluded from from the Primary ATP cohort for immunogenicity.|||µg/mL||95% Confidence Interval|Geometric Mean
1278045|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value|"Anti-PRP antibody cut-off values assessed were >=0.15 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose.|||Participants|||Count of Participants
1278046|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1278047|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibodies Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1278048|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278097|NCT00289757|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).~The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging."|At Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278049|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278050|NCT00289783|Secondary|hSBA-MenC and hSBA-MenY Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1278051|NCT00289783|Secondary|hSBA-MenC and hSBA-MenY Antibody Titers|"Titres are expressed as Geometric Mean Titers (GMTs).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1278052|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|"hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278053|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|"hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278054|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1278055|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1278056|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278160|NCT00289536|Primary|Initial Recovery|Percent increase in factor VIII concentration per dose from pre- to post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU/dL per IU/kg||Full Range|Median
1278057|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278058|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1278059|NCT00289783|Secondary|Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278060|NCT00289783|Secondary|Anti-poliovirus Types 1, 2 and 3 Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1278061|NCT00289783|Secondary|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278062|NCT00289783|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1278063|NCT00289783|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278064|NCT00289783|Secondary|Anti-HBS Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL)~Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278065|NCT00289783|Secondary|Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)|"Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278067|NCT00289783|Secondary|Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278068|NCT00289783|Primary|Number of Subjects With Anti-varicella Titer Equal to or Above 1:5|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5.~Co-administration with Varivax vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
1278069|NCT00289783|Primary|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL.~Co-administration with MMR-II vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
1278070|NCT00289783|Primary|Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50~Co-administration with MMR-II vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
1278071|NCT00289783|Primary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278072|NCT00289783|Primary|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~Co-administration with MMR-II vaccine"|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
1278073|NCT00289783|Primary|Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278074|NCT00289783|Primary|Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
1278075|NCT00289783|Primary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
1278076|NCT00289783|Primary|hSBA-MenY Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1278077|NCT00289783|Primary|hSBA-MenC Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1278078|NCT00289783|Primary|Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|"Titers are expressen as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1278079|NCT00289783|Primary|Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|"Titers were expressed as Geometric Mean Titers (GMTs)~This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1278080|NCT00289783|Primary|Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1278081|NCT00289770|Primary|Number of Subjects With Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|up to Year 11, 12, 13, 14, 15|Analysis was performed on the long-term (LT) Total Vaccinated Cohort, this included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling time-point and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
1278082|NCT00289770|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|During the 30-day follow-up period after additional Engerix vaccination|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
1278083|NCT00289770|Primary|Number of Subjects With Unsolicited Symptoms|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day follow-up period after additional Engerix vaccination|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
1278084|NCT00289770|Primary|Number of Subjects With Solicited Local and General Symptoms Assessed|Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, fever, gastrointestinal, headache.|During the 4-day follow-up period after additional vaccination with Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
1278085|NCT00289770|Primary|Number of Subjects, Receiving an Additional Vaccination of Engerix, With an Anamnestic Response|"Anamnestic response was assessed in subjects receiving an additional vaccine dose of Engerix. Two subjects were found eligible at Year 11 for this additional vaccine dose.~Anamnestic response was defined as:~post-additional vaccination anti-HBs concentration >= 10 mIU/mL in subject seronegative before additional dose.~4-fold increase post-additional dose compared to pre-additional vaccine time point."|30 days post additional dose of Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
1278086|NCT00289770|Primary|Anti-HBs Antibody Concentrations|"Subjects who lost seroprotective concentrations for anti-HBs (< 10 mIU/mL) at any of the LT follow-up timepoints received an additional dose of Engerix after year 15.~Two subjects were eligible for this after Year 11.~3.29 in the table means a concentration of < 3.3 mIU/mL.~As the concentration was calculated per subject no mean concentration was calculated and also no measure of dispersion."|at Year 11, pre-additional vaccine, after additional dose of Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||mIU/mL|||Number
1278161|NCT00289471|Primary|Performance Characteristics|Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment|Cross-sectional [at baseline; no longitudinal component]||||Percentage of participants||95% Confidence Interval|Number
1278087|NCT00289770|Primary|Anti-HAV and Anti-HBs Antibody Concentrations|"Concentrations are expressed as geometric mean concentrations (GMCs) in mIU/mL.~The laboratory assay was changed from Year 13 to Year 14 to in-house ELISA and at Year 15 to CLIA for anti-HBs GMCs.Thus for the sake of bridging, blood samples corresponding to Year 14 previously tested with ELISA were re-tested with CLIA (Year 14*)."|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278088|NCT00289770|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values were defined 3.3 mIU/mL for the in-house anti-HBs assay and 6.2 mIU/mL for the ChemiLuminescence ImmunoAssay, which was also considered as seropositivity, and 10 mIU/mL.|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.|||Participants|||Count of Participants
1278089|NCT00289770|Primary|Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value|Cut-off value was defined as 15 milli-international units per milliliter (mIU/mL). This was considered as seropositivity.|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.|||Participants|||Count of Participants
1278090|NCT00289757|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the follow-up period after additional vaccination up to Year 20|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subjects|||Number
1278091|NCT00289757|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Grade AE = produced significant impairment of functioning or incapacitation and was a definite hazard to the subject's health.~Related AE = assessed by the investigator as related to the study vaccination."|During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15)|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subjects|||Number
1278092|NCT00289757|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed included fatigue, fever, gastrointestinal symptoms, and headache.|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subjects|||Number
1278093|NCT00289757|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain = symptom that prevented normal activities. Grade 3 redness and swelling = redness or swelling above 30 mm and persisting more than 24 hours.~Any = incidence of a particular symptom regardless of intensity."|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subjects|||Number
1278094|NCT00289757|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination|Analysis was performed on the Long Term Total cohort which included all subjects who returned to the follow-up study and who had received at least 1 dose of the vaccine in the primary study.|||Subjects|||Number
1278095|NCT00289757|Primary|Number of Seropositive Subjects for Anti-HAV Antibodies.|"Seropositivity for anti-HAV antibodies defined as antibody concentrations ≥ 15 mIU/mL for Year 11 to Year 20 time points.~The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging."|From Year 11 to Year 20|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint.|||Subjects|||Number
1278096|NCT00289757|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL.|Before the additional dose, 14 days and 30 days after the additional dose|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||mIU/mL|||Number
1278162|NCT00289458|Primary|Change in Dual Task Function|change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)|baseline and 11 weeks||||unit of scale (seconds)||Standard Deviation|Mean
1278163|NCT00289458|Secondary|Change in Physical Activity|change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)|baseline and 11 weeks||||unit of scale||Standard Deviation|Mean
1278098|NCT00289744|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 30-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.|||Participants|||Count of Participants
1278099|NCT00289744|Primary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.|||Participants|||Count of Participants
1278100|NCT00289744|Primary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.|During the 4-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.|||Participants|||Count of Participants
1278101|NCT00289744|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy|Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|At Year 6, 7, 8, 9 and 10|The analysis was performed on the long-term (LT) total vaccinated cohort.|||Participants|||Count of Participants
1278102|NCT00289744|Primary|Number of Subjects With Immune Response to the Additional Dose of Engerix™-B|"Immune response was defined as:~anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points~at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points."|One month after the additional dose administration|The analysis was performed on the total vaccinated cohort for the additional dose.|||Participants|||Count of Participants
1278103|NCT00289744|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration||Before and 1 month after the additional dose administration|The analysis was performed on the total vaccinated cohort for the additional dose.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1278104|NCT00289744|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration||At Year 6, 7, 8, 9 and 10|The analysis was performed on the long-term (LT) according to protocol (ATP) cohort for immunogenicity.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1278105|NCT00289744|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration||Years 6, 7, 8, 9, and 10.|The analysis was performed on the long-term (LT) according to protocol (ATP) cohort for immunogenicity.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1278106|NCT00289731|Secondary|Number of Subjects With SAEs|"SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination."|At Month 12 (M12), Month 24 (M24) and Month 36 (M36)|The analysis was performed on the Long Term Total Vaccinated Cohort, which included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the current blood sample time point at one, two and three years (Month 12, 24, 36) after first vaccination.|||Participants|||Count of Participants
1278107|NCT00289731|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination."|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1278108|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).|At Month 12 (M12), Month 24 (M24) and Month 36 (M36)|The analysis was performed on the LT ATP cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278109|NCT00289731|Secondary|Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).|At Month 12 (M12), Month 24 (M24) and Month 36 (M36)|The analysis was performed on the LT ATP cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.|||Participants|||Count of Participants
1278110|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).|At Month 12 (M12), Month 24 (M24) and Month 36 (M36)|The analysis was performed Long Term According-To-Protocol (LT ATP) cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.|||Participants|||Count of Participants
1278111|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition|"Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.~The antibody concentrations were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278112|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication|"Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.~The antibody concentrations were stratified by concomitant medication (concomitant medication and no concomitant medication)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278113|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption|"Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.~The antibody concentrations were stratified by alcohol consumption as follows: none or mild, moderate and heavy."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278114|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status|"Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.~The antibody concentrations were stratified by smoking status (smokers and non-smokers)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278115|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by BMI|"Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.~The antibody concentrations were stratified by BMI as follows: healthy, overweight and obese."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278116|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Age|"Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.~The antibody concentrations were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278117|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Gender|"Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.~The antibody concentrations were stratified by gender (females and males)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278118|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition|"A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.~The seroprotection rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278119|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication|"A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.~The seroprotection rates were stratified by concomitant medication (concomitant medication and no concomitant medication)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278120|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption|"A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.~The seroprotection rates were stratified by alcohol consumption as follows: none or mild, moderate and heavy."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278164|NCT00289458|Primary|Change in Falls-Efficacy|change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)|baseline and 11 weeks|ITT and LOCF|||unit of scale||Standard Deviation|Mean
1278121|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status|"A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.~The seroprotection rates were stratified by smoking status (smokers and non-smokers)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278122|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by BMI|"A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.~The seroprotection rates were stratified by BMI as follows: healthy, overweight and obese."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278123|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Age|"A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.~The seroprotection rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278124|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Gender|"A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.~The seroprotection rates were stratified by gender (females and males)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278125|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition|"Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.~The seropositivity rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278126|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication|"Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.~The seropositivity rates were stratified by concomitant medication (concomitant medication and no concomitant medication)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278127|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption|"Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.~The seropositivity rates were stratified by alcohol consumption as follows: None or Mild, Moderate and Heavy."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278128|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status|"Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.~The seropositivity rates were stratified by smoking status (smokers and non-smokers)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278129|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)|"Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.~The seropositivity rates were stratified by BMI as follows: healthy, overweight and obese."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278130|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age|"Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.~The seropositivity rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278131|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender|"Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.~The seropositivity rates were stratified by gender (females and males)."|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278165|NCT00289458|Primary|Change in Walking|change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks|baseline and 11 weeks|ITT and LOCF|||unit of scale (meters per 6 minutes)||Standard Deviation|Mean
1278132|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278133|NCT00289731|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278134|NCT00289731|Primary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration ≥ 15mIU/mL; seropositivity for anti-HBs antibodies was defined as anti-HBs antibody concentration ≥ 3.3 mIU/mL.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1278135|NCT00289731|Primary|Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.|At Month 7 after Twinrix vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1278136|NCT00289718|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the LT Total Cohort that included all subjects who returned at a specified follow-up study and who belonged to the Total Cohort of the primary vaccination course.|||Subjects|||Number
1278137|NCT00289718|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||subjects|||Number
1278138|NCT00289718|Primary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed included fatigue, headache, malaise, nausea, vomiting and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination.|During the 4-day (Day 0-3) follow-up period after additional HBV vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||Subjects|||Number
1278139|NCT00289718|Primary|Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL. If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|Before the additional dose and 1 month after the additional dose|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||mIU/mL|||Number
1278140|NCT00289718|Primary|Number of Subjects Reporting Serious Adverse Events (SAE)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the follow-up period after additional vaccination (minimum 30 days)|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||subjects|||Number
1278141|NCT00289718|Primary|Number of Subjects Seroprotected for Anti-HBs Antibodies.|"A seroprotected subject was defined as a subjects with the anti-HBs titres ≥ 10 mIU/mL.~NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)"|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||Subjects|||Number
1278142|NCT00289718|Primary|Number of Subjects Seropositive for Anti-HB Antibodies|"A seropositive subject was defined as a vaccinated subject who had anti-HB antibody titres ≥ 1 mIU/mL.~NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)"|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||Subjects|||Number
1278166|NCT00289458|Primary|Change in Chair Stands|change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)|baseline and 11 weeks|ITT and LOCF|||number of stands per 30 seconds||Standard Deviation|Mean
1278167|NCT00289458|Primary|Change in Balance|Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)|baseline and 11 weeks|ITT and LOCF|||units on a scale||Standard Deviation|Mean
1278143|NCT00289718|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA). From Year 11 to Year 14, anti-HBs antibody concentrations were tested with ELISA with cut-off of 3.3 mIU/mL while, Year 14* onwards, anti-HBs antibody concentrations were tested with the CLIA with cut-off of 6.2 mIU/mL.|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||mIU/mL||95% Confidence Interval|Geometric Mean
1278144|NCT00289718|Primary|Number of Subjects Seropositive for Anti-HAV Antibodies|A seropositive subject was defined as a vaccinated subject who had a anti-HAV antibody titres ≥ 33 mIU/ml.|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||Subjects|||Number
1278145|NCT00289718|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed include pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Day 0-3) follow-up period after additional HBV vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||subjects|||Number
1278146|NCT00289718|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||mIU/mL||95% Confidence Interval|Geometric Mean
1278147|NCT00289653|Secondary|Smoking Cessation|self reported # cigarettes per day|Week 10||||cigarettes per day||Standard Deviation|Mean
1278148|NCT00289653|Primary|Carbon Monoxide Levels|Expired Co levels were measured to confirm smoking status|measured at week 10||||parts per million||Standard Deviation|Mean
1278149|NCT00289536|Secondary|Pre-infusion Von Willebrand Factor Antigen (VWF:Ag)|Percentage of VWF:Ag. Relationships between baseline VWF:Ag and pharmacokinetic parameters (initial recovery, total AUC/dose, and half-life) were evaluated statistically.|At baseline and before each pharmacokinetic evaluation|Intent to treat: participants who received at least 1 of the 3 infusions of rAHF-PFM and had pharmacokinetic evaluation(s).|||U/dL||Full Range|Median
1278150|NCT00289536|Secondary|Pre-infusion Von Willebrand Factor Ristocetin Cofactor Activity (VWF:Rco)|Percentage of normal VWF:Rco activity. Normal is a lab standard consisting of a non-hemophilic population. Relationships between baseline VWF:Rco and pharmacokinetic parameters (initial recovery, total AUC/dose, and half-life) were evaluated statistically.|At baseline and before each pharmacokinetic evaluation|Intent to treat: participants who received at least 1 of the 3 infusions of rAHF-PFM and had pharmacokinetic evaluation(s)|||Percent of normal VWF:Rco activity||Full Range|Median
1278151|NCT00289536|Secondary|Maximum Plasma Concentration|Maximal factor VIII concentration after infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU/dL||Full Range|Median
1278152|NCT00289536|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted CL * Mean Residence Time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||dL/kg||Full Range|Median
1278153|NCT00289536|Secondary|Mean Residence Time|Computed as total AUMC divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||hour||Full Range|Median
1278154|NCT00289536|Secondary|Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||mL/kg*hour||Full Range|Median
1278155|NCT00289536|Secondary|Total Area Under the Moment Curve|Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU*hour^2/dL||Full Range|Median
1278156|NCT00289536|Secondary|Total Area Under the Curve|Total AUC with extrapolation using the slope of the β-phase|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU*hour/dL||Full Range|Median
1278157|NCT00289536|Secondary|Area Under the Curve|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU*hour/dL||Full Range|Median
1278158|NCT00289536|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||hour||Full Range|Median
1278159|NCT00289536|Secondary|Area Under the Curve/Dose|Area under the plasma factor VIII concentration versus time curve (AUC) estimated by linear trapezoidal method per dose.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU*hour/dL per IU/kg||Full Range|Median
1278168|NCT00289341|Secondary|Change in PSA Slope, Pre- vs Post-vaccination.|To model the evolution of PSA (in log-scale) during the three study phases (pre-vaccine, vaccine, and post-vaccine phases), a mixed linear spline model was used. Two knots (one at the start of the vaccine phase and the other at the start of the post-vaccine phase) were used to directly quantify the differences in slopes between each phase. To account for the heterogeneous treatment effect and the repeated measures structure, random effects are incorporated into the model. For the general model, random effects for the intercept, slope and the first knot were considered.|pre- vs post- vaccination PSA slopes.|23 of 24 patients were analyzed. 1 patient was not evaluable.|||log₂(ng/ml)/month||95% Confidence Interval|Number
1278169|NCT00289341|Primary|"Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The Number Indicated is the Median Difference of Post-Pre, of Each Antigen Group."|The difference between post minus pre-vaccination bulk T cell proliferation was calculated for each antigen.|pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13|The Arm/Group Title is different for this outcome. In the 1st outcome analysis, AEs were being compared between placebo and tx groups. After the blinded phase, placebo pts crossover and we compare pre-vs post vaccination T cell proliferation in all pts. 22 of 24 pts'assays were analyzed. Two were excluded as they failed internal controls.|||cells *10^3 per minute||95% Confidence Interval|Median
1278170|NCT00289341|Primary|Adverse Event|Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.|End of blinded phase (wk 9)|All AEs occurring 5 or more times during the study were analyzed. All AEs reported are grade 1 except as noted.|||Adverse Events|||Number
1278171|NCT00289315|Primary|BMI Z-score (Girls)|Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean|Baseline and three years|primary preventions, primary + secondary prevention, control group (girls)|||z score||Standard Error|Mean
1278172|NCT00289315|Primary|% Body Fat (Girls)|change in percent body fat between Baseline and 3 years for girls|Baseline and 3 years|children in primary prevention, primary + secondary prevention, and control group (girls)|||percentage of body fat||Standard Error|Mean
1278173|NCT00289315|Primary|BMI Z-score (Boys)|Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean|Baseline and three years|primary preventions, primary + secondary prevention, control group (boys)|||z score||Standard Error|Mean
1278174|NCT00289315|Primary|% Body Fat (Boys)|change in percent body fat between Baseline and 3 years for boys|Baseline and 3 years|children in primary prevention, primary + secondary prevention, and control group (boys)|||percentage of body fat||Standard Error|Mean
1278175|NCT00289289|Secondary|Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden|AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day.|6 months (per Intervention)|Of the 256 randomized to ON-OFF or OFF-ON programming, 225 had device data necessary for computing AT/AF burden in both randomized study periods.|||hours per day||Standard Deviation|Mean
1278176|NCT00289289|Secondary|Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)|The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF.|6 months (per Intervention)|All randomized subjects with follow-up during intervention pacing feature programming period.|||Months||Standard Deviation|Mean
1278177|NCT00289289|Secondary|Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist|The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed.|6 months (per Intervention)|Of the 256 randomized subjects only 211 completed the AF symptom checklist at both the 9-month and 15-month visit. Since this was a crossover study, data from both visits was required for the subject to be included in the analysis|||Scores on a scale||Full Range|Median
1278178|NCT00289289|Primary|Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month|The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed|6-months (per Intervention)|Patient Assistant data which contained markers for symptomatic atrial tachycardia or atrial fibrillation episodes obtained from save-to-disk data was required from both randomized follow-up periods (3-9 months and 9-15 months) for the subject to be included in the primary ITT analysis.|||Episodes per subject per month||Standard Deviation|Mean
1278182|NCT00289276|Primary|Number of Subjects With at Least 30 Days of Daily Impedance Measurements|Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.|Up to 36 months.|Includes all enrolled participants.|||participants|||Number
1278184|NCT00289211|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH)."|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.|||percent of functional C1INH||Standard Deviation|Mean
1278185|NCT00289211|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.|||mg/dL||Standard Deviation|Mean
1278186|NCT00289211|Secondary|Time to Complete Resolution of the HAE Attack|Randomized subjects were contacted 72-96 hours (3-4 days) after discharge from the study site to determine when complete resolution of the HAE attack occurred.|72 hours|ITT Population.|||hours||95% Confidence Interval|Median
1278187|NCT00289211|Secondary|Number of Subjects With Beginning of Substantial Relief of the Defining Symptom|Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|ITT-Efficacy (ITT-E) Population (N=68; 3 of the 71 randomized [ie, ITT] subjects were excluded from the ITT-E Population, as it was later determined that they did not experience a definitive hereditary angioedema [HAE] attack).|||participants|||Number
1278188|NCT00289211|Primary|Time to Beginning of Substantial Relief of the Defining Symptom|Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|Intent-to-treat (ITT) Population (all randomized subjects). Since less than 50% of subjects in the placebo group achieved the endpoint, median time to event was not estimable (NE). Further, the number of censored events in the C1INH-nf and placebo groups precluded estimation of the 95% confidence interval (CI) upper bound for median time to event.|||hours||95% Confidence Interval|Median
1278189|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period|The PNIF score is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PM PNIF measurements was completed and recorded after assessment of allergy symptoms in the PM (12 hours after study medication). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Baseline PM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the 4 consecutive days prior to randomization. Change from baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Liters per minute||Standard Error|Least Squares Mean
1278190|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period|PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. AM PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication). Three measurements were taken and the highest measurement recorded on the electronic diary. Baseline AM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Liters per minute||Standard Error|Least Squares Mean
1278191|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period|PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication), and 12 hours later in the PM (after recording allergy symptoms). Three measurements were taken and the highest measurement recorded on the electronic diary. Daily PNIF is defined as average of PM PNIF and AM PNIF of the next day prior to AM dosing. The Baseline is defined as average of the last 8 readings (4 AM and 4 PM) of PNIF measurement over the four 24-hour periods prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Liters per minute||Standard Error|Least Squares Mean
1278192|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period|IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The PM rIOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278239|NCT00289133|Secondary|American Knee Society Evaluation - Total Score|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 year|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||scores on a scale|Knees|Standard Deviation|Mean
1278193|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period|rIOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM rIOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278194|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period|IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM pre-dose iIOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iIOSS is defined as the average of the non-missing values for iIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278195|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period|Individual ocular symptom scores (IOSS) for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The IOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily IOSS is defined as average of the PM IOSS and the AM IOSS of the next day prior to AM dosing. The BL daily IOSS is defined as the average of the daily IOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily IOSS minus BL daily IOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278196|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period|The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The PM rTOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278197|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period|The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates more severe symptoms. The AM rTOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Deviation|Mean
1278198|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period|The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The AM pre-dose iTOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTOSS is defined as the average of the non-missing values for iTOSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278199|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period|TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The rTOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily rTOSS is defined as average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The BL daily rTOSS is defined as the average of the daily rTOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTOSS minus BL daily rTOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Deviation|Mean
1278200|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period|rINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The PM rINSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population|||Scores on a scale||Standard Error|Least Squares Mean
1278201|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment|INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278202|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period|The iINSS score for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278203|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period|The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The Baseline daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily INSS minus Baseline daily INSS. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Only those participants available at the time of assessment were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1278204|NCT00289198|Secondary|Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those participants available at the specified time points were analyzed. Change from Baseline is the value at indicated time-point minus the baseline value*100.|Baseline and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Percent change||Standard Error|Least Squares Mean
1278205|NCT00289198|Secondary|Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Percent change||Standard Error|Least Squares Mean
1278224|NCT00289185|Primary|Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|The seroprotection cut-off value was 10 milli-international units per milliliter (mIU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subject|||Number
1278206|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278207|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278208|NCT00289198|Secondary|Number of Participants With Response to Therapy Over Entire Treatment Period|Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country. Effectiveness of the study drug for relieving allergic rhinitis symptoms over the entire treatment period was compared with Placebo.|Up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Participants|||Number
1278209|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period|The AM pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each individual symptom score ranged on a scale of 0 to 3 where 0 indicated healthy condition and 3 indicated severity of the symptoms. The total score ranged on a scale of 0 to 12 where 0 indicated healthy condition and 12 indicated worst condition of symptoms. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to Week 6|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278210|NCT00289198|Primary|Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed|Baseline (Day 1) and up to Week 6|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1278211|NCT00289185|Secondary|Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia|The parasite density in subjects prevalent for P. falciparum parasitemia (Subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 7 months after administration of Dose 3 of RTS,S or HBV vaccine (Month 9). Parasite density is expressed as mean, minimum and maximum density in parasite per µL. This outcome for solely assessed in the Engerix-B Group, as no subject in the RTS,S/AS02D was assessed as prevalent for parasitemia.|At Month 9|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.|||Parasite per microliter (µL)||Full Range|Mean
1278212|NCT00289185|Secondary|Number of Subjects Prevalent for Parasitemia|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.|At Month 9|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.|||Subjects|||Number
1278238|NCT00289133|Secondary|American Knee Society Evaluation - Total Score|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||scores on a scale|Knees|Standard Deviation|Mean
1278213|NCT00289185|Secondary|Time to First Malaria Infection|Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.|Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.|||n/PYAR|||Number
1278214|NCT00289185|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study, from Week 0 to Month 20.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1278215|NCT00289185|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days (Days 0–29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1278216|NCT00289185|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability, and loss of appetite. Fever was defined as axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C).|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1278217|NCT00289185|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling following vaccination with the TETRActHib vaccine..|Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1278218|NCT00289185|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling following vaccination with the RTS,S/AS02D or Engerix-B vaccine.|Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1278219|NCT00289185|Secondary|Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of 0.5 EL.U/mL.|Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||ELISA unit per milliliter||95% Confidence Interval|Geometric Mean
1278220|NCT00289185|Primary|Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seropositivity cut-off value was 15 ELISA units per milliliter (EL.U/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subjects|||Number
1278221|NCT00289185|Primary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.15 microgram per milliliter (µg/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subjects|||Number
1278222|NCT00289185|Primary|Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subject|||Number
1278223|NCT00289185|Primary|Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subject|||Number
1278225|NCT00289185|Primary|Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 15 EL.U/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||ELISA unit per millilite||95% Confidence Interval|Geometric Mean
1278226|NCT00289185|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 9 to Month 20.||||Subject|||Number
1278227|NCT00289185|Primary|Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The cut-off of the assay is the seroprotection cut-off value of 0.15 µg/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||international unit per milliliter||95% Confidence Interval|Geometric Mean
1278228|NCT00289185|Primary|Concentrations of Antibodies Against Tetanus (Anti-T)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||international unit per milliliter||95% Confidence Interval|Geometric Mean
1278229|NCT00289185|Primary|Concentrations of Antibodies Against Diphtheria (Anti-D)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||international unit per milliliter||95% Confidence Interval|Geometric Mean
1278230|NCT00289185|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Week 0 to Month 9.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1278231|NCT00289185|Primary|Concentrations of Antibodies Against Hepatitis B (Anti-HB)|Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The cut-off of the assay was the seroprotection cut-off of 10 mIU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||milli-international unit per milliliter||95% Confidence Interval|Geometric Mean
1278232|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.|||percentage of knees|Knees||Number
1278233|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.|||percentage of knees|Knees||Number
1278234|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which the radiographs were analyzed was the number available for analysis at this post-operative timepoint.|||percentage of knees|Knees||Number
1278235|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||percentage of knees|Knees||Number
1278236|NCT00289133|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.|Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||scores (points) on a scale|Knees|Standard Deviation|Mean
1278237|NCT00289133|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.|2 year|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||scores (points) on a scale|Knees|Standard Deviation|Mean
1278240|NCT00289133|Primary|Survivorship (Revision of Any Component for Any Reason)|Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|5 years|Survivorship can only be calculated on knees (not participants as some study subjects had bilateral knees in the study) with post-operative follow-up. 35 knees were excluded due to post-operative follow-up not being available. 67 knees were excluded due to protocol violations.|||percentage of knees|number of knees|95% Confidence Interval|Number
1278241|NCT00289120|Primary|The Plasma and Urine Parameters|"The Urine Parameters that were assessed at the end of cola and water (arms) phase:~Urine Parameters:~uNa (mEq per d) uK (mEq per d)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of Cola and water phase||||mEq per d||Standard Deviation|Mean
1278242|NCT00289120|Secondary|Urinary pH|"The Urine pH that were assessed at the end of cola and water (arms) phase The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase||||pH||Standard Deviation|Mean
1278243|NCT00289120|Secondary|Total Urine Volume|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Urine Parameters:~Total Urine Volume (mL/day)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase||||mL/day||Standard Deviation|Mean
1278244|NCT00289120|Primary|The Plasma Osmolarity|"The Plasma osmolarity that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~OSM (mOsm/L)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of cola and water phase||||mOsm/L||Standard Deviation|Mean
1278245|NCT00289120|Primary|The Plasma and Urine Parameters|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~Na (mEq per L) K (mEq per L) CL (mEq per L) CO2(mEq per L) AG (mEq per L)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of Cola and water phase||||mEq/L||Standard Deviation|Mean
1278246|NCT00289120|Primary|The Plasma and Urine Parameters|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~CA (mg per dL) GLU (mg per dL) BUN (mg per dL) Cr (mg per dL) Prot (mg per dL) ALB (mg per dL)~Urine Parameters:~uCa (mg per dL) uMg (mg per dL) uP (mg per dL) uCr (mg per dL) uCit (mg per dL) uOx (mg per dL) uUA (mg per dL)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase||||mg per dL||Standard Deviation|Mean
1278247|NCT00289107|Secondary|SF-12 Patient Outcomes||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||||||
1278248|NCT00289107|Secondary|Medical Imaging||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||||||
1278249|NCT00289107|Secondary|Revisions||On-going to end of study|||||||
1278250|NCT00289107|Secondary|Complications||On-going to end of study|||||||
1278251|NCT00289107|Primary|Knee Society Score|The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.|Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||Scores on a scale||Standard Deviation|Mean
1278252|NCT00289094|Secondary|SF-12 Patient Outcomes||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||||||
1278253|NCT00289094|Secondary|Medical Imaging||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||||||
1278254|NCT00289094|Secondary|Complications/Revisions||On-going to end of study.|||||||
1278255|NCT00289094|Primary|Knee Society Scores|The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.|Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||Scores on a scale||Standard Deviation|Mean
1278256|NCT00289016|Secondary|Number of Participants With Adverse Events|"The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).~Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes."|From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days.|ITT population|||participants|||Number
1278257|NCT00289016|Secondary|Duration of Response|Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population with an objective response (PR or CR)|||days||Full Range|Median
1278258|NCT00289016|Secondary|Time to Longest Continuous Response|Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant’s last response interval.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population with an objective response (PR or CR)|||days||Full Range|Median
1278259|NCT00289016|Secondary|Time to Progression|"Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease.~Median time to progression was calculated using the Kaplan-Meier method."|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population|||days||Full Range|Median
1278260|NCT00289016|Secondary|Overall Survival|Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days|ITT population|||days||Full Range|Median
1278261|NCT00289016|Primary|Objective Tumor Response Rate|"Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart.~Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:~Complete response (CR): zero tumor burden~Partial response (PR): a 30% or greater decrease in tumor burden~Progressive disease (PD): a 20% or greater increase in tumor burden~Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)"|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days|Intent-to-treat (ITT) population (all participants who received at least 1 dose of talimogene laherparepvec)|||percentage of participants|||Number
1278262|NCT00288912|Secondary|Arthritis Self Efficacy|The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy.|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
1278263|NCT00288912|Secondary|AIMS 2 Affect|The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale (“all days” to “no days”). Scores can range from 0-10, with higher scores indicating worse affect.|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
1278264|NCT00288912|Secondary|AIMS 2 Physical Function|The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale (“all days” to “no days”). Scores can range from 0-10, with higher scores indicating worse function.|Baseline and 12-month follow-up||||units on a scale||Standard Deviation|Mean
1278265|NCT00288912|Primary|Pain|Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale (“all days” to “no days”). The possible range of scores is 0-10, with higher scores indicating more severe pain.|Baseline and 12-month follow-up||||units on a scale||Standard Deviation|Mean
1278266|NCT00288886|Secondary|Rates of Hospitalization (Across the Prior 90 Days)|Number of days hospitalized for any reason per the previous 90 days|Assessed at Baseline, 3-, 6-, and 12-months||||days||Standard Deviation|Mean
1278267|NCT00288886|Secondary|Days of Substance Abuse (Across the Prior 90 Days)||Assessed at Baseline, 3-, 6-, and 12-month follow-up||||percentage of 90 days||Standard Deviation|Mean
1278268|NCT00288886|Secondary|Self-help Support Group Attendance||Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year||||days||Standard Deviation|Mean
1278269|NCT00288886|Secondary|Aftercare Attendance|Measures of aftercare attendance include: Percentage of participants who attended at least 1 aftercare session; percentage of participants who attended at least 2 aftercare sessions/month for at least 3, 6, 9 and 12 months; and percentage of participants who passed the VAMC's SUD continuity of care performance measure (a benchmark for retention of clients in aftercare for at least two visits each month for 3 months following initial treatment)|Assessed at 3-, 6-, 9-, and 12-months||||percentage of participants|||Number
1278270|NCT00288886|Secondary|Days Until First Use of Alcohol or Drugs||Baseline to 12 months||||days||Standard Deviation|Mean
1278271|NCT00288886|Secondary|Abstinence Rate (During the Preceding 90 Days) at 3- and 6-months Follow-up Point as Assessed by the Form-90|Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.|Assessed at 3 and 6 months||||participants|||Number
1278285|NCT00288704|Other Pre-specified|Change From Baseline to Endpoint (Week 6) in Physician's Global Assessment|The Physician's Global Assessment was an evaluation at each visit on a scale of 0=no disease activity to 10=severe disease activity. A negative value in change in Physician's Global Assessment is indicative of an improvement.|Baseline to Week 6 (Part A)||||Units of a Scale||Standard Deviation|Mean
1278272|NCT00288886|Primary|Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90|Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.|Assessed at 12 months||||participants|||Number
1278273|NCT00288860|Primary|Rehospitalization|Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program|12 months post discharge||||participants|||Number
1278274|NCT00288860|Secondary|Depressive Symptoms, Subjective Quality of Life|Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)|12 months post-discharge (8 months post intervention)||||units on a scale||Standard Deviation|Mean
1278275|NCT00288860|Primary|Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms|"Higher scores are worse outcomes on all four measures:~Aggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)"|12 months post-discharge (8 months post intervention)||||Scores on a scale||Standard Deviation|Mean
1278276|NCT00288704|Other Pre-specified|Change From Baseline to Open-Label Extension Week 72 in Number of Disease Flare Days|"OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis.~A Disease flare day was any day where the mean Key Symptom Score (KSS) was greater than 3. The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue)."|From Baseline (Week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.|||Number of Days||Standard Deviation|Mean
1278277|NCT00288704|Other Pre-specified|Change From Baseline to Open-Label Extension Week 72 in Patient's Global Assessment|"The Patient's Global Assessment was a question on the Daily Health Assessment Form Considering all the ways that FCAS/MWS affects you, please rate how you are doing based on the following scale 0=very well to 10=very poor. A negative value in change in Patient's Global Assessment is indicative of an improvement.~OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis."|From Baseline (Week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.|||Units of a Scale||Standard Deviation|Mean
1278278|NCT00288704|Other Pre-specified|Summary of Mean Change From Baseline to Open-Label Extension Week 72 in KSS|"OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis.~The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).~A negative change in mean values indicated improvement in symptoms."|From Baseline (week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.|||Units of a scale||Standard Deviation|Mean
1278279|NCT00288704|Other Pre-specified|Number of Subjects With at Least 75% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Week 6 (Part A)||||Participants|||Number
1278280|NCT00288704|Other Pre-specified|Number of Subjects With at Least 50% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Week 6 (Part A)||||Participants|||Number
1278281|NCT00288704|Other Pre-specified|Number of Subjects With at Least 30% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Endpoint (Week 6)||||Participants|||Number
1278282|NCT00288704|Other Pre-specified|Median Change From Baseline to Week 6 (Part A) Endpoint in Serum Amyloid A (mg/L)|An abnormal value for SAA was considered > 6.4 mg/L.|Baseline to Endpoint of Part A||||Milligrams per Liter||Standard Deviation|Median
1278283|NCT00288704|Other Pre-specified|Median Change From Baseline to Week 6 (Part A) Endpoint in C-Reactive Protein (mg/L)|An abnormal value for CRP was considered > 8.4 mg/L.|Baseline to Endpoint of Part A||||Milligrams per Liter||Standard Deviation|Median
1278284|NCT00288704|Other Pre-specified|Mean Change From Baseline to Endpoint (Week 6) in Patient's Global Assessment|"The Patient's Global Assessment was a question on the Daily Health Assessment Form Considering all the ways that Familial Cold Autoinflmatory Syndrome (FCAS) /Muckle-Wells Syndrome (MWS) affects you, please rate how you are doing based on the following scale 0=very well to 10=very poor. A negative value in change in Patient's Global Assessment is indicative of an improvement."|Baseline to Week 6 (Part A)||||Visual Analog Scale||Standard Deviation|Mean
1278430|NCT00286741|Primary|Systolic Blood Pressure||12 months||||mmHg||Standard Deviation|Mean
1278431|NCT00286741|Secondary|Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES).||one year|||||||
1278286|NCT00288704|Other Pre-specified|Mean Change From Baseline to Endpoint (Week 6) in Number of Disease Flare Days Per Patient|"A Disease flare day was any day where the mean Key Symptom Score (KSS) was greater than 3. The KSS was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was calculated for 21 Day Periods at baseline and at the endpoint (from Weeks 3 - 6). The difference in the number of flares between the two periods was averaged for all subjects.~The DHAF was used because it is a validated instrument to collect subject's self-reported responses. It was the basis for the KSS and the flare day count."|Baseline to Week 6 (Part A)||||Days||Standard Deviation|Mean
1278287|NCT00288704|Primary|Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B)|"The mean Key Symptom Score (KSS --from the validated, patient-administered DHAF) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).~Subjects all received rilonacept 160 mg from week 6 through week 14. At week 15, subjects were re-randomized in a 1:1 ratio between Placebo and rilonacept 160 mg. Subjects baseline period was the 21-day period prior to week 15 randomization.~A positive score indicated a worsening of symptoms versus an active treatment rilonacept baseline period."|Week 15 through Week 24 (randomized withdrawal)|Subjects were re-randomized as part of the randomized withdrawal period (Part B). Subjects were not necessarily assigned the same treatment as in the first double-blind portion (Part A). Subjects were analyzed using last observation carried forward.|||Units of a Scale||Standard Deviation|Mean
1278288|NCT00288704|Primary|Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS)|"The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was averaged over two 21-day daily reporting periods (the 3 weeks prior to both baseline and week 6). In part A, a negative change in mean values indicated improvement under treatment with rilonacept in symptoms.~The DHAF was used because it is a validated instrument to collect subject's self-reported responses."|Baseline (Days -21 to -1) and Week 6 (Days 21-42)|Cryopyrin Associated Autoinflammatory Syndrome (CAPS) is a rare, orphan, hereditary disease. There are several hundred CAPS cases in the United States.|||Units of a Scale||Standard Deviation|Mean
1278289|NCT00288639|Secondary|Subjects Assessment of Optimal Sleep|Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.|Baseline, End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period).|||participants|||Number
1278290|NCT00288639|Secondary|Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline|Count of subjects with a weight gain of at least 7 percent relative to baseline.|Baseline, End of 21-week treatment|"Safety population (all subjects who had taken at least~1 dose of study drug)."|||participants|||Number
1278291|NCT00288639|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.|Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.|Baseline, End of 21-week treatment|"Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). n is the number of subjects contributing to the mean at the specified time point."|||score on scale||95% Confidence Interval|Mean
1278292|NCT00288639|Secondary|Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores|Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 – 1.|Baseline, end of 21-week treatment|"Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). n is the number of subjects contributing to the mean at the specified time point."|||score on scale||95% Confidence Interval|Mean
1278293|NCT00288639|Secondary|Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)|The CGIC is a clinician’s judgment of the overall change in the patient’s condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period).|||partcipants|||Number
1278294|NCT00288639|Secondary|Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)|The PGIC is a patient-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period).|||participants|||Number
1278295|NCT00288639|Secondary|Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency|Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline observation period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) (all subjects who received at least 1 dose of study treatment & minimum 2 partial seizures during baseline pd). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.|||percentage change in events||Full Range|Median
1278296|NCT00288639|Secondary|Subjects Achieving Seizure Freedom During Observation Period|Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.|Day 147 from the first dose of study drug|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period).|||participants|||Number
1278432|NCT00286741|Primary|Hemoglobin A1c||12 months||||percentage points||Standard Deviation|Mean
1278297|NCT00288639|Secondary|Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.|Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.|8 week baseline observation period & last 4 weeks of observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Patients who discontinued less than 4 weeks into the observation period (after Visit 3/week 9) will be regarded as missing. No data prior to week 9 will be used.|||participants|||Number
1278298|NCT00288639|Secondary|Number of Subjects Seizure-free|Count of subjects seizure free during the period.|last 4 weeks & whole 12 week treatment observation period|Full analysis set(FAS)/intent-to-treat(ITT) all subjects who received >= 1 dose of study Tx & >= 2 partial seizures during baseline pd. LOCF if subjects withdrew then last 4 wks prior to last dose (but after visit 3). 12 wk subjects who withdrew were regarded as missing. n= # subjects evaluable for seizure freedom during defined observation pd.|||participants|||Number
1278299|NCT00288639|Post-Hoc|Change in Partial Seizure Frequency by Type Between the 8 Week Baseline Period and During the 12 Week Observation Period.|Change from baseline = 12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate.|8 week baseline period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.|||change in median partial seizures||Full Range|Median
1278300|NCT00288639|Secondary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.|Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline period and 21 week treatment period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure date from patients who discontinued during any of these 4 week intervals will not be included in the summary for that interval.|||percentage change of events||Full Range|Median
1278301|NCT00288639|Secondary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.|Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline period and 21 week treatment period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.|||percentage change in events||Full Range|Median
1278302|NCT00288639|Primary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period|Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).|8 week baseline period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.|||percentage change in events||Full Range|Median
1278303|NCT00288626|Secondary|Percent Change From Screening in Brain Volume|Magnetic resonance imaging (MRI) scan techniques measured ventricular volumes and grey and white matter brain volumes. Change from screening was computed as the value at the time point minus the screening value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Percent Change||Standard Deviation|Mean
1278304|NCT00288626|Secondary|Change From Baseline in T1-Weighted Lesion Volume|A T1-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T1 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||milliliter||Standard Deviation|Mean
1278305|NCT00288626|Secondary|Change From Baseline in T2-Weighted Lesion Volume|A T2-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T2 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||milliliters||Standard Deviation|Mean
1278306|NCT00288626|Secondary|Number of New T2-Weighted Lesions From Baseline|A T2-weighted magnetic resonance imaging (MRI) scan was used to determine the number of new T2 lesions in the brain relative to Baseline. A value of 0 means that the participant didn’t worsen. Values greater than 0 indicate an increase in disease activity from baseline.|6 Months to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Lesions per scan||Standard Deviation|Mean
1278307|NCT00288626|Secondary|Change From Baseline in Number of Gadolinium-Enhanced Lesions|Multiple sclerosis disease-related lesions were assessed by gadolinium-enhanced magnetic resonance imaging (MRI). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Lesions per scan||Standard Deviation|Mean
1278433|NCT00286728|Secondary|Mental Health Services Use and Costs at 6 Months, 1 Year, and 2 Years||6 months, 1 year, 2 years|||||||
1278308|NCT00288626|Secondary|Change From Baseline in Extended Disability Status Scale (EDSS)|Kurtzke’s Expanded Disability Status Scale (EDSS) assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. A change of > 0.5 in EDSS was a treatment-failure criterion.|6 months to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||units on a scale||Standard Deviation|Mean
1278309|NCT00288626|Secondary|Disease-Modifying Therapy Survival Probability After Transplant|Treatment with disease-modifying therapy was measured by the number of days from transplant to the first treatment with an additional disease-modifying therapy. Examples of therapy include interferon beta-1a, glatiramer acetate, natalizumab, alemtuzumab, other immunosuppressive medications, or experimental therapies directed against MS activity. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood’s formula for standard error.|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
1278310|NCT00288626|Secondary|MS Relapse-Free Survival Probability After Transplant|"MS clinical relapse is defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit or disability, and lasting over 48 hours. Clinical relapse was determined by the participant’s neurologist and was measured as days from transplant to new or worsening neurological symptom relative to baseline.~Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood’s formula for standard error."|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
1278311|NCT00288626|Secondary|MRI Activity-Free Survival Probability After Transplant|MS disease activity is measured as days from transplant to first occurrence of >= 2 new MS lesions on Magnetic resonance imaging (MRI) relative to baseline. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood’s formula for standard error.|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
1278312|NCT00288626|Secondary|MS Progression-Free Survival Probability After Transplant|"MS progression is measured as number of days from transplant to first Kurtzke’s Expanded Disability Status Scale (EDSS) increase of more than 0.5 relative to the baseline measurement. EDSS assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS).~Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood’s formula for standard error."|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
1278313|NCT00288626|Secondary|Event-Free Survival Probability After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood’s formula for standard error.|1, 2, and 4 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
1278314|NCT00288626|Secondary|Time to Platelet Engraftment|Platelet engraftment, or platelet count recovery, is defined as Platelets > 20,000/μL for two consecutive measurements on different days with no platelet transfusions in the preceding 7 days. Normal range is 150,000-450,000/μL. Reference: http://www.hopkinsmedicine.org/heart_vascular_institute/clinical_services/centers_excellence/womens_cardiovascular_health_center/patient_information/health_topics/platelets.html.|From time of graft infusion to time of engraftment, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Days||Standard Deviation|Mean
1278315|NCT00288626|Secondary|Time to Neutrophil Engraftment|Neutrophil engraftment, or neutrophil count recovery, is defined as an Absolute Neutrophil Count (ANC) > 500/ μL for 2 consecutive measurements on different days. Normal range is 1500 to 8000/μL. Reference: http://www.medicinenet.com|From time of graft infusion to time of engraftment, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Days||Standard Deviation|Mean
1278316|NCT00288626|Secondary|Percent of Participants Who Experienced All-Cause Morbidity Within 12 Months of Post-HCT|Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher.|From the time of Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) to 1 year after HCT.|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).|||Percentage of Participants|||Number
1278317|NCT00288626|Secondary|Percent of Participants Who Experienced All-Cause Morbidity|Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher.|From the time of enrollment until completion of the 5-year follow-up, an average of 6 years.|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||percentage of participants|||Number
1279910|NCT00271544|Primary|Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)|Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])|One Month|Subjects with pacing threshold at tip electrode captured at 0.5 milliseconds (ms) at 1-month visit.|||volts||Standard Deviation|Mean
1278318|NCT00288626|Secondary|Survival From MS-Related Mortality|The probability that a participant did not experienced a MS-related death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood’s formula for standard error was used to calculate 90% confidence intervals. Participants that did not experience a MS-related death were censored at the time of last follow-up. A MS-related death was defined as death that occurred at any time after study entry and that was possibly, probably, or definitely related to disease progression.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
1278319|NCT00288626|Secondary|Overall Survival|The probability that a participant did not experienced a death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood’s formula for standard error was used to calculate 90% confidence intervals. Participants that did not die were censored at the time of last follow-up.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
1278320|NCT00288626|Secondary|Survival From Treatment-Related Mortality|The probability that a participant did not experienced a treatment-related death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood’s formula for standard error was used to calculate 90% confidence intervals. Participants that did not experience a treatment-related death were censored at the time of last follow-up. A treatment-related death was defined as death that occurred at any time after study entry and that was possibly, probably, or definitely related to the cellular product or possibly, probably, or definitely related to mobilization of autologous peripheral blood hematopoietic progenitor cells with G-CSF and prednisone or to the high-dose immunosuppressive therapy. There were no treatment-related mortality events in the study.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).|||Probability||90% Confidence Interval|Number
1278321|NCT00288626|Secondary|Event-Free Survival Probability During the 3 Years After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood’s formula for standard error.|3 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).|||Probability||90% Confidence Interval|Number
1278322|NCT00288626|Primary|Event-Free Survival Probability During the 5 Years After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood’s formula for standard error.|5 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).|||Probability||90% Confidence Interval|Number
1278323|NCT00288600|Primary|Need of Exchange Transfusion|NEED OF EXCHANGE TRANSFUSION FOLLOWING GUIDELINES|10 DAYS OF LIFE|NUMBER|||participants|||Number
1278324|NCT00288587|Secondary|Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths|Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.|Hospital discharge to 90 days after discharge|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.|||participants|||Number
1278325|NCT00288587|Secondary|Volume Removal Rate.|Hours of therapy required to remove 1 liter of fluid normalized to body weight.|Intervention start to end.|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.|||milliliters/hour/kilogram||Standard Deviation|Mean
1278326|NCT00288587|Secondary|Total Volume Removal During the Intervention Period||Intervention start to end.|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.|||milliliters||Standard Deviation|Mean
1278327|NCT00288587|Secondary|Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.||Time from admission to endpoint achievement|The analysis population was the intent-to-treat group, represented by all patients enrolled in this study.|||Days||Standard Deviation|Mean
1278328|NCT00288587|Primary|Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.||4 consecutive hours (+/- 30 minutes)|Analysis was performed on the intent-to-treat group which consisted of all patients enrolled in this study.|||hours||Standard Deviation|Mean
1278329|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS)|The YBC-EDS is an eight item, clinician-rated instrument assessing eating related preoccupations and/or rituals. Possible scores range from 0 to 32, with higher scores indicating greater preoccupations. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
1278434|NCT00286728|Primary|Psychiatric Functioning at 6 Months|Addiction Severity Index psychiatric composite ranges from 0 to 1, with 1 indicating more severe problems.|6 months|Explanation of Ns discrepant with patient flow: Ns with psychiatric severity scores at 6 months differ from those having completed the study at 2 years.|||units on a scale||Standard Deviation|Mean
1278330|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale.|The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Perfectionism subscale is comprised of six items Indicating excessive personal expectations for superior achievement. Possible scores range from 0 to 18, with higher scores indicating greater expectations. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
1278331|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale.|The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Body Dissatisfaction subscale is comprised of nine items indicating the belief that parts of the body are too large. Possible scores range from 0 to 27, with higher scores indicating greater dissatisfaction. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
1278332|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale.|The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Bulimia subscale is comprised of seven items indicating the tendency towards episodes of uncontrollable overeating (binge eating). Possible scores range from 0 to 21, with higher scores indicating greater tendency. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
1278333|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale.|The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Drive for Thinness subscale is comprised of seven items indicating excessive concern with dieting, preoccupation with weight and entrenchment in an extreme pursuit of thinness. Possible scores range from 0 to 21, with higher scores indicating greater Drive for Thinness. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
1278334|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).|The Q-LES-Q is a 93 item self-report measure of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. Each of the 93 items is scored on a five-point scale, and the total score is converted to a percentage of the maximum score possible. The range is therefore from 0 to 100, with a higher score indicating greater enjoyment or satisfaction. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||percentage of maximum possible score||Standard Error|Mean
1278335|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES).|The RSES is a 10 item self-report measure of self-esteem. Possible scores range from 0 - 30, with lower scores indicating more severe symptoms. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
1278336|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI)|The Beck Depression Inventory-II is a 21 question self-report measure of depressive symptoms. Possible scores range from 0 - 63, with higher scores indicating more severe symptoms.Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
1278337|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI)|The Beck Anxiety Inventory is a 21 question self-report measure of anxiety symptoms during the past week. Possible scores range from 0 - 63, with higher scores indicating more severe symptoms. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
1278338|NCT00288574|Secondary|Change in Weight Per Month During Treatment||12 months||||kg per month||Standard Error|Mean
1278339|NCT00288574|Primary|Proportion of Patients Remaining in Study at 1 Year|The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining > 85% Ideal Body Weight.|12 months||||proportion of participants|||Number
1278340|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS pain subscale scores have been included in the pain subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS pain subscale score analyses."|||points on a scale||Standard Deviation|Mean
1278341|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS disability subscale scores have been included in the disability subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS disability subscale score analyses."|||points on a scale||Standard Deviation|Mean
1278435|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278342|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS severity subscale scores have been included in the severity subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS severity subscale score analyses."|||points on a scale||Standard Deviation|Mean
1278343|NCT00288509|Primary|Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~Subjects with incomplete TWSTRS scores were not included in the TWSTRS total score analyses."|||points on a scale||Standard Deviation|Mean
1278344|NCT00288080|Secondary|Validity of PSA-defined Endpoints as a Surrogate for Overall Survival||From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.||2018-12-31|12/2018||||
1278345|NCT00288080|Secondary|The Time Interval Between Biochemical Failure and Distant Metastases With Respect to Testosterone Level||From date of biochemical failure to development of distant failure. Analysis occurs after all patients have been potentially followed for 4 years.||2018-12-31|12/2018||||
1278346|NCT00288080|Secondary|Incidence of Adverse Events|Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.|From start of treatment until the end of follow-up|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants|||Number
1278347|NCT00288080|Secondary|Disease-free Survival|A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method.|From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1278348|NCT00288080|Secondary|Distant Metastasis|Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method.|From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1278349|NCT00288080|Secondary|Local Control|Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method.|From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
1278350|NCT00288080|Secondary|Biochemical Control|Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization.|From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1278351|NCT00288080|Primary|Overall Survival|Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1278352|NCT00288067|Primary|Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)|The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.|Up to 7 years|No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).|||participants|||Number
1279784|NCT00272779|Secondary|Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA||Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||Ratio||95% Confidence Interval|Mean
1278353|NCT00288067|Primary|Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)|"A group of 3 patients would start treatment ast the dose of 900mg/m^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy.~Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI:~Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses >1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD."|Number of participants that experienced a dose-limiting toxicity|7 participants were analyzed in the Rituximab Naive arm and 16 participants were analyzed in the Rituximab Pre Treated Arm.|||participants|||Number
1278354|NCT00288054|Secondary|Response Rate|Confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease (as defined per RECIST). A confirmed complete response (CR) is defined as disappearance of all disease, confirmed by a second determination of CR at least 4 weeks later. A confirmed partial response (PR) is defined as a >= 30% decrease from baseline in the sum of longest diameters, confirmed by a second determination of PR at least 4 weeks later. A patient is considered to have measurable disease if they have at least one lesion with a longest diameter of >= 2 cm by conventional CT, or >= 1 cm by spiral CT.|Week 10 and week 22|Eligible patients who began protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1278355|NCT00288054|Secondary|Progression-free Survival.|Duration from the date of enrollment until the date of progression (as defined by RECIST: >= 20% increase over baseline in the sum of longest diameters, or appearance of new lesions, or non-measurable disease that is clearly worsening in the opinion of the treating investigator, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and free of disease progression are censored at the date of last contact.|At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment.|Eligible patients who began protocol treatment were included in the analysis.|||months||95% Confidence Interval|Number
1278356|NCT00288054|Secondary|Overall Survival|The duration form the date of enrollment until the date of death due to any cause. Patients last known to be alive are censored at the date of last contact.|weekly while patient is on protocol treatment, then monthly thereafter.|Eligible patients who began protocol treatment were included in the analysis.|||months||95% Confidence Interval|Median
1278357|NCT00288054|Primary|Treatment-related Esophagitis or Pneumonitis|The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.|Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.|Eligible patients who received protocol treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1278358|NCT00288054|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment.|Eligible patients who received protocol treatment.|||Participants|||Number
1278359|NCT00288015|Post-Hoc|Time to Progression|"During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment , and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage) Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0.~Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); ever 3-4 months after treatment up to 2 years||||Weeks||Standard Deviation|Mean
1278360|NCT00288015|Secondary|Evaluate the Toxicity of Bevacizumab.|"Toxicity data for bevacizumab will be collected on day 1 of every cycle (1 cycle = 21 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years.|Number of participants with either grade 1 (mild), 2 (moderate),3 (severe), 4 (life-threatening) adverse event related to treatment.|||participants|||Number
1278361|NCT00288015|Secondary|Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival|After Study drug completion, assessment of treatment effect of bevacizumab on duration of overall survival will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years||||Weeks||95% Confidence Interval|Median
1278362|NCT00288015|Secondary|Duration of Response.|During treatment, evaluation of response will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, evaluation of response will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.|Data for this outcome measure was not collected. By the time the results of the study were being collected, this outcome measure was no longer relevant as Recist 1.0 was in use. As a result, data for this outcome measure was not collected or analysed. Time to progression was a more relevant data point.||||||
1278436|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1286728|NCT00168805|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op|||Participants|||Number
1278363|NCT00288015|Secondary|Objective Response Rate in Patients Treated With Bevacizumab.|"Objective response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.~Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.||||Participants|||Count of Participants
1278364|NCT00288015|Primary|Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria.|"During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage).~Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0.~Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.||||Weeks||95% Confidence Interval|Median
1278365|NCT00287989|Secondary|Time to Progression|Median number of months until disease progression|after cycle 6 of chemotherapy||||months||95% Confidence Interval|Median
1278366|NCT00287989|Primary|Overall Response Rate|Percentage of patients who experienced complete or partial response as defined by RECIST|after 6 cycles of chemotherapy||||percentage of participants||95% Confidence Interval|Number
1278367|NCT00287872|Secondary|Quality of Life||0-6 months|Analysis not done on subject population.||||||
1278368|NCT00287872|Secondary|The Time to Response||1-6 months||||months||95% Confidence Interval|Median
1278369|NCT00287872|Secondary|Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation||1-6 months|Analysis not completed as the information was not relevant since no patients went on to transplant.||||||
1278370|NCT00287872|Secondary|Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)|Neuropathy was monitored using Total Neuropathy Score reduced (TNSr).|1-6 months||||participants|||Number
1278371|NCT00287872|Primary|Clinical Response to Treatment|Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR.|1-6 months||||percentage of participants||95% Confidence Interval|Number
1278372|NCT00287729|Secondary|Worsening of IPF|"Worsening of IPF was defined by the occurrence of any of the following events:~Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization."|Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.|||Number of Patients Who Worsened|||Number
1278373|NCT00287729|Secondary|Change in Dyspnea Score|The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5),with 0= not at all breathless, 4= severely breathless and 5= Maximally or unable to do because of breathlessness.|Baseline to Week 72|"A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.~Missing data were imputed by the SSD method if the patient was alive and imputed to a score of 120 if the patient died before the protocol-specified time point."|||Change in Dyspnea Score||Standard Deviation|Mean
1278374|NCT00287729|Secondary|Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs|The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.|||Change in Percent Predicted DLco||Standard Deviation|Mean
1278375|NCT00287729|Secondary|Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test|The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level. It is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 83% if the patient died before the protocol-specified time point.|||Change,Worst Oxygen Saturation (Percent)||Standard Deviation|Mean
1278869|NCT00282984|Secondary|Number of Long-Term Quit Responders From Week 9 Through Week 24|Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.|Week 9 through Week 24|All Participants population|||participants|||Number
1278376|NCT00287729|Secondary|Change in the Six-Minute Walk Test (6MWT) Distance|The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes as measured in meters (m).|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0 meters if the patient had died before the protocol-specified time point.|||Change in Distance Walked in Meters||Standard Deviation|Mean
1278377|NCT00287729|Secondary|Progression-free Survival|Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.|||Number of Patients with Progression|||Number
1278378|NCT00287729|Secondary|Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity|Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experience Categorical Change in Percent Predicted Forced Vital Capacity.|Baseline to week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for all efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.|||Patients|||Number
1278379|NCT00287729|Primary|Absolute Change in Percent Predicted Forced Vital Capacity(FVC)|Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.|Baseline to week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is the primary population for efficacy and safety analyses. Missing FVC data due to death were assigned the worst rank and missing FVC data due to reasons other than death were imputed using the SSD method.|||Change in Percent Predicted FVC||Standard Deviation|Mean
1278380|NCT00287716|Secondary|Worsening of Idiopathic Pulmonary Fibrosis (IPF)|"Worsening of IPF was defined by the occurrence of any of the following events:~Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization."|Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.||||Number of Patients Who Worsened|||Number
1278381|NCT00287716|Secondary|Change in Dyspnea Score|The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5), with 0 = not at all breathless, 4= severely breathless and 5 = Maximally or unable to do because of breathlessness.|Baseline to Week 72||||Change in Dyspnea Score||Standard Deviation|Mean
1278382|NCT00287716|Primary|Absolute Change in Percent Predicted Forced Vital Capacity (FVC)|Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.|From baseline up to 72 weeks||||Change in Percent Predicted FVC||Standard Deviation|Mean
1278383|NCT00287716|Secondary|Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs||Baseline to Week 72||||Change in Percent Predicted DLco||Standard Deviation|Mean
1278384|NCT00287716|Secondary|Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test|The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.|Baseline to Week 72||||Change,Worst Oxygen Saturation (Percent)||Standard Deviation|Mean
1278385|NCT00287716|Secondary|Change in Six-Minute Walk Test (6MWT)Distance|The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m).|Baseline to Week 72||||Change in Distance Walked in Meters||Standard Deviation|Mean
1278386|NCT00287716|Secondary|Progression-free Survival (PFS)|Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.|Baseline to Week 72||||Number of Patients with Progression|||Number
1278387|NCT00287716|Secondary|Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)|Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experienced a Categorical Change in Percent Predicted Forced Vital Capacity.|baseline up to 72 weeks||||Patients|||Number
1278388|NCT00287586|Secondary|Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)|The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL. The Overall Score is the average of the individual domain scores. A negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||score on a scale||Standard Deviation|Mean
1278870|NCT00282984|Secondary|Cigarettes Smoked Per Day|Cigarettes smoked each day during the first 3 weeks of the treatment phase.|Day 21|All Participants population|||cigarettes per day||Standard Deviation|Mean
1278389|NCT00287586|Secondary|Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (6 questions), orgasmic function (2 questions), sexual desire (2 questions), intercourse satisfaction (3 questions), and overall sexual satisfaction (2 questions). Each question was answered on a 5-point scale from 1 to 5 (best) with a total possible score range of 0 to 75 with higher scores representing better function. A positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||score on a scale||Standard Deviation|Mean
1278390|NCT00287586|Secondary|Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power|Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12. A negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with baseline physical function data and data available at the given time-point.|||watts||Standard Deviation|Mean
1278391|NCT00287586|Secondary|Change From Baseline in Chest Press Strength and Leg Press Strength|Maximal voluntary strength of the lower and upper extremities was assessed using the one repetition maximum (1-RM) method for the seated leg press and chest press exercises. Participants were positioned with standardized seat position and foot placement that allowed 90° of knee flexion for the leg press exercise. Seat height and handle position was standardized for the chest press. Participants were familiarized with the exercises, practiced the technique and completed a 5-minute warm-up. The 1-RM procedure consisted of a warm up set with 5 to 8 repetitions at a resistance set to about 50% of the participant’s estimated 1-RM and progressed with increasing loads interspersed with standardized rest periods until the participant was able to perform only one full-range-of-motion repetition.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with baseline physical function data and data available at the given time-point.|||newton||Standard Deviation|Mean
1278392|NCT00287586|Secondary|Change From Baseline in the Trail Making Test B|Cognitive function was assessed by the Trail Making Test B. Trail Making Test B involved participants connecting numbers (1–13) and letters (A–L) alternately (1–A, 2–B, etc) on a piece of paper as quickly as possible. Scores represent the time it takes the participant to complete the test. Less time is best and a negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||seconds||Standard Deviation|Mean
1278393|NCT00287586|Secondary|Change From Baseline in the Stroop Interference Test|Cognitive function was assessed by the Stroop Interference Test. In the Stroop Interference Test, participants were presented with a word list of colors printed in ink of a color different from how the printed word read. Participants were instructed to read aloud the color of the ink in which a word was printed, while not verbalizing the word itself. The time in seconds that the items were correctly identified was recorded. Less time is better and a negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||seconds||Standard Deviation|Mean
1278394|NCT00287586|Secondary|Change From Baseline in the Category Fluency Test|Cognitive function was assessed by the Category Fluency Test. Participants were asked to name as many items from a given category as possible. Higher number of items named is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||items||Standard Deviation|Mean
1278395|NCT00287586|Secondary|Change From Baseline in the Verbal Fluency Test|Cognitive function was assessed by the Verbal Fluency Test. Participants were asked to name as many letters from a given category as possible in 1 minute. Higher number of letters is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||letters||Standard Deviation|Mean
1278396|NCT00287586|Secondary|Change From Baseline in the Buschke Selective Reminding Test (Delayed)|Cognitive function was assessed by the Buschke Selective Reminding Test. In the Buschke Selective Reminding Test, participants were read 12 words and asked to recall as many words as possible. Subsequent trials included only those words that were not recalled in the preceding trial. Individuals were also asked to recall the list 30 minutes later. To assess phonemic and category fluency, participants were asked to name as many items from a given category as possible in 1 minute. Higher number of correct items is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||correct items||Standard Deviation|Mean
1278397|NCT00287586|Secondary|Change From Baseline in Paragraph Recall Test (Delayed)|Cognitive Function was assessed by the Paragraph Recall Test (Delayed). In the Paragraph Recall Test, participants were read two short paragraphs and asked to recall them immediately and after a 30 minute delay, using the exact words that were read aloud. Scoring was based on the number of items correctly recalled. More items correctly recalled is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||correct items||Standard Deviation|Mean
1278437|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278398|NCT00287586|Secondary|Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed)|Cognitive Function was assessed by Complex Figure (Immediate) and (Delayed). The Complex Figure Test consists of three tasks: copy, immediate recall, and delayed recall. Participants were presented with a complex design and then asked to draw the same figure. Subsequently, they were instructed to draw what they remembered immediately, and after a 30 minute delay. Scoring was based on the number of correct items for a total possible score of 0 (worst) to 36 (Best). A positive change from Baseline indicates improvement. A negative change from Baseline indicates a worsening.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||correct items||Standard Deviation|Mean
1278399|NCT00287586|Secondary|Changes in Blood Pressure||Three years|No analysis was performed. Although blood pressure measurements were standardized within a trial site, there is a possibility that measurement techniques might have varied across the three trial sites over the trial’s long duration. For this reason we decided not to include blood pressure data in the results.||||||
1278400|NCT00287586|Secondary|Changes in Biomarkers of Inflammation||Three years|No analysis was performed. No funds were left to cover the costs of the assays for inflammation biomarkers.||||||
1278401|NCT00287586|Secondary|Change From Baseline in Lipid Profiles|Laboratory tests included in the lipid profile were Total Cholesterol, High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides.Lower values for Total Cholesterol, LDL-C are better and a negative change from Baseline indicates improvement. Higher values for HDL-C are better and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||mg/dL||Standard Deviation|Mean
1278402|NCT00287586|Primary|Change From Baseline in Coronary Artery Calcium Score|A multiple detector computed tomography (MDCT) scan was performed. Proximal coronary arteries were visualized, and at least 30 consecutive images were obtained at 3-mm intervals. Coronary calcium was defined as a plaque of at least 3 contiguous pixels (area, 1.02 mm^2) with a density of more than 130 Hounsfield units.The lesion score was calculated by multiplying lesion area by a density factor derived from Hounsfield units. The Agatston method was used to determine the total calcium score by summing the lesion scores from the left main, left anterior descending, circumflex, and right coronary arteries. The Agatston score is the measure of calcification in arteries expressed on continuous scale with “0” value (better) indicating no calcification and score above 400 (worse) indicating high calcification. There is no upper limit for this measure. A positive change from baseline indicates a worsening.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||score on a scale||Standard Deviation|Mean
1278403|NCT00287586|Primary|Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)|B-mode carotid artery images for IMT were acquired from the far wall of the distal centimeter of the right carotid artery with high-resolution ultrasound equipment. IMT is used as a predictor of the incidence of cardiovascular events. An increase in the IMT thickness is associated with a higher incidence of cardiovascular events. Less thickening is best. Change is expressed in millimeters (mm).|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||mm||Standard Deviation|Mean
1278404|NCT00287365|Secondary|% Decrease in FVC in Asthmatics Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure||||percentage of FVC predicted||Standard Error|Mean
1278405|NCT00287365|Secondary|Secondary Endpoints Include Post Ozone Airway PMN Influx Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure||||percentage of cells||Standard Error|Mean
1278406|NCT00287365|Primary|Post Ozone Change in Lung Function (FEV1) Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure|Mild asthmatics exposed to ozone|||percentage of FEV1 predicted||Standard Error|Mean
1278407|NCT00287339|Primary|Change in Cough-Specific Quality of Life Questionnaire|It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, “I cannot sleep at night” and “I cough and it makes me retch.” The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is “strongly disagree,” and 4 is “strongly agree.” The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment.|baseline and 12 weeks||||participants||Standard Deviation|Mean
1278408|NCT00287222|Primary|Number of Participants Who Remained Free of Progression at the 27th Week.||27 weeks|Per protocol|||participants|||Number
1278409|NCT00287118|Primary|Percentage of Subjects With Physician’s Global Assessment (PGA) Ratings of “Excellent” or “Cleared” at Week 24|The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject’s present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.|Week 24|The Intent to Treat (ITT) population consisted of all subjects who received at least 1 dose of trial medication.|||percentage of subjects||95% Confidence Interval|Number
1278410|NCT00287079|Primary|Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates|CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.|Up to Week 96|Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Two participants had negative time from stabilization and CDMS relapse and were excluded from the Kaplan-Meier analysis.|||Month||Standard Error|Mean
1278411|NCT00287079|Secondary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Up to Week 96|"Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Adverse events were not captured for No Treatment group."|||percentage of participants|||Number
1278412|NCT00287079|Secondary|Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)|CDMS was defined as the occurrence of a second exacerbation over 96 weeks in participants who presented with CIS accompanied by an abnormal MRI scan.|Up to Week 96|Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population.|||Percentage of participants|||Number
1278413|NCT00287053|Secondary|Association of Change With a Behavioral Phenotype.||February 2006 to September 2006|||||||
1278414|NCT00287053|Secondary|Endocrine Response.||February 2006 to September 2006|||||||
1278415|NCT00287053|Secondary|Change in Body Weight.||February 2006 to September 2006|||||||
1278416|NCT00287053|Secondary|Change in Posture Allocation and Energy Expenditure.||February 2006 to September 2006|||||||
1278417|NCT00287053|Primary|Change in Food Intake.|Change in food intake from baseline to week 3.|February 2006 to September 2006||||kcal||Standard Error|Least Squares Mean
1278418|NCT00286949|Primary|Frontal Systems Behavioral Scale (FrSBe) Executive Function Subscore|Frontal Systems Behavioral Scale (FrSBe) Executive Function subscore is on of the 3 subscales of the FrSBE, a scale designed to identify and quantify behavioral problems associated with frontal lobe dysfunction. The other subscales are Apathy and Disinhibition. Each item is rated on a 5-point Likert scale. Totals are generated for each subscale and normative data is referenced (based on patient gender, age and education) and standardized T-scores are determined). For all FrSBe scales, T scores ≥ 65 are considered clinically significant and scores of 60 to 64 represent likely borderline impairment.|8 weeks||||T-score||Standard Deviation|Mean
1278419|NCT00286949|Primary|Connors Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-Long Form (CAARS-L) Inattention/Memory Subscale|The CAARS-L Inattention/Memory subscale, a primary self-rated outcome measure in this study, measures the frequency of behaviors associated with executive dysfunction, such as task incompletion, disorganization, distractibility, and difficulty planning, multi-tasking, and initiating tasks. CAARS-L scores are depicted as group Mean (SD) T scores, derived from comparison to CAARS norms based on gender and age in a normative sample. Similar to the FrSBE, higher T-scores are associated with greater symptom severity and T-scores above 65 represent symptoms of clinical significance.|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1278420|NCT00286949|Primary|Clinical Global Impression of Change-Clinician Rated Score (CGIC-C)|"CGIC-C score is a clinician's rating of change (improvement or worsening) over the course of the trial in an individual's symptoms and their global impact on function and clinical status, i.e., the global impact of the intervention that the patient is better, unchanged, or worse). Scale ranges1 to 7 which equates to from very much worse to very much improved.~The CGIC-C score is not an appropriate baseline measure since it represents change after initiating an intervention. In addition, a baseline Clinical Global Impression of Severity-Clinician Rated Score (CGIS-C) is not appropriate to compare to CGIC-C, as a patient with severe disease might show clinically meaningful improvement (i.e., very much improved) from an intervention while still being severely affected on the CGIS-C score; by contrast, a patient with mild CGIS-C could have minimal or no change on the CGIC-C score. This study was not designed to assess the influence of disease severity on the primary outcome (CGIC-C)."|8 weeks||||Participants|||Count of Participants
1278421|NCT00286754|Secondary|Medication Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.|6 months||||participants|||Number
1278422|NCT00286754|Secondary|Exercise Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.|6 months||||participants|||Number
1278423|NCT00286754|Secondary|Diet Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.|6 months||||participants|||Number
1278424|NCT00286754|Secondary|Change in Morisky Score From Baseline to 6 Months|Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent|baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
1278425|NCT00286754|Secondary|Change in Number of Cardio Exercise Hours From Baseline to 6 Months||baseline and 6 months||||hours||95% Confidence Interval|Mean
1278426|NCT00286754|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months||Baseline and 6 months||||mm Hg||95% Confidence Interval|Mean
1278427|NCT00286754|Secondary|Change in Proportion With BP Under Control From Baseline to 6 Months||6 months||||Proportion of participants|||Number
1278428|NCT00286754|Primary|Systolic Blood Pressure|Mean systolic Blood Pressure|6 months||||mm Hg||95% Confidence Interval|Mean
1278429|NCT00286754|Primary|Blood Pressure Control|Blood pressure Control at 6 months|6 months||||proportion of participants|||Number
1278438|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||kg||Standard Error|Least Squares Mean
1278439|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278440|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278441|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278442|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278443|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278444|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278445|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278446|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278447|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278448|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278449|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278450|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278451|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
1278452|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278453|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278454|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278455|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278456|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278457|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ratio||Standard Error|Least Squares Mean
1278458|NCT00286494|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mcIU/mL||Standard Error|Least Squares Mean
1278459|NCT00286494|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278460|NCT00286494|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278461|NCT00286494|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278462|NCT00286494|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278463|NCT00286494|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mcIU/mL||Standard Error|Least Squares Mean
1278464|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278465|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278466|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278467|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278468|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pmol/L||Standard Error|Least Squares Mean
1278469|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pmol/L||Standard Error|Least Squares Mean
1278470|NCT00286494|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set)and at least 1 post-baseline measurement.|||participants|||Number
1278471|NCT00286494|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set) and had at least 1 post-baseline FPG measurement.|||participants|||Number
1278472|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278473|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278474|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278475|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278476|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278477|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||mg/dL||Standard Error|Least Squares Mean
1278478|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278479|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278480|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278481|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278482|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278483|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278484|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278485|NCT00286494|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278486|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278487|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278488|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278489|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278490|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278491|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278492|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278493|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278494|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278495|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278496|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278497|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278498|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278499|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278500|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278501|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
1278502|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
1278503|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278504|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278505|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278506|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278507|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||ratio||Standard Error|Least Squares Mean
1278508|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||ratio||Standard Error|Least Squares Mean
1278509|NCT00286468|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278510|NCT00286468|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278511|NCT00286468|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1279118|NCT00281632|Secondary|Mean Change From Baseline to Response in Hemoglobin and Hematocrit|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.|||g/L||Standard Deviation|Mean
1278512|NCT00286468|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278513|NCT00286468|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||mcIU/mL||Standard Error|Least Squares Mean
1278514|NCT00286468|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||mcIU/mL||Standard Error|Least Squares Mean
1278515|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278516|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278517|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278518|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278519|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||pmol/L||Standard Error|Least Squares Mean
1278520|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||pmol/L||Standard Error|Least Squares Mean
1278521|NCT00286468|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278522|NCT00286468|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set) and have at least 1 post-baseline measurement for fasting plasma glucose.|||participants|||Number
1278523|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278524|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278525|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278526|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278527|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278528|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278529|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278530|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278531|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278532|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278533|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278534|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278535|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at week 4 due to unavailable prior value to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278536|NCT00286468|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278537|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 26).|The change between the value of glucagon collected at week 26 or final visit and glucagon collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pg/mL||Standard Deviation|Mean
1278538|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 20).|The change between the value of glucagon collected at week 20 and glucagon collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pg/mL||Standard Deviation|Mean
1278539|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 16).|The change between the value of glucagon collected at week 16 and glucagon collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pg/mL||Standard Deviation|Mean
1279911|NCT00271544|Secondary|Subjects Successfully Implanted With Model 4196 Lead|A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.|Implant|Subjects who underwent Model 4196 lead implant attempt.|||participants|||Number
1278540|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 12).|The change between the value of glucagon collected at week 12 and glucagon collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pg/mL||Standard Deviation|Mean
1278541|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 8).|The change between the value of glucagon collected at week 8 and glucagon collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).) Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pg/mL||Standard Deviation|Mean
1278542|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 4).|The change between the value of glucagon collected at week 4 and glucagon collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pg/mL||Standard Deviation|Mean
1278543|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278544|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278545|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278546|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoint due to unavailable prior values to carry forward"|||kg||Standard Error|Least Squares Mean
1278547|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278548|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278549|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278550|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278551|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278552|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278553|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278554|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278555|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278556|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278557|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278558|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
1278559|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
1278560|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278561|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278562|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278563|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278564|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ratio||Standard Error|Least Squares Mean
1278565|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||ratio||Standard Error|Least Squares Mean
1278566|NCT00286455|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ϻIU/mL||Standard Error|Least Squares Mean
1278567|NCT00286455|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ϻIU/mL||Standard Error|Least Squares Mean
1278568|NCT00286455|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ϻIU/mL||Standard Error|Least Squares Mean
1278569|NCT00286455|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ϻIU/mL||Standard Error|Least Squares Mean
1279164|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
1278570|NCT00286455|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ϻIU/mL||Standard Error|Least Squares Mean
1278571|NCT00286455|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ϻIU/mL||Standard Error|Least Squares Mean
1278572|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278573|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278574|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278575|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278576|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||pmol/L||Standard Error|Least Squares Mean
1278577|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pmol/L||Standard Error|Least Squares Mean
1278578|NCT00286455|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
1278579|NCT00286455|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL at any measurement time point during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set)and had at least 1 post-baseline FPG measurement.|||participants|||Number
1278580|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278581|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278582|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278583|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278584|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278585|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||mg/dL||Standard Error|Least Squares Mean
1278586|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278587|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
1278588|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278589|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278590|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278591|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278592|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278593|NCT00286455|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the week 26 visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278594|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278595|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278596|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278597|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278598|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
1278599|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
1278600|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
1278601|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
1278602|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
1278603|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
1278604|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
1278605|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278606|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278607|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278608|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278609|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278610|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278611|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278612|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278628|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278613|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278614|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278615|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF.|||ratio||Standard Error|Least Squares Mean
1278616|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1278617|NCT00286442|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278618|NCT00286442|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278619|NCT00286442|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278620|NCT00286442|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278621|NCT00286442|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278622|NCT00286442|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an insulin measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
1278623|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a PROINSULIN measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278624|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278625|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278626|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278627|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
1278630|NCT00286442|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.|||participants|||Number
1278631|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278632|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278633|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278634|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278635|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278636|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2. Missing data imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278637|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2.|||mg/dL||Standard Error|Least Squares Mean
1278638|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 1.|||mg/dL||Standard Error|Least Squares Mean
1278639|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 20.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278640|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 16.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278641|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 12.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278642|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 8.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278643|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278644|NCT00286442|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 26.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278645|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278646|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278647|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278648|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1278649|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|"Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.~Due to no participants in the placebo arm achieved HbA1c decrease from baseline ≥2.0%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression."|||participants|||Number
1278650|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
1278651|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
1278652|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
1278653|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
1278654|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
1278655|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|"Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 HbA1c measurement after baseline.~Due to no participants in the placebo arm achieved HbA1c ≤ 6.5%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression."|||participants|||Number
1278656|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278657|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278658|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278659|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278660|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278661|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
1278662|NCT00286429|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.|||participants|||Number
1278663|NCT00286429|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.|||participants|||Number
1278664|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278665|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278666|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278667|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278668|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278669|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278670|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 2. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278671|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 1. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1278672|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278673|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278674|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278675|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278676|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278677|NCT00286429|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF). ANCOVA = Analysis of covariance.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1278678|NCT00286325|Secondary|B Cell Number at Week 24|Peripheral blood B cell number at week 24 compared to B cell number at week 0|Week 0 and at 24 weeks|excluded subject with epidermolysis bullosa acquisita diagnosed after study entry|||B cells per microliter||Full Range|Median
1278679|NCT00286325|Secondary|IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24.|IgG antibodies against BP 180 measured in units (by ELISA) for each participant at week 0 compared to value at week 24,|Week 0 and at 24 weeks|Excluded subject with diagnosis of epidermolysis bullosa acquisita made after study entry, excluded one subject with no circulating antibodies measured at either time point.|||Elisa Units||Full Range|Median
1278680|NCT00286325|Secondary|Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24|Subject systemic corticosteroid dosage at week 24 was 25% of starting dose or 10 mg/day of prednisone or less|24 weeks|Excluded subject with epidermolysis bullosa acquisita diagnosed after study entry.|||participants|||Number
1278681|NCT00286325|Primary|Primary Safety Endpoint|The primary safety endpoint is the occurrence of treatment emergent adverse events including infections, infusion reactions and disease progression. These were determined by clinical evaluation and laboratory questions. Disease progression is defined as development of new blisters despite therapy. These are reported as the number of participants with a study related SAE.|1 year|The safety analysis was performed on all subjects|||participants|||Number
1278682|NCT00286325|Secondary|Number of Days to Cessation of New Blister|The first study visit in which patient reported and was confirmed to have no new blister or lesion formation .|1 year|Excluded subject with diagnosis of epidermolysis bullosa acquisita , made after study entry.|||Days||Full Range|Median
1278683|NCT00286221|Secondary|Fentanyl Consumption|the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption.|Up to 16 hours||||mcg/hour||Standard Deviation|Mean
1278684|NCT00286221|Primary|Hourly Pain Scores|Patients’ Numerical Rating Scale scores (0–10: 0 = no pain, 10 = worst imaginable pain)|Up to 16 hours||||units on a scale||Standard Deviation|Mean
1278685|NCT00286182|Primary|Change in Left Ventricular End-diastolic Volume|This outcome measure is collected using a three dimensional echocardiography.|Baseline and 6 month||||mL||Standard Error|Mean
1278686|NCT00286156|Secondary|Change in Total Kidney Volume as Measured by 3D-CT From Baseline to 12 Months|Total kidney volume measured by CT from baseline to 12 months|From baseline to 12 months||||ml||Standard Deviation|Mean
1278687|NCT00286156|Primary|Change in GFR From Baseline to 12 Months|GFR (glomerular filtration rate) was measured by iothalamate. GFR is a key indicator of renal function.|From baseline to 12 months||||ml/min/1.73m^2||Standard Deviation|Mean
1278688|NCT00286091|Secondary|Overall Survival|Time from randomization to the date of death. Participants who were still alive or lost to follow-up by the primary analysis data cut-off date were censored at their last contact date (on-study or during survival follow-up) or the primary analysis data cut-off date, whichever was first.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set|||days||95% Confidence Interval|Median
1278689|NCT00286091|Secondary|Time to First Bone Metastasis|Time from randomization to the date of first occurrence of bone metastasis (either symptomatic or asymptomatic), excluding death. Participants who did not develop bone metastasis were censored at their last on-study bone assessment date or the primary analysis data cut-off date, whichever was first. Median time to first bone metastasis was estimated using the Kaplan-Meier method.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set|||days||95% Confidence Interval|Median
1278865|NCT00283049|Secondary|Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.|||Percentage||Standard Deviation|Mean
1278690|NCT00286091|Primary|Bone Metastasis-free Survival|The time to the first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause. Participants who did not experience bone metastasis or on-study death were censored at the last on-study contact date or the primary analysis data cutoff date, whichever came first. Median bone metastasis-free survival time was estimated using the Kaplan-Meier method.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set (all randomized participants)|||days||95% Confidence Interval|Median
1278691|NCT00286078|Primary|Frequency of Adverse Event|Cumulative frequency of adverse events from randomization to 26 weeks|26 weeks||||events|||Number
1278692|NCT00286078|Primary|Migraine Frequency at 12 Weeks|Change from baseline in migraine days/month at 12 weeks|Baseline and 12 weeks|Modified Intent to Treat|||days||Standard Deviation|Mean
1278693|NCT00285857|Secondary|Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day||6 months|Change in mean of LDL level, with standard deviation of the values at|||mg/dL||Standard Deviation|Mean
1278694|NCT00285857|Secondary|Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day||6 months||||mg/dL||Standard Deviation|Mean
1278695|NCT00285857|Secondary|Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day|"Bilateral mammography was performed at study entry (before lovastatin therapy) and at study conclusion (after lovastatin therapy) . Mammograms were assessed for a decline in mean breast density, using the American College of Radiology Breast Imaging Reporting and Data System (BI-RAD) composition system for mammographic density assessment.~Category 0 Need additional imaging evaluation~Negative~Benign~Probably benign~Suspicious abnormality~Highly suggestive of malignancy~Known biopsy-proven malignancy"|6 months|Outcome reported as the change in mean mammographic density with standard deviation (SD) of the post-treatment measurements.|||BI-RADS||Standard Deviation|Mean
1278696|NCT00285857|Primary|Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day|"Assessed on that basis of pre- and post-treatment evaluation with RPFNA (random periareolar fine needle aspiration). All subjects received a prescription for lovastatin 80 mg/day, to be taken as 40 mg twice-a-day.~Cytology was qualitatively and quantitatively, using the Masood semiquantitative scale to assign a number to each specimen, with higher numbers indicating increasing degrees of abnormality, as follows:~06-10 Non-proliferative breast disease (NPBD)~11–14 Proliferative breast disease without atypia (PBD-A)~15–18 Proliferative breast disease with atypia (PBD+A)~19–24 Carcinoma in situ and invasive cancer (CIS/IC)~If no cells could be obtained after multiple RPFNA attempts, the classification was acellular.~Change from NPBD to PBD-A was considered Unfavorable.~Change from NPBD to Acellular was considered Equivocal.~Change from PBD-A to NPBD was considered Favorable."|6 months|"Participants either at least one of the following:~Deleterious germline mutation in BRCA1, BRCA2, CDH1, or TP53~Lifetime breast cancer risk of breast cancer of 20 % as estimated by the Claus model~Personal history of estrogen receptor andprogesterone receptor-negative breast cancer."|||participants|||Number
1278697|NCT00285818|Primary|Hamilton Depression Rating Scale Score|The Hamilton Depression Scale measures the severity of depression. There are 17 items rated 0 to 4. A total score of 0 indicates that the patient does not endorse any symptoms of depression. The maximum score (the most severe depression) is 68. The outcome measure is the difference between Visit 1 and Visit 4 Hamilton Depression Rating Scale scores of the mifepristone and placebo groups.|Screening to Final Visit||||units on a scale||Standard Deviation|Mean
1278698|NCT00285779|Secondary|The Percentage of Placebo and Study-drug Patients Able to Discontinue Use of Topical Corticosteroids Through Week 24||24 weeks|Data were not collected for this outcome measure||||||
1278699|NCT00285779|Secondary|"The Count of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of Clear) at 12 Weeks"|A complete response is defined as a score of 0 (representing “no disease”) on the Physician Global Assessment. Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. This endpoint is the number of patients on placebo that had any score other than 0 on this measure.|12 weeks|Only participants in the Placebo injection group were evaluated for this outcome measure.|||Participants|||Count of Participants
1278700|NCT00285779|Secondary|The Count of Subjects Experiencing Serious Adverse Events (SAEs) by Week 12 and Week 24|A serious adverse event was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Baseline; Week 12; Week 24||||Participants|||Count of Participants
1278701|NCT00285779|Secondary|Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks|Participants were asked to indicate their rate their overall assessment of disease severity compared to where it was at their baseline visit. The scale ranges from 0-5, with lower scores correspond to more disease improvement. 0=clear/no disease, 1=much improved (>75% improved), 2=improved (25-75%), 3=minimally improved (<25%), 4=no change, 5=worsened disease.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1278702|NCT00285779|Secondary|Patient Assessment of Pruritus (Itching) on a Visual Analogue Scale (VAS) at 12 and 24 Weeks|Participants were asked to indicate their itching level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less itching, higher scores correspond to more itching.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1278703|NCT00285779|Secondary|Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks|Participants were asked to indicate their pain level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less pain, higher scores correspond to more pain.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1278704|NCT00285779|Secondary|Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks|This score sums all of the 3 elements of the target lesion score (erythema, elevation, scale) described in Outcome Measures 6-8. Assessment scores range from 0-9 on a Likert scale, with higher numbers meaning more severe disease in the target skin lesion.|Week 12; Week 24|Participants with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1278705|NCT00285779|Secondary|Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks|This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse scaling. 0=none, 1=fine/dusty scale, 2=moderate scale, 3=thick/tenacious scale.|Week 12; Week 24|Participants with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1278706|NCT00285779|Secondary|Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks|This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse elevation. 0=flat, 1=barely palpable (<0.5 mm), 2=moderate (0.5 mm-1 mm), 3=severe (>1 mm).|Week 12; Week 24|Participants with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1278707|NCT00285779|Secondary|Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks|This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse erythema. 0=clear, 1=mild/pink, 2=moderately red, 3=severely red/violaceous.|Week 12; Week 24|Participants with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1278708|NCT00285779|Secondary|The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks|The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1278709|NCT00285779|Secondary|The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks|The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1278710|NCT00285779|Secondary|The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks|The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1278711|NCT00285779|Secondary|Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks|Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.|Baseline; Week 24||||Participants|||Count of Participants
1278712|NCT00285779|Primary|The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks|Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.|12 weeks|Intention to treat analysis (all participants received at least one dose of study drug). Missing data imputed using Last Observation Carried Forward (LOCF).|||percentage of participants|||Number
1278713|NCT00285649|Primary|Roland Morris Low Back Pain Disability Questionnaire (RMDQ)|The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.|Mean change from baseline to week 3||||units on a scale||Standard Deviation|Mean
1278714|NCT00285584|Secondary|Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.|The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment|Month 6 compared to enrollment (Month 0)||||units on a scale||Full Range|Median
1278715|NCT00285584|Secondary|Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)|Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.|Enrollment to Month 6|Self-reported and laboratory identified sexually transmitted infections|||participants|||Number
1278716|NCT00285584|Secondary|Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.|Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.|Month 6 compared to Month 0 (enrollment)|All subjects who were randomized, met study inclusion/exclusion criteria and were followed through Month 6|||Drug-using occasions per month||Full Range|Median
1278717|NCT00285584|Primary|The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.|The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.|Enrollment to Month 6|Subjects remaining in study through 6-Month study visit.|||Sexual partners||Full Range|Median
1278718|NCT00285467|Secondary|Systolic Blood Pressure at 3 Months|systolic blood pressure at 3 months|3 month||||mmHg||Standard Deviation|Mean
1278719|NCT00285467|Primary|Percent Reduction in PTH|Percent reduction in PTH from baseline to 3 months|3 month|The initial sample size was based on the published response to doxercalciferol versus placebo where a 46% reduction in PTH was observed over 6 months, with a 51% SD. The expected reduction in PTH with cholecalciferol was based on the best-case scenario decrease of 17.8% in PTH with ergocalciferol from our own clinic setting.|||% change in PTH baseline to 3 months||Standard Deviation|Mean
1278866|NCT00283049|Secondary|Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.|||Percent||Standard Deviation|Mean
1278720|NCT00285246|Primary|Health Care Utilization|This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.|pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)|Not all of the 790 completers has complete data on the healthcare utilization measure.|||number of visits in prior 12 months||Standard Deviation|Mean
1278721|NCT00285246|Primary|Mental Functional Status|Mental Component Summary Score (MCS) from the Veterans-RAND (VR) 36 (Kazis, 2000). MCS is a composite score with a mean of 50 and a standard deviation of 10. Scale scores range from 0-100 with higher scores reflecting better mental function.|pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return|Not all of the 790 completers has complete data on the mental functional status measure.|||units on a scale||Standard Deviation|Mean
1278722|NCT00285246|Primary|Physical Functional Status|Physical Component Summary Score (PCS) from the Veterans RAND (VR) 36 measure (Kazis, 2000). Composite scores are normed to a mean of 50 and a SD of 10. Scores can range from 0-100. Higher scores indicate better physical function.|pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)|Not all of the 790 completers has complete data on this physical functional status measure.|||Units on a scale||Standard Deviation|Mean
1278723|NCT00285246|Primary|Non-Specific Physical Symptoms|Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer & Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.|pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4)|Not all of the 790 completers has complete data on the non-specific physical symptoms measure.|||units on a scale||Standard Deviation|Mean
1278724|NCT00285207|Secondary|Immunologic Parameters B/T Cells Will be Assessed by B/T Cell Profile Collection.||over the course of the trial|||||||
1278725|NCT00285207|Secondary|Eradication of Human Papilloma Virus (HPV) Will be Assessed by Way of Cervical Cytology and Swab Collection.||over the course of the trial|||||||
1278726|NCT00285207|Secondary|Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0.||over the course of the trial|||||||
1278727|NCT00285207|Primary|Pathological Response|Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.|baseline and 4 months||||participants|||Number
1278728|NCT00285012|Secondary|Change From Baseline in Body Weight|Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).|Baseline, Week 52|Subjects with change in body weight in the All subjects population|||kg||Standard Deviation|Mean
1278729|NCT00285012|Secondary|Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen|Change from baseline in CRP and Fibrinogen antigen (blood markers of inflammation) calculated as mean at observation minus baseline value; measured as milligrams per deciliter (mg/dl).|Baseline, Week 12, Week 52|All subjects population; (n) = number of subjects with analyzable data at observation for varenicline and placebo, respectively.|||mg/dl||Standard Deviation|Mean
1278730|NCT00285012|Secondary|Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period|Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.|Day 1 through Day 21|All subjects population; (n) = number of subjects who smoked at least 1 cigarette at the given day for varenicline and placebo, respectively.|||cigarettes per day||Standard Deviation|Mean
1278731|NCT00285012|Secondary|Change From Baseline in Clinical COPD Questionnaire (CCQ)|Change from baseline: mean at observation minus baseline value. Subject-administered 10-item instrument to systematically assess COPD symptoms (items 1, 2, 5, and 6), functional states (items 7, 8, 9, and 10) and mental states (items 3 and 4); For each domain score = sum of items divided by the number of items; total score = sum of scores divided by 10; range from 0 (very good health) to 6 (extremely poor health). Assessed at each visit based on subject's experience during the week prior to visit.|Baseline, Week, 12, Week 24, Week 52|All subjects; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1278732|NCT00285012|Secondary|Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Change from baseline in mean FEV1 (forced expiratory volume in the first second of forced exhalation) measured in millimeters (ml) as mean at observation minus baseline value. Directly after pre-bronchodilator measurement, subject inhaled albuterol or salbutamol delivered by metered-dose inhaler (MDI); post-bronchodilator lung function repeated 30 to 45 minutes following administration of albuterol or salbutamol.|Baseline, Week 12, Week 52|All subjects population; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively. Missing data imputed by carrying the last observation forward (LOCF), including baseline values.|||ml||Standard Deviation|Mean
1278733|NCT00285012|Secondary|Number of Subjects With 4-Week Point Prevalence of Abstinence|Number of subjects at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks and with end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 52|All subjects population|||particpants|||Number
1278734|NCT00285012|Secondary|Number of Subjects With 7-Day Point Prevalence of Abstinence|Number of subjects at given visit (Week 12, Week 24, Week 52) or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. CO confirmed in-clinic visit.|Week 12, Week 24, Week 52|All subjects population|||participants|||Number
1278735|NCT00285012|Secondary|Number of Subjects With Long Term Quit Rate (LTQR)|"Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of smoking from Week 12 through the given visit (Week 24 and Week 52).~CO confirmed in-clinic visit."|Week 24, Week 52|All subjects population|||participants|||Number
1278746|NCT00284739|Secondary|Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement|This is the percentage of participants in whom their loculated abscess completely resolve with percutaneous drainage at the time of the first followup CT performed at 3 days after start of the intervention and therefore do NOT require additional surgical intervention.|3 days||||percentage of patients|||Number
1278736|NCT00285012|Secondary|Number of Subjects With Continuous Abstinence (CA)|Number of subjects who reported no smoking and no use of other nicotine-containing products (treatment phase = through week 12) or tobacco products (non-treatment phase = after treatment phase; follow up through week 52) at each contact (on the NUI) and with end-expiratory exhaled CO measurement less than or equal to 10 ppm from week 9 through week 24 and week 52. CO confirmed in-clinic visit.|Week 9 through Week 24 and Week 52|All subjects population|||participants|||Number
1278737|NCT00285012|Primary|Number of Subjects With Four Week Continuous Quit Rate (CQR)|Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory [NUI]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).|Week 9 through Week 12|All subjects population: received at least 1 dose, including partial doses, of randomized study drug.|||participants|||Number
1278738|NCT00284934|Secondary|Number of Participants With Graft and Patient Survivals at 6 Months|Graft survival was defined as the number of patients with no graft loss. The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. Patient survival was defined as the number of patients alive with or without a functioning graft.|6 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.|||Participants|||Number
1278739|NCT00284934|Secondary|Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months|A biopsy-proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB, or III based on the Banff 1997 classification.The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|6 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.|||Participants|||Number
1278740|NCT00284934|Secondary|Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)|Change in estimated glomerular filtration rate from baseline to Month 3 calculated by using abbreviated MDRD formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.|Baseline and 3 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.|||mL/min/1.73m^2||Standard Deviation|Mean
1278741|NCT00284934|Primary|Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)|Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.|Baseline and Month 6|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.|||mL/min/1.73m^2||Standard Deviation|Mean
1278742|NCT00284856|Secondary|Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period|PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR.|Baseline and 6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.|||Liters/minute||Standard Deviation|Mean
1278743|NCT00284856|Secondary|Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period|4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score.|Baseline and 6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.|||Score on a scale||Standard Deviation|Mean
1278744|NCT00284856|Primary|Percentage of Asthma-control Days Over the 6-month Treatment Period|An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.|6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who had at least 7 days of on-treatment data for the specific endpoint. Thirty three patients were excluded from the FAS (13 on montelukast, 7 on fluticasone and 13 on placebo). One participant in the placebo group did not take study medication.|||Percentage of days||Standard Deviation|Mean
1278745|NCT00284739|Secondary|Duration (in Days) of Percutaneous Drainage.|The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days.|Up to 30 days||||days||95% Confidence Interval|Mean
1278751|NCT00284518|Post-Hoc|Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers|The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.|||Score on a scale||Standard Deviation|Mean
1278752|NCT00284518|Other Pre-specified|Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain|The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||Score on a scale||Standard Deviation|Mean
1278753|NCT00284518|Secondary|Change From Baseline in Post-Void Residual|Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.|Baseline, Week 2, Week 12, Week 72|Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.|||milliliters (mL)||Standard Deviation|Mean
1278754|NCT00284518|Secondary|Change From Baseline in Transitional Zone Prostate Volume|Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||milliliters (mL)||Standard Deviation|Mean
1278755|NCT00284518|Secondary|Change From Baseline in Total Prostate Volume|Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||milliliter (mL)||Standard Deviation|Mean
1278756|NCT00284518|Secondary|Change From Baseline in Peak Urine Flow Rate|Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||milliliters (mL)/second||Standard Deviation|Mean
1278757|NCT00284518|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72|The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||Score on a scale||Standard Deviation|Mean
1278758|NCT00284518|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12|The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||Score on a scale||Standard Deviation|Mean
1278759|NCT00284180|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months||||percentage of participants||95% Confidence Interval|Number
1278760|NCT00284154|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.|18 months|All patients were assessed for progression free survival.|||Months||95% Confidence Interval|Median
1278761|NCT00284154|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Overall survival was measured from the date of study entry until the date of death.|18 months|All patients were assessed for overall survival.|||Months||95% Confidence Interval|Median
1278762|NCT00284154|Secondary|Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients’ Disease|The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.|18 months|All patients were assessed for response. Only patients with objective response were analyzed for response duration.|||Months||95% Confidence Interval|Median
1278867|NCT00283049|Secondary|Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.|||Percentage|||Number
1278763|NCT00284154|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.|18 months|All patients were assessed for response.|||percentage of participants||95% Confidence Interval|Number
1278764|NCT00284141|Secondary|Number of Participants With Anti-drug Antibodies|"Anti-drug antibodies in a participant's serum sample were assayed with an anti-drug ELISA assay, with a lower limit of quantitation of 238.4 ng/mL for an undiluted human serum sample.~Serum for anti-drug antibody analysis was collected pre-dose on every fourth cycle after Cycle 1 Day 1 (at 8 week intervals), at end of treatment (EOT), and during post-treatment follow-up 60 days after the last dose."|up to 2.5 years after initial treatment|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples.|||participants|||Number
1278765|NCT00284141|Primary|Confirmed Objective Response Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Investigator.|"OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions).~Assessments were made by the Investigator, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response."|up to 2.5 years from initial treatment|Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power.|||participants|||Number
1278766|NCT00284141|Secondary|Free and VEGF-bound Trough Aflibercept Concentrations (VEGF Trap)|"Median free and VEGF-bound trough concentrations were determined at the end of each cycle beyond Cycle 2 (Steady-state) for each participant.~Plasma free aflibercept levels were estimated by a validated direct ELISA, with an LOQ of 15.6 ng/mL. Plasma VEGF-bound aflibercept levels were also estimated by a separate validated direct ELISA with an LOQ of 43.9 ng/mL.~Mean ± SD (coefficient of variation [CV%]) values were estimated from the median values calculated for each participant."|At the end of each treatment cycle (up to 2.5 years)|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples on Day 1 of Cycle 3 for measurement of VEGF-bound aflibercept.|||micrograms/mL||Standard Deviation|Mean
1278767|NCT00284141|Secondary|Peak of Free Aflibercept (VEGF Trap)|Plasma free aflibercept levels after the first aflibercept infusion were estimated by a validated direct measured by enzyme-linked immunosorbent assay (ELISA), with a limit of quantification (LOQ) of 15.6 ng/mL.|Day 1 of the first infusion of Aflibercept (cycle 1)|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples.|||micrograms/mL||Standard Deviation|Mean
1278768|NCT00284141|Secondary|Number of Participants With Laboratory Abnormalities|"Participants with abnormal laboratory results for~Liver and renal function (Alkaline phosphatase, Alanine aminotransferase [ALT], aspartate aminotransferase [AST], Creatinine, Hyperbilirubinemia),~Electrolytes (Hypercalcemia, Hypocalcemia, Hypokalemia, Hypernatremia, Hyponatremia, Hypophosphatemia)~Metabolism (Hypoalbuminemia, Hyperglycemia, Hypoglycemia)~Hematology (Partial thromboplastin time, Anemia, Lymphopenia, Neutropenia, Thrombocytopenia, Leukopenia)"|Up to 2.5 years|All participants who received at least part of 1 dose of study treatment.|||Participants|||Number
1278769|NCT00284141|Secondary|Overall Safety - Number of Participants With Adverse Events|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 60+/-5 days after treatment discontinuation, or or until TEAE was resolved or stabilized (Collected till 18 July 2008)|All participants who received at least part of 1 dose of study treatment.|||participants|||Number
1278770|NCT00284141|Secondary|Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale|"HRQL was assessed with the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, which was completed by the participants on Day 1 of Cycle 1 only (for baseline value), then on Day 14 of each even-numbered cycle to evaluate the participants symptoms.~The questionnaire scored 7 symptoms: shortness of breath, weight loss, clarity in thinking, coughing, appetite, chest tightness, ease of breathing, on a 0-4 scale. The total FACT-LCS score ranged from 0-28 (where 28 was related to the worst outcome). To calculate a change, the baseline score was subtracted from the score obtained after treatment. A negative value implied an improvement in HRQL."|Baseline to 2.5 years|All registered participants with available questionnaires at the timepoint assessed.|||score on a scale||Standard Deviation|Mean
1278771|NCT00284141|Secondary|Overall Survival (OS)|"OS was the time interval between registration to the date of death from any cause. The median time for OS was estimated from Kaplan-Meier Plots.~A participant was to be censored for the OS analysis if the participant was alive by the study cut-off date. The censoring date was either the date that the participant was last known to be alive or the date of study cut-off, whichever came earlier."|up to 2.5 years from initial treatment|All registered participants. 38 participants were censored for OS.|||months|Participants|95% Confidence Interval|Median
1278772|NCT00284141|Secondary|Progression-free Survival (PFS) Time Assessed by the Investigator|"PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors."|up to 2.5 years from initial treatment|All registered participants. 17 participants were censored.|||weeks|Participants|95% Confidence Interval|Median
1278773|NCT00284141|Secondary|Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC)|"PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.~If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier."|up to 2.5 years from initial treatment|All registered participants. 18 participants were censored.|||weeks|Participants|95% Confidence Interval|Median
1278774|NCT00284141|Secondary|Duration of Response (DR)|DR was the time interval from the first complete response (CR) or partial response (PR) to the date of tumor progression or death from any cause, whichever was earlier. The duration of response was calculated only for those participants who achieved CR or PR.|up to 2.5 years from initial treatment|No modified RECIST responses, as confirmed by the IRC review, were observed. Only 2 responders were reported by the Investigators. Therefore, the analyses for duration of response was not performed.||||||
1278775|NCT00284141|Primary|Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC).|"OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions).~Assessments were made by the IRC, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response."|up to 2.5 years from initial treatment|Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power.|||Participants|||Number
1278776|NCT00284089|Secondary|Mean Change From Baseline in Total Retinal Volume of the Study Eye in Group B|Total retinal volume was assessed by Optical Coherence tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.|Baseline, Months 3, 6, 9 and 12|OCT was performed in a total of 58 patients at selected sites. Group B Intent-to treat (ITT) population, observed data only are included. The assessed sample size was small for total retinal volume data because the central reading center judged “Can not grade” due to retinal pigment epithelium disruption associated with CNV secondary to AMD.|||micrometers||Standard Deviation|Mean
1278777|NCT00284089|Secondary|Mean Change From Baseline in Foveal Retinal Thickness of the Study Eye in Group B|Foveal retinal thickness was assessed by Optical Coherence Tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.|Baseline, Months 3, 6, 9 and 12|The analysis includes Group B Intent-to treat (ITT) population, observed data. OCT was performed in a total of 58 patients at selected sites.|||micrometers||Standard Deviation|Mean
1278778|NCT00284089|Secondary|Percentage of Participants in Group B With Absence of Leakage in the Study Eye at Month 3, 6, 9 and 12.|Area of leakage was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed at the central reading center.|Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and for whom data was available. The Last Observation Carried Forward (LOCF) was used to impute missing data.|||Percentage of participants|||Number
1278779|NCT00284089|Secondary|Mean Change From Baseline in Total Area of Leakage From CNV Plus Staining of Retinal Pigment Epithelium of the Study Eye in Group B|Area of leakage from CNV plus staining of retinal pigment epithelium was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center. The total area is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).|Baseline, Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment. The Last Observation Carried Forward (LOCF) was used to impute missing data.|||disc areas||Standard Deviation|Mean
1278780|NCT00284089|Secondary|Mean Change From Baseline in Total Area of Choroidal Neovascularization of the Study Eye in Group B|Choroidal Neovascularization was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center. The area of Choroidal Neovascularization is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).|Baseline, Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment. The Last Observation Carried Forward (LOCF) was used to impute missing data.|||disc areas||Standard Deviation|Mean
1278781|NCT00284089|Secondary|Extension Phase: Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Last Visit of Extension Phase in Group B|"BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The following categories were evaluated:~Participants with a BCVA score loss of fewer than 15 letters from baseline at Last Visit~Participants with a BCVA score loss of 30 or more letters from baseline at Last Visit~Participants with a BCVA score gain of 15 or more letters from baseline at Last Visit~Participants with a BCVA score of less than 34 letters at Last Visit"|Baseline and last visit of extension phase - Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.|Includes patients enrolled in the extension phase, observed data.|||Participants|||Number
1278790|NCT00283959|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|"TEAEs were defined as any adverse event with a start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 48 is presented.~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Day 1 (after dosing) through Week 48 (end of extension period)|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1278782|NCT00284089|Secondary|Extension Phase: Mean Change From Month 12 (Start of Extension Phase) in Best Corrected Visual Acuity Score of the Study Eye at Last Visit of Extension Phase in Group B.|Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Month 12 (start of extension phase) and last visit of extension phase. Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.|The analysis population included all enrolled patients in the extension phase. For the analysis of the results of the extension phase, all data are presented as observed. Patients must have values both at Month 12 and Last Visit to be included.|||Letters||Standard Deviation|Mean
1278783|NCT00284089|Secondary|Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Month 6 and Month 12 in Group B|BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters.|Baseline, Month 6 and Month 12|ITT population, using LOCF.|||Participants|||Number
1278784|NCT00284089|Secondary|Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 12 in Group B|The efficacy assessment was based on Group B patients. BCVA was assessed during all study visits using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline and Month 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment of the efficacy variable. The Last Observation carried Forward (LOCF) was used to impute missing data at month 12 in the ITT analysis.|||Number of Letters||Standard Deviation|Mean
1278785|NCT00284089|Primary|Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 6 in Group B|The efficacy assessment was based on Group B patients. Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline and Month 6|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. The Last Observation Carried Forward (LOCF) was used to impute missing data at month 6 in the ITT analysis.|||Number of Letters||Standard Deviation|Mean
1278786|NCT00284050|Secondary|Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was assessed on both eyes at every study visit. These assessments were performed by trained personnel at the sites. OCT imaging was performed using the Zeiss Humphrey System Model 2000 (or later) with version A6.1 software running under Windows 95 or Windows 98. The analysis of the OCT images were performed by the Photographic Reading Center which provided a study manual and training materials. OCT operators, systems and software were certified prior to any evaluation of study patients.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.|||µm||Standard Deviation|Mean
1278787|NCT00284050|Primary|Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.|||Letters||Standard Deviation|Mean
1278788|NCT00284050|Primary|Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.|||Letters||Standard Deviation|Mean
1278789|NCT00283959|Secondary|α-Galactosidase A (α-Gal A) Activity In Peripheral Blood Mononuclear Cells (PBMC) At Baseline, Week 12, And Week 48|"PBMCs were isolated from whole blood and lysed, and α-Gal A activity was measured by a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole [nmol] 4-MU/hour [hr]) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat.~α-Gal A activity in PBMCs are presented by individual participants. Values of 0 presented below represent α-Gal A activity levels that were below the lower limit of quantification."|Baseline, Week 12 (end of treatment period), Week 48 (end of extension period)|PD Population: All participants who received at least 1 dose of study drug and had at least 1 non-missing postbaseline PD parameter recorded. Participants who discontinued prior to the specified time point were not analyzed because no data were available.|||nmol 4-MU/hr/mg protein|||Number
1278791|NCT00283933|Secondary|α-Galactosidase A (α-Gal A) Activity In Peripheral Blood Mononuclear Cells (PBMC) At Baseline, Week 24, And Week 48|PBMC were isolated from whole blood and lysed, and α-Gal A activity was measured using a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole [nmol] 4-MU/hour [hr]) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat. α-Gal A activity in leukocytes are presented by individual participants.|Baseline, Week 24 (end of treatment period), Week 48 (end of extension period)|PD Population: All participants who received at least 1 dose of study drug and had at least 1 non-missing postbaseline PD parameter recorded.|||nmol 4-MU/hr/mg protein|||Number
1278792|NCT00283933|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 48 is presented. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Week 48|Safety Population: All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1278793|NCT00283868|Secondary|Percentage of Evaluations With Technical Observations|Technical Observations: This measure was designed to assess the percentage of evaluations where there were technical observations (difficulties with using the technology) noted by the consultant who performed the evaluation (either telemedicine evaluation or telephone evaluation) in each arm of the trial.|Time of consultation||||Percentage of Evaluations|||Number
1278794|NCT00283868|Secondary|Time to Treatment Decision for Administration of Thrombolytics|time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.|potentially within 3 hours of symptom onset||||Minutes||Standard Deviation|Mean
1278795|NCT00283868|Secondary|Percentage of Total Thrombolytic Administrations|This measure assesses the number of total thrombolytic administrations that were given. This was to measure whether there were more participants treated with thrombolytics in one arm of the trial or the other.|potentially within 3 hours of symptom onset||||Percentage of participants|||Number
1278796|NCT00283868|Secondary|Percentage of Participants With Intracerebral Hemorrhage (ICH)|Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the patient was located. Any follow up imaging (head CT or MRI) was reported to the investigator team for presence of hemorrhage.|36 hours||||Percentage of participants|||Number
1278797|NCT00283868|Primary|Appropriateness of Decision to Treat or Not Treat With Thrombolytics|"This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset.~Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was appropriate to give or not give rt-PA."|potentially within 3 hours of symptom onset|Of the original 234 patients, 11 were run in patients and were not randomized and 1 was removed from any analysis due to a protocol violation resulting in the total 222 patients analyzed. There were 7 lost to follow up in telemedicine and 8 lost to follow up in telephone resulting in 104 analyzed in telemedicine and 103 analyzed in telephone.|||percentage of participants|||Number
1278798|NCT00283842|Secondary|Number of Patients With ≥50% Reduction in Mean Pain Severity Score.|Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.|Baseline and 13 weeks|The analysis population is the intent to treat.|||patients|||Number
1278799|NCT00283842|Primary|Change in Mean Pain Severity Score From Baseline to 13 Weeks|Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.|Baseline and 13 weeks|The analysis population was the intent to treat.|||units on scale||Standard Error|Mean
1278800|NCT00283816|Secondary|Change in Sex Hormone Binding Globulin (SHBG)|SHBG concentration post minus pre-intervention|baseline and 24 weeks||||nmol/L||Standard Deviation|Mean
1278801|NCT00283816|Secondary|Total Testosterone Change|Change in total testosterone post minus pre intervention|baseline and 24 weeks||||ng/dL||Standard Deviation|Mean
1278802|NCT00283816|Secondary|Change in Weight Post Minus Pre Intervention.|Body mass index change in adolescents enrolled in lifestyle intervention program|baseline and 24 weeks||||kg/m^2||Standard Deviation|Mean
1278803|NCT00283816|Primary|Reduction in Abdominal Fat as Measured by Waist Circumference.|Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention|baseline and 24 weeks||||cm||Standard Deviation|Mean
1278804|NCT00283803|Primary|Number of Participants With Dose Hold, Dose Reduction, or Treatment Withdrawal for Toxicity.|Patients were monitored for toxicity related treatment modifications from the start of Exisulind through the time that there were withdrawn from study.|From date of first treatment until study withdrawal, assessed up to 10 years.|Of 32 enrolled patients, 19 met criteria to be evaluable for study.|||Participants|||Count of Participants
1278805|NCT00283803|Primary|Time to Hormone-refractory Diseases in Patients Treated With Intermittent Androgen Suppression and Exisulind|Patients were monitored for continued hormonal sensitivity of their disease from the time of the first treatment with Intermittent Androgen Suppression and Exisulind and the time at which point they were considered hormone-refractory (castrate resistant). The development of hormone-refractory disease was one of the criteria for withdraw from study treatment. For this protocol, hormone-refractory was defined as 2 consecutive rising PSAs at least 2 weeks apart while on an LHRH agonist (with or without an anti-androgen).|From date of first treatment until the date of first documented progression or study withdrawal, whichever came first, assessed up to 10 years.|Out of 32 enrolled patients, 19 met criteria to be evaluable.|||Weeks||Full Range|Median
1278806|NCT00283803|Primary|"Duration of the First Off-treatment Cycle in Patients Who Have Completed One Cycle of Intermittent Androgen Suppression With the Addition of Exisulind."|Patients were monitored for the amount of time (number of weeks) that passed between the completion of a cycle of Intermittent Androgen Suppression with Exisulind and the need to re-initiate treatment with Intermittent Androgen Suppression. It was hoped that adding Exisulind to standard Androgen Suppression would extend the amount time before disease progression.|From date of first treatment until the date of first documented progression or study withdrawal, whichever came first, assessed up to 10 years.|Of the 32 patients who enrolled, 19 were evaluable.|||Weeks||Full Range|Mean
1278807|NCT00283712|Secondary|Participant Pemphigus Vulgaris Disease Activity Score|The Pemphigus Vulgaris Disease Activity (PVDA) score was used to grade a participant’s disease activity using the SAGE II computerized burn mapping system, which calculated the total body surface area (BSA) involved. Scores were based on the number of new lesions and blisters present, old lesion history and BSA involved. Scores range from 0 to 3 (none to severe disease activity). A new disease activity score of 3 or an old lesion score of 3 indicates active disease. New disease activity scores of 3 for a 1-month duration or an old lesion score of 3 for 2 consecutive months was cause for removal from the study treatment|Baseline to Week 26|Safety Population|||Participants|||Number
1278808|NCT00283712|Secondary|Adverse Events Resulting in Treatment Discontinuation|Adverse events experienced by participants resulting in study treatment discontinuation and assessed by the investigators as at least possibly related to treatment (i.e., possibly, probably, definitely) were assessed.|Baseline to Week 26|Safety Population|||Participants|||Number
1278809|NCT00283712|Secondary|Participants Who Experienced Severe Infectious Complications|Serious and life-threatening infections of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.|Baseline to Week 26|Safety Population|||Participants|||Number
1278810|NCT00283712|Secondary|Participants Who Experienced Severe Infusion Reactions|Participants who experienced severe infusion reactions of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.|Baseline to Week 26|Safety Population|||Participants|||Number
1278811|NCT00283712|Secondary|Participant Duration of Clinical Response|The primary efficacy endpoint of response to treatment at Week 18 was reassessed at study weeks 22 and 26 for participants who were responders at Week 18. Participants classified as responders had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. had no new blisters within the previous 4 weeks.|Baseline to Week 26|Participants in the Intent-to-Treat Population Who Were Responders at Week 18|||Participants|||Number
1278812|NCT00283712|Secondary|Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18|The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire with a weighted value to each question. The DLQI score was calculated by summing the score of each question, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the greater quality of life is impaired. Change from baseline values (defined as the visit value - baseline value) were calculated. A negative change indicates better quality of life; a positive change indicates poorer quality of life.|Baseline to Week 18|Intent-to-Treat with available data|||units on a scale||Standard Deviation|Mean
1278813|NCT00283712|Secondary|Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18|The Medical Outcome Study Short Form 36 (MOS SF-36) measures health -related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 18 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.|Baseline to Week 18|Intent-to-Treat with available data|||units on a scale||Standard Deviation|Mean
1278814|NCT00283712|Secondary|Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions|Each participant’s prednisone dose was summed from the time of enrollment until the date of 80% healing of existing erosions. Actual prednisone use per day was computed as the average over all days in the week.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Erosion Healing|||mg||Standard Deviation|Mean
1278815|NCT00283712|Secondary|Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters|Each participant’s prednisone dose was summed from the time of enrollment until the date of cessation of new blisters. Actual prednisone use per day was computed as the average over all days in the week.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Lesion Cessation|||mg||Standard Deviation|Mean
1278816|NCT00283712|Secondary|Time to 80% Lesion Healing|Time to 80% healing of existing erosions/ulcerations at time of enrollment was assessed using the SAGE II computerized burn-mapping system. The date of 80% healing of existing erosions/ulcerations at time of enrollment was defined as follows: the first date at which the percent of total body surface area (BSA) involved is at least 80% less than the percent of total BSA calculated at the time of enrollment, where the baseline percent of total BSA must be greater than zero percent. If a participant had missing post-baseline assessments, their data was censored at their last non-missing assessment date.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Lesion Healing|||Days||Standard Deviation|Mean
1278817|NCT00283712|Secondary|Participant Time to Cessation of New Blisters|Time to cessation of new blisters was defined as the time from a participant's first treatment infusion date to the first date where that date and all subsequent dates had no new blisters. Participant diaries were used to assess new blister formation. To achieve cessation, participants had to be free of new blisters at least 3 weeks prior to their last assessment. In order to analyze missing or incomplete data, the data was censored at the date where a participant had no more data or on the date where 50% of the participant’s data was missing past that point.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Cessation|||Days||Standard Deviation|Mean
1278818|NCT00283712|Secondary|Participant Modified Response Status at Week 18|Modified responder status was defined as participants achieving a prednisone dosage <=25% of the initial starting dose or <=10 mg/day (whichever is greater) at Week 18 regardless of status on new blister formation during the previous 4 weeks.|Baseline to Week 18|Intent-to-Treat|||Participants|||Number
1278820|NCT00283712|Primary|Treatment-Related Adverse Events >= Grade 3 On or Before Week 18|Grades were based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0. An adverse event (AE) was considered treatment-related if it was classified as unlikely, possibly, probably, or definitely related to study treatment. Participants who experienced at least one treatment-related, grade 3 or higher AE were counted only once. AEs of skin including rash, skin ulceration, and chelitis as defined by the NCI-CTCAE V3.0 System Organ Class of “Skin and Subcutaneous Tissues Disorders” were excluded.|Baseline to Week 18|Safety Population|||Participants|||Number
1278821|NCT00283712|Primary|Participant Response to Treatment at Week 18|Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.|Baseline to Week 18|Intent-to-Treat|||Participants|||Number
1278822|NCT00283686|Secondary|Quality of Life Mental Component Summary|Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)|baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Analysis using intention to treat.|||annual change in units on a scale||95% Confidence Interval|Mean
1278823|NCT00283686|Secondary|Quality of Life Physical Component Summary|Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)|baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Analysis using intention to treat|||annual change in units on a scale||95% Confidence Interval|Mean
1278824|NCT00283686|Secondary|All-Cause Hospitalizations||Up to 96 months|Intention to treat analysis: All participants who were randomized.|||events|||Number
1278825|NCT00283686|Secondary|Renal Blood Flow|renal blood flow (mL/min/1.73 m^2) from MRI, centrally reviewed and measured. This outcome was more difficult to measure resulting in more missing data than other MRI outcomes such as total kidney volume (TKV) and left ventricular mass index (LVMI).|0, 24 months, 48 months, 60 months|Analyses were conducted using intention to treat analyses for participants with at least one valid renal blood flow measure.|||annual change in mL/min/1.73 m^2||95% Confidence Interval|Mean
1278826|NCT00283686|Secondary|Left Ventricular Mass Index|Left ventricular mass index (g/m^2) measured by MRI, centrally reviewed and measured|0, 24 months, 48 months, 60 months|Analyses were conducted using intention to treat for participants with at least one left ventricular mass index measure.|||annual change in g/m^2||95% Confidence Interval|Mean
1278827|NCT00283686|Secondary|Aldosterone|Urinary aldosterone excretion, centrally processed, 24 hour urine collection|Up to 96 months (assessed annually)|Analysis using intention to treat|||annual % change micrograms per 24 hr||95% Confidence Interval|Mean
1278828|NCT00283686|Secondary|Albuminuria|Urine albumin excretion, centrally processed from 24 hour urine collection|Up to 96 months (assessed annually)|Analysis by intention to treat|||annual percent change in mg/24 hr||95% Confidence Interval|Mean
1278829|NCT00283686|Secondary|Kidney Function (eGFR)|The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements.|Up to 96 months (6 month assessments)|Analyses were intention to treat: All participants who were randomized.|||ml/min/1.73/m2/yr||95% Confidence Interval|Mean
1278830|NCT00283686|Primary|Study A: Percent Annual Change in Total Kidney Volume|Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up.|Baseline and 2-, 4- and 5-year follow-up|Analyses were conducted on all participants who had at least one total kidney volume measurement using intention to treat.|||percentage of Total Kidney Volume||95% Confidence Interval|Mean
1278831|NCT00283595|Secondary|IGF-1 Level|Change in IGF-1 level between baseline and 12 weeks|Baseline, 12 Weeks|The analysis group consisted of individuals who completed study visits after the baseline visit. The three subjects who did not continue in the study discontinued their participation after the baseline visit.|||ng/ml||Inter-Quartile Range|Median
1278832|NCT00283595|Primary|Bone Metabolism|Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks|Baseline, 12 weeks|Only subjects who completed study visits after the baseline visit were included in the analysis. The three subjects who discontinued the study only completed a baseline visit and were therefore not included in the analysis.|||ng/ml||Standard Error|Mean
1278833|NCT00283504|Secondary|Number Participants for Whom Sputum Induction Was Safe|safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved|every 4 weeks up to 32 weeks||||Participants|||Count of Participants
1278834|NCT00283504|Secondary|Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control||32 weeks||||Participants|||Count of Participants
1278835|NCT00283504|Primary|Number of Participants With Change in Sputum Markers by End of Study|sputum markers were classified as eosinophilic or non eosinophilic|32 weeks||||Participants|||Count of Participants
1278836|NCT00283439|Secondary|Percentage of Subjects That Received Platelet Transfusions|Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.|||Percentage of participants|||Number
1278837|NCT00283439|Secondary|Duration of Grade 3 or 4 Thrombocytopenia|Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.|||Day||Standard Error|Mean
1278838|NCT00283439|Secondary|Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia|Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.|||Percentage of participants|||Number
1278839|NCT00283439|Primary|Change in Platelet Nadir|Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.|||10^9/L||Standard Error|Mean
1278842|NCT00283400|Primary|Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome.|Tolerability outcome: Subject's ability to receive the full allocated human albumin dose without incurring frank congestive heart failure or experiencing anaphylactic reactions that required discontinuation of the treatment. Study would be terminated if 2 or more subjects developed severe or life-threatening heart failure considered to be related (probably, possibly, and definitely) to albumin treatment.|9 days after enrollment|Sample size consideration for this Phase I dose-escalation study was based on the feasibility of recruiting patients in a 3-year study period at 5 sites.The recruitment yield would be a maximum of 80 patients or 20 patients per dosage group. Statistical analyses were mainly descriptive.|||participants|||Number
1278843|NCT00283387|Primary|Urinary Oxalate Excretion|"The patients were randomly assigned oral betaine or placebo for 2 months, followed by a 2 month washout. Each patient then received the alternate study medication for 2 months.~Urinary Oxalate Excretion was measured by oxalate oxidase. Two 24 hour urine collections were obtained at baseline, and during the eighth week of each study period."|baseline, 2 months, 6 months|Per protocol analysis: 10 of 15 enrolled PHI subjects completed the study: 2 withdrew before initiation, 2 were noncompliant, in 1 symptoms led to withdrawal.|||umol/mg||Standard Deviation|Mean
1278844|NCT00283296|Primary|Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)|Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.|2 week in-home trial|Endeavor w/c|||meters/day||Standard Deviation|Mean
1278845|NCT00283296|Primary|Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)|Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.|2 week in-home trial|personal w/c|||meters/day||Standard Deviation|Mean
1278846|NCT00283296|Primary|Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle|Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle.|immediately following course completion||||participants|||Number
1278847|NCT00283244|Secondary|Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)|"The FACT-L is the FACT-G and a lung cancer specific (LCS) subscale given at baseline, after each cycle and at end of treatment. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL. The TOI-L sums the PWB, FWB, and LCS subscale scores.~A best response for TOI-L scores is based on change from baseline and coded as:~a change >=+6 “improved”, <= -6 “worsened” and otherwise “no change”.~A best overall score response is coded as:~Improved (2 visit resp. of “improved” a min. of 28 days apart w/ no interim “worsened”) No change (not “improved;” 2 visit resp. of “no change” or “improved” a min. of 28 days apart w/ no interim “worsened”) Worsened (not “improved” or “no change;” 2 consecutive “worsened”) Other (none of the above)"|After each cycle/3 weeks||||participants|||Number
1278848|NCT00283244|Secondary|Toxicity|Assessments for treatment toxicity will be done with each cycle according to CTCAE v3. Results listed here are grade >=3, treatment related hematologic events (all) and Grade>=3 treatment related non hematologic events that occurred in >=5% of patients in any arm. Adverse events (toxicities) are graded on a 5 point scale from 1 (mild) to 5 (lethal), with grades 3 and higher being severe or life threatening.|After each cycle/3 weeks, up to 3 years||||participants|||Number
1278849|NCT00283244|Secondary|Overall Survival|Survival calculated from start of treatment to death from any cause for up to three years.|Up to 3 years||||Months||95% Confidence Interval|Median
1278850|NCT00283244|Secondary|Response Rate|The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression-recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started. The response rate was defined as the percentage of patients achieving a BOR of complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Six months||||percentage of participants|||Number
1278851|NCT00283244|Primary|Progression-free Survival|We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Six months||||months||95% Confidence Interval|Median
1278852|NCT00283075|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"Dose limiting toxicity (DLT) was defined as:~any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction;~any Grade ≥ 3 infection and~any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction.~This definition of DLT is in accord with the NCI CTCAE v3.0."|6 months||||Participants who observed DLT|||Number
1278853|NCT00283075|Other Pre-specified|Tumor Marker Response|Tumor marker response after the first implantation with RENCA macrobeads. Responders showed at least a 20% decrease from baseline in Cancer Antigen 19-9 (CA19-9) or Carcinoembryonic Antigen (CEA); Non-responders do not show at least a 20% decrease from baseline in CA19-9 or CEA.|Prior to Implantation and Day 7, Day 14, Day 21 and Day 28 after each implantation|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.|||participants|||Number
1278854|NCT00283075|Secondary|Overall Survival|Overall Survival (OS) was measured as date of first implantation to date of death of any cause, and was analyzed using the Kaplan-Meier method.|From date of RENCA macrobeads implantation until date of death from any cause||||months||95% Confidence Interval|Median
1278868|NCT00283049|Primary|Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12||12 weeks from Baseline|Safety Population (excluding patients from Good Clinical Practice [GCP] non-compliant sites)|||Percentage||Standard Deviation|Mean
1278855|NCT00283075|Primary|Maximum Tolerated Dose (MTD) of RENCA Macrobeads|"Dose limiting toxicity (DLT) was defined as:~any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction;~any Grade ≥ 3 infection and~any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction.~This definition of DLT is in accord with the NCI CTCAE v3.0.~Maximum tolerated dose (MTD) was to be identified if, within a cohort, > 1 subject out of the first 3, or 2 subjects out of 5 experienced DLT. In such a case, the MTD will have been exceeded, and the administration of the study agent was to cease. MTD would not be considered to have been reached if no DLTs were observed."|6 months||||RENCA Macrobeads/kg|||Number
1278856|NCT00283062|Secondary|Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)|Number of participants with treatment-emergent adverse events (TEAE). A TEAE was as any adverse event that occurred or worsened during the on-treatment period, which was the period from the day of first infusion of study treatment until 30 days after the last infusion of study treatment.|from treatment initiation up to 19 months after treatment initiation|Safety population: all randomized participants who received any study drug|||participants|||Number
1278857|NCT00283062|Secondary|To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire|"The FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represents the best outcome.~Note: Enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn due to the low sample size."|from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline)|QoL population: The subset of randomized participants who had an evaluable baseline questionnaire and at least one evaluable post-baseline questionnaire. A baseline QoL questionnaire was considered evaluable if it was filled out within 30 days prior to randomization, and no later than the date of randomization.|||score on a scale||Standard Deviation|Mean
1278858|NCT00283062|Secondary|Median Metastasis-free Survival (MFS)|"MFS was the interval from the date of surgery to the date of the first clinical evidence of metastasis after treatment initiation. Metastasis was evaluated by a physical exam or radiologically on bone scan or CT scan. Local (palpable) progression, documented histologically or by imaging techniques was considered evidence of progression.~Median MFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median MFS was not estimated."|from the date of surgery up to 3 years after randomization of the last participant|Based on a protocol amendment, analysis for Median MFS was not to be performed as the study was underpowered.|||participants|||Number
1278859|NCT00283062|Secondary|Median Cancer-specific Survival (CSS)|"The CSS was the time from the date of surgery to the date of death due to prostate cancer.~Median CSS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median CSS was not estimated."|from the date of surgery up to 3 years after randomization of the last participant|Based on a protocol amendment, analysis for Median CSS was not to be performed as the study was underpowered.|||participants|||Number
1278860|NCT00283062|Secondary|Median Overall Survival (OS)|"Overall survival (OS) was the time interval from the date of surgery to the date of death due to any cause.~Median OS was to be estimated using Kaplan-Meier Curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Moreover, median OS could not be estimated. Reported is the number of participants who died from any cause."|from the date of surgery up to 3 years after randomization of the last participant|Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any drug.|||participants|||Number
1278861|NCT00283062|Primary|Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression|"PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of~first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks~date of the nadir, if PSA nadir did not reach < 0.4 ng/mL (for deferred arm)~first radiological/ histological evidence of tumor progression~death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression."|from the date of surgery up to 3 years after randomization of the last participant|Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any study drug.|||participants|||Number
1278862|NCT00283049|Secondary|Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia|"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.~Mild–to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL~Severe hypoglycemia: assistance of another party is required & either:~SMBG of <36 mg/dL, or~with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.~Serious hypoglycemia:~Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."|60 Weeks from Baseline|Safety Population|||events/ patient-year||Standard Deviation|Mean
1278863|NCT00283049|Secondary|Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia|"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.~Mild–to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL~Severe hypoglycemia: assistance of another party is required & either:~SMBG of <36 mg/dL, or~with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.~Serious hypoglycemia:~Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."|60 weeks from Baseline|Safety Population|||Participants|||Number
1278864|NCT00283049|Secondary|Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.|||mg/dL||Standard Deviation|Mean
1278871|NCT00282984|Secondary|Number of Responders With Continuous Abstinence (CA) Through Week 24|Responders: participants who remained abstinent based on ‘since the last contact’ question in Nicotine Use Inventory 1) “Has participant smoked any cigarettes (even a puff) since the last contact?” = No AND 2) “Has participant used any other tobacco products… since the last contact?” = No. Non- responder if the expired CO > 10 ppm at any given timepoint.|Week 9 through Week 24|All Participants population|||participants|||Number
1278872|NCT00282984|Secondary|Number of Participants With a 4 Week Point Prevalence of Smoking Cessation|Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two ‘last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study.|Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])|All Participants population|||participants|||Number
1278873|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 52||||participants|||Number
1278874|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 24||||participants|||Number
1278875|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 12|All Participants population|||participants|||Number
1278876|NCT00282984|Secondary|Number of Long-Term Quit Responders|Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.|Week 9 through Week 52|All participants population|||participants|||Number
1278877|NCT00282984|Secondary|Number of Responders With Continuous Abstinence (CA) Through Week 52|Responders: participants who remained abstinent based on ‘since the last contact’ question in Nicotine Use Inventory 1) “Has participant smoked any cigarettes (even a puff) since last contact?” = No AND 2) “Has participant used any other tobacco products… since last contact?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 9 through Week 52|All participants population|||participants|||Number
1278878|NCT00282984|Primary|Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)|Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint.|weeks 9 through 12|"Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as All Participants population in this report."|||participants|||Number
1278879|NCT00282971|Secondary|Change From Baseline in FEV1 at Week 24 LOCF||24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.FEV1=forced expiratory volume in 1 second;LOCF=last observation carried forward.|||Liter||Standard Deviation|Mean
1278880|NCT00282971|Secondary|Percentage of Participants Achieving Glycemic Control by Visit|2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%|4, 12 and 24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively. LOCF=last observation carried forward.|||Percentage of participants|||Number
1278881|NCT00282971|Primary|Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|[(week 24 value - baseline value)/baseline value]*100%|4, 12 and 24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.|||percentage change||Standard Deviation|Mean
1278882|NCT00282919|Secondary|Parasite Clearance Time|Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.|Baseline up to Day 42|Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.||||||
1278883|NCT00282919|Secondary|Fever Clearance Time|Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (<) 37.5 degree Celsius (C) (axillary temperature) or <38 degree C (oral temperature).|Baseline up to Day 42|Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.||||||
1278884|NCT00282919|Secondary|Percentage of Participants With Gametocyte Clearance|Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported.|Day 7, 14, 21, 28, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."|||percentage of participants||90% Confidence Interval|Number
1278934|NCT00282568|Secondary|Change From Baseline in Creatinine Clearance|Renal function was assessed using creatinine clearance levels calculated using the Cockcroft-Gault formula, over the course of the study.|Baseline (the last day of tacrolimus on Day 7), Day 35 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set|||mL/minute||Standard Deviation|Mean
1278885|NCT00282919|Secondary|Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42|Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here “N” (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.|Day 7, 14, 21, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."|||percentage of participants||90% Confidence Interval|Number
1278886|NCT00282919|Secondary|Percentage of Participants With Clinical Cure|Clinical Cure is defined as resolution of the participant’s fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache).|Day 3, 7, 28, and 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."|||percentage of participants||90% Confidence Interval|Number
1278887|NCT00282919|Secondary|Percentage of Participants With Resistance to Treatment|Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported.|Days 7, 14, 21, 28, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."|||percentage of participants|||Number
1278888|NCT00282919|Secondary|Percentage of Participants With Late Treatment Failures (LTF)|LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF.|Baseline up to Day 28|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."|||percentage of participants||90% Confidence Interval|Number
1278889|NCT00282919|Secondary|Percentage of Participants With Early Treatment Failures (ETF)|ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness [for example, obtundation, unarousable coma, delirium, stupor], respiratory distress [respiratory rate greater than or equal to {>=} 30 breaths/minute], seizures, hypoglycemia [glucose less than or equal to {<=} 40 milligram/deciliter], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 > Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 > 37.5 degrees Celsius (axillary temperature) and >38 degrees Celsius (oral temperature) and parasite count on Day 3 >=25 percent (%) of the first available parasite density on Day 0 (baseline).|Baseline up to Day 28|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."|||percentage of participants||90% Confidence Interval|Number
1278890|NCT00282919|Primary|Percentage of Participants With Parasite Clearance at Day 28|Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here “N” (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.|Day 28|Parasitological per protocol (PP) population: Participants who had study drug for 3 days unless treatment failure, no concomitant anti-malarial unless designated treatment failure, had test of cure at Day 28, baseline smear with parasitemia between 1000-100000 parasites/microliter, rapid diagnostic test positive for P falciparum, history of fever.|||percentage of participants||90% Confidence Interval|Number
1278891|NCT00282867|Post-Hoc|Target Glucose Concentration|glucose in target range in first 24 hours|first 24 hours after initiation of treatment|"Per protocol no analysis of this endpoint was performed in the usual care group."|||participants|||Number
1278892|NCT00282867|Other Pre-specified|Symptomatic Hypoglycemia|symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period|up to 5 days||||participants|||Number
1278893|NCT00282867|Primary|Hypoglycemic Events|hypoglycemic events|up to 5 days||||participants|||Number
1278894|NCT00282867|Secondary|Favorable 3 Month Modified Rankin|3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.|3 months||||percentage of participants|||Number
1278895|NCT00282828|Secondary|Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). We analyzed the overall change in LSAS (last Phase II LSAS minus Week 10 LSAS). Higher numbers reflect greater drops in social anxiety disorder severity. Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.|Change from Week 10 to Week 22|This analysis was conducted in Phase I non-responders, randomized to receive 12 weeks of continued sertraline plus the addition of clonazepam, switch to venlafaxine, or prolonged sertraline plus placebo.|||units on a scale||Standard Deviation|Mean
1278896|NCT00282828|Primary|Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.|Measured at Week 22 (Endpoint)|The present analysis was conducted in the modified ITT population (n=181), with remission based on week 22 LSAS for study completers (n=154, and last Phase II LSAS for the 27 patients who terminated early.|||participants|||Number
1278897|NCT00282815|Secondary|Barthel Index|Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).|3 months||||units on a scale (range 0-100)||Inter-Quartile Range|Median
1278898|NCT00282815|Primary|Number of Subjects Who Withdraw From Study.|Prespecified outcome.|3 months||||participants|||Number
1278899|NCT00282815|Primary|Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.||3 months|Data not available on one sham participant (lowering n from 11 to 10 in the shame group).|||Hours/participant||Inter-Quartile Range|Median
1278900|NCT00282672|Secondary|5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years.||5 years||||percentage of participants|||Number
1278901|NCT00282672|Secondary|5 Year Extension: Serious Adverse Event Incidence||5 years||||participants|||Number
1278902|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year||4 years||||percentage of participants|||Number
1278903|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year||3 years||||percentage of participants|||Number
1278904|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year||4 years||||percentage of participants|||Number
1278905|NCT00282672|Secondary|5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year||5 years||||percentage of participants|||Number
1278906|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year||5 years||||percentage of participants|||Number
1278907|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body After 2 Years and Inclusive of the 5 Year Visit||5 years|Similar analysis was performed and the result is provided for the outcome measure #14. The data were collected to answer the outcome measure #14.||||||
1278908|NCT00282672|Secondary|For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years)||5 years|41 LGD patients and 21 HGD subjects completed the 5 year study and used for analysis.|||percentage of participants|||Number
1278909|NCT00282672|Secondary|Adverse Event Incidence|Data reported in the adverse event section|12 months for Treatment and Sham Comparison||||Adverse event occurrences|||Number
1278910|NCT00282672|Secondary|Quality of Life Questionnaire (Baseline v. 12 and 24 Mos)||0, 12, and 24 months|Data had not been collected consistently to analyze the data.||||||
1278911|NCT00282672|Secondary|Subject Discomfort : Chest Pain Score on Day 1|Chest pain score was measured on a visual analogue scale of 0 to 100, with higher scores indicating a greater severity of pain|Day 1 , if ablated||||Scores on a scale||Inter-Quartile Range|Median
1278912|NCT00282672|Secondary|Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma)||5 year||||participants|||Number
1278913|NCT00282672|Secondary|Histological Clearance of IM (% Biopsies)|% of patients with histological clearance of IM out of the number of participants analyzed at 12 month was calculated.|12 months||||percentage of participants|||Number
1278914|NCT00282672|Secondary|Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups.||12 Month|16 HGD Sham procedure subjects crossed over to RFA treatment after one year|||percentage of participants|||Number
1278915|NCT00282672|Secondary|The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup||12 months||||percentage of participants|||Number
1278916|NCT00282672|Primary|5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years|For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of dysplasia was calculated and all were free of dysplasia|5 years||||percentage of participants|||Number
1278917|NCT00282672|Primary|Durability of Eradication With no Additional Treatments||5 year|41 LGD subjects and 32 HGD subjects completed 5 year visit|||percentage of participants|||Number
1278918|NCT00282672|Primary|5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years|For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of intestinal metaplasia (CE-IM) was calculated.|5 years|patient who made it to the 5 year visit|||percentage of participants|||Number
1278919|NCT00282672|Primary|The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months.|% of patients with complete eradication of IM out of the number of participants analyzed at 24 month was calculated.|24 Month||||percentage of participants|||Number
1278920|NCT00282672|Primary|The % of Patients With Complete Eradication of Dysplasia at 12 Month|% of patients with complete eradication of Dysplasia out of the number of participants analyzed at 12 month was calculated.|12 month|LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-D at one year.|||percentage of participants|||Number
1283070|NCT00233090|Secondary|Sleep Quality|sleep quality|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
1278921|NCT00282672|Primary|The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month|% of patients with complete eradication of IM out of the number of participants analyzed at 12 month was calculated.|12 month|LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-IM at one year.|||percentage of participants|||Number
1278922|NCT00282568|Secondary|Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs|"An adverse event was defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the day of last dose plus 10 days (approximately 60 months).|Modified safety analysis set|||participants|||Number
1278923|NCT00282568|Secondary|Number of Participants Returning to Permanent Dialysis|Permanent dialysis defined as dialysis for longer than 30 days.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
1278924|NCT00282568|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant or permanent return to dialysis) or death. GBM = glomerular basement membrane.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.|||participants|||Number
1278925|NCT00282568|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 60 months).|||||||
1278926|NCT00282568|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 60 months).|||||||
1278927|NCT00282568|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
1278928|NCT00282568|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
1278929|NCT00282568|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
1278930|NCT00282568|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|"Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported."|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||participants|||Number
1278931|NCT00282568|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection, the median number of days from enrollment to the date of biopsy confirmation. Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||days||Full Range|Median
1278932|NCT00282568|Secondary|Time to Event for Graft Non Survival|For participants with graft loss, the median number of days from enrollment to graft loss. Graft loss was defined as graft failure (re-transplant or permanent return to dialysis (for more than 30 days)) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.|||days||Full Range|Median
1278933|NCT00282568|Secondary|Time to Event for Patient Non Survival|For participants who died on study, the median number of days from enrollment to death due to any cause.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set who died on study.|||days||Full Range|Median
1279119|NCT00281632|Secondary|Mean Change From Baseline to Response in Thyroid Stimulating Hormone|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||milliunits per liter (MU/L)||Standard Deviation|Mean
1278935|NCT00282568|Secondary|Change From Baseline in Serum Creatinine|Renal function was assessed using serum creatinine levels over the course of the study.|Baseline (the last day of tacrolimus on Day 7), Day 35 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus and at least one dose of tacrolimus MR during the pharmacokinetic portion of the study. “N” indicates the number of participants with available data at each time point.”|||mg/dL||Standard Deviation|Mean
1278936|NCT00282568|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant or permanent return to dialysis (for more than 30 days)) or participants death.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extension portion of the study.|||percentage of participants||95% Confidence Interval|Number
1278937|NCT00282568|Primary|Patient Survival|Patient Survival defined as any participant who did not die by the time of analysis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extension portion of the study.|||percentage of participants||95% Confidence Interval|Number
1278938|NCT00282568|Primary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|The time to reach the maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the trough evaluable set defined as all patients with replicate trough measurements for both tacrolimus and tacrolimus MR.|||hours||Standard Deviation|Mean
1278939|NCT00282568|Primary|Minimum Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 24-hour time point post- dose, prior to receiving the next dose.|Days 1 and 7 (tacrolimus) and Days 14 and 21 (tacrolimus MR), 24 hours post-dose.|The number of participants analyzed represents the trough evaluable set defined as all patients with replicate trough measurements for both tacrolimus and tacrolimus MR.|||ng/mL||Standard Deviation|Mean
1278940|NCT00282568|Primary|Maximum Observed Concentration (Cmax) of Tacrolimus|The maximum concentration was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the Pharmacokinetic evaluable set.|||ng/mL||Standard Deviation|Mean
1278941|NCT00282568|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||percentage of participants||95% Confidence Interval|Number
1278942|NCT00282568|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the trapezoidal rule.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the Pharmacokinetic evaluable set, defined as patients with all five complete pharmacokinetic profiles (two tacrolimus and three tacrolimus MR).|||ng*hr/mL||Standard Deviation|Mean
1278943|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint|Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward.|Baseline to Week 6 (endpoint)|Endpoint is Intent to Treat (ITT) Last Observation Carried Forward (LOCF). n = 140, 162; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
1278944|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer|Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.|Baseline to week 6 (endpoint)|Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 137, 158; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
1278945|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating|Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF.|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 97, 104; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
1278946|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject|Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 141, 164; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
1278947|NCT00282464|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30.|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 149, 162; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
1278948|NCT00282464|Secondary|Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score|Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80.|Baseline to week 6 (endpoint)|Change from baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 153, 168; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
1278949|NCT00282464|Secondary|Change in Global Assessment of Functioning (GAF)|Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality.|Baseline to week 6 (Endpoint)|Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 154, 169; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
1278950|NCT00282464|Secondary|Change in Global Clinical Improvement of Symptoms (CGI -I)|Change is observed value at each visit minus baseline value. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range:0=not assessed, 1=very much improved, 7=very much worse|Baseline to Week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."|||score on scale||Standard Error|Least Squares Mean
1278951|NCT00282464|Secondary|Change in Global Clinical Severity of Symptoms (CGI-S)|Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill|Baseline to week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."|||score on scale||Standard Error|Least Squares Mean
1278952|NCT00282464|Secondary|Change in Total Score of Young Mania Rating Scale (YMRS)|Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. Overall is average response Week 1 - 6.|Baseline to week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."|||score on scale||Standard Error|Least Squares Mean
1278953|NCT00282464|Secondary|Change in Hamilton Anxiety Rating (HAM-A)|Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
1278954|NCT00282464|Secondary|Change in Sleep Disturbance Factor Score|Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||score on scale||Standard Error|Least Squares Mean
1278955|NCT00282464|Secondary|Change in Retardation Factor Scores|Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
1278956|NCT00282464|Secondary|Change in Anxiety/Somatizations Factor Total Score|Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
1278957|NCT00282464|Secondary|Change in Bech Melancholia Score|Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat(ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
1278958|NCT00282464|Secondary|Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)|Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
1278959|NCT00282464|Secondary|Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
1278960|NCT00282464|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.|Baseline to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 - 6."|||score on scale||Standard Error|Least Squares Mean
1278961|NCT00282464|Secondary|Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7|Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF.|Week 3, Week 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||Participants|||Number
1278962|NCT00282464|Secondary|Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12|Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.|Week 1 to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||Participants|||Number
1278963|NCT00282464|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF.|Baseline to Week 3, Week 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||Participants|||Number
1278964|NCT00282464|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score|Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)|Baseline to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||participants|||Number
1278965|NCT00282438|Primary|Time to Disease Progression|Worsening symptoms, pulmonary function studies, cardiac function and arrhythmia including EKG assessments, and neurological symptoms.|Participants are to be followed at 6 months and then yearly until 5 years||||months|||Number
1278966|NCT00282438|Primary|Survival|Patient has not died.|Participants are to be followed at 6 months and then yearly until 5 years||||Participants|||Count of Participants
1278967|NCT00282438|Primary|Presence of Toxicity|Daily assessment will be made with regards to toxicity by one of the protocol investigators.National Cancer Institute Common Toxicity Criteria will be used to grade all non-hematologic toxicities. Toxicity grades as follows: 1 = Mild; 2 = Moderate; 3 = Severe and undesirable; 4 = life threatening or disabling ; 5 = Death|For length of hospital stay (until discharge).||||participants|||Number
1278968|NCT00282412|Primary|Survival|The number of participants who survived treatment|up to 5 years|The number of participants who survived treatment|||Participants|||Count of Participants
1278969|NCT00282347|Secondary|Change From Baseline in C3 and C4 Complement Levels at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||mg/dL||Standard Deviation|Mean
1278970|NCT00282347|Secondary|Change From Baseline in Anti-double-stranded DNA at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||IU/mL||Standard Deviation|Mean
1278971|NCT00282347|Secondary|Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52|The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Units on a scale||Standard Deviation|Mean
1278972|NCT00282347|Secondary|Time to Achieve a Complete Renal Response||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Weeks||95% Confidence Interval|Median
1278973|NCT00282347|Secondary|British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks|The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Units on a scale||Standard Deviation|Mean
1278974|NCT00282347|Secondary|Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo). Only those participants with a Baseline urine protein to creatinine ratio of > 3.0 were included in the analysis.|||Percentage of participants|||Number
1279031|NCT00282243|Secondary|Change From Baseline in Total Bilirubin|Hepatic function was assessed by measuring total bilirubin over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|"Modified safety analysis set. N indicates the number of participants with available data at each time point."|||mg/dL||Standard Deviation|Mean
1278975|NCT00282347|Secondary|Percentage of Participants Who Achieved a Complete Renal Response at Week 52|A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.|Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Percentage of participants|||Number
1278976|NCT00282347|Secondary|Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52|A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.|Week 24 to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Percentage of participants|||Number
1278977|NCT00282347|Primary|Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52|A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR.|Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Percentage of participants|||Number
1278978|NCT00282334|Primary|Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months|Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups|baseline and 6 months|Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up.|||mm Hg||Standard Deviation|Mean
1278979|NCT00282334|Primary|Difference in Number of Patients Who Reached Target Blood Pressure||6 months|||||||
1278980|NCT00282308|Secondary|Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|Safety population: All patients who received any amount of rituximab or any vaccine. Since only limited efficacy data were collected in this study, the parameters necessary to calculate the ACR20/50/70 responses were only available for patients in Group A.|||Percentage of patients|||Number
1278981|NCT00282308|Secondary|Percentage of Patients Who Maintained a Positive Response to the C. Albicans Skin Test From Day 1 to Week 24 for Group A or From Day 1 to Week 12 for Group B|Patients received an intradermal injection of C. albicans on the volar surface of the forearm on Day 1 and Week 24 for Group A or on Day 1 and Week 12 for Group B. Forty-eight to 72 hours after injection, patients were evaluated for a delayed-type hypersensitivity response by measuring the diameter of induration (palpable raised, hardened area of the forearm skin). A positive response to the C. albicans skin test was defined as at least 5 mm in diameter of induration.|Day 1 to Week 24 for Group A and Day 1 to Week 12 for Group B|Skin test per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion, had Day 1 and Week 24 skin tests, and who provided complete diameter of induration readings. Group B – All patients randomized to Group B who had Day 1 and Week 12 skin tests and who provided complete diameter of induration readings.|||Percentage of patients|||Number
1278982|NCT00282308|Secondary|Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin|Anti-keyhole limpet hemocyanin antibody was measured immediately prior to and 4 weeks after the first administration of keyhole limpet hemocyanin. The keyhole limpet hemocyanin antibody ELISA assay used keyhole limpet hemocyanin as the plate coat and anti-human IgG-horseradish peroxidase for detection.|Week 32 to Week 36 for Group A and Week 8 to Week 12 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||IU/mL||95% Confidence Interval|Geometric Mean
1279032|NCT00282243|Secondary|Change From Baseline in Aspartate Aminotransferase (AST)|Hepatic function was assessed by measuring aspartate aminotransferase levels over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set. “N” indicates the number of participants with available data at each time point.|||U/L||Standard Deviation|Mean
1278983|NCT00282308|Secondary|Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide Vaccine|Anti-pneumococcal antibody was measured immediately prior to and 4 weeks after administration of a 23-valent pneumococcal polysaccharide vaccine. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||µg/mL||95% Confidence Interval|Geometric Mean
1278984|NCT00282308|Secondary|Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine|Anti-tetanus antibody was measured in serum samples immediately prior to and 4 weeks after administration of a tetanus toxoid adsorbed booster vaccine. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||IU/mL||95% Confidence Interval|Geometric Mean
1278985|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
1278986|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to at Least 50% (≥ 6 of 12) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
1278987|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
1278988|NCT00282308|Secondary|Percentage of Patients With a 2-fold Increase in Tetanus Antibody Titers or With Tetanus Antibody Titers ≥ 0.2 IU/mL in Response to Tetanus Toxoid Adsorbed Booster Vaccine|The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
1279030|NCT00282243|Secondary|Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs|"An adverse event is defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 60 months).|Modified safety analysis set.|||participants|||Number
1278989|NCT00282308|Primary|Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine|The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus antibody titers ≥ 0.1 IU/mL, a positive immune response to the booster immunization was defined as a 4-fold increase in antibody titer.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
1278990|NCT00282295|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (Day 0 - Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1278991|NCT00282295|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE =An AE which prevented normal, everyday activities. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination.|Within the 31-day (Days 0-30) period after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1278992|NCT00282295|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms [gastro sympt]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.|Within 4-days (Days 0-3) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||Participants|||Count of Participants
1278993|NCT00282295|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).|Within 4-days (Day 0-3) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||Participants|||Count of Participants
1278994|NCT00282295|Secondary|Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies|Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra vaccine.|At Month 2 (one month after vaccination with Menactra vaccine)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1278995|NCT00282295|Secondary|Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies|Antibody titers are presented as geometric mean titers (GMTs).|PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Titers||95% Confidence Interval|Geometric Mean
1278996|NCT00282295|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Month 2 (one month post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol|||EL.U/mL||95% Confidence Interval|Geometric Mean
1278997|NCT00282295|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Day 0 before (PRE) Boostrix vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1278998|NCT00282295|Secondary|Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.|At Month 2 (one month post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1278999|NCT00282295|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||IU/mL||95% Confidence Interval|Geometric Mean
1279000|NCT00282295|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||IU/mL||95% Confidence Interval|Geometric Mean
1279001|NCT00282295|Secondary|Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|"Booster responses for anti-D and anti-T antibodies were defined as:~for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine."|At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1279002|NCT00282295|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).|PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1279003|NCT00282295|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Month 2 (one month post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1279004|NCT00282295|Secondary|Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Day 0 (PRE) before Boostrix vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1279005|NCT00282295|Primary|Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)|Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine.|One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1279066|NCT00282087|Secondary|Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)|AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only|2 years||||participants|||Number
1279006|NCT00282295|Primary|Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|"Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as:~for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine."|At Month 1 (post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1279007|NCT00282295|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1 (post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol|||EL.U/mL||95% Confidence Interval|Geometric Mean
1279008|NCT00282295|Primary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Month 1 (post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available and (&) randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
1279009|NCT00282282|Secondary|Disease Response.|Disease response was assessed as 2 year progression-free survival. The median follow-up time was 1.84 years. The percentage of participants with who reached this timepoint with no disease progression are reported.|2 years||||percentage of participants||95% Confidence Interval|Number
1279010|NCT00282282|Secondary|Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation|The percentage of participants with ≥90 percent donor-derived hematopoeisis was assessed around day +100 using peripheral blood chimerism.|100 days||||percentage of participants|||Number
1279011|NCT00282282|Primary|Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus.|All participants received tacrolimus and sirolimus in this one arm study. There were no participants considered unevaluable for this measure (deceased prior to day 100). The total number of people who developed grade II-IV aGVHD before day 100 are reported here.|100 days|Participants who lived more than 30 days posttransplant were considered evaluable. Incidence of grade II-IV aGVHD was adjusted for participants who had aGVHD off-treatment.|||participants|||Number
1279012|NCT00282256|Secondary|Safety as Assessed by Clinical Signs and Symptoms, Laboratory Parameters and Diagnostic Tests|"An adverse event (AE) is defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 54 months).|Modified safety analysis set defined as all participants who took at least 1 dose of both tacrolimus and tacrolimus MR formulation during the pharmacokinetic period of the study.|||participants|||Number
1279013|NCT00282256|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with graft loss.|||participants|||Number
1279014|NCT00282256|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 54 months).|||||||
1279015|NCT00282256|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 54 months).|||||||
1279016|NCT00282256|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||participants|||Number
1279017|NCT00282256|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||participants|||Number
1279018|NCT00282256|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||participants|||Number
1279067|NCT00282087|Secondary|Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)||2 years||||participants|||Number
1279019|NCT00282256|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||participants|||Number
1279020|NCT00282256|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||days||Full Range|Median
1279021|NCT00282256|Secondary|Time to Event for Graft Non-survival|For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with graft loss.|||days||Full Range|Median
1279022|NCT00282256|Secondary|Time to Event for Patient Non-survival|For participants who died on study, the median number of days from first dose of study drug to death due to any cause.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set who died on study.|||days||Full Range|Median
1279023|NCT00282256|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte. necrosis|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||percentage of participants|||Number
1279024|NCT00282256|Secondary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|Time to reach the first observed maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set.|||hours||Full Range|Median
1279025|NCT00282256|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||percentage of participants||95% Confidence Interval|Number
1279026|NCT00282256|Primary|Patient Survival|Patient survival was defined as any participant known to be alive at the end of the study.|From enrollment until the end of study (up to 54 months).|The Modified Full Analysis Set included all patients who took at least 1 dose of tacrolimus MR formulation during the extended treatment period.|||percentage of participants||95% Confidence Interval|Number
1279027|NCT00282256|Primary|Minimum Observed Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose.|Day 7 at 12 hours post-dose (tacrolimus) and Day 14 at 24 hours post-dose (tacrolimus MR).|Pharmacokinetic evaluable set.|||ng/mL||Standard Deviation|Mean
1279028|NCT00282256|Secondary|Maximum Observed Concentration of Tacrolimus (Cmax)|The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set.|||ng/mL||Standard Deviation|Mean
1279029|NCT00282256|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 and AUC 12-24 for the morning and afternoon doses.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The pharmacokinetic evaluable set was defined as all patients who completed both pharmacokinetic profiles: one for tacrolimus, and one for tacrolimus MR. A complete pharmacokinetic profile was considered to be a profile that was adequate to determine AUC0-24, Cmax, and Cmin.|||ng*hr/mL||Standard Deviation|Mean
1279033|NCT00282243|Secondary|Change From Baseline in Alanine Aminotransferase (ALT)|Hepatic function was assessed by measuring alanine aminotransferase levels over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|"Modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus and at least one dose of tacrolimus MR during the pharmacokinetic portion of the study. N indicates the number of participants with available data at each time point."|||U/L||Standard Deviation|Mean
1279034|NCT00282243|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.|||participants|||Number
1279035|NCT00282243|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 60 months).|||||||
1279036|NCT00282243|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 60 months).|||||||
1279037|NCT00282243|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
1279038|NCT00282243|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
1279039|NCT00282243|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
1279040|NCT00282243|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||participants|||Number
1279041|NCT00282243|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||days||Full Range|Median
1279042|NCT00282243|Secondary|Time to Event for Graft Non-survival|For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.|||days||Full Range|Median
1279043|NCT00282243|Secondary|Time to Event for Patient Non-survival|For participants who died on study, the median number of days from first dose of study drug to death due to any cause.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set who died on study.|||days||Full Range|Median
1279044|NCT00282243|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||percentage of participants||95% Confidence Interval|Number
1279068|NCT00282087|Secondary|Correlation Between Age and Tumor Response to Treatment (PFS)||2 years||||years||Full Range|Median
1283071|NCT00233090|Secondary|Pain|pain|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
1279045|NCT00282243|Secondary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|Time to the first occurrence to reach the maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state, without interpolation.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set|||hours||Standard Deviation|Mean
1279046|NCT00282243|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||percentage of participants||95% Confidence Interval|Number
1279047|NCT00282243|Primary|Patient Survival|Patient survival was defined as any participant known to be alive at the time of analysis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extended treatment period of the study.|||percentage of participants||95% Confidence Interval|Number
1279048|NCT00282243|Primary|Minimum Observed Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose.|Days 14 and 42 at 12 hours post-dose (tacrolimus) and Days 28 and 56 at 24 hours post-dose (for tacrolimus MR).|Pharmacokinetic evaluable set|||ng/mL||Standard Deviation|Mean
1279049|NCT00282243|Secondary|Maximum Observed Concentration of Tacrolimus (Cmax)|The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state, without interpolation.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set|||ng/mL||Standard Deviation|Mean
1279050|NCT00282243|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 for the morning (0-12 hour) and afternoon (12-24 hour) doses.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set defined as all patients with four complete pharmacokinetic profiles (two tacrolimus and 2 tacrolimus MR).|||ng*hr/mL||Standard Deviation|Mean
1279051|NCT00282152|Secondary|Change in Total UPDRS|"The Total Unified Parkinson’s Disease Rating Scale (UPDRS) is a composite scale, consisting of four sections that evaluate mood and behavior, activities of daily living, motor symptoms, and complications of medical therapy.~Range is 0 to 16, with 16 being maximal disability"|baseline to 24 months||||units on a scale||95% Confidence Interval|Mean
1279052|NCT00282152|Secondary|Change in UPDRS Part IV, Complications of Therapy|Score: 0-23 0 =no complications, 23 = most complications|baseline to 24 months||||units on a scale||95% Confidence Interval|Mean
1279053|NCT00282152|Secondary|Change in UPDRS Part III, Motor Examination, Excluding Rigidity|Score: 0-56 0 = full movement, 56 = most limited|baseline to 24 months||||change in units on a scale||95% Confidence Interval|Mean
1279054|NCT00282152|Secondary|Change in UPDRS Part II, Activities of Daily Living|Score: 0-52 0 =normal, 52 = most limited|baseline to 24 months||||units on a scale||95% Confidence Interval|Mean
1279055|NCT00282152|Secondary|Change in UPDRS Part I, Mentation Behavior and Mood|Score: 0-16 0 =normal, 16 = most disability|baseline to 24 months||||units on a scale||95% Confidence Interval|Mean
1279056|NCT00282152|Primary|Levodopa Equivalents, Change From Baseline|100 mg of levodopa with a dopa-decarboxylase inhibitor = 133 mg of controlled-release levodopa preparations = total levodopa dose + (total levodopa dose x 0.33) of levodopa with dopa-decarboxylase and entacapone = 1 mg of pergolide, pramipexole, or lisuride = 5 mg of ropinirole = 3.3 mg of rotigotine|baseline to 24 months||||mg||95% Confidence Interval|Mean
1279057|NCT00282152|Primary|Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Score|The primary hypothesis of this feasibility trial was focused on safety and tolerability and that the DBS+ODT group would not worsen more quickly than the ODT group.|baseline to 24 months|all 29 subjects that completed at least one follow up visit were included in the primary analysis following intent to treat principle|||months||95% Confidence Interval|Mean
1279058|NCT00282113|Secondary|Stool Short Chain Butyric Acid Content||4 weeks||||nmoles per mg stool||Standard Deviation|Mean
1279059|NCT00282113|Secondary|Stool Colonization With Bifidobacteria|Using standard culture techniques, we measured how many of the first 11 infants in each arm of the study grew bifidobacteria in their feces after four weeks of treatment.|4 weeks||||Participants|||Number
1279060|NCT00282113|Primary|Weight Gain|Weight at five weeks minus birth weight|5 weeks|Infants left the study as they were discharged from the NICU, therefore many of the infants were not available for measurement at five weeks. The number reported is the number of infants remaining in the study at 5 weeks. Weight in grams is reported.|||Grams||Standard Deviation|Mean
1279061|NCT00282087|Secondary|Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)||2 years||||participants|||Number
1279062|NCT00282087|Secondary|Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)|Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)|2 years||||participants|||Number
1279063|NCT00282087|Secondary|Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)||2 years|Only 38 of the 47 patients were evaluable|||participants|||Number
1279064|NCT00282087|Secondary|Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)||2 years|Only 38 of the 47 patients were evaluable|||participants|||Number
1279065|NCT00282087|Secondary|Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)|Mitotic rate is measured in mitoses per 10 high-power fields|2 years||||mitoses per 10 high-power fields||Full Range|Median
1279071|NCT00282048|Other Pre-specified|Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Overall Survival (OS)|AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. OS is time in weeks from the start of study treatment to date of death due to any cause. Relationship of OS versus AUCss was determined as median OS in participants with high AUCss [AUCss >= median AUCss] or low AUCss [AUCss < median AUCss].|Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both PK and OS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.|||weeks||Full Range|Median
1279072|NCT00282048|Other Pre-specified|Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Progression-free Survival (PFS)|AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. PFS is median time from first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Relationship of PFS versus AUCss was determined as median PFS in participants with high AUCss [AUCss greater than or equal to (>=) median AUCss] or low AUCss [AUCss less than (<) median AUCss].|Day 1 (Pre-dose), Day 29, and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both PK and PFS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.|||weeks||Full Range|Median
1279073|NCT00282048|Other Pre-specified|Correlation of Area Under the Concentration-time Curve at Steady State (AUCss) With Confirmed Partial Response (PR)|AUCss: pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods, computed as each participant’s average total daily dose (accounting for dose reductions and any recorded missed doses) divided by population estimated posthoc individual apparent clearance (CL/F), i.e., AUCss = Daily Dose/(CL/F), where F refers to the oral bioavailability, and CL refers to the systemic clearance. PR: responses with at least 30% decrease in sum of longest dimensions of target lesions using baseline (pre-treatment) sum of longest dimensions as reference. Logistic regression with general linear model was applied to data of PR using AUCss; PR was correlated with AUCss as fold increase in odds of PR with increase in AUCss. Fold increase was calculated as exponent of product of logistic regression slope coefficient and unit change of AUCss.|Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both Pharmacokinetic (PK) and PR data were available were included in analysis.|||Ratio|||Number
1279074|NCT00282048|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)–Kidney Symptom Index (FKSI) Score|FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.|||Units on a Scale||95% Confidence Interval|Mean
1279075|NCT00282048|Secondary|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|||||||
1279076|NCT00282048|Secondary|Functional Assessment of Cancer Therapy (FACT)–Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score|FKSI-DRS is a subset of FKSI which is a questionnaire for FACT –Kidney Symptom Index used to assess Quality of Life (QoL)/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.|Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.|||Units on a Scale||95% Confidence Interval|Mean
1279077|NCT00282048|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the first dose for the last participant|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.|||Days||95% Confidence Interval|Median
1279078|NCT00282048|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks|Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
1279117|NCT00281632|Secondary|Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.|||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
1279079|NCT00282048|Secondary|Progression-free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.|||Days||95% Confidence Interval|Median
1279080|NCT00282048|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.|||Percentage of Participants||95% Confidence Interval|Number
1279081|NCT00281957|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).|Eligible patients who had received any hydroxyurea|||Participants|||Number
1279082|NCT00281957|Secondary|One-year Overall Survival||One year after registration||||Percent of population||95% Confidence Interval|Number
1279083|NCT00281957|Primary|4-month Progression-free Survival|Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.|4 months after registration||||Percent of population||95% Confidence Interval|Number
1279084|NCT00281957|Primary|Response Rate (Complete and Partial)|Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.|Every 8 weeks until progression||||Percent of participants||95% Confidence Interval|Number
1279085|NCT00281918|Secondary|Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)|The time from randomization to the start of a new treatment.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, who started a new CLL treatment.|||Days||95% Confidence Interval|Median
1279086|NCT00281918|Secondary|Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.|Median observation time was approximately 66.4 months|Intent-to-treat population included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1279087|NCT00281918|Secondary|Final Analysis: Duration of Response|Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, all randomized participants, with complete response or partial response who experienced an event (disease progression or death due to any cause).|||Days||95% Confidence Interval|Median
1279088|NCT00281918|Secondary|Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, all randomized participants, with complete response who experienced a disease free survival event (disease relapse or death).|||Days||95% Confidence Interval|Median
1279089|NCT00281918|Secondary|Final Analysis: Time to Event-free Survival Event|Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, with disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death.|||Days||95% Confidence Interval|Median
1279090|NCT00281918|Secondary|Final Analysis: Time to Overall Survival Event|Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants who died.|||Days||95% Confidence Interval|Median
1279091|NCT00281918|Primary|Final Analysis: Time to Progression-free Survival Event|Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, with PFS events.|||Days||95% Confidence Interval|Median
1279092|NCT00281918|Secondary|Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.|||Days to an event|||Number
1279093|NCT00281918|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.|||Days|||Number
1279094|NCT00281918|Secondary|Event-free Survival (EFS)|Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.|||Days||Full Range|Median
1279095|NCT00281918|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.|Median observation time at time of analysis was approximately 21 months|The Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.|||Days||Full Range|Median
1279096|NCT00281879|Primary|Number of Participants With Disease Free Survival (DFS).|"Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of high-risk hematopoietic malignancies.~Disease-free survival: The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer."|Duration of the study; Up to 2 years|||||||
1279097|NCT00281840|Secondary|Response Rate|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|5 years|Patients with evaluable tumors at the end of the study|||participants|||Number
1279098|NCT00281840|Primary|Time to Progression|The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained.|5 yrs after treatment|Patients who received at least one treatment on study|||Months||95% Confidence Interval|Mean
1279099|NCT00281827|Secondary|Number of Patients Alive at 56 Months (End of Study)|Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).|Up to 56 months|Calculated from study entry date to date of death or censored at date of last contact.|||Participants|||Number
1279100|NCT00281827|Secondary|Number of Patients Alive at 2 Years (Survival)|Participants who were alive at 2 years from date of enrollment.|24 Months|Calculated from date of first date of enrollment to date of death.|||Participants|||Number
1279101|NCT00281827|Secondary|Number of Patients Alive at 1 Year (Survival)|Participants who were alive at one year from date of enrollment .|12 Months|Calculated from date of first date of enrollment.|||Participants|||Number
1279102|NCT00281827|Secondary|Number of Patients Disease-free at 2 Years|Calculated from date of enrollment to date of recurrence or death, whichever came first|2 Years||||Participants|||Number
1279103|NCT00281827|Secondary|Number of Patients Disease-free at 1 Year|Calculated from date of enrollment to date of recurrence or death, whichever came first|1 year|Calculated from study entry date to date of recurrence or date of death, whichever came first.|||Participants|||Number
1279104|NCT00281827|Primary|Number of Patients Reporting Clinical Response|Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.|At end of 3 -21 day cycles of treatment|2 of 22 patients did not receive all 3 drugs for all 3 cycles - only 20 patients achieved this and are thereby included here in the evaluable population analysis.|||Participants|||Number
1279105|NCT00281697|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first. Duration of objective response was only analyzed in patients who achieved an objective response.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline and achieved an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
1279106|NCT00281697|Secondary|Objective Response|A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
1279107|NCT00281697|Secondary|One-year Survival|Percentage of patients who survived 1 year in the study.|Baseline to the end of the study (up to 6 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Percentage of patients||95% Confidence Interval|Number
1279108|NCT00281697|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the end of the study (up to 6 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
1279109|NCT00281697|Secondary|Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)|Progression-free survival was defined as the time from randomization to first documented disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. Results are reported for each of the 4 standard chemotherapy cohorts used in the study.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
1279110|NCT00281697|Primary|Progression-free Survival|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
1279111|NCT00281658|Secondary|Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72|The original outcome measure to be analyzed was time to response; however, data are presented as the number of participants with a response at each nominal visit. Responses are based on the investigator’s assessment, and only participants with a confirmed CR or PR were included in this analysis.|Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72|Participants in the ITT Population with a confirmed CR or PR|||participants|||Number
1279112|NCT00281658|Secondary|Duration of Response|Duration of response is defined for the subset of participants with a confirmed CR or PR as the time from first documented evidence of CR or PR until the first documented sign of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause during the randomized phase. Only participants with a confirmed CR or PR were included in this analysis. Disease progression is based on the assessments by the investigator.|Randomization to disease progression or death (up to a maximum of Month 53)|Participants in the ITT Population with a confirmed CR or PR|||months||95% Confidence Interval|Median
1279113|NCT00281658|Secondary|Clinical Benefit|Clinical benefit is defined as the number of participants achieving either a confirmed CR or PR or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions], taking as reference the smallest sum LD since treatment start) of >=24 weeks, based on confirmed responses from the investigator assessment of best overall response during the randomized phase.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population|||participants|||Number
1279114|NCT00281658|Secondary|Overall Response (OR)|OR, evaluated per Response Evaluation Criteria in Solid Tumors (RECIST), is defined as the number of participants achieving either a confirmed complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) of tumor, which were based on confirmed responses from the investigator assessment of best OR during the randomized phase. Participants with unknown or missing responses were treated as non-responders.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population|||participants|||Number
1279115|NCT00281658|Secondary|Progression-free Survival|Progression-free survival is defined as the time from randomization until the earliest date of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause, if sooner during the randomized phase. Disease progression is based on the assessments by the investigator.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population|||months||95% Confidence Interval|Median
1279116|NCT00281658|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|Randomization to death (up to maximum of Month 53)|Intent-to-Treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
1279120|NCT00281632|Secondary|Mean Change From Baseline to Response in Thyroxine|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||nanomoles per liter (nmol/l)||Standard Deviation|Mean
1279121|NCT00281632|Secondary|Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||millimoles per liter (mmol/l)||Standard Deviation|Mean
1279122|NCT00281632|Secondary|Mean Change From Baseline to Response in Total Bilirubin and Creatinine|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||micromoles per liter (umol/l)||Standard Deviation|Mean
1279123|NCT00281632|Secondary|Mean Change From Baseline to Response in Amylase and Lipase|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||Units per liter (U/L)||Standard Deviation|Mean
1279124|NCT00281632|Secondary|Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||International Units per liter (IU/L)||Standard Deviation|Mean
1279125|NCT00281632|Secondary|Mean Change From Baseline to Response in Albumin|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||grams per liter (g/L)||Standard Deviation|Mean
1279126|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate|Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.|Baseline to response (up to 3 years)|All participants|||participants|||Number
1279127|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure|Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.|||participants|||Number
1279128|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure|Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.|||participants|||Number
1279129|NCT00281632|Secondary|Overall Tumor Response|Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.|Baseline to response (up to 3 years)|All participants|||participants|||Number
1279130|NCT00281632|Secondary|Median Progression-free Survival (PFS)|Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.|Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)|All participants with PFS|||days||95% Confidence Interval|Median
1279131|NCT00281632|Secondary|Overall Response and Stable Disease (SD)|Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.|Baseline to response (up to 3 years)|All participants|||percentage of participants|||Number
1279132|NCT00281632|Secondary|CA-125 Doubling Time Prior to and During Treatment With Pazopanib|CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.|Baseline to doubling of CA-125 (up to 3 years)|All participants with confirmed CA-125 50% reduction||||||
1279133|NCT00281632|Secondary|Duration of Biochemical Response (CA-125)|Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.|Baseline to response (up to 3 years)|All participants with confirmed CA-125 50% reduction|||days||95% Confidence Interval|Median
1279134|NCT00281632|Secondary|Time to Biochemical Response (CA-125)|Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.|Baseline to response (up to 3 years)|All participants with confirmed CA-125 50% reduction|||days||Full Range|Median
1279149|NCT00281580|Other Pre-specified|Change From Baseline in Seated Trough Cuff DBP|Observed results for mod-sev patients - key combination therapies|Nominal week over the trial|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Deviation|Mean
1279135|NCT00281632|Primary|Best Biochemical Response (Cancer Antigen [CA-125])|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 >21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir >21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.|Baseline to response (up to 3 years)|All participants|||percentage of participants|||Number
1279136|NCT00281580|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)|Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|8 weeks|Treated set|||percentage of participants|||Number
1279137|NCT00281580|Secondary|Change From Baseline in Seated Trough Pulse Rate|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough pulse rate measurements included all treated patients that had at least one in-clinic pulse rate measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||bpm||Standard Deviation|Mean
1279138|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean SBP|Calculated as seated minus standing for mod-sev patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Deviation|Mean
1279139|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean DBP|Calculated as seated minus standing for mod-sev patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Deviation|Mean
1279140|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean SBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
1279141|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean DBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
1279142|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
1279143|NCT00281580|Secondary|BP Normality|"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough~- key combination therapies"|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||percentage of participants|||Number
1279144|NCT00281580|Secondary|SBP Response|SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||percentage of participants|||Number
1279145|NCT00281580|Other Pre-specified|BP Control|Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||percentage of participants|||Number
1279146|NCT00281580|Secondary|DBP Response|DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||percentage of participants|||Number
1279147|NCT00281580|Secondary|DBP Control|DBP control is defined as DBP < 90 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||percentage of participants|||Number
1279148|NCT00281580|Secondary|Change From Baseline in Standing Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
1279150|NCT00281580|Secondary|Change From Baseline in Standing Trough Cuff Mean DBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
1279151|NCT00281580|Secondary|Change From Baseline in Seated Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
1279152|NCT00281580|Secondary|Change From Baseline in Seated Trough Pulse Rate|Observed results for all patients - key combination therapies|End-of-study visit (LOCF)|The full analysis set relating to the in-clinic trough cuff Pulse Rate measurements included all treated patients that had at least one Pulse Rate measurement following treatment with target therapy (FAS-TC)|||bpm||Standard Deviation|Mean
1279153|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as moderate or severe hypertension at baseline (FAS-TC-MS), excluding patients treated with placebo|||mmHg||Standard Error|Least Squares Mean
1279154|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
1279155|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)|Observed results|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Deviation|Mean
1279156|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
1279157|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)|Observed results|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Deviation|Mean
1279158|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Error|Least Squares Mean
1279159|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Deviation|Mean
1279160|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean SBP|Calculated as seated minus standing for all patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Deviation|Mean
1279161|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean DBP|Calculated as seated minus standing for all patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Deviation|Mean
1279162|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean SBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
1279163|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean DBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
1279165|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
1279166|NCT00281580|Secondary|BP Normality|"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough~- key combination therapies"|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||percentage of participants|||Number
1279167|NCT00281580|Other Pre-specified|BP Control|Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy (FAS-TC).|||percentage of participants|||Number
1279168|NCT00281580|Secondary|SBP Response|SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||percentage of participants|||Number
1279169|NCT00281580|Secondary|DBP Response|DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||percentage of participants|||Number
1279170|NCT00281580|Secondary|DBP Control|DBP control is defined as DBP < 90 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||percentage of participants|||Number
1279171|NCT00281580|Other Pre-specified|Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP|Observed results for key combination therapies|Baseline to nominal week over the trial|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Deviation|Mean
1279172|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Error|Least Squares Mean
1279173|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Error|Least Squares Mean
1279174|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Error|Least Squares Mean
1279175|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC), excluding patients treated with placebo|||mmHg||Standard Error|Least Squares Mean
1279176|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Error|Least Squares Mean
1279177|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)|Observed results|End-of-study visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Deviation|Mean
1279206|NCT00281099|Secondary|All Cause Mortality|Death from any cause|Enrollment to last visit (up to 45 months post-randomization) or death|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||participants who died|||Number
1279178|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Error|Least Squares Mean
1279179|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Deviation|Mean
1279180|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Error|Least Squares Mean
1279181|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Deviation|Mean
1279182|NCT00281528|Secondary|Kaplan Meier Estimate for Progression-Free Survival (PFS)|PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|up to 56 months|Treated population|||months||95% Confidence Interval|Median
1279183|NCT00281528|Primary|The Number of Participants With a Dose Interruption of ABI-007|Number of participants who interrupted (omitted) a dose at some point in the treatment period. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population|||Participants|||Number
1279184|NCT00281528|Primary|The Number of Participants With at Least One Dose Delay for ABI-007|Participants with at least one dose delay for ABI-007. Treatment delays of no longer than 2 weeks allowed participants to recovery from acute toxicity. If treatment was delayed beyond 2 weeks, continuing treatment on protocol was at the physician’s discretion, based upon the best interests of the participant. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population|||Participants|||Number
1279185|NCT00281528|Primary|The Number of Participants With at Least One Dose Reduction for ABI-007|Participants with at least one dose reduction for ABI-007. ABI-007 (Abraxane) dose could be reduced according to protocol guidelines if the participant was experiencing toxicities. Participants were allowed two ABI-007 (Abraxane) dose reductions during the course of the trial. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population|||Participants|||Number
1279186|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) hemoglobin levels were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100g/L; Grade 2 = <100 - 80g/L; Grade 3 = <80 - 65g/L; Grade 4 = <65g/L"|up to 54 months|Treated population who had at least one post baseline value|||participants|||Number
1279187|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) platelet counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L"|up to 54 months|Treated population who had at least one post baseline value|||participants|||Number
1279188|NCT00281528|Primary|Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) WBC counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal -3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L"|up to 54 months|Treated population who had at least one post baseline value|||participants|||Number
1279189|NCT00281528|Secondary|Kaplan Meier Estimate for Participant Survival|Participant survival was summarized using Kaplan-Meier estimate of the time of first dose of study drug to the last known time that the participant was alive. Participants that were alive at the end of follow-up would be censored at the last known time that the patient was alive.|Up to 56 months|Treated population|||Months||95% Confidence Interval|Median
1279190|NCT00281528|Secondary|Kaplan Meier Estimate for Duration of Response|Duration of response was defined as the time from response to the time of disease progression for participants who achieve an objective confirmed complete (CR) or partial overall response (PR). Disease progression is based on the assessments by the investigator. Participants who did not have disease progression following a confirmed complete or partial target response were censored at the last known time that the participant was evaluated for response|Up to 43 months (until progressed)|Treated population who achieved a complete or partial response|||Months||95% Confidence Interval|Median
1279233|NCT00280826|Secondary|Cystoid Macular Edema in the Worse Eye as Assessed by Optical Coherence Tomography (OCT).|Worse eye indicates the eye with the worst visual acuity (VA).|Baseline and 16 weeks|Analysis was per protocol|||microns||Standard Deviation|Mean
1279191|NCT00281528|Secondary|Kaplan Meier Estimate for Time to Disease Progression (TTP)|"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to 43 months (until progressed)|Treated population|||Months||95% Confidence Interval|Median
1279192|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) ANC counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9L; Grade 2 = <1.5 - 1.0*10^9L; Grade 3 = <1.0 - 0.5*10^9L; Grade 4 = <0.5*10^9L"|up to 54 months|Treated population who had at least one post baseline value|||participants|||Number
1279193|NCT00281528|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response (i.e., Total Response) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|"Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), the percentage of participants achieving either~A complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or~A partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions or~Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for progressive disease."|Up to 43 months (until progressed)|Treated population|||Percent of Total Participants|||Number
1279194|NCT00281528|Primary|The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.|Up to 43 months|Treated population|||Percent of Total Participants|||Number
1279195|NCT00281463|Primary|Oxygen Consumption||in-lab visit when propelling on a computer controlled wheelchair dynamometer|PAPAW (.9 m/s, 10 W)|||VO2 (ml/min)||Standard Deviation|Mean
1279196|NCT00281463|Primary|Oxygen Consumption||in-lab visit when propelling on a computer controlled wheelchair dynamometer|personal w/c (.9 m/s, 10 W)|||VO2 (ml/min)||Standard Deviation|Mean
1279197|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12|dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng*h/mL/mg||Standard Deviation|Mean
1279198|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12|AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng*h/mL||Standard Deviation|Mean
1279199|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin|Cmin defined as pre-dose concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1279200|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax|dn-Cmax is defined as dose normalized peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng/mL/mg||Standard Deviation|Mean
1279201|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax|Cmax defined as peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1279202|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax|Tmax defined as time to peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||hours||Full Range|Median
1279203|NCT00281320|Primary|Number of Participants Who Discontinued Because of an Adverse Event|Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).|up to 30 days after study medication stop date|Per protocol|||participants|||Number
1279204|NCT00281320|Primary|Number of Participants Who Experienced an Adverse Event|Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).|Up to Day 42 (treatment period)|Per protocol|||Participants|||Number
1279205|NCT00281099|Secondary|ICD-indicated Patients With Class I Pacemaker Indication.|Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant|Period of time prior to patient consent when considering patient for Implant/Enrollment|Centers kept a screening log, recording for each patient considered for new ICD implant and possible trial enrollment whether the patient had a Class I pacing indication at time of implant. The analysis consisted of descriptive statistics (counts of the 2051 screened patients).|||participants|||Number
1279207|NCT00281099|Secondary|"Quality of Life (QOL) Score"|"Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life(QOL) Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline.~Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best)"|Baseline, 12, 24, and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Units on a scale||Standard Deviation|Mean
1279208|NCT00281099|Secondary|Percent Ventricular Pacing|The percentage of a patients' ventricular beats that were paced by the device.|Enrollment, 6, 12, 24 and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Percent pacing||Standard Deviation|Mean
1279209|NCT00281099|Secondary|"Medication Usage Affecting Heart Rate and Atrioventricular (AV) Conduction"|Whether a subject is on each of a pre-specified set of drugs or classes of drugs.|Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Percentage of Subjects|||Number
1279210|NCT00281099|Secondary|Development of a Pacing Indication During the Study|Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective.|Enrollment to last visit (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||participants|||Number
1279211|NCT00281099|Secondary|Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History|"Persistent AF was defined as any of the following:~2 consecutive visits in which the patient presents with AF~7 consecutive days of at least 22 hours per day of AT/AF~A cardioversion prior to 7 consecutive days of at least 22 hours per day of AT/AF~Clinically Important AF was defined as more than 20 hours of AT/AF in a single day"|Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)|1 of 1031 randomized subjects had a history of at least 6 months of chronic AF, which was an exclusion criterion. Of the remaining 1030 randomized subjects that met all inclusion criteria, only those with no history of AF were included in the analysis (445 in the VVI 40 arm and 444 in the MVP arm). An intention to treat analysis was performed.|||participants|||Number
1279212|NCT00281099|Secondary|"Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes"|Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF|Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Annualized Episodes per Patient Month|||Number
1279213|NCT00281099|Secondary|Composite Mitral Regurgitation (MR) Severity Score|"Echocardiogram measures for this endpoint were obtained at multiple time points. Composite MR Severity was measured on a scale of None to Trivial to Grade IV, with Grade IV being the worst possible score and None to Trivial being the best possible score."|Baseline, 12, and 24 month visits||||participants|||Number
1279214|NCT00281099|Secondary|Left Atrial (LA) and Mitral Regurgitation (MR) Areas|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||centimeters squared (cm2)||Standard Deviation|Mean
1279215|NCT00281099|Secondary|Hemodynamic Deceleration Time|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||milliseconds (ms)||Standard Deviation|Mean
1279216|NCT00281099|Secondary|Hemodynamic Velocity Measures|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||meters per second (m/s)||Standard Deviation|Mean
1279217|NCT00281099|Secondary|Left Ventricular (LV) Sphericity Index|"Echocardiogram measures for each endpoint were obtained at multiple time points.~LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis."|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Ratio||Standard Deviation|Mean
1279275|NCT00280241|Primary|Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL|The number of patients who experience a complete clinical response.|Three months after the sixth cycle (9 months)||||participants|||Number
1279218|NCT00281099|Secondary|Left Ventricular (LV) and Left Atrial (LA) Volumes|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||milliliters (mL)||Standard Deviation|Mean
1279219|NCT00281099|Secondary|Left Ventricular (LV) Ejection Fraction and Fractional Shortening|"Echocardiogram measures for each endpoint were obtained at multiple time points.~LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%.~LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%."|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||percentage of LV unit||Standard Deviation|Mean
1279220|NCT00281099|Secondary|Heart Chamber Dimensions and Wall Thicknesses|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||centimeters (cm)||Standard Deviation|Mean
1279221|NCT00281099|Secondary|Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time|NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.|Baseline, 12, 24 and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||participants|||Number
1279222|NCT00281099|Secondary|Occurrence of Worsening Heart Failure-related Adverse Events|HF event meeting primary endpoint definition, or adverse events associated with, but not limited to, any of the following: symptoms or physical signs compatible with worsening HF, laboratory evidence of HF, any modification of oral heart failure therapy|Enrollment to last visit (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||participants/events|||Number
1279223|NCT00281099|Primary|"All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations."|A composite endpoint of all cause mortality and HF hospitalizations or urgent care. (Emergency Department, Urgent Clinic visits, or hospitalizations wiht intravenous medications for HF)|Enrollment to last visit (up to 45 months post-randomization) or death|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||events|||Number
1279224|NCT00281021|Primary|Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.||Measured every 6 weeks after baseline until disease progression, an average of 3 months||||participants|||Number
1279225|NCT00280917|Secondary|Safety|Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs|12 weeks|||||||
1279226|NCT00280917|Secondary|ACR Criteria Components|ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components [tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR], Disease Activity Score (DAS28), and duration of morning stiffness.|12 weeks|||||||
1279227|NCT00280917|Primary|ACR Efficacy Criteria|ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population|12 weeks||||participants|||Number
1279228|NCT00280904|Primary|Number of Subjects With Shunt Infections|Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.|Implantation to Explant||||participants|||Number
1279229|NCT00280904|Secondary|Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures||April 2008||||participants|||Number
1279230|NCT00280826|Secondary|Change in Visual Acuity in the Better Eye From Baseline to 16 Weeks|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|Baseline and 16 weeks||||ETDRS letters||Standard Deviation|Mean
1279231|NCT00280826|Secondary|Change in Visual Acuity in the Worse Eye From Baseline to 16 Weeks|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|Baseline and 16 weeks|Analysis was per protocol|||ETDRS letters||Standard Deviation|Mean
1279232|NCT00280826|Secondary|Cystoid Macular Edema in the Better Eye as Assessed by Optical Coherence Tomography (OCT).|Better eye indicates the eye with better VA.|Baseline and 16 weeks|Analysis was per protocol|||microns||Standard Deviation|Mean
1279234|NCT00280826|Primary|Number of Participants With Systemic Toxicities, Adverse Events, or Infections|Safety outcomes were recorded by observing and tabulating the nature, severity and frequency of systemic toxicities, adverse events and infections throughout the study. Safety assessments were made by the investigators continuously during the study, with a review of the previous visit interval performed at each scheduled visit. Each participant was also encouraged to report any apparent adverse events between scheduled visits and could return for additional evaluations or treatment between scheduled visits if needed.|16 weeks|Analysis was per protocol|||Participants|||Number
1279235|NCT00280748|Secondary|Response of Patients With Extracranial Disease Treated With Pemetrexed|Response was measured by Response Evaluation Criteria In Solid Tumors RECIST criteria v1.0. Complete Response (CR) - Disappearance of all lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD) – at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing nontarget lesions.|maximum 5 months|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limit sample size. The data represents the results of patients enrolled and treated on the trial.|||Participants|||Count of Participants
1279236|NCT00280748|Secondary|Neurological Function by Mini Mental State Examination|The Mini Mental State Examination is a 30-point questionnaire that is used to measure cognitive impairment. Score totals range from normal cognition (24-30 points), mild impairment (19–23 points), moderate impairment (10–18 points), to severe impairment (≤9 points).|Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment).|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limited sample size. The data represents the results of patients enrolled and treated on the trial.|||score on the scale||Full Range|Mean
1279237|NCT00280748|Secondary|Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification|"A classification score defined as follows:~Able to work or to perform normal activities: neurological findings minor or absent~Able to carry out normal activities with minimal difficulties. Neurological impairment does not require nursing care or hospitalization~Seriously limited in performing normal activities. Requiring nursing care or hospitalization. Patients confined to bed or wheelchair or have significant intellectual impairment~Unable to perform even minimal normal activities. Requiring hospitalization and constant nursing care and feeding. Patients unable to communicate or in coma.A higher score indicates worse function."|At Baseline, 30 days, and at end of treatment (maximum 5 months).|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limit sample size. The data represents the results of patients enrolled and treated on the trial.|||scores on a scale||Full Range|Mean
1279238|NCT00280748|Secondary|Evaluate the Functional Status of Patients Treated With This Regimen.|"Functional status evaluated using the Karnofsky functional status scale. The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. The Karnofsky score runs from 100 to 0, where 100 is perfect health and 0 is death."|baseline functional status only||||Participants|||Count of Participants
1279239|NCT00280748|Secondary|Estimate the Overall Survival of Patients Treated With This Regimen.|Patients were followed for survival from start of treatment until death from any cause (up to 4 years)|4 years|Four patients were unevaluable due to extra-cranial disease progression or decline in performance status preventing re-evaluation.|||months||Full Range|Median
1279240|NCT00280748|Secondary|Number of Subjects Experiencing Adverse Events|"Toxicities was assessed using Common Terminology Criteria for Adverse Events (CTCAE) grading scale. Only toxicities with attribution to chemotherapy of definite or probable are considered, as determined by treating physician."|maximum 5 months|All patients who received treatment were evaluated|||Participants|||Count of Participants
1279241|NCT00280748|Primary|Response of Intracranial Metastases (Complete and Partial Response)|Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|126 days|Of the 10 patients, four patients were unevaluable due to extra-cranial disease progression or decline in performance status prevent re-evaluation.|||Participants|||Count of Participants
1279242|NCT00280735|Secondary|Overall Survival|Overall survival rate at 18 months.|The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months|Participants receiving treatment|||percentage of participants|||Number
1279243|NCT00280735|Secondary|Progression Free Survival|Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.|The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months|Participants receiving treatment|||percentage of participants|||Number
1279244|NCT00280735|Secondary|Toxicity in Patients Treated With This Regimen|Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).|Day 1 of treatment to 30 days after treatment discontinuation|Patients receiving treatment|||percentage of participants|||Number
1279245|NCT00280735|Secondary|Patterns of Recurrence in Patients Treated With This Regimen|Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.|Up to 5 years||||Participants|||Count of Participants
1279246|NCT00280735|Primary|Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen|Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.|12 weeks from initiating adjuvant therapy|Patients assigned to treatment|||Participants|||Count of Participants
1279247|NCT00280683|Secondary|L-arginine Serum Concentration||90 days||||pmol/100ul||Standard Error|Mean
1279248|NCT00280683|Primary|Number of Asthma Exacerbations in Three Months|Asthma exacerbation is a composite endpoint. An asthma exacerbation is defined as any of the following: a) a drop in the morning peak expiratory flow rate (PEF) >30% from baseline on 2 consecutive days, b) a need for initiation of or increased dose of inhaled corticosteroids, or the c) doubling of short-acting rescue β-agonist drug use (e.g.Albuterol) on two consecutive days. Any one of these three counts as one asthma exacerbation.|3 months|Our original power analysis was based on an expected minor exacerbation rate of 3-4 per month.|||exacerbations|||Number
1279249|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1279250|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1279251|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1279252|NCT00280566|Secondary|Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.|Period 2: Weeks 1 - 24 or time of early termination|Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1279253|NCT00280566|Secondary|Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period|Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.|Period 2: Weeks 1 - 24 or time of early termination|Intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1279254|NCT00280566|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.|Period 2: Weeks 1 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1279255|NCT00280566|Secondary|Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period|Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.|Period 2: Weeks 1 - 24 or time of early termination|Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
1279256|NCT00280566|Secondary|Modified Time to Intervention for a Mood Episode (TIME)|Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.|Period 2: Week 24 or time of early termination|Intent to Treat (ITT). 29 out of 127 ziprasidone subjects and 38 out of 111 placebo subjects met the modified criteria for an intervention for a mood episode|||Days||Standard Error|Mean
1279257|NCT00280566|Secondary|Time to Discontinuation for Any Reason During Double Blind Period 2|Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.|Period 2: 24 weeks or time of early termination|Intent to Treat (ITT). Number of participants who discontinued was 43 and 57 for ziprasidone and placebo, respectively.|||days||Standard Error|Mean
1279276|NCT00280241|Secondary|Overall Survival Rate|The percentage of participants who are still alive.|Five years after starting rituximab, cyclophosphamide and fludarabine||||percentage of participants||95% Confidence Interval|Number
1279277|NCT00280241|Primary|Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL|The number of patients who experience any grade 3-5 toxicity.|Duration of treatment on study||||participants|||Number
1283072|NCT00233090|Secondary|Mood|mood|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
1279258|NCT00280566|Primary|Time to Intervention for a Mood Episode During Double Blind Period|Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.|Period 2: 24 weeks or time of early termination|Intent to Treat (ITT):Subjects took at least 1 dose double blind medication and had at least 1 post randomization observation. Double Blind Period followed at least 8 weeks open-label ziprasidone plus mood stabilizer; 25 out of 127 and 36 out of 111 subjects had an intervention for a mood episode.|||Days||Standard Error|Mean
1279259|NCT00280397|Secondary|To Make Exploratory Analyses of Pharmacodynamic Markers||Every 3 weeks|||||||
1279260|NCT00280397|Secondary|Evaluate the Anti-tumor Activity of E7080||Every 3 weeks|||||||
1279261|NCT00280397|Secondary|Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile||Every 3 weeks|||||||
1279262|NCT00280397|Primary|DLT of E7080 Repeatedly Administered Twice a Day|DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.|up to 4 weeks|Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.|||Participants with DLT|||Number
1279263|NCT00280397|Secondary|Number of Participants With Adverse Events / Serious Adverse Events|Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.|Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons.|All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.|||Participants|||Number
1279264|NCT00280397|Primary|Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day|The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.|up to 4 weeks|Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.|||mg BID|||Number
1279265|NCT00280397|Secondary|To Elucidate the Pharmacokinetic Profile of E7080||Every 3 weeks|||||||
1279266|NCT00280384|Primary|Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline).|Baseline||||EDB M-Wave Area at Baseline (mVms)||Standard Deviation|Mean
1279267|NCT00280384|Primary|Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave area reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave area reduction from baseline were presented as a percentage.|Baseline and Up to 12 Weeks||||Percentage of Reduction||Standard Deviation|Mean
1279268|NCT00280384|Primary|Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline).|Baseline||||EDB M-Wave Amplitude at Baseline (mV)||Standard Deviation|Mean
1279269|NCT00280384|Primary|Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave amplitude reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave amplitude reduction from baseline were presented as a percentage.|Baseline and Up to Week 12||||Percentage of Reduction||Standard Deviation|Mean
1279270|NCT00280293|Primary|Positive Urine Drug Screens|Percentage of participants with a positive urine drug screen for cocaine at the week 10 visit or at last assessment if participant withdrew early.|10 weeks||||percentage of participants|||Number
1279271|NCT00280293|Secondary|Dollars Spent|Dollars spent on cocaine during the 7 days of week 10, or at last assessment if participant withdrew early, based on self report.|10 weeks||||Dollars||Standard Deviation|Mean
1279272|NCT00280293|Secondary|Depression Score on the Hamilton Rating Scale For Depression|Total score on the Hamilton Rating Scale for Depression at week 10 visit or at last assessment if participant withdrew early(total score values range 0 - 52. A higher score indicates more severe depression.|10 weeks||||units on a scale||Standard Deviation|Mean
1279273|NCT00280293|Primary|Days of Cocaine Use|Number of days of cocaine use during the 7 days that comprise week 10 of the protocol, by self report, or at last assessment if participant withdrew early, as assessed by the Timeline Followback method.|10 weeks||||days||Standard Deviation|Mean
1279274|NCT00280241|Secondary|Duration of Response|The length of time for which the complete response is maintained.|From complete response to the time of progressive disease, death or last clinical examination||||Months||Full Range|Median
1279278|NCT00280150|Secondary|Feasibility and Tolerability of Administering Consolidation Therapy|The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy|6 cycles|Of the initial 14 patients, only 9 (64%) patients were able to start consolidation therapy and only 5 (36%) patients were able to complete 6 cycles.|||Participants|||Count of Participants
1279279|NCT00280150|Secondary|Overall Response Rate and Survival Profile|The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression.|5 years|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients.|||percentage of participants||95% Confidence Interval|Number
1279280|NCT00280150|Secondary|Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II)|"Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up.~Complete Response (CR)- Disappearance of all target lesions"|5 years|43 of 45 patients received both cycles of induction C/P therapy plus bevacizumab.|||Participants|||Count of Participants
1279281|NCT00280150|Secondary|Progression-free Survival (PFS)|The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients.|||Months||95% Confidence Interval|Median
1279282|NCT00280150|Primary|Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy|A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0).|6 weeks after completion of therapy|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable for toxicity. 42 patients were eligible for concurrent therapy.|||percentage of participants|||Number
1279283|NCT00280150|Primary|Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008])|Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter.|6 weeks after completion of therapy|This was a phase I objective only, so the phase II participants are not included.|||DLTs|||Number
1279284|NCT00280059|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.|Week 8, Week 32, and Week 56|FAS|||participants|||Number
1279285|NCT00280059|Secondary|Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)|Participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items; range: 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of symptoms. Scores relative to start of randomized treatment.|Baseline to Week 56|FAS; N = number of participants with a HADS measurement at baseline and Week 56.|||scores on scale||Standard Error|Least Squares Mean
1279286|NCT00280059|Secondary|Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group|Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.|Week 5 up to Week 56|FAS; N = number of participants with analyzable data.|||percentage of participants|||Number
1279287|NCT00280059|Secondary|Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.|||28-day seizure rate||Standard Deviation|Mean
1279288|NCT00280059|Secondary|Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.|||seizures/28 days||Standard Deviation|Median
1279289|NCT00280059|Secondary|Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.|||28-day seizure rate||Standard Deviation|Mean
1279290|NCT00280059|Secondary|Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.|||seizures/28 days||Standard Deviation|Median
1279291|NCT00280059|Secondary|Mean Monthy Seizure Frequency: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.|||seizures/28 days||Standard Deviation|Mean
1279292|NCT00280059|Secondary|Median Monthy Seizure Frequency: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.|||seizures/28 days||Standard Deviation|Median
1279293|NCT00280059|Secondary|Mean Monthy Seizure Frequency: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.|||seizures/28 days||Standard Deviation|Mean
1279294|NCT00280059|Secondary|Median Monthy Seizure Frequency: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.|||seizures/28 days||Standard Deviation|Median
1279295|NCT00280059|Secondary|Time to First Seizure After the 4-Week Dose Escalation Phase|Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.|||days||95% Confidence Interval|Median
1279296|NCT00280059|Secondary|Exit Due to Any Reason After 4-week Dose Escalation Phase|Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit for any reason after the 4-week dose escalation phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.|||participants|||Number
1279297|NCT00280059|Secondary|Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase|Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to lack of efficacy after 4-week dose escalation phase was inestimable as survival estimate at end of maintenance phase was below 0.500.|||participants|||Number
1279298|NCT00280059|Secondary|Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)|Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.|Week 0 to Week 56|FAS. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data Time to exit for any reason during the double-blind treatment phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.|||participants|||Number
1279309|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
1279299|NCT00280059|Secondary|Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)|Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.|Week 0 to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to adverse events was inestimable as survival estimate at end of maintenance phase was below 0.500.|||participants|||Number
1279300|NCT00280059|Secondary|Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures|Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.|||days||95% Confidence Interval|Median
1279301|NCT00280059|Primary|Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase|Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.|Week 5 up to Week 56|Full analysis set (FAS) (intent to treat population): randomized participants who took at least 1 dose of study medication. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data. Analysis excludes participants who did not enter maintenance phase of study.|||percentage of participants|||Number
1279302|NCT00279955|Secondary|Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)|Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.|6 month to the 12 month visit||||participants|||Number
1279303|NCT00279955|Secondary|Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)|Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.|6 month to the 12 month visit||||participants|||Number
1279304|NCT00279955|Primary|Occurrence of Heart Failure (HF) Related Adverse Event (AE)|Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject’s worsening HF or related to the heart’s inability to meet the metabolic demands of the body.|From 6 month to the 12 month visit|Of the 1001 subjects meeting inclusion and exclusion criteria, 643 subjects had been followed longer than 6 months and had the OptiVolTM feature save-to-disk data available. Those 643 subjects were included in this analysis.|||participants|||Number
1279305|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
1279306|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
1279307|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
1279308|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
1279310|NCT00279916|Secondary|Per-Ear Treatment Outcome|Initial Tympanogram Type at baseline was compared to Follow-Up Tympanogram Type at 6 weeks. Type A is considered to be normal. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.|baseline, 6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.|||ears|||Number
1279311|NCT00279916|Secondary|Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution|For this outcome measure, the subjects treated with antibiotics or oral decongestants while enrolled in the study were handled as having treatment failures. For this outcome measure, subjects with complete normalization of abnormal tympanometry at 6 weeks had a Type A tympanogram and did not take antibiotics, oral decongestants, nasal spray or a combination.|6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.|||participants|||Number
1279312|NCT00279916|Primary|Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment|Number of subjects with resolution of eustachian tube dysfunction symptoms, as determined by the change in tympanogram type in both ears from an initial Type B or C result to Type A result at 6 weeks. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.|6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.|||participants|||Number
1279313|NCT00279812|Secondary|Selenoproteins and Se-biomarkers|Plasma selenoprotein P after the supllementation|10 weeks|Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject|||ug/mL||Standard Deviation|Mean
1279314|NCT00279812|Secondary|Selenium Status|Plasma selenium concentration after supplementation|10 weeks|Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject|||ng/mL||Standard Deviation|Mean
1279315|NCT00279812|Primary|Cellular and Humoral Immune Response|Total glutathione peroxidase 1 activity in platelets after supplementation|12 weeks|Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject|||umol/min||Standard Deviation|Mean
1279316|NCT00279708|Other Pre-specified|Chest Imaging|HRCT Chest radiographs|12 month treatment period||2018-09-30|09/2018||||
1279317|NCT00279708|Secondary|Quality of Life and Dyspnea Scales|St. George's Respiratory Questionnaire SF-36 Modified MRC Dyspnea Scale|12 month treatment period||2017-09-30|09/2017||||
1279318|NCT00279708|Secondary|Exercise Performance|Cardiopulmonary Exercise Tests (VO2 peak, VO2/work, VECO2) Six minute Walk Test (distance, Borg scale)|12 month treatment period||2017-09-30|09/2017||||
1279319|NCT00279708|Secondary|Pulmonary Function Tests|Spirometry measurements (FVC and FEV1) obtained post-bronchodilator Diffusion, adjusted for hemoglobin|12 month treatment period||2017-09-30|09/2017||||
1279320|NCT00279708|Secondary|Pulmonary Sarcoidosis Flares|Flare rates and relative risk: Flares (relapses) were defined as the physiological deterioration in pulmonary function due to worsened pulmonary inflammation. The criteria used for a pulmonary flare included: > 15% decline in static function (FEV1 post, FVC post); or (> 20% DLCO adj); or a > 15% decline in walk distance as measured by the six minute walk test, or via a decline in oxygen consumption collected during a cardiopulmonary exercise test (CPET). Additional factors considered included an increase in dyspnea (>15% increase in the dyspnea scale (TDI); and/or significant radiographic worsening. Clinical assessment of the patient’s status may have been factored into the criteria for flare determination as well.|1 year||2017-09-30|09/2017||||
1279321|NCT00279708|Primary|The Steroid Sparing Period|The duration of steroid sparing was defined as the date when the target dose of prednisone was reached until the date at which the dose was increased and/or met the relapse (flare) criteria; or until the 12 month study phase ended if no prednisone dose increase was required. The steroid sparing period was measured in units of days. The prednisone target dose was defined as a 90% reduction of the baseline dose or an absolute prednisone dose of 4 mg/day or less.|1 year||||days||Inter-Quartile Range|Mean
1279322|NCT00279591|Secondary|Amount of Intravenous Fluid Resuscitation||At start of inter-facility transport, then every 15 minutes until arrival.||||ml/kg||Standard Deviation|Mean
1279323|NCT00279591|Secondary|Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.|The Therapeutic Intervention Scoring System (TISS-28) is an illness severity score for the ICU. The TISS score can range from zero up to 78. The higher the score is, the more severe the illness. The TISS-28 scale measures the severity of a patient's illness.|Up to two weeks|This is the total number of participants analyzed for the intervention group and the control group and the total number of days analyzed overall for the intervention group and the control group.|||units on a scale|Participants|Standard Deviation|Mean
1279324|NCT00279591|Secondary|Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure.|Total number of organ failure days is for each group as a whole.|Up to two weeks|ITT|||Days|Participants||Number
1279325|NCT00279591|Secondary|Intensive Care Unit (ICU) Length of Stay||Up to two weeks||||days||Standard Deviation|Mean
1279326|NCT00279591|Primary|The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care|This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall.|Up to two weeks|Intention to Treat|||days||Standard Deviation|Mean
1279327|NCT00279500|Primary|Number of Adverse Events From 2 Weeks Post-op Until the End of the Study|All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.|From 2 weeks post-op until end of device usage, up to 10 years.||||total number of AEs|||Number
1279328|NCT00279305|Primary|Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year|"The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.~The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."|When all participants complete the 1 year visit||||pmol per mL||95% Confidence Interval|Mean
1279329|NCT00279214|Secondary|Mixed Venous Oxygen Saturation|Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.|Baseline to 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.|||percent saturation mixed venous oxygen||Standard Deviation|Mean
1279330|NCT00279214|Other Pre-specified|Number of Participants With Bleeding Events|Serious bleeding event resulted in one of following outcomes, or was significant for any reason: initial/ prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly/birth defect. Intracranial hemorrhage was also considered serious bleeding event.|baseline to 7 days|All enrolled patients|||participants|||Number
1279331|NCT00279214|Secondary|Endogenous Protein C Level||Baseline to 24 Hours|Number of per-protocol participants with values at baseline, 12, and 24 hours.|||percentage of Protein C activity||Standard Deviation|Mean
1279332|NCT00279214|Secondary|7 Day All-cause In-hospital Mortality||baseline to 7 days|All enrolled patients|||partipants|||Number
1279333|NCT00279214|Secondary|Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours|CrCl = (urine creatinine*urine volume)/(plasma creatinine*time period of urine collection). Corrected CrCl = CrCl*1.73/body surface area. Change in CrCl = Endpoint minus baseline.|Baseline and 24 hours|Number of per-protocol participants with values at baseline and 24 hours.|||milliliter per minute||Standard Deviation|Mean
1279334|NCT00279214|Secondary|Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours|The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction).|Baseline and 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.|||units on a scale||Standard Deviation|Mean
1279335|NCT00279214|Secondary|Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)|Per vessel category (and per quadrant), scored flow as follows: no flow=0, intermediate flow=1, sluggish flow=2, continuous flow=3. The MFI per vessel category calculated with formula (Q1+Q2+Q3+Q4)/4. Scores could range from 0 (sluggish flow) to 3 (continuous flow).|Baseline to 24 Hours|Number of per-protocol participants with values at baseline, 12, and 24 hours.|||units on a scale||Standard Deviation|Mean
1279336|NCT00279214|Secondary|Lactate Level|Measures of global tissue perfusion and oxygenation were assessed via lactate levels.|Baseline to 6 Hours|Number of per-protocol participants with values at baseline and 6 hours.|||millimoles per Liter||Standard Deviation|Mean
1279337|NCT00279214|Secondary|Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index|Cardiac Index = cardiac output divided by body surface area.|Baseline to 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.|||liters/minute/meters squared||Standard Deviation|Mean
1279338|NCT00279214|Secondary|Mean Arterial Pressure||baseline to 24 hours|Number of per-protocol participants with values at baseline and 24 hours.|||mm Hg||Standard Deviation|Mean
1279339|NCT00279214|Secondary|Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)|CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.|Baseline, 96 hours|Number of per-protocol participants with values at baseline and 96 hours.|||units on a scale||Standard Deviation|Mean
1279340|NCT00279214|Primary|Cumulative Vasopressor Index (CVI)|CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.|baseline to 24 hours|Number of per-protocol participants with values at baseline and 24 hours.|||units on a scale||Standard Deviation|Mean
1279341|NCT00279201|Secondary|ADDENDUM: HbA1c at Specified Visits and Endpoint||Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279342|NCT00279201|Secondary|ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24||Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||ug/mL||Standard Deviation|Mean
1279343|NCT00279201|Secondary|ADDENDUM: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||episodes/participant/year||Standard Deviation|Mean
1279366|NCT00279201|Secondary|MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol||Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||ug/dL||Standard Deviation|Mean
1279344|NCT00279201|Secondary|ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||percentage of participants|||Number
1279345|NCT00279201|Secondary|ADDENDUM: Insulin Dose||Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||units/kg/day||Standard Deviation|Mean
1279346|NCT00279201|Secondary|ADDENDUM: Body Weight||Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||kilograms||Standard Deviation|Mean
1279347|NCT00279201|Secondary|ADDENDUM: Incremental Change From Baseline in Body Weight||Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||kilograms||Standard Deviation|Mean
1279348|NCT00279201|Secondary|ADDENDUM: 7-point SMPG Profiles|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Endpoint (Addendum: 24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||mg/dL||Standard Deviation|Mean
1279349|NCT00279201|Secondary|ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%||Endpoint (Addendum: 24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||percent of participants|||Number
1279350|NCT00279201|Secondary|ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint||Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||percent||Standard Deviation|Mean
1279351|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose|Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||mg/dL||Standard Deviation|Mean
1279352|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose|Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||mg/dL||Standard Deviation|Mean
1279353|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG|Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||ug/ml||Standard Deviation|Mean
1279354|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG|Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||ug/mL||Standard Deviation|Mean
1279355|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline|Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
1283073|NCT00233090|Secondary|Cognitive Performance|Cognitive performance|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
1279356|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline|Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
1279357|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group|Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
1279358|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group|Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
1279359|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c|Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279360|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c|Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279361|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group|Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
1279362|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group|Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
1279363|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes|Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||years||Standard Deviation|Mean
1279364|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes|Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||years||Standard Deviation|Mean
1279365|NCT00279201|Secondary|MAINTENANCE: Change From Baseline to Endpoint in HbA1c||Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279444|NCT00278876|Secondary|Toxicity Profile|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of adjuvant imatinib|Monitoring of adverse events will be continued for at least 28days following the last dose of study treatment, up to 3 years.||||participants|||Number
1279367|NCT00279201|Secondary|MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||episodes/participant/year||Standard Deviation|Mean
1279368|NCT00279201|Secondary|MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percentage of participants|||Number
1279369|NCT00279201|Secondary|MAINTENANCE: Insulin Dose||Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||units/kg/day||Standard Deviation|Mean
1279370|NCT00279201|Secondary|MAINTENANCE: Body Weight||Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||kilograms||Standard Deviation|Mean
1279371|NCT00279201|Secondary|MAINTENANCE: Incremental Change From Baseline in Body Weight||Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||kilograms||Standard Deviation|Mean
1279372|NCT00279201|Secondary|MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%||Endpoint (LOCF) (Maintenance: up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percentage of participants|||Number
1279373|NCT00279201|Secondary|MAINTENANCE: Rate of Increase in HbA1c|Rate of increase: HbA1c change/time period (month).|Endpoint (LOCF) (Maintenance: up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||HbA1c percent increase per month||Standard Deviation|Mean
1279374|NCT00279201|Secondary|MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||mg/dL||Standard Deviation|Mean
1279375|NCT00279201|Secondary|MAINTENANCE: HbA1c at Specified Visits and Endpoint||Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279376|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline|Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||participants|||Number
1279377|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose|Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1279378|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG|Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
1279379|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group|Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||participants|||Number
1279445|NCT00278876|Secondary|2-year Overall Survival Rate||2 years||||percentage of participants|||Number
1279446|NCT00278876|Primary|2-year Relapse Free Survival Rate||2 years||||percentage of participants|||Number
1279380|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c|Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279381|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||units on a scale||Standard Deviation|Mean
1279382|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin|Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||participants|||Number
1279383|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age|Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||years||Standard Deviation|Mean
1279384|NCT00279201|Secondary|INITIATION: Insulin Dose||Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||units/kg/day||Standard Deviation|Mean
1279385|NCT00279201|Secondary|INITIATION: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||Episodes/participant/year||Standard Deviation|Mean
1279386|NCT00279201|Secondary|INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percentage of participants|||Number
1279387|NCT00279201|Secondary|INITIATION: Body Weight||Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||kilograms||Standard Deviation|Mean
1279388|NCT00279201|Secondary|INITIATION: Incremental Change From Baseline in Body Weight||Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||kilograms (kg)||Standard Deviation|Mean
1279389|NCT00279201|Secondary|INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)||Baseline (Initiation), Endpoint (Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
1279390|NCT00279201|Secondary|INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Endpoint (LOCF) (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||milligrams per 100 Milliliters (mg/dL)||Standard Deviation|Mean
1279391|NCT00279201|Secondary|INITIATION: HbA1c||Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279392|NCT00279201|Secondary|INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint||Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percentage of participants|||Number
1279393|NCT00279201|Secondary|INITIATION: Change in HbA1c From Baseline to 24 Weeks||Baseline (Initiation) to Endpoint (LOCF, Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279447|NCT00278863|Secondary|Number of Patients With Adverse Events|Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years|Up to 2 years||||participants|||Number
1279394|NCT00279201|Primary|ADDENDUM: 24-Week Endpoint HbA1c|HbA1c at 24-week endpoint in Intensification Addendum of the trial.|Endpoint (Addendum) (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: Week 24: 48 weeks.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279395|NCT00279201|Primary|MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)|HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%|Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)|Last observation carried forward method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||months||95% Confidence Interval|Median
1279396|NCT00279201|Primary|INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)||Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment in the initiation phase. Initiation baseline: Week 0.|||percent glycosylated hemoglobin||Standard Deviation|Mean
1279397|NCT00278993|Secondary|Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|12 months|Per Protocol Population|||Percentage of Participants|||Number
1279398|NCT00278993|Secondary|Overall Survival||12 months|Intent to Treat Population|||Days||Full Range|Median
1279399|NCT00278993|Secondary|Progression Free Survival|From the date study treatment was initiated until the earliest date of the first PSA assessment that determined progressive disease, or the death of death if death occurred without disease progression.|12 months|Per Protocol Population|||Days||Full Range|Median
1279400|NCT00278993|Secondary|Duration of Prostate Specific Antigen Response Based on Bubley Criteria|Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir.|12 months.|Per Protocol Population|||Days||Full Range|Median
1279401|NCT00278993|Primary|Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria|Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.|12 months|Per Protocol Population|||Percentage of Participants|||Number
1279402|NCT00278954|Secondary|The Pharmacokinetic (PK) Mean Residence Time (MRT) for Inmuunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days||||Days||Standard Deviation|Mean
1279403|NCT00278954|Secondary|The Pharmacokinetic (PK) Volume of Distribution (Vz)of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.|||dL/kg||Standard Deviation|Mean
1279404|NCT00278954|Secondary|The Pharmacokinetic (PK) Clearance of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.|||mL/day/kg||Standard Deviation|Mean
1279405|NCT00278954|Secondary|The Pharmacokinetic (PK) Half-Life of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.|||Days||Standard Deviation|Mean
1279406|NCT00278954|Primary|Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease.|By assessing the number of serious, acute, bacterial infections per subject per year in subjects with Primary Immunodeficiency disease.|12 months|Intent to Treat (ITT).|||SABIs/subject/year|||Number
1279407|NCT00278915|Secondary|Percentage of Patients With Gsα Mutation.|McCune-Albright Syndrome(MAS) is caused by an activating mutation in the gene coding for the stimulatory subunit of the G protein, Gsα. The altered Gsα causes autonomous activation of G-protein stimulated cAMP formation, which in the gonads, results in episodic uncontrolled sex steroid production and subsequent pubertal development. For patients who provided separate specific informed consent, the percentage of patients with a Gsα mutation at screening was assessed by molecular analysis.|Screening assessment (baseline)||||Percentage of participants|||Number
1279408|NCT00278915|Secondary|Change in Predicted Adult Height (PAH) From Baseline to Month 12.|Change in PAH from baseline to Month 12/final visit for patients equal to or over 6 years of age.|6 month pre-treatment observation period (result at Screening considered as baseline) followed by 12 month treatment period (on treatment period).||||cm||Standard Deviation|Mean
1279409|NCT00278915|Secondary|Change in Pubic Tanner Stage From Baseline to Month 12.|Change in pubic Tanner stage from baseline to Month 12/last visit. Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair|6 month pre-treatment observation period (result at Month 0 considered as baseline) followed by 12 month treatment period (on treatment period).||||units on a scale||Full Range|Median
1279465|NCT00278343|Secondary|Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0||Up to 4 years|Data were not collected.||||||
1279410|NCT00278915|Secondary|Change in Breast Tanner Stage From Baseline to Month 12.|Change in breast Tanner stage from baseline to Month 12/last visit. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast|6 month pre-treatment observation period (result at Month 0 considered as baseline) followed by 12 month treatment period (on treatment period).||||units on a scale||Full Range|Median
1279411|NCT00278915|Secondary|PK: Mean Volume of Distribution (V2/F) .|Total apparent volume of distribution (Vss/F) is the total apparent volume in the body into which Fulvestrant distributes at equilibrium. Vss/F = V1/F + V2/F. V1/F is the volume of the 1st compartment and V2/F is the volume of the second compartment. V2/F only is presented here. The measure of variability presented is the inter-individual error.|Throughout the 12 month treatment period.||||Litres||Standard Error|Mean
1279412|NCT00278915|Secondary|PK: Mean Volume of Distribution (V1/F)|Total apparent volume of distribution (Vss/F) is the total apparent volume in the body into which Fulvestrant distributes at equilibrium. Vss/F = V1/F + V2/F. V1/F is the volume of the 1st compartment and V2/F is the volume of the second compartment. V1/F only is presented here. The measure of variability presented is the inter-individual error.|Throughout the 12 month treatment period.||||Litres||Standard Error|Mean
1279413|NCT00278915|Secondary|PK: Mean Clearance.|Mean clearance is the average amount of Fulvestrant which is eliminated|Throughout the 12 month treatment period.||||Litres/hour||Standard Deviation|Mean
1279414|NCT00278915|Secondary|Hormone Assays: Testosterone.|Hormone assays: testosterone at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period..|Month 12 of the treatment period.||||nmol/Litres||Standard Deviation|Mean
1279415|NCT00278915|Secondary|Hormone Assays: Follicle-stimulating Hormone (FSH).|Hormone assays: follicle-stimulating hormone (FSH)at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period..|Month 12 of the treatment period.||||IU/Litres||Standard Deviation|Mean
1279416|NCT00278915|Secondary|Hormone Assays: Luteinizing Hormone (LH).|Hormone assays: Luteinizing hormone (LH) at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period.|Month 12 of the treatment period.||||IU/Litres||Standard Deviation|Mean
1279417|NCT00278915|Secondary|Hormone Assays: Serum Oestradiol.|Hormone assays: serum oestradiol at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period.|Month 12 of the treatment period.||||pmol/Litres||Standard Deviation|Mean
1279418|NCT00278915|Secondary|Change in Ovarian Volume From Month 6 to Month 12 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.||||cm^3||Full Range|Median
1279419|NCT00278915|Secondary|Change in Ovarian Volume From Baseline to Month 6 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.||||cm^3||Full Range|Median
1279420|NCT00278915|Secondary|Change in Ovarian Volume From Baseline to Month 12 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.||||cm^3||Full Range|Median
1279421|NCT00278915|Secondary|Change in Uterine Volume From Month 6 to Month 12 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Month 6 and Month 12 during the treatment period.||||cm^3||Full Range|Median
1279422|NCT00278915|Secondary|Change in Uterine Volume From Baseline to Month 6 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Screening visit (baseline) and Month 6 during the treatment period.||||cm^3||Full Range|Median
1279423|NCT00278915|Secondary|Change in Uterine Volume From Baseline to Month 12 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Screening visit (baseline) and Month 12 during the treatment period.||||cm^3||Full Range|Median
1279424|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the Whole 12 Month Trial Period.|Change in growth velocity (Z-Score) from pre-treatment to the full 12 month treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||Z-Score||Standard Deviation|Mean
1279425|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the Second 6 Month Trial Period.|Change in growth velocity (Z-Score) from pre-treatment to the second 6 months of the treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||Z-score||Standard Deviation|Mean
1279426|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the First 6 Month Trial Period.|Change from pre-treatment period to the first 6 months of the treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 6 month treatment period (on treatment period)||||Z-Score||Standard Deviation|Mean
1279427|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Whole 12 Month Trial Period.|Change in growth velocity (annualised growth velocity i.e. cm/y) from the pre treatment period to the full 12 month treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||cm/year||Standard Deviation|Mean
1279466|NCT00278343|Secondary|Duration of Overall CA-125 Response|Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by > 50%.|Up to 4 years|"1 confirmed PR observed in PS group. Response will be defined as reduction in level of pre-treatment sample by > 50%.~0 confirmed PR observed in PR group."|||weeks|||Number
1279428|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Second 6 Month Trial Period.|Change in growth velocity (annualised growth velocity i.e. cm/y) from the pre treatment period to the second 6 months of the treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||cm/year||Standard Deviation|Mean
1279429|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the First 6 Month Trial Period.|Change in growth velocity (annualised growth velocity.i.e. cm/y) from the pre treatment period to the first 6 months of the treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 6 month treatment period (on treatment period)||||cm/year||Standard Deviation|Mean
1279430|NCT00278915|Secondary|Change in Bone Age Advancement Over the Whole 12 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the full 12 month treatment period. (Using last value carried forward method for the one patient who withdrew soon after their month 6 bone scan) Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||cm/year||Standard Deviation|Mean
1279431|NCT00278915|Secondary|Change in Bone Age Advancement Over the Second 6 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the second 6 months of the treatment period. Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|baseline to second 6 months of the treatment period.||||cm/year||Standard Deviation|Mean
1279432|NCT00278915|Secondary|Change in Bone Age Advancement Over the First 6 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the first 6 months of the treatment period. Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|baseline to first 6 months of the treatment period||||cm/year||Standard Deviation|Mean
1279433|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding .|Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding for the full 12 month treatment period, based on a worst-case approach i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||Percentage of Participants|||Number
1279434|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6 Month Trial Period.|Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding for at least 180 consecutive days during the 12 month treatment period, based on a worst-case approach i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|This particular protocolled endpoint does not relate to all patients but only those who had baseline vaginal bleeding - N=23 rather than N=30.|||Percentage of Participants|||Number
1279435|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥50% Reduction in the Number of Vaginal Bleeding Days|Percentage of participants with baseline vaginal bleeding who experienced ≥50% reduction in the number of vaginal bleeding days during the 12 month treatment period compared to the 6 month baseline period.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|Number of participants (23) = number of eligible participants who have had bleeding during the 6 month baseline period|||Percentage of Participants|||Number
1279436|NCT00278915|Primary|Change in the Frequency of Annualised Days of Vaginal Bleeding|Change in the frequency of annualised days of vaginal bleeding during the 12 month treatment period compared to the 6 month baseline period, based on a worst-case scenario calculation .i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||days per year||Full Range|Median
1279437|NCT00278889|Secondary|QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)|Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007||||Days||Inter-Quartile Range|Median
1279438|NCT00278889|Secondary|QOL: Time to Worsening of Clear Cell Sarcoma (CCS)|Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007||||Days||Inter-Quartile Range|Median
1279439|NCT00278889|Secondary|QOL: Time to Worsening of Treatment-free Survival (TFS)|Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires|Randomisation to data cut-off date of November 2007||||Days||Inter-Quartile Range|Median
1279440|NCT00278889|Secondary|Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)|Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007||||Days||Inter-Quartile Range|Median
1279441|NCT00278889|Secondary|Overall Survival|Number of months from randomisation to the date of death from any cause|Randomisation to data cut-off date of 30 January 2009||||Months||Inter-Quartile Range|Median
1279442|NCT00278889|Secondary|Objective Response Rate|"Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST."|Randomisation to data cut-off date of November 2007||||Participants|||Number
1279443|NCT00278889|Primary|Progression Free Survival|Number of months from randomisation to the earlier date of objective progression or death|Randomisation to data cut-off date of November 2007||||Months||Inter-Quartile Range|Median
1279448|NCT00278863|Primary|Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD~Response rate is defined as the proportion of patients who showed OR."|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
1279449|NCT00278655|Secondary|Survival|"Data are reporting the number of participants who survived three years after the transplant~Survival of 21 participants was evaluated at three years after the transplant"|three years||||participants|||Number
1279450|NCT00278655|Primary|Disease Progression|Data are reporting number of participants with disease progression. Disease progression is defined as a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least 3 months apart.|3 years after transplant||||participants|||Number
1279451|NCT00278564|Primary|Survival|Survival|up to 5 years|All participants who underwent stem cell transplantation|||Participants|||Count of Participants
1279452|NCT00278525|Primary|Disease Improvement|"Data are reporting number of participants that were classified as disease improvement.~Definition of disease improvement:~Disease improvement defined by at least 25% improvement in skin score (Rodnan), or 10% improvement in pulmonary function tests [diffusing capacity of the lung for carbon monoxide (DLCO), diffusing capacity divided by the alveolar volume (DLCO/VA), or forced vital capacity (FVC)], or in cardiac tests [pulmonary artery (PA) systolic pressure by right heart cath] that persists > 6 months or ability to wean off total parenteral nutrition (TPN)"|12 months||||participants|||Number
1279453|NCT00278525|Primary|Time to Treatment Failure|"-Data are reporting number of participants that were classified as treatment failures~Time to Treatment Failure Definition-Treatment failure will not occur until a minimum of 12 months after enrollment at which time failure is defined as:~Failure of skin score (if > 14 on enrollment) to improve or increase in skin score by a 25% above lowest post treatment value and must be documented on 2 occasion 6 months apart~Deterioration in diffusing capacity of the lung for carbon monoxide (DLCO), diffusing capacity divided by the alveolar volume (DLCO/VA) or forced vital capacity (FVC) by 10% below enrollment level or 10% below best post treatment value, due to systemic sclerosis, and documented on 2 occasion 6 months apart~Renal failure due to systemic sclerosis and defined as chronic dialysis for more than 12 months~Gastrointestinal failure due to systemic sclerosis and defined as initiation of total parenteral nutrition(TPN) for more than 12 months"|12 months|All participants were included|||participants|||Number
1279454|NCT00278512|Primary|Survival|Survival|Up to 5 years||||Participants|||Count of Participants
1279455|NCT00278473|Secondary|Rosenberg Self-Esteem Inventory|Mean change in Rosenberg Self-Esteem Inventory score at 12 weeks as compared to baseline. The scale is a ten item Likert scale, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.|baseline and at 12 weeks||||units on a scale||Standard Deviation|Mean
1279456|NCT00278473|Secondary|Hamilton Anxiety Rating Scale|Mean Change in Hamilton Anxiety Rating Scale at 12 weeks as compared to baseline. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.|baseline and at 12 weeks||||units on a scale||Standard Deviation|Mean
1279457|NCT00278473|Secondary|Beck Depression Inventory|"Mean change in the Beck Depression Inventory Scale at 12 weeks as compared to baseline.~The Beck Depression Inventory, 2nd edition to assess Depression symptoms. BDI-II scores range between 0 and 63, with categorical depression ratings of “minimal” (0–13), “mild” (14–19), “moderate” (20–28), and “severe” (29–63)."|baseline and at 12 weeks||||units on a scale||Standard Deviation|Mean
1279458|NCT00278473|Secondary|CAARS-O:L|Change in the Conners Adult ADHD Rating Scales–Observer: Long Version (CAARS-O:L), inattention/memory subscale at 12 weeks as compared to baseline. 12 items subscale. T-score of at least 63 gives risk or possible diagnosis of ADHD. This number, lower or higher, does not indicate severity.|baseline and at 12 weeks||||T-score||Standard Deviation|Mean
1279459|NCT00278473|Primary|Time Management, Organization, and Planning Subscale|"Time management, organization, and planning subscale at posttreatment at 12 weeks as compared to baseline.~The mean difference On Time Management Organization and Planning scale which is a 24-item self-report questionnaire that uses a 7-point Likert-type scale ranging from –3 (far below average) to +3 (far above average) and subsequently totaled to obtain a composite index of proficiency (possible scores range from –102 to +102), which was developed and previously used at the ADHD program at the Icahn School of Medicine at Mount Sinai."|baseline and at 12 weeks||||units on a scale||Standard Deviation|Mean
1279460|NCT00278473|Primary|Inattention Subscale|Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Inattention subscale. Mean change score at 12 weeks as compared to baseline. Each item is scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe); the maximum total score with 27 points being the most severe.|12 weeks||||units on a scale||Standard Deviation|Mean
1279461|NCT00278395|Secondary|Safety and Tolerability||1 year|Data were not collected||||||
1279462|NCT00278395|Secondary|Overall Survival (OS) and Median OS||1 year|Data were not collected||||||
1279463|NCT00278395|Secondary|Progression-free Survival||1 year|Data were not collected||||||
1279464|NCT00278395|Primary|Objective Response|"Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria.~Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1 year|The overall duration of response will be estimated using the Kaplan-Meier method for all patients who presented with an objective response.|||participants|||Number
1279467|NCT00278343|Secondary|Progression-free Survival (PFS)|The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.|Time from start of treatment to time of progression, assessed up to 6 months||||months||95% Confidence Interval|Median
1279468|NCT00278343|Secondary|Overall Survival (OS) (Discontinued as of 4/25/2014)|The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months.||||months||95% Confidence Interval|Median
1279469|NCT00278343|Secondary|Time to Disease Progression|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 4 years|Platinum sensitive cohort|||months||95% Confidence Interval|Median
1279470|NCT00278343|Primary|Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR+PR|After 16 weeks|Total # of Patients 74 PL-S (platinum sensitive) 39 patients PL-R (platinum resistant) 35 patients Confirmed PR PL-S group 9/39 patients Confirmed PR PL-R group 0/35 patients|||participants|||Number
1279471|NCT00278161|Primary|Event-free Survival|Percentage of participants alive without disease relapse.|5 years|Participants were split into two populations for this outcome only: mantle-cell lymphoma and other low-grade B-cell tumors.|||percentage of participants|||Number
1279472|NCT00278161|Primary|Non-relapse Mortality|Number of participants who died for reasons related to protocol treatment.|5 years||||Participants|||Count of Participants
1279473|NCT00278161|Primary|Engraftment|Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count >= 500 cells per microliter; platelet recovery is defined as untransfused platelet count >= 20 * 10^9 cells per liter.|Up to 43 days||||days||Full Range|Median
1279474|NCT00277524|Primary|ICD/CRT-D Device Baseline Programming Measurements|"ICD/CRT-D baseline programming measurements, detection interval. Implanted Cardioverter/Defibrillator paces a patient's heart in a tachyarrhythmia prevention-pacing mode.~Detection intervals are used to detect atrial tachyarrhythmia. Detection Intervals are programmable heart rate thresholds. R-R intervals that are less than the VT or VF detection intervals (in ms) are considered evidence of VT or VF, respectively. R-R intervals that are between the FVT and the VF detection intervals are considered evidence of FVT. Thus, these detection interval thresholds demarcate rate zones of detection. The rate zones are used to determine the type of therapy applied once detection occurs."|Baseline||||ms||Standard Deviation|Mean
1279475|NCT00277524|Secondary|Frequencies of Subjects With OptiVol Trends and Disease Progression.|"Estimate the correlation between OptiVol trends and disease progression.~A subject’s disease status was said to have progressed if:~The NYHA classification number increases (example: I to II), or~The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or~The subject expires~A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'."|4 years post implant||||participants|||Number
1279476|NCT00277524|Secondary|"Compare First Shock Rate Between Medtronic PainFREE Programming and SCD-HeFT Programming in Primary Prevention Study Participants."|"First shock rate for VF and FVT zones was estimated using Kaplan-Meier method.~OMNI “PainFREE” definition: programming combinations that result in ATP therapy for ventricular tachycardia (VT) at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.~OMNI “SCD-HeFT” definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms."|4 years post implant||||rate||Standard Deviation|Mean
1279477|NCT00277524|Secondary|Summary of ATP Episodes Within All Treated Episodes|Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.|4 years post enrollment||||Episodes|||Number
1279478|NCT00277524|Secondary|AV Block Status by Severity of Historical AV Block|Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block|4 years post implant||||participants|||Number
1279479|NCT00277524|Secondary|AV Block Status by Device Type at 6 and 12 Months.|Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.|12 months post enrollment||||participants|||Number
1279480|NCT00277524|Primary|ICD/CRT-D Device Baseline Programming Frequencies|ICD/CRT-D baseline programming, pacing mode and detection. Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.|Baseline||||participants|Participants||Number
1279505|NCT00277212|Secondary|Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)|Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.|||Proportion of Participants|||Number
1279481|NCT00277524|Primary|Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.|Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.|Baseline||||participants|||Number
1279482|NCT00277524|Primary|Implanted Systems Frequencies|Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).|Baseline||||participants|||Number
1279483|NCT00277446|Secondary|Forced Expiratory Volume in One Second (FEV1)|Forced expiratory volume in one second (FEV1) measured as liters/second|0 and 4 weeks||||liters/sec||Standard Deviation|Mean
1279484|NCT00277446|Secondary|Eosinophil LTC4 Synthesis|Peripheral blood eosinophils were isolated before and after treatment with Novasoy, stimulated with calcium ionophore, and the amount of leukotriene C4 (LTC4) produced was measured by EIA.|0 and 4 weeks||||ng/ml||Standard Deviation|Mean
1279485|NCT00277446|Primary|Exhaled Nitric Oxide|Exhaled nitric oxide at baseline (week 0) and at 4 weeks|0 and 4 weeks|Per protocol|||parts per billion (ppb)||Standard Deviation|Mean
1279486|NCT00277394|Secondary|Number of Patients With Major Bleeding Events||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses|||Patients|||Number
1279487|NCT00277394|Secondary|Number of Patients With Recurrence of Venous Thromboembolism||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses|||Patients|||Number
1279488|NCT00277394|Primary|Number of Patients With Clinically Relevant Bleeding Events||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses|||Patients|||Number
1279489|NCT00277355|Secondary|Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best). Regression based imputation was used to impute missing values.|Baseline to 18 months|The primary analyses were performed according to the intent to treat principle and included all randomized subjects. Two strategies were used to address missing data: 1. Last observation carried forward (LOCF) was used to impute missing values and 2. A secondary method of regression-based multiple imputation was also used.|||units on a scale||Standard Deviation|Mean
1279490|NCT00277355|Primary|Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]|Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in Total Functional Capacity (TFC) score of Unified Huntington's Disease Rating Scale [UHDRS] between baseline & Month 18), and to assess futility of further study of minocycline. TFC consists of five ordinally scaled items assessing a person's capacity with: 1. occupation 2. financial affairs 3. domestic responsibilities 4. activities of daily living and 5. independent living. Total score ranges from zero (worst) to 13 (best).|Baseline to 18 months|The primary analyses were performed according to the intent to treat principle and included all randomized subjects. Two strategies were used to address missing data: 1. Last observation carried forward (LOCF) was used to impute missing values and 2. A secondary method of regression-based multiple imputation was also used.|||units on a scale||Standard Deviation|Mean
1279491|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.|||units on a scale||Standard Error|Mean
1279492|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.|||units on a scale||Standard Error|Mean
1279506|NCT00277212|Secondary|Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2|Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.|||Proportion of Participants|||Number
1279493|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.|||units on a scale||Standard Error|Mean
1279494|NCT00277212|Secondary|Summary of Concomitant Medications, Phase 2||Phase 2 (52 Week Double-blind Relapse Assessment Phase)|Phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form).|||participants|||Number
1279495|NCT00277212|Secondary|Summary of Concomitant Medications, Phase 1||Phase 1 (9 to 24 Week Single-blind Stabilization Phase)|Phase 1 Safety Sample (all patients who take at least one dose of singleblind aripiprazole in Phase 1, as indicated on the study therapy form).|||participants|||Number
1279496|NCT00277212|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)|Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)|Throughout Phase 2 of the study, up to Week 52|Phase 2 safety sample|||particiapnts|||Number
1279497|NCT00277212|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment|In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient’s pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.|Up to 52 Weeks|Phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form).|||participants|||Number
1279498|NCT00277212|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment|Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block.|Throughout the study, up to Week 52|Participants with ECG evaluation from the phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.)|||particiapnts|||Number
1279499|NCT00277212|Secondary|Adjusted Mean Change From Baseline in BMI by Study Week|Adjusted for index mood episode and baseline assessment.|Baseline, Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.|||kg/m2||Standard Error|Mean
1279500|NCT00277212|Secondary|Number of Participants Showing Clinically Relevant Weight Gain by Study Week|Weight gain of at least a 7% increase from Baseline.|Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.|||Participants|||Number
1279501|NCT00277212|Secondary|Number of Participants Showing Clinically Relevant Weight Loss by Study Week|Weight Loss of at least a 7% decrease from Baseline.|Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.|||Participants|||Number
1279502|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Body Weight, Phase 2|Adjusted for index mood episode and baseline assessment|Baseline, Week 52|Participants from the phase 2 Safety Sample who had body weight evaluation at baseline and week 52 LOCF.|||kg||Standard Error|Mean
1279503|NCT00277212|Secondary|Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout Phase 2 (up to 52 weeks)|The Phase 2 Safety Sample comprises all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.|||participants|||Number
1279504|NCT00277212|Secondary|Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)|Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.|||Proportion of Participants|||Number
1279507|NCT00277212|Primary|Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)|Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.|||Proportion of Participants|||Number
1279508|NCT00277095|Primary|Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.|The percentage of participants with 50% reduction in pad weight.|18 month follow-up|As followed analysis of all patients who were treated and reached the 18 month follow-up visit|||percentage of patients||95% Confidence Interval|Number
1279509|NCT00276861|Secondary|Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment|Number of months from time of enrollment to the date of first documented progression or date of death.|6 months||||months||95% Confidence Interval|Number
1279510|NCT00276861|Primary|Response Rate as Measured by RECIST Criteria|Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.|4 - 6 months||||percentage of particpants||95% Confidence Interval|Number
1279511|NCT00276744|Primary|6-month Overall Survival|Percentage of patients survived at 6 months for patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model|6 months||||percentage of participants|||Number
1279512|NCT00276614|Primary|Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses||2 months|2 subjects were excluded from analysis as they completed less than 2 cycles of study therapy.|||participants|||Number
1279513|NCT00276549|Primary|Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).|Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease.|at 4 weeks after treatment completion|25 patients had RECIST defined measurable disease at study entry. Confirmed response required 2 consecutive measurements at least 1 week later.Three patients did not have follow up measurements therefore were not evaluable.|||participants|||Number
1279514|NCT00276549|Primary|Objective PSA Response Rate (Number of Patients With a PSA Response)|Decline from a baseline value by ≥ 50% or normalization of PSA (< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized.|every 4 weeks|All patients that received treatment.|||participants|||Number
1279515|NCT00276484|Secondary|Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6||6 Weeks|Full Analysis Set|||Participants|||Number
1279516|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)|Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1279517|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio|Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1279518|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio|Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1279519|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio|Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent change||95% Confidence Interval|Least Squares Mean
1279520|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio|Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks||||Percent Change||95% Confidence Interval|Least Squares Mean
1279521|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)|Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1279522|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)|Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1279523|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Triglycerides (TG)|Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1279524|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Total-Cholesterol|Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1279525|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)|Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1279526|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)|Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
1286840|NCT00167180|Secondary|Number of Patients With Acute Graft-Versus-Host Disease|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100||||Participants|||Count of Participants
1279527|NCT00276484|Primary|Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C|Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1279528|NCT00276458|Secondary|Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6||6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Participants|||Number
1279529|NCT00276458|Post-Hoc|Percent Change in C-Reactive Protein (CRP) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279530|NCT00276458|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||percent||95% Confidence Interval|Least Squares Mean
1279531|NCT00276458|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279532|NCT00276458|Secondary|Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279533|NCT00276458|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279534|NCT00276458|Secondary|Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279535|NCT00276458|Post-Hoc|Percent Change in Apolipoprotein A-I at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279536|NCT00276458|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279537|NCT00276458|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279538|NCT00276458|Secondary|Percent Change From Baseline in Total-Cholesterol at Week 6|([6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||percent||95% Confidence Interval|Least Squares Mean
1279539|NCT00276458|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279540|NCT00276458|Secondary|Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279541|NCT00276458|Primary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
1279542|NCT00276419|Secondary|Mean Days of Pain During the 10 Week Treatment Periods|Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated.|Approximately 12 weeks and at 24 weeks after randomization|||||||
1279543|NCT00276419|Primary|Severity of Breast Pain|Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.|4 weeks, 10 weeks|||||||
1279544|NCT00276419|Primary|Frequency of Breast Pain|Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.|4 weeks, 10 weeks|||||||
1279545|NCT00276406|Secondary|QTc Interval Before and After Treatment|The corrected QT interval (QTc) is a measurement of time (seconds) between the Q and T waves of an heart beat as recorded during an Electrocardiogram (ECG).|Baseline period (9 days), Treatment period (7 days)||||Milliseconds||Standard Error|Mean
1279546|NCT00276406|Secondary|Heart Rate Before and After Treatment|Heart rate is the number of beats per minute, as recording on an Electrocardiogram (ECG).|Baseline period (9 days), Treatment period (7 days)||||beats per minute||Standard Error|Mean
1279547|NCT00276406|Secondary|Stool Frequency Per Week|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Complete spontaneous bowel movements per week are reported. Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)||||Number complete bowel movements per week||Standard Error|Mean
1279548|NCT00276406|Secondary|Sense of Completely Emptying Bowels|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record whether or not they felt they had completely emptied their bowels(1= Yes; 0= No). Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)||||percentage of bowel movements||Standard Error|Mean
1279549|NCT00276406|Secondary|Stool Ease of Passage|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool ease of passage of stool, according to the Bristol Stool Form Scale (ranging from 1 (manual disimpaction) to 7 (incontinence)). Only the 7 days at highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)||||units on a scale||Standard Error|Mean
1279550|NCT00276406|Secondary|Stool Form/Consistency|"During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool consistency according to the Bristol Stool Form Scale (ranging from 1 (hard lumps) to 7 (watery)). The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|Daily during baseline period (9 days), Treatment period (7 days)||||units on a scale||Standard Error|Mean
1279551|NCT00276406|Secondary|Stool Frequency Per Day|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)||||Number of bowel movements||Standard Error|Mean
1279552|NCT00276406|Secondary|Colonic Geometric Center at 48 Hours (GC48) as Measured by Scintigraphy|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC48 is the measurement taken at 48 hours after the radio-labeled meal.|Baseline period (days 7-9 ), Treatment period (days 14-17)||||units on a scale||Standard Error|Mean
1279553|NCT00276406|Secondary|Colonic Filling at 6 Hours|The proportion of a radio-labeled meal in the colon at 6 hours (identifiable by radio-labelled tracer to capsule eaten with meal), measured by scintigraphy. This is an indirect measurement of small-bowel transit time.|Baseline period (9 days), Treatment period (7 days)||||percentage of meal||Standard Error|Mean
1279554|NCT00276406|Secondary|Gastric Emptying Half-time (GE t1/2)|The measure of time for 50 percent of a radio-labeled meal to empty from the stomach.|Baseline period (9 days), Treatment period (7 days)||||minutes||Standard Error|Mean
1279555|NCT00276406|Primary|Ascending Colon Emptying Half-time (AC t1/2) Measured in Hours|Calculated by linear interpolation of values on the AC emptying curve.|Baseline period (days 7-9 ), Treatment period (days 14-17)||||hours||Standard Error|Mean
1279556|NCT00276406|Primary|Colonic Geometric Center at 24 Hours (GC24) Measured by Scintigraphy|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images of the abdomen are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC24 is the measurement taken at 24 hours after the radio-labeled meal.|Baseline period (days 7-9 ), Treatment period (days 14-17)||||units on a scale||Standard Error|Mean
1279557|NCT00276380|Secondary|Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168.|"The NIHSS was to be used to objectively quantify the impairment caused by the stroke.The NIHSS is composed of 11 items, each of which score a specific ability between 0 (normal function) and 4 (high level of impairment).The minimum total score is 0 and maximum is 42. Only 8 of the NIHSS subscores were calculated for this study.~Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. Mean NIHSS subscores for questions 1a (level of consciousness),1b (asking patient the month and their age), and 1c (asking to open and close eyes) were analysed using descriptive quantitative statistics at each visit and the mean change from baseline at each time point is reported. The range for the subscore for items 1a is 0 - 3, for 1b is 0 - 2 and for 1c is 0 - 2 (best to worst), with a negative mean change from baseline indicating an improvement."|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||units on a scale||Standard Deviation|Mean
1279558|NCT00276380|Secondary|Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.|The MMS test was used to evaluate the cognitive function of the subject. It includes tests of orientation, attention, memory, language and visual spatial skills, which are rated with a given number of points assigned to each level or ranking. The lower the score, the more important the mental deficit. The total score range is from 0 to 30 (worst to best), with a positive mean change indicating an improvement (i.e. less mental deficit). Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||units on a scale||Standard Deviation|Mean
1279559|NCT00276380|Secondary|Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.|"The performance in activities of daily living was assessed by using the Barthel scale. The Barthel scale is an ordinal scale which measures 10 performance items describing activities of daily living. Each item is rated with a given number of points from 0 indicating total dependence up to a maximum of 10 or 15 (depending on performance item) indicating complete independence. The total score range is from 0 to 100 (worst to best), with a positive mean change indicating an improvement in independence.~Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported."|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||units on a scale||Standard Deviation|Mean
1279560|NCT00276380|Secondary|Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.|The SCAG scale was to be used to evaluate the psychopathological state of the subject. It is composed of 18 symptom areas and an overall global assessment, all rated on a 7-point format from 1=not present to 7=severe. The total score range is from 19 to 133 (best to worst), with a negative mean change from baseline indicating an improvement in symptoms. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||units on a scale||Standard Deviation|Mean
1279561|NCT00276380|Secondary|Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.|The degree of disability and dependence in daily activities was assessed using the modified Rankin scale.The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability,3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The distribution of subjects according to disability severity scores was assessed and the percentage of subjects at each point on the modified Rankin scale are reported for each time point.|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||percentage of participants|||Number
1279562|NCT00276380|Secondary|Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.|The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at each follow-up visit (not including end of study) are reported.|Up to Day 84|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||percentage of participants|||Number
1279563|NCT00276380|Primary|Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.|The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at the end of the study (Day 168) are reported.|Day 168|This analysis was performed on the Intention-To-Treat (ITT) population which includes all subjects having at least one treatment dose.|||percentage of participants|||Number
1279564|NCT00276250|Secondary|Number of Subjects With Normal Renal Function, as Measured by Serum Creatinine Levels|Renal function was assessed by measuring levels of serum creatinine. Normal values range from 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women.|24 months after transplant|One subject in the Efalizumab followed by abatacept regimen arm withdrew from the the study at 18 months post-transplantation and therefore did not have the 24-month assessments.|||participants|||Number
1279589|NCT00276094|Primary|Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity|This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12||||Units on a scale||Standard Deviation|Mean
1279565|NCT00276250|Secondary|The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.|The number of study participants who have detectable C-peptide levels after stimulation from a Mixed Meal Test. An increase of C-peptide indicates that insulin is being released normally in response to food consumption.|1, 3, 6, 9,12,18 and 24 months post-transplantation|C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm for 18 and 24 months post-transplant|||participants|||Number
1279566|NCT00276250|Secondary|Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels|The number of subjects exhibiting C-peptide levels ≥ 0.5 ng/mL was recorded.|1, 3, 6, 9,12,18 and 24 months post-transplantation|C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm at the 18 and 24 months post-transplant timepoints.|||participants|||Number
1279567|NCT00276250|Secondary|Number of Subjects With HbA1C < 6.5%|HbA1C was assessed in the subjects 36 months after transplantation and the number of subjects with values < 6.5% was recorded which indicated better control of blood glucose levels.|36 months post-transplantation|Two participants in the Efalizumab followed by abatacept regimen arm were terminated prior to this time point due to islet graft failure; another one withdrew as they did not want to change to abatacept. The single participant in the Abatacept arm withdrew after graft failure which occurred at 6months post-transplantation.|||participants|||Number
1279568|NCT00276250|Secondary|Number of Subjects With HbA1C < 6.5%|HbA1C was assessed in the subjects 24 months after transplantation and the number of subjects with levels < 6.5% was recorded which indicated better control of blood glucose levels.|24 months post-transplant|One participant in the Efalizumab followed by abatacept regimen arm had partial graft function and withdrew from the study at 18 months post-transplantation (prior to this time point of assessment).|||participants|||Number
1279569|NCT00276250|Secondary|Number of Subjects With HbA1C Levels < 6.5%|HbA1C was assessed in the subjects 12 months after transplantation and the number of subjects with levels < 6.5% was recorded which indicated better control of blood glucose levels.|12 months post-transplantation||||participants|||Number
1279570|NCT00276250|Secondary|Number of Subjects With HbA1C Less Than 6.5%|HbA1C was assessed in the subjects 6 months after transplantation and the number of subjects with values less than 6.5% was recorded which indicated better control of blood glucose levels.|6 months post-transplantation|The HbA1C for the subject in the abatacept arm was above the threshold (6.5%) for this measure.|||participants|||Number
1279571|NCT00276250|Secondary|Number of Insulin-independent Subjects Following Islet Transplantation|Participants who did not need to take insulin at 1, 3, 6, 9, 12, 18, and 24 months following islet transplantation|1, 3, 6, 9,12,18 and 24 months post-transplantation||||participants|||Number
1279572|NCT00276250|Primary|The Number of Insulin-independent Subjects at Day 75 (± 5 Days) Following the First Islet Cell Transplantation||75 days post-transplantation||||participants|||Number
1279573|NCT00276159|Secondary|Peak Concentrations of 852A|Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.|Up to Week 12|Not able to analysis due to sale of agent - unable to perform.||||||
1279574|NCT00276159|Secondary|Measure of Immune Activation With Correlative Laboratory Studies||Up to Week 12|Analysis not done to sale of agent - unable to perform.||||||
1279575|NCT00276159|Secondary|Number of Patients Who Received Steroids|Number of patients who received steroids allowing successful continuation of therapy.|Up to Week 12|Includes patients receiving at least 12 doses of 852A study drug.|||Participants|||Number
1279576|NCT00276159|Primary|Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors|Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.|Up to Week 12|Includes patients receiving at least 12 doses of 852A study drug.|||Participants|||Number
1279577|NCT00276094|Secondary|Change From Baseline in Urinary Symptoms||Baseline (Randomization) to Week 12||||Participants|||Number
1279578|NCT00276094|Secondary|Change From Baseline in Testosterone (Total) Levels||Baseline (Screening) to Week 12||||ng/dL||Standard Deviation|Mean
1279579|NCT00276094|Secondary|Change From Baseline in Testosterone (Free) Levels||Baseline (Screening) to Week 12||||ng/dL||Standard Deviation|Mean
1279580|NCT00276094|Secondary|Change From Baseline in Sex Hormone Binding Globulin Levels||Baseline (Screening) to Week 12||||nmol/L||Standard Deviation|Mean
1279581|NCT00276094|Secondary|Change From Baseline in Luteinizing Hormone Levels||Baseline (Screening) to Week 12||||IU/L||Standard Deviation|Mean
1279582|NCT00276094|Secondary|Change From Baseline in Follicle Stimulating Hormone Levels||Baseline (Screening) to Week 12||||IU/L||Standard Deviation|Mean
1279583|NCT00276094|Primary|Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear||Baseline (Screening) to Week 12||||percentage of superficial cells||Standard Deviation|Mean
1279584|NCT00276094|Secondary|Change From Baseline in Estradiol Levels||Baseline (Screening) to Week 12|"Analysis populations for each hormone:~Ospemifene(30 mg): E2-231, FSH-232, LH-231, SHBG-232, Testosterone(free)-183, Testosterone(total)-183 Ospemifene(60 mg): E2-221, FSH-222, LH-222, SHBG-221, Testosterone(free)-175, Testosterone(total)-176 Placebo: E2-216, FSH-216, LH-216, SHBG-216, Testosterone(free)-178, Testosterone(total)-178"|||pg/mL||Standard Deviation|Mean
1279585|NCT00276094|Secondary|Change From Baseline in Severity of VVA Symptoms|This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12||||Units on a scale||Standard Deviation|Mean
1279586|NCT00276094|Secondary|Change From Baseline in Visual Evaluation of the Vagina|Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Screening) to Week 12||||Units on a scale||Standard Deviation|Mean
1279587|NCT00276094|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear||Baseline (Screening) to Week 12||||percentage of parabasal cells||Standard Deviation|Mean
1279588|NCT00276094|Primary|Mean Change From Baseline in Vaginal pH||Baseline (Screening) to Week 12||||pH||Standard Deviation|Mean
1279590|NCT00276094|Primary|Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness|This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12||||Units on a scale||Standard Deviation|Mean
1279591|NCT00276016|Secondary|The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.|"To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo~The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results."|Baseline to endpoint (6 hour period)||||Units on a scale||Standard Deviation|Mean
1279592|NCT00276016|Primary|The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo|"To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing.~The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results."|Baseline to endpoint (6 hour period)||||Units on a scale||Standard Deviation|Mean
1279593|NCT00275834|Secondary|Change in Blood Pressure||Baseline, 1 year||||mm Hg||95% Confidence Interval|Least Squares Mean
1279594|NCT00275834|Secondary|Quality of Life as Measured by HADS_D|Hospital Anxiety and Depression Scale - Depression (HADS-D) The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|1 year||||units on a scale||95% Confidence Interval|Least Squares Mean
1279595|NCT00275834|Secondary|Change in Lipids||baseline, 1 year||||mg/dL||95% Confidence Interval|Least Squares Mean
1279596|NCT00275834|Secondary|Inflammatory Markers (CRP)|C reactive Protein (CRP)|1 year|Participants who had CRP testing completed|||mg/L||Standard Error|Mean
1279597|NCT00275834|Secondary|Waist Circumference|Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect.|1 year|intent-to-treat|||cm||95% Confidence Interval|Mean
1279598|NCT00275834|Secondary|Proportions of Patients With 10% Weight Loss|This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.|1 year||||participants|||Number
1279599|NCT00275834|Secondary|Proportions of Patients With 5% Weight Loss|These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.|1 year||||participants|||Number
1279600|NCT00275834|Primary|Change in Body Weight|The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.|1 year|intent-to-treat|||kg||95% Confidence Interval|Mean
1279601|NCT00275821|Secondary|Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.|Baseline to Month 12|Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.|||Micrometers||Standard Deviation|Mean
1279602|NCT00275821|Secondary|Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.|Baseline to Month 12|Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.|||micrometers||Standard Deviation|Mean
1279603|NCT00275821|Secondary|Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12|Fluorescein angiography was conducted in conjunction with color fundus photography at screening and at Months 6 and 12. Investigators used digital fluorescein angiograms to determine presence or absence of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).|Baseline to Month 12|The intent to treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.|||mm^2||Standard Deviation|Mean
1279604|NCT00275821|Primary|Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12|Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.|Baseline to Month 12|Per-Protocol (PP) population includes a subset of patients from the Intent to Treat (ITT) population who completed Month 12/Visit 15, had an assessment of Best Corrected Visual Acuity in the study eye at Month 12/Visit 15 and did not have any major study protocol deviations.|||letters||Standard Deviation|Mean
1279605|NCT00275561|Secondary|Number of Participants With Complete Histologic Response|A complete histologic response was defined as >90% decrease in mean eosinophil count/high powered field|2 weeks|Analysis was run per protocol.|||participants|||Number
1279606|NCT00275561|Secondary|Number of Participants With Partial or Complete Response to Dysphagia|"Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of no to the question In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)? A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level."|2 weeks|Analysis was run per protocol.|||participants|||Number
1279607|NCT00275561|Primary|Number of Participants With Complete Response to Dysphagia|"Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of no to the question In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"|2 weeks|Analysis was run per protocol.|||participants|||Number
1279608|NCT00275509|Primary|6-month Cumulative Rejection Incidence (Either CMR, AMR or Both)|Biopsy shows evidence of either AMR or CMR or evidence both.|Up to 6 months|One patient in the Thymoglobulin arm died on post-operative day #8, prior to undergoing a biopsy. There were other deaths in the study however there were incidences of CMR, AMR or both prior to death.|||Participants|||Count of Participants
1279609|NCT00275509|Primary|6-month Acute Antibody-mediated Rejection Rate (AMR)|A diagnosis of AMR was based on the 2013 international Banff Classification Criteria and is defined as the presence of circulating donor-specific antibody (DSA) and either: 1) peritubular capillary staining of C4d and at least one of the following: peritubular capillaritis (ptc) score>0, glomerulitis (g) score>0, acute thrombotic microangiopathy (TMA) in the absence of any other cause, or other features consistent with AMR (endothelial injury, fibrin thrombi, microinfarctions, interstitial hemorrhage), or 2) absence of capillary staining of C4d and the presence of ptc>0 and g>0 or ptc>0 or g>0 and acute TMA, in the absence of any other cause of TMA.|Up to 6 months|One patient in the Thymoglobulin arm died on post-operative day #8, prior to undergoing a biopsy. There were other deaths in the study however there were incidences of CMR, AMR or both prior to death.|||Participants|||Count of Participants
1279610|NCT00275509|Primary|6-month Acute Cellular-mediated Rejection Rate (CMR)|Per 2007 international Banff Classification Criteria, CMR 1A was diagnosed on biopsies displaying significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2). CMR IB was diagnosed in cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of severe tubulitis (t3). CMR IIA were cases with mild-to-moderate intimal arteritis (v1), while CMR IIB were those with severe intimal arteritis comprising >25% of the luminal area (v2). CMR III were those cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3).|Up to 6 months|One patient in the Thymoglobulin arm died on post-operative day #8, prior to undergoing a biopsy. There were other deaths in the study however there were incidences of CMR, AMR or both prior to death.|||Participants|||Count of Participants
1279611|NCT00275392|Secondary|Dynamic Visual Acuity|Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.|6 weeks||||LogMAR||Standard Deviation|Mean
1279612|NCT00275392|Primary|Dynamic Gait Index|Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of < 20 indicates risk for falling.|6 weeks|Per-protocol analyses (i.e., only subjects who completed the intervention were included).|||units on a scale||Standard Deviation|Mean
1279613|NCT00275340|Secondary|Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)||9 weeks||2009-09-30|09/2009||||
1279614|NCT00275340|Secondary|Function (Human Activity Profile)||9 weeks||2009-09-30|09/2009||||
1279615|NCT00275340|Secondary|Interference With Activities (Brief Pain Inventory-Interference Subscale)||9 weeks||2009-09-30|09/2009||||
1279616|NCT00275340|Secondary|Pain (McGill Pain Questionnaire-Short Form)||9 weeks||2009-09-30|09/2009||||
1279617|NCT00275340|Primary|Health-related Quality of Life (SF-36v2-acute Form)|The SF-36v2 yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.|9 weeks||||units on a scale||Standard Deviation|Mean
1279618|NCT00275301|Primary|Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan|The primary aim of this imaging study was to examine the effect of olanzapine on brain metabolism over the eight weeks of administration. To compare the baseline PET scan to the endpoint scan,|Baseline to 8 weeks||||Standard uptake value||Standard Deviation|Mean
1279619|NCT00275275|Secondary|Number of Dose Adjustments|Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.|Week 4||||number of adjustments||Standard Deviation|Mean
1279620|NCT00275275|Primary|Adverse Effects Experienced|Number of adverse effect experienced by participants in the different conversion ratio groups.|Week 4||||number of events|||Number
1279621|NCT00275262|Primary|Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Interferon gamma was determined by enzyme-linked immunosorbent spot-forming cell (ELISpot). Baseline is defined as the interferon gamma concentration obtained before the KLH vaccination. Change from baseline was calculated as the interferon gamma value postvaccination minus the interferon gamma value at baseline.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||spots/1 million cells||Standard Deviation|Mean
1279967|NCT00270855|Secondary|High Density Lipoprotein Cholesterol (HDL) Between Groups|Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
1279622|NCT00275262|Primary|Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgG1 antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgG1 concentration before the KLH vaccination. Change from baseline was calculated as the IgG1 value postvaccination minus the IgG1 value at baseline.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||mcg/mL||Standard Deviation|Mean
1279623|NCT00275262|Secondary|Mean Change From Baseline in TREC Per 100,000 CD8+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant|"CD8+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD8+ cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010~The change from baseline is defined as posttransplant TREC/100,000 CD8+ cells minus pretransplant TREC /100,000 CD8+ cells."|Pretransplant and posttransplant (Month 12)|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD8+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||TREC /100,000 CD8+ cells||Standard Deviation|Mean
1279624|NCT00275262|Secondary|Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant|"CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010~The change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells."|Pretransplant and posttransplant (Month 12)|Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||TREC /100,000 CD4+ cells||Standard Deviation|Mean
1279625|NCT00275262|Primary|Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||mcg/mL||Standard Deviation|Mean
1279626|NCT00275028|Secondary|Progression-free Survival||Up to 2 years||||weeks||Standard Error|Mean
1279627|NCT00275028|Primary|Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RESIST)~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|Up to 12 months||||participants|||Number
1279628|NCT00275002|Secondary|Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide|Clinical and laboratory studies to assess adverse events are obtained at least every four weeks (prior to each course) with some laboratory studies obtained every 2 weeks. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Attribution of each adverse event to the treatment regimen is determined by the participant's attending physician at the enrolling institution and verified by the study chair.|From day 1 of therapy up to 49 months|Participants who received at least one day of the treatment regimen were included in the analysis of this objective.|||Participants|||Number
1279629|NCT00275002|Primary|Percentage of Participants With an Objective Response (Complete Response or Partial Response)|The primary endpoint is to assess the percentage of participants with a sustained objective response (complete response (CR) or partial response (PR)). Response is assessed by magnetic resonance imaging (MRI) per the following criteria: CR - disappearance of tumor and PR - ≥50% reduction in tumor based on the maximal cross-sectional measurements. The response must be sustained for at least 8 weeks, and the date of the confirmed sustained response is the date at which the response was first noted by MRI.|Week 8, 16, 24, 32, and 40 after starting therapy|Participants included in assessing objective response were those who completed two courses of therapy or those who died or experienced progressive disease prior to completing the second course.|||Percent of Participants||95% Confidence Interval|Number
1279630|NCT00274937|Secondary|Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.|Weight of unstimulated saliva production in grams.|At study enrollment|Twenty-nine patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of unstimulated saliva production. This outcome measure was only collected for patients in Stratum 2.|||Grams of saliva||Standard Deviation|Mean
1279631|NCT00274937|Secondary|Protective Effects of Amifostine Assessed Primarily by Sialometry|Weight of stimulated saliva production in grams.|At study enrollment|Twenty-six patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of stimulated saliva production. This outcome measure was only collected for patients in Stratum 2.|||Grams of saliva||Standard Deviation|Mean
1279632|NCT00274937|Secondary|Predictive Value of the Detection of EBV DNA in the Peripheral Blood|The prognostic value of the presence of EBV DNA will be assessed using the log-rank test, adjusted by initial stage of disease, if appropriate. The proposed analysis will take place at the analytic endpoint of the clinical trial.|Up to 6 years|Funding was not obtained and results will never be reported.||||||
1279633|NCT00274937|Secondary|Prognostic Significance of EBV Viral Load|Viral load in blood.|At study enrollment|Data was and never will be collected.||||||
1279634|NCT00274937|Secondary|Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment|Presence of EBV DNA in serum.|At study enrollment|Data was and never will be collected.||||||
1279635|NCT00274937|Primary|Two Year Event-free Survival (EFS)|The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.|Up to Two Year After Enrollment|No patients were enrolled to Stratum 1.|||Estimated probability||95% Confidence Interval|Number
1279636|NCT00274924|Secondary|5-year Overall Survival|5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival.|Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.||||probability||90% Confidence Interval|Number
1279637|NCT00274924|Primary|2-year Progression-Free Survival (PFS)|2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS.|Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.||||probability||90% Confidence Interval|Number
1279638|NCT00274846|Secondary|Number of Patients With Complete Remission and Natural Killer Cell Expansion|Includes patients who had both a complete remission of disease and an expansion of natural killer cells.|Day 14|Unable to evaluate due to low complete remission rate.||||||
1279639|NCT00274846|Secondary|Overall Survival Time of Patients With Complete Remission|Median number of months patients were alive after NK cell infusion.|From Day 1 of Treatment until death or patient received bone marrow transplant.||||Months||Full Range|Median
1279640|NCT00274846|Secondary|Median Time to Disease Relapse (Months)|Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood.|From 1st Day of treatment until death or receipt of bone marrow transplant.|Only 2 of 20 patients that received adequate Natural Killer Cells achieved complete remission, and were therefore evaluable for the time to relapse endpoint.|||Months||Full Range|Median
1279641|NCT00274846|Secondary|Number of Patients With Complete Remission|Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery).|Day 28-35||||Participant|||Number
1279642|NCT00274846|Primary|Number of Patients With Natural Killer (NK) Cell Expansion|Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14).|Study Day 14||||Participants|||Number
1279643|NCT00274781|Secondary|Tolerability|Tolerability of Therapy was assessed through use of the National Cancer Institute Common Toxicity Criteria (version 3.0). Treatment tolerability was determined based upon whether or not the physician determined therapy was in the patient's best interest, whether the patient wanted to continue therapy or not, whether patients discontinued treatment due to progressive disease, or whether patients discontinued treatment due to toxicity.|12 Weeks||||participants|||Number
1279644|NCT00274781|Secondary|Overall Survival|Patient's Overall Survival from date of enrollment to a minimum of three years for survival.|From date of enrollment to a minimum of three years for survival||||months||Full Range|Median
1279645|NCT00274781|Primary|Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)|The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is <10%. A total of >/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizations allow for the responses to be determined as either complete responses or partial responses.|at 12 weeks post treatment|Responses According to IWG MDS Criteria (n=30) Responses According to IWG AML Criteria (n=12)|||percentage of patients|||Number
1279646|NCT00274768|Secondary|Adherence and Compliance to Oral Medication Using Electronic Monitoring||Every 3 weeks|||||||
1279647|NCT00274768|Secondary|Pharmacokinetic and Pharmacodynamic Effects||Time to progression|||||||
1279648|NCT00274768|Secondary|Clinical Benefit, Time to Treatment Failure, Safety and Toxicity||Time to progression|||||||
1279649|NCT00274768|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Participants were followed to progression, evaluated every 12 weeks|Any participant who completed at least one (1) cycle of capecitabine administration was evaluable for response.|||participants|||Number
1279968|NCT00270855|Secondary|Triglycerides Between Groups|Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
1279650|NCT00274742|Secondary|Objective Tumor Response According to the Cheson Criteria (With Minimal Response)|"Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Minimal response was treated as a separate response category in this analysis. Best clinical response was defined as the best response achieved during the course of the study, whereby the following order was applied: Complete Response, Complete Response Unconfirmed, Partial Response, Minimal Response, Stable Disease, and Progressive Disease.~If no post-baseline tumor assessment was available, the overall clinical response was set to not available."|Assessed after 4 and 8 weeks of treatment|All participants who received at least one infusion of blinatumomab|||participants|||Number
1279651|NCT00274742|Secondary|Objective Tumor Response According to the Cheson Criteria (Without Minimal Response)|"Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration).~Best clinical response is defined as the best response achieved during the course of the study, with response defined as: Complete Response, Complete Response Unconfirmed, Partial Response, Stable Disease, and Progressive Disease. In this analysis minimal response is set to stable disease as intended in the response categories according to the Cheson criteria. An independent external review by a radiologist (computed tomography scans) and a pathologist (biopsies) was performed to confirm response status.~If no post-baseline tumor assessment was available, the overall clinical response was set to not available."|Assessed after 4 and 8 weeks of treatment|All participants who received at least one infusion of blinatumomab|||participants|||Number
1279652|NCT00274742|Secondary|Serum Concentration of Blinatumomab|The steady state serum concentration (Css), summarized as the observed concentrations collected at least 10 hours after the start of continuous intravenous infusion or within the sampling window at the end of infusion. Concentrations below the lower limit of quantitation (100 pg/mL) were excluded from analysis.|Up to 24 hours after the end of infusion.|Participants who received blinatumomab and had available pharmacokinetic data|||pg/mL||Standard Deviation|Mean
1279653|NCT00274742|Primary|Number of Participants With Adverse Events|Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events|From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days.|All participants who received at least one infusion of blinatumomab|||participants|||Number
1279654|NCT00274716|Primary|Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.|||Participants|||Number
1279655|NCT00274716|Primary|Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.|||Participants|||Number
1279656|NCT00274716|Primary|Number of Participants Who Reported a Laboratory Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.|||Participants|||Number
1279657|NCT00274716|Primary|Number of Participants Who Reported a Clinical Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.|||Participants|||Number
1279658|NCT00274716|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)|TG measured at baseline and after 12 weeks of study drug administration|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||Percent change||Standard Deviation|Mean
1279659|NCT00274716|Secondary|Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI|HDL-C measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||Percent change||Standard Deviation|Mean
1279660|NCT00274716|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)|LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||percentage change||Standard Deviation|Mean
1279661|NCT00274716|Secondary|Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI|Waist circumference measured in cm at baseline and after 12 weeks of study drug administration|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||cm||Standard Deviation|Mean
1279662|NCT00274716|Secondary|Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI|Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||kg||Standard Deviation|Mean
1279663|NCT00274716|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)|Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||mm Hg||Standard Deviation|Mean
1279664|NCT00274716|Primary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)|Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||mm Hg||Standard Deviation|Mean
1279665|NCT00274651|Post-Hoc|Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)|Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.|throughout the study, or for a maximum of 2 years|At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals|||participants|||Number
1279666|NCT00274651|Secondary|Duration of Response|Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.|throughout the study, or for a maximum of 2 years|Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days|||Days||Full Range|Median
1279667|NCT00274651|Secondary|Time to Response|Time to response was defined as the interval between the first date of treatment and the first notation of response.|throughout the study, or for a maximum of 2 years|Time to response (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. For 4 patients with CTCL and 6 patients with PTCL, response was recorded. The median time to response and the full range (days) are presented.|||Days||Full Range|Median
1279668|NCT00274651|Secondary|Time to Progression|Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.|throughout the study, or for a maximum of 2 years|Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.|||Days||Full Range|Median
1279669|NCT00274651|Primary|Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))|Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.|throughout the study, or for a maximum of 2 years|Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama & Chen (2008) are presented|||percentage of patients with OR|||Number
1279670|NCT00274651|Primary|Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)|Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.|throughout the study, or for a maximum of 2 years|At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals||||||
1279969|NCT00270855|Secondary|Lower Limb Bone Mineral Content Between Groups|Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||grams||Standard Deviation|Mean
1279671|NCT00274625|Primary|Incisional Hernia|An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality.|2 years|14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.|||participants|||Number
1279672|NCT00274469|Secondary|Duration of Clinical Benefit|Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|143 of the 205 patients on the study had clinical benefit. Of those 143 patients, 23 subsequently progressed.|||Number of CB patients progressed|||Number
1279673|NCT00274469|Secondary|Duration of Response|Time from randomization until earlier of progression or death measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|65 of the 205 patients on the study had confirmed RECIST response. Of those 65 responding patients, 14 subsequently progressed.|||Number of responders who progres|||Number
1279674|NCT00274469|Secondary|Time to Progression|Time from randomization until earlier of disease progression or death|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|73 of the 205 patients on the study had progressed at the time of data cut-off.|||Number of patients who progressed|||Number
1279675|NCT00274469|Secondary|Objective Response Rate|An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CRif she had overall response of CR or PR on one visit and met the confirmation criteria perRECIST. ORR is defined as percentage of patients with objective response.|Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.||||Percentaage||Standard Deviation|Mean
1279676|NCT00274469|Primary|Clinical Benefit Rate|A Clinical Benefit (CB) responder is defined as a patient having a best overall response ofCR, PR or SD provided SD (or better) was present ≥ 154 days from randomization (ie SD ≥ 24weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria In Solid Tumours) scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.||||Percentage||Standard Deviation|Mean
1279677|NCT00274456|Other Pre-specified|Nadir of Myelosuppression (Over All Cycles) as Measured by Hemoglobin (Hb) Counts|Maximal degree of myelosuppression is represented by the nadir in hemoglobin (Hb) measurements over all treatment cycles.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.|||g/L||Standard Deviation|Mean
1279678|NCT00274456|Secondary|Participants With Treatment-Emergent, Treatment-Related Adverse Events|Summary of participants who had treatment-emergent that were treatment-related in the opinion of the investigator, and summarized in a variety of categories. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||participants|||Number
1279679|NCT00274456|Other Pre-specified|Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts|Maximal degree of myelosuppression is represented by the nadir in absolute neutrophil (ANC), white blood cell (WBC), and platelet measurements over all treatment cycles.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.|||10^9/L||Standard Deviation|Mean
1279680|NCT00274456|Secondary|Kaplan-Meier Estimate for Overall Survival (OS)|Participant survival was defined as the date of randomization to the date of death. Participants that were alive at the time of analysis were censored at the last known time that the participant was alive. The final analysis of mature overall survival was conducted after 2 years of follow-up (data cutoff date 31 Jan 2010).|Day 1 to 221 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||months||95% Confidence Interval|Median
1279681|NCT00274456|Secondary|Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression|Duration of response was measured as the progression-free survival on patients with confirmed response. The investigator assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.|Day 1 - 95 weeks|Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|||months||95% Confidence Interval|Median
1279682|NCT00274456|Secondary|Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression|Duration of response was measured as the progression-free survival on patients with confirmed response. The independent radiology assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.|Day 1 - 95 weeks|Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|||months||95% Confidence Interval|Median
1279683|NCT00274456|Secondary|Kaplan-Meier Estimates for Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the start of disease progression (PD) or patient death (any cause), whichever occurred first. Patients without disease progression were censored at the last time the patient was known to be progression-free. Patients who initiated new anticancer therapy prior to documented progression or death were censored at the start of new therapy. Disease progression was assessed separately by investigators and by an independent radiologist. Both assessments are offered. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000). PD for target lesions is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||months||95% Confidence Interval|Median
1279684|NCT00274456|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response|Known as the disease control rate, this outcome measures the percentage of participants with stable disease for 16 weeks or more, or had a confirmed complete or partial response (see outcome #1 for confirmed response definitions). Assessments made by independent radiology and by investigators are reported separately|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
1279685|NCT00274456|Primary|Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator|Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
1279686|NCT00274287|Secondary|These Include Response Rate (RR), Overall Survival (OS), Toxicity and Safety of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), and Time to Requiring Additional Systemic Chemotherapy (TTRC)||time events happen|||||||
1279687|NCT00274287|Primary|Time to Disease Progression (TTP)|The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically.|time to disease progression (up to 6 months)|Per protocol.|||months||Full Range|Median
1279688|NCT00274261|Secondary|Incidence of Adverse Events.|Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.|duration of the study - through 6 month or 12 months of use||||Participants|||Count of Participants
1279689|NCT00274261|Primary|The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.|Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.|6 months|Modified Intent-To-Treat (MITT): ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as “Typical-Use”) and for whom there is at least one report of pregnancy status.|||6 month probability of pregnancy||95% Confidence Interval|Number
1279690|NCT00273910|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|48 months||||Participants|||Number
1279691|NCT00273910|Primary|Immunologic Response Rate|Comparison of six different preparations of the gp100:209-217 (210M) melanoma antigen peptide. The arm with the greater number of immunologic responses will be the one most likely to be selected for future study on the basis of immunization alone. Evidence of immunization consist of at least 10 Elispots/100,000 cells above background. An injection site reaction is not an immune response.|48 months|The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.|||Participants|||Number
1279692|NCT00273858|Secondary|Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month|PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.|Baseline, Month 24|Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.|||mm|||Number
1279693|NCT00273858|Secondary|Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month|PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.|Baseline, Month 24|Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.|||Millimetre (mm)|||Number
1279694|NCT00273858|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation.|Baseline, Month 24|Data was not analyzed as the usage of the questionnaire was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.|||Units on a Scale|||Number
1279695|NCT00273858|Primary|Number of Participants by Reasons for Discontinuation of Treatment||Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.|||Participants|||Number
1279696|NCT00273858|Primary|Number of Participants Who Discontinued Treatment||Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.|||Participants|||Number
1279697|NCT00273858|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.|||Participants|||Number
1279698|NCT00273793|Secondary|Average Number Cigarettes Reported Smoked Each Day in the Past Week Measured at Follow-up Six Months After Entry Into the Study|average number cigarettes reported smoked each day in the past week at follow up six months after study entry|past week at follow-up six months after study entry||||cigarettes per day||Standard Deviation|Mean
1279699|NCT00273793|Primary|Breath Carbon Monoxide Levels Indicating Smoking Abstinence During the Study, i.e., the Number of Breath Samples With Carbon Monoxide (CO) Levels Less Than 3 Parts Per Million (Ppm)||daily for breath CO|all subjects randomized to condition|||number breath samples < 3 ppm CO||Inter-Quartile Range|Median
1279700|NCT00273754|Secondary|Hospital Discharge Time|Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.|Total time from end anesthesia to discharge home||||Minutes||Standard Deviation|Mean
1279701|NCT00273754|Secondary|Post Anesthesia Care Unit (PACU) Duration||Time spent in PACU following surgical procedure prior to discharge home or hospital admission.||||minutes||Standard Deviation|Mean
1279702|NCT00273754|Secondary|Awakening Time|A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.|Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.||||Minutes||Standard Deviation|Mean
1279703|NCT00273754|Secondary|Extubation Time.|Time from end of anesthesia until extubation.|Duration from anesthesia end until extubation time.||||minutes||Standard Deviation|Mean
1279704|NCT00273754|Secondary|Occurence of Post Extubatory Respiratory Adverse Events.|The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.|Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.|Per protocol|||Participants|||Number
1279705|NCT00273754|Primary|Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.|The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.|Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.|The analysis was per protocol.|||Participants|||Number
1279706|NCT00273182|Secondary|Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant|"A left ventricular lead related complication is defined as an adverse event that requires invasive intervention or leads to loss of significant device function resulting from the presence or performance of the LV lead.~Kaplan-Meier method was used to estimate complication-free rate during the three years of follow-up. Time to the first post-implant LV lead related complication was used for the calculation. Confidence intervals were calculated on a log-log scale."|36 months follow-up|The analysis included data from all subjects enrolled in the InSync Registry study.|||participants|||Number
1279707|NCT00273182|Secondary|Left Ventricular (LV) Lead Pacing Voltage Threshold|Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up|36 months follow-up||||Volts||95% Confidence Interval|Mean
1279708|NCT00273182|Secondary|Left Ventricular (LV) Lead Impedance|Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.|36 months follow-up||||ohms||95% Confidence Interval|Mean
1279709|NCT00273182|Secondary|Left Ventricular (LV) Lead R-wave Amplitude|Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.|36 month follow-up|1999 subjects successfully implanted with a left ventricular lead as part of a Medtronic CRT/CRT-D system.|||mV||95% Confidence Interval|Mean
1279710|NCT00273182|Primary|Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.|Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules|36 month follow-up|The analysis included data from all subjects enrolled in the InSync Registry study and successfully implanted with the InSync or InSync III system.|||participants|||Number
1279711|NCT00273052|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
1279722|NCT00273052|Secondary|Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6|Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
1279712|NCT00273052|Secondary|Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||Percent Change|||Number
1279713|NCT00273052|Secondary|Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||ng/mL|||Number
1279714|NCT00273052|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||Percent Change|||Number
1279715|NCT00273052|Secondary|Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||uIU/mL|||Number
1279716|NCT00273052|Secondary|Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6|Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||g/L|||Number
1279717|NCT00273052|Secondary|Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6|Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
1279718|NCT00273052|Secondary|Change From Baseline in Weight by Treatment Group at Maintenance Month|Manual physical examination. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||kg|||Number
1279719|NCT00273052|Secondary|Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6|Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||bpm|||Number
1279720|NCT00273052|Secondary|Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6|Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mm Hg|||Number
1279721|NCT00273052|Secondary|Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6|Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mcmol/min/L|||Number
1279723|NCT00273052|Primary|Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6|Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
1279724|NCT00273052|Primary|Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6|Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
1279725|NCT00272987|Secondary|Progression-free Survival as Assessed by the Investigator|Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who do not progress, or die, progression-free survival was censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy. Progression-free survival was summarized using Kaplan-Meier curves.|From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 164)|Safety Population|||Weeks||95% Confidence Interval|Median
1279726|NCT00272987|Secondary|Number of Participants With Clinical Benefit (CR, PR, and Stable Disease [SD] for at Least 24 Weeks) as Assessed by Investigator|Clinical benefit is defined as the numer of participants achieving either a CR or PR or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions), taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR or SD until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 164)|Safety Population|||Participants|||Number
1279727|NCT00272987|Primary|Overall Response (OR): Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 164)|Safety Population|||Percentage of participants|||Number
1279728|NCT00272987|Secondary|Duration of Response (DoR), as Assessed by the Investigator|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 164)|Safety Population. Only those participants with CR or PR were analyzed.|||Weeks||Inter-Quartile Range|Median
1279729|NCT00272987|Secondary|Time to Response as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 164)|Safety Population. Only those participants with CR or PR were analyzed.|||Participants|||Number
1279730|NCT00272987|Primary|Number of Participants Who Received Any Concomitant Medications During the Study Period|Number of participants who received any concomitant medication along with study drugs (lapatinib, trastuzumab and paclitaxel) were counted during the treatment period.|withdrawal/study completion (up to Study Week 164)|Safety Population|||Participants|||Number
1279731|NCT00272987|Primary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value|The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
1279732|NCT00272987|Primary|Number of Events of Left Ventricular Ejection Fraction Decrease With the Indicated Characteristics|Events of left ventricular ejection fraction (LVEF) decrease were characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. A participant could have been counted in more than one category.|Baseline and every 8 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only the participants with at least one of event of LVEF decrease were analyzed.|||Events|||Number
1279733|NCT00272987|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Degree Celsius||Standard Deviation|Mean
1279734|NCT00272987|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute (BPM)||Standard Deviation|Mean
1279735|NCT00272987|Primary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1279736|NCT00272987|Primary|Number of Events of Hepatotoxicity With the Indicated Characteristics|Events of hepatotoxicity are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population. Only the participants with at least one of event of hepatotoxicity were analyzed.|||Events of hepatotoxicity|||Number
1279737|NCT00272987|Primary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters|Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Clinical chemistry parameters included values > upper limit of normal (ULN)=Hyper; values < lower limit of normal (LLN)=Hypo of sodium (Hypernatraemia and Hyponatraemia), potassium (Hyperkalaemia and Hypokalaemia), calcium (Hypercalcaemia and Hypocalcaemia), glucose (Hyperglycaemia and Hyperglycaemia), creatinine (if >2 milligram per deciliter [mg/dL]), aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phophatase, total bilirubin (if available bilirubin fractionation is recommended if the total bilirubin is > twice of ULN), and albumin. Clinical chemistry data was summarized by National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
1279738|NCT00272987|Primary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters|Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Haematology parameters included haemoglobin, total white blood cell count (WBC), neutrophils, lymphocytes and platelets. Hematology data was summarized by the National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population|||Participants|||Number
1279739|NCT00272987|Primary|Number of Events of Diarrhea With the Indicated Characteristics|Events of diarrhea are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population. Only the participants with at least one event of diarrhea were analyzed.|||Events of diarrhea|||Number
1279740|NCT00272987|Primary|Number of Participants Who Died Due to Any Cause|Number of participants who died due to any cause during the study or after completion of study were reported.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population|||Participants|||Number
1279741|NCT00272987|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population|||Participants|||Number
1279742|NCT00272987|Primary|Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel|Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment.|From the date of the first dose of the investigational product up to withdrawal/study completion (up to Study Week 164)|Safety Population: all participants who were randomized and received at least one dose of investigational product.|||Weeks||Standard Deviation|Mean
1279743|NCT00272961|Secondary|Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.|||mmHg||Standard Error|Least Squares Mean
1279744|NCT00272961|Secondary|Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.|||mmHg||Standard Error|Least Squares Mean
1279745|NCT00272961|Secondary|Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.|||mmHg||Standard Error|Least Squares Mean
1279746|NCT00272961|Secondary|Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.|||mmHg||Standard Error|Least Squares Mean
1279747|NCT00272961|Secondary|Standing Diastolic Blood Pressure (DBP)|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.|||mmHg||Standard Error|Mean
1279782|NCT00272779|Secondary|Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96|Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.|||g/cm^2||95% Confidence Interval|Mean
1279970|NCT00270855|Secondary|Lower Limb Bone Mineral Density Between Groups|Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||g*(cm^2)^-1||Standard Deviation|Mean
1279748|NCT00272961|Secondary|Sitting Diastolic Blood Pressure (DBP)|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.|||mmHg||Standard Error|Mean
1279749|NCT00272961|Secondary|Standing Systolic Blood Pressure (SBP)|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.|||mmHg||Standard Error|Mean
1279750|NCT00272961|Secondary|Sitting Systolic Blood Pressure (SBP)|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|Full analysis set (FAS):all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.|||mmHg||Standard Error|Mean
1279751|NCT00272961|Primary|Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change|AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.|Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12|Safety analysis set: all participants who received at least 1 dose of study treatment. “N”(number of participants analyzed): participants evaluable for this measure and n: participants with non-missing baseline and at least 2 non-missing values in treatment phase or in follow-up for specified category for each treatment arm, respectively.|||mmHg||Standard Error|Least Squares Mean
1279752|NCT00272961|Primary|Maximum Blood Pressure (BP) Increase|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.|Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
1279753|NCT00272844|Secondary|Number of Participants With Improved Neuropsychological Development|Improved neuropsychological development is defined as progressively achieving developmental milestones|Every 3-6 months for an approximate median of 5 years||||Participants|||Count of Participants
1279754|NCT00272844|Secondary|Number of Growth Responders|Growth response was defined as an increase in general health, growth, and behavior.|Every 3-6 months for an approximate median of 5 years||||Participants|||Count of Participants
1279755|NCT00272844|Primary|Number of Responders|Responders was defined as an increase in total serum cholesterol and a decrease in 7-DHC (7-Dehydrocholesterol), and 8-DHC (8-Dehydrocholesterol) were measured on all participants.|Every 3-6 months for an approximate median of 5 years||||Participants|||Count of Participants
1279756|NCT00272792|Secondary|Change in Phenylalanine Levels From Baseline to Week 3||Baseline to Week 3||||umol/L||Standard Error|Mean
1279757|NCT00272792|Primary|Amount of Dietary Supplemented Phenylalanine (Phe)Tolerated in Children With Phenylketonuria||at Week 10||||mg/kg/day||Standard Deviation|Mean
1279758|NCT00272779|Primary|Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||cm^2||Standard Error|Mean
1279796|NCT00272779|Primary|Cmax of Tenofovir at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
1279759|NCT00272779|Primary|Mean Change From Baseline in VAT Associated With RETN_730|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||cm^2||Standard Error|Mean
1279760|NCT00272779|Primary|Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||cm^2||Standard Error|Mean
1279761|NCT00272779|Primary|Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||cm^2||Standard Error|Mean
1279762|NCT00272779|Primary|Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||pg/mL||Standard Error|Mean
1279763|NCT00272779|Primary|Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||pg/mL||Standard Error|Mean
1279764|NCT00272779|Primary|Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||ng/dL||Standard Error|Mean
1279765|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
1279766|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
1279783|NCT00272779|Secondary|Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48|Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.|DEXA scans were taken at Baseline (Day 1) and Week 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||grams/ centimeters ^2 (g/cm^2)||95% Confidence Interval|Mean
1279767|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
1279768|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
1279769|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
1279770|NCT00272779|Primary|Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
1279771|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 96|Mean change From baseline in BMI at Week 96 was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and with values for this parameter.|||kg/m^2||Standard Error|Mean
1279772|NCT00272779|Secondary|Mean Changes From Baseline in Body Weight at Week 96|Mean change in body weight from baseline was determined.|Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||kg||Standard Error|Mean
1279773|NCT00272779|Secondary|Percentage of Participants With Lipoatrophy at Week 96|Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||percentage of participants|||Number
1279774|NCT00272779|Secondary|Mean Change From Baseline in Waist-to-hip-ratio at Week 48|Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||ratio||Standard Error|Mean
1279775|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 48|Mean change from baseline in BMI at Week 48 was determined.|Baseline (Day 1) and Week 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||kg/m^2||Standard Error|Mean
1279776|NCT00272779|Secondary|Mean Change From Baseline in Waist-to-hip-ratio at Week 96|Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||ratio||Standard Error|Mean
1279777|NCT00272779|Secondary|Mean Change From Baseline in Waist Circumference at Week 48|Mean change from baseline in waist circumference at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||cm||Standard Error|Mean
1279778|NCT00272779|Secondary|Mean Change From Baseline in Waist Circumference at Week 96|Mean change From baseline in waist circumference at Week 96 was determined.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||cm||Standard Error|Mean
1279779|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 96||Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.|||kg/m^2||Standard Error|Mean
1279780|NCT00272779|Secondary|Mean Change From Baseline in Body Weight at Week 48|Mean change from baseline in body weight at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||kg||Standard Error|Mean
1279781|NCT00272779|Secondary|Mean Change From Baseline in Body Weight at Week 96|Mean change from baseline in weight at Week 96|Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.|||kg||Standard Error|Mean
1279785|NCT00272779|Secondary|Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96|The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||Percentage||95% Confidence Interval|Mean
1279786|NCT00272779|Secondary|Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48|The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.|DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||Percentage||95% Confidence Interval|Mean
1279787|NCT00272779|Secondary|Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.|DEXA scans were taken at Baseline (Day 1) and at Weeks 48.|As-treated participants (with values for this parameter)in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.|||Ratio||Standard Error|Mean
1279788|NCT00272779|Secondary|Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96|Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change|Baseline (Day 1) and Week 96.|"Resistance analysis are based on randomized population. 2 subjects with baseline phenotypic resistance to ATV/RTV are excluded. Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. n signifies the number of participants evaluable for each parameter."|||Participants|||Number
1279789|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
1279790|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
1279791|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96|Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
1279792|NCT00272779|Primary|Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis|19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous].|Baseline visit|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. The Hardy-Weinberg Equilibrium test was used to check for the genotype quality. All SNPs passed the quality check.|||participants|||Number
1279793|NCT00272779|Primary|Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||Ratio||Standard Error|Mean
1279794|NCT00272779|Primary|AUC (TAU) of Tenofovir at Week 4|AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng*h/mL||Full Range|Geometric Mean
1279795|NCT00272779|Primary|Cmin of Tenofovir at Week 4|Cmin was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
1279797|NCT00272779|Primary|Cmin of RTV at Week 4|Cmin was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
1279798|NCT00272779|Primary|AUC (0-24) of RTV at Week 4|AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng*h/mL||Full Range|Geometric Mean
1279799|NCT00272779|Primary|Cmax of RTV at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
1279800|NCT00272779|Primary|Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4|IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
1279801|NCT00272779|Primary|Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4|EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
1279802|NCT00272779|Primary|Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|T-half was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||Hr||Standard Deviation|Mean
1279803|NCT00272779|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|Tmax was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||Hr||Full Range|Median
1279804|NCT00272779|Primary|Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|Cmin was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
1279805|NCT00272779|Primary|Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng*h/mL||Full Range|Geometric Mean
1279806|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96|Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 – 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1–6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
1279807|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96|Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 – 15.0 mg/dL, Grade 4: >15.0 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
1279808|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96|Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279809|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96|Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 – 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 – 5.0* ULN, Grade 4: 5.0* ULN.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
1279810|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96|Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 – 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 – 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279811|NCT00272779|Secondary|Mean Changes in Fasting Insulin at Week 96|Mean change from baseline in fasting insulin at Week 96.|Baseline (Day 1) and Week 96.|Safety analyses of the treatment period are based on treated population with values for this parameter.|||µU/mL||Standard Error|Mean
1279812|NCT00272779|Secondary|Mean Changes in Fasting Glucose at Week 96|Mean change from baseline in fasting glucose at Week 96 was determined.|Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.|||mg/dL||Standard Error|Mean
1279813|NCT00272779|Primary|Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.|All participants who completed the intensive pharmacokinetic (PK) study.|||nanogram(ng)/mL||Full Range|Geometric Mean
1279814|NCT00272779|Secondary|Mean Changes in Fasting Lipids at Week 96|Mean change from baseline in fasting lipids at Week 96 was determined.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||mg/dL||Standard Error|Mean
1279815|NCT00272779|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96|AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|From Day 1 through Week 96|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
1279816|NCT00272779|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 96|Mean change from baseline in CD4 count among treated participants was determined.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter.|||cells/mm^3||Standard Error|Mean
1279817|NCT00272779|Secondary|Reduction of log10 HIV RNA Levels From Baseline at Week 96|Changes from baseline in log10 HIV RNA levels were calculated.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter. log10 HIV RNA changes from baseline were summarized at Week 96 using observed values.|||c/mL||Standard Error|Mean
1279818|NCT00272779|Secondary|Number of Participants With HIV RNA < 400 c/mL) at Week 96|HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.|||Participants|||Number
1279819|NCT00272779|Secondary|Number of Participants With HIV RNA < 50 c/mL) at Week 96|HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.|||Participants|||Number
1279820|NCT00272779|Secondary|Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48|The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Week 48|The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279832|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48|Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279821|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|Baseline (Day 1) and Week 24|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Error|Mean
1279822|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|IBS-QoL is administered at baseline (Day 1) and Week 12.|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.|||Units on Scale||Standard Error|Mean
1279823|NCT00272779|Secondary|Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|IBS-QoL is administered at baseline (Day 1) and Week 4.|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.|||Units on Scale||Standard Error|Mean
1279824|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48|MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.|Baseline (Day 1) and Week 48|Participants analyzed are as-treated participants with evaluable baseline MOS-HIV. The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.|||Units on Scale||Standard Error|Mean
1279825|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24|Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.|Baseline (Day 1) and Week 24.|As-treated participants with evaluable baseline MOS-HIV . The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.|||Units on Scale||Standard Error|Mean
1279826|NCT00272779|Secondary|Mean Change in Fasting Insulin at Week 48|Mean change from baseline in fasting insulin at Week 48.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population with values for this parameter.|||micro units (µU)/mL||Standard Error|Mean
1279827|NCT00272779|Secondary|Mean Change in Fasting Glucose at Week 48|Mean change from baseline in fasting glucose at Week 48.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population with values for this parameter.|||mg/dL||Standard Error|Mean
1279828|NCT00272779|Secondary|Mean Change in Fasting Lipid at Week 48|Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population.|||milligrams/deciliter (mg/dL)||Standard Error|Mean
1279829|NCT00272779|Secondary|Mean Change in Body Mass Index (BMI) in Participants at Week 48|Mean change in BMI from baseline at Week 48 was determined.|Baseline (Day 1) and Week 48|Safety analyses of the treatment period are based on treated population, who had values for this parameter.|||kg/m^2||Standard Error|Mean
1279830|NCT00272779|Secondary|Mean Change in Weight From Baseline at Week 48|Mean change in body weight from baseline was determined.|Baseline (Day 1) and Week 48|Safety analyses of the treatment period are based on treated population, who had values for this parameter.|||kg||Standard Error|Mean
1279831|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279842|NCT00272779|Secondary|Reduction of log10 HIV RNA Levels From Baseline to Week 48|Changes from baseline in log10 HIV RNA levels were calculated.|Baseline (Day 1) and Week 48|All treated participants with data for this parameter.|||c/mL||Standard Error|Mean
1279833|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279834|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48|Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 – 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1–6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279835|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48|Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 – 15.0 mg/dL, Grade 4: >15.0 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279836|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48|Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279837|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48|Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 – 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 – 5.0* ULN, Grade 4: 5.0* ULN.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279838|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)|Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 – 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 – 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279839|NCT00272779|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48|AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|From baseline (Day 1) to Week 48.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
1279840|NCT00272779|Secondary|Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48|Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change|Baseline (Day 1) and Week 48|Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
1279841|NCT00272779|Secondary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48|Mean change from baseline in CD4 cell counts was determined.|Baseline (Day 1) and Week 48.|All treated participants with data for this parameter.|||c/mm^3||Standard Error|Mean
1279843|NCT00272779|Secondary|Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)|TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.|Baseline (Day 1) and Week 48|Efficacy analyses of the treatment period are based on randomized population.|||Participants|||Number
1279844|NCT00272779|Secondary|Number of Participants With HIV RNA < 400 c/mL at Week 48|HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.|Baseline (Day 1) and Week 48|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under Non-completers.|||Participants|||Number
1279845|NCT00272779|Primary|Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48|HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.|Baseline (Day 1) and Week 48|Intent-to-treat (ITT) analysis. Participants received treatment assignment from the central randomization center. In this analysis, participants who did not complete the study were counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under non-completers.|||Participants|||Number
1279846|NCT00272337|Other Pre-specified|Change in Platelet Biomarkers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)|At the conclusion of the trial in 2010, due to lack of funds for analysis, analysis was not conducted.||||||
1279847|NCT00272337|Other Pre-specified|Change in Inflammatory Markers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)|At the conclusion of the trial in 2010, due to lack of funds for analysis, analysis was not conducted.||||||
1279848|NCT00272337|Primary|Change in Nitric Oxide Formation From Baseline to 3 Months.|Heme oxygenase a downstream target of nitric oxide formation|Baseline to 3 Months (90-97 days)|Complete baseline and follow-up data|||ng/mL||Standard Deviation|Mean
1279849|NCT00272311|Primary|Change in Nitric Oxide Formation From Baseline to 3 Months|Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.|Baseline to 3 Months (90-97 days)|Complete baseline and follow-up data|||ng/mL||Standard Deviation|Mean
1279850|NCT00272168|Primary|Employment Status|Data collected included from participants: weekly wages earned|Post Treatment (approximately 3 months after completion of the baseline assessment)||||dollars/week||Standard Deviation|Mean
1279851|NCT00272168|Primary|Social Functioning|"This was assessed using the Maryland Assessment of Social Competence (MASC), which assesses participants social problem solving skill abilities in both work-related and non-work related situations. Using three scenes, the participant is rated on the following scale for each scene. Overall score is then averaged to arrive at a final score.~Very Poor~Poor~Neither good nor poor~Somewhat good~Very good"|Post Treatment||||units on a scale||Standard Deviation|Mean
1279852|NCT00272168|Primary|Work Performance (Work Behavior Inventory)|"This measure is completed with participants' supervisors and assesses current work behavior and vocational function. The WBI yields six scores related to fundamental work requirements: social skills, cooperativeness, work habits, work quality personal presentation, and a general score of overall work performance. Each of these is rated between 1-5:~Consistently an area Needing Improvement~Occasionally an area Needing Improvement~Performance Adequate in this area~Occasionally an area of Superior Performance~Consistently an area of Superior Performance.~The global impression of work behavior (overall rating of work functioning using the same 1-5 scale) was used for the purpose of reporting results for this study."|Post Treatment||||rating on a scale||Standard Deviation|Mean
1279853|NCT00272168|Secondary|Psychiatric Symptoms|Psychiatric Symptoms were assessed using the Brief Psychiatric Rating Scale (BPRS), a widely used instrument for assessing the positive, negative, and affective symptoms of individuals who have mental illnesses. The BPRS consists of 20 symptom constructs scored from 1 (not present) to 7 (extremely severe). BPRS total score could range from 0 (not present) to 140 (extremely severe).|Post-Treatment||||scores on a scale||Standard Deviation|Mean
1279854|NCT00272168|Secondary|Cognitive Insight|"Cognitive insight was assessed using the Beck Cognitive Insight Scale, a 15-item questionnaire developed to evaluate patients' self-reflectiveness and their overconfidence in their interpretations of their experiences. Participant responses to each of these items were as follows:~Do not agree at all~Agree slightly~Agree a lot~Agree completely~Total score for the self-certainty scale could range from 6 to 24. Total score for the self-reflectiveness scale could range from 9 to 36. Total score for the composite score was calculated by subtracting the summed score for the self-certainty scale from the summed score of the self-reflectiveness scale and could range from 3 to 12, lower composite scores are an indicator of lower psychiatric functioning."|Post Treatment||||units on a scale||Standard Deviation|Mean
1279855|NCT00272168|Primary|Employment Status|Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.|Post Treatment (approximately 3 months after completion of the baseline assessment)||||Hours worked per week||Standard Deviation|Mean
1279856|NCT00272038|Secondary|Time to Disease Progression|"Patients were evaluated for response biochemically and radiographically at each response assessment. RECIST 1.0 criteria were used for radiographic response. PSA measurement at a central laboratory was used to assess biochemical response. Patients must have had a baseline PSA of 5 ng/ml to be evaluated for PSA response. PSA was measured every 8 weeks.~For patients with measurable disease radiographically, PSA progression was not considered as having progressive disease. Refer to study publication for details."|25 months|29 participants enrolled. only 22 were evaluable, 4 withdrew consent, 2 had rapid PSA increase & 1 had cord compression|||months||Full Range|Median
1279857|NCT00272038|Secondary|Overall Survival|One year survival rate.|during study||||% of partcipants alive at one year|||Number
1279907|NCT00271544|Secondary|All Left Ventricular Leads|All left ventricular leads successfully implanted|Implant|Subjects who underwent an implant attempt.|||participants|||Number
1279858|NCT00272038|Primary|Overall Clinical Benefit of Tarceva in CRPC.|Overall Clinical Benefit = percentage of partial responders (PR)+ the percentage of patients with stable disease (SD). Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease (SD)is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0).|5 years||||percentage of pts w/clinical benefit|||Number
1279859|NCT00271947|Primary|Number of Participants With Remission or Clinical Improvement as Assessed by Crohn's Disease Activity Index (CDAI) Scores|Clinical remission defined as a CDAI less than 150 and clinical improvement defined as decline in CDI> or = 70 one year following entry. The participant was not assessed according to the criteria of the outcome measure, because the participant was lost for follow-up.|baseline|||||||
1279860|NCT00271856|Primary|Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)|We used the Patient Health Questionnaire (PHQ-9) as a measure of depressive symptom severity. The PHQ-9 is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument. Participants rate the frequency of 9 depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.|baseline to 12 months|ITT analyses.|||scores on the scale||95% Confidence Interval|Mean
1279861|NCT00271856|Primary|Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score|Emotion was assessed with the Positive and Negative Affect Schedule (PANAS\). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Negative Affect (NA) score is derived from summing the scores on the 10 negative emotions. Scores on the NA subscale range from 0-40, with higher scores reflecting more negative affect over the past week.|baseline to 12 months|ITT analyses.|||scores on the scale||95% Confidence Interval|Mean
1279862|NCT00271856|Primary|Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score|Emotion was assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Positive Affect (PA) score is derived from summing the scores on the 10 positive emotions. Scores on the PA subscale range from 0-40, with higher scores reflecting more positive affect over the past week.|baseline to 12 months|ITT analyses|||scores on the scale||95% Confidence Interval|Mean
1279863|NCT00271856|Primary|Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)|Perception of stress was measured with the 10-item version of the Perceived Stress Scale. This widely used measure of perceived stress was designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate how often they felt or thought a certain way over the past month on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.|baseline to 12 months|ITT analyses.|||scores on the scale||95% Confidence Interval|Mean
1279864|NCT00271856|Primary|Change in Depression as Measured by Beck Depression Inventory (BDI)|The BDI is a widely used outcome measure for studies of depression. The BDI consists of 21 items that are rated on a 4-point scale according to how severely they are experienced. Scores range from 0-63, with higher scores reflecting greater depression.|baseline to 12 months|ITT analyses.|||scores on the scale||95% Confidence Interval|Mean
1279865|NCT00271856|Primary|Change in CD4 T-cell Count||baseline to 12 months|Intent to treat (ITT) analyses. Multiple imputation method used for those who started antiretroviral therapy (ART) between 0 and 12 months.|||cells/µl||95% Confidence Interval|Mean
1279866|NCT00271856|Secondary|Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging||3, 6, and 12 months|||||||
1279867|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Error|Mean
1279868|NCT00271817|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Error|Mean
1279869|NCT00271817|Secondary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Error|Mean
1279870|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Error|Mean
1279871|NCT00271817|Secondary|Percent Change From Baseline in Triglycerides (TG)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Deviation|Median
1279872|NCT00271817|Secondary|Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Error|Mean
1279873|NCT00271817|Secondary|Percent Change From Baseline in Triglycerides (TG)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline|baseline and 24 Weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Deviation|Median
1279874|NCT00271817|Secondary|Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Error|Mean
1279875|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Error|Mean
1279876|NCT00271817|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline|Baseline and 24 Weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Error|Mean
1279877|NCT00271739|Primary|Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol||5 years||||mg/dL||Standard Error|Mean
1279878|NCT00271739|Primary|Blood Pressure Levels||5 years||||mmHg||Standard Error|Mean
1279879|NCT00271739|Primary|Hemoglobin A1c Levels||5 years||||A1c percentage||Standard Error|Mean
1279880|NCT00271609|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years||||Participants|||Number
1279881|NCT00271609|Primary|Percentage of Participants With Progression Free Survival at 6 Months.|Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.|6 months|at the time of data cutoff for this endpoint, 31 patients in the AG arm and 48 patients in the GBM arm were evaluable for PFS.|||Percentage of participants||95% Confidence Interval|Number
1279882|NCT00271596|Secondary|Subgroup Analysis of the Hamilton Depression Rating Scale Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|||units on a scale||Standard Error|Least Squares Mean
1279883|NCT00271596|Secondary|Total Functional Capacity Score Comparing Baseline (Week -4) to Visits 4 (Week 6) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Total Functional Capacity (TFC) subscale from the Unified Huntington’s Disease Rating Scale (UHDRS). Definition: The TFC is a score that classifies five stages of Huntington's Disease and five levels of function in the domains of workplace, finances, domestic chores, activities of daily living and requirements for unskilled or skilled care. Construct Measured: Activities of Daily Living. Scale Range: The TFC score ranges from 0 to 13, where lower scores indicate poorer performance in activities of daily living. Change Calculation Details: Compares change in TFC performance from Baseline (week -4) to the weighted average of visits 4 (week 6) and 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model comparing baseline (week -4) to the weighted average of Visits 4 (week 6) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279884|NCT00271596|Secondary|Hamilton Rating Scale for Depression Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: Compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model comparing screening (intake visit) to Visit 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279885|NCT00271596|Secondary|Trails B Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Trail Making Test Part B (TMT-B). Definition: The TMT-B test requires participants to “connect-the-dots” of 25 consecutive targets on a sheet of paper where the subject alternates between numbers and letters, going in both numerical and alphabetical order. Constructs Measured: Attention, set shifting, and processing speed. Scale range: The TMT-B score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279886|NCT00271596|Secondary|Stroop Interference Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|"Full Scale Name: Stroop Interference subtest from The Stroop Color and Word Test. Definition: Participants are asked to name the ink color in which a word is printed when the word itself (which is irrelevant to the task) is the name of a different color rather than the same color. For example, participants may be asked to say red to the word blue printed in red ink. Constructs Measured: Selective attention, response inhibition, cognitive flexibility, and processing speed. Scale Range: The Stroop Interference score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort."|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279887|NCT00271596|Secondary|Verbal Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Verbal Fluency Score (VFC). Definition: The VFC is the number of words a person can produce given a letter, including (1) Naming words that start with F, A, and S; (2) naming words that start with K, W, and R; (3) naming words that start with V, I, and P; (4) naming words that start with O, G, and B; (5) naming words that start with E, N, and T; and (6) naming words that start with J, C, and S. Construct Measured: Verbal initiation and flexibility. Scale Range: The Verbal Fluency Composite Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in verbal initiation and flexibility from visit 2 (week 0) where patients named words starting with O, G, and B to the weighted average of visits 5 (week 12) and 6 (week 15) where patients named words starting with E, N, and T, and J, C, and S respectively for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279888|NCT00271596|Secondary|Symbol-Digit Modalities Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Symbol Digit Modalities Test (SDMT). Definition: The SDMT screens for organic cerebral dysfunction by having the examinee use a reference key to pair specific numbers with given geometric figures in 90 seconds. Construct Measured: Attention, processing speed, and working memory. SDMT Scale Range: Raw scores may range from 0 to 110, where lower scores indicate poorer performance. Change Calculation Details: Compares change in performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279889|NCT00271596|Secondary|Semantic Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Semantic Fluency Score. Definition: The Semantic Fluency Score is the number of words a person can produce given a category, including naming (1) Animal names, (2) Fruit names, (3) Boy names, (4) Girl names, and (5) Vegetable names. Construct Measured: Working memory and verbal initiation. Scale Range: The Semantic Fluency Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on working memory tasks. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) where patients named fruit names to the weighted average of visits 5 (week 12) & 6 (week 15) where patients named girl names and vegetable names respectively for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279908|NCT00271544|Secondary|Subjects Successfully Implanted After Cannulation|A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.|Implant|Subjects with successful CS cannulation after an incision was made (implant attempt)|||participants|||Number
1283074|NCT00233090|Primary|Fatigue|Self-report of fatigue|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
1279890|NCT00271596|Secondary|Letter Number Sequencing Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Letter Number Sequencing (LNS) subtest from the Wechsler Adult Intelligence Scale (WAIS) third edition. Definition: LNS is a task that requires the reordering of an initially unordered set of letters and numbers. Construct Measured: Working memory. LNS Score Range: Raw scores may range from 0 to 21, where lower scores indicate poorer performance in working memory. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279891|NCT00271596|Primary|Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort.|Full Scale Name: The Executive Composite Score (ECS). Definition: Subscales were averaged to compute this composite total score. The ECS is the weighted average of performance on 6 subtests of executive function, including (1) the Controlled Oral Word Association Test, (2) Symbol Digit Modalities test; (3) Stroop Color Word Test (Interference Trial), (4) Trail Making test (Part B), (5) Letter-Number Sequencing, and (6) Animal Naming. Construct Measured: Thinking tasks involving planning, working memory, attention, problem solving, verbal reasoning, inhibition, mental flexibility, and task switching. ECS Scale Range: The ECS score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on executive functioning tasks. Change Calculation Details: Compares change in executive functioning performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
1279892|NCT00271570|Primary|Area Under the Curve of Infliximab Concentration Before Infliximab Infusion and Then 2 and 24 Hours, 1 Week (5 to 9 Days), 2 Weeks (12 to 16 Days), and 4 Weeks (26 to 30 Days) After Infliximab Infusion)|The area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last) was estimated using the trapezoidal rule up to the last measurable concentration.Samples were collected before infliximab infusion and then at 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion. Subjects with detectable infliximab concentrations at week 4 had another sample drawn at week 10 (68 to 72 days).|before infliximab infusion and then 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion.||||micogram*day/ml||Inter-Quartile Range|Median
1279893|NCT00271570|Primary|Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)|The safety of giving infliximab to treat IVIG-resistant Kawasaki disease was measured by recording the number of adverse events that occurred in each group. An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of either IVIG or infliximab, regardless of whether it was considered related to IVIG or infliximab, that occured during the course of this study.In particular we evaluated for AEs related to side effects from infliximab or IVIG.|2 weeks||||events|||Number
1279894|NCT00271544|Secondary|Summarize All Adverse Events|All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu|Up to 18 months|All subjects enrolled into the 4196 study.|||adverse events|||Number
1279895|NCT00271544|Secondary|Electrical Performance -Ring Electrode: Pacing Impedance|Model 4196 lead ring electrode pacing impedance|12-Month|Subjects with Model 4196 lead implanted and completed 12-month visit.|||Ohms||Standard Deviation|Mean
1279896|NCT00271544|Secondary|Electrical Performance - Ring Electrode: LV Voltage Threshold|Model 4196 lead ring electrode LV voltage threshold|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.|||Volts||Standard Deviation|Mean
1279897|NCT00271544|Secondary|Electrical Performance -Ring Electrode: Sensing|Model 4196 lead ring electrode R-wave amplitude|Implant|Subjects with Model 4196 lead implanted and with intrinsic R-wave amplitude at implant.|||mV||Standard Deviation|Mean
1279898|NCT00271544|Secondary|Electrical Performance -Tip Electrode: Pacing Impedance|Model 4196 lead tip electrode pacing impedance|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.|||Ohms||Standard Deviation|Mean
1279899|NCT00271544|Secondary|Electrical Performance - Tip Electrode: LV Voltage Threshold|Model 4196 lead tip electrode LV voltage threshold|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.|||Volts||Standard Deviation|Mean
1279900|NCT00271544|Secondary|Electrical Performance - Tip Electrode: Sensing|Model 4196 lead tip electrode R-wave amplitude|12-month|Subjects with Model 4196 lead implanted and an intrinsic R-wave available at 12-month visit.|||millivolt (mV)||Standard Deviation|Mean
1279901|NCT00271544|Secondary|Assessment of Lead Handling Characteristics|"Lead handling characteristics assessed as acceptable by physicians"|Implant|All available assessments from physicians.|||participants|||Number
1279902|NCT00271544|Secondary|Total Implant Time|Total implant time was defined as time from initial incision to final closure.|Implant|Subjects successfully implanted with a Model 4196 lead.|||minutes||Standard Deviation|Mean
1279903|NCT00271544|Secondary|Model 4196 Lead Placement Time|Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.|Implant|Subjects successfully implanted with a Model 4196 lead.|||minutes||Standard Deviation|Mean
1279904|NCT00271544|Secondary|Fluoroscopy Time|Fluoroscopy time was defined as the total time the fluoroscope was imaging.|Implant|Subjects successfully implanted with a Model 4196 lead.|||minutes||Standard Deviation|Mean
1279905|NCT00271544|Secondary|Cannulation Time|Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.|Implant|Subjects successfully implanted with a Model 4196 lead.|||minutes||Standard Deviation|Mean
1279906|NCT00271544|Secondary|All Medtronic Left Ventricular Leads (Attain Family)|All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted|Implant|Subjects who underwent an implant attempt.|||participants|||Number
1279912|NCT00271544|Primary|Safety (Subjects Without a Model 4196 Lead Related Complication)|A subject who was free of a Model 4196 lead related complication by one month visit.|One Month|Subjects who underwent a Model 4196 left ventricular (LV) lead implant attempt and completed 1-month visit; or experienced Model 4196 lead related complications by 1-month visit.|||participants|||Number
1279913|NCT00271375|Secondary|Perceived Social Support|Caregiver Perceived Social Support was assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS) a 19-item scale that taps perceived emotional/informational, tangible, and affectionate support, and positive social interaction based on a 5-point likert scale with (1 = None of the time and 5= All of the time) with total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279914|NCT00271375|Secondary|Personal Mastery|Caregiver Personal Mastery was assessed using the Personal Mastery Scale which afforded a general measure of self-perceived ability to manage stressors and effect change in one's life through a 7-item question based on a 5-point likert scale with (5 = Agree A lot and 1= Disagree A lot) and a total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279915|NCT00271375|Secondary|Caregiver Efficacy|Caregiver Efficacy was assessed using the RIS Eldercare Self Efficacy Scale (RIS) a 10-item inventory addressing family caregiver's perception of their own ability to manage care provision challenges in the areas of relationship with the care recipient, instrumental care provision, and self-soothing (managing the strains of care provision) based on a 5-point likert scale with (1 = Im certain I CANNOT Do This and 5= Im certain I CAN Do This) with a total score range between1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279916|NCT00271375|Secondary|Caregiver Mastery|Caregiver Mastery was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through a 4-item question assessing a sense of doing a good job of care provision based on a 5-point likert scale with (5= Agree A lot and 1= Disagree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 5 to 20 were calculated, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Median
1279917|NCT00271375|Secondary|Caregiver Satisfaction|Caregiver Satisfaction was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 6-items based on a 5-point likert scale with (1 = Disagree A lot and 5= Agree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 6 to 30 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279918|NCT00271375|Secondary|Caregiver Burden|Caregiver Burden was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 9-items based on a 5-point likert scale with (1 = Never and 5= Nearly always). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 9 to 45 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279919|NCT00271375|Secondary|Depressive Symptoms|Depression symptoms were assessed using the Center for Epidemiological Studies Depression Scale (CES-D Short Form). The CES-D is a 10 Question Scale with total scores ranging from 0-30. Mean scores were calculated by finding the total sum divided by the total number of participants. Any score equal to or above 10 is considered depressed. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279920|NCT00271375|Secondary|Physical Function|Physical function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which is represented by 10 items tapping basic functional abilities of the caregiver (Does their health limit them in the following activities). 10 items were scored on a 3-Point Likert Scale with 1= Limited A lot and 3= Not Limited and total scale range between 1 and 3. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279921|NCT00271375|Secondary|Physical Role Function|Physical Role Function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at how emotional or physical issues interfered with everyday social roles of the caregiver. 4 items were scored on a 5-point Likert scale (1 = All of the time and 5= None of the time) with total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279963|NCT00270855|Other Pre-specified|Change in Resting Metabolic Rate|Change in resting metabolic rate after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||kcal/day||Standard Deviation|Mean
1279922|NCT00271375|Secondary|Subjective Health|Subjective Health was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at the how the respondent (caregiver) perceived their own health currently and compared to a year ago. Two items were based on a 5-point Likert scale (1 =Excellent and 5= Poor) with a total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total number of items, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
1279923|NCT00271375|Primary|"To Evaluate User Satisfaction With and Perceived Utility of the Caring for You, Caring for Me Caregiver Educational Program Among Formal (VHA Staff) and Informal (Family) Caregivers Who Undergo the Program"|This question addresses user satisfaction, in terms of caregiving perceived utility of the education program, as well as their actual use of knowledge and skills gained in their caregiving situation.|18 Months|"User evaluation of the Caring for you, Caring for me education program. Data for participants in the Caring for you, Caring for me education program only and Caring for you, Caring for me education program+ Social Work were combined during data collection. Only 71 participants provided results. No data was collected from control group."|||participants|||Number
1279924|NCT00271219|Secondary|Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score|The Addiction Severity Index is a structured clinical interview that assesses problem severity in 7 areas of functioning: alcohol use, drug use, medical, legal, employment, psychosocial, and psychiatric status. Each area of functioning yields a composite scale score between 0 and 1, with higher scores indicating greater problem severity in that area. Only the psychosocial index was examined in this study.|at delivery||||Score on the scale||95% Confidence Interval|Mean
1279925|NCT00271219|Secondary|Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)|Pregnant women maintained on an opioid agonist medication may require upward adjustment to their medication during the course of pregnant. The Dose Adequacy Measure represented a recordation of dosing adjustments during the course of the study.|from study entry until discontinuation or delivery (min=29 days, max=239 days)|intra-subject variability in dosing (typically 1 dose) over course of the trial was too small to estimate the parameter of interest with sufficient accuracy|||dose increase per trimester|||Number
1279926|NCT00271219|Secondary|Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)||monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)|frequency of occurrence too low to be estimated with accuracy|||percentage of HIV risk behaviors|||Number
1279927|NCT00271219|Secondary|Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)||monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)|frequency of use during the course of the study was too low to estimate the parameter with sufficient accuracy|||percentage of drug use|||Number
1279928|NCT00271219|Primary|Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS|Total amount in mg|Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)||||mg||95% Confidence Interval|Mean
1279929|NCT00271219|Primary|Child's Peak Daily Total NAS Score|NAS was measured with the MOTHER NAS scale, which includes 28 items, 19 of which are used for scoring and medication decisions. Scores can range from 0 to 42, with higher scores indicating more severe withdrawal.|minimum twice daily from birth until NAS no longer measured (min=10 days)||||Score on the scale||95% Confidence Interval|Mean
1279930|NCT00271219|Primary|Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)|Neonatal abstinence syndrome (NAS) characterized by hyperirritability of the central nervous system and dysfunction in the autonomic nervous system, gastrointestinal tract, and respiratory system.11 When left untreated, NAS can result in serious illness (e.g., diarrhea, feeding difficulties, weight loss, and seizures) and death.|From birth until hospital discharge (min=4 days, max=10, depending on site)||||participants|||Number
1279931|NCT00271219|Primary|Child's Length of Hospital Stay||delivery until hospital discharge (min=2 days, max=79 days)||||days||95% Confidence Interval|Mean
1279932|NCT00271219|Primary|Child's Head Circumference Measurement (Measured at Birth)||birth||||cm||95% Confidence Interval|Mean
1279933|NCT00271154|Primary|Percentage of Patients Worsened for Clinical Composite Response|Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.|12 Months|All randomized patients were included using Intent to Treat (ITT).|||Percentage of participants worsened|||Number
1279934|NCT00271154|Secondary|Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)|The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.|Baseline to 12 months||||milliliters per meters squared||Standard Deviation|Mean
1279935|NCT00271024|Secondary|Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date|Participants reporting side effects during the previous week by pill type and sex, 4-weeks following quit date (Study week 7). Participants rated side effects experienced by None, Mild, or Severe.|4-Weeks Post Quit Date (Study Week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.|||Participants|||Number
1279936|NCT00271024|Secondary|Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date|Participants reporting side effects during the previous week by pill type and sex, 1-week following quit date (Study week 4). Participants rated side effects experienced by None, Mild, or Severe.|1-Week Post Quit Date (Study Week 4)|All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.|||Participants|||Number
1279964|NCT00270855|Secondary|Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups|Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Ratio||Standard Deviation|Mean
1279937|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|52 Weeks Following Smoking Quit Date (Study week 55)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
1279938|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|26 Weeks Following Smoking Quit Date (Study week 29)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
1279939|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|12 Weeks Following Smoking Quit Date (Study week 15)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
1279940|NCT00271024|Secondary|Weight Change at End of Treatment (Regardless of Quit Status)|Weight change at 12 weeks post quit date (study week 15) for the whole sample regardless of quit status. All data is Mean(SEM) and represents a positive change unless otherwise noted.|Weight change at 12 weeks post quit date (study week 15) from smoking quit date|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome, regardless of their abstinence status at 12 weeks post quit date (study week 15)|||Pounds||Standard Error|Mean
1279941|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|4 Weeks Following Smoking Quit Date (Study week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
1279942|NCT00271024|Primary|Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date|Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.|12 Weeks Following Smoking Quit Date (Study week 15)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
1279943|NCT00271024|Secondary|Weight Change at End of Treatment (Smoking Abstinent Only)|Weight change in lbs at 12 weeks post smoking quit date (study week 15) for only those reporting continued smoking abstinence at the end of treatment. All data are Mean(SEM) and represent positive change, unless otherwise noted. Smoking abstinent for this measure defined as no smoking even 1 puff of a cigarette since the smoking quit date (study week 3), allowing for a 1-week grace period.|Weight change at 12 weeks post smoking quit date (study week 15)|All participants completing through smoking quit date (study week 3) and who were smoking abstinent at end of treatment (study week 15)|||Pounds||Standard Error|Mean
1279944|NCT00271024|Primary|Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date|Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.|4 Weeks Following Smoking Quit Date (Study week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
1279945|NCT00271011|Secondary|Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events|The proportion of patients experiencing hematological and non-hematological toxicities will be summarized.|2 months|The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution. Since accrual was not completed the proportion of patients experiencing toxicities could not be statistically determined.||||||
1279946|NCT00271011|Primary|Percentage of Patients With an Objective Response|The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a decrease in the sum of the longest diameter of target lesions by at least 30% for at least 4 weeks without the appearance of any new lesions.|2 months|The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution.||||||
1279947|NCT00270998|Secondary|Satisfaction With Treatment at 12 Months|"Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise."|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.|||Participants|||Count of Participants
1279948|NCT00270998|Secondary|Satisfaction With Treatment at 3 Months|"Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise."|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.|||Participants|||Count of Participants
1279949|NCT00270998|Secondary|75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months|Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.|||Participants|||Count of Participants
1279950|NCT00270998|Secondary|75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months|Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.|||Participants|||Count of Participants
1279951|NCT00270998|Secondary|No Bothersome Stress Incontinence Symptoms at 12 Months.|Success if participants answer either “no” or “yes” with a bother component of “not at all” or “somewhat” to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.|||Participants|||Count of Participants
1279952|NCT00270998|Secondary|“Much Better” or “Very Much Better” on PGI-I at 12 Months|PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from “not at all” to “very much better.” Participants were considered a success if they responded “much better” or “very much better,” or a failure if they responded otherwise.|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.|||Participants|||Count of Participants
1279953|NCT00270998|Primary|No Bothersome Stress Incontinence Symptoms at 3 Months|Success if participants answer either “no” or “yes” with a bother component of “not at all” or “somewhat” to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.|||Participants|||Count of Participants
1279954|NCT00270998|Primary|“Much Better” or “Very Much Better” on PGI-I at 3 Months|PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from “not at all” to “very much better.” Participants were considered a success if they responded “much better” or “very much better,” or a failure if they responded otherwise.|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.|||Participants|||Count of Participants
1279955|NCT00270894|Secondary|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|Measured from day 1 of treatment until time of death, assessed up to 48 months.||||Months||95% Confidence Interval|Median
1279956|NCT00270894|Secondary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.||||Months||95% Confidence Interval|Median
1279957|NCT00270894|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up.|At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36|Note that the number of participants analyzed changes with the study interval. At Screening n=30, after Epirubicin/Cyclophosphamide n=30, Pre-surgery n=28, Follow-up Month 6 n=28, Follow-up Month 12 n=20, Follow-up Month 24 n=9, and Follow-up Month 36 n=1.|||LVEF percent||Standard Deviation|Mean
1279958|NCT00270894|Secondary|Clinical Response Prior to Surgery|Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters.|Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.|Clinical response assessment was available for 27 patients at the time of surgery.|||Participants|||Number
1279959|NCT00270894|Secondary|Pathologic Response|Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters.|At completion of neoadjuvant treatment period, up to 24 weeks.|28 patients went to surgery, so 28 patients were included in the surgery sample. Note that 4 patients in the pathologic complete response (pCR) group had residual ductal carcinoma in situ (DCIS).|||Participants|||Number
1279960|NCT00270894|Primary|Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities|Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.|Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.||||Events|Participants||Number
1279961|NCT00270894|Primary|Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule|Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.|From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)||||percentage of participants|||Number
1279962|NCT00270855|Other Pre-specified|Resting Metabolic Rate Between Groups|Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||kcal/day||Standard Deviation|Mean
1279971|NCT00270855|Secondary|Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)|Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|Baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Ratio||Standard Deviation|Mean
1279972|NCT00270855|Secondary|Change in Total Cholesterol (TC)|Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
1279973|NCT00270855|Secondary|Change in Low Density Lipoprotein Cholesterol (LDL)|Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
1279974|NCT00270855|Secondary|Change in High Density Lipoprotein Cholesterol (HDL)|Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
1279975|NCT00270855|Secondary|Change in Triglycerides|Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
1279976|NCT00270855|Secondary|Change in Lower Limb Bone Mineral Content|Change in lower limb bone mineral content after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||grams||Standard Deviation|Mean
1279977|NCT00270855|Secondary|Change in Lower Limb Bone Mineral Density|Change in lower limb bone mineral density after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||g*(cm^2)^-1||Standard Deviation|Mean
1279978|NCT00270855|Primary|Glucose Effectiveness (Sg) Between Groups|Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||min^-1||Standard Deviation|Mean
1279979|NCT00270855|Primary|Insulin Sensitivity (Si) Between Groups|Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||min^-1||Standard Deviation|Mean
1279980|NCT00270855|Primary|Fat Free Mass Between Groups|Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||kg||Standard Deviation|Mean
1279981|NCT00270855|Primary|Fat Mass Between Groups|Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||kg||Standard Deviation|Mean
1279982|NCT00270855|Primary|%Body Fat Between Groups|Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Percent Body Fat||Standard Deviation|Mean
1279983|NCT00270855|Primary|Change in Insulin Sensitivity (Si)|Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|Baseline, 16-weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||min^-1||Standard Deviation|Mean
1279984|NCT00270855|Primary|Change in Glucose Effectiveness (Sg)|Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|Baseline, 16-weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||min^-1||Standard Deviation|Mean
1279985|NCT00270855|Primary|Change in Fat-Free Mass|Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Kg||Standard Deviation|Mean
1279986|NCT00270855|Primary|Change in Fat Mass|Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|Baseline, 16 Weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Kg||Standard Deviation|Mean
1279987|NCT00270855|Primary|Change in % Body Fat|Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Percent Body Fat||Standard Deviation|Mean
1279988|NCT00270842|Secondary|Fall Self Efficacy|Fall Self Efficacy is operationalized as perceived self efficacy (i.e. self confidence) for avoiding a fall during 10 global, relatively non-hazardous activities of daily living (getting dressed and undressed, for example). Fall self efficacy manifests itself with different degrees of fear of falling, each with a unique associated risk level. The MFES is simple, quick, easy-to-administer scale that assesses a patient’s self-reported ability to perform, without falling, each of 14 common activities of daily living in a Likert scale format. Total scale ranges from 0 to 140, the higher score indicated more confidence in ability to manage a fall.|10 weeks||||units on a scale||Standard Deviation|Mean
1279989|NCT00270842|Primary|Gait and Balance Measures|The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject’s ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.|10 weeks||||units on a scale||Standard Deviation|Mean
1280509|NCT00265317|Secondary|Number of Participants on Anti-hypertensive Medications|Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.|Randomization to Day 28 of Cycle 18|Per Protocol Set; data were not analyzed||||||
1279990|NCT00270790|Secondary|Response Rates Based on the Study Regimen|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 years|21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.|||participants|||Number
1279991|NCT00270790|Primary|Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine|Blood work (CMP was collected and evaluated for neutropenia, leukopenia and anemia) is taken prior to chemotherapy administration. The toxicity levels were measured using Common Terminology Criteria for Adverse Events (CTCAE 3.0) and monitored based on the dose of Amifostine given.|3 years|21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.|||participants|||Number
1279992|NCT00270634|Secondary|A Composite of Biopsy-proven Chronic Rejection Graft Loss, Death, or Lost to Follow up.||Six months|Per Protocol Dataset|||Percentage of patients|||Number
1279993|NCT00270634|Secondary|Hypertension, Hyperlipidemia, or Hyperglycemia||Six months|Endpoint|||Percentage of patients|||Number
1279994|NCT00270634|Secondary|Graft Survival||Six months||||Percentage of patients|||Number
1279995|NCT00270634|Secondary|Patient Survival||Six months||||Percentage of patients|||Number
1279996|NCT00270634|Secondary|The Pharmacokinetic-pharmacodynamic Relationship Between Voclosporin and Calcineurin Inhibition (CNi), or Tacrolimus and Calcineurin Inhibition|"A sparse sampling protocol of whole blood samples obtained on Day 180 at time points immediately prior to drug administration and at 1, 2, and 4 hours post‐dose were utilized.~Standard non‐compartmental analysis (NCA) was performed on whole blood concentration data for voclosporin and its metabolites, tacrolimus, MPA (mycophenolic acid) and MPAG (mycophenolic acid glucuronide). Tmax and Cmax were obtained directly from the concentration‐time profiles without interpolation. AUC(0‐4)[area under the curve] was calculated using log‐linear trapezoidal rule. Cmax, AUC(0‐4), C0 and C2 were summarized using descriptive statistics."|Six months|For subjects participating in the PK/PD portion of the study, a calcineurin sample was drawn prior to drug administration in order to assess baseline calcineurin levels. Blood samples were taken at Month 6 for the assessment of pharmacokinetics and pharmacodynamics. Participation by subjects was optional.|||% Calcineurin (CNi) compared to baseline||Standard Deviation|Mean
1279997|NCT00270634|Secondary|To Demonstrate a 5% Improvement in Renal Function as Measured by Iothalamate Glomerular Filtration Rate (GFR)|ANOVAs to test for differences in GFR at Month 6.|Six months|Standard deviation around Iothalamate GFR made results uninterpretable, therefore Nankivell GFR was reported as it was collected a priori.|||mL/min||Standard Deviation|Mean
1279998|NCT00270634|Primary|Biopsy Proven Acute Rejection (BPAR)|The primary objective of the PROMISE trial was to demonstrate noninferiority of biopsy proven acute rejection (BPAR) rate in de novo renal transplant patients at 6 months in at least one VCS treatment group.|Six months||||percentage of participants|||Number
1279999|NCT00270296|Primary|Number of HIV+ Infants|Number of infants with HIV-positive status|Throughout study, including breastfeeding, assessed up to 24 months|Analysis is based on actual number of available patients, and may not perfectly match the Patient Flow module.|||Infants|||Number
1280000|NCT00270296|Primary|Number of Participants With Virologic Suppression|Suppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter|Throughout study, including breastfeeding, assessed up to 24 months||||Participants|||Count of Participants
1280001|NCT00270257|Secondary|Incident Hepatitis B Infections|Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg.|Measured through week 52||||participants with HBsAg|||Number
1280002|NCT00270257|Secondary|Incident Hepatitis C Infections for Thailand and China|"HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later.~If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint).~Analysis was done separately for both countries"|Measured through week 156 in Thailand and 104 weeks in China|Baseline HCV antibody negative participants.|||participants with HCV antibody|||Number
1280003|NCT00270257|Secondary|Self-reported Number of Injections in the Last Month||Measured through Week 104|Number of participants presented here applies to whom data available at week 104.|||injections||Inter-Quartile Range|Median
1280004|NCT00270257|Secondary|Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months||Measured through Week 104|Number of participants presented here applies to whom data available at week 104.|||participants|||Number
1280005|NCT00270257|Secondary|Self-report of Continued Injection Opiate Use in the Last 30 Days|All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits.|Measured through Week 104|Number of participants presented here applies to whom data available at week 104.|||participants|||Number
1280006|NCT00270257|Secondary|Number of Participants With Urinalysis Results Positive for Opiates|Urine drug screen were assessed monthly and semiannually.|Measured through Week 104|Number of participants presented here applies to visit 104 for whom data available.|||participants|||Number
1280029|NCT00270205|Secondary|Anti-dsDNA Antibody Response|Results report the number of participants who had negative anti-dsDNA antibody result at baseline and at week 17 or 61.|From start of study vaccination to week 61|All participants who started study vaccination and who have anti-ds DNA results at baseline and week 17 or 61 were included in the analysis.|||participants|||Number
1280575|NCT00265239|Primary|Cardiac Death|number of cardiac death|415±32 days||||events|||Number
1280007|NCT00270257|Primary|Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks|The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect.|For visits up to week 104|Data Safety Monitoring Board (DSMB) halted the study on October 4, 2011 due to futility as a result of lower than anticipated HIV incidence rates. See participant flow section for the number of participants who completed visit up to 104 by July 31, 2012.|||participants|||Number
1280008|NCT00270231|Primary|Number of Nicotine Cigarette Choices Taken During the Cigarette Choice Procedure.|"On day 4 of each study medication period, participants completed a cigarette choice procedure where the subject is asked to take 4 puffs from a nicotinized (nicotine-containing) or a denicotinized (no nicotine) cigarette every 30 minutes for 2 hours (maximum of 24 puffs). The outcome variable is the number of nicotine cigarette choices or puffs out of 24 total puffs during these cigarette choice procedures.~Subjects who had the A/A genotype took an average of 18.5 puffs from the nicotine-containing cigarettes. Subjects with the A/G or G/G genotypes took an average of 16.2 puffs from the nicotine-containing cigarettes."|2 hours|Participants were analyzed with respect to genotype regardless of intervention.|||Number of Nicotine Cigarette Puffs Taken||Standard Deviation|Mean
1280009|NCT00270205|Other Pre-specified|Breadth of HIV-1-specific Immune Response, as Determined by the Number of Overlapping HIV-1 Peptides for Which the ELISPOT Assay for IFN-gamma Production is Observed to Have Five or More Spot-forming Cells/ 10^5 PBMCs|Additional outcome measure for possible supportive exploratory analysis. The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.|From start of study vaccination to week 24|There are no data available for the analysis.||||||
1280010|NCT00270205|Secondary|Lymphocyte Proliferation Stimulation Index (SI) in Response to Whole HIV-1 Antigen, p24 Antigen, and Pooled HIV-1 Peptide Antigens|The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.|From start of study vaccination to week 24|There are no data available for the analysis.||||||
1280011|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
1280012|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280013|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
1280014|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280015|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
1280016|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280017|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
1280018|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280019|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.|||percent||Inter-Quartile Range|Median
1280020|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.|||percent||Inter-Quartile Range|Median
1280021|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280022|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280023|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
1280024|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
1280025|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
1280026|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to anti-CD3 antigen were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280027|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to whole HIV-1 antigen were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280028|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm3||Inter-Quartile Range|Median
1280030|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.|||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
1280031|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|At each week, the mean spot-forming cells/10^6 PBMCs across gag p17, gag p24, gag 15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.|||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
1280032|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen as detected by the PHPC assay. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.|||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
1280033|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|At each week, the mean spot-forming cells/10^6 PBMCs detected by the PHPC (precursors with high proliferative capacity) assay across gag p17, gag p24, gag p15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.|||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
1280034|NCT00270205|Secondary|Time-averaged AUC of CD8+ T-cell Count in PBMCs|Area under the curve (AUC) using linear trapezoidal method, of CD8+ T-cell count responses was used to characterize each participant's overall CD8+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.|From start of study vaccination to week 61|Only those participants who started study vaccination and who have complete and non-missing CD8+ T-cell count responses at all study visits were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1280035|NCT00270205|Secondary|Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs|Area under the curve (AUC) using linear trapezoidal method, of CD4+ T-cell count responses was used to characterize each participant's overall CD4+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.|From start of study vaccination to week 61|Only those participants who started study vaccination and who have complete and non-missing CD4+ T-cell count responses at all study visits were included in the analysis.|||cells/mm3||Inter-Quartile Range|Median
1280036|NCT00270205|Primary|Percent of Participants With Primary Safety Endpoint|Primary safety endpoint is defined as occurrence of at least one grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment. Event's relationship to the study treatment was determined by the protocol core team, including site clinicians on the team, blinded to the treatment arm. Adverse events solely attributed to an allergic reaction to the adhesive of the tape used to adhere the vaccination patch to the skin and not the vaccine itself were not used in determination of the primary safety endpoint.|From start of study vaccination to 28 days after the last study vaccination|Only those participants who started study treatment/vaccination were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1280037|NCT00269919|Secondary|Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score|A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline and Week 96|The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of risperidone long acting injection (RLAI). Here, ‘N'=the participants who were evaluated for this outcome measure and ‘n'=the participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1280038|NCT00269919|Secondary|Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of medication and 2) attitudes and beliefs toward neuroleptics which may influence medication compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score for each person at each time is the positive score minus the negative score.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1280039|NCT00269919|Secondary|Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score|"The LUNSERS is a self-report measure of antipsychotic side effects. It consists of 51 questions, 41 questions on side effects and 10 questions are of red herrings to validate the results. Each question is rated on a 4-point scale, where 0=not at all; and 4=very much. The total neuroleptic side effect score is the sum of the scores for the side effects items (i.e. all items excluding the red herrings). Total side effects score ranges from 0 to 164, where 0 to 40=low side effect rating, 41 to 80=medium side effect rating and greater than 81=high side effect rating."|Baseline and Week 96|The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of RLAI. Here, ‘N'=the participants who were evaluated for this outcome measure and ‘n'=the participants who were evaluated for this outcome measure at given time point.|||Unit on a scale||Standard Deviation|Mean
1280040|NCT00269919|Secondary|Change From Baseline in NCFT: TMT-Error at Week 96|TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the the number of errors.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."|||Errors||Standard Deviation|Mean
1280041|NCT00269919|Secondary|Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96|TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the response time.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."|||Seconds||Standard Deviation|Mean
1280042|NCT00269919|Secondary|Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96|MQ was obtained by adding up the results of verbal memory and visual memory test. The memory quotient will include learning curve, memory retention, retrieval efficiency, drawing/memory consistency, verbal/visual memory consistency and intelligence/memory consistency. The highest MQ is 160, which indicates excellent memory.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."|||MQ||Standard Deviation|Mean
1280043|NCT00269919|Secondary|Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96|The RCFT is a neuropsychological assessment designed to evaluate visual memory in participants. The RCFT is useful in evaluating the spatial perception and visual memory. The RCFT consists of 3 test conditions: Copy, Immediate Recall and Delayed Recall. At the first step, participants are given the RCFT stimulus card, and then asked to draw the same figure. Subsequently, they are instructed to draw what they remembered. Then, after a delay of 30 min, they are required to draw the same figure once again, a score of 2 points for each drawn element (a complete straight line or a circle) remembered correctly. The total score is the sum of points scored for each correctly drawn element and it ranges from 0 to 36. The maximum score indicates excellent visual memory.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1280044|NCT00269919|Secondary|Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96|The KAVLT is a neuropsychological assessment designed to evaluate verbal memory in participants. The KAVLT is useful in evaluating the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the participants hears a list of 15 words, and are asked to recall as many words from the list as possible. This procedure is carried out a total of 5 times. Then a second list of 15 words is presented, allowing the participants only 1 attempt to recall. Immediately following this, the participants are asked to remember as many words as possible from the first list. KAVLT consists of 2 test conditions: Delayed Recall and Delayed Recognition. The upper limit for ‘words recalled’ is 15, which represents better episodic memory.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.Here ‘N'=participants who were evaluated for this outcome measure and ‘n'=participants who were evaluated for this outcome measure at given time point.|||Words recalled||Standard Deviation|Mean
1280045|NCT00269919|Secondary|Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96|The Controlled Oral Word Associated Test is a measure of verbal fluency, which requires participants to generate words orally that begin with a given letter of the alphabet. Participants are given 1 min to name as many words as possible. Performance was calculated by the number of words generated in the 1-min period. This measure, requiring rapid and organized word retrieval, is a sensitive indicator of brain dysfunction.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here ‘N'=participants who were evaluated for this outcome measure.|||Words generated per min||Standard Deviation|Mean
1280055|NCT00269152|Secondary|3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.|length of time disease free, assessed at 3 years|All randomized participants. Intent to Treat population.|||probability of disease-free survival (%)||95% Confidence Interval|Number
1281111|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
1280046|NCT00269919|Secondary|Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96|The K-WAIS is a Korean version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R). It is an intelligence test that assess 3 general areas of intelligence quotients (IQ): verbal IQ, performance IQ and full-scale IQ (FSIQ). The verbal IQ includes: Digit Span, Vocabulary, and Arithmetic; performance IQ includes: Picture Arrangement and Block Design; and FSIQ is an IQ assessed by measuring an individual's overall level of general cognitive and intellectual functioning. The highest FSIQ is 160. The greater the quotient, higher the level of intelligence.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here ‘N'=participants who were evaluated for this outcome measure and ‘n'=participants who were evaluated for this outcome measure at given time point.|||Intelligence quotient (IQ)||Standard Deviation|Mean
1280047|NCT00269919|Secondary|Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96|The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1280048|NCT00269919|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96|GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. Lower scores indicate worsening.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1280049|NCT00269919|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96|The CGI-S rating scale is used to rate the severity of a participant's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1280050|NCT00269919|Primary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96|The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.|Baseline and Week 96|The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 efficacy measurement post-baseline. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1280051|NCT00269633|Primary|Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks|Outcome for Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD) reported is the average over 3 weeks. Lower values represent less depressive symptoms. Range is 0-53.|Averaged over Three Weeks During Treatment||||units on a scale||Standard Deviation|Mean
1280052|NCT00269477|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions|Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population|||Participants|||Number
1280053|NCT00269477|Primary|Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.|"Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination.~Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination."|28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)|SBA-BR titer for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Participants|||Number
1280054|NCT00269152|Secondary|Overall Survival at 6 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.|Baseline to date of death from any cause assessed at 6 years|All randomized participants. Intent to treat population.|||percent probability of survival (%)||95% Confidence Interval|Number
1280093|NCT00268983|Secondary|Hematologic Nadir for Platelet Count and White Blood Cell (WBC) Count|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||10^3/microliter (µL)||Full Range|Median
1280056|NCT00269152|Secondary|Overall Survival at 3 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.|baseline to date of death from any cause, assessed at 3 years|All randomized participants. Intent to treat population.|||percent probability of survival (%)||95% Confidence Interval|Number
1280057|NCT00269152|Secondary|Grade III/IV Adverse Events|Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.|every 21-day cycle for 4 cycles|Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).|||participants|||Number
1280058|NCT00269152|Primary|The Feasibility of Post-Surgery Chemotherapy|Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.|every 21-day cycle for 4 cycles up to 30 days after last infusion|Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).|||participants|||Number
1280059|NCT00269113|Secondary|Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months|Time to next treatment was defined as the interval from randomization date to the time when new treatment was needed. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
1280060|NCT00269113|Secondary|Response Duration - Percentage of Participants Event Free at 24 Months|Response duration defined as interval from first assessment of CR/PR to PD. PD is an increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
1280061|NCT00269113|Secondary|Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months|DFS was defined as the interval from first assessment of CR to PD. PD is an increase in the frequency and severity of disease symptoms, the occurrence of new nodal or extranodal lymphoma manifestations, the volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
1280062|NCT00269113|Secondary|Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months|EFS was defined as the interval from randomization date to therapy failure. Therapy failure was defined after 2 cycles as no change (NC) or progression of disease (PD); after 6 cycles as minimal response [MR], NC, or PD); or death from any cause. NC is defined as tumor regression of <25%, stable disease and progression ≤25%. PD was defined as the increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, and increase of splenomegaly by more than 25%. MR was defined as tumor regression between 50% (<50%) and 25% (≥25%) for at least 4 weeks without occurrence of new manifestations. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
1280063|NCT00269113|Secondary|Overall Survival (OS) - Percentage of Participants Alive at 24 Months|OS was defined as interval from randomization to date of death of any cause. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
1280064|NCT00269113|Secondary|Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months|PFS was defined as the interval from randomization date to progression of disease or death from non-Hodgkin's Lymphoma (NHL). Progression of disease was defined as: increase in the frequency and severity of disease symptoms; occurrence of new nodal or extranodal lymphoma manifestations; volume increase of pre-existing lymphoma manifestations by more than 25%; or increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha equals (=) 5% for difference between the treatment groups.|24 months|ITTcbcc/FL Population|||percentage of participants|||Number
1280065|NCT00269113|Primary|Percentage of Participants Achieving CR or PR at the End of Therapy|CR was defined as a complete remission of all objective medical findings at the time of restaging, with complete resolution of pre-existing swelling of the lymph nodes, as well as a pre-existing hepatomegaly and splenomegaly, for at least 4 weeks. This was in exclusion of persistent lymphoma infiltration of the bone marrow by means of bone marrow biopsy; normalization of blood counts with granulocytes greater than (>)1.5 giga particles per liter (Gpt/L) (which is the equivalent of 10^9/L), hemoglobin (Hb) >7.5 millimoles per liter (mmol/L), and platelets less than (<) 100 Gpt/L. PR was defined as greater than or equal to (≥)50 percent (%) reduction of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest perpendicular diameters) for at least 4 weeks without occurrence of new manifestations and normalization of blood counts.|Following completion of 6 cycles (24 weeks)|The ITT centroblastic-centrocytic (cbcc)/Follicular Lymphoma (FL) (collectively, ITTcbcc/FL) population included all participants in the ITT population with cbcc lymphoma (target population).|||percentage of participants||95% Confidence Interval|Number
1280066|NCT00268996|Secondary|Change From Baseline in Fibrous Tissue and Fibro-fatty as a Percent of IVUS-VH Plaque as IVUS-VH Assessments at Week 52|Fibro-fatty as percentage of VH plaque and Fibrous tissue as percentage of VH plaque were derived from IVUS-VH system. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline was calculated as Fibro-fatty as percentage of VH plaque or Fibrous tissue as percentage of VH plaque at Week 52 minus baseline value. The data was reported based on observed cases. Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Baseline and Week 52|Imaging evaluable population|||Percentage of VH||Standard Error|Least Squares Mean
1280067|NCT00268996|Secondary|Change From Baseline in Fibrous Tissue Volume and Fibro-fatty Volume as IVUS-VH Assessments at Week 52|"Change from baseline in fibrous tissue volume and fibro-fatty volume were derived from IVUS system at each IVUS grey scale assessment recorded. Fibrous tissue volume was calculated as mean fibro-fatty area multiplied by mean of Baseline and Follow-up length. Fibro-fatty volume was calculated as mean fibrous area multiplied by mean of Baseline and Follow-up length.~The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline was calculated as mean Fibrous tissue volume or Fibro-fatty volume at Week 52 minus baseline value. The data was reported based on observed cases. Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates."|Baseline and Week 52|Imaging evaluable population|||mm^3||Standard Error|Least Squares Mean
1280068|NCT00268996|Secondary|Change From Baseline in Mean Plaque Area, Mean Vessel Area, and Mean Lumen Area as IVUS-Grey Scale Assessments at Week 52.|Change from baseline in was mean plaque area, mean vessel area, and mean lumen area were derived from IVUS system at each IVUS grey scale assessment recorded. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline was calculated as mean area of the parameter (plaque/vessel/lumen) at Week 52 minus baseline value. The data was reported based on observed cases. Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Baseline and Week 52|Imaging evaluable population|||mm2||Standard Error|Least Squares Mean
1280069|NCT00268996|Secondary|Change From Baseline in Vessel Volume and Lumen Volume as IVUS-Grey Scale Assessments at Week 52.|Change from baseline in vessel volume and lumen volume calculated for each IVUS grey scale assessment recorded. Vessel volume (i.e., coronary remodelling) defined by the leading edge of echogenic adventitia/external elastic membrane (EEM) and calculated as, mean vessel area multiplied mean of vessel length at Baseline and Follow-up. Lumen volume was circumscribed by the leading edge of intima/plaque and calculated as mean lumen area multiplied by mean lumen length at Baseline and Follow-up. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline was calculated as vessel volume or lumen volume at Week 52 minus baseline value.|Baseline and Week 52|Imaging evaluable population|||mm^3||Standard Error|Least Squares Mean
1280070|NCT00268996|Secondary|Mean Levels of Oxidized Non-esterified Fatty Acids (Ox-NEFA) as Target Circulating Biomarkers at the End of Week 26 and Week 52|Mean ox-NEFA levels as circulating biomarkers associated with Lp-PLA2 target-related biomarkers at Week 26 and Week 52 was planned to be assessed. However, the parameter data were not collected for this endpoint.|Week 26 and Week 52|Biomarker evaluable population||||||
1280071|NCT00268996|Secondary|Mean Levels of Oxidised Phospholipids/ Apolipoprotein B100 (oxPL/apoB) Ratio as Target Circulating Biomarkers at the End of Week 26 and Week 52.|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean OXPL/LAPO B levels as circulating biomarkers associated with Lp-PLA2 target-related biomarkers at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. OXPL/LAPO B had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of OXPL/LAPO B levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population.|||Relative light units (RLU)||95% Confidence Interval|Geometric Mean
1280072|NCT00268996|Secondary|Mean Matrix Metaloproteinases-9 (MMP-9) Levels as Circulating Biomarkers Associated With Plaque Instability at Week 26 and Week 52.|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean MMP-9 levels as circulating biomarkers associated with plaque instability at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward MMP-9 had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of MMP-9 levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population|||microgram per litre (mcg/L)||95% Confidence Interval|Geometric Mean
1280073|NCT00268996|Secondary|Mean sCD40L Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean sCD40L levels as circulating biomarker associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. sCD40L had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of sCD40L levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Safety Population comprised of all randomized participants who received at least one dose of study drug. Only those participants with data available at the indicated time points were analyzed.|||pg/ml||95% Confidence Interval|Least Squares Mean
1280074|NCT00268996|Secondary|Mean Myeloperoxidase (MPO) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean MPO levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. MPO had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of MPO levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population|||picomole per litre (pmol/L)||95% Confidence Interval|Geometric Mean
1280094|NCT00268983|Secondary|Hematologic Nadir for Hemoglobin|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||Grams per deciliter (G/dL)||Full Range|Median
1280095|NCT00268983|Secondary|Hematologic Nadir for Absolute Neutrophil Count|Hematologic toxicity includes the analysis of hematologic nadir, which is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population excluding participants that did not have data within the 120 days of study drug administration.|||10^3/cubic millimeter (mm^3)||Full Range|Median
1280075|NCT00268996|Secondary|Mean Intercellular Adhesion Molecule-1 (ICAM-1) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean ICAM-1 levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. ICAM-1 had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of ICAM-1 levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population.|||nanogram per millilitre (ng/mL)||95% Confidence Interval|Geometric Mean
1280076|NCT00268996|Secondary|Mean Interlukin 6 (IL-6) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean IL-6 levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. IL-6 had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of IL-6 levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population|||Nanograms per litre (ng/L)||95% Confidence Interval|Geometric Mean
1280077|NCT00268996|Secondary|Change From Baseline in Necrotic Core as a Percent of IVUS-VH Plaque at the End of Week 52.|Change from baseline was calculated for each IVUS-VH assessment recorded at the end of study. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline in percent necrotic core was calculated as percent necrotic core at Week 52 minus baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates. Change from Baseline in necrotic core as a percent of IVUS-VH plaque at the end of week 52 was reported.|Baseline and Week 52|Imaging evaluable population|||Percent Necrotic core||Standard Error|Least Squares Mean
1280078|NCT00268996|Secondary|Change From Baseline in Necrotic Core Volume as Intravenous Ultrasound-Virtual Histology (IVUS-VH) Assessments at Week 52|Change from Baseline was calculated for each IVUS-VH assessment recorded at the end of study. The necrotic core volume was calculated as mean necrotic area multiplied by mean of Baseline and follow-up length. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, Baseline value, matched segment length and treatment included as covariates. The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline in necrotic core volume as IVUS-VH assessments at Week 52 was reported.|Baseline and Week 52|Imaging evaluable population. Only those participants with data available at the indicated time points were analyzed.|||mm^3||Standard Error|Least Squares Mean
1280079|NCT00268996|Secondary|Change From Baseline in Percent Obstruction Volume as IVUS-Grey Scale Assessments at Week 52|Change from Baseline in percent obstruction volume was calculated for each IVUS grey scale assessment recorded. Percent obstruction volume was calculated as (Plaque volume/ Vessel volume *100). The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Baseline and Week 52|Imaging evaluable population|||Percentage of mm^3||Standard Error|Least Squares Mean
1280080|NCT00268996|Secondary|Change From Baseline in Plaque Volume as IVUS-Grey Scale Assessments at Week 52|Change from Baseline was calculated for each IVUS grey scale assessment recorded at the end of study. The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, Baseline value, matched segment length and treatment included as covariates.|Baseline and Week 52|Imaging evaluable population|||Cubic millimetre (mm^3)||Standard Error|Least Squares Mean
1280081|NCT00268996|Secondary|Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52|Lp-PLA2 is a calcium-independent phospholipase A2 enzyme associated with low density lipoprotein (LDL) in plasma. Blood samples were collected at baseline and at Week 4, 13, 26, and 52 and Lp-PLA2 activity was determined. Percentage inhibition of Lp-PLA2 activity relative to baseline was calculated as, percent inhibition = ([baseline value - post baseline value] x 100) / baseline value. The baseline value for each participant was defined as the last value prior to the first dose of study drug.|Week 26 and Week 52|The biomarker evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable biomarker assessment at 3 months (Day 77) or later.|||micromole per minute per Litre||95% Confidence Interval|Geometric Mean
1280082|NCT00268996|Secondary|Circulating Hs-CRP at the End of Week 26.|hs-CRP is a pentameric protein that is rapidly upregulated in response to inflammation and tissue damage and assessed as circulating biomarkers associated with atherosclerosis and cardiovascular risk. LOCF data was reported. Only data from 3 months onwards was carried forward. hs-CRP has a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of hs-CRP levels at Week 26 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26|Biomarker evaluable population|||mg/L||95% Confidence Interval|Geometric Mean
1280096|NCT00268983|Secondary|Time to Next Treatment|Time to next treatment is defined as time from the date of randomization until the new treatment is needed for NHL. Because too few evaluable participants were enrolled/treated, analysis of the time to next treatment was not conducted as planned.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||||||
1280097|NCT00268983|Secondary|Number of Participants Who Had Died by the Month Indicated|The median time to death could not be calculated for participants in either treatment group; thus, data are shown as the number of participants who had died by the month indicated.|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||participants|||Number
1280083|NCT00268996|Primary|Change From Baseline in the Density of Rotterdam Classification (ROC) Grade III/IV Strain Spots/10 Millimeter (mm) Within the Region of Interest (ROI) on IVUS Grey Scale Based Palpography at the End of Week 52.|The ROC grade III/IV strain spots per 10 millimetre (mm) within the ROI on intravascular ultrasound (IVUS) grey scale based palpography were assessed and change from Baseline at end of 52 was reported. Change from Baseline was calculated as the density of spots at the end of study minus the density of spots recorded at Baseline. If either value was considered missing then the change from Baseline value was missing for the participant. Between treatment group comparisons of change from Baseline were analyzed using ANCOVA adjusting for ACS status, pooled country, Baseline value, matched segment length and treatment. Adjusted means and associated standard errors for each treatment group were presented. The baseline value for each participant was defined as the last value prior to the first dose of study drug.|Baseline and Week 52|The imaging evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable baseline and end of treatment imaging assessment at 6 months (Day 154) or later. The participants available at the time of assessment were included in the analysis.|||Spots/10 mm||Standard Error|Least Squares Mean
1280084|NCT00268996|Primary|Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52.|hs-CRP is a pentameric protein that is rapidly upregulated in response to inflammation and tissue damage and assessed as circulating biomarkers associated with atherosclerosis and cardiovascular risk. Last Observation Carried Forward (LOCF) data was reported. Only data from 3 months onwards was carried forward. hs-CRP has a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of hs-CRP levels at Week 52 were reported. The levels were analyzed using analysis of co-variance (ANCOVA), with Acute Coronary Syndrome (ACS) status, pooled country and treatment included as covariates.|Week 52|The biomarker evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable biomarker assessment at 3 months (Day 77) or later.|||mg per litre (mg/L)||95% Confidence Interval|Geometric Mean
1280085|NCT00268983|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a Grade 4 (life threatening or disabling) non-hematologic laboratory abnormality assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|From randomization through Week 26|ITT-Exposed Population|||Participants|||Number
1280086|NCT00268983|Secondary|Number of Participants With Myelodysplasia/Leukemia|The cumulative incidence of myelodysplasia/leukemia was estimated.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||Participants|||Number
1280087|NCT00268983|Secondary|Number of Hospitalizations|The frequency of hospitalizations within 90 days of treatment was summarized. Because too few evaluable participants were enrolled/treated, analysis of the number of hospitalizations was not conducted as planned.|Time of treatment until 90 days post-treatment|ITT-Exposed Population||||||
1280088|NCT00268983|Secondary|Number of Participants With an Infusion Reaction|An infusion reaction is defined as any adverse event that occured within 24 hours of an infusion. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|First 24 hours of study drug administration.|ITT-Exposed Population|||participants|||Number
1280089|NCT00268983|Secondary|Number of Participants That Developed Hypothyroidism|Hypothyroidism is defined as elevated Thyroid-Stimulating Hormone (TSH) or current history of using thyroid medication. The frequency of hypothyroidism at study enrollment will be determined, and participants with hypothyroidism at Baseline were excluded from analysis.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||Participants|||Number
1280090|NCT00268983|Secondary|Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters|Duration of Grade 3/4 toxicity is defined as the time between the date of the first Grade 3/4 lab result to the first lab date with a Grade of 0, 1, or 2 result. Laboratory abnormalities will be recorded as AEs using NCI CTCAE, Version 3, if they are associated with clinical squeal and/or require an intervention. Specific AEs not listed in the NCI criteria will be graded as follows: 1. Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities, 2. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities, 3. Severe: An event that prevents normal everyday activities, 4. Life-threatening or debilitating, and 5. Death|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population. Participants with a Grade 3/4 toxicity level for the indicated hematological parameters were analyzed (reflected by n=X, X). Different participants may have been analyzed for different parameters; thus, the overall number analyzed reflects everyone in the ITT-Exposed Population.|||Days||Full Range|Median
1280091|NCT00268983|Secondary|Time to Recovery to Baseline Grade for the Indicated Hematological Parameters|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to recovery to Baseline grade is defined as the number of days from the last administration of study drug to a post-nadir hematology value of unmaintained Baseline grade or lower.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||Days||95% Confidence Interval|Median
1280092|NCT00268983|Secondary|Time to Nadir Values for the Indicated Hematological Parameters|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to nadir is defined as the number of days from the last administration of study drug to nadir.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||Days||Standard Deviation|Mean
1280098|NCT00268983|Secondary|Time to Death|"Time to death is defined as the time from treatment start to the date of death. As a median time to death is not presented for either group, see the outcome measure entitled Number of Participants Who Had Died by the Month Indicated for data regarding time to death."|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||months||95% Confidence Interval|Median
1280099|NCT00268983|Secondary|Duration of Response|Response duration is defined as the time from the first documented response (complete response, complete response unconfirmed, or partial response) until disease progression. Partial response is defined as at least a 50% decrease in the product of two perpendicular diameters of all measurable lesions; no increase in the size of other nodes, liver, or spleen; and no new disease sites.|Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually|ITT-Exposed Population. Only those participants with confirmed or unconfirmed complete response or partial response were analyzed for duration of response.|||months||95% Confidence Interval|Median
1280100|NCT00268983|Secondary|Number of Participants Achieving Response|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms (by the IWSRC) if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Confirmation of response was carried out by an independent reviewer|Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually|ITT-Exposed Population|||Participants|||Number
1280101|NCT00268983|Primary|Progression-free Survival|Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||months||95% Confidence Interval|Median
1280102|NCT00268983|Primary|Event-free Survival (EFS)|Event-free survival is defined as the time from the date of randomization to the first occurrence of (whichever came first) progressive disease, death, or additional Non-Hodgkins Lymphoma (NHL) therapy due to disease-related symptoms, threatened end-organ function, cytopenias secondary to NHL, massive bulk disease, or steady progression over at least 6 months. Progressive disease is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|Intent-to-Treat (ITT)-Exposed Population: all participants who received at least one dose of treatment|||Months||95% Confidence Interval|Median
1280103|NCT00268905|Secondary|Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD).|From start of eribulin treatment until disease progression or death|Efficacy Evaluable Population|||percentage of subjects|||Number
1280104|NCT00268905|Secondary|Safety of Eribulin Mesylate in Combination With Carboplatin as Measured by the Number of Subjects With Treatment Emergent Adverse Events.|Adverse events were considered treatment emergent if they started on or after the date of administration of the first dose of study drug, or if they were present prior to the administration of the first dose of study drug and increased in severity during the study.|Throughout the entire study|Safety Evaluable Population|||participants|||Number
1280105|NCT00268905|Primary|Maximum Tolerated Dose (MTD) of Eribulin Mesylate of E7389 in Combination With Carboplatin in Subjects With Advanced Solid Tumors.|MTD was established by summarizing the number and percent of subject with dose- limiting toxicities (DLTs) for the first cycle.|21 days (first cycle)||||mg/m^2|||Number
1280106|NCT00268892|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|4.5 years||||participants|||Number
1280107|NCT00268892|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.|Baseline and up to 4.5 years|The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A.|||participants|||Number
1280108|NCT00268762|Secondary|Arterial Complete Recanalization at 24 Hours Post tPA Bolus|Complete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.|24 hours from tPA bolus||||percent of patients|||Number
1280109|NCT00268762|Secondary|Arterial Complete Recanalization at 2 Hours Post tPA Bolus|Complete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.|2 hours complete recanalization post tPA bolus||||percent of patients|||Number
1280110|NCT00268762|Primary|Symptomatic and Radiographic Intracerebral Hemorrhage|"Significant intracerebral hemorrhage as defined by either:~Symptomatic intracerebral hemorrhage or~Parenchymal hematoma type 2."|Within 7 days of enrollment||||percentage of patients||95% Confidence Interval|Number
1280768|NCT00262951|Secondary|Overall Survival|In all patients, measured from the date of the patient’s registration in this study, until the date of the patient’s death or date last known alive (if observation was censored).|Up to 5 Years or Date of Death, Whichever Occurred First||||Months||95% Confidence Interval|Median
1280111|NCT00268463|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy Trial Outcome Index at Baseline, at 4-6 Weeks Following Surgery (Before Initiation of Chemotherapy), and Periodically During Study||Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy|||||||
1280112|NCT00268463|Secondary|Scales Specific to Social/Family, Emotional, and Functional Well-being, Perceived Convenience of Care, and Self-reported Symptoms||Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy|||||||
1280113|NCT00268463|Secondary|Survival as Measured by Time to Death From Any Cause.||Time from randomization through year 5|||||||
1280114|NCT00268463|Secondary|Liver PFI as Measured by Time to Hepatic Progression.||Time from randomization through year 5|||||||
1280115|NCT00268463|Primary|Progression-free Interval (PFI)|Time to first recurrence of colon cancer at any site|Time from randomization through year 5|||||||
1280116|NCT00268450|Secondary|Rate of Post-operative Complications||from first treatment until up to 48 hours after surgery.|Data for this outcome measure was not collected||||||
1280117|NCT00268450|Secondary|Percentage of Planned Dose Received||from first treatment until end of week 12|Data for this outcome measure was not collected||||||
1280118|NCT00268450|Secondary|Median Overall Surivial||from first treatment until death|Data for this outcome measure was not collected||||||
1280119|NCT00268450|Secondary|Progression Free Survival||from first treatment until time of progression or death, whichever comes first|Data for this outcome measure was not collected||||||
1280120|NCT00268450|Secondary|Urinary Cytogenitics||baseline and week 12|Data for this outcome measure was not collected||||||
1280121|NCT00268450|Secondary|Urinary Survivin Levels||Baseline, week 6 and week 12|Data for this outcome measure was not collected||||||
1280122|NCT00268450|Primary|Complete Remission Rate||From day of first treatment until after cycle 3|Data for this outcome measure was not collected||||||
1280123|NCT00268437|Secondary|Overall Survival|Time from registration to death due to any cause.|From baseline to 4 years||||months||95% Confidence Interval|Median
1280124|NCT00268437|Primary|Pathologic Complete Response Rate|The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.|Baseline to time of surgery (around 10 – 18 weeks post-baseline)||||percentage of participants||95% Confidence Interval|Number
1280125|NCT00268346|Primary|The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.|The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.|at 8 weeks after initiation of treatment|All patients enrolled were analyzed|||participants|||Number
1280126|NCT00268242|Secondary|Percentage of Patients Making it to Bone Marrow Transplant.|Assessing the number of patients who were able to have protocol treatment and have a bone marrow transplant after treatment.|After completion of protocol therapy||||percentage of Patients completed a BMT|||Number
1280127|NCT00268242|Primary|Duration of the First Complete Response||After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.|Only 5 patients had a complete response, therefore on 5 patients were analyzed for this measure.|||months||Full Range|Median
1280128|NCT00268242|Secondary|White Blood Cell Count at Time of Relapse||After a CR is achieved, patient will be followed at 3 month intervals for disease progression, typically for up to 5 years.||||cells per microliter||Full Range|Median
1280129|NCT00268242|Secondary|Laboratory Correlates: Immunohistochemistry|"Percentage of patients who had a moderate-strong (2-3+) expression of multidrug resistance (MDR) genes by immunohistochemistry.~Multidrug resistance gene 1 (MDR1)~Equilibrative nucleoside transporter 2(SLC29A2)"|Baseline|23 of 24 patients had available blocks for Immunohistochemical (IHC) analysis; Participants with the SLC29A2 Gene Expression (n=22)|||percentage of participants|||Number
1280130|NCT00268242|Secondary|Disease-free and Overall Survival||After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.|1 patient died on day 1 of protocol therapy (secondary to complications from AML).|||participants|||Number
1280131|NCT00268242|Primary|Complete Response Rate|Assumptions/ hypothesis: A Complete Response (CR) rate of 30% or less is unacceptable, and 50% or more is promising. A two-stage design will be used. Initially, 18 patients will be enrolled. If 5 or fewer achieve CR, the study will be stopped. Otherwise, an additional 22 patients will be accrued. Accrual was not halted while follow-up of the first 18 evaluable patients was under way. Therefore, 24 patients were enrolled. Four weeks is anticipated for observation for response. Only 5 patients (21%) achieved a CR and therefore, the study was terminated. Since response was assessed using the International Working Group criteria, a complete response was determined by Morphologic complete remission: A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL, a cytogenic CR and a morphologic CR with incomplete blood count recovery (CRi).|4 Weeks|A total of 5 patients (21%) achieved a complete response.|||participants|||Number
1280132|NCT00268203|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal.|From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)|ITT Population. Participants who did not experience treatment failure were censored at the date of their last contact.|||Months||95% Confidence Interval|Median
1280133|NCT00268203|Primary|Time to Progression or Death|Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD.|From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)|ITT Population. Participants who did not have disease progression or death were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
1280134|NCT00268203|Primary|Duration of Response (DOR) in Confirmed Complete Responders|DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From the time of the first documented CR until PD (up to 161 months)|ITT Population. Only those participants with a confirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
1280135|NCT00268203|Primary|Duration of Response (DOR) in Unconfirmed Complete Responders|DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From the time of the first documented unconfirmed CR until PD (up to 161 months)|ITT Population. Only those participants with an unconfirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
1280136|NCT00268203|Primary|Duration of Response for Participants With Confirmed Response (CR+PR)|Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From the time of the first documented response (CR or PR) until disease progression (up to 161 months)|ITT Population. Only those participants with a confirmed CR or PR were analyzed for duration of confirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
1280137|NCT00268203|Primary|Duration of Response for Participants With Unconfirmed Response (CR+PR)|Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From the time of the first documented response (CR or PR) until disease progression (up to 161 months)|ITT Population. Only those participants with an unconfirmed CR or PR were analyzed for duration of unconfirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
1280138|NCT00268203|Primary|Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From randomization until the first documented complete response or partial response (up to 161 months)|Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for confirmed response (those with at least one response assessment) were analyzed.|||Participants|||Number
1280171|NCT00267488|Secondary|Time to Progression|Kaplan-Meier Estimate. Time to progression is defined as time from start of treatment until the first documented sign of disease progression or death due to progressive disease. Subjects who have not progressed or died at the time of analysis will be censored at the time of initiation of alternative anti-cancer therapy or time of last contact. Percentiles represent a set of points on a scale arrived at by dividing a group into parts in order of magnitude.|Week 0 to Week 19 when endpoints were met|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.|||Weeks||95% Confidence Interval|Mean
1280139|NCT00268203|Primary|Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From randomization until the first documented complete response or partial response (up to 161 months)|Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for unconfirmed response (those with at least one response assessment) were analyzed.|||Participants|||Number
1280140|NCT00267969|Secondary|Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52|The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 52 in participants randomly assigned to a treatment group at Week 40. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 52|Patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||participants|||Number
1280141|NCT00267969|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12|Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at Week 12. This DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Baseline (Week 0), Week 12|Patients were included in the analysis according to the assigned treatment groups. Zero change is imputed if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Scores on a scale||Inter-Quartile Range|Median
1280142|NCT00267969|Secondary|Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12|The PGA is used to determine the participant’s psoriasis lesions overall at a given time point. Overall lesions will be graded as : (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|Intent to treat. All patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.|||participants|||Number
1280143|NCT00267969|Primary|Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.|The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 12|Intent to treat. All patients randomized were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.|||Participants|||Number
1280144|NCT00267956|Secondary|Change in Dermatology Life Quality Index (DLQI) at Week 12|Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10 item questionnaire, is designed to assess the impact of the disease on a participant’s quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The score ranges from 0 (better quality of life) to 30 (worse quality of life).|Week 0 to Week 12|All participants randomized with baseline ≥ 3% body surface area psoriatic involvement were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Scores on scale||Inter-Quartile Range|Median
1280145|NCT00267956|Secondary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12|Number of participants achieving greater than or equal to 75 perccentage mprovement PASI at Week 12. PASI is widely used tool for the measurement of severity of psoriasis. This is a test of how bad person's psoriasis is. The combine redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 12|All participants randomized with baseline ≥ 3% body surface area (BSA) psoriatic involvement and with evaluable measurement are included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.|||Participants|||Number
1280146|NCT00267956|Secondary|Change in Health Assessment Questionnaire (HAQ) at Week 12|The HAQ is a 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.|Week 0 to Week 12|Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Scores on scale||Inter-Quartile Range|Median
1280192|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 24 Months||||ratio||Standard Deviation|Mean
1280147|NCT00267956|Secondary|Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12|ACR 70 response is an improvement of greater than or equal to 70 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 12|Intent to treat. All participant randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.|||Participants|||Number
1280148|NCT00267956|Secondary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12|ACR 50 response is an improvement of greater than or equal to 50 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.|||Participants|||Number
1280149|NCT00267956|Primary|Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12|ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 0 to Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.|||Participants|||Number
1280150|NCT00267774|Secondary|Cost Effectiveness Measured as Index Procedural and Hospitalization Costs|Costs for each strategy included the initial procedural costs and costs during the 1-year follow-up. The costs of the index procedures were calculated from the actual resource consumption by determining the amount of guiding catheters, regular wires, pressure wires, balloon dilatation catheters, stents, antiplatelet therapy, adenosine, contrast media, and hospital days used for each patient’s index procedure. These were multiplied by the cost of each resource in US dollars. All costs were converted to 2008 US dollars using the consumer price index (www.bls.gov).|1 year||||US dollars||Standard Deviation|Mean
1280151|NCT00267774|Primary|Major Adverse Cardiac Events|All cause death, Documented myocardial infarction, Repeat revascularization (PCI and/or CABG) as adjudicated by the Clinical Event Committee|1 year||||participants|||Number
1280152|NCT00267748|Other Pre-specified|FACT–Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)|"FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy –Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer.~The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS."|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.|||Units on scale||Standard Deviation|Mean
1280153|NCT00267748|Other Pre-specified|Functional Assessment of Cancer Therapy-General (FACT-G)|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.|||Units on a scale||Standard Deviation|Mean
1280154|NCT00267748|Secondary|Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model|MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date –start of treatment date + 1)/30.44.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.|||Months||95% Confidence Interval|Median
1280193|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 18 Months||||ratio||Standard Deviation|Mean
1280155|NCT00267748|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|DR was calculated for the subgroup of participants from the ITT set, with a confirmed OR.|||Months||Full Range|Median
1280156|NCT00267748|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.|||Percentage of participants||95% Confidence Interval|Number
1280157|NCT00267748|Primary|Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model|MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication.|||Months||95% Confidence Interval|Median
1280158|NCT00267696|Secondary|Overall Survival for Patients Treated With the Regimen.|The period of time from study entry until disease progression or date of last contact.|To progression of Disease||||months||95% Confidence Interval|Median
1280159|NCT00267696|Primary|Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.|Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.|up to 6 months||||months||95% Confidence Interval|Median
1280160|NCT00267670|Secondary|Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months||one year||||ug/mL||Standard Error|Mean
1280161|NCT00267670|Secondary|Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months|Values represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.|baseline and one year||||ng/mL||Standard Error|Mean
1280162|NCT00267670|Secondary|The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH|The mean change from baseline to month 12 in proinflammatory cytokines (such as TNF-α) and gene expresssion were the secondary endpoints and were analyzed with the same analysis of covariance model and summary statistics specified for the primary endpoint. Differences were regarded as statistically significant when P < 0.05. The results for TNF-α are reported here. Interleukin-6 [IL-6], IL-10) and expression of TNF-alpha Receptors (p55 and p75) had insufficient data for statistical analysis.|one year|Intention to Treat with last observation carried forward|||pg/dL||Standard Error|Mean
1280163|NCT00267670|Primary|The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months.|The primary goal of the study was to determine whether pentoxifylline (PTX) therapy improved serum ALT (> or = 30% change from baseline to month 12) compared to placebo.|baseline and 12 months|The primary analysis was done as intention to treat. A secondary analysis was performed per protocol and there were no differences between the two analyses. Intention to treat results are reported.|||participants|||Number
1280164|NCT00267644|Secondary|Minimum IVC Diameter|Minimum Inferior Vena Cava Diameter in mm|10 minutes||||mm||Full Range|Median
1280165|NCT00267644|Primary|Maximum IVC Diameter|Maximum Inferior Vena Cava diameter in mm|10 minutes||||mm||Full Range|Median
1280166|NCT00267631|Primary|Diagnosis of Infectious Disease|The Children visiting the ED having an infectious disease|30 minutes||||Participants|||Number
1280167|NCT00267488|Secondary|Safety and Tolerability as Summarized Through Adverse Event Reporting|AE = Adverse Event reported at a frequency of greater than or equal to 16%. SAE = Serious Adverse Events where all were reported at 0% frequency.|Week 0 to week 98|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.|||Number of Events|||Number
1280168|NCT00267488|Secondary|Time to Response|The time from start of treatment until the first documented response. Not calculated due to no Complete response and only 1 partial response.|Week 0 to week 98||||Hours||95% Confidence Interval|Mean
1280169|NCT00267488|Secondary|Response Duration|The time from initial documented response to the first documented sign of progression or death due to progressive disease. Not calculated due to no Complete response and only 1 partial response.|Week 0 to week 98||||Weeks||95% Confidence Interval|Mean
1280170|NCT00267488|Secondary|Overall Survival|Kaplan-Meier Estimate. Overall survival is defined as time from start of treatment until death due to any cause. Subjects who are alive at the time of analysis will be censored at the time of last contact.|Week 0 to Week 98|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.|||Weeks||95% Confidence Interval|Mean
1280194|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 12 Months||||ratio||Standard Deviation|Mean
1280172|NCT00267488|Primary|Best Overall Response|Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions|Week 0 to Week 98 when endpoints were met|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.|||Participants|||Number
1280173|NCT00267293|Primary|Child Temperature (Degrees C)Over 6 Hours|Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.|6 hours|Analysis was ITT per sample size calculation at 80% power.|||degrees Celcius||Standard Deviation|Mean
1280174|NCT00267202|Secondary|Number of Participants Requiring 0 to >=5 Doses of Rescue Medications for Systemic Allergic Reactions (SARs) to Specific Immunotherapy (SIT)|Epinephrine for injection, antihistamines, corticosteroids for injection, inhaled beta-agonists, and oral corticosteroids, as well as other drugs used for managing acute allergic reactions to SIT, were available during all study visits. One dose of rescue medication for SAR reactions was equivalent to 1 entry of the CRF page 'concomitant medications/significant non-drug therapies associated with immunotherapy' in response to the question 'Was this medication given in response to a SAR?'|Up to 26 Weeks|Efficacy population: Consisted of all randomized participants who completed the omalizumab or placebo treatment period, received at least one dose of immunotherapy and received rescue therapy.|||participants|||Number
1280175|NCT00267202|Secondary|Number of Participants Requiring 8 to 20 Visits to Complete Cluster Specific Immunotherapy (SIT) Dosing Regimen|During period 3, a cluster dosing protocol was utilized to initiate the allergen immunotherapy (IT). Participants received escalating doses of IT according to a cluster dosing titration regimen. Visits 5 through 13 were cluster visits for this study. The number of visits needed for completion of the cluster SIT dosing regimen was defined as the number of planned visits plus the number of unplanned visits needed to reach maintenance IT dose.|Up to 26 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.|||participants|||Number
1280176|NCT00267202|Secondary|Number of Participants Who Achieved Target Maintenance Specific Immunotherapy (SIT) Dose|Achievement of target maintenance IT dose is defined as answering 'Yes' to the question, 'Was the target maintenance SIT dose achieved?' on Visit 13, Week 16.|16 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.|||participants|||Number
1280177|NCT00267202|Secondary|Severity of First Systemic Allergic Reaction (SAR)|Systemic reactions associated with immunotherapy (IT), defined as occurring within 1 hour following injection of SIT, were graded on a four-point scale: Grade 1: Skin symptoms (generalized urticaria, itching, or erythema), Grade 2: Gastrointestinal symptoms (stomach pain, nausea, or vomiting), Grade 3: Respiratory symptoms (clinically significant nasal symptoms and/or dyspnea, wheezing, persistent cough, etc.), Grade 4: Cardiovascular symptoms (cyanosis, hypotension, collapse, arrhythmias, or angina pectoris).|26 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.|||participants|||Number
1280178|NCT00267202|Primary|Number of Participants With Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT)|The number of participants with Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT). A SAR was captured and recorded as an outcome, not as adverse events (AEs) or SAEs. The primary analysis time point was the end of Period 4 (maintenance immunotherapy). Participants were observed for 1 hour after each immunotherapy (IT) injection visit. Allergic reactions were graded on a 4-point scale from Grade 1 to Grade 4. Grade 1: Skin symptoms, Grade 2: Gastrointestinal symptoms, Grade 3: Respiratory symptoms and Grade 4: Cardiovascular symptoms.|26 Weeks|Efficacy Population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.|||participants|||Number
1280179|NCT00267189|Secondary|Number of Patients With Discontinuation of Study Medication||6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication.|||Patients|||Number
1280180|NCT00267189|Secondary|Percentage of Patients With Efficacy Failure (Biopsy Proven Acute Rejection [BPAR], Graft Loss or Death)|The composite efficacy failure endpoint encompasses at least one of: biopsy proven acute rejection, graft loss, or death for the patient. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy. Acute rejection episodes were recorded as Liver Allograft Rejection. The allograft was presumed to be lost if a patient had a liver retransplant or died.|6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication.|||Percentage of patients|||Number
1280181|NCT00267189|Primary|Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl)|"The primary variable was renal function assessed by calculated creatinine clearance using the Cockcroft-Gault formula, and was assessed at all visits.~CrCl[mL/min] = (140 – A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female."|From baseline to 6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication. Patients with baseline and 6 month creatinine clearance were included in analysis. Missing values at 6 months were imputed using the last observation carried forward (LOCF) approach.|||mL/min||Standard Deviation|Mean
1280182|NCT00267150|Secondary|Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy|Assessed by GI complications at baseline.|week 0|Baseline population|||Participants|||Number
1280195|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 6 Months||||ratio||Standard Deviation|Mean
1280183|NCT00267150|Primary|Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium|The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.|weeks 6-8||||Change in Score of GSRS||Standard Deviation|Mean
1280184|NCT00267111|Secondary|Visual Analogue Scale|Parents and nurses were asked to assess the infant’s pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0=“no pain” on the left side and 10=“worst possible pain” on the right side. Parents and nurses were trained to use the VAS prior to the IM injection.|During the entire procedure|Intention to treat analysis|||Cms||Standard Deviation|Mean
1280185|NCT00267111|Primary|Pain Scores Assessed by Neonatal Facial Action|The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted < 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.|For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds.|Intention to treat analysis|||Percentage of time||Standard Deviation|Mean
1280186|NCT00267098|Secondary|Incidence of Ventricular Tachyarrhythmias|Among subjects implanted with a Cardiac Resynchronization Therapy with Defibrillation device (CRT-D) and randomized, the endpoint was the time from randomization until the subject experienced a ventricular tachyarrhythmia. For each randomization arm, the number of CRT-D subjects who experienced at least one ventricular tachyarrhythmia post-randomization is reported, as well as the number of CRT-D subjects who did not experience one or more ventricular tachyarrhythmias post-randomization.|Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.|"Only randomized subjects in the CRT-D device group were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data recorded by CRT-D devices. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-D: Not Randomized, and all CRT-P subgroups were excluded."|||participants|||Number
1280187|NCT00267098|Secondary|CRT-P and CRT-D System Implant Success|The endpoint will be whether each subject who underwent an implant attempt of a Cardiac Resynchronization Therapy device, be it a pacing only device (CRT-P) or a pacing device with defibrillation capability (CRT-D), had a successful procedure (i.e. the generator, left ventricular lead, and right ventricular lead were successfully implanted). Only one implant attempt was allowed.|Initial Implant Procedure|"For this outcome measure, only subjects in the No Implant Attempt subgroup were excluded."|||participants|||Number
1280188|NCT00267098|Secondary|Clinical Composite Score at 24 Months|The endpoint will be a subject's Clinical Composite Score at 24 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 24 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280189|NCT00267098|Secondary|Clinical Composite Score at 18 Months|The endpoint will be a subject's Clinical Composite Score at 18 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 18 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280190|NCT00267098|Secondary|Clinical Composite Score at 12 Months|The endpoint will be a subject's Clinical Composite Score at 12 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 12 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280191|NCT00267098|Secondary|Clinical Composite Score at 6 Months|The endpoint will be a subject's Clinical Composite Score at 6 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 6 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280196|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 24 month visit. The measure will be the 24 month - randomization visit difference in IVMD.|Randomization to 24 Months||||ms||Standard Deviation|Mean
1280197|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 18 month visit. The measure will be the 18 month - randomization visit difference in IVMD.|Randomization to 18 Months||||ms||Standard Deviation|Mean
1280198|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 12 month visit. The measure will be the 12 month - randomization visit difference in IVMD.|Randomization to 12 Months||||ms||Standard Deviation|Mean
1280199|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 6 month visit. The measure will be the 6 month - randomization visit difference in IVMD.|Randomization to 6 Months||||ms||Standard Deviation|Mean
1280200|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 24 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit value.|Randomization to 24 Months||||liters per minute per squared meter||Standard Deviation|Mean
1280201|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 18 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.|Randomization to 18 Months||||liters per minute per squared meter||Standard Deviation|Mean
1280202|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 12 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit value.|Randomization to 12 Months||||liters per minute per squared meter||Standard Deviation|Mean
1280203|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 6 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit value.|Randomization to 6 Months||||liters per minute per squared meter||Standard Deviation|Mean
1280204|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 24 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 24 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 24 Months||||percentage of left atrial area||Standard Deviation|Mean
1280205|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 18 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 18 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 18 Months||||percentage of left atrial area||Standard Deviation|Mean
1280206|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 12 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 12 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 12 Months||||percentage of left atrial area||Standard Deviation|Mean
1280207|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 6 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 6 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 6 Months||||percentage of left atrial area||Standard Deviation|Mean
1280208|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 24 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 24 Months||||cm||Standard Deviation|Mean
1280209|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 18 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 18 Months||||cm||Standard Deviation|Mean
1280210|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 12 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 12 Months||||cm||Standard Deviation|Mean
1280211|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 6 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 6 Months||||cm||Standard Deviation|Mean
1280212|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 24 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 24 Months||||cm||Standard Deviation|Mean
1280213|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 18 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 18 Months||||cm||Standard Deviation|Mean
1280214|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 12 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 12 Months||||cm||Standard Deviation|Mean
1280215|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 6 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 6 Months||||cm||Standard Deviation|Mean
1280216|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 24 months. For each subject the measurement was calculated as 24 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 24 Months||||grams||Standard Deviation|Mean
1280217|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 18 months. For each subject the measurement was calculated as 18 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 18 Months||||grams||Standard Deviation|Mean
1280218|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 12 months. For each subject the measurement was calculated as 12 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 12 Months||||grams||Standard Deviation|Mean
1280219|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 6 months. For each subject the measurement was calculated as 6 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 6 Months||||grams||Standard Deviation|Mean
1280220|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 24 Months||||ml/square meter of body surface area||Standard Deviation|Mean
1280221|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 18 Months||||ml/square meter of body surface area||Standard Deviation|Mean
1280222|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 12 Months||||ml/square meter of body surface area||Standard Deviation|Mean
1280223|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 6 Months||||ml/square meter of body surface area||Standard Deviation|Mean
1280224|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 24 Months||||ml/square meter of body surface area||Standard Deviation|Mean
1280225|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 18 Months||||ml/square meter of body surface area||Standard Deviation|Mean
1280226|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 12 Months||||ml/square meter of body surface area||Standard Deviation|Mean
1280227|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 6 Months||||ml/square meter of body surface area||Standard Deviation|Mean
1280228|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 24 month - randomization visit difference in LVEF value.|Randomization to 24 Months||||percentage||Standard Deviation|Mean
1280229|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 18 month - randomization visit difference in LVEF value.|Randomization to 18 Months||||percentage||Standard Deviation|Mean
1280230|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 12 month - randomization visit difference in LVEF value.|Randomization to 12 Months||||percentage||Standard Deviation|Mean
1280231|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 6 month - randomization visit difference in LVEF value.|Randomization to 6 Months||||percentage||Standard Deviation|Mean
1280232|NCT00267098|Secondary|Change in Quality of Life at 24 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 24 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 24 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 24 Months||||units on a scale||Standard Deviation|Mean
1280233|NCT00267098|Secondary|Change in Quality of Life at 18 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 18 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 18 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 18 Months||||units on a scale||Standard Deviation|Mean
1280234|NCT00267098|Secondary|Change in Quality of Life at 12 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 12 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 12 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 12 months||||units on a scale||Standard Deviation|Mean
1280235|NCT00267098|Secondary|Change in Quality of Life at 6 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 6 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 6 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 6 Months||||units on a scale||Standard Deviation|Mean
1280236|NCT00267098|Secondary|Cardiovascular-related Healthcare Utilizations|Cardiovascular-related healthcare utilizations (HCUs), such as hospitalizations, Emergency Department visits, urgent care visits, and clinic visits that subjects experienced after being randomized were summarized for each randomization arm|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.||||participants|||Number
1280812|NCT00262522|Secondary|Mean Change From Baseline to Week 96 in CD4+ T Cell Counts||Week 96 (End of Study)|All randomized subjects who received at least 1 dose of study drug and who had CD4+ T cell counts available at both the Baseline Visit and Week 96.|||cells/microliter||Standard Error|Mean
1280237|NCT00267098|Secondary|Frequency of Adverse Events Post-randomization|Adverse events that subjects experienced after they were randomized were compared between arms with regard to several categories such as heart failure (HF)-relatedness, relatedness to the implant procedure, and relatedness to the implanted system, including individual components such as the left ventricular (LV) lead and the CRT-P or CRT-D generator.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.||||participants|||Number
1280238|NCT00267098|Secondary|Change in Cardiovascular Medications|The endpoints are what classes of drugs (e.g. Beta blockers, Diuretics, Nitrates, etc.) each subject was on at the time of scheduled visits (e.g Randomization, 6 months, 12 months, etc.)|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Because indications for defibrillation devices like CRT-Ds are defined by characteristics that relate to medication guidelines, medication results are presented separately for each device group. Medications were assessed only for subjects who completed visits (denoted as Subjects with Medications Assessed)."|||participants|||Number
1280239|NCT00267098|Secondary|Change in Heart Failure Stage|The endpoint is a subject's change in Heart Failure Stage (a measure of the degree of heart failure a subject has on a 4 stage scale (A, B, C, D), with Class A being the healthiest score and Class D being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months.|Randomization to 24 Months|"For each time point(e.g. 6 months), only subjects with HF Stage assessed at randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or HF Stage not assessed) are listed under the Comparative data not available category for that time point."|||participants|||Number
1280240|NCT00267098|Secondary|Change in New York Heart Association Classification|The endpoint is a subject's change in New York Heart Association Classification (a measure of the degree of heart failure a subject has on a 4 class scale, with NYHA I being the healthiest score and NYHA IV being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months post-randomization. The change categories listed will be relative to randomization.|Randomization to 24 Months|"For each time point(e.g. 6 months), only subjects with NYHA assessed at both randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or NYHA not assessed at visit) are listed under the Comparative data not available category for that time point."|||participants|||Number
1280241|NCT00267098|Secondary|Days Hospitalized for Heart Failure|For each subject the endpoint was the days hospitalized for heart failure per patient year, calculated as the total number of days the subject was hospitalized for heart failure divided by the subject's total follow-up time. Only post-randomization data were used.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||Days hospitalized per patient year||Standard Deviation|Mean
1280242|NCT00267098|Secondary|First Heart Failure Hospitalization|The endpoint is the time from randomization to a subject's first heart failure (HF)-related hospitalization. For each randomization arm, the number of subjects who met the endpoint, experiencing at least one heart failure-related hospitalization post-randomization, are reported, as well as the number of randomized subjects who did not experience any HF hospitalizations post-randomization.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280243|NCT00267098|Secondary|All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index|"The endpoint will be the time from randomization to either death or a visit (6, 12, 18, 24 month or interim visit) in which the subject undergoes an echocardiogram and the measured left ventricular end systolic volume index (a measure of the size of the subject's left ventricle normalized over their body surface area) is at least 15% greater than the corresponding measured value at randomization.~Only LVESVI endpoints/deaths and follow-up data occurring before a subject missed an LVESVI measurement (due to missed visit, echo not performed, etc.) were used in the analysis and included in the table below. The counts reflect the number of subjects meeting each endpoint, and are not mutually exclusive."|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280244|NCT00267098|Secondary|All-Cause Mortality or Heart Failure-related Hospitalization|The endpoint will be a subject's time from randomization to either their first heart failure-related hospitalization, or death.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280245|NCT00267098|Secondary|All-Cause Mortality|"The endpoint is the time to death from any cause. The rate of mortality, as measure by the hazard rate, in each randomization arm will be compared.~This outcome includes all post-randomization deaths, whereas the reporting of the primary outcome excluded primary endpoints (including deaths) that occurred after the subject had missed a study-required echocardiogram (used to determine if the LVESVI primary endpoint was met)."|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280814|NCT00262522|Primary|Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48||Week 48|Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.|||Percentage of Subjects|||Number
1280246|NCT00267098|Primary|Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)|Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
1280247|NCT00267085|Primary|Response: One Log Decrease in BCR-ABL|Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.|12 months|All 10 participants on study received treatment and were included in analysis.|||Participants|||Number
1280248|NCT00267059|Primary|Number of Patients in Overall Response Categories|Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.|Evaluated after three 28-day cycles of lenalidomide.|Analysis was intention to treat (ITT): Forty four patients received treatment.|||Participants|||Number
1280249|NCT00267046|Primary|Median Maximum Score for Patient Reported Outcomes in 2 Blinded Cycles|Median maximum score (0 to 10, with 10 being the worst) for participant-reported outcomes in the first 2 blinded cycles for Mouth Pain, Overall Mouth and Throat Soreness, and Rectal Soreness while median maximum score for Swallowing, Drinking and Eating Difficulty (0 to 4, with 4 being the difficult).|Within the first 2 blinded cycles (3-week cycles), up to 6 weeks.|Intention to treat (ITT).|||Units on a scale||Full Range|Median
1280250|NCT00267046|Primary|Cumulative Incidence Rate of Oral Mucositis|"Cumulative incidence of World Health Organization (WHO) grade 2 or > mucositis (moderate to severe) in participants completing up to 6 blinded cycles. Rate defined as participants who had Grade 2 or > divided by total number of participants who completed up to 6 blinded cycles.~WHO Criteria of Grade 1: possible buccal mucosal scalloping with/without erythema; No ulcers; swallows solid diet. Grade 2: ulcers with or without erythema; swallow solid diet. Grade 3: ulcers with/without (extensive) erythema; swallow liquid, not solid diet. Grade 4: mucositis to extent alimentation not possible."|Within 6 blinded cycles (3-week cycles), up to 18 weeks.|Intention to treat (ITT).|||Percentage of Participants||95% Confidence Interval|Mean
1280251|NCT00267007|Secondary|The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.|NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.|baseline to Day 128|MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.|||participants|||Number
1280252|NCT00267007|Primary|The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.|NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.|Baseline to Week 12|MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.|||participants|||Number
1280253|NCT00266877|Secondary|Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer|Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression/death, assessed up to three years.||||weeks||90% Confidence Interval|Median
1280254|NCT00266877|Secondary|Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From start date of response to first PD, assessed up to three years after the first randomization.|Number of subjects with PR or higher response.|||weeks||90% Confidence Interval|Median
1280255|NCT00266877|Secondary|Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer|Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease >= 12 Weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From first dose date to progression/death or last tumor assessment, up to three years.||||percentage of participants||90% Confidence Interval|Number
1280815|NCT00262522|Primary|Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks||Week 8|All randomized subjects who received at least 1 dose of study drug.|||Percentage of Subjects|||Number
1280256|NCT00266877|Primary|Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer|Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression/death or last tumor assessment, up to three years.|modified ITT: Subjects who were randomized and who had taken at least 1 dose of neratinib; equivalent to the safety population|||percentage of participants||90% Confidence Interval|Number
1280257|NCT00266864|Secondary|Resting Energy Expenditure|Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise.|12 months||||kcal/day||Standard Deviation|Mean
1280258|NCT00266864|Primary|Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)|Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the “on-and-off -the-table” method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM.|12 months||||kilograms||Standard Deviation|Mean
1280259|NCT00266825|Secondary|Preterm Births|Percentage of births occurring at less than 37 weeks of gestation.|births before week 37 of gestation||||percentage of births|||Number
1280260|NCT00266825|Secondary|Head Circumference|Measure of circumference of baby's head in centimeters at time of birth.|at time of birth||||centimeters||Standard Deviation|Mean
1280261|NCT00266825|Secondary|Cord RBC-phospholipid-DHA|Percentage of total fatty acids by weight in cord RBC|at time of birth||||percentage of cord RBC||Standard Deviation|Mean
1280262|NCT00266825|Secondary|Gender of Babies||at time of birth||||percentage of babies|||Number
1280263|NCT00266825|Primary|Birth Length|Length of baby at birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.|||centimeters||Standard Deviation|Mean
1280264|NCT00266825|Primary|Birth Weight|Weight of baby at birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.|||grams||Standard Deviation|Mean
1280265|NCT00266825|Primary|Gestational Age|Gestational age of babies at time of birth in days|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.|||days||Standard Deviation|Mean
1280266|NCT00266825|Secondary|Ponderal Index|Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.|at time of birth||||units on a scale||Standard Deviation|Mean
1280267|NCT00266825|Primary|Percentage of Total Fatty Acids by Weight|Measure of RBC-phospholipid-DHA at Birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.|||percentage of fatty acid||Standard Deviation|Mean
1280268|NCT00266812|Primary|Number of Participants With Progression-free Survival (6 Month)|The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as <25% increase in tumor size on CT or MRI.|6 months|Intent to treat (ITT) population (31 of the 35 patients enrolled; 4 participants discontinued prior to start of treatment) was analyzed.|||Participants|||Number
1280269|NCT00266799|Secondary|Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ))|QoL questionnaire was an EORTC QLQ-C30 & SSQ integration. Scores on the SSQ scale ranged from 1 (very much worse) - 7 (very much better). SSQ consisted of 4 items which corresponded to core domains in the 30 Item EORTC QLQ-C30, such as improvement/deterioration in physical functioning, emotional functioning, social functioning, global QoL. Percentages were based on number of participants at each cycle & rounded to the nearest whole number. Early Withdrawal Questionnaires were obtained in 7-14 days of study drug final dose.|From Screening to Day 1 of every Treatment Cycle up to 12 Cycles|ITT: included all randomized participants. There were only a few participants who completed more than 12 cycles due to the longer duration of each cycle.|||Percentage of Participants|||Number
1280270|NCT00266799|Secondary|Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups|Time to treatment failure was defined as the duration of time from the date of the first administration of the study drug to the date of discontinuation of the study drug for any reason.|From Day 1 (Cycle 1) until End of Treatment|ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.|||Months||95% Confidence Interval|Median
1281781|NCT00252174|Secondary|Daily Assessment of Anxiety - the Visual Analog Anxiety Scale (VAAS)|Daily self-report measure for anxiety.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1280271|NCT00266799|Secondary|Overall Survival Time in the PLD and Capecitabine Treatment Groups|Survival time was defined as duration time from onset of treatment with the study drug until death.|From Day 1 (Cycle 1) until Death|ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.|||Months||95% Confidence Interval|Median
1280272|NCT00266799|Secondary|Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups|Overall responses by investigator assessment/RECIST criteria of participant responses; CR=disappearance of target/nontarget lesions + PR=30% decrease in longest diameter sum (noting baseline sum) of target lesions. RECIST used changes in the largest diameter of target/non-target lesions. Target lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. Evaluation of progress was repeated every 3 months (+/-7 days) post first date of lesion measurements, in detection absence until the participant´s death.|From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death|Intent-to-treat (ITT) population included all randomized participants.|||Participants|||Number
1280273|NCT00266799|Primary|Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)|TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or – in the absence of any diagnosis of progressive disease – until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.|From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death|Intent-to-treat (ITT): 7 in PLD group & 3 participants in Capecitabine group were missing response assessments. TTP Population: included participants in view of major protocol violations/deviations, i.e. tumor-relevant inclusion/exclusion criteria, treatment compliance, tumor assessments by RECIST with maximum 4 month interval between assessments.|||Months||95% Confidence Interval|Median
1280274|NCT00266695|Secondary|Number of Participants Receiving Treatment With Panretinal Photocoagulation||Baseline up to Month 24|All enrolled participants.|||participants|||Number
1280275|NCT00266695|Secondary|Number of Participants Receiving Treatment With Focal/Grid Photocoagulation||Baseline up to Month 24|All enrolled participants.|||participants|||Number
1280276|NCT00266695|Secondary|Visual Acuity|Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). A higher score represented better VA.|Month 24|All enrolled participants. Last observation carried forward (LOCF).|||letters read correctly||Standard Deviation|Mean
1280277|NCT00266695|Secondary|Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval|An mSMVL event was defined as a ≥15-letter decrease from Study MBDV baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) during any 6-month period, not just the last 6 months of the study. An mSMVL event was the first occurrence of an mSMVL in a participant, and the time at which the mSMVL began was used as the time of the event for the analysis. VA was measured at 4 meters (m) using an eye chart with 5 letters per row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed.|Baseline up to 6 months, 6 months up to 12 months, 12 months up to 18 months, 18 months up to 24 months, and 24 months up to 30 months|All enrolled participants (pts) at risk during the specified intervals. Pts who did not experience an event during the interval were censored to the last time point in the interval. Number of pts censored: 0 to 6 months = 2 pts, 6 to 12 months = 4 pts, 12 to 18 months = 9 pts, 18 to 24 months = 82 pts, and 24 to 30 months = 90 pts.|||participants|||Number
1280278|NCT00266695|Secondary|Sustained Moderate Vision Loss (SMVL), Long Term|The number of participants who experienced SMVL, long term, in at least 1 diabetic retinopathy (DR) study eye. Long term SMVL was a ≥15-letter decrease from Study MBCM baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of Study MBDV. VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline in Study MBCM, 18 months up to 24 months in Study MBDV (for a total of 75 up to 87 months of SMVL, long term)|Participants who were treated with 32 milligram (mg) ruboxistaurin once daily in Study MBCM and had at least 1 DR study eye, who were also enrolled in Study MBDV.|||participants|||Number
1280289|NCT00266656|Primary|Most Mature Height Standard Deviation Score (SDS)|SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (10 years)|All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.|||standard deviation score||Standard Deviation|Mean
1280279|NCT00266695|Secondary|Vision Loss|The number of participants whose best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in at least 1 diabetic retinopathy (DR) study eye decreased by 15-letters or less from the conclusion of Study MBCM to the start of Study MBDV, 6 to 18 months later. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months|All enrolled participants.|||participants|||Number
1280280|NCT00266695|Primary|Sustained Moderate Visual Loss (SMVL)|The number of participants who experienced SMVL in at least 1 diabetic retinopathy (DR) study eye. SMVL was a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of the study. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline, 18 months up to 24 months|All enrolled participants.|||participants|||Number
1280281|NCT00266656|Secondary|Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)|Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||percentage of participants|||Number
1280282|NCT00266656|Secondary|Percentage of Participants With Prevalence of Abnormal Audiometry Results|Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||percentage of participants|||Number
1280283|NCT00266656|Secondary|Percentage of Participants With Abnormal Tympanometry Results|Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||percentage of participants|||Number
1280284|NCT00266656|Secondary|Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events|Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.|Baseline through End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||percentage of participants|||Number
1280285|NCT00266656|Secondary|Reports of Serious Adverse Events|"Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria).~A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Baseline through End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||events|||Number
1280286|NCT00266656|Secondary|Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years|Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.|Baseline through End of Study (10 years)|All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.|||years||Standard Error|Mean
1280287|NCT00266656|Secondary|Age at Attainment of Tanner 2 Breast Development|The Tanner 2 breast development is the age at first evidence of breast development.|Baseline through End of Study (10 years)|All participants who had a baseline visit and at least one post-baseline visit.|||years||Standard Error|Mean
1280288|NCT00266656|Secondary|Height SDS at Various Ages|SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Age 10, Age 13, Age 16|All participants who had a baseline visit and at least one post-baseline visit.|||Standard deviation score||Standard Deviation|Mean
1280290|NCT00266630|Secondary|Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values|High density lipoprotein: males low 40 milligram/deciliter (mg/dL), high 80 mg/dL; females low 40 mg/dL, high 90 mg/dL. Low density lipoprotein (LDL): males and females low 70 mg/dL, high 139 mg/dL. Hemoglobin A1C (HBA1C): males and females low 4.3%, high 5.8%.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||participants|||Number
1280291|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)|High QTcF: more than or equal to 450 milliseconds (msec) for males; more than or equal to 470 milliseconds (msec) for females|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements and no abnormal values in the direction at baseline (e.g. participants with an abnormally low value for a given parameter at baseline who showed an abnormally low value for the same parameter at a later visit were not included). Last observation carried forward.|||participants|||Number
1280292|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight|Low systolic blood pressure (SBP): <=90 millimeter mercury (mmHg) and decrease of >=20 mmHg; High SBP: >=180 mmHg and increase of >=20 mmHg; Low diastolic blood pressure (DBP): <=50 mmHg and decrease of >=15 mmHg; High DBP: >=105 mmHg and increase of >=15 mmHg; Low pulse: <50 beats per minute (bpm) and decrease of >=15 bpm; High pulse: >120 bpm and an increase of >=15 bpm; Low weight: decrease of >=7%; High weight: increase of >=7%;|baseline through 18 weeks|Analyzed were all study participants.|||participants|||Number
1280293|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes|Triglycerides: high limit equal to or more than 500 milligram/deciliter (mg/dL); Glucose (non-fasting): low limit 2.4975 mmol/liter (L); high limit 13.875 mmol/L; Glucose (fasting): low limit 2.4975 mmol/L; high limit 6.993 mmol/L.|baseline through 18 weeks|Analyzed were all participants without an abnormal value in the direction at baseline (for example, participants with an abnormally low value at baseline who experienced an abnormally low value at any time post baseline were not included, but were included if they experienced an abnormally high value at any time post baseline).|||participants|||Number
1280294|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dyskenisia was defined as a score of equal or more than 2 or an increase of equal to or more than 2 points from baseline on the dyskenisia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.|||participants|||Number
1280295|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dystonia was defined as a score equal or more than 2 or an increase of equal or more than 2 points from baseline on the dystonia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.|||participants|||Number
1280296|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent akathisia was defined as a score of equal or more than 2 or an increase of equal or more than 2 points from baseline on the akathisia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.|||participants|||Number
1280297|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). Parkinsonism is assessed by the total points of items 1 to 5 (total score of 0 to 20). Treatment-emergent parkinsonism was defined as a score of equal or greater than 3 on 1 item, equal or greater than 2 on 2 items, or an increase of equal or greater than 3 from baseline on the parkinsonism total.|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.|||participants|||Number
1280298|NCT00266630|Secondary|Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score|A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by the total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by the points given to the corresponding items.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1280299|NCT00266630|Secondary|Number of Participants Who Switched to Syndromic Depression|As defined as a shift from a Manic Episode at baseline to a Major Depressive Episode, at any post baseline visit, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.|baseline through 18 weeks|Analyzed were all participants who had a manic episode at baseline.|||participants|||Number
1280435|NCT00265850|Primary|Overall Survival|Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.|Up to 5 years post-treatment|All eligible KRAS wild type patients that began treatment were included in this endpoint.|||months||95% Confidence Interval|Median
1280300|NCT00266630|Secondary|Positive and Negative Syndrome Scale Positive Scores - Visit Data|Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For the analysis, the score was converted to 0 to 6 for each item range; hence, the total score ranges from 0 to 42.|baseline, Weeks 1, 2, 4, 6, 10, 14, 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1280301|NCT00266630|Secondary|Number of Participants Who Experienced Remission of Bipolar Disorder|Participants who had equal to or less than 12 points in YMRS total score and equal to or less than 7 points in HAMD-17 total score at 18 weeks. YMRS: 11-item scale, measures the severity of manic episodes. 4 items are rated from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total: 0 to 60. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale or a 5-point scale. HAMD-17 total score: 0 (normal) to 52 (severe).|Week 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||participants|||Number
1280302|NCT00266630|Secondary|Number of Participants With Relapse of Depressive Symptoms|Assessed were participants meeting remission criteria for bipolar disorder in Study BMAC and have a HAMD-17 total score greater than or equal to 13 at any time. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy group who had 12 points or less in the YMRS total score and 7 points or less in the HAMD-17 total score at baseline.|||participants|||Number
1280303|NCT00266630|Secondary|Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)|Incidence of depressive symptoms was defined as a score of equal to or more than 13 points on the HAMD-17. The 17-item HAMD measures depression severity. Each item was evaluated and scored a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline through 18 weeks|Analyzed were all participants who had equal to or less than 7 points on the HAMD-17 total score at baseline.|||participants|||Number
1280304|NCT00266630|Secondary|Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data|Measures severity of the patient's overall severity of bipolar symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline, Weeks 1, 2, 4, 6, 10, 14, 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1280305|NCT00266630|Secondary|Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1280306|NCT00266630|Primary|Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only|Patients achieved remission in Study BMAC (defined as YMRS total score <=12 and HAMD-17 total score <=7) and obtained YMRS total score of >=15 at any time during Study BMEX. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy group who were in remission at baseline (end of Study BMAC) with 12 points or less in YMRS total score and 7 points or less in the 17-item Hamilton Depression Rating Scale total score.|||participants|||Number
1280307|NCT00266630|Primary|Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only|Remission of Mania was defined as a YMRS total score of less than or equal to 12 at endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.|||participants|||Number
1280308|NCT00266630|Primary|Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only|Defined by a 50% or more reduction in YMRS total score from baseline in Study BMAC to endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.|||participants|||Number
1280309|NCT00266630|Primary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|The primary objective was only interested in the effects in the olanzapine monotherapy arm, thus the results for the olanzapine + mood stabilizer arm are presented as secondary outcomes. Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1280310|NCT00266409|Primary|Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.|10 weeks|Per Protocol Population (subjects of ITT population who have no major protocol violations)|||cumulative percent of responders|||Number
1280311|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period|Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||participants|||Number
1280312|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks||8 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280313|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks||7 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280314|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks||6 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280315|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks||5 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280316|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks||4 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280317|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks||3 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280318|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks||2 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280319|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week||1 week|ITT population, but only patients with non-missing assessments were included|||participants|||Number
1280320|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||Units on a scale||Standard Deviation|Mean
1280321|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280322|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280323|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280324|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280325|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280326|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280327|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280328|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280329|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||Units on a scale||Standard Deviation|Mean
1280330|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280331|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280332|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280333|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280334|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280335|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280336|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280337|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280338|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||Units on a scale||Standard Deviation|Mean
1280339|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280340|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280341|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280342|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280343|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280344|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280345|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280346|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280347|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||participants|||Number
1280348|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|8 weeks|ITT population, Last Observation Carried Forward imputation was applied|||participants|||Number
1280349|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|7 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280350|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|6 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280351|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|5 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280352|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|4 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280353|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|3 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280354|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.|2 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280355|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|1 week|ITT population, but only patients with non-missing values are included in the analysis|||participants|||Number
1280356|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280357|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280358|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
1280436|NCT00265798|Secondary|Overall Survival|Overall survival will be defined as time from the start of treatment until death from any cause.|Up to 5 years||||months||95% Confidence Interval|Median
1280359|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 2 weeks|ITT population, but only patients with non-missing values were included|||Participants|||Number
1280360|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||participants|||Number
1280361|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|8 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
1280362|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|7 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
1280363|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|6 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
1280364|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|5 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
1280365|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|4 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
1280366|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|3 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
1280367|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|2 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
1280368|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|1 week|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
1280369|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||Units on a scale||Standard Deviation|Mean
1280370|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 8 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280371|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 7 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280372|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 6 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280373|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 5 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280374|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 4 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280375|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 3 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280376|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 2 Weeks|ITT Population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
1280377|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 1 week|ITT population, but only subjects with values at baseline and time point are included in the analysis|||Units on a scale||Standard Deviation|Mean
1280378|NCT00266409|Primary|Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.|10 weeks|Intent-to-treat population|||cumulative percent of responders|||Number
1280379|NCT00266279|Secondary|Qualitative and Quantitative Toxicity|The most common toxicities were grades 1 or 2 fatigue and anemia .|Every two 28 day treatment cycles||2018-12-31|12/2018||||
1280380|NCT00266279|Primary|Overall Response Rate|"Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.~Overall Response Rate (ORR)=PR+CR."|Every two 28 day treatment cycles until subject no longer on treatment due to disease progression||||Participants|||Number
1280381|NCT00266227|Secondary|Percentage of Retreated Subjects Achieving DAS28-ESR Low Disease at Week 48|The DAS28-ESR score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-ESR scores range from 0 - 10. Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2.|Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Percentage of participants|||Number
1280382|NCT00266227|Secondary|Percentage of Retreated Subjects Achieving DAS28-ESR Remission at Week 48|DAS28-ESR remission was defined as a DAS28-ESR < 2.6|Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Percentage of participants|||Number
1280383|NCT00266227|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) at Week 48 in Retreated Subjects|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all randomized participants, with data available for analyses.|||Score on a scale||Full Range|Median
1280384|NCT00266227|Secondary|Change From Baseline in SF-36 Health Summary Scores at Week 48 in Retreated Subjects|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Score on a scale||Standard Deviation|Mean
1280385|NCT00266227|Secondary|ACRn in Retreated Subjects at Week 48|The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). A positive ACRn Score indicates an improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Score on a scale||Standard Deviation|Mean
1280386|NCT00266227|Secondary|Percentage of Retreated Subjects With a Change ≥ 0.3 From Baseline in HAQ-DI at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Percentage of participants|||Number
1280467|NCT00265473|Primary|Subjects With Full Islet Function.|Proportion of subjects with full islet function (i.e. insulin independent) at one year after initial islet transplant.|At one year after initial transplant.|The number of participants was based on the participants that were actually transplanted.|||Participants|||Number
1280387|NCT00266227|Secondary|Percentage of Retreated Subjects With a Change ≥ 0.22 From Baseline in HAQ-DI at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Percentage of participants|||Number
1280388|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Erythrocyte Sedimentation (ESR) at Week 48|Blood was collected for Erythrocyte Sedimentation Rate, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||millimeter/hour (mm/hr)||Standard Deviation|Mean
1280389|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: C-Reactive Protein at Week 48|Blood was collected for C-Reactive Protein, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.|Baseline, Week 48|Intent-to-treat Population includes all participants randomized to Retreatment.|||mg/dL||Standard Deviation|Mean
1280390|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Assessment of Pain at Week 48|Patients rated their pain at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (none) to 100 (unbearable pain). A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment with data available for analyses.|||millimeter (mm)||Standard Deviation|Mean
1280391|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Physician's Global Assessment of Disease Activity at Week 48|A Rheumatologist or a skilled Arthritis assessor rated the patient's disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||millimeter (mm)||Standard Deviation|Mean
1280392|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Global Assessment of Disease Activity at Week 48|Participants rated their disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||millimeter (mm)||Standard Deviation|Mean
1280393|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Score on a scale||Standard Deviation|Mean
1280394|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Tender Joint Count at Week 48|A Rheumatologist or an skilled arthritis assessor evaluated 68 joints at baseline and at Week 48. A negative change from baseline in the Tender Joint Count indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||Joint Count||Standard Deviation|Mean
1280395|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Swollen Joint Count at Week 48|A Rheumatologist or an skilled arthritis assessor evaluated 66 joints at baseline and at Week 48. A negative change from baseline in Swollen Joint Count indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||Joint Count||Standard Deviation|Mean
1280396|NCT00266227|Secondary|Percentage of Retreated Subjects With a European League Against Rheumatism (EULAR) Response at Week 48|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||Percentage of participants|||Number
1280397|NCT00266227|Secondary|Change From Baseline in Disease Activity Score (DAS28-CRP) at Week 48|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population that includes all participants randomized to Retreatment with data available for analyses.|||Units on a scale||Standard Deviation|Mean
1280411|NCT00266032|Primary|Adjusted Pearl Index|The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year|||Pregnancies per 100 woman years||95% Confidence Interval|Mean
1280398|NCT00266227|Secondary|Change From Baseline in the Disease Activity Score Using 28 Joint Counts (DAS28-ESR) at Week 48|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|48 weeks|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Units on a scale||Standard Deviation|Mean
1280399|NCT00266227|Secondary|Retreated Subjects With American College of Rheumatology 50% (ACR50) Response and American College of Rheumatology 70% (ACR70) Response at Week 48 Relative to Baseline|ACR50 or ACR70 response was defined as a ≥ 50% or 70% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 50% or 70% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||Participants|||Number
1280400|NCT00266227|Primary|Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline|ACR20 response was defined as a ≥ 20% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 20% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.|48 Weeks|Intent-to-treat population includes all participants randomized to Retreatment.|||Participants|||Number
1280401|NCT00266110|Secondary|Generation of Interferon Gamma Positive CD8+T Cells|Evaluate the ability of peptide-pulsed dendritic cells plus trastuzumab to induce functional antigen specific T cells. Measured by percentage of intracellular cytokine staining for interferon gamma positive CD8+ T cells|13 weeks|Three subjects had insufficient samples due to early withdraw from study, and one subject was removed from study before the vaccine was administered.|||percentage of cells||Full Range|Mean
1280402|NCT00266110|Secondary|Generation of E75/E90 Tetramer-positive CD8+ T Cells|Evaluate the ability of peptide-pulsed dendritic cells plus trastuzumab to induce functional antigen specific T cells. Measured by percentage of intracellular cytokine staining for E75/E90 tetramer-positive CD8+ T cells|13 weeks|One patient failed to have blood drawn for correlative studies following second vaccine.|||Percentage||Full Range|Mean
1280403|NCT00266110|Primary|Number of Participants With Response|Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|5-6 years||||Participants|||Count of Participants
1280404|NCT00266032|Post-Hoc|Pearl Index (FDA Criteria)|Following an FDA request another PI evaluation was done for the first year of treatment only and taking into consideration also pregnancies with a conception date within 14 days after end of the study medication. Restricting the analysis to the required first year of treatment, it results in this PI estimation.|Up to one year|FAS|||Pregnancies per 100 woman years||95% Confidence Interval|Mean
1280405|NCT00266032|Post-Hoc|Number of Unintended Pregnancies Including Pregnancies Occuring Within 14 Days After End of Study Medication.|Pregnancies with conception date during treatment and within 14 days after end of study medication were included.|Up to one year|FAS|||Pregnancies|||Number
1280406|NCT00266032|Secondary|Days With Scheduled Versus Unscheduled Bleeding|Days with scheduled and unscheduled bleeding were evaluated for extended regimens only. Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle. Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.|Up to one year|FAS (reflecting ITT), all treated subjects, no imputation|||Days||Standard Deviation|Mean
1280407|NCT00266032|Secondary|Number of Bleeding / Spotting Episodes in 90 Day Reference Period|The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.|Up to one year|FAS (reflecting ITT), all treated subjects, no imputation|||Episodes||Standard Deviation|Mean
1280408|NCT00266032|Secondary|Number of Bleeding / Spotting Days by 90-day Reference Period|The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.|up to 1 year|FAS (reflecting ITT), all treated subjects, no imputation|||Days||Standard Deviation|Mean
1280409|NCT00266032|Secondary|Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days|For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.|up to 1 year|FAS (reflecting ITT population), all treated subjects, no imputation|||Days||Standard Deviation|Mean
1280410|NCT00266032|Secondary|Number of Days With Bleeding Excluding Spotting|The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.|up to 1 year|FAS|||Days||Standard Deviation|Mean
1280412|NCT00266032|Primary|Number of Unintended Pregnancies Due to Method Failure|Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year|||Pregnancies|||Number
1280413|NCT00266032|Primary|Pearl Index|The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year|||Pregnancies per 100 woman years||95% Confidence Interval|Mean
1280414|NCT00266032|Primary|Number of Unintended Pregnancies in Yaz Flexible Arm|Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.|up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year|||pregnancies|||Number
1280415|NCT00266032|Primary|Number of Days With Bleeding Including Spotting|The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.|up to 1 year|Full Analysis Set (FAS) (reflecting Intention To Treat (ITT) population), all treated subjects with data available, no imputation|||days||Standard Deviation|Mean
1280416|NCT00265941|Secondary|2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response|Patients are grouped by the combination of clinical nodal response status and the post-treatment PET/CT finding (negative or positive). Nodal relapse rate is calculated for each group by the cumulative incidence method. Relapse is defined as reappearance of tumor after complete response. If possible, relapse should be confirmed by biopsy.|From randomization to 2 years|Randomized eligible N2-3 patients with follow-up and PET data|||percentage of participants||95% Confidence Interval|Number
1280417|NCT00265941|Secondary|Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF|SUVmax is categorized as high (>median) and low (</=median). All times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional failure (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible N2-3 patients with follow-up and PET data|||percentage of participants||95% Confidence Interval|Number
1280418|NCT00265941|Secondary|Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF|EGFR expression is categorized as high (>/=80%) and low (<80%) in order to compare outcome by favorable and unfavorable risk group, per protocol. Times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional progression (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up and EGFR data.|||percentage of participants||95% Confidence Interval|Number
1280419|NCT00265941|Secondary|Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months|The Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) is a 10-item self-report instrument designed to measure multidimensional quality of life in patients with head and neck cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-40. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-HN including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Change from baseline to 12 months (12 months - baseline) is reported.|Baseline and 12 months|Randomized eligible patients with baseline and 12-month FACT-HN data.|||units on a scale||Standard Deviation|Mean
1280420|NCT00265941|Secondary|Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50|The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient’s responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete.|3 months and 12 months|Randomized eligible patients with PSS-HN data at the given time point.|||proportion of participants||95% Confidence Interval|Number
1280433|NCT00265850|Secondary|Time to Treatment Failure||Up to 5 years post-treatment|||||||
1280434|NCT00265850|Secondary|Progression-free Survival (PFS)|PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.|Up to 5 years post-treatment|All eligible KRAS wild type patients were included in this analysis.|||months||95% Confidence Interval|Median
1280421|NCT00265941|Secondary|Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D)|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state).|3 months and 12 months|Randomized eligible patients with EQ-5D data at the given time point.|||units on a scale||Standard Deviation|Mean
1280422|NCT00265941|Secondary|Rate of Deaths ≤ 30 Days After Discontinuation of Protocol Treatment|Patients who died during treatment or within 30 days after the end of treatment|From start of treatment to 30 days after the end of treatment|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1280423|NCT00265941|Secondary|Rate of Patients Who Tolerated Treatment|A patient was considered to have tolerated treatment if radiation therapy was scored as per protocol or with acceptable variation, they received 2 cycles of cisplatin, and for arm 2, they received the initial dose of cetuximab and at least 5 weekly doses of cetuximab .|From start of treatment to end of treatment (6-7 weeks)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1280424|NCT00265941|Secondary|Rate of Other Toxicity ≥ Grade 3 (Not Mucositis)|Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 other than radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1280425|NCT00265941|Secondary|Rate of Mucositis Toxicity ≥ Grade 3|Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1280426|NCT00265941|Secondary|Local-regional Failure (LRF) (3-year Rate Reported)|Local-regional failure is defined as time from randomization to date of failure (local or regional progression), or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Distant disease progression is considered a competing risk. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases. Three-year rates were estimated by the cumulative incidence method.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1280427|NCT00265941|Secondary|Overall Survival (OS) (3-year Rate Reported)|Overall survival is defined as time from randomization to date of death from any cause. Patients last known to be alive are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1280428|NCT00265941|Primary|Progression-free Survival (PFS) (3-year Rate Reported)|Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1280429|NCT00265889|Primary|Number of Patients That Experience Pulmonary Toxicity|Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.|One year after second transplant|Analysis is per protocol, so includes patients who received treatment|||participants|||Number
1280430|NCT00265889|Primary|Response Rate|Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.|One year after second transplant|Analysis is per protocol, so includes patients who received both transplants|||participants|||Number
1280431|NCT00265889|Primary|Progression-free Survival|Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.|one year after second transplant|Analysis is per protocol, so includes patients who received both transplants|||participants|||Number
1280432|NCT00265850|Secondary|Duration of Tumor Response||Up to 5 years post-treatment|||||||
1280437|NCT00265798|Secondary|Progression-free Survival|"Progression-free survival will be defined as time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death, whichever comes first.~CT scans for disease reassessment will be obtained pre-therapy and every 8 weeks."|Up to 5 years||||months||95% Confidence Interval|Median
1280438|NCT00265798|Primary|Objective Response Rate|"Objective response (complete response (CR)+ partial response (PR)) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of objective response."|Up to 5 years||||percentage of partcipants||95% Confidence Interval|Number
1280439|NCT00265785|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1280440|NCT00265785|Secondary|Response (Confirmed and Unconfirmed, Complete and Partial)|Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.|Eligible and analyzable patients with measurable disease at baseline are included in this measure.|||percentage of participants||95% Confidence Interval|Number
1280441|NCT00265785|Primary|Overall Survival|Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|0 - 3 years|Eligible and analyzable patients were included in this measure.|||months||95% Confidence Interval|Median
1280442|NCT00265785|Secondary|Progression-free Survival|Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 3 years|Eligible and analyzable patients were included in this measure.|||months||95% Confidence Interval|Median
1280443|NCT00265759|Secondary|Overall Survival (Cohort A and B)|Overall survival (OS) will be measured from the date of randomization until the date of death. The distribution of overall survival times will be estimated using the Kaplan-Meier method.|assessed up to 10 years||2022-08-31|08/2022||||
1280444|NCT00265759|Secondary|Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A)|Rate (percentage) of Improved surgical outcome for patients designated as candidates for mastectomy prior to therapy (Cohort A). Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients considered candidates for mastectomy prior to therapy.|||percentage of patients||95% Confidence Interval|Number
1280445|NCT00265759|Secondary|Clinical Response Rate (Cohort B)|The clinical response rate is defined as 100 times the number of eligible patients whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients. A 90% binomial confidence interval will be constructed for the true clinical response rate.|Up to 18 weeks|Outcome Measure Data Not Collected.||||||
1280446|NCT00265759|Secondary|The Pathologic Complete Response (pCR) Rate (Cohort A)|The pathologic complete response is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes. The pathologic complete response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgical specimen is such that there is no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the pCR between these 2 treatments.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients who had surgery performed after completion of AI therapy.|||percentage of patients||95% Confidence Interval|Number
1280447|NCT00265759|Secondary|Rate of Lymph Node Involvement (LNI) (Cohort A)|For those patients who undergo a sentinel lymph node dissection or an axillary lymph node dissection (at least 6 nodes examined with Hematoxylin & Eosin Staining), the LNI rate (percentage) is defined as 100 times the proportion of eligible patients randomized to that treatment with at least one positive node. For each neo-adjuvant endocrine treatment, a 95% binomial confidence interval will be constructed for its true LNI rate.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed include only patients who were evaluated for the number of positive nodes and not evaluated before or during AI therapy.|||percentage of patients||95% Confidence Interval|Number
1280448|NCT00265759|Secondary|Rate of Downstaging to Stage I Determined by Sentinel Node Evaluation (Cohort A)|The rate downstaging to Stage I of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgically findings are such that the maximum dimension of the invasive lesion contained in their surgical specimen is at most 2 cm and their lymph nodes are negative (by Hematoxylin & Eosin Staining) divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the rate of downstaging to Stage I between these 2 treatments.|At time of surgery up to 18 weeks|Outcome Measure Data Not Collected.||||||
1280449|NCT00265759|Secondary|Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A)|The rate (percentage) of improved surgical outcome for patients considered marginal for breast conservation surgery prior to therapy for Cohort A is reported below for each treatment arm. Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients considered marginal for breast conservation surgery prior to therapy.|||percentage of improved surgical outcome||95% Confidence Interval|Number
1280450|NCT00265759|Secondary|Progression-free Survival (PFS) (Cohort A and B)||assessed up to 10 years||2022-08-31|08/2022||||
1280451|NCT00265759|Secondary|Toxicity (Cohort A)|Incidence of the most common grade 3+ toxicities reported to be probably, possibly, or definitely related to treatment as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (Cohort A) At each treatment evaluation, the type, severity, and attribution of each adverse event reported will be assessed using the NCI-CTCAE definitions. For each treatment, the percentage of patients who developed a severe (grade 3+) toxicity considered possibly, probably or definitively related to treatment will be determined.|Up to 30 days after drug therapy||||percentage of patients|||Number
1280452|NCT00265759|Primary|Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B)|The primary aim is to assess the anti-tumor effect in terms of pathologic CR rates of neo-adjuvant chemotherapy in patients with T2-T4c, any N, M0 breast cancer (by clinical staging) who are endocrine therapy resistant (that is, their Ki-67 level is >10 after 2-4 week of neo-adjuvant endocrine therapy alone). The pCR rate (percentage) for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.|Up to 18 weeks|The Overall Number of Participants Analyzed is a subset of the number of patients in Cohort B Arm II: Week 2 Ki67 >10% who switched to neoadjuvant chemotherapy. The remaining number of patients in this arm were not included in this analysis due to decision to either continue with AI therapy or undergo surgery directly.|||percentage of patients||95% Confidence Interval|Number
1280453|NCT00265759|Primary|Clinical Response (Complete or Partial Response) Rate (Cohort A)|The clinical response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients randomized to that treatment. For each treatment arm, a 95% binomial confidence interval will be constructed for the true clinical response rate. Complete Response (CR): The disappearance of all known disease based on a comparison between the measurements at baseline and the Week 16 visit. Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) based on a comparison between the measurements at baseline and the Week 16 visit. In addition there can be no appearance of new lesions or progression of any lesion.|Up to 18 weeks||||percentage of patients||95% Confidence Interval|Number
1280454|NCT00265616|Secondary|Intubation Time in Survivors||Up to 3 months||||days||Full Range|Median
1280455|NCT00265616|Primary|Refractory Status Epilepticus Controlled With First Course of Study Drug|Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)|after return of continuous EEG activity (typically after 36 hours - 5 days)|Number of patients fulfilling primary outcome criteria|||participants|||Number
1280456|NCT00265616|Secondary|Patients With Propofol Infusion Syndrome|Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.|10 days||||participants|||Number
1280457|NCT00265616|Secondary|Patients With Hypotension Requiring Specific Treatment||10 days||||participants|||Number
1280458|NCT00265616|Secondary|Patients With Infectious Complications Requiring Specific Treatment||10 days||||participants|||Number
1280459|NCT00265616|Secondary|Clinical Outcome at Day 21|Return to baseline clinical conditions (i.e.: no new handicap, no death)|21 days||||participants|||Number
1280460|NCT00265512|Secondary|Quality of Life||Psychiatric symptoms and quality of life are measured at baseline, 3 months, 6 months and 12 months after enrollment into the study.|||||||
1280461|NCT00265512|Secondary|Psychiatric Symptoms||Psychiatric symptoms and quality of life are measured at baseline, 3 months, 6 months and 12 months after enrollment into the study.|||||||
1280462|NCT00265512|Primary|Rates of Substance Use|Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).|Rates of substance use measured at 3 months||||percentage of days||Standard Error|Mean
1280463|NCT00265473|Secondary|Insulin Independent Multiple-donor Subjects.|Proportion of insulin independent multiple-donor subjects at one year after final transplant. Participant received more than one islet transplant.|At one year after final transplant||||participants|||Number
1280464|NCT00265473|Secondary|Insulin Independent Single-donor Subjects.|Proportion of insulin independent single-donor subjects at day 75 after transplant|At 75 days after transplant||||Participants|||Number
1280465|NCT00265473|Secondary|Subjects With Partial Islet Function and no Episodes of Severe Hypoglycemia;|Proportion of subjects with partial islet function and no episodes of severe hypoglycemia at one year after initial islet transplant.|At one year after initial transplant||||Participants|||Number
1280466|NCT00265473|Primary|Serious Adverse Events Related to Immunosuppressive Therapy.|Number of serious adverse events related to immunosuppressive therapy.|Day 0 - Day 365||||Serious Adverse Events|||Number
1280468|NCT00265395|Primary|Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.|LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)|48 or 72 weeks of treatment plus 24 weeks of follow-up.|According to the protocol, the efficacy analysis was carried out on all slow responders (ie, patients who had at least 2 log drop in HCV-RNA level at treatment week 12, and undetectable HCV-RNA at treatment week 24).|||Participants|||Number
1280469|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||participants|||Number
1280470|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Attendance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||participants|||Number
1280471|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Situation|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||participants|||Number
1280472|NCT00265382|Secondary|Change From Baseline in Child Health Questionnaire (CHQ)|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280473|NCT00265382|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|"CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the normal range; lower score indicates need for increased supervision."|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280474|NCT00265382|Secondary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280475|NCT00265382|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score|AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280476|NCT00265382|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item|BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280477|NCT00265382|Secondary|Change From Baseline in Simpson-Angus Rating Scale (SARS)|SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280478|NCT00265382|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index|Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280479|NCT00265382|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales|Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280480|NCT00265382|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280481|NCT00265382|Secondary|Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score|CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). Last Observation Carried Forward (LOCF) imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
1280482|NCT00265382|Secondary|Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment|Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 26, Early Termination (ET)|Safety Analysis Set. N=number of subjects with analyzable data at baseline. Baseline data from Study A1281134 (NCT00257192) served as the baseline for A1281135.|||participants|||Number
1280483|NCT00265382|Primary|Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|26 weeks|Safety Analysis Set = all subjects who took at least one dose of study medication. In this table, the number of subjects with AEs is based on a 0% AE threshold whereas the number of subjects with AEs reported in the AE section are based on a 5% AE threshold.|||participants|||Number
1280506|NCT00265317|Secondary|Plasma Concentration of Soluble VEGFR-3 at Baseline||Baseline (Cycle 1, Day 1)|FA Set|||pg/mL||Full Range|Median
1280484|NCT00265343|Secondary|Change in Quality of Life Measured by Quality of Life Scale (QLS)|Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].|Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)|Intent-to-treat population|||Units on a Scale||Standard Error|Least Squares Mean
1280485|NCT00265343|Primary|Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale|Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].|Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)|Intent-to-treat population|||Units on a Scale||Standard Error|Least Squares Mean
1280486|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF - All Subjects|QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)||||participants|||Number
1280487|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF for Females|QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)||||participants|||Number
1280488|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF for Males|QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)||||participants|||Number
1280489|NCT00265330|Primary|Mean Change From Baseline for QTcF Intervals|QT intervals (observed in an electrocardiogram)corrected using Fridericia’s formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.|Baseline to Week 26 (end of study)||||millisecond||Standard Deviation|Mean
1280490|NCT00265330|Primary|Body Mass Index (BMI) Z-score Frequency|change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 26||||participants|||Number
1280491|NCT00265330|Primary|Body Mass Index (BMI) Z-score Frequency|change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 6||||participants|||Number
1280492|NCT00265330|Primary|Mean Change From Baseline for Body Mass Index (BMI) Z-Score|mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 6, 26, early termination||||score on scale||Standard Deviation|Mean
1280493|NCT00265330|Primary|Mean Change From Baseline for Body Weight|Mean change; body weight value at observation minus body weight value at baseline.|Week 6, Week 26||||kilogram||Standard Deviation|Mean
1280494|NCT00265330|Primary|Mean Change From Baseline in Standing Pulse Rates|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||beats per minute||Standard Deviation|Mean
1280495|NCT00265330|Primary|Mean Change From Baseline in Standing Diastolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||mm Hg||Standard Deviation|Mean
1280496|NCT00265330|Primary|Mean Change From Baseline in Standing Systolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||mm Hg||Standard Deviation|Mean
1280497|NCT00265330|Primary|Mean Change From Baseline in Supine Pulse Rates|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||beats per minute||Standard Deviation|Mean
1280498|NCT00265330|Primary|Mean Change From Baseline in Supine Diastolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||millimeters mercury (mm Hg)||Standard Deviation|Mean
1280499|NCT00265330|Primary|Mean Change From Baseline in Supine Systolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||millimeters of mercury (mm Hg)||Standard Deviation|Mean
1280500|NCT00265330|Primary|Change in Hormones|Mean Change: lab value at observation minus lab value at baseline|Week 6, Week 26|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)|||nanogram/deciliter (ng/dL)||Standard Deviation|Mean
1280501|NCT00265330|Primary|Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol|Mean Change: lab value at observation minus lab value at baseline.|Week 6, Week 26|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)|||milligram /deciliter (mg/dL)||Standard Deviation|Mean
1280502|NCT00265330|Primary|Incidence of Lab Abnormalities|number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.|Week 26|Total number of subjects with given laboratory test at given visit. Range: N=136-134, with the exception of Insulin (N=115)|||participants|||Number
1280503|NCT00265330|Primary|Clinical Global Impression of Severity (CGI-S) Change From Baseline|CGI-S Scale:standardized assessment tool to rate severity of subject’s illness; assesses investigator’s impression of subject’s current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).|baseline and 26 Weeks; 26 Weeks LOCF|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)|||score on scale||Standard Deviation|Mean
1280504|NCT00265330|Primary|Young Mania Rating Scale (YMRS) Total Score Change From Baseline|YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.|baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)|||score on scale||Standard Deviation|Mean
1280505|NCT00265317|Secondary|Plasma Concentration of Soluble KIT (sKIT) at Baseline||Baseline (Cycle 1, Day 1)|FA Set|||pg/mL||Full Range|Median
1280510|NCT00265317|Secondary|Number of Participants With BP Greater Than 200/110 mmHg|Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.|Randomization up until Month 17|Per-Protocol Set|||Participants|||Number
1280511|NCT00265317|Secondary|Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)|Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.|Randomization up until Month 17|Per-Protocol Set: all participants in the Phase 2 portion (randomized) who received at least 1 dose of study medication (either erlotinib or blinded medication) with treatment assignments designated according to actual study medication received|||Participants|||Number
1280512|NCT00265317|Secondary|EORTC-QLQ-C30 Lung Cancer Module (LC13) Score|The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)|PRO Analysis Set; n is number of participants with an assessment at the specific time point|||score on a scale||95% Confidence Interval|Mean
1280513|NCT00265317|Other Pre-specified|sKIT Ratio to Baseline at Each Timepoint|Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle|||Ratio||Full Range|Median
1280514|NCT00265317|Secondary|Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score|EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1|Patient-Reported Outcome (PRO) Analysis Set: participants from the FA Set who had at least 1 EORTC QLQ-C30 or EORTC QLQ Lung cancer (QLQ-LC13) module questionnaire assessment while on treatment; n is number of participants with an assessment at the specified time point.|||score on a scale||95% Confidence Interval|Mean
1280515|NCT00265317|Other Pre-specified|VEGFR-3 Ratio to Baseline at Each Timepoint|Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle|||Ratio||Full Range|Median
1280516|NCT00265317|Secondary|PFS in Subgroups That Were Defined by RNA Expression Profile|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
1280517|NCT00265317|Other Pre-specified|VEGFR-2 Ratio to Baseline at Each Timepoint|Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle|||Ratio||Full Range|Median
1280518|NCT00265317|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile|Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set|||Percentage of Participants|||Number
1280519|NCT00265317|Other Pre-specified|VEGF-C Ratio to Baseline at Each Timepoint|Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle|||Ratio||Full Range|Median
1280520|NCT00265317|Secondary|Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts|A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed.|Baseline (Day 1, Cycle 1)|Blood samples were collected; however, because of the small sample size that resulted in a lack of power for statistical testing, no formal statistical analyses were performed.||||||
1280521|NCT00265317|Secondary|Percentage of Participants by Tumor VEGFR Mutation|Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|Full Analysis - All Population; data were not analyzed||||||
1280522|NCT00265317|Secondary|OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms|OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population|||Months||95% Confidence Interval|Median
1280523|NCT00265317|Secondary|PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population|||Weeks||95% Confidence Interval|Median
1280524|NCT00265317|Secondary|Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms|Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A.|Baseline|Full Analysis - All Population|||Percentage of Participants||95% Confidence Interval|Number
1280525|NCT00265317|Secondary|Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms|OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.|From randomization until death (up to Month 17)|Per Protocol Caucasian Population|||Months||95% Confidence Interval|Median
1280526|NCT00265317|Secondary|PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population: all Caucasian participants in randomized phase who received at least 1 dose of study medication (either erlotinib or blinded medication), with treatment assignments designated according to actual study medication received|||Weeks||95% Confidence Interval|Median
1280527|NCT00265317|Secondary|Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms|Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A.|Baseline|Full Analysis - All Population: all participants from lead-in period and Phase 2 (randomized phase)|||Percentage of Participants||95% Confidence Interval|Number
1280528|NCT00265317|Secondary|PFS in Subgroups That Were Defined by KRAS Gene Mutation|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
1280529|NCT00265317|Secondary|Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations|Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported.|Baseline|FA Set|||Percentage of Participants|||Number
1280530|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Mutation|PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
1280531|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Mutation|Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported.|Baseline|FA Set|||Percentage of Participants|||Number
1280532|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Amplification|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
1280533|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Amplification|The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set|||Percentage of Participants|||Number
1281910|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Glucose Evaluations|Patients with glucose values that met low (<=40 mg/dL) or high (>=175 mg/dL) criteria were considered potentially clinically significant.|visit 6 (week 27)|ITT Population|||Participants|||Number
1280534|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase|PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
1280535|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Copy Number Increase|The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured.|Baseline|FA Set|||Percentage of Participants|||Number
1280536|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)|PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
1280537|NCT00265317|Secondary|Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)|Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set|||Percentage of Participants|||Number
1280538|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)|PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
1280539|NCT00265317|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff|Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set|||Percentage of Participants|||Number
1280540|NCT00265317|Secondary|Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||ng/mL||Standard Deviation|Mean
1280541|NCT00265317|Secondary|Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||ng/mL||Standard Deviation|Mean
1280542|NCT00265317|Secondary|Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||ng/mL||Standard Deviation|Mean
1280576|NCT00265200|Primary|Average Percent Change From Baseline in TRAP Levels at 2 Weeks|Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline|TRAP levels at Baseline and 2 weeks after first Zometa infusion|13 of 28 total study participants could not be evaluated: 7 due to sample deterioration; 5 participant non-compliance; 1 withdrew.|||Percent change||Full Range|Mean
1280543|NCT00265317|Secondary|Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||ng/mL||Standard Deviation|Mean
1280544|NCT00265317|Secondary|Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||mcg/mL||Standard Deviation|Mean
1280545|NCT00265317|Secondary|Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above lower limit of quantification (LLOQ) in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||mcg/mL||Standard Deviation|Mean
1280546|NCT00265317|Secondary|Tmax for Total Drug (Sunitinib + SU-012662)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||Hours||Full Range|Median
1280547|NCT00265317|Secondary|Tmax for SU-012662 (Metabolite of Sunitinib)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||Hours||Full Range|Median
1280548|NCT00265317|Secondary|Tmax for Sunitinib||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||Hours||Full Range|Median
1280549|NCT00265317|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib||Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A|||Hours||Full Range|Median
1280550|NCT00265317|Secondary|Sunitinib Clearance at Steady State After Oral Administration (CL/F)||Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Number of participants with calculable data in Original Lead-In Cohort; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 48 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm B.|||L/hr||Standard Deviation|Mean
1280551|NCT00265317|Secondary|Erlotinib Clearance at Steady State After Oral Administration (CL/F)||Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Number of participants with calculable data in Original Lead-In; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 24 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm A.|||Liters (L)/hr||Standard Deviation|Mean
1280552|NCT00265317|Secondary|Plasma Decay Half-life (t1/2) of Sunitinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, t1/2 could not be accurately estimated.||||||
1280553|NCT00265317|Secondary|Plasma Decay Half-life (t1/2) of Erlotinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, t1/2 could not be accurately estimated.||||||
1280554|NCT00265317|Secondary|AUC(0-inf) for Total Drug (Sunitinib + SU-012662)|AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.||||||
1280555|NCT00265317|Secondary|AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)|AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.||||||
1280556|NCT00265317|Secondary|AUC(0-inf) for Sunitinib|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.||||||
1281113|NCT00261443|Secondary|Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3||Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values)|Phase 3 Safety Sample; n=number of participants with measurement at time point|||kg/m^2||Inter-Quartile Range|Median
1280557|NCT00265317|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib|AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC[0-t]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC[t-inf])|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)|Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, AUC(0-inf) could not be accurately estimated.||||||
1280558|NCT00265317|Secondary|Cmax of Total Drug (Sunitinib + SU-012662)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||ng/mL||Standard Deviation|Mean
1280559|NCT00265317|Secondary|Cmax of SU-012662 (Metabolite of Sunitinib)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||ng/mL||Standard Deviation|Mean
1280560|NCT00265317|Secondary|Cmax of Sunitinib||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||ng/mL||Standard Deviation|Mean
1280561|NCT00265317|Secondary|Maximum Observed Plasma Concentration (Cmax) of Erlotinib||Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A|||mcg/mL||Standard Deviation|Mean
1280562|NCT00265317|Secondary|AUC(0-24) of Total Drug (Sunitinib + SU-012662)|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B|||ng*hr/mL||Standard Deviation|Mean
1280563|NCT00265317|Secondary|AUC(0-24) of SU-012662 (Metabolite of Sunitinib)|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B|||ng*hr/mL||Standard Deviation|Mean
1280564|NCT00265317|Secondary|AUC(0-24) of Sunitinib|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B: participants received sunitinib for 28 days each cycle (13 days in Cycle 1) and erlotinib QD for 28 days each cycle (26 days in Cycle 1).|||nanograms (ng)*hr/mL||Standard Deviation|Mean
1280565|NCT00265317|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-in Cohort Arm A: participants received sunitinib QD for 28 days each cycle (27 days in Cycle 1) and erlotinib QD for 28 days each cycle (7 days in Cycle 1)|||micrograms (mcg)*hour(hr)/milliliter (mL||Standard Deviation|Mean
1280566|NCT00265317|Secondary|Percentage of Participants Surviving at 1 Year|Percentage of participants alive at 1 year after date of first administration of study medication.|From randomization until death (up until Month 17)|FA Set|||Percentage of Participants|||Number
1280567|NCT00265317|Secondary|Overall Survival (OS)|OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.|From randomization until death (up to Month 17)|FA Set|||Months||95% Confidence Interval|Median
1280568|NCT00265317|Secondary|Duration of Response (DR)|DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA subset of participants with a confirmed objective response were to be analyzed. As only 3 and 2 responses were observed, duration of response was not analyzed.||||||
1280569|NCT00265317|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
1280570|NCT00265317|Secondary|Percentage of Participants With Objective Response|Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Percentage of Participants||95% Confidence Interval|Number
1280571|NCT00265317|Primary|Progression-Free Survival (PFS)|PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Full Analysis Set (FA):all participants in randomized phase randomized with study medication assignment designated according to initial randomization, regardless of whether participants actually received study medication or received different medication from what they were randomized.|||Weeks||95% Confidence Interval|Median
1280572|NCT00265239|Primary|Nonfatal Ischemic Stroke|number of nonfatal ischemic stroke|415days||||events|||Number
1280573|NCT00265239|Primary|Refractory Angina Pectoris|number of refractory angina pectoris|415days||||events|||Number
1280574|NCT00265239|Primary|Nonfatal Myocardial Reinfarction|number of nonfatal myocardial reinfarction|415days||||events|||Number
1280577|NCT00265122|Secondary|Number of Participants in Population 1 With Clinical Remission at Week 8|The table below shows the number of participants in Population 1 with clinical remission at Week 8 defined a CDAI (Crohn's disease activity index) score < 150 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.|||participants|||Number
1280578|NCT00265122|Secondary|Number of Participants in Population 2 With a Clinical Response at Week 8|The table below provides the number of participants in Population 2 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.|||participants|||Number
1280579|NCT00265122|Primary|Number of Participants in Population 1 With a Clinical Response at Week 8|The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well being. The primary endpoint analysis was based on the comparison between the combined SC and IV Placebo and combined SC and IV ustekinumab treatment groups in Population 1.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.|||participants|||Number
1280580|NCT00265109|Secondary|Body Dysmorphic Disorder Clinical Global Impressions Scale; Hamilton Rating Scale for Depression; Quality of Life Enjoyment and Satisfaction Questionnaire; Social Phobia Inventory; Beck Anxiety Inventory;||Past week|||||||
1280581|NCT00265109|Primary|Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)|The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0–48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response.|Baseline to end week 12|Analyses of the primary outcome measure were intention to treat (ITT) analyses.|||Participants|||Number
1280582|NCT00265096|Secondary|American College of Rheumatology 20 at Week 24|"Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24.~ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])"|Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24|ITT. Patients considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. Wk 16 ACR response was used for patients with change in study treatment.|||P a r t i c ip an t s|||Number
1280583|NCT00265096|Primary|Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24|Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage.|Baseline and Week 24|Intent-to-treat analysis.|||Scores on a scale||Standard Deviation|Mean
1280584|NCT00265096|Secondary|Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14|The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Baseline and Week 14|Intention to treat (ITT). Missing scores were imputed by Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Deviation|Mean
1280585|NCT00265096|Secondary|Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24|Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.|Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24|Intention to treat (ITT). Missing scores were imputed by LOCF. Week (Wk) 16 scores were used for patients with change in study treatment. Week 16 HAQ scores were used for patients with change in study treatment.|||scores on a scale||Inter-Quartile Range|Median
1280641|NCT00264303|Secondary|Mean Score for Pruritus Duration Over the First Week of Treatment|The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.|over the first week of treatment|Intent to treat (ITT) Population|||Units on a scale||Standard Error|Least Squares Mean
1280586|NCT00265096|Secondary|Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline|Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72. Zero (0) means no disease and 72 means maximal disease. PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14.|Baseline, Week 4, Week 8 and Week 14|In a subset of patients with ≥ 3 percent body surface area (BSA) psoriasis skin involvement at baseline. Missing scores were imputed by Last Observation Carried Forward (LOCF).|||Participants|||Number
1280587|NCT00265096|Primary|American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])|Baseline (Week 0), Week 4, Week 8 and Week 14|Intention to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.|||Participants|||Number
1280588|NCT00265083|Secondary|Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14|The Bath Ankylosing Spondylitis Metrology Index (BASMI) is the sum of scores comprised of 5 measures (0=mild, 1=moderate & 2=severe): Tragus-to-wall; Lumbar flexion; Cervical rotation; Lumbar side flexion; Intermalleolar distance. BASMI ranges from 0 to 10. Change from baseline is Wk 14 value minus baseline value.|From Baseline to Week 14|Intent to treat (ITT). Patients considered non-change from baseline in BASMI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASMI at Week 14 was imputed by Last Observation Carried Forward (LOCF).|||Change from baseline in BASMI Index||Standard Deviation|Mean
1280589|NCT00265083|Secondary|Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14|The Bath Ankylosing Spondylitis Functional Index (BASFI) is calculated as the mean of 10 VAS, each of length 0 to 10 cm. Eight of the scales relate to functional capacity of patients while the other 2 relate to a patient’s ability to cope with everyday life. Change from baseline is Wk 14 value minus baseline value.|From Baseline to Week 14|Intent to treat (ITT). Patients considered non-change from baseline in BASFI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASFI at Week 14 was imputed by Last Observation Carried Forward (LOCF).|||Change from baseline in BASFI Index||Inter-Quartile Range|Median
1280590|NCT00265083|Secondary|Assessment in Ankylosing Spondylitis 20 Responders at Week 24|Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 24 at least 3 of the 4 domains: patient global, total back pain, function or inflammation.|Week 24|ITT. Patients (pts) considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ASAS components were imputed by LOCF unless all ASAS components are missing in which case considered non-responders. Wk 16 ASAS response was used for pts with change in study treatment.|||P a r t i c ip an t s|||Number
1280591|NCT00265083|Primary|Assessment in Ankylosing Spondylitis 20 Responders at Week 14|Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation.|Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ASAS components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ASAS components are missing in which case considered non-responders.|||Participants|||Number
1280592|NCT00264875|Primary|Mean Visual Analogue Scale (VAS) Pain Scores|"Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.~Endpoint = last non-missing observation carried forward after Baseline visit."|Baseline, Week 4, Week 8, Week 12, and Endpoint|The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication.|||score on scale||Standard Deviation|Mean
1280593|NCT00264849|Secondary|Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems|The Work Productivity and Activity Impairment-Allergic Asthma (WPAI-AA) questionnaire measures time missed from work, impairment of work and regular activities within the last 7 days. Questionnaires were administered via phone 1 week prior to the study visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Overall work impairment due to asthma problems is derived from the proportion of hours missed from work due to asthma and the degree to which asthma problems affected productivity while working.|Baseline and Week 31|Modified Intent-to-Treat. Only patients only who worked and with values at both baseline and Week 31 visit were included. Sensitivity analysis excluded questionnaires which were answered after the clinic visit.|||percent impairment||Standard Deviation|Mean
1280594|NCT00264849|Secondary|Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31|"The utility-based EQ-5D questionnaire is in two parts and provides a generic measure of health for clinical and economic appraisal. The first health state classification part has 5 questions each with 3 categories (no problem, moderate problem, severe problems). The second visual analogue scale was measured from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline, Week 15, Week 31|Modified Intent-to-Treat with N count as noted in category description.|||units on a scale||95% Confidence Interval|Least Squares Mean
1280642|NCT00264303|Secondary|Mean Pruritus Severity Score Over the Four Weeks of Treatment|Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population|||Units on a scale||Standard Error|Least Squares Mean
1280595|NCT00264849|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit|There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1–totally limited/problems all the time, 7–not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|Baseline, Week 15, Week 31|mITT at Week 15 for OAT + Omalizumab is 214 patients and for OAT is 92 patients; at Week 31 for OAT + Omalizumab is 224 patients and for OAT is 97 patients except as noted in the category description. To be included in this table patients must have a AQLQ measurement for the specified timepoint.|||units on a scale||95% Confidence Interval|Least Squares Mean
1280596|NCT00264849|Secondary|Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32|The type of change for the dose of maintenance systemic steroids could be presented as removal (no more maintenance systemic steroids used), decreased, or maintained.|Weeks 16 and 32|mITT patients with systemic steroids at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6).|||participants|||Number
1280597|NCT00264849|Secondary|Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32|For the subgroup of patients requiring maintenance oral (systemic) corticosteroids throughout the screening period the dose of oral steroid (expressed as prednisolone equivalent dose) at baseline, Week 16 and Week 32 was presented by treatment group, as well as the absolute and percent change from baseline to Weeks 16 and 32. It should be noted that the dose of oral steroid at Weeks 16 and 32 was the dose the patient was maintained on and not the dose to treat an exacerbation if one occurred at that time.|Weeks 16 and 32|mITT patients with systemic steriods at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6). N counts as noted in the category description.|||percent change||Standard Deviation|Mean
1280598|NCT00264849|Secondary|Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period|A combined total of unscheduled visits due to asthma exacerbations was calculated for each patient as the total number of hospital admissions, ER visits and unscheduled outpatient clinical visits due to asthma exacerbation. Where more than one type of visit was required on a single day for an asthma exacerbation only the most serious type was included. Where there was more than one visit for a single asthma exacerbation but the visits occurred on different dates, then all were counted.|32 Weeks|Modified Intent-to-Treat (mITT)|||participants|||Number
1280599|NCT00264849|Secondary|Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period|A clinically significant exacerbation episode was defined as a worsening of asthma requiring treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the rescue systemic corticosteroids marked the start of a clinically significant asthma exacerbation episode and cessation of the rescue systemic corticosteroids regimen marked the end of a clinically significant exacerbation episode. If an exacerbation episode was duplicated, overlapped by at least one day with another episode, or nested within another exacerbation episode, only one exacerbation was counted.|32 Weeks|mITT|||participants|||Number
1280600|NCT00264849|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32|Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ has six questions to be answered by the patient, each with a 7 point scale (0–good control, 6–poor control), and one question where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms.|Baseline, Week 16, Week 32|mITT with N counts as noted in the category description. To be included in this table patients must have a ACQ measurement for the specified timepoint.|||units on a scale||95% Confidence Interval|Least Squares Mean
1280601|NCT00264849|Secondary|Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)|Predicted FEV1 was calculated using the Crapo formula for data at Visit 6 (time of randomization), (MALES: Predicted FEV1 (L) = 0.0414*height - 0.0244*age -2.190 and Females: Predicted FEV1 (L) = 0.0342*height - 0.0255*age - 1.578, where height is in cm).|Weeks 16 and 32|Modified Intent-to-Treat (mITT), for Week 16 N=258/106 for OAT+Omalizumab/OAT and for Week 32 N=266/121 for OAT+Omalizumab/OAT, respectively.|||percent predicted FEV1||95% Confidence Interval|Least Squares Mean
1280602|NCT00264849|Secondary|Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE|Responders were defined as excellent or good based on the patient's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.|Weeks 16 and 32|mITT population and patients who were assessed for persistency of response or non-response at Week 16 and had a GETE obtained >= 4 weeks after the Week 16 assessment or discontinued prematurely or unsatisfactory therapeutic effect >= 4 weeks after the Week 16 assessment. N=187/28 for OAT+Omalizumab/OAT for responders and N=71/63 for non-responders.|||percentage of participants||95% Confidence Interval|Number
1280603|NCT00264849|Secondary|Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32|Number of participants with persistent response, based on the patient's GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks. This is based on the patient's evaluation.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)|||participants|||Number
1280604|NCT00264849|Secondary|Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE|Responders were defined as excellent or good based on the investigator's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)|||percentage of participants||95% Confidence Interval|Number
1280605|NCT00264849|Secondary|Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32|Number of participants with persistent response, based on the investigator’s GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)|||participants|||Number
1280606|NCT00264849|Primary|Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)|Persistency of response, based on GETE, was dichotomized into responders (excellent or good) and non-responders (moderate, poor or worsening). Persistent responders were patients who were responders at 16 weeks and still at 32 weeks. Persistent non-responders were patients who were non-responders at 16 weeks and still at 32 weeks. Patients were assessed for persistency of response if they were responders at Week 16 and had a second GETE obtained ≥ 4 weeks after the Week 16 assessment or discontinued prematurely for unsatisfactory therapeutic effect ≥ 4 weeks after the Week 16 assessment.|Weeks 16 and 32|Modified Intent-to-Treat (mITT) was defined for efficacy analyses which included all randomized patients who had at least one post-baseline efficacy assessment.|||participants|||Number
1280607|NCT00264810|Primary|Change in Frequency of Disabling Seizures|"The outcome measure is met when a significantly greater reduction in the frequency of total disabling seizures in seen in the Treatment group when compared to the Sham group, during the Blinded Evaluation Period (BEP) relative to the Pre-Implant Period (Baseline).~The outcome measure is the group-by-time interaction term in a generalized estimating equation (GEE), longitudinal regression model, where group refers to therapy allocation (Treatment or Sham), time refers to study period (Baseline or BEP), and the dependent variable is seizure frequency. The outcome measure was a statistically significant group-by-time interaction term, which would demonstrate a significantly greater reduction in seizure frequency in the Treatment group than the Sham group during BEP compared to Baseline Period.~Primary Effectiveness Outcome Measure was met.~(Note: Disabling seizures = motor simple partial seizures or complex partial seizures with or without secondarily generalized seizures.)"|3 months pre-implant (Baseline Period) compared to months 3, 4 and 5 post-implant (Blinded Evaluation Period)||||Seizure frequency % change from Baseline||95% Confidence Interval|Number
1280608|NCT00264810|Primary|Short-term Chronic SAE Rate|"RNS® System Short-term Chronic SAE rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 42%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Oh et al., 2002; SSED, Activa Tremor Control System P960009; Beric et al., 2001; Behrens et al., 1997; Hariz, 2002; Joint et al., 2002; Koller et al., 2001).~Primary Safety Outcome Measure was met."|Initial implant through 5 months post-implant||||percentage of subjects with ≥ 1 SAE||95% Confidence Interval|Number
1280609|NCT00264810|Primary|Acute SAE Rate|"RNS® System Acute SAE Rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 15%; upper CI = 20%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Tanriverdi et al., 2009; Wong et al., 2009; Fountas and Smith, 2007; Hamer et al., 2002; Behrens et al., 1997).~Primary Safety Outcome Measure was met."|Initial implant through 1 month post-implant||||percentage of subjects with ≥ 1 SAE||95% Confidence Interval|Number
1280610|NCT00264797|Secondary|Substance Use Outcomes|The mean number of negative urine drug screens (UDS).|20 weeks|All randomized participants.|||negative UDS||Standard Deviation|Mean
1280611|NCT00264797|Secondary|OROS-MPH Abuse Liability|Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.|20 weeks|All randomized participants.|||pills||Standard Deviation|Mean
1280612|NCT00264797|Primary|Substance Use|The change in number of days of substance use from baseline to end of the trial. The number of days of non-tobacco drug/alcohol ascertained using standard timeline follow back (TLFB) procedures.|20 weeks|All randomized participants.|||days||95% Confidence Interval|Mean
1280613|NCT00264797|Primary|ADHD Severity|DSM IV ADHD Rating Scale (ADHD-RS) adolescent informant, ascertained at baseline and weekly throughout the 16 week study. This scale is an 18-item symptom checklist of self-reported adolescent ADHD symptoms. Symptoms are scored as None (0), Mild (1), Moderate (2), and Severe (3), with a summary total of scores for the 18 symptoms. Possible scores range from 0 to 54, with higher scores indicating greater severity. Outcome is measured as the decrease in total severity score over time.|baseline and 20 weeks|All randomized participants.|||units on a scale||Standard Deviation|Mean
1280614|NCT00264641|Primary|Cerebral Activation During Hypoglycaemia|To compare the high RAS activity vs low RAS activity a Z score was used.|After 4 scans on day 1|Only data available is between group analysis|||Z score|||Number
1280615|NCT00264576|Secondary|Number of Subjects Reporting Local and Systemic Reactions|"Safety and tolerability of cTIV and eTIV_f postvaccination.~Difference between demography and safety numbers was due to one misrandomization."|7 days postvaccination|Analysis was done on safety set|||Subjects|||Number
1280616|NCT00264576|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.|Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Titer||95% Confidence Interval|Geometric Mean
1280617|NCT00264576|Secondary|Percentages of Subjects With Seroconversion.|As the definition for seroconversion/significant increase from CHMP guideline CPMP/BWP/214/96 corresponds to that of seroconversion from the May 2007 CBER guidance, the analysis of this immunogenicity endpoint is presented as seroconversion. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40, or prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer, on day 22. CBER criterion is met if the lower limit of the 95% CI for percentages of subjects achieving seroconversion for HI antibody (at least a 4-fold rise in HI antibody titer) postvaccination is ≥40%. CHMP criterion is also met if the percentages of subjects achieving seroconversion is >40%.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Percentages||95% Confidence Interval|Number
1280618|NCT00264576|Secondary|Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.|"Antibody titers as assessed by egg-derived antigen and cell-derived antigen HI assay.~This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70%. According to the US Center for Biologics Evaluation and Research (CBER) guideline, the criterion is also met if the lower limit of the 95% CI for percentages of subjects achieving seroprotection (HI antibody titer ≥1:40) is ≥70%."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Percentages||95% Confidence Interval|Number
1280619|NCT00264576|Secondary|Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method|Antibody titers as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Titer||95% Confidence Interval|Geometric Mean
1280620|NCT00264576|Secondary|Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Ratio||95% Confidence Interval|Geometric Mean
1280621|NCT00264576|Secondary|Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Ratio||95% Confidence Interval|Geometric Mean
1280622|NCT00264576|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.|Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Titer||95% Confidence Interval|Geometric Mean
1280623|NCT00264550|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24|The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline (Week 0) and Week 24|All participants randomly assigned to each treatment group|||Units on a scale||Inter-Quartile Range|Median
1280624|NCT00264550|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14|The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).|Baseline (Week 0) and Week 14|All participants randomly assigned to each treatment group|||Units on a scale||Inter-Quartile Range|Median
1280625|NCT00264550|Secondary|Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24|An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).|Week 24|All participants randomly assigned to each treatment group|||Participants|||Number
1280626|NCT00264550|Primary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24|HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).|Baseline (Week 0) and Week 24|All participants randomly assigned to each treatment group|||Units on a scale||Inter-Quartile Range|Median
1280627|NCT00264550|Secondary|Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14|DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant’s global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).|Week 14|All participants randomly assigned to each treatment group|||Participants|||Number
1280662|NCT00264004|Primary|Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171|Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)|12 week treatment period||||Poportion of Planned Dose||90% Confidence Interval|Median
1280628|NCT00264550|Primary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 14|All participants randomly assigned to each treatment group|||Participants|||Number
1280629|NCT00264537|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline|The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline and Week 52|All participants randomly assigned to each treatment group who had C-reactive protein > 1.0 mg/dl at baseline.|||Scores on a scale||Standard Deviation|Mean
1280630|NCT00264537|Primary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52|The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline and Week 52|All participants randomly assigned to each treatment group.|||Scores on a scale||Standard Deviation|Mean
1280631|NCT00264537|Secondary|Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|Randomized participants with abnormal baseline CRP. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||Participants|||Number
1280632|NCT00264537|Secondary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24|ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 20 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|All participants randomly assigned to each treatment group. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||Participants|||Number
1280633|NCT00264537|Primary|Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|All participants randomly assigned to each treatment group. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||Participants|||Number
1280634|NCT00264498|Primary|Progression Free Survival (PFS)|Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression|Date of randomization to earliest date of objective disease progression||||Days||95% Confidence Interval|Mean
1280635|NCT00264381|Secondary|Change From Baseline to Day 14 in Pain Assessment|Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain|Day 1, Day 14|Participants available at follow up|||units on a scale||Standard Deviation|Mean
1280636|NCT00264381|Primary|Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months|Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.|3 months|Participants available for follow up|||participants|||Number
1280637|NCT00264381|Primary|Thrombosis Progression and Venous Thromboembolism (VTE)|Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing|Day 14|Total number available for follow up|||participants|||Number
1280638|NCT00264381|Secondary|Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.|Number of participants with bleeding events related to treatment|3 months||||participants|||Number
1280639|NCT00264303|Primary|Mean Pruritus Severity Score Over the First Week of Treatment|Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.|over the first week of treatment|ITT population|||Units on a scale||Standard Error|Least Squares Mean
1280640|NCT00264303|Secondary|Mean Score for Pruritus Duration Over the Four Weeks of Treatment|The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population|||Units on a scale||Standard Error|Least Squares Mean
1280663|NCT00264004|Primary|Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171||12 week treatment period||||Participants|||Number
1280643|NCT00264303|Secondary|Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment|CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population|||Units on a scale||Standard Error|Least Squares Mean
1280644|NCT00264303|Secondary|Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment|CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 1st week of treatment.|over the first week of treatment|Intent to treat (ITT) population|||Units on a scale||Standard Error|Least Squares Mean
1280645|NCT00264290|Secondary|Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period||Week 12|||||||
1280646|NCT00264290|Secondary|Change in CMV DNA Shedding After a 4-week Washout Period||Week 12|||||||
1280647|NCT00264290|Secondary|%CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period||Week 12|||||||
1280648|NCT00264290|Secondary|Change in Cluster of Differentiation 4 (CD4) Counts and Plasma HIV RNA Levels at Week 8.||week 8|||||||
1280649|NCT00264290|Secondary|Change in CMV DNA Shedding From Baseline to Week 8.|Change in percentage of participants with detectable CMV DNA. Herpesvirus DNA levels were assessed by polymerase chain reaction (lower limit of detection, 150 copies/mL) on saliva and seminal plasma.|week 8|||||||
1280650|NCT00264290|Primary|Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.|The percentage of activated (CD38+ HLA-DR+) CD8+ T cells was measured on fresh whole blood at screening/baseline. T cell activation was measured on peripheral blood mononuclear cells (PBMCs)in batch at the end of the study.|Baseline, 8 weeks||||percentage of activated T cells||95% Confidence Interval|Mean
1280651|NCT00264238|Secondary|Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a scale of 0 (no symptoms) to 6 (extreme symptoms) and items are summed. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1280652|NCT00264238|Primary|Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)|The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1280653|NCT00264147|Secondary|Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0-mm indicates very well, 100-mm indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treated Population|||Units on a Scale||Standard Deviation|Mean
1280654|NCT00264147|Secondary|Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0 indicates very well, 4 indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population|||Units on a Scale||Standard Deviation|Mean
1280655|NCT00264147|Secondary|Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0-mm indicates very well, 100-mm indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All Patients-Treated Population|||Units on a Scale||Standard Deviation|Mean
1280656|NCT00264147|Secondary|Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)||Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population|||Swollen Joint Count||Standard Deviation|Mean
1280657|NCT00264147|Secondary|Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)||Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population|||Tender Joint Count||Standard Deviation|Mean
1280658|NCT00264147|Primary|Proportion of Patients Who Met the ACR20 Responder Index Criteria|Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)|12 weeks|All-Patients-Treated Population|||Proportion of Patients|||Number
1280659|NCT00264004|Secondary|Best Percentage Change in Tumour Size|Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.|Randomisation until end of treatment period||||percentage of tumor size||90% Confidence Interval|Geometric Mean
1280660|NCT00264004|Secondary|Objective Response Rate|Number of patients with complete or partial response (CR/PR), based on RECIST|12 week treatment period||||Participants|||Number
1280661|NCT00264004|Secondary|Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171||First 6 weeks of 12 week treatment period||||Participants|||Number
1280664|NCT00263887|Secondary|Quality of Life With a Disease Specific Instrument, the St. George's Respiratory Questionnaire||24 or 30 months|||||||
1280665|NCT00263887|Secondary|Mortality||24 or 30 months|||||||
1280670|NCT00263887|Primary|The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung||24 or 30 months|The modified Intent-To-Treat Population was defined as all subjects in the Intent-To-Treat (ITT) Population (all randomized subjects) who had a valid baseline CT scan and at least one valid post-baseline CT scan measurement.|||g/L||Standard Deviation|Mean
1280671|NCT00263757|Secondary|Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)|The FOSQ is a disease-specific quality of life questionnaire to determine functional status in adults. The measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living. There are 30 items on the questionnaire consisting of 5 factor subscales. The subject rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). A higher score indicates greater difficulty or impact of sleepiness on daily living. FOSQ total score ranges from 0 (no difficulty) to 120 (extreme difficulty).|baseline, 12 months|"Usual Care Arm: At the baseline visit 13 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, some due to withdrawals.~Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, due to withdrawals."|||units on a scale||Standard Deviation|Mean
1280672|NCT00263757|Secondary|Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit|The ESS is a measure of general level of sleepiness. The ESS asks subjects to rate their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily live, although not necessarily every day. The questionnaire has 8 questions, with responses ranging from 0 (would never dose) to 3 (high chance of dozing). Therefore the total score could range from 0 (no sleepiness) to 24 (high chance of dozing).|baseline, 12 months|"Usual Care Arm: At the baseline visit 13 participants completed the ESS, and at the 12 month visit 6 participants completed the ESS, due to withdrawals.~Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the ESS, and at the 12 month visit 5 participants completed the ESS, due to withdrawals."|||units on a scale||Standard Deviation|Mean
1280673|NCT00263757|Primary|Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year||1 year||||participants|||Number
1280674|NCT00263666|Secondary|Number of Subjects With the RV in Stool Samples|Number of subjects with presence of RV in stool samples (shedding) collected at pre-determined time points by RV type (Yes, No, Mixed type and results not available [NA]).|From Dose 1 until post Dose 3|Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available|||Participants|||Count of Participants
1280675|NCT00263666|Secondary|Enteric Pathogens Identification.|Number of gastroenteritis (GE) episodes classified by enteric pathogen tests results.|From Dose 1 until 2 months after dose 3 or until end of RV shedding|The analysis was performed on the subjects from the Total Vaccinated Cohort with gastroenteritis episodes reported between the first dose and the last visit and for whom stools were collected|||number of GE episodes|||Number
1280676|NCT00263666|Secondary|Rotavirus Vaccine Strain Identification.|"Number of gastroenteritis (GE) episodes classified by rotavirus vaccine strain/serotype.~Unknown: These samples were typed post hoc and found “G1P8” vaccine type for one subject in HRV group, “G3P8” and “G2P4” for subjects in placebo group."|From dose 1 until 2 months after dose 3 or until end of RV shedding|Analysis was performed on the Total Vaccinated Cohort.|||Number of episodes|||Number
1280677|NCT00263666|Secondary|Rotavirus in Diarrheal Stool Samples|Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode.|From Dose 1 until 2 months after dose 3 or until end of RV shedding|Analysis was performed on the Total Vaccinated Cohort|||Number of episodes|||Number
1280678|NCT00263666|Secondary|Rotavirus Antigen Excretion in Stool Samples|Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end|At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding|The analysis was performed on the According to Protocol Cohort for immunogenicity.|||Participants|||Count of Participants
1280679|NCT00263666|Secondary|Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.||Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity|||titer||95% Confidence Interval|Geometric Mean
1280680|NCT00263666|Secondary|Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value|The cut-off value was ≥ 1:8. The lowest dilution at which serum samples were tested was 1:8, from which a test was considered positive.|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.|||Participants|||Count of Participants
1280681|NCT00263666|Secondary|Geometric Mean Concentration for Anti-BPT Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.|||ELISA-Units/milliliter||95% Confidence Interval|Geometric Mean
1280682|NCT00263666|Secondary|Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter(EL.U/mL).|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.|||Participants|||Count of Participants
1280683|NCT00263666|Secondary|Geometric Mean Concentration for Anti-HBs Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.|||Milli International Units/milliliter||95% Confidence Interval|Geometric Mean
1280684|NCT00263666|Secondary|Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.|||Participants|||Count of Participants
1280685|NCT00263666|Secondary|Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.|||International Units / milliliter||95% Confidence Interval|Geometric Mean
1280686|NCT00263666|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL)|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.|||Participants|||Count of Participants
1280688|NCT00263666|Secondary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.|Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL).|Two months after dose 3|The analysis was performed on the According To Protocol Cohort for immunogenicity|||Participants|||Count of Participants
1280689|NCT00263666|Secondary|Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.|Two months after dose 3|"The analysis was performed on the According To Protocol Cohort for immunogenicity for whom data were available.~In the placebo group, GMCs were all < 20 U/ml, hence values were not computed."|||Units/milliliter||95% Confidence Interval|Geometric Mean
1280690|NCT00263666|Secondary|Number of Subjects With Vaccine Take.|Vaccine take: appearance of serum IgA to rotavirus at a concentration of ≥ 20 U/ml or rotavirus shedding in any stool sample collected from the Screening Visit to 2 months after dose 3 for subjects initially negative for rotavirus.|Two months after the dose 3|Analysis was performed on subjects from the According To Protocol Cohort for immunogenicity for whom data were available|||Participants|||Count of Participants
1280691|NCT00263666|Secondary|Number of Subjects Who Seroconverted Against Rotavirus|A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.|Two months after dose 3|Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available|||Participants|||Count of Participants
1280692|NCT00263666|Secondary|Human Immunodeficiency Virus (HIV) Viral Load|Mean and standard deviation of the base-10 logarithm of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL).|At the screening visit and 2 months after dose 3.|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.|||base-10 logarithm of copies/milliliter||Standard Deviation|Mean
1280693|NCT00263666|Secondary|The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.|Severe suppression: CD4+ cells/microliter (μl) < 750 and CD4+ percent < 15 percent (%); No evidence of suppression: CD4+ cells/μl ≥ 1500 and CD4+ percent ≥ 25%; Moderate suppression = all other CD4+ cell count and CD4+ % combinations.|At the screening visit and 2 months after dose 3 (Visit 4).|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1280694|NCT00263666|Secondary|Number of Subjects Reporting Each Type of Solicited Symptom.|Solicited symptoms included Cough, Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5°C), Irritability, Loss of appetite, and Vomiting.|Within the 15-day solicited follow-up period after each dose|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1280695|NCT00263666|Secondary|Number of Subjects Reporting Any Serious Adverse Events.|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3).|Analysis was performed on the Total Vaccinated Cohort|||Participants|||Count of Participants
1280696|NCT00263666|Secondary|Number of Subjects Reporting Any Unsolicited Symptoms.|An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 30 days after each dose|Analysis was performed on the Total Vaccinated Cohort|||Participants|||Count of Participants
1280697|NCT00263666|Primary|Number of Subjects Reporting Grade “2” or Grade “3” Fever, Vomiting or Diarrhea.|"Symptoms reported in the table include:~Fever: temperature (axillary route) > 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day."|Within the 15-day solicited follow-up period after any dose.|The analysis was performed on the Total Vaccinated Cohort which included the vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1280698|NCT00263328|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire|HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||events||Standard Deviation|Mean
1280699|NCT00263328|Secondary|Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale|"ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
1280700|NCT00263328|Secondary|End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale|"ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
1280701|NCT00263328|Secondary|Change From Baseline in SF-36 v2 Subscale Scores by Visit|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
1280702|NCT00263328|Secondary|SF-36 v2 Subscale Scores by Visit|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
1280703|NCT00263328|Secondary|Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
1280704|NCT00263328|Secondary|Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale|"The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||score on a scale||Standard Deviation|Mean
1280705|NCT00263328|Secondary|Trough Levels of Tacrolimus (ng/mL) by Visit||Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||ng/mL||Standard Deviation|Mean
1280706|NCT00263328|Secondary|Tofacitinib Concentrations in Plasma (ng/mL) by Visit||Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||ng/mL||Standard Deviation|Mean
1280707|NCT00263328|Secondary|Fasting Serum Glucose Levels (mg/dL) by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1280708|NCT00263328|Secondary|HOMA Insulin Resistance (IR) by Visit|HOMA-IR=fasting serum insulin*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement.|Months 12 and 24|Safety population; n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.|||HOMA-IR||Standard Deviation|Mean
1280709|NCT00263328|Secondary|AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit|The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.|Months 12 and 24|Safety population: n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.|||microU*h/mL||Standard Deviation|Mean
1280710|NCT00263328|Secondary|Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit|Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.|Months 12 and 24|Safety population; n=number of participants eligible for OGTT with data (non-missing) at that particular visit.|||mg*h/dL||Standard Deviation|Mean
1280711|NCT00263328|Secondary|Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit|Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement.|Months 12 and 24|Safety population; n=number of participants eligible for OGTT and had data (non-missing) at that particular visit.|||ratio of serum proinsulin to insulin||Standard Deviation|Mean
1280712|NCT00263328|Secondary|Homeostatic Model Assessment (HOMA)-%B by Visit|HOMA-%B = (20 times [*] fasting serum insulin) divided by (/) (fasting serum glucose minus [-] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements.|Months 12 and 24|Safety population; n=number of participants who were eligible for OGTT and had data (non-missing) at that particular visit.|||%B||Standard Deviation|Mean
1280713|NCT00263328|Secondary|Hemoglobin A1c (HbA1c) Levels by Visit||Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||% HbA1c||Standard Deviation|Mean
1280715|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit|Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280716|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit|Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280717|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit|Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for â‰¥6 consecutive weeks, or death.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280718|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit|Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280719|NCT00263328|Secondary|Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN|Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).|Months 12, 18, 24, 36, 48, 60, 72, 84, and 96|FAS|||percentage of participants|||Number
1280720|NCT00263328|Secondary|Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR|Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included.|Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98)|FAS|||percentage of participants|||Number
1280721|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit|Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280722|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit|Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280723|NCT00263328|Secondary|Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit|Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280724|NCT00263328|Secondary|BK Virus (BKV) DNA Levels Determined Using PCR by Visit|Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||number of copies/PCR||Standard Deviation|Mean
1280725|NCT00263328|Secondary|Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit|EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and >1000 copies/PCR.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280726|NCT00263328|Secondary|Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit|Calculated as number of copies per 500 mg DNA.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||number of copies/500 mg DNA||Standard Deviation|Mean
1280727|NCT00263328|Secondary|Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280728|NCT00263328|Secondary|Percentage of Participants Requiring Anti-Hypertensive Medication by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280729|NCT00263328|Secondary|Percentage of Participants Requiring Lipid-Lowering Agents by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280730|NCT00263328|Secondary|Serum Triglyceride Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1280731|NCT00263328|Secondary|Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280732|NCT00263328|Secondary|Ratio of Serum LDL Level to HDL Level by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||ratio||Standard Deviation|Mean
1280733|NCT00263328|Secondary|Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280734|NCT00263328|Secondary|Ratio of Total Serum Cholesterol Level to HDL Level by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||ratio||Standard Deviation|Mean
1280735|NCT00263328|Secondary|High-Density Lipoprotein (HDL) Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1280736|NCT00263328|Secondary|Low-Density Lipoprotein (LDL) Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1280737|NCT00263328|Secondary|Total Cholesterol Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1280738|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit|Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels â‰¥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose â‰¥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose â‰¥200 mg/dL during an OGTT (Oral Glucose Tolerance Test).|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. Participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis.|||percentage of participants|||Number
1280739|NCT00263328|Secondary|Reciprocal of Serum Creatinine||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||dL/mg||Standard Deviation|Mean
1280740|NCT00263328|Secondary|Calculated GFR Using Cockcroft-Gault Equation (mL/Min)|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
1280741|NCT00263328|Secondary|Calculated GFR Using the Nankivell Equation (mL/Min)|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine [in millimoles per liter (mmol/L)]) plus (0.25*body weight [in kilograms (kg)]) minus (0.5*serum urea [mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea]) minus (100 per height [in meters] square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
1280742|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit|Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Full Analysis Set (FAS): all participants who received at least 1 dose of study medication. n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280743|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit|Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280744|NCT00263328|Primary|Percentage of Participants With Hypertriglyceridemia by Visit|Hypertriglyceridemia was defined as triglyceride levels of >200 mg/dL or 2.3 mmol/L.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280745|NCT00263328|Primary|Percentage of Participants With Hypercholesterolemia|Hypercholesterolemia was defined as cholesterol levels >240 mg/dL or 6.2 mmol/L.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1280746|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit|Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (â‰¥)30 days.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis. n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280747|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit|Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
1280748|NCT00263328|Primary|Serum Creatinine Levels||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1280749|NCT00263328|Primary|Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine [in milligrams per deciliter (mg/dL)])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen [BUN] concentration [mg/dL])^(-0.170) * (serum albumin concentration [in grams per dL (g/dL)])^(0.318). A normal GFR is >90 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min/1.73 m^2||Standard Deviation|Mean
1280750|NCT00263211|Secondary|Progression Free Survival||Maximum of 6 months|This trial was terminated early due to futility, subjects were not followed for progression free-survival.||||||
1280751|NCT00263211|Secondary|Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups|Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups|Baseline, 2 weeks and 1 month|Mean Platelet inhibition Denominator for Plavix & Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for control group baseline n=24 , 2-weeks n=19, 1 month n=23|||percentage of platelet inhibition||Standard Deviation|Mean
1280752|NCT00263211|Secondary|Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups|Mean platelet inhibition vs. time plotted for Plavix & Aspirin Arm and Observation group. Citrated whole blood is added to a test carriage containing fibrinogen-coated beads and a platelet activator (arachidonic acid to synthesize thromboxane A2). Using a turbidimetric-based optical detection system, aggregation of activated platelets to fibrinogen-coated beads increase light transmittance which is reported in Aspirin Reaction Units (ARU).|Baseline, 2 weeks and 1 month|Denominator for Plavix & Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for Observation only arm baseline n=24 , 2-weeks n=19, 1 month n=23|||Aspirin Reaction Units||Standard Deviation|Mean
1288259|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6|Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6|Month 6||||L||Standard Error|Mean
1280753|NCT00263211|Secondary|Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time|Percent of patients with a given number/range of CTCs ( 0, 1-5 >+ 5) vs. time baseline 2-weeks and 1 month for plavix & Aspirin arm and observation only|Baseline, 2 weeks and 1 month|Denominator for Plavix & Aspirin arm at Baseline=22, at 2 weeks =20, at 4 weeks =19 Denominator for Observation only at Baseline=24, at 2 weeks=19, at 4 weeks =23|||percentage of participants|||Number
1280754|NCT00263211|Primary|Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug|Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.|Maximum of 6 months|Plavix and Aspirin: 1 patient withdrew consent prior to starting 1 patient died prior to starting|||participants|||Number
1280755|NCT00263211|Primary|Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs|Measured by number of patients who have detectable circulating tumor cells|Week 4|Plavix & Aspirin arm has 19 evaluable patients. 5 withdrew before 1-month data collection: death n=1 and withdrawal of consent n=1 prior to starting; surgery plans n=1; patient preference n=1; platelet inhibition use n=1; Observation only arm had 23 evaluable patients ; 1 patient withdrew during the first month due to disease progression.|||participants|||Number
1280756|NCT00262964|Primary|Change From Baseline in Hepatic Insulin Sensitivity Index|Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index (HISI) is measured as the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||[10000/(μmol/min)x(mU/L)]||Standard Error|Mean
1280757|NCT00262964|Primary|Change From Baseline in Skeletal Muscle Insulin Sensitivity|Changes in skeletal muscle insulin sensitivity (SMIS). SMIS was measured as the increase in skeletal muscle glucose uptake from time zero to the end of a nine hour euglycemic clamp and insulin infusion study. This increase is the percentage change from time zero to end of insulin infusion at nine hours.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||percent increase||Standard Error|Mean
1280758|NCT00262964|Primary|Adipose Tissue Insulin Sensitivity in Fenofibrate and Niacin Groups|The baseline and post-treatment measures of adipose tissue insulin sensitivity (ATIS) were compared. ATIS at both timepoints is the suppression from fasting levels of free fatty acid release from adipose tissue (lipolysis) during an insulin infusion as part of a euglycemic clamp study. It is the percent decrease from time zero to the end of the nine hour euglycemic hyperinsulinemic clamp|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)||||percent decrease||Standard Error|Mean
1280759|NCT00262964|Secondary|Change From Baseline in Very Low-density Lipoprotein Triglyceride Concentration|Change from baseline in very low-density lipoprotein triglyceride concentration (VLDL-Tg)|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||mmol/l||Standard Error|Mean
1280760|NCT00262964|Secondary|Change From Baseline in VLDL-Tg Production Rate|VLDL-TG production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||(μmol/L/min)||Standard Error|Mean
1280761|NCT00262964|Secondary|Change From Baseline in VLDL-Tg Clearance Rate|Very low density lipoprotein triglyceride (VLDL-Tg) clearance rate, a measure of VLDL-triglyceride removal from plasma per minute.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||(ml/min)||Standard Error|Mean
1280762|NCT00262964|Secondary|Change From Baseline in Very Low Density Lipoprotein Apolipoprotein B Production Rate|VLDL-apolipoprotein B (apoB) concentrations were measured as part of a VLDL metabolism study utilizing stable isotope tracers. VLDL apoB production rate, a measure of hepatic secretion of VLDL-apolipoproteinB-100 per liter of plasma per minute.|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)||||nmol/l/min||Standard Error|Mean
1280763|NCT00262964|Primary|Hepatic Fat Content for Fenofibrate and Niacin Groups|Hepatic fat content as measured by magnetic resonance spectroscopy. A PRESS sequence was used. The results from three 10 cubic centimeter voxels positioned within the liver were averaged. The measure is a ratio of triglyceride signal to total signal.|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)|10 (or more) subjects in each group would be sufficient for detecting changes in IHTG.|||ratio||Standard Deviation|Mean
1280764|NCT00262964|Primary|Adipose Tissue Insulin Sensitivity|The ability of insulin to suppress the release of fatty acids from adipose tissue: Adipose tissue insulin sensitivity, measured as the suppression from baseline of free fatty acid release from adipose tissue (lipolysis) during insulin infusion as part of a nine hour euglycemic hyperinsulinemic clamp study.|baseline cross-sectional data pre and post nine hour euglycemic clamp||||percent decrease||Standard Error|Mean
1280765|NCT00262964|Primary|Percent Increase in Skeletal Muscle Insulin Sensitivity During Insulin Infusion.|A precise measure of the ability of insulin to stimulate glucose uptake by skeletal muscle. Skeletal muscle insulin sensitivity, measured as the increase from baseline in skeletal muscle glucose uptake during insulin infusion(percentage)as part of a nine hour euglycemic hyperinsulinemic clamp study.|baseline cross-sectional data pre and post nine hour euglycemic clamp||||percent increase||Standard Error|Mean
1280766|NCT00262964|Secondary|Very Low Density Lipoprotein - Triglyceride Production Rate|Very low density lipoprotein triglyceride (VLDL-TG) production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute (μmol/L/min).|baseline cross-sectional data||||μmol/L/min||Standard Error|Mean
1280767|NCT00262964|Primary|Hepatic Insulin Sensitivity Index (HISI)|Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index(HISI) is the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.|baseline cross-sectional data|number of subjects determined by power calculations. Analysis was per protocol. Intrahepatic triglyceride was determined by magnetic resonance spectroscopy.|||[10000/(μmol/min)x(mU/L)]||Standard Error|Mean
1280769|NCT00262951|Primary|Number of Patients in Whom Tumor Was Resectable|Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.|Up to 5 Years or Until Disease Progression||||Participants|||Number
1280770|NCT00262925|Secondary|Overall Survival|Time from registration to death from any cause. Patients alive were censored at follow up.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry||||months||95% Confidence Interval|Median
1280771|NCT00262925|Primary|Complete Response Rate|"Complete response requires that all of the following be present for at least four weeks.~1. Peripheral Blood Counts: Neutrophil count >= 1.0 x 109/L, Platelet count >= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood.~2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines, <= 5% blasts.~3. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present."|assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry|all enrolled patients|||percentage of participants||95% Confidence Interval|Number
1280772|NCT00262873|Secondary|Average Number of Leukemia Forming Units in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|baseline bone marrow was only available on 5 participants|||number of colonies per 50000 cell plated||Standard Deviation|Mean
1280773|NCT00262873|Secondary|Average Number of Erthroid Burst Forming Units in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|analysis was performed on only four participants|||number of colonies per 50000 cell plated||Standard Deviation|Mean
1280774|NCT00262873|Secondary|Average Number of Colony Forming Unit-granulocyte-macrophages in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|baseline marrow samples were available only 5 participants|||number of colonies per 50000 cell plated||Standard Deviation|Mean
1280775|NCT00262873|Secondary|Average Percentage of Light Density Cells in Apoptosis|The CD34+ fraction of light density marrow obtained from patients at baseline and while receiving bortezomib were assessed through measurement of Annexin V (assay obtained form R&D Systems) and by flow cytometry analysis.|day 14|marrow samples were not available on all participants at baseline|||percentage of apoptotic cells||Standard Deviation|Mean
1280776|NCT00262873|Secondary|Vascular Endothelial Growth Factor (VEGF) Levels in Serum|VEGF levels were measured by ELISA (R&DSystems) in serum from participants exposed to bortezomib. Levels were measured at Day 0 and Day 14 of cycle 1 of the clinical trial.|day 14|data was only available on 5 participants|||pg/ml||Standard Deviation|Mean
1280777|NCT00262873|Secondary|Interleukin 6 Levels in Serum|"interleukin-6 levels were measured by enzyme-linked immunosorbant assay ELISA in serum from participants exposed to bortezomib.~Levels were measured at Day 0 and Day 14 of cycle 1 of the clinical trial."|day 14|data was only available on 5 participants|||pg/ml||Standard Deviation|Mean
1280778|NCT00262873|Primary|Number of Participants Who Experienced Cytopenias||21 Days/course for up to 12 courses|This data was not collected.||||||
1280779|NCT00262873|Primary|Number of Participants Who Experienced an Adverse Event||For 21 days/course for up to 12 courses|patients enrolled to receive study drug|||participants|||Number
1280780|NCT00262860|Secondary|Change in Proteasome Activity Compared to Baseline (Cycle 2)|Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.|baseline and 1-2 weeks after cycle 2, day 11|Samples were not collected on one patient, so only 17 patients were analyzed.|||percentage of change in proteosome activ||Full Range|Median
1280781|NCT00262860|Secondary|Change in Proteasome Activity Compared to Baseline (Cycle 1)|Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.|baseline to 2 hours|Samples were not collected on one patient, so only 17 patients were analyzed.|||Percentage of change in proteosome activ||Full Range|Median
1280782|NCT00262860|Primary|Response Rate After 2 Courses of Therapy|Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG–PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG–PET images) to below three on posttreatment FDG–PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).|21 Days/course for up to 2 courses||||participants|||Number
1280783|NCT00262847|Secondary|Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)|Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.|At baseline, 9, 18, 36, 60, and 84 weeks|Number of valid QOL assessments do not total number of patients randomized in study.|||units on a scale||Standard Deviation|Least Squares Mean
1280784|NCT00262847|Secondary|Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Eligible and Evaluable patients|Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
1280785|NCT00262847|Secondary|Overall Survival|Median overall survival (OS)|From study entry to death or last contact, up to 6 years||||months||95% Confidence Interval|Median
1280786|NCT00262847|Primary|Progression-free Survival|Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).|From study entry until first disease progression, death or date of last contact, up to 6 years||||months||95% Confidence Interval|Median
1280787|NCT00262834|Secondary|Change in Blood (Peripheral Blood Mononuclear Cells) Histone Acetylation After 3 Days of Treatment|To evaluate baseline and change in histone acetylation in polymononuclear cells in patients with primary breast cancer who received three days of SAHA 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment.|Baseline and after 3 day of Vorinostat|No data was collected for this outcome. We were not able to successfully dissolve the pellet in lysis buffer, and the samples were not subjected to histone acetylation analyses.||||||
1280788|NCT00262834|Secondary|Change in Tissue Histone Acetylation After 3 Days of Treatment|To evaluate change from baseline in tissue histone acetylation in patients with primary breast cancer who received three days of Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment. This is measured by Cumulative Methylation Index, which is reported as the sum of all %M for all genes. %M= (methylated copies divided by methylated + unmethylated copies) x 100.|Baseline and after 3 day of Vorinostat|25 matched samples were collected; however, only 19 were available for analysis as there were 6 cases that were not evaluable for Cumulative Methylation Index.|||Cumulative Methylation Index|||Number
1280789|NCT00262834|Primary|Change in Tissue Apoptosis After 3 Days of Treatment|Change in cleaved caspase-3 (a marker of tissue apoptosis) by IHC compared to baseline in the treated (19 evaluable samples) or untreated patients (12 evaluable samples) were analyzed between groups. Cleaved caspase-3 is a protein in cells involved in apoptosis (cell death).|Baseline and after 3 day of vorinostat|Matched samples (ie, diagnostic biopsy and surgical tissues) for cleaved caspase-3 by IHC were available from 19 (71%) treated and from 12 (48%) controls.|||percentage of change|Evaluable tissue samples|Full Range|Mean
1280790|NCT00262834|Primary|Change in Tissue Proliferation After 3 Days of Treatment|Change in Ki-67 (a marker of tissue proliferation) by IHC compared to baseline in the treated (22 evaluable samples) or untreated patients (15 evaluable samples) were analyzed between groups. Ki-67 is a protein in cells that increases as cellsprepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. The more positive cells there are, the more quickly they are dividing and forming new cells.|After 3 days of vorinostat|Matched samples (ie, diagnostic biopsy and surgical tissues) for Ki-67 by IHC were available from 22 (92%) treated and from 15 (60%) controls.|||percentage of change|Evaluable tissue samples|Full Range|Mean
1280791|NCT00262834|Primary|Number of Participants With Adverse Events|Participants were evaluated for adverse events due to vorinostat to assess if it was safe to give the drug prior to surgery. 17 of 25 participants who received vorinostat experienced at least 1 adverse event believed to be related to the study drug; no adverse events were severe, and the treatment was considered safe.|After 3 days of vorinostat|Participants who received at least one dose of vorinostat.|||participants|||Number
1280792|NCT00262821|Secondary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.|All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported|All Treated Patients|||participants|||Number
1280793|NCT00262821|Secondary|Overall Survival|The observed length of life from entry into the study to death or date of last contact.|From study entry to death or last contact, up to 6 years|Eligible and evaluable patients|||percentage of patients alive|||Number
1280813|NCT00262522|Secondary|Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96||Week 96 (End of Study)|Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.|||Percentage of Subjects|||Number
1280794|NCT00262821|Primary|Progression-free Survival - Percentage of Patients Alive and Progression Free|Patients’ progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.|From study entry until first disease progression, death or date of last contact, up to 6 years|Eligible and evaluable patients|||percentage of patients|||Number
1280795|NCT00262743|Other Pre-specified|24 Month Treatment Free Survival Rate|Percentage of participants who were alive and treatment (for progressive CLL) free at 24 months. The 24 month treatment free survival, with 95% CI, was estimated using the Kaplan-Meier method.|24 months (from registration)|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.|||percentage of participants||95% Confidence Interval|Number
1280796|NCT00262743|Secondary|Number of Participants With a Confirmed Complete Response (CR)|A confirmed complete response is a CR which is reported on 2 consecutive cycles at least 4 weeks apart. CR is defined in Primary Outcome Measure #1.|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.|||participants|||Number
1280797|NCT00262743|Primary|Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart|Bio-R: A reduction in the absolute lymphocyte count (ALC) of more than 20% from the pretreatment level for at least 2 months or a >= 30% reduction in all palpable lymphadenopathy without meeting the NCIWG criteria for PR was required|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.|||participants|||Number
1280798|NCT00262743|Primary|Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart|"National Cancer Institute working group criteria (NCIWG) was used to assess response.~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.|||participants|||Number
1280799|NCT00262730|Primary|Survival|survival time is defined from time of histological diagnosis to death occurrence.|30 months|all patients who were treated were analyzed (intent to treat)|||months||95% Confidence Interval|Mean
1280800|NCT00262639|Secondary|Regional Brain Activity on fMRI||Week 2|||||||
1280801|NCT00262639|Secondary|Acoustic Startle Response||Day 1, Day 3, Week 1|||||||
1280802|NCT00262639|Secondary|Sleep||Weeks 1 to 6, 10 and 14|||||||
1280803|NCT00262639|Primary|Percent Days Abstinent|percent days abstinent during treatment|Weeks 1 to 6, 10 and 14||||percent days||Standard Deviation|Mean
1280804|NCT00262639|Primary|Alcohol Withdrawal Scores (CIWAar)||Day 1 Day 2 Week 1|||||||
1280805|NCT00262639|Primary|Percent Subjects Completely Abstinent|percent of subects completely abstinent during the study|16 week trial||||percent of participants|||Number
1280806|NCT00262600|Secondary|Abnormal Liver Function Test|Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN|36 months|Safety set - all subjects who were randomized and received at least 1 dose of study drug|||participants|||Number
1280807|NCT00262600|Secondary|Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)|Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)]|||Number
1280808|NCT00262600|Secondary|Bleeding Events (Major and Minor)|"Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25~Major bleeds are adjudicated, whereas minor bleeds are investigator reported."|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)|||Number
1280809|NCT00262600|Secondary|Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death|Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)|||Number
1280810|NCT00262600|Secondary|Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death|Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)|||Number
1280811|NCT00262600|Primary|Yearly Event Rate for Composite Endpoint of Stroke/SEE|Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)|||Number
1281911|NCT00250679|Secondary|Number of Participants With New 24-Hour Holter Monitoring Alerts|New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline.|Visit 6 (week 27)|ITT Population|||Participants|||Number
1280816|NCT00262509|Primary|Time to Exit Building|Subjects are walked into a building to a specific location and then asked to find their way out of the building. Time to Exit Building is measured. This is protocol is performed twice, and the times averaged to obtain the outcome measure.|30 minutes total, 15 minutes for each of two timed trials|Total number of participants completing study|||seconds|Participants|Standard Deviation|Mean
1280817|NCT00262314|Primary|Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose • Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI • SAE, Clinical Relapses|Outcomes are presented separately above apart from adverse events which are presented in the adverse event section|up to 5 years|||||||
1280818|NCT00262314|Primary|Clinical Relapses (Annual Follow-Up Phase)|Number of clinical relapses reported during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data|||number of relapses|||Number
1280819|NCT00262314|Primary|Clinical Relapses (Treatment Phase)|Number of clinical relapses reported during the treatment phase of the trial|up to 36 months||||number of relapses|||Number
1280820|NCT00262314|Primary|Severe Neutropenia (Annual Follow-Up Phase)|Number of infections associated with severe neutropenia at onset during the annual follow-up phase|up to 5 years|participants with annual follow up data|||number of infections|||Number
1280821|NCT00262314|Primary|Severe Neutropenia (Treatment Phase)|Number of infections associated with severe neutropenia at onset during the treatment phase|up to 36 months||||number of infections|||Number
1280822|NCT00262314|Primary|IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)|Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase|up to 5 years|participants with annual follow up data|||participants|||Number
1280823|NCT00262314|Primary|IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)|Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase|up to 36 months||||participants|||Number
1280824|NCT00262314|Primary|Serious Infections (Annual Follow-Up Phase)|Number of serious infections during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data|||number of infections|||Number
1280825|NCT00262314|Primary|Serious Infections (Treatment Phase)|Number of serious infections during the treatment phase of the trial|up to 36 months||||number of infections|||Number
1280826|NCT00262314|Primary|Left Ventricular Ejection Fraction (Annual Follow-Up Phase)|Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data|||participants|||Number
1280827|NCT00262314|Primary|Left Ventricular Ejection Fraction (Treatment Phase)|Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial|up to 36 months||||participants|||Number
1280828|NCT00262314|Primary|Congestive Heart Failure (Annual Follow-Up Phase)|Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data|||participants|||Number
1280829|NCT00262314|Primary|Congestive Heart Failure (Treatment Phase)|Number of patients experiencing congestive heart failure during the treatment phase of the trial|up to 36 months||||participants|||Number
1280830|NCT00262301|Secondary|Time to Minimal Symptoms|"the time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale (VAS) score. Symptoms were said to be minimal when the VAS score at all locations was below 20 mm. Assessment time-points were: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to minimal symptoms has been calculated by using the exact time-points on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of study drug administration."|||minutes||Full Range|Median
1280831|NCT00262301|Primary|Time to Beginning of Relief of Symptoms|"The time to beginning of relief of symptoms has been assessed by using a patient-reported visual analogue scale (VAS) ranging from 0 mm (no symptoms at all) to 100 mm (extremely disabling). Time to beginning of relief of symptoms at the location that showed first VAS score decrease of at least 20 mm from baseline score (t= 0 min) to the next assessment time-point). Assessment time-points were taken on pre-scheduled time-points after drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to beginning of relief has been calculated as median time, by using the exact time-points on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."|||minutes||Full Range|Median
1280832|NCT00262223|Secondary|Global Psychiatric Severity||1 year|||||||
1280833|NCT00262223|Secondary|Retention Rates in Alcohol Treatment||1 year|||||||
1280834|NCT00262223|Secondary|Trajectory and Trends of Changes in Substance Use and PTSD Symptoms||1 year|||||||
1280835|NCT00262223|Secondary|Alcohol Subtypes Based on Pre-morbid Risk Factors||1 year|||||||
1280836|NCT00262223|Primary|PTSD Symptom Severity / Clinician Administered PTSD Scale|Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).|Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up||||units on a scale||Standard Deviation|Mean
1280837|NCT00262223|Primary|Heavy Drinking Days/Week||Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up||||Days/Week||Standard Deviation|Mean
1281112|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3|ULN=upper limit of normal; Hb=hemoglobin|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; n=number of participants with measurement|||participants|||Number
1280838|NCT00262119|Primary|Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years|The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.|2 years|Analysis was intention to treat therefore all randomized patients were considered in the analyses|||percentage of participants||95% Confidence Interval|Number
1280839|NCT00262119|Secondary|Frequency, Type, and Associated Cost of Health Care Utilization and Utility||2 years|||||||
1280840|NCT00262119|Secondary|Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients||2 years|||||||
1280841|NCT00262119|Secondary|Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay||2 years|||||||
1280842|NCT00262119|Secondary|Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation||2 years|||||||
1280843|NCT00262119|Secondary|Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism||2 years|||||||
1280844|NCT00262119|Secondary|Development of Atrioventricular (AV) Block and Pacemaker Dependency||2 years|||||||
1280845|NCT00262119|Secondary|Adverse Events||2 years|||||||
1280846|NCT00262119|Secondary|Persistent Atrial Fibrillation (AF)||2 years|||||||
1280847|NCT00262119|Secondary|Atrial Fibrillation Burden||2 years|||||||
1280848|NCT00262119|Secondary|Any Hospitalization||2 years|||||||
1280849|NCT00262119|Secondary|Cardiovascular Death||2 years|||||||
1280850|NCT00262119|Secondary|Cumulative Percentage of Ventricular Pacing||2 years|||||||
1280851|NCT00262119|Secondary|Heart Failure Medications||2 years|||||||
1280852|NCT00262119|Secondary|Subjects' Symptoms||2 years|||||||
1280853|NCT00262119|Secondary|Burden of Composite Clinical Endpoint||2 years|||||||
1280854|NCT00262119|Secondary|Incidence of Cardiovascular Hospitalizations at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years|2 years|Analysis was intention to treat therefore all randomized patients were analysed|||percentage of participants||95% Confidence Interval|Number
1280855|NCT00262119|Secondary|Incidence of Permanent Atrial Fibrillation at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years|2 years|The analysis was intention to treat therefore all randomized patients were analysed|||percentage of participants||95% Confidence Interval|Number
1280856|NCT00262119|Secondary|Death for All Causes at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years|2 years|The analysis was intention to treat therefore all randomized patients were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1280857|NCT00262080|Other Pre-specified|Time to Significant Improvement in Overall Response Over Multiple Treatment Episodes|The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline (ie,immediately before treatment) using the following 5-category scale from significant improvement (Score = 100)to significant worsening (Score = -100)|4 hours post-dose (REPEAT-DOSING PART)|Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the interquartile range (IQR) was not reached by 4 hours for most episodes.|||participants|||Number
1280858|NCT00262080|Secondary|Time to Significant Improvement in Overall Response|"The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline. Patients were asked overall how are you feeling compared to how they felt before study drug. Answer options were a lot worse, a little worse, same, a little better or a lot better or resolved. Significant improvement was the first time that the patient responded to the assessment as a little better or resolved."|4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated. Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the median time for placebo was not reached by 4 hours.|||participant|||Number
1280859|NCT00262080|Other Pre-specified|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose Over Multiple Treatment Episodes|The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose (REPEAT-DOSING PART)|Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention.|||units on a scale||Standard Deviation|Mean
1280860|NCT00262080|Other Pre-specified|Treatment Outcome Score at 4 Hours Post-Dose Over Multiple Treatment Episodes|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100] to significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose (REPEAT-DOSING PART)|Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention.|||units on a scale||Standard Deviation|Mean
1280861|NCT00262080|Other Pre-specified|Number of Patients With Symptom Complexes of Treated Attack at Baseline(DOUBLE-BLIND PART)|Patient-reported severity of symptom complexes at baseline, by symptom complex and treatment group. Patients were to have at least one symptom complex that was moderate or severe. Patients could present with multiple symptom complexes, some of which could be mild. Mild=noticeable but do not impact daily living activities; Moderate=treatment or intervention is highly desirable and activities of daily living are impacted; Severe=require treatment or intervention due to inability to perform activities of daily living. The results are for number of patients with symptom complexes including mild, moderate and severe, provided the patients have at least one symptom complex that was moderate or severe|Baseline||||participants|||Number
1280862|NCT00262080|Secondary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose|Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement (minimally important difference) was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated: two patients randomized on the same day at the same center were administered treatment opposite to their randomized treatment assignments. Data were analyzed based on their actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 0.0; worst possible score = 3.0.|||units on a scale||Standard Deviation|Mean
1280863|NCT00262080|Primary|Treatment Outcome Score at 4 Hours Post-Dose|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100] to significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated: two patients randomized on the same day at the same study center were administered treatment opposite to their randomized treatment assignment. Data were analyzed based on actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 100; worst possible score = -100.|||units on a scale||Standard Deviation|Mean
1280864|NCT00262067|Secondary|Progression-free Survival (PFS) as Determined by the Independent Review Committee Using Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
1280865|NCT00262067|Secondary|1-year Survival|"1-year survival was defined as the percentage of patients who were alive 1 year after randomization.~The percentage of patients alive at 1 year was determined using Kaplan-Meier analyses and the 95% confidence intervals were computed using the Brookmeyer-Crowley method."|Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Percentage of participants||95% Confidence Interval|Number
1280866|NCT00262067|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
1280867|NCT00262067|Secondary|Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from the first tumor assessment that led to a determination of an objective response to the time of disease progression or death due to any cause, whichever occurred first.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients with measurable disease at baseline and who had an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
1280868|NCT00262067|Secondary|Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients with measurable disease at baseline were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1280880|NCT00262028|Secondary|Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|12 months post vaccination (Day 360)|Analysis was done on per protocol population.|||Subjects|||Number
1280962|NCT00261846|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Part 1 Baseline up to Day 28|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1280869|NCT00262067|Primary|Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
1280870|NCT00262041|Secondary|Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination|Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.|Day 1 to Day 7|Analysis was done on safety dataset - subjects who received at least one study dose and had Post baseline safety data.|||Subjects|||Number
1280871|NCT00262041|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.|12 months after vaccination|Analysis was done on PP population.|||Titers||95% Confidence Interval|Geometric Mean
1280872|NCT00262041|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.|12 months after vaccination|Analysis was done on PP population.|||Percentages Of Subjects||95% Confidence Interval|Number
1280873|NCT00262041|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.|1 month after vaccination|Analysis was done on per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1280874|NCT00262041|Primary|Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine|Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y|1 month after vaccination|Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation.|||Percentages Of Subjects||95% Confidence Interval|Number
1280875|NCT00262028|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.|Day 1- Day 360 (Throughout the study)|Analysis was done on safety population.|||Subjects|||Number
1280876|NCT00262028|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.|Day 1- Day 360 (throughout the study)|Analysis was done on safety population.|||Subjects|||Number
1280877|NCT00262028|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.|Day 1 to 7 post vaccination|Analysis was done on safety population.|||Subjects|||Number
1280878|NCT00262028|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.|Day 1 to 7 post vaccination|Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data.|||Subjects|||Number
1280879|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|12 months post vaccination (Day 360)|Analysis was done on per protocol population.|||Titer||95% Confidence Interval|Geometric Mean
1280963|NCT00261833|Other Pre-specified|Baseline Lung Density at Total Lung Capacity (TLC) and Forced Residual Capacity (FRC)||Baseline||||g/L||Standard Deviation|Mean
1280881|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.|||Titer||95% Confidence Interval|Geometric Mean
1280882|NCT00262028|Secondary|hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.|||Titer||95% Confidence Interval|Geometric Mean
1280883|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1280884|NCT00262028|Secondary|Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine|Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1280885|NCT00262028|Secondary|Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine|Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain).|||Percentages of subjects||95% Confidence Interval|Number
1280886|NCT00262028|Primary|Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine|Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.|||Subjects|||Number
1280887|NCT00262002|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age|The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.|7 days after vaccination at 12 months of age|"Analysis was done on safety dataset n population."|||subjects|||Number
1280888|NCT00262002|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-|Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.|7 days after each vaccination|"Analysis was done on safety dataset n population - subjects who received at least one study dose and had Post baseline safety data."|||subjects|||Number
1280889|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)|The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population after second vaccination."|||percentages of subjects||95% Confidence Interval|Number
1280890|NCT00262002|Secondary|ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B|To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||titers||95% Confidence Interval|Geometric Mean
1280891|NCT00262002|Secondary|Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||percentages of subjects||95% Confidence Interval|Number
1280957|NCT00261846|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1|AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.|||ng*hr/mL||Standard Deviation|Mean
1280892|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine|The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.|at 12 months of age and 1 month after PS challenge|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
1280893|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine|The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||percentages of subjects||95% Confidence Interval|Number
1280894|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.|Before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||titers||95% Confidence Interval|Geometric Mean
1280895|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.|Before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
1280896|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.|before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||titers||95% Confidence Interval|Geometric Mean
1280897|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.|before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
1280898|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.|at 12 months of age|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||Titers||95% Confidence Interval|Geometric Mean
1280899|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.|at 12 months of age|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
1280900|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.|The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.|at 12 months of age|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response."|||titers||95% Confidence Interval|Geometric Mean
1280901|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine|The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.|at 12 months of age|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
1280902|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.|at 12 months of age and 1 month after booster vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||titers||95% Confidence Interval|Geometric Mean
1280958|NCT00261846|Primary|Plasma Decay Half-Life (t1/2) - Part 1|"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.~NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||hrs||Standard Deviation|Mean
1280903|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine|Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.|at 12 months of age and 1 month after booster vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
1280904|NCT00262002|Secondary|Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population"|||titers||95% Confidence Interval|Geometric Mean
1280905|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population."|||percentages of subjects||95% Confidence Interval|Number
1280906|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||titers||95% Confidence Interval|Geometric Mean
1280907|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||percentages of subjects||95% Confidence Interval|Number
1280908|NCT00262002|Primary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine|Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.|Baseline and at 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||percentages of subjects||95% Confidence Interval|Number
1280909|NCT00261950|Secondary|Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52||Baseline to week 52|Enrolled subjects with TRAP at week 52|||percent change||Standard Error|Mean
1280910|NCT00261950|Secondary|Percent Change From Baseline in Osteocalcin (OC) at Week 52||Baseline to week 52|Enrolled subjects with osteocalcin (OC) at week 52|||Percent change||Standard Error|Mean
1280911|NCT00261950|Secondary|Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter|"Eroded Perimeter/Bone Perimeter was calculated as Eroded Perimeter/Bone Perimeter * 100"|Baseline to week 52|Enrolled subjects with eroded perimeter/bone perimeter at week 52|||percentage of bone perimeter||Standard Error|Mean
1280912|NCT00261950|Secondary|Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area|Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100)|Baseline to week 52|Enrolled subjects with Fibrosis Area/Tissue Area at week 52|||participants|||Number
1280913|NCT00261950|Secondary|Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)|"Osteoclast Perimeter was calculated as Osteoclast Perimeter/Eroded Perimeter * 100"|Baseline to week 52|Enrolled subjects with Osteoclast Perimeter at week 52|||percentage of eroded perimeter||Standard Error|Mean
1280914|NCT00261950|Secondary|Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)|"Osteoblast Perimeter was calculated as Osteoblast Perimeter/Osteoid Perimeter * 100"|Baseline to week 52|Enrolled subjects with Osteoblast Perimeter at week 52|||percentage of osteoid perimeter||Standard Error|Mean
1280915|NCT00261950|Primary|Change From Baseline to End of Study in Bone Formation Rate (BFR)||Baseline to week 52|Enrolled subjects with bone biopsy at week 52|||μm^2/mm^2/day||Standard Error|Mean
1280916|NCT00261950|Secondary|Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with PTH during the Efficacy Assessment Phase (EAP)|||percent change||Standard Error|Mean
1280917|NCT00261950|Secondary|Percent Change From Baseline in N – Telopeptide (NTx) at Week 52||Baseline to week 52|Enrolled subjects with NTx at week 52|||percent change||Standard Error|Mean
1280918|NCT00261950|Secondary|Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52||Baseline to week 52|Enrolled subjects with BALP at week 52|||percent change||Standard Error|Mean
1280919|NCT00261950|Secondary|Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with Ca x P during the Efficacy Assessment Phase (EAP)|||percent change||Standard Error|Mean
1280920|NCT00261950|Secondary|Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with serum phosphorus during the Efficacy Assessment Phase (EAP)|||percent change||Standard Error|Mean
1280921|NCT00261950|Secondary|Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with serum calcium during the Efficacy Assessment Phase (EAP)|||percent change||Standard Error|Mean
1281912|NCT00250679|Primary|Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations|"Percent of participants with the adverse event specified.~SOC = system organ class."|Six months|ITT Population|||percent of participants|||Number
1280922|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values|Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per min and value >150 beats per min, SBP of <80 or >210 mmHg, DBP of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, Resp of <10 or >50 breaths/min and criteria for PCI change in physical examination: >=10% increase or decrease of body weight in kg. No Ph+ ALL participants were analyzed post-therapy (N=0). Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.|Post-therapy|Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. PLEASE NOTE: Results were not applicable for Arms in Part 1 since all participants in Part 1 entered Part 2 and continued the study treatment.|||percentage of participants|||Number
1280923|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs|Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per min and value >150 beats per min, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, respiratory rate (Resp) of <10 or >50 breaths/min and criteria for PCI change in physical examination: >=10% increase or decrease of body weight in kilogram (kg).|Screening, Baseline, and end of treatment|Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||percentage of participants|||Number
1280924|NCT00261846|Secondary|Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)|ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work;2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities;3=capable of only limited self care, confined to bed/chair >50% of waking hrs;4=completely disabled, cannot carry on any self care, totally confined to bed/chair;5=dead.|Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter|Safety population included all participants who receive at least one dose of study medication.|||participants|||Number
1280925|NCT00261846|Secondary|Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE are reported.|Baseline and Weeks 1, 2, 3, 4, 8, 12, then every 12 weeks thereafter until end of treatment, for a mean duration of 28 months|Safety population included all participants who receive at least one dose of study medication.|||participants|||Number
1280926|NCT00261846|Secondary|Number of Participants With Change From Baseline in Findings of Chest X-ray|Number of participants whose chest X-ray results changed (worsened or improved) from the Baseline.|Baseline, Week 8, and end of treatment|Safety population included all participants who received at lease one dose of study medication.|||participants|||Number
1280927|NCT00261846|Secondary|Percentage of Participants With On-treatment PCI Change From Baseline in Electrocardiogram (ECG) Findings|Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval >=220 msec and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett formula (QTcB) >500 msec or increase of >60 msec; heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit|Safety population included all participants who receive at least one dose of study medication. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure.|||Percentage of participants|||Number
1280928|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Laboratory Tests Results|Laboratory assessments included urinalysis, complete blood count (CBC), prothrombin time/partial prothromboplastin time (PT/PPT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Parameters of special interest included liver function tests and those related to myelosuppression. Potentially clinically important (PCI) laboratory values were defined as National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. Maximum CTCAE grade, and only participants who shifted to Grade 3/4 on-treatment, are reported.|Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter|Safety population included all participants who receive at least one dose of study medication.|||Percentage of Participants|||Number
1280929|NCT00261846|Secondary|Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)|"An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. The event did not necessarily have a causal relationship with the treatment. PCI AEs included anemia, alanine aminotranferase (ALT), aspartate aminotransferase (AST), cardiac, diarrhea, edema, effusion, gastrointestinal, hemorrhage, hypersensitivity, hypertension, infection, liver, myelosuppression, nausea, neutropenia, rash, renal, thrombocytopenia, vomiting, and vascular events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates.~NA = not estimable."|Baseline up to follow-up visit (30 days after last dose of study treatment)|Safety population included all participants who receive at least one dose of study medication.|||days||Full Range|Median
1280930|NCT00261846|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to follow up visit (30 days after last dose of study treatment)|Safety population included all participants who receive at least one dose of study medication.|||percentage of participants|||Number
1280931|NCT00261846|Secondary|Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2|OHR included CHR, no evidence of leukemia (≤5% bone marrow blasts, no peripheral blood blasts or promyelocytes, <5% myelocytes + metamyelocytes in blood, white blood cells ≤ institutional upper limit of normal, 450x10^9/L > platelets > 20x10^9/L, absolute neutrophil count ≥0.5x10^9/L, <20% basophils in blood, no extramedullary involvement [including liver or spleen]), minor hematologic response (acute lymphoblastic leukemia [ALL] patients only, defined as <15% blasts in marrow & blood, <30% blasts + promyelocytes in marrow & blood, <20% basophils in peripheral blood & no extramedullary disease other than spleen & liver) or return to chronic phase (AP/BP participants, defined as <15% blasts in both peripheral blood &bone marrow, <30% blasts + promyelocytes in both peripheral blood & bone marrow, <20% basophils in both peripheral blood & bone marrow, no extramedullary Involvement other than liver or spleen). Participants had to meet at least 1 criterion.|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 1 year|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.|||percentage of participants||95% Confidence Interval|Number
1280932|NCT00261846|Secondary|Percentage of Participants With Confirmed Complete Hematologic Response (CHR) - Part 2|Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells ≤ institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count ≥ 1.0×10^9/L , platelets <450×10^9/L, platelets ≥100×10^9/L, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed).|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.|||percentage of participants||95% Confidence Interval|Number
1280933|NCT00261846|Secondary|Overall Survival (OS) - Part 2|"OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored.~NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least 1 dose of study medication.|||Months||95% Confidence Interval|Median
1280934|NCT00261846|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) - Part 2|"OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored.~NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1280935|NCT00261846|Secondary|Progression Free Survival (PFS) - Part 2|"PFS was based on Kaplan-Meier method. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4.~NA = not estimable. One year = 12 months"|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least one dose of study medication.|||Months||95% Confidence Interval|Median
1280936|NCT00261846|Secondary|Cumulative Incidence of Progression/Death - Part 2|"The cumulative incidence of on-treatment progression or death adjusting for the competing risk of treatment discontinuation without the event. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4. 95% confidence intervals were calculated using Gray’s method.~NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1280937|NCT00261846|Secondary|Time to Achieve Complete Hematologic Response (CHR) for Responders Only - Part 2|The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response for responders only.|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment - responders only.|||weeks||95% Confidence Interval|Median
1280938|NCT00261846|Secondary|Duration of Complete Hematologic Response (CHR) - Part 2|"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes less than (<)5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10^9 per liter (/L) , platelets <450×10^9/L, platelets ≥100×10^9/L, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7.~NA = not estimable."|From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Subgroup of participants from evaluable population who had confirmed CHR.|||weeks||95% Confidence Interval|Median
1280959|NCT00261846|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1||0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline efficacy assessment.|||hours (hrs)||Full Range|Median
1280960|NCT00261846|Primary|Maximum Observed Plasma Concentration (Cmax) - Part 1||0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1280939|NCT00261846|Secondary|Kaplan-Meier Estimate of Maintaining Complete Hematologic Response (CHR) at Year 4 (CP3L and ADV) or Year 5 (CP2L) - Part 2|"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10^9 per liter (/L) , platelets ≥100×10^9/L & <450×10^9/L, <20% basophils in blood & no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (ADV only & applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. The Kaplan-Meier estimate of maintaining CHR at the end of minimum follow-up is presented (CP2L: Year 5; CP3L & ADV: Year 4). NA = not estimable.~NA = not estimable."|From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Subgroup of participants from evaluable population who had confirmed CHR.|||% estimate of maintaining response||95% Confidence Interval|Number
1280940|NCT00261846|Secondary|Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML for Responders Only - Part 2|"MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.~Time to response in weeks equals (=) (event date minus (-) first dose date plus (+) 1)divided (/)7, where the event date is the non-missing date of the first attained response for responders only."|Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 5|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.|||weeks||95% Confidence Interval|Median
1280941|NCT00261846|Secondary|Kaplan-Meier Estimate of Retaining an Attained/Maintained Major Cytogenetic Response (MCyR) at Year 5 in Chronic Phase Second-line CML - Part 2|MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. The Kaplan-Meier probability of retaining an attained/maintained MCyR at Year 5 is reported. Median durations were not reached as of the minimum follow-up. Duration of response in weeks =(date of confirmed loss of first attained response or last valid cytogenetic assessment for those censored - date of first attained response)/7.|From first MCyR to loss of MCyR or censoring, assessed every 12 weeks up to 2 years and then every 24 weeks thereafter up to Year 5|Subgroup of participants from evaluable population who had MCyR.|||% probability of retaining MCyR||95% Confidence Interval|Number
1280942|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Chronic Phase Third-line CML Population - Part 2|CyR is based on the prevalence of Ph+ cells. MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.|Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L) or Year 5 (CP2L)|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.|||percentage of participants||95% Confidence Interval|Number
1280943|NCT00261846|Secondary|Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1|"CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the CD3+ (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using FACS flow cytometry.~NA = not estimable."|6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' signifies number of participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time points for each arm group respectively.|||percent change||Standard Deviation|Mean
1280944|NCT00261846|Secondary|Phosphorylation Inhibition of Crk Like (CrkL) Protein at Baseline - Part 1|CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the cluster of differentiation 3 (CD3+) (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using fluorescent activated cell sorter (FACS) flow cytometry.|0 (pre-dose) on Day 1 (Baseline)|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||mol/100 cells||Standard Deviation|Mean
1280945|NCT00261846|Secondary|Phosphorylation Inhibition of Breakpoint Cluster Region-Abelson Kinase (Bcr-Abl) - Part 1|bcr-Abl is a protein resulting from the transcription of the Philadelphia chromosome following 9:22 chromosomal translocation, and phosphorylation inhibition of which correlates with inhibition of tumor cell growth.|Baseline, Weeks 4, 8, 12, 24, 36, 48 and the end of the active treatment phase of Part 1 (Week 52)|Data was not summarized since inadequate data included the issue that molecular transcript analyses could not be performed, because of potential sample quality issues due to time required to transport the specimens from the few investigational sites to the central laboratory.||||||
1280961|NCT00261846|Primary|Maximum Tolerated Dose (MTD)|"MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).~NA = not estimable."|Part 1 Baseline up to Day 28|Safety population included all participants who received at least 1 dose of study medication|||mg|||Number
1280946|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.|Weeks 12, 24, 36, 48 and the end of active treatment phase of Part 1 (Week 52)|Cytogenetic evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline cytogenetic assessment.|||percentage of participants||95% Confidence Interval|Number
1280947|NCT00261846|Primary|Percentage of Participants With MCyR at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2|CyR is based on the prevalence of Ph+ cells. Major cytogenetic response was categorized as either CCyR or partial CyR (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or less than (<) 1% positive cells from at least 200 cells analyzed from fluorescent in situ hybridization (FISH). PCyR was achieved when 1 to 35% Ph+ cells were present.|Week 24|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.|||percentage of participants||95% Confidence Interval|Number
1280948|NCT00261846|Primary|Accumulation Ratio (R)|R=accumulation ratio (AUCss on Day 15/AUC0-24 on Day 1)|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1280949|NCT00261846|Primary|Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent oral clearence over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||L/hr||Standard Deviation|Mean
1280950|NCT00261846|Primary|Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
1280951|NCT00261846|Primary|Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||hrs||Standard Deviation|Mean
1280952|NCT00261846|Primary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1|Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.|||hrs||Full Range|Median
1280953|NCT00261846|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1|Maximum plasma concentration over 24 hours at steady state (ss), on Day 15.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1280954|NCT00261846|Primary|Apparent Volume of Distribution (Vz/F) - Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||liter||Standard Deviation|Mean
1280955|NCT00261846|Primary|Apparent Oral Clearance (CL/F) - Part 1|"Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.~NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||liter per hour (L/hr)||Standard Deviation|Mean
1280956|NCT00261846|Primary|Area Under the Concentration-Time Curve (AUC) - Part 1|"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.~NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
1280964|NCT00261833|Secondary|Severity of Pulmonary Exacerbations|"Defined as the number of participants requiring 1) antibiotic treatment for exacerbations, and 2) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.~Antibiotic treatment usage was reported by quarterly interval."|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.|||participants|||Number
1280965|NCT00261833|Secondary|Duration of Pulmonary Exacerbations Relative to Treatment Duration|Defined as the percentage of total treatment duration across participants for 1) exacerbations overall, 2) antibiotic treatment for exacerbations, and 3) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.|||percentage of total treatment duration||Standard Deviation|Mean
1280966|NCT00261833|Secondary|Percent Change in DLCO|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||percent change||Standard Error|Least Squares Mean
1280967|NCT00261833|Secondary|Percent Change in FEV1 Divided by Forced Vital Capacity|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||percent change||Standard Error|Least Squares Mean
1280968|NCT00261833|Secondary|Percent Change in Percent Predicted FEV1|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||percent change||Standard Error|Least Squares Mean
1280969|NCT00261833|Secondary|Frequency and Intensity of Adverse Events (AEs)|Number of participants with at least one AE, and the number of participants with mild, moderate or severe AEs. AE intensity was defined as mild (does not interfere with routine activities), moderate (interferes with routine activities), or severe (impossible to perform routine activities).|Over a 2-year period|All participants receiving at least 1 infusion of either Zemaira® or placebo.|||participants|||Number
1280970|NCT00261833|Secondary|Change in Patient-reported Symptoms|Patient-reported symptoms were measured using the symptoms score component of the St George's Respiratory Questionnaire (SGRQ). SGRQ scores range from 0 to 100, with higher scores indicating more limitations and negative values for change indicating improvement. Change from baseline to end of treatment (2 years) in SGRQ was analysed using an ANCOVA.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||units on a scale||Standard Error|Least Squares Mean
1280971|NCT00261833|Secondary|Change in Exercise Capacity|Exercise capacity was measured as distance walked, using the incremental shuttle walk test. Change from baseline to end of treatment (2 years) in exercise capacity was analysed using an analysis of covariance (ANCOVA).|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||metre||Standard Error|Least Squares Mean
1280972|NCT00261833|Secondary|Change in Lung Density|Change from baseline to Month 24 as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least 1 endpoint assessment available.|||g/L||Standard Error|Least Squares Mean
1280973|NCT00261833|Secondary|Time to First Pulmonary Exacerbation|Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.|||Years||95% Confidence Interval|Median
1280974|NCT00261833|Secondary|Percent Change in FEV1|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||percent change||Standard Error|Least Squares Mean
1280975|NCT00261833|Secondary|Annual Rate of Pulmonary Exacerbations|Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion. The annual rate was based on the total number of exacerbations and the total number of participant study days for all participants in the specified analysis population and adjusted to 365.25 days.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.|||exacerbations per participant year||95% Confidence Interval|Number
1280976|NCT00261833|Primary|Annual Rate of Change in Lung Density|As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in each treatment group.|Over a 2-year period|All randomized participants with at least 1 valid CT scan.|||g/L per year||Standard Error|Least Squares Mean
1280992|NCT00261495|Secondary|Number of Drop-outs|Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52.|baseline to week 24 (core); week 24 to week 52 (extension)|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1280977|NCT00261716|Secondary|Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)|Employment status at each major follow-up assessment period and overall adjustment as rated on the Social Adjustment Scale II (Schooler, N., G. Hogarty, and M. Weissman, Social Adjustment Scale II (SAS-II), in Resource Materials for Community Mental Health Program Evaluations, W.A. Hargreaves, C.C. Atkisson, and J.E. Sorenson, Editors. 1979, NIMH: Rockville, MD. p. 290-303), on a 1 (excellent adjustment ) to 7 (severe maladjustment) scale.|6, 12, and 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=25 analyzed at 6 months; total n= 16 analyzed at 12 months; total n = 17 analyzed at 18 months|||units on a scale||Standard Deviation|Mean
1280978|NCT00261716|Secondary|Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)|Employment status at each major follow-up assessment period and self-reported Life Satisfaction (range from 1 (terrible) to 7 (delighted)) on the Quality of Life Scale (Lehman A, Kernan E, and Postrado L, Toolkit for Evaluating Quality of Life for Persons with Severe Mental Illness. 1995, Baltimore, MD: The Evaluation Center at HSRI).|6,12, 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=26 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 17 analyzed at 18 months|||units on a scale||Standard Deviation|Mean
1280979|NCT00261716|Secondary|Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale|Employment status at each major follow-up assessment period and psychiatric symptomatology as reflected in the Total Brief Psychiatric Rating Scale Score (Ventura J, et al., Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Research, 1998. 79(2): p. 163-173) with scale range from 24 to 168, with higher scores indicating greater symptomatology|6,12, 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=23 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 16 analyzed at 18 months|||units on a scale||Standard Deviation|Mean
1280980|NCT00261716|Secondary|Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program|Number of participants who obtained a second or third job if lost his/her first job but still had at least 2 months in the study|18 months of the study|Includes only participants who obtained at least one job and had at least 2 months left if they lost/left that job; 2 individuals in each condition held the same job for almost the whole program and thus could not contribute data here|||participants|||Number
1280981|NCT00261716|Primary|Average Number of Hours Worked Per Week For Those Who Worked|Average number of hours worked per week among participants who obtained a job|18 months of study|Only included hours worked for participants who obtained a job (n=19 in the entire study)|||hours/worked per week||Standard Deviation|Mean
1280982|NCT00261716|Primary|Average Number of Days Worked|Average number of total days each participant worked in the study|18 months of study||||days||Standard Deviation|Mean
1280983|NCT00261716|Primary|Obtained Employment|Number of participants who obtained a competitive job|18 months of study||||participants|||Number
1280984|NCT00261495|Primary|Equi-analgesic Dose at Steady State (ITT Population)|Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.|week 4 to week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||mg per day||Standard Deviation|Mean
1280985|NCT00261495|Primary|Equi-analgesic Dose at Steady-state (PP Population)|Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.|week 4 to week 24|PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)|||mg per day||Standard Deviation|Mean
1280986|NCT00261495|Primary|Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)|If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||mg per day||Standard Deviation|Mean
1280987|NCT00261495|Primary|Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)|If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.|week 24|PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)|||mg per day||Standard Deviation|Mean
1280988|NCT00261495|Secondary|Resource Utilization of Pain Management|Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Additional visits||Standard Deviation|Mean
1280989|NCT00261495|Secondary|Mode and Convenience of Drug Intake.|Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1280990|NCT00261495|Secondary|Amount of add-on Pain Medication|Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24.|24 weeks|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||mg||Standard Deviation|Mean
1280991|NCT00261495|Secondary|Number of Days With add-on Pain Medication|Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Days||Standard Deviation|Mean
1280993|NCT00261495|Secondary|Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)|Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24.|weeks 4 and 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1280994|NCT00261495|Secondary|Change in Dose of Study Treatment|Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1280995|NCT00261495|Secondary|Clinical Global Assessment of Efficacy|Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1280996|NCT00261495|Secondary|Change From Baseline in QoL at Week 52|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1280997|NCT00261495|Secondary|"Change From Baseline in QoL Vitality at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1280998|NCT00261495|Secondary|"Change From Baseline in QoL Social Functioning at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1280999|NCT00261495|Secondary|"Change From Baseline in QoL Role Physical at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281000|NCT00261495|Secondary|"Change From Baseline in QoL Role Emotional at Week 24"|"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281001|NCT00261495|Secondary|"Change From Baseline in QoL Physical Functioning at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281002|NCT00261495|Secondary|"Change From Baseline in QoL Mental Health at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281003|NCT00261495|Secondary|"Change From Baseline in QoL Health Transition at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281004|NCT00261495|Secondary|"Change From Baseline in QoL General Health Perceptions at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281005|NCT00261495|Secondary|"Change From Baseline in QoL Bodily Pain at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281019|NCT00261495|Secondary|Number of Subjects Indicating Optimal Sleep at Week 52|Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night.|week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1281006|NCT00261495|Secondary|"Change From Baseline in QoL Vitality at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281007|NCT00261495|Secondary|"Change From Baseline in QoL Social Functioning at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281008|NCT00261495|Secondary|"Change From Baseline in QoL Role Physical at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281009|NCT00261495|Secondary|"Change From Baseline in QoL Role Emotional at Week 4"|"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281010|NCT00261495|Secondary|"Change From Baseline in QoL Physical Functioning at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281011|NCT00261495|Secondary|"Change From Baseline in QoL Mental Health at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281012|NCT00261495|Secondary|"Change From Baseline in QoL Health Transition at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281013|NCT00261495|Secondary|"Change From Baseline in QoL General Health Perceptions at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281014|NCT00261495|Secondary|"Change From Baseline in Quality of Life (QoL) Bodily Pain at Week 4"|Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281015|NCT00261495|Secondary|Number of Subjects With Dose Escalation at Week 24 (ITT Population)|The number of subjects with dose increase in study medication was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1281016|NCT00261495|Secondary|Number of Subjects With Dose Escalation at Week 4 (ITT Population)|The number of subjects with dose increase in study medication was assessed at week 4.|week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1281017|NCT00261495|Secondary|"Change From Baseline in Subject Diary Mean Pain Score for Pain at Its Worst From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24"|"Change from baseline in subject diary mean pain score pain at its worst from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score pain at its worst."|baseline and weeks 4, 8, 12, 16, 20, and 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281018|NCT00261495|Secondary|Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24|Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281020|NCT00261495|Secondary|Change From Baseline in Sleep Quality at Week 52|Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281021|NCT00261495|Secondary|Number of Subjects Indicating That They Had Optimal Sleep at Week 24|Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1281022|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Quantity at Week 24|Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281023|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24|Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281024|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24|Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281025|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24|Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281026|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Snoring at Week 24|Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281027|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24|Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281028|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index II) at Week 24|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281029|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index II) at Week 4|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281030|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index I) at Week 4|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281041|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 4"|"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281031|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)|Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281032|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281033|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281034|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281035|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281036|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281037|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281038|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With General Activity (BPI Item 9a) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281039|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281040|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 4"|"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281087|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
1281042|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281043|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281044|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281045|NCT00261495|Secondary|"Change From Baseline in BPI Interference Score Interfered With General Activity (BPI Item 9a) at Week 4"|"Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281046|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24|Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281047|NCT00261495|Secondary|Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24|Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281048|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 24"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281049|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Pain at Its Least (BPI Item 4) at Week 24"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281050|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4|Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281051|NCT00261495|Secondary|Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4|Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281052|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281106|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
1281053|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Pain at Its Worst (BPI Item 3) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its worst (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281054|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Score Pain at Its Least (BPI Item 4) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281055|NCT00261495|Secondary|"Change From Baseline in BPI Severity Score Pain Right Now (BPI Item 6) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain right now (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281056|NCT00261495|Secondary|Number of Subjects With Dose Escalation|Number of subjects with dose increase in study medication.|week 4 and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
1281057|NCT00261495|Secondary|"Change From Baseline in Subject Diary Morning Mean Pain Score Pain Right Now at Week 24"|"Change from baseline to week 24 in subject diary morning mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281058|NCT00261495|Secondary|"Change From Baseline in Subject Diary Evening Mean Pain Score Pain Right Now at Week 24"|"Change from baseline to week 24 in subject diary evening mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281059|NCT00261495|Secondary|Change From Baseline in Sleep Quality at Week 24|Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281060|NCT00261495|Primary|"Change From Baseline in BPI Questionnaire Item 6 Pain Right Now Score at Week 24 (Intent to Treat [ITT] Population)"|"Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281061|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Sub-score Pain at Its Worst (BPI Item 3) at Week 24 (ITT Population)"|"Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
1281062|NCT00261495|Primary|"Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 Pain Right Now Score at Week 24 (Per Protocol [PP] Population)"|"Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 24|PP population (all randomized subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)|||Units on a scale||Standard Deviation|Mean
1281063|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities|ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--> present post-baseline.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with ECG evaluation|||Participants|||Number
1281107|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1281108|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1281064|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities|Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with laboratory evaluation|||Participants|||Number
1281065|NCT00261443|Secondary|Extension Phase: Adverse Events (AEs), by Maximum Intensity|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with AEs|||Participants|||Number
1281066|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities|Vital sign abnormalities considered by the investigator as clinically relevant.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Extension Phase Safety Sample|||Participants|||Number
1281067|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase|Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.)|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of Participants Analyzed=Participants in Extension Phase Safety Sample; n=number of participants with evaluation|||Participants|||Number
1281068|NCT00261443|Secondary|Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Extension Phase Safety Sample|||Participants|||Number
1281069|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
1281070|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point|||units on a scale||Standard Error|Mean
1281071|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point|||units on a scale||Standard Error|Mean
1281072|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
1281073|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
1281074|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 of LTE Phase. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point|||units on a scale||Standard Error|Mean
1281075|NCT00261443|Secondary|Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3||Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample|||participants|||Number
1281076|NCT00261443|Secondary|Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281077|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281078|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281079|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281080|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281081|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||bpm||Full Range|Median
1281082|NCT00261443|Secondary|Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement.|Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281083|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
1281084|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
1281085|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
1281086|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
1281088|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3|Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample|||Participants|||Number
1281089|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)|Phase 3 Safety Sample, participants with measurement|||x 10^3 c/uL||Full Range|Median
1281090|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1281091|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1281092|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1281093|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||ng/mL||Full Range|Median
1281094|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)|Phase 3 Safety Sample, participants with measurement|||x10^9 c/L||Full Range|Median
1281095|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||percent of total white blood cell count||Full Range|Median
1281096|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1281097|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
1281098|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value|Phase 3 Safety Sample, participants with measurement|||proportion of 'normal function'||Full Range|Median
1281099|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value|Phase 3 Safety Sample, participants with measurement|||percentage of 'normal function'||Full Range|Median
1281100|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1281101|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)|Phase 3 Safety Sample, participants with measurement|||percentage of total blood volume||Full Range|Median
1281102|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)|Phase 3 Safety Sample, participants with measurement|||g/dL||Full Range|Median
1281103|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1281104|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample|The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count).|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||percent of total white blood cell count||Full Range|Median
1281105|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
1288260|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1|Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1|Month 1||||L||Standard Error|Mean
1281114|NCT00261443|Secondary|Number of Participants Showing Relevant Weight Loss During Phase 3|Relevant weight loss: >=7% decrease from baseline|Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)|Phase 3 Safety Sample; n=number of participants with measurement at time point|||Participants|||Number
1281115|NCT00261443|Secondary|Number of Participants Showing Relevant Weight Gain During Phase 3|Relevant weight gain: >=7% increase from baseline|Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)|Phase 3 Safety Sample; n=number of participants with measurement at time point|||Participants|||Number
1281116|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in Weight||Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value)|Observed Cases Data Set, Week 52 LOCF; n= number of participants with value at time point|||kg||Standard Error|Mean
1281117|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||beats per minute||Full Range|Median
1281118|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||mm Hg||Full Range|Median
1281119|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||mm Hg||Full Range|Median
1281120|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||beats per minute ?||Full Range|Median
1281121|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||mm Hg||Full Range|Median
1281122|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||mm Hg||Full Range|Median
1281123|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)|||beats per minute (bpm)||Full Range|Median
1281124|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)|||mm Hg||Full Range|Median
1281125|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)|||mm Hg||Full Range|Median
1281126|NCT00261443|Secondary|Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3|Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; n= number of participants with measurement|||Participants|||Number
1281127|NCT00261443|Secondary|Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; (n=number of participants in sample for each category)|||Participants|||Number
1281128|NCT00261443|Secondary|Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample|||Participants|||Number
1281129|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281158|NCT00261443|Secondary|Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.|||mmHg||Full Range|Median
1281130|NCT00261443|Secondary|Baseline in Barnes Akathisia Global Clinical Assessment|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281131|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281132|NCT00261443|Secondary|Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281133|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281134|NCT00261443|Secondary|Baseline Abnormal Involuntary Movement Scale (AIMS)|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline|Phase 2 Safety Sample, participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281135|NCT00261443|Secondary|Median Change From Baseline in Leukocytes at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||x10^3 c/L||Full Range|Median
1281136|NCT00261443|Secondary|Median Baseline Leukocytes||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||x10^3 c/L||Full Range|Median
1281137|NCT00261443|Secondary|Median Change From Baseline in Prolactin at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||ng/dL||Full Range|Median
1281138|NCT00261443|Secondary|Median Baseline Prolactin||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||ng/dL||Full Range|Median
1281139|NCT00261443|Secondary|Median Change From Baseline in Platelet Count at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||x10^9 c/L||Full Range|Median
1281140|NCT00261443|Secondary|Median Baseline Platelet Count||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||x10^9 c/L||Full Range|Median
1281141|NCT00261443|Secondary|Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||proportion of 'normal function'||Full Range|Median
1281159|NCT00261443|Secondary|Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.|||beats per minute||Full Range|Median
1288261|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1|Estimated FEV1 before bronchodilator at Month 1|Month 1||||L||Standard Error|Mean
1281142|NCT00261443|Secondary|Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||percentage of 'normal function'||Full Range|Median
1281143|NCT00261443|Secondary|Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||proportion of 'normal function'||Full Range|Median
1281144|NCT00261443|Secondary|Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||percentage of 'normal function'||Full Range|Median
1281145|NCT00261443|Secondary|Median Change From Baseline in Hematocrit||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||percentage of total blood volume||Full Range|Median
1281146|NCT00261443|Secondary|Median Baseline Hematocrit||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||percentage of total blood volume||Full Range|Median
1281147|NCT00261443|Secondary|Median Change From Baseline in Hemoglobin||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||g/dL||Full Range|Median
1281148|NCT00261443|Secondary|Median Baseline Hemoglobin||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||g/dL||Full Range|Median
1281149|NCT00261443|Secondary|Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||percent of total white blood cell count||Full Range|Median
1281150|NCT00261443|Secondary|Median Baseline Eosinophils (Relative) and Neutrophils (Relative)||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||percent of total white blood cell count||Full Range|Median
1281151|NCT00261443|Secondary|Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||U/L||Full Range|Median
1281152|NCT00261443|Secondary|Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||U/L||Full Range|Median
1281153|NCT00261443|Secondary|Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.|||msecs||Full Range|Median
1281154|NCT00261443|Secondary|Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||U/L||Full Range|Median
1281155|NCT00261443|Secondary|Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||U/L||Full Range|Median
1281156|NCT00261443|Secondary|Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with measurement at time point.|||kg/m^2||Full Range|Median
1281157|NCT00261443|Secondary|Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with measurement at time point.|||kg||Full Range|Median
1281160|NCT00261443|Secondary|Median Baseline and Change From Baseline in ECG Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.|||msecs||Full Range|Median
1281161|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2|ULN=upper limit of normal; HDL=high density lipoprotein; LDL=low density lipoprotein. Values for ULN are provided by the lab in the database and could be different for each individual patient based on characteristics such as age, gender, or other patient attributes.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||Participants|||Number
1281162|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2|Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample|||Participants|||Number
1281163|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2|Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample|||Participants|||Number
1281164|NCT00261443|Secondary|Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|During Phase 2. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample|||Participants|||Number
1281165|NCT00261443|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|During Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample|||Participants|||Number
1281166|NCT00261443|Secondary|Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)||Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Randomized Sample|||Proportion of Participants|||Number
1281167|NCT00261443|Secondary|Number of Participants Maintaining Remission During Phase 3|Remission is defined as Y-MRS Total Score <=12 and MADRS Total Score <=12.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Observed cases data set, Phase 3 Efficacy Sample|||participants|||Number
1281168|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
1281169|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281170|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
1281171|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281172|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
1281173|NCT00261443|Secondary|Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281174|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281175|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
1281176|NCT00261443|Secondary|Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281177|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
1281178|NCT00261443|Secondary|Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281179|NCT00261443|Secondary|Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; N=number of participants evaluated at time point; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
1281180|NCT00261443|Secondary|Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
1281181|NCT00261443|Secondary|Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3|The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the “best” rating and 4 or 8 is the “worst” rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst).|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; n=number of participants with measurement at time point|||units on a scale||Standard Error|Mean
1281182|NCT00261443|Secondary|Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2|"The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. Seven items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst)."|Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; n=number of participants with measurement at given time point.|||units on a scale||Standard Error|Mean
1281183|NCT00261443|Secondary|Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3|Kaplan Meier estimated survival rate. Relapse is defined as any of the following events accompanied by a YMRS > 16 and/or a MADRS > 16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score > 16.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3|Randomized sample, n=number of participants at risk at given time point|||proportion of participants|||Number
1281184|NCT00261443|Secondary|Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3|Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: relapse is defined as any of the following events accompanied by a Young-Mania Rating Scale (Y-MRS) >16 and/or a Montgomery Åsberg Depression Rating Scale (MADRS) >16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score >16.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3|Randomized sample, n=number of participants at risk at given time point|||proportion of participants|||Number
1281185|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|LOCF data set, phase 3 efficacy sample; n=number of participants evaluated at given time point|||units on a scale||Standard Error|Mean
1281186|NCT00261443|Primary|Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3|Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS > 16 and/or a MADRS > 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS > 16 and/or a MADRS > 16.|Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Randomized Sample; n=number of participants at risk at each time point|||proportion of participants|||Number
1281187|NCT00260962|Secondary|Obsessions|Obsessions subscale of the Yale-Brown Obsessive Compulsive Scale. Minimum score is 0 and maximum score is 20. Higher scores indicate higher levels of obsessions.|Pretreatment (Week 1) and Posttreatment (Week 13)||||units on a scale||Standard Deviation|Mean
1281188|NCT00260962|Primary|Body Mass Index (BMI) (kg/m^2)|Body Mass Index (BMI) measured in kg/m^2 units. Measured at Baseline (week 2) and post-treatment (week 13).|Baseline (week 2) and post-treatment (week 13)|4 participants discontinued in placebo group and 2 did not have weight measurements at week 13. 2 participants discontinued in the olanzapine group|||kg/m^2||Standard Deviation|Mean
1281189|NCT00260832|Secondary|Comparison of Complete Remission Rates Between Arm A and Arm B|Morphologic complete remission (CR) plus CR without platelet recovery (CRp) rate|Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available. No stated duration of response required for complete remission classification|||||||
1281971|NCT00249795|Secondary|Death From Any Cause|The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
1281190|NCT00260832|Primary|Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.|The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.|The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.|The primary population for all efficacy analyses was the Intent-to-treat (ITT) population defined as all subjects randomly allocated to a treatment arm.|||months||Full Range|Median
1281191|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)~Absolute neutrophil count > 500/ μL~Platelet count > 20,000/ μL~Reticulocyte count > 60,000/ μL~Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|12 months||||Participants|||Count of Participants
1281192|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)~Absolute neutrophil count > 500/ μL~Platelet count > 20,000/ μL~Reticulocyte count > 60,000/ μL~Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|6 months||||Participants|||Count of Participants
1281193|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)~Absolute neutrophil count > 500/ μL~Platelet count > 20,000/ μL~Reticulocyte count > 60,000/ μL~Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|3 months||||Participants|||Count of Participants
1281194|NCT00260533|Primary|Clinical Global Impression (Change Version, Also Known as Improvement Version)|"This is a commonly used, clinician-rated measure of clinical improvement.~The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.~For purposes of analysis, subjects rated as (1) Very Much Improved or (2) Much Improved were considered responders."|10 weeks (end of study)||||participants|||Number
1281195|NCT00260429|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment to the primary joint|||||||
1281196|NCT00260429|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment to the primary joint|||||||
1281197|NCT00260429|Secondary|Clinical Success After the First Injection||30 days after first treatment to the primary joint|||||||
1281198|NCT00260429|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint|||||||
1281199|NCT00260429|Secondary|Percent Change From Baseline Range of Motion After the Last Injection||30 days after last treatment to the primary joint|||||||
1281200|NCT00260429|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment to the primary joint|||||||
1281201|NCT00260429|Primary|Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less.~The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|30 days after the last injection||||% Joints|||Number
1281202|NCT00260208|Secondary|Mean Fibrosis Score|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. The mean score was equivalent to mean of IK at 1 and 2 years (evolution over time).|At 1and 2 years and its evolution over time|This outcome was not analyzed because of premature termination of study.|||units on a scale||Standard Deviation|Mean
1281203|NCT00260208|Secondary|Percentage of Participants With an Increase of at Least 1 Stage in Fibrosis|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. An increase of at least 1 stage demonstrated a worsening of the disease, i.e. the transition from one score to the next higher one.|Between 1 and 2 years|The outcome measure was not analyzed because of premature termination of study.|||Percentage of participants|||Number
1281204|NCT00260208|Secondary|Log-transformed Hepatitis C Virus Ribonucleic Acid (HCV RNA) Values up to 1 Year Post Transplant|HCV RNA was measured (IU/µL)centrally pre-transplant (Day 1) and at 48 hours (Day 3), Day 8 and 29, Month 6 and 12 post-transplant and concomitantly to any additional biopsies performed.|Pre-transplant (Day 1), Day , Day 8, Day 29, Month 6 and 12 post- transplant|"Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. n in each of the categories is the number of participants with data at the given time point."|||IU/µL||Standard Deviation|Mean
1283767|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)|Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)|26 week||||percentage of randomized|||Number
1281205|NCT00260208|Secondary|Mean Value of Liver Function Tests at 1 Year Post-transplantation|"The mean value (in Units per liter, IU/L) of following tests were calculated at 1 year post-transplant:~Serum glutamic pyruvic transaminase (SGPT)~Serum Glutamic Oxaloacetic Transaminase (SGOT)~Bilirubin~Alkaline Phosphate~γ-Glutamyltransferase (GGT)"|1 year post-transplant|"Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. n is number participants with assessable data in each category."|||IU/L||Standard Deviation|Mean
1281206|NCT00260208|Secondary|Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant (Intent to Treat Population)|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis.|1 year post-transplant|The Intent-To-Treat (ITT) population consisted of all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
1281207|NCT00260208|Secondary|Number of Participants With Death or Re-transplantation Due to Recurrence of Hepatitis C Cirrhosis|Cirrhosis was resulted due to the recurrence of the hepatitis C virus infection in the transplanted liver.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
1281208|NCT00260208|Secondary|Number of Participants With Combined Endpoint of Death or Graft Loss or Biopsy Proven Acute Rejection (BPAR)|BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
1281209|NCT00260208|Secondary|Number of Participants With Treated Acute Rejection, Biopsy Proven Acute Rejection (BPAR), and Sub-clinical Rejection|Treated acute rejection is defined as an acute rejection, clinically suspected, whether biopsy-proven or not, which has been treated and confirmed by the investigator according to the response to therapy. BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. A sub-clinical rejection was defined as a rejection identified by center driven biopsy, i.e. a biopsy performed routinely at some pre-defined time points after transplantation as per center practice in the absence of any clinical signs of rejection.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
1281210|NCT00260208|Secondary|Number of Participants With Death, Graft Loss, Death or Graft Loss, Graft Loss With Re-transplantation|Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
1281211|NCT00260208|Secondary|Number of Participants With Fibrosing Cholestatic Hepatitis|Fibrosing cholestatic hepatitis (FCH) is characterized by progressive jaundice with a rapid decline in liver function leading to liver failure, most often associated with markedly elevated viral levels detected in the bloodstream (e.g. more than 20 times pre-liver transplantation levels) and in the liver tissue as well. The presence of FCH was reported based on the diagnosis given by the investigator.|1 year post-transplantation|Intent-to-treat population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
1281212|NCT00260208|Secondary|Number of Participants With Combined Endpoint of Death or Graft Loss or Fibrosis Score (FS) ≥ 2|The number of participants with combined end point of death or graft loss or presented with a Ishak-Knodell fibrosis score (FS) ≥2 was calculated. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had liver retransplant or died. Assessment of hepatic fibrosis was performed with liver biopsies read centrally. Ishak-Knodell FS was used to stage liver disease; 0=none; 1=portal fibrosis (some); 2=portal fibrosis (most); 3=bridging fibrosis (few); 4=bridging fibrosis (many); 5=Incomplete cirrhosis; 6=cirrhosis. Higher score indicates greater fibrosis.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
1281213|NCT00260208|Primary|Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. Logistic regression on the presence of IK>=2 was applied based on central biopsy readings only.|1 year post-transplant|The modified intent-to-treat population (mITT) included patients treated with study drug at least up to 30 days before Month 12 visit and a liver biopsy had to be performed at this visit. Also included were patients with an earlier biopsy that showed an Ishak-Knodell fibrosis score ≥2 and treated at least up to 30 days before that biopsy was taken.|||Participants|||Number
1281214|NCT00260195|Primary|Teacher Report of Behavior Problems|Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicates more problems, with total problem area scores ranging from 0 to 40.|Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).||||units on a scale||Standard Deviation|Mean
1281215|NCT00260195|Primary|Parent Report of Behavioral Problems|Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicate more problems, with total scores for problem areas ranging from 0 to 40.|Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).||||units on a scale||Standard Deviation|Mean
1281216|NCT00260195|Primary|Depressive Symptoms|Children’s Depression Inventory (CDI; Kovacs, 1981) This 27-item measure assesses children’s cognitive, affective, and behavioral depressive symptoms. The scale has high internal consistency, moderate test-retest reliability, and correlates in the expected direction with measures of related constructs (e.g., self-esteem, negative attributions, and hopelessness; Kendall, Cantwell, & Kazdin, 1989). Normative data are available (Finch, Saylor, & Edwards, 1985). We used a 26-item version of the scale that omits an item about suicidal ideation. Higher scores indicate more symptoms, and total scores can range from 0 to 52.|Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).||||units on a scale||Standard Deviation|Mean
1281217|NCT00260195|Primary|Post-traumatic Stress Disorder Symptoms|We used the Child PTSD Symptom Scale (CPSS; Foa,Treadwell, Johnson, & Feeny, 2001), to assess PTSD symptoms for both screening into the program and for use in examining child outcomes over time. This scale has been used in school aged children as young as 8 and has shown good convergent and discriminant validity and high reliability (Foa et al., 2001). In our earlier work, scale internal consistency was high (Cronbach’s alpha = 0.89; Jaycox et al., 2002). In this study, we use it as a continuous scale as designed, and also use cut-points to determine eligibility for the study as in prior work (Kataoka et al., 2003; Stein et al., 2003), requiring a total score of 11 or greater, indicating moderate levels of current PTSD symptoms. A high score indicates more symptoms, and total scores can range from 0 to 51.|Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).||||units on a scale||Standard Deviation|Mean
1281218|NCT00260065|Secondary|Best Response and Overall Improvement|Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)|1 year|Intent-to-treat (ITT)|||Participants|||Number
1281219|NCT00260065|Primary|Number of Participants Who Achieved Overall Response|Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)|1 year|Intent-to-treat (ITT)|||participants|||Number
1281220|NCT00259857|Secondary|Participants With Atraumatic Fractures|Number of participants with fractures at the completion of therapy.|24 months|Number of participants with fractures at study completion.|||participants|||Number
1281221|NCT00259857|Secondary|Participants With Atraumatic Fractures|Number of Participants with Atraumatic fractures before therapy.|0 months|Number of participants with fractures before therapy.|||participants|||Number
1281222|NCT00259857|Secondary|Number of Participants With Improvement in BMD of Hip|Analysis was done per protocol and intention to treat.|24 months of therapy|Analysis was done per protocol and intention to treat.|||participants|||Number
1281223|NCT00259857|Primary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy|BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.|24 months therapy|Analysis was done per protocol and intention to treat.|||participants|||Number
1281224|NCT00259857|Secondary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy||12 months of therapy|Analysis was done per protocol and intention to treat.|||participants|||Number
1281225|NCT00259857|Primary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy|Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.|12 months therapy|Analysis was done per protocol and intention to treat.|||participants|||Number
1281226|NCT00259740|Secondary|Complete Response Based on M-Protein Assessments Only|Complete response based on M-protein assessments, as defined for the primary outcome measure.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab|||Participants|||Number
1281227|NCT00259740|Secondary|Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only|Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab|||Participants|||Number
1281228|NCT00259740|Primary|Complete Response or Partial Response Based on M-Protein Assessments Only|Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab|||Participants|||Number
1281229|NCT00259649|Primary|Change in Mean Headache Index Score Among Patients|Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy|baseline to approximately three months||||headache index score||Standard Error|Mean
1281240|NCT00259272|Primary|Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix|This analysis indicates whether the total score is correct and provides enough information, or if subscores need to be calculated. Eigen value, proportion and cumulative are statistical parameters from the Principal Component Analysis, given for each factor.|Baseline|Matrix based on data from all 141 participants.|||value|||Number
1283768|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 12|Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)|12 weeks||||percentage of randomized|||Number
1281230|NCT00259610|Secondary|Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.|Changes in disease progression between treatment groups will be described by the mean score at two years as assessed after adjustment for the baseline radiographic score. Radiographs were observed of hands, wrists, and feet. The range of scores available for the modified Sharp Score is 0 to 448. The erosion score per joint of the hands can range from 0 to 5. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4 with a max score of 60. The erosion score per joint can range from 0 to 10, with each side of the joint independently scored from 0 to 5. The maximal erosion score per foot is thus 60. The joint space narrowing and joint (sub)luxation are combined in a single score with a range of 0 to 4. The maximal narrowing/(sub)luxation score per foot is thus 24.|Year 2, Week 102|The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.|||Scores on a scale||Standard Deviation|Mean
1281231|NCT00259610|Primary|Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)|"Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The ESR is the rate at which red blood cells sediment in a period of one hour.~The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity."|Change of the Mean of DAS28-ESR between weeks 48 - 102.|The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.|||Scores on a scale||Standard Deviation|Mean
1281232|NCT00259298|Primary|Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months|Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).|baseline, 18 months|All participants with a baseline observation and at least 1 post-baseline observation.|||percentage of change of plasma clearance||Inter-Quartile Range|Median
1281233|NCT00259298|Secondary|Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton|Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response.|baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.|||participants|||Number
1281234|NCT00259298|Secondary|Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton|Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting <1% of skeleton; 2=focal areas affecting >=5% of skeleton; 3=focal areas affecting >=20% of skeleton; 4=focal areas affecting >=50% of skeleton.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.|||units on a scale||Standard Deviation|Mean
1281235|NCT00259298|Secondary|Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities|Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.|||percentage of change of skeletal uptake||Inter-Quartile Range|Median
1281236|NCT00259298|Secondary|Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities|Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.|||percentage of change of plasma clearance||Inter-Quartile Range|Median
1281237|NCT00259285|Secondary|Relapse-free Survival|Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.|Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter||||months||Standard Deviation|Mean
1281238|NCT00259285|Secondary|Pathologic Remissions After Surgery|The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.|surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)|7 out of the 10 patients had surgery.|||participants|||Number
1281239|NCT00259285|Primary|Treatment Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|every 21 day cycle (3 cycles) and 3-4 weeks after last cycle||||participants|||Number
1283769|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)|No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)|12 weeks|Intent to treat|||percentage of randomized|||Number
1281241|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink|To assess emotional reactivity with the physiological measure of startle reflex response - by measuring the amplitude of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.|||microvolts||Standard Deviation|Mean
1281242|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink|To assess emotional reactivity with the physiological measure of startle reflex response by measuring the latency of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.|||seconds||Standard Deviation|Mean
1281243|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Skin Conductance|To assess emotional reactivity with the physiological measure of skin conductance, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.|||microvolts||Standard Deviation|Mean
1281244|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Heart Rate|to assess emotional reactivity with the physiological measure of heart rate, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.|||beats per minute||Standard Deviation|Mean
1281245|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
1281246|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
1281247|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
1281248|NCT00259272|Secondary|MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment|A visual analogic scale consisting of 20 items. Items scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18, which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.|Baseline|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
1281249|NCT00259272|Secondary|Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)||24 weeks|Subgroup of patients who gained more than 7% of body weight.|||participants|||Number
1281250|NCT00259272|Secondary|Weight Gain Compared to Baseline|Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline|over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.|||participants|||Number
1281251|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Weight||Baseline and 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.|||kilograms||Standard Deviation|Mean
1281252|NCT00259272|Secondary|Increases and Decreases in Lipid Levels||over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.|||participants|||Number
1281253|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Lipids|Baseline, change from baseline, and percent change for the following lipids are presented: Total Cholesterol (TC), High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), and Triglycerides (TG).|Baseline and 24 Weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.|||milligrams per deciliter||Standard Deviation|Mean
1281254|NCT00259272|Secondary|Increases and Decreases in Fasting Glucose Levels||over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.|||participants|||Number
1281255|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)||baseline and 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.|||milligrams per deciliter||Standard Deviation|Mean
1281256|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
1283770|NCT00218062|Secondary|Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples||16 weeks||||% of riboflavin-positive urine samples|||Number
1281257|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
1281258|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
1281259|NCT00259272|Primary|Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score|A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.|Baseline, 6 Weeks, 24 weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
1281260|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index.|For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)||||Percentage change from baseline||Standard Error|Mean
1281261|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score.|For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)|nine patients with PgR=0 at baseline were excluded from analysis of PgR because the question of medical interest was the effect of treatment on PgR positive patients.|||Percentage change from baseline||Standard Error|Mean
1281262|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.|For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)||||Percentage change from baseline||Standard Error|Mean
1281263|NCT00259012|Primary|Normalized Area of Esophageal Hydrogen Ion Activity Over Time|Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period.|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||H*mmol/L||Standard Deviation|Mean
1281264|NCT00259012|Primary|Normalized Area of Gastric Hydrogen Ion Activity Over Time|Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period.|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||H*mmol/L||Standard Deviation|Mean
1281265|NCT00259012|Primary|Percentage of Time That Intraesophageal pH Was <4|Intraesophagel pH is a method for evaluating acidity of gastric refluxate. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||percentage of time||Standard Deviation|Mean
1281266|NCT00259012|Primary|Median Intraesophageal pH|Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||units on scale||Standard Deviation|Mean
1281267|NCT00259012|Primary|Mean Intraesophageal pH|Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||units on scale||Standard Deviation|Mean
1281268|NCT00259012|Primary|Percentage of Time Intragastric pH Was >4|Intragastric pH is a method for evaluating gastric acidity. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||percentage of time||Standard Deviation|Mean
1281269|NCT00259012|Primary|Median Intragastric pH|Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||units on scale||Standard Deviation|Mean
1281270|NCT00259012|Primary|Intragastric pH|Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||units on scale||Standard Deviation|Mean
1281271|NCT00259012|Primary|Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration|Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.|7 days|All patients for whom at least 2 PK samples were obtained after 5 consecutive doses. Low dose population was 19 for both 2 and 4 hours. High dose population was 17 and 18 for 2 and 4 hours respectively.|||ng/mL||Standard Deviation|Mean
1281272|NCT00259012|Primary|Apparent Oral Clearance (CL/F)|Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||L/hr/kg||Standard Deviation|Mean
1281273|NCT00259012|Primary|Area Under the Concentration-time Curve (AUC)|Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole. AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||ng*hr/mL||Standard Deviation|Mean
1281274|NCT00259012|Primary|Disposition Half-life|Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole. Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||hr||Standard Deviation|Mean
1281275|NCT00259012|Primary|Time to Peak Concentration (Tmax) Profile|Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||hr||Full Range|Median
1281276|NCT00259012|Primary|Peak Concentration (Cmax)|Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||ng/mL||Standard Deviation|Mean
1281277|NCT00258908|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination|The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose|Within 8 days of vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.|||Percentage of Participants|||Number
1281278|NCT00258908|Primary|Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination|GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.|Day 0 and Day 28 post-vaccination|Geometric Mean Titers were evaluated in the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
1281279|NCT00258908|Primary|Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination|Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.|Day 0 and Day 28 Post-vaccination|Seroprotection to each vaccine antigen was evaluated in the per-protocol immunogenicity population|||Percentage of participants|||Number
1281280|NCT00258895|Primary|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination||Day 0 and between Days 28-48 post-dose 5|GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.|||All units||95% Confidence Interval|Geometric Mean
1281281|NCT00258895|Primary|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.||Day 0 and between Days 28-48 Post-dose 5|Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1283771|NCT00218062|Secondary|Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report||16 weeks||||percentage of pills taken|||Number
1281282|NCT00258895|Primary|Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination|Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.|Day 28 to 48 Post-Dose 5|The anti-pertussis booster response was assessed in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1281283|NCT00258895|Primary|Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination|Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.|Day 28 to 48 Post-dose 5|The anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population.|||Percentage of Participants|||Number
1281284|NCT00258895|Primary|Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination||0 to 7 days Post-Dose 5|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Percentage of Participants|||Number
1281285|NCT00258882|Primary|Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls.|Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.|Pregnancy to Delivery, up to 9 months|All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine.|||Infants|||Number
1281286|NCT00258882|Primary|Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls|Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.|Pregnancy to Delivery, up to 9 months|All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine.|||Participants|||Number
1281287|NCT00258882|Primary|All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.|Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study.|Days 0 to 180 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.|||Events per 1000 Person-months|||Number
1281288|NCT00258882|Primary|All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.|Surveillance for acute onset outcomes occurring shortly (days to weeks) after vaccination was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of acute events. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination|Days 0 to 60 and Day 61 to 120 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.|||Events Per 1000 Person-months|||Number
1281289|NCT00258882|Primary|Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database|"The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; ITP; Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.~Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study."|Days 0 up to 180 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.|||Events Per 1000 Person-months|||Number
1281313|NCT00258674|Primary|"Change Score for Blood Pressure (b.p.) <130/80 mmHg"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of blood pressure <130/80 mmHg at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001)|Patients missing either a baseline or follow-up blood pressure value were excluded.|||units on a scale||Standard Deviation|Mean
1281290|NCT00258882|Primary|Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database|"The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; Idiopathic Thrombocytopenic Purpura (ITP); Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.~Comparison of events rates was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of pre-specified outcomes of interest. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination."|Days 0 to 60 and Day 61 to 120 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.|||Events Per 1000 Person-months|||Number
1281291|NCT00258856|Primary|Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.|"Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.~Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination."|7 or 14 days post-vaccination|Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Percentage of participants|||Number
1281292|NCT00258830|Other Pre-specified|Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination|Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination.|Day 21 post-vaccination|Seroconversion was assessed in the per-protocol population.|||Percentage of participants|||Number
1281293|NCT00258830|Other Pre-specified|Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.|Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination.|21 Days post-vaccination|Seroprotection was assessed in the per-protocol population|||Percentage of participants|||Number
1281294|NCT00258830|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination|GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005–2006 Formulation)|21 days post-vaccination|GMT results were assessed on the per-protocol population.|||Titer||95% Confidence Interval|Geometric Mean
1281295|NCT00258830|Primary|Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination||Day 0 to 3 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects intent-to-treat safety population with available reaction data.|||Participants|||Number
1281296|NCT00258817|Other Pre-specified|Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2|"Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting~Note: Influenza vaccine-primed group received only dose 1"|0 to 3 days post-vaccination 2|Safety analysis post vaccination 2 was on all enrolled and vaccinated subjects, Intend-to-treat population.|||Participants|||Number
1281297|NCT00258817|Other Pre-specified|Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1|Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.|0 to 3 days post-vaccination 1|Safety analysis post-vaccination 1 was on all enrolled and vaccinated subjects, Intend-to-treat population.|||Participants|||Number
1281298|NCT00258817|Primary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination|"GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation.~Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)"|Day 14 post-vaccination|Geometric Mean Titers were assessed on the per-protocol population.|||Titer||95% Confidence Interval|Geometric Mean
1281299|NCT00258674|Secondary|"Change Score for Semiannual HbA1c Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for a semi-annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
1281300|NCT00258674|Secondary|"Change Score for Annual Lipid Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
1281301|NCT00258674|Secondary|"Change Score for Annual Eye Exam (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
1283772|NCT00218062|Primary|Retention as Indicated by the Number of Participants Who Remained in the Study||16 weeks||||participants|||Number
1281302|NCT00258674|Secondary|"Change Score for Annual HbA1c Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
1281303|NCT00258674|Secondary|"Change Score for Annual Renal Function Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual renal function assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
1281304|NCT00258674|Secondary|"Change Score for Annual Eye Exam (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
1281305|NCT00258674|Secondary|"Change Score for Annual Foot Exam (as Determined by Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual foot exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom baseline or follow-up records were not available were excluded.|||units on a scale||Standard Deviation|Mean
1281306|NCT00258674|Secondary|"Change Score for Annual Blood Pressure Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual blood pressure assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom either baseline or follow-up records were missing were excluded.|||units on a scale||Standard Deviation|Mean
1281307|NCT00258674|Secondary|"Change Score for Annual Lipid Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom either baseline or follow-up records were missing were excluded.|||units on a scale||Standard Deviation|Mean
1281308|NCT00258674|Secondary|"Change Score for Annual HbA1c Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were missing for either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
1281309|NCT00258674|Secondary|"Change Score for Systolic Blood Pressure"|Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up blood pressure measurement were excluded.|||mmHg||Standard Deviation|Mean
1281310|NCT00258674|Secondary|"Change Score for LDL Level"|Change score was calculated by subtracting the follow-up LDL value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either baseline or follow-up LDL values were excluded.|||mg/dL||Standard Deviation|Mean
1281311|NCT00258674|Secondary|"Change Score for Diastolic Blood Pressure"|Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up blood pressure measurement were excluded.|||mmHg||Standard Deviation|Mean
1281312|NCT00258674|Secondary|"Change Score for HbA1c Level"|Change score was calculated by subtracting the follow-up HbA1c value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up HbA1c value were excluded.|||change in percentage of glycosolated-Hb||Standard Deviation|Mean
1281314|NCT00258674|Primary|"Change Score for LDL <100 mg/dL"|"Each patient was assigned a change score of –1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of LDL <100 mg/dL at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm."|change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001)|Patients missing either baseline or follow-up LDL values were excluded.|||units on a scale||Standard Deviation|Mean
1281315|NCT00258674|Primary|"Change Score for HbA1c <9 Percent"|"Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient non-adherent to the guideline recommendation for HbA1c <9 percent at baseline had achieved such a level at follow up. Patient-level change scores were then summed and averaged over each study arm."|This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)|Patients missing either baseline or follow-up values for HbA1c were excluded.|||units on a scale||Standard Deviation|Mean
1281316|NCT00258440|Secondary|Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.||On study, averaging 3 to 6 months.||||events|||Number
1281317|NCT00258440|Secondary|Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28||weeks 4,8,16,24 and 28|||||||
1281318|NCT00258440|Secondary|Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.||every other week|||||||
1281319|NCT00258440|Primary|Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks||12 weeks|Due to low accrual numbers and the discontinuation of the study early a full analysis was not completed.|||participants|||Number
1281320|NCT00258362|Secondary|Percent of Patients Estimated to be Alive|This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.|1 Year, 2 Years, 3 Years|All 41 patients were included in this analysis.|||Percentage of Patients|||Number
1281321|NCT00258362|Primary|Percent of Patients Estimated to be Progression-Free and Alive|This estimate was determined by using a statistical method of analysis (Kaplan-Meier).|1 Year, 2 Years, 3 Years|Two patients with recurrent disease at study entry were excluded from this analysis.|||Percentage of Patients|||Number
1281322|NCT00258349|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause. Patients who were alive were censored as the last date of known alive.|Survival was assessed every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry|10 eligible HER2-positive (by central review) patients|||months||95% Confidence Interval|Median
1281323|NCT00258349|Secondary|Time to Progression|Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Disease progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). Time to progression is defined as time from registration to disease progression.|Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy|10 eligible HER2-positive (by central review) patients|||months||95% Confidence Interval|Median
1281324|NCT00258349|Primary|Response Rate|Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy|10 eligible HER2-positive (by central review) patients|||percentage of participants||95% Confidence Interval|Number
1281325|NCT00258310|Secondary|Incidence of Second Primary Tumor Occurrence||Every 12 months|||||||
1281326|NCT00258310|Secondary|Survival Rate||from time of study entry until death|||||||
1281327|NCT00258310|Secondary|Local-regional Control Rate Occurrence||within 365 days|||||||
1281328|NCT00258310|Secondary|Time to Recurrence||assessed from time of study entry until documented|||||||
1281329|NCT00258310|Primary|Feasibility of Treatment as Assessed.|Compliance was taking at least 80% of the prescribed dose for one year.|within 365 days||||percentage of participants||95% Confidence Interval|Number
1281330|NCT00258206|Secondary|Overall Survival||5 years|||||||
1281331|NCT00258206|Secondary|Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited||2, 3, 6, 9, and 12 months|||||||
1281332|NCT00258206|Secondary|Complete Response (CR) Rate and Partial Response (PR) Rate||1 year|||||||
1281333|NCT00258206|Secondary|Safety and Toxicity||2, 3, 6, 9, and 12 months|||||||
1281334|NCT00258206|Primary|Safety of Maintenance Rituximab Following High Dose Cyclophosphamide||2, 3, 6, 9, and 12 months|||||||
1281335|NCT00258206|Primary|Event-free Survival|Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)|1 year||||percentage of participants|||Number
1281336|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281337|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281338|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281339|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1282167|NCT00247273|Secondary|Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population|ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.|Baseline to Month 6|ITT|||ng / mL||95% Confidence Interval|Least Squares Mean
1281340|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281341|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281342|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281343|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281344|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281345|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1|GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281346|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen|GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281347|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1|GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
1281348|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
1281349|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
1281350|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
1281351|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
1281352|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Least Squares Mean
1281353|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
1281354|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset B (subjects with odd allocation numbers|||Dilution Unit||95% Confidence Interval|Geometric Mean
1281355|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset B (subjects with odd allocation numbers)|||IU/mL||95% Confidence Interval|Geometric Mean
1281356|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset B (subjects with odd allocation number)|||IU/mL||95% Confidence Interval|Geometric Mean
1281357|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset B (subjects with odd allocation number)|||IU/mL||95% Confidence Interval|Geometric Mean
1281358|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
1281359|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
1281360|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after in a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
1281361|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Pre-dose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
1281362|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa , 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
1281363|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen|GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen|42 days after a 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.|||ng/mL||95% Confidence Interval|Geometric Mean
1281364|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1|GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen|Day 1 of 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.|||ng/mL||95% Confidence Interval|Geometric Mean
1281365|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen|GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen|42 days after 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
1281366|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
1281367|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1|Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen|Day 1 of a 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
1281398|NCT00257608|Secondary|Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase|Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).|Approximately 3 years|Enrolled participants: All participants who were enrolled in the study. N= Number of participants analyzed.|||participants|||Number
1281368|NCT00258011|Secondary|Urinary Glycosaminoglycan (GAG) Excretion|Percentage change in the concentration of GAG relative to creatinine in urine (ug GAG/mg creatinine) from baseline to last study visit. Greater decrease indicates greater response.|Up to 73 Weeks|"The study enrolled eligible MPS I patients prior to marketing authorization in Japan. The analysis was intention to treat. >~* 1 patient final visit = Week 73; 1 patient final visit = Week 32; 1 patient final visit = Week 10"|||percent change in concentration of GAG||Standard Deviation|Mean
1281369|NCT00258011|Primary|Safety Evaluation|Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.|Up to 73 Weeks|The study enrolled eligible MPS I patients prior to marketing authorization in Japan. The analysis was intention to treat.|||participants|||Number
1281370|NCT00257933|Secondary|Rate of Relapse Between Treatment Groups||2 weeks after hospitalization|||||||
1281371|NCT00257933|Secondary|Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups||Every 4 hours during hospitalization|||||||
1281372|NCT00257933|Secondary|The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups||Every 4 hours during hospitalization|||||||
1281373|NCT00257933|Secondary|Time Spent in Each Severity Level of the Asthma Care Pathway||Time spent in each severity level of pathway|||||||
1281374|NCT00257933|Secondary|Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order||Mean time from writing admit order until discharge order|||||||
1281375|NCT00257933|Primary|Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered||Median time from loading dose to home dose of albuterol||||Hours||Inter-Quartile Range|Median
1281376|NCT00257920|Primary|Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)|Calcium Absorption Fraction obtained at the end of Period 1 & Period 2|42 Days|Per-Protocol Population - all subjects who completed both Period 1 and 2 and did not have major protocol violations.|||Fractions||Standard Error|Least Squares Mean
1281377|NCT00257920|Secondary|Calcium Absorption Fractions Analyzed by Mixed Model|Calcium Absorption Fraction obtained at the end of Period 1 & Period 2|42 Days|ITT Population -all randomized subjects who received at least one dose of study drug and were analyzed by the randomized treatment sequence assigned to each subject.|||Fractions||Standard Error|Least Squares Mean
1281378|NCT00257894|Primary|Minnesota Nicotine Withdrawal Questionnaire|"Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal).~These data are only available on the subset of participants who participated through Day 10."|Day 10||||units on a scale||Standard Deviation|Mean
1281379|NCT00257894|Secondary|Cigarette Choice Task|"At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed).~These data are only available on the subset of participants who participated through Day 10."|Tenth day of medication titration||||choices||Standard Deviation|Mean
1281380|NCT00257894|Secondary|Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.|"Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse).~These data are only available on the subset of participants who participated through Day 10.."|Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.||||units on a scale||Standard Deviation|Mean
1281381|NCT00257894|Primary|Total Score on Questionnaire of Smoking Urges|"Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge).~These data are only available on the subset of participants who participated through Day 10."|Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.||||units on a scale||Standard Deviation|Mean
1281382|NCT00257686|Secondary|Percent Change From Baseline in TC|Percent change from baseline in total cholesterol (TC)|Baseline to 12 weeks||||Percent change||Standard Deviation|Mean
1281383|NCT00257686|Primary|Percent Change From Baseline in LDL-C|Percent change from baseline in low density cholesterol (LDL-C)|Baseline to 12 weeks||||Percent change||Standard Deviation|Mean
1281384|NCT00257660|Secondary|Number of Participants Considered by the Investigator to be Overall Treatment Successes|The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.|Week 12|Analysis was performed on intention to treat population which consisted of 55 participants on Dysport and 61 on Placebo.|||participants|||Number
1281385|NCT00257660|Secondary|SF-36 Physical Health Summary Score|SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).|Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in physical health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
1281386|NCT00257660|Secondary|SF-36 Mental Health Summary Score|SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).|Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in mental health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
1281414|NCT00257322|Primary|Participants Exhibiting Immune Response|Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.|24 Months||||Participants|||Count of Participants
1281387|NCT00257660|Secondary|Investigator's VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).|Baseline and week 12|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline, Week 4 and Week 8 values.|||points on a scale||Standard Deviation|Mean
1281388|NCT00257660|Secondary|Subject VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and week 12|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline, Week 4 and Week 8 values.|||points on a scale||Standard Deviation|Mean
1281389|NCT00257660|Secondary|Investigator's VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline and Week 4 values.|||points on a scale||Standard Deviation|Mean
1281390|NCT00257660|Secondary|Subject VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).|Baseline and Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline and Week 4 values.|||points on a scale||Standard Deviation|Mean
1281391|NCT00257660|Secondary|Investigator VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis was performed on intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
1281392|NCT00257660|Secondary|Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 5 subjects on Dysport and 8 on placebo who were not assessed on the change in subject VAS score for CD symptoms at Week 4. There was no imputation of missing VAS scores, so these 13 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
1281393|NCT00257660|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 12|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 10 subjects for Dysport and 17 for placebo who were not assessed on TWSTRS score at Week 12. As there was no imputation of missing TWSTRS score values, these 27 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
1281394|NCT00257660|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 8|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 9 subjects for Dysport and 15 for placebo who were not assessed on TWSTRS score at Week 8. As there was no imputation of missing TWSTRS score values, these 24 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
1281395|NCT00257660|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 4|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
1281396|NCT00257608|Secondary|Overall Survival|Overall survival was defined as the length of time from randomization to death.|Approximately 3.5 years|Intent-to-treat population included all participants who were randomized during the post-chemotherapy phase.|||months||95% Confidence Interval|Median
1281397|NCT00257608|Secondary|Incidence of Study Treatment Discontinuation|Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.|Approximately 3 years|Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.. N= Number of participants analyzed.|||participants|||Number
1282223|NCT00246376|Primary|Non-HDL-C|non-HDL-C (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||mg/dl||Standard Error|Mean
1281399|NCT00257608|Secondary|Number of Participants With Any Adverse Events During Post-Chemotherapy Phase|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.|Approximately 3.5 years|Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed. At the time of the 28 January 2009 data cutoff, an additional 25 patients had been randomized.|||participants|||Number
1281400|NCT00257608|Secondary|Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase|Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade >=3. Data presented until cut-off date 28 January 2009.|Approximately 3 years|Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed.|||participants|||Number
1281401|NCT00257608|Secondary|Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase|Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade >=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.|Approximately 3 years|Safety-evaluable enrolled participants: All participants who enrolled and received at least one dose of chemotherapy or Bevacizumab. N= Number of participants analyzed.|||participants|||Number
1281402|NCT00257608|Primary|Progression-free Survival (PFS)|PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.|Approximately 3 years|Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.|||months||95% Confidence Interval|Median
1281403|NCT00257556|Secondary|Mean Estradiol Level|Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.|Day 7 or 9 or 11 or 13|All patient treated population|||picomoles / liter||Standard Deviation|Mean
1281404|NCT00257556|Secondary|Mean Endometrial Thickness|Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.|Day 7 or 9 or 11 or 13|All patients treated population|||millimeters||Standard Deviation|Mean
1281405|NCT00257556|Secondary|Pregnancy Outcomes|Long term follow-up to determine the outcome of the pregnancy.|Approximately 10 months|All patients treated population|||participants|||Number
1281406|NCT00257556|Secondary|Mean Number of Days Stimulated With Gonadotrophins|Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.|study days 1 - 13|All patients treated population|||days||Standard Deviation|Mean
1281407|NCT00257556|Secondary|Participants With Varying Numbers of Embryos Frozen|Number of participants with different categories of number of embryos frozen.|Approximately study day 17|All patients treated population|||participants|||Number
1281408|NCT00257556|Secondary|Participants With Varying Numbers of Embryos Transferred|Number of participants with various categories of numbers of embryos transferred.|Approximately study day 17|All patients treated population|||participants|||Number
1281409|NCT00257556|Secondary|Participants With Varying Numbers of Pronuclear Stage Oocytes|Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.|Approximately study day 15|All patients treated population|||participants|||Number
1281410|NCT00257556|Secondary|Participants With Varying Numbers of Oocytes Retrieved|Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter.|Approximately study day 15|All treated patients population.|||participants|||Number
1281411|NCT00257556|Secondary|Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters|The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.|Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)|All treated patients population|||participants|||Number
1281412|NCT00257556|Primary|Percentage of Participants With an Ongoing Pregnancy|Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.|Approx week 13; 9 weeks or more after the first positive pregnancy test|"All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as YES for ongoing pregnancy."|||percentage of participants|||Number
1281413|NCT00257556|Primary|Number of Participants With an Ongoing Pregnancy|Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.|Approx week 13; 9 weeks or more after the 1st positive pregnancy test|All patients treated population|||participants|||Number
1281415|NCT00257322|Secondary|Response Rates and Overall Survival.|Effect of cellular immune stimulation on response rates and overall survival. This is a secondary endpoint and while data will be recorded, a larger study with improved power will be necessary to confirm any improvements noted.|24 Months||||Participants|||Count of Participants
1281416|NCT00257309|Primary|Death/Reinfarction/Disabling Stroke at 30 Days|Incidence of Death or Reinfarction or Disabling Stroke at 30 days|30 days||||Participants|||Count of Participants
1281417|NCT00257309|Primary|Incidence of Death or Reinfarction or Disabling Stroke|Incidence of all-cause death or myocardial reinfarction or disabling stroke|30 days||||participants|||Number
1281418|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.|||participants|||Number
1281419|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Attendance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.|||participants|||Number
1281420|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Situation|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.|||participants|||Number
1281421|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score|AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1281422|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item|BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1281423|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)|SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1281432|NCT00257192|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Week 6|CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
1281760|NCT00252512|Secondary|VHA Healthcare Service Utilization|Cost of total healthcare utilization for six month period between baseline and 6 month follow up and six month period between 6 month and 12 month follow up.|Baseline to 6 month follow up and 6 month follow up to 12 month follow up.||||Dollars||Standard Deviation|Mean
1281424|NCT00257192|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index|A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Week 6, ET|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).|||scores on a scale||Standard Deviation|Mean
1281425|NCT00257192|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales|A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Week 6, ET|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).|||scores on a scale||Standard Deviation|Mean
1281426|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).|Baseline, Week 2, Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1281427|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1281428|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1281429|NCT00257192|Secondary|Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score|CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1281430|NCT00257192|Secondary|Change From Baseline in Child Health Questionnaire (CHQ)|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child’s physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Week 6, ET|ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1281431|NCT00257192|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the “normal” range; lower score indicates need for increased supervision.|Baseline, Week 2, Week 4, Week 6, Early termination (ET)|ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward [LOCF] imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
1282224|NCT00246376|Secondary|Body Composition|"Body cell mass (kg)~Fat mass (kg)"|Measured at 24 weeks|The number corresponds to the number of subjects who completed the study (see Participant flow)|||kg||Standard Error|Mean
1281433|NCT00257192|Secondary|Change From Baseline in PANSS: Positive and Negative Subscales at Week 6|PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
1281434|NCT00257192|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6|PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
1281435|NCT00257192|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6|CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
1281436|NCT00257192|Primary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline, Week 6|Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
1281437|NCT00257166|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 1, 2, 3, 4|ITT population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1281438|NCT00257166|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).|Baseline, Week 1, 2, 3, 4|ITT population. Here, ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1281439|NCT00257166|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3|YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.|Baseline, Week 1, 2, 3|ITT population. ‘N’ (number of participants analyzed) signifies those participants who were available for this measure. ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1281440|NCT00257166|Primary|Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4|YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.|Baseline, Week 4|Intent-to-treat (ITT): all randomized participants who had baseline measurements, took at least (>=) 1 dose of study medication (ziprasidone or placebo) and had >=1 post-baseline visit. Here, ‘n’ signifies those participants who were available for this measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
1281441|NCT00257010|Secondary|Number of Headaches With Vomiting|Occurrence and intensity of vomiting post-dose of study medication. Vomiting is an act or instance of disgorging the contents of the stomach through the mouth also called emesis.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches with vomiting|Participants||Number
1281442|NCT00257010|Secondary|Number of Headaches With Nausea|Occurrence and intensity of nausea post-dose of study medication. Nausea is a feeling of sickness characterized by gastrointestinal distress and an urge to vomit.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches with nausea|Participants||Number
1281443|NCT00257010|Secondary|Number of Headaches With Phonophobia|Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches with phonophobia|Participants||Number
1282225|NCT00246376|Secondary|Insulin Sensitivity|Adiponectin (micrograms/ml)|Measured at 24 weeks|All subjects who completed 24 weeks.|||micrograms/ml||Standard Error|Mean
1281444|NCT00257010|Secondary|Number of Headaches With Photophobia|Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches with photophobia|Participants||Number
1281445|NCT00257010|Secondary|Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose|Headache pain relief is defined as a decrease in baseline pain intensity from either severe or moderate intensity to mild or no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain relief is defined as pain relief at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.|2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches|Participants||Number
1281446|NCT00257010|Primary|Number of Pain Free Headaches at 2 and 24 Hours Post-Dose|Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.|2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches|Participants||Number
1281447|NCT00256997|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline and End of Study (Month 24 or Early Termination [ET])|ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Units on a scale||Standard Error|Mean
1281448|NCT00256997|Secondary|Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24|"AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the value of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state)”."|Baseline and Month 24|ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Units on a scale||Standard Deviation|Mean
1281449|NCT00256997|Secondary|Number of Participants With Response to Resource Utilization Questionnaire (RUQ)|This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study [Visit 6, Month 24]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Participants|||Number
1281450|NCT00256997|Secondary|Number of Participants With Clinical Global Impression of Change (CGI-C)|The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.|End of Study (Month 24 or Early Withdrawal [EW])|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Participants|||Number
1281451|NCT00256997|Secondary|Number of Participants With Clinical Global Impression of Severity (CGI-S)|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline and End of Study (Month 24 or Early Withdrawal [EW])|ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||participants|||Number
1281576|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Pulse Rate||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||beats per minute||Standard Deviation|Mean
1281452|NCT00256997|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Month 24|ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Units on a scale||Standard Deviation|Mean
1281453|NCT00256997|Secondary|Time in Symptomatic (Having Symptoms) Remission|Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration.|Baseline up to Month 24|Data for this outcome was not computed as it was not defined in terms of the formula for calculation and thus was not included in analysis plan.||||||
1281454|NCT00256997|Secondary|Time to First Clinical Exacerbation|Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant’s schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Months||Standard Error|Mean
1281455|NCT00256997|Secondary|Percentage of Participants Who Experienced a Clinical Exacerbation|Clinical exacerbation is defined as hospitalization because of participant’s schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Percentage of participants|||Number
1281456|NCT00256997|Primary|Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization|Clinical exacerbation is defined as hospitalization because of participant’s schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Month 3 up to Month 24|Intent-to-treat (ITT) population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Percentage of participants|||Number
1281457|NCT00256984|Secondary|SF-12 QOL Change (Mental Component) at 12 Months From Baseline|SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.|Baseline, 12 months||||units on a scale||Standard Deviation|Mean
1281458|NCT00256984|Secondary|SF-12 QOL Change From Baseline (Physical Component)at 12 Months|The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.|Baseline, 12 Months||||units on a scale||Standard Deviation|Mean
1281459|NCT00256984|Secondary|PAC QOL Patient Assessment of Constipation (Overall)|PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol|Baseline, 12 months|Sizing consistent with primary outcome; analysis was Intent-to-Treat|||units on a scale||Standard Deviation|Mean
1281460|NCT00256984|Secondary|Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)|The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.|Baseline, 6 months post procedure||||percentage of change||Standard Deviation|Mean
1281461|NCT00256984|Secondary|Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).|Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
1282226|NCT00246376|Primary|Triglycerides|Triglycerides (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||mg/dL||Standard Error|Mean
1281462|NCT00256984|Secondary|Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure|Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.|Baseline, 1 month post procedure||||percentage of change||Standard Deviation|Mean
1281463|NCT00256984|Primary|Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure|The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.|one year from Baseline|Per protocol|||percentage of change||Standard Deviation|Mean
1281464|NCT00256867|Secondary|Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline|The clinical chemistry parameters analyzed were sodium, potassium, bicarbonate, chloride, calcium, total protein, albumin, creatinine total bilirubin, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and alkaline phosphatase. The hematology parameters analyzed were hemoglobin, hematocrit, platelet count, total white cell count. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.|Up to Week 16|Safety population|||Participants|||Count of Participants
1281465|NCT00256867|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Week 16|Safety population.|||Participants|||Count of Participants
1281466|NCT00256867|Secondary|Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine|Urine samples were observed for red blood cells and white blood cells. the results were reported as cells per high-power field (cells/HPF). The number of participants with cells in urine were reported.|Up to Week 16|Safety population|||Participants|||Count of Participants
1281467|NCT00256867|Secondary|On-Therapy Change From Baseline in Body Weight|Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. Change from Baseline was computed as: Visit value - Baseline Value.|Up to Week 16|Safety Population. Only those participants available at the specified time points were analyzed.|||Kilogram||Standard Deviation|Mean
1281468|NCT00256867|Secondary|On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to Week 16|Safety Population comprised of all participants who were randomized and received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1281469|NCT00256867|Secondary|Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16|Number of participants achieving ADA target of FPG< 126 mg/dL (7.0 mmol/L) or reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 was compared between the all SIM monotherapy group and the all FDC RSG/SIMV groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.|Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1281470|NCT00256867|Secondary|Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16|Number of participants achieving ADA target of HbA1c < 7.0% or reduction of HbA1c ≥ 0.7% at Week 16 was compared between the FDC groups and the RSG groups groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.|Up to Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1281471|NCT00256867|Secondary|Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6|Number of participants achieving American Diabetes Association (ADA) target of LDL<100 mg/dL (2.59 mmol/L) at Week 6 was compared between the FDC groups and the all SIMV group using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.|Week 6|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1281472|NCT00256867|Secondary|Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)|Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.|Baseline (Week 0) and Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Millimol per litre (mmol/L)||Standard Deviation|Mean
1281473|NCT00256867|Secondary|Mean Change From Baseline to Week 16 in HbA1c|Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.|Baseline (Week 0) and Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||mg/dl||Standard Deviation|Mean
1282016|NCT00249249|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|percent change from baseline in high density lipoprotein-cholesterol (HDL-C)|Baseline to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||percent change||Standard Deviation|Mean
1281474|NCT00256867|Secondary|Median Percent Change From Baseline to Week 6 in LDL-c|Percent change from Baseline = 100*(exponent [change on log scale]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.|Baseline (Week 0) and Week 6|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Percent change in LDL-c||Full Range|Median
1281475|NCT00256867|Secondary|Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy|Mean change from Baseline to Week 16 in HbA1c in FDC and SIMV monotherapy was reported. Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of ANCOVA with terms for treatment, gender, current sulfonylurea use (at Baseline), country, and Baseline measurement.|Baseline (Week 0) and Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time point were analyzed.|||mg/dL||Standard Deviation|Mean
1281476|NCT00256867|Primary|Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy|Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100*(exponent [change on log scale]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.|Baseline (Week 0) and Week 6|Intent-to-Treat Population comprised of all participants who were randomized and had at least one On-Therapy value for an efficacy assessment. The Intent-to-Treat population with last observation carried forward (LOCF) was used for efficacy analyses. Only those participants available at the specified time points were analyzed.|||Percent change in LDL-c||Full Range|Median
1281477|NCT00256750|Secondary|Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
1281478|NCT00256750|Secondary|Percent of Participants Surviving With a Functioning Graft|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.|Months 24, 36|All randomized and transplanted participants, intent to treat (ITT) population. For 95% CI within each group, normal approximation is used in N>=5. Otherwise exact method is used.|||percentage of participants||95% Confidence Interval|Number
1281479|NCT00256750|Secondary|Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Baseline to Months 6, 12, 24, and 36|All randomized and transplanted participants, intent to treat (ITT) population|||units on a scale||Standard Error|Mean
1281480|NCT00256750|Secondary|Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Baseline to Months 6, 12, 24,and 36|All randomized and transplanted participants, intent to treat (ITT) population|||units on a scale||Standard Deviation|Mean
1281529|NCT00256308|Secondary|Sites of Relapse|Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.|2 years|4 participants completed the study without any signs of disease. Only 1 participant had progressive disease but does not appear to be a relapse. No information provided to indicate whether other expired participant experienced a relapse.|||Participants|||Count of Participants
1281481|NCT00256750|Secondary|Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)|The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population.|||Ridit score||Standard Error|Mean
1281482|NCT00256750|Secondary|Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population|||units on a scale||Standard Deviation|Mean
1281483|NCT00256750|Secondary|Mean Value of Physical and Mental Components Using SF-36 Questionnaire|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population|||units on a scale||Standard Deviation|Mean
1281484|NCT00256750|Secondary|Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36|Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||participants|||Number
1281485|NCT00256750|Secondary|Percent of Participants With Subclinical Rejection at Month 12|Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281486|NCT00256750|Secondary|Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12|Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine [SCr] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)|Randomization to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with at least one episode of AR up to Month 12|||participants|||Number
1283773|NCT00218062|Primary|Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment||16 weeks||||participants|||Number
1281487|NCT00256750|Secondary|Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36|Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants|||Number
1281488|NCT00256750|Secondary|Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36|The use of LDT (thymoglobulin or antithymocyte gamma globulin [ATGAM]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants|||Number
1281489|NCT00256750|Secondary|Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12|A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met >= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output < 250 mL/12 hours, no significant improvement (< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.|Randomization to Month 12|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
1281490|NCT00256750|Secondary|Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36|Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||participants|||Number
1281491|NCT00256750|Secondary|Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36|Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
1281492|NCT00256750|Secondary|Mean Value of Lipid Parameters|Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).|Months 12, 24, 36|All randomized and transplanted participants, intent-to-treat (ITT) population|||mg/dL||Standard Deviation|Mean
1281493|NCT00256750|Secondary|Percent of Participants Using At Least One Anti-Hyperlipidemic Medication|This analysis is based on all participants who were followed up at least 1092 days after transplantation.|Month 36|All randomized and transplanted participants, intent-to-treat (ITT) population; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.|||percentage of participants||95% Confidence Interval|Number
1281530|NCT00256308|Secondary|Overall Survival Rate|"Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.~From date of registration to date of death due to any cause"|2 years|4 participants completed follow up period. 2 participants expired in the follow up period. 1 due to progressive disease and 1 due to staph infection and secondary cause of death due to disease complications.|||Participants|||Count of Participants
1281494|NCT00256750|Secondary|Number of Participants With Antihyperlipidemic Medication by Intensity Level|An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.|Month 36|All randomized and transplanted participants that received at least one hyperlipidemic medication; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.|||participants|||Number
1281495|NCT00256750|Secondary|Percent of Participants With Controlled Dyslipidemia at Month 12|Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Month 12|All randomized and transplanted participants, intent-to-treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
1281496|NCT00256750|Secondary|Percent of Participants With Prevalence of Dyslipidemia at Month 12|The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281497|NCT00256750|Secondary|Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12|Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Randomization to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281498|NCT00256750|Secondary|Percent of Participants With Prevalence of Controlled Hypertension at Month 12|The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281499|NCT00256750|Secondary|Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12|Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with baseline hypertension|||percentage of participants||95% Confidence Interval|Number
1281500|NCT00256750|Secondary|Mean Systolic Blood Pressure and Diastolic Blood Pressure|Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.|Months 12, 24, 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mmHg||Standard Deviation|Mean
1281545|NCT00256126|Secondary|Change From Baseline in Fasting Insulin Levels at Month 1||Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||picomole per liter (pmol/L)||Standard Deviation|Mean
1281501|NCT00256750|Secondary|Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12|The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281502|NCT00256750|Secondary|Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12|The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281503|NCT00256750|Secondary|Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36|This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP < 130 mm Hg and a DBP < 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281504|NCT00256750|Secondary|Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36|The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is >=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)|Week 4 post-transplantation to Month 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281505|NCT00256750|Secondary|Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12|Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m^2|Month 6 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mL/Min/1.73 m^2||Standard Deviation|Mean
1281506|NCT00256750|Secondary|Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation|Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2|Months 6, 12, 24, 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mL/min/1.73 m^2||Standard Deviation|Mean
1281507|NCT00256750|Secondary|Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281508|NCT00256750|Secondary|Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline|Month 3 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281546|NCT00256126|Secondary|Change From Baseline in Fasting Glucose Levels at Month 1||Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1281547|NCT00256126|Secondary|Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1||Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||milligram per liter (mg/L)||Standard Deviation|Mean
1281509|NCT00256750|Secondary|Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.|Month 3 to Month 12; Month 3 to Month 24|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mL/min/1.73m^2||Standard Deviation|Mean
1281510|NCT00256750|Secondary|Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84|Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.|Randomization to Month 84|All randomized, transplanted, and treated participants; intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
1281511|NCT00256750|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36|"Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L).~Hemoglobin (low): <8.0 g/dL; Platelet count: <50*10^9 c/L; Leukocytes: <2*10^3 c/µL; Alkaline phosphatase (ALP): >5.0*ULN U/L; Alanine aminotransferase (ALT): >5.0*ULN U/L; Asparate aminotransferase (AST): >5.0*ULN U/L; Bilirubin Total: >3.0*ULN mg/dL; Creatinine: >3.0*ULN mg/dL; Calcium Total: low if <7.0 mg/dL or high if >12.5 mg/dL; Bicarbonate: <11.0 mEq/L; Potassium serum: low if <3.0 mEq/L or high if >6.0 mEq/L; Magnesium serum: low is <0.8 mEq/L or high if >2.46 mEq/L; Sodium serum: low if <130.0 mEq/L or high if >155.0 mEq/L; Phosphorus inorganic: <2.0 mg/dL; Albumin: <2 g/dL; Uric acid: >10 mg/dL; Protein urine: >=3+"|Baseline to Month 36|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population|||participants|||Number
1281512|NCT00256750|Secondary|Mean Blood Pressure at Month 84|Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.|Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE).|||mmHg||Standard Deviation|Mean
1281513|NCT00256750|Secondary|Number of Participants With Adverse Events of Special Interest by Month 84|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.|Randomization to Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)|||participants|||Number
1281514|NCT00256750|Secondary|Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Randomization to Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)|||participants|||Number
1281515|NCT00256750|Secondary|Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12|Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component; Any participant not meeting CAN criteria and who has no biopsy either prior to or post 12 months and no GFR assessment (either measured or calculated) available were excluded from the analyses.|||percentage of participants||95% Confidence Interval|Number
1281577|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Diastolic Blood Pressure||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mm Hg||Standard Deviation|Mean
1281516|NCT00256750|Secondary|Mean Value of the Measured Glomerular Filtration Rate (mGFR)|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.|Months 3, 12, 24|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mL/min/1.73m^2||Standard Deviation|Mean
1281517|NCT00256750|Primary|Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12|Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
1281518|NCT00256750|Primary|Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.|Month 12; Month 3 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
1281519|NCT00256750|Primary|Percent of Participants Surviving With a Functioning Graft by Month 12|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
1281520|NCT00256724|Secondary|Quantity of Fluid Administration||during 10 minutes of device use||||mL||Standard Deviation|Mean
1281521|NCT00256724|Primary|Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline||every 2 minutes during 10 minutes of device use||||mm Hg||Standard Deviation|Mean
1281522|NCT00256698|Secondary|Overall Survival (OS)|Overall survival is equivalent to time to death. Time from randomisation until the date of death|All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.||||months||Full Range|Median
1281523|NCT00256698|Secondary|Time to Treatment Failure (TTF)|Time from randomisation until the date of discontinuation of randomised treatment for any reason|From randomisation until data cut-off on 30th April 2009||||months||Full Range|Median
1281524|NCT00256698|Secondary|Duration of Clinical Benefit (DoCB)|Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||months||Full Range|Median
1281525|NCT00256698|Secondary|Duration of Response (DoR)|Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||months||Full Range|Median
1281526|NCT00256698|Secondary|Percentage of Clinical Benefit Rate (CBR) Responders|No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||Percentage of participants|||Number
1281527|NCT00256698|Secondary|Percentage of Evaluable Participants With Objective Response Rate (ORR)|No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||Percentage of evaluable participants|||Number
1281528|NCT00256698|Primary|Time to Progression (TTP)|"RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve respond, stay the same stableor worsen progression during treatments."|RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||months||Full Range|Median
1281531|NCT00256308|Secondary|Disease-free Survival Rate|"Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.~Progression-free survival: from date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration~Progression: Appearance of any new lesion/site. The site of the new lesion will be recorded. Death due to disease without prior documentation of progression and without symptomatic deterioration Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Efforts should be made to obtain objective evidence of progression after discontinuation"|2 years|4 participants completed survival follow-up. 1 patient had progressive disease and stopped study drug, discovered during follow-up that patient had expired in hospice care. 1 patient completed study treatment but expired in follow up due to staph infection and complications from disease in hospice care.|||Participants|||Count of Participants
1281532|NCT00256308|Secondary|Locoregional Control Rate|Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.|2 years|Study was terminated by funding source for slow accrual. Upon termination notification, all research procedures stopped, inclusive of completing any analysis of data collected. Specific information about collection of data could not be located.||||||
1281533|NCT00256308|Primary|Frequency and Severity of Toxicities|Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.|2 years|Although data were collected, events were not analyzed at the time of collection for relatedness to treatment and this analysis cannot be performed retrospectively due to lack of access to complete patient records.||||||
1281534|NCT00256295|Secondary|Overall Survival and Time to Treatment Failure||5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.||||||
1281535|NCT00256295|Secondary|Frequency and Severity of Toxicities||5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.||||||
1281536|NCT00256295|Primary|Overall Response Rate (Complete and Partial Response)|"Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same techniques as baseline.~Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline."|5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.||||||
1281537|NCT00256282|Secondary|Percentage of Patients Alive at One Year||1 year||||Participants|||Count of Participants
1281538|NCT00256282|Primary|Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy|The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan.|Six months from initial treatment||||days||95% Confidence Interval|Median
1281539|NCT00256243|Secondary|Microscopic Pathological Response Rate|pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.|5 years|Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.|||Participants|||Count of Participants
1281540|NCT00256243|Primary|Clinical Response Rate|Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d’orange.|5 years|Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.|||Participants|||Count of Participants
1281541|NCT00256204|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase|Subjects were assessed according to the United Parkinson's Disease Rating Scale UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.|36 weeks||||Scores on a scale||Standard Deviation|Mean
1281542|NCT00256204|Primary|Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline|The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.|12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w||||Scores on a scale||Standard Deviation|Mean
1281543|NCT00256126|Secondary|Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1||Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||Units per liter (U/L)||Standard Deviation|Mean
1281544|NCT00256126|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1|HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.|Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||picomole per liter *millimole per liter||Standard Deviation|Mean
1281548|NCT00256126|Primary|Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1|IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing.|Baseline, Month 1|The Intention to Treat (ITT) population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||Standard deviation score (SDS)||Standard Deviation|Mean
1281549|NCT00255970|Secondary|Mobility Index|"Tooth mobility was recorded using Miller's Index:~— up to 1 mm of movement in a horizontal direction~— greater than 1 mm of movement in a horizontal direction~— excessive horizontal movement and vertical movement. Manual evaluation of mobility was carried out clinically using the handles of two instruments to move the teeth buccally and lingually and note their movement."|6 months|A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study. The power analysis had been computed for a threshold of 0.05 with a power of 0.8.|||Units on a scale||Standard Deviation|Mean
1281550|NCT00255970|Secondary|Bleeding on Probing|"The variable measured the presence of bleeding when the osseus defect was probed. The presence and character of gingival bleeding will be determined by gently probing to the base of the pockets.~0 - No bleeding.~1 - Bleeding when probing."|6 months|The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).|||Units on a scale||Standard Deviation|Mean
1281551|NCT00255970|Secondary|Plaque Index|"0- No plaque~A film of plaque adhering to gingival margin & adjacent area of tooth~Moderate accumulation of soft deposits, visible with the naked eye~Abundance of soft matter Each gingival region of the individual tooth will be scored 0-3 The scores from the 6 areas of the tooth are averaged to give the plaque index for the tooth."|6 months|The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm|||Categorical index score||Standard Deviation|Mean
1281552|NCT00255970|Secondary|Gingival Index|"Scores:~0 Normal gingiva~Mild inflammation~Moderate inflammation~Severe inflammation Gingival units (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of each tooth were scored 0-3. Scores from the 6 areas of the tooth were added and divided by 6 to give the gingival index for the entire tooth."|6 months|As stated in the protocol, the power analysis (threshold=0.05, power>0.8) noted 18 subjects would be needed per group.|||Units on a scale||Standard Deviation|Mean
1281553|NCT00255970|Primary|Recession|CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.|6 months|The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm|||mm||Standard Deviation|Mean
1281554|NCT00255970|Primary|Clinical Attachment Level|The amount of space between attached periodontal tissues and a fixed point, usually the cementoenamel junction. A measurement used to assess the stability of attachment as part of a periodontal maintenance program.|6 months||||mm||Standard Deviation|Mean
1281555|NCT00255970|Primary|Change in Probing Depth|This is the distance, measured in millimeters (mm) from the gingival margin to the maximal penetration of the probe tip. The measures were made at baseline and then at 6 months after treatment.|baseline and then at 6 months||||mm||Standard Deviation|Mean
1281556|NCT00255840|Primary|Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).|Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.|96 weeks|The primary analysis was an intention-to-treat analysis of any treatment failure with use of Cox proportional hazards regression.|||Percentage of participants||95% Confidence Interval|Number
1281557|NCT00255840|Secondary|To Estimate the Total and Incremental Costs, From the Provider and Societal Perspectives, of the Two Approaches (the Primary Health Care Sister and Doctor) to the Provision of Antiretrovirals in Primary Health Care Services in Each Study Site.||Throughout study|||||||
1281558|NCT00255840|Secondary|To Compare the Overall Clinical Safety of Antiretroviral Therapy, as Measured by the Occurrence of Clinical and Laboratory Grade 3 and 4 Adverse Events, Between Primary Health Care Monitoring Arms.||Throughout study|||||||
1281559|NCT00255840|Secondary|Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure||Throughout the study|||||||
1281560|NCT00255840|Secondary|To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.||Throughout study|||||||
1281561|NCT00255801|Secondary|Maximum Therapeutic Response|"CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT~CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment.~CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome.~Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) [12, 13]; the Composite Assessment of Index Lesion Severity (CA) [9, 14] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease"|2 years||||Participants|||Count of Participants
1281575|NCT00255190|Secondary|Mean Change From Baseline to Month 6 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 6|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1281562|NCT00255801|Primary|Median Progression-free Survival|"CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT~CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment.~CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome.~Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) [12, 13]; the Composite Assessment of Index Lesion Severity (CA) [9, 14] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease"|3 years||||months||Full Range|Median
1281563|NCT00255723|Primary|Overall Objective Response|"Overall objective response to therapy Complete remission/unconfirmed (CRu)~This includes patients who meet criteria for CR with the following exceptions:~1. A residual lymph node mass > 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR)~Any decrease in lymph nodes and nodal-based masses~Any decrease in PET avidity (however, residual FDG uptake is present)~Involving organs involved prior to therapy must have diminished in size.~No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease~1. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy"|3 years||||participants|||Number
1281564|NCT00255684|Secondary|Number of Participants Who Developed Acute Graft Versus Host Disease||3 months||||participants|||Number
1281565|NCT00255684|Primary|Number of Participants Who Survived 100 Days or Longer||100 days||||participants|||Number
1281566|NCT00255190|Primary|Changes From Baseline to Final Visit in Fundus Biopsy Results|Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.|Baseline and Final Visit (up to 12 months)|All subjects with Final Visit fundus biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days postdosing.|||subjects|||Number
1281567|NCT00255190|Primary|Changes From Baseline to Final Visit in Antrum Biopsy Results|Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.|Baseline and Final Visit (up to 12 months)|All subjects with Final Visit antrum biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days post-dosing.|||subjects|||Number
1281568|NCT00255190|Secondary|Mean Change From Baseline to Month 12 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 12|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1281569|NCT00255190|Secondary|Mean Change From Baseline to Month 9 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 9|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1281570|NCT00255190|Secondary|Mean Change From Baseline to Month 6 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 6|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1281571|NCT00255190|Secondary|Mean Change From Baseline to Month 3 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 3|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1281572|NCT00255190|Secondary|Mean Change From Baseline to Month 1 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 1|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1281573|NCT00255190|Secondary|Mean Change From Baseline to Month 12 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 12|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1281574|NCT00255190|Secondary|Mean Change From Baseline to Month 9 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 9|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1282017|NCT00249249|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change in total cholesterol from baseline to Week 12|Baseline to 12 Weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||percent change||Standard Deviation|Mean
1281578|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Systolic Blood Pressure||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mm Hg||Standard Deviation|Mean
1281579|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Serum Gastrin Levels||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||pg/mL||Standard Deviation|Mean
1281580|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||U/L||Standard Deviation|Mean
1281581|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||U/L||Standard Deviation|Mean
1281582|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||U/L||Standard Deviation|Mean
1281583|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Total Bilirubin Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
1281584|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
1281585|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Calcium Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
1281586|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Creatinine Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
1281587|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
1281588|NCT00255190|Primary|Mean Change From Baseline to Month 12 for White Blood Cell Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||White Blood Cell count x10 to the 3/mcL||Standard Deviation|Mean
1281589|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Platelet Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||Platelet Count x10 to the 3/mcL||Standard Deviation|Mean
1281590|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||g/dL||Standard Deviation|Mean
1281591|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Red Blood Cell Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||Red Blood Cell count x10 to the 6/μL||Standard Deviation|Mean
1281592|NCT00255190|Secondary|Mean Change From Baseline to Month 3 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 3|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
1281593|NCT00255190|Secondary|Mean Change From Baseline to Month 1 for PAGI-QOL Total Score|Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 1|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the Patient Assessment of Upper Gastrointestinal Disorders (PAGI) analyses.|||score on a scale||Standard Deviation|Mean
1281594|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Hematocrit Values|Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.|Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||percentage||Standard Deviation|Mean
1281595|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Hemoglobin Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||g/dL||Standard Deviation|Mean
1281596|NCT00255177|Primary|Mean Log Change in Viral Load From Baseline (Day 1) to Day 28|Mean log change in HCV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint|Baseline (Day 1) to Day 28||||copies/mL on log scale||Standard Deviation|Log Mean
1281597|NCT00255164|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
1281598|NCT00255164|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
1281599|NCT00255164|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.|||Percentage of Subjects|||Number
1281600|NCT00255164|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
1281601|NCT00255164|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
1281602|NCT00255164|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.|||Percentage of Subjects|||Number
1281603|NCT00255151|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
1281604|NCT00255151|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
1281605|NCT00255151|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.|||Percentage of Subjects|||Number
1281606|NCT00255151|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
1281607|NCT00255151|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
1281608|NCT00255151|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.|||Percentage of Subjects|||Number
1281609|NCT00255125|Secondary|Molecular Effects of Soy Supplementation Compared to Placebo.|Using a tissue microarray targeting the cell cycle, selected fresh prostate cancer samples were evaluated in patients in the soy supplement arm compared to the placebo arm.|One year|||||||
1281610|NCT00255125|Secondary|2.Effect of Soy Isoflavones on Estrogen Receptor Status.|Samples of the prostate cancer tissue (paraffin embedded) were sectioned and placed on a glass slide. Using immunohistochemistry and an estrogen receptor antibody, sections were stained and assess to determine the extent of estrogen receptor expression. Patients in the soy supplement arm's samples results were compared to placebo arm results.|One year|||||||
1281611|NCT00255125|Primary|1.Effect of Soy Isoflavones on Serum Testosterone Levels.|Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.|Two weeks||||ng/ml||80% Confidence Interval|Mean
1281612|NCT00255086|Secondary|Mean Change on the ADAS-Cog Score After 1 Year|Progression of cognitive functioning as measured by performance on the Alzheimer's Disease (AD) Assessment Scale-cognitive subscale (ADAS-Cog). ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics, and measures disturbances of of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Responses are summed for an overall score which can range from 0-70. The greater the dysfunction, the higher the score. A typical score for a person without dementia is 5.|Baseline; Year 1|Participants who could tolerate study medication and who completed the study were included in the analysis.|||units on a scale||Standard Deviation|Mean
1281613|NCT00255086|Primary|NAA/Cr Ratio|To determine if memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of hippocampal n-acetyl aspartate (NAA) and magnetic resonance imaging volumetric measures (MRI) of hippocampal volume.|Baseline; Year 1|Participants who could tolerate study medication and who completed the study were included in the analysis.|||Ratio||Standard Deviation|Mean
1281614|NCT00255047|Primary|Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.||30 Days post-dose 3 vaccination.|Geometric mean titers were evaluated in the per-protocol immunogenicity population|||Titers||95% Confidence Interval|Geometric Mean
1281615|NCT00255047|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3|Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.|7 days post-vaccination 3|Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population|||Participants|||Number
1281616|NCT00255047|Primary|Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)||30 Days post-dose 3 vaccination|Four-fold rise titers (seroconversion) were evaluated in the per-protocol population|||Percentage of participants|||Number
1281617|NCT00255047|Primary|Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.|Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.|30 Days post-dose 3 vaccination|The vaccine response to pertussis antigens were determined in the per-protocol population.|||Percentage of Participants|||Number
1281618|NCT00255034|Primary|Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy|No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.|24 weeks after completion of either up to 24 or 48 weeks of therapy|"Data were missing for 1 subject in the 48 weeks of therapy treatment arm."|||Participants|||Number
1281619|NCT00255008|Primary|Number of Subjects Who Achieved a Sustained Virologic Response (SVR)|SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.|24 weeks after completion of either up to 24 or 48 weeks of therapy|The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution. No data was available at 24 weeks after therapy for the Genotype 1 Caucasian treatment group.|||Participants|||Number
1281620|NCT00254995|Other Pre-specified|Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination|Only persons who received Menactra vaccine during the study period were included in this outcome.|Day 0 up to Determination of Pregnancy Outcome|Only persons who received Menactra vaccine during the study period were included in the analysis. There were no control group analysis because the threshold of 25 pregnancies with known were not achieved at the time the surveillance was concluded.|||Paticipants|||Number
1281621|NCT00254995|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination – Hospital Setting – All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 doses|||Number
1281622|NCT00254995|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination – ER Setting – All Ages Combined.|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only all persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 doses|||Number
1281623|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – By Age Categories – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1281845|NCT00251589|Secondary|Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)|First documentation of Progressive Disease (PD) occurring > 8 weeks on study.|Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Disease Progression After Week 8.|||Participants|||Number
1281624|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – All Ages Combined – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1281625|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – By Age Categories – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine and their age-matched controls during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1281626|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons – By Age Categories – Short-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 60 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1281627|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – All Ages Combined – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1281628|NCT00254995|Primary|Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined – Short-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 60 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1281629|NCT00254982|Primary|Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score|PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).|Baseline and Week 22|Per Protocol Population - All participants in the intent to treat population who completed the study without major protocol violations. For missing data, the last observation carried forward (LOCF) was applied.|||Proportion of participants|||Number
1281630|NCT00254592|Primary|Overall Clinical Response to the Dose Dense Regimen|Measure clinical response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2- 4 cycles of biweekly doxorubicin, cyclophosphamide with GMCSF (day 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).|3 years||||Participants|||Count of Participants
1281631|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score|1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF-missing values at TOC will be imputed by carrying forward the last post-baseline observation; Domain score is calculated by deriving the simple average of the relevant items, both mental state items must be non-missing to derive a mental state score|||Score on Scale||Standard Error|Least Squares Mean
1281665|NCT00254410|Secondary|Molecular Response Rate at 3 Months|Molecular response rate (PCR for immunoglobulin heavy chain (IgH) rearrangements) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.|End of cycle 3||||Participants|||Count of Participants
1281632|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score|1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF-missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score|||Score on Scale||Standard Error|Least Squares Mean
1281633|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score|1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale – 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF - missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score|||Score on Scale||Standard Error|Least Squares Mean
1281634|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score|CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, Last Observation Carried Forward (LOCF)-missing values at TOC visit will be imputed by carrying forward the last post-baseline observation; total score calculated by deriving the simple average of relevant items, total score is set to missing if 1 or more domain scales cannot be derived.|||Score on Scale||Standard Error|Least Squares Mean
1281635|NCT00254566|Secondary|Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence|Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.|Number of Days|Time to AECB recurrence will be analyzed for the FAS using survival analysis methods to account for censored observations. Subjects are censored at the date last known to have not experienced a recurrence. Median time to recurrence will be estimated using the Kaplan-Meier method.|||Days|||Number
1281636|NCT00254566|Secondary|Percentage of Bacteriologic Response at Test of Cure Visit|Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline|Test of Cure (TOC) Visit (Day 12-19)|Bacteriologic per protocol set is compromised of subjects from the Clinical Per Protocol set with a baseline bacterial pathogen. The number of participants is the number of unique pathogens identified at baseline.|||Percent|||Number
1281637|NCT00254566|Secondary|Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)|Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Clinically eligible compromised of subjects from FAS with diagnosis of chronic bronchitis, clinical evidence of AECB based on S&S, & a neg chest radiograph for pneumonia based on radiologist opinion|||Percent|||Number
1281638|NCT00254566|Secondary|Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)|Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Full Analysis Set (FAS) is all randomized subjects who received at least 1 dose of study medication.|||Percent|||Number
1281639|NCT00254566|Primary|Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)|Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Clinical Per Protocol-all randomized subjects who were clinically eligible; received at least 80% of study med; no concomitant systemic antibiotics with activity against Acute Exacerbation of Chronic Bronchitis (AECB) pathogens, assessment made in appropriate visit window.|||percent|||Number
1281640|NCT00254540|Secondary|Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis.~n=Number of subjects with analyzable data."|||pg/mL||Full Range|Median
1281641|NCT00254540|Secondary|Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)|Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis.~n=Number of subjects with analyzable data."|||pg/mL||Full Range|Median
1281663|NCT00254462|Primary|Change in ADHD-IV Rating Scale Total Score|"Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.~The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27."|Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.||||units on a scale||Standard Error|Mean
1281642|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population|"SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject."|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
1281643|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population|"SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject."|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
1281644|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population|SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
1281645|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population|SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
1281646|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3."|||ng/mL||Full Range|Median
1281647|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
1281648|NCT00254540|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)|"Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline.~The VAS is a self-completed scale designed to rate the subject’s current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n=Number of subjects with analyzable data."|||Scores on a scale||Standard Deviation|Mean
1281649|NCT00254540|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score|Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale (1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index (Range: 0 to 1). High score is indicating high health.|Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n=Number of subjects with analyzable data."|||Scores on a scale||Standard Deviation|Mean
1281650|NCT00254540|Secondary|Overall Survival Time|Overall survival time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, overall survival time was censored on the last date when the subject was known to be alive.|once year. Up to 3 years after the completion of subject registration.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||Full Range|Median
1281651|NCT00254540|Secondary|Time to Tumor Response (TTR)|Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.|Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.|||Weeks||Full Range|Median
1281664|NCT00254410|Secondary|Molecular Response Rate at 6 Months|Molecular response rate (PCR for IgH rearrangements) at 6 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.|End of 6 months||||Participants|||Count of Participants
1282018|NCT00249249|Primary|Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12||Baseline to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||percent change||Standard Deviation|Mean
1281652|NCT00254540|Secondary|Duration of Response (DR)|Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.|||Weeks||Full Range|Median
1281653|NCT00254540|Secondary|Time To Tumor Progression (TTP)|Time to tumor progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD).|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||Full Range|Median
1281654|NCT00254540|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||Full Range|Median
1281655|NCT00254540|Primary|Number of Subjects With Objective Response|Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||participants|||Number
1281656|NCT00254501|Secondary|Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months|"Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):~Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment~Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers.~Changes from baseline to 12 months for understanding of diabetes. This is a single question: How would you rate your understanding of diabetes and its treatment? which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent)."|From baseline to 12 months|The number of participants reported for each outcome reflects those participants who completed both baseline and 12-month surveys.|||units on a scale||95% Confidence Interval|Mean
1281657|NCT00254501|Secondary|Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months|"Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:~Total cost of care~Costs of diabetes medications~Costs of diabetes supplies"|baseline to 12 months|Changes in claims-based data from baseline to 12 months among patients with at least one diabetes-related claim at baseline.|||US dollars||95% Confidence Interval|Mean
1281658|NCT00254501|Secondary|Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides|"Changes from baseline in LDL, HDL, total cholesterol, triglycerides.~Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):~LDL~HDL~Total cholesterol~Triglycerides"|baseline and 12 months|The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.|||mg/dl||95% Confidence Interval|Mean
1281659|NCT00254501|Primary|Change in Hemoglobin A-1C From Baseline|Compare changes in Hemoglobin A-1C from baseline between the two groups.|baseline and 12 months|Specific employers were recruited and offered waiver of out-of-pocket costs for diabetes-related care to their employees to participate in the study. The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.|||percentage of glycolsylated hemoglobin||Standard Deviation|Mean
1281660|NCT00254488|Primary|Young Mania Rating Scale (YMRS) Scores|The Young Mania Rating Scale is an eleven item interviewer-rated instrument. Four items are scored 0-8, the others 0-4. The total score therefore ranges from 0-60, with higher values reflecting greater severity.|Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9|The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.|||units on a scale||Standard Deviation|Mean
1281661|NCT00254488|Primary|Sedation Score|The Sedation Item score of the UKU (Norwegian for Committee of Clinical Investigations) Side Effect Rating Scale. A higher value indicates greater severity. Range is 0-3 (not present, mild, moderate, or severe).|Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9|The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.|||units on a scale||Standard Deviation|Mean
1281662|NCT00254462|Secondary|Change in Total ADHD-IV Teacher|Measures 18 symptoms of ADHD. Each symptom rated 0-3, for a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.|Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.||||units on a scale||Standard Error|Mean
1281780|NCT00252174|Secondary|Beck Hopelessness Scale (BHI)|Established self-report measure of depression and hopelessness, consisting of 20 true-false questions, with scores ranging from 0 to 20, with scores of 0-3 indicating minimal hopelessness and scores of 15-20 severe hopelessness.|Obtained over 3 months of study|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281666|NCT00254410|Primary|Clinical Response Rate at 6 Months|Clinical Response Rate (combined morphological [NCI WG criteria] + flow cytometry criteria) at 6 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.|End of Cycle 6||||Participants|||Count of Participants
1281667|NCT00254410|Primary|Clinical Response Rate at 3 Months|Clinical Response Rate (combined morphological [NCI Working Group (WG) criteria] + flow cytometry criteria) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.|End of cycle 3||||Participants|||Count of Participants
1281668|NCT00254293|Secondary|Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies|Assessment of positive antibody response based upon analysis using a validated enzyme-linked immunosorbent assay (ELISA) with a cut-off value. CTLA4 is a protein receptor that downregulates the immune system. Short Term (ST) period was initial 12 Weeks of the study. Overall LTE includes both the variable and fixed abatacept dosing periods and was from the end of the ST period (Day 85) up to 168 days post last dose (treatment in LTE ranged from 4.4 to 74.2 months. Data in the ST period are summarized by the treatment the participants actually received, while the LT period data are summarized by treatment the participant was randomized to receive.|ST: Day 1 to Day 85; LTE: Day 85 to 168 days post last dose|In the ST period, only subjects treated with abatacept (51) were evaluated for antibodies. In LTE, 61 participants were analyzed for anti-abatacept antibodies, and 62 participants were analyzed for CTLA4-T antibodies. Participants were analyzed during treatment and post-treatment (28, 56, 85, and 168 days post-treatment).|||participants|||Number
1281669|NCT00254293|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)|On Day 85 participants rolled over into the LTE with variable dose phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight. This summary includes AEs reported during entire LTE treatment plus 56 days post last dose; includes all deaths reported during the LTE including those that occurred greater than 56 days after last dose. MedDRA version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 533 to 56 Days Post last dose|total number of participants in the Long Term Extension Period.|||participants|||Number
1281670|NCT00254293|Secondary|Short Term Period: Mean Change From Screening at Day 85 in ECG (Heart Rate) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. Heart Rate was reported in beats per minute (bpm). In no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Screening to Day 85 (or early termination)|A total of 68 participants were treated with abatacept or placebo: 65 had results at screening and 53 had results at Discharge (Day 85) for Heart Rate.|||bpm||Standard Deviation|Mean
1281671|NCT00254293|Primary|Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)|LTE period with variable abatacept dosing starting on Day 85 and continuing until Day 533 when LTE fixed dosing started. AEs of special interest: infection and/or infestation; neoplasms (malignant); pre-specified autoimmune disorder; infusional AEs (peri-infusional: pre-specified AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: pre-specified AEs occurring during the first hour after the start of the IV loading dose; systemic injection site reactions (SIR): pre-specified AEs for SIR; local injection site reaction: pre-specified AEs for local site reaction. Data are presented by treatment the participant was randomized to and not what they actually received.|Day 85 to Day 533|All 63 participants who completed the ST period enrolled into the LTE variable dosing period and were analyzed.|||participants|||Number
1281672|NCT00254293|Secondary|Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. QT interval, PR interval and QRW Width were reported in milliseconds (msec). If no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Screening to Day 85 (or early termination)|A total of 68 participants were treated with abatacept or placebo: 66 had results at screening and 52 had results at Discharge (Day 85) for QT interval and QRS Width; 65 and 51 participants had PR interval results at Screening and Discharge (Day 85), respectively.|||msec||Standard Deviation|Mean
1281706|NCT00253643|Primary|Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention|Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.|End of study|Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.|||%age of cells & nuclei stained||Full Range|Median
1281673|NCT00254293|Secondary|Short Term Period: Mean Change From Baseline at Day 85 in Pulse Rate After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|Pulse rate was taken while participant was seated. Pulse rate was recorded during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, vital signs were recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Pulse rate measured in beats/min (bpm). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28, 6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively|||bpm||Standard Deviation|Mean
1281674|NCT00254293|Secondary|Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|Blood pressure (systolic and diastolic) was recorded while the participant was seated during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, blood pressure was recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Blood pressure was measured in millimeters of mercury (mm Hg). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28,6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively|||mm Hg||Standard Deviation|Mean
1281675|NCT00254293|Secondary|Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85|Screening, BL, Days 15, 29, 57, 85 or discharge. Upper limit of normal (ULN). CTC grade (Gr): Alanine transaminase Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase Gr 1: >ULN to 2.5*ULN; Gr 2:>2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. G-Glutamyl Transferase (U/L) Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Alkaline phosphatase (U/L) Gr 1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4: >20.0*ULN; creatinine (mg/dL) Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 6.0*ULN; Gr 4: >10.0*ULN. Albumin (g/dL) Gr 1:<LLN to 3.0; Gr 2:<3.0 to 2.0; Gr 3: <2.0. Uric Acid (mg/dL)Gr 1: >1.0 x ULN to 10.0; Gr 4: >10.0. Sodium (mEq/L) Gr 1: >ULN to 150; Gr 2: >150 to 155; Gr 3: >155 to 160; Gr 4: > 160. Potassium (mEq/L) Gr 1: >ULN to 5.5; Gr 2: >5.5 to 6.0; Gr 3: >6.0 to 7.0; Gr 4: >7.0. Data presented by treatment participant actually received.|Day 1 to Day 85 (or early termination)|All participants treated with abatacept or placebo in the short term period. Participant is counted once in total but could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)|||participants|||Number
1281676|NCT00254293|Secondary|Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)|Blood samples were obtained: At screening, within 24 hours prior to study drug administration on Day 1, on Days 15, 29, 57 and at study discharge. Baseline (BL) defined as Day 1 prior to treatment. Common toxicity criteria (CTC), Version 3 used to assess parameters. lower limit of normal (LLN). ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Lymphocytes Gr 1: <LLN to 3.0, Gr 2: 2.0 < 3.0, Gr 3: 1.0 to < 2.0, Gr 4; < 1.0. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Hematocrit (%): <0.75*pre-treatment. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants treated with either abatacept or placebo. Participant counted once in total for each arm but participant could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)|||participants|||Number
1281677|NCT00254293|Secondary|Short Term Period: Mean Percent Change From Baseline on Day 85 in Participants Positive for Serum Rheumatoid Factor During Abatacept or Placebo Administration|Serum samples were obtained on Days 1, 8, 15, 29, 57 and day of discharge (Day 85 or earlier) for determination of presence of rheumatoid factor (RF). Baseline was defined as Day 1 to calculate percent change. Lower limit of quantitation (LLQ) was 5 Units/milliliter (U/mL). Values below LLQ were set to 2.5 U/mL. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|Analysis set included all available data from participants who received abatacept or placebo. For RF analysis in Group 1 Day 1/Day 85 number of participants = 7/7; Group 2 = 3/3; Group 3 = 29/29; Group 4 = 6/6; Group 5 = 5/5; Placebo = 17/15 participants.|||percentage of change from baseline||Standard Deviation|Mean
1281678|NCT00254293|Secondary|Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks|AEs of special interest: infection and/or infestation; neoplasms (benign, malignant, unspecified; autoimmune disorder; infusional AEs (peri-infusional: AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: AEs occurring during the first hour after the start of the IV loading dose; injection site AEs: AEs occurring at the site of the SC injection. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All subjects treated were analyzed for safety.|||participants|||Number
1281707|NCT00253643|Primary|Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)|Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.|Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)|Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.|||units on a scale||Standard Deviation|Mean
1281679|NCT00254293|Secondary|Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo|Number of Participants with Adverse events (AEs), Serious AEs, discontinuations due to AEs, or Deaths occurring while participant was on treatment from Day 1 (treatment) to Day 85 or early termination from the study. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)||||participants|||Number
1281680|NCT00254293|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)|AEs during variable dose phase of LTE + 56 days post last dose in the variable dose phase or start of the fixed dose phase, which ever came first; includes deaths reported during the variable dose phase including those that occurred greater than 56 days after last dose. Medical Dictionary for Regulatory Activities (MedDRA) version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug. Data presented by treatment the participant was randomized to and not what they actually received.|Day 85 to 56 days post last dose|Participants included those that rolled over into the LTE, receiving variable SC dosing of abatacept in the Variable Dose Period.|||participants|||Number
1281681|NCT00254293|Secondary|Short Term Period: Area Under the Curve (AUC) in Time Interval of 7 Days [AUC(TAU)] of Abatacept in Participants With Rheumatoid Arthritis Receiving DMARDS|The steady-state pharmacokinetic parameter AUC(TAU) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78 (TAU=7 days). Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001; Upper limit of quantification (ULOQ) was 0.030. AUC(TAU) measured in in micrograms*hours per milliliter (µg*h/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 71 to Day 78|Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1281682|NCT00254293|Secondary|Short Term Period: Peak Serum Concentration (Cmax) of Abatacept at Steady State in Participants With Rheumatoid Arthritis Receiving DMARDS|Peak serum concentration (Cmax) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78. Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001, Upper limit of quantification (ULOQ) was 0.030. Cmax measured in micrograms per milliliter(µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 71 to Day 78|Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1281683|NCT00254293|Primary|Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)|Participants received abatacept while also receiving DMARDS over a short term (ST) 12 Week period. To eliminate contribution from the IV loading dose of abatacept during the short term study period, Cmin values were selected from Days 71 to 85, when contribution from IV was negligible. Minimum trough serum concentration of abatacept (Cmin) was measured in micrograms/milliliter (µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Days 71 to 85|50 of the 51 abatacept-treated subjects were included. One subject who discontinued after receiving only Day 1 dosing was not included in this analysis.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1281684|NCT00254163|Secondary|Progression-free Survival (PFS) Rate at 2-year|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|24 months after registered.|Per protocol population|||Probability of Progression-free Survival||95% Confidence Interval|Number
1281685|NCT00254163|Secondary|Progression-free Survival (PFS) Rate at 1-year|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date|12 months after registered.|Per protocol population|||probability of Progression-free Survival||95% Confidence Interval|Number
1281686|NCT00254163|Secondary|Objective Remission Rate (ORR)|"Complete remission (CR) see Outcome Measure 6. Partial remission (PR) must exhibit criteria 1 and 2 as well as one or more of the remaining features for at least 2 months.~≥50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value.~≥50% reduction in lymphadenopathy.~≥50% reduction in the size of the liver and/or spleen.~Polymorphonuclear leukocytes ≥ 1,500/mm^3 or 50% improvement over baseline.~Platelets >100,000/mm^3 or 50% improvement over baseline.~Hemoglobin >11.0 g/dL or 50% improvement over baseline without transfusions. Nodular partial remission (nPR) is defined as a CR with persistent bone marrow nodules; Objective Remission (OR) = CR + PR + nPR."|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of participants||95% Confidence Interval|Number
1281708|NCT00253630|Secondary|2-Year Progression Free-Survival|Estimated using the product-limit method of Kaplan and Meier. Progression defined as any new lesion or increase by greater than 50% of previously involved sites from nadir.|Until death or progression, up to 2 years||||percentage of participants||95% Confidence Interval|Number
1281709|NCT00253630|Secondary|2-Year Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until Death from any cause, up to 2 years||||percentage of participants||95% Confidence Interval|Number
1281687|NCT00254163|Secondary|Complete Remission (CR)|"Definitions of response is evaluated using guidelines proposed by the National Cancer Institute-Sponsored Working Group for Chronic Lymphocytic Leukemia.~Complete remission (CR) requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must be <1 cm.~No evidence of hepatomegaly or splenomegaly.~Absence of constitutional symptoms.~Normal CBC as exhibited by:~Polymorphonuclear leukocytes ≥ 1,500/mm^3~Platelets > 100,000/mm^3~Hemoglobin > 11.0 g/dL (untransfused)~Bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results demonstrate that all of the requirements listed in 1-4 have been met to demonstrate that a CR has been achieved. The marrow sample must be at least normocellular for age, with less than 30% of the nucleated cells being lymphocytes.~Lymphoid nodules should be absent."|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of participants||95% Confidence Interval|Number
1281688|NCT00254163|Secondary|Mean Absolute Neutrophil Count (ANC) at Post-treatment|mean Absolute Neutrophil Count (ANC) measured 2 months (8-10 weeks) following the last dose of study treatment|2 months post-treatment|Per protocol population|||10^3 cells/mm^3||Standard Deviation|Mean
1281689|NCT00254163|Secondary|Hematologic Recovery|defined as Hb >11g/dL and a platelet count >100 × 10^3/mm^3|2 months post-treatment|Per protocol population|||percentage of participants||95% Confidence Interval|Number
1281690|NCT00254163|Secondary|Percentage of Patients Hospitalized|Percentage of patients who were hospitalized due to any reasons during the study period.|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of participants|||Number
1281691|NCT00254163|Secondary|Infective Event Rate|infective events=temperature >101 without symptoms or temp <101 with symptoms|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of infective events|||Number
1281692|NCT00254163|Primary|Infection Rate|infection=febrile events requiring treatment|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of participants||95% Confidence Interval|Number
1281693|NCT00254072|Primary|Number of Participants With Postoperative Gastrointestinal Hemorrhage||30 days||||participants|||Number
1281694|NCT00253981|Primary|Visual Analog Scale|Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.|4 weeks|||||||
1281695|NCT00253890|Primary|Sleep Quality, as Measured by Total Sleep Time|Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.|Baseline to 1-month|Intent to Treat|||minutes||Standard Deviation|Mean
1281696|NCT00253747|Secondary|Point-prevalence Abstinence|A logistic regression including site and treatment group will be used to model rates of achieving point prevalence abstinence as assessed at the final visit of the O-MPH/P-Stnd Smoking Tx phase. Point prevalence abstinence was defined as not smoking in the previous seven days based on self-report using the TLFB method and confirmed with a Carbon Monoxide (CO) level <8 ppm.|Week 11|Evaluable population determined as for primary outcome.|||participants|||Number
1281697|NCT00253747|Secondary|Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale|A Generalized Estimating Equations(GEE)model which included treatment group, week, site, and treatment by week and site by week interaction effects was used to compare the groups on the DSM-IV ADHD total severity score (18 domains score at severity levels of 0[none]-3[severe]; maximum score 54) as measured at screening/baseline and study weeks 1-4 using the the interviewer-administered DSM-IV checklist and by the severity portion of the National Institute of Mental Health Clinical Global Impression (CGI) scale to rate the severity of the participant’s ADHD symptoms. A single severity score ranging from 1 to 7 is yielded by the CGI severity scale.|Baseline and Study weeks 1,4,7,9,11|Evaluable participants determined using criteria for same in the primary outcome.|||DSM IV ADHD Score||Standard Deviation|Mean
1281698|NCT00253747|Primary|Prolonged Abstinence|The smoking quit date was considered the first day of the O-MPH/P-Stnd Smoking Tx phase, which lasted for 6 weeks or more precisely 42 days (i.e., approximately weeks 5-10). The grace period was the first two weeks (i.e., days 1-14) with the remaining four weeks (days 15-42) comprising the period in which the participant must not meet criteria for treatment failure in order to be scored as obtaining prolonged abstinence. Self-report of cigarette use was assessed using a time-line follow-back (TLFB) assessment using carbon monoxide (CO)levels to correct self-reported smoking days. “Smoking days” were determined by starting with self-reported smoking and non-smoking days and using CO levels measured at weekly visits to modify the self-reports.|Weeks 7-10|Randomized participants who complete at least two visits during the first four weeks following randomization, who reach the full dose of OROS-MPH /Placebo, who have a OROS-MPH /placebo medication compliance rate of at least 75% each week for study weeks 4 through 10, and who attend at least one meeting after initiating the nicotine patch.|||participants|||Number
1281699|NCT00253708|Secondary|Sleep|Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
1281700|NCT00253708|Secondary|Quality of Life: McGill Total|Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
1281701|NCT00253708|Secondary|Quality of Life: Psychological Well-being|Psychological well-being over past 2 days (depressed, nervous/worried, sad, terrified of future) (0= always/extremely to 10= never/not at all; in other words: 0=negative/worst to 10= positive/best)|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
1281702|NCT00253708|Secondary|Quality of Life: Physical Well-being|Physical well-being over past 2 days (0= physically terrible to 10= physically well)|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
1281703|NCT00253708|Primary|Alertness|0=not at all alert to 10=most alert|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
1281704|NCT00253708|Primary|Anxiety|0=no anxiety to 10=most severe anxiety|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
1281705|NCT00253708|Primary|Pain|0=no pain to 10=most severe pain|From baseline to 1 week and from baseline to one month||||units on a scale||Inter-Quartile Range|Median
1281710|NCT00253630|Secondary|Change in Histone Acetylation by Western Blot (WB)|Histone acetylation by WB will be recorded as the ratio of acetylated histone (measured by photodensitometry) divided by the total histone (H3 or H4), in order to control for the amount of protein loaded. Analysis will be descriptive, with the goal of describing baseline distributions and estimating the frequency and degree of changes from baseline.|Baseline to up to day 14|Western Blot data was not collected and is not available for analysis.||||||
1281711|NCT00253630|Secondary|Change in Histone Acetylation by Immunohistochemistry (IHC)|Histone acetylation by IHC will be scored as –, +, ++, or +++, reflecting both the intensity of staining as well as the number of cells stained. Analysis will be descriptive, with the goal of describing baseline distributions and estimating the frequency and degree of changes from baseline.|Baseline to up to day 14|Immunohistochemistry data was not collected and is not available for analysis.||||||
1281712|NCT00253630|Primary|Number of Participants With Adverse Events|Grades 3 & 4 adverse events definitely, probably or possibly related to treatment, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|Up to 3 years||||Participants|||Count of Participants
1281713|NCT00253630|Primary|Response Rate|Radiological assessment by CT and/or PET scan after every three cycles (every 3 months). Response assessed by the standard Cheson criteria (Cheson et al, J Clin Oncol 17:1244, 1999). Complete Remission (CR) - (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT; Partial Remission (PR) - 50% or greater decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. Response Rate = CR + PR.|Up to 3 years||||percentage of participants||95% Confidence Interval|Number
1281714|NCT00253513|Secondary|Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival.||One year||||participants|||Number
1281715|NCT00253513|Primary|Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only)|NRM (Non relapse mortality) - death not attributed to the primary cancer.|200 days||||percent of participants||95% Confidence Interval|Number
1281716|NCT00253513|Primary|Number of Patients Experiencing Graft Failure|Graft versus Host Disease (GVHD) is a frequent complication of allogeneic bone marrow transplant in which the engrafted donor cells attacks the patient's organs and tissue. Acute GVHD (aGVHD) usually occurs during the first three months following an allogeneic BMT. Chronic GVHD (cGVHD) usually develops after the third month post-transplant. Patients may experience one, both or neither.|42 days|For graft failure 2 of the 60 patients were not evaluable because they exeperienced another event (relapsed) before they could be evaluable for graft failure.|||participants|||Number
1281717|NCT00253513|Primary|Number of Patients Experiencing Regimen-related Toxicity Events in Study Population|Proportion of patients experiencing regimen-related toxicity to major organ systems from day minus 6 to day 28. Major organ systems: cardiac, bladder/renal, pulmonary, hepatic, neurologic and gastrointestinal|34 days and 2 years||||participants|||Number
1281718|NCT00253448|Primary|Overall Survival After Treatment|Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years|Minimum of 5 years.||||months||95% Confidence Interval|Median
1281719|NCT00253435|Secondary|Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS|"Dose limiting veno-occlusive disease (VOD) defined as:~the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin > grade 1, PLUS~the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution"|Between start of MIBG treatment and 60 days post stem cell infusion|All patients who began treatment|||participants|||Number
1281720|NCT00253435|Secondary|Engraftment DLT|"• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as:~neutrophils (ANC) < 500/μL by day 28 post transplant, or~platelets < 20,000 /μL by day 56 post transplant, or~if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets."|From treatment start until 60 days post stem cell infusion|All patients who began treatment|||participants|||Number
1281721|NCT00253435|Secondary|Event-free Survival (EFS) at 3 Years|EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.|3 years since start of treatment|Estimated probability of 3-year progression free survival for all patients enrolled in each risk group.|||Estimated probability|||Number
1281722|NCT00253435|Primary|Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion|Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).|Response assessed 60 days post stem cell infusion|One patient in the Poor Risk Cohort underwent surgery for resection (of his only measureable lesion) prior to post-treatment assessment and is not evaluable for response.|||participants|||Number
1281723|NCT00253370|Secondary|Overall Survival (OS)|Overall survival was defined as the time from registration to death from any cause.|Assessed every 3 months if patient is < 2 years from study entry; then every 6 months if patient is 2-3 years from study entry.|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.|||Months||90% Confidence Interval|Median
1281724|NCT00253370|Secondary|Progression-free Survival (PFS)|"Progression-free survival was defined as the shorter of:~The time from registration to progression. or~The time from registration to death without documentation of progression given that the death occurs within 4 months of the last disease assessment without progression (or registration, whichever is more recent).~Therefore, cases not meeting either of the criteria for a PFS event are censored at the date of last disease assessment without progression (or registration, whichever is more recent).~Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions."|Assessed every 6 weeks until disease progression or up to 3 years|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.|||Months||90% Confidence Interval|Median
1281725|NCT00253370|Primary|The Proportion of Patients With Objective Response (Complete Response or Partial Response)|Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed every 6 weeks until disease progression or up to 3 years|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.|||Proportion of patients||90% Confidence Interval|Number
1281726|NCT00253019|Primary|Continuation Rates|We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.|3 months|It was a convenience sample.|||participants|||Number
1281727|NCT00252967|Secondary|Comparison of Tumor Necrosis Factor Alpha Values||Baseline and 30 days||||ng/mL||Inter-Quartile Range|Median
1281728|NCT00252967|Secondary|Comparison of High Sensitivity C-reactive Protein||Baseline and 30 days||||mg/L||Inter-Quartile Range|Median
1281729|NCT00252967|Secondary|Comparison of Interleukin-1 Values||Baseline and 30 days||||ng/mL||Inter-Quartile Range|Median
1281730|NCT00252967|Secondary|Comparison of Interleukin-6 Values||Baseline and 30 days||||ng/mL||Inter-Quartile Range|Median
1281731|NCT00252967|Secondary|Comparison of Isoprostanes Values||Baseline and 30 days||||pg/mL||Inter-Quartile Range|Median
1281732|NCT00252967|Secondary|Comparison of Derivatives of Reactive Oxygen Metabolites Values||Baseline and 30 days||||Carr||Inter-Quartile Range|Median
1281733|NCT00252967|Secondary|Comparison of Redox Potential for Glutathione Values||Baseline and 30 days||||mV||Inter-Quartile Range|Median
1281734|NCT00252967|Secondary|Comparison of Redox Potential for Cysteine Values||Baseline and 30 days||||mV||Inter-Quartile Range|Median
1281735|NCT00252967|Primary|Time of Atrial Fibrillation Recurrence||Upon recurrence, up to 12 months||||days||Inter-Quartile Range|Median
1281736|NCT00252733|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||log (µg/min)/year||95% Confidence Interval|Least Squares Mean
1281737|NCT00252733|Primary|Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale.|Two steps were defined as either a 1-step change in each eye or as a 2-step change in one eye only. ETDRS is a scale with 11 steps (1-11, where a score of 1 represents no retinopathy and a score of 11 represents proliferative retinopathy). A generalized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
1281738|NCT00252720|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log (UAER) over time (post-randimisation, yearly assessments) for each patient|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randimized patients with any post-randomization data.|||log (µg/min)/year||95% Confidence Interval|Least Squares Mean
1281739|NCT00252720|Secondary|Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).|Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population whick includes all randomized patients with any post-randomization data.|||Participants|||Number
1281740|NCT00252720|Secondary|Number of Participants With a Regression of Diabetic Retinopathy.|Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).|From baseline to the end of the study, i.e., 5 years|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
1281741|NCT00252720|Primary|Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale|Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention to Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
1281742|NCT00252694|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.|From Baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||log (µg/min)/1000 year||95% Confidence Interval|Least Squares Mean
1281743|NCT00252694|Secondary|Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).|Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
1281744|NCT00252694|Secondary|Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.|3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
1281745|NCT00252694|Primary|Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale|3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
1281746|NCT00252629|Primary|The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.|"IFL was determined by plotting inspiratory flow against supra-glottic pressure for each breath sampled during continuous stage 2 sleep on a full night polysomnogram on both veterans with GWS and asymptomatic gulf war veterans.~We expressed the prevalence of inspiratory flow limitations during sleep as the percentage of flow limited breath in the sample of both GWS and asymptomatic gulf was veterans."|On a full night polysomnogram||||percentage of flow limited breaths||Standard Deviation|Mean
1281747|NCT00252629|Secondary|Change of Cognitive Dysfunction|Cognition dysfunction- increasing difficulty with memory, ability to think, and ability to concentrate was rated 0-10 daily by visual analogue scale, where 0 no problem and 10=severe problems.|3 weeks treatment with either therapeutic or sham CPAP||||units on a scale||Standard Deviation|Mean
1281748|NCT00252629|Secondary|Change of Pain Complaint|"Pain- increased level were rated 0-10 by visual analogue scale, where 0= no pain and 10= severe pain.~We compared the change of pain symptom before and after treatment of either 3 weeks on therapeutic nasal CPAP or sham nasal CPAP"|3 weeks of treatment on either therapeutic or sham nasal CPAP||||units on a scale||Standard Deviation|Mean
1281749|NCT00252629|Primary|Change of Fatigue Symptom|Fatigue- increasing impact was rated 1-7 using the fatigue severity scale on days 1 and 7 averaged, where 1= no fatigue and 7= severe fatigue.|3 weeks treatment with either therapeutic or sham CPAP||||units on a scale||Standard Error|Mean
1281750|NCT00252590|Secondary|Percentage of Days Abstinent From All Substances|Percentage of days abstinent from both alcohol and drugs|4 months||||percentage of days abstinent||Standard Deviation|Mean
1281751|NCT00252590|Primary|Percentage of Days Abstinent From Alcohol||4 months||||percentage of days abstinent alcohol||Standard Deviation|Mean
1281752|NCT00252564|Secondary|Overall Response Rate|Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all “per-protocol population” patients.|(during the whole treatment period)|This analysis included all eligible and treated patients, i.e. per-protocol population. A patient will be considered in the arm he/she is actually treated, not randomized.|||%||95% Confidence Interval|Number
1281753|NCT00252564|Secondary|Overall Survival (OS)|"From randomization to death (event); or last follow-up date if alive (censoring).~Kaplan-Meier OS median time."|(no predetermined maximum time)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.|||Month||95% Confidence Interval|Median
1281754|NCT00252564|Primary|Progression-free Survival (PFS)|"From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).~Kaplan-Meier median PFS time and PFS rate at 12 months."|(no pre-determined maximum time. PFS rate at 12 months)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.|||%||95% Confidence Interval|Number
1281755|NCT00252564|Primary|Progression-Free Survival (PFS)|"From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).~Kaplan-Meier median PFS time and PFS rate (at 12 months)"|(no pre-determined maximum time)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.|||month||95% Confidence Interval|Median
1281756|NCT00252538|Primary|Phenotype and Genotype Based on Presence of Interferon Induced MDD.|"Structured psychiatric interviews and symptom rating scales for depression were used as primary outcome measures to determine the association between phenotype (interferon-induced depression) and genotype (genes that confer risk of interferon-induced depression). Genes of interest related to development of depression and antiviral treatment response that may confer risk for interferon induced depression were examined. this was a multi-site study and included participants from several hospital settings.~Three polymorphisms of the interleukin (IL)-28b gene were examined - the c/c, c/t and t/t - and the relationship to MDD was examined. P-values above 0.05 are considered statistically insignificant in this study.~In a subsequent analysis of only VA participants proinflammatory cytokines and serotonin levels were examined relative to symptoms of depression."|The proposed enrollment began after funding notification and enrollment will last for a period of 40 months and until end of study.|This is an observational study that segregates patients with HCV and on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD. total sample from multiple sites.|||participants|||Number
1281757|NCT00252512|Secondary|Employment Status|Number of participants identifying themselves as unemployed.|8 week, 6 month and 12 month follow up|Fewer participants completed 6 and 12 month follow up assessments compared to 8 week follow up assessment.|||Participants|||Count of Participants
1281758|NCT00252512|Secondary|Legal Status|Number of participants reporting detention or incarceration in the previous 30 days|8 weeks, 6 month and 12 month follow ups|Lower numbers of participants returned for 6 and 12 month follow up assessments compared to 8 week follow up assessment.|||Participants|||Count of Participants
1281759|NCT00252512|Secondary|Housing|Number of participants reporting stable housing (owned or rented house, apartment or room)|8 week, 6 month and 12 month follow-ups|Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week follow up assessment.|||Participants|||Count of Participants
1282035|NCT00248833|Primary|Safety: Severity Summary of Solicited and Unsolicited Adverse Events|Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination|7 day f/u period after each vaccination||||AEs|||Number
1281761|NCT00252512|Secondary|Psychiatric Status|"Kessler Psychological Distress Scale (K10) - score range 10 to 50.~score under 20 are likely to be well~score 20-24 are likely to have mild psychological distress~score 25-29 are likely to have moderate psychological distress~score 30 and over are likely to have a severe psychological distress"|8 weeks, 6 months, 12 months|Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week assessment.|||units on a scale||Standard Deviation|Mean
1281762|NCT00252512|Primary|Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16||8 weeks||||negative alcohol and drug screens||Standard Deviation|Mean
1281763|NCT00252499|Secondary|Change in Hepatic Insulin Sensitivity From Baseline to 6 Months|Hepatic insulin sensitivity was determined as the percent suppression of endogenous glucose production (EGP) at the end of the low dose insulin clamp.|6 months||||percent of baseline EGP||Standard Error|Mean
1281764|NCT00252499|Secondary|Changes in Intra-abdominal Fat Area From Baseline to 6 Months|Unenhanced CT scan images were obtained on a General Electric Discovery HD750 CT scanner. Intra-abdominal (IAF) areas were measured at the top of the iliac crest and quantified using the Tomovision program (SliceOMatic V4.3) by one trained technologist.|6 months||||mm2||Standard Error|Mean
1281765|NCT00252499|Secondary|Change in Peripheral Insulin Sensitivity From Baseline to 6 Months|A two-step stable isotope labeled, hyperinsulinemic-euglycemic clamp procedure was performed with a low dose insulin infusion (20 mU/m2/min) for 3 hours followed by a primed high dose insulin infusion (160 mU/m2/min x 5 minutes then 80 mU/m2/min) for two hours. D20 was infused and adjusted to maintain the blood glucose at 90 mg/dl. Samples for glucose, insulin and 6,6 2d glucose were drawn every 15 minutes during the final half hour of the basal, low dose and high dose insulin periods. Whole body insulin sensitivity was calculated as the rate of glucose disposal (Rd)/lean body mass during the high dose insulin infusion.|6 months|One person in Arm 1 dropped out and thus is lacking 6 month data. The 6 month isotope data to calculate the rate of glucose disposal was not available for one subject in Arm 3.|||mg/min/kg||Standard Error|Mean
1281766|NCT00252499|Secondary|Change in the Liver Spleen Ratio by CT Scan From Baseline to 6 Months as a Measure of Fat in the Liver||6 months||||ratio||Standard Error|Mean
1281767|NCT00252499|Secondary|Change in Alanine Aminotransferase (ALT) Levels From Baseline to 6 Months||6 months||||U/L||Standard Error|Mean
1281768|NCT00252499|Primary|Liver/Spleen Ratio at 6 Months|Liver fat was estimated by non-contrast CT scan measuring the density ratio between the liver and spleen by Hounsfield units (liver/spleen ratio), which has been previously correlated with liver fat quantification by magnetic resonance spectroscopy.Ten separate measurements equally distributed throughout the liver and spleen were obtained and the Hounsfield units averaged. In subjects with more than one slice through the liver and spleen, the values for all slices were averaged.|6 months||||ratio||Standard Error|Mean
1281769|NCT00252382|Secondary|Best Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (PD); Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (SD). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).|168 days|Efficacy Analysis Population|||Participants|||Count of Participants
1281770|NCT00252382|Primary|Objective Tumor Response Rate|ORR is based on RECIST criteria to SNS-595 as a second-line therapy in patients with advanced NSCLC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|168 days|Efficacy Analysis Population|||Participants|||Count of Participants
1281771|NCT00252239|Primary|Functional Handicap (Modified Rankin Score)|The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score >=4 are reported.|3 months||||percentage of participants|||Number
1281772|NCT00252187|Secondary|Change in Left Ventricular Ejection Fraction at 8 Weeks|Left Ventricle Ejection Fraction (LVEF)is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a measure of the amount of blood pumped out of the lower chamber (ventricle) of the heart during a heartbeat, measured by Magnetic Resonance Imaging (MRI).|Baseline and 8 weeks|Per protocol population|||percentage||Standard Deviation|Mean
1281773|NCT00252187|Secondary|Change in Blood Pressure at 8 Weeks|Blood pressure was measured during the MRI|Baseline and 8 weeks|Per protocol population|||mmHg||Standard Deviation|Mean
1281774|NCT00252187|Secondary|Change in Heart Rate at 8 Weeks|Heart rate was measured when MRI was performed|Baseline and 8 weeks|Per protocol population|||beats per minute||Standard Deviation|Mean
1281775|NCT00252187|Primary|Change in Left Ventricular (LV) Mass Index at 8 Weeks||Baseline and 8 weeks|Per protocol population|||mg/m^2||Standard Deviation|Mean
1281776|NCT00252187|Secondary|Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks|Kidney function was measured by GFR determined by iothalamate clearance. Glomerular filtration rate describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body-surface area. A lower GFR means the kidney is not filtering normally.|Baseline and 8 weeks|Per protocol population|||ml/min/1.73 m^2 of body-surface area||Standard Deviation|Mean
1281777|NCT00252187|Secondary|Change in Plasma Renin Activity at 8 Weeks|Plasma renin is synthesized within circulation or at tissue sites, causing vasoconstriction or vasodilation.|Baseline and 8 weeks|Per protocol population|||nanograms per milliliter per hour||Standard Deviation|Mean
1281778|NCT00252187|Secondary|Change in Left Ventricular (LV) Filling Pressure at 8 Weeks|Filling pressure determined by ratio of E/e' [Echocardiograph Doppler mitral inflow velocity (E) to mitral annulus tissue Doppler velocity (e') ratio]|Baseline and 8 weeks|Per protocol population|||E/e'||Standard Deviation|Mean
1281779|NCT00252187|Primary|Change in Left Ventricular (LV) Volume Index at 8 Weeks|LV volume was measured for systolic volume and diastolic volume using a cardiac Magnetic Resonance Imaging (MRI) scan. All cardiac MRI images were reviewed by an independent cardiologist in a blinded fashion.|Baseline and 8 weeks|Per protocol population|||ml/m^2||Standard Deviation|Mean
1281782|NCT00252174|Secondary|The Hospital Anxiety and Depression Scale (HADS)|"Standardized assessment of anxiety and depression consisting of a 7-item anxiety scale and a 7-item depression scale. Each scale score ranges from 0 to 21, with 0-7 being normal and 11-21 being abnormal [e.g. severely depressed or anxious]"|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281783|NCT00252174|Secondary|Daily Experience of Pain - Visual Analog Pain Scale (VAPS)|daily measure of self-reported pain.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281784|NCT00252174|Secondary|Daily Use of Anxiolytics - Daily Diary|daily log of anxiolytic medication usage.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281785|NCT00252174|Secondary|Depression, Thoughts of Death - Schedule of Attitudes Toward Hastened Death (SAHD)|standardized questions to evaluate extent of depression and thoughts of death.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281786|NCT00252174|Secondary|Hamilton Depression Rating Scale (HAM-D)|Standardized interview assessing of depression, with higher scores indicative of greater depression. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281787|NCT00252174|Secondary|Quality of Life - Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (FACIT-Sp),Karnofsky Performance Rating Scale (KPRS), Memorial Symptom Assessment Scale (MSAS), Mini-Mental Status Exam (MMSE), Self-Expansiveness Level Form|paper pencil tests capturing data on spiritual well-being, overall functioning living with cancer, psychiatric mental status, and on spiritual self-perception.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281788|NCT00252174|Secondary|Anxiety - Hamilton Anxiety Rating Scale (HAM-A)|standardized assessment of anxiety|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281789|NCT00252174|Primary|Quality of Life - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)|"Self-report instrument assessing quality of life with five functional scales, and nine symptom scales. Higher functional scores indicate better quality of life and higher symptom scores indicate poorer quality of life. Scales include Yes / No responses and four-point Likert scales, with transformations performed on scores so that all scale scores range from 0 to 100."|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281790|NCT00252174|Primary|Spielberger State-Trait Anxiety Inventory (STAI)|Established self-report measure of anxiety containing a State and Trait subscale and scored on a four-point Likert scale. Scores for each subscale range from 10 to 40 and combined from 20 to 80 with higher scores indicative of greater anxiety.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
1281791|NCT00252057|Primary|Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.|The total number of rehospitalizations (emergency department visits plus hospital admissions) in the 30 days after discharge, compared across study arms. Participants could have more than one rehospitalization in this period; all rehospitalizations for each were counted, making the unit of measure the rehospitalizations and not the participants.|30 days after discharge||||Total number of rehospitalizations|||Number
1281792|NCT00251979|Secondary|Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period||Within 30 days||||days|||Number
1281793|NCT00251979|Secondary|Number of Blood Units Transfused Within 30 Days||within 30 days||||blood units|||Number
1281794|NCT00251979|Secondary|Number of Blood Units Transfused Within 72 Hours||Within 72 hours||||blood units|||Number
1281795|NCT00251979|Secondary|Requirement for Endoscopic Re-treatment Within 30 Days||Within 30 days||||Participants|||Number
1281796|NCT00251979|Secondary|Requirement for Endoscopic Re-treatment Within 72 Hours||Within 72 hours||||Participants|||Number
1281797|NCT00251979|Secondary|Requirement for Surgery Within 30 Days||Within 30 days||||Participants|||Number
1281798|NCT00251979|Secondary|Requirement for Surgery Within 72 Hours||Within 72 hours||||Participants|||Number
1281799|NCT00251979|Secondary|Death Related to Rebleeding Within 30 Days as Judged by the EpC||Within 30 days||||Participants|||Number
1281800|NCT00251979|Secondary|Death Within 30 Days||Within 30 days||||Participants|||Number
1281801|NCT00251979|Secondary|Death Within 72 Hours||Within 72 hours||||Participants|||Number
1281802|NCT00251979|Secondary|Clinically Significant Rebleeding Within 30 Days||Within 30 days||||Participants|||Number
1281803|NCT00251979|Secondary|Clinically Significant Rebleeding Within 7 Days||Within 7 days||||Participants|||Number
1281804|NCT00251979|Primary|Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo||Within 72 hours||||Participants|||Number
1281805|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn|At 5 year visit||||participants|||Number
1281806|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn|At 5 year visit||||participants|||Number
1281807|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn|At 5 year visit||||participants|||Number
1281808|NCT00251927|Secondary|Los Angeles (LA) Grade C at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit||||participants|||Number
1281809|NCT00251927|Secondary|Los Angeles (LA) Grade 'B' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit||||participants|||Number
1281810|NCT00251927|Secondary|Los Angeles (LA) Grade 'A' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit||||participants|||Number
1281811|NCT00251927|Secondary|Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit|Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included|At 5 year visit||||percentage of time recorded||Standard Deviation|Mean
1281812|NCT00251927|Secondary|Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit|The total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included|At 5 year visit||||units on a scale||Standard Error|Mean
1281813|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn|At 5 year visit||||participants|||Number
1281814|NCT00251927|Secondary|Los Angeles (LA) Grade 'Normal' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit||||participants|||Number
1281815|NCT00251927|Primary|Number of Participants With Treatment Failure at 5 Years|Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.|During 5 years||||participants|||Number
1281816|NCT00251862|Secondary|Screening Intentions|Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for “not at all sure” to 5 for “completely sure”.|Immediate post-intervention study visit||||units on a scale||Standard Deviation|Mean
1281817|NCT00251862|Secondary|Patient Satisfaction With Decision Making Process|Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for “strongly disagree” (or “poor”) to 5 for “strongly agree” (or “excellent”). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.|Immediate post-intervention primary care provider (PCP) visit||||units on a scale||Standard Deviation|Mean
1281818|NCT00251862|Secondary|Patient Knowledge|Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don’t know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.|Immediate post-intervention study visit||||units on a scale||Standard Deviation|Mean
1281819|NCT00251862|Primary|Patient Adherence (Test Completion)|Completion of a screening test within 12 months of the study visit.|12 months post-intervention|Intention to treat|||participants|||Number
1281820|NCT00251758|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Standard Deviation|Mean
1281821|NCT00251758|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Inter-Quartile Range|Median
1281844|NCT00251589|Secondary|Progression-free Survival|Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded).|Day 1 to disease progression or death|"All patients as treated population with post-baseline data available to determine progression free survival.~Cohort A, Dose Level 1 (Amended), Cohort B, Dose Level 2 and Cohort A, Dose Level 1 (Original) are not represented in the below table as post-baseline data were not available to determine progression free survival."|||Days||Full Range|Mean
1281822|NCT00251758|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.|||percentage of days||Standard Deviation|Mean
1281823|NCT00251758|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.|||percentage of days||Inter-Quartile Range|Median
1281824|NCT00251745|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Standard Deviation|Mean
1281825|NCT00251745|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Inter-Quartile Range|Median
1281826|NCT00251745|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.|||percentage of days||Standard Deviation|Mean
1281827|NCT00251745|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.|||percentage of days||Inter-Quartile Range|Median
1281828|NCT00251719|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||percentage of subjects|||Number
1281829|NCT00251719|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||percentage of subjects|||Number
1281830|NCT00251719|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||percentage of subjects|||Number
1281831|NCT00251719|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||percentage of subjects|||Number
1281832|NCT00251719|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|Week 8|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||percentage of subjects|||Number
1281833|NCT00251719|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analysis were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment that was performed within 7 days of the last day of study drug.|||percentage of subjects|||Number
1281834|NCT00251693|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||Percentage of subjects|||Number
1281835|NCT00251693|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||Percentage of subjects|||Number
1281836|NCT00251693|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||Percentage of subjects|||Number
1281837|NCT00251693|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||percentage of subjects|||Number
1281838|NCT00251693|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||percentage of subjects|||Number
1281839|NCT00251693|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||Percentage of subjects|||Number
1281840|NCT00251641|Secondary|Proportion of Participants Who Achieved a PGA Score of Cleared or Minimal at Week 26|PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).|26 weeks|ITT|||Proportion of participants|||Number
1281841|NCT00251641|Secondary|Proportion of Participants Who Achieved a Physician's Global Assessment (PGA) Score of Cleared or Minimal at Week 16|PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).|16 weeks|ITT|||Proportion of participants|||Number
1281842|NCT00251641|Secondary|PASI75 Response at Week 26|PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.|26 weeks|Intent-to-treat|||Proportion of participants|||Number
1281843|NCT00251641|Primary|Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16.|PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.|16 weeks|All subjects who were randomized were included in the efficacy analysis (intent-to-treat [ITT]).|||Proportion of participants|||Number
1282036|NCT00248807|Secondary|Cerebral Blood Flow|Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt|acute testing||||cm/sec||Standard Deviation|Mean
1281846|NCT00251589|Secondary|Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)|Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Progressive Disease as Best Response.|||Participants|||Number
1281847|NCT00251589|Secondary|Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)|Stable disease is defined as less than a radiographic partial response, but not progressive disease|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients treated population with post-baseline data available to determine Stable Disease as Best Response.|||Participants|||Number
1281848|NCT00251589|Post-Hoc|Dose Limiting Toxicity Occurring in Cycles 2 and Beyond of the Phase II Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycles 2 and beyond of the Phase II portion of the study.|After day 28 in the Phase II portion of the study|All patients as treated population in Cycles 2 and beyond of the Phase II portion of the study.|||Participants|||Number
1281849|NCT00251589|Primary|Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study.|Day 1 to 28 in the Phase II portion of the study|All patients as treated population in Cycle 1 of the Phase II portion of the study.|||Participants|||Number
1281850|NCT00251589|Secondary|Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)|An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable)|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Unconfirmed Partial Response as Best Response.|||Participants|||Number
1281851|NCT00251589|Primary|Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study.|Day 1 to 28 in the Phase I portion of the study|All patients as treated population in Cycle 1 of the Phase I portion of the study.|||Participants|||Number
1281852|NCT00251316|Primary|The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.||1 year||||Participants|||Number
1281853|NCT00251303|Primary|Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS)|CY-BOCS is a 0-40 point scale of obsessive-compulsive symptom severity, higher number indicates more severe obsessive-compulsive symptoms. Comparison of 12 weeks scores for placebo and riluzole groups.|12 weeks||||units on a scale||Standard Deviation|Mean
1281854|NCT00251303|Primary|Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I)||12 weeks||||participants|||Number
1281855|NCT00251238|Primary|Change From Baseline in Severity of Vasospastic Attacks|"Severity of the complains due to Vasospastic Attacks was measured using a 10-steps likert scale.~The scale ranged between 0 and 10, with higher scores indicating more severe attacks."|Baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
1281856|NCT00251238|Primary|Duration of Vasospastic Attacks||minutes per day||||minutes||Standard Deviation|Mean
1281857|NCT00251238|Primary|Frequency of Vasospastic Attacks||Number of Vasospastic Attacks per day, for up to 10 weeks||||attacks per day||Standard Deviation|Mean
1281858|NCT00251225|Secondary|Overall Survival (OS)|OS is the amount of time in months from the date of registration to the date of death from any cause.|Up to 60 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib|||months||95% Confidence Interval|Median
1281859|NCT00251225|Secondary|Prostate-Specific Antigen (PSA) Response Rate|PSA response rate is the number of participants who experienced a best response of: complete response, CR (PSA less than or equal to 0.2 ng/mL, documented two or more times, a minimum of four weeks apart), partial response, PR (a decline in PSA by at least 50%, confirmed by a second PSA value four or more weeks later) or stable disease (does not qualify for CR, PR, Progression or Symptomatic Deterioration, at least 6 weeks after registration) / total number of analyzable patients.|Up to 12 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib|||percentage of patients|||Number
1281860|NCT00251225|Primary|Overall Time To Progression (TTP)|TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 24 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib|||months||95% Confidence Interval|Median
1281861|NCT00251004|Secondary|Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula|"Modification of Diet in Renal Disease (MDRD) formula is:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|at 12 months|Intention to treat (ITT) population.|||mL/min/1.73m^2|||Number
1281890|NCT00250679|Secondary|Modified Medical Research Council Dyspnea Questionaire|Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.|Baseline (visit 2), weeks 13, 26|ITT Population|||units on a scale||Standard Deviation|Mean
1281862|NCT00251004|Primary|Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints|The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window.|12 months|Intention-to-treat population|||Percentage of Participants|||Number
1281863|NCT00251004|Secondary|Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation|"Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant.~A loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316."|12 months|Intention-to-treat (ITT) population.|||Percentage of participants|||Number
1281864|NCT00251004|Primary|Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis|The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.|12 months|Intention-to-treat (ITT) population|||Participants|||Number
1281865|NCT00250926|Primary|Time to Progression|Progressive Disease (PD) will be defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).|42 months|The median time to progression was not achieved as follow-up ended before half the participants had a PD event.|||months||Full Range|Median
1281866|NCT00250926|Primary|Time to Best Response||33.2 months||||Months||Full Range|Median
1281867|NCT00250926|Primary|Response Rate|"This outcome measure was to determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. The response rates were defined as follows.~A complete response (CR) was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, absence of bone marrow disease by bone marrow biopsy and aspiration, and resolution of any adenopathy or splenomegaly. A near complete response (nCR) was defined as fulfilling all CR criteria in the presence of a positive immunofixation study. Patients with very good partial response (VGPR), partial response (PR), and minor response (MR) were defined as having a ≥ 90%, ≥ 50%, and 25% to 49% reduction in serum IgM levels, respectively. Progressive disease (PD) occurred when a more than 25% increase in serum IgM level or progression of clinically significant disease parameters was observed."|33.2 months|all enrolled patients|||participants|||Number
1281868|NCT00250926|Primary|Number of Participants With Adverse Events|This outcome measure was to assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia.|33.2 months|All enrolled patients|||participants|||Number
1281869|NCT00250835|Secondary|Pelvic Local Control Rate|Pelvic local control rate is defined as the proportion of subjects who have no evidence of pelvic recurrence (by standard clinical assessment, including CT scan and clinical examination) at the final follow-up evaluation, out of all evaluable patients|Up to 3 years after surgery||||percentage of evaluable participants|||Number
1281870|NCT00250835|Secondary|Surgical Downstaging Rate|Downstaging rate after neoadjuvant treatment with combination oxaliplatin, capecitabine, celecoxib and concurrent radiation is defined as the proportion of patients whose pathological stage (stage at surgery) is different from their clinical stage (stage at baseline)|At surgery (up to 6 weeks after treatment)||||percentage of evaluable participants||95% Confidence Interval|Number
1281871|NCT00250835|Secondary|Incidence of Sphincter-sparing Surgery|Incidence of sphincter-saving surgery is defined as the proportion of subjects who do not have permanent colostomy at the final follow-up out of all evaluable patients.|At surgery (up to 6 weeks after end of treatment)||||percentage of evaluable participants||95% Confidence Interval|Number
1281872|NCT00250835|Secondary|Progression-free Survival (PFS)|"The Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (Version 1.0) will be used to determine tumor response and progression. Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions. Time to progression will be measured from the time of surgery or clinically documented down staging if surgery for whatever reason is not carried in the subject until there is evidence of PD.~Progression-free survival is reported as the percentage of patients who have not experienced progression of disease at three years post-surgery"|3 years after surgery||||percentage of evaluable participants||95% Confidence Interval|Number
1281873|NCT00250835|Secondary|Toxicity|"All toxicities encountered during the study will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0.~Toxicity will be reported as the proportion of subjects experiencing Grades 3,4, and 5 adverse events (AEs) out of all evaluable patients"|Up to 3 years||||percentage of participants|||Number
1281874|NCT00250835|Primary|Pathologic Complete Response (PCR)|The pathologic complete response (PCR) rate will be calculated as the proportion of patients who achieve complete response out of all evaluable patients. PCR is defined as the total absence of residual tumor cells by microscopic examination of the resected surgical specimen, including all of the sampled lymph nodes.|At surgery (up to 6 weeks after end of treatment)|Patients who continue on at least two of the three drugs for a minimum of 14 days are considered evaluable for the primary objective|||percentage of evaluable participants||95% Confidence Interval|Number
1281875|NCT00250718|Secondary|Toxicity||End of 2 cycles (cycle = 28 days)|Trial was terminated early due to low accrual; no data to report. Adverse event data for enrolled patients is reported in the adverse event results section.||||||
1281876|NCT00250718|Primary|Overall Response Rate (ORR), the Sum of Complete and Partial Responses|"Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0).~For CLL: complete remission (CR) requires the following for>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count<4,000/µL, 4) ANC>1,500/µL, 5) platelets>100,000/µL, 6) hemoglobin>11 g/dL, 7) bone marrow lymphocytosis<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for >=2 months 1) decrease in previously enlarged nodes, spleen, and liver by >=50%, 2) ANC>=1,500/µL or platelets>=100,000/µL, 3) hemoglobin>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets.~For MM, CR is no monoclonal protein (M-protein) in blood and urine and <5% plasma cells in bone marrow on >=2 determinations >=6 wk apart & stable bone disease & calcium levels. PR is>50% and >90% decreases in serum & urine M-protein, respectively, on >=2 occasions for >=6 wk, stable bone disease & calcium."|Up to 6 months after first on-study treatment|Trial was terminated due to low accrual; no data to report. An insufficient number of subjects were accrued to report data accurately.||||||
1281877|NCT00250705|Secondary|Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved; 2. Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; or 7. Much worse)|6 weeks||||units on a scale||Standard Deviation|Mean
1281878|NCT00250705|Primary|Children's Aggression Scale-Parent Version|"CAS-P is a 33 item scale representing 5 domains of aggression: Items in a domain were computed based on two reference points. The first was based on a 5 point frequency range with 0 being best (never) and 4 (> 10 times being) worst. These same items were then adjusted such that more severe acts would be weighted more heavily compared to less severe aggressive behaviors. Within a domain, 0 was the best score. Worst score for the various aggression domains were: Verbal 26.16, Against Objects and Animals 11.8, Provoked 15.84, Initiated 17.84, and Use of Weapons 13.16."|6 weeks|ITT|||units on a scale||Standard Deviation|Mean
1281879|NCT00250705|Secondary|Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1. Normal, not at all ill; 2. Borderline mentally ill, 3. Mildly ill; 4. Moderately ill; 5. Markedly ill; 6. Severely ill; or 7. Among the most extremely ill patients.|6 weeks||||units on a scale||Standard Deviation|Mean
1281880|NCT00250705|Primary|Overt Aggression Scale-Modified (OAS-M)|"OAS-M divides aggressions into 4 subtypes: 1) verbal aggression, 2) property aggression, 3) self aggression (autoaggression), and 4) physical aggression. Each subtype has an initial score ranging from 0 (least aggressive) to 4 (most aggressive). The score for each subscale is further weighed (multiplied) by a constant: verbal scale's constant is 1 (max adjusted score of 4); property scale's constant is 2 (max adjusted score 8); self scale's constant is 3 (max adjusted score 12); and physical scale's constant is 4 (max adjusted score of 16). Within a given scale, 0 is the best score and maximum adjusted scale score is worst."|6 weeks|ITT|||units on a scale||Standard Deviation|Mean
1281881|NCT00250705|Primary|The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)|Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) is a global rating scale of aggression completed by clinicians. Score given based on following severity scale with subject assigned 1 number: Intolerable behavior-frequently physically attacks others and destroys property (5); Severe-occasionally physically attacks people and destroys property (4); Moderately 21); and No aggressiveness reported (1). A minimum score of 1 is best and a maximum score of 5 is worst. There are no subscale scores.|6 weeks|ITT|||units on a scale||Standard Deviation|Mean
1281882|NCT00250679|Secondary|Mean Values for Forced Expiratory Volume in One Second (FEV1)|Forced Expiratory Volume in one second|Baseline (Visit 2), weeks 3, 13, 26||||Liters||Standard Deviation|Mean
1281883|NCT00250679|Secondary|Mean Values for Inspiratory Capacity|Inspiratory capacity is the maximum volume that can be inhaled.|Baseline (Visit 2), Weeks 3, 13, 26||||Liters||Standard Deviation|Mean
1281884|NCT00250679|Secondary|Mean Values for Subject Global Evaluations|The subject global evaluation is reported by study subjects/participants. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.|Baseline (Visit 2), weeks 13, 26|ITT Population|||units on a scale||Standard Deviation|Mean
1281885|NCT00250679|Secondary|Mean Values for St. George's Respiratory Questionnaire|A questionnaire to assess respiratory health. Scores are expressed as a percentage of overall impairment (total score), where 100 represents the worst possible health status and 0 indicates best possible health status.|Baseline (Visit 2), weeks 13, 26|ITT population|||units on a scale||Standard Deviation|Mean
1281886|NCT00250679|Secondary|Mean Values for Investigator Global Evaluations|The investigator global evaluation is reported by the study investigator. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.|Baseline (Visit 2), Weeks 13, 26|ITT population|||units on a scale||Standard Deviation|Mean
1281887|NCT00250679|Secondary|Mean Values for the 6-Minute Walk Test: Distance Walked in Meters|This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes.|Baseline (Visit 2), week 13, week 26|ITT population|||meters||Standard Deviation|Mean
1281888|NCT00250679|Secondary|Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire|Percent of participants with a >=4 unit improvement in the overall impairment (total score) of the St. George's Respiratory Questionaire. This questionaire uses a 100 - 0 scale, where 100 represents the worst possible health status and 0 indicates the best possible health status.|visit 4 (week 13), visit 5 (week 26)|ITT population|||percent of participants|||Number
1281889|NCT00250679|Secondary|Percent (%) of Participants With an Improved Transitional Dyspnea Index|The percentage of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score is the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.|visits 4 (week 13), visit 5 (week 26)|"ITT population. Percentages were based on the number of subjects with non-missing data.~Visit 4 n=115, 113, 114 Visit 5 n=108, 102, 103"|||percent of participants|||Number
1281891|NCT00250679|Secondary|Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire|Scores are expressed as the number of participants with >= 4 unit improvement in overall impairment (total score), where 100 represents worst possible health status and 0 indicates best possible health status.|Visit 4 (week 13) , Visit 5 (week 26)|ITT Population|||Participants|||Number
1281892|NCT00250679|Secondary|Mean Change From Baseline in St. George's Respiratory Questionnaire|Scores are expressed as a mean change from baseline of overall impairment (total score). The questionnaire has a scale of 100 which represents worst possible health status to 0 which indicates best possible health status.|weeks 13, 26|ITT Population|||units on a scale||95% Confidence Interval|Mean
1281893|NCT00250679|Secondary|6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes|Mean change from baseline in distance walked (meters)|Post-Dose weeks 0, 13, 26|ITT Population|||meters||95% Confidence Interval|Mean
1281894|NCT00250679|Secondary|BODE Index|The BODE index (0=relative health and 10=severe chronic obstructive pulmonary disease) is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the 6-minute walk test. Scores were derived using pre-dose assessments from each visit.|Baseline (visit 2), weeks 13, 26|ITT Population|||units on a scale||Standard Deviation|Mean
1281895|NCT00250679|Secondary|Investigator Global Evaluations Change From Baseline|The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. Ratings were assessed relative to the subject's initial entry into the study.|weeks 13, 26|ITT Population|||units on a scale||95% Confidence Interval|Mean
1281896|NCT00250679|Secondary|Subject Global Evaluations Change From Baseline|The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1=much better and 7=much worse. Ratings were assessed relative to the subject's initial entry into the study.|weeks 13, 26|ITT Population|||units on a scale||95% Confidence Interval|Mean
1281897|NCT00250679|Secondary|Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)|The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value.|weeks 0,3,13,26|ITT Population|||Liters||95% Confidence Interval|Mean
1281898|NCT00250679|Secondary|Number of Participants With an Improved Transitional Dyspnea Index|The number of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score compares current health against baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.|weeks 13, 26|ITT Population. Visit 4 n=115,113,114 Visit 5 n=108,102,103|||Participants|||Number
1281899|NCT00250679|Secondary|Transitional (Relative Change in) Dyspnea Index|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A Transitional Dyspnea Index score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|weeks 13, 26|ITT Population|||units on a scale||95% Confidence Interval|Mean
1281900|NCT00250679|Secondary|Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline|Area under the change from baseline curve from 0 to 6 hours. Time-normalized AUC (0-6 hrs) was derived using the linear trapezoidal method.|weeks 0,3,13,26|ITT Population. Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.|||Liter||95% Confidence Interval|Mean
1281901|NCT00250679|Secondary|Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day|Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population|||Actuations/Day||95% Confidence Interval|Mean
1281902|NCT00250679|Secondary|Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week|Rescue medication usage during the study. MDI stands for metered dose inhaler.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population|||Days Used / Week||95% Confidence Interval|Mean
1281903|NCT00250679|Secondary|Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day|Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population|||Actuations / Day||95% Confidence Interval|Mean
1281904|NCT00250679|Secondary|Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week|Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population|||Days Used / Week||95% Confidence Interval|Mean
1281905|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Heart Rate|Number of subjects with a heart rate that was lower/higher than a set limit and increased/decreased from set baseline limit in beats per minute (bpm)|visit 6 (week 27)||||Participants|||Number
1281906|NCT00250679|Secondary|6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)|The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit.|weeks 0,3,13,26|ITT population. An available cases analysis was performed with no imputation for missing data.|||Liter||95% Confidence Interval|Mean
1281907|NCT00250679|Secondary|Inspiratory Capacity Changes From Baseline|Mean Change in Inspiratory Capacity values from baseline (baseline assessment obtained at Visit 2, pre-dose). Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.|weeks 0,3,13,26|ITT Population This outcome was added as an amendment after the study was initiated; therefore approximately half of the ITT population had these assessments at baseline. An available cases analysis was performed with no imputation for missing data.|||Liter||95% Confidence Interval|Mean
1281908|NCT00250679|Secondary|Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts|New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline.|visit 6 (week 27)|ITT Population|||Participants|||Number
1281909|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Potassium Evaluations|Patients with potassium values that met low (<=3 mEq/L) or high (>=6 mEq/L) criteria were considered potentially clinically significant.|visit 6 (week 27)|ITT Population|||Participants|||Number
1281913|NCT00250588|Secondary|Asthma Symptoms|Asthma symptom frequency was measured via the number of days and nights with asthma symptoms over the past two weeks. Night time asthma symptoms were converted to number of subjects experiencing night time asthma symptoms more than 1 time per week.|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.|||participants|||Number
1281914|NCT00250588|Secondary|Counts of Patients With One or More Asthma-related Emergency Department Visits.|Utilization was measured by parent recall of emergency room visits for asthma over the last 6 months (at T1), 3 months (at T2), and 6 months (at T3).|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3.|||participants|||Number
1281915|NCT00250588|Primary|Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)|The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, & Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a ‘problem’ in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.|||units on a scale||Standard Error|Mean
1281916|NCT00250497|Secondary|Body Satisfaction|Ten questions assessing satisfaction with weight, height, and specific parts of the body; six Likert response categories.Body Satisfaction Scale Range=10-60 with higher values indicating increased body satisfaction.|One year||||units on a scale||Standard Deviation|Mean
1281917|NCT00250497|Secondary|Unhealthy Weight Control Behaviors|Ten questions assessing use of unhealthy weight control behaviors in the past month (yes/no). Behavior categories included fasted, ate very little, took diet pills, made myself vomit, used laxatives, used diuretics, used food substitutes, skipped meals, smoked more cigarettes, and went on a diet. If a respondent reported doing any of these behaviors, they were classified as having used unhealthy weight control behaviors.|One Year||||percentage of participants|||Number
1281918|NCT00250497|Secondary|Sedentary Activity|The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of sedentary activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of sedentary activity per day|One Year||||average number of 30-minute blocks/day||Standard Deviation|Mean
1281919|NCT00250497|Secondary|Fruits and Vegetables||One year||||Servings/day||Standard Deviation|Mean
1281920|NCT00250497|Secondary|Level of Physical Activity|The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of physical activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of physical activity.|One year||||average number of 30-minute blocks/day||Standard Deviation|Mean
1281921|NCT00250497|Primary|Percent Body Fat|Measured with DEX-A at baseline and 1 year follow-up|Baseline and One year||||% body fat (DXA)||Standard Deviation|Mean
1281922|NCT00250484|Secondary|Medication Use (Medication Diary)|Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.|Baseline and end of treatment at approximately 1 year|Data was not collected. Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.||||||
1281923|NCT00250484|Secondary|Cognitive Assessment - Neuropsychological Battery|"Beck Depression Inventory (BDI), and Visual Analog Scale (VAS) for anxiety were assessed in subjects both as a baseline score before treatment was initiated as and upon conclusion of treatment.~BDI is a 0-63 scale increasing with depression severity. A score from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 28-63 indicates severe depression. Higher values represent a worse outcome.~VAS is a pain assessment ranging from 0-10 increasing with pain severity. High values represent a worse outcome."|Baseline and end of treatment at approximately 1 year||||units on a scale||Standard Deviation|Mean
1281924|NCT00250484|Primary|Pain (Visual Analog Scale, CGI, PGA)|Pain intensity and therefore changes in pain intensity were assessed using a 0-10 Visual Analog Scale where 0 represents the least amount of pain and 10 is the most pain imaginable. The pain evaluation was carried out by a blinded rater based off 1) baseline evaluation: 3 week long pain logs and a diary of pain medication intake, 2) treatment evaluations: participants were also asked to fill out daily pain logs following each TMS session and to keep a diary of pain medications during the CRC stay for the TMS course and 3)follow-up evaluation: finally, there was a follow up measurement 3 weeks after treatment.|1 year||||number of participants w/ reduced pain|||Number
1281925|NCT00250458|Secondary|Participants With Pain Relief at 2 Hours Postdose|Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.|2 hours after treatment|Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
1281972|NCT00249795|Secondary|First Occurrence of Stroke|The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.|||participants|||Number
1281926|NCT00250458|Primary|Participants With Elimination of Nausea at 2 Hours Postdose|Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.|At 2 hours after treatment|Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
1281927|NCT00250432|Secondary|Number of Patients With a Favorable Overall Response.|"Number of patients with a favorable overall response, defined as a clinical response of cure or apparent cure along with a microbiological response of eradication or presumptive eradication at the End of Caspofungin Therapy."|90 Days|Full Analysis Set (FAS): Included those patients who received at least 1 full dose of caspofungin study therapy and had a documented diagnosis of invasive candidiasis from a sterile, invasive body site, as defined in the protocol.|||Participants|||Number
1281928|NCT00250432|Primary|Number of Patients Who Develop Significant Drug-related Adverse Events.|Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.|90 Days|All patients as treated population|||Participants|||Number
1281929|NCT00250276|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1281930|NCT00250276|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1281931|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Day 0-29) post vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
1281932|NCT00250276|Secondary|Number of Subjects With MSAEs|MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
1281933|NCT00250276|Secondary|Number of Subjects With (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
1281934|NCT00250276|Secondary|Number of Subjects With Medically Significant Adverse Events (MSAEs)|MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
1281935|NCT00250276|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
1281936|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
1281958|NCT00249821|Secondary|Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels||Baseline (randomization), Month 6 and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."|||milligram/L (mg/L)||Standard Deviation|Mean
1281937|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
1281938|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
1281939|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1281940|NCT00250276|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1281941|NCT00250276|Secondary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18|Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .|At Month 2|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.|||Participants|||Count of Participants
1281942|NCT00250276|Secondary|Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.|At Month 2|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.|||Participants|||Count of Participants
1281943|NCT00250276|Primary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18|Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.|At Month 7|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.|||Participants|||Count of Participants
1281944|NCT00250276|Primary|Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.|At Month 7|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.|||Participants|||Count of Participants
1281945|NCT00249873|Secondary|Adjudicated Major Bleedings|The number of participants with at least one major bleeding, validated by the Event Adjudication Committee are counted over the duration of the follow-up (including after permanent discontinuation of the study drug).|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
1281946|NCT00249873|Secondary|Death From Any Cause (Cardiovascular and Noncardiovascular)|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
1281947|NCT00249873|Secondary|Occurrence of Stroke|The event is the occurence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) after validation of the Event Adjudication Committee . The analysis is performed on the time from randomization to the occurrence of this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for this analysis.|||participants|||Number
1281948|NCT00249873|Primary|First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication|"The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :~stroke (nonfatal or fatal)~myocardial infarction (nonfatal or fatal)~non-CNS systemic embolism~vascular death~The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group."|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient’s compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.|||participants|||Number
1281949|NCT00249834|Secondary|Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate|Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|35-42 days post r-hCG administration|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||Percentage of subjects|||Number
1281950|NCT00249834|Secondary|Embryo Implantation Rate|Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|35-42 days post r-hCG administration|"ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here overall number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||Percent sacs per embryo||Standard Deviation|Mean
1281951|NCT00249834|Secondary|Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose|As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|up to end of stimulation cycle (approximately 31 days)|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||IU/day||Standard Deviation|Mean
1281952|NCT00249834|Secondary|Number of Subjects Needing Dose Adjustment|Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|6 days post r-hFSH treatment|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||subjects|||Number
1281953|NCT00249834|Secondary|Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH|As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|up to end of stimulation cycle (approximately 31 days)|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||Percentage of cycles|||Number
1281954|NCT00249834|Secondary|Mean Number of Ovarian Stimulation Days|The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|up to end of stimulation cycle (approximately 31 days)|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||Days||Standard Deviation|Mean
1281955|NCT00249834|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)|As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|up to end of stimulation cycle (approximately 31 days)|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||International Units (IU)||Standard Deviation|Mean
1281956|NCT00249834|Primary|Number of Oocytes Retrieved|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|Ovum pick up day (34 to 38 hours post r-hCG administration)|"Intention-To-Treat (ITT) population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here overall number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||Oocytes||Standard Deviation|Mean
1281957|NCT00249821|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse Events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the Investigational Medicinal Product (IMP).|Baseline (randomization) until Month 12|The safety population included all the participants who received at least 1 dose of study medication.|||participants|||Number
1282037|NCT00248807|Primary|Systolic Blood Pressure|Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention|acute testing|convenience sample|||mmHg||Standard Deviation|Mean
1281959|NCT00249821|Secondary|Insulin Like Growth Factor-1 (IGF-1) Levels||Baseline (randomization), Month 6 and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."|||microgram/liter (mcg/L)||Standard Deviation|Mean
1281960|NCT00249821|Secondary|Change From Baseline in Bone Age at Month 12|Bone age was assessed by a left wrist X-Ray and evaluated by the investigator according to the Greulich and Pyle method.|Baseline (randomization) and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."|||years||Standard Deviation|Mean
1281961|NCT00249821|Secondary|Change From Baseline in Height at Month 6||Baseline (randomization) and Month 6|FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.|||cm||Standard Deviation|Mean
1281962|NCT00249821|Secondary|Height Velocity-Standard Deviation Score (HV-SDS)|Height Velocity-Standard Deviation Score (HV-SDS) was calculated as height velocity minus reference mean height velocity divided by SD of the reference mean height velocity. Greater HV-SDS indicates greater height velocity.|Month 6 and Month 12|"FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Here n signifies number of participants analyzed at that particular time point for each arm group respectively. LOCF was used to impute missing values."|||standard deviation score||Standard Deviation|Mean
1281963|NCT00249821|Secondary|Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12|Height-Standard Deviation Score (H-SDS) was calculated as height minus mean (age-and sex-matched reference) divided by standard deviation (SD) [age and sex-matched reference]. Greater H-SDS indicates greater height.|Baseline (randomization), Month 6 and Month 12|FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.|||standard deviation score||Standard Deviation|Mean
1281964|NCT00249821|Primary|Height Velocity|Height Velocity (HV) is the change in height since the previous year´s measurement and more precisely: HV = {(h-hp)/(d-dp)} * 365.25 [centimeter (cm)/year] where h is current height in cm, hp is previous height in cm, closest to 1 year previous, d is the current date and dp is the date of measurement of previous height, closest to 1 year previous. Additionally, d and dp have to be within 0.6 years and 1.5 years. HV is the mean height velocity over the interval between d and dp but is displayed as HV at d.|Month 12|Full Analysis (FA) set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Last observation carried forward (LOCF) was used to impute missing values.|||centimeter (cm)/year||Standard Deviation|Mean
1281965|NCT00249808|Secondary|Percentage of Participants With Psoriasis Exacerbation|Exacerbation was defined as disease worsening either during or after treatment which was more inflammatory in nature compared to baseline and occurred either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease.|During study (40 weeks)|ITT population. Here, overall number of participants analyzed = participants who failed to respond (PGA less than good) at Week 12.|||percentage of participants|||Number
1281966|NCT00249808|Secondary|Percentage of Participants With Psoriasis Rebound|Rebound was defined as worsening of disease as assessed by Psoriasis Area and Severity Index (PASI) score >125% of baseline or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 2 months of stopping therapy. PASI is an instrument used to assess the extent of cutaneous psoriasis and to measure the effects of therapy. The PASI divides the body into four anatomical regions: head, trunk, upper limbs, and lower limbs. For each region, the evaluator assesses the severity of erythema, induration/thickness and scaling and determines the percentage of the region affected by disease. A numerical PASI score is derived that evaluates the severity of symptoms in terms of the total body surface area affected. Total PASI score ranges from 0 to 72, with higher scores indicating more severe disease.|Up to 8 weeks after end of FT (up to Week 20)|Observation population included all participants had stopped treatment with efalizumab following the FT (Week 12) and who had responded to treatment during (PGA good or better ) FT. Here, overall number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1281967|NCT00249808|Primary|Percentage of Participants With Physician’s Global Assessment (PGA) Ratings of Good or Better (FT)|The PGA assesses the global response of all psoriatic lesions to therapy by comparing the participant’s present condition to baseline. PGA response includes: Cleared (100 percent [%] improvement; remission of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Excellent (75% to 99% improvement of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Good (50% to 74% improvement of all clinical signs and symptoms); Fair (25% to 49% improvement of all clinical signs and symptoms); Slight (1% to 24% improvement of all clinical signs and symptoms); Unchanged (clinical signs and symptoms unchanged); Worse (clinical signs and symptoms deteriorated). Percentage of participants with PGA ratings of Good or Better (i.e, Good, Excellent or Cleared) are reported.|Week 12|ITT population.|||percentage of participants||95% Confidence Interval|Number
1281968|NCT00249795|Secondary|First Hospitalisation for Other Cardiovascular (CV) Cause|The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
1281969|NCT00249795|Secondary|First Hospitalisation for Heart Failure (HF)|The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.|||participants|||Number
1281970|NCT00249795|Secondary|First Occurrence of Any Heart Failure (HF) Episode|The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
1281973|NCT00249795|Primary|First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication|The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.|||participants|||Number
1281974|NCT00249795|Primary|First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication|The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient's compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.|||participants|||Number
1281975|NCT00249613|Primary|Any Substance Use Past 30 Days|Substance use in past 30 days at 12 months post intake|12 Months||||Odds ratio||95% Confidence Interval|Number
1281976|NCT00249613|Secondary|Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model|Predictors of change in employment at 12 months post intake: GEE - comparison of Women-Only vs. Mixed-Gender treatment models|12 month post intake||||Beta coefficient||95% Confidence Interval|Number
1281977|NCT00249613|Primary|Predictors of Criminal Activity at 12 Months Post Intake||12 Months||||Odds ratio||95% Confidence Interval|Number
1281978|NCT00249613|Primary|Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment||baseline and 1-year follow-up|Intention to treat (ITT)|||Percentage reporting criminal activity|||Number
1281979|NCT00249496|Secondary|HIV Risk Behaviors|Percentage of people reporting that they traded sex for drugs or money|1 year|intent to treat|||percentage of participants||Full Range|Mean
1281980|NCT00249496|Secondary|Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates|"(The number of Monday, Wednesday and Friday urine samples negative for opiates/total number of urine samples) x 100.~We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial."|1 year|This measure was not analyzed due to limited funding to confirm the accuracy/completeness of the Mon, Wed, Fri urine data.||||||
1281981|NCT00249496|Secondary|Percentage of 30-day Assessment Urine Samples Negative for Opiates|(The number of monthly urine samples negative for opiates/total number of urine samples) x 100|1 year|intent to treat|||percentage of opiate negative||Full Range|Mean
1281982|NCT00249496|Secondary|Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine|"(The number of Monday, Wednesday and Friday urine samples negative for cocaine/total number of urine samples) x 100.~We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial."|1 year|This measure was not analyzed due to limited funding to confirm the accuracy/completeness of the Mon, Wed, Fri urine data||||||
1281983|NCT00249496|Primary|Percentage of Monthly Urine Samples That Are Negative for Cocaine|The percentage of urine samples collected at monthly assessments that are negative for cocaine.|1 year||||percentage of urine samples||Full Range|Mean
1281984|NCT00249470|Secondary|HIV Risk Behaviors|Report no injection drug use or crack cocaine use.|every month for 6 months|The data represent the mean percentage of participants that reported no injection drug use or crack cocaine use. Missing assessments were considered positive (i.e., injection drug or crack cocaine use).|||percentage of participants||Full Range|Mean
1281985|NCT00249470|Secondary|Percent Opiate Negative|(total number of opiate-negative urine samples divided by the total number of urine samples provided)*100|every month for 6 months|intent to treat|||percentage of opiate negative||Full Range|Mean
1281986|NCT00249470|Primary|Cocaine Abstinence|Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine|6 months||||percentage of cocaine negative||Full Range|Mean
1281987|NCT00249444|Primary|Depression Score on Hamilton - Depression 25 Item|Participants those who had a 50% decrease in HAM-D scores from baseline at end of study. The outcome measured is 50% drop in Hamilton score at week 8 or last week of study participation compared to baseline. We looked at the difference between baseline score and score at week 8 or last week of study participation.|End of 8 week study or last week of participation||||participants|||Number
1281988|NCT00249444|Primary|Cocaine Abstinence During Last Three Weeks of Study|measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation|measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation||||participants|||Number
1281989|NCT00249379|Secondary|Recidivism Rates|Number of participants returning to jail during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."|||participants|||Number
1281990|NCT00249379|Secondary|Retention in Drug Court|Number of participants remaining in drug treatment court program during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."|||participants|||Number
1281991|NCT00249379|Primary|Level of Acceptance|Number of participants taking study medication during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."|||participants|||Number
1282009|NCT00249249|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks|high sensitivity C-reactive protein (hs-CRP) at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||mg/L||Standard Deviation|Mean
1281992|NCT00249379|Primary|Drinking and Other Drug Use|Number of participants using alcohol and other drugs during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."|||participants|||Number
1281993|NCT00249288|Secondary|Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients|Baseline blood homocysteine lab levels are reported by deficit syndrome status.|Baseline|One participant without deficit syndrome is missing homocysteine. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are compared across deficit syndrome status.|||micromoles/liter||Standard Deviation|Mean
1281994|NCT00249288|Secondary|Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients|Baseline blood B12 lab levels are reported by deficit syndrome status.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across deficit syndrome status.|||picograms/mL||Standard Deviation|Mean
1281995|NCT00249288|Secondary|Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients|Baseline blood folate lab levels are reported by deficit syndrome status.|Baseline|One deficit syndrome participant and one participant without deficit syndrome are missing RBC folate values. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across deficit syndrome status.|||nanograms/mL||Standard Deviation|Mean
1281996|NCT00249288|Primary|Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake|Baseline blood folate and B12 lab levels and dietary intake levels are reported.|Baseline|All participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, folate and B12 levels are described for all baseline participants.|||micrograms||Standard Deviation|Mean
1281997|NCT00249288|Primary|Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake|Baseline blood homocysteine lab levels and dietary intake levels are reported.|Baseline|All study participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are described for all baseline participants.|||micromoles/liter||Standard Deviation|Mean
1281998|NCT00249288|Primary|Correlation Between Baseline Serum B12 Levels and Dietary Intake|Baseline serum B12 lab levels and dietary intake levels are reported.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, B12 levels are described for all baseline participants.|||picograms/mL||Standard Deviation|Mean
1281999|NCT00249288|Primary|Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype|Baseline blood homocysteine lab levels are reported by MTHFR genotype.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, homocystein levels are compared across MTHFR genotype.|||micromoles/liter||Standard Deviation|Mean
1282000|NCT00249288|Primary|Correlation Between Baseline Blood B12 Levels and MTHFR Genotype|Baseline blood B12 lab levels are reported by MTHFR genotype.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across MTHFR genotype.|||picograms per milliliter||Standard Deviation|Mean
1282001|NCT00249288|Primary|Correlation Between Baseline Homocysteine Levels and Smoking Status|Baseline blood homocysteine lab levels are reported by smoking status.|Baseline|1 participant who have never smoker status is missing plasma homocysteine values. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are compared across smoking status.|||micromoles per liter||Standard Deviation|Mean
1282002|NCT00249288|Primary|Correlation Between Baseline Serum B12 Levels and Smoking Status|Baseline serum B12 lab levels are reported by smoking status.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across smoking status.|||picograms per milliliter||Standard Deviation|Mean
1282003|NCT00249288|Primary|Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total|The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) modified total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score). The SANS modified total score is the SANS total score minus the Attention subscale.|Baseline score vs. week 12 score||||Units on a scale||Standard Deviation|Mean
1282004|NCT00249288|Primary|Correlation Between Baseline Blood Folate Levels and Dietary Intake|Baseline blood folate lab levels and dietary intake levels are reported.|Baseline|All study participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, folate levels are described for all participants at baseline.|||nanograms/mL||Standard Deviation|Mean
1282005|NCT00249288|Primary|Correlation Between Baseline Blood Folate and MTHFR Genotype|Baseline blood folate lab levels are reported by MTHFR genotype.|Baseline|One participant with CC genotype is missing RBC folate value. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across MTHFR genotype.|||nanograms/mL||Standard Deviation|Mean
1282006|NCT00249288|Primary|Correlation Between Baseline Blood Folate and Smoking Status|Baseline blood folate lab levels are reported by smoking status.|Baseline|1 past smoker and 1 never smoker are missing RBC folate values. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across smoking status.|||nanograms per milliliter||Standard Deviation|Mean
1282007|NCT00249249|Secondary|National Cholesterol Education Program [NCEP]LDL-C Target Attainment|Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)|up to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||Patients|||Number
1282008|NCT00249249|Secondary|Oxidized LDL at 12 Weeks|oxidized low density lipoprotein at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||U/L||Standard Deviation|Mean
1282019|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Month 12|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|12 months|Treated population of participants with a non-index lesion.|||percentage of stenosis|||Number
1282020|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Month 9|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|9 months|Treated population of participants with a non-index lesion.|||percentage of stenosis||Standard Deviation|Mean
1282021|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Week 24|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|24 weeks|Treated population of participants with a non-index lesion.|||percentage of stenosis||Standard Deviation|Mean
1282022|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Week 12|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|12 weeks|Treated population of participants with a non-index lesion.|||percentage of stenosis||Standard Deviation|Mean
1282023|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|12 months|Treated population of participants with an index lesion at this site.|||percentage of stenosis|||Number
1282024|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|9 months|Treated population of participants with an index lesion at this site.|||percentage of stenosis||Standard Deviation|Mean
1282025|NCT00249002|Secondary|Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks|The patency (unblocking) for index lesions is defined as <50% of stenosis and no PFTE graft thrombosis at 24 weeks. The patency for non-index lesions is defined as <50% of stenosis and no new non-index lesions at 24 weeks.|24 weeks|Treated Population of evaluable participants|||percentage of participants|||Number
1282026|NCT00249002|Secondary|Kaplan Meier Estimates for Time to Graft Failure or Intervention|The time to graft failure or intervention was defined as the time from first dose of study drug to the first time graft failure or intervention. Participants who did not have graft failure or intervention at the end of the study were censored at the last known time that the participant had angiography.|up to 12 months|Treated population|||weeks||95% Confidence Interval|Median
1282027|NCT00249002|Secondary|Participants With Arthrosclerotic Cardiovascular Complications|Counts of participants who had treatment-emergent arthrosclerotic cardiovascular complications, specifically myocardial infarction, arterial thromboses, or cerebrovascular events.|up to week 25|Treated population|||participants|||Number
1282028|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|24 weeks|Treated population of participants with an index lesion at this site.|||percentage of stenosis||Standard Deviation|Mean
1282029|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|12 weeks|Treated population of participants with an index lesion at this site.|||percentage of stenosis||Standard Deviation|Mean
1282030|NCT00249002|Primary|Percentage of Participants Without Graft Failure or Need for Intervention|Graft failure is defined as graft thrombosis, loss of vascular access function, or >50% stenosis of the index lesion at the time of a regularly scheduled angiographic assessment.|24 weeks|Evaluable participants who were treated|||percentage of participants|||Number
1282031|NCT00249002|Primary|Percentage of Participants With Discontinued, Delayed or Interrupted Therapy|Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.|up to week 21|Treated population|||percentage of participants|||Number
1282032|NCT00248833|Secondary|Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion|Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion|26 weeks|Number of participants analyzed represents subjects who experienced increases from baseline|||% of subjects|||Number
1282033|NCT00248833|Secondary|Weeks to Serconversion|Weeks to seroconversion evaluated by serum bactericidal assay. Immunogenicity was determined by assessing the number of subjects, in each cohort, who seroconverted. Seroconversion was defined as a 4-fold or greater increase in serum bactericidal antibodies against the vaccine strain. The geometric mean bactericidal titer (GMT) for each group was determined prior to vaccination and at 2 weeks after each vaccination. For each group, the GMT ratio relative to baseline and after 1, 2, or 3 vaccinations and the 95% 2-sided confidence interval was determined. A seroconversion of ≥50% of the subjects after 2 or more doses would meet the criteria for further vaccine development.|26 weeks|Number analyzed are subjects that seroconverted|||Weeks||Standard Deviation|Mean
1282034|NCT00248833|Primary|Safety: Adverse Event Type Summarized by Dose|Adverse events summarized by type and dose|7 days after each vaccination|Both 25ug groups (1 and 2) were grouped for this analysis as both groups received the same dosage|||Number of AEs|||Number
1282038|NCT00248794|Primary|Independent Living Skills Survey|"Independent Living Skills Survey is a 103 items that assess 12 areas of skills; personal hygiene (6 items), appearance and care of clothing (12 items), care of personal possessions and living space (9 items), food preparation (9 items), care of one's own health and safety (10 items), money management (10 items), transportation (7 items), leisure and recreational activities (13 items), job seeking (6 items), job maintenance (3 items), eating behaviors (9 items), and social interactions (9 items). The items describe relatively specific skills such as washes hair twice a week, and informants indicate how frequently an individual has performed each skill within the past month. The responses are yes (1 point) no (0 points). Scores reports are the average #of yes items/number of total items. Higher scores indicating better functioning."|16 weeks after intake||||units on a scale||Standard Error|Mean
1282039|NCT00248794|Primary|Hopkins Verbal Learning Test- Total Recall Variable|This is measure of verbal learning and memory for immediate recall. Respondents are read a list of 12 items and asked to repeat once the last item is given. The list if given 3 times. Each time all items are recorded giving a total score ranging from 0 to 36. The score is converted to T-scores (mean of 50 and sd of 10) using the norms in the manual. The data reported are that in T-Scores with higher scores indicating better functioning.|16 weeks post intake assessment||||units on a scale (T-scores)||Standard Deviation|Mean
1282040|NCT00248794|Primary|Continuous Performance Task X/A Version|CPT relative X/A Percentage. This is a task-oriented computerized assessment of attention-related problems. This variable measures the relative sustained attention, and vigilance over the time of the task. Raw performance is standardize using available age and education norms yielding a Standardized Score with a mean of 100. Maximum Standard score is 145 and the minimum is 55 with higher scores reflect better performance.|16 weeks after intake assessment||||units on a scale (standardized units)||Standard Deviation|Mean
1282041|NCT00248794|Primary|Bell Lysaker Emotion Recognition Test|21 Item audio-visual task that measures the ability to recognize affective states in others. Affective states presented include: Happiness, Sadness, Surprise, Disgust, Fear, Anger and No Emotion. The instrument is scored for total correct responses with scores ranging from 0 to 21 with higher scores indicate better overall performance.|16 weeks from intake|Two way ANOVA using baseline and completion of intervention data|||total correct||Standard Deviation|Mean
1282042|NCT00248794|Primary|Wisconsin Card Sort Percent Perseverative Errors (Standard Score)|"This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects density of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance."|16 weeks after intake||||standard score units||Standard Deviation|Mean
1282043|NCT00248781|Secondary|Six-minute Walk (Durability)|Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.|12 months||||m||Standard Deviation|Mean
1282044|NCT00248781|Secondary|Tandem Stance (Durability)|Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.|12 months||||s||Standard Deviation|Mean
1282045|NCT00248781|Secondary|Single Leg Stance With Eyes Open (Durability)|Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.|12 months||||s||Standard Deviation|Mean
1282046|NCT00248781|Secondary|Knee Flexion Strength (Durability)|The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system|12 months||||kg||Standard Deviation|Mean
1282047|NCT00248781|Primary|Six-minute Walk|Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.|6 months|The number of subjects completing 6 month evaluations|||m||Standard Deviation|Mean
1282048|NCT00248781|Primary|Tandem Stance|Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.|6 months|The number of subjects completing 6 month evaluations|||s||Standard Deviation|Mean
1282049|NCT00248781|Primary|Single Leg Stance With Eyes Open|Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.|6 months|The number of subjects completing 6 month evaluations|||s||Standard Deviation|Mean
1282050|NCT00248781|Primary|Knee Flexion Strength|The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system|6 months|Number of subjects completing 6 month evaluations|||kg||Standard Deviation|Mean
1282051|NCT00248781|Secondary|Knee Extension Strength (Durability)|The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system|12 months||||kg||Standard Deviation|Mean
1282052|NCT00248781|Primary|Knee Extension Strength|The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system|6 months|number of subjects completing 6 month evaluations|||kg||Standard Deviation|Mean
1282053|NCT00248651|Secondary|Dyspepsia-Specific Quality of Life|The Nepean Dyspepsia Index (NDI) assessed quality of life. NDI scores are summarized into overall quality of life and 5 subscales: Interference, Knowledge/Control, Eating/Drinking, Sleep Disturbance, Work/Study. The scale consists of 25 items, yielding 5 sub-scales. Range 0-100, higher numbers indicate a greater quality of life.|12 Weeks|The intent-to-treat analysis included all randomized subjects.|||units on a scale||95% Confidence Interval|Mean
1282054|NCT00248651|Secondary|Maximum Tolerated Volume by Nutrient Drink Test|The nutrient drink test for meal-induced satiety had subjects drink 120 ml of ENSURE every four minutes. Satiety scores were measured on a scale graded 0-5 (1, no symptoms; 5, maximum satiety). When a score of 5 was reached, the maximum tolerated volume intake was measured. Abnormal satiety was defined as inability to consume > 800 ml of Ensure.|12 weeks|The intent-to-treat analysis included all randomized subjects.|||ml||Standard Deviation|Mean
1282055|NCT00248651|Secondary|Gastric Emptying Half-Time (T1/2)|The time for half of the ingested solids or liquids to leave the stomach.|12 weeks|The intent-to-treat analysis included all randomized subjects.|||minutes||Standard Deviation|Mean
1282056|NCT00248651|Primary|Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment|The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.|3 weeks through 12 weeks|The intent-to-treat analysis included all randomized subjects.|||percentage of participants|||Number
1282057|NCT00248638|Secondary|Mean Heat Shock Proteins Level, HSP27|Levels of the heat shock protein, HSP27, will be measured in pg/mL from baseline to day 28. Higher levels indicate a higher protein presence.|Baseline, Day 3, Day 7, Day 14, Day 21, Day 28|The number of participants currently hospitalized are included in each time point analysis.|||pg/mL||Standard Deviation|Mean
1282058|NCT00248638|Secondary|Mean Heat Shock Proteins Level, HSP70|Levels of the heat shock protein,HSP70, will be measured in ng/mL from baseline to day 28. Higher levels indicate a higher protein presence.|Baseline, Day 3, Day 7, Day 14, Day 21, Day 28|The number of participants currently hospitalized are included in each time point analysis.|||ng/mL||Standard Deviation|Mean
1282059|NCT00248638|Secondary|Mean Glutathione Level|Glutathione (GSH) levels will be measured in µM (micro moles) from baseline to day 28. Higher levels indicate a higher GSH presence.|Baseline, Day 3, Day 7, Day 14, Day 21, Day 28|The number of participants currently hospitalized are included in each time point analysis.|||µM||Standard Deviation|Mean
1282060|NCT00248638|Primary|Percentage of Patients Who do Not Develop Hospital Infections|Subjects remaining infection-free during the hospitalization.|Current Hospitalization (Up to 6 Months)||||percentage of participants|||Number
1282061|NCT00248638|Primary|Hospital Mortality Rate|Number of participants who died during hospitalization.|Current Hospitalization (Up to 6 Months)||||participants|||Number
1282062|NCT00248625|Secondary|Infectious Complication||Within 7 days of randomization||||Participants|||Number
1282063|NCT00248625|Secondary|Highest Coma Grade of Hepatic Encephalopathy|West Haven Criteria for hepatic encephalopathy (Grade 0 - IV ) is used for participants > 3 year of age. Coma grade IV indicates a participant who is comatose , with no reflexes, is decerebrate and has abnormal EEG changes with very slow delta activity. For participants less than 3 years the Whittington Scale was used. The Whittington scale does not use EEG changes and has only 3 levels, early (grades I and II), Mid (III) with somnolence, stupor, combativeness and Late (IV) for participants who are comatose with absent reflexes and decerebrate or decorticate posturing.|Within 7 days of randomization|All enrolled participants where coma grade could be assessed. Four participants (two in each randomization arm) could not have coma grade assessed during the 7 days after randomization.|||participants|||Number
1282064|NCT00248625|Secondary|Number of Organ Systems Failing||Within 7 days of randomization||||participants|||Number
1282065|NCT00248625|Secondary|Categorized Length of ICU Stay|The length of ICU stay was categorized as number of days in ICU within 7 days of randomization, unless participant either died or received an LTx within this time period. Special categories were created for these cases.|Within 7 days of randomization||||participants|||Number
1282066|NCT00248625|Secondary|Length of Hospital Stay||Randomization to hospital discharge|All participants enrolled in study with hospital stay information, 2 participants (1 in each arm) did not have hospital discharge information.|||days||Inter-Quartile Range|Median
1282067|NCT00248625|Secondary|Cumulative Percent Incidence of Transplantation by 1 Year||Within 1 year of randomization||||percentage of participants|||Number
1282068|NCT00248625|Secondary|Spontaneous Recovery|Survival without liver transplantation|One year following randomization|All participants enrolled in study|||participants|||Number
1282069|NCT00248625|Primary|Survival|Spontaneous survival without transplant plus survival following transplantation|One year following randomization|All participants who were enrolled in the study were included in the survival analysis|||Participants|||Number
1282070|NCT00248612|Secondary|HAM-D Scale|HAM-D (Hamilton Rating Scale for Depression) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The scoring is based on 17 items. Eight of the items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored on a 3 point scale from 0-2 where 0=none or absent and 2= severe. The total scores for the HAM-D can range from 0 to 50. The total scores are interpreted as: 0-7=normal, 8-13=mild, 14-18= moderate, 19-22= severe, and 23+=very severe depression. The higher the score the more severe the participant's depression.|Session 1 (baseline), Session 8 (8 weeks of treatment)||||units on a scale||Standard Deviation|Least Squares Mean
1282071|NCT00248612|Secondary|HAM-A Scale|The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The HAM-A probes 14 parameters each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. total scores can range from 0 to 56.where <17 indicates mild anxiety, 18–24 moderate anxiety and 25–30 severe anxiety. Higher scores reflect more anxiety.|Session 1 (baseline), Session 8 (8 weeks of treatment)||||units on a scale||Standard Deviation|Least Squares Mean
1282072|NCT00248612|Secondary|DASS Stress Subscale Score|DASS (Depression Anxiety Stress Scales) assesses depression, anxiety and stress responses. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The stress subscale was used which assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Stress scores can range form 0-56 with 0-14=normal, 15-18=mild, 19-25=moderate, 26-33=severe. and 34+=extremely severe stress.|Session 1 (baseline), Session 11 (11 weeks of treatment)||||units on a scale||Standard Deviation|Least Squares Mean
1282073|NCT00248612|Secondary|Medication Compliance Rates|The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts.|12 months||||percentage of participants|||Number
1282074|NCT00248612|Secondary|Treatment Completion|The number and percent of participants that completed the treatment in each arm of the study.|12 months||||Participants|||Count of Participants
1282075|NCT00248612|Primary|Number of Participants Abstinent|Abstaining from the consumption of intoxicating beverages.|Session 8 (8 weeks of treatment)||||Participants|||Count of Participants
1282097|NCT00248287|Secondary|Median Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population|||months||95% Confidence Interval|Median
1282076|NCT00248612|Primary|Craving Desire Scale (CDS)|"The Craving Desire Scale (CDS) is a 3-item scale (1. I do want to drink now”, “2. I crave a drink right now”, 3. “I have a desire for a drink right now”) used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol."|1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)||||units on a scale||Standard Deviation|Mean
1282077|NCT00248612|Primary|Clinical Global Impression Scale-S (CGI-S)|"Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time?~(1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms)"|1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)||||units on a scale||Standard Deviation|Mean
1282078|NCT00248612|Primary|Clinical Global Impression Scale-I (CGI-I)|"Global improvement of alcohol dependence: Rate the total improvement in the participant’s alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed?~(1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)"|Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)||||units on a scale||Standard Deviation|Mean
1282079|NCT00248560|Secondary|Toxicity as Measured by Number and Grade of Adverse Events||Every 2 weeks|||||||
1282080|NCT00248560|Secondary|Survival||Every 8 weeks|||||||
1282081|NCT00248560|Secondary|Response Duration||Every 8 weeks|||||||
1282082|NCT00248560|Primary|Response (Complete Response [CR] + Partial Response [PR])|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks until off study||||participants|||Number
1282083|NCT00248547|Secondary|Pharmacokinetic Interaction|To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.|Up to three weeks|||||||
1282084|NCT00248547|Secondary|Effects on Nausea, Appetite and Taste Changes|To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.|Up to three weeks|||||||
1282085|NCT00248547|Secondary|Safety in Transplant Population|To assess the safety of aprepitant in the bone marrow transplant population|Up to three weeks|||||||
1282086|NCT00248547|Primary|Number of Emesis Free Participants During the Study Period.|To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period|Up to three weeks||||Participants|||Number
1282087|NCT00248534|Secondary|6-month Progression-free Survival|"Scan at 6 months~Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks~Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression"|6 months||||percentage of participants||95% Confidence Interval|Number
1282088|NCT00248534|Secondary|1 Year Overall Survival Rate||1 year||||percentage of participants||95% Confidence Interval|Number
1282089|NCT00248534|Secondary|Number of Participants Alive at 3 Years|The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead.|3 years|One patient died prematurely, one patient withdrew consent before first scan (during induction), 13 patients came off study due to progression of disease.|||Participants|||Count of Participants
1282090|NCT00248534|Primary|Percentage of Participants With Objective Response|Objective response rate of the combination of Rituximab and TMZ|2 months|2 patients were not evaluable, one died prematurely and the other withdrew consent before the first scan (during induction cycle)|||percent of participants||95% Confidence Interval|Number
1282091|NCT00248495|Secondary|Percent Change in SUV Level Between Pre and Post Chemotherapy|Percent change of PET/SUV levels between baseline and post-chemotherapy.|Baseline and post-chemotherapy|All treated and eligible patients|||Percentage change in SUV level||Standard Deviation|Mean
1282092|NCT00248495|Secondary|Correlation Between Response and Markers Such as Presence or Absence of ERCC1 and DHFR, TS, DPD and GARFT||1 year|No participants were analyzed as there was no budget left to do the analysis.||||||
1282093|NCT00248495|Secondary|Disease Free Survival|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions. Disease Free Survival was defined as time from date of treatment initiation until date of first documented progression or date of death from any cause, whichever came first.|At least every 3 months after the completion of adjuvant therapy for two years and thereafter every 6 months for 3 years and then yearly up to 126 months|All treated and eligible patients|||months||95% Confidence Interval|Median
1282094|NCT00248495|Secondary|Overall Survival|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|Every 6 months until the time of death up to 126 months|All treated and eligible patients|||months||95% Confidence Interval|Median
1282095|NCT00248495|Secondary|Number of Participants With Adverse Events|Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Please refer to the adverse event reporting for more detail.|1 year|All treated and eligible patients|||Participants|||Count of Participants
1282096|NCT00248495|Primary|Pathologically Complete Response|Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor.|1 year|ll treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1282098|NCT00248287|Secondary|Median Time of Progression-free Survival (PFS)|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|2 years|ITT population|||months||95% Confidence Interval|Median
1282099|NCT00248287|Secondary|Duration of Response|"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|||months||Full Range|Median
1282100|NCT00248287|Primary|Objective Response Rates (ORR)|To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|Evaluable population|||Percentage of Participants||95% Confidence Interval|Number
1282101|NCT00248170|Secondary|Percentage of Participants Who Experienced Cardiovascular Events|The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.|84 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.|||Percentage of participants|||Number
1282102|NCT00248170|Secondary|Percentage of Participants Who Experienced Clinical Fracture Events|The incidence of clinical fractures was analyzed.|84 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.|||Percentage of participants|||Number
1282103|NCT00248170|Secondary|Change From Baseline in Serum Lipid Profiles|Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.|baseline, 6, 12, 24, 36, 48 and 60 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.|||mg/dL||95% Confidence Interval|Mean
1282104|NCT00248170|Secondary|Distant Disease-free Survival|Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
1282105|NCT00248170|Secondary|Time to Development of Contra Lateral Breast Cancer|Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
1282106|NCT00248170|Secondary|Time to Development of Distant Metastases|Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
1282107|NCT00248170|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
1282108|NCT00248170|Primary|Disease Free Survival|Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
1282109|NCT00247962|Secondary|Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline|ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a “Yes” (scored as 1) or “No” (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).|Baseline and 16 Weeks|The analysis population was limited to subjects whose native language was English, Hungarian and Dutch.|||units on a scale||Standard Deviation|Mean
1282110|NCT00247962|Primary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|16 weeks|All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy evaluation. Last observation carried forward approach (LOCF) used for missing data imputations.|||participants|||Number
1282111|NCT00247676|Secondary|Plasma Concentration of Soluble KIT (sKIT)|Plasma concentrations of sKIT that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||pg/mL||Full Range|Median
1282112|NCT00247676|Secondary|Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)|Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||pg/mL||Full Range|Median
1282113|NCT00247676|Secondary|Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2)|Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline). Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||pg/mL||Full Range|Median
1282114|NCT00247676|Secondary|Plasma Concentration of VEGF-C|Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||pg/mL||Full Range|Median
1282115|NCT00247676|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of VEGF that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by e nzyme-linked immunosorbent assay (ELISA). Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||picograms (pg)/mL||Full Range|Median
1282116|NCT00247676|Secondary|Tissue Tumor Markers Assessed by Tumor Biopsy|Provision of previously collected tumor paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block) for correlative laboratory analysis was optional. For all subjects showing OR on study, it was highly recommended to provide previously collected paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block). These samples were to be analyzed for markers that may be associated with tumor proliferation or angiogenesis.|Day 28 of Cycle 1 (optional)|ITT. Tumor biopsy results were collected optionally in 5 subjects; however, no evaluations were performed.|||intensity score||Standard Deviation|Mean
1282117|NCT00247676|Secondary|Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs)|Blood samples for the assessment of CECs and circulating CEPs were planned to be obtained for subjects in Part 1 of the study, and for a subset of subjects in Part 2 of the study to complete the angiogenic profile of unresectable hepatocellular carcinoma, in addition to the soluble protein evaluation.|Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1)|ITT. Blood samples for CECs and CEP cells were collected during the study, but evaluations of these samples were not performed.|||cells/mL||Standard Deviation|Mean
1282118|NCT00247676|Secondary|Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
1282119|NCT00247676|Secondary|Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib)|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
1282120|NCT00247676|Secondary|Dose-Corrected Ctrough of Sunitinib|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
1282121|NCT00247676|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
1282122|NCT00247676|Secondary|Ctrough of SU-012662 (Metabolite of Sunitinib)|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
1282123|NCT00247676|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|Pharmacokinetic (PK) = All subjects enrolled in the study who at least 1 PK sample collected.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
1282124|NCT00247676|Secondary|1-Year Survival Probability|Probability of survival 1 year after the first dose of study treatment.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year.|ITT|||Probability|||Number
1282125|NCT00247676|Secondary|Overall Survival (ITT Child Pugh Class A Subject Population)|Time from the date of first dose of study medication to the date of death due to any cause.|From start of study treatment until death.|ITT Child Pugh Class A (assessment of liver function) subject population|||Weeks||95% Confidence Interval|Median
1282126|NCT00247676|Secondary|Overall Survival (Overall ITT)|Time from the date of first dose of study medication to the date of death due to any cause.|From start of study treatment until death.|ITT|||Weeks||95% Confidence Interval|Median
1282127|NCT00247676|Secondary|Time to Tumor Progression (ITT Child Pugh Class A Subject Population)|Time from the start of study treatment to the first documentation of objective tumor progression.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT Child Pugh Class A (assessment of liver function) subject population|||Weeks||95% Confidence Interval|Median
1282128|NCT00247676|Primary|Objective Response (CR or PR)|Number of patients with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in patients with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT|||participants|||Number
1282129|NCT00247676|Secondary|Time to Tumor Progression (Overall ITT)|Time from the start of study treatment to the first documentation of objective tumor progression.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT|||Weeks||95% Confidence Interval|Median
1282130|NCT00247676|Secondary|Progression-Free Survival (ITT Child Pugh Class A Subject Population)|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT Child Pugh Class A (assessment of liver function) subject population = subjects enrolled in the study with Child-Pugh Class A that received at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
1282131|NCT00247676|Secondary|Progression-Free Survival (Overall ITT)|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT|||Weeks||95% Confidence Interval|Median
1282132|NCT00247676|Secondary|Best Overall Response of PR or SD With Duration ≥12 Weeks|Number of patients with best overall response of PR or SD with duration ≥ 12 weeks. Best overall response was defined as the time from the first documentation of tumor response that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks or death due to cancer|ITT|||participants|||Number
1282133|NCT00247676|Secondary|Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks)|Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR, or SD for at least 12 weeks on study according to RECIST. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks on study|ITT|||participants|||Number
1282134|NCT00247676|Primary|Best Overall Response|Number of subjects with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ≥ 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of ≥ 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|Intent-to-treat (ITT) population includes all patients enrolled in the study that received at least 1 dose of study medication.|||participants|||Number
1282135|NCT00247676|Secondary|Duration of Objective Response (CR or PR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death due to cancer|From the Overall ITT population, only 1 subject had Objective Response for evaluation of duration of objective response.|||Weeks|||Number
1282136|NCT00247624|Secondary|Insomnia Severity Index (ISI)|The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score, range 0-28. Lower scores represent better outcomes. Total score categories: 0–7 = No clinically significant insomnia, 8–14 = Subthreshold insomnia, 15–21 = Clinical insomnia (moderate severity), 22–28 = Clinical insomnia (severe).|9 weeks||||units on a scale||Standard Deviation|Mean
1282137|NCT00247624|Primary|Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Q-LES-Q is scored from 0-100, with higher scores better than lower. Measured weekly for 9 weeks. Reported as mean of 9 weeks.|9 weeks||||units on a scale||Standard Deviation|Mean
1282138|NCT00247624|Primary|Relation to Self/Others (RSO) Basis-32 Subscale Ratings|"The BASIS 32 psychometric includes several subscales, including relation to self and others (RSO). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension. Measured weekly for 9 weeks. Reported as mean of 9 weeks."|9 weeks||||units on a scale||Standard Deviation|Mean
1282139|NCT00247624|Primary|Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings|"The BASIS 32 psychometric includes several subscales, including daily living and role functioning (DLRF). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension and lower scores denoting better outcomes. Measured weekly for 9 weeks. Reported as mean of 9 weeks."|9 weeks||||units on a scale||Standard Deviation|Mean
1282140|NCT00247611|Post-Hoc|Percentage of Participants Unemployed and on Disability||Data collected at Baseline||||percentage of participant|||Number
1282141|NCT00247611|Primary|Visual Analog Scale Measure of Adherence to ART|"This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one’s regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated.~See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77"|Measured at each clinical visit over 18 months of participation|Intent to treat included all participants with >=2 adherence assessments; OP sample further restricted this sample to those with >=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparisons replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.|||percent with 100% adherence|||Number
1282142|NCT00247611|Secondary|Viral Load Count|Viral load data extracted from medical records beginning 30 days prior to baseline.|Measured over 18 months||||percentage with undetectable viral load|||Number
1282162|NCT00247273|Secondary|Percent Change From Baseline in Serum BAP at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 6|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
1282163|NCT00247273|Secondary|Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population|ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 6|ITT|||ug / L||95% Confidence Interval|Least Squares Mean
1282143|NCT00247611|Primary|AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken|"This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained.~See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee & adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266."|Measured at each clinical care visit over 18 months of participation|Intent to treat included all participants with >=2 adherence assessments; OP sample further restricted this sample to those with >=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparison replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.|||percent with 100% adherence|||Number
1282144|NCT00247416|Secondary|Progression-free Survival|progression-free survival|Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days||||days||95% Confidence Interval|Median
1282145|NCT00247416|Secondary|Effect of Dexamethasone Pre-treatment on Overall Survival.|Overall survival|Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days||||days||95% Confidence Interval|Median
1282146|NCT00247416|Primary|Percentage of Participants With Reduction in Grade 3/4 Neutropenia|Reduction grade 3/4 neutropenia|continuous throughout treatment, up to 25 weeks||||percentage of participants|||Number
1282147|NCT00247416|Secondary|Effect of Dexamethasone Pre-treatment on Response Rate.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment||||percentage of responders out of total||95% Confidence Interval|Number
1282148|NCT00247377|Secondary|Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation|change in quality of life survey response for mental health using the SF-36 questionnaire where 0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
1282149|NCT00247377|Secondary|Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for the emotional role using the SF-36 questionnaire where 0 corresponds to no emotional role and 100 corresponds to full emotional role|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
1282150|NCT00247377|Secondary|Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for social functioning as measured using the SF-36 questionnaire where 0 corresponds to no social functioning and 100 corresponds to full social functioning|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
1282151|NCT00247377|Secondary|Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for vitality as measured using the SF-36 questionnaire with worst score being 0 and best score being 100 on a 1-100 point scale.|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
1282152|NCT00247377|Secondary|Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for general health using the SF-36 questionnaire where 0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
1282153|NCT00247377|Secondary|Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for bodily pain using the SF-36 questionnaire where 0 corresponds to no bodily pain and 100 corresponds to complete bodily pain|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
1282154|NCT00247377|Secondary|Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for physical aspects of life using the SF-36 questionnaire where 0 corresponds to no Role-Physical and 100 corresponds to full Role-Physical|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
1282155|NCT00247377|Secondary|Cost of Procedure to the Medical Facility on Date of Procedure|operative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point: date of surgery.|date of surgery||||dollars per patient||Standard Deviation|Mean
1282156|NCT00247377|Primary|Excess Weight Loss From Pre-operation to 5 Years Post-operation|weight loss as measured by change in percent of excess body weight|Baseline to 5 years|Availability of subjects and protocol design|||percent change||Standard Deviation|Mean
1282157|NCT00247377|Secondary|Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response where 0 is non-functioning and 100 is fully functioning|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
1282158|NCT00247273|Secondary|Number of Participants With New Vertebral Fracture at Month 24, ITT Population|At least 1 new fractured vertebra|Baseline to Month 24|ITT|||Participants|||Number
1282159|NCT00247273|Secondary|Number of Participants With New Vertebral Fracture at Month 12, ITT Population|At least 1 new fractured vertebra|Baseline to Month 12|ITT|||Participants|||Number
1282160|NCT00247273|Secondary|Percent Change From Baseline in Serum BAP at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 24|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
1282161|NCT00247273|Secondary|Change From Baseline in Serum BAP at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 24|ITT|||ug / L||95% Confidence Interval|Least Squares Mean
1282168|NCT00247273|Secondary|Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 24|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
1282169|NCT00247273|Secondary|Change From Baseline in Urine NTX/Cr at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 24|ITT|||nmol BCE / mmol Creatinine||95% Confidence Interval|Least Squares Mean
1282170|NCT00247273|Secondary|Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 6|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
1282171|NCT00247273|Secondary|Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine|Baseline to Month 6|ITT|||nmol BCE / mmol Creatinine||95% Confidence Interval|Least Squares Mean
1282172|NCT00247273|Secondary|Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 24|ITT|||g/cm^2||95% Confidence Interval|Least Squares Mean
1282173|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 24|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
1282174|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).|Baseline to Month 24 - Endpoint|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1282175|NCT00247273|Secondary|Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 12|ITT|||g/cm^2||95% Confidence Interval|Least Squares Mean
1282176|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1282177|NCT00247273|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).|Baseline to Month 12 - Endpoint|ITT (intent to treat) Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1282178|NCT00246805|Primary|Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)|Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.|June 2009||||participants|||Number
1282179|NCT00246805|Secondary|Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization||January 2009|||||||
1282180|NCT00246805|Secondary|Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate||January 2009|||||||
1282181|NCT00246805|Secondary|Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation||January 2009|||||||
1282182|NCT00246805|Secondary|Evaluation of Rate Irregularity Indicators and Patient's Symptoms||January 2009|||||||
1282183|NCT00246753|Secondary|Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)|To assess the correlation between expression of molecular markers and patient response to treatment with GW572016|4 years|Data were not collected.||||||
1282184|NCT00246753|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.|4 years||||days||95% Confidence Interval|Median
1282185|NCT00246753|Primary|Number of Patients Experiencing Decline in Prostate-specific Antigen|Determine the number of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.|4 years||||Participants|||Count of Participants
1282186|NCT00246740|Secondary|Venous Plasma Concentration of IL-6|Measurement of inflammation marker interleukin-6 in plasma|Before surgery and up to 72 h reperfusion after surgery||||pg/ml||Standard Error|Mean
1282187|NCT00246740|Secondary|Venous Plasma Concentration of C-reactive Protein|Measurement of inflammation marker C-reactive protein in plasma|Before surgery and up to 72 h reperfusion after surgery||||ng/ml||Standard Error|Mean
1282188|NCT00246740|Secondary|Cleaved TroponinI/GAPDH Ratios in Right Atrial Biopsy|Measurement of the ratios of cleaved TnI (troponin-I) versus GAPDH in biopsies collected from right atria. Measure is the ratio TnI/GAPDH|Before surgery and 10 minutes reperfusion after surgery||||Arbitrary units-Cleaved TnI/GAPDH||Standard Error|Mean
1282189|NCT00246740|Secondary|Venous Plasma Concentration of Troponin-I|Measurement of levels of TnI (troponin-I), a marker of cardiac cell damage|Before surgery and 10 minutes reperfusion after surgery||||pg/ml||Standard Error|Mean
1282190|NCT00246740|Secondary|Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion|Biochemical activity of MMP-2 activity in venous plasma, measured before surgery and up to 72h of reperfusion after surgery.|Before surgery and up to 72 h reperfusion after surgery||||Arbitrary units||Standard Error|Mean
1282191|NCT00246740|Secondary|Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion|Biochemical activity of MMP-9 activity in venous plasma, measured before surgery and up to 72h of reperfusion after surgery.|Before surgery and up to 72 h reperfusion after surgery||||Arbitrary units||Standard Error|Mean
1282192|NCT00246740|Secondary|Cardiac Matrix Metalloproteinase-2 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion|Biochemical activity of MMP-2 activity in right atrial biopsies, measured at 10 minutes of reperfusion after surgery.|Before surgery and 10 minutes reperfusion after surgery||||Arbitrary units||Standard Error|Mean
1282193|NCT00246740|Secondary|Cardiac Matrix Metalloproteinase-9 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion|Biochemical activity of MMP-9 activity in right atrial biopsies, measured at 10 minutes of reperfusion after surgery. To determine MMP-9 activity, 20 μg of total protein from both myocardial extracts and plasma were analyzed by gelatin zymography. For detailed methodology consult Cheung PY, Sawicki G, Wozniak M, et al: Matrix metalloproteinase-2 contributes to ischemia-reperfusion injury in the heart. Circulation 2000; 101:1833–1839|Before surgery and 10 minutes reperfusion after surgery||||Arbitrary units||Standard Error|Mean
1282194|NCT00246740|Primary|Left Ventricular Stroke Work Index (LVSWI)|Measure of global left ventricular function. The formula used for calculation is: LVSWI= SI x MAP x 0.0144 LVSWI = Left Ventricular Stroke Work Index (g*m/m2) SI = Stroke Index (mL/beat/m2) MAP = Mean Arterial Pressure (mmHg) 0.0144 is a conversion term to equalize units.|Before surgery up to 24h of reperfusion||||g*m/m2||Standard Error|Mean
1282195|NCT00246571|Secondary|Circulating Tumor Cells (CTC)|Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs|Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||cells/7.5 mL||Standard Deviation|Mean
1282196|NCT00246571|Secondary|Circulating Endothelial Cells (CEC)|Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.|Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||cells/mL||Standard Deviation|Mean
1282197|NCT00246571|Secondary|Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor|Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||pg/mL||Standard Deviation|Mean
1282198|NCT00246571|Secondary|Plasma Concentration of Soluble Placental Growth Factor (sPlGF)|Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||pg/mL||Standard Deviation|Mean
1282199|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)|Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||pg/mL||Standard Deviation|Mean
1282200|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)|Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||pg/mL||Standard Deviation|Mean
1282201|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)|Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. This outcome measure was not analyzed.|||pg/mL||Standard Deviation|Mean
1282202|NCT00246571|Secondary|Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)|Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
1282203|NCT00246571|Secondary|Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)|Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
1282204|NCT00246571|Secondary|Dose-corrected Ctrough of Sunitinib|Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
1282205|NCT00246571|Secondary|Ctrough of Total Drug (Sunitinib + SU012662)||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
1282206|NCT00246571|Secondary|Ctrough of SU012662 (Metabolite of Sunitinib)||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
1282207|NCT00246571|Secondary|Observed Plasma Trough Concentrations (Ctrough) of Sunitinib||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
1282259|NCT00246025|Secondary|Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)|Number of Participants expressing DVT with symptoms|2 weeks|FAS−op - FAS−op includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.|||Percentage of participants|||Number
1282208|NCT00246571|Secondary|HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal|This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.|||score on a scale|||Number
1282209|NCT00246571|Secondary|Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)|EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal|This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.|||score on a scale|||Number
1282210|NCT00246571|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (up to 3 years after first dose of study medication)|ITT population|||months||95% Confidence Interval|Median
1282211|NCT00246571|Secondary|Survival Probability at 1 Year|Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.|Baseline until death (up to 3 years after first dose of study medication)|ITT population|||ratio||95% Confidence Interval|Number
1282212|NCT00246571|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Time from first response to disease progression up to 3 years from first dose|ITT population|||months||95% Confidence Interval|Median
1282213|NCT00246571|Secondary|Proportion of Participants With Objective Response|Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.|Baseline until response or disease progression (up to 3 years from first dose)|ITT population|||percentage of participants||95% Confidence Interval|Number
1282214|NCT00246571|Primary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)|Intent-to-Treat (ITT) population: all participants who were randomized.|||Months||95% Confidence Interval|Median
1282215|NCT00246519|Secondary|Adverse Metabolic Responses||9-18 weeks of treatment|||||||
1282216|NCT00246519|Primary|Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)).||baseline to 18 weeks of treatment|A total 768 patients had at least monotherapy response data. Of the 386 patients assigned to the atenolol arm, 357 completed both drugs. Of the 382 assigned to the HCTZ arm, 355 completed both drugs. The delta blood pressure below is for patients who completed both drugs.|||mmHg||Standard Deviation|Mean
1282217|NCT00246441|Primary|Drinking to Cope|Drinking days that were related to coping with Social Anxiety determined by the TLFB- the proportion of drinking days that were reported to be due to coping with social anxiety. Minimum value is 0, maximum value is 1 Higher is worse.|16 weeks treatment||||proportion of drinking days||Standard Error|Mean
1282218|NCT00246441|Primary|Alcohol Use, Quantity and Frequency|Timeline Followback (TLFB), a validated calendar based instrument to assess number of standard drinks consumed on each day of the trial. Baseline measures were computed using past 30 days. From the TLFB, three measures were computed: 1. Proportion of days abstinent (PDA) (the number of days when no drinking occurred, divided by the number of days in the assessment period) (minimum is 0, maximum is 1) (higher score is better), 2. Drinks per drinking day (DDD) (the mean number of standard drinks consumed on a drinking day in the assessment period) (minimum is >0, maximum is infinity) (higher score is worse), 3. Proportion of Heavy Drinking Days (PHD) (the proportion of days each assessment period that a woman consumed 4 or more standard drinks/ man consumed 5 or more standard drinks) (minimum is 0, maximum is 1) (higher score is worse).|16 weeks treatment||||units on a scale||Standard Error|Mean
1282219|NCT00246441|Primary|Social Anxiety Severity|Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.|16 weeks treatment||||units on a scale||Standard Deviation|Mean
1282220|NCT00246376|Primary|Total Cholesterol : HDL-C Ratio|Total cholesterol : HDL-C ratio: Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||ratio||Standard Error|Mean
1282221|NCT00246376|Primary|Total Cholesterol|Total cholesterol (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||mg/dL||Standard Error|Mean
1282222|NCT00246376|Primary|HDL-C|HDL-C (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||mg/dl||Standard Error|Mean
1282227|NCT00246337|Secondary|Sustained Pain Freedom|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.|2-24 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."|||Participants|||Number
1282228|NCT00246337|Secondary|Sustained Pain Relief|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.|2-24 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing"|||Participants|||Number
1282229|NCT00246337|Secondary|Pain Freedom at 2 Hours|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.|2 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."|||Participants|||Number
1282230|NCT00246337|Primary|Pain Relief at 2 Hours|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.|2 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."|||Participants|||Number
1282231|NCT00246324|Secondary|Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay||8 months|||||||
1282232|NCT00246324|Secondary|Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline||8 months|||||||
1282233|NCT00246324|Secondary|Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes|Only 1 patient relapsed. Correlations between decrease serum metalloproteinase 9 levels and enhancing lesion activity reduction. Transendothelial migration of monocytes was suppressed. Adverse effects were mild. No adverse synergistic effects of combination therapy.|8 months||||participants|||Number
1282234|NCT00246324|Primary|Gadolinium-enhancing (Gd+)Lesion Number Change.|Before treatment is the number of lesions per image from months -3, -2, -1, and 0. During treatment is the number of lesions from months 1,2, and 3. The mean number of Gd+ lesions during each treatment period was calculated for each patient as the total number of Gd+ lesions observed across all images divided by the number of images. Hence, the mean number of Gd+ lesions per patient represents the number of lesions per MRI.|8 months||||Gd+ lesions||95% Confidence Interval|Median
1282235|NCT00246259|Other Pre-specified|Abnormal Involuntary Movement Scale (AIMS)|The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none, 4=severe). Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dental status. Total scores range from 0 to 42 with higher values indicating more severity.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.|||Units on a scale||Standard Deviation|Mean
1282236|NCT00246259|Other Pre-specified|Simpson Angus Scale (SAS)|The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The 10 items are rated on a 5-point scale (0=complete absence, 4=extreme presence) after a brief neurological examination and observation of the participants’ gait (slow, shuffling walk). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.|||Units on a scale||Standard Deviation|Mean
1282237|NCT00246259|Other Pre-specified|Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment|The BARS evaluates akathisia (feeling of restlessness) associated with the use of antipsychotic medications, including an objective and a subjective component plus a global impression. Components are rated on a scale of 0 (normal or absence of restlessness)-3 (intense restlessness) and 0 (absent)-5 (severe akathisia) for the global clinical assessment. Number of participants in each global clinical assessment scale are reported.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.|||Participants|||Number
1282260|NCT00246025|Secondary|Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period|Number of participants who have Proximal DVT during treatment period|2 weeks|FAS−pDVT - FAS−pDVT includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT.|||percentage of participants|||Number
1282261|NCT00246025|Secondary|Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality|Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality|2 weeks|FAS-major - FAS-major includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT, PE, or VTE-related death.|||percentage of participants|||Number
1282238|NCT00246259|Secondary|Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV|The SF-36 is a survey of participant health. It calculates two standardized scales: the standardized mental component scale and the standardized physical component scale. The standardized scales are calculated as weighted sums of the 8 scores, which are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range; and standardized mental component scale score is calculated as weighted average of individual item scores on a 0-100 range, where 100 signify highest level of functioning. The change from baseline in mental component scale score was reported.|Up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1282239|NCT00246259|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV|The DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1282240|NCT00246259|Secondary|Total Words Score Over Time|Controlled Word Association Test (COWAT) was used to assess verbal fluency. Participants are given 3 different letters of the alphabet and asked to say as many words beginning with each letter within a controlled time. Participants are then asked to identify as many words as possible in 3 different categories (animals, fruits and vegetables) within a specified period of time. The total score is a sum of all three categories scores. The total score ranges from 0-90, the higher the score the higher the verbal fluency.|Baseline, Week 104 or LRV|The ITT population:all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' signifies participants evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.|||Units on a scale||Standard Deviation|Mean
1282241|NCT00246259|Secondary|Number of Participants With Cognitive Assessments Using Trail B|Cognitive assessments were done using Trail test B, which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. In Trail B, 2 sets of circles contain numbers and letters, and the participant must connect them in alternating order. Trail B is also a measure of executive functions as it requires planning and decision-making.|Week -2, 104 or LRV|The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.|||Participants|||Number
1282242|NCT00246259|Secondary|Number of Participants With Cognitive Assessment Using Trail A|Cognitive assessments were done using Trail test A which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. Participants must connect numbered circles in a variety of orders.|Week -2, 104 or LRV|The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.|||Participants|||Number
1282243|NCT00246259|Secondary|Percentage of Participants With Relapse|"Relapse was defined according to Csernansky: “Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as CGI-C score of 6 (much worse)."|Week 10 (post-stability) up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) = participants evaluable for this measure.|||Percentage of participants|||Number
1282244|NCT00246259|Secondary|Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV|The HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom. Total score ranges from 0 to 56. Lower score indicates less affected.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1282245|NCT00246259|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV|Co-morbid symptoms of mania are evaluated by change in YMRS Score which is an 11-item scale to assess symptoms of mania, Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (the least) to 60 (the worst).|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1282262|NCT00246025|Primary|Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.|number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality|2 weeks study medication|Full analysis set (FAS) - Full analysis set includes all patients who were randomly assigned to the treatment, received at least one oral dose, went through surgery, had an evaluable venogram for distal and proximal DVT, or had confirmed symptomatic DVT or PE, or died.|||percentage of participants|||Number
1282246|NCT00246259|Secondary|Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV|Co-morbid depressive symptoms are evaluated by change in CDSS Score which was developed to assess symptoms of depression in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). It consists of 9 items, each scored from 0 (absent) to 3 (severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1282247|NCT00246259|Primary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV|The SOFAS focused exclusively on participants’ level of social and occupational functioning. The SOFAS is a 100 point single item scale that rates functioning of a participant. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1282248|NCT00246259|Primary|Time to Relapse|"Time to relapse was calculated from the start of the maintenance phase to date of relapse according to Csernansky: “Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as Clinical Global Impression of Change (CGI-C) score of 6 (much worse)."|Week 10 (post-stability) up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment.|||Weeks||Standard Deviation|Mean
1282249|NCT00246259|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline, Week 104 or LRV|Intent-to-treat (ITT) analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. One participant was missing as reported in oral antipsychotic arm. 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1282250|NCT00246090|Secondary|Duration of Response|Complete response (CR) is defined as the disappearance of all lesions. Partial response (PR) is defined as 30% decrease in lesion diameter.|From first documented complete or partial response until disease progression or death|Eligible Population|||Days||Full Range|Median
1282251|NCT00246090|Primary|Objective Response Rate|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Every two cycles|Eligible Population|||Percentage of Participants|||Number
1282252|NCT00246025|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study||||participants|||Number
1282253|NCT00246025|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 0|Safety set|||mL||Standard Deviation|Mean
1282254|NCT00246025|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 0|Safety set|||participants|||Number
1282255|NCT00246025|Secondary|Number of Participants With Bleeding Events During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|2 weeks|Safety set - Safety set includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.|||participants|||Number
1282256|NCT00246025|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee.|2 weeks|FAS−op|||percentage of participants|||Number
1282257|NCT00246025|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.|2 weeks|FAS−op|||percentage of participants|||Number
1282258|NCT00246025|Secondary|Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period|Number of participants who have Total DVT during treatment period|2 weeks|FAS−tDVT - FAS−tDVT includes all patients who were randomised, treated, operated, and had evaluable venogram or confirmed symptomatic DVT.|||percentage of participants|||Number
1282596|NCT00242567|Secondary|Skeletal-related Event(SRE)-Free Survival|Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.|36 months|The ITT Population consisted of all patients randomized to treatment.|||Days||95% Confidence Interval|Median
1282263|NCT00246012|Other Pre-specified|Percentage of Participants Who Achieved a Best Overall Response as CR, PR, or SD - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50% or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure.|Within 28 days of first infusion of study medication, within 1 week of the end of Cycles 2, 4, 6, 8; 3 months and 6 months post-last dose of study medication|The response-evaluable population included all the participants who were evaluable for response.|||Percentage of Participants|||Number
1282264|NCT00246012|Other Pre-specified|Area Under the Concentration Versus Time Curve Between Zero to Infinite Time (AUCinf) of Intetumumab - Phase 1 (Part 1)|The AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcg*day/mL||Standard Deviation|Mean
1282265|NCT00246012|Secondary|Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 2)|The R is obtained by dividing AUC at two different time points.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.||||||
1282266|NCT00246012|Secondary|Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 2)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/kg||Standard Deviation|Mean
1282267|NCT00246012|Secondary|Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 2)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/day/kg||Standard Deviation|Mean
1282268|NCT00246012|Secondary|Half-life of Intetumumab - Phase 1 (Part 2)|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
1282269|NCT00246012|Secondary|Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2)|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcg*day/mL||Standard Deviation|Mean
1282270|NCT00246012|Secondary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2)|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1282271|NCT00246012|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2|The BPI questionnaire is used to evaluate heath related quality of life. BPI allows participants to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).|Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)|The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1282272|NCT00246012|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2|The FACT-MS subscale is used to evaluate health related quality of life. It consists of 16 items: 12 items related to physical well-being, 3 to emotional well-being and 1 to social well-being. Scores for all items will range from 0 to 4. Total score ranges from 0-64; higher score indicates a more positive quality of life.|Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)|The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1282273|NCT00246012|Secondary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.|||mcg/mL||Standard Deviation|Mean
1283179|NCT00232141|Secondary|Change From Baseline for NRS-Sleep Interference Scores|11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain])|Baseline, Week 14|ITT Population|||score on scale||Standard Error|Least Squares Mean
1282274|NCT00246012|Secondary|Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2|Eastern Cooperative Oncology (ECOG) performance status: Participants will be graded from 0 (Fully active, able to carry on all pre-disease activities without restriction) to 4 (Completely disabled, cannot carry on any self-care, totally confined to bed or chair). Worsening in ECOG score was defined as ≥ 1 point increase in ECOG score from baseline.|Baseline (within 7 days of first infusion of study medication), Day 1 of all 8 cycles, 3 weeks or 1 week post-last dose, 3 months and 6 months post-last dose of study medication|The ITT population included all the participants who were randomly assigned to treatment.|||Days||95% Confidence Interval|Median
1282275|NCT00246012|Secondary|Duration of Response - Phase 2|Time duration required to achieve a CR or PR.|From the time of initial documented response (CR or PR) to the first documented sign of progression, assessed up to 6 months post-last dose of study medication|The response-evaluable population included all the participants who were evaluable for response. The results were reported as individual participant’s listings, but not statistically summarized.||||||
1282276|NCT00246012|Secondary|Overall Survival (OS) - Phase 2|The OS is defined as the time from the date of randomization to the date of death due to any cause and was to be censored at the date that the subject is last known to be alive.|Every 3 months until death, until lost to follow-up, until withdrawal of consent, or until the Sponsor ends the study, as assessed up to 6 months post-last dose of study medication|The ITT population included all the participants who were randomly assigned to treatment.|||Days||95% Confidence Interval|Median
1282277|NCT00246012|Secondary|Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2|The SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as a reference the smallest sum longest diameter since the treatment started. The participants who achieved SD as the best response were reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.|||Percentage of Participants|||Number
1282278|NCT00246012|Secondary|Percentage of Participants Who Achieved CR - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions. The participants who achieved CR as the best response were reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.|||Percentage of Participants|||Number
1282279|NCT00246012|Secondary|Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50 percent (%) or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure. The best response achieved among all the evaluated time points was reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.|||Percentage of Participants|||Number
1282280|NCT00246012|Primary|Progression-Free Survival (PFS) - Phase 2|The PFS was defined as the time from the date of randomization to the date of initial documented progressive disease (PD), or the date of initial documented symptomatic deterioration, or the date of death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as a reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions.|From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication|The Intent-to-treat (ITT) population included all the participants who were randomly assigned to treatment.|||Days||95% Confidence Interval|Median
1282281|NCT00246012|Primary|Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1)|The R is obtained by dividing AUC at two different time points.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.||||||
1282282|NCT00246012|Primary|Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/kg||Standard Deviation|Mean
1282283|NCT00246012|Primary|Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/day/kg||Standard Deviation|Mean
1282284|NCT00246012|Primary|Half-life of Intetumumab - Phase 1 (Part 1)|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
1282527|NCT00243386|Secondary|Area Under the Curve|Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||IU*h/dL||Standard Deviation|Geometric Mean
1282285|NCT00246012|Primary|Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1)|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcg*day/mL||Standard Deviation|Mean
1282286|NCT00246012|Primary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1)|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The Pharmacokinetics (PK)-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1282287|NCT00246012|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1|The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.|Up to 21 days post-first infusion from the last treated participant in Phase 1|Safety population included all the participants who received at least 1 (partial or complete) dose of intetumumab/placebo or dacarbazine.|||Participants|||Number
1282288|NCT00245960|Secondary|Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease.|Efficacy measured by the number of subjects achieving Psoriatic Arthritis response criteria at 24 weeks last observed carried forward (LOCF).|24 weeks|The analysis population was the Modified Intent to Treat (mITT).|||participants|||Number
1282289|NCT00245960|Primary|Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis.|Efficacy measured by the number of subjects with a Physician Global Assessment of Psoriasis of clear or almost clear at 12 weeks last observation carried forward (LOCF).|12 weeks|The analysis population was the Modified Intent to Treat (mITT) population.|||participants|||Number
1282290|NCT00245856|Secondary|Bleeding Events|Total major bleeding rate|3 months|All DVT treated patients analyzed together|||participants||95% Confidence Interval|Number
1282291|NCT00245856|Primary|New Venous Thromboembolism at 3 Months|New DVT or PE at 3 months confirmed by diagnostic testing|3 months|All DVT treated patients analyzed together|||participants||95% Confidence Interval|Number
1282292|NCT00245856|Primary|Percentage of Participants That Died at 3 Months||3 months|All DVT treated patients analyzed together|||percentage of participants||95% Confidence Interval|Number
1282293|NCT00245635|Primary|Change in Total Score on the BDD-Y-BOCS Scale|To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.|Baseline compared to the study endpoint (week 12) [two time points]||||units on a scale||Standard Deviation|Mean
1282294|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|"The time to recovery from maximum percent fall is the~duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the~time when FEV1 returns to within 5% of the preexercise baseline for the first time."|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1282295|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose|"The time to recovery from maximum percent fall is the~duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the~time when FEV1 returns to within 5% of the preexercise baseline for the first time."|Exercise challenge at 8.5 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1282296|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1282297|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline|0-60 minutes after the exercise challenge at 24 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||Percent * minutes||Standard Deviation|Mean
1282298|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose|The measure included only the area below the pre-exercise baseline|0-60 minutes after the exercise challenge at 8.5 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||Percent * minutes||Standard Deviation|Mean
1282528|NCT00243386|Secondary|Total Area Under the Curve (AUC)|Total AUC estimated by AUC 0-48h plus an area extrapolated from the log-linear regression model|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||IU*h/dL||Standard Deviation|Geometric Mean
1282299|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose|"The measure included only the area below the pre-exercise~baseline"|0-60 minutes after the exercise challenge at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||Percent * minutes||Standard Deviation|Mean
1282300|NCT00245570|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change from Baseline||Standard Deviation|Mean
1282301|NCT00245570|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose|The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change from Baseline||Standard Deviation|Mean
1282302|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
1282303|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose||0-90 minutes after the exercise challenge performed at 8.5 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
1282304|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
1282305|NCT00245570|Primary|Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change from Baseline||Standard Deviation|Mean
1282306|NCT00245557|Primary|Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)|"The primary outcome is a phosphorus magnetic resonance spectroscopy (31P-MRS) signal quantified using a spectral time-domain fitting program based on the Marquadt-Levenberg non-linear, least-squares algorithm, that incorporates prior knowledge of spectral peak assignments, chemical shifts and J-coupling constants. Least squares means were calculated for average total signal using linear mixed effects models. Results are expressed as a spectroscopic index.~beta-nucleoside triphosphate (bNTP) Phosphocreatine (PCr) Total nucleoside triphosphate (NTP)"|at week 0 for both control and depressed, and at week 12 for depressed||||Spectroscopic Index||Standard Error|Least Squares Mean
1282307|NCT00245557|Primary|Geriatric Depression Scale|This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms).|baseline at study entry week 0|Not all subjects included in MRS analysis had baseline GDS data.|||Units on a scale||Standard Deviation|Mean
1282308|NCT00245557|Primary|HAM-D 17 (Hamilton Depression Rating Scale)|"This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness.~Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms)."|baseline at study entry week 0||||Units on a scale||Standard Deviation|Mean
1282309|NCT00245518|Primary|Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282310|NCT00245518|Primary|Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282311|NCT00245518|Primary|Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282554|NCT00243061|Secondary|Time to Disease Progression||Up to 6 years|9 patients developed progressive disease|||months||95% Confidence Interval|Median
1282312|NCT00245518|Primary|General Health Perceptions as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282313|NCT00245518|Primary|Body Pain as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282314|NCT00245518|Primary|Physical Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282315|NCT00245518|Primary|Fatigue as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282316|NCT00245518|Primary|Physical Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282317|NCT00245518|Primary|Mental Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282318|NCT00245518|Primary|Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)|Hot flashes were assessed using symptom severity 0= none, slight=1, moderate=2, and severe = 3. Hot flashes have a weighting factor of 4 on the overall Blatt-Kuppermann index, making score ranges 0-12, with 12 being the most severe hot flashes.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282319|NCT00245518|Primary|Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)|The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person’s average sleep propensity in daily life (ASP), or their ‘daytime sleepiness’.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282320|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual satisfaction. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very dissatisfied and 10 being very satisfied.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282321|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual desire. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very low or none at all, and 10 representing almost always/very high.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282322|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with orgasm. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 1-10, with a score of 0 indicating that no sexual stimulation or intercourse was attempted in the last 4 weeks, 1= almost never or never ejaculated, 10= almost always or always|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282323|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with intercourse. A score of 0-5 is awarded to each of the 3 questions which refer to the past 4 weeks only. The score rangers from 0-15, with a score of 0 indicating that no intercourse was attempted in the last 4 weeks, 1= almost or little to no sanctification, 15= very highly satisfied.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282324|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. Erectile function is one domain, making up 6 out of 15 questions. The score ranges from 1-30, with the lowest score representing minimal erectile function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282555|NCT00243061|Secondary|Highest Toxicity Grade Assessed by NCI CTCAE Version 3.0||Up to 6 years after completion of treatment||||highest grade|||Number
1282325|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions which refer to the past 4 weeks only. The questions are split into the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The total score ranges from 6-75 with 6 being minimal erectile function and 75 representing maximal erectile function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282326|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification|The domains of satisfaction (3 items), is assessed using a five-point Likert-type scale ranging from “always” to “never” to generate the score, ranging from 3-15. The higher the number, the higher the level of satisfaction with sexual function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282327|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal|The domains of arousal (1 item subscale of the WSFQ), is assessed using a five-point Likert-type scale ranging from “always” to “never” to generate the score for arousal. The higher the number (range 1-5), the more the participant is able to experience arousal.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282328|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function|The domain of erectile function/orgasm consists of 7 items. A five-point Likert-type scale ranging from “always” to “never” is used to generate a score, ranging from 7-35. Higher scores indicate increased erectile function/achievement of orgasm.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282329|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido|The domain of sexual desire/libido consists of 6 items. A five-point Likert-type scale ranging from “always” to “never” is used to generate a score, ranging from 6-30. Higher scores indicate increased libido/sexual desire.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282330|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score|The WSFQ contains 17 items that assess the domains of sexual desire/libido (6 items), arousal (1 item), orgasm/erectile function (7 items), and satisfaction(3 items). A five-point Likert-type scale ranging from “always” to “never” is used to generate a total score and four domain scores. The possible range of total sexual function scores is 17 to 85. Higher scores indicate better sexual function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282331|NCT00245518|Primary|Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall|"The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent’s ability to use cues to retrieve information after 25-30 minutes. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:~Correct Image: placed properly (2 points), placed poorly (1 point)~Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point~Absent or not recognizable: 0 points~Scale ranges 0-36, with 36 representing maximum cognition ."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282332|NCT00245518|Primary|Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall|"The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent’s ability to use cues to retrieve information. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:~Correct Image: placed properly (2 points), placed poorly (1 point)~Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point~Absent or not recognizable: 0 points~Scale ranges 0-36. with 36 being greatest cognitive function."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282333|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops|The GPT assesses eye–hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks||||number of times peg dropped||Standard Deviation|Mean
1282334|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops|The GPT assesses eye–hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks||||number of times peg dropped||Standard Deviation|Mean
1282335|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)|The GPT assesses eye–hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the non-dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks||||time in seconds||Standard Deviation|Mean
1282556|NCT00243061|Secondary|Stable Disease Duration||From the start of the treatment until the criteria for progression are met, assessed up to 6 years|Only 17 of the 24 accrued patients were evaluable for response|||months||95% Confidence Interval|Median
1282336|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)|The GPT assesses eye–hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole. A faster time, indicates greater cognitive functioning.|baseline, 6 weeks, 12 weeks||||time in seconds||Standard Deviation|Mean
1282337|NCT00245518|Primary|Cognitive Function as Assessed by the F-A-S Test|The F-A-S Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (NCCEA), is a measure of phonemic word fluency, which is a type of verbal fluency. It assesses phonemic fluency by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute)|baseline, 6 weeks, 12 weeks||||seconds||Standard Deviation|Mean
1282338|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20–25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives.A higher score= higher cognitive function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282339|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20–25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, & 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score= higher cognitive function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282340|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20–25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, & 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282341|NCT00245518|Primary|Cognitive Function as Assessed by the National Adult Reading Test (NART)|the NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1282342|NCT00245466|Secondary|Serum Levels of Testosterone After 1, 2, and 3 Years||3 years||||nanogram per milliliter||Full Range|Median
1282343|NCT00245466|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).|||participants|||Number
1282344|NCT00245466|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.|||participants|||Number
1282345|NCT00245219|Primary|Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample.|Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.|||units on a scale||Standard Deviation|Mean
1283208|NCT00231478|Primary|Number of Patients With no Vomiting|Number of patients with no vomiting is described as no emesis up to 2 hours after surgery|0-2h after end of surgery (time of extubation)|Evaluable Patients|||participants|||Number
1282346|NCT00245219|Primary|Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Physical Functioning, Bodily Pain, Role Limitations due to Physical Problems and General Health. In the present study, scores ranged from a maximum of 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health).|Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.|||units on a scale||Standard Deviation|Mean
1282347|NCT00245219|Primary|Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).|Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.|||units on a scale||Standard Deviation|Mean
1282348|NCT00245128|Secondary|Reduction in Marrow Fibrosis and Decrease in Spleen Size||After 6 and 12 months of therapy|||||||
1282349|NCT00245128|Primary|Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy|"A major response = transfusion independent or a>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks.~Minor response= > 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period."|At 3,6, and 12 months of therapy||||percentage of participants|||Number
1282350|NCT00245102|Primary|Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST|A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.|Up to 4 weeks||||participants|||Number
1282351|NCT00245063|Primary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 weeks||||percentage of responding patients|||Number
1282352|NCT00245050|Secondary|Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)|QOL was measured with the FACT-G questionnaire following the third course of doxorubicin HCl liposome before the patient was seen by the treating physician and before chemotherapy was administered. The FACT-G, version 4, is a 27-item core questionnaire evaluating the domains of physical, functional, family-social, and emotional well-being (PWB, FWB, SWB, EWB). Total score ranges from 0-108 and higher scores indicate better QOL.|After Cycle 3 of chemotherapy (on average at 3 months)||||Total scores on FACT-G scale||Standard Deviation|Mean
1282353|NCT00245050|Primary|Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)|Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific doxorubicin HCl liposome related toxicities using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.|Patients were evaluable for PPE/HFS(Hand-Foot Syndrome) incidence and toxicity assessment if they received at least one course of chemotherapy. Intention to treat analysis was used.|||participants|||Number
1282354|NCT00245037|Secondary|Chronic Graft-Versus-Host Disease (cGVHD) Outcome|"Grading of Chronic GVHD:~Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD~Extensive:~One or more of the following:~Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer’s test with <5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ~Chronic GVHD Severity:~Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy.~Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy.~Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy"|Years 1, 2 and 3|This is a cumulative incidence of cGVHD at 1 year, 2 years, and 3 years. A total of 99 patients (out of 147) developed cGVHD, 86 patients (87%) with extensive stage cGVHD and 13 patients (13%) with limited stage cGVHD.|||percentage of analyzed participants|||Number
1282355|NCT00245037|Secondary|Acute Graft-Versus-Host Disease (aGVHD) Outcome|"Grading of Acute GVHD:~Severity of Individual Organ Involvement:~Skin~1 a maculopapular eruption involving less than 25% of the body surface~2 a maculopapular eruption involving 25-50% of the body surface~3 generalized erythroderma~4 generalized erythroderma with bullous formation and/or with desquamation Liver~1 bilirubin 2.0-3.0mg/100mL~2 bilirubin 3-5.9mg/100mL~3 bilirubin 6-14.9mg/100mL~4 bilirubin >15mg/100mL Gut Diarrhea is graded +1 to +4 in severity. Nausea/vomiting and/or anorexia caused by GVHD is assigned as +1 in severity Diarrhea~1 <1000mL of liquid stool/day~2 >1,000mL of stool/day~3 >1,500mL of stool/day~4 2,000mL of stool/day, severe abdominal pain, with or without ileus~Severity of GVHD:~Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver"|Day 100, Month 6|This is cumulative incidence of grades 2-4 aGVHD at 100 days and at 6 months. Out of the total number of participants, grades 2-4 aGVHD occurred in 79 patients.|||percentage of analyzed participants|||Number
1282356|NCT00245037|Secondary|Relapse Mortality|The percentage of patients (out of 147 participants) who relapsed at Years 1 and 2. Relapse is defined as the presence of >5% blasts by morphology on a post-transplant bone marrow aspirate.|Years 1 and 2||||percentage of analyzed participants|||Number
1282557|NCT00243061|Secondary|Response Duration||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 years|None of the patients had Partial or complete response|||months|||Number
1282357|NCT00245037|Secondary|Progression-Free Survival|"The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5.~Definition of Disease Progression:~MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%.~CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells.~AML/ALL: Any incidence of relapse (>5% blasts) by evaluation of the bone marrow aspirate.~CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by >25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis.~MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (>5%) or worsening cytopenia or cytogenetic evidence of recurrence."|Years 1, 2, 3, and 5||||percentage of analyzed participants|||Number
1282358|NCT00245037|Secondary|Overall Survival|The percentage of overall patient survival (out of 147 participants) for Years 1, 2, 3 and 5.|Years 1, 2, 3 and 5||||percentage of analyzed participants|||Number
1282359|NCT00245037|Primary|Non-relapse Mortality|Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease.|Two years post-transplant||||Participants|||Count of Participants
1282360|NCT00245037|Primary|Regimen-Related Toxicities|Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.|5 years post-transplant||||Toxicities|||Number
1282361|NCT00245011|Secondary|Correlative Dose of Radiation by Low Dose and High Dose Samarium-153||completion of treatment|||||||
1282362|NCT00245011|Secondary|Long Term Side Effects of Infusional Samarium-153 After Study Treatment||Continual|||||||
1282363|NCT00245011|Secondary|Toxicity at End of Study Treatment||Continual and at End of Study|||||||
1282364|NCT00245011|Secondary|Overall and Progression-free Survival After Study Treatment||Continual|||||||
1282365|NCT00245011|Secondary|Predictive Value of Imaging Studies||At Time of Tumor Resection|||||||
1282366|NCT00245011|Primary|Tumor Response|WHO (World Health Organization) tumor measurement criteria used to determine response.|1 week after study treatment|11 subjects, heavily treated with chemotherapy with osteosarcoma metastatic to bone were enrolled; 10 evaluable for response. Mean age: 18 years. Age range was14-30 years.|||participants|||Number
1282367|NCT00244985|Secondary|Overall Survival (OS) Rate at 2 Years|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|2 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1282368|NCT00244985|Secondary|Progression Free Survival (PFS) Rate at 2 Years|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions.|2 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1282369|NCT00244985|Secondary|Overall Response Rate (Complete and Partial Responses) at 20 Weeks|Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes > 1.5 before therapy. Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the > or = to 50% decrease. Additionally, no appearance of new lesions is noted.|20 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1282370|NCT00244985|Secondary|Partial Response Rate at 20 Weeks|Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the > or = to 50% decrease. Additionally, no appearance of new lesions is noted.|20 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1282371|NCT00244985|Primary|Complete Response Rate at 20 Weeks|Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes > 1.5 em before therapy). Previously involved nodes that were 1.1 to 1.5 in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment or by more than 75% in the sum of the products of the greatest diameters (SPD). The patient must also be free from symptoms related to lymphoma, if present before therapy with no worsening in performance status from baseline. Bone marrow, if initially positive at baseline, must be histologically negative for lymphoma and the liver and spleen, if enlarged due to lymphoma at baseline, should be normalized.|20 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1282372|NCT00244933|Secondary|In Vivo Effects of Genistein in Breast Cancer Tissue Biomarkers (Ki67, TUNEL Assay, p-Akt, NF-kB, Immunohistochemistry and cDNA Microarray Analysis)||At baseline (pre-genistein treatment) and 7 days following genistein treatment|||||||
1282373|NCT00244933|Secondary|Correlate Responses With Plasma Genistein Levels||At course 1 day -7, course 1 day -1 (before and 4 hours after dose), course 2 day 1 (before and 4 hours after dose)|||||||
1282374|NCT00244933|Secondary|Qualitative and Quantitative Toxicities||30 days following treatment|||||||
1282375|NCT00244933|Secondary|Duration of Survival||At 1 year following study treatment|||||||
1282376|NCT00244933|Secondary|Time to Disease Progression||From the time that treatment is initiated until the time restaging indicates progressive disease.|||||||
1282377|NCT00244933|Secondary|Overall Survival||From the time the last patient comes off study treatment for one year to monitor survival|||||||
1282378|NCT00244933|Secondary|Duration of Response||From the time the last patient comes off study treatment for one year|||||||
1282379|NCT00244933|Primary|Objective Response Rate by RECIST Criteria Following|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 2 courses until disease progression or death, up to 24 weeks||||participants|||Number
1282380|NCT00244881|Secondary|Response/Stable Disease Rate Defined as the Percentage of Patients Demonstrating CR + PR + SD||12 weeks||||percentage of participants|||Number
1282381|NCT00244881|Primary|Objective Response Rate (ORR = CR + PR) Classified According to RECIST Criteria|RECIST 1.0 Criteria|Up to 7 years||||percentage of participants||95% Confidence Interval|Number
1282382|NCT00244881|Primary|Fraction of Patients With Increased Levels of Circulating Endothelial Cells|An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).|After 3 weeks of treatment||||percentage of participants|||Number
1282383|NCT00244855|Secondary|Survival|Percentage of patients remaining alive estimated according to the Kaplan-Meier method|At 6 months, 12 months and 24 months after enrollment||||Kaplan-Meier estimated % of patients||95% Confidence Interval|Number
1282384|NCT00244855|Primary|Progression-free Survival|Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method|At 3 and 6 months after enrollment||||Kaplan-Meier estimated % of patients||95% Confidence Interval|Number
1282385|NCT00244764|Secondary|Progression-free Survival|Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a >=20% increase in target lesions.|From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)|All Enrolled Population. Participants who did not progress or die were censored at their last radiologic assessment.|||weeks||95% Confidence Interval|Median
1282386|NCT00244764|Secondary|Duration of Response|Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.|First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.|All participants in the Enrolled Population who had a CR or PR|||weeks||95% Confidence Interval|Median
1282387|NCT00244764|Primary|Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants|The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.|Week 12|Subset of the All Enrolled Population including only the first 60 participants|||participants|||Number
1282388|NCT00244764|Primary|Overall Response by RECIST Criteria|The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a >=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.|Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.|All Enrolled: all participants who received at least one dose of pazopanib|||participants|||Number
1282389|NCT00244751|Secondary|GI262570 Serum Concentrations on Week 2, 16, 28, 40, and Week 52|Samples for Week 2 serial group were planned to be collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. For Weeks 16 and 40 samples were planned to be collected at 0 (pre-morning dose)1 and between 1.5-6 hour post-morning dose 2. For Weeks 28 and 52 samples were planned to be collected at 0 (pre-morning dose)1 and between 6-10 hour post-morning dose 2.|Weeks 2, 16, 28, 40 and 52|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing. Data was not collected for this endpoint.||||||
1282390|NCT00244751|Secondary|Volume of Distribution Expressed as a Function of Bioavailability (V/F) of GI262570|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||milliliter||Geometric Coefficient of Variation|Geometric Mean
1282391|NCT00244751|Secondary|Terminal Elimination Half-life (T1/2), Time to First Quantifiable Concentration (Tlag) and Time to Cmax (Tmax) of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||hour||Full Range|Median
1282392|NCT00244751|Secondary|DN Cmax of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose) 1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose) 1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||Nanograms per milliliter per mg||Geometric Coefficient of Variation|Geometric Mean
1282558|NCT00243061|Secondary|Survival Rate||At 1 year||||percentage of participants||95% Confidence Interval|Number
1282393|NCT00244751|Secondary|Maximum Observed Concentration (Cmax), Minimum Observed Concentration (Cmin) of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1282394|NCT00244751|Secondary|Apparent Clearance Following Oral Dosing (CL/F) of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||milliliter per hour||Geometric Coefficient of Variation|Geometric Mean
1282395|NCT00244751|Secondary|Dose Normalized (DN) AUC (0-tau) of GI262570 on Week 2|Sample s for Week 2 serial group were collected at 0 (pre-morning dose )1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose )1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||Hours nanograms per milliliter per mg||Geometric Coefficient of Variation|Geometric Mean
1282396|NCT00244751|Secondary|Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length 'Tau' (AUC [0-tau]) of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|The Pharmacokinetic (PK) Parameter Population included all participants in the subset having the serial PK profiles performed at Week 2 and having sufficient data for the calculation of the PK parameters. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||Hour nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1282397|NCT00244751|Secondary|Median Change From Baseline in Serum HCV RNA Levels Over Time|Serum for HCV RNA levels were collected at pre-screen, Baseline, Week 28, Week 52, and at the 4 week follow up visit. Value at Day 1 visit (day of first dose) was considered as Baseline. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and up to 4 weeks post-treatment (52 weeks)|MITT Population. Only those participants available at the specified time points were analyzed.|||Log10 International unit per milliliter||Full Range|Median
1282398|NCT00244751|Secondary|Mean Change From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 52|Value at Day 1 visit (day of first dose) was considered as Baseline. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and Week 52|MITT Population. Only those participants with data available at the indicated time point were analyzed.|||Log10 International unit per milliliter||Standard Deviation|Mean
1282399|NCT00244751|Secondary|Median Change From Baseline in Serum ALT Over Time|ALT was assessed as per upper limit of normal where the normal range was 0-48 international units per liter. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and up to 4 weeks post-treatment (52 weeks)|MITT Population. Only those participants available at the specified time points were analyzed.|||Per upper limit normal||Full Range|Median
1282400|NCT00244751|Secondary|Mean Change From Baseline in Measures of Insulin Resistance|Insulin resistance was measured using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), Belfiore Insulin Sensitivity Index (ISI) and Quantitative Insulin Sensitivity Check Index (QUICKI). HOMA-IR = fasting plasma insulin*fasting plasma glucose / 22.5 and ISI = 2 / [(fasting plasma glucose from the participant / fasting plasma glucose normal reference range)*( fasting plasma insulin from the participant / fasting plasma insulin normal reference range) + 1] and QUICKI = 1/(log[fasting plasma Insulin] + log[fasting plasma glucose]). Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and Week 52|As Treated Population. Only those participants with data available at the indicated time point were analyzed.|||Units on a scale||Standard Deviation|Mean
1282401|NCT00244751|Secondary|Mean Change From Baseline in Serum ALT Levels|ALT was assessed as per upper limit of normal where the normal range was 0-48 international units per liter. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and Week 52|MITT Population. Only those participants with data available at the indicated time points were analyzed.|||Per upper limit normal||Standard Deviation|Mean
1282559|NCT00243061|Secondary|Median Survival Time||Up to 6 years||||months||95% Confidence Interval|Median
1282560|NCT00243061|Primary|Prolonged Stable Disease According to RECIST||Up to 6 months||||participants|||Number
1282402|NCT00244751|Secondary|Mean Change From Baseline in Serum FibroSure (FibroTest/ActiTest) Score at Week 52|FibroTest was for the assessment of fibrosis. Fibro test was calculated using an original combination of five highly concentrated serum biochemical markers; alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin and gammaglutamyltransferase. FibroTest scores range from 0.00 to 1.00 where 0.0-0.21 is no fibrosis and >= 0.59 is cirrhosis. Acti-test was calculated using 6 serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and alanine aminotransferase. ActiTest was used for the assessment of necroinflammatory activity. Test score ranges from 0.00 to 1.00, where 0.00-0.17 indicates no necrosis and >= 0.61 indicates severe necrosis. Day 1 value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and Week 52|MITT Population. Only those participants with data available at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
1282403|NCT00244751|Secondary|Mean Change From Screening in Metavir Scores at Week 52|Metavir activity score ranged from 0 to 3 (higher score indicates severe symptoms of necrosis). 0: Piecemeal necrosis (PMN) absent and lobular necrosis (LN) absent or slight, 1: PMN slight and LN moderate, 2: PMN moderate and LN severe, 3: PMN severe. Metavir fibrosis score ranged from 0 to 4 (higher score indicates severe symptoms of necrosis). 0: No fibrosis, 1: Portal fibrosis without septa, 2: Portal fibrosis with septa, 3: Septal fibrosis without cirrhosis, 4: Cirrhosis. Change from screening was calculated as the post screening assessment minus the screening assessment for a given parameter.|Screening and Week 52|MITT Population. Only those participants available at the specified time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
1282404|NCT00244751|Secondary|Mean Change From Screening in Total Ishak Score (Necroinflammatory Score and Fibrosis Score) at Week 52|Ishak score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The necroinflammatory score is the combined score for necrosis and inflammation domains and ranged from 0 (best) to 14 (worst). Change from screening was calculated as the post screening assessment minus the screening assessment for a given parameter.|Screening and Week 52|MITT Population. Only those participants available at the specified time point were analyzed|||Scores on a scale||Standard Deviation|Mean
1282405|NCT00244751|Secondary|Number of Participants Whose Ishak Fibrosis Score Remains Unchanged at Week 52|No change was defined as having the same score at both Baseline and at Week 52. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.|Week 52|MITT Population.|||Participants|||Count of Participants
1282406|NCT00244751|Secondary|Number of Participants Regressing at Least 1 Point on the Ishak Fibrosis Score at Week 52|Regression was defined as a decrease by at least one point in the fibrosis score. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.|Week 52|MITT Population.|||Participants|||Count of Participants
1282407|NCT00244751|Secondary|Number of Participants Progressing at Least 1 Point on the Ishak Fibrosis Score at Week 52|Progression was defined as an increase by at least one point in the fibrosis score. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.|Week 52|MITT Population.|||Participants|||Count of Participants
1282408|NCT00244751|Primary|Number of Participants With Fluid Retention Events|Fluid retention event was one of the AEs reported. AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 4 weeks post-treatment (52 weeks)|As Treated Population.|||Participants|||Count of Participants
1282409|NCT00244751|Primary|Mean Change From Baseline in Heart Rate|Heart rate assessment were done at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to be missing.|Baseline and up to 4 weeks post-treatment (52 weeks)|As treated population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
1282410|NCT00244751|Primary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSP)|SBP and DBP readings were taken at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and up to 4 weeks post-treatment (52 weeks)|As Treated Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury||Standard Deviation|Mean
1282411|NCT00244751|Primary|Number of Participants With Change in Toxicities Grades 3 and 4 of Laboratory Parameters Over Time|Clinical laboratory parameters: Alkaline phosphatase, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Total bilirubin, Cholesterol, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Glucose, Hemoglobin, Potassium, Low density lipid (LDL) cholesterol, Lymphocytes, Sodium, Segmented neutrophils, Platelet count, White blood cell (WBC) count were assessed for change in grade toxicities. Toxicities were graded as grade 1 to grade 4 in increasing order of severity of toxicity. Thus grade 4 indicating severe toxicity. Only those parameters with grade 3 and 4 toxicities are presented.|Up to 4 weeks post-treatment (52 weeks)|As Treated Population. Only those participants available at the specified time points for particular parameter were analyzed.|||Participants|||Count of Participants
1282412|NCT00244751|Primary|Number of Participants With Abnormal ECG Findings|A standardized 12-lead ECGs were recorded at pre-screening, and pre-dose, at Baseline/Day 1, Weeks 16, 34, and 52 or withdrawal and at the 4 week follow-up visit. Any conditions such as bundle branch block, repolarization, depolarization, abnormal sinus rhythms, atrial fibrillation etc. are considered to be clinically abnormal findings.|Up to 4 weeks post-treatment (52 weeks)|As Treated Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1282413|NCT00244751|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to 4 weeks post treatment (52 weeks)|As Treated Population consisted of all participants for whom no clear evidence was available of failure to take study medication.|||Participants|||Count of Participants
1282414|NCT00244751|Primary|Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52|In ranked assessment (fibrosis and necroinflammation), available slides from each participant were evaluated as to whether one slide presents a globally more benign histopathology or whether the matched slides comprise globally equivalent histologic patterns. Subsequent data analysis revealed whether slides scored (within matched pairs of slides) as more benign occurred in different proportions of the Week 52 liver biopsies, according to treatment group. The number of participants with paired biopsies was based on the number with a Rank Assessment.|Week 52|MITT Population. Only those participants with paired biopsies at the indicated time point were analyzed.|||Participants|||Count of Participants
1282415|NCT00244751|Primary|Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis|A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. Morphometric analysis was performed using specimens stained with Sirius red and computerized image analysis. Sirius red was used to stain extracellular collagen in liver sections. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.|Baseline and at Week 52|MITT Population. Only those participants with data available at the indicated time point were analyzed.|||Ratio of positive area||Standard Deviation|Mean
1282416|NCT00244751|Primary|Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52|A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. The immunohistochemical marker assessed was smooth muscle alpha-actin (aSMA). Sections of the liver biopsies were stained by standard immunocytochemical techniques using a monoclonal antibody to smooth muscle actin with ‘very intense purple’ as the detection chromogen. This gives a reddish-purple color to the activated stellate cells, which strongly contrasts with the rest of the tissue. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.|Baseline and Week 52|Modified Intent to Treat (MITT) Population consisted of all participants with chronic hepatitis C randomized, regardless of whether or not the study drug was actually taken or if the participant completed the planned duration of the study. Only those participants with data available at the indicated time points were analyzed.|||Ratio of positive area||Standard Deviation|Mean
1282417|NCT00244725|Secondary|Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment|The ranges (low concern value; high concern value) for AST (none; > 3 fold upper normal limit (ULN) ), ALT (none; >3 fold ULN), total bilirubin (none; >= 34.2 micromole per litre [umol/L]), Direct bilirubin (none; >= 34.2 umol/L). Percentage of participants with elevated values by 2 fold and 3 fold from ULN any time on-treatment were reported.|Up to 12 days|ITT population. Number of participants were available at the time of analysis were included.|||Percentage of participants||95% Confidence Interval|Number
1282425|NCT00244725|Secondary|Percentage of Participants With PE Over 10 ± 2 Days of Treatment|Participant who reported symptoms of PE were considered to have had an adjudicated objectively confirmed symptomatic PE if the ICAC answer to the question ‘Was a PE identified?’ was ‘Yes’. E was characterized as fatal PE non-fatal PE and total PE events. Data has been presented for fatal PE non-fatal PE and total PE events over 12 days.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1282468|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Mobility|Range = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
1282418|NCT00244725|Secondary|Percentage of Participants With Total VTE Any Time After Start of Treatment|Participants were assessed for VTE at all study visits and at the end of the study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study were received a mandatory bilateral venogram. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the ICAC-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic DVT at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. Percentage of participants with total VTE any time after start of treatment were reported.|Up to Visit 9 (Day 28 post treatment)|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis|||Percenatge of participants||95% Confidence Interval|Number
1282419|NCT00244725|Secondary|Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment|A participant was included in the ICAC-adjudicated incidence of major bleeding if experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were efficacy evaluable or reported a major bleed or VTE by the time of early withdrawal were used for the analysis|||Percentage of participants||95% Confidence Interval|Number
1282420|NCT00244725|Secondary|Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment|A participant was included in the ICAC-adjudicated incidence of major bleeding if participant experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Major bleed was defined as clinically overt bleeding, 1) Clinical overt bleeding: clinically apparent bleeding or signs and/or symptoms suggestive of bleeding with confirmatory imaging studies (e.g., ultrasound, computed tomography) 2. Critical Site Involvement: Intracranial, retroperitoneal, intra-ocular, intraspinal, pericardial. 3. Decrease in Hgb > 2 g/dL from baseline, 4. Transfusion of > 2 units of packed RBCs, 5. Medical or Surgical Intervention for the Reported Bleed, 6. Fatal Bleed. If the event satisfied one of the above criteria.|Up to 12 days|ITT Population. The participants from ITT population who completed study treatment (Day-10 visit) or reported a major bleed by the time of early withdrawal were used for the analysis|||Percentage of participants||95% Confidence Interval|Number
1282421|NCT00244725|Secondary|Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up|In all participants, additional 3 milliliter of blood was collected at the time of other blood sampling as follow: Baseline, Day 3 (predose, 2, 4, 8, 10, and 12 hours post dose), Day 5 (predose), and Day 10 (predose) or early withdrawal from study medication for the assessment of anti-factor IIa activity. Samples were collected in 3.8% sodium citrate tubes and immediately chilled in ice. Plasma were centrifuged and frozen at approximately -20ºC until time of shipment to the regional central laboratory. Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up were reported.|Up to 68 days|ITT population.|||Microgram per millilitre (mcg/ml)||Standard Deviation|Geometric Mean
1282422|NCT00244725|Secondary|Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment|A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. The participant was considered to had a proximal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ was ‘DVT’. The participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ was ‘DVT’. Percentage of participants with total symptomatic (distal and proximal) VTE over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Perentage of participants||95% Confidence Interval|Number
1282423|NCT00244725|Secondary|Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment|A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. The participant was considered to had a proximal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’. The participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1282424|NCT00244725|Secondary|Number of Death Due to VTE Over 10 ± 2 Days of Treatment|A participant was considered dead from an adjudicated VTE-related cause if the death classification was recorded as ‘Fatal PE’. A participant was considered to have died from an investigator-assessed VTE-related cause if the investigator’s death classification was recorded as ‘Fatal PE’. Number of death due to VTE over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Participants|||Number
1282467|NCT00243919|Secondary|Fugl-Meyer Lower Extremity Score|Range 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
1282426|NCT00244725|Secondary|Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment|A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Percentage of paticipants||95% Confidence Interval|Number
1282427|NCT00244725|Secondary|Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment|Proximal DVT is defined as DVT in or above the popliteal vein. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a proximal DVT if either of the ICAC answers to the questions ‘Left proximal’ and ‘Right proximal’ was ‘DVT’. Percentage of participants with proximal DVT over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1282428|NCT00244725|Primary|Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment|Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.|Up to Visit 7 (10 ± 2 days of treatment)|ITT population comprised of all participants who were randomized and received at least one dose of study treatment. Total number of participants with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at study completion were used for analysis.|||Percentage of participants||95% Confidence Interval|Number
1282429|NCT00244712|Secondary|Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction|The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.|Baseline through 96 weeks|The Safety population which included all randomized participants who received at least one dose of study medication.|||participants|||Number
1282430|NCT00244712|Secondary|Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility|A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.|Baseline and time of virologic failure (up to Week 96)|Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria and had the M184 mutations.|||participants|||Number
1282431|NCT00244712|Secondary|Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks|A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Baseline and time of virologic failure (up to Week 96)|Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations|||participants|||Number
1282432|NCT00244712|Secondary|Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96|The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions.|Baseline to Week 96|The Intent-To-Treat-Exposed (ITT-E) population|||participants|||Number
1282433|NCT00244712|Secondary|Median Change From Baseline in CD4+ Cells at Weeks 48 and 96|A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.|||cells per cmm||Full Range|Median
1282434|NCT00244712|Secondary|Median Change From Baseline in HIV-1 RNA at Week 48 and 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.|||log10 copies/mL||Full Range|Median
1282435|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
1282436|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
1282437|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
1282438|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
1282439|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
1282440|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Week 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F.|||percentage of participants|||Number
1282441|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Week 48|The Intent-To-Treat-Exposed (ITT-E) population which included all patients that had received at least one dose of study medication. The secondary analysis methods were time to loss of virologic response (TLOVR), Observed (Obs), and missing/discontinuation=failure (M/D=F) analyses.|||percentage of participants|||Number
1282442|NCT00244712|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).|Week 48|The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA >=50 copies/mL.|||percentage of participants|||Number
1282443|NCT00244621|Secondary|Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28||From randomisation to day 28||||Percent change||Inter-Quartile Range|Median
1282444|NCT00244621|Secondary|Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28||From randomisation to day 28||||Percent change||Inter-Quartile Range|Median
1282445|NCT00244621|Secondary|Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)||From randomisation to end of double-blind treatment (4 weeks)||||mm Hg||Standard Deviation|Mean
1282446|NCT00244621|Primary|Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)||From randomisation to end of double-blind treatment (4 weeks)||||mm Hg||Standard Deviation|Mean
1282447|NCT00244374|Secondary|HIV Vaccine Trial Knowledge|"Participants were asked if they agreed or disagreed with or were unsure of each of eight statements about HIV vaccine trial concepts from the HIV Network for Prevention Trials (HIVNET).~Preventive HIV vaccine studies enroll people who are HIV-positive and HIV-negative.~Some participants in HIV vaccine studies will get a real vaccine, and some will get a placebo (an inactive substance).~Only vaccines known to be at least 50% effective at preventing HIV are tested in HIV vaccine studies.~Once a large scale HIV vaccine study begins, we can be sure the vaccine is completely safe.~Participants are told whether they got the HIV vaccine or the placebo at the end of HIV vaccine studies.~HIV vaccines will never affect a person's HIV test results.~An HIV vaccine can infect a person with HIV disease.~People in vaccine studies know whether or not they got the placebo because only the vaccines cause side effects."|Baseline|Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data|||Participants|||Number
1282526|NCT00243386|Secondary|Maximum Plasma Concentration (C-max)|Maximal Factor VIII Concentration After Infusion|Within 1 hour post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||IU/dL||Standard Deviation|Geometric Mean
1282448|NCT00244374|Secondary|HIV Vaccine Trial Willingness|"We assessed knowledge about vaccine trials and willingness to participate in preventive HIV vaccine trials by asking the question: How willing would you be to join a study of a vaccine to prevent HIV infection, if the study were to start tomorrow?. Willingness was measured on a 4-point response scale, ranging from 1 (Definitely not willing) to 4 (Definitely willing)."|Baseline|Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data|||Participants|||Number
1282449|NCT00244374|Secondary|Viral Transmission Risk Behavior Association With Travel|In a cross-sectional analysis of 355 subjects enrolled between 2004 and 2006, we estimate the associations between travel in the 3 months prior to baseline and behaviors occurring in the 30 days prior to baseline, such as drug and alcohol and sexual behaviors, that may facilitate the spread of viral infections.|Baseline|Cross-sectional analysis of 355 subjects enrolled between 2004 and 2006|||percentage of participants|||Number
1282450|NCT00244374|Secondary|Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses|To examine the effect of hepatitis C virus (HCV) infection on vaccine effectiveness, we compared anti-HBs (antibody to the hepatitis B surface antigen) seroconversion after three vaccine doses between anti-HCV (antibody to the hepatitis C virus) positive and anti-HCV negative participants.|12 months|139 participants who completed 3 vaccine doses were included in the analysis. Enrollment for this aim continued after enrollment into the 12-month vaccine adherence trial closed; an additional 51 persons were found eligible and enrolled.|||Participants|||Number
1282451|NCT00244374|Primary|Vaccine Series Completion|The primary outcome was the completion of the four-dose vaccine series in a 12 month period.|12 months||||participants|||Number
1282452|NCT00244140|Secondary|The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images|The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.|||Number of diagnostic CECTs|||Number
1282453|NCT00244140|Secondary|The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.|A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.|||Number of participants in QOI grade|||Number
1282454|NCT00244140|Secondary|The Ability of the Investigator to Make a Diagnosis Based on the CECT Images|The number of participants with diagnostic CECTs as assessed by the investigators.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.|||Number of diagnostic CECTs|||Number
1282455|NCT00244140|Primary|The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.|A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.|||Number of participants in QOI grade|||Number
1282456|NCT00244101|Secondary|Parental Questionnaire for Health Status||at 24 months of age|||||||
1282457|NCT00244101|Secondary|Days in Hospital||prior to hospital discharge|||||||
1282458|NCT00244101|Secondary|Days of Ventilator Support||prior to hospital discharge|||||||
1282459|NCT00244101|Secondary|Complications of Prematurity||prior to hospital discharge|||||||
1282460|NCT00244101|Primary|Death||36 weeks adjusted age|||||||
1282461|NCT00244101|Primary|Death or Chronic Lung Disease||at 36 weeks postmenstrual age|intention to treat analysis|||participants|||Number
1282462|NCT00244010|Primary|Treatment Failures|The primary objective of this study is to evaluate the safety of HAPLO HSCT for patients with refractory severe aplastic anemia (SAA) or refractory cytopenias. The treatment plan would be considered unsafe if we can demonstrate that it is associated with a significantly higher treatment failure rate. The treatment failure is defined as any occurrence of the following events, overall grade III-IV acute GVHD, graft failure or death due to any cause within 100 days post HSCT or after the last cellular product infusion, if required.|100 days post transplant|Enrollment was terminated due to the PI leaving the institution. Insufficient data was generated to answer the objective.||||||
1282463|NCT00243932|Primary|Change in the ALS Functional Rating Scale-revised (ALSFRSr) Score.|The ALSFRSr, a questionnaire-based scale assessing daily living function ranging from 48 (best score) to 0 (worst), was administered to the patient, or to a proxy if the patient could not communicate effectively. Decline was defined as ALSFRSr at baseline minus ALSFRSr at month 9. Thus a positive value indicates worsening.|9 months||||units on a scale||Standard Deviation|Mean
1282464|NCT00243932|Secondary|The Change Over 9 Months in Forced Vital Capacity; Fatigue Severity Scale; Short Form-36; and 8OH2dG (a Biomarker of Oxidative Stress Measured in a Blood Sample).||9 months|||||||
1282465|NCT00243919|Secondary|Activities Specific Balance Confidence (ABC) Score|Range = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
1282466|NCT00243919|Secondary|Berg Balance Score|Range = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
1282469|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)|Range 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
1282470|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Participation|Range = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL–IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
1282471|NCT00243919|Secondary|Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day|As measured with a step activity monitor averaged over 2 days.|Baseline, 6 months and 12 months post-stroke||||steps||Inter-Quartile Range|Median
1282472|NCT00243919|Secondary|6 Minute Walking Distance (Meters)|Distance walked in 6 minutes.|Baseline, 6 months and 12 months post-stroke||||meters||Standard Deviation|Mean
1282473|NCT00243919|Secondary|6 Month Outcome: Walking Speed: Measured During a 10-meter Walk||Baseline and 6 months post-stroke||||m/sec||Standard Deviation|Mean
1282474|NCT00243919|Secondary|Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke|Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.|Baseline and 6 months post-stroke|Intention to treat analysis. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||percent of participants|||Number
1282475|NCT00243919|Primary|Walking Speed: Measured During a 10-meter Walk||Baseline and 12 months post-stroke||||m/sec||Standard Deviation|Mean
1282476|NCT00243919|Primary|Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke|Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.|12 months post-stroke|Intention to treat analysis. Missing data were imputed using the LOCF method.|||percent of participants|||Number
1282477|NCT00243841|Secondary|Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events|Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment.|up to 4 years|All patients who received treatment|||Participants|||Count of Participants
1282478|NCT00243841|Secondary|Overall Survival|Kaplan-Meier Analysis will be used to calculate the median and 95% CI for overall survival. This will be calculated from the time of treatment until death. If a patient did not die, the patient will be censored at their last known alive date.|Up to 8 years|all patients who received treatment and had a post-baseline assessment|||months||95% Confidence Interval|Median
1282479|NCT00243841|Secondary|Time to In-field Failure|Kaplan-Meier Analyses will be used to calculate the median and 95% Confidence Interval for the time until in-field failure. This will be calculated from the time of treatment until the time of in-field failure. If a patient did not have in-field failure, the patient will be censored at their last evaluation date.|up to 4 yrs|All pts who received treatment and had a post-baseline assessment|||months||95% Confidence Interval|Median
1282480|NCT00243841|Primary|6 Month Local In-field Control|Percent of patients and the 95% Binomial Confidence interval who were free of in-field progression at 6 months following treatment for the patients in Phase II|6 months|All patients who received treatment and had a post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1282481|NCT00243841|Primary|Number of Patients With DLTs|Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.|6 weeks|All patients who received treatment in Phase I|||Participants|||Count of Participants
1282482|NCT00243659|Secondary|Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge|Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.|6 weeks|The analysis population is the efficacy evaluable at visit five.|||patients|||Number
1282483|NCT00243659|Primary|Number of Patients Who Achieved Hemostatic Efficacy After Surgery|Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.|6 weeks|The analysis population is the efficacy evaluable at visit three.|||patients|||Number
1282484|NCT00243503|Secondary|Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.|||ng/mL||Standard Deviation|Mean
1282485|NCT00243503|Secondary|Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.|||ng/mL||Standard Deviation|Mean
1282486|NCT00243503|Secondary|Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The Pharmacokinetic (PK) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
1282487|NCT00243503|Secondary|EORTC QLQ (BR23)|BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||scores on a scale||Standard Deviation|Mean
1282488|NCT00243503|Secondary|EORTC QLQ-C30|EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||scores on a scale||Standard Deviation|Mean
1282489|NCT00243503|Secondary|Probability of Survival at One Year|One- year survival probability was estimated using the Kaplan-Meier method.|From start of study treatment until death or 2 years from first study treatment|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||percentage of 1-year survival||95% Confidence Interval|Number
1282490|NCT00243503|Secondary|Overall Survival (OS)|Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.|From start of study treatment until death or 2 years from first study treatment|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||months||95% Confidence Interval|Median
1282491|NCT00243503|Secondary|Time to Progression (TTP)|Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||weeks||95% Confidence Interval|Median
1282492|NCT00243503|Secondary|Progression Free Survival (PFS)|Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||Weeks||95% Confidence Interval|Median
1282493|NCT00243503|Secondary|Percentage of Participants With Clinical Benefit|Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||Percentage of Participants||95% Confidence Interval|Number
1282494|NCT00243503|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.|From start of treatment through 18 months|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response.|||weeks||95% Confidence Interval|Median
1282495|NCT00243503|Primary|Percentage of Participants With Overall Confirmed Objective Disease Response|Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.|From start of treatment through 18 months|The intent-to-treat (ITT) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||percentage of participants||95% Confidence Interval|Number
1282496|NCT00243412|Secondary|Change From Baseline in Cyclic Citrullinated Peptide (CCP) Antibodies/Cytokines|Because of the different laboratory methods that were used to measure anti-CCP antibody levels, no summary statistics were calculated.|Baseline, 24 Months||||units|||Number
1282497|NCT00243412|Secondary|Change From Baseline in Rheumatoid Factor (RF)|Serum levels of rheumatoid factor at baseline, month 24 and change from baseline to month 24.|Baseline, 24 Months|Participants from the Safety-Evaluable population for whom data was available at baseline and month 24.|||IU/mL||Standard Deviation|Mean
1282498|NCT00243412|Secondary|DAS28-4 Erythrocyte Sedimentation Rate(ESR)|The DAS28-4(ESR) score is a measure of the subject’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient’s global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease In this trial, CRP rather than ESR was used, unless the CRP value was missing at both Day 1 and screening, in which case ESR value was used.|24 Months|Participants from the Intent−to−Treat (ITT) for whom data was available at baseline and month 24.|||Scores on a scale||Standard Deviation|Mean
1288787|NCT00140205|Secondary|Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)|Data were collected neither in Fed nor in Fasting state for the different doses of leptin|1 DAY or DAY 3|||||||
1282499|NCT00243412|Secondary|Change From Baseline in Functional Assessment for Chronic Illness Therapy–Fatigue (FACIT-F)|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient’s response to the questions (with the exception of 2 negatively stated), the greater the patient’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient’s health status.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.|||Scores on a scale||Standard Deviation|Mean
1282500|NCT00243412|Secondary|Change From Baseline in Health Assessment Questionnaire–Disability Index (HAQ-DI)|The Stanford HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in a certified translation of the local languages at the participating sites and was scored based on the instructions from the Stanford University Medical Center.The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.|||Scores on a scale||Standard Deviation|Mean
1282501|NCT00243412|Secondary|Change From Baseline in Short Form 36 (SF 36) Summary and Subscale Scores|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning (PF), Role Physical (RP), Bodily Pain(BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE),Mental Health (MH). Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) for whom data was available at baseline and month 24.|||Units on a Scale||Standard Deviation|Mean
1282502|NCT00243412|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response and Remission Using Disease Activity Score 28–4 (DAS28-4)C-reactive Protein (CRP)|"EULAR remission = DAS28-4(CRP) < 2.6 (Fransen et al. 2004.~EULAR response categories (van Gestel et al. 1999):~Good response = final DAS28-4(CRP) < 3.2 and decreased > 1.2 points from baseline Moderate response = final DAS28-4(CRP) ≥ 3.2 but ≤ 5.1 and decreased > 0.6 points from baseline or final DAS28-4(CRP) > 5.1 and decreased > 1.2 from baseline."|Baseline, 24 months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.|||Participants|||Number
1282503|NCT00243412|Secondary|Number of Participants With American College of Rheumatology (ACR) Major Clinical Response and/or Remission|"Major clinical response is an ACR70 response defined as improvement from baseline: ≥70% in tender joint count; ≥70% in swollen joint count; ≥70% in 3 of the following: Patient Pain Assessment, Patient Global Assessment, Physician Global Assessment, Patient Self-Assessed Disability, ESR or CRP for ≥169 consecutive days.~Remission: ≥5 requirements fulfilled for ≥2 consecutive months: Duration of morning stiffness <15 minutes, No fatigue, No joint pain, No joint tenderness or pain on motion, No soft tissue swelling in joints or tendon sheaths, ESR <30 mm/hour for women and <20 mm/hour for men."|24 months|Intent−to−Treat (ITT)|||Participants|||Number
1282504|NCT00243412|Secondary|Number of Participants With American College of Rheumatology Responses (ACR20, ACR50, and ACR70)|"ACR20 response was defined as satisfying the following 3 criteria improvement from baseline: ≥ 20% in tender joint count; ≥ 20% in swollen joint count; ≥ 20% improvement from baseline in 3 of the following 5 criteria:~Subject’s Global Assessment of Pain Subject’s Global Assessment of Disease Activity Physician’s Global Assessment Subject’s Self-Assessment Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) Note: The definitions of ACR50 and ACR70 are the same as ACR20, except that the 20% value in the above definition is replaced by 50% and 70% values, respectively."|Baseline, 24 months|Intent−to−Treat (ITT)|||Participants|||Number
1282505|NCT00243412|Secondary|Change From Baseline in Disease Activity Score 28-4 C-reactive Protein (DAS28-4(CRP))|The DAS28-4(CRP) score is a measure of the subject’s disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient’s global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at 24 months was analyzed for DAS28-4 (CRP).|Baseline, 24 months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.|||Scores on a scale||Standard Deviation|Mean
1282506|NCT00243412|Primary|Number of Participants With Either an Infection or a Grade III or IV Adverse Event (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE], Version 3.0)|"A Grade III Adverse Event (AE) is severe; defined as considerable interference with the subject’s daily activities, medical intervention/therapy required and hospitalization possible.~A Grade IV AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, hospitalization probable.~Because of the small sample size and the small number of subjects who completed Week 104, the analysis were limited to descriptive statistics only."|24 months|Safety−Evaluable Population|||Participants|||Number
1282507|NCT00243386|Post-Hoc|Median (IQR) Annualized Bleed Rates|Bleed rates (number of bleeding episodes per subject) were annualized to account for the varying number of days a subject may have actually been on each regimen.|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Per-Protocol Efficacy Analysis Set|||Bleeding episodes||Inter-Quartile Range|Median
1282508|NCT00243386|Secondary|Physical Component Scores (PCS) HRQoL Scores Change From On-Demand Period Through Prophylaxis Period|"Change = (End of on-demand treatment) – (End of prophylaxis regimen) A negative value for the median difference equates to a larger domain score for the prophylaxis regimen.~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic analysis set for participants ≥14 years of age|||Scores on a scale||Full Range|Median
1288788|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg|24-hour fed Leptin dose 0.1 mg/kg|1 DAY||||NG*H/ML||Standard Deviation|Mean
1282509|NCT00243386|Secondary|Bodily Pain HRQoL Scores Change From On-Demand Period Through Prophylaxis Period|"Change = (End of on-demand treatment) – (End of prophylaxis regimen). A negative value for the median difference equates to a larger domain score for the prophylaxis regimen.~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic analysis set for participants ≥14 years of age|||Scores on a scale||Full Range|Median
1282510|NCT00243386|Primary|Median Annualized Bleed Rate Estimates From Each of the 1 Year Prophylaxis Regimens|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Part 2 of the study):~Standard prophylaxis- infusions every 48 ±6 hours, dosed at 20 to 40 IU/kg.~PK-driven prophylaxis- infusions every 72 ±6 hours dosed at 20 to 80 IU/kg."|12 months ±2 weeks|Intent to treat|||Bleeds per year||Full Range|Median
1282511|NCT00243386|Secondary|HRQoL Scores Change From On-Demand Treatment Regimen Period Through Prophylaxis Period|"Differences in health domain scores = (End of on-demand treatment) – (End of prophylaxis regimen). A negative value for the median difference equates to a larger domain score for the prophylaxis regimen~Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS).~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic Analysis Set ≥14 Years and Older|||Scores on a scale||Full Range|Median
1282512|NCT00243386|Secondary|Health-related Quality of Life (HRQoL) Scores: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS at the End of Treatment Regimens|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Baseline SF-36v1 Scores, where data available. Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic Analysis Set|||Scores on a scale||Full Range|Median
1282513|NCT00243386|Secondary|Baseline Health-related Quality of Life (HRQoL) Scores: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Baseline SF-36v1 Scores, where data available. Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline|Safety Analysis Set|||Scores on a scale||Full Range|Median
1282514|NCT00243386|Secondary|Number of Participants With Severe SAEs and Severe Non-SAEs by Preferred MedDRA Term and Treatment Regimen|This outcome is focused only on SEVERE SAEs and SEVERE non-SAEs|Throughout the study period (4 years and 5 months)|Safety Analysis Set|||participants|||Number
1282515|NCT00243386|Secondary|AEs With Onset ≤1 Hour Following the End of an Infusion, Regardless of Relatedness||Throughout study period (4 years and 5 months)|Safety Analysis Set|||Events|||Number
1282516|NCT00243386|Secondary|Number of Participants With SAEs by Preferred MedDRA Term and Treatment Regimen||Throughout the study period (4 years and 5 months)|Safety Analysis Set|||participants|||Number
1282517|NCT00243386|Secondary|Number of Participants Who Reported ≥1 AE Regardless of Relatedness to IP by Treatment Regimen||Throughout the study period (4 years and 5 months)|Safety Analysis Set|||participants|||Number
1282518|NCT00243386|Secondary|Number of Participants Who Reported ≥1 AE Regardless of Relatedness to Investigational Product (IP)|Number of treated participants with 1 or more AE regardless of relatedness to IP|Throughout study period (4 years and 5 months)|Safety Analysis Set|||Participants|||Number
1282519|NCT00243386|Secondary|Number of Participants With AEs Related to Investigational Product (IP)|Number of treated participants with AEs judged to be possibly or probably related to treatment with IP|Throughout study period (4 years and 5 months)|Safety Analysis Set|||Participants|||Number
1282520|NCT00243386|Secondary|Factor VIII Inhibitor Development|Number of treated participants who developed factor VIII inhibitors|Throughout study period (4 years and 5 months)|Safety Analysis Set|||Participants|||Number
1282521|NCT00243386|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted clearance * mean residence time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||dL/kg||Standard Deviation|Mean
1282522|NCT00243386|Secondary|Mean Residence Time|Computed as total Area Under the Moment Curve (AUMC) divided by the total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
1282523|NCT00243386|Secondary|Weight-Adjusted Clearance|Computed as the weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||mL/(kg*h)||Standard Deviation|Mean
1282524|NCT00243386|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
1282525|NCT00243386|Secondary|Adjusted Incremental Recovery (IR)|"Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.~Adjusted IR defined as:~[Cmax (IU/dL) – pre-infusion FVIII (IU/dL)]/dose (IU/kg)"|30 minutes pre-infusion to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||IU/dL per IU/kg||Standard Deviation|Geometric Mean
1282529|NCT00243386|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~8 hrs after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Hemostatic Efficacy Rating Analysis Set (Participants with bleeding episodes that were rated)|||bleeding episodes|||Number
1282530|NCT00243386|Secondary|Bleeding Episodes Treated With 1 to ≥4 Infusions|The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis|Throughout the study period (4 years and 5 months)|Intent to Treat Efficacy Set|||Bleeding episodes|||Number
1282531|NCT00243386|Secondary|Total Weight-Adjusted Dose of rAHF-PFM Used Per Year for Each Prophylaxis Arm|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Part 2 of the study):~Standard prophylaxis- infusions every 48 ±6 hours, dosed at 20 to 40 IU/kg.~PK-driven prophylaxis- infusions every 72 ±6 hours dosed at 20 to 80 IU/kg."|12 months ±2 weeks|Intent to treat|||IU/kg||Inter-Quartile Range|Median
1282532|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and Any Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (Any Prophylaxis Treatment TABR).~Any Prophylaxis = Standard or PK-Driven Prophylaxis~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Intent to treat|||(bleeds/year)^(1/2)||Standard Deviation|Mean
1282533|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and PK-Driven Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (PK-Driven Prophylaxis Treatment TABR)~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); followed by Prophylaxis 12 months (± 2 weeks)|Intent to treat|||(bleeds/year)^(1/2)||Standard Deviation|Mean
1282534|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and Standard Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (Standard Prophylaxis Treatment TABR).~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); followed by Prophylaxis 12 months (± 2 weeks)|Intent to treat|||(bleeds/year)^(1/2)||Standard Deviation|Mean
1282535|NCT00243386|Primary|Mean Transformed Annualized Bleed Rate Estimates From Each of the 1-year Prophylaxis Regimens|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Study Part 2):~Standard prophylaxis (20-40 IU/kg (every 48 ±6 hour), exact regimen determined by investigator)~PK-driven prophylaxis (20-80 IU/kg (every 72 ±6 hour), exact regimen determined by sponsor)~Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X = bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the t-test."|12 months ±2 weeks|Per Protocol|||(bleeds/year)^(1/2)||Standard Deviation|Mean
1282536|NCT00243347|Secondary|Change From Baseline in Mean Arterial Blood Pressure (MAP)|Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 – MAP value at baseline).|Randomisation until Day 22|Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.|||mmHg||95% Confidence Interval|Mean
1282537|NCT00243347|Primary|Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)|Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value – baseline SUVmax value)/baseline SUVmax value)*100|Randomisation until Day 22|Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis. To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit.|||Percentage change in SUVmax||95% Confidence Interval|Geometric Mean
1282538|NCT00243269|Secondary|Health Related Quality of Life|Health-Related Quality of Life was assessed using the Functional Assessment of Cancer Therapy Scale – General (FACT–G). The FACT–G is a 28-item scale developed specifically for use in cancer clinical trials. Possible scores range from a low of 0 to a high of 112. Along with a total score representing HRQL, there are psychometrically validated subscales of physical, functional, social, and cognitive-emotional status. It has become one of the most commonly used measures in oncology, and we have used this scale in our previous studies.|5 days||||Units on scale||Standard Deviation|Mean
1282595|NCT00242567|Secondary|Time to Occurrence of Skeletal Related Event or Death|Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.|36 Months|The ITT Population consisted of all patients randomized to treatment.|||Days||95% Confidence Interval|Median
1282539|NCT00243269|Primary|Five-day Nausea Diary|"Nausea was measured using a five-day patient report diary. Each day was divided into 4 sections: morning, afternoon, evening, and night. Patients reported severity of nausea for each period daily. Severity of nausea was assessed on a 7-point rating scale, anchored at one end by 1 = “Not at all nauseated and at the other end by 7 = Extremely nauseated. The description “Moderately nauseated” was centered on the scale below the 4. Average Nausea was the mean severity for the 20 reporting periods."|Five days|All patients who did not have protocol violations who provided evaluable data were included in the analyses. No data imputation was used.|||Units on scale||Standard Deviation|Mean
1282540|NCT00243243|Primary|Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively||24 hours||||units of blood components|||Number
1282541|NCT00243191|Primary|To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies.|To obtain matched tumor tissue samples of trial participants dermatofibrosarcoma protuberans (DFSP)for the purpose of determining whether imatinib mesylate affects autocrine/paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in DFSP by comparing the level of phosphorylated platelet-derived growth factor receptor beta (PDGFRB) in DFSP after up to 2 weeks of treatment with imatinib to the level of phosphorylated PDGFRB pre-treatment.|Prior to and after 2-weeks of imatinib therapy|Population of paired tissue samples collected from patients with confirmed diagnosis of dermatofibrosarcoma protuberans. Tissue sample will be considered evaluable if there is adequate pre-treatment and on-treatment tumor tissue available for the proposed molecular studies, and resection of DFSP was completed after receiving imatinib.|||paired tumor tissue samples|||Number
1282542|NCT00243152|Secondary|Subjective Ratings of Pain During Magnetic Resonance Scanning|"Quantitative Sensory Testing (QST)~Stimuli Type: Heat, Cold, Brush Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness~Ratings on a likert scale of 0-10 with 0 being defined as no pain and 10 being defined as worst possible pain"|week 10 (during the scan)||||scores on a pain scale||Standard Deviation|Mean
1282543|NCT00243152|Primary|Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States|fMRI scans acquired Stimuli Type: Brush Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness fMRI scans acquired Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning** fMRI scans acquired Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning** Cortical, subcortical, and brain stem sensory regions Z-scores Increase or decrease in activation as affected by the drug|Week 10 during scanning session|The data's primary comparisons no longer exists per intervention.|||Z-statistic|||Number
1282544|NCT00243074|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of protocol treatment with AZD2171 (cediranib maleate)|||Participants|||Number
1282545|NCT00243074|Secondary|Adverse Event Rates|Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment. See adverse event tables for specific details.|Daily during protocol treatment|All patients who received protocol treatment were assessed for adverse events. See adverse event tables for specific details.|||Participants|||Count of Participants
1282546|NCT00243074|Secondary|Objective Response Rate Per Modified RECIST for Pleural Tumors|The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.|Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of AZD2171|||percentage of participants||95% Confidence Interval|Number
1282547|NCT00243074|Secondary|Disease Control Rate|The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.|Every 8 weeks until disease progression progression, up to 5 years.|Eligible patients who received AZD2171|||percentage of participants||95% Confidence Interval|Number
1282548|NCT00243074|Secondary|Progression-free Survival|From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 8 weeks until disease progression or death, up to 5 years.|Eligible patients who received AZD2171|||months||95% Confidence Interval|Median
1282549|NCT00243074|Secondary|Overall Survival|From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.|Eligible patients who received AZD2171|||months||95% Confidence Interval|Median
1282550|NCT00243074|Primary|Overall Response Rate|"confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.."|Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of AZD2171|||percentage of participants||95% Confidence Interval|Number
1282551|NCT00243061|Secondary|Change in Vessel Permeability and Blood Flow by DCE-MRI||From baseline to up to 28 days after starting daily oral dosing|data were not collected||||||
1282552|NCT00243061|Secondary|Changes in Levels of Soluble Angiogenic Factors||From baseline to up to 6 years|data were not collected||||||
1282553|NCT00243061|Secondary|Clinical Benefit Response||Up to 6 years|data were not collected||||||
1282561|NCT00243061|Primary|Objective Tumor Response (Partial or Complete Response) According to RECIST|"Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [J Nat Cancer Inst 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions, assessed by CT or MRI; Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 6 years|Out of 24 patients analyzed, 0 patients had objective response of PR or CR as defined by RECIST|||participants|||Number
1282562|NCT00243022|Secondary|Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record|The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.|At 2, 4, 6, 12, and 24 months|||||||
1282563|NCT00243022|Secondary|Overall Survival: Percentage of Patients That Were Alive at 1 Year|Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates.|1 year.|All 12 patients followed to death or censored at last visit when known alive|||percentage of particpants||95% Confidence Interval|Number
1282564|NCT00243022|Secondary|Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year|Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.|1 year|All 12 patients followed to progression or death, or censored at last visit when known alive|||percentage of participants||95% Confidence Interval|Number
1282565|NCT00243022|Secondary|Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months|Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.|6 months|All 12 patients followed to progression or death, or censored at last visit when known alive|||percentage of participants||95% Confidence Interval|Number
1282566|NCT00243022|Secondary|Quality of Life at 6 Months|Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30)|At 2, 4, 6, 12, and 24 months|At baseline and the most recent post treatment point in time, the QOL data for group 1 consist of n=3 patients and for group 2, n=2. Because of low patient numbers, no analysis was done.||||||
1282567|NCT00243022|Primary|Change From Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up – baseline edema.|at 6 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.|||cm^3||Standard Deviation|Mean
1282568|NCT00243022|Primary|Change From Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up – baseline edema.|at 4 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.|||cm^3||Standard Deviation|Mean
1282569|NCT00243022|Primary|Change From Pooled Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up – baseline edema|at 2 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.|||cm^3||Standard Deviation|Mean
1282570|NCT00242710|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24|BMD measurements of the total hip were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 24|MITT population for BMD of total hip: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.|||percent change||Standard Error|Least Squares Mean
1282571|NCT00242710|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24|BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 24|MITT population for BMD of lumber spine: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.|||percent change||Standard Error|Least Squares Mean
1282572|NCT00242710|Secondary|Percentage of Participants With Hyperplasia at Month 24|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Month 24|EE analysis population for Year 2 included all randomized participants who took at least 1 dose of test article, participated in study extension, had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had biopsy during Month 24, or had hyperplasia diagnosed before Month 24 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1282573|NCT00242710|Secondary|Percentage of Participants With Uterine Bleeding or Spotting|Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.|Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52|MITT population for uterine bleeding or spotting included all randomized participants who had received at least 1 dose of test article and had at least 1 day of on-therapy bleeding data. Imputation=LOCF. n=participants evaluable for this measure at specified time periods for each arm, respectively.|||percentage of participants|||Number
1282574|NCT00242710|Secondary|Percentage of Days With Breast Pain|Percentage of days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.|Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52|MITT population for breast pain: all randomized participants who took at least 1 dose of test article, and had data available at least for 5 of 7 days at screening and 20 days for at least 1 post-baseline interval. n=participants evaluable at specified time periods for each arm, respectively.|||percentage of days||Standard Error|Mean
1282575|NCT00242710|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12|BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 12|MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.|||percent change||Standard Error|Least Squares Mean
1282576|NCT00242710|Primary|Bone Mineral Density (BMD) of Total Hip at Screening|BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Screening|MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.|||g/cm^2||Standard Deviation|Mean
1282577|NCT00242710|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12|BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 12|MITT population for BMD of lumber spine: all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after test article administration was stopped were excluded) at Year 1. Missing values imputed using last observation carried forward (LOCF).|||percent change||Standard Error|Least Squares Mean
1282578|NCT00242710|Primary|Bone Mineral Density (BMD) of Lumbar Spine at Screening|BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Screening|Modified intent-to-treat (MITT) population for BMD of lumber spine included all randomized participants took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1.|||grams per square centimeter (g/cm^2)||Standard Deviation|Mean
1282579|NCT00242710|Primary|Percentage of Participants With Hyperplasia at Month 12|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Month 12|Efficacy evaluable (EE) analysis population for Year 1: all participants who were randomized and took at least 1 dose of test article, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1282580|NCT00242710|Primary|Percentage of Participants With Hyperplasia at Screening|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Screening|Endometrial hyperplasia at screening was an exclusion criterion and participants who had hyperplasia were not included in the analysis. Therefore this data is not available.||||||
1282581|NCT00242684|Post-Hoc|Percentage of Subjects With Average Daily Nutrient Intake <90% of Predicted Needs||While hospitalized on TCU, for up to 40 days||||percentage of subjects|||Number
1282582|NCT00242684|Primary|Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs||While hospitalized on TCU, for up to 40 days||||percentage of subjects|||Number
1282583|NCT00242658|Secondary|Change in Behavioral Processes of Change Between Baseline and 6 Months|"Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never."|Baseline and 6 months||||Scores on a Scale||95% Confidence Interval|Mean
1282584|NCT00242658|Primary|7-Day Physical Activity Recall (7-Day PAR)|Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.|6 months||||minutes||95% Confidence Interval|Mean
1282585|NCT00242632|Secondary|Change in Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching Between Time 1 and Time 2|The Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. The mean difference in the total number of correct words generated between time 1 and time 2 is calculated below.|6 months|All participants were grouped together for this Outcome Measure. As per the protocol, the analyses of neuropsychological variables were to be done separately for the ApoE-ɛ4 carriers and non-carriers, only if the ApoE-ε4 status was a significant predictor of change in neuropsychological performance.|||correct words||Standard Deviation|Mean
1282586|NCT00242632|Primary|Change in California Verbal Learning Test - Second Edition Proactive Interference Test Between Time 1 and Time 2|This tests verbal memory (word list). A list of words is presented and subjects are asked to recall as many as they can. Then a list of interference words is presented. Finally a recognition list of 44 words is presented where subjects are asked to distinguish between target words and distractors. The mean difference in the percentage of target words recalled between time 1 and time 2 is calculated below.|6 months|All participants were grouped together for this Outcome Measure. As per the protocol, the analyses of neuropsychological variables were to be done separately for the ApoE-ɛ4 carriers and non-carriers, only if the ApoE-ε4 status was a significant predictor of change in neuropsychological performance.|||percentage of target words recalled||Standard Deviation|Mean
1282587|NCT00242619|Primary|Clinical Global Impression-Severity Scale (CGI-S)|The Clinical Global Impression-Severity Scale (CGI-S) assesses depression severity. It is a 7-point scale, where 1 is the lowest level of depression severity and 7 is the highest level of depression severity.|12 weeks||||units on a scale||Standard Deviation|Mean
1282588|NCT00242619|Primary|Hamilton Depression Rating Scale (HDRS-21)|The Hamilton Depression Rating Scale (HDRS-21) measures depression severity on a scale from 0 to 21, with 0 being the lowest level of depression severity and 21 being the highest level of depression severity.|12 weeks||||units on a scale||Standard Deviation|Mean
1282589|NCT00242580|Secondary|Mean Change From Baseline in Total Area of Lesion at 12 Months|Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||mm^2||Standard Deviation|Mean
1282590|NCT00242580|Secondary|Number of Participants Requiring Verteporfin Treatment Throughout the Study|Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.|Baseline to Month 12|Observed data.|||Participants|||Number
1282591|NCT00242580|Secondary|Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Efficacy variable analyses were performed on the intent-to-treat (ITT) data set. The ITT set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||Percentage of Participants|||Number
1282592|NCT00242580|Secondary|Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||Percentage of Participants|||Number
1282593|NCT00242580|Secondary|Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||Percentage of Participants|||Number
1282594|NCT00242580|Primary|Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||Percentage of Participants|||Number
1282597|NCT00242567|Secondary|Time to Occurrence of Skeletal Related Event or Death|Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.|18 Months|The ITT Population consisted of all patients randomized to treatment.|||Days||95% Confidence Interval|Median
1282598|NCT00242567|Secondary|Overall Survival at 18 Months and 3 Years|Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.|month 18, year 3|The ITT Population will consist of all patients randomized to treatment.|||participants|||Number
1282599|NCT00242567|Primary|Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer|Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.|18 months|The ITT Population will consist of all patients randomized to treatment.|||participants|||Number
1282600|NCT00242502|Primary|Progression-free Survival (PFS) Rate|Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to 16 weeks|Six participants were not evaluable.|||percentage of participants|||Number
1282601|NCT00242385|Secondary|Adverse Events (AEs)|"Investigators assessed severity of AEs (occurring during or after infusions) based on:~MILD: Transient discomfort, does not interfere in a significant manner with participant’s normal functioning level; Resolves spontaneously or may require minimal therapeutic intervention MODERATE: AE produces limited impairment of function, can require therapeutic intervention; AE produces no sequelae; SEVERE: AE results in marked impairment of function, can lead to temporary inability to resume usual life pattern; AE produces sequelae, which require prolonged therapeutic intervention"|Throughout study period (7 months)|Safety Analysis Data Set - all study subjects who had evidence of receiving at least one dose of study medication regardless of any protocol violation.|||Events|||Number
1282602|NCT00242385|Secondary|Incremental Recovery|Computed from Cmax (mg/ml) divided by dose per kg body weight (mg/kg).|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||(mg/mL) / (mg/kg)||Full Range|Median
1282603|NCT00242385|Secondary|Time to Maximum α1-PI Concentration Post-infusion (Tmax)|Time to reach C-max. Tmax is the number of days from infusion to maximum concentration. Samples drawn at the end of infusion are considered to be time zero.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days||Full Range|Median
1282604|NCT00242385|Secondary|Maximum Plasma Concentration (Cmax)|Maximum α1-PI concentration following infusion|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||mg/mL||Full Range|Median
1282605|NCT00242385|Secondary|Terminal Half-life|Computed from the terminal or disposition rate constant obtained from log_e -linear fitting using the least squares deviation to the last five quantifiable concentrations above pre-infusion level.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days||Full Range|Median
1282606|NCT00242385|Secondary|Apparent Volume of Distribution at Steady State|Computed as weight-adjusted CL * MRT|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||mL||Full Range|Median
1282607|NCT00242385|Secondary|Mean Residence Time (MRT)|Computed as total area under the moment curve (AUMC) divided by total AUC|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days||Standard Deviation|Mean
1282608|NCT00242385|Secondary|Systemic Clearance (CL)|Computed as dose divided by AUC 0-infinity (AUC 0-infinity was calculated as the sum of AUC from time 0 to the time of last quantifiable concentration plus a tail area correction)|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||mL/day||Full Range|Median
1282609|NCT00242385|Secondary|Total Area Under the Curve Per Dose|Total area under the α1-PI concentration vs. time curve from pharmacokinetic day 0 to time infinity (AUC 0-infinity) per dose|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days*kg/mL||Full Range|Median
1282610|NCT00242385|Primary|Area Under the Curve/Dose|Area under the plasma alpha1-proteinase inhibitor (α1-PI) concentration versus time curve (AUC) calculated by linear trapezoidal method per dose.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|All study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days*kg/mL||Full Range|Median
1282611|NCT00242216|Secondary|CD4 Cell Count Change From Baseline During Treatment.||24 weeks.||||cell/mm3||Standard Deviation|Mean
1282612|NCT00242216|Primary|Proportion of Patient With Viral Load Less Than 400 Copies/mL||24 weeks||||percentage|||Number
1282627|NCT00241644|Secondary|Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects|An initially seronegative subject is a subject whose IgA antibody concentration was below the assay cut-off value of 20 Units per milliliter (U/mL) before administration of the first vaccine dose.|One month after the last vaccine dose|Analysis was performed on the ATP cohort for immunogenicity, only for initially seronegative subjects.|||Units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
1282613|NCT00241969|Primary|Change in Height for Age Z-Score (HAZ) From Baseline to Follow Up|"This outcome measure examines the change in height for age Z-score (HAZ) from baseline to follow up. Height was measured standing unless the child was unwilling to stand, then a supine measurement was obtained. All measurements were obtained in triplicate and then the mean used for analyses.~Height for age Z score was calculated using the mean measurement and the Centers for Disease Control and Prevention Anthropometric Software Program. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean."|18 months||||Z-score||Standard Deviation|Mean
1282614|NCT00241969|Primary|Change in Weight for Age Z-Score (WAZ) From Baseline to Post Treatment|"This outcome measure examines the change in weight for age Z-score (WAZ) from baseline to post treatment. Weight was measured in kilograms, measured to the nearest 100 grams, obtained using a digital scale by trained study staff. All measurements were obtained in triplicate and then the mean used for analyses.~Weight for age Z score was calculated using the mean measurement and the Centers for Disease Control and Prevention Anthropometric Software Program. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean."|6 months||||z-score||Standard Deviation|Mean
1282615|NCT00241969|Primary|Change in Energy Intake From Baseline to Post Treatment|This primary outcome measure compared change in energy intake from baseline to post treatment between the behavioral and nutrition treatment and the education and attention control treatment. Energy intake was assessed using a 7-day diet diary recorded by parents and analyzed using Nutrition Data System for Research Software, Version 2011. Data were examined as average kilocalories per day over the 7 day period at baseline and post treatment. The mean (SD) change in energy intake was compared between baseline to post treatment was|6 months||||kilocalories per day||Standard Deviation|Mean
1282616|NCT00241904|Secondary|Patients' Satisfaction With Care and Health Care Utilization|Patient satisfaction with care and healthcare utilization was measured with the Patient Assessment for Chronic Illness Care Scale (PACIC). The scores range from 0-5, with 5 being the most satisfied|Measured at 1 year||||units on a scale||Standard Deviation|Mean
1282617|NCT00241904|Primary|HbA1c|Fasting for 12 hour blood sample was measured in standardized lab|Measured at 1 year|Only the participants with a diagnosis of diabetes were assessed for this outcome measure|||percentage of hemoglobin||Standard Deviation|Mean
1282618|NCT00241904|Primary|Systolic Blood Pressure|Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association.|Measured at 1 year||||mmHg||Standard Deviation|Mean
1282619|NCT00241904|Primary|Low-density Lipoprotein Cholesterol|Blood was drawn after a 12 hour fast and low density lipoprotein cholesterol was measured in a standardized lab|Measured at 1 year||||mg/dL||Standard Deviation|Mean
1282620|NCT00241839|Secondary|Change in Uric Acid (UA) Levels: Baseline Less End of Treatment|Subjects on allopurinol are expected to lower their uric acid levels relative to placebo.|Baseline UA levels compared to end of treatment levels (8-10 weeks on allopurinol / placebo)|Change in uric acid from baseline to end of treatment.|||mg/dl||Standard Deviation|Mean
1282621|NCT00241839|Secondary|Change in Overall Mean BP From Those Obtained by 24 Hour Ambulatory Blood Pressure Measurements (ABPM) 8-10 Weeks Minus Baseline.|Subjects had 24 hr blood pressure monitoring (ABPM) at baseline and treatment end. The readings were averaged and the changes from baseline to treatment end were compared.|Baseline and end of treatment (8-10 weeks on allopurinol / placebo)|We obtained over 90% of those with cuff measures on the 24 hour BP measures (ABPM).|||mm Hg||Standard Deviation|Mean
1282622|NCT00241839|Primary|Change in Systolic Blood Pressure by Cuff After 8-10 Weeks Minus Baseline|"The systolic BP was taken at Baseline and after 8-10 weeks of treatment on placebo, while on chlorthalidone and potassium chloride. The blood pressure was measured according to Shared Care protocol: 15 minutes of quiet, undisturbed rest with three BP measurements obtained subsequently at 5 minute intervals.~The mean of the second and third reading was the value used for analysis for both the Baseline measurement and the measurement after 8 - 10 weeks of treatment. The dependent variable is baseline value minus ending value.~Measures are in millimeters of mercury (mm hg)"|Measured at 8-10 weeks on allopurinol or placebo|Participants were individuals with essential hypertension (BP 140/90-160/100) on none or up 2 antihypertensive drugs without any other chronic condition or illness. For their data to be included in analysis they had to complete the study (includes baseline to last visit).|||mm Hg||Standard Deviation|Mean
1282623|NCT00241839|Primary|Change in Diastolic Blood Pressure by Cuff 8-10 Weeks Minus Baseline|"The Diastolic BP was taken at Baseline and after 8-10 weeks of treatment or placebo while on chlorthalidone and potassium chloride. The blood pressure was measured according to Shared Care protocol: 15 minutes of quiet, undisturbed rest with three BP measurements obtained subsequently at 5 minute intervals.~The mean of the second and third reading was the value used for analysis for both the Baseline measurement and the measurement after 8 - 10 weeks of treatment. The dependent variable is baseline value minus ending value.~Measures are in millimeters of mercury (mm hg)"|Measured at 8-10 weeks on allopurinol / placebo|Participants were individuals with essential hypertension (BP 140/90-160/100) on none or up 2 antihypertensive drugs without any other chronic condition or illness. For their data to be included in analysis they had to complete the study (includes baseline to last visit).|||mm Hg||Standard Deviation|Mean
1282624|NCT00241644|Secondary|Number of Seropositive Subjects|Seropositive subjects are defined as subjects with anti-rotavirus IgA antibody concentration ≥ 20 U/mL.|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity.|||subjects|||Number
1282625|NCT00241644|Secondary|Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies|Geometric mean concentrations are given as Units per milliliter (U/mL).|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity.|||U/mL||95% Confidence Interval|Geometric Mean
1282626|NCT00241644|Secondary|Number of Seroconverted Subjects|Seroconverted subjects are defined as subjects with appearance of anti-rotavirus IgA antibody concentration ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of vaccine or placebo) seronegative for rotavirus.|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity, only for inititally seronegative subjects.|||subjects|||Number
1282628|NCT00241644|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the first dose of vaccine or placebo up to end of the study||||subjects|||Number
1282629|NCT00241644|Secondary|Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From the first dose of vaccine or placebo up to end of the study||||subjects|||Number
1282630|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|During the period from 1 year of age to study end|The analysis was performed on the ATP cohort for efficacy of the second efficacy period.|||subjects|||Number
1282631|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.|||subjects|||Number
1282632|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|During the period from 1 year of age to study end|The analysis was performed on the ATP cohort for efficacy of the second efficacy period.|||subjects|||Number
1282633|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.|||subjects|||Number
1282634|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|During the period from 1 year of age to study end|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the second efficacy period.|||subjects|||Number
1282635|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the combined efficacy follow-up periods.|||subjects|||Number
1282636|NCT00241644|Secondary|Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy|||subjects|||Number
1282637|NCT00241644|Secondary|Number of Subjects Reporting Severe Gastroenteritis of Any Cause|Number of subjects with gastroenteritis (three or more looser than normal stools or watery stools within a day) that scored ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy.|||subjects|||Number
1282638|NCT00241644|Secondary|In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the third dose of vaccine or placebo up to 1 year of age|"Analysis was performed on the ATP cohort for efficacy, only for the subset of subjects in South Africa who were fully vaccinated before the beginning of the rotavirus season.~For this analysis, data from Rotarix 2-dose Group and Rotarix 3-dose Group were pooled into one group (Rotarix pooled Group)."|||subjects|||Number
1282639|NCT00241644|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From the first vaccine or placebo dose up to 1 year of age||||subjects|||Number
1282640|NCT00241644|Secondary|Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy|||subjects|||Number
1282641|NCT00241644|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy|||subjects|||Number
1282642|NCT00241644|Primary|Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy|||subjects|||Number
1282643|NCT00241358|Secondary|To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity|-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion|0 to 24 hours after dose of IV AMD3100|Pharmacokinetics were not performed on 2 patients who were considered replacement patients.|||ng*hr/mL||Full Range|Mean
1282644|NCT00241358|Secondary|To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax|-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion|0 to 24 hours after dose of IV AMD3100|Pharmacokinetics were not performed on 2 patients who were considered replacement patients.|||ng/ml||Full Range|Mean
1282645|NCT00241358|Secondary|Proportion of Donors Who Experience Infusional Toxicity (Donor Only)|-Defined as hypersensitivity reactions. Evaluated by physical exam, blood pressure, heart rate, respirations and temperature one hour prior to the infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours post-infusion|Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm)||||Participants|||Count of Participants
1282646|NCT00241358|Secondary|Quality of Life During Stem Cell Mobilization (Recipients Only)||48-72 hours after last dose of AMD3100|-Quality of life questionnaires were not collected from the recipients.||||||
1282647|NCT00241358|Secondary|Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)|-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause|100 days after transplant|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.|||Participants|||Count of Participants
1282648|NCT00241358|Secondary|Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)|-Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria|Between Day +100 and +365 post-transplant|Only 28 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, receiving non-AMD3100 mobilized cells, or death before day +100.|||Participants|||Count of Participants
1282649|NCT00241358|Primary|Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)|-Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir|Day +21|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.|||Participants|||Count of Participants
1282650|NCT00241358|Primary|Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)|-Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria|By Day 100 after transplant|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.|||Participants|||Count of Participants
1282651|NCT00241358|Primary|Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only)|-Defined as the proportion of donors collecting >2.0x106 CD34+ cells/kg [recipient weight]|Day 1-3||||Participants|||Count of Participants
1282652|NCT00241280|Primary|Rate of Contact Lens Related Serious and Significant Events (SSE)|The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.|Throughout the duration of the study (1 Year)|All subjects that were dispensed a study lens.|||percentage of Subjects|||Number
1282653|NCT00241280|Primary|Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40|Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.|Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks|The analysis population consists of subjects that completed all study visits, without a major protocol deviation. The analysis was conducted on these subject eyes.|||Percentage of Subjects Eyes|Participants||Number
1282654|NCT00241176|Secondary|Clinical Global Impression Severity Scores|The Clinical Global Impression scale (CGI) is a classic instrument for making global assessments. This scale yields three different measures: 1. Severity of illness (7-point scale, with 7 being the most impaired; assessment of patient's current symptom severity, referred to here as CGIs), 2. Global improvement (7-point scale, with 7 being the most impaired; comparison of patient's baseline condition with his/her current condition, referred to here as CGIi), 3. Efficacy index (4 point x 4 point rating scale, comparison of patient's baseline condition with a ratio of current therapeutic benefit to severity of side effects)|24 Months||||units on a scale||Standard Deviation|Mean
1282655|NCT00241176|Primary|Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)|The Yale Global Tic Severity Scale (YGTSS) is a clinical rating instrument that was designed for use in studies of Tourette's syndrome and other tic disorders. The YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics.|8 Weeks||||units on a scale||Standard Deviation|Mean
1282656|NCT00240994|Primary|The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation|Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.|Up to one year post kidney transplantation procedure|Intent-to-treat|||Proportion of participants|||Number
1282657|NCT00240981|Secondary|50-Meter Walking Speed (With a Load)|Change from baseline 50-Meter Walking Speed (with a load) at 6 months|baseline and 6 months|Participants with a baseline and one post baseline measure.|||meters/second||95% Confidence Interval|Mean
1282658|NCT00240981|Secondary|Total Fat Mass||baseline, 3 months, and 6 months||||Kilograms||Standard Deviation|Mean
1282659|NCT00240981|Secondary|Total Lean Mass||baseline, 3 months, and 6 months||||Kilograms||Standard Deviation|Mean
1282660|NCT00240981|Secondary|Late Life Functional Disability Index (LLFDI)|Percent change from baseline in the late life functional disability index at 6 months|baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
1282661|NCT00240981|Secondary|Stair-climbing Test (Loaded)|Change from baseline in Stair-climbing Test (loaded)|baseline and 6 months|Participants with one baseline and one post baseline measure.|||Watts||95% Confidence Interval|Mean
1282662|NCT00240981|Secondary|50-Meter Walking Speed (Without a Load)|Change from baseline 50-Meter Walking Speed (without a load) at 6 months|baseline and 6 months|Participants with a baseline and one post baseline measure.|||meters/second||95% Confidence Interval|Mean
1282663|NCT00240981|Secondary|Grip Strength|Change from baseline in grip strength in the dominant hand.|baseline and 6 months|The participants with baseline and one post baseline measure are included.|||Kilograms||95% Confidence Interval|Mean
1282664|NCT00240981|Secondary|Stair-climbing Test (Without a Load)|Change from baseline in the stair-climbing test (without a load) at 6 months.|baseline and 6 month|Participants with baseline and one post baseline measure.|||Watts||95% Confidence Interval|Mean
1282665|NCT00240981|Secondary|Chest-Press|Change from baseline in chest press strength at 6 months|baseline and 6 months|Participants with baseline and 1 post baseline measure.|||Newtons||95% Confidence Interval|Mean
1282666|NCT00240981|Primary|Changes in Physical Performance Measured by an Exercise Testing Regimen|Primary outcome was a change from baseline in leg-press strength at 6 months.|baseline and 6 months|Participants with baseline and at least one post baseline measure.|||Newtons||95% Confidence Interval|Mean
1282667|NCT00240539|Primary|Number of Subjects With Chronic and With Clinical HBV Infection|"Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points.~Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point."|From year 16 through to year 20||||subjects|||Number
1282668|NCT00240539|Primary|Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus|Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).|At Years 16, 17, 18,19 and 20 after primary vaccination|The analyses were performed on the ATP cohort for immunogenicity. Only subjects positive for HBsAg or anti-HBc markers were tested for HBeAg and anti-HBe markers for Year 17 to Year 20.|||subjects|||Number
1282669|NCT00240539|Primary|Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.|At Years 16, 17, 18, 19 and 20 after primary vaccination|The analyses were performed on the Long-Term According to protocol (ATP) cohort for immunogenicity. Due to subjects being lost to follow up or eliminated from the ATP cohort for immunogenicity, no data from subjects in HBsAg(+) & HBeAg(-) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group were analyzed.|||subjects|||Number
1282670|NCT00240526|Primary|Number of Subjects With Different Hepatitis B Infection Statuses|"Categories hepatitis B (HB) infection:~Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples~False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg.~Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples.~Isolated natural booster: >4-fold increase of anti-HBs concentrations if <100 mIU/mL at previous sample OR >2- fold increase of anti-HBs concentrations if >=100 mIU/mL at previous sample + other markers neg"|Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)|Analysis was performed on the Long Term Total Cohort (LT total cohort). The maximum amount of subjects who have participated in any of the time points in this study has been given as number of participants analyzed.|||subjects|||Number
1282671|NCT00240526|Primary|Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection|Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on the Long Term Total Cohort (LT total cohort) on subjects with available data for the specified marker.|||subjects|||Number
1282692|NCT00240227|Secondary|Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session|Study was terminated early. No final analyses completed.||||||
1282672|NCT00240526|Primary|Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)|"Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.~Note: Missing CLIA anti-HBs concentrations, for subjects with ELISA results available, are estimated by multiple imputations and GMCs and number of subjects were adjusted for these imputations."|At Years 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||Subjects|||Number
1282673|NCT00240526|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).|Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||subjects|||Number
1282674|NCT00240526|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).|"Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).~Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL."|At Years 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||mIU/mL||95% Confidence Interval|Geometric Mean
1282675|NCT00240526|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|"Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).~Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL."|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||mIU/mL||95% Confidence Interval|Geometric Mean
1282676|NCT00240500|Primary|Clinical Review for Hepatitis B Infection Status|Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points|Over the entire 4 year follow up period (17 - 20 years)||||participants|||Number
1282677|NCT00240500|Primary|Prevalence of Serological Markers for Hepatitis B Infection|It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg & anti-HBe|Years 17, 18, 19 and 20.||||Percentage of participants (%)|||Number
1282678|NCT00240500|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.|Years 17, 18, 19 and 20.||||mIU/mL||95% Confidence Interval|Mean
1282679|NCT00240487|Primary|Mean PaO2/FiO2 Ratio|Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared|8 hours||||mmHg||Standard Deviation|Mean
1282680|NCT00240331|Secondary|Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
1282681|NCT00240331|Secondary|Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
1282682|NCT00240331|Secondary|Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
1282683|NCT00240331|Secondary|Number of Randomised Participants That Died From Non Cardiovascular Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||||||
1282684|NCT00240331|Secondary|Number of Randomised Participants That Died From Cardiovascular Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
1282685|NCT00240331|Secondary|Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
1282686|NCT00240331|Secondary|Number of Randomised Participants That Died From Any Cause.||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
1282687|NCT00240331|Primary|Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
1282688|NCT00240227|Secondary|Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods||4 weeks|Study was terminated early. No final analyses completed.||||||
1282689|NCT00240227|Secondary|Change in Self-reports of Substance Use Between Study Medication and Placebo Periods||4 weeks|Study was terminated early. No final analyses completed.||||||
1282690|NCT00240227|Secondary|Change in Subjective Experience of Craving in Response to Provocative Visual Cues Designed to Elicit Craving, as Measured by the Within Session Rating for Cocaine/Alcohol Craving||During lab session|Study was terminated early. No final analyses completed.||||||
1282691|NCT00240227|Secondary|Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session|Study was terminated early. No final analyses completed.||||||
1282695|NCT00240162|Secondary|Safety and Tolerability of PTK787/ZK 222584|Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.|30 days after treatment ends [median of 15 cycles (11-32)]|Only 13 out of the 21 participants experienced a grade 3 or 4 adverse event.|||adverse events|||Number
1282696|NCT00240162|Secondary|Time to Progression|"Time to progression is from the start of treatment until the first date that criteria for progressive disease (PD) are met.~25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL and confirmed by at lease 1 repeated investigation.~25% increase in the 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/ 24 hr and confirmed by at least 1 repeated investigation.~35% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.~Increase in the size of existing bone lesions or soft tissue plasmacytomas~New lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression).~Hypercalcemia - corrected serum calcium > 11.5 mg/dL"|Until the patient progresses or expires (up to 457 days)|Participants were evaluable for time to progression if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.|||days||Full Range|Median
1282697|NCT00240162|Primary|Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug||Day 90|Participants were evaluable for response if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.|||participants|||Number
1282698|NCT00240110|Secondary|Change From Baseline in Percentage of Money Spent on Cocaine|Change from baseline in percentage of the amount of money spent on cocaine|week 12|All subjects with available data after assignment to study medications|||Percentage of Money Spent on Cocaine||Standard Deviation|Mean
1282699|NCT00240110|Primary|Change From Baseline in Percentage of Cocaine-abstinent Days|Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)|Week 12|All subjects with available data after assignment to study medications|||percentage of days cocaine abstinent||Standard Deviation|Mean
1282700|NCT00240097|Primary|Response Rate After Relapse|The objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) – IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.|3 weeks after 3rd cycle of starting therapy after relapse or refractory disease|All subjects dropped out or died prior to experiencing relapse||||||
1282701|NCT00240097|Secondary|Overall Survival (Part I)|Length of subject survival after starting study treatment|baseline to 2 years||||months||95% Confidence Interval|Median
1282702|NCT00240097|Primary|Objective Response Rate (Part I)|The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) – IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.|baseline to 18 months||||Participants|||Number
1282703|NCT00240097|Secondary|Progression Free Survival (Part I)|Time to progressive disease|baseline to five years||||months||95% Confidence Interval|Median
1282704|NCT00240071|Secondary|The Secondary Efficacy Outcome Will be Objective Response Rate (Defined as the Rate of Complete and Partial Responses.||Determined on two consecutive occasions at least 4 weeks apart.||||participants|||Number
1282705|NCT00240071|Primary|Progression Free Survival (PFS)|Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.|From date of registration until disease progression or death, whichever occurs first|All participants entered onto study (intention to treat) (ITT) were analyzed.|||days||95% Confidence Interval|Median
1282706|NCT00239928|Primary|Summary of Adverse Events|Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events|Week 54 (initiation of A5751015 study) up to Week 198|Intent-to-treat|||participants|||Number
1282707|NCT00239928|Secondary|Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)|Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"|||participants|||Number
1282708|NCT00239928|Secondary|Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)|Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT 00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"|||participants|||Number
1282709|NCT00239928|Secondary|Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)|Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"|||participants|||Number
1282710|NCT00239928|Secondary|Number of Responders|Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.~Last Observation Carried Forward"|||participants|||Number
1282711|NCT00239928|Secondary|Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point|"Value at each observation time point minus value at Week 54 (initiation of current study).~Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0."|Weeks 54, every 18 weeks from Week 54 up to Week 198|"Intent-to-treat, Among 61 subjects, for efficacy analyses, 1 subject had missing data at Week 72.~Last Observation Carried Forward"|||letters||Standard Deviation|Mean
1282712|NCT00239928|Secondary|Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point|"Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202).~Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0."|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.~Last Observation Carried Forward"|||letters||Standard Deviation|Mean
1282713|NCT00239837|Secondary|Decision Making|“Cups” task (Weller et al., 2007). On each trial, participants see 2 arrays with equal number of X cups (2, 3, or 5) each. On gain trials, participants informed that under each cup in one array is 1 quarter, and the other array includes 1 cup with Y quarters (either 2, 3, or 5), but the other cups have 0 quarters. Choosing from the riskless side leads to a sure gain of 1 quarter while choosing the risky side can lead to gain of Y quarters or no quarters. On loss trials, participants shown that choosing cup from 1 array will lead to 1 quarter taken away while choosing cup from other array will lead to no quarters or Y quarters taken. Cups task consists of 54 trials of 3 trials each of all combinations of 2 levels of domain (gain, loss). Expected Value Sensitivity (EV) calculated by subtracting proportion of risky choices made when EV actually favored the sure choice from proportion of risky choices made on trials where EV favored risky option. Score can range from -1.0 to -1.0.|Measured at age 15-17||||units on a scale||Standard Deviation|Mean
1282714|NCT00239837|Primary|Marijuana Use|The girls were asked how many times in the past year they had used marijuana. The response scale ranged from 1 (never) through 9 (daily). Units on a scale. Log transformed.|Measured at Month 36|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||log(units on a scale)||Standard Deviation|Mean
1282715|NCT00239837|Primary|Tobacco Use|The girls were asked how many times in the past year they had smoked cigarettes or chewed tobacco. The response scale ranged from 1 (never) through 9 (daily). Units on a scale.|Measured at Month 36|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||log(units on a scale)||Standard Deviation|Mean
1282716|NCT00239837|Secondary|Placement Changes|Child welfare system records were collected at each assessment to determine the girls’ placement changes (including the number and type of changes). Placement changes since the start of the study through 12 months were summed for each girl. The number of placement changes ranged from 0 to 7 during this period. Units on a scale. Higher scores indicate more placement changes.|Measured at Months 6 and 12|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||placement changes||Standard Deviation|Mean
1282717|NCT00239837|Secondary|Social Competence|Prosocial behavior was measured with a subscale from the Parent Daily Report (PDR; Chamberlain & Reid, 1987). The PDR was administered individually by telephone to foster parents on 3 consecutive or closely spaced days (1–3 days apart) at each assessment. A trained interviewer asked the foster parent whether a list of prosocial behaviors took place during the previous 24 hr (yes/no format). The prosocial scale was computed based on nine items, such as “cleans up after herself” and “do a favor for someone.” The PDR was designed to avoid the potential bias of aggregate recall of frequency estimates. Studies have reported concurrent and predictive validity of the PDR checklist. The scores were averaged (mean) across calls from 3 days. Scores on prosocial behavior at 6 and 12 months were averaged and the mean across both time points was used in analysis. Units on a scale. Range = 0-9. Higher scores indicate more prosocial behavior.|Measured at Months 6, 12|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||units on a scale||Standard Deviation|Mean
1282718|NCT00239837|Secondary|Participation in Risky Sexual Behaviors|Eight items from the girls’ in-person interviews were used to assess health risking sexual behavior at the 36-month followup. The girls reported on items such as touching a boy’s body above or below the waist, having sexual intercourse, having sex with someone who they just met, or having sex with someone using drugs in the past 12 months. Positive answers to these items were totaled to represent the cumulative number of health-risking sexual behaviors. The frequency of the cumulative number of risky sexual acts ranged from 0 to 7. Units on a scale. Higher scores indicate more health-risking sexual behaviors.|Measured at Month 36|FIML analysis includes estimation of all cases even when missing data are present|||units on a scale||Standard Deviation|Mean
1282719|NCT00239837|Secondary|Mental Health Problems|Internalizing and externalizing symptoms at 12 and 24 months were measured with caregiver report on the Achenbach System of Empirically Based Assessment (ASEBA). This widely used checklist for psychopathological behaviors includes scales for behaviors such as Anxious/Depressed; Withdrawn; Somatic Complaints; Thought Problems; Attention Problems; Aggressive Behavior; Rule-Breaking Behavior; and Intrusive. The ASEBA has been shown to have both construct and content validity in the literature. For the present study, raw scores for the internalizing and externalizing symptoms subscales were used. Scores at 12 and 24 months were combined and averaged (mean). Units on a scale. Range = 0-66. Higher scores indicate higher levels of internalizing or externalizing problems.|Measured at Months 12 and 24|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||units on a scale||Standard Deviation|Mean
1282720|NCT00239837|Primary|Delinquency|36 items from the general delinquency scale from the Self-Report Delinquency Scale (SRD; Elliott, Huizinga, & Ageton, 1985). Units on a scale. Girls were asked to rate how many times they had committed various delinquent acts (e.g., damaging or destroying properties, and stealing) in the past year, using an open-ended format. The mean of frequencies across these items was used to represent the level of delinquency for girls. The general delinquency scale scores ranged from 0 to 24 (full scale) and from 0 to 13 (log transformed). Higher scores indicate higher levels of delinquency.|Measured at Month 36|FIML analysis includes estimation of all cases even when missing data are present|||log(units on a scale)||Standard Deviation|Mean
1282721|NCT00239733|Primary|Absolute Change in Platelet Count From Baseline||Through Week 12||||Participants|||Count of Participants
1282722|NCT00239733|Primary|Frequency and Severity of Adverse Events||Throughout study, for up to 12 weeks||||Participants|||Count of Participants
1282723|NCT00239720|Primary|Proportion of Participants Who Received at Least Two Cycles of Treatment and Who Showed Predefined Levels of Improvement in Primary Efficacy Parameter at Six Months|"Participants who improve by at least 1 unit from baseline in either the physician or participant global assessment and have at least 30% improvement from baseline in either tender or swollen joint scores[1] at 6 months from start of treatment and received at least 2 cycles of treatment~The tender and swollen joint scores assess 68 and 66 joints, respectively, with each joint rated from 0 to 3. Total scores range from 0-204 for tenderness and 0-198 for swelling, with higher scores indicating more severe symptoms[2].~Ref: Clegg DO et al. Arthritis Rheum. 1996; 39(12):2013-20."|6 Months|Intent-to-treat||||||
1282724|NCT00239681|Secondary|Time to Bone Fracture|Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean|Up to 5 years|Intention to treat population|||Days||Standard Error|Mean
1282725|NCT00239681|Secondary|Time to Venous Thromboembolic Event|Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||Days||Standard Error|Mean
1282726|NCT00239681|Secondary|Time to Development of Diabetes Mellitus|Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||Days||Standard Error|Mean
1282727|NCT00239681|Secondary|Time to Non-cardiovascular Death|Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||Days||Standard Error|Mean
1282728|NCT00239681|Secondary|Time to Death Due to Any Cause|Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||days||Standard Error|Mean
1282729|NCT00239681|Primary|Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)|Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||Days||Standard Error|Mean
1282730|NCT00239642|Secondary|Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline|Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline|anytime during the 12 week post-baseline period|mITT subjects|||percentage of subjects|||Number
1282731|NCT00239642|Secondary|Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline|Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline|anytime during the 12 week post-baseline period|mITT subjects|||participants|||Number
1282732|NCT00239642|Secondary|Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive|Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive|anytime during the 12 week post-baseline period|mITT subjects|||percentage of subjects|||Number
1282733|NCT00239642|Secondary|Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive|Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive|anytime during the 12 week post-baseline period|mITT subjects|||participants|||Number
1282734|NCT00239642|Secondary|Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|anytime during the 12 week post-baseline period|mITT subjects|||percentage of subjects|||Number
1282735|NCT00239642|Secondary|Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive|anytime during the 12-week post-baseline period|mITT subjects|||participants|||Number
1282736|NCT00239642|Secondary|Percentage (%) of Subjects Achieving Clinical Success|Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)|anytime during the 12 week post-baseline period|mITT subjects|||percentage of subjects|||Number
1282737|NCT00239642|Secondary|Number of Subjects Achieving Clinical Success|Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)|anytime during the 12 week post-baseline period|mITT subjects|||participants|||Number
1282738|NCT00239642|Primary|Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event|Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm|baseline through week 12|Safety Population - Subjects who received at least 1 dose of study drug.|||participants|||Number
1282755|NCT00239226|Primary|Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group|Persistent Atrial Fibrillation (AF) incidence|1 year|97 pts completed the study after a mean fu period of 15±7 months.|||Number of patients with persistent AF|||Number
1282739|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population|Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: >= 120 beats per minute (bpm) and increased >= 15 bpm; sinus bradycardia: <= 50 bpm and decrease >= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) >= 0.20 seconds (sec) and increase >= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) >= 0.12 sec and increase >= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) >= 450 milliseconds (msec) and elevation of 10% over baseline.|Baseline to end of study (Week 348|Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each ECG parameter and includes those treated participants with ECG measurements.|||participants|||Number
1282740|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population|Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (>=) 20; decrease of >= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of >= 15; decrease of >= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase >=15; decreased >= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each vital sign parameter and includes those treated participants with vital sign measurements.|||participants|||Number
1282741|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population|Clinically relevant laboratory abnormality: Hemoglobin male <= 11.5 g/dL; female <= 9.5 g/dL. Hematocrit male <= 37 and 3 point decrease from baseline (BL); female <=32 and 3 point decrease from BL. Leukocytes <= 2800 mm^3 or >= 16000 mm^3; eosinophils >=10%. Baseline is Day 1 of the study, prior to study drug administration.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.|||participants|||Number
1282742|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population|Clinically relevant abnormalities: greater than, equal to (>=); less than, equal to (<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT>= 3*ULN; aspartate aminotransferase (AST >=3*ULN; alkaline phosphatase >=3*ULN; total bilirubin >= 2.0 mg/dL; blood urea nitrogen >= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine >=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male >= 10.5, female >= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.|||participants|||Number
1282743|NCT00239356|Secondary|Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population|Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.|Day 1 to Day 1170|N=number of participants receiving drug at Days indicated.|||mg/day||Full Range|Mean
1282744|NCT00239356|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Baseline to Week 348|Safety Population: all participants with at least 1 dose of study drug.|||participants|||Number
1282745|NCT00239356|Primary|Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.|Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.|Baseline to Week 348|Safety Population - all participants who received at least one dose of drug. N=number of participants who were analyzed at each specific time point. Baseline N=97, 20 for first and second arms, respectively.|||units on a scale||Standard Deviation|Mean
1282746|NCT00239226|Secondary|Ventricular Pacing Percentage||January 2009|||||||
1282747|NCT00239226|Secondary|AF Burden||January 2009|||||||
1282748|NCT00239226|Secondary|Number of Episodes/Day||January 2009|||||||
1282749|NCT00239226|Secondary|Time to First Persistent Episode of Atrial Fibrillation (AF)||January 2009|||||||
1282750|NCT00239226|Secondary|Heart Failure: Comparison Between All Groups||January 2009|||||||
1282751|NCT00239226|Secondary|Number of Cardioversion: Comparison Between All Groups||January 2009|||||||
1282752|NCT00239226|Secondary|Symptom Scale Questionnaire: Comparison Between All Groups||January 2009|||||||
1282753|NCT00239226|Secondary|Number of Patients With Permanent Atrial Fibrillation (AF)||January 2009|||||||
1282756|NCT00239005|Secondary|Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).|Health-related quality of life (HRQoL)was assessed by the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI also has five different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) producing a total score of the 36 items. Lower scores represent more dysfunction. A higher score represents a better quality of life (range from 0 to 144).|At week 3 and week 13 (last visit)|Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GIQLI questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.|||Units on a scale||Standard Error|Least Squares Mean
1282757|NCT00239005|Secondary|Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).|The GSRS is a 15-item instrument designed to assess the impact of upper and lower GI symptoms. There are five subscales: reflux, diarrhea, constipation, abdominal pain, and indigestion—each of which produces a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). A higher score represents greater impairment of quality of life due to GI symptoms (range from 1 to 7).|At week 3 and week 13 (last visit)|Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GSRS questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.|||Units on a scale||Standard Error|Least Squares Mean
1282758|NCT00239005|Primary|Mycophenolic Acid (MPA) Maintenance Treatment|The primary assessment was based on the percentage of patients who were maintained at week 13 on a dose at least one dose equivalent greater than at baseline (visit 2/week 1). A dose equivalent was defined as EC-MPS 180 mg/day or MMF 250 mg/day.|at week 13 (last visit)|The intent-to-treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable.|||Percentage of Patients||95% Confidence Interval|Number
1282759|NCT00238615|Primary|2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.|Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.|Two years|All patients alive and not censored at 2 years|||participants|||Number
1282760|NCT00238615|Other Pre-specified|Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen|This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.|Specimen collected at time of surgery|Plan was to analyze all patients with adequate tissue for this analysis, but was not done. We did not have sufficient funds for this analysis.||||||
1282761|NCT00238615|Secondary|Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival|The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.|baseline, 5 weeks after combined chemo-radiation|All enrolled patients were analyzed in the published manuscript|||standardized uptake value (SUV)max||Standard Deviation|Mean
1282762|NCT00238433|Primary|Therapy-Related Toxicities|The table presented below reflects how many participants (out of 36 total) presented an adverse event related to the treatment regimen within each toxicity category. To review specific adverse events, both related and unrelated to study treatment, please refer to Adverse Events Section.|Through 24 months post transplantation||||Participants|||Count of Participants
1282763|NCT00238433|Primary|Disease-Free Survival|The data presented below represents the total number of subjects (out of 36) that reached disease-free survival status during Months 3, 6, 9, 12, 18, and 24 time points.|3, 6, 9, 12, 18, and 24 months post transplantation||||Participants|||Count of Participants
1282764|NCT00238420|Secondary|Five-year Overall Survival|Calculated using the Kaplan-Meier method.|From the date of treatment started to death, assessed up to at least 5 years||2019-05-31|05/2019||||
1282765|NCT00238420|Secondary|Five-year Disease-free Survival|Calculated using the Kaplan-Meier method.|From start of treatment progression to progression or death, assessed up to at least 5 years||2019-05-31|05/2019||||
1282766|NCT00238420|Secondary|Complete Response to Treatment|The number of patients within each group who achieved a complete response to protocol treatment by 12 weeks are reported. Complete response is defined as no gross tumor at cystoscopy or negative biopsies or both by week 12 after completion of protocol treatment.|At 12 weeks from treatment start|All eligible patients who started treatment and had an evaluation to assess response by 12 weeks|||percentage of participants||95% Confidence Interval|Number
1282767|NCT00238420|Secondary|Treatment Completion|The number of patients within each group who completed all elements of protocol treatment are reported.|From registration to end of treatment; up to 64 days.”|All eligible patients who started study treatment|||participants|||Number
1282780|NCT00238264|Secondary|Event-free Survival Probability|To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation|3 years|All eligible patients were included in the analysis, per protocol.|||Percentage 3-year EFS rate||95% Confidence Interval|Number
1282781|NCT00238264|Secondary|Progression-free Survival Probability|To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.|3 years|All eligible patients were included in the analysis, per protocol.|||Percentage 3-year PFS rate||95% Confidence Interval|Number
1282768|NCT00238420|Primary|Acute Treatment-related Toxicity|In each group, the number of patients was tabulated by type and grade (gr) of treatment-related toxicity (CTCAE v3.0). Only the following types of toxicity within 90 days of treatment start were considered: ≥ gr4 neutropenia, ≥ gr4 febrile neutropenia, ≥ gr3 diarrhea, ≥ gr3 nausea/vomiting, ≥ gr3 thrombocytopenia, ≥ gr3 renal, pulmonary, hepatic, or neurologic toxicity, ≥ gr3 rectal or genitourinary bleeding, ≥ gr3 left ventricular failure, or ≥ gr2 other cardiac toxicity. The study was designed to estimate the rate of acute treatment-related toxicity separately in each group of patients. Using the Fleming's one-sample multiple test procedure with Type I and II errors each set at 10%, 40 cases/group were required to reject the null hypothesis that the true toxicity rate is greater than 25% in favor of the alternative hypothesis that the true rate is no more than 10%. Six or more patients with the designated toxicities out of 40 would result in rejecting the null hypothesis.|From start of protocol treatment to 90 days|All eligible patients who started study treatment|||participants|||Number
1282769|NCT00238355|Secondary|Safety||duration of study|||||||
1282770|NCT00238355|Secondary|Duration of Survival up to 12 Weeks||up to 12 weeks|||||||
1282771|NCT00238355|Primary|Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.|Patients will be followed through day 84 (12 weeks), regardless of continuation of study drugs. Complete response: Resolution of all clinical signs and symptoms and more than 90 percent of the lesions due to invasive fungus that were visible by radiology. Partial response: Clinical improvement and greater than 50 percent improvement in the lesions due to invasive fungus that were visible by radiology.|12 weeks after starting treatment||||Participants|||Number
1282772|NCT00238303|Secondary|Time to Progression|"Estimated using Kaplan-Meier survival curve.~Definition of progression:~Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions."|From registration to disease progression (up to 5 years)|Stratum 1: 68 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was progression-free at last follow-up.|||months||Full Range|Median
1282773|NCT00238303|Secondary|Confirmed Tumor Response|"A confirmed tumor response will be defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations, which include neuroimaging, lasting during a period of at least 6 weeks. Confidence intervals for the true proportion will be calculated using the exact binomial method.~Bidimensionally measurable disease:≥50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Assessed up to 5 years|"Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.~Stratum 2: Since the patients underwent surgery, response is not applicable and hence 0 patients analyzed."|||percentage of participants||95% Confidence Interval|Number
1282774|NCT00238303|Secondary|Survival|Estimated using Kaplan-Meier survival curve.|From study registration to date of death due to any cause or last follow-up (up to 5 years)|Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was alive at last follow-up.|||months||Full Range|Median
1282775|NCT00238303|Primary|Proportion of Successes (Patients Alive and Progression-free)|"Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method.~Definition of progression:~Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions."|At 6 months|68 Stratum 1 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.|||percentage of participants||95% Confidence Interval|Number
1282776|NCT00238264|Secondary|Correlation MIB-1 Labeling Index With PFS|The primary methods of analysis will be via stratified Cox regression|Up to 10 years|All eligible patients with MIB-1 data available were included in this analysis. Per protocol, patients were stratified by age and tumor location. Based on a predefined cutoff, patients were categorized as MIB high or low (high: >= 2; low: < 2). The hazard ratio below is for patients with MIB high (low is the reference level).|||Hazard ratio||95% Confidence Interval|Number
1282777|NCT00238264|Secondary|MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods|The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.|At baseline|All eligible patients with MIB-1 labeling index available.|||percentage of tumor nuclei||95% Confidence Interval|Number
1282778|NCT00238264|Secondary|Quality of Life (QOL)|QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).|Up to 5 years|The QOL assessments were removed from the protocol as part of Amendment #1A (as of 10/27/2010) due to extremely low compliance. No QOL data were available for statistical analysis.||||||
1282779|NCT00238264|Secondary|Overall Survival Probability|To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.|3 years|All eligible patients were included in the analysis, per protocol.|||Percentage 3-year OS rate||95% Confidence Interval|Number
1282811|NCT00237692|Primary|Blood Pressure Averages Systolic & Diastolic|"Blood pressure measured at Baseline.~BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model."|Baseline||||mmHg||Standard Deviation|Mean
1282782|NCT00238264|Primary|Marginal-failure Rate|Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.|Up to 5 years|All evaluable patients were included in this analysis (n = 84). One eligible patient was deemed to be not evaluable due to progression during treatment, and was excluded from the analysis per protocol.|||percentage of failure rate|||Number
1282783|NCT00238238|Primary|Time to Progression|Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.|||years||95% Confidence Interval|Median
1282784|NCT00238238|Primary|Overall Response Rate|Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.|Duration of treatment (12 cycles)|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.|||percentage of participants||95% Confidence Interval|Number
1282785|NCT00238121|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions.|Up to 5 years||||Month||Full Range|Mean
1282786|NCT00238121|Secondary|Progression Free Survival|Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|Up to 5 years||||Month||95% Confidence Interval|Median
1282787|NCT00238121|Secondary|Overall Survival|Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.|Up to 5 years||||Month||95% Confidence Interval|Median
1282788|NCT00238121|Primary|Objective Overall Response Rate|Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.|Up to 5 years||||participants|||Number
1282789|NCT00238108|Secondary|Change in Systolic Blood Pressure|Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring|Measurement after 3 weeks of supplementation compared to baseline||||mmHg||Standard Error|Mean
1282790|NCT00238108|Primary|Sleep Quality|Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)|Measurement after 3 weeks of supplementation|One subject was removed from analysis because of an unstable dose of prescription medication.|||% (% asleep during 8 hour opportunity)||Standard Error|Mean
1282791|NCT00237809|Secondary|UCSD Performance-Based Skills Assessment (UPSA)|The UCSD Performance-Based Skills Assessment (UPSA) is a role-play test designed to evaluate a person’s functional capacity in two selected areas of basic living skills. These areas include Finance and Communication. Subjects being tested utilize props to demonstrate how they perform everyday activities and are assessed on their actual performance. The higher the score, the better the performance of an individual. The scores range from 0 to 100.|12 weeks||||units on a scale||Standard Deviation|Mean
1282792|NCT00237809|Secondary|Simpson-Angus Neurological Rating Scale|Simpson-Angus Scale (SAS) is a 10-item rating scale that has been used widely for assessment in both clinical practice and research settings. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The highest possible score is 40.|12 weeks||||units on a scale||Standard Deviation|Mean
1282793|NCT00237809|Secondary|Heinrichs-Carpenter Quality of Life Scale|The Heinrichs–Carpenter Quality of Life Scale is a testing device. It has a range of possible scores, 0–126 used to evaluate social functioning & behavior in patients with schizophrenia–lower scores represent poorer mental health.|12 weeks||||units on a scale||Standard Deviation|Mean
1282794|NCT00237809|Primary|Positive and Negative Syndrome Scale (PANSS)|The PANSS is a handscored instrument. It uses 25 PANSS items organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The PANSS is based on findings that schizophrenia comprises at least two distinct syndromes. The positive syndrome consists of productive symptoms, while the negative syndrome consists of deficit features. This distinction is useful when developing treatment plans because you can focus on the type of symptoms the patient is experiencing. It is also useful when studying the effects of medication (e.g., in clinical drug trials) because it allows you to determine which type of symptoms are being affected. PANSS Total score minimum = 30, maximum = 210. The greater the score, the greater the symptoms.|12 weeks||||units on a scale||Standard Deviation|Mean
1282795|NCT00237809|Primary|Spatial Span- Total Score|The Spatial Span subtest of the Wechsler Memory Scale can be used as an indicator of working memory and visuospatial processing. An increase in severity of impairment results in a decrease in Spatial Span Total Score. The range is 1 to 28.|12 weeks||||units on a scale||Standard Deviation|Mean
1282796|NCT00237809|Primary|Hopkins Verbal Learning Test|The Hopkins Verbal Learning Test is designed to assess verbal learning and memory (immediate recall, delayed recall, delayed recognition). The assessment takes approximately 5-10 minutes with a 25-minute delay to complete and 2 minutes to score. The greater the score, the greater the measured recall. The score ranges from 0 to 24.|12 weeks||||units on a scale||Standard Deviation|Mean
1282880|NCT00236184|Secondary|Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
1282797|NCT00237809|Primary|Wisconsin Card Sorting Test (WCST)|"The WCST allows the clinician to speculate to the following frontal lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding. The test can be administered to those from 6.5 years to 89 years of age.The test takes approximately 12–20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors. Can be interpreted as: the greater the percentage, the greater the measured ability."|12 weeks||||percentage of correct responses||Standard Deviation|Mean
1282798|NCT00237796|Secondary|Beck Anxiety Inventory (BAI)|The Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions. Scores from individual items are summed to yield a total score. The total score ranges from 0-63. Higher scores represent greater severity of anxiety.|baseline, mid-treatment, end of treatment, mid follow-up, and follow up||||units on a scale||Standard Deviation|Mean
1282799|NCT00237796|Secondary|Beck Depression Inventory-II (BDI-II)|The BDI-II is a self-report measure of depression that consists of 21 questions. The total scale ranges from 0-63. Scores from individual questions are summed to yield a total score. Higher scores represent greater severity of depression.|baseline, mid-treatment, end of treatment, mid follow-up, and follow-up||||units on a scale||Standard Deviation|Mean
1282800|NCT00237796|Secondary|The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation|The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22).|baseline, mid-treatment, end of treatment, mid follow-up, and follow-up||||units on a scale||Standard Deviation|Mean
1282801|NCT00237796|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression|The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13).|baseline, mid treatment, end of treatment, mid follow-up, and follow up||||units on a scale||Standard Deviation|Mean
1282802|NCT00237796|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility. Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms.|baseline, mid-treatment, end of treatment, mid follow-up, and followup||||units on a scale||Standard Deviation|Mean
1282803|NCT00237796|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|baseline, mid-treatment, end of treatment, mid-follow up, and follow up||||units on a scale||Standard Deviation|Mean
1282804|NCT00237796|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.|baseline, mid-treatment, end of treatment, mid-follow up, and follow up||||units on a scale||Standard Deviation|Mean
1282805|NCT00237770|Primary|Systolic Blood Pressure During Head-up Tilt|Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.|Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo.||||mmHg||Standard Deviation|Mean
1282806|NCT00237744|Primary|M1 Activation Absolute Change Score|A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.|at baseline and following 3 months of treatment|This is a sub sample of subjects eligible to undergo fMRI testing. A total of 23 subjects were eligible (5 subjects in the wrist/hand FES+ whole arm motor learning group; 8 subjects in the shoulder/elbow robotics+whole arm motor learning group and 10 subjects in the Whole arm motor learning group).|||voxels||Standard Deviation|Mean
1282807|NCT00237744|Primary|AMAT|The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.|prior to treatment and following 3 months of treatment||||seconds||Standard Deviation|Mean
1282808|NCT00237718|Secondary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.|month 6|The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.|||pg/ml||Standard Deviation|Mean
1282809|NCT00237718|Primary|F2-isoprostane (F2-iso)|F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.|month 6|The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.|||ng/ml||Standard Deviation|Mean
1282810|NCT00237692|Primary|Blood Pressure Averages Systolic & Diastolic|"Blood pressure measured at 12 month.~BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model."|12-month||||mmHg||Standard Deviation|Mean
1282881|NCT00236184|Secondary|Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
1282812|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 18 Months|When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|18 month||||% of particpants with controlled SBP|||Number
1282813|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 12 Months|When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|12 month||||% of particpants with controlled SBP|||Number
1282814|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 6 Months|When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|6month||||% of particpants with controlled SBP|||Number
1282815|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at Baseline|When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|Baseline||||% of particpants w/ controlled BP|||Number
1282816|NCT00237666|Secondary|Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)|Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
1282817|NCT00237666|Secondary|Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
1282818|NCT00237666|Secondary|Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint|Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Score on a scale||Standard Deviation|Mean
1282819|NCT00237666|Secondary|Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2|"Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.~18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial."|Week 8||||percentage of subjects with CGI-I </=2||95% Confidence Interval|Number
1282820|NCT00237666|Secondary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale|Montgomery–Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
1282821|NCT00237666|Secondary|Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)|Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
1282822|NCT00237666|Primary|The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores|Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
1282823|NCT00237458|Secondary|"Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration and Treatment Phases."|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|From Titration Phase through Treatment Phase (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 5 are included in this analysis.|||percentage of days||Standard Deviation|Mean
1282824|NCT00237458|Secondary|Percentage of Days With Concomitant Pain (“Rescue”) Medications Taken During Titration Phase.|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|Titration Period (approximately 6 weeks)|Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.|||percentage of days||Standard Deviation|Mean
1282882|NCT00236184|Secondary|Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
1282825|NCT00237458|Secondary|Percentage of Days With Concomitant Pain (“Rescue”) Medications Taken During Baseline Phase.|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|Baseline Period (approximately 1 week)|Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.|||percentage of days||Standard Deviation|Mean
1282826|NCT00237458|Secondary|Investigator's Global Impression of Change In Pain During The Treatment Period.|"The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:~Much better~Moderately better~Mildly better~No change~Mildly worse~Moderately worse~Much worse"|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||percentage of participants|||Number
1282827|NCT00237458|Secondary|Subject's Global Impression of Change In Pain During The Treatment Period.|"The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:~Much better~Moderately better~Mildly better~No change~Mildly worse~Moderately worse~Much worse"|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||percentage of participants|||Number
1282828|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.|"Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).~Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful."|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1282829|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1282830|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1282831|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1282832|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1282833|NCT00237458|Secondary|Within-Subject Change In Average Daily Pain Score During the Treatment Period.|The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1282834|NCT00237458|Primary|Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.||From Baseline Visit to Final Week of Treatment (approximately 10 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||participants|||Number
1282835|NCT00237458|Primary|Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.||From Baseline Visit to Final Week of Treatment (approximately 10 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||participants|||Number
1282836|NCT00237185|Secondary|Time to Progression (Core + Extension)|Time to progression was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.|Date of first imatinib dose to date of progression or death due to disease indication or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
1282837|NCT00237185|Secondary|Time to Onset of Response (Core + Extension)|Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.|Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
1282838|NCT00237185|Secondary|Time to Onset of Response (Core)|Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.|Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||weeks||95% Confidence Interval|Median
1282839|NCT00237185|Secondary|Time to Treatment Failure (Core + Extension)|Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.|Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
1282840|NCT00237185|Secondary|Time to Treatment Failure (Core)|Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis ate the time of their last tumor assessment.|Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||weeks||95% Confidence Interval|Median
1282841|NCT00237185|Secondary|Progression Free Survival (PFS) (Core + Extension)|Progression free survival was analyzed as a time to event for each participant. If a participant had no event, then the PFS was censored at the last tumor assessment.|Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.|||months||95% Confidence Interval|Median
1282842|NCT00237185|Secondary|Duration of Response (Core + Extension)|Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.|Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 months|Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.|||months||95% Confidence Interval|Median
1282843|NCT00237185|Secondary|Duration of Response (Core)|Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.|Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.|||weeks||95% Confidence Interval|Median
1282844|NCT00237185|Secondary|Overall Survival (Core + Extension)|Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.|Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.|||months||95% Confidence Interval|Median
1282845|NCT00237185|Secondary|Overall Survival (Core)|Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.|Date of first imatinib dose to the date of death during the core period, up to 36 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.|||months||95% Confidence Interval|Median
1282846|NCT00237185|Primary|Best Tumor Response (Core + Extension)|Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.|Month 156|Treatment population: the treatment population included all participants who had at least one dose of study medication.|||participants|||Number
1282847|NCT00237185|Primary|Best Tumor Response (Core)|Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.|Month 36|Treatment population: The treatment population included all randomized participants who received at least one dose of study medication.|||participants|||Number
1282848|NCT00237042|Secondary|Number of Participants With Pain-Related Activity Interference|Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference|12 months|Participants with 12 month follow up data. Intention to treat analysis.|||participants|||Number
1288789|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg|24-hour fed Leptin dose 0.1 mg/kg|1 DAY||||NG/ML||Standard Deviation|Mean
1282849|NCT00237042|Primary|Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)|Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.|12 months|Participants with 12 month follow up data. Intention to treat analysis.|||Units on a scale||Standard Deviation|Mean
1282850|NCT00237042|Secondary|Number of Participants With Pain-Related Activity Interference|Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference|6 Months|Participants with 6 month follow up data. Intention to treat analysis.|||participants|||Number
1282851|NCT00237042|Primary|Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)|Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.|6 months|Participants with 6 month follow up data. Intention to treat analysis.|||units on a scale||Standard Deviation|Mean
1282852|NCT00236977|Secondary|Mean Change From Baseline in Hemoglobin (g/dL) at Day 56||Change from Baseline at Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.|||g/dL||Standard Deviation|Mean
1282853|NCT00236977|Secondary|Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56||Change from Baseline at Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.|||percentage of change||Standard Deviation|Mean
1282854|NCT00236977|Secondary|Mean Change in Ferritin (ng/mL) From Baseline to Day 56||Change from Baseline at Day 56||||ng/mL||Standard Deviation|Mean
1282855|NCT00236977|Secondary|Highest Change From Baseline in Ferritin (ng/mL) up to Day 56||Change from Baseline up to Day 56|Only subjects who completed the study from the Intent to Treat (ITT) population.|||ng/mL||Standard Deviation|Mean
1282856|NCT00236977|Secondary|Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56||Change from Baseline up to Day 56|Only subjects who completed the study from the Intent to Treat (ITT) population.|||g/dL||Standard Deviation|Mean
1282857|NCT00236977|Secondary|Number of Subjects With a Clinical Response|Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)|Change from Baseline up to Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.|||participants|||Number
1282858|NCT00236977|Primary|Patients With an Increase in Hemoglobin >= 1gm/dL.||Change from Baseline up to Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.|||participants|||Number
1282859|NCT00236951|Primary|Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).|The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).|During Stage 2 (week 9 through week 21)|intention to treat (ITT)|||g/dL||Standard Deviation|Mean
1282860|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)|||percentage of change||Standard Deviation|Mean
1282861|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Ferritin up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)|||ng/mL||Standard Deviation|Mean
1282862|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)|||percentage of change||Standard Deviation|Mean
1282863|NCT00236938|Primary|Mean Change From Baseline to the Highest Hemoglobin up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT): All safety population subjects who received at least 1 dose of study medication or EPO and had at least 1 post-baseline efficacy measurement.|||g/dL||Standard Deviation|Mean
1282864|NCT00236899|Secondary|Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit|RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as all randomized participants.|||participants|||Number
1282865|NCT00236899|Secondary|Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle|RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as all randomized participants.|||participants|||Number
1282866|NCT00236899|Secondary|Number of Participants With Serious and Nonserious Adverse Events (AEs)|Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as the population of all randomized participants.|||participants|||Number
1282911|NCT00235755|Secondary|Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)|A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.|Week 1 through Week 16|Safety Population|||participants|||Number
1282867|NCT00236899|Secondary|Overall Response Rate(ORR) by Treatment Drug|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.|Baseline up to 49.84 months|All randomized participants treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population.|||percentage of responses|||Number
1282868|NCT00236899|Primary|Time to Progressive Disease (TTPD) by Treatment Drug|"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions."|Baseline up to 49.84 months|ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 33 (13.7%) participants were censored with 17 (13.68%) in the Docetaxel+Gemcitabine arm and 18 (13.71%) in the Paclitaxel+Gemcitabine arm.|||months||95% Confidence Interval|Median
1282869|NCT00236899|Secondary|Overall Response Rate (ORR) by Treatment Schedule|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.|Baseline up to 49.84 months|All randomized patients treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population.|||percentage of responses|||Number
1282870|NCT00236899|Secondary|Overall Survival (OS) by Treatment Drug|OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).|Baseline up to 51.64 months|ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 109 participants were censored with 55 (46.61%) in the Docetaxel+Gemcitabine arm and 54 (43.90%) in the Paclitaxel+Gemcitabine arm.|||months||95% Confidence Interval|Median
1282871|NCT00236899|Secondary|Overall Survival (OS) by Treatment Schedule|OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).|Baseline up to 51.64 months|Intention to treat (ITT) population defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 109 (45.2%) participants were censored with 53 (45.3%) in the Weekly arm and 56 (45.2%) participants in the 3 Weekly arm.|||months||95% Confidence Interval|Mean
1282872|NCT00236899|Primary|Time to Progressive Disease (TTPD) by Treatment Schedule|"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions."|Baseline up to 49.84 months|Intention to treat (ITT) population is defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 33 participants were censored with 16 (13.68%)in the Weekly arm and 17 (13.71%) participants in the 3 Weekly arm.|||months||95% Confidence Interval|Median
1282873|NCT00236197|Secondary|Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole||14 day randomized treatment period|||||||
1282874|NCT00236197|Secondary|Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole||14 day randomized treatment period|||||||
1282875|NCT00236197|Secondary|Summary of Percentage of Heartburn-Free Nighttimes||14-day randomized treatment period|||||||
1282876|NCT00236197|Secondary|Summary of Percentage of Heartburn-Free Daytimes|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
1282877|NCT00236197|Primary|Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population|The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.|First 24 hours|The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.|||Participants|||Number
1282878|NCT00236184|Primary|Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.|"Subject was considered complete relief if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity."|first 24 hours|The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.|||participants|||Number
1282879|NCT00236184|Secondary|Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
1282883|NCT00236080|Primary|Psychomotor Vigilance Task (PVT)|The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.|Endpoint (Visit 4) change from baseline (Visit 2)|Of the patients who completed the study, 1 patient in the PROVIGIL 200 mg/day treatment group and 1 patient in the Armodafinil 150 mg/day treatment group did not complete their PVT assessment.|||Milliseconds||Standard Deviation|Mean
1282884|NCT00236080|Primary|Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.|Endpoint (Visit 4) change from baseline (Visit 2)|"1 Placebo Patient did not have an MSLT but did complete the other Primary Measure (PVT) and other requirements. This patient was termed a Completer.~1 Patient in the Armodafinil 200 mg/day group had an MSLT performed but then discontinued the study drug before reaching the study endpoint and was termed a Non-Completer for the Study."|||Minutes||Standard Deviation|Mean
1282885|NCT00235989|Secondary|Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b|Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).|At End of Study Visit (week 234)|For the NAb analyses data were provided for 40 patients instead of 61 for week 234. Twenty-one patients had no data at this visit.The entries in the table are the number of patients with positive titer in the extension treatment cohorts for the three cutoff titer values. The analyses provide frequencies of positive titers.|||participants|||Number
1282886|NCT00235989|Primary|Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities|Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.|At End of Study Visit (week 234)|The statistical analysis was descriptive. For Liver Function Toxicity grading, the total number of patients for 250 micrograms (mcg) - 500 mcg group was 19 instead of 20 for all analyses.|||participants|||Number
1282887|NCT00235872|Secondary|Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit|Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||IU/mL||Standard Deviation|Mean
1282888|NCT00235872|Secondary|Presence of Rheumatoid Factor (RF)|The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||participants|||Number
1282889|NCT00235872|Secondary|Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit|Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||minutes||Standard Deviation|Mean
1282890|NCT00235872|Secondary|Presence of Morning Stiffness|The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||participants|||Number
1282891|NCT00235872|Secondary|Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit|Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mg/dL||Standard Deviation|Mean
1282892|NCT00235872|Secondary|Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit|Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mm on a scale||Standard Deviation|Mean
1282893|NCT00235872|Secondary|Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit|Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mm on unit scale||Standard Deviation|Mean
1282894|NCT00235872|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit|Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mm on unit scale||Standard Deviation|Mean
1282895|NCT00235872|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit|Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mm on a scale||Standard Deviation|Mean
1282896|NCT00235872|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit|Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||SJC||Standard Deviation|Mean
1282897|NCT00235872|Secondary|Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit|Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||TJC||Standard Deviation|Mean
1282898|NCT00235872|Primary|Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)|Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||participants|||Number
1282899|NCT00235833|Secondary|Number of Subjects With Morning Stiffness at Each Visit|The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|Subjects analyzed (as-observed) include only those who had morning stiffness at baseline.|||participants|||Number
1282900|NCT00235833|Secondary|Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)|Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts [TJC or SJC, respectively] and 20% improvement in 3 of the following 5 criteria: [1] Physician's global assessment (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein (CRP)|Every 6 weeks up to Week 24 and every 12 weeks thereafter||||Weeks||Standard Deviation|Mean
1282901|NCT00235833|Secondary|Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein [CRP; mg/dL], a component of the ACR criteria, by visit.|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||mg/dL||Standard Deviation|Mean
1282902|NCT00235833|Secondary|Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire [HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).], a component the of ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||units on a scale||Standard Deviation|Mean
1282903|NCT00235833|Secondary|Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||mm on scale||Standard Deviation|Mean
1282904|NCT00235833|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||mm on scale||Standard Deviation|Mean
1282905|NCT00235833|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||mm on scale||Standard Deviation|Mean
1282906|NCT00235833|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit|Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||SJC||Standard Deviation|Mean
1282907|NCT00235833|Secondary|Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||TJC||Standard Deviation|Mean
1282908|NCT00235833|Primary|Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)|Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts [TJC or SJC, respectively] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity [PGA], [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein [CRP]) at each visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|Analysis was based on observed data.|||participants|||Number
1282909|NCT00235755|Secondary|Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase|The number of participants with recorded weight gain of >=7% over their baseline weight was measured.|Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase|Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed.|||participants|||Number
1282910|NCT00235755|Secondary|Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase|Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline.|Baseline (Week -7 through 0), Weeks 8 and 16|Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed.|||milliliters||Full Range|Median
1282997|NCT00234286|Secondary|Individuals With a Palliative Care Consultation|Palliative Care Consultation based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1282912|NCT00235755|Secondary|Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)|Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.|Week 1 through Week 16|Safety Population|||participants|||Number
1282913|NCT00235755|Secondary|Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.|End of Baseline (Week 0), Weeks 4, 8, and 16|Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Only participants with QOLIE-31-P data were included in the analysis.|||scores on a scale||Standard Deviation|Mean
1282914|NCT00235755|Secondary|Patient Global Impression (PGI) Score at the End of the Maintenance Phase|PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 16/end of treatment phase|ITT EMEA Population. Only participants with post-baseline PGI scores were included in the analysis.|||scores on a scale||Standard Deviation|Mean
1282915|NCT00235755|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase|Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 16/end of treatment phase|ITT EMEA Population|||scores on a scale||Standard Deviation|Mean
1282916|NCT00235755|Secondary|Percentage of Seizure-free Days During the Maintenance Phase|A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%.|Week 5 through Week 16|ITT EMEA Population|||percentage of days||Full Range|Median
1282917|NCT00235755|Secondary|Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)|A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.|Week 1 through Week 16|ITT FDA Population. Only participants who had post-baseline seizure data were included in the analysis.|||percentage of days||Full Range|Median
1282918|NCT00235755|Secondary|Number of Participants Who Were Seizure-free During the Maintenance Phase|Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.|Week 5 through Week 16|ITT EMEA Population|||participants|||Number
1282919|NCT00235755|Secondary|Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)|Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.|Week 1 through Week 16|ITT FDA Population. Only participants with post-baseline seizure data were included in the analysis.|||participants|||Number
1282920|NCT00235755|Secondary|Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline|New seizure types included those seizures which were not reported by any participant at Baseline.|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population|||participants|||Number
1282921|NCT00235755|Secondary|Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase|Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population|||participants|||Number
1282922|NCT00235755|Secondary|Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population|||participants|||Number
1282923|NCT00235755|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category.|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population|||participants|||Number
1282998|NCT00234286|Secondary|Individuals With an Advance Directive|Presence of advance directive based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1282924|NCT00235755|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories|"Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the No reduction category."|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population|||participants|||Number
1282925|NCT00235755|Secondary|Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population|||Percent change in seizure frequency||Full Range|Median
1282926|NCT00235755|Secondary|Number of Participants Who Were Responders and Non-responders During the DB Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.|Week 1 through Week 16|ITT FDA Population|||participants|||Number
1282927|NCT00235755|Primary|Number of Participants Classified as Responders and Non-responders During the Maintenance Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.|Week 5 through Week 16|ITT European Medicines Evaluation Agency (EMEA) Population: all randomized participants who had received at least 1 dose of study drug in the Maintenance Phase and had at least 1 seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase.|||participants|||Number
1282928|NCT00235755|Primary|Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)|28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)|Intent-to-Treat Food and Drug Administration (ITT FDA) Population: all randomized participants (P) who received at least 1 dose of study drug. Only participants with post-BL seizure data are included in this analysis.|||percent change in seizure frequency||Full Range|Median
1282929|NCT00235716|Other Pre-specified|All-cause Mortality|Survival analysis of death from any cause.|up to 4 years|Intention-to-treat analysis that includes all randomized participants.|||participants|||Number
1282930|NCT00235716|Primary|Caregiver Activity Survey Change From Baseline|The Caregiver Activity Survey (CAS) was developed to measure the time caregivers spend aiding Alzheimer patients with their day-to-day activities. The CAS consists of six items that ask for an estimate in hours and minutes of the time that the caregiver spent during the previous 24 hours performing these particular activities. The six CAS items are as follows: 1) communication with the person, 2) using transportation, 3) dressing, 4) eating, 5) looking after one's appearance, and 6) supervising the person. The more caregiving hours the worse the patient's functioning level. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||hours per day||Standard Error|Least Squares Mean
1282931|NCT00235716|Primary|Neuropsychiatric Inventory Change From Baseline|The Neuropsychiatric Inventory (NPI) assesses psychological and behavioral problems in patients with dementia. For each of twelve domains, there are four scores: frequency, severity, total frequency x severity, and caregiver distress. The frequency x severity total scores from each domain are summed for an overall total score that ranges from 0 to 144. The total caregiver distress scores are also summed for an overall total caregiver distress score that ranges from 0 to 60. The secondary endpoint for the trial will be the overall frequency times severity total score. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||units on a scale||Standard Error|Least Squares Mean
1282932|NCT00235716|Primary|Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline|The Alzheimer's Disease Assessment Scale (ADAS) is a 21-item scale designed to assess the severity of cognitive and non-cognitive behavioral impairments in patients with Alzheimer's disease. The cognitive portion of the scale (ADAS-cog) consists of 11 items to assess memory, language, and praxis functions. The ADAS-cog total score ranges from 0 (no errors) to 70 (severe cognitive impairment). Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||units on a scale||Standard Error|Least Squares Mean
1282933|NCT00235716|Primary|Mini-Mental State Examination Change From Baseline|The Mini-Mental State Examination (MMSE) briefly and objectively assess cognitive status in psychiatric patients with cognitive impairment. The MMSE questions are grouped into seven categories, each representing a different cognitive domain. The MMSE yields a total score that ranges from 0 for a patient who gives no correct response to a score of 30 for a patient who makes no errors. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||units on a scale||Standard Error|Least Squares Mean
1282999|NCT00234286|Secondary|Individuals With Pastoral Care Visit|Pastoral Care Visit based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1282934|NCT00235716|Secondary|Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)|The Dependence Scale assesses the level of assistance needed by patients with Alzheimer's disease for activities of daily living. The scale yields six levels of dependence: no assistance required (Level 0); requires occasional reminders (Level 1); requires frequent reminders and/or help with household chores (Level 2); needs daily supervision (Level 3); needs to be dressed, toileted or fed (Level 4); needs to be transferred, diapered or tube fed (Level 5).|Every 6 months to a maximum of 4 years|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||participants|||Number
1282935|NCT00235716|Primary|Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline|The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||units on a scale||Standard Error|Least Squares Mean
1282936|NCT00235573|Secondary|Total Transcobalamin Measured at Intervals From Baseline to 48 Hours.||Baseline through 48 hours at intervals of 0, 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6, 7, 8, 9, 10, 11, 11.5, 12.5, 24, 48|||||||
1282937|NCT00235573|Primary|Change in Holo-transcobalamin|Holo-TC is a vitamin B12 carrier protein. Only vitamin B12 bound to holo-TC can be taken up by cells. Changes in holo-TC after an oral dose of vitamin B12 may provide a clinical test to assess vitamin B12 absorption. The change in holo-transcobalamin (holo-TC) from baseline was measured at timed intervals in response to supplemental vitamin B12 and compared to baseline. The purpose was to ascertain the time point at which holo-TC reaches the maximum concentration in the blood following a dose of vitamin B12 in subjects without defects in vitamin B12 absorption.|Holo-transcobalamin measured at 24 hours after baseline|The number of participants for analysis was per protocol.|||pmol/L||Standard Deviation|Mean
1282938|NCT00235456|Secondary|Hospital Length of Stay|The number of days patient stayed in the hospital after surgery.|time to hospital discharge after surgery||||days||Standard Deviation|Mean
1282939|NCT00235456|Secondary|Staples Removed|Time to staples removed, measured in days|time to event after surgery||||days||Standard Deviation|Mean
1282940|NCT00235456|Secondary|First Solid Food Intake|Time to restarting feeding after surgery, measured in days.|time to event after surgery||||days||Standard Deviation|Mean
1282941|NCT00235456|Secondary|Return to Ambulation|time to return to ambulation after surgery, measured in days|time to event after surgery||||days||Standard Deviation|Mean
1282942|NCT00235456|Secondary|Return of Bowel Function|Time to return of bowel function, measured in days.|time to event after surgery to discharge from hospital||||days||Standard Deviation|Mean
1282943|NCT00235456|Primary|Incisional Surgical Wound Infection|Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.|0 to 14 days after surgery||||participants|||Number
1282944|NCT00235443|Secondary|Change From Baseline in Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS)|Change from Baseline in quality of life using the SF-36 Health Survey – Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282945|NCT00235443|Secondary|Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)|Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282946|NCT00235443|Secondary|Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)|Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.|Baseline to end of entire treatment phase visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282947|NCT00235443|Secondary|Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)|Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.|Baseline to end of entire treatment phase visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282948|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282949|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282950|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable (intolerable)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282951|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable (like poison oak)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282952|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable (raw skin)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282953|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable (freezing)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282954|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282955|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable (on fire)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282956|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable (like a knife)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282957|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity.|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282958|NCT00235443|Secondary|Patient’s Global Impression of Change (PGIC) From Baseline in Pain.|Patient’s Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Participants|||Number
1282959|NCT00235443|Secondary|Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).|Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.|Baseline to end of entire treatment phase (maximum study period of 2.8 years).|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282960|NCT00235443|Secondary|Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).|Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.|Baseline to end of entire treatment phase (maximum study period of 2.8 years).|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
1282961|NCT00235443|Primary|Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.|Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).|Throughout the study up to a maximum study period of 2.8 years|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Participants|||Number
1282962|NCT00235391|Secondary|The Change in Serum Ferritin Values From Baseline Through Completion of the Study|The number of participants with Improvement, No Change or Worsening in Serum ferritin category levels at the end of the study compared to baseline. Serum ferritin levels in µg/L were divided into to 6 categories: (<1000), (1000-<2500), (2500-<4000), (4000-<5500), (5500-<7000) and (>=7000). Improvement was defined as a shift to a lower category at the end of study compared to the category at baseline. Worsening was defined as a shift to a higher category at the end of the study compared to the category at baseline. No change was no change in category at end of study from baseline.|Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)|Safety population defined as all participants who received at least one dose of study drug. This analysis did not include participants with unknown status at baseline and/or at the end of the study.|||Participants|||Number
1282963|NCT00235391|Primary|Safety Profile of Deferasirox Based Upon Drug Administration and Reporting of Serious Adverse Events|Safety as assessed by the number of participants with death, serious adverse events (SAE), and/or Adverse Events (AEs) leading to study drug interruption or discontinuation. Note: only treatment emergent AEs are summarized.|Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)|The safety population, comprising all participants who received at least one dose of deferasirox during the study, was used in the analyses.|||Participants|||Number
1282964|NCT00235326|Primary|Number of Participants With Post Infectious Irritable Bowel Syndrome||8 years||||participants|||Number
1282965|NCT00234884|Primary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||units on a scale||Standard Deviation|Mean
1282966|NCT00234884|Primary|American College of Rheumatology 70% (ACR70) Response Rate|ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||participants|||Number
1282967|NCT00234884|Primary|American College of Rheumatology 50% (ACR50) Response Rate|ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||percentage of participants|||Number
1282968|NCT00234884|Primary|American College of Rheumatology 20% (ACR20) Response Rate|ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||percentage of participants|||Number
1282969|NCT00234884|Primary|Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)|DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||units on a scale||Standard Deviation|Mean
1282970|NCT00234832|Secondary|Risk of Experiencing Cardiovascular Death Included in the POE|For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
1282971|NCT00234832|Secondary|Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE|For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
1282972|NCT00234832|Secondary|Risk of Experiencing a Nonfatal Stroke Included in the POE|For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
1282973|NCT00234832|Secondary|Risk of Experiencing a Nonfatal MI Included in the POE|For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
1282974|NCT00234832|Secondary|Risk of Experiencing a POE or a Revascularization Procedure|This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
1282975|NCT00234832|Secondary|Risk of Death From Any Cause (All-cause Mortality)|For each subject who died, the time to death was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
1282976|NCT00234832|Primary|Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)|For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.|From randomization up to 6 years|Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.|||Participants|||Number
1282977|NCT00234533|Secondary|Extent of Exposure to NutropinAq Throughout the Study|The extent of treatment exposure throughout the study is presented as the mean number of daily injections performed.|Up to Week 24|The Safety Population consisted of all patients who received at least one injection of treatment.|||days||Standard Deviation|Mean
1283000|NCT00234286|Secondary|Sublingual Administration|Sublingual administration of medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1282978|NCT00234533|Secondary|Posology of NutropinAq at Baseline (Visit 1) Summarised as Mean Dose|It was intended that the posology (mg/kg/day) of NutropinAq would remain constant throughout the study. The mean posology adopted at Visit 1 is presented.|Visit 1 (Baseline)|The Safety Population consisted of all patients who received at least one injection of treatment.|||mg/kg/day||Standard Deviation|Mean
1282979|NCT00234533|Secondary|Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen|"The acceptability was evaluated by a questionnaire at Month 5. The users (parents and/or child) of NutropinAq pen and compliance aid booklet were asked to describe and rate the pen, cartridge, compliance aid booklet and their ease of use.~The percentage of patients responding to each category for the assessment of the overall handling of the NutropinAq pen are presented. The categories are: Very easy, Easy, Moderately difficult, Difficult, Very difficult and Missing."|At Month 5|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||Percentage of patients|||Number
1282980|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity SDS|"The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Annualised GV SDS = (annualised GV – reference mean annualised GV (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth velocity, therefore, a favorable outcome.~Change from baseline in the annualised growth velocity SDS at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||SD Score||Standard Deviation|Mean
1282981|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity|"The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24).~Change from baseline in the measured annualised growth velocity at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||cm/year||Standard Deviation|Mean
1282982|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Calculated Weight SDS|"The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Weight SDS = (weight – reference mean weight (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in weight, therefore, a favorable outcome.~Change from baseline in the calculated weight SDS at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||SD Score||Standard Deviation|Mean
1282983|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Weight|"The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24).~Change from baseline in measured weight at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||kg||Standard Deviation|Mean
1282984|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Calculated Height SDS|"The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Height SDS = (height – reference mean height (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth, therefore, a favorable outcome.~Change from baseline in the calculated height SDS at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||SD Score||Standard Deviation|Mean
1282985|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Height|"The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24).~Change from baseline in measured height at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||cm||Standard Deviation|Mean
1282986|NCT00234533|Secondary|Change From Baseline at Week 12 and Week 24 in Insulin-Like Growth Factor Binding Protein 3 (IGFBP3) Measurements|"The LWPES recommends that treatment for any indication with recombinant GH therapy in children be accompanied by regular monitoring of IGF-I and IGFBP3 concentrations. IGFBP3 binds circulating IGF-I and serum samples were taken at Visit 1 (Week 0), Visit 2 (Week 12) and Visit 3 (Week 24) in order to measure IGFBP3.~Change from baseline (Visit 1) at Visits 2 and 3 in IGFBP3 is presented."|Baseline to Week 12 and Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Evaluable subjects with data available at each timepoint are presented.|||ng/mL||Standard Deviation|Mean
1283001|NCT00234286|Secondary|Individuals Who Received Scopolamine|Administration of scopolamine (for death rattle) based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
1282987|NCT00234533|Secondary|Change From Baseline at Week 24 in the IGF-I Levels as Measured by Capillary Blood Spot Method and Serum IGF-I Assay|"3 simultaneous IGF-I measurements were taken at Weeks 0 (baseline), 12 and 24 by serum and capillary assay to determine the precision profile of the capillary blood spot method versus the serum IGF-I assay.~Change from baseline at Week 24 in the IGF-I measurements by capillary blood spot method and serum assay are presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Evaluable subjects with data available at Week 24 are presented.|||ng/mL||Standard Deviation|Mean
1282988|NCT00234533|Secondary|Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition|"A multivariate linear regression analysis of factors on WCV using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of the time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition on the IGF-I value were assessed.~Parameter estimates from the statistical model are presented as least squares means for the categories of time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition (GHD and TS)."|Up to Week 24|The Per Protocol Population consisted of all patients in the ITT Population for whom no major protocol violations/deviations occurred. Only evaluable subjects within each of the individual subgroups are presented for each category.|||Regression coefficient||Standard Error|Least Squares Mean
1282989|NCT00234533|Secondary|Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location|"A multivariate linear regression analysis of factors on within-subject coefficient of variation (WCV) using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of disease condition and country clusters on the IGF-I value were assessed.~Country clusters: cluster 1: France; cluster 2: Spain, Greece, Romania and Italy; cluster 3: UK, Belgium, Czech Republic, Denmark, Germany, Slovakia, Austria and Finland ; cluster 4: Russia ; cluster 5: Ukraine.~Parameter estimates from the statistical model presented as least squares means for categories of disease condition (GHD and TS) and location (Clusters 1, 2, 3, 4 and 5) are presented."|Up to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Only evaluable subjects within each of the individual subgroups are presented for each category. As there was only 1 patient with CRI, no analysis was performed for this disease condition.|||Regression coefficient||Standard Error|Least Squares Mean
1282990|NCT00234533|Secondary|Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status|The influence of sex and prepubertal status on the IGF-I value as measured using the capillary blood spot method was analysed. Parameter estimates from the statistical model are presented as least squares means for the categories of sex (male and female) and prepubertal status (pubertal and prepubertal). The values reported represent average IGF-I levels as determined from the 6 measurements taken (i.e. morning and evening samples at Weeks 21, 22 and 23).|At Weeks 21, 22 and 23|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||ng/mL||95% Confidence Interval|Least Squares Mean
1282991|NCT00234533|Secondary|Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)|The influence of daily and weekly timing on the IGF-I value as measured using the capillary blood spot method was analysed. A 3-way analyses of variance (ANOVA) was performed with patient, day and daily timing as factors after appropriate transformation to obtain normally distributed parameters. The interaction day*time was tested and kept in the model only if p-value<0.1. Parameter estimates from the statistical model are presented as least squares means for the categories of daily timing (Morning and Evening) and weekly timing (Week 21, Week 22 and Week 23). The values reported for Week 21, 22, and 23 represent the average IGF-I levels from the morning and evening samples at each week. The values reported for Evening represent the Evening IGF-I levels averaged across Weeks 21, 22, and 23, and similarly for the Morning values.|At Weeks 21, 22 and 23|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||ng/mL||95% Confidence Interval|Least Squares Mean
1282992|NCT00234533|Primary|Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples|"Fingertip capillary blood was collected using filter paper cards for the assay of capillary blood spot IGF-I in line with the monitoring recommendations of the Lawson Wilkins Paediatric Endocrine Society (LWPES) for treatment with recombinant GH therapy in children.~Capillary IGF-I assays were performed by the patient at home one day per week during Weeks 21, 22 and 23 only (same week day). The samples were scheduled in the evening prior to the injection of NutropinAq and between 7:00 and 9:00 the following morning. An extended window from 6:00 to 12:00 was allowed for defining protocol deviations.~The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients was assessed. IGF-I measurements for the morning and evening sampling are presented."|At Weeks 21, 22 and 23|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Only evaluable subjects with an assessment at the specified timepoint were included in each individual analysis.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
1282993|NCT00234494|Secondary|Duration of Response for Responding Patients|To estimate duration of response for responding patients.|36 months|Data for this secondary outcome measure was not collected or analyzed.||||||
1282994|NCT00234494|Secondary|Estimate Response Rates|To estimate rate of partial response (PR), complete response (CR) and overall response (PR plus CR).|36 months||||percentage of participants|||Number
1282995|NCT00234494|Secondary|Overall Survival Time|To estimate overall survival time in months.|36 months||||months||95% Confidence Interval|Median
1282996|NCT00234494|Primary|Progression Free Survival|- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.|36 months||||months||95% Confidence Interval|Median
1283013|NCT00234104|Primary|Body Weight|The body weight change from baseline following final trial drug administration|Baseline, at the time of final trial drug administration|1 Subject of Placebo arm who experienced a serious adverse event was excluded from efficacy analysis set because the emergency code was broken.|||Kg||Standard Deviation|Mean
1283014|NCT00234078|Post-Hoc|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Week 12|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. The CFB in the LGCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett’s t-test.|Baseline, 12weeks|From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis|||scores on a scale||Standard Deviation|Mean
1283015|NCT00234078|Post-Hoc|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Week 12|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The CFB in the FCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett’s t-test|Baseline, 12week|From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis|||scores on a scale||Standard Deviation|Mean
1283016|NCT00234078|Primary|Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)|POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|Baseline, 12 weeks||||scores on a scale||Standard Deviation|Mean
1283017|NCT00234078|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|baseline, 12 weeks||||scores on a scale||Standard Deviation|Mean
1283018|NCT00234065|Other Pre-specified|Number of Patients With First Occurrence of Haemorrhagic Event|The endpoint in this measure is a composite endpoint of the first occurrence of cerebral haemorrhage, subarachnoid haemorrhage or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])||||participants|||Number
1283019|NCT00234065|Secondary|Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])||||participants|||Number
1283020|NCT00234065|Secondary|Number of Deaths From Any Cause|Number of deaths from any cause. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])||||participants|||Number
1283021|NCT00234065|Secondary|Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|||participants|||Number
1283022|NCT00234065|Secondary|Number of Patients With First Recurrence of Cerebral Infarction||From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])||||participants|||Number
1283023|NCT00234065|Primary|Numbers of Patients With First Occurence of Stroke|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])|Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|||participants|||Number
1283024|NCT00234039|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1283025|NCT00234039|Secondary|Recurrence-free Survival (RFS)|Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.|1 year|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1283026|NCT00234039|Primary|Complete Response Rate at the End of Induction|Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy|Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1283027|NCT00234039|Secondary|Overall Survival (OS)|Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.|1 year|All eligible patients who started treatment were included in the analysis|||percentage of participants|||Number
1283028|NCT00233987|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1283029|NCT00233987|Secondary|Overall Survival|Measured from date of registration to date of death due to any cause or last contact|At day 60, then every 6 months for 2 years, then annually for a total of 7 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1283030|NCT00233987|Secondary|Response Rate|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|At day 60, then every 6 months for 2 years|All eligible patients who started treatment were included in the analysis. Five patients with no evidence of disease at baseline were excluded.|||participants|||Number
1283031|NCT00233987|Primary|2-year Progression-free Survival|Measured from date of randomization to date of first observation of progressive disease, or death due to any cause|At day 60, then every 6 months for 2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1283032|NCT00233948|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 3 cycles of treatment, up to 2 years.|Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.|||participants|||Number
1283033|NCT00233948|Primary|Maximum Tolerated Dose (MTD) (Phase I)|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. If PK analysis of 3 patients treated at 4250 mg bid and 3 patients at 3000 mg bid confirms that the first dose area under the curve and Cmax of nelfinavir does not increase appreciably at doses greater than 1875 mg BID then 3000 mg BID will be deemed the MTD.|4 weeks from start of treatment, up to 2 years|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg|||Number
1283034|NCT00233948|Primary|Dose Limiting Toxicity (DLT) (Phase I)|DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.|||participants with DLTs|||Number
1283035|NCT00233519|Primary|The Number of Study Participants Who Safely Tolerated Somatokine|Safety and tolerability was measured via interval laboratory studies,electrocardiograms, echocardiograms, ultrasounds of the abdomen and pelvis, dual energy x-ray absorptiometry (DEXA) studies, chest and neck x-rays, and serial physical examinations. The participants had six inpatient evaluations at the University of Rochester General Clinical Research Center (Weeks 0, 8, 16, 24, 28, and 40) and nine outpatient evaluations. Patients also completed side effects diaries to record any adverse events in the interval time between inpatient and outpatient evaluations.|24 weeks||||participants|||Number
1283036|NCT00233454|Secondary|Overall Survival (OS)|Overall survival was assessed as the median duration of survival at the time of data cut-off, and reported with 95% confidence interval.|40 months||||months||95% Confidence Interval|Median
1283037|NCT00233454|Secondary|Overall Survival (OS)|Overall survival will be assessed after 12 cycles of treatment, with each cycle being 28 days (4 weeks) in length. 12 cycles of treatment is considered to be about 11 months.|11 months||||participants|||Number
1283075|NCT00233064|Primary|Number and Percentage of Participants With Immune Reactivity|Presence of anti-palivizumab antibodies|Day 240-300 follow up|Participants who received at least 2 doses of study drug and had at least 1 blood sample collected (at baseline or Study Day 240-300) were included in the analysis. This included 206 subjects in Arm 1 and 200 subjects in Arm 2. Of these subjects, 191 (Arm 1) and 188 (Arm 2) had adequate blood samples for analysis. This analysis was per protocol.|||Participants|||Number
1283550|NCT00224055|Primary|Change in Hemoglobin (Hgb)|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation|||g/dL||Standard Deviation|Mean
1283038|NCT00233454|Primary|Subjects With Clinical Response [Partial Response (PR) + Complete Response (CR)]|"Clinical Response [PR + CR] will be assessed after 2 cycles of treatment, with each cycle being 28 days (4 weeks) in length.~Except as otherwise noted, the minimum criteria for PR is improvement by at least 50% from the baseline value towards the indicated value for one or more of the criteria below:~BONE MARROW & BLOOD~ANC <1000/uL~Hb <10 g/dL~Platelets >100,000/uL LIVER~If hepatomegaly with ascites, decrease in frequency of paracenteses by 50%~Elevated enzyme levels > upper limit of normal (ULN)~Hypoalbuminemia < ULN~Portal hypertension > ULN SPLEEN~If palpable splenomegaly with hypersplenism/thrombocytopenia, hypersplenism markers improved GI TRACT~If malabsorption with hypoalbuminemia and/or weight loss, albumin improved BONES~If huge osteolyses or/and severe osteoporosis with pathologic fractures, partial resolution of osteolyses~Subjects with PR or greater continue, those without response discontinue."|2 months||||participants|||Number
1283039|NCT00233402|Secondary|Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.||Day 0||||percentage of participants||95% Confidence Interval|Number
1283040|NCT00233402|Secondary|Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.|"The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).~The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately."|Day 0||||Percetange of lesion||95% Confidence Interval|Number
1283041|NCT00233402|Primary|Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.||9 months|ITT population|||percentage of participants|||Number
1283042|NCT00233402|Primary|Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light||Day 0|Analysis was based on ITT population|||percentage of participants||95% Confidence Interval|Number
1283043|NCT00233324|Secondary|Cerebral Palsy||18-22 months|||||||
1283044|NCT00233324|Secondary|Necrotizing Enterocolitis (NEC)||120 days|||||||
1283045|NCT00233324|Secondary|Received Postnatal Steroids||120 days|||||||
1283046|NCT00233324|Secondary|Blindness in at Least One Eye||18-22 months|||||||
1283047|NCT00233324|Secondary|Pulse Oximetry Values > 90%||120 days|||||||
1283048|NCT00233324|Secondary|Duration of Oxygen Supplementation||120 days|||||||
1283049|NCT00233324|Secondary|Endotracheal Intubation||Before 10 minutes of age|||||||
1283050|NCT00233324|Secondary|Threshold ROP Requiring Surgery||120 days|||||||
1283051|NCT00233324|Secondary|Periventricular Leukomalacia (PVL)||120 days|||||||
1283052|NCT00233324|Secondary|Severe Intraventricular Hemorrhage (IVH)||120 days|||||||
1283053|NCT00233324|Secondary|Death||18-22 months|||||||
1283054|NCT00233324|Secondary|Bronchopulmonary Disease (Using the Physiologic Definition of BPD)||36 weeks|||||||
1283055|NCT00233324|Secondary|Incidence of Air Leaks||120 days|||||||
1283056|NCT00233324|Secondary|Received Surfactant Treatment||120 days|||||||
1283057|NCT00233324|Secondary|Survival Without Ventilation||By day 7|||||||
1283058|NCT00233324|Secondary|Duration of Mechanical Ventilation||During entire NICU stay|||||||
1283059|NCT00233324|Secondary|Death or Neurodevelopmental Impairment||18-22 months||||participants|||Number
1283060|NCT00233324|Other Pre-specified|Apgar Score||5 minutes|||||||
1283061|NCT00233324|Primary|Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)||55 weeks|49 infants in the lower oxygen saturation group and 46 infants in the higher oxygen saturation group that had unknown retinopathy of prematurity outcome|||participants|||Number
1283062|NCT00233324|Primary|Survival Without Bronchopulmonary Dysplasia (BPD)||36 weeks||||Participants|||Number
1283063|NCT00233103|Primary|Depression at End of Treatment|"Self-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention.~The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression."|end of treatment, average of 10 weeks||||units on a scale||Standard Deviation|Mean
1283064|NCT00233103|Secondary|Life-3|Life-3 is a single-item Quality of life (QOL) measure that uses a 7-point Likert-type scale to assess satisfaction with life during the past month. It is typically administered twice during an evaluation, and the mean of the 2 obtained scores is used. Higher scores on this measure indicate higher levels of subjective QOL. Range from 1 to 7.|Immediately post-intervention at 10 weeks||||units on a scale||Standard Deviation|Mean
1283065|NCT00233103|Secondary|BAI|The Beck Anxiety Inventory (BAI) is a 21-item self-report measure that assesses subjective, somatic, or panic-related symptoms associated with anxiety rated on a scale from 0 (not at all) to 3(severely). Total score: 0-7 = minimal level of anxiety, 8-15 = mild anxiety, 16-25 = moderate anxiety, and 26-63 = severe depression|Immediately post-intervention||||units on a scale||Standard Deviation|Mean
1283066|NCT00233103|Primary|Depression at Baseline|"The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.~Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline."|baseline||||units on a scale||Standard Deviation|Mean
1283067|NCT00233090|Secondary|Quality of Life|quality of life|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
1283068|NCT00233090|Secondary|Participation|participation|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
1283076|NCT00232739|Secondary|Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge|Procedure success defined as achievement of a final diameter stenosis of less than 50 percent (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay|From post-procedure to hospital discharge|Number of participants without missing procedure success data|||Percentage of participants||95% Confidence Interval|Mean
1283077|NCT00232739|Secondary|Percentage of Participants Who Achieved Device Success at Post-procedure|Device success was defined as achievement of a final residual diameter stenosis of less than 50 percent as measured by QCA, using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used|At post-procedure|All participants|||Percentage of participants||95% Confidence Interval|Mean
1283078|NCT00232739|Secondary|Percentage of Participants Who Achieved Lesion Success at Post-procedure|Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method|At post-procedure|Number of Participants without missing lesion success data|||Percentage of participants||95% Confidence Interval|Mean
1283079|NCT00232739|Secondary|Average Stent Obstruction Volume at 6 Months Post-procedure||From post-procedure to 6 months|The number of participants with Stent Obstruction Volume data at 6 months post-procedure|||mm3||Standard Deviation|Mean
1283080|NCT00232739|Secondary|Average Lumen Volume (mm3) at 6 Months Post-procedure||From post-procedure to 6 months|The number of participants who had Lumen Volume data at 6 months post-procedure|||mm3||Standard Deviation|Mean
1283081|NCT00232739|Secondary|Average Stent Obstruction Volume at Post-procedure|Stent obstruction Volume equals 100 * [1-(lumen volume/baseline stent volume)]; usually this is equal to zero at baseline, since the stent is freshly implanted and no obstruction is expected|At post-procedure|Number of participants who had Stent Obstruction Volume data at post-procedure|||mm3||Standard Deviation|Mean
1283082|NCT00232739|Secondary|Average Lumen Volume (mm3) at Post-procedure||At Post-procedure|The number of participants who had lumen volume data at post-procedure|||mm3||Standard Deviation|Mean
1283083|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure|TVF was defined as any Target vessel revascularization, Q wave or non-Q wave MI, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.|From post-procedure to 6 months and 9 months follow-up|The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.|||Percentage of participants||95% Confidence Interval|Mean
1283084|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.|TVR was defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations were those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis being greater than or equal to 50 percent measured by QCA.|From post-procedure to 6 months and 9 months follow-up|The number of participants who had sufficient 9 months post-procedure follow-up or had the event prior to 9 months.|||Percentage of participants||95% Confidence Interval|Mean
1283085|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.|TLR was defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.|From post-procedure to 6 months and 9 months|The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.|||Percentage of participants||95% Confidence Interval|Mean
1283086|NCT00232739|Secondary|Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.||From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.|||mm||Standard Deviation|Mean
1283087|NCT00232739|Secondary|Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.|In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.|From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.|||Percentage of participants||95% Confidence Interval|Mean
1283088|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up|The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure to 4 years|The number of participants who had four years post-procedure follow up or who had at least one event prior to the end of follow-up.|||Percentage of participants||95% Confidence Interval|Mean
1283089|NCT00232739|Primary|Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure|In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.|From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis (BAR) results.|||Percentage of participants||95% Confidence Interval|Mean
1283090|NCT00232596|Secondary|Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase|The number of participants with recorded weight gain of >=7% over their baseline weight was measured.|Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase|Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed.|||participants|||Number
1283113|NCT00232583|Secondary|Quality of Life Survey (QoL) - Lifestyle Flexibility|Lifestyle flexibility was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.|72 months||||score on a scale||Standard Deviation|Mean
1283091|NCT00232596|Secondary|Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase|Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 18 minus the value at Baseline.|Baseline (Week -7 through Week 0), Weeks 10 and 18|Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed.|||milliliters||Full Range|Median
1283092|NCT00232596|Secondary|Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)|A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.|Week 1 through Week 24|Safety Population|||participants|||Number
1283093|NCT00232596|Secondary|Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)|Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.|Week 1 through Week 24|Safety Population|||participants|||Number
1283094|NCT00232596|Secondary|Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.|End of Baseline (Week 0), Weeks 6, 10, and 18|Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Participants who were cognitively impaired and could not complete the QOLIE-31-P assessment were not analyzed. The number of participants analyzed differs by week because not all participants completed the questionnaire at the indicated weeks.|||scores on a scale||Standard Deviation|Mean
1283095|NCT00232596|Secondary|Patient Global Impression (PGI) Score at the End of the Maintenance Phase|PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 18/end of treatment phase|ITT Population for EMEA review. Only participants who had a PGI score were analyzed.|||scores on a scale||Standard Deviation|Mean
1283096|NCT00232596|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase|Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 18/end of treatment phase|ITT Population for EMEA review. Only participants who had CGI-I scores were analyzed.|||scores on a scale||Standard Deviation|Mean
1283097|NCT00232596|Secondary|Percentage of Seizure-free Days During the Maintenance Phase|A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in the DB period x 100%.|Week 7 through Week 18|ITT Population for EMEA review|||percentage of days||Full Range|Median
1283098|NCT00232596|Secondary|Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)|A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.|Week 1 through Week 18|ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis.|||percentage of days||Full Range|Median
1283099|NCT00232596|Secondary|Number of Participants Who Were Seizure-free During the Maintenance Phase|Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.|Week 7 through Week 18|ITT Population for EMEA review|||participants|||Number
1283100|NCT00232596|Secondary|Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)|Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.|Week 1 through Week 18|ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis.|||participants|||Number
1283101|NCT00232596|Secondary|Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline|New seizure types included those seizures which were not reported by any participant at Baseline.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review|||participants|||Number
1283178|NCT00232141|Secondary|Categorized Patient Global Impression of Change (PGIC)|The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).|Baseline, Week 14|ITT Population|||participants|||Number
1283102|NCT00232596|Secondary|Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase|Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review.|||participants|||Number
1283103|NCT00232596|Secondary|Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review|||participants|||Number
1283104|NCT00232596|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the 0-10% increase category.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review|||participants|||Number
1283105|NCT00232596|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data were included in the “No reduction” category.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review|||participants|||Number
1283106|NCT00232596|Secondary|Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review|||percent change in seizure frequency||Full Range|Median
1283107|NCT00232596|Secondary|Number of Participants Who Were Responders and Non-responders in the DB Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.|Week 1 through Week 18|ITT Population for FDA review|||participants|||Number
1283108|NCT00232596|Primary|Number of Participants Who Were Responders and Non-responders in the Maintenance Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.|Week 7 through Week 18|Intent-to-Treat (ITT) Population for European Medicines Agency (EMEA) review: all randomized participants who received at least one dose of study drug in the Maintenance Phase and had at least one seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase|||participants|||Number
1283109|NCT00232596|Primary|Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)|28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 1 through Week 18|Intent-to-Treat (ITT) Population for Food and Drug Administration (FDA) review: all randomized participants (par.) who received at least one dose of the study drug. Only par. with baseline and post-baseline measures were analyzed. Two par. in each treatment arm did not have post-baseline measures and were thus not included in this analysis.|||percent change in seizure frequency||Full Range|Median
1283110|NCT00232583|Secondary|Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment|Willingness to continue insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.|72 months|"Data were not collected from participants in the Metfomin, Pioglitazone & Glyburide Arm/Group since patients did not receive insulin."|||score on a scale||Standard Deviation|Mean
1283111|NCT00232583|Secondary|Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment|Satisfaction with insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.|72 months|"Data were not collected from participants in the Metfomin, Pioglitazone & Glyburide Arm/Group since patients did not receive insulin."|||score on a scale||Standard Deviation|Mean
1283112|NCT00232583|Secondary|Quality of Life Survey (QoL) - Social Stigma|Social stigma was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1- strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.|72 months||||score on a scale||Standard Deviation|Mean
1283114|NCT00232583|Secondary|Quality of Life Survey (QoL) - Glycemia Control Perception|Glycemia control perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1–7, where 1 - extremely controlled and 7 - not at all controlled.|72 months||||score on a scale||Standard Deviation|Mean
1283115|NCT00232583|Secondary|Quality of Life Survey (QoL) - Hypoglycemia Fear|Hypoglycemia fear was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry|72 months||||score on a scale||Standard Deviation|Mean
1283116|NCT00232583|Secondary|Quality of Life Survey (QoL) - Social or Vocational Worry|Social or vocational worry was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0–5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.|72 months||||score on a scale||Standard Deviation|Mean
1283117|NCT00232583|Secondary|Quality of Life Survey (QoL) - Treatment Impact|Treatment impact was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.|72 months||||score on a sale||Standard Deviation|Mean
1283118|NCT00232583|Secondary|Quality of Life Survey (QoL) - Treatment Satisfaction|Treatment satisfaction was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.|72 months||||score on a scale||Standard Deviation|Mean
1283119|NCT00232583|Secondary|Quality of Life Survey (QoL) - Current Health Perception|Current health perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.|72 months||||score on a scale||Standard Deviation|Mean
1283120|NCT00232583|Secondary|Inflammatory Markers - PAI-1|Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1)|72 months||||IU/L||Standard Deviation|Mean
1283121|NCT00232583|Secondary|Inflammatory Markers -Fibrinogen|Inflammatory markers - Fibrinogen|72 months||||mg/dL||Standard Deviation|Mean
1283122|NCT00232583|Secondary|Inflammatory Markers - hsCRP|Inflammatory markers - hsCRP (C reactive protein)|72 months||||mg/L||Standard Deviation|Mean
1283123|NCT00232583|Secondary|Weight|Body Weight|72 months||||kg||Standard Deviation|Mean
1283124|NCT00232583|Secondary|Bet-cell Function Measured by Disposition Index|Disposition index was measured by multiplying the insulin secretion (C-peptide AUC/C-peptide AUC glucose) by the Matsuda index. Disposition index reflects the beta-cell function adjusted for total body insulin sensitivity|72 months||||index||Standard Deviation|Mean
1283125|NCT00232583|Secondary|Insulin Sensitivity as Measure be Matsuda Index|C-peptide-based Matsuda index using following formula: Matsuda index = 500,00 / root square [(fasting c-peptide x fasting glucose x 333) x (average c-peptide 0-120 mins x average glucose 0-120 mins x 333). Higher the Matsuda index, better the insulin sensitivity.|72 months||||index||Standard Deviation|Mean
1283126|NCT00232583|Primary|Beta-cell Function - C-peptide AUC (Area Under the Curve)|C-peptide AUC during a 3-hours mixed meal challenge testing|72 months||||ng*min/mL||Standard Deviation|Mean
1283127|NCT00232557|Secondary|Participants With Oral Corticosteroid Use|Number of participants found to have any use of oral corticosteroids related to asthma during one year|1 year||||participants|||Number
1283128|NCT00232557|Primary|Participants With Unscheduled Asthma-related Visits|Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.|1 year||||participants|||Number
1283129|NCT00232544|Secondary|Daytime Vigilance|A measure of behavioral alertness. Specifically the metric we used was the mean reaction time, the time it took for a subject to respond to a visual stimulus (light displayed on a screen at random intervals) by hitting a button.|12 months||||ms||95% Confidence Interval|Mean
1283130|NCT00232544|Primary|Objective CPAP Use|Mean nightly hours of CPAP use over 12 months|12 months||||log(hours/night)||95% Confidence Interval|Mean
1283131|NCT00232505|Secondary|Progression-Free Survival|Time to disease progression of cetuximab or cetuximab + carboplatin as indicated by radiographic assessment|Every four months until progression, death of any cause, or end of data collection up to 40 months||||participants|||Number
1283132|NCT00232505|Secondary|Overall Survival|Subjects will be contacted every 4 months after discontinuation of active treatment to assess survival.|Every four months until death of any cause or end of data collection up to 40 months||||participants surviving|||Number
1283133|NCT00232505|Primary|Overall Disease Response Rate|Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radiographic response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).Per RECIST v1.0 for target lesions and assessed by CT (spiral): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|5 years||||Participants|||Count of Participants
1283134|NCT00232479|Secondary|Safety and Tolerability|the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability|from the first dose of chemotherapy until surgery which was approximately 16 weeks.|48 patients signed an initial informed consent. 2 withdrew consent before treatment. 2 withdrew after starting treatment. Only 44 are evaluable for primary endpoint because 2 did not go for surgery.|||participants|||Number
1283135|NCT00232479|Primary|Number of Patients With Pathologic Complete Response (pCR)|pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.|determined at the time of surgery which is approximately 16 weeks from the beginning of treatment|48 patients signed consent but only 44 were evaluable. To be evaluable the patient must have received at least one dose of chemo and then had surgery. Two patients withdrew consent before treatment and two patients did not have surgery. So 44 are evaluable for the primary endpoint|||participants|||Number
1283136|NCT00232180|Secondary|Number of Participants With New Onset Diabetes Mellitus (DM)|The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of diabetes mellitus at baseline and “n” signifies participants evaluated at that time point.|||participants|||Number
1283137|NCT00232180|Secondary|Number of Participants With New Onset Atrial Fibrillation or Flutter|New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of atrial fibrillation at baseline and “n” signifies participants evaluated at that time point.|||participants|||Number
1283138|NCT00232180|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)|First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283139|NCT00232180|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)|First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283140|NCT00232180|Secondary|Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)|First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283141|NCT00232180|Secondary|Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)|First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283142|NCT00232180|Secondary|Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)||Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283143|NCT00232180|Secondary|Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)||Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1284128|NCT00209339|Secondary|Device Time|Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC.|At day 0 (on the day of index procedure)||||Minutes||Standard Deviation|Mean
1283144|NCT00232180|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)|First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283145|NCT00232180|Secondary|Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)|Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283146|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)|Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283147|NCT00232180|Secondary|Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)|First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283148|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)|Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283149|NCT00232180|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283150|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)|Death due to any cause.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283151|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)|Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
1283164|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283152|NCT00232180|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol.|||participants|||Number
1283153|NCT00232180|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)|Full analysis set (FAS) using intent-to-treat (ITT) principle: All randomized participants, followed for mortality, other major endpoints for duration of double blind treatment period, regardless of compliance with study drug and protocol. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1283154|NCT00232141|Secondary|Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table|Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14).|Baseline-Week 14 (Endpoint)|ITT Population|||participants|||Number
1283155|NCT00232141|Secondary|Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table|Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14)|Baseline-Week 14 (Endpoint)|ITT Population; Pregabalin weight range- 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived. Placebo weight range- 2.83, 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived|||participants|||Number
1283156|NCT00232141|Secondary|Gracely Pain Scale Score|The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment.|Week 14|ITT Population|||score on scale||Standard Deviation|Mean
1283157|NCT00232141|Secondary|Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)|Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline, Week 14|ITT Population|||participants|||Number
1283158|NCT00232141|Secondary|Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)|Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline, Week 14|ITT Population|||participants|||Number
1283159|NCT00232141|Secondary|Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks|Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline-Week 14 (Endpoint)|ITT Population|||participants|||Number
1283160|NCT00232141|Secondary|Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain|Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline-Week 14 (Endpoint)|ITT Population|||participants|||Number
1283161|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283162|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283163|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283165|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283166|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283167|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283168|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283169|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283170|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283171|NCT00232141|Secondary|Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283172|NCT00232141|Secondary|Shift in Hospital Anxiety and Depression (HADS) Subscales|Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.|Baseline, Week 14|ITT Population|||participants|||Number
1283173|NCT00232141|Secondary|Change in NRS-Sleep Interference Scores|Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.|Baseline, Weeks 1-14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283174|NCT00232141|Other Pre-specified|Duration Adjusted Average Change From Baseline in NRS Pain Scores|Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation – mean at baseline)x(proportion of planned study duration that the subject completed).|Weekly: Week 1 - Week 14|ITT Population|||score on scale||Standard Error|Least Squares Mean
1283175|NCT00232141|Secondary|Change in Quantitative Assessment of Neuropathic Pain (QANeP)|Change in a quantitative assessment of the participants’ neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283176|NCT00232141|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283177|NCT00232141|Secondary|Patient Global Impression of Change (PGIC) Rating|PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).|Baseline, Week 14, Endpoint-LOCF|ITT Population|||participants|||Number
1288790|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg|24-hour fed Leptin dose 0.1 mg/kg|1 DAY||||HR||Standard Deviation|Mean
1283180|NCT00232141|Secondary|Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores|Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from “no pain” (0) to “pain as bad as you can imagine” (10)|Baseline, Week 14|ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283181|NCT00232141|Secondary|Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales|Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).|Baseline, Week 14|ITT population|||score on scale||Standard Error|Least Squares Mean
1283182|NCT00232141|Secondary|Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices|Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 – 100 and higher scores reflect more impairment. Subscales “sleep adequacy”, “quantity of sleep” and “optimal sleep” low scores reflect impairment.|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283183|NCT00232141|Other Pre-specified|Responders - Decreases of at Least 30% in Mean Weekly Pain Score|Number of subjects that experienced at least 30% decrease in mean weekly pain.|Weeks 1-14 endpoint BOCF|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo); BOCF = modified baseline observation carried forward|||participants|||Number
1283184|NCT00232141|Other Pre-specified|Responders- Decreases of at Least 50% in Mean Weekly Pain Score|Number of subjects that experienced at least a 50% decrease in mean weekly pain.|Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo), BOCF = modified baseline observation carried forward|||participants|||Number
1283185|NCT00232141|Other Pre-specified|Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)|Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR)|Baseline, Weeks 1 - 14 and Endpoint-BOCF|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1283186|NCT00232141|Primary|Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline|Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 14|ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose & had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99).|||score on scale||Standard Error|Least Squares Mean
1283187|NCT00231894|Secondary|Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) China Site||pretreatment and during 3 months of drug treatment|Data is from participants at china. site N=10, Pioglitazone =5, Placebo =5, who had values of HDL at baseline and three months followup. See of published paper and its supplementary data paper cited in reference for further details|||mg/dL||Standard Error|Least Squares Mean
1283188|NCT00231894|Secondary|2 Hour Glucose From Glucose Tolerance Test China Sample|difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment|between baseline and 3 months of study drug treatment|Data is from participants at china site N=10, Pioglitazone =5, Placebo =5, who had values of serum glucose at 2-hour point in glucose tolerance test at baseline and three months follow-up. See published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
1283189|NCT00231894|Secondary|Change From Baseline in Serum Triglycerides at 3 Months (3 Months-baseline) China Sample||pretreatment and during 3 months of drug treatment|Data is from participants at China site N=10, Pioglitazone =5, Placebo =5, who had values of triglycerides at baseline and three months followup. See published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
1283190|NCT00231894|Secondary|Change From Baseline in Serum Glucose at 3 Months ( 3 Months -Baseline) China Sample||pretreatment and during 3 months of drug treatment|Data is from participants at China site N=10, Pioglitazone =5, Placebo =5, who had values of fasting glucose at baseline and three months follow-up. See published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
1283191|NCT00231894|Secondary|Change in RBANS List Recognition Scores at 3 Months (3 Months-baseline) US Sample|The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measure cognitive function in patients with schizophrenia. Range for list learning sub-score is 0 to 20 . Higher values indicate better performance. For change score (3 months -baseline) positive values indicate improved performance for this cognitive function and negative values indicate poorer performance on this cognitive function.|pre-treatment and 3 months of treatment|Data is from participants at U.S. sites N=43, Pioglitazone =25, Placebo =18, who had scores of RBANS List learning at 2-hour point at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.|||Units on RBANS scale||Standard Error|Least Squares Mean
1283192|NCT00231894|Primary|2 Hour Glucose From Glucose Tolerance Test US Sample|difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment|between baseline and 3 months of study drug treatment|Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of serum glucose at 2-hour point in glucose tolerance test at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
1283193|NCT00231894|Primary|Change From Baseline in Serum Glucose at 3 Months (3 Months-baseline) US Sample||pretreatment and during 3 months of drug treatment|Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of serum glucose at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
1283194|NCT00231894|Primary|Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) US Sample|serum high density lipoprotein (HDL)|pre-treatment and during 3 months of treatment|Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of HDL at baseline and three months followup. See table 2 of published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
1283195|NCT00231894|Primary|Change From Baseline in Serum Triglycerides at 3 Months ( 3 Months-baseline) US Sample||pre-treatment and during 3 months of treatment|Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of triglycerides at baseline and three months followup. See table 2 of published paper given in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
1283196|NCT00231816|Other Pre-specified|GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP|||titers||95% Confidence Interval|Geometric Mean
1283197|NCT00231816|Other Pre-specified|GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.|||titers||95% Confidence Interval|Geometric Mean
1283198|NCT00231816|Other Pre-specified|Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.|||titers||95% Confidence Interval|Geometric Mean
1283199|NCT00231816|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination|"GMFR of the VZV gpELISA antibody titers from prevaccination~to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine"|prevaccination to 4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid GMFR results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)|||ratio||95% Confidence Interval|Geometric Mean
1283200|NCT00231816|Primary|Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses|The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.|4 weeks|The primary analysis was based on the per protocol population defined as participants who had valid GMT results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP).|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1283201|NCT00231777|Secondary|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.|||Participants|||Number
1283202|NCT00231777|Secondary|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.|||Participants|||Number
1283203|NCT00231777|Primary|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline and 24 hours|"All patients as treated (APaT) which included all patients who received active study therapy.~patients in the MK0517 40 mg treatment group were randomized but did not have at least one post-baseline laboratory test and therefore were not counted as part of the N analyzed."|||Participants|||Number
1283204|NCT00231777|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.|||Participants|||Number
1283205|NCT00231478|Secondary|Adverse Experiences|The adverse events are captured in the AE and SAE section of this database|infusion to 15 days post treatment|Eight of the 157 treated subjects (six and two in the 20- and 40-μg/kg dose groups,respectively) experienced a treatment-emergent serious adverse event up to 15 days after the treatment evaluation period.|||Number of participants assessed|||Number
1283206|NCT00231478|Secondary|Time to First Vomiting Episode|Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up.|0-24h after time of extubation|Evaluable Patients|||hours||Standard Error|Mean
1283207|NCT00231478|Secondary|Number of Patients With no Vomiting|No vomiting describes no emesis during the first 24 hours|0-24h after time of extubation|Evaluable Patients|||participants|||Number
1283209|NCT00231465|Secondary|Overall Survival (OS) Rate|OS was calculated from the date of enrollment to the date of death. All 44 treated were assessed for OS, with a minimum follow-up of 19 months.|Duration of time on study, an average of 19 months|All participants who initiated therapy between March 2003 and May 2005|||Months||95% Confidence Interval|Median
1283210|NCT00231465|Secondary|Progression Free Survival (PFS) Rate|PFS was calculated from the date of enrollment to the date of progression. All 44 treated were assessed for PFS, with a minimum follow-up of 19 months. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Duration of time on study, an average of 19 months|All participants who initiated therapy between March 2003 and May 2005|||Months||95% Confidence Interval|Median
1283211|NCT00231465|Primary|Overall Response Rate (ORR)|ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (MPE)) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): * Complete Response (CR)- Disappearance of all target lesions; * Partial Response (PR)- At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; * Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; * Stable Disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Duration of time on study, an average of 19 months|Response was evaluable in 42 of the 44 patients.|||percentage of participants||95% Confidence Interval|Mean
1283212|NCT00231309|Secondary|Hospital Length of Stay|hospital length of stay of each patient enrolled, an average of 5 weeks.|inpatient hospital stay||||average days||Standard Deviation|Median
1283213|NCT00231309|Primary|Numbers of Participants With Disease-free Survival.|Evaluate the numbers of participants with disease-free survival|260 days||||participants|||Number
1283214|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to 12 months|Patients who had at least 330 days clinical follow-up.|||Percentage of participants|||Number
1283215|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to hospital discharge|Patients who were followed up to hospital discharge|||Percentage of participants|||Number
1283216|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to 30 days|Patients who had 30 days clinical follow-up.|||Percentage of Participants|||Number
1283217|NCT00231283|Primary|Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge|Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion|From post-procedure up to hospital discharge|Patients who were followed up to hospital discharge|||Percentage of Participants|||Number
1283218|NCT00231179|Primary|Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|child age 5 years (plus or minus 1 month)||||Percentage of participants|||Number
1283219|NCT00231179|Primary|Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)||||Percentage of participants|||Number
1283220|NCT00231179|Primary|Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)||||percentage of participants|||Number
1283276|NCT00229970|Primary|The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)|The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor|baseline over the first 60 minutes|Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS)|||Liter||95% Confidence Interval|Least Squares Mean
1283221|NCT00231179|Primary|Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)|Number of mothers/caregivers evaluated at 60 month visit.|||percentage of participants|||Number
1283222|NCT00231179|Primary|Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)|Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value).|5 years of age (plus or minus 1 month)|Number of children evaluated at 60 month visit.|||Scores on a scale||Standard Deviation|Mean
1283223|NCT00231153|Secondary|Catheter Colonization (CC)|CC was defined as a positive culture of any catheter segment >= 15 CFU (roll-plate method) or >999 CFU/ml (sonication method) or a positive blood culture drawn via the catheter where the time-to-positivity difference of catheter line vs. peripheral blood >120 minutes (catheter positive first).|study completion|MITT Among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for catheter colonization prior to death (as determined EC adjudication).|||Events|||Number
1283224|NCT00231153|Secondary|Microbiologically-confirmed LCSI|MCLCSI is a subset of EC-adjudicated LCSI for any catheter where there is (1) growth of a recognized pathogen from a culture or any purulence or exudate from the same insertion site, or (2) a positive culture of the subcutaneous segment of the catheter meeting criteria for significant colonization.|study completion|MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for MCLCSI prior to death (as determined by EC adjudication).|||Events|||Number
1283225|NCT00231153|Primary|Local Catheter Site Infection (LCSI)|LCSI was defined as a study catheter showing any 2 of the following criteria: erythema >= 2; edema >= 2; presence of purulence, pain, or abnormal study catheter site warmth. In addition, an action must have been taken that indicated a LCSI was present.|study completion|MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for LCSI prior to death (as determined by EC adjudication).|||Events|||Number
1283226|NCT00231114|Other Pre-specified|Hospitalizations for Respiratory Symptoms||12 Months||||Events/Subject/Year|||Number
1283227|NCT00231114|Other Pre-specified|Emergency Room Visits for Respiratory Symptoms||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Events/Subject/Year||Standard Deviation|Mean
1283228|NCT00231114|Other Pre-specified|Unscheduled Physician Office Visits for Respiratory Symptoms||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Events/Subject/Year||Standard Deviation|Mean
1283229|NCT00231114|Other Pre-specified|Days Lost From Work/School/Other Activities Due to Asthma||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Days/Subject/Year||Standard Deviation|Mean
1283230|NCT00231114|Other Pre-specified|Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids|Percent of subjects experiencing worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent of Subjects|||Number
1283231|NCT00231114|Other Pre-specified|Rate of Severe Exacerbations Requiring Systemic Corticosteroids|Rate of occurrence of worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Events/Subject/Year||Standard Deviation|Mean
1283232|NCT00231114|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent Change||Standard Deviation|Mean
1283233|NCT00231114|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent Change||Standard Deviation|Mean
1283234|NCT00231114|Secondary|Morning Peak Expiratory Flow (amPEF) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||L/Min||Standard Deviation|Mean
1283277|NCT00229957|Secondary|Patient Satisfaction Questionnaire - 18 (Modified)|Patient satisfaction with the care they received. (Score range 0-5)|15 months|||||||
1283765|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)|Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).|32 Weeks||||percentage of randomized|||Number
1283235|NCT00231114|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient’s FEV1 value (% Predicted) that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Units on a scale||Standard Deviation|Mean
1283236|NCT00231114|Secondary|Percent Days Rescue Medication Used (Change From Baseline)|Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent Change||Standard Deviation|Mean
1283237|NCT00231114|Secondary|Number of Puffs of Rescue Medication Used (Change From Baseline)|Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Puffs/7 Days||Standard Deviation|Mean
1283238|NCT00231114|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Units on a scale||Standard Deviation|Mean
1283239|NCT00231114|Secondary|Percent Symptom-Free Days (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent Change||Standard Deviation|Mean
1283240|NCT00231114|Primary|Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|"Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the “Integrated AQLQ Score."|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Units on a scale||Standard Deviation|Mean
1283241|NCT00231062|Secondary|Number of Participants Experiencing Relief of Sinus Symptoms|To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated.|Week 24|All patients treated per protocol; includes all subjects not lost to follow-up at 24 weeks and who completed symptom questionnaire|||Participants|||Number
1283242|NCT00231062|Primary|Number of Participants With Adverse Events Following Sinuplasty Procedure|Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).|24 weeks|Analysis per protocol; based on subjects not lost to follow-up at 24 weeks|||Participants|||Number
1283243|NCT00231062|Primary|Number of Sinuses With Patency of Sinus Ostium After Sinuplasty|Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.|24 weeks|Analysis per Protocol; based on all sinuses of subjects not lost to follow-up at 24 weeks|||Sinuses|Participants||Number
1283244|NCT00230971|Secondary|Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure|Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization|up to 6 weeks|All patients who received at least 1 dose of study drug.|||days||Standard Deviation|Mean
1283245|NCT00230971|Secondary|Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.|up to 6 weeks|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.|||participants|||Number
1283263|NCT00230100|Post-Hoc|Client Satisfaction for Women|"Participant satisfaction with the groups was assessed using the Client Satisfaction Questionnaire (CSQ-8) plus four additional questions about the helpfulness of the therapist, group content, and group composition. Questions were answered on a 4-point scale where 1 reflected negative feelings and 4 reflected positive feelings. Participants' scores are calculated by adding up the numbers assigned to their chosen answers. Therefore, scores can range between 12 and 48, with higher scores reflecting greater satisfaction.~The CSQ was administered at week 3, 6, 9, and 12 while participants were in treatment. Scores represent calculated averages of the group averages for week 3, week 6, week 9, and week 12."|In treatment phase (week 1-12)|Only women were included in this analysis.|||units on a scale||Full Range|Mean
1283246|NCT00230971|Secondary|Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit|ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|up to 6 weeks|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.|||participants|||Number
1283247|NCT00230971|Primary|Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit|CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.|up to 6 weeks|All patients who received at least 1 dose of study drug who had clinical evidence of a complicated intra-abdominal infection (cIAI) and completed the test-of-cure (TOC) assessment of cure or failure within 8 to 44 days after the last administration of study article. Patients with an indeterminate assessment were excluded.|||participants|||Number
1283248|NCT00230802|Secondary|Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.||9 months||||participants|||Number
1283249|NCT00230802|Secondary|the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State||9 months||||participants|||Number
1283250|NCT00230802|Primary|Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation|The proportion of patients in each treatment arm euthyroid through gestation|9 months|proportion of patients in each treatment arm euthyroid through gestation|||participants|||Number
1283251|NCT00230737|Primary|Peak Melatonin Level|Pharmacokinetic analysis of maximum melatonin level|day 42||||pg/ml||Standard Error|Mean
1283252|NCT00230282|Secondary|Duration of Response||105 months||||months||Full Range|Median
1283253|NCT00230282|Primary|Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR)|"Response criteria as per the NCI-WG Revised Guidelines for B-CLL~Complete remission:~No lymphadenopathy by physical exam No hepatomegaly or splenomegaly Absence of constitutional symptoms Polymorphonuclear leukocytes > 1,500/uL, Platelets > 100,000/uL, Hemoglobin > 11.0 g/dL Bone marrow aspirate and biopsy normocellular with < 30% lymphocytes Absent lymphoid nodules~Partial remission:~50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value~50% reduction in lymphadenopathy and/or ≥ 50% reduction in the size of the liver and/or spleen AND one or more of the following Polymorphonuclear leukocytes > 1,500/uL or 50% improvement over baseline Platelets > 100,000/uL or 50% improvement over baseline Hemoglobin > 11.0 g/dL or 50% improvement over baseline"|24 weeks||||participants|||Number
1283254|NCT00230178|Secondary|Time to Uric Acid Control|Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.|Day 1 to Day 7|The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug.|||Hours||95% Confidence Interval|Median
1283255|NCT00230178|Secondary|Plasma Uric Acid|Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values|Day 1 to Day 7|The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC.|||mg*h/dL||Standard Deviation|Mean
1283256|NCT00230178|Primary|Plasma Uric Acid Responder|Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.|Day 3 through Day 7||||Participants|||Number
1283257|NCT00230126|Primary|1-year Survival Rate||12 months||||percentage of patients|||Number
1283258|NCT00230126|Primary|Time to Progression||Every 12 weeks||||months||95% Confidence Interval|Median
1283259|NCT00230126|Primary|Disease Control Rate at 12 Weeks|no progression of disease at 12 weeks from starting treatment|12 weeks||||participants|||Number
1283260|NCT00230100|Other Pre-specified|Baseline Addiction Severity Index Alcohol Composite Score for Women|The data reflect baseline characteristics of the participants with respect to ASI alcohol composite score. Scores range between 0 and 1. Higher scores reflect higher addiction severity. The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status.|Baseline|Only women were included in this analysis.|||units on a scale||Standard Error|Mean
1283261|NCT00230100|Other Pre-specified|Baseline Drinks Per Drinking Day for Women|The data reflect baseline characteristics of the women participants with respect to the number of drinks per drinking day in the 60 days prior to baseline intake. This was measured using the Timeline Follow-Back.|Baseline|Only women were included in this analysis.|||Drinks per drinking day||Standard Error|Mean
1283262|NCT00230100|Other Pre-specified|Baseline Substance Use Data for Women|The data reflect baseline characteristics of women participants with respect to (1) days of any substance use (i.e. drugs or alcohol), and (2) the number of drinking days, in the 60 days prior to baseline intake.This data was collected using the Timeline Follow-Back.|Baseline|Only women were included in this analysis.|||Days||Standard Error|Mean
1283275|NCT00230009|Primary|Alcohol Use|Alcohol use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported at the 3 month follow-up. The mean of each the control and intervention group was used. Frequency of use ranged from 0 to 5 for the follow-up sample. Higher scores mean more frequent use of the substance.|3 month follow-up|A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.|||units on a scale||Standard Deviation|Mean
1288791|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg|24-hour fed Leptin dose 0.01 mg/kg|1 DAY||||NG*H/ML||Standard Deviation|Mean
1283264|NCT00230100|Secondary|Change in Mean Addiction Severity Index Alcohol Composite Score for Women|"This represents the change from baseline in mean composite scores of the Addiction Severity Index (ASI) alcohol section. The ASI was administered at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.~The ASI is a widely employed multidimensional assessment of substance-related problems. Scores range from 0-1 where higher scores reflect higher addiction severity."|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.|||units on a scale||Standard Error|Mean
1283265|NCT00230100|Secondary|Change in Mean Number of Drinks Per Drinking Day for Women|This represents the change from baseline in the mean number of drinks per drinking day for women. The number of drinks per drinking day was measured using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.|||Drinks per drinking day||Standard Error|Mean
1283266|NCT00230100|Primary|Change in Mean Number of Drinking Days for Women|This represents the change from baseline in the mean number of drinking days for women. Number drinking days was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.|||Drinking days||Standard Error|Mean
1283267|NCT00230100|Primary|Change in Mean Days of Any Substance Use for Women|This represents the change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol). Days of substance use was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.|||Days of any substance use per month||Standard Error|Mean
1283268|NCT00230048|Primary|Treatment Engagement|Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.|3 months|ITT, treating all participants lost to follow up as failures (i.e., not receiving any treatment services)|||participants|||Number
1283269|NCT00230048|Primary|Number of Participants With Drug Use at 3 Months|The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive.|3 months|Intent to treat, treating participants lost to follow-up as positive.|||participants|||Number
1283270|NCT00230022|Primary|Motivation to Change Substance Use|An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change.|One month|A total of 30 participants were included in this pilot trial, based primarily on convenience and timeframe. The primary goal was effect-size estimation, so power was not a primary concern. Last Observation Carried Forward(LOCF) was utilized for 8 participants lost to follow-up.|||units on a scale||Standard Deviation|Mean
1283271|NCT00230009|Primary|Treatment Engagement|The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).|at 3 month follow-up||||participants|||Number
1283272|NCT00230009|Secondary|Depression|Depression was measured by using the Center for Epidemiologic Studies Depression Scale (CES-D) at the 3 month follow-up. CES-D total scores can range from 0 to 60. Scores at 16 or higher indicate clinical significance. Higher scores represent higher risk for depression.|at 3 month follow-up||||units on a scale||Standard Deviation|Mean
1283273|NCT00230009|Primary|Child Abuse Potential|Change score was calculated by taking the follow-up scores on the Brief Child Abuse Potential Inventory (BCAP) and subtracting the baseline score. The possible total score for the BCAP ranges from 0 to 24. Therefore, the possible range of scores for the change calculation (reported below) is -24 to +24. Higher scores indicate higher risk at the follow-up visit (worse outcome).|baseline and 3 month follow-up||||units on a scale||Standard Deviation|Mean
1283274|NCT00230009|Primary|Drug Use|Drug use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported about marijuana use at the 3 month follow-up. The mean of each the assessment only and intervention group was used. Scores ranged from 0 to 13 for the follow-up sample. Higher scores mean more frequent use of the substance.|3 month follow-up|A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.|||units on a scale||Standard Deviation|Mean
1285211|NCT00194792|Primary|Overall Survival|From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.|Up to 5 years||||survival probability||95% Confidence Interval|Number
1283278|NCT00229957|Secondary|Physical Abilities (Strength, Balance)|Grip strength was measured using a JAMAR hand grip dynamometer (in kilograms). The Lower Extremity Function test is a battery of three tests used to measure lower extremity function and balance: a balance test, 8 foot walk test, and repetitive standing from a chair. A performance summary score is created by adding the number of seconds achieved on the balance test, the number of seconds to walk 8 feet and the number of seconds it takes the person to stand up from a chair five times consecutively (no maximum score exists on this measure).|baseline, 15 months||2009-08-31|08/2009||||
1283279|NCT00229957|Secondary|Self-management and Self-efficacy|Individual's self-reported ability to carry out behaviours to self-manage their health condition, and their confidence level in being able to carry out these behaviours. (Score range 0= not confident at all, 10= totally confident).|baseline, 15 months||2009-08-31|08/2009||||
1283280|NCT00229957|Secondary|HOME Falls and Accident Screening Tool (FAST)|This is a home assessment of safety hazards for falls present in the individual's home. This tool helps to identify seniors at risk of falls. Score 0-25.|baseline, 15 months||2009-08-31|08/2009||||
1283281|NCT00229957|Secondary|Falls and Injuries|self-reported number of falls in last 6 months|baseline, 15 months||2009-08-31|08/2009||||
1283282|NCT00229957|Secondary|Functional Limitations|Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.|baseline, 15 months||2009-08-31|08/2009||||
1283283|NCT00229957|Secondary|Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)|Late Life Function and Disability Instrument: A measure of disability and functional limitations in older adults. (Score range 0-100 with 100 representing better ability and less disability/functional limitation)|baseline, 15 months||2009-08-31|08/2009||||
1283284|NCT00229957|Secondary|Use of Hospital Services|self report use of hospital service|baseline, 15 months||2009-07-31|07/2009||||
1283285|NCT00229957|Primary|SF-36 Physical Component|health related quality of life. Minimum: 0; Maximum 100.|15 months||||units on a scale||Standard Deviation|Mean
1283286|NCT00229931|Secondary|Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage.||3 years|Data were not collected||||||
1283287|NCT00229931|Primary|Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.||3 years|Due to lack of follow up from patients, this outcome was not analyzed; data were not collected||||||
1283288|NCT00229723|Secondary|Safety and Tolerability||Assessed over two years|||||||
1283289|NCT00229723|Secondary|Overall Survival|Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).|Overall survival assessed at 2 years||||Percentage of participants|||Number
1283290|NCT00229723|Secondary|Progression Free Survival|Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).|Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)||||Percentage of participants|||Number
1283291|NCT00229723|Secondary|Tumour Response (Complete Response + Partial Response)|A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.|Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression||||Participants|||Number
1283292|NCT00229723|Secondary|Complete Response|A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.|Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.||||Participants|||Number
1283293|NCT00229723|Secondary|Local Disease Control Rate at 1 Year|A patient demonstrated local disease control at 1 year if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.|Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).||||Participants|||Number
1283294|NCT00229723|Primary|Local Disease Control Rate at 2 Years|A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.|Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).||||Participants|||Number
1283295|NCT00229658|Secondary|Change in Body Weight From Baseline at Month 6|Mean change in body weight from baseline at month 6|6 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses|||kg||Standard Error|Mean
1283296|NCT00229658|Secondary|Change in Body Weight From Baseline at Month 3|Mean change in body weight from baseline at month 3|3 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses|||kg||Standard Error|Mean
1283297|NCT00229658|Secondary|Change in HbA1c From Baseline at Month 6|Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.|6 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses|||percent||Standard Error|Mean
1283298|NCT00229658|Secondary|Change in HbA1c From Baseline at Month 3|Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.|3 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses|||percent||Standard Error|Mean
1283311|NCT00229203|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death|Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed.|Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients)|||months||Full Range|Median
1283299|NCT00229658|Secondary|Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)|||Events per patient year|||Number
1283300|NCT00229658|Secondary|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period|"The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)|||Incidence (%)|||Number
1283301|NCT00229658|Secondary|The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|0-3 months|Intent-to-Treat|||Events per patient year|||Number
1283302|NCT00229658|Secondary|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period|MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH. The adjustment period represents the initial 0-3 months of pramlintide treatment|0-3 months|Intent-to-Treat.|||Incidence (%)|||Number
1283303|NCT00229658|Secondary|The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)|||Events per patient year|||Number
1283304|NCT00229658|Secondary|The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period|"The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)|||Incidence (%)|||Number
1283305|NCT00229658|Primary|Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|0-3 months|Intent-to-Treat|||Events per patient year|||Number
1283306|NCT00229658|Primary|Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period|PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment|0-3 months|Intent-to-Treat|||Incidence (%)|||Number
1283307|NCT00229619|Secondary|Response Rates at 12 Months (After the First Dose of Study Med)||12 months||||Participants|||Count of Participants
1283308|NCT00229619|Secondary|Response Assessment at 3 Months||3 months||||Participants|||Count of Participants
1283309|NCT00229619|Primary|Response to Rituximab|"Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.~Primary endpoint will determine immune response by evaluating changes in peripheral blood counts (platelets, absolute neutrophil count, reticulocyte count, hemoglobin) and transfusion requirements at 6 months. The response wil be will be categorized as complete, partial or no response. Subjects will be categorized as complete responders if their blood counts return to normal. Subjects will categorized as partial responders if there is an improvement in 2 or 3 of the depressed baseline blood counts."|6 months||||participants|||Number
1283310|NCT00229203|Secondary|Number of Patients With Overall Survival (OS)|Overall Survival (OS): time from the date of first infusion to the date of documented death|Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed.|Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients. For patient of group plitidepsin + dexamethasone the median overall survival could not be calculated due to follow-up short duration. The survival rates at 6 and 12 months are provided instead.|||percentage patients|||Number
1283394|NCT00227370|Secondary|Ganciclovir Resistance|UL97 genotyping was done on all positive samples for CMV DNA at 1000 copies/mL, with resistance defined by the presence of 1 or more mutations shown by marker transfer to confer phenotypic ganciclovir resistance|over the course of 300 days post randomization|intention to treat|||participants|||Number
1283312|NCT00229203|Secondary|Time to Progression (TTP)|Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as >25 percentage increase in level of serum monoclonal paraprotein.|Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed.|Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)|||months||Full Range|Median
1283313|NCT00229203|Primary|Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response|"Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: >25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.~Treatmen failure: Reappearance of serum or urinary paraprotein"|Every 2 weeks until progression or death occurs.|Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)|||percentage patients|||Number
1283314|NCT00228943|Primary|Objective Subject Hot Flash Frequency|Mean of the 24 hour monitoring sessions for each patient based on one 24 hour monitoring session after each intervention using an electronic monitor.|One 24 hour monitoring session per week for 8 weeks|Subjects with completed hot flash data during both arms of study.|||frequency of hot flashes||Standard Deviation|Mean
1283315|NCT00228943|Primary|Serum Tryptophan Levels|Mean serum tryptophan levels (blood draw) at the end of the nadir period.|baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours|The number of subjects with complete serum data for both arms of the study were analyzed.|||nmol/ml||Standard Deviation|Mean
1283316|NCT00228917|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604).|||Subjects|||Number
1283317|NCT00228917|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) following booster vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604).|||Subjects|||Number
1283318|NCT00228917|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after booster vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604), only taking into account those subjects who returned their symptom sheets.|||Subjects|||Number
1283319|NCT00228917|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604), only taking into account those subjects who returned their symptom sheets.|||Subjects|||Number
1283320|NCT00228917|Primary|Number of Subjects With Fever >39°C (Rectal Route).|Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C.|During the 4-day (Day 0-3) follow-up period after booster vaccination|This analysis was performed on the Pooled Booster Total Vaccinated cohort included all subjects from the groups that were in common to the two studies (NCT00228917 & NCT00136604), only taking into account those subjects who returned their symptom sheets.|||Subjects|||Number
1283321|NCT00228813|Primary|Incidence of Chronic Graft-versus-host Disease|The number of participants diagnosed with chronic graft-versus-host disease (GVHD).|Duration of Study (Up to two years)|Participants who survived beyond Day 100 post bone marrow transplant.|||participants|||Number
1283322|NCT00228813|Primary|Incidence of Acute Graft-versus-host Disease|The number of participants diagnosed with new acute graft-versus-host disease (GVHD).|Day 100|Participants who who developed acute GVHD was measured at Day 100 post bone marrow transplant.|||participants|||Number
1283323|NCT00228813|Primary|Engraftment Rate|The number of participants who received in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donor who reached engraftment by Day 45.|Day 45||||particpants|||Number
1283324|NCT00228566|Primary|Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings|A subjective measure (PGI-C rating) of the patient’s global health, ie, a patient’s rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.|Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.||||Participants|||Number
1285212|NCT00194792|Primary|Disease-free Survival|Kaplan-Meier estimate assessed at 5 years|Up to 5 years||||disease free survival probability||95% Confidence Interval|Number
1283325|NCT00228553|Primary|Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)|An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.|End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year|Safety Analysis set of 731 total patients: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug.|||Participants|||Number
1283326|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the X-ray assessment.|||percentage of participants|||Number
1283327|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.|2 years|The number of participants analyzed is the number of subjects that returned for the 2yr follow-up and completed the X-ray assessment.|||percentage of participants|||Number
1283328|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.|1 year|The number of participants analyzed is the number of subjects that returned for the 1yr follow-up and completed the X-ray assessment.|||percentage of particpants|||Number
1283329|NCT00228384|Secondary|Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)|The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0.|3 years||||percentage of subjects||95% Confidence Interval|Number
1283330|NCT00228384|Secondary|Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)|The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5.|3 years||||percentage of subjects||95% Confidence Interval|Number
1283331|NCT00228384|Secondary|Change in Ankle-Brachial Index (ABI)|"This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.~A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal.~An outcome of a higher mean ABI is considered a success."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and had the ABI completed and recorded.|||ABI Value||Standard Deviation|Mean
1283332|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)|"The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.~The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.|||Score||Standard Deviation|Mean
1283333|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)|"The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.~The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.|||Score||Standard Deviation|Mean
1283334|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)|"The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire.~Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline."|3 years|Number of subjects that returned for 3yr follow-up appointment and completed the ICQ.|||Score||Standard Deviation|Mean
1283335|NCT00228384|Secondary|Improvement in Rutherford Classification (Clinical Success)|"The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|3 years|The number of participants analyzed was the number of subjects that returned for the 3yr follow-up visit and for which we had data.|||percentage of participants|||Number
1283336|NCT00228384|Secondary|Target Lesion Revascularization (TLR)|This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study.|3 years||||percentage of participants|||Number
1283337|NCT00228384|Secondary|Target Vessel Revascularization (TVR)|This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.|3 years||||percentage of participants|||Number
1283338|NCT00228384|Secondary|Technical Success at Initial Procedure|"Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow.~The results show the percentage of study subjects that had technical success."|Time of implant procedure|The number of participant analyzed were those for which we had data. Not all sites recorded both measures required to calculate technical success.|||percentage of subjects|||Number
1283339|NCT00228384|Secondary|Secondary Patency|Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.|3 years||||percentage of subjects||95% Confidence Interval|Number
1283340|NCT00228384|Secondary|Primary Assisted Patency|Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion.|3 years||||percentage of subjects||95% Confidence Interval|Number
1283341|NCT00228384|Primary|Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)|Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.|30 days||||percentage of subjects|||Number
1283342|NCT00228384|Primary|Efficacy: Primary Patency at Three Years|"Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention.~The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years)."|3 years||||percentage of subjects||95% Confidence Interval|Number
1283343|NCT00227994|Secondary|Medication Tolerability|Number of participants who withdrew due to side effects.|Measured throughout the study||||participants|||Number
1283344|NCT00227994|Primary|Physical Function (Measured by the FIM-motor)|Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence|Measured at weeks 0 and 12||||units on a scale||Standard Deviation|Mean
1283345|NCT00227903|Other Pre-specified|Attendance of Treatment Outside the Study|The number of patients who attended outside treatment in the 30 days prior to each assessment.|30 days prior to assessment|all randomized participants with data availabe at time frames|||participants|||Number
1283346|NCT00227903|Other Pre-specified|Adequacy of Received Services|Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.|After prenatal care initiation|All randomized participants, 6 women had unkown attendance.|||participants|||Number
1283347|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.|||proportion of participants|||Number
1283348|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.|||proportion of participants|||Number
1283349|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.|||proportion of participants|||Number
1283350|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.|||proportion of participants|||Number
1283351|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.|||proportion of participants|||Number
1283352|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.|||proportion of participants|||Number
1283353|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.|||proportion of participants|||Number
1283354|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.|||proportion of participants|||Number
1283395|NCT00227370|Secondary|Severity of Viremia|upon diagnosis of cmv disease, the number of CMV DNA copies/mL as measured by PCR|over the course of 300 days after randomization|intention to treat|||CMV copies/mL||Inter-Quartile Range|Median
1283355|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.|||proportion of participants|||Number
1283356|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis of drug abuse or dependence.|||proportion of participants|||Number
1283357|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.|||proportion of participants|||Number
1283358|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug abuse or dependence.|||proportion of participants|||Number
1283359|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine, or opioids.|Delivery to 3 months post-delivery|All randomized participants with both self-report and urine data available during the time frame.|||proportion of participants|||Number
1283360|NCT00227903|Primary|Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.|||percentage of days||Standard Deviation|Mean
1283361|NCT00227903|Primary|Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis for drug abuse or dependence.|||percentage of days||Standard Deviation|Mean
1283362|NCT00227903|Primary|Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.|||percentage of days||Standard Deviation|Mean
1283363|NCT00227903|Primary|Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug use or dependence.|||percentage of days||Standard Deviation|Mean
1283364|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants with both self-report and urine data available.|||proportion of participants|||Number
1283365|NCT00227903|Secondary|Proportion of Participants Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine, or opioids|Delivery to 3 months post-delivery|All randomized participants for whom urine data was available during the time frame.|||proportion of participants|||Number
1283366|NCT00227903|Secondary|Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine||intake to delivery, an average of 21 weeks|All randomized participants for whom urine test data was available.|||proportion of participants|||Number
1283367|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants with data available from the time frame.|||proportion of participants|||Number
1283368|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants|||proportion of participants|||Number
1283369|NCT00227903|Secondary|Incidence of Low Birth Weight||At delivery|Only singleton live births, which occurred in 163 subjects, were analyzed. Three of the women in the MI-CBT group had an infant of unknown birth weight, and were not included in analysis.|||low weight births|||Number
1283370|NCT00227903|Primary|Percentage of Days Used Drugs or Alcohol||delivery to 3 months post-delivery|all randomized participants with data from delivery and 3 months post-delivery|||percentage of days||Standard Deviation|Mean
1283371|NCT00227903|Secondary|Incidence of Preterm Births||At delivery|A singleton live birth occurred in 163 subjects, and 5 had twins. Data was collected from the 84 women of the Brief Advice category and the 79 women of the MI-CBT category who had singleton live births.|||preterm births|||Number
1283372|NCT00227903|Primary|Percentage of Days Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|all randomized participants|||percentage of days||Standard Deviation|Mean
1283373|NCT00227877|Secondary|Any Risky DRWI at 12 Months - Prague, CZR|Any past-90-day reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs (DRWI) at 12 months post-baseline assessment - Prague, Czech Republic|Past-90-days at 12 months post-baseline||||Participants|||Count of Participants
1283374|NCT00227877|Secondary|Any Risky DRWI at 3 Months - Prague, CZR|Any past-90-day reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs (DRWI) at 3 months post-baseline assessment - Prague, Czech Republic|Past-90-days at 3 months post-baseline||||Participants|||Count of Participants
1283375|NCT00227877|Secondary|Any Risky DRWI at 12 Months - New England|Any past-90-day reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs (DRWI) at 12 months post-baseline assessment - New England|Past-90-days at 12 months post-baseline||||Participants|||Count of Participants
1283376|NCT00227877|Secondary|Any Risky DRWI at 3 Months - New England|Any past-90-day reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs (DRWI) at 3 months post-baseline assessment - New England|Past-90-days at 3 months post-baseline||||Participants|||Count of Participants
1283377|NCT00227877|Primary|Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZ|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic|Past-12-months at 12 months post-baseline||||Participants|||Count of Participants
1283378|NCT00227877|Primary|Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZ|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic|Past-12-months at 12 months post-baseline||||Participants|||Count of Participants
1283379|NCT00227877|Primary|Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZ|Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic|Past-90-days at 3 months post-baseline||||Participants|||Count of Participants
1283380|NCT00227877|Primary|Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic|Past-90-days at 3 months post-baseline||||Participants|||Count of Participants
1283381|NCT00227877|Primary|Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England|Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA|Past-12-months at 12 months post-baseline||||Participants|||Count of Participants
1283382|NCT00227877|Primary|Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA|Past-12-months at 12 months post-baseline||||Participants|||Count of Participants
1283383|NCT00227877|Primary|Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England|Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in New England, USA|Past-90-days at 3 months post-baseline||||Participants|||Count of Participants
1283384|NCT00227877|Primary|Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in New England, USA|Past-90-days at 3 months post-baseline|12-18 year old primary care patients who report past-12-month drug or alcohol use at baseline in New England, USA|||Participants|||Count of Participants
1283385|NCT00227760|Secondary|Progression Free Survival||Time from start of treatment to progression, death or last contact, or last tumor assessment before the start of further antitumor therapy, assessed up to 6.5 years|Total patients|||months||95% Confidence Interval|Median
1283386|NCT00227760|Primary|Objective Response, Evaluated Using RECIST|Partial response as assessed by RECIST criteria|4 weeks|Evaluable patients|||participants|||Number
1283387|NCT00227760|Primary|Incidence of Durable Stable Disease, Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)|Stable disease for a clinical benefit rate, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)|4 weeks|Evaluable patients|||particip[ants|||Number
1283388|NCT00227721|Secondary|Progression-free Survival||Every two cycles|||||||
1283389|NCT00227721|Primary|Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.||Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).||||percentage of participants with CR or PR||90% Confidence Interval|Number
1283390|NCT00227591|Primary|Overall Response Rate|"Response was evaluated for Anemia and Spleen:~Major anemia response: hemoglobin increase to within normal limits in the absence of transfusion. Minor anemia response: hemoglobin improvement of at least 2 grams per deciliter independent of transfusion support, or achievement of transfusion independence in transfusion-dependent patients. Major spleen response: normalization of spleen size to the range of 12-14 centimeters by ultrasound. Minor spleen response: a 50% or more decrease in excess spleen size by ultrasound. Complete remission (CR): complete resolution of disease-related symptoms, splenomegaly, normalization of peripheral blood count, white cell differential and smear, and normalization of bone marrow histology. Partial remission (PR): a major or minor response in anemia or splenomegaly. Overall Response (OR)=CR + PR, assessed among eligible, treated patients."|Assessed at the end of cycle 3|6 ineligible patients were excluded from the analysis.|||Proportion of participants||95% Confidence Interval|Number
1283391|NCT00227539|Secondary|Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate|The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|Up to 4 weeks after last dose of chemotherapy|One patient was excluded from the efficacy analysis because they were subsequently found to be ineligible. Three patients were unevaluable because they did not have have a CT scan after the completion of chemotherapy.|||Participants|||Count of Participants
1283392|NCT00227539|Secondary|Safety of Neoadjuvant Chemotherapy|The number of patients that experienced a grade 3 or higher adverse event.|Up to 4 weeks after last dose of chemotherapy||||Participants|||Count of Participants
1283393|NCT00227539|Primary|Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy|Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy|Between days 18 and 22 prior to second chemotherapy infusion|Only 19 patients had PET scans at both baseline and day 18-22 available for review.|||Participants|||Count of Participants
1283399|NCT00227370|Primary|Incidence of CMV Syndrome|CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)|over the course of 300 days after randomization|intention to treat analysis|||participants|||Number
1283400|NCT00227370|Primary|Incidence of CMV End Organ Disease|The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.|over the course of 300 days after randomization|Intention to treat analysis was conducted.|||participants|||Number
1283401|NCT00227344|Secondary|Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor||at each patients last follow-up visit|Intention to Treat (ITT)analysis of sinus rhythm was performed for subjects with available Holter Monitor data.|||percentage of participants|||Number
1283402|NCT00227344|Secondary|Health-economics Parameters (Days of Hospitalization)||at 26 months and at each patients last follow-up visit|Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.||||||
1283403|NCT00227344|Secondary|Quality of Life||at 14, 26 and 38 months|"Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The 0 below represents not available."||||||
1283404|NCT00227344|Secondary|Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs||at 26 months and at each patients last follow-up visit|"Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The 0 below represents not available."||||||
1283405|NCT00227344|Secondary|Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase||day 61 through 790|"Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data. The upper bound of the confidence interval for the drug treatment group could not be calculated because of the high censoring rate. Therefore, NA is more appropriate in place of the maximum duration of follow-up (790.0) as the upper bound."|||days||95% Confidence Interval|Median
1283406|NCT00227344|Secondary|Percentage of Procedural Success|"Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following:~“Has a validation of the lesions been performed by taking 3 points inside each circular lesion?”~“If YES to #1, did you observe that none of them exceed 0.1 mV?”~“Did you observe any adverse event during the procedure?”~If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success."|The day of the procedure|"Procedural success was only calculated for the catheter ablation group. Intention to Treat (ITT) analysis of procedural success for the catheter ablation group was performed using available data. The 0 below the Antiarrhythmic Drug treatment group represents not available."|||percentage of participants|||Number
1283407|NCT00227344|Secondary|Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)||within first 24 months after a 2-month run-in phase|Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.|||percentage of participants|||Number
1283408|NCT00227344|Primary|Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).|Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.|within first 24 months after a 2-month run-in phase|Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.|||percentage of participants|||Number
1283409|NCT00227305|Primary|Change From OL Baseline in Supine Diastolic BP.|Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)|OL baseline to Week 26|Number of participants with OL baseline and post treatment visits|||mmHg||Standard Deviation|Mean
1283410|NCT00227305|Primary|Change From OL Baseline in Supine Systolic BP.|Changes from OL baseline to the final visits in Supine systolic BP (mmHg)|OL baseline to Week 26|Number of participants with OL baseline and post treatment visits|||mmHg||Standard Deviation|Mean
1283411|NCT00227305|Primary|Change From Baseline in Supine Pulse|Change from OL baseline to week 26 in supine pulse (bpm)|OL baseline to week 26|Number of participants with OL baseline and post treatment visits|||bpm||Standard Deviation|Mean
1283412|NCT00227305|Primary|Change From Baseline in Weight|Number with 7% or more increase (without adjustment for normal growth)|26 weeks of treatment|Number of participants is based on patients with both baseline values and post-baseline values.|||Participants|||Number
1283413|NCT00227305|Primary|Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score|"Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.~Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score."|26 weeks of treatment|Number of patients with BARS score at OL baseline and week 26.|||Participants|||Number
1283414|NCT00227305|Primary|Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score|"Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).~Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score."|OL baseline to week 26|Number of patients with SAS score at OL baseline and week 26.|||Participants|||Number
1283551|NCT00224042|Secondary|Change in Serum Ferritin|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation|||ng/mL||Standard Deviation|Mean
1283415|NCT00227305|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS) Score|Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).|OL Baseline to Week 26|Number of patients with CGAS score at OL baseline and week 26.|||units on a scale||Standard Deviation|Mean
1283416|NCT00227305|Secondary|Changes in Tanner Stage|"Category shift in Tanner stage. Number of subjects who experienced the change is presented.~Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger."|Change from OL baseline to week 26 in the Tanner stage|Number of patients with Tanner stagging data at OL baseline and week 26 (final visit)|||Participants|||Number
1283417|NCT00227305|Primary|Changes in Laboratory Test Results (Prolactin)|"Clinical important shift to high prolactin from open-label (OL) baseline to week 26.~High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male."|Duration of study participation||||Participants|||Number
1283418|NCT00227305|Primary|Number of Patients Withdrawn Due to AEs.|Number of subjects who withdrew from the study due to AEs.|during 26 weeks of treatment||||Participants|||Number
1283419|NCT00227305|Primary|Incidence and Nature of Adverse Events (AEs)|Number of participants that had AE which occurred from first dose date to last dose date + 30 days.|from open label to week 26+ 30 days||||Participants|||Number
1283420|NCT00227266|Secondary|Max CMAP Area (Median)|The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)||||mVms||Full Range|Median
1283421|NCT00227266|Secondary|Max CMAP Area (Mean)|The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)||||mVms||Standard Deviation|Mean
1283422|NCT00227266|Secondary|DEXA||0, 6mo, 12mo|||||||
1283423|NCT00227266|Primary|Modified Hammersmith Change From Baseline to 6 Months|Comparison of Modified Hammersmith Change from baseline to 6 months. Scores range from 0 to 40. A higher score indicates a better outcome. This scale is used to assess gross motor abilities of non-ambulant children with SMA in multiple research trials as well as in clinical settings.|0 months, 6 months|Analysis only pertains to cohort 1a and 1b.|||Score||Standard Deviation|Mean
1283424|NCT00227266|Post-Hoc|Modified Hammersmith Extend Baseline|"Baseline Modified Hammersmith Extend testing. The baseline test is the score they receive during their screening visits. This scale ranges from 0 to 56. A higher score indicates a better outcome.~This scale is used to assess gross motor abilities of children with SMA in multiple research trials as well as in clinical settings."|1 month prior to enrollment, at enrollment (0 months)|Analysis was determined per protocol|||Score||Full Range|Mean
1283425|NCT00227266|Secondary|Nutritional Status||-4 wks, 0, 3mo, 6mo, 12mo|||||||
1283426|NCT00227266|Secondary|Growth and Vital Sign Parameters||-4 wks, 0, 3mo, 6mo, 12mo|||||||
1283427|NCT00227266|Secondary|Ulnar MUNE||-4 wks, 0, 3 mo, 6 mo, 12 mo|||||||
1283428|NCT00227266|Secondary|Max CMAP Amplitude Median|The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)||||mV||Full Range|Median
1283429|NCT00227266|Secondary|Max CMAP Amplitude (Mean)|The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)||||mV||Standard Deviation|Mean
1283430|NCT00227266|Secondary|Peds QL™ Assessment: Parental Version (All), Child Versions (> 5yrs)||-4wks, 0, 3mo, 6mo, 12mo|||||||
1283431|NCT00227266|Secondary|Quantitative Assessment of SMN mRNA From Blood Samples||-4wks or 0, 3 mo, 6 mo, 12 mo|||||||
1283432|NCT00227266|Primary|Efficacy, Measured Through Motor Function Assessments||-4wks, 0, 3 mo, 6 mo, 12 mo|||||||
1283433|NCT00227266|Primary|Safety Labs|Participants will have labs drawn regularly to maintain appropriate dosing and monitor liver function|-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs|||||||
1283434|NCT00227019|Secondary|Overall Survival (OS)|"Overall Survival (OS) is defined as the duration of time from start of treatment to deat.~Kaplan-Meier survival curves for OS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL)."|18 months||||months||95% Confidence Interval|Median
1283435|NCT00227019|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of documented disease progression or death.~Kaplan-Meier survival curves for PFS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL)."|18 months||||months||95% Confidence Interval|Median
1283436|NCT00227019|Primary|Incidence of Central Nervous System (CNS) Hemorrhagic Events|Number of events of brain or central nervous system (CNS) bleeding|18 months|All participants in this study are included in the analysis population|||CNS hemorrhagic events|||Number
1284069|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
1283437|NCT00226941|Secondary|Survival at 5 Years|Survival at 5 years was assessed as the number of participants alive 5 years after starting treatment.|5 years|This outcome is defined per protocol as study phase 2, which did not occur. However, data are available from the phase 1 participants (only), and are provided for completeness. This study was terminated before all patients reached 5 years from study entry. Only patients known to be alive at 5 years are reported.|||Participants|||Count of Participants
1283438|NCT00226941|Secondary|Overall Survival (OS)|Overall Survival (OS) was assessed as the mean survival from the date of entry on study though 72 months.|72 months|This outcome is defined per protocol as study phase 2, which did not occur. However, data are provided for phase 1 participants, for completeness. This study was terminated before all patients reached 5 years on study. Some patients are reported as the last known alive date.|||months||Standard Deviation|Mean
1283439|NCT00226941|Secondary|Time-to-Progression (TTP)|Time-to-progression was assessed as the time from the date of surgical resection to the appearance of either local disease recurrence or distant metastases by any modality (eg, clinical exam, endoscopy, radiographic imaging). All relapses were to be confirmed by biopsy and pathology review.|5 years|This study was terminated before all patients reached 5 years from the date of surgical resection. Only patients that progressed are reported, and since no patients progressed in Group 2, median and range are not reportable.|||years||Full Range|Median
1283440|NCT00226941|Secondary|Tumor Downstaging at Surgical Resection|Downstaging means a reduction from the stage of disease observed at baseline to the stage of disease after treatment with cetuximab, radiotherapy, oxaliplatin, and capecitabine, as determined at the time of surgical removal of the tumor. Downstaging may be observed as improvements in tumor staging at the primary site of the tumor; in nearby (regional) lymph nodes; or in metastatic disease beyond the regional lymph nodes. This outcome specifically does not include participants that achieved a complete response, nor those that experienced no response or disease progression.|12 to 14 weeks after radiotherapy|This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness.|||Participants|||Count of Participants
1283441|NCT00226941|Secondary|Pathologic Response Rate|After treatment with capecitabine, cetuximab, radiotherapy, and oxaliplatin, the pathologic response rate was assessed based on the excised tumor taken at the time of surgical resection. Pathologic response rate was determined as the number and proportion of participants who experienced either downstaging of their disease, or complete response (CR, no detectable disease). A participant will be considered to have downstaging of the tumor as a result of the neoadjuvant therapy when the primary tumor (T) stage by pathology isless than the T stage by clinical (endoscopic) evaluation, or when the regional lymph node (N) tumor stage by pathology is less than the N stage by clinical (endoscopic) evaluation.|12 to 14 weeks after radiotherapy|This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness.|||Participants|||Count of Participants
1283442|NCT00226941|Primary|Dose-limiting Toxicity (DLT) - Number of Participants Affected|Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of participants experiencing a DLT.|10 weeks|All participants were formally part of the phase 1 portion of this study.|||Participants|||Count of Participants
1283443|NCT00226941|Primary|Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group|Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group.|10 weeks|All participants were formally part of the phase 1 portion of this study.|||DLTs|||Number
1283444|NCT00226811|Primary|Objective Response (Complete Response (CR) or Partial Response (PR))|Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT population|||participants|||Number
1283445|NCT00226811|Secondary|Overall Survival|Time from the date of first dose of study medication to the date of death due to any cause. OS was calculated as (date of death minus the date of first dose date plus 1) divided by 7.|From start of study treatment until death|ITT population|||weeks||95% Confidence Interval|Median
1283446|NCT00226811|Secondary|Time to Tumor Progression (TTP)|Time from the start of study treatment to the first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose plus 1) divided by 7.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT population|||weeks||95% Confidence Interval|Median
1283447|NCT00226811|Secondary|Progression-Free Survival|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause. PFS was calculated as (first event date minus the date of first dose plus 1) divided by 7.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT population|||weeks||95% Confidence Interval|Median
1283448|NCT00226811|Secondary|Duration of Response (CR or PR)|Time from the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression or to death due to any cause. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer|ITT population|||weeks||Full Range|Mean
1283463|NCT00226239|Secondary|3-year Overall Survival (OS)|Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.|Up to 36 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.|||percentage of participants||95% Confidence Interval|Number
1288792|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg|24-hour fed Leptin dose 0.01 mg/kg|1 DAY||||NG/ML||Standard Deviation|Mean
1283449|NCT00226811|Secondary|Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks|Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR or stable disease (SD) for at least 24 weeks on study according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progessive disease (PD) taking as a reference the smallest sum of the longest dimensions since the treatment started.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study|ITT population|||participants|||Number
1283450|NCT00226811|Primary|Best Overall Response|Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|Intent-to-treat (ITT) population includes all patients enrolled in the study that received at least 1 dose of study medication.|||participants|||Number
1283451|NCT00226655|Primary|Long Term Safety and Tolerability of hCRF|Number of patients reporting adverse events|Prospective|Intent to Treat|||Participants|||Number
1283452|NCT00226590|Secondary|Treatment Completion|The number of participants who completed all treatment on schedule without dose reductions or delays.|Ranging from 2 weeks up to 4 years, 9 months|per protocol|||participants|||Number
1283453|NCT00226590|Secondary|Overall Survival|To determine median Overall Survival rate|Ranging from 2 weeks up to 4 years, 9 months||||months||95% Confidence Interval|Median
1283454|NCT00226590|Secondary|Progression Free Survival|To determine median Progression Free Survival rate. Progression-free survival (PFS) is defined as the interval between the date of the first chemotherapy administration and the date of objective progression or death. Progression was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Ranging from 2 weeks up to 4 years, 9 months|per protocol|||months||95% Confidence Interval|Median
1283455|NCT00226590|Primary|Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation|Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Ranging from 2 weeks up to 4 years, 9 months|Per Protocol|||participants|||Number
1283456|NCT00226577|Secondary|Toxicity|Number of participants with toxicity ≥ Grade 3 after gemcitabine plus pemetrexed induction chemotherapy.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A total of 52 eligible patients, 26 men and 26 women, between the ages of 41 and 83 years received at least one dose of chemotherapy. Only 49 patients were evaluable because 3 patients had only the first cycle.|||participants|||Number
1283457|NCT00226577|Secondary|Survival - Overall|Median range of number of participants with Overall Survival. Overall survival (OS) will be defined as the period of time from the first day of drug treatment to the date of death of the patient. Patients taken off study will be followed quarterly until death for survival data.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|All patients|||months||Full Range|Median
1283458|NCT00226577|Secondary|Survival - Disease Free|Disease-free survival (DFS) is defined as the period of time from surgery to the time when disease recurrence is clearly documented. A histologic confirmation is required in equivalent cases.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|40 patients with complete tumor resection.|||months||Full Range|Median
1283459|NCT00226577|Secondary|Disease Response - Pathologic|Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen, which consists of equal to or more than 95% fibrosis and necrosis.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A pathologic response evaluation was possible in 43 of 52 patients.|||participants|||Number
1283460|NCT00226577|Primary|Disease Response - Radiographic|"Number of participants with partial or Complete Response. Complete response (CR) is defined as the total disappearance of all malignant and evaluable clinical evidence of cancer without the development of any new malignant lesions documented on the post chemotherapy chest CT and PET scan.~Partial response (PR) (measurable disease only): When compared with pre-treatment measurements, a reduction of >30% in the sum of the largest diameters of all measurable lesions and absence of new lesions."|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A radiographic response evaluation was possible in 49 of 52 patients.|||participants|||Number
1283461|NCT00226239|Other Pre-specified|EGFR-related Serum Markers|Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.|Up to 36 months|||||||
1283462|NCT00226239|Secondary|Quality of Life (QOL)|"Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy–General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale. The instructions to the participant were: Below is a list of statements that other people with your illness have said are important. By circling one number per line, please indicate how true each statement has been for you during the past 7 days. The choices for each statement ranged from 0 (not at all) to 4 (very much). The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being. Questions for both assessments are phrased so that higher numbers/values indicate a better health state."|Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE|Analysis was completed using all responses actually obtained.|||units on a scale||Standard Deviation|Mean
1283495|NCT00225212|Secondary|Overall Survival (OS)||24 months||||percentage of subjects remaining alive||95% Confidence Interval|Number
1283496|NCT00225212|Primary|Event-free Survival (EFS)|"Events for EFS were defined as the earlier of post-ASCT relapse or death."|24 months||||percentage of not experiencing EFS event||95% Confidence Interval|Number
1283464|NCT00226239|Secondary|2-year Overall Survival (OS)|Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.|Up to 24 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.|||percentage of participants||95% Confidence Interval|Number
1283465|NCT00226239|Secondary|Progression-free Survival (PFS)|PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0. The two-year and three-year PFS ended up being the same in this study.|Up to 36 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.|||percentage of participants||95% Confidence Interval|Number
1283466|NCT00226239|Secondary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.|Up to 36 months|Docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE).|||percentage of participants||95% Confidence Interval|Number
1283467|NCT00226239|Primary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.|Up to 36 months|Treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles.|||percentage of participants||95% Confidence Interval|Number
1283468|NCT00225784|Secondary|Pattern of Failure After Therapy|Local recurrence, distant recurrence, or both.|Five years post treatment|All participants who completed treatment and underwent resection|||participants|||Number
1283469|NCT00225784|Secondary|Overall Length of Survival After Therapy|Length of survival after therapy in all participants enrolled.|Five years post treatment|All participants enrolled regardless of evaluability for primary outcome measure.|||months||Full Range|Median
1283470|NCT00225784|Secondary|Disease-Free Survival After Therapy|Time to disease progression after therapy.|Five years post treatment|All evaluable participants who completed treatment, and had confirmed progression of disease.|||months||Full Range|Median
1283471|NCT00225784|Secondary|Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.|Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.|One month post-therapy|All EGFR (-) subjects who completed therapy were evaluated.|||percent|||Number
1283472|NCT00225784|Secondary|Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy|Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).|1 month after completion of treatment|Surviving participants who completed therapy and were determined to be resectable.|||participants|||Number
1283473|NCT00225784|Secondary|Number of Participants Assessed for Adverse Events|Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0|Participants were followed during treatment and for 30 days after completion of treatment|All participants were evaluated for toxicity.|||participants|||Number
1283474|NCT00225784|Primary|Objective Response of Tumor by RECIST 1.0 Criteria|Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.|one month post-therapy|Completion of treatment|||participants|||Number
1283475|NCT00225758|Secondary|Determine Whether Changes in Plasma DNA Concentrations Are Predictive Markers of an Early Response to Lapatinib||14 weeks|Plasma DNA assays were not done due to difficulty obtaining plasma specimens from the outside sites, and technical problems with the assay in the specimens collected at our institution..||||||
1283476|NCT00225758|Secondary|Determine Changes in Activation of Tumor Cell ERK and Akt, as Between the Hormonal Agent and Lapatinib Contributes to the Molecular Pharmacodynamic Effect Postulated Above.||4 weeks|None of the patients had the recommended biopsies done as the biopsies were optional, and over half the patients had either bone-only disease or only non-biopsiable soft tissue disease.||||||
1283477|NCT00225758|Secondary|Determine the Toxicities of the Combination of the Hormonal Agent and Lapatinib in Patients With Metastatic Breast Cancer||26 weeks|All 27 subjects are evaluable for toxicity|||Participants|||Count of Participants
1283478|NCT00225758|Primary|Progression-free Survival|Progression-free survival is the time between date on study and progression based on RECIST criteria.|Up to 575 days||||days||Inter-Quartile Range|Median
1283479|NCT00225758|Primary|Determine the Response Rate and Progression Free Survival of Hormone Therapy-resistant Patients With Metastatic Breast Cancer Treated With the Same Continued Hormonal Agent With the Addition of Lapatinib.|A response is defined as stable disease or better at 26 weeks. Twenty two patients are evaluable for response|26 weeks|Of the 27 enrolled subjects, five subjects came off study due to toxicity prior to week 14, at the time of the first restaging. The remaining 22 subjects are evaluable for response.|||Participants|||Count of Participants
1283480|NCT00225732|Primary|Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery|Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery|24 Hours||||milligrams||Standard Error|Least Squares Mean
1283548|NCT00224107|Primary|International Prostate Symptom Score (IPSS)|Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||Units on a 0 to 35 scale||Standard Deviation|Mean
1283481|NCT00225498|Primary|Working Memory|"California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome.~The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner."|3 months|The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.|||units on a scale||Standard Deviation|Mean
1283482|NCT00225420|Secondary|Biochemical Progression-free Survival (PFS)|Measure of the activity of a treatment on a disease. In this study it is measured from the date of enrollment to the date on which the prostate cancer progresses or the date the patient dies. Survival curves were estimated using the Kaplan-Meier technique. Biochemical (PSA) failure is defined, in accordance to the American Society for Therapeutic Radiology and Oncology consensus definition, as three consecutive rise in PSA. The date of biochemical failure is considered to be the midpoint between the last non-rising PSA and the first rising PSA.|Average follow up of 2 years||||percentage of patients||95% Confidence Interval|Mean
1283483|NCT00225420|Primary|Number of Patients Experiencing Dose-Limiting Toxicities|Determine the number of patients experiencing dose-limiting toxicities (DLT) at each dose level. DLT was defined as grade 3-4 non-haematological or grade 4 haematological toxicity, using the Common Terminology Criteria for Adverse Events, version 3.0.|Average follow up of 2 years||||Participants|||Count of Participants
1283484|NCT00225277|Other Pre-specified|Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee|The incidence of cardiovascular events and composite endpoints occurring within 30 days of last dose as adjudicated by the Clinical Endpoint Committee. Abbreviations: PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft; CHF: Congestive Heart Failure.|Up to 72 weeks|Safety Population|||Number of Events|||Number
1283485|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint C cardiovascular events is being reported instead of time to first occurrence. Endpoint C conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.|||participants|||Number
1283486|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint B cardiovascular events is being reported instead of time to first occurrence. Endpoint B conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.|||Participants|||Number
1283487|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint A cardiovascular events is being reported instead of time to first occurrence. Endpoint A conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.|||Participants|||Number
1283488|NCT00225277|Secondary|Nominal Change From Baseline in Normalized Total Atheroma Volume|The nominal change in normalized total atheroma volume as measured by the average of plaque areas for all slices of anatomically comparable segments of the target coronary artery multiplied by the mean number of matched slices in the population. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.|Baseline and Final Visit (up to 72 weeks)|N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.|||Percent volume||Standard Error|Least Squares Mean
1283489|NCT00225277|Primary|Nominal Change From Baseline in Percent Atheroma Volume|The nominal change from baseline in percent atheroma volume for all slices of anatomically comparable segments of the target coronary artery. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.|Baseline and Final Visit (up to 72 weeks)|N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.|||Percent volume||Standard Error|Least Squares Mean
1283490|NCT00225251|Secondary|Global Assessment of Functioning Scale (GAFS)|A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)|10 weeks||||units on a scale||Standard Deviation|Mean
1283491|NCT00225251|Secondary|Clinical Global Improvement (CGI)|A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)|10 weeks||||units on a scale||Standard Deviation|Mean
1283492|NCT00225251|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|10 weeks||||units on a scale||Standard Deviation|Mean
1283493|NCT00225251|Secondary|Cornell Dysthymia Rating Scale (CDRS)|A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression|10 weeks||||units on a scale||Standard Deviation|Mean
1283494|NCT00225251|Primary|Hamilton Depression Rating Scale, 24 Items (HDRS)|"Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.~This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)"|10 weeks||||units on a scale||Standard Deviation|Mean
1283497|NCT00225147|Secondary|Time to Minimal Symptoms|"The time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale (VAS) score. Symptoms were said to be minimal when the VAS score at all locations was below 20 mm. Assessment timepoints were: baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to minimal symtoms has been calculated by using the exact timepoints on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."|||minutes||Full Range|Median
1283498|NCT00225147|Primary|Time to Beginning of Relief of Symptoms|"The time to beginning of relief of symptoms at the location that showed the first visual analogue scale (VAS) score decrease of at least 20 mm from baseline score with persistence to the next timepoint, assessment timepoints were taken on pre-scheduled time-points after study drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to beginning of relief has been calculated as median time, by using the exact timepoints on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."|||minutes||Full Range|Median
1283499|NCT00225017|Secondary|Changes in LDL Particle Number From Baseline to Week 24|Change in LDL particle number|Baseline to 24 weeks||||nmol/l||Inter-Quartile Range|Median
1283500|NCT00225017|Secondary|Change in Total Cholesterol Levels From Baseline to Week 24|Total cholesterol level changes within and between arms|Baseline to 24 weeks||||mg/dL||Inter-Quartile Range|Median
1283501|NCT00225017|Primary|Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24|Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen|Baseline to week 24||||percentage change||Inter-Quartile Range|Median
1283502|NCT00224952|Secondary|Age-related Changes in Bioactivation|2. To determine if age-related differences exist regarding the ability of pediatric patients to bioactivate carbamazepine or valproate to reactive metabolites. Data provided below reflect the slope of the least squares regression.|urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years|Change in Carbamazepine detoxification as a function of age is determined only in patients in the Carbamazepine Phase 2 arm. Changes in Valproic Acid detoxification as a function of age are determined only in patients in the Valproic Acid Phase 2 arm.|||years^(-1)|||Number
1283503|NCT00224952|Primary|Drug (Valproic Acid or Carbamazepine) Metabolite Profiles in Urine|1. To examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine the identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species (e.g., through conjugation with detoxifying compounds such as glutathione).|urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years|Carbamazepine detoxification product (MTHIS) was only measured in the Carbamazepine Phase I and 2 arms. Valproic Acid (NAC) detoxification products were only measured in the Valproic Acid Phase 2 arm. Units of measure for all analytes are nmol per mg creatinine.|||nmol per mg creatinine||Standard Deviation|Mean
1283504|NCT00224874|Secondary|Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma||Measured at 9 months|No data collected||||||
1283505|NCT00224874|Secondary|Cumulative Incidence of Systemic Infections||Measured at Day 270||||percentage of participants||95% Confidence Interval|Number
1283506|NCT00224874|Secondary|Number of Patients Surviving at 6 and 9 Months Post Randomization||Measured at 6 and 9 months|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
1283507|NCT00224874|Secondary|Number of Patients With Chronic Graft-versus-host Disease (GVHD)|Number of patients with limited and extensive chronic GVHD at 9 months|Measured at 9 months|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
1283508|NCT00224874|Secondary|Number of Patients Discontinuing Immune Suppression Without Flare|Immunosuppression discontinuation was defined as the discontinuation of corticosteroids and all additional immunosuppressives, except cyclosporine or tacrolimus, for treatment of acute GVHD without subsequent flare by Day 90 post-initiation of therapy and later by discontinuation of all immunosuppressive medications, including cyclosporine or tacrolimus.|Measured at Days 90, 180, and 270 post-treatment|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
1283509|NCT00224874|Secondary|Number of Patients With Acute Graft-versus-host Disease (GVHD) Flares at Day 90|Flares were defined as any increase in symptoms of or therapy for acute GVHD after an initial response (i.e., progression from an earlier CR or PR).|Measured at Day 90|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
1283510|NCT00224874|Secondary|Proportion of Treatment Failure||Measured at Day 56||||percentage of participants||95% Confidence Interval|Number
1283511|NCT00224874|Secondary|Number of Partial Response (PR), Mixed Response (MR), and Progression|Partial response, mixed response, and progression at Day 28 after randomization. Partial response was defined as improvement in one or more organs involved with Graft-Versus-Host Disease (GVHD) symptoms without progression in others. Mixed response was defined as improvement in one or more organs with deterioration in another organ manifesting symptoms of GVHD or development of symptoms of GVHD in a new organ. Progression was defined as deterioration in at least one organ without any improvement in others.|Measured at Day 28|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
1283512|NCT00224874|Primary|Number of Complete Response (CR) at Day 28 of Therapy|Complete response at day 28 after randomization. CR was defined as resolution of all signs and symptoms of Graft-Versus-Host Disease (GVHD) in all evaluable organs in comparison to Day 1 scoring.|Measured at Day 28|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
1285286|NCT00193258|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease||18 months|All patients enrolled in the trial|||months||95% Confidence Interval|Median
1283513|NCT00224770|Primary|Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180|Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead|180 days from randomization||||percentage of participants||90% Confidence Interval|Number
1283514|NCT00224770|Secondary|Post-operative Clot Size Reduction|The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients.|Time from post-operation until end of treatment, up to 10 days|Analysis population only includes surgical patients.|||percentage of blood clot resolved||Inter-Quartile Range|Median
1283515|NCT00224770|Secondary|Clot Size Reduction by End of Treatment|The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan.|Time from randomization until end of treatment, up to 10 days||||percentage of blood clot resolved||Inter-Quartile Range|Median
1283516|NCT00224770|Secondary|Ordinal Modified Rankin Scale (mRS) at Day 365|Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.|365 days from randomization||||units on a scale||Inter-Quartile Range|Median
1283517|NCT00224770|Secondary|Ordinal Modified Rankin Scale (mRS) at Day 180|Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.|180 days from randomization||||units on a scale||Inter-Quartile Range|Median
1283518|NCT00224770|Primary|Safety Outcome Number 4: Rate of Symptomatic Rebleeding|The difference in the rate of symptomatic rebleeding 72 hours post last dose.|72 hours post last dose||||percentage of participants||90% Confidence Interval|Number
1283519|NCT00224770|Primary|Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis|Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.|30 days from randomization||||percentage of participants||90% Confidence Interval|Number
1283520|NCT00224770|Primary|Safety Outcome Number 2: Rate of Procedure-related Mortality|Percentage of participants who died during the first 7 days after randomization.|7 days from randomization||||percentage of participants||90% Confidence Interval|Number
1283521|NCT00224770|Primary|Safety Outcome Number 1: Rate of Mortality|Percentage of participants who died during the first 30 days after randomization.|30 days from randomization||||percentage of participants||90% Confidence Interval|Number
1283522|NCT00224484|Secondary|Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations|"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL).~The subset of subjects used for this analysis was 50% of the pre-defined subset of subjects that underwent assessment of biochemical and hematological parameters."|At months 0, 7 and 12|The analyses were performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects included in the immunogenicity subset for whom data concerning immunogenicity outcome measures were available (for whom assay results were available for antibodies against the study vaccine antigen component after Vaccination).|||EU/mL||95% Confidence Interval|Geometric Mean
1283523|NCT00224484|Secondary|Anti-glycoprotein D (Anti-gD) Antibody Concentrations|"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL).~Analysis was based on an immunogenicity subset, stratified by initial serostatus: HSV seronegative (-)/ seropositive (+), this included gD2-AS04 vaccine recipients, as follows: HSV 1 and HSV 2 seronegative (HSV1-/2-) and HSV 1 seropositive and HSV 2 seronegative (HSV1+/2-)"|At months 0, 7 and 12|The analyses were performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects included in the immunogenicity subset for whom data concerning immunogenicity outcome measures were available (for whom assay results were available for antibodies against the study vaccine antigen component after Vaccination).|||EU/mL||95% Confidence Interval|Mean
1283524|NCT00224484|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled."|Up to month 18 (during active phase and ESFU period)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283525|NCT00224484|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.|During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283526|NCT00224484|Secondary|Number of Subjects With Medically Significant Conditions (MSC)|"MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled."|During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283527|NCT00224484|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.|Starting from Day 30 until the end of study (Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283528|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents WBC results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283529|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents UREA results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283530|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents RBC results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283531|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents PLA results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283532|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents Hct results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283533|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents CREA results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283549|NCT00224055|Secondary|Change in Serum Ferritin|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation|||ng/mL||Standard Deviation|Mean
1283534|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents ALT results.|At months 0, 7 and 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283535|NCT00224484|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|During the active phase (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283536|NCT00224484|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.|Within the 30 Day (Day 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283537|NCT00224484|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. In adults/ adolescents, such an AE would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy. Related = event assessed by the investigator as causally related to study vaccination.|Within 30 days (Day 0-29) after any vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283538|NCT00224484|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, malaise, rash, temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 arthralgia, fatigue, headache, malaise, rash = general symptom that prevented normal activity. Grade 3 temperature = greater than 39 degrees Celsius (°C). Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = general symptom assessed by the investigator as causally related to the study vaccination.|Within 7 days (Days 0-6) after each and any vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283539|NCT00224484|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = greater than (>) 30mm diameter and persisting more than 24 hours.|Within 7 days (Days 0-6) after each and any vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.were|||Subjects|||Number
1283540|NCT00224484|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Subjects|||Number
1283541|NCT00224289|Primary|Post-Treatment IOP (Intraocular Pressure)|Subjects applied topical latanoprost at bedtime for 8 weeks|8 Weeks||||mm Hg||Standard Deviation|Mean
1283542|NCT00224289|Primary|Pre-Treatment IOP (Intraocular Pressure)|Subjects applied topical latanoprost at bedtime for 8 weeks|At baseline (before treatment)||||mm Hg||Standard Deviation|Mean
1283543|NCT00224133|Secondary|International Prostate Symptom Score (IPSS)|The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.|9 months||2010-03-31|03/2010||||
1283544|NCT00224133|Primary|Adverse Events|All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.|9 months|Safety population was analyzed. This population is defined as all enrolled patients who received at least one dose of study drug.|||participants|||Number
1283545|NCT00224120|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks||Baseline and 12 weeks||||mL/min||Standard Deviation|Mean
1283546|NCT00224120|Primary|Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms|Baseline and 12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1283547|NCT00224107|Secondary|Maximum Urine Flow Rate (Qmax)|Change from baseline in maximum urine flow rate (Qmax)at Week 12|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||mL/sec||Standard Deviation|Mean
1288793|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg|24-hour fed Leptin dose 0.01 mg/kg|1 DAY||||HR||Standard Deviation|Mean
1283552|NCT00224042|Primary|Change in Hemoglobin (Hgb)|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation|||g/dL||Standard Deviation|Mean
1283553|NCT00224042|Secondary|Baseline Serum Ferritin Concentration||Baseline||||ng/mL||Standard Deviation|Mean
1283554|NCT00224042|Primary|Baseline Hemoglobin Concentration||Baseline||||g/dL||Standard Deviation|Mean
1283555|NCT00224029|Secondary|Urinary Leakage and Catheterization Data||8 weeks|||||||
1283556|NCT00224029|Secondary|Urodynamic Measurements||8 weeks|||||||
1283557|NCT00224029|Secondary|Patch Adhesion||8 weeks|||||||
1283558|NCT00224029|Primary|Average Number of Catheterizations Without Leaking Per Day|Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.|8 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF.|||Number of Dry Catheterizations per Day||Standard Deviation|Mean
1283559|NCT00224016|Secondary|Urine Volume After First Awakening|Change from baseline in average volume of urine collected after first morning awakening|14 weeks|||||||
1283560|NCT00224016|Secondary|Catheterizations Without Leakage|Percentage of catherizations without leakage|14 weeks|mITT, LOCF|||% of participants||Standard Deviation|Mean
1283561|NCT00224016|Primary|Average Catheterization Urine Volume|Change from baseline in average volume of urine collected by catheterization|14 weeks|Modified intent-to-treat (mITT) population, Last Observation Carried Forward (LOCF) imputation|||mL||Standard Deviation|Mean
1283562|NCT00224003|Primary|Transferrin Saturation|Change from baseline to 2 weeks after last dose|14 weeks|Per protocol (completer) population|||%||Standard Deviation|Mean
1283563|NCT00224003|Secondary|Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.||14 weeks|||||||
1283564|NCT00224003|Primary|Serum Ferritin|Change from baseline to 2 weeks after last Fe dose|14 weeks|Per protocol (completer) population|||ng/mL||Standard Deviation|Mean
1283565|NCT00223977|Secondary|Responders by Treatment Group|Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.|Baseline to 5 weeks and 9 weeks||||participants|||Number
1283566|NCT00223977|Secondary|Change From Baseline in Serum Ferritin.|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks||||ng/mL||Standard Deviation|Mean
1283567|NCT00223977|Secondary|Change From Baseline in Transferrin Saturation (TSAT).|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks||||percent||Standard Deviation|Mean
1283568|NCT00223977|Secondary|Change From Baseline in Hematocrit (Hct)|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks||||percent||Standard Deviation|Mean
1283569|NCT00223977|Primary|Hemoglobin|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|modified intent to treat (mITT) with last observation carried forward (LOCF) imputation|||ng/mL||Standard Deviation|Mean
1283570|NCT00223821|Secondary|Change in Incontinent Episodes at 12-month Follow-up|Percent change from baseline in weekly frequency of incontinent episodes at 12-months post-treatment, derived from baseline and 12-month seven-day bladder diaries|Baseline and 12 months post-treatment|Intention to treat|||percent change||Standard Deviation|Mean
1283571|NCT00223821|Primary|Change in Incontinent Episodes Immediately Post-treatment|Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.|Baseline and immediately post-treatment - week 8|Intention to treat|||percentage change||Standard Deviation|Mean
1283572|NCT00223808|Secondary|Change in FIM Score at 6-months|Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63|Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.|A total of 37 subjects returned for the 6-month follow-up evaluations.|||units on a scale||Standard Error|Mean
1283573|NCT00223808|Secondary|Change in FIM Score Immediately Following Study Intervention.|Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL). The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL. It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task). Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63). A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.|After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.||||units on a scale||Standard Error|Mean
1283574|NCT00223808|Primary|Fugl-Meyer Score Change at 6 Months|Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.|FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.|A total of 37 subjects returned for the 6-month follow-up evaluations.|||units on a scale||Standard Error|Mean
1283587|NCT00223665|Secondary|Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IAS|Verbal Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT via the Proactive Interference (PI) task. The PI task involves participants listening to a list of 10 words from the same semantic category (e.g., articles of clothing), and then recalling as many of these words as possible.The procedure is repeated for a total of 4 trials. Assessment is based on the total number of words recalled.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||Number of correctly recalled words||Standard Deviation|Mean
1283575|NCT00223808|Primary|Fugl-Meyer Score Change Immediately Following Study Intervention.|Change in Fugl-Meyer Assessment (FMA) score. The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score. It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke. Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain. Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully. Subscales can be administered without the using the full test. For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66. A greater increase in the score represents a greater improvement in upper limb motor function.|After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.||||units on a scale||Standard Error|Mean
1283576|NCT00223795|Primary|Peak Vertical Force on Affected Limb|An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months).|Baseline and end of first intervention period (2 months)||||N/kg||Standard Deviation|Mean
1283577|NCT00223704|Secondary|Fibrinolytic Response as Measured by D-dimer|D-dimer concentrations were measured at baseline, 30min and 60min of bypass, post-bypass and postoperative day 1|Patients were followed from the start of surgery until postoperative day 1||||ng/ml||Standard Error|Mean
1283578|NCT00223704|Secondary|Inflammatory Response as Measured by Interleukin-6|Interleukin-6 was measured at baseline, post-bypass and on postoperative day 1 and 2.|Patients were followed from the start of surgery until postoperative day 2||||pg/ml||Standard Error|Mean
1283579|NCT00223704|Secondary|Units of Plasma Transfused During Hospitalization|Units of plasma transfused|Patients were followed for the duration of hospital stay, an average of 6 days||||units||Standard Error|Mean
1283580|NCT00223704|Secondary|Units of Packed Red Blood Cells Transfused During Hospitalization|Units of Packed Red Blood Cells Transfused|Patients were followed for the duration of hospital stay, an average of 6 days||||units||Standard Error|Mean
1283581|NCT00223704|Primary|Allogenic Blood Product Transfusion Risk|Blood product transfusion during hospitalization that included packed red blood cells, plasma, platelets and cryoprecipitate.|Patients were followed for the duration of hospital stay, an average of 6 days||||percentage of participants|||Number
1283582|NCT00223678|Primary|Graft Survival||3 years||||participants||95% Confidence Interval|Median
1283583|NCT00223665|Secondary|Score on Verbal Ability/Fluency Testing During First Cycle of IAS|Verbal Ability/Fluency was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. Participants were asked to verbally generate as many words beginning with a particular letter (e.g. P) within a 60 second period. Two trials were administered with two different letters. The total number of words generated was recorded for each letter and summed and analyzed.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||Number of words generated||Standard Deviation|Mean
1283584|NCT00223665|Secondary|Score on Spatial Memory Testing During First Cycle of IAS|Spatial Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT using the Puget Sound Route Learning Test. This test measured the ability to navigate a short route within a room. Three trials were administered followed by three trials of a new route using pictures placed on the floor as landmarks. A delayed recall is administered after twenty minutes. Performance was assessed based on number of correctly recalled sequences after a delay.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||number of correctly recalled sequences||Standard Deviation|Mean
1283585|NCT00223665|Secondary|Score on Verbal Memory Testing (Story Recall) During First Cycle of IAS|Verbal Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT via Story Recall. This task is based on the well known Wechsler Memory Scale –Revised Logical Memory task. Participants listened to two brief narratives (stories) and were asked to recall as much as possible immediately after hearing each story and following a 20-minute delay. Assessment was based on number of correctly recalled pieces of information after a delay.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||number of correctly recalled data points||Standard Deviation|Mean
1283586|NCT00223665|Secondary|Score on Visual Working Memory Test During First Cycle of IAS|Visual Working Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This task is based on the Subject Ordered Pointing Task (SOPT). The participant is shown a grid array of 10, 12 or 16 abstract designs and they must choose a new design with each refresh of the screen. Assessment is based on total number of errors.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||total number of errors||Standard Deviation|Mean
1283620|NCT00222105|Secondary|Toxicity|Count of Participants with adverse events.|End of study, up to 12 months||||Participants|||Count of Participants
1283766|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 26|Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).|26 weeks|Intent to treat|||percentage of randomized|||Number
1283588|NCT00223665|Secondary|Score on Executive Function Testing (Stroop Task) During First Cycle of IAS|Executive Function was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Stroop Color Word Interference Task. Subjects are asked to read 100 color words (red, green, blue), followed by identification of color blocks followed by reading the color of the ink and ignoring the word (e.g., the word ‘blue’ printed in green letters). Assessment was based on the amount of time needed to time to complete the assessment.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||minutes to complete the assessment||Standard Deviation|Mean
1283589|NCT00223665|Secondary|Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS|Spatial Ability (Mental Rotation) was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Vandenberg & Kuse (1978) Mental Rotation Test. Subjects are presented with line drawings of complex, three dimensional cubes on a computer screen. The subject must compare the two drawings and decide if they match. Score is based on number of correctly identified figures.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||Number of correctly identified figures||Standard Deviation|Mean
1283590|NCT00223665|Secondary|Score on Spatial Ability Test (Block Design) During First Cycle of IAS|Spatial Ability was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Wechsler Adult Intelligence Scale-Revised, Block Design sub-test and measures participants’ ability to analyze and construct abstract figures from their component parts. The test allows a time limit of 3 minutes per design, for a total of nine designs. Score is based on total number of designs completed (max 9, min 0).|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||Number of correctly completed designs||Standard Deviation|Mean
1283591|NCT00223665|Secondary|Estradiol Levels During First Cycle of IAS|Estradiol was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having estradiol measurements at each of the listed time points.|||pg/ml||Standard Deviation|Mean
1283592|NCT00223665|Secondary|Testosterone Levels During IAS|Testosterone was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having testosterone measurements at each of the listed time points.|||ng/ml||Standard Deviation|Mean
1283593|NCT00223665|Secondary|Development of Osteopenia (Bone Loss) During IAS|Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm^2 as a indicator of bone health for each patient at each time point. This measure was defined as the percentage of participants with normal BMD scores at baseline who developed Osteopenia after the first cycle of ADT.|From screening prior to first dose of ADT through the start of the second cycle of ADT.|38 subjects were evaluable for this outcome measure, defined as meeting all of the following: having completed first cycle of ADT (9 months); no prior or concurrent use of bisphosphonates; a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2; having baseline DEXA BMD within normal range at both spine and left hip.|||percent of participants|||Number
1283594|NCT00223665|Secondary|Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS|Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm^2 as a indicator of bone health. Percent change was assess for each patient at each time point.|From screening prior to first dose of ADT through the start of the second cycle of ADT.|Out of 102 enrolled subjects, 56 were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), no prior or concurrent use of bisphosphonates, and a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2.|||Percent change of BMD|||Number
1283595|NCT00223665|Secondary|Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS|Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm^2 as a indicator of bone health for each patient at each time point.|From screening prior to first dose of ADT through the start of the second cycle of ADT.|56 subjects were evaluable for this outcome measure, defined as meeting all of the following: having completed first cycle of ADT (9 months); no prior or concurrent use of bisphosphonates; a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2.|||Percent change in BMD|||Number
1283596|NCT00223665|Primary|Effect of IAS on Overall Survival.|Assessment of overall survival measured as median time from completion of first full cycle of IAS until date of death from any cause.|From date of first treatment until the date of death or study withdrawal, whichever came first, assessed up to 16 years.|62 subjects were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), having a measurable treatment break afterwards, and having sufficient data to assess survival status.|||years||Full Range|Median
1283621|NCT00222105|Primary|Overall Response Rate|Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.|At End of Cycle 1, 28 Days|Five subjects did not complete first cycle.|||percentage of participants|||Number
1288794|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg|24-hour fed Leptin dose 0.3 mg/kg|1 DAY||||NG*H/ML||Standard Deviation|Mean
1283597|NCT00223665|Primary|Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA)|Monthly Prostate-Specific Antigen (PSA) testing to assess the point at which each patient's disease stops responding to Androgen Deprivation Therapy (ADT). Androgen Independence (AI), also know as Castrate Resistance (CR), was defined as 2 serial rises in PSA while on ADT with Testosterone levels <50 ng/dL.|From date of first treatment until the date of development of CR, metastatic progression, or study withdrawal, whichever came first, assessed up to 16 years.|62 subjects were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), having a measurable treatment break afterwards, and having sufficient PSA measurements to assess androgen independence.|||years||Full Range|Median
1283598|NCT00223652|Secondary|Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up|"Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE).~A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up."|6-month follow up at week 44 post treatment||||participants|||Number
1283599|NCT00223652|Secondary|Maintenance of Treatment Effect|"6-month post treatment follow-up on outcome measure of the Patient Health Questionnaire-9 (PHQ-9).~Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9.~PHQ-9 score ranges from 0-27, higher values indicate more severe depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively."|6-month post treatment follow-up||||units on a scale||Standard Deviation|Mean
1283600|NCT00223652|Primary|Number of Participants Meeting Criteria for Major Depressive Disorder|Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.|Baseline to week 12, and week 20||||participants|||Number
1283601|NCT00223652|Primary|Change in Severity of Depression Using the Patient Health Questionnaire-9|"Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9).~Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.~PHQ-9 score ranges from 0-27, higher values indicate more severe depression."|Baseline, Week 12, Week 20||||units on a scale||Standard Deviation|Mean
1283602|NCT00223652|Secondary|Maintenance of Treatment Effect|"Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.~Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression."|6 month follow-up (week 44)||||units on a scale||Standard Deviation|Mean
1283603|NCT00223652|Primary|Change in Severity of Depression Using Hamilton Depression Rating Scale|"Evaluators administered the Hamilton Depression Rating Scale(Ham-D).~Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D).~Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.~Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression."|Baseline, 12 weeks, 20 weeks||||units on a scale||Standard Deviation|Mean
1283604|NCT00223496|Primary|Primary Measure:Reduction in Depression Symptoms|Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).|up to 12 weeks||||participants|||Number
1283605|NCT00223236|Secondary|Rey Auditory Verbal Learning Test(RAVLT)|The RAVLT consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. The total score is the total number of words recalled through the five trials. Normative RAVLT T-scores was used. the higher T score, the better memory. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in RAVLT T scores between baseline and exit (exit - baseline).|Change in T scores between baseline and exit (exitT score - baseline T score).|number of participants are calculated based on those who completed baseline and at least one treatment visit.|||T score||Standard Deviation|Mean
1283606|NCT00223236|Secondary|Young Mania Rating Scale(YMRS).|The YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal and and 4 or 8 =most abnormal. The total possible score is 0 to 60, 0 being no symptom and 60 the worst symptom. The higher the score, the worse the mania symptoms are. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).|Baseline to exit (exit score - baseline score)|Numbers of participants are those who completed baseline assessment and at least one treatment visit.|||units on a scale||Standard Deviation|Mean
1283607|NCT00223236|Secondary|Inventory of Depressive Symptomatology Self Report (IDS-SR).|The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. The each item has a 4-likert scale, 0 to 3, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the tudy period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).|Change in scores between baseline and exit (exit - baseline).|Number of participants reported are those who completed baseline assessment and at least one treatment visit.|||units on scale||Standard Deviation|Mean
1283608|NCT00223236|Primary|Cocaine Use Determined by Urine Analysis|Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks.|Biweekly (visit) urine drug screens|Number of participants are those who completed baseline assessment and at least one treatment visit followed by baseline.|||percentage of participants no cocaine|||Number
1283609|NCT00223080|Secondary|Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)|Self Report of Risk Behavior Status by Treatment and Time. Specifically, this is the responses to the question “Do you think that your everyday behavior puts you at risk for HIV infection?” Modified intent to treat population (MITT)|Week 182|Prior to the analysis, the SAP identified the MITT as those participants who were infection free at entry into the study. Although individuals were screened for HIV antibody prior to entry, individuals identified by laboratory examination of PCR assessments of blinded pre-randomization specimens that were performed subsequent to entry were excluded|||participants|||Number
1283610|NCT00223080|Secondary|Safety Assessment (SAE's and AEs)|The intent-to-treat population is used for analysis of AEs and treatment emergent events are reported. Participant AE rates for all AEs, SAEs and treatment-related AEs are summarized|Dose Interval 1: week 0, Dose Interval 2: Week 4, Dose Interval 3: Week 12, and Dose Interval 4: Week 24; every 6 months during 3 year f/u period|intent-to-treat population|||adverse events|||Number
1283611|NCT00223080|Primary|Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population|Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.|42 months|Per-protocol population: The per-protocol analysis is restricted to the individuals who were infection-free at the completion of vaccination and who received a timely set of 4 vaccinations.|||log [HIV-1 viral load (unitless)]||Standard Error|Mean
1283612|NCT00223080|Primary|Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population|Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.|42 months|Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study|||log [HIV-1 viral load (unitless)]||Standard Error|Mean
1283613|NCT00223080|Secondary|Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population|Two CD4 cell counts were obtained (at the verification blood draw and the notification blood draw) and through the remainder of the follow-up period. Results were compared in vaccine and placebo recipients who became HIV-infected during the trial.|42 weeks|Prior to the analysis, the SAP identified the MITT as those participants who were infection free at entry into the study. Although individuals were screened for HIV antibody prior to entry, individuals identified by laboratory examination of PCR assessments of blinded pre-randomization specimens that were performed subsequent to entry were excluded|||cells / µL||Standard Error|Mean
1283614|NCT00223080|Primary|Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population|Cumulative Number of HIV Infections. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.|42 Months|Per-protocol population: The per-protocol analysis is restricted to the individuals who were infection-free at the completion of vaccination and who received a timely set of 4 vaccinations.|||Percentage of subjects||95% Confidence Interval|Number
1283615|NCT00223080|Primary|Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population|HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.|42 Months|Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study|||Percetage of subjects||95% Confidence Interval|Number
1283616|NCT00222729|Secondary|Overall Survival (OS)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg|||months||90% Confidence Interval|Median
1283617|NCT00222729|Secondary|Disease Control Rate (DCR)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg|||percentage||90% Confidence Interval|Median
1283618|NCT00222729|Secondary|Objective Response Rate (ORR)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2|||percentage||90% Confidence Interval|Median
1283619|NCT00222729|Primary|Time-to-progression (TTP)|TTP was calculated from treatment initiation to disease progression or last follow-up.|Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2|||months||90% Confidence Interval|Median
1283622|NCT00221299|Primary|Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.|In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.|BMD changes from year 1 to year 2|Per protocol|||percent change||Standard Deviation|Mean
1283623|NCT00221195|Primary|Reduction in the Number of Bleeds||6 months||||bleeds||Standard Deviation|Mean
1283624|NCT00221117|Secondary|Spinal Cord Independence Measure (SCIM).|Score range from 0-100. Higher score represent a better outcome.|30 min||||units on a scale||Standard Deviation|Mean
1283625|NCT00221117|Secondary|Rehabilitation Engineering Laboratory Hand Function Test(REL Test)|The Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) evaluates gross motor function of unilateral grasp (also referred to as the Rehabilitation Engineering Laboratory Hand Function Test). Hand functions that are assessed with TRI-HFT include the following: lateral or pulp pinch and palmar grasp.Score range from 0-70. Higher values represent a better outcome.|45 min|The subject’s impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data.|||units on a scale||Standard Deviation|Mean
1283626|NCT00221117|Primary|Functional Independence Measure (FIM)|Functional Independent Measure was employed to measure the degree of disability for daily self care. It capture data on self-care, sphincter management, transfers,locomotion,communication,and social cognition.The scale is divided according to no helper category (level 6 and 7) where no other person is required to help with the activity and a hel;per category(level 1 through 5)where the patient needs minimal to total assistance from another person to accomplish the activity Score range from 18-126. Higher values represent a better outcome.|35 min||||units on a scale||Standard Deviation|Mean
1283627|NCT00221104|Secondary|Incidence Rate of Intracranial Hemorrhage|Incidence rate of patients with intracranial hemorrhage|up to 5 years|intention to treat|||events /100 person-years||95% Confidence Interval|Number
1283628|NCT00221104|Secondary|Incidence Rate of Cardioembolic Infarction|Incidence rate of patients with cardioembolic infarction|up to 5 years|intention to treat|||events /100 person-years||95% Confidence Interval|Number
1283629|NCT00221104|Secondary|Incidence Rate of Lacunar Infarction|Incidence rate of patients with lacunar infarction|up to 5 years|intention to treat|||events /100 person years||95% Confidence Interval|Number
1283630|NCT00221104|Secondary|Incidence Rate of Atherothrombotic Infarction|Incidence rate of patients with atherothrombotic infarction|up to 5 years|intention to treat|||events /100 person-years||95% Confidence Interval|Number
1283631|NCT00221104|Primary|Incidence Rate of Stroke and TIA|Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)|up to 5 years|intention to treat|||events /100 person-years||95% Confidence Interval|Number
1283632|NCT00220961|Secondary|Change in Atherosclerosis|carotid intima thickness|Baseline versus 2.4 years||||percentage of intima||Standard Deviation|Mean
1283633|NCT00220961|Secondary|Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values)|Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity.|Baseline versus 2.4 years||||matsuda index||Standard Deviation|Mean
1283634|NCT00220961|Secondary|Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test|Insulin secretion|Baseline versus 2.4 years||||nmol||Standard Deviation|Mean
1283635|NCT00220961|Secondary|Change From Baseline in Fasting Plasma Glucose of 2.4 Years|Fasting Plasma Glucose|Baseline versus 2.4 years||||mg/dl||Standard Deviation|Mean
1283636|NCT00220961|Primary|Prevention of Type 2 Diabetes|Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization|2.4 years||||percentage of participants|||Number
1283637|NCT00220805|Secondary|Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center||At end of treatment (12 weeks)|Intent to Treat|||Disk Diameter||Standard Deviation|Mean
1283638|NCT00220805|Secondary|Presence of Fibrosis and Location Assessed by Slit-lamp||Last measurement at or later than Week 8|Intent to Treat|||participants|||Number
1283639|NCT00220805|Secondary|Proportion of Subjects With an Increase ≥ 2 or More Points in Lens Opacity Classification System (LOCS III) for Nuclear Opalescence, Nuclear Color, Cortical Cataract or Posterior Subcapsular Cataract Categories|The LOCS III scale for cortical cataract and posterior subcapsular cataract opacity ranged from 1.0 to 5.0. The LOCS III scale for nuclear opalescence and for nuclear color was 1.0 to 6.0. For all scales, higher values indicate higher opacity, opalescence, or color.|Last measurement at or later than Week 8|Intent to Treat subjects with cataract|||participants|||Number
1283640|NCT00220805|Secondary|Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)|The RADNER test gives not only information about the subject's reading performance, but also about the reading speed (life quality) and the faults while reading. The RADNER reading charts (1, 2, and 3) contain sentences in paragraphs having a range of print sizes starting with the largest print at the top.The subject was randomly assigned one of the RADNER charts, and the charts were different between consecutive visits. The reading distance was 25 cm. The subject's score was corrected for reading speed and errors. The range of possible logRAD scores was from 2.0 (could not read the first paragraph) to -0.2, with higher scores indicating lower reading acuity and lower scores indicating higher reading acuity.|Last measurement at or later than Week 8|Intent to Treat|||LogRAD||Standard Deviation|Mean
1283641|NCT00220805|Secondary|Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR||Last measurement at or later than Week 8|Intent to Treat|||percentage of participants|||Number
1283642|NCT00220805|Secondary|Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR||Last measurement at or later than Week 8|Intent to Treat|||percentage of participants|||Number
1283663|NCT00220636|Secondary|Clinical Global Impressions Improvement Scale (CGI)|clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)|12 weeks|all subjects for whom data was available after beginning aripiprazole augmentation (14 of 15 subjects)|||units on CGI scale||Standard Deviation|Mean
1283643|NCT00220805|Primary|Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period)|Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.|At Week 12 or, if the Week 12 assessment is not available, at the last LogMAR assessment conducted at or after Week 8 of the Treatment Period|The Intent-to-Treat (ITT) Population consisted of all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (LogMAR score) at Week 8 or later and at Baseline.|||LogMAR||Standard Deviation|Mean
1283644|NCT00220779|Primary|Percentage of Relapse Free Subjects (no Relapse)|A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.|12 months|Intent-to-Treat (ITT) Population was all randomized subjects. This was the primary analysis population.|||percentage of participants|||Number
1283645|NCT00220779|Secondary|Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)||1 year|||||||
1283646|NCT00220740|Secondary|Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period||6 months|In the Randomized Withdrawal Period, 43 subjects were randomized to IGIV-C, but only 31 out of the 41 subjects were prior IGIV-C responders or rescue successes. Similarly, 31 subjects were randomized to Placebo, but only 26 out of the 31 subjects were prior IGIV-C responders or rescue successes.|||weeks||Standard Deviation|Mean
1283647|NCT00220740|Secondary|Mean Change in Grip Strength During the Efficacy Period||6 months|Intent-to-treat|||kilopascal||Standard Deviation|Mean
1283648|NCT00220740|Secondary|Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period|Mean changes in amplitude [mV] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent to treat population)|6 months|Intent-to-treat|||Millivolts||Standard Deviation|Mean
1283649|NCT00220740|Primary|Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period|"The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period.~Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10.~INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement.~INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help"|6 months|The Intent-to-Treat Population was defined as all randomized subjects. This population was the primary efficacy population to be analyzed.|||percentage of responders|||Number
1283650|NCT00220727|Primary|Change From Baseline in Platelet Levels||24 hours Post infusion and Day 7||||Giga/L||Standard Deviation|Mean
1283651|NCT00220727|Primary|Red Blood Cells|Red blood cells as a measure to assess hemolysis|24 hrs after treatment||||10^12 cells/L||Standard Deviation|Mean
1283652|NCT00220727|Primary|Hematocrit|Hematocrit as a measure to assess hemolysis|24 hrs after treatment||||percentage of blood||Standard Deviation|Mean
1283653|NCT00220727|Secondary|Number of Subjects With Infusion Related Adverse Events||48 hours after treatment||||participants|||Number
1283654|NCT00220727|Primary|Free Hemoglobin|Free hemoglobin as a measure to assess hemolysis.|24 hours after treatment||||g/dL||Standard Deviation|Mean
1283655|NCT00220701|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|Week 12||||units on a scale||Standard Deviation|Mean
1283656|NCT00220701|Secondary|Clinical Global Impressions - Severity (CGI-S)|Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)|Baseline||||units on a scale||Standard Deviation|Mean
1283657|NCT00220701|Primary|Hamilton-Depression Rating Scale (HDRS-24 Items)|Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)|Baseline||||units on a scale||Standard Deviation|Mean
1283658|NCT00220701|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|Baseline||||units on a scale||Standard Deviation|Mean
1283659|NCT00220701|Secondary|Clinical Global Impressions - Severity (CGI-S)|Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)|Week 12||||units on a scale||Standard Deviation|Mean
1283660|NCT00220701|Primary|Hamilton-Depression Rating Scale (HDRS-24 Items)|Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)|Week 12||||units on a scale||Standard Deviation|Mean
1283661|NCT00220636|Secondary|Change in Beck Depression Inventory (BDI) Score|"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.~Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment."|baseline and 12 weeks|Number of participants for whom data was available after starting aripiprazole augmentation|||points on BDI scale||Standard Deviation|Mean
1283662|NCT00220636|Secondary|Change in Global Assessment of Functioning Scale (GAFS)|Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.|baseline and 12 weeks|All subjects (14/15) for whom data was available after starting aripiprazole augmentation|||points on GAFS scale||Standard Deviation|Mean
1283664|NCT00220636|Primary|Hamilton Depression Rating Scale (HDRS)|"Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression responded after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12."|12 weeks|Adults with treatment resistant depression, all subjects with data after baseline (14 of 15 subjects).|||participants|||Number
1283665|NCT00219557|Secondary|Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study|QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from ‘1=not at all’ to 4=’very much’ and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms.|Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).|Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point.|||units on a scale||Standard Deviation|Mean
1283666|NCT00219557|Secondary|Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).|Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point.|||units on a scale||Standard Deviation|Mean
1283667|NCT00219557|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate.|Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.|||Percent chance of survival||95% Confidence Interval|Number
1283668|NCT00219557|Secondary|Progression-free Survival (PFS)|"Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.|||Days||95% Confidence Interval|Number
1283669|NCT00219557|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks|Subgroup of participants from Phase 2 ITT population, with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
1283670|NCT00219557|Secondary|Percentage of Participants With Overall Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.|Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
1283671|NCT00219557|Secondary|Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks|||||||
1283672|NCT00219557|Secondary|Plasma Decay Half-life (t1/2) of Gemcitabine|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
1283673|NCT00219557|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1283674|NCT00219557|Secondary|Maximum Observed Plasma Concentration (Cmax) of Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1283675|NCT00219557|Secondary|Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.|||hr||Standard Deviation|Mean
1283676|NCT00219557|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)|Tmax was based on the actual time points when the samples were collected.|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.|||hr||Full Range|Median
1283677|NCT00219557|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)|AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Pase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.|||ng*hr/mL||Standard Deviation|Mean
1283678|NCT00219557|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)||0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 Pharmacokinetic (PK) evaluable population included all ITT participants who completed PK blood sampling on at least 1 day.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1283679|NCT00219557|Secondary|Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)|Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or nonhematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Phase 1 Baseline up to Week 4|Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1283680|NCT00219557|Secondary|Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)|Dose of axitinib (AG-013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or nonhematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Phase 1 baseline up to Week 4|Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1283681|NCT00219557|Primary|Overall Survival (OS)|Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant|Phase 2 intent to treat (ITT) population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.|||Days||95% Confidence Interval|Median
1283682|NCT00219544|Secondary|Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components|two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)|Week 9||||score on scale||Standard Error|Least Squares Mean
1283683|NCT00219544|Secondary|Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.|Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.|Week 9|FAS population|||score on scale||Standard Error|Least Squares Mean
1283684|NCT00219544|Secondary|Patient Global Impression of Change (PGIC) Categories by Number of Subjects|"Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject’s overall status on a 7-point scale. Scores range from~1 (very much improved) to 7 (very much worse)."|Week 9|FAS Population|||participants|||Number
1283685|NCT00219544|Secondary|Change in Pain Treatment Satisfaction Scale (PTSS)|"Mean Change: score from observation minus score from randomization: PTSS “Impact” module of 8-items & “Satisfaction” module of 6-items; item scores 1-5.~Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100~=best possible response: Score =[(5 – mean non-missing items)*100]/4."|Week 9||||score on scale||Standard Error|Least Squares Mean
1283761|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283686|NCT00219544|Secondary|Change in Hospital Anxiety and Depression Scale Responses|Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.|Week 9|FAS population|||score on scale||Standard Error|Least Squares Mean
1283687|NCT00219544|Secondary|Intensity of Neuropathic Pain –Visual Analog Scale (NeP – VAS)|Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain –Visual Analog Scale (NeP – VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 4, Week 9||||scores on a scale||Standard Error|Least Squares Mean
1283688|NCT00219544|Secondary|Change in Sleep Interference Scores During Double Blind Treatment Phase|"Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep."|9 weeks|Full Analysis Set (FAS)|||score on scale||Standard Error|Least Squares Mean
1283689|NCT00219544|Secondary|Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase|Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|Week 9||||score on scale||Standard Deviation|Mean
1283690|NCT00219544|Secondary|Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase|Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|0 and 4 weeks|Last observation carried forward (LOCF) approach for patients who do not complete the study will be adopted. This is defined as the mean of the last 7 diary scores while on Double-Blind study drug, up to and including the day after the last day on drug (excluding the taper phase).|||score on scale||Standard Deviation|Mean
1283691|NCT00219544|Secondary|Mean Sleep Interference Score|Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|Week 9|FAS population.|||score on scale||Standard Error|Least Squares Mean
1283692|NCT00219544|Secondary|Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)|Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .|Week 9||||participants|||Number
1283693|NCT00219544|Secondary|Categorized Daily Pain Score|Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)|Week 9|Number of subjects analyzed for each pain category.|||days||Standard Deviation|Mean
1283694|NCT00219544|Secondary|Mean Pain Score for Non-responders at End of Single-blind Treatment Phase|Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 (“no pain”) to 10 (“worst possible pain”). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.|Week 4|number of subjects that can be analyzed for Change from Baseline at End of Single Blind.|||score on scale||Standard Deviation|Mean
1283695|NCT00219544|Secondary|Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.|Daily Pain Rating Score:11-point numerical scale 0 (“no pain”) to 10 (“worst possible pain”). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.|Week 4|number of subjects that can be analyzed for Change from Baseline at End of Single Blind.|||score on scale||Standard Deviation|Mean
1283696|NCT00219544|Secondary|Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment|Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|Week 4 (end of single-blind treatment phase)|256 subjects entered the single-blind treatment phase, one subject did not have enough DPRS assessments for calculation.|||participants|||Number
1283697|NCT00219544|Secondary|Change in Pain Scores During Double Blind Treatment Phase|Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|9 weeks|Full Analysis Set (FAS)|||score on scale||Standard Error|Least Squares Mean
1283698|NCT00219544|Secondary|Weekly Mean Pain Scores During the Double Blind Treatment Phase|Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|Week 4 - 9|FAS population.|||score on scale||Standard Deviation|Mean
1283699|NCT00219544|Secondary|Weekly Mean Pain Scores During the Single-blind Treatment Phase|Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|0 and 4 weeks|Full Analysis Set (FAS)|||score on scale||Standard Deviation|Mean
1283762|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in the Past Month)||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283700|NCT00219544|Primary|Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase|Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|9 weeks|Full Analysis Set (FAS) = Intent-to-Treat (ITT) population, defined as all subjects who are randomized into the Double-Blind treatment phase, who receive at least one dose of Double-Blind study medication and complete at least one postrandomization efficacy assessment.|||score on scale||Standard Error|Least Squares Mean
1283701|NCT00219349|Secondary|Change in Beck Depression Inventory-II|total score ranges from 0 (not depressed) to 63 (most severe)|week 14 to week 26||||units on a scale||Standard Deviation|Mean
1283702|NCT00219349|Secondary|Change in Hamilton Rating Scale for Depression|24 item version of this standard depression scale, total score ranges from 0 (not depressed) to 58 (most severe)|week 14 to week 26||||units on a scale||Standard Deviation|Mean
1283703|NCT00219349|Secondary|Clinical Global Impressions-Improvement Index|This is a single item rating overall symptomatic improvement. Range is 0 (very much worse) to 7 (very much improved)|week 26||||units on a scale||Standard Deviation|Mean
1283704|NCT00219349|Primary|Change in State-Trait Anxiety Inventory, State Subscale|only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)|week 14 to week 26||||units on a scale||Standard Deviation|Mean
1283705|NCT00219349|Primary|Change in Penn State Worry Questionnaire|total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)|week 14 to week 26||||units on a scale||Standard Deviation|Mean
1283706|NCT00219349|Primary|Change in Generalized Anxiety Disorder Severity Scale|measures severity of symptoms of generalized anxiety disorder, reported as a total score summing 10 items that are each rated from 0, never to 4, all of the time. Range is 0 to 40, with 40 most severe.|week 14 to week 26||||units on a scale||Standard Deviation|Mean
1283707|NCT00219349|Primary|Change in Clinical Global Impressions-Severity Index|7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.|week 14 to week 26||||units on a scale||Standard Deviation|Mean
1283708|NCT00219349|Primary|Change in Hamilton Anxiety Rating Scale Score|The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.|week 14 to week 26|see above: Patients who completed the CBT phase and started escitalopram treatment|||units on a scale||Standard Deviation|Mean
1283709|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQ-39 scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283710|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQUALIF scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283711|NCT00219284|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment UPDRS part III scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283712|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQ-39 scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283763|NCT00218335|Primary|Any Sex Risk||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283713|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQ-39 scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283714|NCT00219284|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5-point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 UPDRS part III scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283715|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQUALIF scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283716|NCT00219284|Secondary|Change in Parkinson’s Disease Quality of Life Score From Baseline to Week 4|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQUALIF scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283717|NCT00219284|Primary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 UPDRS part III scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1283718|NCT00219141|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, blood pressure was measured at study specified intervals.|Baseline the end of study (Week 36)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||mm Hg||Standard Error|Least Squares Mean
1283719|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.|||mm * ms||Standard Deviation|Mean
1283720|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.|||mm||Standard Deviation|Mean
1283721|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mL||Standard Deviation|Mean
1283722|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||percent||Standard Deviation|Mean
1283723|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||g||Standard Deviation|Mean
1283724|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mm||Standard Deviation|Mean
1283725|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mm||Standard Deviation|Mean
1283726|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mm||Standard Deviation|Mean
1283727|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mL||Standard Deviation|Mean
1283728|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mL||Standard Deviation|Mean
1283729|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||g/m^2||Standard Deviation|Mean
1283730|NCT00219141|Primary|Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)|Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.|Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||g/m^2||Standard Error|Least Squares Mean
1283731|NCT00218634|Secondary|CD4+ Lymphocyte Count at 3-month Follow-up Assessment.|CD4+ lymphocyte cell count at 3-month follow-up assessment.|3-month assessment|We used intent to treat for all analysis.|||cells/mm3||Standard Deviation|Mean
1283732|NCT00218634|Secondary|HIV Viral Load at 3-month Follow-up Assessment|HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.|3-month assessment|We used intent to treat for all data analysis.|||"log10 copies/mL"||Standard Deviation|Mean
1283733|NCT00218634|Secondary|Clinician-assessed Depression at 12-month Follow-up Assessment|Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.|12-month follow-up assessment|We used intent to treat for all data analysis.|||Units on scale||Standard Deviation|Mean
1283734|NCT00218634|Primary|Percent Medication Adherence at 12-month Follow-up Assessment|Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.|12-month follow-up assessment|We used intent to treat for all data analysis.|||percent (doses taken/doses prescribed)||Standard Deviation|Mean
1283735|NCT00218634|Secondary|CD4+ Lymphocyte Count at 12-month Follow-up Assessment.|CD4+ lymphocyte cell count at 12-month follow-up assessment.|12-month follow-up assessment|We used intent to treat for all data analysis.|||cells/mm^3||Standard Deviation|Mean
1283736|NCT00218634|Secondary|HIV Viral Load at 12-month Follow-up Assessment|HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.|12-month follow-up assessment|We used intent to treat for all data analysis.|||log10 copies/mL||Standard Deviation|Log Mean
1283737|NCT00218634|Secondary|Clinician-assessed Depression Rating at 3 Month Follow-up Assessment|Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.|3 month follow-up|We used intent to treat for all data analysis.|||Units on scale||Standard Deviation|Mean
1283764|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 32|Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).|32 Weeks||||percentage of randomized|||Number
1283738|NCT00218634|Primary|Percent Medication Adherence at 3-month Follow-up Assessment|Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.|3-month assessment|We used hierarchical linear modeling (HLM) methods and intent to treat for all randomized participants.|||percent (doses taken/doses prescribed)||Standard Deviation|Mean
1283739|NCT00218543|Primary|ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)|Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.|measured during 12 weeks or length of study participation|Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed|||scores on a scale||Standard Deviation|Mean
1283740|NCT00218543|Primary|the Adult ADHD Rating Scale (AARS) (30% Reduction)|AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.|baseline compared to rating at week 12 or last rating during study participation|All participants|||percent of participants|||Number
1283741|NCT00218465|Primary|Days to Relapse Within the 60 Days Following Randomization||60 days||||days||Standard Deviation|Mean
1283742|NCT00218465|Primary|Number of Abstinent and Nonabstinent Participants at End of 5 Week Placebo-controlled Relapse Prevention Trial||5 weeks||||participants|||Number
1283743|NCT00218465|Primary|Time to Relapse to Smoking in the 5-week Relapse Prevention Phase.||5 weeks||||days||Standard Deviation|Mean
1283744|NCT00218439|Other Pre-specified|Plasma Norepinephrine Concentration Response to Stress|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||pg / ml||Standard Error|Mean
1283745|NCT00218439|Other Pre-specified|Plasma Epinephrine Concentration Response to Stress|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||pg / ml||Standard Error|Mean
1283746|NCT00218439|Other Pre-specified|Heart Rate Response to Stress|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||beats/minute||Standard Error|Mean
1283747|NCT00218439|Other Pre-specified|Diastolic Blood Pressure Response to Stress|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||mm Hg||Standard Error|Mean
1283748|NCT00218439|Primary|Systolic Blood Pressure Response to Stress|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||mmHg||Standard Error|Mean
1283749|NCT00218335|Primary|Talked About Hepatitis to Drug Buddies||18 months|Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283750|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283751|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in Past Month)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283752|NCT00218335|Primary|Injecting Drugs||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283753|NCT00218335|Primary|Number of Needle or Cooker Sharers (2 or More Versus None)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283754|NCT00218335|Primary|Shared Cooker When Preparing Drugs||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283755|NCT00218335|Primary|Any Injection Risk (Monthly Versus Never)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283756|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283757|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in the Past Month)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283758|NCT00218335|Primary|Number of Needle or Cooker Sharers (2 or More Versus None)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283759|NCT00218335|Primary|Any Injection Risk (Monthly Versus Never)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283760|NCT00218335|Primary|Talked About Responding to Overdose to Drug Buddies||6 months|Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
1283774|NCT00218062|Primary|Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment||16 weeks|All participants who received the first dose of study medication were included in this analysis.|||number of cocaine negative urines||Standard Deviation|Mean
1283775|NCT00218036|Secondary|Medication Compliance||12 weeks of treatment|The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.||||||
1283776|NCT00218036|Secondary|Retention||12 weeks of treatment|The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.||||||
1283777|NCT00218036|Primary|Confirmed Abstinence From Cocaine||12 weeks of treatment|The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.||||||
1283778|NCT00218023|Primary|Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline|Cocaine use was determined by assessing for the presence of benzoylecgonine in urine.|3 times per week (Monday, Wednesday, and Friday) for 12 weeks||||Mean % of cocaine-positive urines||Standard Error|Mean
1283779|NCT00218023|Primary|Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline|Cocaine use was determined by assessing for the presence of benzoylecgonine in urine.|3 times per week (Monday, Wednesday, and Friday) for 12 weeks||||Mean % of cocaine-positive urines||Standard Error|Mean
1283780|NCT00217971|Primary|Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial|Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.|weeks 7 and 8||||participants|||Number
1283781|NCT00217724|Secondary|Number of Participants With Attenuation of Myalgias or Arthralgias Not Receiving Glutamine as Measured by Pain Scale Diaries on Days 1 and 3 of Courses 1 and 2||Duration of participation on study (up to one year)|||||||
1283782|NCT00217724|Primary|Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy|Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by > 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by >25% from baseline scores|2 courses of chemotherapy (6 weeks)|Fourteen of the 18 patients enrolled received both cycles of therapy and were thus evaluable for the primary endpoint|||participants|||Number
1283783|NCT00217672|Secondary|Comparison of Safety and Toxicity|Evaluated using adverse event (AE) information. Detailed AE information is provided in the AE section.|When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of study||||subjects|||Number
1283784|NCT00217672|Secondary|Comparison of Response Rates, Duration of Response, and Overall Survival||Time of death, up to 3 years|Response rate – the percentage of patients assigned to a treatment arm who experience a CR or PR. Duration of response – the interval from date of initial documented response (CR or PR) to the first documented date of disease progression. Overall survival – the interval from the date of registration and the date of death.|||months||95% Confidence Interval|Median
1283785|NCT00217672|Primary|Antitumor Activity Based on Time to Tumor Progression (TTP).||From randomization until tumor progression|76 participants were registered to the Treatment, 7 to arm A and 69 to arm B. 6 participants randomized to arm A elected to cross over to arm B once Avastin became available. 2 out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. Thus, the efficacy analysis performed on 67 patients.|||months||95% Confidence Interval|Median
1283786|NCT00217620|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 – Severe, Grade 4 – Life-threatening, Grade 5 – Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1283787|NCT00217620|Primary|Objective Response (Confirmed, Complete and Partial)|Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.|Assessment performed every eight weeks until progression.|Eligible patients who had received any treatment were included in this analysis.|||participants|||Number
1283788|NCT00217620|Secondary|Four-month Progression-free Survival Rate||0 - 4 months|Eligible patients who had received any treatment were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
1283805|NCT00217399|Secondary|Number of Participants With Adverse Events|Number of patients treated with the sorafenib / anastrozole combination who experienced Grade 1-4 adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0|1 year|All 35 patients enrolled in the study were assessed for adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0.|||participants|||Number
1283789|NCT00217594|Primary|Response to Treatment - Hematologic Improvement or Complete Response|"Response to treatment at 3 months after the first dose of alemtuzumab. The parameters for hematologic improvement (HI) and complete response (CR) were defined according to the International Working Group (IWG) criteria. The IWG criteria for HI define specific responses of cytopenias in the 3 hematopoietic lineages: erythroid (HI-E), platelet (HI-P), and neutrophil (HI-N).7 The HIs are measured in patients with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or RBC-transfusion dependence, platelet count less than 100 × 109/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 × 109/L.~The parameters for CR include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L (11 g/dL) or more (in patients not receiving erythropoietin or transfusions), a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L."|3 months||||Participants|||Count of Participants
1283790|NCT00217581|Secondary|Overall Survival|Overall survival using the Kaplan-Meier method|Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years||||months||95% Confidence Interval|Median
1283791|NCT00217581|Secondary|Time to Treatment Failure|Time to treatment failure using the Kaplan-Meier method|Every 21 days||||months||95% Confidence Interval|Median
1283792|NCT00217581|Secondary|Toxicity Profile|Toxicity profile of grade 3 and grade 4 events|At 21 days following completion of study treatment||||Participants|||Count of Participants
1283793|NCT00217581|Secondary|Response Rate by RECIST Criteria|Response rate by RECIST criteria until progression|After every 2 cycles (1 cycle =21 days)||||percentage of responders||95% Confidence Interval|Number
1283794|NCT00217581|Primary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months||||months||95% Confidence Interval|Median
1283795|NCT00217490|Primary|Change in Percentage of Fat Consumed|Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.|Baseline and 3 months|Participants who returned for follow up visit|||Percentage of fat consumed||Standard Deviation|Mean
1283796|NCT00217490|Primary|Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months|Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.|Baseline and 3 months|Participant who returned for follow up visit|||number of servings per day||Standard Deviation|Mean
1283797|NCT00217464|Secondary|Number of Participants With Progressive Disease at Day +90|Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value|90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment|All treated and eligible patients|||participants|||Number
1283798|NCT00217464|Primary|Proportion of Patients Who Respond to Treatment.|Response is defined to be the clear slowing of the rate of increase of PSA levels with time|90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1283799|NCT00217438|Secondary|Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2|Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.|Up to day 56 after transplant|Patients who were treated per protocol.|||Grade 3-4 adverse events|||Number
1283800|NCT00217438|Primary|CR and Near CR Rates|"Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. Near Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey."|Up to 120 days after transplant|Per protocol, patients who completed the day 80-120 evaluation assessments.|||percentage of participants|||Number
1283801|NCT00217425|Secondary|3-Year Overall Survival|3-year overall survival is defined as the probability of patients surviving at 3 years from study entry.|Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.|Eligible and treated patients|||probability||95% Confidence Interval|Number
1283802|NCT00217425|Secondary|Overall Response Rate|Overall response rate is defined as proportion of patients who achieve complete remission [CR, unconfirmed CR (CRu) or Functional CR] or partial remission. Response is assessed using the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma (Chesen, 1999).|Assessed after cycle 3, cycle 6, and cycle 8 (if given).|Eligible and treated|||proportion||95% Confidence Interval|Number
1283803|NCT00217425|Primary|12-Month Progression-Free Survival (PFS)|12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry.|Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.|Eligible and treated patients|||probability||95% Confidence Interval|Number
1283804|NCT00217399|Secondary|Tumor Marker Analysis|Number of participants with significant change in the following circulating tumor biomarkers, measured by flow cytometry: cluster designation (CD)146, CD133. Values were normalized by CD45 values(ie CD146+/CD45- and CD133+/CD45-).|1 year|14 subjects had blood specimens available for analysis|||participants|||Number
1283806|NCT00217399|Primary|Complete Response + Partial Response + Stable Disease > 24 Weeks|"Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking.~A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks."|24 weeks|Female patients with advanced or metastatic breast cancer. The protocol was initiated with intention to treat every patient enrolled with a sorafenib and anastrozole combination.|||participants|||Number
1283807|NCT00217087|Primary|Change in Quality of Life|Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36|end of study|25 patients did not return completed SF36 at 12 month of follow up their results were not used in final analysis.|||participants|||Number
1283808|NCT00217087|Primary|Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.|"Whether or not positive fish markers measured by polysomy were associated with outcomes.~Markers in this study include: 9q21 /017q (her2) / 8q24/ 20q / CEP17 / 17p. Polysomy and Trisomy were documented."|12 months post therapy|4 participants in the PDT group completed at least 3 months of follow up but not 12 months|||participants|||Number
1283809|NCT00217087|Primary|Level of Dysplasia on Histology at 12 Months|All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus|12 months post therapy|4 participants in the photodynamic therapy group completed at least 3 but less than 12 months follow up post therapy, so they were not included in this analysis.|||paricipants|||Number
1283810|NCT00217022|Secondary|Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies|The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale (“normal” (0), “mildly increased” (1), “moderately increased” (2), “severely increased” (3)).|Baseline (day 1 of study) and at eight weeks (approximately)|Only 8 of the subjects on the budesonide arm returned for the biopsy, so only those subjects on that arm were analyzed for this outcome measure.|||participants|||Number
1283811|NCT00217022|Primary|Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks|"Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of satisfactory control of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks."|Three out of last four weeks that the subject was on the study||||participants|||Number
1283812|NCT00216736|Post-Hoc|Proportion of Patients With Recurrent Headache Within 48 Hours for Patient Subgroup With Duration of Migraine Less Than 24 Hours|Proportion of patients who report recurrent headache within 48 hours for the patient subgroup with duration of migraine less than 24 hours|48 hours||||Participants|||Number
1283813|NCT00216736|Secondary|Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.|Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.|48 hours||||Participants|||Number
1283814|NCT00216736|Primary|Proportion of Patients With Recurrent Headache Within 48 Hours.|Proportion of patients who report recurrent headache within 48 hours, on telephone followup.|48 hours||||Partcipants|||Number
1283815|NCT00216736|Primary|Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.|Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.|48 hours||||Participants|||Number
1283816|NCT00216671|Secondary|Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12|Short Form Health Survey: A generic dual–ie, mental and physical health–scale measure of quality of life. This is a 12-item subset of the SF-36 survey that measures the same 8 domains of health. As a brief, reliable measure of overall health status, the SF-12 is the instrument of choice in large population health surveys and has been used extensively as a screening tool. SF-12 will be filled in by the patient. The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.An additional 9 and 11 patients in the respective groups had missing SF-12 data.|||scores on a scale||Standard Deviation|Mean
1283817|NCT00216671|Secondary|Change From Baseline to Endpoint in Global Assessment of Functioning (GAF)|Overall psychological, social, and occupational functioning is rated on a scale of mental health-illness from 1 being the worst functioning to 100 being the best. Impairment in functioning due to physical (or environmental) limitations must not be included in the rating.|at baseline and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initation group has missing GAF data.|||scores on a scale||Standard Deviation|Mean
1283818|NCT00216671|Secondary|Change From Baseline to Endpoint in Clinical Global Impression – Severity (CGI-S)|The CGI-S rating scale is used to rate the severity of a subject’s psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the subject’s condition at a given time.|at baseline and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initiation group has missing CGI-S data.|||scores on a scale||Standard Deviation|Mean
1283819|NCT00216671|Secondary|Change From Baseline in PANSS Total Score at Week 12|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210.|at baseline and Week 12.|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 9 and 23 patients in the respective groups had missing PANSS data.|||scores on a scale||Standard Deviation|Mean
1283831|NCT00216203|Secondary|Clinical Benefit Rate|Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)|12 months|Data was not collected or analyzed for this secondary objective.||||||
1283832|NCT00216203|Secondary|Toxicity and Safety Profile||12 months||||percentage of particpants|||Number
1283820|NCT00216671|Secondary|Change From Baseline in PANSS Total Score at Week 6|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210.|at baseline and Week 6.|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 3 and 5 patients in the respective groups had missing PANSS data at week 6.|||scores on a scale||Standard Deviation|Mean
1283821|NCT00216671|Primary|Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).The total score can range from 30 to 210.|at baseline and Week 26 or at premature discontinuation|Per Protocol analysis: all randomized patients who had no violation on eligibility criteria or no major protocol violation. This excluded 42 patients in the early and 34 in the late initiation group. 1 patient in the early initiation group had no PANSS at endpoint. The endpoint is the last post-baseline value of the patient.|||scores on a scale||Standard Deviation|Mean
1283822|NCT00216476|Secondary|Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores|Quality of life was assessed by means of the 12-item SF-12® survey. Two parameters, i.e., PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better QOL.|Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. An additional 32, 32, and 2 subjects in the respective arms did not have SF-12 data.|||units on a scale||Standard Deviation|Mean
1283823|NCT00216476|Secondary|Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score|The 7-point CGI scale of Severity (CGI-S) was used to assess the severity of a subject’s psychotic condition (0= normal, not at all ill, 1= borderline, etc. and 6= among the most extremely ill subjects).|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm, 11 of the quetipaine arm, and 1 of the aripiprazole arm. One additional subject in the risperidone LAI arm did not have CGI data.|||units on a scale||Standard Deviation|Mean
1283824|NCT00216476|Secondary|Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score|"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item PANSS scale. The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, i.e., the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).~Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme)."|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. One additional subject in each the risperidone LAI and quetiapine arm did not have PANSS data.|||units on a scale||Standard Deviation|Mean
1283825|NCT00216476|Secondary|Mean Relapse Free Period (Exploratory/Aripiprazole)|As for risperidone and quetiapine, relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. Since aripiprazole was new on the market at the time the study was conducted, this aripiprazole analysis was exploratory.|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 1 subject of the aripiprazole arm.|||days||Standard Error|Mean
1283826|NCT00216476|Primary|Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)|Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm and 11 of the quetiapine arm.|||days||Standard Deviation|Mean
1283827|NCT00216320|Primary|10 Meter Walking Speed Before and After Intervention.|Subjects walked 10 meters at their fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks||||meters/second||Standard Deviation|Mean
1283828|NCT00216320|Primary|Physiological Cost Index Before and After Intervention.|PCI is the difference between resting heart rate and active heart rate during walking, divided by average walking speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks||||beats/minute||Standard Deviation|Mean
1283829|NCT00216320|Primary|Figure 8 Walking Speed Before and After Intervention.|Subjects walked a 10 meter Figure 8 pattern for four minutes at fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks||||meters/second||Standard Deviation|Mean
1283830|NCT00216320|Secondary|Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO|Subjects in Arm 1 or 2 (who used both devices) were given the option to continue using WalkAide or AFO for additional 12 weeks, their preference was recorded along with reasons for preference|12 weeks|per protocol (completers) analysis|||participants|||Number
1283834|NCT00216203|Primary|Time To Progression (TTP)|The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|24 Months|27 participants had enough data to complete TTP analysis|||Weeks||95% Confidence Interval|Median
1283835|NCT00216203|Primary|Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab|The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab|12 months|12 participants participated in the phase I portion of the trial.|||mg/m^2 every 21 days|||Number
1283836|NCT00216125|Secondary|Progression Free Survival|"A comparison of progression free survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median PFS time and a log rank test were used to analyze the hypothesized improvement in progression free survival.~Progression is defined by RECIST as a 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion."|Participants were monitored from treatment initiation until disease progression per RECIST or death||||months||95% Confidence Interval|Median
1283837|NCT00216125|Primary|Overall Survival|A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.|Participants were measured from treatment initiation to death|The analysis cohort for the results reported below are based on a planned interim DSMB evaluation conducted in 2006. This evaluation concluded that further accrual was futile and the study should be terminated. The 203 subjects included in this analysis had data sufficiently mature at the time of the DSMB analysis.|||Months||95% Confidence Interval|Median
1283838|NCT00216099|Secondary|Time to Prostate-Specific Antigen (PSA)/Serological Progression|Serological Progression (sPD) – increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline|From study enrollment to progression per PSA criteria (for life)||||months||95% Confidence Interval|Median
1283839|NCT00216099|Secondary|Time to Progression|Progression per Response Evaluation Criteria in Solid Tumors (RECIST) or Prostate-Specific Antigen (PSA) Progression RECIST PD=at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions PSA progression=increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline *Note, upper confidence interval was not reached*|Study enrollment until progression per RECIST or PSA (for life)||||months||95% Confidence Interval|Median
1283840|NCT00216099|Secondary|RFC1 G80A Genotype|Samples for RFC1 G80A pharmacogenetic analysis were collected at screening|Screening|Samples were available from 46 patients|||participants|||Number
1283841|NCT00216099|Secondary|Safety and Tolerability|Safety and Tolerability was evaluated by reporting the percentage of patient who experienced grade 3 or 4 toxicities using Common Terminology Criteria for Adverse Events CTCAE v3.0 criteria. CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.|18 months||||percentage of participants||95% Confidence Interval|Number
1283842|NCT00216099|Secondary|Rate of Clinical Benefit|"A clinical benefit is defined as an improvement for at least 3 consecutive weeks in at least one of the following parameters without any sustained worsening in any other:~> 50% reduction in analgesic consumption or > 50% reduction in pain intensity or > 20 point gain in performance status."|Any time among evaluable subjects (for life)||||percentage of participants||95% Confidence Interval|Number
1283843|NCT00216099|Secondary|OBJECTIVE Overall Response Rate|"Response Evaluation Criteria in Solid Tumors (RECIST). Objective overall response rate is defined as Complete Response (CR) + Partial Response (PR)~Per RECIST:~CR= Disappearance of all target and non-target lesions and normalization of tumor marker level PR= Disappearance of all target lesions and persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits OR at least a 30% decrease in the sum of the longest diameter, taking as reference the baseline sum longest diameter and disappearance of all non-target lesions or persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits"|Start of treatment until disease progression/recurrence (for life)|Patients who had measurable disease per RECIST 1.1 at baseline. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan.|||percentage of participants||95% Confidence Interval|Number
1283844|NCT00216099|Secondary|Overall Survival||From study enrollment until death (for life)||||months||95% Confidence Interval|Median
1283845|NCT00216099|Primary|Best Overall PSA Response|"Best overall Prostate-Specific Antigen (PSA) response~PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline"|Start of treatment until disease progression/recurrence (for life)||||percentage of participatns||95% Confidence Interval|Number
1283846|NCT00216086|Secondary|Disease-Free Survival|The three year rate of Disease-Free Survival|36 months||||percentage||95% Confidence Interval|Number
1283847|NCT00216086|Secondary|Rate of Clinical Response|To determine the rate of clinical response following induction chemotherapy with capecitabine and irinotecan, and also the overall clinical response after the completion of chemoradiation with capecitabine.|36 months|Data for this secondary objective was not captured or analyzed due to the withdrawal of funding and subsequent termination of the study.||||||
1283848|NCT00216086|Secondary|Local and Distant Disease Recurrence Rates|To determine the rates of local and distant disease recurrence after treatment.|36 months||||percentage of particpants|||Number
1283849|NCT00216086|Primary|Pathological Complete Response (pCR) Rate|"· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer.~Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients."|36 months||||percentage of patients||95% Confidence Interval|Number
1283850|NCT00216060|Secondary|Bone Turnover Marker Changes-- Serum Osteocalcin (OC)|Serum Osteocalcin (OC) medians between baseline and 24 weeks areperformed with the Elecsys 2010 automated analyzer, which uses an electrochemiluminescence immunoassay technique for the in vitro quantitative determination of serum total osteocalcin in humanserum. The assay uses a sandwich test principle in which afirst biotinylated monoclonal antibody recognizing N-MID osteocalcin and a second monoclonal antibody against N-MID osteocalcin labeled with ruthenium are incubated with 20mL of serum. After a first incubation, streptavidin-coated microparticles are added for a second incubation, and the complex becomes bound to the solid phase by interaction of biotin and streptavidin.These microparticles are then magnetically captured onto the surface of an electrode. Application of a voltage on this electrode induces chemiluminescent emission, which is measured by a photomultiplierand compared with a calibration curve that is generated in aninstrument-specific manner by 2-point calibration.|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.|||ug/L||Standard Deviation|Median
1283851|NCT00216060|Secondary|Bone Turnover Marker Changes-- Serum BAP|Serum BAP median changes between baseline and week 24. The Ostase assays are performed with an access immunoassay system, which is an assay of serum samples that provides a quantitative measurement of bone alkaline phosphatase (BAP). A mouse monoclonal antibody specific to BAP is added to a re-action vessel with paramagnetic particles coated with goat antimouse polyclonalantibody.Calibrators,controls,andsamplescontainingBAP are added to the coated particles and bind to the anti-BAP monoclonal antibody. After the formation of a solid phase/capture antibody/BAP complex, separation in a magnetic field and washing remove materials not bound to the solid phase. A chemiluminescent substrate, LumiPhos 530, is added to the reaction vessel, and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BAP in the sample. The amount of analyte in thesample is determined from a stored multipoint calibration curve|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.|||ng/mL||Standard Deviation|Median
1283852|NCT00216060|Secondary|Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median|"Urine N-telopeptide (NTX) median changes between baseline and week 24. The assays are performed with the NTx Reagent Pack kit from Ortho-Clinical Diagnostics (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK), which is a kit designed for the quantitative determination of N-terminal telopeptide (NTx) in human urine on the automated Vitros Immunodiagnostic System ECi (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK). A competitive immunoassay technique is used. This depends on competition between NTx present in the sample and a synthetic NTx peptide coated on the wells for binding by a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-NTx). The conjugate is captured by the peptide coated on the wells; unbound materials are removed by washing.~The bound HRP conjugate is measured by a luminescent reaction."|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.|||nmol BCE/mmol creatinine||Standard Deviation|Median
1283853|NCT00216060|Secondary|Three- Year Survival Rate||36 months||||percentage of participants||95% Confidence Interval|Number
1283854|NCT00216060|Secondary|Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)|"Urine total DPD median in response to treatment on both study arms at week 24. compare median from baseline and week 24.~Deoxypyridinoline (DPD) is measured in hydrolyzed urine samples using high-performance liquid chromatography technique. After extraction of the cross-links and elimination of the urine impurities by a Bio-Rad SPE cartridge (Bio-Rad Laboratories, Hercules, CA), total DPD is eluted from reverse-phase high-performance liquid chromatography by ion pair chromatography with isocratic elution.~The compounds are detected as a result of their natural fluorescence with a fluorescence detector"|24 weeks|Number of Participants Analyzed reflects participants who had data available prior to study termination.|||nmol/mmol creatinine||Standard Deviation|Median
1283855|NCT00216060|Secondary|Time to Development of Hormone Refractory Disease||36 months|No data were collected for this Outcome Measure due to low accrual and subsequent study termination.||||||
1283856|NCT00216060|Secondary|Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL||36 months||||percentage of participants|||Number
1283857|NCT00216060|Primary|Numbers of SRE or Death Occurred Cumulatively|Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)|36 months||||participants|||Number
1283858|NCT00215943|Secondary|Overall Survival (OS), by Treatment Arm|"Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive.~Investigators had planned to accrue 176 participants to calculate median overall survival."|Up to 10 Years|All participants with evaluable follow-up data.|||months||Full Range|Median
1283859|NCT00215943|Secondary|Number of Participants With Progression Free Survival (PFS), by Treatment Arm|"Number of participants with PFS for thalidomide/Dexamethasone vs. VAD with respect to progression free survival in newly diagnosed MM. Progressive Disease (PD): (for patients not in CR) Requires one or more of the following; > 25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.~> 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg and confirmed on a repeat investigation.~>25% increase in plasma cells in a bone marrow aspirate, which also must be an absolute increase of at least 10%. Definite increase in the size of existing lytic lesions or plasmacytomas. Development of new bone lesions or plasmacytomas (except compression fractures). Development of hypercalcemia (corrected calcium > 11.5 mg/dL not attributable to other causes)."|4 Months|All evaluable participants|||participants|||Number
1283860|NCT00215943|Secondary|Number of Participants With Adverse Events, by Group|Number of participants with toxicities of Thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed multiple myeloma (MM).|4 Years, 7 Months|All evaluable participants|||participants|||Number
1283861|NCT00215943|Primary|Response Rates of VAD vs. Thalidomide/Dexamethasone|Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of serum monoclonal protein for at least 2 determinations 2 weeks apart.|End of Cycle 4 - 4 Months per Participant|All evaluable participants|||participants|||Number
1283862|NCT00215930|Secondary|Progression Free Survival (PFS)|PFS was recorded as the time elapsed from the date of first treatment to the date of first evidence for disease progression or death. OS and PFS probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.|24 Months|Review of all participants for Number at risk, Number of events, Number censored.|||Months||Full Range|Median
1283863|NCT00215930|Secondary|Overall Survival (OS)|Median Overall Survival of Participants. OS and Progression Free Survival (PFS) probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.|24 Months|Review of all participants per protocol for Number at risk, Number of events, Number censored.|||Months||Full Range|Median
1283864|NCT00215930|Primary|Best Disease Response After a Maximum of Six Cycles.|Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy.|24 Months|All participants were analyzed according to Response Evaluation Criteria in Solid Tumors (RECIST).|||Participants|||Number
1283865|NCT00215787|Primary|Presence of Reflux in Patients With Polyposis|Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.|one year||||participants|||Number
1283866|NCT00215683|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|5 years|The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.|||participants|||Number
1283867|NCT00215683|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|5 years|The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.|||participants|||Number
1283868|NCT00215657|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).|||participants|||Number
1283869|NCT00215657|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A|||participants|||Number
1283870|NCT00215644|Secondary|Matuzumab Serum Concentration||Baseline up to approximately 3 years|Data for this outcome was not collected from any of the participant; hence, no data available for reporting.||||||
1283871|NCT00215644|Secondary|Percentage of Participants With Anti-Matuzumab Antibodies||Baseline up to approximately 3 years|Data for this outcome was not collected from any of the participant; hence, no data available for reporting.||||||
1283872|NCT00215644|Secondary|Protein Biomarkers Levels||Baseline up to approximately 3 years|Data for this outcome was not collected from any of the participant; hence, no data available for reporting.||||||
1283873|NCT00215644|Secondary|Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score|EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported.|Baseline (Day 1), Post Baseline (Up to 3 Years)|"ITT population. Here, overall number of participants analyzed = participants who were evaluable for this outcome and Number analyzed = participants evaluable for specified timepoint for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1283874|NCT00215644|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.|Baseline until death due to any cause (up to approximately 3 years)|ITT population.|||months||95% Confidence Interval|Median
1283875|NCT00215644|Secondary|Progression-Free Survival|PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.|Baseline up to PD or death due to any cause (up to approximately 3 years)|ITT population.|||months||95% Confidence Interval|Median
1283876|NCT00215644|Secondary|Duration of Objective Response Assessed by Independent Review Committee|Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: >25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.|From first documented objective response to PD or death due to any cause (up to approximately 3 years)|ITT population.|||months||95% Confidence Interval|Median
1283877|NCT00215644|Primary|Percentage of Participants With Objective Response Assessed by Independent Review Committee|Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.|Baseline up to PD or death due to any cause (up to approximately 3 years)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1283878|NCT00215553|Secondary|Days in ICU|Number of days in ICU|Through 28 days|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."|||days||Standard Deviation|Mean
1283879|NCT00215553|Secondary|Mortality||Through 28 days|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."|||participants|||Number
1283880|NCT00215553|Primary|Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.||Through 28 days|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."|||participants|||Number
1283881|NCT00215540|Secondary|Days in Hospital|The number of days spent in the hospital through 36 weeks PMA|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||days||Standard Deviation|Mean
1283882|NCT00215540|Secondary|Incidence of Death or BPD at 28 Days|Death or BPD, defined as oxygen requirement at 28 days of life|28 days of life|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
1283883|NCT00215540|Secondary|Area Under the Curve for Mean Arterial Pressure (MAP)|AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||arterial pressure (mm Hg)*hour||Standard Deviation|Mean
1283884|NCT00215540|Secondary|Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)|AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||Percent O₂*hour||Standard Deviation|Mean
1283885|NCT00215540|Secondary|Duration of Supplemental Oxygen|Number of days receiving supplemental oxygen through 36 weeks PMA|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||days||Standard Deviation|Mean
1283886|NCT00215540|Secondary|Days Receiving Mechanical Ventilation (MV)|Number of days receiving mechanical ventilation|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||days||Standard Deviation|Mean
1283887|NCT00215540|Secondary|BPD at 36 Weeks|BPD at 36 weeks PMA as determined by the need for supplemental oxygen|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
1283888|NCT00215540|Secondary|BPD at 28 Days|BPD at 28 days of life, as determined by the need for supplemental oxygen|28 days of life|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
1283889|NCT00215540|Primary|All-cause Mortality||36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
1283890|NCT00215540|Primary|Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks|Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age|36 weeks post-menstrual age (PMA)|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
1283908|NCT00214539|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months||||Percent Change||Standard Deviation|Mean
1283891|NCT00215150|Primary|Brief Social Phobia Scale(BSPS)|An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.|Baseline, 8 and 16 weeks|The number of participants evaluated in either phase is based on a last observation carried forward analysis requiring at least one visit completed in addition to the first timepoint.|||units on a scale||Standard Deviation|Mean
1283892|NCT00215137|Primary|Yale Brown Obsessive Compulsive Scale|The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.|Open Label Phase Baseline,Randomization Phase Baseline or Beginning||||units on a scale||Standard Deviation|Mean
1283893|NCT00214903|Primary|Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)|Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.|within 8.5 years|The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
1283894|NCT00214903|Primary|Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)|Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.|within 8.5 years|The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
1283895|NCT00214786|Secondary|The Quality of Life of the Recipients Measured With the RAND 36-item Short Form Health Survey|Averaged score in subscales of 'physical functioning', 'Role limitations due to emotional problems', 'energy/fatigue', 'emotional well-being', 'social functioning', 'pain' and 'general health' in the RAND 36-item short form health survey (SF-36). Full scale range is 0-100 for all subscales with 100 as the best outcome and 0 as the worst outcome.|12 months after transplantation||||Scores on a scale||Full Range|Median
1283896|NCT00214786|Secondary|Morbidity Related to the Islet Cell Infusion|Number of participants who experienced serious adverse events related to islet cell infusion|12months after transplantation||||participant|||Number
1283897|NCT00214786|Secondary|Morbidity Related to the Immunosuppression Regimen|Number of participants who experienced serious adverse events related to immunosuppression regimen|12 months after transplantation||||participant|||Number
1283898|NCT00214786|Secondary|Renal Function|Glomerular filtration rate measured by sodium iothalamate I-125 injection (GLOFIL)|12 months after transplantation||||ml/min||Standard Error|Mean
1283899|NCT00214786|Secondary|The Number of Islet Cell Infusions Needed to Achieve Insulin Independence||12 months after transplantation||||number of infusion||Standard Error|Mean
1283900|NCT00214786|Secondary|Islet Cell Mass Obtained After Remote Site Processing|The sum of Islet mass obtained after transport using the two-layer preservation method, remote site processing and islet culture. Islet mass as defined by Islet Equivalent per kilogram recipient body weight.|At transplantation||||Islet Equivalent per kilogram||Standard Error|Mean
1283901|NCT00214786|Secondary|Change of Insulin Requirements in Patients Who Did Not Become Insulin Independent|Percentage of insulin requirement at month 12 against that at baseline in the patients who did not achieve insulin independence. The percentage less than 100% indicates that subjects reduced insulin requirements 12 months after islet transplantation when compared with those at pre-transplant, while the parentage more than 100% represents that patients needed higher amount of exogenous insulin 12 months after islet transplantation.|12 months after transplantation||||Percent decrease compared to baseline||Standard Error|Mean
1283902|NCT00214786|Secondary|Incidence of Hypoglycemic Episodes|Blood glucose <70 mg/dl, number of times reported per month|12 months after transplantation||||episodes per month||Standard Error|Mean
1283903|NCT00214786|Secondary|Presence or Absence of Hypoglycemic Unawareness|Number of patients who achieved absence of hypoglycemic unawareness|12 months after transplantation||||participants|||Number
1283904|NCT00214786|Primary|Achievement of Insulin Independence at 12-month Post Transplant|To assess the number of patients who achieve insulin independence at 12-month after islet cell transplantation|12 months post transplant||||participant|||Number
1283905|NCT00214539|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Quality of Life Questionnaire (AQLQ) score. The AQLQ is a self-administered patient questionnaire that assesses four aspects or domains of daily life for patients with asthma: symptoms, emotional function, activity limitations, and environmental stimuli. The AQLQ is based on a 2-week recall period and consists of 32 questions, each scored from 1 (Worse) to 7 (Better). An increase in the AQLQ score indicates a better quality of life.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
1283906|NCT00214539|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Control Questionnaire (ACQ) score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). The ACQ is based on a one-week recall period. A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
1283907|NCT00214539|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months||||Percent Change||Standard Deviation|Mean
1283909|NCT00214539|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Total Symptom Score. The Total Symptom Score comprises the sum of six asthma symptom measurements recorded in a Daily Diary. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom Score represents better asthma control.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
1283910|NCT00214539|Secondary|Use of Rescue Medications (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in use of rescue medications. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months||||Puffs/7 Days||Standard Deviation|Mean
1283911|NCT00214539|Secondary|Use of Maintenance Medications (Change From Baseline)|Percent Change from Baseline at 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visit in dose of inhaled and/or oral corticosteroids.|Baseline, 12 Months||||Percent||Standard Deviation|Mean
1283912|NCT00214539|Primary|Respiratory Adverse Events Per Subject|Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.|Baseline, 12 Months||||Respiratory Adverse Events/Subject|||Number
1283913|NCT00214526|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Total Symptom Score. Total Symptom Score comprises the sum of six asthma symptom measurements. Each symptom is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
1283914|NCT00214526|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in AQLQ score. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). The AQLQ score is the mean of the scores from the 32 individual questions. An increase in the AQLQ score indicates a better quality of life. A within-subject change in score of 0.5 represents the minimal important difference (MID).|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
1283915|NCT00214526|Secondary|Use of Maintenance Medications (Change From Baseline)|Change from Baseline at 12-Months (OFF-LABA) Follow-up Visit in use of maintenance medications (inhaled corticosteroids and/or long-acting beta-agonists).|Baseline, 12 Months||||Subjects|||Number
1283916|NCT00214526|Secondary|Use of Rescue Medications (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in use of rescue medications (short acting bronchodilators) measured in puffs per week. Subjects recorded their use of rescue medication for asthma symptoms in their Daily Diary throughout the study.|Baseline, 12 Months||||Puffs/7 Days||Standard Deviation|Mean
1283917|NCT00214526|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Asthma Control Questionnaire (ACQ) Score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (best) to 6 (worst) and averaged, resulting in a total score from 0 to 6. A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
1283918|NCT00214526|Secondary|Peak Expiratory Flow (Morning and Evening) (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in morning and evening Peak Expiratory Flow (PEF). The peak expiratory flow rate measures the maximal rate at which a person can exhale air.|Baseline, 12 Months||||L/min||Standard Deviation|Mean
1283919|NCT00214526|Secondary|Methacholine PC20 (Change From Baseline)|"Change from Baseline at 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in PC20 - provocative concentration of Provocholine (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from baseline. The patient inhales an aerosol of one or more concentrations of methacholine. The lower the concentration of methacholine that provokes a 20% (or greater) fall in FEV1, the more “responsive” or “hyperresponsive” the airways are. Conversely, a rise in methacholine PC20 indicates airways that have become less reactive."|Baseline, 12 Months||||mg/mL||95% Confidence Interval|Geometric Mean
1283920|NCT00214526|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in post-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).|Baseline, 12 Months||||Percent Change||Standard Deviation|Mean
1283921|NCT00214526|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).|Baseline, 12 Months||||Percent Change||Standard Deviation|Mean
1283922|NCT00214526|Primary|Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)|Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.|Baseline, 12 Months||||Exacerbations/Subject/Week||Standard Deviation|Mean
1283942|NCT00214136|Secondary|To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival|Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals.|5 years|Data was not collected for this outcome measure. Results can not be reported or analyzed.||||||
1283923|NCT00214500|Secondary|α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96|Leukocytes were isolated from whole blood and lysed, and α-Gal A activity was measured using a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole [nmol] 4-MU/hr) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat. α-Gal A activity in leukocytes are presented by individual participants.|Baseline, Week 12 (end of treatment period), Week 96 (end of extension period)|PD Population: all eligible-enrolled participants who received at least 1 dose of study drug on Day 1, and who had a non-missing baseline and at least 1 non-missing postbaseline PD parameter recorded. Participants who discontinued prior to the specified time point were not analyzed because no data were available.|||nmol 4-MU/hr/mg protein|||Number
1283924|NCT00214500|Secondary|PK: Area Under The Concentration Versus Time Curve (AUC) After Administration Of Migalastat|The AUC from time zero to 12 hours (hr) postdose (AUC0-12) was evaluated in plasma following a single dose of migalastat 25, 100, and 250 mg on Days 1, 15, and 29, respectively. In addition, AUC0-12 was assessed following multiple doses (14 days) of migalastat 25, 100, and 250 mg on Days 14, 28, and 42, respectively.|0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, and 10 hr (postdose)|PK Population: all eligible-enrolled participants who received study drug and had at least 1 postbaseline PK parameter recorded. One participant discontinued prior to receiving doses of migalastat 100 and 250 mg.|||nanograms*hr/milliliters (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1283925|NCT00214500|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 96 is presented. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Week 96|Safety Population: all eligible-enrolled participants who received at least 1 dose of study drug. 6 participants were dosed screen failures, and were not included in the safety analysis.|||Participants|||Count of Participants
1283926|NCT00214487|Secondary|Changes in Axial Length at One Year.||One year|||||||
1283927|NCT00214487|Secondary|Changes in Cycloplegic Subjective Refraction in One Year||One year|||||||
1283928|NCT00214487|Secondary|Relationship Between Residual Fixation Disparity and Myopia Progression.||One year|||||||
1283929|NCT00214487|Secondary|Changes in Manifest Refraction at One Year.||One year|||||||
1283930|NCT00214487|Secondary|Keratometric Changes at One Year.||One year|||||||
1283931|NCT00214487|Primary|Changes in Cycloplegic Autorefraction in One Year.||One year||||Diopters||Standard Deviation|Mean
1283932|NCT00214461|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.||Day 0 to up to 70 days post first vaccination|Safety assessments were on the safety population.|||Participants|||Number
1283933|NCT00214461|Secondary|Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.|Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject’s specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).|Day up to Day 236 post first vaccination|Serum anti-toxin levels were assessed in the fully evaluable (Per-Protocol) population.|||Participants|||Number
1283934|NCT00214383|Secondary|Improvement in Asthma Control|A six item survey on a seven point Likert scale measuring daytime and nocturnal asthma symptoms, missed school days and rescue medication use in the previous seven days. Lower scores signal better asthma control.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.|||Likert scale||95% Confidence Interval|Mean
1283935|NCT00214383|Primary|Number of Symptom-free Days|A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.|||Days||95% Confidence Interval|Mean
1283936|NCT00214383|Primary|Percentage Changed in Adherence Score|A baseline number of participants less dropouts was gauged against the weighted average of the number of participants in study period. The percentage change in adherence from baseline through the study was measured and is reported below, together with confidence intervals.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.|||Percent change||95% Confidence Interval|Mean
1283937|NCT00214201|Other Pre-specified|WBC|White Blood Cell count|36 months +/- 60 days||||K/ul||Standard Deviation|Mean
1283938|NCT00214201|Secondary|Serum Creatinine at 36 Months (End of Study)||36 months +/- 60 days||||mg/dl||Standard Deviation|Mean
1283939|NCT00214201|Primary|Number of Participants With Biopsy Proven Rejection||3 years||||participants|||Number
1283940|NCT00214149|Secondary|To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years||3 years|No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.||||||
1283941|NCT00214149|Primary|To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT||5 years|No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.||||||
1283960|NCT00212446|Secondary|The Length of NICU Stay|The length of Neonatal intensive care unit (NICU) stay|up to one month||||days||Standard Deviation|Mean
1283943|NCT00214136|Primary|Number of Participants Experiencing Expected Toxicities|Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.|Up to 5 years|Only 25 of 30 participants met the minimum follow up thresholds at the time of analysis; the 5 most recently accrued participants' data was not analyzed and is not reflected.|||Participants|||Count of Participants
1283944|NCT00214019|Primary|Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge|Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.|Eosinophils are measured 24 hours after the subject has an antigen challenge|Participants for analysis included any subject that completed that specific treatment phase, even if they did not complete other treatment phases.|||Eosinophil percentage||Standard Deviation|Mean
1283945|NCT00213980|Secondary|Clinical Toxicity of ZA|Tolerability and side effects of ZA, measured by the number of participants experiencing adverse events.|Up to 1 year|Data was collected for the ZA arm at 9 time points, and for the Observation arm at 2 time points.|||Participants|||Count of Participants
1283946|NCT00213980|Secondary|Overall Survival|Number of participants who survived from the start of treatment through off treatment, up to 10 years.|Up to 10 years|Only participants who completed the trial (ZA = 29 and Observation = 26) were analyzed for this outcome measure.|||Participants|||Count of Participants
1283947|NCT00213980|Secondary|Rates of Metastases|Determine whether zoledronate is associated in rates of bone, visceral, and all distant metastases.|Up to 1 year|Data for this outcome measure was not collected.||||||
1283948|NCT00213980|Primary|Change in Bone Mineral Density (BMD) From Baseline to 1 Year|To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with increases in bone mineral density at the lumbar spine and femoral head, calculated from baseline and 1 year data. Participants who missed one or more DXA were not evaluated.|Up to 1 year|Fifty-six participants (ZA = 29, Observation = 27) were evaluable based on completing DXAs at 0, 6, and 12 months.|||grams per cubic centimeter||95% Confidence Interval|Mean
1283949|NCT00213239|Secondary|Incidence of Adverse Events.||Followed for the length of the procedure.||||Participants|||Count of Participants
1283950|NCT00213239|Primary|Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion|Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion|Movement measured at the time of lumbar puncture needle insertion.|Minimum effective dose of remifentanil to prevent movement during lumbar puncture insertion|||micrograms/kg||Standard Deviation|Mean
1283951|NCT00213148|Secondary|Number of Subjects With Clinical Pregnancy in Cycle 1|Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.|Up to 1 month|All Treated population included all treated subjects who received at least one tablet of study drug (CC or anastrozole).|||subjects|||Number
1283952|NCT00213148|Primary|Ovulation Rate in Cycle 1|Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy).|Up to 1 month|All Treated population included all treated subjects who received at least one tablet of study drug (clomiphene citrate or anastrozole).|||percentage of subjects|||Number
1283953|NCT00213135|Secondary|Mean Number of Combined Unique (CU) Lesions, Active Time Constant 2 (T2) Lesions, and Active Time Constant 1 (T1) Gadolinium-Enhanced (Gd+) Lesions Per Participant Per Scan|Mean Number of CU lesions, active T2 lesions, and active T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all participants who were randomized in the study.|||lesions||Standard Error|Least Squares Mean
1283954|NCT00213135|Secondary|Time to Disability Progression|Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Tenth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.|Baseline up to Week 96|The ITT population included all participants who were randomized in the study.|||months|||Number
1283955|NCT00213135|Secondary|Percentage of Relapse-free Participants|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the EDSS or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Week 96|The ITT population included all participants who were randomized in the study.|||percentage of participants|||Number
1283956|NCT00213135|Primary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Week 96|The intention-to-treat (ITT) population included all participants who were randomized in the study.|||relapses per year||95% Confidence Interval|Number
1283957|NCT00212758|Secondary|Change in Height at 56 Weeks||week 1, week 56||||cm||Standard Deviation|Mean
1283958|NCT00212758|Primary|The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)|We will measure the amount of serum IGF-I generated after 7 days of growth hormone therapy (Day8-Day1).|Day 1 & Day 8||||mcg/L||Standard Deviation|Mean
1283959|NCT00212446|Secondary|Gestational Age at Discharge|Gestational age at discharge.|until after childbirth||||weeks||Standard Deviation|Mean
1283961|NCT00212446|Secondary|Apgars Score|"The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.~Five factors: Appearance (skin color), Pulse (heart rate), Grimace response (reflexes), Activity (muscle tone), Respiration (breathing rate and effort) are used to evaluate the baby's condition and each factor is scored on a scale of 0 to 2, with full scale from 0 to 10 being the best score"|1 minute and 5 minute after childbirth||||units on a scale||Standard Deviation|Mean
1283962|NCT00212446|Secondary|Pain During the Birthing Process||Until birthing process is complete|not collected||||||
1283963|NCT00212446|Secondary|Latency of Birth|Latency is defined as the time from admission into hospital until birth|Time until delivery, up to 4 weeks||||hours||Standard Deviation|Mean
1283964|NCT00212446|Primary|Number of Newborn With Fetal Heart Arrhythmias|Number of newborn with fetal heart arrhythmias noted|60 minutes||||newborns with fetal heart arrhythmias|||Number
1283965|NCT00212446|Primary|Uterine Contractions|The first 20 minutes are the control contraction period (C1). The second 20 minutes are the EI period, with a 10-second burst of current administered just prior to each expected contraction; expected contractions are determined by the timing of the C1 contractions and/or by the rise of the subjective tocodynamometer tracing above baseline levels. The third 20 minutes is the post-intervention control contraction period (C2).|20 minutes, 40 minutes, 60 minutes||||minutes||Standard Deviation|Mean
1283966|NCT00212355|Primary|Safety|No of patients who have at least one adverse events.|During study period (up to 96W )|The analysis was performed based on FAS population|||participants|||Number
1283967|NCT00212264|Primary|Percent Change in Incontinence Episodes Per Week on Bladder Diary|[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%|1 year|This outcome was to measure treatment durability. The no-treatment control group completed the study after the primary outcome was collected at 2 months. At that time, they were offered treatment for this burdensome condition outside the study. Only the 2 active treatment groups continued in the study for 1 full year.|||% change in episodes per week||95% Confidence Interval|Mean
1283968|NCT00212264|Primary|Percent Change in Incontinence Episodes on Bladder Diary|[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100%|2 months||||% change in episodes per week||95% Confidence Interval|Mean
1283969|NCT00212134|Secondary|Parenting Stress|The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252|Phase 1 - Age 12 Months|All those who completed the PSI 3 months after surgery and the PSI at age 12 months|||units on a scale||Standard Deviation|Mean
1283970|NCT00212134|Secondary|Adherence to Occlusion Therapy|Parental report of the number of hours children wore an patch to occlude the fellow eye.|Phase 1 - 12 months follow-up|Analysis is limited to those with at least 3 reports of adherence before 12 months of age.|||Hours patched per day||Standard Deviation|Mean
1283971|NCT00212134|Secondary|Parenting Stress|The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252.|Phase 1 - 3 months post surgery|All those who completed the PSI 3 months after surgery.|||units on a scale||Standard Deviation|Mean
1283972|NCT00212134|Secondary|Percent of Patients With 1 or More Adverse Events||Study enrollment to age 5 years||||percentage of patients||95% Confidence Interval|Number
1283973|NCT00212134|Secondary|Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery|Percent of Patients with 1 or More Intraoperative Complications at Cataract Surgery|Cataract surgery immediately after enrollment||||percentage of patients||95% Confidence Interval|Number
1283974|NCT00212134|Primary|Visual Acuity - Subjective Assessment at Age 10 Years.|Visual acuity assessment using the E-ETDRS protocol will be performed by certified site personnel; patients should be in their best optical correction as determined by the PI either recently or just before the EVA test|Phase 3 Age 10 Years||2019-03-31|03/2019||||
1283975|NCT00212134|Primary|Visual Acuity - Subjective Assessment at Age 4.5 Years.|Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel.|Phase 2 - Age 4.5 Years|One patient in the intraocular lens group was lost to follow-up.at age 18 months. A second patient in that group had developmental delay and the visual acuity could not be assessed. Therefore, the visual acuity measurements at 4.5 years of age are reported for 55 of the 57 patients randomized to the intraocular lens group.|||logMAR units||Inter-Quartile Range|Median
1283976|NCT00212134|Primary|Visual Acuity|Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units.|Phase 1 - Age 12 months|The number of participants was determined by the sample size estimate necessary to detect a 0.2 logMAR difference (2 lines on the Snellen chart) in the visual acuity between the two groups.|||logMAR units||Inter-Quartile Range|Median
1283990|NCT00211692|Secondary|Participants Achieving SVR Categorized by Time of Response|rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks|24 weeks after end of treatment|participants with analyzable data for this outcome|||participants|||Number
1283977|NCT00211887|Secondary|Change in MRI Composite Score|MRI composite score (Z4 score) - the unweighted sum of the individual Z scores for enhanced tissue volume, T2 lesion burden, equivalence of the T1 hypointense lesion burden, normalized CSF (an inverse measure of atrophy with the appropriate sign so that all scores are directionally compatible – larger is worse) MRI enhancement status at baseline (0, 1-4, and 5 or more enhancing lesions)|Baseline to month 36|Due to participant dropouts, there were less participants analyzed for this particular outcome measure.|||z score||Standard Deviation|Mean
1283978|NCT00211887|Secondary|Change in the Multiple Sclerosis Functional Composite|"positive indicates improvement~The Multiple Sclerosis Functional Composite (MSFC) is a scale measuring pyramidal functions, sensory functions, cerebellar functions, bowel & bladder functions,brain stem functions, mental functions, and visual functions from 0 to 6.~0= normal 6= severe loss"|Baseline to month 36|Due to participant dropouts, there were less participants analyzed for this particular outcome measure.|||units on a scale||Full Range|Median
1283979|NCT00211887|Secondary|Confirmed Progression on the Expanded Disability Status Scale|"% with EDSS progression~Confirmed progression in a participant was defined as a 1.0 increase in the EDSS from baseline, when baseline <=5.0; or an increase of 0.5 from baseline, when baseline >=5.5, sustained for 6 months (2 successive quarterly visits), as assessed by the blinded EDSS examiner and confirmed centrally."|Baseline to Month 36||||percentage of participants|||Number
1283980|NCT00211887|Primary|ARR - PDEs|Annualized relapse rate of protocol-defined exacerbations Protocol defined relapse – an relapse seen within 7 days of onset, verified by the treating physician and independently observed as a change in EDSS by the examining physician. This relapse is defined as: the appearance of a new symptom or worsening of an old symptom, attributable to MS; accompanied by a change in the neurologic examination (defined as a 0.5 or greater increase in the EDSS over the last scheduled or unscheduled visit or a 2 point change in one functional system or a 1 point change in two functional systems, except bladder and cognitive changes); lasting at least 24 hours in the absence of fever; and preceded by stability or improvement for at least 30 days.|Baseline to Month 36||||relapses per year|||Number
1283981|NCT00211809|Secondary|Beck Anxiety Inventory|The Beck Anxiety Inventory (BAI) is a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.|Baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
1283982|NCT00211809|Secondary|Beck Depression Inventory II|The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.|Baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
1283983|NCT00211809|Secondary|Brown Assessment of Beliefs Scale|The Brown Assessment of Beliefs Scale (BABS) rates the degree of conviction and insight patients have concerning their beliefs. The BABS consists of 7 items: the first 6 items are added to obtain the total BABS score. An additional item (ideas of reference) is not included in the total score. Scoring is from 0 (least severe) to 4 (most severe), with total score from 0 to 24.|Baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
1283984|NCT00211809|Primary|Body Dysmorphic Disorder Clinical Global Impressions Scale|The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
1283985|NCT00211809|Primary|Yale Brown Obsessive Scale|Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content.|baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
1283986|NCT00211809|Primary|Body Dysmorphic Disorder Examination|Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.|baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
1283987|NCT00211757|Primary|Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores|The Aberrant Behavior Checklist is designed to objectively identify five behavior sub scales through observation by the primary caregiver: irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech. The ABC was filled out by parents on a scale from 0-3 for each category. (0 being not a problem, 3 being severe problem). Scores from all sub scales were added (scoring 0-45 for Irritability subscale, 0-48 for Lethargy subscale, 0-21 for stereotypy scale, 0-48 for hyperactivity sub-scale, and 0-12 for inappropriate speech sub-scale) to obtain a total score.|Baseline and End of Study (week 15)||||units on a scale||Standard Deviation|Mean
1283988|NCT00211757|Primary|Number of Participants Reporting Improvement on the Clinical Global Impression|The CGI-I is a 7-point improvement scale. Ratings of 1 or 2 (responders) indicate a substantial reduction in symptoms. A rating of 3 (minimally improved) on the CGI is defined as a slight symptomatic improvement that is not deemed clinically significant; patients with such an improvement were not considered responders. Two versions of this test were used, one focused on irritability (primary outcome measure) and a general version CGI-I-autism focused on all symptoms including core symptom domains. The CGI-I irritability took into consideration the scores from the ABC-Irritability subscale, the OAS-M aggression and irritability subscales and information from open-ended questioning related to the degree of interference, nature, and range of behavioral problems at school and at home|Baseline to end of study (week 15)||||Participants|||Count of Participants
1283989|NCT00211692|Secondary|Overall Number of Serious Adverse Events||through end of study up to 72 weeks||||participants|||Number
1283992|NCT00211692|Primary|The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.|Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study|24 weeks after the end of treatment|Convenience sample for pilot trial. Analysis is intention to treat.|||participants|||Number
1283993|NCT00211536|Secondary|Low Blood Glucose Index (LBGI);|4 to 10 daily blood glucose readings (BG) were required for this measure. LBGI was calculated from BG values collected for 30 days prior to Visit 2 and 30 days following Visits 5 and 7. The continuous measure was compared between the two treatment groups for the three periods with a repeated measures ANOVA using proc mixed. Type 3 least square means for each group were assessed and estimate statements used to make comparisons among the LS means and create confidence intervals on the contrasts.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.|||mg/dL||95% Confidence Interval|Mean
1283994|NCT00211536|Secondary|Mean Amplitude of Glycemic Excursions (MAGE)|MAGE was calculated by taking the arithmetic mean of BG excursions when both ascending and descending segments of the curve exceed one Standard Deviation of the average 24-hour BG value. MAGE was calculated for each subject using SMBG data from periods in which subjects had a minimum of 4 and maximum of 10 readings daily. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.|||mg/dL||95% Confidence Interval|Mean
1283995|NCT00211536|Secondary|Average Daily Blood Glucose|For each subject, a minimum of two blood glucose readings per day was required for calculation of the average daily mean. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.|||mg/dL||95% Confidence Interval|Mean
1283996|NCT00211536|Primary|Incidence of Severe Hypoglycemia Events|The total number of severe hypoglycemia events, defined as a clinical episode of hypoglycemia (resulting in seizure or coma, requiring hospitalization, intravenous glucose or glucagon administration), or any hypoglycemia that requires assistance from another person, compared between the two study arms from Baseline to 12 months.|12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.|||events|||Number
1283997|NCT00211536|Primary|Change in HbA1c and Compared Between Groups|To determine whether Intra Peritoneal insulin delivery via MIP results in glycemic control that is equal to or superior (i.e. not inferior to) control with SC therapy (Ho : μ (IP) -μ (SC) ≥ 0.50% A1C), a repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed was used to compare average A1C trends over time between the two treatment groups (19). Type 3 Least Square (LS) means for each group were assessed. The Estimate statement within SAS proc mixed was used to estimate contrasts among the LS means and confidence intervals for the contrasts.|Baseline and 12 months|The primary efficacy analysis set is the As treated data set and includes all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values.|||percent HbA1c||Standard Deviation|Mean
1283998|NCT00211510|Secondary|Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups|Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.|Baseline and 26 weeks||||Scores on a scale||Standard Deviation|Mean
1283999|NCT00211510|Secondary|Glucose Sensor Accuracy as Measured in the 722 Group|Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).|Baseline and 26 weeks||||percent of agreement|||Number
1284000|NCT00211510|Secondary|Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26|Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26|Baseline and 26 weeks||||mmol/dl*min||Standard Deviation|Mean
1284001|NCT00211510|Secondary|Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26|Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26|Baseline and 26 weeks||||mmol/dl*min||Standard Deviation|Mean
1284002|NCT00211510|Secondary|Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26|Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.|Baseline and 26 weeks||||hypoglycemic events|||Number
1284003|NCT00211510|Primary|Change in A1c From Baseline to 26 Weeks|Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.|Baseline and 26 weeks||||Percent glycated hemoglobin||Standard Deviation|Mean
1284070|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
1284004|NCT00211237|Secondary|Rate of Subsequent Vertebral Body Fractures|Based on patients with at least 7 analyzable vertebrae.|1 month and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
1284005|NCT00211237|Secondary|Rate of Subsequent Vertebral Body Fractures||1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
1284006|NCT00211237|Secondary|Rate of Study Treatment-related Adverse Events Till Study Completion|"The study treatment-related AEs were defined as follows:~Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.~Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.~Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.~Unknown defined as the relationship of the AE to a Sponsor device could not be determined."|12 months|All of randomized subjects were included in safety population analysis.|||percentage of participants|||Number
1284007|NCT00211237|Secondary|Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline|"The study treatment-related AEs were defined as follows:~Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.~Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.~Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.~Unknown defined as the relationship of the AE to a Sponsor device could not be determined."|1 month|All of the randomized subjects were included in safety population analysis.|||percentage of participants|||Number
1284008|NCT00211237|Secondary|Change in Neurological Status From Baseline (Limb Strength)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
1284009|NCT00211237|Secondary|Change in Neurological Status From Baseline (Limb Strength)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
1284010|NCT00211237|Secondary|Change in Neurological Status From Baseline (Reflex Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:~absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3"|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
1284011|NCT00211237|Secondary|Change in Neurological Status From Baseline (Reflex Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:~absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3"|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
1284012|NCT00211237|Secondary|Change in Neurological Status From Baseline (Sensory Examination)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
1284013|NCT00211237|Secondary|Change in Neurological Status From Baseline (Sensory Examination)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
1284035|NCT00211237|Secondary|Change in Functional Status Assessed With the Karnofsky Performance Scale|The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||units on a scale||Standard Deviation|Mean
1284014|NCT00211237|Secondary|Change in Neurology Status From Baseline (Motor Strength)-Per Protocol|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:~absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5"|1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
1284015|NCT00211237|Secondary|Change in Neurology Status From Baseline (Motor Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:~absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5"|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
1284016|NCT00211237|Secondary|Back Pain Analgesics Used||Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
1284017|NCT00211237|Secondary|Back Pain Analgesics Used||Baseline, 7 days, and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
1284018|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.|Baseline, post-operation, 1 month, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||ratio||Standard Deviation|Mean
1284019|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||ratio||Standard Deviation|Mean
1284020|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Angles|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.|Baseline, post-operation, 1 month, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||degrees||Standard Deviation|Mean
1284021|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||degrees||Standard Deviation|Mean
1284022|NCT00211237|Secondary|Ambulatory Status Change|Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.|Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
1284023|NCT00211237|Secondary|Ambulatory Status Change From Baseline to One Month|Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
1284024|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||days||Standard Deviation|Mean
1284025|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||days||Standard Deviation|Mean
1284026|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||days||Standard Deviation|Mean
1284027|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||days||Standard Deviation|Mean
1284028|NCT00211237|Secondary|Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
1284029|NCT00211237|Secondary|Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
1284030|NCT00211237|Secondary|Change in Quality of Life|The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||units on a scale||Standard Deviation|Mean
1284031|NCT00211237|Secondary|Change in Quality of Life.|The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||units on a scale||Standard Deviation|Mean
1284032|NCT00211237|Secondary|Change in Back Pain|Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||units on a scale||Standard Deviation|Mean
1284033|NCT00211237|Secondary|Change in Back Pain|Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||units on a scale||Standard Deviation|Mean
1284034|NCT00211237|Secondary|Change in Functional Status Assessed With the Karnofsky Performance Scale|The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||units on a scale||Standard Deviation|Mean
1284071|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
1284036|NCT00211237|Secondary|Change in Roland-Morris Disability Questionnaire Score|Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||units on a scale||Standard Deviation|Mean
1284037|NCT00211237|Primary|The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month|"The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain.~The best score is 0 (no disability) and worst is 24 (maximum disability)"|Baseline and 1 Month|The analyses of change from Baseline included only patients in the modified Intent-to-Treat (mITT) population who provided evaluable data at both Baseline and at 1 month after receipt of the initially assigned study treatment.|||score on a scale||95% Confidence Interval|Mean
1284038|NCT00211172|Primary|Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date|The primary outcome measure adherence to B-blocker therapy post intervention. Adherence was measured by the degree of prescription filling in an interval derived from pharmacy prescription records by constructing a proportion-of-days-covered per-month measure, using the quantity dispensed and days supplied from each prescription|9 months||||Adjusted monthly % of days covered||Standard Deviation|Mean
1284039|NCT00211081|Secondary|Change in 6 Minute Walk Test Score||Baseline, Post-Intervention (4 Weeks)|This assessment was not completed during the study.||||||
1284040|NCT00211081|Secondary|Tumor Necrosis Factor-Alpha (TNF-a) Level|The normal result for TNF-a is <5.6 pg/mL.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||pg/mL||Inter-Quartile Range|Median
1284041|NCT00211081|Secondary|Interleukin-10 (IL10) Level|The normal result for IL-10 for Interleukin 10 is < 18pg/ml.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||18pg/ml||Inter-Quartile Range|Median
1284042|NCT00211081|Secondary|Interleukin 1 Beta (IL1b) Level|The normal result for IL1b is <3.9 pg/mL.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||pg/mL||Inter-Quartile Range|Median
1284043|NCT00211081|Secondary|Interleukin-6 (IL-6) Level|The normal result for IL-6 for Interleukin 6 is < 5pg/ml.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||pg/ml||Inter-Quartile Range|Median
1284044|NCT00211081|Secondary|C-Reactive Protein Level|The normal reference range for C-reactive protein is as follows: CRP: 0-10mg/L|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||mg/L||Inter-Quartile Range|Median
1284045|NCT00211081|Primary|Change in Flow Mediated Dilation|Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||Percentage of brachial artery diameter||Standard Deviation|Mean
1284046|NCT00210639|Primary|Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase|The criteria used to assess Musculoskeletal Adverse Event is based on system organ class “Musculoskeletal and connective tissue disorders” of MedDRA 13.0.|Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)|Participants (207) who were followed up during the MSD Follow-Up Phase.|||Participants|||Number
1284047|NCT00210626|Secondary|Return to Usual Activity (RTUA)|Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized.|Hospital Discharge to Post-Hospital Discharge Week 24|Intention to Treat(ITT)population and completed Week 24 Post-Hospital discharge.|||Participants|||Number
1284048|NCT00210626|Primary|SF-36 PF Score|Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.|Hospital Discharge to Post-Hospital Discharge Week 24|ITT (Intent to Treat), The number of subjects analyzed includes all ITT subjects that did not withdraw from the study prior to hospital discharge.|||Units on a scale.||Standard Deviation|Mean
1284049|NCT00210470|Secondary|Correlation of Tumor Response or Immune Competence (Lymphocyte Infiltration) With Disease-Free Survival or Overall Survival|Investigate whether clinical or histological tumor response or improvement in immune competence correlate with DFS and OS|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||2012-09-30|09/2012||||
1284050|NCT00210470|Secondary|Overall Survival|Estimate overall survival (OS) in patients receiving the IRX-2 regimen|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||2012-09-30|09/2012||||
1284051|NCT00210470|Secondary|Disease-free Survival|Estimate disease-free survival (DFS) (defined as time from cyclophosphamide administration and time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy; margins of resection positive for tumor will not be considered disease recurrence)|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||2012-09-30|09/2012||||
1284052|NCT00210470|Secondary|Immune Competence as Measured by Lymphocyte Infiltration|To assess measures of immune competence following administration of the IRX-2 regimen, including total lymphocyte count, peripheral T-cell count and subpopulation studies, and skin test reactivity|At approx. 21 days, prior to surgery||2012-09-30|09/2012||||
1284053|NCT00210470|Secondary|Evaluate Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;||Following surgery and post-operative therapy||2012-09-30|09/2012||||
1284054|NCT00210470|Secondary|Clinical and Histological Tumor Responses||At approx. 21 days, prior to surgery||2012-09-30|09/2012||||
1284127|NCT00209339|Secondary|Contrast Volume|Mean contrast volume utilized during the MitraClip procedure.|At day 0 (on the day of index procedure)|Contrast volume was not recorded in one patient. Therefore, contrast volume data is available for 54 of the 55 patients.|||Milliliters||Standard Deviation|Mean
1284055|NCT00210470|Primary|Number of Participants With Adverse Events and Serious Adverse Events|The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described. The number of deaths during study and their relatedness (or not) to treatment, as well as changes in laboratory measures, were published (see referenced publication for details: Wolf, 2011).|Enrollment through 30 days post-surgery|"27 participants were entered into study and treated. All participants were included in the safety analysis.~Based on safety results, the treatment regimen was tolerated. Further clinical study was recommended to evaluate efficacy."|||participants|||Number
1284056|NCT00209560|Secondary|Time to Fully Alert From the End of the Procedure|Time to Fully Alert, defined as the time to the first of 3 consecutive Modified OAA/S scores of 5 from the end of the surgical procedure, was summarized.|At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status|The primary analysis for the secondary efficacy endpoint was based on the mITT population. Missing values or incomplete data were not imputed.|||minutes||Standard Deviation|Mean
1284057|NCT00209560|Primary|Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation|"The Modified OAA/S (MOAA/S) scale is based on a validated, 6-point rating scale. Scores are not combined.~Score 5 (alert) -- responds readily to name spoken in normal tone Score 4 -- Lethargic response to name spoken in normal tone Score 3 -- Responds only after name is called loudly and/or repeatedly Score 2 -- Responds only after mild prodding or shaking Score 1 -- Responds only after painful trapezius squeeze Score 0 -- Does not respond to painful trapezius squeeze"|Sedation success was assessed at 2 minute intervals until the end of the procedure|The pP1 and mITT population included all subjects randomized,received either fospropofol disodium or midazolam, had at least 1 postdose clinical assessment, and were not terminated due to the Investigator’s decision for nonstudy drug related findings. A 95% confidence interval for the sedation success rate was calculated for each treatment group.|||participants||95% Confidence Interval|Number
1284058|NCT00209417|Secondary|Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.|"Overall Image Quality rated as Excellent, Good, Sufficient or Insufficient Poor by radiologists blinded to the contrast administration."|Within 2, 3 and 7 days post contrast administration.||||Number of images|Participants||Number
1284059|NCT00209417|Primary|Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.|"The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL).~Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction."|From baseline up to 3 days post contrast administration.|To calculate the incidence rate of CIN, divide the number of subjects affected by the total number of subjects dosed in each treatment group.|||percentage of subjects||95% Confidence Interval|Number
1284060|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|60 months|"NYHA functional class was evaluated in 15 patients at the 48-month follow-up visit. NYHA assessment is missing in 40 patients due to:~30 withdrawals~4 deaths~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
1284061|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|48 months|"NYHA functional class was evaluated in 19 patients at the 48-month follow-up visit. NYHA assessment is missing in 36 patients due to:~23 withdrawals~3 deaths~1 missed visit~3 NYHA assessments not done~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
1284068|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Baseline||||participants|||Number
1284062|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 months|"NYHA functional class was evaluated in 21 patients at the 36-month follow-up visit. NYHA assessment is missing in 34 patients due to:~19 withdrawals~2 deaths~3 missed visits~4 NYHA assessments not done~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
1284063|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|"NYHA functional class was evaluated in 28 patients at the 24-month follow-up visit. NYHA assessment is missing in 27 patients due to:~18 withdrawals~2 deaths~1 missed visit~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
1284064|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|18 months|"NYHA functional class was evaluated in 27 patients at the 18-month follow-up visit. NYHA assessment is missing in 28 patients due to:~15 withdrawals~2 deaths~5 missed visits~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
1284065|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|"NYHA functional class was evaluated in 39 patients at the 12-month follow-up visit. NYHA assessment is missing in 16 patients due to:~8 withdrawals~1 death~NYHA assessment not done in 1 patient~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
1284066|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|"NYHA functional class was evaluated in 47 patients at the 30-day follow-up visit. NYHA assessment is missing in 8 patients due to:~2 withdrawals~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
1284067|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|"NYHA functional class was evaluated in 41 patients at the 6-month follow-up visit. NYHA assessment is missing in 14 patients due to:~7 withdrawals~1 death~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
1284072|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
1284073|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
1284074|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
1284075|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
1284076|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
1284077|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
1284078|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
1284079|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
1284080|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
1284081|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
1284082|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
1284083|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
1284084|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284085|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284086|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284087|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT~PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284088|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284089|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284090|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284091|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284092|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284093|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
1284094|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284095|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284096|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284097|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284098|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284099|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284100|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284101|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284102|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284103|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
1284104|NCT00209339|Secondary|Other Secondary Safety Events|Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).|Through 6 months||||percentage of participants|||Number
1284105|NCT00209339|Secondary|Other Secondary Safety Events|Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).|Through 30 days||||percentage of participants|||Number
1284106|NCT00209339|Secondary|Major Vascular and Bleeding Complications|Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure|Through 6 Months||||percentage of participants|||Number
1284107|NCT00209339|Secondary|Major Vascular and Bleeding Complications|Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure|Through 30 days||||percentage of participants|||Number
1284108|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 5 years||||Percentage of participants||95% Confidence Interval|Number
1284109|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 4 years||||Percentage of participants||95% Confidence Interval|Number
1284110|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 3 years||||Percentage of participants||95% Confidence Interval|Number
1284111|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 24 months||||Percentage of participants||95% Confidence Interval|Number
1284112|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 12 months||||Percentage of participants||95% Confidence Interval|Number
1284113|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||Within 30 days of the procedure||||Percentage of participants|||Number
1284114|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 5 Years||||Percentage of participants||95% Confidence Interval|Number
1284115|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 4 Years||||Percentage of participants||95% Confidence Interval|Number
1284116|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 3 Years||||Percentage of participants||95% Confidence Interval|Number
1284117|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 24 months||||Percentage of participants||95% Confidence Interval|Number
1284118|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 12 months||||Percentage of participants||95% Confidence Interval|Number
1284119|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At baseline||||Percentage of participants|||Number
1284120|NCT00209339|Secondary|MitraClip Device Embolizations and Single Leaflet Device Attachment|MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device.|Post index procedure through 5 years|Of the 55 patients enrolled in the EVEREST I study, 6 patients did not have a MitraClip device implanted.|||Participants|||Number
1284121|NCT00209339|Secondary|Second Intervention to Place a Second MitraClip Device||Post index procedure through 5 years||||Participants|||Number
1284122|NCT00209339|Secondary|Post-procedure Hospital Stay||Post-index procedure until hospital discharge (1 to 19 days)||||Days||Standard Deviation|Mean
1284123|NCT00209339|Secondary|Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration||Post index procedure within 30 days||||Hours||Standard Deviation|Mean
1284124|NCT00209339|Secondary|Intra-procedural Major Adverse Events|Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure|At day 0 (on the day of index procedure)||||percentage of participants|||Number
1284125|NCT00209339|Secondary|Number of Mitraclip Devices Implanted||At day 0 (on the day of index procedure)||||Percentage of participants|||Number
1284126|NCT00209339|Secondary|Fluoroscopy Duration|Mean fluoroscopy duration during the MitraClip procedure.|At day 0 (on the day of index procedure)|Mean fluoroscopy duration was not recorded in one patient. Therefore, mean fluoroscopy data is available for 54 of the 55 patients.|||Minutes||Standard Deviation|Mean
1284129|NCT00209339|Secondary|Procedure Time|"Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours.~The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device."|At day 0 (on the day of index procedure)||||Minutes||Standard Deviation|Mean
1284130|NCT00209339|Primary|Major Adverse Events (MAE)|Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.|Through 6 Months||||Percentage of participants|||Number
1284131|NCT00209339|Primary|Major Adverse Events (MAE)|Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.|Through 30 days||||Percentage of participants|||Number
1284132|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 5 years|Of total 55 patients population 15 patients were analysed, as 40 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
1284133|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 4 years|Of total 55 patients population 19 patients were analysed, as for 4 patients Echocardiogram was not performed and 32 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
1284134|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 3 years|Of total 55 patients population 23 patients were analysed, as for 5 patients Echocardiogram was not performed and 27 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
1284135|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 24 months|Of total 55 patients population 28 patients were analysed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
1284136|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 12 months|Of total 55 patients population 39 patients were analyzed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
1284137|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At discharge or within 30 days of the procedure|Based on the number of patients who have not died or withdrawn, and have reached the scheduled visit window|||Percentage of participants|||Number
1284138|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At baseline|Of total 55 patients,for 1 patient Echocardiogram was not evaluable.|||Percentage of participants|||Number
1284139|NCT00209274|Secondary|Number of Participants With Incidence of Mitral Valve Replacement||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284140|NCT00209274|Secondary|Number of Participants With Incidence of Mitral Valve Replacement||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284141|NCT00209274|Secondary|Number of Participants With Non-cerebral Thromboembolism.|Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.|30 days|ITT population.|||Participants|||Count of Participants
1284142|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284143|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284144|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284145|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284146|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284147|NCT00209274|Secondary|Number of Participants With MR Severity|"MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.~“Discharge” refers to each individual patient’s date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284148|NCT00209274|Secondary|Number of Participants With Non-cerebral Thromboembolism.|Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.|12 months|ITT population.|||Participants|||Count of Participants
1284149|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device|12 months to 5 years|The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
1284150|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device|12 months to 4 years|The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
1284151|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device|12 months to 3 years|The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
1284152|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.|12 months|The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
1284153|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284154|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284155|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284156|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284157|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284158|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284159|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284160|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284161|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284162|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284163|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284164|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284165|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284166|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.~Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|24 months-3 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284167|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.~Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|18-24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284168|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.~Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|12-18 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284169|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.~Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284170|NCT00209274|Secondary|Number of Participants With New Coumadin (Warfarin) Usage||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284171|NCT00209274|Secondary|Number of Participants With New Coumadin (Warfarin) Usage||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284172|NCT00209274|Secondary|Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284173|NCT00209274|Secondary|Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284174|NCT00209274|Secondary|Number of Participants With Hospital Re-admissions|Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284175|NCT00209274|Secondary|Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||hours||Standard Deviation|Mean
1284176|NCT00209274|Secondary|Post-procedure Length of Hospital Stay||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||days||Standard Deviation|Mean
1284177|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
1284178|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|4 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
1284179|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|3 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
1284180|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
1284181|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
1284182|NCT00209274|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|At Discharge (≤ 14 days following index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
1284183|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1284184|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1284185|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1284186|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284187|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284188|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284189|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284190|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284191|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284192|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|At Discharge (≤14 days of index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284193|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1284194|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1284195|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1284196|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284197|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284198|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284199|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284200|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284201|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284202|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|At Discharge (≤14 days of index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1284203|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A “confirmed” case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A “conservative” case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284204|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A “confirmed” case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A “conservative” case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1288795|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg|24-hour fed Leptin dose 0.3 mg/kg|1 DAY||||NG/ML||Standard Deviation|Mean
1284205|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A “confirmed” case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A “conservative” case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284206|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284207|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|12 months|ITT population.|||Participants|||Count of Participants
1284208|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|30 days|ITT population.|||Participants|||Count of Participants
1284209|NCT00209274|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD)|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|12 months|ITT population.|||Participants|||Count of Participants
1284210|NCT00209274|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD).|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|30 days|ITT population.|||Participants|||Count of Participants
1284211|NCT00209274|Secondary|Number of Participants With Hemolysis|"Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:~Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.~Minor: Does not require intervention."|12 months|ITT population.|||Participants|||Count of Participants
1284212|NCT00209274|Secondary|Number of Participants With Hemolysis|"Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:~Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.~Minor: Does not require intervention."|30 days|ITT population.|||Participants|||Count of Participants
1284213|NCT00209274|Secondary|Number of Participants With Thrombosis.|Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.|12 months|ITT population.|||Participants|||Count of Participants
1284214|NCT00209274|Secondary|Number of Participants With Thrombosis.|Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.|30 days|ITT population.|||Participants|||Count of Participants
1284215|NCT00209274|Secondary|Number of Participants With Endocarditis.|Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.|12 months|ITT population.|||Participants|||Count of Participants
1284216|NCT00209274|Secondary|Number of Participants With Endocarditis.|Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.|30 days|ITT population.|||Participants|||Count of Participants
1284217|NCT00209274|Secondary|Number of Participants With Dysrhythmia||12 months|ITT population.|||Participants|||Count of Participants
1284218|NCT00209274|Secondary|Number of Participants With Dysrhythmia||30 days|ITT population.|||Participants|||Count of Participants
1284219|NCT00209274|Secondary|Number of Participants With MAE in Patients Over 75 Years of Age.||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284220|NCT00209274|Secondary|Number of Participants With MAE in Patients Over 75 Years of Age.||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284221|NCT00209274|Secondary|Number of Participants With Major Adverse Events (MAE)||12 months.|Intent to treat (ITT) population.|||Participants|||Count of Participants
1284222|NCT00209274|Secondary|Number of Participants With Major Bleeding Complications.|Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.|12 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284223|NCT00209274|Secondary|Number of Participants With Major Bleeding Complications.|Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1288796|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg|24-hour fed Leptin dose 0.3 mg/kg|1 DAY||||HR||Standard Deviation|Mean
1284224|NCT00209274|Secondary|Number of Participants With Major Vascular Complications|"Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arteriovenous (AV) fistula;~Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;~Vascular Surgical Repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|12 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284225|NCT00209274|Secondary|Number of Participants With Major Vascular Complications|"Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arteriovenous (AV) fistula;~Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;~Vascular Surgical Repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284226|NCT00209274|Secondary|Number of Participants With MAE: Surgery After Device and First Time Surgery Control||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284227|NCT00209274|Secondary|Number of Participants With Procedural Freedom From In-hospital MAE||Day 30|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284228|NCT00209274|Secondary|Number of Participants With Procedural Freedom From In-hospital MAE.||Day 0|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284229|NCT00209274|Secondary|Number of Participants With Mitral Valve Repair Success.|Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284230|NCT00209274|Secondary|Number of Participants With Mitral Valve Repair Success.|Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284231|NCT00209274|Secondary|Number of Participants With Successful Clip Implant and Acute Procedural Success|Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.|30 days|The number of participants analyzed in Device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
1284232|NCT00209274|Secondary|Number of Participants With Acute Surgical Success|Defined as successful mitral valve repair or replacement surgery.|30 Days|The number of participants analyzed in control group includes subjects who had available follow up data at that time frame. Not applicable for Device group patients as device was not implanted. The population includes all patients who underwent the index surgical procedure and excludes 15 patients who were randomized, but not treated.|||Participants|||Count of Participants
1284233|NCT00209274|Secondary|Number of Participants With Acute Procedural Success|Defined as successful MitraClip implantation with resulting MR of 2+ or less.|30 Days|ITT population. The number of participants analyzed in Device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
1284234|NCT00209274|Secondary|Number of Participants With Clip Implant Rate|Defined as the rate of successful implantation of MitraClip(s).|Day 0|The number of participants analyzed includes subjects who had available follow up data at that time frame. MitraClip was not implanted in control group, hence overall number of patients analyzed will remain 0.|||Participants|||Count of Participants
1284235|NCT00209274|Secondary|Regurgitant Fraction|Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of LV stroke volume||Standard Deviation|Mean
1284236|NCT00209274|Secondary|Regurgitant Fraction|Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of LV stroke volume||Standard Deviation|Mean
1284237|NCT00209274|Secondary|Regurgitant Fraction (RF)|RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of LV stroke volume||Standard Deviation|Mean
1284238|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1284239|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1284240|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1284241|NCT00209274|Secondary|Cardiac Index|Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
1284242|NCT00209274|Secondary|Cardiac Index (CI)|Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
1284243|NCT00209274|Secondary|Cardiac Index|Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
1284244|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
1284245|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
1284246|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
1284247|NCT00209274|Secondary|Short Form (SF)-36 Quality of Life Questionnaire.|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0–100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||scores on a scale||Standard Deviation|Mean
1284248|NCT00209274|Secondary|Short Form (SF)-36 Quality of Life Questionnaire.|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0–100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|30 days|"The SF-36 questionnaire consists of 36 questions in relation to eight health concepts:~Physical functioning, role limitations due to physical health, bodily pain,general health perceptions,vitality (energy/fatigue),social functioning,role limitations due to emotional health and general mental health (psychological distress/wellbeing)."|||scores on a scale||Standard Deviation|Mean
1284249|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284250|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284251|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1285673|NCT00187200|Secondary|6 Minute Hall Walk Distance Test (6-MHWD)|Patients were considered non-responders if the 6-MHWD had not improved by greater than or equal to 10% compared to baseline. This statement is accurate and appropriate.|6 months||||participants|||Number
1284252|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284253|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284254|NCT00209274|Secondary|New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284255|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284256|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284257|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284258|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1288797|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg|72-hour fasting Day 3 Leptin dose 0.3 mg/kg|3 DAY||||NG*H/ML||Standard Deviation|Mean
1284259|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284260|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284261|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Baseline|ITT population.|||Participants|||Count of Participants
1284262|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284263|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284264|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284265|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284266|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284267|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284268|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284269|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284270|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284271|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284272|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284273|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1284274|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1284275|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1284276|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1284277|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1284278|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1284279|NCT00209274|Secondary|Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)|Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1284280|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
1284281|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
1284282|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
1284283|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
1284284|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
1284285|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.|At discharge (≤ 14 days following index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
1284286|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1284287|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).||24 months|Per-protocol population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284288|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.||12 months|Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284289|NCT00209274|Secondary|Freedom From All-Cause Mortality||5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284290|NCT00209274|Secondary|Freedom From All-Cause Mortality||4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284291|NCT00209274|Secondary|Freedom From All-Cause Mortality||3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284292|NCT00209274|Secondary|Freedom From All-Cause Mortality||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284293|NCT00209274|Secondary|Freedom From All-Cause Mortality||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
1284294|NCT00209274|Primary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).||12 months|Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284295|NCT00209274|Primary|Number of Participants With Major Adverse Events (MAE)|Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1284558|NCT00204373|Primary|Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.|number of participants with control of gastric acid production|up to 240 months from study enrollment||||participants|||Number
1284296|NCT00209170|Primary|Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24|"The 21-item HDRS measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60, where higher scores indicate greater severity. The HDRS at week 24 was compared to the baseline HDRS and each participant's response was calculated using the below table:~No Response = < 25% change in Depression Rating Scale Score Partial Responder =< 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score"|Baseline, week 24|Last Observation Carried Forward|||participants|||Number
1284297|NCT00209131|Secondary|Medical Evaluation|Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.|2 weeks and 3 months|||||||
1284298|NCT00209131|Primary|Time to Passage of Stone Fragments|Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.|2 weeks and 3 months|No analysis was conducted.||||||
1284299|NCT00209092|Secondary|Long Term Follow up Data on Recurrence and Survival|Number of Patients remained alive and relapse free|2 years||||participants|||Number
1284300|NCT00209092|Primary|Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.|"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.~Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)~Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.~Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site."|1 year||||participants|||Number
1284301|NCT00209027|Primary|BOLD Activation During fMRI Scanning During Performance of a Monetary Reward Task|fMRI BOLD activation during a reward task will be compared between schizophrenia subjects and controls at Baseline. Schizophrenia subjects will switch their baseline medication to aripiprazole and their BOLD activation during the reward task at Baseline will be compared to the endpoint scan.|Baseline and 12 weeks|Prespecified data not collected because the study was terminated before subjects received aripiprazole.||||||
1284302|NCT00208975|Primary|Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab.|"Complete Response (CR): Disappearance of all clinical evidence of active tumor for a minimum of eight weeks and absence of any symptoms related to the tumor.~Partial Response (PR):50% decrease in the sum of the product diameters of all lesions that persist for at least four weeks. No lesion can increase in size and no new lesion can appear during this period.~Stable disease (SD):A tumor that is neither growing nor shrinking.No new tumors have developed"|6 months||||participants|||Number
1284303|NCT00208949|Secondary|Median Survival of Recipients of Grafts Mobilized With GM+G+CSF (Granulocyte Colony-Stimulating Factor (G-CSF)+ Granulocyte Macrophage (GM)-CSF) and G-CSF (Granulocyte Colony-Stimulating Factor )at the Time of Last Follow up.|Median overall survival|5 years||||months||Full Range|Median
1284304|NCT00208949|Primary|Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft||at transplant (1 day)|Sample size determinations for this randomized trial were based on a baseline frequency of mDCs(myeloid dendritic cells) and pDCs( plasmacytoid dendritic cells)within the peripheral blood of 0.5% with a SD equal to the mean (0.5%).|||x10 ^ 6 cells/kg||Standard Error|Median
1284305|NCT00208767|Primary|Change in the Mean Vessel Wall Area (VMA) of the Carotid Bulb From Baseline to 2 Years|The PI will measure carotid artery thickening with magnetic resonance imaging.|Baseline, 2 years||||mm2||Standard Deviation|Mean
1284306|NCT00208507|Secondary|Complication Rates||On-going to end of study|||||||
1284307|NCT00208507|Primary|Harris Hip Total Score|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.|6 weeks, 6, 12 months and last follow up at 24 months or greater||||Units on a scale||Standard Deviation|Mean
1284308|NCT00208494|Primary|Composite Success/Failure|The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.|At 24 months|Out of the 390 subjects, 84 subjects were removed from the analysis for the following reasons: 2 deaths (1 in each arm); 3 protocol violations (2 COM, 1 MOM); 28 bilateral (12 COM, 16 MOM); 39 subjects had no 24-month Harris Hip score (22 COM, 17 MOM); and 12 subjects had no 24-month x-ray (4 COM, 8 MOM).|||Participants|||Number
1284309|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 62 subjects in the PFC Sigma Fixed Bearing and 60 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284587|NCT00203476|Secondary|Change in HDL From Baseline to 12 Weeks.||baseline and 12 weeks|Change in HDL|||mg/dl||Standard Deviation|Mean
1284588|NCT00203476|Secondary|Incidents of Rhabdomyolysis||12 weeks||||participants|||Number
1284589|NCT00203476|Secondary|LFT Elevation||12 weeks||||participants|||Number
1284310|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 60 subjects in the PFC Sigma Fixed Bearing and 62 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284311|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 77 subjects in the PFC Sigma Fixed Bearing and 70 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284312|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 75 subjects in the PFC Sigma Fixed Bearing and 71 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284313|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284314|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284315|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284316|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284317|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284318|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284590|NCT00203476|Primary|LDL Goal Attainment|Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.|12 weeks|intention to treat|||participants|||Number
1284319|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284320|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284321|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants||95% Confidence Interval|Number
1284322|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants||95% Confidence Interval|Number
1284323|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants||95% Confidence Interval|Number
1284324|NCT00208325|Secondary|To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.|Operative|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284325|NCT00208325|Secondary|To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.|Operative|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284326|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284327|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284591|NCT00203424|Secondary|Overall Survival||Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment||||participants|||Number
1284328|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284329|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 122 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284330|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 153 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284331|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 141 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284332|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284333|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284334|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284362|NCT00208091|Primary|Note Errors (Related to Errors in Duration)|Note errors (related to errors in duration in msec) were obtained as measures of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note output from four musical sequences of 8 to 16 notes played. It was calculated by averaging the sequences for each hand, and deriving the square root of the mean of the square of the differences (root mean square error, in msec) in MIDI.|Baseline and 6 weeks post-injection||||msec||Standard Error|Median
1284363|NCT00208026|Secondary|Liver Function Tests||Each visit|||||||
1284335|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284336|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284337|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284338|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284339|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284340|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284341|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284342|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284364|NCT00208026|Secondary|Blood Urea Nitrogen and Creatinine||Each visit|||||||
1284365|NCT00208026|Secondary|Blood Electrolytes and Fasting Glucose||Each visit|||||||
1284343|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
1284344|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 124 subjects in the PFC Sigma Fixed Bearing and 125 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284345|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 146 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284346|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 155 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284347|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 120 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284348|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284349|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284350|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 114 subjects in the PFC Sigma Fixed Bearing and 111 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284351|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 134 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284366|NCT00208026|Secondary|Complete Blood Count With Differential||Each visit|||||||
1284367|NCT00208026|Primary|Transepidermal Water Loss||Each visit|||||||
1284368|NCT00208026|Primary|Pruritus Severity Assessment||Each visit|||||||
1284369|NCT00208026|Primary|Investigator's Global Evaluation of Disease (IGED)||Each visit|||||||
1284352|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 145 subjects in the PFC Sigma Fixed Bearing and 138 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1284353|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 123 subjects in the PFC Sigma Fixed Bearing and 124 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
1284354|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
1284355|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 156 subjects in the PFC Sigma Fixed Bearing and 148 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
1284356|NCT00208325|Primary|To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 153 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
1284357|NCT00208325|Primary|To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 164 subjects in the PFC Sigma Fixed Bearing and 164 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
1284358|NCT00208325|Primary|To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 155 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
1284359|NCT00208325|Primary|To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 168 subjects in the PFC Sigma Fixed Bearing and 167 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
1284360|NCT00208091|Secondary|Subjective Assessment Ratings of Change|Each subject assessed his or her music playing performance change subjectively from -100 percent (fully worse) to 100 percent (fully better).|Baseline to 6 weeks after injection||||percentage change||Standard Deviation|Mean
1284361|NCT00208091|Primary|Note Errors (Related to Errors in Loudness)|Note errors (related to errors in loudness) were obtained as a measure of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note loudness data (decibels) from four musical sequences of 8 to 16 notes. It was calculated by averaging sequences for each hand and taking the square root of the mean of the square of the differences (root mean square error, in decibels) in MIDI notes.|Baseline and 6 weeks post-injection||||decibels||Standard Error|Median
1284370|NCT00208026|Primary|Netherton Area and Severity Assessment (NASA)||Each visit|||||||
1284371|NCT00208026|Primary|Eczema Area and Severity Index (EASI)||Each visit|||||||
1284372|NCT00208026|Primary|Highest Peak Blood Concentration of Pimecrolimus Over All Study Visits|At each scheduled visit, blood concentration of pimecrolimus were obtained. This value reflects the amount of pimecrolimus in the blood. This is measured directly from the blood and provides an estimate of the degree of absorption of the treatment medication through the skin into the blood. Analysis was performed as intent-to-treat with last value carried forward, but no data points were missing.|Each visit up to 18 months|Only the highest peak level documented for the group is reported|||ng/mL|||Number
1284373|NCT00207883|Secondary|Time to Successful Central Line Placement|Time, in seconds, till successful guide wire placement was achieved.|immediate|Critically ill children requiring central venous access.|||seconds||Inter-Quartile Range|Median
1284374|NCT00207883|Primary|Central Line Placement Success|Success was defined as central venous catheter being able to thread into the vessel over the guide wire.|immediate|Population consisted of critically ill children requiring placement of a central venous catheter.|||participants|||Number
1284375|NCT00207740|Secondary|Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects|The endpoint is the change from baseline in domiciliary morning PEFR at Week 24. PEFR— Peak Expiratory Flow Rate (PEFR): A measure of the speed of exhalation. The data were collected in the eDiary which was issued to each participant at screening. PEFR was collected morning and evening each day of the study.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward (LOCF).|||L/min||Standard Deviation|Mean
1284376|NCT00207740|Secondary|Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline|The endpoint is the change from baseline at Week (Wk) 52 in oral corticosteroids (OCS) dose for the randomized patients who received OCS at baseline.|Baseline and Week 52|Analysis of this endpoint includes only pts who received OCS at baseline.Wk 52 OCS dose is the daily OCS dose in the last period, defined as between 2 consecutive visits, in which no change in total daily dose of OCS occurred, prior to Wk 52 visit.Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various timepoints.|||mg/day P. Eq.||Inter-Quartile Range|Median
1284377|NCT00207740|Secondary|Number of Severe Asthma Exacerbations Per Patient From Week 24 Through Week 52; Randomized Patients Who Did Not Discontinue Study Participation Prior to Week 24|The endpoint is the average number of severe asthma exacerbations per patient from Week (Wk) 24 through Wk 52 for the patients who did not discontinue study participation prior to Wk 24|Week 24 to Week 52|Analysis of this endpoint only includes patients (pts) who did not discontinue study participation prior to Wk 24. For the dropouts during the period between Wks 24- 52, worst case in similar pts was used as the number of severe exacerbations. Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various study timepoints|||Events per patient from Wk 24 thru Wk 52||Standard Deviation|Mean
1284378|NCT00207740|Secondary|Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients|The endpoint is change from baseline in rescue medication use at Wk 24 where the rescue medication use was based on the average over 7 days prior to visit.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.|||Puffs/day||Inter-Quartile Range|Median
1284379|NCT00207740|Primary|Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months|The endpoint is the average number of severe asthma exacerbations per patient from baseline through 6 months.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. For the dropouts, the worst case in similar patients was used as the number of severe exacerbations.|||Events per patient through week (Wk) 24||Standard Deviation|Mean
1284380|NCT00207740|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients|The endpoint is the change from baseline in the overall Asthma Quality of Life Questionnaire (AQLQ) score at 6 months. The AQLQ is a validated and self-administered questionnaire to evaluate symptoms and Quality of Life (QOL) in subjects with asthma and it has 32 questions in 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to score the importance of each of the positively identified problems on a 7-point scale (7 = not impaired at all - 1 = severely impaired).|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.|||Points on scale||Inter-Quartile Range|Median
1284381|NCT00207740|Primary|Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second|The endpoint is change from baseline in prebronchodilator clinic-measured percent predicted Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) with Last Observation Carried Forward (LOCF) at 6 months. The baseline visit starts at the end of 2 weeks run in phase.|Baseline and Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using Last Observation Carried Forward (LOCF).|||Percent predicted||95% Confidence Interval|Least Squares Mean
1284382|NCT00207727|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS)|The EDSS is based on an independent neurologist’s examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10.|Baseline, Week 23|Intent to treat. Missing data was imputed. Missing EDSS scores was replaced with the last non-missing EDSS value observed (last observation carried forward).|||Units on a scale||Inter-Quartile Range|Median
1284383|NCT00207727|Secondary|Relapses of Multiple Sclerosis (MS) Through Week 23|Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS.|Week 23|Missing data remained missing. No treatment failure rule was implemented.|||Relapses||Inter-Quartile Range|Median
1284384|NCT00207727|Primary|The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.|A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.|Week 23|Intent to treat. Missing data was imputed. The average number of newly Gd enhancing T1-weighted lesions from all valid visits for the patient will be used when prohibited medications are initiated.|||Lesions||Inter-Quartile Range|Median
1284385|NCT00207714|Secondary|Summary of ACR-N, Index of Improvement at Week 16|The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient’s assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient’s global assessment of disease activity (VAS 0-10); c. Physician’s global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.|Week 16|Intent-to-treat (ITT) and missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. The joint evaluability rules were also applied.|||Scores on scale||Inter-Quartile Range|Median
1284386|NCT00207714|Primary|Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16|ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 16|Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.|||Participants|||Number
1284387|NCT00207142|Secondary|Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase|Percent change in fasting lipids from end of Induction Phase to Week 48 of Maintenance Phase.Percent changes were calculated on the log scale and then back transformed to the original scale.Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening for HDL cholesterol and improvement for all other lipds.|Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.|Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase). Analysis used last observation carried forward (LOCF) to replace missing values.|||percent change||95% Confidence Interval|Mean
1284388|NCT00207142|Secondary|Summary of Adverse Events During Rescue Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.|Participants who received at least 1 dose of Rescue Phase study therapy|||Participants|||Number
1284389|NCT00207142|Secondary|Summary of Adverse Events During Maintenance Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.|Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase).|||Participants|||Number
1284390|NCT00207142|Secondary|Summary of Adverse Events During Induction Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).|Participants who received at least 1 dose of Induction Phase study therapy.|||Participants|||Number
1284391|NCT00207142|Secondary|Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase|Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements <400 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.|Week 16-18, Week 24-26, Week 30-32||||Participants|||Number
1284392|NCT00207142|Secondary|Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase|Description: Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements < 50 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.|Week 16-18, Week 24-26, Week 38-40, Week 64-66||||Participants|||Number
1284393|NCT00207142|Secondary|Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase|Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 400 c/mL to define suppression and virologic rebound.|Baseline, Week 48 of Rescue Phase||||Participants|||Number
1284394|NCT00207142|Secondary|Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase|Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 50 c/mL to define suppression and virologic rebound.|Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.||||Participants|||Number
1284395|NCT00207142|Secondary|Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase|Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies improvement.|\Baseline, Week 48 of Rescue Phase|Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 48 of Rescue Phase)|||log10 c/mL||Standard Error|Mean
1284396|NCT00207142|Secondary|Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase|Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies improvement.|Baseline, Week 24 of Induction Phase|Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 24 of Induction Phase).|||log10 c/mL||Standard Error|Mean
1284397|NCT00207142|Secondary|Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase|Change From Baseline in CD4 Count at Week 48 of Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening.|Baseline, Week 48 of Rescue Phase|Analyses use observed values (participants included are those with CD4 measurements at Baseline and Week 48 of Rescue Phase).|||cells/mm3||Standard Error|Mean
1284398|NCT00207142|Secondary|Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase|Change From Baseline in CD4 Count at Week 24 of Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening.|Baseline, Week 24 of Induction Phase|Analyses use observed values (participants included are those with CD4 measurements at Baseline and at the end of Induction Phase).|||cells/mm3||Standard Error|Mean
1284399|NCT00207142|Secondary|Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase|Change in CD4 Cell Count From End of Induction Phase at Week 48 of Maintenance Phase. Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening.|End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization). Analysis uses observed values (participants included are those with CD4 measurements at end of Induction Phase and at Week 48 of Maintenance Phase).|||cells/mm3||Standard Error|Mean
1284400|NCT00207142|Secondary|Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase|Treatment failure based on HIV-1 RNA ≥ 400 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.|Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48|As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)|||Proportion of participants|||Number
1284401|NCT00207142|Secondary|Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase|Treatment failure based on HIV-1 RNA ≥ 50 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.|Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).|||Proportion of participants|||Number
1284402|NCT00207142|Secondary|Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase|Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 400 c/mL, or last HIV-1 RNA ≥ 400 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.|From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase|As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)|||Percentage of participants|||Number
1284403|NCT00207142|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase|Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.|From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).|||Percentage of participants|||Number
1284404|NCT00207090|Secondary|Number of Participants With Identified ECG Abnormalities|Triplicate 12-lead serial ECGs were performed pre-dose (just prior to infusion), 1.5, 3 (just prior to end of the infusion even if infusion lasted for less than or more than planned 3 hrs), 4, 6, 8 and 24 hrs after start of ixabepilone infusion. Triplicate 12-lead serial ECGs were also to be performed on the date prior to dosing at times approximating post-dose schedule (pre-dose triplicate set of ECGs also qualified as the 24-hr baseline ECGs). Normal ranges for ECG are as follows: heart rate: 40 - 125 bpm; PR: 0.1 - 0.2 msec; QRS: 0.06 - 0.12 msec; QTC: 0.3 - 0.45 msec; QT: 0.3 - 0.5 msec.|Data collected at screening, Day -1 and Day 1 (at 0, 1.5, 3, 4, 6, 8 and 24 hours) after start of infusion.|All participants treated with ixabepilone.|||Participants|||Number
1284405|NCT00207090|Secondary|QT Interval Corrected for Heart Rate (QTcF)|QT interval corrected for heart rate (QTcF) was assessed using triplicate 12-lead serial electrocardiograms (ECGs) that were performed at selected times after the first dose of ixabepilone without rifampin and at matched times prior to the first dose of ixabepilone. Abnormalities occurring at any time during the study were recorded.|Data collected at 0, 1.5, 3, 4, 6, 8 and 24 hours after start of infusion.|All participants treated with ixabepilone. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||millisecond||90% Confidence Interval|Mean
1284453|NCT00206076|Primary|Number of Biopsy Proven Rejections at 12 Months|assessed by liver biopsy using Banff International Consensus Schema|12 months||||participants|||Number
1284454|NCT00205881|Secondary|HINT Sentences in Noise|20 sentences presented in noise at fixed levels|8 months of bilateral cochlear implant use|||||||
1284406|NCT00207090|Secondary|Number of Participants With Abnormal Physical Examination Findings|"Physical examination included height (screening only),weight,BSA,Eastern Cooperative Oncology Group Performance Status (ECOG PS),tendon reflexes,sensory function,motor strength. ECOG PS used to assess disease severity:score of 0 is fully active;1 is restricted physically strenuous activity;2 is ambulatory but unable to work;3 is capable of only limited self care;4 is completely disabled;5 is dead. Normal ranges:height:137-200cm or 54-79 inches;weight:40-135kg or 88-298 pounds (lbs);ECOG Scale:0-4. Abnormalities displayed here are those considered clinically significant by the investigator."|From screening to the off treatment visit.|All treated participants.|||participants|||Number
1284407|NCT00207090|Primary|Urine 6B-Hydroxycortisol to Cortisol Ratio on Day 22|The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.|Day 22 (0-8 hours and 8-24 hours) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Ratio||Standard Deviation|Median
1284408|NCT00207090|Secondary|Number of Participants With Clinically Meaningful Vital Signs Measures|"Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. Normal ranges for the above are as follows: heart rate: 40 - 125 beats per minute (bpm); systolic BP: 65 - 200 millimeters of mercury (mmHg); diastolic BP: 40 - 120 mmHg; respiratory rate: 10 - 25 breaths per minute; temperature: 95 - 105F or 35 - 40.5C. The abnormalities displayed here are those considered clinically significant by the investigator and include abnormalities recorded at any time during study."|From screening to the off treatment visit.|All treated participants.|||participants|||Number
1284409|NCT00207090|Primary|Urine 6B-Hydroxycortisol to Cortisol Ratio on Day -1|The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.|Day -1 (0-8 hours and 8-24 hours), 24 hours before starting of ixabepilone administration.|All treated participants who were evaluable for PK analysis.|||Ratio||Standard Deviation|Mean
1284410|NCT00207090|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T])|AUC (0-T) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||nanogram (ng)*hr/mL||Standard Deviation|Mean
1284411|NCT00207090|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Calcium, Magnesium, Potassium, Sodium, Glucose and Uric Acid.|Abnormalities occurring at any time during the study were graded per NCI CTC (1=mild, 2=moderate, 3=severe, 4=life threatening). Grade 3 and 4 criteria were as follows:Calcium: Grade 3: 6-<7 or >12.5-13.5mg/dL, Grade 4:<6 or >13.5mg/dL. Magnesium: Grade 3:0.6-<0.8 or >2.46-6.6mEq/L, Grade 4:<0.6 or >6.6mEq/L. Potassium: Grade 3:2.5-<3 or >6-7mmol/L, Grade 4:<2.5 or >7.0 mmol/L. Sodium: Grade 3:120-<130 or >155-160 mEq/L, Grade 4:<120 or >160mEq/L. Glucose: Grade 3:30-<40 or >250-500mg/dL, Grade 4:<30 or >500mg/dL. Uric acid: Grade 3:>ULN-10mg/dL with physiologic consequences, Grade 4:>10mg/dL.|Screening, Days 2 and 22.|All treated participants.|||Participants|||Number
1284412|NCT00207090|Primary|Time to Reach Maximum Observed Concentration (T Max)|T max was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Hrs||Full Range|Median
1284413|NCT00207090|Primary|Volume of Distribution at Steady-state (Vss)|Vss was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||L||Standard Deviation|Mean
1284414|NCT00207090|Primary|Total Body Clearance (CLT)|CLT was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Litres(L)/hr||Standard Deviation|Mean
1284415|NCT00207090|Primary|Mean Residence Time Adjusted for Infusion Time (MRT [INF])|(MRT [INF]) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Hrs||Standard Deviation|Mean
1284416|NCT00207090|Primary|Time Taken for Plasma Concentration to Reduce by 50 Percent or Apparent Terminal Plasma Elimination Half-life (T Half)|T half was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Hrs||Standard Deviation|Mean
1284417|NCT00207090|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Bilirubin, Albumin and Phosphorous|Abnormalities occurring at any time during the study were graded per the NCI CTC (1=mild, 2=moderate, 3=severe, 4=life threatening). Grade 3 and 4 criteria were as follows: Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN. Bilirubin: Grade 3: >3-10 x ULN, Grade 4: >10 x ULN. Albumin: Grade 3: <2g/dL (Grade 4 not defined in NCI CTC). Creatinine: Grade 3: >3-6 x ULN, Grade 4: >6 x ULN. Phosphorous: Grade 3: 1-<2mg/dL, Grade 4: <1mg/dL.|Screening, Days 1 and 22.|All treated participants.|||participants|||Number
1284592|NCT00203424|Primary|Time to Tumor Recurrence||Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment||||days||Full Range|Mean
1284418|NCT00207090|Secondary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities occurring at any time during the study were graded per NCI CTC, v3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are given below. Neutrophils: Grade 3: 0.5 - <1.0x10^9/L, Grade 4: <0.5x10^9/L. Leukocytes: Grade 3: 1.0 - <2.0x10^9/L, Grade 4: <1.0x10^9/L. Neutrophils + bands (absolute): Grade 3: 0.5 - <1.0x10^9/L, Grade 4: <0.5x10^9/L. Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Lymphocytes: Grade 3: 0.2 - <0.5x10^9/L, Grade 4: <0.2x10^9/L. Platelets: Grade 3: 25.0 - <50.0x10^9/L, Grade 4: <25.0x10.|Screening, Day 1, Day 8, Day 15, Day 22 and Day 29-36.|All treated participants.|||participants|||Number
1284419|NCT00207090|Secondary|Number of Participants Who Died and Who Experienced Other Serious AEs (SAEs), Grade 3-4 AEs, Drug-related AEs and AEs Leading to Study Drug Discontinuation|AEs:new untoward medical occurrences/worsening of pre-existing medical condition,whether or not related to study drug.SAE:AE resulting in death;life threatening;resulted in persistent/significant disability/incapacity;resulted in/prolonged existing hospitalization;a congenital anomaly/birth defect;overdose.Drug-related AEs: relationship to drug of certain;probable;possible;or missing.Participants who discontinued study due to AE were also recorded.AEs graded using National Cancer Institute (NCI) Common Toxicity Criteria (CTC),v3:Grade 1=mild,2=moderate, 3=severe,4=life threatening,5=death.|From Day 1 to 30 days after the last dose of study drug.|All treated participants.|||participants|||Number
1284420|NCT00207090|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [INF])|AUC (INF) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||nanogram (ng)*hour(hr)/mL||90% Confidence Interval|Geometric Mean
1284421|NCT00207090|Primary|Maximum Plasma Concentration (Cmax)|Cmax was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|Of the 15 patients in each group, only those with evaluable pharmacokinetic (PK) results are presented.|||nanogram (ng)/millilter(mL)||90% Confidence Interval|Geometric Mean
1284422|NCT00206726|Secondary|Number of Participants With Minimal Residual Disease (MRD)|Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.|When CR is confirmed|All participants for whom CR was confirmed|||participants|||Number
1284423|NCT00206726|Secondary|Percentage of Participants With Overall Response at Different Observation Times|Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.|from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier|Subjects who achieved Overall Response (OR) defined as number of subjects who achieved CR + number of subjects who achieved PR|||percentage of participants in response|||Number
1284424|NCT00206726|Secondary|Progression-free Survival (PFS)|Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year|1 year after start of treatment|ITT population (all subjects enrolled and registered). As three subjects never received study medication, they were to be censored at day 1 for all time-to-event analyses. Thus, the Kaplan-Meier estimates beyond day one are the same for both, the ITT and the safety population.|||percentage alive without progression|||Number
1284425|NCT00206726|Secondary|Overall Survival (OS)|Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year|1 year after start of treatment|Safety Population (all subjects treated)|||Percentage of participants alive|||Number
1284426|NCT00206726|Secondary|Overall Response (OR)|Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.|28 days after last cycle with confirmation 2 months later|ITT Population (all subjects enrolled and registered).|||Percentage of participants with CR or PR|||Number
1284427|NCT00206726|Primary|Complete Response (CR)|Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.|28 days after last cycle with confirmation 2 months later|ITT population (all enrolled and registered subjects).|||Percentage of participants with CR|||Number
1284428|NCT00206518|Secondary|Overall Survival||10 years||||participants|||Number
1284429|NCT00206518|Secondary|Disease Relapse|Data associated with relapse and progression will be obtained over the course of 10 years. Relapse/progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|10 years||||participants|||Number
1284455|NCT00205881|Primary|Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.|Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.|8 months of bilateral cochlear implant use|Adults with severe-to-profound hearing loss who received bilateral cochlear implants in the same operation.|||percent of words correct||Standard Deviation|Mean
1284430|NCT00206518|Primary|Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)|"The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as:~Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR)~Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR)~Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively > 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively < 25% therapeutic effect OR Grade 4~No or few modification of tumoral appearance (pNR)."|10 years||||participants|||Number
1284431|NCT00206440|Primary|Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication|Proportion of patients who exhibit no more than one emetic episode and who do not require rescue medication for nausea from 2-7 days following chemotherapy. Thus, we will look at esomeprazole when used to decrease the incidence,severity and duration of nausea/vomiting/retching in breast cancer patients who are receiving anthracycline-based chemotherapy.|2-7 days following chemotheraphy||||Proportion of patients who exhibit no mo|||Number
1284432|NCT00206427|Primary|Clinical Response|Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).|at the end of week 6.|All patients finished 6-week therapy were included. Two patients dropped off therapy early were excluded.|||participants|||Number
1284433|NCT00206427|Secondary|If GW572016 Inhibits HER1 and HER2 Signaling in Situ.||5 years|||||||
1284434|NCT00206336|Primary|Change in TTS|A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint. The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).|baseline to Day 70||||units on a scale||Standard Deviation|Mean
1284435|NCT00206323|Primary|Change From Baseline in Total Tic Score at Day 70|A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint|baseline and Day 70||||units on a scale||Standard Deviation|Mean
1284436|NCT00206102|Secondary|Number of Participants With Potential Extrapyramidal Symptoms (EPS)|Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor|From start of the study treatment to last dose plus 30 days|The Safety analysis set included all randomized participants who received at least 1 dose of study medication|||Participants|||Number
1284437|NCT00206102|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score|AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication|||units on scale||Standard Deviation|Mean
1284438|NCT00206102|Secondary|Change in Barnes Akathisia Rating Scale (BARS) Global Score|BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication|||units of scale||Standard Deviation|Mean
1284439|NCT00206102|Secondary|Change in Simpson-Angus Scale (SAS) Total Score|SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication|||units on scale||Standard Deviation|Mean
1284440|NCT00206102|Secondary|Number of Relapses of Schizophrenia or Schizoaffective Disorder|Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects.|At Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||Relapses|||Number
1284441|NCT00206102|Secondary|Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score|PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
1284456|NCT00205855|Primary|Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.|"The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal tono pain and 10 is equal to worst pain imaginable. This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS."|2 weeks post initial fitting||||participants with > 50% VAS improvement|||Number
1284442|NCT00206102|Secondary|Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score|Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
1284443|NCT00206102|Secondary|Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score|CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization.|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score (not related to CGI-S), and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
1284444|NCT00206102|Secondary|Change in the PANSS Psychopathology Subscale Score|"PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= absent psychosis symptom, 7= extreme symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
1284445|NCT00206102|Secondary|Change in the PANSS Negative Subscale Score|"PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
1284446|NCT00206102|Secondary|Change in the PANSS Positive Subscale Score|"PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
1284447|NCT00206102|Secondary|Change in the Positive and Negative Syndrome Scale (PANSS) Total Score|"PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
1284448|NCT00206102|Primary|Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale|Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.|||Participants with P type event|||Number
1284449|NCT00206102|Primary|Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale|Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.|||Participants with N type event|||Number
1284450|NCT00206102|Primary|Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale|Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.|||Participants with C type event|||Number
1284451|NCT00206076|Secondary|Number of Participants With Adverse Events Including Infections at 12 Months||12 months|everyone enrolled who completed the study|||participants|||Number
1284452|NCT00206076|Secondary|Patient and Graft Survival at 12 Months||12 months|everyone enrolled who completed the study|||participants|||Number
1284457|NCT00205803|Secondary|Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.|One month after the Toddler Dose (13 to 16 months of age)|All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
1284458|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.|One month after the toddler dose (13 to 16 months of age)|All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype.|||Percentage of participants||95% Confidence Interval|Number
1284459|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype.|||Percentage of participants||95% Confidence Interval|Number
1284460|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.|||EU/mL||95% Confidence Interval|Geometric Mean
1284461|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample.|||titer||95% Confidence Interval|Geometric Mean
1284462|NCT00205803|Secondary|Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.|||IU/mL||95% Confidence Interval|Geometric Mean
1284463|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series|GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.|one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.|||milli International Units (mIU)/mL||95% Confidence Interval|Geometric Mean
1284464|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.|||μg/mL||95% Confidence Interval|Geometric Mean
1284465|NCT00205803|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.|One month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component.|||Percentage of participants||95% Confidence Interval|Number
1284496|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TtAr|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||mm^2||Standard Error|Least Squares Mean
1284466|NCT00205803|Secondary|Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)|All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1284467|NCT00205803|Secondary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.|One month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
1284468|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|One month after the toddler dose (at 13 to 16 months of age)|The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1284469|NCT00205803|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|one month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
1284470|NCT00205803|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.|Within 15 days after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values.|||percentage of participants|||Number
1284471|NCT00205803|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category.|Within 15 days after each dose|The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values.|||percentage of participants|||Number
1284472|NCT00205777|Secondary|Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points."|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Deviation|Mean
1284473|NCT00205777|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points."|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Deviation|Mean
1284474|NCT00205777|Secondary|Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||mm||Standard Error|Least Squares Mean
1284475|NCT00205777|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||millimeter (mm)||Standard Deviation|Mean
1284476|NCT00205777|Secondary|Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Error|Least Squares Mean
1284477|NCT00205777|Secondary|European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Deviation|Mean
1284478|NCT00205777|Secondary|Change From Baseline in Women’s Health Questionnaire (WHQ) at Month 12, 24 and 36|WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Error|Least Squares Mean
1284479|NCT00205777|Secondary|Women’s Health Questionnaire (WHQ)|WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Deviation|Mean
1284515|NCT00205777|Secondary|Change From Baseline in Height at Month 60|Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.|||mm||Standard Error|Least Squares Mean
1284480|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFRBV|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||square millimetre/square millimetre/year||Standard Error|Least Squares Mean
1284481|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFRBV|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||square millimetre/square millimetre/year||Standard Error|Least Squares Mean
1284482|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TbN|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||ratio/mm||Standard Error|Least Squares Mean
1284483|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: TbN|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||ratio/millimeter (ratio/mm)||Standard Error|Least Squares Mean
1284484|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: MAR|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||mcm/d||Standard Error|Least Squares Mean
1284485|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: MAR|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||mcm/days (mcm/d)||Standard Error|Least Squares Mean
1284486|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: Mlt|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||days||Standard Error|Least Squares Mean
1284487|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: Mlt|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||days||Standard Error|Least Squares Mean
1284516|NCT00205777|Secondary|Change From Baseline in Height at Month 36|Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.|||millimeter (mm)||Standard Error|Least Squares Mean
1284488|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: ACF|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||Activation of bone formation/year||Standard Error|Least Squares Mean
1284489|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: ACF|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||Activation of bone formation/year||Standard Error|Least Squares Mean
1284490|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFRTS|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||cubic millimetre/square millimetre/year||Standard Error|Least Squares Mean
1284491|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFRTS|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||cubic millimetre/square millimetre/year||Standard Error|Least Squares Mean
1284492|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: SuD|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||square millimeter per cubic millimeter||Standard Error|Least Squares Mean
1284493|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: SuD|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||square millimeter per cubic millimeter||Standard Error|Least Squares Mean
1284494|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFP, RP and RmP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||yrs||Standard Error|Least Squares Mean
1284495|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFP, RP and RmP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||years (yrs)||Standard Error|Least Squares Mean
1288798|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg|72-hour fasting Day 3 Leptin dose 0.3 mg/kg|3 DAY||||NG/ML||Standard Deviation|Mean
1284497|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: TtAr|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||Square millimeter (mm^2)||Standard Error|Least Squares Mean
1284498|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TSG|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||mm||Standard Error|Least Squares Mean
1284499|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||millimeter (mm)||Standard Error|Least Squares Mean
1284500|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||mcm||Standard Error|Least Squares Mean
1284501|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||micrometer (mcm)||Standard Error|Least Squares Mean
1284502|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||Percentage of indices||Standard Error|Least Squares Mean
1284503|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||Percentage of indices||Standard Error|Least Squares Mean
1284593|NCT00203424|Secondary|Time to Tumor Progression.|Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence|Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment||||days|||Number
1284504|NCT00205777|Secondary|Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36|Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).|Baseline, Months 6, 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
1284505|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 72, 84|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Percent change||Inter-Quartile Range|Median
1284506|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 36, 60|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
1284507|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 3, 6, 12|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
1284508|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Months 72 and 84|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 72, 84|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Percent change||Inter-Quartile Range|Median
1284509|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Months 36 and 60|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 36, 60|mITT of SP1 population included all randomized participants who took at least 1 dose of test article.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
1284510|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 3, 6, 12|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
1284511|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Month 72, 84|Modified ITT(mITT) population of SP1 population:randomized participants who took at least 1 dose of test article;had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.|||Percent change||Standard Deviation|Mean
1284512|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Month 48, 60|mITT population of SP1 population:randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.|||Percent change||Standard Error|Least Squares Mean
1284513|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Months 6, 12, 18, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.|||Percent change||Standard Error|Least Squares Mean
1284514|NCT00205777|Secondary|Change From Baseline in Height at Month 84|Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 84|mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||mm||Standard Deviation|Mean
1284517|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 84|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 84|mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.|||Percentage of participants||95% Confidence Interval|Number
1284518|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 60|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.|||Percentage of participants||95% Confidence Interval|Number
1284519|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 36|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.|||Percentage of participants||95% Confidence Interval|Number
1284520|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 84|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 84|mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1284521|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 60|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1284522|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 36|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1284523|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 84|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 84|mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1284524|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 60|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1284525|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 36|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1284537|NCT00205699|Secondary|Change in Insulin-stimulated Glucose Rate of Appearance (Glucose Ra)|This study hypothesized that antipsychotic treatment would decrease hepatic insulin sensitivity, as measured by the rate of appearance of glucose (glucose Ra), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||percentage of % change||Standard Deviation|Mean
1284526|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 84|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 84|SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Breast cancer per 1000-women years|||Number
1284527|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 60|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 60|SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Breast cancer per 1000-women years|||Number
1284528|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 36|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 36|Safety Population 1 (SP1) included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Breast cancer per 1000-women years|||Number
1284529|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 84|New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 84|Modified ITT(mITT) population of safety population category one(SP1) population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.|||Percentage of participants||95% Confidence Interval|Number
1284530|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 60|New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.|||Percentage of participants||95% Confidence Interval|Number
1284531|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 36|New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 36|Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.|||Percentage of participants||95% Confidence Interval|Number
1284532|NCT00205712|Secondary|Visual Analog Scale (VAS) Anxiety Rating|Anxiety was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.|Before Ketamine, During Ketamine, Post Ketamine, 1 week follow up||||Scale of 1-10||Standard Deviation|Mean
1284533|NCT00205712|Secondary|Visual Analog Scale (VAS) Pain Intensity|Pain intensity was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.|Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow up|Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.|||Scale of 1-10||Standard Deviation|Mean
1284534|NCT00205712|Primary|Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score|Participant received behavioral ratings before medication and during medication for the primary analysis comparison. This is an observer-scale with a value range from 0-6 (0=no symptoms 6=worst symptoms)|Before Ketamine, During Ketamine|Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.|||Scale of 0-6||Standard Deviation|Mean
1284535|NCT00205699|Secondary|Change in MRI-measured Subcutaneous Abdominal Fat|This study hypothesized that antipsychotic treatment would increase subcutaneous abdominal fat, as measured by abdominal magnetic resonance imaging (MRI), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||Change in cm-squared||Standard Deviation|Mean
1284536|NCT00205699|Secondary|Change in MRI-measured Visceral Abdominal Fat|This study hypothesized that antipsychotic treatment would increase visceral abdominal fat, as measured by abdominal magnetic resonance imaging (MRI), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||Change in cm-squared||Standard Deviation|Mean
1284538|NCT00205699|Secondary|Change in Insulin-stimulated Glycerol Rate of Appearance (Glycerol Ra)|This study hypothesized that antipsychotic treatment would decrease insulin sensitivity at adipose tissue, as measured by the insulin-stimulated rate of disappearance of glycerol (glycerol Ra), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||percentage of % change||Standard Deviation|Mean
1284539|NCT00205699|Primary|Change in Insulin-stimulated Glucose Rate of Disappearance (Glucose Rd)|This study hypothesized that antipsychotic treatment would decrease insulin sensitivity at muscle, as measured by the insulin-stimulated rate of disappearance of glucose (glucose Rd), with larger adverse effects for olanzapine.|12 weeks|Children ages 6-18 with a Diagnostic and Statistical Manual Text Revision (DSM-IV-TR) diagnosis and clinically significant aggression or irritability|||percentage of % change||Standard Deviation|Mean
1284540|NCT00205699|Primary|Change in DEXA % Body Fat|This study hypothesized that antipsychotic treatment would increase percent total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||percent body fat||Standard Deviation|Mean
1284541|NCT00205504|Secondary|Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|These inflammatory markers are assessed through blood analysis of Soluble Vascular Cell Adhesion Molecule (sVCAM) and soluble intercellular adhesion molecule (sICAM).|Baseline and 6 months||||ng/mL||Standard Deviation|Mean
1284542|NCT00205504|Secondary|Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months||||cm||Standard Deviation|Mean
1284543|NCT00205504|Secondary|Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Body Mass Index is a calculation of height and weight: kg/m²|Baseline and 6 months||||kg/m²||Standard Deviation|Mean
1284544|NCT00205504|Secondary|Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months||||mm Hg||Standard Deviation|Mean
1284545|NCT00205504|Secondary|Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Inflammatory marker is assessed through blood analysis for Monocyte chemotactic protein-1 (MCP-1).|Baseline and 6 months||||pg/mL||Standard Deviation|Mean
1284546|NCT00205504|Secondary|Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Waist-to-hip ratio is assessed through calculated ratio of waist and hip circumference.|Baseline and 6 months||||ratio||Standard Deviation|Mean
1284547|NCT00205504|Secondary|Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months||||pg/mL||Standard Deviation|Mean
1284548|NCT00205504|Secondary|Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Inflammatory markers are assessed through blood analysis for C-reactive protein (hs-CRP) and adiponectin.|Baseline and 6 months||||ng/mL||Standard Deviation|Mean
1284549|NCT00205504|Secondary|Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women|The lipid profile is assessed through blood sample analysis for low-density lipoprotein (LDL), Triglycerides and high-density lipoprotein (HDL).|Baseline and 6 months||||mg/dL||Standard Deviation|Mean
1284550|NCT00205504|Primary|Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women|Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).|Baseline and 6 months||||mIU/L||Standard Deviation|Mean
1284551|NCT00205374|Secondary|12-month Reduction in Voice Handicap Index (VHI) Score|"Voice Handicap Index. This scale rates a patient’s perception of voice related handicap in the domains of functional, physical, and emotional. There are 10 questions for each domain. Each question is rated by the subject on a 5-point scale, never =0, almost never =1, sometimes =2, almost always =3, always =4). A lower total score or domain score indicates improved, or less, voice handicap. Thus, the maximum total score is 4 X 30 = 120. For each domain, the maximum score is 4 X 10 = 40. Scores of 0 are the lowest possible score. In the paper we say that the Maximum score is 100, but obviously is it actually 120. Complete scale = 0-120.~Lower score indicates improved perceived voice-realted quality of life."|2 months and 12 months||||scores on a scale||Full Range|Mean
1284552|NCT00205374|Primary|Change in Papilloma Severity|"Derkay Severity Score. Minimum Score is Zero. Maximum score is 86. Treatment of RRP with cidofovir injection will be considered efficacious if drug group patients experience clinically or statistically significant changes in papilloma severity and inter-surgery time intervals (relative to pre-treatment assessments), when compared with placebo group patients.~The scale rates - Voice (normal 0, abnormal 1, aphonic 2) Stridor (absent 0, present with activity 1, present at rest 2) Urgency of the intervention (scheduled 0, elective 1, urgent 2, emergent 3) Respiratory distress (none 0, mild 1, mod 2, severe 3, extreme 4).~For multiple anatomical sites (18 or more) in the upper airway, left and right sides, lesions are rated as 0=none, 1=surface lesion, 2=raised lesion, and 3=bulky lesion).~A higher rating value indicates more advanced disease and a worse outcome."|2 months and 12 months||||scores on a scale||Full Range|Mean
1284553|NCT00205348|Primary|Swallowing Quality of Life|The swallowing quality of life (SWAL-QOL) validated outcomes assessment tool will be used before and one year after surgery to measure changes in swallowing-related QOL in patients undergoing thyroid surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function. A score of 0 represents the least favorable state, and 100 the most favorable. It has been validated and has favorable psychometric properties, including high internal-consistency reliability and reproducibility. The scales of the instrument differentiate patients with oropharyngeal dysphagia from normal swallowers and are sensitive to clinically-relevant differences in dysphagia severity in patients with medically and surgically treated conditions.|One year|All data will be analyzed using standard statistical tools including student T-test and ANOVA.|||units on a scale||Full Range|Mean
1284554|NCT00205049|Primary|Survival at 28 Days||28 days|Study was terminated before any data was gathered/analyzed.||||||
1284555|NCT00204932|Secondary|Total Fat Oxidation|24 hour respiratory gas analysis|6 months|||||||
1284559|NCT00203996|Primary|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After 3 Nights of SWS Suppression]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|3 nights|Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.|||mU/(liter x min)||Standard Error|Mean
1284560|NCT00203996|Primary|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|Baseline|Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.|||mU/(liter x min)||Standard Error|Mean
1284561|NCT00203996|Secondary|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [After Treatment]|This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.|15 minutes over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||nanogram/milliliter||Standard Error|Mean
1284562|NCT00203996|Secondary|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [Baseline]|This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.|15 minutes over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||nanogram/milliliter||Standard Error|Mean
1284563|NCT00203996|Secondary|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment]|This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.|10 minutes, over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||microgram/deciliter||Standard Error|Mean
1284564|NCT00203996|Primary|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [After CPAP]|Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.|8 weeks|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||mU/(liter x min)||Standard Error|Mean
1284565|NCT00203996|Primary|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [Baseline]|Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.|baseline (0 weeks)|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||mU/(liter x min)||Standard Error|Mean
1284566|NCT00203996|Secondary|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [Baseline]|This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.|10 minutes, over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||microgram/deciliter||Standard Error|Mean
1284567|NCT00203996|Secondary|Aim 1: Visceral Adiposity [After Treatment]|Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.|up to half of an hour|No participants were randomized to this arm.||||||
1284568|NCT00203996|Secondary|Aim 1: Visceral Adiposity [Baseline]|Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.|up to half of an hour|No participants were randomized to this arm.||||||
1284569|NCT00203996|Secondary|Aim 1: Blood Pressure [After Treatment]|Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.|8 weeks|No participants were randomized to these study arms.||||||
1284570|NCT00203996|Secondary|Aim 1: Blood Pressure [Baseline]|Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.|baseline (0 weeks)|No participants were randomized to these study arms.||||||
1284571|NCT00203996|Primary|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After CPAP]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|8 weeks|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||mU/(liter x min)||Standard Error|Mean
1284572|NCT00203996|Primary|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|baseline (0 weeks)|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||mU/(liter x min)||Standard Error|Mean
1284573|NCT00203996|Primary|Aim 1: Apnea-hypopnea Index (AHI) [After Treatment]|Apnea–hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.|8 weeks|No participants were randomized to these study arms.||||||
1284574|NCT00203996|Primary|Aim 1: Apnea–Hypopnea Index (AHI) [Baseline]|Apnea–hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.|baseline|No participants were randomized to these study arms.||||||
1284575|NCT00203931|Secondary|Progression-free Survival Based on Serum Biomarker Status|Progression-free survival in this analysis looking at the association between a serum proteomic biomarker and progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.|up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 10 patients did not have a pre-treatment/baseline serum marker classification and thus were excluded from this analysis.|||months||95% Confidence Interval|Median
1284576|NCT00203931|Secondary|Overall Survival|Overall survival will be defined as the time from the start of treatment until death from any cause.|Up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab)|||months||95% Confidence Interval|Median
1284577|NCT00203931|Secondary|Objective Response Rate|Objective response (complete response [CR] + partial response [PR]) will be evaluated using RECIST criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter of target lesions.|up to 2 years|Includes evaluable patients (those that received at least 3 doses of cetuximab).|||percentage of participants||95% Confidence Interval|Number
1284578|NCT00203931|Secondary|Progression-free Survival Based on Rash Development|Progression-free survival in this landmark analysis looking at the utility of early rash in predicting progression-free survival will be defined as the time from day 22 of study therapy until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first. Patients last known to be alive and progression-free were censored at the date of the last scan without evidence of progression.|up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 2 patients died or progressed prior to day 22 of cetuximab therapy and thus were excluded from this analysis.|||months||Standard Error|Median
1284579|NCT00203931|Primary|Progression-free Survival|Progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.|Up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab)|||months||95% Confidence Interval|Median
1284580|NCT00203892|Secondary|Evidence of Dose Limiting Toxicities of Immunization With Modified CEA (Carcinoembryonic Antigen) Peptide.|Dose-limited toxicity included Grade 2 or higher hemorrhage or allergic reaction or clinical evidence of autoimmune disease. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v2.0.|participants were followed while they were on study treatment, a median of 8 weeks||||participants|||Number
1284581|NCT00203892|Primary|Maximum T Cell Response From Baseline|"T cell frequency (spots per 10^4 CD8+ cells) was measured by ELISPOT (Enzyme-linked immunosorbent spot) assay. Blood was collected for this assay at baseline and every 4 weeks for the first 8 cycles. After the eighth cycle, a blood sample was collected at the time of disease progression. The maximum T cell response was calculated as: peak value on treatment - baseline value.~A positive value indicates an increase from baseline."|baseline and every 4 weeks on treatment|The analysis population for the primary outcome included the 14 patients who received at least 3 doses of the CEA vaccine and had a ELISPOT at least at baseline and after the 3rd cycle.|||spots per 10^4 CD8+ cells||Full Range|Median
1284582|NCT00203502|Secondary|Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer|pCR rate for triple negative patients--percent|at surgery, one day|Patients with triple negative breast cancer|||% pCR among triple negative pts||90% Confidence Interval|Number
1284583|NCT00203502|Secondary|To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline|Absolute change in LVEF, where LVEF values are measured in percentage units|Immediately before treatment and 1 year after start of treatment||||Percentage of LVEF||Standard Deviation|Mean
1284584|NCT00203502|Secondary|Percentage of Participants With Grade 3 or 4 Adverse Events|Percent of participants who had at least one grade 3 or 4 adverse event|After each chemotherapy infusion, approximately one hour||||percentage of pts w/ grade 3/4 AE||90% Confidence Interval|Number
1284585|NCT00203502|Secondary|Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab.|Clinical complete response was defined using RECIST response categories as the clinical response to chemotherapy|At completion of chemotherapy treatment, an average of one hour|All participants evaluated surgically|||percentage of pts w/ cCR||90% Confidence Interval|Number
1284586|NCT00203502|Primary|Percentage of Participants With Pathological Complete Response.|Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.|Participants were assessed during surgery, an average of one hour||||percentage of evaluable patients||90% Confidence Interval|Number
1284594|NCT00203424|Primary|To Evaluate the Efficacy of Bevacizumab Plus Erlotinib||Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.|Of the 23 subjects registered for treatment, 19 were analysed for efficacy, 4 subjects were excluded from analysis because of withdrawal of subjects prior to first tumor assessment.|||participants|||Number
1284595|NCT00203411|Secondary|Quality of Life of Patients|"Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Trial Outcome Index (TOI) – a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. Questions address Physical, Emotional and Functional Well-Being. Scale: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), and very much (4). Higher numbers indicate a better state of well being. Scale 0 -136. Higher numbers indicating a better state of well-being.~The Overall scores for the FACT-C Composite scale range between 0-100 with higher scores indicating a better state of well being.~The EQ VAS= Euro Quality of Life 5 Dimension Self Reported Healthstate. It records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labeled 0 ‘Best imaginable health state’ and 100 ‘Worst imaginable health state’."|Baseline, Cycle 2, and End of Study||||score on a scale||Standard Deviation|Mean
1284596|NCT00203411|Secondary|Response Rates|Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|every 21 days up to 12 months||||participants|||Number
1284597|NCT00203411|Primary|Number of Subjects Requiring Dose Modifications|Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.|3 months|all subjects that received chemotherapy|||participants|||Number
1284598|NCT00203411|Primary|Time to Disease Progression|Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date|12 months||||months||95% Confidence Interval|Median
1284599|NCT00203307|Secondary|Reduction in Days Using an Acute Headache Treatment During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.||84 day period on olanzapine compared to 84 day period on placebo|||||||
1284600|NCT00203307|Secondary|Reduction of Migraine Attack Frequency During Each 28-day Interval of the Active Treatment Period as Compared to Each 28-day Interval of the Placebo Treatment Period, Per Subject. Individual Migraine Attacks Are Separated by 48-hours Pain Free Time. A||each 28 day interval of active treatment c ompared to placebo|||||||
1284601|NCT00203307|Primary|Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.|"Definition of migraine headache period: One migraine period is defined as a 24-hour period starting at the time of onset of the migraine headache, during which the migraine headache is present*.~Definition of time frames: First treatment period: Day 1 to 84. Second treatment period: day 113-196. Washout phase is day 85-112."|84 day period on placebo compared to 84 day period on olanzapine||||headache periods||Standard Deviation|Mean
1284602|NCT00203294|Secondary|To Evaluate Effect of Treatment on Associated Symptoms (Nausea, Phonophobia and Photophobia) as Measured Using a 4 Point Scale (None, Mild, Moderate, Severe) Compared to Historical Baseline, and Between the Two Treatment Groups.||20 minutes|||||||
1284603|NCT00203294|Secondary|To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.||20 minutes|||||||
1284604|NCT00203294|Primary|Decrease in Headache Pain, as Measured on an 11-point Pain Scale (0=no Pain, 10=Excruciating Pain). Change in Headache Pain 20 Minutes After Injection Will be Compared Between Treatment Groups.||20 minutes|||||||
1284605|NCT00203294|Primary|Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain|Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment|20 minutes|There were 15 patients in group A (no steroids injected) and 14 in group B (steroids injected).|||units on a scale||Standard Deviation|Mean
1284606|NCT00203268|Primary|Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.|Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.|2 hours post treatment and 4 hours post treatment||||participants|||Number
1284607|NCT00203242|Secondary|Use of Acute and Rescue Medications During Loading (2 Days) and Maintenance Phases as Compared to Subject-reported Baseline. This Will be Calculated Using the Total Number of Doses of Acute Medications Per 24-hour Period Calendar Days.||Baseline compared to maintenance (up to 47 days)|||||||
1284608|NCT00203242|Secondary|Change in Frequency of Attacks Per 24 Hour Period, Duration of Individual Attacks (in Minutes), or Severity of Attacks Compared to the Subject-reported Baseline Values.||Compare Baseline through 47 days|||||||
1284658|NCT00201864|Secondary|Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant|5 mL of venous whole blood was obtained before dosing and then at 1, 2, 4, 6, 8, and 24 hours after exemestane ingestion on each of the 2 time points.|Day 7 and Day 120|Only 9 patients had evaluable PK data collected and analyzed|||ng/ml||Standard Deviation|Mean
1284609|NCT00203242|Primary|Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline.|Severity: measured on an 11 point scale, where 0 = no pain and 10= excruciating pain. Outcome is time to 50% reduction in severity (or frequency) compared to baseline (prior to treatment).Frequency: Number of attacks per day.The Time to significant response was measured 2 ways: significant initial response and significant maintained response. For initial response, the time to significant response was: Mean of 2.1(1.5) days for severity and 1.9 (1.6) days for frequency. The time to significant response maintained was 29.7 (13.8) for severity and 29.0 (14.3) for frequency.|baseline (day 0) through 47 days after first infusion||||days||Standard Deviation|Mean
1284610|NCT00203229|Primary|Average Number of Pain Attacks|The average number of attacks daily experienced between Visit #1 and Visit #2 (baseline diary) was compared to the average daily number of attacks recorded between Visit #5 and Visit #7 after the patient has titrated the drug to the maximum tolerated dose.|Day 150 Visit #7||||Pain attacks||Standard Deviation|Mean
1284611|NCT00203216|Secondary|Change in Use of Acute Agents Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.||Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.|||||||
1284612|NCT00203216|Secondary|Change in Average Severity if Migraine Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period||Baseline period compared to 28 day interval prior to Visit 4-7.|||||||
1284613|NCT00203216|Secondary|Change in Number of Migraine Days Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period|"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:~visit_4 = first follow-up interval (0 to 28 days after starting study drug)~visit_5 = second follow-up interval (28 to 56 days)~visit_6 = third follow-up interval (56 to 84 days)~visit_7 = fourth follow-up interval (84 to 126 days)"|Baseline period (day -28 to day 0) compared to the 28 day period prior to Visit 4-7.|||||||
1284614|NCT00203216|Primary|The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.|"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:~visit_4 = first follow-up interval (0 to 28 days after starting study drug)~visit_5 = second follow-up interval (28 to 56 days)~visit_6 = third follow-up interval (56 to 84 days)~visit_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI"|Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).||||migraine attacks per month||Standard Deviation|Mean
1284615|NCT00203203|Secondary|Linear Local Shortening (LLS)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.|baseline and 6 months||||percentage of linear local shortening||Standard Deviation|Mean
1284616|NCT00203203|Secondary|Endocardial Unipolar Voltages (UPV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV.|baseline and 6 months|The data was analyzed for all participants in control and treated groups.|||Unipolar voltage (mV)||Standard Deviation|Mean
1284617|NCT00203203|Secondary|Left Ventricular End-Systolic Volume (LVESV) (ml)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||ml||Standard Deviation|Mean
1284618|NCT00203203|Secondary|Left Ventricular End-Diastolic Volume (LVEDV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.|baseline, 3 months and 6 months||||Volume in left ventricle (milliliters)||Standard Deviation|Mean
1284619|NCT00203203|Secondary|Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%)|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the gold standard."|baseline and 6 months|The data was analyzed for all participants in control and treated groups.|||Angiography LVEF (%)||Standard Deviation|Mean
1284620|NCT00203203|Secondary|Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||Left Ventricular Ejection Fraction (%)||Standard Deviation|Mean
1284621|NCT00203203|Secondary|Echocardiography Wall Motion Score Index (WMSI)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.|baseline and 3 months|The data was analyzed for all participants in control and treated groups.|||Wall Motion Score Index||Standard Deviation|Mean
1284677|NCT00201734|Secondary|One Year Survival for Patients|For patients enrolled on the Phase II portion of the trial the One-year survival was measured as the percentage of patients alive 1 year after their treatment in the trial.|Up to 1 year||||percent of patients||95% Confidence Interval|Number
1284622|NCT00203203|Secondary|Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.|baseline and 3 months|The data was analyzed for all participants in control and treated groups.|||VE/VCO2 slope||Standard Deviation|Mean
1284623|NCT00203203|Secondary|Echocardiography (EF)Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||Ejection Fraction %||Standard Deviation|Mean
1284624|NCT00203203|Secondary|Myocardial Oxygen Consumption (MVO2)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||Percentage of Oxygen Saturation||Standard Deviation|Mean
1284625|NCT00203203|Secondary|New York Heart Association (NYHA)Classification|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.~Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||NYHA Functional Class||Standard Deviation|Mean
1284626|NCT00203203|Secondary|Canadian Cardiovascular (CCS) Angina Score|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).~Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||units on a scale||Standard Deviation|Mean
1284627|NCT00203203|Primary|Safety of Autologous-bone-marrow Injections|Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).|up to 2 weeks post-procedure, 3 months and 6 months|Adverse events which occurred in all participants.|||participants|||Number
1284628|NCT00203047|Secondary|Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions|"Results represent the database as of January 29, 2009.~The difference in hypointense brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage."|Day 0, Month 36 or early termination visit|Treated population of participants with an MRI at the stated time frames.|||cm^3||Standard Deviation|Mean
1284629|NCT00203047|Secondary|Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions|"Results represent the database as of January 29, 2009.~The difference in T2 brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden."|Day 0, Month 36 or the early termination visit|Treated population of participants with an MRI at the stated time frames.|||cm^3||Standard Deviation|Mean
1284630|NCT00203047|Secondary|Cumulative Number of Enhancing Lesions at Months 12, 24 and 36|"Results represent the database as of January 29, 2009.~Enhancing lesions are lesions that show inflammation on an MRI and are assumed to be new lesions. The sum of enhancing lesions observed in MRIs taken at months 12, 24 and 36 are offered."|Months 12, 24, and 36|Treated population who had at least a 12 month MRI|||lesions||Standard Deviation|Mean
1284631|NCT00203047|Primary|Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method|"Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change.~Adjusted (least square) mean values are presented."|Day 0, latest scan at month 24, 36 or early termination visit|Treated population of participants who had both a baseline MRI and an MRI at least one of the three during study time frames. The latest MRI was used if more than one during study MRI was available.|||percent change of baseline brain volume||Standard Error|Least Squares Mean
1284641|NCT00202644|Secondary|Change From Baseline in White Blood Cell Count Over Time|White blood cell count was evaluated throughout the study.|Baseline and Month 6, 12, 18, 24, 30 and 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively.|||10^9 cells per liter||Standard Deviation|Mean
1284655|NCT00201877|Primary|Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma.|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.|Day 1 of each cycle|grade 3 neurotoxicity which consisted of constipation/ileus, sensory or motor neuropathy, or orthostatic hypotension|||patients|||Number
1284632|NCT00202878|Secondary|Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, non-fatal MI, documented UA that requires admission into a hospital, all revascularization (including non-coronary) occurring at least 30 days after randomization, and non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, non-fatal MI, unstable angina with hospitalization, all revascularization occurring ≥ 30 days after randomization, and non-fatal stroke within 7 Years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
1284633|NCT00202878|Secondary|Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
1284634|NCT00202878|Secondary|Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: death from any cause, major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, major coronary event, or non-fatal stroke within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
1284635|NCT00202878|Primary|Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death, major coronary Event (non-fatal myocardial infarction [MI], documented unstable angina [UA] requiring hospitalization, or coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) ≥ 30 days after randomization), or non-fatal Stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced cardiovascular death, major coronary event, or non-fatal stroke within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
1284636|NCT00202839|Secondary|The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.|Virologic response was defined as undetectable HCV-RNA level in the blood.|48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)|Intention to treat [ITT] population|||Percentage of Participants|||Number
1284637|NCT00202839|Primary|The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy|24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy|Intention to treat [ITT] population defined as participants who received at least one dose of study medication.|||Percentage of participants|||Number
1284638|NCT00202722|Secondary|Patient Satisfaction|Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied.|From start of remifentanil treatment until delivery||||Participants|||Number
1284639|NCT00202722|Primary|Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)|Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints.|From start with remifentanil treatment until delivery, up to 8 hours.|Per protocol|||millimeters||Standard Deviation|Mean
1284640|NCT00202644|Secondary|Change From Baseline in Red Blood Cell Count Over Time|Red blood cell count was evaluated throughout the study.|Baseline and Month 6, 12, 18, 24, 30 and 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively.|||10^12 cells per liter||Standard Deviation|Mean
1284656|NCT00201877|Primary|Overall Response Rate|To determine the overall survival in patients with relapsed or refractory mantle cell and follicular lymphoma following treatment with rituximab and Velcade™.|Every 3 months||||percentage of patients|||Number
1284642|NCT00202644|Secondary|Number of Participants With Thrombotic and Haemorrhagic Events|Thrombohaemorrhagic events are a well-known complication of the underlying essential thrombocythemia (ET) and disease progression. Events such as arterial and venous thrombosis, serious haemorrhage (including gastrointestinal haemorrhage), and death from vascular causes have been reported in participants who received cytoreductive treatment.|From the signing of informed consent until the last study-related visit (Month 36)|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||participants|||Number
1284643|NCT00202644|Secondary|Time to Partial Response|Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).|Baseline up to Month 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||days||95% Confidence Interval|Median
1284644|NCT00202644|Secondary|Time to Complete Response|Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).|Baseline up to Month 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||days||95% Confidence Interval|Median
1284645|NCT00202644|Secondary|Percentage of Participants With Partial Response|A partial response is defined as a platelet count of 400-600 x 10^9/Liter and a reduction in platelet count of at least 200 x 10^9/Liter from baseline which was confirmed over 2 consecutive visits at least 28 days apart.|Baseline up to Month 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||percentage of participants|||Number
1284646|NCT00202644|Secondary|Percentage of Participants With Complete Response|A complete response was defined as a platelet count of less than (<) 400x10^9/Liter which was confirmed over 2 consecutive visits at least 28 days apart.|Baseline up to Month 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||percenatge of participants|||Number
1284647|NCT00202644|Secondary|Change From Baseline in Platelet Counts at Month 3 and 36|Platelet count was evaluated throughout the study.|Baseline and Month 3 and 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded with last observation carried forward (LOCF). Here, n=number of participants analysed for specified category at specified time points in each arm respectively.|||10^9 platelets per liter||Standard Deviation|Mean
1284648|NCT00202644|Primary|Platelet Count at Month 6|Platelet count was evaluated.|Month 6|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, N = Number of participants analysed in each arm for this outcome measure.|||10^9 platelets per liter||Standard Deviation|Mean
1284649|NCT00202644|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time|The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function.|Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36|The Full Analysis Set (FAS) population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively.|||percentage of ejection fraction||Standard Deviation|Mean
1284650|NCT00202449|Primary|Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from baseline to Week 12.|Baseline to Week 12|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).|||scale points||Standard Deviation|Mean
1284651|NCT00202449|Primary|Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 12.|Baseline to Week 12|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at Week 12 (e.g., completed the study).|||scale points||Standard Deviation|Mean
1284652|NCT00202449|Primary|Change in Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12|"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 12. Minimum = 0 Maximum = 8"|Baseline and Week 12|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).|||scale points||Standard Deviation|Mean
1284653|NCT00201877|Secondary|Correlative Studies||During induction (weeks 1-15); PK every 2 months during maintenance.|Data not collected and analyzed||||||
1284654|NCT00201877|Secondary|Progression-free Survival(PFS)|To correlate serial plasma rituximab levels with response and progression-free survival.|2 years||||percentage of patients||95% Confidence Interval|Number
1284657|NCT00201864|Secondary|Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels||Prestudy, Day 7 and Day 120|Increase in mean levels from baseline to day 120. Not all patients had the IGF-1 and IGFBP-3 levels present.|||ng/mL||Standard Deviation|Mean
1284659|NCT00201864|Secondary|Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)|"Response and progression was evaluated after every 2 cycles by physical examination and imaging studies using the international RECIST criteria.~Complete Response (CR), Partial Response (PR), Overall Response Rate (ORR), Stable Disease (SD), Progressive Disease (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions; Overall Response Rate (ORR), CR+PR"|Every 2 cycles, up to 1 year||||patients|||Number
1284660|NCT00201864|Primary|Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.|TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 2 cycles up to 2 years||||months||95% Confidence Interval|Median
1284661|NCT00201851|Primary|Disease-free Survival|5-year disease-free survival|two- to three-year accrual and initial two or more years of follow-up period||||percentage of participants|||Number
1284662|NCT00201838|Secondary|Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines||up to 6 months|Compare CBR with responders and non responders with available blood samples.|||delta Ct values||Standard Deviation|Mean
1284663|NCT00201838|Secondary|Median Overall Survival Rates for Patients|Median survival is defined as the time of initiation of the first dose of intervention to the date of death|up to 1 year|all evaluable patients|||months||95% Confidence Interval|Median
1284664|NCT00201838|Secondary|Percentage of Patients With Clinical Benefit Response|A clinical benefit was defined by the improvement of at least one parameter over at least 4 weeks, without worsening of any other parameter (change in weight, ECOG performance status, Quality of life).|Up to 12 months|All evaluable patients|||percentage of patients|||Number
1284665|NCT00201838|Secondary|Number of Patients With Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 months|"2 patients in the control group were non evaluable for disease response due to patient withdrawal and another no baseline imaging for comparison.~5 patients in experimental group were non evaluable for response."|||percentage of patients|||Number
1284666|NCT00201838|Primary|Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Percentages were calculated by a Kaplan Meier analysis.|up to 6 months|5 patients of the experimental group were non evaluable and 2 patients in the control group were non evaluable for disease progression.|||percent of patients with PFS|||Number
1284667|NCT00201825|Secondary|Pharmacokinetics||Cycle 2|No Pharmacokinetics were conducted for this trial.||||||
1284668|NCT00201825|Secondary|One Year Survival||one year||||months||95% Confidence Interval|Median
1284669|NCT00201825|Secondary|Time to Tumor Progression||Every 35 days||||months||95% Confidence Interval|Median
1284670|NCT00201825|Primary|Determine Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 35 days|One patient was not evaluable for response because the patient was removed from study afer an adverse event.|||patients|||Number
1284671|NCT00201773|Secondary|Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women.|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, <30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 16 weeks|Clinical Response was determined by physical exam and breast Ultrasound at baseline and repeated at 8 weeks and 16 weeks, and pathological response by histopathological examination of primary tumor and axillary nodes after definitive breast cancer surgery.|||patients|||Number
1284672|NCT00201773|Primary|Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane|Collected from postmenopausal women that receive neoadjuvant exemestane.|up to 16 weeks|Comparison of immunohistochemistry (IHC) Allred Differences with Neoadjuvant Therapy|||patients|||Number
1284673|NCT00201760|Secondary|Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations|Adverse Events will be graded in accordance with the CTCAE Version 3.0 Toxicity grading criteria|Up to 24 months|Grades 3 and Grade 4|||patients|||Number
1284674|NCT00201760|Secondary|Measure Response Rate of Each Drug Combination|Response rate of the of the triple drug combination therapy and the double drug combination therapy regimens.|Up to 24 months||||patients|||Number
1284675|NCT00201760|Primary|Disease Progression|Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment|6 months||||Participants|||Count of Participants
1284676|NCT00201734|Secondary|Time to Tumor Progression for Patients|For patients enrolled on the Phase II portion of the trial the time to progression was measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression.|Up to 6 years||||months||95% Confidence Interval|Median
1284678|NCT00201734|Secondary|Progression-Free Survival at 6 Months for Patients|For patients enrolled on the Phase II portion of the trial Progression Free Survival (PFS) was measured from the percentage of patients that were still alive, without evidence of disease progression for 6 months following the initiation of treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 6 years||||percent of patients||95% Confidence Interval|Number
1284679|NCT00201734|Secondary|Phase I: To Determine Side Effects|The common clinically significant grade 3 and 4 toxicities graded using the National Cancer Institutes Common Toxicity Criteria version 3.0|Every 3 weeks, for up to 24 weeks|Three patients enrolled on Phase I portion of trial were not evaluable for toxicity.|||percent of patients|||Number
1284680|NCT00201734|Primary|Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 3 weeks, for up to 24 weeks|The Phase II study was prematurely terminated at 25 patients due to cessation of funding|||percent of patients||95% Confidence Interval|Number
1284681|NCT00201734|Primary|Maximum Tolerated Dose in Phase I Portion of Study|Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin.|Every 3 weeks, for up to 24 weeks||||mg/m2|||Number
1284682|NCT00201643|Secondary|Maternal Infectious Morbidity.|Total number of Mothers having Maternal infectious morbidity (e.g. endometritis & maternal sepsis) noted from birth through 28 days after birth|Up to 28 days after giving birth|ITT|||participants|||Number
1284683|NCT00201643|Secondary|Number of Neonates With Pneumothorax|Total number of neonates with pneumothorax diagnosed postpartum.|birth to 28 days of life|ITT|||participants|||Number
1284684|NCT00201643|Secondary|Number of Neonates Who Required Surfactant Therapy After Birth.|The Number of neonates who required surfactant therapy within the first 28 days after birth.|Birth to 28 days of life|ITT|||participant|||Number
1284685|NCT00201643|Secondary|Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.|The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day.|birth to 28 days of life|Intent to treat (ITT)|||participants|||Number
1284686|NCT00201643|Secondary|Neonatal Head Circumference Taken at Time of Birth.|Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group.|Birth|Intent to treat|||centemeters (cm)||Standard Deviation|Mean
1284687|NCT00201643|Secondary|Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.|Noted as the total number of Neonates delivering at < 34 weeks gestation for which their weights fell within the 10th percentile at time of birth.|Measured at birth.|Intent to Treat|||paticipants|||Number
1284688|NCT00201643|Secondary|Neonatal Birth Weight Reported in Grams|Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record.|At time of Birth|Intent to treat protocol|||grams||Standard Deviation|Mean
1284689|NCT00201643|Secondary|Gestational Age at (@) Delivery|Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo).|gestational age at delivery in weeks of gestation|Modified intent to treat|||Weeks||Standard Deviation|Mean
1284690|NCT00201643|Primary|Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.|This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at < 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death|From birth to 28 days of life|This was an intent to treat protocol. In patients delivering before 34 weeks we estimated that the sample size of at least 217 subjects in each arm would be needed to have 80% power to detect a 40% reduction in neonatal morbidity (to 16.8%).|||participants|||Number
1284691|NCT00201448|Primary|Immunology Response|The primary objective of the study is to evaluate safety and immune responses induced by the Towne vaccine in in seronegative women with children in daycare|Urine, saliva, will be collected every 2 months for 12 months and serum will be collected 1,2,4,6, 9, 12, 18, 24, 30 and 36 months after vaccination.|Study was terminated (suspended due to lack of funding). PI is no longer with the institution; data and results cannot be accessed, analyzed, and reported.||||||
1284692|NCT00201448|Primary|Participants With Adverse Events||One year|per protocol and randomized|||participants|||Number
1284693|NCT00201409|Secondary|Days Without Organ Failure|Non-respiratory|Measured at Day 28||||days||Standard Deviation|Mean
1284694|NCT00201409|Secondary|Oxygenation Index Change at Day 15 From Day 1|The oxygenation index is a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body. It is calculated as the fraction of inspired oxygen times Mean airway pressure)/Partial pressure of oxygen in arterial blood Day 15 minus first day drug or placebo administered (Day 1).|Day 1, Day 15||||oxygenation index||Standard Deviation|Mean
1284695|NCT00201409|Primary|Ventilator-free Days During Days 1-28||Measured at Day 28||||Days||Standard Deviation|Mean
1284696|NCT00201240|Secondary|Post-transplant Lymphoproliferative Disorder (PTLD)|PTLD is defined as increased Epstein Barr Virus viremia requiring clinical intervention.|Year 2||||participants|||Number
1284697|NCT00201240|Secondary|CD34+ and CD3+ Cell Doses|Total CD34+ and CD3+ cell doses will be calculated based on results of flow cytometric analysis.|Day 0||||cells per kilogram||Full Range|Median
1284698|NCT00201240|Secondary|Overall Survival|Overall survival is defined as time from transplant to death or last follow-up.|Months 12 and 36||||percentage of participants||95% Confidence Interval|Number
1284699|NCT00201240|Secondary|Disease-free Survival (DFS)|DFS is defined as the minimum time interval of times to relapse/recurrence, to death or to the last follow-up, from the time of transplant.|Months 6, 12, and 36||||percentage of participants||95% Confidence Interval|Number
1284700|NCT00201240|Secondary|Determination of Infusional Toxicity||28 day|No data collected||||||
1284704|NCT00201240|Secondary|Graft Failure|Primary graft failure is defined as the failure to achieve an ANC > 500 cells/µL by Day +30. Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in neutrophil counts < 500 cells/µL, unresponsive to growth factor therapy.|Day 100||||participants|||Number
1284705|NCT00201240|Secondary|Platelet Engraftment|Time to platelet engraftment is measured by determining the first of three consecutive measurements of platelet count ≥ 20,000/uL without platelet transfusion support for seven days, starting from Day 0.|6 Months||||days||Full Range|Median
1284706|NCT00201240|Secondary|Neutrophil Engraftment|Time to neutrophil engraftment is measured by determining the first of three consecutive measurements of absolute neutrophil count ≥ 500/uL following conditioning regimen induced nadir, starting from Day 0.|28 day||||days||Full Range|Median
1284707|NCT00201240|Secondary|Leukemia Relapse|To assess the incidence of acute leukemia relapse from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval. Death prior to relapse will be considered as a competing risk.|Months 12 and 36||||percentage of participants||95% Confidence Interval|Number
1284708|NCT00201240|Primary|Probability of Disease-free Survival (DFS) at 6 Months Post-transplant (Death or Relapse Will be Considered Events for This Endpoint)|The primary analysis will consist of estimating the 6-month DFS (from day of enrollment) probability based on the Kaplan-Meier product limit estimator. The 6-month DFS probability and confidence interval will be calculated. All registered patients will be considered for this analysis.|6 months|All transplanted patients|||percentage of patients||95% Confidence Interval|Number
1284709|NCT00201201|Secondary|Satisfaction With the APRN Provider Relationship|The Healthcare Relationships Scale assesses the perceived communication relationship with a provider. The 5-item instrument, based on two qualitative studies addresses patient-provider communication (2 questions), trust, decision-making related to care, and satisfaction with care. The scale was modified for use with older adults by changing the visual analog 10 cm response format to 5-point Likert-type responses with two extremes (e.g., 1:“not at all easy” to 5: “very easy”).|Measured at 0, 12 weeks on visit 1 and 4|There 69 participants in the control group and 82 participants in the education intervention group who chose to complete the satisfaction with the APRN provider on visit one and 65 in the control group and 75 in the education intervention group who chose to complete the survey on visit 4.|||units on a scale of 1-5||Standard Deviation|Mean
1284710|NCT00201201|Secondary|Satisfaction With the PEP-NG|"The PEP-NG user Satisfaction scale is a 14-item instrument – with eight items addressing the ease of program use, program content, and suitability of program content – and another six items addressing the intent to change behavior following program use. Ratings reflected by the 5-point Likert-type scale (ranging from 1, strongly disagree to 5, strongly agree) were summed and divided by the number of items answered to ensure that the overall Satisfaction scale was not affected by omitted items and was cast in the original 5-point metric. The higher the score on the instrument, the higher the degree of satisfaction with the PEP-NG."|Measured at 12 weeks||||units on a scale||Standard Deviation|Mean
1284711|NCT00201201|Secondary|Prescription/Over the Counter (Rx-OTC) Knowledge|The OTC-Rx Knowledge scale has 14 multiple-choice items and the score is the percent of the items with correct response (range: 0-100%; these items test both knowledge and application concerning potential adverse effects of self-medication with OTC agents, supplements, or alcohol in persons with hypertension. The higher the score, the higher the knowledge of the potential adverse effects from self-medication.|Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4||||percentage of questions correct||Standard Deviation|Mean
1284712|NCT00201201|Secondary|Self-efficacy for Avoiding Adverse Self-medication Behaviors|"The Self-efficacy scale is a 12-item instrument with statements reflecting patient confidence in selecting appropriate OTC agents and supplements, aside from avoiding adverse effects arising from self-medication behaviors. This scale has 5-point self-report response categories (ranging from 1, Not Sure to 5, Totally Sure). Responses were summed and divided by the number of items answered, so that the overall score would not be affected by omitted items and was reported based on the original 5-point metric. The higher the score on the instrument, the higher the degree of self-efficacy for avoiding adverse self-medication behaviors."|Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4||||units on a scale||Standard Deviation|Mean
1284713|NCT00201201|Primary|Blood Pressure (BP) Readings: Systolic Blood Pressure|BP measurements were taken by the APRN at each of 4 visits – at the beginning of PEP-NG use on visit 1, and post-PEP-NG use on subsequent visits.|Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4||||mm Hg||Standard Deviation|Mean
1284714|NCT00201201|Primary|Behaviors Risk Score|"Using a five-point scale from 1, very unlikely to 5, very likely, a five-member expert panel rated a list of adverse self-medication behaviors. The weight of each behavior was the mean of the expert ratings. Adverse self-medication behaviors were identified from questions that address use of medications (in the past month) to treat high blood pressure as well as use of OTC agents and alcohol for common problems that were self-treated with non-prescription agents. Participants were also asked if they drank alcoholic beverages, smoked or used nicotine, or took any vitamin or mineral supplements (including what, when and how frequently each was taken). The Adverse Self-Medication Behavior Risk Score is the sum (range 3 - 60) of the scores for the adverse behaviors identified. The higher the score, the higher the risk is for adverse self-medication behaviors."|Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4||||units on a scale||Standard Deviation|Mean
1284715|NCT00201123|Secondary|Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels||16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.|||cells/mL||Inter-Quartile Range|Median
1284716|NCT00201123|Secondary|Chest Cavity Size||16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.|||millimeters||Standard Deviation|Mean
1284717|NCT00201123|Primary|Sputum Conversion||Measured at 16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.|||percentage of participants|||Number
1284718|NCT00201006|Primary|Change in Body Weight.|Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.|one year|Data from all randomized participants were analyzed according to the Intent to Treatment principle. Missing data (6%) were completed based on known pattern of weight regain (i.e., 0.3 kg per month).|||kg||Standard Error|Mean
1284719|NCT00200967|Secondary|Asthma Control Questionnaire (ACQ)|Change between placebo salmeterol and active salmeterol for ACQ, where ACQ ranges from 0 (best asthma control) to 6 (worst asthma control).|Clinic visits at weeks 0 and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||units on a scale||95% Confidence Interval|Least Squares Mean
1284720|NCT00200967|Secondary|Methacholine Provocative Concentration 20 (PC20)|Change between placebo salmeterol and active salmeterol for methacholine PC20|Clinic visits at weeks 0 and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||milligrams per milliliter||95% Confidence Interval|Geometric Mean
1284721|NCT00200967|Secondary|Exhaled Breath Condensate (EBC)|Change between placebo salmeterol and active salmeterol for EBC|Clinic visits at weeks 0, 10, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||pH||95% Confidence Interval|Least Squares Mean
1284722|NCT00200967|Secondary|Exhaled Nitric Oxide (eNO)|Change between placebo salmeterol and active salmeterol for eNO|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||parts per billion||95% Confidence Interval|Geometric Mean
1284723|NCT00200967|Secondary|Spirometry Peak Expiratory Flow (PEF) Rate, Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters per minute||95% Confidence Interval|Least Squares Mean
1284724|NCT00200967|Secondary|Spirometry Forced Vital Capacity (FVC), Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters||95% Confidence Interval|Least Squares Mean
1284725|NCT00200967|Secondary|Spirometry Forced Expiratory Volume in One Second (FEV1), Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters||95% Confidence Interval|Least Squares Mean
1284726|NCT00200967|Secondary|Rescue Medication (Ipratropium and Albuterol) Use|Change between placebo salmeterol and active salmeterol for rescue medication use|Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||puffs per day||95% Confidence Interval|Mean
1284727|NCT00200967|Secondary|Asthma Symptoms|Change between placebo salmeterol and active salmeterol for asthma symptoms (0=absent, 1=mild, 2=moderate, 3=severe).|Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||units on a scale||95% Confidence Interval|Mean
1284728|NCT00200967|Secondary|Peak Expiratory Flow (PEF) Variability|Change between placebo salmeterol and active salmeterol for PEF variability, where PEF variability is defined as 100% x (PM PEF - AM PEF)/(PM PEF)|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||percentage||95% Confidence Interval|Least Squares Mean
1284729|NCT00200967|Secondary|Evening (PM) Peak Expiratory Flow (PEF) Rate|Change between placebo salmeterol and active salmeterol for PM PEF rate|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters per minute||95% Confidence Interval|Least Squares Mean
1284730|NCT00200967|Primary|Morning (AM) Peak Expiratory Flow (PEF) Rate|Change between placebo salmeterol and active salmeterol for AM PEF rate|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An intention-to-treat (ITT) paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters per minute||95% Confidence Interval|Least Squares Mean
1284731|NCT00200785|Secondary|Electrical Impedance in Ohms|Electrical impedance (ohms) was measured using 0.5 mL of whole blood plus 0.5 mL saline in a Chronolog Whole Blood aggregometer. Ten mL of whole blood were collected and tested every week. There is no mathematical correlation between impedance (ohms) and percent aggregation.|4 weeks|"Nine persons participated in the high allicin test. Six of the same persons participated in the no allicin test."|||ohms||Standard Deviation|Mean
1284732|NCT00200785|Primary|Percent Platelet Aggregation|percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)|4 weeks||||percent platelet aggregation||Standard Deviation|Mean
1284733|NCT00200356|Secondary|Modified Rankin Scale Score|The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|6 months||||participants|||Number
1284734|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 3 Months|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.|3 months||||units on a scale||Standard Deviation|Mean
1285759|NCT00186069|Secondary|Neonatal Apgar Score at 5 Minutes|The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status.|At 5 minutes after birth||||Apgar score||Full Range|Median
1284735|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 1 Month|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.|1 month||||units on a scale||Standard Deviation|Mean
1284736|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 14 Days|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.|14 days||||units on a scale||Standard Deviation|Mean
1284737|NCT00200356|Secondary|NIH Stroke Scale Score at 3 Months|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.|3 months||||participants|||Number
1284738|NCT00200356|Primary|the Rate of Patients With a Modified Rankin Scale Score of 0-1|The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|3 months||||participants|||Number
1284739|NCT00200356|Secondary|NIH Stroke Scale Score at 1 Month|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.|1 month||||participants|||Number
1284740|NCT00200356|Secondary|NIH Stroke Scale Score at 14 Days|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.|14 days||||participants|||Number
1284741|NCT00200356|Secondary|Baseline NIH Stroke Scale Score|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).|Before treatment initiation||||scores on a scale||Standard Deviation|Mean
1284742|NCT00200356|Secondary|Barthel Index Score|"The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.~The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation."|3 months||||participants|||Number
1284743|NCT00200343|Secondary|Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|||Percentage of change||Full Range|Median
1284744|NCT00200343|Primary|Percentage Change of Alanine Aminotransferase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|||Percentage of change||Full Range|Median
1284745|NCT00200343|Secondary|Gamma-glutamyl Transpeptidase at Baseline||0 week||||IU/L||Standard Deviation|Mean
1284746|NCT00200343|Secondary|Percentage Change of Aspartate Aminotransferase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)||||Percentage of change||Full Range|Median
1284747|NCT00200343|Secondary|Aspartate Aminotransferase at Baseline||0 week||||IU/L||Standard Deviation|Mean
1284748|NCT00200343|Primary|Alanine Aminotransferase at Baseline||0 week|10 patients were excluded from analysis population due to luck of sufficient data.|||IU/L||Standard Deviation|Mean
1284749|NCT00200161|Secondary|To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes.||through study completion, an average of 1 year|Data were not collected||||||
1284750|NCT00200161|Secondary|Prognostic Impact of Methylated MGMT Status.|MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR.|through study completion, an average of 1 year|Data were not collected||||||
1284751|NCT00200161|Secondary|Progression Free Survival at 6 Months||6 months||||percentage of participants|||Number
1284752|NCT00200161|Primary|12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.||until death or date of last follow up, an average of 12 months||||percentage of participants|||Number
1284753|NCT00200057|Secondary|Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week|"This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months."|Baseline and 12 months|All subjects who were successfully implanted were included in this analysis. The modified worst-case analysis for missing data was used, so that all subjects with missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.|||proportion of subjects||95% Confidence Interval|Mean
1285760|NCT00186069|Secondary|Gestational Age at Delivery (Weeks)|Median gestational age at delivery (in full weeks)|Time of delivery||||weeks of gestation||Full Range|Median
1284754|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.|||units on a scale||Standard Deviation|Mean
1284755|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.|||units on a scale||Standard Deviation|Mean
1284756|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.|||units on a scale||Standard Deviation|Mean
1284757|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.|||units on a scale||Standard Deviation|Mean
1284758|NCT00200057|Secondary|Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week|"This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months."|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.|||proportion of subjects||95% Confidence Interval|Mean
1284759|NCT00200057|Primary|Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week|"The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months."|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.|||proportion of subjects||95% Confidence Interval|Mean
1284760|NCT00199914|Secondary|Adverse Events||3 weeks|||||||
1284761|NCT00199914|Secondary|Patient's Satisfaction to the Treatment||3 weeks|||||||
1284762|NCT00199914|Secondary|Global Improvement||3 weeks|||||||
1284763|NCT00199914|Secondary|Gait Speed (Calculated From the Time Spending for 100-meter Walk)||3 weeks|||||||
1284764|NCT00199914|Primary|The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index|The WOMAC index is a multidimensional, self-administered health status evaluation instrument for patients with OA of the hip and knee. It is composed of 24 items that are grouped into three dimensions, including pain (5 items), stiffness (2 items), and function (17 items). The response can be in a form of visual analog or five-point Likert scale [11, 23]. In this study, the response is on a 10-cm horizontal line with numeric description from 0 to 10. The score of each dimension is an average of the component item scores. The WOMAC total score is determined by averaging the scores of all dimensions. The total score ranges from 0 (best outcome possible) to 10 (worst outcome possible).|3 weeks|Statistical analyses to test the superiority were based on the intention-to-treat (ITT) population, and those chosen to demonstrate the equivalence were based on the per protocol population. The “worst –case-scenario” was applied to the dropouts in the ITT analyses.|||units on a scale||95% Confidence Interval|Mean
1284765|NCT00199875|Secondary|Number of Patients With Samples Collected for Evaluation of Human Antichimeric Antibody|Blood samples were drawn for evaluation of the human antichimeric antibody (HACA) at screening, between Days 22 and 28, between Days 36 and 42, between Days 43 and 57 or at the end of study, and during long-term follow-up (approximately 12 weeks later). Serial dilutions were tested by the enzyme-linked immunosorbent assay (ELISA) using the “double antibody sandwich” technique and pretreatment serum as negative control.|Up to 6 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1284766|NCT00199875|Secondary|Number of Patients Who Met Protocol-Specified Criteria to Receive ^90-Y-DOTA-cG250 Following ^111In-DOTA-cG250 Administration|In order to receive the therapeutic ^90Y-DOTA-cG250 injection on Day 8, 9, or 10, patients must have demonstrated tumor targeting to lesions > 2 cm detected by CT scan and must not have exhibited the following characteristics following the nontherapeutic injection of ^111In-DOTA-cG250: excessive liver and/or spleen uptake; excessive uptake in the normal kidney; non-visualization of the cardiac blood pool in the first imaging set; whole body clearance half-life (t1/2) < 1.5 days; serum t1/2 < 2 days; rapid clearance of the radiopharmaceutical from the blood pool with prominent marrow uptake on the first image.|Up to 5 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1284767|NCT00199875|Primary|Number of Patients With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as follows for the purposes of dose escalation: Grade 4 hematopoietic toxicity in excess of 5 days or Grade 3 or greater nonhematopoietic toxicity.|Continuously for up to 5 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1284768|NCT00199381|Primary|Safety as Measured by Adverse Events|Investigation of the long-term tolerability and safety of istradefylline|Every 2 months up to 32 months|Safety analysis set - all subjects who took at least one dose of study drug. 1 subject of the 504 enrolled did not take study drug and is not included in the safety analysis set.|||participants|||Number
1284769|NCT00198822|Secondary|Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)||Third trimester of pregnancy (about the 32nd week of gestation)||||micromoles per liter||Standard Deviation|Mean
1284770|NCT00198822|Primary|All-cause, Pregnancy-related Mortality|Mortality evaluated on intent-to-treat basis|Deaths during pregnancy through 12 weeks postpartum|As the study ended on the advice of the Data and Safety Monitoring Board, based on evidence of no difference, all enrolled women who had a chance of being followed through 84 days after the end of their pregnancy were included in the trial. The cohort included pregnancies identified between August 17, 2001 and January 5, 2006.|||Participants|||Number
1284771|NCT00198822|Secondary|Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)||Third trimester of pregnancy (about the 32nd week of gesatation)||||Plasma beta-carotene micromoles / liter||Standard Deviation|Mean
1284772|NCT00198822|Secondary|Infant Morbidity Through 3 Months of Age||within 24 weeks after birth|||||||
1284773|NCT00198822|Secondary|Fetal Growth and Postnatal Infant Growth Through Three Months of Age||through the 1st 12 weeks after birth|||||||
1284774|NCT00198822|Secondary|Gestational Age at Birth||within 24 weeks after birth|||||||
1284775|NCT00198822|Secondary|Maternal Morbidity, Including Obstetric Complications||through the 1st 24 weeks following termination of pregnancy|||||||
1284776|NCT00198822|Secondary|All-cause 3-month Infant Mortality||Deaths through the 1st 12 weeks of life|Mortality evaluated on intent-to-treat basis|||participants|||Number
1284777|NCT00198133|Secondary|Grade 3/4 Treatment Related Adverse Events|To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).|Up to 3 years|All patients enrolled and received treatment|||participants|||Number
1284778|NCT00198133|Secondary|Duration of Remission|Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.|Time from the date of remission until progression or death, assessed up to 3 years|All patients with at least one post baseline measurement who had a response of CR or PR|||months||95% Confidence Interval|Median
1284779|NCT00198133|Primary|Objective Response Rate (Complete and Partial Response)|The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.|Up to 3 years|All patients with at least one post baseline measurement. (26 evaluable – 15 T and 11 TC patients)|||percentage of participants||95% Confidence Interval|Number
1284780|NCT00198081|Primary|Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months||||pg/ml|||Number
1284781|NCT00198081|Primary|Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months||||pg/ml|||Number
1284782|NCT00198081|Primary|Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months||||pg/ml|||Number
1284783|NCT00198081|Secondary|Number of Participants With Clinical Changes in IPMN Progression.|Examine the short term effect of celecoxib on clinical progression of IPMN in the surgical arm; Examine the long term effect of celecoxib on clinical progression of IPMN in the medical arm.|Baseline, 6 months, 1 year|Data never collected for surgical arm; medical arm of study never initiated.||||||
1284784|NCT00198081|Primary|Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months||||pg/ml|||Number
1284785|NCT00198042|Other Pre-specified|Bone Tunnel Cross Sectional Area||2 years|||||||
1284786|NCT00198042|Primary|Bone Tunnel Diameter|Bone tunnel diameter measured on MRI|2 years|MRI measurement of tunnel dimensions.|||mm||Standard Deviation|Mean
1284863|NCT00197106|Secondary|Cumulative Number of Symptom-free Weeks Until the End of Treatment|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||||||
1284787|NCT00198029|Secondary|Visual Analog Scale for Pain|The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.|26 weeks (6 months)||||mm||Standard Deviation|Mean
1284788|NCT00198029|Primary|The Disabilities of the Arm, Shoulder and Hand Outcome Measure|The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.|26 weeks (6 months)||||units on a scale||Standard Deviation|Mean
1284789|NCT00197496|Secondary|Lower Extremity Functional Scale||discharge||||units on a scale||Standard Deviation|Mean
1284790|NCT00197496|Secondary|2 Minute Walk Test||discharge||||metres||Standard Deviation|Mean
1284791|NCT00197496|Secondary|Falls Self Efficacy||discharge||||units on a scale||Standard Deviation|Mean
1284792|NCT00197496|Secondary|Timed up and Go||discharge||||seconds||Standard Deviation|Mean
1284793|NCT00197496|Primary|Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up|Compliance to BWSTT only,|3 months||||Participants|||Count of Participants
1284794|NCT00197392|Secondary|Number of Catheter Insertion Attempts|Number of insertions needed to place catheter|Implantation of subject||||insertions|||Number
1284795|NCT00197392|Secondary|Length of Catheter Tunneling Into the Brain|Length of tunneling of EVD catheter in the brain for each analysis population.|Implant of subject||||cm||Standard Deviation|Mean
1284796|NCT00197392|Secondary|Hospital Locations for EVD Catheter Placement|Number of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).|Implantation of subject||||Participants|||Number
1284797|NCT00197392|Secondary|Time Point of Introduction of Systemic Antibiotic Therapy|Time points of then patients received systemic antibiotic therapy|Within 48 hours of implant of subjects to explant||||Paticipants|||Number
1284798|NCT00197392|Secondary|Non-infectious Catheter Failure in the MITT Population|Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.|Implant of subject to explant||||Participants|||Number
1284799|NCT00197392|Secondary|Diagnosis Requiring EVD Implantation|Primary diagnosis for implantation of EVD system|Implantation of EVD system|Analysis consisted of combining both Arm/Group (Bactiseal and Standard)|||Participants|||Number
1284800|NCT00197392|Secondary|Average Subject Age|The average subject age|Implant to subject||||Years||Standard Deviation|Mean
1284801|NCT00197392|Secondary|Number of Days With Indwelling Catheter|Days catheter was implanted in subjects|Implant of subjects to day of explant||||Days||Standard Deviation|Mean
1284802|NCT00197392|Secondary|Device Related Adverse Events|Number of Device Related Adverse Events|Implanted subjects to time of explant|There were 8 device-related events, 7 of which were in subjects that received a standard catheter. None of the 8 subjects were proven infections.|||events|||Number
1284803|NCT00197392|Secondary|Intraluminal Colonization on Catheters|Number of catheters with Bacterial colonization verified using fluorescence.|Implant of subjects to post implant||||catheters|||Number
1284804|NCT00197392|Secondary|Class of Bacterial Agent Causing Proven Infection|Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD|Implantation of subject to post implant|All subjects included in the MITT, Evaluable and Per-Protocol population.|||participants|||Number
1284805|NCT00197392|Secondary|Days to Proven Infection|Number of days to proven infection.|Implantation of EVD System to explant of EVD catheter, an average of ten days||||Days||Standard Deviation|Mean
1284806|NCT00197392|Primary|Number of Infections|The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).|Duration of implanted EVD system to 2 week post implant||||Infections|||Number
1284807|NCT00197236|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events|Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.|Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.|The analyses were performed on the Total Vaccinated Cohort for the active phase of the study and on the Extended safety follow-up cohort for the 6-month extended follow-up (ESFU) phase.|||Participants|||Count of Participants
1284808|NCT00197236|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|31-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort|||Participants|||Count of Participants
1284809|NCT00197236|Secondary|Number of Subjects Reporting Solicited General Adverse Events (AEs)|Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.|4-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1284810|NCT00197236|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs)|Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.|4-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1284811|NCT00197236|Secondary|Number of Subjects With Vaccine Response to Havrix™.|Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.|31 days following the second dose|Analysis was performed on the According-to-Protocol cohort for immunogenicity|||Participants|||Count of Participants
1284812|NCT00197236|Secondary|Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix|Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).|31 days following the second dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284813|NCT00197236|Secondary|Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix|Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).|31 days following the first dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284814|NCT00197236|Secondary|Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix|Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).|31 days following the first dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.|||Participants|||Count of Participants
1284815|NCT00197236|Secondary|Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)|Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||Participants|||Count of Participants
1284816|NCT00197236|Secondary|Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)|GMCs are expressed as microgram/milliliter (µg/mL).|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||µg/mL||95% Confidence Interval|Geometric Mean
1284817|NCT00197236|Secondary|Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)|GMCs are expressed as International Units per milliliter (IU/mL).|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||IU/mL||95% Confidence Interval|Geometric Mean
1284818|NCT00197236|Primary|Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)|Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||Participants|||Count of Participants
1284819|NCT00197236|Primary|Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects|Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||Participants|||Count of Participants
1284820|NCT00197236|Primary|Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix|Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).|31 days following the second dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity including subjects who had at least one study vaccine administered and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1284821|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|At least one month after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||Participants|||Count of Participants
1284822|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day follow-up period after additional vaccination.|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||Participants|||Count of Participants
1284823|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.|"Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.~Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination"|During the 4-day follow-up period after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||Participants|||Count of Participants
1284864|NCT00197106|Secondary|Frequency of Asthma Exacerbations (Discriminated on Severity)|The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.|26 weeks|||||||
1288799|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg|72-hour fasting Day 3 Leptin dose 0.3 mg/kg|3 DAY||||HR||Standard Deviation|Mean
1284824|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.~Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful"|during the 4-day follow-up period after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||Participants|||Count of Participants
1284825|NCT00197184|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From last study visit of the primary study up to Year 5 long term follow-up|The analysis was performed on the Long term Total vaccinated cohort wich included all subjects who returned at a specified follow-up study|||Participants|||Count of Participants
1284826|NCT00197184|Primary|Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.|Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).|Before and One month after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284827|NCT00197184|Primary|Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.|Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.|Before and one month after additional vaccination|None of the subjects became seronegative for anti-HAV antibodies during the Year 2 to Year 5 long term follow-up. Hence none of the subjects received an additional Havrix dose.||||||
1284828|NCT00197184|Primary|Anti-hepatitis B (HBs) Antibody Concentrations|Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).|Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)|Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284829|NCT00197184|Primary|Anti-hepatitis A (HAV) Antibody Concentrations|Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)|Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)|Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284830|NCT00197145|Secondary|Number of Participants With the Impact on Health Related Quality of Life Measured by Euro Quality of Life (Qol) Questionnaire During the Randomized Treatment Phase|The EuroQol is a standardized instrument for use as a measure of health related quality of life. It consists of two pages comprising the EuroQoL 5 Dimension 5 level (EQ-5D5) descriptive system and the EQ visual analogue scale (VAS). The EQ-5D5 comprises of five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety). Each dimension comprises five levels of response (no problems, mild problems, moderate problems, moderate to extreme problems, and extreme problems). The EQ VAS records the respondents self-rated health status on a vertical graduated (0 to 100) VAS. Higher score represented greater severity of diseases.|Up to Week 48|ITT Population. Data for this outcome measure were not collected due to early termination of the study.||||||
1284831|NCT00197145|Secondary|Number of Participants Who Were Bothered by Each of Several Specific Symptoms Evaluated Using the HIV Symptom Index Questionnaire During the Randomized Treatment Phase|The HIV Symptom Index Questionnaire was planned to be used to evaluate how bothersome certain symptoms were during the conduct of this clinical study. The participant self-report instrument had 20 items, each of which asked about a specific symptom or group of related symptoms that participants might have had during the past 4 weeks and the degree to which the participant is bothered by the symptom. The symptom index comprised 32 common and HIV-specific symptoms scored in terms of presence/absence (1, 0) and severity on a 4-point scale (0 = not at all to 3 =quite a bit). Higher score represented greater severity of symptoms.|Upto Week 48|ITT Population. Data for this outcome measure were not collected due to early termination of the study.||||||
1284832|NCT00197145|Secondary|Investigational Product Adherence Measured by Pill Counts|Adherence to investigational product was planned to be evaluated using pill counts of unused investigational product (blinded GW873140 or placebo, open-label GW873140 for open label phase). This assessment was planned to be conducted at each time the participant received a new (refill) supply of study medication.|Up to Week 48 of Randomized Treatment phase and up to Switch + 24 Weeks of the Open Labeled phase|ITT Population. Data for this outcome measure were not collected due to early termination of the study.||||||
1284833|NCT00197145|Secondary|Plasma GW873140 400 mg BID PK Parameter of Concentration at End of Dosing Interval (Trough Concentration [Cτ]) During the Randomized Treatment Phase|Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.|Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)|PK Population. Data were not collected for this outcome measure due to early termination of the study.||||||
1284865|NCT00197106|Secondary|Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)|Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.|26 weeks|||||||
1284834|NCT00197145|Secondary|Plasma GW873140 400 mg BID PK Parameter of Time of Maximum Observed Plasma Concentration (Tmax) During the Randomized Treatment Phase|Tmax is defined as the time at which Cmax is observed, determined directly from the raw concentration-time data. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.|Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)|PK Population. Data were not collected for this outcome measure due to early termination of the study.||||||
1284835|NCT00197145|Secondary|Plasma GW873140 400 mg BID PK Parameter of Maximum Observed Plasma Concentration (Cmax) During the Randomized Treatment Phase|Cmax is defined as the first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.|Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)|PK Population. Data were not collected for this outcome measure due to early termination of the study.||||||
1284836|NCT00197145|Secondary|Plasma GW873140 400 mg BID Pharmacokinetic (PK) Parameter of Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length (Tau) (AUC [0-tau]) During the Randomized Treatment Phase|AUC (0- tau) GW873140 was defined as the area under the plasma concentration-time curve from time 0 to tau. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24. It was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)|The PK Population was defined as all participants who received GW873140 and underwent plasma PK sampling during the study. Participants for whom plasma a PK sample was obtained and assayed were planned to be included in analyses of the PK population. Data were not collected for this outcome measure due to early termination of the study.||||||
1284837|NCT00197145|Secondary|Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline|The IC50 is a measure of the effectiveness of a substance in inhibiting a specific biological or biochemical function. IC50 was collected for abacavir (ABC), atazanavir (ATV), delavirdine (DLV), didanosine (DDI), efavirenz (EFV), emtricitabine, enfuvirtide , fosamprenavir (AMP), GW873140 (APL), indinavir (IDV), indinavir rooted with ritonavir (IDV/r), lamivudine, lopinavir rooted with ritonavir (LPV/r), nelfinavir (NFV), nevirapine (NVP), ritonavir (RTV), saquinavir (SQV), stavudine, tenofovir (TFV), tipranavir rooted with ritonavir (TPV/r), zidovudine (ZDV). Data is categorized for number of participants with each IC50 concentration of the individual drugs at Baseline (Day 1).|Baseline (Day 1)|ITT Population.|||Participants|||Count of Participants
1284838|NCT00197145|Secondary|Number of Participants With Development of Antiretroviral Resistance to GW873140 400 mg BID and Other Antiretroviral Drugs|Assessment for the development of antiretroviral resistance was performed at each visit up to Follow-up. The genotypic analysis of viral resistance associated mutations was done using protease and reverse transcriptase enzymes. The number of participants with treatment emergent changes in reverse transcriptase and protease genotypic mutations were reported.|Up to Follow-up (Week 52)|Virologic Failure Population was defined as the number of participants with protocol defined virologic failure criteria.|||Participants|||Count of Participants
1284839|NCT00197145|Secondary|Time to Centres for Disease Control and Prevention (CDC) Class C Acquired Immune Deficiency Syndrome (AIDS)-Defining Event or Death|The time to CDC class C AIDS-defining event or death was planned to be assessed as per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|Up to Week 12 Follow-up of the Randomized phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase|ITT Population. Data were not collected for this outcome measure due to early termination of the study.||||||
1284840|NCT00197145|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase|The CD4 cell count is an indication of the strength of the immune system. The assessment of CD4 cell count was done by flow cytometry. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12, 24 and 40) values.|Baseline (Day 1), Week 12, Week 24 and Week 40|ITT Population. Only those participants available at the specified time points were analyzed.|||Cells/Cubic millimeter (mm^3)||Standard Deviation|Mean
1284866|NCT00197106|Secondary|Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres|Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.|26 weeks|||||||
1288800|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg|72-hour fasting Day 3 Leptin dose 0.1 mg/kg|3 DAY||||NG*H/ML||Standard Deviation|Mean
1284841|NCT00197145|Secondary|Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase|12-lead ECG assessments were obtained at Day 1 (triplicate measurements), Week 4 and Week 24. The assessments were done using an ECG machine that automatically measured RR, PR, QRS, uncorrected QT, QTc (Bazette) and QTc (Fridericia) intervals. Baseline was defined as the mean of the triplicate assessment done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 4 and Week 24) values.|Baseline (Day 1), Week 4 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Millisecond (msec)||Standard Deviation|Mean
1284842|NCT00197145|Secondary|Change From Baseline in Electrocardiograph (ECG) Parameter of Heart Rate (HR) During the Randomized Treatment Phase|12-lead ECG assessments were obtained at Day 1 (triplicate measurements), Week 4 and Week 24. The assessments were done using an ECG machine that automatically calculated the heart rate. Baseline was defined as the mean of the triplicate assessment done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 4 and 24) values.|Baseline (Day 1), Week 4 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Beats per minute (Bpm)||Standard Deviation|Mean
1284843|NCT00197145|Secondary|Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
1284844|NCT00197145|Secondary|Change From Baseline in Haematology Parameter of Hematocrit During the Randomized Treatment Phase.|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of red blood cells||Standard Deviation|Mean
1284845|NCT00197145|Secondary|Change From Baseline in Haematology Parameter of Mean Corpuscle Volume (MCV) During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Femtoliter (FL)||Standard Deviation|Mean
1284846|NCT00197145|Secondary|Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Giga cells (GI)/L||Standard Deviation|Mean
1284847|NCT00197145|Secondary|Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||U/L||Standard Deviation|Mean
1284848|NCT00197145|Secondary|Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed|||Gram (g)/L||Standard Deviation|Mean
1284849|NCT00197145|Secondary|Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Micromole (UMOL)/L||Standard Deviation|Mean
1284850|NCT00197145|Secondary|Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimole (MMOL)/L||Standard Deviation|Mean
1284851|NCT00197145|Secondary|Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||International unit per liter (IU/L)||Standard Deviation|Mean
1284867|NCT00197106|Secondary|Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26|PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. From this population, only participants who had measurements at both baseline and Week 26 have been used for analysis.|||ratio||95% Confidence Interval|Log Mean
1284852|NCT00197145|Secondary|Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline|The participants with treatment emergent toxicities of laboratory abnormalities for chemistry data is reported . Participants with toxicities were categorized according to the division of AIDS (DAIDS) toxicity grading scale. Scale ranges from grade 1(mild)=symptoms causing no or minimal interference with usual social & functional activities, grade 2 (moderate)=symptoms causing greater than minimal interference with usual social & functional activities, grade 3 (severe)=symptoms causing inability to perform usual social & functional activities and grade 4 (potentially life threatening)=symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Scale ranges from 1-4, where higher grade reflects greater severity of symptoms. Baseline was defined as assessments done at Day 1. Only those parameters for which at least one value of toxicity grade was reported are summarized.|Up to Week 40|ITT Population.|||Participants|||Count of Participants
1284853|NCT00197145|Secondary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, hypersensitivity reaction to abacavir. AEs were classified as potentially drug-related, based on the investigator's judgment.|Up to Follow-up (Week 52)|ITT Population.|||Participants|||Count of Participants
1284854|NCT00197145|Secondary|Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48|Assessment for plasma HIV-1 RNA was done at Week 24 and also planned at Week 48 by PCR analysis. Data is reported for number of participants with plasma HIV-1 RNA <50 copies/mL at Week 24. Data was not collected for Week 48 due to early termination of the study.|Week 24|ITT Population. The analysis was an observed analysis and only participants with data available at the indicated timepoints were included.|||Participants|||Count of Participants
1284855|NCT00197145|Primary|Number of Participants With >= 1.0 log10 Copies/mL Decrease in Plasma HIV-1 RNA From Baseline Over Time|The plasma HIV-1 RNA polymerase chain reaction (PCR) assessments were planned at pre-Baseline (between 1 and 14 days prior to Day 1), up to Week 12 Follow- up of the Randomized Phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase, however the study was early terminated at Week 40. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values.|Day 1 up to Week 12 Follow-up of the Randomized Treatment phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase|ITT Population. Data were not collected for this outcome measure due to early termination of the study.||||||
1284856|NCT00197145|Primary|Average Area Under the Curve Minus Baseline (AAUCMB) of Plasma HIV-1 RNA Through the Entire Study Period|The area under the plasma HIV-1 RNA curve (AUC) was computed using the trapezoidal rule for all assessments (scheduled and unscheduled) at their actual time points. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values. Participants without a Baseline assessment was removed from the analysis. The AAUCMB was computed by the AUC divided by the duration of the profile (i.e., the number of days on randomized therapy) minus the Baseline measurement. Data is reported up to Week 40 only due to early termination of the study.|Up to Week 40|ITT Population. Only those participants available at the specified time points were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
1284857|NCT00197145|Primary|Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48|Assessment for plasma HIV-1 RNA was done at Week 24 and also planned at Week 48 by polymerase chain reaction (PCR) analysis. Data is reported for number of participants with plasma HIV-1 RNA <400 copies/mL at Week 24. Data was not collected for Week 48 due to early termination of the study.|Week 24|Intent to Treat (ITT) Population comprised of all participants randomized with evidence of receiving at least one dose of study medication. The analysis was an observed analysis and only participants with data available at the indicated timepoints were included.|||Participants|||Count of Participants
1284858|NCT00197119|Primary|Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From Year 6 through to Year 10||||subjects|||Number
1284859|NCT00197119|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value|Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.|Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination|Analysis was performed on the ATP cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.|||subjects|||Number
1284860|NCT00197119|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value|Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).|Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination|Analysis was performed on the Long Term According To Protocol (ATP) cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.|||subjects|||Number
1284861|NCT00197106|Secondary|Time to Asthma Control, Defined as the Time to First ‘Good Controlled Week’ or ‘Maximum Controlled Week'|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||||||
1284862|NCT00197106|Secondary|Weekly Percentage of Participants With ‘Good Controlled Weeks’ and ‘Maximal Controlled Weeks’|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||||||
1284868|NCT00197106|Secondary|Number of Asthma Exacerbations Per Treatment Group at Week 26|An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.|Week 26|Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication)|||number of exacerbations|||Number
1284869|NCT00197106|Secondary|Percent Change From Baseline in RINT Measurements at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.|Baseline and Week 26|PP Population: Intent-to-Treat (ITT) Population participants who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26). For some participants, the data for the RINT measurement are missing, either at Baseline or at Week 26. As a result, fewer subjects have been included in the analysis.|||percent|||Number
1284870|NCT00197106|Secondary|Geometric Means of Nitric Oxide (NO) at Week 26|Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26)|||parts per billion||Full Range|Geometric Mean
1284871|NCT00197106|Secondary|Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. For some participants, the data for the MEF 50 measurements are missing, resulting in a smaller number of participants analyzed.|||liters/second||Standard Deviation|Mean
1284872|NCT00197106|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.|||liters||Standard Deviation|Mean
1284873|NCT00197106|Secondary|Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.|||percent predicted change||Standard Deviation|Mean
1284874|NCT00197106|Secondary|Percentage of Symptom-free Days During the Entire Treatment Period|Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant’s diary|Baseline to Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations|||percentage of days||Standard Deviation|Mean
1284875|NCT00197106|Primary|Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period|Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant’s diary.|Last 10 weeks of the treatment period (Weeks 16-26)|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations|||percentage of days||Standard Deviation|Mean
1284876|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
1284877|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
1284878|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
1284879|NCT00197028|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).|During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
1284880|NCT00197028|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).|During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
1284881|NCT00197028|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site.|During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
1284882|NCT00197028|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site.|During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
1284883|NCT00197028|Secondary|Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia|The parasite density in subjects prevalent for P. falciparum parasitemia (subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 3 ½ months after administration of Dose 3 of RTS,S/AS02D or Engerix-B® vaccine (Month 6). Parasite density is expressed as mean, minimum and maximum density in parasite per µL.|At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.|||Parasites per µL||Full Range|Mean
1284884|NCT00197028|Secondary|Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum)|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.|At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.|||subjects|||Number
1284885|NCT00197028|Secondary|Time to First Malaria Infection|Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.|Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.|||n/PYAR|||Number
1284886|NCT00197028|Secondary|Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was 0.15 µg/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1284887|NCT00197028|Secondary|Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 15 EL.U/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1284900|NCT00197015|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, rash (local), redness and swelling.|During the 4-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects with available data.|||Participants|||Count of Participants
1284888|NCT00197028|Secondary|Concentrations of Antibodies Against Tetanus (Anti-T)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1284889|NCT00197028|Secondary|Concentrations of Antibodies Against Anti-diphtheria (Anti-D)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1284890|NCT00197028|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 0.5 EL.U/mL.|Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1284891|NCT00197028|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB)|Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection cut-off of the assay was 10 mIU/mL.|Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284892|NCT00197028|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|Throughout the entire study period (from Month 0 to Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||subjects|||Number
1284893|NCT00197028|Primary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||subjects|||Number
1284894|NCT00197015|Secondary|Number of Subjects Reporting Medically Significant Events|Medically significant events include, but are not limited to, diabetes, autoimmune disease, asthma, allergies and/or conditions prompting emergency room or physician office visits that are not related to well-child care, vaccination or common acute illnesses (e.g., upper respiratory infection, otitis media, pharyngitis, gastroenteritis, injury and visits for routine physical examination).|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).|||Participants|||Count of Participants
1284895|NCT00197015|Secondary|Number of Subjects Reporting New Chronic Illnesses|New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies.|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).|||Participants|||Count of Participants
1284896|NCT00197015|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
1284897|NCT00197015|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|During the 31-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
1284898|NCT00197015|Secondary|Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events|Specific adverse events assessed include papules, vesicles, crusts, parotid/salivary gland swelling and suspected signs of meningitis/febrile seizures.|During the 43-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects from MMR+V→HAV and HAV+MMR+V groups.|||Participants|||Count of Participants
1284899|NCT00197015|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general).|During the 4-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects with available data.|||Participants|||Count of Participants
1284901|NCT00197015|Secondary|Number of Subjects With Vaccine Response to Havrix®|Vaccine response was defined as: 1) a detectable anti-hepatitis A virus (HAV) antibody concentration 31 days following the second dose in subjects who were initially seronegative; and 2) a 2-fold increase in anti-HAV antibody concentrations above the pre-study concentration 31 days following the second dose in subjects who were initially seropositive.|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||Participants|||Count of Participants
1284902|NCT00197015|Secondary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group|Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.|||Participants|||Count of Participants
1284903|NCT00197015|Secondary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group|Concentrations are given as geometric mean concentrations (GMCs).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1284904|NCT00197015|Secondary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).|42 days following the first dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.|||Participants|||Count of Participants
1284905|NCT00197015|Secondary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups|Concentrations are given as geometric mean concentrations (GMCs).|42 days following the first dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1284906|NCT00197015|Secondary|Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups|Titers are given as geometric mean titers (GMTs).|42 days following the administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.|||titers||95% Confidence Interval|Geometric Mean
1284907|NCT00197015|Primary|Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).|42 days following administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.|||Participants|||Count of Participants
1284908|NCT00197015|Primary|Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.|42 days following the administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.|||Participants|||Count of Participants
1284909|NCT00197015|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.|||Participants|||Count of Participants
1284910|NCT00197015|Primary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups.|Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V Groups.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284911|NCT00197002|Secondary|Number of Subjects With SAEs, NCIs and MSEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose)|The analysis was performed on the ESFU cohort, which included all vaccinated subjects for whom safety data were available during the extended safety follow-up period (from Day 30 up to 6 months after last vaccine dose).|||Participants|||Count of Participants
1284922|NCT00197002|Secondary|Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations|Antibody concentrations against pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL).|At one month after Prevnar™ vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||μg/mL||95% Confidence Interval|Geometric Mean
1285050|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Response 100 (CR-100)|A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
1284912|NCT00197002|Secondary|Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
1284913|NCT00197002|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Day 0-30) follow-up period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
1284914|NCT00197002|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
1284915|NCT00197002|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
1284916|NCT00197002|Secondary|Number of Subjects With Vaccine Response to Anti-HAV Antibodies|"The vaccine response was defined as:~a detectable anti-HAV antibody concentration one month after Dose 2 in subjects who were initially seronegative (antibody concentrations < 15 mIU/mL for anti-HAV); or~a 2-fold increase above the pre-vaccination concentration one month after Dose 2 in subjects who were initially seropositive (antibody concentrations ≥ 15 mIU/mL for anti-HAV)."|One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
1284917|NCT00197002|Secondary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).|At one month after Dose 2 of Havrix® vaccine (Month 8-11)|The analysis was performed on the ATP Cohort for Immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284918|NCT00197002|Secondary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.|At one month after Dose 2 of Havrix® vaccine (Month 8-11)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
1284919|NCT00197002|Secondary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).|At one month after Dose 1 of Havrix® vaccine (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284920|NCT00197002|Secondary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.|At one month after Dose 1 of Havrix® vaccine (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
1284921|NCT00197002|Secondary|Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F|The immune response was defined, with respect to anti-pneumococcal response rates, as an antibody concentration equal to or above (≥) 0.05 μg/mL.|At one month after Prevnar™ vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
1285209|NCT00194792|Primary|Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation|Count of patients with dose reduction, treatment interruption, or treatment discontinuation.|During adjuvant and neoadjuvant chemotherapy||||Participants|||Count of Participants
1284923|NCT00197002|Primary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At one month after Dose 2 of Havrix® vaccine (Month 7-10)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
1284924|NCT00197002|Primary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.|At one month after Dose 2 of Havrix® vaccine (Month 7-10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
1284925|NCT00196976|Secondary|Number of Subjects With SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.|||Participants|||Count of Participants
1284926|NCT00196976|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the primary vaccination study (from Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1284927|NCT00196976|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after the booster vaccination|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.|||Participants|||Count of Participants
1284928|NCT00196976|Secondary|Number of Subjects With Any Unsolicited AEs During the Primary Vaccination|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1284929|NCT00196976|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after the primary meningococcal vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1284930|NCT00196976|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period following booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.|||Participants|||Count of Participants
1284931|NCT00196976|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period following booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.|||Participants|||Count of Participants
1284932|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.|||μg/mL||95% Confidence Interval|Geometric Mean
1284933|NCT00196976|Secondary|Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.|||Participants|||Count of Participants
1284934|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.|||Titers||95% Confidence Interval|Geometric Mean
1284935|NCT00196976|Secondary|Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups|A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.|||Participants|||Count of Participants
1284936|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||µg/mL||95% Confidence Interval|Geometric Mean
1284937|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|At one month (M1) and 12 months (M12) post primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Participants|||Count of Participants
1284938|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides|A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Participants|||Count of Participants
1284939|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Titers||95% Confidence Interval|Geometric Mean
1284940|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Serogroups|A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Participants|||Count of Participants
1284941|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Serogroups|A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Participants|||Count of Participants
1284942|NCT00196976|Secondary|Number of Children With Any Solicited General Symptoms|The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.|||Participants|||Count of Participants
1285051|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 204|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
1284943|NCT00196976|Secondary|Number of Toddlers With Any Solicited General Symptoms|The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.|||Participants|||Count of Participants
1284944|NCT00196976|Secondary|Number of Children With Any Solicited Local Symptoms|The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.|||Participants|||Count of Participants
1284945|NCT00196976|Secondary|Number of Toddlers With Any Solicited Local Symptoms|The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had filled in the symptom sheets.|||Participants|||Count of Participants
1284946|NCT00196976|Secondary|Antibody Concentrations Against Tetanus (Anti-T)|Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1284947|NCT00196976|Secondary|Number of Seropositive Subjects for Anti-tetanus (Anti-T)|A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1284948|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1284949|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1284950|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides|A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1284951|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1284952|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Serogroups|A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.|Prior to (Month 0) and one month after (Month 1) after the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1284953|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Serogroups|A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1284954|NCT00196976|Primary|Number of Subjects With an Immune Response to Different Meningococcal Serogroups|A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.|One month after the first vaccine dose (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1284955|NCT00196937|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSAEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.|During the entire study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort (for data up to Month 7) or on the Total vaccinated cohort of the extension follow-up phase (for the remaining data).|||subjects|||Number
1284956|NCT00196937|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort (for data up to Month 7) or on the Total vaccinated cohort of the extension follow-up phase (for the remaining data).|||subjects|||Number
1284957|NCT00196937|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day (Days 0-29) period following each vaccination||||subjects|||Number
1284958|NCT00196937|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on subjects with a documented dose.|||subjects|||Number
1284959|NCT00196937|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on subjects with a documented dose.|||subjects|||Number
1284960|NCT00196937|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After 2 Vaccine Doses and 6 Months Following the Complete Vaccination Course|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Seroconversion results at Month 7 (1 month after the complete vaccination course) are already presented above as primary outcome measure #1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and as secondary outcome measure #6 for Cervarix (46-55 Years) Group."|At Month 2 and Month 12|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity.|||subjects|||Number
1284961|NCT00196937|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Seroconversion results at Month 7 for the other 2 groups are already presented in the primary outcome measure #1."|At Month 7|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity with available data.|||subjects|||Number
1284962|NCT00196937|Secondary|Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion)|Seropositivity is defined as total IgG above or equal to 0 microgram per milliliter (µg/mL).|At Months 18 and 24|Analysis was performed on the Cervicovaginal samples subset cohort, including subjects for whom cervicovaginal secretion samples with less than 80 erythrocytes per milliliter were collected and results were available for Months 18 and/or 24.|||subjects|||Number
1284963|NCT00196937|Secondary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervical Samples|Titer given as GMT.|At Months 18 and 24|Analysis was performed on subjects from the Total vaccinated for whom cervical secretions results were available for Months 18 and/or 24.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1284964|NCT00196937|Primary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titer given as geometric mean titer (GMT).~Primary outcome measure assessed at Month 18, 24, 36, and 48."|Before vaccination (PRE) and at Months 2, 7, 12, 18, 24, 36 and 48|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data at the defined timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1284965|NCT00196937|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Seroconversion at Month 7 was a secondary outcome measure as per protocol for Cervarix (46-55 Years) Group."|At Month 7|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data for the Cervarix (46-55 Years) Group are presented in the Outcome #6.|||subjects|||Number
1285047|NCT00195715|Secondary|Percentage of Subjects Achieving Steroid-free CR-100|Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Subjects with corticosteroid use at baseline of preceding study, Observed Cases|||Percentage of participants|||Number
1284966|NCT00196716|Secondary|Urine Globotriaosylceramide (GL-3)|Evaluated at Baseline, Week 24 and Week 96. Urine GL-3 is often elevated in the urine of patients diagnosed with Fabry disease. This outcome measure evaluated the mean urine GL-3 in first morning void urine for all patients to see if it decreased while on Fabrazyme. Normal Urine GL-3 threshold was < 8.8 μg/mg.|Throughout study, 96 weeks|ITT population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||μg/mg||Standard Deviation|Mean
1284967|NCT00196716|Secondary|Plasma Globotriaosylceramide (GL-3)|Evaluated at Baseline, Week 24, Week 48, Week 72 and Week 96. Plasma GL-3 is often elevated in the plasma of patients diagnosed with Fabry disease. This outcome measure evaluated the mean plasma GL-3 values for all patients to see if it decreased while on Fabrazyme. Normal plasma GL-3 level was <= 7.03 µg/mL.|Throughout study; 96 weeks|ITT population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||μg/mL||Standard Deviation|Mean
1284968|NCT00196716|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Evaluated at Baseline, Week 24 and Week 96. eGFR is an estimation of the glomerular filtration rate of the kidneys (how much blood the kidneys are filtering). For this study, normal eGFR was defined as greater than 90 mL/min/1.73 m2|Throughout study; 96 weeks|ITT Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||ml/min/1.73 m2||Standard Deviation|Mean
1284969|NCT00196716|Secondary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 24, Week 48, Week 72, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Throughout study ; 96 weeks|ITT Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||Participants|||Number
1284970|NCT00196716|Primary|Globotriaosylceramide (GL-3) Clearance in Kidney Interstitial Capillary Endothelium|Kidney biopsies were taken at Baseline, Week 24, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Throughout study; 96 weeks|Intent-to-Treat (ITT) Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||Participants|||Number
1284971|NCT00196326|Primary|"Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy"|"Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.~The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication.~Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication.~Three denominators are reported;~excluding cycles where other birth control methods (BCMs) was used~all complete cycles~compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)"|up to one year|The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.|||pregnancies per 100 woman years exposure|||Number
1284972|NCT00196326|Secondary|Participants With Treatment-Emergent Adverse Events|Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.|Day 1 up to one year|The safety cohort consisted of all patient who took at least one dose of study medication|||participants|||Number
1284973|NCT00196326|Primary|"Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy"|"Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.~The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication.~Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication.~Three denominators are reported;~excluding cycles where other birth control methods (BCMs) was used~all complete cycles~compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)"|up to one year|The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.|||pregnancies per 100 woman years exposure|||Number
1284974|NCT00196313|Secondary|Analgesic Use|number of days analgesic (pain) medication was used over the 13 week treatment period|13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||Days Analgesic was used over 13 weeks||Standard Deviation|Mean
1284975|NCT00196313|Secondary|Number of Days Missed From School/Work or Other Activities||13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||Days||Standard Deviation|Mean
1284976|NCT00196313|Secondary|Incidence of Menstrual Bleeding and /or Spotting||Baseline to end of Week 13|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||Days of bleeding/spotting over 13 weeks||Standard Deviation|Mean
1284977|NCT00196313|Secondary|Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain|"Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13.~The severity of the pain was assessed using a 4-points scale (0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”)"|Baseline to end of Week 13|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||units on a scale||Standard Error|Least Squares Mean
1284978|NCT00196313|Primary|Mean Change in Average Severity for Abdominal/Pelvic Pain|Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”)|Baseline to end of 13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||units on a scale||Standard Error|Least Squares Mean
1284979|NCT00196196|Secondary|Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds|Percentage of agreement between consensus X-ray readings and the intended setting programmed by the Codman Valve Position Verification (VPV) system. This was assessed at various steps (intervals of mmH20) as increments allow on the Codman Hakim Programmable Valve. (1 step = 10 mmH20, 2 steps = 20 mmH20, +2 steps = >20 mmH20)|Day 1||||Percentage of agreement|||Number
1284980|NCT00196196|Primary|"Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading"|"Up to 5 attempts to achieve Adjustment Complete using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered consensus X-ray. All participants included achieved Adjustment Complete and a consensus X-ray reading."|Day 1||||Percentage of participants|||Number
1284981|NCT00196105|Primary|Time to Death|Overall Survival|up to 32 months||||Days||Inter-Quartile Range|Median
1284982|NCT00196105|Primary|Number of Deaths||up to 32 months||||Participants|||Number
1284983|NCT00196105|Primary|Number of Days to Occlusion||up to 32 months||||Days||Full Range|Median
1284984|NCT00196105|Primary|Closure or Blockage of the Stent (Occlusion)|"Biliary stents may become closed or blocked. This is also termed Occlusion. Data for this outcome measure involve stent occlusions that required re-intervention."|up to 32 months||||Stent Occlusions|||Number
1284985|NCT00196105|Primary|Patency|Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).|up to 32 months||||Days||Full Range|Median
1284986|NCT00195819|Primary|Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score|Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 [no change] to 72 [progression]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.|Baseline and Week 104|The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.|||score on a scale||Standard Error|Mean
1284987|NCT00195819|Secondary|Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure|The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.|Weeks 12 and 52|Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.|||score on a scale||Standard Error|Mean
1284988|NCT00195819|Secondary|Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure|The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.|Week 12 and Week 52|Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.|||score on a scale||Standard Error|Mean
1284989|NCT00195819|Secondary|Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage degradation and bone resorption were assessed by evaluating changes in NTx. A decrease in NTx represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||NM BCE||Standard Deviation|Mean
1285052|NCT00195715|Primary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, defined as all subjects who received at least 1 dose of study drug; Observed Cases|||Percentage of participants|||Number
1284990|NCT00195819|Secondary|Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage and bone degradation were assessed by evaluating changes in CTX-II. A decrease in CTX-II represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||ng/mmolcr||Standard Deviation|Mean
1284991|NCT00195819|Secondary|Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage and bone degradation were assessed by evaluating changes in MMP-3. A decrease in MMP-3 represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||ng/mL||Standard Deviation|Mean
1284992|NCT00195819|Secondary|Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure|"Completed by subject at each visit. The MCIS was a patient reported outcome where the subjects were expected to respond (yes/no) to the following question:~Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory? An increase in PASS indicates improvement.~During earlier weeks of the study PASS was measured/reported as minimal clinically important state (MCIS)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1284993|NCT00195819|Secondary|Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure|"ASQoL determined subject's quality of life comprised of 18 questions to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are subjects with MCID <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1284994|NCT00195819|Secondary|Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure|"ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1284995|NCT00195819|Secondary|Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure|Change from baseline in Health Utility Index Mark 3 (HUI-3) was reported. The HUI-3 is a generic approach to the measurement of health status and assessment of HRQL. The HUI-3 was comprised of two complementary components. The first component was a multi-attribute health status classification system that was used to describe health status. The second component was a multi-attribute utility function that was used to value health status as measured within the corresponding multi-attribute health status classification system. An increase in the HUI-3 score represents improvement.|Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
1284996|NCT00195819|Secondary|Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey completed by Subject, evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). Responders are subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285048|NCT00195715|Secondary|Percentage of Subjects Achieving Steroid-free Clinical Remission|Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Subjects with steroid use at baseline of preceding study, Observed Cases|||Percentage of participants|||Number
1284997|NCT00195819|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). Change from Baseline in the SF-36 Health Survey Index was completed by Subject. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
1284998|NCT00195819|Secondary|Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning)to 100 (highest level of functioning).~Responders were subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1284999|NCT00195819|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure|Change from Baseline in the SF-36 Health Survey Index completed by Subject to help subject keep track of how he/she was feeling and how well he/she was able to do usual activities. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicate improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
1285000|NCT00195819|Secondary|Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260|The FACIT-Fatigue scale: overall score of 13 general questions divided into four primary Quality of Life (QoL) domains: 1) Physical Well-Being, 2) Social/Family Well-Being, 3) Emotional Well-Being, and 4) Functional Well-Being. For each question subject rates his/her condition for the past week on a 5-point scale ranging from 0 (not at all) to 4 (very much). The score ranges from 0 (highest level of fatigue) to 52 with 52 being the lowest level of fatigue.|Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||unit on a scale||Standard Deviation|Mean
1285001|NCT00195819|Secondary|Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260|The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1285002|NCT00195819|Secondary|Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|The physician will globally assess the subject's current disease state using a VAS scale with 0 being very good and 100 being very bad.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1285003|NCT00195819|Secondary|Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure|"Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
1285004|NCT00195819|Secondary|Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260|"Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
1285005|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260|BAS-G consisted of two questions that asked the subject to indicate, on a 10 cm VAS, the effect the disease had on their well being over 1) last week, and 2) last 6 months. BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported. The mean of the two scores give a BAS-G score of 0-10.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1285006|NCT00195819|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||Units on a scale||Standard Deviation|Mean
1285007|NCT00195819|Secondary|Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260|"The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE.~An increase in chest expansion represents improvement"|Weeks 12, 24, 52,104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
1285008|NCT00195819|Secondary|Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260|The EDASMI is a composite spinal mobility index comprised of 4 measures: 1) cervical rotation, 2) lumbar side flexion, 3) chest expansion, and 4) hip internal rotation spread. A grade of 0-4 scoring system was developed for each of the measures. The sum of 4 items (range 0 to 16) provide the EDASMI score. Decrease in EDASMI represents improvement. All EDASMI measures were done with a simple tape measure and recorded in centimeters (cm) by a rheumatologist and a clinician nurse.|Weeks 12, 24, 52, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
1285009|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
1285010|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in BASDAI in subjects with adalimumab exposure from Baseline through 5 years for the effect of adalimumab on structural damage. Partial remission was calculated as follows: A value below 20 on a 0 - 100-point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function and Inflammation). Partial remission is also regarded as a low disease activity state.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285011|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260|"The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage.~ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP])."|Weeks 12, 16, 20, 24, 30, 36, 42, 48, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285181|NCT00195260|Secondary|Number of Participants With Change From Baseline in Opthalmologic Examination|Ophthalmologic evaluation included visual acuity, funduscopic examination, and any clinically-significant abnormality.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
1285012|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure|ASAS 40 responder: improvement of >= 40% and absolute improvement of >= 20 units (on a scale of 0 to 100) in >= 3 of the 4 domains: Patient global assessment (VAS score [0-100 scale]); Pain (Total Back Pain VAS score 0-100 scale); Function (BASFI score 0-100 scale); Inflammation (the mean of the two morning stiffness-related BASDAI VAS scores (i.e. the average of items 5 and 6 of the BASDAI. Applied to each scale. In addition, absence of deterioration in the potential remaining domain, where deterioration is defined as a net worsening of > 0 units (on a scale of 0 to 100).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244 and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285013|NCT00195819|Secondary|Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicate reduction in inflammation. A decrease in CRP indicates improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mg/dL||Standard Deviation|Mean
1285014|NCT00195819|Secondary|Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260|The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
1285015|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285016|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285017|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100(very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||Participants|||Number
1285018|NCT00195819|Secondary|Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure|A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe].|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||particpants|||Number
1285019|NCT00195819|Secondary|Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260|The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI) of 0 (none) to 10 (very severe). A decrease in inflammation represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
1285020|NCT00195819|Secondary|Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 128, 152, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285021|NCT00195819|Secondary|Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1285022|NCT00195819|Secondary|BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285023|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260|BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 10 cm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 10 (impossible).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1285024|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285025|NCT00195819|Secondary|Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1285026|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure|ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100[severe]) Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; 1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285049|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Response 70 (CR-70)|A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
1285027|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure|ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity; (0[none]-100[severe]) VAS scale; Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; (1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285028|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1285029|NCT00195819|Primary|Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BAth Ankylosing Spondylitis Functional Index (BASFI) VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Week 12|Full analysis set - includes all subjects who were randomized and received at least one injection of study medication. The full analysis set was analyzed by treatment group.|||participants|||Number
1285030|NCT00195715|Secondary|Percentage of Subjects With Fatal Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285031|NCT00195715|Secondary|Percentage of Subjects With Hematologic-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285032|NCT00195715|Secondary|Percentage of Subjects With Lupus-like Syndrome||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285033|NCT00195715|Secondary|Percentage of Subjects With Allergic Reaction-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285034|NCT00195715|Secondary|Percentage of Subjects With Hepatic-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285035|NCT00195715|Secondary|Percentage of Subjects With Demyelinating Disease||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285036|NCT00195715|Secondary|Percentage of Subjects With Congestive Heart Failure||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of subjects|||Number
1285037|NCT00195715|Secondary|Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285038|NCT00195715|Secondary|Percentage of Subjects With Injection Site Reaction-related Adverse Event|"An injection site reaction is any adverse event corresponding to a preferred term beginning with injection site excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration."|Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285039|NCT00195715|Secondary|Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285040|NCT00195715|Secondary|Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285041|NCT00195715|Secondary|Percentage of Subjects With Nonmelanoma Skin Cancer||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285042|NCT00195715|Secondary|Percentage of Subjects With Lymphoma||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285043|NCT00195715|Secondary|Percentage of Subjects With Malignancy||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285044|NCT00195715|Secondary|Percentage of Subjects With Serious Infection|Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.|Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
1285045|NCT00195715|Secondary|Percentage of Subjects With Infection||Up to 262 weeks of adalimumab treatment|Safety population, defined as all subjects who received at least 1 dose of study drug|||Percentage of participants|||Number
1285046|NCT00195715|Secondary|Percentage of Subjects With Fistula Remission|Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.|Week 156|Intent-to-treat, Subjects with fistulas present at baseline of the preceding study, Observed Cases|||Percentage of participants|||Number
1285053|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 108|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
1285054|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 48|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
1285055|NCT00195702|Other Pre-specified|Change From Baseline in Modified Total Sharp X-ray Score at Week 520|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 520|Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).|||units on a scale||Standard Deviation|Mean
1285056|NCT00195702|Other Pre-specified|Change From Baseline in Modified Total Sharp X-ray Score at Week 416|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 416|Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).|||units on a scale||Standard Deviation|Mean
1285057|NCT00195702|Other Pre-specified|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 520|Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).|||units on a scale||Standard Deviation|Mean
1285058|NCT00195702|Other Pre-specified|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 260|Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).|||units on a scale||Standard Deviation|Mean
1285059|NCT00195702|Other Pre-specified|Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520|The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).|||participants|||Number
1285060|NCT00195702|Other Pre-specified|Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260|The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.|Week 260|Participants analyzed were intent-to-treat with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).|||participants|||Number
1285061|NCT00195702|Other Pre-specified|Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10|Patients were responders if they had: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Baseline through Week 520|Participants analyzed were intent-to-treat subjects with non-missing response. Analyses were performed using data as observed (no imputation).|||participants|||Number
1285062|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).|||participants|||Number
1285063|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).|||participants|||Number
1285064|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).|||participants|||Number
1285065|NCT00195702|Other Pre-specified|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).|||participants|||Number
1285066|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (without imputation).|||participants|||Number
1285067|NCT00195702|Other Pre-specified|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed as observed (without imputation).|||Participants|||Number
1285068|NCT00195702|Other Pre-specified|Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)|Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.|Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group|Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.|||participants|||Number
1285069|NCT00195702|Other Pre-specified|Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)|Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.|Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group|Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.|||participants|||Number
1285070|NCT00195702|Secondary|Estimated Yearly Progression of Rheumatoid Arthritis|Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline.|||Units on a scale||Standard Deviation|Mean
1285109|NCT00195663|Secondary|Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component and items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Weeks 26 and 104|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
1285071|NCT00195702|Secondary|Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR70 response criteria for the first time at each time point is presented.|||Participants|||Number
1285072|NCT00195702|Secondary|Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR50 response criteria for the first time at each time point is presented.|||Participants|||Number
1285073|NCT00195702|Secondary|Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR20 response criteria for the first time at each time point is presented.|||Participants|||Number
1285074|NCT00195702|Secondary|Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.|||Participants|||Number
1285075|NCT00195702|Secondary|Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were ACR20 responders at Week 24 were evaluated to determine whether the response was maintained. Observed data were analyzed.|||Participants|||Number
1285076|NCT00195702|Secondary|Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a >= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were responders at Week 12 or 24 were evaluated to determine whether the response was maintained. LOCF data analysis was used for missing values.|||Participants|||Number
1285077|NCT00195702|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Last observation carried forward (LOCF) data analysis was used for missing values.|||Units on a scale||Standard Deviation|Mean
1285144|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Handling of ReFacto|Subjective assessment by the participant on handling (preparation and administration) of ReFacto. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
1285078|NCT00195702|Secondary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. LOCF data analysis was used for missing values.|||Units on a scale||Standard Deviation|Mean
1285079|NCT00195702|Secondary|Change From Baseline in Modified Total Sharp X-ray Score at Week 24|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 52.|||Units on a scale||Standard Deviation|Mean
1285080|NCT00195702|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 52|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.|||Participants|||Number
1285081|NCT00195702|Primary|Change From Baseline in Modified Total Sharp X-ray Score at Week 52|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 24 or early termination.|||Units on a scale||Standard Deviation|Mean
1285082|NCT00195702|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.|||Participants|||Number
1285083|NCT00195676|Other Pre-specified|Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|Participants in the Period R mITT population who did not relapse (did not have a PGA greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.|||percentage of participants|||Number
1285084|NCT00195676|Other Pre-specified|Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|Participants in the Period R mITT population who had relapsed (had a PGA of greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.|||percentage of participants|||Number
1285085|NCT00195676|Other Pre-specified|Time to Relapse in Period W|Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe).|Period W|Participants in the Period W Modified Intent-to-Treat Population who had relapsed (defined by a PGA of greater than or equal to 3) during Period W and had at least one post-baseline PGA assessment in Period W.|||days||95% Confidence Interval|Median
1285108|NCT00195663|Secondary|Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase|ACR-N is a composite, continuous variable which measures the percentage of improvement from Baseline in individual participants based on the 7 core set variables of the ACR. ACR-N is defined as the smallest percent change from Baseline of 3 measures: tender joint counts (TJC), swollen joint counts (SJC), and the median percent improvement in the 5 remaining measures (Patient's Assessment of Pain, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Health Assessment Questionnaire - Disability Index [HAQ-DI], and C-Reactive Protein). A positive ACR-N value indicates improvement; a negative ACR-N value indicates worsening; ACR-N of 0 indicates no change.|Baseline and Weeks 26, 52, 76, and 104|Full analysis set with available data.|||percent change||Standard Deviation|Mean
1285086|NCT00195676|Other Pre-specified|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120|Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.|Week 120|A subset of the the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.|||percentage of participants|||Number
1285087|NCT00195676|Other Pre-specified|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60|Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.|Week 60|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.|||percentage of participants|||Number
1285088|NCT00195676|Primary|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|The Period R Modified Intent-to-Treat population included 178 participants who relapsed and 107 participants who did not relapse in Period W when therapy was withdrawn; all received Period R adalimumab 40 mg every other week (after an 80 mg initial dose). Results were analyzed using non-responder imputation (NRI) for missing values.|||percentage of participants|||Number
1285089|NCT00195676|Other Pre-specified|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 120|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.|||percentage of participants|||Number
1285090|NCT00195676|Other Pre-specified|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 60|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.|||percentage of participants|||Number
1285091|NCT00195663|Secondary|Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A decrease in the HAQ-DI score represents an improvement in physical function; a clinically significant improvement is defined as a decrease of least 0.22 from Baseline in the HAQ-DI score. The number of participants with improvement in HAQ-DI of at least 0.22 and 0.5 units from Baseline is reported.|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing HAQ-DI scores at any post-baseline time point; N indicates patients with non-missing data at each specified time point."|||participants|||Number
1285092|NCT00195663|Secondary|Number of Participants With a Major Clinical Response Over 10 Years by Adalimumab Exposure|"A major clinical response was defined as maintenance of an ACR70 response for at least a 6-month continuous period at any time during the study following the first dose of adalimumab. A participant was a responder if the following criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein)."|From the first dose of adalimumab (at Week 1 or Week 106 for patients initially randomized to methotrexate in the DB phase) to Year 10|ITT Analysis Set for participants with non-missing ACR data.|||participants|||Number
1285093|NCT00195663|Secondary|Composite Score of ACR50 Plus No Change in Modified Total Sharp Score||Year 10|This outcome measure was not analyzed due to a protocol amendment.||||||
1285206|NCT00194896|Secondary|Patients Positive for T Cell Responses to Islet Proteins at 36 Months.|Number of participants positive for T cell reactivity to islet proteins at 36 months.|36 months||||participants|||Number
1285094|NCT00195663|Secondary|Number of Participants With No Radiographic Progression Over 10 Years|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement. The number of participants with change from Baseline ≤ 0.5 and ≤ 0 is reported as a measure of no disease progression.|Baseline (prior to first study drug treatment) and Years 2 and 10.|"ITT Analysis Set, with available data. N indicates patients with non-missing radiographic data at each time point."|||participants|||Number
1285095|NCT00195663|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) Over 10 Years|The modified TSS (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (prior to first study drug treatment) and Years 2 and 10|"ITT Analysis Set, with available data. N indicates patients with non-missing radiographic data at each time point."|||units on a scale||Standard Deviation|Mean
1285096|NCT00195663|Secondary|Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|After 1, 2, 5, and 10 years of adalimumab exposure|"ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing DAS28 scores at any post-baseline time point; N indicates patients with non-missing data at each specified time point."|||participants|||Number
1285097|NCT00195663|Secondary|Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. N indicates patients with non-missing data at Baseline and the specified time point."|||units on a scale||Standard Deviation|Mean
1285098|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. N indicates patients with non-missing data at each time point."|||units on a scale||Standard Deviation|Mean
1285099|NCT00195663|Secondary|Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"ITT Analysis Set with available data. N indicates patients with non-missing data at each time point."|||participants|||Number
1285106|NCT00195663|Secondary|Change From Baseline in Joint Erosion Score During the Double-blind Treatment Period|Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21–40% joint involvement; 3 = 3 separate quadrants with erosion or 41–60% joint involvement; 4 = all 4 quadrants with erosion or 61–80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion)to 230 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion.|Baseline and Weeks 52 and 104|Full analysis set. Missing values were imputed.|||units on a scale||Standard Deviation|Mean
1285100|NCT00195663|Secondary|Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"ITT Analysis Set with available ACR data. N indicates patients with non-missing data at each time point."|||participants|||Number
1285101|NCT00195663|Secondary|Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For participants randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"Intent-to-treat (ITT) Analysis Set (all patients who received at least 1 dose of adalimumab during the study, including patients who received their first dose during the DB phase and those who received MTX during the DB phase and adalimumab in the OL phase) with available ACR data. N indicates patients with non-missing data at each time point."|||participants|||Number
1285102|NCT00195663|Secondary|Number of Participants With Non-Involved Joints at Baseline and No Newly Involved Joints at Weeks 52 and 104|"Number of participants with non-involved joints at Baseline and no newly involved joints at Weeks 52 and 104, where involved joints or no newly involved joints are defined as modified Total Sharp Score (mTSS) = 0.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease])."|Baseline and Weeks 52 and 104|Full analysis set participants with non-involved joints at Baseline and non-missing data.|||participants|||Number
1285103|NCT00195663|Secondary|Number of Participants With No Erosions at Baseline and No New Erosions at Weeks 52 and 104|"The number of participants with no erosions at Baseline and no erosions at Weeks 52 and 104, where no erosions and no new erosions are defined as an erosion score = 0.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21–40% joint involvement; 3 = 3 separate quadrants with erosion or 41–60% joint involvement; 4 = all 4 quadrants with erosion or 61–80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 230 (worst)."|Baseline and Weeks 52 and 104|Full analysis set participants with no erosions at Baseline and non-missing data.|||participants|||Number
1285104|NCT00195663|Secondary|Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase|"The number of participants with no worsening in the modified Total Sharp Score (mTSS) and in erosion and joint space narrowing (JSN) scores, where no worsening is defined as a change from Baseline of ≤ 0 in mTSS, erosion score and JSN score, at Weeks 52 and 104.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement."|Baseline and Weeks 52 and 104|Full analysis set. Participants with missing data or who withdrew early were considered non-responders.|||participants|||Number
1285105|NCT00195663|Secondary|Change From Baseline in Joint Space Narrowing Score During the Double-blind Treatment Period|Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (16 joints) and each forefoot (5 joints) on a 5-point scale (0 = no narrowing; 1 = up to 25% narrowing; 2 = 26–65% narrowing; 3 = 66–99% narrowing; and 4 = complete narrowing). Scores were summed to calculate the total score ranging from 0 (no narrowing) to 168 (maximum narrowing). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.|Baseline and Weeks 52 and 104|Full analysis set. Missing values were imputed.|||units on a scale||Standard Deviation|Mean
1285107|NCT00195663|Secondary|Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
1285110|NCT00195663|Secondary|Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase|"The HUI 2/3 is an assessment of various aspects of participants’ health and ability to perform various tasks on a day-to-day basis, including reading, seeing, hearing, speaking, general outlook on life, pain/discomfort, ability to walk, use of hands, memory, ability to think/solve, and ability to perform basic activities such as eating, bathing, and dressing. The HUI 2/3 is a combined 15-item questionnaire based on a recall period of the previous 4 weeks. HUI-2 and HUI-3 scores are calculated independently. The HUI-2 score includes 6 attributes: Sensation, Mobility, Emotion, Cognition, Self-Care, and Pain. The HUI-3 score is comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition, and Pain.~The range of each score is from 0 (dead) to 1 (perfect health). An increase from Baseline indicates improvement."|Baseline and Weeks 26, 52, and 104|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
1285111|NCT00195663|Secondary|Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Missing values were considered to be < 0.3.|||participants|||Number
1285112|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Weeks 12, 26, 76, and 104|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
1285113|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Participants with insufficient data to calculate ACR70 or who withdrew early were considered non-responders.|||participants|||Number
1285114|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Participants with insufficient data to calculate ACR20 or who withdrew early were considered non-responders.|||participants|||Number
1285115|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Weeks 26 and 76|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26 and 76|Full analysis set. Participants with insufficient data to calculate ACR50 or who withdrew early were considered non-responders.|||participants|||Number
1285116|NCT00195663|Secondary|Change From Baseline in the Mental Component of the Short Form-36 Health Status Survey (SF-36) at Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Week 52|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
1285145|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Handling of ReFacto|Subjective assessment by the physician to evaluate the participants’ handling (preparation and administration) of ReFacto. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
1285117|NCT00195663|Secondary|Number of Participants With Major Clinical Response After 104 Weeks of Treatment|"Major clinical response was defined as an American College of Rheumatology 70% (ACR70) response for any six continuous months, over 104 weeks of treatment. A participant was a responder if the following criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were non-responders."|Any 6 continuous months from Baseline to Week 104|Full analysis set.|||participants|||Number
1285118|NCT00195663|Secondary|Change From Baseline in the Physical Component of the Short Form-36 Health Status Survey (SF-36) at Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Week 52|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
1285119|NCT00195663|Secondary|Number of Participants Who Achieved Clinical Remission, Defined as a Disease Activity 28 (DAS28) Score < 2.6 at Week 52|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Week 52|Full analysis set. Participants with insufficient data to calculate DAS28 at Week 52 or who withdrew early were considered non-responders.|||participants|||Number
1285120|NCT00195663|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 104|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 104 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 104|Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.|||units on a scale||Standard Deviation|Mean
1285121|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 104|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Week 104|Full analysis set. Participants with insufficient data to calculate ACR50 at Week 104 or who withdrew early were considered non-responders.|||participants|||Number
1285122|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Week 52|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
1285123|NCT00195663|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 52 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 52|Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.|||units on a scale||Standard Deviation|Mean
1285124|NCT00195663|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~Acute phase reactant value (C-Reactive Protein).~Participants who withdrew early were considered non-responders."|Baseline and 52 Weeks|The Full Analysis Set consisted of all patients who were randomized and who received at least one dose of double-blinded study medication. Participants with insufficient data to calculate ACR50 at Week 52 or who withdrew early were considered non-responders.|||participants|||Number
1285125|NCT00195650|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260|The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.|Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260|All participants who received at least 1 dose of open-label adalimumab (Full Analysis Set) in the continuation study and had a Week 260 visit. Analysis used observed data (no imputation).|||units on a scale||Standard Deviation|Mean
1285126|NCT00195650|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520|The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.|Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||units on a scale||Standard Deviation|Mean
1285127|NCT00195650|Primary|Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260|Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).|||participants|||Number
1285128|NCT00195650|Primary|Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520|Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||participants|||Number
1285129|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260|ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).|||participants|||Number
1285130|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520|ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||participants|||Number
1285131|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260|ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).|||participants|||Number
1285132|NCT00195650|Secondary|Reported Adverse Events|Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.|Duration of study (up to 520 weeks [10 years])|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set).|||participants|||Number
1285133|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520|ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||participants|||Number
1285134|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260|ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).|||participants|||Number
1285135|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520|ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||participants|||Number
1285136|NCT00195507|Secondary|Number of Patients With Survey Response of “Somewhat Satisfied” or Better|Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.|54 weeks|The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation.|||participants|||Number
1285137|NCT00195507|Secondary|Time to Achieve a Physician Global Assessment of Psoriasis Score of “Clear” or “Almost Clear”|Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.|54 weeks|The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug, had at least 1 post-baseline evaluation and who achieved a PGA status of 0 or 1 by the last visit (Observed cases).|||days||95% Confidence Interval|Median
1285138|NCT00195507|Secondary|Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline|Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.|54 weeks|The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).|||percentage improvement|||Number
1285139|NCT00195507|Primary|Physician Global Assessment of Psoriasis (PGA) Score – Mean Value Over 54 Weeks|Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).|54 weeks|The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).|||units on scale||Standard Deviation|Mean
1285140|NCT00195494|Secondary|Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death|Safety report for entire trial where participants reported a serious adverse event that led to death.|12 and 24 months|The analysis population is the modified intent to treat for year 1 (542 overall baseline participants) and year 2 (411 overall baseline participants).|||participants|||Number
1285141|NCT00195494|Primary|Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.|The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.|12 months|The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.|||participants|||Number
1285142|NCT00195494|Primary|The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.|Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.|12 months|The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.|||participants|||Number
1285143|NCT00195442|Secondary|Number of Participants for Days of Sick Leave Per Month|Days of sick leave (missing work or school) per month categorized as No days of absence, Number of days of absence, Long-term inability to work or study, Not employed or at school, or No specification.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
1285207|NCT00194896|Primary|Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.|Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.|36 months|Analysis per protocol|||ng per ml||Standard Deviation|Mean
1285146|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Tolerance|Subjective assessment by the participant to evaluate tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
1285147|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Tolerance|Subjective assessment by the physician to evaluate the participants’ tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
1285148|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Efficacy|Subjective assessment by the participant to evaluate control of bleeding. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
1285149|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Efficacy|Subjective assessment by the physician to evaluate control of bleeding. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
1285150|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success|Subjective assessment by the physician to evaluate treatment success (i.e., control of bleeding, Factor VIII consumption, treatment efficacy and tolerance, handling of preparation, and days missing from work or school). Physician rated assessment could be categorized as Very satisfied, Satisfied, Unsatisfied, or Very unsatisfied; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
1285151|NCT00195442|Secondary|Mean Annual ReFacto Consumption Per Patient Year|ReFacto administered as International Units (IU) according to the physician's decision following the drug's summary of product characteristics (SPC) and according to usual care principles.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.|||International units per year||Standard Deviation|Mean
1285152|NCT00195442|Secondary|Number of Participants With de Novo Inhibitor Formation|The applied criteria of clinical relevance for de novo inhibitor formation was defined as normal Factor VIII dosage was ineffective to control a bleeding, control of bleeding episodes required increasing Factor VIII dosage, change of concentrate type (administration of activated Prothrombin-Complex Concentrate [aPCC] or recombinant Factor VII [rFVII ]) was needed to stop a bleeding, or change of therapy strategy (intensive prophylaxis or Immune Tolerance Induction [ITI]) was required.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit.|||participants|||Number
1285153|NCT00195442|Secondary|Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any undesired side effect which occurred in a participant undergoing study treatment independent of whether a correlation with study treatment was suspected or not. SAEs are undesired events which were lethal or life-threatening, made hospitalization or extension of hospital stay necessary, lead to permanent damage with handicap (inability to work), as well as congenital anomalies, malignant disease, or overdosing. Also presence of inhibitors, thrombotic events, erythrocyte agglutination, allergic reactions, less than therapeutic effect, and inhibitor development were considered SAEs.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit; (n)=number of participants with events.|||events|||Number
1285154|NCT00195442|Primary|Mean Number of Exposure Days Per Patient Year|Exposure days are the number of days of treatment with ReFacto.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.|||days per year||Standard Deviation|Mean
1285155|NCT00195442|Primary|Mean Number of Bleeding-related Exposure Days Per Patient Year|Exposure days are the number of days of treatment with ReFacto.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.|||days per year||Standard Deviation|Mean
1285156|NCT00195442|Primary|Mean Number of Bleeding Episodes Per Patient Year|Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.|||episodes per year||Standard Deviation|Mean
1285157|NCT00195429|Secondary|Creatinine Clearance Rate|Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|12 months|The population that was used for this analysis was patients who completed 12 months.|||ml/min||Standard Deviation|Mean
1285208|NCT00194792|Secondary|Correlation of Molecular Markers With Response, Time to Progression, and Survival||Weekly during CHB and XMN and pacitaxel|Molecular marker data was not collected for this cohort and thus not possible to report results for this outcome.||||||
1285158|NCT00195429|Primary|Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.|Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).|12 months|The population that was used for this analysis was the transplantation recipient population, which included all randomized patients.|||participants|||Number
1285159|NCT00195403|Secondary|Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9|Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Month 3, 9|Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration. 'N' (number of participants analyzed) = participants who were evaluable for this measure. Data for Month 9 was not analyzed because there were not enough participants for analysis.|||joints||Standard Deviation|Mean
1285160|NCT00195403|Primary|Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3|PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible.|Baseline, Month 3|Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration.|||cm||Standard Deviation|Mean
1285161|NCT00195403|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.|Baseline up to Day 832|Safety population included all participants who received >= 1 dose of study medication and had the safety assessment through appropriate follow-up.|||participants|||Number
1285162|NCT00195351|Secondary|Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.|Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline & response was failure.|10-21 days after the last dose of test article|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.|||participants|||Number
1285163|NCT00195351|Secondary|Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.|The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|10-21 days after the last dose of test article|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.|||participants|||Number
1285164|NCT00195351|Primary|Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.|The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|10-21 days after the last dose of test article|All patients who received ≥1 dose of study drug, who had clinical evidence of complicated intra-abdominal infection, met all inclusion and exclusion criteria, and completed TOC assessment within 8-44 days after last dose of study drug. Patients with an indeterminate assessment were excluded.|||participants|||Number
1285165|NCT00195338|Secondary|Mean Dose of Concomitant Methotrexate (MTX) and Steroids||Baseline up to Month 66|Data was not analyzed due to low number of participants.|||milligram (mg)||Standard Deviation|Mean
1285166|NCT00195338|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty = 0), 'adequate' (some difficulty = 1), 'limited' (much difficulty = 2), and 'unable to do' (= 3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total possible score ranged from 0 (no difficulty) to 60 (unable to do).|Baseline, Months 6, 12, 18, 30, 42, 54 and 66|FAS included all recruited participants who were either initiated or were already receiving etanercept. 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1285167|NCT00195338|Secondary|Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66|Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac.|Baseline, Months 6, 12, 18, 30, 42, 54 and 66|FAS included all recruited participants who were either initiated or were already receiving etanercept. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.|||joints||Standard Deviation|Mean
1285168|NCT00195338|Secondary|Percentage of Participants With Completion of Study Treatment||Month 12 through Month 72|FAS included all recruited participants who were either initiated or were already receiving etanercept.|||percentage of participants|||Number
1285169|NCT00195338|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 66|Full analysis set (FAS) included all recruited participants who were either initiated or were already receiving etanercept.|||percentage of participants|||Number
1285170|NCT00195273|Secondary|Mean Creatinine Clearance Rate - 3 Months|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.|3 months|All patients who completed 3 months of study drug.|||ml/min||Standard Deviation|Mean
1285171|NCT00195273|Secondary|Patient and Graft Survival|Graft survival is measured by graft loss which is defined as removal of the transplant.|12 months|All patients who received at least one dose of study drug.|||patients|||Number
1285172|NCT00195273|Secondary|Number of Patients With Acute Rejection|The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy.|3 and 12 months|All patients who received at least one dose of study drug.|||patients|||Number
1285173|NCT00195273|Primary|Mean Creatinine Clearance Rate|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.|12 months|All patients who completed 12 months of study drug.|||ml/min||Standard Deviation|Mean
1285174|NCT00195260|Other Pre-specified|Gene Expression at Baseline|Gene expression profile was evaluated by measuring transcript levels of messenger RNA (mRNA) in peripheral blood samples. Expression profiling of mRNA: done to measure the expressed genome of mRNA transcripts or done in a gene-specific targeted manner.|Baseline|Data was not analyzed as the analysis was cancelled due to lack of samples provided from sites.||||||
1285175|NCT00195260|Secondary|Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Steady state concentration was achieved at Day 15.|0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.|||ng*hour/mL||Standard Deviation|Mean
1285176|NCT00195260|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.|||hours||Standard Deviation|Mean
1285177|NCT00195260|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.|||hours||Full Range|Median
1285178|NCT00195260|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1285179|NCT00195260|Secondary|Progression Free Survival (PFS) in Part 2|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD, or from death CRFs).|Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.|||weeks||95% Confidence Interval|Median
1285180|NCT00195260|Secondary|Overall Survival (OS) in Part 2|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from death case report forms (CRFs) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.|||weeks||95% Confidence Interval|Median
1285210|NCT00194792|Primary|Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities|Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities|Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)||||events|||Number
1285182|NCT00195260|Secondary|Number of Participants With Change From Baseline in Physical Examination|Physical examinations included body weight, height and vital signs and only finding that exceeded the criterion for PCS was weight. Criteria for weight was: an increase or decrease of >=10% from baseline.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure for each group respectively.|||participants|||Number
1285183|NCT00195260|Secondary|Change From Baseline in Karnofsky Performance Score|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (complete healthy status). Higher score means higher ability to perform daily tasks.|Baseline up to end of treatment (Week 95)|Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.||||||
1285184|NCT00195260|Secondary|Concomitant Medications Used for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Day 1 up to end of treatment (Week 95) as a management of an AE was to be reported.|Day 1 up to end of treatment (Week 95)|Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.||||||
1285185|NCT00195260|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG) and Chest X-ray|Number of participants with PCS ECG findings is reported on-therapy (OT) and at final visit (FV). Criteria for PCS ECG findings: heart rate (HR) =<45 beats/minute (bpm) and decrease (Dec) >15/>=120 bpm and decrease of >15 bpm; PR interval (Int) >=220 millisecond (msec), increase (Inc) >=20 msec, QRS Int >=120 msec, corrected QT (QTc) and QTc using fridericia formula(QTcF) Int >500 msec, increase >60 msec; no sinus rhythm; overall ECG abnormal. Participants with at least 1 measurement exceeding the criteria for PCS are reported.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure and 'n' represents participants evaluable under each category for each group respectively.|||participants|||Number
1285186|NCT00195260|Secondary|Number of Participants With Change From Baseline in Laboratory Test Results|Criteria for potentially clinically significant (PCS) laboratory values: albumin <20, hemoglobin <80 gram/liter(g/L); alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); bilirubin total, creatinine>3*ULN micromole/L; calcium <1.75 and >3.1,potassium <3 and >6, sodium <130, glucose <2.2,phosphorous <0.6 millimole/L; international normalized ratio >2*ULN, partial thromboplastin time, prothrombin time >2*ULN seconds; platelet count <50*10^9/L. Participants meeting at least 1 PCS criteria are reported.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy laboratory assessment) for this measure for each group respectively.|||participants|||Number
1285187|NCT00195260|Secondary|Maximum Tolerated Dose (MTD) for Prolonged Use|MTD for prolonged use was the highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1) and was selected as recommended dose in Phase 2, due to substantial number of Grade 2 gastrointestinal toxicities observed in the MTD lead-in cohort (500 mg).|Part 1 Day 1 up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.|||mg|||Number
1285188|NCT00195260|Primary|Maximum Tolerated Dose (MTD) in Part 1|MTD: highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.|Part 1 Day 1 up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.|||mg|||Number
1285189|NCT00195260|Primary|Number of Participants With Best Overall Response (BOR) in Part 2|BOR: investigator assessment by modified RECIST, recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. PR: >=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Part 2 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.|||participants|||Number
1285190|NCT00195260|Primary|Number of Participants With Best Overall Response (BOR) in Part 1|BOR:investigator assessment by modified Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response:disappearance of all lesions. Partial Response (PR):>=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Part 1 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.|||participants|||Number
1288801|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg|72-hour fasting Day 3 Leptin dose 0.1 mg/kg|3 DAY||||NG/ML||Standard Deviation|Mean
1285191|NCT00195260|Primary|Duration of Most Frequently Observed Adverse Events (AEs)|The most frequently observed treatment-emergent AEs were gastrointestinal disorders which included diarrhea, nausea and vomiting. Duration of AE per event is calculated as AE stop date minus AE start date plus 1.|Baseline up to 30 days after last dose|Safety population included all participants who had taken at least 1 dose of study medication.|||days||Full Range|Median
1285192|NCT00195260|Primary|Number of Participants With Adverse Events (AEs) by Seriousness|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 30 days after last dose|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
1285193|NCT00195260|Primary|Number of Participants With Dose-limiting Toxicities (DLT) in Part 1|DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to less than or equal to [=<] grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.|Part 1 Baseline up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.|||participants|||Number
1285194|NCT00195039|Secondary|Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.||Scans will be performed between day 6 and 8.||||Participants|||Count of Participants
1285195|NCT00195039|Secondary|Assess the Survival Rate of Patients Following Treatment.||From baseline through study completion||||months||95% Confidence Interval|Median
1285196|NCT00195039|Secondary|Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).|Bone scan score determined for each patient and related to the degree of hematological toxicity quantified by % decline of nadir platelet count relative to baseline count.|Bone scan will be performed at baseline and Day 85.||||participants|||Number
1285197|NCT00195039|Secondary|Define the Incidence of Human Anti-J591 Antibody (HAHA) Response.||HAHA samples will be drawn at baseline and Day 85.|Samples were collected but data necessary to summarize this outcome measure was not collected because the study team felt that there was adequate data from previous phase I studies, including repeating dosing of the study drug in this study and others that were performed prior to this study’s completion.||||||
1285198|NCT00195039|Secondary|Define the Toxicity of 177Lu-J591 Given as Single Dose.|"Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL*.~Grade 3 Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**.~Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."|From baseline until end of treatment phase (12 weeks)||||Participants|||Count of Participants
1285199|NCT00195039|Secondary|Define the Duration of Biochemical PSA and/or Measurable Disease Response.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Complete Response (CR) = Disappearance of all target lesions, Partial Response (PR) = A </=30% decrease in the sum of the longest diameter of target lesions, taking as reference the Baseline sum longest diameter, Stable Disease (SD) = Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, Progressive Disease (PD) = A >/=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions|At baseline, and up to death||||months||95% Confidence Interval|Median
1285200|NCT00195039|Primary|Define the Measurable Disease Response Rate.|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study"|Disease will be assessed at baseline and day 85.|Only 12 patients had measurable disease|||Participants|||Count of Participants
1285201|NCT00195039|Primary|Define the PSA Response Rate.|PSA response rate corresponds to change form baseline in PSA at any of the time points specified.|At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks||||Participants|||Count of Participants
1285202|NCT00195013|Primary|Change in Peripheral Neuropathy Score|"Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result).~Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity."|Duration of study, approximately 10 weeks per subject||||Change in Total Neuropathy Score||Full Range|Mean
1285203|NCT00194987|Secondary|Number of Fetal Platelet Counts > 50,000/uL|Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined|32 +/- 2 weeks||||number newborns with >50,000 pats|||Number
1285204|NCT00194987|Secondary|Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study|number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation|time of ICH (range 20-40 wks)||||number of newborns with ICH|||Number
1285205|NCT00194987|Primary|Number of Newborns With a Birth Platelet Count > 50,000/uL|this uses the birth platelet count of the fetuses from the study when they are born|32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40||||number of newborns with >50,000 pets|||Number
1285213|NCT00194792|Primary|Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response|Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.|From date of treatment start to surgery||||Participants|||Count of Participants
1285214|NCT00194792|Primary|Number of Participants With Clinical Response|Defined as a > 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.|1 month||||Participants|||Count of Participants
1285215|NCT00194779|Secondary|Clinical Response to Paclitaxel||Up to 24 weeks||||Participants|||Count of Participants
1285216|NCT00194779|Secondary|Clinical Response to Neoadjuvant Therapy||Up to 12 weeks||||Participants|||Count of Participants
1285217|NCT00194779|Secondary|Disease-free Survival|Kaplan-Meier estimate of disease-free survival, assessed at 1, 2, and 5 years.|1, 2, and 5 years||||disease-free survival probability||95% Confidence Interval|Number
1285218|NCT00194779|Secondary|OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN|Kaplan-Meier estimate of overall survival, assessed at 1, 2, and 5 years.|1, 2, and 5 years||||survival probability||95% Confidence Interval|Number
1285219|NCT00194779|Secondary|Time to Progression|Median time to progression free survival.|Up to 5 years||||months||95% Confidence Interval|Median
1285220|NCT00194779|Secondary|Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy|Count of patients that relapsed.|Up to 8 years||||Participants|||Count of Participants
1285221|NCT00194779|Secondary|Correlation of Molecular Markers With Response||After completion of neoadjuvant therapy|Due to lack of funding, none of the tissue specimens from participants were tested for EGFR, AR, P53 and Topo2alpha expression, as originally intended by the protocol.||||||
1285222|NCT00194779|Secondary|Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation||From the initiation of study treatments to 30 days after the end of neoadjuvant treatment or adjuvant treatment if received||||Participants|||Count of Participants
1285223|NCT00194779|Primary|Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)|"Microscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer >= 1 cm.~Count of participants with either a pCR or mCR."|Up to 16 weeks||||Participants|||Count of Participants
1285224|NCT00194675|Secondary|Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.||Baseline, 3-months, 6-months|per protocol|||ng/ dL||Standard Deviation|Mean
1285225|NCT00194675|Secondary|Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume||Baseline, 3-months, 6-months||||cc||Standard Deviation|Mean
1285226|NCT00194675|Secondary|Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)||Baseline, 3-months, 6-months|per protocol|||cc/sec||Standard Deviation|Mean
1285227|NCT00194675|Secondary|The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)|International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales.|Baseline, Month 3, Month 6|per protocol|||score||Standard Deviation|Mean
1285228|NCT00194675|Secondary|Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)||Baseline, Month 6|per protocol|||ng/ ml||Standard Deviation|Mean
1285229|NCT00194675|Primary|Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.||Baseline, Month 6|per protocol|||cubic centimeters||Standard Deviation|Mean
1285230|NCT00194610|Primary|Chronic Prostatitis Symptom Index (CPSI-F)|CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.|3 months|Total number of subjects was based on clinical volume, and subjects were randomized into each of two arms.|||Total CPSI-F||Standard Deviation|Mean
1285231|NCT00194532|Secondary|Microbiologic Cure|Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up|1-15 days post therapy|Per protocol. Participants were eligible for analysis if they had an enrollment urine containing uropathogens and a urine specimen taken at follow-up.|||participants|||Number
1285232|NCT00194532|Primary|Clinical Cure|Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin|28-30 days post therapy|modified ITT|||participants|||Number
1285233|NCT00194129|Secondary|Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex|Number of subjects who no longer met criteria for active cocaine abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex|Baseline to Month 6|This only includes subjects who were using cocaine at the time of study entry. The purpose of this analysis was to see if treatment with both open-label lithium & divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of cocaine use disorders.|||Participants|||Count of Participants
1285323|NCT00192296|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Hours||Full Range|Median
1285234|NCT00194129|Secondary|Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex|Number of subjects who no longer met criteria for active cannabis abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex|Baseline to Month 6|This only includes subjects who had a cannabis use disorder at study entry. The purpose of this analysis was to see if treatment with both open-label lithium and divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of cannabis use disorders.|||Participants|||Count of Participants
1285235|NCT00194129|Secondary|Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex|Number of subjects who no longer met criteria for active abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex|Baseline to Month 6|This only includes subjects who had an alcohol use disorder at study entry. The purpose of this analysis was to see if treatment with both open-label lithium and divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of alcohol use disorders.|||Participants|||Count of Participants
1285236|NCT00194129|Secondary|Time to Treatment for Emerging Symptoms of a Depressive Episode||Up to 6 months|Due to the heavily censored nature of this data, the median survival for time to treatment for emerging depression symptoms in both arms is not evaluable. Statistics software was unable to analyze the data.||||||
1285237|NCT00194129|Secondary|Time to Treatment for Emerging Symptoms of a Manic/Hypomanic/Mixed Episode||Up to 6 months|Due to the heavily censored nature of this data, the median survival for time to treatment for emerging manic/hypomanic/mixed symptoms in both arms is not evaluable. Statistics software was unable to analyze the data.||||||
1285238|NCT00194129|Primary|Time to Treatment for Emerging Symptoms of a Mood Relapse|A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.|Up to 6 months||||weeks||95% Confidence Interval|Median
1285239|NCT00194077|Primary|Time in Weeks to Discontinuation|Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.|up to 72 weeks||||time in weeks to discontinuation||95% Confidence Interval|Mean
1285240|NCT00194025|Secondary|Tolerability as Measured by Mean Serum Level at Study Endpoint||Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||ug/mL||Standard Deviation|Mean
1285241|NCT00194025|Secondary|Tolerability as Assessed by Weight Change||Baseline to 12 weeks|All available data was used implementing LOCF.|||kilograms||Standard Deviation|Mean
1285242|NCT00194025|Secondary|Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)|The best and worst possible overall scores are 40 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
1285243|NCT00194025|Secondary|Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)|The best and worst possible overall scores are 0 and 28 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
1285244|NCT00194025|Secondary|Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)|The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
1285245|NCT00194025|Secondary|Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)|The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.|Baseline to 12 weeks|The number of participants for analysis was based on available data. Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
1285246|NCT00194025|Secondary|Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)|The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
1285247|NCT00194025|Secondary|Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)|The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
1285248|NCT00194025|Secondary|Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)|The best and worst possible overall scores are 31 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
1285249|NCT00194025|Primary|Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)|The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
1285250|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 17 of those 21 completed the ARS-IV and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
1285324|NCT00192296|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants who had ADA detected at each time point|Days 14, 28, 42, and 84|All subjects who received MEDI-528|||Participants|||Number
1285251|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||units on a scale||Standard Deviation|Mean
1285252|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||units on a scale||Standard Deviation|Mean
1285253|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CGI-S and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
1285254|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||units on a scale||Standard Deviation|Mean
1285255|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||units on a scale||Standard Deviation|Mean
1285256|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis."|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 19 of those 22 and 18 of those 21 completed the CGAS and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
1285257|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis."|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1285258|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis."|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1285259|NCT00194012|Secondary|CDRS-R Children's Depression Rating Scale-Revised|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CDRS-R and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
1285260|NCT00194012|Secondary|CDRS-R Children's Depression Rating Scale-Revised|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1285261|NCT00194012|Secondary|Children's Depression Rating Scale-Revised (CDRS-R )|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1285262|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the YMRS and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
1285263|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|12 weeks||||Scores on a scale||Standard Deviation|Mean
1285264|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|Baseline||||Scores on a scale||Standard Deviation|Mean
1285265|NCT00193609|Secondary|Overall Survival|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|18 months||||months||95% Confidence Interval|Median
1285266|NCT00193609|Primary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|18 months||||months||95% Confidence Interval|Median
1285267|NCT00193596|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|12 months||||months||95% Confidence Interval|Median
1285268|NCT00193596|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|24 months||||months||95% Confidence Interval|Median
1285322|NCT00192296|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1285269|NCT00193492|Secondary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death or Disease Progression from NHL. Progression is defined using International Workshop Response Criteria for Non-Hodgkin’s Lymphoma as - enlargment of liver/spleen, new sites, new or increased malignancy in lymph nodes, new or increased lymph node masses or reappearance of disease in bone marrow.|18 months||||months||95% Confidence Interval|Median
1285270|NCT00193492|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months||||percentage of participants||95% Confidence Interval|Number
1285271|NCT00193479|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 Months||||percentage of patients|||Number
1285272|NCT00193453|Secondary|Response Duration|The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.|18 months|Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.|||Months||95% Confidence Interval|Median
1285273|NCT00193453|Secondary|Progression Free Survival (PFS)|Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.|18 months|All patients were assessed for progression-free survival.|||Months||95% Confidence Interval|Median
1285274|NCT00193453|Primary|Overall Clinical Response Rate|Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.|18 months|Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1285275|NCT00193427|Secondary|Overall Survival (OS)|Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.|18 months|All patients were assessed for overall survival after a median follow-up of 19 months.|||Months||95% Confidence Interval|Median
1285276|NCT00193427|Secondary|Overall Response Rate (ORR)|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 months|Patients who were assessable after completion of 9 weeks of treatment were evaluated and assigned a response category.|||Percent of patients with CR or PR|||Number
1285277|NCT00193427|Secondary|Progression Free Survival (PFS)|Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.|19 months|All patients were assessed for progression free survival after a median follow up of 19 months.|||Months||95% Confidence Interval|Median
1285278|NCT00193427|Primary|Pathologic Complete Response Rate|A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.|18 months|All patients who underwent a thoracotomy were assigned a pathologic response category.|||Percent of participants with pCR|||Number
1285279|NCT00193414|Secondary|Overall Survival (OS)|OS was measured from the date of study entry until the date of death.|18 months|All patients were assessed for OS.|||Months||95% Confidence Interval|Median
1285280|NCT00193414|Secondary|Progression-free Survival (PFS)|PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.|18 months|All patients were assessed for PFS.|||Months||95% Confidence Interval|Median
1285281|NCT00193414|Primary|Overall Response Rate|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 months|All patients were assessed for response.|||Percentage of participants with CR/PR||95% Confidence Interval|Number
1285282|NCT00193375|Primary|Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)|Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.|18 months|Patients who received at least one dose of bevacizumab maintenance therapy were assessed for toxicities.|||Grade 3/4 Toxicity Events|||Number
1285283|NCT00193375|Secondary|Overall Response Rate|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 month|All patients were evaluated for response by RECIST v. 1 criteria. All patients with major responses had confirmation of response on repeat scans by the same technique(s) 4 weeks (or longer) later.|||percentage of participants||95% Confidence Interval|Number
1285284|NCT00193375|Secondary|2-Year Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.|24 months|All patients were assessed for progression free survival.|||percentage of participants|||Number
1285285|NCT00193258|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||24 months|All patients enrolled in the study|||months||95% Confidence Interval|Median
1285287|NCT00193258|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Eighty-seven of 94 patients (93%) received ≥ 2 months of treatment and were fully evaluable for response. Seven patients discontinued treatment during the first 8 weeks. One of these 7 patients had evidence of rapid tumor progression, whereas the remaining 6 patients discontinued treatment because of toxicity or for personal reasons.|||percentage of participants||95% Confidence Interval|Number
1285288|NCT00193219|Secondary|Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab||18 months|||||||
1285289|NCT00193219|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Measured from the date of first treatment until the date of death from any cause|36 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.|||months||95% Confidence Interval|Median
1285290|NCT00193219|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.|18 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.|||months||95% Confidence Interval|Median
1285291|NCT00193219|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.|||percentage of patients||95% Confidence Interval|Number
1285292|NCT00193206|Secondary|Rates of Breast Preservation||18 months|||||||
1285293|NCT00193206|Secondary|Time to Disease Progression||18 months|||||||
1285294|NCT00193206|Secondary|Clinical Response Rates||18 months|||||||
1285295|NCT00193206|Primary|Pathologic Complete Response||18 months||||participants|||Number
1285296|NCT00193180|Secondary|Overall Survival (OS)|Defined as the time from first protocol treatment to date of death due to any cause.|18 months||||months||95% Confidence Interval|Median
1285297|NCT00193180|Secondary|Progression Free Survival (PFS)|PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|18 months||||Months||95% Confidence Interval|Median
1285298|NCT00193180|Primary|Overall Response Rate (ORR)|Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.|18 months||||percentage of participants||95% Confidence Interval|Number
1285299|NCT00193128|Secondary|Overall Survival (OS)|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|36 months|||||||
1285300|NCT00193128|Secondary|Disease-Free Survival (DFS)|Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.|18 months|||||||
1285301|NCT00193128|Primary|Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery|The absence of any residual tumor cells in a histologic evaluation of a tumor specimen is defined as a complete pathologic response|18 months|Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy|||percentage of participants|||Number
1285302|NCT00193063|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|24 months||||months||95% Confidence Interval|Median
1285303|NCT00193063|Secondary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|21 Months||||months||95% Confidence Interval|Median
1285304|NCT00193063|Primary|Overall Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 Months||||percentage of participants||95% Confidence Interval|Number
1285305|NCT00193050|Secondary|Overall Survival (OS)||48 months|||||||
1285306|NCT00193050|Secondary|Time to Treatment Failure (TTF)||69 months|||||||
1285307|NCT00193050|Primary|Pathologic Complete Response (pCR)||18 Months||||percentage of participants||95% Confidence Interval|Number
1285308|NCT00193037|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.|PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.|18 Months||||months||95% Confidence Interval|Median
1285325|NCT00192296|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 84|All subjects who received MEDI-528|||Participants|||Number
1285309|NCT00193037|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.|18 Months|Patients who were removed from treatment before evaluation were not included in analysis|||percentage of patients||95% Confidence Interval|Number
1285310|NCT00192647|Secondary|Change From Baseline in Log10 HCV RNA Values|The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.|Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)|ITT analysis population; Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.|||Log 10 IU/mL||Standard Deviation|Mean
1285311|NCT00192647|Secondary|Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response|The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.|Weeks 4, 12, and 72|ITT analysis population; participants who did not have an HCV RNA measurement at Week 4 or 12 and at Week 72 were excluded from the analysis. Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.|||percentage of participants|||Number
1285312|NCT00192647|Secondary|Percentage of Participants With Relapse of End-of-treatment Virological Response|Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.|Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)|ITT analysis population. Here, number of participants analyzed signifies participants who had end of treatment virologic response and had HCV RNA measurement available during follow-up.|||percentage of participants|||Number
1285313|NCT00192647|Secondary|Percentage of Participants With Virological Responses Over Time|Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.|Weeks 4, 8, 12, and 24|ITT analysis population|||percentage of participants|||Number
1285314|NCT00192647|Secondary|Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period|Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.|Weeks 48|ITT analysis population|||percentage of participants|||Number
1285315|NCT00192647|Primary|Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period|Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.|Week 72|ITT analysis population|||percentage of participants|||Number
1285316|NCT00192296|Secondary|Terminal Phase Elimination Rate (Vz)|Vz of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Liters||Geometric Coefficient of Variation|Geometric Mean
1285317|NCT00192296|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Hours||Geometric Coefficient of Variation|Geometric Mean
1285318|NCT00192296|Secondary|Total Body Clearance (CL)|CL of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Milliter per day||Geometric Coefficient of Variation|Geometric Mean
1285319|NCT00192296|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Percentage of Projected AUC||Geometric Coefficient of Variation|Geometric Mean
1285320|NCT00192296|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Microgram times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
1285321|NCT00192296|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Micrograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
1285326|NCT00192296|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)|Days 0, 7, 14, 21, and 28|All subjects who received MEDI-528|||Participants|||Number
1285328|NCT00192075|Other Pre-specified|Duration of Response - A+FOLFOX4 - Avastin Subgroup|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Results were not calculable for the A+FFG-Avastin subgroup. Two patients were censored in the A+FOLFOX4-Avastin subgroup.|||months||95% Confidence Interval|Median
1285329|NCT00192075|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population who were responders (had best overall response of either complete response or partial response). Zero patients in A+FFG and 2 patients in A+FOLFOX4 were censored.|||months||95% Confidence Interval|Median
1285330|NCT00192075|Other Pre-specified|Toxicity - Avastin Subgroup|Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events|every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.|||participants|||Number
1285331|NCT00192075|Other Pre-specified|Survival at 12 Months and 24 Months - Avastin Subgroup|Percentage of participants who were alive at 12 months and 24 months.|randomization to the date of death from any cause (up to 24 months)|The original treatment regimens were FFG (Arm A) and FOLFOX (Arm B). Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.|||percentage of participants alive||95% Confidence Interval|Number
1285332|NCT00192075|Other Pre-specified|Progression-Free Survival - Avastin Subgroup|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 3 patients in A+FOLFOX4 - Avastin subgroup were censored.|||months||95% Confidence Interval|Median
1285333|NCT00192075|Other Pre-specified|Time to Progressive Disease - Avastin Subgroup|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 4 patients in A+FOLFOX4 - Avastin subgroup were censored.|||months||95% Confidence Interval|Median
1285334|NCT00192075|Other Pre-specified|Tumor Response - Avastin Subgroup|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.|||participants|||Number
1285335|NCT00192075|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Eight patients in A+FFG and 12 patients in A+FOLFOX4 were censored.|||months||95% Confidence Interval|Median
1285336|NCT00192075|Secondary|Progression-Free Survival|Defined as the time from randomization to the first observation of disease progression, or death due to any cause.|randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Three patients in A+FFG and 4 patients in A+FOLFOX4 were censored.|||months||95% Confidence Interval|Median
1285337|NCT00192075|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Five patients in A+FFG and 5 patients in A+FOLFOX4 were censored.|||months||95% Confidence Interval|Median
1285338|NCT00192075|Primary|Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent-to-Treat Population|||participants|||Number
1285339|NCT00192036|Secondary|Safety of Chemo-radiotherapy|A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening.|Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy|All enrolled participants receiving chemo-radiotherapy (Cycle 4).|||participants|||Number
1285340|NCT00192036|Secondary|Safety of Induction Chemotherapy|A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.|every cycle (21 days) for 3 cycles (up to 10 weeks)|All enrolled participants.|||participants|||Number
1285341|NCT00192036|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)|All enrolled participants.|||months||Full Range|Median
1285342|NCT00192036|Secondary|Time to Progressive Disease|Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.|Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);|All enrolled participants.|||months||Full Range|Median
1285343|NCT00192036|Primary|Tumor Response at End of Treatment|Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)|All enrolled participants.|||participants|||Number
1285344|NCT00192023|Other Pre-specified|Open-Label Phase Nonserious Adverse Events|Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.|Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval|Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.|||participants|||Number
1285345|NCT00192023|Other Pre-specified|Open-Label Phase Serious Adverse Events|Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.|Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval|Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.|||participants|||Number
1285346|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.|||units on a scale||Standard Deviation|Mean
1285347|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(score-4.2382)*10/0.32835] + 50. Higher scores mean improvement.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.|||standard deviation units||Standard Deviation|Mean
1285348|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.|||units on a scale||Standard Deviation|Mean
1285349|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.|||units on a scale||Standard Deviation|Mean
1288802|NCT00140205|Primary|Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg|72-hour fasting Day 3 Leptin dose 0.1 mg/kg|3 DAY||||HR||Standard Deviation|Mean
1285350|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score|The scale measures symptoms of DSM-IV linked anxiety disorders in children. Contains 41 items. Individual item scores range from 0 (not true or hardly ever true) to 2 (very true or often true). Therefore, the overall score ranges from 0 to 82. Higher scores are more indicative of greater anxiety.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.|||units on a scale||Standard Deviation|Mean
1285351|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale|Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.|||units on a scale||Standard Deviation|Mean
1285352|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.|||units on a scale||Standard Deviation|Mean
1285353|NCT00192023|Primary|Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale|Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.|||units on a scale||Standard Deviation|Mean
1285354|NCT00191984|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.|||days||95% Confidence Interval|Median
1285355|NCT00191984|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.|||days||95% Confidence Interval|Median
1285356|NCT00191984|Secondary|Progression-Free Survival (PFS)|Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed.|baseline to measured progressive disease or death (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.|||days||95% Confidence Interval|Median
1285357|NCT00191984|Secondary|Duration of Response|"The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.~Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions."|time of response to progressive disease or death (up to 2 years follow-up)|All enrolled participants with at least completed cycle and who had a complete or partial response.|||days||95% Confidence Interval|Median
1285358|NCT00191984|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.~Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.|||participants|||Number
1285359|NCT00191945|Secondary|Vital Signs - Weight||Baseline and 12 weeks|All randomized participants.|||kilograms||Standard Deviation|Mean
1285360|NCT00191945|Secondary|Vital Signs - Pulse||Baseline and 12 weeks|All randomized participants.|||beats per minute||Standard Deviation|Mean
1285361|NCT00191945|Secondary|Vital Signs - Diastolic Blood Pressure||Baseline and 12 weeks|All randomized participants.|||mmHg||Standard Deviation|Mean
1285362|NCT00191945|Secondary|Vital Signs - Systolic Blood Pressure||Baseline and 12 weeks|All randomized participants.|||mmHg||Standard Deviation|Mean
1285363|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 107|Intention to Treat analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1285364|NCT00191945|Secondary|Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)|The K-SADS-PL is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis.|Baseline|Intention to Treat analysis. All randomized participants who took at least one dose of study drug.|||participants|||Number
1285365|NCT00191945|Secondary|Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(Score-4.2382)*10/0.32835]+50. Higher scores mean improvement.|Baseline to 12 weeks|Intention to Treat analysis. Last observation carried forward.|||standard deviation units||Standard Deviation|Mean
1285366|NCT00191945|Secondary|Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)|The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81.|Baseline and Week 12|Intention to Treat analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1285367|NCT00191945|Secondary|Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and Open-Label Endpoint (107 weeks)|Intention to Treat analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1285368|NCT00191945|Secondary|Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and 12 weeks|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
1285369|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|week 6 and week 12|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
1285370|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 4|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
1285371|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 6|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
1285372|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 9|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
1285373|NCT00191945|Primary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total Scores range from 0 to 54.|Week 12|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
1285374|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
1285375|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
1285407|NCT00191789|Secondary|Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery|The extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery.|baseline, after eight 21-day cycles of study drug||||participiants|||Number
1285376|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
1285377|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
1285378|NCT00191906|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|4 week therapy endpoint|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1285379|NCT00191906|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|4 week therapy endpoint|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1285380|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||T-Score of units on a scale||Standard Error|Least Squares Mean
1285381|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale|Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1285382|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale|Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1285383|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is the sum of the scores on the 18 items and range from 0 to 54.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1285384|NCT00191906|Secondary|Working Memory by Corsi Block Tapping Test (CBTT)|Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||blocks correctly sequenced||Standard Error|Least Squares Mean
1285385|NCT00191906|Secondary|Lexical Decision Task Mean Reaction Time: Pseudo Words|Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
1285427|NCT00191451|Secondary|Percentage of Patients With Overall Survival at 1 Year and 2 Years|Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years.|1 Year, 2 Years|Intent to treat population: all randomized patients. Censored patients: 31 HER2+; 19 HER2- (Taxane-); 9 HER2- (Taxane+).|||percentage of participants|||Number
1285386|NCT00191906|Secondary|Lexical Decision Task Mean Reaction Time: Correct Words|Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
1285387|NCT00191906|Secondary|Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
1285388|NCT00191906|Secondary|Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
1285389|NCT00191906|Primary|Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds (msec)||Standard Error|Least Squares Mean
1285390|NCT00191854|Secondary|Overall Survival|Overall survival time is defined as the time from the date of randomization to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow-up.|baseline to date of death from any cause (up to 34 months)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 23; Gemcitabine + Carboplatin = 24; Gemcitabine + Cisplatin = 22.|||months||Full Range|Median
1285391|NCT00191854|Secondary|Duration of Response|Duration of response was measured from time of first documentation of complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions), until date of PFS. Duration of response was censored on day of last tumor assessment for patients who had not progressed or who had discontinued study at time of analysis, and for cases where investigator determined patient had progressive disease and discontinued study therapy and/or started a new, non-protocol-specified anti-cancer therapy before documented disease progression.|time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)|Randomized patients who had either a complete response or partial response. Censored patients: Gemcitabine + Paclitaxel = 4; Gemcitabine + Carboplatin = 4; Gemcitabine + Cisplatin = 14.|||months||95% Confidence Interval|Median
1285392|NCT00191854|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment.|baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 20; Gemcitabine + Carboplatin = 18; Gemcitabine + Cisplatin = 28.|||months||95% Confidence Interval|Median
1285393|NCT00191854|Secondary|Number of Participants With a Time to Treatment Failure (TTTF) Event|TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation.|randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 34; Gemcitabine + Carboplatin = 26; Gemcitabine + Cisplatin = 30.|||participants|||Number
1285606|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Body Weight||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||kilograms (kg)||Standard Deviation|Mean
1285394|NCT00191854|Primary|Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)|Number of all randomized participants.|||participants|||Number
1285395|NCT00191815|Secondary|Number of Participants With Adverse Events Leading to Discontinuation||Baseline through eight 21-day cycles|Safety Population: all enrolled participants who received study drug.|||participants|||Number
1285396|NCT00191815|Secondary|Number of Deaths||Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|All enrolled participants.|||participants|||Number
1285397|NCT00191815|Secondary|Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades|Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).|Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)|Safety Population: all enrolled participants who received study drug.|||participants|||Number
1285398|NCT00191815|Secondary|Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination|The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)|Safety Population: all enrolled participants who received study drug.|||participants|||Number
1285399|NCT00191815|Secondary|Survival Time|Overall survival is the duration from enrollment to death due to any cause.|first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.|||weeks||95% Confidence Interval|Median
1285400|NCT00191815|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.|first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.|||weeks||95% Confidence Interval|Median
1285401|NCT00191815|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression.|first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.|||weeks||95% Confidence Interval|Median
1285402|NCT00191815|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Response population: all enrolled participants who had either a complete or partial response.|||weeks||95% Confidence Interval|Median
1285403|NCT00191815|Primary|Objective Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.|||participants|||Number
1285404|NCT00191789|Post-Hoc|Number of Participants With Time to Treatment Failure at Various Time Points|This outcome is in place of the time to treatment failure outcome. The cumulative number of participants with an event (disease progression, death as a result of any cause, or early discontinuation of treatment) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without disease progression, are alive, or did not discontinue treatment early at the beginning of each time point.|baseline to stopping treatment (up to 68 months)|Intent to treat population.|||participants|||Number
1285405|NCT00191789|Post-Hoc|Number of Participants Who Died From Any Cause at Various Time Points|The cumulative number of participants with an event (death from any cause) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants still alive at the beginning of each time point.|baseline up to 68 months|Intent to treat population.|||participants|||Number
1285406|NCT00191789|Post-Hoc|Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study|The cumulative number of participants with an event (either progressive disease or death) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without progressive disease or still alive at the beginning of each time point.|baseline up to 68 months|Intent to treat population.|||participants|||Number
1285607|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Pulse||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||beats per minute (bpm)||Standard Deviation|Mean
1285408|NCT00191789|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints.|baseline to stopping treatment (up to 68 months)|Upper limit of 95% Confidence Interval of median survival was not calculable.|||weeks||95% Confidence Interval|Median
1285409|NCT00191789|Secondary|Overall Survival|Overall survival was defined as the date of enrollment to the date of death from any cause. Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints.|baseline to date of death from any cause up to 68 months|Median was not reached|||months||95% Confidence Interval|Median
1285410|NCT00191789|Secondary|Progression Free Survival (PFS)|PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause. Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints.|baseline to measured progressive disease or death from any cause (up to 68 months)|Median was not reached.|||months||95% Confidence Interval|Median
1285411|NCT00191789|Secondary|Summary of Deaths During Study||baseline through last cycle on study drug (eight 21-day cycles)|Intent to treat population.|||participants|||Number
1285412|NCT00191789|Primary|Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)|Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.|tumor assessment at baseline and during surgery after eight 21-day treatment cycles|Intent to treat population.|||participants|||Number
1285413|NCT00191724|Secondary|Difference in Pulmonary Artery (PA) Pressure|Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.|baseline, day 6, day 90|Data were not collected.|||mm Hg||Standard Deviation|Mean
1285414|NCT00191724|Secondary|Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)|Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).|baseline and day 90 (follow-up)|Population was all randomized patients who received any study drug [drotrecogin alfa (activated) or placebo]. Patients who had no postbaseline assessment were excluded from the analyses.|||units on a scale||Standard Deviation|Mean
1285415|NCT00191724|Secondary|Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios|Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography|baseline, day 6, day 90|Population is all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo]. Patients who had no postbaseline measure at Day 6 or Day 90 were excluded from the analysis of change from baseline to day 6 or day 90, respectively.|||ratio||Standard Deviation|Mean
1285416|NCT00191724|Primary|Number of Participants With Major Bleeding Events|Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.|baseline through day 6|The population analyzed was all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo].|||participants|||Number
1285417|NCT00191646|Secondary|Overall Survival|Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to death from any cause up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 194 events, 220 censored. P/C Arm: 159 events, 254 censored.|||months||95% Confidence Interval|Median
1285418|NCT00191646|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to stopping treatment up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 336 events, 78 censored. P/C Arm: 330 events, 83 censored.|||months||95% Confidence Interval|Median
1285428|NCT00191451|Secondary|Time to Disease Progression (TTP)|If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death.|randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years)|Intent to treat population: all randomized patients. Censored patients: 10 in HER2+, 20 in HER2- (Taxane-), and 12 in HER2- (Taxane+).|||months||95% Confidence Interval|Median
1285419|NCT00191646|Secondary|Proportion of Participants With Response (Response Rate)|Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions [TL]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).|Baseline to measured progressive disease up to 82 months|All ITT participants with measurable disease at baseline (screening) for induction period; all ITT participants who crossed over to single agent therapy and had measurable disease before or at crossover for crossover period. Participants in consolidation therapy achieved CR during induction therapy and were not included in analysis.|||proportion of responders||95% Confidence Interval|Mean
1285420|NCT00191646|Primary|Progression Free Survival (PFS)|Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to measured progressive disease or death up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 292 events, 122 censored. P/C Arm: 279 events, 134 censored.|||Months||95% Confidence Interval|Median
1285421|NCT00191477|Secondary|Tumor Recurrence Type|Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition).|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population consists of the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.|||participants|||Number
1285422|NCT00191477|Secondary|Recurrence-Free Survival (RFS) in Subgroups|Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Because median time for RFS was not reached in all subgroups, patients (%) with RFS are reported as post-hoc outcome #6. There was no statistically significant difference between treatment arms in any subgroup. Population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.|||months||Full Range|Median
1285423|NCT00191477|Secondary|Time to Recurrence|Time from enrollment to first confirmation of histopathological recurrence or disease progression. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Because median time to recurrence was not reached in placebo arm, percentages of participants without recurrence are reported as post-hoc outcome measure (see #5. Post-hoc Outcome Measure). Efficacy Eligible population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.|||months||Full Range|Median
1285424|NCT00191477|Post-Hoc|Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months|RFS rate was estimated using Kaplan-Meier method. RFS was analyzed in different subgroups based on risk, disease status, and concomitant Bacillus Calmette-Guerin (BCG) instillations. Risk: Grading (G1,G2,G3) was performed according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer. Newly diagnosed disease: Initial diagnosis at study entry. Recurrent disease: history of at least one superficial bladder tumor that was surgically treated and relapsed prior to study entry. With BCG: received at least one instillation of BCG during study. Without BCG: didn't receive BCG.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population consists of the Full Analysis Set (randomized) participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.|||percentage of participants|||Number
1285425|NCT00191477|Post-Hoc|Percentage of Participants Without Tumor Recurrence|Because median time to recurrence was not reached, percentage of participants without event was estimated using Kaplan-Meier method. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population contains the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.|||percentage of participants|||Number
1285426|NCT00191477|Primary|Recurrence-Free Survival (RFS)|Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|This is the Full Analysis Set population and contains all randomized participants who received the single instillation of Gemcitabine or Placebo.|||Months||Full Range|Median
1285430|NCT00191451|Secondary|Duration of Response|Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.|date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years)|Number of patients with complete or partial response. Censored patients: 6 in HER2+, 6 in HER2- (Taxane-), and 5 in HER2- (Taxane+).|||months||Full Range|Median
1285431|NCT00191451|Primary|Overall Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to disease progression/recurrence (up to 3.5 years)|Efficacy evaluable subjects include all subjects who received at least 2 cycles of treatment with at least 1 follow-up tumor assessment, and did not violate the protocol in any fundamental manner related to the evaluation of efficacy.|||participants|||Number
1285432|NCT00191386|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the *2, *3, *4, *5, *6, *7, *8, and *10 alleles. Metabolizer status was determined by focusing on the normal(wild type, *2), decreased(*10), and defective allele(*3, *4, *5, *6, *7, or *8). PM were assigned to the patients had two defective alleles in any combination of *3, *4, *5, *6, *7, or *8 alleles. EM was all except for PM.|Over 1 year|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.|||Participants|||Number
1285433|NCT00191386|Secondary|Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)|Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.|||Units on a scale||Standard Deviation|Mean
1285434|NCT00191386|Secondary|Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.|||Units on a scale||Standard Deviation|Mean
1285435|NCT00191386|Primary|Number of Participants With Adverse Events for Long Term Safety and Tolerability|Details on the actual adverse events are presented in the Reported Adverse Events Section.|Baseline through 4 years|All patients who took at least one dose of study medication were included in the analyses of safety data.|||Participants|||Number
1285436|NCT00191334|Secondary|Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade|Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).|every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up||||participants|||Number
1285437|NCT00191334|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up||||weeks||95% Confidence Interval|Median
1285438|NCT00191334|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up||||weeks||95% Confidence Interval|Median
1285439|NCT00191334|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up||||weeks||95% Confidence Interval|Median
1285440|NCT00191334|Primary|Best Overall Tumor Response|Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up||||participants|||Number
1285441|NCT00191308|Secondary|Overall Survival (OS)|OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.|Treatment start to death from any cause (up to 47.6 months)|OS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
1285452|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 5 (Month 6)|All randomized participants with self-reported hypoglycemia during Month 6.|||episodes of hypoglycemia|||Number
1285442|NCT00191308|Secondary|Disease Free Survival (DFS)|DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.|Treatment start to disease progression or death from any cause (up to 45.5 months)|DFS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.|||months||95% Confidence Interval|Median
1285443|NCT00191308|Secondary|Duration of Response|The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions.|Time of response to disease progression (up to 44.4 months)|Duration of response was analyzed on responders treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy; responder.|||months||95% Confidence Interval|Median
1285444|NCT00191308|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate)|Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.|Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)|Tumor response rate and 95% confidence interval (CI) of best CR or PR were evaluated on all qualified enrolled participants treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.|||percentage of participants||95% Confidence Interval|Number
1285445|NCT00191308|Primary|High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood|Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.|Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)|Due to lack of eligible participants, enrollment was stopped early when 30 participants were enrolled. Tumor samples were collected in only 19 of these 30 participants. Results obtained from analyses of a small number of available samples were considered to be of little scientific and medical relevance, and tumor-tissue analyses were not conducted.|||participants|||Number
1285446|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 8 (Month 18)|All randomized participants with self-reported hypoglycemia during Month 18.|||episodes of hypoglycemia|||Number
1285447|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 18|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 8 (Month 18)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
1285448|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 7 (Month 12)|All randomized participants with self-reported hypoglycemia during Month 12.|||episodes of hypoglycemia|||Number
1285449|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 12|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 7 (Month 12)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
1285450|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 6 (Month 9)|All randomized participants with self-reported hypoglycemia during Month 9.|||episodes of hypoglycemia|||Number
1285451|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 9|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 6 (Month 9)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
1285453|NCT00191282|Other Pre-specified|Summary of Reasons for Deaths||Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285454|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 6|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 5 (Month 6)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
1285455|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 4 (Month 3)|All randomized participants who self-reported hypoglycemia during Month 3.|||episodes of hypoglycemia|||Number
1285456|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 3|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 4 (Month 3)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
1285457|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 3 (Month 1)|All randomized participants who self-reported hypoglycemia during Month 1.|||episodes of hypoglycemia|||Number
1285458|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 1|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 3 (Month 1)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285459|NCT00191282|Secondary|Number of Participants Who Experienced Coronary Angiography Planned After Randomization||Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285460|NCT00191282|Secondary|Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization||Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285461|NCT00191282|Secondary|Number of Participants Who Experienced Congestive Heart Failure|Occurrence of congestive heart failure (newly diagnosed after Visit 2).|Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285462|NCT00191282|Secondary|Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization||Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285463|NCT00191282|Secondary|Number of Participants Who Experienced Coronary Revascularization Procedures|Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.|Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285464|NCT00191282|Secondary|Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)||Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285465|NCT00191282|Secondary|Number of Participants Who Experienced Stroke|Occurrence of stroke (fatal, nonfatal, any).|Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285466|NCT00191282|Secondary|Number of Participants Who Experienced Myocardial Infarction (MI)|Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).|Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285467|NCT00191282|Secondary|Number of Participants Who Experienced Cardiovascular (CV) Death||Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285468|NCT00191282|Secondary|Number of Participants Who Experienced Death From Any Cause||Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285469|NCT00191282|Secondary|Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors|Primary outcomes adjusted for major cardiovascular (CV) risk factors (blood pressure, cholesterol [total, high density lipoprotein (HDL), and low density lipoprotein (LDL)], triglycerides, smoking, albuminuria, age, gender, and body mass index (BMI).|Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285608|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in BP||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||millimeters of Mercury (mmHg)||Standard Deviation|Mean
1285470|NCT00191282|Secondary|Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control|Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.|Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285471|NCT00191282|Secondary|Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes|Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization.|Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
1285472|NCT00191282|Primary|Number of Participants Who Experienced a Primary Combined Outcome|The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.|Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug|||participants|||Number
1285473|NCT00191269|Secondary|Pharmacokinetics - Normalized Area Under the Curve|Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.|cycle 1|Pharmacokinetic data were available on 12 participants.|||nanograms times hour per milliliter||Full Range|Geometric Mean
1285474|NCT00191269|Secondary|Pharmacokinetics - Normalized Cmax|maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.|cycle 1|Pharmacokinetic data were available from 12 patients.|||nanograms per milliliter (ng/mL)||Full Range|Geometric Mean
1285475|NCT00191269|Secondary|Survival at 1 Year|Results are reported as number of participants alive at one year.|baseline to date of death from any cause, evaluate at 1 year||||participants|||Number
1285476|NCT00191269|Secondary|Time to Progressive Disease|Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.|baseline to measured progressive disease||||days||95% Confidence Interval|Median
1285477|NCT00191269|Secondary|Duration of Response|For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.|time of response to progressive disease|The 5 responding participants (complete response and partial response) at Dose Level 2.|||months||95% Confidence Interval|Median
1285478|NCT00191269|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease||||participants|||Number
1285479|NCT00191191|Secondary|Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)|FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.|Baseline (pre-dose), 3 Months after first dose of Cycle 1|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
1285480|NCT00191191|Secondary|Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)|20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.|Baseline (pre-dose), 3 Months after first dose of Cycle 1|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
1285481|NCT00191191|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.|baseline to measured progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||months||95% Confidence Interval|Median
1285482|NCT00191191|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.|time of response to progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||months||95% Confidence Interval|Median
1285483|NCT00191191|Primary|Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||participants|||Number
1285484|NCT00191165|Secondary|Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint|Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient’s height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.|24 Months|All enrolled participants with at least one post-baseline height velocity measurement, using the last observation available prior to the 24-month visit if the 24-month height velocity was not available.|||standard deviation score||Standard Deviation|Mean
1285485|NCT00191165|Secondary|Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS)|This was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient’s height and then dividing this value by the age-and-gender-matched population height SD.|Baseline, 12-Months, 24-Months|All enrolled participants with at least one post-baseline height measurement, using last observation available prior to 12-month and 24-month visits respectively, if 12-month or 24-month height was not available.|||standard deviation score||Standard Error|Least Squares Mean
1285486|NCT00191165|Primary|Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint|Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient’s height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.|12-Months|All enrolled participants with baseline and 12-month height measurements.|||standard deviation score||Standard Deviation|Mean
1285487|NCT00191152|Secondary|Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)|RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].|First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)|Participants with RSCL at baseline (conclusion of initial treatment)and end of crossover treatment|||units on a scale||Standard Deviation|Mean
1285488|NCT00191152|Secondary|Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)|RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].|Baseline until crossover treatment began (up to 82 months)|Participants with RSCL at baseline and end of initial treatment.|||units on a scale||Standard Deviation|Mean
1285489|NCT00191152|Secondary|Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)|KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).|First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)|Participants with KPS at baseline (conclusion of initial treatment) and end of crossover treatment|||units on a scale||Standard Deviation|Mean
1285490|NCT00191152|Secondary|Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)|KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).|Baseline until crossover treatment began (up to 82 months)|Intent-to-treat population, initial treatment, participants with KPS at baseline and end of initial treatment.|||units on a scale||Standard Deviation|Mean
1285491|NCT00191152|Secondary|Best Overall Response (Crossover Treatment)|Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|Best response from start of treatment until disease progression/recurrence (up to 82 months)|Only included participants who crossed over from initial treatment to crossover treatment.|||participants|||Number
1285492|NCT00191152|Secondary|Best Overall Response (Initial Treatment)|Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|Best response from start of treatment until disease progression/recurrence (up to 82 months)|ITT population.|||participants|||Number
1285493|NCT00191152|Secondary|Overall Survival|Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.|Date of randomization to date of death from any cause (up to 82 months)|Intent to treat population: all randomized participant. Censored participants: 75 in gemcitabine/docetaxel arm; 72 in docetaxel/capecitabine arm.|||months||95% Confidence Interval|Median
1285503|NCT00191139|Secondary|Number of Patients With Overall Tumor Response|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).|randomization and every 3 months up to 2 years of post-study followup|ITT population|||participants|||Number
1285504|NCT00191139|Primary|2-Year Survival|Percentage of participants alive at 2 years.|2 years|Intention to treat (ITT) population|||percentage of participants|||Number
1285494|NCT00191152|Secondary|Duration of Response (Crossover Treatment)|At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.|Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)|ITT population: participants with CR or PR as best overall response at crossover treatment. Censored participants: 4 in capecitabine arm; 2 in gemcitabine arm.|||months||95% Confidence Interval|Median
1285495|NCT00191152|Secondary|Duration of Response (Initial Treatment)|Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.|Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)|ITT population: participants with CR or PR as best overall response (initial treatment). Censored participants: 16 in gemcitabine/docetaxel arm; 30 in docetaxel/capecitabine arm.|||months||95% Confidence Interval|Median
1285496|NCT00191152|Primary|Time to Disease Progression (Initial Treatment)|Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.|Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)|Intent-to-treat (ITT) population: all randomized participants. Censored participants in initial treatment: 68 gemcitabine/docetaxel arm; 83 docetaxel/capecitabine arm.|||months||95% Confidence Interval|Median
1285497|NCT00191152|Secondary|Progression-Free Survival (Crossover Treatment)|For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.|First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)|ITT population: all randomized participants. Censored participants, crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.|||months||95% Confidence Interval|Median
1285498|NCT00191152|Secondary|Progression-Free Survival (Initial Treatment)|For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.|Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)|ITT: all randomized participants. Censored participants (initial treatment): 64 in gemcitabine/docetaxel arm; 80 in docetaxel/capecitabine arm.|||months||95% Confidence Interval|Median
1285499|NCT00191152|Secondary|Time to Disease Progression (Crossover Treatment)|For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.|Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)|ITT population: all randomized participants. Censored participants in crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.|||months||95% Confidence Interval|Median
1285500|NCT00191139|Secondary|Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization|LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.|baseline to 3 months after last dose of study treatment (three 21-day cycles)|as-treated population|||participants|||Number
1285501|NCT00191139|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause up to 2057 days|ITT population|||days||95% Confidence Interval|Median
1285502|NCT00191139|Secondary|Progression-Free Survival|Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.|baseline to measured progressive disease up to 2057 days|ITT population|||days||95% Confidence Interval|Median
1285761|NCT00186069|Primary|Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours|The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.|48 hours after the randomization||||participants|||Number
1285505|NCT00191113|Secondary|Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data.|||participants|||Number
1285506|NCT00191113|Secondary|Maximum Glycosylated Hemoglobin|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.|||percent (%)||Standard Deviation|Mean
1285507|NCT00191113|Secondary|Glycosylated Hemoglobin, Change From Baseline|Change from core study baseline to addendum 2 maximum.|At core study baseline, and at end of 4-year addendum|Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data.|||percent (%)||Standard Error|Least Squares Mean
1285508|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value|Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio <=4.5 milligrams per 10^-4 Units (mg/10^-4U).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data. Calculated only for patients with fasting blood <100 mg/dL.|||participants|||Number
1285509|NCT00191113|Secondary|Minimum Fasting Glucose/Insulin Ratio Values|Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.|||milligrams per 10^-4 Units (mg/[10^-4]U)||Standard Deviation|Mean
1285510|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Insulin Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin >=35 micro International Units per milliliter (uIU/mL).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data|||participants|||Number
1285511|NCT00191113|Secondary|Maximum Fasting Insulin Values|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.|||micro International Units per milliliter||Standard Deviation|Mean
1285512|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Glucose Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose >=100 milligrams per deciliter (mg/dL).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data|||participants|||Number
1285513|NCT00191113|Secondary|Maximum Fasting Glucose Value|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1285514|NCT00191113|Secondary|Fasting Glucose, Change From Baseline|Change from core study baseline to addendum 2 maximum.|At core study baseline, and at end of 4-year addendum|Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data.|||mg / dL||Standard Error|Least Squares Mean
1285515|NCT00191113|Secondary|Number of Participants With Hearing Loss, Audiologist Assessment|Sensorineural Hearing Loss (SNHL)=air conduction threshold >20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold >20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap >10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present.|at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination for whom Audiologist responded to Hearing Loss question|||participants|||Number
1285516|NCT00191113|Secondary|Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination|||participants|||Number
1285517|NCT00191113|Secondary|Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination|||participants|||Number
1285518|NCT00191113|Secondary|Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination|||participants|||Number
1285519|NCT00191113|Secondary|Height (Centimeters [cm])|Most mature measurement available, at or after attainment of Final Height.|every 3 months during core study, and at start and end of 4-year addendum||||centimeters (cm)||Standard Error|Least Squares Mean
1285520|NCT00191113|Secondary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population|Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.|every 3 months during core study, and at start and end of 4-year addendum||||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
1285532|NCT00190983|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (up to 5 years)||||participants|||Number
1285521|NCT00191113|Primary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height|SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.|at completion of core study, or at end of 4-year addendum|Population of patients for whom Final Height measurements are available. Efficacy analysis with as-treated treatment groups, at most mature measurement available at or after attainment of Final Height.|||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
1285522|NCT00191113|Primary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population|Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.|Baseline, and end of 4-year addendum|Population of all randomized patients. Intent to treat analysis with as-randomized treatment groups, at most mature measurement available.|||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
1285523|NCT00191100|Secondary|Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points|Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.|||participants|||Number
1285524|NCT00191100|Secondary|Number of Participants Who Died From Any Cause at Various Time Points|Original outcome was Overall Survival, which was defined as time from baseline to death from any cause.|baseline to date of death from any cause (includes 60 month follow-up period)|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.|||participants|||Number
1285525|NCT00191100|Secondary|Tumor Response|Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Qualified Responders population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment assigned.|||participants|||Number
1285526|NCT00191100|Secondary|Local Failure Rate|Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b).|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Per protocol population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment actually received.|||proportion of participants with PD|||Number
1285527|NCT00191100|Secondary|Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points|Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.|||participants|||Number
1285528|NCT00191100|Primary|Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years|"Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted Measure Type, so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented."|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intention-to-treat population includes all randomized participants. Participants were analyzed according to treatment they were randomly assigned.|||participants|||Number
1285529|NCT00190983|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline until death from any cause (up to 5 years)||||months||Full Range|Median
1285530|NCT00190983|Secondary|Progression-Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline until documented tumor progression (up to 5 years)|All enrolled participants who experienced disease progression.|||months||Full Range|Median
1285531|NCT00190983|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of initial response until documented tumor progression (up to 5 years)|All enrolled participants who had either a complete response (n=0) or partial response (n=4).|||months||Full Range|Median
1285533|NCT00190775|Secondary|Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, after 2-week titration period beginning at Week 24|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285534|NCT00190775|Secondary|Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 2 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285535|NCT00190775|Secondary|Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 1 week|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285536|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)|Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant reports how they feel “right now at this moment” for state anxiety and how they “generally” feel for trait anxiety. The “state” items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The “trait” items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 4-80 for each scale. Higher scores indicate more impaired participants.|Baseline, 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285537|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)|The MADRS is an investigator administered rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285538|NCT00190775|Secondary|Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)|The CGI-ADHD-S is a single-item rating of the clinician’s assessment of the severity of ADHD symptoms in relation to the clinician’s total experience with ADHD subjects. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). The scale was administered by a physician or PhD at the investigative site.|Baseline, 8 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285539|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores|18-item scale that captures the 18-item DSM-IV symptoms of ADHD. 9 inattentive items alternate with 9 hyperactive/impulsive items. Each item is scored 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The total score range is 0-54 (0-27 for each subscale). Higher scores indicate more impaired participants. The scale was administered by a physician or PhD at the investigative site.|Baseline, 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285540|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale|16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1286601|NCT00168844|Secondary|Weekly Mean Evening PEFRs|Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Litres/minute||Standard Error|Mean
1285541|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale|16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285542|NCT00190775|Secondary|Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags|Items 19-26 of the CDBRS assess the presence of Oppositional Defiant Disorder (ODD) (yes if participant answers >=4 items as 2 [often] or 3 [very often]). Items 1-26 are rated on a 0-3 scale (0=never/rarely, 1=sometimes, 2=often, 3=very often). 15 yes/no items assess the presence of Conduct Disorder (yes if >3 items answered yes). Participants with a child 6-12 years old living in the home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Participants|||Number
1285543|NCT00190775|Secondary|Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form|Contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscale). Higher scores indicate greater impairment. Participants with a child 6-12 years old living in the home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285544|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.|Baseline, 24 Weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285545|NCT00190775|Secondary|Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.|Baseline, 12 Weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285546|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285547|NCT00190775|Secondary|Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.|Baseline, 12 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285548|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285577|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Visceral Fat Area|Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan of changes from baseline to last observation of randomized patients who completed baseline and endpoint clamps with both diet stabilizations|||square centimeters (cm2)||Standard Deviation|Mean
1285549|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285550|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress|The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285551|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285552|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285553|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress|The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
1285554|NCT00190775|Primary|Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 12 weeks|Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included. The protocol was amended to extend the open-label portion of the study from 8 weeks to 12 weeks, and the primary objective was modified to include the CAARS-IV:SV at 12 weeks.|||Units on a scale||Standard Error|Least Squares Mean
1285555|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other|32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
1285578|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Waist Circumference|Waist circumference change from baseline to last observation carried forward.|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||centimeters||Standard Deviation|Mean
1285579|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Weight change from baseline to last visit (last observation carried forward)|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||kilograms||Standard Deviation|Mean
1285556|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other|32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
1285557|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant|32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
1285558|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant|32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
1285559|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
1285560|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
1285561|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
1285562|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
1285580|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Body Mass Index|Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations|||kilograms per square meter (kg/m2)||Standard Deviation|Mean
1285626|NCT00189488|Secondary|Number of Participants With Parenteral or Transdermal Opioid Analgesic Use|Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.|From transplant (Day 0) until Day 100|Primary Analysis Set|||Participants|||Number
1285563|NCT00190775|Primary|Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 24 weeks|Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included.|||Units on a scale||Standard Error|Least Squares Mean
1285564|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses|Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein.|baseline and 12 weeks.|Mean change from baseline, all randomized patients, double-blind treatment period|||nanomoles per Liter (nmol/L)||Standard Deviation|Mean
1285565|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides|Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1285566|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)|Fasting lipid parameters including HDL change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1285567|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)|Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1285568|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol|Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1285569|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores|Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always).|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
1285570|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores|Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
1285571|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores|The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
1285572|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores|A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
1285573|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
1285574|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores|Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24.|baseline and 12 weeks|BPRS Total and Subscale Scores-Change from Baseline to Last Observation Carried Forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
1285575|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area|Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan change from baseline to last observation of randomized patients who completed the baseline and endpoint clamps with both diet stabilizations|||ratio in square centimeters (cm2)||Standard Deviation|Mean
1285576|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area|Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan change from baseline to last observation for randomized patients who completed baseline and endpoint clamps with both diet stabilizations|||square centimeters (cm2)||Standard Deviation|Mean
1285581|NCT00190749|Secondary|Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285582|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285583|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations|||correlation|||Number
1285584|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations|||correlation|||Number
1285585|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285586|NCT00190749|Secondary|Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285587|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285588|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285589|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.|Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285590|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285591|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285592|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
1285593|NCT00190749|Primary|Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate|Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)]|baseline and 12 weeks|N=number of patients with a baseline and post-baseline result within each treatment group for Mffm/I and weight.|||Mffm/I||Standard Deviation|Mean
1285594|NCT00190684|Primary|Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group|"Tanner Stage:~I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs~Age Groups:~age<11.0 (female) and age<12 (male)~11=<age<12 (female) or 12<=age<13 (male)~12=<age<15 (female) or 13=<age<15 (male)~age>=15 (female and male)"|1 year through 5 years|The analysis population is defined as patients with at least two Tanner measurements.|||participants|||Number
1285605|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Height||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||centimeters (cm)||Standard Deviation|Mean
1285595|NCT00190684|Primary|Number of Participants With Abnormal Laboratory Analytes During the Study|Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10^12 units/liter; Giga/liter (GI/L)or 10^9 units/liter; femtoliters (fL); urinalysis (UA)|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||participants|||Number
1285596|NCT00190684|Primary|Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is <430 ms, Borderline is >=430 ms and <450 ms, Prolonged is >=450 ms. For Females: Normal is <450 ms, Borderline is >=450 ms and <470 ms, Prolonged is >=470 ms.|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||participants|||Number
1285597|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test|Only patients who took the Stroop Color Word Test in a previous atomoxetine study were required to complete the Stroop in this study. Stroop measures inhibition of dominant response and interference control. Patients were given tasks of recognition (colors), reading (where a word represents a color), and interference (reading words written in different colors). There were 100 items for each of the three categories and if they made it through 100 words with time remaining, they would repeat the list. Only a small number of patients had Stroop tests in this study, so no analysis was done.|baseline, 5 years|There were not enough participants with prior Stroop Word Color tests to analyze the data.|||number of correct answers||Standard Deviation|Mean
1285598|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||units on a scale||Standard Deviation|Mean
1285599|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||units on a scale||Standard Deviation|Mean
1285600|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Hyperactive/Impulsive and Inattention Subscales consisted of 9 items each, for total subscale score range of 0 to 27. ADHD Index Subscale consisted of 12 items, for total score range of 0 to 36.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||units on a scale||Standard Deviation|Mean
1285601|NCT00190684|Primary|Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children.|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||participants|||Number
1285602|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Heart Rate|Patients were assessed for changes in heart rate using electrocardiogram.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||beats per minute (bpm)||Standard Deviation|Mean
1285603|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)|Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||milliseconds (msec)||Standard Deviation|Mean
1285604|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile|Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and 5 year endpoint measurement.|||percentiles||Standard Deviation|Mean
1288803|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg|72-hour fasting Day 3 Leptin dose 0.01 mg/kg|3 DAY||||NG*H/ML||Standard Deviation|Mean
1285609|NCT00190684|Primary|Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study|Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.|Baseline through 5 years|For each vital sign, the number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug. Number of subject analyzed for each vital sign is provided.|||participants|||Number
1285610|NCT00190671|Secondary|Pharmacokinetics - Half-Life (t½)|The half-life associated with the terminal elimination rate constant.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||hours||Full Range|Geometric Mean
1285611|NCT00190671|Secondary|Pharmacokinetics - Volume of Distribution|Central volume (V1) and peripheral volume (V2) of distribution.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||Liters||Full Range|Geometric Mean
1285612|NCT00190671|Secondary|Pharmacokinetics - Clearance (CL)|Total body clearance of drug calculated after intravenous administration.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||milliliters per minute||Full Range|Geometric Mean
1285613|NCT00190671|Secondary|Pharmacokinetics - Area Under the Curve (AUC)|Area under the gemcitabine concentration-time curve from zero to last quantifiable concentration [AUC(0-t)] was calculated by combination of linear and logarithmic trapezoidal methods. Linear trapezoidal method was employed up to tmax (time to reach maximal concentration), and then log trapezoidal method was used for those data after tmax.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||hour times microgram per milliliter||Full Range|Geometric Mean
1285614|NCT00190671|Secondary|Pharmacokinetics - Maximum Observed Drug Concentration (Cmax)||cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||micrograms per milliliters||Full Range|Geometric Mean
1285615|NCT00190671|Secondary|Progression Free Survival|Defined as date of first treatment dose to first date of progressive disease or death from any cause. For patients not known to have died as of data cutoff date and who did not have progressive disease, the progression free survival date was censored at last contact date.|baseline to measured progressive disease|All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). The Progression Free Survival date was censored for 22 (35.07%) participants.|||months||95% Confidence Interval|Median
1285616|NCT00190671|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from the date of the first treatment dose to the first date of progressive disease or death from study disease.|baseline to measured progressive disease|All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). Time to disease progression was censored for 26 (42.6%) participants.|||months||95% Confidence Interval|Median
1285617|NCT00190671|Primary|Best Tumor Response|Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.|baseline to measured progressive disease|Number of randomized participants.|||participants|||Number
1285618|NCT00189540|Secondary|Change in Hemodynamic Measurements - Mean Change in Toe Brachial Index (TBI)||Baseline, Month 3, Month 6|Population is per protocol - Efficacy Evaluable (EE)|||mm Hg / mm Hg||Standard Error|Mean
1285619|NCT00189540|Secondary|Change in Hemodynamic Measurements - Mean Change in Ankle Brachial Index (ABI)||Baseline, Month 3, Month 6|Population is per protocol - Efficacy Evaluable (EE)|||mm Hg / mm Hg||Standard Error|Mean
1285620|NCT00189540|Secondary|Number of Subjects Who Undergo a Major Amputation||Month 3 and Month 6||||participants|||Number
1285621|NCT00189540|Secondary|Change in Pain at Rest as Measured on the Visual Analog Scale (VAS)|The mean VAS score where 0 = no pain; 10 = worst possible pain.|Baseline, Month 3 and Month 6|"Per protocol population or Efficacy Evaluable EE"|||cm||Standard Error|Mean
1285622|NCT00189540|Secondary|Percentage of Participants Where All Ulcers Healed|This outcome is a percentage of participants where all of their baseline ulcers healed.|Month 3 and Month 6|"Per protocol population Efficacy Evaluable EE"|||Percentage of Participants|||Number
1285623|NCT00189540|Primary|Wound Healing (Change in Total Wound Area of All Ischemic Ulcers)|Wound healing measured by change in mean total wound area of all ischemic ulcers at Month 3 and Month 6|Baseline, Month 3, Month 6|Per protocol population - Efficacy Evaluable or EE|||total wound area (cm^2)||Standard Error|Mean
1285624|NCT00189488|Secondary|Area Under the Curve (AUC) of Mouth and Throat Soreness Score|"The modified Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS.~The modified OMDQ was completed once daily beginning with the first day of study drug administration through day 28.~The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness)."|The first day of study drug administration through Day 28.|Primary analysis set|||MTS score * days||Standard Deviation|Mean
1285625|NCT00189488|Secondary|Duration of Hospitalization|Duration of hospitalization was defined as the number of days a participant stayed in hospital (hospitalized) during the period starting from the day of the transplant (Day 0) to the 100th day following the transplant.|From transplant (Day 0) until Day 100|Primary analysis set|||days||Standard Deviation|Mean
1285627|NCT00189488|Secondary|Duration of Severe Oral Mucositis (WHO Grade 3 and 4)|The duration of severe oral mucositis was calculated as the number of days from the onset of severe mucositis (first time a WHO grade of 3 or 4 was observed) to the last day when severe mucositis was observed. If oral mucositis assessments were recorded as missed visits immediately prior to or immediately after severe mucositis was recorded, the missed visits were considered to be severe oral mucositis.|From transplant (Day 0) until Day 100|Primary Analysis Set|||days||Standard Deviation|Mean
1285628|NCT00189488|Secondary|Number of Participants With Severe (Grade 3 or 4) Oral Mucositis|"Oral cavity assessments were performed by a trained assessor using the World Health Organization (WHO) oral toxicity scale. Daily oral mucositis assessments were performed:~while participants were hospitalized, including the day of discharge (maximum until day 28);~after discharge until the oral mucositis grade returns to a WHO grade ≤ 2.~The WHO oral toxicity criteria are: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible."|From transplant (Day 0) until Day 100|Primary Analysis Set|||Participants|||Number
1285629|NCT00189488|Secondary|Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration|Low dose methotrexate is widely used in regimens to prophylax against acute GVHD. Methotrexate was administered on days 1, 3, 6 and 11 (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2, respectively.|Day 11|Primary Analysis Set|||Participants|||Number
1285630|NCT00189488|Primary|Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)|"GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.~Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.~Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.~Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL."|From transplant (Day 0) until Day 100|Primary Analysis Set (consisting of all randomized participants) with GVHD assessments. Efficacy analyses were according to randomized treatment assignment.|||Participants|||Number
1285631|NCT00189488|Secondary|Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)|"GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.~Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.~Grade 2 GVHD = > 50% skin involvement or total bilirubin 2.0 - 3.0 mg/dL or 500 - 999 mL/day diarrhea, or persistent nausea with histologic evidence.~Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.~Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL."|From transplant (Day 0) until Day 100|Primary Analysis Set (consisting of all randomized participants) with GVHD assessments.|||Participants|||Number
1285632|NCT00189475|Primary|Nasal Secretion Weights||6 days after naturally acquiring an upper respiratory infection||||grams||Standard Error|Mean
1285633|NCT00189462|Primary|Incidence of Acute Otitis Media||16 weeks||||participants with AOM|||Number
1285634|NCT00189436|Secondary|Spirometry Readings||3 weeks|||||||
1285635|NCT00189436|Secondary|Urinary Cortisol||3 weeks|||||||
1285636|NCT00189436|Primary|Wheezing/Asthma/Bronchospasm Relapse Rate|Asthma relapse rate was 6.5% and 4% in the nebulized budesonide and standard care groups, respectively|3 weeks||||percentage of cases of asthma relapse|||Number
1285637|NCT00189423|Secondary|Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)]|CASI is scored on a scale of 0-100 with 100 being the best score. The instrument evaluates attention, concentration, and short- and long-term memory as well as language and abstraction. The CASI score is a total score and not an aggregate of subscores.|One year after index arrest||||units on a scale||Standard Deviation|Mean
1285638|NCT00189423|Secondary|Survival to 365 Days|Number of patients who are alive 365 days after the index cardiac arrest.|365 days following cardiac arrest|Population is a modified Intent to Treat (mITT) population who met initial and final inclusion criteria.|||patients|||Number
1285639|NCT00189423|Secondary|Survival to 90 Days|Number of patients who are known to be alive 90 days after the index cardiac arrest.|90 days following cardiac arrest|Population is a modified Intent to Treat (mITT) population that met initial and final inclusion criteria.|||patients|||Number
1285640|NCT00189423|Secondary|Survival to Hospital Discharge||cardiac arrest to hospital discharge||||patients|||Number
1285641|NCT00189423|Secondary|Survival to 24 Hours|Number of patients who were alive 24 hours after the initial cardiac arrest.|24 hours following cardiac arrest|Population is a modified Intent to Treat (mITT) population who met ititial inclusion criteria and final inclusion criteria.|||patients|||Number
1285642|NCT00189423|Secondary|Survival to Hospital (e.g., Intensive Care Unit) Admission|Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.|Time of hospital admission, up to 1 day after cardiac arrest|Population is a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and also met final inclusion criteria.|||patients|||Number
1285643|NCT00189423|Secondary|Return of Spontaneous Circulation (ROSC)|Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS.|Time of cardiac arrest until discontinuation of efforts|Population was a modified Intent to Treat (mITT) population that consisted of patients who met all initial and final inclusion criteria.|||patients|||Number
1285644|NCT00189423|Secondary|Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events|Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury.|Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge|Population is a modified Intent to Treat (mITT) population consisting of patients who met all initial and final inclusion criteria.|||patients|||Number
1285645|NCT00189423|Primary|Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3|favorable neurologic function is defined as modified Rankin Scale (MRS) score <= 3. Modified Rankin Scale measures functional outcome in stroke. It is a scale of 0-5 where 0=no symptoms at all and 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention.|When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge|The population was a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and who were finally included in the final analysis population after meeting final inclusion criteria.|||patients|||Number
1285646|NCT00189306|Secondary|Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks|Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)|12 week posttreatment visit|Two data sets were analyzed: intent-to-treat (ITT), consisting of all enrolled subjects and per-protocol (PP), consisting of ITT subjects who were free from major protocol violations, and who applied at least 60% of the doses required by the dosing regimen.|||participants|||Number
1285647|NCT00189306|Primary|Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)|Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.|5 years|2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required|||participants|||Number
1285648|NCT00189202|Secondary|Blood Pressure Control|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication|12 months||||Participants|||Count of Participants
1285649|NCT00189202|Secondary|Drug-treated Dyslipidemic Syndrome|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome|12 months||||Participants|||Count of Participants
1285650|NCT00189202|Secondary|Incidence of Post Transplant Diabetes|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus|12 months||||Participants|||Count of Participants
1285651|NCT00189202|Primary|One-year Patient Survival|To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival|12 months||||Participants|||Count of Participants
1285652|NCT00189202|Primary|One-year Graft Survival|To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival|12 months||||Participants|||Count of Participants
1285653|NCT00189202|Primary|Cumulative One-year Acute Rejection Rates|To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant|12 months||||Participants|||Count of Participants
1285654|NCT00189137|Secondary|The Percentage of Patients Alive Without Disease at 2 Years|Disease-free survival|2 years||||percentage of patients|||Number
1285655|NCT00189137|Primary|Percentage of Patients Hospitalized in Each Arm.|To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.|12 weeks||||percentage of patients hospitalized|||Number
1285656|NCT00189098|Secondary|Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.|After 12 weeks follow-up irrespective of the presence or absence of otorrhea the study medication was discontinued. After the first 12 weeks local otorhinolaryngologists and paediatricians were free to manage symptoms of otorrhea according to their regular practice. Parents kept a diary between 12 weeks and 1 year follow-up where Ear Nose and Throat Surgery was noted. This outcome describes the number of patients who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|between 12 weeks and 1 year follow-up||||participants|||Number
1285657|NCT00189098|Secondary|Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.|between 12 weeks and 1 year follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.|||participants|||Number
1285658|NCT00189098|Secondary|Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.|between 6 and 12 weeks follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.|||participants|||Number
1285659|NCT00189098|Secondary|Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits.|between 12 weeks to 1 year follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.|||participants|||Number
1285660|NCT00189098|Secondary|Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits.|Between 6 to12 week follow up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.|||participants|||Number
1285661|NCT00189098|Primary|Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear|The primary endpoint was otomicroscopic signs of otorrhea in either ear in the presence of a tympanostomy tube or tympanic membrane perforation at 6 and 12 weeks and 1 year follow-up. At these follow-up moments the participants were checked for the presence of otorrhea using an otomicroscope.|6, 12 weeks and 1 year follow-up.|intention to treat|||participants|||Number
1285662|NCT00187889|Secondary|Microvascular Coronary Flow Reserve(Adjusted) at Week 16 Adjusted for Baseline Coronary Flow Reserve Comparing the Eplerenone Group to the Placebo Group|Coronary flow reserve is a ratio of coronary blood flow velocity before and after adenosine. The outcome measure is the difference between the coronary flow reserve at 16 weeks adjusted for coronary flow reserve at baseline.|16 weeks|See Primary Outcome. The studied was only powered for the primary outcome. All completers are included per protocol analysis.|||difference of ratios (unitless)||Standard Deviation|Mean
1285663|NCT00187889|Primary|Epicardial Coronary Artery Endothelial Function (Adjusted) at Week 16 Comparing the Eplerenone Group to the Placebo Group|The primary measure was the relative change in coronary diameter to acetylcholinem (ACH) at 16 weeks adjusted for baseline reactivity to acetylcholine. Change in coronary artery diameter after ACH was measured in mm at baseline and 16 weeks. Percent change at 16 weeks - percent change at baseline was the outcome.|16 weeks|power analysis: Study planned to detect a 12% difference in change from baseline to 16 weeks between treatment groups (SD=14%), in the primary outcome leading to a planned sample size of 22 per group (44 total) for 80% power, P=0.05 2-sided. Study allowed for 6 dropouts, leading to a final N=50 planned (25 per group). Per protocol analysis used.|||% change wk16-%change wk0- unitless||Standard Deviation|Mean
1285664|NCT00187876|Primary|International Knee Documentation Committee (IKDC) Form|The IKDC Subjective Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0-100. A score of 100 is interpreted to mean no limitation with activities of daily living and the absence of symptoms.|24 month period||||score||95% Confidence Interval|Mean
1285665|NCT00187720|Primary|Renal Clearance of Metformin|To test whether individuals with genetic variants of the human organic cation transporter, OCT2, exhibit altered renal elimination of metformin we will measure the difference in renal clearance between reference and variant groups.|0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours|Analysis was per protocol. The sample size of 23 subjects will enable us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the renal clearance of metformin between individuals who are homozygous for the reference OCT2 and those who carry the OCT2 variant A270S allele.|||mL/min||Standard Deviation|Mean
1285666|NCT00187681|Primary|Glucose Lowering Response to Metformin|To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered glucose lowering response to metformin we will measure the difference in area under the glucose concentrations-time curve (Glucose AUC) following oral glucose tolerance test.|0 to 180 minutes|20 participants were analyzed as per protocol. The sample size of 20 subjects enabled us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the pharmacodynamics of metformin between individuals who are homozygous for the reference OCT1 and those who carry an OCT1-R61C, OCT1-G401S or OCT1-G465R allele.|||min * mg/dL||Standard Deviation|Mean
1285667|NCT00187681|Primary|Area Under the Curve (AUC) of Blood Concentration-time of Metformin|To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered pharmacokinetics of metformin, the difference in AUC of blood concentration-time of metformin between reference and variant groups will be measured.|0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours|20 participants were analyzed as per protocol. The sample size of 20 subjects enabled us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the pharmacokinetics of metformin between individuals who are homozygous for the reference OCT1 and those who carry an OCT1-R61C, OCT1-G401S or OCT1-G465R allele.|||hour * µg/L||Standard Deviation|Mean
1285668|NCT00187655|Primary|Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype|Participants were stratified by their OCT3 genotype, heterozygous vs homozygous. The renal clearance of cefotaxime was measured by urine content of cefotaxime metabolites in participants after the single IV push administration of 2 grams of cefotaxime.|post dose up to 24 hours|The OAT3 Ile305Phe variant was determined to be heterozygous or homozygous for each healthy participant.|||mL/min||Standard Deviation|Mean
1285669|NCT00187486|Secondary|Progression Free Survival|Progression based on MR imaging using the Modified McDonnald Criteria defined as 25% increase in sum of products of all measured lesions or any new lesion|every 2 months measure by MR imaging, up to 39 months||||months||Full Range|Median
1285670|NCT00187486|Primary|Overall Survival|Patients were monitored until death|assessment of survival was every 2 months, up to 181 weeks|The analysis was per protocol, and intention to treat. Median overall survival measured from the date of registration was the primary endpoint.|||months||Full Range|Median
1285671|NCT00187226|Primary|Local Tumor Control|Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.|12 months after the enrollment of the last therapeutic patient|Patients with Ependymoma, Craniopharyngioma, Low-grade Glioma, and High-grade Glioma were analyzed by diagnosis.|||Proportion of patients||95% Confidence Interval|Log Mean
1285672|NCT00187200|Secondary|Left Ventricular Ejection Fraction (LVEF)|Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. The left ventricle is the heart's main pumping chamber, so ejection fraction is usually measured only in the left ventricle (LV).|Randomization and 9 months||||percentage||Standard Deviation|Mean
1285674|NCT00187200|Secondary|NYHA Class Progression|New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.|6 months|Per protocol analysis|||participants|||Number
1285675|NCT00187200|Primary|CRT Responder Rate|Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.|6 months|Per protocol analysis.|||participants|||Number
1285676|NCT00187135|Secondary|Movement|Movement (yes/no) measured during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.|||Participants|||Number
1285677|NCT00187135|Secondary|20% or Greater Change in Blood Pressure|Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.|||Participants|||Number
1285678|NCT00187135|Secondary|20% or Greater Change in Respiratory Rate|Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.|||Participants|||Number
1285679|NCT00187135|Secondary|20% or Greater Change in Heart Rate|Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.|||Participants|||Number
1285680|NCT00187135|Primary|Pain (Yes/No)|During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 – 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded “pain”, and score of 0 was coded “no pain”, yielding one score for each participant’s procedure.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.|||Participants|||Number
1285681|NCT00187135|Primary|Pain(Yes/No)|During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 – 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded “pain”, and score of 0 was coded “no pain”, yielding one score for each participant’s procedure.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.|||Participants|||Number
1285682|NCT00187096|Secondary|Overall Survival|"Overall survival is defined as the time relapse from on study date to death with those alive at last follow up date censored. The Kaplan-Meier method was used to compute survival probability estimates and confidence interval was determined by binomial distribution (for no events or all events) or by log hazard method. The binomial interval is based on the number of patients at risk.~The confidence intervals for Arm 1 and Arm 2a were determined by binomial distribution.~The confidence interval for Arm 2b was determined by log hazard method."|Up to 2 years post NK cell transplantation||||Percent probability||95% Confidence Interval|Number
1285683|NCT00187096|Secondary|Relapse-free Survival|For Arm 1, the efficacy of NK cell transplantation will be reported as the proportion of participants who achieve complete or partial remission. Kaplan-Meier estimates of relapse-free survival and confidence interval was determined by binomial distribution because no events were observed. The binomial interval is based on the number of patients at risk.|Up to 2 years post NK cell transplantation||||Percent probability||95% Confidence Interval|Number
1285684|NCT00187096|Secondary|Number of Participants With Evidence of NK Cells Lysing a Target Cell Line (K562)|NK cells in recipient achieving ability to lyse target cell line (K562) within normal range established by donor NK cells.|Days 2, 7, 14, 21, and 28 after NK cell transplantation|All 10 participants received NK donor cells; 9 of the 10 participants received KIR-mismatched NK donor cells.|||participants|||Number
1285685|NCT00187096|Secondary|Number of KIR-mismatched NK Cells|Number of KIR-mismatched donor NK cells in recipients’ blood at day 2 and day 14 post NK cell infusion.|Day 2 and day 14 post NK cell transplantation|Nine of the 10 participants in Arm 1 received KIR-mismatched NK donor cells.|||cells/µl||Full Range|Median
1285686|NCT00187096|Secondary|Day That Maximum NK Cell Engraftment Was Reached|The time elapsed after transplantation in days until peak KIR-mismatched donor NK cell expansion was reached in recipients|Day 0 through Day 28 post NK cell transplantation|Nine of the 10 participants in Arm 1 received KIR-mismatched NK donor cells.|||number of days||Full Range|Median
1285687|NCT00187096|Secondary|Percent of Detectable Donor NK Cells at Day 28|The percent of detectable donor NK cells in recipients at 28 days after NK cell infusion. Three of 10 participants had detectable donor cells at week 4. The results report the percent of detectable cells in the 3 participants.|At 28 days|Three of 10 participants continued to have detectable donor NK cells at week 4.|||percent of donor NK cells||Full Range|Median
1285688|NCT00187096|Secondary|Percent of Peak NK Cell Chimerism|The maximum percent of donor NK cell in recipients during a four-week period after NK cell infusion.|Days 2, 7, 14, 21 and 28 after NK cell transplantation|Arm 2 participants were not analyzed for this outcome as many of these patients proceeded to allogeneic stem cell transplantation following NK cell transplantation.|||percent of NK cells||Full Range|Median
1285689|NCT00187096|Secondary|Duration of Engraftment of Natural Killer (NK) Cells|NK cell engraftment defined as NK cell chimerism in recipients.|Measured at days 2, 7, 14, 21 and 28 after NK cell transplantation, and up to 189 days post transplant as clinically indicated|Arm 2 participants were not analyzed for this outcome as many of these patients proceeded to allogeneic stem cell transplantation following NK cell transplantation.|||Days||Full Range|Median
1285690|NCT00187096|Primary|Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant|Document the proportion of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.|Beginning at on therapy through 100 days post-transplant|Grade 3 and 4 toxicities were assessed using Common Toxicity Criteria V.3.0 The assessment period was from the date on therapy through 100 days post-transplant.|||proportion of patients|||Number
1285691|NCT00187096|Primary|Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant|Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.|Beginning at on therapy through 100 days post-transplant|Grade 3 and 4 toxicities were assessed using Common Toxicity Criteria V.3.0 The assessment period was from the date on therapy through 100 days post-transplant.|||participants|||Number
1285692|NCT00186901|Secondary|Mean QCT Z-Score by Bsm 1 Vitamin D Receptor Genotype|The Bsm1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood|At enrollment|Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Bsm 1 vitamin D receptor, only 41 had the BB genotype, 65 had the Bb genotype, and 77 had the bb genotype.|||QCT Z-Score||Standard Deviation|Mean
1285693|NCT00186901|Secondary|Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype|The Apa1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood|At enrollment|Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Apa 1 vitamin D receptor, only 68 had the AA genotype, 104 had the Aa genotype, and 49 had the aa genotype.|||QCT Z-Score||Standard Deviation|Mean
1285694|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 180 patients were assessed at 36 months by the QCT method and 89 were evaluated using the DXA methods to assess Bone Mineral Density. 89 patients received both scans.|36 months|180 patients were assessed at the 36 months interval and received a QCT Scan. 89 patients were also assessed using the DEXA Scan. Comparison of the two methods produced 89 paired studies to arrive at a correlation.|||Z-score||Standard Deviation|Median
1285695|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 188 patients were assessed at 24 months by the QCT method and 90 were evaluated using the DXA methods to assess Bone Mineral Density. 90 patients received both scans.|24 months|188 patients were assessed at the 24 months interval and received a QCT Scan. 90 patients were also assessed using the DXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation.|||Z-score||Standard Deviation|Mean
1285696|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 218 patients were assessed at 12 months for QCT. 94 were evaluated using DXA. 94 patients received both scans.|12 months|218 patients were assessed at the 12 months interval and received a QCT Scan. 94 patients were also assessed using the DXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation.|||Z-score||Standard Deviation|Mean
1285697|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 121 patients at baseline were assessed by both method the QCT and DXA methods to assess Bone Mineral Density.|Baseline|275 patients were assessed at baseline and received a QCT Scan. 121 patients were also assessed using the DEXA Scan. Comparison of the two methods used 121 paired studies to arrive at a correlation coefficient.|||Z-score||Standard Deviation|Mean
1285698|NCT00186901|Primary|Bone Mineral Density by Age Group of ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (age groups) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Assess baseline participants to determine whether age was a contributing factor in bone mineral density.|||Z-score||Standard Error|Median
1285699|NCT00186901|Primary|Bone Mineral Density by Race of ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (race) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Assess baseline participants to determine whether race contributed to bone mineral density.|||Z-score||Standard Error|Median
1285700|NCT00186901|Primary|Bone Mineral Density in Male and Female ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (gender) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Baseline participants were assessed to determine whether gender was a pre-disposing factor for bone mineral density.|||Z-score||Standard Error|Median
1285701|NCT00186901|Primary|Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)|The effect of taking calcium and vitamin D supplements was measured using Quantitative Computed Tomography (QCT) to calculate a QTC Z score. A standardized Z-score was calculated to indicate the difference between the patient’s Bone Mineral Density (BMD) and the mean value for age and gender-appropriate controls. Z-scores from 0 to +2 are considered normal, above +2 are considered to be elevated, from 0 to -1 are considered to represent a mild BMD deficit, between -1 and -2 are considered to represent moderate deficits, and below -2 are considered to represent severe deficits.|Baseline, 12 months, 24 months, and at 36 months or study end|Of the 275 pts identified with BMD z-scores < 0, 134 were randomized to the placebo group and 141 to the supplement group. Bone Mineral Density QCT Z-scores were calculated at baseline, 12 months, 24 months, and at 36 months or study end.|||Z-Score||Full Range|Median
1285702|NCT00186888|Secondary|Mean Primary Visual Cortex Function: Maximum T-value|"Functional magnetic resonance imagining (fMRI) was used to investigate primary visual cortex (V1) response to visual stimulation in 105 children being treated for intraocular retinoblastoma. Primary visual cortex activity was assessed in each subject using blood oxygenation level-dependent (BOLD) signal. The BOLD signal was analyzed via a general linear model using Statistical Parametric Mapping software (SPM, Wellcome Institute of Neurology, London). The maximum t-statistic in activated cluster (negative BOLD) is provided.~Voxel volume/peak BOLD response is a measurement of the volume of activation of the cortex. There is no known association with visual outcome at this time."|At diagnosis through 6 years after last patient enrollment||||Maximum t-statistic (negative BOLD)|Number of exams|Standard Deviation|Mean
1285703|NCT00186888|Post-Hoc|Number of Patients Recommended for and Utilizing Rehabilitation Services|"Participants were evaluated by Occupational Therapy at diagnosis, and at 3, 6, 9, and 12 months from diagnosis with a battery of standardized and non-standardized measures. Assessments including the Battelle Developmental Inventory, the Sensory Profile, the Oregon Project for Visually Impaired Preschoolers, Pediatric Evaluation of Disability Inventory, and the Greenspan Social Emotional Growth Scale were utilized for developing the participants plan of care and making referrals for services in the home community. Recommendations for rehabilitation services in the home community were made based on the results of the occupational therapists evaluation.~A subsequent review of February 2013 subgroup definitions resulted in the reclassification of evaluable participants and subgroups in May 2015. This reclassification applies to the data for this outcome only."|At diagnosis, and at 3, 6, 9, and 12 months from diagnosis|Objective was added after the protocol started. Due to the late start, 33 of the 105 overall participants were eligible. Of the 33, 1 family declined to participate; 1 was removed from the protocol, 5 were lost to follow-up, and 4 patients were unable to complete the developmental assessment. In total, 22 have complete data sets.|||participants|||Number
1285704|NCT00186888|Secondary|Mean Primary Visual Cortex Function: Cluster Size|"Functional magnetic resonance imagining (fMRI) was used to investigate primary visual cortex (V1) response to visual stimulation in 105 children being treated for intraocular retinoblastoma. Primary visual cortex activity was assessed in each subject using blood oxygenation level-dependent (BOLD) signal. The BOLD signal was analyzed via a general linear model using Statistical Parametric Mapping software (SPM, Wellcome Institute of Neuology, London).~Voxel volume/peak BOLD response is a measurement of the volume of activation of the cortex. There is no known association with visual outcome at this time."|At diagnosis through 6 years after last patient enrollment||||number activated voxels (negative BOLD)|Number of exams|Standard Deviation|Mean
1285705|NCT00186888|Secondary|Change in Distortion Product Otoacoustic Emissions (DPOAEs)|For DP_amplitude to be considered valid, a baseline DP_SNR (Distortion Product for Signal-to-noise ratio) for each frequency (1000-8000 Hz) and for each ear (left and right) must be = 6 dB. Any ear with invalid amplitude at baseline for each frequency should be excluded. The DPOAEs amplitude levels were averaged across the right and left ears at each frequency in the patients exhibiting valid DPOAE amplitudes in both ears, resulting in mean DPOAE levels. Subsequently, comparisons between baseline and most recent evaluation (collapsed across ears) for each frequency were made to evaluate if a significant decrease in DPOAE amplitude exists between the two time points.|From Diagnosis through 5 years after completion of therapy|A total of 14 patients had “Incomplete data” and were not included in the analysis.|||dB||Standard Deviation|Mean
1285706|NCT00186888|Secondary|Number of Participants With Change in Size of Pineal Gland|The MRI reports from bilateral patients were reviewed and data abstracted regarding pineal gland measurement and information about pineal cysts. The number of participants with change in pineal gland size is reported here.|From diagnosis through 6 years after last patient enrollment|Pineal gland size was measured during routine MRI screening. Measurements were compared over time to quantify any change in size. Measurements were compared with standard pediatric norms to determine “prominence” or “mild enlargement” (subjective comparison).|||Participants|||Count of Participants
1285707|NCT00186888|Secondary|Number of Participants With Development of Pineal Cysts|The MRI reports from bilateral patients were reviewed and data abstracted regarding pineal gland measurement and information about pineal cysts. The number of participants with change in primary visual cortex function from diagnosis through 6 years after last patient enrollment is reported here.|At diagnosis through 6 years after last patient enrollment|A patient may be included in more than one category due to having more than one cyst.|||Participants|||Count of Participants
1285708|NCT00186888|Secondary|Assessment of School Readiness|The Bracken Basic Concepts Scale was used to assess school readiness. It is an examiner-administered measure that assesses per-academic skills including letter and number recognition, shapes, colors, and understanding of sizes and comparisons. Raw scores are converted into age-normed scaled scores (normative mean = 10, SD = 3) for the School Readiness Composite. Higher scores are indicative of stronger pre-academic skills, with scores from 7 to 13 within the Average range.|Patients were assessed at 5 years of age|All patients were included, regardless of treatment strata.|||units on a scale||Standard Deviation|Mean
1285709|NCT00186888|Secondary|Change in Parenting Stress Index (PSI)|The PSI is a commonly used measure of parenting stress. In 101 questions, the PSI delineates between stress as a function of child characteristics (e.g., adaptability, demandingness, mood; Child Domain) and stress as a function of parent characteristics (e.g., depression, sense of competence, social isolation; Parent Domain), as well as an overall stress score (Total Stress). Raw scores are calculated (normative means: Child Doman = 98.4; Parent Domain = 122.7; Total Stress Score = 221.1). This measure was given at all time points. Scores range from 131-320 for Total Stress, 69-188 for Parent Domain, and 50-145 for Child Domain, with higher scores indicative of greater stress (Total: >260; Parent: >153, Child: >122).|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.|||units on a scale||Standard Deviation|Mean
1285710|NCT00186888|Secondary|Change in Parent Report of Social-Emotional Factors|This outcome was measured using the Ages and Stages Questionnaire which is a parent-completed measure of a child's social-emotional functioning. Raw scores are calculated and compared to cut-off points by age (6 months = 45; 1 year = 48; 2 years = 50; 3 years = 59; 5 years =70). Higher scores are indicative of more problems with scores above the cut-off indicating significant concerns warranting additional follow-up. Possible scores range from 0 to 200+, depending on the number of items administered, which varies by the age of the child (19 to 33 items). However, the primary use of this tool is as a screener. Thus, typically, scores are interpreted as they compare to the identified cut-offs, with children who score above the cut-off referred for further evaluation. This measure was given at all time points.|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.|||units on a scale||Standard Deviation|Mean
1285711|NCT00186888|Secondary|Change in Relevant Daily Living Skills|The Adaptive Behavior composite was measured using the Vineland Scales of Adaptive Behavior (VABS) which is an examiner-administered semi-structured interview that assesses adaptive functioning from birth through adulthood. Subscales including motor skills, communication, socialization, and daily living skills combine into an overall adaptive behavior composite which is an age-normed standard score (normative mean = 100, SD = 15). This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range.|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.|||units on a scale||Standard Deviation|Mean
1285712|NCT00186888|Secondary|Change in Cognitive Functioning|The Early Learning Composite was assessed with Mullen Scales of Early Learning, a measure of developmental functioning appropriate for use with children from birth through age 5. It is an examiner-administered instrument that uses toys, games, pictures, and other objects to elicit information about a child's language, fine and gross motor skills, and overall early learning capabilities. Raw scores are converted to an age-normed standard score (normative mean = 100, SD = 15) for the overall Early Learning Composite. This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range.|Baseline (at study entry) and at ages 6 months, 1 year, 2 years, 3 years and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.|||units on a scale||Standard Deviation|Mean
1285713|NCT00186888|Secondary|Ocular Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification|"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma . The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately"|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. Participants with bilateral disease may have one eye in each category.|||probability|Number of Eyes|95% Confidence Interval|Number
1285714|NCT00186888|Secondary|Event-free Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification|"To describe the 5-year event-free survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately"|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. Participants with bilateral disease may have one eye in each category.|||probability|Eyes|95% Confidence Interval|Number
1285762|NCT00186056|Primary|Hamilton Depression Rating Scale|"Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).~Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline."|Baseline and Day 35 HAMD scores||||units on a scale||Standard Deviation|Mean
1285715|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification|"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability."|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed.For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. 51 eyes with IC grouping were analyzed. Participants with bilateral disease may have one eye in each category.|||probability|Eyes|95% Confidence Interval|Number
1285716|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification|"To describe the 5-year event-free survival of the eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability."|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. 51 eyes with IC grouping were analyzed. Participants with bilateral disease may have one eye in each category.|||probability|Number of Eyes|95% Confidence Interval|Number
1285717|NCT00186888|Secondary|Ocular Survival of Eyes of Stratum B Patients|"To estimate the 5-year ocular survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|The criteria considered eyes of all stratum B patients with R-E I-III (11 eyes in 11 patients).|||probability|Eyes|95% Confidence Interval|Number
1285718|NCT00186888|Secondary|Event-free Survival of Eyes of Stratum B Patients|"To estimate the 5-year event-free survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|The criteria considered eyes of all stratum B patients with R-E I-III (11 eyes in 11 patients).|||probability|Eyes|95% Confidence Interval|Number
1285719|NCT00186888|Secondary|Ocular Survival of Stratum A Patients|"To estimate the 5-year ocular survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|All 23 stratum A patients received VC treatment and focal therapy.|||probability||95% Confidence Interval|Number
1285720|NCT00186888|Secondary|Event-free Survival of Stratum A Patients|"To estimate the 5-year event-free survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|All 23 stratum A patients received VC treatment and focal therapy.|||probability||95% Confidence Interval|Number
1285721|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year ocular survival of the eye of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.||||||
1285722|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year event free survival of the eye of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.||||||
1286186|NCT00176878|Secondary|Number of Patients With Chronic Graft Versus Host Disease|Number of patients who exhibited chronic (normally occurs after 100 days) Graft Versus Host Disease at 2 years post transplant. Chronic graft-versus-host-disease, over its long-term course, can also cause damage to the connective tissue and exocrine glands.|2 years||||Participants|||Number
1285723|NCT00186888|Secondary|Ocular Survival of Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year ocular survival of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments.|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.||||||
1285724|NCT00186888|Secondary|Event-free Survival of Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year event free survival of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments.|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.||||||
1285725|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum B Patients Responding to Window Treatment|"To estimate the 5-year ocular survival of eye of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival of eye will be defined per eye as the time interval from date on study to date of enucleation or date of last follow-up. Ocular survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival."|From date on-study to an event or last follow-up|Of the 52 eyes (26 evaluable patients), 2 eyes (2 patients) were removed from analysis as they were not responsive to window therapy. In both cases, the contralateral eye was included in the analysis. One patient with upfront enucleation had only one eye for analysis. Eleven eyes were R-E Group I-III and were excluded. Total: 38 eyes for analysis.|||probability|Eyes|95% Confidence Interval|Number
1285726|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum B Patients Responding to Window Treatment|"To estimate the 5-year event-free survival (EFS) of eyes of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year EFS."|From date on-study to an event or last follow-up|Of the 52 eyes (26 evaluable patients), 2 eyes (2 patients) were removed from analysis as they were not responsive to window therapy. In both cases, the contralateral eye was included in the analysis. One patient with upfront enucleation had only one eye for analysis. Eleven eyes were R-E Group I-III and were excluded. Total: 38 eyes for analysis.|||probability|Eyes|95% Confidence Interval|Number
1285727|NCT00186888|Secondary|Ocular Survival of Stratum B Patients Responding to Window Treatment|"To estimate the 5-year ocular survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival"|From date on-study to an event or last follow-up|From the total of 27 eligible patients in stratum B, 3 patients were not responding to the window therapy; 1 withdrew the consent and was taken off the study, and 2 developed disease progression. Thus, the Kaplan and Meier estimate of ocular survival was calculated for the remaining 24 patients.|||probability||95% Confidence Interval|Number
1285728|NCT00186888|Secondary|Event-free Survival of Stratum B Patients Responding to Window Treatment|"To estimate the 5-year event-free (EFS) survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|Of the total 27 eligible patients in stratum B, 3 patients were not responding to the window therapy; 1 withdrew the consent and was taken off the study, and 2 developed disease progression. Kaplan and Meier estimate of ocular survival was calculated for the remaining 24 patients.|||probability||95% Confidence Interval|Number
1285729|NCT00186888|Secondary|Relationship Between Topotecan Clearance (CL) and ABCG2/B1 Genotype in Stratum B Participants.|Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol.|Courses 1, 2, 5, and 8|"Of the 107 participants enrolled in the overall study, analysis was performed for 19 participants who were enrolled on Stratum B AND who had results for both topotecan clearance and pharmacogenetic studies.~Only wild-type was present in BCRP 15994, therefore, statistical analysis was not done for these alleles."|||Liters/hour/m^2||95% Confidence Interval|Median
1285779|NCT00185731|Primary|Tumor Apoptosis|Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment|1 year|24 participants had tumors sampled for primary endpoint as per protocol. However, 1 withdrew, and only 22 of remaining participants had adequate tumor samples for analysis of apoptosis at baseline and at subsequent time points.|||Participants|||Count of Participants
1285730|NCT00186888|Secondary|Relationship Between Topotecan Clearance (CL) and CYP3A4/5 Genotype in Stratum B Participants.|Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol.|Courses 1, 2, 5, and 8|"Of the 107 participants enrolled in the overall study, analysis was performed for 19 participants who were enrolled on Stratum B AND who had results for both topotecan clearance and pharmacogenetic studies.~Only wild-type was present in CYP3A5*6, therefore, statistical analysis was not done for these alleles."|||Liters/hour/m^2||95% Confidence Interval|Median
1285731|NCT00186888|Secondary|Stratum B Response Rate of Early Stage Eyes to Window Therapy|To estimate the proportion of early stage eyes defined as Reese-Ellsworth Group I, II, or III eyes, that responded to 2 courses of window therapy which consisted of vincristine and topotecan|Six weeks post window therapy.|Among the 27 stratum B patients with 54 eyes with retinoblastoma, 12 eyes were early stage (Reese-Ellsworth group I, II, or III). The remaining 42 eyes were advanced stage and were not included in this analysis.|||Participants|||Number
1285732|NCT00186888|Primary|Stratum B Response to Window Therapy|The primary outcome is to estimate the proportion of stratum B patients responding to 2 courses of window therapy consisting of vincristine and topotecan. Complete Response is the complete regression of all apparent tumor masses in the funduscopic examination and by MRI and ultrasound (US). Partial Response is defined as greater than 50% (but less than 100%) reduction of the tumor masses in the funduscopic examination and by US and MRI, without the appearance of any new lesions. The response must persist for at least 4 weeks. Stratum A and C did not receive window therapy.|Six weeks post window therapy|The primary objective related to stratum B patients only, as these were the patients who were given window therapy consisting of 2 courses of vincristine and topotecan. Of the 27 stratum B patients enrolled, all were included in the analysis of the primary objective.|||Participants|||Number
1285733|NCT00186875|Other Pre-specified|Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)|The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block B is defined as the proportion of MRD positives.|End of Block B therapy (Day 19)|Protocol information for the comparison group of TOTXV Participants, including Participant Flow, Baseline Characteristics, and Adverse Events, is available on ClinicalTrials.gov under registration ID NCT00137111.|||Participants|||Count of Participants
1285734|NCT00186875|Other Pre-specified|Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)|The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block C is defined as the proportion of MRD positives.|End of Block Block C therapy (Day 46)|Protocol information for the comparison group of TOTXV Participants, including Participant Flow, Baseline Characteristics, and Adverse Events, is available on ClinicalTrials.gov under registration ID NCT00137111.|||Participants|||Count of Participants
1285735|NCT00186875|Primary|Overall Survival (OS)|OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate. The probability of survival at 5 years after diagnosis is given.|2 years after last patient completes therapy (approximately 4 years after enrollment)||||probability||Standard Deviation|Mean
1285736|NCT00186875|Primary|Response Rate|"The response rate is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as <5% blasts in bone marrow by morphology."|End of re-induction Block C (approximately 1 month after the start of therapy)|Response is defined as morphological complete remission after re-induction Block C. Participants who begin re-induction phase but fail to reach the end of Block C for whatever reason will be regarded as an induction failure.|||proportion of participants|||Number
1285737|NCT00186628|Secondary|Overall Survival||4 years|35 total participants were analyzed. No data is available for the withdrawn participant.|||Percentage of participants by disease||95% Confidence Interval|Number
1285738|NCT00186628|Secondary|Mortality|Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse.|Day 100 and 1 year|35 total participants were analyzed. No data is available for the withdrawn participant.|||Participants|||Number
1285739|NCT00186628|Secondary|Incidence of Relapse|Subjects who Relapsed following after Allogeneic HSCT|4 years|35 total participants were analyzed. No data is available for the withdrawn participant.|||Participants|||Count of Participants
1285740|NCT00186628|Primary|Chronic Graft-vs-Host Disease (cGvHD)|The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955)|4 years|35 total participants were analyzed. No data is available for the withdrawn participant.|||percentage of participants||95% Confidence Interval|Number
1285741|NCT00186537|Primary|Pre- and Post-Intervention HDL Cholesterol Levels|Compare the change in mean HDL Cholesterol levels between groups after the interventions|Baseline, 12 weeks|HDL Cholesterol|||mg/dL||Standard Deviation|Mean
1285742|NCT00186537|Primary|Pre- and Post-Intervention LDL Cholesterol Levels|Compare the change in mean LDL Cholesterol levels between groups after the interventions|Baseline, 12 weeks|LDL cholesterol|||mg/dL||Standard Deviation|Mean
1285743|NCT00186537|Primary|Pre- and Post-Intervention Triglyceride Levels|Compare the change in mean triglyceride levels between groups after the interventions|Baseline, 12 weeks|Triglycerides|||mg/dL||Standard Deviation|Mean
1285763|NCT00186043|Primary|Percentage of Participants With Clinical Global Impression for Bipolar Disorders Overall Severity Remission (Score <=2 at Week 8)|"0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|Week 8|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.|||percentage of participants|||Number
1285744|NCT00186485|Secondary|Clinical Global Impression - Severity; Baseline to End of Week 4|The Clinical Global Impression of Severity (CGI-S) is a measure of depression severity and disability based on the clinicians overall impression of the severity of depression based on the patients response to open ended questions and self report of the presence and severity of the symptoms and level of disability found in depression. The CGI-S assesses the severity of illness (depression) and is scored from 1 (well, not at all ill) to 7 (among the most severely ill patients); a decrease in the CGI-S score reflects a reduction of the symptoms and disability due to depression. The scores are from Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward|||units on a scale||Standard Deviation|Mean
1285745|NCT00186485|Secondary|Beck Depression Inventory Score; Baseline to End of Week 4|The Beck Depression Inventory Scale (BDI) measures the severity of depression based on the patients response to 21 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 3 (most severe); total scores range from 0 (no depressive symptoms), to 63 (very severe depression). A decrease in the score reflects a reduction of the severity of depression.The scores are from Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward|||units on a scale||Standard Deviation|Mean
1285746|NCT00186485|Primary|Hamilton Depression Rating Scale (HDRS) -17 Item; Baseline to End of Week 4|The HDRS - 17 is a scale that measures the severity of depression based on the patients response to 17 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 4 (most severe); total scores range from 0 (no depressive symptoms), to 68 (very severe depression). A decrease in the HDRS score reflects a reduction in depression severity.The scores are Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward|||units on a scale||Standard Deviation|Mean
1285747|NCT00186446|Primary|Can Depression and Smoking Cessation be Treated Simultaneously|This was measured by the drop out rate during the study.|Dropouts over course of study|Number dropped out of the study|||Participants|||Count of Participants
1285748|NCT00186446|Primary|Cessation of Smoking|Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.|Week 10|Carbon monoxide levels available on 8 subjects at week 10.|||Participants|||Count of Participants
1285749|NCT00186446|Primary|Hamilton Depression Scale Score|Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.|baseline to week 10|9 patients did not complete the study and we used last observation carried forward|||percentage of change in depression||Standard Deviation|Mean
1285750|NCT00186186|Secondary|Response to the Divalproex-ER in Acute Bipolar 2 Depression.|A reduction greater than or equal to 50% in MADRS total score from baseline to the endpoint.|7 weeks||||participants|||Number
1285751|NCT00186186|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|"The Montgomery–Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.~Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60.~Usual cutoff points are:~0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression."|Baseline, 7 weeks||||units on a scale||Standard Deviation|Mean
1285752|NCT00186121|Secondary|Serious Adverse Events|The toxicity of the treatment regimen of goserelin followed by anastrozole is estimated by the rate of Serious Adverse Events (SAEs) that occurred during the course of the study.|6 months||||Serious Adverse Events (SAEs)|||Number
1285753|NCT00186121|Secondary|Estradiol Suppression|Plasma estradiol determinations were performed at baseline, 1 month, 3 months, and 6 months using the Coat-A-Count Estradiol competitive binding assay system, which has a calibrated range for estradiol of 20 to 3,600 pg/mL with an analytical sensitivity of 10 pg/mL.|6 months||||pg/mL estradiol||Standard Deviation|Mean
1285754|NCT00186121|Secondary|Overall Survival (OS)|Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole.|up to 63 months||||months||Full Range|Median
1285755|NCT00186121|Secondary|Time-to-Progression (TTP)|"Time-to-progression (TTP) was assessed as the median observed in the participant group.~Progression of disease was considered, per protocol, to be ≤ 25% increase in the area of any malignant lesion greater than 2 square cm, or ≤ 25% increase in the sum of the products of the longest perpendicular diameters of individual lesions in a given organ, when compared to baseline values or after therapeutic response."|up to 63 months||||months||Full Range|Median
1285756|NCT00186121|Secondary|Response Rates|"The numbers of participants with metastatic breast cancer experiencing Complete Response (CR); Partial Response (PR); or Stable Disease (SD) after treatment with goserelin followed by anastrozole are reported.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~SD = No significant change in measurable or evaluable disease for at least 4 weeks.~All measurements by ruler or calipers."|6 months||||Participants|||Count of Participants
1285757|NCT00186121|Secondary|Clinical Benefit Rate|"The overall clinical benefit rate of goserelin followed by anastrozole was evaluated, as determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~SD = No significant change in measurable or evaluable disease for at least 4 weeks.~All measurements by ruler or calipers."|6 months||||percentage of participants||95% Confidence Interval|Number
1285758|NCT00186121|Primary|Objective Response Rate (ORR)|"ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~All measurements by ruler or calipers."|3 months||||percentage of participants||95% Confidence Interval|Number
1285764|NCT00186043|Secondary|Percentage of Participants With 50% Improvement From Baseline in Both Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) Scores|MADRS assesses change from baseline to endpoint. Higher score indicates more severe depression; each item yields a score of 0 to 6. Overall score ranges: 0 to 60. Questions following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Cutoff points:0 to 6– normal/symptom absent; 7 to 19– mild depression; 20 to 34– moderate depression; >34– severe depression. YMRS:a 11-item clinician-admin instrument assesses severity of mania. Symptoms rated: Elevated mood, Increased motor activity/energy, Sexual interest, Sleep, irritability, Speech, language/thought disorder, Content, Disruptive/aggressive behavior, Appearance, Insight. Each composed of five explicitly defined levels of severity. Severity ratings based on patient's subjective report of clinical condition during past 48 hours and clinician's observations.|Baseline and 8 weeks|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.|||percentage of participants|||Number
1285765|NCT00186043|Primary|Percentage of Participants With >=50% Improvement From Baseline in Clinical Global Impression for Bipolar Disorders Overall Severity|"0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|Baseline and 8 weeks|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.|||percentage of participants|||Number
1285766|NCT00186017|Secondary|Mean Change in Hamilton Anxiety Rating Scales (HAM-A)|"The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A does not provide any standardized probe questions. Despite this,the reported levels of interrater reliability for the scale appear to be acceptable.~Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe."|Baseline, 1 Week||||units on a scale||Standard Deviation|Mean
1285767|NCT00186017|Secondary|Mean Change in MADRS After 1 Week of Treatment.|Montgomery-Asberg Depression Rating Scales (MADRS) is a multi-item clinician tool assessing depression. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.|Baseline, 1 week||||units on a scale||Standard Deviation|Mean
1285768|NCT00186017|Secondary|Mean Change in YMRS After 1 Week of Treatment|"The Young Mania Rating Scale (YMRS) scale has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Responses to each item are summed with a higher score indicating more mania symptoms endorsed.~Scale:0-60 0=Good 60=Bad"|Baseline, 1 week||||units on a scale||Standard Deviation|Mean
1285769|NCT00186017|Primary|Mean Change in CGI-BP-OS After 1 Week of Treatment|The Clinical Global Impression - bipolar version – overall severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not ill; 2, minimally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, very severely ill|Baseline, 1 Week||||units on a scale||Standard Deviation|Mean
1285770|NCT00185965|Primary|Objective Response Rate (ORR)|Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)|12 weeks||||percentage of treated subjects|||Number
1285771|NCT00185900|Secondary|Composite Neonatal Morbidity|Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.|From delivery until discharge from the hospital, up to 30 days of age|Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed.|||Participants|||Count of Participants
1285772|NCT00185900|Secondary|Serious Maternal Adverse Effect|A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.|From study enrollment until discharge from delivery hospital, up to 30 days after delivery.||||Participants|||Count of Participants
1285773|NCT00185900|Secondary|Neonatal Birth Weight|Presented as grams|Until delivery, up to 42 weeks of gestation|Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed|||grams||Standard Deviation|Mean
1285774|NCT00185900|Secondary|Gestational Age at Delivery|Presented as weeks|Until delivery, up to 42 weeks of gestation||||weeks||Standard Deviation|Mean
1285775|NCT00185900|Secondary|Time to Uterine Quiescence|Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.|Until delivery, up to 42 weeks of gestation||||hours||Standard Deviation|Mean
1285776|NCT00185900|Primary|Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence|Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.|48 hours after administration of study medication.||||Participants|||Count of Participants
1285777|NCT00185731|Secondary|Atorvastatin Toxicity|Assessed as the number of study participants with atorvastatin-related serious adverse events (SAEs).|1 year|All study participants who received atorvastatin|||Participants|||Count of Participants
1285778|NCT00185731|Secondary|Correlation of Tumor Apoptosis to Clinical Response|The validity of tumor apoptosis as a biologic endpoint was assessed by correlation to clinical response. A correlation substantially less than 1 is interpreted as a poor correlation, while a correlation near +1 or -1 is interpreted as a strong correlation.|1 year|24 participants had tumors sampled for primary endpoint as per protocol. However, 1 withdrew and 1 had an inadequate tumor samples for analysis, leaving only 22 remaining participants for analysis of apoptosis at baseline and at subsequent time points.|||Pearson Correlation Coefficient|||Number
1285932|NCT00183339|Secondary|Rate of Attrition|The percentage of participants who discontinued treatment prior to completion of the 12 month study|Measured at Month 12||||percent of group that discontinued early|||Number
1285780|NCT00185692|Secondary|Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant|GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant.|90 days||||Participants|||Count of Participants
1285781|NCT00185692|Primary|Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning|number achieving donor cell engraftment (>95%) by day 90 after transplant.|100 days||||Participants|||Count of Participants
1285782|NCT00185679|Secondary|Platelet Recovery|Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions|40 days||||participants|||Number
1285783|NCT00185679|Secondary|Acute GvHD (Grade II-IV)|Number of subjects with acute GvHD (grade II-IV) within 100 days post-transplant, per the Consensus Conference on Acute GvHD Grading (Przepiorka D, et al. Bone Marrow Transplantation. 1995. 15:825-828).|within 100 days post-transplant||||participants|||Number
1285784|NCT00185679|Primary|Neutrophil Engraftment|Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC > 0.5x10e9/L|30 days post-transplant||||participants|||Number
1285785|NCT00185640|Secondary|Transplant-related Mortality|Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant.|1 year||||percentage of participants|||Number
1285786|NCT00185640|Secondary|Event-free Survival (EFS)|Reports the proportion of subjects who neither died due to any cause nor experienced relapse.|3 and 5 years||||percentage of participants|||Number
1285787|NCT00185640|Secondary|Overall Survival (OS)||3 and 5 years||||percentage of participants|||Number
1285788|NCT00185640|Secondary|Incidence of Relapse|Reports the overall rate of disease relapse, occurring any time within 3 years after transplant|3 years||||percentage of participants|||Number
1285789|NCT00185640|Secondary|Acute Graft vs Host Disease (GvHD), All Evaluable|"The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.~Skin manifestations Skin Stages~0: No rash~1: Maculopapular (MP) rash <25% of body surface area~2: MP rash on 25-50% of body surface area~3: Generalized erythroderma (ED)~4: Generalized ED with bullous formation and desquamation~Liver Stages (Bilirubin in mg/dL)~0: <2~1: 2-3~2: 3.01-6~3: 6.01-15.0~4: >15~Gastrointestinal (GI) Stages (diarrhea)~0: None or < 500 mL/day~1: 500-999 mL/day~2: 1000-1499 mL/day~3: >1500 mL/day~4: Severe abdominal pain, with or without ileus~Glucksberg Overall grade~Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%.~Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80~Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60~Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40"|100 days post-transplant||||percentage of participants|||Number
1285790|NCT00185640|Primary|Acute Graft vs Host Disease (GvHD)|"The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.~Skin manifestations Skin Stages~0: No rash~1: Maculopapular (MP) rash <25% of body surface area~2: MP rash on 25-50% of body surface area~3: Generalized erythroderma (ED)~4: Generalized ED with bullous formation and desquamation~Liver Stages (Bilirubin in mg/dL)~0: <2~1: 2-3~2: 3.01-6~3: 6.01-15.0~4: >15~Gastrointestinal (GI) Stages (diarrhea)~0: None or < 500 mL/day~1: 500-999 mL/day~2: 1000-1499 mL/day~3: >1500 mL/day~4: Severe abdominal pain, with or without ileus~Glucksberg Overall grade~Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%.~Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80~Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60~Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40"|100 days post-transplant|Reports the incidence of Grades 2 to 4 acute GvHD, as observed for the initial 37 participants treated on this study, who constitute the Primary Analysis for the study. See linked citation Lowsky, et al. NEJM. 29Sep2005;353(13)1321-1331.|||percentage of participants|||Number
1285791|NCT00185614|Secondary|Chronic Graft-vs-Host-Disease (cGvHD)|"Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as Extensive cGvHD; cGvHD, Not Extensive; or No cGvHD, as determined by investigator judgement (no protocol-specified criteria)."|3 years|Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT.|||Participants|||Count of Participants
1285792|NCT00185614|Secondary|Acute Graft-vs-Host-Disease (aGvHD)|Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.|6 months|Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT, as determined by investigator judgement (no protocol-specified criteria).|||Participants|||Count of Participants
1285793|NCT00185614|Secondary|Overall Survival (OS)|Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.|3 years|"The outcome data are reported as the number of participants who could be documented as remaining alive through 3 years from the date of the last transplant, for the Auto-HCT only population, the Auto-HCT then Allo-HCT population, and the overall study population (ie, Auto-HCT only plus +Auto-HCT then Allo-HCT)."|||participants|||Number
1285794|NCT00185614|Secondary|Relapse Rate|Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase).|3 years|The outcome data are reported as the number of participants who relapse per criteria within 3 years.|||participants|||Number
1285795|NCT00185614|Primary|Event-free Survival (EFS)|"Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. Event was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years."|3 years|"The outcome data are reported as the number of participants who do not experience an EFS event within 3 years from the date of the last transplant, for the Auto-HCT only population, the Auto-HCT then Allo-HCT population, and the overall study population (ie, Auto-HCT only plus +Auto-HCT then Allo-HCT)."|||Participants|||Count of Participants
1285956|NCT00182767|Secondary|Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II)||Up to 2 years||||participants|||Number
1285796|NCT00185588|Secondary|Time-to-Progression, Evaluable Patients|Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.|12 months|"Evaluable subset of subjects that terminated from the study due to disease progression (endpoint).~No participants were analyzed in the Stage 1 Dose Exploration 2 - Gemcitabine 850 + Vatalanib 2 x 250 / 2 x 500 group because no evaluable participants progressed within 12 months."|||months||Full Range|Median
1285797|NCT00185588|Primary|Time-to-Treatment Failure (Intent-To-Treat Analysis)|"For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death.~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)."|12 months||||months||Full Range|Median
1285798|NCT00185458|Secondary|Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285799|NCT00185458|Secondary|Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285800|NCT00185458|Secondary|Climacteric Symptom 6: Breast Tension (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285801|NCT00185458|Secondary|Climacteric Symptom 5: Irritability (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285802|NCT00185458|Secondary|Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285803|NCT00185458|Secondary|Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285804|NCT00185458|Secondary|Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285805|NCT00185458|Secondary|Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285806|NCT00185458|Secondary|Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285807|NCT00185458|Secondary|Progestogenic Symptom 5: Edema (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285808|NCT00185458|Secondary|Progestogenic Symptom 4: Nausea (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285957|NCT00182767|Primary|Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I)|Dose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities|28 days||||participants|||Number
1285809|NCT00185458|Secondary|Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285810|NCT00185458|Secondary|Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285811|NCT00185458|Secondary|Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285812|NCT00185458|Secondary|Continuation Rates|Percentage of subjects continuing in the study at the given time points.|At entry, at 2 years, at 4 years|ITT. Kaplan-Meier estimator given.|||Percentage of participants continuing|||Number
1285813|NCT00185458|Secondary|Assessment of QOL as Measured by Women's Health Questionnaire|Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
1285814|NCT00185458|Primary|Percentage of Participants With Successful Treatment|"Definition of successful treatment:~Completion of HRT phase, and~Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and~The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT"|Last 90 days in Contraception Phase and first 360 days in HRT Phase|ITT; all subjects eligible for the HRT|||Percentage of participants with success|||Number
1285815|NCT00185458|Primary|Number of Spotting Days|Measured by using Subject Diaries (Subject Reported Data)|Last 90 days in Contraception Phase and first 360 days in HRT Phase|ITT; all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||Spotting days||Inter-Quartile Range|Median
1285816|NCT00185458|Primary|Number of Bleeding Days|Measured by using Subject Diaries (Subject Reported Data)|Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase|Intention to treat population (ITT); all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||Bleeding days||Inter-Quartile Range|Median
1285817|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 12|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 991 to day 1080|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
1285818|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 4|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 271 to day 360|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
1285819|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 3|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 181 to day 270|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
1285820|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 2|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 91 to day 180|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
1285821|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 1|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 1 to day 90|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
1285822|NCT00185380|Secondary|Number of Subjects With Total or Partial Expulsions|The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.|Up to 3 years|The analysis was performed on the FAS (all subjects who had an IUS inserted).|||participants|||Number
1285823|NCT00185380|Primary|Pearl Index|The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.|Up to 3 years|All randomized women with a successful insertion were analyzed according to the treatment actually received and were included in the FAS, which was the set used for all safety and efficacy analyses. The PPS was identical to the FAS.|||Number per 100 women years||95% Confidence Interval|Median
1285972|NCT00182637|Secondary|Time to Progression||2 years|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.||||||
1285824|NCT00185211|Secondary|MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60|Two-timepoint percentage brain volume change was estimated with Structural Image Evaluation, using Normalisation, of Atrophy (SIENA) software. The measurements describe the percentage change from screening in brain volume at month 60.|60 months after start of treatment|The analysis followed the ITT principle. Not all patients in the full analysis set completed the follow-up study or had MRI scan readings at month 60 available. There were several missing values in both treatment arms regarding the percentage brain volume change.|||Percentage of brain volume||Inter-Quartile Range|Median
1285825|NCT00185211|Secondary|MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60|Absolute change of volume of black holes from screening MRI to month 60 was calculated as volume of black holes at month 60 minus volume of black holes at screening.|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MRI scan readings at month 60 available.|||cubic millimeter||Inter-Quartile Range|Median
1285826|NCT00185211|Secondary|MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60|Absolute change of T2 lesion volume from screening MRI to month 60 was calculated as T2 lesion volume at month 60 minus T2 lesion volume at screening.|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MRI scan readings at month 60 available.|||cubic millimeter||Inter-Quartile Range|Median
1285827|NCT00185211|Secondary|MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60|Newly active lesions are defined as displaying either new Gadolinium (Gd)-enhancement on T1-weighted scans or non-enhancement on T1-weighted scan but new on T2-weighted scan. The numbers of newly active lesions on yearly MRI scans were summed up to the cumulative number.|up to 60 months after start of treatment|The analysis followed the ITT principle. Not all patients in the full analysis set completed the follow-up study or had MRI scan readings at month 60 available.|||cumulative number of lesions||Inter-Quartile Range|Median
1285828|NCT00185211|Secondary|Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60|"The MSFC score consists of three sub-tests (Timed-25-Foot-Walk, 9-Hole-Peg-Test, 3 Paced Auditory Serial Addition Test [PASAT]). Standardized results (Z-scores) of the sub-tests and the overall MSFC Z-score as an average of the three Z-scores were derived using baseline data pooled over both treatment arms as reference population. Higher Z-scores reflect a better neurological status."|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MSFC results at month 60 available.|||Z-scores||Inter-Quartile Range|Median
1285829|NCT00185211|Secondary|Relapse-based Efficacy Domain (Supportive): Annualized Relapse Rate|The annualized relapse rate is defined as total number of relapses up to month 60 divided by the total observation time (last clinical visit minus first day of study treatment administration plus 1 of all participants) in years.|up to 60 months after start of treatment|The analysis followed the ITT principle. For each treatment arm, the relapse rate is defined as total number of relapses up to month 60 divided by the total observation time in years.|||number of relapses per patient and year||95% Confidence Interval|Mean
1285830|NCT00185211|Secondary|Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses|A relapse was defined as the appearance of a new neurological abnormality or the reappearance of a neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The time to the onset of recurrent relapses was determined for each subject according to the counting process representation for recurrent events. Time to a relapse was right-censored if a relapse-risk period ended without relapse. Based on the Andersen-Gill model the hazard ratio for recurrent relapses was estimated. Annualized relapse rates are provided as another outcome measure.|up to 60 months after start of treatment|The analysis followed the Intention-To-Treat (ITT) principle. The hazard for recurrent relapses was modelled by an extension of the Cox Proportional Hazards (PH) regression model (Andersen-Gill Model).|||Ratio|||Number
1285831|NCT00185211|Secondary|Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria|MS according to the criteria by McDonald was reached if, in addition to the single clinical demyelinating event, both dissemination in space and dissemination in time were established by MRI-criteria or a new relapse. Time to McDonald MS is the difference of date of McDonald MS to the date of Day 1 + 1. For subjects without McDonald MS, time to McDonald MS is the difference from the maximum (date of last magnetic resonance imaging scan, date of last clinical visit) to the date of Day 1 + 1 (right-censored observation).|up to 60 months after start of treatment|The analysis followed the ITT principle. After five years, in the initial placebo arm 151 participants and in the initial IFNB-1b arm 224 participants had reached McDonald MS diagnosis.|||months||95% Confidence Interval|Median
1285832|NCT00185211|Primary|Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60|As an index of health related quality of life in people diagnosed with MS, the FAMS Trial Outcome Index covers overall physical health (sum of sub-scale scores Mobility, Symptoms, Thinking/Fatigue, Additional Concerns) with a score range from 0 to 148. A higher score reflects a higher overall physical health as reported by patients.|60 months after start of treatment|The analysis followed the ITT principle. Not all patients who completed the follow-up study could be included at month 60 as subject to copyright constraints and to the availability of validated language versions, FAMS assessments could not be conducted in all patients.|||units on a scale||Inter-Quartile Range|Median
1285833|NCT00185211|Primary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time|"EDSS progression was defined as an increase in the expanded disability status scale (EDSS) of 1.0 point compared to the lowest EDSS score obtained during the screening or baseline visit, if this score was &lt;= 5.5. A confirmed EDSS progression status was defined as an EDSS progression observed at two consecutive scheduled visits at least 140 days apart from each other. The EDSS scale is a method of quantifying disability in multiple sclerosis in eight functional systems and values vary between 0=normal neurological examination and 10=death due to MS measured in half-points on a scale."|up to 60 months after start of treatment|The analysis followed the ITT principle. The 25%-percentile for time to confirmed EDSS progression was 908 days in the initial placebo arm but was not estimable in the initial IFNB-1b arm. After five years, in the initial placebo arm 47 participants and in the initial IFNB-1b arm 65 participants had reached confirmed EDSS progression.|||percentage of particip. with EDSS progr.|||Number
1285834|NCT00185211|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time|"CDMS could be reached due to a qualifying relapse or sustained progression of 1.5 points on the expanded disability status scale (EDSS) as compared to the lowest EDSS obtained during screening or Day 1. The validity of CDMS diagnoses was confirmed by a central committee. The EDSS scale quantifies disability in MS in 8 functional systems, values vary between 0=normal neurological examination and 10=death due to MS measured in half-points on an ordinal scale. Time to CDMS = date of CDMS - date of Day 1 + 1 or time to CDMS = date of last clinical visit - date of Day 1 + 1 (right-censored)"|up to 60 months after start of treatment|The analysis followed the intention to treat (ITT) principle. After five years, in the initial placebo arm 94 participants and in the initial IFNB-1b arm 124 participants had reached CDMS diagnosis.|||cum. percentage of particip. with CDMS|||Number
1285835|NCT00184717|Secondary|Adverse Events - Subjects Received NN220 Treatment for 4 Years|Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly|Weeks 0-208|Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Subjects|||Number
1285836|NCT00184717|Secondary|Adverse Events - Subjects Received NN220 Treatment for 5 Years|Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly|Weeks 0-260|Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Subjects|||Number
1285837|NCT00184717|Secondary|Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years|Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52*i weeks – Bone age at 52*(i-1) weeks, i=1, 2, ….|Week 0, week 208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||years||Standard Deviation|Mean
1285838|NCT00184717|Secondary|Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years|Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52*i weeks – Bone age at 52*(i-1) weeks, i=1, 2, ….|Week 0, week 260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||years||Standard Deviation|Mean
1285839|NCT00184717|Secondary|Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years|Yearly Height velocity SDS for chronological age were summarised and graphically presented|Weeks 0-208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Standard Deviation Score (SDS)||Standard Deviation|Mean
1285840|NCT00184717|Secondary|Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years|Yearly Height velocity SDS for chronological age were summarised and graphically presented|Weeks 0-260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Standard Deviation Score (SDS)||Standard Deviation|Mean
1285841|NCT00184717|Primary|Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years|Height SDS for chronological age were derived as follow; {Height – mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit|Week 0, week 208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
1285842|NCT00184717|Primary|Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years|Height SDS for chronological age were derived as follow; {Height – mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit|Week 0, week 260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
1285843|NCT00184600|Secondary|Number of Participants Having an 'Other' Adverse Event||Up to month 37 (36 months of treatment plus 1 month follow-up)|Safety population consisting of all randomised participants exposed to at least one dose of trial drug(s).|||participants|||Number
1285844|NCT00184600|Secondary|Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months|The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||units on a scale||95% Confidence Interval|Mean
1285845|NCT00184600|Secondary|Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months|The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||units on a scale||95% Confidence Interval|Mean
1285846|NCT00184600|Secondary|Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months|For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.|Baseline, month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||mg/dL||Standard Deviation|Mean
1285847|NCT00184600|Secondary|Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months|For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.|Baseline, month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||mg/dL||Standard Deviation|Mean
1285848|NCT00184600|Secondary|Change From Baseline in Body Weight at Month 36||Week 0 (baseline), month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||kilograms||Standard Deviation|Mean
1285849|NCT00184600|Secondary|Change From Baseline in Body Weight at Month 12||Week 0 (baseline), month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||kilogram||Standard Deviation|Mean
1285850|NCT00184600|Secondary|Percentage of Participants Who Required A Second Insulin Therapy by Month 36|Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage of participants|||Number
1285851|NCT00184600|Secondary|Percentage of Participants Who Required A Second Insulin Therapy by Month 12|Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage of participants|||Number
1285852|NCT00184600|Secondary|Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%|Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||hypoglycaemic events/participant/year||Inter-Quartile Range|Median
1285973|NCT00182637|Primary|Overall Response Rate After 2 Courses of Treatment||2 months|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.||||||
1285853|NCT00184600|Secondary|Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%|Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||hypoglycaemic events/participant/year||Inter-Quartile Range|Median
1285854|NCT00184600|Secondary|Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%|Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage of participants|||Number
1285855|NCT00184600|Secondary|Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%|Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage of participants|||Number
1285856|NCT00184600|Primary|HbA1c (Glycosylated Haemoglobin) at Month 36|HbA1c values offer evidence of the efficacy and durability of the insulin regimens.|Baseline, Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage (%) of total haemoglobin||Standard Deviation|Mean
1285857|NCT00184600|Primary|HbA1c (Glycosylated Haemoglobin) at Month 12|HbA1c values offer evidence of the efficacy and durability of the insulin regimens.|Baseline, Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage (%) of total haemoglobin||Standard Deviation|Mean
1285858|NCT00184548|Secondary|Number of Units of All Allogeneic Transfusions From Time of First Dose|The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set, including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Units of allogeneic transfusions||Standard Deviation|Mean
1285859|NCT00184548|Secondary|Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury|The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Participants|||Number
1285860|NCT00184548|Secondary|Number of Units of Transfused Red Blood Cells From Time of First Dose|The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Units of transfused red blood cells||Standard Deviation|Mean
1285861|NCT00184548|Secondary|Time to Death From Time of First Dose|The time of first dose refers to the time of the first dose of rFVIIa or placebo.|from day 0 to day 30|There is no measure summary for time to event type of endpoint as this would be a Kaplan-Meier graph.||||||
1285862|NCT00184548|Secondary|Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention|The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.|from day 0 to day 30|Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Days||Standard Deviation|Mean
1285863|NCT00184548|Primary|Morbidity|Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.|from day 0 to day 30|Blunt trauma patient population: According to protocol, morbidity is not part of the primary endpoint since non-inferiority test of mortality was not passed. Penetrating Trauma patient population: No analysis done due to low statistical power.||||||
1285864|NCT00184548|Primary|Mortality|Number of participants to die from day 0 to day 30 from all causes.|from day 0 to 30|Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Patients who discontinued (withdrawn or lost to follow up) before day 30 were excluded from analyses. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Participants|||Number
1286237|NCT00176644|Secondary|To Evaluate Measurable Disease Response in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).||||||
1285865|NCT00184093|Secondary|Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)|"Participants who complete the 6 weeks of chemotherapy and radiation or who experience dose limiting toxicity or who progress at any time prior to completion of the 6 weeks of chemotherapy and radiation will be evaluable for response.~Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of nonevaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable, and nonevaluable lesions and sites must be assessed using the same technique as baseline.~Partial response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline."|Baseline to response (up to 24 months)||||Participants|||Count of Participants
1285866|NCT00184093|Primary|Toxicity (Number of Participants With Serious Adverse Events)|Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)|Every 3 weeks from start of study until 30 days after the last dose of treatment||||Participants|||Count of Participants
1285867|NCT00184054|Secondary|Number of Participants With Severe (Grades 3-5) Adverse Events|Patients who received any amount of ATO plus Ascorbic Acid are included in the safety analyses.|Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy)||||Participants|||Number
1285868|NCT00184054|Primary|Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi)|Complete Remission (CR): ANC >=1000/mcl, Platelet count >=100,000/mcl, Bone marrow <5% blasts. Complete Remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Patients who failed to achieve CR or CRi after two cycles were considered treatment failures. Patients who did not complete at least two cycles were not evaluated for response.|Up to 1 year|All subjects who received at least 2 cycles of treatment as part of this study are included in the analysis of response.|||participants|||Number
1285869|NCT00184028|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|At end of every cycle|All participants who started treatment|||Participants|||Number
1285870|NCT00184028|Primary|Tumor Response|"All eligible patients who received the first dose of Taxotere will be included in the analysis.~Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease.~Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 months after the last subject enrolled has gone off study||||Participants|||Number
1285871|NCT00184002|Secondary|Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability|Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.|At end of every cycle||||Participants|||Count of Participants
1285872|NCT00184002|Primary|Percentage of Patients With Complete Response to the Combination Chemotherapy|"Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.~Response to the study treatment will be determined according to the criteria proposed in the “Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphomas” by Cheson et al (23)."|At completion of cycle 4, 6, and 8||||Percentage of participants|||Number
1285873|NCT00183963|Secondary|Number of Participants With Changes in Mammographic Density|The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.|6 months after treatment of last patient enrolled|Analysis was not conducted since there was only 1 subject accrued on to each of the treatment arms.||||||
1285874|NCT00183963|Primary|Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment|Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.|6 months after treatment of last patient enrolled|Analysis was not conducted since there was only 1 subject randomized on to each of the treatment arms.||||||
1285875|NCT00183872|Secondary|Progression Free Survival|Progression free survival is measured from the start of treatment until the time the participant is first recorded as having disease progression, or death due to any cause. If a participant has not progressed or died, progression free survival is censored at the time of the last follow up.|every 2 cycles|Population analyzed included all participants who received at least 6 weeks of treatment (or who were discontinued due to progressive disease or for reason of toxicity within the first 6 weeks of study). Two subjects had no tumor evaluation and follow up data available. Analysis was per protocol.|||Months||95% Confidence Interval|Median
1285876|NCT00183872|Primary|Objective Response (Complete, Partial, Stable and Progression)|Objective response was defined using standard RECIST criteria. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.|every 2 cycles|Population analyzed included all participants who received at least 6 weeks of treatment (or who were discontinued due to progressive disease or for reason of toxicity within the first 6 weeks of study). Two subjects had no tumor evaluation and follow up data available. Analysis was per protocol.|||participants|||Number
1286238|NCT00176644|Secondary|To Measure Quality of Life of Patients Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).||||||
1285877|NCT00183794|Secondary|Median Time to Progression (Months)|Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996)|6 months after enrollment of last patient|All participants who receive the first course of treatment are included in the summary of PFS.|||Months||Full Range|Median
1285878|NCT00183794|Primary|Tumor Response Type: CR, PR, SD or PD|Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.|6 months after enrollment of last participant|Participants with evaluable or measurable tumor, who complete 2 courses of treatment will be included in analysis of tumor response.|||Participants|||Number
1285879|NCT00183729|Secondary|Functional Recovery|Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)|week 0, week 12|intent to treat analysis; data presented are the week 12 data from the mixed effect model|||units on a scale||Standard Error|Least Squares Mean
1285880|NCT00183729|Secondary|Incidence of Major Depressive Disorder|cumulative incidence over 12 weeks of follow-up|week 12||||Participants|||Count of Participants
1285881|NCT00183729|Primary|Depressive Symptoms|Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)|week 0, week 12||||units on a scale||Standard Deviation|Mean
1285882|NCT00183677|Primary|Responder and Remission Status (%), Based on the Depression Rating Scale Score|The Hamilton Depression Rating Scale, 17 items (HAMD-17, range 0-52) was used to measure changes in depression severity from baseline to endpoint. Clinical Responder status was defined as > 50% improvement (i.e., reduction) in HAMD-17 score from baseline to endpoint. Clinical Remission status was defined as HAMD-17 score < 8 at endpoint (week 12 visit).|Measured at Week 12|97 patients with MDD (42 Female) enrolled in the 12 week study, 53 patients (27 Female) completed. Only completers were included in the primary outcome measure.|||participants|||Number
1285883|NCT00183625|Secondary|Body Mass Index|Intent was to compare medication and not work group conditions. This was initially assessed at baseline and includes total time on either risperidone or olanzapine up to 18 months.|First 18 months of study||||kg/m^2||Standard Error|Least Squares Mean
1285884|NCT00183625|Primary|Total Weeks Worked||24 months|Data were analyzed for work condition (IPS with or without WIPS) and not for medication (risperidone or olanzapine)|||Weeks||Standard Deviation|Mean
1285885|NCT00183469|Primary|Mania Rating Scale|Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.|up to 8 months|all randomized subjects|||units on a scale||Standard Error|Mean
1285886|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||18 months||||participants|||Number
1285887|NCT00183456|Primary|Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)||18 months||||participants|||Number
1285888|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)||18 months||||participants|||Number
1285889|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)||18 months||||participants|||Number
1285890|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)||18 months||||participants|||Number
1285891|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)||18 month||||participants|||Number
1285892|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||12 months||||participants|||Number
1285893|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)||12 months||||participants|||Number
1285894|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||6 months||||participants|||Number
1285895|NCT00183456|Primary|Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)|Number of participants that had 2 or more sex partners in the past 90 days.|6 months||||participants|||Number
1285896|NCT00183443|Secondary|Social and Occupational Functioning Assessment Scale (SOFAS)|The Social and Occupational Functioning Assessment Scale (SOFAS) provides a rating of global social and occupational function independent of clinical symptoms. SOFAS is provided in the Diagnostic and Statistical Manual (DSM-IV) as an Axis V measure. The SOFAS is a global rating of current functioning, which is scored positively on a scale from 0 to 100. Higher scores represent higher levels of functioning. This instrument is a one-item rating of consumer functioning.|Week 12||||units on a scale||Standard Deviation|Mean
1285897|NCT00183443|Secondary|Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).|Week 12||||units on a scale||Standard Deviation|Mean
1285898|NCT00183443|Secondary|Clinical Global Impression Scale for Bipolar Disorder (CGI-BD)|The Clinical Global Impression (CGI) rating scale was modified by Spearing and colleagues (1997) for use in bipolar disorder. CGI scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. The revised CGI-Bipolar Version (CGI-BP) is effective in rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness. The CGI-BP is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal, not ill) to 7 (very severely ill). Each component of the CGI is rated separately; the instrument does not yield a global score. Only severity of illness scores are reported. Increased scores represent increased illness severity|Week 12||||units on a scale||Standard Deviation|Mean
1285899|NCT00183443|Secondary|Hamilton Rating Scale for Depression (HAM-D,17)|The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The 17-item Likert-type scale (range 0-50) includes eight questions with a 5-point scale (ranging from 0=not present to 4=severe) and nine items scored from 0 to 2. Higher scores indicate increased depression severity. The total sum of these 17 answers is used to arrive at the final score: normal (0-7), mild (8-13), moderate (14-18), severe (19-22), or very severe (>=23).|Week 12||||units on a scale||Standard Deviation|Mean
1285900|NCT00183443|Primary|Symptoms of Mania, as Measured by Young Mania Rating Scale|Symptoms of mania, as measured by Young Mania Rating Scale. The scale is eleven-item multiple choice diagnostic questionnaire (range 0-60), which psychiatrists use to measure the severity of manic episodes in children and young adults. Typically, 20 is the minimum score required for mania. Higher scores represent increased severity of mania symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
1285901|NCT00183430|Primary|Change in Sleep Assessed by the Pittsburgh Sleep Quality Index|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 8.|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.|||Units on a Scale||Standard Deviation|Mean
1285902|NCT00183430|Primary|Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS|"Item B-2 recurrent distressing dreams of the event is a single item from teh Clinician Administered PTSD Scale (CAPS). The rating consists of two parts: Frequency plus Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. The total minimum score = zero. The total maximum score = 8. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 8."|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 4.|||Units on a Scale||Standard Deviation|Mean
1285903|NCT00183430|Primary|Clinical Global Impression of Change|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The Clinical Global Impression of Change is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from Baseline to Week 8.|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.|||Units on a Scale||Standard Deviation|Mean
1285904|NCT00183391|Secondary|HALP Rebound Effects Questionnaire|Questionnaire, qualitative assesses symptoms of rebound (moodiness, irritability, aggression, and ADHD symptoms) when the medication wears off at night.|up to 14 weeks|data not collected||||||
1285905|NCT00183391|Secondary|Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire|Questionnaire, qualitative designed to collect family history, prenatal environmental influences, and developmental history.|Measured at screening|data not collected||||||
1285906|NCT00183391|Secondary|Sleep Logs|Questionnaire, qualitative|Measured daily throughout the study|data not collected||||||
1285907|NCT00183391|Secondary|Actigraphy|Measure of physical activity|Measured daily throughout the study|data not collected||||||
1285908|NCT00183391|Secondary|Permanent Mathematics Product Test (PERMP)|Measure of fluency in performance of simple mathematics, sum, lower = worse|up to 14 weeks|data not collected||||||
1285909|NCT00183391|Secondary|Social Skills Rating Scale (SSRS)- Teacher Version|Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.|up to 14 weeks|data not collected||||||
1285910|NCT00183391|Secondary|Child Behavior Checklist (CBCL)|CBCL Total Score, measure of psychosocial problems, higher is worse.|Measured at screening|data not collected||||||
1285911|NCT00183391|Secondary|Conners Teacher Rating Scale- Short|Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse|up to 14 weeks|data not collected||||||
1285912|NCT00183391|Secondary|Conners-Wells Adolescent Self Report|Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse|up to 14 weeks|data not collected||||||
1285913|NCT00183391|Secondary|SES (Hollingshead)|Measure of socioeconomic status, score calculated from averaging likert responses, lower = worse|up to 14 weeks|data not collected||||||
1285914|NCT00183391|Secondary|Vital Signs - Pulse|Heartbeats per minute. Range varies from 50-205 depending on age and level of activity.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||beats per minute||Standard Deviation|Mean
1285915|NCT00183391|Secondary|Vital Signs - Diastolic Blood Pressure|Diastole blood pressure - blood pressure when the heart muscle is between beats. normal range varies by age, sex, height and weight and can range from 34mm Hg to 90mmHg|up to 14 weeks|see participant flow section for participants that did not complete blocks|||mm HG||Standard Deviation|Mean
1285916|NCT00183391|Secondary|Vital Signs - Systolic Blood Pressure|Systolic blood pressure - the amount of pressure in arteries during contraction of the heart muscle Normal range varies by age, sex, height and weight and can range from 80mm Hg to 130mmHg|up to 14 weeks|see participant flow section for participants that did not complete blocks|||mm HG||Standard Deviation|Mean
1285917|NCT00183391|Secondary|Tics: Total Impairment|Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285918|NCT00183391|Secondary|Tics: Total Phonic|Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285919|NCT00183391|Secondary|Tics: Total Motor|Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285920|NCT00183391|Secondary|Assessment of Affective Range (AAR)|Affective problems. This scale consists of 8 items, scored 0-3, with 0 representing no problems and 3 representing extreme problems. This analysis presents sum of scores, higher is worse. Full range from 0 to 24. This score does not have psychometrics available.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285921|NCT00183391|Secondary|Children's Sleep Questionnaire|Children's Sleep Problems Severity, sum of scores, higher is worse.The scale assessed contains 16 items, each scored 0 to 3, with 0 representing no problems and 3 representing daily problems. total range from 0 to 48. This score does not have psychometrics available.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285922|NCT00183391|Secondary|Continuous Performance Test (CPT)|CPT Commissions, impulsive responses, higher score is worse. This scale is based on t-scores and does not have psychometrics available.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||T-scores||Standard Deviation|Mean
1285923|NCT00183391|Secondary|Child Conflict Index (CCI)|Measure of conflict within the home over the past 24 hours. The CCI is a validated measure of family conflicts in the home and is completed by parents. It consists of 42 items (for boys) or 36 items (for girls) reflecting attention-seeking and conflictual behavior, as well as negativity and withdrawal. Items are scored as yes (1 point) or no (0 points). Mean score between 0 and 1 reported, with higher score indicating greater conflict.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285924|NCT00183391|Secondary|Social Skills Rating Scale (SSRS)- Parent Version|Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||t-score||Standard Deviation|Mean
1285925|NCT00183391|Secondary|Clinical Global Impressions (CGI)- Severity|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285926|NCT00183391|Secondary|ADHD-RS Inattention|Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0–27. Higher score indicates higher probability of diagnosis.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285927|NCT00183391|Secondary|ADHD - H/I|Attention deficit/hyperactivity disorder - hyperactivity/impulsivity (ADHD- H/I). Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0–27. Higher score indicates higher probability of diagnosis.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285928|NCT00183391|Secondary|Treatment Preference Survey||Measured at ends of treatments one and two||||percentage of participants|||Number
1285929|NCT00183391|Primary|ADHD-RS Total Score|ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0–54. Higher score indicates higher probability of diagnosis.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
1285930|NCT00183339|Secondary|Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)|The Aberrant Behavior Checklist (ABC) is a caregiver completed rating scale that assesses problem behaviors frequently seen in individuals with developmental disabilities. There are a total of 58 items on 5 subscales that are rated from 0 - not at all a problem to 3 - problem is severe in degree. The ABC-I consists of 15 items that reflect mood swings, self-injury and aggression. The subscale score is the sum of the score on each of the 15 items. The minimum score on the ABC-I is 0 and the maximum score is 45. Higher scores reflect more severe behavioral problems. A score > or = to 18 is generally considered clinically significant.|12 months||||units on a scale||Standard Deviation|Mean
1285931|NCT00183339|Secondary|Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire|This is a caregiver completed measure that assesses the extent to which the caregiver feels care of the participant influences the caregiver's and other family members' emotional states and/or activities. There are a total of 22 items rated from 1 - not at all to 5 - very much (with one item reverse scored). Total score is the sum of all the items (with one item reverse scored). There are three subscales objective strain -12 items, internalized subjective strain 6 items, externalized subjective 4 items. The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.|12 months||||units on a scale||Standard Deviation|Mean
1285933|NCT00183339|Primary|Rate of Recruitment|In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment* 2sites ) /[ # participants randomized ] and compared it to the typical # of months required to recruit an older child with ASD for a double-blind 12 week placebo controlled medication study, which is typically about 1.2 months at each of the sites involved in the study.|19 months||||months/participant at 1 site|||Number
1285934|NCT00183274|Secondary|Clinical Global Impressions, Severity of Illness|"The CGI provides an overall clinician-determined summary measure that takes into account a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.~The CGI is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~Results of the Placebo After Placebo group in Phase 3 were not entered due to sample size limitations."|Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse)|The primary efficacy analytic method was time to relapse analyses estimated using a discrete time Cox proportional hazards model.Chisquare analyses were used to contrast relapse or responder rates. In the case of small cell sizes, Fisher exact test replaced chisquare analysis.|||Severity Score||Standard Deviation|Mean
1285935|NCT00183274|Primary|Hamilton Rating Scale for Anxiety|"Hamilton Rating Scale for Anxiety - The assessment of anxiety states by rating~Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe."|Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse)|The primary efficacy analytic method was time-to-relapse analyses estimated using a discrete-time Cox proportional hazards model.|||HAM-A Rating Score||Standard Deviation|Mean
1285936|NCT00183248|Secondary|Number of Graft-versus-host Disease (GVHD) Events|A disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. Also called graft-versus-host disease.|Three years post kidney transplant|Intent-to-Treat|||GVHD Events|||Number
1285937|NCT00183248|Secondary|Number of Chronic Allograft Nephropathies|"Number of chronic allograft nephropathies[1,2,3] at 3 years post kidney transplant.~Chronic allograft nephropathy is defined as renal biopsies with Banff 97 Grade I or greater[2] with higher numeric scores indicating more severe nephropathy~The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification[3]~Reference: Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Three years post kidney transplant|Participants who experienced nephropathies|||Nephropathy Events|||Number
1285938|NCT00183248|Secondary|Number of Kidney Biopsy-proven Acute Rejection|"Biopsy-proven acute renal (kidney) rejection[1,2].~Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]~Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Three years post kidney transplant|Participants who experienced an acute rejection|||Rejection Events|||Number
1285939|NCT00183248|Secondary|Graft Survival at Three Years Post-Transplant|"Number of participants that did not experience kidney graft failure[1] at three years post-transplant~[1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation."|Three years post kidney transplant|Intent-to-Treat|||participants|||Number
1285940|NCT00183248|Secondary|Participant Survival at Three Years Post Kidney Transplant||Three years post kidney transplant|Intent-to-Treat|||participants|||Number
1285941|NCT00183248|Primary|Overall Kidney Graft Survival at One Year Post-Transplant|"Number of participants that did not experience kidney graft failure[1] at one year post-transplant~[1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation."|One year post kidney transplant|Intent-to-treat|||participants|||Number
1285942|NCT00183248|Primary|Overall Participant Survival at One Year Post Kidney Transplant||One year post kidney transplant|Intent-to-Treat|||participants|||Number
1285943|NCT00183196|Primary|Time to Relapse to Drinking|Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.|16 weeks|Subjects who entered the analysis were all people with any drinking data post randomization. There was 2 people in naltrexone plus gabapentin, 1 person in naltrexone alone and 1 person in placebo group that had no post-randomization drinking data and were therefore not included in the intent to treat analysis presented.|||days||Standard Error|Mean
1285944|NCT00183092|Secondary|Change in Semantic Verbal Fluency (Naming Animals)|Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (naming animals) is semantic. Higher scores indicate better cognition.|Baseline, 2 months|Subjects still alive and able to tolerate cognitive testing at month 2 visit.|||number of words generated||Full Range|Mean
1285945|NCT00183092|Secondary|"Change in Phonemic Fluency (Words Beginning With Letter D)"|"Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (words beginning with letter D) is phonemic. Higher scores indicate better cognition."|Baseline, 2 months|Subject still alive and able to tolerate cognitive testing at month 2 visit|||number of words generated||Full Range|Mean
1286009|NCT00180687|Secondary|Number of Vomiting / Nausea Episodes|Nausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.|24 hours||||Number of vomitting / Nausea episodes||Full Range|Mean
1285946|NCT00183092|Secondary|ADAS-Cog Change After 2 Months Among Survivors|ADAS-cog measures cognitive performance by combining ratings of 11 components (word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering instruction, spoken language, word finding, comprehension) representing six areas of cognition: memory; language; orientation to time, place and person; construction of simple designs and planning; and performing simple behaviors in pursuit of a basic, predefined goal. Seven components are scored as the ‘number incorrect’. For example, in the commands component, the number of five commands performed incorrectly (range: 0-5). Four components are scored from 0 (no limitations) to 5 (max limitations) as the examiner's perception of remembering instructions, spoken language ability, word finding and comprehension. Component scores are summed into a total ADAS-cog score ranging from 0-75, with low scores indicating better cognitive performance.|Baseline, 2 months|Subjects still alive and able to tolerate cognitive testing at Month 2 visit.|||units on a scale||Full Range|Mean
1285947|NCT00183092|Secondary|Change in Rankin Score After 2 Months|"The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead. For subjects unable to return for the 2-month visit, Rankin score was assessed via telephone."|Baseline, 2 months|For subjects still alive at month 2 and assessed at the 2-month visit or via telephone|||units on a scale||Full Range|Mean
1285948|NCT00183092|Secondary|Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months|Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB). The CDR is obtained through semistructured interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The global CDR score is computed via an algorithm. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. A higher value and/or positive change is worse. For subjects unable to return for month-2 visit, CDRS-SB was performed via telephone.|Baseline, 2 months|For subjects still alive at month 2 and assessed at the 2-month visit or via telephone|||units on a scale||Full Range|Mean
1285949|NCT00183092|Secondary|Barthel Score Change After 2 Months|An ordinal scale used to measure performance in activities of daily living. Scores range from 0 (worst, fully dependent) to 100 (best, independent); higher score associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. 10 individual items are scored and summed to derive the overall Barthel index score. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The amount of time and physical assistance required to perform each item are considered in scoring each item. For subjects unable to return for month-2 visit, Barthel Index was performed via telephone.|baseline, 2 months|One surviving subject in the quinacrine arm did not attend the 2-month visit and was lost-to-followup; for a second surviving subject in the quinacrine arm, the Barthel Index was inadvertently not performed at the 2-month visit.|||units on a scale||Full Range|Mean
1285950|NCT00183092|Secondary|Change in Mini–Mental State Examination (MMSE) After 2 Months|The mini–mental state examination (MMSE) is a brief 30-point questionnaire that is used to screen for cognitive impairment. In about 10 minutes it samples functions including arithmetic, memory and orientation. A score greater than or equal to 25 points (out of 30) indicates a normal cognition. Lower scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment. Low to very low scores correlate closely with the presence of dementia, although other mental disorders can also lead to abnormal findings on MMSE testing.|Baseline to Month-2|Subjects still alive, who attended the month-2 visit and were willing and able to tolerate cognitive testing. 1 subject in each arm did attend the 2-month visit but did not cooperate fully with the MMSE, which was therefore not scored.|||units on a scale||Full Range|Mean
1285951|NCT00183092|Primary|Primary Survival|Participants alive after 2 months on study treatment|Randomization to Month-2||||participants|||Number
1285952|NCT00182793|Primary|5-Year Overall Survival Rate|Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up|From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment.|Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.|||percentage of participants||95% Confidence Interval|Median
1285953|NCT00182793|Primary|5-Year Relapse-free Survival Rate|Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically.|From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment|Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.|||percentage of participants||95% Confidence Interval|Median
1285954|NCT00182767|Primary|Maximum Tolerated Dose|The phase I component of the study included 30 patients with breast and ovarian cancer. A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported. Please see (Chuang et al., 2010) for additional details|Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD).|The phase I component of the study included 30 patients with breast and ovarian cancer.|||mg/m2|||Number
1285955|NCT00182767|Secondary|Progression-free Survival|We will summarize progression-free survival by Kaplan-Meier survival analysis.|The time from start of treatment to time of progression or death, assessed up to 2 years||||months||95% Confidence Interval|Median
1285958|NCT00182754|Secondary|Average Quality-of-life|Quality of life will be recorded and analyzed in a descriptive, exploratory fashion. We acknowledge that this study will represent the first to attempt a prospective assessment of quality of life in patients with symptomatic ascites. The underlying hypothesis of this quality of life assessment is that patients who are receiving octreotide will enjoy a better quality of life compared to patients who receive placebo. Quality of life scores from the CLDQ will be summed for all patients on a monthly basis. Again we anticipate high patient drop out rates over time within these two cohorts. With due diligence, we will attempt to ascertain the reason for each patient drop out, and appropriate imputation techniques will be employed for each.Quantified as: 1='All of the time' 2='Most of the time' 3='A good bit of the time' 4='Some of the time' 5='A little bit of the time' 6='Hardly any of the time' 7='None of the time' 0='Missing';|Up to 2 years||||QOL score||Full Range|Median
1285959|NCT00182754|Secondary|Number of Paracenteses|We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.|Up to 2 years||||number of paracenteses per patient||Full Range|Median
1285960|NCT00182754|Primary|Median Time to Paracentesis|Kaplan Meier curves will be constructed for each group; patients lost to follow up will be censored. A log rank test will be used to compare groups. We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.|Up to 2 years||||days||Full Range|Median
1285961|NCT00182728|Secondary|Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT||3 months|No data were collected for this biomarker. Although samples were obtained from patients, they were never processed and analyzed.||||||
1285962|NCT00182728|Secondary|Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT||3 months|No data were collected for this biomarker. Although samples were obtained from patients, they were never processed and analyzed.||||||
1285963|NCT00182728|Secondary|Association of Phosphorylated Epidermal Growth Factor Receptor (EGFR) , Human Epidermal Growth Factor Receptor 2 (HER2), p44/42 Mitogen-activated Protein Kinase (MAPK), and Protein Kinase B (Akt) in Breast Tumors and Normal Tissue Before and After IORT||3 months|No data were collected for any of these biomarkers. Although samples were obtained from patients, they were never processed and analyzed.||||||
1285964|NCT00182728|Primary|Ipsilateral Breast Recurrence|Percentage of participants who experienced a ipsilateral breast event (tumor bed recurrence versus elsewhere in breast).|5 years|"There were 71 patients who received IORT. Of those 71 patients, 18 received further local therapy due to high risk pathology. The results include the 53 patients who received IORT without further local therapy."|||percentage of participants||95% Confidence Interval|Number
1285965|NCT00182728|Primary|Incidence of Grade 3/4 Toxicity|"Skin and subcutaneous toxicity were graded by a radiation oncologist according to the common terminology criteria for adverse events version 3.0. Toxicities directly, probably, or possibly related to the radiation were included. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE) based on this general guideline:~Grade 1 Mild Adverse Event Grade 2 Moderate Adverse Event Grade 3 Severe Adverse Event Grade 4 Life-threatening or disabling Adverse Event Grade 5 Death related to Adverse Event"|3 months||||Participants|||Count of Participants
1285966|NCT00182728|Primary|Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients|"Rates of good/excellent cosmesis was evaluated using the following criteria:~Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.~Good – there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape."|1 year follow up visit|Patients who received IORT alone. 42 patients assessed their cosmetic outcome.|||Participants|||Count of Participants
1285967|NCT00182728|Primary|Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician|"Rates of good/excellent cosmesis was evaluated using the following criteria:~Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.~Good – there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape."|1 year follow up visit|Patients who received intraoperative radiation therapy (IORT) alone. 56 patients were assessed.|||Participants|||Count of Participants
1285968|NCT00182689|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|0 - 2 years||||months||95% Confidence Interval|Median
1285969|NCT00182689|Primary|Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|8 weeks to 2 years|All eligible patients who received treatment were included in this measure.|||percentage of participants||95% Confidence Interval|Number
1285970|NCT00182689|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after completion of every 28-day cycle.|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants with a given type of AE|||Number
1285971|NCT00182637|Secondary|Toxicity||2 years|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.||||||
1285974|NCT00182091|Secondary|Change in Visceral Abdominal Adipose Tissue|Change in visceral abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.|||millimeters squared||Standard Deviation|Mean
1285975|NCT00182091|Secondary|Change in Total Abdominal Adipose Tissue|Change in total abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.|||millimeters squared||Standard Deviation|Mean
1285976|NCT00182091|Secondary|Change in Total Fat Mass|Change in total fat mass in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.|||kilograms||Standard Deviation|Mean
1285977|NCT00182091|Primary|Change in High-sensitivity C-reactive Protein|Change in high-sensitivity C-reactive protein in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.|||mg/liter||Standard Deviation|Mean
1285978|NCT00182078|Primary|Diagnostic Interview for Children and Adolescents (DICA) - Child|The DICA is a semi-structured interview, and was used to measure Post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to children who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.|Baseline to Week 24|Intention to treat (ITT). Analysis was conducted on participants with available data.|||units on a scale||Standard Deviation|Mean
1285979|NCT00182078|Secondary|The Child Depression Inventory (CDI)|The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined.|Baseline to Week 12|Intention to treat (ITT). Analysis was conducted on participants with available data.|||units on a scale||Standard Deviation|Mean
1285980|NCT00182078|Primary|Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent|The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.|Baseline to Week 24|Intention to treat (ITT). Analysis was conducted on participants with available data.|||units on a scale||Standard Deviation|Mean
1285981|NCT00182000|Secondary|Disability Inventory||Post-treatment (week 5)|||||||
1285982|NCT00182000|Secondary|Short-Form Health Survey (SF-36)||Post-treatment (week 5)|||||||
1285983|NCT00182000|Secondary|Obsessional Beliefs Questionnaire (OBQ)||Post-treatment (week 5)|||||||
1285984|NCT00182000|Secondary|Beck Anxiety Inventory (BAI)||Post-treatment (week 5)|||||||
1285985|NCT00182000|Secondary|Beck Depression Inventory (BDI)||Post-treatment (week 5)|||||||
1285986|NCT00182000|Secondary|Clinical Global Impressions Scale (CGI)||Post-treatment (week 5)|||||||
1285987|NCT00182000|Primary|Yale-Brown Obsessive Compulsive Scale (YBOCS)|A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).|Post-treatment (week 5)|Thirty-three participants were enrolled. Four participants decided not to participate in between enrolling and beginning treatment. Six participants withdrew from the study before the mid-treatment evaluation; 1 participant withdrew from the study after the mid-treatment evaluation, and this participant's data was carried forward.|||units on a scale||Standard Deviation|Mean
1285988|NCT00181883|Primary|Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score|The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.|Baseline to 8 weeks||||Units on a scale||Standard Deviation|Mean
1285989|NCT00181844|Primary|Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS)|Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.|baseline to 12 weeks||||Units on a scale||Standard Deviation|Mean
1286010|NCT00180687|Primary|Reduction in Postoperative Pain|Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.|0 hours, 6 hours, 12 hours, 24 hours||||units on a scale||Full Range|Mean
1285990|NCT00181766|Primary|The Adult AISRS|The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.|baseline and 6 Weeks|All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule. Baseline and endpoint AISRS scores were compared used paired t-tests. Statistical significance was determined at alpha level 0.05.|||scores on a scale||Standard Deviation|Mean
1285991|NCT00181766|Primary|ADHD-Clinical Global Impression|The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.|6 Weeks|All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule.|||subjects|||Number
1285992|NCT00181714|Primary|Cigarette Smoking|Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)|24 months|Clinical trial subjects included in this analysis included those adolescents who took at least one dose of OROS MPH following baseline assessment (N=154), with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule of 24 months|||percent|||Number
1285993|NCT00181623|Secondary|Breast Milk Prolactin Levels|Treatment group|28 days||||mcg/L||Standard Error|Mean
1285994|NCT00181623|Primary|Breast Milk Production|Treatment group|28 days|One subject did not qualify after screening.|||mL/day||Standard Error|Mean
1285995|NCT00181610|Secondary|Breast Milk Prolactin Levels||7 days||||mcg/L||Standard Error|Mean
1285996|NCT00181610|Primary|Change in Breast Milk Volume Baseline to 7 Days||7 days||||% change from baseline||Standard Error|Mean
1285997|NCT00181285|Primary|Number of Participants Who Considered the Pneumatic Vest Convenient to Use|The study vest was convenient to use.|After four treatments of 15 minutes each|1 participant in the Sham group and 1 participant in the Active group had missing data for the question regarding the convenience of the pneumatic vest, therefore these participants were not included in the number analyzed for the outcome measure data table below.|||Participants|||Count of Participants
1285998|NCT00181285|Primary|Patient Adherence to High Frequency Chest Wall Oscillation|Patient adherence to therapy after four treatments.|After four treatments of 15 minutes each||||Percent of 60 minutes prescribed||Standard Deviation|Mean
1285999|NCT00181207|Secondary|Quality of Life|The SF-36 is used to measure health related quality of life. It assesses eight health concepts and provides physical and mental health summary scores. The summary scores range from 0 to 100, with 0 representing the worst and 100 the best quality of life.|Change from baseline to 12 weeks||||units on a scale||Inter-Quartile Range|Mean
1286000|NCT00181207|Primary|The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.|count of exacerbations per group per 12 weeks. An exacerbation was defined based on three major symptoms: increasing dyspnea, increasing sputum purulence and increasing sputum volume. Exacerbations were counted if there were at least 2 of these 3 symptoms.|12 weeks||||exacerbations per 12 weeks||Inter-Quartile Range|Mean
1286001|NCT00181168|Secondary|Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity||21 Days|||||||
1286002|NCT00181168|Primary|PET-CT Fusion Scanning Sensitivity|PET/CT was performed before (basal PET) and 24–48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET.|21 Days||||percentage of participants||95% Confidence Interval|Number
1286003|NCT00181155|Secondary|Cardiac PCr/ATP Post Intravenous Infusion|The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.|acute (within 15 minutes of single infusion)|Data were analyzed for all participants who completed the MRS per protocol.|||ratio||Standard Deviation|Mean
1286004|NCT00181155|Primary|Myocardial CK Flux Post Intravenous Allopurinol Infusion.|The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.|acute (within 15 minutes of single infusion)|Data were analyzed for all participants who completed the MRS per protocol.|||umol/g/sec||Standard Deviation|Mean
1286005|NCT00181155|Secondary|Cardiac PCr/ATP Pre Intravenous Infusion|The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.|Onset of image acquisition.|Data were analyzed for all participants who completed the MRS per protocol.|||ratio||Standard Deviation|Mean
1286006|NCT00181155|Primary|Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion|Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion|Onset of imaging acquisition.|Data were analyzed for all participants who completed the MRS per protocol.|||umol/g/sec||Standard Deviation|Mean
1286007|NCT00180687|Secondary|Postoperative Morphine Use|The reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events|24 Hoiurs||||mg||Full Range|Mean
1286008|NCT00180687|Secondary|Hours Needed for Safe Mobilization|Drowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.|24 Hours||||Hours needed for safe mobilization||Full Range|Mean
1286058|NCT00180323|Primary|Aortic Velocity Time Integral (VTI)|Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).|At implant (baseline), 3 months and 6 months Follow-up||||cm||Standard Deviation|Mean
1286011|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286012|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286013|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286014|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286015|NCT00180479|Secondary|In-segment % Diameter Stenosis (% DS)|Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 – in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percent of in-segment diameter stenosis||Standard Deviation|Mean
1286016|NCT00180479|Secondary|In-stent % Diameter Stenosis (% DS)|In-stent: Within the margins of the stent, the value calculated as 100 * (1 – in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percent diameter stenosis||Standard Deviation|Mean
1286017|NCT00180479|Secondary|% Volume Obstruction (% VO)|Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percent of volume obstruction||Standard Deviation|Mean
1286018|NCT00180479|Secondary|In-stent Late Loss|In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||millimeters||Standard Deviation|Mean
1286019|NCT00180479|Secondary|Distal Late Loss|Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||millimeters||Standard Deviation|Mean
1286020|NCT00180479|Secondary|Proximal Late Loss|Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||millimeters||Standard Deviation|Mean
1286021|NCT00180479|Secondary|Acute Success: Clinical Procedure|Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.|In-hospital||||percentage of participants|||Number
1286022|NCT00180479|Secondary|Acute Success: Clinical Device|Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.|In-hospital||||percentage of participants|||Number
1286059|NCT00180271|Secondary|Recurrent Heart Failure Events|"The MADIT-CRT secondary outcome evaluated the effects of CRT-D, relative to ICD, on the recurrence of heart failure events over the full study period An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:~administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician’s office, etc.), or~administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay."|Time of event, DSMB review||||Participants|||Count of Participants
1286023|NCT00180479|Secondary|Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection|"Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition.~Persisting dissection @ follow-up, present post-procedure."|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percentage of participants|||Number
1286024|NCT00180479|Secondary|In-segment % Angiographic Binary Restenosis (% ABR) Rate|Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percentage of participants|||Number
1286025|NCT00180479|Secondary|In-stent % Angiographic Binary Restenosis (% ABR) Rate|Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percentage of participants|||Number
1286026|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286027|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286028|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event(MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286029|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286030|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286031|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286032|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286033|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|4 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286034|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|3 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286035|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286036|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286037|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286038|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286039|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286040|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286041|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286042|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286043|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|1 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286044|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286045|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286046|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286047|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286048|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286049|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|2 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286050|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286051|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286052|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
1286053|NCT00180479|Secondary|Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|270 days|All patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1286054|NCT00180479|Primary|Primary Endpoint: In-segment Late Loss (LL)|In-segment minimal lumen diameter (MLD) post-procedure minus (–) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.|240 days|Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.|||millimeters||Standard Deviation|Mean
1286055|NCT00180323|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up|implant (baseline), 3 Months, 6 Months||||% of cardiac volume||Standard Deviation|Mean
1286056|NCT00180323|Secondary|6 Minute Walk Test|6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.|implant (baseline), 3 months and 6 months Follow-up||||meter||Standard Error|Mean
1286057|NCT00180323|Primary|Optimal AV-Delay (AVD)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.|Implant (baseline), 3 months and 6 months Follow-up||||ms||Standard Deviation|Mean
1286060|NCT00180271|Primary|Mortality From Any Cause or First Heart Failure (HF) Event|"MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:~administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician’s office, etc.), or~administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay."|Outcome measured at average follow-up duration of 2.4 years.|"Analysis was performed on an intention-to-treat basis and counted the time to first event. The category Patients with Death at Any Time, includes deaths that occurred after the first heart failure event."|||Participants|||Number
1286061|NCT00179959|Primary|Change in Eczema Area and Severity Index (EASI)Scores According to Location|The proportion of affected body surface area (BSA) was estimated from 4 designated body regions(head/neck, upper limbs, trunk, and lower limbs),and the Physician’s Assessment of Individual Signs was determined for each region by grading signs of AD on a 4-point scale. Both the proportion of affected BSA and the Physician’s Assessment of Individual Signs score were used to calculate the EASI score,a validated composite score that ranges from 0 (clear) to 72 (very severe).|Baseline and 3 months|Analysis was per protocol.|||Change in EASI Score||Standard Deviation|Mean
1286062|NCT00179673|Secondary|Number of Participants With Adverse Events (AEs)|"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.~The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:~Grade 1 = Mild~Grade 2 = Moderate~Grade 3 = Severe~Grade 4 = Life threatening~Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months.|Safety Population, which includes all participants who received at least one dose of study drug.|||participants|||Number
1286063|NCT00179673|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment.|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent to treat population|||months||95% Confidence Interval|Median
1286064|NCT00179673|Secondary|The Duration of Response|The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Includes participants with a response to treatment|||months||95% Confidence Interval|Median
1286065|NCT00179673|Secondary|Percentage of Participants With Tumor Control|"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).~PD was defined as~≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.~Appearance of any new lesion during or at the end of therapy."|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders|||percentage of participants||95% Confidence Interval|Number
1286066|NCT00179673|Primary|Percentage of Participants With Response|"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)~Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).~PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD."|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
1286075|NCT00179621|Secondary|Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period|"Counts of study participants who had adverse events (AEs) during the double-blind period by MedDRA System Organ Class (SOC) and preferred term. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|up to week 52|Safety population.|||participants|||Number
1286067|NCT00179660|Secondary|Number of Participants With Adverse Events (AEs)|"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.~The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:~Grade 1 = Mild~Grade 2 = Moderate~Grade 3 = Severe~Grade 4 = Life threatening~Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 15.2 months.|Safety Population, which includes all participants who received at least one dose of study drug.|||participants|||Number
1286068|NCT00179660|Secondary|Progression-free Survival|"Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.~Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population|||months||95% Confidence Interval|Median
1286069|NCT00179660|Secondary|Duration of Tumor Control|The duration of tumor control was calculated as the time from the first response assessment demonstrating at least stable disease to the first documentation of progressive disease or death due to NHL. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population with tumor control (CR, CRu, PR or SD).|||months||95% Confidence Interval|Median
1286070|NCT00179660|Secondary|Duration of Response|The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population with a response = CR, CRu or PR.|||months||95% Confidence Interval|Median
1286071|NCT00179660|Secondary|Percentage of Participants With Tumor Control|"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).~PD was defined as~≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.~Appearance of any new lesion during or at the end of therapy."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
1286072|NCT00179660|Primary|Percentage of Participants With Response|"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)~Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).~PR: 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
1286073|NCT00179647|Primary|Overall Incidence of Adverse Events|Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.|Median time-on-study=18.3 weeks|Subjects who received study drug|||Participants|||Number
1286074|NCT00179647|Primary|Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.|Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.|Median time-on-study=18.3 weeks|||||||
1286239|NCT00176644|Primary|To Evaluate the Antitumor Activity, as Measured by PSA Response Rate in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.||4 years||||Response rate (percentage)|||Number
1286076|NCT00179621|Secondary|Change From Baseline in the Trial Outcome Index-Fatigue (TOI-F) Endpoints at Week 12|The Trial Outcome Index-Fatigue(TOI-F) composed of the physical and functional subscales of the FACT-G along with the fatigue items from the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-F is 0-108. Higher scores indicate better HRQoL.|Baseline, Week 12|Participants who had both Baseline and Week 12 TOI-F data.|||units on a scale||Standard Deviation|Mean
1286077|NCT00179621|Secondary|Change From Baseline in the Trial Outcome Index-Anemia (TOI-An) Endpoints at Week 12|The Trial Outcome Index-Anemia (TOI-An) composed of the physical and functional subscales of the FACT-G along with the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-An is 0-136. Higher scores indicate better HRQoL.|Baseline, Week 12|Participants who had both Baseline and Week 12 TOI-An data.|||units on a scale||Standard Deviation|Mean
1286078|NCT00179621|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Week 12|"The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire (Yellen, 1997) was used to assess health-related quality of life (HRQoL).~In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning. The overall score range for the FACT-An is 0-188. Higher scores indicate better HRQoL."|Baseline, Week 12|Participants who had both Baseline and Week 12 FACT-An data.|||units on a scale||Standard Deviation|Mean
1286079|NCT00179621|Secondary|Participant Count of Deaths During Double-blind and Open-label by Randomized Group|Count of participant deaths throughout the entire study and reported by the original treatment assignment.|up to 3 years|Safety Population|||Participants|||Number
1286080|NCT00179621|Secondary|Kaplan Meier Estimates of Overall Survival by Randomized Group|Kaplan Meier estimate for median length of survival for study participants as they were randomized at the start of the study.|up to 3 years|Safety population: All randomized participants who received any Lenalidomide or placebo.|||Months||95% Confidence Interval|Median
1286081|NCT00179621|Secondary|Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study|Number of participants who progressed to acute myeloid leukemia during the study, summarized at three different timepoints: first 16 weeks of the double-blind study, week 52 of the double-blind study, and up to 36 months which includes the double-blind and open-label periods of the study. The counts are cumulative by timeframe.|up to 3 years|Intent to treat population. Participants represented in the treatment groups to which they were randomized.|||Participants|||Number
1286082|NCT00179621|Secondary|Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review|The IWG criteria for evaluating cytogenetic response require a minimum of 20 baseline and post-baseline analyzable metaphases using conventional cytogenetic techniques. A major cytogenetic response is defined as no detectable cytogenetic abnormality if preexisting abnormality was present whereas a minor response requires ≥50% reduction in abnormal metaphases. Progression could be concluded based on as few as 3 metaphases if there were additional abnormalities. The best response is represented.|up to 52 weeks|Modified intent to treat population, which is defined as participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Participants had to have had more than 1 post-baseline assessment in order to be evaluable for cytogenetic response.|||Participants|||Number
1286083|NCT00179621|Secondary|Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period|The IWG criteria for bone marrow improvement: a complete remission is bone marrow sampling showing less than 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. A partial remission is ≥ 50% decrease in blasts over pre-treatment. Bone marrow progression is a ≥ 50% increase in blasts that exceed the top range of the pretreatment percentile range: a) <5% blasts b) 5-10% blasts c) 10-20% blasts d) 20-30% blasts. For example, a participant with <5% blasts pretreatment with an on study blast increase of 50% which is now >5% showed bone marrow progression.|up to 52 weeks|Intent to treat population. Participants represented in the treatment groups to which they were randomized. Placebo response is limited to the double-blind phase. There were 10 responders in the placebo group who achieved their response under lenalidomide treatment after crossover to open-label.|||Participants|||Number
1286084|NCT00179621|Secondary|Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period|A major neutrophil response is defined by the International MDS Working Group (IWG) criteria as at least a 100% increase, or an absolute increase of ≥500/mm^3 for participants with absolute neutrophil counts (ANC) of less than 1,500/mm^3 before therapy, whichever is greater. A minor response for such participants is defined as an ANC increase of at least 100%, but absolute increase <500/mm^3.|up to week 52|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline absolute neutrophil counts (ANC) < 1,000/mm^3.|||Participants|||Number
1286085|NCT00179621|Secondary|Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period|The International MDS Working Group (IWG) defines a major platelet response for participants with a pre-treatment platelet count of <100,000/mm^3 as an absolute increase of ≥30,000/mm^3 whereas a minor response is defined as a ≥50% increase in platelet count with a net increase greater than 10,000/mm^3 but less than 30,000/mm^3.|up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline platelet count of <100,000/mm^3 to be included in the analysis.|||Participants|||Number
1286086|NCT00179621|Secondary|Maximum Change From Baseline in Hemoglobin During the Double-blind Period for Participants Who Became Red Blood Cell (RBC) Transfusion Independent for at Least 182 Days|For participants who became RBC transfusion independent for at least 182 days during the double-blind study period, the mean maximum change from baseline in hemoglobin is summarized.|Baseline, up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. MITT participants who were transfusion independent for >= 182 study days are included.|||g/dL||Standard Deviation|Mean
1286087|NCT00179621|Secondary|Duration of Red Blood Cell (RBC) Transfusion Independence for Participants Who Became RBC Transfusion Independent for at Least 182 Days|Mean number of weeks that participants who achieved RBC transfusion independence for at least 182 days were able to maintain RBC transfusion independence. Both double-blind and open-label periods are included.|up to 3 years|The modified intent-to-treat (mITT) population included all participants who achieved RBC transfusion independence for at least 182 days.|||Weeks||Standard Deviation|Mean
1286088|NCT00179621|Secondary|Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for 56 Days|Count of study participants who had no RBC transfusions during any 56 or more consecutive study days during the double-blind period.|Up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.|||Participants|||Number
1286089|NCT00179621|Primary|Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for >= 26 Weeks (182 Days)|The count of study participants who had no RBC transfusions for 26 consecutive weeks or more during the double-blind period.|Up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.|||Participants|||Number
1286090|NCT00179517|Secondary|Changes in Energy, Mood and Anxiety Scores Will be More Favorable With Anastrozole Than With Placebo.|Changes in energy, mood and anxiety scores were measured using The Beck Depression Inventory II and the POMS questionnaire. The Beck Depression Inventory II questionnaire consisted of 21 questions, each with answers ranging from 0-3. The answers for each question were summed. The scale ranged from 0-63 with higher scores meaning a higher depression score (worse score). The POMS questionnaire had a total of 65 questions that measured tension, depression, anger, vigor, fatigue and confusion. The total POMS score ranged from 0-200, with lower scores being better. The POMS tension score ranged from 0-36 with lower scores being better. The POMS depression score ranged from 0-60 with lower scores being better. The POMS anger score ranged from 0-48, lower scores being better. The POMS vigor score ranged from 0-32, lower scores being better. The POMS fatigue score ranged from 0-28, lower scores being better. The POMS confusion score ranged from 0-28 with lower scores being better.|3 month average||||Scores on a scale||Standard Deviation|Mean
1286091|NCT00179517|Secondary|Changes in Seizure Frequency Will be More Favorable With Anastrozole Than With Placebo.|The average change in number of seizures over the 3 month study for the depotestosterone plus anastrozole (T–A) and depotestosterone plus placebo (T–P) were reported.|3 month average||||number of seizures||Standard Deviation|Mean
1286092|NCT00179517|Secondary|Estradiol and Luteinizing Hormone Ratios Will be Lower With Anastrozole Than Placebo.|Estradiol and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The estradiol and luteinizing hormone levels were averaged. The ratio between the average estradiol levels and average luteinizing hormone levels were reported.|3 month average||||Ratio||Standard Deviation|Mean
1286093|NCT00179517|Secondary|Bioactive Testosterone and Luteinizing Hormone Ratios Will be Higher With Anastrozole Than Placebo.|Bioactive Testosterone and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The bioactive testosterone and luteinizing hormone levels were averaged. The ratio between the average bioactive testosterone level and average luteinizing hormone levels were reported.|3 month average||||Ratio||Standard Deviation|Mean
1286094|NCT00179517|Secondary|The Bioactive Testosterone and Estradiol Ratio Will be Higher With Anastrozole Than With Placebo.|Bioactive Testosterone and estradiol levels were measured once a month over the three month study in the treatment and placebo group. The bioactive Testosterone and estradiol levels were averaged The ratio between the average bioactive testosterone level and average estradiol levels were reported.|3 month average||||Ratio||Standard Deviation|Mean
1286095|NCT00179517|Secondary|Estradiol Levels Will Decrease More With Anastrozole Than With Placebo.|Estradiol levels were measured once a month over the three month study in the treatment and placebo group. The average change in estradiol levels was reported.|3 month average||||pg/mL||Standard Deviation|Mean
1286096|NCT00179517|Secondary|Bioactive Testosterone Levels Will Increase More With Anastrozole Than With Placebo.|Bioactive testosterone levels were measured at baseline and once a month over the three month study. The average change in bioactive testosterone levels from baseline to the end of the three month study was reported.|3 month average||||ng/dl||Standard Deviation|Mean
1286097|NCT00179517|Secondary|A Greater Proportion of Men Will Achieve Normalization of Sexual Scores (Sexual Interest Function) Using Anastrozole Than Placebo.|A greater proportion of men will achieve normalization of S-Scores (scores greater than or equal to 16/20) on anastrozole (T-A) than with placebo (T-P). Both Men who achieve normalization of sexual scores and those who did not achieve normalization of sexual scores were reported for anastrozole (T-A) treatment group and the placebo treatment group.|3 month average||||Participants|||Count of Participants
1286098|NCT00179517|Primary|Sexual Function Scores, Calculated Using S-Score and Reynolds’ Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.|S-Scores and Reynolds Questionnaire scores were assessed at baseline and once a month over three months. The average change in score for each questionnaire over the 3 month study was reported. The S-Scores questionnaire measured sexual function and consisted of four questions with five possible answers. The total scale range was 0-20, with higher scores were considered better. S-Scores that were greater than or equal to 16/20 were considered normalized S-Scores. Reynolds Questionnaire is a 21 item survey that monitors sexual interest, activity, satisfaction, and function. The scale for the Reynolds questionnaire for sexual interest was from 0-12, with higher scores being better. The scale for sexual activity was 0-41 with higher scores being better. The sexual satisfaction scale was from 0-21 with higher scores being better. The scale for sexual function was from 0 to -12 with lower scores being better.|3 month average||||Scores on a Scale||Standard Deviation|Mean
1286099|NCT00179478|Secondary|The Number of New or Enlarging MRI T2 Lesions at 10 Years|These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity|10 years|Analysis restricted to those participants with MRI scans able to evaluate at 10 years|||# of new or enlarging T2 lesions||Inter-Quartile Range|Median
1286100|NCT00179478|Secondary|Number of Participants With an EDSS > 3.5 at Study Completion|The EDSS is an ordinal scale of neurological impairment in Multiple Sclerosis with a range of 0 to 10 with 0.5 increments. A score of 0 is normal and 10 is death from MS. Scores from 1 to 3.5 are considered mild impairment , 4.0 to 6.5 is moderate and greater than 6.5 is severe impairment.|10 years|Numbers of patients completing 10 year evaluations|||Participants|||Count of Participants
1286101|NCT00179478|Secondary|Annualized Relapse Rate|annualized # of relapses between years 0 and 10|10 years|Analysis only in 10 year completers|||annualized relapses per year||Standard Deviation|Mean
1286102|NCT00179478|Primary|Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years|Percent cumulative probability of developing CDMS over 10 years . CDMS was defined as the development of new visual or neurological symptoms discrete from the patients initial event with objective findings on examination.|10 years||||Percent cumulative probability||95% Confidence Interval|Number
1286103|NCT00179413|Secondary|Development of Portal Hypertension|Number of patients who develop endoscopic evidence of varices over 4 year period|4 years|The number of patients at risk include only those patients who at the baseline endoscopy had no evidence of portal hypertension or varices|||Participants|||Count of Participants
1286104|NCT00179413|Secondary|Evaluation of Safety and Tolerability of Long Term Maintenance PEG-Intron in Patients With Cirrhosis|Defined as the number of patients who discontinued therapy due to an adverse event side|4 years||||Participants|||Count of Participants
1286105|NCT00179413|Primary|Determination of the Effect of PEG-Intron 0.5mg Per kg Weekly sc Versus Colchicine 0.6mg Bid Daily on:|number of patients with a liver related outcomes including: mortality, liver transplant, variceal or portal hypertensive bleeding,Development of jaundice, ascites or encephalopathy with an increase in CPT of > 2 points and development of hepatoma|4 years||||Participants|||Count of Participants
1286106|NCT00179309|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|80 months||||Participants|||Number
1286107|NCT00179309|Primary|Progression-free Survival (PFS)|Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.|19.7 months||||Months||95% Confidence Interval|Median
1286108|NCT00179127|Secondary|Total Hospital Stay|Unable to find any data on this study. PI left Vanderbilt and there was not a publication.|Days|||||||
1286109|NCT00179127|Secondary|Time on Insulin Drip|Unable to find any data on this study. PI left Vanderbilt and there was not a publication.|Minutes|||||||
1286110|NCT00179127|Primary|Time of Acidosis Correction|Unable to find any data on this study. PI left Vanderbilt and there was not a publication.|Minutes|||||||
1286111|NCT00178919|Primary|Systolic Blood Pressure in Response to Systemic Nitric Oxide Inhibition|Systolic blood pressure at the highest tolerated dose of IV infusion of L-NMMA during autonomic nervous system blockade with trimethaphan. Trimethaphan, infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.|End of 15 minutes of infusion of L-NMMA at the highest tolerated dose||||mm Hg||Standard Deviation|Mean
1286112|NCT00178919|Primary|Change in Systolic Blood Pressure|L-NMMA (nitric oxide synthase inhibitor) was infused intravenously at different doses for 15 minutes each, after blocking the autonomic nervous system with trimethaphan. The change in systolic blood pressure at the end of the highest tolerated dose is the main outcome. Trimethaphan infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.|At the end of the highest tolerated dose of IV infusion of L-NMMA||||mm Hg||Standard Error|Mean
1286113|NCT00178841|Secondary|Pruritus Score|10-cm visual analog scale, 10= worst, 1=best|16 weeks||||units on a scale||Full Range|Mean
1286114|NCT00178841|Secondary|Quality of Life Evaluations|FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best|baseline and every 4 weeks||||units on a scale||Full Range|Mean
1286115|NCT00178841|Primary|Number of Participants With a 50% Improvement in Baseline Skin Score|mSWAT scoring. Range 0 to 400. Measured every 4 weeks.|16 weeks||||participants|||Number
1286116|NCT00178711|Other Pre-specified|Controlled Oral Word Association Test||0-12 months|||||||
1286117|NCT00178711|Other Pre-specified|Grooved Pegboard||0-12 months|||||||
1286118|NCT00178711|Other Pre-specified|Verbal Selective Reminding Test Trails B||0-12 months|||||||
1286119|NCT00178711|Other Pre-specified|Rey Osterrieth Complex Figure||0-12 months|||||||
1286120|NCT00178711|Other Pre-specified|Symbol Digit Modalities Test||0-12 months|||||||
1286121|NCT00178711|Other Pre-specified|Neurological Outcome Scale for Traumatic Brain Injury||0-12 months|||||||
1286122|NCT00178711|Other Pre-specified|Neurobehavioral Rating Scale – Revised||0-12 months|||||||
1286123|NCT00178711|Other Pre-specified|Disability Rating Scale||assessed 0-12 months|||||||
1286124|NCT00178711|Other Pre-specified|Glasgow Outcome Scale - Extended||0-12 months|||||||
1286125|NCT00178711|Primary|The Dichotomized Glasgow Outcome Scale|The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.|6 months with a window of plus or minus one month|Intention to Treat|||participants with a poor outcome|||Number
1286126|NCT00178685|Secondary|7 Day Point Prevelence (7DPP)|Seven-day point prevalence abstinence (7DPP) was assessed by asking: “Have you smoked a cigarette, even a puff, in the last 7 days?”16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users.|12 months after the intervention|820 individuals were randomized to condition, of those, 12 died during the course of the study (all deaths were found to be unrelated to the study). Final analysis number included all those randomized and excluded those who died during the study.|||participants|||Number
1286127|NCT00178685|Primary|12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.|The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.|12 months after subject completes intervention.|A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.|||participants|||Number
1286128|NCT00178633|Secondary|Change in Left Ventricular Mass|Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.|0-9 Months|broken out into 0-3months and 3-9months below|||g/m^2.7||95% Confidence Interval|Mean
1286129|NCT00178633|Secondary|Change in Tissue Doppler Diastolic Velocity|Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.|0-9 Months|Analysis broken down into 0-3 months and 3-9 months|||cm/s||95% Confidence Interval|Mean
1286130|NCT00178633|Secondary|Change in Glucose|Change in glucose. Negative values represent a decrease in glucose levels.|0-9 Months|broken out into 0-3months and 3-9months below|||mg/dL||95% Confidence Interval|Mean
1286131|NCT00178633|Primary|Change in Weight|Change in weight. Negative values represent weight loss.|0 to 9 months|broken out into 0-3months and 3-9months below|||kg||95% Confidence Interval|Mean
1286132|NCT00178503|Secondary|Mean Conners' Parent ADHD Index T Score by Week|The ADHD Index of the Conners' Parent Rating Scale-Revised (CPRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.|Measured at each dosing week of the drug trial (placebo, low, medium, high)||||Units on a scale (T-scores)||Standard Deviation|Mean
1286133|NCT00178503|Primary|Mean Continuous Performance Test (CPT)-Commission Errors by Dose|CPT is a measure of sustained attention using nonverbal stimuli (pictures). Participants are asked to click on the witch (target), which appears for 25% of the trials. Commission errors are measured by number of times they click for the non-target items.|Measured at each dosing week of the drug trial (placebo, low, medium, high)||||Total Errors||Standard Deviation|Mean
1286134|NCT00178503|Primary|Mean Conners' Teacher ADHD Index T Score by Dose|The ADHD Index of the Conners' Teacher Rating Scale-Revised (CTRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.|Measured at each dosing week of the drug trial (placebo, low, medium, high)|Although there were 24 participants who completed the trial, teacher ratings were only available for 18 participants due to 6 children being seen during the summer months.|||Units on a scale (T-scores)||Standard Deviation|Mean
1286135|NCT00178477|Primary|Tumor Motion Related to Breathing as Determined From MRI Images|"Determine the typical and maximal tumor 3D displacements over the respiratory cycle and how these values vary depending on the tumor location~Determine the reproducibility of target position over multiple breath-holds~Determine the variability across patients in respiratory-derived lesion motion and target position reproducibility over multiple breath-holds"|20 - 30 seconds|Data were not analyzed due to study termination.||||||
1286136|NCT00178464|Primary|Number of Adverse Events|Occurrence of individual adverse events and relationship to aspirin|12 months|Intention to treat|||events|||Number
1286137|NCT00178464|Secondary|# of Subjects Recruited Over Time, Screening Failures, Withdrawal Rates;Compliance (Pill Counts & Labs);Changes in Performance on Neurocognitive Tests; Changes in MRI/MRA; Changes in TCD;Incidences of Stroke, Acute Chest Crises, and Pain Crises||12 months|||||||
1286138|NCT00178464|Primary|Number of Serious Adverse Events|Occurrence of individual serious adverse events and relationship to aspirin|12 months|Intention to treat|||events|||Number
1286139|NCT00178399|Secondary|Analyze Impact of Disease Bulk and Number of Sites Involved.|Analysis or response and progression.|From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years|No data was collected for this outcome measure.||||||
1286140|NCT00178399|Secondary|Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles|Correlation of data from QOL questionnaires and blood markers.|30 months from date of registration.|No data was collected for this outcome measure.||||||
1286141|NCT00178399|Primary|Percentage of Palliatively Treated Patients With Progression-free Survival|Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.|24 months|Only palliative patients were included in this analysis|||percentage of participants|||Number
1286142|NCT00178399|Primary|Percentage of Curatively Treated Patients With Progression-free Survival|Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.|24 months|Only curative patients were included in this analysis|||percentage of participants|||Number
1286143|NCT00178256|Secondary|Median Survival|This is median survival for all subjects enrolled.|86 months||||months||Full Range|Median
1286144|NCT00178256|Primary|Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.||5 years||||Percentage subj w dose limiting toxicity|||Number
1286145|NCT00178191|Primary|Episodes/Day|number of incontinence episodes/day|9 months||||number||Standard Error|Mean
1286166|NCT00177294|Primary|Remission|Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.|Measured at Week 6 or 22||||Percentage of participants||95% Confidence Interval|Number
1286146|NCT00178178|Primary|Pain|Pain over the first three days post-operatively. This will be identified by the use of the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.|3 day||||participants that experienced pain|||Number
1286147|NCT00178126|Primary|Sitting-induced Pressure Ulcers||6 months||||participants|||Number
1286148|NCT00177970|Secondary|6) Patients' Length of Hospital Stay|During the course of the study, we expect the IVIG group compared to the placebo group will have a decrease in length of hospital stay.|during the course of the study|No results available record destroyed due to age of study. no publications||||||
1286149|NCT00177970|Secondary|5) Normalization of Body Temperature During a 24 Hour Period|During the course of the study, we expect the IVIG group compared to the placebo group will have a normal body temperature of 98.6 F.|during the course of the study|No results available record destroyed due to age of study. no publications||||||
1286150|NCT00177970|Secondary|4) Normalization of Neutrophil Count on CBC With Diff.|During the course of the study, we expect the IVIG group compared to the placebo group will have normalization of neutrophil count (1.6-6.7)on CBC with diff.|during the course of the study|No results available record destroyed due to age of study. no publications||||||
1286151|NCT00177970|Secondary|3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea|A correlation will occur between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea.|during the course of the study|No results available record destroyed due to age of study. no publications||||||
1286152|NCT00177970|Secondary|2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea|The quantity of anti-C. difficile antibodies with improve in relationship with recovery|during the course of the study|No results available record destroyed due to age of study. no publications||||||
1286153|NCT00177970|Secondary|1) 75% Reduction in Abdominal Pain/Tenderness|During the course of the study, we expect the IVIG group compared to the placebo group will a 75% reduction in abdominal pain/tenderness|during the course of the study|No results available record destroyed due to age of study. no publications||||||
1286154|NCT00177970|Primary|2) Decrease of Number of Loose Stools to <3 Per Day Following Treatment|During the course of the study, we expect the IVIG group compared to the placebo group will have fewer number of stools per day (<3 per day).|during the course of the study|No results available record destroyed due to age of study. no publications||||||
1286155|NCT00177970|Primary|1) Normalization of WBC's|During the course of the study, we expect the IVIG group compared to the placebo group will have a normal WBC count 3.8-10.0/CMM|during the course of the study|No results available record destroyed due to age of study. no publications||||||
1286156|NCT00177866|Secondary|Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment|No results or publication, data destroyed due to age of study.|completion of all study participants|||||||
1286157|NCT00177866|Primary|Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment|Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment|completion of all study participants|No results or publication, data destroyed due to age of study.||||||
1286158|NCT00177671|Post-Hoc|Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.|Conversion to dementia was ascertained by the University of Pittsburgh Alzheimer Disease Research Center (ADRC), using data on neuropsychological performance and IADL functioning, as well as other relevant clinical data. Diagnoses were made according to National Alzheimer Coordinating Center criteria.|2 year|This is the percent of participants with mild cognitive impairment (MCI) in each arm of the study.|||Percent of Participants|||Number
1286159|NCT00177671|Primary|Number of Participants With Recurrence of Major Depression|Recurrence of major depressive episodes as determined by SCID/DSM IV: two weeks of low mood and/or anhedonia, together with at least five of the following symptoms: suicidal ideation, low energy, sleep disturbance, appetite disturbance, psychic anxiety or somatic anxiety. In addition, a diagnosis of major depression requires evidence of distress or impairment.|2 years||||participants||95% Confidence Interval|Number
1286160|NCT00177671|Primary|Cognitive Instrumental Activities of Daily Living (IADL)|The PASS (a performance-based assessment of instrumental activities of daily living)generates a composite measure of 13 cognitive IADL items capturing performance on activities such as shopping, bill paying, medication management, and home safety. We report the percentage of subjects at each assessment point adjudged to have independent functioning. This was determined by a clinician rater observing subjects perform each task and rating them according to predetermined criteria on a 4 point scale, ranging from 0 (unable) to 3 (independent).|baseline, year 1 and year 2|Some participants refused this testing.|||Percentage of participants|||Number
1286161|NCT00177671|Primary|Global Cognitive Performance|Cognitive performance was assessed with 17 well established and validated individual tests measuring multiple domains. We transformed raw scores for individual tests into Z-scores using the baseline distribution of a non-depressed, cognitively normal, older adult comparison group (N=36)of similar age, education, and medical health recruited concurrently with the depressed participants. These Z-scores were averaged within each neuropsychological area to produce domain scores and then averaged over all 17 tests to calculate a global cognition performance score.|Measured at baseline and Years 1 and 2 in maintenance||||Z-score||Standard Deviation|Mean
1286162|NCT00177307|Secondary|1-, 2-, and 3-year Overall Survival|Probability of being alive at 1-, 2-, and 3-years from start of protocol therapy|Up to 40 months||||percent chance|||Number
1286163|NCT00177307|Secondary|Overall Survival|time from start of protocol therapy until death from any cause|Up to 40 months||||Months||95% Confidence Interval|Median
1286164|NCT00177307|Secondary|Response Rate (RR)|Percentage of partial responses (PR) + complete responses (CR).|Up to 27 months||||percentage of participants|||Number
1286165|NCT00177307|Primary|Progression Free Survival (PFS)|time from start of protocol therapy until objective tumor progression or death|Up to 27 Months||||Months||95% Confidence Interval|Median
1286169|NCT00177216|Primary|Change in Diary Sleep Efficiency|The change in self-report sleep efficiency calculated from 7-day sleep diary (DSE): Sleep efficiency is the percent of (time spent asleep divided by the amount of time between good night time and final awakening). It ranges from 0 (no sleep at all) to 100 (asleep the second your head hits the pillow until you wake up in the morning and get out of bed). Participants report the time they go to bed, how long they think it takes them to fall asleep, how many minutes they are awake during the night, and then what time they finally wake up in the morning. These values are used to calculate the diary sleep efficiency for each night and then we averaged these across the 7 days of diary collected pre and post treatment. The values below are post treatment DSE minus pre treatment DSE. A positive number means that the DSE was higher (better) post treatment.|post treatment minus baseline. This averaged 69 days.|The number of subjects with sleep diaries at baseline and after at least 5 weeks of treatment. Not all of these participants 'completed' the protocol|||diff score of diary Sleep Efficiency||Standard Deviation|Mean
1286170|NCT00177216|Primary|Change in Pittsburgh Sleep Quality Index|Self-report measure of sleep quality developed at University of Pittsburgh by Daniel J. Buysse, M.D. The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 5 weeks of treatment in one of the three arms, minus the baseline total score. A negative score means that the sleep of the participant improved.|post treatment minus baseline assessment battery. This averaged 100 days.|Number of subjects who had total PSQI scores after at least 5 weeks of treatment. The PSQI requires that all questions be answered for a total score to be calculated. This analysis includes participants who did not complete the protocol and also omits those who has missing total scores due to missing items on the PSQI|||difference score of PSQI total||Standard Deviation|Mean
1286171|NCT00177216|Secondary|Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint|Change in PSG Sleep Efficiency (SE) between post-treatment and baseline: Sleep efficiency is the percent of time spent asleep divided by the total sleep recording period in the sleep lab. This value is calculated using the results of the polysomnographic sleep study. It ranges from 0 (no sleep at all) to 100 (asleep the second the sleep recording starts (GNT) until the sleep recording ends (GMT) in the morning). The values below are post treatment SE minus pre treatment SE. A positive number means that the SE was higher (better) post treatment.|post treatment minus baseline PSG sleep studies. This averaged 70 days|Number of subjects who had polysomnography at Week 9 and at pretreatment. Some of the participants who 'completed' the protocol did not have follow up sleep studies.|||difference score for SE||Standard Deviation|Mean
1286172|NCT00177164|Secondary|Number of Participants With Treatment Emergent Hyperlipidemia|Number of participants with Hyperlipidemia as determined by safety labs|from baseline to end of 15 months|patients with bipolar disorder|||participants|||Number
1286173|NCT00177164|Secondary|Number of Participants With Treatment - Emergent Hyperglycemia|Number of participants with hyperglycemia based on safety labs|from baseline to end of 15 months|patients with bipolar disorder|||participants|||Number
1286174|NCT00177164|Secondary|BMI|BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups|baseline to end of 15 months|Patients with bipolar disorder|||kg / m^2||Standard Deviation|Mean
1286175|NCT00177164|Primary|Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.||Upto 15 months|2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.|||Number of clinical events||Standard Deviation|Mean
1286176|NCT00176917|Secondary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (aGVHD).|Toxicity (undesireable effect) of this stem cell transplant preparative regimen due to acute graft-versus-host disease.|Day 100 Post Transplant||||Participants|||Number
1286177|NCT00176917|Secondary|Number of Patients Who Failed Engraftment.|Toxicity (undesireable effect) of hematologic donor cell engraftment is determined by failure to engraft at Day 42.|Day 42 Post Transplant|1 patient of 41 failed engraftment - per protocol.|||Participants|||Number
1286178|NCT00176917|Secondary|Number of Patients Surviving on Study|Number of patients surviving (alive) at specified timepoints.|at 100 days, 1 year, and 3 years post transplant|Day 100 and 1 Year timepoints include all 41 patients. Year 3 includes 36 patients (5 pts not yet at followup timepoint.)|||Participants|||Number
1286179|NCT00176917|Primary|Mean Percentage of Donor Cells in Study Population (Chimerism).|Donor-derived engraftment determined by restriction fragment length polymorphism (RFLP).|at 21 days, 42 days, 60 days, 100 days, 6 months, and 1 year|Day 21 (24 patients included), Day 42 (15 pts), Day 60 (29 pts), Day 100 (25 pts), 6 Months (18 pts), 1 Year (16 pts).|||Percentage||Standard Deviation|Mean
1286180|NCT00176904|Secondary|Number of Patients With Chronic Graft-Versus-Host Disease|Number of patients who exhibited chronic graft-versus-host disease by 1 Year post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Chronic GVHD is an extension of this syndrome.|1 Year Post Transplant||||Participants|||Number
1286181|NCT00176904|Secondary|Number of Patients With Grade III-IV Acute Graft-Versus-Host Disease|Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening.|Day 100||||Participants|||Number
1286182|NCT00176904|Secondary|Number of Patients With Grade II-IV Acute Graft-Versus-Host Disease|Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening.|Day 100||||Participants|||Number
1286183|NCT00176904|Secondary|Overall Donor Engraftment|Number of patients with full donor chimerism (state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease) by Day 100 post-transplant of at least 90%.|Day 100|1 Patient not included due to early death (before day 40).|||Participants|||Number
1286187|NCT00176878|Secondary|Number of Patients With Grade 2-4 Acute Graft Versus Host Disease|Number of patients with Grade 2, 3 and 4 Acute (normally observed within the first 100 days) Graft Versus Host Disease. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of 1 to a high of 4. Patients with grade IV GVHD usually have a poor prognosis. Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening.|100 Days||||Participants|||Number
1286188|NCT00176878|Secondary|Number of Patients With Succcessful Engraftment After Transplantation|"Number of patients who received non-genotypic identical marrow or cord blood cells using a non-myeloablative preparative regimen and exhibited engraftment at Day 42."|42 Days||||Participants|||Number
1286189|NCT00176878|Secondary|Number of Patients Alive at Three Years (Survival)|Number of subjects who survived 3 years post-transplant.|3 years||||Participants|||Number
1286190|NCT00176878|Primary|Number of Patients Alive (Survival) at 2 Years|Calculated from day 1 of transplant to last contact.|2 years||||Participants|||Number
1286191|NCT00176865|Secondary|Compare Quality of Life (QOL)||Pretransplant, 1 year, 2 years and 5 years|PI made decision after IRB approval, but before opening the study to accrual, to not collect QOL data .||||||
1286192|NCT00176865|Secondary|Number of Subjects Alive at One Year||Day 365||||participants|||Number
1286193|NCT00176865|Secondary|Number of Subjects Alive at 100 Days||Day 100||||participants|||Number
1286194|NCT00176865|Secondary|Incidence of Chronic Graft Versus Host Disease (cGVHD)|Chronic graft versus host disease (cGVHD) is a reaction which typically develops 3 to 6 months after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs.|6 months and 1 year||||participants|||Number
1286195|NCT00176865|Secondary|Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD)|Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.|Day 100||||participants|||Number
1286196|NCT00176865|Secondary|Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD)|Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.|Day 100||||participants|||Number
1286197|NCT00176865|Secondary|Percentage of Donor Chimerism at 365 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 365|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.~Arm 3: 2 of 6 patients not evaluable due to early death."|||percentage of donor cells||Standard Deviation|Mean
1286198|NCT00176865|Secondary|Percentage of Donor Chimerism at 180 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 180|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.~Arm 3: 2 of 6 patients not evaluable due to early death."|||percentage of donor cells||Standard Deviation|Mean
1286199|NCT00176865|Secondary|Percentage of Donor Chimerism at 100 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 100|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.~Arm 3: 2 of 6 patients not evaluable due to early death."|||percentage of donor cells||Standard Deviation|Mean
1286200|NCT00176865|Primary|Number of Subjects With Mixed Chimerism|>10% Donor Cells at Day 100|Day 100|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.~Arm 3: 2 of 6 patients not evaluable due to early death."|||participants|||Number
1286201|NCT00176852|Secondary|Disease Free Survival|Number of patients alive without disease 1 year after transplant.|1 year||||Participants|||Count of Participants
1286202|NCT00176852|Secondary|Disease Free Survival|Number of patients alive without disease 100 days after transplant.|100 days||||Participants|||Count of Participants
1286203|NCT00176852|Secondary|Overall Survival|Number of patients alive 1 year after transplant.|1 year||||Participants|||Count of Participants
1286204|NCT00176852|Secondary|Overall Survival|Number of patients alive 100 days after transplant.|100 days||||Participants|||Count of Participants
1286205|NCT00176852|Secondary|Determine the Concentration of Campath in the Serum||Day 0|The Principal Investigator removed this as a study objective and therefore Campath concentrations were not collected.||||||
1286206|NCT00176852|Secondary|Determine Physical Characteristics and Biologic Effects of Mixed Populations of Donor and Host Red Blood Cells||During study|The Principal Investigator removed this as a study objective.||||||
1286207|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|5 years|The 5 year time point will not be ready for analysis until 2019.||||||
1286208|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|2 years|Two of the 14 patients treated on Arm A2 died before 2 years and 2 failed their 2 year clinic appointment.|||units on a scale||Full Range|Median
1286209|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|1 year|Two of the 14 patients treated on Arm A2 died before 1 year.|||units on a scale||Full Range|Median
1286210|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|pre-transplant||||units on a scale||Full Range|Median
1286240|NCT00176631|Secondary|Proportion of Patients With a Decrease in BCL-2 Levels in PBMC and in the Degree of Plasma ER Receptor, Between Patients Who Responded to Treatment and Patients Who Did Not||7 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
1286211|NCT00176852|Secondary|The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)|The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant.|1 year||||Participants|||Count of Participants
1286212|NCT00176852|Secondary|The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)|The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant.|6 months||||Participants|||Count of Participants
1286213|NCT00176852|Secondary|The Incidence of Grade 3-4 Acute Graft Versus Host Disease (Acute GVHD)|The number of patients who experienced grades 3-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. IGrades 3-4 equate to moderate to severe disease. Symptoms typically appear within weeks after transplant.|100 days||||Participants|||Count of Participants
1286214|NCT00176852|Secondary|The Incidence of Grade 2-4 Acute Graft Versus Host Disease (Acute GVHD)|The number of patients who experienced grades 2-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. Grades 2-4 equate to mild to severe disease. Symptoms typically appear within weeks after transplant.|100 days||||Participants|||Count of Participants
1286215|NCT00176852|Secondary|The Incidence of Chimerism at 1 Year|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|1 year|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 1 year.|||Participants|||Count of Participants
1286216|NCT00176852|Secondary|The Incidence of Chimerism at 6 Months|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|6 months|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 6 months.|||Participants|||Count of Participants
1286217|NCT00176852|Secondary|The Incidence of Chimerism at 100 Days|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|100 days|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 100 days.|||Participants|||Count of Participants
1286218|NCT00176852|Primary|Number of Patients Who Experienced Grade 3-5 Treatment Related Toxicity|In general, grade 3 equates to moderate, grade 4 to severe and grade 5 to death.|1 year||||Participants|||Count of Participants
1286219|NCT00176839|Secondary|Incidence of Relapse|Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year||||participants|||Number
1286220|NCT00176839|Secondary|Incidence of Regimen-related Toxicity 100 Days Post Transplant|Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|100 days post-transplant||||participants|||Number
1286221|NCT00176839|Secondary|Incidence Chronic Graft-versus-host Disease (GVHD)|Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year||||participants|||Number
1286222|NCT00176839|Secondary|Incidence of Acute Graft-versus-host Disease (GVHD)|Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|100 days post-transplant||||participants|||Number
1286223|NCT00176839|Secondary|Probability of Engraftment|Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies..|1 year||||participants|||Number
1286224|NCT00176839|Primary|Probability of Long-term Disease-free Survival (DFS)|Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year||||participants|||Number
1286225|NCT00176826|Secondary|Number of Patients Surviving (Disease-free)||3 years||||participants|||Number
1286226|NCT00176826|Secondary|Number of Patients With III-IV Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant||||participants|||Number
1286227|NCT00176826|Secondary|Number of Patients With Graft Failure||Day 100 Post transplant||||participants|||Number
1286228|NCT00176826|Secondary|Number of Patients With Grade II-IV Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant||||participants|||Number
1286229|NCT00176826|Secondary|Number of Patients Surviving (Disease-free)||1 year||||participants|||Number
1286230|NCT00176826|Secondary|Number of Patients With Treatment Related Mortality.||Day 100 Post Transplant||||participants|||Number
1286231|NCT00176826|Primary|Time to Transplant Engraftment||Day 100 Post Transplant||||days||Standard Deviation|Mean
1286232|NCT00176800|Secondary|Percentage of Patients That Require Dose Modification Due to Toxicity||8 years||||percentage of patients|||Number
1286233|NCT00176800|Secondary|Median Overall Survival Time|To measure the survival time in patients treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.|8 years||||months||95% Confidence Interval|Median
1286234|NCT00176800|Primary|Median Recurrence Free Survival Time|To measure the time recurrence in patients with esophageal cancer treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.|8 years||||months||95% Confidence Interval|Median
1286235|NCT00176644|Secondary|To Assess the Plateau Level of Estradiol That is Attained With the Dose of 0.4mg/Day Given Via Transdermal Estradiol Patch and in Addition, Assess the Response on Testosterone in the Androgen Resistant Population.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).||||||
1286236|NCT00176644|Secondary|To Evaluate Time to Progression.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).||||||
1286241|NCT00176631|Primary|Percentage of Patients With PSA Response|Decline from baseline value by > 50%, or normalization of PSA (defined as PSA less than 0.2 ng/ml), confirmed by a second measurement at least 1 or more weeks later.|7 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
1286242|NCT00176605|Secondary|Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.|All patients who receive one dose of protocol therapy will be evaluable for toxicity. A total of 15 patients received at least one dose of protocol therapy. Adverse events are described in Adverse Event section.|5 years|No subjects experienced serious adverse events related to the intervention.|||participants|||Number
1286243|NCT00176605|Primary|PSA Response Rate|The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.|5 years||||percentage of participants|||Number
1286244|NCT00176501|Secondary|Rate of Graft-vs-host Disease||5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.||||||
1286245|NCT00176501|Secondary|Rate and Kinetics of Clinical/Radiological Response||5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.||||||
1286246|NCT00176501|Primary|Response Rate|With regard to responses, this trial will use a two-stage Simon’s design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.|5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.||||||
1286247|NCT00176488|Secondary|Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4).||10 years|Study was closed prematurely and insufficient data was collected.||||||
1286248|NCT00176488|Secondary|Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells.||10 years|Study was closed prematurely and insufficient data was collected.||||||
1286249|NCT00176488|Primary|Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer.||10 years|Study was closed prematurely and insufficient data was collected.||||||
1286250|NCT00176462|Secondary|To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis||5 years|We did not analyze this outcome measure. The laboratory analysis was not performed. The Principal Investigator left the institution.||||||
1286251|NCT00176462|Primary|Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years|This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.|5 years|Number of high risk ALL patients treated.|||percentage of participants|||Number
1286252|NCT00176436|Secondary|Chemistry Panel||baseline, 10 weeks and 24 weeks|||||||
1286253|NCT00176436|Secondary|Vital Signs||Weekly for 24 weeks|||||||
1286254|NCT00176436|Secondary|Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.||24 weeks|||||||
1286255|NCT00176436|Primary|Change From Baseline in Weight|Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.|Weekly for 24 weeks||||kilograms||Standard Deviation|Mean
1286256|NCT00176306|Primary|Plasma Concentration of Levofloxacin|A peripheral intravenous catheter will be placed in each arm for drug administration and serial blood sampling. Pre-existing intravenous access will be utilized when possible. Subjects will rest in a supine position while receiving a 750 mg intravenous dose of levofloxacin over 90 minutes. Serial blood samples will be obtained 1.5, 3, 4, 5, 8, 12, and 24 hours after the beginning of administration of levofloxacin. Data will be presented as mean area under the curve +/- standard deviation.|24 hours|pilot study|||mg/L*hr||Standard Deviation|Mean
1286257|NCT00176254|Secondary|5 Year Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|5 years||||participants|||Number
1286258|NCT00176254|Secondary|5 Year Disease-specific Survival|Outcome is calculated from the time of enrollment to the time of death due to disease under study or survival to 5 years without death from disease under study, whichever occurs first.The 5-year rates of disease-specific survival were calculated using the Kaplan-Meier method.|5 years||||participants|||Number
1286259|NCT00176254|Secondary|5 Year Overall Survival Rates||5 years post study||||participants|||Number
1286260|NCT00176254|Secondary|Frequency of Severe (>/= Grade 3) Toxicities||assessed starting on day 1 through study day 58 or until toxicity resolves|Intent to Treat|||adverse events|||Number
1286261|NCT00176254|Primary|Response Rate to Induction Chemotherapy Prior to Definitive Therapy (Surgery or Radiation)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|assessed pre-study and once between days 36-57||||participants|||Number
1288804|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg|72-hour fasting Day 3 Leptin dose 0.01 mg/kg|3 DAY||||NG/ML||Standard Deviation|Mean
1286262|NCT00176228|Secondary|Child Depression Rating Scale (CDRS-R)|Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children’s Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.|weekly at baseline and each week during osing (8 weeks) and dose stabilized phase (6 weeks)||||units on a scale||Standard Deviation|Mean
1286263|NCT00176228|Primary|Young Mania Rating Scale (YMRS),|This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient’s subjective report of his or her condition over the previous forty-eight hours and the clinician’s behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.|Weekly during the 8 week lamotrigine dose titration and 6 week full dose phase.||||units on a scale||Standard Deviation|Mean
1286264|NCT00176202|Secondary|Clinical Global Improvement in Bipolar Disorder Overall (CGI-BP Overall)|Severity of Illness and Global Improvement are rated on a 7-point scale by the clinician. In addition to rating the overall illness with the CGI-BP, severity and improvement are considered on various other dimensions such as mania, depression, attention deficit/hyperactivity, psychosis, aggression and sleep difficulties. Score of 1, 2 and 3 would mean there is clinically observed symptom improvement where 1 is the best outcome than 2 or 3. The point 4 is the point where the subject presents at baseline of that specific individual. If they become worse on clinical symptoms, they are rated as 5, 6 or 7 where 7 is worse than 5.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).||||units on a scale||Standard Deviation|Mean
1286265|NCT00176202|Secondary|Child Mania Rating Scale (CMRS)|Child Mania rating scale is a parent rated measure to screen for symptoms of mania. It includes 21 items reflecting the DSM-IV criteria for a manic episode. Each item is answered on a four-point Likert type scale anchored by 0 (Never/Rare), 1 (Sometimes), 2 (Often), and 3 (Very Often). Maximum score possible is 63. Score higher than 20 is considered clinically significant, and this is a dimensional score of manic severity.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).||||units on scale||Standard Deviation|Mean
1286266|NCT00176202|Secondary|Child Depression Rating Scale- Revised (CDRS-R)|Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children’s Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation are measured in this study to illustrate outcome at baseline and when the subject ended the study.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).||||units on a scale||Standard Deviation|Mean
1286267|NCT00176202|Primary|Young Mania Rating Scale (YMRS)|This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. We show the mean and standard deviation at week 0 and 6.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|Inclusion criteria were a DSM-IV diagnosis of bipolar disorder Type I (mixed or manic episode); 8 to 18 years old; and medication free or currently clinically unstable on medication, justifying termination of the ineffective regimen.|||units on a scale||Standard Deviation|Mean
1286268|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.|||units on a scale||Standard Deviation|Mean
1286269|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.|||units on a scale||Standard Deviation|Mean
1286270|NCT00175877|Secondary|Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit|Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.|||percentage of participants|||Number
1286271|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.|||units on a scale||Standard Deviation|Mean
1286272|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness|Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 838 are included in this analysis. Data not available for 8 subjects.|||hours||Standard Deviation|Mean
1286273|NCT00175877|Secondary|Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire – Disability Index (HAQ-DI) Total Score|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 824 are included in this analysis. Data not available for 22 subjects.|||units on a scale||Standard Deviation|Mean
1286274|NCT00175877|Secondary|Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 661 are included in this analysis. Data not available for 185 subjects.|||units on a scale||Standard Deviation|Mean
1286275|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal|The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.|||percentage of participants||95% Confidence Interval|Number
1286276|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240|The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.|||percentage of participants||95% Confidence Interval|Number
1286277|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192|The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.|||percentage of participants||95% Confidence Interval|Number
1286278|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144|The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.|||percentage of participants||95% Confidence Interval|Number
1286279|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96|The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.|||percentage of participants||95% Confidence Interval|Number
1286280|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48|The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.|||percentage of participants||95% Confidence Interval|Number
1286281|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal|The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.|||percentage of participants||95% Confidence Interval|Number
1286282|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240|The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.|||percentage of participants||95% Confidence Interval|Number
1286283|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192|The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.|||percentage of participants||95% Confidence Interval|Number
1286284|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144|The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.|||percentage of participants||95% Confidence Interval|Number
1286285|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96|The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.|||percentage of participants||95% Confidence Interval|Number
1286309|NCT00175019|Secondary|Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit.|The number of tophi were counted at baseline and final visits. The percent change from baseline in the number of tophi to the final visit was summarized.|Final Visit (up to 40 months).|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline who also had their tophi counted while receiving their final stable treatment were included in the analysis.|||percent change from baseline||Standard Deviation|Mean
1286286|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48|The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.|||percentage of participants||95% Confidence Interval|Number
1286287|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal|The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.|||percentage of participants||95% Confidence Interval|Number
1286288|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240|The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.|||percentage of participants||95% Confidence Interval|Number
1286289|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192|The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.|||percentage of participants||95% Confidence Interval|Number
1286290|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144|The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.|||percentage of participants||95% Confidence Interval|Number
1286291|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96|The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.|||percentage of participants||95% Confidence Interval|Number
1286292|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48|The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.|||percentage of participants||95% Confidence Interval|Number
1286293|NCT00175877|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study|An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.|From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)|Safety Set|||percentage of participants|||Number
1286294|NCT00175877|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years|"A SAE is any untoward medical occurrence that at any dose:~Results in death~Is life-threatening~Requires in patient hospitalisation or prolongation of existing hospitalisation~Results in persistent or significant disability/incapacity, or~Is a congenital anomaly or birth defect~Is as infection that requires treatment parenteral antibiotics~Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above~First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 7 years)|Safety Set|||percentage of participants|||Number
1286295|NCT00175877|Primary|Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 7 years)|Safety Set|||percentage of participants|||Number
1286296|NCT00175825|Primary|Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period|Calculated as 7-day partial onset seizure frequency.|During the 7-week Treatment Period||||Seizures per week||Inter-Quartile Range|Median
1286297|NCT00175825|Secondary|Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period|Number of days to first, fifth, and tenth seizure after baseline.|During the 7-week Treatment Period||||days||95% Confidence Interval|Median
1286298|NCT00175825|Secondary|Number of Seizure-free Days Per 4 Weeks|A day was considered seizure-free, if no seizure was reported during 24 hours.|Baseline, during the 7-week Treatment Period||||Days/4 Weeks||Inter-Quartile Range|Median
1286299|NCT00175825|Secondary|Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period|A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.|During the 7-week Treatment Period||||percentage of participants|||Number
1286300|NCT00175825|Secondary|Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period|Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.|During the 7-week Treatment Period||||percentage of participants|||Number
1286301|NCT00175825|Secondary|Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period|A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.|During the 7-week Treatment Period||||percentage of participants|||Number
1286302|NCT00175825|Secondary|Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period|Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.|During the 7-week Treatment Period||||percentage of change||Inter-Quartile Range|Median
1286303|NCT00175825|Secondary|Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period|Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.|During the 7-week Treatment Period||||seizures per week||Inter-Quartile Range|Median
1286304|NCT00175825|Secondary|Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period|Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.|During the 7-week Treatment Period||||seizures per week||Inter-Quartile Range|Median
1286305|NCT00175825|Secondary|Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period|Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.|During the 7-week Treatment Period||||seizures per week||Inter-Quartile Range|Median
1286306|NCT00175825|Secondary|Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period|Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.|Baseline, during the 7-week Treatment Period||||percentage of change||Inter-Quartile Range|Median
1286307|NCT00175019|Secondary|Percentage of Subjects Requiring Treatment for Gout Flare After Month 12.|The percentage of subjects requiring treatment for gout flare after the first 12 months of final stable treatment was summarized.|After Month 12 to Final Visit|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.|||percentage of subjects|||Number
1286308|NCT00175019|Secondary|Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12.|The percentage of subjects requiring treatment for gout flare during the first twelve months of final stable treatment was summarized.|Month 12|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.|||percentage of subjects|||Number
1286841|NCT00167180|Secondary|Number of Participants With Complete Remission|In complete remission, all signs and symptoms of cancer that can be detected with modern technology have disappeared, although cancer still may be in the body.|one year||||Participants|||Count of Participants
1286310|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and final visit. The percent change from baseline in primary tophus size to the final visit was summarized.|Final Visit (up to 40 months).|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured while receiving their final stable treatment were included in the analysis.|||percent change from baseline||Inter-Quartile Range|Median
1286311|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 36 visit. The percent change from baseline in primary tophus size to the Month 36 visit was summarized.|Month 36|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 36 visit were included in the analysis.|||percent change from baseline||Inter-Quartile Range|Median
1286312|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 24 visit. The percent change from baseline in primary tophus size to the Month 24 visit was summarized.|Month 24|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 24 visit were included in the analysis.|||percent change from baseline||Inter-Quartile Range|Median
1286313|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.|The percentage of subjects whose serum urate was <6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.|Last Visit on treatment (up to 40 months).|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.|||percentage of subjects|||Number
1286314|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.|Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.|Month 36|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 36 visit and who had not changed from their initial treatment were included in the analysis.|||percentage of subjects|||Number
1286315|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.|Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.|Month 24|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 24 visit and who had not changed from their initial treatment were included in the analysis.|||percentage of subjects|||Number
1286316|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.|Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.|Month 12|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 12 visit and who had not changed from their initial treatment were included in the analysis.|||percentage of subjects|||Number
1286317|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.|Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 1 visit was summarized.|Month 1|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 1 visit and who had not changed from their initial treatment were included in the analysis.|||percentage of subjects|||Number
1286318|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at the Month 12 visit. The percent change from baseline in primary tophus size to the Month 12 visit was summarized.|Month 12|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 12 visit were included in the analysis.|||percent change from baseline||Inter-Quartile Range|Median
1286319|NCT00175019|Secondary|Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment.|The percent change in serum urate from baseline to the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.|Last Visit on treatment (up to 40 months).|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.|||percent change from baseline||Standard Deviation|Mean
1286320|NCT00175006|Primary|Average Percent Difference in Area Between Raters|Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.|Visit 1 (Day 1 ) and Visit 2 (Day 6-11)|Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled.|||mm²||Standard Deviation|Mean
1286391|NCT00174447|Secondary|Number of Participants With Scores on Patient Preference Scale (PPS)|Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.|Baseline, up to 5 years (End of Study)|ITT|||participants|||Number
1286321|NCT00175006|Primary|Average Percent Difference in Area Between Visits|The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled. Change in tophus size over 10 days was not expected.|||mm²||Standard Deviation|Mean
1286322|NCT00174967|Secondary|Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.|24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.|Baseline and Day 28.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. Missing data was not imputed|||percent change from baseline||Standard Deviation|Mean
1286323|NCT00174967|Secondary|Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.|Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.|Baseline and Any visit (Day 7, 14, 21,or 28)|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL.|||percent change from baseline||Standard Deviation|Mean
1286324|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.|Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.|Baseline and Day 28.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percent change from baseline||Standard Deviation|Mean
1286325|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit|Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.|Baseline and Day 21.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percent change from baseline||Standard Deviation|Mean
1286326|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.|Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.|Baseline and Day 14.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percent change from baseline||Standard Deviation|Mean
1286327|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.|Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.|Baseline and Day 7.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percent change from baseline||Standard Deviation|Mean
1286328|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.|Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized.|Day 21.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percentage of subjects|||Number
1286329|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.|Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized.|Day 14.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percentage of subjects|||Number
1286330|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.|Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized.|Day 7.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percentage of subjects|||Number
1286331|NCT00174967|Primary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.|Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 28 visit was summarized.|Day 28.|Analysis performed on intent-to-treat (ITT) subjects, defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no postbaseline visits were available.|||percentage of subjects|||Number
1286332|NCT00174954|Primary|Measurement of Tophi by MRI - Difference in Volume Between Readers|Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Analysis was performed on the subjects with MRI tophus volume measurements from both readers at the same visit.|||cm³||Standard Deviation|Mean
1288805|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg|72-hour fasting Day 3 Leptin dose 0.01 mg/kg|3 DAY||||HR||Standard Deviation|Mean
1286333|NCT00174954|Primary|Measurement of Tophi by MRI - Difference in Volument Between Visits|Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Analysis was performed on the subjects with MRI tophus volume measurements at both visits from the same reader. Change in tophus size over 10 days was not expected.|||centimeters³ (cm³)||Standard Deviation|Mean
1286334|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Final Visit.|The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Baseline and Last Visit on treatment (up to 66 months).|Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
1286335|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.|The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.|Baseline and Month 60|Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
1286336|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.|Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.|Baseline and Month 48|Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
1286337|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.|Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.|Baseline and Month 36|Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
1286338|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.|Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.|Baseline and Month 24|Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
1286339|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.|Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.|Baseline and Month 18|Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
1286340|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.|Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.|Baseline and Month 12|Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects||Standard Deviation|Mean
1286341|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 66 months).|Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
1286342|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.|Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized.|Month 60|Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
1286343|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.|Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.|Month 48|Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
1286344|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.|Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.|Month 36|Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
1286602|NCT00168844|Secondary|Weekly Mean Morning Pre-dose PEFRs|Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Litres/minute||Standard Error|Mean
1286345|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.|Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.|Month 24|Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
1286346|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.|Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized.|Month 18|Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
1286347|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.|Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.|Month 12|Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
1286348|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.|Baseline and Month 6|Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
1286349|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.|Month 6|Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
1286350|NCT00174915|Secondary|Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.|Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.|Weeks 8 through 28|Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 28.|||percentage of subjects|||Number
1286351|NCT00174915|Secondary|Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit|Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.|Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
1286352|NCT00174915|Secondary|Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.|Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
1286353|NCT00174915|Secondary|Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.|Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
1286354|NCT00174915|Secondary|Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
1286355|NCT00174915|Secondary|Percent Change From Baseline in Serum Urate Levels at Final Visit|The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as [(Final visit - baseline levels)/baseline]*100. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percent change||Standard Deviation|Mean
1286630|NCT00168844|Secondary|Change From Baseline in Neutrophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1286356|NCT00174915|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 28.|Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(Week 28 - baseline levels)/baseline]*100 and summarized.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percent change||Standard Deviation|Mean
1286357|NCT00174915|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected and may have differed by subject.|Final Visit (up to 28 weeks).|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
1286358|NCT00174915|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28|Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.|Week 28|Analysis was performed on intend to treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
1286359|NCT00174915|Primary|Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).|Each subject’s serum urate at the last 3 visits determined the subject’s response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.|Last 3 visits (any last 3 visits up to week 28)|Analysis was performed on all randomized subjects who took at least 1 dose of study drug and had a baseline serum urate ≥8.0 mg/dL. If subject prematurely discontinued from study before at least 3 serum urate levels were obtained, subject was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used.|||Percentage of subjects|||Number
1286360|NCT00174785|Other Pre-specified|Adjudicated Cardiovascular Death|The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population|||participants|||Number
1286361|NCT00174785|Secondary|Cardiovascular Death|The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population|||participants|||Number
1286362|NCT00174785|Secondary|First Hospitalization for Cardiovascular Reason|The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population|||participants|||Number
1286363|NCT00174785|Secondary|Death From Any Cause|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population|||participants|||Number
1286364|NCT00174785|Primary|First Hospitalization for Cardiovascular Reason or Death From Any Cause|The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|"All efficacy analyses were performed on the all randomized patients population including all patients randomized irrespective of whether the patient actually received any drug or complied with the study protocol."|||participants|||Number
1286365|NCT00174460|Secondary|Growth Curve Comparison Based on Height: Control Arm|Growth curve comparison with height in centimeters as the dependent variable.|Month 36|FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.|||centimeters||Standard Error|Least Squares Mean
1286366|NCT00174460|Secondary|Growth Curve Comparison Based on Height|Growth curve comparison with height in centimeters as the dependent variable.|Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.|||centimeters||Standard Error|Least Squares Mean
1286367|NCT00174460|Secondary|Growth Curve Comparison Based on Height SDS: Control Arm|Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference). Control Arm final visit=Month 36.|Month 36|FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.|||centimeters||Standard Error|Least Squares Mean
1286368|NCT00174460|Secondary|Growth Curve Comparison Based on Height SDS|Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.|||centimeters||Standard Error|Least Squares Mean
1286392|NCT00174447|Primary|Change From Baseline in CGI-I at End of Study (up to 5 Years)|CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.|Baseline, up to 5 years (End of Study [LOCF])|ITT. LOCF.|||score on a scale||Standard Deviation|Mean
1286369|NCT00174460|Secondary|Number of Participants With Change in Insulin Sensitivity: Control Arm|Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Control Arm=Month 36). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.|Baseline, Month 36|FAS; Control group received Somatropin from Month 12 onwards.|||participants|||Number
1286370|NCT00174460|Secondary|Number of Participants With Change in Insulin Sensitivity: Somatropin|Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Somatropin treatment group=Month 24). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.|Baseline, Month 24|FAS|||participants|||Number
1286371|NCT00174460|Secondary|Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years|Muscle strength determined by measuring grip force (kilograms) using hand grip dynamometer for participants ≥6 years of age. Baseline and post-baseline SDS values transformed to age and sex specific z-score. Change in hand grip calculated as SDS where SDS = hand grip minus mean (age- and sex-matched reference) divided by SD (age- and sex-matched reference). Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants ≥6 years of age with evaluable data at observation for Somatropin and Control Arm, respectively. SDS reference values used were for the right hand but the hand grip strength measured for this study was for the dominant hand (may not have been the right hand).|||z-score||Standard Error|Least Squares Mean
1286372|NCT00174460|Secondary|Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)|Bone stability expressed as polar SSI in cubic millimeters (mm3). SSI (proximal radius) SDS (number of standard deviations a participant's SSI differs from the average SSI of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
1286373|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)|Marrow Area measured as millimeters squared (mm2). MA (proximal radius) SDS (number of standard deviations a participant's MA differs from the average MA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Marrow Area was not analyzed as planned.||||||
1286374|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)|Cortical Thickness measured as millimeters (mm). CT (proximal radius) SDS (number of standard deviations a participant's CT differs from the average CT of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Cortical thickness was not analyzed as planned.||||||
1286375|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)|Bone structure Muscle CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
1286376|NCT00174460|Secondary|Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)|Bone structure Total CSA measured as millimeters squared (mm2). Total CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
1286393|NCT00174447|Primary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]|Intention to treat (ITT), all patients who received at least one dose of study medication and who have at least one post baseline efficacy evaluation. Imputation at Last Observation Carried Forward (LOCF).|||participants|||Number
1286377|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)|Bone structure Cortical CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
1286378|NCT00174460|Primary|Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year|Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline to 1 year (Month 12)|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters per year||Standard Error|Least Squares Mean
1286379|NCT00174460|Secondary|Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years|Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
1286380|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac|Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.|||millimeters||Standard Error|Least Squares Mean
1286381|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular|Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.|||millimeters||Standard Error|Least Squares Mean
1286382|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps|Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.|||millimeters||Standard Error|Least Squares Mean
1286383|NCT00174460|Secondary|Change From Baseline in Height SDS After 2 Years|Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline, Month 24|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters||Standard Error|Least Squares Mean
1286384|NCT00174460|Secondary|Change From Baseline in Height After 1 Year and After 2 Years||Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters||Standard Error|Least Squares Mean
1286385|NCT00174460|Secondary|Change From Baseline in Growth Velocity SDS After 2 Years|Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline, Month 24|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters per year||Standard Error|Least Squares Mean
1286386|NCT00174460|Secondary|Change From Baseline in Growth Velocity After 1 Year and After 2 Years|Growth velocity measured as centimeters per year.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters per year||Standard Error|Least Squares Mean
1286387|NCT00174460|Primary|Change in Height Standard Deviation Score (SDS) After 1 Year|Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline to 1 year (Month 12)|Full Analysis Set (FAS; all randomized subjects who had at least 1 post-baseline efficacy measurement); Control group received Somatropin from Month 12 onwards.|||centimeters||Standard Error|Least Squares Mean
1286388|NCT00174447|Primary|Change From Baseline in CGI-S at End of Study (up to 5 Years)|CGI-S Scale: standardized assessment tool to rate severity of subject’s illness; assesses investigator’s impression of subject’s current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.|Baseline, up to 5 years (End of Study [LOCF])|ITT. LOCF.|||score on a scale||Standard Deviation|Mean
1286389|NCT00174447|Primary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S Scale: standardized assessment tool to rate severity of subject’s illness; assessed investigator’s impression of subject’s current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).|Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]|ITT. LOCF.|||participants|||Number
1286390|NCT00174447|Secondary|Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)|DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Baseline, up to 5 years (End of Study)|ITT. n= number of participants with analyzable data.|||score on a scale||Standard Deviation|Mean
1286631|NCT00168844|Secondary|Change From Baseline in Platelets|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1286394|NCT00174382|Secondary|Clinical Global Impressions Improvement (CGI-I) Dichotomized Response|Scale measures subject’s (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more|Baseline, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy. LOCF = Last Observation Carried Forward. Week 24 n=116; Week 24 LOCF n=136|||Particpants|||Number
1286395|NCT00174382|Secondary|Clinical Global Impressions Improvement (CGI-I)|Scale measures subject’s clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline|Week (wk) 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with value (Week 24 n=116; Week 24 LOCF n=136)|||Participants|||Number
1286396|NCT00174382|Secondary|Clinical Global Impressions Severity (CGI-S)|Scale measures subject’s clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).|Baseline|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with a value|||Participants|||Number
1286397|NCT00174382|Secondary|Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)|Scale measures subject’s clinical condition at baseline for severity (CGI-S) & for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline|Baseline, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. Subjects with Baseline = 136; week 24 n = 116; week 24 LOCF n = 136|||Score on a scale||Standard Deviation|Mean
1286398|NCT00174382|Secondary|Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)|The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60|Baseline, week 12, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF n=137; weeks 12, 24 n = 124, 114|||Score on a scale||Standard Deviation|Mean
1286399|NCT00174382|Secondary|Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)|NPI-Q measures severity of behavioural manifestations of dementia & the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores & ranges from 0 to 36|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=137; weeks 12, 24 n = 124, 114|||Score on scale||Standard Deviation|Mean
1286400|NCT00174382|Secondary|Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)|The number of words a particpant can generate in 1 minute.|Baseline, 12 weeks, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=136; weeks 12, 24 n = 123, 113|||score on scale||Standard Deviation|Mean
1286401|NCT00174382|Secondary|CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)|CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF N=131; weeks 12, 24 n = 117, 106|||Score on a scale||Standard Deviation|Mean
1286402|NCT00174382|Secondary|Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)|The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF N=131; weeks 12, 24 n = 117, 106|||Score on scale||Standard Deviation|Mean
1286403|NCT00174382|Secondary|Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)|The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; weeks 12, 24 n = 123, 111|||Score on a scale||Standard Deviation|Mean
1286404|NCT00174382|Secondary|Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)|DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.|Baseline, week 12, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n = 124, 114|||score on a scale||Standard Deviation|Mean
1286405|NCT00174382|Secondary|Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.|IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance & correspondence, medications, leisure & housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124,114|||score on a scale||Standard Deviation|Mean
1286406|NCT00174382|Secondary|Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.|The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.|Baseline, week 12, week 24|Full Analysis Set (FAS): all subjects who received at least one dose of donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124, 114.|||score on a scale||Standard Deviation|Mean
1286407|NCT00174382|Primary|Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set|Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.|Baseline, week 12, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; Weeks 12, 24 n=124, 114|||Score on a scale||Standard Deviation|Mean
1286408|NCT00174291|Secondary|Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mg||Full Range|Median
1286409|NCT00174291|Secondary|Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9|Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender- appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||SDS||Full Range|Median
1286410|NCT00174291|Secondary|Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9|Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||grams||Full Range|Median
1286411|NCT00174291|Secondary|Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9|Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9|Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.||||||
1286412|NCT00174291|Secondary|Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.||||||
1286413|NCT00174291|Secondary|Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||milligram per deciliter (mg/dL)||Full Range|Median
1286414|NCT00174291|Primary|Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height|Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
1286415|NCT00174291|Primary|Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3|Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
1286427|NCT00174252|Other Pre-specified|BA/CA at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable BA/CA data at 12 and 24 months.|||ratio||Standard Deviation|Mean
1286428|NCT00174252|Other Pre-specified|Change in BA From Baseline at 12 and 24 Months|Change in BA was calculated as: (12 or 24 months minus Screening)|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BA data at 12 and 24 months.|||year||Standard Deviation|Mean
1286416|NCT00174291|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Final Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
1286417|NCT00174291|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Year 3|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
1286418|NCT00174291|Primary|Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height|Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|Data was not analyzed because of change in planned analysis after early termination of the study.||||||
1286419|NCT00174291|Primary|Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3|Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
1286420|NCT00174265|Secondary|Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score|The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.|Baseline of A7501013 to Day 365|ITT population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the MMRM model.|||Units on a Scale||Standard Error|Least Squares Mean
1286421|NCT00174265|Primary|Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score|The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.|Baseline of A7501013 to Day 365|Intent-to-treat (ITT) population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the Mixed Model for Repeated Measurements (MMRM) model.|||Units on a Scale||Standard Error|Least Squares Mean
1286422|NCT00174252|Secondary|IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months||12 and 24 months|SAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.|||ratio||Standard Deviation|Mean
1286423|NCT00174252|Secondary|IGF-1/Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months||12 and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.|||ratio||Standard Deviation|Mean
1286424|NCT00174252|Secondary|Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|IGF-1 SD was calculated at each study time point using these gender specific IGF-1 reference means and SDs for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 – reference mean) / reference SD|6, 9, 12, 15, 18, 21, and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.|||SD||Standard Deviation|Mean
1286425|NCT00174252|Secondary|Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|IGF-1 SD was calculated at each study time point using gender specific IGF-1 reference mean and SD for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 minus reference mean) divided by reference SD|6, 9, 12, 15, 18, 21, and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.|||SD||Standard Deviation|Mean
1286426|NCT00174252|Other Pre-specified|BA/CA at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable BA/CA data at 12 and 24 months.|||ratio||Standard Deviation|Mean
1286632|NCT00168844|Secondary|Change From Baseline in White Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/Litre (L)||Standard Deviation|Mean
1286429|NCT00174252|Secondary|ANCOVA for Height SD BA at 24 Months in Children With IGF-1 <= 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|Height SD (BA) at 24 months|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 24 months.|||SD for BA||Standard Error|Mean
1286430|NCT00174252|Secondary|ANCOVA for Height SD BA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|"Change in Height SD (BA) was calculated as:~Height SD (BA) at 12 months minus Height SD (BA) at Baseline"|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 12 months.|||SD for BA||Standard Error|Mean
1286431|NCT00174252|Secondary|ANCOVA for Height SD CA at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|Height SD (CA) at 24 months.|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 24 months.|||SD for CA||Standard Error|Mean
1286432|NCT00174252|Secondary|Analysis of Covariance (ANCOVA) for Height SD CA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|"Change in Height SD (CA) was calculated as:~Height SD (CA) at 12 months minus Height SD (CA) at Baseline"|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 12 months.|||SD for CA||Standard Error|Mean
1286433|NCT00174252|Other Pre-specified|Summary of Body Mass Index (BMI) at 12 and 24 Months|BMI was calculated at 12 months and 24 months as: (Weight at 12 or 24 months divided by Height at 12 or 24 months) squared|12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BMI data at 12 and 24 months.|||kg/meters squared (m2)||Standard Deviation|Mean
1286434|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 12 months. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 24 months.|||SD for BA||Standard Deviation|Mean
1286435|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for BA at 24 months|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 24 months.|||SD for BA||Standard Deviation|Mean
1286436|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 12 months.|||SD for CA||Standard Deviation|Mean
1286437|NCT00174252|Secondary|Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD CA data at 12 and 24 months.|||SD for CA||Standard Deviation|Mean
1286438|NCT00174252|Secondary|Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 12 months. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 24 months.|||SD for CA||Standard Deviation|Mean
1286439|NCT00174252|Other Pre-specified|Growth Rate at 12 and 24 Months|"Growth Rate was calculated at 12 months as:~(Height at 12 months minus Height at Day 0) divided by {(Date of 12 months minus Date of Day 0) divided by 365.25}~Growth Rate was calculated at 24 months as:~(Height at 24 months minus Height at 12 months) divided by {(Date of 24 months minus Date of 12 months) divided by 365.25}"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable growth rate data at 12 and 24 months.|||cm/year||Standard Deviation|Mean
1286440|NCT00174252|Secondary|Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 or 24 months” minus height in SD at “Baseline."|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 or 12 months with evaluable height SD BA data at 12 and 12 months.|||SD for BA||Standard Deviation|Mean
1286441|NCT00174252|Secondary|Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “24 months” minus height in SD at “Baseline."|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 24 months.|||Height in SD||Standard Deviation|Mean
1286633|NCT00168844|Secondary|Change From Baseline in Red Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^12/Litre (L)||Standard Deviation|Mean
1286634|NCT00168844|Secondary|Change From Baseline in Haemoglobin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||grams per litre (g/L)||Standard Deviation|Mean
1286442|NCT00174252|Secondary|Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 months” minus height in SD at Baseline."|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 12 months.|||SD for BA||Standard Deviation|Mean
1286443|NCT00174252|Secondary|Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 or 24 months” minus height in SD at “Baseline."|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable Height SD CA data at 12 and 24 months.|||SD for BA||Standard Deviation|Mean
1286444|NCT00174252|Secondary|Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “24 months” minus height in SD at Baseline."|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 24 months.|||SD for CA||Standard Deviation|Mean
1286445|NCT00174252|Secondary|Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at 12 months” minus height in SD at Baseline."|Baseline, 12 months|The full analysis set (FAS) included all patients who received at least one dose of assigned treatment and had at least one subsequent rating of IGF-1. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 12 months.|||SD for CA||Standard Deviation|Mean
1286446|NCT00174252|Primary|Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months|Percentage of children with serum IGF-1 > 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined.|9 and 12 months|The safety analysis set (SAS) was defined as all patients who received at least one dose of GH treatment. Number of Participants Analyzed = Number of children treated.|||percentage of participants|||Number
1286447|NCT00174252|Other Pre-specified|Change in Height From Baseline|The standing height measurements were performed at the same time of the day by using a wallmounted device (e.g. Harpenden Stadiometer) at each study visit. The pre-specified clinical outcomes were analyzed at 12 and 24 months.|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with evaluable height data at 12 and 24 months.|||centimeters (cm)||Standard Deviation|Mean
1286448|NCT00174187|Other Pre-specified|Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3||Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)|FAS After year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.|||milligram per deciliter (mg/dL)||Full Range|Median
1286449|NCT00174187|Other Pre-specified|Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3||Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||nanogram per milliliter (ng/mL)||Full Range|Median
1286450|NCT00174187|Other Pre-specified|Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])|GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
1286451|NCT00174187|Other Pre-specified|Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])|GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
1286452|NCT00174187|Other Pre-specified|Growth Velocity (GV)|Growth velocity measures the annual rate of increase in height.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||cm/year||Inter-Quartile Range|Median
1286474|NCT00174187|Primary|Puberty Stage at Final Height|Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.|When final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment.|||participants|||Number
1286453|NCT00174187|Secondary|Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])|BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
1286454|NCT00174187|Secondary|Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])|BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
1286455|NCT00174187|Secondary|Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3|BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC [TB] at Year 3 minus BMC [TB] at baseline) divided by BMC [TB] at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Inter-Quartile Range|Median
1286456|NCT00174187|Secondary|Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3|BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC [TB] at current year minus BMC [TB] at previous year) divided by BMC [TB] at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percent change||Inter-Quartile Range|Median
1286457|NCT00174187|Secondary|Bone Mineral Content of Total Body (BMC [TB])|DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||gram||Inter-Quartile Range|Median
1286458|NCT00174187|Secondary|Bone Mineral Density of Lumbar Spine (BMD [LS])|BMD (LS) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||g/cm^2||Inter-Quartile Range|Median
1286459|NCT00174187|Secondary|Bone Mineral Density of Total Body (BMD [TB])|BMD (TB) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||gram per square centimeter (g/cm^2)||Inter-Quartile Range|Median
1286460|NCT00174187|Secondary|Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])|BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
1286461|NCT00174187|Secondary|Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])|BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
1286462|NCT00174187|Secondary|Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])|BMAD (LS) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||gram per cubic centimeter (g/cm^3)||Inter-Quartile Range|Median
1286463|NCT00174187|Secondary|Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)|Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
1286464|NCT00174187|Secondary|Fat Mass as Percentage of Total Weight|Fat mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percentage of total weight||Inter-Quartile Range|Median
1286465|NCT00174187|Secondary|Percent Change From Baseline in Fat Mass at Year 3|Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Inter-Quartile Range|Median
1286466|NCT00174187|Secondary|Annual Percent Change in Fat Mass at Year 1, 2 and 3|Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percent change||Inter-Quartile Range|Median
1286467|NCT00174187|Secondary|Fat Mass|Fat mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||kg||Inter-Quartile Range|Median
1286468|NCT00174187|Secondary|Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)|Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
1286469|NCT00174187|Secondary|Lean Body Mass as Percentage of Total Weight|Lean body mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percentage of total weight||Inter-Quartile Range|Median
1286470|NCT00174187|Secondary|Percent Change From Baseline in Lean Body Mass at Year 3|Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Inter-Quartile Range|Median
1286471|NCT00174187|Secondary|Annual Percent Change in Lean Body Mass at Year 1, 2 and 3|Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percent change||Inter-Quartile Range|Median
1286472|NCT00174187|Secondary|Lean Body Mass|Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||kilogram (kg)||Inter-Quartile Range|Median
1286473|NCT00174187|Secondary|Bone Age|Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|||years||Inter-Quartile Range|Median
1286570|NCT00169442|Secondary|Anti-D and Anti-T Antibody Concentrations.|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1286475|NCT00174187|Primary|Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height|Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, when final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.|||SDS||Full Range|Median
1286476|NCT00174187|Primary|Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, when final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points.|||SDS||Full Range|Median
1286477|NCT00174187|Primary|Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year.|||Standard Deviation Score (SDS)||Inter-Quartile Range|Median
1286478|NCT00172185|Secondary|Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use|Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)|6 months|Response Status is Yes or No|||participants|||Number
1286479|NCT00172185|Primary|Number of Subjects Achieving a 20% Reduction at Week 28|"For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use.~For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use."|28 weeks|Number of participants for analysis was determined based on completing all of the prerequisite visits in Study 005. Subjects who dropped out of the study were considered failures.|||Participants|||Number
1286480|NCT00172042|Primary|Percentage of Participants With Progression-Free Survival Events|Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Up to 24 months|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants|||Number
1286481|NCT00172042|Primary|Kaplan-Meier Estimates for Progression-free Survival|Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1286482|NCT00172042|Secondary|Kaplan-Meier Estimates for Overall Survival||Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1286483|NCT00172042|Secondary|Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)|Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event|Months 6,12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants. Any participant in whom no SRE had been observed during the study was to be censored at the date of the last visit or the date of death whichever was the earlier.|||Percentage of participants||95% Confidence Interval|Number
1286484|NCT00172042|Secondary|Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry|Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.|Months 12 and 24|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants|||Number
1286485|NCT00172042|Secondary|Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases|Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).|Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants. Any participant without documented bone metastases at the date of analysis was to be censored at the date of the last bone scan.|||Percentage of participants||95% Confidence Interval|Number
1286571|NCT00169442|Secondary|Anti- PRP Antibody Concentrations.|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1286486|NCT00172042|Secondary|Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months|Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).|Months 6, 12, 18 and 24|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants|||Number
1286487|NCT00172042|Primary|Progression-Free Survival|Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Up to 24 months|Intent-to-Treat Population consisting of all randomized participants.|||Months||95% Confidence Interval|Median
1286488|NCT00171925|Secondary|The Number of Participants With the Development of Skeletal Complications|"Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline~Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography~Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression~Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression~Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl"|48 months|Intent to treat population|||Participants|||Number
1286489|NCT00171925|Secondary|Number of Patients With Progression by Individual Criteria|Number of patients with progression by individual criteria consisting of Progression of disease overall, Skeletal-related events (including pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or Hypercalcemia), Progression to stage II or III according to Salmon & Durie classification, and unequivocal progression of osteolytic lesion. Patients are counted separately for every type of progression, but only once for Overall Progression.|48 months|Intent to Treat Population|||Participants|||Number
1286490|NCT00171925|Primary|Days of Progression Free Survival|"Progression-free survival was defined as time from date of randomization to death from any cause or one of the following events:~progression to stage II or III according to Salmon & Durie classification~skeletal related events (pathologic fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or hypercalcemia)~unequivocal progression of osteolytic lesions (at least a 20% increase in the largest diameter of one existing osteolytic lesion which is measured in at least one dimension as 20 mm with conventional techniques), determined radiologically."|48 months|Intent to Treat Population|||Days||Standard Error|Mean
1286491|NCT00171873|Secondary|Survival||at least on a monthly basis||2014-12-31|12/2014||||
1286492|NCT00171873|Secondary|Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study||at three-month intervals||2014-12-31|12/2014||||
1286493|NCT00171873|Secondary|Symptom Control at 3 Month Intervals||at 3 month intervals up to 18 moths||2014-12-31|12/2014||||
1286494|NCT00171873|Secondary|Biochemical Response at 3 Month Intervals||at 3 month intervals up to 18 moths||2014-12-31|12/2014||||
1286495|NCT00171873|Secondary|Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals||at 3 month intervals||2014-12-31|12/2014||||
1286496|NCT00171873|Primary|Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)|Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.|Up to 7 years|Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis.|||Months||95% Confidence Interval|Median
1286497|NCT00171834|Secondary|Duration of Overall Response -Phase I and Phase II|Duration of overall response (CR or PR) measured by RECIST was measured from the first documented CR or PR to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.|Duration of response according to RECIST from start of study until study discontinuation. Duration of response was assessed every second cycle ( i.e. approximately every 6 weeks) until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
1286498|NCT00171834|Secondary|Time to Overall Response -Phase I and Phase II|Time to overall response (CR or PR) measured by RECIST was the time between study start until date of first documented response (CR or PR).|From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
1286499|NCT00171834|Secondary|Duration of Stable Disease-Phase I and Phase II|Duration of stable disease (CR, PR, or SD) by RECIST was defined as the time from start of study drug to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.|Imaging was assessed every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from treatment . Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
1286572|NCT00169442|Secondary|Anti- PRP Antibody Concentrations|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1286500|NCT00171834|Primary|Phase II: Number of Participants With Best Overall Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Overall response is the number of participants who had a complete response (CR) or a partial response (PR) based on local investigator’s assessment of RECIST criteria. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.|At baseline, then every second cycle (approximately every 6 weeks), until disease progression or discontinuation. Average 18 weeks.|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Participants|||Number
1286501|NCT00171834|Primary|Phase I: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of patupilone administered every three weeks (q3w) where not more than one out of six patients experienced a DLT using a standard 3+3 design. Dose escalation started at 6.5 mg/m^2 until MTD in steps of 0.5 mg/m^2 until 12 mg/m^2, then in steps of 1 mg/m^2 till 13.0 mg/m^2. DLTs were assessed during cycle 1. During this time frame, no more than one DLT occurred in any of the explored dose levels up to 13 mg/m^2, thus, the MTD as defined by the protocol was not reached in this study.|Cycle 1 (21 days)|Maximum tolerated dose (MTD) determining population.included all patients who completed the first treatment cycle (Cycle 1) according to protocol or discontinued due to a DLT. The first cycle data from this patient population were used to determine the MTD in the Phase I part of the study.|||Dose Limiting Toxicity (DLT)|||Number
1286502|NCT00171834|Secondary|Time to Progression (TTP)-Phase I and Phase II|Time to progression was measured from the start of study drug to the date of first documented disease progression by RECIST, discontinuation due to disease progression, or death from underlying cancer, whichever event occurred first. If a patient had not progressed by RECIST, discontinued due to disease progression, or died from underlying cancer, TTP was censored at the time of last adequate tumor assessment. However, if a patient took any new cancer therapy prior to PD or death, then TTP was censored at the date of last adequate tumor assessment prior to the start date of new cancer therapy.|From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
1286503|NCT00171834|Secondary|Overall Survival Time-Phase I and Phase II|Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Data was collected post treatment every 3 months until approximately 70% of patients have reached the survival endpoint (Phase I + Phase II).|From start of study drug to date of death due to any cause. Follow-up after treatment discontinuation approximately every 3 months until approximately 70% of participants have reached the survival endpoint. Average 9.75 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
1286504|NCT00171834|Secondary|Number of Participants With Best Overall Response-Phase I|This was defined as the number of participants whose best overall response was CR or PR by RECIST. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.|Best achieved overall response according to RECIST from start of study until study discontinuation. Imaging was assessed every second cycle (ie. approximately every 6 weeks) until disease progression or discontinuation. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Participants|||Number
1286505|NCT00171704|Secondary|Time to Overall Survival Events|Overall survival was measured from date of randomization to date of death.|60 Months|All randomized patients constituted the ITT Population, unless withdrawal of consent occurred after randomization but before the start of study treatment assigned.|||days||Inter-Quartile Range|Median
1286506|NCT00171704|Secondary|Time to Disease Recurrence or Death|Disease-free survival was defined as the interval between randomization and earliest confirmed event of loco-regional recurrence, distant metastases, invasive contralateral breast cancer, or death from any cause.|60 months|Analysis of disease-free survival was based on the ITT principle, with all enrolled (and randomized) patients included. The Kaplan-Meier product-limit approach was used.|||Days||Inter-Quartile Range|Median
1286507|NCT00171704|Secondary|Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol|Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. Numbers are not additive, as patients could be included in multiple rows.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients with pre-defined clinically relevant changes in serum lipids over the course of 5 years in each treatment arm is presented.|||Participants|||Number
1286597|NCT00168844|Secondary|COPD Symptoms Scores|"COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - COPD symptoms (FAS-SYM)|||Points on a scale||Standard Error|Mean
1286508|NCT00171704|Secondary|Percentage Change From Baseline in Serum Lipids at 5 Years|Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of serum lipids was on the treatment group median percent change from baseline (and range) at 5 years.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis.|||Percent Change||Full Range|Median
1286509|NCT00171704|Secondary|Median Percent Change From Baseline of Serum Markers of Bone Turnover|Bone turnover markers (fasting serum procollagen-I extension peptide [P1NP], C-telopeptide [CTX], skeletal bone-specific alkaline phosphatase [BSAP, N-telopeptide [NTX]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of bone markers was based on analysis of variance of the regression slopes calculated for each individual patient and each bone marker over time. In the following summary, only the median treatment group percent change from baseline (and range) at 5 years is presented for each bone marker.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis. The analysis of bone markers over time consisted of patients with measurements of specific markers at each time point.|||Percent Change||Full Range|Median
1286510|NCT00171704|Secondary|Percent Change From Baseline of Bone Mineral Density (BMD) of Total Hip|Total hip BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. All DXA scans were evaluated by a central reader.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The analysis of BMD at 5 years included all patients enrolled with centrally assessed measurements of total hip BMD.|||Percent Change||Full Range|Median
1286511|NCT00171704|Secondary|Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine|Lumbar spine (L2-L4)BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The analysis at 5 years included all patients enrolled and who had centrally assessed measurements of lumbar spine and/or total hip BMD.|||Percent change||Full Range|Median
1286512|NCT00171704|Primary|Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)|Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.|Baseline, 24 months|The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients in each treatment arm who had completed 2 years of the study and had centrally assessed measurements of lumbar spine or total hip BMD.|||Percent Change||Full Range|Median
1286513|NCT00171340|Secondary|Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline|At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.|Baseline,3 years|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.|||Percentage of Participants|||Number
1286514|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.|||Percentage change in BMD||Standard Deviation|Mean
1286515|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.|||Percentage change in BMD||Standard Deviation|Mean
1286516|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.|||Percentage change in BMD||Standard Deviation|Mean
1286517|NCT00171340|Primary|Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).|Baseline, 12 months|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.|||Percentage change in BMD||Standard Deviation|Mean
1286518|NCT00171314|Secondary|Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3|Radiological Fracture at 36 months which was not present at baseline = (new fracture/number participant analyzed)*100. Evaluation of radiological fractures were based on central lab X-ray data. A subject with multiple fractures at the same time or multiple fractures with the same grade is counted only once for that treatment.|Year 3|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. Participants with observations at Year 3 were included in this analysis.|||Percentage of Participants|||Number
1286519|NCT00171314|Secondary|Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From baseline to Year 1, Year 2, Year 3, Year 4, Year 5|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. During different time points, participants with observations at that time point were included in the analysis.|||Percent Change||Standard Deviation|Mean
1286520|NCT00171314|Secondary|Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization.|||Percent Change||Standard Deviation|Mean
1286521|NCT00171314|Secondary|Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline to Year 2, Year 3, Year 4, Year 5|"Analysis of safety:safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. n in each category indicates participants with data at baseline and each corresponding timepoint."|||Percent Change||Standard Deviation|Mean
1286522|NCT00171314|Primary|Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline - 12 months|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. Participants with observations at baseline and 12 months were included in this analysis.|||Percent Change||Standard Deviation|Mean
1286523|NCT00171301|Secondary|Absolute Change in Serum Ferritin Level for All Participants Measured From Core Study Baseline (BL) to End of Extension Study, by Baseline Liver Iron Content (LIC)|Serum Levels were assessed at core study baseline (BL) and then 1 year and 2 years in core study, baseline of extension study and time of discontinuation from the extension visit (end of study). Serum Ferritin is reported in micrograms per Liter. Absolute change in Serum Ferritin from core study baseline to the end of the extension study is presented for participants with the following two core study baseline LIC levels: 1-<7 mg Fe/g dw and ≥7 mg Fe/g dw.|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom Serum Ferritin data was available at Core Study baseline and at the End of Extension Study. “n” is the number of participants analyzed in each category.|||µg/L||Standard Deviation|Mean
1286524|NCT00171301|Secondary|Absolute Change in Serum Ferritin Level Measured From Core Study Baseline (BL) to End of Extension Study|Serum Levels were assessed at core study baseline (BL), 1 year, 2 years in core study, baseline of extension study and time of discontinuation from the extension visit (end of study) in monthly intervals. Serum Ferritin is reported in micrograms per Liter (µg/L).|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom Serum Ferritin data was available at Core Study baseline and at the End of Extension Study.|||µg/L||Standard Deviation|Mean
1286525|NCT00171301|Primary|Absolute Change in Liver Iron Concentration (LIC)Measured by Liver MRI or Liver Biopsy From Core Study Baseline (BL) to End of Extension Study, by LIC Category|"Liver MRI or Liver Biopsy was performed at the core study baseline (BL) and then 1 year and 2 years in the core study, baseline of the extension study and time of discontinuation from the extension visit (end of study). Liver iron content (LIC) is reported in milligram Iron per gram dry weight (mg Fe/g dw).~Absolute change in LIC from core study baseline to the end of the extension study is presented for participants with the following two core study baseline LIC levels: 1-<7 mg Fe/g dw and ≥7 mg Fe/g dw."|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom LIC data was available at Core Study baseline and at the End of Extension Study. “n” is the number of participants analyzed in each category.|||mg Fe/g dw||Standard Deviation|Mean
1286526|NCT00171301|Primary|Percentage of Participants With Treatment Success From Core Baseline (BL) to Extension End of Study, by Baseline LIC Level and Age|Success was defined as the percentage of participants with decreased liver iron content (LIC) at the end of extension study compared to core baseline (BL) LIC. Success Criteria: For participants with Baseline LIC from 1 - <7 mg Fe/g dw, success was achieved if LIC level maintained at 1 - <7 mg Fe/g dw. For participants with Baseline LIC ≥7 - <10 mg Fe/g dw, success was achieved if LIC dropped to between 1 and < 7 mg Fe/g dw. For participants with Baseline LIC ≥10 mg Fe/g dw, success was achieved if LIC dropped by at least 3 mg Fe/g dw. LIC was measured by biopsy or magnetic resonance imaging.|From Core Study Baseline, to Extension End of Study, Up to 3 Years|The primary analysis will be on the intent-to-treat (ITT) population. ITT population includes all participants who performed the core end of study (EOS) visit evaluation and assessments and were included in the extension study. “n” is the number of participants analyzed in each category.|||percentage of participants||95% Confidence Interval|Mean
1286527|NCT00171210|Secondary|Change of Total Body Iron Excretion Rate (TBIE) From Start of ICL670 Treatment to the End of Study|Median change in TBIE (mg/kg/day) from start of treatment with Deferasirox (ICL670) to end of study.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||mg/kg/day||Full Range|Median
1286546|NCT00171054|Secondary|Changes in Mean Left Carotid Distensibility at Week 12|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
1286528|NCT00171210|Secondary|Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study as Measured by SQUID|Relative change in liver iron content (LIC) measured by Superconducting Quantum Interfering Device (SQUID), calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.|||percent of start value||Full Range|Median
1286529|NCT00171210|Secondary|Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID|Measurement of the median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through Superconducting Quantum Interfering Device (SQUID). Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.|||mg Fe/g dw||Full Range|Median
1286530|NCT00171210|Secondary|Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy|Relative change in liver iron content (LIC) as measured by biopsy and calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.|||percent of start value||Full Range|Median
1286531|NCT00171210|Secondary|Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy|Measurement of median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through biopsy. Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.|||mg Fe/g dw||Full Range|Median
1286532|NCT00171210|Secondary|Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change of potential surrogate marker: Transferrin Saturation (Percent) from start of treatment with Deferasirox (ICL670) to end of study.~(Transferrin Saturation at the End of Study-Tranferrin Saturation at Start of ICL670)/Transferrin Saturation at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||Percent change||Standard Deviation|Mean
1286533|NCT00171210|Secondary|Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change of potential surrogate markers: Serum Iron (µmol/L) from start of treatment with Deferasirox (ICL670) to end of study.~(Serum Iron at the End of Study-Serum Iron at Start of ICL670)/Serum Iron at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||Percent change||Standard Deviation|Mean
1286534|NCT00171210|Secondary|Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change in percent of potential surrogate marker: Serum Transferrin (g/L) from start of treatment with Deferasirox (ICL670) to end of study.~(Serum Transferrin at the End of Study-Serum Transferrin at Start of ICL670)/Serum Transferrin at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||Percent change||Standard Deviation|Mean
1286535|NCT00171210|Secondary|Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study|Mean Absolute Change in serum ferritin (ug/L) from start of treatment with Deferasirox (ICL670) to end of study taking into account the therapeutic goal which will either be to maintain iron balance or to induce negative iron balance. End of study taken as the mean of, at most, the last three available results after start of treatment with ICL670.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||μg/L||Standard Deviation|Mean
1286556|NCT00170846|Post-Hoc|Change in mGFR by Baseline Calculated Creatinine Clearance (Cockcroft-Gault Formula)|"Cockcroft-Gault formula (CrCl):~Creatinine Clearance [mL/min] = CrCl (males) = (140 – A) * W / (72 * C) (males), CrCl (females) = CrCl (males) * 0.85,~Where:~A is age [years]~W is body weight [kg]~C is the serum concentration of creatinine [mg/dL]"|Baseline and 24 months|Per Protocol Population. The per-protocol (PP) population consisted of the ITT patients excluding those patients with major protocol deviations and those patients who were not able to initiate their randomized regimens as scheduled.|||mL/min||Standard Deviation|Mean
1286536|NCT00171210|Secondary|Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID|Mean absolute change in LIC from start of Deferasirox (ICL670) treatment to the end of the study assessed by Superconducting Quantum Interfering Device (SQUID) measurement used as a non-invasive alternative to Biopsy for pediatric participants. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.|||mg Fe/g dw||Standard Deviation|Mean
1286537|NCT00171210|Secondary|Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy|Mean absolute change of LIC from start of Deferasirox (ICL670) treatment to the end of study assessed by liver biopsy. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.|||mg Fe/g dw||Standard Deviation|Mean
1286538|NCT00171210|Primary|Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event|Adverse events results are based on preferred terms with at least 7% of participants in any group.|up to 5 years|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||Participants|||Number
1286539|NCT00171054|Secondary|Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38|Central Blood Pressure was measured via applanation tonometry recordings of the common carotid artery and from brachial oscillometric recordings. The Simultaneously obtained carotid artery pressure and standard brachial artery blood pressure are computed to obtain the central systolic pressure.|Baseline, Week 12 and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||mm Hg||Standard Error|Least Squares Mean
1286540|NCT00171054|Secondary|Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38||Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
1286541|NCT00171054|Secondary|Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38|The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||EP||Standard Error|Least Squares Mean
1286542|NCT00171054|Secondary|Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12|The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||EP||Standard Error|Least Squares Mean
1286543|NCT00171054|Secondary|Changes in Mean Right Carotid Distensibility at Week 38|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
1286544|NCT00171054|Secondary|Changes in Mean Right Carotid Distensibility at Week 12|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
1286545|NCT00171054|Secondary|Changes in Mean Left Carotid Distensibility at Week 38|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
1286598|NCT00168844|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Scores|"Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|||Points on a scale||Standard Error|Mean
1286547|NCT00171054|Secondary|Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)|Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
1286548|NCT00171054|Secondary|Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12|Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
1286549|NCT00171054|Secondary|Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)|Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).|Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||Perfusion units||Standard Error|Least Squares Mean
1286550|NCT00171054|Secondary|Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12|Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||Perfusion units||Standard Error|Least Squares Mean
1286551|NCT00171054|Primary|Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)|PWV was determined from transcutaneous Doppler flow recordings and the foot-to-foot method triggered by the simultaneous ECG. Two simultaneous Doppler flow tracings were taken at the left common carotid and the right femoral artery in the groin with a linear array probe. The time delay (t) was measured between R wave of the ECG and the base of the flow waves recorded at these points, and averaged over 10 beats. The distance (D) traveled by the pulse wave was measured over body surface as the distance from the suprasternal notch to the carotid artery. PWV was calculated as PWV=D/t.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||m/s||Standard Error|Least Squares Mean
1286552|NCT00170950|Secondary|Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke|CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes.|For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])|Intent-to-treat population: All randomized patients by assigned treatment group|||Percentage of Patients with an Event|||Number
1286553|NCT00170950|Secondary|Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event|Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG).|For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]|Intent-to-treat population: All randomized patients by assigned treatment group|||Percentage of Patients with an Event|||Number
1286554|NCT00170950|Primary|Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event|CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes.|For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])|Intent-to-treat population: All randomized patients by assigned treatment group|||Percentage of Patients with an event|||Number
1286555|NCT00170846|Secondary|Number of Participants With Safety Parameters|The selected safety parameters (such as hypertension, hyperlipidemia, diabetes mellitus, anemia, malignancies ) were derived based on adverse events preferred terms defined in the analysis plan.|24 months|Safety Population. The Safety Population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Number
1286635|NCT00168844|Secondary|Change From Baseline in Haematocrit, Packed Cell Volume (PCV)|Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||Percentage of erythrocytes||Standard Deviation|Mean
1286557|NCT00170846|Primary|Renal Function Assessed by Measured GFR (mGFR)|The acceptable methods for GFR measurement were Chromium 51-Ethylenediaminetetra acetic acid (Cr-EDTA), Technetium 99-Diethylenetriaminepentacetic acid (Tc-DTPA), Iohexol clearance Inuline clearance and Iothalamate clearance. The method should have been consistent for a given patient at every time point.|24 months|The modified ITT population included all ITT patients who had mGFR or calculated GFR (cGFR) at Month 24 based on all values including those collected after discontinuation of study medication.|||mL/min/1.73m^2||Standard Deviation|Mean
1286558|NCT00170625|Secondary|Progression-free Survival|progression-free survival according to kaplan-meier-estimator|after every third cycle, for up to one year||||months||95% Confidence Interval|Median
1286559|NCT00170625|Primary|Toxicity|hematological adverse events and non-hematological adverse events grade 3/4|after each cycle for up to one year||||participants|||Number
1286560|NCT00170157|Secondary|Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response|Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over).|3 months|105 participants had follow-up PSA information; those without a follow-up PSA were excluded from this analysis.|||percentage of participants|||Number
1286561|NCT00170157|Primary|Number of Participants Progression-free at 18 Months|PSA progression is defined as a rise in PSA to >4.0 ng/mL demonstrated twice in measurements taken two weeks apart.|18 months from the start of AA therapy||||participants|||Number
1286562|NCT00169442|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 9.5)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1286563|NCT00169442|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-Day (Day 0-30) follow-up period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1286564|NCT00169442|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-Day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
1286565|NCT00169442|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-Day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
1286566|NCT00169442|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-Day (Days 0-3) post-PRP challenge|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
1286567|NCT00169442|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-Day (Days 0-3) post-PRP challenge|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
1286568|NCT00169442|Secondary|Anti-BPT Antibody Concentrations.|Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1286569|NCT00169442|Secondary|Anti-HBs Antibody Concentrations.|Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1286599|NCT00168844|Secondary|Mahler TDI Scores|"Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.~Worst score = -3, best score = +3"|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)|||Points on a scale||Standard Error|Mean
1286573|NCT00169442|Secondary|Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286574|NCT00169442|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286575|NCT00169442|Secondary|Seroprotection Rates for Anti-D Antibodies|The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Proportion||95% Confidence Interval|Number
1286576|NCT00169442|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286577|NCT00169442|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286578|NCT00169442|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286579|NCT00169442|Primary|Anti-BPT Antibody Concentrations|Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1286580|NCT00169442|Primary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1286581|NCT00169442|Primary|Anti-D and Anti-T Antibody Concentrations|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1286582|NCT00169442|Primary|Anti-PRP Antibody Concentrations.|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1286583|NCT00169442|Primary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 1, post-PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1286584|NCT00169442|Primary|Number of Subjects With Booster Response to BPT Antigen|"The booster response was defined as:~an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or~at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose."|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286585|NCT00169442|Primary|Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)|A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286600|NCT00168844|Secondary|Weekly Mean Number of Puffs of Rescue Medication Per Day|Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Puffs||Standard Error|Mean
1286586|NCT00169442|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286587|NCT00169442|Primary|Seroprotection Rates for Anti-D Antibodies|The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Proportion||95% Confidence Interval|Number
1286588|NCT00169442|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286589|NCT00169442|Primary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286590|NCT00169442|Primary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.|At Month 1, post-PRP challenge|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1286591|NCT00169104|Secondary|Safety of the Combination of Trastuzumab, G-CSF, and Vinorelbine in Subjects With Her-2 Overexpressing Metastatic Breast Cancer|"Adverse events were graded per RECIST v4.0. There were two severe adverse events: Grade 3 mental status changes in one subject on the G-CSF arm, and Grade 3 febrile neutropenia in one subject on the Placebo arm.~Refer to Adverse Events Table for specifics."|14 weeks|19 subjects (11 on the G-CSF arm and 8 on the placebo arm) received at least two weeks of treatment on study and were evaluable for toxicity.|||Participants|||Count of Participants
1286592|NCT00169104|Secondary|Clinical Response Rate of the Combination of Trastuzumab, G-CSF, and Vinorelbine in Subjects With Her-2 Overexpressing Metastatic Breast Cancer|"19 subjects (11 on the G-CSF arm and 8 on the placebo arm) completed 14 weeks of treatment and completed restaging at that time.~Responses were evaluated by RECIST criteria."|14 weeks|19 subjects completed 14 weeks of treatment and underwent restaging at that timepoint.|||Participants|||Count of Participants
1286593|NCT00169104|Secondary|Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Chemotherapy, Trastuzumab, and G-CSF Against a Her-2 Overexpressing Target in Vitro|"Buffy coat effector cells were isolated by centrifugation from heparinized blood, washed, and counted. SKBR3 target cells were labeled with 51-Cr at 100 uCi per 5 x 105 cells for 1 hour at 37 C, washed and effector cells and target cells were plated at a ratio of 70:1 in 96 well microtiter plates, with trastuzumab 2 ug/ml and with no antibody. After addition of the target cells, the plate was centrifuged gently at 1200 rpm to pellet cells, the plate was incubated for 4 hours at 37C, and 100 uL of supernatant was measured on a gamma counter set for 51Cr counting for 1 minute per tube. Specific lysis in % is defined as follows:~% specific lysis = (counts released into the supernatant under experimental conditions – spontaneous counts released into the supernatant) / (maximum counts released into the supernatant – spontaneous counts released into the supernatant)~Specific lysis at Week 14 was compared to specific lysis at baseline for 17 patients with week 14 samples available."|Baseline and 14 weeks|17 of 19 subjects had results from ADCC assays from baseline and at week 14. Because subjects on both arms of the trial received the identical treatment with 12 weeks of vinorelbine and G-CSF after the initial two week randomization, it is appropriate to pool the results of the ADCC assays at the 14 week timepoint from both arms.|||percentage of specific lysis||Standard Deviation|Median
1286594|NCT00169104|Primary|Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Trastuzumab With Either G-CSF or a Saline Placebo Against a Her-2 Overexpressing Target in Vitro|"Buffy coat effector cells were isolated by centrifugation from heparinized blood, and washed and counted. SKBR3 target cells were labeled with 51-Cr at 100 uCi per 5 x 105 cells for 1 hour at 37 C, washed and effector cells and target cells were plated at a ratio of 70:1 in 96 well microtiter plates, with trastuzumab 2 ug/ml and with no antibody. After addition of the target cells, the plate was centrifuged gently at 1200 rpm to pellet cells, the plate was incubated for 4 hours at 37C, and 100 uL of supernatant was measured on a gamma counter set for 51Cr counting for 1 minute per tube. Specific lysis in % is defined as follows:~% specific lysis = (counts released into the supernatant under experimental conditions – spontaneous counts released into the supernatant) / (maximum counts released into the supernatant – spontaneous counts released into the supernatant)~Specific lysis at Day 12 was compared to specific lysis at baseline between the G-CSF group and the placebo group."|Baseline and 12 days|19 subjects were evaluable for response and toxicity, but only 17 subjects had evaluable specific lysis laboratory outcomes at baseline and at Day 12.|||percentage of specific lysis||Standard Deviation|Mean
1286595|NCT00168844|Secondary|PGR Score|"Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Patient's Global Rating (FAS-PGR)|||Points on a scale||Standard Error|Mean
1286596|NCT00168844|Secondary|PGE Scores|"Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Physician's Global Evaluation (FAS-PGE)|||Points on a scale||Standard Error|Mean
1286603|NCT00168844|Secondary|Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286604|NCT00168844|Secondary|Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286605|NCT00168844|Secondary|Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks|Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286606|NCT00168844|Secondary|Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286607|NCT00168844|Secondary|Change From Baseline in Albumin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||g/L||Standard Deviation|Mean
1286608|NCT00168844|Secondary|Change From Baseline in Protein, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||grams per litre (g/L)||Standard Deviation|Mean
1286609|NCT00168844|Secondary|Change From Baseline in Uric Acid|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||umol/L||Standard Deviation|Mean
1286610|NCT00168844|Secondary|Change From Baseline in Bilirubin, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||umol/L||Standard Deviation|Mean
1286611|NCT00168844|Secondary|Change From Baseline in Creatinine|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||micromoles per litre (umol/L)||Standard Deviation|Mean
1286612|NCT00168844|Secondary|Change From Baseline in Blood Urea Nitrogen|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||milligrams per decilitre (mg/dL)||Standard Deviation|Mean
1286613|NCT00168844|Secondary|Change From Baseline in Urea|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
1286614|NCT00168844|Secondary|Change From Baseline in Glucose|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
1286615|NCT00168844|Secondary|Change From Baseline in Lactic Dehydrogenase (LDH)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
1286616|NCT00168844|Secondary|Change From Baseline in Alkaline Phosphatase|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
1286617|NCT00168844|Secondary|Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
1286618|NCT00168844|Secondary|Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||Units per litre (U/L)||Standard Deviation|Mean
1286619|NCT00168844|Secondary|Change From Baseline in Phosphate|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
1286620|NCT00168844|Secondary|Change From Baseline in Calcium|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||millimoles per litre (mmol/L)||Standard Deviation|Mean
1286621|NCT00168844|Secondary|Change From Baseline in Monocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1286622|NCT00168844|Secondary|Change From Baseline in Basophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1286623|NCT00168844|Secondary|Change From Baseline in Eosinophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1286624|NCT00168844|Secondary|Change From Baseline in Lymphocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1286625|NCT00168844|Secondary|Change From Baseline in Neutrophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
1286626|NCT00168844|Secondary|Change From Baseline in Monocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1286627|NCT00168844|Secondary|Change From Baseline in Lymphocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1286628|NCT00168844|Secondary|Change From Baseline in Basophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1286629|NCT00168844|Secondary|Change From Baseline in Eosinophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
1286636|NCT00168844|Secondary|Change From Baseline in VPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||pairs per 24 hours||Standard Deviation|Mean
1286637|NCT00168844|Secondary|Change From Baseline in VPB Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||events per 24 hours||Standard Deviation|Mean
1286638|NCT00168844|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||premature beats per 24 hours||Standard Deviation|Mean
1286639|NCT00168844|Secondary|Change From Baseline in SVPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||pairs per 24 hours||Standard Deviation|Mean
1286640|NCT00168844|Secondary|Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||events per 24 hours||Standard Deviation|Mean
1286641|NCT00168844|Secondary|Change From Baseline in Supraventricular Premature Beat (SVPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||premature beats per 24 hours||Standard Deviation|Mean
1286642|NCT00168844|Secondary|Change From Baseline in Heart Rate|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||bpm||Standard Deviation|Mean
1286643|NCT00168844|Secondary|Change From Baseline in QT Interval (Fridericia)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
1286644|NCT00168844|Secondary|Change From Baseline in QT Interval (Bazett)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
1286645|NCT00168844|Secondary|Change From Baseline in QT Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
1286646|NCT00168844|Secondary|Change From Baseline in QRS Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
1286647|NCT00168844|Secondary|Change From Baseline in PR Interval||Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||milliseconds (msec)||Standard Deviation|Mean
1286648|NCT00168844|Secondary|Change From Baseline in Heart Rate|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||beats per minute (bpm)||Standard Deviation|Mean
1286649|NCT00168844|Primary|COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)|"Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year.~For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined."|48 weeks|Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively.|||Number of exacerbations per patient year||Standard Deviation|Mean
1286650|NCT00168844|Primary|TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)|"Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9~For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined."|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)|||Points on a scale||Standard Error|Mean
1286651|NCT00168844|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|||Points on a scale||Standard Error|Mean
1286652|NCT00168844|Primary|Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)|Trough Forced Expiratory Volume in 1 second (FEV1)|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286653|NCT00168831|Secondary|PGR Scores|Patient's Global rating (PGR) scores over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.|Week 48|Full Analysis Set - Patient's Global Rating (FAS-PGR)|||Points on a scale||Standard Error|Mean
1286654|NCT00168831|Secondary|PGE Scores|Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value.|Week 48|Full Analysis Set - Physician's Global Evaluation (FAS-PGE)|||Points on a scale||Standard Error|Mean
1286655|NCT00168831|Secondary|COPD Symptoms Scores|"COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period.~Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - COPD symptoms (FAS-SYM)|||Points on a scale||Standard Error|Mean
1286656|NCT00168831|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Scores|"Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|||Points on a scale||Standard Error|Mean
1286657|NCT00168831|Secondary|Mahler TDI Scores|"Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.~Worst score = -3, best score = +3"|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)|||Points on a scale||Standard Error|Mean
1286658|NCT00168831|Secondary|Weekly Mean Number of Puffs of Rescue Medication Per Day|Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Puffs||Standard Error|Mean
1286659|NCT00168831|Secondary|Weekly Mean Morning Evening PEFRs|Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Litres/minute||Standard Error|Mean
1286660|NCT00168831|Secondary|Weekly Mean Morning Pre-dose PEFRs|Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Litres/minute||Standard Error|Mean
1286661|NCT00168831|Secondary|Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286662|NCT00168831|Secondary|Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286663|NCT00168831|Secondary|Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks|Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286664|NCT00168831|Secondary|Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286665|NCT00168831|Secondary|Change From Baseline in Albumin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||g/L||Standard Deviation|Mean
1286666|NCT00168831|Secondary|Change From Baseline in Protein, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||grams per litre (g/L)||Standard Deviation|Mean
1286667|NCT00168831|Secondary|Change From Baseline in Uric Acid|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||umol/L||Standard Deviation|Mean
1286668|NCT00168831|Secondary|Change From Baseline in Bilirubin, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||umol/L||Standard Deviation|Mean
1286669|NCT00168831|Secondary|Change From Baseline in Creatinine|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||micromoles per litre (umol/L)||Standard Deviation|Mean
1286670|NCT00168831|Secondary|Change From Baseline in Blood Urea Nitrogen|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||milligrams per decilitre (mg/dL)||Standard Deviation|Mean
1286671|NCT00168831|Secondary|Change From Baseline in Urea|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
1286672|NCT00168831|Secondary|Change From Baseline in Glucose|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
1286673|NCT00168831|Secondary|Change From Baseline in Lactic Dehyrogenase (LDH)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
1286674|NCT00168831|Secondary|Change From Baseline in Alkaline Phosphatase|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
1286675|NCT00168831|Secondary|Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
1286676|NCT00168831|Secondary|Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||Units per litre (U/L)||Standard Deviation|Mean
1286677|NCT00168831|Secondary|Change From Baseline in Phosphate|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
1286694|NCT00168831|Secondary|Change From Baseline in VPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||pairs per 24 hours||Standard Deviation|Mean
1286695|NCT00168831|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||events per 24 hours||Standard Deviation|Mean
1286696|NCT00168831|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||premature beats per 24 hours||Standard Deviation|Mean
1286697|NCT00168831|Secondary|Change From Baseline in SVPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||pairs per 24 hours||Standard Deviation|Mean
1286698|NCT00168831|Secondary|Change From Baseline in SVPB Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||events per 24 hours||Standard Deviation|Mean
1286699|NCT00168831|Secondary|Change From Baseline in Supraventricular Premature Beat (SVPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||premature beats per 24 hours||Standard Deviation|Mean
1286700|NCT00168831|Secondary|Change From Baseline in Heart Rate|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||bpm||Standard Deviation|Mean
1286701|NCT00168831|Secondary|Change From Baseline in QT Interval (Fridericia)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
1286702|NCT00168831|Secondary|Change From Baseline in QT Interval (Bazett)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
1286703|NCT00168831|Secondary|Change From Baseline in QT Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
1286704|NCT00168831|Secondary|Change From Baseline in QRS Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
1286705|NCT00168831|Secondary|Change From Baseline in PR Interval||Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||milliseconds (msec)||Standard Deviation|Mean
1286706|NCT00168831|Secondary|Change From Baseline in Heart Rate|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||beats per minute (bpm)||Standard Deviation|Mean
1286707|NCT00168831|Primary|COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)|"Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year~For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined."|48 weeks|Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively.|||Number of exacerbations per patient year||Standard Deviation|Mean
1286708|NCT00168831|Primary|TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)|"Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9~For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined."|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)|||Points on a scale||Standard Error|Mean
1286709|NCT00168831|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|||Points on a scale||Standard Error|Mean
1286710|NCT00168831|Primary|Change From Baseline in Trough FEV1 After 48 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
1286711|NCT00168818|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients|||participants|||Number
1286712|NCT00168818|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1||||mL||Standard Deviation|Mean
1286713|NCT00168818|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 1||||participants|||Number
1286729|NCT00168805|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op|||Participants|||Number
1286714|NCT00168818|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 31-38 days|Treated set|||Participants|||Number
1286715|NCT00168818|Secondary|Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|end of treatment to day 91±7|Patients with any data available during follow-up|||Participants|||Number
1286716|NCT00168818|Secondary|Death During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
1286717|NCT00168818|Secondary|Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
1286718|NCT00168818|Secondary|Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
1286719|NCT00168818|Secondary|Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
1286720|NCT00168818|Secondary|Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
1286721|NCT00168818|Secondary|Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)|||Participants|||Number
1286722|NCT00168818|Primary|Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 31-38 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)|||Participants|||Number
1286723|NCT00168805|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients|||participants|||Number
1286724|NCT00168805|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1||||mL||Standard Deviation|Mean
1286725|NCT00168805|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 1||||participants|||Number
1286726|NCT00168805|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 6-10 days|Treated set|||Participants|||Number
1286727|NCT00168805|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up|||Participants|||Number
1286813|NCT00167544|Secondary|Duration of Positive Pressure Support (Mechanical Ventilation or Continuous Positive Airway Pressure)||Up to 36 weeks PMA||||days||95% Confidence Interval|Mean
1286730|NCT00168805|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
1286731|NCT00168805|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
1286732|NCT00168805|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
1286733|NCT00168805|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)|||Participants|||Number
1286734|NCT00168805|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 6-10 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)|||Participants|||Number
1286735|NCT00168454|Post-Hoc|Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes|Measured by the 7 day diary preceding each visit. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.|Baseline, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36|Intent to Treat|||Percentage of patients|||Number
1286736|NCT00168454|Secondary|Incontinence Quality of Life Instrument (I-QOL)|Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.|Baseline, Week 2, Week 6, Week 12|Intent to Treat|||Units on a scale|||Number
1286737|NCT00168454|Secondary|Maximum Cystometric Capacity (MCC) by Urodynamic Measurements|Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters|Baseline, Week 12|Intent to Treat|||milliliters|||Number
1286738|NCT00168454|Secondary|Change in Number of Nocturia Episodes|Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.|Baseline, Week 12|Intent to Treat|||episodes|||Number
1286739|NCT00168454|Secondary|Change in Number of Micturitions|Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.|Baseline, Week 2, Week 6, Week 12|Intent to Treat|||micturitions|||Number
1286740|NCT00168454|Primary|Change in Number of Urinary Urge Incontinence Episodes|Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.|Baseline, Week 2, Week 6, Week 12|Intent to Treat|||episodes|||Number
1286741|NCT00168428|Secondary|Percentage of Patients With Severe HIT-6 Impact Category Scores|Percentage of patients with a severe (60-78) score on the Headache Impact Test (HIT-6) Questionnaire during the 28 day period, ending with Week 24. The HIT-6 consisted of 6 questions about headache and impact on the patient's health and well-being. Answers for each question ranged from 6=Never, 8=Rarely, 10=Sometimes, 11=Very Often, and 13=Always. The total scores ranged from 36-49 (Little or No Impact), 50-55 (Some Impact), 56-59 (Substantial Impact) and 60-78 (Severe Impact).|Week 24|Intent to Treat|||Percentage of Patients|||Number
1286742|NCT00168428|Secondary|Change in Frequency of Headache Episodes|Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.|Baseline, Week 24|Intent to Treat|||Headache Episodes||Standard Deviation|Mean
1286743|NCT00168428|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Days|Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting the ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat|||Migraine/Probable Migraine Headache Days||Standard Deviation|Mean
1286744|NCT00168428|Secondary|Change in Frequency of Moderate/Severe Headache Days|Mean change from baseline in frequency (number) of moderate/severe headache days during the 28 day period ending with Week 24. Those calendar days with >= 4 continuous hours of headache were selected. As per the patient diary, all headache episodes occurring during those days with a maximum severity of moderate or severe were counted.|Baseline, Week 24|Intent to Treat|||Moderate/Severe Headache Days||Standard Deviation|Mean
1286745|NCT00168428|Secondary|Change in Total Cumulative Hours of Headache Occurring on Headache Days|Mean change from baseline in total cumulative hours of headache occurring on headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] when the patient reported >= 4 continuous hours of headache.|Baseline, Week 24|Intent to Treat|||Hours||Standard Deviation|Mean
1289140|NCT00135707|Secondary|Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)|HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.|20 weeks through discharge following delivery||||Participants|||Count of Participants
1286746|NCT00168428|Primary|Change in Frequency of Headache Days|Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache.|Baseline, Week 24|Intent to Treat|||Headache Days||Standard Deviation|Mean
1286747|NCT00168389|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1286748|NCT00168389|Secondary|10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.|Baseline, 39 Months|Intent to Treat: all randomized patients|||Days|||Number
1286749|NCT00168389|Secondary|Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. The average OCT retinal thickness is calculated across study visits for each patient. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients with data at the time point|||Microns||Standard Deviation|Mean
1286750|NCT00168389|Secondary|Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1286751|NCT00168389|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Letters||Standard Deviation|Mean
1286752|NCT00168389|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients|||Letters||Standard Deviation|Mean
1286753|NCT00168389|Primary|Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1286754|NCT00168337|Post-Hoc|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1286755|NCT00168337|Post-Hoc|10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.|Baseline, 39 Months|Intent to Treat: all randomized patients|||Days|||Number
1286756|NCT00168337|Secondary|Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Microns||Standard Deviation|Mean
1286757|NCT00168337|Secondary|Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1286758|NCT00168337|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Letters||Standard Deviation|Mean
1286759|NCT00168337|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients|||Letters||Standard Deviation|Mean
1286760|NCT00168337|Primary|Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1286761|NCT00168324|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 180|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1286762|NCT00168324|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 90|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1286763|NCT00168324|Primary|Cumulative Response Rate of 15 or More Letter Improvement|The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.|Up to 180 Days|Intent-to-Treat: all randomized patients|||Kaplan-Meier Estimate|||Number
1286764|NCT00168324|Secondary|Change From Baseline in Retinal Thickness in the Study Eye|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Day 90, Day 180|Intent-to-Treat: all randomized patients|||Microns (µm)||Standard Deviation|Mean
1286765|NCT00168324|Secondary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.|Day 90, Day 180|Intent-to-Treat: all randomized patients|||Number of Participants|||Number
1286766|NCT00168311|Primary|Scale for the Asessment of Negative Symptoms (SANS)|Scale for Assessment of Negative Symptoms [SANS]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of >50 is considered to be a moderate-severe intensity.|3 weeks||||Scores on a scale||Standard Deviation|Mean
1286767|NCT00168298|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 180|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1286768|NCT00168298|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 90|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1286769|NCT00168298|Secondary|Change From Baseline in Retinal Thickness in the Study Eye|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Day 90, Day 180|Intent-to-Treat: all randomized patients|||Microns (µm)||Standard Deviation|Mean
1286770|NCT00168298|Primary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|Day 180|Intent-to-Treat: all randomized patients|||Number of Participants|||Number
1286771|NCT00168103|Secondary|Number of Vomiting Episodes||Within 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Episodes per subject||Full Range|Median
1286772|NCT00168103|Other Pre-specified|Number of Subjects Receiving Rescue Study Medication||Within 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Subjects|||Number
1286773|NCT00168103|Other Pre-specified|Time to Complete Resolution of All HAE Symptoms, Including Pain|Complete resolution of symptoms was determined by subject self-assessment.|Up to 24 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Hours||Full Range|Median
1286774|NCT00168103|Secondary|Number of Subjects With Worsened Intensity of Clinical HAE Symptoms|Includes any worsening of intensity of at least 1 of the HAE symptoms present at baseline. Routinely checked symptoms included pain, nausea, vomiting, cramps, and diarrhea.|Baseline and between 2 and 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Subjects|||Number
1286775|NCT00168103|Primary|Time to Start of Relief of Symptoms From HAE Attack|The start of symptom relief was determined by subject self-assessment. Time to start of symptom relief was set to 24 hours if the subject received rescue medication (blinded study medication, narcotic analgesics, antiemetics, open-label C1-INH, or fresh frozen plasma) at any time point after the start of study treatment but before start of relief.|Up to 24 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Hours||Full Range|Median
1286776|NCT00168064|Secondary|Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)|Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart.|Baseline to end of therapy||||Percent of participants|||Number
1286777|NCT00168064|Secondary|Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks||Assessment made at Day 1 and every subsequent visit during treatment|||||||
1286778|NCT00168064|Primary|Ratio of Response Rates Based on CAILS|The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment|Assessment made at Day 1 and every subsequent visit during treatment|ITT|||percentage of participants|||Number
1286779|NCT00168038|Secondary|Maximum Platelet Level|Maximum absolute platelet count achieved over the duration of the study.|29 days|ITT analysis. The ITT population comprised all subjects who received at least once study medication.|||10^9/L||Full Range|Median
1286780|NCT00168038|Secondary|Duration of Platelet Response|The number of days the platelet count remained ≥ 50 x 10^9/L.|up to 29 days|Analyzed for responders in the ITT population, i.e., only subjects with at least one platelet measurement ≥ 50 x 10^9/L after start of treatment|||days|Participants|Inter-Quartile Range|Median
1286781|NCT00168038|Secondary|Time to Platelet Response|Median time to reach a platelet count ≥ 50 x 10^9/L.|29 days|ITT analysis. The ITT population comprised all subjects who received at least once study medication.|||days||Inter-Quartile Range|Median
1286782|NCT00168038|Secondary|Regression of Hemorrhage (Internal)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with internal bleeding at baseline and respective post-baseline assessment.|||participants|||Number
1286783|NCT00168038|Secondary|Regression of Hemorrhage (Nose)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with nose bleeding at baseline and respective post-baseline assessment.|||participants|||Number
1286784|NCT00168038|Secondary|Regression of Hemorrhage (Genitourinary Tract)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with genitourinary tract bleeding at baseline and respective post-baseline assessment.|||participants|||Number
1286785|NCT00168038|Secondary|Regression of Hemorrhage (Oral Cavity)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with oral cavity bleeding at baseline and respective post-baseline assessment.|||participants|||Number
1289526|NCT00129766|Primary|Number of Participants Who Discontinued Study Drug Due to AEs||Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
1286786|NCT00168038|Secondary|Regression of Hemorrhage (Skin)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|up to 29 days|The number of participants analyzed represents the number of subjects in the ITT population with skin bleeding at baseline and respective post-baseline assessment.|||participants|||Number
1286787|NCT00168038|Primary|Platelet Response|The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.|7 days|Intention to treat (ITT) analysis. The ITT population comprised all subjects who received at least once study medication.|||Percent of participants||95% Confidence Interval|Number
1286788|NCT00167778|Secondary|How Bothersome Was Your Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
1286789|NCT00167778|Secondary|Pain Interference With Activities?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
1286790|NCT00167778|Secondary|Least Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
1286791|NCT00167778|Secondary|Worst Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
1286792|NCT00167778|Secondary|Average Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
1286793|NCT00167778|Secondary|Residual Limb Pain at Present?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
1286794|NCT00167778|Secondary|Six-minute Walk Distance|Participants are asked to walk alone as far as possible without running for six minutes. This test is performed indoors along a long, flat straight hallway of approximately 30 meters in length with two orange cones marking the 180 degree turnaround points at each end of the corridor. Approximately 40 straight steps were taken for every four turning steps.|Six minutes after wearing the study prostheses for four weeks.|Each participant wore both study prostheses.|||m||Standard Error|Mean
1286795|NCT00167778|Secondary|Activity Level|Average number of steps per day over a 1 week period ending in the fourth week of each study prosthesis (Rigid and Torsion adapter)|One week|Each participant wore both study prostheses.|||Steps/day||Standard Error|Mean
1286796|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Ankle While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
1286797|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Knee While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
1286798|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Hip While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
1286799|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Ankle While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
1286800|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Knee While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
1286801|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Hip While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
1286802|NCT00167778|Primary|Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286814|NCT00167544|Secondary|Regional Brain Volumes|Cerebral white matter volume|38-weeks postmenstrual age|In addition to the reasons cited for the primary outcome, one infant in the hydrocortisone group and two in the placebo group had artifacts on brain MRI precluding cerebral white matter segmentation and volume determination.|||cm^3||Standard Deviation|Mean
1286815|NCT00167544|Primary|Total Cerebral Volume as Measured by Volumetric Brain MRI|Total cerebral volume included all brain gray matter and white matter, including cerebellum.|38 weeks postmenstrual age (PMA)|Eight infants died in each group prior to term MRI precluding a determination of brain volumes. Additionally, four infants had poor quality MRI scans that could not be analyzed for brain volumes.|||cm^3||Standard Deviation|Mean
1286803|NCT00167778|Primary|Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286804|NCT00167778|Primary|Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286805|NCT00167778|Primary|Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286806|NCT00167778|Primary|Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286807|NCT00167778|Primary|Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286808|NCT00167778|Primary|Local Dynamic Stability (Ankle During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286809|NCT00167778|Primary|Local Dynamic Stability (Knee During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286810|NCT00167778|Primary|Local Dynamic Stability (Hip During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
1286811|NCT00167544|Secondary|Survival Without Severe Bronchopulmonary Dysplasia (BPD)|Using the NIH Consensus definition (Jobe A, 2001)|36 weeks postmenstrual age||||participants|||Number
1286812|NCT00167544|Secondary|Duration of Oxygen Requirement||Up to 36 weeks PMA||||days||95% Confidence Interval|Mean
1286817|NCT00167414|Secondary|Percent of Patients With Lesion Local Control|Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure.|6 years||||percentage of participants|||Number
1286818|NCT00167414|Primary|Overall Survival|The percent of patients that survived from date of enrollment until 6 year follow-up visit|6 years||||percentage of participants|||Number
1286819|NCT00167414|Primary|Overall Survival|The percent of patients that survived from date of enrollment until 4 year follow-up visit|4 years||||percentage of participants|||Number
1286820|NCT00167414|Primary|Overall Survival|The percent of patients that survived from date of enrollment until 2 year follow-up visit.|2 years||||percentage of participants|||Number
1286821|NCT00167388|Primary|Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States|Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion|1 hour|the number below represents the change in the parameter with feeding while the baby anemic (pre-transfusion)|||cm/sec||Standard Deviation|Mean
1286822|NCT00167310|Secondary|Plasma Cholesterol Levels in Various Lipoprotein Fractions|Biochemical Measures: Plasma levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Lp(a) cholesterol, IDL-cholesterol, HDL3-cholesterol, VLDL1,2-cholesterol, and VLDL3-cholesterol.|4 months||||mg/dL||Standard Deviation|Mean
1286823|NCT00167310|Primary|Plasma Levels of Triglycerides and Lipoprotein Cholesterol|Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.|4 months|Plasma triglyceride levels|||mg/dL||Standard Deviation|Mean
1286824|NCT00167245|Secondary|The Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale During the Medication Treatment Phase, Compared to Placebo-treated Subjects.||13 weeks|||||||
1286825|NCT00167245|Secondary|Days Abstinent From Drinking, Frequency of Heavy Drinking Days, and Cocaine Use (Confirmed by Urine Drug Screen) as Measured by the Time Line Follow-Back During the Treatment Phase, Compared to Less Topiramate-adherent (<80% Pills Taken).||13 weeks|||||||
1286826|NCT00167245|Secondary|Fewer Days of Cocaine Use as Measured by the Time Line Follow Back in the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.||12 weeks|||||||
1286827|NCT00167245|Secondary|Days Abstinent From Drinking and Frequency of Heavy Drinking Days as Measured by the Time Line Follow-Back During the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.||12 weeks|||||||
1286828|NCT00167245|Primary|Number of Heavy Drinking Days|Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women|13 weeks||||number of heavy drinking days||Standard Error|Mean
1286829|NCT00167245|Primary|Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial|Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.|Last 3 weeks of 13 week trial||||Percent of participants|||Number
1286830|NCT00167206|Secondary|Number of Patients Alive at 2 Years|Calculated from Day 1 of hematopoietic cell transplant to 2 years post-transplant.|2 years after transplant||||Participants|||Number
1286831|NCT00167206|Secondary|Number of Patients Alive at 1 Year|Calculated from Day 1 of hematopoietic cell transplant to 1 year post-transplant.|1 year after transplant||||Participants|||Number
1286832|NCT00167206|Secondary|Immune Reconstitution - Mean Value (2 Years)|Calculated mean value of patient CD4 values collected at intervals from Day 30 through 2 years post-transplant.|at 2 years after transplant||||Number of CD4 cells per microliter||Standard Deviation|Mean
1286833|NCT00167206|Secondary|Immune Reconstitution - Mean Value (1 Year)|Calculated mean value of patient CD4 values collected at intervals from Day 30 through 1 year post-transplant.|1 year post-transplant.||||Number of CD4 cells per microliter||Standard Deviation|Mean
1286834|NCT00167206|Secondary|Number of Patients Who Exhibited Regimen-related Toxicity (RRT)|Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. Regimen-related toxicity involves harmful effects in an organism through exposure to the treatment given.|1 year after hematopoietic cell transplant||||Participants|||Number
1286835|NCT00167206|Secondary|Number of Patients With Chronic Graft Versus-Host Disease (GVHD)|"Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack."|1 year after hematopoietic cell transplant||||Participants|||Number
1286836|NCT00167206|Secondary|Number of Patients With Acute Graft Versus-Host Disease (aGVHD)|"Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack."|Day 100 after hematopoietic cell transplant||||Participants|||Number
1286837|NCT00167206|Secondary|Number of Patients Who Exhibited Secondary Graft Failure|Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. A complication after Bone Marrow Transplant in which the transplanted stem cells do not grow in the recipient’s bone marrow and thus do not produce new blood cells.|Day 100 after hematopoietic cell transplant||||Participants|||Number
1286838|NCT00167206|Primary|Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment|Calculated from Day 1 of hematopoietic cell transplant to Day 42 post-transplant. Hematopoietic recovery and engraftment is defined as the first of three consecutive days the patient's absolute neutrophil count is greater than or equal to 0.5X10^9/Liter.|Day 42 after hematopoietic cell transplant||||Participants|||Number
1286839|NCT00167180|Secondary|Number of Patients With Bone Marrow Aplasia|"Aplastic anemia is a disorder in which the bone marrow greatly decreases or stops production of blood cells.~In aplastic anemia, the basic structure of the marrow becomes abnormal, and those cells responsible for generating blood cells (hematopoietic cells) are greatly decreased in number or absent. These hematopoietic cells are replaced by large quantities of fat."|Day 100||||Participants|||Count of Participants
1286842|NCT00167180|Secondary|Number of Patients Alive Without Disease|The number of patients alive one year after treatment without any signs or symptoms of the cancer being treated or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.|1 Year||||Participants|||Count of Participants
1286843|NCT00167180|Primary|Number of Patients Alive|"The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.~Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive."|1 Year||||Participants|||Count of Participants
1286844|NCT00167102|Primary|Number of Adverse Events|Number of any adverse event reported throughout the study, regardless of relation to study drug|24 weeks||||adverse events|||Number
1286845|NCT00167102|Primary|The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values|Assess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept followed by a 12 week observation period in subjects with chronic severe scalp alopecia|24 weeks||||percentage of participants|||Number
1286846|NCT00166712|Secondary|Patient and Graft Survival Rates at 6 and 12 Months Post-transplant||At 6 & 12 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.||||||
1286847|NCT00166712|Secondary|Incidence of Donor Specific Hyporesponsiveness Allowing for the Conversion to Monotherapy|The proportion of subjects for both groups determine this measure: 1) Patients in tacrolimus arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesonsiveness at 9 months post-transplant (those staying on TAC+MMF) or 3 months post-convertion (converted from TAC+MMF to Sirolimus+MMF) will be weaned to MMF monotherapy; 2) Those in the sirolimus+MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.|At 6 & 9 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.||||||
1286848|NCT00166712|Secondary|Renal Function at 12 Months Post-transplant|Laboratory tests for renal function include creatinine or iothalamate glomerular filtration rate (GFR).|At 12 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.||||||
1286849|NCT00166712|Secondary|Severity of Acute Rejection During the First 6 and 12 Months Post-transplant|The diagnosis of rejection will be based on clinical symptoms and signs, laboratory tests, and confirmed by core renal allograft biopsy.|Months 6-12 post-transplant|Study was terminated due to efficacy and there is no data was collected for this outcome measure.||||||
1286850|NCT00166712|Primary|The Incidence of Biopsy-proven Acute Allograft Rejection During the First 12 Months of Transplant.|The incidence of rejection is determined by the proportion of patients experiencing biopsy proven acute allograft rejection during the first 12 months post-transplant.|Within 12 months post kidney transplant|33 total subjects reached the 12 month participation mark.|||Participants|||Number
1286851|NCT00166517|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A|"Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in~SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3"|Baseline and 14 days Postdose 3|Per Protocol Population|||Participants|||Number
1286852|NCT00166517|Primary|Serum Anti-Rotavirus IgA Response|"Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in~Serum IgA 14 days Postdose 3"|Baseline and 14 days Postdose 3|Per Protocol Population|||Participants|||Number
1286853|NCT00166504|Primary|LDL-C Lowering Efficacy|LDL-C = low density lipoprotein cholesterol, measured in mg/dl.|6 weeks|Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point.|||Percent Change from Baseline||Standard Deviation|Least Squares Mean
1286854|NCT00166361|Primary|Mean Stent Dwell Time|Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.|baseline to 59 months after placement of stent||||months||Full Range|Mean
1286855|NCT00166296|Secondary|Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.|"The Hospital Anxiety and Depression Scale (HADS) is 14-item scale, patient-administered, that allows two independent scores of depression and anxiety. It has been specially designed to apply in patients with comorbid medical conditions as it excludes somatic or vegetative symptoms from the depression subscale.~We present data of de depression subscale. The seven-item Depression subscale yields a score of 0–21, with higher scores meaning higher levels of depressive symptoms."|12 weeks after interferon treatment onset||||Scores on a Scale||Standard Error|Mean
1286856|NCT00166296|Secondary|Total Score in the Montgomery-Asberg Depression Rating Scale|"The MADRS is a 10-item scale, clinician-administered, which is sensitive to symptom change during antidepressant treatment. It has been frequently used to measure depressive symptoms during interferon-alpha therapy and exhibits improved internal consistency in patients with co-morbid medical conditions compared with other clinician-administered questionnaires.~Items are rated on a scale of 0–6. Scores range from 0 to 60, higher scores meaning higher levels of depression."|12 weeks after interferon treatment onset||||Scores on a scale||Standard Error|Mean
1286857|NCT00166296|Primary|Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).|"Number of participants with negativization of serum hepatitis C Virus Ribonucleic Acid (HCV RNA) 6 months after concluding antiviral therapy (sustained viral response).~Negativization was defined as the absence of detectable levels of serum HCV RNA using a polymerase chain reaction."|Six months after the end of interferon treatment|Patients with available data for viral response 6 months after completion of interferon treatment were compared between treatment groups.|||Participants|||Number
1286875|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of fluconazole and Tetraethylammonium (TEA) administration. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from FBF after fluconazole administration and after Tetraethylammonium (TEA) administration.|5 minutes, 10 minutes|Only 19 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
1286858|NCT00166296|Primary|Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.|"At least five of the symptoms have been present during the same 1-week period: depressed mood, loss of interest or pleasure, weight or appetite changes, insomnia, agitation or retardation, fatigue, feelings of worthlessness or guilt, diminished ability to think or concentrate, recurrent thoughts of death.~At least one of the symptoms is either depressed mood or loss of interest. Diagnoses were made by a trained psychiatrist who applied the mood disorders module from the Structured Clinical Interview for DSM-IV Axis I Disorders, non-patient edition (SCID-I/NP) at each study evaluation."|First three months of interferon treatment.|One of 67 patients allocated to the escitalopram group and 3 of 66 in placebo did not receive the first dose of study medications. Consequently, 66 patients treated with escitalopram and 63 with placebo were included in the intention to treat analysis, with a procedure of last observation carried forward (LOCF).|||Participants|||Number
1286859|NCT00166205|Secondary|Changes in Total Cholesterol|Changes in Total Cholesterol, at three-years post-operative minus baseline.|3 years||||Mg/dl||Standard Deviation|Mean
1286860|NCT00166205|Secondary|Changes in Low Density Lipoproteins (LDL)|Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.|3 years||||Mg/dl||Standard Deviation|Mean
1286861|NCT00166205|Secondary|Changes in High Density Lipoproteins (HDL)|Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.|3 year||||Mg/dl||Standard Deviation|Mean
1286862|NCT00166205|Primary|Percent Excess Weight Loss|Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.|3 Years Post Operative|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)|||Percent Excess Weight Loss||95% Confidence Interval|Mean
1286863|NCT00166205|Secondary|Number of All Adverse Events of Subjects Implanted With the SAGB|The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device).|3 Years||||Total Number of Adverse Events|||Number
1286864|NCT00166205|Secondary|Changes in Glycosylated Hemoglobin (HbA1c)|Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.|3 years||||Percent of total hemogloobin||Standard Deviation|Mean
1286865|NCT00166205|Secondary|Changes in Quality of Life (QOL) Measures|Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.|3 years||||Units on a scale||Standard Deviation|Mean
1286866|NCT00166205|Secondary|Change in Absolute Weight|Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.|3 years||||Pounds||Standard Deviation|Mean
1286867|NCT00166205|Secondary|Changes in Body Mass Index (BMI)|Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.|3 years||||kg/m2||Standard Deviation|Mean
1286868|NCT00166205|Secondary|Changes in Excess Body Weight (EBW)|Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.|3 years||||Pounds||Standard Deviation|Mean
1286869|NCT00166205|Primary|Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)|Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period.|3 years|Intent to Treat (ITT)|||Percent of Subjects|||Number
1286870|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole, Tetraethylammonium (TEA), and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min|60 minutes, 90 minutes|Only 10 of the original 174 subjects were treated for this portion of the study.|||ng/mL||Standard Error|Mean
1286871|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and t-PA after bradykinin 400 ng/min|30 minutes, 60 minutes|Only 11 of the original 174 subjects were treated for this portion of the study.|||ng/mL||Standard Error|Mean
1286872|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after Tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min|30 minutes, 60 minutes|Only 18 of the original 174 subjects were treated for this portion of the study.|||ng/mL||Standard Error|Mean
1286873|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA at baseline and t-PA after bradykinin 400 ng/min|Baseline, 30 minutes|Only 33 of the original 174 subjects were treated for this portion of the study.|||ng/mL||Standard Error|Mean
1286874|NCT00166166|Secondary|Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of sodium nitroprusside. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed.|5 minutes|Only 80 of the original 174 subjects were treated for this portion of the study.|||mL min^-1 * 100 mL^-1||Standard Error|Mean
1286913|NCT00165698|Secondary|Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMC||Full Range|Median
1286876|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after L-NMMA administration and administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF after L-NMMA administration and then fluconazole administration.|5 minutes, 10 minutes|Only 15 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
1286877|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after fluconazole administration.|Baseline, 5 minutes|Only 33 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
1286878|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA)|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from after L-NMMA administration and after TEA administration.|5 minutes, 10 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
1286879|NCT00166166|Primary|Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA)|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from baseline and after L-NMMA administration.|Baseline, 5 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
1286880|NCT00166166|Primary|Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after TEA administration.|Baseline, 5 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
1286881|NCT00166114|Primary|Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8|"Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.~The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:~No Response = < 25% change in Depression Rating Scale Score Partial Responder = < 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score"|Baseline, Week 8||||participants|||Number
1286882|NCT00166036|Secondary|Change in Flow-mediated Dilatation (FMD)|Flow-mediated dilatation (FMD) of the brachial artery was used to asses Endothelial Function. The endothelium, by releasing nitric oxide (NO), promotes vasodilation and inhibits inflammation, thrombosis, and vascular smooth muscle cell proliferation.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.|Baseline & 12 Weeks||||Percentage of brachial artery diameter||Standard Error|Mean
1286883|NCT00166036|Primary|Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels|Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.|Baseline &12 Weeks||||nmol/mL||Standard Error|Mean
1286884|NCT00165984|Primary|Survival|Follow-up study designed to determine the impact of genetic factors on survival in single ventricle patients|7 yr mean follow-up|All patients enrolled were genotyped|||percentage of patients alive/nontrans|||Number
1286885|NCT00165984|Primary|To Evaluate the Incidence of the Pre-proendothelin SNP at Nucleotide 5665||7 years|165 enrolled patients were analyzed for this polymorphism|||participants|||Number
1286886|NCT00165958|Primary|Number of Participants With Cyst Recurrence|Recurrence of cyst after removal|16 months||||participants|||Number
1286887|NCT00165841|Secondary|The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase|The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month|6-month maintenance phase|||||||
1286888|NCT00165841|Secondary|The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase|The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase|6-month maintenance phase|||||||
1286914|NCT00165698|Secondary|Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMC||Full Range|Median
1286915|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMD||Full Range|Median
1286916|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMD||Full Range|Median
1286889|NCT00165841|Primary|The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population).|The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.|6 months double-blind maintenance phase|Intent-to-treat (ITT) population, total 187 subjects, was used for efficacy analyses. Safety population (total 200 subjects) was used for safety analysis and participant flow.|||Percentage of Days||Standard Deviation|Mean
1286890|NCT00165789|Primary|Number of Participants With Any TEAE|Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section.|Through end of study|Safety Population was the primary population for analysis defined as all subjects who completed the Baseline Phase and who received at least 1 dose of double-blind study medication.|||Participants|||Number
1286891|NCT00165789|Secondary|Duration of Dyskinesia From UPDRS at Baseline and Day 70|The duration of dyskinesia was determined from question 32 (part 4) of the UPDRS assessment. It asks what proportion of the waking day are dyskinesias present, and uses a 5-part scale: 0 = None, 1 = 1-25% of day, 2 = 26-50% of day, 3 = 51-75% of day, 4 = 76-100% of day. Lower scores represented more normal functioning.|Baseline and Day 70|Safety Population|||Participants|||Number
1286892|NCT00165789|Secondary|Disability of Dyskinesia From UPDRS at Baseline and Day 70|The disability of dyskinesia was determined from question 33 (part 4) of the UPDRS assessment. It asks how disabling are the dyskinesias, and uses a 5-part scale: 0=Not disabling, 1=MIldly disabling, 2=Moderately disabling, 3=Severely disabling, 4=Completely disabling. Lower scores represented more normal functioning.|Baseline and Day 70|Safety Population|||Participants|||Number
1286893|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent on Time With Non-troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Percentage of the Day||Standard Deviation|Mean
1286894|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent on Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Percentage of the Day||Standard Deviation|Mean
1286895|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent Off Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Percentage of the Day||Standard Deviation|Mean
1286896|NCT00165789|Secondary|Change From Baseline to Day 70 in Goetz/Rush Score|The Goetz/Rush scale was used to rate severity during performance of tasks intended to elicit dyskinesias, and provided an objective rating of dyskinesias during activities of daily living.The tasks included a sitting exercise, mental calculations, drinking, dressing, and walking. A 5-point scale was used: 0=absent; 1=minimal severity, no interference with voluntary motor acts; 2=dyskinesias, may impair voluntary movements but the subject was capable of efficiently completing the motor task; 3=intense dyskinesias, interference with movement control and completion of the motor task was greatly limited; 4= violent dyskinesias, incompatible with the completion of the motor task. A lower score indicated less difficulty performing the tasks.|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Scores on a Scale||Standard Deviation|Mean
1286897|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute on Time With Troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Hours||Standard Deviation|Mean
1286917|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMD||Full Range|Median
1286898|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute on Time With Non-troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Hours||Standard Deviation|Mean
1286899|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute Off Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Hour||Standard Deviation|Mean
1286900|NCT00165789|Secondary|"Change From Baseline to Day 70 in on State of UPDRS Scores"|The Unified Parkinson's Disease Rating Scale (UPDRS) consisted of 4 subsections used to assess symptoms and signs of Parkinson's disease, with an overall scale range of 0-147. Individual subsections included: I. Mentation, behavior, and mood (0-16); II. Activities of daily living assessed in both the “on” and “off” state (0-52); III. Motor examination (0-56); and IV. Complications of therapy assessed in the “on” fluctuations and dyskinesias (0-23). Each subsection included subscales that ranged from 0 (best possible outcome) to 1 or 4 (worst possible outcome), with the total score of subsection equaling the sum of the scores of the subscales and the overall UPDRS score equaling the sum of the scores of the 4 subsections (higher score indicating more severe Parkinson's Disease).|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Scores on a Scale||Standard Deviation|Mean
1286901|NCT00165776|Secondary|Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment|Change from Baseline in Patient's Pain Assessment-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. The patient's assessment of pain was performed using a 100 mm VAS)ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline, Week 4|FAS|||Millimeters||Standard Error|Mean
1286902|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment|TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS|||Points on a Scale||Standard Error|Mean
1286903|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment|TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS|||Points on a Scale||Standard Error|Mean
1286904|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment|TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS|||Points on a Scale||Standard Error|Mean
1286905|NCT00165776|Primary|Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, Week 4|Full Analysis Set (FAS) population: All subjects who received study treatment|||Points on a Scale||Standard Error|Mean
1286906|NCT00165776|Secondary|Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment|Change from Baseline in PGA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Week 4|FAS|||Millimeters||Standard Error|Mean
1286907|NCT00165776|Secondary|Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment|"Change from Baseline in PtGA-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. Participants answered: Considering all the ways your cervical dystonia affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 4|FAS|||Millimeters||Standard Error|Mean
1286908|NCT00165698|Secondary|Height (Meter)||Baseline and 12 months|Per Protocol Set (PPS)|||meters||Standard Deviation|Mean
1286909|NCT00165698|Secondary|New Fracture and Fall||12 months|Per Protocol Set (PPS)|||participants|||Number
1286910|NCT00165698|Secondary|Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of UCOC/OC||Inter-Quartile Range|Median
1286911|NCT00165698|Secondary|Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of UCOC||Inter-Quartile Range|Median
1286912|NCT00165698|Secondary|Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of OC||Inter-Quartile Range|Median
1286918|NCT00165672|Primary|The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).|Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring.|Baseline and 4 weeks|The major endpoint of this study was analysed in the population for clinical pharmacology data (observation period and treatment period)|||Percent Time||Standard Deviation|Mean
1286919|NCT00165646|Primary|Percentage of Participants With Complete Relief of Heartburn at Final Evaluation|“Heartburn diary” will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days|4 weeks|The major endpoint of this study was between-group comparison of the complete relief of heartburn (at the completion of the treatment period) in the full analysis set (FAS).|||Percentage of participants|||Number
1286920|NCT00165503|Primary|Adjuvant Chemotherapy Completion Rate|Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.|Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.|None of the enrolled participants were evaluated for the primary endpoint since none received the experimental adjuvant chemotherapy per protocol.||||||
1286921|NCT00163657|Primary|Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure|Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence|12 month post transplant||||participants|||Number
1286922|NCT00163657|Primary|Freedom From Acute Rejection or HCV Recurrence or Treatment Failure|"Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"|12 months||||participants|||Number
1286923|NCT00163293|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||participants|||Number
1286924|NCT00163293|Secondary|Number of Participants With Clinically Significant Laboratory Values|Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin <9.5 g/dL; Erythrocytes <3.0 x 10^6/μL or >6.5 x 10^6/μL; White Blood Count <3000/mm^3 or >20000/mm^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose >2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase >3 times ULNR; Creatinine >1.5 times ULN; Potassium >5.0 mmol/L or <3.0 mmol/L; and Sodium >150 mmol/L or 130 mmol/L.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||participants|||Number
1286925|NCT00163293|Secondary|Number of Participants With Clinically Significant Physical Examination Findings|A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||participants|||Number
1286926|NCT00163293|Secondary|Number of Participants With Clinically Significant Vital Signs Findings|Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure >130 mmHg or <80 mmHg or a >20 mmHg difference from Baseline; Diastolic Blood Pressure > 85 mmHg; and Resting Heart Rate >140 bpm or <60 bpm or a >30 bpm difference from Baseline.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||participants|||Number
1286927|NCT00163293|Secondary|Quality of Life Assessments as Per Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)|The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby “1” indicated maximum impairment and “7” indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best).|Months 2, 6 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1286939|NCT00163293|Secondary|Percentage of Participants Who Dropped-out Due to Asthma Exacerbation||Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||percentage of participants|||Number
1287975|NCT00147199|Secondary|Trough 6MWD at Week 12|Change in 6MWD from Baseline to trough 6MWD at Week 12. Trough was defined as a 6MWT conducted at least 4 hours following study drug inhalation.|12 Weeks|Intention to treat population|||meters||Inter-Quartile Range|Median
1286928|NCT00163293|Secondary|Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])|The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where “1” indicated maximum impairment and “7” indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best).|Months 2, 6 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1286929|NCT00163293|Secondary|Percentage of Asthma Symptom Free Days|Days without Asthma Symptom documented in the participant's diary were reported.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percentage of days||Standard Deviation|Mean
1286930|NCT00163293|Secondary|Percentage of Rescue Medication Free Days|Days without use of rescue medication documented in the participant’s diary were reported.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percentage of days||Standard Deviation|Mean
1286931|NCT00163293|Secondary|Rescue Medication Use Per Day|Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant’s diary.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||puffs/day||Standard Deviation|Mean
1286932|NCT00163293|Secondary|Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms|Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percentage of nights||Standard Deviation|Mean
1286933|NCT00163293|Secondary|Total Asthma Symptom Score by Diary Entries|Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1286934|NCT00163293|Secondary|Change From Baseline in Diurnal PEF Fluctuation|Diurnal PEF Fluctuation is equal to [(Higher PEF – Lower PEF)/0.5*(Higher PEF + Lower PEF)] * 100%. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percent fluctuation||Standard Deviation|Mean
1286935|NCT00163293|Secondary|Change From Baseline in PEF by Diary Entries|PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||liters/second||Standard Deviation|Mean
1286936|NCT00163293|Secondary|Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries|PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||liters/second||Standard Deviation|Mean
1286937|NCT00163293|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)|FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percent predicted FEV1||Standard Deviation|Mean
1286938|NCT00163293|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)|FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||liters||Standard Deviation|Mean
1286940|NCT00163293|Secondary|Number of Exacerbations Per Participant|The mean number of asthma exacerbations per participant is reported.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||exacerbations||Standard Deviation|Mean
1286941|NCT00163293|Secondary|Duration of Exacerbations|Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||days||Standard Deviation|Mean
1286942|NCT00163293|Secondary|Mean Rate of Asthma Exacerbations Per Year|Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year).|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||number of exacerbations per year||Standard Deviation|Mean
1286943|NCT00163293|Secondary|Growth Velocity as Assessed by Stadiometric Height Measurement|Standing height measured in millimeters (mm) with a wall-mounted stadiometer.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||mm/year||Standard Deviation|Mean
1286944|NCT00163293|Primary|Exacerbations (Post-hoc Analysis of Annual Rates)|A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age [years] and race were identified to be important beside treatment. The parameters centre and age [years] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||number of events per year||Standard Error|Least Squares Mean
1286945|NCT00163293|Primary|Time to First Asthma Exacerbation|Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.|Up to 12 months|Intention to Treat (ITT) analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||days||Standard Error|Mean
1286946|NCT00163215|Secondary|Ratio of Bone Age (BA) to Chronological Age (CA)|BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray – Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies those participants evaluated at that time point.|||ratio||Standard Deviation|Mean
1286947|NCT00163215|Secondary|Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36|BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||years||Standard Deviation|Mean
1286948|NCT00163215|Secondary|Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36|BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||kg/m^2||Standard Deviation|Mean
1286949|NCT00163215|Secondary|Body Mass Index (BMI)|BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here “n” signifies those participants evaluated at that time point.|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
1286950|NCT00163215|Secondary|Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)|AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25). GR in SDS was calculated using Sempe reference means and SD for growth. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
1286959|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population|Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25).|Baseline, Month 12, Month 24, Month 36|PP analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||cm/year||Standard Deviation|Mean
1286951|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 12, Month 24|PP analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Standard Deviation|Mean
1286952|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population|Change in AGR SDS for CA derived by subtracting AGR SDS CA at baseline from Yx value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 12, Month 24|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Standard Deviation|Mean
1286953|NCT00163215|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36|Change in height SDS BA was derived by subtracting height SDS BA at baseline from Yx value. Height SDS BA (for both baseline and Yx) = (height–reference mean for BA)/reference SD for BA. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
1286954|NCT00163215|Secondary|Mean Height Standard Deviation Score (SDS) for Bone Age (BA)|Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
1286955|NCT00163215|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36|Change in height SDS CA was derived by subtracting height SDS CA at baseline from Yx value. Height SDS CA (for both baseline and Yx) = (height – reference mean for CA)/reference SD for CA. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement – Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
1286956|NCT00163215|Secondary|Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here “n” signifies those participants evaluated at that time point.|||SDS||Standard Deviation|Mean
1286957|NCT00163215|Secondary|Change From Baseline in Height at Month 12, Month 24 and Month 36|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||cm||Standard Deviation|Mean
1286958|NCT00163215|Secondary|Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, Month 24, Month 36|"ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here n signifies those participants evaluated at that time point."|||cm||Standard Deviation|Mean
1286993|NCT00163020|Primary|Newborn Periventricular Leukomalacia (PVL)|Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter.|measured in the first 28 days after birth.|The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participants for analysis was determined using an intention to treat protocol.|||participants|||Number
1288079|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [6 Months]||6 months||||percent apoptosis||Standard Deviation|Mean
1286960|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population|Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25).|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||centimeter per year (cm/year)||Standard Deviation|Mean
1286961|NCT00163215|Primary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 36|Per Protocol (PP) analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
1286962|NCT00163215|Primary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 36|Intent to Treat (ITT) set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
1286963|NCT00163189|Other Pre-specified|Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60|Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT).|Screening, Month 12, 24, 36, 48, 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||milli mole per liter (mmol/L)||Standard Deviation|Mean
1286964|NCT00163189|Other Pre-specified|Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels||Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1286965|NCT00163189|Other Pre-specified|Number of Participants Who Received Concomitant Medications||Baseline up to Month 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||participants|||Number
1286966|NCT00163189|Other Pre-specified|Number of Participants With at Least 1 Medical or Surgical History||Screening|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||participants|||Number
1286967|NCT00163189|Other Pre-specified|Number of Participants With Significant Changes in Physical Examinations|Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement;|Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||participants|||Number
1286968|NCT00163189|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs.|Baseline up to 28 days after last study treatment|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||participants|||Number
1286969|NCT00163189|Secondary|Ratio of Bone Age (BA) to Chronological Age (CA)|BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray – Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||ratio||Standard Deviation|Mean
1286970|NCT00163189|Secondary|Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60|BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||months||Standard Deviation|Mean
1286995|NCT00163020|Primary|Newborn Pneumonia|Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia|measure during the first 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(154))|||Twins|||Number
1286971|NCT00163189|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
1286972|NCT00163189|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 12, 24, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
1286973|NCT00163189|Secondary|Change From Baseline in Height at Month 12, 24, 36, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||cm||Standard Deviation|Mean
1286974|NCT00163189|Secondary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||kg/m^2||Standard Deviation|Mean
1286975|NCT00163189|Secondary|Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)|GR SDS CA Yx = (GR Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
1286976|NCT00163189|Secondary|Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)|GR SDS BA Yx = (GR Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand.|Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
1286977|NCT00163189|Secondary|Annual Growth Rate (AGR)|AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25). Yx refers to the value at particular timepoint x.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||cm/year||Standard Deviation|Mean
1286978|NCT00163189|Secondary|Mean Height Standard Deviation Score (SDS) for Bone Age (BA)|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
1286979|NCT00163189|Secondary|Mean Height|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||centimeters (cm)||Standard Deviation|Mean
1286994|NCT00163020|Primary|Newborn Intraventricular Hemorrhage Grade 3 or 4|"Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation.~Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension."|measured during the first 28 days after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (316) vs. babies born to mothers in placebo arm(152))|||Twins|||Number
1288080|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [6 Months]||6 months||||percent apoptosis||Standard Deviation|Mean
1286980|NCT00163189|Primary|Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 36|"PP analysis set included all participants (excluding a site with GCP issues) who received at least 1 dose of GH, had at least 1 subsequent rating of height, no major protocol violation till first 3 years post initiation of treatment and total GH treatment duration of 36 months or more. n=participants evaluable at the specified time point."|||SDS||Standard Deviation|Mean
1286981|NCT00163189|Primary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 36|"Full analysis set (FAS) included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||Standard Deviation Score (SDS)||Standard Deviation|Mean
1286982|NCT00163020|Primary|Perinatal Death|Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.|measured from randomization to 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(156))|||Twins|||Number
1286983|NCT00163020|Secondary|Participant Side Effects Requiring Cessation of Therapy|Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy.|anytime from initial injection to final injection at 34 weeks.|Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)|||participants|||Number
1286984|NCT00163020|Secondary|Participant Drop-out Rates|Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy).|any time from randomization to completion of final dose of study medication|Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)|||participants|||Number
1286985|NCT00163020|Secondary|Newborn Birthweight|Newborn Birthweight within the twins group was measure following delivery and noted in grams.|measure following delivery|Population analysed were twins from twin pregnancies (ie. active group 160 and placebo group 80)|||grams||Standard Deviation|Mean
1286986|NCT00163020|Secondary|Newborn Gestational Age (GA) at Delivery|Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth.|determined at the time of birth|Population analysed were total pregnant mothers with twin gestations (ie. active group 160 and placebo group 80)|||weeks of age for twin pregnancy||Standard Deviation|Mean
1286987|NCT00163020|Secondary|Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks|Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks)|noted at delivery|Population analysed were total pregnant mothers with triplet gestations (ie. active group 160 and placebo group 80)|||Triplet Pregnancies|||Number
1286988|NCT00163020|Secondary|Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks|Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks)|Gestational age noted at time of birth|Population analysed were total pregnancies of mothers with twin gestation (ie. active group 160 and placebo group 80)|||Twin Pregnancies|||Number
1286989|NCT00163020|Secondary|Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)|Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death).|measured as any event noted in the first 28 day following birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(155))|||Twins - Components of Neonatal Morbidity|||Number
1286990|NCT00163020|Primary|Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver|Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis).|measured during the first 28 days after delivery|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (274) vs. babies born to mothers in placebo arm(130))|||Twins|||Number
1286991|NCT00163020|Primary|Newborn Retinopathy of Prematurity (ROP)|Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.|measured during the first 28 day after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(145))|||Twins|||Number
1286992|NCT00163020|Primary|Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery|Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis.|measured in the first 28 days after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (315) vs. babies born to mothers in placebo arm(152))|||Twins|||Number
1286996|NCT00163020|Primary|Newborn Sepsis|Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics.|measured during the first week following birth|The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participated included were based on an intent to treat protocol.|||participants|||Number
1286997|NCT00163020|Primary|Use of Oxygen Therapy at 28 Days of Newborn Life|Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.|Measured at 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(150))|||Twins|||Number
1286998|NCT00163020|Primary|Newborn Respiratory Distress Syndrome (RDS)|"Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support.~Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher’s Exact Test was used.~Morbidity measures were based on live births with data available for the outcomes."|Measured from delivery until 30 days after baby was discharged from the hospital|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (319) vs. babies born to mothers in placebo arm(153))|||Twins|||Number
1286999|NCT00162981|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 7|MITT population, baseline evaluations compared to Week 7 evaluations.|||participants|||Number
1287000|NCT00162981|Primary|A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the 4-week maintenance period|MITT population|||Percent Reduction||Full Range|Median
1287001|NCT00162981|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 3|MITT population, baseline evaluations compared to Week 3 evaluations.|||participants|||Number
1287002|NCT00162981|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 4-week maintenance period||||Percent of participants|||Number
1287003|NCT00162981|Primary|Percent Reduction in Number of Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 4-week maintenance period|Modified Intention-to-Treat (MITT) populations consist of all randomized patients who received study medication and who have both a baseline and post-baseline measurement and have at least one measurement during the maintenance period.|||Percent Reduction||Standard Deviation|Mean
1287004|NCT00162942|Post-Hoc|Clinical Response Based on no Use of 5-Aminosylisalates During the Study|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who did not use 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
1287005|NCT00162942|Post-Hoc|Clinical Response Based on Use of 5-Aminosylisalates During the Study|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who used 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medication were considered a treatment failure.|||percentage of participants|||Number
1287006|NCT00162942|Post-Hoc|Clinical Response Based on No Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who have not used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
1287007|NCT00162942|Post-Hoc|Clinical Response Based on Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and previously used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
1287008|NCT00162942|Post-Hoc|Clinical Response in Subjects With a CDAI Score Less Than or Equal to 300|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and had a CDAI score less than or equal to 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
1287009|NCT00162942|Post-Hoc|Clinical Response in Subjects With a CDAI Score Greater Than 300|A clinical response is defined as a 70-point decrease in CDAI score.|Baseline to Week 12|All subjects who received at least one apheresis treatment session and had a CDAI score greater than 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
1287010|NCT00162942|Secondary|Mean Change in C-Reactive Protein||Baseline to week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 value or Last Observation Carried Forward was used for the analysis.|||milligrams/liter||Standard Deviation|Mean
1287011|NCT00162942|Secondary|Mean Change in Subject Global Rating|7-point,ordinal scale that measures the subject's state of Crohn's Disease from 0 (totally inactive) to 7 (as bad as it gets), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287012|NCT00162942|Secondary|Mean Change in Crohn's Disease Endoscopic Index of Severity|26-point,ordinal scale that assesses the severity of Crohn's Disease from 0 (least severe) to 26 (most severe), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|Endoscopic evaluations were to be performed at baseline and Week 12 on a subset of study subjects.|||units on a scale||Standard Deviation|Mean
1287013|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (WLQ Index)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287014|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Output Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287015|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287016|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Physical Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287017|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Time Management)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287018|NCT00162942|Secondary|Mean Change in EuroQol Score (Visual Analog Scale)|101-point, ordinal scale which measures non-disease specific health-related quality of life from 0 (Worst imaginable health state) to 100 (best imaginable health state)|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287019|NCT00162942|Secondary|Mean Change in EuroQol Score (Single Index)|A continuous scale that is a cardinal index of health from 0 (no impairment) to 1 (most impairment), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287020|NCT00162942|Secondary|Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)|193-point, ordinal scale measuring disease-specific quality of life from 32 (low quality of life) to 224 (high quality of life). Mean change= Week 12 Mean-Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287021|NCT00162942|Secondary|Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score|101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287022|NCT00162942|Secondary|Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score|101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
1287023|NCT00162942|Secondary|Clinical Response|Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12|Baseline to Week 12|All subjects who received at least one apheresis session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 CDAI score or Last Observation Carried Forward was used for the analysis. Subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
1287024|NCT00162942|Secondary|CDAI Score Change From Baseline|601-point, ordinal scale which quantifies the symptoms of patients with Crohn's Disease from 0 (complete remission) to 600 (most severe active disease). Mean change=Week 12 Mean CDAI-Baseline Mean CDAI|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score was used for the analysis. If no week 12 score, then the week 9 score was be used. If no week 9 score, the subject was considered a treatment failure.|||units on a scale||Standard Deviation|Mean
1287025|NCT00162942|Primary|Frequency and Severity of Adverse Events Through Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.|Baseline through Week 12 Visit|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.|||percentage of participants|||Number
1287026|NCT00162942|Primary|Clinical Remission|Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT was used for effectiveness analysis. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
1287027|NCT00162773|Primary|Changes in Free Serum IgE Levels From Baseline||baseline to 2 weeks|Data, if any, are not available as this study has been terminated as the PI has left the institution. The arms/groups were combined for the study due to the study's early termination and the PI's departure from the institution. Data obtained were from the IRB and are therefore not separated by arm. This is all that is available.||||||
1287028|NCT00162370|Secondary|Determine the Cost-effectiveness of Using Stress Echocardiography in Screening Peri- and Post-menopausal Women at Intermediate Risk for Coronary Artery Disease.||End of Study|||||||
1287029|NCT00162370|Secondary|Determine the Relative Values of Exercise Echocardiography, Exercise ECG Testing, Cardiac Peptides and Brachial Artery Reactivity for Identifying Patients at Risk of Cardiac Events.||End of Study|||||||
1287030|NCT00162370|Secondary|Determine the Value of Brachial Artery Reactivity for Identifying Patients With Cardiac Events During Follow-up.||End of Study|||||||
1287031|NCT00162370|Secondary|Determine the Value of Exercise Induced Changes in Levels of Cardiac Peptides; Brain Natriuretic Peptide (BNP) in Identifying Patients With Cardiac Events During Follow-up.||2 year or 5 year follow up|||||||
1287032|NCT00162370|Secondary|Percent of Subjects With Abnormal Stress ECG Testing for Identifying Patients With Major Adverse Cardiac Events (MACE)|Stress ECG test interpretation will be summarized using number and percentage of patients with normal and abnormal ECG with and without MACE|2 or 5 year follow up|Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up|||percent of MACE|||Number
1287033|NCT00162370|Primary|Percentage of Low to Intermediate Risk Patients Experiencing Future Major Adverse Cardiac Events (MACE)|Determine the prognostic value of stress echocardiography as a screening examination in peri- or post-meopausal female patients with an intermediate pre-test likelihood of coronary artery disease (CAD) to identify patients at higer risk of experiencing future cardiac events.|2 or 5 year follow up|Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up|||% of subjects with MACE|||Number
1287034|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287035|NCT00162266|Secondary|Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287036|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287037|NCT00162266|Secondary|Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287038|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287039|NCT00162266|Secondary|Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287040|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287041|NCT00162266|Secondary|Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287042|NCT00162266|Secondary|Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287062|NCT00162266|Primary|Mean Change From Baseline (BL) in IgM in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
1287043|NCT00162266|Secondary|Mean BL General Health Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287044|NCT00162266|Secondary|Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57.|BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287045|NCT00162266|Secondary|Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287046|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287047|NCT00162266|Secondary|Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287048|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287049|NCT00162266|Secondary|Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287063|NCT00162266|Secondary|Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period|Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||IU/mL||Standard Error|Mean
1287050|NCT00162266|Secondary|Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period|The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51.|Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287051|NCT00162266|Secondary|Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period|SF-36=PCS, MCS, & 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, & mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values & post-baseline (BL) values are presented for each post-BL visit & represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287052|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period|The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1287053|NCT00162266|Secondary|Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1287054|NCT00162266|Secondary|Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period|Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
1287055|NCT00162266|Secondary|Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period|Serum evaluations were carried out to evaluate participant serum CRP concentrations at baseline. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
1287056|NCT00162266|Secondary|Mean Change From Baseline in sIL2-r Over Time in OL Period|Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||pg/mL||Standard Error|Mean
1287057|NCT00162266|Primary|Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
1287058|NCT00162266|Secondary|Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period|Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||pg/mL||Standard Deviation|Mean
1287059|NCT00162266|Primary|Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
1287060|NCT00162266|Primary|Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
1287061|NCT00162266|Primary|Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
1287136|NCT00161382|Secondary|Barriers||Measured throughout the study|||||||
1287137|NCT00161382|Secondary|Perceived Norms||Measured throughout the study|||||||
1287138|NCT00161382|Secondary|Attitudes||Measured throughout the study|||||||
1287064|NCT00162266|Secondary|Baseline Level of Serum Rheumatoid Factor Over Time in OL Period|Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||IU/mL||Standard Deviation|Mean
1287065|NCT00162266|Secondary|Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period|The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units.|Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N =number of participants analyzed; n=the number of participants with measurements for that time point.|||Participants|||Number
1287066|NCT00162266|Secondary|Number of ACR 70 Responders in the OL Period|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.|||Participants|||Number
1287067|NCT00162266|Secondary|Number of ACR 50 Responders in the OL Period|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.|||Participants|||Number
1287068|NCT00162266|Secondary|Number of ACR 20 Responders in OL Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
1287069|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||ng/mL||95% Confidence Interval|Mean
1287070|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||ng/mL||95% Confidence Interval|Mean
1287071|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||ng/mL||95% Confidence Interval|Mean
1287072|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||pg/mL||95% Confidence Interval|Mean
1287073|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||pg/mL||95% Confidence Interval|Mean
1287074|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||IU/mL||95% Confidence Interval|Mean
1287075|NCT00162266|Secondary|Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region)|Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.|Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.|||participants|||Number
1287139|NCT00161382|Secondary|Self-efficacy||Measured throughout the study|||||||
1287076|NCT00162266|Primary|Baseline Immunoglobulin M (IgM) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 10.|Baseline (Day 0) and Days 360, 720,1080,1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
1287077|NCT00162266|Primary|Mean Change From Baseline (BL) in IgG Over Time in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
1287078|NCT00162266|Primary|Baseline Immunoglobulin G (IgG) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 8.|Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
1287079|NCT00162266|Secondary|Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region)|Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.|Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.|||participants|||Number
1287080|NCT00162266|Secondary|Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region||Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.|||titers||Standard Deviation|Geometric Mean
1287081|NCT00162266|Secondary|Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region||Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.|||titers||Standard Deviation|Geometric Mean
1287082|NCT00162266|Secondary|Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods||Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period)|Treated Participants|||participants|||Number
1287083|NCT00162266|Secondary|Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy||From the start of study up to 60 days post the end of the 12-month double-blind period|Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.|||Participants|||Number
1287084|NCT00162266|Primary|Mean Change From Baseline (BL) in IgA Over Time in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
1287085|NCT00162266|Primary|Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 6.|Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
1287086|NCT00162266|Primary|Number of Participants With AEs of Special Interest in OL Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest were those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion.|Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
1287087|NCT00162266|Primary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug.|Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
1287088|NCT00162266|Primary|Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period|The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics.|Day 360 to Day 3,060|All treated participants.|||Participants|||Number
1287089|NCT00162266|Secondary|Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy||From the start of study up to 60 days post the end of the 12-month double-blind period|Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.|||Participants|||Number
1287140|NCT00161382|Secondary|Knowledge||Measured throughout the study|||||||
1288318|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 2)||Baseline to Week 2|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287090|NCT00162266|Secondary|Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug.|From the start of study through the end of the double-blind period (at 12 months)|All treated participants|||Participants|||Number
1287091|NCT00162266|Secondary|Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360||Day 180, Day 360|All treated participants|||participants|||Number
1287092|NCT00162266|Secondary|Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360|A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100.|Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||Percentage of Change on mHAQ scale||Standard Error|Mean
1287093|NCT00162266|Secondary|Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score.|Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||units on a scale||Standard Error|Mean
1287094|NCT00162266|Secondary|Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360|Percentage change = 100*(Baseline value – value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])|Baseline, Day 360|Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.|||percentage change||Standard Error|Mean
1287095|NCT00162266|Secondary|Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180|Percentage change = 100*(Baseline value – value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])|Baseline, Day 180|Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.|||percentage change||Standard Error|Mean
1287096|NCT00162266|Secondary|ACR-N Area Under The Curve (AUC) on Day 180 and Day 360|The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N.|Baseline and Day 180; Baseline and Day 360||||percentage*days||Standard Error|Mean
1287097|NCT00162266|Secondary|ACR Numeric Values (ACR-N)|The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication|||units on a scale||Standard Deviation|Mean
1287098|NCT00162266|Secondary|Number of ACR 70 Responders in DB Period|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication|||Participants|||Number
1287099|NCT00162266|Secondary|Number of ACR 50 Responders in DB Period|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication|||Participants|||Number
1288096|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Age of Donor at HSCT|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||Years||Full Range|Median
1287100|NCT00162266|Secondary|Number of ACR 20 Responders in DB Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360|Participants who received at least 1 infusion of study medication|||Participants|||Number
1287101|NCT00162266|Primary|Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 180|Intent-to-treat population. Participants who discontinued the study due to lack of efficacy (ie, worsening rheumatoid arthritis) were considered ACR 20 nonresponders at all subsequent time points. For all subjects who discontinued for other reasons, their last ACR 20 response was carried forward.|||Participants|||Number
1287102|NCT00162136|Secondary|Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.|At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.||||Participants|||Number
1287103|NCT00162136|Secondary|Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level|Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)|through 72 hours after start of infusion|All participants treated at the 40 mg/m2 dose level.|||ng/mL||Standard Deviation|Mean
1287104|NCT00162136|Secondary|Hematology Results - Worst On-Study Grade|Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.||||Participants|||Number
1287105|NCT00162136|Secondary|Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.||||Participants|||Number
1287106|NCT00162136|Primary|Number of Participants With Dose Limiting Toxicities at Dose Level|Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion.|Measures taken at Cycle 01 (21-day cycle)|All treated participants|||participants|||Number
1287107|NCT00162123|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.|From day of first reinduction in current study to date of progression or death, whichever occurred first.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study|||Months||95% Confidence Interval|Median
1287108|NCT00162123|Secondary|Number of Participants With On-study Immune-related Adverse Events (irAEs)|irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.|From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study 10 mg/kg current study|||Participants|||Number
1287109|NCT00162123|Secondary|Percentage of Participants Surviving at 1, 1.5, and 2 Years|Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.|From first dose of study drug in parent study to up to 2 years after reinduction|All participants who received study drug as reinduction or extended maintenance from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study and those patients who were followed-up.|||Percentage of participants|||Number
1287110|NCT00162123|Secondary|Overall Survival (OS)|OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.|From first dose of study drug in parent study to death or date of last censoring.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study|||Months||95% Confidence Interval|Median
1288262|NCT00144339|Secondary|Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)|From Day 1 to 4 years||||days/patient year||Standard Error|Mean
1287111|NCT00162123|Primary|Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study|||Participants|||Number
1287112|NCT00162097|Secondary|Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1)|The physical examination included an evaluation of the participant's height and body mass index (BMI) (at screening only), and weight. Abnormal physical examination are findings that are clinically meaningful by the judgment of the investigator|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis. Physical examination findings were not analysed at discharge.|||participants|||Number
1287113|NCT00162097|Secondary|Number of Participants With Clinically Meaningful Vital Signs Measures|Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. The investigator used his/her clinical judgement to decide whether or not abnormalities in vital signs were clinically meaningful.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis.|||participants|||Number
1287114|NCT00162097|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.|||hours||Full Range|Median
1287115|NCT00162097|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECG abnormalities are findings that are clinically meaningful by the judgment of the investigator. A 12-lead ECG was performed and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis.|||participants|||Number
1287116|NCT00162097|Secondary|Number of Participants With Urinalysis MAs|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following urinalysis MA definitions specify the criteria for MAs in the data presented. The presence of white blood cells (WBCs) and red blood cells (RBCs) in the urine was graded on a scale: 0 = no cells present (negative); trace =a small number of cells present; then 1+, 2+, 3+ and 4+, denoting increasingly “positive” urine results (ie, WBCs/RBCs present in the urine). The MA for both WBCs and RBCs was >= 2+ (or, if pre-treatment value >=2+, then >= 4+).|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 and were evaluated for these measures.|||participants|||Number
1287117|NCT00162097|Secondary|Number of Participants With Serum Chemistry MAs|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify the criteria for MAs in the data presented. High bilirubin (total): >1.1 x ULN (or if pre-treatment value >ULN, then >1.25 x pre-treatment value). High creatinine: >1.33 x pre-treatment value. Low albumin: <0.9 x LLN (or if pre-treatment value <LLN, then <0.9 x pre-treatment value). High amylase (total): >2 x pre-treatment value.|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 were included in the analysis. The 'n' signifies those participants who received study drug and were evaluated for this measure, for each group respectively.|||participants|||Number
1287118|NCT00162097|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Low platelet count: <0.85 x lower limit of normal (LLN) (or if pre-treatment value <LLN, then <0.85 x pre-treatment value). Low leukocytes: <0.9 x LLN (or if pre-treatment value <LLN, then <0.85 x pre-treatment value. If pre-treatment value >upper limit of normal [ULN], then <LLN). Low neutrophils+bands (absolute): <=1.500 10^3 cells/microliter (uL). Low lymphocytes (absolute): <0.750 10^3 cells/uL.|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 and were evaluated for these measures.|||participants|||Number
1287119|NCT00162097|Secondary|Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation|AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product. Participants who discontinued the study due to an AE were recorded.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).|All participants who received study drug on Day 1 were included in the analysis.|||participants|||Number
1287120|NCT00162097|Secondary|Number of Participants Who Experienced AEs|AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).|All participants who received study drug on Day 1 were included in the analysis.|||participants|||Number
1287230|NCT00159965|Secondary|Clinical Global Impressions - Severity (CGI-S)|"The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal (1) to among the most extremely ill patients (7). A higher score relates to a higher severity of illness."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
1287121|NCT00162097|Primary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])|The AUC(TAU), from time 0 to the time of the last measurable concentration (t), was calculated by the linear trapezoidal rule.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.|||mcg*h/mL||Full Range|Geometric Mean
1287122|NCT00162097|Primary|Minimum Plasma Concentration (Cmin)|Cmin was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.|||mcg/mL||Full Range|Geometric Mean
1287123|NCT00162097|Secondary|Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs)|An SAE was defined as any adverse event (AE) occurring at any dose that; resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge.|All data from participants who signed the informed consent and enrolled in the study is included in the data set used for evaluating SAEs.|||Participants|||Number
1287124|NCT00162097|Primary|Maximum Plasma Concentration (Cmax)|Cmax was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.|||micrograms (mcg)/mL||Full Range|Geometric Mean
1287125|NCT00162032|Secondary|In Addition, a Determination of the Safety of Sestamibi Will be Evaluated at the End of the Study Through Adverse and Serious Adverse Events Reported and Evaluating Vital Signs, ECGs, Physical Exams and Laboratory Tests for Each Subject.||3 year follow up|||||||
1287126|NCT00162032|Secondary|Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease.||3 year follow up|||||||
1287127|NCT00162032|Primary|Kawasaki Disease Population at High and Low Risk of Developing Cardiac Events Though Three Years Follow-up.|The proportion of all patients who experienced cardiac events among patients with abnormal (SSS >=4, high risk) and normal (SSS <4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.|3 years|Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event|||proportion of participants||95% Confidence Interval|Number
1287128|NCT00161616|Secondary|Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)|Patients categorized as Success or Failure of CCRE. Success defined as a fracture judged to be both clinically healed by clinical investigator, “healed” (see primary outcome), and radiographically united by independent, blinded radiology panel, “united.” Patients deemed “not healed” or “not united” were assessed as failures.|1 year|All patients randomized were analyzed.|||patients|||Number
1287129|NCT00161616|Primary|Number of Patients With Healed Fractures|Patients categorized by investigator as healed, not healed, no outcome (using pre-specified criteria). Healed: no tenderness at fracture site or pain with weight bearing, presence of bridging callus or disappearance of fracture lines, no hardware failure, no secondary intervention to promote fracture healing. Not healed: diagnosis of delayed union or nonunion, hardware failure, secondary intervention procedure for fracture healing recommended or performed, or conduct of procedure that may interfere with fracture healing. No outcome: subjects who did not achieve either healed or not healed.|13 and 20 weeks|All patients randomized were analyzed.|||patients|||Number
1287130|NCT00161473|Secondary|Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation|"The Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that rates psychiatric symptoms. Each item ranges from 1 to 7. Therefore, the Brief Psychiatric Rating Scale total score ranges from a minimum of 0 to a maximum of 126, where 126 indicates higher levels of behavioral symptoms.~A change Brief Psychiatric Rating Scale score that is a negative number (that is, a Brief Psychiatric Rating Scale score decrease), indicates behavioral improvement."|Weeks 2, 4, 6, and 8 (change from Baseline)|"Participants with at least one follow-up behavioral assessment visit were included in this analysis.~The mean group change was determined by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations."|||units on a scale||Standard Deviation|Mean
1287131|NCT00161473|Secondary|Number of Behavioral Assessment Visits Completed|This measure reflects the length of time participants remained in the study. There were 6 behavioral assessment visits included in the protocol.|Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)||||number of visits||Standard Deviation|Mean
1287132|NCT00161473|Primary|Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation|"The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms.~A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement."|Weeks 2, 4, 6, and 8 (change from Baseline)|"Participants with at least one follow-up behavioral assessment visit were included in this analysis.~The mean group change was calculated by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations."|||units on a scale||Standard Deviation|Mean
1287133|NCT00161473|Primary|Mean Clinical Global Impression of Change (CGIC) at Last Observation|"The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates markedly improved, 4 indicates no change, and 7 indicates markedly worse."|Week 8|Participants with at least one follow-up behavioral assessment visit were included in this analysis|||units on a scale||Standard Deviation|Mean
1287134|NCT00161382|Secondary|Proportion of Students That Are Sexually Active||Measured over a period of 30 days|||||||
1287135|NCT00161382|Secondary|Communication With Parents||Measured throughout the study|||||||
1287141|NCT00161382|Primary|Initiation of Sexual Intercourse|The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome. The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools. Sexual activity was defined as participation in vaginal, oral, or anal sex. Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.|Measured throughout the study, and at 2006/2007 school year||||participants|||Number
1287142|NCT00161213|Secondary|Overall Survival||5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.|||months||95% Confidence Interval|Median
1287143|NCT00161213|Secondary|1-year Survival Rate|Percentage of subjects who survive up to 1 year|5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.|||percentage of total evaluable subjects||95% Confidence Interval|Number
1287144|NCT00161213|Secondary|Response Rate|"Response rate as defined by a best response of Stable Disease or better."|5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response. Seven subjects were not assessed for response as they discontinued therapy treatment before response was assessed.|||percentage of total evaluable subjects||95% Confidence Interval|Number
1287145|NCT00161213|Primary|Progression-free Survival|Progression-free survival in months.|4 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.|||months||95% Confidence Interval|Median
1287146|NCT00160706|Secondary|Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256||Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 280 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||µg/g stool||95% Confidence Interval|Geometric Mean
1287147|NCT00160706|Secondary|C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit||Study Completion Visit (Week 362) / (Early) Withdrawal Visit|All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||mg/L||95% Confidence Interval|Geometric Mean
1287148|NCT00160706|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)|Of the 310 subjects in the Safety Population, 309 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
1287149|NCT00160706|Secondary|Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit|Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Study Completion Visit (Week 362) / (Early) Withdrawal Visit|Of the 310 subjects in the Safety Population, 307 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||µg/mL||95% Confidence Interval|Geometric Mean
1287150|NCT00160706|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 299 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
1287151|NCT00160706|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 307 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
1287231|NCT00159965|Secondary|Oxford Handicap Scale (OHS)|"The OHS is a brief clinician scored assessment of symptoms and lifestyle interference and the 6 grades of disability are based on the modified Rankin Scale, ranging from 0 (no symptoms) to 5 (severe handicap). A higher score relates to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
1287152|NCT00160706|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Study Completion Visit (Week 362) / (Early) Withdrawal Visit|All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
1287153|NCT00160706|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)|All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
1287154|NCT00160706|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)|All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
1287155|NCT00160693|Secondary|Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years|This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.|From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).|||percentage of subjects|||Number
1287156|NCT00160693|Secondary|Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years||From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).|||percentage of subjects|||Number
1287157|NCT00160693|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Of the 402 subjects in the Safety Set (SS), 400 subjects are included in this analysis, because they had available data at Baseline and Completion or early Withdrawal Visit.|||units on a scale||Standard Deviation|Mean
1287158|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).|||percentage of subjects||95% Confidence Interval|Number
1287159|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).|||percentage of subjects||95% Confidence Interval|Number
1287160|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).|||percentage of subjects||95% Confidence Interval|Number
1287169|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.|||units on a scale||Standard Deviation|Mean
1287161|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316|"The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 316|Of the 402 subjects in the Safety Set (SS), 140 subjects are included in this analysis, because they had available data at Baseline and Week 316.|||percentage of subjects||95% Confidence Interval|Number
1287162|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256|"The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 256|Of the 402 subjects in the Safety Set (SS), 211 subjects are included in this analysis, because they had available data at Baseline and Week 256.|||percentage of subjects||95% Confidence Interval|Number
1287163|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208|"The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 208|Of the 402 subjects in the Safety Set (SS), 223 subjects are included in this analysis, because they had available data at Baseline and Week 208.|||percentage of subjects||95% Confidence Interval|Number
1287164|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160|"The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 160|Of the 402 subjects in the Safety Set (SS), 247 subjects are included in this analysis, because they had available data at Baseline and Week 160.|||percentage of subjects||95% Confidence Interval|Number
1287165|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100|"The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 100|Of the 402 subjects in the Safety Set (SS), 275 subjects are included in this analysis, because they had available data at Baseline and Week 100.|||percentage of subjects||95% Confidence Interval|Number
1287166|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52|"The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 52|Of the 402 subjects in the Safety Set (SS), 370 subjects are included in this analysis, because they had available data at Baseline and Week 52.|||percentage of subjects||95% Confidence Interval|Number
1287167|NCT00160693|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms."|From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).|||percentage of subjects|||Number
1287168|NCT00160693|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP up to 8 years|Safety Set (SS).|||percentage of subjects|||Number
1287232|NCT00159965|Secondary|Symptom Checklist 90 (SCL-90)|"The SCL-90 is a 90 item self-report clinical rating scale oriented toward symptomatic behavior of outpatients, assessing from 0 (not at all bothered) to 4 (extremely bothered). The highest possible overall score is 360 and relates to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
1287170|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.|||units on a scale||Standard Deviation|Mean
1287171|NCT00160641|Secondary|Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit|Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.|||percentage of participants|||Number
1287172|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/ hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.|||units on a scale||Standard Deviation|Mean
1287173|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness|Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 563 are included in this analysis. Data not available for 4 subjects.|||hours||Standard Deviation|Mean
1287174|NCT00160641|Secondary|Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 560 are included in this analysis. Data not available for 7 subjects.|||units on a scale||Standard Deviation|Mean
1287175|NCT00160641|Secondary|Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Week 104 of the open-label study|Of the 567 subjects in the Safety Set (SS), 423 are included in this analysis. Data not available for 144 subjects.|||units on a scale||Standard Deviation|Mean
1287176|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal|The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.|||percentage of participants||95% Confidence Interval|Number
1287177|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244|The assessments are based on a 70 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.|||percentage of participants||95% Confidence Interval|Number
1287213|NCT00160251|Secondary|Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period|"All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.~The dosing interval of 8 hours is represented as the hr in the unit of measure."|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.|||ng*hr/mL||Standard Error|Mean
1287178|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196|The assessments are based on a 70 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.|||percentage of participants||95% Confidence Interval|Number
1287179|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148|The assessments are based on a 70 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.|||percentage of participants||95% Confidence Interval|Number
1287180|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100|The assessments are based on a 70 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.|||percentage of participants||95% Confidence Interval|Number
1287181|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52|The assessments are based on a 70 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.|||percentage of participants||95% Confidence Interval|Number
1287182|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal|The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.|||percentage of participants||95% Confidence Interval|Number
1287183|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244|The assessments are based on a 50 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.|||percentage of participants||95% Confidence Interval|Number
1287184|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196|The assessments are based on a 50 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.|||percentage of participants||95% Confidence Interval|Number
1287214|NCT00160251|Secondary|Peak Plasma Concentration of Boceprevir (BOC)|All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.|||ng/mL||Standard Error|Mean
1287185|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148|The assessments are based on a 50 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.|||percentage of participants||95% Confidence Interval|Number
1287186|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100|The assessments are based on a 50 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.|||percentage of participants||95% Confidence Interval|Number
1287187|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52|The assessments are based on a 50 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.|||percentage of participants||95% Confidence Interval|Number
1287188|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal|The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.|||percentage of participants||95% Confidence Interval|Number
1287189|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244|The assessments are based on a 20 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.|||percentage of participants||95% Confidence Interval|Number
1287190|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196|The assessments are based on a 20 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.|||percentage of participants||95% Confidence Interval|Number
1287191|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148|The assessments are based on a 20 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.|||percentage of participants||95% Confidence Interval|Number
1287215|NCT00160251|Secondary|Percent of Participants With Virologic Response Prior to Amendment 2|Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.|Week 3, Week 5, Week 13||||Percent of participants|||Number
1288263|NCT00144339|Secondary|Number of Exacerbation Leading to Hospitalization|Estimated number of exacerbations leading to hospitalizations per patient year|From Day 1 to 4 years||||Number per patient year|||Number
1287192|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100|The assessments are based on a 20 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.|||percentage of participants||95% Confidence Interval|Number
1287193|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52|The assessments are based on a 20 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.|||percentage of participants||95% Confidence Interval|Number
1287194|NCT00160641|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device.~The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms."|From Entry Visit (Week 0) to the end of the study (approximately 6.3 years)|Safety Set|||percentage of participants|||Number
1287195|NCT00160641|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years|"A SAE is any untoward medical occurrence that at any dose:~Results in death~Is life-threatening~Requires in patient hospitalisation or prolongation of existing hospitalisation~Results in persistent or significant disability/incapacity, or~Is a congenital anomaly or birth defect~Is as infection that requires treatment parenteral antibiotics~Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above~First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 6.8 years)|Safety Set|||percentage of participants|||Number
1287196|NCT00160641|Primary|Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years|An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.|From first dose of CZP to the end of the open-label study (approximately 6.8 years)|Safety Set|||percentage of participants|||Number
1287197|NCT00160563|Secondary|Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.||18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)|Analysis was not performed due to premature discontinuation of the study.||||||
1287198|NCT00160563|Primary|Time to Onset of Asthma||36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)|Analysis was not performed due to premature discontinuation of the study.||||||
1287199|NCT00160524|Secondary|Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258||Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 567 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||μg/g stool||95% Confidence Interval|Geometric Mean
1287200|NCT00160524|Secondary|C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit||Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 593 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||mg/L||95% Confidence Interval|Geometric Mean
1287201|NCT00160524|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)|Of the 595 subjects in the Safety Population, 593 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
1287202|NCT00160524|Secondary|Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit|Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 595 subjects in the Safety Population, 590 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||μg/mL||95% Confidence Interval|Geometric Mean
1288264|NCT00144339|Secondary|Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization||From Day 1 to 4 years||||Participants|||Number
1287203|NCT00160524|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being. The first three parameters are scored for the previous day.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit|All 594 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
1287204|NCT00160524|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 592 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
1287205|NCT00160524|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)|All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
1287206|NCT00160524|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)|All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
1287207|NCT00160251|Primary|Percent of Participants Who Achieved Sustained Virologic Response (SVR)|"SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.~All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.~For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.~Arm 1A was not analyzed."|Baseline up to Week 73 [24 weeks after end of treatment (EoT)]|For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.|||Percent of participants|||Number
1287208|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73) (up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.|||Participants|||Number
1287209|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73)(up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.|||Participants|||Number
1287210|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73)(up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.|||Participants|||Number
1287211|NCT00160251|Secondary|Change in Alanine Aminotransferase (ALT) Levels|Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.|Baseline up to dosing change (> 25 weeks)|Only participants with at least one value for the laboratory test were included.|||Participants|||Number
1287212|NCT00160251|Secondary|Trough Plasma Concentration Level|All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.|||ng/mL||Standard Error|Mean
1287229|NCT00159965|Secondary|Clinical Global Impressions - Improvement (CGI-I)|"The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved (1) to very much worse (7). A lower score represents a higher improvement."|Weeks 2, 6, 10||||Units on a scale||Standard Deviation|Mean
1287216|NCT00160251|Secondary|Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop|"For each log drop category (<0, 0 to 0.5, 0.5 to <1, 1 to <1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:~Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).~Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group."|Week 1 and Week 49|N=Number of Participants Analyzed, n=number of participants in each log category group. The PEG + BOC 100, 200, or 400 arm combined the following treatment arms: Arm 2 PEG + BOC 100 (48 weeks), Arm 3 PEG + BOC 200 (48 weeks), Arm 4 PEG + BOC 400 (48 weeks), Arm 6 PEG + BOC 400 (24 weeks).|||Percent of participants|||Number
1287217|NCT00160251|Secondary|Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA|Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.|Baseline up to Week 73 [24 weeks after EoT]|Number of participants across all treatment arms who achieved negative HCV-RNA|||Percent of participants|||Number
1287218|NCT00160251|Primary|Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)|"Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.~All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.~For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.~Arm 1A was not analyzed."|Baseline up to Week 49|For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.|||Percent of participants|||Number
1287219|NCT00160199|Secondary|Time to Withdrawal Bleeding After Second Treatment Cycle|The number of days between the second cycle of treatment and the withdrawal bleeding|End of the second cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||Days||Standard Deviation|Mean
1287220|NCT00160199|Secondary|Time to Withdrawal Bleeding After First Treatment Cycle|The number of days between the first cycle of treatment and the withdrawal bleeding.|End of the first cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||Days||Standard Deviation|Mean
1287221|NCT00160199|Secondary|The Duration of Withdrawal Bleeding After Second Treatment Cycle|The numbers of days the subjects actually bled after the end of the second treatment cycle|End of the second cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||Days||Standard Deviation|Mean
1287222|NCT00160199|Secondary|The Duration of Withdrawal Bleeding After the First Treatment Cycle|The numbers of days the subjects actually bled after the end of the first treatment cycle.|End of the first cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||Days||Standard Deviation|Mean
1287223|NCT00160199|Secondary|Maximum Intensity of Withdrawal Bleeding After Any Cycle|The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy|Duration of withdrawal bleed|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||participants|||Number
1287224|NCT00160199|Primary|Number of Subjects With Withdrawal Bleeding|This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.|After first and second cycle (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||participants|||Number
1287225|NCT00160199|Primary|Secretory Conversion of the Endometrium|Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.|End of the study (Days 85)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||participants|||Number
1287226|NCT00159965|Secondary|Quality of Life in Epilepsy-31 (QOLIE-31)|This is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
1287227|NCT00159965|Secondary|Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|"The LIFE-RIFT interview is a brief semi-structured interview, which measures functional impairment, targeting four domains: work, interpersonal relations, recreation and global satisfaction. Work, recreation and global satisfaction are rated on a 1 (very good/ no impairment) to 5 (very poor/ severe impairment) scale, and interpersonal relations is rated on a 1 (very good) to 7 (variable) scale. The highest score possible is 20 and relates to a more severe impairment. The lowest possible score is 3."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
1287228|NCT00159965|Secondary|Family Assessment Device (FAD)|"The FAD is a 60 item self-report questionnaire designed to assess the six dimensions of the McMaster Model of Family Functioning, as well as overall level of family functioning through the General Functioning Scale. Each question is scored on a 1 to 4 scale, with a higher mean score relating to a worse general functioning."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||General Functioning Subscale Score||Standard Deviation|Mean
1288265|NCT00144339|Secondary|Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)||Day 1 to 4 years||||months||95% Confidence Interval|Median
1287233|NCT00159965|Secondary|Dissociative Experiences Scale (DES)|The DES is a 28 item self-report questionnaire designed to quantify dissociative experiences which identifies disturbances in memory, identity, cognition, derealization, depersonalization, absorption and imagination. A visual analogue scale is used ranging from 0% (“This never happens to you”) to 100% (“This always happens to you”). The score is divided by 28 items to yield a range of 0 to 100%, with a higher score relating to a higher degree of dissociation.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||units on a scale||Standard Deviation|Mean
1287234|NCT00159965|Secondary|Barratt Impulsivity Scale (BIS)|"The BIS is a 30 item self-report measure that characterizes four aspects of impulsiveness, and ranges from rarely/ never to almost always with a score of 1 to 4 possible on each question, giving a maximum possible score of 120 and minimum possible score of 30. Selected questions are reversed scored. Higher scores relate to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
1287235|NCT00159965|Secondary|Davidson Trauma Scale (DTS)|The DTS is a 17-item self-report scale measuring each Diagnostic and Stastical Manual of Mental Disorders-4th Edition (DSM-IV) symptom of post-traumatic stress disorder (PTSD) on 5-point frequency (0-not at all to 4-everyday) and severity (0-not at all distressing to 4-extremely distressing) scales. The highest possible score is 136 and relates to the worst outcome.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||units on a scale||Standard Deviation|Mean
1287236|NCT00159965|Secondary|Global Assessment of Functioning (GAF)|This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning of a subject during a specified time period on a continuum from psychological or psychiatric sickness to health.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
1287237|NCT00159965|Secondary|Modified Hamilton Depression Scale (MHRS)|"The MHRS assesses the severity of Depression-related symptoms from 0 (not present) to 2, 3 or 4 (severe) on each question. The highest possible score is 72, relating to the worst outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||units on a scale||Standard Deviation|Mean
1287238|NCT00159965|Secondary|Beck Depression Inventory-II (BDI-II)|"The BDI-II assesses depression severity from 0 (no Depression-related symptom) to 3 (severe) on each question. The highest possible score is 51, relating to the worst outcome."|bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12||||Units on a scale||Standard Deviation|Mean
1287239|NCT00159965|Primary|Number of Nonepileptic Seizures (NES)|psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.|bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12||||seizures||Standard Deviation|Median
1287240|NCT00159913|Primary|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population|Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = [(week 16 value minus baseline mean)/mean at baseline]*100%.|Baseline, Week 16|Per Protocol Population|||percent change||Standard Deviation|Mean
1287241|NCT00159913|Secondary|Change From Baseline to Week 16 in World Health Organization (WHO) Pulmonary Hypertension (PH) Functional Class|WHO PH functional class definitions adapted from New York Heart Association Criteria for Functional Capacity and Therapeutic Class Definitions. Class I = PH without resulting limitation of physical activity, Class II = PH resulting in slight limitation of physical activity, Class III = PH resulting in marked limitation of physical activity, Class IV = PH with inability to carry out any physical activity without symptoms. Improved by 1 class = Class 4 to 3, Class 3 to 2, Class 2 to 1. Improved by 2 classes = Class 4 to 2, Class 3 to 1. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, LOCF|||units|||Number
1287242|NCT00159913|Secondary|Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Psychosocial Scales|CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects >= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social & school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, includes subjects >= 5years with a valid questionnaire available in the subject's first language.|||score on scale||Standard Deviation|Mean
1287243|NCT00159913|Secondary|Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Physical Scale|CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects >= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social & school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, includes subjects >= 5 years with a valid questionnaire available in the subject's first language.|||score on scale||Standard Deviation|Mean
1287244|NCT00159913|Secondary|Change From Baseline to Week 16 in Right Atrial Pressure (RAP)|RAP was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for missing data.|||mm Hg||Standard Deviation|Mean
1287245|NCT00159913|Secondary|Change From Baseline to Week 16 in Cardiac Index (CI)|CI is observed value at Week 16 minus Baseline value. Calculated as cardiac output in systemic circulation (COsys) / body surface area (BSA).|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for handling missing data.|||liters/minute/meters squared||Standard Deviation|Mean
1287246|NCT00159913|Secondary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)|Change calculated as (mean PAP - PCWP)/COpulm in PVR is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for handling missing data|||wood units||Standard Deviation|Mean
1287247|NCT00159913|Secondary|Percent Change From Baseline to Week 16 in Time to Maximum Volume of Oxygen Consumed (VO2)|Time to maximum VO2 was assessed on the subset of subjects who are developmentally able to perform the exercise test. Percent change is [(value at Week 16 minus Baseline value)/Baseline value] * 100%|Baseline, Week 16|ITT population, LOCF (end-of-treatment) approach for handling missing values.|||percent change||Standard Deviation|Mean
1288266|NCT00144339|Secondary|Number of Exacerbation Days Per Patient Year|Number of exacerbation days normalized by treatment exposure|Day 1 to 4 years||||days/patient year||Standard Error|Mean
1287248|NCT00159913|Secondary|Percent Change From Baseline to Week 16 in: Respiratory Exchange Ratio (RER)|RER is the ratio of carbon dioxide produced to oxygen consumed [VCO2/VO2]). Percent change is [(Week 16 value minus Baseline value)/Baseline value] * 100%|Baseline, Week 16|ITT population, LOCF (end-of-treatment) approach for handling missing values.|||percent change||Standard Deviation|Mean
1287249|NCT00159913|Secondary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance Index (PVRI)|PVRI equals Pulmonary Vascular Resistance (PVR) times Body Surface Area (BSA). Wood unit = 80dyn•s/cm5. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, LOCF|||wood units. m2||Standard Deviation|Mean
1287250|NCT00159913|Secondary|Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP)|mPAP, a hemodynamic parameter, was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using a LOCF (end-of-treatment) approach for handling missing data.|||mm Hg||Standard Deviation|Mean
1287251|NCT00159913|Primary|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population|Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = [(week 16 value minus baseline mean)/mean at baseline]*100%.|Baseline, Week 16|ITT population included all subjects randomised and who received at least one dose of study medication. All subjects developmentally able to perform the exercise test. Subjects assumed developmentally able if they had a CPX exercise assessment at any visit during study using a LOCF (end-of-treatment)approach for handling missing data.|||percent change||Standard Deviation|Mean
1287252|NCT00159874|Secondary|Physician Global Assessment at Year 1|The physician global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants with markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments.|Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
1287253|NCT00159874|Secondary|Participant (Parent) Global Assessment at Year 1|The participant (parent) global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments.|Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
1287254|NCT00159874|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at Year 1.|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Year 1|ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included.|||Units on a scale||Standard Deviation|Mean
1287255|NCT00159874|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Psychosocial Scale at Year 1.|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Year 1|ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included.|||Units on a scale||Standard Deviation|Mean
1287256|NCT00159874|Secondary|Additions From Baseline in Background Therapy up to the End of Study|This was defined as an addition or discontinuation in the class(es) of drugs used as background medication (e.g., anticoagulants, oxygen, diuretics, calcium channel blockers, and digoxin) compared to baseline of Study A1481131 (NCT00159913).|Up to the end of study|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
1287257|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 4.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 4|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
1287258|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 3.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 (NCT00159913) baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 3|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
1287259|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 2.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 2|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
1287260|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in World Health Organization Pulmonary Hypertension (WHO PH) Functional Class by A1481156 Treatment Group at Year 1.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarized at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
1287261|NCT00159874|Secondary|Percentage Change From Baseline in Anaerobic Threshold at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the anaerobic threshold at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
1287262|NCT00159874|Secondary|Percentage Change From Baseline in End Tidal Carbon Dioxide (CO2) at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal CO2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
1287263|NCT00159874|Secondary|Percentage Change From Baseline in End Tidal Oxygen (O2) at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal O2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
1287493|NCT00154297|Secondary|Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period|A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed.|Month 12|Intention to treat (ITT) population.|||Participants|||Number
1287264|NCT00159874|Secondary|Percent Change From Start of Sildenafil in Total Ventilation (VE) to Year 1|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the total ventilation. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
1287265|NCT00159874|Secondary|Percent Change From Baseline in Respiratory Exchange Ratio at Year 1|This is the ratio of carbon dioxide (CO2) produced to O2 consumed [VCO2/VO2]. Exercise Tolerance Test was performed on developmentally able participants to determine the respiratory exchange ratio on week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913).|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
1287266|NCT00159874|Secondary|Percent Change From Baseline in Time to Maximum VO2 at Year 1|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the time to maximum VO2. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
1287267|NCT00159874|Secondary|Percentage Change From Baseline in Percent Predicted Peak VO2 at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the percent predicted peak VO2 at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
1287268|NCT00159874|Secondary|Peak Volume of Oxygen (VO2) Consumed at Year 1 Using a Bicycle Ergometry Cardiopulmonary Exercise Test (CPX)|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the peak volume of VO2 consumed. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant|1 year|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||mL/kg/min||Standard Deviation|Mean
1287269|NCT00159874|Primary|Pediatric Motor Development Status at Week 52|Participant's motor development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 52|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.|||Participants|||Number
1287270|NCT00159874|Primary|Pediatric Motor Development Status at Week 16.|Participant's motor development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 16|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.|||Participants|||Number
1287271|NCT00159874|Primary|Pediatric Cognitive Development Status at Week 52.|Participant's cognitive development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 52|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.|||Participants|||Number
1287272|NCT00159874|Primary|Pediatric Cognitive Development Status at Week 16.|Participant's cognitive development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 16|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.|||Participants|||Number
1287273|NCT00159874|Primary|Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests.|Colour vision was measured where appropriate via the Farnsworth-Munsell D-15 Hue test. This test was performed in both eyes simultaneously or just in a single specific eye. If using a single eye the same eye was used throughout the study. In case of young participants an age-and-ability-appropriate evaluation such as the Ishihara Test for Unlettered Persons were conducted.|Week 36|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).|||Participants|||Number
1287274|NCT00159874|Primary|Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests|Visual Acuity is measured either using the reduced Snellen test or via Teller cards, and was assessed in the left and right eyes separately. There were 9 lines on the reduced Snellen chart which were coded as 6/60, 6/36, 6/24, 6/18, 6/12, 6/9, 6/6, 6/5, 6/4 (where 6/60 was the easiest to read and 6/4 was the most difficult to read). If a participant experienced a visual adverse event the investigator was asked to perform additional ocular assessments either at the visit when the participant reported the visual adverse event or at an unplanned visit.|Week 36|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).|||Participants|||Number
1287275|NCT00159874|Primary|Downtitration in Dose Due to Intolerability.|Based on review of the survival data, DMC concluded that the high dose of sildenafil was associated with a harmful effect on survival when compared to the low dose. The DMC also expressed concern as to the potential dose-response relationship between increasing dose and mortality. Therefore, on 04 August 2011, the DMC recommended discontinuation of the 40 mg and 80 mg three times a day (TID) doses, as well as the 20 mg TID dose in children with body weight ≤20 kg. The protocol was amended per DMC recommendations.|Pre-DMC recomendation (04 August 2011)|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).|||Participants|||Number
1287276|NCT00159874|Primary|Discontinuation Due to Intolerability|Participant who experienced drug-related intolerance, the participant’s dose was reduced by 50%. If, after a dose reduction, the participant continued to appear intolerant, they were discontinued from study treatment.|Throughout the treatment duration (median treatment duration 1689 to 1744 days)|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).|||Participants|||Number
1287277|NCT00159874|Primary|Number of Deaths Reported During This Study|Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later.|Last follow-up visit or 30 days after the last administration of study drug|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
1287278|NCT00159874|Primary|Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration|Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later.|Pre-DMC Recommendation dose down titration (04 August 2011)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
1287279|NCT00159874|Primary|Number of Participants Reporting Treatment-related Serious Adverse Events|All serious adverse events regardless of treatment group or suspected relationship to study drug were reported. Investigators were to provide independent determination of possible causality of any serious adverse event.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
1287280|NCT00159874|Primary|Number of Participants Reporting at Least One Serious Adverse Event|Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the serious adverse events according to the A1481156 treatment groups are provided in the reported adverse event section.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
1287281|NCT00159874|Primary|Number of Participants Reporting Treatment-related Adverse Events|Safety was measured according to standard adverse event collection as described in the adverse event section of the results.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
1287282|NCT00159874|Primary|Number of Participants Reporting at Least One Adverse Event|Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the adverse events according to the A1481156 treatment groups are provided in the reported adverse event section.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
1287328|NCT00158756|Secondary|Concentrations of Anti-T Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1287283|NCT00159861|Secondary|Change From Baseline in BORG Dyspnea Score|BORG Dyspnea score: change from core study Baseline. Subject rating of maximum degree of dyspnea experienced at any time during the 6-Minute Walk Test. Range: 0 (no breathlessness at all) to 10 (maximum breathlessness).|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who were only treated in the core study and those who continued into the extension study.|||scores on scale||Full Range|Median
1287284|NCT00159861|Secondary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score|Subject-rated measure of health status (36 items): 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, mental health), 2 summary scores (physical component, mental component), and a self-evaluated change in health status. Change from Baseline in SF-36 Health Transition score at each visit. I=much better than 1 year ago; II=somewhat better than 1 year ago; III=about the same as 1 year ago; IV=somewhat worse than 1 year ago; V=much worse than 1 year ago|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those continued into the extension study. BL=Baseline.|||participants|||Number
1287285|NCT00159861|Secondary|Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those continued into the extension study.|||scores on scale||95% Confidence Interval|Mean
1287286|NCT00159861|Secondary|Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those who continued into the extension study.|||scores on scale||95% Confidence Interval|Mean
1287287|NCT00159861|Secondary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with SF-36 score at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those who continued into the extension study. Phys = physical.|||scores on scale||95% Confidence Interval|Mean
1287288|NCT00159861|Secondary|Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class|Pulmonary hypertension (PH) criteria: Class I: PH without limitation of physical activity (PA) (no undue dyspnea, fatigue, chest pain, near syncope); Class II: PH with slight limitation in PA, comfortable at rest, ordinary PA causes undue dyspnea, fatigue, chest pain, near syncope; Class III: PH with marked limitation in PA, comfortable at rest, less than ordinary activity causes undue dyspnea, fatigue, chest pain or syncope; Class IV: PH with inability to carry out PA without symptoms, signs of right heart failure, dyspnea or fatigue may be present at rest, discomfort increased by any PA.|1 Year, 2 Year, 3 Year|FAS; N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects in core study and in extension study. Scores for categorized changes for missing visits imputed as worse score of its non-missing neighbors; missing visits with no subsequent score: score coded to missing.|||participants|||Number
1287289|NCT00159861|Primary|Categorized Change From Baseline in 6-Minute Walking Distance|Number of subjects with categorized change in 6-minute walking distance. Distance that a subject could walk in 6-minutes at a comfortable pace with as many breaks as needed. Performed as close to trough levels of sildenafil as possible (just before dosing; at least 4 hours after the previous dose of study drug). Scores for categorized changes for missing visits were imputed as the worse score of its non-missing neighbors. If a visit was missing and there was no subsequent score, the score was coded to missing.|1 Year, 2 Year, 3 Year|FAS. m = meters. N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects who were only treated in the core study and those who continued into the extension study.|||participants|||Number
1287290|NCT00159861|Secondary|Survival Status|Yearly survival status: number of subjects who survived, discontinued, and died. Analysis includes post-treatment visit data from subjects who discontinued study treatment. Time to death was taken relative to the first dose of study treatment in A1481141, and was censored on the last day the subject was known to be alive in A1481141 or A1481153.|1, 2, 3, 4, and 5 years|Full analysis set: all randomized and treated subjects recruited into core study. N=number of subjects with evaluable data at core study Baseline.|||participants|||Number
1288267|NCT00144339|Secondary|Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation||Day 1 to 4 years||||Participants|||Number
1287291|NCT00159861|Other Pre-specified|Change in Epoprostenol Dose From Baseline Maintained for 6 Months|Number of subjects with changes in Epoprostenol dose from baseline maintained continuously for 6 months. Increased = Epoprostenol dose continuously more than 20% greater than core study Baseline for at least 6 months. Decrease = Epoprostenol dose continuously more than 20% less than core study Baseline for at least 6 months. No change = Epoprostenol dose change met neither Increase or Decrease criteria. Stopped = Epoprostenol dose stopped for at least 6 months.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, and at 3-month intervals through Month 69|Safety population: all subjects who took at least one dose of study medication in core study. N=number of subjects with evaluable data at core study Baseline. Includes subjects who were only treated in the core study and those who continued into the extension study.|||participants|||Number
1287292|NCT00159822|Secondary|Number of Subjects With Complete or Partial Serological Response|Serological response: normalization (complete response) defined as return to normal values (≤ 1 arc); partial response defined as significant decrease but not complete (decrease of 2 or more arcs compared to baseline). Complete or partial response summarized as Improvement; based on arc values at visit compared to arc values at baseline (inclusion).|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT (with serology at inclusion); 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available. Data summarized as Worsening (failure), No change (stabilization), or Improvement (complete or partial response) due to large number of missing results values.|||participants|||Number
1287293|NCT00159822|Secondary|Number of Subjects With Mycological Response of Eradication|Mycological response: eradication: absence of aspergillus species (spp) in bronchopulmonary samples: sputum, bronchial aspirate or bronchoalveolar lavage (BAL) (negative direct examination [exam] and negative culture), and negative histological exam when available; persistence (no eradication): presence of aspergillus spp in any relevant bronchopulmonary samples. Not done (presumed eradication): case reviewed by DRC for any mycological exams not performed to assess if case should constitute presumed eradication (no sputum due to clinical improvement).|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available.|||participants|||Number
1287294|NCT00159822|Secondary|Number of Subjects With Complete or Partial Radiological Response|Radiological response: based on chest TDM except for tracheo-bronchialaspergillosis which was assessed by bronchoscopy. Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT; End of treatment (EOT) or at last visit available [LVA](EOT or LVA includes data from 6, 9 or 12 months in case of extension of the treatment period beyond 6 months).|||participants|||Number
1287295|NCT00159822|Secondary|Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire|Subject administered questionnaire to measure improvement in QOL; 50 questions exploring 3 different areas: symptoms, impact on activity profile (activity), and impact on daily life (impacts). Each item in an area is weighted based on empirical data; scores range from lowest possible weight 0 to highest possible weight 100. Scores for each section and total score calculated using score calculation algorithms with higher scores indicating poor health. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).|Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and EOS (EOT + 6 months)|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available; (n) = number of subjects with analyzable data at observation.|||scores on scale||95% Confidence Interval|Mean
1287296|NCT00159822|Secondary|Global Survival: Number of Subjects With an Outcome of Death|Number of subjects with an outcome of death (adverse event with a fatal outcome) through end of study.|Baseline through EOS (EOT + 6 months)|Safety population (SAF): all subjects who took at least 1 dose of voriconazole.|||participants|||Number
1287297|NCT00159822|Secondary|Time to Relapse After EOT|Time (months) to relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).|During the 6 months following EOT (EOT + 3 months, EOT + 6 months)|mITT; due to the small number of radiological reappearance (4 subjects), no formal analysis of this endpoint was performed.|||months|||Number
1287298|NCT00159822|Secondary|Number of Subjects With Relapse|Relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).|During the 6 months following EOT (EOT + 3 months, EOT + 6 months)|mITT; due to the small number of radiological reappearance (4 subjects), no formal analysis of this endpoint was performed.|||participants|||Number
1287299|NCT00159822|Secondary|Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS)|Subject assessment of improvement of respiratory clinical signs and symptoms as indicated by the subject placing a mark on a 10 cm VAS scored 0 (better state of health) to 100 (poor state of health) for cough, dyspnea, sputum, hemoptysis, chest tightness, and nocturnal awakening. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).|Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and End of study ([EOS] EOT + 6 months)|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available; (n) = number of subjects with analyzable data at observation. Subject may be represented in >1 category.|||scores on scale||95% Confidence Interval|Mean
1287300|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|mITT|||paticipants|||Number
1287301|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|mITT|||participants|||Number
1287302|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete (resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline) or partial (reduction in diameter ≥ 50 percent on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion) radiological response and mycological eradication after 3 months of treatment and after 9 or 12 months (in case of extension of treatment period beyond 6 months); no success=criteria not met. Assessment determined by DRC.|Month 3 and End of Treatment (Month 9 or Month 12)|mITT; End of treatment (EOT) or at last visit available [LVA] (EOT or LVA includes data from 6, 9 or 12 months in case of extension of the treatment period beyond 6 months). Month 6 analysis is reported in the primary outcome measure.|||participants|||Number
1287303|NCT00159822|Primary|Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50 percent on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|Modified Intent to Treat (mITT): all subjects in ITT population (took at least 1 dose of voriconazole and had at least 1 post-inclusion efficacy assessment) who had diagnosis of chronic bronchopulmonary aspergillosis confirmed by the Data Review Committee (DRC); 5 subjects excluded from mITT population due to unproven diagnosis.|||participants|||Number
1287304|NCT00159783|Primary|Number of Participants With Laboratory Values Outside Normal Range|"Normal ranges were provided by the central laboratory.~Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin~Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin~Endocrinology/miscellaneous = insulin, prolactin~Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils"|Week 40 or endpoint|"Number at risk = participants with either normal or abnormal baseline value and a non-missing value at endpoint.~Actual at risk: 20-32 for placebo/asenapine arm; 50-78 for asenapine arm; 63-106 in olanzapine arm."|||Participants|||Number
1287305|NCT00159783|Primary|Number of Participants With Markedly Abnormal Vital Sign Changes|"Vital signs measured: sitting blood pressure, heart rate.~Definitions:~Markedly abnormal decreases: heart rate (HR) – if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) – if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) – if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.~Markedly abnormal increases: HR – if ≥110 bpm and increase from baseline of ≥15 bpm; SBP – if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP – if ≥105 mm Hg and increase from baseline of ≥15 mm Hg."|Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)||||Participants|||Number
1287306|NCT00159783|Primary|Abdominal Girth|Change in abdominal girth from baseline|Baseline to Week 40 or endpoint||||Centimeters (cm)||Standard Deviation|Mean
1287307|NCT00159783|Primary|Concomitant Medications|"Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of~last dose of double-blind study drug."|Up to 40 weeks||||Participants|||Number
1287308|NCT00159783|Primary|Extrapyramidal Symptoms [EPS]|"EPS was assessed using the (1) involuntary movement scale [AIMS], (2) Barnes Akathisia Rating Scale [BARS], and (3) Simpson Angus Rating Scale SARS.~AIMS score range 0-4; higher scores indicate greater symptom severity.~BARS score rang 0-9; higher scores indicate greater severity of akathisia.~SARS score range 0-40; higher scores indicate greater degree of Parkinsonism."|Week 40 or endpoint||||Units on a scale||Standard Deviation|Mean
1287309|NCT00159783|Primary|Body Weight|Weight change from baseline|Baseline to Week 40 or endpoint||||Kilograms||Standard Deviation|Mean
1287310|NCT00159783|Primary|Number of Participants With Abnormal Electrocardiogram|This is the number of participants with electrocardiogram (ECG) adverse events.|Week 40 or endpoint||||Participants|||Number
1287311|NCT00159783|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm & rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.|Week 40 or endpoint||||Participants|||Number
1287312|NCT00159783|Primary|Participants Who Experienced Adverse Event(s)|"Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug.~An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment.~An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect."|Up to 40 weeks||||Participants|||Number
1287313|NCT00159432|Secondary|Number of Participants With Grade 3 or Higher Toxicity|Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.|Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months.|All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.|||Participants|||Number
1288268|NCT00144339|Secondary|Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year||Day 1 to 4 years||||number per patient year||Standard Error|Mean
1287314|NCT00159432|Primary|Median Time for Progression Free Survival|Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.|Up to 6 years|All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.|||Months||95% Confidence Interval|Median
1287315|NCT00159419|Primary|Bone Mineral Density|"By Dual-energy x-ray absorptiometry. Results were reported as z-scores as well as as absolute values. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome, or similar, as accurate and appropriate."|2 years||||z-score||Standard Deviation|Mean
1287316|NCT00158925|Secondary|Lead Implant Time|The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.|Implant|Although 96 subjects were implanted/attempted, lead implant time was only collected for 69 subjects.|||h.min||Standard Deviation|Mean
1287317|NCT00158925|Primary|Lead-related Complication-free Rate at 3 Months|The estimated target value for this endpoint is 80%.|3 months||||% of complication free-rate||95% Confidence Interval|Mean
1287318|NCT00158925|Primary|Chronic Sensing Amplitudes at 3 Months|The expected mean is 10mV.|3 months|Although 96 subjects were implanted/attempted, for 67 subjects still in follow up at the end of the 3M fu period, chronic sensing amplitude was measured.|||mV||Standard Deviation|Mean
1287319|NCT00158925|Primary|Chronic Pacing Impedances at 3 Months|The expected mean impedance is 500 Ohms.|3 months|Although 96 subjects were implanted/attempted, for 80 subjects still in follow up at the end of the 3M fu period, the mean impedance was measured.|||Ohms||Standard Deviation|Mean
1287320|NCT00158925|Primary|Chronic Pacing Thresholds at 3 Months|The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.|3 months|Although 96 subjects were implanted/attempted, for 80 subjects still in follow up at the end of the 3M fu periodm the mean pacing threshold was obtained.|||V||Standard Deviation|Mean
1287321|NCT00158756|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 4|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
1287322|NCT00158756|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"Number of subjects with any unsolicited adverse events (AEs)~An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|During the 31-day (Days 0-30) follow-up period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
1287323|NCT00158756|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were diarrhea, drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability, loss of appetite [loss of appet.] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.|During the 8-day period (Days 0-7) post-vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
1287324|NCT00158756|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).|During the 8-Day (Days 0-7) follow-up period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
1287325|NCT00158756|Secondary|Anti-Polio Type 1, 2, 3 Antibody Titers|Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1287326|NCT00158756|Secondary|Concentrations of Anti-RV Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.|At 2.5 months post dose 2 of Rotarix [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.lysis|||U/mL||95% Confidence Interval|Geometric Mean
1287327|NCT00158756|Secondary|Concentrations of Anti-BPT Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1287329|NCT00158756|Secondary|Concentrations of Anti-DT Antibodies|Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1287330|NCT00158756|Secondary|Concentrations of Anti-HBs Antibodies|Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1287331|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)|A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1287332|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen|A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1287333|NCT00158756|Secondary|Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values|A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).|At 2.5 months after dose 2 of Rotarix [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1287334|NCT00158756|Secondary|Number of Subjects With Vaccine Response to BPT Antigen|Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1287335|NCT00158756|Secondary|Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values|A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1287336|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies|A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).|At one most post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1287337|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA|A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
1287338|NCT00158756|Primary|Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies|Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.|At one month post dose 3 [PIII(M4)]|The analysis were performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1287339|NCT00158743|Primary|Change in Creatinine Clearance|change from baseline in creatinine clearance measured at 24 to 48 hours, comparing patients who received placebo with those who received digoxin immune fab|Baseline to 24-48 hours.||||milliliters/minute||Standard Deviation|Mean
1287340|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax)|Time to maximum plasma concentration observed in blood samples taken at the following time points: 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12, 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.|||hours||Standard Deviation|Mean
1287341|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax)|Maximum plasma concentration observed in blood samples taken at the following time points: 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12, 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.|||ng/mL||Standard Deviation|Mean
1287342|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC)|Area under the plasma concentration versus time curve from time zero (pre-dose) to 16 hours after the end of infusion. Blood sample time points were 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12 and 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.|||ug*h/mL||Standard Deviation|Mean
1287343|NCT00158600|Secondary|Health-related Quality of Life Survey Values Related to Physical Components as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Scores (PCS) report the four domains of physical functioning, role-physical, bodily pain, and general health. Higher scores are associated with better quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The PCS scores are reported.|weeks 0, 78|ITT population. Last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1287344|NCT00158600|Secondary|Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and is an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|weeks 0, 78|ITT population. Last observation carried forward.|||percent predicted QMT||Standard Deviation|Mean
1287345|NCT00158600|Primary|Percent of Predicted Forced Vital Capacity (FVC)|Forced vital capacity is a standard pulmonary function test used to quantify respiratory muscle weakness. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|weeks 0, 78|ITT population. Last observation carried forward.|||percent predicted FVC||Standard Deviation|Mean
1287346|NCT00158600|Primary|Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline|Mean distance walked gives an indication of functional endurance. The greater the distance, the greater the endurance. Mean values of distance walked in a six-minute walk test are offered for baseline, week 78 (or last available observation), and the mean change from baseline (at week 78 or last available post-baseline observation).|weeks 0, 78|Intent-to-Treat (ITT) population. Last observation carried forward. The last available distance walked for one patient was the Baseline visit; therefore, this patient was excluded from the change from baseline calculation.|||meters||Standard Deviation|Mean
1287347|NCT00158600|Primary|Summary of Patients Reporting Treatment-Emergent Adverse Events|Overall safety summary of patients experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on Treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment, i.e., alglucosidase alfa or placebo.|weeks 0-78|"All patients who received any amount of study treatment comprise the safety population. Patients were considered, for safety analysis, to be in the treatment group of the treatment they actually received.~Missing or invalid safety or resource utilization data were not replaced."|||participants|||Number
1287348|NCT00158379|Secondary|Toxicity|defined as hematological and non-hematological adverse events of grade >= grade 1|after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years||||participants|||Number
1287349|NCT00158379|Primary|Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%|Time to progression|every 3 months for up to 3 years||||months||95% Confidence Interval|Median
1287350|NCT00158262|Primary|Physiological Posterior Probability of PTSD as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 3|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven mental imagery of traumatic events (two exemplars) that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD were used to calculate each participant’s posterior probability of being classified as PTSD.|Month 3|All randomized participants with data available for analysis at Month 3. Data were missing in 6 placebo and 5 propranolol participants.|||percent probability||Standard Deviation|Mean
1287351|NCT00158262|Secondary|Clinician-Administered PTSD Scale (CAPS) Total Score|The clinician evaluated the overall frequency and intensity/severity of the participant's PTSD symptoms using the CAPS. 17 Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) PTSD symptoms were assessed using a 5-point scale for intensity where 0=none to 4=extreme and a 5-point scale for frequency where 0=never to 4=most or all of the time. The intensity score and the frequency scores were added together for a total possible score of 0 (best) to 136 (worst).|Months 1 and 3|All randomized participants with CAPS data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
1287352|NCT00158262|Primary|Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 1|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven mental imagery of traumatic events (two exemplars) that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD were used to calculate each participant’s posterior probability of being classified as PTSD.|Month 1|All randomized participants with data available for analysis at Month 1. Data were missing in 2 placebo and 2 propranolol participants.|||percent probability||Standard Deviation|Mean
1287353|NCT00158249|Secondary|Neurocognitive Function|Multiple Source Interference Test (MSIT)|Before and after 8 weeks of treatment||||Accuracy percent improvement||Standard Error|Mean
1287354|NCT00158249|Primary|Marijuana Use||Measured for 8 weeks of treatment||||Reported uses per day||Standard Error|Mean
1287355|NCT00158223|Primary|Negative Syndrome Scale (PANSS) Total Score|Severity of negative schizophrenic symptoms, The Negative Syndrome scale is compromised of seven items, each scored on severity with numeric assignments ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The items which comprise the Negative Syndrome Scale of the PANSS measure things such as emotional withdrawal, apathy, difficulty in abstract thinking, etc. The seven items which comprise the PANSS Negative Subscale has an aggregate range of 7 (absent) to 49 (extreme psychopathology), a higher score indicating more severe symptoms.|Variable change from baseline to week 12||||units on a scale||Standard Deviation|Mean
1287356|NCT00158223|Secondary|Clinical Global Impression of Change (CGIC)|The Clinical Global Impression-improvement (CGI-improvement) scale is a research rating tool, developed for use in NIMH-sponsored clinical trials provides a brief assessment of the clinician's view of the patient's overall clinical improvement prior to and after initiating a study medication. The CGI-change is rated on a seven point scale ranging from 1= very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment. Therefore, a lower score indicates more improvement in symptoms over time.|variable change from baseline to week 12||||units on a scale||Standard Deviation|Mean
1287357|NCT00158223|Primary|Positive Syndrome Scale (PANSS) Total Score|Severity of positive schizophrenic symptoms The Positive Syndrome Scale of the PANSS is comprised of seven items measuring positive such symptoms such as hallucinations, delusions, grandiosity, etc. Each item is scored on a 7 point scale of that particular symptom's severity, ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The PANSS Positive Subscale seven items has a range of a summed score from 7 (absent) to 49 (extreme psychopathology). Therefore, the higher the score, the more severe the symtpoms.|Variable change from baseline to week 12||||units on a scale||Standard Deviation|Mean
1287358|NCT00158197|Primary|Methamphetamine Use, Follow-Up|Drug use measured by urine toxicology conducted by on site EMIT assay over time|1x/month for 4 months||||percentage of negative urine samples|Participants||Number
1287359|NCT00158197|Primary|Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence|Drug use measured by urine toxicology conducted by on site EMIT assay and added up to obtain how many days of consecutive abstinence were observed for each individual|16 Weeks||||days||Standard Deviation|Mean
1287360|NCT00158197|Primary|Methamphetamine Use During Intervention|Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.|3x/week for 16 weeks|All individuals randomized were included in the analysis (i.e., intention to treat).|||percentage of negative urine samples|Participants||Number
1287361|NCT00158184|Secondary|Drug Liking|"Subjective rating of drug Liking on a scale of 0 to 100. Greater numbers indicate greater subjective report of Liking."|Highest rating obtained following adminstration of each of the 3 test doses.||||units on a scale||Standard Error|Mean
1287362|NCT00158184|Primary|Breakpoint|"Maximum number of finger presses on a computer mouse completed. The Breakpoint is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability."|Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session||||Mouse Clicks||Standard Error|Mean
1287363|NCT00158054|Secondary|All-cause Mortality|All- cause mortality|18 months||||participants|||Number
1287364|NCT00158054|Secondary|Number of Participants Experiencing Major Adverse Cardiovascular Events|The table represents the number of participants experiencing major adverse cardiovascular events|6 months||||participants|||Number
1287365|NCT00158054|Secondary|Level of Depressive Symptoms|Depressive symptoms were measured using the Beck Depression Inventory (BDI), which is a 21-item multiple choice, self-report instrument that is used to assess the severity of symptoms of depression. The score ranges from 0 (no symptoms) to 63 (worst symptoms).|6 months||||units on a scale||95% Confidence Interval|Mean
1287366|NCT00158054|Primary|Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.|Number of participants who rated their depression care as excellent or very good as a percentage.|6 months||||percentage of participants|||Number
1287367|NCT00157950|Secondary|Number of Participants With Adverse Experiences|Number of participants who reported 1 or more adverse experience.|Overall study including 14 calendar days after the last vaccination visit.|All participants who received at least 1 dose of injection.|||Participants|||Number
1287368|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 18.|Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
1287494|NCT00154297|Secondary|Duration of Dialysis|The mean duration in days of any dialysis session that occurred within the 12 month treatment period.|12 months|The number of patients analyzed includes those with any dialysis in the 12 month period|||Days||Standard Deviation|Mean
1287369|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 16.|Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
1287370|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 11.|Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
1287371|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 6.|Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
1287372|NCT00157820|Secondary|Number of Each of the Components of the CSAE|"The primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention.~Number of each of the components of CSAE, counts the number of events for each pre-determined level."|17 months||||events|||Number
1287373|NCT00157820|Primary|CSAE-score Rate(Clinical Significant Adverse Events Score Rate)|Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.|17 months|ITT|||score/month|CSAE||Number
1287374|NCT00157755|Other Pre-specified|Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)|Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 4-hour GET is calculated as % of gastric retention at 4 hours at baseline - % of gastric retention at 4 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.|||Percent retention||Inter-Quartile Range|Median
1287375|NCT00157755|Other Pre-specified|Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)|Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 2-hour GET is calculated as % of gastric retention at 2 hours at baseline - % of gastric retention at 2 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.|||Percent retention||Inter-Quartile Range|Median
1287376|NCT00157755|Other Pre-specified|Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)|The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The mental component summary (MCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on mental health. The change in MCS is calculated as MCS at baseline - MCS at 12 months. A negative change in MCS represents an improvement in QOL.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.|||Scores on a scale||Standard Deviation|Mean
1287377|NCT00157755|Other Pre-specified|Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)|The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The physical component summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health. The change in PCS is calculated as PCS at baseline - PCS at 12 months. A negative change in PCS represents an improvement in QOL.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.|||Scores on a scale||Standard Deviation|Mean
1287378|NCT00157755|Other Pre-specified|Change in Symptom Score at 12 Months Compared to Baseline.|A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The change is calculated as TSS at baseline - TSS at 12 months. A positive change represents an improvement in TSS at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.|||Scores on a scale||Standard Deviation|Mean
1287495|NCT00154297|Secondary|Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period|The number of patients who underwent any dialysis within the 12-month treatment period.|Month 12|Intention to treat (ITT) population.|||Participants|||Number
1287379|NCT00157755|Other Pre-specified|Percentage of Responders at 12 Months|Responders were defined as having a 50% or greater reduction of WVF from baseline to 12 months. The percentage of responders was estimated as the proportion of the responders among all subjects who finished the 12-month visit. The percentage of responders was tested to determine if it was statistically greater than 50%.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.|||Percentage of responders|||Number
1287380|NCT00157755|Secondary|Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline|Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.|||Percent reduction in WVF||Full Range|Median
1287381|NCT00157755|Secondary|Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF|A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON.|4.5 months and 7.5 months|The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.|||Percent reduction in symptom score||Full Range|Median
1287382|NCT00157755|Primary|Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF|Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON.|4.5 months and 7.5 months|The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.|||percent reduction in WVF||Full Range|Median
1287383|NCT00157573|Other Pre-specified|Change From Baseline of Anti-Trag Antibodies||Up to 60 months|This outcome measure was originally posted as a secondary outcome measures but was actually an exploratory endpoint. No data was collected.||||||
1287384|NCT00157573|Secondary|Number of Participants With Adverse Events (Toxicity) Grade 3 or 4|Adverse Events (previously toxicity) were graded according the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The total number of participants with adverse events graded 3 (severe) or 4 (life-threatening or disabling) are reported.|Up to 460 days|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.|||Participants|||Count of Participants
1287385|NCT00157573|Secondary|Tumor Response Rate (RR)|RR is the percentage of patients with response as assessed by the investigator using Response Evaluable Criteria in Solid Tumors (RECIST) and CA-125 Rustin criteria. Complete Response (CR) is the disappearance of all target and non-target lesions and normalization of CA-125. Partial Response (PR) is at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; in patients with no measurable disease with an informative CA-125, the 75% definitions by Rustin is used. Stable Disease is neither sufficient shrinkage for PR nor increase for PD, taking as reference the smallest sum LD since the treatment start. PD is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start or the appearance of one or more new lesions; in patients with no measurable disease with an informative CA-125, PD is defined as a rise of > 50% over baseline, confirmed by a higher value 21 days later.|Up to 60 months|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.|||Participants|||Count of Participants
1287386|NCT00157573|Secondary|Median Time to Progression (TTP)|TTP was defined as the median time in days from trial entry until progressive disease (PD) was documented as defined by RECIST criteria. PD was defined of at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In participants with no measurable disease who had an informative cancer antigen-125 (CA-125), PD was defined as a rise of > 50% over Baseline, confirmed by a subsequently higher value at least 21 days later.|Up to 60 months|No analysis was performed. No data was reported for TTP in the clinical chart that was found to be reliable or consistent in the absence of proper computed tomography (CT) surveillance.||||||
1287387|NCT00157573|Primary|Median Time to Treatment Termination (TTT)|TTT is the median time in days to discontinuing treatment with GM-CSF, sargramostim (treatment termination) e.g. time on study until progression of disease, unacceptable adverse effects, bowel obstruction, development of new ascites or pleural effusions, initiation of systemic chemotherapy, participant death, development of co-morbid diseases which make participant continuation on the trial unsafe in the judgment of the principal investigator or the treating physician or withdrawal of consent by the participant.|Up to 460 days|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual white cell count (WCC) was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.|||days||Full Range|Median
1287388|NCT00157248|Secondary|Laboratory Analyses|"Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range.~Normal ranges are defined as:~Alanine aminotransferase (ALT): 5-45 [U/L]~Aspartate aminotransferase (AST): 10-40 [U/L]~Bilirubin, total: 0.2-1.0 [mg/dL]"|5 years|All treated patients.|||participants|||Number
1287389|NCT00157248|Primary|Yearly Event Rate for Minor Bleeding|"Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds.~Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287390|NCT00157248|Secondary|Severe Adverse Event|Frequency of patients with severe adverse events.|5 years|All treated patients.|||participants|||Number
1287391|NCT00157248|Secondary|Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality|"Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287392|NCT00157248|Primary|Yearly Event Rate for Any Bleeding|Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287393|NCT00157248|Primary|Yearly Event Rate for Major + Minor/Relevant Bleeding|Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287394|NCT00157248|Primary|Yearly Event Rate for Major Bleeding|"Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287395|NCT00157248|Secondary|Yearly Event Rate of Death|Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287396|NCT00157248|Secondary|Yearly Event Rate of Other Major Adverse Cardiac Events|Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287397|NCT00157248|Secondary|Yearly Event Rate of Myocardial Infarction|Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287444|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||mg/L||Standard Deviation|Mean
1287398|NCT00157248|Secondary|Yearly Event Rate for Systemic Thromboembolism|"Time to first occurrence of any non-central nervous system systemic thromboembolism.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287399|NCT00157248|Secondary|Yearly Event Rate for Transient Ischaemic Attacks|Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287400|NCT00157248|Secondary|Yearly Event Rate of Haemorrhagic Stroke|Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287401|NCT00157248|Secondary|Yearly Event Rate of Ischaemic Stroke|Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287402|NCT00157248|Secondary|Yearly Event Rate for Stroke|Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287403|NCT00157248|Primary|Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.|Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
1287404|NCT00157209|Secondary|Number of Participants With Elevated CA27-29 Antigen Levels|CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis.|Study entry, Week 8|"Analysis population included all randomized participants. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively."|||participants|||Number
1287405|NCT00157209|Secondary|Number of Participants With Positive T-cell Proliferation|T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.|Time from randomization until cut-off date (15 March 2006)|"Analysis population included all randomized participants. N signifies total number of participants who were evaluable for this measure. T-cell measure was done only on arm A where subjects received tecemotide for induction of t-cell response. Therefore arm B BSC did not have any samples taken for this assessment."|||participants|||Number
1287406|NCT00157209|Secondary|Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score|Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items. Each item uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL.|At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.|"Analysis population included all the participants with a baseline and at least one post-baseline complete FACT-L questionnaire. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively."|||Units on a scale||Standard Deviation|Mean
1287407|NCT00157209|Primary|Overall Survival Time|Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)|Analysis population included all randomized participants.|||months||95% Confidence Interval|Median
1287408|NCT00157209|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.|From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)|Analysis population included all participants randomized in the study.|||participants|||Number
1287409|NCT00157196|Secondary|Progression Free Survival (PFS) Time|PFS was defined as duration from first administration of trial treatment until progressive disease [PD] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.|||months||95% Confidence Interval|Median
1287410|NCT00157196|Secondary|Survival Time|Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.|||months||95% Confidence Interval|Median
1287411|NCT00157196|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)|TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.|||participants|||Number
1287412|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Number of Participants With Intensive Treatment and High Dose (≤20 Exposure Days (EDs))|Immunogenicity Analysis Set- Participants with 5 consecutive study days of a mean infusion dose of FVIII >50 IU/kg within ≤20 EDs who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM|||Participants|||Number
1287413|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Race|Number of treated participants who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM|||Participants|||Number
1287414|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Genetic Risk Factor- Family History of Inhibitors|Number of treated participants who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM|||Participants|||Number
1287415|NCT00157157|Secondary|Development of Antibodies to Heterologous Proteins|Percentage of treated participants who developed antibodies to heterologous proteins (ie, Chinese Hamster Ovary Cell Protein, Murine IgG, or Recombinant Human VWF)|Assessed at baseline, throughout the duration of the study, which was to be at least 75 exposure days or 3 years (whichever came first), and at the termination visit.|Participants who received at least 1 infusion of rAHF-PFM and had assessments of heterologous antibodies|||Percentage of Participants|||Number
1287416|NCT00157157|Secondary|Adverse Events Deemed Related to Treatment|Percentage of participants who reported AEs deemed related to treatment with rAHF-PFM|Reported during the study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM|||Percentage of Participants|||Number
1287417|NCT00157157|Secondary|Assessment of Blood Loss During Surgical Procedures|Percentage of actual intraoperative blood loss compared to preoperatively predicted average and maximal blood loss in hemostatically normal matched individuals (from institutional blood bank records)|Predicted volumes preoperatively estimated and actual volumes intraoperatively recorded|Number of participants who underwent a surgical procedure with blood loss assessments|||Percentage Blood Loss||Full Range|Median
1287418|NCT00157157|Secondary|Assessment of Postoperative Hemostasis|"Number of surgical procedures managed with rAHF-PFM and with investigator's assessment of hemostasis based on a 4-point ordinal scale:~Excellent: hemostasis was as good as or better than other licensed factor VIII products for matched procedure~Good: hemostasis was probably as good as other licensed factor VIII products for matched procedure~Fair: hemostasis was clearly < optimal for matched procedure, without need to change regimen~None: bleeding from inadequate response with proper dosing, necessitating a change in regimen"|Assessed at the time of discharge from hospital or clinic|Number of participants who underwent a surgical procedure with a postoperative assessment of hemostatic efficacy|||Procedures|||Number
1287443|NCT00157014|Secondary|Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria|"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one acute rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Rejection Episodes|||Number
1287419|NCT00157157|Secondary|Assessment of Intra-operative Hemostasis|"Number of surgical procedures managed with rAHF-PFM and with surgeon's assessment of hemostasis based on a 4-point ordinal scale:~Excellent: ≤ average predicted blood loss for matched procedures in healthy individuals~Good: > average predicted blood loss, but ≤ maximal predicted blood loss for matched procedures in healthy individuals~Fair: > maximal predicted blood loss for matched procedures in healthy individuals, and hemostasis was achieved~None: uncontrolled hemostasis with proper dosing, necessitating a change in treatment regimen"|Assessed at the time of discharge from recovery room|Number of participants who underwent a surgical procedure with an intraoperative assessment of hemostatic efficacy|||Procedures|||Number
1287420|NCT00157157|Secondary|In Vivo Incremental Recovery|Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.|30 minutes pre-infusion to 30 minutes post-infusion|Participants who received pharmacokinetic rAHF-PFM infusions, did not develop inhibitors, and had assessments|||IU/dL per IU/kg||Full Range|Median
1287421|NCT00157157|Secondary|Weekly rAHF-PFM Utilization|"Weight-Adjusted Weekly Dose for Prophylaxis, On-Demand Treatment, and Perioperative Management.~rAHF-PFM dose determined by the investigator (ie: standard regimen [25-50 IU/kg body weight, 3-4 times per week]; modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). Dosing to treat BEs was at investigator's discretion and in accordance with institution’s standard of care.~rAHF-PFM was administered I.V. via bolus infusion, except for perioperative management when it was given either by continuous or bolus infusion."|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period|||IU/kg||Full Range|Median
1287422|NCT00157157|Secondary|Annualized Rate of Bleeding Episodes|Number of bleeding episodes per subject annualized over 1 year for all etiologies|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period|||bleeding episodes per subject per year||Full Range|Median
1287423|NCT00157157|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes|"Number of rAHF-PFM-treated bleeding episodes with treater assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within ~8 hrs after infusion. Requires >1 infusion for complete resolution; or~None: No improvement or condition worsens."|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|"Participants who received at least 1 infusion of rAHF-PFM and had at least 1 treated bleeding episode. The 1 rating of none was for the first 2 infusions, the last infusion was rated as good."|||bleeding episodes|||Number
1287424|NCT00157157|Secondary|Bleeding Episodes Treated With 1 to ≥4 Infusions|The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM for the treatment of bleeding episodes|||Bleeding episodes|||Number
1287425|NCT00157157|Primary|Factor VIII Inhibitor Development|Percentage of treated participants who developed factor VIII inhibitors|Assessed during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM|||percentage||95% Confidence Interval|Number
1287426|NCT00157014|Secondary|Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)|"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
1287427|NCT00157014|Secondary|Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)|A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.|26 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
1287428|NCT00157014|Secondary|Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)|"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||MCAR per patient||Standard Deviation|Mean
1287429|NCT00157014|Secondary|Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)|A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Rejection Episodes|||Number
1287430|NCT00157014|Secondary|Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)|Severe Acute Rejection was defined as rejection with ISHLT Grade 4.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
1287431|NCT00157014|Secondary|Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)|"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant."|52 Weeks|The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis.|||Days||Standard Deviation|Mean
1287432|NCT00157014|Secondary|Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)|"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one rejection episode."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Rejection Episodes|||Number
1287433|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||mg/L||Standard Deviation|Mean
1287434|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||mg/L||Standard Deviation|Mean
1287435|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||nM||Standard Deviation|Mean
1287436|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
1287437|NCT00157014|Secondary|Number of Patients With Treatment Failure and Crossover for Treatment Failure|"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
1287438|NCT00157014|Secondary|Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52|A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.|26 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
1287439|NCT00157014|Secondary|Mean Cases of Acute Rejection (MCAR) Per Patient|"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||MCAR per patient||Standard Deviation|Mean
1287440|NCT00157014|Secondary|Number of Cardiac Rejection Episodes Requiring Treatment|The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Rejection Episodes|||Number
1287441|NCT00157014|Secondary|Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection|Severe Acute Rejection is defined as rejection with ISHLT Grade 4.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
1287442|NCT00157014|Secondary|Time to First Acute Rejection Episode Following de Novo Cardiac Transplant|"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant."|52 Weeks|The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis.|||Days||Standard Deviation|Mean
1288269|NCT00144339|Secondary|Time to First Exacerbation|Chronic obstructive pulmonary disease (COPD) exacerbation|From Day 1 to 4 years||||months||95% Confidence Interval|Median
1287445|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
1287446|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~IL= Interleukin"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
1287447|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||g/L||Standard Deviation|Mean
1287448|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ng/mL||Standard Deviation|Mean
1287449|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ug/L||Standard Deviation|Mean
1287450|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~BNP= Brain Natriuretic Peptide"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ng/L||Standard Deviation|Mean
1287451|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~GSH/GSSG= ratio of reduced to oxidised glutathione"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Ratio||Standard Deviation|Mean
1287452|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||nM||Standard Deviation|Mean
1287453|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~T-bars = thiobarbituric acid reactive substances"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||nmol/mL||Standard Deviation|Mean
1287454|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
1287455|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~hsCRP= high-sensitivity C Reactive Protein"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||mg/L||Standard Deviation|Mean
1287456|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||μmol/L||Standard Deviation|Mean
1287457|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ng/mL||Standard Deviation|Mean
1287458|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~s-ICAM= soluble-intracellular adhesion molecule"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ng/mL||Standard Deviation|Mean
1287459|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1|"Change is defined as Week 52 assessment – Pre-Transplant assessment.~MCP-1= monocyte chemoattractant protein-1"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
1287460|NCT00157014|Primary|The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)|"The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK.~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment."|2 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Densitometry / Densitometry of GAPDH||Standard Deviation|Mean
1287461|NCT00157014|Primary|The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies|"The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase).~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment."|2 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Densitometry / Densitometry of GAPDH||Standard Deviation|Mean
1287462|NCT00156936|Primary|Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|Up to 3 years|Safety population includes all enrolled subjects who received at least 1 dose of study drug (VIVITROL 380 mg) in this extension study.|||Participants|||Number
1287463|NCT00156923|Primary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).|Up to 3.5 years of monthly treatment|Subjects who received at least 1 injection of study drug were included in the safety analyses|||Participants|||Number
1287464|NCT00156910|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Episodes|Mean change from baseline in frequency (number) of migraine/probable migraine headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours and met ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat|||Migraine/Prob Migraine Headache Episodes||Standard Deviation|Mean
1287465|NCT00156910|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Days|Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat|||Migraine/Probable Migraine Headache Days||Standard Deviation|Mean
1287466|NCT00156910|Secondary|Change in Frequency of Acute Headache Pain Medication Intakes|Mean change from baseline in frequency (number) of acute headache pain medication intakes during the 28 day period ending with Week 24. Medication intakes defined as the number of times a patient took acute headache pain medication regardless of dose or type/number of medications taken at the same time.|Baseline, Week 24|Intent to Treat|||Medication Intakes||Standard Deviation|Mean
1287467|NCT00156910|Secondary|Change in Frequency of Headache Days|Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache|Baseline, Week 24|Intent to Treat|||Headache Days||Standard Deviation|Mean
1287468|NCT00156910|Primary|Change in Frequency of Headache Episodes|Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.|Baseline, Week 24|Intent to Treat|||Headache Episodes||Standard Deviation|Mean
1287469|NCT00156819|Primary|Treatment Failure|The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.|16 weeks||||participants|||Number
1287470|NCT00156715|Secondary|Clinical Symptoms|The main outcome measure of clinical symptoms was the Positive and Negative Symptoms Scale. This is a 30 item scale for assessing patients diagnosed with schizophrenia. Each item is rated on a 1 (absent) to 7 (extreme) scale. The minimum total score is 30 and the maximum is 210.|12 Weeks|Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in this analysis. Participants from Site 2 were all admitted to the study directly from the hospital, which could have affected their behavior.|||Units on a scale||Standard Deviation|Mean
1288287|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1287471|NCT00156715|Primary|Mean Number of Drinking Days Per Week|Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit.|12 Weeks|Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in the analysis. Participants from Site 2 were all admitted to the study directly from the hospital which could have affected their alcohol consumption.|||Drinking Days per Week||Standard Deviation|Mean
1287472|NCT00156533|Secondary|Wake After Sleep Onset (WASO)|Number of subjects with any reduction in WASO at post-tx compared to baseline where mean WASO = mean of daily values for one week calculated from sleep diary values.|Baseline and Post-Treatment (12 weeks)|Completers|||participants|||Number
1287473|NCT00156533|Primary|Sleep Latency (SL)|Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.|Baseline and Post-treatment (12wks)|Completers Only|||participants|||Number
1287474|NCT00156390|Secondary|Echocardiographic Changes|These parameters compared the echocardiographic measures at baseline prior to device implantations to those obtained 6 to 12 months after device implantation. Data for ESV and EF are presented as percent relative change (standard deviation)|1 year|Echo Results. The numbers in the outcome measure data table represent the patients who had both baseline and follow-up echo data. Patients who died or were lost to follow-up before having their follow-up echocardiogram are not included in this analysis.|||percent change||Standard Deviation|Mean
1287475|NCT00156390|Primary|Minnesota For Living With Heart Failure Questionnaire|"Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = no heart failure did not prevent one from living as they want and 5= yesheart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life."|1 year||||units on a scale||Standard Deviation|Mean
1287476|NCT00156247|Secondary|Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|6 months||||percent|||Number
1287477|NCT00156247|Secondary|Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|6 months||||percent|||Number
1287478|NCT00156247|Primary|Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|6 months||||percent|||Number
1287479|NCT00156065|Primary|Median Survival Time of Effect|"Kaplan-Meier estimate of median time to loss of effect in subjects who had >=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension.~PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.~Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy."|52 Weeks|These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.|||Days||95% Confidence Interval|Median
1287480|NCT00156065|Primary|Loss of Effect Over Time|"Loss of effect in subjects who had >=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension.~PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.~Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy."|Throughout the 52 weeks of the trial.|These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.|||Participants|||Number
1287481|NCT00156013|Secondary|Toxicity|Number of Participants with Toxicity|5 years||||Participants|||Count of Participants
1287482|NCT00156013|Primary|Phase II Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|5 years||||Participants|||Count of Participants
1287483|NCT00156013|Primary|Phase I Maximum Tolerated Dose|Maximum Tolerated Dose for Clofarabine. Cohorts of 3 patients each will receive doses of clofarabine increased in increments as follows: 4, 6, 8, 10, 12,…etc mg/m2/day for 5 days. The dose level immediately below the MTD will be used to treat patients in the Phase II part of the study. Starting dose of 4 mg/m2.|days 1 -28, maximum 6 cycles|Per protocol guidelines for accrual to the cohorts.|||mg/m^2|||Number
1288288|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline|TS - treated set|||Score on a scale||Standard Deviation|Mean
1287484|NCT00154466|Secondary|Angiogenic Cytokines at Baseline and 3-month Follow-up|Angiogenic cytokines such as vascular endothelial growth factor (VEGF), stromal-derived factor-1 (SDF-1) and stem cell factor (SCF) are known to increase the formation of new vessels at ischaemic sites and thus enhance myocardial perfusion. To rule out any effect of short-term exercise on cytokines levels, blood samples were always taken after at least 72 h of physical inactivity and overnight fasting when the subject had rested in the sitting position for at least 10 min. The plasma samples were immediately frozen and stored at −70°C. High-sensitivity ELISA (Bender MedSystems, R&D) were used to measure plasma levels of SCF, SDF-1 and VEGF according to the manufacturer’s protocols.|3 months|We calculated that we would need 18 patients in each group to achieve a power of at least 80% to detect a 20% difference in MBF change between study groups, with a two-sided significance level of p<0.05, and a 20% increase for the stress MBF change from baseline to 3 months' follow-up. The analysis was intention-to-treat.|||pg/ml||Standard Deviation|Mean
1287485|NCT00154466|Primary|Myocardial Blood Flow at Baseline and 3-month Follow-up|First-pass, contrast-enhanced myocardial perfusion images acquired for 80 heart beats in the left ventricle. Short-axis views were obtained after intravenous administration of gadodiamide. Perfusion studies were performed at rest and during the stress induced by a 4 min infusion of dipyridamole at a concentration of 0.14 mg/kg of body weight per minute.To determine absolute MBF values at rest and stress status, we adopted a model-independent deconvolution method proposed by Jerosch-Herold et al, a method that was previously validated in experimental animal studies by comparison with blood-flow measurements with radiolabelled microspheres.|3 months|Eligible patients were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. Healthy controls underwent the test of myocardial perfusion only at baseline. The analysis was intention-to-treat.|||ml/min/g||Standard Deviation|Mean
1287486|NCT00154375|Secondary|Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations|National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each AE term. Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|6 months - 1 year|The safety population consisted of randomized patients with at least one dose of randomized medication.|||Participants|||Number
1287487|NCT00154375|Primary|Percentage of Participants With Progression Free Survival (PFS) During the Study Duration|PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).|6 months -1 year|The ITT population consists of all randomized patients, analyzed according to their randomized treatment.|||Percentage of Participants||95% Confidence Interval|Number
1287488|NCT00154310|Secondary|Number of Participants Who Experienced an Adverse Event or Serious Adverse Event|Additional information about the number of participants who experienced Adverse Events (greater than 5%) or Serious Adverse Events can be found in the Adverse Event section.|Aes from end of core study period (month 12) to end of follow-up period (month 60)|Safety Population consisted of all participants in whom transplantation was performed and who were treated with at least one dose of any immunosuppressive medication.|||Participants|||Number
1287489|NCT00154310|Secondary|Changes in Cardiovascular Risk From Month 4.5 to Final Assessment at Month 12|An updated 1991 Framingham coronary prediction algorithm was used to estimate the total risk of developing coronary heart diseases (CHD) over the course of 10 years. Risk was calculated separately for male and females. To calculate risk, points were assigned for each of the following risk factors: age, levels of LDL cholesterol, HDL cholesterol, blood pressure, cigarette smoking, and diabetes mellitus. The sum of the individual risk factor points gives a total point score, which ranges from -5 to 18 for men and -16 to 24 for women. Higher points indicate a higher risk for CHD.|Month 4.5 and Month 12|Safety Population for whom data was available at Month 4.5 and end of treatment.|||Points||Standard Deviation|Mean
1287490|NCT00154310|Secondary|Number of Participants With Occurrence of Treatment Failures|Treatment failures defined as a composite endpoint of biopsy proven acute rejection, graft loss, death, loss to follow up and discontinuations due to lack of efficacy or toxicity, or conversion to another regimen (at least one condition must be present).|up to or at Month 12|Intention to treat (ITT) population (Randomized Patients).|||Participants|||Number
1287491|NCT00154310|Secondary|Number of Participants With Occurrence of Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death|The number of participants with occurrence of biopsy proven acute rejection (BPAR), graft loss, or death up to Month 12 during the randomized treatment period. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III according to Banff 97 classification. A graft core biopsy was performed prior to 24 hours following initiation of graft rejection therapy. The allograft is presumed to be lost on the day the patient starts dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|Up to Month 12|Intent to Treat Population (Randomized Patients)|||Participants|||Number
1287492|NCT00154310|Primary|Renal Function (Nankivell Formula) at Month 12 Post Transplantation.|Renal function at the end of the trial assessed as mean absolute values of the glomerular filtration rate (GFR) calculated by Nankivell formula 12 months after renal transplantation. The Nankivell formula: GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)^2 + C ; where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. Estimated GFR is expressed in mL/min per 1.73m^2.|at Month 12 post transplantation|Intent to Treat Population (randomized patients); Last Observation Carried Forward (LOCF). One patient in|||mL/min /1.73m^2||Standard Deviation|Mean
1288309|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 64)||Baseline to Week 64|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287496|NCT00154297|Secondary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.|"The primary efficacy variable was the “primary failure endpoint” at 12 months defined as the occurrence of one or more of the following events within the first 12 months:~delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation~efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)~wound healing disorder related to initial transplant surgery"|at 12 Month post-transplantation|Intention to treat (ITT) population.|||Participants|||Number
1287497|NCT00154297|Secondary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.|"The primary efficacy variable was the “primary failure endpoint” at 6 months defined as the occurrence of one or more of the following events within the first 6 months:~delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation~efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)~wound healing disorder related to initial transplant surgery"|at 6 Month post-transplantation|Intention to treat (ITT) population.|||Participants|||Number
1287498|NCT00154297|Primary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months|“In Failure”, is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).|Month 3|Intention to treat (ITT) population.|||Participants|||Number
1287499|NCT00154284|Secondary|Calculated Creatinine Clearance at 6 Month and 12 Month|"Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl[mL/min]) is shown below:~CrCl[mL/min] = (140 – A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female."|6 month and 12 months|Intention to treat (ITT) population.|||mL/min||Standard Deviation|Mean
1287500|NCT00154284|Secondary|Serum Creatinine at Month 6 and 12|serum creatinine summarized by mean and standard deviation|6 month and 12 months|Intention to treat (ITT) population.|||µmol/L||Standard Deviation|Mean
1287501|NCT00154284|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up|Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables.|Month 12|Intention to treat (ITT) population.|||Participants|||Number
1287502|NCT00154284|Primary|Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)|"Nankivell’s formula for calculated GFR is shown below:~GFR [mL/min] = 6.7/C + W/4 – UREA/2 – 100/H2+ 35 (25 for females). Where W is body weight at specific visit [kg], H is height at specific visit [m], C is the serum concentration of creatinine [mmol/L], and UREA is the serum concentration of urea [mmol/L]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441*BUN. If a GFR value from Nankivell formula was less than 10 [mL/min], then the value was assigned as 10 [mL/min]."|At Month 3 and Month 12|Intention to treat (ITT) population.|||mL/min per 1.73 m^2||Standard Deviation|Mean
1287503|NCT00154102|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007|Safety Population|||participants|||Number
1287504|NCT00154102|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.|at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population|||scores on a scale||Standard Error|Least Squares Mean
1287505|NCT00154102|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|1125 subjects (566 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire & were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96|||scores on a scale||Standard Error|Least Squares Mean
1287506|NCT00154102|Secondary|Participants With No Residual Tumor After Metastatic Surgery|Participants with no residual tumor after on-study surgery for metastases|time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007|ITT population (allocation to treatment groups as randomized and treated)|||Participants|||Number
1287567|NCT00153101|Secondary|ONTARGET. New Onset of Atrial Fibrillation|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without atrial fibrillation at baseline.|||participants|||Number
1287507|NCT00154102|Secondary|Duration of Response - Independent Review Committee (IRC) Assessments|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)|||months||95% Confidence Interval|Median
1287508|NCT00154102|Secondary|Disease Control Rate - Independent Review Committee (IRC) Assessments|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)|||percentage of participants||95% Confidence Interval|Number
1287509|NCT00154102|Secondary|Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009|||percentage of participants||95% Confidence Interval|Number
1287510|NCT00154102|Secondary|Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009|||percentage participants||95% Confidence Interval|Number
1287511|NCT00154102|Secondary|Best Overall Response Rate - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)|||percentage of participants||95% Confidence Interval|Number
1287512|NCT00154102|Secondary|Overall Survival Time (KRAS Mutant Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009|||months||95% Confidence Interval|Median
1287513|NCT00154102|Secondary|Overall Survival Time (KRAS Wild-Type Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009|||months||95% Confidence Interval|Median
1287514|NCT00154102|Secondary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|ITT population (allocation to treatment groups as randomized and treated)|||months||95% Confidence Interval|Median
1287515|NCT00154102|Primary|Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009|||months||95% Confidence Interval|Median
1287516|NCT00154102|Primary|Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009|||months||95% Confidence Interval|Median
1287517|NCT00154102|Primary|Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Primary analysis on Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||months||95% Confidence Interval|Median
1287620|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at 12-months Follow-up|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
1287518|NCT00154063|Secondary|Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. The data is presented as percentage of participants.|Week 5 to Week 19|ITT Population|||Percentage of Participants|||Number
1287519|NCT00154063|Secondary|Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)|Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.|Week 5 to Week 19|ITT Population|||Percentage of Participants|||Number
1287520|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Work or School|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 1 , the number of missed work or school because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
1287521|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Non-Work Activities|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 5, the number of days when participant miss leisure or social activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
1287522|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Housework|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 3, the number of days when participant skipped performing household chores or regular household activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
1287523|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Work or School|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 2, the number of days with reduced productivity by at least half at school or work because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
1287524|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Housework|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 4, the number of days when productivity in household work reduced by half of more because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
1287525|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headaches|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 6, the number of days with headache (Headache which lasted more than one day was counted as each day) was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
1287526|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headache Pain Score|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 7, pain due to headache was assessed on a scale of 0-10 with 0 being no pain and 10 being the most painful.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||units on a scale||Standard Deviation|Mean
1287527|NCT00154063|Secondary|Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF)|"The PGIC was a self-evaluation scale for each patient to assess his or her status compared to baseline in migraine headache frequency and intensity, the occurrence of adverse events, and overall functional status, measured on a 7-point scale. The scale ranges from very much improved with a score of 1 to very much worse with a score of 7. A responder is defined as being very much improved or much improved. The data is presented as number of participants. LOCF = last observation carried forward (ie, observation from last phase with active treatment)"|Baseline to Week 23|ITT Population|||Participants|||Number
1287528|NCT00154063|Secondary|Change From Baseline in Number of Days With Migraine Attack Per 28 Days in Treatment Phase (LOCF)|A migraine attack day was defined as a calendar day (from 0 hours to 24 hours) during which at least one migraine attack took place. If the migraine attack continues through midnight, each day will be counted separately. Efficacy analyses were performed using both the 24-hour and 48-hour rule. Data is presented as mean number of days with migraine attack per 28 days +/- standard error.|Baseline to Week 19|ITT Population|||Days||Standard Error|Mean
1288310|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 56)||Baseline to Week 56|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287529|NCT00154063|Secondary|Change From Baseline in Number of Days Requiring Symptomatic Rescue Medication Per 28 Days in Treatment Phase (LOCF)|The number of days requiring symptomatic rescue medication was calculated as the number of calender days during the migraine attack when the patient took one or more migraine rescue medications as recorded on the participant's diary. The calendar date(s) during which medication was taken will be used for calculations. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean days +/- standard error.|Baseline to Week 19|ITT Population|||Days||Standard Error|Mean
1287530|NCT00154063|Primary|Change From Baseline in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment)|Baseline to Week 19|The efficacy analysis was performed on the Intention to treat (ITT) Population, which was defined as all randomized subjects who received at least 1 dose of double-blind study medication, and had baseline and postbaseline migraine assessments in at least 1 phase.|||Migraine period||Standard Error|Mean
1287531|NCT00154063|Secondary|Change From Baseline in Migraine Period Frequency Per 28 Days in Maintenance Phase|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline.|Baseline, Week 11 to Week 19|ITT Population|||Migraine period||Standard Error|Mean
1287532|NCT00154063|Secondary|Change From Baseline in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)|Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.|Baseline to Week 19|ITT Population|||Migraine attack||Standard Error|Mean
1287533|NCT00154063|Secondary|Change From Baseline in Average Migraine Severity Per Migraine Attack in Treatment Phase (LOCF)|The average migraine attack severity in each treatment phase was calculated using the sum of the severity of migraine attacks during the treatment phase, divided by the number of qualified migraine attacks. The scale of severity for each migraine attack ranges from 0 to 100, with higher scores indicating increased migraine severity. Efficacy analyses were performed using both the 24-hour and 48-hour rule.|Baseline to Week 19|ITT Population|||Units on a Scale||Standard Error|Mean
1287534|NCT00154063|Secondary|Change From Baseline in Average Duration Per Migraine Attack in Treatment Phase (LOCF)|The duration of a migraine attack was the sum of the duration (in hours) of each migraine headache that was collapsed to form the migraine attack. The time between the offset of first migraine headache and the onset of the next migraine headache was not counted in the duration of migraine attack. The average duration of the migraine attacks in each phase was calculated as the total duration (in hours) of the migraine attacks during each phase, divided by the number of migraine attacks in the corresponding treatment phase. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean hours +/- standard error.|Baseline to Week 19|ITT Population|||Hours||Standard Error|Mean
1287535|NCT00153985|Secondary|The Incidence of Grade II-IV Acute Graft vs. Host Disease.|Outcome was measured by incidence and severity of acute and chronic GVHD following donor stem cell infusion.|3 years|All patients enrolled.|||participants|||Number
1287536|NCT00153985|Secondary|Solid Organ Toxicity Related to the Conditioning Regimen.|Outcome was measured by the assessment of organ toxicity related to Busulfex, fludarabine and alemtuzumab.|3 years|All patients enrolled.|||participants|||Number
1287537|NCT00153985|Primary|Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy.|Outcome was measured by ANC >500 for three consecutive days prior to day 30 after PBSC infusion, >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods prior to day 45 after PBSC infusion and >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods after day 180 after PBSC infusion.|3 years|All patients enrolled.|||participants|||Number
1287538|NCT00153920|Secondary|Any Grade Neuropathic Pain Events|Any grade neuropathic pain events based on CTCAEv2 as reported on case report forms.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.|||adverse events|||Number
1287539|NCT00153920|Secondary|Any Grade Sensory Neuropathy Events|Any grade sensory neuropathy events based on CTCAEv3 as reported on case report forms.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.|||adverse events|||Number
1287565|NCT00153101|Primary|TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287540|NCT00153920|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing soft tissue plasmacytomas and/or lytic lesions or new; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause).|Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis.|The analysis population is comprised of eligible and treated participants.|||months||95% Confidence Interval|Median
1287541|NCT00153920|Secondary|Time to Progression (TTP)|TTP based on the Kaplan-Meier method is defined as the time from start of treatment to documentation of disease progression (PD). Participants without evidence of PD were censored at the latest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing or new soft tissue plasmacytomas and/or lytic lesions; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause).|Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months.|The analysis population is comprised of eligible and treated participants.|||months||95% Confidence Interval|Median
1287542|NCT00153920|Secondary|Very Good Partial Response (VGPR) Rate|Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; >=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a >90% decrease in the difference between involved and uninvolved FLC levels.|Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.|||proportion of participants||95% Confidence Interval|Number
1287543|NCT00153920|Primary|Objective Response (OR) Rate|Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; <5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category.|Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.|||proportion of participants||95% Confidence Interval|Number
1287544|NCT00153816|Secondary|Advanced Colorectal Lesions|Includes: adenomas >=1 cm, adenomas with high grade dysplasia, adenomas with villous features, or cancer.|1 to 10 years|Subjects are included if they had a follow-up exam at least one year after randomization and sufficient histology available to ascertain the endpoint.|||percentage of subjects||95% Confidence Interval|Number
1287545|NCT00153816|Primary|Colorectal Adenomas||1 to 10 years|Subjects are included if they had a follow-up exam at least one year after randomization and had sufficient histology available to ascertain the endpoint.|||percentage of subjects||95% Confidence Interval|Number
1287546|NCT00153179|Primary|Difference in Insulin-mediated Skeletal Muscle Glucose Utilization Between Test Agent and Placebo|Insulin sensitivity (M) is measured by using a hyperinsulinaemic–euglycaemic clamp. Insulin sensitivity (M) was calculated as the average glucose infusion rate (mg/kg of body weight per min) over the last 30 min of the clamp. Higher values indicate better outcomes (more insulin sensitive), while lower values indicate more insulin resistance.|baseline, 7 days|The data for this outcome measure was lost when the investigator left the institution, so the measure was not analyzed.||||||
1287547|NCT00153179|Primary|Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome|Flow mediated dilation is calculated as follows: A resting arterial diameter measurement is obtained using the average of 10 EKG-gated ultrasound images. Next, an occlusive pressure is applied (using a blood pressure cuff inflated to a suprasystolic pressure)for a period of 5 minutes. After 5 minutes, the cuff is rapidly deflated. This produces a reactive hyperemic response which is captured via ultrasound at 1 minute post cuff deflation (also 10 EKG-gated images averaged). The diameter of the artery following reactive hyperemia is calculated and compared to the resting diameter to obtain a percent dilation. This is flow-mediated dilation.|7 days||||Flow mediated dilation||Standard Deviation|Mean
1287566|NCT00153101|Secondary|TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287548|NCT00153166|Secondary|'M' = Whole Body Insulin Sensitivity|A hyperinsulinemic-euglycemic clamp was performed prior to and during FDG-PET imaging to measure insulin sensitivity and to standardize metabolic conditions. Subjects were required to fast for 8 hours prior to the study. Patients were given a primed insulin infusion of 2 mU/kg/min. Serum glucose measurements were made at five-minute intervals from an arterialized venous sample achieved by placing the hand in a warming box at 50°C. Blood glucose levels are checked every 5 minutes and 20% dextrose infusion is adjusted to maintain a serum glucose level of approximately 80 mg/dL. Subjects were considered to have achieved steady state when the dextrose infusion rate required to maintain a serum glucose level of 80 mg/dL varied by no greater than 5%. To compute the steady-state glucose disposal rate, we averaged the glucose infusion rates over the last 20 minutes of the clamp and applied a “space correction” to account for small changes in serum glucose levels over that time period.|every 5 minutes for 20 minutes|Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.|||mg/kg/min||Inter-Quartile Range|Median
1287549|NCT00153166|Primary|Lower Extremity Skeletal Muscle Glucose Uptake|Net calf skeletal muscle glucose uptake determined by Patlak modeling.|60 minutes|Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.|||umol/kg/min||Standard Deviation|Mean
1287550|NCT00153101|Secondary|TRANSCEND. Newly Diagnosed Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287551|NCT00153101|Secondary|TRANSCEND. Cardiovascular Revascularization Procedure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287552|NCT00153101|Secondary|TRANSCEND. Newly Diagnosed Diabetes|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.|56 months|Only for patients of TRANSCEND trial treated with Telmisartan 80mg or Telmisartan 80mg placebo daily for 56 months without diabetes at baseline.|||participants|||Number
1287553|NCT00153101|Secondary|TRANSCEND. Cognitive Decline|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.|56 months|Only patients of the TRANSCEND trial treated with Telmisartan 80mg or telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.|||participants|||Number
1287554|NCT00153101|Secondary|TRANSCEND. New Onset of Atrial Fibrillation|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287555|NCT00153101|Secondary|TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria|TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287556|NCT00153101|Secondary|TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria|TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287557|NCT00153101|Secondary|TRANSCEND. New Macroalbuminuria|TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine [Crea] in patients with a UACR <300 mg/g Crea at baseline|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287558|NCT00153101|Secondary|TRANSCEND. New Microalbuminuria|TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine [Crea] in patients with a UACR <30 mg/g Crea at baseline|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287559|NCT00153101|Secondary|TRANSCEND. Progression to ESRD|TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73m²|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287560|NCT00153101|Secondary|TRANSCEND. Doubling of Serum Creatinine|TRANSCEND. Nephropathy subcategory: doubling of serum creatinine|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287561|NCT00153101|Secondary|TRANSCEND. Hospitalization for Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287562|NCT00153101|Secondary|TRANSCEND. Non-fatal Stroke|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287563|NCT00153101|Secondary|TRANSCEND. Non-fatal Myocardial Infarction|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction.|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287564|NCT00153101|Secondary|TRANSCEND. Cardiovascular Death|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death.|56 months|FAS of the TRANSCEND trial|||participants|||Number
1287568|NCT00153101|Secondary|ONTARGET. Cognitive Decline|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.|||participants|||Number
1287569|NCT00153101|Secondary|ONTARGET. Newly Diagnosed Diabetes|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without baseline diabetes.|||participants|||Number
1287570|NCT00153101|Secondary|ONTARGET. Cardiovascular Revascularization Procedure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET).|56 months|FAS of the ONTARGET trial|||participants|||Number
1287571|NCT00153101|Secondary|ONTARGET. Newly Diagnosed Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287572|NCT00153101|Secondary|ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria|ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287573|NCT00153101|Secondary|ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria|ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria|56 months|FAS of the ONTARGET trial|||participants|||Number
1287574|NCT00153101|Secondary|ONTARGET. New Macroalbuminuria|ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <300 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287575|NCT00153101|Secondary|ONTARGET. New Microalbuminuria|ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <30 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287576|NCT00153101|Primary|ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients|"ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.~These renal outcomes were not adjudicated (apart from death)."|56 months|Subset of the Full Analysis Set (FAS [DN]) consisting of all randomised patients with diabetic nephropathy (UACR ≥300 mg/g Crea) of the ONTARGET trial.|||participants|||Number
1287577|NCT00153101|Secondary|ONTARGET. Progression to ESRD|ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m².|56 months|FAS of the ONTARGET trial|||participants|||Number
1287578|NCT00153101|Secondary|ONTARGET. Doubling of Serum Creatinine|ONTARGET. Nephropathy subcategory: doubling of serum creatinine|56 months|FAS of the ONTARGET trial|||participants|||Number
1287579|NCT00153101|Secondary|ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients|Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial|||participants|||Number
1287580|NCT00153101|Secondary|ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients|ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial|||participants|||Number
1287581|NCT00153101|Secondary|ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients|Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial|||participants|||Number
1287582|NCT00153101|Secondary|ONTARGET. Hospitalization for Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287583|NCT00153101|Secondary|ONTARGET. Non-fatal Stroke|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287584|NCT00153101|Secondary|ONTARGET. Non-fatal Myocardial Infarction|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287585|NCT00153101|Secondary|ONTARGET. Cardiovascular Death|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287586|NCT00153101|Secondary|ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke|56 months|FAS of the ONTARGET trial|||participants|||Number
1287587|NCT00153101|Primary|ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the ONTARGET trial|||participants|||Number
1287588|NCT00153062|Primary|Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)||time since randomization; follow-up period is 1.5 to 4.4 years||||Participants|||Number
1287589|NCT00153062|Secondary|Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)||Randomization to final patient contact|Patients who did not have diabetes mellitus at baseline were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.|||Participants|||Number
1287590|NCT00153062|Secondary|Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)|Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure|time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.|||Participants|||Number
1287591|NCT00153062|Secondary|Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)|Number of patients with any of stroke, myocardial infarction, vascular death|time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.|||Participants|||Number
1287592|NCT00153062|Primary|Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)||time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.|||Participants|||Number
1287593|NCT00152971|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 12-15 days|Treated set|||Participants|||Number
1287594|NCT00152971|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up|||Participants|||Number
1287595|NCT00152971|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op|||Participants|||Number
1287596|NCT00152971|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op|||Participants|||Number
1287597|NCT00152971|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
1287598|NCT00152971|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
1287599|NCT00152971|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
1287600|NCT00152971|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)|||Participants|||Number
1287621|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at Baseline|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Baseline|Intention to treat analysis although data for participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1288319|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response defined as Viral Load<50 copies/mL|Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1287601|NCT00152971|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 12-15 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)|||Participants|||Number
1287602|NCT00152763|Secondary|Percentage of Participants Who Received ICD Therapies|Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.|12-months follow-up||||Percentage of participants|||Number
1287603|NCT00152763|Secondary|SF-36 Physical Component Summary Score at 12-months Follow-up|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
1287604|NCT00152763|Secondary|SF-36 Physical Component Summary Score at 6-months Follow-up|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
1287605|NCT00152763|Secondary|SF-36 Physical Component Summary Score at Baseline|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Baseline||||units on a scale||Standard Deviation|Mean
1287606|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
1287607|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
1287608|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
1287609|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
1287610|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
1287611|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at Baseline|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
1287612|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Twelve-months follow-up|Intention to treat analysis although data from participants who died were omitted from analysis|||units on a scale||Standard Deviation|Mean
1287613|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Six-months follow-up|Intention to treat analysis although data from participants who died were omitted from analysis|||units on a scale||Standard Deviation|Mean
1287614|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at Baseline|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Baseline|Intention to treat analysis although data from participants who died were omitted from analysis|||units on a scale||Standard Deviation|Mean
1287615|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
1287616|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
1287617|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at Baseline|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
1287618|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at 12-months Follow-up|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Twelve-months follow-up|Intention to treat analysis although data for participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1287619|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at 6-months Follow-up|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Six-months follow-up|Intention to treat analysis although data for participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1287622|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Twelve-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1287623|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Six-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1287624|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Baseline|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1287625|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Twelve-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1287626|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at 6-months Follow-up|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
1287627|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Six-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1287628|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at Baseline|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Baseline||||units on a scale||Standard Deviation|Mean
1287629|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at Baseline|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Baseline|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
1287630|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 7 (week 48)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.|||Number of subjects|||Number
1287631|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 5 (week 24)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.|||Number of subjects|||Number
1287632|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 7 (week 48)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.|||Number of subjects|||Number
1287633|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 5 (Week 24)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.|||Number of subjects|||Number
1288311|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 48)||Baseline to Week 48|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287634|NCT00152516|Secondary|Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)|The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.|Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)|At baseline there were 98 subjects with valid Memory Screen composite scores (mean=85.5, standard deviation=18.7). Of these 98 subjects, 87 had valid scores at Visit 5 (week 24) and 80 at Visit 7 (week 48).|||Score on a scale||Standard Deviation|Mean
1287635|NCT00152516|Secondary|Subject (>=8 Years Old) Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects >= 8 years old for whom the assessment was performed|||Percentage of Participants|||Number
1287636|NCT00152516|Secondary|Parent/Guardian Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects for whom the assessment was performed|||Percentage of Participants|||Number
1287637|NCT00152516|Secondary|Investigator Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects for whom the assessment was performed|||Percentage of Participants|||Number
1287638|NCT00152516|Secondary|Percent of Subjects With Each Seizure Type During the Evaluation Period|"Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).~Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).~Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).~A subject could experience more than one seizure type."|Evaluation period (48 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data.|||Percentage of Participants|||Number
1287639|NCT00152516|Secondary|Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period|"The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.~The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks."|greater than or equal to 24 weeks, greater than or equal to 40 weeks|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.|||Percentage of Participants|||Number
1287640|NCT00152516|Secondary|Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with greater than 24 weeks of exposure|Intention to Treat (ITT) subjects with > 24 weeks of exposure and treatment period seizure data|||Percentage of Days||Inter-Quartile Range|Median
1287641|NCT00152516|Secondary|Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with up to 24 weeks of exposure|Intention to Treat (ITT) Subjects with <= 24 Weeks of Exposure and treatment period seizure data|||Percentage of Days||Inter-Quartile Range|Median
1287642|NCT00152516|Secondary|Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with greater than 24 weeks of exposure|Intention to Treat (ITT) Subjects with > 24 Weeks of Exposure and treatment period seizure data|||Percentage of days||Inter-Quartile Range|Median
1287643|NCT00152516|Secondary|Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with up to 24 weeks of exposure|Intention to Treat (ITT) subjects with <= 24 Weeks of Exposure and treatment period seizure data|||Percentage of Days||Inter-Quartile Range|Median
1287644|NCT00152516|Secondary|Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase|"The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.~Note: Rates were reported as percentages."|Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.|||Percentage of Participants|||Number
1287658|NCT00151996|Secondary|Number of Participants With Improvement on Parent Global Assessment (PGA) Scores|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS|||Participants|||Number
1287645|NCT00152516|Secondary|Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.|||Seizures Per Week||Inter-Quartile Range|Median
1287646|NCT00152516|Secondary|Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.|||Seizures Per Week||Inter-Quartile Range|Median
1287647|NCT00152516|Secondary|Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.||Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.|||Seizures Per Week||Inter-Quartile Range|Median
1287648|NCT00152516|Secondary|Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.||Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.|||Seizures Per Week||Inter-Quartile Range|Median
1287649|NCT00152516|Secondary|Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 2 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 248. Of these 248 subjects 227 continued into the maintenance period.|||Percent Reduction in Seizures per Week||Inter-Quartile Range|Median
1287650|NCT00152516|Primary|Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.|||percent reduction in seizures Per Week||Inter-Quartile Range|Median
1287651|NCT00152009|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 5 weeks|ITT|||Units on a scale||Standard Error|Least Squares Mean
1287652|NCT00152009|Secondary|Number of Participants With Improvement in Parent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 5 weeks|ITT|||Participants|||Number
1287653|NCT00152009|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 5 weeks|ITT|||Participants|||Number
1287654|NCT00152009|Secondary|Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks|The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 5 weeks|ITT|||Units on a Scale||Standard Error|Least Squares Mean
1287655|NCT00152009|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 5 weeks|ITT|||Units on a Scale||Standard Error|Least Squares Mean
1287656|NCT00152009|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 5 weeks|Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the baseline and at least one post-randomization primary efficacy measurement.|||Units on a Scale||Standard Error|Least Squares Mean
1287657|NCT00151996|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100 for each. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 6 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1287659|NCT00151996|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks|The Conner's Parent Rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 weeks|FAS|||Units on a Scale||Standard Deviation|Mean
1287660|NCT00151996|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS|||Participants|||Number
1287661|NCT00151996|Primary|Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects with a baseline and at least one post-baseline efficacy measurement.|||Units on a Scale||Standard Deviation|Mean
1287662|NCT00151892|Secondary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score|Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.|6 Months|Intent to treat (ITT) population defined as all randomized subjects who received at least 1 dose of investigational product. Analysis includes patients who completed an SIBDQ questionnaire at 6 months.|||Units on a scale||Standard Deviation|Mean
1287663|NCT00151892|Secondary|Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months|The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.|Baseline and 6 months|PP|||Units on a scale||Standard Deviation|Mean
1287664|NCT00151892|Secondary|Endoscopic Remission of UC With No or Mild Symptoms at 6 Months|Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).|6 Months|PP|||percent of participants|||Number
1287665|NCT00151892|Secondary|Withdrawal Due to Relapse of UC|Relapse is defined as withdrawal from the study due to lack of efficacy.|Over 6 Months|PP|||percent of participants|||Number
1287666|NCT00151892|Primary|Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months|Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].|6 Months|Per Protocol Population (PP) defined as all subjects who either completed the study or withdrew for reasons related to efficacy or AEs and who were deemed to be protocol-compliant.|||percent of participants|||Number
1287667|NCT00151814|Primary|For Olmesartan, the Apparent Oral Volume of Distribution||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||L||Standard Deviation|Mean
1287668|NCT00151814|Primary|For Olmesartan, the Apparent Oral Clearance||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||L/hr||Standard Deviation|Mean
1287669|NCT00151814|Primary|For Olmesartan, the Elimination Half-life of the Drug in Plasma||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||hr||Standard Deviation|Mean
1287670|NCT00151814|Primary|Foe Olmesartan, the Time of Maximum Plasma Concentration||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||hr||Standard Deviation|Mean
1287671|NCT00151814|Primary|For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||ng/mL||Standard Deviation|Mean
1287672|NCT00151814|Primary|For Olmesartan, the Elimination Constant Rate||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||L/hr||Standard Deviation|Mean
1287673|NCT00151814|Primary|For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||ng/mL*hr||Standard Deviation|Mean
1287674|NCT00151814|Primary|For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||ng/mL*hr||Standard Deviation|Mean
1287675|NCT00151775|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)|Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.|Day 0 to week 51 week (end of study)|57=the number of participants who received medication in Period 4|||mm Hg||Standard Deviation|Mean
1290877|NCT00117806|Primary|Competitive Employment-Total Jobs|Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.|12 months||||Total Competitive Employments|||Number
1287676|NCT00151775|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)|Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Day 0 to week 51 (end of study)|Intent to treat population includes participants with at least one visit in Period 4.|||mm Hg||Standard Deviation|Mean
1287677|NCT00151775|Secondary|Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3|Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.|Week 3 (period 3 baseline) to week 5 (end of Period 3)|Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.|||mm Hg||Standard Deviation|Mean
1287678|NCT00151775|Secondary|Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3|Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Week 3 (period 3 baseline) to week 5 (end of Period 3)|Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.|||mm Hg||Standard Deviation|Mean
1287679|NCT00151775|Primary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)|Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Day 0 (baseline) to 3 weeks|The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used|||mm Hg||Standard Deviation|Mean
1287680|NCT00151775|Primary|Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)|The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.|Day 0 to 3 weeks|The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.|||mm Hg||Standard Error|Least Squares Mean
1287681|NCT00151476|Secondary|Rectal or Pouch Adenoma Burden Based on Polyp Counts|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).|Baseline, 6 to 14 months post-baseline, EOS|All subjects; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.|||particpants|||Number
1287682|NCT00151476|Secondary|Duodenal Adenoma Burden as Measured by Spigelman Stage|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.|Baseline, 6 to 14 months post-baseline, End of study (EOS)|All subjects; Spigelman Stage not completed as staging data largely missing.|||participants|||Number
1287683|NCT00151476|Post-Hoc|Duodenal Adenoma Burden as Measured by Polyp Counts|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Post-hoc analysis of duodenal polyp burden in terms of severity categories and based on polyp numbers; Spigelman Stage not completed as staging data largely missing (see: Duodenal adenoma burden as measured by Spigelman Stage)|Baseline, 6 to 14 months post-baseline, End of study (EOS)|All subjects; Spigelman Stage not completed as staging data largely missing; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.|||participants|||Number
1287684|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA|Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had IPAA prior to start of study follow-up); data censored (n=5) for control group subjects (no data).|||months||Full Range|Median
1287685|NCT00151476|Secondary|Time From Post IRA to Time of Conversion From IRA to IPAA|Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.|Up to 15 years prior to baseline|All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data).|||months||Full Range|Median
1287697|NCT00151372|Secondary|Hamilton Depression Rating Scale|The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.|28 Weeks|"Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section."|||points on a scale||Standard Deviation|Mean
1288312|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 40)||Baseline to Week 40|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287686|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of First FAP-related Adverse Event|Time (months): [date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).|Baseline, Up to 60 months post-baseline|All eligible subjects included, except left-censored subjects (had any FAP-related adverse event between the date of most recent FAP-related surgical event performed prior to start of study follow-up, or onset of FAP phenotype (no prior FAP-related surgery), and start of study follow-up.|||months||Full Range|Median
1287687|NCT00151476|Secondary|Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event|Time (months): [date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).|Up to 15 years prior to baseline|All eligible subjects; first FAP-related adverse event (FAP-related cancers, desmoid tumors requiring procedural intervention, hospitalizations, procedural interventions, or death related to FAP) after subject's most recent FAP-related surgical event performed prior to start of study follow-up, onset of FAP phenotype (no prior FAP-related surgery).|||months||Full Range|Median
1287688|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas|Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects included, except left censored subjects (had any excisional or ablational event for rectal, colonic, pouch, or duodenal adenomas between date of most recent FAP-related surgical event performed prior to the start of study follow-up, or onset of FAP phenotype [with no prior FAP-related surgery], and start of study follow-up).|||months||Standard Deviation|Mean
1287689|NCT00151476|Secondary|Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)|Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1] divided by 30.44.|Up to 15 years prior to baseline|All eligible subjects; first excisional or ablational event for rectal adenomas that does not qualify for primary efficacy endpoint; after most recent FAP-related surgical event prior to start of study follow-up or onset of FAP phenotype for subjects with no prior FAP-related surgery.|||months||Standard Deviation|Mean
1287690|NCT00151476|Primary|Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA|Time (months): [date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IPAA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy post IPAA prior to start of study follow-up). No control group subjects (n=7) had a post-IPAA polypectomy (no data).|||months||Standard Deviation|Mean
1287691|NCT00151476|Primary|Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA|Time (months): [date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient’s most recent FAP-related surgery date=index date for Matched Control.|Up to 15 years prior to baseline|All eligible subjects with IPAA performed prior to start of study follow-up included and with first excisional polypectomy of a rectal polyp post IPAA. No control group subjects (n=7) had a post-IPAA polypectomy (no data).|||months||Standard Deviation|Mean
1287692|NCT00151476|Primary|Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA|Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy of rectal polyp post IRA prior to start of study follow-up). No control group subjects (n=3) had a post-IRA polypectomy (no data).|||months||Full Range|Median
1287693|NCT00151476|Primary|Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA|Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient’s most recent FAP-related surgery date=index date for Matched Control.|Up to 8 years prior to baseline|All eligible subjects with IRA performed prior to start of study follow-up; first excisional polypectomy of rectal polyp post IRA. Polyp size unavailable for many subjects; not considered in analysis.|||months||Standard Deviation|Mean
1287694|NCT00151411|Secondary|Change in Insulin Sensitivity Index After 6 Months of Treatment||baseline and 6 months||||index||95% Confidence Interval|Least Squares Mean
1287695|NCT00151411|Secondary|Ovulation Rate|Count of ovulations per subject during the treatment period.|6 months|A total of 76 patients with daily urine collections.|||Participants|||Count of Participants
1287696|NCT00151411|Primary|Change in Testosterone After 6 Months of Treatment||baseline and 6 months||||ng/dL||95% Confidence Interval|Least Squares Mean
1287698|NCT00151372|Primary|Composite Antidepressant Score Scale (CAD)|The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.|28 Weeks|"Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section."|||Participants|||Number
1287699|NCT00151320|Primary|ORR|Overall Response Rate|6 cycles (18 weeks)||||percentage of patients|||Number
1287700|NCT00151281|Secondary|The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment|"QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points.~ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below."|baseline, every 2 months until Month 6, and every 6 months until disease progression||||FACT-G score||Full Range|Mean
1287701|NCT00151281|Secondary|Dynamic Levels of Plasma VEGF|Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1.|38 months|subjects with evaluable VEGF level at baseline|||pg/mL||Full Range|Median
1287702|NCT00151281|Secondary|Asses the Toxicity Profiles|Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.|38 months|patients treated with study drug|||Participants|||Count of Participants
1287703|NCT00151281|Primary|Overall Survival and Progression Free Survival|measured by overall Response Rate (ORR), which includes Complete response and partial response.|38 months|Twenty-five patients were enrolled, and 22 of those patients were assessable for response (3 patients were enrolled but received no therapy)|||percentage of patients|||Number
1287704|NCT00150969|Secondary|Difference in Number of New Clinical Fractures by Treatment Arm.|these included fragility fractures|up to 48 months||||events|||Number
1287705|NCT00150969|Secondary|Difference in Number of New Cancers by Treatment Arm.||up to 48 months||||events|||Number
1287706|NCT00150969|Secondary|Difference in Serious Adverse Events|These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.|up to 48 months||||events|||Number
1287707|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months||||percentage change in BMD||Standard Deviation|Mean
1287708|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months||||percentage change in BMD||Standard Deviation|Mean
1287709|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months||||percentage change in BMD||Standard Deviation|Mean
1287710|NCT00150969|Primary|Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.|||percentage change in BMD||Standard Deviation|Mean
1287711|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months||||percentage change in BMD||Standard Deviation|Mean
1287712|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin|measured by osteocalcin hydroxyapatite binding assay|0 to 24 months||||percentage of undercarboxylated OC||Standard Deviation|Mean
1287713|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)|measured by CTX Elisa assay on elecsys platform|0-24 months||||ng/ml||Standard Deviation|Mean
1287714|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker|measured by osteocalcin on elecsys platform|0-24 months||||ng/ml||Standard Deviation|Mean
1287715|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.|||percentage change in BMD||Standard Deviation|Mean
1287716|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.|||percentage change in BMD||Standard Deviation|Mean
1287717|NCT00150969|Primary|Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.|||percentage change in BMD||Standard Deviation|Mean
1287718|NCT00150813|Primary|Percentage Participants With Treatment Emergent Adverse Events|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks|Safety Set|||percentage of participants|||Number
1287719|NCT00150800|Secondary|Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period|A responder is defined as a subject with a higher than or equal to (>=) 50 % change in seizure frequency from Baseline period of the previous study.|From Baseline of the previous study to the Evaluation Period (up to 11 years)|The Partial Onset Seizures (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.|||percentage of participants|||Number
1287720|NCT00150800|Secondary|Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period|"The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:~(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines."|From Baseline of the previous study to the Evaluation Period (up to 11 years)|The Partial Onset Seizures (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.|||percent change||Inter-Quartile Range|Median
1287721|NCT00150800|Secondary|Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period|"Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].~A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28."|From Baseline of the previous study to the Evaluation Period (up to 11 years)|The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.|||Seizures per 28 days||Inter-Quartile Range|Median
1287722|NCT00150800|Primary|Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period|A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.|Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1287723|NCT00150800|Primary|Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period|Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.|Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1287724|NCT00150800|Primary|Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period|Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.|Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1287725|NCT00150618|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 6 weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
1287726|NCT00150618|Secondary|Number of Participants With Improvement in Parent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|ITT|||Participants|||Number
1287727|NCT00150618|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|ITT|||Participants|||Number
1287728|NCT00150618|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 weeks|ITT|||Units on a Scale||Standard Error|Least Squares Mean
1287729|NCT00150618|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the Baseline and at least one post-randomization primary efficacy measurement.|||Units on a Scale||Standard Error|Least Squares Mean
1287730|NCT00150592|Secondary|Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks|The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.|Baseline and 6 weeks|FAS|||Units on a Scale||Standard Deviation|Mean
1287731|NCT00150592|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline and 6 weeks|FAS|||Units on a Scale||Standard Deviation|Mean
1287732|NCT00150592|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS|||Participants|||Number
1287803|NCT00149669|Primary|Percentage of Urine Samples Positive for Naltrexone|The number of urine samples positive for naltrexone divided by the total number of urine samples times 100.|6 months|intent to treat|||Percentage of Urine Samples||Full Range|Mean
1287733|NCT00150592|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects who received at least one dose of investigational product.|||Units on a Scale||Standard Deviation|Mean
1287734|NCT00150592|Secondary|Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks|"The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue tokens in various displayed boxes and use the tokens to fill a column on the right side of the screen. Subjects can only find tokens in new boxes, therefore they must remember where previous tokens were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance."|Baseline and 6 weeks|PP|||Units on a scale||Standard Deviation|Mean
1287735|NCT00150592|Secondary|Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years|The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.|Baseline and 6 weeks|PP|||Units on a scale||Standard Deviation|Mean
1287736|NCT00150592|Secondary|Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years|The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.|Baseline and 6 weeks|PP|||Units on a scale||Standard Deviation|Mean
1287737|NCT00150592|Primary|Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks|Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.|Baseline and 6 weeks|Per protocol (PP) defined as all subjects who completed the study and were deemed to be protocol-compliant.|||msec||Standard Deviation|Mean
1287738|NCT00150462|Primary|Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. AUCinf was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2–8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.|||ng*minute/mL||Standard Deviation|Mean
1287739|NCT00150462|Primary|Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. AUClast was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2–8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.|||ng*minute/mL||Standard Deviation|Mean
1287740|NCT00150462|Primary|Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. Tmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.|||minutes||Standard Deviation|Mean
1287741|NCT00150462|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable population|||days||Full Range|Median
1287742|NCT00150462|Secondary|Time to Progression|"Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment.~Median time to progression was calculated using the Kaplan-Meier method."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable population|||days||Full Range|Median
1287743|NCT00150462|Secondary|Duration of Response|"Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment.~Median duration of response was calculated using the Kaplan-Meier method."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable participants with an objective response|||days||Full Range|Median
1287804|NCT00149643|Secondary|Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.|Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.|12 Weeks||||Number of DSM-IV criterion||Standard Deviation|Mean
1287744|NCT00150462|Secondary|Best Clinical Response to Treatment|"Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin’s Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström’s Macroglobulinemia. The disease response criteria for Hodgkin’s Lymphoma are defined as follows:~Complete response: total resolution of measurable disease parameters.~Partial response: a ≥ 50% resolution without the appearance of new disease.~Stable disease: between < 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease.~Progressive disease: an increase of > 25% in measurable disease parameters.~Best clinical response is the best response observed from the start of study treatment until disease progression or death."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.|||participants|||Number
1287745|NCT00150462|Primary|Maximum Observed Plasma Concentration of Carfilzomib (Cmax)||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.|||ng/mL||Standard Deviation|Mean
1287746|NCT00150462|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|"A DLT was defined as any of the following occurring in the first 28 days of study participation:~Nonhematologic:~> Grade 2 neuropathy with pain~≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea)~≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy~Hematologic:~Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support~Febrile neutropenia (ANC < 1.0 × 10ˆ9/L with a fever ≥ 38.3°C)~Grade 4 thrombocytopenia (platelets < 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding.~Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0."|28 days|Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib|||participants|||Number
1287747|NCT00150345|Secondary|Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned||Day 28|MITT; data not summarized as planned; data insufficient for analysis due to missing data.|||participants|||Number
1287748|NCT00150345|Secondary|Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned||Day 28|MITT|||participants|||Number
1287749|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died)|Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Died). A participant must have died before Day 28 (final visit).|Day 2 through Day 28|"MITT; participants who completed the study and had a non-missing value for percent of positive panfungal PCR: no participants met this criteria within the category Died."|||percent of positive PCR assessments|||Number
1287750|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive)|Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Alive). A participant must be evaluable until Day 28 (final visit).|Day 2 through Day 28|"MITT; participants who completed the study and had a non-missing value for percent of positive panfungal PCR. N=number of participants for category Alive."|||percent of positive PCR assessments||Standard Deviation|Mean
1287751|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287752|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No)|Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287753|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence|Percent of positive panfungal PCR assessments during treatment phase of study in association with time to defervescence. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with time to defervescence was not summarized as planned.|||percent of positive PCR assessments||Standard Deviation|Mean
1287754|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
1291316|NCT00114244|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier by arm.|From first day of treatment to time of death due to any cause, assessed up to 6 months||||Months||95% Confidence Interval|Median
1287755|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
1287756|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 5 (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 5 (96 hours through 120 hours after start of study treatment)|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287757|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28|Percent of positive panfungal PCR assessments during treatment phase of study in association with proven or probable IFI (complete cases) between Day 2 and Day 28 (Yes or No). Complete case analysis: participant must be evaluable until Day 28 (final visit) or have developed a proven or probable IFI by the final visit. Participant considered evaluable until Day 28 if participant completed the study and completed an assessment of IFI at Day 28 or final visit. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287758|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
1287759|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified|Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287760|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With C-reactive Protein Level >1.25 Times the Upper Limit of Normal (x ULN)|Percent of positive panfungal PCR assessments during treatment phase of study in association with c-reactive protein level (measured in milligrams per liter [mg/L]) >1.25 x ULN (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with c-reactive protein level was not summarized as planned.|||percent of positive PCR assessments||Standard Deviation|Mean
1287761|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL|Percent of positive panfungal PCR assessments during treatment phase of study in association with neutrophil count >500 uL (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287762|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole|Percent positive panfungal PCR assessments during treatment phase of study in association with use of concomitant (prophylaxis) fluconazole (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287763|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants|Percent of positive panfungal PCR assessments during treatment phase of study in association with allogeneic bone marrow transplant or allogeneic peripheral stem cell transplant (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287764|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease|Percent of positive panfungal PCR assessments during treatment phase of study in association with primary underlying neoplastic disease. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287765|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender|Percent of positive panfungal PCR assessments during treatment phase of study in association with gender (Female or Male). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
1287766|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age|Percent of positive panfungal PCR assessments during treatment phase of study in association with age for participants who completed the study and have a non-missing value for percent of positive panfungal PCR.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with age was not summarized as planned.|||percent of positive PCR assessments||Standard Deviation|Mean
1287767|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No)|Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=No). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
1287768|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=Yes). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
1287769|NCT00150345|Secondary|Time to Negative Panfungal Polymerase Chain Reaction (PCR)|Time (in days) from start of study medication to negative panfungal PCR; assessed for participants whose most recent panfungal PCR result prior to start of study medication was positive. Defined as negative if at least 2 successive and all following panfungal PCR assessments from start of study medication until 24 hours after end of treatment are negative. Measured as first quartile of time (point in time measurement; no median or measure of dispersion calculated); median time was not estimable for deferred voriconazole treatment group.|Day 2 through Day 28|MITT; N=number of participants whose most recent panfungal PCR result prior to start of study medication was positive.|||days|||Number
1287770|NCT00150345|Secondary|Number of Participants That Died on or Before Day 28 (Mortality)|Number of participants that died on or before Day 28 after start of study treatment. A participant must be evaluable until Day 28 (final visit) or have died before the final visit.|Day 2 through Day 28|MITT; N=number of participants evaluable until Day 28 (final visit) or died before the final visit.|||participants|||Number
1287771|NCT00150345|Secondary|Number of Participants Per Reason for Lack of Defervescence||Day 2 through Day 28|MITT|||participants|||Number
1287772|NCT00150345|Secondary|Time to Continuous Defervescence|Time (in days) from start of study medication to continuous defervescence. Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours.|Day 2 through Day 28|MITT|||days||95% Confidence Interval|Median
1287773|NCT00150345|Secondary|Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment)|Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participant's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).|Day 9 (192 hours through 216 hours after start of study treatment)|MITT|||particpants|||Number
1287774|NCT00150345|Secondary|Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment)|Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participants's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).|Day 5 (96 hours through 120 hours after start of study treatment)|MITT|||participants|||Number
1287775|NCT00150345|Primary|Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis|Number of participants with proven (deep tissue infection, fungemia, or endemic fungal infections) or probable IFI (at least 1 host criterion [fever, body temperature <36 or >38 degrees Celsius, graft-versus-host disease, use of corticosteroids]; and 1 microbiological criterion [fungal or yeasts]; or clinical criteria [abnormal site consistent with infection]) as defined by European Organization for Research and Treatment of Cancer Mycosis Study Group (EORTC/MSG) criteria. Complete case analysis: must be evaluable until Day 28 or had developed a proven or probable IFI by the final visit.|Day 2 through Day 28|Modified Intent-to-Treat population (MITT): participants in ITT population (at least 1 dose of study treatment) with valid post-baseline proven or probable IFI, did not have fungemia or other IFI at screening or randomization, no antipyretic analgesics on Day 5 (or Day 9 of open-label voriconazole). N=number of complete case evaluable participants.|||participants|||Number
1287776|NCT00150176|Secondary|Time to Early Discontinuation for Any Reason|The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).|time of discontinuation up to Day 182 (double blind phase)|Intent to treat (ITT) population, additionally excluding subjects not treated and excluding subjects with past enrollment in an asenapine trial.|||participants|||Number
1288320|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response defined as Viral Load<50 copies/mL|Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1287777|NCT00150176|Primary|Time to Relapse or an Impending Relapse|"A relapse or impending relapse was declared if a subject meets 1 of 3 symptomatic relapse criteria which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary."|time of first relapse up to Day 182 (double blind phase)|ITT population, excluding subjects not treated and w/ past enrollment in an asenapine trial. As trial progressed & subjects discont'd for various reasons, subjects at risk for relapse decreased from 190 each arm (Day 1) to 70 at risk in placebo arm and 135 subjects in asenapine arm (Day 182). Those relapsing >3 days after last dose also excluded.|||relapses|||Number
1287778|NCT00149994|Primary|Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.|A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months.|Month 3|Intention to treat (ITT) population.|||Percentage of Participants|||Number
1287779|NCT00149890|Secondary|Percentage of Participants With Treatment Failure Within Three and Six Months|To evaluate the proportion of patients with treatment failure treated with a therapy consisting of intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids within three and six months.|3 and 6 months|Intention to treat population|||Percentage of participants||95% Confidence Interval|Number
1287780|NCT00149890|Secondary|Time of Onset of a First Biopsy Proven Acute Rejection|Biopsied Tissue shows rejection at onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever and hypertension|6 months|safety/Intent to Treat (ITT) population|||Months||95% Confidence Interval|Median
1287781|NCT00149890|Secondary|Number of Participants With Bacterial, Viral and Fungal Infections During Six Months|To evaluate the safety of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the episodes of bacterial, viral and fungal infections during six months.|6 months|Safety Population|||Participants|||Number
1287782|NCT00149890|Secondary|Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation|Graft loss is defined as being listed for a re-transplantation.|3 months and 6 months|safety/Intent to Treat (ITT) population|||Percentage of participants|||Number
1287783|NCT00149890|Secondary|Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months|To evaluate the efficacy of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the incidence of steroid resistant rejection episodes within three and six months.|3 and 6 months|safety/Intent to Treat (ITT) population|||Participants|||Number
1287784|NCT00149890|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months|At biopsy of transplanted tissue sample, acute rejection has an onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever, and hypertension.|3 months|safety/Intent to Treat (ITT) population|||Participants|||Number
1287785|NCT00149890|Primary|Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation|Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.|3 months after treatment|safety/Intent to Treat (ITT) population|||Participants|||Number
1287786|NCT00149838|Primary|Depression Remission, as Measured by the Hamilton Rating Scale for Depression|The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8|Measured at the end of Phases 1, 2, and 3|Remission|||number of remitted patients|||Number
1287787|NCT00149825|Secondary|Remission of Insomnia|Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.|After 12 weeks or at the last available time point|Included in the analysis were all participants who attended at least one post randomization visit.|||percent|||Number
1287788|NCT00149825|Primary|Remission of Depression (%)|"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.~The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.~The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains)."|After 12 weeks or at the last available time point||||percent of participants|||Number
1287805|NCT00149643|Primary|Depression Symptoms at Week 12|Average of Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10 and 12. The BDI is a subject reported measure that has a minimim score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scare (63). Each DSM-IV criteron asses a different depressive symptom.|12 Weeks||||BDI Total||Standard Deviation|Mean
1287806|NCT00149643|Primary|Days Per Week of Cannabis Use.|The number days out of the last seven days that cannabis was used.|12 Weeks||||Days of cannabis use per week||Standard Deviation|Mean
1287789|NCT00149799|Secondary|Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)|Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction.|Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)|28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.|||Percentage score||Standard Deviation|Mean
1287790|NCT00149799|Secondary|Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)|Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning.|Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)|28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.|||units on a scale||Standard Deviation|Mean
1287791|NCT00149799|Secondary|Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)|Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression.|Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40|A total of 58 participants who had responded to open-label Escitalopram (phase 1) were randomized to receive either Escitalopram (n=28) or placebo (n=30) in the double-blind relapse prevent trial (phase 2). Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.|||units on a scale||Standard Deviation|Mean
1287792|NCT00149799|Secondary|Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)|We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.|Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14||||percentage of subjects who responded|||Number
1287793|NCT00149799|Primary|Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)|We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.|Phase II: Biweekly for six months after randomization|Intent-to-treat analysis of all 58 patients randomized to Phase II.|||percentage of subjects who relapsed|||Number
1287794|NCT00149747|Secondary|Peak Exercise Oxygen Consumption|Peak oxygen consumption measured during symptom limited treadmill exercise stress test|12 months||||mL of 02 per Kg per minute||Standard Deviation|Mean
1287795|NCT00149747|Secondary|Sleep Disturbances|"Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance.~All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances."|12 months|Intent to treat|||units on a scale||Standard Deviation|Mean
1287796|NCT00149747|Primary|% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline|Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).|baseline, 12 months|Intent to Treat|||percentage of sleep time||Standard Deviation|Mean
1287797|NCT00149669|Other Pre-specified|Cocaine Positive Urine Samples|The number of urine samples that were positive for cocaine|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.||||||
1287798|NCT00149669|Other Pre-specified|Percentage of Urine/Breath Samples Negative for Other Drugs of Abuse|The percentage of urine and breath samples that are negative for other drugs of abuse|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.||||||
1287799|NCT00149669|Other Pre-specified|Cost Benefit Analysis|The costs and economic benefits of the intervention|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.||||||
1287800|NCT00149669|Other Pre-specified|HIV Risk Behaviors|Behaviors that place participants at risk for acquiring or transmitting HIV|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.||||||
1287801|NCT00149669|Secondary|Percentage of Urine Samples Negative for Opiates|The number of urine samples negative for opiates divided by the total number of urine samples times 100.|6 months|intent to treat|||Percentage of Urine Samples||Full Range|Mean
1287802|NCT00149669|Secondary|Percentage of Urine Samples Negative for Cocaine|the number of urine samples that were negative for cocaine divided by the total number of urine samples) x 100|6 months|intent to treat|||Percentage of Urine Samples||Full Range|Mean
1287807|NCT00149630|Secondary|Retention by Treatment Condition.|Treatment retention for full 12 weeks of study.|12 weeks|74 cocaine and opioid-codependent(DSM-V)subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250 mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduced DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.|||% of subjects who complete 12 wks study|||Number
1287808|NCT00149630|Primary|Urine Toxicology for Cocaine.||Thrice weekly, baseline through week 14.|74 cocaine and opioid-codependent (DSM-V) subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduces DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.|||% cocaine + urines over 2 week blocks||Standard Error|Mean
1287809|NCT00149396|Secondary|Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)|Median change from baseline of tumor necrosis factor (TNF-alpha) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)|Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)||||pg/mL||Full Range|Median
1287810|NCT00149396|Secondary|Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)|Median change from baseline of Interleukin-6 (IL-6) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)|Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)||||pg/mL||Full Range|Median
1287811|NCT00149396|Secondary|Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)|Median change from baseline of Interferon (INF) gamma 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)|Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)||||pg/mL||Full Range|Median
1287812|NCT00149396|Primary|Clinical Laboratory Safety - Coagulation|Number of patients with post-baseline clinically significant laboratory coagulation abnormalities by NV1020 dose cohort|Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment||||participants|||Number
1287813|NCT00149396|Primary|Clinical Laboratory Safety - Chemistry|Number of patients with post-baseline clinically significant laboratory chemistry abnormalities by NV1020 dose cohort|Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment||||participants|||Number
1287814|NCT00149396|Primary|Clinical Laboratory Safety - Hematology|Number of patients with clinically significant hematology laboratory abnormalities by NV1020 dose cohort (Post baseline)|Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment||||participants|||Number
1287815|NCT00149396|Primary|NV1020 Pharmacokinetics - Presence of NV1020 in Body Fluids/Skin|Number of patients with NV1020 detected in saliva, skin, and/or mucosal surfaces; Analysis by polymerase chain reaction (PCR)|Daily for 2 weeks after the first and last NV1020 infusions||||participants|||Number
1287816|NCT00149396|Secondary|Time to Disease Progression; Survival Time|Progression assessed from CT and PET measurements and is determined as an increase of greater than or equal to 25% in the sum of the products of perpendicular diameters of all tumors, or the appearance of any new lesion.|Progression: Chemo visit 1, FU1 (1 week post treatment), FU2 (+6M), FU3 (+9M), FU4 (+12M); Survival: death of patient||||months||95% Confidence Interval|Median
1287817|NCT00149396|Secondary|Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay|Mean change from baseline in NV1020 neutralizing antibody titer by dose cohort|Screening, Chemo Visit 1, Follow-up Visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)||||antibody titer||Standard Deviation|Mean
1287818|NCT00149396|Secondary|Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment|Maximum percentage changes in tumor diameter after administration of NV1020 followed by chemotherapy as measured by CT scan and Modified Response Evaluation Criteria in Solid Tumors (RECIST) assessment|Screening (baseline), Chemo visit 1, Follow-up visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)||||percentage|||Number
1287819|NCT00149396|Secondary|Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy||Screening (baseline), Chemo visit 1, Chemo visit 2, Follow-up Visit 1 (1 week after end of treatment), Follow-up Visit 2 (+6M), Follow-up Visit 3 (+9M), Follow-up Visit 4 (+12M)|"Number of participants analyzed decreases through the follow-up visits. Thus the Number of Participants Analyzed indicated here refer to the number at baseline."|||ng/mL||Standard Deviation|Mean
1287820|NCT00149396|Primary|Incidence of Adverse Events and Dose Limiting Adverse Events|Incidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term|From start of treatment through 12 months after completion of treatment||||percentage of participants|||Number
1287821|NCT00149227|Secondary|Uncontrolled Blood Pressure, Etc.||five years|||||||
1287822|NCT00149227|Secondary|New Onset or Worsening of Diabetes Mellitus or IGT|"Diabetes mellitus was defined as fasting plasma glucose >=126 mg/dl, causal blood glucose >= 200 mg /dl, HbA1C >= 6.5%, and/or plasma glucose 2hr after 75g glucose load >= 200 mg/dl. The first of these events, new onset diabetes or worsening diabetes following IGT, occurring in a specific patient was classified as an event to be counted in the secondary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level."|five years||||event number|||Number
1287823|NCT00149227|Secondary|New Onset or Worsening of Arrhythmias||five years|||||||
1287824|NCT00149227|Secondary|Worsening of Cardiac Function||five years|||||||
1287825|NCT00149227|Secondary|All Cause Mortality||five years||||patients|||Number
1287836|NCT00149214|Secondary|Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery|Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.|surgery after eight 21-day cycles of chemotherapy|"Participants meeting the following criteria qualify for pathological tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy~Specimen for evaluation of pathological response obtained upon surgery~Treatment with at least one dose of study drug of the assigned study regimen."|||participants|||Number
1287826|NCT00149227|Primary|Transition to Dialysis, Doubling of Plasma Cr Levels|"The first of any events, transition to dialysis or doubling of plasma Cr levels compared to the entry, occurring in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level."|five years||||event number|||Number
1287827|NCT00149227|Primary|New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans|Arteriosclerosis obliterans (ASO) event was diagnosed with symptoms and CT / MRI imaging. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
1287828|NCT00149227|Primary|New Onset of Acute Dissecting Aneurysm of the Aorta|Dissecting aneurysm of the aorta required hospitalization and was diagnosed by imaging technique, CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
1287829|NCT00149227|Primary|Operation of PCI or Bypass Operation||five years|||||||
1287830|NCT00149227|Primary|Hospitalization Due to the New Onset, Occurrence or Worsening of Angina Pectoris and Additional Concomitant Use of Other Anti-anginal Agents or Increase of Dosage|Angina pectoris event required hospitalization and was diagnosed by both ECG changes corresponding with chest symptoms and coronary angiography showing 75% stenosis according to AHA/ACC guidelines. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
1287831|NCT00149227|Primary|Hospitalization Due to the New Onset, Recurrence or Worsening of Heart Failure and Additional Concomitant Use of Other Anti-heart Failure Agents or Increase of Dosage|Heart failure event was defined as requiring hospitalization and clinical symptoms together with left ventricular dysfunction by echocardiography according to the guidelines of the AHA/ACC. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
1287832|NCT00149227|Primary|New Onset or Recurrence of Acute Myocardial Infarction|Acute myocardial infarction was diagnosed with hospitalization, ECG- change, and biomarkers for myocardial infarction. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
1287833|NCT00149227|Primary|New Onset or Recurrence of Transient Ischemic Attack|Transient ischemic attack (TIA) was defined as hospitalization with sudden onset of neurological deficit persisting for less than 24 hrs, and without abnormal findings using by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
1287834|NCT00149227|Primary|New Onset or Recurrence of Stroke|Stroke events included brain hemorrhage, infarction, and TIA. They required hospitalization with neurological symptoms and were diagnosed by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|Analyses were made by the independent Statistical Analysis Organization based on the intention-to-treat principle.|||event number|||Number
1287835|NCT00149214|Secondary|Disease-free Survival|Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.|baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)|All randomized participants. In the Pemetrexed plus Doxorubicin, Followed by Docetaxel arm, 99 participants were censored. In the Cyclophosphamide plus Doxorubicin, Followed by Docetaxel arm, 94 participants were censored.|||months||95% Confidence Interval|Median
1288313|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 32)||Baseline to Week 32|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287837|NCT00149214|Secondary|Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy|The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.|Cycles 5-8 (21-day cycles)|"Participants meeting following criteria qualify for clinical tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy up to surgery~Presence of measurable disease as defined by RECIST.~Treatment with at least one dose of study drug of assigned study regimen."|||participants|||Number
1287838|NCT00149214|Secondary|Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy|The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.|Cycles 1-4 (21-day cycles)|"Participants meeting following criteria qualify for clinical tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy up to surgery~Presence of measurable disease as defined by RECIST.~Treatment with at least one dose of study drug of assigned study regimen."|||participants|||Number
1287839|NCT00149214|Primary|Number of Participants With a Pathological Complete Response|pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy|surgery after eight 21-day cycles of chemotherapy|"Participants meeting the following criteria qualify for pathological tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy~Specimen for evaluation of pathological response obtained upon surgery~Treatment with at least one dose of study drug of the assigned study regimen."|||participants|||Number
1287840|NCT00148954|Secondary|Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode||Time of event|||||||
1287841|NCT00148954|Secondary|Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)||Time of event|||||||
1287842|NCT00148954|Secondary|Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)||Time of event|||||||
1287843|NCT00148954|Primary|Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit|An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.|From date of pre-discharge until a minimum of 12 months follow-up until study closure||||Participants|||Number
1287844|NCT00148798|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|Safety Population|||participants|||Number
1287845|NCT00148798|Secondary|A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations|Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.|Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.||||ug/mL||Standard Deviation|Mean
1287846|NCT00148798|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.|at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 280/275; cycle 3 185/153; 6 month 101/97|||scores on a scale||Standard Error|Least Squares Mean
1287847|NCT00148798|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 278/274; cycle 3 184/153; 6 month 102/96|||scores on a scale||Standard Error|Least Squares Mean
1287848|NCT00148798|Secondary|Disease Control Rate|The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT|||percentage of participants||95% Confidence Interval|Number
1287849|NCT00148798|Secondary|Best Overall Response Rate|The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007||||percentage of participants||95% Confidence Interval|Number
1287850|NCT00148798|Secondary|Progression-free Survival Time|"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT|||months||95% Confidence Interval|Median
1287851|NCT00148798|Primary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT|||months||95% Confidence Interval|Median
1287852|NCT00148759|Primary|24-hr LPV AUC|Steady state(2 weeks after therapy change)|24 hours||||ng*hr/mL||Inter-Quartile Range|Geometric Mean
1287853|NCT00148759|Secondary|24-hr LPV Cmax|LPV Cmax at Steady State|24 hours||||ng/mL||Inter-Quartile Range|Geometric Mean
1287854|NCT00148733|Secondary|Folate, Cobalamin and Vitamin D Status of the Enrolled Children|And whether or not these vitamins predict treatment failure and duration of illness.|14 days||2019-12-31|12/2019||||
1287855|NCT00148733|Secondary|Will Presence of a RNA Virus Modify the Effect of Zinc|We will compare the efficacy of zinc according to virus detected in nasopharyngeal secretions|14 days||2019-12-31|12/2019||||
1287856|NCT00148733|Secondary|The Efficacy of Zinc in Malnourished and Non-malnourished Children|We will compare the efficacy of zinc in those that are stunted, wasted or underweight with those who are not.|Within 2 weeks after enrollment||2019-12-31|12/2019||||
1287857|NCT00148733|Secondary|The Efficacy of Zinc According to Breast Feeding Status and in Different Age Categories|We will measure to what extent breastfeeding status modifies the effect of zinc on pneumonia|Within 2 weeks after enrollment||2019-12-31|12/2019||||
1287858|NCT00148733|Secondary|Effect Modifiers for the Effect of Zinc Given During Pneumonia|We will also measure of there are factors at baseline that modifies the effect of zinc. Whether the following are modifiers for the above-mentioned effect of zinc given during pneumonia: i.severe inflammation, reflected in: high fever and/or elevated plasma C-reactive protein (CRP) concentration|Within 2 weeks after enrollment||2019-12-31|12/2019||||
1287859|NCT00148733|Primary|Adverse Effects|Vomiting, regurgitation, pain in abdomen for 15 minutes after zinc or placebo administration.|14 days||2019-12-31|12/2019||||
1287860|NCT00148733|Primary|Difference in Growth and Thymic Size Between the Treatment Groups Measured at Three and Six Months After the Zinc Supplementation|Thymus size will be measured using ultrasonography and compared between the two groups. at two occasions 2.5 and 6 months after end of supplementation|six months||2019-12-31|12/2019||||
1287861|NCT00148733|Primary|Active and Passive Morbidity Surveillance for Six Months After the 14-day Supplementation Period is Completed|We will measure to what extent short term zinc administration has an impact on growth and morbidity for up to 6 months after end of supplementation|six months||2019-12-31|12/2019||||
1287862|NCT00148733|Primary|Non-injury Clinic Visits and Hospital Admissions After Treatment Has Been Initiated|We will measure to what extent the intervention can reduce the number of severe events.|Within 2 weeks after enrollment||2018-12-31|12/2018||||
1287863|NCT00148733|Primary|Risk of Treatment Failure.|Enrolled children will be followed and given zinc or placebo for 14 days. We will compare the proportion with treatment failure (i.e. lack of improvement within 3 days) between the two groups|Within 2 weeks after enrollment||||participants|||Number
1287864|NCT00148668|Primary|Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer|Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery|12 weeks|Please Note that in Arm 2, the number of participants analyzed is equal to 39, which differs from the Number of Participants reported in the baseline measure (N= 40) because one participant withdrew her consent, so was not evaluable.|||percentage of participants|||Number
1287865|NCT00148343|Secondary|Gait Speed||baseline, 12, 24 and 36 weeks||||meters/sec||Standard Deviation|Mean
1287866|NCT00148343|Secondary|Stroke-Specific Quality of Life Scale (SS-QOL)|"The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales.~Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245."|Weeks 0, 12, 24, 36||||Summary Score||Standard Deviation|Mean
1287867|NCT00148343|Secondary|Modified Emory Functional Ambulation Profile(mEFAP)|The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the “timed up-and-go” test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds.|Weeks 0, 12, 24, 36||||seconds||Standard Deviation|Mean
1287868|NCT00148343|Secondary|Steps Per Minute|The number of steps taken by participants in one minute|Weeks 0, 12, 24, 36||||Steps/Min||Standard Deviation|Mean
1287869|NCT00148343|Primary|Fugl-Meyer Motor Assessment (FMA)|Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).|Weeks 0, 12, 24, 36|For intent-to-treat analysis, all participants who were randomized and completed baseline assessments were included in the analysis|||units on a scale||Standard Deviation|Mean
1287883|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 3 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 3 months. Participants were seen 3 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|3 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
1288314|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 24)||Baseline to Week 24|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287870|NCT00148317|Secondary|Progression Free Survival|"Response was assessed using IMWG guidelines, which for progressive disease are as follows:~Increase of > 25% from lowest response value in any one or more of the following:~Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*~Urine M-component and/or (the absolute increase must be > 200 mg/24 h)~Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL~Bone marrow plasma cell percentage; the absolute percentage must be > 10%~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder IF starting M protein component is > 5g/dL, then absolute increase of 1g is sufficient for progression."|Date of progression, assessed from start of trial to Final data cut off date (15 April 2011)||||months||Full Range|Median
1287871|NCT00148317|Secondary|Yield of CD34+ Stem Cells|This is the yield of CD34+ stem cells collection after high dose cyclophosphamide.|Occurred after mobilization, and prior to Stem cell transplant; a 7 day limit was imposed on stem cell collection||||10^6 cells/kg||Full Range|Median
1287872|NCT00148317|Primary|Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)|Myeloma response criteria developed by Bladé et al. was used to categorize response.|Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization|All 38 patients were treated with DoVeD consolidation therapy (Vel + DEX with or without DOXIL). Of the 38 patients enrolled, 27 proceeded to mobilization (11 did not undergo mobilization). Responses were assessed prior to mobilization (post DoVED), and again after mobilization, to see if mobilization improved patient response.|||participants|||Number
1287873|NCT00148122|Secondary|Probability of Progression Free Survival|The estimated 1 year progression free survival. Progression was defined, using RECIST (Response Evaluation Criteria In Solid Tumors Criteria), as a 20% increase in the sum of the longest diameter of target lesions, the development of any new lesion, or the significant clinical deterioration related to the progression of patient's disease. The probability of progression-free survival was presented in a Kaplan-Meier curve to illustrate the distribution of progression time. The median time to progression was determined with a 95% CI (Confidence Interval).|1 year post treatment|40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.|||percentage of patients||95% Confidence Interval|Number
1287874|NCT00148122|Secondary|Frequency of Grade III/IV Toxicities Experienced by Participants|The frequency of grade 3 and grade 4 adverse events experienced by all treated participants.|30 days post treatment|40 patients were enrolled. 2 patients withdrew consent, therefore only 38 were included in the toxicity analysis.|||participants|||Number
1287875|NCT00148122|Primary|Overall Response Rate at 4 Months|Disease was assessed by radiologic imaging and RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|4 months|40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.|||percentage of participants|||Number
1287876|NCT00148109|Secondary|Overall Survival|Time of cetuximab administration to clinically documented death assessed for four months|months||||months||95% Confidence Interval|Median
1287877|NCT00148109|Secondary|Progression Free Survival.|Time of cetuximab administration to clinically documented progression of disease or death assessed for four months|survival||||months||95% Confidence Interval|Median
1287878|NCT00148109|Primary|Number of Patients With Sarcoma Who Are Tumor Progression Free and Alive at Four Months From Start of Treatment With Single-agent Cetuximab.|Time of cetuximab administration to clinically documented progression of disease or death assessed for four months after starting cetuximab therapy|4 months|per protocol all patients that received drug were evaluated for the primary endpoint|||participants|||Number
1287879|NCT00147966|Primary|American College of Rheumatology (ACR) 20 at Week 12|ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).|0 and 12 weeks||||participants|||Number
1287880|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 6 Weeks|Bone trabeculation through the bone lesion compared at 6 weeks were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|6 weeks|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
1287881|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 6 Weeks|Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 weeks. Participants were seen 6 week follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|6 weeks|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
1287882|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 3 Months|Bone trabeculation through the bone lesion compared at 3 months were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|3 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
1288315|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 16)||Baseline to Week 16|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287884|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 6 Months|Bone trabeculation through the bone lesion at 6 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|6 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
1287885|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 6 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 months. Participants were seen 6 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|6 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
1287886|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 12 Months|Bone trabeculation through the bone lesion at 12 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|12 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
1287887|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 12 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 12months. Participants were seen 12 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|12 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
1287888|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 18 Months|Bone trabeculation through the bone lesion at 18 months with reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|18 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
1287889|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 18 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 18 months. Participants were seen 18 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|18 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
1287890|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 24 Months|Bone trabeculation through the bone lesion at 24 months as determined with radiographs. There were several participants with incomplete follow up or incomplete radiographs. .|24 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs at this time point.|||percentage of trabeculation||Full Range|Mean
1287891|NCT00147823|Primary|Resorption of Graft Material (GR) Compared at 24 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation, at 24 months .Participants were seen 24 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|24 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this timepoint.|||percentage of resorption||Full Range|Mean
1287892|NCT00147745|Primary|Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose|Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.|Baseline (Day -4) to first dose (Day 1)|The entire study population was included in this analysis|||mg*hr/dL||Standard Deviation|Mean
1287893|NCT00147745|Secondary|Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks|The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.|Baseline to 12 weeks|"One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis.~The least squares mean is adjusted for baseline values. This corrects for differences in baseline values between treatment groups."|||percent||Standard Error|Least Squares Mean
1287894|NCT00147745|Secondary|The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks|The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption.|Baseline to 12 weeks|One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis.|||mg*hr/dL||Standard Error|Least Squares Mean
1287895|NCT00147745|Primary|Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.|The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin.|Baseline to 12 weeks|The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.|||mg/kg/min||Standard Error|Least Squares Mean
1287896|NCT00147745|Primary|Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.|The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin.|Baseline to 12 weeks|The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.|||mg/kg/min||Standard Error|Least Squares Mean
1287909|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b|Maximum Observed Plasma Concentration|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
1287897|NCT00147537|Secondary|Duration of Response (DR) in Phase 2|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|Due to the status of the program, duration of response was not analyzed.||||||
1287898|NCT00147537|Secondary|Time to Progression (TTP) in Phase 2|Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|Due to the status of the program, time to progression was not was not analyzed.||||||
1287899|NCT00147537|Secondary|Progression-Free Survival (PFS): Phase 2|Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments.|||months||90% Confidence Interval|Median
1287900|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2|Maximum Observed Plasma Concentration|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|Cmax was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.||||||
1287901|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2|Concentration at 504 hours post dose|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|C504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.||||||
1287902|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|AUC504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.||||||
1287903|NCT00147537|Secondary|Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2|Systemic clearance.|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|Clearance (CL) were not calculated based on the status of the program and the limited value this further PK analyses would provide.||||||
1287904|NCT00147537|Secondary|Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|Volume of distribution (Vd) was not calculated based on the status of the program and the limited value this further pharmacokinetic analyses would provide.||||||
1287905|NCT00147537|Secondary|The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2|The QLQ-C30/-LC13 is a 43 item, self-administered questionnaire designed to assess health outcomes in clinical trials. In addition to global quality of life, the measure assesses 5 functional domains (physical, role, cognitive, emotional and social functioning) and specific symptoms (eg, nausea, pain). Each item is rated on a 1-4 scale with ‘1’ representing “not at all” and ‘4’ “very much”. Within domains, items are scored to obtain a total score with higher scores representative of poorer HRQoL. Scale score range: 0 to 100.|Day 1 pre-dose of Cycle 1, monthly prior to each cycle (up to 17 cycles, each cycle was 21 day), and follow up (one year post last study dose)|Due to the status of the program, no participants were analyzed for EORTC-QLQ-C30/-LC13 in phase 2.||||||
1287906|NCT00147537|Secondary|M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2|The MDASI is a 19-item questionnaire that assesses the severity of 13 symptoms over the past 24 hours, as well as how much the symptoms interfered with 6 areas of function (eg, walking, work, mood), when the symptom was “at its worst”. Each item is scored from 0 to 10, with ‘0’ indicating that the symptom was either not present or did not interfere with their activities, and ‘10’ indicating that the symptom was “as bad as you can imagine” or “interfered completely” with their life. Total average score range: 0 to 10.|Day 1 pre-dose of Cycle 1, weekly for Cycle 1 and 2, monthly prior to each subsequent cycle (Cycle 3 up to Cycle 17, each cycle was 21 day), and follow up (one year post last study dose)|Due to the status of the program, no participants were analyzed for MDASI in phase 2.||||||
1287907|NCT00147537|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2|HAHA are indicators of immunogenicity to CP-751,871|Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion|All participants who received any of the study treatments. N=number of participants who were analyzed for HAHA|||number of participants|||Number
1287908|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b|Maximum Observed Plasma Concentration|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
1287910|NCT00147537|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg.hr/L||Standard Deviation|Mean
1287911|NCT00147537|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg.hr/L||Standard Deviation|Mean
1287912|NCT00147537|Secondary|Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b|Accumulation ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||ratio||Standard Deviation|Mean
1287913|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b|Concentration at 504 hours post dose|Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
1287914|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b|Concentration at 504 hours post dose|Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
1287915|NCT00147537|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||Day||Standard Deviation|Median
1287916|NCT00147537|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||Day||Standard Deviation|Mean
1287917|NCT00147537|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg.hr/L||Standard Deviation|Mean
1287918|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg.hr/L||Standard Deviation|Mean
1287919|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||milligram.hour/Liter (mg.hr/L)||Standard Deviation|Mean
1287920|NCT00147537|Secondary|Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b||Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
1287921|NCT00147537|Secondary|Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b||Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||milligram/liter (mg/L)||Standard Deviation|Mean
1287922|NCT00147537|Secondary|Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b|Blood samples were collected to enumerate the number of total CTCs and CTC insulin-like growth factor 1 receptor (IGF-IR) expression|Day 1 pre-dose and Days 15 to 21 of Cycle 4|Per protocol amendment 6, blood samples for the rapid quantification of CTCs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.||||||
1287923|NCT00147537|Secondary|Number of Circulating Endothelial Cells (CECs): Phase 1b||Day 1 pre-dose and Days 15 to 21 of Cycle 4|Per protocol amendment 6, blood samples for the rapid quantification of CECs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.||||||
1287924|NCT00147537|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b|HAHA are indicators of immunogenicity to CP-751,871.|Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)|All participants who received at least one dose of any agent. N=number of participants who were analyzed for HAHA|||number of participants|||Number
1288316|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 8)||Baseline to Week 8|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287925|NCT00147537|Secondary|Objective Response Rate: Phase 1b|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received at least one dose of any agent. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment|||percentage of participants|||Number
1287926|NCT00147537|Primary|Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment|||percentage of participants||90% Confidence Interval|Number
1287927|NCT00147537|Primary|Objective Response Rate: Phase 2|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment|||percentage of participants||90% Confidence Interval|Number
1287928|NCT00147537|Primary|Recommended Phase 2 Dose (RP2D): Phase 1b||Start of treatment (baseline) up to the end of Cycle 1 (Day 21)|All participants who received at least one dose of any agent.|||mg/kg|||Number
1287929|NCT00147537|Primary|Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b|The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.|Start of treatment (baseline) up to the end of Cycle 1 (Day 21)|All participants who received at least one dose of any agent.|||mg/kg|||Number
1287930|NCT00147498|Secondary|Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)|Disease improvement was classified as good, moderate, and no change based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate improvement. Scores of good and moderate were considered to have therapeutic response.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||participants|||Number
1287931|NCT00147498|Secondary|Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and <2.6 = remission.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all participants who were randomized to study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for a particular time-point for each treatment arm, respectively.|||units on a scale||Standard Deviation|Mean
1287932|NCT00147498|Secondary|Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1287933|NCT00147498|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
1288317|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 4)||Baseline to Week 4|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1287934|NCT00147498|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
1287935|NCT00147498|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Mean
1287936|NCT00147498|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Mean
1287937|NCT00147498|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
1287938|NCT00147498|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
1287939|NCT00147498|Secondary|Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
1287940|NCT00147498|Secondary|Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
1287941|NCT00147498|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
1287942|NCT00147498|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
1287943|NCT00147498|Secondary|Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Error|Mean
1287955|NCT00147316|Primary|Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months|The number of patients with a mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|at 3 months||||participants|||Number
1287944|NCT00147498|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Error|Mean
1287945|NCT00147498|Secondary|Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Error|Mean
1287946|NCT00147498|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Error|Mean
1287947|NCT00147498|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n: calculated by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 6|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale*weeks||Standard Deviation|Mean
1287948|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1287949|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1287950|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, and 4. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
1287951|NCT00147498|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1287952|NCT00147446|Secondary|No.of New or Enlarged T2 Lesions From Week 8 to Week 24|T2-weighted MRI is commonly used in phase II trials to identify more permanent lesions. The single value was calculated by summing up the lesions from week 8 to week 24.|week 8 to week 24||||participants|||Number
1287953|NCT00147446|Primary|No.of Gd+ Lesions From Week 8 to Week 24|Gd+ is Gadolinium-enhancing MRI brain lesion, A marker of the opening of the blood-brain barrier and is typically used as a primary endpoints in phase II trials because of its high sensitivity to ongoing MS disease activity and its association with clinical exacerbation. The single value was calculated by summing up the lesions from week 8 to week 24.|week 8 to week 24|A total of 121 patients with relapsing forms of MS were randomized to SMT-MS or WLC. Participants were enrolled at MS specialty clinics at 3 sites in the United States (UCSF; Evergreen Hospital Medical Center, and the Feinberg School of Medicine at Northwestern University, Chicago, Illinois) and through local chapters of the National MS Society.|||participants|||Number
1287954|NCT00147316|Primary|Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours|The number of patients with sICH|within 36 hours||||participants|||Number
1287960|NCT00147290|Primary|Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.|Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with GEE method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.|one year||||Percent of VT episodes terminated|||Number
1287961|NCT00147277|Secondary|Evaluate Different Possible Predictors of ATP Success||one year|||||||
1287962|NCT00147277|Secondary|Compare Likelihood of Syncopal Events Associated With FVT||one year|||||||
1287963|NCT00147277|Secondary|Percent Reduction in Shocks Delivered Per Patient for Treating FVT||one year|||||||
1287964|NCT00147277|Secondary|Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms||one year|||||||
1287965|NCT00147277|Secondary|Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention||one year|||||||
1287966|NCT00147277|Primary|Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)|Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.|one year|934 patients were created in the electronic data capture system, only 925 patients were enrolled in the study: 4 patients in the 8 pulses arm and 5 patients in the 15 pulses arm were created by mistake and excluded from analysis. The analysis were performed with the Intention To Treat (ITT) method.|||Percentage of FVT episodes terminated|||Number
1287967|NCT00147238|Primary|Sensitivity of MRI Per Patient|Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).|MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI|Primary outcome measure was not assessed due to early study termination (e.g. patients did not receive assigned treatment).||||||
1287968|NCT00147225|Primary|Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy|Number of participants experiencing an venous thromboembolism (VTE) related serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study. VTE events reported are part or whole total number reported for study SAEs, not in addition to SAEs reported.|Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles|All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.|||participants|||Number
1287969|NCT00147225|Primary|Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy|Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.|Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles|All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.|||participants|||Number
1287970|NCT00147212|Primary|The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response|Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)|Participants were followed until disease progression, an average of 6 months|Intent to treat|||participants|||Number
1287971|NCT00147199|Secondary|N-terminal Pro-B-Type Natriuretic Peptide (NT Pro-BNP)|Change in NT pro-BNP from Baseline to Week 12. Plasma samples were collected from patients at Baseline and Week 12 in order to measure any change over time in circulating plasma levels of this biomarker.|12 weeks|Per protocol|||pg/mL||Inter-Quartile Range|Median
1287972|NCT00147199|Secondary|Change in Signs and Symptoms of PAH|Signs and symptoms of PAH (Loud P2 sound, Ascites, Right ventricular S3 sound, Dyspnea, Right ventricular S4 sound, Orthopnea, Right ventricular heave, Dizziness, Murmur of tricuspid insufficiency, Syncope, Murmur of pulmonic insufficiency, Chest pain, Hepatomegaly, Palpitations, Jugular venous distension at 45 degrees, Fatigue, Edema) were assessed at Baseline and Week 12. The status of each sign and symptom (“absent” or “present”) was assessed at each visit. To assess overall change from baseline in signs and symptoms, a “1” was assigned for each sign and symptom that was “present” at the Week 12 but was “absent” at baseline, a “-1” was assigned for each sign and symptom that was “absent” at Week 12 but was “present” at baseline, and a “0” was assigned for no change. An overall change score at each post-baseline assessment was then calculated by summing these values for all signs and symptoms. The overall change score had the potential to range from -17 to 17.|12 weeks|Intention to treat population.|||units on a scale||Full Range|Median
1287973|NCT00147199|Secondary|Quality of Life (Minnesota Living With Heart Failure)|Quality of life as measured by the Minnesota Living With Heart Failure (MLWHF) questionnaire was evaluated at baseline and at Week 12. The MLWHF questionnaire consists of 21 questions assessing how the patient’s heart failure has prevented them from living the way they wanted during the defined time period. Each question was graded by the patient with a numeric value between 0 (No/none) and 5 (very much). These scores were then summed across the 21 questions for a Global Score. Global scores ranged from 0 to 105. These questions were further grouped into Physical (8 of the questions) and Emotional (5 of the questions) dimensions to further characterize the effect of heart failure on the patient’s life. Physical scores ranged from 0 to 40, and emotional scores ranged from 0 to 25. For all 3 categories, the lower the score, the better the outcome. Values presented as change from Baseline.|12 weeks|Intention to treat population.|||units on a scale||Inter-Quartile Range|Median
1287974|NCT00147199|Secondary|Peak 6MWD at Week 6|Change in peak 6MWD between Baseline and Week 6.|6 weeks|Intention to treat|||meters||Inter-Quartile Range|Median
1287976|NCT00147199|Secondary|New York Heart Association (NYHA) Functional Classification|"Change in NYHA functional class at Week 12. NYHA classifications:~Class I – Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope.~Class II – Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III – Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class IV – Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."|12 weeks|Intention to treat population|||participants|||Number
1287977|NCT00147199|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a patient reported number between 0 (no perceived shortness of breath) and 10 (maximum perceived shortness of breath), obtained at the completion of each 6MWT.|12 weeks|Intention to treat population. A Week 12 observation was not present for one subject and that data point is not included in the analysis.|||score||Standard Deviation|Mean
1287978|NCT00147199|Secondary|Clinical Worsening Events|Clinical worsening was defined as the first incidence of clinical worsening from randomization to the first occurrence of death, transplantation, hospitalization for PAH, or initiation of additional approved PAH therapy.|12 weeks|Intention to treat population|||clinical worsening events|||Number
1287979|NCT00147199|Primary|Peak 6-minute Walk Distance|Change in peak 6-minute walk distance from baseline to Week 12. Peak 6MWD was defined as a 6-minute walk test (6MWT) within 10 to 60 minutes after study drug inhalation|12 weeks|Intention to treat analysis|||meters||Inter-Quartile Range|Median
1287980|NCT00147030|Secondary|Microcephaly|Head circumference at follow-up >2 standard deviations below the mean|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
1287981|NCT00147030|Secondary|Epilepsy (Defined as Recurrent Seizures Beyond the Neonatal Period, Requiring Anticonvulsant Therapy at the Time of Assessment)||18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
1287982|NCT00147030|Secondary|Sensorineural Hearing Loss|Normal or near normal hearing, no sensorineural hearing loss|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
1287983|NCT00147030|Secondary|Bayley Psychomotor Developmental Index Score (PDI)|Bayley Psychomotor Developmental Index score (PDI) <70|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
1287984|NCT00147030|Secondary|Multiple Handicap|defined as the presence of any two of the following in an infant; neuromotor disability (Level 3-5 on Gross Motor Function classification), mental delay (Bayley Mental Developmental Index (MDI) score < 70), epilepsy, cortical visual impairment, sensorineural hearing loss|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
1287985|NCT00147030|Secondary|Severe Neurodevelopmental Disability||18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
1287986|NCT00147030|Secondary|Mortality||18 months||||participants|||Number
1287987|NCT00147030|Secondary|Duration of Hospitalisation|Total duration of hospital care|Duration of hospital stay, on average 22 days||||days||Inter-Quartile Range|Median
1287988|NCT00147030|Secondary|Pulmonary Airleak||Duration of hospital stay, on average 22 days||||participants|||Number
1287989|NCT00147030|Secondary|Pneumonia||Before discharge from hospital||||participants|||Number
1287990|NCT00147030|Secondary|Renal Failure Treated With Dialysis||Duration of hospital stay, on average 22 days||||participants|||Number
1287991|NCT00147030|Secondary|Major Venous Thrombosis||Duration of hospital stay, on average 22 days||||participants|||Number
1287992|NCT00147030|Secondary|Thrombocytopenia||Duration of hospital stay, on average 22 days||||participants|||Number
1287993|NCT00147030|Secondary|Cardiac Arrhythmia|Arrhythmia identified on electrocardiogram (ECG), e.g. sinus bradycardia <80 beats per minute, ventricular arrhythmia.|Duration of hospital stay, on average 22 days||||participants|||Number
1287994|NCT00147030|Secondary|Necrotising Enterocolitis||Duration of hospital stay, on average 22 days||||participants|||Number
1287995|NCT00147030|Secondary|Culture Proven Sepsis||Duration of hospital stay, on average 22 days||||participants|||Number
1287996|NCT00147030|Secondary|Prolonged Blood Coagulation Time||Duration of hospital stay, on average 22 days||||participants|||Number
1287997|NCT00147030|Secondary|Pulmonary Hypertension||Duration of hospital stay, on average 22 days||||participants|||Number
1287998|NCT00147030|Secondary|Pulmonary Haemorrhage||Duration of hospital stay, on average 22 days||||participants|||Number
1287999|NCT00147030|Secondary|Persistent Hypotension|Hypotension was defined as a mean blood pressure of 40 mm Hg or less and was persistent if causes of hypotension had been sought and appropriate treatment provided, without success.|Duration of hospital stay, on average 22 days||||participants|||Number
1288000|NCT00147030|Secondary|Intracranial Haemorrhage|Intracranial hemorrhage was identified on magnetic resonance imaging (MRI).|Duration of hospital stay, on average 22 days||||participants|||Number
1288001|NCT00147030|Primary|Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors|Severe neurodevelopmental disability was defined as a score of less than 70 on the Mental Developmental Index of the Bayley Scales of Infant Development II (BSID-II) (on which the standardization mean [± standard deviation (SD)] is 100±15 and higher scores indicate better performance), a score of 3 to 5 on the Gross Motor Function Classification System (GMFCS) (on which scores can range from 1 to 5, with higher scores indicating greater impairment), or bilateral cortical visual impairment with no useful vision.|18 months||||participants|||Number
1288002|NCT00146848|Secondary|Change in Self Assessed Physical Activity|Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.|From randomization (6-weeks) through 12-month visit|Physical activity was assessed using the Physical Activity Scale for the Elderly and was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups. Postive values for changes denote improvements.|||units on a scale||Standard Deviation|Mean
1288003|NCT00146848|Primary|Clinical Composite Score|The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association [NYHA] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.|From randomization (6-weeks) through 12-month visit|This analysis is intention to treat (ITT) in terms of patient's being analyzed according to their randomized group. Last observation carried forward (LOCF) method was used for missing NYHA and global assessment measures at 12 months.|||participants|||Number
1288004|NCT00146848|Secondary|Change in Quality of Life|Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.|From randomization (6-weeks) through 12-month visit|Quality of Life was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups.|||units on a scale||Standard Deviation|Mean
1288005|NCT00146770|Other Pre-specified|Change From Baseline to Week 182 in Urinary GAG Level|Urinary Glycosaminoglycan (GAG) Levels: >> Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||ug GAG/mg Creatinine||Standard Deviation|Mean
1288006|NCT00146770|Secondary|Change From Baseline to Week 182 in Active Joint Range of Motion (ROM)|Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one’s arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.|Baseline to Week182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||Degrees||Standard Deviation|Mean
1288007|NCT00146770|Secondary|Change From Baseline to Week 182 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score|CHAQ/HAQ = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||Units on a scale||Standard Deviation|Mean
1288008|NCT00146770|Secondary|Change From Baseline to Week 182 in Liver Volume|Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||Cubic centimeters (cm3)||Standard Deviation|Mean
1288009|NCT00146770|Secondary|Change From Baseline to Week 182 in Apnea/Hypopnea Index (AHI)|Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||Events per Hour||Standard Deviation|Mean
1288010|NCT00146770|Primary|Change From Baseline to Week 182 in Six Minute Walk Test (6MWT)|Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.|||Meters||Standard Deviation|Mean
1288011|NCT00146770|Primary|Change From Baseline to Week 182 in Percent Predicted Forced Vital Capacity (FVC)|Percent Predicted Forced Vital Capacity: the maximal exhaled breath volume following a maximal inhaled breath. Overall change from Baseline to Week 182 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.|Baseline to Week 182|This study enrolled patients who completed the Phase 3 Double-Blind Study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.|||percent predicted FVC||Standard Deviation|Mean
1288012|NCT00146757|Other Pre-specified|Investigator’s Clinical Assessment at Week 52 Compared With Baseline|The Investigator’s impression of the patient’s overall clinical status at Week 52 compared with Baseline.|Baseline to 52 weeks|The analysis was intent-to-treat.|||participants|||Number
1288013|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Height|Change in Z-scores for standing height/lying-length-for-age from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Units on a scale||Standard Deviation|Mean
1288014|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Left Ventricular Mass (LVM) Z-Score|Change in LVM Z-scores as measured by echocardiography from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Units on a scale||Standard Deviation|Mean
1288015|NCT00146757|Other Pre-specified|Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline|Independent experts provided a global assessment for each sleep study visit as well as the degree of clinically meaningful change over the course of the study. Assessment was based on AHI, severity and frequency of oxygen desaturations and sleep quality.|Baseline to 52 weeks|The analysis was intent-to-treat.|||participants|||Number
1288016|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Apnea/Hypopnea Index (AHI)|Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events per hour indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Events per hour||Standard Deviation|Mean
1288017|NCT00146757|Other Pre-specified|Percent Change From Baseline to Week 52 in Liver Size (Hepatomegaly)|Percent change in extent of Liver Edge Below Right Costal Margin (BRCM) measured in centimeters from Baseline to Week 52; A greater decrease in percent change indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Percentage of change||Standard Deviation|Mean
1288018|NCT00146757|Other Pre-specified|Percent Change From Baseline to Week 52 in Urinary Glycosaminoglycan (uGAG) Level|Percentage change in the concentration of GAG relative to creatinine (ug GAG/mg creatinine) in urine from Baseline to Week 52; A greater decrease in percent change indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Percentage of change||Standard Deviation|Mean
1288019|NCT00146757|Primary|Pharmacokinetics - Volume of Distribution (Vz)|Vz is the volume that relates the amount of drug in the body after absorption is complete to the concentration of drug in the plasma.|52 weeks|The analysis was intent-to-treat.|||liters/kilograms||Standard Deviation|Mean
1288020|NCT00146757|Primary|Pharmacokinetics - Total Plasma Clearance (CL)|CL is volume of the body fluid cleared of the drug per unit of time.|52 weeks|The analysis was intent-to-treat.|||(milliliters/minute)/kilograms||Standard Deviation|Mean
1288021|NCT00146757|Primary|Pharmacokinetics - Elimination Half Life (t1/2)|Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.|52 weeks|The analysis was intent-to-treat.|||hours||Standard Deviation|Mean
1288022|NCT00146757|Primary|Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)|AUC∞ is a measure of the total exposure to a drug.|52 weeks|The analysis was intent-to-treat.|||hours units/milliliters||Standard Deviation|Mean
1288023|NCT00146757|Primary|Safety Evaluation|Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.|52 weeks|The number of participants was determined as adequate to assess the safety of Aldurazyme in young children with mucopolysaccharidosis I (MPS I). The analysis was intent-to-treat.|||participants|||Number
1288024|NCT00146640|Secondary|Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
1288025|NCT00146640|Secondary|Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
1288026|NCT00146640|Secondary|Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
1288027|NCT00146640|Secondary|Relative Change From Baseline in Quality of Sleep at Week 12|Participants assessed quality of sleep on a 100 mm VAS, where 0 mm = very good, 100 mm = very bad. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
1288028|NCT00146640|Secondary|Relative Change From Baseline in Pain Intensity at Week 12|Participants assessed pain intensity on a 100 millimeter (mm) visual analog scale (VAS), where 0 mm = no pain, 100 mm = worst pain. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
1288029|NCT00146640|Secondary|Percentage of Participants With Recurrence of Joint Stiffness at Week 12|Participants recorded the status of recurrence of joint stiffness (Yes/No) in diary data. Percentage of participants who selected Yes for recurrence of joint stiffness, are reported.|Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
1288030|NCT00146640|Secondary|Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total DAS28 score range from 0 to approximately 10. DAS28 less than or equal to (≤) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity, and DAS28 >5.1 = severe disease activity. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
1288031|NCT00146640|Primary|Relative Change From Baseline in Duration of Morning Stiffness at Week 12|Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1288032|NCT00146328|Secondary|Change From Baseline in CD4 Cell Count (LOCF)|Change from baseline in CD4 cell count with last observation carried forward(LOCF).|Baseline to 192-240 week time interval|FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4,1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed.|||cells/mm3||Standard Deviation|Mean
1288033|NCT00146328|Secondary|Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)|Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF)|Baseline to 192-240 week time interval|FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and rolled into 1182.17|||Log 10 copies/mL||Inter-Quartile Range|Median
1288034|NCT00146328|Primary|Number of Patients With Adverse Events Leading to Death|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
1288035|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
1288036|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288037|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
1288038|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
1288039|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
1288040|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
1288041|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
1288042|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
1288043|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288044|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288045|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288046|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288047|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288048|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288049|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288050|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288051|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288052|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288133|NCT00145574|Primary|Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288053|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288054|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288055|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288056|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288057|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
1288058|NCT00146172|Primary|Maximum Tolerated Dose (MTD)|If 2 or more, of 3 to 6 subjects, at a dose level had an neratinib-related dose limiting toxicity (DLT) by day 14 of continuous daily dose administration, dose escalation stopped and the prior dose level was considered the MTD.|From first dose date to day 14|All patients receiving neratinib in the dose escalation part of the study.|||mg|||Number
1288059|NCT00146172|Secondary|Clinical Benefit Rate|Patients with PR or higher responses or SD>=24 weeks, evaluable population|From first dose date to progression/death or last assessment, up to 39 weeks.|Breast, Lung and other solid tumors included in the efficacy evaluable population|||percentage of participants||95% Confidence Interval|Number
1288060|NCT00146172|Secondary|Objective Response Rate|Patients with PR or higher responses, evaluable population|From first dose date to progression/death or last assessment, up to 39 weeks|Breast, Lung and other solid tumors included in the efficacy evaluable population|||percentage of participants||95% Confidence Interval|Number
1288061|NCT00146172|Secondary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression or death, up to 39 weeks.|All subjects who were assigned to treatment, received at least 14 days of continuous dose administration of test article, and who had undergone at least 1 follow-up tumor assessment, evaluable population|||months||95% Confidence Interval|Median
1288062|NCT00146172|Secondary|Duration of Response|Duration of response of responders (PR+) by Kaplan-Meier estimate|From start date of response to first PD, up to 39 weeks.|Subjects responses classified as complete response or partial response in evaluable population|||months||95% Confidence Interval|Median
1288063|NCT00146172|Secondary|Number of Participants With Best Overall Response|Best Overall response by tumor type, evaluable population per Response Evaluation Criteria In Solid Tumors Criteria v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (LD) of target lesions in reference to baseline sum of LD of target lesions; Progressive Disease (PD), >=20% increase in sum of LD of target lesions, taking as reference the smallest sum of recorded LD of target lesions since treatment started or appearance of 1 or more new lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD of target lesions since the treatment start. The best overall response was the best response recorded from start of treatment until PD/recurrence. In general, the subject’s best response assignment depended on achievement of both measurement and confirmation criteria.|From first dose date to progression or last tumor assessment, up to 39 weeks.|Subjects who had received at least 14 days of continuous dose administration of test article and who had undergone at least 1 follow-up tumor assessment, evaluable population|||Participants|||Count of Participants
1288064|NCT00146172|Primary|Dose Limiting Toxicity (DLT)|DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.|From first dose date to day 14|Subjects in the dosing groups 40 mg through 400 mg, excluding the selection of MTD.|||Participants|||Count of Participants
1288065|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Spectral Density Coefficient Beta (BETA) From Baseline to Month 24|The Percent Change in Radiographic Texture Analysis (RTA) spectral density coefficient beta (BETA) from Baseline to Month 24 is an analysis of spectral density vs. the spacial frequency on a log-log plot. BETA is the coefficient (slope) of this plot. Higher values of beta correspond to rougher (strong bone) and lower values to smoother, higher-frequency texture pattern (washed out bone).|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288066|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) From Baseline to Month 24|The Percent Change in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) from Baseline to Month 24 is a description of the similarity of texture of the images at different magnifications. The Minkowski fractal dimension is calculated from the slope of the least -square fitted line relating log volume and log magnification.|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288067|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Minimum First Moment of the Power Spectrum (minFMP) From Baseline to Month 24|To derive a measure of variability and directionality in the first moment of the power spectrum (FMP) in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals and FMP is calculated for each segment. We use minFMP (minimum FMP) to represent the lowest value of FMP across the 24 angular sectors corresponding to the special frequency in the most washed-out direction. FMP characterizes spatial frequency in the radiographic pattern and the underlying trabecular structure. This corresponds to the coarseness or fineness of the radiographic texture pattern. A high level of FMP indicates thin and closely spaced trabecular structure. Low FMP indicates widely spaced dark areas usually corresponding to a strong, thick trabecular structure.|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288068|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Feature Integrated First Moment of the Power Spectrum (iFMP) From Baseline to Month 24|To derive a measure of variability and directionality in the first moment of the power spectrum (FMP) in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and FMP is calculated for each segment. We use iFMP (integrated FMP) as a measure of overall special frequency of the radiographic pattern. FMP characterizes spatial frequency in the radiographic pattern and the underlying trabecular structure. This corresponds to the coarseness or fineness of the radiographic texture pattern. A high level of FMP indicates thin and closely spaced trabecular structure. Low FMP indicates widely spaced dark areas usually corresponding to a strong, thick trabecular structure.|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288069|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Feature Standard Deviation of Root Mean Square (sdRMS) From Baseline to Month 24|"Root Mean Square (RMS) is a measure of the variability in the radiographic texture pattern, the relative difference in the contrast between light and dark areas is expressed in a grayscale level. In practical terms, a bone image with a washed-out appearance due to loss of trabecular structure such as that seen in osteoporosis, will have a low value for RMS because there will be relatively little contrast between lighter and darker areas of the image. An image of a bone with strong trabecular structure will have a high RMS value because the contrast between the lighter and darker areas of the image will be greater.~To derive a measure of variability in the RMS in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and RMS is calculated for each segment. We use sdRMS (standard deviation of the RMS across the segments) as a measure of the direction dependence (anisotropy) of the trabeculae in the bone image."|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288070|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Integrated Root Mean Square (iRMS) From Baseline to Month 24|"Root Mean Square (RMS) is a measure of the variability in the radiographic texture pattern, the relative difference in the contrast between light and dark areas is expressed in a grayscale level. In practical terms, a bone image with a washed-out appearance due to loss of trabecular structure such as that seen in osteoporosis, will have a low value for RMS because there will be relatively little contrast between lighter and darker areas of the image. An image of a bone with strong trabecular structure will have a high RMS value because the contrast between the lighter and darker areas of the image will be greater.~To derive a measure of variability in the RMS in the region of interest in the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and RMS is calculated for each segment. The iRMS (integrated RMS) roughly corresponds to RMS averaged across all 24 angular sectors"|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288071|NCT00145977|Secondary|Changes in Total Hip BMD +/- Treatment With Alendronate|Percent Change in total hip BMD from Baseline to Month 24|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288072|NCT00145977|Secondary|Changes in Femoral Neck BMD +/- Treatment With Alendronate|Percent Change in femoral neck BMD from Baseline to Month 24|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288073|NCT00145977|Secondary|Changes in Peripheral Heel BMD +/- Treatment With Alendronate|Percent Change in peripheral heel BMD from Baseline to Month 24|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288074|NCT00145977|Primary|Changes in Lumbar Spine BMD +/- Treatment With Alendronate|Percent Change in lumbar spine BMD from Baseline to Month 24|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
1288075|NCT00145795|Secondary|Rates of Virologic Failure|Virologic failure defined as HIV RNA > 2,000 copies/mL|6 months||||percentage of randomized subjects|||Number
1288076|NCT00145795|Secondary|Clinical HIV-related Events|"Number of participants experiencing clinical HIV-related events as defined by category A, category B, and Appendix B in the 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults (http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm)."|6 months||||number of participants with event(s)|||Number
1288077|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [6 Months]||6 months||||percent apoptosis||Standard Deviation|Mean
1288078|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [3 Months]||3 months||||percent apoptosis||Standard Deviation|Mean
1288081|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [3 Months]|Ex vivo T cell apoptosis can be assessed many different ways. The use of propidium iodide staining to determine the proportion of isolated cells that have undergone apoptosis after ex vivo incubation is a standard method that has been used by many investigators. Apoptotic cells intercalate less PI into their DNA, and on flow cytometry, this cell population is identified by a decrease in mean fluorescence (shift to the left). We have experience with this assay, and we have published on the use of method for determining rates of ex vivo apoptosis for different immune effector cells.|3 months||||percent apoptosis||Standard Deviation|Mean
1288082|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [3 Months]|Ex vivo T cell apoptosis can be assessed many different ways. The use of propidium iodide staining to determine the proportion of isolated cells that have undergone apoptosis after ex vivo incubation is a standard method that has been used by many investigators. Apoptotic cells intercalate less PI into their DNA, and on flow cytometry, this cell population is identified by a decrease in mean fluorescence (shift to the left). We have experience with this assay, and we have published on the use of method for determining rates of ex vivo apoptosis for different immune effector cells.|3 months||||percent apoptosis||Standard Deviation|Mean
1288083|NCT00145795|Primary|Immune Reconstitution [6 Months]|Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 6 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortality outcomes.|6 months||||cells per cubic millimeter||Standard Deviation|Mean
1288084|NCT00145795|Primary|Immune Reconstitution [3 Months]|Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 3 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortality outcomes.|3 months||||cells per cubic millimeter||Standard Deviation|Mean
1288085|NCT00145704|Primary|Change in Total Body Bone Mineral Density During an 18 Month Period|For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1 monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.|18 months|Data analyis halted, due to low enrollment,no outcomes to report||||||
1288086|NCT00145626|Secondary|Kinetics of Lymphohematopoietic Reconstitution|The lymphohematopoietic reconstitution will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|From 0-3 months after HSCT through 4-5 years after HSCT|Data was not available for analysis for all patients at all time points.|||cells *10^3/µl||Full Range|Median
1288087|NCT00145626|Secondary|Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation|The presence or absence of MRD before and after the bone marrow transplant (BMT) and its frequency distribution will be obtained for each time point separately.|Baseline before HSCT, 1 year post HSCT, and up to 5 years post HSCT|MRD data was collected on only four participants during at least one time point.|||Participants|||Count of Participants
1288088|NCT00145626|Secondary|Incidence of and Risk Factors for Long-term Neurocognitive Deficit.|The long-term neurocognitive deficit will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|Up to 5 Years after transplant|There was not enough data available after 1 year post-transplant to evaluate long term outcomes on this study.||||||
1288089|NCT00145626|Secondary|Incidence of and Risk Factors for Organ Dysfunction.|The organ dysfunction will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|Up to 5 Years after transplant|There was not enough data available after 1 year post-transplant to evaluate long term outcomes on this study.||||||
1288090|NCT00145626|Secondary|Factors Affecting One-year Survival: Minimal Residual Disease (MRD)|Detection of leukemia blasts in bone marrow by flow cytometry|Up to one year after transplant|Only four of the 14 participants had MRD measured at the one-year time point.|||participants|||Number
1288091|NCT00145626|Secondary|Factors Affecting One-year Survival: Match N/6 HLA Loci|HLA typing determined the degree of match by looking at 6 different HLA loci. The results indicate the number of the 6 loci that matched for each participant. Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||participants|||Number
1288092|NCT00145626|Secondary|Factors Affecting One-year Survival: Donor Type|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||participants|||Number
1288093|NCT00145626|Secondary|Factors Affecting One-year Survival: Disease Status at HSCT|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||participants|||Number
1288094|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Dose of NK Cells|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||NKcells X 10^6/kg||Full Range|Median
1288095|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Dose of CD34|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||CD34 X 10^6/kg||Full Range|Median
1288097|NCT00145626|Secondary|Number of Incidences of Chronic GVHD.|"Chronic GVHD was graded according to Seattle Criteria: limited or extensive. Limited is defined as localized skin and/or hepatic dysfunction. Extensive is defined as one or more of the following:~generalized skin involvement~liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis~eye dryness with Schirmer's test <5 mm wetting~oral: involvement of salivary glands or oral mucosa~other: another target organ involvement"|Up to 5 years after transplant||||Participants|||Count of Participants
1288098|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Fatal Acute Graft-Versus Host Disease (GVHD)|The cumulative incidence estimate for occurrence of fatal acute GVHD by the end of the first 100 days post-transplant was calculated using method of Kalbfleisch and Prentice.|100 days post-transplantation||||Number of Deaths|||Number
1288099|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Engraftment Failure|Engraftment failure is defined as <10% donor cell chimerism at any time point between 28 and 100 days after transplant with no evidence of disease relapse or requiring stem cell boost.|100 days post-transplantation||||proportion of engraftment failures||95% Confidence Interval|Number
1288100|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality|The cumulative incidences of regimen-related mortality will be estimated using method of Kalbfleisch and Prentice.|100 days post-transplantation||||participants|||Number
1288101|NCT00145626|Primary|One-year Survival|"The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system.~The Kaplan-Meier estimate for one-year survival is reported."|One year after transplant||||percentage of participants|||Number
1288102|NCT00145600|Other Pre-specified|Event-free Survival Probability by Risk Group at 10-year Follow-Up|Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.|10-year follow-up after protocol enrollment|||||||
1288103|NCT00145600|Secondary|Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288104|NCT00145600|Secondary|Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288105|NCT00145600|Secondary|Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288118|NCT00145600|Primary|Event-free Survival Probability by Risk Group|Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.|Median 6.4 year follow-up|Nine patients were ineligible for analysis.|||probability of 5 yr. event free survival||95% Confidence Interval|Number
1288176|NCT00145041|Primary|T 1/2|The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.|cycle 1 day 1|all patients enrolled|||hr||Standard Deviation|Mean
1288106|NCT00145600|Secondary|Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288107|NCT00145600|Secondary|Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288108|NCT00145600|Secondary|Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288109|NCT00145600|Secondary|Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288110|NCT00145600|Secondary|Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288111|NCT00145600|Secondary|Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
1288112|NCT00145600|Secondary|Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
1288113|NCT00145600|Secondary|Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
1288114|NCT00145600|Secondary|Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
1288115|NCT00145600|Secondary|Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
1288116|NCT00145600|Secondary|Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
1288117|NCT00145600|Secondary|Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
1288119|NCT00145587|Primary|Engraftment|To determine the need for blood or platelet transfusions and the presence of donor cells being present in the transplant recipient’s bone marrow or peripheral blood by 100 day after transplantation for children with malignant infantile osteopetrosis who have received a haploidentical stem cell graft.|100 days post-transplant|From September 2004 to March 2009, 5 consecutive MIOP patients were treated using mismatched family member donors. Favorable engraftment refers to the transplant patient not requiring blood or platelet transfusions and the presence of donor cells being present in the transplant recipient’s bone marrow or peripheral blood.|||Participants|||Number
1288120|NCT00145574|Secondary|Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26.|Percent change in apolipoprotein B from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288121|NCT00145574|Secondary|Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26.|Percent change in apolipoprotein A-I from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288122|NCT00145574|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26.|Percent change in non-high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288123|NCT00145574|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26.|Percent change in high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288124|NCT00145574|Secondary|Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26.|Percent change in triglycerides from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288125|NCT00145574|Secondary|Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26.|Percent change in total cholesterol (TC) from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288126|NCT00145574|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26.|Percent change in low-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent-to-Treat (ITT) Population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288127|NCT00145574|Secondary|Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8.|Percent change in Apo B (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288128|NCT00145574|Secondary|Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.|Percent change in Apolipoprotien A-I (Apo A-1) (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288129|NCT00145574|Secondary|Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in non-HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288130|NCT00145574|Secondary|Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288131|NCT00145574|Secondary|Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8.|Percent change in triglycerides (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288132|NCT00145574|Secondary|Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8.|Percent change in total cholesterol (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
1288194|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288134|NCT00145509|Primary|Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score|The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.|Baseline and 52 Weeks|Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.|||Score on a scale||Standard Deviation|Mean
1288135|NCT00145509|Primary|Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score|The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.|Baseline and 52 Weeks|Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.|||Score on a Scale||Standard Deviation|Mean
1288136|NCT00145509|Primary|Number of Participants Who Discontinued Because of an Adverse Event|Participants who discontinued study medication due to adverse events.|40 weeks||||participants|||Number
1288137|NCT00145509|Primary|Number of Participants Who Experienced an Adverse Event|Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).|up to 52 weeks||||Participants|||Number
1288138|NCT00145496|Secondary|Change From Baseline in Body Weight||Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.|||kg||Standard Error|Mean
1288139|NCT00145496|Secondary|Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score|The Quality of Life Scale is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 to 126, with greater values indicating better quality of life.|Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.|||Units on a Scale||Standard Error|Mean
1288140|NCT00145496|Primary|Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score|The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 to 96, with greater scores indicating greater severity of symptoms.|Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.|||Units on a Scale||Standard Error|Mean
1288141|NCT00145418|Secondary|Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.|Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.|day one of cycle one until participant removed from trial|all participants had adverse events|||participants|||Number
1288142|NCT00145418|Secondary|Duration of Response|Duration of response is a measure of how long the participants response to therapy was maintained.|0 -12 months||||months||Full Range|Median
1288143|NCT00145418|Secondary|Time to Progression|Progression is measured from each participants start of study until removal from treatment.|<1 cycle to 6 cycles of treatment||||months||Full Range|Median
1288144|NCT00145418|Primary|Response Rate|Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.|Response is measured every 2 cycles until disease progression||||Participants|||Number
1288145|NCT00145327|Secondary|The Number of Participants With Clinically Significant Laboratory Parameters|Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.|||Participants|||Number
1288146|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.|||μmol/L||Standard Deviation|Mean
1288147|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.|||μmol/L||Standard Deviation|Mean
1288148|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.|||μmol/L||Standard Deviation|Mean
1288149|NCT00145327|Secondary|Qualitative Bone Biopsy Parameters|Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).|End of Study Visit at Year 6|Bone Biopsy sub-population.|||Participants|||Number
1288150|NCT00145327|Secondary|Number of Participants With Incidence of Clinical Fracture|Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.|Extension Baseline (Year 3; Month 36) to Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. n = the number of patients with measurements at Year 6 as determined by the analysis window.|||Participants|||Number
1288151|NCT00145327|Secondary|Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures|Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 as determined by the analysis window.|||Percentage of patients|||Number
1288152|NCT00145327|Secondary|Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
1288153|NCT00145327|Secondary|Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
1288154|NCT00145327|Secondary|Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
1288155|NCT00145327|Secondary|Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
1288156|NCT00145327|Secondary|Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
1288157|NCT00145327|Secondary|Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.|||Percentage Change in BMD||Standard Error|Mean
1288158|NCT00145327|Secondary|Bone Resorption and Formation Biochemical Markers at Year 6: P1NP|The amount of serum P1NP as determined by the central laboratory|Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The Number of patients analyzed = the number of patients with measurements in Year 6 as determined by the analysis window.|||ng/mL||Standard Error|Mean
1288159|NCT00145327|Secondary|Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP|The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.|Year 4.5|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 as determined by the analysis window.|||ng/mL||Standard Error|Mean
1288160|NCT00145327|Primary|Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3|The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 − femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)|Modified intent-to-treat (MITT) population. The MITT population included all patients in the ITT population who had DXA measurements of the femoral neck at Year 3 and Year 6. This was the primary population for primary efficacy parameter.|||Percentage Change in BMD||Standard Error|Mean
1288219|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18||Month 18||||L||Standard Error|Mean
1288161|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 168|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 168|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.|||Scores on a scale||Standard Deviation|Mean
1288162|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 70|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 70|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.|||Scores on a scale||Standard Deviation|Mean
1288163|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 42|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 42|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.|||Scores on a scale||Standard Deviation|Mean
1288164|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 14|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 14|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.|||Scores on a scale||Standard Deviation|Mean
1288165|NCT00145249|Secondary|Number of Cryptococcal Isolates With Antifungal Susceptibility|Isolates were collected at days 14 and 70 for assessment of antifungal susceptibility.|Days 14 and 70|The study team has since determined that the assay that was to be utilized did not have sufficient sensitivity/specificity for its intended purpose and therefore these results will not be generated.|||Isolates|||Number
1288166|NCT00145249|Secondary|Mean Days of Hospitalization|Mean days of hospitalization. Includes days subject was hospitalized prior to study enrollment for current hospital stay.|7, 14, 42, and 70 days|The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.|||Days||Standard Deviation|Mean
1288167|NCT00145249|Secondary|Number of Subjects Reporting Immune Reconstitution Inflammatory Syndrome (IRIS)|"Number of subjects reporting immune reconstitution inflammatory syndrome (IRIS) following treatment.~Day = Day relative to first dose of study drug"|14, 42, and 70 days|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data|||Subjects|||Number
1288168|NCT00145249|Secondary|Number of Subjects Meeting the Key Efficacy Endpoint of Treatment Success|Treatment success is defined as a composite of the 3 mycologic and clinical measures: CSF culture conversion; neurologically stable or improved; and alive|14, 42, and 70 days|The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.|||Subjects|||Number
1288169|NCT00145249|Secondary|Number of Subjects With Cerebrospinal Fluid (CSF) Culture Conversion at Multiple Time Points|Number of subjects that have a negative fungal culture at Baseline, Day 14, Day 42, and Day 70.|Baseline, 14, 42, and 70 days|The modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.|||Subjects|||Number
1288170|NCT00145249|Secondary|Number of Deaths|"Number of deaths occurring on study.~Day = Day relative to the first dose of study drug."|14, 42, and 70 days|The Regulatory Safety Population was used in this analysis, which includes all subjects who were randomized, who received at least 1 dose of study drug, and who have any on-study data.|||Subjects|||Number
1288171|NCT00145249|Primary|Number of Dose-limiting Toxicities Attributed to Treatment Regimens|"Events are reported by MedDRA Preferred Term.~Dose limiting toxicities include events that resulted in study drug being adjusted, interrupted, or discontinued."|Day 100|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.|||Events|||Number
1288172|NCT00145249|Primary|Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug|"Events are reported by MedDRA Preferred Term.~Grade 3 - Severe. Incapacitating; inability to perform usual activities and daily tasks; significantly affects clinical status; requires therapeutic intervention.~Grade 4 - Life-threatening. AE is life-threatening.~Grade 5 - Death. AE causes death."|Day 100|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.|||Events|||Number
1288173|NCT00145119|Primary|ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)|ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)|2 year||||participants|||Number
1288174|NCT00145041|Primary|Volume of Distribution|The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour|cycle 1 day 1|all patients enrolled|||mL/m2||Standard Deviation|Mean
1288175|NCT00145041|Primary|Clearance|The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2|Day 1 of Cycle 1|All subjects enrolled|||ml/h/m2||Standard Deviation|Mean
1288177|NCT00144963|Primary|MTD of VSLI|Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.|6 weeks|This study was designed to define the MTD of VSLI. Up to 7 sequential escalating dose cohorts (1.5, 1.825, 2.0, 2.25, 2.4, 2.6, and 2.8 mg/m2) were planned, with at least 3 subjects in each cohort. Escalation to the next higher dose cohort was allowed to proceed only if no nonhematologic DLT was observed.|||mg/m2|||Number
1288178|NCT00144781|Secondary|Change From Baseline to Week 26 in Six Minute Walk Test (6MWT)|Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to 26 Weeks|The analysis was intention to treat.|||meters||95% Confidence Interval|Mean
1288179|NCT00144781|Secondary|Percent Change From Baseline to Week 26 in Liver Organ Volume|A greater decrease in liver volume indicates a greater response.|Baseline to 26 Weeks|The analysis was intention to treat.|||Percentage of Change in Liver Volume||95% Confidence Interval|Mean
1288180|NCT00144781|Primary|Percent Change From Baseline to Week 26 in Urinary Glycosaminoglycan (GAG) Level|Urinary GAG Level - Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to 26 Weeks|Based on the changes in urinary GAG levels observed in the Phase 3 double-blind study, a sample size of 8 patients per group would have sufficient power to detect a 29 percentage point difference between groups in the mean change in urinary GAG levels as being statistically significant. The analysis was intention to treat.|||Percentage of Change in GAG Level||95% Confidence Interval|Mean
1288181|NCT00144391|Primary|Fatigue Impact Scale|change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated|6 months||||units on a scale||Standard Deviation|Mean
1288182|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288183|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288184|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288185|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288186|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288187|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288188|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288189|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288190|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288191|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288192|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288193|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Angina)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
1288220|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12||Month 12||||L||Standard Error|Mean
1288195|NCT00144339|Secondary|Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)|The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used|Day 1 to day 1470||||Participants|||Number
1288196|NCT00144339|Secondary|Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)|The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days|Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days||||Participants|||Number
1288197|NCT00144339|Secondary|Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)|All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.|Day 1 to day 1470||||Participants|||Number
1288198|NCT00144339|Post-Hoc|Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)||Day 1 to day 1440||||Participants|||Number
1288199|NCT00144339|Secondary|Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)|On-treatment defined as day 1 to completion of double blinded treatment plus 30 days|Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days||||Participants|||Number
1288200|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 48||||Units on a scale||Standard Error|Mean
1288201|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 42||||Units on a scale||Standard Error|Mean
1288202|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 36||||Units on a scale||Standard Error|Mean
1288203|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 30||||Units on a scale||Standard Error|Mean
1288204|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 24||||Units on a scale||Standard Error|Mean
1288205|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 18||||Units on a scale||Standard Error|Mean
1288206|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 12||||Units on a scale||Standard Error|Mean
1288207|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 6||||Units on a scale||Standard Error|Mean
1288208|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48||Month 48||||L||Standard Error|Mean
1288209|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48||Month 48||||L||Standard Error|Mean
1288210|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42||Month 42||||L||Standard Error|Mean
1288211|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42||Month 42||||L||Standard Error|Mean
1288212|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36||Month 36||||L||Standard Error|Mean
1288213|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36||Month 36||||L||Standard Error|Mean
1288214|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30||Month 30||||L||Standard Error|Mean
1288215|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30||Month 30||||L||Standard Error|Mean
1288216|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24||Month 24||||L||Standard Error|Mean
1288217|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24||Month 24||||L||Standard Error|Mean
1288218|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18||Month 18||||L||Standard Error|Mean
1288270|NCT00144339|Secondary|Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days||||ml/year||Standard Error|Median
1288271|NCT00144339|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days||||ml/year||Standard Error|Median
1288272|NCT00144339|Secondary|Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days||||ml/year||Standard Error|Median
1288273|NCT00144339|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.||||ml/year||Standard Error|Median
1288274|NCT00144339|Secondary|Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).|From month 6 to 4 years||||Score on scale per year||Standard Error|Mean
1288275|NCT00144339|Secondary|Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|From day 30 to 4 years||||ml/year||Standard Error|Mean
1288276|NCT00144339|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|From day 30 to 4 years||||ml/year||Standard Error|Mean
1288277|NCT00144339|Secondary|Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|From day 30 to 4 years||||ml/year||Standard Error|Mean
1288278|NCT00144339|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|From day 30 to 4 years||||ml/year||Standard Error|Mean
1288279|NCT00144339|Secondary|Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days||||ml/year||Standard Error|Median
1288280|NCT00144339|Secondary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.||||ml/year||Standard Error|Median
1288281|NCT00144339|Primary|Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.|From day 30 to 4 years||||ml/year||Standard Error|Mean
1288282|NCT00144339|Primary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.|From day 30 to 4 years||||ml/year||Standard Error|Mean
1288283|NCT00144300|Secondary|Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs|Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.|Screen (Baseline) and final visit (24 months)|TSlab - treated set with non-missing laboratory evaluations|||participants|||Number
1288284|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline, 2 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288285|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|2 years|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288286|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline, 1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288289|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline, 2 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288290|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|2 years|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288291|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline, 1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288292|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288293|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288294|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline, 2 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288295|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|2 years|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288296|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline, 1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288297|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288298|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline|TS - treated set|||Score on a scale||Standard Deviation|Mean
1288299|NCT00144300|Secondary|Hoehn and Yahr Scale at 2 Years|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Up to 2 years|TS - treated set|||Participants|||Number
1288300|NCT00144300|Secondary|Hoehn and Yahr Scale at 1 Year|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Up to 1 year|TS - treated set|||Participants|||Number
1288301|NCT00144300|Secondary|Hoehn and Yahr Scale at Baseline|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Baseline|TS - treated set|||Participants|||Number
1288302|NCT00144300|Secondary|Expert Panel Overall Assessment Following 1 Year on Drug|Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments|up to 1 years|FAS LOCF - full analysis set with last observation carry forward|||Participants|||Number
1288303|NCT00144300|Primary|Expert Panel Overall Assessment Following 2 Years on Drug|Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments|up to 2 years|FAS LOCF - full analysis set with last observation carry forward|||Participants|||Number
1288304|NCT00144170|Secondary|Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.|"Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.~The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time."|up to 75 weeks of treatment|Safety Set (SAF), included all patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1288305|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 96)||Baseline to Week 96|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1288306|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 88)||Baseline to Week 88|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1288307|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 80)||Baseline to Week 80|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1288308|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 72)||Baseline to Week 72|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
1288321|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response defined as Viral Load<50 copies/mL|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288322|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response defined as Viral Load<50 copies/mL|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288323|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response defined as Viral Load<50 copies/mL|Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288324|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response defined as Viral Load<50 copies/mL|Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288325|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response defined as Viral Load<50 copies/mL|Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288326|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response defined as Viral Load<50 copies/mL|Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288327|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response defined as Viral Load<50 copies/mL|Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288328|NCT00144170|Secondary|Virologic Response at Week 24|Viral Load < 50 copies/mL|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288329|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response defined as Viral Load<50 copies/mL|Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288330|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response defined as Viral Load<50 copies/mL|Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288331|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response defined as Viral Load<50 copies/mL|Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288332|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response defined as Viral Load<50 copies/mL|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288333|NCT00144170|Secondary|Virologic Response|Virologic response defined as Viral Load<50 copies/mL|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288334|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response defined as Viral Load<400 copies/mL|week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288335|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response defined as Viral Load<400 copies/mL|week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288336|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response defined as Viral Load<400 copies/mL|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288337|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response defined as Viral Load<400 copies/mL|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288338|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response defined as Viral Load<400 copies/mL|Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288339|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response defined as Viral Load<400 copies/mL|Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288340|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response defined as Viral Load<400 copies/mL|Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288341|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response defined as Viral Load<400 copies/mL|Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288342|NCT00144170|Secondary|Virologic Response at Week 24|Virologic response defined as Viral Load<400 copies/mL|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288343|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response defined as Viral Load<400 copies/mL|Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288344|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response defined as Viral Load<400 copies/mL|Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288345|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response defined as Viral Load<400 copies/mL|Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288346|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response defined as Viral Load<400 copies/mL|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288347|NCT00144170|Secondary|Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks|Virologic response defined as Viral Load<400 copies/mL|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288348|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response defined as Viral Load<400 copies/mL|Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288349|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 96)||Baseline to Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288350|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 88)||Baseline to Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288351|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 80)||Baseline to Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288352|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 72)||Baseline to Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288353|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 64)||Baseline to Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288354|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 56)||Baseline to Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288355|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 48)||Baseline to Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288356|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 40)||Baseline to Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288357|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 32)||Baseline to Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288358|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 24)||Baseline to Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288359|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 16)||Baseline to Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288360|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 8)||Baseline to Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288361|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 4)||Baseline to Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288362|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 2)||Baseline to Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1288363|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288364|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288365|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288366|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288367|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288368|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288369|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288370|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288371|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1294512|NCT00090545|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of BAY 43-9006 (Sorafenib)|Time to maximum concentration for sorafenib.|0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose||||hours||Full Range|Median
1288372|NCT00144170|Secondary|Virologic Response at Week 24|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288373|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288374|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288375|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288376|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288377|NCT00144170|Secondary|Virologic Response|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288378|NCT00144170|Secondary|Time to Confirmed Virologic Failure Through 96 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1288379|NCT00144170|Secondary|Time to Confirmed Virologic Failure Through 48 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1288380|NCT00144170|Secondary|Time to Treatment Failure Through 96 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1288381|NCT00144170|Secondary|Treatment Response at Week 96|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288382|NCT00144170|Secondary|Treatment Response at Week 88|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288383|NCT00144170|Secondary|Treatment Response at Week 80|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288384|NCT00144170|Secondary|Treatment Response at Week 72|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288385|NCT00144170|Secondary|Treatment Response at Week 64|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288386|NCT00144170|Secondary|Treatment Response at Week 56|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288387|NCT00144170|Secondary|Treatment Response at Week 40|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288388|NCT00144170|Secondary|Treatment Response at Week 32|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288389|NCT00144170|Secondary|Treatment Response at Week 24|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288390|NCT00144170|Secondary|Treatment Response at Week 16|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288391|NCT00144170|Secondary|Treatment Response at Week 8|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1288392|NCT00144170|Secondary|Treatment Response at Week 4|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288393|NCT00144170|Secondary|Treatment Response at Week 2|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288394|NCT00144170|Primary|Time to Treatment Failure Through 48 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1288395|NCT00144170|Primary|Treatment Response at Week 48|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1288396|NCT00144027|Primary|Antipsychotic Medication Adherence|The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from ‘I never missed taking my medicine’ to ‘I stopped taking the medicine altogether’. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine’ and 0=any other response to the medication adherence question.|6-months|"Percent of participants who reported never missed taking my medication at 6-months"|||percentage of participants|||Number
1288397|NCT00143845|Secondary|Percentage of Patients Alive at 2 Years|To estimate the overall survival of patients progression following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.|2 Years|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.|||percentage of participants|||Number
1288398|NCT00143845|Primary|Percentage of Participants With Progression Free Survival|"The second primary objective was to determine the percentage of participants with progression free survival following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.~We define disease progression as disease recurrence within 180 days of transplant."|two years|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.|||percentage of participants|||Number
1288399|NCT00143845|Primary|Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grades 2-4|"The primary objective of this study was to establish the rate of acute GVHD following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies. Glucksberg staging was used for organ grading of GVHD. Clinical GVHD was assessed as follows:~Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 rash and no liver or gut involvement Grade 2: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 GI Grade 3: Stage 0-3 skin with Stage 2-3 liver, or Stage 2-4 GI Grade 4: Stage 4 skin rash, or Stage 4 liver involvement"|100 days|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.|||percentage of participants|||Number
1288400|NCT00143819|Secondary|Photography of Target Lesions|Number of participants with photographs taken|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||Participants|||Count of Participants
1288401|NCT00143819|Secondary|Change in Target Lesion Scoring|The subjects' target lesions (ie, a pair of roughly symmetrical bilateral lesions) on each side of the body were scored by the investigator at each visit. Percent change from baseline was calculated.|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||percent change||Standard Deviation|Mean
1288402|NCT00143819|Secondary|Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels|For subjects with eczema, a global assessment (scale of 0-5: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe; 5 = very severe) was performed and a score recorded for each side of the subject's body, at each visit.|8 weeks|The five (5) subjects in the study who had eczema were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||Participants|||Count of Participants
1288432|NCT00143390|Secondary|Overall Survival (OS)|OS is defined as time from the date of randomization to the date of death.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.|||months||95% Confidence Interval|Median
1288403|NCT00143819|Secondary|Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels|For subjects with psoriasis, a global assessment (scale of 0-5: 0 = clear except for residual discoloration; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 = severe) was performed and a score recorded for each side of the subject's body, at each visit.|8 weeks|The eight (8) subjects in the study who had psoriasis were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||Participants|||Count of Participants
1288404|NCT00143819|Primary|Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks|Subjects assessed the level of pruritus (itching) on the left and right sides of their body at each visit, ticking the values on a 100-mm scale (0 mm = no itching; 100 mm = worst possible itching) for each side. Percent change from baseline was calculated.|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||percent change||Standard Deviation|Mean
1288405|NCT00143598|Secondary|Quality of Life|"The SF-36 is a well-validated generic quality-of-life (QOL) instrument. It includes questions on both physical and mental health. Higher scores indicate a better QOL. The VEINES-QOL is a venous-disease specific QOL measure that consists of 25 items that quantify venous disease effect on QOL, and an embedded symptom sub-questionnaire (VEINES-Sym) with 10 items that measures venous symptoms. Higher scores are associated with better QOL.~The VEINES-QOL/Sym and SF-36 use the standard method for scoring questionnaires with items with different response scales that is now routinely used. Raw scores are first transformed to z score equivalents (mean, 0; standard deviation, 1), which then are transformed to T scores (mean, 50; standard deviation, 10) to give an easily understood range of scores. A person-specific estimate is imputed for any missing item in cases where the patient answered at least 50% of the items in the scale."|24 months|Patients who completed the SF-36 and VEINES-QOL at 24 months follow-up.|||Scores on a scale||Standard Deviation|Mean
1288406|NCT00143598|Secondary|Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding||During 2-year follow up||||participants|||Number
1288407|NCT00143598|Secondary|Severity of PTS, Including Incidence of Venous Ulcer|"Highest Villalta at or after 6 month visit~The Villalta Scale for assessment of the post-thrombotic syndrome The Villalta scale has a range of 0-33. A Villalta scale score >4 indicates post-thrombotic syndrome (severity of post-thrombotic syndrome is categorized as 5-9 points, mild; 10-14 points, moderate; >14 points or presence of an ulcer, severe).~Higher values signify worse outcome. Points on each item in the scale are simply summed to a total score."|6-24 months.|Highest Villalta score at or after 6 month visit (missing for 48 patients in each group).|||participants|||Number
1288408|NCT00143598|Primary|Incidence of Post-thrombotic Syndrome (PTS)||During 2-year follow up|Intention to treat.|||participants|||Number
1288409|NCT00143507|Secondary|Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction||From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.||||participants|||Number
1288410|NCT00143507|Secondary|Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.||||participants|||Number
1288411|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.||||participants|||Number
1288412|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.||||participants|||Number
1288413|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.||||participants|||Number
1288414|NCT00143507|Secondary|Hospitalisation for Unstable Angina||From the date of randomisation to the date of first occurrence of the event, up to 3 years.||||participants|||Number
1288415|NCT00143507|Secondary|Hospitalisation for Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the event, up to 3 years.||||participants|||Number
1288416|NCT00143507|Secondary|Coronary Artery Disease Death|Death due to heart failure, acute myocardial infarction or cardiac procedure|From the date of randomisation to death, up to 3 years.||||participants|||Number
1288417|NCT00143507|Secondary|All-cause of Mortality||From the date of randomisation to death, up to 3 years.||||participants|||Number
1288418|NCT00143507|Secondary|Hospitalisation for New Onset or Worsening Heart Failure||From the date of randomisation to the date of first occurrence of the event, up to 3 years.||||participants|||Number
1288419|NCT00143507|Secondary|Hospitalisation for Acute Myocardial Infarction||From the date of randomisation to the date of first occurrence of the event, up to 3 years.||||Participants|||Number
1288420|NCT00143507|Secondary|Cardiovascular Death|Cardiovascular death including sudden death of unknown cause|From the date of randomisation to death, up to 3 years.||||participants|||Number
1288421|NCT00143507|Primary|Primary Composite Endpoint|First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).|From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.||||participants|||Number
1288422|NCT00143455|Secondary|Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics)|Improvement of ≥ 1 tumor related symptom = clinical benefit responder. Pain improvement = decrease of ≥ 1 National Cancer Institute (NCI) grade from baseline of ≥ 1 symptom of NCI pain category, without pain symptom worsening. Cough, dyspnea and hemoptysis improvement = decrease of ≥ 1 NCI grade from baseline. Positive weight change ≥ 5 percent gain from baseline. Positive analgesic consumption = change from baseline from opioid to non-opioid category.|Every 3 weeks for up to 6 months on study treatment|Data were not analyzed.|||participants|||Number
1288492|NCT00142168|Secondary|Major Response Rate|Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a >50% reduction in serum IgM levels.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.|||participants|||Number
1288423|NCT00143455|Secondary|European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)|The EORTC QLQ-C30 scales include 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/QL scale and 9 symptom scales: nausea and vomiting, pain, fatigue, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QL represents a high QL (better patient state), and for a symptom scale/item represents a high level of symptomatology/problems (worse patient state).|Baseline, at every cycle (Day -1, Day 1 of cycle before treatment), at the end of the treatment, and every 2 months during follow-up|Data were not analyzed.|||scores on a scale||Standard Deviation|Mean
1288424|NCT00143455|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from date of randomization to the date of the first documentation of tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of progression (every 9 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment until progression)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.|||months||95% Confidence Interval|Median
1288425|NCT00143455|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)|FAP = Full analysis population (all treated patients) of Cohort 2 (after the 29 September 2003 protocol amendment), analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer.|||months||95% Confidence Interval|Median
1288426|NCT00143455|Primary|Overall Survival for the Per Protocol (PP) Population|OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)|PP population = a subset of the Cohort 2 FAP. The subjects had to be eligible (subject had no major protocol deviations from inclusion and noninclusion criteria), evaluable for response, without any major protocol deviations during the study.|||months||95% Confidence Interval|Median
1288427|NCT00143455|Secondary|Number of Subjects With Overall Confirmed Response|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.|||participants|||Number
1288428|NCT00143455|Primary|Overall Survival (OS) for the Full Analysis Population (FAP)|OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.|||months||95% Confidence Interval|Median
1288429|NCT00143403|Secondary|Overall Survival Rates|Probability of being alive was calculated in a yearly increment.|Median follow-up time (42 months)|Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).|||survival rate|||Number
1288430|NCT00143403|Primary|Disease Free Survival (DFS)|time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.|last tumor assessment date or cut-off date, whichever is earlier.|Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).|||months||95% Confidence Interval|Median
1288431|NCT00143390|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.|||months||95% Confidence Interval|Median
1288433|NCT00143390|Secondary|Number of Participants With Clinical Benefit - Investigator Assessment|Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.|||participants|||Number
1288434|NCT00143390|Secondary|Number of Participants With Objective Response - Investigators Assessment|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.|||participants|||Number
1288435|NCT00143390|Secondary|Time to Progression (TTP) - Investigators Assessment|Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.|||months||90% Confidence Interval|Median
1288436|NCT00143390|Primary|Time to Progression (TTP) - Expert Evaluation Committee Assessment|Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.|||months||95% Confidence Interval|Median
1288437|NCT00143312|Secondary|Survival Without Proven or Probable Invasive Fungal Infection (IFI)|Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits|6 months, 12 months|Complete case analysis using MITT population (ie, all subjects who had at least 1 dose of study medication & at least 1 post-enrollment efficacy assessment & a previous diagnosis of proven or probable IFI, confirmed by Data Review Committee) & either provided an IFI assessment at follow-up visit, died or experienced an IFI before that visit.|||participants|||Number
1288438|NCT00143312|Secondary|Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)|Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Two subjects experienced a recurrent proven or probable IFI.|||days|||Number
1288439|NCT00143312|Secondary|Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)|Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. One subject in the MITT population experienced a new IFI.|||days|||Number
1288440|NCT00143312|Secondary|Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)|Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Three subjects in the MITT population experienced an IFI.|||days|||Number
1288441|NCT00143312|Secondary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit|150 days|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).|||participants|||Number
1288442|NCT00143312|Secondary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up|6 months|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).|||participants|||Number
1288443|NCT00143312|Primary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up|12 months|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).|||participants|||Number
1288444|NCT00143247|Primary|Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment|Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||mL/min/mm Hg||Standard Deviation|Mean
1288445|NCT00143247|Secondary|Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment|Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.|6 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||participants|||Number
1288446|NCT00143247|Secondary|Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment|Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.|3 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||participants|||Number
1288447|NCT00143247|Secondary|Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment|Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.|3 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||participants|||Number
1288448|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)|Observed values by duration of treatment.|6 to 120 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||percent binding||Full Range|Median
1288449|NCT00143247|Primary|Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment|Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|Baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||liters||Standard Deviation|Mean
1288450|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment – Subjects With Type 2 Diabetes (Using Insulin at Study Entry)|observed values by duration of treatment.|36 to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||percent binding||Full Range|Median
1288451|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes|Observed values by duration of treatment.|36 months to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||percent binding||Full Range|Median
1288452|NCT00143247|Secondary|Severe Hypoglycemic Event Rates by Interval of Exubera Treatment|Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled & uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose.|0-132 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||severe events / 100 subject-months|||Number
1288531|NCT00141778|Secondary|Time to Tracheal Extubation|It is the time in minutes that it took to extubate the patient after surgery.|It is the time (in minutes) from admission to the ICU until tracheal extubation|The intention-to-treat analysis included all patients who received any study medication.|||minutes||Standard Deviation|Mean
1288453|NCT00143247|Secondary|Hypoglycemic Event Rates by Interval of Exubera Treatment|Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled & uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms.|0 to 132 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||events / subject-month|||Number
1288454|NCT00143247|Secondary|Change in Glycosylated Hemoglobin by Duration of Exubera Treatment|Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|Baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||percent HbA1C||Standard Deviation|Mean
1288455|NCT00142935|Secondary|Non-fatal Overdose|Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews||||participants|||Number
1288456|NCT00142935|Secondary|Fatal Overdose|Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.|Within six months from release of incarceration||||participants|||Number
1288457|NCT00142935|Secondary|Drug Use|Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews||||participants|||Number
1288458|NCT00142935|Primary|HIV Risk Behaviors - Self Report|Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews||||participants|||Number
1288459|NCT00142935|Primary|Time to MMT Initiation Post Release Based on Clinic Chart Review|Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.|within 30 days post release from incarceration|Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis.|||days||Standard Deviation|Mean
1288460|NCT00142935|Primary|Treatment Engagement|Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.|within 30 days post release of incarceration|We assessed community methadone treatment clinic attendance of all enrolled participants based on clinic chart review.|||participants|||Number
1288461|NCT00142909|Secondary|Diastolic Blood Pressure||12 weeks||||mm Hg||Standard Deviation|Mean
1288462|NCT00142909|Secondary|Diastolic Blood Pressure||1 Week||||mm Hg||Standard Deviation|Mean
1288463|NCT00142909|Secondary|Systolic Blood Pressure||12 weeks||||mm Hg||Standard Deviation|Mean
1288464|NCT00142909|Primary|SOWS: the Subjective Opiate Withdrawal Scale|The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5‐point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/|12 weeks||||units on a scale||Standard Deviation|Mean
1288465|NCT00142909|Secondary|Systolic Blood Pressure||1 Week||||mm Hg||Standard Deviation|Mean
1288466|NCT00142909|Primary|SOWS: the Subjective Opiate Withdrawal Scale|The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5‐point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/|1 Week||||units on a scale||Standard Deviation|Mean
1288467|NCT00142818|Secondary|Naltrexone/Modafinil-treated Subjects Will Have Fewer Days of Cocaine Use, More Abstinent Days From Alcohol, and Fewer Heavy Drinking Days During the Follow up Period Compared to Placebo-treated Subjects.||4+13 weeks|||||||
1288468|NCT00142818|Secondary|Modafinil-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.||4+13 weeks|||||||
1288469|NCT00142818|Secondary|Naltrexone-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.||4+13 weeks|||||||
1288470|NCT00142818|Primary|Number of Days of Abstinence From Drinking and Number of Days of Clinically Significant Drinking (Measured by Timeline Follow Back at Week 14 and the 6-month Evaluation)||4+13 weeks|||||||
1288471|NCT00142818|Primary|Cocaine Use (Measured by Timeline Follow Back and Urine Screen at Week 14)||13 weeks||||number of cocaine negative urine samples||Standard Deviation|Mean
1288472|NCT00142792|Secondary|Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation|The AMAT assesses upper limb specific tasks and does not allow for compensation. The AMAT consists of 13 compound ADL tasks composed of 1 to 3 component tasks, with a total of 28 component tasks. Each task was rated on the functional ability ordinal scale from 0-5 and an average is calculated, so the final score remains 0-5, with higher scores indicating lesser activity limitation. Total range of reported data is between 0 and 5 because the average is reported. 0 refers to no function. 5 refers to normal function.|AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.|All cases, intent to treat|||units on a scale||95% Confidence Interval|Least Squares Mean
1288473|NCT00142792|Primary|Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure|"The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated."|FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.|All cases, intent-to-treat, adjusted for site|||units on a scale||95% Confidence Interval|Least Squares Mean
1288474|NCT00142597|Primary|Change in Mu-opioid Receptor Occupancy|Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd.|measured from baseline to week 5||||Unitless: binding potential is Bmax/Kd||Standard Deviation|Mean
1288475|NCT00142506|Primary|Assessment of Erectile Dysfunction|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).|Baseline, 6 months, 12 months, 24 months||||units on a scale||Inter-Quartile Range|Median
1288476|NCT00142415|Secondary|Number of Subjects With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and categorized according to RECIST v1.0 at baseline and at the end of every cycle (every 12 weeks) or after recovery from toxicity. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 9 months|The Evaluable Analysis Set comprises subjects who completed Cycle 1 (ie, received both 111-In-DOTA-cG250 and 177-Lu-DOTA-cG250) and had at least 1 post-baseline response assessment. The Evaluable Analysis Set includes 23 subjects who completed Cycle 1, 12 subjects who completed Cycle 2, and 4 subjects who completed Cycle 3.|||participants|||Number
1288477|NCT00142415|Primary|Radiation Absorbed Doses by Organ for 177-Lu-cG250|After each 177-Lu-cG250 administration, 3 whole-body scintigrams were acquired (directly after injection and 2-4 days and 5-7 days post-injection) and blood samples were drawn at 5, 30, 60, and 120 min, 2-4 days, and 5-7 days post-infusion. Estimated radiation absorbed doses were calculated according to the Medical Internal Radiation Dose scheme, which permits estimation of the factors required to calculate dose to one organ attributable to a source in another organ.|12 weeks|The Dosimetry Evaluable Analysis Set comprises all subjects who received at least 1 dose of 177-Lu-cG250.|||mGy/MBq||Standard Deviation|Mean
1288478|NCT00142415|Primary|Number of Subjects With Dose-limiting Toxicity (DLT) During Cycle 1|Subjects were monitored for AEs for ≥ 8 weeks after the last infusion of 177-Lu-DOTA-cG250 before dose escalation could be implemented. Toxicity was graded in accordance with the NCI CTCAE version 3.0. DLT was defined as the following treatment-related events: ≥ Grade 3 non-hematologic toxicity; ≥ Grade 4 hematologic toxicity (platelets < 25 × 10^9/L or leukocytes < 1.0 × 10^9/L) that persisted for > 4 weeks except anemia; thrombocytopenia < 10 × 10^9/L; clinically relevant myelotoxicity that required hospitalization and/or blood product transfusion (e.g., uncontrolled bleeding, infections that had to be treated clinically).|12 weeks|The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.|||participants|||Number
1288479|NCT00142415|Primary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the NCI CTCAE version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.|Up to 1 year|The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.|||participants|||Number
1288480|NCT00142298|Primary|Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]|"The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up.~Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated."|52 weeks,104 weeks|"In Group C: other feeder study reporting group, there were only 13 patients; hence, no summary statistics were performed. Only listings were generated."||||||
1288512|NCT00141921|Secondary|Number of Participants With Grade 3 and 4 Laboratory Toxicities|The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.|264 weeks|Participants who received at least one dose of investigational product.|||participants|||Number
1288481|NCT00142298|Primary|Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]|The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks,104 weeks|The per protocol population. n= is the number of HBeAg-positive/HBeAg-negative patients from per protocol population who achieved maintained response at the end of treatment and had off-treatment assessment to determine the sustained response at that time point or lost sustained response before the off-treatment timepoint.|||Percentage of Participants||95% Confidence Interval|Number
1288482|NCT00142298|Primary|Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]|Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient’s baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.|52 weeks,104 weeks|Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.|||Percentage of Participants||95% Confidence Interval|Number
1288483|NCT00142298|Primary|Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]|Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient’s baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.|156 weeks, 208 weeks (from feeder study baseline)|Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.|||Percentage of Participants||95% Confidence Interval|Number
1288484|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks, 104 weeks|Per protocol (PP) population. The PP analysis was done on the PP population, separately for the HBeAg-positive and HBeAg-negative subpopulation (status as feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.|||Percentage of Participants||95% Confidence Interval|Number
1288485|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks, 104 weeks|Per protocol (PP) population. The PP analysis was done separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.|||Percentage of Participants||95% Confidence Interval|Number
1288486|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|156 weeks, 208 weeks (from feeder study baseline)|Per protocol (PP) population. The PP analysis was done on separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.|||Percentage of participants||95% Confidence Interval|Number
1288487|NCT00142298|Secondary|To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough||52 weeks, 104 weeks, 156 weeks, 208 weeks|||||||
1288488|NCT00142298|Secondary|To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients||52 weeks, 104 weeks, 156 weeks, 208 weeks|||||||
1288489|NCT00142298|Secondary|To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine||52 weeks, 104 weeks, 156 weeks, 208 weeks|||||||
1288490|NCT00142298|Secondary|To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment||52 weeks, 104 weeks, 156 weeks, 208 weeks|||||||
1288491|NCT00142168|Secondary|Minor Response Rate|A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.|||participants|||Number
1288513|NCT00141921|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs||264 weeks|Participants who received at least one dose of investigational product.|||participants|||Number
1288493|NCT00142168|Primary|Overall Response|Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.|||participants|||Number
1288494|NCT00142168|Primary|Time to Progression|Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.|34.3 months|All enrolled patients|||months||Full Range|Median
1288495|NCT00142116|Primary|Time to Progression|Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.|49.1 months||||months||Full Range|Median
1288496|NCT00142116|Secondary|To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.||3 years|||||||
1288497|NCT00142116|Primary|Objective Response Rate|Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).|3 years|Intent-to-treat basis|||participants|||Number
1288498|NCT00141921|Secondary|Improvement From Study 20030211 Baseline in Joint Pain|"Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10).~Improvement from baseline = (Baseline Value – Post-baseline Value)."|Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264|Participants who received at least one dose of investigational product and who completed the joint pain assessment at Study 20030211 baseline, and with available data at each time point.|||units on a scale||Standard Deviation|Mean
1288499|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
1288500|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
1288501|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
1288502|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
1288503|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
1288504|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
1288505|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in Children’s Dermatology Life Quality Index (CDLQI) Total Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but < 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data, and with available data at each time point.|||percent improvement||Standard Deviation|Mean
1288506|NCT00141921|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Clear (0) or Almost Clear (1)|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.|||percentage of participants|||Number
1288507|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in PASI Score|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.|||percent improvement||Standard Deviation|Mean
1288508|NCT00141921|Secondary|Percentage of Participants With a PASI 90 Response|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.|||percentage of participants|||Number
1288509|NCT00141921|Secondary|Percentage of Participants With a PASI 75 Response|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.|||percentage of participants|||Number
1288510|NCT00141921|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)|"A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product and with available data at each time point.|||percentage of participants|||Number
1288511|NCT00141921|Secondary|Number of Participants Who Developed Anti-etanercept Antibodies|"Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay.~Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline."|264 weeks|Participants who received at least one dose of investigational product and had a post-baseline antibody result.|||participants|||Number
1294513|NCT00090545|Secondary|Geometric Mean for Exposure Area Under the Curve (AUC) 0-12|Geometric mean exposure for sorafenib.|0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose||||mg/L.h||95% Confidence Interval|Geometric Mean
1288514|NCT00141921|Secondary|Exposure-adjusted Adverse Event Rates|"The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period.~Exposure-adjusted event rate per 100 patient years = total number of events / patient years * 100.~Multiple occurrences of the same event for a participant were counted as multiple events."|264 weeks|Participants who received at least one dose of investigational product.|||events per 100 patient years|||Number
1288515|NCT00141921|Secondary|Number of Participants With Injection Site Reactions|An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.|264 weeks|Participants who received at least one dose of investigational product.|||participants|||Number
1288516|NCT00141921|Primary|Number of Participants With Adverse Events|"A serious adverse events is any AE that~is fatal~is life threatening~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity).~An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer."|264 Weeks|Participants who received at least one dose of investigational product.|||participants|||Number
1288517|NCT00141817|Primary|Plasma Concentrations After Multiple Doses||Hours 2 and 4 on Day 7|Multiple-Dose Valid-for-Evaluation Population: Randomized participants who had concentration evaluations of pantoprazole either at 2 hours or at 4 hours after single dose and after at least 5 consecutive doses. n=participants who had data available at that specific time point.|||ng/mL||Standard Deviation|Mean
1288518|NCT00141817|Primary|Terminal-Phase Volume of Distribution (Vz/F)|Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||liter per kilogram (L/kg)||Standard Deviation|Mean
1288519|NCT00141817|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||liter per hour per kilogram (L/h/kg)||Standard Deviation|Mean
1288520|NCT00141817|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||hours||Standard Deviation|Mean
1288521|NCT00141817|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||ng*h/mL||Standard Deviation|Mean
1288522|NCT00141817|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population.|||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
1288523|NCT00141817|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||hours||Standard Deviation|Mean
1288524|NCT00141817|Primary|Maximum Observed Plasma Concentration (Cmax)||Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population: Randomized participants who took 1 dose of pantoprazole and had at least 4 single-dose blood samples for pharmacokinetic (PK) analyses.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1288525|NCT00141778|Secondary|Perioperative C-reactive Protein (CRP) Concentrations|C-reactive protein was measured at several time points (see table) over the course of the study.|Perioperative period|CRP was measured in all subjects from the intention-to-treat analysis for which plasma was available at those time points.|||ug/mL||Standard Deviation|Mean
1288526|NCT00141778|Secondary|Perioperative Plasminogen Activator Inhibitor-1 (PAI-1) Concentrations|Plasminogen activator inhibitor-1 (PAI-1) was measured at several time points (see table) over the course of the study.|Perioperative period|PAI-1 was measured in all subjects in the intention-to-treat analysis for which plasma was available.|||ng/mL||Standard Deviation|Mean
1288527|NCT00141778|Secondary|Perioperative Interleukin(IL)-6 Concentrations|Interleukin-6 was measured at several time points (see time points in table) over the course of the study|Perioperative period|All participants included in the intention-to-treat analysis who had available plasma samples.|||pg/ml||Standard Deviation|Mean
1288528|NCT00141778|Secondary|Stroke|Percentage of patients in each study group who experience a cerebrovascular event, confirmed by CT.|Measured until the time of hospital discharge, from 5.7 to 6.8 days on average depending on the study arm.|The intention-to-treat analysis included all those who received any study drug.|||percentage of patients|||Number
1288529|NCT00141778|Secondary|Death|The percentage of patients in each study arm who died.|Measured until the time of hospital discharge|The intention-to-treat analysis included all patients who received any study medication.|||percentage of patients|||Number
1288530|NCT00141778|Secondary|Length of Hospital Stay (Days)||Measured from the day of surgery until the time of hospital discharge|The intention-to-treat analysis included anyone who had received any study medication.|||days||Standard Deviation|Mean
1288532|NCT00141778|Secondary|Hypokalemia|Percentage of patients who had a serum potassium concentrations <3.5 milliequivalents (mEq)/L|Measured until the time of hospital discharge, which was an average of 5.7 to 6.8 days depending on the treatment arm.||||percentage of patients|||Number
1288533|NCT00141778|Secondary|Hypotension|Percentage of patients with hypotension defined as a systolic blood pressure <90 mmHg and/or prolonged requirement for vasopressor use.|Measured during and after surgery, until discharge, from 5.7 to 6.8 days on average.|The intention-to-treat analysis included anyone who had received any medication.|||percentage of patients|||Number
1288534|NCT00141778|Secondary|Acute Renal Failure|Percentage of patients with a creatinine concentrations >2.5mg/dl|Measured until the time of hospital discharge, from 5.7 to 6.8 days on average, depending on the study group.|The intention-to-treat analysis included anyone who had received any study medication.|||percentage of patients|||Number
1288535|NCT00141778|Primary|Postoperative Atrial Fibrillation|The primary endpoint of the study was the percentage of patients with electrocardiographically confirmed AF of at least 10 secs duration at any time following the end of surgery until hospital discharge, an average from 5.7 days in the ramipril group to 6.8 days in the placebo group. Patients were monitored continuously on telemetry throughout the postoperative period until discharge. Electrocardiograms were obtained for any rhythm changes detected on telemetry monitoring, and in addition, electrocardiograms were performed preoperatively, at admission to the intensive care unit, and daily starting on postoperative day 1. All electrocardiograms and rhythm strips were reviewed in a blinded fashion by a single cardiac electrophysiologist.|Measured from admission to the ICU until discharge from hospital|Four hundred fifty-eight patients were randomized. Of these 445 took study medication and were included in the intention-to-treat analysis.|||percentage of patients|||Number
1288536|NCT00141765|Primary|Percent of Participants With Progression Free Survival at 1 Year|The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.|1 year post transplant||||percentage of participants|||Number
1288537|NCT00141739|Secondary|The Impact of Tumor Necrosis Factor (TNF) Polymorphisms on Response to Therapy.||100 days|This was not analyzed in the population and there are no plans to analyze this in the future. The study is complete and the principal investigator has left the institution.||||||
1288538|NCT00141739|Secondary|Day +7 TNFR1 Ratio in TBI-Treated Patients vs. Non-TBI-Treated Patients|The effect of etanercept on plasma cytokine levels after Hematopoietic Stem Cell Transplantation (HSCT) was analyzed. Tumor Necrosis Factor Receptor 1 (TNFR1) ratios (TNFR1 posttransplantation day+7 / TNFR1pretransplantation baseline were calculated. Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.|Day+7, post transplant|TBI versus non-TBI transplant conditioning|||TNFR1 Ratio||Full Range|Mean
1288539|NCT00141739|Secondary|The Number of Patients That Experience Idiopathic Pulmonary Syndrome (IPS)|The Effect of etanercept on the incidence of idiopathic pulmonary syndrome (IPS). Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.|100 days|TBI versus Non-TBI transplant conditioning|||Participants|||Count of Participants
1288540|NCT00141739|Secondary|Number of Patients Experiencing Etanercept Toxicity|Toxicity of etanercept was evaluated by the following: the number of patients experiencing allergic reactions, the number of patients that discontinued etanercept early, the number of patients experiencing bacteremia, and the number of patients experiencing viral reactivations.|100 days||||participants|||Number
1288541|NCT00141739|Primary|The Percentage of Participants Experiencing Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|"In order to determine whether etanercept, given prophylactically along with a standard Graft Versus Host Disease (GVHD) prevention regimen, will decrease the 100-day mortality and the rate of acute GVHD after allogeneic hematopoietic stem cell transplantation(HSCT), the incidence of grades 2-4 and grades 3-4 GVHD were calculated.~GVHD can be clinically graded as 0, I, II, III, or IV. Definition of grades are:~Grade 0 - No stage 1-4 of any organ Grade I - Stage 1-2 rash and no liver or gut involvement Grade II - Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gastrointestinal involvement Grade III - Stage 0-3 skin, with STage 2-3 liver, or Stage 2-3 gastrointestinal involvement Grade IV - Stage 4 skin, liver, or gastrointestinal involvement"|100 days|To provide Sufficient power|||percentage of participants|||Number
1288542|NCT00141726|Secondary|Percentage of Participants That Experience Grade 3 to 4 Adverse Events|To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury > 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.|continuously (and week 4, week 8 and week 12, week 20)|34 subjects were enrolled and evaluated for adverse events.|||percentage of participants|||Number
1288543|NCT00141726|Primary|Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO|Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .|week 12 post therapy|34 subjects were enrolled. Thirty-one of 34 subjects were evaluable for response, with three subjects completing <50% of scheduled dosing.|||percent evaluable participants|||Number
1288544|NCT00141518|Other Pre-specified|EQ-5D Visual Analog Scale (VAS) Score, up to Month 36|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288620|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 1: Single Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural­-logarithm transformed concentration-­time profile.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase||||||
1288545|NCT00141518|Other Pre-specified|EQ-5D Descriptive Systems Summary Index Score, up to Month 36|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288546|NCT00141518|Other Pre-specified|UPDRS Part IV Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288547|NCT00141518|Other Pre-specified|UPDRS Part III Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288548|NCT00141518|Other Pre-specified|UPDRS Part II Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288549|NCT00141518|Other Pre-specified|UPDRS Part I Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288550|NCT00141518|Other Pre-specified|UPDRS Total Score up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288551|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1294514|NCT00090545|Secondary|Maximum Observed Plasma Concentration (Cmax) of BAY 43-9006 (Sorafenib)|Plasma concentration-time profile for sorafenib.|0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, AND 24 hours post dose||||mg/L||Full Range|Mean
1288552|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed’ is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. ‘Tapping random chase – accuracy’ is the percentage of accurate random chase taps.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of accurate taps||Standard Deviation|Mean
1288553|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed’ is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||taps/20 seconds||Standard Deviation|Mean
1288554|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Tapping at increased speed - accuracy’ is the percentage of accurate taps per all taps on computer-generated fields.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of accurate taps||Standard Deviation|Mean
1288555|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Free tapping’ is defined as ____. ‘Free tapping accuracy’ is the percentage of accurate free taps per 20 seconds(?).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of tapping accuracy||Standard Deviation|Mean
1288556|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed’ is a count of the number of taps per 20 seconds.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||taps/20 seconds||Standard Deviation|Mean
1288557|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Self-assessment’ scores were -3 (Off) to +3 (dyskinetic). ‘Off’ time is when PD symptoms are not adequately controlled by the drug. ‘Dyskinetic’ time is time with involuntary muscle movement. “0” is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to “0” means improvement, everything more away from “0” means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288558|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Satisfied with function’ scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288559|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Cramps’ scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288560|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Dyskinetic time’ is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288561|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Off time’ is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288562|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Dyskinetic time’ is time with involuntary muscle movement, and is represented as a percentage of total time of the last __ hours.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of 'dyskinetic' time||Standard Deviation|Mean
1288563|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. On time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last __ hours."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of 'on' time||Standard Deviation|Mean
1288576|NCT00141518|Secondary|MADRS Pessimistic Thoughts Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288564|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Off time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of 'off' time||Standard Deviation|Mean
1288565|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288566|NCT00141518|Secondary|PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288567|NCT00141518|Secondary|PDQ-39 Communication Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288568|NCT00141518|Secondary|PDQ-39 Cognition Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288569|NCT00141518|Secondary|PDQ-39 Social Support Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288570|NCT00141518|Secondary|PDQ-39 Stigma Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288571|NCT00141518|Secondary|PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288572|NCT00141518|Secondary|PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288573|NCT00141518|Secondary|PDQ-39 Mobility Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288574|NCT00141518|Secondary|Parkinson’s Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288575|NCT00141518|Secondary|MADRS Suicidal Thoughts Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288806|NCT00140140|Secondary|Kaplan-Meier Estimates for Participant Survival|Participant survival is the time from the first dose of study drug to participant death from any cause. Participants that did not die were censored at the last known time the participant was alive.|up to 39 months|Treated population|||months||95% Confidence Interval|Median
1288577|NCT00141518|Secondary|MADRS Inability to Feel Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288578|NCT00141518|Secondary|MADRS Lassitude Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288579|NCT00141518|Secondary|MADRS Concentration Difficulties Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288580|NCT00141518|Secondary|MADRS Reduced Appetite Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288581|NCT00141518|Secondary|MADRS Reduced Sleep Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288582|NCT00141518|Secondary|MADRS Inner Tension Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288583|NCT00141518|Secondary|MADRS Apparent Sadness Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288584|NCT00141518|Secondary|MADRS Reported Sadness Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1289723|NCT00128830|Primary|Number of Participants With Adverse Events|Number of participants who reported at least 1 of the adverse events.|Up to 3 years|Intent-to-treat population: Participants who received at least 1 dose of study medication were included|||Participants|||Number
1288585|NCT00141518|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288586|NCT00141518|Secondary|MMSE Language Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288587|NCT00141518|Secondary|MMSE Recall Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288588|NCT00141518|Secondary|MMSE Attention and Calculation Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288589|NCT00141518|Secondary|MMSE Registration Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288590|NCT00141518|Secondary|MMSE Orientation Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288591|NCT00141518|Secondary|Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)|Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.|||units on a scale||Standard Deviation|Mean
1288592|NCT00141518|Secondary|"Schwab and England Scale: Best On Period Stage From Baseline to Month 36"|"The Schwab and England scale was used to rate the subject’s best “on” period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). On time is when PD symptoms are well controlled by the drug."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage score on a scale||Standard Deviation|Mean
1288619|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 8: Multiple Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm transformed concentration-time profile.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate the data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase.||||||
1288593|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36|The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288594|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36|The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288595|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36|The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288596|NCT00141518|Primary|Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010|Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability – is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36|All participants; n=fraction of number of participants younger than 65 years with indirect costs / number of participants assessed at given time point.|||SEK 2010||Standard Deviation|Mean
1288597|NCT00141518|Primary|Direct Monthly Non-medical Costs Per Participant, SEK 2010|Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants||||SEK 2010|Participants|Standard Deviation|Mean
1288598|NCT00141518|Primary|Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010|Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants||||SEK 2010|Participants|Standard Deviation|Mean
1288599|NCT00141518|Primary|Monthly Drug Costs Per Participant, SEK 2010|Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants||||SEK 2010|Participants|Standard Deviation|Mean
1288600|NCT00141518|Primary|Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010|"Total monthly costs include~Direct medical costs (inpatient care, outpatient care, and drug costs [including Duodopa cost and cost of concomitant anti-PD medication]).~Direct non-medical costs (nursing home, home help, personal assistance, informal care [from family member or friend] and transportation to inpatient, outpatient visits and nursing home).~Indirect costs (sick-leave and early retirement due to PD [applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden]).~The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK."|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants||||SEK 2010|Participants|Standard Deviation|Mean
1288601|NCT00141518|Primary|EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.|||units on a scale||Standard Deviation|Mean
1289186|NCT00135330|Secondary|Change in Fasting LDL Cholesterol|Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||mmol/L||Standard Error|Least Squares Mean
1288602|NCT00141518|Primary|Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288603|NCT00141518|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
1288604|NCT00141453|Secondary|Reciprocal (1/Serum Creatinine) of Serum Creatinine|The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.|Randomization to 5 years|Full analysis set=566|||dL/mg/year||Inter-Quartile Range|Median
1288605|NCT00141453|Secondary|The Change in Proteinuria|The median percentage change from baseline value in urinary protein:creatinine ratio|Randomization to 5 years|Full analysis set=566|||Median percentage change in ratio|||Number
1288606|NCT00141453|Secondary|Number of Participants Experiencing Cardiovascular Composite Outcomes|Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.|Within 5 years|Full analysis set=566|||participants|||Number
1288607|NCT00141453|Primary|Renal Composite Outcomes|first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease|Randomization to 5 years|Full analysis set=566|||participants|||Number
1288608|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With Tumor Response|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with tumor response.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.||||||
1288609|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With Exposure|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with PD 0322991 exposure.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.||||||
1288610|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With PD 0322991 Dose|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with respect to PD 0322991 dose.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.||||||
1288611|NCT00141297|Primary|Inhibition of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) Based on Phosphorylated Retinoblastoma (p-Rb) in Tumor Tissue|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue and p-Rb levels (fold decrease) were to be reported.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.||||||
1288695|NCT00141271|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.|Baseline to 6 weeks|Intent to treat (ITT) population observed cases|||score on scale||Standard Error|Least Squares Mean
1288612|NCT00141297|Primary|Number of Participants With Best Response|Number of participants with best response. Complete response (CR): disappearance of all target and non-target lesions. Partial Response (PR): >=30% decrease in sum of longest diameter (LD) of lesions taking as reference baseline sum LD and no unequivocal progression in non-target lesions. Progressive disease (PD): >=20% increase in sum of LD of lesions taking as a reference smallest sum of the LD since treatment start, or the appearance of >=1 new lesion or unequivocal progression of existing non-target lesions. Stable disease (SD): neither shrinkage for PR nor increase for PD taking as reference smallest sum of LD since treatment start. SD was assessed following the first 2 cycles of treatment (>=2 cycles), 4 cycles of treatment (>=4 cycles), and 10 cycles of treatment (>=10 cycles). Participants may be reported in more than 1 category of SD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline up to end of treatment, assessed at C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Modified Full Analysis Set included all enrolled participants who received at least 1 dose of study medication in Cycle 1 and completed a post-treatment response assessment.|||participants|||Number
1288613|NCT00141297|Primary|Percent Dose Recovered Unchanged (Percent Ae) in Urine: Food Effect|The percent Ae is defined in Outcome Measure 44. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|Data was not collected because urine PK was not planned to be analyzed by food effect, as per protocol.||||||
1288614|NCT00141297|Primary|Percent Dose Recovered Unchanged in Urine (Percent Ae): Single Dose|Percent of dose recovered unchanged in urine over the 10 hour collection interval=100*(Ae divided by dose). Ae is the cumulative amount of drug recovered unchanged in urine over the 10 hour collection interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||percentage of dose||Standard Deviation|Mean
1288615|NCT00141297|Primary|Cumulative Amount of Drug Recovered Unchanged in the Urine (Ae): Food Effect|The Ae is defined in Outcome Measure 42. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|Data was not collected because urine PK was not planned to be analyzed by food effect, as per protocol.||||||
1288616|NCT00141297|Primary|Cumulative Amount of Drug Recovered Unchanged in the Urine (Ae): Single Dose|Ae is the cumulative amount of drug recovered unchanged in urine over the 10 hour collection interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Urine PK analysis was performed only in the MTD/RP2D groups (125 mg [21/28 Days] and 200 mg [14/21 Days]).|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||microgram (mcg)||Standard Deviation|Mean
1288617|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 1: Food Effect|Terminal phase rate constant: absolute value of slope of a linear regression during terminal phase of natural-logarithm transformed concentration-time profile. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate the data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase.||||||
1288618|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm transformed concentration-time profile. The mean lambda (z) for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||1/hour||Standard Deviation|Mean
1295361|NCT00082810|Secondary|Duration of Response|DOR was defined for responders as the time from the onset of first response to disease progression and for non-responders as zero|Up to 4 years||||months||95% Confidence Interval|Median
1288621|NCT00141297|Primary|Accumulation Ratio (Rac) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Rac at Day 14/21 = AUC (0-tau) at Day 14/21 divided by AUC (0-tau) at Day 1. The mean Rac for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
1288622|NCT00141297|Primary|Accumulation Ratio (Rac) on Day 8: Multiple Dose|Rac at Day 8 = AUC (0-tau) at Day 8 divided by AUC (0-tau) at Day 1.|Hour 0 (pre-dose), 1, 2, 4, 7, 10, and 24 hours post-dose on C1D1 and C1D8|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Rac.||||||
1288623|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 1: Food Effect|Volume of distribution: theoretical volume in which total amount of drug would need to be uniformly distributed to produce desired plasma concentration. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.||||||
1288624|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. The mean Vz/F for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||liter||Standard Deviation|Mean
1288625|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 8: Multiple Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.||||||
1288626|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 1: Single Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.||||||
1288627|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 1: Food Effect|Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.||||||
1288653|NCT00141297|Primary|Number of Participants With Treatment Emergent Adverse Events Categorized by Severity|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. For clinical description of nature (severity) of AEs, AEs were grades as: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; and Grade 5: death related to AE. AEs during Cycle 1 and AEs post Cycle 1 are reported separately.|Cycle 1, Cycle 2 up to 28 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1288628|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. The mean CL/F for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||liter/hour||Standard Deviation|Mean
1288629|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 8: Multiple Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.||||||
1288630|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 1: Single Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.||||||
1288631|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 1: Food Effect|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).||||||
1288632|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 8: Multiple Dose|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).||||||
1288633|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 1: Single Dose|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).||||||
1288634|NCT00141297|Primary|Area Under the Curve From Time Zero to End of the Dosing Interval [AUC(0 to Tau)] on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Area under the curve from time zero to end of the dosing interval (24 hours) [AUC (0-tau)]. The mean AUC (0-tau) for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng*hour/mL||Standard Deviation|Mean
1288654|NCT00141297|Primary|Number of Dose-Limiting Toxicities (DLTs) Categorized as Per the Nature|DLT is defined in Outcome Measure 1. Hematologic (Grade 4 [life-threatening or disabling]) and non-hematologic (Grade 3 [severe], 4 [life-threatening and disabling], 5 [resulting in death]) DLTs are reported separately. A single participant may experience more than one DLT. Both treatment-related and treatment-unrelated DLT events were reported for this outcome measure.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.|||DLTs|||Number
1289300|NCT00133952|Secondary|Time to Focal Photocoagulation||Baseline through 48 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.|||months||95% Confidence Interval|Median
1288635|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 1: Food Effect|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng*hour/mL||Standard Deviation|Mean
1288636|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). The mean AUClast for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng*hour/mL||Standard Deviation|Mean
1288637|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 8: Multiple Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng*hour/mL||Standard Deviation|Mean
1288638|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 1: Single Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day.|||nanogram*hour/milliliter (ng*hour/mL)||Standard Deviation|Mean
1288639|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 1: Food Effect|To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.||||||
1288640|NCT00141297|Primary|Terminal Half-life (t½) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half. The mean t1/2 for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
1288641|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 8: Multiple Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.||||||
1288642|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 1: Single Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.||||||
1288655|NCT00141297|Primary|Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose Level (RP2D)|MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was <33%. Once MTD was determined, it was defined as RP2D. DLT is defined in Outcome Measure 1.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.|||milligram|||Number
1288667|NCT00141271|Secondary|Change in Digit Sequencing Task at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases|||Number Correct||Standard Error|Least Squares Mean
1288643|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1: Food Effect|To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||hours||Full Range|Median
1288644|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|The median Tmax for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||hours||Full Range|Median
1288645|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 8: Multiple Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||hours||Full Range|Median
1288646|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1: Single Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
1288647|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1: Food Effect|To determine the impact of food (specifically a high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In this crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. The first 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, the next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. The high-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of the total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1288648|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|The mean Cmax for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1288649|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 8: Multiple Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1288650|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1: Single Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|Pharmacokinetic (PK) analysis set included all participants from FAS who had completed PK blood sampling for at least one day.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1288651|NCT00141297|Primary|Number of Participants Who Died Due to Adverse Event on the Basis of Relatedness to Study Drug|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness [to study drug] was assessed by the investigator (Yes/No).|Baseline up to 30 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1288652|NCT00141297|Primary|Number of Participants With Treatment-Related Treatment Emergent Adverse Events|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs during Cycle 1 and AEs post Cycle 1 are reported separately.|Cycle 1, Cycle 2 up to 28 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1288828|NCT00139776|Secondary|Physician's Global Assessment of Arthritis at Final Visit|Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication|||participants|||Number
1288656|NCT00141297|Primary|Maximum Administered Dose (MAD)|Three new evaluable participants were to be assessed at each new dose level. The minimum time that these participants were to be followed after starting treatment was 1 cycle (28 or 21 days) before a new dose level could be opened. If none of these 3 participants experienced a DLT, the next higher dose level was to be opened on that schedule. If 1 participant developed a DLT, 3 more evaluable participants were to be enrolled at that dose level; if none of these additional 3 participants developed a DLT, the next higher dose level was to be opened on that schedule. If >=2 participants experienced a first cycle DLT at the same dose level and schedule, that dose level was to be defined as the MAD for that schedule. No additional participants were to be entered at the MAD for that dosing schedule. DLT is defined in Outcome Measure 1.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.|||milligram|||Number
1288657|NCT00141297|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|DLT: an adverse event occurring after initiation of PD 0332991 that met any following criteria: 1) Grade 4 hematologic toxicity (platelets less than [<] 25000 per microliter (mcL), absolute neutrophil count [ANC] <500/mcL, hemoglobin [Hb] <6.5 gram per deciliter [g/dL]; 2) ANC <1000/mcL associated with documented infection or fever greater than or equal to (>=) 38.5 degrees Celsius; 3) >=Grade 3 non-hematologic treatment-related toxicity. In an asymptomatic participant, Grade 3 corrected QT (QTc) prolongation (>500 millisecond) (only if persisted with repeat testing and after correction of reversible causes [electrolyte abnormalities or hypoxia]); and 4) Inability to receive next dose of PD 0332991 within 1 week (+/-1 day) of last dose due to lack of hematologic recovery (platelets <50000/mcL, ANC <1000/mcL, and Hb <8.0 g/dL) or due to prolonged non-hematologic toxicities of >=Grade 3 severity. Occurrence of a DLT necessitated immediate interruption of scheduled study treatment.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1288658|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
1288659|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
1288660|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
1288661|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6|||Words||Standard Error|Least Squares Mean
1288662|NCT00141271|Secondary|Change in Tower of London Test at Endpoint|Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
1288663|NCT00141271|Secondary|Change in Symbol Coding at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Total Correct||Standard Error|Least Squares Mean
1288664|NCT00141271|Secondary|Change in Verbal Fluency Controlled Word Association at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
1288665|NCT00141271|Secondary|Change in Verbal Fluency in Naming Categories at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
1288666|NCT00141271|Secondary|Change in Token Motor Task at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number of Tokens||Standard Error|Least Squares Mean
1288917|NCT00138424|Secondary|Allograft Rejection.|Allograft rejection is the number of subjects that rejected their kidney by the end of the study.|Day 49.|Number of rejections|||Participants|||Number
1288668|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
1288669|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
1288670|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases|||words||Standard Error|Least Squares Mean
1288671|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
1288672|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
1288673|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
1288674|NCT00141271|Secondary|Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases|||words||Standard Error|Least Squares Mean
1288675|NCT00141271|Secondary|Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases|||words||Standard Error|Least Squares Mean
1288676|NCT00141271|Secondary|Change in Verbal Memory Trial Performance Total Score at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall.|Baseline to 6 Weeks LOCF|Intent to Treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
1288677|NCT00141271|Secondary|Change in Sleep Disturbance Factor Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12.|Baseline to 6 weeks|ITT Population Observed cases|||score on scale||Standard Error|Least Squares Mean
1288678|NCT00141271|Secondary|Change in Retardation Factor Scores|Change is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16.|Baseline to 6 Weeks||||score on scale||Standard Error|Least Squares Mean
1288679|NCT00141271|Secondary|Change in Anxiety/Somatizations Factor Total Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24.|Baseline to 6 Weeks|ITT Population Observed Cases|||score on scale||Standard Error|Least Squares Mean
1288680|NCT00141271|Secondary|Change in Bech Melancholia Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24.|Baseline to 6 Weeks|ITT Population Observed cases|||score on scale||Standard Error|Least Squares Mean
1288681|NCT00141271|Secondary|Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint|Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80|Baseline to 6 Weeks|ITT Population Observed Cases.n= 142, 137, 139; number of subjects who responded to the scale. Endpoint is LOCF endpoint among Week 1 through Week 6.|||score on scale||Standard Error|Least Squares Mean
1288682|NCT00141271|Secondary|Change in Sheehan Disability Scale (SDS) Total Score at Endpoint|Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30.|Baseline to Week 6|ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 - 6; n= 128, 126, 128; number of subjects who responded to the scale.|||score on scale||Standard Error|Least Squares Mean
1288683|NCT00141271|Secondary|Response as Measured by CGI-I Score Less Than or Equal to 2|Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse|Week 1 through Week 6 (endpoint)|"ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.~Not all subjects answered each week."|||Participants|||Number
1288684|NCT00141271|Secondary|Change in Total Score in Hamilton Depression (HAM-D 25)|Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72.|Baseline to 6 Weeks|ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||score on scale||Standard Error|Least Squares Mean
1288685|NCT00141271|Secondary|Change in Global Clinical Improvement of Symptoms (CGI -I)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse|Baseline to 6 weeks|ITT population Observed Cases|||score on scale||Standard Error|Least Squares Mean
1288686|NCT00141271|Secondary|Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill|Baseline to 6 weeks|ITT population Observed Cases|||score on scale||Standard Error|Least Squares Mean
1288687|NCT00141271|Secondary|Change in Total Score of Young Mania Rating Scale (YMRS)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 0 to 4 for 7 items and 0 to 8 for 4 items; 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.|Baseline to 6 weeks|ITT Population|||score on scale||Standard Error|Least Squares Mean
1288688|NCT00141271|Secondary|Change in Hamilton Anxiety Rating (HAM-A)|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56.|Baseline to 6 weeks|ITT population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6|||score on scale||Standard Error|Least Squares Mean
1288689|NCT00141271|Secondary|Change in Hamilton Depression (HAM-D 17) Total Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52.|Baseline to 6 weeks|ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||score on scale||Standard Error|Least Squares Mean
1288690|NCT00141271|Secondary|Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7|Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.|Baseline to 6 weeks|"ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each week."|||Participants|||Number
1288691|NCT00141271|Secondary|Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12|Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal)|Baseline to 6 weeks|"ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6;~Not all subjects answered each week."|||participants|||Number
1288692|NCT00141271|Secondary|Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)|Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality|Baseline, 6 Weeks LOCF|Intent to treat (ITT) population observed cases, Last Observation Carried Forward (LOCF).|||score on scale||Standard Error|Least Squares Mean
1288693|NCT00141271|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.|Baseline to 6 weeks|"Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each Week."|||participants|||Number
1288694|NCT00141271|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score|Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60|Baseline to 6 weeks|"Intent to treat (ITT) population observed cases.~Not all subjects answered at each Week"|||Participants|||Number
1288932|NCT00138203|Secondary|Toxicity|Number of participants experiencing adverse events possibly related to SAHA from first dose of treatment until 30 days from the last dose of treatment.|From first dose of treatment until 30 days from the last dose of treatment||||Participants|||Count of Participants
1288696|NCT00141219|Secondary|Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score|DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 observations while on study medication were carried forward (LOCF).|||score on scale||Standard Deviation|Mean
1288697|NCT00141219|Secondary|Clinical Global Impression of Change (CGIC)|CGIC is a clinician-rated instrument that assesses the subject’s overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. CGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||participants|||Number
1288698|NCT00141219|Secondary|Patient Global Impression of Change (PGIC)|PGIC is a subject-rated instrument that measured change in subject’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. PGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||participants|||Number
1288699|NCT00141219|Secondary|Hospital Anxiety and Depression Scale- Depression (HADS-D) Score|HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (“lowering of hedonic tone”). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288700|NCT00141219|Secondary|Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score|HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288701|NCT00141219|Secondary|Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS)|EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) & Visual Analog Scale (VAS)). The VAS is designed to rate the subject’s current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288702|NCT00141219|Secondary|Euro Quality of Life (QOL) (EQ-5D) Utility Score|EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject’s level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort & anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best).|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288703|NCT00141219|Secondary|Medical Outcome Study (MOS) Overall Sleep Problems Index|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288704|NCT00141219|Secondary|Medical Outcome Study (MOS) Somnolence|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288705|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Adequacy|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288706|NCT00141219|Secondary|Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||participants|||Number
1288707|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Quantity|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288708|NCT00141219|Secondary|Medical Outcome Study (MOS) Awaken Short of Breath or Headache|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288709|NCT00141219|Secondary|Medical Outcome Study (MOS) Snoring Score|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288710|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Disturbance|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
1288711|NCT00141219|Secondary|Mean Sleep Score as Computed by DSIS.|DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average.|Weeks 1 to 8|ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n = (pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1288712|NCT00141219|Secondary|Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS).|DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance.|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily sleep interference scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.|||score on scale||95% Confidence Interval|Least Squares Mean
1288713|NCT00141219|Secondary|Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score|DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Subjects without any post-baseline daily pain scores would have no DAAC; missing DAACs were not imputed.|||score on scale||95% Confidence Interval|Least Squares Mean
1288714|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score|DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n= (pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
1288715|NCT00141219|Other Pre-specified|Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population)|DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.|Endpoint- Week 8 or Early Discontinuation|"Evaluable (EVAL) Population: Subset of ITT subjects with ≥4 daily pain diaries in the 7 days before Visit 2 (randomization) with average score ≥4; ≥14 days of treatment; ≥14 days of DB daily pain diaries; not withdrawn due to Protocol violation or Did not meet entrance criteria; not previously participated in the study."|||score on scale||95% Confidence Interval|Least Squares Mean
1288716|NCT00141219|Primary|Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)|DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.|||score on scale||95% Confidence Interval|Least Squares Mean
1288717|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores)|DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline.|Endpoint- Week 8 or Early Discontination|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.|||participants|||Number
1288718|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores)|DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.|||participants|||Number
1288719|NCT00141115|Secondary|Percent of Drinking Days|daily drinking assessed each of study participation, reported percent of drinking days for 28 days prior to study initiation compared to last 28 days of study participation-as reported on the Time line follow back|assessed daily, reported for baseline 28 days compared to last 28 days of study participation||||percentage of days||Standard Deviation|Mean
1288720|NCT00141115|Primary|Participants Who Reported Reductions in Alcohol Consumption|Number of participants who reduced drinking during the trial|over 9 weeks of study or length of participation|Number of participants who were drinking less at the end of the study compared to the beginning.|||Participants|||Count of Participants
1288721|NCT00141102|Other Pre-specified|Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview|Interview occurred via telephone to obtain follow-up mortality and hospitalization information.|6 months following last dose|Safety population. Number of participants analyzed = number of subjects with follow-up information available.|||participants|||Number
1288722|NCT00141102|Other Pre-specified|Number of Subjects Alive at the Post Trial Interview|Interview occurred via telephone to obtain follow-up mortality and hospitalization information.|6 months following last dose|Safety population. Number of participants analyzed = number of subjects with follow-up information available.|||participants|||Number
1288723|NCT00141102|Secondary|Change From Baseline in C-Reactive Protein to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||mg/dL||Standard Error|Least Squares Mean
1288724|NCT00141102|Secondary|Change From Baseline in Ferretin to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||ug/dL||Standard Error|Least Squares Mean
1288725|NCT00141102|Secondary|Change From Baseline in Iron Binding Capacity to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||microgram (ug)/dL||Standard Error|Least Squares Mean
1288726|NCT00141102|Secondary|Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||IU/L||Standard Error|Least Squares Mean
1288727|NCT00141102|Secondary|Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)|GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.|6 month treatment duration|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||participants|||Number
1288728|NCT00141102|Secondary|Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin|A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.|6 month treatment duration|Safety population. Number of Participants Analyzed = number of subjects with analyzable data.|||participants|||Number
1288729|NCT00141102|Secondary|Change From Baseline in Hematocrit at Month 6/ET||Month 6/ET|Safety population. Number of Participants Analyzed = number of subjects with analyzable data.|||percent||Standard Error|Least Squares Mean
1288730|NCT00141102|Secondary|Change From Baseline in Hemoglobin at Month 6/ET||Month 6/ET|Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data.|||grams (g)/deciliter (dL)||Standard Error|Least Squares Mean
1288731|NCT00141102|Secondary|Number of Subjects Withdrawn Due to GI Adverse Events (AEs)|GI AEs were defined using MedDRA SOC “Gastrointestinal Disorders” but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.|6 month treatment duration|ITT|||participants|||Number
1288732|NCT00141102|Secondary|Number of Subjects With Moderate to Severe Abdominal Symptoms|"Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to “Gastrointestinal Signs and Symptoms."|6 month treatment duration|ITT|||participants|||Number
1288933|NCT00138203|Secondary|Overall Survial|Overall survial of subjects from the start of treatment to the time of death|From treatment start to time of death|All subjects who were considered evaulable (received more than one treatment cycle) were included in this evaluation|||months||Full Range|Median
1288733|NCT00141102|Secondary|Number of Subjects With CSULGIEs by History of GD Ulceration|CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.|6 month treatment duration|ITT. n = number of subjects who had history or no history of GD ulceration.|||participants|||Number
1288734|NCT00141102|Secondary|Number of Subjects With SUs|Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.|6 month treatment duration|ITT.|||participants|||Number
1288735|NCT00141102|Secondary|Change From Baseline in Patient’s Global Arthritis Assessment at Month 6/Early Termination (ET)|Subjects rated response to question: “Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?” using a 1 to 5 grading scale where 1=very good and 5=very poor.|Month 6/Early Termination (ET)|ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used.|||scores on a scale||Standard Error|Least Squares Mean
1288736|NCT00141102|Secondary|Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)|CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.|6 month treatment duration|ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee.|||participants|||Number
1288737|NCT00141102|Primary|Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)|CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.|6 month treatment duration|Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.|||participants|||Number
1288738|NCT00141037|Primary|Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation|"Biopsy-proven acute renal (kidney) rejection [1, 2].~Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]~Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Up to one year post kidney transplantation procedure|All Enrolled Subjects|||Rejection Events||95% Confidence Interval|Number
1288739|NCT00141037|Primary|The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation|Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free|One year post kidney transplantation procedure|All Enrolled Subjects|||Standard Deviation Score (SDS)||Standard Deviation|Mean
1288740|NCT00140842|Secondary|Visceral Adipose Tissue|Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)|Baseline|The analysis was completed on the 30 participants as per protocol|||grams||Standard Deviation|Mean
1288741|NCT00140842|Primary|Peak Growth Hormone (GH) on the GH Stimulation Test|Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.|Baseline|This was a cross-sectional study to compare differences in growth hormone (GH) secretory status in relation to body composition in obese versus normal-weight girls. This was a pilot study and the analysis was performed using a Student t-test to compare means across groups|||ng/ml||Standard Deviation|Mean
1288742|NCT00140621|Primary|Change From Baseline in LVM at Week 156|Left ventricular mass was assessed by echocardiogram.|Baseline to Week 156|EEP.|||gm||95% Confidence Interval|Least Squares Mean
1288743|NCT00140621|Primary|Percent Change From Baseline in Left Ventricular Mass (LVM) at Week 156|Left ventricular mass was assessed by echocardiogram.|Baseline to Week 156|EEP.|||percent change||95% Confidence Interval|Least Squares Mean
1288744|NCT00140621|Secondary|Change From Baseline in Short Form (36) Health Survey (SF-36) Scores at Week 156|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline to Week 156|EEP.|||units on a scale||Standard Deviation|Mean
1288745|NCT00140621|Secondary|Percent Change From Baseline in GL-3 Plasma Levels at Week 156||Baseline to Week 156|EEP.|||percent change||95% Confidence Interval|Least Squares Mean
1288760|NCT00140426|Secondary|Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC)|"The Multidimensional Anxiety Scale for Children (MASC) is a self report measure completed by the subject that measures anxiety symptoms.~Higher scores indicate greater anxiety. A score of over 50 is significant for anxiety~Change in MASC scores was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly to study end point||||units on a scale||Standard Deviation|Mean
1288746|NCT00140621|Secondary|Number of Participants in Overall Cardiac Function Assessment and Clinical Symptoms at Week 156: Change From Baseline in Cardiac Function Test|Overall cardiac function assessment was assessed by tests (echocardiogram,cardiac catheterization (optional),electrocardiogram,B-type natriuretic peptide [BNP]), clinical symptoms (subjective symptoms) and the New York Heart Association (NYHA) cardiac functional classification.Overall assessment of cardiac function was assessed based on the evaluation items including interventricular septum thickness, left ventricular posterior wall thickness, left ventricular mass, clinical function tests and clinical symptoms. A subject was considered to be Improved: if Improved in 2 items or more, Unchanged: Improved in one item and unchanged in 2 items or unchanged in all 3 items, Aggravated: Aggravated in one item or more.|Baseline to Week 156|EEP.|||participants|||Number
1288747|NCT00140621|Primary|Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156|Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.|Baseline to Week 156|EEP.|||mm||95% Confidence Interval|Least Squares Mean
1288748|NCT00140621|Primary|Percent Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156|Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.|Baseline to Week 156|EEP.|||percent change||95% Confidence Interval|Least Squares Mean
1288749|NCT00140556|Secondary|Failure Free Survival||3 yrs|||||||
1288750|NCT00140556|Secondary|Local Regional Control||1 yr following chemoradiation|||||||
1288751|NCT00140556|Primary|Tumor Resolution|Complete response (resolution) of tumor on clinical exam.|Within 30 days of completing RT|2 participants had occult primaries, thus were not included in clinical complete response|||Participants|||Number
1288752|NCT00140426|Primary|Body Image Software (BIS) - Difference Limen (DL)|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS-DL was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. Interpreting the DL occurs by referencing it to DL= 0, which would reflect a total inability to detect size differences, which has never occurred in studies using the BIS program."|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.|||units on a scale||Standard Deviation|Mean
1288753|NCT00140426|Primary|Body Image Software (BIS) - Point of Subjective Equality (PSE)|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS -PSE was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. Interpreting the PSE is how it compares to a PSE = 0, which is no distortion in body size."|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.|||units on a scale||Standard Deviation|Mean
1288754|NCT00140426|Primary|Body Image Software (BIS): Average Desired Thinness|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image. The BIS program calculates the difference between their actual image, and how much they have adjusted the image to represent their desired image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS - Average Desired Thinness score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. . There are no subscales."|monthly|Many patients did not complete this outcome measurement. Change from baseline to end of study were compared between arms.|||units on a scale||Standard Deviation|Mean
1288755|NCT00140426|Primary|Body Image Software (BIS): Average Distortion|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer using the direction to adjust their image to how they see themselves right now, this determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in the BIS Average Distortion score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. The BIS program calculates the difference between their actual image and the size of the image they have adjusted the digital image to based on their perception of how they see themselves right now"|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.|||units on a scale||Standard Deviation|Mean
1288756|NCT00140426|Primary|Color A Person Test (CAPT)|"Color A Person Test (CAPT) - Subjects color an outlined image of a body to indicate body dissatisfaction (red (5)= very dissatisfied, Yellow, dissatisfied, black, neutral, green satisfied, blue very satisfied (1). The outline is divided into16 sections for scoring. The CAPT was completed at baseline and monthly during study participation.~Total CAPT scores were calculated by adding the total score and dividing by 16. Score range is 1-5. Lower scores indicate less body dissatisfaction.~Change in the CAPT score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly||||units on a scale||Standard Deviation|Mean
1288757|NCT00140426|Secondary|Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study|The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities.|0 - 18 weeks||||weeks||Standard Error|Mean
1288758|NCT00140426|Secondary|Change in Prolactin Levels|Prolactin serum blood levels, measured in nanograms / ml|week 0 and week 7||||ng/ml||Standard Deviation|Mean
1288759|NCT00140426|Secondary|Change in Leptin Levels|Leptin levels were measured by serum blood draws, results reports in nanograms / ml (ng/ml).|Week 0 and week 7||||ng/ml||Standard Deviation|Mean
1295362|NCT00082810|Secondary|Time to Progression (TTP)|TTP was estimated using the Kaplan–Meier method.|From randomization until progression of the disease, assessed up to 4 years||||months||95% Confidence Interval|Median
1288761|NCT00140426|Secondary|Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study|The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. This was measured weekly from 0-18 weeks.|weekly||||weeks||Standard Error|Mean
1288762|NCT00140426|Primary|Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior)|"The Ease of Eating Scale (EOES) is a 14 item scale which measures Food avoidance behaviors (FABs). The scale is rated by staff observing a subject eating a meal or snack. 0 = normal eating behavior, maximum score 28.~Higher scores indicate more food avoidance behaviors, such as taking small bites, taking > 30 seconds between bites (slow eating), etc.~EOE was completed for each meal a subject ate in the program and scores were averaged for each week in the study and entered in the data base.~Change in EOES score was calculated by evaluating change over time. This measure was only used in Phase 1 of the study, for days the subjects were in the treatment program."|weekly up to study endpoint: reaching target weight and maintaining for 1 month|2 patients in the placebo group were treated as inpatients and had no EOE data.|||hazard ratio||95% Confidence Interval|Number
1288763|NCT00140426|Primary|Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD)|"change in Eating Disorder Inventory (EDI) 2-score for Body Dissatisfaction (BD).~Lower scores are better on this scale. Higher scores indicate the subject has greater body dissatisfaction. BD is one of the 8 subscales of the EDI-2. 9 of the 91 questions in the EDI-2 scale constitute this subscale. The score range is 0-27. Subjects completed the EDI-2 at baseline and monthly during study participation (range 0 to 18 weeks). Change in the BD subscale score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly|1 risperidone subject was missing data for BD at this data point.|||units on a scale||Standard Deviation|Mean
1288764|NCT00140426|Primary|Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT)|"Eating Disorder Inventory -2 - Subscale : Drive for Thinness Subscale (DT). Lower scores are better on this scale and indicate less cognitive focus on drive for thinness.~The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). The DT subscale was used for this outcome. Respondents rate each item as usually , often, sometimes, rarely or never. Subscale scores are computed by summing all item scores for each subscale. There are 7 items in the DT subscale (questions 1,7,11,16,25,32 and 49). the subscale score range is 0-21. The EDI-2 was completed by subjects at baseline and then monthly during study participation (range 0 -18 weeks). Change in the DT subscale score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|month||||units on a scale||Standard Deviation|Mean
1288765|NCT00140413|Primary|Change in Anthropometric Measures Over Time|Primary outcome measures included change in stature, weight, BMI, and weight-for-stature z-scores over the course of the study. Z-score indicates how many standard deviations an element is from the mean. It is calculated as z = (x – µ) σ, where µ is the mean of the population, and σ is the standard deviation of the population. A positive z-score indicates a datum above the mean, while a negative z-score indicates a datum below the mean. All z-scores were obtained using Epi Info ™ 3.5.4. (Centers for Disease Control, Atlanta, GA).|Baseline and 36 months||||Z-score||Inter-Quartile Range|Median
1288766|NCT00140244|Secondary|Hepatic Fat Content||At the end of each two month intervention||||percentage of liver volume||Standard Error|Mean
1288767|NCT00140244|Secondary|Interleukin-6 (IL-6) Levels||At the end of each two month intervention||||pg/ml||Standard Error|Mean
1288768|NCT00140244|Secondary|CD4+ Lymphocytes||At the end of each two month intervention||||cells/mcl||Standard Error|Mean
1288769|NCT00140244|Secondary|Viral Load||At the end of each two month intervention||||copies/ml||Standard Error|Mean
1288770|NCT00140244|Secondary|Lean Body Mass|lean body mass|At the end of each two month intervention||||kg||Standard Error|Mean
1288771|NCT00140244|Secondary|Insulin Levels||At the end of each two month intervention||||mcIU/ml||Standard Error|Mean
1288772|NCT00140244|Secondary|Fibrinogen|Fibrinogen|At the end of each two month intervention||||mg/dL||Standard Error|Mean
1288773|NCT00140244|Secondary|Blood Pressure|percent change in mean blood pressure|At the end of each two month intervention||||percentage change of mean blood pressure||Standard Error|Least Squares Mean
1288774|NCT00140244|Secondary|Free Fatty Acid (FFA) Levels||At the end of each two month intervention||||mEq/liter||Standard Error|Mean
1288775|NCT00140244|Secondary|Low Density Lipoprotein (LDL) Cholesterol Levels||At the end of each two month intervention||||mg/dl||Standard Error|Mean
1288776|NCT00140244|Secondary|Glycemia (as Assessed by Fasting Glucose)||At the end of each two month intervention||||mg/dl||Standard Error|Mean
1288777|NCT00140244|Secondary|Insulin Resistance (as Assessed by HOMA-IR)||At the end of each two month intervention||||units on a scale||Standard Error|Mean
1288778|NCT00140244|Primary|Serum Lipid Levels||At the end of each two month intervention||||mg/dl||Standard Error|Mean
1288779|NCT00140231|Secondary|Autonomic Function|aldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1|four days||||pg/ml||Standard Error|Mean
1288780|NCT00140231|Secondary|(RMR)|Resting Metabolic rate using calorimetry|four days||||kcal/d||Standard Deviation|Mean
1288781|NCT00140231|Secondary|%Fat Mass||four days||||fat%||Standard Deviation|Mean
1288782|NCT00140231|Primary|Immune Function CD3 Count||4 days||||cells/ul||Standard Error|Mean
1288783|NCT00140231|Primary|ACTH Mean Level|Response of ACTH to leptin administration in fed and fasting state from baseline was measured|4 days||||pg/ml||Standard Error|Mean
1288784|NCT00140231|Primary|Cortisol||four days||||ug/dl||Standard Deviation|Mean
1288785|NCT00140205|Secondary|Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)|Data were collected neither in Fed nor in Fasting state for the different doses of leptin|day 3 of fasting and day 1 of fed state|||||||
1288786|NCT00140205|Secondary|Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)|Data were collected neither in Fed nor in Fasting state for the different doses of leptin|1 DAY or DAY 3|||||||
1288807|NCT00140140|Secondary|Kaplan Meier Estimate for Progression-Free Survival (PFS)|"PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Because no patients died as a result of a non-disease progression event, the analysis of PFS was identical to the analysis for TTP."|up to month 30|Treated population of participants who had disease progression or who died|||months||95% Confidence Interval|Median
1288808|NCT00140140|Secondary|Kaplan-Meier Estimate for Duration of Response|"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Complete response (CR) and partial response (PR) are defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to month 30|Treated participants who had a response|||months||95% Confidence Interval|Median
1288809|NCT00140140|Secondary|Kaplan Meier Estimate for Time to Disease Progression (TTP)|"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to month 30|Treated population of participants with disease progression|||months||95% Confidence Interval|Median
1288810|NCT00140140|Secondary|Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #1 for definitions of CR and PR.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|up to month 30|Treated population|||percentage of participants|||Number
1288811|NCT00140140|Primary|Nadir Measurement for Hemoglobin (Hgb)|Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment.|up to week 129 (longest treatment)|Treated population|||g/L||Standard Deviation|Mean
1288812|NCT00140140|Primary|Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count|Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment.|up to week 129 (longest treatment)|Treated population|||10^9/L||Standard Deviation|Mean
1288813|NCT00140140|Primary|Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) blood counts were graded using NCI CTCAE version 3.~ANC:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal – 1.5*10^9/L; Grade 2 = <1.5 - 1.0*10^9/L; Grade 3 = <1.0 - 0.5*10^9/L; Grade 4 = <0.5*10^9/L~WBC:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 – 1.0*10^9/L; Grade 4 = <1.0*10^9/L~Platelets:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 – 25.0*10^9/L; Grade 4 = <25.0*10^9/L~Hemoglobin:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal – 100 g/L ; Grade 2 = <100 – 80 g/L; Grade 3 = <80 – 65 g/L; Grade 4 = <65 g/L"|up to week 129 (longest treatment)|Treated population|||participants|||Number
1288814|NCT00140140|Primary|Percentage of Participants With Discontinued, Delayed or Interrupted Therapy|Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.|up to week 129|Treated population|||percentage of participants|||Number
1288815|NCT00140140|Primary|Participants With Dose Limiting Toxicities|"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Any drug-related toxicities CTC Grade 3 or higher were considered dose limiting. Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death. Other conditions considered dose-limiting toxicities include:~requirement of a dose adjustment during the first 4 weeks~a dose delay of >3 weeks during the first 4 weeks Grade 3 or greater toxicities attributed to the use of Herceptin were not considered dose-limiting toxicities.~The optimal tolerated dose of ABI-007 and vinorelbine given concurrently was defined as the dose administered in the absence of DLTs."|up to month 1|Treated population|||participants|||Number
1288816|NCT00140140|Primary|Participants With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|"Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation.~Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits."|up to month 30|Treated population|||percentage of participants||95% Confidence Interval|Number
1288817|NCT00139997|Secondary|SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version|SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.|Weekly following randomization|These participants are analyzed ITT- last observation carried forward.|||units on a scale||Standard Deviation|Mean
1288818|NCT00139997|Primary|Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version|"SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.~Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization"|Week 4|These participants are analyzed ITT- last observation carried forward.|||Percentage of SIGH SAD||Standard Deviation|Mean
1288819|NCT00139776|Other Pre-specified|Serious Adverse Events in Open Label run-in Period|Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily|2 weeks prior to double blind dosing|1197 participants entered the open-label run-in (period II) to allow observation of successful treatment of an osteoarthritis flare. 875 participants were randomized to double blind treatment (period III). 322 participants were not randomized.|||participants|||Number
1288820|NCT00139776|Other Pre-specified|Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments|SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)"|||scores on a scale||Standard Deviation|Mean
1288821|NCT00139776|Other Pre-specified|Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep|Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III|Period III|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication|||participants|||Number
1288822|NCT00139776|Secondary|Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores|WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424"|||scores on a scale * weeks||Standard Deviation|Mean
1288823|NCT00139776|Other Pre-specified|Change in Medical Outcomes Study Sleep Scale - All Assessments|Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.|Period III|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)|||scores on a scale||Standard Deviation|Mean
1288824|NCT00139776|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores|Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424|||scores on a scale||Standard Error|Least Squares Mean
1288825|NCT00139776|Secondary|Days on Flare Medication|Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects who did not take flare medication were calculated as 0 and included in the analysis.~Number of subjects taking flare medication: continuous use n=282; intermittent use n=339."|||days on medication per month per subject||Standard Deviation|Mean
1288826|NCT00139776|Secondary|Proportion of Days on Rescue Medication|Days on rescue medication divided by number of days on study medication in Period III|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.~Subjects who did not take rescue medication were calculated as 0 and included in the analysis."|||proportion of days||Standard Deviation|Mean
1288827|NCT00139776|Secondary|Total Rescue Medication Taken (Mean)|Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects who did not take rescue medication were assumed to have taken 0mg and were included in the analysis.~Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239."|||mg taken per month per participant||Standard Deviation|Mean
1288829|NCT00139776|Secondary|Patient's Global Assessment of Arthritis|"Participant's response to question Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today? on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III."|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II."|||scores on a scale * weeks||Standard Error|Least Squares Mean
1288830|NCT00139776|Secondary|Arthritis Pain Numerical Rating Scale (NRS)|Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II."|||scores on a scale * weeks||Standard Error|Least Squares Mean
1288831|NCT00139776|Secondary|Proportion of Days in Osteoarthritis (OA) Flare|Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)||||proportion of days in OA flare||Standard Deviation|Mean
1288832|NCT00139776|Secondary|Proportion of Days Free From Osteoarthritis (OA) Flare|Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication|||proportion of days free from OA flare||Standard Deviation|Mean
1288833|NCT00139776|Secondary|Time to Occurrence of First Osteoarthritis (OA) Flare|Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.|||days||95% Confidence Interval|Median
1288834|NCT00139776|Primary|Number of Flare Events Per Time of Exposure to Study Medication|Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication|||flare events per month||Standard Deviation|Mean
1288835|NCT00139737|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.|Baseline up to 72 months|Safety Analysis Set = All subjects who took at least 1 dose of study drug|||Participants|||Number
1288836|NCT00139659|Primary|Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)|Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||mL/min/mmHg||Standard Deviation|Mean
1288837|NCT00139659|Primary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.|Baseline through Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS): all subjects who were randomized, had a baseline post-albuterol pulmonary function test (PFT) measurement, and had at least two post-baseline, post-albuterol PFT measurements. LOCF: last observation carried forward.|||liters||Standard Deviation|Mean
1288838|NCT00139659|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); blood glucose measurement was ≤ 49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Crude event rate = number of events divided by 100 subject-months. Subject months = elapsed number of months subject was in study in each time interval.|0 to 1 month to 11 to 12 months, and Overall|Full analysis set (FAS). Due the small number of events severe hypoglycemic event rates were assessed per 100 months.|||Number of events/100 subject-months.|||Number
1288839|NCT00139659|Secondary|Hypoglycemic Event Rates|A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate = total events divided by subject months. Subject months = elapsed number of months a subject was in the study in each time interval.|0 to 1 month to 11 to 12 months, and Overall|Full analysis set (FAS)|||events / subject-months|||Number
1288840|NCT00139659|Secondary|Lipids: Median Change From Baseline to Last Observation|Lipids: median changes (milligrams per deciliter [mg/dL]) from Baseline median to last observation in cholesterol (random), triglycerides (random), high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. Normalized data was used in the computations. Last observation = last observation while on study drug or during the lag. Measures of dispersion for median changes in lipids were not determined.|Baseline to Last Observation|Primary analysis set (PAS); median change from Baseline to last observation. Last observation was defined as last observation while on study drug or during the lag. Full range (-999 to 999) was not calculated.|||mg/dL|||Number
1288841|NCT00139659|Secondary|Total Daily Short-Acting Insulin Dose Adjusted for Body Weight|Total Daily Short-Acting Insulin Dose adjusted for body weight (units divided by kg). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)|||mg/kg, units/kg||Standard Deviation|Mean
1288842|NCT00139659|Secondary|Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Average Total Daily Insulin Dose: short-acting insulin (milligrams [mg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)|||mg, units||Standard Deviation|Mean
1288843|NCT00139659|Secondary|Total Daily Long-Acting Insulin Dose Adjusted for Body Weight|"Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.~Inhaled Insulin reported in mg/kg. Subcutaneous Insulin reported in units/kg."|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)|||mg/kg, units/kg||Standard Deviation|Mean
1288844|NCT00139659|Secondary|Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)|"Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight: long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.~Inhaled Insulin reported in mg. Subcutaneous Insulin reported in units."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)|||mg, units||Standard Deviation|Mean
1288845|NCT00139659|Secondary|Body Weight: Mean Baseline and Change From Baseline|Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus baseline value.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Primary analysis set (PAS)|||kilograms||Standard Deviation|Mean
1288846|NCT00139659|Secondary|Fasting Plasma Glucose|Fasting plasma glucose (milligrams per deciliter [mg/dL]) at Baseline, and change from Baseline. Change from baseline: mean of value of fasting plasma glucose in mg/dL at observation minus baseline value.|Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Primary analysis set (PAS); Last Observation Carried Forward: if the end of study value was missing the last available observation for that subject was used..|||mg/dL||Standard Deviation|Mean
1288847|NCT00139659|Secondary|Glycosylated Hemoglobin (HbA1c)|Glycosylated Hemoglobin (HbA1c): observed mean values at Baseline and each observation, and change from Baseline. Change from Baseline = mean HbA1c at observation minus mean HbA1c at Baseline.|Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS)|||percent||Standard Deviation|Mean
1288848|NCT00139659|Secondary|Transition Dyspnea Index (TDI): Change in Total Score|Transition Dyspnea Index total score = sum of the numeric grades from the three dyspnea index questions: Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort. Rating scale: -3 (major deterioration), -2 (moderate deterioration), -1 (minor deterioration, 0 (no change), +1 (minor improvement), +2 (moderate improvement), +3 (major improvement).|Week 4, Week 12, Week 26, Week 39, Week 52|Full analysis set (FAS)|||scores on scale||Standard Deviation|Mean
1288849|NCT00139659|Secondary|Baseline Dyspnea Index (BDI)|Total score = the sum of the numeric grades from the three dyspnea index questions. Functional Impairment rating scale: Grade 4 (no impairment) to Grade 0 (very severe impairment); Magnitude of Task rating scale: Grade 4 (extraordinary) to Grade 0 (no task); and Magnitude of Effort rating scale: Grade 4 (extraordinary) to grade 0 (no effort).|run-in period|Full analysis set (FAS)|||scores on scale||Standard Deviation|Mean
1288850|NCT00139659|Secondary|Asthma Control as Measured by the Asthma Control Questionnaire©|Asthma Control Questionnaire©: 6 self-administered questions that assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; 7-point ordinal rating scale from 0 (good control) to 6 (poor control). A seventh question was completed by a health professional on forced expiratory volume in 1 second (FEV1) % predicted using a one-week recall period; scale: 0 (>95% predicted) to 6 (<50% predicted). Overall score = mean of questions 1 - 7.|Baseline, Weeks 4, 12, 26, 39, 52|FAS; abbreviations: Eval = evaluations, BL = Baseline.|||scores on scale||Standard Deviation|Mean
1288851|NCT00139659|Primary|Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)|Annualized rates of change (slope throughout time from baseline to end of study[visit]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.|Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52|Primary analysis set (PAS).|||ml/min/mmHg/yr||Standard Error|Mean
1288852|NCT00139659|Secondary|Number of Systemic Corticosteroid Rescues|Number of subjects who used a systemic corticosteroid at any time during the study, and the total number of systemic corticosteroid rescues. New rescue event = >=2 consecutive days between the end of one event and the start of another event.|Baseline through Week 52|Full analysis set (FAS); number of subjects with systemic corticosteroid rescues = inhaled insulin: 12, and subcutaneous insulin: 14. Due to inconsistencies in data entry, the numbers of systemic corticosteroid rescues were not considered entirely accurate.|||systemic corticosteriod rescues|||Number
1288853|NCT00139659|Secondary|Incidence of Severe Asthma Exacerbations|Severe asthma exacerbation was defined as one of the following: subject received oral (systemic) corticosteriods for the treatment of asthma; or subject had an unscheduled visit to a physician, emergency room, or hospital for the treatment of asthma. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months * 100.|0 to 1 Week to > 12 Months|Full analysis set (FAS); due to inconsistencies in data entry for systemic steroids, the protocol definition for severe asthma exacerbations, which was based on systemic corticosteroid use for asthma, could not be accurately assessed. Due the small number of events the incidence of severe asthma exacerbations was assessed per 100 months.|||events/subject months*100|||Number
1288854|NCT00139659|Secondary|Incidence of Non-severe Asthma Exacerbations|Non-severe asthma exacerbation = one of the following: any home monitored morning (4:45 am - 10:15 am) forced expiratory volume in 1 second (FEV1) <80% of the morning baseline for 2 or more consecutive days; or home monitored FEV1 <60% of Baseline at any time. Percent of Baseline = 100*(daily FEV1)/Baseline weekly FEV1. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months.|0 to 1 week to > 12 months|FAS; review of source data for this endpoint showed excessive data variability for home-monitored FEV1 with outliers ranging from 0.01 to >100, and many subjects with random peaks and dips of 100% or more of their baseline. It is unlikely that the protocol definition is robust enough to provide real information about exacerbation frequencies.|||events/subject-months|||Number
1288855|NCT00139659|Secondary|Mean Weekly Asthma Symptom Scores|Mean weekly asthma symptom scores: subjects recorded their asthma symptom scores in an electronic symptom diary twice daily throughout the study, immediately upon awakening (5-10 AM) and in the evening or at bedtime (7-12 PM). Questions included extent of albuterol use, symptoms of wheezing, coughing, activity limitations and sleep; scale 0 (none/fine) to 3 (severe/ continuous/bad night).|Baseline through end of study|Data for mean weekly asthma symptom scores were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.|||scores on scale||Standard Deviation|Mean
1288856|NCT00139659|Secondary|Step Classification of Asthma Severity by Medication Usage|Step classification of asthma severity by medication usage. Subjects were classified at each visit according to the medication used on the day of the particular time-point; Step 1: intermittent asthma, Step 2: mild persistent asthma, Step 3: moderate persistent asthma, Step 4: severe persistent asthma. The number (%) of subjects in each step classification were provided at each assessment timepoint with a shift table indicating the number (%) of subjects moving from each step classification at each time-point.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58|Data for step classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.|||subjects|||Number
1288857|NCT00139659|Secondary|Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage|All asthma medication changes during the study were classified as step-up or step-down according to treatment guidelines. Step 1: Intermittant Asthma; Step 2: Mild Persistent Asthma; Step 3: Moderate Persistent Asthma; Step 4: Severe Persistent Asthma. The number of subjects in each step classification of asthma severity were provided at each assessment timepoint for each treatment group, with a shift table indicating the number of subjects moving from each step classification at each timepoint.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58|Data for the number of step-up and step-down changes in classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.|||subjects|||Number
1288858|NCT00139659|Secondary|Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)|All subjects used an electronic symptom diary to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol) daily, immediately upon arising, and again in the evening or before bed.|Daily: Baseline to end of study|Mean weekly number of puffs of albuterol was not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.|||number of puffs||Standard Deviation|Mean
1288859|NCT00139659|Secondary|Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)|Subjects measured peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) twice daily and entered the results in an electronic diary. Daily data were used to calculate the mean PEFR and FEV1 for each week (observed weekly mean and change from baseline in weekly mean). For each subject, the mean weekly morning (and evening) PEFR and FEV1 was defined as the sum of the daily morning (and evening) PEFR (and FEV1) measurements during the week divided by the number of non-missing PEFR (and FEV1) measurements during the week.|Week -3 through Week 52|Mean weekly morning and evening peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.|||liters||Standard Deviation|Mean
1288860|NCT00139659|Secondary|Methacholine Challenge|Methacholine Challange: performed on a subset of subjects using the 5-breath dosimeter method. Subjects were challenged with ascending doses of nebulized methacholine; dosing schedule: 0.03, 0.06, 0.12, 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 milligrams per milliliter (mg/ml) administered in 5-minute intervals. Forced expiratory volume in 1 second (FEV1) was measured 1-3 minutes after each inhalation of methacholine solution. Testing continued until highest FEV1 decreased by ≥20% from the challenge (post-diluent) reference, or until completion all doses.|1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5)|There were no methacholine challenges performed in subjects using inhaled insulin due to protocol-defined exclusion criteria for methacholine challenge testing, and methacholine provocative concentration [of methacholine] causing a 20% fall in FEV1 (PC20) data were not analyzed.|||liters||Standard Deviation|Mean
1288861|NCT00139659|Secondary|Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin|Carbon Monoxide Diffusing Capacity (DLco) dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin was defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value.|Baseline, Week 9, Week 51|Full analysis set (FAS)|||ml/min/mmHg||Standard Deviation|Mean
1288862|NCT00139659|Secondary|Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)|Percent predicted change from Baseline in 10 Minute and 60 Minute post-insulin forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in FEV1 measured in liters (L) 10 and 60 Minutes post-insulin. Percent change = (value at observation minus Baseline value) divided by Baseline value *100%.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||percent||Standard Deviation|Mean
1288863|NCT00139659|Secondary|Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin|Change from Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in one second (FEV1) measured 10 and 60 minutes after the first daily dose of insulin. Insulin dose responsiveness = the difference between FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post dose FEV1 value minus predose FEV1 value.|Baseline, Week 9, Week 51|Full analysis set (FAS)|||liters||Standard Deviation|Mean
1288864|NCT00139659|Secondary|Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)|Percent predicted change from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in post-bronchdilator FEV1 measured in liters (L): (observed value minus Baseline value) divided by Baseline value *100%.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||percentage of FEV1||Standard Deviation|Mean
1288865|NCT00139659|Secondary|Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol|Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52|Full analysis set (FAS)|||percent change in FEV1||Standard Deviation|Mean
1288866|NCT00139659|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||liters||Standard Deviation|Mean
1288867|NCT00139659|Secondary|Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)|Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||ml/min/mmHg||Standard Deviation|Mean
1288868|NCT00139659|Secondary|Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)|Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward|Full analysis set (FAS); LOCF: last observation carried forward.|||liters||Standard Deviation|Mean
1288869|NCT00139659|Secondary|Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)|Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||ml/min/mmHg||Standard Deviation|Mean
1288870|NCT00139659|Secondary|Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||liters||Standard Error|Mean
1288871|NCT00139659|Primary|Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)|Annualized rates of change (slope throughout time from baseline to end of study[visit]) for forced expiratory volume in 1 second (FEV1) (liters per year [L/yr]) measured 30 minutes following the administration of albuterol.|Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52|Primary analysis set (PAS): all subjects who were randomized, had no significant protocol violations, had baseline (BL) post-albuterol pulmonary function test (PFT) measurement, had at least 2 post-BL, post-albuterol PFT measurements with 1 measurement at least 6 months post-BL, and received study drug for at least 50% (154 days) of study duration.|||L/yr||Standard Error|Mean
1288872|NCT00139477|Primary|Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months|Value at 6 months minus value at baseline. PAI-1 is the primary physiological inhibitor of fibrinolysis and proteolysis. High PAI-1 levels have been linked to thrombosis and fibrosis, insulin resistance and obesity. PAI-1 was measured by ELISA (American Diagnostica, Stamford, CT, USA).|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group and 1 Subject in the Diet/Exercise, then Diet/Exercise plus Metformin (Pubertal) Group did not have a PAI-1 level available for analysis."|||ng/ML||Inter-Quartile Range|Median
1288873|NCT00139477|Primary|Change From Baseline in Interleukin 6 (IL-6) at 6 Months|Value at 6 months minus value at baseline. IL-6 is a pro-inflammatory cytokine thought to produce a state of low-grade inflammation in obese individuals. IL-6 stimulates hepatic production of C-reactive protein (CRP), an acute phase protein which is a sensitive marker for systemic inflammation. IL-6 was measured by enzyme-linked immunosorbent assay (ELISA; R&D Systems, Minneapolis, MN, USA).|Baseline and 6 months||||pg/mL||Inter-Quartile Range|Median
1288874|NCT00139477|Primary|Change From Baseline in Fibrinogen at 6 Months|Value at 6 months minus value at baseline. Fibrinogen is a hepatic-derived factor directly involved in clotting and in the viscosity characteristics of blood flow. It binds to platelets and contributes to their aggregation, promotes fibrin formation and is also an acute phase reactant that is increased in inflammatory states. Fibrinogen concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA).|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group did not have a Fibrinogen level available for analysis."|||mg/dL||Inter-Quartile Range|Median
1288875|NCT00139477|Primary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months|Value at 6 months minus value at baseline. HsCRP is an acute phase protein which is a sensitive marker for systemic inflammation. HsCRP concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA), with an hsCRP lower sensitivity of 0.156 mg/L.|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group did not have an hsCRP level available for analysis."|||mg/dL||Inter-Quartile Range|Median
1288876|NCT00139477|Primary|Protocol #1: Serum Marker Levels Between Obese and Lean Children|This outcome measure is from Protocol #1 (a cross-sectional study); results are not posted.|Screening Visit|||||||
1288877|NCT00138671|Secondary|Severe Hypoglcyemic Event Rates|An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 month to > 11 months|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||events / 100 subject-months|||Number
1288878|NCT00138671|Secondary|Hypoglycemic Event Rates|A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to1 month to > 11 months|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||events / subject-month|||Number
1288879|NCT00138671|Secondary|Lipids|Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.|Duration of the study||||mg/dL|||Number
1288880|NCT00138671|Secondary|Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)|Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. Dose was adjusted for body weight (mg divided by kg or units divided by kg).|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mg/kg, Units/kg||Standard Deviation|Mean
1288881|NCT00138671|Secondary|Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)|Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||Units/kg||Standard Deviation|Mean
1288882|NCT00138671|Secondary|Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mg, Units||Standard Deviation|Mean
1288883|NCT00138671|Secondary|Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)|Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||Units||Standard Deviation|Mean
1288884|NCT00138671|Secondary|Change From Baseline in Body Weight|Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52|FAS, HbA1c=randomized subjects with >=1 study drug dose, baseline and >=1 post-baseline HbA1c measurement. Last Observation Carried Forward (LOCF) method used. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin. Week 11 and 50 visits were part of the methacholine substudy and were not required visits for all subjects.|||kg||Standard Deviation|Mean
1288885|NCT00138671|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).|Baseline, Weeks 6, 12, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mg/dL||Standard Deviation|Mean
1288886|NCT00138671|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).|Baseline, Weeks 6, 12, 26, 39, and 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||percent||Standard Deviation|Mean
1288887|NCT00138671|Secondary|Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires|The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.|Duration of the study||||grade|||Number
1290436|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|30 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1288888|NCT00138671|Secondary|Incidence of Severe COPD Exacerbations|Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 week to > 9 months|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||events/subject-month (crude event rate)|||Number
1288889|NCT00138671|Secondary|Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 week to > 9 months|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||events/subject-month (crude event rate)|||Number
1288890|NCT00138671|Secondary|Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used|All subjects used diary cards to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol plus ipratropium plus Combivent®, as applicable) daily, immediately upon arising, and again in the evening or before bed. Mean weekly number of puffs of short-acting bronchodilator used data were collected, but not analyzed.|Duration of the study||||puffs|||Number
1288891|NCT00138671|Secondary|Methacholine PC20|Methacholine challenge testing was conducted at selected sites at visits which did not occur at other sites (Weeks -2.9, -0.9, 11, 50 and 52+5). Methacholine challenge was not analyzed as there was only 1 test performed, which was a baseline test, and no methacholine tests performed in subjects using inhaled insulin.|Duration of the study||||mg/mL|||Number
1288892|NCT00138671|Secondary|Insulin Dose Responsiveness for DLco|DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value).|Baseline, Week 9, Week 51|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had a FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mL/min/mmHg||Standard Deviation|Mean
1288893|NCT00138671|Secondary|Insulin Dose Responsiveness for FEV1|FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value).|Baseline, Week 9, Week 51|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||L||Standard Deviation|Mean
1288894|NCT00138671|Secondary|Bronchodilator Responsiveness as Determined by the Change in FEV1|Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.|Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||percent change||Standard Deviation|Mean
1288895|NCT00138671|Secondary|Other PFTs (Besides FEV1 and DLco)|Other PFTs (besides FEV1 and DLco) were measured 30 minutes following the administration of ipratropium. Other PFTs included forced vital capacity (FVC), peak expiratory flow rate (maximal forced expiratory flow) (PEFR[FEFmax]), and forced expiratory flow from 25% to 75% of vital capacity (FEF25%-75%). Other PFT data were collected, but not analyzed.|Duration of the study||||mL|||Number
1288896|NCT00138671|Primary|Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)|DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mL/min/mmHg||Standard Deviation|Mean
1288897|NCT00138671|Secondary|Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)|Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.|Duration of the study||||mL/min/mmHg|||Number
1288898|NCT00138671|Secondary|Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)|Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.|Duration of the study||||L|||Number
1288899|NCT00138671|Primary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|Full Analysis Set (FAS), FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||L||Standard Deviation|Mean
1289012|NCT00137046|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) measured in liters (L).|Week -3 through Extension Follow-up Month 6 or End of Study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and FVC results were not summarized as planned.|||liters||Standard Deviation|Mean
1288900|NCT00138658|Secondary|AUC-0-last|AUC-0-last is the area under the plasma concentration time curve from time 0 to the last last time point (23.5 hrs)|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011|||ng*h/mL||Standard Deviation|Mean
1288901|NCT00138658|Secondary|t1/2 of OGX-011|Plasma half life of OGX-011|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011|||hours||Standard Deviation|Mean
1288902|NCT00138658|Primary|Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen|"Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR).~The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles.~CR: disappearance of clinical/radiological evidence of tumor.~PR: >= 30% decrease in the sum of the longest diameter of target lesions.~SD: did not fulfill the criteria for CR or PR but not progressive disease."|Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.|The efficacy analysis included all 81 subjects that received at least one dose of OGX-011. Of the 25 subjects with CR or PR, 21 subjects had a confirmed response. The other 4 patients did not have confirmatory scans (n=3) or discontinued treatment (N=1).|||percentage of participants|||Number
1288903|NCT00138658|Secondary|Cmax of OGX-011|Cmax is a plasma pharmacokinetic parameter that is defined as the maximum observed concentration of drug substance in plasma.|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011|||ng/mL||Standard Deviation|Mean
1288904|NCT00138658|Secondary|Effect of OGX-011 on Serum Clusterin Levels|To measure the effect of OGX-011 on serum clusterin levels. The drug substance, OGX-011, is an antisense product designed to bind to clusterin mRNA, resulting in the inhibition of the production of human clusterin protein. Therefore, serum clusterin levels were expected to decrease.|Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1|55 evaluable subjects had baseline value and at least one post-baseline serum clusterin assessment.|||µg/mL||Standard Deviation|Mean
1288905|NCT00138658|Secondary|Overall Survival|Overall survival was defined as time from date of first treatment with OGX-011 to the date of death from any cause. Overall survival was censored at date of last contact for subjects who were still alive at end of study.|All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.|Number of subjects who died (n=70); n=11 subjects were censored at end of study (10 were alive and 1 was lost to follow up)|||months||95% Confidence Interval|Median
1288906|NCT00138658|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as time from first treatment with OGX-011 to documented evidence of disease progression or date of death. For subjects without disease progression based on RECIST who initiated subsequent anti-cancer therapy, date of progression was defined as date of initiating new cancer treatment. PFS was censored as of the date of first OGX-011 dose for subjects who failed to return for assessments after screening. For subjects who were still alive and without progressive disease at the time of data cut-off, PFS was censored at date of last disease assessment.|All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.|Number of patients who progressed or died (n=75); data for 6 patients were censored. (PFS was censored at the date of the first dose of OGX-011 for subjects who failed to return for any disease assessments after screening.)|||months||95% Confidence Interval|Median
1288907|NCT00138645|Primary|Percent Change in Body Weight (Completers).|Percent change in body weight from baseline to week 24(completers).|24 weeks||||change in percent:baseline body weight||Standard Error|Least Squares Mean
1288908|NCT00138645|Secondary|Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6||April 2005 to May 2006|||||||
1288909|NCT00138645|Secondary|Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6||April 2005 to May 2006|||||||
1288910|NCT00138645|Secondary|Change in Body Composition at Months 3 and 6||April 2005 to May 2006|||||||
1288911|NCT00138645|Primary|Body Weight Loss (kg and Percent) at Months 3 and 6||April 2005 to May 2006|||||||
1288912|NCT00138424|Secondary|The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline and Day 35|PK parameter change from baseline to day 35 for AUC4 and AUC12|Baseline through day 35||||hr*mg/L||Full Range|Median
1288913|NCT00138424|Secondary|The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline Through Day 35|PK parameter change from baseline to day 35 for Cmax.|Baseline through day 35||||ng/mL||Full Range|Median
1288914|NCT00138424|Primary|Number of Subjects Experiencing at Least One Laboratory Abnormality|The following lab values assessed during the 49 days of subject involvement were the following: hemoglobin, hematocrit, platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), serum creatinine, calcium, phosphorous, serum albumin, glucose, uric acid, magnesium, total protein, total bilirubin, alanine aminotransferase (ALT), asparate aminotransferase (AST) and alkaline phosphate. The outcome measure is the number of subjects experiencing at least 1 grade 1 (mild) or higher event.|Baseline through day 49||||Participants|||Number
1288915|NCT00138424|Primary|Changes Observed in the Physical Examination: Heart Rate (Per Minute)|The heart rate is the number of heart beats per minute. The outcome measure is the change from baseline heart rate to day 49 heart rate.|Baseline through day 49.|Subject's whose heart rate was measured at baseline and day 49 visit|||Change in Beats per Minute||Full Range|Median
1288916|NCT00138424|Primary|Changes Observed in the Physical Examination: Body Temperature (Fahrenheit)|The temperature is a measure of body temperature in fahrenheit (F). The measure is a change between baseline temperature and day 49 temperature.|Baseline through day 49.|Subject's last visit minus baseline visit|||Temperature (F)||Full Range|Median
1288918|NCT00138424|Secondary|Allograft Function at the Completion of the Study|"Glomerular filtration rate (GFR) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the tiny filters in the kidneys, called glomeruli, each minute. The normal health GFR is about 90 - 120 mL/min/1.73 m2. Older people will have lower normal GFR levels, because GFR decreases with age.~Abnormal Results are expected to be below 60 mL/min/1.73 m2 for 3 or more months are a sign of chronic kidney disease. A GFR result below 15 mL/min/1.73 m2 may be a sign of kidney failure."|Day 49.|subjects that had GFR at each visit last visit|||mL/min/1.73 m2||Full Range|Median
1288919|NCT00138424|Primary|Changes Observed in the Physical Examination: Blood Pressure (mm/hg)|"Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. Blood pressure usually refers to the arterial pressure of the systemic circulation. During each heartbeat, blood pressure varies between a maximum (systolic) and a minimum (diastolic) pressure. The measure is the difference between the baseline systolic and baseline diastolic value with the day 49 systolic and day 49 diastolic value."|Baseline through day 49.||||mm Hg||Full Range|Median
1288920|NCT00138424|Primary|Changes Observed in the Physical Examination : Respiratory Rate (Per Minute)|Respiratory rate is the number of breaths per minute.|Baseline through day 49.|subjects whose respiratory rate was measured at baseline visit and at day 49 visit.|||Change in Breaths per Minute||Full Range|Median
1288921|NCT00138424|Primary|Number of Related Adverse Events|"The investigator’s assessment of an AE's relationship to study drug is part of the documentation process. All adverse events had their relationship to study product assessed using the following terms: associated (related)or not associated (not related). To help assess, the following guidelines were used.~Associated – There was a known temporal relationship and/or, if re-challenge was done, the event abates with de-challenge and reappears with re-challenge and/or the event was known to occur in association study product or with a product in a similar class of study products~Not Associated -the AE was completely independent of study product administration; and/or evidence existed that the event was definitely related to another etiology."|Baseline through day 49.|Number of Related Events|||Events|||Number
1288922|NCT00138424|Primary|Number of Adverse Events by Grade of Event|"Adverse events are reported as grades:~Toxicity Grade I: a mild event (an event that requires minimal or no treatment and does not interfere with the subject's daily activities.~Toxicity Grade II: a moderate event (an event that results in a low level of inconvenience or concern with the therapeutic measures and may cause some interference with functioning.~Toxicity Grade III: a severe event (an event that interrupts a subject's usual daily activity and may require systemic drug therapy or other treatment and may be incapacitating.~Toxicity Grade IV: Life threatening (any adverse drug experience that places the patient or subject at immediate risk of death from the reaction as it occurred)"|Baseline through day 49.||||Events|||Number
1288923|NCT00138424|Secondary|Number of Days to at Least 50% Reduction of Viral Load in Plasma and Urine||Baseline through day 49.||||Days||Full Range|Median
1288924|NCT00138424|Secondary|Subjects Achieving 50% Reduction Viral Load in Plasma and Urine||Baseline through day 49.||||Participants|||Number
1288925|NCT00138424|Secondary|Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit|The percent change in viral load from baseline to day 7, day 21 and day 49 as measured in the urine and measured in the blood. A drop is identified by use of '-', an increase in viral load has no sign in front of the number.|Baseline, and each visit: day 7, 21, 35 and 49.||||Percent Change||Full Range|Median
1288926|NCT00138424|Secondary|The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR|The outcome measure is the percent of subjects that achieved non-detectable BK virus in the urine and plasma polymerase chain reaction (PCR) at day 35 after staring study drug. Undetectable is a PCR viral load of less than 200.|Day 35.|Percentage of subjects|||percentage of subjects|||Number
1288927|NCT00138424|Primary|Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject|The measure is the number of adverse events (ie: events that are change from baseline)experienced by subjects. The median or average number of events and the range of events across all subjects is reported.|Baseline through day 49||||Event||Full Range|Median
1288928|NCT00138294|Secondary|Proportion of SAEs Detected in LAIV Recipients|Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.|pre-, post- influenza vaccination|This analyses was limited to the children enrolled in the intervention cities. 29255 doses of LAIV were administered to children 4-18 years of age. 21555 doses were seasonal LAIV and 7700 doses were pandemic LAIV.|||proportion of events|||Number
1288929|NCT00138294|Primary|MAARI Rate During the Epidemic and Pandemic Period (2009-2010)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|8/25/09 to 4/3/10 (32 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.|||Number of MAARI|Person Weeks||Number
1288930|NCT00138294|Primary|MAARI Rate During the Epidemic Period (2008-2009)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|1/4/2009 to 3/21/2009 (11 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.|||Number of MAARI|Person Weeks||Number
1288931|NCT00138294|Primary|MAARI Rate During the Epidemic Period (2007-2008)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|12/16/2007 to 3/29/2008 (15 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.|||Number of MAARI|Person Weeks||Number
1288934|NCT00138203|Secondary|Time to Progression|Time to progression per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.|From start of treatment to progression (average was 3.7 months)|Subjects who were considered evaluable (received more than one treatment cycle) were included in these results.|||months||Full Range|Median
1288935|NCT00138203|Primary|Response Per RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.|Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)|Only 14 subjects were evaulated for response. 2 of the total 16 subjects enrolled were not evaluable due to progression after only 1 cycle of treatment.|||participants|||Number
1288936|NCT00138151|Secondary|The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.||8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.||||||
1288937|NCT00138151|Secondary|The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.||8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.||||||
1288938|NCT00138151|Primary|Response Rate (Complete and Partial)|All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.|8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.||||||
1288939|NCT00138125|Secondary|Clinical Benefit (CR + PR + SD > 6 Months)|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||||||
1288940|NCT00138125|Secondary|Overall Survival|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||||||
1288941|NCT00138125|Secondary|Duration of Response|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||||||
1288942|NCT00138125|Secondary|Time to Tumor Progression|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||||||
1288943|NCT00138125|Secondary|Overall Objective Response Rate|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||2018||||
1288944|NCT00138125|Primary|Progression-free Survival|Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.|5 years||||participants|||Number
1288945|NCT00138073|Secondary|Individual and Collective Frequency of Use and Usage Patterns of the Web-based Waveform Interpretation Guide|The study was terminated before the secondary outcome could be measured. Usage data was not collected over the following year.|1 year|||||||
1288946|NCT00138073|Primary|Score on a Computer-based Test on Pulmonary Artery Catheter Waveform Interpretation|The study was terminated before the primary outcome could be measured. None of the participants took the post-intervention test.|1 month|||||||
1288947|NCT00138034|Secondary|Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography|The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.|6 months||||participants|||Number
1288948|NCT00138034|Primary|6-month Reocclusion|Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography|6 months||||participants|||Number
1288949|NCT00137969|Secondary|Number of Participants Who Achieved an MCR in The ITT Population|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.|From Weeks 24 to 52|ITT population|||participants|||Number
1288950|NCT00137969|Secondary|Change in SLE Expanded Health Survey Physical Function Score From Baseline|Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved.|From baseline to 52 weeks|ITT population|||score on a scale||Standard Deviation|Mean
1288951|NCT00137969|Secondary|Time to First Moderate or Severe Flare|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state.|52 weeks|Number of participants who ever reached C/D/E for all 8 BILAG domains before Day 364 visit. If a participant reached C/D/E at the last visit, then this participant was excluded from the analysis.|||days||95% Confidence Interval|Median
1288952|NCT00137969|Secondary|Number of Participants Who Achieved a BILAG C or Better in All Domains|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains.|24 weeks|ITT population|||participants|||Number
1288987|NCT00137423|Secondary|Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score|EQ-VAS score on the self-rated “thermometer” indicated the patient’s own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline).|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT|||score on scale||Full Range|Median
1288953|NCT00137969|Secondary|Number of Participants Who Achieved a PCR (Including MCR)|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.|From baseline to 52 Weeks|ITT population|||participants|||Number
1288954|NCT00137969|Secondary|Number of Participants Who Achieved an MCR (Excluding PCR)|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.|From baseline to 52 weeks|ITT population|||participants|||Number
1288955|NCT00137969|Secondary|Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period|"The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as:~Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks.~Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study.~Minus the Time-Adjusted AUC by the baseline BILAG global score"|From baseline to 52 weeks|ITT population|||BILAG score unit||Standard Deviation|Mean
1288956|NCT00137969|Primary|Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period|The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.|From baseline to 52 weeks|Intent-to-treat (ITT) population|||Participants|||Number
1288957|NCT00137631|Primary|Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners||6 months||||number of episodes||Standard Deviation|Mean
1288958|NCT00137631|Primary|Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners||6 months||||number of episodes||Standard Deviation|Mean
1288959|NCT00137631|Primary|Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior||6 months||||participants|||Number
1288960|NCT00137631|Primary|Number of Participants Reporting HIV Testing Behavior||6 months||||participants|||Number
1288961|NCT00137631|Primary|Any Unprotected Anal Intercourse (UAI) With Casual Partners|Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)|6 months||||Number of episodes||Standard Deviation|Mean
1288962|NCT00137449|Secondary|Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where 0.0 = death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline (includes data available for >=10 subjects).|Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study|ITT population|||score on scale||Full Range|Median
1288963|NCT00137449|Secondary|Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)|EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (Increase or Decrease from baseline) included data available for >=10 subjects.|Baseline, Day 1 &15 of each treatment cycle up to 1 year on study|ITT population.|||score on scale||Full Range|Median
1288964|NCT00137449|Secondary|Score of FACIT-Fatigue Scale|FACIT-Fatigue Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Maximum, minimum mean included data available for >=10 subjects.|Baseline, Day 1 & 15 of each treatment cycle|ITT population|||score on scale||Standard Deviation|Mean
1288965|NCT00137449|Secondary|Overall Survival (OS) and One-year Survival [Descriptive Statistics]|Overall survival is defined as time from the date of first dose of study medication to the date of death due to any cause. One year survival rate defined as the probability that a patient is alive 1 year after the date of first study medication.|Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.|ITT population (all subjects enrolled that received at least 1 dose of study medication).|||participants|||Number
1295933|NCT00075400|Other Pre-specified|c-KIT Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by Immunohistochemistry (IHC)|Potential associations with clinical or PFS response will be assessed.|Baseline|||||||
1288966|NCT00137449|Secondary|Duration of Tumor Response (DR) [Descriptive Statistics]|DR was defined as the time from the date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the date of the first documentation of objective tumor progression or to death due to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. Number of responders (AM=3, PM=5, Total=8)|||weeks||Full Range|Median
1288967|NCT00137449|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression that occurred on treatment including within 28 days after the last dose of study medication.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||participants|||Number
1288968|NCT00137449|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||participants|||Number
1288969|NCT00137449|Secondary|Duration of Stable Disease|Duration of SD is the time from the date of first documentation of stable disease to the date of first documentation of objective tumor progression or death due to any cause that occurred within 28 days after last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||Participants|||Number
1288970|NCT00137449|Secondary|Number of Participants With Overall Confirmed Objective Disease Response (ORR)|Overall confirmed objective disease response is defined as a confirmed CR, or confirmed PR according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||participants|||Number
1288971|NCT00137449|Secondary|Number of Participants by Best Confirmed Response Category According to RECIST|Best confirmed response (BCR) defined as best response [confirmed CR, confirmed PR, SD, PD(progressive disease), not evaluable (NE)] recorded from start of treatment until disease progression / recurrence. Best response of SD must have met SD criteria at least once after first dose at minimum interval of 6 weeks.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||participants|||Number
1288972|NCT00137449|Primary|Number of Participants With Clinical Benefit Response (CBR) According to RECIST|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. CR+PR+(SD for >=24 weeks)|||participants|||Number
1288973|NCT00137436|Secondary|Preliminary Assessment of PSA Modulation by SU011248|PSA modulation analyzed by the mean change in PSA response measured as ng/mL.|Baseline to Day 28|ITT population; PSA modulation was listed as a secondary endpoint for Phase 2, however, modulation was planned for analysis only for Phase 1 portion of the study. No formal analysis was completed to determine modulation.|||ng/mL||95% Confidence Interval|Mean
1288974|NCT00137436|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)|Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|PRO evaluable population; (n)=number of participants with evaluable data at observation.|||scores on a scale||95% Confidence Interval|Mean
1288975|NCT00137436|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)|The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain interference index score (to measure how much pain had interfered with daily activities) was derived from Questions 7A-7G with a range from 0 (no interference) to 10 (completely interferes); higher scores indicate more interference.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|PRO evaluable population; (n)=number of participants with evaluable data at observation.|||scores on a scale||95% Confidence Interval|Mean
1288985|NCT00137436|Secondary|Time to PSA Progression|Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date – first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir (lowest)] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT|||weeks||Full Range|Median
1288976|NCT00137436|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)|The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain intensity index score was derived from Questions 2-5 with range from 0 to 10 (0: no pain; 1-4: mild pain; 5-6: moderate pain; 7-10: severe pain); higher scores indicate worse health status.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|Patient reported outcomes (PRO) evaluable population defined as participants in the ITT population who received at least 1 dose of study medication (sunitinib or docetaxel) and had baseline data; (n)=number of participants with evaluable data at observation.|||scores on a scale||95% Confidence Interval|Mean
1288977|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3|Soluble protein biomarker VEGFR3 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT|||pg/mL||Full Range|Median
1288978|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2|Soluble protein biomarker VEGFR2 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT|||pg/mL||Full Range|Median
1288979|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC|Soluble protein biomarker VEGFC measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT|||pg/mL||Full Range|Median
1288980|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3|Soluble protein biomarker Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT|||pg/mL||Full Range|Median
1288981|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2|Soluble protein biomarker Vascular Endothelial Growth Factor receptor 2 (VEGFR2) measured as pg/mL. PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT|||pg/mL||Full Range|Median
1288982|NCT00137436|Secondary|Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC|Soluble protein biomarker Vascular Endothelial Growth Factor C (VEGFC) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT|||pg/mL||Full Range|Median
1288983|NCT00137436|Secondary|Percentage of Participants With Objective Response Rate (ORR)|Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT; N=participants with measurable disease at baseline, received at least 1 dose of study medication, and had correct histological cancer type.|||percentage of participants||95% Confidence Interval|Number
1288984|NCT00137436|Secondary|Duration of PSA Response (DPR)|Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir [lowest] and increase in absolute-value PSA level by at least 5 ng/mL [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir / lowest] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR – first PSA response + 1)/7.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT; DPR only calculated for the subgroup of patients with PSA response rate.|||weeks||Full Range|Median
1288986|NCT00137436|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.|Baseline, Day 1 of each 21-day cycle|The intent-to-treat (ITT) population was defined as all patients enrolled in the study that receive at least 1 dose of study medication (SU011248 or docetaxel)|||percentage of participants||95% Confidence Interval|Median
1288988|NCT00137423|Secondary|Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index|EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT|||score on scale||Full Range|Median
1288989|NCT00137423|Secondary|Summary of FACIT Fatigue Scale Overall Score|FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT; Results summarized by cohort & time point through Cycle 13 (the last cycle for which more than 3 subjects completed the questionnaire on either arm). If more than 50% of the items in the scale were answered, then missing items were imputed with the mean of the non-missing items scored at that visit. Outcome based on completed questionnaires.|||score on scale||Standard Deviation|Mean
1288990|NCT00137423|Secondary|Overall Survival|Overall survival is time from the date of first dose of medication to the date of death due to any cause|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; Patients who are alive at the time of analysis or who are lost to follow up are censored on the last date they were known to be alive. Estimates are based on the Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley method. n=54,53(AM,PM).|||weeks||95% Confidence Interval|Median
1288991|NCT00137423|Secondary|Progression Free Survival (PFS)|Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; Calculation based on subgroup of patients with baseline disease assessment, measurable disease at baseline, correct histological type and are refractory to cytokine. Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. N=53,52(AM,PM).|||weeks||95% Confidence Interval|Median
1288992|NCT00137423|Secondary|Time to Tumor Progression (TTP)|Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT;TTP calculated based on subgroup with baseline disease assessment, measurable disease at baseline, correct histological type and refractory to cytokine.Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. n=53,52(AM,PM).|||weeks||95% Confidence Interval|Median
1288993|NCT00137423|Secondary|Duration of Tumor Response|Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; DR time from start of 1st documentation of objective tumor response to 1st documentation of objective tumor progression or death & calculated for the subgroup of subjects with a confirmed objective tumor response. Descriptive statistics for responders who had an event. Total number responders n= 15,6(AM,PM). Response duration n=7,3(AM,PM).|||weeks||Full Range|Median
1288994|NCT00137423|Primary|Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects|Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; CR,PR calculated from patients with measurable disease at baseline+correct histological cancer type+ refractory to prior cytokine-based therapy n= 53,52 (AM,PM)|||participants|||Number
1288995|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes|Chi-square analysis was used to examine competitive employment gained during treatment in implementation versus control groups. The dependent variable was competitive employment. Individuals included were only those who expressed interest in returning to work at both the baseline and follow-up interview time-points.|1 year||||competitive employment|||Number
1288996|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization|The number of participants with one or more Supported Employment appointments in the one year during implementation (implementation sites versus control sites) for those participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services). This only includes participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services).|1 year||||participants|||Number
1289011|NCT00137046|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity measured in liters (L).|Week -3 through Extension Follow-up Month 6 or End of Study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and TLC results were not summarized as planned.|||liters||Standard Deviation|Mean
1288997|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes|Analysis of Covariance (ANCOVA) was used to examine weight gained during treatment in implementation versus control groups. The dependent variable was final weight. Baseline weight, weight 6 months prior to baseline, and baseline psychotic and negative symptom subscales were included as covariates. The inclusion of weight 6 months prior to baseline served to control for subjects’ weight gain/loss trajectories prior to entering the study. The two-way interactions of group by covariates were also included in the model.|1 year||||pounds||Standard Error|Least Squares Mean
1288998|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization|The number of participants with one or more weight service appointments in the one year during implementation (implementation sites versus control sites) for those participants who were overweight at the baseline interview (e.g., eligible for weight services). This only includes participants who were overweight at the baseline interview (e.g., eligible for weight services).|1 year||||participants|||Number
1288999|NCT00137267|Secondary|Number of Days Engaged|Number of days veteran was involved with the program, from initial consent to last day of contact|8 weeks||||Days engaged in program||Standard Deviation|Mean
1289000|NCT00137267|Primary|Treatment Engagement|Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period|8 weeks||||number of treatment sessions attended||Standard Deviation|Mean
1289001|NCT00137111|Other Pre-specified|Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells|Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of NLRP3 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.|Pre-treatment|One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and NLRP3 expression in RNA by MTT assay|||arbitrary units||Inter-Quartile Range|Median
1289002|NCT00137111|Other Pre-specified|Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells|Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.|Pre-treatment|One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay.|||arbitrary units||Inter-Quartile Range|Median
1289003|NCT00137111|Secondary|Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)|"White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count~Measurement: Percentage change of leukemia cells from baseline"|Immediately before the methotrexate infusion and three days after subsequent infusion|Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate’s antileukemic effects.|||Percent change||Standard Deviation|Mean
1289004|NCT00137111|Secondary|Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).|Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.|42 hours after start of high dose methotrexate infusion (HDMTX)|The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .|||pmol/1,000,000,000 cells||Standard Deviation|Mean
1289005|NCT00137111|Secondary|Minimal Residual Disease (MRD)|Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%).|End of Induction (Day 46 MRD measurement)|Patients who completed induction and had successful MRD studies on day 46.|||participants|||Number
1289006|NCT00137111|Primary|Continuous Complete Remission Since Week 56 Therapy.|CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.|Median follow up time (range) 4.5 (1 to 7.8) years|Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000.|||Percentage of participants|||Number
1289007|NCT00137111|Primary|Overall Event-free Survival (EFS)|EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.|Median follow-up time (range) 5.6 (1.3 to 8.9) years|498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy.|||Percentage of Participants|||Number
1289008|NCT00137046|Secondary|Insulin Antibodies|Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).|Baseline through Extension Month 39|FAS; (n)= number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.|||microU/mL||Full Range|Median
1289009|NCT00137046|Primary|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)|Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).|Week -2 through Extension Follow-up Month 6 or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the annual rate of change in DLco were not summarized as planned.|||ml/min/mmHg/yr||Standard Deviation|Mean
1289010|NCT00137046|Primary|Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)|Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).|Week -2 through Extension Follow-up Month 6 or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Annual Rate of Change in FEV1 were not summarized as planned.|||liters per year||Standard Deviation|Mean
1289013|NCT00137046|Primary|Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).|Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.|Month 3 through Extension Follow-up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||participants|||Number
1289014|NCT00137046|Primary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)|Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity [DLco] measured in milliters/minutes/millimeters of mercury [mL/min/mmHg] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Due to study termination, originally planned inferential analysis change from Month 3 to extension Month 60 was not done.|||mL/min/mmHg||Standard Deviation|Mean
1289015|NCT00137046|Secondary|Cough Questionnaire|Subject completed cough questionnaire with reference to the past 4 weeks. Six question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (subcutaneous [SC] or inhaled), and productivity of cough; range 0 (no symptoms) to 4 (severe symptoms). Questionnaire was administered at Week 0 and then at subsequent visits only if cough was identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.|Week 0 and if indicated through Extension Follow up Month 3|FAS. Due to early termination of the study a limited set of analyses were undertaken and results of the Cough Questionnaire were not summarized as planned.|||scores on scale||Standard Deviation|Mean
1289016|NCT00137046|Secondary|Lipids|Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides measured as milligrams per deciliter (mg/dL).|Week -4 through Month 24|Full Analysis Set (FAS): received at least 1 dose of study treatment. Due to early termination of the study a limited set of analyses were undertaken and lipid results were not summarized as planned.|||mg/dL||Standard Deviation|Mean
1289017|NCT00137046|Secondary|Transition Dyspnea Index (TDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.|Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Transition Dyspnea Index were not summarized as planned.|||scores on scale||Standard Deviation|Mean
1289018|NCT00137046|Secondary|Baseline Dyspnea Index (BDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment.|Week - 1|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Baseline Dyspnea Index were not summarized as planned.|||scores on scale||Standard Deviation|Mean
1289019|NCT00137046|Secondary|Total Daily Short-Acting Insulin Dose Adjusted for Body Weight|Total Daily Short-Acting Insulin Dose adjusted for body weight (milligrams [mg] or units divided by kilograms [kg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg/kg, units/kg||Standard Deviation|Mean
1289020|NCT00137046|Secondary|Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg, units||Standard Deviation|Mean
1289021|NCT00137046|Secondary|Total Daily Long-Acting Insulin Dose Adjusted for Body Weight|Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||units/kg||Standard Deviation|Mean
1289022|NCT00137046|Secondary|Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)|Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight; long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||units||Standard Deviation|Mean
1289023|NCT00137046|Secondary|Change From Baseline Body Weight|Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus mean baseline body weight.|Baseline through Extension Follow-up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||kilograms||Standard Deviation|Mean
1289024|NCT00137046|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from Baseline: mean of (value of fasting plasma glucose [milligrams per deciliter (mg/dL)] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg/dL||Standard Deviation|Mean
1289045|NCT00136916|Secondary|Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)|Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg).|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg/kg, units/kg||Standard Deviation|Mean
1289025|NCT00137046|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months * 100.|Month 1 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||events / subject months * 100|||Number
1289026|NCT00137046|Secondary|Hypoglycemic Event Rates|A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment.|Month 1 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||total events/subject months|||Number
1289027|NCT00137046|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from Baseline: mean of (value of Glycosylated Hemoglobin [HbA1c] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||percent||Standard Deviation|Mean
1289028|NCT00137046|Primary|Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)|Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.|Month 3 through Extension Follow-up 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||participants|||Number
1289029|NCT00137046|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|Full Analysis Set (FAS) FEV1: received at least 1 dose of study drug, had a Baseline FEV1, and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.|||liters||Standard Deviation|Mean
1289030|NCT00136955|Secondary|Overall Survival (OS) and Time to Tumor Progression (ITT Population)|TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.|Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.|Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.|||days||95% Confidence Interval|Median
1289031|NCT00136955|Primary|Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)|Tumor response according to RECIST.|At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)|Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.|||participant|||Number
1289032|NCT00136955|Secondary|Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)|TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.|Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.|Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.|||days||95% Confidence Interval|Median
1289033|NCT00136955|Primary|Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)|Tumor response according to RECIST.|At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)|Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.|||participant|||Number
1289034|NCT00136916|Secondary|Insulin Antibodies|Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).|Baseline through extension Month 36|FAS; (n)=number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.|||microU/mL||Full Range|Median
1289046|NCT00136916|Secondary|Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)|Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg, units||Standard Deviation|Mean
1289035|NCT00136916|Secondary|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits|"Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. No response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn)."|Baseline, M12, M24, Ext M6, Ext M18, Ext M36|All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.|||participants|||Number
1289036|NCT00136916|Secondary|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits|Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline.|Baseline, M12, M24, Ext M6, Ext M18, Ext M36|All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.|||participants|||Number
1289037|NCT00136916|Secondary|Transition Dyspnea Index (TDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (–9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.|Week 4 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TDI were not summarized as planned.|||scores on scale|||Number
1289038|NCT00136916|Secondary|Baseline Dyspnea Index (BDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0–12). Lower score indicates greater impairment.|Week -1|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of BDI were not summarized as planned.|||scores on scale|||Number
1289039|NCT00136916|Secondary|Cough Questionnaire|Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.|Week 0 and if indicated through extension follow up Month 3|FAS. Due to early termination of study a limited set of analyses were undertaken and results of Cough Questionnaire were not summarized as planned.|||scores on scale|||Number
1289040|NCT00136916|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval.|Month 1 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||event rate (events/subject months*100)|||Number
1289041|NCT00136916|Secondary|Hypoglycemic Event Rates|Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval).|Month 1 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||event rate (events/subject months)|||Number
1289042|NCT00136916|Primary|Summary of ≥ 20 % Decliners in DLco|Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.|Month 3 through extension follow up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||participants|||Number
1289043|NCT00136916|Primary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)|Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS FEV1; extension M36 LOCF based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure Annual rate of change in Carbon Monoxide Diffusion Capacity (DLco).|||ml/min/mmHg||Standard Deviation|Mean
1289044|NCT00136916|Secondary|Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides|Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL).|Week -4 through Month 24|FAS: received at least 1 dose of study treatment. Due to early termination of study a limited set of analyses were undertaken and results of Lipids were not summarized as planned.|||mg/dL||Standard Deviation|Mean
1289047|NCT00136916|Secondary|Total Daily Long-acting Insulin (Adjusted for Body Weight)|Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||units/kg||Standard Deviation|Mean
1289048|NCT00136916|Secondary|Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)|Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||units||Standard Deviation|Mean
1289049|NCT00136916|Secondary|Change From Baseline in Body Weight|Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||kg||Standard Deviation|Mean
1289050|NCT00136916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg/dL||Standard Deviation|Mean
1289051|NCT00136916|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||percent||Standard Deviation|Mean
1289052|NCT00136916|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity measured in liters (L).|Baseline through extension follow up Month 3|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TLC were not summarized as planned.|||L||Standard Deviation|Mean
1289053|NCT00136916|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) measured in liters (L).|Week -3 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of FVC were not summarized as planned.|||L||Standard Deviation|Mean
1289054|NCT00136916|Primary|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)|Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).|Week -2 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in DLco were not summarized as planned. Cross reference outcome measure: change from baseline in Carbon Monoxide Diffusion Capacity (DLco).|||ml/min/mmHg/yr||Standard Deviation|Mean
1289055|NCT00136916|Primary|Summary of ≥ 15 % Decliners in FEV1|Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.|Month 3 through extension follow up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||participants|||Number
1289056|NCT00136916|Primary|Annual Rate of Change in FEV1|Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).|Week -2 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in FEV1 were not summarized as planned.|||L/yr||Standard Deviation|Mean
1289057|NCT00136916|Primary|Change From Baseline in FEV1|Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS FEV1; extension Month 36 (M36) Last Observation Carried Forward (LOCF) based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure: change from Month 3 in forced expiratory volume in 1 second.|||L||Standard Deviation|Mean
1289058|NCT00136916|Primary|Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)|Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value).|Month 3 through extension Month 60|Full analysis set (FAS) FEV1: received at least 1 dose treatment, had baseline and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.|||L||Standard Deviation|Mean
1289059|NCT00136838|Other Pre-specified|Craving|Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).|immediately following cue expose||||units on a scale (0-70)||Standard Error|Mean
1289060|NCT00136838|Primary|Cigarette Choice After 3 Day Abstinence|Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices|During Day 4 experimental session||||number of cigarette choices (0-6)||Standard Error|Mean
1289061|NCT00136812|Primary|7 Day Point Prevalence of Cigarette Abstinence||3 mo, 6 mo, 12 mo, and 18 mo post-baseline||||% quit||95% Confidence Interval|Number
1289062|NCT00136760|Secondary|Cigarettes Smoked Per Day||3 weeks||||cigarettes per day||Standard Deviation|Mean
1289063|NCT00136760|Primary|Urinary Cotinine|Urinary Cotinine levels at Week 4 (average of last 3 study visits)|3 weeks||||ng/ml||Standard Deviation|Mean
1289064|NCT00136695|Primary|Lean Body Mass||1 year||||grams||Standard Deviation|Mean
1289065|NCT00136604|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to one month Post-Booster vaccination|The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.|||Participants|||Count of Participants
1289087|NCT00136604|Primary|Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value|Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).|One Month Post-Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT versus Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix groups.|||Percentage|||Number
1289066|NCT00136604|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.|||Participants|||Count of Participants
1289067|NCT00136604|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.|||Participants|||Count of Participants
1289068|NCT00136604|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0 to Day 3) post-vaccination period|The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.|||Participants|||Count of Participants
1289069|NCT00136604|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||mIU/ml||95% Confidence Interval|Geometric Mean
1289070|NCT00136604|Secondary|Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value|Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||Percentage|||Number
1289071|NCT00136604|Secondary|Anti-BPT Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||EL.U/ml||95% Confidence Interval|Geometric Mean
1289072|NCT00136604|Secondary|Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value|Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).|One month Post-Booster vaccination|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||Percentage|||Number
1289073|NCT00136604|Secondary|Anti-TT Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||IU/mL||95% Confidence Interval|Geometric Mean
1289074|NCT00136604|Secondary|Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values|Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||Percentage|||Number
1289075|NCT00136604|Secondary|Anti-D Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||IU/mL||95% Confidence Interval|Geometric Mean
1289114|NCT00135707|Secondary|Neonatal Hospital Stay||Birth through discharge from hospital|Live born infants|||days||Inter-Quartile Range|Median
1289115|NCT00135707|Secondary|Apgar Score <=3 at 5 Minutes||At birth||||participants|||Number
1289116|NCT00135707|Secondary|Retinopathy of Prematurity||Within 1 month of birth|Live born infants|||Participants|||Count of Participants
1289117|NCT00135707|Secondary|Necrotizing Enterocolitis||Delivery through discharge|Live born infants|||Participants|||Count of Participants
1289076|NCT00136604|Secondary|Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values|Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were < 0.1 IU/ml when assessed by ELISA.|One month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination.|||Percentage|||Number
1289077|NCT00136604|Secondary|Anti-PSA Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.|||µg/ml||95% Confidence Interval|Geometric Mean
1289078|NCT00136604|Secondary|Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values|Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.|||Percentage|||Number
1289079|NCT00136604|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.|||µg/ml||95% Confidence Interval|Geometric Mean
1289080|NCT00136604|Secondary|Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values|Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.|||Percentage|||Number
1289081|NCT00136604|Secondary|Anti-rSBA-MenA Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.|||Titers||95% Confidence Interval|Geometric Mean
1289082|NCT00136604|Secondary|Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values|"Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128.~Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype)."|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.|||Percentage|||Number
1289083|NCT00136604|Secondary|Anti-SBA-MenC Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.|||Titers||95% Confidence Interval|Geometric Mean
1289084|NCT00136604|Secondary|Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values|Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.|||Percentage|||Number
1289085|NCT00136604|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1289086|NCT00136604|Secondary|Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values|Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.|||Percentage|||Number
1289118|NCT00135707|Secondary|Sepsis||Delivery through discharge|Live born infants|||Participants|||Count of Participants
1289119|NCT00135707|Secondary|Intraventricular Hemorrhage, Grade III or IV||Delivery through discharge|Live born infants|||Participants|||Count of Participants
1289120|NCT00135707|Secondary|Respiratory Distress Syndrome||Delivery through discharge|Live born infants|||Participants|||Count of Participants
1289088|NCT00136604|Primary|Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value|"Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.~Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype)."|One Month Post-Booster vaccination at 15-24 months of age|The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group only.|||Percentage|||Number
1289089|NCT00136604|Primary|Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value|Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.|One month Post-Booster vaccination at 15-24 months of age|The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group versus TRITANRIX-HEPB+Mencevax + Meningitec Group.|||Percentage|||Number
1289090|NCT00136357|Primary|Harvard Trauma Questionnaire|The Harvard Trauma Questionnaire measures PTSD Symptoms. This scale has 16 items and is rated on a Likert scale from 1-4. The total score is sum of the scores divided by the number of items. Higher scores indicated higher levels of PTSD symptoms.|Baseline, 12 weeks, 3 months||||units on a scale||Standard Deviation|Mean
1289091|NCT00136318|Secondary|Safety||assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment|||||||
1289092|NCT00136318|Secondary|Tolerability||assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment|||||||
1289093|NCT00136318|Secondary|Sustained Virologic Response|(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)|assessed 24 weeks after end of antiviral treatment|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.|||percentage of participants||95% Confidence Interval|Number
1289094|NCT00136318|Secondary|Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)||assessed 2,4,12,24 and 48 weeks of antiviral treatment|||||||
1289095|NCT00136318|Secondary|Severe Depression Defined as a MADRS Score of 25 or Higher||severe depression during 24 or 48 weeks of antiviral therapy|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.|||percentage of participants||95% Confidence Interval|Number
1289096|NCT00136318|Secondary|Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria||major depression during 24 or 48 weeks of antiviral therapy|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.|||percentage of participants||95% Confidence Interval|Number
1289097|NCT00136318|Secondary|Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)|Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression|Patients free of depression during 24 or 48 weeks of antiviral therapy|Number of patients per group who did not develop any depressive episode during 48 weeks of antiviral therapy.|||participants|||Number
1289098|NCT00136318|Primary|Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher|"Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as percentage of participants with MADRS scores > 13 (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)"|50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3|The final analysis included only patients who received at least one of escitalopram or placebo. Between group differences for the primary outcome parameters were calculated with a chi-square test. For the primary end point (MADRS score of 13 or higher), we treated missing MADRS assessments by multiple imputation.|||percentage of participants||95% Confidence Interval|Number
1289099|NCT00136214|Primary|Neurocognitive Tests for Cerebral Function|A battery of pen and paper neurocognitive tests where subject means are reported compared to the normative Z score. Data is reported at baseline (T1), week 12 on treatment (T2) and 12 weeks after treatment (week 60, T3). Improvements are increases in the test result compared to baseline as determined against the Z score. tests performed included Hopkins learning trials (HVLT), a measure of of verbal learning and memory and the Roy-Osterrieth Complex figure test (ROCF) which evaluates visio-spatal abilities, memory, planning and working memory. Improvements in the score (increases in value compared, either less negative or more positive to the Z score) shown in the table are reflective of improvements in these neurocognitive parameters.|18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline and only done in treated group and not controls||||Z-score||Standard Deviation|Mean
1289100|NCT00136214|Primary|Ratios of Cerebral Metabolites Choline (CH), Myoinisitol (MI) and N-acety Aspartate (NAA)to Creatine (Cr) in 3 Brain Regions Including Basal Ganglia, Frontal Cortex and Left Dorsolateral Prefrontal Cortex|Evaluation of changes in MR spectroscopy. reductions in ratio of Cho and MI reflect improvements in cerebral inflammation and improvement in cognition. Increases in the NAA ratio are suggestive of improvement in cognitive function.|18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline|One patient dropped out secondary to claustrophobia and was unable to complete MR portion of study|||ratio||Standard Deviation|Mean
1289121|NCT00135707|Secondary|Admission to NICU|NICU denotes neonatal intensive care unit.|Delivery through discharge|Live born infants|||Participants|||Count of Participants
1289122|NCT00135707|Secondary|Birth Weight <2500 Grams||At birth|Live born infants|||Participants|||Count of Participants
1289123|NCT00135707|Secondary|Small for Gestational Age|A baby whose birth weight is less than the 3rd percentile is considered to be small for gestational age (adjusted for sex and race or ethnic group)|At birth|Live born infants|||Participants|||Count of Participants
1289124|NCT00135707|Secondary|Birth Weight||At birth|Liveborn infants|||grams||Standard Deviation|Mean
1289101|NCT00136084|Secondary|Relationship of Inhibition of DNA Synthesis and Clinical Response|Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis.|Measurements were assessed in Induction I chemotherapy|Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. 17 of the 21 patients had evaluable day 22 MRD.|||Percent inhibition of DNA Synthesis||Standard Error|Mean
1289102|NCT00136084|Secondary|To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy|Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.|Measurements were assessed in Induction I chemotherapy|Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.|||Percent Inhibition of DNA Synthesis||Standard Error|Mean
1289103|NCT00136084|Secondary|To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy|Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up|Five Year|238 patients were enrolled on the study. Out of 238, 6 were determined to be ineligible and 2 were not randomized. Of the 230 patients, 14 bi-phenotypic leukemia patients were excluded. 216 AML patients were included to estimate EFS.|||Percentage of Participants|||Number
1289104|NCT00136084|Secondary|Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.|To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy|Induction II|30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.|||Participants|||Number
1289105|NCT00136084|Secondary|Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO|To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy.|Induction II|Out of the 30 patients received ADE + GO treatment, one patient had inevaluable MRD prior to and after the treatment. 29 patients were analyzed. Out of the 29 patients, 10 patients were treated on HDAC arm and 19 patients were treated on LDAC arm.|||Participants|||Number
1289106|NCT00136084|Secondary|Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)|To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)|Consolidation I|Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm.|||Participants|||Number
1289107|NCT00136084|Primary|Minimal Residual Disease (MRD).|Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%).|Day 22 MRD measurement|Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.|||participants|||Number
1289108|NCT00135798|Secondary|Patients With Combined Virologic Response (CVR): Per-Protocol Analysis (PP)|Per-Protocol (PP) analyses of all patients. Combined Virologic Response (CVR)includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR), analysed among patients who received treatment.|Pre-transplant and 3 months post-transplant|All study patients|||participants|||Number
1289109|NCT00135798|Primary|Patients Who Are Negative for HCV RNA at 3 Months Post-transplant: Per-Protocol Analysis (PP)|Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation, analysed among patients who received treatment.|3 months post-transplant|Per-Protocol (PP) analyses of Transplanted patients who received treatment. Outcome is pTVR (post-transplant viral response)|||participants|||Number
1289110|NCT00135798|Secondary|Patients With Combined Virologic Response (CVR): Intent-to-Treat Analyses (ITT)|Intent-to-Treat (ITT) analyses of all patients. Combined Virologic Response (CVR), which includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR)|Pre-transplant and 3 months post-transplant|All study patients|||participants|||Number
1289111|NCT00135798|Primary|Patients Who Are Negative for Hepatitis C Virus (HCV) RNA at 3 Months Post-transplant: Intent-to-Treat Analysis (ITT)|Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation.|3 months post-transplant|Intent-to-Treat (ITT) analyses of Transplanted patients assigned to treatment. Outcome is pTVR (post-transplant viral response)|||participants|||Number
1289112|NCT00135707|Post-Hoc|Analysis of Primary Composite Outcome in Participants Randomized Before the 13th Week of Pregnancy|Subgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized before the 13th week of pregnancy.|During pregnancy||||Participants|||Count of Participants
1289113|NCT00135707|Post-Hoc|Analysis of Primary Composite Outcome in Participants Randomized on or After the 13th Week of Pregnancy|Subgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized on or after the 13th week of pregnancy.|During pregnancy||||Participants|||Count of Participants
1289141|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death|Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge or prior to discharge following delivery admission||||Participants|||Count of Participants
1289142|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the 3rd Percentile) Adjusted for Sex and Race or Ethnic Group|Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
1289143|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders|Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
1289144|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure|Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
1289145|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level|Elevated serum creatinine defined as ≥1.5 mg per deciliter or 132.6 μmol per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
1289146|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia|Thrombocytopenia defined as a platelet count of <100,000 per cubic millimeter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||participants|||Number
1289147|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels|Elevated liver enzyme levels are specified as an aspartate aminotransferase level of >= 100 U per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
1289148|NCT00135707|Primary|Severe Hypertension|Included here are women who had severe hypertension only and those who had severe hypertension with elevated liver enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or fetal death after 20 weeks of gestation, or neonatal death.|20 weeks through discharge following delivery||||Participants|||Count of Participants
1289149|NCT00135707|Primary|Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate|Severe hypertension (blood pressure [BP]>= 160/110) or mild hypertension (BP>= 140/90) >= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death|20 weeks through discharge following delivery|The analysis was intent to treat.|||Participants|||Count of Participants
1289150|NCT00135694|Secondary|Total Burden of Immunosuppression From Random Assignment to Month 24|Total immunosuppression score in units taken as the sum of units per day over the 2-year period from randomization to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.).|Randomization to Month 24 post-randomization|Randomized participants still being followed 24 months post-randomization.|||units||Full Range|Mean
1289151|NCT00135694|Secondary|Total Immunosuppression From Month 21 to Month 24 Post-randomization|Daily immunosuppression score in units per day averaged over the 3-month period from Month 21 to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.)|Month 21 to Month 24 post-randomization|Randomized participants still being followed 24 months post-randomization.|||units per day||Full Range|Mean
1289152|NCT00135694|Secondary|Number of Participants Experiencing Graft Loss or Death|Number of participants with graft loss or death. Graft loss is defined as subject death or re-transplantation.|Randomization to 2 years post-randomization.|Randomized participants (intent-to-treat sample)|||participants|||Number
1289153|NCT00135694|Secondary|Number of Hepatitis C Infected Participants With Progression of Hepatitis C Related Liver Disease, Defined as Stage 4 or Higher Fibrosis on the Ishak Scale|Number of subjects with a biopsy showing stage 4 fibrosis or higher on the Ishak scale. Stage 4 represents at least 13.7% fibrosis measurement with a description of fibrous expansion of portal areas with marked bridging (P-P) as well as portal to central (P-C). Stage 5 is marked bridging (P-P and/or P-C), with occasional nodules (incomplete cirrhosis) and stage 6 is cirrhosis, probable or definite.|Randomization to 2 years post-randomization.|Hepatitis C infected participants randomized.|||participants|||Number
1295934|NCT00075400|Other Pre-specified|p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue|Potential associations with clinical or PFS response will be assessed.|Baseline|||||||
1289154|NCT00135694|Secondary|Immunosuppression-free Duration|Time (in days) from withdrawing off of all immunosuppressive drugs to re-starting immunosuppression or study termination/completion.|Discontinuation of all immunosuppression to end of trial participation or to time of restarting immunosuppression, whichever came first, assessed up to two years|Participants randomized to immunosuppression withdrawal who completed withdrawal and discontinued all immunosuppression|||Days||Full Range|Mean
1289155|NCT00135694|Secondary|Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months||Randomization until study completion or participant termination (up to six years post-transplant)|Participants randomized to immunosuppression withdrawal|||participants|||Number
1289156|NCT00135694|Secondary|Number of Participants Who Qualify for Random Assignment||One to two years post-transplantation|All subjects transplanted|||participants|||Number
1289157|NCT00135694|Primary|Number of Participants With Clinical Complications Usually Attributed to Immunosuppression|This is a composite endpoint comprising clinical complications related to immunosuppression and is defined as the occurrence of any of the following: death or graft loss, grade 4 secondary malignancy (graded by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), grade 4 opportunistic infection (graded by CTCAE version 3.0), stage 3 or higher fibrosis, or decrease in renal function. Decrease in renal function is defined as: a) the estimated glomerular filtration rate (eGFR) using creatinine obtained prior to and closest to randomization will be considered the baseline and will be compared to the eGFR using creatinine obtained at 24 months +/- 3 months after randomization; b) for those with a baseline eGFR 30-90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR; c) for those with a baseline eGFR greater than 90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR and a decrease in eGFR to less than 90 ml per min per 1.73 meter-squared.|Randomization to 2 years post-randomization|Evaluable randomized subjects having a targeted event and/or having available data for calculation of eGFR|||participants|||Number
1289158|NCT00135356|Secondary|Mean Change From Baseline in CD4 Count|Mean change from baseline in CD4 count among treated subjects|Baseline, Week 48, Week 96|Observed Cases (OC)|||cells/mm3||Standard Error|Mean
1289159|NCT00135356|Secondary|Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline|Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval.|Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96|Treated subjects with HIV RNA <400 c/mL at baseline.|||Proportion of participants|||Number
1289160|NCT00135356|Secondary|Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation|Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record).|Through Week 96|Treated subjects|||Percent of Participants|||Number
1289161|NCT00135356|Secondary|Percentage of Participants With Abnormal Liver Function Tests|Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling.|Week 48, Week 96|All treated participants|||Percentage of Participants|||Number
1289162|NCT00135356|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Through Week 96 of study therapy|Treated participants|||Percentage of Participants|||Number
1289163|NCT00135356|Secondary|Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96|Mean changes from baseline in proportion of waist to hip measurements.|Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint|||ratio||Standard Error|Mean
1289164|NCT00135356|Secondary|Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint|||kg/m2||Standard Error|Mean
1289165|NCT00135356|Secondary|Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint|||cm||Standard Error|Mean
1289166|NCT00135356|Secondary|Mean Changes From Baseline in Body Weight at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint|||kg||Standard Error|Mean
1289167|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance.|Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.|||mg/dL x uU/mL||Standard Error|Mean
1289168|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96||Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.|||microunits per milliliter||Standard Error|Mean
1289169|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96||Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.|||mg/dL||Standard Error|Mean
1289170|NCT00135356|Secondary|Mean Percent Changes From Baseline in Fasting Lipids|Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B|Baseline, Week 48, Week 96|Treated Subjects (LOCF). n=56 for LDL cholesterol in the PI/RTV arm at both timepoints|||Percent change|||Number
1289171|NCT00135356|Secondary|Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans|The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other [weight, etc]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|TAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint|||percent change||Inter-Quartile Range|Mean
1289172|NCT00135356|Secondary|Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans|The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|SAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before analysis timepoint.|||percent change||Inter-Quartile Range|Mean
1289173|NCT00135356|Secondary|Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.|The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|VAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint.|||Percent change||Inter-Quartile Range|Mean
1289174|NCT00135356|Secondary|Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)|Baseline, Week 96|Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.|||ratio||Standard Error|Mean
1289175|NCT00135356|Primary|Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48|Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)|Baseline, Week 48|Treated participants. Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.|||ratio||Standard Error|Mean
1289176|NCT00135330|Secondary|Pedal Edema Score|"Pedal edema scores experienced by each patient throughout the study (1+ indicates a patient experienced a pedal edema score of 1 , 2, or 3; 2+ indicates a patient experienced a pedal edema score of 2 or 3, etc.)~Scale:~Slight pitting, no visible distortion, disappears rapidly~A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 – 15 seconds~The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen~The pit is very deep, lasts as long as 2 – 5 minutes, and the dependent extremity is grossly distorted"|20 weeks|Full Analysis Set|||participants|||Number
1289177|NCT00135330|Secondary|Hypoglycemia Rate Per 30 Days Per Patient|Average number of episodes of hypoglycemia per 30 days per patient|20 weeks|Full Analysis Set|||hypoglycemia events / 30 days / patient||Standard Deviation|Mean
1289178|NCT00135330|Secondary|Incidence of Hypoglycemia Events|Number of subjects experiencing hypoglycemia at any point during the study|20 weeks|Full Analysis Set|||participants|||Number
1289179|NCT00135330|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set|||ratio (cm/cm)||Standard Error|Least Squares Mean
1289180|NCT00135330|Secondary|Change in Hip Circumference|Change in hip circumference form baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set|||cm||Standard Error|Least Squares Mean
1289181|NCT00135330|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set|||cm||Standard Error|Least Squares Mean
1289182|NCT00135330|Secondary|Change in Lean Body Mass During a Meal Challenge Test (MCT)|Change in lean body mass from baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements|||kg||Standard Error|Least Squares Mean
1289183|NCT00135330|Secondary|Change in Body Fat Mass During a Meal Challenge Test (MCT)|Change in body fat mass form baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements|||kg||Standard Error|Least Squares Mean
1289184|NCT00135330|Secondary|Change in Percent Body Fat During a Meal Challenge Test (MCT)|Change in percent body fat from baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurement|||percentage||Standard Error|Least Squares Mean
1289185|NCT00135330|Secondary|Change in Fasting Triglycerides|Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set|||mmol/L||Standard Error|Geometric Mean
1289187|NCT00135330|Secondary|Change in Fasting HDL Cholesterol|Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||mmol/L||Standard Error|Least Squares Mean
1289188|NCT00135330|Secondary|Change in Fasting Total Cholesterol.|Change in fasting total cholestrol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||mmol/L||Standard Error|Least Squares Mean
1289189|NCT00135330|Secondary|Change in Body Weight|Change in body weight from baseline to week 20.|Week 20|All patients who aave both baseline and at least one post baseline value in full analysis set.|||kg||Standard Error|Least Squares Mean
1289190|NCT00135330|Secondary|Change in Fasting Proinsulin|Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||pmol/L||Standard Error|Geometric Mean
1289191|NCT00135330|Secondary|Change in Fasting Insulin|Change in fasting insulin from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||uIU/ml||Standard Error|Geometric Mean
1289192|NCT00135330|Secondary|Change in Fasting C-peptide|Change in fasting C-peptide from baseline to week 20.|Week 20|Fasting C-peptide was initially identified as an outcome measure, but data for this measure were not subsequently collected at baseline or endpoint.||||||
1289193|NCT00135330|Secondary|Change in Fasting Serum Glucose Concentration.|Change in fasting serum glucose concentration from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||mmol/L||Standard Error|Least Squares Mean
1289194|NCT00135330|Secondary|Change in HbA1c|Change in HbA1c from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||Percentage||Standard Error|Least Squares Mean
1289195|NCT00135330|Secondary|Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).|Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.|Week 20|All patients in full analysis set who have baseline and endpoint measurement.|||mmol/L||Standard Error|Least Squares Mean
1289196|NCT00135330|Secondary|Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).|Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||mmol/L||Standard Error|Least Squares Mean
1289197|NCT00135330|Secondary|Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).|Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||mmol/L||Standard Error|Least Squares Mean
1289198|NCT00135330|Secondary|Change in AUC for C-peptide During a Meal Challenge Test (MCT).|Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||nmol-min/L||Standard Error|Geometric Mean
1289199|NCT00135330|Secondary|Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).|Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||uIU-min/ml||Standard Error|Geometric Mean
1289200|NCT00135330|Secondary|Change in Insulin iAUC From Baseline to Endpoint.|"Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. First stage represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test."|Week 20|All patients in full analysis set who participated in clamp tests and have both baseline and endpoint.|||uIU-min/ml||Standard Error|Least Squares Mean
1289201|NCT00135330|Secondary|Change in Insulin AUC in the First Stage From Baseline to Endpoint.|"Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. First stage represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test."|Week 20|All patients in full analysis set who participated in clamp tests and have both baseline and endpoint|||uIU-min/ml||Standard Error|Least Squares Mean
1289202|NCT00135330|Secondary|Change in Insulin Sensitivity Index as Measured by M-value.|Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.|Week 20|All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.|||mg/kg-min||Standard Error|Least Squares Mean
1289203|NCT00135330|Secondary|Change in AUC for Glucose During a Meal Challenge Test (MCT).|Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||mmol-min/L||Standard Error|Least Squares Mean
1289204|NCT00135330|Primary|Change in ASIiAUC During a Hyperglycemic Clamp Test.|Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.|20 weeks|All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.|||uIU-min/ml||Standard Error|Least Squares Mean
1289205|NCT00135200|Secondary|Time to Treatment Failure||3-6 months|||||||
1289206|NCT00135200|Secondary|Progression Free Survival Time||3-6 months|||||||
1289207|NCT00135200|Secondary|Duration of Response||3-6 months|||||||
1289208|NCT00135200|Secondary|Number of Participants With Complete Response (CR)|"Determine the rate of conversion to complete response (CR). CR requires all of the following:~Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.~Less than 5% plasma cells in the bone marrow on at least 2 determinations. Repeat bone marrow is not required for patients with secretory myeloma who have sustained absence of monoclonal protein on immunofixation.~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).~Disappearance of all soft tissue plasmacytomas.~Patients in whom some, but not all the criteria for CR are fulfilled are classified as nCR or PR or VGPR (see below), providing the remaining criteria for nCR, VGPR, or PR are satisfied."|6 months||||participants|||Number
1289209|NCT00135200|Primary|Percentage of Patients With an Objective Response|"The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level.~An objective response may be:~Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations.~Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations.~Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation."|3 months||||percentage of patients||95% Confidence Interval|Number
1289210|NCT00134901|Primary|Weekly Cocaine Use|Mean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.|weekly use during length of study participation||||days||Standard Deviation|Mean
1289211|NCT00134901|Secondary|Cocaine Abstinence Based on Daily Self Reported Cocaine Use|A binary indicator of sustained abstinence, defined as three consecutive weeks of no cocaine use, obtained by self-report and verified using negative urine toxicology results, at any point of the trial;|reported weekly cocaine use for 12 weeks/ or study participation|All analyses were performed on an intent-to-treat basis|||participants|||Number
1289212|NCT00134784|Primary|Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images|The use of SPECT to measure striatal dopamine-transporter density with the use of [123I]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.|40 weeks|Per protocol|||percent change of B-CIT Uptake|Participants|Standard Deviation|Mean
1289213|NCT00134719|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.|From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age|Analysis was performed on the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the ourth dose vaccination phase.|||Participants|||Count of Participants
1289214|NCT00134719|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.|From enrolment through the day preceding the fourth dose|Analysis was performed on the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.|||Participants|||Count of Participants
1289215|NCT00134719|Secondary|Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine|Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.|During a 43-day (Day 0-42) after the fourth dose|Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.|||Participants|||Count of Participants
1289216|NCT00134719|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period|Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.|||Participants|||Count of Participants
1289217|NCT00134719|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.|During a 4-day period (Day 0-3) after the fourth dose vaccination phase|Analysis was performed on all subjects with an available symptom sheet in the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the fourth dose vaccination phase.|||Participants|||Count of Participants
1289218|NCT00134719|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.|During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase|Analysis was performed on all subjects with an available symptom sheet in the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.|||Participants|||Count of Participants
1289219|NCT00134719|Secondary|Anti-varicella Titers in Initially Seronegative Subjects|Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
1289527|NCT00129766|Primary|Number of Participants Reporting AEs by Highest Severity Grade|Adverse events events were graded by severity; Level 1, 2, 3, or 4|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
1289220|NCT00134719|Secondary|Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289221|NCT00134719|Secondary|Anti-mumps Titers in Initially Seronegative Subjects|Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
1289222|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289223|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination|ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.|42 days after the fourth dose|Analysis was performed on subjects with a pre-vaccination anti-mumps titer below 28 ED50 in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289224|NCT00134719|Secondary|Anti-rubella Concentrations in Initially Seronegative Subjects|Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||International Units per Milliliter||95% Confidence Interval|Geometric Mean
1289225|NCT00134719|Secondary|Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289226|NCT00134719|Secondary|Anti-measles Concentrations in Initially Seronegative Subjects|Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Milli-International Units per Milliliter||95% Confidence Interval|Geometric Mean
1289227|NCT00134719|Secondary|Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289228|NCT00134719|Secondary|Number of Subjects With a Fourth Dose Response for hSBA-MenY|Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.|42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289229|NCT00134719|Secondary|Number of Subjects With a Fourth Dose Response for hSBA-MenC|Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.|42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289230|NCT00134719|Secondary|Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5|The cut-off value assessed was a titer of 1:5.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point|||Participants|||Count of Participants
1289231|NCT00134719|Secondary|Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL|The cut-off value assessed was 4 IU/mL.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289232|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50|ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289233|NCT00134719|Secondary|Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL|The cut-off value assessed was 150 mIU/mL.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289234|NCT00134719|Secondary|Anti-PRP Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1289235|NCT00134719|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289236|NCT00134719|Secondary|Anti-PSY Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1289237|NCT00134719|Secondary|Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289238|NCT00134719|Secondary|Anti-PSC Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1289239|NCT00134719|Secondary|Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289240|NCT00134719|Secondary|hSBA-MenY Titers|The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
1289301|NCT00133952|Secondary|Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24|Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula >2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).|Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline macular edema measurements.|||Eyes|Participants||Number
1289241|NCT00134719|Secondary|Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values|The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289242|NCT00134719|Secondary|hSBA-MenC Titers|The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
1289243|NCT00134719|Secondary|Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values|The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289244|NCT00134719|Secondary|rSBA-MenY Titers|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
1289245|NCT00134719|Secondary|Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289246|NCT00134719|Secondary|rSBA-MenC Titers|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||titer||95% Confidence Interval|Geometric Mean
1289247|NCT00134719|Secondary|Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289248|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-varicella Antibodies|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.|||Participants|||Count of Participants
1289249|NCT00134719|Primary|Number of Subjects With an Anti-rubella Seroresponse|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.|||Participants|||Count of Participants
1289361|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
1289250|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-mumps Antibodies|"The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination.~ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent."|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.|||Participants|||Count of Participants
1289251|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-measles Antibodies|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.|||Participants|||Count of Participants
1289252|NCT00134719|Primary|Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128|The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.|One month after the 3-dose primary vaccination course|Analysis was performed on subjects in the MenHibrix and ActHIB + Meningitec groups only, on the Primary According-to-Protocol Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289253|NCT00134719|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)|The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.|One month after the 3-dose primary vaccination course|Analysis was performed on half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only, on the Primary According-to-Protocol (ATP) Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
1289254|NCT00134563|Secondary|Changes From Baseline in Fatigue Impact Scale [FIS] Total Score|"FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors)."|baseline (before randomization) and 108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||units on a scale||Standard Error|Least Squares Mean
1289255|NCT00134563|Other Pre-specified|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||mililiters (mL)||Standard Deviation|Mean
1289256|NCT00134563|Other Pre-specified|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, baseline EDSS stratum and baseline number of Gd-enhancing T1-lesions as covariates)."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||lesions per scan||95% Confidence Interval|Number
1289257|NCT00134563|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.|baseline (before randomization) and 108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||mililiters (mL)||Standard Deviation|Mean
1289258|NCT00134563|Secondary|Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints|"12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.~Probability of disability progression at 24, 48 and 108 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||percent probability||95% Confidence Interval|Number
1289259|NCT00134563|Primary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in EDSS score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||relapses per year||95% Confidence Interval|Number
1289260|NCT00134381|Secondary|Effect of 4-6% Caffeine on UVB-Induced Erythema|Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The erythema scores at 6, 8, and 24 hr post-UVB were averaged.|24 hr|Sixty-two (62) subjects received caffeine on one test site and placebo on the other site after exposure to 0.5-1.5 times individual subjects' minimal erythema dose (MED) of UVB.|||units on a scale||Standard Error|Mean
1289261|NCT00134381|Secondary|Effect of Green Tea Compounds on UVB-Induced Erythema|Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The mean scores at 48 hr were calculated.|48 hrs|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.|||units on a scale||Standard Error|Mean
1289262|NCT00134381|Primary|Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells|The percentage of phospho-p53 (Ser15) positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).|||percentage of p-p53 (Ser15) pos. cells||Standard Error|Mean
1289263|NCT00134381|Primary|Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells|The percentage of caspase-3-positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).|||percentage of caspase-3-positive cells||Standard Error|Mean
1289264|NCT00134381|Primary|"Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells"|"The percentage of apoptotic sunburn cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure."|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).|||"percentage of sunburn cells"||Standard Error|Mean
1289265|NCT00134381|Primary|"Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds"|"The mean change in number of apoptotic sunburn cells between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure."|48 hr|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.|||cells/mm||Standard Error|Mean
1289266|NCT00134381|Primary|Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds|The mean change in number of active caspase-3+ apoptotic keratinocytes between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.|48 hrs|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.|||cells/mm||Standard Error|Mean
1289267|NCT00134056|Other Pre-specified|Number of Patients With a Change in Functional Status|Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment.|up to 18 months study period||||Participants|||Count of Participants
1289508|NCT00129961|Secondary|Grade Distribution of NMSC Lesions|Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
1289268|NCT00134056|Other Pre-specified|Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)|"Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of 0 will be defined as stable if their WPS remains 0 for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment"|up to 18 months study period|There was a large amount of missing data points due to the difficulty of data collection of pain medication logs in addition to a questionnaire.The study team and site staff were only able to obtain complete data for the patients included in this analysis.|||Participants|||Count of Participants
1289269|NCT00134056|Secondary|Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria.|Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. PSA ≤ .2 ng/ml. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.|Up to 52 weeks|450 (225 in each arm) of 461 patients with measurable disease at trial enrollment were assessable for response by RECIST.|||Participants|||Count of Participants
1289270|NCT00134056|Secondary|Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.|PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression.|Up to 7 years after study opens||||Participants|||Count of Participants
1289271|NCT00134056|Secondary|Compare Qualitative and Quantitative Toxicity Between the Two Study Arms|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Assessed every 3 weeks up to 52 weeks|patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo|||Participants|||Number
1289272|NCT00134056|Secondary|Compare Pain Progression Between the Two Study Arms.|Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization.|Up to 52 weeks|Only those patients who progressed on study were included in this analysis. The proportion of patients with pain progression is calculated using number of patients with pain progression as the numerator and the total number of patients who progressed on study as the denominator.|||Participants|||Count of Participants
1289273|NCT00134056|Primary|Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.|Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression.|Up to 7 years after study opens||||months||95% Confidence Interval|Median
1289274|NCT00134056|Primary|Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.|Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact.|Up to 7 years after study opens||||months||95% Confidence Interval|Median
1289275|NCT00134043|Primary|Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Up to 3 years|Per RECIST (Response Evaluation Criteria in Solid Tumors)|||percentage of participants|||Number
1289276|NCT00134017|Secondary|Relapse|Percentage of participants who developed relapse or progressive disease.|2 years|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Relapse data was not collected on the remaining 25 participants.|||percentage of participants||95% Confidence Interval|Number
1289277|NCT00134017|Secondary|Non-relapse Mortality|Percentage of participants who died for BMT-related reasons.|Day 100, 2 years|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. NRM data was not collected on the remaining 25 participants.|||percentage of participants||95% Confidence Interval|Number
1289278|NCT00134017|Secondary|Chimerism|Number of patients who achieved 100% donor chimerism.|Day 30, Day 60|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Chimerism data was not collected on the remaining 25 participants. One participant died prior to Day 30 and was not analyzed for this outcome.|||Participants|||Count of Participants
1289279|NCT00134017|Secondary|Days to Engraftment|Median number of days to neutrophil and platelet engraftment.|Up to one year|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Engraftment data was not collected on the remaining 25 participants. Recipients of related-donor (n=78) and unrelated-donor (n=39) transplants were reported separately.|||days||Full Range|Median
1295935|NCT00075400|Other Pre-specified|AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC|Potential associations with clinical or PFS response will be assessed.|Baseline|||||||
1289280|NCT00134017|Primary|Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)|Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).|Day 100|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. GVHD data was collected on 15 additional participants for a total of 132. GVHD data was not collected on the remaining 10 participants.|||Participants|||Count of Participants
1289281|NCT00134004|Secondary|Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation|Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables.|1 year||||percentage of participants|||Number
1289282|NCT00134004|Secondary|Graft Failure Rate|Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as <5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure.|Cumulative incidence for the entire study, up to 11 years||||percentage of participants|||Number
1289283|NCT00134004|Primary|Progression-free Survival|Percentage of participants who do not experience disease relapse, disease progression, or death.|2 years||||percentage of participants|||Number
1289284|NCT00134004|Primary|Relapse Rate|Percentage of participants who experience disease relapse.|Cumulative incidence for the entire study, up to 11 years||||percentage of participants|||Number
1289285|NCT00134004|Primary|Transplant-related Mortality|Percentage of participants who die for any reason other than recurrence of disease.|Cumulative incidence for the entire study, up to 11 years||||percentage of participants|||Number
1289286|NCT00133991|Secondary|Relapse Pattern|Percentage of participants experiencing central nervous system (CNS) and systemic relapse.|Up to 6 months|The 4 participants who died during treatment were not analyzed for this outcome.|||Participants|||Count of Participants
1289287|NCT00133991|Primary|Percentage of Participants Experiencing Grade 3-5 Toxicity|Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria).|Up to 2 years||||Participants|||Count of Participants
1289288|NCT00133991|Primary|Event-free Survival|Percentage of participants alive without relapse at 1 year and 3 years.|1 year and 3 years||||percentage of participants||95% Confidence Interval|Number
1289289|NCT00133991|Primary|Overall Survival|Percentage of participants alive at 1 year and at 3 years.|1 year and 3 years||||percentage of participants||95% Confidence Interval|Number
1289290|NCT00133991|Primary|Overall Response Rate|Number of participants who have a complete or partial remission (2007 International Working Group criteria).|Up to 3 months|The 4 participants who died during treatment were not analyzed for this outcome.|||Participants|||Count of Participants
1289291|NCT00133978|Secondary|Hospital Length of Stay|Measure of the duration of the participant's hospital stay|6 months (from ICU admission)||||days||Inter-Quartile Range|Median
1289292|NCT00133978|Secondary|ICU Acquired Infection|We have made some modifications the definitions developed by the International Sepsis Forum Consensus Conference (CCM 2005;33:1538-1548) to operationalize the adjudication of infections in this trial. We grade the certainty of the diagnosis of infection using definitions for ‘Definite’, ‘Probable’, and ‘Possible’ for each category of infection. The categories of infection are: Deep surgical wound infection, Incisional (or superficial) surgical wound infection, Skin and soft-tissue infection (non-surgical) (SSTS), Catheter-related blood stream infections (CRI), Primary blood stream infections (BSI), Lower urinary tract infection, Upper urinary tract infection, Intra abdominal infection, Sinusitis, Lower respiratory tract infection (excluding pneumonia), ICU Acquired Pneumonia and Other.|Day 28||||participants|||Number
1289293|NCT00133978|Secondary|ICU Length of Stay|Measure of the duration of participant stay in the ICU|Day 28||||days||Inter-Quartile Range|Median
1289294|NCT00133978|Primary|28-day Mortality|28-day mortality/status: at 28 days after randomization;|Day 28||||participants|||Number
1289295|NCT00133952|Secondary|Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24|Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.|Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.|||participants|||Number
1289296|NCT00133952|Secondary|Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24||Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.|||participants|||Number
1289297|NCT00133952|Secondary|Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24||Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.|||participants|||Number
1289298|NCT00133952|Secondary|Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula||Baseline, up to 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements, last observation carried forward (LOCF).|||micrometer (µm)||Standard Deviation|Mean
1289299|NCT00133952|Secondary|Change From Baseline to Month 24 in Contrast Sensitivity|Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.|Baseline, 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline contrast sensitivity measurements.|||letters read correctly||Standard Error|Least Squares Mean
1289302|NCT00133952|Secondary|Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula|Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.|Baseline, 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements.|||micrometer (µm)||Standard Error|Least Squares Mean
1289303|NCT00133952|Primary|Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48|SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline through 48 months|All randomized participants who took at least 1 dose of study drug and had post-baseline SMVL measurements.|||percent of participants|||Number
1289304|NCT00133809|Secondary|The Number of Subjects Exhibiting Fasting C-peptide Levels ≥ 0.5 ng/mL|Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels at 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months after islet cell transplantation|1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation||||participants|||Number
1289305|NCT00133809|Secondary|Number of Subjects With HbA1C ≤ 6.5%|HbA1C was assessed in subjects 1, 3, 6, 9,12,18,24, 36, 48 and 60 months after transplantation and the number of subjects with values ≤ 6.5% was recorded which indicated better control of blood glucose levels.|1, 3, 6, 9,12,18,24, 36, 48 and 60 months post-transplantation||||participants|||Number
1289306|NCT00133809|Secondary|Number of Insulin-independent Subjects Following Islet Transplantation|Participants who did not need to take insulin at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months following islet transplantation|1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation||||participants|||Number
1289307|NCT00133809|Primary|The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation|Independence from insulin injections is measured by the actual use of insulin by the study participants.|one year after transplant||||participants|||Number
1289308|NCT00133705|Primary|Uterine Volume|Uterine volume is measured in mLs|6 months||||mL||Standard Deviation|Mean
1289309|NCT00133575|Secondary|Assessment of Dryvax Take Category|"Restricted to participants who received Dryvax 6-15 months after MVA. A take is a vesicle surrounded by a red areola which becomes umbilicated and then pustular before scabbing. Category 0=No take; Category 1=Significant modified take skin reaction; Category 2=Modified take skin reaction; Category 3=Primary take skin reaction"|3 weeks after Dryvax challenge||||Participants|||Number
1289310|NCT00133575|Secondary|Peak Titer of Viral Shedding Post Dryvax Challenge|Median Dryvax virus titers as assessed from swabs of the vaccination site lesion taken at intervals until the vaccination site is scabbed. The maximum titer recovered during the sampling period for each participant is utilized in determining the median for the group.|Until vaccination site lesion has scabbed||||Titers||Full Range|Median
1289311|NCT00133575|Secondary|Peak T-cell Gamma Interferon Responses (ELISPOT)|Median T-cell gamma interferon responses against the vaccinia virus as the assay antigen, as assessed by ELISPOT from sera collected 2 weeks after receipt of 2 doses. Responses are expressed as the number of spot forming units per 10^6 peripheral blood mononuclear cells (SFU/10^6 PBMC).|Approximately Day 42 after first vaccination||||SFU/10^6 PBMC||Inter-Quartile Range|Median
1289312|NCT00133575|Secondary|Peak Binding Antibodies (ELISA) to Vaccinia|Median binding antibody titers against vaccinia virus as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination||||Titers||Inter-Quartile Range|Median
1289313|NCT00133575|Secondary|Peak Binding Antibodies (ELISA) to ACAM3000 MVA|Median binding antibody titers against ACAM3000 MVA as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination||||Titers||Inter-Quartile Range|Median
1289314|NCT00133575|Secondary|Peak Neutralizing Antibodies to Vaccinia|Median neutralizing antibody titers against vaccinia virus as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination||||Titers||Inter-Quartile Range|Median
1289315|NCT00133575|Secondary|Peak Neutralizing Antibodies to ACAM3000 MVA|Median neutralizing antibody titers against ACAM3000 MVA as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination||||Titers||Inter-Quartile Range|Median
1289316|NCT00133575|Primary|Number of Participants With Signs of Possible Myopericarditis|Number of participants with signs of possible myopericarditis, either by clinical or laboratory (EKG, troponin) evaluation, at any time after vaccination for the during of the study|Within 360 days after vaccination||||Participants|||Number
1289317|NCT00133575|Primary|Number of Participants With Urinalysis Laboratory Abnormalies After Vaccination|Number of participants with urinalysis laboratory abnormalies after vaccination, including proteinuria and hematuria by dipstick. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination||||Participants|||Number
1289318|NCT00133575|Primary|Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination|Number of participants with enzymatic clinical laboratory abnormalities after vaccination, including AST, ALT and alkaline phosphatase. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions|28 days after vaccination||||Participants|||Number
1289319|NCT00133575|Primary|Number of Participants With Clinical Chemistry Laboratory Abnormalities After Vaccination|Number of participants with clinical chemistry laboratory abnormalities after vaccination, including total bilirubin and serum creatinine. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination||||Participants|||Number
1289320|NCT00133575|Primary|Number of Participants With Hematologic Laboratory Abnormalities After Vaccination|Number of participants with hematologic laboratory abnormalities after vaccination, including hemoglobin, white blood cell count, neutrophil count and platelet count. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination||||Participants|||Number
1289321|NCT00133575|Primary|Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions|Number of participants reporting moderate or greater systemic reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.|15 days after vaccination||||Participants|||Number
1289322|NCT00133575|Primary|Number of Participants Reporting Moderate or Greater Solicited Local Reactions|Number of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.|15 days after vaccination||||Participants|||Number
1289323|NCT00132873|Primary|Vital Signs|Average Respiratory Rate at 1 year.|At 1 year||||Breaths per minute||Standard Deviation|Mean
1289324|NCT00132873|Primary|Adverse Experiences|Number of Subjects with treatment-emergent adverse events.|continuous||||participants|||Number
1289325|NCT00132808|Secondary|Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum|Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.|||ng/mL||Standard Deviation|Mean
1289326|NCT00132808|Secondary|Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum|Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.|||ng/mL||Standard Deviation|Mean
1289327|NCT00132808|Secondary|Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum|Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.|||ng/mL||Standard Deviation|Mean
1289328|NCT00132808|Secondary|Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.|The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline).|Baseline, Month 24|Intent to treat population with available data.|||Percentage change in BMD||Standard Error|Least Squares Mean
1289329|NCT00132808|Secondary|Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.|The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline).|Baseline, Month 24|Intent to treat population with available data.|||Percentage change in BMD||Standard Error|Least Squares Mean
1289330|NCT00132808|Primary|Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum|The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month – lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).|Baseline, Month 24|Intent to treat population. Last observation carried forward (LOCF) was utilized to impute missing data.|||Percentage change in BMD||Standard Error|Least Squares Mean
1289331|NCT00132769|Secondary|Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein|C-reactive protein levels rise in response to inflammation in the body. The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect. On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12. A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.|Baseline and the average of Treatment Weeks 8, 10 and 12|The APT population consisted of all participants with a baseline and at least one postbaseline observation.|||ratio||95% Confidence Interval|Least Squares Mean
1289332|NCT00132769|Secondary|Patient's Assessment of Pain|"At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from No pain (0) to Extreme pain (100). A lower score indicates less pain."|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
1289333|NCT00132769|Secondary|Health Assessment Questionnaire Disability Index|The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Responses range from 0=No disability to 3=Completely disabled. The score for each category subscale is the single response within the category with the highest score (greatest difficulty). The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.|The average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
1289334|NCT00132769|Secondary|Patient Global Assessment of Response to Therapy|Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4). A higher score indicates a more positive response to study drug.|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
1289335|NCT00132769|Secondary|Investigator Global Assessment of Disease Activity|At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5). A lower score indicates a more positive assessment of participant disease activity.|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
1289336|NCT00132769|Secondary|Patient Global Assessment of Disease Activity|"At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: “Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing.” The VAS ranges from Very Well (0) to Very Poor (100). The mean score at Treatment Weeks 8, 10 and 12 was calculated. A lower score indicates a better disease activity."|The average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
1295936|NCT00075400|Other Pre-specified|PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC|Potential associations with clinical or PFS response will be assessed.|Baseline|||||||
1289337|NCT00132769|Secondary|Change From Baseline in Tender Joint Count|Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws. The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC. TJC ranges from 1-68, with increasing score indicating greater number of tender joints. TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean TJC - Baseline TJC.|Baseline and the average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
1289338|NCT00132769|Secondary|Percentage of Participants With American College of Rheumatology 20% Response [ACR20]|Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]). The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.|Baseline and the average of Treatment Weeks 8, 10 and 12|The APT population consisted of all participants with a baseline and at least one postbaseline observation.|||percentage of participants|||Number
1289339|NCT00132769|Primary|Change From Baseline in Swollen Joint Count|Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.|Baseline and the average of Treatment Weeks 8, 10 and 12|The All Patients Treated (APT) population consisted of all participants with a baseline and at least one postbaseline observation.|||score on a scale||95% Confidence Interval|Least Squares Mean
1289340|NCT00132730|Secondary|Change From Baseline in Predose (Trough) Forced Vital Capacity (FVC)|FVC is a measure, in liters and using a spirometer, of the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. The values averaged during the placebo run-in period were used for the baseline measurement and the values averaged over Treatment Weeks 8, 10 and 12 were used for the on-treatment measurement. A higher value indicates greater lung exiratory function.|Predose at Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||liters||95% Confidence Interval|Least Squares Mean
1289341|NCT00132730|Secondary|Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|COPD exacerbation is defined as any change in symptoms or functional status that leads to administration (at investigator's discretion) of systemic corticosteroids (above participant's usual dose) and/or antibiotics, or an unscheduled COPD-related hospitalization, emergency room visit, or doctor visit. The number of participants who experienced at least one COPD exacerbation during the 12-week treatment period is reported.|Baseline through Treatment Week 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||participants|||Number
1289342|NCT00132730|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) Response|The SOBQ is a validated 24-item measure of dyspnea associated with activities of daily living in patients with moderate to severe chronic lung disease. Twenty-one items ask patients about how frequently they experience shortness of breath (SOB) on a 6-point scale of 0 (never) to 5 (activity given up due to dyspnea) when performing various tasks. Three additional questions about limitations due to SOB, fear of harm from overexertion and fear of SOB are included for a total of 24 items. If patients do not routinely perform the activity indicated in the questionnaire, they are asked to estimate the degree of SOB anticipated. The SOBQ total score is calculated by summing responses across all 24 items. The total score ranges from 0 to 120, with a higher score indicating greater frequency of and limitations due to SOB. The score assessed at the baseline visit was used for the baseline score and the mean score assessed at Treatment Weeks 8 and 12 was used as the on-treatment score.|Baseline and Treatment Weeks 8 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||score on a scale||95% Confidence Interval|Least Squares Mean
1289343|NCT00132730|Secondary|Transition Dyspnea Index (TDI) Focal Score|The baseline dyspnea index (BDI) was measured at the randomization visit as a 3-domain score with a scale of 0 to 4 in each domain, with a total focal score of 12 indicating no dyspnea limitation and 0 indicating severe dyspnea. After 12 weeks of treatment, the investigator-administered TDI was completed, with a change in each of the 3 domains being rated from -3 (major deterioration) to +3 (major improvement), so that the TDI focal score could range from -9 to +9. A higher TDI focal score indicates improvement.|Baseline and Treatment Week 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||score on a scale||95% Confidence Interval|Least Squares Mean
1289344|NCT00132730|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Response|"The SGRQ consists of 76 items in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impacts (social functioning, psychological disturbances resulting from airways disease). Scores for each domain and a total score are calculated; each questionnaire response has a unique empirically dervied weight. Scores range from 0 to 100, with higher scores indicating poor health. Each domain of the questionnaire is scored separately in 2 steps: 1) The weights for all items with a positive response are summed; 2) The score is calculated by dividing the summed weights by the maximum possible weight for that domain and expressing the results as a percentage. The mean SGRQ scores were calculated during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment."|Baseline and Treatment Weeks 8 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||score on a scale||95% Confidence Interval|Least Squares Mean
1296441|NCT00068718|Secondary|Incidence of Grade II-IV GVHD in Patients Undergoing DLI Following a Non-myeloablative Transplant|Percentage of Participants with II-IV Acute GVHD|100 days after DLI||||percentage of participants|||Number
1289345|NCT00132730|Secondary|Change From Baseline in Total Daily Beta-agonist Use|The total daily beta-agonist use was measured in puffs per day and was recorded on daily diary cards by participants. It is defined as the sum of beta-agonist use between when participants arose from and went to bed. The total daily beta-agonist use values were the recorded mean during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment.|Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||Puffs per day of beta-agonist||95% Confidence Interval|Least Squares Mean
1289346|NCT00132730|Secondary|Change From Baseline in Overall Daytime Symptoms Score|"On a daily diary card, participants rated their responses to the question Overall, how much of the time did you have symptoms from your lung disease today? (0=none of the time; 5=all of the time). Scores range from 0 to 5, with higher scores indicating more time with symptoms. The overall daytime symptoms score value was the mean daily diary score during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment."|Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||score on a scale||95% Confidence Interval|Least Squares Mean
1289347|NCT00132730|Primary|Change From Baseline in Pre-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is a measure, in liters, of the amount of air expired in 1 second. Measured values were averaged during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment. For participants who did not have any measurements over the last 4 weeks of the 12-week treatment period, the last available on-treatment measurement was carried forward.|Pre-dose at Baseline and Treatment Weeks 8, 10 and 12|The modified intention-to-treat (ITT) population includes all participants who had a baseline and at least one posttreatment measurement.|||liters||95% Confidence Interval|Least Squares Mean
1289348|NCT00132691|Secondary|Mortality||24 months||||percentage of participants||95% Confidence Interval|Number
1289349|NCT00132691|Secondary|Diabetes Mellitus||24 months|Participants with prevalent complications or missing data at enrollment were excluded from the risk set.|||percentage of participants||95% Confidence Interval|Number
1289350|NCT00132691|Secondary|Hypertension Diagnosis Requiring Treatment||24 months|Participants with prevalent complications or missing data at enrollment were excluded from the risk set.|||percentage of participants||95% Confidence Interval|Number
1289351|NCT00132691|Secondary|Hyperlipidemia - Incident|LDL greater than or equal to 160 mg/mL|24 months|Number of participants at risk were included in the analysis|||percentage of participants at risk||95% Confidence Interval|Number
1289352|NCT00132691|Secondary|Change in SF-36 Physical Component Score From Baseline to 24 Months|Self-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful.|24 months||||units on a scale||Standard Error|Mean
1289353|NCT00132691|Secondary|Change in SF-36 Mental Component Score From Baseline to 24 Months|Self-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group.|24 months||||units on a scale||Standard Error|Mean
1289354|NCT00132691|Secondary|Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months|The NEI-VFQ 25 measures the effect of visual disability/symptoms with generic health and task-oriented domains. The range for the composite score is 0 to 100; higher scores are associated with better visual function. A change of 4 to 6 points is considered to be a clinically meaningful difference.|24 months||||units on a scale (composite score)||Standard Error|Mean
1289355|NCT00132691|Secondary|Cataract - Incident Cataract||24 months|Eyes with uveitis, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
1289356|NCT00132691|Secondary|Intraocular Pressure - IOP-lowering Surgery||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
1289357|NCT00132691|Secondary|Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.|The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported.|24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
1289358|NCT00132691|Secondary|Glaucoma - Incident|Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.|24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
1289359|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
1289360|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
1289362|NCT00132691|Secondary|Uveitis Activity|Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess.|24 months|All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy).|||percentage of eyes with uveitis|Participants|95% Confidence Interval|Number
1289363|NCT00132691|Secondary|Macular Edema|center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center|24 months|All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy)..|||percentage of eyes with uveitis|Participants|95% Confidence Interval|Number
1289364|NCT00132691|Primary|Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis|Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.|24 months|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 255 randomized participants were used in the analytic model. 232 of the 255 completed the 2 year outcome visit."|||letters||Standard Error|Mean
1289365|NCT00132678|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS)|Measure of depression; score range 0 to 60 (lower score = less severity)|Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV|Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient’s last nonmissing, postbaseline value in Period IV (last observation carried forward technique)|||units on a scale||Standard Deviation|Mean
1289366|NCT00132678|Secondary|Change in Young Mania Rating Scale (YMRS) Scores.|Measure of mania; score range 0 to 60 (lower score = less severity)|Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV|Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient’s last nonmissing, postbaseline value in Period IV (last observation carried forward technique)|||units on a scale||Standard Deviation|Mean
1289367|NCT00132678|Primary|Number of Participants Who Had a Mood Relapse.|"Mood Relapse was defined as:~The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score >12 or a CGI-S score >4; or a dose increase, or supplementation with oral risperidone or another antipsychotic or mood stabilizer, was needed in the opinion of the investigator."|24 months|Intention to treat. 28 subjects from a Good Clinical Practice noncompliant site and 1 site with alleged research misconduct were excluded from efficacy analyses. The median (interquartile range) for time to relapse (d): Risperdal Consta: NA (173, NA) & Placebo: 219 (82, NA) [NA = not available; Risperdal Consta relapse percent < 50% & Placebo <75%]|||Participants|||Number
1289368|NCT00132496|Primary|Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group|Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.|8 weeks from randomization and end of treatment|Safety population (all patients who received at least one dose of study treatment) was the primary analysis population.|||Participants|||Number
1289369|NCT00132314|Primary|Hazard Ratio for Hospitalization|Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.|24 months||||participants|||Number
1289370|NCT00132314|Primary|Hospitalization-free Survival - Time to Event|A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.|From randomization until date of first re-hospitalization, assessed up to 24 months||||years||95% Confidence Interval|Median
1289371|NCT00132301|Primary|Number of Participants With Progression-Free Survival|The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy.|Up to 100 months (centralized follow-up)|One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.|||Participants|||Count of Participants
1289372|NCT00132132|Primary|Percentage of Participants With BMI Reduction||Baseline, 12-15 months|Per protocol|||percentage of participants|||Number
1289373|NCT00132132|Primary|Change in BMI (Body Mass Index)||Baseline, 12-15 months|Per protocol analysis: subjects who attended at least one intervention session in addition to their final assessment|||kg/m^2||95% Confidence Interval|Mean
1289374|NCT00132028|Secondary|Overall Survival|Measured from date of registration to death, or last contact date|after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.|All eligible patients who started treatment were included in assessing overall survival.|||months||95% Confidence Interval|Median
1289375|NCT00132028|Secondary|Progression-Free Survival|Measured from date of registration to date of first observation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.|after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.|All eligible patients who started treatment were included in assessing progression-free survival.|||months||95% Confidence Interval|Median
1289376|NCT00132028|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|after every 3 cycles on treatment|All patients who started treatment were included in assessing response estimates.|||participants|||Number
1289377|NCT00132002|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment to the time of documented progression, assessed up to 5 years||||Months||95% Confidence Interval|Median
1289378|NCT00132002|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From the initial date of treatment to time of death, up to 5 years.||||Months||95% Confidence Interval|Median
1289379|NCT00132002|Primary|Objective Tumor Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 8 weeks||||percentage of participants|||Number
1289380|NCT00131937|Secondary|Overall Survival|Overall survival is defined as the time from study entry until death from any cause.|Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.||||months||90% Confidence Interval|Median
1289381|NCT00131937|Secondary|Progression-Free Survival (PFS)|"PFS is defined as the time from randomization to the first of progression, relapse or death from any cause. Per criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999), progression (for patients who have not responded) and relapse (for patients who responded) are defined as:~Appearances of any new lesions/sites during or after therapy~Increase of ≥50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver/spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site~Increase by ≥50% in greatest diameter from nadir measurement of any previously involved dominant node >1.0 cm in its short axis"|Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years||||months||90% Confidence Interval|Median
1289382|NCT00131937|Primary|Overall Response (OR) Rate|"Response was assessed using the criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999). OR=complete response(CR)+complete response/uncertain(CRu)+partial response(PR) CR: 1)Disappearance of clinical/radiographic evidence of disease (dz) and all dz-related B-symptoms; normalization of biochemical abnormalities attributed to NHL; 2)Lymph nodes and nodal masses regress to normal size; 3)Spleen, if enlarged before therapy, has decreased in size and is not palpable; 4)Complete resolution of lymphoma in bone marrow biopsy CRu: Meet criteria 1 and 3 above but with ≥1 of the followings. Residual dominant nodal mass >1.5 cm in greatest diameter that has decreased by >75%. Indeterminate bone marrow.~PR: ≥50% decrease in SPD (sum of products of diameters) of 6 largest dominant nodes or nodal masses. No increase in size of liver or spleen. No unequivocal progression in nonmeasurable or nondominant sites. Splenic/hepatic nodules regress ≥50% in SPD. No new dz sites."|Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.||||Proportion of participants||90% Confidence Interval|Number
1289383|NCT00131911|Secondary|Duration of Response|Duration of response (DOR) was defined as the time from attaining a response (PR or CR) to the date of progression. Participants without progression were censored at the date of their most recent disease assessment. The median DOR was estimated using simple summary statistics.|Time from response to progression (up to 2 years)|There were 4 confirmed responses in Group A and 5 confirmed responses in Group B used in analyzing this endpoint.|||months||Full Range|Median
1289384|NCT00131911|Secondary|Progression Free Survival|Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST) as a 20% increase in the su of longest diameter of target lesions. Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Participants who were progression free were censored at the date of their most recent disease assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to progression or death (up to 2 years)||||months||95% Confidence Interval|Median
1289385|NCT00131911|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|From registration to death (up to 2 years)||||months||95% Confidence Interval|Median
1289386|NCT00131911|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of participants reporting a grade 3 or higher toxicity are reported.|Up to 2 years||||participants|||Number
1289399|NCT00131677|Primary|Clinical Safety--Creatinine Elevations|Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)|24 months (immediate arm) and 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined. Participants entered the TE cohort with first dispense and exited with the first occurrence of: (1) completion of follow-up, (2) 30 days after permanent drug interruption, or (3) 30 days after last visit. For delayed arm participants,time before initiation of drug was excluded.|||Participants|||Number
1289524|NCT00129766|Primary|Number of Participants Reporting Changes in Vital Signs From Baseline|Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
1289387|NCT00131911|Primary|Confirmed Response Rate|"Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. > > Complete Response (CR) is defined as the disappearance of all target lesions. > Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions; >~> We report the percentage of patients with a confirmed response and a 95% confidence interval estimated by the Duffy and Santner method."|Duration of Treatment (Up to 2 years)|Nine of the 50 carcinoid patients and 6 of the 42 Islet cell patients did not continue treatment past cycle 1. Therefore, these patients were not evaluated on consecutive cycles and were excluded from this endpoint.|||percentage of participants||95% Confidence Interval|Number
1289388|NCT00131885|Secondary|Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)||||IU/mL||Standard Deviation|Mean
1289389|NCT00131885|Secondary|Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)||||pg/mL||Standard Deviation|Mean
1289390|NCT00131885|Primary|Clearance (L/hr) of Levonorgestrel Over 24 Hours for Each Dosage Group and Each Study Session.|Average and standard deviation for Clearance (L/hr) of Levonorgestrel study for each dosage group and each study session.|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)||||L/hr||Standard Deviation|Mean
1289391|NCT00131885|Secondary|Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)||||IU/mL||Standard Deviation|Mean
1289392|NCT00131885|Primary|Number of Participants With Progesterone Levels Above 3.0 ng/ml at Time 1 (Baseline) and Time 2 (After Intervention With St John's Wort or Placebo).|"Serum progesterone levels were drawn at the time of dosing with levonorgestrel and then at weekly intervals until menses occurred. This was done at Time 1 (baseline), and again at Time 2 (after 5 weeks of dosing with St. John's Wort or placebo).~Possible ovulation was defined as a serum progesterone >3ng/ml within 2 weeks of Days 9-12 of the menstrual cycle."|Progesterone levels drawn at weekly intervals after dosing with levonorgestrel between Days 9 and 12 of the menstrual cycle, at each time point until menses||||Participants|||Number
1289393|NCT00131885|Primary|Area Under the Concentration Versus Time Curve for 0 to 24 Hours After Drug Administration, Done Between Days 9 and 12 of the Menstrual Cycle at Time 1 (Before) and Time 2 (During Treatment With St. John's Wort or Placebo)|"Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Serum samples drawn at 0, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, and 24 hours, following oral administration of a dose of levonorgestrel.~Treatment between the two time periods was with St. John's Wort or placebo herb, beginning after the Time 1 (baseline) and continued for 5 weeks until Time 2.~Estimates of levonorgestrel clearance were made using a two stage non-compartmental approach to determine individual and group parameters."|Area Under the Concentration versus Time curve for 0 to 24 hours after drug administration, between Days 9 and 12 of the menstrual cycle, done at Time 1 and at Time 2||||ng*hr/mL||Standard Deviation|Mean
1289394|NCT00131677|Other Pre-specified|>5% Bone Mineral Density Decline at Femoral Neck|Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck.|24 months (immediate arm), 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug. In addition, this analysis population includes only those participants for whom bone density analyses were performed.|||percentage of participants|||Number
1289395|NCT00131677|Primary|Clinical Safety--Hypophosphatemia|Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)|24 months (immediate arm), 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.|||participants|||Number
1289396|NCT00131677|Secondary|Behavioral Safety--Unprotected Anal Sex (UAS)|Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study.|Nine months||||percentage of ppts reporting UAS|||Number
1289397|NCT00131677|Secondary|Adherence to Study Drug|Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps.|24 months (immediate arm) and 15 months (delayed arm)||||percentage of doses|||Number
1289398|NCT00131677|Secondary|Number of Breakthrough HIV Infections|Number of participants with HIV seroconversions occuring while on study drug|24 months (immediate arm) and 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.|||participants|||Number
1289488|NCT00130117|Secondary|Bone Markers - Ctx and Sclerostin||36 weeks|Only for subjects participating in both phase A and phase B (n=4), bone markers were assessed to see the change over 24 month period. All these patient got metreleptin treatment|||ng/mL||Inter-Quartile Range|Median
1289400|NCT00131664|Secondary|Mean Change From Baseline in Adiponectin at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||µg/mL||Standard Error|Mean
1289401|NCT00131664|Secondary|Mean Change From Baseline in Adiponectin at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||microgram per millilitre (µg/mL)||Standard Error|Mean
1289402|NCT00131664|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. CRP was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||mg/dL||Standard Deviation|Mean
1289403|NCT00131664|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. CRP was only done at baseline, months 6 and 8. The test was optional and performed only by participating sites.|Baseline and Month 6|All Primary and secondary endpoints were calculated on the Intent to Treat (ITT) population where each patient had at least one dose of the medication and at least one valid observation. Missing values were carried forward (using Last Observation Carried Forward method) except for the calculation of the composite variables.|||milligram per decilitre (mg/dL)||Standard Error|Mean
1289404|NCT00131664|Secondary|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12|"Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2. The UKPDS (U.K. Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to HDL ratio at a specified visit.~The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event."|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||percent||Standard Error|Mean
1289405|NCT00131664|Secondary|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6|"Change from baseline was calculated as the Month 6 value minus the baseline value, with LOCF from Month 2. The UKPDS (United Kingdom Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to high-density lipoprotein (HDL) ratio at a specified visit.~The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event."|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||percent||Standard Error|Mean
1289406|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 12|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 12 with LOCF from Month 2.|Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||participants|||Number
1289407|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 6|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 6 with LOCF from Month 2.|Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||participants|||Number
1289408|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 4|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 4 with LOCF from Month 2.|Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.|||participants|||Number
1289409|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2 for withdrawn subjects or missing values.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||millimoles per litre (mmol/L)||Standard Error|Mean
1289489|NCT00130117|Primary|the Difference Between the Placebo and Leptin Treated Groups in the Change in Bone Mineral Content(BMC) at the Anteroposterior (AP) Spine From Baseline to 36 Weeks||36 weeks||||g||Full Range|Mean
1289410|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||millimoles per litre (mmol/L)||Standard Error|Mean
1289411|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4|Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.|||millimoles per litre (mmol/L)||Standard Error|Mean
1289412|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 12|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 12 with LOCF from Month 2.|Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||participants|||Number
1289413|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 6|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 6, with LOCF from Month 2.|Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline Month 6 were analyzed.|||participants|||Number
1289414|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 4|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 4, with LOCF from Month 2.|Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.|||participants|||Number
1289415|NCT00131664|Secondary|Mean Change From Baseline in A1C at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||percent||Standard Error|Mean
1289416|NCT00131664|Secondary|Mean Change From Baseline in A1C at Month 4|Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.|||percent||Standard Error|Mean
1289417|NCT00131664|Primary|Mean Change From Baseline in A1C at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with a value at baseline and at Month 6 were analyzed.|||percent||Standard Error|Mean
1289418|NCT00131573|Primary|Freedom From Major Complications||5 years||||Number of Adverse Events|||Number
1289419|NCT00131573|Primary|Average Number of Voids Per Day||12 months||||Average Number of Voids||Standard Deviation|Median
1289420|NCT00131508|Secondary|Change in Hand Grip From Baseline to 12 Months.|"To investigate the clinical effects of oral glutamine and placebo on hand grip in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.~Hand grip strength is a measure of muscle strength.Units are measured in Kg.Muscle strength is measured using a hydraulic hand-held dynamometer.Change was defined as 12 Month measure minus baseline.Muscle strength is measured using the hand grip strength via a hydraulic hand-held dynamometer (Kg)."|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||kg||Full Range|Median
1289421|NCT00131508|Secondary|Change in Pulse Rate From Baseline to 12 Months|To investigate the clinical effects of oral glutamine and placebo on pulse rate in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||Beats per minute (BPM)||Full Range|Median
1289422|NCT00131508|Secondary|Change in Weight Percentile From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on weight in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Basline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||Percentile||Full Range|Median
1289423|NCT00131508|Secondary|Change in Height Percentile From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on height percentile in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||Percentile||Full Range|Median
1289424|NCT00131508|Secondary|Change in Height Z-score From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on height Z-score in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||Z-score||Full Range|Median
1289425|NCT00131508|Secondary|Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports.|Evaluation of quality of life at baseline and 12 months in the glutamine versus placebo group using the PedsQL Version 4.0 inventory. This instrument measures individual well being across physical, emotional, social, and school function categories using patient self-reports and/or parent reports. The tool contains a 15-question, age-specific, self-report inventory (for children age 5-7 years, 8-12 years, and 13-18 years) and a corresponding parent inventory. Lower scores indicate a better quality of life.|Baseline and 12 Months||||Units on a scale||Full Range|Median
1289426|NCT00131508|Secondary|Change in Red Blood Cell Glutamine From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo in children with Sickle Cell Anemia (SCA) by comparing the difference in the levels of red blood cell glutamine between baseline and 12 months of treatment in the two groups.|Baseline and 12 months||||nmol/mg creatinine||Full Range|Median
1289427|NCT00131508|Secondary|Change in Body Mass Index From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes (BMI) between baseline and 12 months of treatment in the two groups.|Baseline and 12 months||||kg/m2||Full Range|Median
1289428|NCT00131508|Primary|Change in Resting Energy Expenditure From Baseline to 12 Months|To compare the effect of glutamine and placebo on resting energy expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in REE ratio between baseline and 12 months. REE was measured by indirect calorimetry, using a metabolic cart.REE Ratio =(REE Measured/REE Predicted)x 100).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.The REE Ratio was evaluated at baseline and 12 months.The REE Ratio is calculated as (REE Measured / REE Predicted) x 100).REE units are measured as (Kcal / day).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.|Baseline and 12 months||||REE ratio||Full Range|Median
1289429|NCT00131456|Primary|Two Consecutive Weeks of Marijuana Abstinence|The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.|measured daily by self report for 12 weeks of the trial or length of study participation|All analyses were conducted based on the intent-to-treat principle.|||participants|||Number
1289430|NCT00131378|Primary|Abdominal Fat|6 month change in visceral abdominal fat (primary body composition endpoint)|Measured at baseline and month 6||||cm^2||Standard Error|Mean
1289431|NCT00131378|Primary|Total Abdominal Fat|6 month change in total abdominal fat (primary body composition endpoint)|Measured at baseline and month 6||||cm^2||Standard Error|Mean
1289432|NCT00131378|Secondary|Insulin-like Growth Factor-1 (IGF-1) Levels|6-month change in IGF-1 levels|Measured at baseline and month 6||||ng/mL||Standard Error|Mean
1289433|NCT00131378|Secondary|Measure of Insulin Resistance|6 month change in 2-hour glucose (primary insulin resistance endpoint)|Measured at baseline and month 6||||mg/dL||Standard Error|Mean
1289434|NCT00131378|Primary|HsCRP|6 month change in HsCRP (primary cardiovascular risk endpoint)|Measured at baseline and month 6|ITT|||mg/L||Standard Error|Mean
1289435|NCT00131352|Secondary|Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26|"Participants were classified as a positive responder if at least one of the following two conditions were met:~A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR~Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU"|Week 26|Intent-To-Treat (ITT) population.|||participants|||Number
1289436|NCT00131352|Secondary|Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26|The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.|Week 26|Intent-To-Treat (ITT) population|||participants|||Number
1289437|NCT00131352|Secondary|Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26|The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.|Week 26|Intent-To-Treat (ITT) population|||participants|||Number
1289438|NCT00131352|Secondary|Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale|The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0–4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.|Day 0, Week 26|Intent-To-Treat (ITT) population.|||units on a scale||Standard Error|Mean
1289439|NCT00131352|Secondary|Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale|The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0–4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.|Day 0, up to week 26|Intent-To-Treat (ITT) population.|||units on a scale||Standard Error|Mean
1289507|NCT00129961|Secondary|Number of Recurrent NMSC Lesions Per Subject-year|Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||lesions per participant year|||Number
1289440|NCT00131352|Secondary|Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale|Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.|Week 26|Intent-To-Treat (ITT) population|||participants|||Number
1289441|NCT00131352|Secondary|Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale|The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0–4, where 0=no pain and 4=extreme pain.|Day 0, Week 26|Intent-To-Treat (ITT) population.|||units on a scale||Standard Error|Mean
1289442|NCT00131352|Primary|Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale|The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0–4, where 0=no pain and 4=extreme pain.|Day 0, up to week 26|Intent-To-Treat (ITT) population which included all participants randomized to study treatment on Day 0.|||units on a scale||Standard Error|Mean
1289443|NCT00131248|Primary|Bradycardia Episodes/Day||7 days|18 participants originally enrolled, 1 withdrew, leaving 17 participants analyzed.|||episodes per day||Standard Deviation|Mean
1289444|NCT00130923|Secondary|Clinical Symptoms, Global Functioning, Cognition, and Extrapyramidal System Effects||6 months|||||||
1289445|NCT00130923|Secondary|Other Substance Use as Assessed by the Timeline Followback Scale||6 months|||||||
1289446|NCT00130923|Primary|Mean Heavy Drinking Days Per Week||6 months||||Drinking days per week||Standard Deviation|Mean
1289447|NCT00130832|Primary|Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered|Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.|Approximately 42 days Postdose 3|"Per Protocol Population~For serotype G4 the RotaTeq and Oral Poliovirus (OPV) concomitantly group N = 350"|||GMT||95% Confidence Interval|Geometric Mean
1289448|NCT00130832|Primary|GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)|GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered|Approximately 42 days Postdose 3|Per Protocol Population|||GMT||95% Confidence Interval|Geometric Mean
1289449|NCT00130832|Primary|Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3|GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.|Approximately 42 days Postdose 3|The primary immunogenicity analyses were based on evaluable per-protocol subjects who received all scheduled doses, were not protocol violators, and had valid assay values.|||Geometric Mean Titer (GMT)||95% Confidence Interval|Geometric Mean
1289450|NCT00130793|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination|GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination|From prevaccination (baseline) to 4 weeks postvaccination|The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1289451|NCT00130793|Secondary|Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination|Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|4 weeks|All vaccinated subjects with safety follow-up are included.|||Participants|||Number
1289452|NCT00130793|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.|4 weeks|The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1289453|NCT00130780|Primary|The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment.|These criteria have been modified for the purpose of this study (i.e.: there will be no confirmation of response at 4 weeks per usual response criteria as this is not applicable to the preoperative treatment plan): Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the meas|2 years||||participants|||Number
1289454|NCT00130728|Secondary|Duration of Objective Response|Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.|Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)|Patients with an objective response|||months||95% Confidence Interval|Median
1289455|NCT00130728|Secondary|Percentage of Participants With Objective Response|Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.|The median duration of Objective response was up to 9.7 months|Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder.|||Percentage of participants||95% Confidence Interval|Number
1289456|NCT00130728|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.|From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)|Randomized patients|||months||95% Confidence Interval|Median
1289457|NCT00130728|Primary|Overall Survival (OS) Among All Randomized Patients|Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.|From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)|Randomized patients|||months||95% Confidence Interval|Median
1289458|NCT00130689|Primary|Overall Response Rate|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 weeks (range 1-23 weeks).|Responses were determined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|||proportion of paticipants||90% Confidence Interval|Number
1289459|NCT00130637|Primary|Number of Participants Reporting a Serious Adverse Event (SAE)|Safety of acute daclizumab use in JIA-associated uveitis was assessed through serious adverse events (SAE).|52 weeks||||participant|||Number
1289460|NCT00130637|Primary|Number of Participants With a Two-step Reduction in Inflammation|Number of participants with a two-step reduction (or down to 0 out of a scale of 0 to 4+) of anterior chamber (AC) inflammation according to Standardization of Uveitis Nomenclature (SUN) criteria, while on a topical corticosteroid schedule of less than 3 times a day. Grade 0 is the best score on this scale with <1 cell in the field and 4+ is the worst score on this scale with >50 cells in the field.|12 weeks||||participants|||Number
1289461|NCT00130520|Primary|Median Response Duration (Weeks)|Response duration=time (in weeks) between date of measurable response and date of progression (progression=20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in opinion of treating physician, any new lesion/site, death due to disease)if known or the date the subject went off protocol if they were still considered responders (ie do not qualify as progression) or are stable (Does not qualify for CR, PR, progression or Symptomatic Deterioration)|1 week to 96 weeks|Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.|||weeks||Full Range|Median
1289462|NCT00130520|Secondary|Progression Free Survival(PFS)|PFS was defined as the time from the start of therapy to the time of the first documentation of progression(progression=20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, Death due to disease), symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause;|June 2005 to October 5, 2009|The population analyzed included all participants receiving at least 1 dose of study intervention and at least one assessment post-baseline. One subject was not evaluable. Analysis was per protocol|||months||Full Range|Median
1289463|NCT00130520|Primary|Objective Response (Complete Partial, Stable and Progression)|Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria|06.16.2005 to 10.05.2009|Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.|||Participants|||Number
1289464|NCT00130286|Secondary|Change in Subcutaneous Adipose Tissue Volume|"Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI~Data are presented only for subjects who had MRI scans done at both time points."|12 weeks||||L||Standard Deviation|Mean
1289465|NCT00130286|Secondary|Change in Visceral Adipose Tissue Volume|"Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI~Data are presented only for subjects who had MRI scans done at both time points."|12 weeks||||L||Standard Deviation|Mean
1289466|NCT00130286|Primary|Change in Insulin Sensitivity|"Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test~This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points."|12 weeks||||uU*10^-4*min*ml^-1||Inter-Quartile Range|Median
1289467|NCT00130247|Secondary|Microbiologic: Time After Inoculation Until Culture Positive in BACTEC 460 or MGIT 960 Enriched Liquid Media After 2 Months in Treatment - Results Are Pending||Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 24, and 30|||||||
1289525|NCT00129766|Primary|Number of Participants Who Died||Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
1289468|NCT00130247|Primary|Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-TB Treatment - Per-protocol|Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.|30 months|The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.|||Participants|||Number
1289469|NCT00130247|Secondary|Microbiologic: Changes in Sputum Mycobacterial mRNA - Results Are Pending||At 1 and 2 months of anti-TB treatment, and upon relapse|||||||
1289470|NCT00130247|Secondary|Immunologic: Changes in Sputum Cytokine Levels - Results Are Pending||After 1 and 2 months of anti-TB treatment|||||||
1289471|NCT00130247|Secondary|Immunologic: Store Peripheral Blood Mononuclear Cells (PBMC) - Results Are Pending||Pre-treatment and serum pre-treatment after 2 and 6 months of anti-TB treatment, and at the time of relapse for future immunologic analysis|||||||
1289472|NCT00130247|Secondary|Immunologic: Changes in Cytokine Levels in Mycobacterium Tubercolosis (MTB) Antigen-stimulated Whole Blood Culture Supernatants - Results Are Pending||After 2 and 6 months of anti-TB treatment and upon relapse|||||||
1289473|NCT00130247|Secondary|Acquired Drug Resistance in Patients Who Relapsed||2 years|This analysis was per protocol and looked for acquired drug resistance among the 13 patients in the 4-Month Arm who relapsed and the 3 patients in the 6-Month Arm who relapsed.|||Participants|||Number
1289474|NCT00130247|Secondary|Relapses at 1 and 2 Years||1 and 2 years after successful completion of initial anti-TB treatment|Analysis includes the 386 patients who received the intervention, completed treatment, and started post-treatment follow-up (193 patients in each treatment arm). Two subjects were lost after completing treatment and contributed no follow-up time, and 6 subjects did not receive the intervention so were not included in the analysis.|||Participants|||Number
1289475|NCT00130247|Secondary|Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol|A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.|2 years|The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.|||Participants|||Number
1289476|NCT00130247|Secondary|Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat|A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.|2 years|The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.|||Participants|||Number
1289477|NCT00130247|Primary|Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat|Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.|30 months|The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.|||Participants|||Number
1289478|NCT00130208|Secondary|Change in Serum Albumin From Baseline to End of 26 Weeks||26 Weeks|Participant numbers include those with both baseline and week 26 measurements|||percent change||Standard Error|Least Squares Mean
1289479|NCT00130208|Primary|Number of Subjects With Greater Than 50% Reduction in Microalbuminuria|During the treatment period, KRX-101 is being compared to placebo to assess whether a 50% reduction in microalbuminuria has been achieved.|26 Weeks||||Participants|||Count of Participants
1289480|NCT00130208|Primary|Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria|The primary efficacy variable was the fraction of those patients in the ITT population with valid baseline and Week 26 ACRs in whom “therapeutic success” was achieved at Week 26 measured as a conversion of microalbuminuria to normoalbuminuria and at least a 25% reduction in ACR relative to baseline|26 Weeks||||Participants|||Count of Participants
1289481|NCT00130117|Secondary|Hip BMD||9months||||g/cm2||Inter-Quartile Range|Median
1289482|NCT00130117|Secondary|Radial BMD||9 months||||g/cm2||Inter-Quartile Range|Median
1289483|NCT00130117|Secondary|Lumbar BMD||9 months||||g/cm2||Inter-Quartile Range|Median
1289484|NCT00130117|Secondary|Total Body BMD||9 months||||g/cm2||Inter-Quartile Range|Median
1289485|NCT00130117|Secondary|Body Fat||36 weeks||||fat %||Standard Error|Mean
1289486|NCT00130117|Secondary|Total Body BMD||36 weeks||||g/cm^2||Inter-Quartile Range|Median
1289487|NCT00130117|Secondary|Body Composition BMI||36 weeks||||BMI-kg/m^2||Standard Error|Mean
1289490|NCT00130039|Secondary|Numbers of Fatal or Major Bleeding Complications|life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood|upto 7 months after randomization|this outcome analysis was done ITT method|||events|||Number
1289491|NCT00130039|Secondary|Number of Patients With Ipsilateral Ischemic Stroke Rate|ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis|upto 7 months after randomization|this outcome analysis was done ITT method|||participants|||Number
1289492|NCT00130039|Secondary|Number of Participants With Overall Cardiovascular Events|including nonfatal stroke, nonfatal myocardial infarction and vascular death.|upto 7 months after randomization|this outcome analysis was done intention to treat method|||participants|||Number
1289493|NCT00130039|Secondary|Number of Participants With Stroke Events|including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke|upto 7 months after randomization|this outcome analysis performed on the intention to treat (ITT) method|||participants|||Number
1289494|NCT00130039|Secondary|Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI|number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI.|7 months after treatment|this analysis included the patients who had performed follow-up FLAIR imaging|||pariticipants|||Number
1289495|NCT00130039|Primary|Number of Participants With Progression of Symptomatic Intracranial Stenosis|"Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA.~The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA."|7 months after treatment||||participants|||Number
1289496|NCT00129974|Secondary|Number of Participants With at Least One Adverse Event|Number of Participants with at least one Adverse Event|Study Termination|||||||
1289497|NCT00129974|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Study Termination|||||||
1289498|NCT00129961|Secondary|Spot Urine Protein:Creatinine Ratio|Subjects’ urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups.|At 24 months (Week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. Available data, no imputations.|||ratio (mg/mg)||Full Range|Median
1289499|NCT00129961|Secondary|Number of Subjects With Biopsy-Confirmed Acute Rejection||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||subjects|||Number
1289500|NCT00129961|Secondary|Graft Survival Measured by Graft Loss|Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||graft loss|||Number
1289501|NCT00129961|Secondary|Number of Participants That Died||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
1289502|NCT00129961|Secondary|Serum Creatinine Level|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass.|At 24 months (Week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. All available data, no imputations.|||μmol/L||Standard Deviation|Mean
1289503|NCT00129961|Secondary|Nankivell-Calculated Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|At 24 months (week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. For the intention to treat analysis, a GFR of 0 was imputed for graft loss or death, and last observation carried forward (LOCF) for missing values.|||units on scale||Standard Deviation|Mean
1289504|NCT00129961|Secondary|Number of Subjects Who Discontinue Assigned Therapy||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
1289505|NCT00129961|Secondary|Death Due to NMSC||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
1289506|NCT00129961|Secondary|Subjects Reporting Incidence of Metastatic Disease Related to NMSC.|The number of subjects with metastatic disease related to NMSC.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
1289509|NCT00129961|Secondary|Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||Percentage of Participants|||Number
1289510|NCT00129961|Secondary|Number of Lesion Free Subjects|The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
1289511|NCT00129961|Secondary|Time to First Biopsy Confirmed New NMSC Lesion.|The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||number of days||95% Confidence Interval|Median
1289512|NCT00129961|Primary|New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year|The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||Standardized Yearly Rate of NMSC|||Number
1289513|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4|Mean serum concentrations of motavizumab at 30 days post Dose 4|30 days post Dose 4|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements|||ug/mL||Standard Deviation|Mean
1289514|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3|Mean serum concentrations of motavizumab at 30 days post Dose 3|30 days post Dose 3|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements|||ug/mL||Standard Deviation|Mean
1289515|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2|Mean serum concentrations of motavizumab at 30 days post Dose 2|30 days post Dose 2|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements|||ug/mL||Standard Deviation|Mean
1289516|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1|Mean serum concentrations of motavizumab at 30 days post Dose 1|30 days post Dose 1|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements|||ug/mL||Standard Deviation|Mean
1289517|NCT00129766|Secondary|The Serum Concentrations of Motavizumab at Day 0|Mean serum concentrations of motavizumab at Day 0|Day 0|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug.|||ug/mL||Standard Deviation|Mean
1289518|NCT00129766|Secondary|The Number of Participants With Anti-motavizumab Antibodies|Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.|Day 0 - 120|N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217|||participants|||Number
1289519|NCT00129766|Secondary|The Frequency of Prescribed Antibiotics for Medically-attended OM Infections|The average number of presciptions per event per subject was summarized for each treatment group.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||number of prescriptions||Standard Deviation|Mean
1289520|NCT00129766|Secondary|The Frequency of Prescribed Antibiotics for Medically-attended LRI|The average number of presciptions per event per subject was summarized for each treatment group.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||Number of prescriptions||Standard Deviation|Mean
1289521|NCT00129766|Secondary|The Incidence of Medically-attended Otitis Media (OM) Infections|Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||Participants|||Number
1289522|NCT00129766|Secondary|The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups|The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.|Days 0 - 150|Subjects were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint.|||Participants|||Number
1289523|NCT00129766|Secondary|The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)|LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.|Day 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||Participant|||Number
1289528|NCT00129766|Primary|Number of Participants Reporting Any Related SAEs|Number of participants reporting one or more SAEs considered related to study drug by the investigator|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
1289529|NCT00129766|Primary|Number of Participants Reporting Any Serious Adverse Events (SAEs)|Number of participants reporting one or more SAEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
1289530|NCT00129766|Primary|Number of Participants Reporting Any Related AEs|Number of participants reporting one or more AEs considered related to study drug by the investigator|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
1289531|NCT00129766|Primary|Number of Participants Reporting Any Adverse Events (AEs)|Number of participants reporting one or more AEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
1289532|NCT00129766|Primary|Incidence of RSV Hospitalization (Includes Deaths by RSV)|RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||Participants|||Number
1289533|NCT00129727|Secondary|Toxicity|Per CTCAE (Common Toxicity Criteria for Adverse Events) number of participants who experienced toxicity on the study|60 months||||Participants|||Number
1289534|NCT00129727|Secondary|Response Rate (RECIST-1)|To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab. Evaluate toxicity.|5 years||||Percentage of Participants||95% Confidence Interval|Number
1289535|NCT00129727|Primary|PFS|Progression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer|Median PFS in months - up to 5 years||||Months||95% Confidence Interval|Median
1289536|NCT00129623|Secondary|Number of Participants With Marked Laboratory Abnormalities|Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride].|Screening up to 12 months|The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.|||participants|||Number
1289537|NCT00129623|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 15 days after end of study treatment (Approximately 2 years)|The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.|||participants|||Number
1289538|NCT00129623|Secondary|Percentage of Responders|Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites.|Up to 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||Percentage|||Number
1289539|NCT00129623|Secondary|Absolute Change From Baseline in sCTX|Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.|Baseline and 3, 6, 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.|||ng/ml||95% Confidence Interval|Median
1289540|NCT00129623|Secondary|Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)|Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.|Baseline and 3, 6 and 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.|||Percentage||95% Confidence Interval|Median
1289541|NCT00129623|Secondary|Absolute Change From Baseline in BMD of the Proximal Femur at Month 12|BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||g/cm^2||Standard Deviation|Mean
1297086|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 48||Baseline to Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1289542|NCT00129623|Secondary|Relative Change From Baseline in Mean Proximal Femur BMD at Month 12|BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||Percentage||Standard Deviation|Mean
1289543|NCT00129623|Secondary|Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12|BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||g/cm^2||Standard Deviation|Mean
1289544|NCT00129623|Primary|Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12|BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||Percentage||Standard Error|Least Squares Mean
1289545|NCT00129545|Secondary|Procedure Success|Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.|Initial implant procedure|14 subjects did not have an implant procedure attempted|||percentage of implant attempts|||Number
1289546|NCT00129545|Primary|The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events|Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.|5 years|"Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics~Roll-in subjects were not included in the primary outcome analysis per study design."|||Events per 100 pt-yrs||95% Confidence Interval|Number
1289547|NCT00129545|Primary|Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death|A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)|5 years|"event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics~Roll-in subjects were not included in the primary outcome analysis per study design."|||events per 100 pt yrs||95% Confidence Interval|Number
1289548|NCT00129480|Secondary|Depression Severity (Patient Health Questionnaire-depression Rating Scale at 6 and 12 Months); Clinician Adherence to Clinical Guidelines for Chronic Pain (Chart Review Conducted at 12 Months); Patient and Provider Satisfaction Questionnaires Completed||baseline, 3 month, 6 month, 12 month|||||||
1289549|NCT00129480|Primary|Pain-related Function (Roland Disability Score) at 12 Months|The Roland Morris Disability Questionnaire has 24 yes or no items. Each item is scored as 0 or 1. Item scores or summed to create total score with range 0 to 24. Higher scores represent greater disability. the Roland Morris has been widely used, has content and construct validity, internal consistency, and responsiveness to change among patients with chronic pain.|12 months||||Adjusted percent change||95% Confidence Interval|Mean
1289550|NCT00129467|Primary|Days to Remission of Depression|Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score.|18 Days|The number of participants analyzed is the number of who received the intervention|||Days||Standard Error|Mean
1289551|NCT00129441|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex|"The Delayed Memory Index consists of verbal and nonverbal recall tasks (words, drawings) that the subject views early in the evaluation and without warning, is asked to recall ~1/2 hr later. Scores are expressed as standardized scores normalized to a population mean of 100, with a standard deviation of 15 (possible scores between 40-135). Higher scores reflect better performance. Subjects received the A form at baseline and wk-4 visit and the B form at the wk-2 visit (A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects)."|Week 4|One subject dropped out before completing the study.|||Standard Score||Standard Deviation|Mean
1289552|NCT00129441|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score|"Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. All subjects received the A form at baseline and the wk-4 visit and the B form at the wk-2 visit (the A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects)."|Week 4|One subject dropped out before completing the study.|||Standard Score||Standard Deviation|Mean
1289553|NCT00129441|Secondary|Brief Psychiatric Rating Scale Total Score|The Brief Psychiatric Rating Scale-anchored (BPRS; Overall and Gorham, 1962; Woerner, Mannuzza, Kane, 1988) is an 18-item scale that is among the most widely used measure of psychopathology. Scores range from 1-7, with higher scores reflecting greater pathology. A total score is derived from the sum of all 18 items (possible scores range from 18-126). It relies on clinical judgment in the assessment of key areas of psychopathology (depression, anxiety, psychosis).|Week 4|One subject dropped out prior to completing study|||Scores on a scale||Standard Deviation|Mean
1289554|NCT00129441|Primary|Preparing to Overcome Prepotency Task - Error Rate|The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.|Week 4||||proportion of errors||Standard Deviation|Mean
1289555|NCT00129441|Primary|Preparing to Overcome Prepotency (POP) Task - Reaction Time|The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.|Week 4||||msec||Standard Deviation|Mean
1289556|NCT00129441|Primary|AX Continuous Performance Test Task D-prime|For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.|Week 4|Four subjects did not complete a sufficient number of trials for the AXCPT task at both testing periods, therefore 7 L-830982 and 4 placebo subjects data were analyzed.|||d-prime||Standard Deviation|Mean
1289557|NCT00129441|Primary|N-back Task - Error Rate|The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.|Week 4|Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.|||proportion of errors||Standard Deviation|Mean
1289558|NCT00129441|Primary|N-back Task - Reaction Time|The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.|Week 4|Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.|||msec||Standard Deviation|Mean
1289559|NCT00129402|Secondary|Percent Change From Baseline in HDL-C||baseline to 6 weeks|ITT|||percent change||Standard Error|Least Squares Mean
1289560|NCT00129402|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)||baseline to 6 weeks|ITT|||percent change||Standard Error|Least Squares Mean
1289561|NCT00129402|Secondary|Percent Change From Baseline in Triglycerides (TG)||baseline to 6 weeks|ITT|||percent change||Standard Deviation|Median
1289562|NCT00129402|Secondary|Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)||baseline to 6 weeks|ITT|||percent change||Standard Error|Least Squares Mean
1289563|NCT00129402|Secondary|Percent Change From Baseline in Total Cholesterol (TC)||baseline to 6 weeks|ITT|||percent change||Standard Error|Least Squares Mean
1289564|NCT00129402|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Least squares mean percent change from Baseline in LDL-C at the end of Step 1 (Week 6) in the pooled groups who received ezetimibe plus simvastatin compared with pooled groups who received simvastatin monotherapy|baseline to 6 weeks|The analysis was performed on the intent to treat (ITT) population. Although 248 subjects received randomized treatment, two of the subjects did not have at least one baseline and at least one postbaseline lipid determination and thus could not be analyzed in the ITT population. Therefore, the actual ITT population consisted of 246 subjects.|||percent change||Standard Error|Least Squares Mean
1289565|NCT00129311|Primary|7 Day Point Prevalence of Cigarette Abstinence||Week 8||||participants|||Number
1289566|NCT00129311|Primary|7 Day Point Prevalence of Cigarette Abstinence||6-month follow up||||participants|||Number
1289567|NCT00129285|Secondary|Cocaine Selective Severity Assessment (CSSA) Total Score|Cocaine Selective Severity assessment (CSSA) total score has a range 0-126. Higher scores indicating greater severity of cocaine withdrawal obtained weekly. Groups compared using GEE model over 8 weeks of treatment.|8 weeks|patients exposed to low dose and high dose modafinil|||units on a scale||Standard Deviation|Mean
1289568|NCT00129285|Secondary|Retention; Number of Evaluation Visits Attended|Number of visits attended compared between the three conditions using anova|8 weeks||||number of evaluation sessions attended||Standard Deviation|Mean
1289569|NCT00129285|Primary|Urine Toxicology for Cocaine|Abstinent in the final 3 weeks of treatment|3 weeks||||Participants|||Count of Participants
1289570|NCT00129272|Secondary|Withdrawal Symptoms|Hughes-Hatsukami Withdrawal Scale|Nine weeks|Analyzed all participants with last observation carried forward (LOCF).|||units on a scale;range0-36;higher worse||Standard Deviation|Mean
1289571|NCT00129272|Primary|Smoking Behavior|Number of cigarettes smoked daily in the previous week|Nine weeks|Analyzed all randomized participants with last observation carried forward (LOCF).|||cigarettes/day in the previous week||Standard Deviation|Mean
1289572|NCT00129259|Secondary|Change in Average Total Insulin Dose Per Body Weight|This measure is computed using the average amount of exogenous insulin taken per day for the 3 days prior to the visit. The average insulin use is divided by the subject's weight in kilograms (kg). The need for lower dose(s) of prescribed exogenous insulin while maintaining optimal control of a subject's diabetes reflects improved management of the underlying disease.|Baseline (Pre-treatment), Month 24|Intent-to-treat with available data|||Units of Insulin/kilogram/day (U/kg/day)||Standard Deviation|Mean
1289573|NCT00129259|Secondary|Change in HbA1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time and measures the level of optimal management of underlying disease. (Normal :< 5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher).A decline in HbA1c from baseline to month 24 signifies an improvement in diabetic control. The goal of treatment: to maintain the HgA1c level as close to normal as possible without frequent occurrence of hypoglycemia.|Baseline (Pre-treatment), Month 24|Intent-to-treat with available data|||Percentage (%)||Standard Deviation|Mean
1289574|NCT00129259|Primary|Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT)|C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT. The baseline data was used to adjust for the C-peptide AUC primary endpoint at 24 months. Missing month 24 C-peptide results are imputed using a conservative scenario.|Baseline (Pre-treatment), Month 24|Intent-to-treat|||pmol/mL||95% Confidence Interval|Least Squares Mean
1289575|NCT00129246|Primary|Weight Gain|Weight gain for for the entire sample in pounds at 6 weeks.|Week 6|Per protocol analysis|||lbs||Standard Deviation|Mean
1289576|NCT00129246|Secondary|Weight Gain Abstinent Participants|Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.|Week 6|Per protocol analysis|||lbs||Standard Deviation|Mean
1289577|NCT00129246|Primary|Point Prevalence Abstinence|Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.|Week 6|Per protocol analysis|||participants|||Number
1289578|NCT00129246|Primary|Smoking Cessation|Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.|Week 6|Per protocol analysis|||participants|||Number
1289579|NCT00129220|Secondary|Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score|Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).|Baseline to 6 weeks|Participants in the Safety Analysis Set (participants who had baseline and post-baseline measurements). Participants were included in the treatment group for which they actually received treatment.|||units on a scale||Standard Deviation|Mean
1289580|NCT00129220|Secondary|Percentage of Participants Who Switched to Syndromic Depression|Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).|3 weeks, 6 weeks|Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had manic (not mixed) episode at baseline.|||percentage of participants|||Number
1289581|NCT00129220|Secondary|Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)|Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1289582|NCT00129220|Secondary|Percentage of Participants Who Switched to Symptomatic Depression|Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|3 weeks, 6 weeks|Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had HAMD-17 total scores ≤7 at baseline.|||percentage of participants|||Number
1289583|NCT00129220|Secondary|Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks|Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.|3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||percentage of participants|||Number
1289584|NCT00129220|Secondary|Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks|Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||percentage of participants|||Number
1289585|NCT00129220|Secondary|Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale|A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1289586|NCT00129220|Secondary|Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness|A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1290437|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|20 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1289587|NCT00129220|Secondary|Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)|Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.|6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||percentage of participants|||Number
1289588|NCT00129220|Secondary|Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1289589|NCT00129220|Primary|Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 3 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1289590|NCT00129129|Secondary|Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)|Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).|Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1289591|NCT00129129|Secondary|Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses|Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1289592|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1289593|NCT00129129|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1289594|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1289595|NCT00129129|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period following the fourth dose|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1289596|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. “Any”= any report of the specified symptom irrespective of intensity and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; “Grade 3” for Drowsiness, Irritability/Fussiness = prevented normal activity; “Grade 3” Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); “Grade 2 or 3” for fever = T >39.0°C; “Grade 3” for fever = T >40.0°C|Within 8 days (Day 0-7) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1289597|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. “Any”= any report of the specified symptom irrespective of intensity and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; “Grade 3” for Drowsiness, Irritability/Fussiness = prevented normal activity; “Grade 3” Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); “Grade 2 or 3” for fever = T >39.0°C; “Grade 3” for fever = T >40.0°C|Within 4 days (Day 0-3) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1290438|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|10 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1289598|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. “Any”= any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling >10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling >30 mm; “Grade 2” limb circumference (LC) = LC >20 mm; “Grade 3” LC = LC >40 mm|Within 8 days (Day 0-7) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
1289599|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. “Any”= any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling >10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling >30 mm; “Grade 2” limb circumference (LC) = LC >20 mm; “Grade 3” LC = LC >40 mm|Within 4 days (Day 0-3) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase|||Participants|||Count of Participants
1289600|NCT00129129|Secondary|Anti-tetanus Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1289601|NCT00129129|Secondary|Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)||Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289602|NCT00129129|Secondary|Anti-PSY Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1289603|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289604|NCT00129129|Secondary|Anti-PSC Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1289605|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289606|NCT00129129|Secondary|hSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1289607|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values|hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289608|NCT00129129|Secondary|hSBA-MenC Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1289609|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values|hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289610|NCT00129129|Secondary|rSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1289611|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values|rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289612|NCT00129129|Secondary|rSBA-MenC Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1289613|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values|rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289614|NCT00129129|Secondary|Anti-PRP Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1289615|NCT00129129|Secondary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289616|NCT00129129|Secondary|Concentration of Antibodies Against Streptococcus Pneumonia Serotypes|"Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1289617|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289618|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289677|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-diphtheria Antibodies|Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289619|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289620|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)|"Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2):~Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8),~At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8,~At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289621|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)|"Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1):~Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16),~Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289622|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)|"Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2):~Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8),~At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128,~At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289623|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)|"Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1):~Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32),~Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
1289624|NCT00129129|Secondary|Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians’ Office, Related or Not to Common Illnesses|Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289625|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289626|NCT00129129|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1290638|NCT00120250|Primary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 24-item, patient-administered scale that assess changes in sleep symptomatology. The total PSQI score ranges from 0 to 21 where a higher value indicates a worse sleep symptomatology.|8 weeks||||units on a scale||Standard Deviation|Mean
1289627|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289628|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289629|NCT00129129|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289630|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. “Any” = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; “Grade 3” for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; “Grade 3” Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); “Grade 2 or 3” fever = rectal temperature higher than (>) 39°C; “Grade 3” fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups|Within 8 days (Day 0-7) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289631|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. “Any” = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; “Grade 3” for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; “Grade 3” Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); “Grade 2 or 3” fever = rectal temperature higher than (>) 39°C; “Grade 3” fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 4 days (Day 0-3) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289632|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling at injection site. “Any” = any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 8 days (Day 0-7) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289633|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling at injection site. “Any” = any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 4 days (Day 0-3) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289634|NCT00129129|Secondary|Number of Subjects With Vaccine Response to PT, FHA and PRN|Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration </≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289678|NCT00129116|Secondary|Anti-poliovirus Types 1, 2, 3 Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Titers||95% Confidence Interval|Geometric Mean
1289635|NCT00129129|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Titers||95% Confidence Interval|Geometric Mean
1289636|NCT00129129|Secondary|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289637|NCT00129129|Secondary|Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to the primary vaccination course (at Day 0)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1289638|NCT00129129|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289639|NCT00129129|Secondary|Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||mIU/mL||95% Confidence Interval|Geometric Mean
1289640|NCT00129129|Secondary|Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289641|NCT00129129|Secondary|Anti-diphtheria and Anti-tetanus Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||IU/mL||95% Confidence Interval|Geometric Mean
1289642|NCT00129129|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)|The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289643|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289644|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289645|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289646|NCT00129129|Secondary|Anti-PRP Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||µg/mL||95% Confidence Interval|Geometric Mean
1289647|NCT00129129|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values|Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289648|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject . This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289649|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289650|NCT00129129|Secondary|Number of Subjects Reporting Medically Attended Visits|A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289651|NCT00129129|Secondary|Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||µg/mL||95% Confidence Interval|Geometric Mean
1289652|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values|Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289653|NCT00129129|Secondary|Anti-polysaccharide C (Anti-PSC) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||µg/mL||95% Confidence Interval|Geometric Mean
1289654|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values|Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289722|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone|Parathyroid hormone: Any increase in PTH was considered response|6 months||||participants|||Number
1289655|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4|A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.|One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289656|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4|A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.|One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289657|NCT00129129|Secondary|Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Titers||95% Confidence Interval|Geometric Mean
1289658|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values|rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289659|NCT00129129|Secondary|Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Titers||95% Confidence Interval|Geometric Mean
1289660|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values|rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
1289661|NCT00129129|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value|The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .|One month after the fourth dose (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies 1 month (31 to 48 days) after the administration of the fourth dose.|||Participants|||Count of Participants
1289662|NCT00129129|Primary|Number of Subjects Reporting Any Grade 3 Symptoms|“Symptoms” were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A “Grade 3” symptom was defined as any symptom that prevented normal everyday activity. “Any” was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|During the 4-day follow-up period after each primary vaccine dose|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
1289663|NCT00129129|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1289664|NCT00129129|Primary|Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||µg/mL||95% Confidence Interval|Geometric Mean
1289665|NCT00129129|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.|The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures, with no elimination criteria) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase|||Participants|||Count of Participants
1289666|NCT00129116|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Over the full course of the booster phase (up to study Month 1 – booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.|||Subjects|||Number
1289667|NCT00129116|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.|||Subjects|||Number
1289668|NCT00129116|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).|During the 8-day (Day 0-7) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.|||Subjects|||Number
1289669|NCT00129116|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 8-day (Day 0-7) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.|||Subjects|||Number
1289670|NCT00129116|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Over the full course of the primary phase (up to study Month 3 – primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.|||Subjects|||Number
1289671|NCT00129116|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.|||Subjects|||Number
1289672|NCT00129116|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).|During the 8-day (Day 0-7) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.|||Subjects|||Number
1289673|NCT00129116|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 8-day (Day 0-7) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.|||Subjects|||Number
1289674|NCT00129116|Secondary|Number of Subjects With Vaccine Response to PT, FHA and PRN|Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289675|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies|Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289676|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-hepatitis B Antibodies|Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289679|NCT00129116|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||mIU/mL||95% Confidence Interval|Geometric Mean
1289680|NCT00129116|Secondary|Anti-diphtheria Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1289681|NCT00129116|Secondary|Anti-T Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1289682|NCT00129116|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).|Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289683|NCT00129116|Secondary|Anti-PSY Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1289684|NCT00129116|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1289685|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289686|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289687|NCT00129116|Secondary|rSBA-MenY Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Titres||95% Confidence Interval|Geometric Mean
1289688|NCT00129116|Secondary|rSBA-MenC Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1289689|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128|rSBA-MenY antibody titre cut-off value assessed was ≥1:128|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289690|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128|rSBA-MenC antibody titre cut-off value assessed was ≥1:128|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289691|NCT00129116|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1289692|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289693|NCT00129116|Secondary|Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)|Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289694|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-tetanus Antibodies|Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289695|NCT00129116|Secondary|Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||EL.U/mL||95% Confidence Interval|Least Squares Mean
1289696|NCT00129116|Secondary|Anti-tetanus Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1289697|NCT00129116|Secondary|Anti-PSY Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
1289698|NCT00129116|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
1289699|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289700|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289701|NCT00129116|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
1289702|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289703|NCT00129116|Secondary|rSBA-MenY Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Titers||95% Confidence Interval|Geometric Mean
1289704|NCT00129116|Secondary|rSBA-MenC Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Titers||95% Confidence Interval|Geometric Mean
1289705|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289706|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289707|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289708|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289709|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289710|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289711|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289712|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289713|NCT00129116|Primary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
1289714|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289715|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289716|NCT00129116|Primary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
1289717|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.|Phosphate: any Phosphate increase would refer to a positive response.|6 months||||participants|||Number
1289718|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium|Magnesium: Any Magnesium increase would refer to a positive response.|6 months||||participants|||Number
1289719|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase|Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response|6 months||||participants|||Number
1289720|NCT00128921|Secondary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin|Osteocalcin: Any Osteocalcin increase means positive response.|6 months||||participants|||Number
1289721|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium|Calcium: any Calcium increase would refer to a positive response.|6 months||||participants|||Number
1289724|NCT00128830|Secondary|Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)|Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study [TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies]) and are present at endpoint (last available timepoint during treatment period for each individual participant).|Baseline and Endpoint (ie, the last available time point during the treatment period)|Intent-to-treat population: Participants who received at least 1 dose of study medication were included|||Participants|||Number
1289725|NCT00128830|Secondary|Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 192|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192|||x 1000000 cells/mL||Full Range|Median
1289726|NCT00128830|Secondary|Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96|||x 1000000 cells/mL||Full Range|Median
1289727|NCT00128830|Secondary|Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96|The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96|||x 1000000 cells/L||Full Range|Median
1289728|NCT00128830|Secondary|Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48|The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 48|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48|||x 100000 cells/L||Full Range|Median
1289729|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 192|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192|||Participants|||Number
1289730|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96|||Participants|||Number
1289731|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96|Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96|||Participants|||Number
1289732|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48|Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 48|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48|||Participants|||Number
1289733|NCT00128713|Secondary|Highest Grade of Bleeding While on Study|Highest grade of bleeding during time on study using Platelet Dose Trial modification of World Health Organization Bleeding Scale. Grades 0-1 (no or minimal bleeding), 2 (moderate bleeding), 3 (bleeding generally requiring red cell transfusion), 4 (severe bleeding)|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|The analysis was done as intention to treat. Subjects for which highest grade of bleeding could not be determined (non-evaluable) were excluded.|||participants|||Number
1289734|NCT00128713|Secondary|Bleeding Severity, if a Suitable Scale is Validated and Published by the Time the Trial Ends|No suitable scale was identified, so no analyses for this outcome were carried out|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Analysis not performed; no applicable bleeding severity scale validated and published by end of PLADO Study||||||
1289735|NCT00128713|Secondary|Number of Platelet Transfusion Episodes|Number of platelet transfusion episodes among subjects who have at least one platelet transfusion and no missing data on attempted doses.|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.|||Number of platelet transfusion episodes||Full Range|Median
1289770|NCT00128492|Primary|Change in Respiratory Rate (RR)|"RR was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||breaths/minute||Standard Deviation|Mean
1289736|NCT00128713|Secondary|Platelet Utilization|Total number of platelets transfused, based on attempted dose, among subjects who have at least one platelet transfusion and no missing data on attempted doses.|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.|||Number of platelets (x10^11)||Full Range|Median
1289737|NCT00128713|Primary|At Least One Day With Grade 2 or Higher Bleeding|Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|These analyses were done on an intention-to-treat basis. That is, patients were counted in the treatment arm to which they were randomly assigned, even if they actually received transfusions that were not according to their assigned dosing strategy.|||participants|||Number
1289738|NCT00128661|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|within 30 days (Days 0-29) after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1289739|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From the fourth year follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
1289740|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the third year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
1289741|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the second year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
1289742|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the first year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
1289743|NCT00128661|Secondary|Number of Subjects With All Possible Pregnancy Outcomes|The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy.|During the entire study period (From Month 0 up to Month 48).|The analysis was performed on the Total Vaccinated Cohort, on all pregnant subjects.|||subjects|||Number
1289744|NCT00128661|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the entire study period (From Month 0 up to Month 48).|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1289745|NCT00128661|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (From Month 0 up to Month 48).|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1289746|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.|From Day 3 to Day 6 after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1289771|NCT00128492|Primary|Change in Temperature|"Temperature was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||degrees Celsius||Standard Deviation|Mean
1289747|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|From Day 3 to Day 6 after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1289748|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.|Within 60 minutes after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1289749|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|Within 60 minutes after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1289750|NCT00128661|Secondary|HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs).~Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination.~Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination.~Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.|||Titers||95% Confidence Interval|Geometric Mean
1289751|NCT00128661|Secondary|HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs).~Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination.~Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination.~Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.|||Titers||95% Confidence Interval|Geometric Mean
1289752|NCT00128661|Secondary|Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs).~Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination.~Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination.~Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.|||Titers||95% Confidence Interval|Geometric Mean
1289753|NCT00128661|Secondary|Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs).~Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination.~Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination.~Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)"|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.|||Titers||95% Confidence Interval|Geometric Mean
1289772|NCT00128492|Secondary|Time to Intravenous (IV) Antipseudomonal Antibiotics|Use of IV antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. The time to first IV antipseudomonal antibiotic use was the number of days from baseline (Visit 1) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit) /or early withdrawal if censored.|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Days||95% Confidence Interval|Median
1289754|NCT00128661|Secondary|Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases|"Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type.~Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months.~Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type."|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
1289755|NCT00128661|Secondary|Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen.~Note: The assay did not distinguish between HPV types 68 and 73.~CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer~Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type"|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
1289756|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
1289757|NCT00128661|Primary|Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.|"CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer.~Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained.~Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type."|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
1289758|NCT00128492|Primary|Serum Chemistry - Concentration of Total Protein||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||g/dL||Standard Deviation|Mean
1289759|NCT00128492|Primary|Serum Chemistry - Concentration of Chloride, Potassium, and Sodium||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||mEq/L||Standard Deviation|Mean
1289760|NCT00128492|Primary|Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||mg/dL||Standard Deviation|Mean
1289761|NCT00128492|Primary|Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||U/L||Standard Deviation|Mean
1289762|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||g/dL||Standard Deviation|Mean
1289763|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Hemoglobin (MCH)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||pg||Standard Deviation|Mean
1289764|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Volume (MCV)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||fL||Standard Deviation|Mean
1289765|NCT00128492|Primary|Serum Hematology - Hemoglobin||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||g/dL||Standard Deviation|Mean
1289766|NCT00128492|Primary|Serum Hematology - Hematocrit||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||percent||Standard Deviation|Mean
1289767|NCT00128492|Primary|Serum Hematology - Number of Red Blood Cells (RBC)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||number x10^6/µL||Standard Deviation|Mean
1289768|NCT00128492|Primary|Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||percent of differential||Standard Deviation|Mean
1289769|NCT00128492|Primary|Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets||Baseline and end of Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI. Results obtained at the end of a 28-day treatment period are presented for selected timepoints.|||number of cells x10^3/µL||Standard Deviation|Mean
1289773|NCT00128492|Secondary|Missed School/Work Days Due to CF Symptoms|"Participants were provided with a diary card at each visit to record days of work and/or school missed due to their CF symptoms.~The percentage of school/work days missed was calculated as the total number of school/work days missed divided by the total number of on-study days multiplied by 100 across all participants in a treatment group."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Percentage of days missed||Standard Deviation|Mean
1289774|NCT00128492|Secondary|Change in Body Weight|Weight was measured at all visits and was reported to the nearest 0.1 kg/lb. Percent change in weight from baseline was calculated.|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Percent change from baseline||Standard Error|Mean
1289775|NCT00128492|Secondary|Time to First Hospitalization Due to a Respiratory Event|"Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) electronic case report form (eCRF).~Time to first hospitalization was the number of days from baseline (Visit 1) to the date of first hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Days||Full Range|Median
1289776|NCT00128492|Secondary|Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS)|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). The minimal clinically important difference (MCID) corresponds to the smallest change in symptoms that a patient can detect and is a change in score of 4 points.|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Units on a scale||Standard Deviation|Mean
1289777|NCT00128492|Secondary|Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75)|"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines.~FEV1 = the volume of air exhaled in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudson equation, based upon participant age, gender, and height. FVC = (forced vital capacity) the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC.~The percent change from baseline is presented for each endpoint."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Percent change from baseline||Standard Deviation|Mean
1289778|NCT00128492|Secondary|Minimum Inhibitory Concentration (MIC) of Aztreonam|"The aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||µg/mL|||Number
1289779|NCT00128492|Secondary|Number of Participants With Other Pathogens|"Sputum samples were collected at all study visits for qualitative and quantitative culture for Burkholderia cepacia complex (BCC), Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Staphylococcus aureus (including methicillin-sensitive [MSSA] and methicillin-resistant [MRSA] S.aureus), and fungal organisms.~Number of participants with other pathogens at baseline and end of AZLI treatment Courses 1, 3, and 9 are reported."|Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Participants|||Number
1289780|NCT00128492|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum|"Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype).~Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero."|Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Log10 PA CFUs/g||Standard Deviation|Mean
1289781|NCT00128492|Primary|Change in Systolic and Diastolic Blood Pressure (BP)|"BP was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||mm Hg||Standard Deviation|Mean
1289782|NCT00128492|Primary|Change in Heart Rate (HR)|"HR was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||beats/minute||Standard Deviation|Mean
1289783|NCT00128492|Primary|Number of Subjects With <15% or ≥15% Decline in Forced Expiratory Volume in 1 Second [FEV1] From Pretreatment to 30 Minutes After Treatment With AZLI|Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of ≥15% at any visit in which they received AZLI.|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Participants|||Number
1289784|NCT00128492|Primary|Number of Participants Reporting Adverse Events (AEs)|"Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death.~Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||participants|||Number
1289785|NCT00128401|Secondary|Liebowitz Social Anxiety Scale (LSAS)|"Social anxiety symptoms were assessed using the Liebowitz Social Anxiety Scale (LSAS). It is a 24-item self-report instrument that measures overall social anxiety fear and avoidance symptoms. This is the baseline assessment. The 24 items are each rated twice, from a 0 to 3 scale, with 0 indicated no level of symptom and 3 indicating a high level of the system. One rating is for anxiety, and the other is for avoidance. Thus, the lowest possible score is 0, and the highest possible score is 144. The total score represents the simple sum of all 48 ratings."|12 weeks post baseline|The analyses included only those subjects who were assigned to the DCS condition and placebo|||units on a scale||Standard Deviation|Mean
1289786|NCT00128401|Primary|Clinical Global Improvement (CGI-S) Scale|Symptom severity and improvement was assessed using the Clinical Global Impressions scale (CGI). It is a 2-item clinician-administered instrument that measures the patients' illness severity and global improvement. The minimum value for the CGI is 1=Normal, not at all ill and the maximum value is 7=Among the most extremely ill patients.|12 weeks post baseline|The analyses included only those subjects who were assigned to the DCS condition and placebo|||units on a scale||Standard Deviation|Mean
1289787|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 18|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 18. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 18|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289788|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 16|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 16. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 16|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289789|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 14|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 14. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 14|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289790|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 12|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 12. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 12|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289791|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 10|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 10. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 10|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289792|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 8|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 8. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 8|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289793|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 6|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 6. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 6|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289794|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 4|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 4. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 4|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289795|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 2|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 2. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 2|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289796|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 1|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 1. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 1|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289797|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 0|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 0 prior to vaccination.|Month 0|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
1289798|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits|Number of vaginal GBS III culture positive for 3+ consecutive visits was calculated from the post-vaccination visits over the 18 month follow-up. Status at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Participants|||Number
1289799|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive.|Number of participants whose vaginal swabs were type III GBS culture positive was calculated using data from the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up/final visit was imputed from the previous visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Participants|||Number
1289800|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study.|Number of participants who were vaginal type III GBS negative was calculated throughout the the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up /final visit was imputed from the subsequent visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Participants|||Number
1289801|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 18 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 18|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289802|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 16 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 16|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289803|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 14 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 14|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1290208|NCT00124735|Secondary|Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%|The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population|||minutes||Standard Deviation|Mean
1289804|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 12 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 12|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289805|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 10 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 10|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289806|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 8 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 8|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289807|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 6 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 6|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289808|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 4 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 4|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289809|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 2 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 2|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289810|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 1 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 1|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289811|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0|Blood samples were collected from participants at each scheduled clinic visit beginning with Month 0 prior to vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 0 prior to vaccination|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289812|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 18 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 18 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289813|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 16 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 16 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289814|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 14 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 14 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289815|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 12 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 12 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289816|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 10 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 10 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289817|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 8 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 8 month following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289818|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 6 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 6 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289819|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 4 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 4 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289820|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 2 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 2 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289839|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 28|The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289821|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 1 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 1 month following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
1289822|NCT00128219|Secondary|Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination|Fold-rises compare the IgG antibody level at post-vaccination to that obtained just prior to vaccination, for each visit during the 18-month follow-up period. Assay results at missed visits prior to loss to follow-up/final visit were not imputed.|Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Ratio||95% Confidence Interval|Mean
1289823|NCT00128219|Secondary|Number of Participants With Any Solicited Local and Systemic Symptoms.|Participants maintained a diary card to report the occurrence of solicited local and systemic symptoms for 7 days after vaccination. Participants are counted if they indicated experiencing the symptom at any severity during the reporting period.|Safety surveillance during the 1st 7 days.|The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).|||Participants|||Number
1289824|NCT00128219|Secondary|Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination.|The GMC was calculated from IgG antibody to type III GBS assay results on serum specimens obtained at clinic visits during the 18 month post-vaccination follow-up period. Results at missed visits prior to loss to follow-up/final visit were not imputed.|Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||µg/ml||95% Confidence Interval|Geometric Mean
1289825|NCT00128219|Primary|The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture.|Time to first acquisition of vaginal type III GBS was calculated as time from vaccination to the mid-point of the interval of ascertainment, censored by either the end of the follow-up period, or the first of 2 or more consecutive missed visits. Vaginal type III GBS status at missed visits prior to censoring was imputed from the subsequent visit.|Time from vaccination to acquisition of vaginal type III GBS, up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the intention to treat (ITT) Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Participants|||Number
1289826|NCT00128206|Secondary|Cost Effectiveness||course of treatment|||||||
1289827|NCT00128206|Secondary|Completion of Therapy||course of treatment|||||||
1289828|NCT00128206|Primary|Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication|Liver function tests were taken at regular intervals and clinical symptoms were reviewed at regular intervals in both study groups. On the basis of these tests and examinations, physicians determined whether the study drug needed to be stopped.|up to one year|The number of participants was determined by power calculations using estimates of toxicity from the literature. The analysis was intention to treat.|||participants|||Number
1289829|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen PPD|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1 and C1b who received the antigen are included in the analysis population.|||Participants|||Number
1289830|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.|||Participants|||Number
1289840|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1, B2, C1 and C1b who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1290962|NCT00117572|Secondary|Quality of Life (Speech)|Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)|Change from baseline to 1 year (1 year-pre)|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
1289831|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.|||Participants|||Number
1289832|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.|||Participants|||Number
1289833|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.|||Participants|||Number
1289834|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen PPD.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Groups C1 and C1b who received the antigen are included in the analysis population.|||Participants|||Number
1289835|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.|||Participants|||Number
1289836|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.|||Participants|||Number
1289837|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.|||Participants|||Number
1289838|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.|||Participants|||Number
1289841|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289842|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Groups A1 and A2 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289843|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B2 and C1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289844|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A2, B2 and C1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289845|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Group A2 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289846|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B2 and C1b who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289847|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A2, B2 and C1b who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289848|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1 and C1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289849|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A1, B1 and C1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289850|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Group A1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289851|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1 and C1b who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289852|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289853|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289854|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1293656|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 6|Laboratory hematology monocytes|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
1289855|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289856|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289857|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289858|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289859|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289860|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289861|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289862|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
1289863|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.|||Participants|||Number
1289864|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD)|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
1289865|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.|||Participants|||Number
1289866|NCT00128193|Primary|Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
1289867|NCT00128193|Primary|Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days||||Participants|||Number
1290007|NCT00126581|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|"The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Duration of study (up to 3 years)||||participants|||Number
1289868|NCT00128193|Primary|Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
1289869|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.|||Participants|||Number
1289870|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
1289871|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.|||Participants|||Number
1289872|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable erythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
1289873|NCT00128180|Secondary|Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry||6 months|Per protocol, this efficay analysis was limited to participants with confirmed hantavirus infection who did not have a serum creatinine equal or greater to 3.0 mg/dL at entry.|||participants|||Number
1289874|NCT00128180|Secondary|Length of Time on a Ventilator||6 months|Per protocol this efficacy analysis was limited to participants with confirmed hantavirus infection who were intubated and on a ventillator.|||days||Standard Deviation|Mean
1289875|NCT00128180|Secondary|Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry|Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output.|6 months|Per protocol, this efficacy analysis was limited to participants with confirmed hantavirus infection who were not already in shock at study entry.|||participants|||Number
1289876|NCT00128180|Secondary|Number of Participants Intubated and Placed on a Ventilator After Study Entry.|Participants|6 months|This efficacy this analysis was limited to participants with confirmed hantavirus infection who were not already intubated at study entry.|||participants|||Number
1289877|NCT00128180|Secondary|Duration of Shock and/or Pressor/Inotropic Support|Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output.|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.|||days||Standard Deviation|Mean
1289878|NCT00128180|Secondary|Duration of Hospital Stay in Days|Days|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantairus infection.|||days||Standard Deviation|Mean
1289879|NCT00128180|Secondary|Duration of ICU Stays||6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection, and this analysis was limited to those who were admitted to ICU. Four subjects with confirmed hantavirus infection were not admitted to ICU.|||days||Standard Deviation|Mean
1289880|NCT00128180|Secondary|Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)|number of participants|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.|||participants|||Number
1289881|NCT00128180|Primary|Number of Participants With SAEs|The Number of participants with SAEs|6 months|Per protocol, safety analysis inluded all participants, including those where hantavirus infection was not confirmed.|||participants|||Number
1289882|NCT00128180|Primary|The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation||28 days|Per protocol, the efficacy analysis was limited to participants with confirmed hantavirus infection.|||proportion of paticipants|||Number
1289883|NCT00127933|Secondary|Participants With Overall Survival|Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.|22 - 1191 days|The analysis was done on the post-operative Response Evaluable Population.|||participants|||Number
1289884|NCT00127933|Secondary|Participants With Disease-Free Survival|Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.|30 - 1102 days|The analysis was done on the Postoperative Response Evaluable Population.|||participants|||Number
1289885|NCT00127933|Secondary|Percentage of Participants With Local Recurrence|Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.|30 - 1102 days|Postoperative Response Evaluable Population|||percentage of participants||95% Confidence Interval|Number
1289886|NCT00127933|Secondary|Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))|The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.|post 2 and 4, 3-week cycles of treatment|Evaluable Population|||percentage of participants||95% Confidence Interval|Number
1289887|NCT00127933|Secondary|Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery|Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.|at the time of definitive surgery; after four 3-week cycles (3-4 months)|Pathological Response Evaluable Population|||percentage of participants||95% Confidence Interval|Number
1289888|NCT00127933|Primary|Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery|Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.|at the time of definitive surgery; after four 3-week cycles (3-4 months)|Pathological Response Evaluable Population|||percentage of participants||95% Confidence Interval|Number
1289889|NCT00127855|Secondary|Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose|Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to one month following administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the Booster Total Vaccinated Cohort.|||Subjects|||Number
1289890|NCT00127855|Secondary|Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course|Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to one month after the 3-dose primary vaccination course (Month 5)|The analysis was performed on the Total Vaccinated Cohort.|||Subjects|||Number
1289891|NCT00127855|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose|The analysis was performed on the Booster Total Vaccinated Cohort.|||Subjects|||Number
1289892|NCT00127855|Secondary|Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course|The analysis was performed on the Total Vaccinated Cohort.|||Subjects|||Number
1289893|NCT00127855|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).|During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose|The analysis was performed on the Booster Total Vaccinated Cohort, on subjects having completed the symptom sheet.|||Subjects|||Number
1289894|NCT00127855|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).|During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course|The analysis was performed on the Total Vaccinated Cohort, on subjects having completed the symptom sheet.|||Subjects|||Number
1289895|NCT00127855|Secondary|Anti-pneumococcal Antibody Concentrations|Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1297087|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 40||Baseline to Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1289896|NCT00127855|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values|Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
1289897|NCT00127855|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||Titer||95% Confidence Interval|Geometric Mean
1289898|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies|Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
1289899|NCT00127855|Secondary|Anti- HBs Antibody Concentrations|Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||Milli-International Units per Milliliter||95% Confidence Interval|Geometric Mean
1289900|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies|Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
1289901|NCT00127855|Secondary|Anti- PT Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
1289902|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies|Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
1289903|NCT00127855|Secondary|Anti-PRN Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
1289904|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies|Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
1289905|NCT00127855|Secondary|Anti- FHA Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
1289906|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies|Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
1289907|NCT00127855|Secondary|Anti-tetanus Antibody Concentrations|Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||International Units per Milliliter||95% Confidence Interval|Geometric Mean
1289908|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-tetanus Antibodies|Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
1289909|NCT00127855|Secondary|Anti-diphtheria Antibody Concentrations|Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||International Units per Milliliter||95% Confidence Interval|Geometric Mean
1289910|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-diphtheria Antibodies|Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
1289911|NCT00127855|Secondary|Anti-PRP Antibody Concentration|Concentrations are presented as GMCs and expressed as µg/mL.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1289912|NCT00127855|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
1289913|NCT00127855|Secondary|Anti-polysaccharide Y (PSY) Antibody Concentration|Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1289914|NCT00127855|Secondary|Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)|The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
1289915|NCT00127855|Secondary|Anti-polysaccharide C (PSC) Antibody Concentration|Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1289916|NCT00127855|Secondary|Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)|The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
1290008|NCT00126581|Secondary|Overall Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions"|Duration of Study (up to 3 years)||||percentage of participants||95% Confidence Interval|Number
1289917|NCT00127855|Secondary|Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers|Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Titer||95% Confidence Interval|Geometric Mean
1289918|NCT00127855|Secondary|Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
1289919|NCT00127855|Secondary|Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers|Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Titer||95% Confidence Interval|Geometric Mean
1289920|NCT00127855|Secondary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
1289921|NCT00127855|Primary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.|||Subjects|||Number
1289922|NCT00127855|Primary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.|||Subjects|||Number
1289923|NCT00127855|Primary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter|The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.|||Subjects|||Number
1289924|NCT00127842|Secondary|Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24|Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||percentage of participants||95% Confidence Interval|Number
1289925|NCT00127842|Secondary|Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)|The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||percentage of participants||95% Confidence Interval|Number
1290043|NCT00125957|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Median total depression symptoms rating at baseline and follow-up visits. The MADRS consists o 10 questions assessing depression symptoms. All questions are scored on a 0-6 severity scale, with 0 being absent and 4 being most severe. Total scores can range from 0-60.|Baseline and follow-up||||units on a scale||Full Range|Mean
1289926|NCT00127842|Secondary|Percent Change From Baseline to Month 24 in Patient Global Assessment|The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement.|Baseline and month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. Change was based on paired data.|||Percentage change||Full Range|Mean
1289927|NCT00127842|Secondary|Change From Baseline to Month 24 in Patient Global Assessment|The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||Units on a scale||Standard Deviation|Mean
1289928|NCT00127842|Secondary|Percent Change From Baseline to Month 24 in Physician Global Assessment|"The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites).~Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement."|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||Percentage change||Full Range|Mean
1289929|NCT00127842|Secondary|Change From Baseline to Month 24 in the Physician Global Assessment|The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.|Baseline and month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||Units on a scale||Standard Deviation|Mean
1289930|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module|"In the HLQ impediments to paid and unpaid labor module participants were asked Were you hindered by health problems at your paid work over the past two weeks? and answered according to the following: 'no not at all = 0', ‘yes, a little = 1’, ‘yes, very = 2’. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement."|Baseline and month 24|Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points.|||Units on a scale||Standard Deviation|Mean
1289931|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module|The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.|Baseline and month 24|"Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points (71 participants). n indicates the number of participants who had unpaid or paid help with their unpaid work."|||Hours||Standard Deviation|Mean
1289932|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module|"The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks.~Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement."|Baseline and Month 24|Full Analysis Set participants who completed the HLQ at Baseline and Month 24, were employed, and indicated they had some production losses due to health problems at work (participants with no production losses were not included).|||Hours||Standard Deviation|Mean
1290044|NCT00125931|Secondary|YMRS Scores|Assessment of current mania symptoms using YMRS. All questions have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean YMRS scores were reported, with the total ranging from 0-44. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.|Each morning of the three-day study||||units on a scale||Standard Deviation|Mean
1289933|NCT00127842|Secondary|Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module|The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.|Baseline and 24 months|Full Analysis Set participants who completed the HLQ at Baseline and Month 24, and were employed.|||days||Standard Deviation|Mean
1289934|NCT00127842|Primary|Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI|The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and 24 months|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||percentage of participants||95% Confidence Interval|Number
1289935|NCT00127803|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.||Day 0 to up to 70 days post-first vaccination|Safety assessments were on the safety population.|||Participants|||Number
1289936|NCT00127803|Primary|Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.||Day 0 and up to 7 days post each vaccination|Safety assessments were on the safety population.|||Participants|||Number
1289937|NCT00127803|Secondary|Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.|"Seroconversion was defined as a ≥4-fold increase in antibody levels from Baseline. For values below the limit of quantification (LLQ) for the assay, the LLQ was used.~Serum anti-toxin IgG levels were determined by enzyme linked immunosorbent assay (ELISA)."|Days 28, 56, 70, and 236 Post First Vaccination|Serum anti-toxin levels were assessed in the Fully Evaluable (Per-Protocol) Population.|||Participants|||Number
1289938|NCT00127790|Secondary|Depression Severity|Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.|Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)|participants who completed intervention and pre and post treatment assessments|||units on a scale||Standard Error|Mean
1289939|NCT00127790|Primary|IL-6|Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|Subjects completing blood draws to obtain plasma. One subject in the CBT-I&P condition did not complete blood draws.|||pg/mL||Standard Error|Mean
1289940|NCT00127790|Primary|Pain Severity|Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)||||units on a scale||Standard Error|Mean
1289941|NCT00127790|Primary|Insomnia Severity|Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|completed the intervention and self report instruments|||units on a scale||Standard Error|Mean
1289942|NCT00127712|Secondary|Length of Hospital Stay||Duration of hospitalization||||Days||Full Range|Median
1289943|NCT00127712|Primary|Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds||7 days||||Participants|||Number
1289944|NCT00127712|Secondary|Length of Intensive Care Unit Stay||Duration of hospitalization||||Hours||Full Range|Median
1289945|NCT00127712|Primary|Incidence of Atrial Fibrillation Requiring Treatment||7 days||||participants|||Number
1289946|NCT00127660|Primary|Energy Intake|energy content of meal ordered and consumed.|After meal||||kcal/meal||Standard Deviation|Mean
1289947|NCT00127660|Primary|Total Calories of Meal Ordered||single study visit|||||||
1289948|NCT00127530|Secondary|Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity||Days 14, 42, 70, 98|||||||
1289949|NCT00127530|Primary|Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)|Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.|Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.|ITT Population|||Participants|||Number
1289950|NCT00127439|Primary|Kinematics: Trunk Angle Mid-Stance|Trunk Angle Mid-Stance - position in degrees|12 weeks||||degrees||Standard Deviation|Mean
1289951|NCT00127439|Primary|Kinematics: Minimum Hip Angle - Extension|Hip angle at maximal hip extension during stepping|12 weeks||||degrees||Standard Deviation|Mean
1289952|NCT00127439|Primary|Kinematics: Minimum Thigh Angle|Greatest thigh angle for hip flexion during stepping|12 weeks||||degrees||Standard Deviation|Mean
1289953|NCT00127439|Primary|Propulsion: Propulsive Impulse|Push-off force at toe off in N-s during treadmill stepping|12 weeks||||N-s||Standard Deviation|Mean
1289954|NCT00127439|Primary|Foot Trajectory Range (Toe Off to Heel Strike)|Range of foot trajectory from toe off to heel strike in degrees. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control).|12 weeks||||degrees||Standard Deviation|Mean
1289955|NCT00127439|Primary|Foot Trajectory Initial Contact|Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees.|12 weeks||||degrees||Standard Deviation|Mean
1289956|NCT00127439|Primary|Stepping: Foot Trajectory Toe-off % Cycle|The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle.|12 weeks||||percentage of gait cycle||Standard Deviation|Mean
1289957|NCT00127439|Primary|Stepping: Foot Trajectory Toe-Off|Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps.|12 weeks||||degrees||Standard Deviation|Mean
1289958|NCT00127439|Primary|Self Selected Velocity on Treadmill|Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed.|12 weeks||||m/s||Standard Deviation|Mean
1289959|NCT00127413|Primary|Clinician Administered Assessment of PTSD|This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, & Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD.|Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up||||units on a scale||Standard Deviation|Mean
1289960|NCT00127231|Secondary|Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex|Number of days in the past 90 days on which participants reported having unprotected vaginal sex|Baseline to 12 month follow-up|Not all subjects participated in every follow-up interview.|||days||Standard Deviation|Mean
1289961|NCT00127231|Secondary|% of Patients Currently on Antiretroviral Therapy|number of participants who are currently receiving antiretroviral therapy/total number of participants|baseline through 1 year follow-up||||percentage of participants|||Number
1289962|NCT00127231|Secondary|HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)|the % of kept appointments out of scheduled appointments was determined for each participant, and then averaged for the set of participants at each time point|baseline through 1 year follow-up||||percentage of kept/scheduled appointment||Standard Deviation|Mean
1289963|NCT00127231|Primary|Number of Binge Drinking Days Out of the Past 90 Days|Number of days during the past 90 days on which women drank more than 3 standard drinks|Baseline through 12 month follow-up|Not all subjects participated in every follow-up interview.|||days out of past 90 days||Standard Deviation|Mean
1289964|NCT00127231|Primary|Number of Drinking Days Out of the Past 90 Days||Baseline through 1 year follow-up|All randomized participants were included in analyses although 6 participants from each arm did not complete the study due to loss to follow up|||days||Standard Deviation|Mean
1289965|NCT00127218|Secondary|Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization)|Cerebrovascular events (newly diagnosed) such as Stroke and Myocardial revascularization (specifically coronary artery bypass grafting, percutaneous coronary interventions, carotid endarterectomy) were recorded|18 months|Cardiovascular event (stroke) was seen in only 1 patient and 5 patients needed myocardial revascularization|||Participants|||Count of Participants
1289966|NCT00127218|Primary|Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries|The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.|18 months||||percentage of internal carotid artery||Standard Error|Mean
1289967|NCT00127192|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline at Week 12 is defined as Week 12 minus Week 0.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.|||mg/dL||95% Confidence Interval|Least Squares Mean
1289968|NCT00127192|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.|||Percent||95% Confidence Interval|Least Squares Mean
1289969|NCT00127192|Secondary|Change From Baseline in Glycosylated Albumin at Week 12|Change from baseline at Week 12 is defined as Week 12 minus Week 0.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.|||Percent||95% Confidence Interval|Least Squares Mean
1289970|NCT00127166|Secondary|Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percent change from baseline||95% Confidence Interval|Least Squares Mean
1289971|NCT00127166|Secondary|Time to Recovery to Within 5% of Baseline FEV1|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||minutes||Inter-Quartile Range|Median
1289972|NCT00127166|Secondary|Maximum FEV1 % Predicted Following First Beta-agonist Use|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percent of predicted value||95% Confidence Interval|Least Squares Mean
1289973|NCT00127166|Secondary|Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percent times Minutes||95% Confidence Interval|Least Squares Mean
1289974|NCT00127166|Primary|Maximum Post-exercise Percent (%) Fall in FEV1|The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The primary efficacy analysis was based on the full analysis set (FAS) population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percent change from baseline||95% Confidence Interval|Least Squares Mean
1289975|NCT00127101|Secondary|Number of Participants Who Responded to Treatment|"Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score.~SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400"|Every 28 days for up to 6 Months of Treatment|All patients treated|||Participants|||Number
1289976|NCT00127101|Primary|Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities|Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.|Day 1 to day 28|All Patients treated|||Participants|||Number
1289977|NCT00127036|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Review of Serious Adverse Events (SAEs) To assess the toxicity associated with Arms A and B. Response rates and toxicity rates for each arm were to be estimated and exact (using Casella’s method) 95% confidence intervals for those proportions computed. With the anticipated 75 patients in each arm, these estimated proportions would have standard errors not exceeding 7%.|30 Days After End of Treatment - Average of 6 Months|All participants.|||participants|||Number
1289978|NCT00127036|Secondary|Number of Participants Per Treatment Arm, With Overall Survival (OS)|Investigators planned to evaluate the overall survival of colorectal cancer (CRC) patients treated with XELOX + bevacizumab (Arm A) or XELIRI + bevacizumab (Arm B).|30 Days After End of Treatment - Average of 6 Months|Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.||||||
1289979|NCT00127036|Primary|Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier|Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease).|30 Days After End of Treatment - Average of 6 Months|Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.||||||
1289980|NCT00126776|Primary|Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)||1 yr||||events per year||95% Confidence Interval|Mean
1289981|NCT00126776|Secondary|All Cause Mortality||1 year|||||||
1289982|NCT00126776|Secondary|COPD Exacerbations Requiring Antibiotics or Corticosteroids||1 year|||||||
1289983|NCT00126776|Secondary|Quality of Life||1 year|||||||
1289984|NCT00126776|Secondary|All Cause Hospitalizations||1 year|||||||
1289985|NCT00126776|Primary|Hospitalization or Emergency Department Visit for COPD||1 yr|||||||
1290639|NCT00120250|Primary|Short PTSD Rating Interview (SPRINT)|The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.|8 weeks||||units on a scale||Standard Deviation|Mean
1289986|NCT00126750|Primary|Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators|The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level < previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level < previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (<8%).|1/1/02 - 12/31/08||||percentage of provider's patients|||Number
1289987|NCT00126737|Secondary|Stair Total (Climb, Descend)|Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.|Between Base-line and 24 Weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 1 in Weight Control Nutritional Program, 1 in Home-based exercise Program and 1 in Usual Care.|||Change in Steps||95% Confidence Interval|Mean
1289988|NCT00126737|Secondary|Walking Distance|Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 2 in Weight Control Nutritional Program.|||Change in Distance (m)||95% Confidence Interval|Mean
1289989|NCT00126737|Primary|Mental Scale SF-36v|The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program and 3 in Usual Care|||Change in Score||95% Confidence Interval|Mean
1289990|NCT00126737|Primary|Physical Scale SF-36v|The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 3 in the Usual Care.|||Change in score||95% Confidence Interval|Mean
1289991|NCT00126737|Primary|WOMAC Function|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 1 in Home-based exercise program and 1 in Usual Care.|||Change in Score||95% Confidence Interval|Mean
1289992|NCT00126659|Other Pre-specified|Time to Progression|Time, in weeks, after treatment until disease progresses. Repeat radiologic studies to evaluate disease progression or response after 10 weeks of BAY 43 9006 therapy.|Following 10 weeks of treatment or until disease progression|||||||
1289993|NCT00126659|Other Pre-specified|Overall Survival|The number of participants surviving from baseline (treatment) to death due to any cause measured in days.|Up to 2 years|||||||
1289994|NCT00126659|Other Pre-specified|Duration of Overall Response|Duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), measured in days.|Following 10 weeks of treatment, followed every 2 weeks or until disease progression|||||||
1289995|NCT00126659|Primary|Efficacy of BAY 43-9006 by Evaluating Response Rate|"Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: Disappearance all target lesions; Partial Response (PR): > 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): > 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease:~Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started."|Every 2 weeks during 4 week cycle|Unable to assess response due to small sample size.||||||
1290093|NCT00125190|Secondary|Bone Age - Change From Pretreatment Minus Change in Chronological Age Over the Study Period 0 - 86 Weeks [Intent to Treat Population]|Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.|Weeks 0 - 86|Subjects who had both baseline and week 86 measurements were included in the analysis.|||years||Standard Deviation|Mean
1289996|NCT00126594|Post-Hoc|Best Overall Response for Participants|Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response assignment will depend on the achievement of both measurement and confirmation criteria as defined by RECIST: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.|From the date response is confirmed to the date of disease progression, first assessed 2 months (8 weeks) following start of treatment and reassessed up to 36 months (on average reassessed 12 months or less).|All participants were included per intent to treat analysis.|||participants|||Number
1289997|NCT00126594|Secondary|Duration of Response for Participants With Stable Disease (N=37) Following Treatment|Duration of response for participants with disease stabilization following treatment as measured from the date response is confirmed to the date of disease progression, first assessed up to 8 weeks (2 cycles) following start of treatment. The duration of a Stable Disease (SD) response is measured from the time measurement criteria are met for that specific SD response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Repeat radiologic studies (CT, MRI, Chest x-ray and bone scan as indicated) to evaluate disease progression or response every 8 weeks.|From the date response is confirmed to the date of disease progression, up to 12 months|"Combined analysis reflects overall stable disease duration e.g. duration of benefit for stable disease cases without being affected by the median duration not attainable for the separate arms; 37 participants in the two arms met Stable Disease criteria: 17 in Sorafenib alone (Arm I) and 20 in the Sorafenib Plus Interferon group (Arm II)."|||Months||95% Confidence Interval|Median
1289998|NCT00126594|Secondary|Median Overall Survival (OS)|Overall survival defined as the time interval from the start of protocol therapy to death or date of last follow-up if alive.|From the start of protocol therapy to death or date of last follow-up, up to 36 months|Participants who die of unrelated cause during therapy or are lost to follow-up were censored. Median OS was not reached in Arm 1: Sorafenib as subjects experienced different events that made further follow-up impossible i.e. disease complications, death or lost to follow-up so overall survival data was not attainable.|||Months||95% Confidence Interval|Median
1289999|NCT00126594|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time interval from the start of protocol therapy to death or disease progression.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months|All participants were included per intent to treat analysis.|||Months||95% Confidence Interval|Median
1290000|NCT00126594|Secondary|Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events graded using the CTCAE version 4.0 tabulated by treatment arm within either toxicity grade for the treatment period. Treatment-related toxicity (acute and cumulative) performed every 8 weeks during the first year.|Up to 12 months of treatment|All participants were included in adverse event reporting per intent to treat analysis.|||participants|||Number
1290001|NCT00126594|Primary|Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)|ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.|Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.|Analysis performed for the intent-to-treat population.|||percentage of participants||95% Confidence Interval|Number
1290002|NCT00126581|Other Pre-specified|Overall Response Rate With KRAS Mutational Status|Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms.|Duration of study (up to 3 years)||||percentage of participants||95% Confidence Interval|Number
1290003|NCT00126581|Other Pre-specified|Progression Free Survival With KRAS Mutation Status|Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms.|Duration of study (up to 3 years)||||months||95% Confidence Interval|Median
1290004|NCT00126581|Other Pre-specified|Overall Response Rate by EGFR Mutation Status|Response and EGFR mutation status are defined in previous outcome measures.|Duration of study (up to 3 years)|EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.|||percentage of participants|||Number
1290005|NCT00126581|Other Pre-specified|Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status|"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.~EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and subjected to sequencing. The mutation analyses were blinded to the participants' clinical outcome."|Duration of treatment (up to 3 years)|EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.|||months||95% Confidence Interval|Median
1290006|NCT00126581|Other Pre-specified|Overall Survival|Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 3 years)||||months||95% Confidence Interval|Median
1290009|NCT00126581|Primary|18 Weeks Progression Free Survival (PFS) Rate|"The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm.~The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated."|At 18 weeks||||percentage of participants||95% Confidence Interval|Number
1290010|NCT00126568|Secondary|Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006|The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.|27 months|Any participant that received treatment was analyzed for adverse events. Detailed information is reported in the Adverse Events data table.|||Participants|||Count of Participants
1290011|NCT00126568|Secondary|Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.||27 months|All patients on study.|||months||95% Confidence Interval|Median
1290012|NCT00126568|Secondary|Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.||27 months|All patients on study|||months||95% Confidence Interval|Median
1290013|NCT00126568|Primary|Number of Patients With Response to Treatment Measured by RECIST Criteria|Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, x-ray) or as >10 mm with spiral CT scan.|at 6 months after treatment|All patients that received at least one cycle of treatment|||participants|||Number
1290014|NCT00126555|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3)|Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.|Up to 5 years|Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose & 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.|||participants|||Number
1290015|NCT00126555|Post-Hoc|Participant Treatment Following Induction Therapy|Treatment received following two 30-day cycles (60 days) of 250 mg gefitinib given by mouth daily. Participant treatment reported as percentage of total treated participants out of total treated.|Following 60 days of Gefitinib induction treatment||||percentage of participants|||Number
1290016|NCT00126555|Secondary|Change in Epidermal Growth Factor Receptor (EGFR) and Phospho-Akt Expression||From baseline to up to 30 days|||||||
1290017|NCT00126555|Secondary|Frequency and Timing of Local and Distant Failures||From study entry to first documented local recurrence or last patient contact, assessed up to 5 years|||||||
1290018|NCT00126555|Secondary|Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST)|Number participants with response defined by RECIST: Complete Response (CR): Disappearance all disease; No new lesions/non-evaluable disease; Responders on none/only maintenance doses of corticosteroids. Partial Response (PR): >/= 50% decrease under baseline in sum products perpendicular diameters of measurable lesions; No progression evaluable disease/new lesions; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Stable/No Response (SD): Not qualify for CR, PR, or progression; requires minimum 12 weeks duration; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Progression (PD): 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), OR clear worsening any evaluable disease, OR appearance any new lesion/site, OR failure to return due to death/deteriorating condition. All measurable/evaluable sites assessed using same baseline techniques.|Up to 5 years|One participant of 23 enrolled withdrew prior to treatment.|||participants|||Number
1290019|NCT00126555|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3)|Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.|Up to 5 years|Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose & 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.|||participants|||Number
1290020|NCT00126555|Primary|Feasibility Rate|Determined by the surgical healing time (resectable patients) and of concomitant gefitinib by treatment interruption during radiotherapy.|Up to 7 weeks|||||||
1290021|NCT00126555|Primary|Early Progression Rate|Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants restaged on days 15 and 60 of treatment.|Baseline to 60 days, up to 2 courses of induction therapy||||percentage of participants|||Number
1290105|NCT00125164|Secondary|Changes in Bone Age From Baseline to One Year|Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Year||Standard Deviation|Mean
1290022|NCT00126503|Primary|Objective Response|Objective response as determined by RECIST v. 1.0 (measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions)or last date known alive|Every 8 weeks to date of progression|Patients available for measurement of response to treatment with regimen. 7 Phase I and 4 Phase II patients were not available for measurement of response, respectively: disease progression (5, 2), complicating disease (1, 0), death on-study (1, 0), toxicity (0, 1), and alternative treatment (0, 1). All were counted as clinical progression.|||participants|||Number
1290023|NCT00126503|Primary|Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)|The highest dose in milligrams (mg) of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.|at 28 days|Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab|||mg/kg|||Number
1290024|NCT00126503|Secondary|Progression-free Survival|Duration of months of progression-free survival (PFS). Determined by months to progressive disease or to last date known alive without progressive disease.|on-study to date of progression or last date known alive without progression|All patients who underwent treatment. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.|||months||Full Range|Median
1290025|NCT00126503|Secondary|Overall Survival|Months from date on-study to expired or last date known alive|on-study to date of expired or last date known alive|All treated patients available for determination of overall survival. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.|||months||Full Range|Median
1290026|NCT00126503|Primary|Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.|at 28 days|Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab|||mg|||Number
1290027|NCT00126490|Secondary|Number of Participants With Possibly Related Serious Adverse Events (SAEs)|Number of Participants with Serious Adverse Events (SAEs) Possibly Related to Study Treatment. Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 30 days after completion of treatment|All Participants who received at least one treatment|||participants|||Number
1290028|NCT00126490|Secondary|Pearson Correlation Coefficients of Dendritic Cell (DC):Immature Cell (ImC) Ratio With DC Function|Dendritic cell (DC) phenotype or functionality. Pearson correlation coefficients of DC:ImC ratio with DC function were to be computed and tested for departure from zero. Those with major responses were to be compared to those without major responses with respect to baseline DC:ImC ratio, baseline DC functional assay, post-treatment DC:ImC ratio and post-treatment DC functional assay using pooled t tests.|At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment|This was not evaluable because there were not enough samples.||||||
1290029|NCT00126490|Secondary|Number of Evaluable Participants With Progression Free Survival (PFS)|Progression Free Survival tabulation at 1 year and at 2 years. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 2 years|Evaluable participants|||participants|||Number
1290030|NCT00126490|Secondary|Number of Evaluable Participants With Overall Survival (OS) at 2 Years|Overall Survival tabulation at 2 years from start of treatment.|2 years from start of treatment|Evaluable participants|||participants|||Number
1290031|NCT00126490|Primary|Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year|Major response according to Response Evaluation Criteria In Solid Tumors (RECIST). CR: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|1 year|All Participants who received at least one treatment|||participants|||Number
1290032|NCT00126438|Primary|Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events. Data analysis to assess the relative hazard of an adverse cardiac event was performed only on HF participants categorized into 2 groups with H/M <1.6 and H/M ≥1.6 using a Cox proportional hazards model.|Approximately 24 months from the date of administration of 123I-mIBG|Primary efficacy population included 444 participants in HF group who received IMP and had a diagnostic (optimal/sub-optimal) 3 hour 50 minute planar image. Primary efficacy analysis was based on comparing only “Adreview HF” participants with low vs. high H/M and, therefore, did not include “Adreview Control” group.|||number of adverse cardiac events|||Number
1290143|NCT00124982|Secondary|Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|BL|All treated participants|||units on a scale||Standard Deviation|Mean
1290033|NCT00126425|Primary|Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as ‘Low’ and ‘High’ based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events.|Approximately 24 months from the date of administration of 123I-mIBG|Primary efficacy population was 520 participants in HF group who received IMP and had a diagnostic (optimal or sub-optimal) 3 hour 50 minute planar image. Images from 2 HF participants were inadvertently not submitted and not presented to blinded readers. Here, N=efficacy population and n=number of participants assessed by specific readers.|||number of adverse cardiac events|||Number
1290034|NCT00126191|Secondary|Disease Free Survival|Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.|Until disease progression up to 120 months|One low-risk participant was lost to follow-up after 48 months of disease free survival.|||Months||Full Range|Mean
1290035|NCT00126191|Primary|Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt|"Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed.~Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable.~Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment."|3 years||||participants|||Number
1290036|NCT00126126|Secondary|Six-minute Walk Test|The six-minute walk test (6MWT) is a measure of overall functional mobility, and cardiopulmonary and musculoskeletal endurance. It assesses the distance ambulated in 6 minutes. The 6MWT has excellent reliability for lower limb amputees and can differentiate between amputee Medicare Functional Classification Levels (MFCL).Lower limb amputees functioning at the K2 level ambulate a mean distance of 200 meters. Those at the K3 level ambulate a mean distance of 300 meters. Those at the K4 level ambulate a mean distance of 400 meters. Service Members with traumatic lower limb loss ambulate a distance of 600 meters. The minimal detectable change for the 6MWT is 45 meters.|8 weeks for intervention and wait list control group|Repeated Measures ANOVA|||meters||Standard Deviation|Mean
1290037|NCT00126126|Primary|Amputee Mobility Predictor|The Amputee Mobility Predictor is a reliable and valid performance-based outcome measure of prosthetic mobility. The AMP is scored from 0-47, higher scores indicating greater prosthetic mobility. The AMP can help clinicians differentiate between different functional K-levels based on as defined by the Medicare Functional Classification Level (MFCL) system. Lower limb amputees functioning at the K2 level score between 27-36 on the AMP and are classified as limited community ambulators. Those at the K3 level score between 37-42 and are typical community ambulators who have the ability to traverse environmental barriers and performing activities that are beyond simple locomotion. Individuals at the K4 level score between 43-47 which is typical of prosthetic demands of an active adult or regular athlete. The minimal detectable change for the AMP is 3.4 points.|8 weeks for intervention and for wait-list control|Repeated Measures ANOVA|||Points||Standard Deviation|Mean
1290038|NCT00126113|Secondary|International Outcome Inventory for Hearing Aids (IOI-HA)|The IOI-HA is a seven-item questionnaire for which hearing-aid use, hearing-aid benefit, residual activity limitation, hearing-aid satisfaction, residual participation restriction, impact on others, and quality of life are rated on a five-point scale. An overall IOI-HA score is generated by averaging responses to all seven items. Higher scores reflect better self-reported outcome. Scores can range from 7 (poorest outcome) to 35 (best outcome).|Day 70 (end of study)||||units on a scale||Standard Deviation|Mean
1290039|NCT00126113|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|APHAB: The APHAB is a 24-item questionnaire that documents hearing difficulties in specified listening situations. Items are answered on a seven-point scale from ‘ Always ’ to ‘ Never ’ with higher scores indicating greater reported hearing disability. The questionnaire has four subscales: Ease of communication, Reverberation, Background noise, and Aversiveness, from which a global score is computed by averaging the Ease of communication, Reverberation, and Background noise scale scores. Questions are answered for unaided and aided listening. By subtracting aided scores from unaided scores a measure of reported aided benefit is obtained. Scores can range from 0 (no disability) to 99 (maximum disability).|Day 70 (end of study)||||units on a scale||Standard Deviation|Mean
1290040|NCT00126113|Secondary|Hearing Handicap Inventory (HHI)|HHI: The HHI for the elderly is for individuals over age 65 years; the HHI for adults is for individuals aged 65 years and younger. Both are 25-item questionnaires that assess the social and emotional consequences of hearing loss. The versions differ in the wording of three questions. Items are answered on a scale of Yes (4 points), Sometimes (2 points), and No (0 points) with higher scores indicating greater reported hearing handicap. Scores can range from 0 (no handicap) to 100 (maximum handicap).|Day 70 (end of study)||||units on a scale||Standard Deviation|Mean
1290041|NCT00126113|Primary|Psychosocial Impact of Assistive Devices Scale (PIADS)|PIADS: The PIADS measures the psychosocial impact of any assistive device(s). Here that is a hearing aid. The PIADS is a 26-item self-rating scale. The user rates each item on a seven-point scale that ranges from negative 3 (maximum negative impact) to positive 3 (maximum positive impact). The midpoint, zero, indicates no impact or no perceived change resulting from device use. It measures three quality-of-life domains: (1) Adaptability that reflects the inclination or motivation to participate socially and take risks; (2) Competence that reflects perceived functional capability, independence, and performance; and (3) Self-esteem that reflects self-confidence, self esteem, and emotional well-being.|Day 70 (end of study) only||||units on a scale||Standard Deviation|Mean
1290042|NCT00125957|Primary|Hamilton Depression Rating Scale (HAM-D)|Median total depression ratings at baseline and follow-up using the HAM-D. The scale consists of 21 questions that assess depression symptoms. Questions 1-3, 7-11, 15, and 19 are rated on a scale of 0-4, with 0 being not present to and 4 being severe. Questions 4, 5, 12 - 14, 16-18 and 21 are rated from 0-2 with a score of 0 signifying the symptom is absent and a score of 2 as most severe. Item 20 is score on a scale of 0-3 with the same pattern of severity as all other questions. The total score for the HAM-D ranges from 0-63.|Baseline and follow-up||||units on a scale||Full Range|Median
1290640|NCT00120042|Secondary|Endometrial Appearances Postpartum||3 years|||||||
1290045|NCT00125931|Primary|Mania Symptoms Using MACS|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.|hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered||||units on a scale||Full Range|Mean
1290046|NCT00125762|Primary|Diagnostic Accuracy of VCTE for the Prediction of Metavir Fibrosis Scores by Differentiating no/Mild (F0/F1) From Severe Fibrosis (F2 - F4)|95% CI for Metavir Fibrosis stage 0 -1 consistent with no or mild fibrosis compared to Metavir 2 - 4 which represents significant fibrosis or cirrhosis|Liver Biopsy and VCTE within a time frame of 6 months|456 patients with matching liver biopsy and fibroscan|||ROC area||95% Confidence Interval|Mean
1290047|NCT00125762|Primary|Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)|VCTE was used to diagnose cirrhosis F4 in 748 patients undergoing liver biopsy and VCTE within a 28 day time period.|28 days|748 patients were eligible for analysis with matching valid liver biopsies and VCTE measurements.|||ROC area||95% Confidence Interval|Mean
1290048|NCT00125658|Secondary|Movement Smoothness|"Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or jerky movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline."|baseline, 10 weeks, 20 weeks||||sub movements||Standard Deviation|Mean
1290049|NCT00125658|Secondary|Movement Accuracy (Reach Path Ratio, RPR)|Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||ratio||Standard Deviation|Mean
1290050|NCT00125658|Primary|Upper-extremity Fugl-Meyer Motor Assessment|The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||units on a scale||Standard Deviation|Mean
1290051|NCT00125658|Secondary|Movement Speed|peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||cm/s||Standard Deviation|Mean
1290052|NCT00125658|Primary|Change in Elbow Extension Range of Motion|joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||degrees||Standard Deviation|Mean
1290053|NCT00125658|Primary|Change in Shoulder Flexion|joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||degrees||Standard Deviation|Mean
1290054|NCT00125658|Primary|Change in Trunk Displacement|Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||centimeters||Standard Deviation|Mean
1290055|NCT00125619|Secondary|Berg Balance Scale|Clinical measure of balance|4 weeks||||units on a scale||Standard Deviation|Mean
1290056|NCT00125619|Secondary|Short Physical Performance Battery|Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.|4 weeks||||units on a scale||Standard Deviation|Mean
1290057|NCT00125619|Secondary|Lower Extremity Fugl-Meyer Motor Assessment|Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.|4 weeks||||units on a scale||Standard Deviation|Mean
1290058|NCT00125619|Secondary|Step Length Ratio (Abs)|measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]|4 weeks||||ratio||Standard Deviation|Mean
1290059|NCT00125619|Secondary|Six Minute Walk|distance, in meters, walked overground over a six minute interval.|4 weeks||||meters||Standard Deviation|Mean
1290060|NCT00125619|Secondary|Fast Walking Speed|Fastest comfortable walking speed measured while walking overground|4 weeks (s/p 12 training sessions)||||meters/s||Standard Deviation|Mean
1290061|NCT00125619|Primary|Self-selected Overground Walking Speed|Overground walking speed determined as rate of walking over a 10 meter distance.|4 weeks (s/p 12 sessions of locomotor training)||||meters/s||Standard Deviation|Mean
1290062|NCT00125593|Secondary|End-stage Renal Disease Among All Patients Not on Dialysis at the Time of Randomization to Simvastatin Plus Ezetimibe Versus Placebo|End-stage renal disease was defined as initiation of maintenance dialysis or renal transplantation. Temporary dialysis was excluded. All potential dialysis and transplant events were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
1290166|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.|BL, Day 169|All treated participants|||IU/mL||Standard Deviation|Mean
1290063|NCT00125593|Secondary|Coronary or Non-coronary Revascularization Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Revascularization included any arterial revascularization procedure, whether surgical or percutaneous, but excluded revascularization performed for hemodialysis vascular access (e.g. fistuloplasty) or to the donor kidney transplant artery. Revascularization included amputations for vascular disease (rather than for trauma or infection). All potential revascularization events (including angiography) were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
1290064|NCT00125593|Secondary|Non-hemorrhagic Stroke Among All of Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Stroke was defined as rapid onset of focal or global neurological deficit, with duration greater than 24 hours. Clinical notes and brain imaging were sought to determine the stroke etiology, and if the stroke was fatal and post-mortem examination findings were available, this information was also assessed. All potential stroke events (including transient ischemic attack and intracerebral hemorrhage) were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
1290065|NCT00125593|Secondary|Major Coronary Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major coronary events defined as coronary death or non-fatal myocardial infarction. Myocardial infarction adjudicated based on the presence of serial changes in cardiac biomarkers (e.g. troponin, creatine kinase), typical ECG changes and typical cardiac symptoms. If myocardial infarction was fatal and post-mortem examination findings were available, this information was also assessed. All potential coronary events were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
1290066|NCT00125593|Secondary|Major Vascular Events Analyzed Amongst Patients Initially Randomized to Simvastatin Plus Ezetimibe Versus Placebo (Original Protocol-defined Primary Outcome)|Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years|Includes only those patients initially randomized to simvastatin plus ezetimibe versus placebo (as opposed to all patients ever randomized to simvastatin plus ezetimibe versus all patients allocated placebo)|||participants|||Number
1290067|NCT00125593|Secondary|Major Vascular Events Analyzed Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
1290068|NCT00125593|Primary|Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major atherosclerotic events defined as non-fatal myocardial infarction or coronary death, non-hemorrhagic stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
1290069|NCT00125528|Secondary|McGill Pain Questionnaire (MPQ)|Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.|6 weeks||||units on a scale||Standard Deviation|Mean
1290070|NCT00125528|Primary|Change in Numeric Rating Scale (NRS-11)|Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.|6 weeks||||units on a scale||Standard Deviation|Mean
1290071|NCT00125515|Primary|Retention in Treatment|The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.|Number of participants who complete 12 weeks of treatment|All analysis were conducted based on intent-to-treat principle.|||participants|||Number
1290072|NCT00125372|Secondary|Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response||Baseline and 9 days|The numbers analyzed are represented in the rows by EGFR status at baseline. Eight participants had wild-type EGFR at baseline, one had a mutation at Exon 21, and one participant's EGFR status was not assessed at baseline. The total of all rows matches the overall number analyzed; 10.|||Participants|||Count of Participants
1290073|NCT00125372|Secondary|Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels||At 9 days|The testing necessary to determine the correlation documented in this outcome was not performed due to budget constraints.||||||
1290074|NCT00125372|Primary|Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)||Baseline and 9 days||||Participants|||Count of Participants
1290075|NCT00125372|Primary|Number of Participants With Change in Expression Level of Cyclin D1||Baseline and 9 days||||Participants|||Count of Participants
1290076|NCT00125372|Primary|Number of Participants With Change in Expression Level of EGFR.||Baseline and 9 dyas||||Participants|||Count of Participants
1290077|NCT00125359|Secondary|Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses.||Through study completion, an average of 1 year|Three patients had biopsies evaluated for EGFR mutations.|||Participants|||Count of Participants
1290078|NCT00125359|Secondary|Progression-free Survival and Overall Survival||Through study completion, an average of 1 year||||Weeks||Full Range|Median
1290167|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.|BL, Day 169|All treated participants|||mg/dL||Standard Deviation|Mean
1290079|NCT00125359|Secondary|Correlation of Early PET Responses With Objective Radiographic Responses.|PET response is assessed based on the guidelines of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group (Eur J Cancer 1999; 35(13):1773-82). Radiographic response is per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Through study completion, an average of 1 year|Number of participants analyzed is reported per achieved disease response noted in individual rows.|||Participants|||Count of Participants
1290080|NCT00125359|Primary|Radiographic Response Rates|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Through study completion, an average of 1 year||||Participants|||Count of Participants
1290081|NCT00125268|Secondary|Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment|The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.|baseline, 4 weeks|||||||
1290082|NCT00125268|Secondary|Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment|The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.|baseline, 4 weeks|||||||
1290083|NCT00125268|Primary|Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment|Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.|baseline, 4 weeks|||||||
1290084|NCT00125242|Primary|Word Retrieval Accuracy|"Accuracy of naming of pictured treated and untreated items was assessed in probes conducted separate from treatment. Probes were conducted repeatedly throughout the study, from baseline (prior to treatment) to follow-up (6 weeks following treatment). All naming responses were scored using a 0-10 scale reflecting promptness and presence of errors; scores of 8-10 received an accuate score and scores of 0-7 received an inaccurate score. A percentage accuracy score was calculated for each experimental set of items for every probe session. Baseline probe scores were compared to end of treatment and follow-up probe scores to obtain individual effect sizes for each experimental list of items for each participant (i.e., several effect sizes were calculated for each participant). All effect sizes were utlized to obtain an average effect size for each participant; these averages were then utlized to obtain a group average."|End of treatment and at 6 weeks post treatment|SFA Treatment Participants were stroke-survivors with chronic aphasia who had significant word retrieval difficulties. Non Treatment Stimuli Development Participants were only enrolled in the study to provide data for the development of treatment stimuli. As such, they were not assessed for the outcome measure.|||d-index (effect size)|Participants|Standard Deviation|Mean
1290085|NCT00125190|Post-Hoc|Increase in Height Velocity Over the Study Period 34 - 86 Weeks [Completers]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 34 - 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects completing Week 86 were included in the analysis.|||cm/yr||Standard Deviation|Mean
1290086|NCT00125190|Post-Hoc|Increase in Height Velocity Over the Study Period 0 - 34 Weeks [Completers]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 0 -34|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects completing Week 34 were included in the analysis.|||cm/yr||Standard Deviation|Mean
1290087|NCT00125190|Secondary|rhIGF-1 Doses Required to Achieve the Serum IGF-1 Targets With Measures Taken at Each Study Visit||34, 52 and 86 weeks|||||||
1290088|NCT00125190|Secondary|Percent Changes in Serum Concentration of Acid Labile Subunit (ALS) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of Serum Concentration of Acid Labile Subunit (ALS).|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.|||percent||Full Range|Median
1290089|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-3 (IGFBP-3) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.|||percent||Full Range|Median
1290090|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-2 (IGFBP-2) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-2 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.|||percent||Full Range|Median
1290091|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-1 (IGFBP-1) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-1 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 34 measurements were included in the analysis.|||percent||Full Range|Median
1290092|NCT00125190|Primary|Height Velocity Over the Study Period 34 - 86 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 34 to 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects continuing past Week 34 were included in the analysis.|||cm/yr||Standard Deviation|Mean
1290094|NCT00125190|Secondary|Changes in Height Standard Deviation (SD) Score Over the Study Period 34 - 86 Weeks|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Weeks 34 - 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects continuing past Week 34 were included in the analysis.|||SDs||Standard Deviation|Mean
1290095|NCT00125190|Secondary|Changes in Height Standard Deviation (SD) Score Over the Study Period 0 - 34 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Weeks 0 - 34|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score.|||SDs||Standard Deviation|Mean
1290096|NCT00125190|Primary|Height Velocity Over the Study Period 0 - 34 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|34 weeks|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score.|||cm/yr||Standard Deviation|Mean
1290097|NCT00125164|Post-Hoc|Change From Baseline in Height Standard Deviation (SD) Score at One Year - Completers|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|One Year|All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||SD/year||Standard Deviation|Mean
1290098|NCT00125164|Post-Hoc|Height Velocity During the First Year for Subjects - Completers|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|One Year|All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||cm/year||Standard Deviation|Mean
1290099|NCT00125164|Secondary|IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)|Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.|Study Day 1 and Day 7|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||mg/dL||Standard Deviation|Mean
1290100|NCT00125164|Secondary|IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)|Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.|Study Day 1 and Day 7|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||ng/mL||Standard Deviation|Mean
1290101|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Percent change||Standard Deviation|Mean
1290102|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year|Blood sample was collected for measuring the level of insulin-like growth factor binding protein-2 (IGFBP-2) in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Percent change||Standard Deviation|Mean
1290103|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year|Blood sample was collected for measuring the level of IGF-2 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Percent change||Standard Deviation|Mean
1290104|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year|Blood sample was collected while subject is in a fasting state for measuring the level of IGF-1 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Percent change||Standard Deviation|Mean
1290209|NCT00124735|Primary|Total Dose of Zemuron (Rocuronium) Administered|Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol [PP] data set)|during surgery|Per protocol population|||mg/kg||Standard Deviation|Mean
1290106|NCT00125164|Secondary|Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Measured at baseline and at one year|A modified intention-to-treat population that consists of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||SD/year||Standard Deviation|Mean
1290107|NCT00125164|Primary|Height Velocity During the First Year - Intent to Treat (ITT)Population|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Measured at baseline and at one year|A modified intention-to-treat population consisting of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||cm/yr||Standard Deviation|Mean
1290108|NCT00125138|Secondary|Investigator/Caregiver Evaluations of Motor Function|The change in the motor section of the Unified Parkinson’s Disease Rating Scale (UPDRS III - motor exam) score. Scores on the UPDRS III - motor exam range from 0 to 108, with higher scores indicating more severe motor symptoms.|6 weeks (from Baseline to end of Maintenance Period)|All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.|||Scores on a scale||Standard Deviation|Mean
1290109|NCT00125138|Primary|Patient Evaluation of Symptoms of Psychosis.|The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.|6 weeks (from Baseline to end of Maintenance Period)|All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.|||Scores on a scale||Standard Error|Least Squares Mean
1290110|NCT00125034|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008|Safety Population|||participants|||Number
1290111|NCT00125034|Secondary|Duration of Response|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||months||95% Confidence Interval|Median
1290112|NCT00125034|Secondary|Disease Control Rate (Cut Off Date 4 August 2006)|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments as assessed by IRC (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||percentage of participants||95% Confidence Interval|Number
1290113|NCT00125034|Secondary|Participants With No Residual Tumor After Metastatic Surgery|No residual tumor after on-study surgery for metastases.|Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||participants|||Number
1290114|NCT00125034|Secondary|Overall Survival Time (KRAS Mutant Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|KRAS Mutant population|||months||95% Confidence Interval|Median
1290115|NCT00125034|Secondary|Overall Survival Time (KRAS Wild-Type Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|KRAS Wild-Type population|||months||95% Confidence Interval|Median
1290116|NCT00125034|Secondary|Overall Survival Time|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||months||95% Confidence Interval|Median
1290117|NCT00125034|Secondary|Progression-free Survival Time (KRAS Mutant Population)|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|KRAS Mutant population|||months||95% Confidence Interval|Median
1290118|NCT00125034|Secondary|Progression-free Survival Time (KRAS Wild-Type Population)|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|KRAS Wild-Type population|||months||95% Confidence Interval|Median
1290119|NCT00125034|Secondary|Progression-free Survival Time|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||months||95% Confidence Interval|Median
1290120|NCT00125034|Secondary|Best Overall Response Rate (KRAS Mutant Population)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007|KRAS Mutant population|||percentage of participants||95% Confidence Interval|Number
1290121|NCT00125034|Secondary|Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007|KRAS Wild-Type population|||percentage of participants||95% Confidence Interval|Number
1290122|NCT00125034|Primary|Best Overall Response Rate - Independent Review Committee (IRC)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006|Primary analysis on the Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||percentage of participants||95% Confidence Interval|Number
1290123|NCT00124982|Secondary|LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1-813|Treated participants with available serum samples for assay|||participants|||Number
1290124|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.|BL (Day 0), Days 365, 729|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Error|Mean
1290125|NCT00124982|Secondary|Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term|SF-36 measures health-related quality of life and has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.|Days 365 and 729|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
1290126|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health;(2) mental component summary=vitality,social functioning,role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit|BL (Day 0)|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
1290194|NCT00124748|Secondary|Estimated Rate of Overall Survival (OS) in Two Treatment Arms|OS was defined as time between randomization and death due to any cause during study treatment or during follow-up after discontinuation of treatment. Estimated rate of OS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
1290127|NCT00124982|Secondary|Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time|HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|BL, Days 365, 449, 533, 617, 729, 813|All treated participants. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements.|||participants|||Number
1290128|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Error|Mean
1290129|NCT00124982|Secondary|Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term|HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.|Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
1290130|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0)|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
1290131|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Error|Mean
1290132|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
1290133|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||mg/dL||Standard Error|Mean
1290193|NCT00124748|Secondary|Kaplan-Meier Estimates of Duration of First Major Molecular Response Until Confirmed Loss|Duration of MMR (months) = (date of first confirmed loss or censoring - date of MMR + 1 ) / 30.4375. Estimated rate of duration of first MMR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|From First major molecular response to first confirmed loss or censoring|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
1290134|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||mg/dL||Standard Deviation|Mean
1290135|NCT00124982|Secondary|Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term|The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||swollen joints||Standard Error|Mean
1290136|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term|The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||swollen joints||Standard Deviation|Mean
1290137|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term|The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||tender joints||Standard Error|Mean
1290138|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term|The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||tender joints||Standard Deviation|Mean
1290139|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Error|Mean
1290140|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
1290141|NCT00124982|Secondary|Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|BL, Days 365, 449, 533, 617, 729, 813|All treated participants. n=number of evaluable participants.|||participants|||Number
1290142|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|BL, Day 169|All treated participants|||units on a scale||Standard Deviation|Mean
1290641|NCT00120042|Secondary|Post-Delivery Blood Loss|Blood loss was assessed by weighing of pads and sheets in addition to clot|3 years||||mls||Inter-Quartile Range|Median
1290144|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|BL, Day 169|All treated participants. n=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1290145|NCT00124982|Primary|Long-term Period: Mean Temperature (T) Over Time||From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable temperature readings.|||degrees Celsius||Standard Deviation|Mean
1290146|NCT00124982|Primary|Long-term Period: Mean Heart Rate (HR) Over Time||From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable heart rate readings.|||beats per minute||Standard Deviation|Mean
1290147|NCT00124982|Primary|Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time|Measurements were taken in a seated position before and after abatacept infusion.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable blood pressure readings.|||mm Hg||Standard Deviation|Mean
1290148|NCT00124982|Primary|Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time|Measurements were taken in a seated position before and after abatacept infusion.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable blood pressure measurements.|||mm Hg||Standard Deviation|Mean
1290149|NCT00124982|Primary|LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time|Na NR=132 – 147 mEq/L, MA is 95* LLN/ >1.05* ULN, or if BL<LLN then use 0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN. K NR=3.3 – 5.5 mEq/L, MA is <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN. Cl NR=94 – 111 mEq/L, MA is <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||mEq/L||Standard Deviation|Mean
1290150|NCT00124982|Primary|Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time|Bilirubin NR=0.2–1.2 mg/dL, MA: >2* ULN, or if BL>ULN then use >4* BL. BUN NR=4.0–24.0 mg/dL, MA: >2*BL. Creatinine NR=0.4–1.2 mg/dL, MA: >1.5*BL. Ca NR=8.8–10.2 mg/dL, MA: <0.8*LLN/>1.2*ULN, or if BL<LLN then use 0.75*BL or >ULN, or if BL>ULN then use>1.25*BL or <LLN. P NR=2.8–4.0 mg/dL, MA: <0.75*LLN/ >1.25*ULN, or if BL<LLN then use 0.67*BL or >ULN, or if BL>ULN then use>1.33*BL or <LLN. Glu MA: <65 mg/dL/ >220 mg/dL. Uric acid MA: >1.5*ULN, or if BL>ULN then use >2*BL.|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||mg/dL||Standard Deviation|Mean
1290151|NCT00124982|Primary|Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time|HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||U/L||Standard Deviation|Mean
1290152|NCT00124982|Primary|Long-term Period: Change From Baseline in White Blood Cells Over Time|Leukocytes NR=4.1 - 12.3*10^3 c/uL, MA is <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN. Neutrophils+bands MA is <1.0 * 10^3 c/uL. Eosinophils MA is >0.750 * 10^3 c/uL. Basophils MA is > 400 mm^3. Monocytes MA is >2000 mm^3. Lymphocytes MA is <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||10^3 c/uL||Standard Deviation|Mean
1290153|NCT00124982|Primary|Long-term Period: Change From Baseline in Platelets (PLT) Over Time|Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||10^9 c/L||Standard Deviation|Mean
1290154|NCT00124982|Primary|Long-term Period: Change From Baseline in Erythrocytes Over Time|Erythrocytes NR= 3.80 – 5.50 *10^6 c/uL, MA is <0.75 * BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||10^6 c/uL||Standard Deviation|Mean
1290155|NCT00124982|Primary|Long-term Period: Change From Baseline in Hematocrit Over Time|The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||percentage change||Standard Deviation|Mean
1290156|NCT00124982|Primary|Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time|HGB normal range (NR)=11.6 – 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 – 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 – 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||g/dL||Standard Deviation|Mean
1290192|NCT00124748|Secondary|Kaplan-Meier Estimates of Duration of First Complete Cytogenetic Response (CCyR)|Duration of CCyR was defined as the time between date of CCyR and the earliest of either (1) loss of CCyR OR (2) (Chronic Myeloid Leukemia) CML-related death or progression to (Accelerated Phase/Blast Crisis) AP/BC during study treatment. Estimated rate of duration of first CCyR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|From first complete cytogenetic response to first confirmed loss or censoring|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
1290157|NCT00124982|Primary|Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria|Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
1290158|NCT00124982|Primary|Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria|Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
1290159|NCT00124982|Primary|Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase (GGT): >2*ULN, or if BL>ULN, use >3*BL; bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen (BUN): >2*BL; creatinine: >1.5*BL|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
1290160|NCT00124982|Primary|Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Marked abnormality criteria=Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes:<0.75*BL; Platelets: <0.67*LLN/>1.5 * ULN, or if BL<LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN,use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|Participants who received at least 1 infusion of abatacept during the long-term treatment period. n=number of participants with evaluable laboratory results.|||participants|||Number
1290161|NCT00124982|Primary|Long-term Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants|||participants|||Number
1290162|NCT00124982|Primary|Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants|||participants|||Number
1290163|NCT00124982|Secondary|Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|BL|All treated participants. n=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1290164|NCT00124982|Secondary|Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response|HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|BL, Day 169|All treated participants|||participants|||Number
1290165|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).|BL, Day 169|All treated participants|||units on a scale||Standard Deviation|Mean
1290168|NCT00124982|Secondary|Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|All treated participants. n=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1290169|NCT00124982|Secondary|Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|All treated participants. n=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1290170|NCT00124982|Primary|Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1-169|Treated participants with available serum samples for assay|||participants|||Number
1290171|NCT00124982|Primary|Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure||Day 1 (Baseline) -Day 169|Although mean values for systolic and diastolic blood pressure were recorded, mean changes from baseline were not summarized for these data.|||mm Hg||Standard Deviation|Mean
1290172|NCT00124982|Primary|Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria|Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
1290173|NCT00124982|Primary|Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria|Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
1290174|NCT00124982|Primary|Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
1290175|NCT00124982|Primary|Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Days 1-169|Participants who received at least 1 infusion of abatacept during the short-term treatment period|||participants|||Number
1290176|NCT00124982|Secondary|Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|BL, Day 169|All treated participants.|||participants|||Number
1290177|NCT00124982|Primary|Short-term Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Days 1-169|All treated participants|||participants|||Number
1290207|NCT00124735|Secondary|Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%|The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population|||minutes||Standard Deviation|Mean
1290178|NCT00124982|Primary|Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|Days 1-169|All treated participants|||participants|||Number
1290179|NCT00124943|Secondary|Percentage of In-Stent Volume Obstruction at 6 Months|In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume * 100.|6 months|Treated population for whom data was available.|||Percentage of obstruction||Standard Deviation|Mean
1290180|NCT00124943|Secondary|Late Lumen Loss|"Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography.~Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up."|Day 0 (post-procedure baseline) and 6 months.|"Treated population for whom data was available (indicated by n)."|||mm||Standard Deviation|Mean
1290181|NCT00124943|Primary|Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months|Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.|From the day of Percutaneous Coronary Intervention to Month 6.|Treated population.|||participants|||Number
1290182|NCT00124943|Primary|Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month|Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.|From the day of Percutaneous Coronary Intervention to 1 Month.|Treated population.|||participants|||Number
1290183|NCT00124943|Secondary|Percentage of Participants With Binary Restenosis|Binary restenosis was assessed by quantitative coronary angiography and defined as >50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory.|6 months|Treated Population.|||percentage of participants|||Number
1290184|NCT00124943|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|"An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.~An SAE is any event that:~is fatal or life threatening~results in persistent or significant disability or or incapacity;~requires or prolongs existing hospitalization;~is a congenital anomaly/birth defect in the offspring of a patient who received medication;~conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above."|Up to 6 months.|Treated population.|||participants|||Number
1290185|NCT00124943|Primary|Number of Participants With Procedural Complications|"Procedural complications include the following:~Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes;~Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia;~Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema;~Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow;~Clinical changes: chest pain."|From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).|Treated population.|||participants|||Number
1290186|NCT00124943|Primary|Phase I: Number of Participants With Dose-limiting Toxicities|"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting.~The maximum tolerated dose was defined as the lesser of 45 mg/m^2 or the dose at which any drug related toxicities were observed."|Up to 1 week following percutaneous coronary intervention.|Phase I treated population.|||participants|||Number
1290187|NCT00124748|Secondary|Number of Participants With the Effect of Imatinib on the Diabetic Participants With Known Concomitant Type II Diabetes||12 months|Due to the small number of diabetic patients enrolled into the study, the analysis was never done.|||Participants|||Number
1290188|NCT00124748|Secondary|Time to First Complete Molecular Response (CMR)]|Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene.|48 months overall|This analysis was not done because no major molecular improvement was observed in the 800mg dose compared to 400mg dose. Hence, analysis for complete molecular response was not necessary.|||Months||95% Confidence Interval|Median
1290189|NCT00124748|Secondary|Estimated Rates of Progression Free Survival (PFS) on Treatment by Major Molecular Response (MMR)|A Landmark Kaplan-Meier analysis was performed for PFS at 42 months by MMR status at 6, 12, and 18 months to investigate their prognostic value.|42 months|Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment. Patients without a valid polymerase chain reaction (PCR) assessment or those who had experienced an event before the landmark were excluded from analysis|||Percent probability||95% Confidence Interval|Number
1290190|NCT00124748|Secondary|Imatinib Pharmacokinetic Trough Plasma Concentration (Cmin) at Month 12|Imatinib PK trough plasma concentration (Cmin) was defined as any pre-dose Imatinib plasma concentration|Month 12|Pharmakokinetic (PK) population consisted of number of patients with a pre-dose PK sample at Month 12|||mg/mL||Standard Deviation|Mean
1290191|NCT00124748|Secondary|Mean Actual Dose Intensity Per Day|The mean actual dose intensity per day from start of treatment up to last dose or discontinuation was evaluated up to Month 36. Actual dose intensity (mg/day) = total dose/time on treatment (periods of zero dose are included)|start of treatment to Month 36|Safety analysis population (SAP): consisted of all patients who received at least one dose of study medication.Subjects are summarized according to the safety treatment allocation (the dose they actually received).|||mg/day||Standard Deviation|Mean
1290195|NCT00124748|Secondary|Estimated Rate of Progression to Accelerated Phase (AC)/Blast Crisis (BC) in Two Treatment Arms|(Accelerated Phase/Blast Crisis) AP/BC was defined as time between randomization and either (1) (Chronic Myeloid Leukemia) CML-related death (if death was primary reason for discontinuation) or (2) progression to AP or BC (during treatment). Estimated rate of AC/BC was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
1290196|NCT00124748|Secondary|Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms|PFS on study which was defined as time between randomization and either (1) death due to any cause on treatment of during follow-up after discontinuation of treatment or (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment during follow-up after discontinuation of study treatment. Estimated rate of PFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
1290197|NCT00124748|Secondary|Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms|EFS on treatment was defined as time between randomization and either (1) death due to any cause during study treatment, (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment, (3) loss of complete hematological response (CHR), or (4) loss of major cytogenic response (MCyR) while on treatment. Estimated rate of EFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
1290198|NCT00124748|Secondary|Time to First Complete Hematological Response (CHR)]|Complete Hematological Response (CHR) is defined is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement. Time to CHR (months) = (date of first CHR or censoring - date of randomization + 1) / 30.4375. Time to first CHR was evaluated using the Kaplan-Meier method.|60 months overall|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Months||95% Confidence Interval|Median
1290199|NCT00124748|Secondary|Time to First Complete Cytogenetic Response|Cytogenetic response (CyR) is the percentage of Philadelphia positive metaphases (among at least 20 metaphase cells in Bone Marrow) with Complete Cytogenetic Response (CCyR) being 0 percent. Time to CCyR (months) = (date of first CCyR or censoring - date of randomization + 1) / 30.4375. Time to first CCyR was evaluated using the Kaplan-Meier method.|60 months overall|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Months||95% Confidence Interval|Median
1290200|NCT00124748|Secondary|Time to First Major Molecular Response|"MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).~Time to MMR (months) = (date of first MMR or censoring - date of randomization + 1) / 30.4375. Time to first MMR was evaluated using the Kaplan-Meier method"|42 months overall|Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment.|||Months||95% Confidence Interval|Median
1290201|NCT00124748|Secondary|Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts|"Undetectable levels or Complete molecular response is defined as Bcr-Abl ratio (%) on international scale (IS) <= 0.0032% (≥ 4.5 log reduction of BCR-Abl transcripts from a standardized baseline)."|12 , 24, 36 and 42 months|Intent-to-treat (ITT) population consisted of all patients who were randomized into the study.|||Percentage of Partcipants|||Number
1290202|NCT00124748|Secondary|Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months|Complete Hematologic Response (CHR) is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement.|12, 24, 36, and 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percentage of participants|||Number
1290203|NCT00124748|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months|Cytogenetic response (CyR)is the percentage of Philadelphia chromosome positive metaphases (among at least 20 metaphase cells in bone marrow (BM)) with Complete Cytogenetic Response (CCyR) being 0 percent.|12, 24, 36, 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percentage of Participants|||Number
1290204|NCT00124748|Secondary|Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months|MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).|24, 36 and 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percentage of participants|||Number
1290205|NCT00124748|Primary|Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months|MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).|12 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percentage of participants|||Number
1290206|NCT00124735|Secondary|Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%|The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population|||minutes||Standard Deviation|Mean
1290642|NCT00120042|Primary|Placental Retention Rate|If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.|3 years||||participants|||Number
1290210|NCT00124709|Secondary|Patient/Caregiver Quality of Life|Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.|From Baseline to Visit 5 , 6, 8, 10, 12, and 14|Intent-to-Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|||Scores on PIQoL-AD Scale||Standard Deviation|Mean
1290211|NCT00124709|Secondary|Atopic Dermatitis (AD) Remission Time|"Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response (yes) to the question No or almost no eczema? and a response of no treatment except emollients to the question Medication used."|36 month Double-Blind Phase|Intent-to-Treat population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|||Days||Standard Deviation|Mean
1290212|NCT00124709|Secondary|Corticosteroid and Pimecrolimus Drug Use|"Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase.~Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months."|48 months|Safety population: all randomized patients who were dispensed study medication.|||Days of Exposure||Standard Deviation|Mean
1290213|NCT00124709|Secondary|Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies|"Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study.~Note: The results at six years are not reported due to early termination of the study."|6 years (36 month Double-Blind Phase)|Intent to Treat Population defined as all randomized patients who were dispensed study medication and had at least one post-baseline efficacy measurement.|||Percentage of Participants|||Number
1290214|NCT00124709|Secondary|Long Term Safety in Infants and Young Children|Note: The results of this secondary outcome is not reported due to early termination of the study.|6 years|||||||
1290215|NCT00124709|Primary|Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age|Note: The results for this efficacy variable are not reported due to early termination of the study.|6 years|||||||
1290216|NCT00124709|Primary|Atopic Dermatitis (AD) Disease Control Over 36 Months|Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|36 months|Intent to Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|||Proportion of disease free days||Standard Deviation|Mean
1290217|NCT00124657|Secondary|Number of Participants Experiencing Grade 3 or 4 Toxicity Events|Adverse events were collected systematically for each of the 44 Phase II participants from the time of enrollment to the completion of therapy (approximately 2 years from start of therapy).|From start of therapy through 2 years.|All 44 Phase II participants were evaluated. Eight of 16 participants with lymphopenia received dexamethasone within 4 weeks of the recorded toxicity. In both participants with headache, there was a documented progressive disease within 3 days of the recorded headache.|||Participants|||Number
1290218|NCT00124657|Secondary|Plasma and CSF Levels of VEGF, bFGF, and SDF1|This objective was to determine the plasma and CSF levels of the VEGF, bFGF, and SDF1 at diagnosis, and the plasma levels of these factors at regular intervals during therapy, and to analyze the association of these results with tumor response.|at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)|This objective became obsolete over the course of the protocol, and data was not collected.||||||
1290219|NCT00124657|Secondary|To Prospectively Investigate the Technical Factors Involved in Planning and Administering Conformal Fractionated RT as Outlined in This Study, and to Correlate RT Dosimetry With Patterns of Failure, Standard and Investigational Imaging and Toxicity||5 Years|This objective became obsolete over the course of the protocol, and data was not collected.||||||
1290220|NCT00124657|Secondary|Correlation Between Standard Magnetic Resonance Imaging and Investigational Radiologic Techniques in Assessing Tumor Response to This Treatment|This objective was to prospectively investigate the correlation between standard magnetic resonance imaging (MRI) and investigational radiologic techniques (MR spectroscopy, perfusion/diffusion, PET scan, DEMRI/BLAST) in assessing tumor response to this treatment.|at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)|This objective became obsolete over the course of the protocol, and data was not collected.||||||
1290221|NCT00124657|Secondary|Ability of Erlotinib to Inhibit EGFR Signaling|"The objective was to test the ability of erlotinib to inhibit the EGFR signaling in patients with high-grade glioma who required a second surgery.~This outcome was not assessed due to insufficient availability of tumor and control samples for analysis."|5 Years|This outcome was not assessed due to insufficient availability of tumor and control samples for analysis.||||||
1290222|NCT00124657|Primary|Progression Free Survival (PFS)|"Progression-free survival (PFS) distributions for the Phase II participants with anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) were calculated using Kaplan-Meier estimates (n=41). PFS was defined as the interval between treatment start and initial failure, including clinical or radiologic progression or death from any cause.~PFS was not calculated for the other disease types."|1 and 2 years after end of therapy|Per protocol, 41 participants with either anaplastic astrocytoma or glioblastoma multiforme were analyzed for this outcome.|||years||Standard Deviation|Mean
1290223|NCT00124657|Primary|Maximum Tolerated Dose (MTD) of Erlotinib|MTD was defined as the highest dosage level in which no more than one of six assessable participants experienced dose-limiting toxicities (DLT). The dosage of erlotinib was increased by approximately 30% in each dosage level starting at 80% of the MTD in adults with solid tumors. A traditional 3+3 dose escalation scheme was used to estimate the MTD.|During the first 8 weeks of therapy.|22 participants were analyzed for MTD over 4 dose levels. One of 23 enrolled participants was not evaluable due to early disease progression.|||mg/m^2|||Number
1290643|NCT00119847|Secondary|Filtered QRS Duration|Signal-averaged ECG|Baseline and one year||||Milliseconds||Standard Deviation|Mean
1290644|NCT00119847|Secondary|T-wave Variability|Variability in T wave morphology, change between baseline and one year|Baseline and one year||||Microvolts||Standard Deviation|Mean
1290224|NCT00124657|Secondary|Number of Positive Mutations of EGFR and Downstream Pathways|"Statistical analyses of genomic changes, expression profiles and validation studies should be considered in an exploratory and hypothesis-generating context.~Fresh frozen tumor tissue was obtained at the time of tumor resection and diagnosis. DNA was extracted from formalin-fixed, paraffin-embedded tissue. The entire PTEN coding sequence (exons 1-9), exons 1, 9 and 20 of PIK3CA, and exons 17-24 of EGFR were evaluated using exon-specific PCR amplification, and immunohistochemistry was done. Tumor lesions were considered positive if >25% cells were immunoreactive."|Once at tumor resection and diagnosis|Unstained slides were available for immunohistochemistry analysis in 21 of the 23 Phase I participants.|||participants|||Number
1290225|NCT00124657|Secondary|AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy, and Day 8 of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.|||mg*h/mL||Full Range|Median
1290226|NCT00124657|Secondary|Erlotinib Tmax|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.|||hours||Full Range|Median
1290227|NCT00124657|Secondary|Cmax of Erlotinib and Its Metabolite OSI-420|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy, and Day 8 of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.|||mg/mL||Full Range|Median
1290228|NCT00124657|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase elevation that returned to grade 1 or baseline within 7 days. After enrollment of the first 4 participants, grade 3 and 4 electrolyte abnormalities that resolved to ≤grade 2 within 7 days were excluded as DLT. Toxicities were graded according to the Common Terminology Criteria for Adverse Events version 3.0.|During the first 8 weeks of therapy|23 participants were enrolled on Phase I component; 22 were analyzed for DLT over 4 dose levels. 1 treated at dose level 120mg/m^2 was not assessable for DLT due to early tumor progression. 4 were treated before and 19 after the study was amended to exclude grade 3 and 4 electrolyte abnormalities that resolved to ≤ grade 2 within 7 days.|||participants|||Number
1290229|NCT00124618|Secondary|Tumor Response (Complete and Partial)|A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration||||participants|||Number
1290230|NCT00124618|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|From Baseline to up to 3 years||||months||95% Confidence Interval|Median
1290231|NCT00124618|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From baseline to up to 3 years||||months||95% Confidence Interval|Median
1290232|NCT00124618|Primary|11-month Survival Rate|Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with “success”, unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.|From baseline to 11 months.|This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an NCCTG audit. This analysis includes all 57 patients. Forty of 57 patients (70%) reached the 11-month survival primary point.|||percentage of participants|||Number
1290233|NCT00124579|Secondary|Progression-Free Survival|From date of initial registration to date of progression/relapse of disease (> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years|about 12-18 months|With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.|||Months||95% Confidence Interval|Median
1290246|NCT00124449|Secondary|Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline|SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement.|6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements)|||units on a scale||Standard Error|Mean
1290247|NCT00124449|Secondary|Number of Participants With Persistent Symptomatic Clinical Synovitis|Synovitis, assessed by clinical signs and symptoms|6, 12, and 24 months|All randomized and treated participants (n=number of participants with assessment at baseline and timepoint)|||Participants|||Number
1290234|NCT00124579|Primary|Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).|"Responses are defined as follows:~Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%.~Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein < 0.2gm/day. Bone marrow plasma cells must be ≤ 5%.~Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level."|1 year|Ninety patients is sufficient to distinguish between the null hypothesis that the response rate is 45% versus the alternative of a response rate of 60% with 89% power, using a one-sided test based on the binomial distribution with a significance level of 5%.|||percentage of participants|||Number
1290235|NCT00124579|Secondary|Toxicity Evaluation|To evaluate the qualitative and quantitative toxicities associated with this regimen.|From date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years|All participants receiving at least one dose of induction therapy|||Participants|||Number
1290236|NCT00124462|Primary|Change in WOMAC Function Scale (Most Symptomatic Treated Knee)|The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.|Baseline and 12 weeks||||units on a scale change from baseline||Standard Deviation|Mean
1290237|NCT00124462|Primary|Mean Change WOMAC Pain Scale (Most Symptomatic Treated Knee)|The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.|Baseline and 12 weeks||||units on a scale change from baseline||Standard Deviation|Mean
1290238|NCT00124449|Secondary|Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies|Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of > 400 and for tip assessment was ≥25.|Up to 12 months||||participants|||Number
1290239|NCT00124449|Secondary|Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths|AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely|Throughout the treatment period (6 months)|All subjects who received at least 1 dose of study medication|||Participants|||Number
1290240|NCT00124449|Secondary|Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response|This questionnaire includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. Higher scores indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline.|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).|||Participants|||Number
1290241|NCT00124449|Secondary|Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)|The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (< 2.6).|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).|||Participants|||Number
1290242|NCT00124449|Secondary|DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline|The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement.|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).|||units on a scale||Standard Error|Mean
1290243|NCT00124449|Secondary|Frequency of Human Leukocyte Antigen (HLA) Typing|To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404).|Day 1|All randomized and treated participants|||participants|||Number
1290244|NCT00124449|Secondary|Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time|To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive|Day 1, 6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with measure at timepoint).|||Participants|||Number
1290245|NCT00124449|Secondary|Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months|To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], tumor necrosis factor Alpha [TNF-Alpha], Matrix Metalloproteinase 3T [MMP3T], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement.|Baseline, 6 Months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements).|||laboratory values||Standard Error|Mean
1290248|NCT00124449|Secondary|Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months|Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score.|Baseline, 6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements). MRIs were done only in participants at European Union sites.|||units on a scale||Standard Error|Mean
1290249|NCT00124449|Secondary|Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months|Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement.|Baseline, 6 months, 12 months, 24 months|n=participants with a score at baseline and at timepoint|||units on a scale||Standard Error|Mean
1290250|NCT00124449|Secondary|Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease|Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.|12 months, 24 months|n=Randomized and treated participants who were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in the 1- or 2-year window were excluded from the analysis).1 participant in Placebo group was excluded due to the presence of RA at baseline.|||Participants|||Number
1290251|NCT00124449|Secondary|Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy|ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.|24 months|Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 2-year window were excluded from the analysis). 1 subject in the Placebo group is excluded due to presence of RA at baseline.|||Participants|||Number
1290252|NCT00124449|Primary|Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy|ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.|12 months|Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 1-year window were excluded from the analysis). 1 participant in Placebo group was excluded due to presence of RA at baseline.|||Participants|||Number
1290253|NCT00124176|Secondary|Serum Albuterol S Isomer Levels||After 6 hours of continuous albuterol||||ng/mL||Standard Deviation|Mean
1290254|NCT00124176|Secondary|Serum Potassium Levels||After 12 hours of continuous nebulization||||mg/dL||Standard Deviation|Mean
1290255|NCT00124176|Secondary|Heart Rate||After 12 hours of continuous nebulization||||beats per minute||Standard Deviation|Mean
1290256|NCT00124176|Secondary|Change in Pediatric Asthma Severity Score|"Change in Pediatric Asthma Severity Score. Range 0 (best) - 6 (worst)~Score at each time point is calculated by adding 3 elements:~Wheeze (0= None/Mild, 1=Moderate, 2=Severe) Prolonged expiration (0= None/Mild, 1=Moderate, 2=Severe) Work of breathing (0= None/Mild, 1=Moderate, 2=Severe)"|After 12 hours of continuous nebulization||||units on a scale||Standard Deviation|Mean
1290257|NCT00124176|Primary|Duration of Continuous Therapy|standard intention to treat (ITT) analysis|During hospitalization||||Hours||Inter-Quartile Range|Median
1290258|NCT00124072|Secondary|Total Strokes||6.7 years median follow-up|||||||
1290259|NCT00124072|Secondary|Major Coronary Events|Non-fatal MI, coronary death or coronary revascularisation|6.7 years median follow-up|||||||
1290260|NCT00124072|Secondary|MVEs in Presence and Absence of the Other Factorial Treatment||6.7 years median follow-up|||||||
1290261|NCT00124072|Secondary|MVEs in Patients Subdivided Into 3 Groups by Baseline Low-density Lipoprotein (LDL)||6.7 years median follow-up|||||||
1290262|NCT00124072|Secondary|MVEs Separately in Year 1 and in Later Years||6.7 years median follow-up|||||||
1290263|NCT00124072|Primary|Major Vascular Events (MVE)|Major vascular events (MVE) defined as major coronary events (MCE [non-fatal MI, coronary death or coronary revascularisation]), non-fatal or fatal stroke, or peripheral revascularization (peripheral artery angioplasty or arterial surgery, including amputations), during the scheduled study treatment period.|6.7 years median follow-up||||Participants|||Number
1290264|NCT00124020|Primary|Clinical Response|"Clinical Response: Categorical (Cured, Failed or Indeterminate)~Failure - at least one of the following:~Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy~Termination of study med due to “lack of efficacy”~Death on or after Day 3 attributable to primary infection~Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.~Indeterminate: Inability to determine outcome"|7-14 days following end of antibiotic treatment||||participants|||Number
1290265|NCT00123955|Secondary|Left Ventricular Diastolic Stiffness|"Echocardiography Doppler measurement of left ventricular diastolic function:~Early mitral annulus velocity (lateral) (Ea; cm/s)"|Baseline, 4 month and 9 month||||cm/s||Standard Deviation|Mean
1290266|NCT00123955|Secondary|Concentric Left Ventricular Remodeling|"Left ventricle measurements by MRI:~Mass/end diastolic volume ratio: g/ml"|Baseline, 9 month||||g/ml||Standard Deviation|Mean
1290267|NCT00123955|Primary|Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score|"The Minnesota Living with Heart Failure Questionnaire (MLHF) is a self-administered disease-specific questionnaire for patients with Heart Failure, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0–105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0–40) and emotional (5 items, range 0–25). The other eight items (of the total of 21) are only considered for the calculation of the total score.~Scale of 0-105:The higher the score the worse the heart failure related Quality of Life."|Baseline, 4 and 9 months||||units on a scale||Standard Deviation|Mean
1290268|NCT00123955|Primary|Exercise Intolerance|Peak exercise VO2|Baseline, 4 and 9 months|The outcome measure data uses data from all participants with 4 and/or 9 month follow-up. Thirty-seven participants randomized to spironolactone and 35 participants randomized to placebo completed 4 months of follow-up, and 37 participants randomized to spironolactone and 34 participants randomized to placebo completed 9 months of follow-up.|||ml/kg/min||Standard Deviation|Mean
1290269|NCT00123734|Secondary|To Provide Estimates of the Sensitivity and Specificity of [99mTc] ThromboView® for DVT at the 1-hour and 3-hour Imaging Time Points||May 2007|||||||
1290270|NCT00123734|Secondary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Sensitivity||95% Confidence Interval|Mean
1290271|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Specificity||95% Confidence Interval|Mean
1290272|NCT00123734|Primary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® in Patients With Confirmed Initial DVT.||September 2005||||% Sensitivity||95% Confidence Interval|Mean
1290273|NCT00123734|Secondary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Sensitivity||95% Confidence Interval|Mean
1290274|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Specificity||95% Confidence Interval|Mean
1290275|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Suspected Recurrent DVT in Whom Disease Recurrence Has Been Excluded||May 2007|Number of participants with suspected recurrent DVT with evaluable images|||% Specificity||95% Confidence Interval|Mean
1290276|NCT00123734|Primary|To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Specificity||95% Confidence Interval|Mean
1290277|NCT00123682|Secondary|Self-reported Quit Attempt||6 months||||percentage of participants|||Number
1290278|NCT00123682|Secondary|Use of Cessation Medications||6 months||||percentage of participants|||Number
1290279|NCT00123682|Primary|7-day Point Prevalence Abstinence From Smoking||6 month||||percentage of participants|||Number
1290280|NCT00123643|Primary|Flow Mediated Dilation|Measure of endothelial function|change from baseline to 6 months|All completers were analyzed|||percent change||Standard Deviation|Mean
1290281|NCT00123630|Primary|Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups||16 weeks|The analysis was per protocol. There were no subjects who were withdrawn or lost to follow-up in this study.|||perecentage of eos per high power field|||Number
1290282|NCT00123604|Primary|Flow Mediated Dilation|Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.|change from baseline to 5 months||||percentage of change in dilation||Standard Deviation|Mean
1290283|NCT00123487|Secondary|Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants|A12-lead ECG was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Day 8 and 29. Additional ECGs were done at the Investigator’s discretion. ECGs were read centrally. QT Interval corrected with Fridericia formula was measured in msec.|Baseline up to Year 2|All participants who received at least one dose of study drug and had appropriate ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.|||participants|||Number
1290284|NCT00123487|Secondary|Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants|A12-lead electrocardiogram (ECG) was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Days 8 and 29. Additional ECGs were done at the Investigator’s discretion. ECGs were read centrally. The QT interval corrected with Fridericia formula is presented with categories of changes from baseline (BL) in milliseconds (msec).|Baseline to Year 2|All participants who received at least one dose of study drug and had appropriate baseline and on-study ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.|||participants|||Number
1290285|NCT00123487|Secondary|Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants|Laboratory abnormalities were graded according to the NCI CTC version 3.0. Grade 3 and 4 criteria were defined as follows: Upper limit of normal (ULN). Alanine transaminase (ALT) Grade (Gr) 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase (AST) Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. Serum creatinine (H) Gr 3: >3.0 to 6.0*ULN; Gr 4: >6.0*ULN. Calcium (L) Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; Phosphorus (L): Gr 3: <2.0 – 1.0 mg/dL , Gr 4: <1.0 mg/dL. Non-hematologic laboratory results were not collected beyond Year 2. Baseline values were obtained within 2 weeks prior to randomization.|Baseline to Year 2|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Participants who did not have a parameter reported at baseline are indicated.|||participants|||Number
1290645|NCT00119847|Primary|Short-termed Fractal Scaling Exponent (Alpha 1)|Nonlinear measurement of heart rate variability, change between baseline and 1 year is the primary outcome.|Baseline, one year||||unit-less||Standard Deviation|Mean
1290286|NCT00123487|Secondary|Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations|Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0. Grade 4 hematology evaluations used to determine myelosuppression included: WBC: <1.0*10^9/L. ANC: <0.5*10^9/L. Platelet count <25.0 to 10^9/L.|Day 1 up to Year 7|All participants who received at least one dose of study drug and had laboratory evaluations available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.|||participants|||Number
1290287|NCT00123487|Secondary|Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants|Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) version 3.0. CTC Grade 3 and 4 criteria are defined as follows: White blood cells (WBC): Grade (Gr) 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Baseline was laboratory value obtained within 2 weeks prior to randomization.|Baseline to Year 2|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Those participants who did not have a parameter reported at baseline are indicated.|||participants|||Number
1290288|NCT00123487|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants|With protocol Amendment 6, the duration of the study was extended for 2 additional years (7 years total) for participants who continued to have clinical benefit and no feasible alternate access to dasatinib. However, after Year 5 the requirement to follow participants for survival and to collect other efficacy data was removed from the protocol for the remainder of the study. Only AEs and SAEs were collected up to Year 7. On-study AEs and SAEs were graded by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The investigator AE terms were coded and grouped by preferred term and system organ class using the Medical Dictionary for Regulatory Activities (MedDRA), version 16.0.|Day 1 to Year 7|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.|||participants|||Number
1290289|NCT00123487|Secondary|Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population|PFS was defined as time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. OS was defined as time from randomization until date of death. Participants who had not died or were lost to follow-up were censored on the last date they were known to be alive. Median duration was measured in months.|24 months, 36 months, 48 months, 60 months|Participants were analyzed based on the treatment they were randomized to receive. Kaplan-Meir estimates of PFS or OS (95% Confidence Interval) are provided below.|||percentage of participants||95% Confidence Interval|Number
1290290|NCT00123487|Secondary|Median Overall Survival (OS) - Randomized Population|OS was defined as time from randomization until date of death. Participants who had not died or who were lost to follow-up were censored on the last date on which the participant was known to be alive. Median duration was measured in months.|Randomization up to 5 Years|Participants were analyzed based on the treatment they were randomized to receive.|||Months||95% Confidence Interval|Median
1290291|NCT00123487|Secondary|Median Progression Free Survival (PFS) - Randomized Population|PFS was defined as: Time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. Median duration was measured in months.|Randomization up to 5 Years|Participants were analyzed based on the treatment they were randomized to receive.|||Months||95% Confidence Interval|Median
1290292|NCT00123487|Secondary|Number of Participants With Best Cytogenic Response (CyR) - Randomized Population|Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.|||participants|||Number
1290293|NCT00123487|Secondary|Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population|Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM; Major cytogenetic response (MCyR) was defined as CCyR or PCyR. Percentage: number of participants with MCyR and denominator is number of randomized participants.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
1290294|NCT00123487|Secondary|Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population|Type of hematologic response: CHR defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and <100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Minor Hematologic Response (MiHR): <15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Major hematologic response (MaHR ) was CHR or NEL. Overall hematologic response was CHR or NEL or MiHR.|Randomization up to 6 months, 2 years|Participants were analyzed based on the treatment they were randomized to receive.|||participants|||Number
1290295|NCT00123487|Secondary|Percent of Participants With Overall Hematologic Response - Randomized Population|Overall Hematologic Response (OHR) was defined as CHR, NEL or minor hematologic response (MiHR). CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. MiHR defined as: < 15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Percentage: participants with OHR/ randomized participants.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
1290296|NCT00123487|Secondary|Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study|MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Median duration was measured in months.|Day 1 up to 5 years|Participants who achieved a MaHR during the study.|||Months||95% Confidence Interval|Median
1290297|NCT00123487|Secondary|Median Time to Major Hematologic Response (MaHR) - Randomized Population|A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.|Day 1 up to 6 months (time of primary endpoint), 2 years|Participants were analyzed based on the treatment they were randomized to receive.|||Months||95% Confidence Interval|Median
1290298|NCT00123487|Secondary|Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population|MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.|Randomization up to 2 years|Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group.|||percentage of participants||95% Confidence Interval|Number
1290299|NCT00123487|Secondary|Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population|A MaHR was defined as a participant having either CHR or NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percent: number of participants with MaHR /number of participants randomized.|Randomization up to 2 years|Participants were analyzed based on the treatment they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
1290300|NCT00123487|Primary|Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population|MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants.|Randomization up to 6 months|Participants were analyzed based on the treatment they were randomized to receive (not what they actually received). 95% exact confidence interval (CI) presented.|||percentage of participants||95% Confidence Interval|Number
1290325|NCT00123409|Secondary|Reduced Problems Related to Alcohol|The Short Inventory of Problmes was used to measure the number of alcohol related problems encountered in the prior 3 months. The scale has a minimum of 0 with lower as better. The max score is 15 with each problem rated as present or absent.|12 months||||# of alcohol problems||Standard Deviation|Mean
1290301|NCT00123474|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.|Baseline to 30 days post last dose, up to 7 years (study closure July 2014)|All randomized participants who received at least one dose of study drug were summarized.|||participants|||Number
1290302|NCT00123474|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants.|Baseline to 30 days post last dose, up to 24 months|All randomized participants who received at least one dose of study drug were summarized.|||participants|||Number
1290303|NCT00123474|Secondary|Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All participants who were randomized to a treatment arm were summarized.|||percentage of participants||95% Confidence Interval|Number
1290304|NCT00123474|Secondary|Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All participants who were randomized to a treatment arm were summarized.|||percentage of participants||95% Confidence Interval|Number
1290305|NCT00123474|Secondary|Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up|Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date. No cytogenic assessments were made after 2 years of follow-up.|24 months|All randomized participants were summarized.|||percentage of participants||95% Confidence Interval|Number
1290306|NCT00123474|Secondary|Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up|Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months|All randomized participants were summarized.|||percentage of participants||95% Confidence Interval|Number
1290307|NCT00123474|Secondary|Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-intolerant participants were summarized.|||percentage of participants||95% Confidence Interval|Number
1290326|NCT00123409|Primary|Reduced Alcohol Use|Alcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.|12 months||||Days drinking||Standard Deviation|Mean
1290327|NCT00123162|Secondary|Improvement in Pain Severity Determined by Visual Analog Scale (VAS).|"The Visual Analog Scale (VAS) assesses pain intensity. The scale is 100 mm long; the extremes of the scale are to the left, no pain and to the right, worst pain I have ever felt. The VAS score is determined by measuring the distance (in mm) from the left side of the scale to the point that the patient marked. The score ranges from 0 to 100, with higher values indicating greater pain."|Each hour of the study (0, 1, 2, 3, 4).||||mm||Standard Deviation|Mean
1290308|NCT00123474|Secondary|Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-intolerant participants with available data were summarized|||percentage of participants||95% Confidence Interval|Number
1290309|NCT00123474|Secondary|Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up|A CHR was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months, 24 months|All randomized imatinib-intolerant participants were summarized.|||percentage of participants|||Number
1290310|NCT00123474|Secondary|Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose|CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR.|6 months, 24 months|All randomized imatinib-intolerant participants with available data were summarized.|||percentage of participants||95% Confidence Interval|Number
1290311|NCT00123474|Secondary|Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-resistant participants were summarized.|||percentage of participants||95% Confidence Interval|Number
1290312|NCT00123474|Secondary|Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-resistant participants were summarized.|||percentage of participants||95% Confidence Interval|Number
1290313|NCT00123474|Secondary|Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants|BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).|Baseline up to 24 months|All randomized, treated participants with available mutation data were summarized.|||participants|||Number
1290314|NCT00123474|Secondary|Number of Participants With CHR Whose Disease Progressed by 24 Months|Progression in a participant=achieved a CHR and subsequently no longer met the criteria consistently over a consecutive 2-week period after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; met the criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of CHR, medium duration of CHR could not be estimated because the majority of participants with CHR continued to respond, or could not be reliably estimated because of the large number of censored participants.|24 months|All imatinib-resistant participants who achieved CHR and then experienced disease progression were summarized.|||participants|||Number
1290328|NCT00123162|Primary|The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo.|The Total Pain Relief (TOPAR) Scale rates the level of pain relief on a scale of 0=None, 1=Mild, 2=Moderate, 3=Excellent, 4=Complete. The TOPAR scale was completed each hour after administration of study drug for a total of 4 hours. The 4 hourly scores were summed for a final TOPAR4 score that ranged between 0 and 16, with higher values indicating greater pain relief over time. Missing TOPAR scores after the first hour were imputed using the last-observation-carried-forward approach.|Hours 1, 2, 3 and 4.||||units on a scale||Standard Deviation|Mean
1290963|NCT00117572|Secondary|Quality of Life (Normalcy of Diet)|Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)|Change from baseline to 1 year (1 year-pre)|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
1290315|NCT00123474|Secondary|Number of Participants With MCyR Whose Disease Progressed by 24 Months|Progression in a participant=participant achieved a CHR and no longer met the criteria consistently over consecutive 2-weeks after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; participant met criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of MCyR, medium duration of MCyR could not be estimated because the majority of participants with MCyR continued to respond, or could not be reliably estimated because of the large number of censored participants. Cytogenetic assessments were not done after the 24 month follow-up.|24 months|All imatinib-resistant participants who had achieved MCyR and experienced disease progression were summarized.|||participants|||Number
1290316|NCT00123474|Secondary|Time to CHR in Participants With CHR At 24 Months Follow-Up|Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.|24 months|Randomized imatinib-resistant participants with CHR were summarized.|||Months||95% Confidence Interval|Median
1290317|NCT00123474|Secondary|Time to MCyR in Participants With MCyR at 24 Months Follow-Up|Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.|24 months|Randomized imatinib-resistant participants with MCyR were summarized.|||Months||95% Confidence Interval|Median
1290318|NCT00123474|Secondary|Time to CHR in Participants With CHR at 6 Months Follow-Up|Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).|6 months|Randomized imatinib-resistant participants with CHR and available data were summarized.|||Months||95% Confidence Interval|Median
1290319|NCT00123474|Secondary|Time to MCyR in Participants With MCyR at 6 Months Follow-Up|Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).|6 months|Randomized imatinib-resistant participants with MCyR and available data were summarized.|||Months||95% Confidence Interval|Median
1290320|NCT00123474|Secondary|Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up|A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months, 24 months|All randomized imatinib-resistant participants with available data were summarized.|||percentage of participants||95% Confidence Interval|Number
1290321|NCT00123474|Secondary|Percent of Participants With MCyR At or Prior to 24 Months Follow-Up|CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.|24 months|All randomized imatinib-resistant participants with available data were summarized.|||percentage of Participants||95% Confidence Interval|Number
1290322|NCT00123474|Primary|Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up|Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.|6 months|All randomized imatinib-resistant participants with available data were summarized.|||percentage of Participants||95% Confidence Interval|Number
1290323|NCT00123422|Secondary|Inspiratory Capacity|Inspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.|14 weeks|Intent-to-treat analysis was used so data on all randomized patients were analyzed.|||Liters||Standard Deviation|Mean
1290324|NCT00123422|Primary|Exercise Endurance|Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.|14 weeks|We used an intent-to treat analysis using the last value carried forward. All participants were included in the final analysis.|||minutes||Standard Deviation|Mean
1290329|NCT00123123|Secondary|Clinical Pulmonary Infection Score (CPIS) at 48 Hours|"The CPIS score was calculated as follows: 1) Fever: 0 (36.5 to 38.4°C), 1 (38.5 to 39), 2 (<36.0 OR >39.0); 2) Leukocytosis: 0 (4000 to 11,000 white blood cells per mm3 of blood), 1 (11,000 to 17,000), 2 (>17,000); 3) New infiltrate:~0 = None, 1 = Patchy, 2 = Localized; 4) Secretions: 0 = None to minimal, 1 = moderate, 2 = large amount; and 5) PaO2/ FiO2: 0 = more than 330 and 2 = less than 330. Total scores for the subscales can range from 0-10, with lower scores indicating better outcome."|48 hours||||units on a scale||Standard Deviation|Mean
1290330|NCT00123123|Primary|Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours|Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.|Every 48 hours until discharge|All tests were carried out using intent-to-treat analysis, with two-sided tests with a significance level of 0.05. Baseline comparisons between groups were made by analysis of variance (ANOVA) and/or the chi-squared test, as appropriate.|||CFU/mL||Standard Deviation|Mean
1290331|NCT00122980|Secondary|Growth and Development - Weight (Change From Baseline to Endpoint)||baseline to end of study participation (up to 136 weeks)|Intent-to-Treat with endpoint data|||kg||Standard Deviation|Mean
1290332|NCT00122980|Secondary|Growth and Development - Height (Change From Baseline to Endpoint)||Baseline to end of study participation (up to 136 weeks)|Intent-to-Treat with endpoint data|||cm||Standard Deviation|Mean
1290333|NCT00122980|Secondary|Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)- Verbal Ability|This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Higher scores mean better abilities/achievements. Scaled scores range from 0-100.|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat. Because the study was terminated, it was not possible to schedule the full battery of neurological assessments on all subjects. Only subjects with both baseline and end of study assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
1290334|NCT00122980|Secondary|Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)-Excluding Verbal|This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Scaled scores range from 0-100. Higher scores mean better abilities/achievements.|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat. Because the study was terminated, it was not possible to schedule the full battery of neurological assessments on all subjects. Only subjects with both baseline and end of study assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
1290335|NCT00122980|Secondary|Barthel Index (Change From Baseline)|The Barthel Index is a measure of activities of daily living (ADL) and assesses the degree of disability in a particular participant. The index records indicators of independence in terms of the disability caused by impairments, such as those that may be sequelae of stroke. The index was used as a record of what the participant did, not as a record of what the participant could do. Barthel scores range from 0 to 100, with higher scores indicating greater independence in daily living activities (caring for oneself).|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat|||units on a scale||Standard Deviation|Mean
1290336|NCT00122980|Secondary|Pediatric Quality of Life (PedsQL) - Child Report (Change From Baseline)|The PedsQLTM Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.|Baseline, midpoint (week 64), and study exit (up to 30 months of treatment)|Intent-to-Treat|||units on a scale||Standard Deviation|Mean
1290337|NCT00122980|Secondary|Pediatric Quality of Life (PedsQL) - Parent Report (Change From Baseline)|The PedsQL(TM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.|Baseline, mid-point (week 64), and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat|||units on a scale||Standard Deviation|Mean
1290338|NCT00122980|Primary|Liver Iron Content (LIC) Change-from-baseline|LIC change-from-baseline is the second component of the composite primary endpoint. LIC was measured by quantitative liver biopsy at baseline and at 30 months or exit from the study.LIC values were transformed into Log10 values prior to computing the change from baseline.|Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)|Intent-to-treat AND both baseline and 30-month post-treatment LICs.|||mg ferritin/gram dry weight liver||Standard Deviation|Log Mean
1290339|NCT00122980|Primary|Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period|Secondary stroke is the first component of the composite primary endpoint and considers the number of participants with recurrent secondary stroke events during 30 months of treatment. Stroke was defined as any clinical event with brain injury due to vascular disease. All neurological events underwent formal stroke adjudication.|Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)|The Intent-to-Treat population included all subjects who were randomized and who received any on-study treatment.|||participants|||Number
1290455|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
1290340|NCT00122954|Secondary|Quality of Life (SF-36)|SF-36 is a commonly used measure of health-related quality of life and is well validated in many disease conditions. Responses are self-administered and responses are summed into two subscores, the mental component summary (MCS) and physical component summary (PCS). The SF-36 has eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed on a 0-100 scale. Higher scores represent higher function.|baseline to 3 months|A total of 8 participants discontinued (placebo n = 2, 1 colitis, 1 swallowing problems; treatment n = 8, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off anti-depressant, 1 travel difficulties) and did not complete measures at end of study|||mean change of units on a scale||Standard Error|Mean
1290341|NCT00122954|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Higher MADRS scores indicate more severe depression, and the overall score ranges from 0-60. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and > 34 severe. Our primary outcome was 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS).|baseline to 3 months|A total of 8 participants discontinued intervention (placebo n = 2, 1 colitis and 1 swallowing problems; treatment n = 6, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off antidepressant, 1 travel issues) and did not complete outcome measures|||percentage of subjects|||Number
1290342|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection|Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.|||Participants|||Count of Participants
1290343|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection|GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1290344|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.|Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.|||Participants|||Count of Participants
1290345|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection|GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1290346|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection|Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.|||Participants|||Count of Participants
1290347|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection|GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1290348|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.|Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.|||Participants|||Count of Participants
1290349|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection|GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1290350|NCT00122681|Secondary|Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)|Titers were expressed as GMTs.|At month 0, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1290501|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^6 c/µL||Standard Error|Mean
1290351|NCT00122681|Secondary|Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)|"Seropositivity was defined as subjects with a titer equal to or greater than 40.~Subjects with an antibody titer smaller than 40 prior to vaccination were seronegative prior to vaccination and subjects with a titer equal to or greater than 40 were seropositive prior to vaccination."|At Month 0, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity which included subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1290352|NCT00122681|Secondary|HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)|Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).|Month 0, 7, 12, 24|The analyses was performed on the Total Vaccinated cohort on subjects with available results.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1290353|NCT00122681|Secondary|HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)|"HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination.~HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL."|Month 0, 7, 12 and 24|Analyses was performed on the Total Vaccinated Cohort on subjects with available results.|||Participants|||Count of Participants
1290354|NCT00122681|Secondary|Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset|"Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).~GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA [seronegative (sero-) or seropositive (sero+)]."|At Months 6, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1290355|NCT00122681|Secondary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus|"Cut-off values assessed for seropositivity include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)"|At Months 6, 7, 12, 24, 36 & 48|The analyses were performed on the ATP cohort for immunogenicity on evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1290356|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
1290357|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
1290358|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
1290359|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
1290367|NCT00122681|Secondary|Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus|Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.|Throughout the entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.|||subjects|||Number
1290360|NCT00122681|Secondary|Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12.|||Participants|||Count of Participants
1290361|NCT00122681|Secondary|Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12|||Participants|||Count of Participants
1290362|NCT00122681|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
1290363|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types|"Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.~HRW-HPV = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.|||Participants|||Count of Participants
1290364|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types|"Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.~HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.|||Participants|||Count of Participants
1290365|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12|||Participants|||Count of Participants
1290366|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12|||Participants|||Count of Participants
1290368|NCT00122681|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.|||Participants|||Count of Participants
1290369|NCT00122681|Secondary|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the entire study (Month 0 to 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.|||Participants|||Count of Participants
1290370|NCT00122681|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort. The data are presented stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or 18 serostatus (by ELISA).|||Participants|||Count of Participants
1290371|NCT00122681|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days after any vaccination|Analysis was performed on the Safety Subset of the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.|||Participants|||Count of Participants
1290372|NCT00122681|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (measured in degree celsius (°C) by axillary route), gastrointestinal symptoms, headache, myalgia, rash and urticaria.~Data are presented across the 3 doses."|Within 7 days after any vaccination|Analysis was performed on a safety subset of the Total vaccinated cohort, which included vaccinated subjects from certain sites. Data are presented for the total subset (total), then stratified subject HPV-16/18 DNA & serostatus at baseline: DNA positive (DNA+) or negative (DNA-), ELISA seropositive (sero+) or seronegative (sero-).|||Participants|||Count of Participants
1290373|NCT00122681|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
1290374|NCT00122681|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)|"CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.|||Participants|||Count of Participants
1290375|NCT00122681|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)|"CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.|||Participants|||Count of Participants
1290376|NCT00122460|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007|Safety population|||participants|||Number
1290433|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|60 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290377|NCT00122460|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning.|at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007|Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab +chemotherapy/chemotherapy alone): Baseline:123/109; Cycle3:87/69; Month6:48/23|||scores on a scale||Standard Error|Least Squares Mean
1290378|NCT00122460|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007|Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22|||scores on a scale||Standard Error|Least Squares Mean
1290379|NCT00122460|Secondary|Duration of Response|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||months||95% Confidence Interval|Median
1290380|NCT00122460|Secondary|Time to Treatment Failure|"Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment."|Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||months||95% Confidence Interval|Median
1290381|NCT00122460|Secondary|Disease Control|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments according to investigator (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||percentage of participants||95% Confidence Interval|Number
1290382|NCT00122460|Secondary|Best Overall Response|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||percentage of participants||95% Confidence Interval|Number
1290383|NCT00122460|Secondary|Progression-free Survival Time (PFS)|"Duration from randomization until radiological progression according to investigator (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||months||95% Confidence Interval|Median
1290384|NCT00122460|Primary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|"Primary analysis on Intent to Treat (ITT) population (allocation to treatment groups as randomized).~Analysis performed after the required number of 340 deaths had been reported (expected effect: 36% increase in median survival time, power = 80%, alpha=5% (two-sided)). The Clinical cut-off date was 12 Mar 2007."|||months||95% Confidence Interval|Median
1290385|NCT00122447|Other Pre-specified|AIM 2: Difference in FMD (Measure of Endothelial Function)|"Comparison of FMD (measure of endothelial function) between NGT, IGT and diabetes at baseline. FMD is a surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression.~No analysis was conducted due to under-recruitment."|Cross-sectional|||||||
1290386|NCT00122447|Primary|AIM 1: Change in Flow Mediated Dilation (FMD) (%)|Surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression|12 months of intervention|Based on the number of subjects who completed 12 months of intervention and testing|||percentage of arterial dilation change||Standard Deviation|Mean
1290387|NCT00122447|Secondary|AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level|Inflammatory marker|12 months of intervention|Based on the number of subjects who completed 12 months of intervention and testing|||mg/L||Standard Error|Mean
1290388|NCT00122382|Secondary|Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period|Number of participants with laboratory values (hematology, liver and kidney functions, electrolytes, glucose tests, protein tests, metabolite tests, and urine chemistry tests) considered markedly abnormal according to prespecified protocol criteria|Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.|All treated in the DB period. n=Number of participants evaluated for this measure.|||participants|||Number
1290389|NCT00122382|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.|All treated participants in the Double-Blind period|||participants|||Number
1290390|NCT00122382|Secondary|Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)|Mean difference observed in change from baseline to Month 12 and between Month 12 and Month 24 in radiographic scores (Total Score). To assess joint damage, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 12, Month 24|Analysis includes all treated participants in the open-label period originally randomized to abatacept. Analysis includes all participants with observed assessments collected at Baseline (Day 1), Day 365 (Month 12), and Day 729 (Month 24)|||units on a scale||Standard Error|Mean
1290391|NCT00122382|Secondary|Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12|Participants with no radiographic progression ((defined as change in score <=0 or <=0.5), sustained from Month 12 and Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Month 12, Month 24|Number of Participants Analyzed=All treated participants in the open-label period. (Treatment groups represent treatment received in the double-blind period.) n=the number of subjects with observed data included in the analysis.|||Participants|||Number
1290392|NCT00122382|Secondary|Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24|Participants with no radiographic progression (defined as change in score <=0 or <=0.5), from baseline to Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 24|All treated participants in the open-label period. Treatment groups represent treatment received in the double-blind period.|||Participants|||Number
1290393|NCT00122382|Primary|Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period|Marked abnormalities in hemoglobin >3 g/dL decrease from PRE-RX; hematocrit <0.75x PRE-RX; erythrocytes <0.75x PRE-RX; platelet count <0.67x lower limit of normal (LLN) or >1.5x ULN or if PRE-RX <LLN then <0.5x PRE-RX and <100,000/mm3; leukocytes <0.75x LLN or >1.25x ULN or if PRE-RX <LLN then <0.8x PRE-RX or >ULN if PRE-RX >ULN then >1.2x PRE-RX or <LLN; neutrophils if value <1.00 x10^3 c/uL; lymphocytes if value <.750 x10^3 c/uL or if value >7.50 x10^3 c/uL; monocytes if value >2000/MM3; basophils if value >400/mm3; eosinophils if value >.750 x10^3 c/uL|Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All participants treated during the open-label period; n= number of participants evaluated for this measure.|||participants|||Number
1290394|NCT00122382|Primary|Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period|Number of subjects with high liver function and kinedy tests: alkaline phosphatase (ALP) >2x upper limit of normal (ULN) or if pretreatment (PRE-RX) >ULN then >3x PRE-RX; aspartate aminotransferase (AST) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; alanine aminotransferase (ALT) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; g-glutamyl transferase (GGT)>2x ULN or if PRE-RX >ULN then >3x PRE-RX; total bilirubin >2x ULN or if PRE-RX >ULN then >4x PRE-RX; blood urea nitrogen >2x PRE-RX; creatinine >1.5x PRE-RX.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All Treated participants in the Open-label Period; n=number of participants evaluated for this measure.|||participants|||Number
1290395|NCT00122382|Primary|Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period|There were 107 Prespecified, acute-infusional SAEs (occurring within 1 hour after the start of study drug infusion) pre-specified in the protocol; anaphylactic shock was the only one occuring in this study.|Open-Label Period (Month 12 to Month 24)|All participants treated during the Open-Label period.|||Participants|||Number
1290434|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|50 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290435|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|40 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290396|NCT00122382|Primary|Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants|The incidence rates of malignant neoplasms are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.|||number of patients/100 patient-years|||Number
1290397|NCT00122382|Primary|Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants|The incidence rates of infections and infestations are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.|||Number of patients/100 patient-years|||Number
1290398|NCT00122382|Primary|Incidence Rates of Autoimmune Disorders in ABA-Treated Participants|The incidence rates of autoimmune disorders are defined as the (number of patients experiencing the event/exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.|||Number of participants/100 patient-years|||Number
1290399|NCT00122382|Primary|Number of Participants With SAEs With an Outcome of Death During the Open-label Period|Any untoward medical occurrence (SAE) that resulted in death|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.|||participants|||Number
1290400|NCT00122382|Secondary|Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Postbaseline - baseline value.|Baseline, Month 24|All treated participants in the open-label period. Because the analysis was change from baseline, only those with baseline and post-baseline were included. Linear extrapolation imputation was applied. Treatment groups represent treatment received in the double-blind period.|||units on a scale||Standard Deviation|Mean
1290401|NCT00122382|Secondary|Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24|Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.|Baseline, Month 24|All treated participants in the Open-label period. Treatment groups represent treatment received in the Double Blind Period.|||participants|||Number
1290402|NCT00122382|Secondary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA|Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).|Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|Treated participants in the open-label period were evaluated for anti-abatacept or anti-CTLA4-T responses|||participants|||Number
1290403|NCT00122382|Primary|Number of Participants With Serious Adverse Events Reported During the Open-Label Period|SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.|||participants|||Number
1290404|NCT00122382|Primary|Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.|||participants|||Number
1290405|NCT00122382|Primary|Mean Change From Baseline in Radiographic Total Score to Month 12|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 12|The analysis was intent-to-treat. Because the analysis was change from baseline, only those with baseline and post-baseline were included. Linear extrapolation imputation was applied.|||units on a scale||Standard Deviation|Mean
1290406|NCT00122382|Primary|Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12|Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.|Month 12|Intent to treat = all randomized and treated subjects. Those with missing data post-discontinuation were considered non-responders.|||participants|||Number
1290407|NCT00122382|Secondary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)|Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).|includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.|Treated participants in the double-blind period who were evaluated for anti-abatacept or anti-CTLA4-T responses|||Participants|||Number
1290408|NCT00122382|Secondary|Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). The joint space narrowing score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value|Baseline, Month 12|Intention-to-Treat - linear extrapolation imputation. Analysis of change from baseline restricts subjects included in to the analysis to those with baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
1290409|NCT00122382|Secondary|Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12|The SF-36 covers 8 health dimensions: 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from 0 to 100, with a higher score indicating better quality of life. Two summary scores (physical and mental component summaries) were produced taking a weighted linear combination of the 8 individual subscales. Change from Baseline=Post-baseline - Baseline value; adjusted for baseline value.|Baseline, Month 12|Last Observation Carried Forward (LOCF) Intent to Treat population = all randomized and treated. As change from baseline analysis, only those with baseline and post-baseline included.|||units on a scale||Standard Error|Mean
1290410|NCT00122382|Secondary|Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12|Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.|||participants|||Number
1290411|NCT00122382|Secondary|Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12|DAS 28-CRP is a continuous variable that is a composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, CRP in milligrams/Liter (mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 to 10, indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1=high disease activity; <3.2=low disease activity; <2.6=remission. Change from Baseline=Post-baseline - Baseline value; Adjusted for baseline value.|Baseline, Month 12|Last Observation Carried Forward (LOCF) Intent to Treat population = all randomized and treated. As change from baseline analysis, only those with baseline and post-baseline included.|||units in a scale||Standard Error|Mean
1290412|NCT00122382|Secondary|Number of Participants With Major Clinical Response (MCR) at Month 12|MCR was defined as 6 months of consecutive ACR 70 response at Month 12. ACR 70, the American College of Rheumatology (ACR) definition of 70% improvement was based on a 70% improvement (compared to baseline values) in tender and swollen joint counts and 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function, and 1 acute phase reactant value [ie, CRP]).|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.|||participants|||Number
1290413|NCT00122382|Secondary|Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12|ACR 50 response was defined as a 50% improvement from baseline to Month 12 in tender and swollen joint counts and 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function), and 1 acute phase reactant value [ie, CRP].|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.|||participants|||Number
1290414|NCT00122369|Primary|Time Trends of Pain Experience|Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported pain scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with pain scores reported between 0=no pain, and 10=worst possible pain. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.|0-110 min|Intent to Treat; patients undergoing breast biopsy|||logit slopes|||Number
1290415|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|110 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290416|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|100 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290417|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|90 min|Patients remaining on procedure table. (Please note that the data in the hypnosis group encompass 4 data points since one patient did not indicate her anxiety level at that time point).|||units on a scale||Inter-Quartile Range|Median
1290418|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|80 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290419|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|70 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290420|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|60 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290421|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|50 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290422|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|40 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290423|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|30 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290424|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|20 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290425|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|10 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290426|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|0 min|Intent to Treat; patients on procedure table. (Please note that the data in the empathy group encompass 81 data points since one patient did not indicate her pain level at that time point).|||units on a scale||Inter-Quartile Range|Median
1290427|NCT00122369|Primary|Time Trends of Anxiety Experience|Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported anxiety scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with anxiety scores reported between 0=no anxiety and 10=worst possible anxiety. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.|0-110 min|Intent to Treat; patients undergoing breast biopsy|||logit slopes|||Number
1290428|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|110 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290429|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|100 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290430|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|90 min|Patients remaining on procedure table (please note that the data in the hypnosis group encompass only 4 patients since the 5th patient did not indicate her anxiety level at that time point)|||units on a scale||Inter-Quartile Range|Median
1290431|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|80 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290432|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|70 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
1290439|NCT00122369|Secondary|Impact of Event Scale (IES-15)|"The IES is a measure of subjective distress for any specific life event. This 15-item self-report instrument is used to assess experiences of intrusive thoughts (Intrusion subscale) and attempts to consciously avoid such experiences (Avoidance subscale) that are commonly associated with subjective distress about life situations. Answers are given in four ratings from not at all (score 0) to often (score 5), with a possible TOTAL overall range of scores from zero to 75.~≥26 indicates moderate to severe distress) of women who at the time of return for breast surgery after their initial biopsy"|Patients were followed for up to 3 weeks after their biopsy until the time of their surgery|These 19 patients were the only ones who could be captured for their return to surgery after their initial biopsy.|||Scores on a Scale||Standard Deviation|Mean
1290440|NCT00122369|Secondary|Salivary Cortisol Secretion|Secretion of cortisol over time is customarily described in terms of a slope with the time of day of cortisol measurement as the x variable and the natural logarithm of the measured cortisol concentration as the y variable. Cortisol slope is expressed as the natural logarithm of cortisol (micrograms per deciliter) per hour, with 1g/dL corresponding to 27.8 nmol/L. In general, greater negative slopes (with steeper decreases from high morning values to low evening values) are considered better adapted and healthier than flatter (less negative) slopes.|Patients were followed for the 5 days following their breast biopsy|Women learned their diagnosis between Day 1 and 6 (mean day 2.4). Analysis was truncated at day 5 when sufficient numbers of patients for meaningful analysis were available in each group: 16 in the “known malignant” group, 37 in the “known benign” group, and 73 in the “uncertain group” totaling 126 patients.|||ln (microgram/dL)/hr||95% Confidence Interval|Mean
1290441|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety to 10=worst possible anxiety. Patients self-reported anxiety at the beginning (time 0), every 10 minutes, and at the end of their biopsy procedure on a 0-10 numeric verbal anxiety scale (0=no anxiety at all, 10=worst possible anxiety). Participants were followed for the duration of the biopsy procedure, an average of 43 min.|0 min|Intention to Treat; patients on procedure table|||units on a scale||Inter-Quartile Range|Median
1290442|NCT00122317|Secondary|Incidence of Thrombosis After Eculizumab Infusion|Thrombosis was defined as occurrence of major adverse vascular events|From time of first ever dose through last dose (up to 24 months of study treatment)||||Number of events per 100 patient-years|||Number
1290443|NCT00122317|Secondary|Quality of Life as Measured by FACIT-Fatigue Scale Change From Baseline|The FACIT-Fatigue scale is a collection of quality of life questionnaires pertaining to the management of fatigue symptoms due to a chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Patients score each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores range from 0 to 52, with higher score indicating better quality of life.|From time of first infusion through 24 months of study treatment||||units on a scale||Standard Deviation|Mean
1290444|NCT00122317|Secondary|Hemolysis as Measured by Change From Baseline in LDH Area Under the Curve||From time of first infusion through 24 months of study treatment||||U/L x Day||Standard Deviation|Mean
1290445|NCT00122317|Primary|Incidence of Treatment-emergent Adverse Events||From time of consent to a maximum of 2.5 years of study treatment||||Participants|||Count of Participants
1290446|NCT00122278|Secondary|Functional Disability at 24 Hours|No functional impairment within 24 hours of emergency department discharge|24 hours||||Participants|||Count of Participants
1290447|NCT00122278|Primary|Persistent Headache Pain Free at 24 Hours|Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge|24 hours||||Participants|||Count of Participants
1290448|NCT00122187|Primary|Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results|Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results|6 months|Sites that completed the intervention and post-intervention data collection were included in the analysis|||percent patients with GI consult+workup|||Number
1290449|NCT00122187|Primary|Percent of Patients Receiving GI Consult for FOBT+ Results|Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results|6 months|Sites that completed the intervention and post-intervention data collection were included in the analysis|||percent patients receiving GI consult|||Number
1290450|NCT00122135|Primary|Presence of Discussions About End of Life Care Goals/Wishes|Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes|immediate||||participants|||Number
1290451|NCT00122109|Secondary|PTSD Checklist-military Version (PCL-M)|Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.|Post-treatment (2 weeks following last treatment session)||||units on a scale||Standard Deviation|Mean
1290452|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|6-Month Follow Up||||units on a scale||Standard Deviation|Mean
1290453|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|3-Month Follow Up||||units on a scale||Standard Deviation|Mean
1290454|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|Post-treatment (2 weeks following last treatment session)||||units on a scale||Standard Deviation|Mean
1293657|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 3|Laboratory hematology monocytes|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
1290456|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|6-month Follow Up||||units on a scale||Standard Deviation|Mean
1290457|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|3-month Follow Up||||units on a scale||Standard Deviation|Mean
1290458|NCT00122109|Secondary|PTSD Checklist-military Version (PCL-M)|Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.|Baseline||||units on a scale||Standard Deviation|Mean
1290459|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|Post-treatment (2 weeks following last treatment session)||||units on a scale||Standard Deviation|Mean
1290460|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Index|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|Baseline||||units on a scale||Standard Deviation|Mean
1290461|NCT00121836|Secondary|Number of Participants With Marked Laboratory Abnormalities|The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in >= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.|until progressive disease or for up to 3 years|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.|||Participants|||Number
1290462|NCT00121836|Secondary|Premature Withdrawal From Study Due to Adverse Events|The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.|Throughout study|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.|||Participants|||Number
1290463|NCT00121836|Secondary|Number of Subjects With Adverse Events|"The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.~Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution."|Throughout study|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.|||Participants|||Number
1290464|NCT00121836|Primary|Overall Survival|Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death|approximately 505 days (Median Time to Death)|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.|||Days||95% Confidence Interval|Median
1290465|NCT00121810|Secondary|Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)|"Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization."|baseline, 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 123, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.|||percent change||Standard Deviation|Mean
1290502|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||percentage red blood cells||Standard Error|Mean
1290466|NCT00121810|Secondary|Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24|"Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization"|baseline 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 129; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.|||percent change||Standard Deviation|Mean
1290467|NCT00121810|Secondary|Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24|"Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization."|baseline, 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.|||percent change||Standard Deviation|Mean
1290468|NCT00121810|Secondary|Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24|"A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.~percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent."|Baseline to 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 24: MMF+sirolimus = 115, MMF+CNI = 105.|||percent change||Standard Deviation|Mean
1290469|NCT00121810|Primary|Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12|"The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.~percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent."|baseline to 12 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 12: MMF+sirolimus = 120, MMF+CNI = 111.|||percent change||Standard Deviation|Mean
1290470|NCT00121719|Other Pre-specified|Pharmacodynamic (PD) Biomarkers of Lenvatinib in Peripheral Blood Mononuclear Cells (PBMCs) and Tumor Samples|Blood samples were collected for isolation of Peripheral Blood Mononuclear Cells (PBMCs) immediately prior to the first dose and at 3 and 24 hours following the first dose of lenvatinib. The same collection schedule was repeated following the administration of lenvatinib on Day 29 (Cycle 2 Day 1). For participants in the food-effect pilot study blood samples were collected pre-dose, plus 3 hour and 24 hours PD samples were collected on Day 15 or Day 22. These participants were not required to give PD samples on Cycle 2 Day 1. Tumor tissue samples were collected from participants with tumors accessible to biopsy (optional study). Tissue samples were formalin-fixed then paraffin embedded according to a standard protocol. Once preclinical studies have identified possible PD biomarkers for the biological effect of lenvatinib in vivo, the samples taken from participants in this study are planned to be analyzed. No data was provided at this time.|Blood: Cycle 1 Day 1, Day 15, or Day 22, Cycle 2 Day 1 Tumor tissue: Screening and after at least one 28-day Cycle of study treatment|||||||
1290471|NCT00121719|Secondary|Effect of Food on Time to Maximum Concentration (Tmax) of Lenvatinib|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1, Day 15, and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.|||Hours||Full Range|Median
1290472|NCT00121719|Secondary|Effect of Food on the Maximum Plasma Concentration (Cmax) of Lenvatinib|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the mean and standard deviation for all participants and expressed in nanograms/milliliter (ng/mL).|Cycle 1 Day 1, Day 15 and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.|||ng/mL||Standard Deviation|Mean
1290503|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||g/dL||Standard Error|Mean
1290646|NCT00119678|Secondary|OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment|MSD technology was used to detect antibodies specific for CTLA4-T and for abatacept.|After the first dose of open-label period|Immunogenicity analysis population: participants who received abatacept and for whom baseline and at least one additional measurement during the open-label period were available.|||participants|||Number
1290473|NCT00121719|Secondary|Effect of Food on the Area Under the Curve From Zero to 24 Hours (AUC(0-24))|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-24), which was then summarized as the mean and standard deviation for all participants and expressed in nanograms*hours/milliliter (ng*hr/mL).|Cycle 1 Day 15 and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.|||ng*hr/mL||Standard Deviation|Mean
1290474|NCT00121719|Secondary|Renal Clearance (CLr) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Renal clearance was calculated as: Ae(0-24)/AUC(0-24) where Ae(0-24) is amount of unchanged lenvatinib recovered in 24 hours. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CLr, which was then summarized as the mean and standard deviation for all participants and expressed in liters/hour (L/hr).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||L/hour||Standard Deviation|Mean
1290475|NCT00121719|Secondary|Fraction of Unchanged Lenvatinib Excreted in the Urine (fe)|Urine aliquots were collected at 0 to 8, 8 to 16, and 16 to 24 hour intervals after administration of lenvatinib on Day 1 of Cycle 1 and Cycle 2, and then analyzed for the amount of lenvatinib using approved standardized methods. The samples were analyzed for the amount of lenvatinib in the urine using liquid chromatography-tandem mass spectrometry method of analysis. Urine PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of fe, which was then summarized as the mean and standard deviation for all participants and expressed in percentage of lenvatinib.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||Percentage of lenvatinib||Standard Deviation|Mean
1290476|NCT00121719|Secondary|Apparent Volume of Distribution (Vz/F)|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The apparent volume of distribution gives information about the amount of lenvatinib distributed in body tissue rather than the blood/plasma. Vz/F for parent lenvatinib only was calculated as Dose /[( λz)*( AUC0-inf)]. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Vz/F, which was then summarized as the mean and standard deviation for all participants and expressed in liters (L).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||L||Standard Deviation|Mean
1290477|NCT00121719|Secondary|Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. CL/F is the clearance for parent lenvatinib only and was calculated as Dose/[AUC0-inf]. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CL/F, which was then summarized as the mean and standard deviation for all participants and expressed in liters/hour (L/hr).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||L/hr||Standard Deviation|Mean
1290478|NCT00121719|Secondary|Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The area under the plasma concentration-time curve from time 0 to 24 hours, was calculated using the linear trapezoidal rule. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-24), which was then summarized as the mean and standard deviation for all participants and expressed in ng*hr/mL.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||ng*hr/mL||Standard Deviation|Mean
1290550|NCT00121485|Secondary|Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)|The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
1290683|NCT00119379|Secondary|Change in Limb Fat|Change in limb fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48||||limb fat (kg)||Inter-Quartile Range|Median
1290479|NCT00121719|Secondary|Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) was calculated as AUC(0-t) + Ct / λz where Ct is the last measurable concentration. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the mean and standard deviation for all participants and expressed in nanograms*hours/milliliter (ng*hr/mL).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||ng*hr/mL||Standard Deviation|Mean
1290480|NCT00121719|Secondary|Apparent Plasma Half-life (t1/2) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The apparent plasma half-life was calculated as t1/2 = 0.693/λz where the apparent first order elimination rate constant (λz) was determined by the slope of the terminal log-linear phase of the plasma concentration-time curve. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||Hours||Standard Deviation|Mean
1290481|NCT00121719|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||Hours||Standard Deviation|Mean
1290482|NCT00121719|Secondary|Maximum Plasma Concentration (Cmax) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma pharmacokinetics (PK) data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the mean and standard deviation for all participants and expressed as nanograms/milliliter (ng/mL).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.|||ng/mL||Standard Deviation|Mean
1290483|NCT00121719|Secondary|Best Overall Response (BOR)|BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of lenvatinib until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions. SD; PR failed to be achieved in the overall response assessment and there was no PD observed at 7 weeks or later after starting lenvatinib.|Baseline to first date of documented CR, PR, SD, or PD, assessed up to approximately 4 years|Intent-to-treat population included all participants who received at least one dose of lenvatinib.|||Percentage of participants|||Number
1290484|NCT00121719|Secondary|Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%|Treatment-related AEs were untoward medical events that were considered by the investigator to be possibly or probably related to lenvatinib.|First date of study treatment to date of withdrawal from study or last dose of study treatment, up to approximately 4 years|Safety population (ITT population) included all participants who took at least one dose of lenvatinib.|||Percentage of participants|||Number
1290485|NCT00121719|Secondary|Dose-limiting Toxicities (DLTs)|A DLT was defined as any grade 3 or higher hematological or non-hematological toxicity directly related to lenvatinib, any repeated National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 hematological or non-hematological toxicity considered to be directly related to lenvatinib and required dose reduction, or failure to administer greater than or equal to 75% of the planned dosage of lenvatinib during Cycle 1 as a result of treatment-related failure.|Cycle 1 (4 weeks) of each dose level|Intention to Treat (ITT)/Safety population included all subjects who received at least one dose of lenvatinib.|||Participants|||Number
1290551|NCT00121485|Secondary|Neurocognitive Assessments, Boston Naming Test|Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
1290486|NCT00121719|Secondary|Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs were collected from the signing of the informed consent form until the date the participant was withdrawn from the study. All AEs were graded on a 5-point scale according to the National Cancer Institute's Common Toxicity Criteria (NCI CTC) grading system, version 3.0. Safety was assessed using the occurrence of DLTs, AEs, SAEs, clinical laboratory test results, vital signs measurements, physical examination findings, and electrocardiograms (ECGs) readings. An AE was defined as any untoward medical occurrence in a participant administered lenvatinib and did not necessarily have a causal relationship to lenvatinib. An SAE was defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect. Treatment-related AEs and SAEs are AEs considered probably or possibly related to lenvatinib.|First date of study treatment to date of last dose of study treatment, up to approximately 4 years|Safety population (ITT population) included all participants who received at least one dose of lenvatinib.|||Percentage of participants|||Number
1290487|NCT00121719|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.|Cycle 1 (4 weeks)|Intent-to-treat population included all participants who received at least one dose of lenvatinib.|||mg|||Number
1290488|NCT00121667|Other Pre-specified|Confirmed Hypoglycemia During the ST + LT Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose <= 50 mg/dL and associated symptoms.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Treated participants|||participants|||Number
1290489|NCT00121667|Other Pre-specified|All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Treated participants|||participants|||Number
1290490|NCT00121667|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206,|Number of Participants Analyzed=Treated Participants; BL n=normal or abnormal ECG status at baseline of the cohort of participants with measure at given time point|||participants|||Number
1290491|NCT00121667|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||beats/min||Standard Error|Mean
1290492|NCT00121667|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
1290493|NCT00121667|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
1290494|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
1290495|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
1290496|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
1290497|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
1290498|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
1290499|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
1290500|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^9 c/L||Standard Error|Mean
1290633|NCT00120289|Secondary|Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months||||participants|||Number
1290504|NCT00121667|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period|||participants|||Number
1290505|NCT00121667|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|All treated participants|||participants|||Number
1290506|NCT00121667|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).|||mg*min/dL||Standard Error|Mean
1290507|NCT00121667|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24||Week 24|Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
1290508|NCT00121667|Secondary|Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).|||mg/dL||Standard Error|Mean
1290509|NCT00121667|Primary|Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized participants with both a baseline and post-baseline value (up to Week 24)|||percentage of glycosylated hemoglobins||Standard Error|Mean
1290510|NCT00121641|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point|||beats per minute||Standard Error|Mean
1290511|NCT00121641|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
1290512|NCT00121641|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
1290513|NCT00121641|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206|Treated participants; BL n=number of participants at baseline|||participants|||Number
1290514|NCT00121641|Other Pre-specified|Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort|'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|Treated participants|||participants|||Number
1290515|NCT00121641|Other Pre-specified|All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|Treated participants|||participants|||Number
1290516|NCT00121641|Other Pre-specified|Confirmed Hypoglycemia During ST + LT Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Treated participants|||participants|||Number
1290517|NCT00121641|Other Pre-specified|All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Treated participants|||participants|||Number
1290634|NCT00120289|Primary|Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.|Intention-to-treat|||participants|||Number
1290684|NCT00119379|Primary|Change in PBMC mtDNA|Peripheral blood mononuclear cell (PBMC) mitochondrial DNA (mtDNA), measured in copies/cell|Baseline to Week 48||||copies/cell||Inter-Quartile Range|Median
1290518|NCT00121641|Other Pre-specified|Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period|||participants|||Number
1290519|NCT00121641|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|All treated participants|||participants|||Number
1290520|NCT00121641|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206|Treated participants; BL n=number of participants at baseline|||participants|||Number
1290521|NCT00121641|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||beats per minute||Standard Error|Mean
1290522|NCT00121641|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
1290523|NCT00121641|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
1290524|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
1290525|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
1290526|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
1290527|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
1290528|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
1290529|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
1290530|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^9 c/L||Standard Error|Mean
1290531|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^6 c/µL||Standard Error|Mean
1290532|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||percentage red blood cells||Standard Error|Mean
1290533|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||g/dL||Standard Error|Mean
1290685|NCT00119379|Primary|Change in Fat mtDNA Content|Subcutaneous abdominal fat mitochondrial DNA (mtDNA)|Baseline to Week 48||||copies/cell||Inter-Quartile Range|Median
1290534|NCT00121641|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period|||participants|||Number
1290535|NCT00121641|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|All treated participants|||participants|||Number
1290536|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline||||kg/m^2||Standard Deviation|Mean
1290537|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline||||kg||Standard Deviation|Mean
1290538|NCT00121641|Other Pre-specified|Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline||||participants|||Number
1290539|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline||||years||Standard Deviation|Mean
1290540|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort||Baseline, Week 24|Open Label participants with measure at given time points, Last Observation Carried Forward (LOCF).|||mg*min/dL||Standard Error|Mean
1290541|NCT00121641|Primary|A1C Changes From Baseline at Week 24 - Open Label Cohort|To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.|Baseline, Week 24|Open-label participants with both a baseline and a post-baseline (up to Week 24)|||Percentage of glycosylated hemoglobins||Standard Error|Mean
1290542|NCT00121641|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort||Week 24|Open Label Participants with measurement at time point, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
1290543|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort||Baseline, Week 24|Open Label Subjects with Measurement at Timepoint; Last Observation Carried Forward (LOCF)|||mg/dL||Standard Error|Mean
1290544|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)||Baseline, Week 24|Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).|||mg*min/dL||Standard Error|Mean
1290545|NCT00121641|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24||Week 24|Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
1290546|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)||Baseline, Week 24|Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).|||mg/dL||Standard Error|Mean
1290547|NCT00121641|Primary|Hemoglobin A1c (A1C) Changes From Baseline at Week 24|To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.|Baseline, Week 24|Randomized participants with both a baseline and post-baseline value (up to Week 24).|||Percentage of glycosylated hemoglobins||Standard Error|Mean
1290548|NCT00121485|Secondary|Neurocognitive Assessments, Trail Making B|This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||Units measured in seconds||Full Range|Median
1290549|NCT00121485|Secondary|Neurocognitive Assessments, Trail Making A|This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||Units measured in seconds||Full Range|Median
1290552|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)|The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
1290553|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)|The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
1290554|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)|The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
1290555|NCT00121485|Secondary|Neurocognitive Assessments, Clock Drawing|Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
1290556|NCT00121485|Secondary|Reoperations|The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons|Patients were followed until outcome or up to 2 years post-implant, whichever came first||||percentage of participants|||Number
1290557|NCT00121485|Secondary|Functional Status (Patient Activity Score)|Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)|||percentage of participants|||Number
1290558|NCT00121485|Secondary|Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)|||Distance (meters)||Standard Deviation|Mean
1290559|NCT00121485|Secondary|New York Heart Association (NYHA) Classification|NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|Baseline, Months 1, 6, 12|Primary Study Cohort (As Treated)|||percentage of participants in each class|||Number
1290560|NCT00121485|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|KCCQ is a validated instrument to self assess quality of life including physical function and social function. Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life.|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)|||Units on a KCCQ score scale||Standard Deviation|Mean
1290561|NCT00121485|Secondary|Minnesota Living With Heart Failure Questionnaire(MLWHF)|MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life.|Baseline, Months 1,3,6,12|Primary Study Cohort (As Treated)|||Units on a MLWHF Score scale||Standard Deviation|Mean
1290562|NCT00121485|Primary|Composite Endpoint|Survival at two (2) years free of stroke, or reoperation to repair or replace the device|Patients' status at 2 years post-implant|Primary Study Cohort (Intent to Treat)|||percentage of participants||95% Confidence Interval|Number
1290563|NCT00121472|Secondary|Post-transplant Survival|30 day and 1 year post transplant survival|30 days, 1 year|Patients (n=112) who recieved a cardiac transplant were followed at 30 day and 1 year post-transplant to determine if the device influenced post-transplant survival.|||percentage of participants|||Number
1290564|NCT00121472|Secondary|Reoperations|Additional surgery after the initial implant operation|continuous|The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).|||Number of Events|||Number
1290565|NCT00121472|Secondary|Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|baseline to 6 months|Mean change from baseline in 6MWT distance at Month 1, 3, and 6. Only patients alive, capable and willing to perform test are included.|||meters||Standard Error|Mean
1297088|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 32||Baseline to Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1290566|NCT00121472|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHF)|MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.|Baseline to 6 months|Patients alive and capable of performing the test at 6 months|||units on a MLWHF Score scale||Standard Error|Mean
1290567|NCT00121472|Secondary|New York Heart Association (NYHA) Classification|NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|baseline, 1 month, 3 months, 6 months|All patients who survived to interval are included.|||units on NYHA scale||Full Range|Mean
1290568|NCT00121472|Secondary|Kansas City Cardiomyopathy Questionaire (KCCQ)|KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.|baseline to 6 months|Patients alive and capable of performing the test at 6 months|||Units on a KCCQ Score scale||Standard Error|Mean
1290569|NCT00121472|Secondary|Clinical Reliability (Malfunctions/Failures)|Confirmed malfunctions/Serious Adverse Events|continuous||||Number of Serious Events|||Number
1290570|NCT00121472|Primary|Survival|Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).|180 days|The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).|||participants|||Number
1290571|NCT00121238|Secondary|Mean Time to Progression of Prostate Cancer|Kaplan-Meier estimates of time to progression will be reported.|Up to 5 years|Patients were eligible if they had a histologic or cytologic diagnosis of prostate cancer with no evidence of metastatic disease or local progression on radiologic imaging and had 3 consecutive rising levels of prostate specific antigen (psa). Eligible patients who were treated on this trial were analyzed for survival|||months||95% Confidence Interval|Mean
1290572|NCT00121238|Secondary|Median Survival Time|6 of 13 patients were alive at five years. The Median survival time was calculated for all patients.|Up to 5 years||||months||95% Confidence Interval|Median
1290573|NCT00121238|Secondary|The Number of Participants With at Least One Incident of Toxicity|Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients (16 patients were enrolled however one progressed prior to treatment) including the two ineligible patients.|Up to 5 years|All treated patients, including 2 patients who were deemed ineligible for the study's endpoints to measure efficacy.|||participants|||Number
1290574|NCT00121238|Secondary|Median PSA Slope Difference|Median PSA slope difference was calculated between baseline and 6 months.|Baseline to 6 months||||ng/mL/month||Inter-Quartile Range|Median
1290575|NCT00121238|Primary|The Number of Patients With a PSA Decline of ≥50%|"To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer.~This measure defined as a drop in PSA of at least 50% from the final pre-treatment value."|Up to 5 years|Per protocol: of the 16 patients registered for this arm, 13 were analyzed. 1 patient lost eligibility due to disease progression, 2 others were censored from efficacy analysis because it was determined they were ineligible based on PSA requirements.|||participants|||Number
1290576|NCT00121225|Secondary|Effect of Vorinostat on Serum Levels of VEGF and b-FGF||Baseline, day 8 and day 15|||||||
1290577|NCT00121225|Secondary|Incidence of p53 Allelic Variations (72R or 72P)|Compared using Fisher’s exact test with response.|Baseline|||||||
1290578|NCT00121225|Secondary|Effect of Vorinostat on HP1 and macroH2A Nuclear Foci|Compared with Fisher’s exact test to determine utility as biomarkers of response.|Baseline and day 15|||||||
1290579|NCT00121225|Secondary|Time to Progression Assessed by RECIST||Up to 5 years|||||||
1290580|NCT00121225|Primary|Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)||Up to 5 years||||participants|||Number
1290581|NCT00121199|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1290582|NCT00121199|Primary|Progression-free Survival at 2 Year|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1290583|NCT00121199|Primary|Progression-free Survival at 1 Year|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-1 year|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1290686|NCT00119262|Secondary|Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab|The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post bevacizumab (the end of treatment). 158 patients who were treated and had baseline and end of treatment LVEF values were included in the analysis.|assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment||||percentage of participants||95% Confidence Interval|Number
1290584|NCT00121199|Secondary|Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.|All patients who started treatment were included in the analysis|||participants|||Number
1290585|NCT00121186|Primary|Overall Survival|OS rate at 1 year.|1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration||||participants|||Number
1290586|NCT00121186|Primary|Progression-free Survival|PFS rate at 1 year.|1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration||||participants|||Number
1290587|NCT00121173|Secondary|Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model|Number of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model|9 months||||Participants|||Count of Participants
1290588|NCT00121173|Secondary|Number of Participants With Correlated Measures of Immune Response With Clinical Response|Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV|9 months|All participants who received all 3 vaccinations|||Participants|||Count of Participants
1290589|NCT00121173|Secondary|Number of Participants With T-cell Immune Responses in the Blood|Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot)|41 weeks|all patients who completed all 3 vaccinations|||Participants|||Count of Participants
1290590|NCT00121173|Secondary|Regression of CIN3 Lesions|Number of participants with absence of CIN3 lesions at week 15|15 weeks|per protocol; participants who had no CIN3 lesions assessed by colposcopy and biopsy(ies) at the week 15 visit|||Participants|||Count of Participants
1290591|NCT00121173|Primary|Efficacy|The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy.|for the duration of the study, and whenever possible, for an additional 5 years|per protocol|||Participants|||Count of Participants
1290592|NCT00121173|Primary|Safety and Toxicity|Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.|for the duration of the study, and whenever possible, for an additional 5 years|per protocol|||Participants|||Count of Participants
1290593|NCT00121134|Primary|The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts||1 year||||percentage of participants|||Number
1290594|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
1290595|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
1290596|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
1290597|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
1290598|NCT00120874|Secondary|Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)|The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). The higher the score the worse the outcome.|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
1290688|NCT00119262|Primary|Congestive Heart Failure Rate|Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.|assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry|223 treated patients|||percentage of participants||95% Confidence Interval|Number
1290599|NCT00120874|Secondary|Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)|The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). Global rating was not analyzed for this study. The higher the score the worse the outcome.|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
1290600|NCT00120874|Secondary|Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)|"The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.~The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)"|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
1290601|NCT00120874|Primary|Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)|The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
1290602|NCT00120874|Primary|Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)|The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
1290603|NCT00120874|Secondary|Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)|"The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.~The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)"|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
1290604|NCT00120874|Secondary|Change From Baseline of the Mini-Mental State Examination (MMSE)|The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
1290605|NCT00120874|Secondary|Change From Baseline of the Mini-Mental State Examination (MMSE)|The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
1290606|NCT00120874|Secondary|Change From Baseline of the Severe Impairment Battery (SIB)|The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
1290607|NCT00120874|Secondary|Change From Baseline of the Severe Impairment Battery (SIB)|The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
1290608|NCT00120874|Primary|Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)|CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
1290609|NCT00120874|Primary|Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)|CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
1290610|NCT00120627|Post-Hoc|Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text Revision|Hyper-arousal Subscale (Criterion D) assesses symptoms of difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance, and exaggerated startle response. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Scores are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.|Pre-treatment to Post-treatment||||units on a scale||Standard Deviation|Mean
1290689|NCT00119158|Secondary|Change From Baseline in Patients' Self Assessment of Disease Severity (PSA) of Target Areas|"The patient or caregiver assessment of eczema severity (PSA) was recorded daily in a diary using a 0–4 scale similar to that of the IGA.(0 = clear,~1 = almost clear, 2 = mild disease, 3 = moderate disease,4 = severe disease).~Difference in value of PSA from baseline to end of study"|30 days|||||||
1290611|NCT00120627|Post-Hoc|Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text Revision|Avoidance (Criterion C) Subscale assesses symptoms of feeling detached and estranged from others; markedly diminished interest in significant activities; efforts to avoid thoughts, feelings, or conversations associated with the trauma; and efforts to avoid activities, places, or people that arouse recollections of the trauma. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 56, higher scores indicating greater levels of symptoms.|Pre-treatment and Post-treatment||||units on a scale||Standard Deviation|Mean
1290612|NCT00120627|Post-Hoc|Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text Revision|Re-experiencing Subscale (Criterion B) assesses symptoms of persistent re-experiencing of the traumatic event. This may include recurrent, intrusive recollections of the traumatic event; recurring dreams of the event; acting or feeling as if the traumatic event were occuring; and intense psychological distress at exposure to internal or external cues that symbolize or represent the event. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.|Pre-treatment to Post-treatment||||units on a scale||Standard Deviation|Mean
1290613|NCT00120627|Secondary|Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization|The Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.|Pre-treatment and Post-treatment||||units on a scale||Standard Deviation|Mean
1290614|NCT00120627|Primary|PTST Checklist (PCL) Civilian Version|"The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0=not at all to 5=extremely. Higher scores indicate greater severity and scores range from 17-85."|Pre-treatment and Post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
1290615|NCT00120627|Secondary|Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities|Quality of Life Enjoyment & Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.|Pre- & Post-Intervention|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing data, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
1290616|NCT00120627|Secondary|Mindfulness Attention Awareness Scale (MAAS)|The Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.|Baseline, Post-Intervention||||units on a scale||Standard Deviation|Mean
1290617|NCT00120627|Secondary|Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]|"FACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of feeling peaceful, having meaning and purpose in life and finding comfort in faith or spiritual beliefs. Items are rated on a 5-point Likert scale: 0 = not at all and 4 = very much. Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being."|Pre- & Post-Intervention|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
1290618|NCT00120627|Secondary|Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)|"Short-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include feeling calm and peaceful, having alot of energy, feeling downhearted and blue -- all rated on a frequency scale from 1= all of the time to 6=none of the time. Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) accomplishing less than you like and (2) not doing work or activies as carefully as usual (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements."|Pre-treatment and post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing values; a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
1290635|NCT00120250|Secondary|Clinician-Administered PTSD Scale (CAPS)|"The CAPS is a highly detailed measure of the presence and severity of the DSM-IV PTSD criteria. The severity score was calculated by adding up the frequency score (scale 0 = none of the time to 4 = most or all of the time) and an intensity score (scale 0 = none to 4 = extreme), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology. In this case, the total score for all 17 symptom questions, which is also the sum of the three symptom clusters, is used."|Week 3||||units on a scale||Standard Deviation|Mean
1290636|NCT00120250|Secondary|Total Sleep Time|Total Sleep Time was derived from a subject-completed daily sleep diary.|8 weeks||||Minutes||Standard Deviation|Mean
1290637|NCT00120250|Secondary|Sleep Latency|Sleep Latency was derived from a subject-completed daily sleep diary.|8 weeks||||Minutes||Standard Deviation|Mean
1290619|NCT00120627|Primary|Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR|"The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0=never to 4=daily or almost everyday. The items for intensity are rated from 0=none to 4=extreme. Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis.~The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms."|Pre-treatment and post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS for missing data; this is a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
1290620|NCT00120523|Secondary|Vital Signs and Physical Examinations: Pulse|Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.|||bpm||Standard Deviation|Mean
1290621|NCT00120523|Primary|Potential Effect on the Developing Immune System|number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.|throughout the 5-year study|Immune system function data analyses were performed on the immunology set (774 patients). Varicella titers were assessed for USA patients only (n= 104, n=108).|||% of patients with positive ab titer|||Number
1290622|NCT00120523|Secondary|Vital Signs and Physical Examinations: Blood Pressure (BP)|Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.|||mmHg||Standard Deviation|Mean
1290623|NCT00120523|Secondary|Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)|"PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US.~For the purposes of data presentation, a “Not True” response was coded a value of zero and a “True” a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient’s total score at the time point was set to missing."|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication. Patients who do not have baseline value are excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1290624|NCT00120523|Secondary|Body Surface Area Involved With Atopic Dermatitis|TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.|||percentage of TBSA affected||Standard Deviation|Mean
1290625|NCT00120523|Secondary|Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate|"IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100.~Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success."|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.|||percentage of participants||95% Confidence Interval|Number
1290626|NCT00120523|Primary|Growth Velocity (Weight)||throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.|||kg||Standard Deviation|Mean
1290627|NCT00120523|Primary|Growth Velocity (Height)||throughout the 5-year study|Safety/intent-to-treat (ITT) – all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.|||cm||Standard Deviation|Mean
1290628|NCT00120523|Primary|Safety Assessed by Adverse Events|crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period|throughout the 5-year study|complete safety/ITT population of experimental and control|||percentage of participants|||Number
1290629|NCT00120406|Primary|Primary Patency|Primary patency is defined as a Peak systolic velocity (PSV) ratio < 2.0 or angiographic percent diameter stenosis < 50%.|12 months||||Percentage of participants|Participants||Number
1290630|NCT00120406|Primary|Event-free Survival Rate|"Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6.~Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted."|12 months||||Percentage of participants|||Number
1290631|NCT00120289|Secondary|Cardiovascular Mortality||Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months.|Intention to treat|||participants|||Number
1290632|NCT00120289|Secondary|Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months|Intention to treat|||participants|||Number
1297089|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 24||Baseline to Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1290647|NCT00119678|Secondary|OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent|Total exposure to glucocorticosteroid was measured by the total prednisone or prednisone equivalent AUC. Based on the recommendation of the Data Monitoring Committee, the open-label, long-term extension period was terminated by the sponsor, for failure to meet the primary outcome measure for the double-blind period and because of an increase in SAEs in the abatacept treatment group. As such, these data were not analyzed.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||||||
1290648|NCT00119678|Secondary|OL; Total Number of BILAG A Flares Each Participant Experienced|Total number of BILAG A flares in any organ system after steroid tapering = new BILAG A features in any organ system. Scores defined as follows: None: participants with no BILAG A flare; 1: participants with 1 BILAG A flare or participants who discontinued without a new BILAG A flare were imputed as having one event. 2: participants with 2 BILAG A flares; 3 or >3: participants with 3 or more BILAG A flares.Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||||||
1290649|NCT00119678|Secondary|OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline|SLICC/ACR damage index:measure of cumulative damage due to SLE.Damage=non-reversible change occurring since onset of lupus,ascertained by clinical assessment & present for =>6 months.Scores of SLICC/ACR index:1:single episode;2:repeated episodes at least 6 months apart.Change in score from baseline to 1 year presented as:no change,increase 1 (an increase in score of 1),increase >1 (an increase in score of >1).Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365) and on Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||||||
1290650|NCT00119678|Secondary|OL; Number of Participants With a New SLE Flare|SLE flares scored using BILAG:A:presence of =>1 serious lupus features;B:more moderate features;C:mild symptomatic features;D:prior activity with no current symptoms due to active lupus;E:an organ that has never been involved.BILAG scores based on degrees of change in clinical features (1=improving,2=staying the same,3=worsening,4=new).New SLE flare means new BILAG A/B features in any organ system.Based on the recommendation of the Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||||||
1290651|NCT00119678|Secondary|DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment|Electrochemiluminescence (ECL) immunoassay based on Meso Scale Discovery (MSD) technology was used to detect antibodies specific for CTLA4-T and for abatacept.|From Day 1 to Day 365|Participants who received abatacept and for whom baseline and at least one additional measurement during double-blind period were available.|||participants|||Number
1290652|NCT00119678|Primary|OL; Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, red blood cells (RBC), white blood cells (WBC): >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; Glomerular filtration rate (GFR): <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: all treated participants who entered the OL period and received at least 1 dose of study medication. Where not evaluable was recorded for low (protein, glucose, blood, leukocyte esterase, RBC, WBC) or high(GFR) values and presented as 0. n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
1290653|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides|MAs are laboratory measurements marked as abnormal, as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where not evaluable was recorded for either low (cholesterol, triglycerides) or high (albumin) has been presented as 0. n = number of participants with evaluable results (each arm respectively)."|||participants|||Number
1290654|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95x LLN or >1.05x ULN (if pre-Rx<LLN, then <0.95x pre-Rx or >ULN. If pre-Rx >ULN, then >1.05x pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9x LLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN; Calcium (total): <0.8xLLN or >1.2xULN (if pre-Rx <LLN, then <0.75x pre-Rx or >ULN. If pre-Rx >ULN, then >1.25x pre-Rx or <LLN.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||participants|||Number
1290655|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where not evaluable was recorded for low values (ALP, AST, ALT, GGT, bilirubin, BUN, creatinine) and has been presented as 0."|||participants|||Number
1290656|NCT00119678|Primary|OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MMAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where not evaluable was recorded for either low(monocytes, basophils, eosinophils) or high(neutrophils) has been presented as 0."|||participants|||Number
1290657|NCT00119678|Primary|OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* lower limit of normal (LLN) or >1.5* upper limit of normal (ULN) (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where not evaluable was recorded for high values (hemoglobin, hematocrit, erythrocytes) and has been presented as 0. n = number of participants with evaluable results (each arm respectively)."|||participants|||Number
1290658|NCT00119678|Primary|OL; Number of Participants With Significant AEs of Special Interest|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs of particular importance were associated with the use of immunomodulatory agents. Number of participants with infections, malignant Neoplasms, pre-specified autoimmune disorders, acute-infusional AEs and peri-infusional AEs were recorded.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||participants|||Number
1290659|NCT00119678|Primary|Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs or SAEs: events with a relationship to the study therapy of certain; probable; possible; or missing.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||participants|||Number
1290660|NCT00119678|Secondary|DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings|Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated). Significant vital signs and physical examination findings are reported in the AE tables. Symptoms related to lupus were collected in British Isles Lupus Assessment Group (BILAG) assessments."||||||
1290661|NCT00119678|Secondary|DB; Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, RBC, WBC: >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* pre-Rx, or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; GFR: <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for low (protein, glucose, blood, leukocyte esterase, RBC, WBC) or high (GFR) values has been presented as 0. n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
1291340|NCT00113880|Secondary|Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)||Within 14 days of vaccination|Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age|||Percentage of FluMist recipients|||Number
1290662|NCT00119678|Secondary|DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dl or >220 mg/dl; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for either low or high values (albumin, cholesterol, triglycerides) has been presented as 0.n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
1290663|NCT00119678|Secondary|DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)|MAs are laboratory measurements marked as abnormal as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95* LLN or >1.05* ULN (if pre-Rx <LLN, then <0.95* pre-Rx or >ULN. If pre-Rx >ULN, then >1.05* pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9* LLN or >1.1* ULN (if pre-Rx <LLN, then <0.9* pre-Rx or >ULN. If pre-Rx >ULN, then >1.1* pre-Rx or <LLN; Calcium (total): <0.8* LLN or >1.2* ULN (if pre-Rx <LLN, then <0.75* pre-Rx or >ULN. If pre-Rx >ULN, then >1.25* pre-Rx or <LLN.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated).n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
1290664|NCT00119678|Secondary|DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for low values (all parameters) and has been presented as 0. n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
1290665|NCT00119678|Secondary|DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for either low(monocytes, basophils and eosinophils) or high values(neutrophils)has been presented as 0.n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
1290666|NCT00119678|Secondary|DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* LLN or >1.5* ULN (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for high values (hemoglobin, hematocrit and erythrocytes)has been presented as 0. n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
1290667|NCT00119678|Secondary|DB; Number of Participants With Significant AEs of Special Interest|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of special interest were associated with the use of immunomodulatory agents. Number of participants with infections, malignant neoplasms, pre-specified autoimmune disorders, acute infusional AEs and peri-infusional AEs were recorded.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated).Participants grouped for randomized treatments, except where different treatment taken for entire double-blind period (which will instead be presented by first treatment actually received)."|||participants|||Number
1290687|NCT00119262|Secondary|Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC)|The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post doxorubicin and cyclophosphamide (AC) Day 1 Cycle 5 (DIC5). 207 patients who were treated and had baseline and DIC5 LVEF values were included in the analysis.|assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment|Patients who were treated and had baseline and DIC5 LVEF values|||percentage of participants||95% Confidence Interval|Number
1293658|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 1|Laboratory hematology monocytes|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
1290668|NCT00119678|Secondary|DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs: events with a certain; probable; possible; or missing relationship to the study therapy. Participants who discontinued the study due to an AE were recorded.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated). The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match."|||participants|||Number
1290669|NCT00119678|Secondary|DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.|From start of study drug treatment to Day 365|All randomized and treated participants who were available for analysis, grouped by the treatment randomized to (ITT).|||participants|||Number
1290670|NCT00119678|Secondary|DB; Median Number of Days to the First Occurrence of a New SLE Flare|Elapsed days between start of corticosteroid taper & first day of flare.Scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of corticosteroid taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period|All randomized and treated participants, grouped by the treatment randomized to (ITT).|||Days||95% Confidence Interval|Median
1290671|NCT00119678|Secondary|DB; Total Number of New SLE Flares Each Participant Experienced|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to Day 365|All randomized and treated participants, grouped by the treatment randomized to (ITT).|||Participants|||Number
1290672|NCT00119678|Secondary|DB; Number of Participants With a New SLE Flare During the Initial 6 Months|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to 6 months.|All randomized and treated participants, grouped by the treatment randomized to (ITT).|||Participants|||Number
1290673|NCT00119678|Primary|Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved. Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to Day 365|All randomized and treated participants, grouped by the treatment randomized to (Intent to Treat [ITT]). Participants who were inception treatment failures were treated as having 1 new flare; participants who discontinued early without any new flares were treated as having 1 new flare.|||Participants|||Number
1290674|NCT00119405|Primary|Mitochondrial Function (mtDNA Levels)|Mitochondrial gene expression: mtDNA levels are used to quantify this outcome measure.|96 weeks||||copies per cell||95% Confidence Interval|Mean
1290675|NCT00119392|Secondary|Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.||At day +84||||Participants|||Count of Participants
1290676|NCT00119392|Secondary|Engraftment and Hematopoietic Toxicity|Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter.|At day +100||||days||Full Range|Median
1290677|NCT00119392|Secondary|Response Rates||Up to 8 years||||Participants|||Count of Participants
1290678|NCT00119392|Secondary|Overall and Progression-free Survival|Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.|Up to 8 years||||percent||95% Confidence Interval|Number
1290679|NCT00119392|Primary|Treatment Related Mortality (TRM)|Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.|At day +100||||percent||95% Confidence Interval|Number
1290680|NCT00119379|Secondary|Change in Hip Bone Mineral Density (BMD)|Change in hip bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48||||hip BMD, g/cm^2||Inter-Quartile Range|Median
1290681|NCT00119379|Secondary|Change in Lumbar Spine Bone Mineral Density (BMD)|Change in lumbar spine bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48||||lumbar spine BMD, g/cm^2||Inter-Quartile Range|Median
1290682|NCT00119379|Secondary|Change in Trunk Fat|Change in trunk fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48||||trunk fat (kg)||Inter-Quartile Range|Median
1290690|NCT00119158|Secondary|The Percentage of Target Areas Reaching a m-EASI (Modifed-Eczema Area Severity Index) Score of 2 or Less|"The EASI is a measure of Atopic Dermatitis (AD) severity. A m-EASI score (0–12) was also calculated as the sum of severity (0 = mild to 3 = severe) for four separate AD symptoms: erythema, infiltration ⁄population, excoriation and lichenification.~The percentage of participants whose eczema reaches almost clear"|up to one week|||||||
1290691|NCT00119158|Secondary|The Percentage of Target Areas Improved (i.e., Decrease in Localized Investigator Global Assessmet (l-IGA) Score From Baseline)|"The percentage of eczema areas that show improvement in l-IGA score.~The l-IGA were graded on a scale of 0–4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease)."|up to 15 days|||||||
1290692|NCT00119158|Secondary|The Percentage of Target Areas Reaching a l-IGA (Localized Investigator Global Assessment (l-IGA) or 0 or 1)|The Investigator Global Assessment (IGA) and l-IGA were graded on a scale of 0–4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe). The percentage of eczema lesions from the total population that reach almost clear|up to 15 days|||||||
1290693|NCT00119158|Secondary|The Time to the First Day When m-EASI is Scored by the Investigator as 2 or Less|Time to partial clearance of the localized eczema lesion assessed by the investigator is measured in days|up to one week|||||||
1290694|NCT00119158|Secondary|The Time to Clearance of the Disease|The time to clearance of eczema measured in days|assessed up to 30 days following drug application||||days||Standard Error|Mean
1290695|NCT00119158|Primary|Change From Baseline in the m-EASI (Eczema Area Severity Index) Score.|"Eczema Area severity index (EASI) is a composition of scores based on area of eczema involved, (0 = mild to 3 = severe) for four separate Atopic Dermatitis (AD) symptoms: erythema,infiltration ⁄population, excoriation and ichenification.~Total score 0-12"|up to 15 days|Analysis was per protocol, last observation carried forward|||units of a 0-12 scale||Standard Deviation|Mean
1290696|NCT00119041|Primary|A1c|Hemoglobin A1c is a measure of glycemic control|baseline and 18 months||||percentage of Hb that is glycosylated||Full Range|Mean
1290697|NCT00119041|Secondary|Patient Satisfaction|Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6. The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment. The total range of the DTSQ is the sum of the 6 individual questions scores (i.e. 0-36) Higher scores represent greater satisfaction/convenience.|Base line and at18 months.|The number subjects was determined on the size of the CBOC.|||units on a scale||Full Range|Mean
1290698|NCT00119015|Secondary|Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of other symptoms, including itchy nose/eyes and post-nasal drip, twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The other symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
1290699|NCT00119015|Secondary|Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of stuffy nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The stuffy nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
1290700|NCT00119015|Secondary|Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of runny nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The runny nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
1290701|NCT00119015|Secondary|Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of sneezing twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The sneezing symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
1290745|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|15 months||||participants||95% Confidence Interval|Number
1290702|NCT00119015|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period|"Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24.~The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
1290703|NCT00118911|Secondary|Maintenance of Gains in CBT Condition|maintenance of gains in CBT condition for those who responded or partially responded as measured by the ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.|12 month follow-up (12 months after baseline assessment)||||units on a scale of symptom severity||Standard Deviation|Mean
1290704|NCT00118911|Primary|Post-treatment ADHD Symptoms|ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.|post-treatment (after receiving 12 sessions of treatment)|Analysis was based on intent to treat. We used mixed-effect modeling which automatically imputes data using the slope up to the point of discontinuation.|||units on a scale of symptom severity||Standard Deviation|Mean
1290705|NCT00118898|Secondary|Change in Fasting Triglyceride Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||Inter-Quartile Range|Median
1290706|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Regimen Failure|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|At week 48 and 96|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||percentage of participants||95% Confidence Interval|Number
1290707|NCT00118898|Other Pre-specified|Number of Participants With Regimen Failure|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||participants|||Number
1290708|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Treatment Modification|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|At week 48 and 96|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||percentage of participants||95% Confidence Interval|Number
1290709|NCT00118898|Other Pre-specified|Number of Participants With Treatment Modification|Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||participants|||Number
1290710|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.|At week 48 and 96|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.|||percentage of participants||95% Confidence Interval|Number
1290711|NCT00118898|Other Pre-specified|Number of Participants With a Grade 3/4 Safety Event|Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.|Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.|||participants|||Number
1290712|NCT00118898|Primary|Time From Treatment Dispensation to Treatment Modification|Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||Weeks||95% Confidence Interval|Number
1290746|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|12 months||||participants||95% Confidence Interval|Number
1290713|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Virologic Failure|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.|At week 48 and 96|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.|||percentage of participants||95% Confidence Interval|Number
1290714|NCT00118898|Primary|Time From Treatment Dispensation to a Grade 3/4 Safety Event|Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.|||Weeks||95% Confidence Interval|Number
1290715|NCT00118898|Secondary|Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||Inter-Quartile Range|Median
1290716|NCT00118898|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||Inter-Quartile Range|Median
1290717|NCT00118898|Secondary|Change in Fasting Total Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||Inter-Quartile Range|Median
1290718|NCT00118898|Secondary|Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.|"AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.~http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm"|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.|||Participants|||Number
1290719|NCT00118898|Secondary|Number of Participants With Virologic Failure and Emergence of Major Resistance|Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.|||participants|||Number
1290720|NCT00118898|Secondary|Change in CD4 Count (Cells/mm3) From Baseline|Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).|At Weeks 48 and 96|Intention to treat: All participants with CD4 data were included, complete-case approach.|||Cells/mm3||Inter-Quartile Range|Median
1290721|NCT00118898|Secondary|Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL||At Weeks 48 and 96|Intention to treat: All participants with RNA data were included, complete-case approach.|||Participants|||Number
1290722|NCT00118898|Secondary|The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||At Weeks 48 and 96|Intention to treat: All participants with RNA data were included, complete-case approach.|||Participants|||Number
1290723|NCT00118898|Secondary|Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||Weeks||95% Confidence Interval|Number
1290724|NCT00118898|Other Pre-specified|Number of Participants With Virologic Failure|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.|||participants|||Number
1290725|NCT00118898|Other Pre-specified|Amount of Study Follow-up|Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.|Follow-up time was variable, median follow-up was 138 weeks|Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.|||Weeks||Inter-Quartile Range|Median
1290747|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|9 months||||participants||95% Confidence Interval|Number
1290726|NCT00118898|Primary|Time From Randomization to Virologic Failure|Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.|||Weeks||95% Confidence Interval|Number
1290727|NCT00118755|Secondary|Duration of Overall Clinical Response (CR or PR)|Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.|Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days|Intent-to-treat population|||Days to event||95% Confidence Interval|Median
1290728|NCT00118755|Secondary|Best Overall Clinical Response|"Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient’s overall best response was complete response (CR), partial response (PR) (CR and PR considered responders), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met."|Through follow-up phase: Approximate Median of 318 days|Intent-to-treat population|||Patients|||Number
1290729|NCT00118755|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death, for any cause.|Time to death (through follow-up phase): Approximate Median of 718 days|Intent-to-treat population|||Days||95% Confidence Interval|Median
1290730|NCT00118755|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).|Time to disease progression or death (through follow-up phase)|Intent-to-treat population|||Days||95% Confidence Interval|Median
1290731|NCT00118742|Secondary|Change From Baseline in Creatinine Clearance|Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation|6, 12, and 24 months posttransplantation|intent-to-treat population|||Percent change in creatinine CL (mL/min)||Standard Deviation|Mean
1290732|NCT00118742|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant|Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|24 months posttransplant|intent-to-treat population|||Mean percent change in GFR (mL/min)||Standard Deviation|Mean
1290733|NCT00118742|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant|Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|6 months posttransplant|intent-to-treat population|||Percent change in GFR (mL/min)||Standard Deviation|Mean
1290734|NCT00118742|Primary|Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant|Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|12 months posttransplant|intent-to-treat population|||Percent change in GFR (mL/min)||Standard Deviation|Mean
1290735|NCT00118703|Secondary|Number of Participants Based on Overall Evaluation of Response to Therapy|Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period.|Week 4 (Day 29) or Early Withdrawal|ITT Population. Only participants available at the specified time point were analyzed.|||Participants|||Number
1290736|NCT00118703|Secondary|Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)|The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value.|Baseline and up to Week 4|ITT population. Only participants available at the specified timepoint were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1290748|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|6 months||||participants||95% Confidence Interval|Number
1290964|NCT00117572|Secondary|Quality of Life (FACT H&N)|FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)|Change from baseline to 1 year (1 year-pre)|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
1290737|NCT00118703|Primary|Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)|The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian [PM] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.|Baseline and up to Week 4|Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of study drug. Only participants present at the specified time point were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1290738|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|18 months||||participants||95% Confidence Interval|Number
1290739|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|15 months||||participants||95% Confidence Interval|Number
1290740|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|12 months||||participants||95% Confidence Interval|Number
1290741|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|9 months||||participants||95% Confidence Interval|Number
1290742|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|6 months||||participants||95% Confidence Interval|Number
1290743|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|3 months||||participants||95% Confidence Interval|Number
1290744|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|18 months||||participants||95% Confidence Interval|Number
1290749|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|3 months||||participants||95% Confidence Interval|Number
1290750|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|18 months||||participants||95% Confidence Interval|Number
1290751|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|15 months||||participants||95% Confidence Interval|Number
1290752|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|12 months||||participants||95% Confidence Interval|Number
1290753|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|9 months||||participants||95% Confidence Interval|Number
1290754|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|6 months||||participants||95% Confidence Interval|Number
1290755|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|3 months||||participants||95% Confidence Interval|Number
1290756|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|18 months||||participants||95% Confidence Interval|Number
1290757|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|15 months||||participants||95% Confidence Interval|Number
1290844|NCT00118053|Secondary|Disease-free Survival||10 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.||||||
1290845|NCT00118053|Secondary|Pathological Complete Response||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.||||||
1290758|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|12 months||||participants||90% Confidence Interval|Number
1290759|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|9 months||||participants||95% Confidence Interval|Number
1290760|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|6 months||||participants||95% Confidence Interval|Number
1290761|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|3 months||||participants||95% Confidence Interval|Number
1290762|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.|Baseline and 18 months||||units on a scale||95% Confidence Interval|Mean
1290763|NCT00118534|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.|Baseline and 15 months||||units on a scale||95% Confidence Interval|Mean
1290764|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.|Baseline and 12 months||||units on a scale||95% Confidence Interval|Mean
1290765|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.|Baseline and 9 months||||units on a scale||95% Confidence Interval|Mean
1290766|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.|Baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
1290767|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.|Baseline and 3 months||||units on a scale||95% Confidence Interval|Mean
1290768|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.|Baseline and 18 months||||units on a scale||95% Confidence Interval|Mean
1290769|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.|Baseline and 15 months||||units on a scale||95% Confidence Interval|Mean
1290770|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.|Baseline and 12 months||||units on a scale||95% Confidence Interval|Mean
1290771|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.|Baseline and 9 months||||units on a scale||95% Confidence Interval|Mean
1290772|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.|Baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
1290773|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.|Baseline and 3 months||||units on a scale||95% Confidence Interval|Mean
1290846|NCT00118053|Primary|Antitumor Activity as Measured by Response Rate||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.||||||
1297090|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 16||Baseline to Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1290774|NCT00118534|Secondary|Clinician Administered PTSD Scale (CAPS)|"Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was CAPS at 18 months. The range is 0-136; five rationally derived severity score ranges for interpreting CAPS total score have been proposed and are as follows: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology. A rationally derived 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change. The above severity ranges and 15-point marker are preliminary (Frank W. Weathers et. al., Clinician-administered PTSD Scale: A Review of the First Ten Years of Research, Depression and Anxiety 13: 132-156 (2001)). The results are reported in mean change from baseline."|Baseline and 18 months||||Units on a scale||95% Confidence Interval|Mean
1290775|NCT00118534|Secondary|Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months|A secondary outcome was self-reported 1-year prolonged abstinence between 6 and 18 months post-randomization. Prolonged abstinence excluded tobacco use prior to 6 months post-randomization to allow for initial treatment episode completion and recovery from early relapses. Prolonged abstinence defined non-abstinence as: 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks.|between 6 and 18 months||||participants|||Number
1290776|NCT00118534|Primary|Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization|The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine <100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.|between 6 and 18 months||||participants|||Number
1290777|NCT00118482|Secondary|Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.|Quality of life will be the third secondary outcome measure. The investigators will compare the quality of life in patients on fludrocortisone vs placebo|12 months|||||||
1290778|NCT00118482|Secondary|Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.||Within 12 months|||||||
1290779|NCT00118482|Secondary|The Frequency of Syncope Will be the First Secondary Outcome Measure.|Frequency will be reported as 12- month syncope event rates (%)|Within 12 months||||rate %||95% Confidence Interval|Mean
1290780|NCT00118482|Primary|The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.|This will be measured in terms of number of patients that had at least 1 syncopal spell in the 12 month follow up period.|Within 12 months||||Participants|||Count of Participants
1290781|NCT00118430|Secondary|Primary Care Visits||Measured at Year 1|The no treatment group did not have depression and was followed simply as a cohort and not part of the clinical trial. Therefore we did not measure this secondary outcome of primary care visits in the no treatment group.|||number of primary care visits||Standard Deviation|Mean
1290782|NCT00118430|Secondary|Graded Chronic Pain Scale Disability Score|This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)|Measured at Year 1||||units on a scale||Standard Deviation|Mean
1290783|NCT00118430|Primary|HSCL-20 Depression Severity|This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)|Measured at Year 1||||units on a scale||Standard Deviation|Mean
1290784|NCT00118430|Primary|Brief Pain Inventory Interference|The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).|Measured at Year 1||||units on a scale||Standard Deviation|Mean
1290785|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured after Phase 2 (Week 12) and Phase 3 (Week 24)||||Points on a scale||Standard Deviation|Mean
1290786|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured after Phase 1 (Week 6) and Phase 2 (Week 12)||||Points on a scale||Standard Deviation|Mean
1290787|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured at baseline and after Phase 1 (6 weeks)|Analyses in each study phase were for a modified intent to treat (ITT) sample, defined as all participants who had at least one on-treatment assessment during that phase.|||Points on a scale||Standard Deviation|Mean
1290847|NCT00118040|Secondary|pMAP Kinase in Tumor Tissue|"Detecting the signal of the biomarker, pMAP Kinase, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of pMAP Kinase strength signa|||Number
1290788|NCT00118404|Primary|Depressive Relapse/Recurrence or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)."|Measured at month 32|Intention to treat analysis|||% patients who relapsed/recurred|||Number
1290789|NCT00118404|Primary|Depressive Relapse/Recurrence or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)"|Measured at month 20|Intention to treat analysis|||% patients who relapsed/recurred|||Number
1290790|NCT00118404|Primary|Depressive Relapse or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)"|Measured at month 8|Intention to treat analysis|||% patients who relapsed|||Number
1290791|NCT00118378|Secondary|HIV RNA Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50-100,000 copies), this measure is presented in log10. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Log10 copies/mL||Standard Deviation|Mean
1290792|NCT00118378|Secondary|CD4 Cell Count|CD4 cell count is a laboratory marker providing an indication of immune functioning. Blood was drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >= 100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Cells/mcL||Standard Deviation|Mean
1290793|NCT00118378|Primary|Role Function Scale Outcome|The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50.|Measured at baseline and Week 4|The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.|||units on a scale||Standard Deviation|Mean
1290794|NCT00118378|Primary|Fatigue Severity Scale (FSS)|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.|Measured at baseline and Week 4|The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.|||units on a scale||Standard Deviation|Mean
1290795|NCT00118365|Secondary|Biomarker in Adenoma: Bcl-2|bcl-2 is the anti-apoptotic protein BCL2|At the end of the study, up to 3 years|The analysis cohort is based on the participants whose data are available.|||Adenoma|Participants||Number
1290796|NCT00118365|Secondary|Biomarker in Adenoma - p53|"Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates.~Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene."|At the end of the study|The analysis cohort is based on the participants whose data are available.|||percentage of cells that are positive||95% Confidence Interval|Mean
1290797|NCT00118365|Secondary|Biomarker in Adenoma: Sialyl-TN (B72.3)|sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation.|At the end of the study|The analysis cohort is based on the participants whose data are available.|||Adenoma|Participants||Number
1290798|NCT00118365|Secondary|Biomarker in Adenoma: CEA|carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation.|At the end of the study|The analysis cohort is based on the participants whose data are available.|||Adenoma|Participants||Number
1290799|NCT00118365|Secondary|Biomarker in Adenoma - Ki-67|Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates|At the end of the study|The analysis cohort is based on the participants whose data are available.|||percentage of cells that are positive||95% Confidence Interval|Mean
1290800|NCT00118365|Secondary|Biomarker in Adenoma: Apoptosis|Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained.|At the end of the study|The analysis cohort is based on the participants whose data are available.|||adenoma|Participants||Number
1290801|NCT00118365|Secondary|Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290802|NCT00118365|Secondary|At the End of the Study - Spermine Response by ODC Genotype|"Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290803|NCT00118365|Secondary|At the End of the Study - Spermidine Response by ODC Genotype|"Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290804|NCT00118365|Secondary|At the End of the Study - Putrescine Response by ODC Genotype|"Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290805|NCT00118365|Secondary|Baseline Spermine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.|||nmol/mg protein||Full Range|Median
1290806|NCT00118365|Secondary|Baseline Spermidine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.|||nmol/mg protein||Full Range|Median
1290807|NCT00118365|Secondary|Baseline Putrescine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.|||nmol/mg protein||Full Range|Median
1290808|NCT00118365|Secondary|Adverse Events With a Grade of 3 and Above|"Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other.~Per protocol, not all grade 3 events are considered as serious events."|Up to 36 months||||participants|||Number
1290809|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment|Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290810|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment|Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290811|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment|PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290812|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment|"The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort.~In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset.~The analysis cohort is based on the participants whose data are available and complete."|Up 36 months|In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290813|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment|The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.|Up 36 months|In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
1290814|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment|This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.|Up to 36 months|This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.|||participants|||Number
1290815|NCT00118365|Primary|Detection of Any Adenoma at the End of the Study|Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.|Up to 36 months|This analysis is based on the participants who had the end-of-study colonscopy procedure done.|||participants|||Number
1290816|NCT00118352|Secondary|Disease Progression/Relapse|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter’s transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|Up to 5 years||||percentage of participants|||Number
1290817|NCT00118352|Secondary|Immune Reconstitution|The outcome of immune reconstitution was not analyzed by the collaborating laboratory because only a small number of patients were only enrolled in Dose Level 1 (no alemtuzumab). The Dose Level 1 patients were going to be the baseline for which to compare the other patients on Dose Level 2 (and 3) who would have received alemtuzumab. The collaborating investigator determined that the study was not worthwhile performing based on this information.|Up to 1 year post-transplant|||||||
1290818|NCT00118352|Secondary|Incidence of Infection|Percentage patients that experienced infection(s).|Up to 5 years post-transplant||||percentage of participants|||Number
1290819|NCT00118352|Secondary|Incidence of Non-relapse Mortality|Percentage patient deaths due to non-relapse mortality|100 days after transplant||||percentage of participants|||Number
1290820|NCT00118352|Secondary|Incidence of High-dose Corticosteroid Utilization.|Percentage patients requiring steroids greater than 1 mg/kg.|100 days after transplant||||percentage of participants|||Number
1290821|NCT00118352|Secondary|Incidence of Graft Rejection|Percentage patients that experienced graft rejection.|84 days after transplant||||percentage of participants|||Number
1290822|NCT00118352|Primary|Incidence of Grade III-IV Acute GVHD|"Severity of Individual Organ Involvement~Liver:~Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin > 15mg/100ml~Gut:~Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall~Severity of GVHD~Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 2 to 4 liver involvement with or without a rash Grade IV - Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|100 days after transplant||||percentage of participants|||Number
1290823|NCT00118287|Primary|Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria|Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.|Up to 2 years||||Participants|||Count of Participants
1290824|NCT00118248|Secondary|Toxicity|Defined as the number of participants reporting grade 3 or higher adverse events that are classified as either possibly, probably, or definitely related to study treatment. Determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles)|All participants were evaluable for this endpoint.|||participants|||Number
1290825|NCT00118248|Secondary|Overall Survival|Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method.|Every 3 months until progression, and then every 6 months up to 3 years|All patients were evaluable for this endpoint.|||years||95% Confidence Interval|Median
1290826|NCT00118248|Secondary|Progression-Free Survival|Defined as the time from registration to the date of progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free. Estimated using the Kaplan-Meier method.|Every 3 months for up to 3 years|All participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
1290827|NCT00118248|Secondary|Overall Response|"The number of responses were categorized and summarized independently within each of the patient groups. Participants were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0.~Complete Response (CR): Disappearance of all lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Baseline, every 3 courses, and at the end of treatment study|All participants were evaluated for response.|||participants|||Number
1290848|NCT00118040|Secondary|MAP Kinase in Tumor Tissue|"Detecting the signal of the biomarker, MAP Kinase, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of MAP Kinase strength signal|||Number
1290828|NCT00118248|Primary|Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)|"The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free."|1 year|All patients were evaluable for this endpoint in this group.|||percentage of participants||90% Confidence Interval|Number
1290829|NCT00118157|Secondary|Changes in Phosphorylation in Tumor Tissue of Epidermal Growth Factor Receptor (EGFR), HER2, AKT Kinase, MAPK, ER-Ser118, and ER-SER167||Baseline and at 21 days|Data were not collected due to feasibility.||||||
1290830|NCT00118157|Primary|Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)||4 weeks||||participants||95% Confidence Interval|Number
1290831|NCT00118144|Secondary|Overall Survival|Overall Suvival using the product-limit method of Kaplan and Meier.|Up to 5 years||||Months||95% Confidence Interval|Mean
1290832|NCT00118144|Secondary|Progression-free Survival|Progression Free Survival using the product-limit method of Kaplan and Meier|Up to 5 years||||Months||95% Confidence Interval|Median
1290833|NCT00118144|Primary|Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.|A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.|Up to 5 years||||percentage of responders|||Number
1290834|NCT00118131|Secondary|Median Survival Time||10 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.|||months||95% Confidence Interval|Median
1290835|NCT00118131|Secondary|1-year Survival Rate||8 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.|||1-year survival rate (percentage)|||Number
1290836|NCT00118131|Secondary|Time to Progressive Disease||8 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.|||months||95% Confidence Interval|Median
1290837|NCT00118131|Primary|Overall Tumor Response Rate|Patients experiencing complete or partial response|7 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.|||Response rate (percentage)|||Number
1290838|NCT00118092|Secondary|Duration of PSA Response and PSA Control|"The distribution of this response duration will be estimated using the method of Kaplan-Meier. In patients whose PSA has declined from baseline by at least 30 %, “duration of PSA response” will be defined as the time from PSA response to time of progression. If a patient goes on to alternate therapy, they will be censored at the date they end treatment on this study. “Duration of PSA Control” is defined as the time from the date of the first 30% decline in PSA until an inflection point is identified. Inflection point is defined as the time to first consistent PSA increase, the point at which PSA began what becomes a continuous increase~> (retrospectively identified). The inflection point is the point at which disease control could assume to be lost."|From PSA response to time of progression, assessed up to 1 year|No participants with PSA response or PSA control.||||||
1290839|NCT00118092|Secondary|Disease-free Survival|Disease-free survival time is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had progressed at the time of their death. In patients who have achieved a PSA response, we will assess the time to PSA progression. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of disease-free survival time will be estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 3 years|All 15 eligible patients that started treatment were evaluated.|||months||95% Confidence Interval|Median
1290840|NCT00118092|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All 15 eligible patients that started treatment were evaluated.|||months||95% Confidence Interval|Median
1290841|NCT00118092|Secondary|Proportion of Overall Responses|"Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions.~The proportion of confirmed responses will be estimated by the number of patients with confirmed responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|Up to 3 years|All 15 eligible patients that started treatment were evaluated.|||percentage of responses||95% Confidence Interval|Number
1290842|NCT00118092|Primary|PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group|"Normalization: PSA ≤4.0 ng/ml. This must be confirmed by a second PSA value measured when patient returns in 4-6 weeks. This qualifies as a CR response. > > 50% decline: A 50% decline in PSA value from baseline which must be confirmed by a second PSA value measured when patient returns in 4-6 weeks later. This qualifies as a PR response. >~> Progression: A 25% or greater increase over baseline and an increase in the PSA level by at least 5 ng/mL, which is confirmed by a second value obtained approximately one week later. In addition, radiographic scans are required to confirm that a disease progression is by PSA only."|Up to 1 year|All 15 eligible patients that started treatment were evaluated.|||participants|||Number
1290843|NCT00118053|Secondary|Pathologic and Molecular Markers for Predicting Efficacy||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.||||||
1290849|NCT00118040|Secondary|pAKT in Tumor Tissue|"Detecting the signal of the biomarker, pAKT, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of pAKT strength signal|||Number
1290850|NCT00118040|Secondary|AKT in Tumor Tissue|"Detecting the signal of the biomarker, AKT, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of AKT strength signal|||Number
1290851|NCT00118040|Secondary|COX2 in Tumor Tissue|"Detecting the signal of the biomarker, COX2, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of COX2 strength signal|||Number
1290852|NCT00118040|Secondary|Activated Caspase 3 in Tumor Tissue|"Detecting the signal of the biomarker, Activated Caspase 3, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of Caspase 3 strength signal|||Number
1290853|NCT00118040|Secondary|Ki-67 in Tumor Tissue|"Detecting the signal of the biomarker, Ki-67, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of Ki-67 strength signal|||Number
1290854|NCT00118040|Secondary|EGFR in Benign Tissue|"Detecting the signal of the biomarker, EGFR, in the benign tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.|||percentage of EGFR strength signal|||Number
1290855|NCT00118040|Primary|pEGFR in Benign Tissue|"Detecting the signal of the biomarker, pEGFR, in the benign tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.|||percentage of pEGFR strength signal|||Number
1290856|NCT00118040|Secondary|EGFR Mutations in Tumor Tissue|"Detecting the signal of EGFR mutations in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of EGFR strength signal|||Number
1290857|NCT00118040|Secondary|Survivin in Tumor Tissue|"Detecting the signal of the biomarker, Survivin, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of Survivin strength signal|||Number
1290858|NCT00118040|Secondary|Survivin in Urine by Visit (pg/ml)|Detecting the mean amount of the biomarker Survivin in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 16 for this outcome.|||pg/ml||Standard Deviation|Mean
1290859|NCT00118040|Secondary|BLCA-4 in Urine by Visit|Detecting the mean amount of the biomarker BLCA-4 in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 17 for this outcome.|||pg/ml||Standard Deviation|Mean
1290860|NCT00118040|Primary|Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment|Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of pEGFR strength signal|||Number
1290861|NCT00117988|Primary|Number of Patients With Response|Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses.|Baseline to time to best response; Every 6 weeks|Analysis was intention to treat (ITT). All participants with baseline and at least one post baseline target lesion measurement were included.|||participants|||Number
1290862|NCT00117962|Other Pre-specified|Overall Survival|Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 4 years)||||months||95% Confidence Interval|Median
1290863|NCT00117962|Secondary|Number of Participants With Overall Tumor Response|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Overall tumor response is the total number of CR and PRs."|Duration of study until progression (up to 4 years)||||participants|||Number
1290864|NCT00117962|Secondary|Failure-free Survival|Failure-free survival (FFS) is the time from randomization to a failure event, defined as disease progression or death from any cause (which ever occurred first). The median FFS with 95% CI was estimated using the Kaplan-Meier method,|Time from randomization to failure (up to 4 years)||||months||95% Confidence Interval|Median
1290865|NCT00117962|Primary|18 Month Survival|Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.|18 months (from randomization)||||percentage of participants||95% Confidence Interval|Number
1290866|NCT00117949|Secondary|Liver Function Tests|The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 months||||participants|||Number
1290867|NCT00117949|Secondary|Time to 90% Reduction in Prostate-specific Antigen Levels|The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.|3 months|Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only one participant reached a 90% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).|||days||Full Range|Median
1290868|NCT00117949|Secondary|Time to 50% Reduction in Prostate-specific Antigen Levels|The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.|3 months|Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only two participants reached a 50% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).|||days||Full Range|Median
1290869|NCT00117949|Primary|Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days|"The number of participants suppressed for at least 28 days was defined as the estimated survival probability at time=Day 28."|28 days||||participants|||Number
1290870|NCT00117949|Secondary|Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days|Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.|3 months||||participants|||Number
1290871|NCT00117949|Secondary|Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).|Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.|1, 3, 7, 14, 21, 28, 42 days|Half participants in the 40 mg group were not castrated and the median was not calculated (no statistical anaylsis was made). Two participants out of 24 in the 80 mg, 1/24 in the 120 mg, and 3/24 in the 160 mg groups were not castrated. For the 160 mg group the 95% CI was non-estimable and no statistical anaylsis was made.|||days|||Number
1290872|NCT00117949|Primary|Time to Meet Insufficient Testosterone Response|Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.|3 months|Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days).|||days||Full Range|Median
1290873|NCT00117845|Secondary|Safety|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|72 months||||Participants|||Number
1290874|NCT00117845|Primary|Response Rate|Response rate is based on the number of patients who achieve either a complete response (CR) or partial response (PR) to therapy. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma. Partial response is reduction by >=50% of leukemia cell count or >=50% reduction is the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.|up to 12 months||||Participants|||Number
1290875|NCT00117806|Primary|Competitive Employment-Percentage of Participants With Competitive Employment|Employment outcomes during year 1 among those subjects obtaining competitive employment.|12 months||||percentage of participants||95% Confidence Interval|Number
1290876|NCT00117806|Primary|Competitive Employment-Participants With Competitive Employment|Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.|12 months||||Participants with competitive employment|||Number
1290878|NCT00117793|Secondary|Frustration (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. Frustration was assessed by frequency of occurrence and rating. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., least frustrating).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||units on a scale||Standard Deviation|Mean
1290879|NCT00117793|Secondary|Ambulation (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Ambulation scale queries the ability to walk in general, in close spaces, on stairs and ramps, in urban environments, and on slippery surfaces. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., easiest to walk on).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||units on a scale||Standard Deviation|Mean
1290880|NCT00117793|Secondary|Residual Limb Health (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Residual Limb Health scale examines: sweat, smell, volume changes, rashes, ingrown hairs, and blisters. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., most healthful).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||units on a scale||Standard Deviation|Mean
1290881|NCT00117793|Primary|Limb Pistoning|Limb pistoning is the change in the resultant distance between the prosthetic-side knee joint marker triad and the residual limb thigh triad measured using a 12-camera motion analysis system while subjects weighted and un-weighted their prosthesis standing in place.|Measurements were taken after wearing the study prosthesis for three weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||mm||Standard Deviation|Mean
1290882|NCT00117793|Primary|Activity Level|Total number of steps during a two week period ending in the fourth week for each study prosthesis (PIN and VASS).|Two weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||steps (in thousands)||Standard Deviation|Mean
1290883|NCT00117793|Primary|Limb Volume||Measurements were taken after wearing the study prostheses for three weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||liters||Standard Deviation|Mean
1290884|NCT00117715|Primary|Change in CYP1A2 Drug Metabolism Phenotype With Age|Concentrations of caffeine metabolites 5-Acetylamino-6-amino-3-methyluracil (AAMU), 1-methylxanthine (1MX), 1-methyluric acid (1MU), and 1,7-dimethyluric acid (17MU) are quantified in urine and used to estimate the activity of cytochrome P450 1A2 using the well established (AAMU+1MX+1MU)/1,7U ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. (AAMU+1MX+1MU)/1,7U ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.|||unitless ratio||Standard Deviation|Mean
1290885|NCT00117715|Primary|Change in CYP3A4 Drug Metabolism Phenotype With Age|Concentrations of dextromethorphan (DM) metabolites 3-hydroxymorphinan (3HM) and dextrorphan (DX) are quantified in urine and used to estimate the activity of cytochrome P450 3A4 using the well established 3HM/DX ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. 3HM/DX ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.|||unitless ratio||Standard Deviation|Mean
1290886|NCT00117715|Primary|Change in CYP2D6 Drug Metabolism Phenotype With Age|Concentrations of dextromethorphan(DM) and it's metabolite dextrorphan (DX) are quantified in urine and used to estimate the activity of cytochromes P450 2D6 using the well established DM/DX ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. DM/DX ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.|||unitless ratio||Standard Deviation|Mean
1290887|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 480 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 433 to 480|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 432 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290888|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 432 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 385 to 432|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 384 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290965|NCT00117572|Secondary|Quality of Life (McMaster)|McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)|Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
1290889|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 337 to 384|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 336 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290890|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 289 to 336|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 288 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290891|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 241 to 288|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 240 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290892|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 193 to 240|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 192 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290893|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 145 to 192|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 144 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290894|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 97 to 144|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 96 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290895|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 49 to 96|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 48 (ie, entered the open-label phase) were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290896|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 48, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1290897|NCT00117676|Secondary|Percentage of Participants With HBsAg Loss and/or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, 384, 432, and 480|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1290966|NCT00117572|Secondary|Quality of Life (Speech)|Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)|Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
1290898|NCT00117676|Secondary|Percentage of Participants With HBsAg Loss and/or Seroconversion to Anti-HBs at Week 96|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 96. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 96.|Baseline; Week 96|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
1290899|NCT00117676|Secondary|Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion Antibody to HBs (Anti-HBs) at Week 48|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed. The missing = failure approach was used.|||percentage of participants|||Number
1290900|NCT00117676|Secondary|Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||units per liter||Standard Deviation|Mean
1290901|NCT00117676|Secondary|Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||units per liter||Standard Deviation|Mean
1290902|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 432 and 480|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1290903|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1290904|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 96|ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1290905|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Week 48|ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline were analyzed; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1290906|NCT00117676|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 240|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1290907|NCT00117676|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 48|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1290919|NCT00117637|Secondary|Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period|Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|At the time of the analysis, only 45 subjects in Sorafenib 400/600 mg bid group and 58 in Interferon/Sorafenib 400 mg bid group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)|||participant s|||Number
1290908|NCT00117676|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||units on a scale||Standard Deviation|Mean
1290909|NCT00117676|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1290910|NCT00117676|Secondary|Percentage of Participants With Histological Response at Week 240|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1290911|NCT00117676|Secondary|Percentage of Participants With Histological Response at Week 48|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1290912|NCT00117676|Secondary|Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||log10 copies/mL||Standard Deviation|Mean
1290913|NCT00117676|Secondary|Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||log10 copies/mL||Standard Deviation|Mean
1290914|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480||Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added emtricitabine to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1290915|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384||Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1290916|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 96||Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
1290917|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48||Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1290918|NCT00117676|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48|"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40."|Baseline; Week 48|Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1290956|NCT00117598|Other Pre-specified|Time to Response|Time between the date of randomization and the first date of objective response for participants with a confirmed objective response.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT subset of participants with a confirmed objective response|||months||95% Confidence Interval|Median
1290920|NCT00117637|Secondary|Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period|Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|At the time of the analysis, only 95 subjects in Sorafenib 400 mg bid group and 89 in Interferon group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)|||participants|||Number
1290921|NCT00117637|Secondary|Time to Response According to the Investigator Assessment for the Second Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation) was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks||||months||Full Range|Median
1290922|NCT00117637|Secondary|Time to Response According to the Investigator Assessment for the First Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks||||months||Full Range|Median
1290923|NCT00117637|Secondary|Time to Response According to the Independent Radiological Review for the First Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 15 months later, assessed every 8 weeks||||months||Full Range|Median
1290924|NCT00117637|Secondary|Duration of Response According to the Investigator Assessment for the Second Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||Full Range|Median
1290925|NCT00117637|Secondary|Duration of Response According to the Investigator Assessment for the First Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||Full Range|Median
1290926|NCT00117637|Secondary|Duration of Response According to the Independent Radiological Review for the First Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 15 months later, assessed every 8 weeks||||months||Full Range|Median
1290927|NCT00117637|Secondary|Average of All Trough Plasma Concentrations|Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID).|From start of treatment of the first subject until 15 months later assessed every 4 weeks.|Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg or 600 mg BID) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.|||100*mg/L||95% Confidence Interval|Geometric Mean
1290928|NCT00117637|Secondary|Slope - Change in Trough Concentration/Cycle|Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID (bis in die, twice daily)) to assess any potential trends in trough concentration over time.|From start of treatment of the first subject until 15 months later assessed every 4 weeks.|Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.|||100*(mg/L/cycle)||95% Confidence Interval|Mean
1290929|NCT00117637|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||95% Confidence Interval|Median
1290930|NCT00117637|Secondary|Progression Free Survival According to the Investigator Assessment (Second Intervention Period)|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||95% Confidence Interval|Median
1290931|NCT00117637|Secondary|Tumor Response According to the Investigator Assessment for the Second Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||participants|||Number
1290957|NCT00117598|Other Pre-specified|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline up to 5 years|ITT|||months||95% Confidence Interval|Median
1291341|NCT00113880|Secondary|Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)||Within 2-3 days of vaccination|Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age|||Percentage of FluMist recipients|||Number
1290932|NCT00117637|Secondary|Tumor Response According to the Investigator Assessment for the First Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||participants|||Number
1290933|NCT00117637|Secondary|Tumor Response According to the Independent Radiological Review for the First Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 15 months later, assessed every 8 weeks||||participants|||Number
1290934|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290935|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290936|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290937|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290938|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290958|NCT00117598|Secondary|Percentage of Participants With Objective Response|Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT|||percentage of participants||95% Confidence Interval|Number
1290939|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290940|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290941|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290942|NCT00117637|Secondary|Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the Second Intervention Period|The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290943|NCT00117637|Secondary|Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the First Intervention Period|The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290944|NCT00117637|Secondary|Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period|The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290945|NCT00117637|Secondary|Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the First Intervention Period|The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290959|NCT00117598|Primary|Progression-Free Survival (PFS)|The period from randomization until disease progression, death or date of last contact.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Intent-to-Treat (ITT) Population: All randomized participants at time of primary analysis|||months||95% Confidence Interval|Median
1290960|NCT00117585|Primary|Orthostatic Hypotension at Discharge|Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension.|Last three blood pressures prior to discharge||||participants|||Number
1290946|NCT00117637|Secondary|Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period|"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8."|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290947|NCT00117637|Secondary|Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) After Intervention for the First Intervention Period|"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8."|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1290948|NCT00117637|Secondary|Disease Control (DC) According to the Investigator Assessment for the Second Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||participants|||Number
1290949|NCT00117637|Secondary|Disease Control (DC) According to the Investigator Assessment for the First Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||participants|||Number
1290950|NCT00117637|Secondary|Disease Control (DC) According to Independent Central Review for the First Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 15 months later, assessed every 8 weeks||||participants|||Number
1290951|NCT00117637|Secondary|Progression-free Survival (PFS) Based on Investigator Assessment for the First Intervention Period|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||95% Confidence Interval|Median
1290952|NCT00117637|Primary|Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 15 months later, assessed every 8 weeks||||months||95% Confidence Interval|Median
1290953|NCT00117598|Other Pre-specified|Time to Tumor Progression (TTP)|TTP: time from randomization to first documentation of objective tumor progression (including recurrence); censored at last valid tumor assessment.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT|||months||95% Confidence Interval|Median
1290954|NCT00117598|Other Pre-specified|Time to Failure (TTF)|TTF is defined as the time from randomization to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death (any cause).|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT|||months||95% Confidence Interval|Median
1290955|NCT00117598|Other Pre-specified|Duration of Response|Time from the first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented; censored at last valid tumor assessment.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT subset of participants who had a response|||months||95% Confidence Interval|Median
1290961|NCT00117572|Secondary|Quality of Life (McMaster)|McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)|Change from baseline to 1 year (1 year-pre)|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
1290967|NCT00117572|Secondary|Quality of Life (Normalcy of Diet)|Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)|Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
1290968|NCT00117572|Secondary|Quality of Life (FACT H&N)|FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)|Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
1290969|NCT00117572|Secondary|Failure Pattern (Distant Recurrence)|Percentage of patients with distant recurrence|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
1290970|NCT00117572|Secondary|Failure Pattern (Local/Regional Recurrence)|Percentage of patients with local/regional recurrence|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
1290971|NCT00117572|Secondary|Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause|Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
1290972|NCT00117572|Secondary|Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause|DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
1290973|NCT00117572|Primary|Overall Survival: Time From Randomization to Death From Any Cause|Survival rates over 6 years.|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
1290974|NCT00117559|Primary|BDI|"Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression~The Beck Depression Inventory (BDI; Beck & Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is “I do not feel sad.” The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, & Garbing, 1988). Cronbach’s alpha was high for the present sample at both time points (a = .91 and .90)."|8 weeks||||units on a scale||Standard Deviation|Mean
1290975|NCT00117338|Secondary|Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration|Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.|120 minutes|At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of total doses of Beta-Agonist (mg) endpoint.|||mg||Inter-Quartile Range|Median
1290976|NCT00117338|Secondary|Change in FEV1 After 15 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value|Baseline and 15 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Liters||95% Confidence Interval|Least Squares Mean
1290977|NCT00117338|Secondary|Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time-weighted average over) 30 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Liters||95% Confidence Interval|Least Squares Mean
1290978|NCT00117338|Secondary|Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time-weighed average over) 45 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Liters||95% Confidence Interval|Least Squares Mean
1290979|NCT00117338|Secondary|Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)|Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration.|120 minutes|Full Analysis Set (FAS). At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of treatment failure endpoint. Baseline FEV1 measurement was also required to assess this endpoint since it was included in the model.|||Participants|||Number
1290980|NCT00117338|Secondary|Change From Baseline in Modified Pulmonary Index [mPI] Score|"Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12.~The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use."|Baseline and 60 minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1291473|NCT00113425|Primary|Change From Baseline in Acne Severity at Week 10|The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.|Baseline and Week 10||||units on a scale||95% Confidence Interval|Mean
1290981|NCT00117338|Primary|Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration|Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time weighted average over) 60 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Liters||95% Confidence Interval|Least Squares Mean
1290982|NCT00117325|Secondary|Mean Scores Changes From Baseline as a Function of Time|The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days|RITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1290983|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip|The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1290984|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip|The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1290985|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip|The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1290986|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip|The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1290987|NCT00117325|Secondary|Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS|The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percent change in score||Standard Error|Least Squares Mean
1290988|NCT00117325|Secondary|Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS|The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percent change in score||Standard Error|Least Squares Mean
1290989|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS|The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1290990|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1290991|NCT00117325|Secondary|Number of Participants With Overall Evaluation of Response to Therapy|The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.|Up to 4 weeks|RITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1290992|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)|The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|Reduced ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1290993|NCT00117325|Primary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)|The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|Due to irregularities found during a compliance audit, a reduced intent-to-treat (RITT) population was defined which excludes two participants from one of the investigative sites.|||Score on scale||Standard Error|Least Squares Mean
1290994|NCT00117312|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS06) and the extension study (FE200486 CS06A).|||participants|||Number
1290995|NCT00117312|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS06) and the extension study FE200486 CS06A.|||participants|||Number
1290996|NCT00117286|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|5 years|The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.|||participants|||Number
1290997|NCT00117286|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|5 years|The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.|||participants|||Number
1291474|NCT00113425|Primary|Change From Baseline in Erythematous Macules at Week 10||Baseline and Week 10||||erythematous macules||95% Confidence Interval|Mean
1290998|NCT00117156|Post-Hoc|Delayed Pneumonia Toxicity Rate|Delayed pneumonia toxicity rate is the proportion of patients who experienced significant pneumonia toxicity defined as nocardia or pneumocystis jiroveci after completing therapy.|Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.|The analysis dataset is comprised of all treated patients.|||proportion of patients||95% Confidence Interval|Number
1290999|NCT00117156|Post-Hoc|Delayed Bone Marrow Toxicity Rate|Delayed bone marrow toxicity rate is the proportion of patients who experienced significant bone marrow toxicity defined as aplastic anemia or myelodysplastic syndromes (MDS) after completing therapy.|Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.|The analysis dataset is comprised of all treated patients.|||proportion of patients||95% Confidence Interval|Number
1291000|NCT00117156|Secondary|3.1-Year Overall Survival|3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry.|Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
1291001|NCT00117156|Secondary|3.1-Year Progression-Free Survival|3.1-year progression-free survival is the probability of patients remaining alive and progression-free at 3.1 years from study entry estimated using Kaplan-Meier methods. Disease progression was assessed per Cheson criteria (1999).|Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
1291002|NCT00117156|Primary|Objective Response Rate|Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).|Assessed after three- and six-cycles of therapy.|The analysis dataset is comprised of all treated patients.|||proportion of patients||95% Confidence Interval|Number
1291003|NCT00116857|Primary|Beck Depression Inventory-II|Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.|Measured at Baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
1291004|NCT00116844|Secondary|Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study|Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits.|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1291005|NCT00116844|Secondary|Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding|"The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical (no genital lesions)."|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||DNA copies per day||Standard Deviation|Mean
1291006|NCT00116844|Secondary|Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding|"The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical (no genital lesions)."|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||DNA copies per day||Standard Deviation|Mean
1291007|NCT00116844|Secondary|Number of Participants With no Shedding|"The number of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical (no genital lesions)."|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1291008|NCT00116844|Secondary|Mean Percent Days of Total HSV-2 Shedding|"The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical (no genital lesions). The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period."|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of days||Standard Deviation|Mean
1291475|NCT00113425|Primary|Change From Baseline in Open Comedones at Week 10||Baseline and Week 10||||open comedones||95% Confidence Interval|Mean
1291009|NCT00116844|Primary|Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2|Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.|Up to Day 60 of each treatment period (up to 160 days)|The intent-to-treat crossover (ITTC) population was defined as consisting of all participants who received at least one dose of investigational product and had at least one PCR swabbing result in each treatment period. Only those participants with data available at the indicated time points were analyzed.|||Percentage of days||Standard Deviation|Mean
1291010|NCT00116831|Secondary|Number of Other Cardiovascular Events|This was one of the secondary endpoints of the study.|Baseline to Month 21|Safety Population|||Number of events|||Number
1291011|NCT00116831|Secondary|Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)|This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.|Baseline to Month 21|Safety Population|||Participants|||Number
1291012|NCT00116831|Secondary|Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)|This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.|Baseline to Month 21|Safety Population|||Participants|||Number
1291013|NCT00116831|Secondary|Change From Baseline to Month 18 in LDL-c/HDL-c Ratio|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||ratio||Standard Error|Mean
1291014|NCT00116831|Secondary|Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||ratio||Standard Error|Mean
1291015|NCT00116831|Secondary|Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||Ratio||Standard Error|Mean
1291016|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Apoprotein B (apoB)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291017|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291018|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Triglycerides (TG)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291019|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291020|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in HDL-3|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291021|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in HDL-2|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291022|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291023|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Total Cholesterol (TC)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291024|NCT00116831|Secondary|Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18|It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Model Adjusted change based on ANCOVA: Log(value) - log(Baseline) = log(Baseline) + sex + region + treatment + prior OAD + cardiac procedure.|Baseline to Month 18|ITT Population with LOCF|||percent change|||Number
1291025|NCT00116831|Secondary|Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18|It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1)It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Ratio to baseline as %change mean (%) was used as the estimation parameter for both groups.|Baseline to Month 18|ITT Population with LOCF|||percent change|||Number
1291026|NCT00116831|Secondary|Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18|Changes in cardiovascular biomarkers from Baseline to Month 18, such as matrix metalloproteinase-9 (MMP-9). Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291027|NCT00116831|Secondary|Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18|Changes in cardiovascular biomarkers from Baseline to Month 18, such as high sensitivity C-reactive protein (hsCRP) . Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
1291028|NCT00116831|Secondary|Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18|From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||millimole/Liter (mmol/L)||Standard Error|Mean
1291029|NCT00116831|Secondary|Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18|From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD) + cardiac procedure + treatment x visit.|Baseline to Month 18|Intent-to-Treat (ITT) Population without Last Observation Carried Forward (LOCF). ITT population was defined as all participants in the study who were randomized and have at least one on-therapy value for an efficacy assessment.|||Percentage||Standard Error|Mean
1291030|NCT00116831|Secondary|Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)|||millimeters squared (mm2)||Standard Error|Mean
1291031|NCT00116831|Secondary|Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)|||millimeters squared (mm2)||Standard Deviation|Mean
1291032|NCT00116831|Secondary|Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)|||millimeters cubed (mm3)||Standard Error|Mean
1291033|NCT00116831|Secondary|Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)|||millimeters cubed (mm3)||Standard Deviation|Mean
1291034|NCT00116831|Secondary|Model Adjusted Change From Baseline in Normalized Atheroma Volume|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Error|Mean
1291035|NCT00116831|Primary|Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18|Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD).|Baseline to Month 18|IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.)|||percent (absolute change)||Standard Error|Mean
1291036|NCT00116831|Primary|Change From Baseline in Percent Atheroma Volume (PAV) to Month 18|The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.|Baseline to Month 18|IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.)|||percent (absolute change)||Standard Deviation|Mean
1291037|NCT00116831|Secondary|Change From Baseline in Normalized Atheroma Volume|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Deviation|Mean
1291038|NCT00116831|Secondary|Model Adjusted Change From Baseline in Vessel Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters square (mm2)||Standard Error|Mean
1291039|NCT00116831|Secondary|Model Adjusted Change From Baseline in Lumen Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters square (mm2)||Standard Error|Mean
1291040|NCT00116831|Secondary|Model Adjusted Change From Baseline in Atheroma Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters square (mm2)||Standard Error|Mean
1291041|NCT00116831|Secondary|Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18|Baseline to Month 18|IVUS Evaluable Population|||millimeters squared (mm2)||Standard Deviation|Mean
1291042|NCT00116831|Secondary|Model Adjusted Change From Baseline in Vessel Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Error|Mean
1291043|NCT00116831|Secondary|Model Adjusted Change From Baseline in Lumen Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Error|Mean
1291044|NCT00116831|Secondary|Model Adjusted Change From Baseline in Atheroma Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Error|Mean
1291045|NCT00116831|Secondary|Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Deviation|Mean
1291046|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 480 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 433 to 480|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 432 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291047|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 432 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 385 to 432|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 384 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291048|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 337 to 384|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 336 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291049|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 289 to 336|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 288 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291050|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 241 to 288|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 240 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291051|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 193 to 240|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 192 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291052|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 145 to 192|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 144 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291476|NCT00113425|Primary|Change From Baseline in Closed Comedones at Week 10||Baseline and Week 10||||closed comedones||95% Confidence Interval|Mean
1291053|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 97 to 144|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 96 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291054|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 49 to 96|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 48 (ie, entered the open-label phase) were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291055|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
1291056|NCT00116805|Secondary|Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, 384, 432, and 480|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1291057|NCT00116805|Secondary|Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Week 96|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
1291058|NCT00116805|Secondary|Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion at Week 48|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with available data were analyzed.|||percentage of participants|||Number
1291059|NCT00116805|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion to Anti-HBe at Week 96|HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 96. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 96.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set who were HBeAg-positive at baseline and with available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
1291060|NCT00116805|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss/Seroconversion at Week 48|HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 48. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set who were HBeAg-positive at baseline and with available data were analyzed.|||percentage of participants|||Number
1291061|NCT00116805|Secondary|Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||U/L||Standard Deviation|Mean
1291062|NCT00116805|Secondary|Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||U/L||Standard Deviation|Mean
1291063|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Weeks 432 and 480|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1291093|NCT00116753|Secondary|Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|12 or 13 months|ITT population.|||participants|||Number
1291064|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1291065|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Week 96|ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1291066|NCT00116805|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48|ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline were analyzed; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1291067|NCT00116805|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 240|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1291068|NCT00116805|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 48|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1291069|NCT00116805|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||units on a scale||Standard Deviation|Mean
1291070|NCT00116805|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1291071|NCT00116805|Secondary|Percentage of Participants With Histological Response at Week 240|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1291072|NCT00116805|Secondary|Percentage of Participants With Histological Response at Week 48|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1291073|NCT00116805|Secondary|Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||log10 IU/mL||Standard Deviation|Mean
1291074|NCT00116805|Secondary|Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||log10 IU/mL||Standard Deviation|Mean
1291075|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480||Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added emtricitabine to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
1291076|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384||Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1291077|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who discontinued study unless the discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
1291078|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48||Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1291079|NCT00116805|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48|"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40."|Baseline; Week 48|Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
1291080|NCT00116779|Secondary|Participants With Markedly Abnormal Changes in Vital Signs or Body Weight|Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.|Day 364|ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61|||participants|||Number
1291081|NCT00116779|Secondary|Number of Participants With Abnormal Total Bilirubin Values|Participants with abnormal total bilirubin values|Day 1 - 364|ITT population|||participants|||Number
1291082|NCT00116779|Secondary|Number of Participants With Abnormal Aspartate Aminotransferase Values|Participants with aspartate aminotransferase values that were above the normal range.|Day 1 - 364|ITT population|||participants|||Number
1291083|NCT00116779|Secondary|Number of Participants With Abnormal Alanine Aminotransferase Values|Participants whose alanine aminotransferase values were at levels above the normal range.|Day 1 through day 364|ITT population|||participants|||Number
1291084|NCT00116779|Secondary|Median Testosterone Levels at Various Days During the Study|Testosterone levels at baseline and days 1, 3, 7, 14 and 364|Baseline, Days 1,3,7,14,364|ITT population|||nanograms / milliliter||Full Range|Median
1291085|NCT00116779|Secondary|Median Luteinizing Hormone Levels at Various Study Timeframes|Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.|Baseline, Days 1, 3, 7, 14|ITT population|||international units / liter||Full Range|Median
1291086|NCT00116779|Secondary|Median Prostate-Specific Antigen Values at Various Study Timepoints|Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.|Baseline, Days 3, 14, 28, 84, 364|ITT population|||nanogram / milliliter||Full Range|Median
1291087|NCT00116779|Secondary|Median Di-Hydrotestosterone Levels At Various Study Timepoints|Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14|Baseline, Days 1, 3, 7, 14|ITT population|||picogram / milliliter||Full Range|Median
1291088|NCT00116779|Secondary|Days to Prostate-Specific Antigen Progression|Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.|Day 0 (post dose) to Day 364|ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.|||days||Full Range|Median
1291089|NCT00116779|Secondary|Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population|||days||Full Range|Median
1291090|NCT00116779|Primary|Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28|Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.|Day 28 - Day 364|ITT population of participants who completed the study and had a testosterone level of <=0.5 nanogram per milliliter at Day 28.|||participants|||Number
1291091|NCT00116779|Secondary|Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.|Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.|Day 3|ITT population|||participants|||Number
1291092|NCT00116779|Primary|Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364|Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364|Day 28 to Day 364|ITT population of patients who completed the study and had testosterone <=0.5 nanogram per milliliter at Day 28.|||participants|||Number
1291094|NCT00116753|Secondary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|12 or 13 months|ITT population.|||participants|||Number
1291095|NCT00116753|Secondary|Number of Participants With Testosterone <=0.5 ng/mL at Day 28|Figures in the table give number of participants with testosterone <=0.5 ng/mL 28 days after the initial dose of trial medication.|28 Days|Observed Cases in ITT population.|||participants|||Number
1291096|NCT00116753|Secondary|Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study|Figures in the table give the number of participants with all testosterone values <=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.|From after Day 28 to 12 or 13 months|Observed Cases in ITT population.|||participants|||Number
1291097|NCT00116753|Primary|Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study|Figure in the table give the number of participants with all testosterone values <=0.5 ng/mL from Day 28 to the end of the study.|From Day 28 to 12 or 13 months|Observed Cases in ITT population.|||participants|||Number
1291098|NCT00116688|Secondary|Patient Global Assessment|The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.|Week 1 and Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
1291099|NCT00116688|Secondary|Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The EQ-5D VAS records the respondent’s self-rated health status on a vertical graduated (0-100) visual analogue scale. Higher EQ-5D VAS scores represent better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
1291100|NCT00116688|Secondary|Change From Baseline in Euroqol-5D (EQ-5D) Index Score|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
1291101|NCT00116688|Secondary|Change From Baseline in Short Form 36 (SF-36)|The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
1291102|NCT00116688|Secondary|Change From Baseline in ITP Patient Assessment Questionnaire|The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women’s Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
1291103|NCT00116688|Secondary|Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies|The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.|Duration of treatment (up to 277 weeks)|Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.|||Participants|||Number
1291104|NCT00116688|Secondary|Number of Participants With a Platelet Response|Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications.|Duration of treatment (up to 277 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||Participants|||Number
1291105|NCT00116688|Primary|Number of Participants With Adverse Events|Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.|Duration of treatment plus 8 weeks (up to 285 weeks)|Safety Analysis Set, composed of all participants who received at least one dose of romiplostim|||Participants|||Number
1291106|NCT00116649|Secondary|Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count|Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count|At Month 18|The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit|||percent reduction||Standard Deviation|Mean
1291122|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Head Circumference|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
1291477|NCT00113425|Primary|Change From Baseline in Cysts at Week 10||Baseline and Week 10||||cysts||95% Confidence Interval|Mean
1291107|NCT00116649|Primary|Number of Participants Who Experienced an Adverse Event|Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.|from first dose up to 18 months|There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication.|||participants|||Number
1291108|NCT00116428|Secondary|Percentage of Subjects Responded to Each of the Four Health Status Categories.|At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.|During the two years of post procedure|Subjects who completed the two-year health survey.|||Percentage of Participants|||Number
1291109|NCT00116428|Secondary|Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.|At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.|During the two years of post procedure|Subjects who completed two years follow up|||Percentage of Participants|||Number
1291110|NCT00116428|Secondary|The Percentage of Subjects Who Achieved Acute Success.|Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.|90 days post study procedure|This analysis population is based on the first study ablation procedure.|||Percentage of participants|||Number
1291111|NCT00116428|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis,diaphragmatic paralysis, atrio-esophageal fistula,transient ischemic attack,stroke,cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade,pericardial effusion,pneumothorax,atrial perforation,vascular access complications,pulmonary edema,hospitalization (initial and prolonged), and heart block.|Within 7 Days of Ablation Procedure|Analysis population includes those enrolled subjects undergoing a study ablation procedure. A total of 139 underwent the procedure, including 36 AAD (control) group subjects who underwent the procedure after failing the effectiveness endpoint. The remaining 25 AAD (control) subjects didn't have the ablation procedure.|||Percentage of Participants|||Number
1291112|NCT00116428|Primary|The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)|Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.|The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.||||Percentage of participants|||Number
1291113|NCT00116272|Secondary|Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)|"The ASQ-3 evaluates 5 domains of development: communication, gross motor, fine motor, problem solving, and personal-social. Each domain has a set of 6 items and parents rate the most appropriate answer for the presence of each skill: Yes,” “Sometimes,” “Not Yet,” with point values of 10, 5, or 0, respectively. Each domain question set is totaled independently and compared against statistically derived cutoffs that are set at 2 standard deviations below the mean. The percentage of infants below the cut-off or close to the cutoff (borderline) is reported."|1 year after birth|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, where data were available.|||Percentage of infants|||Number
1291114|NCT00116272|Secondary|Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age||From birth to 1 year|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).|||Percentage of infants|||Number
1291115|NCT00116272|Secondary|Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year||From birth to 1 year|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).|||Percentage of infants|||Number
1291116|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
1291117|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Length|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
1291118|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Weight|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
1291119|NCT00116272|Secondary|Postnatal Head Circumference Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available|||percentile||Standard Deviation|Mean
1291120|NCT00116272|Secondary|Postnatal Length Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available|||percentile||Standard Deviation|Mean
1291121|NCT00116272|Secondary|Postnatal Weight Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available|||percentile||Standard Deviation|Mean
1291202|NCT00115349|Secondary|Initiation of or Increase in Cardiac Medications||continuous|||||||
1291123|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Length|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
1291124|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Weight|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
1291125|NCT00116272|Secondary|Birth Head Circumference Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available|||cm||Standard Deviation|Mean
1291126|NCT00116272|Secondary|Birth Length Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available|||cm||Standard Deviation|Mean
1291127|NCT00116272|Secondary|Birth Weight Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available|||g||Standard Deviation|Mean
1291128|NCT00116272|Secondary|Gestational Age at Delivery (GAD) of Live Births||At birth|Live births in women enrolled and exposed to etanercept prior to 37 weeks’ gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), excluding multiple births.|||weeks||Standard Deviation|Mean
1291129|NCT00116272|Secondary|Percentage of Participants With Pre-term Delivery|A pretem delivery is defined as prior to 37 weeks gestation. Computed using Kaplan-Meier estimate at 37 weeks’ gestation, accounting for left truncation due to varying time in gestation at enrollment. Multiple births are excluded.|9 months|Participants enrolled and exposed to etanercept prior to 37 weeks gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), and excluding multiple births.|||percentage of participants||95% Confidence Interval|Number
1291130|NCT00116272|Secondary|Percentage of Pregnancies Ending in Spontaneous Abortion|Computed using Kaplan-Meier estimate at 20 weeks gestation, accounting for left truncation due to varying time in gestation at enrollment. In multiple pregnancies ending in at least 1 live-born infant, the live birth outcome is included in the analysis. In multiples ending in no live birth outcomes, the spontaneous abortion is counted as 1 event.|9 months|Participants enrolled and exposed to etanercept prior to 20 weeks gestation (Etanercept-Exposed) or enrolled prior to 20 weeks gestation (Diseased Controls).|||percentage of pregnancies||95% Confidence Interval|Number
1291131|NCT00116272|Secondary|Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects|A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). A pattern is defined as at least the same 3 specific minor malformations occurring in at least two infants in the exposed group.|From birth through 1 year of age|Children born to enrolled participants who received the dysmorphological exam. Includes multiples who received the exam for consideration of pattern; co-twins with the same 3 or more minor defects could not constitute a pattern on their own. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.|||percentage of infants|||Number
1291132|NCT00116272|Secondary|Percentage of Infants With Any 3 or More Minor Birth Defects|A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Children born to enrolled participants during the study who received the dysmorphological exam. Includes singletons and 1 randomly selected twin from twin pairs. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.|||percentage of infants|||Number
1291133|NCT00116272|Primary|Percentage of Infants With Major Birth Defects in All Pregnancies|A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Includes multiple pregnancies counted as 1 outcome; any 1 or more malformed infant counted as 1 major malformation in the numerator and 1 outcome in the denominator. Excludes 9 lost-to-follow-up in Etanercept-Exposed and 6 in Diseased Controls cohort. Only women exposed to etanercept in 1st trimester are included in the Etanercept-Exposed cohort.|||percentage of participants|||Number
1291134|NCT00116272|Primary|Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants|A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Includes multiple pregnancies ending in at least 1 live-born infant; any 1 or more malformed live-born infants counted as 1 major malformation outcome in the numerator, and 1 pregnancy outcome in the denominator. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.|||percentage of participants|||Number
1291135|NCT00116207|Secondary|Inflammation|High Sensitivity CRP (nmol/L)|24 months||||nmol/L||Standard Deviation|Mean
1291136|NCT00116207|Secondary|Systemic Oxidative Stress|ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection|24 months||||ng/G creatinine||Standard Deviation|Mean
1291137|NCT00116207|Secondary|Global Coronary Flow Reserve as a Measure of Endothelial Function|global myocardial blood flow reserve as a measure of endothelial function. Measured by PET using [13N]ammonia at rest and during adenosine stimulated coronary vasodilation.|Baseline, 24 months||||ratio (rest:stress)||Standard Deviation|Mean
1291203|NCT00115349|Secondary|Change in Holter Monitor Scores From Baseline to One Year.||one year|||||||
1291204|NCT00115349|Secondary|Change in ECHO LV Volume, Ejection Fraction, Shortening Fraction, and VCFc/Wall Stress Z-score From Baseline to One Year.||one year|||||||
1291205|NCT00115349|Secondary|Change in Left Ventricular (LV) Volume From Screening to One Year.||one year|||||||
1291138|NCT00116207|Primary|Global [11C]HED Retention Index (RI)|"Distal defects in [11C]meta-hydroxyephedrine ([11C]HED) retention involving at least 10 % of the left ventricle was used to define Cardiac Autonomic Neuropathy (CAN). The retention index (RI) is the unit of measure and is expressed as [11C]HEDblood min -1[ml tissue]-1~PET Data of Randomized Subjects at Baseline and 24-Months~The primary outcome was the change in the global [11C]HED RI = measure of cardiac innervation at 24 months in participants taking the active drug compared with those on placebo."|Baseline, 24 months||||Retention index||Standard Deviation|Mean
1291139|NCT00116168|Secondary|Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)|Vz/F of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Liters||Standard Deviation|Mean
1291140|NCT00116168|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Days||Standard Deviation|Mean
1291141|NCT00116168|Secondary|Total Body Clearance (CL)|CL of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Liter per day||Standard Deviation|Mean
1291142|NCT00116168|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Percent||Standard Deviation|Mean
1291143|NCT00116168|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528|AUC(0-infinity) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Microgram times day per milliliter||Standard Deviation|Mean
1291144|NCT00116168|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Micrograms times day per milliliter||Standard Deviation|Mean
1291145|NCT00116168|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Micrograms per milliliter||Standard Deviation|Mean
1291146|NCT00116168|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Days||Standard Deviation|Mean
1291147|NCT00116168|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 14, 28, 42, and 84|All subjects who received MEDI-528 (no safety or ADA information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Partial ADA information was available in the 0.3 mg/kg group (Day 0 and 14, n=5; Day 28, n=2; Day 42 and 84, n = 0)|||Participants|||Number
1291148|NCT00116168|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
1291149|NCT00116168|Primary|Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain|Number of participants with changes from baseline in the Day 28 MRI of the brain|Days 0 and 28|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
1291150|NCT00116168|Primary|Incidence of Clinically Significant Changes From Baseline in Neurologic Exam|Number of participants with clinically significant changes from baseline in neurologic exam|Days 0, 7, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
1291151|NCT00116168|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal|Days 0, 1, 7, 14, and 28|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
1291152|NCT00116168|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
1291153|NCT00115934|Secondary|Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|From Stage II Discharge to 14 Months of Age, an average of 8.9 months|These numbers reflect the number of patients who were discharged from the hospital after the Stage 2 procedure and were transplant-free.|||complications|||Number
1291206|NCT00115349|Secondary|Evaluate Whether L1/DFO Combination Therapy is Superior to DFO Monotherapy in Lowering Myocardial Iron Burden Estimated by Myocardial T2*.||one year|||||||
1291154|NCT00115934|Secondary|Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|From Norwood Discharge to Stage II discharge, an average of 4.2 months|These numbers reflect those patients who were discharged from the hospital after the Norwood procedure and were transplant free.|||complications|||Number
1291155|NCT00115934|Secondary|Complications: Total Number Experienced During Norwood Hospitalization|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|Norwood Hospitalization, an average of 36 days||||complications|||Number
1291156|NCT00115934|Secondary|Unintended Cardiovascular Interventional Procedures|Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.|From Randomization to 12 months||||procedures|||Number
1291157|NCT00115934|Secondary|Angiographic Findings: Right Pulmonary Artery Size|Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).|Measured pre-stage II surgery, on average 26 days prior to stage II palliation|These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.|||mm||Standard Deviation|Mean
1291158|NCT00115934|Secondary|Angiographic Findings: Left Pulmonary Artery Size|Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).|Measured pre-stage II surgery, on average 26 days prior to stage II palliation|These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.|||mm||Standard Deviation|Mean
1291159|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||Percentage of RV end-diastolic volume||Standard Deviation|Mean
1291160|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||Percentage of RV end-diastolic volume||Standard Deviation|Mean
1291161|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes used to calculate the ejection fraction.|||Percentage of RV end-diastolic volume||Standard Deviation|Mean
1291162|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
1291163|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
1291164|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
1291165|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
1291166|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
1291167|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or measures were not able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
1291168|NCT00115934|Secondary|Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial|This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.|From Randomization to the End of the Trial, an average of 32 months||||Participants|||Number
1291169|NCT00115934|Primary|Proportion of Patients Who Died or Received a Heart Transplant|The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.|Measured at 12 months|555 subjects were enrolled in the study; 5 of these subjects were excluded from analyses because a Norwood procedure was not performed; 1 subject was excluded because the subject withdrew before the 12-month follow-up, 12-month status was unknown. The data were analyzed on an intention to treat basis, subjects were analyzed as randomized.|||Participants|||Number
1291170|NCT00115869|Primary|Whether or Not Smoking Daily at 2 Years After High School|"Response (from the 2-years-after-high school questionnaire) Daily: 1 to 10 cigarettes a day, Daily: 11 to 20 cigarettes a day, Daily: more than a pack a day to the Item How often do you currently smoke cigarettes?"|2 years after high school||||participants|||Number
1291171|NCT00115869|Primary|Number of Participants Smoking Daily at 12th Grade|"Response 1 to 3 cigarettes per day, 4 to 10 cigarettes per day, 11 to 20 cigarettes per day, or More than 20 cigarettes per day to the Item How often do you currently smoke cigarettes?"|12th grade||||participants|||Number
1291172|NCT00115804|Secondary|Fibromyalgia Impact Questionnaire Modified for Children|A 19 item self-report instrument that measures overall impact of fibromyalgia including assessments of function, pain, fatigue, sleep quality, stiffness, anxiety and depression. Score range from 0 (no impact) to 100 (severe impact).|Over the past week.||||units on a scale||Standard Deviation|Mean
1291173|NCT00115804|Secondary|Multidimensional Anxiety Scale for Children|A 39-item self-report inventory that assesses four areas of anxiety symptoms (emotional, cognitive, physical, and behavioral). Score ranges from 0 (no anxiety symptoms) to 117 (severe anxiety symptoms).|Over the past week.||||units on a scale||Standard Deviation|Mean
1291174|NCT00115804|Secondary|Children's Depression Inventory|A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.|Over the past 2 weeks.||||units on a scale||Standard Deviation|Mean
1291175|NCT00115804|Secondary|The Functional Disability Inventory-parent Version|Consists of the same 15 items as the child version but allows the parent to provide their perception of the child's difficulty in performing daily physical, social, and recreational activities. The score ranges from 0 (no disability) to 60 (severe disability).|"Over the last few days."||||units on a scale||Standard Deviation|Mean
1291176|NCT00115804|Secondary|The Functional Disability Inventory-child Version|A self-report inventory that assesses patients' ability to perform a variety of daily physical, social, and recreational activities. The scale ranges from 0 (no disability) to 60 (severe disability).|"Over the last few days."||||units on a scale||Standard Deviation|Mean
1291177|NCT00115804|Secondary|The Patient Global Impression of Improvement|Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).|since baseline, at the time of the assessment||||units on a scale||Standard Deviation|Mean
1291178|NCT00115804|Secondary|The Clinical Global Impression of Severity|Measures severity of illness at the time of the assessment on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).|at the time of the assessment||||units on a scale||Standard Deviation|Mean
1291179|NCT00115804|Primary|Average Pain Severity Score|"The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire’s 100-mm visual analog scale.~(0=no pain and 100 = severe pain )"|Daily on average in the past week.|6 participants out of 10 screened met entry criteria. Two were terminated due to serious adverse events (SAEs).|||mm||Standard Deviation|Mean
1291180|NCT00115765|Secondary|Time to Treatment Failure (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum|Overall Study|Intention-to-Treat|||Month||95% Confidence Interval|Median
1291181|NCT00115765|Secondary|Time to Progression (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum|Overall Study|Intention-to-Treat|||Month||95% Confidence Interval|Median
1291182|NCT00115765|Secondary|Objective Tumor Response Rate (Irinotecan)|Best overall response of complete or partial response within irinotecan stratum|Overall Study|Intention-to-Treat|||Participant|||Number
1291478|NCT00113425|Primary|Change From Baseline in Pustule Acne Lesions at Week 10||Baseline and Week 10||||pustule acne lesions||95% Confidence Interval|Mean
1291183|NCT00115765|Post-Hoc|Objective Tumor Response Rate (Mutant KRAS)|Best overall response of complete or partial response in participants treated with irinotecan and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with irinotecan|||Participant|||Number
1291184|NCT00115765|Post-Hoc|Objective Tumor Response Rate (Wild-type KRAS)|Best overall response of complete or partial response in participants treated with irinotecan and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with irinotecan|||Participant|||Number
1291185|NCT00115765|Post-Hoc|Overall Survival (Mutant KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median.|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin|||Participant|||Number
1291186|NCT00115765|Post-Hoc|Overall Survival (Wild-type KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin|||Participant|||Number
1291187|NCT00115765|Post-Hoc|Progression-free Survival (Mutant KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin|||Month||95% Confidence Interval|Median
1291188|NCT00115765|Post-Hoc|Progression-free Survival (Wild-type KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin|||Month||95% Confidence Interval|Median
1291189|NCT00115765|Secondary|Progression-free Survival (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression|Overall Study|Intention-to-Treat|||Month||95% Confidence Interval|Median
1291190|NCT00115765|Secondary|Overall Survival (Irinotecan)|Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm.|Overall study|Intention-to-Treat|||Participant|||Number
1291191|NCT00115765|Primary|Objective Tumor Response Through Week 12 (Irinotecan)|Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum|Overall Study|Intention-to-Treat|||Participant|||Number
1291192|NCT00115765|Secondary|Time to Treatment Failure (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum.|Overall study|Intention-to-Treat|||Month||95% Confidence Interval|Median
1291193|NCT00115765|Secondary|Time to Progression (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum|Overall Study|Intention-to-Treat|||Month||95% Confidence Interval|Median
1291194|NCT00115765|Secondary|Objective Tumor Response Rate (Oxaliplatin)|Best overall response of complete or partial response within oxaliplatin stratum|Overall study|Intention-to-Treat|||Participant|||Number
1291195|NCT00115765|Secondary|Overall Survival (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin|Overall study|Intention-to-Treat|||Month||95% Confidence Interval|Median
1291196|NCT00115765|Primary|Progression-Free Survival (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression|Overall study|Intention-to-Treat|||Month||95% Confidence Interval|Median
1291197|NCT00115739|Secondary|6 Month Survival Rate|The percentage of patients still alive at 6 months was estimated.|6 months|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.|||percentage of patients||95% Confidence Interval|Number
1291198|NCT00115739|Secondary|6 Month Progression Free Survival Rate|The percentage of patients with 6 months progression-free survival was estimated. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, the appearance of new lesions, or the significant clinical deterioration related to progression of patient's disease.|6 months|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.|||percentage of patients||95% Confidence Interval|Number
1291199|NCT00115739|Secondary|Rate of Grade 3, Grade 4 and Grade 5 Toxicities Experienced by Patients With Anaplastic Thyroid Cancer Who Are Treated With Gleevec|Number of grade 3, grade 4 and grade 5 toxicities experienced by patients with anaplastic thyroid cancer who are treated with Gleevec.|Up to 30 days post treatment|Patients receiving at least one dose of imatinib were included in toxicity analysis.|||events|||Number
1291200|NCT00115739|Primary|Overall Response (Complete and Partial Response) Rate at 8 Weeks|The number of patients with Complete Response (CR), Partial Response (PR) and Stable Disease (SD) were determined at 8 weeks.|8 weeks|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.|||participants|||Number
1291201|NCT00115349|Secondary|Adverse Events||continous|||||||
1291207|NCT00115349|Primary|Change in Left Ventricular Ejection Fraction (LVEF).|The primary outcome variable is change in left ventricular ejection fraction (blood ejected from the heart into the body) as measured by MRI from baseline to one year. The unit of primary outcome (left ventricular ejection fraction) is the percent of the blood in left ventricle.|Baseline to one year||||Percent of the blood in left ventricle||Standard Error|Least Squares Mean
1291208|NCT00115297|Secondary|The Number of Participants Requiring Rescue Beta Agonist Use||Measured during the daytime||||participants|||Number
1291209|NCT00115297|Secondary|Wheezing at Day 7||Study day 7||||participants|||Number
1291210|NCT00115297|Primary|Number of Wheezing-free Days of Infant (Observed by Primary Caregiver)||First 56 days of study||||Days||Inter-Quartile Range|Median
1291211|NCT00115063|Secondary|Change in Duke Activity Status Index (DASI) Questionnaire Score|The DASI was used to access changes in fuctional capacity during the study. The highest score possible is 58.2 and the lowest is 0. The score for each individual question varied depending on the intensity of the activity being evaluated. The higher the score, the more physically active a person is to this set of activities of daily living questions.|Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||units on a scale||Standard Error|Mean
1291212|NCT00115063|Secondary|Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||mg/dL||Standard Error|Mean
1291213|NCT00115063|Secondary|Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||Percent change||Standard Error|Mean
1291214|NCT00115063|Secondary|Change in Blood Pressure||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||millimeter of mercury (mm Hg)||Standard Error|Mean
1291215|NCT00115063|Secondary|Change in Weight From Baseline in Kilograms (kg)||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||kg||Standard Error|Mean
1291216|NCT00115063|Primary|Percent Change From Baseline Weight||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||Percent change||Standard Error|Mean
1291217|NCT00114972|Secondary|The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)||5 Years|||||||
1291218|NCT00114972|Secondary|Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation||1 year, 3 and 5 years post allocation|||||||
1291219|NCT00114972|Secondary|Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation||1 month after procedure and 6 months, 1, 3 and 5 years post allocation|||||||
1291220|NCT00114972|Secondary|Freedom From MACCE and Its Components at 5 Years Post-allocation||5 years post allocation|||||||
1291221|NCT00114972|Primary|Repeat Revascularization (PCI and/or CABG).|Number of participants with repeat revascularization (PCI and/or CABG).|12 Months post enrollment||||Participants|||Number
1291222|NCT00114972|Secondary|Freedom From MACCE and Its Components at 3 Years Post-allocation||3 years post allocation|||||||
1291223|NCT00114972|Secondary|Freedom From MACCE and Its Components at 1 Year Post-allocation.|Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).|1 year post allocation||||participants|||Number
1291224|NCT00114972|Secondary|Individual Components of MACCE at 1 Year Post-allocation.|Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|1 year post allocation|ITT analysis|||participants|||Number
1291225|NCT00114972|Secondary|Individual Components of MACCE at 6 Months Post-allocation.|Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|6 months post allocation|ITT analysis|||Participants|||Number
1291226|NCT00114972|Secondary|Individual Components of MACCE at 1 Month Post-procedure.|Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|1 month after procedure|ITT analysis|||participants|||Number
1291227|NCT00114972|Secondary|Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.|Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.|1 month after procedure and 6 months, 3 years, and 5 years post allocation||||participants|||Number
1291228|NCT00114972|Primary|12-month Composite Safety Endpoint.|Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.|12 months after enrollment||||participants|||Number
1291229|NCT00114972|Primary|Primary Clinical Endpoint of 12-Month Binary MACCE.|Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).|12 months post enrollment|ITT analysis. Number of participants analyzed equals number of subjects who completed Overall Study, as listed in Participant Flow.|||participants|||Number
1291230|NCT00114959|Secondary|Participants With Complete Hematologic Remission Suppression of the Philadelphia Chromosome|"Complete hematologic remission was further classified according to the suppression of the Philadelphia chromosome (Ph) as:~No cytogenetic response - Ph positive 100% Minimal cytogenetic response - Ph positive 35-90% Partial cytogenetic response - Ph positive 1-34% Complete cytogenetic response - Ph positive 0%"|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.||||||
1291263|NCT00114634|Secondary|ABC Total Score|ABC total score includes all the questions from subscales, with range of 0 to 174. Higher the score , the greater the problem.|2 weeks||||units on a scale||Standard Error|Mean
1291231|NCT00114959|Primary|Number of Participants With Adverse Experiences (AEs)|"Summary of participants who had adverse events (AEs), who discontinued treatment due to the AE, who had serious adverse events (SAEs), and who had SAEs that were related to treatments.~A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:~Results in death;~Is life threatening;~Requires inpatient hospitalization or prolongation of existing hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Is medically important.~The Investigator assessed each AE for potential causal relationship between the event and study drug. An investigator assessment of possibly, probably or unknown relation is considered related."|up to 3 years|All treated participants|||participants|||Number
1291232|NCT00114959|Primary|Proportion of Participants With Chronic Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response|"Participants who are not in complete hematologic remission (CHR) at study start must achieve at least a CHR, and participants who are in CHR at onset must demonstrate an improvement in their cytogenetics.~A Complete Hematologic Remission (CHR) involves normalization of the bone marrow (less than 5% blasts) and peripheral blood with white blood cells < 10*10^9/L, absolute neutrophil count >=1*10^9/L, platelets >=100*10^9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease."|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.||||||
1291233|NCT00114959|Primary|Proportion of Participants With Accelerated Phase or Blast Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response|"Participants in accelerated or blast phase who converted to at least CML-chronic phase.~CML in accelerated phase meets one or more of the following criteria: >=15% - <30% blasts in peripheral blood or bone marrow, >=30% blasts + promyelocytes in peripheral blood or bone marrow, >=20% basophils in peripheral blood; platelet count <100*10^9/L unrelated to therapy or clonal evolution. CML in blast phase have >=30% blasts in the bone marrow or presence of extramedullary disease.~Meaningful responses include (in descending order of health)~Complete Hematologic Remission (CHR)~Partial Hematologic Remission (PHR)~Hematologic Improvement (HI)~Partial Response (PR)~Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts <15%, peripheral blasts and promyelocytes <30%, peripheral basophils <20%, and platelets >100*10^9/L."|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.||||||
1291234|NCT00114777|Secondary|Percentage of Participants With Graft Loss or Death to Month 84|Participant and graft survival at 84 months was summarized within each treatment group.|Randomization to date of death, up to 84 months|All randomized and transplanted participants|||percentage of participants|||Number
1291235|NCT00114777|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Month 84|All randomized and transplanted participants who completed 36 months of treatment and continued into long-term extension phase|||participants|||Number
1291236|NCT00114777|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Month 36|All randomized and transplanted participants|||participants|||Number
1291237|NCT00114777|Secondary|Number of Participants With Laboratory Test Abnormalities up to 36 Months|Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. Subjects were analyzed for Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase(AST), Hemoglobin, Platelet Count, Leukocytes, Bilirubin, Creatinine, Calcium, Bicarbonate, Potassium, Magnesium, Sodium, Phosphorus, Albumin, Uric Acid and Protein. Laboratory abnormalities were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.|Day 1 to Month 36|All randomized and transplanted participants.|||participants|||Number
1291238|NCT00114777|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months|Participants with abnormal blood pressure, body weight and body temperature outside the defined normal range were graded as clinically significant vital signs by the investigator.|Day 1 to Month 36|All randomized and transplanted participants|||participants|||Number
1291239|NCT00114777|Secondary|Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36|The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline = post-baseline value - baseline value; a higher value signifies improvement.|Baseline and Months 12, 24 and 36|Randomized and transplanted participants|||units on SF-36 scale||Standard Error|Mean
1291479|NCT00113425|Primary|Change From Baseline in Papule Acne Lesions at Week 10||Baseline and Week 10||||papule acne lesions||95% Confidence Interval|Mean
1291240|NCT00114777|Secondary|Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post­-transplantation and clinical suspicion of acute rejection exists.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants|||participants|||Number
1291241|NCT00114777|Secondary|Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Lymphocyte ­depletion therapy for treatment of an episode of acute was defined as a participant treated with therapy and provided not treated with steroids earlier while steroid resistant acute rejection was defined as participants initially treated with steroids alone for suspected acute rejection for at least 2 days and then followed by the start of lymphocyte ­depletion therapy.|Months 6, 12, 24 and 36|All randomized and transplanted participants|||participants|||Number
1291242|NCT00114777|Secondary|Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post­-transplantation and clinical suspicion of acute rejection exists.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1291243|NCT00114777|Secondary|Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36|Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants|||mg/dL||Standard Deviation|Mean
1291244|NCT00114777|Secondary|Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months|Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and non-elevated high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1291245|NCT00114777|Secondary|Mean Framingham Risk Score From Baseline to Months 12, 24 and 36|The risk score was calculated based on the total points from six variables: Age, Level of LDL-cholesterol, Level of HDL-cholesterol, Presence and severity of systolic or diastolic hypertension, Presence or absence of a history of diabetes mellitus and Presence or absence of a history recent cigarette smoking. Total scores can range from <-3 to >14, which translate to a 1% to 56% risk of developing coronary heart disease in 10 years. Totals in the 4 to 6 point range translate to a 7 to 11% risk and 8 to 10 point range translate to a 18 to 27% risk.|Baseline and Months 12, 24 and 36|All randomized and transplanted participants|||units on a scale||Standard Deviation|Mean
1291246|NCT00114777|Secondary|Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants|||mmHg||Standard Deviation|Mean
1291247|NCT00114777|Secondary|Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.|NODM was defined as participant who did not have diabetes prior to randomization. Participants were determined for NODM if the participant received an antidiabetic medication for a duration of at least 30 days, or at least two fasting plasma glucose (FPG) tests indicate that FPG is ≥ 126 mg/dL (7.0 mmol/L).|Months 12, 24 and 36|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1291248|NCT00114777|Secondary|Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or subject had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1291249|NCT00114777|Secondary|Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an antihypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Baseline and Months 12, 24 and 36|All randomized and transplanted participants|||participants|||Number
1291250|NCT00114777|Secondary|Change in Calculated GFR at Months 12, 24, 36 and 84|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Baseline and Months 12, 24, 36 and 84|All randomized and transplanted participants|||mL/min/1.73 m^2||Standard Deviation|Mean
1291251|NCT00114777|Secondary|Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants|||participants||Standard Deviation|Mean
1291252|NCT00114777|Secondary|Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant|Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss will be defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis.|Month 24 and Month 36 post-transplant|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1291253|NCT00114777|Secondary|Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12|Biopsy-proven CAN was determined by a blinded central histopathologist using the Banff 97 working classification of kidney transplant pathology. Onset of CAN was determined by the biopsy date when it was observed. Participants were considered as having CAN at 12 months if: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; Participant had graft loss during the first year post transplant; no biopsy available post 12 months and CAN not observed in biopsies prior to 12 months; no biopsy available either prior to or post 12 months; and the measured glomerular filtration rate from Month 3 to Month 12 decreases at least 10 mL/min/1.73m^2. All other participants with missing 12 month biopsy were considered having no CAN observed at 12 months.|At Month 12|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1291254|NCT00114777|Secondary|Measured Glomerular Filtration Rate (GFR) by Month 12 and 24|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here, ‘n’ signifies the number of evaluable participants for the reporting arm at the given time point. Missing measured GFR assessments were imputed to a GFR of zero.|At Month 12 and Month 24|All randomized and transplanted participants|||mL/min/1.73 m^2||Standard Deviation|Mean
1291255|NCT00114777|Primary|Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12|GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.|From Month 3 to Month 12|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1291256|NCT00114777|Primary|Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant|Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.|Month 12 post-transplant|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
1291257|NCT00114738|Secondary|Clinical Response|Clinical response is assessed by the response criteria for lymphomas and is defined as a fraction of patients who have a complete response (CR) or a complete response (CR) + partial response (PR). A complete response is disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g. lactate dehydrogenase) definitely assignable to the lymphoma. Partial response is ≥50% decreased in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen, ≥50% increase in the absolute number of circulating lymphocytes.|up to 22 weeks after initiation of therapy|Participants are grouped together in one arm/group because this is the arm/group in which all participants received drug.|||Percentage of patients|||Number
1291258|NCT00114738|Secondary|Count of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 143 months and 7 days|Participants are grouped together in one arm/group because most adverse events occurred during Part B, in which all participants received drug.|||Participants|||Count of Participants
1291259|NCT00114738|Primary|Overall Survival|Overall Survival is the time between the first day of treatment to the day of death. The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test.|up to 9.9 years||||Months||95% Confidence Interval|Median
1291260|NCT00114738|Primary|Overall Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression. Progression is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes, appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, appearance of new palpable hepatomegaly or splenomegaly that was not previously present, and ≥50% increase in the absolute number of circulating lymphocytes.|up to 9.9 years||||Months||95% Confidence Interval|Median
1291261|NCT00114738|Primary|Median Overall Survival (OS)|Overall Survival is the time between the first day of treatment to the day of death. The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test.|up to 9.9 years||||Months||95% Confidence Interval|Median
1291262|NCT00114738|Primary|Progression Free Survival (PFS)|Time interval from start of treatment to documented evidence of disease progression. Progression is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes, appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, appearance of new palpable hepatomegaly or splenomegaly that was not previously present, and ≥50% increase in the absolute number of circulating lymphocytes.The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test.|up to 5 years||||Months||95% Confidence Interval|Median
1291264|NCT00114634|Secondary|ABC Inappropriate Behavior Sub-scale|ABC Subscale V (Inappropriate speech) has 4 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 12.|2 weeks||||units on a scale||Standard Error|Mean
1291265|NCT00114634|Secondary|ABC Stereotypy Sub-scale|ABC Subscale III (Stereotypy) has 7 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 21.|2 weeks||||units on a scale||Standard Error|Mean
1291266|NCT00114634|Secondary|ABC Lethargy Sub-scale|ABC Subscale II (Lethargy) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree,2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48.|2 weeks||||units on a scale||Standard Error|Mean
1291267|NCT00114634|Secondary|ABC Irritability Sub-scale|ABC Subscale I (Irritability) has 15 items, each can be rated from 0 to 3, with 0 equal to not at all a problem, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 45|2 weeks||||units on a scale||Standard Error|Mean
1291268|NCT00114634|Primary|Hyperactivity Sub-scale of the Aberrant Behavior Checklist-Community (ABC-C).|The Aberrant Behavior Checklist-Community (ABC-C) is a measure used to identify treatment efficacy among intellectually impaired individuals. ABC Subscale IV (Hyperactivity) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, one the problem is the behavior but slight in degree, to the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48. The higher the score, the worse the hyperactivity. The comparison in this study was made between the blinded phases when patients received either egg yolk (treated, +cholesterol) or egg substitute (untreated, -cholesterol). Order was randomized.|2 weeks||||units on a scale||Standard Error|Mean
1291269|NCT00114530|Secondary|Time to Absolute Neutrophil Count Engraftment|Time to absolute neutrophil count (ANC) engraftment is defined as the number of days post-transplant until required levels of ANC are attained (for the mHSCT arm only). If engraftment did not occur within 28 days post-transplant, then the variable was set to 28 days. ANC engraftment required an ANC of > 500 cells/microliter, maintained for 3 consecutive days.|28 days post-transplant|Per-protocol (PP) – mHSCT arm only. The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm.|||Days||Full Range|Median
1291270|NCT00114530|Secondary|Number of Subjects With Infectious Complications|Infectious complications include any events that code to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class of “Infections and infestations” or events that a site has classified as an infectious event. These can include bacteremia, septicemia, fungemia, fever associated with infection, infectious pneumonia, idiopathic pneumonia syndrome, clinical infection (i.e. infection diagnosed with clinical features without identification of an organism) and other local/organ site-specific infections.|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.|||Participants|||Count of Participants
1291271|NCT00114530|Secondary|Infectious Complications|Infectious complications include any events that code to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class of “Infections and infestations” or events that a site has classified as an infectious event. These can include bacteremia, septicemia, fungemia, fever associated with infection, infectious pneumonia, idiopathic pneumonia syndrome, clinical infection (i.e. infection diagnosed with clinical features without identification of an organism) and other local/organ site-specific infections.|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.|||Events|||Number
1291272|NCT00114530|Secondary|Number of Subjects With Regimen-Related Toxicities|Regimen-related toxicities are defined as Grade 3 or higher adverse events reported by site physicians as possibly, probably, or definitely related to study therapy.|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.|||Participants|||Count of Participants
1291273|NCT00114530|Secondary|Regimen-Related Toxicities|Regimen-related toxicities are defined as Grade 3 or higher adverse events reported by site physicians as possibly, probably, or definitely related to study therapy.|Randomization through end of study follow-up (up to Month 72 post-randomization)|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.|||Events|||Number
1291281|NCT00114530|Secondary|New or Worsening Pulmonary Hypertension (ITT)|Any pulmonary arterial hypertension (PAH) events that occurred between randomization and Month 54 post-randomization were summarized. Development of PAH occurred if the participant met the following criteria, where the measurement value(s) could not be explained by other causes such as congestive heart failure or pulmonary emboli: 1) a post-baseline peak systolic pulmonary artery pressure > 55 mmHg by echocardiogram or 2) a mean pulmonary artery pressure > 30 mmHg at rest measured by right heart catheterization. If the post-baseline peak systolic pulmonary artery pressure was between 40 to 55 mmHg by echocardiogram, a right heart catheterization was done to confirm a diagnosis of pulmonary artery hypertension. The endpoint was met if the mean pulmonary artery pressure was > 30 mmHg at rest by right heart catheterization. Additionally, any adverse event reported as PAH was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291274|NCT00114530|Secondary|Initiating Use of Disease-Modifying Antirheumatic Drugs by Month 54 (DMARDs) (PP)|Initiation of disease-modifying antirheumatic drugs (DMARDs). Participants were not expected to receive additional disease-modifying therapy for systemic sclerosis (SSc) in the absence of disease progression. In general, this includes the administration of any therapy clearly given for the purpose of treating the underlying SSc. It does not include concomitant treatments permitted in the protocol, such as use of methotrexate (15 g or less), anti-malarials, or minocycline for arthritis only. Systemic corticosteroids given at > 10 mg/day (prednisone or prednisone equivalent), without clearly defined non-SSc indications, and methotrexate given for non-arthritis indications are examples of qualifying DMARDs.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291275|NCT00114530|Secondary|Initiating Use of Disease-Modifying Antirheumatic Drugs (DMARDs) by Month 54 (ITT)|Initiation of disease-modifying antirheumatic drugs (DMARDs). Participants were not expected to receive additional disease-modifying therapy for systemic sclerosis (SSc) in the absence of disease progression. In general, this includes the administration of any therapy clearly given for the purpose of treating the underlying SSc. It does not include concomitant treatments permitted in the protocol, such as use of methotrexate (15 g or less), anti-malarials, or minocycline for arthritis only. Systemic corticosteroids given at > 10 mg/day (prednisone or prednisone equivalent), without clearly defined non-SSc indications, and methotrexate given for non-arthritis indications are examples of qualifying DMARDs.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291276|NCT00114530|Secondary|Documented Myositis (PP)|Number of participants who experienced any event of myositis that occurred from randomization to Month 54 post-randomization. Documented myositis occurred if the participant had 1) elevated creatine phosphokinase (CPK), electromyography, and/or biopsy and 2) required > 30 mg per day prednisone for over 1 month or another therapy such as methotrexate (MTX) for treatment of myositis. Additionally, any adverse event reported as myositis was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291277|NCT00114530|Secondary|Documented Myositis (ITT)|Number of participants who experienced any event of myositis that occurred from randomization to Month 54 post-randomization. Documented myositis occurred if the participant had 1) elevated creatine phosphokinase (CPK), electromyography, and/or biopsy and 2) required > 30 mg per day prednisone for over 1 month or another therapy such as methotrexate (MTX) for treatment of myositis. Additionally, any adverse event reported as myositis was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291278|NCT00114530|Secondary|Occurrence of Scleroderma Renal Crisis (PP)|Documented scleroderma renal crisis (hypertensive or non-hypertensive) occurring from randomization to Month 54 post-randomization was summarized. A hypertensive scleroderma renal crisis occurred if a participant obtained both of the following: New-onset hypertension, defined as systolic blood pressure (SBP) >= 140 mmHg, diastolic blood pressure (DBP) >= 90 mmHg, a rise in SBP >= 30 mmHg compared to baseline, or a rise in DBP >= 20 mmHg compared to baseline, and one of the following features: 1) increase of >= 50 % above baseline in serum creatinine, 2) proteinuria (>= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5), 3) hematuria (>= 2+ by dipstick or > 10 RBCs/HPF, without menstruation), 4) thrombocytopenia (< 100,000 plts/mm3), or 5) hemolysis (determined by blood smear or increased reticulocyte count). Additionally, any adverse event reported as a scleroderma renal crisis was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291279|NCT00114530|Secondary|Occurrence of Scleroderma Renal Crisis (ITT)|Documented scleroderma renal crisis (hypertensive or non-hypertensive) occurring from randomization to Month 54 post-randomization was summarized. A hypertensive scleroderma renal crisis occurred if a participant obtained both of the following: New-onset hypertension, defined as systolic blood pressure (SBP) >= 140 mmHg, diastolic blood pressure (DBP) >= 90 mmHg, a rise in SBP >= 30 mmHg compared to baseline, or a rise in DBP >= 20 mmHg compared to baseline, and one of the following features: 1) increase of >= 50 % above baseline in serum creatinine, 2) proteinuria (>= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5), 3) hematuria (>= 2+ by dipstick or > 10 RBCs/HPF, without menstruation), 4) thrombocytopenia (< 100,000 plts/mm3), or 5) hemolysis (determined by blood smear or increased reticulocyte count). Additionally, any adverse event reported as a scleroderma renal crisis was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291280|NCT00114530|Secondary|New or Worsening Pulmonary Hypertension (PP)|Any pulmonary arterial hypertension (PAH) events that occurred between randomization and Month 54 post-randomization were summarized. Development of PAH occurred if the participant met the following criteria, where the measurement value(s) could not be explained by other causes such as congestive heart failure or pulmonary emboli: 1) a post-baseline peak systolic pulmonary artery pressure > 55 mmHg by echocardiogram or 2) a mean pulmonary artery pressure > 30 mmHg at rest measured by right heart catheterization. If the post-baseline peak systolic pulmonary artery pressure was between 40 to 55 mmHg by echocardiogram, a right heart catheterization would be done to confirm a diagnosis of pulmonary artery hypertension. The endpoint was met if the mean pulmonary artery pressure was > 30 mmHg at rest by right heart catheterization. Additionally, any adverse event reported as PAH was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291480|NCT00113399|Primary|Overall Survival||Date of death or last follow-up|This study terminated early with 15 subjects out of 240 subjects accrued, therefore no analyses were performed.||||||
1291282|NCT00114530|Secondary|New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (PP)|Any events that met the criteria outlined below or were reported as adverse events between randomization and Month 54 post-randomization are summarized. 1) Development of new or worsening arrhythmias that require medical treatment for >= 3 months or require ablative therapy or pacemaker insertion. (Note that for a participant who has medically controlled arrhythmia at randomization, worsening will be defined as breakthrough episodes severe enough to prompt change in medication, an increase in the dose of a medication or addition of a new medication to maintain control of the arrhythmia.) 2) Congestive heart failure (CHF) requiring clinical treatment for >= 3 months develops. 3) Clinically significant pericardial effusion (excess fluid around the heart) that required pericardial window.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291283|NCT00114530|Secondary|New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (ITT)|Any events that met the criteria outlined below or were reported as adverse events between randomization and Month 54 post-randomization are summarized. 1) Development of new or worsening arrhythmias that require medical treatment for >= 3 months or require ablative therapy or pacemaker insertion. (Note that for a participant who has medically controlled arrhythmia at randomization, worsening was defined as breakthrough episodes severe enough to prompt change in medication, an increase in the dose of a medication, or addition of a new medication to maintain control of the arrhythmia.) 2) Congestive heart failure (CHF) requiring clinical treatment for >= 3 months develops. 3) Clinically significant pericardial effusion (excess fluid around the heart) that required pericardial window.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291284|NCT00114530|Secondary|Change From Baseline to Month 54 in Modified Rodnan Skin Score (mRSS) (PP)|The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity. Analysis was based on an ordinal response variable, defined as follows: if the baseline mRSS was <=20, a decrease >=5 points from baseline indicated disease improvement and an increase >= 5 points indicated disease worsening; if the baseline mRSS was >20, then a decrease of >25% indicated disease improvement and an increase of >25% indicated disease worsening. Participants who do not meet the disease criteria outlined above were considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291285|NCT00114530|Secondary|Change From Baseline to Month 54 in Modified Rodnan Skin Score (mRSS) (ITT)|The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity. Analysis was based on an ordinal response variable, defined as follows: if the baseline mRSS was <=20, a decrease >=5 points from baseline indicated disease improvement and an increase >= 5 points indicated disease worsening; if the baseline mRSS was >20, then a decrease of >25% indicated disease improvement and an increase of >25% indicated disease worsening. Participants who do not meet the disease criteria outlined above were considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291286|NCT00114530|Secondary|Change From Baseline to Month 54 in Forced Vital Capacity (FVC) (PP)|Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled after a full breath and is a measure of lung function. Predicted FVC was based on institutional standards. Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >10% in FVC % Predicted indicated disease improvement, a decrease of >10% indicated disease worsening, and a change of <=10% was considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291287|NCT00114530|Secondary|Change From Baseline to Month 54 in Forced Vital Capacity (FVC) (ITT)|Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled after a full breath and is a measure of lung function. Predicted FVC was based on institutional standards. Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >10% in FVC % Predicted indicated disease improvement, a decrease of >10% indicated disease worsening, and a change of <=10% was considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291295|NCT00114530|Secondary|All-Cause Mortality (Month 48, ITT)|Any death, regardless of relationship to treatment, between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291481|NCT00113386|Primary|Comparison of Overall Survival||Date of death or date of last follow-up|This study terminated early with 19 out of 574 subjects accrued. Therefore no analysis was performed.||||||
1291288|NCT00114530|Secondary|Change From Baseline to Month 54 in Diffusion in Liters of Carbon Monoxide (DLCO) (PP)|Diffusion in liters of carbon monoxide (DLCO) is a measure of lung function. Predicted values for DLCO were computed using the Crapo Morris equations and adjusted per the Cotes formula for anemia, if a participant’s hemoglobin was <13 or >17 gm/dL, and altitude (Calgary site only). Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >15% in DLCO % Predicted indicated disease improvement, a decrease of >15% indicated disease worsening, and a change of <=15% was considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291289|NCT00114530|Secondary|Change From Baseline to Month 54 in Diffusion in Liters of Carbon Monoxide (DLCO) (ITT)|Diffusion in liters of carbon monoxide (DLCO) is a measure of lung function. Predicted values for DLCO were computed using the Crapo Morris equations and adjusted per the Cotes formula for anemia, if a participant’s hemoglobin was <13 or >17 gm/dL, and altitude (Calgary site only). Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >15% in DLCO % Predicted indicated disease improvement, a decrease of >15% indicated disease worsening, and a change of <=15% was considered “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291290|NCT00114530|Secondary|Change From Baseline to Month 54 in Short Form 36 Health Survey (SF-36) (PP)|The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. Each component was transformed into a 0-100 scale (higher numbers indicate greater quality of life) and normalized to have a mean of 50 and standard deviation of 10 for the 1998 general US population. Analysis was based on ordinal response, defined as follows for each component: a >= 10 point increase indicated disease improvement, a >= 10 point decrease indicated disease worsening, and a change <10 points indicated “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291291|NCT00114530|Secondary|Change From Baseline to Month 54 in Short Form 36 Health Survey (SF-36) (ITT)|The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. Each component was transformed into a 0-100 scale (higher numbers indicate greater quality of life) and normalized to have a mean of 50 and standard deviation of 10 for the 1998 general US population. Analysis was based on ordinal response, defined as follows for each component: a >= 10 point increase indicated disease improvement, a >= 10 point decrease indicated disease worsening, and a change <10 points indicated “no change”. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291292|NCT00114530|Secondary|Change From Baseline to Month 54 in Health Assessment Questionnaire - Disability Index (HAQ-DI) (PP)|HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities). The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. Analysis was based on an ordinal response variable, defined as follows: a decrease of >0.4 from baseline in the HAQ-DI score was considered disease improvement, an increase of >0.4 was considered disease worsening, and any change less than 0.4 was considered “no change.” Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291293|NCT00114530|Secondary|Change From Baseline to Month 54 in Health Assessment Questionnaire - Disability Index (HAQ-DI) (ITT)|HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities). The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. Analysis was based on an ordinal response variable, defined as follows: a decrease of >0.4 from baseline in the HAQ-DI score was considered disease improvement, an increase of >0.4 was considered disease worsening, and any change less than 0.4 was considered “no change.” Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291294|NCT00114530|Secondary|All-Cause Mortality (Month 48, PP)|Any death, regardless of relationship to treatment, between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm|||Participants|||Count of Participants
1291296|NCT00114530|Secondary|All-Cause Mortality (Month 54, PP)|Any death, regardless of relationship to treatment, between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm|||Participants|||Count of Participants
1291297|NCT00114530|Secondary|All-Cause Mortality (Month 54, ITT)|Any death, regardless of relationship to treatment, between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291298|NCT00114530|Secondary|Treatment-Related Mortality (Month 48, PP)|Death, occurring at any time between randomization and Month 48 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291299|NCT00114530|Secondary|Treatment-Related Mortality (Month 48, ITT)|Death, occurring at any time between randomization and Month 48 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291300|NCT00114530|Secondary|Treatment-Related Mortality (Month 54, PP)|Death, occurring at any time between randomization and Month 54 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291301|NCT00114530|Secondary|Treatment-Related Mortality (Month 54, ITT)|Death, occurring at any time between randomization and Month 54 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291302|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 48, PP)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291303|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 48, ITT)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291304|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 54, PP)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
1291305|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 54, ITT)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in diffusion in liters of carbon monoxide (DLCO) % predicted or >20% in forced vital capacity (FVC) % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
1291315|NCT00114244|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier by arm. The probability of progression-free survival at 3 months and overall survival at 6 months, and their Greenwood’s standard errors will be summarized by arm.|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 3 months||||Months||95% Confidence Interval|Median
1291306|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 48, PP)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Sum of subject-pair comparison scores||Full Range|Median
1291307|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 48, ITT)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Sum of subject-pair comparison scores||Full Range|Median
1291308|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 54, PP)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Sum of subject-pair comparison scores||Full Range|Median
1291309|NCT00114530|Primary|Global Rank Composite Score (GRCS) (Month 54, ITT)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Sum of subject-pair comparison scores||Full Range|Median
1291310|NCT00114517|Secondary|Number of Participants With Coronary Artery Calcium Measured by Cardiac Computed Tomography|measurement of coronary artery calcium at end of study|End of randomized treatment|CAC data was obtained in 380 participants. Participants who were not taking the study agents at the last follow-up visit, who had adherence to the study regimen that was lower than 80% or who had a CAC scan more than 6 months after the final study visit were not included in the analysis.|||Participants|||Count of Participants
1291311|NCT00114517|Secondary|Change in Neurocognitive Function (Global Cognition)|All neuropsychological test scores at baseline and follow-up assessments were standardized ([raw score – mean score]/standard deviation) using the baseline means and standard deviations from the entire ELITE sample. Each of three cognitive composite scores was calculated at baseline and follow-up assessments as the weighted average of the individual donor standardized test scores, weighted by the inverse correlation among tests.The change from baseline (endpoint minus baseline cognitive outcome) was computed for each of the cognitive scores (verbal memory, global cognition, and executive functions). Since the outcome is not a single test but a weighted average of multiple tests, the range is not standard and not reported. Higher scores mean better outcomes.|Baseline and at 2.5 years and 5 years|Early postmenopause group (<6 years since menopause) at baseline and late postmenopause group (>10 years since menopause) at baseline. Sample size represents the number of participants with analyzable data collected at baseline, 2.5 years and 5.0 years.|||units on a scale||95% Confidence Interval|Mean
1291312|NCT00114517|Primary|Rate of Change of Distal Common Carotid Artery (CCA) Far Wall Intima-media Thickness (IMT)||Twice at baseline and then every 6 months on trial|Early postmenopause group (<6 years since menopause) at baseline and late postmenopause group (>10 years since menopause) at baseline.|||mm per year||95% Confidence Interval|Mean
1291313|NCT00114504|Secondary|Circulating Inflammation Marker|Change in circulating hsCRP levels|Baseline, 3 months||||mg/dL||Standard Deviation|Mean
1291314|NCT00114504|Primary|Plaque Inflammation|Change in plaque inflammation was assessed by changes in the plaque SUV.|Baseline, 3 months||||SUV||Standard Deviation|Mean
1291317|NCT00114244|Primary|Objective Response (OR = CR or PR) as Determined by the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan, MRI, X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 6 weeks.||||participants|||Number
1291318|NCT00114231|Secondary|Local Recurrence Rate|The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.|Up to 5 years||||percentage of patients|||Number
1291319|NCT00114231|Secondary|Rate of Pathologic Complete Response of the Primary Tumor|The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.|Up to 5 years|Patients assessable for pathology results were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
1291320|NCT00114231|Secondary|Morbidity and Mortality Rate|Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.|Up to 30 days||||percentage of patients|||Number
1291321|NCT00114231|Secondary|R0 Resection Rate (Negative Margin Rate)|The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.|At time of surgery|Patients who had local excision are included in this analysis.|||percentage of patients|||Number
1291322|NCT00114231|Primary|3-Year Disease-free Survival|The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
1291323|NCT00114218|Primary|Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Count of participants with Toxicities maximum grade greater than or equal to grade 3|Assessed every 28 days (28 days=1 cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and Treated patients|||Participants|||Count of Participants
1291324|NCT00114218|Primary|Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and Treated patients|||Percentage of participants||95% Confidence Interval|Number
1291325|NCT00114166|Secondary|Reason Off Study Therapy||study entry through end of study treatment, up to 5 years|Eligible and evaluable participants|||Participants|||Count of Participants
1291326|NCT00114166|Primary|Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||Participants|||Count of Participants
1291327|NCT00114166|Primary|Objective Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal|Eligible and evaluable participants|||Participants|||Count of Participants
1291328|NCT00114140|Primary|Neurocognitive Function|Hopkins Verbal Learning Test (HVLT) is a test measuring learning memory retrieval, and memory consolidation processes.; Controlled Oral Word Association Test (COWAT) is a test of phonemic verbal fluency. The patient produces as many words as possible in 1 min. (each) for a specific letter (C, F, L or P, R, W).; Trail Making Test (TMT) is a measure of visuospatial scanning, attention, sequencing, and speed in Part A (TMT A) and executive function in Part B (TMT B). Patients must “connect the dots” either in a numbered sequence or alternating letters and numbers. Difference between pre-treatment baseline and follow-up assessment scores determined by the reliable change (RC) index, using a 90% confidence interval to designate statistically significant change.|Baseline, 6 months, and 12 months.|Eligible patients entered after QOL component amendment with baseline score and alive at 6 and 12 months for respective timepoint.|||participants|||Number
1291342|NCT00113880|Secondary|Rates of SAEs and Hospitalizations or Deaths Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated and TIV Controls|Incident rate comparisons of SAEs and hospitalizations or deaths with an identified decreased risk associated with FluMist recipients compared to TIV recipients; there were no significant decreases compared to the unvaccinated controls. There were no SAE and hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients compared to their controls.|180 days|Analyses were performed by period (180 days) and age group (5-8, 9-17, 18-49 years of age), post Dose 1. recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance was observed for any hospitalization or death, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
1291329|NCT00114140|Primary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR)|Functional Assessment of Cancer Therapy Scale with brain module (FACT-BR): a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions totalling 0-28), social/family well-being (7 questions totalling 0-28), emotional well-being (6 questions totalling 0-24), functional well-being (7 questions totalling 0-28) and brain cancer subscale which contains concerns relevant to patients with brain tumors (19 questions totalling 0-76). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 multiplied by the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total (0-184) is obtained by adding all domains together if the overall question response rate is greater than 80%.|Baseline, 6 months, and 12 months.|Eligible patients entered after QOL component amendment and alive at 6 and 12 months for respective post-baseline endpoints.|||units on a scale||Full Range|Median
1291330|NCT00114140|Primary|Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status|"Survival time is defined as time from registration to date of death from any cause. Progressive Disease (PD) is defined as 25% or > increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on clinical deterioration including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Survival and progression-free survival are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact."|Registration to 3 years|Eligible patients with O(6)-methylguanine-DNA methyltransferase (MGMT) status|||years||95% Confidence Interval|Median
1291331|NCT00114140|Primary|Progression-free Survival|Progressive Disease (PD) is defined as 25% or > increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on “clinical deterioration” including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Progression-free survival time is defined as time from registration to date of progressive disease or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Median survival time is reported.|From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years.|Eligible patients|||years||95% Confidence Interval|Median
1291332|NCT00114140|Primary|Overall Survival Rate at 3 Years|Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 3 years.|Registration to 3 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
1291333|NCT00114127|Secondary|CGI-S|"The Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).~Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6."|6 months||||Scores on a scale||Standard Error|Mean
1291334|NCT00114127|Primary|Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale|The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.|6 months||||Scores on a scale||Standard Error|Mean
1291335|NCT00114101|Post-Hoc|Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy|Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.|Duration of study (up to 10 years)||||participants|||Number
1291336|NCT00114101|Other Pre-specified|Overall Survival|Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||months||95% Confidence Interval|Median
1291337|NCT00114101|Secondary|Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100|"Response was defined according to International Myeloma Working Group criteria (2006)~Complete Response: Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Partial Response: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels~Marginal Response: 25-49% reduction in serum M-component & urine M-component by 50-89% which still exceeds 200mg/24hour~Progressive Disease: Defined in primary outcome measure~Stable Disease: Not meeting any of the criteria above"|Day 100||||participants|||Number
1291338|NCT00114101|Primary|Time to Progression|"Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.~Progression was defined per the International Myeloma Working Group definition as one more of the following:~25% increase in serum M-component (absolute increase >= 0.5g/dl)~25% increase in urine M-component (absolute increase >= 200mg/24hour~25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~25 % increase in bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas~Development of hypercalcemia"|Duration of study (up to 10years)||||months||95% Confidence Interval|Median
1291339|NCT00113919|Primary|Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients|maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are > or = 65 years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine clearance < 30 ml/min|three years|||||||
1291343|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls|Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to TIV recipients. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to TIV recipients.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
1291344|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls|Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to Unvaccinated Controls. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to Unvaccinated Controls.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
1291345|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls Within 42 Days|Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in TIV recipients within 42 days. There was no significant decreased risk in comparison to unvaccinated controls within the 42-day timeframe.|42 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
1291346|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Increased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls|Incident rate comparisons of MAEs with an identified increased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in unvaccinated recipients. There was no increased risk at 3 or 21 days and there was no increased risk compared to the Within Cohort or TIV control groups.|42 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
1291347|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Within Cohort Controls|Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in within cohort controls within 21 days. There was no significant decreased risk in comparison to unvaccinated or TIV controls within the 21-day timeframe.|21 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
1291348|NCT00113880|Primary|Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls|Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to TIV controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.|180 days|Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospital/death setting 180 days post Dose 1, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
1291349|NCT00113880|Primary|Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls|Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to unvaccinated controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.|180 days|Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospitalization/death setting, 180 days post Dose 1, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
1291350|NCT00113880|Primary|Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls|Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to TIV controls. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
1291351|NCT00113880|Primary|Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group|Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
1291352|NCT00113880|Primary|Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significantly decreased risk compared to the within cohort and unvaccinated controls. No MAEs potentially related to wild-type influenza were associated with a significantly increased risk in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). significance was observed for encephalitis/encephalopathy, for all age groups, across all settings within 42 days, PD1.|||Cases per 1,000 person-months|Participants||Number
1291353|NCT00113880|Primary|Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/RAD, wheezing/shortness of breath (SOB), and any ashtma or wheezing event across all settings, PD1 (all age groups) and PD2.|||Cases per 1,000 person-months|Participants||Number
1291354|NCT00113880|Primary|Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the unvaccinated control group for all ages, 5-8, and 9-17 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the unvaccinated control group.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/reactive airway disease (RAD) and any ashtma or wheezing event across all settings, PD1 (all ages and 9-17 yrs) and PD2 (5-8 yrs).|||Cases per 1,000 person-months|Participants||Number
1291355|NCT00113880|Primary|Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days and 42 days (all age groups) and post Dose 2 (PD2) within 42 days (5-8 yrs).|||Cases per 1,000 person-months|Participants||Number
1291356|NCT00113880|Primary|Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the within cohort control observed for all ages and 5-8 years of age within 21 days and compared to the unvaccinated control obseved for 18-49 years of age within 42 days. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the within cohort or unvaccinated control groups.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days for within cohort and within 42 days for unvaccinated.|||Cases per 1,000 person-months|Participants||Number
1291357|NCT00113880|Primary|Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.|There were no acute respiratory tract events, acute gastrointestinal tract events, or systemic bacterial infections with an identified increased or decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).|||Cases per 1,000 person-months|Participants||Number
1291358|NCT00113880|Primary|Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|Incident rate comparisons associated with a significantly increased risk in FluMist recipients compared to the within cohort control group for urticaria; there was no increased risk compared to the unvaccinated and TIV control groups and there were no anaphylaxis events that occurred within the 3-day risk period post vaccination.|3 days|Analyses were performed by period (3 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).|||Cases per 1,000 person-months|Participants||Number
1291359|NCT00113880|Primary|Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|Incident rate comparisons of MAEs with an identified decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone. All terms were analyzed for the entire population regardless of gender.|21 and 42 days|Analyses performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (1 or 2 for ages 5-8 years). Significance observed in the clinic, 21 days post Dose 1 in 1 subj. (heart murmur, all ages combined); 18 and 19 subj.(pregnancy exam, 18-49 and all ages combined).|||Cases per 1,000 person-months|Participants||Number
1291380|NCT00113568|Primary|Number of Subjects With Adverse Events That Led to Discontinuation From the Study|The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator|Up to 27 menstrual cycles||||participants|||Number
1291381|NCT00113568|Primary|Number of Subjects With at Least One Life-Threatening Adverse Event During the Study|A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
1291482|NCT00113373|Secondary|Prognostic Variable: Cellular Histology|Number of patients with Clear Cell Carcinoma or Mucinous Carcinoma|Baseline|Eligible and evaluable patients|||Participants|||Count of Participants
1291360|NCT00113880|Primary|Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the clinic setting, 21 days post Dose 1 in 7 subjects (breast lump/cyst, 9-17 yrs) and in 22 subjects (mastitis, 18-49 yrs).|||Cases per 1,000 person-months|Participants||Number
1291361|NCT00113841|Primary|Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment|Percent change of NF-kB =[(expression at 4 weeks- expression at baseline)/expression at baseline]*100%. Bone marrow aspirate/biopsy for expression of NF-kB and related genes/proteins markers at baseline and after 4 weeks.|Baseline through 4 weeks of treatment|All participants in the two arms (Curcumin versus Curcumin plus Bioperine) who received at least 4 weeks of treatment were eligible for outcome evaluation.|||Percent reduction||Standard Deviation|Mean
1291362|NCT00113763|Post-Hoc|Progression-free Survival Time (Mutant KRAS)|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with mutant KRAS was 24.4 weeks in the panitumumab plus BSC group and 23.9 weeks in the BSC alone group.|Mutant KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||weeks||95% Confidence Interval|Median
1291363|NCT00113763|Post-Hoc|Progression-free Survival Time (Wild-type KRAS)|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with wild-type KRAS was 36.8 weeks in the panitumumab plus BSC group and 35.7 weeks in the BSC alone group.|Wild-type KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||weeks||95% Confidence Interval|Median
1291364|NCT00113763|Secondary|Duration of Stable Disease|Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Participants who had a best overall response of stable disease|||weeks||95% Confidence Interval|Median
1291365|NCT00113763|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT)|||weeks||95% Confidence Interval|Median
1291366|NCT00113763|Secondary|Time to Disease Progression|Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat|||weeks||95% Confidence Interval|Median
1291367|NCT00113763|Secondary|Time to Response|Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT) participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.|||weeks||Inter-Quartile Range|Median
1291368|NCT00113763|Secondary|Duration of Response|Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.|||weeks||95% Confidence Interval|Median
1291382|NCT00113568|Primary|Number of Subjects With at Least One Serious Adverse Event During the Study|A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
1291369|NCT00113763|Secondary|Objective Tumor Response|Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT)|||participants|||Number
1291370|NCT00113763|Secondary|Overall Survival|Kaplan-Meier estimates of median time from randomization to death.|From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group.|Intention-to-treat (ITT)|||months||95% Confidence Interval|Median
1291371|NCT00113763|Primary|Progression-free Survival Time|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.|Intention-to-treat (ITT)|||weeks||95% Confidence Interval|Median
1291372|NCT00113607|Secondary|Median Maximum Plasma Concentration (Cmax) of Trabectedin.|Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.|Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2|Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.|||pg/mL|||Number
1291373|NCT00113607|Secondary|Median Area Under Curve (AUC) of Trabectedin.|Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.|Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2|Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.|||ng*h/mL|||Number
1291374|NCT00113607|Secondary|Duration of Response: Independent Radiologist Review|Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease.|From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years|All Responders (CR/PR) Analysis Participants: all participants who achieved CR or PR as best overall response during the study.|||Months||95% Confidence Interval|Median
1291375|NCT00113607|Secondary|Objective Response Rate (ORR) - Independent Radiologist Review|Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years|All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not.|||Percentage of participants|||Number
1291376|NCT00113607|Secondary|Overall Survival|Overall survival was defined as the time between the randomization and death|From the date of randomization until the date of death, as assessed for approximately 3 years|All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not|||Months||95% Confidence Interval|Median
1291377|NCT00113607|Primary|Progression-Free Survival (PFS): Independent Radiologist Review|PFS is defined as the time between randomization and disease progression or death.|From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years|All Measurable Analysis Participants: All randomized participants who had measurable disease at baseline as assessed by the independent radiology review. Measurable disease is defined as having at least 1 lesion measured with a diameter of ≥20 mm using conventional techniques or of ≥10 mm using a spiral computerized tomography scan.|||Months||95% Confidence Interval|Median
1291378|NCT00113568|Primary|Number of Subjects Who Died During the Study|Number of subjects who died, for any reason, during the study|Up to 27 menstrual cycles||||participants|||Number
1291379|NCT00113568|Primary|Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study|Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
1291383|NCT00113568|Primary|Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
1291384|NCT00113568|Primary|Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
1291385|NCT00113568|Primary|Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
1291386|NCT00113568|Primary|Number of Subjects With at Least One Adverse Event During the Study|An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
1291387|NCT00113555|Secondary|Provocative Pad Weight|Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.|Baseline to 12 months|Intent to Treat|||gm||Standard Deviation|Mean
1291388|NCT00113555|Secondary|Number of Pads Changed Per Day (Voiding Diary)|Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.|Baseline to 12 months|Intent to Treat|||Number of Pads Changed per Day||Standard Deviation|Mean
1291389|NCT00113555|Secondary|Number of Incontinence Episodes Per Day (Voiding Diary)|Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.|Baseline to 12 months|Intent to Treat|||units on a scale||Standard Deviation|Mean
1291390|NCT00113555|Secondary|Urinary Distress Inventory (UDI-6)|Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.|Baseline to 12 months|Intent to Treat|||units on a scale||Standard Deviation|Mean
1291391|NCT00113555|Secondary|Incontinence Impact Questionnaire (IIQ-7)|Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence.|Baseline to 12 months|Intent to Treat|||units on a scale||Standard Deviation|Mean
1291392|NCT00113555|Secondary|Incontinence Quality of Life (IQoL) Questionnaire|Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life.|Baseline to 12 months|Intent to Treat|||units on a scale||Standard Deviation|Mean
1291393|NCT00113555|Primary|Change of Stamey Grade From Baseline to 12 Months.|"The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed.~The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1."|Baseline to 12 months|Intent to Treat|||units on a scale||95% Confidence Interval|Mean
1291394|NCT00113529|Secondary|Ctrough of Gefitinib||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.|||ng/mL||Standard Deviation|Mean
1291395|NCT00113529|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.|||ng/mL||Standard Deviation|Mean
1291396|NCT00113529|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|Pharmacokinetic (PK) = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.|||ng/mL||Standard Deviation|Mean
1291397|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291398|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291495|NCT00113295|Secondary|Response, Clinical Global Impression of Improvement (CGI-I)|Response was measured as a secondary outcome using the Clinical Global Impression of Improvement (CGI-I). Response was defined as a score of 1 [“very much improved”] or 2 [“much improved”] at study endpoint.|Week 18 (Phase 2 Endpoint)||||participants|||Number
1291399|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291400|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291401|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291402|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291403|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291404|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291405|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291406|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291407|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291408|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
1291409|NCT00113529|Secondary|sVEGFR3 Ratio to Baseline at Each Time Point|sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
1291410|NCT00113529|Secondary|Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline|Concentration of sVEGFR3 at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.|||pg/mL||Standard Deviation|Mean
1291411|NCT00113529|Secondary|sVEGFR2 Ratio to Baseline at Each Time Point|sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
1291412|NCT00113529|Secondary|Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline|Concentration of sVEGFR2 at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.|||pg/mL||Standard Deviation|Mean
1291413|NCT00113529|Secondary|VEGF-C Ratio to Baseline at Each Time Point|VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
1291414|NCT00113529|Secondary|VEGF-C Concentration at Baseline|Concentration of VEGF-C at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.|||pg/mL||Standard Deviation|Mean
1291415|NCT00113529|Secondary|VEGF Ratio to Baseline at Each Time Point|VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
1291416|NCT00113529|Secondary|VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline|Concentration of VEGF at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.|||pg/mL||Standard Deviation|Mean
1291417|NCT00113529|Secondary|Probability of Survival at One Year|Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year|ITT|||probability|||Number
1291418|NCT00113529|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death|ITT. Number of participants analyzed = those who progressed or died due to any cause while on study.|||weeks||95% Confidence Interval|Median
1291419|NCT00113529|Secondary|Overall Survival (OS)|OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used.|From start of study treatment until death|ITT. Number of participants analyzed = subjects who died.|||weeks||Full Range|Median
1291420|NCT00113529|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|ITT. Number of participants analyzed = those who progressed on study.|||weeks||95% Confidence Interval|Median
1291421|NCT00113529|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR).|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer|ITT. Number of participants analyzed = those who had a response and subsequent progression or death due to any cause while on study.|||weeks||Full Range|Median
1291422|NCT00113529|Secondary|Time to Tumor Response (TTR)|TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|ITT. Number of participants analyzed = those who had a confirmed response on study.|||weeks||95% Confidence Interval|Median
1291452|NCT00113516|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
1291423|NCT00113529|Primary|Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|Intent-to-treat (ITT) = all subjects enrolled in the study that received at least 1 dose of study medication (sunitinib or gefitinib).|||participants|||Number
1291424|NCT00113516|Secondary|Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)|QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.|Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2|ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.|||scores on a scale||Standard Error|Mean
1291425|NCT00113516|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.|Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2|ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.|||scores on a scale||Standard Error|Mean
1291426|NCT00113516|Secondary|Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib|A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized.|Within 7 days of Day 1|c-Kit, Flt-3 and c-Fms to safety of Sunitinib samples were collected and analyzed. However, there was no statistics performed since power was insufficient.|||pg/mL|||Number
1291427|NCT00113516|Secondary|Immunohistochemical Staining of Paraffin Embedded Tumor Tissue|Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.|Screening|Samples were collected and stained from a subset of subjects. Due to the small sample size, no correlative analyses with clinical outcome were conducted.|||samples|||Number
1291428|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline|OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), Cycle 4, Day 28 (< median cutpoint, > = median cutpoint)and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated.|||months||95% Confidence Interval|Median
1291429|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.|||months||95% Confidence Interval|Median
1291430|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline|OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from Baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), median and/or CI were not able to be estimated.|||months||95% Confidence Interval|Median
1291453|NCT00113516|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
1291431|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
1291432|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint), and Cycle 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
1291433|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
1291434|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|[Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
1291435|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
1291436|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after Stratification by < or > = median changes from Baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
1291437|NCT00113516|Secondary|Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 4, Day 28 and Cycle 5, Day 28.|||ratio|||Number
1291438|NCT00113516|Secondary|Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL|||Number
1291439|NCT00113516|Secondary|VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.|||ratio|||Number
1291440|NCT00113516|Secondary|VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL|||Number
1291441|NCT00113516|Secondary|VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.|||ratio|||Number
1291442|NCT00113516|Secondary|VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL|||Number
1291443|NCT00113516|Secondary|Soluble E-Selectin Ratio to Baseline at Each Time Point|Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. At Cycle 4, Day 28, median and/or standard deviation were not able to be estimated.|||ratio||Standard Deviation|Mean
1291444|NCT00113516|Secondary|Soluble E-Selectin at Baseline|Concentration of soluble E-Selectin at baseline.|Baseline (Cycle 1, Day 1) of Part 2|MITT. Number of participants analyzed = number of subjects with soluble E-Selectin data at Baseline.|||nanograms (ng)/mL||Standard Deviation|Mean
1291445|NCT00113516|Secondary|VEGF-C Ratio to Baseline at Each Time Point|VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
1291446|NCT00113516|Secondary|VEGF-C Concentration at Baseline|Concentration of VEGF-C at baseline.|Baseline (Cycle 1, Day 1) of Part 2|MITT. Number of participants analyzed = number of subjects with VEGF-C data at Baseline.|||pg/mL||Standard Deviation|Mean
1291447|NCT00113516|Secondary|VEGFR3 Ratio to Baseline at Each Time Point|VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
1291448|NCT00113516|Secondary|Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline|Concentration of VEGFR3 at baseline.|Baseline (Cycle 1, Day 1) of Part 2|Modified ITT population (MITT) = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin and at least 1 dose of Sunitinib.|||picograms (pg)/milliliter (mL)||Standard Deviation|Mean
1291449|NCT00113516|Secondary|Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
1291450|NCT00113516|Secondary|Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
1291451|NCT00113516|Secondary|Dose-Corrected Ctrough of Sunitinib|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
1291469|NCT00113425|Secondary|Change From Baseline in Closed Comedones at Week 16||Baseline and Week 16||||closed comedones||95% Confidence Interval|Mean
1291454|NCT00113516|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|Pharmacokinetic (PK) = all subjects enrolled in the study who received at least 1 dose of carboplatin/paclitaxel or sunitinib. Subjects with plasma values below limit of quantification were excluded.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
1291455|NCT00113516|Secondary|Overall Survival (OS)|OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death − date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment.|From start of study treatment until death|ITT|||months||95% Confidence Interval|Median
1291456|NCT00113516|Secondary|Number of Subjects With Overall Confirmed Objective Disease Response|Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)|ITT|||participants|||Number
1291457|NCT00113516|Secondary|Duration of Response (DR)|DR=time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a > = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR – first CR or PR that was subsequently confirmed +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death|ITT. DR was calculated for the subgroup of subjects with objective response. 23 subjects reported CR or PR response and were analyzed for DR.|||weeks||95% Confidence Interval|Median
1291458|NCT00113516|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date – first paclitaxel/carboplatin dose date +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)|ITT|||weeks||95% Confidence Interval|Median
1291459|NCT00113516|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death|ITT|||weeks||95% Confidence Interval|Median
1291460|NCT00113516|Primary|Proportion of Subjects Surviving at One Year|Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.|From start of treatment until 1 year or death|Intent-to-treat (ITT) population = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin.|||proportion|||Number
1291461|NCT00113490|Secondary|Motavizumab Serum Concentrations at Each Data Collection Visit|Mean serum concentration.|Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose|All subjects who received any study drug were included in all summaries. Day 0 n= 66; Day 25-30 n=65; Day 120 n=63; 30 days post final dose n=63; 90-120 days post final dose n=62|||ug/mL||Standard Deviation|Mean
1291462|NCT00113490|Secondary|Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations|Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.|||participants|||Number
1291463|NCT00113490|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Assessments of SAEs were made by clinical investigators according to the protocol.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.|||participants|||Number
1291464|NCT00113490|Secondary|Number of Subjects Reporting Adverse Events (AEs)|Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.|||participants|||Number
1291465|NCT00113490|Primary|Number of Subjects Exhibiting Anti-motavizumab Antibodies|Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.|Day 0 through 120 days post final dose|All subjects who received any study drug were included in all summaries of immunogenicity. Day 0 n=66 mota, n=70 pali; Day 25-30 n=65 mota, n=69 pali; Day 120 n=64 mota, n=67 pali; 30 days post final dose n=65 mota, n=67 pali; 90-120 days post final dose n=64 mota, n=67 pali; at any time n=66 mota, n=70 pali.|||participants|||Number
1291466|NCT00113425|Secondary|Change From Baseline in Acne Severity at Week 16|The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.|Baseline and Week 16||||units on a scale||95% Confidence Interval|Mean
1291467|NCT00113425|Secondary|Change From Baseline in Erythematous Macules at Week 16||Baseline and Week 16||||erythematous macules||95% Confidence Interval|Mean
1291468|NCT00113425|Secondary|Change From Baseline in Open Comedones at Week 16||Baseline and Week 16||||open comedones||95% Confidence Interval|Mean
1291483|NCT00113373|Secondary|Prognostic Variables: Performance Status|Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
1291484|NCT00113373|Secondary|Prognostic Variable: Platinum Sensitivity|Patients who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant. Patients who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive. Patients who had disease progression beyond12 months of ending their last platinum regimen were also considered platinum sensitive.|Baseline|Eligible and evaluable patients|||Participants|||Count of Participants
1291485|NCT00113373|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, assessed up to 5 years|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1291486|NCT00113373|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for 6 months and then every 6 months for up to 5 years.|Eligible and evaluable patients|||months||95% Confidence Interval|Median
1291487|NCT00113373|Secondary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Baseline, every other cycle for 6 months and then every 6 months for up to 5 years|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1291488|NCT00113373|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and evaluable|||Participants|||Count of Participants
1291489|NCT00113373|Primary|Progression-free Survival (PFS) > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1291490|NCT00113360|Primary|Progression Free Survival (PFS)|PFS is measured from date of trial entry until documented progression of disease or death from any cause. PFS is measured by computed tomography (CT) scans or magnetic resonance imaging (MRI) performed at baseline and after every three cycles.|PFS assessed every 12 weeks (at the end of every 3 cycles) or more frequently if clinically indicated|Per protocol|||Weeks||95% Confidence Interval|Median
1291491|NCT00113334|Primary|Response Rate|Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon’s optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.|Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.|Three (3) patients were inevaluable for response.|||participants|||Number
1291492|NCT00113321|Primary|Overall Response|Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.|Blood tests baseline and after completing 8-12 weeks of therapy|Treated population (16 patients); No further analysis done since study terminated early due to low accrual.|||Participants|||Number
1291493|NCT00113295|Secondary|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).|The 16-item Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is used to assess quality of life changes with treatment. Total scores range from 14-70, with higher levels of satisfaction yielding higher scores.|Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)||||units on a scale||Standard Deviation|Mean
1291494|NCT00113295|Secondary|Depressive Symptoms, Montgomery–Asberg Depression Rating Scale (MADRS)|Depressive symptoms were measured at a secondary outcome using the Montgomery–Asberg Depression Rating Scale (MADRS). Each item is scored on a scale of 1-6; The total score range is 0-60, with higher scores indicated higher levels of depression severity.|Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)||||units on a scale||Standard Deviation|Mean
1297091|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 8||Baseline to Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1291496|NCT00113295|Primary|Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.|"Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint.~The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD."|Baseline and Week 18|Twenty-two patients were randomized, 11 to quetiapine and 11 to placebo augmentation, and all had at least one assessment postrandomization and were included in the phase 2 efficacy analyses; of this group, six randomized to quetiapine (54.5%) and ten to placebo (90.1%) completed the trial.|||units on a scale||Standard Deviation|Mean
1291497|NCT00113295|Secondary|Remission (HAM-A ≤ 7)|Remission was measured as a secondary outcome using a score of less than or equal to 7 on the Hamilton Anxiety Scale (HAM-A).|Week 18 (Study Endpoint)||||participants|||Number
1291498|NCT00113269|Secondary|Renal Function Abnormalities Based on Serum Creatinine|"Decrease in serum creatinine usually indicates an improvement.~Change in creatinine clearance from month 1 was calculated.~Change from 1 month is calculated by month 36 – month 1."|1 month and End of Study (36 months)|The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as “N”.|||mcmol/L||Standard Deviation|Mean
1291499|NCT00113269|Secondary|Renal Function Abnormalities Based on Creatinine Clearance|"Increases in creatinine clearance usually indicates an improvement.~Change in creatinine clearance from month 1 was calculated.~Change from 1 month is calculated by month 36 – month 1."|1 month and End of Study (36 months)|The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as “N”.|||mL/s||Standard Deviation|Mean
1291500|NCT00113269|Secondary|Overall Patient Survival|"Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
1291501|NCT00113269|Secondary|Patient Survival at 12 Months|"Patient survival is defined as not dead within 12 months after skin closure.~Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first."|12 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
1291502|NCT00113269|Secondary|Overall Graft Survival|"Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
1291503|NCT00113269|Secondary|Graft Survival at 12 Months|"Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.~Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first."|12 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
1291504|NCT00113269|Secondary|Time to First BCAR|"Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|"The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.~Only patients who experienced BCAR were included in the analysis."|||Days||Full Range|Median
1291505|NCT00113269|Secondary|Clinically Treated Acute Rejection|"Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
1291506|NCT00113269|Secondary|Efficacy Failure|"Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
1291507|NCT00113269|Secondary|Overall Patient Incidence of BCAR|"Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3).~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
1291508|NCT00113269|Primary|Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months|"A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3).~Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st."|6 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients||95% Confidence Interval|Number
1291509|NCT00113230|Primary|Pathologic Local Tumor Response|At follow-up evaluation after completion of neoadjuvant and surgical therapy, resected primary tumor classified based on routine pathology staining in the following manner: Pathologic Complete Response (no evidence of residual cancer); Microscopic Residual (no grossly detected disease, but evidence of microscopic residual disease); and Gross Residual Disease.|Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor)|Intention to treat analysis method. Data examination conducted upon enrollment and evaluability of 25 patients.|||Participants|||Number
1291510|NCT00113217|Secondary|Safety of Treatment|Safety measured by participant toxicities in therapy with bevacizumab for Renal Cell Carcinoma (RCC).|Following 56 days treatment|||||||
1291511|NCT00113217|Primary|Progression Free Survival (PFS)|Time to progression calculated from the start of the study drug to the first evidence of disease progression. Time to progression reported as PFS measured in months. Progression (or progressive disease) defined by Response Evaluation Criteria in Solid Tumors (RECIST) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 3 years (or until disease progression)||||months||95% Confidence Interval|Median
1291512|NCT00113087|Secondary|Number of Participants With Moderate to Severe AV Valve Regurgitation|Number of participants with moderate to severe AV valve regurgitation.|at age 14 months|ITT, no imputation|||participants|||Number
1291513|NCT00113087|Secondary|Number of Participants With Moderate to Severe AV Valve Regurgitation|Number of participants with Moderate to severe AV valve regurgitation.|just before the pre-Glenn surgery|ITT, no imputation|||participants|||Number
1291514|NCT00113087|Secondary|Ventricular Filling Pressure|Ventricular filling pressure measured by catherization|just before the Glenn surgery|ITT, no imputation|||mmHg||Standard Deviation|Mean
1291515|NCT00113087|Secondary|Ventricular Mass to Volume Ratio|Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.|Measured at 14 months of age|Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months)|||g/ml||Standard Deviation|Mean
1291516|NCT00113087|Secondary|Ventricular Mass to Volume Ratio|Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.|Measured just before the Glenn surgery|Intention-to-treat analysis of participants completing the pre-Glenn visit|||g/ml||Standard Deviation|Mean
1291517|NCT00113087|Secondary|End-diastolic Volume Z-score|Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
1291518|NCT00113087|Secondary|End Diastolic Volume Z-score|Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation|||standard deviation||Standard Deviation|Mean
1291519|NCT00113087|Secondary|End-diastolic Volume|Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.|at 14 months of age|ITT, no imputation|||ml||Standard Deviation|Mean
1291520|NCT00113087|Secondary|End-diastolic Volume|Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation|||ml||Standard Deviation|Mean
1291521|NCT00113087|Secondary|Ventricular Mass Z-score|Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
1291522|NCT00113087|Secondary|Ventricular Mass Z-score|Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation|||standard deviation||Standard Deviation|Mean
1291523|NCT00113087|Secondary|Ventricular Mass|Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40|At 14 months of age|ITT, no imputation|||g||Standard Deviation|Mean
1291524|NCT00113087|Secondary|Ventricular Mass|Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation|||g||Standard Deviation|Mean
1291525|NCT00113087|Secondary|Ejection Fraction (%)|Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction (%) is defined as percentage of stroke volume of a ventricle (i.e. the difference between end diastolic and end systolic volumes)relative to end diastolic volume.|at 14 months of age|ITT, no imputation|||percent (of end diastolic volume)||Standard Deviation|Mean
1292332|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1825 days||||percentage of participants|||Number
1291526|NCT00113087|Secondary|Ejection Fraction (%)|Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction % is defined as the percentage of the stroke volume (i.e. difference between end-diastolic and end-systolic volumes) in a ventricle relative to end-diastolic volume.|just before the Glenn surgery|ITT, no imputation|||percent (of end diastolic volume)||Standard Deviation|Mean
1291527|NCT00113087|Secondary|MacArthur-Bates Inventory -Words Produced|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score.|at 14 months of age|ITT, no imputation|||standard deviation||Inter-Quartile Range|Median
1291528|NCT00113087|Secondary|MacArthur-Bates Inventory -Total Gestures|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
1291529|NCT00113087|Secondary|MacArthur-Bates Inventory -Words Understood|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
1291530|NCT00113087|Secondary|MacArthur-Bates Inventory -Phrases Understood|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
1291531|NCT00113087|Secondary|Neurodevelopmental Status (FSII)|Functional status II (Revised) Total Score. Scale ranges up to 100.00, the higher the better. The score presents an instrument for assessing health status for children surviving long term with chronic physcial disorders.|at 14 months of age|ITT, no imputation|||units on a scale||Inter-Quartile Range|Median
1291532|NCT00113087|Secondary|Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score|Neurodevelopmental status(MDI):Bayley Scales of infant development, Mental Developmental Index z-score .|at 14 months of age|ITT, not imputation|||standard deviation||Standard Deviation|Mean
1291533|NCT00113087|Secondary|Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score|"Neurodevelopmental status (PDI):~the Bayley Scales of Infant Development: Psychomotor Development index z-score ."|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
1291534|NCT00113087|Secondary|B-type Natriuretic Peptide Level|B-type natriuretic peptide (BNP) level.|at the time of the 14 month visit|ITT, no imputation|||pg/ml||Inter-Quartile Range|Median
1291535|NCT00113087|Secondary|B-Type Natriuretic Peptide|B-Type Natriuretic Peptide (BNP) level.|Measured just prior to the Glenn surgery|ITT analysis, no imputation|||pg/ml||Inter-Quartile Range|Median
1291536|NCT00113087|Secondary|Number of Participants With Ross Heart Failure Class I|Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.|Measured at 14 months of age|Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months)|||participants|||Number
1291537|NCT00113087|Secondary|Number of Participants With Ross Heart Failure Class I|Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.|Just prior to the pre-Glenn surgery|Intention-to-treat analysis of participants measured just prior to the Glenn surgery|||Participants|||Number
1291538|NCT00113087|Secondary|Head Circumference-for-age Z-score|Head circumference-for-age z-score at 14 months of age.In primary analysis outcome is defined as predicted mean of Head circumference z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|ITT, no imputation|||standard deviation||Standard Error|Least Squares Mean
1291539|NCT00113087|Secondary|Height-for-age Z-score|Height-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of height z-score at age 14 months based on longitudinal modeling (adjusted bor baseline value)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age||||standard deviation||Standard Error|Least Squares Mean
1291540|NCT00113087|Primary|Weight-for-age Z-score at 14 Months of Age|Weight-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of weight z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|ITT, no imputation|||standard deviation||Standard Error|Least Squares Mean
1291541|NCT00113022|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a measure of depression severity examined on a weekly basis. The minimum score on the 10 item scale is 0 indicating no depression. The maximum score is 60 indicating a very severe depression. Scores of 18 and above are generally considered to suggest significant levels of depression.|8 weeks||||Scores on a scale||Standard Error|Least Squares Mean
1291542|NCT00112957|Secondary|Number of Patients With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period.|Continuously for up to 20 months|The Safety Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1.|||Participants|||Count of Participants
1291543|NCT00112957|Secondary|Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination|NY-ESO-1 antigen-specific delayed-type hypersensitivity (DTH) was measured by skin test at Screening and on Days 113 and 197. All patients were tested for the NY-ESO-1 protein, with additional DTH testing as follows: patients who were HLA-A2+ had NY-ESO-1b testing, patients who were HLA-DP4+ had NY-ESO-DP4 testing, and patients who were both HLA-A2+ and HLA-DP4+ had NY-ESO-1b and NY-ESO-DP4 testing.|Up to 6 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
1291544|NCT00112957|Secondary|Number of Patients With Detectable T-cell Responses Following Vaccination|NY-ESO-1-specific CD8+ T cells (human leukocyte antigen [HLA]-A2 patients only) and NY-ESO-1-specific CD4+ T cells (HLA-DP4 patients only) were measured by interferon-gamma enzyme-linked immunosorbent spot (ELISPOT) assay. The response to the ELISPOT assay was considered to be positive if the number of spots in the peptide-exposed well was 2-fold or more higher than the number of spots in the unstimulated well, and if there was a minimum of 10 (after subtraction of background spots) peptide-specific spots/25,000 T-cells, or less if T-cell clones were used.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
1291545|NCT00112957|Secondary|Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens|Intracellular cytokine staining assays were performed at Screening, Days 85 and 197, Month 6, and Month 12 to evaluate the release of interferon-gamma by CD4 and CD8 T cells following study injections.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
1291546|NCT00112957|Secondary|Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity|Specific antibody response to the NY-ESO-1 and LAGE-1 antigen was measured by enzyme-linked immunosorbent assay (ELISA) at Screening, Days 29, 57, 85, 113, 141, 169, 197, Month 6, and Month 12.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
1291547|NCT00112957|Secondary|Mean Absolute Cancer Antigen-125 Values Over Time on Study|Blood samples were collected to measure serum levels of tumor marker cancer antigen (CA)-125 at Screening and on Days 1, 29, 57, 85, 113, 141, 169, and 197 and every 2 months for at least 12 months following Day 197.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||U/mL||Standard Deviation|Mean
1291548|NCT00112957|Secondary|Number of Patients With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and were categorized according to RECIST (version 1.0) at Screening, on Days 85 and 197 and every 2 months thereafter for at least 12 months. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions (no evaluable disease); Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
1291549|NCT00112957|Secondary|Mean Time to Failure Among Patients Who Progressed On Study|TTF was calculated as the number of days from the first dose until the patient discontinued due to progressive disease. Patients who completed the study or discontinued for other reasons were considered censored at the day of their last study visit, including the follow-up visits after Day 197. Progression was defined using the Response Evaluation Criteria In Solid Tumors (RECIST [version 1.0]) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. TTF was calculated for the subset of patients who had disease progression at any time.|||days||Standard Deviation|Mean
1291550|NCT00112957|Primary|Percentage of Patients in Remission at 1 Year|Time to failure (TTF) was evaluated as the crude proportion of patients in remission at 1 year, calculated as: 100 x (number of patients in remission at 1 year)/(number of patients with known status at 1 year). The Kaplan-Meier cumulative estimate of the proportion of patients in remission at 1 year was also calculated.|12 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||percentage of participants||95% Confidence Interval|Number
1291551|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis|An overall survival event was death due to any cause.|From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).|ITT patients with Stage III disease.|||participants|||Number
1291552|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis|Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.|From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).|ITT patients with Stage III disease.|||months||95% Confidence Interval|Median
1291553|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Number of Events|An overall survival event was death due to any cause.|From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).|ITT patients with Stage III disease.|||participants|||Number
1292333|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1460 days||||percentage of participants|||Number
1291554|NCT00112918|Primary|Disease-free Survival in Stage III Cancer Patients - Number of Events|A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.|From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).|The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.|||participants|||Number
1291555|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Time to Event|Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.|From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).|ITT patients with Stage III disease.|||months||95% Confidence Interval|Median
1291556|NCT00112918|Primary|Disease-free Survival in Stage III Cancer Patients - Time to Event|Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1.|From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).|The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.|||months||95% Confidence Interval|Median
1291557|NCT00112905|Secondary|Best Overall Response by RECIST|"This outcome measure reports the best response a patient has ever experienced.~<Target Lesions>~Complete Response (CR):~The disappearance of all target lesions, confirmed by assessments >=4 weeks (wks) later.~Partial Response:~>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments >=4 wks later.~Progressive Disease (PD):~>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions.~Stable Disease (SD):~Neither response criteria nor progressive disease criteria are met for >=8 wks.~<Nontarget Lesions>~CR:~The disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments >=4 wks later.~SD:~Persistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for >=8 wks.~PD:~The appearance of new lesions or unequivocal progression of existing lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in the analysis.|||Participants|||Number
1291558|NCT00112905|Secondary|Overall Survival|Time from registration to death. Patients alive at last follow-up were censored.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in this analysis.|||Months||90% Confidence Interval|Median
1291559|NCT00112905|Secondary|Progression-free Survival|"Time from registration to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in this analysis.|||Months||90% Confidence Interval|Median
1291560|NCT00112905|Primary|Kaplan-Meier Estimate of Progression-free Survival at 4 Months|"Survival estimate from the Kaplan-Meier curve of the proportion of patients alive and progression-free at 4 months.~Progression-free survival is defined as the time from registration to progression or death, whichever occurs first.~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Per protocol, the primary analysis included eligible patients who started protocol treatment.|||Percentage of Participants||90% Confidence Interval|Number
1291561|NCT00112866|Other Pre-specified|Overall Progression Free Survival|Kaplan-meier curve|1 year|Overall survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the this objective.|||weeks||95% Confidence Interval|Median
1291562|NCT00112866|Secondary|Tumor Tissue Concentrations|a section of tumor of approximately 500mg will be snap frozen (immediately prepared and frozen) once removed from brain for analysis of the drug concentration in contrast -enhancing tumor.|at time of surgery|8 500mg dose tissue samples and 10 2000mg dose tissue samples were either too small or had large areas of necrosis and gliosis to do analysis/evaluation|||ng/g||Standard Deviation|Mean
1291563|NCT00112866|Secondary|Plasma Concentration of EMD 121974|24 hour post dose concentration plasma, at time of resection|24 hour post concentration|6 of 8 and 7 of 11 plasma samples at the 500mg and 2000mg dose level respectively, were below the lower level of quantitation (LLOQ) Of the 15 samples in the low dose group only 8 were evaluable and 11 of the 15 for the high dose group. Samples were either damaged or too small for analysis.|||ng/ml||Standard Deviation|Mean
1291564|NCT00112866|Secondary|Changes in Endothelial Cell Apoptosis|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and up to 4 years|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis||||||
1291565|NCT00112866|Secondary|Changes in Tumor Cell Proliferation|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis||||||
1291566|NCT00112866|Secondary|Changes in Tumor Cell Apoptosis|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis||||||
1291567|NCT00112866|Secondary|Changes in Vitronectin Expression|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis||||||
1291568|NCT00112866|Secondary|Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher’s Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations after cilengitide treatments were planned as a component of this clinical trial, unfortunately, the majority of tumor samples were too small to do both measures of drug and molecular analysis or the sample was inadequate for both after removal of areas of necrosis and gliosis||||||
1291569|NCT00112866|Primary|6m-Progression-free Survival|progression within 6 months (26 weeks) of treatment|6 months|6months progression free survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the primary objective.|||percent|||Number
1291570|NCT00112840|Secondary|Overall Survival (Phase I and II)|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Up to 3 years from study registration|All eligible participants were used for this endpoint.|||months||95% Confidence Interval|Median
1291571|NCT00112840|Secondary|Time to Progression (Phase II)|The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Up to 3 years from study registration|All eligible participants in Phase II were used for this endpoint.|||months||95% Confidence Interval|Median
1291572|NCT00112840|Secondary|Clinical Best Response Rate of CCI-779 and Bevacizumab in Patients With Metastatic Renal Cell (Phase II)|"The number of participants with clinical tumor response to treatment will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 3 years from study registration|All eligible Phase II patients were used to assess this endpoint.|||percentage of participants|||Number
1291573|NCT00112840|Primary|Proportion of Progression-free Patients at 6 Months (Phase II)|Determination of progression will be made according to Response Evaluation Criteria in Solid Tumors (RECIST). A progression (PD) is defined as having at least a 20% increase in the sum of the longest dimension of target lesions taking as reference the smallest sum of the largest dimension recorded at baseline.The proportion of progression-free patients will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the success proportion will be calculated. All patients meeting the eligibility criteria who have signed a consent form and begun treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.|6 months after study entry|Only Phase II participants were analyzed for this endpoint. Forty participants from Phase II were evaluable for this endpoint.|||percentage of participants||95% Confidence Interval|Number
1291574|NCT00112840|Primary|Dose-limiting Toxicity (DLT) (Phase I)|"For this protocol, dose limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment in the first four weeks of combination therapy, and meeting the following criteria:~Grade 4 Absolute neutrophil count (ANC) for 5+ days.~Grade 4 anemia or thrombocytopenia of any duration.~Serum Creatinine 2 times baseline or 2x upper limit of normal if baseline levels not normal.~Any other non-hematologic grade 3 or higher as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, except fatigue and grade 3 Hypertension that is will be controlled with oral medication.~Grade 3 triglycerides will be a DLT for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.~The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose where 1 or 0 out of 6 patients experience DLT with the next higher dose."|Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles.||||participants|||Number
1291575|NCT00112736|Primary|Progression-free Survival at 6 Months (Phase II)|"Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).~Responses had to be present on 2 consecutive scans and were centrally reviewed."|Evaluated at baseline and every other cycle, till Month 6|Primary endpoint PFS6 date of registration; Sample size chosen to discriminate between 15% & 35% PFS6 rates for GBM patients. With accrual 32 GBM patients, trial would be considered successful if 8 achieved PFS6. This yields 0.92 power to detect a 35% PFS6 rate, with 0.90 probability of rejecting the treatment regimen if the PFS6 rate is only 15%.|||participants|||Number
1291576|NCT00112736|Primary|Pharmacokinetics (Phase I)|"Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels~blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1~Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration"|Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration|per protocol|||ng/mL||Standard Deviation|Mean
1291577|NCT00112736|Primary|Efficacy - Response Phase 1|"pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan.~Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): >= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer)."|at least 8 weeks of treatment|Response was reviewed only in those patients treated at the MTD (15mg temsirolimus)|||participants|||Number
1291578|NCT00112736|Primary|Safety/Dose Limiting Toxities Phase I|"Dose limiting toxities defined as: grade 3 thrombocytopenia, grade 4 anemia and neutropenia, grade >/= nonhematologic toxicity, and failure to recover from toxicites to be eligible for retreatment in 2 weeks of the last dose of either drug. Also grade 3 nonhematologic toxicities only if they wre refractory to maxiaml medical therapy.~MTD defined as dose at which fewer than one-third of patients experienced a DLT~Outcome measure defines number of participants who had a defined dose limiting toxicity."|first 4 weeks of treatment||||participants|||Number
1291579|NCT00112736|Primary|Maximum Tolerated Dose (Phase I)|"Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed.~3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg"|based on first 4 weeks of treatment - cycle 1|Per protocol -|||mg|||Number
1291580|NCT00112723|Secondary|Pharmacokinetics (Cmax) of Flavopiridol|Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1||||μM||Standard Deviation|Mean
1291581|NCT00112723|Secondary|Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs).|The correlation of the pharmacodynamic effects of flavopiridol on normal peripheral blood mononuclear cells (PBMCs)|Day 1|Data not available due to studies were not conducted by collaborating laboratory Investigator||||||
1291582|NCT00112723|Secondary|Induced Response in Patients Independent of p53 Mutational Status|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years|Data not available due to studies were not conducted by collaborating laboratory Investigator||||||
1291583|NCT00112723|Secondary|Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)||Up to 30 days after completion of study treatment||||patients|||Number
1291584|NCT00112723|Secondary|Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol|Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1|total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment|||hr×μM||Standard Deviation|Mean
1291585|NCT00112723|Primary|Lymphoid/Plasma Cell Malignancies|Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.|Up to 2 years|Response indicated for Indolent B-cell NHL, Mantle cell NHL and T-cell NHL|||patients|||Number
1291586|NCT00112723|Primary|Qualitative and Quantitative Toxicities in Regard to Organ Specificity|The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.|Up to 30 days after completion of study treatment|Grade 3 and 4 toxicities.|||percentage of patients|||Number
1291587|NCT00112723|Primary|Complete and Partial Response Rate (Phase II)|Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.|Up to 2 years|Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL|||patients|||Number
1291588|NCT00112723|Primary|Maximum Tolerated Dose (MTD)|The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.|28 days||||mg/m2|||Number
1291589|NCT00112723|Primary|Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)|Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.|28 days||||patients|||Number
1291590|NCT00112671|Secondary|Frequency of Common Grade 3 Adverse Events|Will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 5 years||||common grade 3 events|||Number
1291630|NCT00112437|Secondary|Percentage Change From Baseline in Total Body BMD at 24 Months|Percentage change in total body BMD (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward. No data was carried forward from the core to the extension period.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291591|NCT00112671|Secondary|Progression-free Survival|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Survival estimates will be computed using the Kaplan-Meier method. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated.|From start of treatment to progression or death, assessed up to 1 year|3 months progression free survival|||percentage of participants||95% Confidence Interval|Median
1291592|NCT00112671|Secondary|Time to Progression|Progression is defined using the Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.|Up to 5 years||||months||95% Confidence Interval|Median
1291593|NCT00112671|Secondary|Number of Participants With Stable Disease for More Than 3 Months|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From the start of the treatment until the criteria for progression are met, up to 5 years|Stable disease for more than 3 months|||participants|||Number
1291594|NCT00112671|Primary|Number of Paricipants With Tumour Response Defined as Partial or Complete Response Per the RECIST 1.0 Criteria|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 5 years||||participants|||Number
1291595|NCT00112593|Secondary|Reconstitution of HIV-specific Immunity||Up to 1 year||||Participants|||Count of Participants
1291596|NCT00112593|Secondary|Progression of HIV|Count of participants with HIV progression.|Within 1 year||||Participants|||Count of Participants
1291597|NCT00112593|Secondary|Overall Survival|Kaplan-Meier estimate assessed at 1 year.|Up to 1 year||||survival probability||95% Confidence Interval|Number
1291598|NCT00112593|Primary|Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin|Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor.|Up to day 80||||Participants|||Count of Participants
1291599|NCT00112593|Primary|Death From GVHD||Within the first 360 days||||Participants|||Count of Participants
1291600|NCT00112593|Primary|Death From Regimen Toxicity or Opportunistic Infection||Within the first 100 days||||Participants|||Count of Participants
1291601|NCT00112489|Primary|Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response|"Primary outcome measured according to RECIST v1.0 Best Response:~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Response was measured every other cycle (q 6 weeks) until disease progression is documented.|Total eligible and treated participants|||participants|||Number
1291602|NCT00112489|Primary|Nature and Degree of Toxicity|Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0|During study treatment and up to 30 days after stopping study treatment|Eligible and Evaluable patients|||Participants|||Count of Participants
1291603|NCT00112463|Secondary|Survival|Months from first treatment until death or the last date of contact|Max of 98 months|All treated participants|||months||95% Confidence Interval|Median
1291604|NCT00112463|Primary|Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3|"The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study.~A summary of the individual toxicities can be found in the AE/SAE results."|During treatment (max of 16 months) and for 1 month following treatment|All treated participants|||Participants|||Count of Participants
1291605|NCT00112463|Primary|Time to Progression|Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.|Until disease progression - max of 48 months|All treated participants|||months||95% Confidence Interval|Median
1291606|NCT00112463|Primary|Objective Tumor Response (Complete and Partial)|Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR|While on treatment - max of 16 months|Participants who were evaluable for response|||Participants|||Count of Participants
1292334|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1095 days||||percentage of participants|||Number
1291607|NCT00112437|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Years 6-10 (up to 60 months)|All participants who received at least 1 administration of the trial drug during treatment years 6-10.|||Participants|||Number
1291608|NCT00112437|Primary|Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug)|All participants who received at least 1 administration of the trial drug during treatment years 6-10|||Participants|||Number
1291609|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine BMD at 120 Months|Percentage change from baseline in lumbar spine BMD at 120 Months.|Baseline and Month 120|This analysis was based on the FAS population, which included all randomized participants who took at least 1 dose of extension study drug and had the necessary extension data available for this endpoint. Missing data were not imputed.|||Percentage Change||95% Confidence Interval|Mean
1291610|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine BMD at 60 Months|Percentage change from baseline in lumbar spine BMD at 60 months.|Baseline and Month 60|All participants who took at least one dose of base study medication and at least one dose of extension medication. Missing values were imputed using last observation-carried-forward principle.|||Percentage change||95% Confidence Interval|Mean
1291611|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291612|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (serum bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291613|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291614|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.|||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
1291615|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover u-DPyr at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291616|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (s-CTx) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291617|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (u-NTx) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291629|NCT00112437|Secondary|Percentage Change From Baseline in Distal Forearm BMD at 24 Months|Percentage change in distal forearm BMD (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291618|NCT00112437|Secondary|Percentage Change From Baseline in Distal Forearm BMD at 36 Months|Percentage change in distal forearm BMD (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1291619|NCT00112437|Secondary|Percentage Change From Baseline in Total Body BMD at 36 Months|Percentage change from baseline in total body BMD (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291620|NCT00112437|Secondary|Percentage Change From Baseline in Trochanter BMD at 36 Months|Percentage change in trochanter BMD (relative to baseline) at 36 months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1291621|NCT00112437|Secondary|Percentage Change From Baseline in Femoral Neck BMD at 36 Months|Percentage change in femoral neck BMD (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291622|NCT00112437|Secondary|Percentage Change From Baseline in Total Hip BMD at 36 Months|Percentage change in total hip BMD (relative to baseline) at 36 months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291623|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine BMD at 36 Months|Percentage change in lumbar spine BMD (relative to baseline) at 36 months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percent Change||95% Confidence Interval|Least Squares Mean
1291624|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months|Back-transformation (geometric mean) of the least squares mean of the log-values percentage change from baseline in biochemical marker of bone turnover (s-P1NP) (relative to baseline) at 24 months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
1291625|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
1291626|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
1291627|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291628|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (u-NTx) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1292754|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1291631|NCT00112437|Secondary|Percentage Change From Baseline in Trochanter BMD at 24 Months|Percentage change from baseline in trochanter BMD (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1291632|NCT00112437|Secondary|Percentage Change From Baseline in Femoral Neck BMD at 24 Months|Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291633|NCT00112437|Secondary|Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months|Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291634|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291635|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291636|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291637|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months|Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.|Baseline and 12 Months|This analysis was a geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291638|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months|Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months|Baseline and 12 Months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291639|NCT00112437|Secondary|Percentage Change From Baseline in Distal Forearm BMD at 12 Months|Percentage change in distal forearm BMD (relative to baseline) at 12 months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward|||Percentage change||95% Confidence Interval|Least Squares Mean
1291640|NCT00112437|Secondary|Percentage Change From Baseline in Total Body BMD at 12 Months|Percentage change in total body BMD (relative to baseline) at 12 months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291641|NCT00112437|Secondary|Percentage Change From Baseline in Trochanter BMD at 12 Months|Percentage change in trochanter BMD (relative to baseline) at 12 months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291642|NCT00112437|Secondary|Percentage Change From Baseline in Femoral Neck BMD at 12 Months|Percentage change in femoral neck BMD (relative to baseline) at 12 months|Baseline and 12 months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291643|NCT00112437|Secondary|Percentage Change From Baseline in Total Hip BMD at 12 Months|Percentage change in total hip BMD (relative to baseline) at 12 months|Baseline and 12 months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1291644|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine BMD at 24 Months|Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.|Baseline and 24 months|Analysis on lumbar spine BMD (g/cm2) at Month 24 used the Full-Analysis-Set Population with Last Observation Carried Forward from Month 18 to 24. No data were carried forward from the core to the extension period. Only patients who took at least one dose of extension medication were included. 17 patients were excluded from FAS.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1291645|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.|Baseline and 12 months|Analysis at Month 12 used Full-Analysis-Set Population of participants who took at least one dose of study medication and had necessary follow-up information, in their randomization treatment group, with last observation data carried forward. Seven patients had a baseline value, but no value at Month 12 for lumbar spine Bone Mineral Density.|||Percentage change||95% Confidence Interval|Least Squares Mean
1291646|NCT00112385|Secondary|Average Daily Dose of Prednisone From Baseline to Week 52|The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.|Baseline through Week 52||||mg||Standard Deviation|Mean
1291647|NCT00112385|Primary|Average Cumulative Dosage of Prednisone Over the One Year Study Period|The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group.|Baseline until week 52||||mg||Standard Deviation|Mean
1291648|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52."|Screening visit, Week 12, 24, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291649|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52."|At Screening, Week 12, 24, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291650|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit."|Screening visit and Week 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291651|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291652|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291653|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291654|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291655|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291656|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291657|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291658|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291724|NCT00112112|Secondary|Influenza A/H3N2 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291659|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291660|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291661|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291662|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291663|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline.~Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291664|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
1291725|NCT00112112|Secondary|Influenza A/H1N1 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291665|NCT00112385|Primary|Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.|"The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Kilograms||Standard Deviation|Mean
1291666|NCT00112385|Primary|Average Change in Pulse Comparing Baseline to Week 52|"The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||beats per minute||Standard Deviation|Mean
1291667|NCT00112385|Primary|Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.|"The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||mmHg||Standard Deviation|Mean
1291668|NCT00112385|Primary|Average Change in Systolic Blood Pressure From Baseline to Week 52|"The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||mmHg||Standard Deviation|Mean
1291669|NCT00112385|Primary|Average Change in Respiration Rate From Baseline to Week 52|"The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||breaths per minute||Standard Deviation|Mean
1291670|NCT00112385|Primary|Average Change in Oral Temperature From Baseline to Week 52|"The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week 0) and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||degrees Celsius||Standard Deviation|Mean
1291671|NCT00112385|Other Pre-specified|Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52|"Average change in percent predicted Diffusion Capacity (DLCO)from the Screening Visit to Week 52 was calculate. The average change was determined by subtracting the Screening test results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed during the Week 24 visit."|Screening visit and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||Percent predicted||Standard Deviation|Mean
1291672|NCT00112385|Other Pre-specified|Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52|"The average change in percent predicted Forced Expiratory Volume in 1 second (FEV1) from Screening to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed during the Week 24 visit."|Screening Visit and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||Percent predicted||Standard Deviation|Mean
1291726|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin M (IgM)|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1297092|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 4||Baseline to Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1291673|NCT00112385|Other Pre-specified|Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52.|"The average change in percent predicted Forced Vital Capacity (FVC) from the Screening Visit to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed at the Week 24 visit."|Screening Visit and Week 52.|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||Percent predicted||Standard Deviation|Mean
1291674|NCT00112385|Other Pre-specified|Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52|"The Health Assessment Questionnaire (HAQ)was completed by subjects to assess the affects of their illness on the ability to function in daily life. The HAQ consists of 8 sections. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do).The 8 scores of the 8 sections are summed and divided by 8. A higher score indicates more impairment.~The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Units on a scale||Standard Deviation|Mean
1291675|NCT00112385|Other Pre-specified|Change in Pruritis Rating From Baseline to Week 52|"This is the average change in pruritis score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived level of pruritis (itchiness). A score of 0 cm indicated Not itchy at all. A score of 10.0 cm indicated Extremely itchy.~This assessment was also completed at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0), and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||cm||Standard Deviation|Mean
1291676|NCT00112385|Other Pre-specified|Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline|"Average change in Cutaneous Disease Activity and Severity Index (CDASI) score from Baseline to Week 52. The assessment graded the severity of the subject's rash. The rash was rated using a a 4-point scale with a score of 0 indicating no rash. The score was added together using all 13 anatomical locations included on the assessment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Units on a scale||Standard Deviation|Mean
1291677|NCT00112385|Other Pre-specified|Average Change in Patient Global Activity Assessment Score From Baseline to Week 52|"Average change in Patient Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease.~This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||cm||Standard Deviation|Mean
1291678|NCT00112385|Other Pre-specified|Average Change in Physician Global Activity Assessment From Baseline to Week 52|"Average change in Physician Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||cm||Standard Deviation|Mean
1291679|NCT00112385|Other Pre-specified|Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52|The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the lumbar spine was calculated comparing the results from the Screening visit to Week 52. The average change was determined by subtracting the Screening Visit (Week <8)test results from the Week 52 results (Week 52- screening Visit). The Screening visit occurred within 8 weeks of the Baseline visit.|Screening visit and Week 52.|Data for all subjects enrolled in the trial are not available for this assessment. One subject left the study early and one subject was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.|||Z-Score||Standard Deviation|Mean
1291680|NCT00112385|Other Pre-specified|Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52|"The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the femur from the Screening visit to the Week 52 visit was calculated. The average change was determined by subtracting the Screening Visit test results from the Week 52 results (Week 52- Screening visit).~The Screening visit was conducted within 8 weeks of the Baseline visit."|Screening and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||Z-score||Standard Deviation|Mean
1291727|NCT00112112|Secondary|Influenza B IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291681|NCT00112385|Other Pre-specified|Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52|"Average change in time to walk 30 feet comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Seconds||Standard Deviation|Mean
1291682|NCT00112385|Other Pre-specified|Average Change in Time to Rise From a Chair From Baseline to Week 52|"The Average change in time to rise from a chair comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Seconds||Standard Deviation|Mean
1291683|NCT00112385|Primary|Tolerability|The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment.|At any point between Baseline (week 0) and the end of the study (Week 52)||||Participants|||Number
1291684|NCT00112385|Other Pre-specified|Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52|"The Manual Muscle Test (MMT) assesses 26 muscle groups. The muscle strength of each muscle group is graded. The score for each muscle group ranges from 0 (No contraction palpable) to 5 (normal strength). The minimum total MMT score is a 0. The maximum total MMT score is a 130.~The average change in the average Manual Muscle Testing (MMT)from Baseline to Week 52 was calculated. The average score is composed of 26 muscle groups that were tested. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline)."|At Baseline (Week 0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Units on a scale||Standard Deviation|Mean
1291685|NCT00112385|Secondary|Average Prednisone Dosage After Week 24|We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52).|from week 24 to 52||||mg||Inter-Quartile Range|Median
1291686|NCT00112385|Other Pre-specified|The Number of Participants Who Were Classified as Treatment Failures|Treatment failures were determined based on criteria from the study protocol using objective and subjective ratings from the study physician. If the study physician felt that the rate of prednisone taper needed to be reduced, the prednisone dose needed to be increased or restarted, or a second-line agent added, the patient will be considered to be a treatment failure.|At any point during the 52 week study||||participants|||Number
1291687|NCT00112385|Primary|Occurrence of at Least One Adverse Event|"Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of mild, moderate or severe matches with the descriptions from the CTCAE dictionary.~In general, a Mild AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated.~A Moderate AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living.~A Severe AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling;"|at each visit during the 12 month study|Intention- to -Treat (ITT)|||participants|||Number
1291688|NCT00112359|Other Pre-specified|Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||μg/mL|Participants||Number
1291689|NCT00112359|Secondary|Number of Participants Hospitalized at Least Once Between Day 0 and Day 42|Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF.|Day 0 to Day 42|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||participants|||Number
1291690|NCT00112359|Primary|Change in CFQ-R Respiratory Symptoms Scale (RSS) Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 28|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.|||units on a scale||Standard Error|Least Squares Mean
1291691|NCT00112359|Secondary|Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug|Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF.|Day 0 to Day 42|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received.|||participants|||Number
1291728|NCT00112112|Secondary|Influenza B IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291692|NCT00112359|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum|Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of 1 dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
1291693|NCT00112359|Secondary|Percent Change in FEV1 (L)|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28.|Day 0 to Day 28|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.|||Percent change in FEV1 (L)||Standard Error|Least Squares Mean
1291694|NCT00112359|Other Pre-specified|Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 0|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||μg/mL|Participants||Number
1291695|NCT00112359|Other Pre-specified|Number of Participants With Other Pathogens Present|Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||participants|||Number
1291696|NCT00112359|Secondary|Change in CFQ-R RSS Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 42|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.|||units on a scale||Standard Error|Least Squares Mean
1291697|NCT00112359|Secondary|Change in CFQ-R RSS Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 14|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.|||units on a scale||Standard Error|Least Squares Mean
1291698|NCT00112294|Secondary|Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures|Participants were to complete log to collect information on unscheduled visits to physicians,clinics,hospitals & other unscheduled major procedures.If asked, participants were to complete and return log to site upon routinely scheduled visits.The purpose of this exploratory analysis was to understand the economical implications as a secondary objective.This was not a pivotal study & therefore not needed to support any arguments with regulatory authorities concerning cost-benefit,hence,it was not necessary to conduct this analysis. There is no intent on conducting this analysis in the future.|Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).|This analysis was not performed.||||||
1291699|NCT00112294|Secondary|Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants|Abnormalities were graded according to the NCI CTC, version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Hyperglycemia (non-fasting): Grade 3, serum glucose >13.9 – 27.8 mmol/L; Grade 4 >27.8 mmol/L or acidosis. Hypomagnesemia: Grade 3, serum magnesium >1.23 – 3.30 mmol/L; Grade 4 >3.30 mmol/L. Hyponatremia: Grade 3, serum sodium <130 – 120 mmol/L; Grade 4 <120 mmol/L. Low albumin: Grade 3, serum albumin <20 g/L; Grade 4 not applicable.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
1291700|NCT00112294|Other Pre-specified|Median Change From Baseline in Symptoms, by Time Point|Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). The median change from baseline score was calculated at 3-weekly intervals. See also Outcome Measure 8.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed a baseline FACT-LCS questionnaire (ie, completed questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization). n = number of participants with a score at both the baseline and at the specified time point (each arm respectively).|||Units on a scale||Inter-Quartile Range|Median
1291729|NCT00112112|Secondary|Influenza A/H3N2 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291701|NCT00112294|Secondary|Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants|Abnormalities were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Neutropenia: Grade 3, neutrophils <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Leukopenia: Grade 3, leukocytes <2.0 – 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L. Thrombocytopenia: Grade 3, platelets <50.0 – 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Anemia: Grade 3, hemoglobin <4.9 – 4.0 millimoles (mmol)/L, Grade 4, <4.0 mmol/L.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
1291702|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Cardiac AEs|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term “cardiac AE” were of particular importance. These AEs, coded as preferred or other level Medical Dictionary for Regulatory Activities [MedDRA] terms were: coronary artery disorders, cardiac arrhythmias, heart failures not elsewhere classified, left ventricular failures, sudden cardiac death, cardiac death and sudden death.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
1291703|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Infusion Reaction|"AE=any new untoward medical occurrence or worsening of pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term infusion reaction were of particular importance. These AEs were: infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction regardless of when they occurred. The terms dyspnea, pyrexia and chills were also grouped under infusion reaction, provided the onset date of these toxicities occurred on the first day of study treatment."|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
1291704|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Acneform Rash|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term “acneform rash” were of particular importance. These AEs were: rash, rash pustular, rash erythematous, dermatitis acneiform, dermatitis exfoliative, rash papular, rash pruritic, rash generalised, rash macular, rash maculo-papular, acne, acne pustular, skin desquamation and dry skin.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
1291705|NCT00112294|Secondary|Number of Participants Experiencing AEs Leading to Study Drug Discontinuation|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). The results presented are stratified according to which drug was discontinued.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||participants|||Number
1291706|NCT00112294|Secondary|Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants. The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|||Participants|||Number
1291707|NCT00112294|Secondary|Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)|Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). Symptomatic progression was defined as >= 2-point decrease from baseline in score (maintained for 2 consecutive assessments at least 3 weeks apart). Time to symptomatic progression was defined as the time from randomization to date of symptoms worsening. For participants with no symptom progression, the date of the last symptom assessment was used. See also Outcome Measure 15.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed baseline FACT-LCS questionnaire (ie, completed questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization) and who had a baseline score greater than or equal to 2. As the median was not reached, no data are presented here (see Outcome Measure 15).||||||
1291708|NCT00112294|Secondary|Number of Participants With Improvement of Symptoms|Symptoms were assessed using the Functional Assessment of Cancer Therapy – Lung Cancer Subscale (FACT-LCS) questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic in all symptoms assessed) to 28 (symptom-free on all symptoms assessed). Symptom response (improvement) was defined as >= 2-point increase from baseline in score (maintained for 2 consecutive assessments, at least 3 weeks apart). Participants with a baseline score of >= 27 were not evaluable, as it would not have been possible to show an improvement. Participants with no baseline data were also not evaluable.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed a baseline FACT-LCS questionnaire (ie, who completed a questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization) and who had a baseline score of 26 or less.|||Participants|||Number
1291709|NCT00112294|Secondary|Median Number of Months of Survival|The median number of months of survival was defined as the time from randomization to the date of death. For participants who did not die, the date of last contact was used.|From randomization to death or date of last contact (up to 41 months).|All randomized participants (intention to treat population).|||Months||95% Confidence Interval|Median
1291730|NCT00112112|Secondary|Influenza A/H3N2 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291710|NCT00112294|Secondary|Median Number of Months to Response|The median number of months to response was calculated for participants whose best response was CR or PR. It was defined as the time from the first dose of study therapy to the first date that criteria for PR or CR (whichever occurred first)were met. Response was assessed by the IRRC, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.|Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).|All randomized participants with a best response of CR or PR.|||Months||Full Range|Median
1291711|NCT00112294|Secondary|Median Number of Months of Response|Median number of months of response (time from first occurrence of CR/PR to date of PD/death, [per IRRC assessment,using modified WHO criteria]) calculated for participants whose best response=CR/PR.For participants who did not progress/die, date of last tumor assessment used.CR:disappearance of all index/non-index lesions;PR:>= 50% reduction in SOPD of index lesions compared with baseline, no evidence of progression.No new lesions present.PD:>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion.|Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).|All randomized participants with a best response of CR or PR.|||Months||95% Confidence Interval|Median
1291712|NCT00112294|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)|Disease control was defined as the number of participants whose best response was CR, PR, or SD, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR:>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression (to qualify as CR or PR, no new lesions could be present); SD: participants who did not meet the criteria for CR, PR, or PD (PD:>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion).|From randomization to end of study drug therapy (up to 174 weeks).|All randomized participants (intention to treat population).|||Participants|||Number
1291713|NCT00112294|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.|From randomization to end of study drug therapy (up to 174 weeks).|All randomized participants (intention to treat population).|||Participants|||Number
1291714|NCT00112294|Primary|Median Number of Months of Progression-free Survival (PFS)|Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.|From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).|All randomized participants (intention to treat population).|||Months||95% Confidence Interval|Median
1291715|NCT00112151|Secondary|Fat Free Mass (kg)|Total change in Fat free mass (kg) as evaluated by DXA|Baseline and 12 months||||kg||Standard Deviation|Mean
1291716|NCT00112151|Secondary|Fat Mass (kg)|Total change in Fat mass (kg) as evaluated by DXA|Baseline and 12 months||||kg||Standard Deviation|Mean
1291717|NCT00112151|Secondary|Power (Power Rig, Watts)|Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).|Baseline and 12 months||||Watts||Standard Deviation|Mean
1291718|NCT00112151|Secondary|Lower Body Muscle Strength (1-RM, kg)|The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.|Baseline and 12 months||||kg||Standard Deviation|Mean
1291719|NCT00112151|Secondary|Upper Body Muscle Strength (1-RM, kg)|The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.|Baseline and 12 months||||kg||Standard Deviation|Mean
1291720|NCT00112151|Primary|Physical Function (CS-PFP Total Score)|Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
1291721|NCT00112112|Secondary|Influenza B IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291722|NCT00112112|Secondary|Influenza B IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291723|NCT00112112|Secondary|Influenza A/H3N2 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1293659|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 12|Laboratory hematology lymphocytes|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
1291731|NCT00112112|Secondary|Influenza A/H1N1 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291732|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin G (IgG)|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291733|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils|Mean and standard deviation results of absolute neutrophils subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Cells per 10^3/UL||Standard Deviation|Mean
1291734|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes|Mean and standard deviation results of absolute lymphocytes subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Cells per 10^3/UL||Standard Deviation|Mean
1291735|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes|Mean and standard deviation results of absolute lymphocytes subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Cells per 10^3/UL||Standard Deviation|Mean
1291736|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes|Mean and standard deviation results of lymphocytes subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
1291737|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes|Mean and standard deviation results of lymphocytes subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
1291738|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells|Mean and standard deviation results of white blood cells subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^3/UL||Standard Deviation|Mean
1291739|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells|Mean and standard deviation results of white blood cells subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^3/UL||Standard Deviation|Mean
1291740|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD56|Mean and standard deviation results of CD56 lymphocyte subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percent of lymphocytes||Standard Deviation|Mean
1291741|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD56|Mean and standard deviation results of CD56 lymphocyte subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percent of lymphocytes||Standard Deviation|Mean
1291742|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291743|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291744|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291745|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291746|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291747|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291748|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291749|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291750|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291751|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291752|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291753|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291754|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291755|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291756|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin A (IgA)|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
1291757|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
1291758|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
1291759|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
1291760|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
1291761|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
1291762|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
1291763|NCT00112112|Secondary|HLA Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
1291764|NCT00112112|Secondary|HLA Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
1291765|NCT00112112|Secondary|Human Leukocyte Antigen (HLA) Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
1291766|NCT00112112|Secondary|IL-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
1291767|NCT00112112|Secondary|IL-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
1291768|NCT00112112|Secondary|Interleukin (IL)-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
1291769|NCT00112112|Secondary|INF-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
1291770|NCT00112112|Secondary|INF-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
1291771|NCT00112112|Secondary|Interferon (INF)-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
1291772|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD8|Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
1291773|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD4|Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
1291774|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD3|Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
1291775|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD19|Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
1291776|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD8|Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
1291924|NCT00110890|Primary|Number of Participants With Mean PTH ≤ 300 pg/mL|Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
1291777|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD4|Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
1291778|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD3|Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
1291779|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19|Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
1291780|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|Unscheduled visits occurring during 0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|participants w/unsched. illness visits||Number
1291781|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.|35-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
1291782|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|14-28 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
1291783|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|7-10 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
1291784|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|3-5 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
1291785|NCT00112112|Primary|Number of Significant New Medical Conditions (SNMCs)|A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.|43-180 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||events|||Number
1291786|NCT00112112|Primary|Number of Participants Who Had Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
1291787|NCT00112112|Primary|Number of Participants Who Had Serious Adverse Events (SAEs)|An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.|0-180 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||Participants|||Number
1291788|NCT00112112|Primary|Number of Participants Who Had Reactogenicity Events (REs)|Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.|0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs. One participant in FluMist group did not have any RE data and was excluded from the RE analysis.|||participants|||Number
1291789|NCT00112047|Secondary|Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population).|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Composite Score||Standard Deviation|Mean
1291790|NCT00112047|Secondary|Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population).|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Composite Score||Standard Deviation|Mean
1291791|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
1291792|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
1291793|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
1291794|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
1291795|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
1291796|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||total body fat (kg)||Standard Deviation|Mean
1291797|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||trunk fat (kg)||Standard Deviation|Mean
1291798|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||limb fat (kg)||Standard Deviation|Mean
1291799|NCT00112047|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)|Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value|Study/Atripla baseline to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||CD4 Cell count (Cells/mm^3)||Standard Deviation|Mean
1291800|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 240 (Atripla Week 96)|"MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).~Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)"|||Percentage of Participants|||Number
1291801|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 240 (Atripla Week 96)|"MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).~Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)"|||Percentage of Participants|||Number
1292335|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 730 days||||percentage of participants|||Number
1291802|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
1291803|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
1291804|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
1291805|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
1291806|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit.|Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
1291807|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit.|Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set (all participants who received at least one dose of Atripla). Data collected after permanent discontinuation of the study regimen was excluded from this analysis set.|||Percentage of Participants|||Number
1291808|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)|||total body fat (kg)||Standard Deviation|Mean
1291809|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)|||trunk fat (kg)||Standard Deviation|Mean
1291810|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine limb fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)|||limb fat (kg)||Standard Deviation|Mean
1291811|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144|Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value|Baseline to Week 144|AT analysis set|||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
1291812|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144|Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 144|AT analysis set|||Log10 c/mL||Standard Deviation|Mean
1291813|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 144|MITT|||Percentage of Participants|||Number
1291814|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 144|MITT|||Percentage of participants|||Number
1292336|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 365 days||||percentage of participants|||Number
1291815|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144|MITT|||Percentage of Participants|||Number
1291816|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144|MITT|||Percentage of Participants|||Number
1291817|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|Week 144|ITT Analysis set (Missing Observation or Switch in ART=Failure)|||Percentage of Participants|||Number
1291818|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|Week 144|ITT Analysis set|||Percentage of Participants|||Number
1291819|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit.|Week 144|Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 458).|||Percentage of participants|||Number
1291820|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit.|144 weeks|Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 456).|||Percentage of Participants|||Number
1291821|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value|48 weeks to 96 weeks|ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set for limb fat analyses: 93)|||total body fat (kg)||Standard Deviation|Mean
1291822|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value|Week 48 to Week 96|ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)|||trunk fat (kg)||Standard Deviation|Mean
1291823|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value.|Week 48 to Week 96|ITT (whole body dual-energy X-ray absorptiometry [DEXA] scans to determine limb fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)|||limb fat (kg)||Standard Deviation|Mean
1291824|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96|Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value|Baseline to Week 96|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.|||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
1291825|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96|Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 96|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.|||Log10 c/mL||Standard Deviation|Mean
1291826|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 96|MITT|||Percentage of Participants|||Number
1291827|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 96|MITT|||Percentage of Participants|||Number
1292138|NCT00108862|Secondary|Percent of Participants Who Interrupted or Discontinued at Least One Tuberculosis (TB) Medication Due to Toxicity.|All eligible participants were included in this analysis. The percent of participants who interrupted at least one TB medication for more than one day due to toxicity or discontinued at least one TB medication due to toxicity was calculated with an associated standard error.|Through week 48||||percent of participants||95% Confidence Interval|Number
1291828|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 96|MITT|||Percentage of Participants|||Number
1291829|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96|TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1.|Week 96|MITT|||Percentage of Participants|||Number
1291830|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit.|Week 96|Week 96 efficacy analysis excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [465])|||Percentage of Participants|||Number
1291831|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit.|96 Weeks|Week 96 efficacy analysis set excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [463])|||Percentage of Participants|||Number
1291832|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value|Study baseline to Week 48|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.|||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
1291833|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48|Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 48|As treated (AT) analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.|||Log10 c/mL||Standard Deviation|Mean
1291834|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Baseline to 48 Weeks|ITT analysis set|||Percentage of participants|||Number
1291835|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Baseline to 48 Weeks|ITT analysis set|||Percentage of Participants|||Number
1291836|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Baseline to 48 Weeks|ITT analysis set|||Percentage of Participants|||Number
1291837|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Baseline to 48 weeks|ITT analysis set|||Percentage of Participants|||Number
1291838|NCT00112047|Secondary|Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|48 Weeks|ITT analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).|||Percentage of Participants|||Number
1292337|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1825 days||||percentage of partcipants|||Number
1291839|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|48 weeks|Intention to Treat (ITT) analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).|||Percentage of Participants|||Number
1291840|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit.|Week 48|MITT analysis set included all randomized participants who received at least one dose of study medication, had no major protocol violations, and no baseline primary NNRTI resistance mutations (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])|||Percentage of Participants|||Number
1291841|NCT00112047|Primary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit.|48 weeks|Modified intention to treat (MITT) analysis set included all randomized participants who received at least 1 dose of study treatment, no major protocol violations, and no baseline primary NNRTI resistance mutation (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])|||Percentage of participants|||Number
1291842|NCT00111917|Post-Hoc|BAL % Lymphocytes|% of WBCs that are lymphocytes in bronchoalveolar lavage|after 28 week infusion||||percentage of lymphocytes in BAL||Standard Deviation|Median
1291843|NCT00111917|Post-Hoc|BAL WBC/cc|WBC * 10^6/cc in bronchalveolar lavage|after 28 weeks||||absolute WBC*10^6/cc||Standard Deviation|Median
1291844|NCT00111917|Primary|A-a Gradient at End Exercise|change in end-exercise A-a gradient|after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen|Accurate measures were not obtained on all patients at both timepoints.|||mmHg||Standard Error|Median
1291845|NCT00111917|Post-Hoc|Absolute Numbers of Lymphocytes|Absolute number of lymphocytes*10^6/cc in blood|after 28 week follow-up||||absolute number*10^6/cc||Standard Error|Median
1291846|NCT00111839|Secondary|Change From Baseline to Cycle 2 in Global Quality of Life (QoL), as Assessed Using Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain] and 3 items were global items (symptom distress, interference with activity level, and global QoL). The global QoL item scores are reported here. The total global QoL item score ranged from 0 (worse QoL) to 100 (best QoL).|Baseline, Cycle 2 (Cycle length = 3 weeks)|ITT population. Here, overall number of participants analyzed = participants with available data for this outcome; number analyzed = participants with available data at specified timepoint.|||units on a scale||Standard Deviation|Mean
1291847|NCT00111839|Secondary|Duration of Objective Response Assessed by Independent Review Committee|Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (>25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.|From first documented objective response to PD or death due to any cause (up to approximately 3.5 years)|ITT population.|||months||95% Confidence Interval|Median
1291848|NCT00111839|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.|Baseline up to PD or death due to any cause (up to approximately 3.5 years)|ITT population.|||months||95% Confidence Interval|Median
1291849|NCT00111839|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.|Baseline up to PD or death due to any cause (up to approximately 3.5 years)|ITT population.|||months||95% Confidence Interval|Median
1291850|NCT00111839|Primary|Number of Participants With Objective Response Assessed by Independent Review Committee|Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. Complete response: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.|Baseline up to PD or death due to any cause (up to approximately 2 years)|ITT population.|||participants||95% Confidence Interval|Number
1291925|NCT00110812|Post-Hoc|Commencement of Continuous Antiretroviral Treatment|Number of patients commencing continuous antiretroviral treatment.|from randomization through February 28, 2011, the end of the extension phase|All randomized patients are counted. Patients who did not consent to the extension phase are censored at the end of the main study (Feb 28, 2009). Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.|||participants|||Number
1291851|NCT00111813|Secondary|Laboratory AE Summary|"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.~A lab (S)AE was any lab value considered clinically significant in the investigator's judgment."|Day 1 up to disease progression, toxicity, or death, assessed up to 29 months||||Participants|||Number
1291852|NCT00111813|Secondary|Clinical AE Summary|"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.~A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose."|Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)||||Participants|||Number
1291853|NCT00111813|Secondary|Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.|Day 1 to disease progression, toxicity, or death, assessed up to 29 months||||Days||Standard Deviation|Mean
1291854|NCT00111813|Secondary|Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug|An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.|Day 1 to disease progression, toxicity, or death, assessed up to 29 months||||Participants|||Number
1291855|NCT00111813|Primary|Mean Duration of Treatment With Vorinostat|"Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity.~Progressive disease was defined as:~>25% increase in the level of serum monoclonal paraprotein.~25% increase in 24-hour urinary light chain excretion.~>25% increase in plasma cells in a bone marrow aspirate or on trephine~biopsy.~Development of new bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia.~Intolerable toxicity was based on the clinical judgment of the investigator."|Day 1 to an event causing discontinuation from the study, assessed up to 29 months||||Days||Full Range|Mean
1291856|NCT00111800|Secondary|Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK|A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DPP-IV inhibition. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.|Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20|PPK Population. The data for this outcome measure was not collected.||||||
1291857|NCT00111800|Secondary|Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN|A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DEN plasma concentrations. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.|Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20|Sparse PK (PPK) Population comprised of all those participants who were assigned to the sparse (population PK) group. All consenting participants were eligible for inclusion in the sparse PK population except for those participants participating in the serial PK assessment. The data for this outcome measure was not collected.||||||
1291858|NCT00111800|Secondary|Number of Participants With Urinalysis Microscopic Result|The parameters of microscopic urinalysis included RBC and WBC. The microscopic urinalysis results for the parameters were categorized as cells of 0-1, 1-3, 3-5, 5-10, 10-15, 15-25, 25-50, 50-100 and innumerable. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).|Up to Follow-up (Week 25)|Safety Population.|||Participants|||Count of Participants
1291859|NCT00111800|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Result|The parameters of dipstick urinalysis included glucose, bilirubin, protein and ketones. The abnormal results of dispstick parameters were categorized for glucose as trace or 1/10 gram (g)/deciliter (dL %), 1+ or ¼ g/dL (%), 2+ or ½ g/dL (%), 3+ or 1 g/dL (%); for ketones as 1+ and trace; for proteins as 1+, 2+, 3+ and trace. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).|Up to Follow-up (Week 25)|Safety Population.|||Participants|||Count of Participants
1291860|NCT00111800|Secondary|Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy|The parameters of hematology included red blood cell (RBC) count, hemoglobin, hematocrit, platelet count and total white blood cell (WBC) count. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.|Up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1297093|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 2||Baseline to Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1291861|NCT00111800|Secondary|Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy|The parameters of clinical chemistry included sodium, potassium, chloride, bicarbonate, lactate dehydrogenase ([LDH] if >2x upper limit of reference range, LDH isoenzymes were collected), total protein, albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), Calcium, phosphorus (inorganic) and uric acid. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.|Up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1291862|NCT00111800|Secondary|Change From Baseline in 12-lead ECG Over Time|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, RR, QT, and QTc intervals. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett’s formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. ECG was read centrally and locally at Visit 2 (Week -5), Visit 5 (Week 0), Visit 9 (Week 4), Visit 12 (Week 12), Visit 16 (Week 16) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
1291863|NCT00111800|Secondary|Mean Change From Baseline in Waist to Hip Ratio Over Time|Waist to hip ratio calculation from the waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1291864|NCT00111800|Secondary|Change From Baseline in Waist Circumference and Hip Circumference Over Time|Waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Centimeter (cm)||Standard Deviation|Mean
1291865|NCT00111800|Secondary|Change From Baseline in Body Mass Index (BMI) Over Time|BMI is an estimated the body fat of the participants, based on body weight divided by height squared. Height was assessed at Screening (Visit 2, Week -5) and confirmed at Baseline (Visit 5, Week 0). Weight was assessed at all Visits (Visit -5 to Visit 19). BMI was calculated during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) and Week -5 to 25 (Follow-up)|Safety Population. Only those participants available at the specified time points were analyzed.|||kg/meter square (m^2)||Standard Deviation|Mean
1291866|NCT00111800|Secondary|Change From Baseline in Body Weight Over Time|The assessment of body weight was done during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) and Week -5 to 25 (Follow-up)|Safety Population. Only those participants available at the specified time points were analyzed.|||Kilogram (kg)||Standard Deviation|Mean
1291867|NCT00111800|Secondary|Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy|The vital sign assessments include systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The assessments were done pre-dose at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1 to 24) values. The criteria for PCC included: HR increase or decrease from Baseline >30 beats per minute (bpm) and <50 or >120 bpm; SBP increase or decrease from Baseline >30 millimeter of mercury (mmHg) in the same posture and >170 or <100 mmHg; increase or decrease from Baseline >20 mmHg in same posture and >110 or <50 mmHg.|Baseline (Week 0) up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1291868|NCT00111800|Secondary|Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. The assessment of severity was done by the investigator. A mild AE was defined as an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. A moderate AE was defined as an event that was sufficiently discomforting to interfere with normal everyday activities. A severe AE was defined as an event that prevents normal everyday activities.|Up to Week 25|Safety Population.|||Participants|||Count of Participants
1291869|NCT00111800|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia.|Up to Week 25|Safety population was defined as all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1291870|NCT00111800|Secondary|Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8|The samples for pro-insulin and insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4 and 8) values. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 4 and 8|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1291871|NCT00111800|Secondary|Change From Baseline in Pro-insulin to Insulin Ratio at Week 12|The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Error|Least Squares Mean
1291872|NCT00111800|Secondary|Change From Baseline in Pro-insulin at Week 16, 20 and 24.|The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values.|Baseline (Week 0) up to Week 24|ITT Population without LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||pmol/L||Standard Deviation|Mean
1291873|NCT00111800|Secondary|Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8|The assessment of fasting serum insulin measures a participant’s serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.|Baseline (Week 0) up to Week 24|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||pmol/L||Standard Deviation|Mean
1291874|NCT00111800|Secondary|Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12|The assessment of fasting serum insulin measures a participant’s serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Picomole (pmol)/L||Standard Error|Least Squares Mean
1291875|NCT00111800|Secondary|Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24|The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.|Baseline (Week 0) up to Week 24|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||µmol/L||Standard Deviation|Mean
1291876|NCT00111800|Secondary|Change From Baseline in Fructosamine at Week 12|The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Micromole (µmol/L)||Standard Error|Least Squares Mean
1291877|NCT00111800|Secondary|Number of Participants of FPG Responders at Week 12|The glycemic assessment of FPG measures a participant’s blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of <7 mmol/L and FPG reduction value of >=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.|Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1292338|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1460 days||||percentage of partcipants|||Number
1291878|NCT00111800|Secondary|Number of Participants Who Were HbA1c Responders at Week 12|HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of <=6.5%, <7% and HbA1c reduction of >=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.|Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1291879|NCT00111800|Secondary|Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24|The glycemic assessment of FPG measures a participant’s blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24) values.|Baseline (Week 0) up to Week 24|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
1291880|NCT00111800|Secondary|Change From Baseline in FPG at Week 12|The glycemic assessment of FPG measures a participant’s blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Millimole per liter (mmol/L)||Standard Error|Least Squares Mean
1291881|NCT00111800|Secondary|Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24|HbA1c is use d to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, Week 8, Week 16, Week 20 and Week 24) values.|Baseline (Week 0) up to Week 24|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
1291882|NCT00111800|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean.|Baseline (Week 0) and Week 12|Intent-to Treat (ITT) Population was defined as all randomized participants who received at least one dose of randomized study medication, had a Baseline assessment and had at least one corresponding on-therapy (scheduled or unscheduled) efficacy assessment. Only those participants available at the specified time points were analyzed.|||Percentage of HbA1c||Standard Error|Least Squares Mean
1291883|NCT00111761|Secondary|Time to Initial Objective Tumor Response (Part 1)|Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subset of Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy, who had an objective tumor response.|||weeks||Inter-Quartile Range|Median
1291884|NCT00111761|Secondary|Time to Treatment Failure (Part 1)|Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||Weeks||95% Confidence Interval|Median
1291885|NCT00111761|Secondary|Survival Time (Part 1)|Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.|From enrollment until death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||weeks||95% Confidence Interval|Median
1291886|NCT00111761|Secondary|Time to Disease Progression (Part 1)|Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||weeks||95% Confidence Interval|Median
1291887|NCT00111761|Secondary|Progression-free Survival Time (Part 1)|Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||weeks||95% Confidence Interval|Median
1291888|NCT00111761|Secondary|Number of Participants With Objective Tumor Response (Part 1)|Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||Participants|||Number
1291889|NCT00111761|Secondary|Number of Participants Who Died (Part 2)|The number of participants in Part 2 who died during the study.|From enrollment until last contact. Maximum follow-up was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy|||participants|||Number
1291890|NCT00111761|Secondary|Survival Time (Part 2)|Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.|From enrollment until death. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||weeks||95% Confidence Interval|Median
1291891|NCT00111761|Secondary|Progression-free Survival Time (Part 2)|Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy|||weeks||95% Confidence Interval|Median
1291892|NCT00111761|Secondary|Time to Disease Progression (Part 2)|Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.|From enrollment until death or diease progression. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy|||weeks||95% Confidence Interval|Median
1291893|NCT00111761|Secondary|Number of Participants With an Objective Tumor Response (Part 2)|Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.|Until disease progression (median 47 weeks)|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy|||Participants|||Number
1291894|NCT00111761|Primary|Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)|The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||Participants|||Number
1291895|NCT00111761|Primary|Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)|The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).|Until disease progression (median 47 weeks)|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy.|||Participants|||Number
1291896|NCT00111657|Secondary|Infusion 1: Minimum Concentration (Cmin)|The lowest drug concentration in the blood after the first infusion of study drug.|21 days after the infusion|One subject withdrew prior to completing the first infusion and is not included in this analysis.|||mU/mL||Standard Deviation|Mean
1291897|NCT00111657|Secondary|Infusion 1: Maximum Concentration (Cmax) Value|The highest drug concentration in the blood after the first infusion of study drug.|2 hours|One subject withdrew prior to completing the first infusion and is not included in this analysis.|||mU/mL||Standard Deviation|Mean
1291898|NCT00111657|Secondary|Development of Antibodies to PEG-uricase|Number of patients who developed antibodies to PEG-uricase|baseline, then prior to infusions and 7 wks after last infusion|One subject withdrew prior to completing the first infusion and is not included in this analysis.|||participants|||Number
1291899|NCT00111657|Secondary|Reduction of the Ratio of Uric Acid:Creatinine in Urine||baseline then weekly|These data were not calculated because the effect size of serum irate reduction in plasma was so robust that there was no utility in this assessment.||||||
1291900|NCT00111657|Secondary|In a Subset of Subjects Who Volunteer Separately, Change in Uric Acid Pool Size Will be Assessed by a Method That Involves Infusion of Uric Acid Labeled With N15, a Stable (Nonradioactive) Isotope of Nitrogen.||baseline and 7 weeks after last infusion|Data was not collected for this outcome as a result of a separate pilot study demonstrating that the measure was not useful.||||||
1291901|NCT00111657|Secondary|Clinical Response: Number of Swollen and Tender Joints|Count of tenderness and swelling of 68 joints|Basline and day 134|30 subject assesed at baseline. 21 subjects who completed study were assesed at day 134|||joints||Inter-Quartile Range|Median
1291902|NCT00111657|Primary|Reduction in Plasma Uric Acid to Less Than 6 mg/dL.||Baseline to Day 105||||Participants|||Number
1291903|NCT00111241|Secondary|Knee Subchondral Bone Expansion|change in subchondral bone expansion area over two years|Baseline, Two years||||mm²||Standard Deviation|Mean
1291904|NCT00111241|Primary|Knee Cartilage Volume|change in medial and lateral articular tibial cartilage volume over two years|Baseline, two years||||mm³||Standard Deviation|Mean
1291926|NCT00110812|Post-Hoc|Undetectable HIV-RNA|Patients with undetectable HIV-RNA levels measured at 24 months after the close of the main study, at the end of the extension phase.|24 months post-trial|All patients for whom an HIV-RNA measurement was available during the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.|||participants|||Number
1291905|NCT00111007|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted|Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).|baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)|Change in ECOG PS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||participants|||Number
1291906|NCT00111007|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.|Time from initial response to documented tumor progression or death (median time of 197 days)|DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||days||Full Range|Median
1291907|NCT00111007|Secondary|Time to Progression (TTP)|TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (DP) (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.|Time from randomization to documented tumor progression (median time of 126 days)|TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||days||95% Confidence Interval|Median
1291908|NCT00111007|Secondary|Overall Survival (OS)|Overall survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.|Time from randomization to death (median time of 294 days)|OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||days||95% Confidence Interval|Median
1291909|NCT00111007|Primary|Progression Free Survival (PFS)|PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.|Time from randomization to documented tumor progression or death (median time of 124 days)|PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||days||95% Confidence Interval|Median
1291910|NCT00110994|Secondary|Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment|European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents’ self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||scores on a scale||Standard Deviation|Mean
1291911|NCT00110994|Secondary|Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted|European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||scores on a scale||Standard Deviation|Mean
1291912|NCT00110994|Secondary|Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment|European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ‑5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||scores on a scale||Standard Deviation|Mean
1291927|NCT00110812|Post-Hoc|CD4+ Cell Count 2 Years Post-study||two years following close of main study|All patients for whom a CD4 count measurement was available during the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.|||cell/mm^3||Standard Deviation|Mean
1291913|NCT00110994|Secondary|Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted|European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ‑5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||scores on a scale||Standard Deviation|Mean
1291914|NCT00110994|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted|Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change in ECOG performance status was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||participants|||Number
1291915|NCT00110994|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.|Time from initial response to documented tumor progression or death (median time of 188 days)|DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||days||95% Confidence Interval|Median
1291916|NCT00110994|Secondary|Time to Progression (TTP)|TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.|Time from randomization to documented tumor progression (median time of 148 days)|TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||days||95% Confidence Interval|Median
1291917|NCT00110994|Secondary|Number of Participants in Tumor Response Categories|Tumor response was defined as the best response (confirmed complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]) assessed using the Response Evaluation Criteria in Solid Tumors (RECIST). PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD. CR: Disappearance of all target lesions. SD: Does not qualify for CR or PR. PD: at least a 20% increase in SLD taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions.|Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Tumor response was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||participants|||Number
1291918|NCT00110994|Secondary|Overall Survival (OS)|Overall Survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.|Time from randomization to death (the maximum treatment duration of 71.1 weeks)|OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||days||95% Confidence Interval|Median
1291919|NCT00110994|Primary|Progression Free Survival (PFS)|PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.|Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)|PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||days||95% Confidence Interval|Median
1291920|NCT00110890|Secondary|Number of Participants With Mean Serum P < 5.5 mg/dL|Number of participants with mean serum phosphorus (P) < 5.5 mg/dL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
1291921|NCT00110890|Secondary|Number of Participants With Mean Serum Ca < 9.5 mg/dL|Number of participants with mean serum calcium (Ca) < 9.5 mg/dL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17-23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
1291922|NCT00110890|Secondary|Number of Participants With Mean Ca x P < 55 mg^2/dL^2|Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
1291923|NCT00110890|Secondary|Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL|Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase|Efficacy Assesment Phase (weeks 17-23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
1291928|NCT00110812|Post-Hoc|Opportunistic Disease or Death During the Trial Extension Phase|Incidence of an opportunistic event (AIDS-defining infection or malignancy) or death between February 28, 2009, when the main study ended, and February 28, 2011, when the extended phase was completed.|two years following close of main study|All patients who were alive at the end of the main study and who consented to be followed for an additional 2 years in the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.|||participants|||Number
1291929|NCT00110812|Secondary|SGOT|Number of participants with aspartate aminotransferase (SGOT) greater than 5 times the upper limit of normal|week 32|all patients with SGOT measured at week 32|||participants|||Number
1291930|NCT00110812|Secondary|Thyroid Stimulating Hormone|Number of participants with thyroid stimulating hormone greater than the upper limit of normal|week 32|all patients with TSH measured at 32 weeks|||participants|||Number
1291931|NCT00110812|Secondary|Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12||month 12|patients for whom HIV-RNA measurement was available at baseline and month 12.|||copies/ml (log 10)||Standard Deviation|Mean
1291932|NCT00110812|Secondary|Initiation of Continuous ART|While patients were not taking ART at baseline or while undergoing IL-2 cycles (other than use of pericycle ART in one of the three groups), some chose to start an ART regimen during the study.|from randomization through February 28, 2009|all patients randomized|||participants|||Number
1291933|NCT00110812|Secondary|Disease Progression or Death|occurrence of an opportunistic event (AIDS-defining infection or malignancy) or death|throughout study, through Feb 28 2009 (median followup of 19 months)|all randomized patients|||participants|||Number
1291934|NCT00110812|Secondary|Fasting Lipid Profile|total fasting cholesterol|week 32|all patients with laboratory data at week 32 who reported fasting|||mg/dl||Standard Deviation|Mean
1291935|NCT00110812|Secondary|HIV-1 Genotype Changes|Patients who developed mutations associated with antiretroviral drugs.|after 3rd cycle of IL-2|Per protocol, the analysis of genotypic changes associated with antiretroviral resistance was restricted patients in one arm, namely, patients assigned to take pericycle HAART who completed 3 cycles of IL-2 and who had successful genotypes.|||participants|||Number
1291936|NCT00110812|Secondary|Change in CD4 T Lymphocyte Count|change from baseline to month 12 in CD4 T lymphocyte count|At Month 12|patients for whom the month 12 CD4 count was available|||cell/mm^3||Standard Deviation|Mean
1291937|NCT00110812|Secondary|Plasma HIV RNA|change from baseline in HIV-RNA copies/ml (log10)|At Week 32|Patients for whom HIV-RNA was available at week 32|||copies/ml (log 10)||Standard Deviation|Mean
1291938|NCT00110812|Secondary|Discontinuation of IL-2|Patients receiving fewer than 3 cycles of IL-2 by week 32|week 32|all patients randomized to a study arm containing IL-2|||participants|||Number
1291939|NCT00110812|Primary|Mean Change in CD4+ T Lymphocyte Count|Change in CD4 count from baseline to week 32.|Week 32|patients for whom the week-32 CD4+ cell count was measured|||cell/mm^3||Standard Deviation|Mean
1291940|NCT00110617|Secondary|Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 104|Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 104 for the Deferasirox treatment group. Means were adjusted for the amount of transfused blood.|Start of Deferasirox (ICL670) treatment, 104 Weeks|Per Protocol- 2 set defined as all participants who received study drug and had assessment of serum ferritin at Start of ICL670 treatment and at 104 weeks.|||mg/mL||95% Confidence Interval|Least Squares Mean
1291941|NCT00110617|Primary|The Number of Participants With Adverse Events (AEs) in the First 24 Weeks of Treatment|The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks.|24 Weeks|Safety-1 set: All participants, except participants enrolled in Center 512, who received at least one dose of study medication during the first 24 weeks.|||participants|||Number
1291942|NCT00110617|Secondary|Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 24 and to Week 52|Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 24 and the absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 52 for the Deferasirox treatment group and the Deferoxamine then Deferasirox treatment group. Means were adjusted for the amount of transfused blood.|Start of Deferasirox (ICL670) treatment, 24 Weeks, 52 Weeks|Per Protocol- 2 set defined as all participants who received study drug and had an assessment of serum ferritin at Start of ICL670 treatment and at 24 weeks or 52 weeks.|||mg/mL||95% Confidence Interval|Least Squares Mean
1291943|NCT00110617|Secondary|Absolute Change in Serum Ferritin From Baseline to Week 24|Absolute change from baseline serum ferritin after 24 weeks of treatment with Deferasirox (ICL670) and absolute change from baseline serum ferritin after 24 weeks of treatment with Deferoxamine. Means were adjusted for the amount of transfused blood.|Baseline, 24 Weeks|Per protocol- 1 defined as all participants who had study drug and had an assessment of serum ferritin at Baseline and at Week 24.|||mg/mL||95% Confidence Interval|Least Squares Mean
1291944|NCT00110513|Primary|Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT)|To assess the incidence of thromboembolic events acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute deep venous thrombosis (DVT) by clinical signs and symptoms of venous thromboembolism (VTE), confirmed by diagnostic assessments.|During treatment and follow up period of 7 days|Intent to treat population|||Participants|||Number
1291945|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30|"Change from previous phase to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291946|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4|"Change from previous phase to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291947|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30|"Change from previous phase to Week 30 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous week, only randomized subjects who had both previous week and at least next week were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291948|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4|"Change from previous phase to Week 4 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291949|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30|"Change from previous phase to Week 30 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291950|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4|"Change from previous phase to Week 4 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291951|NCT00110461|Secondary|Subject Response to Treatment at Week 30|"Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 30|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.|||percentage of participants|||Number
1291952|NCT00110461|Secondary|Subject Response to Treatment at Week 4|"Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 4|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.|||percentage of participants|||Number
1291990|NCT00110357|Secondary|Maximum Plasma Concentration (Cmax)|The single dose pharmacokinetics (PK) of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; Cmax was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||µg/mL||Standard Deviation|Geometric Mean
1292339|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1095 days||||percentage of partcipants|||Number
1291953|NCT00110461|Secondary|Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30|"Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291954|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30|Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291955|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4|Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291956|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30|Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291957|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4|Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291958|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30|Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291959|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4|Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1292340|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 730 days||||percentage of partcipants|||Number
1291960|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30|Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291961|NCT00110461|Secondary|Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30|Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291962|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30|"Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291963|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4|"Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291964|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30|"Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291965|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4|"Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291966|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30|"Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291991|NCT00110357|Secondary|Number of Participants With a Dose-Limiting Toxicity|Dose-limiting toxicities (DLTs)=serious drug side effects preventing further dose escalation. If 1 of the first 3 subjects developed a DLT during cycle 1 up to 3 additional subjects were enrolled at that dose level. The maximum dose level at which DLTs occurred in fewer than 2 out of 3 to 6 subjects was defined as the Maximum Tolerated Dose (MTD).|Prior to each 21-day cycle until dose-limiting toxicities|All treated subjects|||Participants|||Number
1298956|NCT00006409|Primary|MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)||Post-2 year intervention||||Minutes of MET-weighted MVPA˙||Standard Error|Mean
1291967|NCT00110461|Secondary|Change in Children's Global Assessment (CGAS) Total Score at Week 30|"Change from baseline to Week 30 in CGAS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291968|NCT00110461|Secondary|Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4|Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291969|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4|Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291970|NCT00110461|Secondary|Change in Children’s Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4|Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291971|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4|"Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291972|NCT00110461|Secondary|Change in Children’s Global Assessment Scale (CGAS) Total Score at Week 4|"Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291973|NCT00110461|Secondary|Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30|"Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 30|Since the endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1292001|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis|The analysis is based on the last observed viral load data within the Week 240 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Participants|||Number
1291974|NCT00110461|Primary|Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4|"Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.)~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 4|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects be different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
1291975|NCT00110396|Secondary|Number of Participants With Binding Antibodies (BAb) at Week 96|Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).|96 weeks|ITT (One participant did not have any post-baseline NAb assessments) LOCF imputation|||Participants|||Number
1291976|NCT00110396|Secondary|Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study|The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.|96 weeks|ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation|||participants|||Number
1291977|NCT00110396|Primary|Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.|The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.|96 weeks|ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation|||participants|||Number
1291978|NCT00110357|Secondary|Grade 3/4 Laboratory Abnormalities - Hypomagnesemia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment||||Participants|||Number
1291979|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Thrombocytopenia|Blood samples collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment||||Participants|||Number
1291980|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Neutropenia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe and undesirable AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment||||Participants|||Number
1291981|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Leukopenia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment||||Participants|||Number
1291982|NCT00110357|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan|MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)|Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.|As-treated population|||mg/m2|||Number
1291983|NCT00110357|Secondary|Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)|Toxicity assessments performed at least weekly from the 1st dose of study drug until at least 30 days after the final dose of study drug and thereafter every 4 weeks until all study-related toxicities resolved, returned to baseline, or were deemed irreversible, whichever was longer. Grade 3=severe AE; grade 4=disabling or life threatening.|Weekly throughout the study and every 4 weeks thereafter|All treated patients|||Participants|||Number
1291984|NCT00110357|Secondary|Human Anti-cetuximab Antibody (HACA) Response|In order to be considered positive for anti-cetuximab a sample had to: 1) be evaluable (i.e., have a pre and at least one post-treatment timepoint), 2) have an anti-cetuximab value > 7 ng/mL and 3) have a post-treatment sample at least twice the pre-treatment level.|Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle|Cohort comprises all enrolled participants who were tested for HACA. Evaluable participants had normal baseline HACA (≤ 7 ng/dL) and ≥1 postbaseline HACA levels; unevaluable participants either did not have enough sample for analysis or did not have a pre- and postinfusion sample for immunogenicity.|||Participants|||Number
1291985|NCT00110357|Secondary|Tumor Response|"Non-central nervous system (CNS) tumors evaluated using Response Evaluation Criteria In Solid Tumors (RECIST), criteria to define when cancer patients improve (respond), stay the same (stable), or worsen (progression). CNS tumors evaluated based on measurements by investigator, dependence on corticosteroids, and neurologic exam."|Every other 21-day cycle|All treated subjects|||Participants|||Number
1291986|NCT00110357|Secondary|Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; VSS/BSA was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||L/m2||Standard Deviation|Mean
1291987|NCT00110357|Secondary|Clearance Corrected for Body Surface Area (CL/BSA)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; CL/BSA was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||L/h/m2||Standard Deviation|Mean
1291988|NCT00110357|Secondary|Terminal Half-Life (T-Half)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; T-half was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||hours||Standard Deviation|Mean
1291989|NCT00110357|Secondary|Area Under the Curve, Extrapolated to Infinity (AUC[INF])|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; AUC(INF) was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||µg•h/mL||Standard Deviation|Geometric Mean
1291992|NCT00110305|Secondary|Number of Participants With Virologic Response (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm, by Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) Quartiles|Quartile 1, 2, 3 and 4 of AUC24h means the quartile with the lowest 25%, 26-50%, 51-75% and the highest 25% of AUC24h values, respectively, irrespective of the different doses of TMC278. For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96. Virologic response was calculated by time to loss of virologic response (TLOVR) algorithm.|Up to Week 96|Analysis included participants who received TMC278 with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter. Participants who discontinued treatment for reasons other than virological failure were excluded from this analysis.|||Participants|||Number
1291993|NCT00110305|Secondary|Trough Plasma Concentration (Ctrough) for TMC278|For each participant, a single value for trough (i.e. predose) plasma concentration (Ctrough) of TMC278 was estimated from a population pharmacokinetic model, based on samples collected throughout the trial up to Week 96.|Up to Week 96|Analysis included participants with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter.|||ng/mL||Standard Deviation|Mean
1291994|NCT00110305|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) for TMC278|For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96.|Up to Week 96|Analysis included participants with sufficient number of pharmacokinetic samples in order to derive population pharmacokinetic parameter.|||ng*h/mL||Standard Deviation|Mean
1291995|NCT00110305|Secondary|Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as a viral load greater than 0.5 log10 copies /mL above the nadir with a minimum of 500 copies/mL. For this study, treatment-emergent mutations (for at least one treatment) are presented as Resistance associated mutation (RAMs): i) Non-nucleotide reverse transcriptase inhibitor (NNRTI) RAMs, ii) Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Participants|||Number
1291996|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Relative) at Week 240|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of week 0) to Week 240|ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Percentage of CD4+ cells||Standard Deviation|Mean
1291997|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Absolute) at Week 240|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 240|ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Cells per microliter||Standard Deviation|Mean
1291998|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Relative) at Week 96|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 96|Intent to treat (ITT) population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count.|||Percentage of CD4+ Cells||Standard Deviation|Mean
1291999|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Absolute) at Week 96|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count.|||Cells per microliter||Standard Deviation|Mean
1292000|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 400 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Participants|||Number
1292015|NCT00110136|Secondary|Estimation of Toxicities While on St. John's Wort|Toxicities are quantified using the standard NCI toxicity criteria. The outcome is the percentage of participants who experience one or more toxicities. More detailed information on toxicities is found in the adverse events section.|Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)|All registered participants|||percentage of participants||95% Confidence Interval|Number
1292002|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Participants|||Number
1292003|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis|The analysis is based on the last observed viral load data within the Week 96 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response.|Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.|||Participants|||Number
1292004|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.|||Participants|||Number
1292005|NCT00110305|Primary|Number of Participants With Virologic Response at Week 48 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 48|Intent to treat population: Participants who received at least 1 dose of study medication.|||Participants|||Number
1292006|NCT00110214|Secondary|Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities|"The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death"|During treatment (up to 2 years)|Participants who did not received allocated intervention were excluded from toxicity analysis.|||percentage of participants|||Number
1292007|NCT00110214|Secondary|Progression-free Survival (PFS)|"PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
1292008|NCT00110214|Secondary|Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline|PSA decline will be reported on all patients and will be defined as a decrease in PSA value by >= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy.|Duration of study (up to 5 years)||||percentage of participants|||Number
1292009|NCT00110214|Primary|Overall Survival|Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
1292010|NCT00110149|Primary|EFS|Event = Death, second malignancy , disease progression.|1 year|The study was terminated early|||Participants|||Count of Participants
1292011|NCT00110149|Primary|Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks|"INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN’S LYMPHOMA~Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53."|14 weeks|The trial closed prematurely secondary to the company that produced the agent being sold to another company and the agent not being available to treat the full number of patients in this trial.|||Participants|||Count of Participants
1292012|NCT00110136|Secondary|Mood is Measured by the POMS Short Form.|"POMS stands for the Profile of Mood States This is a short version of the POMS (17 questions).~Each question is scored on a 0 to 4 scale. The POMS score is the sum of the responses to the 17 questions. Responses to some questions have been reversed to make higher responses better.~The range is 0 to 68.~Higher scores represent better overall mood."|Baseline and four weeks|All registered participants.|||units on a scale||Standard Deviation|Mean
1292013|NCT00110136|Secondary|Effect of St. John's Wort on Quality of Life (PCS)|"Quality of life was measured by the SF12 (MCS and PCS subscales). Now we'll summarize the PCS.~SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.~PCS is the physical health component of the SF-12. Normal population has a mean of 50 and a SD of 10. Higher scores reflect better physical health.~The range is 0 to 100.~Higher scores represent better mental health."|Baseline and four weeks|All registered participants.|||units on a scale||Standard Deviation|Mean
1292014|NCT00110136|Secondary|Effect of St. John's Wort on Quality of Life (MCS)|"Quality of life was measured by the SF12 (MCS and PCS subscales). First we'll summarize the MCS.~SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.~MCS is the mental health component of the SF-12. A normal population has a mean of 50 and a SD of 10. Higher numbers represent better mental health.~The range is 0 to 100.~Higher scores represent better mental health."|Baseline and four weeks|All registered participants.|||units on a scale||Standard Deviation|Mean
1292016|NCT00110136|Secondary|Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks|"The hot flash score is calculated as the frequency of hot flashes times the severity of the hot flashes averaged over a week.~Frequency is the number of hot flashes in a day. Severity is coded 0=None, 1=Mild, 2=Moderate, and 3=Severe. Score for each day is frequency times severity. Weekly score is averaged over seven days.~Score ranges from 0 to infinity~Lower scores are better."|Baseline and four weeks|All registered participants|||frequency times severity||Standard Deviation|Mean
1292017|NCT00110136|Primary|Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks|Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort|Baseline and four weeks|All registered participants|||number of occurrences||Standard Deviation|Mean
1292018|NCT00110084|Secondary|Adverse Event|Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Every 6 weeks||||participants|||Number
1292019|NCT00110084|Secondary|Overall Survival|Overall survival time was defined as the number of days from registration to the date of death or last follow-up|Death or last follow-up (up to 5 years)|Median survival time from Kaplan-meir estimate has not been attained.|||months||95% Confidence Interval|Median
1292020|NCT00110084|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.|Time from registration to progression or death (up to 5 years)||||months||95% Confidence Interval|Median
1292021|NCT00110084|Primary|Proportion of Patients With Confirmed Responses|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.~Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|Two consecutive evaluations at least 6 weeks apart|per protocol|||participants|||Number
1292022|NCT00110019|Secondary|Objective Response (Complete and Partial Response) Rate|Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters.|Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.|Intention-to-treat population, n=823|||proportion||95% Confidence Interval|Number
1292023|NCT00110019|Secondary|Progression-free Survival|Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.|Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry.|Intention-to-treat population, n=821, two patients had no information about date of progression, and were excluded from the analysis|||months||95% Confidence Interval|Median
1292024|NCT00110019|Primary|Overall Survival|Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.|Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.|Intention-to-treat population, n=823|||months||95% Confidence Interval|Median
1292025|NCT00109967|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Patients were followed for survival status for up to 5 years.||||months||95% Confidence Interval|Median
1292026|NCT00109967|Secondary|Toxicity|"As per the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician.~In this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event."|Assessed during treatment (up to 12, 28-day cycles)||||patients|||Number
1292027|NCT00109967|Secondary|Duration of Response|Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Response duration is followed up to 5 years from registration.|Of the 48 Rituximab Sensitive patients, 30 patients had a response. Of the 21 Rituximab Refractory patients, 11 patients had a response. Therefore, this endpoint uses 30 patients from the Rituximab Sensitive group and 11 patients from the Rituximab Refractory group in the analysis.|||months||95% Confidence Interval|Median
1292028|NCT00109967|Secondary|Time to Progression|Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Patients were followed up to five years after registration.||||months||95% Confidence Interval|Median
1292029|NCT00109967|Primary|Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria|"Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.~Partial Response (PR) requires a >=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses.~Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients.~We report the Overall Response Rate here."|Up to 12, 28-day cycles.||||percentage of patients||95% Confidence Interval|Number
1292341|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 365 days||||percentage of partcipants|||Number
1292030|NCT00109928|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 18 weeks of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1292031|NCT00109928|Secondary|Response Rate|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|up to 3 years or time of disease progression|All eligible patients who started protocol treatment were included in the analysis.|||participants|||Number
1292032|NCT00109928|Secondary|2-year Progression-free Survival Rate|Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.|0-2 years|All eligible patients who started protocol treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1292033|NCT00109928|Primary|2-year Overall Survival Rate|The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.|0-2 years|All eligible patients who started protocol treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1292034|NCT00109876|Secondary|Change in Pulmonary Function From Baseline at Month 24|Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.|Baseline and Month 24|All enrolled participants who met the eligibility criteria.|||Participants|||Count of Participants
1292035|NCT00109876|Secondary|Change in Pulmonary Function From Baseline at Month 3|Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.|Baseline and Month 3|All enrolled participants who met the eligibility criteria.|||Participants|||Count of Participants
1292036|NCT00109876|Secondary|Incidence of Adverse Events|The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event. > Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.|Up to 2 years|All enrolled participants who met the eligibility criteria.|||Participants|||Count of Participants
1292037|NCT00109876|Secondary|Number of Procedures Deemed Technical Successes|The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success. A technical success is defined as follows: The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g. impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success.|Up to 2 years|All enrolled participants who met the eligibility criteria.|||number of technical successes|||Number
1292038|NCT00109876|Secondary|Overall Time to Recurrence|The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.|Up to 2 years|All enrolled participants who met the eligibility criteria.|||years||95% Confidence Interval|Median
1292039|NCT00109876|Secondary|Overall Time to Local Failure|The overall time to local failure was defined as the time from registration to documentation of > local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.|Up to 2 years|All enrolled participants who met the eligibility criteria.|||years||95% Confidence Interval|Median
1292040|NCT00109876|Primary|Overall Survival at 2 Years|Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.|2 years from registration|All enrolled participants who met the eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1292041|NCT00109850|Secondary|Progression Free Survival|Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 5 years|All eligible patients who started treatment were included in the analysis.|||months||95% Confidence Interval|Median
1292042|NCT00109850|Secondary|Objective Response (Confirmed and Unconfined, Complete and Partial)|Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|at week 16, then every 3 months until progression|All eligible patients who started treatment and were evaluable for response were included in assessing response estimates.|||percentage of participants||95% Confidence Interval|Number
1292342|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)|Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 180 days||||percentage of partcipants|||Number
1292043|NCT00109850|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every two cycles of chemotherapy.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1292044|NCT00109850|Primary|Overall Survival at 2 Years|Measured from time of registration to date of death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1292045|NCT00109837|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assessed for adverse events after the induction cycle|Eligible patients who started therapy|||Participants with a given type of AE|||Number
1292046|NCT00109837|Primary|Continuous Complete Remission at 1 Year|A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.|After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year|Eligible, Ph-, treated, and evaluable patients|||participants|||Number
1292047|NCT00109772|Secondary|Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period|"Counts of study participants who had adverse events (AEs) while treated in either the Double-blind or Extension Periods. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 was used by the investigator to grade the severity of the AEs: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.~AEs are also summarized by whether they were serious, related to treatment and whether the AE caused treatment to be altered.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above."|Day 1 up to week 158|Safety population|||participants|||Number
1292048|NCT00109772|Secondary|Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12|An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal sensory nerve conduct velocity.|Day 0, week 12|Intent to treat population. Fifty participants did not have week 12 values.|||meters/second||Standard Deviation|Mean
1292049|NCT00109772|Secondary|Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12|An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal motor nerve conduct velocity.|Day 0, week 12|Intent to treat population. Fifty participants did not have week 12 values.|||meters/second||Standard Deviation|Mean
1292050|NCT00109772|Secondary|Participants Who Had a Change to CRPS Pain Medication During the Treatment Period|Participants who had any change in CRPS medication during the double-blind treatment period (up to week 12) are summarized. Changes include additions, discontinuations or dosage change of CRPS medication(s).|Day 1 to week 12|Intent to treat population|||participants|||Number
1292051|NCT00109772|Secondary|Patient Global Impression of Change (PGIC) at Week 12|The Patient Global Impression of Change asks the question: Overall, how would you rate your CRPS condition since the start of study drug? Answers are represented on a seven-point scale with -3=much worst and +3=much better.|Week 12|Intent to treat. Forty-five participants had no week 12 values.|||units on a scale||Standard Deviation|Mean
1292052|NCT00109772|Secondary|Change From Baseline in the Profile of Mood States (POMS) at Week 12|Participants completed the Profile of Mood States questionnaire that asks participants to rate how each of 65 words reflected their mood in the past week on a 5-point scale with 0=not at all and 4=extremely for a total scale of 0-260. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Six participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
1292053|NCT00109772|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12|Participants completed the Brief Pain Inventory which asks twelve questions that are rated on an eleven-point scale in which 0=most positive outcome and 10=the most negative outcome for a total scale of 0-120. BPI contains questions that concern the level of pain over the last week and the level of pain right now, the extent to which pain interfered with sleep, normal activities, ability to work, relationships, walking etc. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
1292054|NCT00109772|Secondary|Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12|The investigator rated the degree of allodynia on both the CRPS-affected limb and the normal (or less-affected) limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the values for the CRPS affected-limb to the normal limb at week 12.|Week 12|Intent to treat population. Last observation carried forward. Fifteen participants were missing values.|||units on a scale||Standard Deviation|Mean
1292055|NCT00109772|Secondary|Change From Baseline in “Mechanically Evoked” (Allodynia) Numeric Rating Scale (NRS) Score at Week 12|The investigator rated the degree of allodynia on both the CRPS-affected limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the baseline values for the CRPS affected-limb to the values at week 12. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Sixteen participants had either no baseline or post-treatment values.|||units on a scale||Standard Deviation|Mean
1292343|NCT00106938|Secondary|Composite Morbidity Measure|A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.|0 to 30 Days Post-procedure|Intent-to-Treat (ITT) population|||participants|||Number
1292056|NCT00109772|Secondary|Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12|Participants rated twelve CRPS symptoms using a four-point rating scale in which 1=the most positive outcome and 4= the most negative outcome for a total scale of 12-48. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Thirty-three participants had either no baseline or post-treatment values.|||units on a scale||Standard Deviation|Mean
1292057|NCT00109772|Secondary|Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12|Participants rated how the activity level on a given day compares with their activity level prior to the start of treatment. A seven-point scale is used with -3=much worse and +3=much better. Positive change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
1292058|NCT00109772|Secondary|Change From Baseline in Daily Sleep Assessment Average Score at Week 12|Participants rated how much CRPS pain interfered with their sleep each day in a diary. The Sleep Assessment uses an eleven point scale for four questions. Questions concern ability to fall asleep, ability to stay asleep, how refreshed the participant feels upon waking and how alert the participant is during the day. All use a scale of 0-10, where the higher number is the positive response (e.g. 0=Pain completely interferes with sleep and 10=Pain does not interfere). The mean of all four responses was calculated if at least 3 of the 4 questions had a value. Week 12 values are compared to baseline values. Positive change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
1292059|NCT00109772|Secondary|Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The evening pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
1292060|NCT00109772|Secondary|Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The morning pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
1292061|NCT00109772|Secondary|Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. Morning and evening scores are averaged. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
1292062|NCT00109772|Secondary|Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12|Short Form McGill Pain Questionnaire (SF-MPQ) is comprised of 15 pain qualities that are rated by the participant on a 4 point scale with 0=none and 3=severe. The scale for the Total Score is 0-45. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
1292063|NCT00109772|Primary|Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders.|Day 0, Week 12|Intent to treat|||percentage of participants|||Number
1292064|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Trunk to Limb Fat Ratio||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
1292065|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Limb Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
1292066|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Total Body Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
1292067|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Lean Body Mass||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
1292068|NCT00109733|Primary|Percent Change From Baseline to Week 24 in Trunk Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
1292069|NCT00109590|Primary|Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.|||ug/mL||Full Range|Median
1292383|NCT00106639|Secondary|Number of Participants With Efficacy Failure|Efficacy failure was the first occurrence of BPAR, graft loss or participant's death.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292070|NCT00109590|Primary|Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.|||ug/mL||Full Range|Median
1292071|NCT00109590|Primary|Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.|||ug/mL||Full Range|Median
1292072|NCT00109590|Secondary|Median Viral Load (log10 Copies/ml) at 24 Weeks Postpartum in Women||at 24 weeks postpartum|The number of particpants included in this analyses were for those for whom viral loads were available at 24 weeeks postpartum.|||participants||Full Range|Median
1292073|NCT00109590|Secondary|Resistance Mutations in HIV Infected Infants|Resistance mutations as identified by consensus sequencing or OLA|24 weeks postpartum|Amongst the infants who became HIV-infected.|||participants|||Number
1292074|NCT00109590|Secondary|Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.|Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation.|within 72 weeks postpartum|amongst the participants who developed resistance within 8 weeks postpartum|||participants|||Number
1292075|NCT00109590|Secondary|Number of Women With Grade >=3 Events After Start of Study Treatment|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included.|After start of study Treatment (postpartum)|All women who started treatment were included in an intention-to-treat analysis.|||participants|||Number
1292076|NCT00109590|Secondary|The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.||At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).|All women who started treatment were included in an intention-to-treat analysis|||percent of participants|||Number
1292077|NCT00109590|Secondary|The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry|The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.|at Day 10 or Week 6 postpartum.|Includes only the Subgroup of women with Plasma HIV RNA >= 500 copies/ml at Entry and who started treatment; analyzed using the intention-to-treat principle (according to assigned treatment, regardless of compliance with the protocol).|||percent of participants||95% Confidence Interval|Number
1292078|NCT00109590|Primary|Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.|||ug*hr/mL||Full Range|Median
1292079|NCT00109590|Primary|The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma|The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.|at Day 10 or Week 6 postpartum.|All women who started treatment were included in an intention-to-treat analysis (according to randomized treatment assignment, regardless of compliance with the protocol)|||percent of participants||95% Confidence Interval|Number
1292080|NCT00109590|Primary|The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).|The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.|within 8 weeks postpartum.|All women who started treatment were included in an intention-to-treat analysis.|||percent of participants||95% Confidence Interval|Number
1292081|NCT00109577|Secondary|Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)||Baseline to 8 weeks|||||||
1292082|NCT00109577|Secondary|Outcome Questionnaire --- a Self-report Questionnaire||Baseline to 8 weeks|||||||
1292083|NCT00109577|Secondary|Global Clinical Impressions||Baseline to 8 weeks|||||||
1292084|NCT00109577|Primary|Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale)|Change in mood from baseline to final visit, as evaluated by the Overall Bipolarity Index (composite of the Hamilton Depression Scale and the Young Mania Rating Scale); minimum possible score is 0 and maximum possible score is 103; higher scores mean worse symptomatology|Baseline to 8 weeks|All participants were included, since the analysis was intent-to-treat with last observation carried forward|||units on a scale||Standard Deviation|Mean
1292085|NCT00109473|Secondary|Fecal Calprotectin|Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease.|At 24 and 64 weeks||||micrograms per gram (microg/g)||95% Confidence Interval|Mean
1292086|NCT00109473|Secondary|Height Velocity|"Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height.~It is calculated by measuring height at two points of time and then dividing the change by the amount of time."|Baseline, week 12, 24 and 48||||cm/year||Standard Error|Mean
1292087|NCT00109473|Secondary|Crohn's Disease Endoscopic Index of Severity (CDEIS)|Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0–30. A higher score indicates more severe mucosal inflammation.|Baseline and 12 weeks||||Scores on a scale||95% Confidence Interval|Mean
1292088|NCT00109473|Secondary|Total Corticosteroid Use||12 weeks, 24 weeks|||||||
1292089|NCT00109473|Secondary|Pediatric Crohn's Disease Activity Index (PCDAI)|The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30.|Baseline, 12 and 24 weeks||||Scores on a scale||95% Confidence Interval|Mean
1292090|NCT00109473|Secondary|IMPACT III Score|Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life.|Baseline, 12 weeks, 24 weeks||||Scores on a scale||95% Confidence Interval|Mean
1292091|NCT00109473|Secondary|Serum IGF-1 (Insulin-like Growth Factor 1)z Score|"Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis.~The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean."|Baseline, 12 weeks, 24 weeks||||Z score||Standard Error|Mean
1292092|NCT00109473|Primary|Crohn's Disease Histologic Index of Severity (CDHIS)|The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16|Baseline and 12 weeks||||scores on a scale||95% Confidence Interval|Number
1292093|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 23F – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1292094|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 19F – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1292095|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 18C – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1292096|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 14 – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1292097|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 9V – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1292599|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 36|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1292098|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 6B – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1292099|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 4 – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1292100|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1292101|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1292102|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1292103|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1292104|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1292105|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1292106|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1292107|NCT00109343|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.|||Participants|||Number
1292108|NCT00109343|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
1292109|NCT00109343|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
1292110|NCT00109343|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
1292111|NCT00109031|Secondary|Number of Participants With WHO Grade 4 Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set|||participants|||Number
1292112|NCT00109031|Secondary|Duration of WHO Grade 2, 3 or 4 Oral Mucositis|"The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study.~OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible."|Up to Day 28|Primary analysis set with available OM assessment data|||days||Standard Deviation|Mean
1292113|NCT00109031|Secondary|Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set|||participants|||Number
1292114|NCT00109031|Secondary|Number of Participants With Parenteral or Transdermal Opioid Analgesic Use|Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.|Up to Day 28|Primary analysis set|||participants|||Number
1292115|NCT00109031|Secondary|Area Under the Curve (AUC) of Mouth and Throat Soreness Score|"The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS."|From the first day of study drug administration through Day 28|Primary analysis set with available MTS data|||MTS score * days||Standard Deviation|Mean
1292116|NCT00109031|Secondary|Duration of Severe Oral Mucositis (WHO Grade 3 and 4)|The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.|Up to Day 28|Primary analysis set|||days||Standard Deviation|Mean
1292117|NCT00109031|Primary|Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set|||participants|||Number
1292118|NCT00109005|Secondary|Evaluate Effects of Lenalidomide on Pathways|Tissue will be obtained to evaluate the effects of lenalidomide on pathways thought to be modulated by lenalidomide.|Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy.|This outcome measure was not analyzed because the investigator left the institution.||||||
1292119|NCT00109005|Secondary|Determine Dose Level With Superior Efficacy and Acceptable Toxicity|The most efficacious dose (with greater number of responses) with acceptable toxicity profile will be considered for use in subsequent trials. iI the number of responses is tied, then toxicity criteria (Common Terminology criteria (CTC) v3.0) will be used to select the preferred dose.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.||||||
1292120|NCT00109005|Secondary|Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 5 mg and 25 mg|Plasma samples will be obtained and plasma concentrations will be determined by a reversed-phase high-performance liquid chromatography (HPLC) assay using mass spectrometry (MS) detection.|Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours.|This outcome measure was not analyzed because the investigator left the institution.||||||
1292121|NCT00109005|Secondary|Overall Survival|Date of on-study to the date of death from any cause or last follow up.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.||||||
1292122|NCT00109005|Secondary|Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.||||||
1292123|NCT00109005|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|24 months||||Participants|||Number
1292124|NCT00109005|Primary|Clinical Responses in Patients With Metastatic Ocular Melanoma|Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|12 months|"Response data was combined for this outcome measure. Results are available for the combined cohorts only.~Sixteen out of seventeen patients were eligible for response assessments."|||Participants|||Number
1292125|NCT00108953|Secondary|Percentage of Participants for Whom Disease Control Was Achieved|Participants with disease control: those who have as best response complete response (CR), partial response (PR) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease) according to Response Evaluation Criteria in Solid Tumors (RECIST)|from date of randomization to end of treatment plus 30 days|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||Percentage of participants|||Number
1292126|NCT00108953|Secondary|Time to Response (TTR)|Time from date of randomization to date of first objective response (complete response [CR] or partial response [PR]) is documented and confirmed according to RECIST criteria|from date of randomization until 3 years later at end of study|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||days||Full Range|Median
1292127|NCT00108953|Secondary|Duration of Response|Time from date of first objective response (complete response [CR] or partial response [PR]) to date progression is first documented (as defined per independent central radiological assessment) or death, whichever occurs first|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||days||Full Range|Median
1292128|NCT00108953|Secondary|Time to Symptomatic Progression (TTSP)|Time from date of randomization to date of first documented symptomatic progression defined by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8) assessment|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||days||95% Confidence Interval|Median
1292129|NCT00108953|Secondary|Percentage of Participants in Each Category of Best Tumor Response|Percentage of participants with complete or partial response (CR or PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) and achieved during treatment or 30 days after end of treatment. CR: disappearance of all clinical and radiological tumor lesions. PR: at least 30% decrease in sum of the longest diameters of tumor lesions. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.|achieved during treatment or within 30 days after termination of active therapy|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||Percentage of participants|||Number
1292130|NCT00108953|Secondary|Progression Free Survival (PFS)|Time from the date of randomization to the date of the first documented radiological progression (as defined per independent central radiological assessment) or death, whichever occurs first|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||days||95% Confidence Interval|Median
1292131|NCT00108953|Secondary|Overall Survival|The time from date of randomization to date of death|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients. The table below gives the lower and upper limit of the confidence interval; 999999999 = not estimable.|||days||95% Confidence Interval|Median
1292132|NCT00108953|Primary|Time to Progression (TTP)|TTP was defined as the time from randomization to radiological disease progression by independent assessment.|from date of randomization of the first patient until 3 years later|The intent-to-treat (ITT) population, primary population for efficacy analysis, includes all randomized patients.|||days||95% Confidence Interval|Median
1292133|NCT00108862|Secondary|Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.|All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a HIV viral load at least 400 copies/mL were grouped separately those those who died or who had HIV viral loads below 400 copies/mL. Participants missing HIV viral loads at week 48 were coded as LFU in this analysis. Percents were calculated with associated standard errors.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292134|NCT00108862|Secondary|Percent of Participants With HIV IRIS.|All eligible participants were included in this analysis. The percent of participants with HIV-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292135|NCT00108862|Secondary|Percent of Participants With MTB IRIS.|All eligible participants were included in this analysis. The percent of participants with Mycobacteria tuberculosis (MTB)-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292136|NCT00108862|Secondary|Percent of Participants Whose CD4 Increased by at Least 100 Cells/mm^3 Between Baseline and Week 48.|All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a CD4 cell count increase of less than 100 cells/mm^3 were grouped separately those who died or whose CD4 cell count increased by at least 100 cells/mm^3. Participants missing CD4 cell counts at week 48 were coded as LFU in this analysis. The percents were calculated with associated standard errors.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292137|NCT00108862|Secondary|Percent of Participants With Confirmed or Probable Tuberculosis (TB) Whose TB Resolved, or Who Required TB Treatment Through the End of Follow-up, or Died, or Were Lost to Follow-up.|TB treatment outcome was assessed in the 800 eligible participants who had confirmed or probable TB at study entry. The sites determined if the TB was resolved. If TB was not resolved, TB treatment outcome status was determined based on whether TB treatment was ongoing at the last study visit; if the participant died while TB treatment was ongoing; or if the participant was lost to follow-up, withdrew consent, or other reason for lacking TB resolution status. Percents were calculated with associated standard errors.|Through week 48|Participants with confirmed or probable TB at study entry were included in this analysis. Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292139|NCT00108862|Secondary|Percent of Participants With Culture-confirmed Tuberculosis (TB) Who Survived Without AIDS Progression.|This analysis was based on 374 participants with culture-confirmed TB at entry. The percent with culture-confirmed TB surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292140|NCT00108862|Secondary|Time to First New AIDS-defining Illness or Death.|All eligible participants were included in this analysis. Weeks from randomization to first new AIDS-defining illness or death was analyzed using a stratified Cox proportional hazards regression model. The stratification was by screening CD4 cell count: <50 cells/mm3 versus =>50 cells/mm3.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||weeks||95% Confidence Interval|Number
1292141|NCT00108862|Secondary|Percent of Participants Reporting a Grade 3 or 4 Adverse Event or Laboratory Abnormality|All eligible participants were included in this analysis. The percent of participants whose highest reported grade of adverse events and laboratory abnormalities was Grade 3 or 4 was calculated with an associated standard error, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening/disabling, and Grade 5=death.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292142|NCT00108862|Other Pre-specified|Percent of Participants in the Greater Than or Equal to 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.|Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the =>50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292143|NCT00108862|Other Pre-specified|Percent of Participants in the Less Than 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.|Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the <50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292144|NCT00108862|Primary|Percent of Participants Who Survived Without AIDS Progression.|As this was a study of the strategy of providing antiretroviral therapy (ART) during the initial treatment of TB versus deferring ART until TB was treated for 8-12 weeks, all eligible participants randomized were followed for 48 weeks, whether they started ART as scheduled, whether they started ART at all, or even if the participant did not have TB and discontinued TB treatment. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
1292145|NCT00108732|Secondary|The Difference Between PSA Slopes Before and After Treatment|PSA slopes were assessed by multiple PSA values obtained prior to registration and during treatment. Only patients who completed at least 3 months of treatment were included in this analysis. The PSA slopes were calculated by a piecewise linear model using the three or four PSA values obtained prior to registration and PSA measurements obtained every 4 weeks for the first six months of treatment. Natural log transformed PSA levels were used in this analysis, and the difference between PSA slopes before and after treatment was calculated.|Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months|Only 31 patients who completed at least 3 months of treatment were included in this analysis.|||log PSA/month||Full Range|Median
1292146|NCT00108732|Secondary|Difference Between Day 4 PSA Level and Day 15 PSA Level|PSA level was assessed on Day 4 and Day 15 of cycle 1, and a comparison between the two measurements was done.|Assessed at day 4 and day 15 of cycle 1|Only 22 patients with both day 4 and day 15 PSA levels available were included in this analysis.|||ng/mL||Full Range|Median
1292147|NCT00108732|Secondary|Proportion of Patients With PSA Response|"PSA response is defined as complete biochemical response or partial response.~Complete Response:~A PSA < 0.2 ng/mL confirmed by a repeat PSA one month later is considered a complete biochemical response for patients with prior radical prostatectomy. A PSA < 1 ng/mL on three separate occasions taken at least one month apart is considered a complete biochemical response in patients with radiation therapy only.~Partial Response:~A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later."|Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months|Only eligible and treated patients in step I are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
1292148|NCT00108732|Primary|Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)|"For patients who achieved a > 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater.~Changes in PSA below 5 ng/mL will not be considered assessable for progression.~For patients whose PSA has not decreased by 50%, an increase in PSA value > 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL."|Assessed at 6 months|Only eligible and treated patients in step I are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
1292149|NCT00108628|Secondary|Clinician-Administered PTSD Scale (CAPS)|Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.|Baseline and 1 month post-treatment||||units on a scale||Standard Deviation|Mean
1292166|NCT00108433|Secondary|Percentage of Pathogens Eradicated|Eradication included Documented or Presumed Eradication of the given pathogen. Percentage of pathogen eradicated was calculated as number of pathogens eradicated divided by number of pathogens eradicated or persisted multiplied by 100.|STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||Percentage of Pathogens|||Number
1292150|NCT00108628|Secondary|SF-36 Mental Component|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
1292151|NCT00108628|Secondary|SF-36 Physical Component|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
1292152|NCT00108628|Secondary|Beck Depression Inventory|Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
1292153|NCT00108628|Secondary|PTSD Military Checklist|Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
1292154|NCT00108628|Secondary|Nightmare Effects Survey|This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
1292155|NCT00108628|Secondary|Pittsburgh Sleep Quality Index - Addendum|The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
1292156|NCT00108628|Primary|Pittsburgh Sleep Quality Index|Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
1292157|NCT00108628|Primary|Weekly Nights With a Nightmare||Baseline and 1, 3, and 6 months post-treatment||||nights/week||Standard Deviation|Mean
1292158|NCT00108628|Primary|Weekly Number of Nightmares||Baseline and 1, 3, and 6 months post-treatment||||weekly nightmares||Standard Deviation|Mean
1292159|NCT00108550|Secondary|Roland and Morris Disability Index Scores Adjusted for Time|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The single values reported below represent adjusted means of scores over all time points."|Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9|Randomized participants who received one dose of study drug|||units on a scale||95% Confidence Interval|Mean
1292160|NCT00108550|Primary|Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time|"Self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor word anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. Prior to analysis an order-preserving mean-matching variance-stabilizing transformation was applied to this measure placing it on a continuous 0-1.5 scale. The single values reported below represent adjusted means of transformed pain intensity over all time points."|Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9|Analysis of all randomized participants receiving study drug|||units on a scale||95% Confidence Interval|Mean
1292161|NCT00108524|Secondary|Change From Baseline in Blood Sugar at 48 Weeks|Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.|Baseline and 48 weeks||||mg/dL||95% Confidence Interval|Mean
1292162|NCT00108524|Secondary|Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks|Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.|baseline and 48 weeks||||mg/dL||95% Confidence Interval|Mean
1292163|NCT00108524|Primary|Change From Baseline in Body Weight at 48 Weeks|Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.|baseline and 48 weeks||||percentage of weight loss||95% Confidence Interval|Mean
1292164|NCT00108485|Primary|Change in Proteinuria||Baseline, 1 year|Nine participants were enrolled into this study, however baseline data is only available for 2 participants (1 from the Extended Release Niacin arm and 1 from the Placebo arm). Data was only analyzed for 2 participants.|||mg/dL|||Number
1292165|NCT00108433|Secondary|Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization|Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.|STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||Percentage of participants|||Number
1292167|NCT00108433|Secondary|Number of Participants With Complications During Therapy|Late metastatic sequelae associated with Gram positive bacterial infections: abdominal abscess, brain abscess, meningitis, septic arthritis, osteomyelitis, endocarditis, empyema, spinal epidural abscess, intracerebral epidural abscess, septic phlebitis and septic thrombophlebitis.|LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||participants|||Number
1292168|NCT00108433|Secondary|Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment|Ir assessment Cure: clinical signs/symptoms of infection (SSx) resolved and no reoccurrence; Improvement: Moderate resolution of SSx, no additional antibiotic needed; Failure: persistence/progression of baseline SSx, new clinical findings; Indeterminate: circumstances precluding above classification. Sp assessment Failure: concomitant antibiotic after day 3 up to/including Ir assessment day at TOC/upper limit of TOC window (if no Ir assessment at TOC), no Ir assessment at end of treatment (EOT) and TOC; Indeterminate: Sp assessment cured/ improved at EOT, no Ir assessment at TOC/indeterminate.|EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||participants|||Number
1292169|NCT00108433|Primary|Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.|Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||participants|||Number
1292170|NCT00108355|Secondary|Development of Post-paracentesis Circulatory Dysfunction (PCD)|Defined as an increase in Plasma Renin Activity (PRA) by >50% from baseline to a level > 4 ng/mL/h at post-paracentesis day|6 days after paracentesis|Plasma Renin Activity (lab value to measure PCD) was not available for 6 patients leaving 11 patients in Albumin (control group) and 8 patients in Vasoconstrictor (Treatment group) for this outcome analysis.|||participants|||Number
1292171|NCT00108355|Primary|Time to Recurrence of Ascites.|Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)|Variable depending on the patient, average 10 days||||days||Inter-Quartile Range|Median
1292172|NCT00108342|Primary|Quit Attempts, Use of NRTs, Preference Among NRTs|In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.|At testing, at follow-up|The study was terminated and the data were not analyzed due to the small sample size.||||||
1292173|NCT00108303|Primary|Log of the ODDS of Linkage|Log of the ODDS ratio of Linkage divided by the ODDS of no linkage from a maximum likelihood analysis conducted using the statistical program LINKAGE|1 day|Probands with schizophrenia, their relatives, and controls. The log of the odds ratio summarizes data from the entire study population.|||units on a log scale|||Number
1292174|NCT00108303|Primary|Heritability Coefficient|h squared which ranges from 0 to 1. This number is similar to the more standard Pearson's correlation coefficient, except that the variable, in this case P50 sensory gating, is correlated across the statuses: schizophrenia proband (has the illness), schizophrenia relative (not ill but relative of someone who is), or control (not ill and has no known ill relative, P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds.|5 years|Schizophrenia probands and relatives and controls.|||coefficient|Participants||Number
1292175|NCT00108303|Primary|Genetic Linkage|Log of the Odds for Linkage, a standard genetic analysis metric. The number shown as a result is from a polymorphism in the promoter of the gene for the alpha7 nicotinic receptor on chromosome. Its presence in the individuals in this study, considering all three groups in one analysis, is compared to what of P50 sensory gating. P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds. The log of the odds is the common logarithm of the ratio of the odds that the gene polymorphism and P50 sensory gating are associated versus the odds that they are both distributed in the individuals at random. It is similar to the more common chi squared.|ten years|People with schizophrenia and their relatives in families and controls as members of single families were used to establish the log of the odds ratio.|||log (odds ratio)|||Number
1292176|NCT00108277|Primary|Episodic Anxiety Scale|Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms).|1 month||||units on a scale||Standard Deviation|Mean
1292177|NCT00108160|Other Pre-specified|S. Aureus Re-infections (New or Recurrent)|The anatomic site of each S. infection at enrollment and S. aureus re-infection that occurred during the study was compared. S. aureus isolated from a different site of infection than at baseline was considered to represent a new infection. Isolation of S. aureus from the same site as the baseline infection was considered to represent a recurrent infection.|18 months||||participants|||Number
1292178|NCT00108160|Secondary|Acquisition of New S. Aureus Strains|In the Mupirocin Ointment (Treatment) and Polyethylene Glycol (Placebo) Arms, S. aureus isolates (MSSA or MRSA) that caused infection prior to enrollment in the study were compared with S. aureus infecting isolates (MSSA or MRSA) that occurred during the study (re-infections). Infecting isolates that were found to be MRSA at enrollment and MRSA during the study were considered to be the same strain; this same strain definition was also applied to MSSA isolates. Infecting isolates that changed from MRSA at enrollment to MSSA during the study (or vice versa) were considered to be different strains.|18 months|Participants with S. aureus re-infection who acquired a new strain during the 18 month study period.|||participants|||Number
1292600|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 24|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1292179|NCT00108160|Primary|Re-infection With S. Aureus|During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)|18 months|Re-infections with S. aureus, new or recurrent, were noted for all patients enrolled in the study and for patients who completed each study visit.|||participants with S. aureus re-infection|||Number
1292180|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12|Urinary ACR (micrograms per milligram) was determined at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (exponent (mean change on log scale) - 1. [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)|||percentage of change||95% Confidence Interval|Geometric Mean
1292181|NCT00108082|Secondary|Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12|Plasma lipid concentrations (milligrams per deciliter) were measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent(mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)|||percentage of change||95% Confidence Interval|Geometric Mean
1292182|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12|CRP concentration (milligrams per deciliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent (mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)|||percentage of change||95% Confidence Interval|Geometric Mean
1292183|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12|BNP concentration (picagram per milliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (mean change on log scale) -1) [Change is the Month 12 value (or value after 12 months of treatment) minus the Baseline value].|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)|||percentage of change||95% Confidence Interval|Geometric Mean
1292184|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12|Systolic and Diastolic BP were measured at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||mmHg (millimeters of mercury)||Standard Error|Mean
1292185|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12|LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||milliliters (mL)||Standard Error|Mean
1292186|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12|LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. The ejection fraction is the fraction of the blood volume available at the end of diastole that is pumped out of the ventricules during systole.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||milliliters (mL)||Standard Error|Mean
1292187|NCT00108082|Secondary|Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12|LV filling parameters, LV E-Volume and LV A-Volume, were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. These filling parameters represent the volumes of blood filling the ventricle during the passive filling phase (E-volume) and the active filling phase caused by atrial contraction (A-volume).|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||milliliters (mL)||Standard Error|Mean
1292188|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12|LV Mass was measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||grams||Standard Error|Mean
1292189|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12|LVMIH was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was available)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||g/m raised to 2.7 (g/(m^2.7))||Standard Error|Mean
1292190|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12|LVMI was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||grams per meters squared (g/m^2)||Standard Error|Mean
1292191|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12|LV Mass was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||grams (g)||Standard Error|Mean
1292192|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12|LVMIH was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. LV mass depends on body size. One method of determining whether an individual has LV hypertrophy relates LV mass to height raised to a power of 2.7.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||g/m raised to 2.7 (g/(m^2.7))||Standard Error|Mean
1292193|NCT00108082|Primary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12|LVMI was measured by MRI at Baseline and after 12 months of treatment/Month 12. A reduction in left ventricular mass, calculated as LVMI, of 5 g/m^2 was assumed to be clinically meaningful. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the Last Observation Carried Forward [LOCF] analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||grams per meters squared (g/m^2)||Standard Error|Mean
1292194|NCT00108069|Secondary|Adverse Event Grades|The combined serious and non-serious adverse event Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs for the GBM (Glioblastoma multiforme) and AG (Anaplastic glioma) cohorts.|7.5 years|Neither cohort completed planned accrual and are small in number separately. Additionally, the underlying histological grade would not affect toxicity. Therefore, these cohorts may be combined. The Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs.|||participants|||Number
1292195|NCT00108069|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|7.5 years||||Participants|||Number
1292196|NCT00108069|Primary|Response, Defined as Stable Disease or Objective (Partial or Complete) Response.|Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline.|Patients were followed for an average of six weeks for assessment of response|Two patients were not able to complete follow-up neuroimaging to assess response due to clinical progression of disease.|||Participants|||Number
1292197|NCT00107991|Secondary|Dermatology Life Quality Index Score (DLQI)|"The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.~Response rates were calculated as the percentage of participants achieving a response."|12 weeks||||Response Rate - % of participants||95% Confidence Interval|Number
1292198|NCT00107991|Secondary|Patient's Pain Score|Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Response rate was calculated as the percentage of patients classified as responders.|12 weeks||||Response Rate - % of participants||95% Confidence Interval|Number
1292199|NCT00107991|Secondary|Patient Global Assessment|"The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:~Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)"|12 weeks||||participants|||Number
1292200|NCT00107991|Primary|50% Reduction in Physician's Global Assessment Score (Percent of Participants)|"Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.~PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease."|12 weeks||||percentage of participants||95% Confidence Interval|Number
1292201|NCT00107991|Secondary|50% Reduction in Number of Lesions (Percent of Participants)|A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.|12 weeks||||percentage of participants||95% Confidence Interval|Number
1292202|NCT00107978|Primary|Clinical Response|The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.|7 to 14 days after the last antibiotic dose|Data for the all-treated population (AT) are presented. The AT and clinically evaluable (CE) populations were considered co-primary.|||patients|||Number
1292203|NCT00107952|Primary|Clinical Response|"Clinical Response: Categorical (Cured, Failed or Indeterminate)~Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to “lack of efficacy”; Death on or after Day 3 attributable to primary infection~Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.~Indeterminate: Inability to determine outcome"|7 - 14 days following end of antibiotic treatment||||participants|||Number
1292204|NCT00107900|Secondary|Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results|Intent to Treat (ITT) population|end of treatment|ITT population|||seconds||Standard Deviation|Mean
1292205|NCT00107900|Secondary|Change From Baseline for International Normalized Ratio (INR) Results|Intent to Treat (ITT) population|end of treatment|ITT population|||INR ratio||Standard Deviation|Mean
1292206|NCT00107900|Secondary|Change From Baseline for Prothrombin Time (PT) Results|Intent to Treat (ITT) population|end of treatment|ITT population|||seconds||Standard Deviation|Mean
1292207|NCT00107900|Primary|Prevention of Venous Thromboembolism (VTE)|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery).~Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography"|2 weeks|modified ITT population|||percentage of patients with event||90% Confidence Interval|Number
1292208|NCT00107783|Secondary|Change in 6 Minute Walk Test (6MWT)|Change from baseline of the 6MWT at 36 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.|||ft||Standard Deviation|Mean
1292209|NCT00107783|Secondary|Change in Timed Get up and go|Change from baseline of timed get up and go at 36 months. In timed get up and go, the patient is asked to stand up from a standard chair and walk a distance of 3 meters, turn around and walk back to the chair and sit down. The examiner measures the time it takes for the patient to perform this series of tasks.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.|||seconds||Standard Deviation|Mean
1292210|NCT00107783|Secondary|Change in Functional Reach Assessment|Change from baseline of functional reach assessment at 36 months. Functional reach assessment measures the difference between the length of a person's outstretched arm and their maximal reach forward, while maintaining balance.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.|||cm||Standard Deviation|Mean
1292211|NCT00107783|Secondary|Change in Schober's Test|Change from baseline of Schober's test at 36 months. Schober's test measures a patient's ability to flex his/her lower back. The examiner makes a mark at L5 (fifth lumbar vertebra) and places one finger 5 cm below and another finger 10 cm above this mark. The patient is asked to touch his/her toes. The examiner measures the increase in distance between the two fingers.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.|||cm||Standard Deviation|Mean
1292212|NCT00107783|Primary|Change in Total ROM Worse Hip.|Change from baseline in the total (external + internal) hip range of motion (ROM) in the worse hip at 36 months.|Measured at baseline and at 36 months|Intention to treat.|||degrees||Standard Deviation|Mean
1292213|NCT00107744|Secondary|Body Weight at 8 Weeks|Body weight was measured by trained staff using a standard protocol at week 8.|Baseline and 8 Weeks|All participants with body weight measures at each intervention phase|||kg||95% Confidence Interval|Mean
1292214|NCT00107744|Secondary|Change From Baseline in Serum LDL-cholesterol at 8 Weeks|Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method.|Baseline and 8 Weeks|All participants with lipid data|||mg/dL||95% Confidence Interval|Mean
1292223|NCT00107653|Secondary|Mean Change From Baseline in Fat Score at Week 72|Grading categories for the fat scale were as follows: 1 = <5% hepatocytes; 2 = 6 – 33% hepatocytes; 3 = 34 – 66% hepatocytes; 4 = 67 - 100% hepatocytes.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Score on a scale||Standard Error|Mean
1292215|NCT00107744|Primary|Change From Baseline in Average Systolic Blood Pressure at 8 Weeks|The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from 2 baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements.|Baseline and 8 Weeks|We conducted analysis according to intention-to-treat principle. All participants with data were included in analysis.|||mmHg||95% Confidence Interval|Mean
1292216|NCT00107653|Secondary|Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities|The table below includes participants with premature withdrawals due to adverse events or laboratory abnormalities.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.|||Participants|||Number
1292217|NCT00107653|Secondary|Number of Participants With Marked Abnormal Laboratory Parameters|The below table includes participants with marked abnormal lab parameters. Standard reference ranges include: Hematocrit: (fraction) 0.37 - 0.49, Hemoglobin 130 – 180 g/L, Platelets 150 – 350 10^9/L, White Blood Cell (WBC) 4.5 - 11.0 10^9/L, Lymphocytes 1.00 - 4.80 10^9/L, Neutrophils 1.80 - 7.70 10^9/L, Aspartate aminotransferase (AST) 0-40 U/L, ALT 0 – 55 U/L, Total bilirubin 0 – 17 μmol/L, Thyroxine T4 58 – 140 nmol/L, Thyroid Stimulating Hormone (TSH) 0.0 - 5.0 million units (mU)/L, Albumin 35.0 - 55.0 g/L, Chloride 100 – 108 mmol/L, Calcium 2.10 - 2.60 mmol/L, Phosphate 0.84 - 1.45 mmol/L, Uric acid 214 – 506 μmol/L.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment. 'n'=number of evaluable participants available at specified time point.|||Participants|||Number
1292218|NCT00107653|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An adverse event could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as adverse events. A serious adverse event (SAE) was any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.|||Participants|||Number
1292219|NCT00107653|Secondary|Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72|The 36-item Short Form Health Survey (SF-36) is a 36-item self-report questionnaire that includes 8 domain scales The 8 domains are incorporated into 2 components: mental and physical. The mental component (MC) includes social functioning, role limitations-emotional, mental health, and vitality. The physical component (PC) includes physical functioning, role limitations-physical, bodily pain, and general health perception. Raw domain scores are transformed to a 0 to 100 scale, [0=worst score (or quality of life) and 100=best score]. Two summary scale scores were computed based on weighted combinations of the 8 domain scores (Physical and the Mental Component) where no minimum or maximum score; higher score indicate better health status. The difference between study groups in change from baseline in SF-36 score at week 48 and 72 was analysed.|Baseline (Week 0), Week 48 and Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.|||Score on a scale||Standard Error|Mean
1292220|NCT00107653|Secondary|Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72|The Fatigue Severity Scale (FSS) is a 10-item self-report questionnaire designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 weeks by marking on a visual analogue scale (VAS) labelled at one end with “no fatigue” (‘0’ being the best) and at the other end with “greater fatigue” (‘100’ being the worst). Longer distance on the scale from “no fatigue” indicated “greater fatigue”. FSS values are presented based on questionnaire and visual analog scale. FSS values at week 48 and 72 are presented based on questionnaire and visual analog scale.|Baseline (Week 0), Week 48 and Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.|||Score on a scale||Standard Error|Mean
1292221|NCT00107653|Secondary|Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score|The Nonalcoholic Steatohepatitis (NASH) included an assessment of sinusoidal fibrosis, Mallory bodies, and hepatocyte ballooning (HB). Grading categories for the NASH scales were as: Sinusoidal fibrosis: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules, without diffuse interstitial sinusoidal collagen deposition; 3 = Involvement of most or all lobules;, with diffuse interstitial fibrosis involving some or most of the lobules Mallory bodies: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules; and Hepatocyte ballooning: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
1292222|NCT00107653|Secondary|Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72|Fat scores are categorised as Improved: > 1 category decrease in fat scale; stable: no change in fat scale; worsened: >= 1 category increase in fat scale.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
1292224|NCT00107653|Secondary|Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score|METAVIR fibrosis score is categorized as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: >= 1 category increase in activity score.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
1292225|NCT00107653|Secondary|Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score|METAVIR activity scale included activity defines as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: > = 1 category increase in activity score.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
1292226|NCT00107653|Secondary|Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72|METAVIR activity scores are categorised as histological activity (A) 0 = none; A1 = mild; A2 = moderate; A3 = severe where ‘0’ being ‘No activity’ and ‘3’ being ‘the sever activity’. Changes in liver inflammation defined as Improved: Participants whose METAVIR activity score at up to Month-72 decreases by 1 or more units compared to baseline; stable: Participants whose METAVIR activity score at up to Month-72 is the same as the baseline score; worsened: Participants whose METAVIR activity score at up to Month-72 increases by 1 or more units compared to baseline. METAVIR fibrosis scores are categorised as fibrosis (F) 0 = no fibrosis; F1 = without septa; F 2 = with septa; F3 = many septa; F4 = cirrhosis where; ‘0’ being the best and ‘4’ being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in activity and fibrosis scores based on METAVIR at week 72 was analysed.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Score on a scale||Standard Error|Mean
1292227|NCT00107653|Secondary|Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score|Overall ISHAK Fibrosis Score is defined as Improved: >= 1 category decrease in fibrosis scale; Stable: no change in fibrosis scale; Worsened: >1 category increase in fibrosis scale.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
1292228|NCT00107653|Secondary|Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72|ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) score at week 72. Baseline prognostic factors in the original model include ethnicity, sex, age, baseline ALT quotient, baseline HCV-RNA level, and ISHAK fibrosis and activity scores at baseline. ISHAK modified HAI fibrosis scale by fibrosis grading category as F0= no fibrosis; F1= some portal areas; F2= most portal areas; F3= bridging fibrosis; F4= bridging and portal to central; F5 = marked bridging; F6 = Cirrhosis; where ‘0’ being the best and ‘6’ being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was analysed.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.|||Score on a scale||Standard Error|Mean
1292229|NCT00107653|Secondary|Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72|ISHAK modified HAI activity (necroinflammatory) score is a total score of P/B necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each Participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5= zone 3 multiple; 6= panacinar necrosis and Focal necrosis as 0: absent; 1: <= 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was tested using an analysis of covariance (ANCOVA) model with ethnicity and baseline ISHAK HAI score as the fixed effects.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Score on a scale||Standard Error|Mean
1292230|NCT00107653|Secondary|Percentage of Participants With ISHAK Histological Activity Index Response|ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) in the ISHAK modified HAI (necroinflammatory) score at week 72. ISHAK modified HAI activity (necroinflammatory) score is a total score of periportal ± bridging (P/B) necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis grading as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5 = zone 3 multiple; 6 = panacinar necrosis and Focal necrosis grading as 0: absent; 1: < = 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation grading: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
1292231|NCT00107653|Secondary|Percentage of Participants With Biochemical Response|Biochemical response was defined as normal serum alanine transaminase (ALT) measurement. For ALT measurement the normal range is 5-37 IU/L.|At Weeks 4, 12, 24, 48, 60 and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
1292280|NCT00107042|Secondary|Assessment of Youth Understanding of Vaccine Trial and Informed Consent|Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions.|Screening||||Number of correct answers||Standard Deviation|Mean
1292755|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292232|NCT00107653|Secondary|Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time|The table below shows HCV-RNA log10 titers change from baseline values by study week and by study group. Analysis was performed for participants with a baseline and at least 1 post-baseline HCV-RNA assessment. HCV-RNA quantitation was performed using Roche High Pure System/COBAS® TaqMan® HCV Monitor Test. HCV-RNA measurement lower limit of detection was 28 IU/mL.|From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.|||Log10 IU/mL||Standard Error|Least Squares Mean
1292233|NCT00107653|Secondary|Percentage of Participants With Early Virologic Response at Week 12|Percentage of participants with an early virologic response defined as an HCV-RNA >=2 log10 drop from baseline or undetectable HCV-RNA measurement at Week 12 (lower limit of detection 28 IU/mL).|At Week 12|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
1292234|NCT00107653|Secondary|Percentage of Participants With Early Virologic Response at Week 4|Percentage of participants with an early virologic response defined as an HCVRNA >=1 log10 drop from baseline or undetectable HCV-RNA measurement at Week 4 (lower limit of detection 28 IU/mL).|At Week 4|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
1292235|NCT00107653|Secondary|Percentage of Participants Achieving Virologic Response|Percentage of participants achieving a virologic response defined as an undetectable HCV-RNA measurement (HCV-RNA <28 IU/mL by Roche High Pure System/COBAS TaqMan HCV Test)|At Weeks 4, 12, 24, 48, 60, and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
1292236|NCT00107653|Primary|Percentage of Participants With Sustained Virologic Response at Week 72|Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.|At Week 72|Intent-to-Treat (ITT) Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
1292237|NCT00107614|Primary|Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)|To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström’s Macroglobulinemia (WM), either untreated or previously treated.|3 years||||participant|||Number
1292238|NCT00107575|Primary|Smoking Abstinence at 2 Weeks|7 days of smoking abstinence confirmed biochemically at 2 weeks|2 weeks||||Participants|||Number
1292239|NCT00107575|Primary|Smoking Abstinence at 8 Weeks|7 days of smoking abstinence confirmed biochemically at 8 weeks|8 weeks||||Participants|||Number
1292240|NCT00107575|Primary|Smoking Abstinence at 16 Weeks|7 days of smoking abstinence confirmed biochemically at 16 weeks|16 weeks||||Participants|||Number
1292241|NCT00107575|Secondary|Alcohol Drinks Consumed Per Week Over a 2-week Period|Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor.|At 2, 8, 16, and 26-week follow-ups|The number of participants analyzed reflects the number of participants who provided at least some valid data on the Timeline Followback Interview|||drinks||Standard Deviation|Mean
1292242|NCT00107575|Primary|Smoking Abstinence at 26 Weeks|7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt|26 weeks|For analyses of smoking outcomes, missing data were considered smoking. However, at 26 weeks, 2 participants in ST-BI had died and therefore their data was left as missing for this period.|||participants|||Number
1292243|NCT00107536|Secondary|Expression Profile and Mutations of Genes Critical for EGFR and ERBB2 Signaling Pathways||Up to 3 years||||patients with mutations|||Number
1292244|NCT00107536|Secondary|Target-EGFR/EGFR-P Protein Expression|EGFR (exons 18-21)|Up to 3 years||||patients with somatic mutations|||Number
1292245|NCT00107536|Secondary|Overall Survival||up to 12.6 months||||months||95% Confidence Interval|Median
1292246|NCT00107536|Secondary|Median Overall Survival||Up to 3 years||||months||95% Confidence Interval|Median
1292247|NCT00107536|Secondary|Toxicity Profile Assessed Using NCI CTCAE Version 3.0|Percentage of patients with Adverse events accordng to NCI CTCAE version 3.0|Up to 3 years|All 26 patients were evaluable for toxicity analysis.|||percentage of patients|||Number
1292248|NCT00107536|Secondary|Progression-free Survival||up to 6 months||||months||95% Confidence Interval|Median
1292249|NCT00107536|Primary|Proportion of Patients Demonstrating Objective Response (PR+CR) as Defined by RECIST|PR (Partial Response) definded as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR (Complete Response) is defined as the disappearance of all target lesions.|Up to 3 years|Only 25 patients were evaluable for response (1 patient passed away before staging).|||patients|||Number
1292250|NCT00107380|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1292307|NCT00107042|Secondary|Quantitative Vaccine Response|The Log10 titer was used as the quantitative vaccine response.|Week 28|Subjects who had a wk 28 Hep B a'body titer and was no more than 8 wks after the 2nd vaccination were included. 1 subject was missing wk 28 titer. The a'body at week 48 was positive, so subject was treated as a responder for the binary measure. For the continuous a'body titer, the exact number could not be assumed; subject was treated as missing.|||Log10 titer (mIU/ml)||Standard Deviation|Mean
1292251|NCT00107380|Primary|Response Rate (Complete, Complete Unconfirmed, and Partial)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|6 months|All eligible patients who started treatment were included in the analysis|||participants|||Number
1292252|NCT00107380|Primary|Progression-free Survival (PFS) at 2 Years|Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0-2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1292253|NCT00107315|Secondary|Toxicity|"Number of participants with an adverse event.~Please refer to the adverse event reporting for more detail."|1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1292254|NCT00107315|Secondary|Median Survival||1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1292255|NCT00107315|Secondary|Response Rate|Overall Response (OR) = CR + PR.|1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1292256|NCT00107315|Primary|Time to Progression||1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1292257|NCT00107276|Secondary|Toxicity|Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)|Eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)|||Participants|||Number
1292258|NCT00107276|Secondary|Progression-free Survival and Overall Survival|"Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.~Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact.~Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression."|two years|All eligible patients|||months||95% Confidence Interval|Median
1292259|NCT00107276|Primary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Patients assessed at least every six weeks while on protocol treatment|Eligible patients with RECIST measurable disease|||participants|||Number
1292260|NCT00107198|Secondary|Grade 3 or 4 Toxicity||Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.|Eligible patients beginning AV-PC.|||Participants|||Number
1292261|NCT00107198|Secondary|Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients|To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy.|At 5 years|Of 188 patients enrolled, five ineligible patients were excluded. 136 patients received upfront AV-PC with or without RT per protocol. Of these 135 achieved CR with AV-PC and avoided RT. The median follow up among the 121 censored patients is 62.2 months (range 3.4-104.5).|||Probability participants||95% Confidence Interval|Number
1292262|NCT00107198|Secondary|Cure by Surgery Alone in Stage I Resected Patients|To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.|At 2 years|Of 188 patients enrolled, five ineligible patients were excluded. 52 patients with Stage IA, single node LPHL were enrolled with a confirmed total resection (TR). The median follow up among the 39 censored patients is 56.3 months (range 3.9-107.4).|||Probability participants||95% Confidence Interval|Number
1292263|NCT00107198|Secondary|Event-free Survival|Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment.|At 5 years|Of 188 patients enrolled, five ineligible patients were excluded from this analysis. 183 patients are included. The median follow-up time for the 155 censored patients is 61.2 months (range 0.03-107.4).|||Probability participants||95% Confidence Interval|Number
1292842|NCT00104572|Primary|Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density|bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo|1 year||||g/cm2||Standard Deviation|Mean
1292264|NCT00107198|Primary|Failure-free Survival (FFS)|The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause.|At 5 years|Of 188 patients enrolled, five ineligible patients and five patients who did not receive the upfront chemotherapy +/- RT per protocol were excluded from this analysis. 178 patients are included. The median follow-up for the 164 censored patients is 61.2 (range 3.5-107.4) months.|||Probability participants||95% Confidence Interval|Number
1292265|NCT00107172|Secondary|DLCO% Measured at Baseline and Month 3|"Pulmonary function tests included percentage predicted carbon~> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms."|3 months|All participants with complete pulmonary function test data at baseline and month 3.|||Percentage of Predicted||Full Range|Median
1292266|NCT00107172|Secondary|FEV1% Measured at Baseline and Month 3|Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms|3 months|All participants with complete pulmonary function test data at baseline and month 3.|||Percentage of Predicted||Full Range|Median
1292267|NCT00107172|Secondary|Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24|Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..|24 months|Participants who met the eligibility criteria and had SOBQ data at baseline, month 3, 12 or 24.|||units on a scale||Full Range|Median
1292268|NCT00107172|Secondary|Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24|Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.|24 months|Participants who met the eligibility criteria and had SF 36 data at baseline, month 3, 12 or 24.|||units on a scale||Full Range|Median
1292269|NCT00107172|Secondary|Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection|The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.|90 days|All Intent-to-Treat (ITT) participants.|||participants|||Number
1292270|NCT00107172|Secondary|Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection|Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|90 days|All Intent-to-Treat (ITT) participants.|||participants|||Number
1292271|NCT00107172|Secondary|Mortality Rates at 30- and 90-day After Sublobar Resection||90 days|All Intent-to-Treat (ITT) participants|||percentage of participants|||Number
1292272|NCT00107172|Secondary|Number of Participants Reported Distant Recurrence at 3 Years|Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant > metastatic disease (other organs).|3 years|All intent-to-treat participants.|||participants|||Number
1292273|NCT00107172|Secondary|Number of Participants Reported Regional Recurrence at 3 Years|Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.|3 years|All intent-to-treat participants.|||participants|||Number
1292274|NCT00107172|Secondary|Number of Participants Reported Local Recurrence at 3 Years|Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.|3 years|All intent-to-treat participants.|||participants|||Number
1292275|NCT00107172|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause.|Up to 5 years|All intent-to-treat (ITT) participants|||years||95% Confidence Interval|Median
1292276|NCT00107172|Primary|Time to Local Recurrence|Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.|Up to 3 years|All intent-to-treat (ITT) participants.|||years||95% Confidence Interval|Median
1292277|NCT00107120|Other Pre-specified|Children's Global Assessment Scale|Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).|At baseline and end of week 8|The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.|||Change in score||Standard Error|Mean
1292278|NCT00107120|Secondary|Clinical Global Impressions - Improvement|Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).|CGI-I score at the end of Week 8|The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.|||Score on scale||Standard Error|Mean
1292279|NCT00107120|Primary|Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score|Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.|Baseline to end of week 8|Efficacy analyses used Intent-To-Treat Population, which consisted of all patients who received at least 1 dose of double-blind study drug & who had at least 1 post-baseline assessment of the CDRS-R. LOCF technique was used to impute missing data. 1 escitalopram pt. did not have a post-baseline CDRS-R total score.|||Change in total score at endpoint||Standard Error|Mean
1292281|NCT00107042|Secondary|As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen|The subject was considered seroresponsive to Hepatitis B Surface Antigen if the serum antibody level was greater than or equal to 10 mIU/mL. Those who received only a single vaccination, whose second vaccination was outside of the specified time window, or other cases of protocol violations were excluded from the analysis.|Week 28|Subjects who completed both vaccinations according to the protocol were included in the analysis (as treated analysis). Those who only had 1 vaccination,whose 2nd vaccination was outside the specified time window, or other cases of protocol violations, were excluded from the analysis.|||percentage of participants|||Number
1292282|NCT00107042|Secondary|Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.|Week 28 and Week 76|Subjects in the Twinrix arm who had week 28 &/or wk 76 HepA serology results were included. For overall response analysis, if a subject was reactive at either wk 28 or wk 76, then the overall response for subject was considered “Positive”. If subject was non-reactive at both wk 28and wk 76, then the overall response for subject was “Negative”.|||percentage of participants|||Number
1292283|NCT00107042|Secondary|Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.|Week 76|Subjects in the Twinrix arm who had a Week 76 hepatitis A serology results were included in this analysis.|||percentage of participants|||Number
1292284|NCT00107042|Secondary|Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 1 month after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. If the Hepatitis A serology was reactive, then the participant was considered to have a positive response; if the Hepatitis A serology was non-reactive, then the participant was considered to have a negative response.|Week 28|The data for this analysis included those in the Twinrix arm who had week 28 hepatitis A serology results.|||percentage of participants|||Number
1292285|NCT00107042|Secondary|Immunogenicity to Hep B 18 Months After First Immunization|Persistence of protective antibody response was measured by presence or absence of 10 mIU/ml HepB surface antibody and geometric mean titer of the same antibody at Week 76|Week 76|"Participants who had a week 76 Hepatitis B antibody titer were included in this analysis.~One subject had an a'body titer at EOS visit but did not have a'body data at week 76. Since the EOS was close to week 76, the titer from EOS was recoded as the week 76 titer."|||Participants|||Number
1292286|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever used drugs not prescribed was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292287|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked marijuana was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292288|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever drank alcohol was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292289|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime female sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292308|NCT00107042|Primary|Qualitative Seroresponsiveness to Hepatitis B Surface Antigen|"Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows:~Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL."|Week (Wk) 28 (One month after the second immunization)|Participants were included if they were vaccinated at least once (Intent-to-Treat)|||Participants|||Number
1292290|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime male sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292291|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292292|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age of participants’ first unforced sexual encounter was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292293|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Sexual identity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292294|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked cigarettes was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292295|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. BMI at baseline was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292296|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Male participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of Wk 28 titer.|||Participants|||Number
1292297|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Females who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292298|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Race was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the wk 28 titer.|||Participants|||Number
1292299|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Hispanic ethnicity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292300|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292301|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE|Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292302|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT|Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum antibody level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Site effect was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292303|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.|Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Study arm was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
1292304|NCT00107042|Secondary|Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.|The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.|Week 28|The data for this analysis included those who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (as treated population).|||Participant|||Number
1292305|NCT00107042|Primary|Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)|Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. The number of participants with at least one SAE is reported.|Week 12, Week 24, Week 28, Week 76|The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline. The data presented are cumulative for events identified at each time point.|||participants|||Number
1292306|NCT00107042|Primary|Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))|Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported.|Week 12, Week 24, Week 28, Week 76|The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline at each visit visit. The data presented are cumulative for events identified at each time point.|||participants|||Number
1292328|NCT00106938|Secondary|Freedom From Mortality||0 to 1460 days||||percentage of participants|||Number
1292309|NCT00106964|Secondary|Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM|Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.|Week 28|All participants who had a Week 28 Hepatitis B serology result|||percentage of participants who responded|||Number
1292310|NCT00106964|Secondary|Response Rates in HIV+ Youth Within Each Study Arm by Study Duration|Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown.|Entry through Week 72|Population analyzed were those who had an antibody titer measured at Week 28.|||percentage of participants who responded|||Number
1292311|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth – ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY|The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator.|Baseline through Week 72|All enrolled participants were included in this analysis. The following no. of participants experienced at least one Grade 2 or higher abnormal labs by study arm.|||Events|Events||Number
1292312|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED|The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity.|Baseline through Week 72|All enrolled participants were included in this analysis of AEs that were definitely related to study drug. There were no AEs above Grade 2 considered to be definitely related to study drug.|||event|||Number
1292313|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED|The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity.|Baseline through Week 72|All enrolled participants were included in this analysis of all AEs that were possibly or probably related to study drug. There were no AEs above Grade 3 considered to be possibly or probably related to study drug.|||Events|||Number
1292314|NCT00106964|Primary|Sero-response to Hepatitis B Surface Antigen|The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.|Week 28|Participants who completed a Week 28 visit with a Hepatitis B serology result were included in this analysis.|||percentage of participants who resonded|||Number
1292315|NCT00106938|Secondary|Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years||0 to 5 years||||percentage of participants|||Number
1292316|NCT00106938|Secondary|Death or Major Stroke (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
1292317|NCT00106938|Secondary|Death or Stroke (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
1292318|NCT00106938|Secondary|Death, Stroke or Myocardial Infarction (MI) (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
1292319|NCT00106938|Secondary|Myocardial Infarction (MI) (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
1292320|NCT00106938|Secondary|All Stroke (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
1292321|NCT00106938|Secondary|Death (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
1292322|NCT00106938|Secondary|Freedom From All Stroke||0 to 1825 days||||percentage of participants|||Number
1292323|NCT00106938|Secondary|Freedom From All Stroke||0 to 1460 days||||percentage of participants|||Number
1292324|NCT00106938|Secondary|Freedom From All Stroke||0 to 1095 days||||percentage of participants|||Number
1292325|NCT00106938|Secondary|Freedom From All Stroke||0 to 730 days||||percentage of participants|||Number
1292326|NCT00106938|Secondary|Freedom From All Stroke||0 to 365 days||||percentage of participants|||Number
1292327|NCT00106938|Secondary|Freedom From Mortality||0 to 1825 days||||percentage of participants|||Number
1292344|NCT00106938|Secondary|Procedural Success|Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.|0 to 30 days post procedure|The analysis population is Procedure success is per subject basis including the attempted CAS (carotid artery stenting) procedure only. CEA group is not part of analysis population for procedure success.|||percentage of participants|||Number
1292345|NCT00106938|Secondary|Acute Device Success: Embolic Protection Device System|Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.|On day 0 after index procedure|Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.|||Percentage of devices|Devices|95% Confidence Interval|Mean
1292346|NCT00106938|Secondary|Acute Device Success: Xact Carotid Stent|Defined as attainment of final residual diameter stenosis of < 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.|On day 0 after index procedure|Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.|||percentage of devices|devices|95% Confidence Interval|Number
1292347|NCT00106938|Primary|Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.||0 to 365 days||||percentage of participants|||Number
1292348|NCT00106704|Secondary|Change From Baseline in FPG at Week 24|The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.|Baseline and 24 Weeks|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data after rescue were considered missing.|||mg/dL||95% Confidence Interval|Least Squares Mean
1292349|NCT00106704|Primary|Change From Baseline in A1C at Week 24|Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and 24 Weeks|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data obtained after glycemic rescue were considered missing.|||Percent||95% Confidence Interval|Least Squares Mean
1292350|NCT00106639|Secondary|Number of Participants With Discontinuation||Month 1, 2, 3, 4, 5, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292351|NCT00106639|Secondary|Electrocardiogram (ECG) Parameters|ECG parameters included PR interval, QT interval, corrected QT using Bazett's formula (QTcB) and QTc using Fridericia's formula (QTcF) interval, and QRS width.|Baseline, Month 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||millisecond||Standard Deviation|Mean
1292352|NCT00106639|Secondary|Alanine Aminotransferase (ALT) Level|ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||unit/liter||Standard Deviation|Mean
1292353|NCT00106639|Secondary|Hematocrit Level|The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||percentage of blood||Standard Deviation|Mean
1292354|NCT00106639|Secondary|Hemoglobin Level|Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||g/dL||Standard Deviation|Mean
1292355|NCT00106639|Secondary|Absolute Platelet Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points.|||platelets*10^3/mm^3||Standard Deviation|Mean
1292356|NCT00106639|Secondary|Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points.|||cells*10^3/mm^3||Standard Deviation|Mean
1292357|NCT00106639|Secondary|Number of Participants With Cytomegalovirus (CMV) Disease||Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication and based on time due to lost of follow-up, or up to Month 6. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||participants|||Number
1292358|NCT00106639|Secondary|BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load||Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||Copies/20 mcL plasma||Standard Deviation|Mean
1292625|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292359|NCT00106639|Secondary|Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load||Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||Copies/500 ng DNA||Standard Deviation|Mean
1292360|NCT00106639|Secondary|Number of Participants With Drug Usage|Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected.|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||participants|||Number
1292361|NCT00106639|Secondary|Supine Systolic and Diastolic Blood Pressure (BP)||Baseline, Day 2, 3, 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||millimeter of mercury||Standard Deviation|Mean
1292362|NCT00106639|Secondary|Number of Participants With Hypertriglyceridemia|Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each group respectively.|||participants|||Number
1292363|NCT00106639|Secondary|Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||mg/dL||Standard Deviation|Mean
1292364|NCT00106639|Secondary|Number of Participants With Hypercholesterolemia|Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood. Hypercholesterolemia was defined as a value of total serum cholesterol greater than 240 mg/dL.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||participants|||Number
1292365|NCT00106639|Secondary|Fasting Serum Glucose Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||mg/dL||Standard Deviation|Mean
1292366|NCT00106639|Secondary|Number of Participants With New Onset Diabetes Mellitus (NODM)||Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292367|NCT00106639|Secondary|Number of Participants With First Clinically Significant Infection|Clinically significant (Viral, Bacterial and Fungal) infection was defined as the presence of presumed or documented infection confirmed by culture, biopsy, genomic or serologic findings post-randomization and required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292368|NCT00106639|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 2 months after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Month 8 (2 months follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292369|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)|GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points.|||deciliter/mg (dL/mg)||Standard Deviation|Mean
1292370|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using MDRD equation. GFR by MDRD equation= 170 * (serum creatinine) ^ (-0.999)*(age in years)^(-0.176)*(0.762 if female) * (1.18 if black)*(blood urea nitrogen concentration)^(-0.170)*(serum albumin concentration)^(0.318). Normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each group respectively.|||mL/min/1.73 m^2||Standard Deviation|Mean
1292384|NCT00106639|Secondary|Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)|Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292646|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292371|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Cockcroft-Gault|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females, value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||mL/min||Standard Deviation|Mean
1292372|NCT00106639|Secondary|Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question|"Fifth question in the HCRUQ was “Upon discharge from the hospital, did you return to your previous place of residence?” and number of participants who responded yes or no to the question was reported."|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1292373|NCT00106639|Secondary|Healthcare Resource Utilization Questionnaire (HCRUQ)|Healthcare Resource Utilization Questionnaire (HCRUQ) was used to assess healthcare resources which included number of events such as physician and other health professional visits, number of treatments or diagnostic tests, number of hospitalizations, and number of emergency room visits.|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||events||Standard Deviation|Mean
1292374|NCT00106639|Secondary|End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)|ESRD-SCL:43-item disease specific self-administered questionnaire. Participants’ rated question“At the moment,how much do you suffer?”for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0-40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||units on a scale||Standard Deviation|Mean
1292375|NCT00106639|Secondary|36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||units on a scale||Standard Deviation|Mean
1292376|NCT00106639|Secondary|Trough Levels of Tacrolimus (TAC)||Pre-dose on Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1292377|NCT00106639|Secondary|Reticulocyte Count|Reticulocytes are slightly immature red blood cells in the blood. Reticulocyte counts are reported as cells*10^3 per cubic millimeter (cells*10^3/mm^3).|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||cells*10^3/mm^3||Standard Deviation|Mean
1292378|NCT00106639|Secondary|Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets|The absolute cell counts of cluster of differentiation 8 (CD8): Cytotoxic T-lymphocytes reactive with major histocompatibility complex-1 (MHC-I), CD19: B- Lymphocytes, CD56: natural killer cells were determined using FACS, a specialized type of flow cytometry which sorts a heterogeneous mixture based upon the specific light scattering and fluorescent characteristics of each cell.|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
1292379|NCT00106639|Secondary|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose on Day 1, 3, 7, 14, Month 1, 3, 6, between 1 to 2 hours post-dose at Month 3 and between 3 to 4 hours post-dose at Month 6|||||||
1292380|NCT00106639|Secondary|Number of Participants With Rejection|Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292381|NCT00106639|Secondary|Number of Participants Who Died||Month 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292382|NCT00106639|Secondary|Number of Participants With Graft Loss|Graft loss was defined as graft nephrectomy, participant's death due to graft loss, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292385|NCT00106639|Secondary|Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)|Ordered categorical severity of first BPAR was classified according to the Banff Classification. Grade IA: moderate tubulitis, grade IB: severe tubulitis, grade IIA: mild to moderate intimal arteritis, grade IIB: severe intimal arteritis, grade III: transmural arteritis. (Racusen et al: The Banff classification, 1999).|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292386|NCT00106639|Secondary|Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)|BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292387|NCT00106639|Secondary|Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3|BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Baseline up to Month 3|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292388|NCT00106639|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as the first occurrence of BPAR, graft loss, participant’s death or premature discontinuation of study medication for any reason.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292389|NCT00106639|Primary|Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is >90 milliliter/minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies those participants evaluable for this measure.|||mL/min||Standard Deviation|Mean
1292390|NCT00106639|Primary|Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6|BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Baseline up to Month 6|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1292391|NCT00106626|Secondary|Safety and Tolerability as Measured by the Number of Participants With Disease Progression|Number of participants with disease progression (protocol-mandated reason for discontinuation). Disease progression was determined by the principle investigator.|Any time during 8 cycle treatment period through 30 days after.|All participants. Treated Population includes all participants who received at least one dose and had efficacy measurements at baseline and at least one post baseline treatment.|||Participants|||Number
1292392|NCT00106626|Primary|Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level|MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if < 2 patients experience a DLT and is also the highest tolerated dose level in the cohort.|Cycle 1 (21 days)|A total of 52 participants were enrolled in this study. Six were violations pts (1 in Cohort C Dose Level 1, 1 in Cohort C Dose Level 2, 3 in Cohort D Dose Level 1, and 1 in Cohort D Dose Level 2) and were replaced. None of the violations pts had any DLTs in the first cycle of the study.|||Participants|||Number
1292393|NCT00106535|Secondary|End of Study: Change From Baseline in Joint Space Narrowing Score at Week 260|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation.|||Score on a scale||Standard Deviation|Mean
1292394|NCT00106535|Secondary|End of Study: Change From Baseline in Erosion Score at Week 260|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot and were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best ) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.|||Score on a scale||Standard Deviation|Mean
1292395|NCT00106535|Secondary|End of Study: Change From Baseline in Total Sharp-Genant Score at Week 260|Radiographs were taken of each hand and foot at Baseline and Week 260 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint).The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. The results were reported based on the treatment the patient was originally randomized to.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.|||Score on a scale||Standard Deviation|Mean
1292879|NCT00104104|Primary|The Number of Participants With Disease Progression||24 Months|Safety Population; enrolled patients who received at least one dose of study medication.|||Participants|||Number
1292396|NCT00106535|Secondary|End of Study: Percentage of Participants With Clinical Relevant Improvement in the SF-36 Score at Week 260|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. Clinically relevant improvement is defined as a ≥5 change from Baseline.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.|||Percentage of participants|||Number
1292397|NCT00106535|Secondary|End of Study: Percentage of Participants With Clinical Improvement in the FACIT-Fatigue Score at Week 260|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5 change from Baseline.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.|||Percentage of participants|||Number
1292398|NCT00106535|Secondary|End of Study: Change From Baseline in the Patient's Pain VAS at Week 260|"The patient assessed their pain at Baseline and Week 260 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.|||mm||Standard Deviation|Mean
1292399|NCT00106535|Secondary|End of Study: Change From Baseline in the Physician's Global Assessment of Disease Activity VAS at Week 260|The physician’s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.|||mm||Standard Deviation|Mean
1292400|NCT00106535|Secondary|End of Study: Change From Baseline in the Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) at Week 260|"The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.|||mm||Standard Deviation|Mean
1292401|NCT00106535|Secondary|End of Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 260|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. No imputation was used for missing HAQ score.|||Score on a scale||Standard Deviation|Mean
1292402|NCT00106535|Secondary|End of Study: Change From Baseline in Tender Joint Count at Week 260|68 joints were assessed at Baseline and Week 260 for tenderness and joints are classified as tender/not tender for a total possible swollen joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.|||Joint Count||Standard Deviation|Mean
1292403|NCT00106535|Secondary|End of Study: Change From Baseline in Swollen Joint Count at Week 260|66 joints were assessed at Baseline and Week 260 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.|||Joint Count||Standard Deviation|Mean
1292404|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 European League Against Rheumatism (EULAR) Good or Moderate Response at Week 260|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.|Baseline, Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.|||Percentage of participants|||Number
1292405|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 Low Disease Activity (LDA) at Week 260|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDA is defined as DAS28 ≤3.2.|Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.|||Percentage of participants|||Number
1292406|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 Remission at Week 260|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.|||Percentage of participants|||Number
1292407|NCT00106535|Secondary|End of Study: Percentage of Participants With ACR Response at Week 260|ACR20/50/70/90 response is defined as a ≥ 20/50/70/90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Baseline and Week 260. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments.|||Percentage of participants|||Number
1292408|NCT00106535|Secondary|Percentage of Participants Who Achieved Complete Clinical Response at Week 104|Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score].|104 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292409|NCT00106535|Secondary|Percentage of Participants Who Achieved Complete Clinical Response at Week 52|Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score]. Patients who achieve a complete clinical response at any time in the study are counted as responders, even if the response is not maintained.|52 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to ’Non Responder’.|||Percentage of participants|||Number
1292410|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 104|The percentage of participants who achieved ACR remission at any study visit up to Week 104. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|104 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'.|||Percentage of participants|||Number
1292411|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 52|The percentage of participants, who achieved ACR remission at any study visit up to Week 52. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|52 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'.|||Percentage of participants|||Number
1292504|NCT00106431|Primary|The Percent of Patients (Pts) With Objective Disease Response|The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response [CR], clinical complete response [CCR], or partial response [PR]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC).|6 months|Efficacy analysis based on interim analysis of data for as treated population|||Percent of participants|||Number
1292412|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 24|The percentage of participants, who achieved ACR remission at any study visit up to Week 24. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|24 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to ’Non Responder’.|||Percentage of participants|||Number
1292413|NCT00106535|Secondary|Percentage of Participants in Each Treatment Group Who Receive Escape Therapy|"In Escape 1, participants in the Tocilizumab 4 mg/kg + Methotrexate and Tocilizumab 8 mg/kg + Methotrexate groups received tocilizumab 8 mg/kg as escape therapy. Participants in the Placebo + Methotrexate group received tocilizumab 4 mg/kg as escape therapy.~In Escape 2, all participants received tocilizumab 8 mg/kg."|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis.|||Percentage of participants|||Number
1292414|NCT00106535|Secondary|Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response|Insufficient therapeutic response (patient not responding to the drug as assessed by the physician) was selected by the investigator as a reason that the patient withdrew from the study.|104 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. Data on escape therapy is excluded.|||Percentage of participants|||Number
1292415|NCT00106535|Secondary|Time to Onset of ACR70 by Treatment Group|Time in days until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR70 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.|||Days||95% Confidence Interval|Median
1292416|NCT00106535|Secondary|Time to Onset of ACR50 by Treatment Group|Time in days until ACR50 response. ACR50 response was defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR50 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.|||Days||95% Confidence Interval|Median
1292417|NCT00106535|Secondary|Time to Onset of ACR20 by Treatment Group|Time in days until ACR20 response. ACR20 response was defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR20 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.|||Days||95% Confidence Interval|Median
1292418|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 104 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 104 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||IU/mL||Standard Deviation|Mean
1292419|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 52 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 52 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||IU/mL||Standard Deviation|Mean
1292420|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 24 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 24 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||IU/mL||Standard Deviation|Mean
1292421|NCT00106535|Secondary|Change From Baseline in FACIT-F Score at Week 104|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292422|NCT00106535|Secondary|Change From Baseline in FACIT-F Score at Week 52|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292423|NCT00106535|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing FACIT-Fatigue scores. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292424|NCT00106535|Secondary|Change From Baseline in SF-36 Score at Week 104|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292425|NCT00106535|Secondary|Change From Baseline in SF-36 Score at Week 52|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicates improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292426|NCT00106535|Secondary|Change From Baseline in Quality Life Short Form-36 (SF-36) Score at Week 24|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. . Data was set to missing for patients who received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292427|NCT00106535|Secondary|Change From Baseline in HAQ Disability Index at Week 104|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8). Total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292428|NCT00106535|Secondary|Change From Baseline in HAQ Disability Index (HAQ-DI) at Week 52|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292429|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 104|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.|||Percentage of participants|||Number
1292430|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 52|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.|||Percentage of participants|||Number
1292431|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 24|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or on escape therapy was excluded.|||Percentage of participants|||Number
1292432|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 104|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.|||Percentage of participants|||Number
1292433|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 52|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.|||Percentage of participants|||Number
1292434|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 24|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy was excluded.|||Percentage of participants|||Number
1292435|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 104|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.|||Score on a scale||Standard Deviation|Mean
1292601|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 12|ITT Population, Population Description Number of Participants Analyzed = Number of participants at baseline and LOCF data|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1292436|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 80|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.|||Score on a scale||Standard Deviation|Mean
1292437|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 52|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.|||Score on a scale||Standard Deviation|Mean
1292438|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 24|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292439|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 104|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
1292440|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 80|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
1292441|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 52|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data for this outcome measure. Missing Week 52 data was imputed using Linear extrapolation. Data was set to missing for patients who withdrew or received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292442|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 24|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292443|NCT00106535|Secondary|Change From Baseline in Modified Total Sharp-Genant Score at Week 80|Radiographs were taken of each hand and foot at Baseline and Week 80 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
1292527|NCT00106353|Primary|Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 1|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability / incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292444|NCT00106535|Secondary|Change From Baseline in Modified Total Sharp-Genant Score at Week 24|Radiographs were taken of each hand and foot at Baseline and Week 24 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
1292445|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 104|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
1292446|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 52|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|52 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
1292447|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|24 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
1292448|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 104|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Percentage of participants|||Number
1292449|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 52|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.DAS28 Remission is defined as a DAS28 score <2.6.|Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Percentage of participants|||Number
1292450|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 remission is defined as a DAS28 score <2.6.|Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Percentage of participants|||Number
1292623|NCT00105989|Secondary|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase||Every Visit from Week 0 up to Week 10 (Acute)|Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.|||participants|||Number
1292451|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 104|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 104|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation was used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.|||Percentage of participants|||Number
1292452|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 52|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 52|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.|||Percentage of participants|||Number
1292453|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 24|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 24|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.|||Percentage of participants|||Number
1292454|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 104|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292455|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 52|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292456|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 24|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292457|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn Score at Week 104|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 104. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
1293660|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 6|Laboratory hematology lymphocytes|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
1292458|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn to Week 52|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 52. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|52 Weeks|Participants from the Intent-to-treat population(all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Full Range|Least Squares Mean
1292459|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn to Week 24|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 24. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|24 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
1292460|NCT00106535|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 104|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Percentage of participants|||Number
1292461|NCT00106535|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 52|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing for patients who received escape therapy.|||Percentage of participants|||Number
1292462|NCT00106535|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 104|Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 104 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||mm/hr||Standard Deviation|Mean
1292463|NCT00106535|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 104|Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 104 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||mg/dL||Standard Deviation|Mean
1292464|NCT00106535|Secondary|Change From Baseline in the Patient's Pain VAS at Week 104|"The patient assessed their pain at Baseline and Week 104 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292465|NCT00106535|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity at Week 104|"The physician's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292528|NCT00106353|Primary|Number of Participants Who Died: Part 1|Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292466|NCT00106535|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 104|"The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy|||Score on a scale||Standard Deviation|Mean
1292467|NCT00106535|Secondary|Change From Baseline in Tender Joint Count at Week 104|68 joints were assessed for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||Joint count||Standard Deviation|Mean
1292468|NCT00106535|Secondary|Change From Baseline in Swollen Joint Count at Week 104|66 joints were assessed at Baseline and Week 104 for swelling and joints were classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||Joint count||Standard Deviation|Mean
1292469|NCT00106535|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 52 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.|||mm/hr||Standard Deviation|Mean
1292470|NCT00106535|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 52|Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 52 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was made for missing data. All assessments were set to missing from the time a patient received escape therapy.|||mg/dL||Standard Deviation|Mean
1292471|NCT00106535|Secondary|Change From Baseline in the Patient's Pain VAS at Week 52|The patient assessed their pain at Baseline and Week 52 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. Data was set to missing for patients who received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292472|NCT00106535|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity at Week 52|The physician’s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing after the patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292473|NCT00106535|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 52|The patient’s global assessment of disease activity is assessed at Baseline and Week 52 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
1292474|NCT00106535|Secondary|Change From Baseline in Tender Joint Count at Week 52|68 joints were assessed at Baseline and Week 52 for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for missing tender joint data. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||Joint count||Standard Deviation|Mean
1292475|NCT00106535|Secondary|Change From Baseline in Swollen Joint Count at Week 52|66 joints were assessed at Baseline and Week 52 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||Joint count||Standard Deviation|Mean
1292476|NCT00106535|Secondary|Percentage of Participants With ACR70 Response Maintained for 6 Consecutive Months|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|104 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292477|NCT00106535|Secondary|Percentage of Participants With ACR70 Response at Week 104|ACR50 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292478|NCT00106535|Secondary|Percentage of Participants With ACR70 Response at Week 52|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292479|NCT00106535|Secondary|Percentage of Participants With ACR50 Response at Week 104|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292480|NCT00106535|Secondary|Percentage of Participants With ACR50 Response at Week 52|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292549|NCT00106249|Secondary|Motor Cortex Excitability (Short Intracortical Inhibition)|In 22 OCD patients enrolled in the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. For the paired-pulse (PP) measurements of short intracortical inhibition (SICI) the interstimulus interval (ISI) was set to 8-12 seconds on a continuous uniform distribution. The FPGA board samples the EMG data, controls the timing of the TMS stimuli, and also controls the intensity of the devices.|Through study completion|Independent sample t-test, right hemisphere SICI|||% change in conditioned/control MEP||Full Range|Mean
1292481|NCT00106535|Secondary|Percentage of Participants With ACR20 Response at Week 104|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292482|NCT00106535|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 52|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292483|NCT00106535|Primary|Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104|HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 2 years by using the AUC of the change from baseline in HAQ-DI score through week 104. Decreases in AUC of change from baseline in HAQ-DI indicated a gr eater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 104 HAQ-DI score, the AUC of the change from baseline was standardized to 104 weeks using the latest timepoint available for calculation of the AUC. A negative change from baseline indicated improvement.|Baseline to Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. For patients who received escape therapy, the HAQ-DI was set to missing from the time they entered escape.|||Score on a scale*week||Full Range|Least Squares Mean
1292484|NCT00106535|Primary|Change From Baseline in the Modified Total Sharp-Genant Score at Week 104|Radiographs of each hand and foot were taken at Baseline and Week 104 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or for patients on escape therapy the data is excluded. Missing data was imputed using linear extrapolation.|||Score on a scale||Standard Deviation|Mean
1292485|NCT00106535|Primary|Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52|HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 52 HAQ-DI score, the AUC of the change from baseline was standardized to 52 weeks using the latest timepoint available for calculation of the AUC. The mean was adjusted for region. A negative change from baseline indicated improvement.|Baseline to Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. All assessments were set to missing after a patient received escape therapy.|||Score on a scale*week||Full Range|Least Squares Mean
1292588|NCT00106028|Secondary|Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population|Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.|Month 12|ITT Population, Number of Participants Analyzed = Number of participants with baseline and Month 12 data|||Participants|||Number
1292486|NCT00106535|Primary|Change From Baseline in Modified Total Sharp-Genant Score at Week 52|Radiographs were taken of each hand and foot at Baseline and Week 52 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 (normalized from 98) and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 (normalized from 104) and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat (ITT) population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing week 52 data. Data collected after withdrawal or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
1292487|NCT00106535|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Week 24|HAQ-DI is a self-completed patient questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing HAQ-DI. All assessments were set to missing from the time a patient received escape therapy.|||Scores on a scale||Standard Deviation|Mean
1292488|NCT00106535|Secondary|Erythrocyte Sedimentation Rate: Mean Change From Baseline at Week 24|The Erythrocyte Sedimentation Rate (ESR) was measured in mm/hr. A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing ESR. All assessments were set to missing from the time a patient received escape therapy.|||millimeters/hour (mm/hr)||Standard Deviation|Mean
1292489|NCT00106535|Secondary|C-Reactive Protein (CRP): Mean Change From Baseline at Week 24|The serum concentration of C-Reactive Protein (CRP) is measured in mg/dL. A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing CRP. All assessments were set to missing from the time a patient received escape therapy.|||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
1292490|NCT00106535|Secondary|Patient's Pain VAS: Mean Change From Baseline at Week 24|The patient assessed their pain on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|Baseline and Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||mm||Standard Deviation|Mean
1292491|NCT00106535|Secondary|Physician's Global VAS: Mean Change From Baseline at Week 24|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity).|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||mm||Standard Deviation|Mean
1292492|NCT00106535|Secondary|Patient's Global Visual Analog Scale (VAS): Mean Change From Baseline at Week 24|The patient’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||millimeters (mm)||Standard Deviation|Mean
1292493|NCT00106535|Secondary|Tender Joint Count (68 Joint Count): Mean Change From Baseline at Week 24|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||joint count||Standard Deviation|Mean
1292494|NCT00106535|Secondary|Swollen Joint Count (66 Joint Count): Mean Change From Baseline at Week 24|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||joint count||Standard Deviation|Mean
1292647|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||actual count||Standard Deviation|Mean
1292495|NCT00106535|Secondary|Percentage of Participants With ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline,Week 24|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292496|NCT00106535|Secondary|Percentage of Participants With ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292497|NCT00106535|Primary|Percentage of Participants With American College of Rheumatology-ACR20 Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 24|Intent-to-treat (ITT) population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
1292498|NCT00106431|Secondary|Percent of Pts With Objective Disease Control|The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.|Up to 10 months|Efficacy analysis based on interim analysis of data for as treated population|||Percent of participants|||Number
1292499|NCT00106431|Secondary|Duration of Objective Disease Control (ODC)|For pts with confirmed ODC (pts with CR, CCR, PR, SD90 [stable disease for 90 days]) based on OPDREC, duration of ODC was summarized with descriptive statistics, including number of censored observations, and 25th, 50th, 75th percentiles of distribution, based on Kaplan-Meier product limit estimates. For pts with confirmed progressive disease (PD), duration of ODC was calculated from first date of study drug to first date of diagnosis of confirmed PD. For pts without confirmed PD, duration of ODC was calculated from first date of study drug to date of the last visit with any OPDREC data.|Up to 10 months; median duration of follow up was 6.0 months|Efficacy analysis based on interim analysis of data for as treated population|||Months||Full Range|Median
1292500|NCT00106431|Secondary|Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.|Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles.|Up to 10 months|Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of >=30 mm)|||participants|||Number
1292501|NCT00106431|Secondary|Time to Disease Progression|Time To Progression was defined as the duration from the date of the first study drug dose to the date of progression (PD). In this analysis, pts who did not progress were censored at their last evaluation with an OPDREC assessment.|Up to 10 months; median duration of follow up was 6.1 months|Efficacy analysis based on interim analysis of data for as treated population|||Months||Full Range|Median
1292502|NCT00106431|Secondary|Time to Objective Disease Response|Time to Objective Response was defined as the time in months from first dose date to the first date of objective disease response (later confirmed) and time to CCR was defined as the time in months from first dose date to the first date of CCR (later confirmed).|Up to 10 months|Efficacy analysis based on interim analysis of data for as treated population|||Months||Full Range|Median
1292503|NCT00106431|Secondary|Duration of Objective Disease Response|Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response [CCR], or partial response [PR]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment.|Up to 10 months; median duration of follow up was 5.1 months|Efficacy analysis based on interim analysis of data for as treated population|||Months||Full Range|Median
1292505|NCT00106392|Secondary|Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire|Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation."|||Overall Score of Urinary Function||Full Range|Median
1292506|NCT00106392|Secondary|Time to Achieve Response to Impotence Medications|Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who had a successful response to impotence medications were included in the calculations."|||Days||Full Range|Median
1292507|NCT00106392|Secondary|Percentage of Patients Considered Successful Responders to Impotence Medications|Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who used any impotence medications were included in the calculation."|||Percentage of Participants|||Number
1292508|NCT00106392|Secondary|Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score|Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who achieved normal erectile function are included in the calculation."|||Days||Full Range|Median
1292509|NCT00106392|Secondary|Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score|"Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.~Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months."|24 months|The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.|||Percentage of Participants|||Number
1292510|NCT00106392|Primary|Erectile Function Domain Score Between Treated and Untreated Groups|Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.|18 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants with complete IIEF questionnaire data at 18 months are included in the calculation."|||Erectile Function Domain Score||Full Range|Median
1292511|NCT00106353|Secondary|Number of Participants for Change From Baseline in the Phosphorylation of Mammalian Target of Rapamycin (mTOR) Pathway Proteins: Part 1 and Part 2|Optional bone marrow sampling for pharmacodynamic analysis of effects of study treatment. Data may not be collected for a majority of patients and was not to be summarized if collection was sparse.|Part 1:Baseline,1,2,6,24,168 hrs post-dose of Cycle 1;additional 0 (Pre-dose),24,72,96 hrs, Day 16 to 21 of cycle 2, EOT(within 30 days of last dose); Part 2:Baseline,Day16 to 21 in Cycle 2, at time of disease progression, EOT(within 30 days of last dose)|Data was not analyzed.||||||
1292512|NCT00106353|Secondary|Concentration in Plasma (Cp) and Concentration in Plasma at Time Zero (Cp Time 0): Part 1 and Part 2|Pharmacokinetic parameters determined in whole blood; derived from the concentration-versus-time profiles using noncompartmental analysis method. Measured as nanograms per milliliter (ng/mL).|Part 1: 0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2; Part2: 0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Data was not analyzed.||||||
1292513|NCT00106353|Secondary|Clearance (CL): Part 2|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||Standard Deviation|Mean
1292514|NCT00106353|Secondary|Area Under the Concentration-time Curve at Steady State (AUCss): Part 2|AUCss is a measure of the serum concentration of the drug at steady state. It is used to characterize drug absorption.|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr*ng/mL||Standard Deviation|Mean
1292589|NCT00106028|Secondary|Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT|Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.|Baseline and Month 36|ITT Population|||Participants|||Number
1292515|NCT00106353|Primary|Percentage of Participants With Objective Response (OR) at Week 12: Part 2|Measured as Complete response (CR), Very good partial response (VGPR), or Partial response (PR) on at least 2 occasions greater than or equal to (>=) 4 weeks apart within first 12 weeks. CR=disappearance of all primary and metastatic lesions; Homovanillic acid, Vanillymandelic acid (HVA/VMA) normal; bone marrow immunocytology negative. VGPR=disappearance of all metastatic lesions (residual areas of uptake on bone permitted); 90 to 99 percent (%) decrease in primary disease measurement; HVA/VMA normal or both decreased >90%. PR=at least 50% decrease in primary and metastatic disease. Number of bone sites decreased by at least 50%.|Week 12|Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.|||percentage of participants|||Number
1292516|NCT00106353|Primary|Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 1|Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292517|NCT00106353|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 2|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr*ng/mL||Standard Deviation|Mean
1292518|NCT00106353|Secondary|Plasma Decay Half-Life (t1/2): Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for.|||hr||Standard Deviation|Mean
1292519|NCT00106353|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 2||0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr||Full Range|Median
1292520|NCT00106353|Secondary|Average Plasma Concentration (Cavg): Part 2||0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1292521|NCT00106353|Secondary|Maximum Observed Plasma Concentration (Cmax): Part 2||0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1292522|NCT00106353|Secondary|Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 2|Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292523|NCT00106353|Secondary|Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 2|Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees C, respiratory rate >20 bpm, and systolic and diastolic BP >200/110 mmHg. Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292524|NCT00106353|Primary|Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 1|Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees Celsius (C), respiratory rate >20 beats per minute (bpm), and systolic and diastolic blood pressure (BP) >200/110 millimeters of mercury (mmHg). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292525|NCT00106353|Primary|Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 1|Dose reduction for individual participant allowed if a dose limiting toxicity (DLT) occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292526|NCT00106353|Primary|Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 1|Temporary interruption of study treatment; may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292529|NCT00106353|Primary|Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 1|TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period. National Cancer Institute (NCI)-graded Common Toxicity Criteria (CTC) provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292530|NCT00106353|Primary|Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 1|TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292531|NCT00106353|Secondary|Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 2|Dose reduction for individual participant allowed if a DLT occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292532|NCT00106353|Secondary|Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Temporary interruption of study treatment may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292533|NCT00106353|Secondary|Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 2|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292534|NCT00106353|Secondary|Number of Participants Who Died: Part 2|Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292535|NCT00106353|Secondary|Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 2|Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292536|NCT00106353|Secondary|Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 2|Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292537|NCT00106353|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292538|NCT00106353|Secondary|Percentage of Participants Exhibiting Freedom From Progression at Week 12: Part 2|Freedom from progression measured as Stable Disease (SD) or better and no Progressive Disease (PD); (CR+VGPR+Mixed Response [MR]+PR+SD). CR=disappearance of all primary and metastatic lesions. VGPR=disappearance of all metastatic lesions. MR=no new lesions; at least 50% decrease in any 1 disease measurement with <50% decrease in any other disease measurement or an increase of <25% in any lesion). SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=at least a 25% increase in any disease measurement; or the appearance of 1 or more new lesions.|Week 12|Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.|||percentage of participants||95% Confidence Interval|Number
1292590|NCT00106028|Secondary|Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT|Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.|Baseline and Month 12|ITT Population|||Participants|||Number
1293661|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 3|Laboratory hematology lymphocytes|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
1292539|NCT00106353|Secondary|Percentage of Participants With Best Overall Response: Part 1|Best overall response is the best response recorded from baseline until disease progression or recurrence. Measured as CR, PR, SD, PD, or Unknown. CR=disappearance of all primary and metastatic lesions. PR=at least a 50% decrease in primary disease measurement. SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=any new lesion; at least a 25% increase in any disease measurement (reference smallest disease measurement recorded since start of treatment); or appearance of 1 or more new lesions. Tumor response considered Unknown if assessment prior to Day 37.|Baseline until disease progression or recurrence (actual greatest response day is up to Day 49)|Efficacy evaluable population included all participants who received at least 3 doses of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.|||percentage of participants|||Number
1292540|NCT00106353|Secondary|Volume of Distribution at Steady State (Vss): Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||Liter||Standard Deviation|Mean
1292541|NCT00106353|Secondary|Clearance (CL): Part 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||Liter/hr||Standard Deviation|Mean
1292542|NCT00106353|Secondary|Area Under the Concentration-Time Curve (AUC): Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||hr*ng/mL||Standard Deviation|Mean
1292543|NCT00106353|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 1|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||hr*ng/mL||Standard Deviation|Mean
1292544|NCT00106353|Secondary|Plasma Decay Half-Life (t1/2): Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||hr||Standard Deviation|Mean
1292545|NCT00106353|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 1||0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||hr||Standard Deviation|Mean
1292546|NCT00106353|Secondary|Maximum Observed Plasma Concentration (Cmax): Part 1||0 (pre-dose), 1, 2, 6, 24, and 168 hours (hrs) post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1292547|NCT00106353|Secondary|Number of Participants Who Reached Maximum Tolerated Dose Due to Dose Limiting Toxicity: Part 1|Maximum tolerated dose (MTD) defined as the dose level at which >=2 of 3 participants or >=2 of 6 participants if the dose level had been expanded, experienced a dose limiting toxicity (DLT) by day 21 after the first dose of study treatment. DLT defined as failure to recover to NCI-CTCAE version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of > 3 weeks) unless the investigator and the medical monitor agree that the subject should remain in the study.|Baseline up to Month 6|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1292548|NCT00106353|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to End of Treatment (EOT) (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1293662|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 1|Laboratory hematology lymphocytes|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
1292550|NCT00106249|Secondary|Motor Cortex Excitability (Motor Threshold)|In 22 OCD patients, who completed the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. Specifically, the software delivers TMS pulses and automatically determines motor threshold (MT); a descending staircase method is utilized, starting at the intensity at which the optimal site selection for the MT is determined. After each stimulus in the MT experiments, the software would prompt the user to confirm the automated MEP-detection.|Through study completion|repeated measure ANOVA, time X group interaction, right hemisphere MT|||% MT change on right hemisphere||Full Range|Mean
1292551|NCT00106249|Primary|Clinical Improvement (Yale-Brown Obsessive Compulsive Scale/Y-BOCS)|Response rate was defined as a decrease >25% on the YBOCS-SR. Y-BOCS-Self Report (Baer et al. 1993) is very similar to the clinician-administered one, and has shown excellent internal consistency and test-retest reliability, performing somewhat better than the interview (Steketee et al., 1996); subjects are asked to focus on the main obsessions and main compulsions and to answer five questions: time spent, interference, distress, resistance, and control. Consistent with the interview format, subjects rate each item on a 0 (none) to 4 (extreme) scale.|Through study completion||||percentage of participants|||Number
1292552|NCT00106184|Secondary|20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI])|Number of participants with a 20% improvement in MMT over baseline on two consecutive time points.|Week 44 of treatment phase|Intention to Treat (ITT)|||Participants|||Number
1292553|NCT00106184|Secondary|Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8|"The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.~Core Set Measures Included:~Manual Muscle Testing (MMT)- Muscle Strength~Physician Global Disease Activity VAS Score~Health Assessment Questionnaire Index Score - Physical Function~Patient Global Assessment of Disease Activity VAS score~Extramuscular Activity - Myositis Disease Activity Assessment Tool~2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)"|Week 8 of the treatment phase|Intention to Treat (ITT)|||participants|||Number
1292554|NCT00106184|Primary|Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients|"The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.~Core Set Measures Included:~Manual Muscle Testing (MMT)- Muscle Strength~Physician Global Disease Activity VAS Score~Health Assessment Questionnaire Index Score - Physical Function~Patient Global Assessment of Disease Activity VAS score~Extramuscular Activity - Myositis Disease Activity Assessment Tool~2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)"|Week 44 of treatment phase|Intention to Treat (ITT)|||Weeks||Full Range|Median
1292555|NCT00106119|Secondary|Apolipoprotein B at Liothyronine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
1292556|NCT00106119|Secondary|Apolipoprotein B at Levothyroxine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
1292557|NCT00106119|Secondary|Apolipoprotein A-I at Liothyronine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
1292558|NCT00106119|Secondary|Apolipoprotein A-I at Levothyroxine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
1292559|NCT00106119|Secondary|Left Ventricle Mass Index at Liothyronine Treatment Phase||One month of therapy.||||g/m^2||Standard Deviation|Mean
1292560|NCT00106119|Secondary|Left Ventricle Mass Index at Levothyroxine Treatment Phase||One month of therapy.||||g/m^2||Standard Deviation|Mean
1292561|NCT00106119|Secondary|Resting Energy Expenditure at Liothyronine Treatment Phase||One month of therapy.||||kcal/24 hour||Standard Deviation|Mean
1292562|NCT00106119|Secondary|Resting Energy Expenditure at Levothyroxine Treatment Phase||One month of therapy.||||kcal/24 hour||Standard Deviation|Mean
1292563|NCT00106119|Secondary|Triglycerides at Liothyronine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
1292564|NCT00106119|Secondary|Triglycerides at Levothyroxine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
1292565|NCT00106119|Secondary|Total Cholesterol at Liothyronine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
1292566|NCT00106119|Primary|Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase||One month of therapy||||mg/kg/min||Standard Deviation|Mean
1292567|NCT00106119|Secondary|Total Cholesterol at Levothyroxine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
1292568|NCT00106119|Primary|Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase||One month of therapy.||||mg/kg/min||Standard Deviation|Mean
1292569|NCT00106106|Primary|Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 25|The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.|Day 25||||Ratio of glutamate to creatine||Standard Error|Mean
1292591|NCT00106028|Secondary|New Morphometric Vertebral Fracture at Month 36, ITT Population|Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.|Baseline and Month 36|ITT Population|||Participants|||Number
1292624|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292570|NCT00106106|Primary|Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 4|The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.|Day 4|The analysis of participants was per protocol, i.e., all subjects who completed two MRS scans(Day 4 and Day 25) and for whom there were two measures of the glutamate/creatine ratio|||Ratio of glutamate to creatine||Standard Error|Mean
1292571|NCT00106080|Secondary|Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.|We measured the difference between intervention and control group patients reporting having had a discussion with their clinician about treatment preferences at their last clinic visit.|Assessed 2 weeks after targeted clinic visit||||Proportion of participants reporting||95% Confidence Interval|Number
1292572|NCT00106080|Primary|Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale|The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.|Measured at enrollment and 2 weeks after targeted clinic visit||||units on a scale||95% Confidence Interval|Mean
1292573|NCT00106028|Secondary|Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population|Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]|Baseline and Month 36|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data|||Change in Annualized Growth Velocity||95% Confidence Interval|Least Squares Mean
1292574|NCT00106028|Secondary|Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population|Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]|Baseline and Month 12|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data|||Change in Annualized Growth Velocity||95% Confidence Interval|Least Squares Mean
1292575|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 36, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 36|ITT Population|||Years||95% Confidence Interval|Least Squares Mean
1292576|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 24, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 24|ITT Population|||Years||95% Confidence Interval|Least Squares Mean
1292577|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 12, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 12|ITT Population|||Years||95% Confidence Interval|Least Squares Mean
1292578|NCT00106028|Secondary|Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population|Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al.|Baseline and Month 12|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1292579|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292580|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292581|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Endpoint / Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292582|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 36, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 36 Months|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292583|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 24, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 24 Months|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292584|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 12, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 12 Months|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292585|NCT00106028|Secondary|Number of Clinical Fractures, Month 12, ITT Population|Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.|12 Months|ITT Population|||Participants|||Number
1292586|NCT00106028|Secondary|Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population|Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.|Time to First Event (days) up to 12 Months|ITT Population|||Probability of Fractures|||Number
1292587|NCT00106028|Secondary|Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population|Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.|Month 12|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data|||Participants|||Number
1292592|NCT00106028|Secondary|New Morphometric Vertebral Fracture at Month 12, ITT Population|Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.|Baseline and Month 12|ITT Population|||Participants|||Number
1292602|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 36|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1292603|NCT00106028|Primary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.|Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292604|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 24|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1292605|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 12|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1292606|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 36, ITT Population||Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292607|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 24, ITT Population||Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292608|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 12, ITT Population||Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292609|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population||Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292610|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population||Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292611|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population||Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292612|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 36, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 36|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1292613|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 24, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 24|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1292614|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 12, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 12|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
1292615|NCT00106028|Secondary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.|Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292616|NCT00106028|Secondary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.|Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
1292617|NCT00106002|Secondary|Overall Survival Time|Defined as the time from date of first dose to time of death due to any cause.|every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up|Intent to treat population (in order to follow protocol, one patient who did not take any study drug was excluded from this analysis)|||months||Full Range|Median
1292618|NCT00106002|Secondary|Progression-Free Survival Time|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|Intent to treat population (in order to follow protocol, one patient who did not take study drug was excluded from this analysis)|||months||Full Range|Median
1292619|NCT00106002|Secondary|Duration of Tumor Response|Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|Only applies to patients who had a complete or partial response|||months||Full Range|Median
1292620|NCT00106002|Secondary|Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)|Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).|every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up||||participants|||Number
1292621|NCT00106002|Primary|Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression||||participants|||Number
1292622|NCT00105989|Secondary|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase||Every Visit from Week 10 up to Week 34 (Continuation)|Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.|||participants|||Number
1299121|NCT00000479|Primary|Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)||Average follow-up 10.1 years||||Participants|||Number
1292626|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Units per Liter||Standard Deviation|Mean
1292627|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||grams per Liter||Standard Deviation|Mean
1292628|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Giga per Liter||Standard Deviation|Mean
1292629|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||femtoliters||Standard Deviation|Mean
1292630|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292631|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292632|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Giga per Liter||Standard Deviation|Mean
1292633|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292634|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Actual count||Standard Deviation|Mean
1292635|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Units per Liter||Standard Deviation|Mean
1292636|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Tera per Liter||Standard Deviation|Mean
1292637|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292638|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||micromoles per Liter||Standard Deviation|Mean
1292639|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||micromoles per Liter||Standard Deviation|Mean
1292640|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292641|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||grams per Liter||Standard Deviation|Mean
1292642|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||micromoles per Liter||Standard Deviation|Mean
1292643|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||grams per Liter||Standard Deviation|Mean
1292644|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292645|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Giga per Liter||Standard Deviation|Mean
1292648|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Units per Liter||Standard Deviation|Mean
1292649|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Giga per Liter||Standard Deviation|Mean
1292650|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292651|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
1292652|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||grams per Liter||Standard Deviation|Mean
1292653|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||mm Hg||Standard Error|Least Squares Mean
1292654|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||mm Hg||Standard Deviation|Mean
1292655|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||beats per minute||Standard Error|Least Squares Mean
1292656|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||beats per minute||Standard Deviation|Mean
1292657|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||kilograms||Standard Error|Least Squares Mean
1292658|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||kilograms||Standard Deviation|Mean
1292659|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|N=Number of female randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Female patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292660|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|N=Number of male randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Male patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292661|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of female enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of female patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292662|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of male enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of male patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292696|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 5 years of follow-up (as determined by CTCAE 3.0). Incidence is shown by hormone type and risk group.|5 years||||percentage of participants||95% Confidence Interval|Number
1292663|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients who work for pay and missed work due to illness. Intent to Treat analysis.|||hours||Standard Error|Least Squares Mean
1292664|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase who work for pay and missed work due to illness. Number of patients who entered the Continuation Phase who work for pay and missed work due to illness. Intent to Treat analysis.|||hours||Standard Deviation|Mean
1292665|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients who work for pay. Intent to Treat analysis.|||hours||Standard Error|Least Squares Mean
1292666|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase who work for pay. Number of patients who entered the Continuation Phase who work for pay. Intent to Treat analysis.|||hours||Standard Deviation|Mean
1292667|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 through Week 86 (Maintenance Phase)|Number of randomized patients who indicated they had visits to specified health care provider. Intent to Treat analysis.|||visits||Standard Error|Least Squares Mean
1292668|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 through Week10 (Acute) through Week 34 (Continuation)|"Number of enrolled patients in Acute Phase and number who entered Continuation Phase who indicated they had visits to specified health care provider. Intent to Treat analysis. Note: Other Mental Health Care Worker wasn't included in table (1 patient in Acute). Other Health Care Worker wasn’t included in table (2 patients in Continuation)."|||visits||Standard Deviation|Mean
1292669|NCT00105989|Secondary|Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase|Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292670|NCT00105989|Secondary|Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase|Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292671|NCT00105989|Secondary|Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292672|NCT00105989|Secondary|Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292673|NCT00105989|Secondary|Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase|The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292674|NCT00105989|Secondary|Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases|The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292675|NCT00105989|Secondary|Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292676|NCT00105989|Secondary|Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292677|NCT00105989|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase|Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292678|NCT00105989|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases|Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292679|NCT00105989|Secondary|Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 86 (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292680|NCT00105989|Secondary|Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292681|NCT00105989|Secondary|Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292682|NCT00105989|Secondary|Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292697|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 3 years of follow-up (as determined by CTCAE 3.0). Incidence is grouped by hormone type and risk group|3 years||||percentage of participants||95% Confidence Interval|Number
1292683|NCT00105989|Secondary|Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
1292684|NCT00105989|Secondary|Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
1292685|NCT00105989|Secondary|Loss of Response at Any Time|Loss of response was defined as a HAMD-17 total score >9 and a CGI-Severity score >2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.|Every Visit from Week 35 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing post-baseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.|||participants|||Number
1292686|NCT00105989|Secondary|Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days|Worsening occurs if patient had a >=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score >=3 at any time during the double-blind maintenance therapy phase.|Every Visit from Week 34 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing post-baseline assessment during the double blind maintenance therapy phase. Intent to Treat analysis.|||percentage of participants|||Number
1292687|NCT00105989|Secondary|Recurrence Count|Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.|Every Visit from Week 35 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing postbaseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.|||participants|||Number
1292688|NCT00105989|Primary|Percentage of Participants With Depressive Recurrence After Time (t) in Days|Recurrence: Clinical Global Impression-Severity (CGI-S) score >=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.|Every Visit from Week 34 up to Week 86 (Maintenance Phase)|All randomized patients. Intent to Treat analysis.|||percentage of participants|||Number
1292689|NCT00105586|Secondary|Quality of Life|Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).|Measured at Week 12|Quality of Life scales were collected on all participants randomized to Escitalopram and placebo|||units on a scale||Standard Deviation|Mean
1292690|NCT00105586|Primary|Response Using Clinical Global Impressions-Improvement Scale (CGI-I)|Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).|Measured at Weeks 1-12||||participants|||Number
1292691|NCT00105560|Secondary|Overall Survival|the percentage of participants surviving after five and seven years and at the end of follow-up in the overall population. Survival is shown by risk and histological group.|5 years, 7 years, 10 years|Follow-up for the 10 year follow-up is still ongoing and the data is not yet available.|||percentage of participants surviving||95% Confidence Interval|Number
1292692|NCT00105560|Secondary|Progression Free Survival|The percentage of participants with progression free survival after five, seven, and ten years in the overall population and by risk and histological group.|5 years, 7 years, 10 years|Follow-up is ongoing and data is not yet available for the 10 year follow-up time point.|||percentage of participants surviving||95% Confidence Interval|Number
1292693|NCT00105560|Secondary|Mean Change Per-Year in Neurocognitive Outcomes|The mean change per-year in neurocognitive outcomes as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full Scale Intelligence Quotient (FSIQ) of children with the use of four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale that has an average score of 100 and standard deviation of 15 points in the general population, meaning on average 68% of test takers would be within +/- 15 points of 100 and 95% within +/- 30 points. Higher scores represent higher intelligence and lower score represent reduced intelligence. Participants were assessed for changes in score with the use of repeated testing during a median follow-up time of 5.2 years. Repeated measures were taken at baseline, 1, 3, 5, and 7 years or until the participant was not available for evaluation (whichever comes first).|Baseline, 1, 3, 5, 7 years|The study participants that were evaluated for changes in neurocognitive outcomes|||units on a scale||95% Confidence Interval|Mean
1292694|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 10 Years|percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) by the end of study follow-up (as determined by CTCAE 3.0) by hormone type and risk group.|End of follow-up||2021-12-31|12/2021||||
1292695|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 7 years of follow-up, as determined by CTCAE 3.0. Incidence is shown by hormone type and risk group|7 years||||percentage of participants||95% Confidence Interval|Number
1292732|NCT00105196|Other Pre-specified|Clinical Global Impression (CGI)-Improvement Response|Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).|Baseline (Week 8) and Week 14||||Participants|||Number
1292698|NCT00105560|Primary|Cumulative Incidence of Ototoxicity|Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years.|3 Years, 5 years, 7 years, 10 years|The overall study population after the stated durations of follow-up. Follow-up is ongoing and data is not yet available for the 10 year time point.|||percentage of participants||95% Confidence Interval|Number
1292699|NCT00105534|Secondary|Participants Who Achieved Bacteriological Eradication|Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).|Visit 3 (Day 6-7)|Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.|||Participants|||Number
1292700|NCT00105534|Primary|Participants Who Achieved Clinical Resolution|Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.|Visit 3 (Days 6-7)|Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.|||Participants|||Number
1292701|NCT00105521|Secondary|Change From Baseline in UPDRS Part III Total Score at Week 12|The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson’s disease. UPDRS Part III total score was the sum of the 27 answers (rated on 0 to 4-point scale) related to motor examination, and ranged from 0-108. Higher scores indicated worse motor function. Change from baseline in UPDRS Part III total score, assessed during on-time (time when the participant has no parkinsonian symptoms) as well as off-time (time when the patient experiences increased parkinsonian symptoms), is reported.|Baseline, Week 12|modified ITT population.|||units on a scale||Standard Deviation|Mean
1292702|NCT00105521|Secondary|Change From Baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12|The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson’s disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.|Baseline, Week 12|Modified ITT population.|||units on a scale||Standard Deviation|Mean
1292703|NCT00105521|Secondary|Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12|Modified AIMS was a 7-item investigator-assessed scale to assess severity of dyskinesia. Each item was rated on a 0 (none) to 4 (severe) scale. Modified AIMS score was sum of the all item scores and ranged from 0 to 28, where higher score indicated increased severity. Modified AIMS score in resting state as well as with activity is reported.|Baseline, Week 12|Modified ITT population.|||units on a scale||Standard Deviation|Mean
1292704|NCT00105521|Primary|Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12|On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.|Baseline, Week 12|Modified intent-to-treat (ITT) population included all randomized participants who received at least one treatment dose and who had at least one follow-up visit assessment for an efficacy target outcome.|||hours/day||Standard Deviation|Mean
1292705|NCT00105508|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24|The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson’s disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline.|Baseline, Week 24|"Intent to treat population included all subjects who were randomized in the study. Here Overall Number of Participants Analyzed signifies those subjects who were evaluated for this outcome measure."|||units on a scale||Standard Deviation|Mean
1292706|NCT00105508|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12|The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson’s disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline.|Baseline, Week 12|"Intent to treat population included all subjects who were randomized in the study. Here Overall Number of Participants Analyzed signifies those subjects who were evaluated for this outcome measure."|||units on a scale||Standard Deviation|Mean
1292707|NCT00105508|Primary|Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24|Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson’s disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.|Week 24|Intent to treat population included all subjects who were randomized in the study.|||percentage of subjects|||Number
1292733|NCT00105196|Other Pre-specified|MADRS Response|Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).|Baseline (Week 8) and Week 14||||participants|||Number
1292708|NCT00105508|Primary|Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12|Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson’s disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.|Week 12|Intent to treat population included all subjects who were randomized in the study.|||percentage of subjects|||Number
1292709|NCT00105482|Secondary|Cigarettes Smoked Per Day.|Average number of cigarettes smoked per day at 26 weeks.|26 weeks|Patients were analyzed per protocol.|||number of cigarettes||Standard Deviation|Mean
1292710|NCT00105482|Secondary|Point Prevalence Smoking Abstinence at 6 Weeks|The number of people that were abstinent from cigarette smoking at 6 weeks.|6 weeks|All patients who were randomized comprised the primary ITT population.|||participants|||Number
1292711|NCT00105482|Secondary|Weight Gain at 6 Weeks.|Weight change from baseline measured at 6 weeks.|6 weeks|All patients who were randomized comprised the primary ITT population.|||pounds||Standard Deviation|Mean
1292712|NCT00105482|Primary|Point Prevalence Smoking Abstinence at 26 Weeks.|The number of people that were abstinent from cigarette smoking at 26 weeks.|26 weeks|All patients who were randomized comprised the primary ITT population.|||participants|||Number
1292713|NCT00105482|Primary|Weight Gain at 26 Weeks.|Weight change from baseline measured at 26 weeks.|26 weeks|All patients who were randomized comprised the primary ITT population.|||pounds||Standard Deviation|Mean
1292714|NCT00105469|Secondary|Number of Participants Who Achieved Bacterial Eradication at Visit 3|Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).|Visit 3 (Day 6)|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."|||Participants|||Number
1292715|NCT00105469|Primary|Number of Participants Who Achieved Clinical Resolution at Visit 3|Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).|Visit 3 (Day 6)|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."|||Participants|||Number
1292716|NCT00105443|Post-Hoc|Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire|PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value. At the cut-off date for this analysis, one more patient data has been gained.|from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment|In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 Day 1 or, for those discontinuing prior to that visit, at the end of study. It was summarized as number of patients with change from baseline <8 to ≥8 points for each treatment group up to the cutoff date of 09 Feb 2007.|||Participants|||Number
1292717|NCT00105443|Post-Hoc|Disease Control (DC)|The DC is defined as the number of subjects with a best response rating of CR, PR, or SD that is maintained at least 28 days from the first manifestation of that rating.|from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment|The disease control rate for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors (RECIST) up to the cutoff date of 09 Feb 2007|||Participants|||Number
1292718|NCT00105443|Post-Hoc|Time to Progression (TTP)|TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 23 months after start of enrollment|The independent radiological review as initially scheduled for the interim analysis did not continue after 12 May 2006. The primary analysis of TTP for the ITT population after 12 May 2006 up to the cutoff date of 09 Feb 2007 was based on the Investigator radiological assessments|||Days||95% Confidence Interval|Median
1292719|NCT00105443|Post-Hoc|Time to Symptomatic Progression (TTSP)|TTSP was defined as the time from randomization to the first documented symptomatic progression|from randomization to the first documented symptomatic progression until an average 5.7 months later up to the data cut-off date approximately 23 months after start of enrollment|For subjects (in the ITT population) who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of last FACT FHSI-8 questionnaire assessment (upon an interim review by the Data Monitoring Committee on 09 Feb 2007), when the study was considered positive for its primary endpoint, OS, and was stopped early.|||Days||95% Confidence Interval|Median
1292720|NCT00105443|Post-Hoc|Overall Survival|Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|from randomization to death due to any cause until an average 8.5 months later up to the data cut-off date approximately 23 months after start of enrollment|The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment|||Days||95% Confidence Interval|Median
1292721|NCT00105443|Secondary|Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire|PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.|from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment|In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline <8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006|||Participants|||Number
1292722|NCT00105443|Secondary|Disease Control (DC)|The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.|time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment|In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors [RECIST])|||Participants|||Number
1292723|NCT00105443|Secondary|Time to Progression (TTP)|TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment|The primary analysis of TTP for the ITT population was based on the independent radiological review for the interim analysis. The cut-off date chosen for the analysis of radiological progression events was 12 May 2006|||days||95% Confidence Interval|Median
1292724|NCT00105443|Primary|Time to Symptomatic Progression (TTSP)|TTSP was defined as the time from randomization to the first documented symptomatic progression.|from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment|This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.|||days||95% Confidence Interval|Median
1292725|NCT00105443|Primary|Overall Survival (OS)|Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment|In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.|||days||95% Confidence Interval|Median
1292726|NCT00105235|Secondary|Proportion of Participants Successfully Withdrawn and Remain Off Immunosuppressants|This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee, were successfully withdrawn from immunosuppressants, and remained off immunosuppressants at the time the trial ended. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks and do not restart immunosuppressant drugs after successful withdrawal.|From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)|Intent-to-treat|||Proportion of Participants|||Number
1292727|NCT00105235|Secondary|Proportion of Participants Successfully Withdrawn From Immunosuppressants|This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks.|From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)|Intent-to-treat|||Proportion of Participants|||Number
1292728|NCT00105235|Secondary|Number of Events: Immunosuppression-related Complications|Certain events are associated with immunosuppression. This measure looks at post-transplant infection, post-transplant malignancies, post-transplant diabetes, and post-transplant renal failure. Immunosuppression withdrawal is intended to reduce these type of events. However, reduction in immunosuppression can lead to complications in liver and renal function, as measured by acute rejection, chronic rejection, and post-transplant renal failure. Lower numbers for any of these events indicates greater success with transplantation and immunosuppression withdrawal (where applicable)|From transplantation until study completion or participant termination (participants followed up to 60 months)|Safety Sample|||Events|||Number
1292729|NCT00105235|Secondary|Proportion of Participants Who Had Graft Loss or Death|Proportion of participants who had liver graft loss or who died or terminated from the study within 2 years of initiating immunosuppression withdrawal|Within 2 years after initiation of immunosuppression withdrawal|Participants who initiated immunosuppression withdrawal|||Proportion of Participants|||Number
1292730|NCT00105235|Primary|Proportion of Participants Who Have Graft Loss or Death|Proportion of participants who had liver graft loss or who died within 1 year of undergoing transplantation. Note: Participants who discontinued treatment or terminated the study prior to 1 year post transplantation are considered treatment failures and are included in this measure.|Within 1 year of post-transplantation|Safety Sample|||Proportion of Participants|||Number
1292731|NCT00105196|Other Pre-specified|MADRS Remission|Number of subjects in remission. Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).|Baseline (Week 8) and Week 14||||participants|||Number
1292734|NCT00105196|Secondary|Mean Change in SDS Item Score (Work/School)|Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
1292735|NCT00105196|Secondary|Mean Change in SDS Item Score (Family Life)|Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
1292736|NCT00105196|Secondary|Mean Change in SDS Item Score (Social Life)|Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
1292737|NCT00105196|Secondary|Mean Change in Sheehan Disability Scale (SDS) Mean Score|Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
1292738|NCT00105196|Primary|Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)|Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
1292739|NCT00105183|Secondary|Pulmonary Function Test, Forced Expiratory Flow 25-75||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit|||Liters/second||Full Range|Median
1292740|NCT00105183|Secondary|Pulmonary Function Test, Forced Expiratory Volume in 1 Second||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit|||Liters||Full Range|Median
1292741|NCT00105183|Secondary|Pulmonary Function Test, Forced Vital Capacity||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit|||Liters||Full Range|Median
1292742|NCT00105183|Secondary|Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit|||Meters||Full Range|Median
1292743|NCT00105183|Secondary|Number of Participants With Severe Adverse Events||12 months|Safety population|||participants|||Number
1292744|NCT00105183|Secondary|Number of Participants With Infections and Infestations||12 months|Safety population|||participants|||Number
1292745|NCT00105183|Secondary|Number of Participants With Acute Rejection||12 months|ITT|||participants|||Number
1292746|NCT00105183|Secondary|Number of Participants With Death or Graft Loss Post-transplant||12 months|ITT population|||participants|||Number
1292747|NCT00105183|Primary|Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)||12 months|ITT. During the interim analysis the 5 mg/kg arm was dropped and it was showed that the study was insufficiently powered so the main focus of study shifted to safety endpoints. Data is based on local lung biopsy readings for efficacy failure instead of central readings|||participants|||Number
1292748|NCT00105157|Secondary|Number of Patients Discontinued With LAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292749|NCT00105157|Secondary|Number of Patients With Serious Drug-related LAEs at 168 Weeks|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292750|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 168 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292751|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292752|NCT00105157|Secondary|Number of Patients With Serious LAEs at 168 Weeks|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292753|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292756|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292757|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292758|NCT00105157|Secondary|Number of Patients That Died by 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292759|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 168 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292760|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 168 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292761|NCT00105157|Secondary|Number of Patients With Serious CAEs at 168 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292762|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
1292763|NCT00105157|Other Pre-specified|Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies|Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.|Baseline and Week 168|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
1292764|NCT00105157|Other Pre-specified|Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies|Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.|Baseline and Week 168|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1292765|NCT00105157|Post-Hoc|Number of Patients With Virologic Responses at Week 168 in Combined Substudies|Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 168; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 168.|168 weeks|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||Participants|||Number
1292766|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 96 Weeks||96 weeks|"All patients who took study medication and had~any laboratory tests performed were included in the analysis."|||Participants|||Number
1292767|NCT00105157|Secondary|Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks||96 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1292768|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 96 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|96 weeks||||Participants|||Number
1292769|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|96 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1292770|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292771|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292772|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292773|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292774|NCT00105157|Secondary|Number of Patients That Died by 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292775|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 96 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292776|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 96 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292777|NCT00105157|Secondary|Number of Patients With Serious CAEs at 96 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292778|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292779|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 48 Weeks||48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1292780|NCT00105157|Secondary|Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks||48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1292781|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 48 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1292782|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1292783|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292784|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292785|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292786|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292787|NCT00105157|Secondary|Number of Patients That Died by 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292788|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 48 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292789|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 48 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292790|NCT00105157|Secondary|Number of Patients With Serious CAEs at 48 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292791|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1292792|NCT00105157|Secondary|Change From Baseline in CD4 Cell Count at Week 24|Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)|Baseline and Week 24|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 Cell Count (cells/mm3) was carried forward for patients who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
1292793|NCT00105157|Secondary|Number of Patients With Virologic Responses at Week 24|Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24|24 weeks|All patients who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
1292975|NCT00102960|Secondary|Time to First Hospitalization|To compare time to first hospitalization in the three randomized arms (infants who received early ART in Arms 2 and 3 and those who received deferred ART in Arm 1). Not all participants were hospitalized and thus the upper limits could not be evaluated.|From randomization up to 4.8 years||||Weeks||Full Range|Median
1292794|NCT00105157|Primary|Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24|Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients|Baseline and Week 24|Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA <400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
1292795|NCT00105079|Secondary|Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters|Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported.|baseline and all study visits (Up to Week 52)|Safety population included all randomized patients who received at least one dose of study medication.|||participants|||Number
1292796|NCT00105079|Secondary|Number of Participants Assessed for Adverse Events (AEs)|Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.|reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)|Safety population included all randomized patients who received at least one dose of study medication|||participants|||Number
1292797|NCT00105079|Secondary|Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count|Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) – (CD4+ count at baseline).|Baseline to Week 48|ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.|||cells/mm^3||95% Confidence Interval|Median
1292798|NCT00105079|Secondary|Change From Baseline in HIV-1 RNA Viral Load|Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) – Log10 (HIV-1 RNA at baseline)|Baseline to Week 48|ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.|||copies/mL||95% Confidence Interval|Mean
1292799|NCT00105079|Secondary|Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL|"The secondary objectives of the study were to evaluate the safety, adherence, and tolerability of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL and the number of participants with HIV-1 RNA results <400 copies/mL are reported."|Week 48|Intent-to-Treat Population|||participants|||Number
1292800|NCT00105079|Primary|Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL|"The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported."|Week 48|intent-to-treat (ITT) Population|||participants|||Number
1292801|NCT00105066|Post-Hoc|Homa Insulin Sensitivity|Homeostatic Model Assessment of insulin sensitivity|4.5 months|Participants with complete data.|||HOMA Score||Standard Deviation|Mean
1292802|NCT00105066|Primary|Change in Flow Mediated Dilation (FMD)|to evaluate improvement in endothelial function|Baseline and 4.5 months|Participants with complete data.|||percentage change in diameter||Standard Deviation|Mean
1292803|NCT00105066|Primary|Change in Arterial Stiffness Compared to Baseline||Baseline and 4.5 months||||meters / second||Standard Deviation|Mean
1292804|NCT00105027|Secondary|Adverse Ocular Outcomes||12 months|Participants experiencing an adverse event|||events|||Number
1292805|NCT00105027|Secondary|Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography||12 months|Participants who attended month 12 visit|||um||Inter-Quartile Range|Median
1292806|NCT00105027|Secondary|Changes From Baseline in Best-corrected ETDRS Visual Acuity Score||12 months|Participants who attended month 12 visit|||letters read||95% Confidence Interval|Mean
1292807|NCT00105027|Primary|The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit|Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.|Change from baseline to 12 months||||Participants|||Number
1292808|NCT00105001|Secondary|Progression-free Survival|"Percentage of patients with progression-free survival, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|At 6 months and then every year thereafter, up to 5 years||||percentage of participants|||Number
1292809|NCT00105001|Secondary|Overall Survival|"Percentage of patients surviving, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|At 6 months and then every year thereafter, up to 5 years||||percentage of participants|||Number
1292810|NCT00105001|Secondary|Incidence of High-dose Corticosteroid Utilization.|"Percentage of patients utilizing high-dose corticosteroid (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|150 days after transplant||||percentage of participants|||Number
1292811|NCT00105001|Secondary|Incidence of Non-relapse Mortality|"Percentage of NRM as estimated by cumulative incidence methods with competing risks.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|200 days after transplant||||percentage of participants|||Number
1292812|NCT00105001|Primary|Incidence of Grades II-IV Acute GVHD|"Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|150 days after transplant||||percentage of participants|||Number
1292813|NCT00104884|Primary|Proportion of Patients With Response to Depsipeptide|"Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR).~Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits."|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years|The study was terminated early due to slow accrual with final accrual of 4 patients. There are no plans to conduct a formal analysis for any outcome measure.|||percentage of participants||95% Confidence Interval|Number
1292814|NCT00104871|Secondary|Progression-free Survival Assessed by RECIST|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|At 6 months|Two participants were not evaluable for response.|||Participants|||Count of Participants
1292815|NCT00104871|Primary|Participant Tumor Response Assessed by RECIST|Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))|Two participants were not evaluable for response.|||participants|||Number
1292816|NCT00104871|Primary|Objective Tumor Response Rate Assessed by RECIST|Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 12 weeks|Two participants were not evaluable for response.|||participants|||Number
1292817|NCT00104728|Secondary|Frequency of Toxicity Related to Study Treatment|Review of adverse events utilizing Common Toxicity Criteria (CTC) V3. To estimate the safety, tolerability, and feasibility of preoperative ZD1839 in patients with resectable Stage IA/IB, II and selected IIIA NSCLC by evaluating toxicity and operability after preoperative ZD1839.|3 years|||||||
1292818|NCT00104728|Primary|Overall Response Rate (ORR)|Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.|3 years|||||||
1292819|NCT00104650|Secondary|Hypercalcemia|Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria|Day 1, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Participants|||Number
1292820|NCT00104650|Secondary|Skeletal Related Events|Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1, week 25|All participants exposed to investigational product during the treatment phase.|||Participants|||Number
1292821|NCT00104650|Secondary|Time to First Skeletal Related Event|Time from study day 1 to first Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1, week 25|All participants exposed to investigational product during the treatment phase. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject who experienced a skeletal related event is presented.|||Participants|||Number
1292976|NCT00102960|Secondary|Duration of Hospitalisation|This is the total number of days spent in hospital by the participants and is reported per arm|4.8 years, the study duration||||Days|||Number
1292822|NCT00104650|Secondary|Percent Change of Serum CTX From Baseline to Week 25|Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.|Baseline, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx and had available data.|||Percent change||Standard Deviation|Mean
1292823|NCT00104650|Secondary|Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol|Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.|Day 1, week 25|Treatment Phase Primary Analysis Subset. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject whose uNTX (corrected by creatinine) less than 50nmol/mmol is presented.|||Participants|||Number
1292824|NCT00104650|Secondary|Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol|Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.|Day 1, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Days||Inter-Quartile Range|Median
1292825|NCT00104650|Secondary|Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25|Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.|Baseline, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Percent change||Standard Deviation|Mean
1292826|NCT00104650|Secondary|uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25|Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.|25 weeks|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Participants|||Number
1292827|NCT00104650|Primary|uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13|Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.|13 weeks|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Participants|||Number
1292828|NCT00104637|Secondary|O2 Saturation at Peak Exercise|O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.|Period 1 and Period 3 ( within 8 weeks)||||percentage of oxygen saturation||95% Confidence Interval|Least Squares Mean
1292829|NCT00104637|Secondary|Oxygen Pulse|Oxygen pulse during Cardiopulmonary exercise test at peak exercise.|Period 1 and Period 3 ( within 8 weeks)||||ml/beat||95% Confidence Interval|Least Squares Mean
1292830|NCT00104637|Secondary|A-a Gradient (Alveolar-arterial Gradient)|A-a gradient was measured with ABG breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)||||mm Hg||95% Confidence Interval|Least Squares Mean
1292831|NCT00104637|Secondary|Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)|Partial Pressure of Oxygen in ABG breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)||||mm Hg||95% Confidence Interval|Least Squares Mean
1292832|NCT00104637|Secondary|Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)|Partial pressure of carbon dioxide in ABG performed breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)||||mm Hg||95% Confidence Interval|Least Squares Mean
1292833|NCT00104637|Secondary|Diffusing Capacity of Carbon Monoxide (DLCO)|Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.|Period 1 and Period 3 ( within 8 weeks)||||ml/min/torr||95% Confidence Interval|Least Squares Mean
1292834|NCT00104637|Secondary|Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)|Participants were asked to scale the breathlessness felt at the end of 6MWT from 0 to 10, with 0 being the least discomfort and 10 being the most discomfort in breathing.|Period 1 and Period 3 ( within 8 weeks)||||Scores on a scale||95% Confidence Interval|Least Squares Mean
1292835|NCT00104637|Secondary|Forced Expiratory Volume in the First Second (FEV1 )|The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.|Period 1 ( 4 weeks)||||liters||95% Confidence Interval|Least Squares Mean
1292836|NCT00104637|Primary|VO2 Peak (Oxygen Consumption at Peak Exercise)|Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.|Period 1 and Period 3 ( within 8 weeks)||||ml/kg/min||95% Confidence Interval|Least Squares Mean
1292837|NCT00104637|Primary|6 Minute Walk Distance|The distance a subject walked within 6 minutes was measured and documented.|Period 1 and Period 3 ( within 8 weeks)||||meters||95% Confidence Interval|Least Squares Mean
1292838|NCT00104637|Secondary|Pulmonary Function FVC (Forced Vital Capacity)|Data to calculate results for FVC was based on Period 1.|Period 1 (4 weeks)||||liters||95% Confidence Interval|Least Squares Mean
1292839|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function|"rectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo.~Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point."|1 year||||cc||Standard Error|Mean
1292840|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism|"Primary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more.~Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point."|1 year||||score on a scale||Standard Error|Mean
1292841|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release|Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo|1 year||||ng/ml/8h||Standard Error|Mean
1292843|NCT00104520|Other Pre-specified|Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.|||μg/mL|||Number
1292844|NCT00104520|Other Pre-specified|Number of Participants With Other Pathogens|"Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans.~Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported."|Day 0 and Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.|||Participants|||Number
1292845|NCT00104520|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum|Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.|||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
1292846|NCT00104520|Secondary|Number of Hospitalization Days|Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF).|Day 0 to Day 84|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.|||Days||Standard Deviation|Mean
1292847|NCT00104520|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)|"Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines.~FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second.~The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group."|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Percent change in FEV1 (L)||Standard Error|Least Squares Mean
1292848|NCT00104520|Secondary|Change in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score|The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to tx who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to AE or study drug intolerance. For all other missing data, LOCF method was used.|||Units on a scale||Standard Error|Least Squares Mean
1292849|NCT00104520|Primary|Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics|The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.|Day 0 to Day 84 (end of study)|Analysis based on intents to treat (ITT) population (all participants randomized to treatment who received at least part of one dose of study drug).|||Days||95% Confidence Interval|Median
1292850|NCT00104416|Secondary|Serum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine|Serum samples for participants on lamotrigine were analyzed with a validated analytical method based on solid phase extraction of serum followed by High-Performance Liquid Chromatography (HPLC) Mass Spectrometry (MS)/MS analysis. The lower limit of quantification (LLQ) for serum lamotrigine was 4 nanograms (ng)/milliliter (mL), using a 50 microliter (µL) aliquot of human serum with a higher limit of quantification (HLQ) of 4,000 ng/mL. PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.|Blood samples drawn at Treatment Weeks 11, 15, and 19 (or last on-study measurement in Double-Blind Treatment Phase)|PK Population: Number of participants analyzed for PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.||||||
1292851|NCT00104416|Secondary|Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase|The ESS is an 8-item, self-administered questionnaire that measures excessive daytime sleepiness in adults. The instrument captures information on the extent to which the participant would be likely, or not, to fall asleep in certain situations. The stimulus question is: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? Questions are answered on a 4-point scale (would never doze [0] to high chance of dozing [3]). The total score ranges from 0 to 24, where a higher score indicates a higher chance of dozing.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 55 and 51 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
1292977|NCT00102960|Secondary|Hospitalization Rates|Hospitalisation rates in the three arms enrolled in the CHER study|4.8 years||||Events per 100 person years|||Number
1292852|NCT00104416|Secondary|Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase|The SSQ is a self-reported instrument developed to assess the severity of seizures and seizure symptoms. The scale consists of 10 major clinical features/symptoms of seizures that the participants rate on a 7-point Likert scale (ranging from very mild/helpful/no bother at all [1] to very severe/no help/bothersome [7]). The Global Bother Domain is the primary score used for the analysis of the SSQ and has scores ranging from 1 to 7.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 68 and 67 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
1292853|NCT00104416|Secondary|Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase|The AEP is a list of 19 items covering many possible side effects attributable to drug treatment. The participants respond by assessing how much each event has been a problem for them over the past 4 weeks (1=Never a Problem to 4=Always a Problem). Each individual item can be examined; an overall adverse events score is calculated as the sum of the scores across the 19 items. The AEP total score ranges from 19 to 76, with a higher score indicating a higher degree of adverse event severity.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 65 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
1292854|NCT00104416|Secondary|Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase|The QOLIE-31 is a 31-item questionnaire that evaluates the participants' perception of his or her quality of life in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, and overall quality of life. Each domain (with scores ranging from 0 to 100) is summed and divided by the total number of questions that were answered. The overall score is derived by weighting and then summing up the seven domain scores.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 55 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
1292855|NCT00104416|Secondary|Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase|The NDDI-E is a self-reported questionnaire composed of 46 brief phrases/words to identify mood disorders across the spectrum of depression. It was developed to capture depressive moods that are co-morbid with the disease of epilepsy or its treatment as well as to measure the depressive state of the participant. All phrases are measured on a 4-point Likert scale of Never (1) to Always/often (4) and refer to the participants’ mood over the past week. Scoring is comprised of a total mood score calculated by summing the scores of 6 specific items (from 6=never to 24=always or often).|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 65 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
1292856|NCT00104416|Secondary|Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase|The 20-item CES-D questionnaire is self-administered and asks respondents to report the frequency to which the 20 events were experienced over the past week. A 4-point Likert scale is used and ranges from rarely or none of the time (0) to most or all of the time (3). The total score, a sum across the 20 items (ranging from 0 to 60), determines the extent to which a participant may be experiencing depression. Higher scores indicate a higher severity of depression.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 64 and 59 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
1292857|NCT00104416|Secondary|Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase|The POMS is a self-administered 65-item questionnaire that evaluates the participants' perception of their mood state in 6 areas: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), with higher scores indicating a more negative mood state. A total score (from 0 to 24) is obtained by summing the scores of the six domains.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 53 and 57 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
1292858|NCT00104416|Secondary|Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.|Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire CP (CP Week 1 up to Week 52); the Transition Phase (CP Week 1 up to Week 7); the Open-Label (OL) Phase (CP Week 8 up to Week 52); and the last 8 weeks of the Open Label Phase (CP Week 45 up to Week 52) minus the seizure frequency at Baseline. W, Week.|Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)|ITT Population for CP. Variability in participant numbers are due to not having any PGTC seizures during the Baseline Phase and study withdrawal prior to progressing to the next phase.|||participants|||Number
1292893|NCT00103857|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.|||Percent||95% Confidence Interval|Least Squares Mean
1292859|NCT00104416|Secondary|Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase|Percent change from baseline is calculated as the number of seizures by week during the entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52) minus the number of seizures per week during the Baseline Phase (Baseline Week 1 through Week 8). A positive number equals a reduction in seizure frequency.|Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)|ITT Population for CP: all participants who took at least one dose of study medication during the CP and had at least one post baseline seizure assessment during the CP. Variability in participant numbers are due to not having any PGTC seizures during the Baseline Phase and study withdrawal prior to progressing to the next phase.|||percent change||Full Range|Median
1292860|NCT00104416|Secondary|Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase|Participants were asked to rate their satisfaction with their seizure control compared to their seizure control prior to initiating study drug on a 7 point scale: marked deterioration (1), moderate deterioration (2), mild deterioration (3), no change (4), mild improvement (5), moderate improvement (6), or marked improvement (7).|Week 19 (or last on-study assessment in Double-Blind Treatment Phase)|ITT Population. Participant satisfaction was not assessed for 2 participants in each of the Placebo and LTG XR groups, respectively.|||participants|||Number
1292861|NCT00104416|Secondary|Number of Participants With Improved Clinical Status on the Investigator’s Global Assessment in the Double-Blind Treatment Phase|The investigators rated the participants’ overall clinical status based on 7 clinical factors and an overall factor: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (marked deterioration [1], moderate deterioration [2], mild deterioration [3], no change [4], mild improvement [5], moderate improvement [6], or marked improvement [7]), the investigators assessed the participants’ status compared to their condition prior to initiating study medication.|Week 19 (or last on-study assessment in Double-Blind Treatment Phase)|ITT Population. Overall clinical status not assessed for 2 participants in each of the Placebo and LTG XR groups, respectively.|||participants|||Number
1292862|NCT00104416|Secondary|Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase|Change from baseline in body weight is calculated as the Week 19 (or last on-study measurement in Double-Blind Treatment Phase) value minus the Baseline value.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population|||kilograms||Full Range|Median
1292863|NCT00104416|Secondary|Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase|50% reduction in seizure frequency is defined as the time at which a participant first achieved and maintained a >=50% reduction in seizure frequency following exposure to at least 1 week of study drug.|Baseline through end of Double-Blind Treatment Phase (up to Week 19)|ITT Population|||participants|||Number
1292864|NCT00104416|Secondary|Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase|Percent change from baseline is calculated as the number of seizures by week during the Escalation Phase (Treatment Week 1 up to Week 7), the Maintenance Phase (Treatment Week 8 up to Week 19), and during the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency.|Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Week 12 up to Week 19)|ITT Population. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase as a result they were not counted for this efficacy endpoint; an additional 2 and 1 participants in the Placebo and LTG XR group, respectively, were not counted in the Maintenance Phase (MP) or last 8 weeks of MP due to study withdrawal.|||percent change||Full Range|Median
1292865|NCT00104416|Secondary|Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase|Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire DB Treatment Phase (Treatment Week 1 up to Week 19); the Escalation Phase (Treatment Week 1 up to Week 7); the Maintenance Phase (Treatment Week 8 up to Week 19); and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19), minus the seizure frequency at Baseline.|Entire DB Treatment Phase (Treatment Week 1 up to Week 19), Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19)|ITT Population. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase, as a result they were not counted in this efficacy endpoint; an additional 2 and 1 participants in the Placebo and LTG XR group, respectively, were not counted in the Maintenance Phase (MP) or last 8 weeks of MP due to study withdrawal.|||participants|||Number
1292866|NCT00104416|Primary|Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase|Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures.|Baseline through end of Double-Blind Treatment Phase (up to Week 19)|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment in the Double-Blind Treatment Phase. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase.|||percent change||Full Range|Median
1292961|NCT00103207|Secondary|Time to Progression by Smoking Status|Medians of time to progression by smoking status are reported.|Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline|Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.|||Months||95% Confidence Interval|Median
1292867|NCT00104299|Post-Hoc|Number of Subjects Experiencing Serious Adverse Events|Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.|Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)|Intent-to-treat|||participants|||Number
1292868|NCT00104299|Secondary|Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups|"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat|||Days||95% Confidence Interval|Number
1292869|NCT00104299|Secondary|Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups|"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat|||Days||95% Confidence Interval|Number
1292870|NCT00104299|Secondary|The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups|Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.|18 months post-randomization|Intent-to-treat|||Days||95% Confidence Interval|Number
1292871|NCT00104299|Secondary|The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups|"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat|||Days||95% Confidence Interval|Number
1292872|NCT00104299|Secondary|Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization|"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|6 months post-randomization|Safety Sample|||participants|||Number
1292873|NCT00104299|Secondary|Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy|The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident|Through common close-out (defined as 18 months after the last participant is enrolled in the trial)|Safety Sample|||participants|||Number
1292874|NCT00104299|Primary|Disease Remission|A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.|6 months post-randomization|Intent-to-treat (ITT) sample with worst case imputation|||Participants|||Number
1292875|NCT00104247|Primary|Change in Blood Phenylalanine Levels From Baseline to Week 6.||baseline to week 6||||micromole per liter||Standard Deviation|Mean
1292876|NCT00104234|Secondary|Change in Urinary Glycosaminoglycans (GAG) Level|Mean change in urinary GAG level for the first 72 weeks of rhASB treatment. For the rhASB/rhASB group, mean change was calculated for Week 72 -Baseline. For the placebo/rhASB, mean change was calculated for Week 96 - Week 24.|72 weeks|rhASB/rhASB and placebo/rhASB groups were combined for the analysis, representing 72 weeks of rhASB treatment in each group.|||microgram/mg creatinine||Standard Deviation|Mean
1292877|NCT00104234|Secondary|3-Minute Stair Climb|Mean change in number of stairs climbed per minute in 3 minutes. Mean change is the mean difference between the 3-Minute Stair Climb at 96 weeks and that measured before first ever treatment with rhASB. Mean change is calculated for Week 96 – Baseline for the rhASB/rhASB group and for Week 96 – Week 24 for the placebo/rhASB group.|Baseline ASB-03-05 through week 96 of ASB-03-06.|The efficacy analysis included all subjects who continued in the extension study (ASB-03-06) except 1 subject from the placebo/rhASB group who missed the Week 96 measurement.|||stairs/min||Standard Deviation|Mean
1292878|NCT00104234|Primary|12-Minute Walk Test|Mean change in meters walked in 12 minutes. Mean change is the mean difference between the 12-Minute Walk Test at 96 weeks and that measured before first ever treatment with rhASB. For the rhASB/rhASB group, mean change is calculated for Week 96 – Baseline. For the placebo/rhASB group, mean change is calculated for Week 96 – Week 24.|Baseline of ASB-03-05 through week 96 of ASB-03-06|The efficacy analysis included all subjects who continued in the extension study (ASB-03-06) except the 1 subject from the rhASB/rhASB group and 1 subject from the placebo/rhASB group who missed the Week 96 measurement.|||meters||Standard Deviation|Mean
1292880|NCT00104104|Secondary|Zoledronic Acid Concentrations|Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.|24 months|The pharmacokinetic (PK) population was analyzed for zoledronic acid concentration. Participants were considered to be in the PK population if they had evaluable PK data.|||ng/mL||Standard Deviation|Mean
1292881|NCT00104104|Secondary|Time to First Significant Increase in Serum Creatinine|Median time to event in participants who had a clinically relevant increase in serum creatinine.|Up to 24 months|Safety Population; enrolled patients who received at least one dose of study medication. The medians shown are only for patients who had a significant increase by 24 months.|||weeks||Full Range|Median
1292882|NCT00104104|Secondary|The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months|Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.|Baseline and 24 Months|Safety Population; enrolled patients who received at least one dose of study medication.|||Participants|||Number
1292883|NCT00104104|Primary|The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months|The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.|Baseline and 12 Months|Safety Population: enrolled patients who received at least one dose of study medication, exluding site 74.|||Participants|||Number
1292884|NCT00104052|Primary|Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment|SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment|Up to 48-week treatment duration. Follow-up of 24 weeks.|Carry Forward analysis of participants who received at least one dose of study medication. This dataset includes one subject with undetectable HCV-RNA at Follow-up Week 12 (FW 12) but missing data at FW 24; this subject was considered a sustained responder in the Carry Forward analysis.|||Participants|||Number
1292885|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.|||mg/dL||95% Confidence Interval|Least Squares Mean
1292886|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.|||mg/dL||95% Confidence Interval|Least Squares Mean
1292887|NCT00103857|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104|HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.|||Percent||95% Confidence Interval|Least Squares Mean
1292888|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
1292889|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
1292890|NCT00103857|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54|HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.|||Percent||95% Confidence Interval|Least Squares Mean
1292891|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.|||mg/dL||95% Confidence Interval|Least Squares Mean
1292892|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.|||mg/dL||95% Confidence Interval|Least Squares Mean
1292906|NCT00103844|Secondary|MCyR at Any Time Prior to Crossover|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (>0% to 35% Ph+ cells in metaphase in bone marrow).|Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.||||Participants|||Number
1292894|NCT00103844|Secondary|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib|Number of participants from which blood samples were collected for population PK studies.|Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose.|Blood samples that were to contribute to PK modeling were collected from 78 participants,to be included in separate population PK analyses. Although blood sample collection was listed as a secondary endpoint, no study-specific PK analyses were planned for this report.|||participants|||Number
1292895|NCT00103844|Secondary|Health-Related Quality of Life Prior to Crossover|Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.|Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date.|Since single-arm quality-of-life data are not interpretable in a non-comparative trial, these data were not analyzed.|||Units on a Scale|||Number
1292896|NCT00103844|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously from baseline through 2 years|All treated participants|||Participants|||Number
1292897|NCT00103844|Secondary|Cytogenetic Response After Crossover|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (>0% to 35% Ph+ cells in metaphase in bone marrow).|every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements|Participants evaluable for after crossover response|||Participants|||Number
1292898|NCT00103844|Secondary|CHR After Crossover|Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.|Participants evaluable for response after crossover|||Participants|||Number
1292899|NCT00103844|Secondary|Major Molecular Response (MMR)|Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.|Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.|Participants assessed for MMR only|||participants|||Number
1292900|NCT00103844|Secondary|Time to CHR Prior to Crossover|Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.|Number of participants achieving CHR in each treatment group|||weeks||Full Range|Median
1292901|NCT00103844|Secondary|Duration of Complete Hematologic Response (CHR)|Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|12 months, 24 months|Number of participants achieving CHR in each treatment group|||percentage of participants|||Number
1292902|NCT00103844|Secondary|Complete Hematologic Response (CHR) at Any Time Prior to Crossover|Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements.||||Participants|||Number
1292903|NCT00103844|Secondary|Time to MCyR Prior to Crossover|Median time from first dosing date to date of MCyR|Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.|Population consists of the number of responders in each treatment group|||months||Full Range|Median
1292904|NCT00103844|Secondary|Duration of MCyR at 24 Months|Percentage of participants who achieved MCyR and did not progress at 24 months.|24 Months|In the imatinib group, the 24 months timepoint was beyond the maximum observed time.|||Percentage of Participants|||Number
1292905|NCT00103844|Secondary|Duration of MCyR at 12 Months and 18 Months|Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.|12 months, 18 months||||percentage of participants.|||Number
1292907|NCT00103844|Primary|Number of Participants With Major Cytogenetic Response (MCyR) at Week 12|Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).|Week 12|All randomized subjects|||Participants|||Number
1292908|NCT00103740|Secondary|Number of Participants With a Disease Relapse During the Extended Observation Period|Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.|8 years was maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||participants|||Number
1292909|NCT00103740|Secondary|Number of Participants With a Partial Disease Relapse During the Extended Observation Period|Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||participants|||Number
1292910|NCT00103740|Secondary|Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period|Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||participants|||Number
1292911|NCT00103740|Secondary|Change in Pain Interference at Day 182|Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.|||units on a scale||Standard Deviation|Mean
1292912|NCT00103740|Secondary|Change in Pain Severity at Day 182|Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.|||units on a scale||Standard Deviation|Mean
1292913|NCT00103740|Secondary|Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28|Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years).|Day 28|Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.|||participants|||Number
1292914|NCT00103740|Secondary|Time to First Therapeutic Response|Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.|182 days|Intent-to-treat population: all randomized patients.|||days||Inter-Quartile Range|Median
1292915|NCT00103740|Secondary|Relative Change in Urine α-CTx in ug/mmol at Day 10|The percent change in urine α-CTx from baseline to Day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.|||percent change||Standard Deviation|Mean
1292916|NCT00103740|Secondary|Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10|The percent change in serum C-telopeptide from baseline to Day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.|||percent change||Standard Deviation|Mean
1292917|NCT00103740|Secondary|Relative Change in Serum Alkaline Phosphatase in U/L at Day 28|The percent change in serum alkaline phosphatase from baseline to Day 28 was measured.|Baseline and 28 days|Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.|||percent change||Standard Deviation|Mean
1292918|NCT00103740|Primary|Number of Patients Who Had Therapeutic Response at 6 Months|A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.|Baseline, 6 months|Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.|||participants|||Number
1292919|NCT00103662|Secondary|Graft Durability at 12 Months Post Transplantation|The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 13|Participants who received a stem cell transplant and were evaluable at 12 months post-transplant|||proportion of participants|||Number
1292920|NCT00103662|Secondary|Graft Durability at 6 Months Post Transplantation|The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 7|Participants who received a stem cell transplant and were evaluable at 6 months post-transplant|||proportion of participants|||Number
1292921|NCT00103662|Secondary|Graft Durability at 100 Days Post Transplantation|The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Day 138|Participants who received a stem cell transplant and were evaluable at 100 days post-transplant|||proportion of participants|||Number
1292922|NCT00103662|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.|Up to Month 13|Participants who received a stem cell transplant|||Days||Inter-Quartile Range|Median
1292923|NCT00103662|Secondary|Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment|The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.|Up to Month 13|Participants who received a stem cell transplant.|||Days||Inter-Quartile Range|Median
1292924|NCT00103662|Secondary|Median Number of Days to ≥6*10^6 CD34+ Cells/kg|The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.|up to Day 8|Intent-to-treat population|||Days||Inter-Quartile Range|Median
1292925|NCT00103662|Secondary|Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-Treat Population|||proportion of participants|||Number
1292926|NCT00103662|Secondary|Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-Treat Population|||proportion of participants|||Number
1292927|NCT00103662|Secondary|Number of Participants With Adverse Events|Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.|up to Day 38|Primary Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Four participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.|||participants|||Number
1292928|NCT00103662|Primary|Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.|up to Day 6|Intent-to-Treat Population|||proportion of participants|||Number
1292929|NCT00103610|Secondary|Graft Durability at 12 Months Post Transplantation|The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 13|Participants who received a stem cell transplant and were evaluable at 12 months post-transplant|||proportion of participants|||Number
1292930|NCT00103610|Secondary|Graft Durability at 6 Months Post Transplantation|The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 7|Participants who received a stem cell transplant and were evaluable at 6 months post-transplant|||proportion of participants|||Number
1292931|NCT00103610|Secondary|Graft Durability at 100 Days Post Transplantation|The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Day 138|Participants who received a stem cell transplant and were evaluable at 100 days post-transplant|||proportion of participants|||Number
1292932|NCT00103610|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13|Participants who received a stem cell transplant|||Days||Inter-Quartile Range|Median
1292933|NCT00103610|Secondary|Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment|The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13|Participants who received a stem cell transplant.|||Days||Inter-Quartile Range|Median
1292934|NCT00103610|Secondary|Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg|The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5*10^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.|up to Day 8|Intent-to-Treat Population.|||Days||Inter-Quartile Range|Median
1292935|NCT00103610|Secondary|Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis|Proportion of participants achieving a target of >=2*10^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-treat Population|||proportion of participants|||Number
1292936|NCT00103610|Secondary|Number of Participants With Adverse Events|Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.|up to Day 38|Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.|||participants|||Number
1292937|NCT00103610|Primary|Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis|Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant’s value was calculated as the sum of all daily values collected over the 4 apheresis days.|Days 5 to 8|Intent-to-Treat Population|||proportion of participants|||Number
1292938|NCT00103506|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)|Safety population included all the participants who received at least one dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1292939|NCT00103506|Secondary|Overall Survival|The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)||||months||95% Confidence Interval|Median
1292940|NCT00103506|Primary|Time to Progression (TTP)|Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.|Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006])|Intent-to-treat (ITT) included all the randomized participants.|||Months||95% Confidence Interval|Median
1292941|NCT00103376|Secondary|Disease-free Interval|This will only be analyzed if sample size warrants the analysis.|3 months after combined treatment|data was not collected for this outcome measure.||||||
1292942|NCT00103376|Secondary|Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0||From start of treatment until end of study, up to 6 months||||participants|||Number
1292943|NCT00103376|Primary|Time to PSA Progression|PSA progression is defined as a PSA increase of 50% over the nadir CR or CR/PR value on three successive PSA measurements two months apart to a value of >= 1.0 ng/ml.|From on study until time of PSA progression for up to two years|Only patients with a CR were included in the analysis. No patients in Part A had a complete response. Time to progression for Part B only and Part A+Part B was calculated together. The information for the confidence interval is not available.|||months||95% Confidence Interval|Median
1292944|NCT00103376|Primary|Prostate-specific Antigen (PSA) Response||3 months after the start of treatment||||participants|||Number
1292945|NCT00103311|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier by arm.|From the date of registration to the date of death, assessed up to 12 months||||months||95% Confidence Interval|Median
1292946|NCT00103311|Secondary|Progression-free Survival|Will be estimated using the product-limit method of Kaplan and Meier by arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of registration to the date of documented PSA progression, assessed up to 6 months||||weeks||95% Confidence Interval|Median
1292947|NCT00103311|Primary|Objective Response (CR or PR) as Determined by the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years||||participants|||Number
1292948|NCT00103285|Secondary|Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)|Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|6 years|Patients on the two arms being compared got similar therapy. All patients included in this analysis are MRD negative. SR-Average patients who were CNS2 at diagnosis were excluded in order to have comparable patient cohorts. SR-Low patients are TEL/Trisomy positive while SR-Average patients are TEL/Trisomy negative.|||Percent probability||95% Confidence Interval|Number
1292949|NCT00103285|Secondary|Event-free Survival (EFS) for SR-High Patients.|Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|6 years|CCR: Complete Continuous Remission, where time to event is defined as the time from start of consolidation therapy to first event or date of last follow up for those who did not experience an event. All patients enrolled on the SR-High were used in this analysis regardless of completion of therapy.|||percent probability||95% Confidence Interval|Number
1292950|NCT00103285|Secondary|Optimal Time Point for Advance Health Related Quality of Life Intervention|Percentage of patients with elevated Anxiety.|At 1 month after diagnosis and 3 months post-therapy.|Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy.|||Percentage of participants||95% Confidence Interval|Number
1292951|NCT00103285|Secondary|Early Marrow Status (EMS) by MRD Status End Induction (Day 29)|Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)|Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.|Patients who had MRD day 29 data but their Bone Marrow (BM) days 8/15 data were missing are excluded. This analysis was done with patients who had both MRD and BM data. There were 5 patients excluded in both MRD Negative and MRD Positive groups due to missing days 8/15 BM.|||Participants|||Count of Participants
1292952|NCT00103285|Secondary|Overall Survival Probability (OS) According to Induction Day 29 MRD Status|Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive.|Overall Survival Probability of 6 years|4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29.|||percent probability||95% Confidence Interval|Number
1292953|NCT00103285|Secondary|Event-Free Survival Probability According to MRD Status End Induction (Day 29)|Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|MRD at Day 29 of therapy|4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29|||Percent Probability||95% Confidence Interval|Number
1292954|NCT00103285|Secondary|Health-related Quality of Life Relative to Physical, Social and Emotional Impairment|To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.|At 1, 6 and 12 months after diagnosis and, 3 months post-therapy|This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).|||Percentage of participants||95% Confidence Interval|Number
1292955|NCT00103285|Primary|Event-free Survival (EFS) for SR-Low Patients|Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|6 years|Only eligible patients are included in the analysis.|||Percent probability||95% Confidence Interval|Number
1292956|NCT00103285|Primary|Event-free Survival (EFS) for SR-Average ALL Patients|EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|6 years|Only eligible patients are included in this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual.|||percent probability||95% Confidence Interval|Number
1292957|NCT00103259|Secondary|Overall Survival on Step 1|Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.|Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 years|61 eligible and treated patients were included in the analysis|||months||95% Confidence Interval|Median
1292958|NCT00103259|Secondary|Progression-free Survival on Step 1|Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.|Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry|61 eligible and treated patients were included in the analysis|||months||95% Confidence Interval|Median
1292959|NCT00103259|Secondary|Response Rate on Step 2|Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 years|10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis|||percentage of participants||90% Confidence Interval|Number
1292960|NCT00103259|Primary|Response Rate on Step 1|Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years|61 eligible and treated patients were included in the analysis|||percentage of participants||90% Confidence Interval|Number
1292962|NCT00103207|Secondary|Overall Survival by Smoking Status|Medians of overall survival by smoking status are reported.|Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline|Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.|||Months||95% Confidence Interval|Median
1292963|NCT00103207|Secondary|Time to Progression|Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included in the analysis.|||Months||95% Confidence Interval|Median
1292964|NCT00103207|Secondary|Overall Survival|Overall survival is defined as the time from registration to death.|Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included.|||Months||95% Confidence Interval|Median
1292965|NCT00103207|Primary|Objective Response Rate (Proportion of Patients With Objective Response)|Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included in this analysis.|||Proportion||90% Confidence Interval|Number
1292966|NCT00103194|Secondary|Relationship Between Progression-free Survival and EGFR Expression Levels|The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started treatment.|||months||90% Confidence Interval|Median
1292967|NCT00103194|Secondary|Progression-free Survival Rate at 2 Years|Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started treatment.|||percentage of participants||90% Confidence Interval|Number
1292968|NCT00103194|Secondary|The Change in PSA Slope With GW572016 (Lapatinib)|PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years|One patient who withdrew from study after receiving 4 days of treatment and did not have any follow-up PSA measurements was excluded from this analysis, so the number of participants analyzed is 34.|||log (PSA)/month||Standard Error|Mean
1292969|NCT00103194|Primary|Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level|"PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period.~CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response.~PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started protocol treatment|||participants|||Number
1292970|NCT00103142|Secondary|Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay|CEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.|13 weeks||||participants|||Number
1292971|NCT00103142|Primary|Recurrence-free Survival at 2 Years|Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.|2 years||||participants|||Number
1292972|NCT00103116|Secondary|Number of Participants Alive Five Years Post Vaccine|Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine|five years post vaccine||||participants|||Number
1292973|NCT00103116|Primary|Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization|Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.|six months post vaccine||||participants with immunological response|||Number
1292974|NCT00103012|Primary|Lopinavir Pharmacokinetics When Administered Alone and in Combination With Three Different Herbal Supplements: Ginkgo Biloba, Panax Ginsing, and Echinacea Purpurea.|The outcome measurement for each study arm is the change in lopinavir area under the concentration versus time curve (AUC) after two weeks administration of an herbal preparation (Ginkgo Biloba, Echinacea purpurea, or Panax Ginseng).|2 weeks|Data was analyzed from all subjects who completed a particular sampling period.|||mcg*hr/mL||90% Confidence Interval|Geometric Mean
1292978|NCT00102960|Secondary|Time to Death Alone or Death Plus Life Threatening Stage C Events or HIV Events Associated With Permanent End-organ Damage.|This was a composite endpoint in which the number of children experiencing the events is reported. The number of participants experiencing the events did not reach the 50% survival and thus median time-to-event is not be presented. Therefore, we report the number of participants experiencing the events per Arm.|4.8 years||||Participants|||Count of Participants
1292979|NCT00102960|Secondary|Number of Participants With Indicated Viral Resistance Mutations at the Time of Failure of First Line Therapy|Resistance testing was performed on samples with a VL≥1000 c/ml together with the matched baseline sample, if available. Reverse transcriptase (NRTI and NNRTI) and protease (PI) inhibitor mutations were analysed using a validated in-house population-based sequencing assay and the IAS 2011 mutation list.|4.8 years|Mutations presented descriptively were 1) Protease inhibitor mutations and 2) Met184Val mutations were reported. Only 32 participants with viral load above 1,000 copies/ml at their last visit while on treatment were analysed.|||Participants|||Count of Participants
1292980|NCT00102960|Secondary|Time From Randomization to Starting or Needing to Start Continuous Therapy|Time from randomization to starting (deferred therapy Arm) or needing to start continuous therapy (early therapy 40 or 96 weeks)|4.8 years||||Weeks||Full Range|Median
1292981|NCT00102960|Secondary|Total Occurrence of Grade 3 or 4 Laboratory Events||From randomization up to 4.8 years||||Count of events|||Number
1292982|NCT00102960|Secondary|Total Occurrence of Grade 3 or 4 Clinical Events|This was a secondary outcome measure that assessed the total count of Grade 3 or 4 (clinical or laboratory) adverse events.|4.8 years|This analysis was only performed on the primary groups including a total of 377 participants|||Count of events|||Number
1292983|NCT00102960|Secondary|Number of Children Experiencing Severe CDC Stage B or Stage C Disease or Death (Cumulative After 3.5 Years)|The outcome measure is defined as a number because it represents the number of children that experienced severe CDC Stage B or Stage C disease or death as defined in the outcome measure title above|Occurrence of severe CDC Stage B or Stage C disease or death (cumulative after 3.5 years), whichever came first, was assessed from randomization up to at least 3.5 years.||||Participants|||Count of Participants
1292984|NCT00102960|Primary|Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart)|This was part of the primary outcome measure that was a composite endpoint that included confirmed HIV-1 RNA value of at least 10,000 copies per/ml recorded on two consecutive separate occasions after 24 weeks of treatment (initial therapy or restart).|Virological failure was assessed from randomization through the entire study duration of 4.8 years.||||Participants|||Count of Participants
1292985|NCT00102960|Primary|Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy.|This included development of severe CDC Stage B or Stage C disease.This was part of the primary outcome measure that was a composite endpoint|Clinical failure on therapy was assessed at each visit for the entire study duration of 4.8 years.||||Participants|||Count of Participants
1292986|NCT00102960|Primary|Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity|Development of toxicity requiring more than one drug substitution within the same class or a switch to a new class of drugs (regimen-limiting toxicity failure) or requiring a permanent treatment discontinuation. This was part of the primary outcome measure that was a composite endpoint.|Regimen limiting drug toxicity was monitored from randomization up to the entire study duration of 4.8 years.||||Participants|||Count of Participants
1292987|NCT00102960|Primary|Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart)|This was part of the primary outcome measure above. The primary outcome was a composite endpoint. The primary outcome analysis only considered the initially enrolled children that were 377 in total (ART-Deferred n=125, Early therapy 40 weeks n=126 and Early therapy 96 weeks n=126). This was part of the primary outcome measure that was a composite endpoint.|This outcome was assessed from the date of randomization to immunological failure. Immunological failure was assessed in the entire study duration of 4.8 years.||||Participants|||Count of Participants
1292988|NCT00102960|Primary|Time to Failure of First Line Therapy or Death|To compare time to failure of first line ART (due to clinical, virological or immunological disease progression, or regimen-limiting ART toxicities) or death among three randomized arms (infants who receive early ART in Arms 2 and 3 and infants in whom ART is deferred until clinical or immunological disease progression in Arm 1) during the study (up to 4.8 years). The number of participants experiencing the events did not reach the 50% survival and thus median time-to-event is not be presented. Therefore we report the number of participants experiencing the events per Arm.|From date of randomization up to failure of first-line therapy or death from any cause, whichever came first, assessed up to 4.8 years|In the analysis of failure of first-line therapy, children enrolled in the ART-Deferred group were used as the reference category in the hazard ratio analysis.|||Participants|||Count of Participants
1292989|NCT00102804|Secondary|Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS|The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.|Baseline through 30 days post discontinuation of study treatment (up to 39 Months)|Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.|||units on a scale||Standard Deviation|Mean
1292990|NCT00102804|Secondary|Number of Participants With Adverse Events (AEs)|Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 41 Months)|Participants who signed the ICF, completed the randomized process and received at least 1 dose of study drug are reported according to the treatment to which they were received.|||participants|||Number
1292991|NCT00102804|Secondary|Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)|Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)*100.|Baseline to measured PD (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1292992|NCT00102804|Secondary|Time to Worsening of Symptoms (TWS)|TWS was the elapsed time from the date of randomization to the first date of worsening [defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.|Randomization to worsening of each LCSS item (up to 39 months)|Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.|||months||95% Confidence Interval|Median
1292993|NCT00102804|Secondary|Time to Objective Progressive Disease (TPD)|TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant’s last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization to measured PD (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 145, 40 participants in the pemetrexed and placebo treatment arms, respectively.|||months||95% Confidence Interval|Median
1292994|NCT00102804|Secondary|Overall Survival (OS) Time|OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.|Randomization to date of death from any cause (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 138, 48 participants in the pemetrexed and placebo treatment arms, respectively.|||months||95% Confidence Interval|Median
1292995|NCT00102804|Primary|Progression-Free Survival (PFS) Time|PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant’s last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization to measured PD or death from any cause (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 123, 36 participants in the pemetrexed and placebo treatment arms, respectively.|||months||95% Confidence Interval|Median
1292996|NCT00102687|Secondary|Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period|Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Maintenance study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).|24 months|Intent to treat population|||infections per cycle||Full Range|Median
1292997|NCT00102687|Secondary|Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period|Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Initial study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).|6 months|Intent to treat population|||infections per cycle||Full Range|Median
1292998|NCT00102687|Secondary|Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)|Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.|24 months|Intent to treat population|||participants|||Number
1292999|NCT00102687|Secondary|Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)|Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.|24 months|Intent to treat population|||participants|||Number
1293000|NCT00102687|Secondary|Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)|Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.|6 months|Intent to treat population|||participants|||Number
1293001|NCT00102687|Secondary|Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)|Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.|6 months|Intent to treat population|||participants|||Number
1293002|NCT00102687|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)|The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.|24 months|Intent to treat population|||x10^9/L||Full Range|Median
1293003|NCT00102687|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)|The difference between ANC values at the end of the initial study period minus the ANC values at baseline.|6 months|Intent to treat population|||x10^9/L||Full Range|Median
1293004|NCT00102687|Secondary|Baseline Absolute Neutrophil Count (ANC) Values|The median values for ANC based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for ANC. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population|||x10^9/L||Full Range|Median
1293005|NCT00102687|Secondary|Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)|The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.|24 months|Intent to treat population|||x10^9/L||Full Range|Median
1293006|NCT00102687|Secondary|Change From Baseline in Platelets at the End of Initial Study Period (6 Months)|The difference between platelet values at the end of the initial study period minus the platelet values at baseline.|6 months|Intent to treat population|||x10^9/L||Full Range|Median
1293007|NCT00102687|Secondary|Baseline Platelet Values|The median values for platelets based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for platelets. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population|||x10(9)/L||Full Range|Median
1293008|NCT00102687|Secondary|Change From Baseline in Hemoglobin at the End of the Maintenance Study Period|The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.|24 months|Intent to treat population|||g/L||Full Range|Median
1293009|NCT00102687|Primary|Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period|Hematologic response during the maintenance period are compared to the response in the initial study period. Initial response could have been a complete remission, a partial remission, stable disease or a hematologic improvement. Maintenance period best response is after randomization to a maintenance arm for those randomized, and is after the start of cycle 7 for those remaining on initial period treatment throughout the study.|24 months|Intent to treat population.|||participants|||Number
1293010|NCT00102687|Secondary|Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)|The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.|6 months|Intent to treat population|||g/L||Full Range|Median
1293011|NCT00102687|Secondary|Baseline Hemoglobin Values|The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population|||g/L||Full Range|Median
1293012|NCT00102687|Primary|Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period|Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.|Day 1 (randomization) to 6 months|Intent to treat population|||participants|||Number
1293013|NCT00102687|Primary|Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.|"IWG 2000 Criteria: Pretreatment=hemoglobin <110g/L or RBC transfusion-dependence, platelet count <100x10^9/L or platelet transfusion dependence, absolute neutrophil count <1.5x10^9/L.~Erythroid response: Major->20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or >=50% decrease in transfusion requirements.~Platelet response: Major-absolute increase of platelet count by >=30x10^9/L or platelet transfusion independence. Minor->=50% increase in platelet count with net increase >10x10^9/L but <30x10^9/L.~(continued in Population Description)"|Day 1 (randomization) to 6 months|"Intent to treat population. Patients count only once for best response within an improvement category.~(Outcome Description continued) Neutrophil response: Major->=100% increase in neutrophil count or an absolute increase of >0.5x10^9/L. Minor->=100% increase but an absolute increase of <0.5x10^9/L."|||participants|||Number
1293014|NCT00102687|Primary|Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.|"Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD).~Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)"|Day 1 (randomization) to 6 months|"Intent to treat population. Patients without a second bone marrow assessment could not be evaluated for hematologic response.~(Outcome Description continued)SD is a failure to achieve at least a PR, but with no evidence of progression for at least 2 months."|||participants|||Number
1293015|NCT00102596|Secondary|PR and QTc Intervals Post 1-Octanol Dose||0 minutes, 15 minutes, 100 minutes and 24 hours post-dose|All participants who received at least 1 dose of 1-octanol in Part A, B or C|||ms||Standard Error|Least Squares Mean
1293016|NCT00102596|Secondary|Heart Rate Post 1-Octanol Dose||0 minutes, 15 minutes, 100 minutes and 24 hours post-dose|All participants who received at least 1 dose of 1-octanol in Part A, B or C|||beats per minute||Standard Error|Least Squares Mean
1293017|NCT00102596|Secondary|Blood Plasma Levels of Octanoic Acid After 64 mg/kg 1-Octanol Dose|Octanoic Acid is a metabolite of 1-octanol. Blood plasma levels of octanoic acid were measured at 5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose.|5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose|All participants who received either formulation 64 mg/kg 1-octanol in Part A or B|||ng/ml||Standard Deviation|Mean
1293018|NCT00102596|Primary|Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B|Spirography mean tremor amplitudes were measured in the right hand of each participant at 0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose. Then, the scores of each participant were normalized (i.e., divided by) by their baseline tremor severity scores so that all scores are expressed as a proportion of the baseline score. Therefore, 1 is the baseline tremor severity, and lower scores indicate tremor reduction.|0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose|All participants who received both formulations of 64 mg/kg 1-octanol in Part B|||normalized score on a scale||Standard Error|Mean
1293019|NCT00102531|Primary|The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.||4 to 48 weeks||||participants|||Number
1293020|NCT00102518|Secondary|Change in Young Mania Rating Scale (Y-MRS) Total Score|"Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 26||||points||Standard Deviation|Mean
1293021|NCT00102518|Secondary|Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).~This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome."|Baseline and Week 26||||points||Standard Deviation|Mean
1293022|NCT00102518|Primary|Percentage of Subjects Experiencing SAEs|Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.|Baseline and Week 23|All enrolled subjects.|||percentage of participants|||Number
1293023|NCT00102440|Secondary|Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.|The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.|Weeks 8 through 52|Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 52.|||percentage of subjects|||Number
1293024|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.|Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
1293025|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.|The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
1293026|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.|The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
1293027|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
1293028|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
1293042|NCT00102063|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score|"Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward.~Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome."|Baseline and Day 42||||points||Standard Error|Mean
1293029|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
1293030|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Final Visit|The percent change in serum urate from baseline to the Final visit was calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||percent change from baseline||Standard Deviation|Mean
1293031|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 52.|Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||percent change from baseline||Standard Deviation|Mean
1293032|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 28.|Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||percent change from baseline||Standard Deviation|Mean
1293033|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.|Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
1293034|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit|Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized.|Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
1293035|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit|Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.|Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
1293036|NCT00102440|Primary|Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)|Each subject’s serum urate at the last 3 visits determined the subject’s response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.|Last 3 Visits (up to 52 weeks)|Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL.|||Percentage of subjects|||Number
1293037|NCT00102063|Other Pre-specified|Patients Achieving Remission|The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score.|Baseline and Day 42||||participants|||Number
1293038|NCT00102063|Other Pre-specified|Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score|"Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward.~Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome)."|Baseline and Day 42||||points||Standard Error|Mean
1293039|NCT00102063|Secondary|Change in Children’s Global Assessment Scale (CGAS) Score|"Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward.~Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Day 42||||points||Standard Error|Mean
1293040|NCT00102063|Secondary|Clinical Global Impression (CGI) Improvement Score|"Last observed post-baseline value in CGI improvement score, using the last observation carried forward.~Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)."|Baseline and Day 42||||points||Standard Error|Mean
1293041|NCT00102063|Secondary|Change in Clinical Global Impression (CGI) Severity Score|"Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward.~Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)."|Baseline and Day 42||||points||Standard Error|Mean
1293043|NCT00102063|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score|"Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward.~Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome."|Baseline and Day 42||||points||Standard Error|Mean
1293044|NCT00102063|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward.~This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome."|Baseline and Day 42||||points||Standard Error|Mean
1293045|NCT00101933|Other Pre-specified|Change in Most Severe Seizures|"Seizures were recorded on daily seizure diaries. The subject recorded the number of seizures by seizure type on the seizure diary. The subject also noted at baseline, of those they had ever experienced, which seizure they considered to be most severe."|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set. In addition, the protocol prespecified that if a subject did not experience the severe seizure in the baseline phase that they would not be included in the calculation of the blinded phase median seizure frequency percentage change from baseline."|||Percentage change from baseline||Inter-Quartile Range|Median
1293046|NCT00101933|Primary|Alternative Primary Analysis: Change in Seizure Rate|A generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. With one outlier subject removed, the GEE model for this alternative analysis included treatment effect, log of the baseline seizure count, log of age, visit (categorical), and the offset (the number of days the diary was recorded in each month).|Through the end of the three-month blinded phase|"This analysis used the protocol-prespecified Primary analysis data set with one additional outlier subject removed from the active group. This subject had 210 stimulation initiated seizures within 48 hours of the device being turned on and was determined to be an outlier using both a statistical and clinical rationale."|||Percentage change from baseline||Inter-Quartile Range|Median
1293047|NCT00101933|Secondary|Proportion of Treatment Failures|A treatment failure was defined in the protocol as a subject who 1) required 3 or more doses of rescue medication within 48 hours, 3 times during the blinded phase; or 2) had 3 episodes of convulsive status epilepticus during the blinded phase.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."|||participants|||Number
1293048|NCT00101933|Secondary|Percentage Change in the Maximum Length of Seizure-free Intervals|Difference between active group and control group in percentage change in the maximum length of seizure-free intervals over the entire blinded phase as compared to the entire baseline phase.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."|||Percentage change from baseline||Inter-Quartile Range|Median
1293049|NCT00101933|Secondary|Change in Percentage of Days Seizure-free|Difference between active group and control group in percentage change in seizure-free days over the entire blinded phase as compared to the entire baseline phase. The number of seizure-free days was normalized to 84-day baseline and blinded phases for each subject.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. In addition, percentage change was not calculated for subjects who had no seizure-free days during the baseline phase."|||Percentage change from baseline||Inter-Quartile Range|Median
1293050|NCT00101933|Secondary|Seizure Responder Rate|A responder is defined as a subject with greater than or equal to 50% reduction in seizures as compared with baseline.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."|||Number of participants|||Number
1293051|NCT00101933|Secondary|Incidence of Sudden Unexplained Death in Epilepsy (SUDEP)|"The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP classifications were included in the calculation.~The results shown are for the entire study follow-up after device implantation."|Inclusive of all study follow-up after device implantation (mean follow-up 3.7 years)|This analysis used all subjects who were implanted and received stimulation. One subject was implanted but was not subsequently randomized, but did receive stimulation. This subject has been included for the purposes of this analysis for a total of 110 subjects included in this analysis.|||Number of subjects experiencing SUDEP|||Number
1293052|NCT00101933|Secondary|Adverse Events Experienced With the Medtronic DBS System|"The results are for the follow-up after device implantation through Year 2 and summarized are events that occurred in greater than 5% of subjects. Only events related to the device, therapy, or surgery are included. These abbreviations were used:~General dis...=General disorders and administration site conditions~Injury, poison...=Injury, poisoning and procedural complications~Ther.=Therapeutic.~For this summary, adverse events are reported as 'MedDRA System Organ Class - adverse event'."|Through Year 2 of the long-term follow-up phase|This analysis used all subjects who were implanted and received stimulation. One subject was implanted but was not subsequently randomized, but did receive stimulation. This subject has been included for the purposes of this analysis for a total of 110 subjects, as opposed to the 109 stated in the participant flow.|||participants|||Number
1293105|NCT00101686|Primary|Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|Intent-to-Treat Population (ITT) - all subjects who were randomized, with study drug assignment designated according to initial randomization, regardless of whether subjects received any study drug or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1293053|NCT00101933|Primary|Primary Analysis: Change in Seizure Rate|A protocol-prespecified generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. The final GEE model for the primary objective evaluation included treatment effect, log of the baseline seizure count, log of age, visit (categorical), treatment-by-visit interaction (categorical), and the offset (the number of days the diary was recorded in each month).|Through the end of the three-month blinded phase|"This analysis used the protocol-prespecified Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."|||Percentage change from baseline||Inter-Quartile Range|Median
1293054|NCT00101907|Primary|Participant Incidence of Adverse Events|The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting.|From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.|Safety Analysis Set, composed of all participants in the AMG 706 treatment groups who received at least one dose of AMG 706 and all participants in the panitumumab-only treatment group who received at least one dose of panitumumab.|||Participants|||Number
1293055|NCT00101907|Secondary|AUC0-inf|Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort.|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK analysis set. Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.|||μg*hr/mL||Standard Deviation|Mean
1293056|NCT00101907|Secondary|AUC0-24|Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method.|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK Analysis set; Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.|||μg*hr/mL||Standard Deviation|Mean
1293057|NCT00101907|Secondary|Cmax|The maximum observed plasma concentration after AMG 706 dosing|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK analysis set.|||ng/mL||Standard Deviation|Mean
1293058|NCT00101907|Secondary|Tmax|Time after dosing when maximum plasma concentration was observed for AMG 706|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|The Pharmacokinetic (PK) Analysis Set consists of patients who had dosing and PK sampling times recorded on the day of PK sample collection and no significant protocol deviations that impacted the quality of the PK data (for example, sample processing errors and/or inaccurate dosing on the day of the PK sampling).|||hours||Full Range|Median
1293059|NCT00101907|Secondary|Number of Participants With an Objective Tumor Response|The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR.|From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.|Efficacy Analysis Set, defined as defined as patients who received at least 1 dose of AMG 706 for AMG 706 treatment groups and patients who received at least 1 dose of panitumumab for the panitumumab-only treatment group.|||participants|||Number
1293060|NCT00101868|Secondary|Physician Time Spent to Complete the Discharge Application||averaged over 2 years of patient enrollment|||||||
1293061|NCT00101868|Secondary|Number of Emergency Department Visits|Number of participants with at least one emergency department visit within six months after discharge|within 6 months after discharge|intention to treat|||participants|||Number
1293062|NCT00101868|Secondary|Number of Outpatient Visits||within 6 months after discharge|||||||
1293063|NCT00101868|Secondary|Discharge Physician Satisfaction With Discharge Process||6 months after using discharge process|||||||
1293064|NCT00101868|Secondary|Primary Care Physician's Perception, Satisfaction||10 days after discharge|||||||
1293065|NCT00101868|Secondary|Primary Care Physician's Perception, Effectiveness||10 days after discharge|||||||
1293066|NCT00101868|Secondary|Patient's Satisfaction With Drug Information||1 week after discharge|||||||
1293067|NCT00101868|Secondary|At Least One Adverse Event Within One Month After Discharge|Number of participants with at least one adverse event within one month after discharge|1 month after discharge|intention to treat|||participants|||Number
1293068|NCT00101868|Secondary|Pharmacist's Satisfaction With Discharge Prescription||1 day after discharge|||||||
1293069|NCT00101868|Secondary|Pharmacist Needed to Clarify the Discharge Prescription||1 day after discharge|||||||
1293070|NCT00101868|Secondary|Patients' Perception of Discharge Process, Satisfaction||1 week after discharge|||||||
1293071|NCT00101868|Secondary|Patients' Perception of Discharge Process, Effectiveness, Satisfaction, Preparedness||1 week after discharge|||||||
1293072|NCT00101868|Primary|Hospital Readmission, at Least One|Number of participants with at least one readmission within 6 months after discharge from index hospital visit|within 6 months after discharge|Analysis was intention to treat. All 631 patient participants assigned to interventions were analyzed|||participants|||Number
1293073|NCT00101816|Secondary|Population PK of Dasatinib|Population pharmacokinetic analysis was not done because it is not meaningful for this single study|Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.||||population pk|||Number
1293074|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
1293075|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
1293076|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h (AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng∙h/mL||Standard Deviation|Mean
1293077|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng/mL||Standard Deviation|Mean
1293078|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
1293079|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
1293080|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were < lower limit of qualtitation were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng∙h/mL||Standard Deviation|Mean
1293081|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng/mL||Standard Deviation|Mean
1293106|NCT00101660|Secondary|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib|Blood samples were collected for PK to be included in separate population PK analyses.|Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.|No study-specific PK analyses were planned for this report.|||Participants|||Number
1293082|NCT00101816|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period|All treated subjects|||Participants|||Number
1293083|NCT00101816|Secondary|Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Score range: 0-108; higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.|Baseline, Every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up|Number of participants with FACT-G assessments at baseline and at least one assessment during treatment|||Participants|||Number
1293084|NCT00101816|Secondary|MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations|MaHR and MCyR in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). Criteria for MaHR are specified in Outcome Measure 2. MCyR=rate of complete cytogenetic responses + the rate of partial cytogenetic responses, as defined in Outcome Measure 5. BCR-ABL=the fused gene found in subjects with this type of CML. This table contains those mutations observed in at least 3 participants. The categories “1 IRM w/2-4-fold increase in resistance” and “≥1 IRM w/≥5-fold increase in resistance” refer to increase in resistance to imatinib.|baseline, at time of disease progression|All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 103 of the 109 subjects (10/10 imatinib-intolerant and 93/99 imatinib-resistant). At baseline, 39 (42%) imatinib-resistant subjects and 3 imatinib-intolerant subject had imatinib-resistant mutations|||Percentage of Participants|||Number
1293085|NCT00101816|Secondary|Number of Participants Achieving Major Molecular Response (MMR)|Number of participants who achieved an MMR at any time during the treatment period. MMR was calulated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).|Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis|treated participants with or without CCyR who were assessed for major molecular response|||participants|||Number
1293086|NCT00101816|Secondary|Number of Participants With CHR or NEL, MiHR, or no Hematologic Response|Best confirmed hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for complete hematologic response (CHR) or No Evidence of Leukemia (NEL) are specified in Outcome Measure 2. Criteria for minor hematologic response (MiHR) are specified in Outcome Measure 1.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment|All treated subjects|||Participants|||Number
1293087|NCT00101816|Secondary|Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response|Best confirmed cytogenetic response. Determination of cytogenetic response is based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).|Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment|All treated subjects|||Participants|||Number
1293088|NCT00101816|Secondary|Time to MaHR and OHR|Median time from first dosing to date of OHR and/or MaHR in subjects who achieved OHR and MaHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved OHR and MaHR|||days||95% Confidence Interval|Median
1293089|NCT00101816|Secondary|Median Duration of Overall Hematologic Response (OHR)|OHR=best confirmed response of MaHR or MiHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1. Maintaining a response was defined as no 2 consecutive records of non-response (ie, a single record of non-response between 2 assessments of response was not considered a loss of response).|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved OHR|||months||95% Confidence Interval|Median
1293090|NCT00101816|Secondary|Median Duration of Major Hematologic Response (MaHR)|MaHR=best confirmed response of CHR or NEL. CHR=white blood cells ≤ institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤ iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement; at least 1 of the following: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved MaHR|||months||Full Range|Median
1293174|NCT00101036|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years||||percentage of responding patients|||Number
1293091|NCT00101816|Primary|Major and Overall Hematologic Response (MaHR and OHR)|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. OHR=best confirmed response of MaHR or minor HR (MiHR). MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts + promyelocytes in bone marrow and <30% blasts + promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|All treated subjects|||Participants|||Number
1293092|NCT00101686|Secondary|Overall Relative Dose Intensity of Irinotecan|Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.)|End of treatment cycle|As-Treated population|||percent dose intensity||Standard Error|Mean
1293093|NCT00101686|Secondary|Dose Reduction Due to Treatment Emergent Adverse Events|Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication.|Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI|As-Treated population - all subjects who received any study medication, with treatment assignments designated according to actual study treatment received.|||participants|||Number
1293094|NCT00101686|Secondary|Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died.|Last Follow-Up Visit|ITT Population.|||months||95% Confidence Interval|Median
1293095|NCT00101686|Secondary|1 Year Survival: Bevacizumab With FOLFIRI, mIFL|Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|1 year from date of randomization|ITT Population.|||participants|||Number
1293096|NCT00101686|Secondary|Overall Response: Bevacizumab With FOLFIRI, mIFL|A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT population.|||participants|||Number
1293097|NCT00101686|Secondary|Time to Progression: Bevacizumab With FOLFIRI, mIFL|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT population.|||months||95% Confidence Interval|Median
1293098|NCT00101686|Secondary|Survival Time: Celecoxib and Placebo|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|assessed at least every week during treatment and at least every 3 months during follow-up|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).|||months||95% Confidence Interval|Median
1293099|NCT00101686|Secondary|Overall Response: Celecoxib and Placebo|A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).|||participants|||Number
1293100|NCT00101686|Secondary|Time to Progression : Celecoxib and Placebo|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).|||months||95% Confidence Interval|Median
1293101|NCT00101686|Secondary|1 Year Survival: FOLFIRI, mIFL and CapeIRI|Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|1 year from date of randomization|ITT Population.|||participants|||Number
1293102|NCT00101686|Secondary|Survival Time: FOLFIRI, mIFL and CapeIRI|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|assessed at least every week during treatment and at least every 3 months during follow-up|ITT Population.|||months||95% Confidence Interval|Median
1293103|NCT00101686|Secondary|Overall Response: FOLFIRI, mIFL and CapeIRI|A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT Population.|||participants|||Number
1293104|NCT00101686|Secondary|Time to Progression: FOLFIRI, mIFL and CapeIRI|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT Population.|||months||95% Confidence Interval|Median
1293175|NCT00100932|Secondary|Overall Survival|Defined as the time from the start of study medication until death from any cause.|From time of start of study medication until death|||||||
1293107|NCT00101660|Secondary|Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE|AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously, from baseline through 2 years|All imitanib-resistant participants who received treatment.|||Participants|||Number
1293108|NCT00101660|Secondary|Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE|AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously, from baseline through 2 years|All imitanib-intolerant participants who received treatment.|||Participants|||Number
1293109|NCT00101660|Secondary|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.|Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.|Number of participants with assessments at baseline and timepoint|||Participants|||Number
1293110|NCT00101660|Secondary|Number of Participants With Major Molecular Response (MMR)|MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.|Baseline to 2 years|All participants who received treatment.|||Participants|||Number
1293111|NCT00101660|Secondary|Median Time From First Dosing Until CHR|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study|Population limited to responders (those achieving CHR) only|||Months||Full Range|Median
1293112|NCT00101660|Secondary|Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months|Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|12 and 24 months|Population limited to responders (those achieving CHR) only|||Percentage of participants|||Number
1293113|NCT00101660|Secondary|Number of Participants With Complete Hematologic Response (CHR)|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study|All participants who received treatment.|||Participants|||Number
1293114|NCT00101660|Secondary|Median Time From First Dosing Date to Date of MCyR|MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.|Baseline (within 4 weeks of Day 1) and every 12 weeks|Population is limited to responders (those who acheived MCyR) only|||Months||Full Range|Median
1293115|NCT00101660|Secondary|Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months|Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.|12 and 24 Months|Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR.|||Percentage of participants|||Number
1293116|NCT00101660|Secondary|Number of Imatinib-intolerant Participants With MCyR|Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.|Baseline to 2 years|All imatinib-intolerant participants who received treatment.|||Participants|||Number
1293117|NCT00101660|Primary|Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.|2 years|All imatinib-resistant participants who received treatment.|||Participants|||Number
1293118|NCT00101647|Secondary|Population PK of Dasatinib|Population pharmacokinetic analysis was not done because it is not meaningful for this single study|Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.||||Population PK analysis|||Number
1293119|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
1293120|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|A total of 29 participants had dense PK sampling on both Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable concentration-time profiles. n=the number of participants on Day 1 and Day 8 who were included in the statistical analyses of PK parameters.|||hours||Standard Deviation|Mean
1293121|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 Hours (AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng∙h/mL||Standard Deviation|Mean
1293122|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng/mL||Standard Deviation|Mean
1293123|NCT00101647|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuous from pretreatment through each 4-week cycle and at follow-up. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).||||Participants|||Number
1293124|NCT00101647|Secondary|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, and functional well-being (PWB, SWB, EWB, FWB). Total score=0 to 108; higher score=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, and FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinically important change.|Baseline, every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up.(treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|Number of participants with FACT-G assessments at baseline and at least one assessment during treatment|||Participants|||Number
1293125|NCT00101647|Secondary|MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations|Major hematologic and cytogenetic responses (MaHR and MCyR) to dasatinib in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). BCR-ABL=the fused gene found in subjects with this type of CML. Criteria for MaHR are specified in Outcome Measure 2. MCyR=combined complete cytogenetic and partial cytogenetic response rate. Complete Cytogenetic Response= 0% Ph+ Cells in Metaphase in Bone Marrow, Partial Cytogenetic Response > 0% to 35% Ph+ Cells in Metaphase in Bone Marrow.|Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 162 of the 174 subjects (12/13 imatinib-intolerant and 150/161 imatinib-resistant). At baseline, 89 (59%) imatinib-resistant subjects and 1 imatinib-intolerant subject expressed imatinib resistant mutations.|||Percentage of participants|||Number
1293137|NCT00101582|Secondary|Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks|"The total dose of opioid analgesics (mg of intravenous [IV] morphine equivalents) used by all participants.~Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents."|Up to 15 weeks|Full analysis set|||mg of IV morphine equivalents||Standard Deviation|Mean
1293126|NCT00101647|Secondary|Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period|Number of participants who achieved an MMR at any time during the treatment period. MMR was calculated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).|Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|Number of Participants Analyzed=all treated subjects who were assessed for major molecular response; n=participants with or without CCyR in cohort.|||participants|||Number
1293127|NCT00101647|Secondary|Best Confirmed Hematologic Response|Number of participants with confirmed complete hematologic response (CHR) or No Evidence of Leukemia (NEL), minor hematologic response (MiHR), or no hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for CHR and NEL are specified in Outcome Measure 2; criteria for MiHR are specified in Outcome Measure 4.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|All treated subjects|||Participants|||Number
1293128|NCT00101647|Secondary|Best Cytogenetic Response|Number of participants with complete, partial, minor, minimal, or no cytogenetic response. Determination of cytogenetic response based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).|Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment|All treated subjects|||Participants|||Number
1293129|NCT00101647|Secondary|Time to OHR|Median time (in months) from first dosing date to date of OHR. OHR=best confirmed response of MaHR or MiHR. Criteria for MaHR specified in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response = response confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|Population comprised of responders only|||days||Full Range|Median
1293130|NCT00101647|Secondary|Median Time in Days From First Dosing Date to Date of MaHR|MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|Population is comprised of responders only|||Days||Full Range|Median
1293131|NCT00101647|Secondary|Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months|Percentage of participants who achieved OHR and did not progress at specified timepoints, based on the Kaplan-Meier estimate of the duration of response. OHR=best confirmed response of MaHR or MiHR. MaHR criteria in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response= confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.|12 months, 24 months|Population is comprised of responders only|||Percentage of responders|||Number
1293132|NCT00101647|Secondary|Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response)|Percentage of participants in the Imatinib-Resistant Group who achieved MaHR and did not progress at Month 24, based on the Kaplan-Meier estimate of the duration of response. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR and NEL are specified in Outcome Measure 2.|24 months|Population comprised of responders only. NOTE: Projected duration of MaHR at 24 months in the Imatinib-Intolerant group was beyond the maximum observed time for this cohort, and therefore only the Imatinib-Resistant group is presented.|||percentage of responders|||Number
1293133|NCT00101647|Secondary|Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)|MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|12 months|Population comprised of responders only.|||percentage of responders|||Number
1293134|NCT00101647|Primary|Major and Overall Hematologic Response (MaHR and OHR)|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|All treated subjects|||participants|||Number
1293135|NCT00101582|Secondary|Number of Participants With Unplanned Breaks in Radiotherapy|Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy.|During the 7 weeks of radiotherapy|Full analysis set|||participants|||Number
1293136|NCT00101582|Secondary|Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment|Cisplatin was administered on Days 1, 22, and 43. An unplanned break in cisplatin refers to a delay of ≥ 5 days from the scheduled Day 22 or Day 43 cisplatin administration or a discontinuation of cisplatin for any reason.|During the 7 weeks of chemotherapy treatment|Full analysis set|||participants|||Number
1293138|NCT00101582|Secondary|Patient-Reported Mouth and Throat Soreness Score|"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).~For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments."|Assessed twice a week for up to 15 weeks.|"The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either:~At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or~70% or greater overall compliance for MTS until withdrawal/Week 8."|||units on a scale||Standard Deviation|Mean
1293139|NCT00101582|Secondary|Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)|The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.|Month 4|Full Analysis Set|||participants|||Number
1293140|NCT00101582|Secondary|Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis|"Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure.~Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM."|Up to 15 weeks|Full analysis set|||days||Inter-Quartile Range|Median
1293141|NCT00101582|Secondary|Duration of Severe (WHO Grade 3 or 4) Oral Mucositis|The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.|Up to 15 weeks|Full analysis set|||days||Inter-Quartile Range|Median
1293142|NCT00101582|Primary|Number of Participants With Severe (Grade 3 or 4) Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral & lateral tongue; left ventral & lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Week 15|The Full Analysis Set included all randomized participants.|||participants|||Number
1293143|NCT00101452|Primary|Hamilton Rating Scale for Depression (HAM-D)|The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.|baseline and 24 weeks|Based on having at least one post-baseline visit.|||units on a scale||Standard Deviation|Mean
1293144|NCT00101439|Secondary|Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal|On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy (~44% of calories from fat, ~40% of calories from carbohydrate and ~17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein subfractions. The geometric mean concentration level was calculated using data obtained at all timepoints.|Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.|Participants who received at least one dose of study drug and did not have any protocol violations.|||mg/dL||Full Range|Geometric Mean
1293145|NCT00101439|Primary|Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal|On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy (~44% of calories from fat, ~40% of calories from carbohydrate and ~17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein fractions. The geometric mean concentration level was calculated using data obtained at all timepoints.|Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.|Participants who received at least one dose of study drug and did not have any protocol violations.|||mg/dL||Full Range|Geometric Mean
1293146|NCT00101413|Secondary|Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)|HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.|From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.|||scores on a scale||Standard Deviation|Mean
1293172|NCT00101036|Secondary|Progression-free Survival|Estimated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|Up to 5 years||||Months||95% Confidence Interval|Median
1293147|NCT00101413|Secondary|Percentage of Subjects With Stable Disease (SD)|Percentage of subjects with stable disease was calculated from date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Descriptive summary of subjects with SD.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.|||Percentage of participants|||Number
1293148|NCT00101413|Secondary|Overall Survival|"Overall survival was calculated from the date of the first treatment until death of the subject.~Evaluation by Kaplan-Meier methodology, descriptive analysis."|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.|||days||95% Confidence Interval|Median
1293149|NCT00101413|Secondary|Duration of Stable Disease|Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.|||days||95% Confidence Interval|Median
1293150|NCT00101413|Primary|Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)|CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- >=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- >=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- >clinically meaningful cancer-related deterioration as judged by the investigator.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.|||percentage of participants|||Number
1293151|NCT00101400|Secondary|Number of Subjects With Stable Disease up to Cycle 4|Number of subjects who had not responded to treatment but had stable disease up to cycle 4.|Until 30 days after termination of active therapy|Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.|||participants|||Number
1293152|NCT00101400|Secondary|Survival Time|After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls).|Start of treatment to death|Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.|||days||95% Confidence Interval|Median
1293153|NCT00101400|Secondary|Overall Response Duration|Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR). It was measured from start of treatment to the date when progressive disease was first objectively documented.|Time from PR or CR to progression|1 subject out of 54 achieved PR.|||days|||Number
1293154|NCT00101400|Secondary|Time to Objective Response|Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria.|Until objective response occurs|1 subject out of 54 achieved PR.|||days|||Number
1293155|NCT00101400|Secondary|Time to Progression|Time from start of treatment until progression was first documented.|Until progression occurs|Of the intent to treat population, 4 subjects died before assessment of progression; for 1 subject the progression date not available; and 1 subject was lost to follow-up.|||days||95% Confidence Interval|Median
1293156|NCT00101400|Primary|Number of Subjects With Response (Complete or Partial)|Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.|Until 30 days after termination of active therapy|Intent to treat population consisted of subjects who received at least 1 dose of sorafenib.|||participants|||Number
1293157|NCT00101361|Primary|A Healed Pressure Ulcer|Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.|healing was measured from randomization to full healing or 24 weeks, whichever occured first.||||participants|||Number
1293158|NCT00101283|Secondary|Progression-Free Survival|Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.|||Months||95% Confidence Interval|Median
1293159|NCT00101283|Secondary|Overall Survival|Time from randomization to death. Patients alive at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.|||Months||95% Confidence Interval|Median
1293173|NCT00101036|Secondary|Overall Survival|Estimated by the Kaplan-Meier method.|Up to 5 years||||Months||95% Confidence Interval|Median
1293160|NCT00101283|Primary|Best Overall Response by RECIST Criteria (Version 1.0)|Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.|Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.|||eligible, treated participants|||Number
1293161|NCT00101192|Secondary|Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment||up to 5 years from study entry|||||||
1293162|NCT00101192|Primary|Tumor Response|"Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria:~Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions.~Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease: any condition not meeting the above criteria.~Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|up to 6 months from study entry|Eligible and evaluable participants|||participants|||Number
1293163|NCT00101166|Secondary|Overall Survival (OS) in Months|Average overall survival time in months.|Average of 14 months|All 28 participants who were vaccinated on this study.|||months||95% Confidence Interval|Mean
1293164|NCT00101166|Secondary|Time to Progression (TTP) in Months|Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Average of 14 months|All 28 participants who were vaccinated on this study.|||months||95% Confidence Interval|Mean
1293165|NCT00101166|Secondary|Number of Participants With Stable Disease|Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Average of 14 months|All 28 participants who were vaccinated on this study.|||participants|||Number
1293166|NCT00101166|Primary|Number of Participants With Partial Response|Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Average of 14 months|All 28 participants who were vaccinated on this study.|||participants|||Number
1293167|NCT00101166|Secondary|Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment|Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3).|Average of 14 months|All 28 participants who were vaccinated on this study.|||participants|||Number
1293168|NCT00101101|Secondary|Median Event Free Survival (EFS)|Vaccine Response - EFS among participants who received vaccination. Event free survival (EFS) was calculated from date of enrollment until progression or death from any cause. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|18 months|Participants who received at least one vaccine injection.|||months||95% Confidence Interval|Median
1293169|NCT00101101|Secondary|Occurrence of Related Serious Adverse Events (SAEs)|Patients were monitored for toxicity every 4 weeks in clinic throughout the 4-month vaccination phase. This included clinical and laboratory evaluation (CBC, blood urea nitrogen (BUN), creatinine, electrolytes, liver function test (LFT), and serum LDH). Toxicity was defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE-3) Version 3.0 (www.ctep.cancer.gov). Grade 3 or higher SAEs attributed to vaccination: Toxicity was assessed in the 23 patients who received at least one vaccine injection.|4 months per participant|Participants who received at least one vaccine injection.|||participants|||Number
1293170|NCT00101101|Primary|Rate of Immunological Response to Vaccination|"Immunological response to vaccination, as measured by in vitro testing of peripheral blood mononuclear cells (PBMCs) for interferon gamma secretion, delayed type hypersensitivity reaction (DTH) in response to irradiated autologous tumor cells, and lymphocyte accumulation at DTH and vaccine injection sites.~DTH Skin Testing was performed within 2 weeks prior to first vaccine, and again after fourth vaccine was administered. Aliquots containing 10^6 irradiated autologous tumor cells were re-suspended in 0.2 mL of Plasma-Lyte A and injected intradermally in the forearm and marked. 48 hours later, injection site was inspected for induration and erythema.~3mm punch biopsy of DTH injection site and vaccine site was obtained 48 hours after administration of irradiated tumor cells before and after the vaccine series. Vaccine site biopsy was obtained 2-5 days after the second vaccine had been given. Granulocytic and lymphocytic accumulation at these sites was graded by a pathologist."|4 months per participant|Participants who received at least one vaccine injection.|||participants|||Number
1293171|NCT00101036|Secondary|Disease Control Rate.|"The mathematical sum of percentages of complete response, partial response and stable disease.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions"|Up to 5 years||||percentage of participants|||Number
1293176|NCT00100932|Secondary|Progression Free Survival|Defined as the time from the start of study medication until progressive disease or death from any cause during the study period.|From start of study medication until progressive disease or death|Intent to Treat/Safety Population|||Days||Full Range|Median
1293177|NCT00100932|Secondary|Duration of Response|Measured from the time that measurement criteria were met for complete response (CR) and partial response (PR) until the first date that recurrence or progressive disease was objectively documented.|From time of CR or PR until recurrence or progressive disease|Intent to Treat/Safety Population|||Days||Full Range|Median
1293178|NCT00100932|Primary|Overall Objective Response Rate (ORR)|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|From start of treatment until disease progression or recurrence|Intent to Treat/Safety Population|||percentage of participants|||Number
1293179|NCT00100841|Primary|Progression Free Survival Rate||From randomization to the first documented disease progression||||months||95% Confidence Interval|Median
1293180|NCT00100841|Primary|Severe Adverse Event (SAE) Rate|The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation|The duration of the study|66 patients treated with cetuximab|||participants|||Number
1293181|NCT00100828|Primary|Response Rate|To determine the response rate of this regimen of irinotecan in patients with metastatic MTC|Every 2 cycles|Study was closed to enrollment due to low accrual. Data was not collected for this outcome measure.||||||
1293182|NCT00100815|Secondary|Overall Survival||every 2-4 months for 1 year and then every 6 months for 5 years|All treated and eligible patients|||months||90% Confidence Interval|Median
1293183|NCT00100815|Secondary|Clinical Response|Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR.|Pre-treatment and every 6 weeks from treatment.|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1293184|NCT00100815|Secondary|Percentage of Participants With Improved Quality of Life|Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score.|assessed at baseline then weekly for 3 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1293185|NCT00100815|Secondary|Percentage of Participants With Grades 3-5 Treatment Related Toxicities|Grade 3, 4 or 5 toxicity rate|Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1293186|NCT00100815|Primary|Progression-free Survival|Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|every 2-4 months for 1 year and then every 6 months for 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1293187|NCT00100802|Primary|Occurrence of Death Attributable to Complications of Protocol Therapy|Number of deaths due to complications of protocol therapy.|While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy|106 eligible patients out of 118 patients enrolled is the population basis for this outcome measure.|||patients|||Number
1293188|NCT00100802|Primary|One Year Overall Survival|Estimated one year survival using the Kaplan-Meier methodology.|One year|Population is based on 106 eligible patients out of 118 patients enrolled.|||Estimated probability||95% Confidence Interval|Number
1293189|NCT00100789|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants with a given type of AE|||Number
1293190|NCT00100789|Secondary|Response|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|9 weeks - 3 years|All eligible patients with measurable disease who started treatment were included in response measures.|||participants|||Number
1293191|NCT00100789|Primary|Overall Survival|Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|0 - 3 years|All eligible patients who started treatment were included in this measure.|||months||95% Confidence Interval|Median
1293192|NCT00100789|Secondary|Progression-free Survival|Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 3 years|All eligible patients who started treatment were included in this measure.|||months||95% Confidence Interval|Median
1293193|NCT00100698|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure|18 months||||mm Hg||Standard Error|Mean
1293194|NCT00100698|Secondary|Change in 2-hour Glucose|Change in 2-hour glucose|18 months||||mg/dL||Standard Error|Mean
1293200|NCT00100698|Secondary|Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months|Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.|18 months||||units on a scale||Standard Error|Mean
1293201|NCT00100698|Secondary|Change in Lean Body Mass|change in lean body mass|18 months||||kilograms||Standard Error|Mean
1293202|NCT00100698|Secondary|Change in Logarithm HIV Viral Load|Change in logarithm base 10 HIV viral load|18 months||||log base 10 copies of RNA/milliliter||Standard Error|Mean
1293203|NCT00100698|Secondary|Change in CD4 Cells|Change in CD4 cells|18 months||||cells/microliter||Standard Error|Mean
1293204|NCT00100698|Secondary|Change in Subcutaneous Adipose Tissue|Change in subcutaneous adipose tissue|18 months||||centimeters squared||Standard Error|Mean
1293205|NCT00100698|Secondary|Change in Triglycerides|Change in triglycerides|18 months||||mg/dL||Inter-Quartile Range|Median
1293206|NCT00100698|Secondary|Change in Trunk to Extremity Ratio|change in trunk to extremity ratio|18 months||||kilogram per kilogram||Standard Error|Mean
1293207|NCT00100698|Secondary|Change in Fasting Glucose|change in fasting glucose|18 months||||mg/dL||Standard Error|Mean
1293208|NCT00100698|Secondary|Change in Trunk Fat||18 months||||kilograms||Standard Error|Mean
1293209|NCT00100698|Secondary|Change in Insulin-like Growth Factor-I From Baseline to 18 Months|Change in insulin-like growth factor-1|18 months||||nanograms/milliliter||Standard Error|Mean
1293210|NCT00100698|Primary|Change in Visceral Adipose Tissue Area From Baseline to 18 Months|change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan|18 months||||centimeters squared||Standard Error|Mean
1293211|NCT00100659|Secondary|Adverse Events|Influenza-like, headache, and gastrointestinal symptoms|At any time up to 72 weeks||||Participants|||Count of Participants
1293212|NCT00100659|Primary|Sustained Viral Response (SVR)|SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma|at least 24 weeks after stopping treatment.||||participants|||Number
1293213|NCT00100230|Other Pre-specified|Loss of Peripheral Visual Fields|Hypothesis: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of peripheral visual fields in this 4-year trial.|4 years|Only participants completing at least one year of trial|||decibels (dB)||Standard Error|Mean
1293214|NCT00100230|Secondary|Rate of LOSS of Rod Electroretinographic Function|Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of rod electroretinographic response in this 4-year trial.|4 years|Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)|||change in amplitude, log microvolts/year||Standard Error|Mean
1293215|NCT00100230|Primary|Rate of LOSS of 31 Hertz Cone Electroretinographic Function|Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of 31 hertz cone electroretinographic response in this 4-year trial.|4 years|Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)|||log microvolts/year||Standard Error|Mean
1293216|NCT00100178|Primary|Mean Stimulated C-peptide Area Under the Curve|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|2 years|Participants who completed a 4-hour mixed meal glucose tolerance test at the two-year visit were included in the analysis|||pmol/ml||95% Confidence Interval|Geometric Mean
1293217|NCT00100048|Other Pre-specified|Number of Patients That Discontinued With LAEs||48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293218|NCT00100048|Secondary|Change From Baseline in CD4 (T-helper) Cell Count at Week 240|Change in number of CD4 cells/mm^3 from baseline to Week 240.|Baseline and Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.|||cells/mm^3||95% Confidence Interval|Mean
1293219|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.|Baseline and Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.|||Log10Copies/mL||95% Confidence Interval|Mean
1293220|NCT00100048|Secondary|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.|Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.|||Participants|||Number
1293221|NCT00100048|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline and Week 96|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.|||cells/mm3||95% Confidence Interval|Mean
1293222|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 96||Baseline and Week 96|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.|||copies/mL||95% Confidence Interval|Mean
1293223|NCT00100048|Secondary|Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96||96 Weeks|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.|||participants|||Number
1293224|NCT00100048|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)|Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)|Baseline and Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||cells/mm3||95% Confidence Interval|Mean
1293225|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)|Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)|Baseline and Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||copies/mL||95% Confidence Interval|Mean
1293226|NCT00100048|Primary|Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.|Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.|||Participants|||Number
1293227|NCT00100048|Primary|Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)|"An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose."|Week 240|The analysis population was based upon the All Patients As Treated (APaT) approach.|||Participants|||Number
1293228|NCT00100048|Secondary|Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)||Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||participants|||Number
1293229|NCT00100048|Primary|Number of Patients With Serious CAEs and Non-serious CAEs at Week 144|"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product~An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product"|144 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293230|NCT00100048|Primary|Number of Patients With Serious CAEs (Cohort I and II Combined)|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293231|NCT00100048|Other Pre-specified|Number of Patients With Serious Drug-related LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293232|NCT00100048|Other Pre-specified|Number of Patients With Drug-related LAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293233|NCT00100048|Other Pre-specified|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293234|NCT00100048|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 Weeks|"The analysis population is based upon the All~Patients As Treated (APaT) approach."|||participants|||Number
1293235|NCT00100048|Other Pre-specified|Number of Patients That Discontinued With CAEs||48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293236|NCT00100048|Other Pre-specified|Number of Patients With Serious Drug-related CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach|||participants|||Number
1293237|NCT00100048|Other Pre-specified|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293238|NCT00100048|Other Pre-specified|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48||48 weeks|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||participants|||Number
1293239|NCT00100048|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293240|NCT00100048|Primary|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)||Week 24|"The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.~All patients who took study medication and had HIV RNA tests performed were included in the analysis."|||participants|||Number
1293241|NCT00100048|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)|"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.~Serious CAEs are any AEs occurring at any dose that; Results~in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or~prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an~overdose."|10 days|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
1293242|NCT00100048|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)|Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)|Baseline and Day 10|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||copies/mL||95% Confidence Interval|Mean
1293243|NCT00099983|Primary|Change in CAPS Score From Baseline to Week 24|The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score.|24 Weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1293244|NCT00099632|Secondary|Number of Participants Who Discontinued Study Treatment Prematurely|participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively.|From first day of study treatment to last day of study treatment (up to 21 days)||||participants|||Number
1293245|NCT00099632|Secondary|Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12|"Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12.~Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death"|From first day of study treatment to week 12||||participants|||Number
1293246|NCT00099632|Secondary|Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.|For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.|2 and 6 weeks after completion of treatment||||participants|||Number
1293247|NCT00099632|Secondary|Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.|For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.|2 and 6 weeks after completion of treatment||||participants|||Number
1293248|NCT00099632|Primary|Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping|"For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint.~10 participants who did not have resistance samples available were excluded from the primary endpoint analysis."|2 and 6 weeks after completion of treatment|412 women with primary endpoint results available|||participants|||Number
1293249|NCT00099437|Secondary|Overall Survival (OS) - Follow-up|Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)|Median time (in months) from randomisation until death (from any cause),up to 80 months|All randomised patients|||months||Full Range|Median
1293250|NCT00099437|Secondary|Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study|Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.|TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)||||Scores on a scale||Standard Deviation|Mean
1293251|NCT00099437|Secondary|Overall Survival (OS)|Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )|Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)|All patients with measurable disease at baseline.|||Time (in months)||Full Range|Median
1293335|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels."|||percentage of participants|||Number
1293252|NCT00099437|Secondary|Duration of Clinical Benefit (DoCB)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)||||Time (in months)||Full Range|Median
1293253|NCT00099437|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)||||Time (in months)||Full Range|Median
1293254|NCT00099437|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.|Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)||||Percentage of patients|||Number
1293255|NCT00099437|Secondary|Objective Response Rate (ORR)|Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|All patients with measurable disease at baseline.|||Percentage of patients|||Number
1293256|NCT00099437|Primary|Time to Progression (TTP)|Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).|RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)||||months||Full Range|Median
1293257|NCT00099359|Secondary|NVP Pharmacokinetics|Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants.|14 days||||ng/mL||Full Range|Median
1293258|NCT00099359|Secondary|Risk Factors for Perinatal HIV-1 Transmission|Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication.|through age 3 months|All available demographic and clinical variables were tested for association with transmission rate. All variables that were significant at p ≤ 0.20 were included in the multivariable regression model. Variables that were not significant were then removed from the model. The backward elimination method was used to select the final model.|||participants|||Number
1293259|NCT00099359|Secondary|3TC and NFV Pharmacokinetics|Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants.|through age 14 days|This was a descriptive study. A total of 26 infants were analyzed with 14 at age 4-7 days and 12 at 10-14 days.Plasma samples were collected prior to first AM dose and then at 1,2,4,8 and 12 hours.|||ug*h/mL||Full Range|Median
1293260|NCT00099359|Secondary|Clinical Covariates of HIV-1 Infection|Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens.|through age 3 months|||||||
1293261|NCT00099359|Secondary|Participant Deaths||through age 6 months||||participants|||Number
1293262|NCT00099359|Secondary|Infant HIV-1 Infection Status|In utero HIV-1 infection rate|birth||||participants|||Number
1293263|NCT00099359|Primary|Participants With Serious Adverse Events|Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders|through age 6 months.||||participants|||Number
1293264|NCT00099359|Primary|Infant HIV Infection Status|Intrapartum HIV infection at 3 Months|3 months|All infants with HIV-1 test results except infants infected at birth (i.e. in utero infections) were included in these analysis.|||participants|||Number
1293265|NCT00099268|Secondary|Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)|The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 156|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.|||Units on a scale||Standard Deviation|Mean
1293266|NCT00099268|Secondary|Occurrence of Dyskinesia|Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered “yes” to the following question: “In your opinion, does this patient have dyskinesia?”|Baseline to Week 208|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued from treatment before 134 weeks without dyskinesia were excluded.|||Participants|||Number
1293267|NCT00099268|Secondary|Time to First Occurrence of Wearing-off|Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.|Baseline to end of study (134-208 weeks of treatment)|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.|||Weeks||Standard Error|Mean
1293417|NCT00098254|Primary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 1/2 years||||Participants|||Number
1293268|NCT00099268|Secondary|Occurrence of Wearing-off|Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.|Baseline to Week 134|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued treatment before 134 weeks without wearing-off were excluded.|||Participants|||Number
1293269|NCT00099268|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)|The UPDRS is a standardized assessment scale used to measure the patient’s disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient’s activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline, Week 6 and Week 130|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.|||Units on a scale||Standard Deviation|Mean
1293270|NCT00099268|Primary|Time to First Occurrence of Dyskinesia|Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered “yes” to the following question: “In your opinion, does this patient have dyskinesia?” Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.|Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.|||weeks||95% Confidence Interval|Number
1293271|NCT00099047|Primary|Changes in M-protein Levels|For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.|Baseline and 6 months|One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.|||g/dL||Standard Deviation|Median
1293272|NCT00099021|Secondary|Interleukin 6, 8 and Vascular Endothelial Growth Factors Elaboration in the Oral Cavity and Serum|Quantitative studies of serum and saliva components for a pre and post treatment possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293273|NCT00099021|Secondary|Quantitative Oil Red O, AP2 (FABP4) and FABP5 Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293274|NCT00099021|Secondary|Involucrin and Transglutaminase Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293275|NCT00099021|Secondary|Cyclin D1 and p21 Immune Histochemistry|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293276|NCT00099021|Secondary|Cyclooxygenase-2 Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293277|NCT00099021|Secondary|Pigliotazone Gamma Immune Histochemistry|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293278|NCT00099021|Secondary|Apotosis (Cell Death)|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293279|NCT00099021|Secondary|Ki 67 Labeling Index|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293280|NCT00099021|Secondary|Nf Kappa B p65|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
1293281|NCT00099021|Secondary|Patients' Histological (Tissue) Response|Determined by biopsy results before and 4 weeks after treatment: Complete Response (CR) =complete reversal of dysplasia or hyperplasia, Partial Response (PR) = >or=50% decrease in sum of lesions, no increase in 1 or more lesions and no new lesion occurs, Stable Disease (SD0 = not CR, PR or Progressive Disease (PD), PD = >or= 25% increase in sum of lesions or new lesion or progression to invasive carcinoma.|Week 16 (4 weeks post dose)||||Participants|||Number
1293282|NCT00099021|Secondary|Patients' Clinical Response|Determined by measurement of lesions- Complete Response (CR)= disappearance of all lesions, Partial Response (PR)= >or= 50% decrease in sum of lesions, Stable Disease (SD) = does not meet CR,PR or Progressive Disease (PD), and PD= >or= 25% increase in sum of lesions|Week 16 (4 weeks post dose)||||Participants|||Number
1293283|NCT00099021|Primary|Patients' Overall Response|"Overall Response= reviewing both the clinical and histological responses and assigning the worst category.~Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD"|Week 16 (4 weeks post dose)||||Participants|||Number
1293284|NCT00098956|Secondary|Adverse Events, Graded Using the CTCAE Version 3.0||Up to 5 years||||types of grade 3 / 4 toxicities reported|||Number
1293285|NCT00098956|Secondary|Overall Survival||From the date of enrollment to death or last contact, assessed up to 5 years|Data were not collected||||||
1293286|NCT00098956|Secondary|Progression-free Survival||From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years|Data were not collected||||||
1293287|NCT00098956|Secondary|Duration of Responses||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|Data were not collected||||||
1293288|NCT00098956|Secondary|Stable Disease Rate Evaluated Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 5 years||||participants|||Number
1293289|NCT00098956|Primary|Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 5 years||||participants|||Number
1293290|NCT00098865|Secondary|Overall Survival|Time from registration to death. Patients alive at last follow-up were censored.|Assessed after treatment discontinued every 3 months up to 2 years.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1293291|NCT00098865|Secondary|Overall Response|"Overall response is the best response during 6 months of therapy measured by radiographic response.~Complete Response (CR): Disappearance of all detectable tumors by imaging, if initially positive, as well as 2 consecutively negative CSF cytologic examinations (if the initial cytology was positive).~Partial Response (PR): > 50% reduction in the sum of the products of the maximum perpendicular diameter of all measurable lesions; or 2 consecutively negative CSF cytologies and a < 50% reduction in tumor size.~Stable Disease (SD): < 50% reduction in the sum of the products of the maximum perpendicular diameters of all measurable lesions, and persistently negative or positive CSF cytology Progressive Disease (PD): > 25% increase in the size of any measurable lesion, the appearance of a new radiographically demonstrable lesion, or the conversion of negative CSF cytology to positive, as confirmed by at least one repeat CSF cytology"|Assessed every 8 weeks while on treatment and every 3 months for one year off-study||||participants|||Number
1293292|NCT00098865|Primary|Therapy Completion Rate|Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.|6 months|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
1293293|NCT00098839|Secondary|Pharmacokinetics|Mean trough serum concentration measured before final dose of epratuzumab.|Up to day 36|Pharmacokinetics (PK) were added to the protocol with amendment 5A for the twice weekly dosing schedule of Epratuzumab. Hence, PK studies were limited to evaluable patients on this Arm only.|||ug/mL||Standard Deviation|Mean
1293294|NCT00098839|Primary|Rate of Minimal Residual Disease (MRD) < 0.01%|Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%.|At the end of Block 1 of re-induction therapy (day 36)|Evaluable patients who had MRD measured at the end of Block 1. There were 2 ineligible patients for once weekly arm and 13 patients where MRD was not measured at the end of block 1 re-induction therapy. There were 16 patients for twice weekly arm where MRD was not measured at the end of block 1 re-induction therapy.|||Proportion of participants|||Number
1293295|NCT00098839|Primary|Event-free Survival Rate|Proportion of patients who were event free at 4 months|At 4 months after enrollment|Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.|||Proportion of participants|||Number
1293296|NCT00098839|Primary|Remission Re-induction (CR2) Rate|The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count.|At the end of Block 1 of re-induction therapy (day 36)|Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.|||proportion of participants|||Number
1293297|NCT00098813|Primary|Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria||From start of treatment to 8 weeks||||participants|||Number
1293298|NCT00098787|Secondary|Overall Survival (OS)|Overall survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to death. Patients alive at last follow-up were censored.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.|Eligible and treated patients|||months||95% Confidence Interval|Median
1293299|NCT00098787|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.|Eligible and treated patients|||months||95% Confidence Interval|Median
1293300|NCT00098787|Primary|Objective Response Rate|Objective response rate is defined as proportion of patients who achieve complete response (CR) or partial response (PR). Response was assessed using Solid Tumor Response Criteria (RECIST). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months up to 4 years post-registration.|Eligible and treated patients|||proportion||90% Confidence Interval|Number
1293301|NCT00098774|Secondary|4 Year Overall Survival Rate|Percentage of patients who were alive at 4 years. The 4-year survival rate was estimated using the Kaplan Meier method.|4 years||||percentage of participants||95% Confidence Interval|Number
1293663|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 12|Laboratory hematology hemoglobin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||g/L||Standard Deviation|Mean
1293302|NCT00098774|Secondary|Change From Baseline in Mini-Mental Status Evaluation at 4 Months|Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.|Baseline & month 4|Only 14 participants had both baseline and 4 month MMSE evaluations reported.|||units on a scale||Full Range|Median
1293303|NCT00098774|Secondary|4 Year Progression Free Rate|"Percentage of patients who were progression free at 4 years. The 4-year progression free rate was estimated using the Kaplan Meier method.~Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a 25% increase of previous area of gadolinium enhancement, appearance of new areas of T1 gadolinium enhancement or new appearance of malignant cells in the spinal fluid or new tumor appearance in other sites of the body"|4 years||||percentage of participants||95% Confidence Interval|Number
1293304|NCT00098774|Primary|Complete Response Rate After Remission Induction|Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.|4 months||||percentage of participants||95% Confidence Interval|Number
1293305|NCT00098748|Secondary|Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)|Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per CDC HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.|Baseline through Week 48|FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.|||participants|||Number
1293306|NCT00098748|Secondary|Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)|Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.|Baseline through Week 24|FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.|||participants|||Number
1293307|NCT00098748|Secondary|Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening|Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0, 1, 2, or ≥3 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Screening, Week48|FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.|||particpants|||Number
1293308|NCT00098748|Secondary|Number of Subjects With Treatment Failure at Week 24 by Overall Susceptibility Score (OSS) at Screening|Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0-1, 2-4, >4 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Screening, Week 24|FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.|||participants|||Number
1293309|NCT00098748|Secondary|Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)|Number of subjects per Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.|Screening through Week 48|FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).|||participants|||Number
1293310|NCT00098748|Secondary|Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)|Number of subjects per Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.|Screening through Week 24|FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).|||participants|||Number
1293311|NCT00098748|Secondary|Number of Subjects Per Genotype and Phenotype at Baseline and at Time of Failure|Number of subjects per genotype and phenotype (tests for presence of non CCR5-tropic HIV-1 and for resistance to reverse transcriptase, protease, and fusion inhibitors) at baseline and at time of failure through Week 48 visit. Sensitivity to drug categorized as 0-1, 2-4, >4; scores defined as 0=resistance, 1=sensitive or susceptible with higher number indicating greater sensitivity or susceptibility.|Baseline through Week 48|FAS-as treated dual-tropic subjects. Genotype and phenotype at screening and at time of failure were not summarized as planned.|||participants|||Number
1293312|NCT00098748|Secondary|Change From Baseline in Time Averaged Difference (TAD) in log10 HIV-1 RNA|Change from baseline of TAD in log10 HIV-1 RNA viral load calculated as [AUC of HIV-1 RNA viral load (log10 copies/mL) / time period] - Baseline HIV-1 RNA viral load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Discontinuations prior to time point of analysis imputed as 0.|||log10 copies/mL||Standard Error|Mean
1293664|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 6|Laboratory hematology hemoglobin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||g/L||Standard Deviation|Mean
1293313|NCT00098748|Secondary|Time (50% Quartile Point Estimate) to Virologic Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of test drug [perm DC]; lost to follow-up [LTFU]; new anti-retroviral drug added (except background drug change to drug of same class); or on open label for early non-response or rebound). Failure: at Time 0 if level not <400 copies/mL (2 consecutive visits) before event(s) or last available visit; at time of earliest event if level <400 copies/mL (on 2 consecutive visits); failure if level ≥400 copies/mL (2 consecutive visits) or 1 visit ≥400 copies/mL followed by perm DC or LTFU.|Day 1 through Week 24 and through Week 48|FAS - as treated dual-tropic subjects; (n)=number of subjects with virologic failure at observation for maraviroc QD, maraviroc BID, and placebo, respectively; Week 48 result values (0.00)=virologic failure at Day 0.|||days||95% Confidence Interval|Median
1293314|NCT00098748|Secondary|Change From Baseline in CD8 Cell Count|Change from baseline in CD8 cell count (measured as cells/µL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.|||cells/µL||Standard Error|Mean
1293315|NCT00098748|Secondary|Change From Baseline in CD4 Cell Count|Change from baseline in CD4 cell count (measured as cells per microliter [cells/µL]). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.|||cells/µL||Standard Error|Mean
1293316|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 50 Copies/mL||Baseline, Week 24, Week 48|FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).|||participants|||Number
1293317|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 1.0 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels|Number of subjects with HIV-1 RNA levels < 400 copies/mL or at least 1.0 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline, Week 24, Week 48|FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).|||participants|||Number
1293318|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 0.5 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels|Number of subjects with HIV-1 RNA levels < 400 copies/mL or at least 0.5 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline, Week 24, Week 48|FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).|||participants|||Number
1293319|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL||Week 24, Week 48|FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).|||participants|||Number
1293320|NCT00098748|Primary|Change From Baseline in Human Immunodeficiency Virus (HIV-1) Viral Load (Ribonucleic Acid [RNA])|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/mL]). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|Full Analysis Set (FAS)-as treated: all randomized subjects classified as dual-tropic by phenotype assay; received at least 1 dose of study treatment. Missing values: discontinuations (DC) imputed as baseline value (change from baseline=0); missing data imputed as Last Observation Carried Forward (LOCF).|||log10 copies/mL||Standard Error|Mean
1293321|NCT00098722|Secondary|Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.|Baseline, Week 24 and Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm measured at particular time-point. LOCF was used to impute missing values.|||log10copies/mL||Standard Deviation|Mean
1293322|NCT00098722|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
1293323|NCT00098722|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through Week 24|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
1293418|NCT00098254|Primary|Progression Free Survival|"Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions.~Appearance of one or more new lesions and/or unequivocal progressions of existing non-target lesions."|17 months||||months||95% Confidence Interval|Median
1293324|NCT00098722|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.|||participants|||Number
1293325|NCT00098722|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through Week 24|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.|||participants|||Number
1293326|NCT00098722|Secondary|Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening|FAS included all the randomized participants who had taken at least one dose of the study medication.|||participants|||Number
1293327|NCT00098722|Secondary|Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline to Week 24 and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
1293328|NCT00098722|Secondary|Time to Virological Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication.|||days||95% Confidence Interval|Median
1293329|NCT00098722|Secondary|Change From Baseline in CD8 Cell Count at Week 24 and 48|Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/μL||Standard Error|Least Squares Mean
1293330|NCT00098722|Secondary|Change From Baseline in CD4 Cell Count at Week 24 and 48|Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/μL||Standard Error|Least Squares Mean
1293331|NCT00098722|Secondary|Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||cells per microliter (cells/μL)||Standard Deviation|Mean
1293332|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels."|||percentage of participants|||Number
1293333|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels."|||percentage of participants|||Number
1293334|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels."|||percentage of participants|||Number
1293336|NCT00098722|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as LOCF for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
1293337|NCT00098722|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 24|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
1293338|NCT00098722|Primary|Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline|Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.|||log10 copies/milliliter(log10 copies/mL)||Standard Deviation|Mean
1293339|NCT00098670|Secondary|Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab|"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|6 weeks beginning at study week 36|58 participants were treatment with Alemtuzumab.|||participants|||Number
1293340|NCT00098670|Secondary|2 Year Survival|Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.|2 years from registration||||percentage of participants|||Number
1293341|NCT00098670|Secondary|2 Year Progression Free Survival|Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method.|2 years from registration||||percentage of participants|||Number
1293342|NCT00098670|Secondary|Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab|"Response, as defined by the National Cancer Institute Working Group (NCIWG):~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|Up to 9 months||||participants|||Number
1293343|NCT00098670|Primary|Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab|"A complete response, as defined by the National Cancer Institute Working Group (NCIWG):~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy"|Duration of treatment (up to 13.5 months)|58 participants were treated with Alemtuzumab.|||participants|||Number
1293344|NCT00098475|Secondary|Proportion of Patients With Objective Response (First Phase, Step 2)|"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only."|Assessed every 4 weeks for 16 weeks during Step 2|Only eligible patients were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1293345|NCT00098475|Primary|Proportion of Patients With Objective Response (First Phase, Step 1)|"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only."|Assessed every 4 weeks for 16 weeks during Step 1|Only eligible patients were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1293346|NCT00098371|Secondary|Comparison of Clinical Response and Tumor Lysis in Vivo With Drug-induced Apoptosis and Mitochondrial Perturbation in Vitro as Assessed by Flow Cytometry|CLL cells will be incubated with control or flavopiridol (1 or 2.8 microMolar) for 4-hours followed by a 20 hours in media with 10% heat-inactivated human serum. Assessment of apoptosis following exposure of human CLL cells will be performed using annexin/PI flow cytometry. Patient samples with greater than 50% live cells (annexin-/PI-) following exposure to 2.8 microMolar flavopiridol will be considered to have insensitive disease. Patients whose CLL cells have less than 50% live cells at 1 microMolar will be considered to have highly sensitive disease.|At baseline|A subset of patients who had sufficient material were analyzed according to response only.|||percentage of priming cells||Standard Deviation|Mean
1293665|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 3|Laboratory hematology hemoglobin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||g/L||Standard Deviation|Mean
1293347|NCT00098371|Secondary|Levels of Mcl-1 mRNA, Mcl-1 Protein, HIF-1alpha Protein, HIF-1alpha mRNA, NF-kappaB Activation, Total IkB, IkB Phosphorylation, GSK-beta Activity, and IL-6 Target Genes (i.e., STAT3)|Assessed by real time RT-PCR (mcl-1, HIF-1alpha), immunoblot analysis (mcl-1, HIF-1alpha, I-kappaB, I-kappaB phosphorylation, targets of IL-6), and electrophoretic mobility shift analysis (NF-kappaB activation)|At baseline, 4.5 hours (end of continuous infusion), 8 hours, and approximately 24 hours following initiation of therapy|Data was not collected and analyzed for this outcome||||||
1293348|NCT00098371|Secondary|Correlation of Adverse Prognostic Factors With Response to Flavopiridol Treatment as Assessed by Interphase Cytogenetics, VH Mutational Status, ZAP-70 Protein Expression, CD38, and p53|overall response rates (CR+PR)|up to 8 months|Data were not collected and analyzed for VH mutational status, ZAP-70 protein expression, CD38, and p53|||percentage of patients in each subgroup|||Number
1293349|NCT00098371|Secondary|Comparison of CLL Cell Samples Taken at Registration/Diagnosis to CLL Cell Samples Taken at Time of Relapse|Samples will be examined for ex vivo sensitivity to flavopiridol, expression of select anti-apoptosis proteins, BCRP mRNA and protein expression, difference in gene expression by cDNA microarray and potentially by epigenetic arrays. Comparisons will be used to evaluate mechanisms of acquired flavopiridol resistance.|At baseline and at time of relapse or when patient goes off therapy due to disease progression|Data for this outcome as not collected and analyzed||||||
1293350|NCT00098371|Secondary|Serial Levels of IL-6 as Assessed by Blood Plasma|IL-6 measures were adjusted for baseline values|4.5 hours, 8 hours, 12 hours, and 24 hours following the initiation of therapy during day 1 of course 1|IL-6 expression analysis was available for only day 1 and not day 8.|||pg/ml||95% Confidence Interval|Mean
1293351|NCT00098371|Secondary|PK as Assessed by Levels of Both Flavopiridol and Metabolites of Flavopiridol in Urine Samples|urine samples were collected in some patients during the first 24 hours after the start of the infusion on cycle 1, day 1 to isolate metabolites of flavopiridol to be used as internal standard for plasma metabolite quantification experiments.|Urine collected at 4 separate times in some patients during the first 24 hours after start of infusion on day 1 of course 1.|Data for this PK analysis was not collected and analyzed.||||||
1293352|NCT00098371|Secondary|PK (Cmax) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol|Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol|During treatment day 1 and day 8 of course 1|The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.|||μM||Standard Deviation|Mean
1293353|NCT00098371|Secondary|Pharmacokinetics (PK) (AUC) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol|Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol using Area Under the Curve (AUC)|During treatment day 1 and day 8 of cycle 1|The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.|||μM*hr||Standard Deviation|Mean
1293354|NCT00098371|Primary|Toxicity|Toxicity determination based on NCI Common Toxicity Criteria version 3 and modified NCI Common toxicity guidelines for evaluating hematologic toxicity in leukemia.|Measurement prior to each infusion, at end of therapy, 2 months post-completion and post-treatment follow-up every 3 months for two years.|Grade 3 to 4 infections requiring IV antibiotics and were generally related to upper or lower respiratory infections or infections of indwelling central venous catheters.|||percentage of patients|||Number
1293355|NCT00098371|Primary|Overall Survival|Overall survival data will be reported on a 3-month basis for 5 years|Up to 5 years||||months||95% Confidence Interval|Median
1293356|NCT00098371|Primary|Progression-free Survival for All Patients as Assessed Using Standard Kaplan-Meier Methods|PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT were censored at the time of transplantation.|Up to 5 years||||months||95% Confidence Interval|Median
1293357|NCT00098371|Primary|Progression-free Survival (PFS) for Responding Patients as Assessed Using Standard Kaplan-Meier Methods|PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT (Stem cell transplantation) were censored at the time of transplantation.|Up to 5 years||||months||95% Confidence Interval|Median
1293358|NCT00098371|Primary|Response Duration|Response evaluation criteria based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response. Descriptive statistics will be computed (median, range, mean, standard deviation, minimum, and maximum) on response duration.|Up to 8 months|Duration of response was not collected for patients.||||||
1293359|NCT00098371|Primary|Overall Response Rate (CR + PR)|CR requires all of the following: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. Patients with CR after induction but wih treatment-related persistent cytopenia is a PR. PR requires a > 50% decrease in peripheral lymphocyte count from pretreatment value, > 50% reduction in lymphadenopathy, and/or > 50% reduction in splenomegaly/hepatomegaly. These patients must have one of the following: polymorphonuclear leukocytes > 1,500/μL , platelets > 100,000/μL, hemoglobin > 11.0 g/dl (untransfused) or any with 50% improvement from pretreatment value.|Up to 8 months|Schedule was amended (cycle length) from 42 to 28 days, reduction in the number of doses per cycle from 4 to 3 and administration of prophylactic dexamethasone 20 mg IV on each treatment day.|||percent of patients||95% Confidence Interval|Number
1293360|NCT00098371|Primary|Complete Response (CR) Rate|CR requires all of the following for at least two months from completion of therapy: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC (complete blood count) as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent.|Up to 8 months|Patients were assessed for clinical response after two, four and six cycles.|||percent of patients|||Number
1293361|NCT00098345|Secondary|World Health Organisation (WHO) Performance Status|Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)|Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.||||Participants|||Number
1293362|NCT00098345|Secondary|Symptomatic Response|Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.|Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.||||Participants|||Number
1293363|NCT00098345|Secondary|Biochemical Response Calcitonin (CTN)|A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).|Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation||||Participants|||Number
1293364|NCT00098345|Secondary|Disease Control Rate|Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.||||Participants|||Number
1293365|NCT00098345|Secondary|Duration of Objective Response|Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.||||days||95% Confidence Interval|Median
1293366|NCT00098345|Secondary|Progression Free Survival|Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|Upper limit is a censored value|||months||Full Range|Median
1293367|NCT00098345|Primary|Objective Response Rate|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.||||Participants|||Number
1293368|NCT00098306|Secondary|Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.|Baseline, Week 24 and Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm at particular time-point. LOCF was used to impute missing values.|||log10copies/mL||Standard Deviation|Mean
1293369|NCT00098306|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through week 48|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
1293370|NCT00098306|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through week 24|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
1293371|NCT00098306|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug ‘sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through week 48|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.|||participants|||Number
1293471|NCT00097500|Secondary|Change in Fasting Plasma Glucose|Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).|0 weeks and 52 weeks|Intent to treat population. Last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
1293372|NCT00098306|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug ‘sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through week 24|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.|||participants|||Number
1293373|NCT00098306|Secondary|Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening|FAS included all the randomized participants who had taken at least one dose of the study medication.|||participants|||Number
1293374|NCT00098306|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization and immediately pre-dose.|Baseline and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 48 have been imputed as the baseline value for participants who discontinued and as LOCF for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
1293375|NCT00098306|Secondary|Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline to Week 24 and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
1293376|NCT00098306|Secondary|Time to Virological Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication.|||days||95% Confidence Interval|Median
1293377|NCT00098306|Secondary|Change From Baseline in CD8 Cell Count at Week 24 and 48|Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/µL||Standard Error|Least Squares Mean
1293378|NCT00098306|Secondary|Change From Baseline in CD4 Cell Count at Week 24 and 48|Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/µL||Standard Error|Least Squares Mean
1293379|NCT00098306|Secondary|Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||cells per microliter (cells/µL)||Standard Deviation|Mean
1293380|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels."|||percentage of participants|||Number
1293381|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 1.0 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels."|||percentage of participants|||Number
1293382|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 0.5 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels."|||percentage of participants|||Number
1293383|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels."|||percentage of participants|||Number
1293384|NCT00098306|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 24|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 24 have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
1293385|NCT00098306|Primary|Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline|Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.|||log10 copies/milliliter(log10 copies/mL)||Standard Deviation|Mean
1293386|NCT00098293|Post-Hoc|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants|Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.|Week 96|FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
1293387|NCT00098293|Post-Hoc|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants|Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.|Week 48|FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
1293388|NCT00098293|Other Pre-specified|Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96||Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
1293389|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Baseline, Week 48, Week 96|Data not analyzed because of insufficient diversity amongst participants with respect to baseline resistance due to the study entry criteria regarding baseline resistance.||||||
1293390|NCT00098293|Secondary|Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96|Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L).|Screening, time of failure through Week 48, Week 96|FAS population; n=participants with treatment failure at specified time points for each arm group respectively. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination focus shifted from efficacy, safety to only safety as reflected in abbreviated set of efficacy noted in amended planned analysis.|||participants|||Number
1293391|NCT00098293|Secondary|Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96|Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations.|Screening, time of failure through Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘n’ is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively.|||participants|||Number
1293392|NCT00098293|Secondary|Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96|Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized.|Screening, time of failure through Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘n’ is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively.|||participants|||Number
1293393|NCT00098293|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96|Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment.|Baseline, time of failure through Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
1293394|NCT00098293|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment.|Baseline, time of failure through Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
1293395|NCT00098293|Secondary|Time to Virologic Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48, Week 96|FAS population; Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|||days||95% Confidence Interval|Median
1293396|NCT00098293|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96|Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Baseline, Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/µL||Standard Deviation|Mean
1293397|NCT00098293|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96|Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells per microliter (cells/µL)||Standard Deviation|Mean
1293398|NCT00098293|Secondary|Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Baseline up to Week 48 and Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. TAD imputed as 0 for participants who discontinued. TAD calculated using the last non-missing value prior to the analysis time point for participants with a missing value at the analysis time point but who had not discontinued.|||log10 copies/mL||Standard Error|Least Squares Mean
1293399|NCT00098293|Secondary|Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline, Week 48, Week 96|FAS population. Missing values for viral load at week 48 and 96 were imputed as baseline value for participants who discontinued and as last observation carried forward (LOCF) for participants who did not discontinue for maraviroc twice daily and efavirenz once daily arm and as LOCF for participants randomized to maraviroc once daily arm.|||log10 copies/mL||Standard Deviation|Mean
1293400|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression||Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
1293401|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression||Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
1293472|NCT00097500|Secondary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).|Week 0 and week 52|Intent to treat population. Last observation carried forward.|||percent||Standard Error|Least Squares Mean
1293402|NCT00098293|Primary|Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population|Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Week 48|Per protocol (PP) population included all randomized participants who had taken at least 1 dose of study medication, were treated for at least 14 days or discontinued before this time due to treatment failure, were >80% compliant with randomized treatment and had no violation of any inclusion or exclusion criteria, which affected efficacy. MD=F.|||Percentage of participants|||Number
1293403|NCT00098293|Primary|Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population||Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
1293404|NCT00098254|Secondary|Secondary Pharmacoproteomic Modulation Targets|Secondary pharmacoproteomic modulation targets (mTOR, EGFR, Src, NFkB, STAT1, TGFa, p38, Jak 1, lkB, IGFR, p-mTOR, p-EGFR, p-Src, p-NFkB, p-STAT1, Phospho-p38, p-Jak1, p-lkB,Pyk2, p-Pyk2, VEGFR-2, GSK3beta, p-GSK3beta, p-bad, p-Bcl-2, PCNA, Fos, Raf, CREB, Rho, avbeta3complex, Bad, CD34, VEGFR-1, bfGF, vWF, Factor VIII, Annexin V, Bcl-2).|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||mg/ml|||Number
1293405|NCT00098254|Secondary|Percent of Pts With Primary Pharmacoproteomic Modulation Targets|Pharmacoproteomic modulation targets (AKT, p-AKT, ERK 1/2, MEK, Cyclin D, p-ERK 1/2, p-MEK, pMEK, eNOA, p-eNOA, Cleaved PARP, PDGFRbeta, p-PDGFRbeta,Cyclin D, CD31, PARP. Caspase 9, Caspase 3, Cleaved Caspase-9 Cleaved Caspase 3)|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||mg/ml|||Number
1293406|NCT00098254|Secondary|Percentage of Participants With BRAF Mutations|Extracted DNA was subjected to an initial PCR using a single primer set encompassing codom V600. Pyrosequencing was carried out on a Qiagen PyroMaark Q24 system.|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||Percent of participants|||Number
1293407|NCT00098254|Secondary|Percent of Participants Who Had Cytokine Profiling for IL-6 and IL-8|Serial plasma samples were collected from all patients at pretreatment (baseline - day 0), and on days 14, 28, and 54. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||Percent of participants|||Number
1293408|NCT00098254|Secondary|Percent of Participants Who Had Immunohistochemical Analysis Performed for Raf, MEK, ERK, ERK-1 and p90RSK,ERK, E Twenty-six (ETS)-Like Transcription Factor 1 (ELK-1) and p90Ribosomal S6 Kinase (p90RSK).|Immunohistochemical analysis performed by using state specific antibodies against Raf, methyl ethyl ketone (MEK), extracellular-signal regulated kinase (ERK), and two downstream substrates of ERK, E twenty-six (ETS)-like transcription factor 1 (ELK-1) and p90Ribosomal S6 kinase (p90RSK).|59 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to br more important.|||Percent of participants|||Number
1293409|NCT00098254|Secondary|Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)|DCE-MRI was used to evaluate changes (e.g. decrease/increase in Ve, Ktrans, Kep value) in vascularity and quality of index lesions to provide early indication of treatment effect before changes in size can be perceived on CT. Changes were reflected in a decrease/increase of Ve, Ktrans, or Kep (Kep, Ve, Ktrans measurements at day 0, day 14 and the difference between the day 14 and the day 0 measurements (day 14-day 0).|59 months||||Percentage of participants|||Number
1293410|NCT00098254|Secondary|Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)|Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).|17 months||||months||95% Confidence Interval|Median
1293411|NCT00098254|Secondary|Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)|Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).|42 months|14 patients with day 28 FGF >6 and 14 patients with FGF <6.|||months||95% Confidence Interval|Median
1293412|NCT00098254|Secondary|Correlation of Response to Treatment With KRAS Mutational Status|Mutational analysis of these genes was performed on paraffin-imbedded tissue blocks from prior pathologic specimens. Disease control rate was correlated with KRAS mutational status. Disease control rate was defined as complete remission (CR) + partial remission (PR)+ stable disease (SD).|42 months|11/34 KRAS positive; 23/34 KRAS negative 5/23 EGFR positive; 18/23 EGFR negative|||percentage of participants|||Number
1293413|NCT00098254|Secondary|Cytokine Levels|Serial plasma samples were collected from all patients and cytokine levels were measured. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).|54 days||||pg/ml||Inter-Quartile Range|Median
1293414|NCT00098254|Secondary|Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml|Difference in placental derived growth factor (PLGF) between day 28 and day 0 of < 11 pg/ml vs. > 12 pg/ml.|17 months||||months||95% Confidence Interval|Median
1293415|NCT00098254|Secondary|Percent of Participants With Genotyping of CYP3A4/5 and 5 Polymorphisms|All patients will be genotyped for CYP3A4/5 and 5 polymorphisms.|58 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||Percent of participants|||Number
1293416|NCT00098254|Secondary|Overall Survival|Time between the first day of treatment to the days of death.|17 months||||months||95% Confidence Interval|Median
1293419|NCT00098254|Primary|Response Rate|Percentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired.|17 months||||percentage of participants||95% Confidence Interval|Number
1293420|NCT00098059|Primary|Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.|A patient with multiple AEs within the primary system organ class is counted only once in total row.|Administered 2 times daily over 7 days|Includes 47 patients enrolled in Part B of the study.|||participants|||Number
1293421|NCT00098059|Primary|Apparent Terminal Elimination Half-life of Penciclovir (T1/2)|PK parameter; penciclovir is the active metabolite of famciclovir|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.|||hours||Full Range|Mean
1293422|NCT00098059|Primary|Apparent Oral Clearance of Penciclovir (CL/F)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.|||L/h||Full Range|Mean
1293423|NCT00098059|Primary|Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.|||(μg/mL)h||Full Range|Mean
1293424|NCT00098059|Primary|Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes all 27 patients enrolled in Part A of the study.|||hours||Full Range|Median
1293425|NCT00098059|Primary|Maximum Observed Plasma Concentration of Penciclovir (Cmax)|PK parameter; penciclovir is the active metabolite of famciclovir.|plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes all 27 patients enrolled in Part A of the study.|||μg/mL||Full Range|Mean
1293426|NCT00098059|Primary|Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.|A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.|8 hours and 24 hours after study drug administration (Part A)|Includes all 27 patients enrolled in Part A of the study.|||participants|||Number
1293427|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study|Overall acceptability of study medication was determined by caretaker response.|Day 8 at home: after swallowing last dose|Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to <6 years and 6 to <=12 years groups.|||participants|||Number
1293428|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.|Overall acceptability of the study medication was determined by caretaker response.|Day 1 at clinic: after swallowing first dose|Includes all 47 patients enrolled in Part B of the study.|||participants|||Number
1293429|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.|Overall acceptability of the study medication was determined by caretaker response.|Day 1, after swallowing the dose.|Includes all 27 patients enrolled in Part A of the study.|||participants|||Number
1293430|NCT00098020|Secondary|Number of Patients Who Are in Complete Remission (CR) or Partial Remission (PR) at 6 Months or at the End of One Year.|Based on 24hour proteinuria, response outcomes are defined as CR (complete remission): <0.3 g/g PR (partial remission): 50% fall from baseline and <2.0 g/g|End of one year from baseline|Seven out of 8 subjects who were treated with isotretinoin completed Week 24. One out of the 7 subjected who completed Week 24 did not complete the whole study.|||Participants|||Count of Participants
1293431|NCT00098020|Primary|Change in Proteinuria at Week 24 From Baseline|Change of proteinuria at Week 24 compared to the baseline using protein/creatinine ratio (PCR)|Baseline and Week 24|A total of 7 patients is analyzed due to 1 withdrawal.|||g/g||Standard Deviation|Mean
1293432|NCT00097981|Secondary|Engraftment: Number of Participants Who Underwent Engraftment|Engraftment is the process of transplanted stem cells reproducing new cells.|From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation.|||Participants|||Number
1293433|NCT00097981|Secondary|Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)||From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.|||Participants|||Number
1293434|NCT00097981|Secondary|Overall Survival: Number of Participants Died Due to Any Cause||From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.|||Participants|||Number
1293435|NCT00097981|Secondary|Time to Progression|Time to progression is the interval between the date of randomization until disease progression or death due to progression.|From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.|||Days||95% Confidence Interval|Median
1293436|NCT00097981|Secondary|Time to 1st Response|Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.|||Days||95% Confidence Interval|Median
1293573|NCT00096109|Primary|Progression Free Survival (PFS)|PFS is defined as either progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 7 years||||months||95% Confidence Interval|Median
1293437|NCT00097981|Secondary|Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)|Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.|||Participants|||Number
1293438|NCT00097981|Primary|Complete Response Rate: Number of Participants Who Achieved a Complete Response|Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.|||Participants|||Number
1293439|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide|The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|Mean patient duration of 5.8 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
1293440|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide|The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.|Mean patient duration of 5.6 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
1293441|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide|Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.|Mean patient duration of 4.2 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
1293442|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan|The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|Mean patient duration of 5.8 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
1293443|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan|The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.|Mean patient duration of 5.6 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
1293444|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan|Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.|Mean patient duration of 4.2 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
1293445|NCT00097773|Secondary|Number of Participants With a Pulmonary Exacerbation Requiring Oral, Inhaled, or Oral Antibiotics|"The primary comparison is between the pooled culture-based group and the pooled cycled group. No interactions with ciprofloxacin were identified. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.~Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns."|Measured over the 18 month time period|Intent to treat|||participants|||Number
1293446|NCT00097773|Secondary|Proportion of Participants With a Pa Positive Culture|"Proportion of participants with a Pa positive culture compared between (1) the pooled cycled therapy group (n=152) and pooled culture-based therapy group (n=152), and (2) between the pooled oral placebo (n=152)and pooled cipro groups (n=152).~Participants are included once in the cycled and culture-based columns, and once in the oral cipro and placebo columns"|Week 10 (after initial treatment course for Pa) through Month 18|Intent to treat|||Participants|||Number
1293447|NCT00097773|Primary|Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization|"The primary comparison is between the pooled culture-based group and the pooled cycled group. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.~Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns."|Measured over the 18 month study|Intent to treat|||number of participants|||Number
1293574|NCT00096109|Primary|Response Rate (Complete Response (CR) +Partial Response (PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 7 years||||Participants|||Count of Participants
1293448|NCT00097721|Secondary|Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores|The FACT-B questionnaire consists of 36 questions each scored from 0-4. The total score is calculated by summing these scores. The total possible range is from 0 to 144. The higher scores indicate a better health-related quality of life. This measures emotional, functional, physical, and social well being as well as concerns specific to patients with breast cancer.|At Screening, Day 1 of each cycle, and 30 days after last dose of study drug||||units on a scale||Full Range|Median
1293449|NCT00097721|Secondary|Overall Survival|Defined as the time from the start of study drug administration until death from any cause|From start of study drug administration to death|Per Protocol Population (Investigator Assessment)|||days||Full Range|Median
1293450|NCT00097721|Secondary|Progression Free Survival|Defined as the time from start of study drug administration until progressive disease or death from any cause during the study period in the absence of disease progression.|From start of study drug administration to progressive disease or death|Per Protocol Population (Investigator Assessment)|||days||Full Range|Median
1293451|NCT00097721|Secondary|Duration of Response|Measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent progressive disease was objectively documented (taking as a reference for progressive disease the smallest measurements recorded since the treatment started).|From CR or partial response PR (whichever recorded first) to date of recurrent or progressive disease|Intent to Treat/Safety Population (Investigator Assessment)|||days||Full Range|Median
1293452|NCT00097721|Primary|Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Confirmed 4 to 8 weeks after first observed|Per Protocol Population (Independent Reviewer Assessment)|||percentage of participants|||Number
1293453|NCT00097708|Primary|Change in HAM-A Total Score|Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.|Baseline to week 8||||Units on a Scale||Full Range|Least Squares Mean
1293454|NCT00097695|Secondary|Time to Almost Complete Symptom Relief|The time to almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least 3 consecutive measurements for all symptom.|5 days||||Hours||Inter-Quartile Range|Median
1293455|NCT00097695|Secondary|Time to Regression (Start of Improvement) According to Patient|"This parameter assessed the time to regression (start of improvement) of observable(visible) symptoms according to the patients. Patients were asked Report date and time when you feel that your symptoms start to improve."|5 days||||Hours||Inter-Quartile Range|Median
1293456|NCT00097695|Primary|Time to Onset of Symptom Relief (TOSR)|"The primary efficacy endpoint was TOSR assessed by the patient using a Visual Analogue Scale (VAS). The VAS is a scale used to measure intensity of each symptom of the attack at baseline and at the pre-determined time points throughout treatment period. It consists of a horizontal 10cm line, with the 0 point corresponding to a state where patient experiences no symptoms at all and the 10cm point represents the worst symptoms ever experienced by patient. The patient indicates his/her current state of symptoms by drawing a mark across the horizontal line.~TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the 3 primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.~The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe."|5 days|Time to onset of symptom relief - Controlled phase - ITT population (patients experiencing moderate to very severe acute cutaneous and/or abdominal HAE attacks)|||Hours||Inter-Quartile Range|Median
1293457|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population.|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.|||Participants|||Number
1293458|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events|The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population.|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.|||Participants|||Number
1293459|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods.|Randomization to 30 days; randomization to 90 days|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.|||Participants|||Number
1293460|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)|The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods.|Randomization to 30 days; randomization to 90 days|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.|||Participants|||Number
1293575|NCT00096044|Secondary|Time to Progression for the Combination Therapy of CC-5013+Rituximab|Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.|Every month up to 6 months and every 3 months thereafter up to 5 years|All treated with combination therapy of CC-5013+Rituximab and eligible patients|||months||95% Confidence Interval|Median
1293461|NCT00097591|Secondary|Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events|TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal.|First dose of study drug up to 15 months (while at risk)|Treated subjects with adverse events were considered “at risk” from the first dose of study drug up through 7 days after permanent study drug discontinuation, or the subjects’ discontinuation visit; or from randomization through 464 days, whichever is earlier. Adverse events classified as “study drug related” were included in the “at risk” set.|||Participants|||Number
1293462|NCT00097591|Primary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) who may or may not have received study drug|||Participants|||Number
1293463|NCT00097539|Primary|Near Adult Height (NAH)|Heights were standardized with height standardized deviation scores (SDS) to enable height comparisons across ages and sexes using methods and height standards found at: http://www.cdc.gov/growthcharts/cdc_charts.htm. NAH were calculated overall and by etiology groups for participants who had both a non-missing value available height z-score and a non-missing enrollment height (EH) SDS, as well as for participants with 3 or more years of GH therapy (GHT ≥3y).|From October 1985 to June 2010 (overall approximately 24 years and 9 months)|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.|||SDS||Standard Deviation|Mean
1293464|NCT00097539|Primary|Third Year Annualized Growth Rate|Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 730 days after baseline to the visit closest to 1095 days. Visits within 90 days of 730 and 1095 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 730 or 1095 days was used. Growth rates <-1 or >30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing third-year growth rate data were included in the analysis.|Year 3|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.|||cm/yr||Standard Deviation|Mean
1293465|NCT00097539|Primary|Second Year Annualized Growth Rate|Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 365 days after baseline to the visit closest to 730 days. Visits within 90 days of 365 and 730 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365 or 730 days was used. Growth rates <-1 or >30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing second-year growth rate data were included in the analysis.|Year 2|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.|||cm/yr||Standard Deviation|Mean
1293466|NCT00097539|Primary|First Year Annualized Growth Rate|Annualized growth rates are expressed as centimeters per year (cm/yr), computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the first injection (baseline/ enrollment) to the visit closest to 365*1 days after baseline. Visits within 90 days of 365*1 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365*1 days was used. Growth rates less than (<) -1 or greater than (>) 30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing 1-year growth rate data were included in the analysis.|Year 1|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.|||cm/yr||Standard Deviation|Mean
1293467|NCT00097539|Primary|Number of Participants Who Died||From October 1985 to June 2010 (overall approximately 24 years and 9 months)|Safety evaluable population|||participants|||Number
1293468|NCT00097500|Secondary|M-value at Baseline, Week 52 and Week 56|M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.|baseline (week -2), 52 weeks, and 56 weeks|Evaluable population.|||mg/min/kg||Standard Error|Mean
1293469|NCT00097500|Secondary|Change in Body Weight|Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).|0 weeks and 52 weeks|Intent to treat population. Last observation carried forward.|||kg||Standard Error|Least Squares Mean
1293470|NCT00097500|Secondary|Seven Point Self Monitored Blood Glucose (SMBG) Measurements|SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).|0 weeks and 52 weeks|Intent to treat population.|||mmol/L||Standard Deviation|Mean
1293666|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 1|Laboratory hematology hemoglobin|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||g/L||Standard Deviation|Mean
1293473|NCT00097500|Secondary|Change in Second Phase C-peptide Release|Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.|baseline (-2 weeks), 52 weeks, and 56 weeks|Evaluable population. Last observation carried forward.|||ratio||Standard Error|Least Squares Mean
1293474|NCT00097500|Secondary|Change in First Phase C-peptide Release|Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.|baseline (week -2), 52 weeks, and 56 weeks|Evaluable population. Last observation carried forward.|||ratio||Standard Error|Least Squares Mean
1293475|NCT00097500|Secondary|Beta-cell Function 4 Weeks After Cessation of Therapy|Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]).|Baseline (week -2) and 56 weeks|Evaluable population|||ratio||Standard Error|Least Squares Mean
1293476|NCT00097500|Primary|Beta-cell Function After 52 Weeks of Therapy|Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]).|Baseline (week -2) and 52 weeks|Evaluable population|||ratio||Standard Error|Least Squares Mean
1293477|NCT00097448|Primary|Hearing Improvement|Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.|2 months|Intention-to-treat|||dB||Standard Deviation|Mean
1293478|NCT00097370|Secondary|Change From Baseline in QoL and Current Health Status: Mental Summary Score of the SF12 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey developed by the Medical Outcomes Trust and QualityMetric Incorporated. It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 scale questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health are for mental component summary. Transformed mental component summary score (MCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
1293479|NCT00097370|Secondary|Change From Baseline in Quality of Life (QoL) and Current Health Status: Physical Summary Score of the Study Short Form Health Survey (SF-12) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey . It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on the scale||Standard Deviation|Mean
1293480|NCT00097370|Secondary|Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The erythema subscale score and edema subscale score are each graded on a 0-3 scale, with 0 = absent , 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 6, with higher scores indicative of more severe Erythema/Edema. The total score was obtained by summing together the responses for each of the two subscale items. Change from Baseline in erythema/edema total score is the difference between erythema/edema total score at the time point being analyzed to the MHE100901 Baseline score..|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
1293481|NCT00097370|Secondary|Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The pruritus visual analogue scale asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0-100 with 0 = No itch and 100 = Worst imaginable itch. Change from Baseline in pVAS score is the difference between the pVAS score at the time point being considered to the MHE100901 Baseline score.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on the scale||Standard Deviation|Mean
1293482|NCT00097370|Secondary|Number of Participants by Dosing Frequency Groups (Defined as Two Week Dosing Ranges Greater Than a 4 Week Interval) at the End of Stage 2|The number of participants at the end of Stage 2 with study medication dosing frequencies of 4 weeks, 5-6 weeks, 7-8 weeks, 9-10 weeks, 11-12 weeks, 13-16 weeks, 17-20 weeks, 21-24 weeks and >24 weeks were summarized. The first infusion date in Stage 3 and the last infusion date in Stage 2 were used to calculate the dosing frequency.|up to approximately 6 years|ITT Population. Only those participants available at end of Stage 2 were included.|||Participants|||Number
1293483|NCT00097370|Secondary|Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3|Mean blood eosinophil counts were summarized over time taking into account the effect of HES background therapy. Eosinophil count observations for only those participants taking mepolizumab in conjunction with prednisone or as monotherapy were included.|up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Cell/uL||Standard Deviation|Mean
1293484|NCT00097370|Secondary|For Those Participants Who Entered Stage 1 From Study MHE100185 With >10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for>=3 Months|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of >10 mg prednisone at the end of the study and participants who withdrew from the study early who were at a prednisone dose level >10 mg were analyzed. Duration of doses <= 10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they do not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months)|up to approximately 6 years|ITT Population. Only those participants who entered Stage 1 from study MHE100185 with >10 mg prednisone were analyzed.|||Participants|||Number
1293485|NCT00097370|Secondary|For Those Participants Who Entered Stage 2 From Study MHE100185 With a Prednisone Level of <=10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for >=3 Months;|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end and participants who withdrew from the study early who were at a prednisone dose level <=10 mg were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overlap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).|up to approximately 6 years|ITT Population. Only those participants who entered Stage 2 from study MHE100185 with a prednisone level of <=10 mg prednisone were analyzed.|||Participants|||Number
1293486|NCT00097370|Secondary|For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level >10 mg: Number of Participants Achieving <=10 mg Prednisone (as Sole Background Therapy) for >= 8 Weeks|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of prednisone of >10 mg at the end of the study were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 53 days (8 weeks).|up to approximately 6 years|ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level >10 mg were analyzed.|||Participants|||Number
1293487|NCT00097370|Secondary|For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level <=10 mg: Number of Participants Achieving <= 10 mg Prednisone (as Sole Background Therapy) for >= 3months|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end were analyzed. Duration of doses <=10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).|up to approximately 6 years|ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level <=10 mg were analyzed.|||Participants|||Number
1293488|NCT00097370|Secondary|Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study|The criteria for eosinophil count was achieved if the participant's eosinophil count remained below <600 cell/uL for the last observation on study i.e. within length of dosing cycle + 7 days of last dose of study drug. For participants who entered in Stage 1, HES medications taking prior to the first infusion date in Stage 2 were considered as the lowest background therapy. For participants who entered in Stage 2, HES medications taken on the date that immediately preceded the first infusion date of study drug and had not been discontinued was regarded as the lowest background therapy. If the dose of the lowest background therapy had increased or the medication had changed or the participant had not reached their lowest background therapy, the participant was regarded as not achieving this endpoint.|up to approximately 6 years|ITT Population|||Participants|||Number
1293489|NCT00097370|Secondary|Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study|Participants who were receiving a prednisone dose level of =<10 mg as their sole background therapy at the end of the study were included for the analysis.|up to approximately 6 years|ITT Population|||Participants|||Number
1293490|NCT00097370|Primary|Number of Participants With Any Adverse Event (AE) During the Follow-up Phase|An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Follow-up phase. Safety and tolerability of the study drug was assessed by number of participants with any AE|From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)|Follow-up Population: subset of the modified ITT Population who had evidence of being in the study > length of dosing cycle + 7 days after the date of their last dose of study medication and up to and including 97 days after their last dose date.|||Participants|||Number
1293491|NCT00097370|Primary|Number of Participants With Any Adverse Event (AE) During the Treatment Phase|An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE|From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)|Intent-to-Treat (ITT) Population: all enrolled participants who received at least one dose of mepolizumab in this study.|||Participants|||Number
1293492|NCT00097253|Primary|Immune Function: Delayed Hypersensitivity to Candida(DTH)|DTH memory responses to a common infectious agent provided a measure of T-cell immunity. Nurses inoculated subject's arm with 0.1ml Candida (stock solution diluted 1:20 in saline, Greer Labs, NC) intradermally, after the cold pressor stressor. The wheal diameter (2 dimensions) was self-assessed at 24, 48, and 72 hours by participants given detailed instructions and templates for measurement.|Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.||||mm^2||Standard Deviation|Mean
1293493|NCT00097253|Primary|Skin Barrier Repair|TEWL (Transepidermal Water Loss, via tape stripping procedure)measured before and after cold pressor stressor (11:00). After obtaining baseline measurements on volar forearm, cellophane tape(3M Scotch-type; St. Paul, MN) was applied repeatedly (6–50 times) to remove superficial layer of cornified skin cells. Tape stripping stopped when TEWL was elevated from the basal level of 5–7 g/h/m2 to at least 20 g/h/m2. The number of strips required to reach TEWL X20 g/m2/h was the measure of barrier. TEWL was measured with a computerized evaporimetry instrument, the DermaLabs (CyberDERM, Media, PA).|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4).10:05, 11:45, 13:15||||number tape strips||Standard Deviation|Mean
1293494|NCT00097253|Primary|Immune Function|Stimulated Cytokine Production (Interleukin-6 (IL-6), Interleukin-10 (IL-10)) measured before and after cold pressor stressor, which occurred at 11:00.|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). 9:05, 10:05, 11:45||||pg/ml||Standard Deviation|Mean
1293495|NCT00097253|Primary|Cortisol and Catecholamine Production|Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). Cortisol: 9:05, 10:05, 10:55, 11:45, 12:15, 13:00. Nor/Epi: 9:05, 10:05, 10:55, 11:05, 11:45, 12:15||||pg/ml (log 10)||Standard Deviation|Mean
1293496|NCT00096993|Secondary|Duration of Survival|Duration of survival was defined as the time from randomization until death from any cause.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
1293497|NCT00096993|Secondary|Percentage of Participants Free From Disease Progression at 4 Months|Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to Month 4|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1293498|NCT00096993|Secondary|Duration of the Objective Response|Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. Only participants with an objective response were included in the analysis.|||months||95% Confidence Interval|Median
1293499|NCT00096993|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1293500|NCT00096993|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
1293501|NCT00096954|Secondary|Relative Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24|"Spirometry was used to assess FEV1. All spirometry measurements were performed in accordance with the American Thoracic Society (ATS) guidelines.~The relative percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was calculated at week 24 using the formula: (FEV1 at week 24 - FEV1 at baseline) / FEV1 at baseline * 100 for each treatment group."|Baseline and 24 weeks|Modified Intent-to-Treat. Patients with missing FEV1 data at either baseline or week 24 were excluded.|||percent change||Standard Deviation|Mean
1293502|NCT00096954|Secondary|Change From Baseline in Nocturnal and Daytime Asthma Symptom Scores at Week 24|"The daytime asthma symptom score assessed the symptoms: shortness of breath, chest discomfort, wheezing, and cough over the previous 24 hour period on a scale of 0(no symptoms) to 4(marked discomfort).~The nocturnal asthma score was the patient's response to:How did you sleep last night? rated on a scale of 0(no problems) to 4(difficulty sleeping;rescue medicine used).~Scores were collected daily. Change from Baseline (mean of last 28 days prior to first dosing date) at Week 24 (mean of last 28 days prior to week 24 visit).~A negative change from baseline score indicates improvement."|Baseline and 24 weeks|Modified Intent-to-Treat. Patients with missing Asthma Symptom Score data at week 24 were excluded.|||score on a scale||Standard Deviation|Mean
1293503|NCT00096954|Secondary|Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period|The number of patients reporting one or more protocol-defined asthma exacerbations during the 24 week treatment period. A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.|Start of treatment to 24 weeks|Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).|||participants|||Number
1293504|NCT00096954|Primary|Rate of Asthma Exacerbations Over the 24 Week Treatment Period|"A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.~The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 week treatment period in each treatment group."|Start of treatment to 24 weeks|Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).|||exacerbations per 24 patient-week period|||Number
1293505|NCT00096941|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 2 years, 5 months)|Safety population: Participants who received at least 1 dose of pertuzumab.|||percentage of participants|||Number
1293506|NCT00096941|Primary|Percentage of Participants Who Experienced an Adverse Event||Baseline to the end of the study (up to 2 years, 5 months)|Safety population: Participants who received at least 1 dose of pertuzumab. Percentage of participants|||percentage of participants|||Number
1293507|NCT00096785|Secondary|Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs|Laboratory abnormalities reported as clinical AEs|Week 48|As-treated population. 1 participant who was randomized to ADV, but treated with ETV was counted in the ETV group.|||Participants|||Number
1293508|NCT00096785|Secondary|Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths|AE=new untoward medical occurrence or worsening of pre-existing medical condition regardless of causal relationship to treatment. SAE=untoward medical occurrence that is life-threatening, a congenital anomaly/birth defect, or an important medical event, or results in death, inpatient hospitalization/prolongation of hospitalization, or persistent/significant disability. AE grades: mild (1), moderate (2), severe (3), life-threatening (4), death (5). ALT flare= >2x baseline & >10x ULN up to end of therapy + 5 days. Hepatic SAE=SAEs consistent with worsening of hepatitis or hepatic decompensation.|cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset|As-treated population. 1 participant was randomized to ADV, but treated with ETV was counted in the ETV group.|||Participants|||Number
1293509|NCT00096785|Secondary|HBV DNA Viral Kinetics - Spline Model|This analysis uses a 3-parameter piece-wise linear model and describes the biphasic decline in HBV DNA (measured by PCR assay) through Week 12. The 3 parameters are the values for the 2 slopes, describing the first and second phase declines, respectively, and the estimated HBV DNA at the knot (at day 10; the time point where the 2 phases join). The biphasic viral decay kinetics for each treatment were obtained using a spline fitting procedure to estimate the 3 parameters for each subject; these estimates were then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||log10 copies/mL|||Number
1293510|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. An important derived parameter is the half-life of free virus (ie, the average amount of time for HBV particles in plasma to be reduced to half the initial level), calculated as 24*ln(2)/c. The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||hours|||Number
1293511|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the clearance rate of the free virus (c), the death rate of productively infected cells (δ), The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||per day|||Number
1293576|NCT00096044|Secondary|Time to Progression for Single Agent CC-5013|Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.|5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1293577|NCT00096044|Secondary|Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab|Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0|Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.|All treated with combination therapy of CC-5013+Rituximab and eligible patients|||Participants|||Count of Participants
1293512|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε) and effectiveness of the study treatment in blocking de novo infection of susceptible cells (η). The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||percent effective|||Number
1293513|NCT00096785|Secondary|Alanine Aminotransferase (ALT) Normalization|Number of participants with ALT ≤ 1 x upper limit of normal (ULN)|Week 48|treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||participants|||Number
1293514|NCT00096785|Secondary|Viral Load Undetectable (HBV DNA <300 Copies/mL)|Number of Subjects with HBV DNA <300 copies/mL by Roche COBAS® Amplicor (limit of quantitation 300 copies/mL)|Week 48|Treated participants who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||Participants|||Number
1293515|NCT00096785|Secondary|Change From Baseline in HBV DNA by PCR Assay at Week 48|Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 48, adjusted for baseline (Week 48 - Baseline). A negative value = improvement.|Baseline, Week 48|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||log10 c/mL||Standard Error|Mean
1293516|NCT00096785|Primary|Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12|Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.|Baseline, Week 12|As-randomized participants who completed 12 weeks of treatment|||log10 copies/mL||Standard Error|Mean
1293517|NCT00096681|Secondary|Number of Participants With a Positive HIV Test|Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit.|HIV status at the time of the study visit||||Participants|||Number
1293518|NCT00096681|Primary|Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis|Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.|Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit||||Participants|||Number
1293519|NCT00096538|Primary|Tumor Response Rate Every 4 Weeks||2 years||||participants|||Number
1293520|NCT00096486|Primary|Overall Objective Response|Determine efficacy of the combination oral daily gefitinib and oral daily RAD001 in patients with advanced NSCLC. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).|2 years||||participants|||Number
1293521|NCT00096460|Primary|Lymphoma Progression-free Survival||Three years post-Hematopoietic Stem Cell Transplant (HSCT)||||participants|||Number
1293522|NCT00096447|Secondary|Prognostic Factor (Histologic Grade)|G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.|Baseline|Eligible and evaluable|||Participants|||Count of Participants
1293523|NCT00096447|Secondary|Prognostic Factors (Performance Status)|"Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction.~Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work."|Baseline|Eligible and evaluable|||Participants|||Count of Participants
1293524|NCT00096447|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||Months||95% Confidence Interval|Median
1293525|NCT00096447|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and evaluable patients|||months||Inter-Quartile Range|Median
1293526|NCT00096447|Secondary|Percentage of Patients With Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1293527|NCT00096447|Primary|Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0|The frequency and severity of all toxicities are tabulated.|Every cycle during treatment and 30 days after the last cycle of therapy.|Eligible and evaluable patients|||Participants|||Count of Participants
1293578|NCT00096044|Secondary|Number of Participants With Adverse Events on Single Agent CC-5013|"Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0~Please refer to the adverse event reporting for more detail."|1 year|All treated and eligible patients|||Participants|||Count of Participants
1293528|NCT00096447|Primary|Percentage of Patients With Progression-free Survival > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1293529|NCT00096382|Primary|Safety|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years||||Participants|||Number
1293530|NCT00096382|Primary|Clinical Tumor Regression|Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.||||Participants|||Number
1293531|NCT00096356|Secondary|Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization|CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.|24 weeks||||units on a scale||Standard Error|Least Squares Mean
1293532|NCT00096356|Secondary|Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization|FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.|24 weeks||||units on a scale||Standard Error|Least Squares Mean
1293533|NCT00096356|Primary|Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization|POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.|24 weeks||||units on a scale||Standard Error|Least Squares Mean
1293534|NCT00096278|Other Pre-specified|Proteinuria After Completion of Bevacizumab||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months|||||||
1293535|NCT00096278|Other Pre-specified|Proteinuria With Clinical Sequelae||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months|||||||
1293536|NCT00096278|Other Pre-specified|The Risk Factors for Development of Proteinuria||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months|||||||
1293537|NCT00096278|Other Pre-specified|As Measured by Blood Pressure and Antihypertensive Medication Hypertension||Group 2, every 3 months for one year post treatment|Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.||||||
1293538|NCT00096278|Other Pre-specified|Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab||Events measured regularly during chemotherapy and bevacizumab therapy|Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.||||||
1293539|NCT00096278|Other Pre-specified|Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test||Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization|Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.||||||
1293540|NCT00096278|Other Pre-specified|Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab||Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy|Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.||||||
1293541|NCT00096278|Secondary|Survival|Percentage of patients who did not experience an event where events are defined as death from any cause.|5 years|Survival analysis was done 2 years after Disease Free Survival analysis. For Arm 2 one additional patient had follow up at the later analysis.|||percentage of patients|||Number
1293542|NCT00096278|Primary|Disease-free Survival|Where events are defined as recurrence, second primary cancer, or death from any cause|3 years||||percentage of patients|||Number
1293543|NCT00096265|Secondary|Cause of Death (Neurologic vs Other)|Patients were considered to have died neurologic deaths (coded as “Brain Metastases”) if they had stable systemic disease and progressive neurologic disease consisting of expanding intracranial masses, CNS hemorrhages, hydrocephalus resulting in herniation or fulminant meningeal carcinomatosis.|From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.|Eligible patients who died|||Participants|||Count of Participants
1293544|NCT00096265|Secondary|Change in Steroid Dependence at Six Months|Daily steroid dose will be collected at baseline and follow-up, as one of the following: 0-4 mg, >4 to ≤ 8 mg, >8 to ≤12 mg, and >12 mg. Change from baseline at six months will be evaluated to have decreased, remained stable, or increased, based on these categories.|From randomization to six months.|Eligible patients with both baseline and 6 month steroid dose|||Participants|||Count of Participants
1293545|NCT00096265|Secondary|Change in Performance Status at Six Months|Compared between two treatment arms using a two-group chi-squared test. Zubrod score will be collected at baseline and follow-up. The Zubrod performance score runs from 0 to 5, with 0 denoting perfect health and 5 death. Change from baseline is calculated as 6-month value - baseline value. Patients with a baseline score who have died by six months will be included in the analysis with a score of 5 at six months.|From randomization to six months.|Eligible patients with baseline and 6 month data|||Participants|||Count of Participants
1293546|NCT00096265|Secondary|Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months|The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score, which ranges from 0 to 76. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-Br including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL. A change of 5 points will be considered a minimal clinically meaningful change. Change from baseline at three months (3 month score - baseline score) will be categorized as improvement if increased, stable if no change, or deterioration if decreased.|From randomization to three months.|Eligible patients with both baseline and 3 month data|||Participants|||Count of Participants
1293547|NCT00096265|Secondary|Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument|Quality-adjusted life years (QALY) incorporate the societal-based utilities of health states into expected life years for a health condition. The QALY model is QALY(h,y) where h is a health state and y is the years of life. Higher quality-adjusted life year values represent a better outcome. A patient’s health state will be determined from the index score of the EQ-5D-5L patient questionnaire.The EQ-5D-5L is a 2-part self-assessment questionnaire, a 5-item index score and a visual analogue scale, but only the index score is used for quality-adjusted survival. The index score has 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state).|From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.|Eligible patients with any follow-up EQ-5D|||Quality-adjusted life years||Standard Deviation|Mean
1293548|NCT00096265|Secondary|Rate of CNS Progression (One Year)|CNS progression is defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression). For lesions smaller than 1 cm in maximum diameter, a maximum increase of 50% in perpendicular bi-dimensional treatment area is necessary to score as progression. This caveat is included to account for potential variability in measurement, which is most susceptible to proportionate errors at smaller sizes. For greater than 1 cm lesions, the definition uses a 25% rule for change. Rates of CNS progression estimated by the cumulative incidence method, with death treated as a competing risk.|From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.|Eligible patients|||percentage of participants||95% Confidence Interval|Number
1293549|NCT00096265|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.|From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.|All eligible patients.|||months||95% Confidence Interval|Median
1293550|NCT00096226|Secondary|Toxicity||From start of treatment to end of follow-up|||||||
1293551|NCT00096226|Secondary|Progression-free Survival||From registration to two years|||||||
1293552|NCT00096226|Secondary|Overall Survival||From registration to two years|||||||
1293553|NCT00096226|Secondary|Rates of R0, R1, and R2 Resections After Chemotherapy||At completion of concurrent chemotherapy and radiation therapy|||||||
1293554|NCT00096226|Secondary|Rate of Resectability After Chemotherapy||At completion of concurrent chemotherapy and radiation therapy|||||||
1293555|NCT00096226|Secondary|Rate of Major Morbidities Within 30 Days of Surgery||From date of surgery to 30 days following the date of surgery|||||||
1293556|NCT00096226|Secondary|Rate of Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy||At completion of concurrent chemotherapy and radiation therapy|||||||
1293557|NCT00096226|Primary|Mediastinal Nodal Clearance Rate|If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.|At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.|Eligible patients who started protocol treatment and had adequate pathologic information of mediastinal nodal status.|||participants|||Number
1293558|NCT00096200|Secondary|Overall Survival|Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.|up to 85 months of follow-up|Subjects that received at least 2 cycles of treatment|||months||95% Confidence Interval|Median
1293559|NCT00096200|Secondary|Evaluate the Progression-free Survival Rate|Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.|up to 85 months of follow-up|Subjects who completed at least 2 cycles of therapy|||months||95% Confidence Interval|Median
1293560|NCT00096200|Primary|Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.|after 6 weeks (2 cycles)|Patients that received 2 cycles of treatment. Includes results from patients that crossed over to Arm C.|||participants|||Number
1293599|NCT00095836|Secondary|Median Progression-free Survival|"The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions."|From the time of enrollment until disease progression or death, whichever came first||||Months||95% Confidence Interval|Median
1293600|NCT00095836|Secondary|Toxicity|Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients|Through study completion, on average 12 months||||participants|||Number
1293561|NCT00096174|Secondary|Overall Response Rate|Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients|assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entry|Eligible and treated|||proportion of participants||90% Confidence Interval|Number
1293562|NCT00096174|Secondary|2-year Overall Survival Rate|Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients.|assessed very 3 months for 2 years|Eligible and treated|||proportion of participants||95% Confidence Interval|Number
1293563|NCT00096174|Primary|2-year Progression-free Survival Rate|Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.|assessed every 3 months for 2 years|Eligible and treated|||proportion of participants||95% Confidence Interval|Number
1293564|NCT00096161|Secondary|Survival|Percentage patients surviving.|1 year after DLI||||percentage of participants|||Number
1293565|NCT00096161|Secondary|Incidence of Relapse/Progression|"CML Acquisition of a new cytogenetic abnormality and/or development of accelerated phase or blast crisis. Criteria for accelerated phase: unexplained fever >38.3° C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, BM blasts and promyelocytes >20%.~AML, ALL, CMML >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.~CLL Progressive disease: ≥1 of: physical exam/imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter’s transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ tx; or definite increase in the size/number of plasmacytomas or lytic bone lesions."|1 year after DLI||||percentage of participants|||Number
1293566|NCT00096161|Secondary|Incidence of Infections||100 days after DLI||||percentage of participants|||Number
1293567|NCT00096161|Secondary|Incidence of GVHD|"Percentage patients with acute or chronic GVHD.~The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD."|1 year after DLI||||percentage of participants|||Number
1293568|NCT00096161|Primary|Incidence of Grade IV Acute GVHD|"Clinical Stage of acute GVHD according to Organ System~Skin:~- Maculopapular rash <25% of body surface~- Maculopapular rash 25-50% of body surface~- Maculopapular rash >50% body surface area or generalized erythroderma~- Generalized erythroderma with bullous formation and desquamation~Liver:~- Bilirubin 2-3 mg/dl~- Bilirubin 3.1-6 mg/dl~- Bilirubin 6.1-15 mg/dl~- Bilirubin >15 mg/dl~Gut:~- >500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD~- >1000 -1500 mL diarrhea per day~- >1500 mL diarrhea per day~- >1500 mL diarrhea per day plus severe abdominal pain with or without ileus~Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI"|Within 100 days after the last DLI||||percentage of participants|||Number
1293569|NCT00096161|Primary|Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism|"A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements.~“Chimerism” in hematopoietic cell transplant derives from this idea of a “mixed” entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient’s blood cells or marrow cells."|From the time of enrollment maintained to day 56 after the last DLI, up to Day 112||||percentage of participants|||Number
1293570|NCT00096135|Primary|Event-free Survival|Monitoring of efficacy results will be performed in comparison with historical results.|3 years|The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.|||percentage of participants|||Number
1293571|NCT00096122|Primary|Number of Participants With Complete Response|Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1*10^9/L or more and platelet count of 100*10^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20*10^9/L to less than 100*10^9/L.|21 Day Cycle|Analysis was per protocol.|||Participants|||Number
1293572|NCT00096109|Primary|Her2/Neu Status|"Response rates will be estimated separately for her2/neu positive and her2/neu negative individuals along with 95% confidence intervals.~PLEASE NOTE: IT WAS PROPOSED TO ANALYZE OUTCOME BY HER2 STATUS, NO DATA WAS COLLECTED OR EVALUATED."|Baseline|No participants were evaluated for her2/neu status.||||||
1293653|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 3|Laboratory hematology total neutrophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
1293579|NCT00096044|Secondary|Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab|Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.|5 years|All treated with combination therapy of CC-5013+Rituximab and eligible patients|||percentage of participants||95% Confidence Interval|Number
1293580|NCT00096044|Primary|Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months|Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.|at 6 Months|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1293581|NCT00096031|Secondary|Time to Progression|Progression free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|every 3 weeks while on treatment, then every 3 months for 3 years||||months||95% Confidence Interval|Median
1293582|NCT00096031|Secondary|Time to Treatment Failure|Time to treatment failure is measured from date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|every 3 weeks while on treatment||||months||95% Confidence Interval|Median
1293583|NCT00096031|Primary|Overall Survival at 6 Months|Time to death is measured from date of registration to date of death due to any cause.|every 3 weeks while on treatment, then every 3 months||||percentage of participants||95% Confidence Interval|Number
1293584|NCT00096018|Primary|Duration of Response||4 weeks, every 3 months for 2 years, and then every 4 months for 2 years|Patients with Complete or Partial Response|||months||Standard Deviation|Mean
1293585|NCT00096018|Primary|Overall Responders (Complete and Partial Response)|Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)|4 weeks, every 3 months for 2 years, and then every 4 months for 2 years|All Treated Patients|||participants|||Number
1293586|NCT00095979|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated patients|||months||95% Confidence Interval|Median
1293587|NCT00095979|Secondary|Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1293588|NCT00095979|Primary|Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)||Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)|Eligible and treated patients|||Participants|||Count of Participants
1293654|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 1|Laboratory hematology total neutrophils|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
1293589|NCT00095979|Primary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1293590|NCT00095940|Secondary|Number of Participants With Tumors Expressing Phosphorylated ERBB2 (Phase II Objective)|Phosphorylated ERBB2 expression is assessed in patients who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of phosphorylated ERBB2. Low, moderate, and intense expression are combined into one group vs. no phosphorylated ERBB2 expression.|Pre-treatment|Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.|||Participants|||Number
1293591|NCT00095940|Secondary|Number of Participants With Tumors Expressing Total ERBB2|Total ERBB2 expression is assessed in participants enrolled in both the molecular biology trial and the phase II trial who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of total ERBB2. Low, moderate, and intense expression are combined into one group vs. no total ERBB2 expression.|Pre-treatment|Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.|||Participants|||Number
1293592|NCT00095940|Secondary|Maximum Concentration of Lapatinib in Plasma (Phase II Objective)|Serial plasma samples for pharmacokinetic studies of lapatinib will be collected from consenting participants with the first dose of course 1.|First dose of lapatinib in course 1|The analysis population consists of participants with recurrent medulloblastoma, high grade glioma, or ependymoma who did not have surgical resection of the tumor at study enrollment, consented to the pharmacokinetic studies, and received the first dose of lapatinib in course 1.|||nanogram/milliliter||Full Range|Median
1293593|NCT00095940|Secondary|Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective)|For participants randomized to receive lapatinib 7-14 days prior to surgery, plasma samples will be obtained with the first dose of lapatinib prior to surgery. The lapatinib concentration is measured in both the plasma samples and the tumor tissue obtained at surgery. Reported is the concentration of lapatinib observed in the tumor expressed as a percentage of the concentration observed in plasma.|First dose of lapatinib prior to surgery|The analysis population consists of recurrent medulloblastoma, high grade glioma, or ependymoma patients who were randomized to receive lapatinib prior to surgery, consented to the pharmacokinetic studies and received dose 1 of lapatinib.|||percent||Full Range|Median
1293594|NCT00095940|Primary|Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective)|A complete response is defined as complete disappearance of all tumor accompanied by a stable or improving neurologic exam, and a partial response is defined as 50% or more reduction in the tumor size by bi-dimensional measurement and a stable or improving neurologic exam. The response must be sustained for at least 8 weeks. The number of patients with a sustained objective response will be reported separately for each of the three disease groups.|From start of therapy until the earliest of disease progression, death or end of the fourth course (recurrent medulloblastoma and recurrent high grade glioma) or end of the sixth course (recurrent ependymoma)|Participants with measureable residual disease who do not receive lapatinib prior to surgery or who do not have surgical resection of the tumor at study enrollment will be assessed for sustained objective response. Participants must have received at least one dose of lapatinib and remain on treatment for the specified time frame to be evaluable.|||Participants|||Number
1293595|NCT00095940|Primary|Relative Phosphorylation of ERBB2 (Molecular Biology Objective)|Lapatinib may be able to control the growth of tumor cells. To assess the ability of lapatinib to block a molecule, the ERBB2 receptor, that signals tumor cells to divide, fresh frozen tissue from the surgical resection is processed by quantitative western blot analysis to assess the phosphorylation of ERBB2. The relative phosphorylation is a ratio of the phosphorylated ERBB2 measured in the tumor normalized to the level of total receptor protein and housekeeping protein. Lower values suggests more inhibition of the ERRB2 receptor signal and a decreased ability for tumor cell division.|7-14 days after starting therapy and prior to surgery|Participants enrolled on the molecular biology phase (MBP) and who submitted fresh frozen tissue were included in the analysis for this objective. One patient enrolled on the MBP did not provide fresh frozen tissue and was excluded. The sample size required for this objective was not met.|||ratio||Full Range|Median
1293596|NCT00095875|Secondary|Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years|Progression free survival was defined as the time from date of randomisation to disease progression or death from any cause without progression whichever occurred first; otherwise, patients were censored at the date last known to be free of progression.|5 years||||percent of patients||95% Confidence Interval|Number
1293597|NCT00095875|Primary|Overall Survival|To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival|3-years||||percent of patients||95% Confidence Interval|Number
1293598|NCT00095836|Secondary|Overall Survival|The median overall survival time, measured from the time of enrollment until death.|5 years||||Months||Full Range|Median
1293601|NCT00095836|Primary|Objective Tumor Response Rate at 3, 6, and 12 Months|"Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year.~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|3 Months, 6 Months, 1 Year|Two patients lost to follow-up prior to assessment of tumor response|||participants|||Number
1293602|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 12|Seven patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
1293603|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 5|Seven patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
1293604|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 1|Nine patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
1293605|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 12|Three patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
1293606|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 5|Three patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
1293607|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 1|Four patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
1293608|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 12|Eleven patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
1293609|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 5|Seven patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
1293610|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 1|Seven patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
1293611|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 12|Three patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
1293612|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 5|Three patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
1293613|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 1|Four patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
1293614|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 12|Six patients had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
1293615|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 5|Six patients had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
1293655|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 12|Laboratory hematology monocytes|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
1293616|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 1|Five patients had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
1293617|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 12|Three patients had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
1293618|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 5|One patient had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
1293619|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 1|One patient had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
1293620|NCT00095784|Primary|Incidence of Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0|Percentage of patients experiencing any toxicity, any grade level. Additional details on adverse events are reported in Adverse Events section.|Up to 30 days of last dose of decitabine||||percentage of patients||95% Confidence Interval|Number
1293621|NCT00095784|Primary|Response Rate (Complete Response, Partial Response, or Hematologic Improvement.|"Complete response is normalization of counts and transfusion-independence.~Partial response is hemoglobin increase to normal levels, multilineage improvement including absolute neutrophil count (ANC) and/or platelets.~Hematologic improvement is red cell transfusion-independence or >50% increase in platelet levels."|Up to 36 weeks (6 cycles)|Two patients were non-evaluable for response.|||percentage of participants||90% Confidence Interval|Number
1293622|NCT00095628|Other Pre-specified|1 Year Overall Survival|Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.|12 months||||percentage of participants||95% Confidence Interval|Number
1293623|NCT00095628|Secondary|Median Time to Progression|Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.|Up to 18 months||||months||95% Confidence Interval|Median
1293624|NCT00095628|Secondary|Median Overall Survival of SB-715992|Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.|Up to 18 months||||months||95% Confidence Interval|Median
1293625|NCT00095628|Secondary|Number of Participants With Clinical and Objective Stable Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.|Up to 18 months||||participants|||Number
1293626|NCT00095628|Secondary|Duration of Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion|Up to 18 months|Data were not collected because 0 participants showed a response.||||||
1293627|NCT00095628|Primary|Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion|Up to 18 months|20 eligible patients were analyzed|||participants|||Number
1293628|NCT00095576|Primary|HIV-1 Viral Load in Infected Participants|Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.||||||
1293629|NCT00095576|Primary|Number of Participants With HIV-1 Infections|The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.||||||
1293630|NCT00095576|Primary|Number of Participants With Laboratory Adverse Experiences|"Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring > 5% in at least one treatment group) following administration of the first dose of study vaccine.~Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.~All laboratory AEs were collected up to 14 days after any vaccine dose."|Day 1 to Week 208||||Participants|||Number
1293631|NCT00095576|Primary|Number of Participants With Clinical Adverse Experiences|"Number of participants with non-serious AEs with an incidence cut-off of 5% (>5% in at least one treatment group) and number of participants with >1 SAE following administration of study vaccine.~AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210).~Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose."|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)||||Participants|||Number
1293632|NCT00095563|Secondary|Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading|Number of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading.|Up to 5 years||||participants|||Number
1293633|NCT00095563|Secondary|Overall Survival (OS)|Survival estimates will be computed using the Kaplan-Meier method.|From the date of study enrolment to death or last contact, assessed up to 5 years|20 participants with ACC, 19 participants with non-ACC.|||months||95% Confidence Interval|Median
1293634|NCT00095563|Secondary|Progression-free Survival (PFS) According to RECIST||From the date of study enrolment to disease progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years|36 assessable participants, 19 with ACC and 17 with non-ACC.|||months||95% Confidence Interval|Median
1293635|NCT00095563|Secondary|Rate of Stable Disease|Number of patients who had Stable disease for more than or equal to 6 months together in both Adenoid cystic carcinoma (ACC) and non-adenoid cyctic carcinoma (non-ACC)|6 months|36 assessable participants, 19 with ACC and 17 with non-ACC.|||participants|||Number
1293636|NCT00095563|Secondary|Duration of Objective Response||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|This assessment was not performed since no participants showed a response.||||||
1293637|NCT00095563|Primary|Objective Response Rates (Partial and Complete Responses)|Per Response - Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;|Up to 5 years|36 assessable participants.|||participants|||Number
1293638|NCT00095498|Secondary|Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3|"Participants with laboratory toxicity of grade 3 or 4, graded according to the Common Terminology Criteria for Adverse Events, version 3.0, on the following general guideline:~Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death related to AE."|Month 1, month 3, month 6, month 12|Patients who received at least 1 dose of investigational product.|||Participants|||Number
1293639|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 12|Laboratory hematology white blood cells|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
1293640|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 6|Laboratory hematology white blood cells|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
1293641|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 3|Laboratpry hematology white blood cells|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
1293642|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 1|Laboratory hematology white blood cells|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
1293643|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 12|Laboratory hematology red blood cells|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
1293644|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 6|Laboratory hematology red blood cells|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
1293645|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 3|Laboratory hematology red blood cells|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
1293646|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 1|Laboratory hematology red blood cells|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
1293647|NCT00095498|Secondary|Change From Baseline in Platelets at Month 12|Laboratory hematology platelets|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
1293648|NCT00095498|Secondary|Change From Baseline in Platelets at Month 6|Laboratory hematology platelets|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
1293649|NCT00095498|Secondary|Change From Baseline in Platelets at Month 3|Laboratory hematology platelets|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
1293650|NCT00095498|Secondary|Change From Baseline in Platelets at Month 1|Laboratory hematology platelets|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
1293651|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 12|Laboratory hematology total neutrophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
1293652|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 6|Laboratory hematology total neutrophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
1293667|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 12|Laboratory hematology hematocrit|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1293668|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 6|Laboratory hematology hematocrit|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1293669|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 3|Laboratory hematology hematocrit|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1293670|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 1|Laboratory hematology hematocrit|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1293671|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 12|Laboratory hematology eosinophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
1293672|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 6|Laboratory hematology eosinophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
1293673|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 3|Laboratory hematology eosinophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
1293674|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 1|Laboratory hematology eosinophils|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
1293675|NCT00095498|Secondary|Change From Baseline in Basophils at Month 12|Laboratory hematology basophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
1293676|NCT00095498|Secondary|Change From Baseline in Basophils at Month 6|Laboratory hematology basophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
1293677|NCT00095498|Secondary|Change From Baseline in Basophils at Month 3|Laboratory hematology basophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
1293678|NCT00095498|Secondary|Change From Baseline in Basophils at Month 1|Laboratory hematology basophils|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||*10^9/L||Standard Deviation|Mean
1293679|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 12|Laboratory chemistry alanine amino transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||U/L||Standard Deviation|Mean
1293680|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 6|Laboratory chemistry alanine amino transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||U/L||Standard Deviation|Mean
1293681|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 3|Laboratory Chemistry alanine amino transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||U/L||Standard Deviation|Mean
1293682|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 1|Laboratory chemistry alanine amino transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||U/L||Standard Deviation|Mean
1293683|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 12|Laboratory chemistry aspartate amino transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||U/L||Standard Deviation|Mean
1293684|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase|Laboratory chemistry aspartate amino transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||U/L||Standard Deviation|Mean
1293685|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 3|Laboratory chemistry aspartate amino transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||U/L||Standard Deviation|Mean
1293686|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 1|Laboratory chemistry aspartate amino transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||U/L||Standard Deviation|Mean
1293687|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 12|Laboratory chemistry total protein|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||g/L||Standard Deviation|Mean
1293688|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 6|Laboratory chemistry total protein|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||g/L||Standard Deviation|Mean
1293689|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 3|Laboratory chemistry total protein|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||g/L||Standard Deviation|Mean
1293690|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 1|Laboratory chemistry total protein|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||g/L||Standard Deviation|Mean
1293691|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 12|Change From Baseline in Phosphorus at Month 12|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293692|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 6|Laboratory chemistry phosphorus|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293693|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 3|Laboratory chemistry phosphorus|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293694|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 1|Laboratory chemistry phosphorus|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293695|NCT00095498|Secondary|Change From Baseline in Sodium at Month 12|Laboratory chemistry sodium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293696|NCT00095498|Secondary|Change From Baseline in Sodium at Month 6|Laboratory chemistry sodium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293697|NCT00095498|Secondary|Change From Baseline in Sodium at Month 3|Change From Baseline in Sodium at Month 3|Baseline, Month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293698|NCT00095498|Secondary|Change From Baseline in Sodium at Month 1|Laboratory chemistry sodium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293699|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 12|Laboratory chemistry magnesium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293700|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 6|Laboratory chemistry magnesium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293701|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 3|Laboratory chemistry magnesium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293702|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 1|Laboratory chemistry magnesium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293703|NCT00095498|Secondary|Change From Baseline in Potassium at Month 12|Laboratory chemistry potassium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293704|NCT00095498|Secondary|Change From Baseline in Potassium at Month 6|Laboratory chemistry potassium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293705|NCT00095498|Secondary|Change From Baseline in Potassium at Month 3|Laboratory chemistry potassium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293706|NCT00095498|Secondary|Change From Baseline in Potassium at Month 1|Laboratory chemistry potassium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293707|NCT00095498|Secondary|Change From Baseline in Glucose at Month 12|Laboratory chemistry glucose|baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293708|NCT00095498|Secondary|Change From Baseline in Glucose at Month 6|Laboratory chemistry glucose|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293709|NCT00095498|Secondary|Change From Baseline in Glucose at Month 3|Laboratory chemistry glucose|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293710|NCT00095498|Secondary|Change From Baseline in Glucose at Month 1|Laboratory chemistry glucose|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293711|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 12|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||U/L||Standard Deviation|Mean
1293712|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 6|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||U/L||Standard Deviation|Mean
1293713|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 3|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||U/L||Standard Deviation|Mean
1293714|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 1|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||U/L||Standard Deviation|Mean
1293715|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 12|Laboratory chemistry creatinine|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||µmol/L||Standard Deviation|Mean
1293716|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 6|Laboratory chemistry creatinine|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||µmol/L||Standard Deviation|Mean
1293717|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 3|Laboratory chemistry creatinine|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||µmol/L||Standard Deviation|Mean
1293718|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 1|Laboratory chemistry creatinine|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||µmol/L||Standard Deviation|Mean
1293719|NCT00095498|Secondary|Change From Baseline in Chloride at Month 12|Laboratory chemistry chloride|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293720|NCT00095498|Secondary|Change From Baseline in Chloride at Month 6|Laboratory chemistry chloride|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293721|NCT00095498|Secondary|Change From Baseline in Chloride at Month 3|Laboratory chemistry chloride|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293722|NCT00095498|Secondary|Change From Baseline in Chloride at Month 1|Laboratory chemistry chloride|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293723|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 12|Laboratory chemistry albumin-adjusted calcium|Baselien, Month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293724|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 6|Laboratory chemistry albumin-adjusted calcium|Baseline, Month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293725|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 3|Laboratory chemistry albumin-adjusted calcium|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293726|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 1|Laboratory chemistry albumin-adjusted calcium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293727|NCT00095498|Secondary|Change From Baseline in Calcium at Month 12|Laboratory chemistry calcium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293728|NCT00095498|Secondary|Change From Baseline in Calcium at Month 6|Laboratory chemistry calcium|baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293729|NCT00095498|Secondary|Change From Baseline in Calcium at Month 3|Laboratory chemistry calcium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293730|NCT00095498|Secondary|Change From Baseline in Calcium at Month 1|Laboratory chemistry calcium|baseline. month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293731|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 12|Laboratory chemistry blood urea nitrogen|baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293732|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 6|Laboratory chemistry blood urea nitrogen|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293733|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 3|Laboratory chemistry blood urea nitrogen|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293734|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 1|Laboratory chemistry blood urea nitrogen|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293735|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 12|Laboratory chemistry total bilirubin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||umol/L||Standard Deviation|Mean
1293736|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 6|Laboratory chemistry total bilirubin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||umol/L||Standard Deviation|Mean
1293737|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 3|Laboratory chemistry total bilirubin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||umol/L||Standard Deviation|Mean
1293738|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 1|Laboratory chemistry total bilirubin|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||umol/L||Standard Deviation|Mean
1293739|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 12|Laboratory chemistry bicarbonate|Baseline, Month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
1293740|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 6|Laboratory chemistry bicarbonate|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
1293741|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 3|Laboratory chemistry bicarbonate|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
1293742|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 1|Laboratory chemistry bicarbonate|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
1293743|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 12|Laboratory chemistry alkaline phosphatase|baseine, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||U/L||Standard Deviation|Mean
1293744|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 6|Laboratory chemistry alkaline phosphatase|baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||U/L||Standard Deviation|Mean
1293745|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 3|Laboratory chemisrty alkaline phosphatase|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||U/L||Standard Deviation|Mean
1293746|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 1|Laboratory chemistry alkaline phoshatatse|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||U/L||Standard Deviation|Mean
1293747|NCT00095498|Secondary|Change From Baseline in Albumin at Month 12|Laboratory chemistry albumin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||g/L||Standard Deviation|Mean
1293748|NCT00095498|Secondary|Change From Baseline in Albumin at Month 6|Laboratory chemistry albumin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||g/L||Standard Deviation|Mean
1293749|NCT00095498|Secondary|Change From Baseline in Albumin at Month 3|Laboratory chemistry albumin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||g/L||Standard Deviation|Mean
1293750|NCT00095498|Secondary|Change From Baseline in Albumin at Month 1|Laboratory Chemistry Albumin|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||g/L||Standard Deviation|Mean
1293751|NCT00095498|Secondary|Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody|Serum from participants testing positive for anti-denosumab binding antibodies was tested in a cell-based bioassay for neutralizing activity against denosumab.|Baseline to Month 12|Patients who were positive for anti-denosumab antibodies|||Participants|||Number
1293752|NCT00095498|Secondary|Number of Participants With Anti-Denosumab Binding Antibodies|Serum from participants was tested for antibodies to denosumab by immuoassay at months 1, 3, 6 and 12. The number of participants with anti-denosumab antibodies at any assessment is reported.|Assessed at Baseline and at Months 1, 3, 6 and 12.|Patients who received at least 1 dose of investigational product and with at least one postbaseline sample taken.|||Participants|||Number
1293753|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12|Percent change from baseline to Month 12 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293754|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6|Percent change from baseline to Month 6 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293755|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3|Percent change from baseline to Month 3 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293756|NCT00095498|Secondary|Percent Change From Baseline in P1NP at Month 12|Percent change from baseline to Month 12 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293757|NCT00095498|Secondary|Percent Change From Baseline in P1NP at Month 6|Percent change from baseline to Month 6 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293758|NCT00095498|Secondary|Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3|Percent change from baseline to Month 3 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293759|NCT00095498|Secondary|Percent Change From Baseline in Serum CTX at Month 12|Percent change from Baseline to Month 12 in serum C-Telopeptide (CTX) Type I calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293760|NCT00095498|Secondary|Percent Change From Baseline in Serum CTX at Month 6|Percent change from baseline to Month 6 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293761|NCT00095498|Secondary|Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3|Percent change from baseline to Month 3 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.|||Percent change from baseline||Inter-Quartile Range|Median
1293762|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Standard Error|Least Squares Mean
1293763|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Standard Error|Least Squares Mean
1293764|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.|||Percent change from baseline||Standard Error|Least Squares Mean
1293765|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Standard Error|Least Squares Mean
1293766|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Standard Error|Least Squares Mean
1293767|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1|"Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100.~Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic)."|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.|||Percent change from baseline||Standard Error|Least Squares Mean
1293768|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Standard Error|Least Squares Mean
1293769|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to month 6 calculated using ((month 6 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Standard Error|Least Squares Mean
1293770|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((month 1 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.|||Percent change from baseline||Standard Error|Least Squares Mean
1293771|NCT00095498|Secondary|Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6|Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||units on a scale||Inter-Quartile Range|Median
1293772|NCT00095498|Secondary|Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12|Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||units on a scale||Inter-Quartile Range|Median
1293773|NCT00095498|Secondary|Change From Baseline in Radiographic Erosion Score at Month 6|The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||units on a scale||Inter-Quartile Range|Median
1293774|NCT00095498|Secondary|Change From Baseline in Radiographic Erosion Score at Month 12|The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||units on a scale||Inter-Quartile Range|Median
1293775|NCT00095498|Secondary|Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6|TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||units on a scale||Inter-Quartile Range|Median
1293776|NCT00095498|Secondary|Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12|TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||units on a scale||Inter-Quartile Range|Median
1293777|NCT00095498|Primary|Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6|Fifteen sites in each wrist and 10 sites in each hand were assessed by a blinded and independent reader. Each site was scored from 0 to 10 (in accordance with the European League Against Rheumatism [EULAR]-Outcome Measures in Rheumatology Clinical Trials convention), with each unit increment representing 10% incremental loss of the peripheral 1 cm of articular bone. The Erosion Score is a sum of erosion scores from 50 joint sites in both hands/wrists and ranges from 0 (normal, no erosion) to 500 (worst possible erosion).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||units on a scale||Full Range|Median
1293778|NCT00095303|Secondary|Follow Up Study, Risky Sexual Behaviors|For the Follow Up Study, sexual risk behavior was measured by examining the number of unprotected sexual acts and the number of partners and number of sex acts that included substance use the in the 90 day period that preceded the assessment; a latent factor using structural equation modeling will be used created from the Behavioral Risk Assessment. Scores ranged from -0.5 to 11.7. The higher the score, the more risky sexual behavior.|90 days prior assessment||||units on a scale||Standard Error|Least Squares Mean
1293779|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 12 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 6.7. The higher the score, the more risky sexual behavior.|12 months post randomization||||units on a scale||Standard Error|Least Squares Mean
1293780|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 8 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 6.8. The higher the score, the more risky sexual behavior.|8 months post randomization||||units on a scale||Standard Error|Least Squares Mean
1293781|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 4 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 10.4. The higher the score, the more risky sexual behavior.|4 months post randomization||||units on a scale||Standard Error|Least Squares Mean
1293782|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at Baseline|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 8.7. The higher the score, the more risky sexual behavior.|Baseline||||units on a scale||Standard Error|Least Squares Mean
1293783|NCT00095303|Secondary|Follow Up Study, Level of Family Functioning|For the follow up study, family functioning was measured by a composite of the Cohesion and Conflict scales of the Family Environment Scale. Scores ranged from 1.0 to 18.0. The higher the value, the better the level of family functioning outcome.|90 days prior assessment||||units on a scale||Standard Deviation|Mean
1293784|NCT00095303|Secondary|Main Study, Level of Family Functioning at 12 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.6 to 2.0. The higher the score, the better outcome of family functioning.|12 months post randomization||||units on a scale||Standard Deviation|Mean
1293785|NCT00095303|Secondary|Main Study, Level of Family Functioning at 8 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.8 to 2.0. The higher the score, the better outcome of family functioning.|8 months post randomization||||units on a scale||Standard Deviation|Mean
1293786|NCT00095303|Secondary|Main Study, Level of Family Functioning at 4 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -2.9 to 1.8. The higher the score, the better outcome of family functioning.|4 months post randomization||||units on a scale||Standard Deviation|Mean
1293787|NCT00095303|Secondary|Main Study, Level of Family Functioning at Baseline|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -3.0 to 1.8. The higher the score, the better outcome of family functioning.|Baseline||||units on a scale||Standard Error|Mean
1293788|NCT00095303|Secondary|Follow Up Study, Externalizing Behavior|For the follow up study, externalizing behavior for the 90 days prior to the follow up was assessed using the externalizing composite of the Adult Self Report (ASR). The ASR is a 123 item self report scale designed for 18 to 59 year-old to describe their own functioning. Items are on a 3 point likert type scale (0= not true, 1=somewhat true, 2=very true or often true). The externalizing scale is comprised by the aggressive, rule braking and intrusive syndromes. The problem syndromes have been normed by sex and age (18 to 35, or 36 to 59), using a nationally representative sample. Scores were square-root transformed to more closely approximate a normal distribution. Scores ranged from 0 to 7.2. The higher the score, the more externalizing behavior. Participants were also asked to self report arrests in the past year . Externalizing was analyzed using regression|90 days prior to assessment||||units on a scale||Standard Deviation|Mean
1293789|NCT00095303|Primary|Follow Up Study, Drug Use|Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.|Number of self reported drug use days 90 days prior to assessment||||days of drug use 90 days prior assessmen||Inter-Quartile Range|Median
1293790|NCT00095303|Primary|Follow Up Study, Drug Use|Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.|Number of self reported drug use days 90 days prior assessment||||days of drug use 90 days prior assessmen||Inter-Quartile Range|Median
1293791|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 337-364|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 337-364. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 337-364||Inter-Quartile Range|Median
1293792|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 309-336|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 309-336. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 309-336||Inter-Quartile Range|Median
1293793|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use from days 281-308|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 281-308. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 281-308||Inter-Quartile Range|Median
1293794|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 253-280|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 253-280. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 253-280||Inter-Quartile Range|Median
1293795|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 225-252|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 225-252. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 225-252||Inter-Quartile Range|Median
1293816|NCT00095238|Secondary|Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants|||Participants|||Number
1293796|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 197-224|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 197-224. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 197-224||Inter-Quartile Range|Median
1293797|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 169-196|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 169-196. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 169-196||Inter-Quartile Range|Median
1293798|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 141 - 168|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 141-168. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 141-168||Inter-Quartile Range|Median
1293799|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 113-140|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 113-140. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from days 113-140||Inter-Quartile Range|Median
1293800|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 85-112|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 85-112. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 85-112||Inter-Quartile Range|Median
1293817|NCT00095238|Secondary|Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants|||Participants|||Number
1293801|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 57-84|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 57-84. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 57-84||Inter-Quartile Range|Median
1293802|NCT00095303|Secondary|Main Study, Externalizing Behavior at 12 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.4. The higher the score, the more externalizing behavior.|12 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 12 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||units on a scale||Standard Deviation|Mean
1293803|NCT00095303|Secondary|Main Study, Externalizing Behavior at 8 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.5. The higher the score, the more externalizing behavior.|8 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 8 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||units on a scale||Standard Deviation|Mean
1293804|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days in days 29-56|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 29-56. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use in days 29-56||Inter-Quartile Range|Median
1293805|NCT00095303|Secondary|Main Study, Externalizing Behavior at 4 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.8. The higher the score, the more externalizing behavior.|4 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 4 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||units on a scale||Standard Deviation|Mean
1293806|NCT00095303|Secondary|Main Study, Externalizing Behaviors at Baseline|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.0. The higher the score, the more externalizing behavior.|Baseline|The number of participants analyzed represents the number of participants that completed this time point, assessing externalizing behaviors at baseline. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||units on a scale||Standard Deviation|Mean
1295403|NCT00082407|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, after breakfast, pre-lunch, after lunch, pre-dinner, after dinner, 0300 hours) SMBG profile from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat|||mmol/L||Standard Deviation|Mean
1293807|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 1-28|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 1-28. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 1-28||Inter-Quartile Range|Median
1293808|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from 28 days prior to baseline|The number of participants analyzed represents the number of participants that completed the baseline time point, assessing for the past 28 days. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use 28 days prior baseline||Inter-Quartile Range|Median
1293809|NCT00095238|Secondary|Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)|Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.|Baseline, Final Visit|Randomized subjects (total=4128) with no prior AF history or evidence of AF on baseline ECG, stratified by use of ACE-I|||participants|||Number
1293810|NCT00095238|Secondary|Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66|Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.|Baseline, Month 42, Month 54, Month 66|Participants with baseline score and score at timepoint.|||mL/min/1.73m2||Standard Error|Mean
1293811|NCT00095238|Secondary|Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30|Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.|Baseline, Month 6, Month 18, Month 30|Participants with baseline score and score at timepoint.|||mL/min/1.73m2||Standard Error|Mean
1293812|NCT00095238|Secondary|Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints|Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized participants with no prior diabetes history|||percentage of participants|||Number
1293813|NCT00095238|Secondary|Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints|Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.|Year 1, Year 2, Year 3, Year 4, Year 5||||percentage of participants|||Number
1293814|NCT00095238|Secondary|Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints|Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.|Year 1, Year 2, Year 3, Year 4, Year 5|randomized participants|||percentage of participants|||Number
1293815|NCT00095238|Secondary|Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants|||Participants|||Number
1293818|NCT00095238|Secondary|Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline|This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.||||participants|||Number
1293819|NCT00095238|Secondary|Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit|NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.|Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized participants with measurement at baseline and Month 6, Month 10, Month 14, and Final Visit|||participants|||Number
1293820|NCT00095238|Secondary|Percentage of Participants Experiencing All-cause Death at Given Time Points|Treatment comparisons for time to all-cause death|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized subjects|||percentage of participants|||Number
1293821|NCT00095238|Secondary|Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints|Treatment comparisons for time to cardiovascular death|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Subjects|||percentage of participants|||Number
1293822|NCT00095238|Secondary|Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints|Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants|||percentage of participants|||Number
1293823|NCT00095238|Secondary|Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14|Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.|Baseline, Month 6, Month 14|number of participants with measurement at baseline and at timepoint|||pg/mL||Standard Error|Geometric Mean
1293824|NCT00095238|Secondary|Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit|Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.|Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Participants with baseline score and score at timepoint.|||units on a scale||Standard Error|Mean
1293825|NCT00095238|Secondary|Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14|Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.|Baseline, Month 6, Month 14|Participants with baseline score and score at timepoint.|||units on a scale||Standard Error|Mean
1293826|NCT00095238|Secondary|Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points|Treatment comparisons for time to heart failure mortality or heart failure hospitalization|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants|||percentage of participants|||Number
1293827|NCT00095238|Primary|Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints|Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants|||percentage of participants|||Number
1293828|NCT00095212|Secondary|Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.|Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds.|Baseline (time 0) to 18 months|data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing.|||kilograms||Standard Error|Mean
1293829|NCT00095212|Secondary|Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.|Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds.|Baseline (time 0) to 18 months|data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing.|||kilograms||Standard Error|Mean
1293864|NCT00095147|Primary|OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period|Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), units=mm mercury (Hg)|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.|||mm mercury (Hg)||Standard Deviation|Mean
1293830|NCT00095212|Secondary|"Neurocognitive Function: Hopkins Verbal Learning Test-revised,Total Recall Z Score Represents Change in Z Score From Baseline to 18 Months."|This test assesses verbal learning and memory. Subjects are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate trials. The Total Recall Z score is calculated based on the sum of total correct responses for Trials 1,2,& 3. A Z score of 0 equals the 50 percentile, a Z score of 1 is 1 standard deviation above the mean and a Z score of -1 is 1 standard deviation below the mean. The lowest and highest T scores for the HVLT-R are ≤20 and ≥80. This correlates to lowest and highest Z scores of ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor recall.|Baseline (time 0) to 18 months|data not available for all subjects as some did not wish to complete the testing|||Units on a scale||Standard Error|Mean
1293831|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months||||participants|||Number
1293832|NCT00095212|Secondary|Safety: Number of Subjects Reporting Acne|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months||||participants|||Number
1293833|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months||||participants|||Number
1293834|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Skin Reaction to the Patch|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months||||participants|||Number
1293835|NCT00095212|Secondary|Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function|Represents change in measure from baseline to 18 months. The BISF is 22 items with seven domains: Thoughts and Desires, Arousal, Frequency of Sexual Activity, Receptivity/Initiation, Pleasure, Relationship Satisfaction, and Problems Affecting Sexual Function. Data from Domain 7: Problems Affecting Sexual Function is reported. The score range for this domain is -16 to 75,a higher score indicates greater sexual function.|Baseline (time 0) to 18 months|data not available for all subjects as some did not wish to complete the questionnaire|||Units on a scale||Standard Error|Mean
1293836|NCT00095212|Secondary|Quality of Life/Depression: Becks Depression Inventory|Represents change in the mean score from baseline to 18 months. Depression was evaluated with the Beck’s Depression Inventory (BDI). The BDI is a 21-item self-report instrument used to assess the presence and severity of symptoms of depression. A Total score in the range of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (time 0) to 18 months||||Units on a scale||Standard Error|Mean
1293837|NCT00095212|Secondary|Bone Mineral Density of the Hip|Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for bone mineral density of the hip measured by dual energy absorptiometry (DEXA)scan.|Baseline (time 0) to 18 months||||grams per centimeter squared||Standard Error|Mean
1293838|NCT00095212|Primary|Lean Body Mass|Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan.|Baseline (time 0) to 18 months|Responses at 9 and 18 months were pooled as the post treatment repeated measures. All data were included in the analysis, including 9 month data from the 4 subjects who discontinued after the 9 month visit.|||kilograms||Standard Error|Mean
1293839|NCT00095199|Secondary|Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities|National Cancer Institutes-Common Toxicity Criteria version 3.0 was used by investigators to assess participant toxicities. Mapping of investigator verbatim terms to CTCAE terms was done by the sponsor/designee using CTCAE v4.0. Participants reported had grade 3 or 4 toxicities (or both potentially). Grade 3 AEs: severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 AEs: life-threatening consequences; urgent intervention indicated.|Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone)|All randomized participants receiving at least 1 dose of study drug made up the safety population for this outcome measure. Investigators graded events using CTCAE v3.0. Mapping of investigator verbatim terms for toxicity to CTCAE terms was done by the sponsor/designee using CTCAE v4.0.|||participants|||Number
1295404|NCT00082407|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline to week 52|baseline, week 52|Intent to Treat, computed from the patients having both baseline and week 52 data.|||mmol/L||Standard Error|Least Squares Mean
1293840|NCT00095199|Secondary|Duration of Overall Response (OR)|The duration of response, in participants with best OR of complete response (CR) or partial response (PR), was measured from the date criteria are met for CR/PR (not confirmation date, whichever was first recorded), until the first occurrence date that the criteria of progressive disease (PD) was met, or death. Participants who were alive and without progression were censored at the date of their last independent review committee (IRC) tumor assessment. The tumor response and progression were assessed by the IRC in the Pemetrexed group and by the investigator in the Docetaxel group.|Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months|All randomized participants with a best overall response of CR or PR. Censored participants: 1 in Cetuximab plus Pemetrexed arm; 2 in Pemetrexed arm; 1 in Cetuximab plus Docetaxel arm; 0 in Docetaxel arm.|||months||95% Confidence Interval|Median
1293841|NCT00095199|Secondary|Time to Symptomatic Progression|The FACT-LCS (see description in Outcome measure 5) inventories problems specific to lung cancer symptoms. Using this Scale, Symptom progression = a ≥ 2 point decrease from baseline in LCS score maintained for 2 consecutive assessments ≥3 weeks, and <5 weeks, apart. The symptom progression date = the first of 2 consecutive assessments with a ≥2 point decline. Time to symptomatic progression = the time from randomization to the symptom progression date. For participants with no symptom progression, time to symptomatic progression was censored the date of last symptom assessment.|Randomization until symptomatic progression up to 48.3 months|All randomized participants with a baseline LCS >= 2 were included. Censored participants: 237 in Cetuximab plus Pemetrexed arm; 244 in Pemetrexed arm; 126 in Cetuximab plus Docetaxel arm; 131 in Docetaxel arm.|||months||95% Confidence Interval|Median
1293842|NCT00095199|Secondary|Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L)|The FACT-LCS is a set of 7 questions to inventory problems specific to lung cancer symptoms. Participants rate each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). Scores range from 0-28 and higher score indicates fewer symptoms. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item LCS score that was maintained for 2 consecutive assessments at least 3 weeks, and not >5 weeks apart for participants, whose baseline LCS score was ≤26. Symptom response rate was the percentage of participants with symptomatic response.|At baseline, every 3 weeks and 30 days after end of therapy up to 50 months|The randomized participants with baseline LCS scores less than or equal to 26.|||percentage of participants||95% Confidence Interval|Number
1293843|NCT00095199|Secondary|Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD)|The disease control rate (DCR) was the proportion of randomized participants with a best OR of CR, PR or SD according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR, PR or SD divided by the total number of participants randomized in that arm. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.|Randomization to progression of disease or death due to any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
1293844|NCT00095199|Secondary|Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])|The best overall response rate (ORR) was the proportion of randomized participants with a best OR of CR or PR, according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR or PR divided by the total number of participants treated in that arm. Participants with no post-baseline evaluation were considered as non-responders. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.|Randomization until progression of disease or death from any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
1293845|NCT00095199|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death. Participants without a date of death were censored on the last date participants were known to be alive, or lost to follow-up.|Randomization to the date of death from any cause up to 72.8 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 24 in Cetuximab + Pemetrexed arm; 43 in Pemetrexed arm; 12 in Cetuximab + Docetaxel arm; 22 in Docetaxel arm.|||months||95% Confidence Interval|Median
1293846|NCT00095199|Primary|Progression Free Survival (PFS)|PFS was defined as the time from randomization until the date of progressive disease (PD) or death from any cause. Participants who were alive and without progression were censored at the date of their last tumor assessment. PFS was assessed by the independent review committee (IRC) in the Pemetrexed group (Cetuximab & Pemetrexed versus Pemetrexed) and by the investigator in the Docetaxel group (Cetuximab & Docetaxel versus Docetaxel).|Randomization to progression of disease or death due to any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 10 in Cetuximab + Pemetrexed arm; 25 in Pemetrexed arm; 6 in Cetuximab + Docetaxel arm; 16 in Docetaxel arm.|||months||95% Confidence Interval|Median
1293847|NCT00095173|Secondary|Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)|During Period C, blood samples for immunogenicity assessments were obtained just prior to the start of the IV infusion of abatacept at 3-month intervals during the first 2 years of Period C, at 6-month intervals thereafter, and again 28, 56, and 85 days after the last infusion. Direct-format, enzyme-linked immunosorbent assays (ELISAs) were used to evaluate the cytotoxic T-lymphocyte antigen 4 (CTLA4) and the anti-CTLA4-T antibody.|Period C (Day 282 to 85 days after the last dose of study medication)|All treated participants who were evaluated for immunogenicity during Period C|||participants|||Number
1294158|NCT00094328|Primary|Change in Growth Rate (SD Units)|Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score).|Assessed after 12 months treatment|All treated (AT) set|||SD units||Standard Deviation|Mean
1293848|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)|Marked abnormalities were pre-defined as changes in lab tests after drug infusion and relative to normal range. Hemoglobin,11.6-14.8grams per deciliter(g/dL);Hematocrit,36.0-50.0 percent;Erythrocytes,3.80-5.10x10*6 cells per microliter(c/uL);Platelets,140-44 cells per liter(c/L);Leukocytes,4.00-12.50c/uL;Absolute(Abs)Neutrophils+Bands,<1.00x10^3 c/uL;Abs Lymphocytes,<0.72x10^3 or>7.50x10^3 c/uL;Abs Eosinophils,>0.750X10^3 c/uL;Alkaline Phosphatase,0-40 units per liter(U/L);Aspartate Aminotransferase,0-40 U/L;Alanine Aminotransferase,0-40U/L;G-Glutamyl Transferase,0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter(mg/dL);Blood Urea Nitrogen,5.9-26.0 mg/dL;Creatinine, 0.50-1.50mg/dL;Inorganic Phosphorus,2.8-6.2 U/L;Serum Potassium,3.5-5.5 milliequivalents per liter(mEq/L);Serum Glucose,65-99 mg/dL;Fasting Serum Glucose,65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin,3.5-5.5 g/dL;Urine Protein,>=4;Urine Glucose,>=4;Urine Blood,>=4;Urine Red Blood Cells>=4;Urine White Blood Cells,>=4.|Period C (Day 282 to end of study)|All treated participants in Period C evaluated for a specific analyte.|||participants|||Number
1293849|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)|Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Aspartate Aminotransferase, 0-40 units per liter (U/L); Alanine Aminotransferase, 0-40 U/L;Blood Urea Nitrogen, 5.9-26.0 mg/dL;Serum Sodium, 135-148 milliequivalents per liter (mEq/L);Serum Potassium, 3.5-5.5 mEq/L;Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Urine Protein, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.|Period B (Day 113 to Day 282)|All treated participants in Period B evaluated for a specific analyte.|||participants|||Number
1293850|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)|Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Alanine Aminotransferase, 0-40 units per liter (U/L);G-Glutamyl Transferase, 0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter (mg/dL);Blood Urea Nitrogen, 5.9-26.0 mg/dL;Creatinine, 0.50-1.50 mg/dL;Serum Potassium, 3.5-5.5 milliequivalents per liter (mEq/L);Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin, 3.5-5.5 g/dL;Urine Protein, >=4;Urine Glucose, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.|Period A (Day 1 to Day 113)|All treated participants in Period C evaluated for a specific analyte.|||participants|||Number
1293851|NCT00095173|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate|The ACRP30 response criteria were defined as a ≥ 30% improvement over baseline in ESR. ACRP 50, 70, and 90 responses were defined similarly with 50%, 70%, and 90% improvements required, respectively.|Day 113, Day 282, and Day 2047|All treated participants|||percentage of participants||95% Confidence Interval|Number
1293852|NCT00095173|Secondary|Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period C (Day 282 up to 56 days after the last dose of study medication)|All treated participants in Period C|||participants|||Number
1293853|NCT00095173|Secondary|Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period B (Day 113 to Day 282)|All treated participants in Period B|||participants|||Number
1293854|NCT00095173|Secondary|Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period A (Day 1 to Day 113)|All treated participants in Period A|||participants|||Number
1293865|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||U/L||Standard Error|Mean
1293855|NCT00095173|Secondary|Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)|Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.|Period C (Day 282 to end of study)|All treated participants in Period C|||percentage change from baseline||Inter-Quartile Range|Median
1293856|NCT00095173|Secondary|Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)|Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.|Period B (Day 113 to Day 282)|All treated participants in Period B|||percentage change from baseline||Inter-Quartile Range|Median
1293857|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).|Period C (Day 282 to end of study)|All treated participants in Period C|||participants|||Number
1293858|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1)."|Period B (Day 113 to Day 282)|All treated participants in Periods B|||participants|||Number
1293859|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1)."|Period A (Day 1 to Day 113)|All treated participants in Periods A|||participants|||Number
1293860|NCT00095173|Secondary|Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)|"All of the following criteria must be met to be defined as a flare:~> 30% worsening in at least 3 of the 6 JRA/JIA core response variables~> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables~≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare~worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)"|Period B (Day 113 to Day 282)|All treated participants|||participants|||Number
1293861|NCT00095173|Primary|Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)|"Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed.~All of the following criteria must be met to be defined as a flare:~> 30% worsening in at least 3 of the 6 JRA/JIA core response variables~> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables~≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare~worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)"|Period B (Day 113 to Day 282)|All treated participants|||months||Full Range|Median
1293862|NCT00095147|Primary|OL; Mean Temperature (T) During Open Label Period|Temperature (T), units=degrees Celcius|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.|||degrees Celsius||Standard Deviation|Mean
1293863|NCT00095147|Primary|OL; Mean Heart Rate (HR) During Open Label Period|Heart Rate (HR), units=beats per minute (bpm)|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.|||beats per minute (bpm)||Standard Deviation|Mean
1293866|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mg/dL||Standard Error|Mean
1293867|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mEq/L||Standard Error|Mean
1293868|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^6 c/uL||Standard Error|Mean
1293869|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^3 c/uL||Standard Error|Mean
1293870|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage of red blood cells||Standard Error|Mean
1293871|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^9 c/L||Standard Error|Mean
1293872|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||g/dL||Standard Error|Mean
1293873|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||U/L||Standard Error|Mean
1293874|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mg/dL||Standard Error|Mean
1293875|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mEq/L||Standard Error|Mean
1293876|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^6 c/uL||Standard Error|Mean
1293877|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^3 c/uL||Standard Error|Mean
1293878|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage of red blood cells||Standard Error|Mean
1293879|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^9 c/L||Standard Error|Mean
1293880|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||g/dL||Standard Error|Mean
1293881|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||U/L||Standard Error|Mean
1293882|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mg/dL||Standard Error|Mean
1293883|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mEq/L||Standard Error|Mean
1293884|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^6 c/uL||Standard Error|Mean
1293885|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^3 c/uL||Standard Error|Mean
1293886|NCT00095147|Secondary|OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Day 1 (Baseline), Day 729|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.|||units on a scale||Standard Error|Mean
1293887|NCT00095147|Secondary|OL; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Over Time|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|OL Days 197, 253, 281, 309, 337, 365, 449, 533, 617, and 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.|||percentage of participants|||Number
1293888|NCT00095147|Secondary|OL; Percentage of Participants Who Achieved Major Clinical Response|Major Clinical Response was defined as a continuous ACR 70 for six months.|Defined from the date of achieving ACR 70 response to 6 months post response|Protocol-specified analyses of the proportion of participants achieving a Major Clinical Response were not performed since ACR responses in the open-label period could only be assessed at 6-month intervals due to the fact that CRP and ESR were only measured every 6 months during this period.||||||
1293899|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^6 c/uL||Standard Error|Mean
1294159|NCT00094328|Primary|Change in Growth Rate (cm/Year)|Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).|Assessed after 12 months treatment|All treated (AT) set|||cm/year||Standard Deviation|Mean
1293889|NCT00095147|Secondary|OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 197, Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage of participants|||Number
1293890|NCT00095147|Secondary|OL; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Over Time|The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute >5.1 or <0.6 change from BL)|DB Days 365, 533, and 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.|||percentage of participants|||Number
1293891|NCT00095147|Secondary|OL; Percentage of Participants With DAS28 (ESR) Remission and Low Disease Activity (LDAS) Over Time|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Efficacy data was summarized for the 3 DB treatment cohorts.n=number of participants with data available.|||percentage of participants|||Number
1293892|NCT00095147|Secondary|OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.|||units on a scale||Standard Error|Mean
1293893|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage of red blood cells||Standard Error|Mean
1293894|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^9 c/L||Standard Error|Mean
1293895|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||g/dL||Standard Error|Mean
1293896|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||U/L||Standard Error|Mean
1293897|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mg/dL||Standard Error|Mean
1293898|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mEq/L||Standard Error|Mean
1293900|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^3 c/uL||Standard Error|Mean
1293901|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage red blood cells||Standard Error|Mean
1293902|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^9 c/L||Standard Error|Mean
1293903|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||g/dL||Standard Error|Mean
1293904|NCT00095147|Secondary|DB; Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA]) From Day 1 Through Day 365|Infliximab levels were measured using a microplate enzyme-linked immunosorbant assay (ELISA) with infliximab bound to immobilized recombinant tumor necrosis factor (TNF)-alpha. Bound infliximab is detected utilizing a horseradish peroxidase-conjugated anti-human IgG Fc(fragment, crystallizable region)-specific). The enzyme turns over the substrate O-phenlenediamine to a chromogenic product that is measured at 490 nm. The cut-off value was 1.40 ug/mL; this was based on the mean (+ 3 SD) value in serum samples from 40 participants who had never received infliximab.|Day 1 through day 365|The immunogenicity analysis population included participants who received at least one dose of infliximab and had immunogenicity samples collected at baseline and at least one post-baseline treatment visit.|||percentage of participants|||Number
1293905|NCT00095147|Secondary|DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay)|ECL screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|Day 1 through day 365|The immunogenicity analysis population included participants who received at least one dose of abatacept and had immunogenicity samples collected at baseline and at least one post-baseline treatment visit.|||participants|||Number
1293906|NCT00095147|Secondary|DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 365|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
1293907|NCT00095147|Secondary|DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 197|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
1293908|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Temperature During Days 1 Through 197 and Days 1 Through 365|Temperature (T) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|As Treated Population.|||participants|||Number
1293909|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Heart Rate During Days 1 Through 197 and Days 1 Through 365|Heart Rate (HR) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study|As Treated Population.|||participants|||Number
1293910|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Systolic and Diastolic Blood Pressure During Days 1 Through 197 and Days 1 Through 365|Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study|As-Treated Population|||participants|||Number
1293911|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
1293912|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 365|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
1293913|NCT00095147|Primary|OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL|From Day 366 through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.|||participants|||Number
1293914|NCT00095147|Primary|OL; Number of Participants With Select Hematologic Laboratory Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; monocytes: >2000 mm3; eosinophils: >0.750 x 10^3 c/uL;|From Day 366 through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.|||participants|||Number
1293915|NCT00095147|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.|||participants|||Number
1293916|NCT00095147|Primary|OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.|||participants|||Number
1293917|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
1293918|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 365|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
1293919|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 197|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
1293920|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 197|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
1293921|NCT00095147|Secondary|DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
1293922|NCT00095147|Secondary|DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 197|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
1293923|NCT00095147|Secondary|DB; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) at Day 365|The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL)|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
1293924|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 365 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), 12 months (Day 365)|ITT Population: all participants randomized into the study receiving study medication, grouped according to randomization treatment. Although 3 participants in PLA group discontinued before Day 197, 2 of these patients were included in the LOCF analysis. SF-36 component scores were not presented in tabular form.|||units on a scale||Standard Error|Mean
1293925|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), 6 months (Day 197)|ITT population, all participants randomized into the study receiving study medication. Participants grouped according to the treatment to which they were randomized. All randomized participants who never received study medication were excluded. SF-36 component scores were not presented in tabular form.|||units on a scale||Standard Error|Mean
1293926|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Baseline (Day 1), 12 months (Day 365)|Intent-to-Treat (ITT) Population: all participants randomized into the study receiving study medication, grouped according to randomization treatment. All participants randomized but never receiving study medication excluded. Although 3 participants in PLA group discontinued before Day 197, 2 of these patients were included in the LOCF analysis.|||units on a scale||Standard Error|Mean
1293927|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||units on a scale||Standard Error|Mean
1293928|NCT00095147|Secondary|DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
1293929|NCT00095147|Secondary|DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|DB Day 197|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
1293930|NCT00095147|Secondary|DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Clinically significant response= decrease in DAS28 score of >1.2 from baseline. DAS28 AUC can be calculated from the DAS28 score versus time curve, which provides an assessment of changes in disease activity over time.|From Day 1 through Day 365 (12 months)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||units on a scale||Standard Deviation|Mean
1293931|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||units on a scale||Standard Error|Mean
1293932|NCT00095147|Primary|DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or C-reactive protein (CRP), and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||units on a scale||Standard Error|Mean
1293933|NCT00095121|Secondary|Percentage of Participants With Durable HBeAg Seroconversion|A participant was defined to have durable HBeAg seroconversion only if she/he remained in a seroconverted state (HBeAg−, hepatitis B e antibody + [anti-HBe+]) from the date that she/he first seroconverted through and including her/his last study visit. This endpoint could only be assessed for participants who (HBeAg−) seroconverted on-treatment and subsequently discontinued open-label dosing.|240 weeks|Participants who discontinued treatment because of confirmed HBeAg seroconversion in Weeks 49 to 240 were to remain in the study through Week 240 to monitor the durability of seroconversion. Any participant who formally stopped drug early and restarted, by definition, did not have durable HBeAg seroconversion.|||Percentage of participants|||Number
1293934|NCT00095121|Secondary|Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance) for Subjects Who Received Combination ADV + Lamivudine Therapy|Resistance surveillance was conducted at Week 240/last on-treatment study visit for all participants who had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR while on combination ADV + lamivudine treatment.|240 weeks|32/173 added lamivudine from Weeks 108 - 144. Last on-ADV sample through Week 240 analyzed; participant omitted from cumulative Week 240 analysis if HBV DNA <169 copies/mL at Week 240/last time point or stopped study drug but remained in study. 2 ADV-ADV participants had ADV/lamivudine-specific, conserved-site mutation, and counted 2x in table.|||Participants|||Number
1293935|NCT00095121|Secondary|Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance)|Resistance surveillance was conducted annually for all participants who remained on treatment and had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR. The last on-ADV sample for all participants in the study was analyzed in the cumulative Week 240 resistance surveillance analysis.|240 weeks|Last on-ADV sample through Week 240 was analyzed, and participant was excluded from the cumulative Week 240 analysis if HBV DNA value was < 169 copies/mL at Week 240/last time point or if participant discontinued study drug but remained in study. One ADV-ADV participant had an ADV-specific, conserved-site mutation and is counted twice in the table.|||Participants|||Number
1293936|NCT00095121|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 240 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)|Per protocol, participants could discontinue study medication due to HBeAg seroconversion and remain in the study in order to evaluate the durability of seroconversion. HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and anti-HBe+ post baseline.|ADV baseline to ADV Week 240|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
1293937|NCT00095121|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 192 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)|ADV baseline = 1st ADV-dose day = Week 0 for ADV-ADV group and Week 48 for PLB-ADV group. ADV week = windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). HBeAg loss is defined per individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and anti-HBe+ post baseline.|ADV baseline to ADV Week 192|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
1293938|NCT00095121|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss or Seroconversion by End of Blinded Treatment (Study Week 48; Randomized and Treated Analysis Set)|HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and hepatitis B e antibody + (anti-HBe+) post baseline.|Study Week 0 to Study Week 48 (double-blind period)|The randomized and treated analysis set included all participants who were randomized into the study and received at least one dose of study medication. For Week 48 data; if Week 48 was missing, Week 44 was carried forward; if Week 44 was missing, missing = failure.|||percentage of participants|||Number
1293939|NCT00095121|Secondary|Percentage of Participants With Normal ALT at ADV Week 240 (Missing = Failure)|Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV Week 240|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
1293940|NCT00095121|Secondary|Percentage of Participants With Normal ALT at ADV Week 192 (Missing = Failure)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV Week 192|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
1293953|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
1293941|NCT00095121|Secondary|Percentage of Participants With Normal ALT at Adefovir Baseline (Missing = Failure)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
1293942|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 240 for ALT||ADV baseline to ADV 240 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||U/L||Standard Deviation|Mean
1293943|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 192 for ALT|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV baseline to ADV 192 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||U/L||Standard Deviation|Mean
1293944|NCT00095121|Secondary|ADV Baseline ALT|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||U/L||Standard Deviation|Mean
1293945|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 240 for Serum HBV DNA||ADV baseline to ADV 240 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||log10 HBV DNA copies/mL||Standard Deviation|Mean
1293946|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 192 for Serum HBV DNA|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV baseline to ADV 192 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||log10 HBV DNA copies/mL||Standard Deviation|Mean
1293947|NCT00095121|Secondary|Adefovir (ADV) Baseline Serum HBV DNA|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||log10 HBV DNA copies/mL||Standard Deviation|Mean
1293948|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)||ADV Week 240|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
1293949|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV Week 192|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
1293950|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
1293951|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)||ADV Week 240|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
1293952|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV Week 192|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
1294061|NCT00094861|Secondary|Maximal Body Weight Loss|Maximal weight loss observed from Baseline through to Week 12.|Baseline through Week 12|Full analysis set with available data|||kilograms||Standard Deviation|Mean
1294062|NCT00094861|Secondary|Number of Participants Hospitalized||Baseline to Week 16|Full analysis set|||participants|||Number
1293954|NCT00095121|Primary|Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 1000 Copies/mL (Polymerase Chain Reaction [PCR]-Based Assay) and Normal Alanine Aminotransferase (ALT) at Week 48 (Missing = Failure)|In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver.|Week 48|All randomized participants who received >= 1 dose study medication. If either endpoint was missing a Week 48 value, Week 44 value was substituted and used in the combined endpoint. If participant did not have serum HBV DNA value at Weeks 44 and 48 or ALT value at Weeks 44 and 48, then participant was considered a failure for the Week-48 analysis.|||percentage of participants|||Number
1293955|NCT00095056|Secondary|Safety and Tolerability of Sitagliptin Over 54 Weeks|Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.|Week 0 through Week 54|All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs.|||Participants|||Number
1293956|NCT00095056|Primary|Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment|Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.|Week 0 through Week 12|All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs.|||Participants|||Number
1293957|NCT00094900|Secondary|Mean Change in Prednisone Dose||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/day||Standard Error|Mean
1293958|NCT00094900|Secondary|Mean Change in Prednisone Dose||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/day||Standard Error|Mean
1293959|NCT00094900|Secondary|Mean Change in Prednisone Dose||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/day||Standard Error|Mean
1293960|NCT00094900|Secondary|Mean Change in Prednisone Dose||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/day||Standard Error|Mean
1293961|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||swollen joints||Standard Error|Mean
1293962|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||swollen joints||Standard Error|Mean
1293963|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||swollen joints||Standard Error|Mean
1293964|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||swollen joints||Standard Error|Mean
1293965|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||tender joints||Standard Error|Mean
1293966|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||tender joints||Standard Error|Mean
1293967|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||tender joints||Standard Error|Mean
1294073|NCT00094835|Primary|Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2|The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population|||hours||Full Range|Median
1293968|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||tender joints||Standard Error|Mean
1293969|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||units on a scale||Standard Error|Mean
1293970|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||units on a scale||Standard Error|Mean
1293971|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||units on a scale||Standard Error|Mean
1293972|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||units on a scale||Standard Error|Mean
1293973|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mm/hour||Standard Error|Mean
1293974|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mm/hour||Standard Error|Mean
1293975|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mm/hour||Standard Error|Mean
1293976|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mm/hour||Standard Error|Mean
1293977|NCT00094900|Secondary|Mean Change in C-Reactive Protein||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/dl||Standard Error|Mean
1293978|NCT00094900|Secondary|Mean Change in C-Reactive Protein||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/dl||Standard Error|Mean
1293979|NCT00094900|Secondary|Mean Change in C-Reactive Protein||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/dl||Standard Error|Mean
1293980|NCT00094900|Secondary|Mean Change in C-Reactive Protein||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/dl||Standard Error|Mean
1293981|NCT00094900|Secondary|Mean Change in Serum Amyloid A||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/liter||Standard Error|Mean
1293982|NCT00094900|Secondary|Mean Change in Serum Amyloid A||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/liter||Standard Error|Mean
1293983|NCT00094900|Secondary|Mean Change in Serum Amyloid A||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/liter||Standard Error|Mean
1293984|NCT00094900|Secondary|Mean Change in Serum Amyloid A||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/liter||Standard Error|Mean
1293985|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 24 months|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mcg/L||Standard Error|Mean
1293986|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 12 months|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mcg/L||Standard Error|Mean
1293987|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 6 months|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mcg/L||Standard Error|Mean
1293988|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 3 months|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mcg/L||Standard Error|Mean
1293989|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 24 months|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||x 10^3 cells/microliter||Standard Error|Mean
1293990|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 12 months|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||x 10^3 cells/microliter||Standard Error|Mean
1293991|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 6 months|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||x 10^3 cells/microliter||Standard Error|Mean
1293992|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 3 months|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||x 10^3 cells/microliter||Standard Error|Mean
1293993|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 24 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1293994|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 20 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1293995|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 16 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1293996|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 12 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1293997|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 9 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1293998|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 6 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1293999|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 3 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294000|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 24 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294001|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 20 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294002|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 16 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294003|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 12 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294004|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 9 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294005|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 6 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Deviation|Mean
1294006|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 3 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294007|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
1294008|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 20 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
1294009|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 16 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
1294010|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
1294011|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 9 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
1294012|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
1294013|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
1294014|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
1294015|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 20 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
1294016|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 16 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
1294017|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
1295405|NCT00082407|Secondary|Change in Body Weight|Change in body weight from baseline to week 52.|baseline, week 52|Intent to Treat, computed from the patients having both baseline and week 52 data.|||kg||Standard Error|Least Squares Mean
1294018|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 9 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
1294019|NCT00094900|Secondary|Mean Change in Tender Joint Count.|Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
1294020|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
1294021|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294022|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294023|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294024|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294025|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294026|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294027|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294028|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294029|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294030|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294031|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294032|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294033|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294034|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294035|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294036|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294037|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294038|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294039|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294040|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294041|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294042|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294086|NCT00094809|Secondary|Febrile Neutropenia|Febrile neutropenia, Defined as a temperature ≥ 38.2 °C on a given day, with an ANC < 1.0 x 10^9/L recorded on the same day or the next day, during any of the first 4 cycles of treatment.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
1294043|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294044|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294045|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294046|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294047|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294048|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294049|NCT00094900|Primary|Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease|At the 24 month post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures: Patient's pain assessment, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Patient self-assessed disability, Acute phase reactant.|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||participants|||Number
1294050|NCT00094900|Primary|Mean Change in SAA|SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||mg/liter||Standard Error|Mean
1294051|NCT00094900|Primary|Mean Change in hsCRP|hsCRP change from baseline to 10 days.The high sensitivity C-reactive protein (hsCRP) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||mg/dl||Standard Error|Mean
1294052|NCT00094900|Primary|Mean Change in ESR|ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||mm/hour||Standard Error|Mean
1294053|NCT00094900|Primary|Mean Change in Daily Scores|Daily scores change from baseline to 10 days. The clinical daily diary scores (a composite score that included fever, rash, and arthritis/arthralgia, with each of the 3 symptoms scored from 0 [no symptom] to 4 [worst symptom], with an overall range score of 0–12).|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
1294054|NCT00094887|Secondary|Rate of Acute Chest Syndrome/Pneumonia Requiring Blood Transfusion||study duration|||||||
1294055|NCT00094887|Secondary|Length of Hospitalization From Admissions Defined by the Time of the Discharge Order is Written||study duration|||||||
1294056|NCT00094887|Secondary|Blood Chemistry Levels||every 24 hours for the first 5 days after start of treatment.|||||||
1294057|NCT00094887|Secondary|Need for Analgesics||baseline and throughout treatment.|||||||
1294058|NCT00094887|Secondary|Methemoglobin Levels||at 2,4,6, and 8 hours after the start of therapy and then every 24 hours while on therapy.|||||||
1294059|NCT00094887|Secondary|Vital Signs||At baseline, then every hour for the first 8 hours of therapy, followed by every 4 hours of therapy.|||||||
1294060|NCT00094887|Primary|Time to Resolution of Vaso-occlusive Pain Crisis (VOC)|"Time to VOC resolution was defined by:~Pain relief - Visual Analog Scale (VAS) pain scores of 6 or less, (6 as worst and 0 as best) Freedom from parenteral narcotic use, Ability to walk unless the subject was not able to walk for any reason other than acute VOC prior to the onset of crisis, Subject and/or family’s belief that the painful crisis could be managed at home with or without oral analgesic use, and the physician concurred with that assessment."|Up to 30 days|75 subjects were assigned to treatment with iNO and 75 subjects were assigned to treatment with placebo; all subjects were included in the ITT and Safety Populations. 142 subjects completed the study according to the protocol and 8 subjects (4 in each treatment group) did not complete the study according to protocol.|||Hours||95% Confidence Interval|Median
1294063|NCT00094861|Secondary|Maximal Eastern Cooperative Oncology Group (ECOG) Performance Status Increase|"Maximal increase from Baseline in Eastern Cooperative Oncology Group (ECOG) performance status. ECOG is a scale to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.~Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; Grade 5: Dead."|Baseline through Week 12|Full analysis set participants with available ECOG data|||units on a scale||Standard Deviation|Mean
1294064|NCT00094861|Secondary|Number of Participants With Unplanned Breaks in Radiotherapy|The number of participants with unplanned breaks in radiotherapy of ≥ 5 days or who discontinued radiotherapy during Week 1 to Week 6.|Week 1 to Week 6|Full analysis set|||participants|||Number
1294065|NCT00094861|Secondary|Number of Participants With Severe (Grade 3 or Higher) Dysphagia|"Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set|||participants|||Number
1294066|NCT00094861|Secondary|Maximal Dysphagia Grade|"The mean maximal grade of dysphagia for each participant during the study. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set participants with dysphagia assessments.|||grade||Standard Deviation|Mean
1294067|NCT00094861|Secondary|Duration of Grade 2 or Higher Dysphagia|"Duration of grade 2 or higher dysphagia was calculated in days from the onset (first occurrence of grade ≥ 2) to the resolution (grade ≤ 1 after the last grade ≥ 2) of dysphagia.~Participants with no assessments were assumed as having grade ≥ 2 dysphagia and with a duration of the mean duration of all participants."|Start of treatment through Week 16|Full analysis set|||days||Standard Deviation|Mean
1294068|NCT00094861|Primary|Number of Participants With Grade 2 or Higher Dysphagia|"Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set|||participants|||Number
1294069|NCT00094835|Primary|Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2|The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).|Cycle 2, Day 1, 24 hours post-dose|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.|||ng/mL||Standard Deviation|Mean
1294070|NCT00094835|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2|Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose.|Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.|||μg*hr/mL||Standard Deviation|Mean
1294071|NCT00094835|Primary|Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2|The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for three treatment groups for which the sample size was smaller than 3.|||hours||Standard Deviation|Mean
1294072|NCT00094835|Primary|Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2|The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population|||ng/mL||Standard Deviation|Mean
1294087|NCT00094809|Secondary|Dose Delay or Reduction for Any Reason|Dose delay or reduction in chemotherapy dose during the first 4 cycles for any reason|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
1294074|NCT00094835|Primary|Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1|The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).|Cycle 1, Day 3, 24 hours post-dose|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.|||ng/mL||Standard Deviation|Mean
1294075|NCT00094835|Primary|Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1|Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose.|Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.|||μg*hr/mL||Standard Deviation|Mean
1294076|NCT00094835|Primary|Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1|The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.|||hours||Standard Deviation|Mean
1294077|NCT00094835|Primary|Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1|The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population|||ng/mL||Standard Deviation|Mean
1294078|NCT00094835|Secondary|Percentage of Participants With an Overall Objective Response|Confirmed objective tumor response defined as a complete response (CR) or partial response (PR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Tumor response was evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI). Responding disease (CR or PR) was confirmed no less than 4 weeks after the criteria for response were first met. A complete response defined as the disappearance of all target lesions and all non-target lesions, no new lesions and normalization of tumor marker level. Partial response defined as either the disappearance of all target lesions and the persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diamer (LD) of target lesions, taking as reference the baseline sum LD and no new lesions and/or unequivocal progression of existing non-target lesions.|After 9 weeks of treatment (at the end of Cycle 3)|Efficacy analysis set, composed of all enrolled participants who received at least one dose of motesanib in treatment arms 1-3 or at least one dose of motesanib with one dose of panitumumab in treatmnt arms 4-7.|||Percentage of participants|||Number
1294079|NCT00094835|Primary|Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1|The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|The pharmacokinetic (PK) population consisted of all consented patients who received motesanib and had evaluable pharmacokinetic data and did not have significant protocol deviations that affected the data or key-dosing information that was missing.|||hours||Full Range|Median
1294080|NCT00094809|Primary|Grade 4 Neutropenia|Grade 4 neutropenia, defined as an absolute neutrophil count (ANC) <0.5 x 10^9/L, in any of the first four cycles of treatment|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
1294081|NCT00094809|Secondary|Antibiotic Use Due to Febrile Neutropenia|Antibiotic use during any of the first 4 cycles of treatment due to febrile neutropenia.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
1294082|NCT00094809|Secondary|Survival|Death from any cause through the end of the follow-up period|Up to 24 months after first four cycles of treatment|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures.|||Participants|||Number
1294083|NCT00094809|Secondary|Objective Tumor Response|Objective tumor response (complete or partial) at the end of treatment, defined as a reduction of at least 50% in the area of all measurable lesions (partial response) or disappearance of all measurable or evaluable disease without the development of new lesions (complete response) on computed tomographic (CT) or other scanning.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
1294084|NCT00094809|Secondary|Progression-Free Survival|Kaplan-Meier estimate of the median time to disease progression or death|Up to 24 months after first four cycles of treatment|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Days||95% Confidence Interval|Median
1294085|NCT00094809|Secondary|Hospitalization Due to a Neutropenia-Related Event|Hospitalization because of a neutropenia-related event during the first 4 cycles of treatment|First 4 cycles of neutropenia (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
1294088|NCT00094809|Secondary|Dose Delay or Reduction Due to Neutropenia|Dose delay or reduction in chemotherapy doses due to neutropenia|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
1294089|NCT00094809|Primary|Grade 3 or 4 Neutropenia|Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) < 1 x 10^9/L, in any of the first four cycles of treatment|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
1294090|NCT00094770|Secondary|Number of Participants With Drug-related LAEs at Week 104|Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1294091|NCT00094770|Secondary|Number of Participants With Serious LAEs at Week 104|Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1294092|NCT00094770|Secondary|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1294093|NCT00094770|Secondary|Number of Participants With Drug-related CAEs at Week 104|Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1294094|NCT00094770|Secondary|Number of Participants With Serious CAEs at Week 104|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1294095|NCT00094770|Secondary|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1294096|NCT00094770|Secondary|Hypoglycemic Events at Week 104|Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1294097|NCT00094770|Secondary|Hypoglycemic Events at Week 52|Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.|Baseline to Week 52|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
1294098|NCT00094770|Secondary|Change From Baseline in Body Weight at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Baseline and Week 104|The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.|||Kilograms||95% Confidence Interval|Least Squares Mean
1294099|NCT00094770|Secondary|Change From Baseline in Body Weight at Week 52|Change from baseline at Week 52 is defined as Week 52 minus Week 0.|Baseline and Week 52|The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.|||Kilograms||95% Confidence Interval|Least Squares Mean
1294100|NCT00094770|Secondary|Change From Baseline in HbA1c at Week 104|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 104|The per protocol population required that a participant had measurements both at baseline and at Week 104, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.|||Percent||95% Confidence Interval|Least Squares Mean
1294101|NCT00094770|Primary|Change From Baseline in HbA1c at Week 52|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 52|The per protocol population required that a participant had measurements both at baseline and at Week 52, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.|||Percent||95% Confidence Interval|Least Squares Mean
1294102|NCT00094757|Secondary|Change From Baseline in FPG at Week 54|The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.|Weeks 0-54|All Patients Treated included patients who received at least 1 dose of study therapy 1 post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.|||mg/dL||95% Confidence Interval|Least Squares Mean
1294103|NCT00094757|Secondary|Change From Baseline in A1C at Week 54|A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.|Weeks 0-54|All Patients Treated included patients who received at least 1 dose of study therapy post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.|||percent||95% Confidence Interval|Least Squares Mean
1294104|NCT00094757|Secondary|Change From Baseline in FPG at Week 18|The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.|Weeks 0-18|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 18 for patients with no data at Week 18. Data after initiation of glycemic rescue were considered missing.|||mg/dL||95% Confidence Interval|Least Squares Mean
1294105|NCT00094757|Primary|Change From Baseline in A1C at Week 18|Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Weeks 0-18|All Patients Treated included those with ≥1 dose of study therapy, had a baseline and ≥1 post-baseline value. For those with no data at Week 18, last post-baseline observation was carried forward. Data after initiation of glycemic rescue were considered missing. Analysis adjusted for baseline values and prior antihyperglycemic therapy status.|||percent||95% Confidence Interval|Least Squares Mean
1294106|NCT00094653|Secondary|Clinically Meaningful Changes in Vital Signs and Physical Examinations|Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure.|vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter|All subjects who received at least 1 dose or any partial dose of study medication.|||participants|||Number
1294107|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Renal Abnormalities|CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.|||percentage of participants|||Number
1294108|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Liver Abnormalities|ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.|||percentage of participants|||Number
1294109|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Hematological Abnormalities|ANC=Absolute Neutrophil Count. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.|||percentage of participants|||Number
1294110|NCT00094653|Secondary|Percentage of Participants With Immune-Related Adverse Events (irAEs)|"An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of Other irAEs includes blood, eye, immune, infections, renal, and respiratory systems."|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication.|||percentage of participants|||Number
1294111|NCT00094653|Secondary|Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death|An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication.|||percentage of participants|||Number
1294112|NCT00094653|Secondary|Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12|The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).|Baseline (Day 1, Cycle1), Week 12|All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.|||units on a scale||95% Confidence Interval|Least Squares Mean
1294113|NCT00094653|Secondary|Delayed Response (Response Beyond Week 24)|Response was based on the investigators' assessment using modified World Health Organization (WHO) criteria. Delayed response is defined as post Week 24 overall response for the subjects who have PD before or at Week 24. Evaluation of delayed overall response is compared to baseline assessment. Delayed response includes delayed late CR, delayed late PR, delayed late SD, continued PD, unknown, and missing after Week 24. The delayed response of CR and PR also must have been confirmed.|from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Number of subjects with BOR of PR/SD (80 subjects ipi + gp100 , 37 ipi , 15 gp100) plus number of subjects with BOR of PD that had subsequent evaluation (8 ipi + gp100, 3 ipi, 3 gp100).|||participants|||Number
1294137|NCT00094497|Secondary|Number of Disease-free Patients|complete response or disease-free by time of surgery|every 8 weeks until progression (up to 5 years)||||participants|||Number
1294138|NCT00094497|Secondary|Best Overall Response Rate|RECIST 1.0 was used to evaluate response|every 8 weeks up to 5 years||||participants|||Number
1294114|NCT00094653|Secondary|Disease Control Rate (DCR)|Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group.|Up to week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Number
1294115|NCT00094653|Secondary|Duration of Response|Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first).|from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Responders only in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Patients who did not progress or died were censored at the date of their last tumor assessment.|||months||95% Confidence Interval|Median
1294116|NCT00094653|Secondary|Time to Response|Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Responder subjects in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||months||Full Range|Mean
1294117|NCT00094653|Secondary|Determination of Best Overall Response Rate (BORR)|Response was based on the investigators’ assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated.|Up to week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Number
1294118|NCT00094653|Secondary|Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)|Investigator’s assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations >=4 weeks apart, no evidence of PD. PR: >=50% ↓ in sum of products of longest diameter & greatest perpendicular diameter of all target lesions compared to baseline by 2 observations >=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ >=25% in sum of products of longest diameter & greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of >= 1 new lesion.|BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||participants|||Number
1294119|NCT00094653|Secondary|Time to Progression (TTP)|TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death.|from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
1294120|NCT00094653|Secondary|Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24|PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|Week 12, Week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Median
1294121|NCT00094653|Secondary|Progression Free Survival (PFS)|PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Subjects who neither progressed nor died were censored at the date of the last tumor assessment.|||months||95% Confidence Interval|Median
1294122|NCT00094653|Secondary|12-, 18-, and 24-Month Survival Rates|The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.|Month 12, Month 18, Month 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||probability||95% Confidence Interval|Number
1294123|NCT00094653|Secondary|Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy|OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
1294139|NCT00094497|Secondary|Change in Quality of Life as Measured by QLQ-C30|scale ranged from 0 to 100 with higher score meaning greater quality of life|baseline and 8 weeks|participants with data on both time points|||units on a scale||Standard Deviation|Mean
1294140|NCT00094497|Secondary|Progression-free Survival||every 8 weeks until progression or death up to 5 years||||months||95% Confidence Interval|Median
1294124|NCT00094653|Primary|Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone|OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
1294125|NCT00094575|Secondary|International Index of Erectile Function (IIEF-5)|"Change (over time) since baseline in IIEF-5. The IIEF-5 Score ranges from 5-25 with higher scores indicating better erectile function.~Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
1294126|NCT00094575|Secondary|European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale|"Change (over time) since baseline in EQ-5D Visual Analog Scale. The EQ-5D Visual Analog Scale ranges from 0 (death) to 1 (perfect health). Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
1294127|NCT00094575|Secondary|European Quality of Life-5 Dimension (EQ-5D) Index Score|"Change (over time) since baseline in EQ-5D. The EQ-5D Index Score ('thermometer scale') ranges from 0 (worst health status) to 100 (best health status). Since this outcome captures change since baseline, values could be below 0.~Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
1294128|NCT00094575|Secondary|SF-36 Physical Component Deaths Included Score (PCTD)|"Change (over time) since baseline in Physical Component Deaths included Score of SF-36.~The PCTD Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
1294129|NCT00094575|Secondary|SF-36 Physical Component Score (PCS)|"Change (over time) since baseline in Physical Component Score of SF-36. The PCS Score ranges from 0-100 with higher scores indicating better health Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
1294130|NCT00094575|Secondary|SF-36 Mental Component Score (MCS)|"Change (over time) since baseline in Mental Component Score of SF-36. The MCS Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and then yearly, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
1294131|NCT00094575|Secondary|Secondary Therapeutic Procedures|This outcome includes any procedure that resulted directly or indirectly from the initial procedure and that required a separate trip to the procedure suite (with each trip to the procedure suite counting as one secondary procedure), including any unplanned surgical procedures within 30 days after the initial procedure and any additional aortoiliac procedures at any time.|Participants were followed for the duration of the study, up to 9 years||||participants|||Number
1294132|NCT00094575|Primary|All-cause Mortality|Participants vital status was assessed from randomization to end of study follow-up [10/15/2011] or death [whichever occurred first].|Participants were followed for the duration of the study, up to 9 years||||participants|||Number
1294133|NCT00094536|Primary|Success (Reduction in Menstruation to Normal Levels)|Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.|1 Year|Intention-to-Treat Analysis|||Participants|||Count of Participants
1294134|NCT00094497|Other Pre-specified|Impact of Reaching Mitotane Blood Levels Between 14-20 mg/l in Both Arms on Survival and Overall Response Rate||every 8 weeks until progression or until Dec 2010|||||||
1294135|NCT00094497|Other Pre-specified|Pharmakinetics of Mitotane (Substudy)|To study the relationship between mitotane dose (daily and cumulative) and mitotane plasma concentrations using one of two pre-defined treatment regimens (high-dose and low-dose).|11 time points in the first 12 weeks|||||||
1294136|NCT00094497|Other Pre-specified|TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime||every 8 weeks until progression or until Dec 2010|||||||
1294142|NCT00094458|Secondary|Average Corticosteroid Use|Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)|Weeks 2, 6, 10, 18 and 26|Population analyzed included all randomized participants taking corticosteroids for Crohn’s disease. n' signifies number of participants who were evaluable at specified time point, for each arm respectively.|||milligram per day||Standard Deviation|Mean
1294143|NCT00094458|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)|Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).|Baseline and Weeks 2, 6, 10, 18, 26|Population analyzed included all randomized participants enrolled in Main Study with last observation carried forward method to impute missing data. 'n' signifies number of participants who were evaluable at specified time point, for each arm respectively.|||units on a scale||Standard Deviation|Mean
1294144|NCT00094458|Secondary|Percentage of Participants With Clinical Response Over Time (Study Extension)|Clinical response, defined as a >=100-point decrease in CDAI from Baseline.|Weeks 34, 42, 50|Population analyzed included all randomized participants during the Study Extension.|||percentage of participants|||Number
1294145|NCT00094458|Secondary|Percentage of Participants With Clinical Response Over Time (Main Study)|Clinical response, defined as a >=100-point decrease in CDAI from Baseline.|Weeks 2, 6, 10, 18, 26|Population analyzed included all randomized participants during the Main Study.|||percentage of participants|||Number
1294146|NCT00094458|Secondary|Percentage of Participants With Clinical Remission (Study Extension)|Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)|Weeks 34, 42 and 50|Population analyzed included all randomized participants enrolled in the Study Extension.|||percentage of participants|||Number
1294147|NCT00094458|Secondary|Percentage of Participants With Clinical Remission (Main Study)|Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)|Weeks 2, 6, 10, 18 and 26|Population analyzed included all randomized participants enrolled in the main study.|||percentage of participants|||Number
1294148|NCT00094458|Secondary|Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)|Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) < 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for >= 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).|Week 50|Population analyzed included all randomized participants enrolled in Study Extension.|||percentage of participants|||Number
1294149|NCT00094458|Secondary|Percentage of Participants With Mucosal Healing|Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.|Week 26|Analysis population for mucosal healing was per protocol. All subjects with lesions at Baseline (Week 0) and an Endoscopy at Week 26 were included in the analysis. Here, ‘N’ [number of participants analyzed] signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1294150|NCT00094458|Primary|Percentage of Participants With Corticosteriod-free Clinical Remission|Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (>=) 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).|Week 26|Intention to treat (ITT) population includes all randomized participants in the analysis, according to the treatment group to which they were randomized, regardless of the treatment they actually received.|||percentage of participants|||Number
1294151|NCT00094328|Secondary|Change in Average Testicular Volume|Testicular volume of both testes was measured using either ultrasound or an orchidometer. Testicular volume was measured at baseline and at 6 and 12 months. The change in testicular volume from baseline was calculated for the left and right testicle as well as the average across both testes by subtracting the baseline volume from the volumes at 6 and 12 months within each patient.|Assessed after 6 and 12 months of treatment|All treated (AT) set|||mL||Standard Deviation|Mean
1294152|NCT00094328|Secondary|Change in Predicted Adult Height (PAH)|Radiographs are used to assess the bone age, the change in predicted adult height (PAH) is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH is be calculated by subtracting the PAH at baseline from the PAH at 12 months.|Assessed after 12 months treatment|Calculated on All treated analysis set, however, if bone age is less than 6 years or bone age is less than 7 years and bone age>=(chronological age-1) then PAH cannot be calculated using the Bayley and Pinneau method.|||cm||Standard Deviation|Mean
1294153|NCT00094328|Secondary|Number of Patients With Height Between 5th and 95th Percentile|The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.|Assessed after 3, 6, 9 and 12 months of treatment|All treated (AT) set|||Participants|||Number
1294154|NCT00094328|Secondary|Change in Bone Age to Chronological Age Ratio|Change in bone age to chronological age ratio after 6 and 12 months treatment relative to the baseline ratio for all patients.|Assessed after 6 and 12 months of treatment|All treated (AT) set|||Ratio||Standard Deviation|Mean
1294155|NCT00094328|Secondary|Change in Bone Age Maturation Rate (cm/Year)|Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation after 6 months of treatment was calculated relative to the rate of change in bone age during the ≥ 6 months pre-study period.|Assessed after 6 and 12 months treatment|Calculated on All treated analysis set for those patients who had a 6-month pre study radiograph.|||cm/year||Standard Deviation|Mean
1294156|NCT00094328|Secondary|Change in Growth Rate (SD Units)|Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period.|Assessed after 6 months treatment|All treated (AT) set|||SD units||Standard Deviation|Mean
1294157|NCT00094328|Secondary|Change in Growth Rate (cm/Year)|Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period.|Assessed after 6 months treatment|All treated (AT) set|||cm/year||Standard Deviation|Mean
1294160|NCT00094302|Secondary|Estimated Glomerular Filtration Rate (GFR)|Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mL/min/1.73m2||Standard Error|Least Squares Mean
1294161|NCT00094302|Secondary|Chloride|Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mEq/L||Standard Error|Least Squares Mean
1294162|NCT00094302|Secondary|Sodium|Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mEq/L||Standard Error|Least Squares Mean
1294163|NCT00094302|Secondary|Serum Creatinine|Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mg/dL||Standard Error|Least Squares Mean
1294164|NCT00094302|Secondary|Potassium|Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mEq/L||Standard Error|Least Squares Mean
1294165|NCT00094302|Secondary|Hospitalization for Any Reason|First incidence of a hospitalization for any reason|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294166|NCT00094302|Secondary|Depression Symptoms, as Measured by Patient Health Questionnaire.|"Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants from the United States and Canada who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||units on a scale||Standard Error|Least Squares Mean
1294167|NCT00094302|Secondary|Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.|"Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.~The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition? Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants from United States, Canada and Argentina who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||units on a scale||Standard Error|Least Squares Mean
1294168|NCT00094302|Secondary|Quality of Life, as Measured by the EuroQOL Visual Analog Scale.|"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||units on a scale||Standard Error|Least Squares Mean
1294446|NCT00090857|Secondary|Worst Grade Nausea|Participants reported worst grade nausea grade 01: able to eat, 02: oral intake significantly decreased, 03: no significant intake, requiring IV fluids during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.|||Participants|||Count of Participants
1294169|NCT00094302|Secondary|Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.|"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||units on a scale||Standard Error|Least Squares Mean
1294170|NCT00094302|Secondary|Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294171|NCT00094302|Secondary|Deterioration of Renal Function|First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294172|NCT00094302|Secondary|Stroke|First incidence of stroke|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294173|NCT00094302|Secondary|Myocardial Infarction|First incidence of myocardial infarction|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294174|NCT00094302|Secondary|Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.|First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized and did not have a history of atrial fibrillation at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294175|NCT00094302|Secondary|New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.|First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized and did not have a history of diabetes mellitus at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294176|NCT00094302|Secondary|Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294177|NCT00094302|Secondary|Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294178|NCT00094302|Secondary|Cardiovascular-related Hospitalization|Hospitalization for MI, stroke or the management of heart failure, whichever occurred first|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294179|NCT00094302|Secondary|Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294180|NCT00094302|Secondary|All-cause Mortality||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1295786|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1294181|NCT00094302|Secondary|Hospitalization for the Management of Heart Failure|First incidence of a hospitalization for the management of heart failure|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294182|NCT00094302|Secondary|Aborted Cardiac Arrest|First incidence of aborted cardiac arrest|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294183|NCT00094302|Secondary|Cardiovascular Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294184|NCT00094302|Primary|Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
1294185|NCT00094172|Secondary|Proportion of Participants Diagnosed With Multiple Sclerosis According to the McDonald Criteria|"Number of participants diagnosed with Multiple Sclerosis (MS) according to the McDonald criteria[1]~The McDonald criteria uses dissemination in time and space[2] established by Magnetic Resonance Image (MRI) findings to provide a clinical diagnosis for MS~Dissemination in time is established by a new T2 or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. The presence of any 3 of the following establishes dissemination in space: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; ≥1 infratentorial lesion; ≥1 juxtacortical lesion; ≥3 periventricular lesions"|18 months post-randomization|Intent-to-Treat|||Participants|||Number
1294186|NCT00094172|Secondary|Proportion of Participants Who Are Diagnosed With Multiple Sclerosis According to the McDonald Criteria|"Number of participants diagnosed with Multiple Sclerosis (MS) according to the McDonald criteria[1]~The McDonald criteria uses dissemination in time and space[2] established by Magnetic Resonance Image (MRI) findings to provide a clinical diagnosis for MS~Dissemination in time is established by a new T2 or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. The presence of any 3 of the following establishes dissemination in space: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; ≥1 infratentorial lesion; ≥1 juxtacortical lesion; ≥3 periventricular lesions"|12 months post-randomization|Intent-to-Treat|||Participants|||Number
1294187|NCT00094172|Primary|The Occurrence of ≥ 3 New T2 Lesions With or Without Gd+ Enhancement or Clinical Exacerbation Through 12 Months.|"The occurrence of ≥ T2 lesions[1] with or without gadolinium lesion (Gd+) enhancement[2] or clinical exacerbation[3] through 12 months. A higher score indicates more severe disease~A new T2 lesion is an abnormal, hyperintense white-matter area visible on T2 weighted images that were not present on the baseline scan~A Gd+ enhancement is defined as a contrast enhancement visible on a new T2 lesion~A clinical exacerbation is a new neurological symptom that lasts more than 48 hours in a participant who has been neurologically stable for 30 days following start of study medication"|12 months post-randomization|Intent-to-Treat|||Participants|||Number
1294188|NCT00094107|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 147 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.|||Ratio||Standard Deviation|Mean
1294189|NCT00094107|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 147 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.|||ng/mL||Standard Deviation|Mean
1294190|NCT00094107|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1294226|NCT00093756|Secondary|Progression-free Survival|The distribution of progression-free survival (PFS) is defined as the time from registration to the time of progression or death, whichever comes first. The PFS will be estimated using the method of Kaplan-Meier.|From study registration to the first of either death due to any cause or progression, up to 5 years|All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.|||months||95% Confidence Interval|Median
1294191|NCT00094107|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
1294192|NCT00094107|Secondary|Progression-free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 147 weeks|Study population included all participants who received at least 1 dose of study medication and had at least one baseline efficacy assessment.|||Days||95% Confidence Interval|Median
1294193|NCT00094107|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 weeks|Study population included all participants who received at least 1 dose of study medication and had at least one baseline efficacy assessment.|||Percentage of participants||95% Confidence Interval|Number
1294194|NCT00094094|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 98 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.|||Ratio||Standard Deviation|Mean
1294195|NCT00094094|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 98 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1294196|NCT00094094|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who enrolled and received treatment.|||Days||95% Confidence Interval|Median
1294197|NCT00094094|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
1294198|NCT00094094|Secondary|Progression-Free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 98 weeks|Study population included all participants who enrolled and received treatment.|||Days||95% Confidence Interval|Median
1294199|NCT00094094|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks|Study population included all participants who enrolled and received treatment.|||Percentage of participants||95% Confidence Interval|Number
1294200|NCT00094055|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 206 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.|||Ratio||Standard Deviation|Mean
1294201|NCT00094055|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 206 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1294202|NCT00094055|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|ITT population included all participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1294203|NCT00094055|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks|Subgroup of participants from the ITT population with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
1294204|NCT00094055|Secondary|Progression-Free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks|ITT population included all participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1294205|NCT00094055|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks|Intent to treat (ITT) population included all participants who received at least 1 dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1294206|NCT00093847|Secondary|HDRS17 Responders|35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .|Measured at Week 6|ITT LOCF|||Percentage of Responders HDRS17|||Number
1294207|NCT00093847|Primary|Hamilton Depression Rating Scale Remission Rates|The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .|Measured at Week 6|ITT LOCF|||Percentage of Remitters HDRS17|||Number
1294208|NCT00093808|Secondary|Overall Survival as Assessed by Time|Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.|||months||95% Confidence Interval|Median
1294209|NCT00093808|Secondary|Duration of Response as Measured by RECIST Criteria|Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.|||months||95% Confidence Interval|Median
1294227|NCT00093756|Secondary|Time to Progression|The distribution of time to progression will be estimated using the method of Kaplan-Meier.|From study registration to date of disease progression or date of last follow-up, up to 5 years|Study team decision not to run this analysis.||||||
1294447|NCT00090857|Secondary|Worst Grade Muscle Aches/Pains|Participants reported worst grade muscle aches/pains defined as grade 01: mild, 02: moderate, 03: severe (CTCAEv3) or 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.||||Participants|||Count of Participants
1294210|NCT00093808|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for any evaluations, that patient will be censored for progression of disease at day one post-registration. Otherwise, for patients that do not progress, censoring will occur at the last follow up date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or unequivocal progression of existing non-target lesions.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.|||months||95% Confidence Interval|Median
1294211|NCT00093808|Primary|Confirmed Response Rate|A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|Patients who completed the study were included in all analyses unless otherwise specified.|||proportion of patients||95% Confidence Interval|Number
1294212|NCT00093795|Secondary|Toxicity|Percentage of patients who ever experienced grade 2 or higher toxicities.|30 days after the last dose of study therapy (about 7 months after study entry)|For Arm 1 there is no follow-up data for 23 participants; for Arm 2 there is no follow-up data for 11 participants; and for Arm 3 there is not follow-up data for 18 participants.|||percentage of patients||95% Confidence Interval|Number
1294213|NCT00093795|Secondary|Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only|Percentage of patients distant recurrence-free (no distant disease recurrence only)|5 years|For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.|||percentage of patients||95% Confidence Interval|Number
1294214|NCT00093795|Secondary|Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence|Percentage of patients recurrence-free (no first local, regional, or distant recurrence)|5 years|For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.|||percentage of patients||95% Confidence Interval|Number
1294215|NCT00093795|Secondary|Overall Survival|Percentage of participants alive at 5 years|5 years|For Arm 1 there is no follow-up data for 13 participants; for Arm 2 there is no follow-up data for 10 participants; and for Arm 3 there is no follow-up data for 12 participants.|||percentage of patients alive||95% Confidence Interval|Number
1294216|NCT00093795|Primary|Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer|The percentage of patients alive and cancer-free.|5 years|For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.|||percentage of patients||95% Confidence Interval|Number
1294217|NCT00093782|Secondary|Time to Progression||Up to 8 years|At the time of publication, 5 patients were still on treatment and analysis was done on 31 patients|||months||95% Confidence Interval|Median
1294218|NCT00093782|Secondary|Number of Temsirolimus Treatment Cycle Analyzed for Toxicity|Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3|Duration of participants treatment upto 16wks (4cycles) of treatment||||treatment cycles|||Number
1294219|NCT00093782|Secondary|Response and Stable Disease|Assessed using RECIST criteria.Patients that had Stable disease for 2 months|2 months|Number of patients that had stable disease for 2 months|||patients|||Number
1294220|NCT00093782|Secondary|Survival Rate|Computed using the Kaplan-Meier method.|1 year|Out of the 25 patients alive as of Jan 2006|||percentage of participants||95% Confidence Interval|Number
1294221|NCT00093782|Secondary|Median Survival Time|Computed using the Kaplan-Meier method.|3|Out of the 25 patients alive (in 2006 at time of publication)|||months||95% Confidence Interval|Median
1294222|NCT00093782|Secondary|Stable Disease Rate Defined by RECIST Criteria|Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 8 years||||participants|||Number
1294223|NCT00093782|Primary|Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 8 years||||participants|||Number
1294224|NCT00093756|Secondary|Frequency and Severity of Observed Toxicity, Graded by Common Terminology Criteria for Adverse Events (CTCAE)|Toxicity was reported after the first 21 days of treatment and after each 28 day cycle thereafter. Events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. The number of patients reporting grade 3 and higher are tabulated.|Up to 5 years|All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.|||Participants|||Count of Participants
1294225|NCT00093756|Secondary|Overall Survival|Overall Survival is defined as the time from registration to the time to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, up to 5 years|All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.|||months||95% Confidence Interval|Median
1294228|NCT00093756|Secondary|Confirmed Tumor Response|Response was assessed using the RECIST v1.1 criteria. Patients were evaluated at 4 weeks post-RT, 3 months post-RT, every 3 months for 1 year post-RT, and every 6 months thereafter for a maximum of 5 years from time of registration. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart.|Up to 5 years|All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.|||Participants|||Count of Participants
1294229|NCT00093756|Primary|The Primary Endpoint of This Trial is the Proportion of Patients Alive at 1 Year. Phase II Patients Only.|The primary endpoint of this trial is the proportion of patients alive at 1 year (i.e., 365 days) after study registration. Proportion of successes, defined as the number of patients alive at one year divided by the total number of evaluable patients.|At 1 year|This analysis included all 21 patients enrolled in the Phase II portion of the study and 6 patients enrolled in the Phase I who were treated at the Phase II dose level.|||proportion of Participants|||Number
1294230|NCT00093496|Secondary|Toxicity|Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.|Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)|In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for adverse events.|||events|||Number
1294231|NCT00093496|Secondary|Overall Survival|Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.|Every 3 months until disease progression and then every 6 months for up to 5 years.|An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical acttivity, the interim analysis for Cohort 2 was conducted on the first 11 participants.|||months||95% Confidence Interval|Median
1294232|NCT00093496|Secondary|Times to Progression|Defined as the time from registration to the date of progression or last follow-up, whichever comes first. Estimated using the method of Kaplan-Meier|Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.|An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical activity, the interim analysis for Cohort 2 was conducted on the first 11 participants.|||months||95% Confidence Interval|Median
1294233|NCT00093496|Primary|Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.|"Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline."|Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).|In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for the primary endpoint.|||proportion of participants|||Number
1294234|NCT00093470|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death from any cause.|Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.|All randomized patients|||months||95% Confidence Interval|Median
1294235|NCT00093470|Primary|Disease-free Survival|Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.|Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.|All randomized patients|||months||95% Confidence Interval|Median
1294236|NCT00093379|Secondary|Number of Participants With Progression-Free Survival at 2-Year||2 Years|||||||
1294237|NCT00093379|Secondary|2-Year Median Overall Survival||2 Years|||||||
1294238|NCT00093379|Secondary|2-year Local Regional Control||2 Years|||||||
1294239|NCT00093379|Secondary|Number of Participants With 2-year Colostomy-Free Survival|Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.|2 Years with median study follow up of 19 months||||participants|||Number
1294240|NCT00093379|Secondary|Number of Participants With Complete Response at 2 Years|Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|2 Years|Three (3) participants were not evaluable for response.|||participants|||Number
1294241|NCT00093379|Primary|2 Year Failure Free Survival|Treatment failure defined as: Biopsy proven residual disease identified 12 –14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.|2 years||||participants|||Number
1294280|NCT00092547|Secondary|Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males|The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.|Up to Month 126|Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.|||Cases per 100 person-years at risk||95% Confidence Interval|Number
1294242|NCT00093145|Secondary|Number of Participants With Adverse Events (AEs)|A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above|Day 1 up to 39 cycles|Treated population|||participants|||Number
1294243|NCT00093145|Secondary|Overall Patient Survival|Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods.|From Day 1 until approximately 44 months.|Treated population|||months||95% Confidence Interval|Median
1294244|NCT00093145|Secondary|Duration of Response|Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Assessed every 2 cycles, up to a maximum of 39 cycles.|Treated Population - Patients with a Confirmed Complete or Partial Overall Response|||months||95% Confidence Interval|Median
1294245|NCT00093145|Secondary|Time to Disease Progression|Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods.|Assessed every 2 cycles, up to a maximum of 39 cycles.|Treated population|||months||95% Confidence Interval|Median
1294246|NCT00093145|Secondary|Percentage of Participants With a Total Response|Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Evaluated every 2 cycles, up to a maximum of 39 cycles.|Treated population|||percentage of participants||95% Confidence Interval|Number
1294247|NCT00093145|Primary|Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response|Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.|Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)|The treated population consisted of all randomized participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1294248|NCT00093041|Secondary|Overall Response, Classification|Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16.|8 weeks||||participants|||Number
1294249|NCT00093041|Primary|Adverse Events|Number of participants reporting at least one adverse event|Overall Study|Number of participants reporting at least one adverse event|||participants|||Number
1294250|NCT00093015|Secondary|Time to Hospitalization Due to Acute Myocardial Ischemia|Time from randomization to hospitalization due to acute myocardial ischemia. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294251|NCT00093015|Secondary|Change in Patient Reported Fatigue Relative to Baseline at Week 25|Change in patient reported fatigue measured by the Functional Assessment of Cancer Therapy (FACT) – Fatigue scale from baseline to week 25. Range and direction of scale: 0 = most fatigue; 52 = least fatigue|Baseline and week 25|Subjects with both the baseline and at least post-baseline measurement at week 25 for FACT-fatigue were included in the analysis and were analyzed as randomized. Last observation carried forward (LOCF) using last non-missing post-baseline value was used for missing post-baseline data for subjects who were still on study.|||Units on a scale||Standard Deviation|Mean
1295787|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1294252|NCT00093015|Secondary|Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline|GFR was estimated using the following MDRD formula: 186 x [Serum creatinine]^(-1.154) x [Age]^(-0.203) x [0.742 if subject is female] x [1.210 if subject is black]. Change from baseline in eGFR at week 49 for each treatment group are presented. The treatment effect of the rate of decline in eGFR per year was estimated using the mixed model.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|Subjects were analyzed as randomized using all available eGFR measurements, except eGFR measurements measured after subjects develop ESRD since creatinine measurements were no longer reliable or meaningful for eGFR calculation.|||mL/min/1.73m^2||Standard Deviation|Mean
1294253|NCT00093015|Secondary|Time to End Stage Renal Disease|Time from randomization to end stage renal disease (ESRD). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294254|NCT00093015|Secondary|Time to Congestive Heart Failure|Time from randomization to fatal or non-fatal congestive heart failure(CHF). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294255|NCT00093015|Secondary|Time to Cerebrovascular Accident|Time from randomization to fatal or non-fatal cerebrovascular accident (CVA). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294256|NCT00093015|Secondary|Time to Myocardial Infarction|Time from randomization to fatal or non-fatal myocardial infarction (MI). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294257|NCT00093015|Secondary|Time to Cardiovascular Mortality|Time from randomization to cardiovascular (CV) mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294258|NCT00093015|Secondary|Time to All-cause Mortality|Time from randomization to all-cause mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294259|NCT00093015|Primary|Time to All-cause Mortality or End Stage Renal Disease (ESRD)|Time from randomization to first event of all-cause mortality or ESRD. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294260|NCT00093015|Primary|Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)|Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
1294261|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Triglycerides From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.|||Percent Change||Standard Deviation|Mean
1294262|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average High-density Lipoprotein Cholesterol (HDL-C) From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.|||Percent change||Standard Deviation|Mean
1294263|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.|||Percent Change||Standard Deviation|Mean
1294264|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Total Cholesterol From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.|||Percent Change||Standard Deviation|Mean
1294265|NCT00092677|Secondary|Change From Baseline in Peak Transaortic Jet Velocity|Mean change from baseline in peak transaortic jet velocity|Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication. 180 patients were excluded from peak transaortic jet velocity due to missing measurements.|||m/sec||Standard Deviation|Mean
1294266|NCT00092677|Post-Hoc|Incident Cancer|Number of participants with incident cancer|Entire follow-up (median = 4.35 years)|One patient from the 944 patients randomized to ezetimibe/simvastatin 10/40 mg did not receive study medication and was not included.|||Participants|||Number
1294267|NCT00092677|Post-Hoc|Death Due to Cancer|Number of participants that died due to cancer|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294268|NCT00092677|Other Pre-specified|Death (Any Cause)|Number of participants that died (any cause)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294269|NCT00092677|Other Pre-specified|Nonhemorrhagic Stroke|Number of participants that experienced nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294270|NCT00092677|Other Pre-specified|Hospitalization for Unstable Angina|Number of participants that experienced hospitalization for unstable angina|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294271|NCT00092677|Other Pre-specified|Percutaneous Coronary Intervention (PCI)|Number of participants that experienced percutaneous coronary intervention (PCI)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294272|NCT00092677|Other Pre-specified|Coronary Artery Bypass Grafting (CABG)|Number of participants that experienced coronary artery bypass grafting (CABG)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294273|NCT00092677|Other Pre-specified|Nonfatal Myocardial Infarction (MI)|Number of participants that experienced nonfatal myocardial infarction (MI)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294274|NCT00092677|Other Pre-specified|Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS)|Number of participants that experienced Congestive Heart Failure (CHF) due to progression of aortic stenosis (AS)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294275|NCT00092677|Other Pre-specified|Aortic Valve Replacement (AVR)|Number of participants that experienced aortic valve replacement (AVR)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294276|NCT00092677|Other Pre-specified|Cardiovascular Death|Number of participants that experienced cardiovascular death|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294277|NCT00092677|Secondary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)|Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294278|NCT00092677|Secondary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)|Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294279|NCT00092677|Primary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)|Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
1294448|NCT00090857|Secondary|Worst Grade Hot Flashes|Participants reported worst grade hot flashes: 01: mild (<1qd) or 02: moderate (>1qd) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.|||Participants|||Count of Participants
1294281|NCT00092547|Secondary|Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females|The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.|Up to Month 126|Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.|||Cases per 100 person-years at risk||95% Confidence Interval|Number
1294282|NCT00092547|Secondary|Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)||Month 37 (1 Month Post-dose 3 of qHPV)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations within appropriate day ranges, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294283|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)||Month 37 (31 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294284|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)||Month 30 (24 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294285|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)||Month 24 (18 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294286|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)||Month 18 (Month 12 Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294287|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)||Month 7 (1 Month Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294288|NCT00092547|Secondary|Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 37 (1 Month Post-dose 3 of qHPV)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294289|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 37 (31 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294290|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 30 (24 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294291|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 24 (18 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294292|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 18 (12 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294293|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 7 (1 Month Postdose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294294|NCT00092547|Primary|Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up|"A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported."|Month 37 to Month 126|The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up.|||Participants|||Number
1294295|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294296|NCT00092547|Primary|Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126||Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294297|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294298|NCT00092547|Primary|Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96||Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294299|NCT00092547|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72||Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
1294300|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
1294301|NCT00092547|Primary|Number of Participants Reporting Other (Non-serious) AEs Through Month 18|Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18|Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.|||participants|||Number
1294302|NCT00092547|Primary|Number of Participants Reporting SAEs From Month 18 Through Month 37|Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37|Month 18 to Month 37|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.|||participants|||Number
1294303|NCT00092547|Primary|Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18|"Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment."|Up to Month 18|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.|||participants|||Number
1294304|NCT00092534|Secondary|Subjects With Anti-HPV 18 Titer >/= 24 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 24 mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.|||Participants|||Number
1294305|NCT00092534|Secondary|Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.|||Participants|||Number
1294306|NCT00092534|Secondary|Subjects With Anti-HPV 11 Titer >/= 16 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 16 mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.|||Participants|||Number
1294307|NCT00092534|Secondary|Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20 mMU/mL|Week 4 Postdose 3 (4 weeks after 3rd vaccine dose)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.|||Participants|||Number
1294308|NCT00092534|Primary|Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type|"Tolerability = Number of subjected affected. Incidence Rate per person-years of follow-up.~The tolerability objective was to demonstrate that Gardasil is generally well tolerated by females aged 16-23. The relevant data are presented in the Reported Adverse Events section. No formal statistical hypothesis testing were performed for this objective."|Follow-up through end of study (4 years)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase chain reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data.|||Incidence per 100 person-years|||Number
1294309|NCT00092521|Primary|Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]||Follow-up through end of study (4 years)|"Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data.~Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."|||incidence rate per 100 person-years|||Number
1294310|NCT00092521|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer||Follow-up through end of study (4 years)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase Chain Reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population.|||incidence rate per 100 person-years|||Number
1294311|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294312|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||Subjects|||Number
1294313|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294314|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||Subjects|||Number
1294315|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294316|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||Subjects|||Number
1294317|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294318|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3|Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL|||Number
1294319|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294320|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||Subjects|||Number
1294321|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294322|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||Subjects|||Number
1294323|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294324|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||Subjects|||Number
1294325|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294326|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||Subjects|||Number
1294327|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)|Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
1294328|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)|SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
1294329|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)|CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
1294330|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Clinical Adverse Experiences|A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
1294331|NCT00092456|Other Pre-specified|Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)|Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
1294332|NCT00092456|Other Pre-specified|Number of Subjects With Vaccine-Related Clinical AEs (CAEs)|CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
1294333|NCT00092456|Other Pre-specified|Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)|Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
1294334|NCT00092456|Other Pre-specified|Number of Subjects With Clinical Adverse Experiences (CAEs)|Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|Safety Population: All subjects who were vaccinated and followed up|||Participants|||Number
1294335|NCT00092456|Other Pre-specified|Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).|Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA|42 days following the 3rd vaccination|Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.|||units/mL||95% Confidence Interval|Geometric Mean
1294336|NCT00092456|Primary|Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]|Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]|42 days following the 3rd vaccination|Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.|||dilution units||95% Confidence Interval|Geometric Mean
1294337|NCT00092443|Secondary|Number of Subjects With ≥3 Fold Rise in Antibody Titer|Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)|14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen EIA prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.|||Participants|||Number
1294338|NCT00092443|Primary|Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.|G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen Enzyme immunoassay (EIA) prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.|||Participants|||Number
1294339|NCT00092417|Other Pre-specified|Number of Participants With Fevers ≥101.0°F [≥38.3°C]|Maximum reported oral or equivalent temperature ≥101.0°F [≥38.3°C] was reported Day 1 through Day 21 postvaccination.|Day 1-21 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. 5 participants in the Zoster Vaccine Higher Potency group and 3 participants in the Zoster Vaccine Lower Potency group were not included in this analysis since these participants were without a follow-up.|||Participants|||Number
1294340|NCT00092417|Other Pre-specified|Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes|Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR).|Day 1-42 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.|||Participants|||Number
1294341|NCT00092417|Other Pre-specified|Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions|Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR).|Day 1-42 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.|||Participants|||Number
1294342|NCT00092417|Primary|Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)||Day 1-5 postvaccination|The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.|||Participants|||Number
1294343|NCT00092417|Primary|Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)|The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.|Day 1-42 post vaccination|The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.|||Participants|||Number
1294344|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1294345|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1294346|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1294347|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
1294348|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
1294349|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
1294350|NCT00092131|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
1294351|NCT00092131|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
1294352|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
1294353|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose||0-90 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
1294354|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
1294355|NCT00092131|Primary|Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In Participants with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
1294374|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Osteocalcin|Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294356|NCT00092118|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period|Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.|Baseline and Week 6|The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available|||Score on a scale||95% Confidence Interval|Least Squares Mean
1294357|NCT00092118|Secondary|Patient’s Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.|At the end of the 6 week treatment period|The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1294358|NCT00092118|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis|Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].|6 week treatment period (from baseline though the end of week 6)|The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1294359|NCT00091962|Secondary|Disease-Specific Health-Related Quality of Life|The 12-item Duke Activity Status Index (DASI). Scores range from 0-58.2, and higher scores the better the functional capacity (Am J Cardiol. 1989;64(10):651-654).|8 months post CABG||||units on a scale||Standard Error|Mean
1294360|NCT00091962|Secondary|Generic Physical Health-Related Quality of Life|"The 36-item Medical Outcomes Study Form (v.2) Physical Component Scale (SF-36 PCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.~Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User’s Manual. 2nd ed. Boston, MA: New England Medical Center; 1994."|8 months post CABG||||participants||Standard Error|Mean
1294361|NCT00091962|Secondary|Hamilton Rating Scale for Depression|The 17-item Depression Interview and Structured Hamilton (DISH) version of the Hamilton Rating Scale for Depression Standard provides an accurate DSM-IV diagnosis of a cardiac patient’s mood disorder and a reliable HRS-D score. Range 0-52. Higher scores are worse. Psychosom Med. 2002;64(6):897-905|8 months post CABG||||units on a scale||Standard Error|Mean
1294362|NCT00091962|Primary|Generic Mental Health-Related Quality of Life|"The 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.~Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User’s Manual. 2nd ed. Boston, MA: New England Medical Center; 1994."|Measured 8 months post-CABG||||units on a scale||Standard Error|Mean
1294363|NCT00091949|Secondary|Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure||5 years||||participants|||Number
1294364|NCT00091949|Secondary|Decline in Cognitive Status|Change in modified mental status examination (3MS) score from baseline to exit. Theoretical range of 3MS scores is 0-100. Baseline scores ranged from 22-100.|Annual measures from baseline to exit (up to 5 years)|Participants with baseline and at least 1 follow-up modified mini-mental examination score.|||units on a scale||Standard Error|Mean
1294365|NCT00091949|Secondary|All Cause Mortality||5 years||||participants|||Number
1294366|NCT00091949|Secondary|Development of Overt Diabetes||5 years||||participants|||Number
1294367|NCT00091949|Secondary|Acute Coronary Syndrome|Fatal or non-fatal acute myocardial infarction or unstable angina|5 years||||participants|||Number
1294368|NCT00091949|Secondary|Fatal or Non-fatal Stroke Alone||5 years||||participants|||Number
1294369|NCT00091949|Primary|Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction||Up to 5 years||||participants|||Number
1294370|NCT00091832|Secondary|Number of Participants With Hypercalcemia|Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.|Day 1 to Week 57|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Participants|||Number
1294371|NCT00091832|Secondary|Number of Participants With Skeletal Related Events|Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|From Day 1 to Week 25|All participants who were exposed to investigational product.|||Participants|||Number
1294372|NCT00091832|Secondary|Time to First Skeletal Related Event|Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1 to Week 25|All participants who were exposed to investigational product.|||Days||95% Confidence Interval|Median
1294373|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Osteocalcin|Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294406|NCT00091507|Primary|Progression of Acute Coronary Syndrome to Myocardial Infarction|Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.|24 hours||||participants|||Number
1294375|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)|Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294376|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)|Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294377|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)|Percent change from Baseline to Week 25 in TRAP5b calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294378|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)|Percent change from Baseline to Week 13 in tartrate-resistant acid phosphatase 5b calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294379|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in P1NP|Percent change from Baseline to Week 25 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Week 25 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294380|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)|Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294381|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)|Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294382|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)|Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294383|NCT00091832|Secondary|Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline|Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.|Baseline to Week 57|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Days||Inter-Quartile Range|Median
1294384|NCT00091832|Secondary|Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25|The number of participants achieving a 65% reduction or more in uNTX from Baseline at Week 25. Calculation used is ((Week 25 value - Baseline value) / Baseline value) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Participants|||Number
1294385|NCT00091832|Secondary|Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13|The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. Calculation used is ((Week 13 value - Baseline value) / Baseline value ) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a Baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Participants|||Number
1294449|NCT00090857|Primary|Change in Hip Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of hip density.|||g/cm^2||Full Range|Median
1294386|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)|Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294387|NCT00091832|Primary|Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)|Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
1294388|NCT00091819|Primary|Clinical Response|The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.|7-14 days following end of antibiotic treatment|Data for the all-treated (AT) population are presented. the AT and clinically evaluable (CE) populations were considered co-primary.|||participants|||Number
1294389|NCT00091793|Secondary|Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294390|NCT00091793|Secondary|Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294391|NCT00091793|Secondary|Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294392|NCT00091793|Secondary|Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294393|NCT00091793|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294394|NCT00091793|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294395|NCT00091793|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294396|NCT00091793|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294397|NCT00091793|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months|Randomized subjects who have a non-missing baseline and at least 1 non-missing postbaseline evaluation at or prior to month 24. LOCF was used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294398|NCT00091572|Secondary|Duration of Objective Response|Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.|Treatment continued until disease progression or unacceptable toxicity.|All responders|||Months||95% Confidence Interval|Median
1294399|NCT00091572|Secondary|Objective Response Rate in Subjects With Measurable Lesions|Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.|Treatment continued until disease progression or unacceptable toxicity.|Intent to treat population with measurable disease at Baseline.|||Ratio||95% Confidence Interval|Median
1294400|NCT00091572|Primary|Overall Survival|Overall Survival was defined as the time from the date of randomization to the date of death from any cause.|The final analysis was to be performed when at least 616 deaths had occurred.|Intent to Treat Population|||Months||95% Confidence Interval|Median
1294401|NCT00091572|Secondary|Progression Free Survival|Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.|Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.|Intent to Treat Population|||Months||95% Confidence Interval|Median
1294402|NCT00091507|Secondary|Cardiac Arrest or Acute Mortality|Outcome for all participants (composite of cardiac arrest or acute mortality)|Prehospital setting through hospitalization||||participants|||Number
1294403|NCT00091507|Secondary|Mortality|Outcome for all participants (mortality at 30 days).|30 days|30 day mortality.|||participants|||Number
1294404|NCT00091507|Secondary|Heart Failure or Death|Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)|30 days||||participants|||Number
1294405|NCT00091507|Secondary|Cardiac Arrest|Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization.|1 to 18 hours (From prehospital setting through hospitalization.)||||participants|||Number
1294407|NCT00091442|Primary|Time to Progression|Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.|From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled|Intent to Treat: For patients who were progression free at the time of data cutoff, data were censored for time to progression at the time of their last tumor assessment.|||Months||95% Confidence Interval|Median
1294408|NCT00091442|Secondary|Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)|Number of participants in the evaluable population who achieved a CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: Disappearance of all target lesions and PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Response was assessed by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI).|Up to 30 to 42 days after last dose of study medication|Evaluable population: Included all randomized participants who received at least 1 dose of study medication (DOXIL or docetaxel), and who had at least 1 postbaseline tumor assessment.|||Participants|||Number
1294409|NCT00091442|Secondary|Overall Survival|Time interval in months between the date of randomization and the participant's death from any cause.|From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled|Intent to Treat: If the date of death was unknown, the data were censored at the date that the participant was last known to have been alive.|||Months||95% Confidence Interval|Median
1294410|NCT00091390|Secondary|Clinical Progression Including Local/Regional and Distant Relapse||From registration to the date of local/regional progression or distant relapse, or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.|||||||
1294411|NCT00091390|Secondary|Disease-specific Survival||From registration to the date of death due to prostate cancer or other disease related cause. Analysis occurs after each patient has had 3 years of follow-up.|||||||
1294412|NCT00091390|Secondary|Overall Survival||From registration to the date of death or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.|||||||
1294413|NCT00091390|Secondary|Biochemical Failure||From registration to the date of biochemical failure or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.|||||||
1294414|NCT00091390|Secondary|Acute Severe GU and GI Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Within 9 Months of Starting Treatment||From registration until 9 months from the start of treatment|||||||
1294415|NCT00091390|Primary|Late Severe Genitourinary (GU) and Gastrointestinal (GI) Toxicity at 18 Months|Eighteen-month rate of late severe (grade 3-5) genitourinary (GU) and gastrointestinal (GI) toxicity, defined as starting more than 9 months from treatment start, and graded by CTCAE v3.0|Beginning nine months after start of treatment.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1294416|NCT00091273|Secondary|Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay||Days 1,8,15,22,29,36,43,50 and Month 3|All treated subjects were assessed.|||participants|||Number
1294417|NCT00091273|Primary|Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay||Day 22|All treated subjects were assessed.|||participants|||Number
1294418|NCT00091273|Primary|Safety of the Vaccine|Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.|Days 1,8,15,22,29,36,43,50|All treated subjects were assessed.|||participants|||Number
1294419|NCT00091260|Secondary|Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response||1 year||||participants|||Number
1294420|NCT00091260|Primary|Number of Patients With Hematologic Response With Single-agent CC-5013|"Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.~Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.~For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.~For patients with an elevated serum free light chain assay, a reduction of 50% or more."|3 months|Participants who received at least 3 cycles of single-agent CC-5013 and underwent subsequent evaluation.|||Participants|||Count of Participants
1294421|NCT00091260|Primary|Number of Patients Removed From Study Treatment Due to Toxicities||1 year|Number of patients who had at least one dose of CC-5013|||participants|||Number
1294422|NCT00091169|Secondary|Proportion of Patients With Stable or Improving Performance Status at 4 Weeks|Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS.|assessed at baseline and 4 weeks after randomization|All randomized patients who had performance status data at baseline and 4 weeks|||proportion of participants||95% Confidence Interval|Number
1294423|NCT00091169|Secondary|Prevalence of Carnitine Deficiency at 4 Weeks|Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine > 0.4 μmol/L or free carnitine < 35 μmol/L for males and < 25 μmol/L for females.|assessed at 4 weeks after randomization|All randomized patients who had carnitine data at 4 weeks|||proportion of participants||95% Confidence Interval|Number
1294424|NCT00091169|Secondary|Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks|Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported BPI score at both baseline and 4 weeks|||units on a scale||95% Confidence Interval|Mean
1294425|NCT00091169|Secondary|Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline|Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported CES-D score at both baseline and 4 weeks|||units on a scale||95% Confidence Interval|Mean
1294426|NCT00091169|Secondary|Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks|Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported FACIT-F score at both baseline and 4 weeks|||units on a scale||95% Confidence Interval|Mean
1294427|NCT00091169|Primary|Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks|Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients|||units on a scale||95% Confidence Interval|Mean
1294428|NCT00091026|Secondary|Overall Survival|Time from randomization until death from any cause. Analyzed using the Kaplan-Meier (1958) estimator and their associated 5% confidence intervals determined using the method described in Brookmeyer and Crowley.|36 months||||Months||95% Confidence Interval|Median
1294429|NCT00091026|Secondary|Progression-free Survival|Median progression-free survival time (time from randomization to disease progression or death from any cause). Analyzed using the Kaplan-Meier (1958) estimator and their associated 95% confidence intervals determined using the method described in Brookmeyer and Crowley.|36 months||||months||95% Confidence Interval|Median
1294430|NCT00091026|Primary|Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)||Up to 6 months||||percentage of participants||95% Confidence Interval|Number
1294431|NCT00090987|Secondary|Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus||12 months|||||||
1294432|NCT00090987|Secondary|Mechanisms of Primary and Secondary Resistance to Imatinib Therapy|Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression|12 months|||||||
1294433|NCT00090987|Secondary|Pharmacokinetic Profile of Imatinib and Antiretrovirals||12 months|||||||
1294434|NCT00090987|Secondary|Cytokine Profiles Before and After Imatinib Therapy||12 months|||||||
1294435|NCT00090987|Secondary|Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry||12 months|||||||
1294436|NCT00090987|Primary|Proportion of Patients Who Achieve a Clinical Response|Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for >4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions|20-24 weeks||||proportion|||Number
1294437|NCT00090870|Secondary|Progression-free Survival||From registration until diease progression or death, whichever comes first.|Data for this endpoint was not collected||||||
1294438|NCT00090870|Secondary|Frequency of Adverse Events Assessed by NCI CTC Version 2||From the first day of treatment until the end of treatment visit, an average of 6 months|Data for this endpoint was not collected||||||
1294439|NCT00090870|Secondary|Duration of Response||time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.|Data for this endpoint was not collected||||||
1294440|NCT00090870|Primary|Response Rate|To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide|while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year|Data for this endpoint was not collected||||||
1294441|NCT00090857|Secondary|Worst Grade Fatigue|Participants reported worst grade fatigue: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.||||Participants|||Count of Participants
1294442|NCT00090857|Secondary|Worst Grade Headache|Participants reported worst grade headache: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.||||Participants|||Count of Participants
1294443|NCT00090857|Secondary|Worst Grade Bone Pain|Participants reported worst grade bone pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.||||Participants|||Count of Participants
1294444|NCT00090857|Secondary|Worst Grade Abdominal Pain|Participants reported worst grade abdominal pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.|||Participants|||Count of Participants
1294445|NCT00090857|Secondary|Worst Grade Vomiting|Participants reported worst grade vomiting grade 01: 1x in 24 hours, 02: 2-5x in 24 hours, 03: >/= 6x in 24 hours, grade 04: requiring parenteral nutrition/intensive care during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.|||Participants|||Count of Participants
1295788|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1294450|NCT00090857|Primary|Change in Trochanter Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of trochanter density.|||g/cm^2||Full Range|Median
1294451|NCT00090857|Primary|Change in Femoral Neck Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of femoral neck density.|||g/cm^2||Full Range|Median
1294452|NCT00090857|Primary|Change in Lumbar Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of lumbar density.|||g/cm^2||Full Range|Median
1294453|NCT00090844|Secondary|Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|Every 6 months for 2 years then annual for 3 more years. Patients will be seen, laboratory specimens will be drawn. Menses records will be collected and reviewed. Concomitant medications will be updated.|5 years after end of chemotherapy|||||||
1294454|NCT00090844|Secondary|Quality of Life as Assessed by FACT-ES Monthly During Treatment, Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|FACT-ES (v4/4a) quality of life validated tool combines 18 item endocrine subscale (ES) with standardized breast cancer quality of life measure. Administered monthly during treatment, every very 6 months beginning in month 6 for 2 years and then annually for 3 years.|Baseline, through chemotherapy then 5 years|||||||
1294455|NCT00090844|Secondary|Alternative Markers of Ovarian Failure as Assessed by Inhibin A and Inhibin B Every 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|Inhibin A & inhibin B are collected at baseline, end of chemotherapy, then every 6 months for 2 years then annually for 3 more years. Inhibin A & Inhibin B are markers of ovarian failure.|Baseline, end of chemotherapy then 5 years|||||||
1294456|NCT00090844|Secondary|Chemotherapy-related Amenorrhea|Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years.|Baseline, end of chemotherapy then 5 years|||||||
1294457|NCT00090844|Primary|Time to Resumption of Menses|Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years|Baseline, end of chemotherapy then 5 years||||months||Full Range|Median
1294458|NCT00090779|Secondary|Time to Treatment Initiation or Death|5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death|5 years since randomization|All eligible subjects were included except one subject in IT arm with baseline multidrug resistance.|||weeks||95% Confidence Interval|Number
1294459|NCT00090779|Secondary|Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.|96 weeks since randomization|Through database cutoff for DSMB review (by July 2, 2009). The analysis includes only those in the IT arm who continued ART through week 36 (n=49), compared to all in the DT arm (n=64).|||weeks||95% Confidence Interval|Number
1294460|NCT00090779|Secondary|Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.|96 weeks since randomization|Throughout database cutoff for DSMB review (by July 2, 2009).|||weeks||95% Confidence Interval|Number
1294461|NCT00090779|Secondary|Number of Participants in IT Arm Off Treatment Before 36 Weeks|The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm.|At Week 36|All 66 eligible subjects in IT arm were included.|||participants|||Number
1294462|NCT00090779|Secondary|Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis.|96 weeks since randomization|All 130 eligible subjects were included.|||Participants|||Number
1294463|NCT00090779|Secondary|Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm||IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)|One subject in IT arm with multidrug resistance at baseline was excluded from this analysis.|||Change in Log10 transformed CD4 Counts||Standard Deviation|Mean
1294464|NCT00090779|Primary|Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.||96 weeks since randomization||||participants|||Number
1294465|NCT00090779|Primary|Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm|The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the “failures” who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.|IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)|Participants in follow-up at least 72 weeks since randomization were included.|||rank||Full Range|Median
1294466|NCT00090779|Primary|Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm|The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the “failures” who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.|At Weeks 72 and 76|Participants in follow-up at least 72 weeks since randomization were included.|||rank||Full Range|Median
1294467|NCT00090766|Secondary|Number of Participants Who Experienced Episodes of Rejection Over Time|Participants with biopsy proven active rejection are reported.|Up to Week 26|The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.|||participants|||Number
1294468|NCT00090766|Secondary|Mean Elimination Half-Life of Valganciclovir Over Time|The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14|The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken.|||hours||Standard Deviation|Mean
1294469|NCT00090766|Secondary|Mean Maximum Plasma Concentration of Valganciclovir Over Time|Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14|The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.|||mcg/mL||Standard Deviation|Mean
1294470|NCT00090766|Secondary|Number of Participants Who Experienced Graft Loss|Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.|Up to Week 26|ITT population: The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.|||participants|||Number
1294471|NCT00090766|Secondary|Number of Participants With Treatment Failures|Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.|Up to Week 26|The Intent to Treat (ITT) population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.|||participants|||Number
1294472|NCT00090766|Secondary|Number of Participants With Cytomegalovirus Disease Over Time|Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
1294473|NCT00090766|Primary|Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry|The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
1294474|NCT00090766|Primary|Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry|The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
1295095|NCT00085839|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death (maximum 26.8 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.|||months||95% Confidence Interval|Median
1294475|NCT00090766|Primary|Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug|An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
1294476|NCT00090766|Primary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
1294477|NCT00090766|Primary|Number of Participants With Opportunistic Infections|Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
1294478|NCT00090766|Primary|Number of Participants With Adverse Events Leading to Dose Interruption or Modification|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
1294479|NCT00090766|Primary|Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir|Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14|Pharmacokinetic (PK) population comprised of all participants from studies WP16296, WP16303 and WV16726 who had completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.|||mcg*hr/mL||Standard Deviation|Mean
1294480|NCT00090753|Secondary|Percentage of Patients Who Had at Least 1 Adverse Event|See the adverse events section of the results for more information.|From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)|Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.|||Percentage of participants|||Number
1294481|NCT00090753|Primary|Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation|Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.|Baseline to the end of the study (Up to 49 Months)|Analysis includes participants from the Intent-to-treat population (all patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA) who had hemoglobin values available for analysis.|||g/dL||Standard Deviation|Mean
1294482|NCT00090610|Secondary|Median Overall Survival||Every 6 months starting at 12 months, to 24 months||||months||95% Confidence Interval|Median
1294483|NCT00090610|Secondary|Recurrence-Free Survival|Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.|Every 6 months starting at 12 months, to 24 months|Subjects who had a complete response.|||months||95% Confidence Interval|Median
1294484|NCT00090610|Secondary|Quality of Life|"Quality of Life was measured using the Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, version 4. The TOI portion of the FACT-O included questions related to Physical well-being (PWB), Social/Family well-being (FWB), and an ovarian cancer specific module (OCS). The PWB score range is from 0-28; the FWB score range is from 0-28; the OCS score range is from 0-44; this gives the TOI a score range from 0-100. (TOI = PWB + FWB + OCS)~With these instruments, a higher score indicates better health-related quality of life."|Baseline performed 14 days before first dose, then every other cycle and at study termination|The number of participants was based on QoL data available for Arm 1 and one patient withdrew on Arm 2.|||units on a scale||Standard Deviation|Mean
1294485|NCT00090610|Secondary|Objective Response Rate|"Complete response rate plus partial response rate, where: Complete response (CR) is defined as disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart and normalization of elevated CA125 in cases of ovarian cancer; Partial response (PR) for measurable disease is defined >= 30% decrease in the sum of the longest dimensions of all target measurable lesions with no unequivocal progression of non-target lesions as well as no new lesions, with documentation by two disease assessments at least four weeks apart. PR according to CA125 levels is defined as a 50% decrease in CA125 levels where two initial samples were elevated and the sample that shows the 50% is confirmed by a fourth sample 28 days after the prior sample.~OR = CR + PR"|Every 6 months, starting at 12 months to 24 months|Same as for PFS|||percentage of participants||95% Confidence Interval|Number
1294511|NCT00090363|Primary|Time to Progression (TTP)|Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.|Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).||||Days||Inter-Quartile Range|Median
1294486|NCT00090610|Primary|Progression-free Survival (PFS)|"Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression~Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease."|Every 6 months, to 18 months|1 patient in each arm was excluded. The patient in Arm 1 did not complete 1 cycle of therapy. A patient in Arm 2 withdrew from the study|||months||95% Confidence Interval|Median
1294487|NCT00090584|Secondary|Symptom Improvement|"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?"|8 months|Participants who completed the perceived improvement item at 8 months.|||participants|||Number
1294488|NCT00090584|Secondary|Symptom Improvement|"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?"|10 weeks|Participants who completed the satisfaction item at 10 weeks.|||participants|||Number
1294489|NCT00090584|Secondary|Satisfaction|"Number of women who responded completely satisfied to question How satisfied are you with your progress?"|8 months|Number of participants who completed the 8 months satisfaction questions|||participants|||Number
1294490|NCT00090584|Secondary|Satisfaction|"Number of women who responded completely satisfied to question, How satisfied are you with your progress?"|10 weeks|Number of women who completed satisfaction question at 10 weeks.|||participants|||Number
1294491|NCT00090584|Secondary|Symptom Bother|Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.|baseline, 10 weeks and 8 months|Participants who completed OAB-q assessment at each time in each treatment group.|||units on a scale||Standard Deviation|Mean
1294492|NCT00090584|Secondary|Symptom Distress|Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.|baseline, 10 weeks and 8 months|All women who completed UDI at each time in each treatment group|||units on a scale||Standard Deviation|Mean
1294493|NCT00090584|Secondary|Change in Voids Per Day|Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary|baseline and 10 weeks|All women with valid bladder diary at baseline and 10 weeks in each treatment group.|||voids per day||Standard Error|Mean
1294494|NCT00090584|Secondary|Change in Incontinence Episodes|Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.|Baseline and 10 weeks|All women with valid bladder diary at baseline and 10 weeks in each treatment group.|||incontinence episodes per week||Standard Error|Mean
1294495|NCT00090584|Primary|Proportion of Women Who Meet Definition of Success|Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline.|8 months|All women who completed the 8 months assessment or were known to return to drug use prior to that time.|||participants|||Number
1294496|NCT00090519|Primary|Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye|The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.|Baseline, 36 Months|Intent-to-treat (ITT) population: all randomized participants with at least 1 eligible study eye analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||participants|||Number
1294497|NCT00090519|Secondary|Number of Participants With Adverse Events|Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.|Baseline through 36 Months|Safety population: all randomized participants who received at least one dose of study drug.|||participants|||Number
1294498|NCT00090519|Secondary|Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months|25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning.|36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||units on a scale||Standard Deviation|Mean
1294499|NCT00090519|Secondary|Change From Baseline at Endpoint in Albumin/Creatinine Ratio||36 Months|The completer population includes participants who completed all 36 months of the treatment phase.|||micrograms/millimole (ug/mmol)||Standard Deviation|Mean
1294500|NCT00090519|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate|The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration [mg/deciliter (dL)])-0.999 X (Age [years]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration [mg/dL])-0.170 X (Serum albumin concentration [grams (g)/dL])+0.318.|Baseline, 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||milliliter/minute/1.73 square meter||Standard Deviation|Mean
1294501|NCT00090519|Secondary|Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography|Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale.|Baseline through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||participants|||Number
1294502|NCT00090519|Secondary|Change From Baseline in Contrast Sensitivity by Pelli-Robson|Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes.|Baseline, 36 Months|Intent-to-treat (ITT) population: all randomized participants analyzed according to treatment group to which they were originally assigned by random allocation even if they did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.|||Letters read correctly|Participants|Standard Deviation|Mean
1294503|NCT00090519|Secondary|First Occurrence of Focal/Grid Photocoagulation|The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.|Baseline through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||participants|||Number
1294504|NCT00090519|Secondary|Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months|ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes.|Baseline, 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Letters read correctly|Participants|Standard Deviation|Mean
1294505|NCT00090519|Primary|Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)|Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.|6 Months through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||months per participant||Standard Deviation|Mean
1294506|NCT00090493|Primary|The Number of Participants Experiencing a Response to the Peptide Vaccines.|The peptides are fragments from two proteins MAGE-A3 and NY-ESO-1. There will be a series of 12 peptide vaccinations given as a subcutaneous (beneath the skin) injection (vaccines) at 2 week intervals resulting in an immune response to myeloma. The tumor peptides used in the vaccines are unique to myeloma, and it is not expected that there will be an immune response to normal organs. Myeloma cells must express MAGE-A3 or NY-ESO-1, be severe enough to require chemotherapy and stem cell transplantation and have appropriate HLA tissue type.|2 week intervals|only 2 were complete per protocol. 2 were withdrawn by physician due to relapse.|||participants|||Number
1294507|NCT00090363|Secondary|Change in Number of Bone Metastases Over Time|Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.|Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.||||Percentage Change||Standard Deviation|Mean
1294508|NCT00090363|Secondary|Objective Response Rate (ORR)|Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.|For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).|Only patients with measurable disease at the baseline were included in the analysis.|||percentage of participants|||Number
1294509|NCT00090363|Secondary|Change in Total Prostate Specific Antigen (PSA) Over Time|Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.|Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).|The analysis population only includes patients with baseline and Week 12 PSA measurements|||Percentage Change in PSA||Standard Deviation|Mean
1294510|NCT00090363|Secondary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method.|Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).||||Days||Inter-Quartile Range|Median
1294515|NCT00090545|Secondary|Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)|Overall response was evaluated by the RECIST. Complete Response (CR) is the disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Every 2 cycles (1 cycle = 28 days)|For stage 1, not all patients were analyzed for RECIST. Some patients came off study for rising prostatic specific antigen (PSA) only.|||Participants|||Count of Participants
1294516|NCT00090545|Secondary|Median Overall Survival|Time from treatment start date until date of death or date last known alive.|Time from treatment start date until date of death or date last known alive, approximately 18.3 months.||||Months||95% Confidence Interval|Median
1294517|NCT00090545|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 49 months.||||Participants|||Count of Participants
1294518|NCT00090545|Primary|Progression Free Survival|Determine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria.|4 months||||months||95% Confidence Interval|Median
1294519|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA|Antibodies to HPV types were measured using IgG LIA. Thresholds for seropositive were ≥9, 6, 5, and 5 IgG LIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 120|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study..|||Percentage of participants||95% Confidence Interval|Number
1294520|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)|Antibodies to HPV types were measured using Luminex immunoassay (IgG-LIA). The unit of measure for this assay is IgG LIA mMU/mL; this unit cannot be directly compared with the cLIA mMU/mL unit reported for the cLIA results.|Month 120|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||IgG LIA mMU/mL||95% Confidence Interval|Geometric Mean
1294521|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 120|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||Percentage of participants||95% Confidence Interval|Number
1294522|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 72|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||Percentage of participants||95% Confidence Interval|Number
1294523|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 36|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||Percentage of participants||95% Confidence Interval|Number
1294524|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 7|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||Percentage of participants||95% Confidence Interval|Number
1294525|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).|Month 120|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||cLIA mMU/mL||95% Confidence Interval|Geometric Mean
1294526|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).|Month 72|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||cLIA mMU/mL||95% Confidence Interval|Geometric Mean
1294527|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).|Month 36|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||cLIA mMU/mL||95% Confidence Interval|Geometric Mean
1294528|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)|Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).|Month 7|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||cLIA mMU/mL||95% Confidence Interval|Geometric Mean
1294529|NCT00090285|Secondary|Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection|Participants with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up was assessed.|Base study: through Month 36|Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.|||Detection per 100 person-years|||Number
1294530|NCT00090285|Secondary|Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection|Participants with HPV Type 6/11/16/18-related persistent infection per 100 person-years of follow-up was assessed.|Base study: through Month 36|Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.|||Infection per 100 person-years|||Number
1294531|NCT00090285|Other Pre-specified|Base Study: Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM)|Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up was assessed.|Base study: through Month 36|Only a subset of participants was included for this sub-study. Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.|||Incidence per 100 person-years|||Number
1294532|NCT00090285|Primary|LTFU (EXT2): Number of Participants Who Died|The number of participants who died was assessed.|LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine|The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).|||Participants|||Count of Participants
1294533|NCT00090285|Primary|LTFU (EXT2): Number of Participants With Vaccine-Related SAEs|An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.|LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine|The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).|||Participants|||Count of Participants
1294534|NCT00090285|Primary|Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)|A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.|Base study: through Month 36|The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.|||Participants|||Count of Participants
1294535|NCT00090285|Primary|Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.|Base study: through Day 5 after any vaccination|The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.|||Participants|||Count of Participants
1294536|NCT00090285|Primary|Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer|Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.|Up to 10 years after the first dose of qHPV vaccine|Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to MSM in the Base Study qHPV vaccine group.|||Incidence per 10,000 person-years||95% Confidence Interval|Number
1294551|NCT00090233|Primary|Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination|Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.|At least 14 days following the 3rd vaccination through the first full rotavirus season|Per Protocol Population Using Per-Protocol Case Definition|||Participants|||Number
1294537|NCT00090285|Primary|Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer|Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.|Up to 10 years after the first dose of qHPV vaccine|Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.|||Incidence per 10,000 person-years||95% Confidence Interval|Number
1294538|NCT00090285|Primary|Overall Study: Incidence of HPV Type 6/11-related Genital Warts|Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.|Up to 10 years after the first dose of qHPV vaccine|Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.|||Incidence per 10,000 person-years||95% Confidence Interval|Number
1294539|NCT00090285|Primary|Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer|Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.|Base study: through Month 36|Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.|||Incidence per 100 person-years|||Number
1294540|NCT00090259|Secondary|Number of Participants That Experienced Cardiovascular Hospitalization||Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
1294541|NCT00090259|Secondary|Number of Participants That Were Hospitalized for Heart Failure||Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
1294542|NCT00090259|Secondary|Number of Participants That Died (Any Cause)||Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
1294543|NCT00090259|Secondary|Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization|Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.|Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
1294544|NCT00090259|Primary|Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure||Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
1294545|NCT00090233|Secondary|Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F|Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.|42 days following third dose|Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.|||micrograms/mL||95% Confidence Interval|Geometric Mean
1294546|NCT00090233|Secondary|Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin|Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).|42 days following third dose|Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.|||ELISA units/mL||95% Confidence Interval|Geometric Mean
1294547|NCT00090233|Secondary|Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo|The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, & polio types 1, 2, & 3, per established criteria.|42 days following third dose|Per Protocol Population|||Participants|||Number
1294548|NCT00090233|Secondary|Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose|Number of participants with rotavirus gastroenteritis whose clinical score was >16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].|At least 14 days following the 3rd vaccination through the first rotavirus season|Per Protocol Population Using Per-Protocol Case Definition|||Participants|||Number
1294549|NCT00090233|Secondary|Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.|Number of participants with rotavirus gastroenteritis whose clinical score was >8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].|At least 14 days following the 3rd vaccination through the first rotavirus season|Per Protocol Population Using Per-Protocol Case Definition|||Participants|||Number
1294550|NCT00090233|Secondary|Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4|Health Outcomes Substudy – Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.|At least 14 days following the 3rd vaccination|Per Protocol Population Using Per-Protocol Case Definition|||Annual # of events per 1000 person-years|||Number
1294552|NCT00090233|Secondary|G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus|Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.|14 days following the 3rd vaccination|Per Protocol Population among participants in Finland using Per-Protocol Case Definition|||Participants|||Number
1294553|NCT00090233|Primary|Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo|Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.|Within 42 days following any dose of RotaTeq™/placebo|All participants in the study were followed for potential cases of intussusception.|||Participants|||Number
1294554|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10|The four HPV types were determined by PCR testing.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294555|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294556|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294557|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294558|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294559|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294560|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7|||Incidence per 100 person-years|||Number
1294561|NCT00090220|Secondary|Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|||||||
1294562|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294637|NCT00090103|Secondary|The Number of Participants With Each of the Five Components of BPH Clinical Progression|The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.|Baseline (Day 1) to Year 4|ITT Population|||participants|||Number
1294563|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294564|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294565|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294566|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294567|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.|Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294568|NCT00090220|Secondary|Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7|||Incidence per 100 person-years|||Number
1294569|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
1294570|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
1294571|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
1294713|NCT00089661|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|Subjects with non-missing baseline and >= 1 non-missing post-baseline evaluation. Using Last Observation Carried Forward as imputation.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294572|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
1294573|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
1294574|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
1294575|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
1294576|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
1294577|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294578|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294579|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294714|NCT00089648|Secondary|Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)|Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were to have been analyzed by ELISA analysis; however, no data were collected.|1 year||||pg/mL||Full Range|Mean
1294580|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294581|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294582|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294583|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294584|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
1294585|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10|The four HPV types were determined by PCR testing.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294586|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294587|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Incidence per 100 person-years||95% Confidence Interval|Number
1294588|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294638|NCT00090103|Primary|Number of Participants With AUR or BPH-related Surgery|A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.|Baseline (Day 1) through Year 4|ITT Population|||participants|||Number
1294589|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294590|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Cumulative Incidence Probability||95% Confidence Interval|Number
1294591|NCT00090220|Primary|Number of Participants With an SAE Resulting in Death After Vaccine Administration|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose.|qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120|Participants who received >=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up|||Participants|||Number
1294592|NCT00090220|Primary|Number of Participants With Vaccine-Related SAEs After Vaccine Administration|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.|qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120|Participants who received >=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up|||Participants|||Number
1294593|NCT00090220|Primary|Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received >=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up|||Participants|||Number
1294594|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.|Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7|||Incidence per 100 person-years|||Number
1294595|NCT00090402|Secondary|Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months|The Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) measures an individual's ability to carry out tasks that are important for daily living and capture functional changes. Scores for each question range from 0 (no assistance needed) to 2 (full assistance needed), and were assessed by informant interview. The combination of scores for ADL (ranging from 0-18) and IADL (0-14) is the outcome (0-32), with higher scores indicating lesser ability to carry out daily living tasks.|baseline, 12 months|In the placebo group there were 2 discontinuations (1 moved, 1 death). In the fish oil group there were 2 discontinuations (1 discontinue, 1 death). In the fish oil and lipoic acid group there was 1 discontinuation (due to meds). These discontinuations did not complete the study.|||units on a scale||Standard Error|Mean
1294596|NCT00090402|Primary|Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months|The MMSE is a measure of global cognitive function, and scores range from 0–30, with a lower score indicates greater cognitive impairment.|baseline, 12 months||||units on a scale||Standard Deviation|Mean
1294597|NCT00090402|Primary|F2-isoprostane Level Urine F2-Isoprostanes|F2-isoprostane is a biomarker was used as an effective indicator for detecting a decrease in systemic oxidative damage (oxidative damage in lipids). Urine F2-Isoprostanes were used to avoid ex vivo lipid peroxidation that can occur with plasma samples.|baseline, 12 months|intention to treat (ITT)|||nanogram per miligram||Standard Deviation|Mean
1294715|NCT00089648|Secondary|Plasma Concentration of VEGF-C|Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28)|ITT|||pg/mL||Full Range|Mean
1294598|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1294599|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1294600|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
1294601|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis was an MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
1294602|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
1294603|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
1294604|NCT00090142|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
1294605|NCT00090142|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
1294606|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
1294607|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose||0-90 minutes after the exercise challenge performed at 12 hours postdose|"The secondary efficacy analysis used a modified~intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis."|||Participants|||Number
1294608|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|"The secondary efficacy analysis used a modified~intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis."|||Participants|||Number
1294609|NCT00090142|Primary|Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
1294610|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Would you ask your doctor for the medication you received in this study?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294611|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Overall, how satisfied are you with the study medication and it's effect on your urinary problems?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294612|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294613|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294614|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain during urination?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294615|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain during urination changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294616|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain prior to urinating?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294617|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain prior to urinating changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294618|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on the strength of your urinary stream?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294619|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the strength of your urinary stream changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294620|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on control of your urinary problems? Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294621|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has control of your urinary problems changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
1294622|NCT00090103|Secondary|Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48|The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = [(post-baseline – baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.|Baseline and Months 12, 24, 36, 48|ITT Population. As the study progressed, participants dropped out of the study.|||points on a scale||Standard Error|Least Squares Mean
1294623|NCT00090103|Secondary|Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48|The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study.|||points on a scale||Standard Error|Least Squares Mean
1294624|NCT00090103|Secondary|Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out the study.|||visits|||Number
1294625|NCT00090103|Secondary|Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out of the study.|||visits|||Number
1294626|NCT00090103|Secondary|"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was “yes,” the number of Yes responses was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out of study.|||yes responses|||Number
1294627|NCT00090103|Secondary|Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.|||visits|||Number
1294628|NCT00090103|Secondary|"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?."|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?. If the answer to the question was “yes,” the number of Yes responses was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.|||yes responses|||Number
1294629|NCT00090103|Secondary|Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit? If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.|||visits|||Number
1294630|NCT00090103|Secondary|Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48|Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Transition zone measurements were only done on a subset of participants at sites with experience in measuring the transition zone of the prostate. Also, transition zone measurements were either not performed or missing for some participants at various timepoints.|||percent change||Standard Error|Least Squares Mean
1294631|NCT00090103|Secondary|Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48|Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Also, prostate measurements were either not performed or missing for some participants at various timepoints.|||percent change||Standard Error|Least Squares Mean
1294632|NCT00090103|Secondary|Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48|Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Also, assessments with voided volumes <125 ml were not included in the analysis.|||milliliters (mL)/second (sec)||Standard Error|Least Squares Mean
1294633|NCT00090103|Secondary|Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48|The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study.|||points on a scale||Standard Error|Least Squares Mean
1294634|NCT00090103|Secondary|Number of Participants With an Event of Post-baseline BPH-related Hematospermia|A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.|Baseline (Day 1) through Year 4|ITT Population|||participants|||Number
1294635|NCT00090103|Secondary|Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria|A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.|Baseline (Day 1) through Year 4|ITT Population|||participants|||Number
1294636|NCT00090103|Secondary|Number of Events of Symptom Deterioration at the Indicated Time Periods|The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).|Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)|Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.|||events|||Number
1294639|NCT00090103|Secondary|Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4|The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.|Years 1, 2, 3, and 4|ITT Population. As the study progressed, participants dropped out of the study.|||events|||Number
1294640|NCT00090103|Primary|Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.|A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.|Years 1, 2, 3, and 4|Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.|||events|||Number
1294641|NCT00090051|Secondary|Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment|Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population,all randomized participants, who started a new treatment for CLL or died.|||Days||95% Confidence Interval|Median
1294642|NCT00090051|Secondary|Final Analysis: Duration of Response|Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, with complete or partial response.|||Days||95% Confidence Interval|Median
1294643|NCT00090051|Secondary|Final Analysis: Time to Disease-Free Survival Event|Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, with complete response. .|||Days||95% Confidence Interval|Median
1294644|NCT00090051|Secondary|Final Analysis: Percentage of Participants With Complete Response|Complete response was defined as the disappearance of all signs of cancer in response to treatment.|Median observation time was approximately 5 years|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1294645|NCT00090051|Secondary|Final Analysis: Time to Event-Free Survival Event|Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, who had an EFS event. Participants who did not have an ESF event at the time of the final analysis were censored at the date of the last contact.|||Days||95% Confidence Interval|Median
1294646|NCT00090051|Secondary|Final Analysis: Time to Overall Survival Event|Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.|Median observation time was approximately 5 years|The analysis included only those participants from the Intent-to-treat population,all randomized participants, who died. Participants who had not died at the time of the final analysis were censored at the date of the last contact.|||Days||95% Confidence Interval|Median
1294647|NCT00090051|Primary|Final Analysis: Time to Progression-Free Survival Event|Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, who experienced a PFS event. Participants who did not have a PFS event at the time of the final analysis were censored at the date of the last contact.|||Days||95% Confidence Interval|Median
1294648|NCT00090051|Secondary|Number of Participants With Disease-free Survival (DFS) Events|Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population with a Best Overall Response of Complete Response.|||participants|||Number
1294649|NCT00090051|Secondary|Disease-free Survival (DFS)|Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population for patients with a Best Overall Response of Complete Response.|||Days||95% Confidence Interval|Median
1294650|NCT00090051|Primary|Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)|Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||participants|||Number
1294651|NCT00090051|Secondary|Number of Participants With Event-free Survival (EFS) Events|Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||participants|||Number
1294652|NCT00090051|Secondary|Event-free Survival (EFS)|Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||Days||95% Confidence Interval|Median
1294653|NCT00090051|Secondary|Number of Participants With Overall Survival (OS) Events|Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||participants|||Number
1294654|NCT00090051|Secondary|Overall Survival (OS)|Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||Days||95% Confidence Interval|Median
1294655|NCT00090051|Primary|Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||Days||95% Confidence Interval|Median
1294656|NCT00003224|Other Pre-specified|Number of Participants With a Proliferative Response to Tetanus Helper Peptide|Proliferative response measured in participants using a tritiated thymidine incorporation assay with peripheral blood mononuclear cells (PBMC) stimulated with the tetanus peptide in vitro, and measured at 5 days after in vitro culture.|during vaccination|All evaluable enrolled patients were assayed.|||participants|||Number
1294657|NCT00003224|Secondary|Immunogenicity of Each Vaccine Regimen|T cell responses to the p946 (gp100 [280-288]) peptide. All enrolled patients were assayed for immune response to the gp100 peptide by ELIspot assay after 14 days in vitro sensitization. The number with a response in each study arm is reported.|up to 12 months since enrollment||||participants|||Number
1294658|NCT00003224|Primary|Safety: Grade 3 Adverse Events|Adverse events are monitored according to NCI/DCT Common Toxicity Criteria|Up to 24 months after last vaccine||||participants|||Number
1294659|NCT00089999|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to study week 192)|Safety Population: all randomized participants who received at least one dose of investigational product.|||Participants|||Number
1294660|NCT00089999|Secondary|Time to Treatment Failure, as Assessed by IRC and Investigator|Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death due any cause. For participants who did not progress, die or discontinue early, time to treatment failure was censored at the last scan date.|From randomization until the first documented sign of disease progression, death due to any cause, or early discontinuation from investigational product (up to Study Week 103)|ITT Population|||Weeks||95% Confidence Interval|Median
1294661|NCT00089999|Secondary|Progression-free Survival, as Assessed by the IRC and Investigator|Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the IRC's and investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who did not progress, or die, progression-free survival was censored at the time of the last IRC assessed radiological scan.|From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 103)|ITT Population|||Weeks||95% Confidence Interval|Median
1294662|NCT00089999|Secondary|Duration of Response (DoR), as Assessed by the IRC and Investigator|DoR is defined for the subset of par. who had a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of >= 1 non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. For par. who did not progress or die, DoR was censored on the date of the last radiological scan. If a par.had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 103)|ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Weeks||Inter-Quartile Range|Median
1294663|NCT00089999|Secondary|Time to Response, as Assessed by the IRC and Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 103)|ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Weeks||Full Range|Median
1294664|NCT00089999|Secondary|Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator|Clinical benefit is defined as the numer of participants achieving either a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD,or complete resolution of TLs and the persistence of one or more non-TLs)or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new TLs or non-TLs and/or unequivocal progressionn of existing non-target lesions], taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.|From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer (up to Study Week 103)|ITT Population|||Percentage of Participants|||Number
1294665|NCT00089999|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)|ITT Population|||Participants|||Number
1294666|NCT00089999|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)|OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of investigational product.|||Participants|||Number
1294667|NCT00089986|Secondary|Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition or common toxicity criteria (CTC) grade 4 laboratory abnormalities of national cancer institute not associated with the underlying sepsis unless more severe than expected for the participants condition.|Day 1 (pre-infusion) up to Day 28 Follow-up|ITT Population.|||Participants|||Count of Participants
1294675|NCT00089973|Secondary|Number of Participants With Clinical Concern Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Temperature and Heart Rate|The vital sign examination included temperature, heart rate, SBP and DBP. Participant data for clinical concern vital parameters; SBP (unit: millimeter of Mercury [mmHg]: low concern (LC) and high concern (HC) values as 90 and 180 mmHg; DBP: LC and HC values as 40 and 100 mmHg; heart rate (units: beats per minute [bpm]): LC and HC as 50 and 140 bpm; and temperature (units: degree celsius): LC and HC as 36 and 41 degree Celsius; outside the mentioned range were reported. The available data for the participants from Cycle 1 (C1) Day 1 (D1); C2D1, C3D1, C4D1, C5D1, post-treatment and any visit post-screening were reported.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population.|||Participants|||Count of Participants
1294668|NCT00089986|Secondary|Number of Participants With New Onset Organ Failure of Respiratory Failure, Cardiovascular Failure, Renal Failure and Coagulopathy, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrollment|Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. For each organ failure type and the number of new onset organ failures per participants for each organ failure type, the denominator only included participants who did not have that type of organ failure at Baseline. At Baseline a participant could enter the study with a type of organ failure, that type of failure was not reported as a new onset organ failure.|Baseline (Day 1, pre-infusion) up to Day 28 Follow up|ITT Population. Organ failure occurring during the 28 days post-enrollment that was not in failure at enrollment. Participants who died prior to observing a new failure are excluded from analysis.|||Participants|||Count of Participants
1294669|NCT00089986|Secondary|Number of Participants With New Onset Organ Failure, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrolment|The new onset organ failure was defined as first time each of the following criteria were met after start of study medication up to Day 28. Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. Analysis was done treating the death as a new onset organ failure (counted in both the numerator and denominator).|Baseline (Day 1, pre-infusion) up to Day 28 Follow-up|ITT Population. Organ failure occurring during the 28 days post-enrollment that was not in failure at enrollment. Subjects who die prior to observing a new organ failure are counted as a failure.|||Participants|||Count of Participants
1294670|NCT00089986|Primary|Percentage of Participants With 28-Day All Cause Mortality|Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo – treatment.|Day 1 (post-infusion) up to Day 28 Follow-up|ITT Population was defined as all randomized participants from all three stages who receive any study drug.|||Percentage of participants|||Number
1294671|NCT00089973|Secondary|PK Parameter-Volume of Distribution|The assessment of volume of distribution for SB-715992 was planned to be collected on C1D1 at timepoints; pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours. Additional samples were to be collected in subsequent cycles, only if dose of study drug was adjusted for any reason following Cycle 1. However, the data for analysis of PK parameter was not collected.|Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months|Data for PK parameter 'Volume of distribution' was not collected.||||||
1294672|NCT00089973|Secondary|Pharmacokinetic (PK) Parameter-Clearance|The assessment of clearance for SB-715992 was planned to be collected on C1D1 at timepoints; pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours. However, the data for analysis of PK parameter was not collected.|Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months|The data for the outcome 'PK parameter-clearance' was not collected||||||
1294673|NCT00089973|Secondary|Number of Participants With Toxicity Shift Grade From Baseline for Clinical Chemistry Grade Shifts|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. A total of 45 to 46 milliliter (ml) of blood over a 21-day cycle of treatment was collected. For clinical chemistry, the parameters assessed were Alanine transaminase (ALT), Aspartate transaminase (AST), Hemoglobin, lymphocytes, neutrophils, platelet count, white blood cell (WBC), albumin, alkaline phosphatase increased, total bilirubin, calcium, creatinine, glucose, potassium and sodium. The toxicities for the clinical chemistry parameters were graded according to the NCI-CTCAE, version 3.0. where; G 0= None (normal limits); G1= Mild, G2=Moderate; G3=Severe; G4= Fatal. The number of participants with toxicity shift grades for clinical chemistry were reported.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population.|||Participants|||Count of Participants
1294674|NCT00089973|Secondary|Number of Participants With Toxicity Shift Grade From Baseline for Hematology Parameters|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. A total of 45 to 46 milliliter (ml) of blood over a 21-day cycle of treatment was collected. For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, Red blood cell count, white blood cell count (WBC), lymphocytes, monocytes, granulocytes, neutrophils, ,eosinophils and basophils. The toxicities for the hematology parameters were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. Grade (G) 0= None (normal limits); G1= Mild, G2=Moderate; G3=Severe; G4= Fatal. The toxicity shift grades for Hemoglobin, Lymphocytes, Neutrophils, platelet count and WBC, were reported.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X) in the category titles).|||Participants|||Count of Participants
1294709|NCT00089661|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294710|NCT00089661|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294676|NCT00089973|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|From first dose of study drug (Day 1) to 30 days after the last dose (up to 26 months)|ITT population.|||Participants|||Count of Participants
1294677|NCT00089973|Secondary|Median Time-to-progression After Administration of Inspinesib|Time-to-progression was defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, if sooner. The PD as per RECIST criteria 1.0 was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For participants who did not progress or die, time-to-progression was censored at the time of initiation of alternative anti-cancer therapy or time of last contact, if sooner.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population|||week||95% Confidence Interval|Median
1294678|NCT00089973|Secondary|Duration of Response|For the participants who had a CR or PR, duration of response was defined as the time a CR or PR was first documented, until the first documented sign of disease progression or death. CR for TLs was defined as disappearance of all TLs and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD. The PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For participants who did not progress or die, duration of response would be censored at the time of initiation of alternative anti-cancer therapy or time of last contact, if sooner. Due to small number of participants with a response, data was not summarized; however, individual participants data is reported week wise.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population. Only those participants available at that particular timepoints were analyzed|||Weeks|||Number
1294679|NCT00089973|Secondary|Median Time to Response|Time to response was defined as the time between the start of first dose of the study drug until the first documented evidence of partial or complete tumor response (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken as the first time the response was observed. For participants who did not show a tumor response, the time was censored at the time of withdrawal from the study for any reason. It was evaluated using RECIST criteria 1.0. CR for TLs was defined as Disappearance of all TLs and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population|||weeks||95% Confidence Interval|Median
1294680|NCT00089973|Primary|Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib|Overall tumor response rate, was defined as the percentage of participants achieving either a complete response (CR) or partial response (PR), stable disease (SD), or progressive disease (PD). It was assessed by Computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The target lesions (TLs): CR, Disappearance of all TLs; PR where at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD; PD : At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|Intent to treat population consisted of all participants (n=50) who received at least one dose of study drug.|||percentage of participants|||Number
1294681|NCT00089895|Secondary|Incidence of the Composite of Death/MI.||30 days after randomization|Intent to treat population|||percentage of participants|||Number
1294682|NCT00089895|Primary|Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.||96 hours after randomization|Intent to treat population|||percentage of participants|||Number
1294683|NCT00089843|Secondary|Markers of Bone Metabolism|type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change.|Baseline to 12 months|1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.|||percent change of CTX||95% Confidence Interval|Mean
1294684|NCT00089843|Primary|Bone Mineral Density|Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change.|Baseline and 12 months|1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.|||percent change||95% Confidence Interval|Mean
1294685|NCT00089791|Secondary|Number of Participants With a Hip Fracture|Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.|36 months|Full analysis set|||Participants|||Number
1294711|NCT00089661|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294712|NCT00089661|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294686|NCT00089791|Secondary|Number of Participants With Nonvertebral Fractures|Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary.|36 months|Full analysis set (all randomized participants)|||Participants|||Number
1294687|NCT00089791|Primary|Number of Participants With New Vertebral Fractures|A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms [or both] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture).|36 months|Primary Efficacy Analysis Set, which includes all randomized participants who have a baseline and ≥ 1 postbaseline evaluation of vertebral fracture at or before 3 years. Last Observation Carried Forward was used.|||Participants|||Number
1294688|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.|Baseline and after 8 weeks of treatment in ITT sample|The Intent-to-Treat Sample includes all randomized patients exposed to CPAP or Sham treatment during the post randomization treatment period.|||scores on a scale||Standard Deviation|Mean
1294689|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.|Baseline and Week 8 of treatment in ITT sample.|The Intent-to-Treat Sample includes all randomized patients exposed to CPAP or Sham treatment during the post randomization treatment period.|||scores on a scale||Standard Deviation|Mean
1294690|NCT00089752|Secondary|Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the PVT is an objective assessment of sleepiness and measures decrements in neurobehavioral performance due to sleepiness, i.e., ability to sustain attention and respond in a timely manner to salient signals.(7) The PVT yields five highly informative metrics on the capacity for sustained attention and vigilance performance: frequency of lapses, duration of lapse domain, optimum response time, vigilance decrement function, false response frequency. We applied this conceptually valid, relatively short duration, reliable task with known psychometric properties and minimal practice/learning curves to document attentional lapses (response times > 500 msec) in performance.|Baseline and 8 weeks of treatment in the ITT sample|The Intent-to-Treat Sample includes all randomized patients receiving at least a 20 minute interval of Active during the post randomization treatment period and who had no clinically significant major violations of inclusion or exclusion criteria.|||number on a scale||Standard Deviation|Mean
1294691|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the POMS is a reliable and valid measure of mood states that consists of 65 adjectives on which subjects’ rate themselves as they feel “today” using a five-point scale. There are six mood or affective states on this test derived through factor analysis: Tension-Anxiety (score range 0-36), Depression-Dejection (score range 0 - 60), Anger-Hostility (score range 0-48), Vigor-Activity (score range 0-32), Fatigue-Inertia (score range 0-28), and Confusion-Bewilderment (score range 0-28). There is also a summary Total Mood Disturbance (TMD) score that gives a Total estimate of affective state score range 0-200). Higher scores indicate greater disability.|Measured at Baseline and Week 8 treatment in the ITT sample|Population who had data post-randomization following 8 wks. intervention - ITT analysis|||scores on a scale||Standard Deviation|Mean
1294692|NCT00089752|Secondary|Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment|Change in mean arterial pressure (MAP) value from baseline to 8 weeks treatment, controlling for baseline, measured by 48 hours ambulatory blood pressure device - Space Laboratories|Measured at Baseline and Week 8 treatment in the ITT sample|Population who had data post-randomization following 8 wks. intervention - ITT analysis|||mmHg||Standard Deviation|Mean
1294693|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale|Change in the score from baseline to 8 weeks treatment, controlling for baseline in the self-rated 8 item measure of daytime sleepiness with a range from 0 - 24. Lower values indicting less daytime sleepiness|Measured at Baseline and Week 8 of treatment in ITT sample|Participants randomized and who had post-treatment data in ITT analysis|||scores on a scale||Standard Deviation|Mean
1294694|NCT00089752|Primary|Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment|The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5–30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.|8 weeks|Consented and randomized participants who completed the FOSQ with mild or moderate obstructive sleep apnea.|||scores on a scale||Standard Deviation|Mean
1294695|NCT00089778|Primary|Immunologic Response to Peptide Vaccination Pre and Post Vaccination|FGF-5 specific CTL (cytotoxic T lymphocytes) may be tested by cytokine release assay or ELISPOT (enzyme linked immunosorbent spot) assay using tumor, FGF-5 transfected or peptide-loaded target cells and compared to pre-treatment peripheral blood mononuclear cells (PBMC) to determine immune response to vaccination. In the assays, differences of 2-3 fold are indicative of true biologic difference.Due to text data entry field limitations, Pre vaccination and post vaccination will be shown in the results as Pre V and Post V, respectively. Patients entered in Group A did not complete sufficient vaccinations to permit immunological evaluation and in Group B, the co-administration of IL-2 is known to corrupt immunological evaluation (so only clinical responses are valid). Expanding information on cancer vaccines in general as wells as preliminary information from this trial on FGF-5 as a vaccine target both served to render the enrollment of additional patients to this trial obsolete.|24 hours|“1 uM A3 culture vs tranfectant” means “Immune cells cultured with the concentration of 1 uM of the A3 peptide were tested against [with] target cells into which the FGF-5 target gene was inserted [transfected with] and the release of interferon is measured to detect immune recognition”.Documentation was only available for the 4 patients.|||pg/ml/24 hrs|||Number
1294696|NCT00089778|Primary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|47 months||||Participants|||Count of Participants
1294697|NCT00089778|Primary|Response|Overall response is defined as the best response (e.g. complete response...) recorded from the start of treatment until disease progression/recurrence. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of LD of target lesions since the treatment started or the appearance of new lesion. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|3 years and 9 months|Pts in Group C had no evaluable disease,response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).|||Participants|||Count of Participants
1294698|NCT00089674|Secondary|Number of Participants With Any Fracture Through Month 24|Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.|24 months|Full analysis set|||Participants|||Number
1294699|NCT00089674|Secondary|Time to First Clinical Fracture Through Month 36|A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture.|36 months|Full analysis set|||Percentage of participants|||Number
1294700|NCT00089674|Secondary|Number of Participants With a New Vertebral Fracture Through Month 36|New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture.|36 months|All randomized subjects who have a baseline and >= 1 postbaseline evaluation of vertebral fracture at or before 3 years.|||Participants|||Number
1294701|NCT00089674|Secondary|Number of Participants With Any Fracture Through Month 36|Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.|36 months|Full analysis set|||Participants|||Number
1294702|NCT00089674|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294703|NCT00089674|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294704|NCT00089674|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294705|NCT00089674|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294706|NCT00089674|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294707|NCT00089674|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294708|NCT00089661|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
1294716|NCT00089648|Secondary|Plasma Concentration of Placental Growth Factor (PlGF)|Plasma concentrations of PlGF that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28)|ITT|||pg/mL||Full Range|Mean
1294717|NCT00089648|Secondary|Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)|Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)|ITT|||pg/mL||Full Range|Mean
1294718|NCT00089648|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)|Plasma concentrations of VEGF-A that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)|ITT|||pg/mL||Full Range|Mean
1294719|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)||Day 28 of Cycle 1 to Cycle 4|ITT|||ng/mL||Full Range|Median
1294720|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of SU012662||Day 28 of Cycle 1 to Cycle 4|ITT|||ng/mL||Full Range|Median
1294721|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of Sunitinib||Day 28 of Cycle 1 to Cycle 4|ITT|||ng/mL||Full Range|Median
1294722|NCT00089648|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from start of study medication to first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT. 20 subjects were censored.|||weeks||Full Range|Median
1294723|NCT00089648|Secondary|Overall Survival (OS)|OS was defined as the time from start of study treatment to date of death due to any cause. OS (in weeks) was calculated as [date of death minus first dose date +1]/7. For a subject not expiring, the OS time was censored on the last date of known contact that they were known to be alive. Subjects lacking data beyond the day of the first dose had their OS times censored at 1 day. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT|||weeks||95% Confidence Interval|Median
1294724|NCT00089648|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was only calculated for the subgroup of subjects with a confirmed objective response. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT subjects (i.e, all subjects enrolled in the study that received at least 1 dose of study medication) who had a confirmed CR or PR. 14 subjects who had a response were analyzed for DR.|||weeks||95% Confidence Interval|Median
1294725|NCT00089648|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to the date of the first documentation of tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT. 20 subjects were censored.|||weeks||95% Confidence Interval|Median
1294726|NCT00089648|Primary|Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|Intent-to-treat (ITT)=all subjects enrolled in the study that received at least 1 dose of study medication.|||participants|||Number
1294727|NCT00089635|Secondary|Overall Survival|Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||months||95% Confidence Interval|Median
1294728|NCT00089635|Secondary|Duration of Stable Disease|"Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.~Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started."|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a best response of stable disease.|||weeks||95% Confidence Interval|Median
1294759|NCT00089583|Secondary|Plasma RTV CL/F Following Dosing Expressed in mg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ).|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||mL/min||95% Confidence Interval|Geometric Mean
1294729|NCT00089635|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), for whom a decision was made to end treatment for any reason.|||weeks||95% Confidence Interval|Median
1294730|NCT00089635|Secondary|Time to Disease Progression|Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||weeks||95% Confidence Interval|Median
1294731|NCT00089635|Secondary|Progression-free Survival Time|Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||weeks||95% Confidence Interval|Median
1294732|NCT00089635|Secondary|Time to Initial Objective Response|Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had an objective tumor response at any time on study.|||weeks||Full Range|Median
1294733|NCT00089635|Secondary|Objective Tumor Response Throughout the Study|Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||participants|||Number
1294734|NCT00089635|Primary|Duration of Response|Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response at any time on study.|||weeks||95% Confidence Interval|Median
1294735|NCT00089635|Primary|Objective Tumor Response Through Week 16|Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.|From enrollment through Week 16|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||participants|||Number
1294736|NCT00089583|Secondary|Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events|No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.|Week 48|PK Population||||||
1294737|NCT00089583|Secondary|Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire|The PACTG Adherence Questionnaire records individual study drugs, the expected number of doses/24 hour period, and the number of doses missed in the 3 days prior to the study visit. Responses were summarized by age cohort, study drug, treatment regimen, and visit for exploratory analysis only.|Weeks 2, 12, 24, and 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1294760|NCT00089583|Secondary|Plasma RTV CL/F Following Dosing Expressed in mg/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: RTV Dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||mL/min/kg||95% Confidence Interval|Geometric Mean
1294738|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Week 60 through Week 240|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable|||Participants|||Number
1294739|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Baseline through 48 Weeks|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable|||participants|||Number
1294740|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|After Week 48 through Week 240|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.|||Participants|||Number
1294741|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.|||participants|||Number
1294742|NCT00089583|Secondary|Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Week 2, 12, 24, 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.|||Percentage of TLs that are CD4+ cells||Inter-Quartile Range|Median
1294743|NCT00089583|Secondary|Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.|||Percentage of TLs that are CD4+ cells||Inter-Quartile Range|Median
1294744|NCT00089583|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.|||cells/cu mm||Inter-Quartile Range|Median
1294761|NCT00089583|Secondary|Plasma RTV Cτ|The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
1294745|NCT00089583|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.|||Cells per cubic millimeter (cells/cu mm)||Inter-Quartile Range|Median
1294746|NCT00089583|Secondary|Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||participants|||Number
1294747|NCT00089583|Secondary|Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. Change from Baseline at Weeks 2, 12, 24, and 48 was calculated as value at Week 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||log10/copies||Inter-Quartile Range|Median
1294748|NCT00089583|Secondary|Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||log10 copies/mL||Inter-Quartile Range|Median
1294749|NCT00089583|Secondary|Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation = Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 2, 12, 24, and 48|Intent-to-Treat Exposed (ITT-E) Population. Only those par. contributing data at the indicated time points were analyzed. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||participants|||Number
1294750|NCT00089583|Secondary|Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced.Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons, (c) missing data during window but still on study.|Week 48|Intent-to-Treat Exposed (ITT-E) Population: par. with documented evidence of receiving >=1 treatment dose. Only par. contributing data were analyzed. The number of par. analyzed is the sum of the PI-naïve (received <1week's treatment with a PI) and -experienced (received >1week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||participants|||Number
1294751|NCT00089583|Secondary|Plasma FPV t1/2|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1294752|NCT00089583|Secondary|Plasma FPV Tmax|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1294753|NCT00089583|Secondary|Plasma FPV CL/F Following Dosing Expressed in mg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1294754|NCT00089583|Secondary|Plasma FPV CL/F Following Dosing Expressed in mg/kg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1294755|NCT00089583|Secondary|Plasma FPV Cmax and Cτ|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1294756|NCT00089583|Secondary|Plasma FPV AUC (0-τ)|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1294757|NCT00089583|Secondary|Plasma RTV t1/2|alf-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||hours||95% Confidence Interval|Geometric Mean
1294758|NCT00089583|Secondary|Plasma RTV Tmax|The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax).|Week 48|PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||hours||Full Range|Median
1294762|NCT00089583|Secondary|Plasma RTV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
1294763|NCT00089583|Secondary|Plasma Ritonavir (RTV) AUC (0-τ)|Plasma samples were assayed for RTV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.|Week 48|PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data were analyzed.|||hr*µg/mL||95% Confidence Interval|Geometric Mean
1294764|NCT00089583|Primary|Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities|"A toxicity was considered TE if it was > than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Leucopenia is the decrease in the number of leucocytes (white blood cells [WBCs]); neutropenia is the decrease in the number of neutrophils (type of WBCs). Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs: Grade 3 is severe; Grade 4 is potentially life-threatening. ULN, upper limit of normal; LDL, low-density lipoprotein; PC, platelet count."|Baseline (Day 1) until Week 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1294765|NCT00089583|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48|Blood samples of the participants were collected for the evaluation of AST and ALT. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in AST and ALT was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.|||International units per liter (IU/L)||Inter-Quartile Range|Median
1294766|NCT00089583|Primary|Change From Baseline in Serum Lipase at Week 48|Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.|||Units per liter (U/L)||Inter-Quartile Range|Median
1294767|NCT00089583|Primary|Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48|Blood samples of all participants were collected under fasting conditions for the evaluation of triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.|||Millimoles per liter (mmol/L)||Inter-Quartile Range|Median
1294768|NCT00089583|Primary|Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 48|Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment.|||participants|||Number
1294769|NCT00089583|Primary|Plasma APV t1/2|The apparent terminal phase half-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.|Week 48|PK Population. Only those participants contributing data were analyzed.|||hours||95% Confidence Interval|Geometric Mean
1294770|NCT00089583|Primary|Plasma APV Tmax|The time to reach the maximum concentration (Cmax) at steady state is defined as tmax.|Week 48|PK Population. Only those participants contributing data were analyzed.|||hours||Full Range|Median
1294771|NCT00089583|Primary|Plasma APV CL/F Following Dosing Expressed in mg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).|Week 48|PK Population. Only those participants contributing data were analyzed.|||Milliliters per minute (mL/min)||95% Confidence Interval|Geometric Mean
1294772|NCT00089583|Primary|Plasma APV CL/F Following Dosing Expressed in mg/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Milliliters/minute/kilogram (mL/min/kg)||95% Confidence Interval|Geometric Mean
1294773|NCT00089583|Primary|Plasma APV Cτ|The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1294774|NCT00089583|Primary|Plasma APV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1294786|NCT00089609|Primary|Number of Participants Who Had a Prostate-specific Antigen (PSA) Response|PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression.|21.6 months|The main cohort was designed to evaluate clinical progression and the expansion cohort was designed to evaluate immune response. Thus the expansion cohort is not included here.|||Participants|||Count of Participants
1294787|NCT00089544|Secondary|Response to Pre-operative Therapy Assessed Using RECIST Criteria||From start of treatment to time of surgery.|"This analysis was not carried out due to the small number of patients accrued to the study. See section Limitations and Caveats."||||||
1294775|NCT00089583|Primary|Plasma Amprenavir (APV) AUC (0-tau[τ])|Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hr, hour; µg, micrograms; mL, milliliter.|Week 48|Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.|||hr*µg/mL||95% Confidence Interval|Geometric Mean
1294776|NCT00089609|Secondary|Changes in the Molecular Markers of Angiogenesis (Including, But Not Limited to Serum and Urine Vascular Endothelial Growth Factor (VEGF)) Before and After Administration of Docetaxel, Prednisone, Thalidomide and Bevacizumab||Baseline and monthly|The outcome was not assessed. In the study, assessment of circulating apoptotic endothelial cells was the main outcome evaluated for assessing the treatment's antiangiogenic activity. Changes in the molecular markers of angiogenesis will not be pursued.||||||
1294777|NCT00089609|Secondary|Usefulness of Dynamic Magnetic Resonance Imaging (MRI) to Monitor the Progression of Bony and Soft Tissue Disease in Metastatic Prostate Cancer|Target lesions in the bone or soft tissues will be identified from the participant computed tomography (CT) scan. Dynamic MRI will be performed after the intravenous administration of 0.1 mmol/kg of Gadolinium chelate. Progression is defined by the RECIST criteria and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment starts or the appearance of new lesions.|Baseline and at 3 month intervals until progression|The outcome was not assessed as the functionality of dynamic MRI in prostate cancer was poor at the time of this study. Earlier prostate MRI techniques suffered from poor sensitivity and specificity for monitoring progression.||||||
1294778|NCT00089609|Secondary|Analyze the Patients Genotype With Regard to Cytochrome P450 2C19 Polymorphism and Correlate That With Pharmacokinetics and Efficacy|Single nucleotide polymorphisms in genes that play an important role in eliminations pathways for docetaxel (in the CYP3A4 and CYP3A5 genes) and thalidomide (CYP2C19) will be evaluated.|Patient entry onto the study|The outcome was not assessed as the clinical significance of cytochrome P450 2C19 polymorphism in angiogenesis is undetermined. This analysis will not be pursued.||||||
1294779|NCT00089609|Secondary|Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level|"The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and < PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, significant increase is dependent upon this comparison and varies between patients."|Baseline and at 6 weeks (after two cycles of treatment)|Only 17/60 participants were evaluable for this outcome. Per protocol CAECs were not assessed in the expansion cohort.|||Participants|||Count of Participants
1294780|NCT00089609|Secondary|Plasma Concentrations of Docetaxel and Thalidomide and Clinical Activity or Toxicity|The analysis will be performed using a validated method based on liquid chromatography with mass-spectrometric detection.|Pre-dose on C1D1, 5 minutes before the end of infusion, and 15, and 30 minutes, and 1, 2,4,8, and 24 hours after the end of infusion|The outcome was not assessed as the analysis of plasma bevacizumab concentrations was the main pharmacokinetic secondary outcome in the study. The plasma levels of docetaxel and thalidomide (without bevacizumab) had minimal significance in this study. Analysis of plasma concentrations of docetaxel and thalidomide will not be done.||||||
1294781|NCT00089609|Secondary|Number of Participants Who Died After a Follow Up of 34 Months Following Treatment|From on study date to date of death at 34 months.|34 months|Per protocol, this outcome was not assessed for the expansion cohort.|||Participants|||Count of Participants
1294782|NCT00089609|Secondary|Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)|Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions.|up to 34 months|"Only 33/60 participants had measurable disease and were evaluable for this outcome measure.~Per protocol, disease progression by clinical and radiographic criteria without the use of PSA was not assessed for the expansion cohort."|||Participants|||Count of Participants
1294783|NCT00089609|Secondary|Time to Progression Using Bubley Criteria|Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period.|up to 40 months|Per protocol, time to progression using Bubley Criteria was not assessed for the expansion cohort.|||Months||95% Confidence Interval|Median
1294784|NCT00089609|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|37 months||||Participants|||Count of Participants
1294785|NCT00089609|Primary|Immune Response|Cellular immune response and cytokines were evaluated after two cycles of therapy in the expansion cohort. Those cycles included treatment with bevacizumab and docetaxel as a pre-medication.|6 weeks|Cellular immune response and cytokines were not analyzed as the study outcomes were concentrated on the dual-anti-angiogenesis inhibition properties of the regimen and not immunomodulatory changes.||||||
1295871|NCT00075829|Primary|Progression-Free Survival (PFS)|Patients are considered a failure for this endpoint if they die or if they progress or relapse.|Year 3|Patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
1294788|NCT00089544|Secondary|Wound Complication (Grades 2, 3, 4, and 5) as Measured by CTCAE v3.0|Will be estimated using a binomial distribution and accompanied by the associated 95% confidence interval.|From start of treatment to time of surgery|"This analysis was not carried out due to the small number of patients accrued to the study. See section Limitations and Caveats."||||||
1294789|NCT00089544|Primary|Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation|Was to be estimated using a binomial distribution and accompanied by the associated 95% confidence interval. Due to early study closure, this endpoint could not be fully evaluated per the protocol plan.|Duration of treatment (which can continue up to approximately 15 months).|Eligible patients who started study treatment.|||participants|||Number
1294790|NCT00089505|Secondary|Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month|Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.|Numbers presented use as-treated approach.|||percent of participants|||Number
1294791|NCT00089505|Secondary|Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality|Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.|Numbers presented use the as-treated approach.|||participants|||Number
1294792|NCT00089505|Primary|Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry|5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.|The analysis was intent to treat per protocol.|||weeks||95% Confidence Interval|Number
1294793|NCT00089505|Primary|Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry|5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||weeks||95% Confidence Interval|Number
1294794|NCT00089505|Secondary|Number of Participants Who Experienced HIV-related Disease Progression or Death|Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||participants|||Number
1294795|NCT00089505|Secondary|Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.|The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use as-treated method.|||participants|||Number
1294796|NCT00089505|Secondary|CD4 Count Change From Randomization|Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.|Changes were calculated using the intent-to-treat approach (i.e. ignoring changes from randomized treatment) but no imputation was done for missing values.|||cells/mm^3||Inter-Quartile Range|Median
1294797|NCT00089505|Secondary|Percent of Participants Who Experienced Virologic Failure or Died|Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||Percent of participants||95% Confidence Interval|Number
1294848|NCT00089011|Primary|Incidence of Chronic Extensive GVHD|Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.|Day 180 post-transplantation||||Participants|||Count of Participants
1294798|NCT00089505|Secondary|Number of Participants Who Experienced Virologic Failure or Died.|Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||participants|||Number
1294799|NCT00089479|Secondary|Disease Free Survival Including Any New Cancer as Event [Time to Event]|Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
1294800|NCT00089479|Secondary|Disease Free Survival Including Any New Cancer as Event [Number of Events]|Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||participants|||Number
1294801|NCT00089479|Secondary|Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event|Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
1294802|NCT00089479|Secondary|Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]|Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||participants|||Number
1294803|NCT00089479|Secondary|Breast Cancer Free Survival [Time to Event]|Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
1294804|NCT00089479|Secondary|Breast Cancer Free Survival [Number of Events]|Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.|Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .|Intent−to−Treat Population|||participants|||Number
1294805|NCT00089479|Secondary|Overall Survival [Time to Event]|Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.|Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
1294806|NCT00089479|Primary|Disease Free Survival [Time to Event]|Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
1294807|NCT00089479|Secondary|Overall Survival [Number of Events]|Number of patients who died/were alive.|Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||participants|||Number
1294808|NCT00089479|Primary|Disease Free Survival [Number of Events]|Number of patients with/without recurrence of breast cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||participants|||Number
1294809|NCT00089414|Secondary|Change in Beck Depression Inventory (BDI) Factors Associated With Premenstrual Symptoms|"The Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Total scores are interpreted per these ranges:~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression."|Every 2 weeks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.||||||
1294810|NCT00089414|Primary|Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.|The PMTS observer scales assess symptoms in ten different domains including irritability-hostility; tension; efficiency; dysphoria; moodiness; motor coordination; mental-cognitive functioning; eating habits; sexual drive and activity; physical symptoms and social impairment. They have been used to measure premenstrual symptom severity and response to treatment in several clinical trials and prevalence studies. Score ranges from no symptoms to severe symptoms on a scale of 0 to 6, with 0 being no symptoms and 6 being severely symptomatic.|Every 2 weeks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.||||||
1294811|NCT00089414|Secondary|Change in Clinical Global Impression Scale (CGI) Factors Associated With Premenstrual Symptoms.|The CGI was developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication.1 The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI actually comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale, with 1 being normal/more improved and 7 being severe/worse.|Every 2 wks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.||||||
1294812|NCT00089297|Secondary|Overall Survival|Overall survival is defined as the time from registration to death of any causes.|Weekly during treatment, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in the analysis.|||Months||95% Confidence Interval|Median
1294813|NCT00089297|Secondary|Progression-free Survival|Progression-free survival was defined as the time from registration to documented progression or death without progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in the analysis.|||Months||95% Confidence Interval|Median
1294814|NCT00089297|Secondary|Proportion of Patients With Objective Response by RECIST|Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in this analysis.|||proportion of patients||95% Confidence Interval|Number
1294815|NCT00089297|Primary|Event-free Survival Rate at 1 Year|Event-free survival rate at 1 year was defined as the proportion of patients who did not have disease progression, primary site surgery, or death after being followed for 1 year.|Assessed at 1 year.|Only eligible patients are included in the analysis.|||proportion of patients||95% Confidence Interval|Number
1294816|NCT00089141|Secondary|End of Systemic Treatment|Withdrawal of all immunosuppressive treatment without recurrent malignancy|within 4 years||||participants|||Number
1294817|NCT00089141|Secondary|Withdrawal of Prednisone|Withdrawal of treatment with prednisone after improvement or resolution of chronic GVHD|within 4 years||||participants|||Number
1294818|NCT00089141|Secondary|Death|Death from any cause after enrollment in the study|within 4 years||||participants|||Number
1294819|NCT00089141|Secondary|Death or Recurrent Malignancy|Death due to any cause or development of recurrent malignancy at any time after enrollment|within 4 years||||participants|||Number
1294820|NCT00089141|Secondary|Non-relapse Mortality|Death without prior development of recurrent malignancy|within 4 years||||participants|||Number
1294821|NCT00089141|Secondary|Recurrent Malignancy|Development of recurrent malignancy after enrollment in the study|within 4 years||||participants|||Number
1294822|NCT00089141|Secondary|Bronchiolitis Obliterans|Development of bronchiolitis obliterans during treatment|within 4 years||||participants|||Number
1294823|NCT00089141|Secondary|Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy|Administration of any systemic therapy other than the immunosuppressive agents used for initial treatment, because of persistent or progressive chronic graft-versus-host disease|2 years||||participants|||Number
1294824|NCT00089141|Secondary|Definitive Absence of Efficacy Success|Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy|2 years||||participants|||Number
1294825|NCT00089141|Primary|Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy|Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy|2 years||||participants|||Number
1294826|NCT00089128|Secondary|Progression-free Survival||Time between registration and disease progression or death, whichever comes first.|data for this endpoint was not collected||||||
1294827|NCT00089128|Secondary|Frequency of Adverse Events as Assessed by NCI CTC Version 2.0||From the day of first dose until the end of study, an average of 6 months|data for this endpoint was not collected||||||
1294828|NCT00089128|Secondary|Duration of Response||From registration until disease progression among patients who had at least a partial response.|Data for this endpoint was not collected||||||
1294829|NCT00089128|Primary|Response Proportion||From registration until time of complete response or partial response|Data for this endpoint was not collected||||||
1294830|NCT00089102|Secondary|Progression-free Survival||Time between registration and disease progression or death, whichever comes first.|Data for this endpoint was not collected||||||
1294831|NCT00089102|Secondary|Number of Participants Who Experienced SAEs on Study||From the day of first dose until the end of study, for an average of 6 months||||Participants|||Count of Participants
1294832|NCT00089102|Secondary|Duration of Response||From registration until disease progression among patients who had at least a partial response|Data is not available for this endpoint was not collected.||||||
1294833|NCT00089102|Primary|Response Proportion||From registration until time of complete response or partial response|All patients treated on study who underwent a response assessment|||Participants|||Count of Participants
1295872|NCT00075816|Secondary|Patient Quality of Life||Measured at baseline, 6 months, and 1, 2, and 5 years|No data collected||||||
1295873|NCT00075816|Secondary|Donor Quality of Life||Measured at 1, 6, and 12 months|No data collected||||||
1294834|NCT00089076|Secondary|Mean Change in % of CD3+CD4- for the Marker CD45RO+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.|||percentage of change of CD3+CD4-||Standard Error|Mean
1294835|NCT00089076|Secondary|Mean Change in % of CD3+CD4+ for Marker CD45RO+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.|||percentage of change of CD3+CD4+||Standard Error|Mean
1294836|NCT00089076|Secondary|Mean Change in % of CD3+CD4- for Marker HLA-DR+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.|||percentage of change of CD3+CD4-||Standard Error|Mean
1294837|NCT00089076|Secondary|Mean Change in % of CD3+CD4+ for Marker HLA-DR+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.|||percentage of change of CD3+CD4+||Standard Error|Mean
1294838|NCT00089076|Secondary|Duration of Response (Phase 2)|Duration of response will be calculated from the documentation of confirmed response until the date of progression in the subset of patients who respond.|From response to progression (up to 2 years)|No participants proceeded to Phase 2 for evaluation.||||||
1294839|NCT00089076|Secondary|Overall Survival (Phase 2)|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|From registration to death (up to 2 years)|No participants proceeded to Phase 2 for evaluation.||||||
1294840|NCT00089076|Secondary|Time to Progression (Phase 2)|The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|From registration to progression (up to 2 years)|No participants proceeded to Phase 2 for evaluation.||||||
1294841|NCT00089076|Primary|Number of Overall Confirmed Responses(Complete Response or Partial Response)|Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.|From registration to month 7||||participants|||Number
1294842|NCT00089011|Secondary|Rate and Duration of Steroid Use for the Treatment of Chronic GVHD|Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone.|Up to 5 years|Only those patients who received steroids for treatment of chronic GVHD.|||days||Full Range|Median
1294843|NCT00089011|Secondary|Rates of Relapse-related Mortality|Number of patients who expired with relapsed/progressive disease.|Up to 5 years||||Participants|||Count of Participants
1294844|NCT00089011|Secondary|Rates of Disease Progression|"Relapse/Progression criteria:~CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~CMML, AML, ALL >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.~CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|Up to 5 years||||Participants|||Count of Participants
1294845|NCT00089011|Secondary|Incidences of Grades II-IV Acute GVHD|"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Day 180 post-transplantation||||Participants|||Count of Participants
1294846|NCT00089011|Secondary|Overall Survival|Number of patients surviving post-transplant.|At 1 year after conditioning||||Participants|||Count of Participants
1294847|NCT00089011|Secondary|Incidences of Graft Rejection|Number of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT.|Day 180 post-transplantation||||Participants|||Count of Participants
1295789|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1294849|NCT00089011|Primary|Incidence of Grade III/IV GVHD|"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Day 180 post-transplantation||||Participants|||Count of Participants
1294850|NCT00088985|Secondary|Immune Response|Measured by intracellular cytokine staining for Interferon-gamma (INFgamma) and cluster of differentiation (CD107) up regulation and tetramer. A fourfold increase in the number of cluster of differentiation (CD8+) tetramers comparing prevaccine with peak postvaccine values indicated an immune response to the therapy.|3 months following treatment||||Participants|||Count of Participants
1294851|NCT00088985|Primary|Overall Response Rate|"Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response)~Complete Response (CR)− Disappearance of all target lesions~Partial Response (PR)−at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter."|6 months following treatment||||Participants|||Count of Participants
1294852|NCT00088972|Secondary|Ki-67 Expression|The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).|1 year|Since the study was closed early due to insufficient accrual, the ki-67 data were never collected.||||||
1294853|NCT00088972|Primary|Mammographic Density|The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.|1 year|Counts represent number of patients for by arm for whom a 1 year mammographic density image was submitted. However, since the study was closed early due to poor accrual, there was insufficient accrual to evaluate study endpoints, and these images were never analyzed.||||||
1294854|NCT00088907|Secondary|Overall Response Rate|"Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.~Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles).~All eligible and treated patients were included in the analysis."|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
1294855|NCT00088907|Secondary|Time to Progression|"Time to progression is defined as time from registration to disease progression. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .~Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles).~All eligible and treated patients were included in the analysis."|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients|||months||95% Confidence Interval|Median
1294856|NCT00088907|Primary|Overall Survival|Overall survival is defined as time from registration to death from any cause. All eligible and treated patients were included in the analysis.|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients|||months||95% Confidence Interval|Median
1294857|NCT00088881|Secondary|3-year Overall Survival (OS) Rate|Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.|Eligible and treated patients|||probability||95% Confidence Interval|Number
1294858|NCT00088881|Secondary|3-year Time to Treatment Failure (TTF) Rate|Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years.|Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.|Eligible and treated patients|||probability||95% Confidence Interval|Number
1294859|NCT00088881|Primary|Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.|Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of >50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by >50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease.|Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin|Eligible and treated patients.|||proportion of participants||95% Confidence Interval|Number
1294860|NCT00088881|Primary|Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.|Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently > 1.5 cm in greatest diameter that has decreased by > 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by > 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).|Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin|Eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
1294861|NCT00088829|Primary|Overall Response|Due to the early termination of the study, this data for this outcome was not collected.|3 months|||||||
1294862|NCT00088699|Primary|MADRS Score - Day 1 Following Intervention|Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.|Day 1|The analyses included subjects who were given Ketamine or Placebo.|||units on a scale||Standard Deviation|Mean
1294863|NCT00088699|Primary|MADRS Score - Baseline|Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.|Baseline|The analyses included subjects who were given Ketamine or Placebo.|||units on a scale||Standard Deviation|Mean
1294864|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores|The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.|||units on scale||95% Confidence Interval|Least Squares Mean
1294865|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores|The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.|||units on a scale||95% Confidence Interval|Least Squares Mean
1294866|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores|The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS|||units on a scale||95% Confidence Interval|Least Squares Mean
1294867|NCT00088634|Primary|Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score|The BPRS consists of 18 ordered categorical items (from “not present” to “extremely severe,” on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.|||units on a scale||95% Confidence Interval|Least Squares Mean
1294868|NCT00088621|Primary|Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study||1 year|Number of subjects that entered into the extension trial.|||participants|||Number
1294869|NCT00088595|Secondary|The Overall Safety and Tolerability of Pasireotide|Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight.|At least 15 days|The safety population consisted of all patients who received study drug (i.e. who started the pasireotide injections) and was thus identical to the Intent to treat (ITT) population.|||Participants|||Number
1294870|NCT00088595|Secondary|The Number of Patients (Participants) With Overall Tumor Response|The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively.|At least 15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.|||Participants|||Number
1295790|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1294871|NCT00088595|Secondary|Duration of Partial Symptom Control (Days) by Dose Class|Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval.|up to 15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= then number of patients with partial sympton control|||Days||Standard Deviation|Mean
1294872|NCT00088595|Secondary|Duration of Complete Symptom Control (Days) by Dose Class|Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied.|15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= the number of patients with complete symptom control.|||Days||Standard Deviation|Mean
1294873|NCT00088595|Primary|Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary|"Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied.~Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval.~Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level."|15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.|||participants|||Number
1294874|NCT00088530|Secondary|Overall Response Rate (ORR) Lasting at Least 4 Months|The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months.|approximately 24 months|Intent-To-Treat (ITT) population|||participants|||Number
1294875|NCT00088530|Secondary|Overall Survival|The time between the date of randomization and the date of death due to any cause.|18 months after 6 cycles of treatment; approximately 24 months|Intent-To-Treat (ITT) Population.|||Months||95% Confidence Interval|Median
1294876|NCT00088530|Secondary|Progression-Free Survival (PFS)|The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.|18 months after 6 cycles of treatment; approximately 24 months|Intent-to-treat patients|||months||95% Confidence Interval|Median
1294877|NCT00088530|Primary|Complete Response (CR) and Complete Response Unconfirmed (CRu)|Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)|EOT; approximately 6 months|Intent to Treat (all randomized patients)|||percentage of randomized patients||95% Confidence Interval|Number
1294878|NCT00088465|Primary|Number of Participants With Extrapyramidal Symptoms at Any Time|Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) >3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.|Randomization to end of study up to 76 months|Participants with a baseline and at least one post-baseline measurement.|||participants|||Number
1294879|NCT00088465|Primary|Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint|PCS weight gain is defined as a ≥7% increase in weight from baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
1294880|NCT00088465|Primary|Change From Baseline in Weight at Month 76 Endpoint|Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||kilogram (kg)||Standard Deviation|Mean
1294881|NCT00088465|Primary|Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline|Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides <150 mg/dL at baseline to ≥200 mg/dL and <500 mg/dL any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
1294882|NCT00088465|Primary|Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline|Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
1294883|NCT00088465|Primary|Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline|High ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of <5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of <2 times the ULN to ≥2 times the ULN at any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
1294884|NCT00088465|Primary|Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline|Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
1294885|NCT00088465|Secondary|Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year|Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).|Randomization to end of study up to 76 months|Participants who took at least one dose of study drug and had post-baseline measurements.|||(ng/mL)/(mg/day)||Standard Deviation|Mean
1294886|NCT00088465|Secondary|Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint|Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.|Randomization to end of study up to 76 months|All randomized participants.|||percent of participants|||Number
1294887|NCT00088465|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint|The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1294888|NCT00088465|Secondary|Days of Hospitalization|This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.|||days|||Number
1294889|NCT00088465|Secondary|Number of Psychiatric Visits|Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.|||visits|||Number
1294890|NCT00088465|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint|A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1294891|NCT00088465|Secondary|Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint|Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1294892|NCT00088465|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, up to 72 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Error|Mean
1294893|NCT00088465|Secondary|Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint|PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1294894|NCT00088465|Secondary|Change From Baseline in PANSS Negative Scores at Month 76 Endpoint|PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1294895|NCT00088465|Secondary|Change From Baseline in PANSS Positive Scores at Month 76 Endpoint|PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1294896|NCT00088465|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint|Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1294897|NCT00088465|Primary|Number of Participants With Adverse Events (AE)|The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.|||participants|||Number
1295874|NCT00075816|Secondary|Donor Recovery to Baseline Toxicity Scores||Measured at 1, 6, and 12 months|No data collected||||||
1294898|NCT00088374|Secondary|Number of Participants With Flow Dynamics Measured by DCE MRI Within the Renal and Non-renal Tumor|Dynamic images will be acquired before and after the intravenous administration of 0.1 mmol/kg of Gadolinium Diethylene triamine pentaacetic acid (DTPA). Time activity curves will be generated over a period of ten minutes. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters we had previously defined (Ktrans, Kep, etc.).|Baseline and during therapy (12 weeks)|It is not the magnitude of changes in Ktrans, Kep, and Ve that limit our abililty, but the fact that this data was available in only a small number of patients.|||participants with changes|||Number
1294899|NCT00088374|Secondary|Number of Patients in Whom Renal Tumors Could be Identified by Positron Emission Tomography (PET)Based on Fludeoxyglucose 18F (18FDG) Uptake|Images were acquired after the intravenous administration of 18FDG and H2015 and used to analyze glucose uptake and estimate blood flow. The parameter to be measured is SUV (standard uptake value(s)) and/or mL/min/gm.|Baseline and at 12 weeks|Response was not the endpoint. The SUV values were in the 2-3 range and hence renal tumors could not be clearly identified by this technique in any of the patients.|||participants|||Number
1294900|NCT00088374|Secondary|The Number of Participants With HIF, HSP90, and HSP70 Modulation in Resected Tumor Tissue and/or Peripheral Blood Lymphocytes|Measurement of HIF, HSP90 and HSP70 levels by Western Blot in tumor tissue and/or lymphocytes to assess modulation of these biomarkers in response to 17 AAG treatment. Pretreatment tumor samples (when available) and resected tumors (in those patients who did not have a response and underwent surgical resection of their tumor) were to be used for this analysis. Levels of Hsp90, Hsp70, HIF and HIF transcriptional targets in resected tumor will be compared to respective levels in tumors previously resected from other VHL patients (not treated with 17AAG).|Baseline and 12 weeks|This analysis was not performed as it was felt that there were not a sufficient number of samples to enable a meaningful analysis.||||||
1294901|NCT00088374|Secondary|The Number of Participants With Adverse Events|"Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.~The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting. For a detailed description see the link in the Protocol Link module."|1 yr, 364 days||||participants|||Number
1294902|NCT00088374|Secondary|Number of Participants With a Non-renal Tumor Response|Number of patients who have a PR or CR of non-renal lesions (pancreatic tumors, pheochromocytomas, and hemangioblastomas). The effect of treatment on the lesions will be evaluated at baseline and at the time of restaging (12 weeks) per RECIST criteria. RECIST is defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesions. Lesions are either measurable or non-measurable using the criteria. See the protocol Link module for the full criteria if desired.|Baseline and 12 weeks|There were only two patients with measurable nonrenal tumors and hence the number of participants analyzed is correct.|||participants|||Number
1294903|NCT00088374|Primary|Number of Participants With a Renal Tumor Response|Response is defined as the number of patients who experience a disease response (complete response (CR) or partial response (PR) of renal tumors)per RECIST criteria. CR is the disappearance of all target lesions. PR is at least a 20% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. See the protocol Link module for the full criteria if desired.|12 weeks|8 patients were evaluable (received at least one dose of drug and had a follow up scan).|||participants|||Number
1294904|NCT00088218|Primary|Number of Participants With Response|"Participant responses are categorized as 'Complete Remission,' Complete Remission, No Platelet Recovery,' 'No Response.'~Complete Remission: Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 109/L and platelet count > 100 x 109/L, and normal bone marrow differential (< 5% blasts); Complete Remission, No Platelet Recovery: Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 109/L.~Blood draws once a week until remission then every 2 to 8 weeks during therapy."|Every 2 to 8 weeks|All treated subjects.|||Participants|||Number
1294905|NCT00088166|Secondary|Number of Patients Who Discontinued Study Drug Prior to the End of Week 5|Numbers of patients who discontinued prior to the Week 5 assessment|Prospective|Intent to Treat population|||participants|||Number
1294906|NCT00088166|Secondary|Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study|The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16.|Prospective|Intent to Treat population; baseline observation carried forward|||Percent dexamethasone dose reduction||Standard Deviation|Mean
1294907|NCT00088166|Secondary|Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)|Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst).|Prospective||||Scores on a scale||Standard Deviation|Mean
1294908|NCT00088166|Secondary|Change From Baseline in the FACT-Br Quality of Life Results|The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL)|Prospective|Intent to Treat; LOCF|||Scores on a scale||Standard Deviation|Mean
1294922|NCT00087698|Primary|Pathological Complete Response|"Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy [EPP]).~Resected tissue or pleural fluid should be sent for pathological and histological evaluation."|Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)|All participants who had undergone surgery.|||participants|||Number
1295791|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1294909|NCT00088166|Secondary|Change From Baseline in the Karnofsky Performance Score|"Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is perfect health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows:~100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment nec"|Prospective|Intent to Treat population|||Scores on a scale||Standard Deviation|Mean
1294910|NCT00088166|Secondary|Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)|Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement.|Prospective|Intent to Treat population|||Scores on a scale||Standard Deviation|Mean
1294911|NCT00088166|Secondary|The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8|• The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8.|Prospective|Intent to Treat Population|||participants|||Number
1294912|NCT00088166|Secondary|Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS||Prospective|Intent to Treat Population|||participants|||Number
1294913|NCT00088166|Primary|The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5|"The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following:~50% or greater reduction in dexamethasone dose relative to Baseline~Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline~Karnofsky Score unchanged or increased relative to Baseline"|Prospective|Intent to Treat Population|||participants|||Number
1294914|NCT00088153|Primary|Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)|"Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months.~The other primary outcome was the change in spine bone density Z-score from baseline to 18 months. The bone density Z-score is a standard deviation score that compares one's bone density to the mean for age and gender, and the Z-score, therefore, does not have any units. It is simply referred to as a Z-score. Change in bone density Z-score= [Bone density Z-score at 18 months- Bone density Z-score at baseline]"|Baseline and 18 months||||Z -scores||Standard Deviation|Mean
1294915|NCT00088153|Secondary|Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)|"P1NP is a surrogate marker of bone formation that is measured in serum. P1NP levels were measured at baseline, 6, 12 and 18 months.~A secondary outcome was the change in P1NP levels from baseline to 18 months: [P1NP at 18 months - P1NP at baseline). The unit is ng/ml"|Baseline and 18 months|The number of participants was determined based on our preliminary data. This analysis was based on completers only.|||ng/ml||Standard Deviation|Mean
1294916|NCT00088153|Primary|Percent Change in Spine Bone Density Over the Study Duration (18 Months)|"Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months.~The primary outcome was the percent change in bone density at the spine from baseline to 18 months. Areal bone density is measured as g/cm2. The unit of measure for the percent change in bone density is 'percent' Percent change in bone density= [[Bone density at 18 months- Bone density at baseline)*100/Bone density at baseline]%"|Baseline and 18 months|The number of participants was determined using power calculations based on preliminary data. For our primary longitudinal analysis, bone mineral density (BMD) changes were analyzed using a mixed model analysis of variance (intent-to-treat model). For secondary analysis, we examined BMD changes after controlling for age and weight changes.|||Percent change||Standard Deviation|Mean
1294917|NCT00087698|Secondary|Overall Survival Time|Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).|baseline to date of death from any cause|All participants who had undergone surgery.|||months||Full Range|Mean
1294918|NCT00087698|Secondary|Time to Progressive Disease|Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.|baseline to measured progressive disease|All participants who had undergone surgery.|||months||Full Range|Mean
1294919|NCT00087698|Secondary|Time to Treatment Failure|Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.|baseline to stopping treatment|All participants who had undergone surgery.|||months||Full Range|Mean
1294920|NCT00087698|Secondary|Overall Tumor Response|The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.|baseline to measured progressive disease|Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.|||participants|||Number
1294921|NCT00087698|Secondary|The 1 and 2 Year Disease-Free Survival Rate (Percentage)|Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.|1 year and 2 years|All participants who had undergone surgery.|||percentage of participants||95% Confidence Interval|Mean
1294923|NCT00087685|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) is defined as the objective response rate plus the proportion of participants with prolonged stable disease (SD), e.g. nonprogression at 20 weeks. Objective response rate (ORR), determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST).|20 weeks|Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.|||percentage of participants||95% Confidence Interval|Number
1294924|NCT00087685|Primary|Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)|Response determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Stable Disease (SD): Any condition not meeting the above criteria. The minimum duration for the SD will be 8 weeks. If the participant has stable disease at the time of the first radiographic evaluation, he/she will be considered to have stable disease. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|8 weeks|Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.|||participants|||Number
1294925|NCT00087672|Primary|Efficacy of CC-5013 in Myelofibrosis|"Response evaluation, sustained for 2 weeks: Complete Remission (Neutrophil count between 1 to 10 x 10^9/L without peripheral blasts in blood or bone marrow); Partial Hematologic Response/Partial Remission (Increase in neutrophil by 50% + above 10^9/L for neutropenia); Hematologic Improvement (increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts) or No Response.~If nine or < patients respond to therapy (response other than 'No Response'), therapy declared ineffective. However, if 11 or > patients respond to therapy, therapy considered efficacious."|3 - 4 Months for all patients; 24 months for responders|Intention to treat: After a total of 41 patients were enrolled in study, nine or more patients responded to the therapy, therapy declared effective.|||Participants|||Number
1294926|NCT00087646|Secondary|Percentage of Participants With Relapse After End of Treatment|The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.|Week 96 (Group A and C) and Week 72 (Group B and D)|ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1294927|NCT00087646|Secondary|Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response|Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.|Week 96 (Group A and C) and Week 72 (Group B and D)|ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1294928|NCT00087646|Secondary|Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)|The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.|At Week 12 and 24|ITT population included all participants randomized who received at least one dose of study medication.|||IU/ML||95% Confidence Interval|Mean
1294929|NCT00087646|Secondary|Percentage of Participants With >=2log Drop in HCV-RNA|Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.|At Week 12 and 24|ITT population included all the participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1294930|NCT00087646|Secondary|Percentage of Participants With Undetectable HCV-RNA|"The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.~End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days)."|At Week 12, 24, 48 and EOT|ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1294931|NCT00087646|Secondary|Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)|SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|At Week 48 and Week 72|ITT population included all participants randomized who received at least one dose of study medication.|||participants|||Number
1294932|NCT00087646|Secondary|Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)|SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|At Week 48 and Week 72|ITT population included all participants randomized who received at least one dose of study medication.|||participants|||Number
1294933|NCT00087646|Primary|Number of Participants With Sustained Virological Response Rate|Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|Up to 72 weeks (Group A) and 48 weeks (Group D)|Intent-to-treat analysis population (ITT) included, all participants randomized who received at least one dose of study medication.|||participants|||Number
1294934|NCT00087633|Secondary|Summary of Virologic Response|Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment.|After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up|ITT population|||participants|||Number
1294935|NCT00087633|Primary|Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)|"Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2.~Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe.~Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis."|120 weeks postrandomization|Intent-to-treat population|||percentage of participants|||Number
1294936|NCT00087607|Secondary|Weekly AUC for IFN Concentrations for Pegasys and PEG-Intron Estimated by Population Pharmacokinetic Modeling|The estimation of weekly AUC for IFN concentrations for Pegasys and PEG-Intron was planned through population pharmacokinetic modeling. A population pharmacokinetic method deals with modelling in a cohort which has many participants (usually more than 40). The estimation of weekly AUC for IFN concentrations for Pegasys and PEG-Intron was planned to be studied in the population rather than the individuals in Peginterferon alfa-2a + Ribavirin and Peginterferon alfa-2b + Ribavirin groups.|Up to Week 8|The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). This outcome measure was not analyzed as no data were collected for any of the participants in this study.||||||
1294937|NCT00087607|Secondary|Percentage of Participants With Each of the Identified HCV Quasispecies at Baseline and Weeks 1, 4, 8, and 12|The determination of evolution of HCV quasispecies in participants was planned through analyzing viral sequences in serum samples drawn at baseline and at Weeks 1, 4, 8, and 12 if HCV RNA tests were positive and if the levels were sufficient to do the analysis.|Baseline, Weeks 1, 4,8, and 12|The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). This outcome measure was not analyzed as no data were collected for any of the participants in this study.||||||
1294938|NCT00087607|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).|||participants|||Number
1294939|NCT00087607|Secondary|Area Under the Curve for Interferon in the Frequent-Sampling Cohort|Area Under the Curve (AUC) for Interferon (IFN) for Week 1 and Week 8 in the frequent-sampling cohort were calculated using the trapezoidal rule.|Week 1 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants assessed for AUC for Interferon for specified time point.|||week*pg/mL||Standard Deviation|Mean
1294940|NCT00087607|Secondary|Mean Trough Interferon Concentrations at Each Week|The weekly Interferon (IFN) concentrations were calculated using the trapezoid rule. The trough IFN concentration was analyzed using an enzyme-linked immunosorbent assay (ELISA), with limits of quantification of 250 picograms per milliliter [pg/mL] for Pegasys and 150 pg/mL for PEG-Intron respectively.|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||pg/mL||Standard Error|Mean
1294941|NCT00087607|Secondary|Number of Participants With Marked Abnormalities in Thyroid Function Tests|Values outside the marked reference ranges for thyroid function test parameters that represent a defined, clinically relevant change from baseline are considered marked thyroid function test abnormalities. Roche’s standard reference ranges for thyroid function test parameters were used for the analysis. The thyroid function parameters with marked abnormalities were triiodothyronine (T3) (RR is 1.20 - 3.00 nanomole/liter [nmol/L]), thyroxine (T4) (RR is 51 – 154 nmol/L) and thyroid stimulating hormone (TSH) (RR is 0.0 - 5.0 milliunits per liter [mU/L]). Summary data of number of participants with only marked abnormalities in thyroid function tests are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).|||participants|||Number
1294949|NCT00087607|Secondary|The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week|The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The HCV AUC to Week 12 was the sum of the 12 weekly HCV AUCs divided by the time (12 weeks). Summary of weekly HCV AUC values estimated from the two adjacent pre-dose assessments are presented.|From Week -1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||log 10 IU/mL||Standard Deviation|Mean
1294942|NCT00087607|Secondary|Number of Participants With Marked Biochemical Test Abnormalities|Values outside the marked RR for biochemical test parameters that represent a defined, clinically relevant change from baseline are considered marked biochemical test abnormalities. Roche’s standard RR for biochemical parameters were used for this analysis. The biochemical test parameters with marked abnormalities were alanine aminotransferase (ALAT) (RR is 0 – 30 units per liter [U/L]), aspartate aminotransferase (ASAT) (RR is 0 – 25 U/L), gamma-glutamyl transferase (GGT) (RR is 0 – 60 U/L), total bilirubin (RR is 0 – 17 micromole/liter [umol/L]), creatinine (RR is 0 – 133 umol/L), total protein (RR is 60 – 80 g/L), triglycerides (RR is 0.45 - 1.70 millimole/liter [mmol/L]), chloride (RR is 100 – 108 mmol/L), potassium (RR is 3.5 - 5.0 mmol/L), sodium (RR is 133 – 145 mmol/L), calcium (RR is 2.10 - 2.60 mmol/L), random glucose (RR is 3.89 - 7.83 mmol/L), uric acid (140 – 500 umol/L). Summary data of number of participants with only marked biochemical test abnormalities are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).|||participants|||Number
1294943|NCT00087607|Secondary|Number of Participants With Marked Hematologic Abnormalities|The values outside the marked reference range for any hematology parameter that represents a defined, clinically relevant change from baseline are considered marked hematology abnormalities. The Roche standard reference ranges for the hematology parameters for which subjects had marked abnormalities were hematocrit [(RR) is 0.42 - 0.52 (fraction)], hemoglobin (RR is 13.0 - 18.0 gram/deciliter), platelets (RR is 150 – 450 10^9 cells/L), white blood cells (WBC) (RR is 4.3 - 10.8 10^9 cells/L), basophils (RR is 0.00 - 0.15 10^9 cells/L), lymphocytes (RR is 1.50 - 4.00 10^9 cells/L), monocytes (RR is 0.20 - 0.95 10^9 cells/L), neutrophils (RR is 1.83 - 7.25 10^9 cells/L), prothrombin time (PT) (RR is 9 – 13 seconds), partial thromboplastin time (Partial Throm.) (Time) (RR is 25.0 - 38.0 seconds) and PT International normalized ratio (INR) [RR is 0.70 - 1.30 (ratio)]. Summary data of number of participants with only marked hematology abnormalities are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).|||participants|||Number
1294944|NCT00087607|Secondary|Percentage of Participants With Undetectable HCV RNA (< 60 International Units/Milliliter) at Each Visit|The viral load was determined quantitatively and qualitatively by HCV-polymerase chain reaction (PCR). Qualitative viral titers will be assessed by Roche amplicor HCV Monitor® test v2.0 (< 600 IU/mL). The virological response was determined as the percentage of participants with undetectable HCV RNA at each week. A <60 IU/mL HCV-RNA was measured by amplicor PCR assay.|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).|||percentage of participants||95% Confidence Interval|Number
1294945|NCT00087607|Secondary|Percentage of Participants With a ≥ 2-log10 Decrease or Undetectable (< 60 International Units Per Milliliter) HCV RNA at Each Visit|The virological response was determined as the proportion/percentage of participants with a ≥ 2-log10 decrease or undetectable HCV RNA at each week. Detection of >= 2-log10 decrease of <60 IU/mL HCV-RNA was done by amplicor PCR assay at each week. Detection of >=2-log10 decrease or undetectable HCV RNA at Week 12 was considered an early virological response (EVR).|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).|||percentage of participants||95% Confidence Interval|Number
1294946|NCT00087607|Secondary|Weekly Viral Absolute Area Under the HCV RNA Curve Estimated in the Frequent-sampling Cohort for Weeks 1 and 8|The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. For the frequent-sampling cohort, HCV AUCs over 7 days were calculated for Weeks 1 and 8, with intervals calculated beginning at the dose after which the frequent sampling began (different from the 7-day calendar period used for other AUC calculations). The AUCs for Weeks 1 and 8 in the frequent-sampling cohort (Sparse samples [SS] and frequent samples [FS]) were calculated using the trapezoidal rule.|Week 1 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||log (IU*week/mL)||Standard Deviation|Mean
1294947|NCT00087607|Secondary|Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period|The area under the HCV-RNA curve (HCV AUC) was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week −1 HCV AUC (i.e., baseline) from the weekly HCV AUC. The HCV AUCMB to Week 12 was the sum of the 12 weekly HCV AUCMBs divided by the time (12 weeks).|Up to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).|||log10 IU/mL||Standard Deviation|Mean
1294948|NCT00087607|Secondary|Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12|The HCV AUC was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week −1 HCV AUC (i.e., baseline) from the weekly HCV AUC and presented.|Baseline, Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||log (IU*week/mL)||Standard Deviation|Mean
1295096|NCT00085839|Primary|Progression-free Survival|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|Until time of disease progression (maximum 5 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.|||months||95% Confidence Interval|Median
1294950|NCT00087607|Secondary|Weekly Viral Load Assessed at Drug Trough|The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The viral load levels in the serum at baseline and for each week, were expressed in terms of a logarithmic scale with base 10, and averaged for all participants.|Baseline, up to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||log (IU/mL)||Standard Deviation|Mean
1294951|NCT00087607|Secondary|Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8|The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to week 4 and week 8, expressed in terms of a logarithmic scale with base 10 are presented.|Baseline, Week 4 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).The “n” represents the number of participants analyzed at a specified time point.|||log (IU/mL)||Standard Error|Mean
1294952|NCT00087607|Primary|Change From Baseline in Viral Load (log10 Reduction) at Week 12|The viral load was determined quantitatively and qualitatively by Hepatitis C virus (HCV)-polymerase chain reaction (PCR). HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 international units per milliliter (U/mL), changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to Week 12, expressed in terms of a logarithmic scale with base 10, are presented.|From Baseline to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). Data using ITT Population are presented below.|||log (IU/mL)||Standard Error|Mean
1294953|NCT00087594|Secondary|Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Reason for discontinuation was categorized as safety and non-safety, where safety reasons included abnormality of laboratory tests, AEs, and death; and non-safety reasons included insufficient therapeutic response, early improvement, violation of selection criteria at entry, other protocol violation, refused treatment, failure to return and other. Participants who discontinued the study with any reason were recorded.|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
1294954|NCT00087594|Secondary|Number of Participants With Marked Laboratory Abnormalities (Biochemistry)|"Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data”, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal."|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
1294955|NCT00087594|Secondary|Number of Participants With Marked Laboratory Abnormalities (Hematology)|"Hematology included hematocrit (fraction), hemoglobin, platelets count, Red blood cells (RBC), White blood cell (WBC), eosinophils, lymphocytes, monocytes, neutrophils, Partial Thromboplastin time (PTT), Prothrombin Time International Normalized Ratio (PT INR). Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data”, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal."|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
1294956|NCT00087594|Secondary|Number of Participants With Abnormal Vital Signs|Vital Signs included systolic blood pressures (SBP), diastolic blood pressures (DBP), and pulse rate (PR). Abnormal vital signs were reported as low or high abnormal. It was defined as < 85 mm Hg or > 180 mm Hg with a change from baseline of > 20%; DBP as > 110 mm Hg with a change from baseline of > 20%; and PR as < 50 bpm and > 120 bpm with a change from baseline of > 20%.|Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
1295173|NCT00085410|Primary|Objective Response Rate|Objective Response Rate (ORR) was determined by best response on radiologic assessment (computed tomography or magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.|Up to 1 year|Per protocol|||Participants|||Count of Participants
1294957|NCT00087594|Secondary|Number of Participants With Compliance to the Prescribed Treatment Regimen|Participants with compliance to the prescribed treatment regimen for peginterferon alfa-2a and ribavirin was reported. Compliance was calculated as (total cumulative dose taken) / (total cumulative original dose prescribed for the entire study) x 100. Total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (48*7) for G1, total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (24*7) for G2/3.|Up to Week 24 for G 2/3; up to Week 48 for G1|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
1294958|NCT00087594|Secondary|Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit|The HQLQ is a multiple-choice questionnaire includes the eight individual qualify-of-life scales of the Medical Outcomes Study 36-item Short-form Health Survey as: Social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), general mental health (MH), physical functioning (PF), role limitations due to physical problems (RP), freedom from bodily pain (BP), and general health (GH). In addition, two other generic scales (positive well-being [PWB] and health distress [HD]) and two hepatitis-specific scales (limitations because of chronic hepatitis C [HLIM] and health distress because of chronic hepatitis C [HHD]) were included. Scores were scaled to a 0 to 100 range, with 0 = bad and 100 = good. A higher score indicates an improvement.|Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||units on a scale||Standard Error|Mean
1294959|NCT00087594|Secondary|Number of Participants With Degrees of Depression as Defined by the BDI-II Score|Participants with degrees of depression as defined by the BDI-II Score were reported. BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Up to Week 72|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
1294960|NCT00087594|Secondary|Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits|BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||units on a scale||Standard Error|Mean
1294961|NCT00087594|Secondary|Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)|BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||units on a scale||Standard Error|Mean
1294962|NCT00087594|Secondary|Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12||Week 12|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.|||participants|||Number
1294963|NCT00087594|Secondary|Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion|Biochemical response is defined as the number of participants with a normal serum alanine aminotransferase (ALT) concentration (i.e., ALT < 30 U/L). EOT for G1 was Week 48 and for G2/3 was Week 24.|Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.|||participants|||Number
1294964|NCT00087594|Secondary|Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion|Virological Response Rate is defined as the number of participants with undetectable HCV-RNA (< 10 IU/mL). Treatment completion (end of treatment [EOT]) for G1 was Week 48 and for G2 or 3 was Week 24.|Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.|||participants|||Number
1294965|NCT00087594|Secondary|Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)|SVR is defined as the number of participants with undetectable HCV-RNA (< 10 international unit per milliliter [IU/mL]) at 24 weeks post treatment completion.|Week 48 for G2/3 and Week 72 for G1|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.|||participants|||Number
1294966|NCT00087594|Primary|Number of Participants With Treatment Completion Rate (TCR)|TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or >= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a < 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment.|Up to 24 weeks for G2/3; up to 48 weeks for G1|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
1294967|NCT00087568|Secondary|Mean Score for Overall Local Injection Site Reaction|Local injection-site reactions were to be given an overall assessment based on pain or discomfort as Grade 0 for no pain or discomfort, Grade 1 for mild tenderness at the injection site, Grade 2 for moderate pain without limitation of usual activities, Grade 3 for severe pain requiring prescription non-topical analgesics or limiting usual activities, Grade 4 for a reaction that resulted in a new hospitalization, prolongation of hospitalization, death, or a persistent or significant disability/incapacity, or was life threatening or medically significant. Adverse events related to the injection site (injection site erythema, hematoma, pain, rash, or reaction) were reported. All of these events were reported as resolved without sequelae.|Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60|Safety Population included all enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.|||Units on a scale||Standard Deviation|Mean
1294968|NCT00087568|Secondary|Number of Participants With Abnormal Vital Signs|"Abnormal vital signs were defined as~Systolic blood pressure (BP) below 85 mm Hg or above 180 mm Hg with a change from baseline of > 20%~Diastolic BP above 110 mm Hg with a change from baseline of > 20% where systolic and diastolic BP were pressure exerted by blood on the walls of blood vessels during left ventricular systole and diastole respectively.~Pulse rate below 50 beats per minute and above 120 beats per minute, with a change from baseline of > 20%, where pulse represents the palpation of heartbeat"|From screening (Day -21 to Day -1) to Week 84|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).|||Participants|||Number
1294969|NCT00087568|Secondary|Number of Participants With Marked Laboratory Abnormalities|Analysis was performed for hematology, clinical chemistry, thyroid function, and urinalysis. Normal ranges of the parameters were: Haematocrit (fraction): 0.37 - 0.49, Haemoglobin (g/L): 130 - 180 , Platelets (G/L): 150 - 350, White blood cell (G/L): 4.5 - 11.0, Lymphocytes (G/L): 1.00 - 4.80, Neutrophils (G/L): 1.80 - 7.70, Prothrombin Time in Seconds (sec): not defined, Prothrombin Time, normalized (ratio): 0.70 - 1.30, Partial thromboplastin Time (sec): 22.1 - 34.1, Aspartate transaminase (AST) or serum glutamate oxaloacetate transaminase (SGOT) in IU/L: 0 - 40, Alkaline Phosphatase (IU/L): 0 - 115, ALT or serum glutamate pyruvate transaminase (SGPT) in (IU/L): 0-55, Total Bilirubin (umol/L): 0 -17, Thyroxine (T4) (nmol/L): 58 -140, Thyroid-stimulating hormone (TSH, [U/mL]): 0.0 - 5.0, Triglycerides (mmol/L): 0.45 - 1.69, Phosphate (mmol/L): 0.84 - 1.45, Uric Acid (umol/L): 214 - 506|Up to Week 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.|||participants|||Number
1294970|NCT00087568|Secondary|Number of Participants With Individual Flu-like Symptom|Participants were asked to complete a flu-like symptom questionnaire at screening, study baseline, and at all subsequent scheduled visits. The “yes/no” questionnaire evaluated the incidence of headache, fever, myalgia, and chills. If a participant answered “yes” to the question “Has the patient experienced any flu-like symptoms since the last visit?” all among headache, fever, muscle aches (myalgia), and chills that applied were to be marked. If any of the experienced symptoms was newly reported or had worsened, a corresponding adverse event was to be reported.|Baseline (Week 0); Weeks 12, 36, 60 and 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination data, BDI-II score, or FSS score). n = number of participants available at the particular time of assessment.|||Participants|||Number
1294971|NCT00087568|Secondary|Mean Score of Fatigue Severity Over Time|The Fatigue severity score (FSS) scale has a series of questions designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 or 4 weeks by marking on a visual analogue scale labelled at one end with “no fatigue” (‘0’ being the best) and at the other end with “greater fatigue” (‘100’ being the worst). Longer distance on the scale from “no fatigue” indicated “greater fatigue”. FSS values are presented based on questionnaire and visual analog scale.|Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, or FSS score). n = number of participants available at the particular time for assessment.|||Units on a scale||Standard Deviation|Mean
1294990|NCT00087490|Secondary|Duration of Intravenous Therapy for PP Population|Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|"PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.N(number of participants analyzed) = participants evaluable for the measure."|||Days||Standard Error|Mean
1294972|NCT00087568|Secondary|Mean Score of Beck Depression Inventory Over Time|The Beck Depression Inventory (BDI-II) is a questionnaire with groups of statements in which the patient is asked to select the statement that most clearly describes the way he/she has felt in the past two weeks, including today. The score for each group is tallied and the ranges of scores are used as guidelines for measuring the degree of depression. For this study, scores are defined as follows: 0 to 15 as minimal, 16 to 21 as mild, 22 to 30 as moderate, and 31 to 63 as severe. The questionnaire was in two areas (changes in sleeping pattern and changes in appetite), selections 1, 2, and 3 contained options for both more and less with respect to the area of interest. Four statements (labelled 0, 1, 2, and 3) were offered that described the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score.|Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84|Safety Population included all enrolled participants who received at least one dose of study drug and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score). n = number of participants available at the particular time for assessment.|||Units on a scale||Standard Deviation|Mean
1294973|NCT00087568|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An adverse event could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were also to be reported as adverse events. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 84|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).|||Participants|||Number
1294974|NCT00087568|Secondary|Number of Participants With Normal Serum Alanine Transaminase Levels Over Time|The number of participants with serum alanine transaminase (ALT) concentration within the normal range at each time point assessed. Upper limit of normal serum ALT for men is 43 International units per liter (IU/L) and for women is 34 IU/L.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84|ITT Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).|||Participants|||Number
1294975|NCT00087568|Secondary|Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time|Sustained virological response (SVR) is defined as undetectable Hepatitis C virus-ribonucleic acid (HCV RNA)(<60 International units per milliliter) or HCV RNA for >=2-log10 decrease in viral titre, 24 weeks after the end of treatment. A participant was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at Week 24 post or at any time between Week 24 and completion of antiviral treatment. HCV RNA measured prior to or on the date of the first dose of Pegasys plus ribavirin was used as the baseline in all HCV RNA analyses.|Weeks 4, 12, 24, 36, 48, 60, and 84|Intent to treat (ITT) Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).|||Participants|||Number
1294976|NCT00087568|Primary|Number of Pegasys and Ribavirin Therapy Completers|Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.|36 weeks for Non-Tolerators and 60 weeks for Non-Responders|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment which defined as clinical adverse event, laboratory or vital sign data, physical examination finding, Beck Depression Inventory (BDI-II), or Fatigue severity score (FSS).|||Participants|||Number
1294977|NCT00087555|Primary|The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).|"The percentage of participants who met all 3 of the following criteria:~Reduction of >=20% from baseline to week 8 in both PVAS & FIQ total score and PGI-C response of very much better or much better. Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from very much worse to very much better"|Baseline to week 8||||Percentage of Participants|||Number
1294978|NCT00087529|Secondary|Change From Baseline to Week 96 in Brain Volume on MRI Scan|Scheduled MRI scans of the brain and cervical spinal cord were performed with and without gadolinium contrast at Screening and Week 6, and without gadolinium at Weeks 48, 96, and 122 and/or upon early termination. The total brain volume was documented at Baseline and at visits occurring during Weeks 48 and 96. Missing Week 96 values were imputed using a LOCF approach, while participants with missing Baseline values were excluded. The change in brain volume was calculated as [volume at Week 96 minus volume at Baseline] and expressed in cubic centimeters (cm^3).|At Baseline and Week 96|ITT Population. Participants with missing Baseline values were excluded.|||cm^3||Full Range|Median
1295034|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage III or IV.|Up to 6 years|Full analysis set of participants with Rai Stage III or IV|||months||95% Confidence Interval|Median
1294979|NCT00087529|Secondary|Change From Baseline to Week 96 in Total Volume of Transverse Relaxation Time (T2) Brain Lesions on Magnetic Resonance Imaging (MRI) Scan|Scheduled T2-weighted MRI scans of the brain and cervical spinal cord were performed with and without gadolinium contrast at Screening and Week 6, and without gadolinium at Weeks 48, 96, and 122 and/or upon early termination. The total volume of T2 (ie, hyperintense) brain lesions at each visit was documented. Missing Week 96 values were imputed using a last observation carried forward (LOCF) approach, while participants with missing Baseline values were excluded. The change in T2 lesion volume was calculated as [volume at Week 96 minus volume at Baseline] and expressed in cubic millimeters (mm^3).|At Baseline and Week 96|ITT Population. Participants with missing Baseline values were excluded.|||mm^3||Full Range|Median
1294980|NCT00087529|Primary|Percentage of Participants With CDP|Disease progression was assessed using the EDSS, a disability scale that ranges from 0 to 10, where higher scores represent increased disability. Progression was defined as either an increase of ≥1 point from a Baseline EDSS score within 2.0 to 5.5 points, or an increase of ≥0.5 points from a Baseline EDSS score >5.5 points, for which the change was not attributable to another etiology. Repeat assessment to determine CDP must have occurred at a regularly scheduled visit at least 12 weeks after initial progression; those who discontinued treatment early without confirmatory EDSS assessment were considered as having CDP. The percentage of participants with CDP was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)|ITT Population.|||percentage of participants|||Number
1294981|NCT00087529|Primary|Time to Confirmed Disease Progression (CDP)|Disease progression was assessed using the Expanded Disability Status Scale (EDSS), a disability scale that ranges from 0 to 10, where higher scores represent increased disability. Progression was defined as either an increase of greater than or equal to (≥) 1 point from a Baseline EDSS score within 2.0 to 5.5 points, or an increase of ≥0.5 points from a Baseline EDSS score greater than (>) 5.5 points, for which the change was not attributable to another etiology. Repeat assessment to determine CDP must have occurred at a regularly scheduled visit at least 12 weeks after initial progression; those who discontinued treatment early without confirmatory EDSS assessment were considered as having CDP. Those who did not meet criteria for CDP, completed treatment with only initial progression, or received an exclusionary therapy were censored at last EDSS assessment. Time to CDP was the time from randomization to initial disease progression, estimated using Kaplan-Meier (KM) analysis.|96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)|ITT Population.|||weeks||95% Confidence Interval|Median
1294982|NCT00087516|Secondary|Change From Baseline in 2-hr PMG at Week 104|Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.|Weeks 0-104|The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1294983|NCT00087516|Secondary|Change From Baseline in FPG at Week 104|Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.|Weeks 0-104|The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1294984|NCT00087516|Secondary|Change From Baseline in A1C at Week 104|A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.|Weeks 0-104|The all-patients-treated population for Week 104 included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||Percent||95% Confidence Interval|Least Squares Mean
1294985|NCT00087516|Secondary|Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1294986|NCT00087516|Secondary|Change From Baseline in FPG at Week 24|Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||mg/dL||95% Confidence Interval|Least Squares Mean
1294987|NCT00087516|Primary|Change From Baseline in A1C at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||Percent||95% Confidence Interval|Least Squares Mean
1294988|NCT00087490|Secondary|Number of Participants Using Medical Resources|Medical resources utilization included a daily log of the participants’ location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|Data was not analyzed for the primary reporting.|||Participants|||Number
1294989|NCT00087490|Secondary|Duration of Intravenous Therapy for mITT Population|Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. N(number of participants analyzed)=participants evaluable for the measure."|||Days||Standard Error|Mean
1294991|NCT00087490|Secondary|Duration of Hospital Stay for mITT Population|Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.|||Days||Standard Error|Mean
1294992|NCT00087490|Secondary|Duration of Hospital Stay for PP Population|Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.|||Days||Standard Error|Mean
1294993|NCT00087490|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; “0= none, 1= mild, 2= moderate and 3= severe”.|EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)|mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. Here, 'n' signified participants who were evaluable and analyzed for specific clinical signs and symptoms.|||Partcipants|||Number
1294994|NCT00087490|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; “0= none, 1= mild, 2= moderate and 3= severe”.|EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)|PP set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen, satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days),observed outcome at EOS visit unless declared failure prior to the visit.Here,'n'=participants evaluable for specific clinical signs and symptoms.|||Participants|||Number
1294995|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).|EOT (within 72 hours of last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."|||Percentage of participants|||Number
1294996|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).|EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."|||Percentage of participants|||Number
1294997|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).|EOT (within 72 hours of last dose of study drug)|"PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."|||Percentage of participants|||Number
1294998|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).|EOS (6 to 28 days after the last dose of study drug)|"PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."|||Percentage of participants|||Number
1294999|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population|CR evaluated at EOT visit as “success” (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown”: excluded from present analysis.|EOT (within 72 hours of last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."|||Percentage of participants|||Number
1295000|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population|CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as “success” (cure: resolution of clinical signs/symptoms of infection when compared to baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown” was excluded from present analysis.|EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."|||Percentage of participants|||Number
1295001|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population|CR evaluated at EOT visit as “success” (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown”: excluded from present analysis.|EOT (within 72 hours of last dose of study drug)|"PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."|||Percentage of participants|||Number
1295002|NCT00087490|Primary|Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population|Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as “success” (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown” was excluded from present analysis.|EOS (6 to 28 days after the last dose of study drug)|"PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."|||Percentage of participants|||Number
1295003|NCT00087438|Secondary|Rates of Local Recurrence, Regional Recurrence, Disseminated Recurrence, Disease-free and Overall Survival at 2 Years||From the start of treatment to 2 years|||||||
1295004|NCT00087438|Secondary|Treatment-related Grade 3 or 4 Toxicity||From the start of treatment to end of follow-up|||||||
1295005|NCT00087438|Primary|Local Control at 2 Years|Local control is defined as absence of local failure. (Detailed criteria for local failure is too long to include here.)|From the start of treatment to 2 years|Eligible patients who started protocol treatment.|||percentage of subjects||95% Confidence Interval|Number
1295006|NCT00087152|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Every 3 weeks while on treatment for up to 3 years.|Eligible participants who received any treatment.|||Participants|||Number
1295007|NCT00087152|Secondary|Progression-free Survival at 6 Months|Percentage of participants progression-free at 6 months. Progression-free survival (PFS) measured from date of registration to first observation of progressive disease (per RECIST criteria (V1.0)), death due to any cause, or symptomatic deterioration. Kaplan-Meier was used to estimate progression-free survival (PFS) at six months.|Six months|Eligible participants who received treatment.|||percentage of participants||95% Confidence Interval|Number
1295008|NCT00087152|Primary|Confirmed Response Rate (Complete and Partial)|Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.|12 weeks|Eligible participants who received treatment.|||participants|||Number
1295009|NCT00087139|Secondary|Duration of Measurable Disease Response|Duration of measurable disease response was defined as the time from the date when measurement criteria were met for complete or partial response, whichever status was recorded first, until the first date that recurrent or progressive disease was objectively documented based on RECIST (Response Evaluation Criteria in Solid Tumors). Only patients with measurable disease response were included in this analysis.|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|Only patients with measurable disease response were included in this analysis.|||Months||95% Confidence Interval|Median
1295010|NCT00087139|Secondary|Duration of PSA Response|Duration of PSA response was defined as the time from the date of onset of PSA response until the date the criteria were met for PSA progression. Only patients with a PSA response were included in this analysis. The results were reported separately for 3 strata.|Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response related analysis was only done among the first cohort of patients, not including the additional patients with measurable disease.|||Months||95% Confidence Interval|Median
1295011|NCT00087139|Secondary|Proportion of Patients With Measurable Disease Response (Best Overall Response)|"Only patients with measurable disease were included in this analysis. The proportion of patients with measurable disease response (based on RECIST: Response Evaluation Criteria in Solid Tumors) was reported separately for 3 strata.~Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|Only patients with measurable disease were included in this analysis.|||proportion of participants||90% Confidence Interval|Number
1295012|NCT00087139|Primary|Proportion of Patients With PSA Response|PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.|Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response rate was only calculated among the first cohort of patients, not including the additional patients with measurable disease.|||Proportion of participants||90% Confidence Interval|Number
1295013|NCT00087022|Post-Hoc|Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6|"This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6.~The CAIX score is determined on the basis of CAIX expression via immunohistochemistry described by a combination of tumor cell extent and staining intensity.~Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy."|Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)|This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6.|||Participants|||Count of Participants
1295014|NCT00087022|Secondary|Pharmacokinetics of WX-G250|Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).|Week 8|Patients who did sign amendment #3 to the study protocol and received their cG250 infusion as scheduled in the study protocol|||µg/mL||Standard Deviation|Mean
1295015|NCT00087022|Secondary|Quality of Life - Global Health Status|Quality of life by EORTC Quality of Life Questionnaire-C30 - Global Health Status at 12 months. A high score for the global health status/QoL represents a high QoL with 0 being the minimum and 100 being the maximum.|At 12 months|Patients still on study who completed the questionnaire|||score on a scale||Standard Deviation|Mean
1295016|NCT00087022|Primary|Overall Survival|Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.|After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later (median follow-up of 4.5 years)|All patients that were enrolled were included in the ITT population used for efficacy analysis|||Participants|||Count of Participants
1295017|NCT00087022|Primary|Disease-free Survival|Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.|Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)|All patients that were enrolled were included in the ITT population used for efficacy analysis|||Participants|||Count of Participants
1295018|NCT00086996|Secondary|Progression-free Survival|measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.|0-3 years|eligible patients|||months||95% Confidence Interval|Median
1295019|NCT00086996|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|0-5 years|eligible patients|||months||95% Confidence Interval|Median
1295020|NCT00086996|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any Common Terminology Criteria for Adverse Events (CTCAE) v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1295021|NCT00086996|Primary|Pathological Complete Response|Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.|10-16 weeks after beginning study treatment|Eligible patients|||participants|||Number
1295022|NCT00086957|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).|||Months||95% Confidence Interval|Median
1295035|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage I or II.|Up to 6 years|Full analysis set of participants with Rai Stage I or II|||months||95% Confidence Interval|Median
1295023|NCT00086957|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR.|After 3 cycles of treatment, up to 2 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion). Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.|||percentage of participants|||Number
1295024|NCT00086957|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|Until disease progression, up to 5 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).|||Months||95% Confidence Interval|Median
1295025|NCT00086957|Primary|Recommended Phase II Dose|The maximum tolerated dose (MTD): subjects received gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks. This was to serve as the phase II dose if no dose-limiting toxicities (DLTs) occurred in the first three subjects. If one DLT occurred in the first three subjects, another three subjects where to be enrolled at this dose, whereas if two DLTs occurred in the first three subjects, the docetaxel dose was to be decreased to 60 mg/m^2. The study would then be continued only if no more than one patient had a DLT at this dose. Once the dose of docetaxel was established, all further subjects were to be treated at the phase II MTD dose.|4 weeks from start of treatment, up to 2 years|All patients observed for 21 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg/m^2|||Number
1295026|NCT00086957|Primary|Number of Participants With at Least One Dose Limiting Toxicity in Phase I|Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.|||participants with DLTs|||Number
1295027|NCT00086684|Secondary|Number of Responders Defined as Having at Least a Four Point Reduction in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint|The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.|Baseline to Week 24|Intent-to-Treat (ITT) Analysis set|||participants|||Number
1295028|NCT00086684|Primary|Number of Responders Defined as Having at Least a 30% Reduction in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint|The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.|Baseline to Week 24|Intent-to-Treat (ITT) Analysis set|||participants|||Number
1295029|NCT00086619|Secondary|Change in Bone Mineral Density (BMD)|Percent change in BMD of the spine, femur, radius, and ulna, and subtotal body, calculated as 100*[(final - month 0)/month 0] in subjects who took study therapy for at least 12 months.|baseline and 18 months (12 months in 4 subjects)|Final BMD was measured after 18 months of study therapy in 48 subjects and measured after 12 months of study therapy in 4 others who thereafter dropped out prematurely. Of the latter 4, 3 were in the ascending dose arm and 1 was in the constant dose arm.|||percent change||Standard Deviation|Mean
1295030|NCT00086619|Primary|Changes in Indices of Bone Turnover|Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months*ng/ml) for the marker.|Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.|Because this was a physiologic study evaluating the impact of stepwise increases in teriparatide, per protocol analysis was performed as was pre-specified in our analysis plan. Outcomes data were analyzed in women who remained on teriparatide throughout the first stepwise increase (i.e. until month 12 or later).|||months*(ng/ml - baseline ng/ml)||Standard Deviation|Mean
1295031|NCT00086580|Secondary|Participants With Minimal Residual Disease (MRD)|MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a clinical complete response (CR) or partial response (PR) without recovery of blood counts. MRD represents a very positive outcome.|up to 9 months|Full analysis set|||participants|||Number
1295032|NCT00086580|Secondary|Maximum Plasma Concentration (Cmax) of Fludarabine|Cmax is the maximum plasma concentration of fludarabine observed.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
1295033|NCT00086580|Secondary|Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)|AUC (0-tau) is the area under the plasma concentration curve for fludarabine over the dosage interval (tau).|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population|||ng*h/mL||Standard Deviation|Mean
1295875|NCT00075816|Secondary|Donor Recovery of Baseline Complete Blood Count (CBC) and White Blood Cell Count (WBC) Differential||Measured at 1, 6, and 12 months|No data collected||||||
1295036|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage III or IV.|Up to 6 years|Full analysis set of participants with Rai stage III or IV|||months||95% Confidence Interval|Median
1295037|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage I or II.|Up to 6 years|Full analysis set of participants with Rai stage I or II|||months||95% Confidence Interval|Median
1295038|NCT00086580|Secondary|Total Volume of Distribution (Vss) of Fludarabine|The total volume of distribution (Vss) is the apparent volume in which fludarabine is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Total volume of distribution (Vss) of fludarabine is derived from plasma concentration versus time data.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population|||liters||Standard Deviation|Mean
1295039|NCT00086580|Secondary|Mean Systemic Clearance (CL) of Fludarabine|Clearance of drug from plasma is affected by the absorption, distribution, metabolism and elimination of the drug. Mean systemic clearance of fludarabine is derived from plasma concentration versus time data.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population|||liters/hour||Standard Deviation|Mean
1295040|NCT00086580|Secondary|Summary of Participants With Adverse Experiences (AEs)|Number of participants with adverse events (AEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (4 point scale from 'not related' to 'definitely related'). Categories reported include participant counts for treatment-emergent AEs, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), and deaths. Related AEs for the combination arm can be related to either fludarabine or alemtuzumab.|Up to 6 years|Safety population|||participants|||Number
1295041|NCT00086580|Secondary|Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment|"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom."|up to month 6 (end of treatment)|Full analysis set. Participants who provided valid answers on questionnaires are included.|||units on a scale||Standard Deviation|Mean
1295042|NCT00086580|Secondary|Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline|"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom."|Day 0 (baseline)|Full analysis set. Participants who provided valid answers on questionnaires are included.|||units on a scale||Standard Deviation|Mean
1295043|NCT00086580|Secondary|Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment|EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).|up to month 6 (end of treatment)|Full analysis dataset. Participants who provided valid answers on questionnaires are included.|||units on a scale||Standard Deviation|Mean
1295044|NCT00086580|Secondary|Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline|EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).|Day 0 (baseline)|Full analysis dataset. Participants who provided valid answers on questionnaires are included.|||units on a scale||Standard Deviation|Mean
1295045|NCT00086580|Secondary|Kaplan-Meier Estimates for Time to Alternative Therapy|Time to alternative therapy was defined as the number of days from the date of randomization to the date of first alternative therapy for chronic lymphocytic leukemia (CLL) or death resulting from any cause. Participants who had not received alternative therapy as of the data cutoff date were censored at the last follow-up visit assessment date plus 1 day. Results are stated in months.|Up to 6 years|Full analysis set|||months||95% Confidence Interval|Median
1295046|NCT00086580|Secondary|Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)|Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease as determined by IRRP or death due to any cause. Results are stated in months.|Up to 6 years|Full analysis set of participants who achieved a complete response or a partial response as determined by the IRRP.|||months||95% Confidence Interval|Median
1295047|NCT00086580|Secondary|Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)|Time to disease progression was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease as determined by IRRP. Results are stated in months.|Up to 6 years|Full analysis set|||months||95% Confidence Interval|Median
1295048|NCT00086580|Secondary|Kaplan-Meier Estimates of Overall Survival Time|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months.|Up to 6 years|Full analysis set|||months||95% Confidence Interval|Median
1295049|NCT00086580|Secondary|Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.|Up to 9 months|Full analysis set|||participants|||Number
1295050|NCT00086580|Primary|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months.|Up to 6 years|Full analysis set|||months||95% Confidence Interval|Median
1295051|NCT00086411|Secondary|Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.||52 weeks|||||||
1295052|NCT00086411|Primary|Percent Treatment Sessions Attended|"Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.~A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.~Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing."|52 weeks||||Percentage of attended tx. sessions||Standard Error|Mean
1295053|NCT00086385|Primary|Participants Abstinent From Cigarettes|Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104|Two years||||participants|||Number
1295054|NCT00086515|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1295055|NCT00086515|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|"Change from baseline at Week 24 is defined as FPG at~Week 24 minus FPG at Week 0."|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1295056|NCT00086515|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|"A1C is measured as a percent. Thus, this change from~baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent."|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
1295057|NCT00086502|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
1295058|NCT00086502|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
1295059|NCT00086450|Secondary|Rates of Individual MACCE Endpoints|Major adverse cardiovascular and cerebrovascular events|Measured at Day 30||||percentage of participants|||Number
1295060|NCT00086450|Secondary|All-cause Mortality||Measured at Year 5||||percentage of participants|||Number
1295061|NCT00086450|Secondary|Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization||Measured at Year 1||||percentage of participants|||Number
1295062|NCT00086450|Primary|5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke|median 3.8 years of follow-up|Measured at Year 5||||percentage of participants|||Number
1295063|NCT00086346|Primary|Patient and Graft Survival|Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.|12 months|Intent to treat analysis population with stratification by antimetabolite therapy and hepatitis C status.|||patients|||Number
1295064|NCT00086346|Secondary|Mean Serum Creatinine|Observed mean values for serum creatinine.|12 months|On-therapy population; consisted of patients who were still receiving study medication at the defined endpoint.|||µmol/L||Standard Deviation|Mean
1295065|NCT00086346|Secondary|Number of Patients With a Biopsy Confirmed Acute Rejection|Overall event rate is determined as yes or no.|12 months|The analysis population is the intent to treat. Any patient whose clinical rejection data was incomplete was designated as an acute rejection in the analysis.|||patients|||Number
1295876|NCT00075816|Secondary|Immune Reconstitution||Measured at 100 days, 6 months, and 1 and 2 years|No data collected||||||
1295066|NCT00086346|Primary|Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.|Baseline and 12 months|The intent to treat population was analyzed and consisted of all patients randomly assigned to treatment. Patients were stratified by hepatitis C status and whether or not they were receiving antimetabolite therapy at time of randomization.|||mL/min||Standard Error|Mean
1295067|NCT00086281|Primary|The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).|The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting >= 10 seconds, accompanied by oxygen desaturation of >3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting >= 10 seconds, with clear decrease (>50%) from baseline in the amplitude of breathing or a decrease <50% in the amplitude of breathing accompanied by oxygen desaturation of >3% or arousal.|One night of PSG during one night of treatment each per arm.||||Apnea + Hypopnea episodes per hour||Standard Deviation|Mean
1295068|NCT00086307|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.|Weekly|All patients with at least one post-baseline measurement were included in the analysis.|||Score on a scale||Standard Error|Least Squares Mean
1295069|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Mental Health|Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in SF-36 Mental Health score||Standard Error|Mean
1295070|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Role-Emotional|Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in SF-36 Role score||Standard Error|Mean
1295071|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Vitality|Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in SF-36 vitality score||Standard Error|Mean
1295072|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Mental Component Summary|Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in SF-36 mental score||Standard Error|Mean
1295073|NCT00086190|Secondary|Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being|Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in PDQ-39 Emotional score||Standard Error|Mean
1295074|NCT00086190|Secondary|Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall|Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in PDQ-39 score||Standard Error|Mean
1295075|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar|Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in UPDRS-Bulbar score||Standard Error|Mean
1295076|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor|Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in UPDRS-tremor score||Standard Error|Mean
1295077|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor|Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in UPDRS-motor score||Standard Error|Mean
1295078|NCT00086190|Secondary|Change in Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in PQSI score||Standard Error|Mean
1295079|NCT00086190|Secondary|Change in Snaith Clinical Anxiety Scale (CAS)|Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in CAS score||Standard Error|Mean
1295080|NCT00086190|Secondary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS)|Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in UPDRS score||Standard Error|Mean
1295081|NCT00086190|Secondary|Change in Brief Psychiatric Rating Scale (BPRS)|Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in BPRS score||Standard Error|Mean
1295082|NCT00086190|Secondary|Change in Geriatric Depression Rating Scale (GDS)|Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in GDS score||Standard Error|Mean
1295083|NCT00086190|Secondary|Change in Beck Depression Inventory II (BDI-II)|Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in BDI-II score||Standard Error|Mean
1295084|NCT00086190|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in MADRS score||Standard Error|Mean
1295085|NCT00086190|Primary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in HAM-D score||Standard Deviation|Mean
1295086|NCT00086138|Secondary|Remission According to Cornell Scale for Depression in Dementia Scale|The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12.|Measured at Weeks 12||||percentage of participants|||Number
1295087|NCT00086138|Primary|Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)|At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer’s Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 (“much better”) to 7 (“much worse”), with a score of 4 being “no change”.|Measured at Week 12||||participants|||Number
1295088|NCT00086047|Secondary|Depressive Symptoms||9 weeks and 6 months|||||||
1295089|NCT00086047|Secondary|Pain Intensity||9 weeks and 6 months|||||||
1295090|NCT00086047|Primary|Change in FDI (Functional Disability Inventory) Scores at End of Study|Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)|Baseline and 6 months (end of study)|Intent to treat analysis|||units on a 0-60 scale||95% Confidence Interval|Mean
1295091|NCT00085917|Secondary|Number of Participants With Adverse Events|"Adverse Events~- Anemia, Neutropenia and Psychiatric adverse events"|48 weeks||||participants|||Number
1295092|NCT00085917|Secondary|Number of Participants With Normalization of Liver Enzymes|normalization of liver enzymes :Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) Alanine aminotransferase (ALT): Normal 6 - 41 U/L Aspartate aminotransferase (AST) : Normal 9 - 34 U/L|week 24, week 48, week 72||||participants|||Number
1295093|NCT00085917|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR [ Sustained virological response] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.|72 weeks||||participants|||Number
1295094|NCT00085839|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.|While receiving study treatment (maximum 60 weeks)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.|||participants|||Number
1295097|NCT00085735|Secondary|Compliance Rates for All Eligible and Evaluable Patients Enrolled|A patient will be considered to be compliant if the patient/parent participated in the PedsQLTM v4 and the ABAS assessment. The patient should have a PedsQL total score which measures quality of life and a general adaptive composite (GAC) score which measures adaptive functioning. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time points. All eligible and evaluable patients enrolled on ACNS0331 will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.|Up to 6 years post-diagnosis|||||||
1295098|NCT00085735|Secondary|Time to Recurrence, Progression or Death Due to Cancer / Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays|Time from study entry to disease progression, relapse or death due to cancer or to last follow-up. Deaths from causes that are clearly not associated with tumor recurrence or progression and second malignancies will be censored. Three-year PFS rates will be reported by methylation subgroup. Randomized eligible and evaluable patients (patients without disease dissemination or excess residual disease by central review and patients without anaplastic histology) will be included.|Assessed at 3 years|||||||
1295099|NCT00085735|Secondary|Time to Death From Any Cause / Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays|Three-year survival rates will be reported by methylation subgroup. Randomized eligible and evaluable patients (patients without disease dissemination or excess residual disease by central review and patients without anaplastic histology) will be included.|Assessed at 3 years|||||||
1295100|NCT00085735|Secondary|Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Test at the Completion of Therapy.|Incidence rates of abnormal growth hormone stimulation tests at the after completion of therapy assessment will be reported separately for eligible and evaluable IFRT and PFRT patients.|After completion of therapy, an average of 2 years|||||||
1295101|NCT00085735|Secondary|Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE Version 4|Proportions of pts with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.|1 year after end of treatment|Eligible & evaluable pts were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable(NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 eligible/evaluable pts. However some pts (28/22) weren't followed for at least 1-yr post-off tx (e.g., withdrew consent for FU or died), leaving 199 IFRT/215 PFRT pts.|||Percentage of pts with g3+ hearing loss|||Number
1295102|NCT00085735|Secondary|Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) and Also the Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF)|Average scores for FSIQ and MI will be reported at each of the 3 neurocognitive assessment time points by LDCSI vs. SDCSI groups. All eligible and evaluable patients 3-7 years of age will be used.|Up to 6 years post-diagnosis|||||||
1295103|NCT00085735|Secondary|Post-treatment Grade 3+ Hearing Loss as Measured by CTCAE v4|Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for LDCSI vs. SDCSI patients. Eligible and evaluable patients 3-7 years of age will be used.|Up to 1 year after the end of treatment|Only eligible & evaluable pts 3-7 years of age are included since only younger pts were randomized to either LD or SD CSI. 11 and 8 LDCSI and SDCSI pts respectively were not evaluable due to anaplastic disease or excess residual/disseminated disease, leaving 116 vs 110 patients for this analysis.|||Percentage of pts with g3+ hearing loss|||Number
1295104|NCT00085735|Secondary|Post-treatment Endocrine Function (Growth Hormone (GH) and Thyroid Stimulating Hormone (TSH) as Measured by Laboratory Assessment)|Growth hormone stimulation tests were performed and noted as normal or abnormal at baseline and after completion of therapy/follow-up. Proportions of patients with abnormal results after completion of therapy will be calculated and reported separately for LDCSI vs. SDCSI patients. Mean post-treatment TSH levels will be reported by CSI group. Eligible and evaluable patients 3-7 years of age will be used.|Up to 3 years|||||||
1295105|NCT00085735|Secondary|Non-posterior Fossa (NPF) Failure Rate|NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.|||Percentage of 3 yr cumulative incidence||95% Confidence Interval|Number
1295106|NCT00085735|Secondary|Non-local Posterior Fossa (NLPF) Failure Rate|NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.|||Percentage of 3 yr cumulative incidence||95% Confidence Interval|Number
1295107|NCT00085735|Secondary|Local Posterior Fossa (LPF) Failure Rate|LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.|||percentage 3 yr cumulative incidence||95% Confidence Interval|Number
1295108|NCT00085735|Secondary|Overall Survival (OS)|OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V [IFRT] are combined and compared to arms II, IV and VI [PFRT].|3 years|Per protocol only eligible & evaluable pts were included.Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.|||Probability of 3 yr OS rate||95% Confidence Interval|Number
1295109|NCT00085735|Primary|Event-free Survival (EFS)|EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.|3 years|Per protocol only eligible & evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.|||probability of 3 year EFS||95% Confidence Interval|Number
1295110|NCT00085709|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.|Eligible patients who started therapy|||Participants with a given type of AE|||Number
1295111|NCT00085709|Primary|Complete Remission||After induction therapy was completed (1 or 2 months)|Eligible patients who did not withdraw consent|||participants|||Number
1295112|NCT00085709|Primary|2-year Disease-free Survival (DFS)|Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.|After completing any treatment, every 6 months for 2 years, than annually for years 3-5|Eligible patients who completed induction and consolidation therapy|||Percentage of population||95% Confidence Interval|Number
1295113|NCT00085644|Secondary|Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure|"Completed by subject at each visit. The Patient Acceptable Symptoms State (PASS) was a participant-reported outcome where participants were expected to respond (yes/no) to the following question:~Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?"|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295114|NCT00085644|Secondary|Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure|ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are participants with a minimal clinically important difference (MCID) <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295115|NCT00085644|Secondary|Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure|"ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295116|NCT00085644|Secondary|Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure|The HUI-3 is a generic approach to the measurement of health status and assessment of health-related quality of life (HRQL). The HUI-3 classification is comprised of a total score and 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. The attributes are measures on a scale from the worst score of 0 to best score of 1. The total score scale ranges from dead (= 0) and perfect health (= 1). The total score can have a negative score that is interpreted as worse than dead and the lower limit is –0.36. An increase in the HUI-3 score represents improvement.|Baseline, Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295174|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level.These Secondary Endpoints Would Only Have Been Assessed if a Patient Had Met the Primary Endpoint, Restoration of Radioiodine Uptake to Justify Radioiodine Therapy.||3 months|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
1295117|NCT00085644|Secondary|Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning).~Responders were subjects whose change in MCS fulfilled the Minimal Clinically Important Difference (MCID). The MCID for MCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295118|NCT00085644|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295119|NCT00085644|Secondary|Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning).~Responders were subjects whose change in PCS score fulfilled the Minimal Clinically Important Difference (MCID). The MCID for PCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295120|NCT00085644|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295121|NCT00085644|Secondary|Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260|The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1295122|NCT00085644|Secondary|Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|The physician will globally assess the subject's current disease state using a 100-mm VAS scale with 0 being very good and 100 being very bad.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1295123|NCT00085644|Secondary|Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260|"Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Hip, Knee, Ankle, and Metatarsophalangeal (1-5)."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295175|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level||6 months|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
1295124|NCT00085644|Secondary|Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260|"Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295125|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260|BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295126|NCT00085644|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 to 13 (minimum to maximum number and severity of enthesitis).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295127|NCT00085644|Secondary|Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [|"The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE.~An increase in chest expansion represents improvement"|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
1295128|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
1295129|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured by ASAS Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260|ASAS partial remission was calculated as follows: A value below 20 on a 0 - 100 point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function, and Inflammation). Partial remission is also regarded as a low disease activity state.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295130|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260|"The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage.~ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP])."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295187|NCT00085202|Secondary|Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa|To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.|Annually for 6 years post irradiation|||||||
1295217|NCT00084838|Other Pre-specified|Grade 3/4 Events|All Grade 3-4 events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295131|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure|ASAS 40 responders - improvement of >=40% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of any deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295132|NCT00085644|Secondary|Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation. A decrease in CRP indicates improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mg/dL||Standard Deviation|Mean
1295133|NCT00085644|Secondary|Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260|The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
1295134|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295135|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295136|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295188|NCT00085202|Secondary|Reading Decoding Composite Scores in the Intervention and Standard of Care Groups|To compare the effects of a computer-based training system specifically targeting language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation) with the current standard of care on reading decoding skills as measured by individual academic testing.|Measurements will be made at time of randomization, at 3 months from initiation of treatment, and yearly thereafter for 10 years|||||||
1295235|NCT00084409|Other Pre-specified|Define the Genes Whose Expression is Altered by Iloprost Treatment by Gene Expression Arrays and Quantitative PCR.||Nine Years|||||||
1295236|NCT00084409|Other Pre-specified|To Determine the Toxicity Profile of Iloprost in Patients at High Risk to Develop Lung Cancer.||Nine Years|||||||
1295137|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure|"The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement.~A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe]."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295138|NCT00085644|Secondary|Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260|The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
1295139|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|Participants assessed disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain). A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295140|NCT00085644|Secondary|Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1295141|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295142|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260|BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 100-mm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 100 (impossible).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1295143|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295144|NCT00085644|Secondary|Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
1295145|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 70 - Through Week 260 of Adalimumab Exposure|ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]), Total Back Pain VAS; (0 [no pain] - 100 [severe]), BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as defined as a worsening of >= 20% and a net worsening of >= 10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295146|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 50 - Through Week 260 of Adalimumab Exposure|ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295147|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS (0 [none] to 10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
1295148|NCT00085644|Primary|Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score|Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 [no change] to 72 [progression]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.|Week 104|The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.|||score on a scale||Standard Error|Mean
1295149|NCT00085644|Primary|Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none]-100 [severe]), Total Back Pain VAS (0 [no pain]-100 [severe]), BASFI VAS (0 [easy]-100[impossible]); and Inflammation VAS (0 [none]-10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Week 12||||Participants (responders, nonresponders)|||Number
1295150|NCT00085631|Primary|Five-Year Overall Survival|Five-year overall survival (OS) time was time from date of randomization until death from any cause. The 5-year OS rate is a percentage, representing the fraction of randomized patients who, after 5 years, are still alive.|5 Years|||||||
1295151|NCT00085631|Primary|Five-Year Local Recurrence-Free Survival|Five-year local recurrence-free survival (LRFS) time was defined as the time from randomization until local progressive disease or death from any cause. Local recurrence was defined as evidence of disease progression on physical exam or radiologic study, confirmed histologically by tissue biopsy. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year LRFS rate is a percentage representing the fraction of randomized patients who, after 5 years, do not have local progression or are alive.|5 years|||||||
1295152|NCT00085631|Primary|Five-year Failure-free Survival|Five-year failure free survival (FFS) time was defined as the time from randomization until relapse/disease progression (local and/or distant) or death from any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year FFS rate is a percentage representing the fraction of randomized patients who, after 5 years, are disease free or alive.|5 Years|||||||
1295153|NCT00085631|Primary|Primary Tumor Response Rate at 4-6 Weeks Post Treatment|Primary tumor response rate is the proportion of subjects achieving a best response of complete (CR) or partial (PR) responses, according to the RECIST criteria for change in sum of longest diameters.|3 months from start of therapy|||||||
1295154|NCT00085566|Primary|Overall Objective Response|Response will be evaluated in this study using the new international criteria Response Evaluation Criteria in Solid Tumors (RECIST)|2 years||||participants|||Number
1295155|NCT00085540|Secondary|Response Rate Associated With Depsipeptide Therapy (Phase II)|"RECIST Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.~Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition"|Up to 2 years|GBM patients - no responses|||participants|||Number
1295156|NCT00085540|Primary|6 Months Progression-free Survival (Phase II)|evaluated patients with glioblastoma (GBM (35 patients)|At 6 months|evaluation of patients with GBM histology|||percentage of participants|||Number
1295157|NCT00085540|Primary|Number of Participants With Dose-limiting Toxicities Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I)|"dose limiting toxicity defined as: ANC </=1000 or Platelets <100K; SGOT >/= 3X ULN and T. Bili >/= 1.5 ULN~grade 3 Nausea, vomiting, fatigue and asymptomatic hypocalcemia (treatment may continue after discuss with PI)"|First 4 weeks of treatment||||participants|||Number
1295158|NCT00085436|Secondary|Immunity as Measured by T-cell and Antibody Responses to the Tumor|All patients receiving at least one week of treatment and have at least two time points available for assessment of immune parameters will be include in the evaluation of immune status.|monthly for 5 months||||pg/mL (picogram/milliliter)||95% Confidence Interval|Number
1295159|NCT00085436|Primary|Clinical Response as Measured by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|monthly, then every 2-3 months|Clinical response as measured by RECIST monthly and then every 2-3 months|||percentage of participants|Clinical Response|95% Confidence Interval|Number
1295160|NCT00085423|Secondary|Time to Progression as Measured by RECIST|Clinical outcome used the National Cancer Institute’s Response Evaluation Criteria in Solid Tumors (RECIST)1.0.|From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months||||years||95% Confidence Interval|Mean
1295161|NCT00085423|Secondary|Number of Participants With Lymphocyte Recovery as Measured by Blood Count|Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame.|on days 1-15, weekly for 2 weeks, and then every 2-3 months|each patient's differential blood counts were used to determine the time of recovery to the lower limit of normal lymphocytes in the peripheral blood.|||participants|||Number
1295162|NCT00085423|Primary|Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST|Objective response as measured by radiological and physical examination using RECIST criteria.|Response at 12 weeks|Response was determined by physical examination and radiologic testing. Percent of the total number of patients treated was calculated.|||participants|||Number
1295163|NCT00085410|Post-Hoc|6-Month and 1-Year Survival: Patients Who Did Not Derive Clinical Benefit From Study Treatment|The time from initiation of therapy to 6 months beyond. Only patients who did not derive clinical benefit from study treatment (progressive disease or unconfirmed partial response was best response) were included.|Up to 1 year|Patients who did not derive clinical benefit from study treatment (progressive disease was best response) only.|||percentage of patients|||Number
1295164|NCT00085410|Post-Hoc|6-Month and 1-Year Survival for Patients Who Derived Clinical Benefit From Study Treatment|The time from initiation of therapy to 6 months beyond. Only patients who derived benefit from study treatment (stable disease, partial response, or complete response was best response) were included.|Up to 1 year|Patients who derived benefit from study treatment (stable disease, partial response, or complete response was best response)|||percentage of patients|||Number
1295165|NCT00085410|Post-Hoc|1-year Survival|The time from initiation of initiation of therapy to 1 year beyond.|1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||percentage of patients|||Number
1295166|NCT00085410|Post-Hoc|6-Month Survival|The time from initiation of therapy to 6 months beyond.|6 months|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||percentage of patients|||Number
1295167|NCT00085410|Post-Hoc|Clinical Benefit Rate|Best response to study treatment was confirmed complete response, partial response, or stable disease. Unconfirmed partial response was not included. The outcome measure data table is stratified into patients who a) received prior therapy b) did not receive prior therapy.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||percentage of patients|||Number
1295168|NCT00085410|Secondary|Correlation of Treatment With Changes in Phenotypic Expression of Molecular Markers|Phenotypic expression of molecular markers before and after study treatment|Duration of study treatment|Insufficient amount of patient samples collected for analysis||||||
1295169|NCT00085410|Secondary|Correlation of Phenotypic Expression of NF-kB, p53, and Other Molecular Markers in Biliary Washings and Tumor Biopsies With Clinical Outcomes|Evaluation of clinical outcomes with expression of molecular markers specified and others. Sufficient amount of biliary washings and tumor biopsies needed for analysis.|Once in the screening period (within 14 days of starting treatment)|Insufficient amount of patient samples collected for analysis||||||
1295170|NCT00085410|Secondary|Correlation of the Degree of Proteasome Inhibition in Peripheral Blood With the Degree of Proteasome Inhibition in Tumor Specimens|Proteasome inhibition compared between tumor specimens and peripheral blood. Sufficient tissue samples are required for this analysis.|Once in the screening period (within 14 days of starting treatment)|Insufficient amount of patient samples collected for analysis||||||
1295171|NCT00085410|Secondary|Overall Survival|The time from initiation of therapy to death or last follow-up.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||months||95% Confidence Interval|Median
1295172|NCT00085410|Secondary|Time to Disease Progression|Time from initiation of therapy to first progressive disease.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||months||95% Confidence Interval|Median
1295176|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease|Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|3 months|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
1295177|NCT00085293|Secondary|Change in Fludeoxyglucose (FDG) Uptake Measured by Positron Emission Tomography in Metastatic Tumor Sites Before and After DNA-methyltransferase Inhibitor Therapy (Optional). No Secondary Endpoints Were Measured as no Patient Met the Primary Endpoint.||Baseline to 3 weeks|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
1295178|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease.|Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|6 months|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
1295179|NCT00085293|Secondary|Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Summary of Adverse Events (AEs) by Maximum Grade where Grade 1 AEs >20%, Grade 2 AEs >10%, all Grade 3, Grade 4 and Grade 5 reported.|Up to 6 months||||percentage of participants|||Number
1295180|NCT00085293|Primary|Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration|"Number of participants with restoration of radioiodine responsiveness as determined by visible uptake on radioiodine scan in radiographically detectable metastatic foci of papillary or follicular thyroid carcinoma. Response to Decitabine defined as demonstration of radioiodine uptake determined by centralized blinded review of diagnostic scan. All who demonstrated radioiodine uptake in metastatic foci following decitabine therapy would then undergo thyroid hormone withdrawal and a second course of decitabine in preparation for therapeutic administration of radioiodine.~Diagnostic radioiodine scans following decitabine therapy (week 3) with a radioiodine scan following thyrotropin alfa stimulation, 0.9 mg intramuscular (IM) injection 24 and 48 hours before administration of the 131I for imaging. Whole body scans (WBS) performed using a gamma camera."|Week 3 following 2 weeks of Decitabine therapy|Per protocol, 1 participant interpreted by local treating investigator as responsive (increased radioiodine uptake on diagnostic scan after therapy), entered second decitabine treatment receiving radioiodine therapeutic dose. Subsequent central review of both scans for formal protocol response interpreted scans as negative for radioiodine uptake.|||participants|||Number
1295181|NCT00085254|Primary|Overall Survival (Phase II)|The overall survival is calculated from time of histological diagnosis to death occurance - median based on all 112 patients, all dose levels|up to 36 months||||months||95% Confidence Interval|Median
1295182|NCT00085254|Secondary|Frequency of Hematologic and Nonhematologic Adverse Events|The proportion of patients with grade 3 and grade 4 hematologic and non hematologic adverse events per CTCAE 4.0|Up to 1 year||||Number of grade 3 or 4 events|||Number
1295183|NCT00085254|Secondary|Overall Survival Based on Dose Level - Phase 2|survival calculated from date of initial histologic diagnosis and occurence of death. Pts at 500mg dose compared against Pts treated at 2000mg dose. Calculated using median|Up to 3 years|Phase 2 subjects only - does not include the 18 subjects from the safety run-in portion of study|||months||95% Confidence Interval|Median
1295184|NCT00085254|Primary|Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses|"pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review any dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (safety run-in)~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~cohorts at these 3 defined doses: 500mg, 1000mg and 2000mg MTD defined as: dose producing DLT in 2 out of 6 patients or dose level below the dose which produced DLT in >/= 2 out of 3 patients, or in >/= 3 out of 6 patients If no MTD (maximum tolerable dose) was defined through 3 steps of dose escalation, phase 2 will proceed with a randomized treatment allocation of the two pre-specified dosage arms: low dose; 500mg and high dose; 2000mg"|10 weeks|at least 3 pts per cohort will be used to review MTD rate for dose escalation in stepwise fashion of 3 defined doses: 500, 1000 and 2000mg. We will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.|||mg|||Number
1295185|NCT00085254|Primary|Dose Limiting Toxicities of EMD + RT and TMZ|"pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"|10 weeks|at least 3 pts per cohort will be used to review DLT rate for dose escalation in stepwise fashion. we will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.|||participants|||Number
1295186|NCT00085202|Secondary|Mean RT Dose to Specified Target Tissue Volume by Rate and Pattern of Failure, e.g. Local Failure, Distant Failure, Etc.|To correlate radiation dosimetry of target and normal tissues with rate and patterns of failure and longitudinal measures of audiometric, endocrine and cognitive effects.|Once all patients have been followed for 2 years|||||||
1295189|NCT00085202|Primary|Frequency of Mutations Associated With SHH and WNT Tumors|The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.|within 3.5 years following completion of accrual|Only patients with WNT and SHH tumors with available tissue for targeted sequencing were analyzed for frequency of mutation. WNT and SHH subgroups were identified by methylation profiling.|||Participants|||Count of Participants
1295190|NCT00085202|Primary|Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.|122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.|2 years after tumor cell analysis in 122 participants|Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.|||percentage of participants||Standard Error|Mean
1295191|NCT00085202|Primary|Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors|The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.|2 years after tumor cell analysis in 122 participants|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.|||probability of PFS at 2 years||Standard Error|Mean
1295192|NCT00085098|Secondary|Quality of Life (QOL) and Neurocognitive Assessment (NP)|The primary endpoints for QOL and NP assessments will be the global scale value from each of these instruments at the two-year time point. Analyses of subscales (if they exist) and of assessments at other times will be of secondary interest. It is assumed that scale values are standardized to a reference normal population. The scores range from 0 to 100 with higher score reflecting better QoL or neurocognitive assessment.|2 years from beginning of treatment|All eligible patients who also successfully completed therapy and were assessed for quality of life and neurocognitive outcome.|||Scores on a scale||Standard Deviation|Mean
1295193|NCT00085098|Secondary|Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|The analysis of toxicity will focus on estimating the rates of key acute and subacute toxicity occurring during the first induction chemotherapy. The list of toxicities of interest include Anemia or Febrile Neutropenia; Nausea or Vomiting; Infections and Infestations; Neutrophil or White blood count decrease; and Hypokalemia or Hyponatremia|From the beginning of treatment, assessed up to 5 years|Patients who received any pre-radiotherapy chemotherapy in Regimen B|||Participants|||Count of Participants
1295194|NCT00085098|Secondary|Number of Participants With a Response to Regimen B|To assess the complete response rate to pre-radiotherapy chemotherapy (Reg B only). Response was determined after completing 2-4 cycles of chemotherapy on Reg B. Complete Response (CR) is defined as disappearance of all target lesions.|5 years from beginning of treatment|Patients who were treated in Regimen B and had at least one response assessment are included in this analysis. One patient in Regimen B withdrew from the pre-Radiotherapy chemotherapy and did not have any response assessment were not included for the response analysis.|||Participants|||Count of Participants
1295195|NCT00085098|Primary|Event-free Survival|"Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up.~QEs: 1)disease progression, defined as increase >= 40% in tumor volume or >= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause.~Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol’s primary objective.~NOTE: Reported data are through May 2009 (see Caveats section)."|Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years|By protocol design, all eligible patients were considered in the evaluation of primary study aim. Two (2) patients were considered ineligible. All other patients (10 enrolled to regimen A and 12 enrolled to regimen B) are included in the evaluation for the primary outcome measure.|||participants|||Number
1295196|NCT00084864|Secondary|Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0|Number of Participants with Adverse Events, Graded According to NCI CTCAE v2.0|Up to 30 days of the last administration of study procedure|All treated and eligible patients|||Participants|||Count of Participants
1295197|NCT00084864|Secondary|Determine the Acute Effects of This Regimen on Serum PSA in These Patients.||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.||||||
1295198|NCT00084864|Secondary|Determine the Effect of This Regimen on the Expression of Apoptosis Markers|Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.|Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.||||||
1295199|NCT00084864|Secondary|Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.||||||
1295200|NCT00084864|Primary|Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.||||||
1295201|NCT00084838|Other Pre-specified|Grade 3-4 Allergy/Immunology|All Grade 3-4 Allergy/Immunology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295202|NCT00084838|Other Pre-specified|Grade 3-4 Hemorrhage Events|All Grade 3-4 Hemorrhage events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295203|NCT00084838|Other Pre-specified|Grade 3-4 Dermatology Events|All Grade 3-4 Dermatology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295204|NCT00084838|Other Pre-specified|Grade 3-4 Renal/Genitourinary Events|All Grade 3-4 Renal/Genitourinary events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295205|NCT00084838|Other Pre-specified|Grade 3-4 Pulmonary Events|All Grade 3-4 Pulmonary events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295206|NCT00084838|Other Pre-specified|Grade 3-4 Cardiovascular Events|All Grade 3-4 Cardiovascular events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295207|NCT00084838|Other Pre-specified|Grade 3-4 Hepatic Events|All Grade 3-4 Hepatic events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295208|NCT00084838|Other Pre-specified|Grade 3-4 Muscloskeletal Events|All Grade 3-4 Muscloskeletal events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295209|NCT00084838|Other Pre-specified|Grade 3-4 Constitutional Events|All Grade 3-4 Constitutional events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295210|NCT00084838|Other Pre-specified|Grade 3-4 Pain Events|All Grade 3-4 Pain events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295211|NCT00084838|Other Pre-specified|Grade 3-4 Neurology Events|All Grade 3-4 Neurology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295212|NCT00084838|Other Pre-specified|Grade 3-4 Infection/Febrile Neutropenia Events|All Grade 3-4 Infection/Febrile Neutropenia events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295213|NCT00084838|Other Pre-specified|Grade 3-4 Metabolic/Laboratory Events|All Grade 3-4 Metabolic/Laboratory events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295214|NCT00084838|Other Pre-specified|Grade 3-4 Gastrointestinal Events|All Grade 3-4 Gastrointestinal events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295215|NCT00084838|Other Pre-specified|Grade 3-4 Blood/Bone Marrow Events|"All Grade 3-4 Blood/Bone Marrow events based on CTCAEv2 as reported on case report forms.~Arm Name"|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295216|NCT00084838|Other Pre-specified|Grade 3-4 Auditory/Hearing Events|All Grade 3-4 Auditory/Hearing events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
1295218|NCT00084838|Secondary|Pre-Radiation Therapy Chemotherapeutic Response|"Response pre-RT/post-CT was defined as follows with overall response defined as achieving PR or CR.~Complete Response (CR): Complete resolution of all initially demonstrable tumor on MRI or CT evaluation w/o appearance of any new areas of disease; negative CSF cytology. Partial Response (PR): >/= 50% decrease in the sum of the products of the maximum perpendicular diameters of the tumor (sum LD) relative to baseline w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Stable Disease (SD): <50% decrease in the sum LD w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Progressive Disease (PD): >/= 25% increase in the sum LD relative to baseline, or the appearance of any new areas of disease or appearance of positive cytology after two consecutive negative samples."|Assessed at study entry and pre-RT/post-CT at week 7.|The pre-RT CT response evaluable population is defined as patients who completed chemotherapy per protocol.|||proportion of evaluable patients||90% Confidence Interval|Number
1295219|NCT00084838|Primary|2-yr Overall Survival|Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient follow-up.|Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.|The analysis dataset is comprised of all eligible and treated patients.|||probability|||Number
1295220|NCT00084747|Secondary|Overall Survival||up to 5 years from time of consent||||months||Full Range|Median
1295221|NCT00084747|Primary|Progression-free Survival|Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.|signed consent to progression or end of trial. Up to 5 years.||||months||Full Range|Median
1295222|NCT00084682|Secondary|Overall Survival|All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.|Up to 2 years|||||||
1295223|NCT00084682|Secondary|Time to Progression|All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates.|Up to 2 years|||||||
1295224|NCT00084682|Secondary|Duration of Response||Up to 2 years|||||||
1295225|NCT00084682|Primary|Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)|Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria|Up to 2 years||||participation||95% Confidence Interval|Number
1295226|NCT00084617|Secondary|Overall Survival|Length of time patients survived after treatment|at 40 months from study activation|All patients enrolled in study|||months||95% Confidence Interval|Median
1295227|NCT00084617|Secondary|Complete Response (CR) and Partial Response (PR) Duration|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|at 40 months from study activation|Patients that achieved either a CR or PR.|||months||95% Confidence Interval|Median
1295228|NCT00084617|Primary|Response Rates (RR) in Metastatic Gastric/GE Junction Tumors|Response is defined as the number of patients with a CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of the target lesions or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage or increase of target lesions.|at 12 weeks (after 2 cycles of treatment)|Patients that completed at least 2 cycles of treatment|||participants|||Number
1295229|NCT00084487|Secondary|Overall Survival|Percentage of patients alive at 1 year|1 year|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1295230|NCT00084487|Secondary|Progression Free Survival|Percentage of patients that are progression free at 6 months.|6 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1295231|NCT00084487|Primary|Overall Survival|Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.|Up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
1295232|NCT00084487|Primary|Progression Free Survival|Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves.|Up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
1295233|NCT00084487|Primary|Objective Response Rate Estimated as the Proportion of Responders|"Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.~An exact binomial 95% confidence interval will be calculated for this proportion."|Up to 4 years|Intent to treat|||participants|||Number
1295234|NCT00084409|Other Pre-specified|To Determine Whether Iloprost Can Modulate a Panel of Biomarkes.|To determine if Iloprost can modulate a panel of biomarkers including MCM-2, EGFR, Her-2/neu, RARβ, p53, FHIT, apoptotic index, and microvessel density.|9 years|||||||
1295237|NCT00084409|Other Pre-specified|To Determine Whether Iloprost Affects Prostaglandin Metabolism by Examining 4 Markers, PGIS, COX-2, PPAR and PPAR.|PGIS (Prostacyclin synthase: an enzyme in the eicosanoid pathway that catalyzes the conversion of prostaglandin H2 to prostaglandin I2 (prostacyclin). PPAR (Peroxisome proliferator-activated receptor: a group of nuclear receptor proteins that act as transcription factors regulating gene expression),|Nine years|||||||
1295238|NCT00084409|Other Pre-specified|To Determine if Iloprost Can Modulate K-67 Proliferation Index in Patients at High Risk to Develop Lung Cancer||nine years|||||||
1295239|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.|||Percentage points||Standard Deviation|Mean
1295240|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.|||WHO Units||Standard Deviation|Mean
1295241|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.|||WHO Units||Standard Deviation|Mean
1295242|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years||||Percentage points||Standard Deviation|Mean
1295243|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years||||WHO Units||Standard Deviation|Mean
1295244|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies.~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years||||WHO Units||Standard Deviation|Mean
1295245|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years||||Percentage points||Standard Deviation|Mean
1295246|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years||||WHO Units||Standard Deviation|Mean
1295247|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL (Right upper lobe: the superior region of the right lung), RML (Right middle lobe: an anatomic portion of the right lung), RB6 (The carina in the right lower lobe at the entrance to the superior segment), LUL (Left upper lobe: the superior portion of the lung), LUDB (Left upper division bronchus: the carina between the lingular orifice and the left upper lobe), and LB6 (The carina in the left lower lobe at the entrance to the superior segment).~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years||||WHO Units||Standard Deviation|Mean
1295248|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies|"This outcome measure is created for each subject as follows:~From all biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From all biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years||||Percentage points||Standard Deviation|Mean
1295249|NCT00084409|Primary|Change in Average (Follow-up - Baseline) From All Biopsies|"This outcome measure is created for each subject as follows:~From all biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From all biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.Histology on bronchial biopsies pre-treatment and post-treatment will be compared. All biopsies will be graded according to the WHO classification for bronchial epithelium for this outcome, and all the following outcomes.~WHO Classification Grade Normal 1.0 Reserve Cell Hyperplasia 2.0 Metaplasia 3.0 Mild Dysplasia 4.0 Moderate Dysplasia 5.0 Severe Dysplasia 6.0 Carcinoma in Situ 7.0 Carcinoma 8.0~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|Nine years||||WHO Units||Standard Deviation|Mean
1295250|NCT00084383|Primary|Disease-free Survival|Disease-free Survival in Patients Treated With Adjuvant Chemoradiotherapy in Sequence With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. DFS is defined as time from surgery until clinical evidence of disease (eg, CT scan) or death due to any cause.|Participants were followed for the duration of the study, an average of 2 years||||Months||95% Confidence Interval|Median
1295251|NCT00084383|Secondary|Estimate the Association of Specific in Vivo Parameters of Immune Response With Clinical Responses in Patients Treated With Combination Chemoradiotherapy Together With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines.|The specific immune parameters include: post-vaccination delayed type hypersensitivity reactions to autologous tumor and the degree of local eosinophil, macrophage, and T cell infiltration at the vaccine site, and mesothelin-specific T cell responses.|Continuous|||||||
1295252|NCT00084383|Secondary|To Further Identify and Characterize Toxicities Associated With Intradermal Injections of the Vaccine That Were Initially Reported in the Phase 1 Trial.||4 years|||||||
1295253|NCT00084383|Primary|Overall Survival|Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.|Participants were followed for the duration of the study, an average of 2 years||||Months||95% Confidence Interval|Median
1295254|NCT00084318|Secondary|Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival||From randomization to two years|Effective and reliable assessment of nuclear expression of these receptors was not achieved and therefore no data was available for analysis.||||||
1295255|NCT00084318|Secondary|Local-regional Control|Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1295256|NCT00084318|Secondary|Frequency of Other Acute and Late Toxicity|Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.|From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants|||Number
1295257|NCT00084318|Secondary|Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)|Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was >30%. [RTOG = Radiation Therapy Oncology Group]|From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
1295258|NCT00084318|Secondary|Treatment Tolerance|Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.|From start of treatment to end of treatment (protocol treatment lasts seven weeks).|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
1295259|NCT00084318|Secondary|Overall Survival|Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
1295302|NCT00084084|Other Pre-specified|Heart Rate Variability - Change From Baseline at Week 185 in SDNN|Heart rate variability was assessed by 2-hour Holter monitoring. Standard deviation of all filtered RR intervals over the length of the analysis (SDNN) was measured.|Week 185|Number of participants present at Visit Week 185 included for analysis.|||msec||Standard Deviation|Mean
1295260|NCT00084318|Primary|Disease-free Survival|Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1295261|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for ITT Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|ITT population included all participants who received at least one dose of study medication.|||Days||Standard Error|Mean
1295262|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for mITT Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA.|||Days||Standard Error|Median
1295263|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for PP Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Days||Standard Error|Mean
1295264|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOT (within 72 hours of last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
1295265|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
1295266|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOS (7-30 days after last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
1295267|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOS for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
1295268|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOT (within 72 hours of last dose)|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
1295269|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
1295270|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOS (7-30 days after last dose)|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
1295271|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
1295272|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population|Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.|EOT (within 72 hours of last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
1295273|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population|Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
1295274|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population|Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.|EOS (7-30 days after last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
1295303|NCT00084084|Secondary|Pharmacokinetics - Area Under the Serum Concentration-Time Curve (AUC0-∞)|AUC0-∞ is a measure of the total exposure to a drug.|341 weeks|PK Population: All patients who received at least 1 dose of Replagal (RB or AF) and had at least 1 PK sample drawn.|||min·U/mL||Standard Deviation|Mean
1295275|NCT00084266|Primary|Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population|Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
1295276|NCT00084149|Secondary|CD4 T Cell Levels||At Week 48||||cells/mm^3||Inter-Quartile Range|Median
1295277|NCT00084149|Secondary|Number of Patients With Viral Load Less Than 50 Copies/ml||Week 48||||Participants|||Count of Participants
1295278|NCT00084149|Secondary|HIV-1 Viral Load Levels||At Week 48||||log10(copies/mL)||95% Confidence Interval|Mean
1295279|NCT00084149|Secondary|Proviral DNA (log10)||At Week 12||||log10(copies/mL)||Inter-Quartile Range|Median
1295280|NCT00084149|Secondary|Proviral DNA Levels (log10)||At Week 24||||log10(copies/mL)||Inter-Quartile Range|Median
1295281|NCT00084149|Secondary|Adverse Events Related to Study Medication|Grade 1-4 adverse events related to study medication|Up to 48 weeks||||participants|||Number
1295282|NCT00084149|Primary|Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)||At 48 weeks after the start of treatment|All participants completing week 48 visit.|||log10(copies/mL)||Inter-Quartile Range|Median
1295283|NCT00084136|Secondary|Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)|Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study follow-up until study closure (May 31, 2010)|Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.|||weeks||95% Confidence Interval|Number
1295284|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)|Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 96 using follow-up through study closure on May 31,2010||||weeks||95% Confidence Interval|Number
1295285|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 using follow-up through study closure on May 31,2010||||weeks||95% Confidence Interval|Number
1295286|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 96 (using follow-up through to study closure on May 31,2010)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.|||weeks||95% Confidence Interval|Number
1295287|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up through study closure on May 31,2010)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.|||weeks||95% Confidence Interval|Number
1295288|NCT00084136|Secondary|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)|Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.|At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)|ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.|||participants|||Number
1295289|NCT00084136|Secondary|Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)|Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).|weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)|ITT - ignoring both current treatment status and treatment history.|||cells/mm^3||Inter-Quartile Range|Median
1295290|NCT00084136|Secondary|Time to Immunologic Failure (NRTI Comparison)|Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.|At or after Week 48 (including all follow-up through study closure - May 31,2010)||||weeks||95% Confidence Interval|Number
1295291|NCT00084136|Secondary|Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)|Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).|Throughout follow-up until study closed (May 31,2010)|Participants not starting study treatment excluded.|||weeks||95% Confidence Interval|Number
1295292|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)|Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)||||weeks||95% Confidence Interval|Number
1295293|NCT00084136|Secondary|Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)|Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.|||weeks||95% Confidence Interval|Number
1295294|NCT00084136|Secondary|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)|Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.|At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)|ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.|||participants|||Number
1295295|NCT00084136|Secondary|Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)|Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)|Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.|||weeks||95% Confidence Interval|Number
1295296|NCT00084136|Secondary|Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)|Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).|weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)|ITT - ignoring both current treatment status and treatment history.|||cells/mm^3||Inter-Quartile Range|Median
1295297|NCT00084136|Secondary|Time to Immunologic Failure (PI Comparison)|Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.|At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)|ITT (ignoring current study treatment status or history)|||weeks||95% Confidence Interval|Number
1295298|NCT00084136|Secondary|Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)|Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).|Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)|Participants not starting study treatment excluded.|||weeks||95% Confidence Interval|Number
1295299|NCT00084136|Primary|Time to Treatment Failure (NRTI Comparison)|Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).|Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).|ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.|||weeks||95% Confidence Interval|Number
1295300|NCT00084136|Primary|Time to Treatment Failure (PI Comparison)|Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).|Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).|ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.|||weeks||95% Confidence Interval|Number
1295301|NCT00084084|Secondary|Pharmacokinetics - Maximum Observed Serum Concentration (Cmax)|Cmax is the peak plasma concentration of a drug after administration.|341 weeks||||U/mL||Standard Deviation|Mean
1295305|NCT00083915|Primary|Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.|Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)|3 years depending on start date|only 2 participants in high dose (HD) melphalan group completed the study and only 8 from the Mel-DT Pace group completed the study. No analysis done.||||||
1295306|NCT00083889|Secondary|Ctrough Concentrations of SU011248 and Active Metabolite SU012662|Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples at observation.|||ng/mL||Standard Deviation|Mean
1295307|NCT00083889|Secondary|Ctrough Concentrations of Metabolite SU012662|Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples|||ng/mL||Standard Deviation|Mean
1295308|NCT00083889|Secondary|Ctrough Concentrations of SU011248|Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples.|||ng/mL||Standard Deviation|Mean
1295309|NCT00083889|Secondary|Incremental Cost Effectiveness Ratio (ICER)|Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting.|post study measurement||||ratio|||Number
1295310|NCT00083889|Secondary|Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis|Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Day 1 & Day 28, Cycle 1 to Cycle 4|Pharmacodynamic analyses performed at selected sites on AT population who had at least one PK (pharmacokinetic) sample; n = subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively. Abbreviations: C = Cycle, D = Day, bFGF: basic fibroblast growth factor.|||pg/ml and ratio to Baseline||Standard Deviation|Mean
1295311|NCT00083889|Secondary|Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis|Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Day 1 & Day 28, Cycle 1 to Cycle 4|Pharmacodynamic analyses performed at selected sites on AT population who had at least one pharmacokinetic sample; n= SU011248, INF-α; Abbreviations: C: Cycle, D: Day, VEGF: vascular endothelial growth factor, sVEGFR-3: soluble vascular endothelial growth factor Receptor-3, IL-8: interleukin-8, bFGF: basic fibroblast growth factor.|||pg/ml and ratio to Baseline||Standard Deviation|Mean
1295312|NCT00083889|Secondary|Euro-QoL Visual Analog Scale (EQ-VAS)|EQ-VAS: overall self-rating rating of the patient’s current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
1295313|NCT00083889|Secondary|EuroQoL Five Dimension (EQ-5D) Health State Index|EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: –0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
1295314|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale|Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT|||scores on scale||Standard Deviation|Mean
1295315|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale|Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
1295316|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale|Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
1295317|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale|Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
1295318|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G)|Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient’s physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
1295319|NCT00083889|Primary|Progression-Free Survival (PFS), Investigator's Assessment|Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.|Day 28 of each 6-week cycle: duration of treatment phase|ITT|||weeks||95% Confidence Interval|Median
1295320|NCT00083889|Secondary|FACT-Kidney Symptom Index (FKSI) Subscale|FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
1295321|NCT00083889|Secondary|FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale|FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; summary of FKSI-DRS questionnaire results by treatment; N=number of subjects with evaluable data; n = number of subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively.|||scores on scale||Standard Deviation|Mean
1295322|NCT00083889|Secondary|Duration of Response (DR), Investigator's Assessment|Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.|Day 28 of each cycle: duration of treatment phase|ITT|||weeks||95% Confidence Interval|Median
1295323|NCT00083889|Secondary|Duration of Response (DR), Core Radiology Assessement|Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.|Day 28 of each cycle: duraton of treatment phase|ITT|||weeks||95% Confidence Interval|Median
1295406|NCT00082407|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 52 (percentage = [number of subjects with HbA1c <=7% at week 52 divided by number of subjects with HbA1c >7% at baseline] * 100%).|52 weeks|Last Observation Carried Forward; Intent to Treat|||percentage of participants|||Number
1295324|NCT00083889|Secondary|Time to Tumor Progression (TTP), Investigator's Assessment|TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.|Randomization to first documentation of tumor progression: duration of treatment phase|ITT|||weeks||95% Confidence Interval|Median
1295325|NCT00083889|Secondary|Time to Tumor Progression (TTP), Core Radiology Assessment|TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.|Randomization to first documentation of tumor progression: duration of treatment phase|ITT|||weeks||95% Confidence Interval|Median
1295326|NCT00083889|Secondary|Overall Survival (OS)|Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day.|Clinic visit or telephone contact every 2 months until death|ITT|||weeks||95% Confidence Interval|Median
1295327|NCT00083889|Secondary|Objective Response, Investigator's Assessment|Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study >= 4 weeks after initial documentation of response.|Day 28 of each 6-week cycle: duration of treatment phase|ITT|||participants|||Number
1295328|NCT00083889|Secondary|Objective Response, Core Radiology Assessment|Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study >= 4 weeks after initial documentation of response.|Day 28 of each 6-week cycle: duration of treatment phase|ITT|||participants|||Number
1295329|NCT00083889|Primary|Progression-Free Survival (PFS), Core Radiology Assessment|Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.|Day 28 of each 6-week cycle: duration of treatment phase|Intent to treat (ITT) population: all patients who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||weeks||95% Confidence Interval|Median
1295330|NCT00004146|Primary|Correlation Between PK CAI and Toxicity in This pt Population|PK paramenters including steady state CAI concentrations with toxicity/or drug activity|during treatment|50 subjects had PK samples for analysis|||ug/ml||Standard Deviation|Mean
1295331|NCT00004146|Primary|Toxicity of CAI When Combined With RT|patients who experienced a grade 3 or higher event considered at least possibly related to CAI|pts were reviewed for toxicity while on treatement - median time of 2 months|pts were treated for a median time of 2 months (23 days to 46 months). patients who experienced a grade 3 or higher event considered at least possibly related to CAI|||participants|||Number
1295332|NCT00004146|Primary|Overall Survival Rate|estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death|approximately 30 months|intent to treat pt population. time from histological diagnosis to death.|||months||95% Confidence Interval|Median
1295333|NCT00083759|Secondary|American College of Rheumatology (ACR)70|≥70% reduction from baseline in painful/tender joint count and swollen joint count and ≥70% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6||||participants|||Number
1295334|NCT00083759|Secondary|American College of Rheumatology (ACR)50|≥50% reduction from baseline in painful/tender joint count and swollen joint count and ≥50% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6||||participants|||Number
1295335|NCT00083759|Primary|American College of Rheumatology (ACR)20.|≥20% reduction from baseline in painful/tender joint count and swollen joint count and ≥20% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6||||participants|||Number
1295336|NCT00083720|Primary|Number of Participants With Serious Adverse Events|Reported SAEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities. The NCI-CTCAE Version 3.0 was used to grade all SAEs. An SAE was any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, was life threatening, required inpatient hospitalization or caused prolongation of existing hospitalization,congenital anomaly/birth defect, or any important medical event.|A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.|||Participants|||Number
1295337|NCT00083720|Primary|Number of Participants With Adverse Events|Reported adverse events (AEs) per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities dictionary. The National Cancer Insititute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).|An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.|||Participants|||Number
1295338|NCT00083720|Secondary|Overall Survival|This measure is defined as the time from the first day of therapy to the date of death. Survival of living patients or those lost to follow-up were censored on the last date the patients were known to be alive.|Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 months.|Overall survival was calculated from the time of the first day of therapy to the date of death for the mITT population.|||Months||95% Confidence Interval|Median
1295339|NCT00083720|Secondary|Time to Progression|This measure was defined as the time from the first day of treatment until the date of PD. Deaths without objective progression were censored. Patients who did not progress were censored at their last day of tumor assessment.|Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months).|This measure was calculated for the mITT population.|||Months||95% Confidence Interval|Median
1295340|NCT00083720|Secondary|Duration of Response|In patients with a best overall response of CR or PR, the duration of response is measured from the date criteria are first met for CR or PR, until the first date that Progressive Disease (PD) is objectively documented or death occurs. Duration of response of living patients with no evidence of PD was censored on the date of their last tumor assessment.|The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months).|The duration of response was calculated for the subgroup of the mITT population who demonstrated a response.|||Months||95% Confidence Interval|Median
1295341|NCT00083720|Secondary|Percentage of Participants With Disease Control (CR, PR, or SD)|This is the total number of patients with a best overall response of CR, PR, and stable disease (SD) divided by the total number of patients treated.|Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.|Disease control rate was the total number of patients with best overall response of CR, PR and SD divided by the total number of patients treated.|||Percentage of participants||95% Confidence Interval|Mean
1295342|NCT00083720|Primary|Percentage of Participants With an Overall Resonse|Determine the response rate (complete response [CR] and partial response [PR]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the World Health Organization (WHO) criteria. The calculation was the total number of patients with CR or PR divided by the total number of patients treated.|Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.|The overall response rate was calculated for the modified Intent to Treat (mITT) population.|||percentage of participants||95% Confidence Interval|Mean
1295343|NCT00083616|Secondary|Overall Survival|Kaplan-Meier estimate of median time from enrollment to death from any cause. Deaths were recorded during treatment, safety follow-up and long term follow-up.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||months||95% Confidence Interval|Median
1295344|NCT00083616|Secondary|Duration of Stable Disease|Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease. Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), with a best outcome of stable disease|||Weeks||95% Confidence Interval|Median
1295345|NCT00083616|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment. Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Weeks||95% Confidence Interval|Median
1295346|NCT00083616|Secondary|Time to Disease Progression|Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first). Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Weeks||95% Confidence Interval|Median
1295347|NCT00083616|Secondary|Progression-free Survival Time|Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first). Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Weeks||95% Confidence Interval|Median
1295348|NCT00083616|Secondary|Time to Response|Median time from enrollment to objective tumor response for participants who responded.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response|||Weeks||Inter-Quartile Range|Median
1295349|NCT00083616|Secondary|Number of Participants With Objective Tumor Response Throughout Study|Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Participants|||Number
1295350|NCT00083616|Primary|Duration of Response|The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Subset of the Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed obective tumor response|||Weeks||95% Confidence Interval|Median
1295351|NCT00083616|Primary|Number of Participants With Objective Tumor Response Through Week 16|Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|16 weeks|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Participants|||Number
1295352|NCT00083551|Primary|Overall Survival|Overall Survival at six years after initiating protocol therapy|6 Years||||percentage of participants|||Number
1295353|NCT00083382|Primary|Best Response|"Best response to study treatment as defined by protocol-specific response criteria:~Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (>20%) with <1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by > 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to <5%; Decrease in Bence-Jones proteinuria by >90%; No new lytic bone lesions or soft tissue plasmacytoma.~Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease."|2 years||||participants|||Number
1295354|NCT00082888|Secondary|Toxicity|Number of patients that experienced a grade 3 or 4 toxicity (adverse events considered at least possibly related to Tipifarnib) as measured by NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) v3.0|3/26/2004 - 2/1/2011|||||||
1295355|NCT00082888|Secondary|Duration of Response|Duration of response is defined for all evaluable patients that have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.|up to 2 years|||||||
1295356|NCT00082888|Secondary|Time to Progression|Time to progression was defined as the number of months from registration to the date of disease progression with patients being progression-free being censored on the date of their last evaluation.|up to 2 years|||||||
1295357|NCT00082888|Secondary|Overall Survival|Overall survival time was defined as the time from registration to the date of death or last follow-up.|Up to 2 years|||||||
1295358|NCT00082888|Primary|Proportion of Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment|Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.|During the first 6 cycles of treatment||||Proportion of confirmed responses||95% Confidence Interval|Number
1295359|NCT00082810|Secondary|Median Overall Survival|The 95% confidence intervals will be used.|From randomization until death or censored at the date of last follow-up, assessed up to 4 years||||months||95% Confidence Interval|Median
1295360|NCT00082810|Secondary|Toxicity as Assessed by NCI CTCAE Version 3.0|Number of Participants with serious (grade 3) or life-threatening (grade 4) adverse events|Up to 4 years|All treated patients who received at least one dose of tipifarnib were included in the safety analysis. A total of 342 cycles of therapy were administered (median 7 cycles/patient range 1-36 cycles)|||Participants|||Count of Participants
1295363|NCT00082810|Primary|Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)|Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 24 weeks||||participants|||Number
1295364|NCT00082758|Primary|Number of Responders (Response Rate)|Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.|Up to 30 weeks|Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.|||participants|||Number
1295365|NCT00082641|Primary|Peak Immune Response as Measured by Number of Spots Per Cells|This outcome measure examined the importance of vaccine timing on antigen-specific relative to the primary cytotoxic therapy on the augmentation of antigen specific immune responses by measuring the duration of immune responses of participants|6 months after last immunization|Due to the low numbers of participants analyze in each arm, 7 participants analyze in the Early vaccine administration 4 participants analyzed in the late vaccine administration the subjects were analyzed together for this outcome.|||spots per 300,000 cells||Full Range|Median
1295366|NCT00082641|Primary|Percent of Patients With an Immune Response to p53-infected Autologous Dendritic Cells||Through study completion||||percentage of patients|||Number
1295367|NCT00082641|Primary|Number of Participants Who Experienced Toxicity to the Vaccine|This outcome measure looks at the safety of the vaccine by documenting the number of grade 2, 3, or toxicities experienced by participants related to the vaccine.|1 week after each vaccine dose.||||Participants|||Count of Participants
1295368|NCT00083226|Secondary|Progression Free Survival|Time from registration to disease progression or death, whichever occurred earlier. Patients alive and progression-free were censored at last follow up. 36 eligible and treated patients were included in the analysis. The other 2 eligible and treated patients had no disease status information.|assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year.|eligible and treated patients with progression status information|||months||95% Confidence Interval|Median
1295369|NCT00083226|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause. Patients alive were censored at follow up. Analysis was conducted in the 38 eligible and treated patients.|assessed every 3 months for 2 years and then every 6 months for 1 year|eligible and treated|||months||95% Confidence Interval|Median
1295370|NCT00083226|Primary|Objective Response Rate Measured by Response Evaluation Criteria In Solid Tumors (RECIST)|Tumor response was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Objective response rate included complete response (disappearance of all tumor lesions) and partial response (At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.).|assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year|eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1295371|NCT00083174|Secondary|Incidences of Other Malignancies|Other malignancies includes any other malignancy which is not in breast.|Over randomization period of study (median follow-up 35 months)|Women who have received treatment|||participants|||Number
1295372|NCT00083174|Secondary|Incidence of Clinically Relevant Cardiac Events|Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths|During protocol treatment in randomization period (up to 5 years)|Women who received treatment during randomization period|||participants|||Number
1295373|NCT00083174|Secondary|Incidence of All Clinical Fractures||During protocol treatment over randomization period of study (up to 5 years)|Women who have received treatment|||participants|||Number
1295374|NCT00083174|Secondary|Number of Clinical Breast Biopsies||Over randomization period of study (median follow-up 35 months)|Women who had at least one clinical breast biopsy|||number of clinical breast biopsies||Full Range|Median
1295375|NCT00083174|Secondary|Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events||Over randomization period of study (median follow-up 35 months)|Intent-to-treat (ITT)|||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
1295376|NCT00083174|Secondary|Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer|It was estimated from the Total Breast Cancer-Free Survival (TBCFS), which was calculated for women who developed invasive or non-invasive (DCIS) breast cancer as the time from the date of randomization to the earliest date of diagnosis for invasive or non-invasive (DCIS) breast cancer. Women who died from other causes were censored at the time of death. Women who had breast cancer before entry were censored at the time of randomization. If a woman did not develop an invasive or non-invasive (DCIS) breast cancer, or died, TBCFS will be censored on the date of last known alive.|Over randomization period of study (median follow-up 35 months)|Intent-to-treat (ITT)|||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
1295377|NCT00083174|Primary|Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)|Invasive breast cancer incidence was estimated from the breast cancer-free survival (BCFS) which was calculated for all women from the day of the randomization to the earliest date of diagnosis for invasive breast cancer. Women who died from other causes were censored at the time of death. If a woman did not develop an invasive breast cancer, or died, BCFS was censored on the date of the last day the woman was known alive (LKA), which was the latest of the date of assessment. Women who had breast cancer before study entry were also censored at the time of randomization.|Over randomization period of study (median follow-up 35 months)|intention to treat (ITT)|||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
1295378|NCT00083174|Primary|Percentage of Women With Serious Adverse Events|Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.|5 years open-label extension period|Postmenopausal women who were randomized to exemestane in original MAP.3 study and chose to continue to receive exemestane for up to 5 years and those randomized to placebo and decided to start 5 years of exemestane.|||percentage of women||95% Confidence Interval|Number
1295379|NCT00083122|Secondary|Time to Progression|Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Time from registration to the date of progression or last follow-up, assessed up to 3 years|All 40 participants from Group 1 were analyzed. However, due to slow accrual and early closure, Group 2 was not statistically analyzed for this endpoint.|||months||95% Confidence Interval|Median
1295380|NCT00083122|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier.|Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years|All 40 participants in Group 1 were analyzed for this primary endpoint. However, due to the low accrual and early group 2 closure, Group 2 was not statistically evaluated for this endpoint.|||months||95% Confidence Interval|Median
1295381|NCT00083122|Primary|Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)|"A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers.~A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.~A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart."|24 weeks|All 45 participants were analyzed.|||Percentage of Participants|||Number
1295382|NCT00082628|Secondary|Treatment Period II: Failure Rate at Week 36 Based on Visceral Adipose Tissue (VAT) For Subjects Who Received Serostim® 4 mg in Period I|Failure rate based on VAT was assessed by CT scan at L4-L5. The failure rate was defined as the percentage of subjects who regained >50% of their VAT lost in Treatment Period I. This outcome was to be assessed for subjects who received Serostim® 4 mg in Period I.|Week 36|"The modified ITT Population for treatment period II was defined as subjects who were re-randomized into Weeks 12 to 36 of the study and who had at least one post-Week 12 efficacy evaluation. Here Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome."|||percentage of subjects|||Number
1295383|NCT00082628|Secondary|Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12|Lipid profile data was analyzed for Non-HDL Cholesterol.|Baseline, Week 12|"The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome."|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1295384|NCT00082628|Secondary|Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12|Body image distress was assessed on a scale ranging from 0 to 100, where 0 = Extremely Upsetting and 100 = Extremely Encouraging.|Baseline, Week 12|The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I.|||units on a scale||Standard Deviation|Mean
1295385|NCT00082628|Secondary|Treatment Period I: Change From Baseline in Trunk Fat at Week 12|Changes in trunk fat was measured as changes in mass (kg) on Dual-Energy X-Ray Absorptiometry (DXA) Scan.|Baseline, Week 12|"The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome."|||Kilogram (Kg)||Standard Deviation|Mean
1295386|NCT00082628|Primary|Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12|Absolute area of VAT was measured by cross-sectional computed tomography (CT) scan at the level of the L4-5 inter-vertebral disk. CT scanning was to be used to assess the cross sectional area of abdominal fat and its distribution between the visceral and subcutaneous compartments, as measured at L4-L5.|Baseline, Week 12|"The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome."|||Square Centimeter (cm^2)||Standard Deviation|Mean
1295387|NCT00082433|Primary|Overall Survival (OS)|Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.|from date of randomization until death|Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8.|||months||95% Confidence Interval|Median
1295407|NCT00082407|Primary|Change in Glcosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post-baseline data.|||percentage||Standard Error|Least Squares Mean
1295408|NCT00082368|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|69 months||||participants|||Number
1295388|NCT00082433|Secondary|Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)|Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.|Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment|Analysis was conducted on all randomized participants on an intent to treat basis. (Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)|||units on a scale||95% Confidence Interval|Mean
1295389|NCT00082433|Secondary|Treatment-Related Safety Summary|Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTC) Version 3.0|safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.|All patients who received at least 1 dose of ixabepilone and/or capecitabine. Participants with baseline hepatic impairment (combination arm, n = 50; capecitabine arm, n = 37), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths observed in study CA163-046.|||Participants|||Number
1295390|NCT00082433|Secondary|Time to Response|"Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for partial or complete (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure)."|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)|||weeks||Full Range|Median
1295391|NCT00082433|Secondary|Duration of Response|"Measured from the time RECIST criteria (described in previous outcome measure) were first met for complete or partial response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method."|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)|||Months||95% Confidence Interval|Median
1295392|NCT00082433|Secondary|Response Rate (RR)|"RR=number of patients in that group whose best response is partial(30% decrease in the sum of the longest diameter of target lesions) or complete (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants"|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated participants with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline).|||percentage of participants||95% Confidence Interval|Mean
1295393|NCT00082433|Secondary|Progression-Free Survival (PFS)|PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|All randomized patients with measurable disease as stratified at the time of randomization; n=480 and n=480 for the 2 treatment groups, respectively. Analysis was conducted once 903 progressions or deaths were observed in 960 participants.|||months||95% Confidence Interval|Median
1295394|NCT00082381|Secondary|Change in Rate of Hypoglycemic Events|Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26|Baseline, week 26|Intent to Treat|||events per 30 days per patient||Standard Error|Least Squares Mean
1295395|NCT00082381|Secondary|Percentage of Patients With Hypoglycemic Events|Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study|26 weeks|Intent to Treat|||percentage of participants|||Number
1295396|NCT00082381|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat|||mmol/L||Standard Error|Least Squares Mean
1295397|NCT00082381|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat|||mmol/L||Standard Error|Least Squares Mean
1295398|NCT00082381|Secondary|Change in Body Weight|Change in body weight from baseline to week 26|Baseline, week 26|Intent to Treat|||kg||Standard Error|Least Squares Mean
1295399|NCT00082381|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 26 (percentage = [number of subjects with HbA1c <=7% at week 26 divided by number of subjects with HbA1c >7% at baseline] * 100%).|26 weeks|Last Observation Carried Forward; Intent to Treat|||percentage of participants|||Number
1295400|NCT00082381|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post baseline data|||percentage||Standard Error|Least Squares Mean
1295401|NCT00082407|Secondary|Change in Rate of Hypoglycemic Events|Change in rate of hypoglycemic events per 30 days per patient from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat|||events per 30 days per patient||Standard Error|Least Squares Mean
1295402|NCT00082407|Secondary|Percentage of Patients With Hypoglycemic Events|Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study divided by the total number of patients who particiapted in the 52 week Parent Study|52 weeks|Intent to Treat|||percentage of participants|||Number
1295409|NCT00082368|Primary|Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist.|Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.|3 days||||% change in Tc-94m Sestamibi SUVmax||Full Range|Mean
1295410|NCT00082355|Secondary|Number of Participants That Developed Hemorrhage|The outcome measures the number of participants who developed hemorrhage after receiving up to 4 days of Alteplase treatment for DVT.|5 days|The number of participants analyzed is an Intent-to-Treat (ITT) population. The accrual target was to analyze outcomes(immediate, at 6 weeks, and at 6months) after treatment of DVT with alteplase in 25 patients. 30 patients were treated but two participants did not complete the study for 6 week and 6 month outcome assessments.|||participants|||Number
1295411|NCT00082355|Primary|Number of Participants With Restored Venous Function|The outcome measures the ability of Alteplase to lyse acute and subacute deep venous thrombosis (DVT) of the lower extremities and/or pelvis and restore venous function, or blood flow, to these areas. Restored venous function is also known as patency. Patency is measured by venography and ultrasound exams.|6 months|The number of participants analyzed is an Intent-to-Treat (ITT) population. The initial goal was to be able to evaluate outcomes of treatment of DVT with alteplase over a 6 month period in 25 patients. 30 patients were treated but two participants did not complete the study before being assessed for this outcome measure.|||participants|||Number
1295412|NCT00082342|Secondary|Bradykinesia Measure Before and After Real and Sham tDCS.|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post, 1 month post, 3 months post tDCS||||seconds||Standard Deviation|Mean
1295413|NCT00082342|Secondary|UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham. Subjects were assessed on medication and off medication.|baseline, 1 day post, 1 month post, and 3 months post real and sham tDCS||||units on a scale||Standard Deviation|Mean
1295414|NCT00082342|Secondary|UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall clinical rating scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score was obtained from subject examination, subject interviews and questionnaires. The UPDRS encompasses measurement of mentation, behavior, mood, activities of daily living and motor skills. The total UPDRS scores ranges from 0 (not affected) to 176 (most severely affected). The UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham, while on medication and off medication.|baseline, 1 day post, 1 month post, 3 months post-tDCS||||units on a scale||Standard Deviation|Mean
1295415|NCT00082342|Primary|Gait Speed Before and After Real and Sham tDCS.|Gait speed was measured by the time it took the subject to walk 10m. Subjects were instructed to walk at a fast pace without taking the risk of falling, wearing the same shoes and using assistive devices consistently if needed. Gait speed was measured at baseline and post-tDCS.|baseline, 1 day post, 1 month post, 3 months post-tDCS|Intent to treat|||Seconds||Standard Deviation|Mean
1295416|NCT00082329|Secondary|To Examine 1) the Cellular Content and Other Immune Properties of Mobilized Cells; 2) Yields of Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis; and 3) Safety Profile of AMD3100.||Through day 7|||||||
1295417|NCT00082329|Primary|To Determine the Cytokine Polarization Status of Cluster of Differentiation 4 (CD4)+ T-cells Collected by Apheresis Following Combination of AMD3100 and G-CSF Compared to G-CSF Mobilization.|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization. The successful treatment responders will complete study treatment with cell mobilization and cell collection. Non-responders will have completed the study treatment and have cell mobilization without cell collection."|Day 1 (cells are counted 24 hours after AMD3100)||||participants|||Number
1295418|NCT00082173|Secondary|Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications|Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications|8 weeks|DAIDS Table of Adverse Events|||Participants|||Number
1295419|NCT00082173|Primary|Proportion of Patients With Sterile Sputum Cultures|Proportion of patients with sterile sputum cultures|8 weeks|Proportion of patients with sterile sputum cultures at week 8|||Participants|||Number
1295420|NCT00003726|Primary|Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer|Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.|18 months|No data were collected||||||
1295421|NCT00081939|Primary|Percentage of Participants With Progression-Free Survival (PFS) at 3 Years From Initiation of Study Treatment|In patients with no confirmed Partial Response, Near Complete Response, or Complete Response, progression was defined as a >25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.|3 years||||percentage of participants|||Number
1295422|NCT00082017|Other Pre-specified|Effect of UCN-01 on Anaplastic Lymphoma Kinase (ALK) Expression in ALCL|Gene expression patterns in participants ALK positive tumors will be assessed.|Day 3-5 after drug administration|This outcome measure was not done because data were insufficient to assess for possible effects of UCN-01 on ALK expression.||||||
1295423|NCT00082017|Other Pre-specified|Evaluation of Mature T-cell Lymphoma Cells by Complementary Double-Stranded Deoxyribonucleic Acid (cDNA) Microarray|Mature T-cells will be analyzed to identify gene expression changes that correlate with loss of a tumor suppressor gene in a human melanoma cell line.|Day 3-5 after drug administration|This outcome measure was not done because there were inadequate samples to evaluate mature T cell lymphoma malignant cells by cDNA microarray.||||||
1295424|NCT00082017|Other Pre-specified|Effect of UCN-01 on Soluble TAC Cluster of Differentiation 25 (CD25)|Soluble TAC (CD25) levels will be assessed in patients with anaplastic large cell lymphoma.|Day 3-5 after drug administration|This outcome measure was not done because data were insufficient to assess for possible effects on soluble TAC (CD25) levels.||||||
1295425|NCT00082017|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|76 months||||Participants|||Number
1295426|NCT00082017|Primary|Overall Survival (OS)|OS is defined as the date of on-study to the date of death from any cause or last follow up.|55 months||||months||95% Confidence Interval|Median
1295427|NCT00082017|Primary|Progression Free Survival (PFS)|PFS is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression is assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as a ≥50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for partial response's or non-responders or appearance of any new lesion during or at the end of therapy.|3.6 months||||months||95% Confidence Interval|Median
1295428|NCT00082017|Primary|Clinical Response Rate|Clinical Response Rate is the percentage of participants with a response assessed by the International Workshop to Standardize Response Criteria. Complete response (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (CRu) is per CR criteria except that if a residual node is >1.5cm, it must have regressed by >75%. Partial response (PR) is no increase in size of nodes, liver or spleen. Progressive disease (PD) is a greater than or equal to 50% increase from nadir. Details re: response criteria, see the protocol link module|74.5 months||||Percentage of participants|||Number
1295429|NCT00081861|Primary|Number of Participants With Response (Complete Response or Progressive Disease)|Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as “complete disappearance” of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.|After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),|Two participants received first treatment dose but were not eligible for response.|||Participants|||Number
1295430|NCT00081770|Secondary|Mean Change From Baseline in the Log Viral Load at Treatment Week 2|The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.|Assessed at Baseline and Treatment Week 2|ITT Population defined as subjects who received at least one dose of study medication|||Log10 IU/mL||Standard Deviation|Mean
1295431|NCT00081770|Secondary|Virologic Response Rate at Treatment Week 12|Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12|Assessed at Treatment Week 12|ITT Population defined as subjects who received at least one dose of study medication|||Percentage of participants|||Number
1295432|NCT00081770|Secondary|Mean Change From Baseline in the Log Viral Load at Treatment Week 4|The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.|Assessed at Baseline and Treatment Week 4|ITT Population defined as subjects who received at least one dose of study medication|||Log10 IU/mL||Standard Deviation|Mean
1295433|NCT00081770|Primary|Sustained Virologic Response (SVR) Rate|SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.|Assessed at the end of a 24-week post-treatment follow-up|Intent-to-Treat [ITT] Population defined as subjects who received at least one dose of study medication|||Percentage of participants|||Number
1295434|NCT00081731|Primary|Need for Renal Replacement Therapy||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
1295435|NCT00081731|Primary|30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
1295436|NCT00081731|Primary|Stroke||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
1295437|NCT00081731|Primary|Hospitalization for Congestive Heart Failure||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
1295438|NCT00081731|Primary|Myocardial Infarction||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
1295439|NCT00081731|Primary|Cardiovascular or Renal Death||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
1295440|NCT00081731|Primary|Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy|Only the first event per participant is included in the composite|Measured at every 3 months for the first year and annually thereafter||||participants|||Number
1295441|NCT00081653|Secondary|Relative Percent Change From Baseline of Trough Serum CTX|CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.|Baseline, 6,12, 24 and 36 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percent change||Standard Deviation|Mean
1295536|NCT00002540|Secondary|Deaths From All Causes|Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009.|All male participants were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1295442|NCT00081653|Primary|Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)|BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).|Baseline and Months 12, 24 and 36|ITT population: n = number of participants analyzed for the given parameter at the specified visit.|||percent change||Standard Deviation|Mean
1295443|NCT00081653|Primary|Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD|Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).|Baseline and Months 12, 24 and 36|ITT population; number (n) equals (=) number of participants analyzed at the specified visit.|||g/cm^2||Standard Deviation|Mean
1295444|NCT00081653|Secondary|Absolute Change From Baseline of Trough Serum CTX|CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.|Baseline, 6, 12, 24 and 36 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||ng/mL||Standard Deviation|Mean
1295445|NCT00081653|Secondary|Relative Percent Change From Baseline in Mean Total Hip BMD|BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).|Baseline, 12, 24 and 36 months|ITT Population; n = number of participants analyzed for the given parameter at the specified visit.|||percent change in BMD||Standard Deviation|Mean
1295446|NCT00081653|Secondary|Absolute Change From Baseline in Mean Total Hip BMD|BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).|Baseline and 12, 24 and 36 months|ITT Population; n = number of participants analyzed for the given parameter at the specified visit.|||g/cm^2||Standard Deviation|Mean
1295447|NCT00081497|Secondary|Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme and 6, 12, and 18 months|ITT population–62 patients had assessments at 6 months, 61 patients had assessments at 12 months, and 54 patients had assessments at 18 months in the open-label extension study.|||urine protein(mg/dL) / creatinine(mg/dL)||Standard Deviation|Mean
1295448|NCT00081497|Secondary|Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is ≤ 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL00800 for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL00800; assessment prior to first Fabrazyme infusion in AGAL02503 for placebo patients who did not transition to Fabrazyme in AGAL00800.|Pre-Fabrazyme and 6, 12, and 18 months|ITT population–64 patients had assessments at 6 and 18 months while 65 patients had assessments at 12 months in the open-label extension study.|||µg/mL||Standard Deviation|Mean
1295449|NCT00081497|Secondary|Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-00-800 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme, 6, 12, and 18 months|ITT population–67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.|||ml/min/1.73m^2||Standard Deviation|Mean
1295450|NCT00081497|Secondary|Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme, 6, 12, and 18 months|ITT population–67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.|||mg/dL||Standard Deviation|Mean
1295451|NCT00081497|Post-Hoc|Differences in Slopes of Estimated Glomerular Filtration Rate (eGFR) Comparing Randomized Placebo vs Fabrazyme Patients (Based on the Original Randomization in AGAL-008-00 (NCT00074984)) by Baseline eGFR Subgroups of >60 and ≤60 mL/Min/1.73 m^2.|Summary of differences in slopes of eGFR comparing randomized placebo vs Fabrazyme patients by baseline eGFR subgroups. Differences in slopes are the placebo slope minus the Fabrazyme slope. Therefore, a negative difference indicates a greater decline in the placebo patients relative to the Fabrazyme patients.|Throughout study; 18 months|ITT population. For subgroup Estimated Glomerular Filtration Rate (eGFR) >60, there were 9 placebo patients and 15 Fabrazyme patients. For subgroup eGFR ≤60, there were 19 placebo patients and 24 Fabrazyme patients. For randomized Fabrazyme patients, both the double-blind and open-label data was used.|||mL/min/1.73m^2/year||Standard Error|Least Squares Mean
1295452|NCT00081497|Primary|Difference in Inverse Serum Creatinine Within Patients' Slopes Between the Placebo AGAL-008-00 (NCT00074984) and Fabrazyme AGAL02503 (NCT00081497) Periods|The primary efficacy analysis was the summary of change in slope of inverse serum creatinine for Placebo/Fabrazyme patients in the Intent to Treat (ITT) Population. It compared the placebo period slope with the Fabrazyme period slope.|Placebo period AGAL-008-00 (up to 35 months) through Fabrazyme period AGAL02503 (18 months)|ITT Population - Analysis compares results during the placebo period with those during the Fabrazyme period and includes only the 28 patients who were randomized to placebo in the AGAL-008-00 (NCT00074984) study; as such no formal sample size calculations were performed.|||dL/mg/year||Standard Error|Least Squares Mean
1295453|NCT00081458|Secondary|Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24|An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.|6 months of treatment||||participants|||Number
1295454|NCT00081458|Primary|A Graded Response Score in Parenteral Nutrition (PN) Reduction|"The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24.~Zero (0 - lowest) assigned if <20% reduction at Wk20-24 and reduction at Wk16-20 of < 20%, 20-39%, or >=40%.~One (1) assigned if reduction of 20-39% at Wk20-24 but < 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND <20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20.~Three (3) assigned if reductions of 100% at Wk20-24 AND <20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND >=40% at Wk16-20.~Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND >=40% at Wk16-20."|6 months|Intent to Treat (ITT) analysis using a stepdown procedure that was stopped if the 0.10 mg/kg dose was not significantly better than placebo.|||participants|||Number
1295455|NCT00081328|Secondary|Comorbidity -- Triglycerides Dyslipidemia|A diagnosis was made by an out-of-range value >=150 mg/dL sustained over 6 months or on appropriate lipid lowering medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.|||participants|||Number
1295456|NCT00081328|Secondary|Comorbidity -- LDL Dyslipidemia|A diagnosis was made from out-of-range value >= 130 mg/dL sustained over 6 months or put on lipid lowering medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.|||participants|||Number
1295457|NCT00081328|Secondary|Comorbidity -- Hypertension|A diagnosis was made by an out-of-range value >=95th percentile or systolic >=130 or diastolic >=80 sustained over 6 months or on an anti-hypertensive medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.|||participants|||Number
1295458|NCT00081328|Secondary|Body Composition -- Fat Mass|Determined by DXA whole body scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.|24 months|Members of the cohort measured at 24 months who did not experience treatment failure.|||kg||Standard Deviation|Mean
1295459|NCT00081328|Secondary|Body Composition -- Bone Density|Measured by DXA, both whole body scan and AP-spine scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.|24 months|Members of the cohort measured at 24 months who did not experience treatment failure.|||g/cm squared||Standard Deviation|Mean
1295460|NCT00081328|Secondary|Body Composition -- Waist Circumference|Waist circumference (cm) measured at the iliac crest at its outermost point with the measuring tape placed around the participant in a horizontal plane parallel to the floor at the mark and the measurement teken at the end of normal expiration without the tape compressing the skin. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Members of cohort measured at 24 months who had not experience treatment failure.|||cm||Standard Deviation|Mean
1295461|NCT00081328|Secondary|Body Composition -- BMI|Body mass index (BMI) measured in kg per meters squared. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Cohort measured at 24 months and had not experienced treatment failure.|||kg per meters squared||Standard Deviation|Mean
1295462|NCT00081328|Secondary|Insulin Secretion|Insulinogenic index determined from OGTT as difference in insulin at 30 minutes minus 0 minutes divided by difference in glucose at 30 minutes minus 0 minutes. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Participants who were measured at 24 months and had not experience treatment failure.|||uU/mL divided by mg/dL||Inter-Quartile Range|Median
1295463|NCT00081328|Secondary|Safety|Number of serious adverse events reported during the trial. Participant could have multiple episodes reported.|Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.|Entire cohort.|||episodes of serious adverse event|||Number
1295464|NCT00081328|Secondary|Insulin Sensitivity|All participants were followed to 24 months. Insulin sensitivity is measured from OGTT as inverse of fasting insulin (mL/uU). The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Participants who were measured at 24 months and had not experienced treatment failure.|||mL/uU||Inter-Quartile Range|Median
1295465|NCT00081328|Primary|Treatment Failure (Loss of Glycemic Control)|Defined as A1c persistently >=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin)|Study duration - 2 years to 6.5 years of follow up from randomization|The entire cohort of 699 participants was included in the analysis.|||participants|||Number
1295466|NCT00081289|Secondary|Quality of Life as Assessed After Completion of Chemoradiotherapy and Adjuvant Chemotherapy and Then at 2 Years||From randomization to 3 timepoints: 1) completion of chemoradiation, 2) completion of post-operative chemotherapy (approximately 1 year), and 3) two years|||||||
1295467|NCT00081289|Secondary|Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens||End of study|||||||
1295468|NCT00081289|Secondary|Incidence of Hematologic and Non-hematologic Grade 3-4 Toxicity (Preoperatively, Postoperatively, and Overall)||Three time frames: start of treatment to surgery, surgery to end of follow-up, and combined.|||||||
1295469|NCT00081289|Secondary|Time to Treatment Failure and Patterns of Failure||From randomization to date of local failure, regional failure, distant failure, death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|||||||
1295866|NCT00075829|Secondary|Interval From First to Second Transplantation|Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients will receive a second transplant according to treatment assignments.|Year 1|Patients that completed second transplant|||days||Full Range|Median
1295470|NCT00081289|Primary|Pathologic Complete Response Rate|"A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study’s surgical oncology co-chair for the determination of pCR.~Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial."|After protocol surgery|For each arm the first 48 eligible enrolled after the protocol amendment.|||percentage of participants||95% Confidence Interval|Number
1295471|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Angiogenisis (VEGF)||Up to 18 weeks|||||||
1295472|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Apoptosis Index (TUNEL Assay)||Up to 18 weeks||2099-01-31|01/2099||||
1295473|NCT00081263|Other Pre-specified|The Number of Quadrants Involving CIN||Up to 18 weeks|||||||
1295474|NCT00081263|Other Pre-specified|Proportion of Patients Whose Eligibility Can be Successfully Determined Using the Web-based Review||Baseline|||||||
1295475|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Proliferation Index (Ki67).||Up to 18 weeks|||||||
1295476|NCT00081263|Other Pre-specified|To Determine the Feasibility of Digital Imaging Using Pathologist’s Diagnosis and Diagnostic Technique (Web-based or Standard Method).||Baseline|||||||
1295477|NCT00081263|Other Pre-specified|Levels of Serum VEGF||Up to 18 weeks|||||||
1295478|NCT00081263|Other Pre-specified|Levels of Serum bFGF||Up to 18 weeks|||||||
1295479|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment.||Up to 18 weeks|||||||
1295480|NCT00081263|Other Pre-specified|HPV Viral Load Before and After Treatment||Up to 18 weeks|||||||
1295481|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment||Up to 18 weeks|||||||
1295482|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in COX-2 in Tissue||Up to 18 weeks|||||||
1295483|NCT00081263|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients.|||participants|||Number
1295484|NCT00081263|Primary|Histologic Regression|Whether or not patients with CIN 2/3 or CIN 3 upon entry experience a complete remission (or partial regression to CIN 1) in the post-treatment excisional biopsy.|Post treatment evaluation was done 14 to 18 weeks after treatment randomization|Eligible, Treated, and Evaluable patients|||percentage of participants||90% Confidence Interval|Number
1295485|NCT00081159|Other Pre-specified|Overall Survival (OS)|Overall Survival defined as the length of time from the start of treatment till time that participants are still alive.|Up to 90 months|Intent to treat population analysis.|||Months||95% Confidence Interval|Median
1295486|NCT00081159|Secondary|Major Bone Scan Response|Bone scan performed at baseline and at Week 13 provided if baseline scan was positive for metastases. A major bone scan response was considered with a substantial resolution of participant bone metastases on the bone scans, i.e. complete resolution of the osseous metastases on the bone scan.|Week 13|Five participants in the non-Strontium arm were not evaluable for this outcome, four withdrew prior to treatment, and one had disease progression that precluded inclusion. Two participants in the Strontium arm were lost to follow up therefore excluded from analysis as well.|||participants|||Number
1295487|NCT00081159|Primary|Progression Free Survival (PFS)|Study’s primary endpoint of PFS duration/time to progression was defined as the time from the date of randomization to the date of first evidence of disease progression or patient death. Prostate-specific antigen (PSA) progression is usually the first evidence of progression. PSA progression is defined as a 25% increase over the baseline or the nadir provided that the increase is a minimum of 1 ng/ml.|Up to 90 months with evaulation in 4 week intervals for up to 6 months of treatment, then follow up until disease progression|Intent to treat population analysis.|||Months||95% Confidence Interval|Median
1295488|NCT00080938|Secondary|Overall Survival Time|Overall survival (months) was calculated from time of protocol entry to time of death from any cause. Patients alive at last follow-up were censored. The 21 eligible and treated patients were included in the analysis.|assessed every 3 months for 2 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1295489|NCT00080938|Secondary|Time to Non-CNS (Systemic) Progression|Time to non-CNS progression was calculated from time of protocol entry to time of first systemic progressive disease or death. Patients alive and non-CNS progression-free at last follow-up were censored. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter (per RECIST criteria). Development of new lesions in non-CNS sites also constituted non-CNS progression. The 21 eligible and treated patients were included in the analysis.|assessed every 3 months for 2 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1295490|NCT00080938|Secondary|1-year Neurologic (Central Nervous System, CNS) Progression Free Rate|1-year CNS progression free rate is the percentage of patients who had no CNS progression after being followed for 1 year . Progressive disease (CNS) was defined as a 25% or greater increase in the sum of the product(s) of the maximal cross-sections on MRI scan, reappearance of any lesion that has disappeared, development of any new lesion(s), stable disease with a deterioration of neurologic exam, or clear worsening of any evaluable disease.|assessed every 3 months for 2 years|Eligible, treated patients|||percentage of participants||95% Confidence Interval|Number
1295537|NCT00002540|Primary|Prostate Cancer Deaths|Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1295491|NCT00080938|Primary|Number of Patients With Intracranial Response|Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR|assessed every cycle while on treatment, then every 3 months for 2 years|Eligible and treated patients|||participants|||Number
1295492|NCT00080912|Primary|Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment|The primary endpoint of this study is Overall Response Rate (complete response and partial response) at two months after the first fraction of re-irradiation; patients with a third radiation treatment (the second re-irradiation) before month two will not have response attributed to the study treatment.|2 months|Intend to treat (ITT) population|||percentage of response||95% Confidence Interval|Number
1295493|NCT00080899|Secondary|Time to PSA Progression|Was summarized using the product-limit (Kaplan-Meier) method. In patients whose PSA levels initially decreased, PSA progression was defined as a 25% increase over the nadir (postenrollment PSA value up to that point), and an increase in the absolute value in the PSA value of 5 ng/mL, relative to the lowest postenrollment PSA value up to that point, including the baseline PSA level – and which was confirmed by second value 3-4 weeks later. A best response of PSA-PD was recorded for those patients who did not achieve a confirmed PSA-N or PSA-PR and who experienced PSA progression within 3 months of start of treatment.|From the start of treatment until the date of the first documentation of PSA progression, assessed up to 5 years||||months||95% Confidence Interval|Mean
1295494|NCT00080899|Primary|PSA Response|PSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.|Baseline to 5 years||||participants|||Number
1295495|NCT00080535|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.||||Participants|||Count of Participants
1295496|NCT00080535|Primary|Response Rate|Response is assessed by the International Workshop's Response Criteria (IWRC) for Non-Hodgkin's Lymphomas which favors the sum of the bidimensional products for tumor measurements. Complete response is no evidence of disease. Complete response unconfirmed (CRu) is a complete response in every category except CRu in lymph nodes. Partial response is a partial response in every measurable category with non-progressive disease elsewhere. Progressive disease is progressive disease in every category. Stable disease is neither partial response nor progressive disease. For additional details about the IWRC see the protocol link module.|Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.||||Participants|||Number
1295497|NCT00080483|Other Pre-specified|Increased Cortical Thickness and Cortical Density, as Determined by Peripheral Quantitative Computed Tomography of the Tibial Metaphysis||2 years|||||||
1295498|NCT00080483|Other Pre-specified|Improved Architectural Parameters of Trabecular Bone Reflecting Connectivity, as Determined by Magnetic Resonance Imaging||2 years|||||||
1295499|NCT00080483|Other Pre-specified|Increased Trabecular Thickness, as Determined by Magnetic Resonance of the Distal Tibia||2 years|||||||
1295500|NCT00080483|Primary|MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.|Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia|baseline, one year, two years|All subjects who had both baseline and one year evaluations|||unitless||Standard Error|Mean
1295501|NCT00002525|Secondary|5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B2 disease who had complete disease assessment data|||proportion of participants||95% Confidence Interval|Number
1295502|NCT00002525|Secondary|5-year Overall Survival Rate in Patients With Dukes' B2 Disease|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B2 disease|||proportion of participants||95% Confidence Interval|Number
1295503|NCT00002525|Secondary|5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B3 and C disease who had complete disease assessment data|||proportion of participants||95% Confidence Interval|Number
1295504|NCT00002525|Primary|5-year Overall Survival Rate in Patients With Dukes' B3/C Disease|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B3 and C disease|||proportion of participants||95% Confidence Interval|Number
1295505|NCT00080470|Primary|Freedom From Major Complications||5 years||||Number of Adverse Events|||Number
1295506|NCT00080470|Primary|Number of Leaks Per Day||12 months||||Number of Leaks Per Day||Standard Deviation|Mean
1295507|NCT00080301|Secondary|Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)|Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.|Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.|Analysis was conducted on all randomized participants on an intent to treat basis.(Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)|||units on a scale||95% Confidence Interval|Mean
1295508|NCT00080301|Secondary|Treatment-related Safety Summary|Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0|safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.|All treated participants; all participants who received at least 1 dose of study therapy.Participants with baseline hepatic impairment (combination arm, n = 29; capecitabine arm, n = 35), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths.|||Participants|||Number
1295509|NCT00080301|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.|from date of randomization until death|Overall survival was analyzed on all randomized patients on an intent to treat basis.|||Months||95% Confidence Interval|Median
1295510|NCT00080301|Secondary|Time to Response Per IRRC|Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|Results for time to response apply to only those subjects with a response (defined as complete or partial response)|||weeks||Full Range|Median
1295511|NCT00080301|Secondary|Duration of Response Per IRRC|"Computed for all patients with a best response of Partial or Complete per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death."|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|Results for duration of response apply to only those subjects with a response (defined as complete or partial response).|||months||95% Confidence Interval|Median
1295512|NCT00080301|Secondary|Overall Response Rate (ORR) Per IRRC|"Participants with best response of Complete or Partial according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions"|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|The analysis of ORR was conducted on all randomized patients on an intent to treat basis.|||percent||95% Confidence Interval|Mean
1295513|NCT00080301|Primary|Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)|PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn’t progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|PFS was analyzed on all randomized patients on an intention to treat basis.|||Months||95% Confidence Interval|Median
1295514|NCT00080288|Primary|Clinical Global Impression of Change (CGI-C)|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|up to 12 weeks|"Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug~Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy."|||Participants|||Number
1295515|NCT00080288|Primary|Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit).|up to 12 weeks|"Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug~Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy."|||Minutes||Standard Deviation|Mean
1295516|NCT00080223|Secondary|Overall Survival|Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment.|First dosing of study treatment until death (up to 604 weeks)|All treated participants|||weeks||95% Confidence Interval|Median
1295517|NCT00080223|Secondary|Resting Oxygen Saturation by Pulse Oximetry (SpO2)|SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air.|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.|||percentage of oxygen saturation||Standard Deviation|Mean
1295599|NCT00079183|Secondary|Secondary Malignancies|Proportion of participants who developed at least one secondary malignancy by 7 years|Up to 7 years||||Participants|||Count of Participants
1295600|NCT00079183|Secondary|Proportion With Infections Categorized by Organism||Approximately 7 years||||Participants|||Count of Participants
1295518|NCT00080223|Secondary|Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)|DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = [Hbg-corrected DLco value (in milliliters per minute per millimeter mercury [mL/min/mmHg])/predicted DLco] * 100%|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.|||percent predicted DLco||Standard Deviation|Mean
1295519|NCT00080223|Secondary|Percent Predicted Forced Vital Capacity (FVC)|FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) * 100%|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.|||percent predicted FVC||Standard Deviation|Mean
1295520|NCT00080223|Primary|Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.|Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)|All treated participants|||percentage of participants|||Number
1295521|NCT00002540|Secondary|T5 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T5 (five years after entry)|All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed.|||Participants|||Number
1295522|NCT00002540|Secondary|T4 PSA Screening Result|Prostate-Specific Antigen (PSA) result|T4 (four years after entry)|All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed.|||Participants|||Number
1295523|NCT00002540|Primary|Prostate Cancer Death Rates|Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.||||Deaths per 10,000 PY|||Number
1295524|NCT00002540|Secondary|T3 DRE Screening Results|Digital Rectal examination (DRE) result|T3 (three years after entry)|All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed.|||Participants|||Number
1295525|NCT00002540|Secondary|T3 PSA Screening Results|Prostate-Specific Antigen (PSA) result|T3 (three years after entry)|All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed.|||Participants|||Number
1295526|NCT00002540|Secondary|T2 DRE Screening Results|Digital Rectal Examination (DRE) results|T2 (two years after entry)|All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed.|||Participants|||Number
1295527|NCT00002540|Secondary|T2 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T2 (two years after entry)|All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed.|||Participants|||Number
1295528|NCT00002540|Secondary|T1 DRE Screening Results|Digital Rectal Examination (DRE) result.|T1 (one year after entry)|All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed.|||Participants|||Number
1295529|NCT00002540|Secondary|T1 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T1 (one year after entry)|All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed.|||Participants|||Number
1295530|NCT00002540|Secondary|T0 (Baseline) DRE Screening Results|Digital Rectal Examination (DRE) result.|T0 (at study entry)|All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed.|||Participants|||Number
1295531|NCT00002540|Secondary|T0 (Baseline) PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T0 (at study entry)|All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed.|||Participants|||Number
1295532|NCT00002540|Secondary|Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test|Number of positive screens with complications|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.|||Positive screens w/ complications|Positive Screens with Follow-up||Number
1295533|NCT00002540|Secondary|Prostate Cancer Incidence Rates|Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.|||Diagnoses per 10,000 PY|||Number
1295534|NCT00002540|Secondary|Prostate Cancer Incidence|Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1295535|NCT00002540|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009.|All male participants were analyzed. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
1295601|NCT00079183|Secondary|Proportion of Patients Who Discontinue Administration of Sirolimus Because of Toxicity||Approximately 7 years||||Participants|||Count of Participants
1295538|NCT00080119|Secondary|Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Any event of grade 3 or higher not present at entry that occurred after randomization was classified as a new event. Results report percent of participants with a new event by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting treatment. Time from randomization to first new adverse event (AE) calculated. For lab toxicities, censored at visit following permanent discontinuation of study drugs. For signs/symptoms, participants in follow-up at 96 wks (+12) with no new grade >=3 AE censored at 96 wks. Participants LTF <96 wks censored at LTF.|||Percent of participants|||Number
1295539|NCT00080119|Secondary|Time From Randomization to Death Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Deaths from any cause were included. Results report percent of participants dying by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to death was calculated. Participants LTF <96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks (+12 wks) censored at 96 weeks. HIVpos on study when study was discontinued were censored at their discontinuation visit.|||Percent of participants|||Number
1295540|NCT00080119|Secondary|Time From Randomization to Development of TB Infection Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to development of TB infection was calculated. Participants LTF <96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB infection were censored at 96 wks. HIVpos on study when study discontinued censored at their discontinuation visit.|||Percent of participants|||Number
1295541|NCT00080119|Secondary|Time From Randomization to Development of TB Disease Among HIV Infected and Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to development of TB disease was calculated. Participants LTF <96 wks (+12 wks) censored at time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. HIVpos on study when study discontinued were censored at their discontinuation visit.|||Percent of participants|||Number
1295542|NCT00080119|Secondary|Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVneg who started study treatment. Time from randomization to the first of TB disease/death was calculated. Participants lost-to-follow-up before 96 weeks (+12 week window)were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks who were free of TB disease were censored at 96 weeks (+12 week window).|||Percent of participants|||Number
1295543|NCT00080119|Secondary|Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children|HIV disease progression was defined as any advancement in Centers for Disease Control (CDC) disease category from entry or death. If a participant was CDC disease category C at entry progression was defined as death. Results report percent of participants with HIV progression or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVpos starting study treatment. Time from randomization to first of disease progression/death calculated. Censored if LTF <96 wks, at 96 wks (if on study) or at discontinuation visit. Participants found to be HIVneg upon repeat testing could only progress by meeting a death endpoint.|||Percent of participants|||Number
1295544|NCT00080119|Secondary|Time From Randomization to Development of TB Infection or Death Among HIV-infected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|HIVpos starting study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants LTF <96 weeks (+12 wk) censored at the time LTF. Participants in follow-up at 96 wks free of TB infection censored at 96 wks. Participants on study when study discontinued were censored at discontinuation visit.|||Percent of participants|||Number
1295545|NCT00080119|Primary|Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive tuberculin skin test (TST) based on a purified protein derivative (PPD) performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|HIVneg who started study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants lost-to-follow-up before 96 wks were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks (+12 week window) who were free of TB infection were censored at 96 weeks (+12 week window).|||Percent of participants|||Number
1295546|NCT00080119|Primary|Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children|Criteria for diagnosis with TB disease: Definite-isolation of Mycobacterium TB (M.tb) or +ve stain on cerebrospinal fluid (CSF); Probable- +ve acid fast bacilli (AFB) stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of pulmonary TB (PTB) and either a +ve tuberculin skin test (TST) or minimum score on algorithm for clinical TB. Records reviewed by Endpoint Review Group. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVpos who started study treatment. Time from randomization to TB disease/death was calculated. Participants lost-to-follow-up (LTF) <96 wks (+12wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. Participants on study when study discontinued censored at discontinuation visit.|||Percent of participants|||Number
1295547|NCT00079937|Primary|Percentage of Participants With at Least 1 Adverse Event|See Adverse Events module for details.|Baseline to end of the study (Week 68)|Safety population: All patients who received any study drug and had at least 1 post-baseline safety assessment.|||Percentage of participants|||Number
1295548|NCT00079937|Secondary|Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)|PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates.|Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1295549|NCT00079937|Secondary|Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period|Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication.|Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Puffs||Standard Deviation|Mean
1295550|NCT00079937|Secondary|Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period|A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period.|Baseline to end of the treatment period (Week 52)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Exacerbations per patient per year||95% Confidence Interval|Mean
1295551|NCT00079937|Primary|Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period|A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient’s person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period.|Baseline to end of the fixed-dose steroid treatment period (Week 24)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Exacerbations per patient per 24-weeks||95% Confidence Interval|Mean
1295552|NCT00079937|Secondary|Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period|Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question “How did you sleep last night?”, with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement.|Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Units on a scale||Standard Deviation|Mean
1295553|NCT00009737|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to Week 29|The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment|||Participants|||Number
1295554|NCT00009737|Secondary|Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters|Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.|Up to Week 25|The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.|||Participants|||Number
1295555|NCT00009737|Secondary|Mean Change From Baseline in Global Health Status at Week 25|Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.|Baseline (Days -7 to 1) and at Week 25|The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).|||Score on a scale||Standard Error|Mean
1295556|NCT00009737|Secondary|Overall Survival|Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.|||Participants|||Number
1295557|NCT00009737|Secondary|Relapse-Free Survival|Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.|||Participants|||Number
1295558|NCT00009737|Primary|Disease-free Survival|Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.|||Participants|||Number
1295559|NCT00079781|Primary|Responder Rate|"Percentage of subjects with a 50% or greater reduction in mean seizure frequency during the post-implant Evaluation Period (4 months or 112 days) compared to pre-implant baseline (collected during the Prospective Seizure Frequency study). The primary effectiveness endpoint would be met with an observed responder rate of 13% or more.~The effectiveness endpoint was only calculated for the Treatment Population. The endpoint was used to support a Pivotal Study, not to demonstrate efficacy when compared to a control/sham group.~The primary effectiveness endpoint was met."|Pre-implant baseline through 4 months post-implant||||Percent of participants|||Number
1295560|NCT00079781|Primary|Short-term Chronic SAE Rate|"The RNS® System Short-term Chronic SAE rate = the percentage of implanted subjects having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 46%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.~The primary safety outcome measure was met."|Initial implant through 3 months post-implant||||percentage of participants||95% Confidence Interval|Number
1295561|NCT00079781|Primary|Acute SAE Rate|"RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.~The primary safety outcome measure was met."|Initial implant through 1 month post-implant||||percentage of participants||95% Confidence Interval|Number
1295562|NCT00079677|Primary|Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|12 weeks or last post-baseline visit|"Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug.~Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy."|||Participants|||Number
1295602|NCT00079183|Primary|Number of Participants With Recurrent Malignancy|Defined as clinical or histopathologic evidence demonstrating the presence of any malignancy considered as the indication for transplant. Recurrent malignancy will also be defined as any post-transplant intervention not routinely used to prevent the development of overt recurrence, prompted by laboratory evidence of persisting malignant cells but without clinical or histopathologic evidence of recurrence.|Approximately 7 years||||Participants|||Count of Participants
1295563|NCT00079677|Primary|Maintenance of Wakefulness Test (MWT)|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).|Change from baseline at 12 weeks or early termination|"Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug.~Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy."|||Minutes||Standard Deviation|Mean
1295564|NCT00002601|Secondary|5-year Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years||||percentage of participants||95% Confidence Interval|Number
1295565|NCT00002601|Secondary|5-year Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 25% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|Until disease progression, up to 5 Years||||percentage of participants||95% Confidence Interval|Number
1295566|NCT00002601|Primary|Toxicities Counts|Number of patients with grade 3 and 4 toxicities observed during cycles 1 & 2 using the Common Toxicity Criteria Version for Chemotherapy.|2 months after completion of second cycle of treatment.||||Participants|||Count of Participants
1295567|NCT00002601|Primary|Number of Participants With Grade 3 Bilirubin|Criteria for early termination of this feasibility study: > 2 patients experience grade 4 or 5 hematologic toxicity or more that 3 patients experience grade 3 hematologic toxicity; > 2 patients experience grade 3 hepatic or gastrointestinal toxicity or > 3 patients are unable to receive the second cycle of treatment; > 2 patients experience grade 5 toxicity related to treatment regimen.|2 years after completion of treatment||||participants with Grade 3 Bilirubin|||Number
1295568|NCT00079417|Secondary|Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0|Participants with Grade 3 and higher reported on protocol therapy|6 months after enrollment|All eligible patients are reported. 7 patients were excluded due to ineligible status.|||Participants|||Number
1295569|NCT00079417|Secondary|Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level|EFSR will be estimated for patients who respond to vincristine and carboplatin after an initial 1 cycle of chemoreduction|2 years after enrollment|There were 15 eligible patients who responded to vincristine and carboplatin after an initial 1 cycle of therapy. 7 patients were excluded due to ineligible status.|||Proportion of participants||95% Confidence Interval|Number
1295570|NCT00079417|Secondary|Response Rate (RR) at Eye Levels After the First Course of Therapy|RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number eyes with Type I, II, III or IV response after first course of therapy|1 month after enrollment|Number of Group B eyes for the eligible patients. 4 patients were excluded due to ineligible status.|||Proportion of eyes||95% Confidence Interval|Number
1295571|NCT00079417|Secondary|Response Rate (RR) at Patient Level After the First Course of Therapy|RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number of patients with Type I, II, III or IV response after first course of therapy|1 month after enrollment|All eligible patients are reported. 7 patients were excluded due to ineligible status.|||Proportion of participants||95% Confidence Interval|Number
1295572|NCT00079417|Primary|Event-free Survival|Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy.|At 2 years|All eligible patients are reported. 7 patients were excluded due to ineligible status. Of the 7 patients, 1 was determined to have only a Group A involved eye and the other 6 had an intact eye that was Group C or D.|||Proportion of participants||95% Confidence Interval|Number
1295573|NCT00079391|Secondary|Acute GVHD Overall|Incidence of acute GVHD grades II-IV (before and after T cell add back) Modified Glucksberg grading|First 100 days||||participants|||Number
1295574|NCT00079391|Secondary|Acute Graft Versus Host Disease (Before Day 60 T Cell Add Back)|"Incidence of acute Graft versus host disease (GVHD) grades II-IV (before day 60 T cell add back)~Modified Glucksberg grading"|First 60 days|Per protocol|||participants|||Number
1295575|NCT00079391|Secondary|Cumulative Incidence of Relapse|Kaplan Meier-estimate of relapse incidence|at 5 years post transplant||||percentage of participants|||Number
1295576|NCT00079391|Secondary|Non Relapse Mortality.|"Non relapse mortality: death without relapse~Kaplan Meier estimate"|at 5 years post transplant||||percentage of participants|||Number
1295577|NCT00079391|Secondary|Overall Survival|Kaplan Meier estimate of survival|at 5 years post transplant||||percentage of participants|||Number
1295578|NCT00079391|Primary|The Proportion of Patients Who Develop Full Donor T Cell Chimerism at Day 30|"The proportion of patients who develop full donor CD3+ lymphocyte chimerism by day 30.~Full chimerism is defined as >95% donor alleles by molecular profiling (Short Tandem Repeat analysis)."|Day 30|Per protocol; only patients who survived to day 30 and were evaluable.|||percentage of participants|||Number
1295603|NCT00079183|Primary|Number of Participants Needing Additional Systemic Therapy|Includes any intervention intended to control chronic GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not originally given under auspices of this protocol.|Approximately 7 years||||Participants|||Count of Participants
1295604|NCT00079183|Primary|Number of Participants Experiencing Treatment Failure|Defined as the initiation of additional systemic therapy, development of bronchiolitis obliterans, or death from causes other than recurrent malignancy during primary treatment for chronic GVHD, whichever occurs first.|Approximately 7 years||||Participants|||Count of Participants
1295579|NCT00079339|Secondary|Mean Tumor to White Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/white matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.|Baseline|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.|||Ratio||Full Range|Median
1295580|NCT00079339|Secondary|Mean Tumor to Gray Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.|Baseline|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.|||Ratio||Full Range|Median
1295581|NCT00079339|Secondary|Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline and within two weeks after completion of radiation.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline volume FLAIR value and a second volume FLAIR value measured at approximately 8 weeks after starting treatment.|||cubic centimeters||Full Range|Median
1295582|NCT00079339|Secondary|Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation.|This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Diffusion values are obtained from magnetic resonance diffusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline diffusion ratio value and a second diffusion ratio value measured at approximately 8 weeks after starting treatment.|||Ratio||Full Range|Median
1295583|NCT00079339|Secondary|Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Perfusion values are obtained from magnetic resonance perfusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline perfusion ratio value and a second perfusion ratio value measured at approximately 8 weeks after starting treatment.|||Ratio||Full Range|Median
1295584|NCT00079339|Primary|Progression-free Survival (PFS)|PFS was defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.|Assessed before the first dose of tipifarnib, every 8 weeks for the first 48 weeks, and then every 12 weeks.|Per protocol 40 participants who received at least one dose of tipifarnib were needed for this objective. The analysis population consists of phase I participants treated at the maximum tolerated dose (MTD) and the participants enrolled to the phase II part.|||Months||Full Range|Median
1295585|NCT00079339|Primary|Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy|The dose limiting toxicity (DLT) analysis population consists of phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD.|Day 1 of tipifarnib therapy to week 8|Per protocol, participants included phase I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.|||Participants|||Number
1295586|NCT00079326|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure as determined by RECIST v.1.0 Criteria: is the time from the date of randomization or start of treatment to the earliest date of progression, date of death due to any cause, or date of discontinuation due to reasons of adverse events, abnormal laboratory values, abnormal test procedure results, subject withdraws consent, or date 'Lost to follow up'.|up to 6 years||||months||95% Confidence Interval|Median
1295587|NCT00079326|Primary|Overall Response Rate|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
1295605|NCT00079183|Primary|Number of Participants Experiencing Treatment Success|Defined as the absence of any immunosuppressive treatment, including sirolimus, with resolution of all reversible manifestations of chronic GVHD and no additional systemic therapy.|Approximately 7 years||||Participants|||Count of Participants
1295606|NCT00079040|Secondary|Best Objective Response|Number of patients with complete or partial response by RECIST criteria.|Assessed every 6 weeks|Per protocol, the analysis included all eligible, treated patients.|||Patients Responding|||Number
1295588|NCT00079274|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Mutant KRAS Patients)|The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.|Assessed up to 8 years|All patients that were mutant KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule and completed the adverse event form at least once were evaluated for this endpoint.|||percentage of patients|||Number
1295589|NCT00079274|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients)|The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.|Assessed up to 8 years|All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule and completed the adverse event form at least once were evaluated for this endpoint.|||percentage of patients|||Number
1295590|NCT00079274|Secondary|Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients)|Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event-free rates (percentage) are report below for mutant KRAS patients.|Up to 3 years|The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.|||percentage of participants||95% Confidence Interval|Number
1295591|NCT00079274|Secondary|Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients)|Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event free rates (percentage) are reported below for Wild-type KRAS Patients.|Up to 3 years|The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.|||percentage of participants||95% Confidence Interval|Number
1295592|NCT00079274|Secondary|Disease-free Survival (Arms A and D: Mutant KRAS Patients)|"A secondary endpoint for this study was to investigate the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.~Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier."|At 3 years|The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.|||percentage of participants||95% Confidence Interval|Number
1295593|NCT00079274|Primary|Disease-free Survival (Arms A and D: Wild-type KRAS Patients)|"The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.~Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier."|At 3 years|The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.|||percentage of participants||95% Confidence Interval|Number
1295594|NCT00079183|Secondary|Probability of Cumulative Incidence of Recurrent Malignancy|Analyzed with death as a competing risk factor. Assessed at 7 years.|Approximately 7 years||||probability||95% Confidence Interval|Number
1295595|NCT00079183|Secondary|Probability of Cumulative Incidence of Death Without Recurrent Malignancy|Analyzed with recurrent malignancy as a competing risk factor. Assessed at 7 years.|Approximately 7 years||||probability||95% Confidence Interval|Number
1295596|NCT00079183|Secondary|Probability of Overall Survival|Kaplan-Meier estimate assessed at 7 years|Approximately 7 years||||survival probability||95% Confidence Interval|Number
1295597|NCT00079183|Secondary|Probability of Survival Without Recurrent Malignancy|Kaplan-Meier estimate assessed at 7 years for probability of survival without recurrent malignancy.|Approximately 7 years||||disease free survival probability||95% Confidence Interval|Number
1295598|NCT00079183|Secondary|Duration of Treatment With Prednisone||Approximately 7 years||||Months||Full Range|Mean
1295607|NCT00079040|Secondary|Overall Survival|Overall survival is defined as the time from registration to death or date last known alive. Patients alive at last follow-up are censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|Per protocol, the analysis included all eligible, treated patients|||months||95% Confidence Interval|Median
1295608|NCT00079040|Primary|Percentage of Participants Alive and Progression-free (PF) at 6 Months|Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.|6 months|Per protocol, the analysis included all eligible, treated patients (n=63). The safety analysis included all treated patients, regardless of eligibility (n=64).|||Percentage of Participants||95% Confidence Interval|Mean
1295609|NCT00079001|Secondary|Progression-free Survival|"Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.~Progression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment."|Up to 10 years||||months||95% Confidence Interval|Median
1295610|NCT00079001|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 10 years||||months||95% Confidence Interval|Median
1295611|NCT00079001|Primary|Time to First Skeletal Related Event|Time to first skeletal related event (SRE) was defined as the time from randomization to first skeletal event. Skeletal events are defined as radiation to bone, clinical fracture, surgery to bone and spinal cord compression and death due to prostate cancer. The median with 95% CI was estimated using the Kaplan Meier method.|Up to 10 years||||months||95% Confidence Interval|Median
1295612|NCT00078949|Secondary|Toxicity Assessed by NCI CTC v2.0 for 2 Years in Patients on Treatment Arm II||10 years|||||||
1295613|NCT00078949|Secondary|Mobilization Rate of Patients on Treatment Arm I Assessed by CD34 Count After 2 Courses of Therapy and Stem Cell Harvesting||10 years|||||||
1295614|NCT00078949|Primary|Event-free Survival of Patients on Maintenance Randomization (Period 2)|Number of patients who develop EFS event during maintenance randomization (period 2)|during the period 2 (up to10 years)|ITT population|||participants|||Number
1295615|NCT00078949|Primary|Transplantation Rate of Patients After 2 Courses of Chemotherapy|Transplantation rate is defined as the number of patients who respond sufficiently to protocol salvage chemotherapy to be planned for transplantation minus those who do not meet the endpoint of successful transplantation, divided by the number of all randomized patients|During period 1 (salvage chemotherapy)||||percentage of transplantation|||Number
1295616|NCT00078949|Primary|Response Rate of Patients After 2 Courses of Chemotherapy|The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).|After 2 cycle of treatment|ITT population|||percentage of response|||Number
1295617|NCT00078767|Secondary|Incidence of Suicidality|Change in degree of suicidal ideation during study|Up to 39 months||||Participants|||Count of Participants
1295618|NCT00078767|Secondary|Global Impairment|Change in Children's Global Assessment Scale (CGAS) between the two groups|Up to 39 months|There were two categories of depression: participants that had clinical signs of impairment at the time of enrollment as evidenced by their CGAS scores, and participants that did not have clinical signs of depression. Participants clinical symptoms were tested to see if their status changed during the trial.|||Participants|||Count of Participants
1295619|NCT00078767|Secondary|Anxiety Symptoms|"Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the clinical symptom present at enrollment category were tested to see if their status changed during the trial."|Up to 39 months|There were two categories of anxiety symptoms: participants that had clinical signs of anxiety at the time of enrollment as evidenced by their SCARED scores, and participants that did not have clinical signs of depression. Participants with clinical symptoms category were tested to see if their status changed during the trial.|||Participants|||Count of Participants
1295620|NCT00078767|Secondary|Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms|Change in depressive symptoms as determined by change in score|Up to 39 months|"There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the clinical symptom present at enrollment category were tested to see if their status changed during the trial."|||Participants|||Count of Participants
1295621|NCT00078767|Primary|Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD|Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.|Up to 39 months||||Participants|||Count of Participants
1295622|NCT00078754|Secondary|Treatment Response, Assessed as a Function of the Severity of Lifetime Aggressiveness of the Participant and as a Function of the Pretreatment Status of the Central 5-HT Receptor System||Measured at Week 12|||||||
1295623|NCT00078754|Primary|Overt Aggression Scale-Modified (OAS-M)|OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.|Measured at Week 12||||units on a scale||Standard Error|Mean
1295867|NCT00075829|Secondary|Cumulative Incidence of Treatment Related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression.|Year 3|Patients that completed second transplant|||percentage of participants||95% Confidence Interval|Number
1295624|NCT00078728|Primary|Child Anxiety Diagnoses|The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.|12 months||||participants|||Number
1295625|NCT00078728|Primary|Number of Children With Child Anxiety Diagnosis|Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.|12 month||||participants|||Number
1295626|NCT00078715|Secondary|To Determine Whether Measures Previously Demonstrated to be Predictive of Response to Sleep Deprivation & Noradrenergically Mediated Will be Assoc With Response to Yohimbine When Administered During REM Sleep.||2-4 weeks|||||||
1295627|NCT00078715|Primary|Hamilton Depression Rating Scale (6 Items)|The 6 item Hamilton Depression Rating Scale is a measurement of the severity of depression with a range of scores from 0 to 24, where 24 indicates the most severe depression.|Once per day, where the primary comparison involves an average over the full study after controlling for baseline||||Units on a scale||Standard Error|Mean
1295628|NCT00005947|Secondary|Overall Survival|Overall Survival|From randomization to 36 months||||Months||95% Confidence Interval|Median
1295629|NCT00005947|Primary|Time to Objective Disease Progression|The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).|36 months from randomization|all randomized participants|||Weeks||95% Confidence Interval|Median
1295630|NCT00078559|Secondary|Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status|Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 – 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||mg/dL||Standard Deviation|Mean
1295631|NCT00078559|Secondary|Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status|Side effects of conventional immunosuppression include increased body weight and hypertension|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||side effects|||Number
1295632|NCT00078559|Secondary|Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||adverse events|||Number
1295633|NCT00078559|Secondary|Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||adverse events|||Number
1295634|NCT00078559|Secondary|Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||adverse events|||Number
1295635|NCT00078559|Secondary|Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status|"Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy~1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to four years post-transplantation)|Intent-to-treat|||participants|||Number
1295636|NCT00078559|Secondary|Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status|"Participants who experienced severe acute rejections[1] during study~Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to severe acute rejection (up to four years post-transplantation)|Intent-to-treat|||Rejection Events|||Number
1295637|NCT00078559|Secondary|Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status|"Participants who experienced graft loss[1] during study~[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation"|Transplantation to Graft Loss (up to four years post-transplantation)|Intent-to-treat|||participants|||Number
1295638|NCT00078559|Secondary|Number of Deaths Stratified by Sirolimus Withdrawal Status|Participants who died during the study, all cause(s)|Transplantation to Death (up to four years post-transplant)|Intent-to-treat|||deaths|||Number
1295639|NCT00078559|Secondary|Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period|"Time (days) to acute rejection[1] for participants occurring during the year following transplantation~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to one year post-transplant)|Participants with acute rejections for whom sirolimus withdrawal was not initiated|||Days|||Number
1295640|NCT00078559|Secondary|Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated|"Time (days) to acute rejection[1] for participants where sirolimus was not initiated~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to four years post-transplantation)|Participants for whom sirolimus withdrawal was not initiated|||Days|||Number
1295877|NCT00075816|Secondary|Current Immunosuppressive (IS) Free Survival|This outcome measure takes into account subsequent immunosuppressive therapy that may occur following discontinuation of initial immunosuppressive therapy.|Measured at 2 years|No data collected.||||||
1295641|NCT00078559|Secondary|Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study|"Acute rejections[1] between initiation of sirolimus withdrawal and end of study~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Initiation of sirolimus to end of study (up to four years post-transplant)|Sirolimus withdrawal initiation participant sample|||Rejection Events|||Number
1295642|NCT00078559|Secondary|Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal|"Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||Rejection Events|||Number
1295643|NCT00078559|Primary|Number of Acute Rejections in All Enrolled Participants|"Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)~Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Four years post-transplant|Intent-to-treat|||Rejection Events|||Number
1295644|NCT00002597|Secondary|Positive Re-biopsy Rate at Two Years|The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm.|From registration to two years|All eligible patients who had a repeat biopsy at 2 years.|||percentage of participants|||Number
1295645|NCT00002597|Secondary|Disease-free Survival Rate (10 Years)|Disease-free failure is defined as documentation of progression (local progression, distant failure, and biochemical failure) or death from any cause. Disease-free survival rates were estimated by the Kaplan-Meier method.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1295646|NCT00002597|Secondary|Second Biochemical Relapse Rate (10 Years)|Second biochemical relapse is as defined as follows (after initiation of salvage hormone therapy): A rise in PSA on at least two consecutive cases above the nadir (after initiation of salvage hormone therapy), with the rises in PSA exceeding 1 ng/ml above the nadir; or failure to reach 4 ng/L or less at 18 months. The rates of second biochemical relapse were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1295647|NCT00002597|Secondary|Clinical Relapse Rate (10 Years)|Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1295648|NCT00002597|Secondary|Biochemical Failure Rate (10 Years)|The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of >2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1295649|NCT00002597|Secondary|Distant Failure Rate (10 Years)|Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1295650|NCT00002597|Secondary|Local Progression Rate (10 Years)|Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1295651|NCT00002597|Secondary|Disease-specific Survival Rate (10 Years)|Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1295652|NCT00002597|Primary|Overall Survival Rate (10-year)|Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan–Meier method.|From date of randomization to 10 years|All eligible patients.|||percentage of patients||95% Confidence Interval|Number
1295653|NCT00078377|Primary|Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|change from baseline at 12 weeks|"Safety Analysis set of 194 total patients (received at least 1 dose of study drug): 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).~Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy analysis."|||Participants|||Number
1295667|NCT00078403|Secondary|HCV Polymorphisms|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.|Entry and week 72 (Arms A and B only).|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.||||||
1295654|NCT00078377|Primary|Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).|change from baseline at 12 weeks|"Safety Analysis set of 194 total patients: 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).~Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy."|||Minutes||Standard Deviation|Mean
1295655|NCT00078338|Primary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.|Baseline up to 96 weeks|The ITT population consisted of all subjects who were randomized.|||days||Standard Deviation|Mean
1295656|NCT00076687|Secondary|Change From Baseline in Ashworth Scale|Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement.|Baseline, Week 6|Intent to Treat|||Number on a scale||Standard Deviation|Mean
1295657|NCT00076687|Secondary|Change From Baseline in FEV1/FVC Ratio|Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second.|Baseline, Week 6|Safety|||Ratio||Standard Deviation|Mean
1295658|NCT00076687|Primary|Change From Baseline in Forced Expiratory Volume (FEV1)|Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.|Baseline, Week 6|Safety|||Liters of air||Standard Deviation|Mean
1295659|NCT00076687|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.|Baseline, Week 6|Safety|||Liters of air||Standard Deviation|Mean
1295660|NCT00078403|Secondary|Weight|Participant weight in kilograms.|Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.|All Arm A, B and C participants who had weight available. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.|||kilograms||Inter-Quartile Range|Median
1295661|NCT00078403|Secondary|Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)|Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment|At any time after pre-assignment|All Arm A, B and C participants|||Participant|||Number
1295662|NCT00078403|Secondary|Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol|Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
1295663|NCT00078403|Secondary|Sustained Virologic Response|Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (<60 IU/ml) 24 weeks after treatment discontinuation.|24 weeks after end of treatment|All Arm A, B and C participants|||Participant|||Number
1295664|NCT00078403|Secondary|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Insulin resistance was evaluated by HOMA-IR, calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.|Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.|All Arm A, B and C participants who had HOMA-IR result available. In Arm C, metabolic testing was only performed on participants who enrolled under protocol version 1.0. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.|||mg/dL x uIU/mL||Inter-Quartile Range|Median
1295665|NCT00078403|Secondary|Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)|A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as <50 copies/mL (undetectable) or >=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.|Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84|All Arm A, B, and C participants|||Participant|||Number
1295666|NCT00078403|Secondary|HCV-specific Immune Response in Intrahepatic Lymphocytes|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.|Entry and week 72 (Arms A and B only).|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.||||||
1295878|NCT00075816|Secondary|Acute GVHD Grade III-IV||100 days, 180 days||||percentage of patients||95% Confidence Interval|Number
1295879|NCT00075816|Secondary|Acute GVHD Grade II-IV||100 days, 180 days||||percentage of patients||95% Confidence Interval|Number
1295668|NCT00078403|Secondary|Number of Participants Adherent to Study Medications|A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit.|Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.|All Arm A and Arm C participants. Arm B participants did not receive treatment.|||Participant|||Number
1295669|NCT00078403|Secondary|Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations|3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.|Up to 96 Weeks|All Arm A and C participants. Arm B participants did not receive treatment.|||Participant|||Number
1295670|NCT00078403|Secondary|Number of Participants With High-grade Signs and Symptoms or Laboratory Values|Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.|Up to 96 Weeks|All Arm A, B and C participants|||Participant|||Number
1295671|NCT00078403|Secondary|Number of Participants With Depression and/or Other Psychological Events|Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
1295672|NCT00078403|Secondary|Number of Participants With Thrombocytopenia|Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm^3; Grade 2 = 50,000 to 74,999 /mm^3; Grade 3 = 20,000 to 49,999 /mm^3; Grade 4 = below 20,000 /mm^3.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
1295673|NCT00078403|Secondary|Number of Participants With Neutropenia|Number of participants with neutropenia by grade (defined by absolute neutrophil count [ANC] per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm^3; Grade 2 = 750 to 999 /mm^3; Grade 3 = 500 to 749 /mm^3; Grade 4 = below 500 /mm^3.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
1295674|NCT00078403|Secondary|Number of Participants With Anemia|Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
1295675|NCT00078403|Secondary|Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)|Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.|Baseline and at week 72 or premature discontinuation|All participants with SCIIS available (Complete Cases)|||Ishak units per one year (52 weeks)||Inter-Quartile Range|Median
1295676|NCT00078403|Secondary|Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)|Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3.|Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84|All Arm A, B and C participants|||Participant|||Number
1295677|NCT00078403|Primary|Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)|SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).|Baseline and at week 72 or premature discontinuation|62 Arm A and B participants who had follow-up liver biopsy performed or those who had Week 72 potential as of May 2, 2007 but no follow-up liver biopsy. In the unadjusted ITT analysis, the participants without SCMFS available were assigned the highest SCMFS (+2).|||Metavir units per one year (52 weeks)||Inter-Quartile Range|Median
1295678|NCT00078325|Primary|Clinical Global Impression of Change (CGI-C)|The CGI-C represents a subjective measure of the patient’s global health (clinician’s rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|change from baseline at 12 weeks|Safety Analysis set of 392 total patients (ITT): 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)|||Participants|||Number
1295679|NCT00078325|Primary|Maintenance of Wakefulness Test (MWT)|The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.|change from baseline at 12 weeks|"Safety Analysis set of 392 total patients: 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)~Full Analysis set of 365 total patients: 27 patients that had withdrawn from the study were non-evaluable for efficacy."|||Minutes||Standard Deviation|Mean
1295720|NCT00077649|Secondary|Percentage of Participants With Sustained Virological Response|SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.|Week 72|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants||95% Confidence Interval|Number
1295680|NCT00078312|Primary|Safety and Tolerability as Measured by Number of Participants With Adverse Events|Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.|Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter|Safety Analysis set of 323 total patients: 5 participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant)|||Participants|||Number
1295681|NCT00078286|Secondary|Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.|Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.|Measured at Week 12|Analysis was based on intent to treat (ITT).|||percentage of participants|||Number
1295682|NCT00078286|Primary|Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo|"Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.~The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period."|Measured at Week 12|Analysis was based on intent to treat (ITT), using random coefficient modeling.|||HDRS Change Score||Standard Deviation|Mean
1295683|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
1295684|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
1295685|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
1295686|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite|Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
1295687|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib Metabolite|Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
1295688|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib|Observed plasma trough (predose) (Cmin) concentrations of sunitinib|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
1295689|NCT00077974|Secondary|Percent Chance of Patient Survival|Probability of survival 1 year and 2 years after the first dose of study treatment|From start of study treatment until death|ITT|||percent chance of survival|||Number
1295690|NCT00077974|Secondary|Progression-free Survival (PFS)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was “Death”).|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death|ITT|||weeks||95% Confidence Interval|Median
1295691|NCT00077974|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).|From start of study treatment until death|ITT|||weeks||95% Confidence Interval|Median
1295692|NCT00077974|Secondary|Duration of Response (DR)|"Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.~DR was calculated for the subgroup of patients with a confirmed objective tumor response."|Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer|ITT subgroup of patients with a confirmed objective tumor response|||weeks||95% Confidence Interval|Median
1295880|NCT00075816|Secondary|Grades III-V Unexpected Adverse Events||Measured by 2 years||||participants|||Number
1295693|NCT00077974|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter|ITT|||weeks||95% Confidence Interval|Median
1295694|NCT00077974|Primary|Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)|Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter|The intent-to-treat (ITT) population included all subjects who enrolled in the study that received at least 1 dose of study medication. This was the primary population for all efficacy analyses and safety analyses.|||participants|||Number
1295695|NCT00077857|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~Additional information about Adverse Events can be found in the Adverse Event Section."|First study drug intake until last study drug intake plus 28 days|Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m^2 actual received an initial dose that ranged from 480 to 984 mg/m^2 so are included in the 825 mg/m^2 arm for safety.|||Participants|||Number
1295696|NCT00077857|Secondary|Overall Survival|Overall Survival was measured as the time from the date of randomization to the date of death.|Throughout the study. Median observation time was approximately 16 months.|Intent to treat population included all randomized participants.|||Months||95% Confidence Interval|Median
1295697|NCT00077857|Secondary|Time to Treatment Failure|"The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events:~adverse events~insufficient therapeutic response (disease progression)~death~failure to return~refusing treatment/being unwilling to cooperate~withdrawing consent."|Until premature withdrawal or end of primary study treatment (up to 16 cycles).|Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m^2 actual received an initial dose that ranged from 480 to 984 mg/m^2 so are included in the 825 mg/m^2 arm for safety.|||Months||95% Confidence Interval|Median
1295698|NCT00077857|Secondary|Duration of Overall Response|Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented.|Until PD or death. Median duration of response was approximately 7 months.|Intent to treat population included all randomized participants.|||Months||95% Confidence Interval|Median
1295699|NCT00077857|Secondary|Time to Overall Response|For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported.|Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.|Intent to treat population included all randomized participants.|||Percentage of participants|||Number
1295700|NCT00077857|Secondary|Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)|According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD.|Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.|Intent to treat population included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1295701|NCT00077857|Primary|Time to Progression of Disease or Death|Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.|Event driven (after 350 events). Median observation time was approximately 16 months.|Per protocol population included all participants who received at least one dose of study and who did not have any major protocol deviations.|||Months||95% Confidence Interval|Median
1295702|NCT00077766|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths|An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.|Up to Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.|||Participants|||Number
1295703|NCT00077766|Secondary|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52|Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.|Baseline, Week 36, and Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).|||beats per minute||Standard Deviation|Mean
1295704|NCT00077766|Secondary|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52|Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).|Baseline, Week 36, and Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
1295705|NCT00077766|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0– 18.0 10^9/liter [L]), platelets (100 – 550 10^9/L), (alanine aminotransferase [(ALAT)] (0 – 110 units per liter [U/L]), alkaline phosphatase (ALP) (0 – 220 U/L), aspartate aminotransferase (ASAT) (0 – 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimole per liter [mmol/L]), potassium (2.9 – 5.8 mmol/L), glucose (2.80 – 11.10 mmol/L).|Up to Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time points were included in the analysis (n).|||Participants|||Number
1295706|NCT00077766|Secondary|Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods|A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).|Week 1 to Week 36|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.|||Participants|||Number
1295707|NCT00077766|Secondary|Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration|The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)|The Intent-to-Treat (ITT) population was defined as all randomized participants. Participants with available data at the time of evaluation were analyzed.|||Participants|||Number
1295708|NCT00077766|Primary|Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period|A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)|The per protocol population was all randomized and treated participants, except those who had not met criteria for stable baseline Hb,and adequate iron levels or had hemoglobinopathies/hemolysis, RBC transfusion/blood loss, <5 recorded Hb values during evaluation or missed administrations of trial drugs in week 26 to 35.|||gram per deciliter (g/dL)||Standard Deviation|Mean
1295709|NCT00077922|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|54 months||||Participants|||Number
1295710|NCT00077922|Primary|Response Rate|Response is measured by the 1996 National Cancer Institute (NCI) Working Group Criteria (NCIWG). Complete response is defined as no hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must resolve to <1.0cm of 1-1.5cm at baseline, or <1.5cm if >1.5cm at baseline. Partial response is >=50% decrease in peripheral blood lymphocytes count from the pretreatment baseline value. Progressive disease is >=50% increase in the sum of the products of the greatest perpendicular dimensions of a t least 2 lymph nodes on two consecutive examinations 2 weeks apart (at least 1 node must be >=2cm) or appearance of new palpable lymph nodes. Stable disease is characterized by not meeting the above criteria. For additional details about the NCIWG, see the protocol link module.|Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months.||||Participants|||Number
1295711|NCT00077675|Primary|Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|"Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.~Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit~Indeterminate: Inability to determine outcome."|7 to 14 days following completion of antibiotic treatment|"The CE population was a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population."|||participants|||Number
1295763|NCT00077064|Secondary|Correlation of Lung Toxicities With Biochemical Markers|Biomarker data will not be generated from these tissue specimens, therefore this analysis will not take place.|Once all patients have been followed for at least 12 months|||||||
1295881|NCT00075816|Secondary|Infections|Number of infection reports per patient.|Measured at 1 and 2 years|Analysis restricted to patients who received the transplant.|||participants|||Number
1295712|NCT00077649|Primary|Percentage of Participants With Predicted Sustained Virological Response|The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under “Distribution of the predicted probability of an SVR.”|Week 4 and 12|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants|||Number
1295713|NCT00077649|Primary|Percentage of Participants With Virological Response Over Time to Week 24|Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.|72 hours post-dose, Weeks 1, 2, 4, 12, and 24|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants||95% Confidence Interval|Number
1295714|NCT00077649|Secondary|Total BDI-II (Beck Depression Inventory) Scores|The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit.|From Baseline (Day 1) to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1295715|NCT00077649|Secondary|Percentage of Participants With Abnormal Vital Signs|Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline.|Up to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.|||percentage of participants|||Number
1295716|NCT00077649|Secondary|Percentage of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 – 20.0 (g/dL),platelets 100 – 700 (10^9/L), lymphocyte 1.00 – 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 – 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 – 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 – 50 (U/L), alkaline phosphatase 0 – 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 – 120 (U/L),Total protein 55 – 87 (g/L),total bilirubin 0 – 34.2 (μmol/L),BUN 0 – 14.3 (mmol/L),creatinine 0 – 154 (μmol/L),chloride 95 – 115 (mmol/L),potassium 3.0 – 6.0 (mmol/L), sodium 130 – 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 – 10.0 (mU/L),triglycerides 0.00 – 2.83 (mmol/L), calcium 2.00 – 2.90 (mmol/L),phosphate 0.75 – 1.60 (mmol/L),Blood Glucose 2.80 – 11.10 (mmol/L),Uric Acid 0 – 600 (μmol/L),proteinuria 0 – 1 (0 to 4+), glycosuria 0 – 1 (0 to 4+), hematuria 0 – 1 (0 to 4+).|Up to Week 60|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment where included in the analysis.|||percentage of participants|||Number
1295717|NCT00077649|Secondary|Percentage of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.|||percentage of participants|||Number
1295718|NCT00077649|Secondary|Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period|Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.|Week 60|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants||95% Confidence Interval|Number
1295719|NCT00077649|Secondary|Percentage of Participants With Virological Response at the End of the Treatment Period|Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.|Week 48|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants||95% Confidence Interval|Number
1295721|NCT00077649|Primary|HCV RNA Profile During The First 24 Weeks|Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).|Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||log 10 copies/mL||Standard Deviation|Mean
1295722|NCT00077636|Secondary|Number of Participants With Highest Triglyceride Level|Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.|Up to Week 40 and Week 48|The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.|||participants|||Number
1295723|NCT00077636|Secondary|Participants With Marked Abnormal Vital Signs|Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.|||participants|||Number
1295724|NCT00077636|Secondary|Percentage of Participants With Marked Laboratory Abnormalities|Participants with changes in Hematocrit: Fraction 0.36 – 0.60 g/dL, Hemoglobin: 11.0 –20.0 g/dL, WBC 3.0 – 18.0 g/dL, Platelets 100 – 700 g/dL, Basophils 0.00 – 0.30 g/dL, Lymphocytes 1.00 – 6.30 g/dL, Monocytes 0.08 – 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 – 1.50 g/dL , PTT 0 – 50 seconds, Alkaline Phosphatase 0 – 190 and ASAT 0 – 50 U/L, ALAT 0 – 60 U/L, Gamma – GT 0 – 120 U/L, Total Protein 55 – 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 – 34.2 μmol/L, BUN 0 – 14.3 mmol/L, Creatinine 0 – 154 μmol/L, Free T3, T4 5 – 40 pmol/L, TSH 0.0 – 10.0 mU/L, Cholesterol 0.0 – 8.3 mmol/L; Triglycerides 0.00 – 2.83 mmol/L, Chloride 95 – 115 mmol/L; Potassium 3.0 – 6.0 mmol/L; Sodium 130 – 150 mmol/L, miscellaneous: Calcium 2.00 – 2.90 mmol/L; Phosphate 0.75 – 1.60 mmol/L; Blood Glucose (Random) 2.80 – 11.10 mmol/L, Uric Acid 0 – 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 – 1 were analysed for the laboratory abnormality.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.|||Percentage of participants|||Number
1295725|NCT00077636|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.|||Percentage of participants|||Number
1295726|NCT00077636|Secondary|Percentage of Participants Virological Response 12 Weeks Post-Treatment|Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.|Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)|Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.|||Percentage of participants|||Number
1295727|NCT00077636|Secondary|Percentage of Participants With Virological Response at The End of Study Treatment|Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.|Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)|Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.|||Percentage of participants|||Number
1295728|NCT00077636|Primary|Percentage of Participants With Sustained Virological Response (SVR)|SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.|Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)|Standard population: The standard population includes all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.|||percentage of participants|||Number
1295729|NCT00077623|Secondary|Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants|Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.|||BpM||Standard Deviation|Mean
1295730|NCT00077623|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study medication. Maximum number of participants available at the time of assessment were analysed and reported.|||mm HG||Standard Deviation|Mean
1295784|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1295731|NCT00077623|Secondary|Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants|Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.|||BpM||Standard Deviation|Mean
1295732|NCT00077623|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.|||mmHG||Standard Deviation|Mean
1295733|NCT00077623|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0– 18.0 10^9/L), platelets (100 – 550 10^9/L), alanine aminotransferase (ALAT) (0 – 110 units per liter [U/L]), alkaline phosphatase (ALP [0 – 220 U/L]), aspartate aminotransferase (ASAT) (0 – 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter [mmol/L]), potassium (2.9 – 5.8 mmol/L), glucose (2.80 – 11.10 mmol/L).|Up to week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment were denoted as ‘n'.|||participants|||Number
1295734|NCT00077623|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to week 52|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
1295735|NCT00077623|Secondary|Number of Participants With Red Blood Cell Transfusions|The number of participants who received RBC transfusions were reported.|Up to Week 36|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
1295736|NCT00077623|Secondary|Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration|All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.|Evaluation period (Week 29 to Week 36)|The Intent-to-Treat (ITT) population included all randomized participants.|||participants|||Number
1295737|NCT00077623|Primary|Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods|A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)|The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to stable baseline Hb values, inadequate iron status, hemoglobinopathies/hemolysis, RBC transfusion/blood loss, with <5 recorded Hb values during the evaluation period, with missing administrations of the study drug/ reference drug|||g/dL||Standard Deviation|Mean
1295738|NCT00077610|Secondary|Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.|Upto Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||participants|||Number
1295739|NCT00077610|Secondary|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52|Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline value and a value for specified time period.|Baseline, Week 36 and Week 52|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||beats per minute (bpm)||Standard Deviation|Mean
1295740|NCT00077610|Secondary|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52|Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).|Baseline, Week 36 and Week 52|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1295741|NCT00077610|Secondary|Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes|Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||participants|||Number
1295742|NCT00077610|Secondary|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)|Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L.|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||participants|||Number
1295743|NCT00077610|Secondary|The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods|The number of participants who received RBC transfusions during the titration and evaluation periods were reported .|Week 1 to Week 36|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not.|||participants|||Number
1295744|NCT00077610|Secondary|Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.|The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.|Baseline, Week 29 to Week 36|The intent-to-treat (ITT) population was defined as all randomized participants. At the end of Week 36, data allowing the evaluation of the therapeutic response was available for 196/221, 188/220, and 205/225 participants in RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks), and Epoetin (1 -3x/Weeks), respectively.|||participants|||Number
1295745|NCT00077610|Primary|Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period|A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.|Baseline, Week 29 to Week 36|The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to Hb parameters and <5 recorded Hb values during the evaluation period with missing administrations of the study drug/ reference drug. Please refer to the outcome measure description section for more details.|||gram per deciliter (g/dL)||Standard Deviation|Mean
1295746|NCT00077376|Secondary|Kaplan-Meier Estimate of Overall Survival at 3 Years for All Treated Patients|Survival estimate from the Kaplan-Meier curve of the proportion of patients alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All treated patients|||Percentage of Participants||95% Confidence Interval|Number
1295747|NCT00077376|Secondary|Kaplan-Meier Estimate of Overall Survival at 3 Years for HER2+ Patients|Survival estimate from the Kaplan-Meier curve of the proportion of patients alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years|HER2+ patients|||Percentage of Participants||95% Confidence Interval|Number
1295748|NCT00077376|Secondary|Time to Treatment Failure for All Treated Patients|Time from study entry to the date at which a patient was removed from treatment due to progression, toxicity, refusal or death. If a patient was considered to be a major treatment violation or was taken off study as a non-protocol failure, the patient would be censored on the date he/she was removed from treatment.|Assessed every cycle until treatment discontinuation|All treated patients|||Months||95% Confidence Interval|Median
1295749|NCT00077376|Secondary|Time to Treatment Failure for HER2+ Patients|Time from study entry to the date at which a patient was removed from treatment due to progression, toxicity, refusal or death. If a patient was considered to be a major treatment violation or was taken off study as a non-protocol failure, the patient would be censored on the date he/she was removed from treatment.|Assessed every cycle until treatment discontinuation|HER2+ patients|||Months||95% Confidence Interval|Median
1295750|NCT00077376|Secondary|Time to Disease Progression for All Treated Patients|This interval will be measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression based on RECIST. Patients progression-free at last follow-up were censored.|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|All treated patients|||Months||95% Confidence Interval|Median
1295751|NCT00077376|Secondary|Time to Disease Progression for HER2+ Patients|This interval will be measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression based on RECIST. Patients progression-free at last follow-up were censored.|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|HER2+ patients|||Months||95% Confidence Interval|Median
1295785|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1295882|NCT00075816|Secondary|Relapse|Analysis restricted to patients who received the transplant.|Measured at 2 years||||percentage of patients||95% Confidence Interval|Number
1295752|NCT00077376|Secondary|Objective Response for All Treated Patients (the Best Response a Patient Has Ever Experienced on Study)|"To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.~The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks."|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|All treated patients|||Participants|||Number
1295753|NCT00077376|Primary|Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)|"To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.~The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks."|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|HER2+ patients|||Participants|||Number
1295754|NCT00077207|Secondary|Total Number of Patients Experiencing a Response|Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease.|Up to 18 months of protocol therapy|Sixty-five (65) eligible patients were enrolled and received protocol therapy. Of these patients, 60 had data submission sufficient to determine response.|||Participants|||Count of Participants
1295755|NCT00077207|Secondary|Percentage Probability of Event-free Survival (EFS)|Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.|Six years|Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.|||percent probability EFS||95% Confidence Interval|Number
1295756|NCT00077207|Secondary|Percent Probability of Progression-free Survival (PFS)|Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.|3 years|Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.|||Percent probability PFS||95% Confidence Interval|Number
1295757|NCT00077207|Secondary|Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.|Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy.|Up to 18 months of protocol therapy|Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.|||Participants|||Count of Participants
1295758|NCT00077207|Secondary|Number of Participants Who Experienced Toxic Death|Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin.|Up to 6 years after the start of protocol therapy|Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.|||Participants|||Count of Participants
1295759|NCT00077207|Primary|Long Term Feasibility Success|"Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.~If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success."|60 weeks|Fourteen (14) patients were considered not evaluable for long-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.|||participants|||Number
1295760|NCT00077207|Primary|Short Term Feasibility Success|"Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.~Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure."|24 weeks|Fourteen (14) patients were considered not evaluable for short-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.|||participants|||Number
1295761|NCT00077064|Secondary|Persistence of Pulmonary Toxicity at 2 Years After Completion of Study Treatment|Patients who experienced a Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation were assessed to determine if the toxicity persisted for 2 years.|2 years from completion of study treatment|Randomized patients who received study drug treatment and experienced lung toxicity at 1 year|||Participants|||Count of Participants
1295762|NCT00077064|Secondary|Correlation of Quality of Life With Late Effects as Measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or EORTC Lung Cancer Module (LC-13)|Only 2 patients have the required data- only 1.2% of the planned enrollment and 2.5% of the actual enrollment- which is extremely problematic as this data cannot be generalized, leads to selection bias, and is not representative of the patient population. Therefore the analysis was not conducted.|Baseline to 18 months post treatment|Eligible patients with late effect and baseline and 12-month EORTC data|||Participants|||Count of Participants
1295764|NCT00077064|Primary|Incidence of Therapy-induced Lung Toxicity|Incidence of Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation. Assuming that the incidence of pulmonary toxicity would be 50%, based on Fisher’s exact test with a one-sided significance level of 0.05,168 randomized patients would be required to have 80% statistical power to detect a 40% relative reduction (from 50% to 30%) in the incidence of pulmonary toxicity while receiving captopril. Assuming that 15% of cases would not continue to the randomization stage and 5% of patients would be found ineligible, the target sample size was 205 patients. Given the actual sample size, power would be 25% and therefore p-values were not reported.|Once all patients have been followed for at least 12 months|Randomized eligible patients who started study drug treatment and were followed for one year after completion of radiation treatment or experienced radiation-induced pulmonary toxicity.|||percentage of participants||95% Confidence Interval|Number
1295765|NCT00076999|Primary|Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation|Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.|up to 288 weeks|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.|||participants|||Number
1295766|NCT00076999|Primary|Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation|Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.|up to 288 weeks|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.|||participants|||Number
1295767|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48||week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1295768|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24||week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1295769|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16||week 16|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1295770|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8||week 8|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1295771|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||percentage of cells||Inter-Quartile Range|Median
1295772|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||percentage of cells||Inter-Quartile Range|Median
1295773|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||percentage of cells||Inter-Quartile Range|Median
1295774|NCT00076999|Secondary|Median Baseline CD4 Percent|Percentage of lymphocytes that are CD4 cells|baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||percentage of cells||Inter-Quartile Range|Median
1295775|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||cells/mm3||Inter-Quartile Range|Median
1295776|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||cells/mm3||Inter-Quartile Range|Median
1295777|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||cells/mm3||Inter-Quartile Range|Median
1295778|NCT00076999|Secondary|Baseline Median CD4+ Cell Count (Cells/mm3)||baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||cells/mm3||Inter-Quartile Range|Median
1295779|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||log10 copies/mL||Inter-Quartile Range|Median
1295780|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||log10 copies/mL||Inter-Quartile Range|Median
1295781|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||log10 copies/mL||Inter-Quartile Range|Median
1295782|NCT00076999|Secondary|Baseline Median Viral Load log10 Copies/mL||baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||log10 copies/mL||Inter-Quartile Range|Median
1295783|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
1295792|NCT00003222|Primary|Measure of Tumor-antigen-specific Immunity in Sentinel Immunized Node (SIN) by Elispot Assay||Weeks 0-6,12; Months 6,12 and 24|Analysis of this outcome measure was performed on subjects in Stage I of the trial. Sentinel immunized nodes (SIN) were not evaluable for early tumor progression (5 arm 1, 2 arm 2) and patient refusal (1 arm 2). Thus, SINs were evaluable from 8 in arm 1 and 10 on arm 2, exceeding the protocol requirement for at least 6 subjects on each arm.|||responders|||Number
1295793|NCT00003222|Primary|Measure of Tumor-antigen-specific Immunity in Peripheral Blood Mononuclear Cells (PBMC) by Elispot Assay||Weeks 0-6,12; Months 6,12 and 24|The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm. Some patients were not evaluable because of inadequate sample availability.|||responders|||Number
1295794|NCT00003222|Primary|Evaluation of Objective Clinical Response (CR/PR/SD)|The primary end point for this trial was clinical response. This was assessed by measurement of assessable metastatic deposits by CT, MRI, or direct measure of cutaneous deposits. Baseline tumor measurements used for assessment of clinical response were those obtained most immediately before the first vaccine administration and within 6 weeks of protocol entry. Measurements were made and reviewed by a multidisciplinary team. The original protocol defined tumor response on the basis of changes in cross-sectional area calculated as the product of two perpendicular measures. However, since the initiation of this study, the Response Evaluation Criteria in Solid Tumors Group (RECIST) system was employed as the current standard for clinical trials, in which response is based on changes in maximum cross-sectional dimensions. Computed tomography scans of clinical responders were reviewed again by a senior faculty radiologist not otherwise involved in the study.|Weeks 0-6,12; Months 6,12 and 24|The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm.|||participants|||Number
1295795|NCT00076804|Primary|Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm||24 months||||cells/uL||Inter-Quartile Range|Median
1295796|NCT00076804|Primary|Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm||12 months||||cells/uL||Inter-Quartile Range|Median
1295797|NCT00076804|Primary|Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment|Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)|24 months||||participants|||Number
1295798|NCT00076804|Primary|Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment|Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat|at 12 and 24 months of treatment||||participants|||Number
1295799|NCT00076752|Secondary|Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)|The SLEDAI activity index test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a SLEDAI score of ≤3; partial response is at least 50% improvement in general disease activity as measured by SLEDAI. Remission is a SLEDAI score <3 and prednisone <10mg/day. 6+ indicates active disease requiring therapy. A score of 0 indicates a better outcome and a score greater then 6+ indicates a worse outcome.|Day -7, day 0, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||scores on a scale.||Standard Deviation|Mean
1295800|NCT00076752|Secondary|Natural Killer Cells|The natural killer cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 87-505 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
1295801|NCT00076752|Secondary|Cluster of Differentiation 19 (CD19) + Cells|The CD19 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 47-409 u/L.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
1295802|NCT00076752|Secondary|Cluster of Differentiation 8 (CD8) + Cells|The CD8 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 194-836 u/L.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
1295803|NCT00076752|Secondary|Cluster of Differentiation 4 (CD4) + Cells|The CD4 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 358-1259 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
1295804|NCT00076752|Secondary|Cluster of Differentiation 3 (CD3) + Cells|The CD3+Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 650-2108 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
1295805|NCT00076752|Secondary|Platelet Count|The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||K/uL||Standard Deviation|Mean
1295806|NCT00076752|Secondary|Absolute Lymphocyte Count|The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||K/uL||Standard Deviation|Mean
1295807|NCT00076752|Secondary|Absolute Neutrophil Count|The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||K/uL||Standard Deviation|Mean
1295808|NCT00076752|Secondary|White Blood Cells|The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||K/uL||Standard Deviation|Mean
1295809|NCT00076752|Secondary|Anti-Smith-Ribonuclear Protein Antibody|Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years.||||EU||Standard Deviation|Mean
1295810|NCT00076752|Secondary|Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody|Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||IU||Standard Deviation|Mean
1295811|NCT00076752|Secondary|Extractable Nuclear Antigen (ENA)|Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||EU||Standard Deviation|Mean
1295812|NCT00076752|Secondary|Anti-Nuclear Antibody|Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||EU||Standard Deviation|Mean
1295813|NCT00076752|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|18 months||||participants|||Number
1295814|NCT00076752|Primary|Relapse-free Complete Clinical Response|Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later.|60 months|Ninth participant was taken off study before proceeding with transplant per principal investigator due to decision to put study on hold.|||Months||Full Range|Median
1295815|NCT00076622|Secondary|Cognitive Function (MMSE)|The Mini Mental State Examination (MMSE) measures cognitive function in multiple domains, including memory, orientation, language, and executive function. Scores range from zero (severe cognitive impairment) to thirty (intact cognitive function).|Measured at Month 12||||units on a scale||Standard Deviation|Mean
1295816|NCT00076622|Primary|Number of Falls Experienced by Participants Over Twelve Months of Surveillance||Measured from Baseline through Month Twelve||||number of falls|||Number
1295817|NCT00076622|Primary|Geriatric Depression Scale (GDS) Score|The GDS scale measures presence and severity of depressive symptoms in older adults. Scores range from zero (no depression symptoms) to thirty (severe depression symptoms).|Measured at Month 12||||units on a scale||Standard Deviation|Mean
1295818|NCT00076570|Secondary|The Rate of Significant Drug-associated Complications.||3 years||||participants|||Number
1295819|NCT00076570|Primary|The Rate of Allograft Rejection||3 years||||participants|||Number
1295820|NCT00003298|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.|assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10|eligible and treated patients on step 1|||years||90% Confidence Interval|Median
1295821|NCT00003298|Secondary|Overall Survival|Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.|assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10|eligible and treated patients on step 1|||years||90% Confidence Interval|Median
1295822|NCT00003298|Primary|Grade 3 or Higher Toxicity Incidence on Step 1|Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.|assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)|eligible and treated patients on step 1|||percentage of participants||95% Confidence Interval|Number
1295823|NCT00003298|Secondary|Best Confirmed Response to Neoadjuvant Therapy|Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.|Assessed at surgery time (surgery performed during week 8-10 after registration to the study)|Eligible and treated patients on step 1. Since no patient had a complete response in the study, one-sided 95% confidence interval was provided here.|||percentage of participants||95% Confidence Interval|Number
1295868|NCT00075829|Secondary|Cumulative Incidence of Progression/Relapse|Patients are considered experiencing an event when they progress. Deaths without progression are considered as a competing risk. Patients initiating non-protocol anti-myeloma therapy are considered to have progressed on this protocol.|Year 3|Patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
1295883|NCT00075816|Secondary|Chronic GVHD||Measured at 2 years||||percentage of participants||95% Confidence Interval|Number
1295824|NCT00076336|Secondary|Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score|Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy).|Baseline and Week 104|"The analysis was done on the intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP."|||Participants|||Number
1295825|NCT00076336|Secondary|Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104|Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. “Worsening” of CTP score was defined as a 2-point or greater increase from baseline, “improvement” in CTP score was defined as a 2-point or greater reduction from baseline, and “stabilization” of CTP score was defined as a change of 1-point or less from baseline.|From Baseline to weeks 52 and 104|"The analysis was done per intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP."|||Participants|||Number
1295826|NCT00076336|Secondary|Duration of Initial Clinical Response|Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response – date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date.|Baseline to Week 104|The analysis was on intention-to-treat (ITT) population. Only patients who achieved clinical response were considered.|||Days||Standard Error|Mean
1295827|NCT00076336|Secondary|Time to Initial Clinical Response|Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.|From Baseline to Week 104|The analysis was on intention-to-treat (ITT) population. Only the observed time to initial clinical response was summarized.|||Days||Standard Deviation|Mean
1295828|NCT00076336|Primary|Number of Participants With Clinical Response|Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA < 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.|From Baseline to Week 52|The analysis was on the intention-to-treat (ITT) population.|||Participants|||Number
1295829|NCT00076258|Primary|Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)|The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).|12 weeks||||percentage of participants in remission|||Number
1295830|NCT00076245|Primary|Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD)|Dichotomous Remission Status (remitted or not) at post-treatment|Post-treatment||||participants|||Number
1295831|NCT00076245|Primary|Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version|The Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcome. Range of scores is 0 to 73. Generally, a score of 20 or higher is the cutoff for clinical depression.|Post-treatment||||units on a scale||Standard Deviation|Mean
1295832|NCT00076219|Primary|60-day All-cause Mortality|60-day all-cause mortality|60 days|Number of all-cause mortality by day 60|||participants|||Number
1295833|NCT00076102|Secondary|Number of Participants Who Contributed to the Tissue Bank|Tumor specimens from patients who undergo tumor surgery or biopsies for clinical reasons.|5 years|Participants declined to contribute specimens for the tissue bank.||||||
1295834|NCT00076102|Secondary|Number of Participants With A Response Evaluation Determined by the Comparison of Three-Dimensional (3D) Magnetic Resonance Imaging|Index lesions will be followed for progression by 3D magnetic resonance imaging. Compete response is a complete resolution of all measurable or palpable soft tissue tumors for ≥4 weeks and no appearance of new lesions. Partial response is a ≥50% reduction in the sum of the volume of all index lesions for ≥4 weeks. Progression is defined as a ≥20% increase in the volume of at least one of the index plexiform neurofibromas compared to the pretreatment volume measured prior to the start of treatment. Stable disease is a <20% increase, and <25% decrease in the sum of the volume of all index lesions for ≥4 weeks. Minor response is a ≥25% but <50% reduction in the sum of the volume of all index lesions for ≥4 weeks.|Prior to cycles 1, 4, 7, and 10 and then every 6 cycles thereafter, approximately 5 years|Five patients were not analyzed due to clinical progression (n=1), plexiform neurofibroma surgery (n=1), progression in a pre-existing brain tumor (n=1), and refusal of further therapy (n=2).|||Participants|||Count of Participants
1295835|NCT00076102|Secondary|Number of Participants With A Response Evaluation Determined by the Comparison of Two-Dimensional (2D) Magnetic Resonance Imaging|Index lesions will be followed for progression by 2D magnetic resonance imaging. Progression is defined as a ≥20% increase in the volume of at least one of the index plexiform neurofibromas compared to the pretreatment volume measured prior to the start of treatment.|Prior to cycles 1, 4, 7, and 10 and then every 6 cycles thereafter until progression|This outcome measure was not done because only 3D imaging was performed. Due to a detailed comparison of 1D-2D and 3D imaging for another study (Tipifarnib R115777) the investigator determined that a detailed comparison of 1D-2D and 3D analysis would really add no new knowledge. Therefore only 3D analysis was performed for this trial.||||||
1295836|NCT00076102|Secondary|Number of Participants With A Response Evaluation Determined by the Comparison of One-Dimensional (1D) Magnetic Resonance Imaging|Index lesions will be followed for progression by 1D magnetic resonance imaging. Progression is defined as a ≥20% increase in the volume of at least one of the index plexiform neurofibromas compared to the pretreatment volume measured prior to the start of treatment.|Prior to cycles 1, 4, 7, and 10 and then every 6 cycles thereafter until progression|This outcome measure was not done because only 3D imaging was performed. Due to a detailed comparison of 1D-2D and 3D imaging for another study (Tipifarnib R115777) the investigator determined that a detailed comparison of 1D-2D and 3D analysis would really add no new knowledge. Therefore only 3D analysis was performed for this trial.||||||
1295837|NCT00076102|Secondary|Longitudinal Total Quality of Life Scores Assessed by the Impact of Pediatric Illness Scale|"Quality of life was assessed by the Impact of Pediatric Illness scale for children 6-18 years of age. The child's primary caregiver completed the proxy Parent Form and children answered either the self-report Child or Adolescent (11-18 years) Form prior to cycles 1, 4, 7 and 10. The parallel IPI Scale forms assess four domains: adaptive behavior, emotional functioning, medical/physical status, and cognitive functioning. Responses to the 43 items are made on a 3-or5-point Likert scale (1 to 5 for Parent and Adolescent Form and 1, 3, 5 for the Child Form) ranging from not at all to a lot. Item scores are transformed to a scale of 0-100, and then mean scores are calculated for the four domains and total scale with higher scores indicating better QOL."|prior to cycles 1, 4, 7 and 10.|Of the 36 pts enrolled, 28 were within the age range of the IPI Scale at baseline. 2 pts did not have any QOL forms completed; 1 did not have a baseline & 6 pts had missing f/u evals. QOL data is presented for 19 pts. Due to pts not completing forms at random f/u evals, some time points have fewer than 19 pts included in the longitudinal analysis.|||scores on a scale||Standard Deviation|Mean
1295838|NCT00076102|Secondary|Quality of Life (QOL) Using the Impact of Pediatric Illness (IPI) Scale at Baseline|"Quality of life was assessed by the Impact of Pediatric Illness scale for children 6-18 years of age. The child's primary caregiver completed the proxy Parent Form and children answered either the self-report Child or Adolescent (11-18 years) Form. The parallel IPI Scale forms assess four domains: adaptive behavior, emotional functioning, medical/physical status, and cognitive functioning. Responses to the 43 items are made on a 3-or5-point Likert scale (1 to 5 for Parent and Adolescent Form and 1, 3, 5 for the Child Form) ranging from not at all to a lot. Item scores are transformed to a scale of 0-100, and then mean scores are calculated for the four domains and total scale with higher scores indicating better QOL. Baseline comparisons between child and parent total and domain scores were performed."|Baseline|Of the 36 patients enrolled, 28 were within the age range of the IPI Scale at baseline. Two patients did not have any QOL forms completed; one did not have a baseline evaluation, and six patients had missing follow-up evaluations. Thus, QOL data is presented for 19 subjects.|||Scores on a scale||Standard Deviation|Mean
1295839|NCT00076102|Primary|Percentage of Participants Who Had an Objective Response Rate|Objective response rate is defined as a complete response (CR) or partial response (PR). Complete response is a complete resolution of all measurable or palpable soft tissue tumors for ≥4 weeks and no appearance of new lesions. Partial response is a ≥50% reduction in the sum of the volume of all index lesions for ≥4 weeks.|≥4 weeks||||percentage of participants|||Number
1295840|NCT00076102|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years||||Participants|||Count of Participants
1295841|NCT00076102|Primary|Median Time to Disease Progression|Time to progression is defined as greater than or equal to 20% increase in plexiform neurofibromas (PN) volume on magnetic resonance imaging (MRI).|5 years||||Months||95% Confidence Interval|Median
1295842|NCT00076050|Secondary|Change in Vaginal Maturation Value|The Vaginal Maturation Value (VMV) describes the proportion of the three vaginal epithelial cell types (parabasal, intermediate and superficial) obtained from a swab of the vaginal walls. The changes in the proportion of each type of cells reflects the degree of exposure to estrogen of the vaginal epithelium. The VMV lists the percentage of each type of cell appearing on the smear, with the total of all three values equaling 100%. The index is read from left to right; i.e. VMI of 5/40/55 represents 5% parabasal cells, 40% intermediate cells and 55% superficial cells. Exposure to estrogens results in some parabasal cells, a greater proportion of intermediate cells and few superficial cells.|baseline and 2 years||||score||Standard Error|Mean
1295843|NCT00076050|Secondary|Changes in Women's Health Questionnaire Score|This self-administered questionnaire contains 23 items, distributed among 6 factors: anxiety and depressed mood (7 items), well-being (4 items), somatic symptoms (5 items), memory and concentration (3 items), vasomotor symptoms (2 items) and sleep problems (2 items). The instrument has a structured format and the response choices consist of 4-point Likert scales (‘yes definitely’ to ‘no, not at all’). Item scores are collapsed into a dichotomous scale, where higher scores indicate a greater level of symptomatology or difficulty; i.e., if the response is 1 or 2 (positive response), the score = 1; if the response is 3 or 4 (negative response), the score is 0. Results can be reported as a total score, where the range is 0-23, but also for each dimension. Thus, the ranges of the subscales are: for anxiety and mood 0-7, for well-being 0-4, somatic symptoms 0-5, memory and concentration 0-3, vasomotor symptoms 0-2 and sleep problems 0-2.|baseline and 2 years||||change in score||Standard Error|Mean
1295844|NCT00076050|Primary|Change From Baseline in Bone Mineral Density||baseline and 2 years||||g/cm2||Standard Deviation|Mean
1295845|NCT00076024|Other Pre-specified|Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks|||||||
1295869|NCT00075829|Secondary|Overall Survival (OS) for High Risk|The event is death from any cause, patients alive at the time of last observation are considered censored.|Year 3|Patients that completed second transplant|||percentage of participants||95% Confidence Interval|Number
1295870|NCT00075829|Secondary|Overall Survival (OS) for Standard Risk|The event is death from any cause, patients alive at the time of last observation are considered censored.|Years 1, 2, and 3|Patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
1295846|NCT00076024|Secondary|Duration of Response (DR) for Phase 2 (Open-label)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks|Subgroup of participants from the AT population with a confirmed objective tumor response (CR or PR).|||days||95% Confidence Interval|Median
1295847|NCT00076024|Secondary|Duration of Response (DR) for Phase 2 (Double-blind)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).|||days||95% Confidence Interval|Median
1295848|NCT00076024|Secondary|Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks|All treated (AT) population included participants from Phase 2 who progressed by RECIST criteria while in the placebo + docetaxel treatment group and had a baseline disease assessment and received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1295849|NCT00076024|Secondary|Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks|Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.|||percentage of participants||95% Confidence Interval|Number
1295850|NCT00076024|Primary|Time to Tumor Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks|Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.|||days||95% Confidence Interval|Median
1295851|NCT00076011|Other Pre-specified|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks|||||||
1295852|NCT00076011|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose|Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease. The 'n' is signifying those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
1295853|NCT00076011|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event (AE) data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1295854|NCT00076011|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
1295855|NCT00076011|Secondary|Time to Disease Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.|||Days||95% Confidence Interval|Median
1295856|NCT00076011|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.|||Percentage of participants||95% Confidence Interval|Number
1295857|NCT00075946|Secondary|Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization|The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL.|Assessed at baseline and 6 months after randomization.|Patients with patient-reported outcomes (PRO) data available.|||units on a scale||Standard Deviation|Mean
1295858|NCT00075946|Secondary|Time to First Cytotoxic Therapy (TTFC)|TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years.|Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first.|Patients who were correctly randomized to one of the two maintenance arms.|||probability||95% Confidence Interval|Number
1295859|NCT00075946|Primary|Time to Rituximab Failure (TTRF)|TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression < 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).|Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.|Eligible patients who were randomized to one of the two arms for maintenance therapy.|||years||95% Confidence Interval|Median
1295860|NCT00075881|Secondary|1-year Progression Free Survival Probability|Progression-free survival is defined as time from randomization to disease progression or death from any cause, whichever occurred first. Disease progression is defined using the ECOG Myeloma Response Criteria. Kaplan-Meier method is used to estimate the 1-year progression-free survival probability. 42 eligible and treated patients were included in the analysis.|Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry|42 eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
1295861|NCT00075881|Secondary|Response Rate on Reinduction|ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 7 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days|7 eligible and treated patients were included in the analysis.|||percentage of participants||90% Confidence Interval|Number
1295862|NCT00075881|Secondary|Response Rate on Maintenance|ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 15 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days|15 eligible and treated patients were included in the analysis.|||percentage of participants||90% Confidence Interval|Number
1295863|NCT00075881|Primary|Response Rate on Induction|Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days|42 eligible and treated patients were included in the analysis.|||percentage of participants||90% Confidence Interval|Number
1295864|NCT00075829|Secondary|Incidences of Chronic GVHD|Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.|Years 1 and 2|GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
1295865|NCT00075829|Secondary|Incidences of Graft Versus Host Disease (GVHD)|Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.|Day 100|GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
1295884|NCT00075816|Secondary|Extensive Chronic Graft-versus-host Disease (GVHD)||Measured at 730 days||||percentage of patients||95% Confidence Interval|Number
1295889|NCT00075803|Secondary|Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days||1 year||||participants|||Number
1295890|NCT00075803|Secondary|Failure to Engraft||day 42||||participants|||Number
1295891|NCT00075803|Secondary|Time to Platelet Engraftment||180 days|||||||
1295892|NCT00075803|Secondary|Time to Neutrophil Engraftment||28 days|||||||
1295893|NCT00075803|Secondary|Utility of Galactomannan Assay in Diagnosis of Aspergillus and Response to Therapy|Although there were 82 Galactomannan (GM) positives, 4 were excluded due to piperacillin/tazobactam administration, without other documentation of IFI, and were deemed false positives.|1 year||||participants|||Number
1295894|NCT00075803|Secondary|Time to and Severity of Acute and Chronic Graft vs Host Disease (GVHD)||100 and 365 days||||participants|||Number
1295895|NCT00075803|Secondary|Duration of Use of Amphotericin B or Caspofungin||180 days||||days||Inter-Quartile Range|Mean
1295896|NCT00075803|Secondary|Frequency of Use of Amphotericin B or Caspofungin||1 year||||percentage of patients||95% Confidence Interval|Number
1295897|NCT00075803|Secondary|Relapse Free Survival||100, 180, and 365 days||||percentage of patients||95% Confidence Interval|Number
1295898|NCT00075803|Secondary|Overall Survival||100, 180, and 365 days||||percentage of patients||95% Confidence Interval|Number
1295899|NCT00075803|Secondary|Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days||100, 180, and 365 days||||percentage of patients||95% Confidence Interval|Number
1295900|NCT00075803|Secondary|Frequency of Invasive Fungal Infections (IFI)|Incidence of proven, probably, or presumptive IFI|1 year||||percentage of patients||95% Confidence Interval|Number
1295901|NCT00075803|Primary|Fungal-free Survival (Percentage of Participants Alive and Free From Proven, Probable, or Presumptive Invasive Fungal Infection) at 180 Days Post-transplant||180 days|All randomized patients were included in the analysis|||percentage of patients||95% Confidence Interval|Number
1295902|NCT00075764|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE version 3.0 terminology. For each patient, worst grade of each event type is reported. Grade3 (Severe), Grade4 (Life-threatening), Grade 5 (Fatal)|Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1295903|NCT00075764|Secondary|Overall Survival|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.||||months||95% Confidence Interval|Median
1295904|NCT00075764|Secondary|Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable, Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Clinical Benefit = CR + PR + Stable >= 24 weeks|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.||||percentage of participants|||Number
1295905|NCT00075764|Primary|Time to Tumor Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.||||months||95% Confidence Interval|Median
1295906|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).|Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.|5 years|Group “Prednisone and High Dose MTX (non-random)” who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.|||percentage of participants||95% Confidence Interval|Number
1295907|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)|Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.|5 years|"Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) & Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up."|||percentage of participants||95% Confidence Interval|Number
1295908|NCT00075725|Secondary|Correlation of Early Marrow Response Status With MRD Negative.|Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|Day 29||||participants|||Number
1295909|NCT00075725|Secondary|Correlation of Early Marrow Response Status With MRD Positive.|Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|Day 29||||participants|||Number
1295937|NCT00075400|Secondary|Initial Histologic Grade|G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
1295910|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).|Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.|5 years|"Patients on Arm/Group Prednisone and High Dose Methotrexate (non randomly assigned) are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up."|||percentage of participants||95% Confidence Interval|Number
1295911|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)|Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|5 Years|"Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) & Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up."|||percentage of participants||95% Confidence Interval|Number
1295912|NCT00075725|Primary|Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions|Event Free Probability.|5 years|Group “Prednisone and High Dose MTX (non-random)” who either had EFS events occur before 5 years or did not have minimum 5 years of follow-up.|||percentage of participants||95% Confidence Interval|Number
1295913|NCT00075608|Primary|Evaluate Immune Reconstitution|Evaluate immune reconstitution based on time to engraftment|3 months after treatment and annually|No data were collected or analyzed due to study termination||||||
1295914|NCT00075608|Primary|Response and Durability of Response|Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death|3 months after treatment and annually|No data were collected or analyzed due to study termination||||||
1295915|NCT00075608|Primary|Feasibility and Tolerability|Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events|3 months after treatment and annually|No data were collected or analyzed due to study termination||||||
1295916|NCT00075582|Secondary|Rate of Local Failure for Patients With Clinical Group III Disease When the Radiotherapy Dose is Reduced After Second-look Surgical Resection.|The local failure rate will be estimated using cumulative incidence curves.|Up to 20 weeks|||||||
1295917|NCT00075582|Secondary|Rate of Second-look Surgery and the Proportion of Patients Who Are Tumor-free or With Microscopic Tumor Only Following Second-look Surgeries|The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.|At 13 weeks|||||||
1295918|NCT00075582|Secondary|Rate of Local Failure for Patients Who Receive Reduced Doses of Radiation Therapy|The local failure rate will be estimated using cumulative incidence curves.|Up to 10 years|||||||
1295919|NCT00075582|Primary|Estimated Percentage of Patients With Low-risk Rhabdomyosarcoma Treated With Regimen 2 Therapy Failure Free at 5 Years (95% Confidence Interval).|Failure free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.|||Estimated percentage of participants||95% Confidence Interval|Number
1295920|NCT00075582|Primary|Estimated Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Group I or Stage 2 Group II Disease Treated With Regimen 1 Failure-free at 5 Years|Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.|||Estimated percentage of participants||95% Confidence Interval|Number
1295921|NCT00075582|Primary|Estimated Percentage of Patients Failure Free at 5 Years (95% Confidence Interval)|Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.|||Estimated percentage of participants||95% Confidence Interval|Number
1295922|NCT00075504|Secondary|Overall Survival||Up to 2 years||||months||95% Confidence Interval|Median
1295923|NCT00075504|Secondary|Progression Free Survival|PFS will be measured from the time of the patient’s initial best response (PR or CR) until documented progression.|Up to 2 years||||months||95% Confidence Interval|Median
1295924|NCT00075504|Primary|Response Rate According to RECIST Criteria|Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR.|Up to 2 years||||participants|||Number
1295925|NCT00075478|Secondary|Progression-free Survival|Percentage of patients with progression-free survival, estimated by cumulative incidence methods|3 years after transplant||||percentage of participants|||Number
1295926|NCT00075478|Secondary|Incidence of Graft Rejection|Donor CD3 chimerism less than 5%|1 year after transplant||||participants|||Number
1295927|NCT00075478|Secondary|Incidence of Chronic Extensive GVHD|Percentage patients with chronic extensive GVHD, estimated by cumulative incidence methods|3 years after transplant||||percentage of participants|||Number
1295928|NCT00075478|Secondary|Incidence of Grades II-IV Acute GVHD|Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods|120 days after transplant||||percentage of participants|||Number
1295929|NCT00075478|Secondary|Incidence of Relapse-related Mortality|Percentage of death following relapse/progression, estimated by cumulative incidence methods|3 years after transplant||||percentage of participants|||Number
1295938|NCT00075400|Secondary|Initial Performance Status|Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
1295939|NCT00075400|Secondary|Duration of Progression Free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years|Eligible and treated patients.|||months||Inter-Quartile Range|Median
1295940|NCT00075400|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact|From study entry to death or last contact, up to 5 years.|Eligible and treated patients|||months||95% Confidence Interval|Median
1295941|NCT00075400|Secondary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1295942|NCT00075400|Primary|Incidence of Adverse Effects as Assessed by CTCAE v 3.0|The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.|Each cycle during treatment and 30 days after treatment ends.|Eligible and treated patients|||Participants|||Count of Participants
1295943|NCT00075400|Primary|Progression-free Survival (PFS) > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1295944|NCT00075335|Primary|Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following Plerixafor Administration|Examine plerixafor mobilization effect on cytokine polarization of T-cells. Analyze cytokine gene expression profiles using a Th1-Th2-Th3 RT-PCR plate in CD3+ T cells collected form subjects mobilized with a single injection of plerixafor. 84 cytokine genes were analyzed for significant alteration in their profiles.|1 Day|Subjects who received plexirxafor 240mcg/kg. Data was collected 6 hours after injection.|||unique cytokine genes affected|||Number
1295945|NCT00075335|Primary|Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following G-CSF Administration|Examine G-CSF mobilization effect on cytokine polarization of T-cells. Analyze cytokine gene expression profiles using a Th1-Th2-Th3 RT-PCR plate in CD3+ T cells collected form subjects mobilized with 5 injections of G-CSF. 84 cytokine genes were analyzed for significant alteration in their profiles.|1 Day|8 Subjects received G-CSF for 5 days.|||unique cytokine genes affected|||Number
1295946|NCT00075270|Secondary|Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4|The severity of adverse events was graded per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3. Grades 1 through 5 have unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1, Mild AE; Grade 2, Moderate AE; Grade 3, Severe AE; Grade 4, Life-threatening or disabling AE; Grade 5, death related to AE.|Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks)|Safety Population: all randomized participants who received at least one dose of investigational product (based on the actual treatment received if this differed from that to which the participant was randomized). Two participants randomized to the placebo group actually received lapatinib.|||participants|||Number
1295947|NCT00075270|Secondary|Serum ErbB2 Concentration|The Quest Laboratory collected blood samples for quantitative determination of serum ErbB2. The results of serum monitoring were used to compare tumor response rates following randomized therapy.|Screening (Day-1) and Withdrawal (up to Study Week 129)|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||ng/mL||Standard Deviation|Mean
1295948|NCT00075270|Secondary|Serum ErbB1 Concentration|The Quest Laboratory collected blood samples for quantitative determination of serum ErbB1. The results of serum monitoring were used to compare tumor response rates following randomized therapy.|Screening (Day-1) and Withdrawal (up to Study Week 129)|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1295981|NCT00075088|Primary|Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)|Mean door-to-balloon time|Day 1|42 patients with STEMI who received primary percutaneous coronary intervention|||minutes||Standard Deviation|Mean
1297001|NCT00055692|Primary|To Collect Information on Hepatic Function and Hepatitis Viral Activity in Cirrhosis and Upon Potential Alterations in the Setting of VEGF-inhibition||During and after treatment|No data was collected by the principal investigator for this outcome||||||
1295949|NCT00075270|Secondary|Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results|"The Press Laboratory tested participants who were 2+ (weak to moderate complete staining) or 3+ (strong complete staining) for ErbB2 overexpression by IHC for ErbB2 gene amplification using the FISH assay. The results of the FISH assay can be ErbB2 gene amplification (increased number of copies of the ErbB2 gene) or non-amplification (not many copies of the ErbB2 gene). A status of Assay not done was assigned to those participants with no available samples and to those with inconclusive results (e.g., due to hybridization or staining problems)."|Baseline|ITT Population|||participants|||Number
1295950|NCT00075270|Secondary|Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening|"The Press Laboratory tested tumor tissue samples (taken at Screening, prior to randomization to study treatment) to determine intra-tumoral expression levels of ErbB1, ErbB2, and other analytes associated with these pathways by IHC, the process of detecting antigens (e.g., proteins) in cells of a tissue section. The IHC assessment is expressed as: 0, no staining (no cancer cells); 1+, faint staining; 2+, weak to moderate complete staining; 3+, strong complete staining (many cancer cells). A status of Assay not done was assigned to participants with no available samples and to those with inconclusive results. If strong staining is observed, breast cancer that has high levels of HER2 expression (overexpression) is indicated. If moderate/weak staining is observed (IHC=2+), breast cancer that has low/moderate expression levels is indicated. When no staining is observed (IHC=0), breast cancer HER2 expression may be below the level of detection of the assay."|Screening (Day -1)|ITT Population|||participants|||Number
1295951|NCT00075270|Secondary|ErbB2 Ratio|The Press Laboratory collected tumor tissues of participants for biomarker testing. All samples were analyzed by the Press Laboratory. The ratio of ErbB2 gene signals to chromosome 17 signals, which indicates the progression of breast cancer, was calculated. Low levels of amplification (few copies) may have a ratio of 2-5, whereas high levels of amplification may have a ratio >10.|Baseline|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||ratio of signals||Standard Deviation|Mean
1295952|NCT00075270|Secondary|Number of Participants With the Indicated ErbB2 Status at Baseline|The Press Laboratory collected tumor tissues of participants for ErbB2 testing. ErbB2 testing is done to detect breast cancer and predict its likely outcome. All samples were analyzed by the Press Laboratory. Participants were categorized as ErbB2 positive (overexpression of the ErbB2 gene), ErbB2 negative, and assay not done (which included participants with no available samples and those with inconclusive results). ErbB2 status is determined by immunohistochemistry (ICH) assay and fluorescence in situ hybridization (FISH) testing. Negative ErbB2 status is defined as 0 or 1+ by IHC, or as 2+ by IHC and FISH.|Baseline|ITT Population|||participants|||Number
1295953|NCT00075270|Secondary|Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores|The TOI questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, functional well-being, and additional cancer concerns. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each question scored from 0 [not at all] to 4 [very much]); the breast cancer unweighted subscale scores range from 0 to 36, based on 9 questions. The total TOI score (ranging from 0 [better QOL] to 92 [worse QOL]) is the sum of the TOI subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||Scores on a scale||Standard Deviation|Mean
1295954|NCT00075270|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|The FACT-G questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, social/family, emotional, and functional well-being. The physical, social/family, and functional well-being subscale scores range from 0 to 28, based on responses to 7 questions (each question scored from 0 [not at all] to 4 [very much]); the emotional well-being subscale score ranges from 0 to 24, based on responses to 6 questions. The FACT-G Total Score (ranging from 0 [better QOL] to 108 [worse QOL]) is the sum of the subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||Scores on a scale||Standard Deviation|Mean
1295955|NCT00075270|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores|The FACT-B questionnaire was designed to measure multidimensional quality of life (QOL) in participants with breast cancer. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each scored from 0 [not at all] to 4 [very much] for all subscales); the emotional and social/family well-being (1 question optional) subscale scores range from 0 to 24 (based on 6 questions), and the additional concerns subscale score ranges from 0 to 40, based on 10 questions. The FACT-B Total Score (0 [better QOL] to 144 [worse QOL]) is the sum of the subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.|||Scores on a scale||Standard Deviation|Mean
1295956|NCT00075270|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|Randomization until the date of death due to any cause (average of 24 months)|ITT population. Overall survival was assessed in participants who died as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those still alive), the date of the last contact was used.|||months||95% Confidence Interval|Median
1295979|NCT00075218|Primary|Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase|Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).|Day 28 of each 6-week cycle : duration of double-blind treatment phase|From the Intent to Treat (ITT) population, 82 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 67 subjects on placebo were observed to have disease progression during blinded phase.|||weeks||95% Confidence Interval|Median
1295957|NCT00075270|Secondary|Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause, if sooner. Six months PFS is defined as PFS at six months from the time of randomization. Raw data for 6 months PFS are not available; thus, data are presented as the number of participants who progressed or died at or prior to 6 months. For TLs, progressive disease is defined asat least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. PFS was assessed in participants who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||participants|||Number
1295958|NCT00075270|Secondary|Progression-Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progression disease (PD) or death due to any cause, if sooner. For TLs, progressive disease is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. par., participants.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population. PFS was assessed in par. who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored par. (those without a documented date of disease progression/death due to any cause), the date of the last radiographic assessment was used.|||weeks||95% Confidence Interval|Median
1295959|NCT00075270|Secondary|Duration of Response (DOR)|The investigator evaluated the DOR for the subset of participants who showed a CR (disappearance of all TLs and NTLs) or PR (TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion). DOR is defined as the time from the first documented evidence of PR or CR until the first documented sign of PD (TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion; NTL: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs) or death due to breast cancer, if sooner.|From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)|ITT Population. Only participants who had a CR or PR were evaluated.|||weeks||Inter-Quartile Range|Median
1295960|NCT00075270|Secondary|Number of Participants With a Response of CR or PR by the Indicated Study Week|Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR (disappearance of all TLs and NTLs) or PR (for TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; for NTLs: the persistence of >=1 lesion) (whichever status was recorded first). TTR data are displayed as the number of participants achieving a CR or PR by the indicated week. The investigator evaluated the TTR, and the analysis was based on responses confirmed at a repeat assessment, with the TTR taken as the first time the response was observed.|Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72|ITT Population|||participants|||Number
1295961|NCT00075270|Secondary|Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator|Percentage of participants. with CB is defined as the percentage of participants with evidence of CR (disappearance of all TLs and NTLs), PR (TLs: a >=30% decrease in the sum of the LD, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion), or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) for >=6 months based on RECIST criteria. PD for TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion. PD for NTLs: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||Percentage of participants|||Number
1295962|NCT00075270|Secondary|Number of Participants With Tumor Response as Evaluated by the Independent Review Committee|The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The RECIST criteria was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||participants|||Number
1295963|NCT00075270|Secondary|Number of Participants With Tumor Response as Evaluated by the Investigator|The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The Response Evaluation Criteria in Solid Tumors (RECIST) was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||participants|||Number
1295964|NCT00075270|Primary|Time to Progression as Evaluated by the Independent Review Committee (IRC)|Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||weeks||Inter-Quartile Range|Median
1295965|NCT00075270|Primary|Time to Progression as Evaluated by the Investigator|Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|Intent-to-Treat (ITT) Population: all randomized participants who had received at least one dose of randomized therapy (lapatinib or placebo)|||weeks||Inter-Quartile Range|Median
1295966|NCT00075218|Secondary|Change From Baseline in EQ-5D Health State Profile Index|Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|ITT Population. Number subjects with evaluable data: (n=sunitinib, placebo)|||score on scale||Full Range|Median
1295967|NCT00075218|Secondary|Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)|Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|ITT population. Number subjects with evaluable data: (n=sunitinib, placebo)|||score on scale||Full Range|Median
1295968|NCT00075218|Secondary|Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)|MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by >= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use >= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use >= 50% over baseline.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|Pain-Relief-Response population.|||participants|||Number
1295969|NCT00075218|Secondary|Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)|25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use >= 50% over baseline OR b) Increase score >= 1 point with either NC in total analgesic use or increase total analgesic use >= 50% over baseline. (50th Quartile not achieved.)|Day 1 & 28 of each cycle : duration of double-blind treatment phase|Pain-Relief-Response population. Subjects at 25th Quartile with pain progress during blinded phase.|||weeks (25th Quartile)||95% Confidence Interval|Median
1295970|NCT00075218|Primary|Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study|Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).|Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)|From the Intent to Treat (ITT) population, 91 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 73 subjects on placebo were observed to have disease progression during blinded phase.|||weeks||95% Confidence Interval|Median
1295971|NCT00075218|Secondary|Duration of Performance Status Maintenance|Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.|Day 28 of each cycle : duration of double-blind treatment phase|ITT Population. Number of subjects at median observed to have status worsening or died before status worsening.|||weeks||95% Confidence Interval|Median
1295972|NCT00075218|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.|Day 28 of each cycle : duration of double-blind treatment phase|ITT population. Number of subjects analyzed = number of subjects with tumor response.|||weeks||95% Confidence Interval|Median
1295973|NCT00075218|Secondary|Confirmed Objective Response (CR or PR) in Subjects|Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.|Day 28 of each cycle : duration of double-blind treatment phase|ITT population.|||participants|||Number
1295974|NCT00075218|Secondary|Best Overall Tumor Response During Double-blind Treatment Phase|Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of each cycle : duration of double-blind treatment phase|ITT population|||participants|||Number
1295975|NCT00075218|Secondary|Overall Survival Based on the Rank Preserving Structural Failure Time Method|time from date of randomization to date of death due to any cause (rank preserving structural failure time method).|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population|||weeks||95% Confidence Interval|Median
1295976|NCT00075218|Secondary|Overall Survival|Time from date of randomization to date of death due to any cause.|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population; Number subjects Dead = 176, 90 (sunitinib, placebo respectively). Subjects who were not known to be dead at the time the database was closed for analysis were censored on the date they were last known to be alive.|||weeks||95% Confidence Interval|Median
1295977|NCT00075218|Secondary|Overall Survival Status of Subjects|Number of subjects alive at end of study.|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population.|||participants|||Number
1295978|NCT00075218|Secondary|Progression Free Survival (PFS)|Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).|Day 28 of each cycle : duration of double-blind treatment phase|ITT population|||weeks||95% Confidence Interval|Median
1295982|NCT00075088|Primary|Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI|Time from ED arrival to first drug was determined as recommended by American College of Cardiology/American Heart Association 2007 guidelines for management of patients with unstable angina/non-STEMI|Day 1|Patients with unstable angina/non-STEMI. Four patients with Do Not Resuscitate (DNR) orders were excluded from this time-to-treatment analysis|||minutes||Standard Deviation|Mean
1295983|NCT00075023|Primary|Mean Percentage Change in Total Surface Area of Oral Ulceration.|Mean percentage change in total surface area of oral ulceration|baseline to 4 weeks||||percentage change||Standard Deviation|Mean
1295984|NCT00074984|Secondary|Neuropathic Pain as Assessed by Question 12 of the Brief Pain Inventory (BPI) Questionnaire (Pain at Its Worst)|Neuropathic pain was assessed by Question 12 of the Brief Pain Inventory (BPI) Questionnaire on a scale of 0 (no pain) to 10 (pain as bad as you can imagine)|at 24 months|Intent-to-treat population|||units on a scale||Standard Deviation|Mean
1295985|NCT00074984|Secondary|Slope of Inverse Serum Creatinine Values Comparing Placebo vs Fabrazyme (Agalsidase Beta)Patients|Summary of slopes of inverse serum creatinine by baseline serum creatinine subgroups (> or <= 1.5 mg/dL) comparing Placebo vs Fabrazyme (agalsidase beta) patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.|||dL/mg/year||Standard Deviation|Mean
1295986|NCT00074984|Secondary|Slope of Estimated Glomerular Filtration Rate (eGFR) Comparing Placebo vs Fabrazyme (Agalsidase Beta) Patients|Summary of slopes of eGFR by baseline eGFR subgroups (>60 and <=60 mL/min/1.73m^2/year) comparing Placebo vs Fabrazyme (agalsidase beta) Patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication|||mL/min/1.73m^2/year||Standard Deviation|Mean
1295987|NCT00074984|Secondary|Number of Participants Experiencing a Renal Event in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients|Time to a clinically significant renal event (33% increase in serum creatinine, dialysis or transplant) in Fabrazyme (agalsidase beta) patients as compared to placebo patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.|||participants|||Number
1295988|NCT00074984|Primary|Number of Participants Experiencing a Clinically Significant Renal, Cardiac or Cerebrovascular Event and/or Death in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients|The primary efficacy endpoint was the time to the first occurrence of a clinically significant renal (33% increase in serum creatinine, dialysis or transplant), cardiac (myocardial infarction, significant change in cardiac status, i.e., angina, congestive heart failure or symptomatic arrhythmia requiring medication or surgery) or cerebrovascular (stroke or transient ischemic attack) event and/or death (due to any cause) in Fabrazyme (agalsidase beta) patients as compared to placebo patients.|up to 35 months|The Intent-to-treat (ITT) population consists of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.|||participants|||Number
1295989|NCT00074958|Secondary|Plasma GL-3|Plasma GL-3 values at Baseline, Week 24, and Week 48. Normal plasma GL-3 level is ≤ 7.03 µg/mL.|Baseline, Week 24 and Week 48|ITT population. 16 male patients had plasma GL-3 values at Baseline and Week 24, while 15 male patients had plasma GL-3 values at Week 48. 2 female patients had plasma GL-3 values at Baseline, Week 24 and Week 48.|||µg/mL||Standard Deviation|Mean
1295990|NCT00074958|Primary|Globotriaosylceramide (GL-3) Clearance in Capillary Endothelium in the Skin|Skin biopsies were taken at Baseline, Week 24 and Week 48 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Baseline, Week 24 and Week 48|Intent to Treat (ITT) population – male patients only. 14 patients had skin biopsies performed at Baseline and Week 24 but only 5 patients had skin biopsies performed at Week 48.|||patients|||Number
1295991|NCT00074815|Secondary|Pediatric Adverse Event Rating Scale (PAERS)||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up|||||||
1295992|NCT00074815|Secondary|Child Depression Inventory||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up|||||||
1295993|NCT00074815|Secondary|Child Obsessive -Compulsive Impact Scale (COIS)||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up|||||||
1295994|NCT00074815|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|"OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 – 20), and a composite symptom severity score (0 to 40).~Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure."|Measured at baseline and Week 12.|Intent to treat (all included)|||Proportion of Participants with RESPONSE||95% Confidence Interval|Number
1295995|NCT00074802|Secondary|Quality of Life Inventory (QOLI)|The QOLI is a 16-item self-report measure of life satisfaction. Each item is rated for importance (0-2) and satisfaction (-3 to +3), and these ratings are multiplied, summed, and divided by the number of non-zero entries to yield an average item score, which can range from -6 to +6. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
1296009|NCT00074581|Primary|Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms|incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.|Throughout study||||event rate per 100 person-yr|Person Years|95% Confidence Interval|Number
1295996|NCT00074802|Secondary|Liebowitz Self-Report Disability Scale (LSRDS)|The LSRDS is an 11-item self-report measure of the degree to which one's emotional problems limit one's ability to function in a variety of domains. Items are rated on a 0-3 scale of severity, and 10 of the 11 items (choosing either school or work as one area and omitting the other) are summed to produce a total score, ranging from 0-30. Higher scores represent greater disability. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
1295997|NCT00074802|Secondary|Brief Fear of Negative Evaluation Scale (BFNE)|The BFNE is a 12-item self-report measure of concern about negative evaluation by others. Items are rated on a 1-5 scale, yielding scores ranging from 12-60, with higher scores indicating greater fear of negative evaluation. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
1295998|NCT00074802|Secondary|Social Phobia Scale (SPS)|The SPS is a 20-item self-report measure of anxiety experienced when being observed by others. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
1295999|NCT00074802|Secondary|Social Interaction Anxiety Scale (SIAS)|The SIAS is a 20-item self-report measure of anxiety experienced while interacting in dyads or groups. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
1296000|NCT00074802|Secondary|Clinical Global Impression Improvement Scale (CGI-I)|The CGI-I is a 7-point clinician-administered scale measuring improvement in symptoms over time. Lower numbers represent greater improvement. We examined responder status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1 or 2) as well as remission status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1) as secondary outcomes.|Responder and remitter status measured at Week 28|Responders (CGI-I=1 or 2). Remitters (CGI-I=1). Analyses based on Week 28 observations if available. if not, Week 20 or Week 12 observations were substituted. Fisher's Exact Test used for analyses.|||Participants|||Count of Participants
1296001|NCT00074802|Primary|Liebowitz Social Anxiety Scale (LSAS)|The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
1296002|NCT00074711|Secondary|Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months||Measured at baseline and 12 months||||micromol/mmol||Standard Error|Mean
1296003|NCT00074711|Secondary|Change From Baseline in Urinary N-telopeptide at 12 Months||Measured at baseline and 12 months||||nmol bce/mmol||Standard Error|Mean
1296004|NCT00074711|Secondary|Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months||Measured at baseline and 12 months||||g/g||Standard Error|Mean
1296005|NCT00074711|Secondary|Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months||Measured at baseline and 12 months||||mg/dl||Standard Error|Mean
1296006|NCT00074711|Primary|Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).|The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).|12 months|Participants that completed study.|||g/cm2||Standard Error|Mean
1296007|NCT00074711|Primary|Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.|Bone mineral density (BMD, measured by dual X-ray absorptiometry – DEXA) measured at several intervals during the study. BMD measured as grams per square centimeter (g/cm2).|Measured at Baseline|Postmenopausal women with spinal osteoporosis.|||g/cm2||Standard Deviation|Mean
1296008|NCT00074581|Primary|All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms|All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.|Throughout study|Population includes all partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases, by arm.|||event rate per 100 person-yr||95% Confidence Interval|Number
1297002|NCT00055692|Primary|Assessment on Circulating Levels of VEGF Which Also Contribute to HCC Pathogenesis and on Potential Alterations of These Levels in the Setting of VEGF-inhibition||During treatment|Six of eight patients were analyzed after 8 weeks of bevacizumab therapy|||pg/mL||Standard Deviation|Mean
1296010|NCT00074490|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 5 years||||Participants|||Count of Participants
1296011|NCT00074490|Secondary|Percentage of Patients With Opportunistic Infection|Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease.|First 100 days post-transplant||||percentage of participants|||Number
1296012|NCT00074490|Secondary|Detection of of Post-transplantation Cluster of Differentiation 4 (CD4)+ and CD8+ T-cell Production of T Helper 1 -2 (Th1-Th2)-Type Cytokines|Detection of cytokine secretion was done by enzyme-linked immunosorbent assay.|First 100 days post-transplant|This outcome measure was not done. Data was not collected for this outcome measure due to premature closure of study.||||||
1296013|NCT00074490|Primary|Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)|GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1.|first 100 days post-transplant||||percentage of patients|||Number
1296014|NCT00074490|Primary|Percentage of Patients to Receive T Cell Infusion|T cells administered by intravenous infusion after patient received transplant.|first 100 days post-transplant||||percentage of patients|||Number
1296015|NCT00074412|Secondary|NVP Concentrations in Infants Determined to be HIV-infected and in a Sample of HIV-uninfected Infants|Samples for NVP concentration were selected from the Version 3.0 infants who were randomized to NVP at 6 weeks and whose mothers were not on 3 or more antiretrovirals at the time of randomization. All infants HIV-infected by 6 months who met this criteria were selected and matched to HIV-uninfected infants who also met this criteria in a 1:3 ratio. NVP concentrations were measured by high liquid chromatographic/mass spectroscopy from the aforementioned infants plasma samples collected at week 8 and month 3. Median NVP concentrations were compared|Week 8 and Month 3|||||||
1296016|NCT00074412|Secondary|Rates of Disease Progression as Defined by CD4 Counts, HIV-1 RNA PCR, and Mortality in Infected Infants in the Two Arms||Throughout study|||||||
1296017|NCT00074412|Secondary|Frequency and Duration of NVP-resistant HIV Strains in Plasma of HIV-infected Infants||Throughout study|||||||
1296018|NCT00074412|Secondary|Relationship Between Maternal Plasma and Breast Milk RNA Levels and the Risk of MTCT||Throughout study|||||||
1296019|NCT00074412|Secondary|Frequency and Duration of Maternal Plasma and Breast Milk NVP-resistant HIV Strains and the Relationship With HIV Transmission||Throughout study|||||||
1296020|NCT00074412|Secondary|Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms||At Month 18||||participants|||Number
1296021|NCT00074412|Secondary|Relative Rates of HIV Infection in the Two Arms||At Month 18|A total of 1527 infants were randomized to either placebo or extended NVP. 5 of these infants were later found to be infected at the time of randomization (2 in NVP and 3 in Placebo). Thus, only 1522 infants were included in the analysis.|||participants|||Number
1296022|NCT00074412|Secondary|Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms||At Months 6 and 18|There were 1522 infants randomized at 6 weeks of birth to either the extended Nevirapine arm (759) or the placebo arm (763).|||participants|||Number
1296023|NCT00074412|Primary|Frequency and Severity of Adverse Reactions Among Participating Infants|For those infants who were randomized at 6 weeks and who initiated study drug we looked at the frequency and severity of adverse reactions through 18 months of study. The severity of all AEs was graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The term severity is described as the intensity grade or level for specific event (i.e. mild, moderate, severe, or life-threatening). Severity is not the same as seriousness.|6 weeks through 18 months|A total of 1519 infants, 758 in the NVP arm and 761 in the placebo arm, initiated study product and were thus included in the analysis for the frequency and severity of adverse reactions.|||Number of Adverse Events|Participants||Number
1296024|NCT00074412|Primary|HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study||At Month 6|All infants who were randomly allocated to either treatment or placebo at 6 weeks of age under version 3.0 of the protocol were included in the analysis of the primary endpoint, HIV infection at 6 months. 127/1700 infants were enrolled but excluded from randomization at 6 weeks for various reasons as mentioned in the flow-through.|||participants|||Number
1296025|NCT00074308|Secondary|Overall Survival (Phase II)|Kaplan-Meier estimates of overall survival and 95% confidence intervals will be calculated.|Up to 6 years|Data not collected||||||
1296026|NCT00074308|Secondary|Response Rate at 8 Weeks, Evaluated Using RECIST (Phase II)|"Response and progression was evaluated in this study using Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|8 weeks||||Participants|||Count of Participants
1296027|NCT00074308|Primary|Progression-free Survival at 16 Weeks (Phase II)|Progression Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|16 weeks||||Participants|||Count of Participants
1296028|NCT00074308|Primary|MTD, Defined as One Dose Level Below the Dose That Induced DLT in at Least One Third of Patients at a Dose Level, Graded According to NCI CTCAE Version 3.0 (Phase I)||Up to 28 days||||dose level|||Number
1296029|NCT00074269|Secondary|Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting||1 month post allografting|study was closed early due to lack of accrual.|||Participants|||Count of Participants
1296030|NCT00074269|Secondary|Response (Partial and Complete) as Measured at 12 Months Post Allografting|response assessed by CT scan|From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months|study was closed early due to lack of accrual.|||Participants|||Count of Participants
1296031|NCT00074269|Secondary|Overall Survival||1 year from the time of transplant|study was closed early due to lack of accrual.|||days||Full Range|Median
1296032|NCT00074269|Secondary|Progression-free Survival|Progression assessed by CT scan|From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months|study was closed early due to lack of accrual.|||days||Full Range|Median
1296033|NCT00074269|Primary|Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)||100 days post transplant|study was closed early due to lack of accrual.|||Participants|||Count of Participants
1296034|NCT00074269|Primary|Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes|based on cell counts of ANC >1000 for 3 consecutive days and platelet count of >50,000|30 days post transplant|study was closed early due to lack of accrual.|||Participants|||Count of Participants
1296035|NCT00074269|Primary|Number of Participants With Adverse Events||5 years post transplant|study was closed early due to lack of accrual.|||Participants|||Count of Participants
1296036|NCT00074165|Secondary|Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment||2 years|||||||
1296037|NCT00074165|Secondary|Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment||2 years|||||||
1296038|NCT00074165|Secondary|Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months||5 years|||||||
1296039|NCT00074165|Secondary|Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression||5 years|||||||
1296040|NCT00074165|Secondary|Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response|Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.|5 years|Inadequate sample size to determine overall survival||||||
1296041|NCT00074165|Primary|Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.|Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.|2 years||||Participants|||Number
1296042|NCT00074152|Secondary|Sites of First Failures|Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow|5 years after randomization||||participants|||Number
1296043|NCT00074152|Secondary|Overall Survival||5 years after randomization||||percentage of participants||95% Confidence Interval|Number
1296044|NCT00074152|Primary|Disease-free Survival||5 years after randomization||||percentage of participants||95% Confidence Interval|Number
1296045|NCT00074035|Secondary|Pharmacokinetics||At initiation of Tx and at 3 months|||||||
1296046|NCT00074035|Secondary|Overall Survival At 2 Years|Percentage of patients who were alive at 2 years.|2 year||||percentage of participants|||Number
1296047|NCT00074035|Secondary|Overall Survival At 1 Year|Percentage of patients who were alive at 1 year.|1 year||||percentage of participants|||Number
1296048|NCT00074035|Secondary|Grade 3 or Higher Non-hematologic Adverse Events|Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.|Duration of treatment (up to 5 years)||||count of participants|||Number
1296049|NCT00074035|Primary|Response Rate|"Percentage of participants who had a complete or partial response defined by the Hopkins scoring system.~A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others."|3 months|3 patients died before the 3 month evaluation and were not evaluated for the primary endpoint|||percentage of participants|||Number
1296050|NCT00073983|Secondary|Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study|Blood samples for the determination of gemcitabine (and its metabolite dFdU) will be obtained prior to infusion, at 75 and 85 minutes (steady state), and 95 105 and 120 minutes, after the start of the 90 minute infusion on day 1 and day 8 of cycle 1. On day 8, docetaxel pharmacokinetics will be performed prior to infusion, 55 minutes (5 minutes prior to the end of infusion), 30 minutes post infusion, 5 hr and 24hr post infusion.|Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion.|There were insufficent samples obtained to analyze pharmacokinetics.|||participants|||Number
1296051|NCT00073983|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued.|Throughout the study|Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.|||participants|||Number
1296052|NCT00073983|Secondary|Time to Progression|Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria.|post-cycle 2, 4, 8 and 12|Analysis not completed. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.|||months|||Number
1296486|NCT00068341|Secondary|Clinico-histologic Predictors of pCR (Pathologic Complete Response)||5 years|ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), FISH (Fluorescence in situ hybridization), IDC (invasive ductal carcinoma), ILC (invasive lobular carcinoma),|||participants|||Number
1296053|NCT00073983|Primary|Objective Response Rate|Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.|After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days|Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.|||participants|||Number
1296054|NCT00073957|Secondary|Event Free Survival|the median time point at which a participants experienced and event or toxicity or progression|12 months||||months||Full Range|Median
1296055|NCT00073957|Primary|Best Response|This data is the best overall response achieved by patients by the 12 month period.|12 months||||Participants|||Count of Participants
1296056|NCT00073957|Primary|Response Rate = Complete and Partial Response at 12 Weeks.|Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node > 1 cm in short axis > 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy|12 weeks||||participants|||Number
1296057|NCT00073918|Secondary|Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0|Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%|From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years|Number of Grade 3-4 toxicities.|||events|||Number
1296058|NCT00073918|Secondary|Response Rate|Response rates will be estimated as the percentage of patients|From date of transplant through date of relapse/progression or death, assessed up to 15 years|Percentage of patients|||percentage of participants|||Number
1296059|NCT00073918|Secondary|5 Year Overall Survival|Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.|Up to 15 years||||percentage of participants|||Number
1296060|NCT00073918|Primary|Progression-free Survival|Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.|At year 3||||percentage of participants|||Number
1296061|NCT00073749|Other Pre-specified|Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)|Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.|Baseline up to 42 days after last dose of study drug (Day 225)|ITT population included all enrolled participants. Here ‘N’ signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.|||percentage of particpants||95% Confidence Interval|Number
1296062|NCT00073749|Other Pre-specified|Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)|Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.|Baseline up to 42 days after last dose (Day 225)|Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor CT scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of study.|||percentage of participants||95% Confidence Interval|Number
1296063|NCT00073749|Secondary|Time-to-Tumor Progression: Part 2 (Expanded Cohorts)|Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|"Evaluable population was analyzed. Here N signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 and Part 2 (Lead-in Cohort) of the study."|||days||95% Confidence Interval|Median
1296064|NCT00073749|Secondary|Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)|Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Evaluable population was analyzed. DoR included evaluable participants who achieved CR, CRu, or PR. Here ‘N’ signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.|||days||95% Confidence Interval|Median
1296065|NCT00073749|Secondary|Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)|Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR:>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Evaluable population was analyzed. Participants with diffuse or follicular lymphoma were analyzed. This outcome measure was not planned to be analyzed in Part 1 and Part 2 (Lead-in Cohort).|||participants|||Number
1296066|NCT00073749|Secondary|Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)|Interval OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline up to Year 5|ITT population included all enrolled participants. Here ‘N’ signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.|||days||95% Confidence Interval|Median
1296067|NCT00073749|Secondary|Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)|OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline up to Year 5|Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor CT scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of study.|||days||95% Confidence Interval|Median
1296068|NCT00073749|Secondary|Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)|PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Intent-to-treat (ITT) population included all enrolled participants. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.|||days||95% Confidence Interval|Median
1296069|NCT00073749|Secondary|Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)|PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor computed tomography (CT) scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This was not planned to be analyzed in Part 1 of study.|||days||95% Confidence Interval|Median
1296070|NCT00073749|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.|Baseline up to Day 28|Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. Here number of participant analyzed (N) signifies participants evaluable for this outcome measure.|||participants|||Number
1296081|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data|The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.|||scores on a scale||Standard Error|Mean
1296071|NCT00073749|Primary|Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.|Baseline up to Day 28|Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. This outcome measure was not planned to be analyzed in Part 2 of the study.|||milligram per meter square (mg/m^2)|||Number
1296072|NCT00073749|Primary|Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study. AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE). Participants with Grade 3 or higher grades TEAEs were reported.|Baseline up to 42 days after last dose of study drug (up to Day 225)|Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin.|||participants|||Number
1296073|NCT00073749|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs).|Baseline up to 42 days after last dose of study drug (up to Day 225)|Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin.|||participants|||Number
1296074|NCT00073528|Secondary|Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline|EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+).|Baseline|ITT Population|||participants|||Number
1296075|NCT00073528|Secondary|Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive|Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (>15 ng/mL) on two consecutive occasions.|Up to 46 months|HER2-Negative Population. Only those participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL were assessed.|||weeks||95% Confidence Interval|Median
1296076|NCT00073528|Secondary|Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive|Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL experienced seroconversion.|Up to 46 months|HER2-Negative Population: all randomized participants regardless of whether or not study treatment had been received and who at baseline were evaluated by the central laboratory to have retrospectively documented non-amplification or missing amplification of HER2 by FISH (<2.0) and documented IHC scores of 0, 1+, 2+, or missing in tumor tissue.|||participants|||Number
1296077|NCT00073528|Secondary|Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower|The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD.|Up to 46 months|HER2-Positive Population|||participants|||Number
1296078|NCT00073528|Secondary|Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity|IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =>6-month period.|Up to 46 months|ITT Population|||participants|||Number
1296079|NCT00073528|Secondary|Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status|Clinical benefit: participants with CR, PR, or SD for =>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present.|Up to 46 months|ITT Population|||participants|||Number
1296080|NCT00073528|Secondary|Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores|A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID => 8 for the FACT-B score, and an MID =>6 for the FACT-G and TOI scores.|Up to 46 months|HER2-Positive Population. Only those participants with a baseline score and at least one post-baseline score were assessed.|||participants|||Number
1297048|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 2|Percentage of participants with Viral Load < 50 copies/mL|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1296082|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data|FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.|||scores on a scale||Standard Error|Mean
1296083|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.|||scores on a scale||Standard Error|Mean
1296084|NCT00073528|Secondary|Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 [not at all] to 4 [very much]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B.|Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit|ITT Population|||participants|||Number
1296085|NCT00073528|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAEs) Related to Study Drug Reported by More Than One Participant in Either Treatment Arm|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Up to 46 months|Safety Population. Only those participants who experienced SAEs related to study drug that were reported by more than one participant in either treatment arm were assessed.|||participants|||Number
1296086|NCT00073528|Secondary|Number of Participants With the Indicated Adverse Events (AEs) Related to Study Treatment Reported in 10% or More Participants in Either Treatment Arm|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study treatment.|Up to 46 months|Safety Population: all randomized participants who had received at least 1 dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. All participants with any AE related to study treatment were assessed.|||participants|||Number
1296087|NCT00073528|Secondary|TTP for Participants From the ITT Population as Assessed by the Investigator|TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.|Up to 46 months|ITT Population. Only those participants who experienced disease progression or died due to breast cancer were assessed.|||weeks||95% Confidence Interval|Median
1296088|NCT00073528|Secondary|Number of Participants With Evidence of Brain Metastases From the ITT Population|The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.|Up to 46 months|ITT Population|||participants|||Number
1296089|NCT00073528|Secondary|Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|ITT Population. Only those participants with CR or PR response were assessed.|||weeks||Inter-Quartile Range|Median
1296090|NCT00073528|Secondary|Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|ITT Population. Only those participants with CR or PR were assessed.|||participants|||Number
1296091|NCT00073528|Secondary|Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator|CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.|Up to 46 months|ITT Population|||percentage of participants|||Number
1296487|NCT00068341|Secondary|Tumor Response Assessment|Measured by physical examination compared to breast mammography and MRI assessment|5 years|"pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for~1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]"|||participants|||Number
1296092|NCT00073528|Secondary|Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator|Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date.|Up to 46 months|ITT Population. Only those participants with some measurable disease were assessed. Response with bone scan confirmation was required. Participants with bone-only disease were excluded from the analysis because bone-only disease is non-measurable only per RECIST 1.0.|||participants|||Number
1296093|NCT00073528|Secondary|Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator|OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Up to 46 months|ITT Population. Only those participants who achieved either a confirmed CR or PR were assessed.|||percentage of participants|||Number
1296094|NCT00073528|Secondary|Overall Survival in the ITT Population|Overall survival was defined as the time from randomization until death due to any cause.|From date of randomization until date of death due to any cause, assessed up to 46 months|ITT Population. Only those participants who died during the study due to any cause were assessed.|||weeks||95% Confidence Interval|Median
1296095|NCT00073528|Secondary|Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator|TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.|Up to 46 months|HER2-Positive Population. Only those participants who experienced disease progression or died due to breast cancer were assessed.|||weeks||95% Confidence Interval|Median
1296096|NCT00073528|Secondary|Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population|The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.|Up to 46 months|HER2-Positive Population|||participants|||Number
1296097|NCT00073528|Secondary|Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|HER2-Positive Population. Only those participants with CR or PR were assessed.|||weeks||Inter-Quartile Range|Median
1296098|NCT00073528|Secondary|Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|HER2-Positive Population. Only those participants with CR or PR were assessed.|||participants|||Number
1296099|NCT00073528|Secondary|Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator.|CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.|Up to 46 months|ITT Population|||participants|||Number
1296100|NCT00073528|Secondary|Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator.|CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.|Up to 46 months|HER2-Positive Population|||participants|||Number
1296101|NCT00073528|Secondary|Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator|CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.|Up to 46 months|HER2-Positive Population|||percentage of participants|||Number
1296126|NCT00073021|Secondary|Percentage of Treatment Success Patients at Week 3, ITT Population|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|3 Weeks|ITT Patients with Moderate Disease [PGA = 2] at Baseline|||Percentage of Participants|||Number
1296102|NCT00073528|Secondary|Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator|Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date.|Up to 46 months|HER2-Positive Population. Only those participants with measurable disease, including bone scans, were assessed.|||participants|||Number
1296103|NCT00073528|Secondary|Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator|OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Up to 46 months|HER2-Positive Population|||percentage of participants|||Number
1296104|NCT00073528|Secondary|Overall Survival in the HER2-Positive Population|Overall survival was defined as the time from randomization until death due to any cause.|From date of randomization until date of death due to any cause, assessed up to 46 months|HER2-Positive Population. Only those participants who died during the study due to any cause were assessed.|||weeks||95% Confidence Interval|Median
1296105|NCT00073528|Secondary|PFS in Participants in the ITT Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|ITT Population. Only those participants who experienced disease progression or died during their participation in the study were assessed.|||weeks||95% Confidence Interval|Median
1296106|NCT00073528|Secondary|Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|ITT Population: all randomized participants, regardless of whether or not study treatment had been received. The ITT Population included the HER2-Positive Population, the HER2-Negative Population, and the HER2-Missing Population.|||participants|||Number
1296107|NCT00073528|Primary|Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|HER2-Positive Population. Only those participants who experienced disease progression or died during their participation in the study were assessed.|||weeks||95% Confidence Interval|Median
1296108|NCT00073528|Primary|Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Her3 as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months|HER2-Positive Population: all randomized participants who had documented amplification of baseline HER2 by fluorescence in situ hybridization (FISH) (=>2.0) or 3+ immunohistochemistry (IHC) (or 2+ IHC and FISH +) in archived tumor tissue regardless of whether or not study treatment had been received.|||participants|||Number
1296109|NCT00073333|Primary|Social Phobia Remission Rate at 6 Month Follow-up|Lack of SocialPhobia Diagnosis at 6 month follow-up|6 month follow up||||participants|||Number
1296110|NCT00073333|Secondary|Score on the SPAI||Measured at Month 12|||||||
1296111|NCT00073333|Primary|Social Phobia Remission||Measured at Month 12|||||||
1296139|NCT00073008|Secondary|Overall Survival|Overall survival is measured as the time from randomization until death due to any cause. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, overall survival was not analyzed.|From randomization and then every 8 weeks while on study drug and then every 3 months as follow-up until death|||||||
1296112|NCT00073307|Secondary|Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment|"Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from 0=not at all to 4=very much and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL."|From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.|Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1296113|NCT00073307|Secondary|Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment|"Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from 0=not at all to 4=very much and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL."|From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.|Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.|||Scores on a scale||Standard Error|Least Squares Mean
1296114|NCT00073307|Secondary|Best Overall Response - Independent Radiological Review|Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.|From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.|Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.|||percentage of participants|||Number
1296115|NCT00073307|Secondary|Final Progression-Free Survival (PFS) - Independent Radiological Review|PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.|From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.|Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment.|||days||95% Confidence Interval|Median
1296116|NCT00073307|Primary|Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.|From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later|Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of FU (last visit or contact or at data cut-off date). In case of incomplete date, missing day, day 15 was used. Placebo censored at 30June2005, approximate time of crossover of placebo subjects to sorafenib. NA - not estimable due to censored data.|||days||95% Confidence Interval|Median
1296117|NCT00073307|Primary|Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.|From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later|Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used.|||days||95% Confidence Interval|Median
1296118|NCT00073073|Secondary|Number of Serum and Breast Tissue Samples Collected for Exploratory Proteomic Profiles at One Year||1 year|Outcome not measured||||||
1296119|NCT00073073|Secondary|Effect of Exemestane on Autocrine Prolactin and Breast Tissue Prolactin Receptor at One Year||1 year|Outcome not measured||||||
1296120|NCT00073073|Secondary|Effect of This Drug on Breast Tissue Trefoil Factor 1 and Proliferating Cell Nuclear Antigen Expression, Prolactin, and Breast Tissue Prolactin Receptor at 1 Year||1 year|Change in breast tissue trefoil factor 1|||percent change from baseline||95% Confidence Interval|Mean
1296121|NCT00073073|Secondary|Absolute Change of Lipid Profiles on Exemestane From Baseline||1 year|Change in total cholesterol|||mg/dl||Standard Deviation|Mean
1296122|NCT00073073|Secondary|Effect of This Drug on Serum Hormones, Insulin-like Growth Factor Pathway Components, and Leptin at 3 Months and 1 Year||3 months and 1 year|Data were not collected||||||
1296123|NCT00073073|Secondary|Change in Breast Density at 2 Years||2 years||||percent change from baseline||95% Confidence Interval|Mean
1296124|NCT00073073|Secondary|Effect of This Drug on Bone Mineral Density||1 year||||percent change from baseline||95% Confidence Interval|Mean
1296125|NCT00073073|Primary|Percent Change in Mammographic Density at 1 Year on Exemestane||1 year||||percent change from baseline||95% Confidence Interval|Mean
1297054|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 64|Percentage of participants with Viral Load < 400 copies/mL|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1296127|NCT00073021|Secondary|Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|6 Weeks|All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Left Sided Disease = proctitis, proctosigmoiditis or left-sided colitis|||Percentage of Participants|||Number
1296128|NCT00073021|Secondary|Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients|IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better.|6 Weeks|All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.|||Scores on a Scale||Standard Error|Mean
1296129|NCT00073021|Secondary|Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients|IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better.|3 Weeks|All Randomized Patients with Moderate Disease[PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.|||Scores on a Scale||Standard Error|Mean
1296130|NCT00073021|Secondary|Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6|PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement.|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
1296131|NCT00073021|Secondary|Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6|PFA - 0=generally well, 1=fair, 2=poor, 3=terrible|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
1296132|NCT00073021|Secondary|Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6|Rectal Bleeding (0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed)|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
1296133|NCT00073021|Secondary|Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6|0=Normal stool frequency per day, 1=1-2 stools greater than normal per day, 2=3-4 stools greater than normal per day, 3=5 or more stools greater than normal per day|6 Weeks|ITT Patients with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
1296134|NCT00073021|Secondary|Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population|Sigmoidoscopy Assessment Score (0=normal intact vascular pattern, no friability or granularity, 1=mild erythema; diminished or absent vascular markings; mild granularity; friability, 2=moderate marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations, 3=severe spontaneous bleeding, ulcerations)|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
1296135|NCT00073021|Secondary|Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population|Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 0=normal (intact vascular pattern, no friability or granularity), 1=mild (erythema, diminished or absent vascular markings; mild granularity; friability), 2=moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations) 3=severe (spontaneous bleeding, ulcerations)|6 Weeks|ITT Patients with Moderate Disease [PGA=2] at Baseline. Percentage of patients whose rectal bleeding AND sigmoidoscopy scores BOTH improved from baseline at Week 6|||Percentage of Participants|||Number
1296136|NCT00073021|Secondary|Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population|UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]|6 weeks|ITT Population with Moderate Disease [PGA = 2] at Baseline.|||Scores on a Scale||Standard Error|Mean
1296137|NCT00073021|Primary|Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|6 Weeks|ITT Population with Moderate Disease [PGA = 2] at Baseline|||Percentage of Participants|||Number
1296138|NCT00073008|Secondary|Review of Non-small Cell Lung Cancer (NSCLC) Histology (Cell Type) Using an Independent Review|Comparison of the specific cell type (histology) of non-small cell lung cancer from participant’s tissue samples, as determined by local pathologist, to the type determined by an independent pathologist. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, NSCLC histology was not analyzed.|Anytime from Baseline through end of study|||||||
1296488|NCT00068341|Secondary|Clinical Tumor Response by Physical Exam and Imaging Studies||5 years|Clinical response was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]|||participants|||Number
1296140|NCT00073008|Secondary|Time to Tumor Progression|Time from randomization until the first documented sign of disease progression or death due to any cause, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to tumor progression was not analyzed.|From randomization and then every 8 weeks to disease progression or death|||||||
1296141|NCT00073008|Secondary|Duration of Response|For those participants who show a complete or partial response, duration of response would be time from first documented evidence of response (complete or partial response by RECIST) until disease progression or death, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, duration of response was not analyzed.|Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death|||||||
1296142|NCT00073008|Secondary|Time to Response|Time from randomization until first documented evidence of partial or complete tumor response, measured using standard criteria (RECIST). Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to response was not analyzed.|From randomization and then every 8 weeks to time of response to study drug|||||||
1296143|NCT00073008|Secondary|Quality of Life|Standard survey forms were completed by the participant at scheduled assessments to find out how the participant felt while on study. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, quality of life was not analyzed.|Baseline and then every 4 weeks through end of treatment|||||||
1296144|NCT00073008|Secondary|Pharmacogenetics (PgX)|To (1) investigate the relationship between genetic variants in specific genes and the absorption, distribution, metabolism, and excretion (pharmacokinetics) of lapatinib, and to (2) investigate the relationship between genetic variants in select genes in DNA and the response (safety, efficacy, and tolerability) to lapatinib. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacogenetics were not analyzed.|From randomization at every 4-week assessment through end of treatment|||||||
1296145|NCT00073008|Secondary|Pharmacokinetics (PK) of Lapatinib|To characterize the PK (absorption, distribution, metabolism, and excretion) of the study drug lapatinib in the participant population. PK is defined as the concentration of drug in a participant’s blood at certain time points after the drug was taken by mouth. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacokinetics were not analyzed.|From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug|||||||
1296146|NCT00073008|Secondary|The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue|To further characterize the participant population, these biomarkers could be tested: serum levels of ErbB1 and ErbB2; intra-tumoral expression of ErbB1, ErbB2, etc.; mutations in ErbB1, ErbB2, and k-ras. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, serum biomarkers were not analyzed.|From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples|||||||
1296147|NCT00073008|Secondary|Progression-free Survival (PFS) at Four Months in the Non-Targeted Population|Percentage of participants in the Non-Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.|From randomization and then every 8 weeks up to four months|Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.|||percentage of participants|||Number
1296148|NCT00073008|Secondary|Progression-free Survival (PFS) at Four Months in the Targeted Population|Percentage of participants in the Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.|From randomization and then every 8 weeks up to four months|Targeted Population|||percentage of participants|||Number
1296149|NCT00073008|Other Pre-specified|Tumor Response in the Non-Targeted Population Through the End of Treatment|Baseline and then every 8 weeks through end of treatment (end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event or participant decision)|Baseline and then every 8 weeks through end of treatment|Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.|||participants|||Number
1296150|NCT00073008|Primary|Tumor Response in the Targeted Population Through the End of Treatment|Disease progression and tumor response (number of participants achieving a complete response [CR] or partial response [PR]), using standardized criteria (Response evaluation criteria in solid tumors). CR, disappearance of all target lesions; PR, 30% decrease in the sum of the longest diameter of target lesions; progressive disease, 20% increase in the sum of the longest diameter of target lesions; stable disease, small changes that do not meet above criteria. Disease assessment was done at baseline and then every 8 weeks after starting treatment, until the participant discontinued treatment.|Baseline and then every 8 weeks through end of treatment|Targeted Population: all randomized participants who received at least one dose of study drug and had either the histological subtypes of adenocarcinoma with bronchioloalveolar carcinoma features or pure bronchioloalveolar carcinoma, or were never smokers with any histology of non-small cell lung cancer (NSCLC)|||participants|||Number
1296165|NCT00072384|Primary|Group C Eyes - Treatment Failure Within One Year|"Each Group C eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the Mean measure type."|One year|Four eligible patients had at least one Group C eye to contribute to the analysis|||Probability of treatment failure|Eyes|Standard Deviation|Mean
1296503|NCT00068107|Secondary|Number of Participants With a Change in Quantitative Sudomotor Axon Reflex Test|Quantitative sudomotor axon reflex test (QSART) is a measure of sweat function|Baseline and last observation (up to 10 years)||||participants|||Number
1296151|NCT00072761|Primary|Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct|The primary end point was the recurrence of infarct or hemorrhage as determined by neuroimaging, clinical evidence of permanent neurologic injury, or both. A new infarct had to meet the criteria for a silent cerebral infarction; an enlarged silent cerebral infarct was defined as a previously identified silent cerebral infarct that increased by at least 3 mm along any linear dimension in any plane on MRI.|From study entry to study exit|Randomization assignments were provided by the statistical data coordinating center with the use of a permuted block design, with stratification according to site, age, and sex. Participants were assigned in a 1:1 ratio to the observation or transfusion group and were followed until study exit or study endpoint.|||infarct recurrence per 100 person years|||Number
1296152|NCT00072475|Primary|Time to Transformation to AML|Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
1296153|NCT00072475|Secondary|Progression-free Survival|"Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.~Progression is defined as~For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts~For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts~For patients with 10-19% bone marrow blasts: increase to ≥20% blasts~One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC < 1.5 K/L or PLT< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent~Progression after HI: Includes one or more of the following~Decrement of 50% or greater from maximum response levels in ANC < 1.5 K/L or PLT < 100 K/L~Reduction in HGB concentration by at least 2 g/dL~Becoming transfusion dependent"|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
1296154|NCT00072475|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
1296155|NCT00072475|Secondary|Duration of Response|"Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method.~Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure)."|5 yrs|Per the description, only patients who achieved a response were evaluable for this outcome.|||months||95% Confidence Interval|Median
1296156|NCT00072475|Primary|Number of Participants With Response|"Response was measured by International Standardized Response Criteria for MDS~Complete Response: Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines; Hgb > 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia~Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant.~Hematologic improvement:~Erythroid (HI-E): For participants with baseline HGB < 11g/dL, Major: > 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements~Platelet (HI-P): For participants with baseline PLT < 100 K/L: Major: absolute increase of > 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of >10 K/L)~Neutrophil (HI-N): For participants with baseline ANC < 1.5 K/L, Major: > 100% increase (net increase > 0.5 K/L). Minor: > 100% increase (absolute increase < 0.5 K/L)"|Duration of study (up to 5 years)||||participants|||Number
1296157|NCT00072449|Secondary|Toxicity|patients only received drug for 8 weeks|8 weeks - 2 cycles||||related episodes|||Number
1296158|NCT00072449|Secondary|Overall Survival|survival was evaluated q 2months|47 months||||months||95% Confidence Interval|Median
1296159|NCT00072449|Secondary|Progression-free Survival|pt had MRI every 3 months|pt had MRI q3months||||days||95% Confidence Interval|Median
1296160|NCT00072449|Primary|Radiographic Response|it at any time point patient progresses no more scans are required, patient is off study|1 month, 2 months and then q3months||||participants|||Number
1296161|NCT00072384|Secondary|Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement|The association between the probability of experiencing treatment failure vs. no failure in a C eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia. The association between the probability of experiencing treatment failure vs. no failure in a D eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia.|From the date of enrollment assessed up to 12 months|According to the initial sites of involvement, 4 patients were analyzed in Group C eyes and 20 patients were analyzed for Group D eyes|||Eyes|||Number
1296162|NCT00072384|Secondary|Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence|Sites of disease recurrence for Group C and Group D eyes where treatment failure was detected|From the date of enrollment assessed up to 36 months|1 patient had at least one Group C eye and 11 patients had at least one Group D eye that experienced treatment failure. There were a total of 13 Group D eyes that experienced treatment failure.|||Eyes|||Number
1296163|NCT00072384|Secondary|Toxicity Associated With Chemotherapy|The number of patients that experience CTC Version 4 grade 3 or higher toxicities of any kind.|From date of enrollment until termination of protocol therapy assessed up to 72 weeks|22 eligible patients were evaluable for the occurrence of grade 3 or higher toxicity of any kind.|||Patients|||Number
1296164|NCT00072384|Secondary|Event-free Survival (EFS)|Proportion of patients event free at 1 year following enrollment. Event free survival time is computed as the time to study entry until disease relapse/progression, secondary malignancy, or death.|One year after study enrollment|22 eligible patients were considered for this endpoint.|||Percentage probability||95% Confidence Interval|Number
1296312|NCT00070317|Primary|Sensitivity|Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.|At the time of surgery|Eligible and evaluable patients with lymph node metastasis and identified sentinel node|||Percentage of participants||90% Confidence Interval|Number
1296166|NCT00072384|Primary|Group D Eyes - Treatment Failure Within One Year|"Each Group D eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the Mean measure type."|One year|Twenty eligible patients had at least one Group D eye to contribute to the analysis. A total of 25 Group D eyes were available for analysis.|||Probability of treatment failure|Eyes|Standard Deviation|Mean
1296167|NCT00072293|Secondary|Site of Recurrence|Site of recurrence of breast cancer|Reported after a median follow-up of 60 months|Intention-to-treat|||participants|||Number
1296168|NCT00072293|Secondary|5-year Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.|5-year estimate reported after a median follow-up of 60 months|Intention-to-treat|||percentage of participants|||Number
1296169|NCT00072293|Primary|5-year Disease-Free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.|5-year estimate reported after a median follow-up of 60 months|Intention-to-treat|||percentage of participants|||Number
1296170|NCT00072280|Primary|"Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm"|Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).|Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)|By protocol design, only eligible patients were considered in the evaluation for the primary outcome measure. One (1) patient was found ineligible, leaving two (2) for the analysis population.|||participants|||Number
1296171|NCT00072189|Secondary|Progression-free Survival|"Estimated using the product-limit method of Kaplan and Meier.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|From the date of study registration to the first documentation of progressive tumor, assessed up to 7 years||||months||95% Confidence Interval|Median
1296172|NCT00072189|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 7 years||||months||95% Confidence Interval|Median
1296173|NCT00072189|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 7 years||||percentage of responding participants|||Number
1296174|NCT00072176|Primary|Progression-free Survival (Tumor Progression)|Time to tumor progression or death|5 years|All patients who were evaluable for response|||months||95% Confidence Interval|Median
1296175|NCT00072176|Primary|Objective Clinical Response Rate|Defined as proportion of patients with 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response) and confirmed on independent radiology review.|Up to 5 years|Patients who were evaluable for response.|||percentage of patients with response||95% Confidence Interval|Number
1296176|NCT00071981|Secondary|Median Overall Survival (OS)|OS was defined as the time from registration to death from any cause.|assessed every 3 month within 2 years and every 6 months betwen 2 and 5 years|148 eligible and treated patients were included in the analysis|||months||95% Confidence Interval|Median
1296177|NCT00071981|Secondary|Objective Response Rate|Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate is calculated as the number of patients with complete response (disappearance of all lesions) or partial response () divided by total number of evaluable patients.|Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination|148 eligible and treated patients were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1296178|NCT00071981|Secondary|Helper T Cell Response to Tetanus|Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.|Immune response was assessed at pre-registration, in weeks 1,3,5,7,8|128 eligible and treated patients who had data about HTL response to tetanus peptide were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1296179|NCT00071981|Secondary|Helper T-cells Response to 6MHP|Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.|Immune response was assessed at pre-registration, in weeks 1,3,5,7,8|128 eligible and treated patients who had data about helper T cell response were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1296180|NCT00071981|Primary|Cytotoxic T-cell Lymphocytes (CTL) Response Rate|Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.|Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8|140 eligible and treated patients who had CTL response data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1296181|NCT00072566|Secondary|Median Overall Survival|Calculated using the method of Kaplan-Meier.|Time from first day of treatment to time of death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
1296313|NCT00070291|Secondary|Overall Survival|Overall survival was defined as time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 1 year.|all 4 enrolled patients|||Months||95% Confidence Interval|Median
1296504|NCT00068107|Secondary|Globotriaosylceramide (Gb(3)) in Urine Sediment||Baseline and last observation (up to 10 years)||||nanomole/(gram of Creatinine)|||Number
1296182|NCT00072566|Secondary|Response Rate Based on the RECIST|Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.|Up to 3 years||||percentage of responding patients|||Number
1296183|NCT00072566|Primary|Median Time to Progression|Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.|Up to 3 years||||months||95% Confidence Interval|Median
1296184|NCT00072514|Secondary|Peripheral Blood Stem Cell Collection|Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.|Up to 12 weeks|Successful PBSC collection is only considered in those patients that attempted PBSC collection.|||Participants|||Count of Participants
1296185|NCT00072514|Secondary|Hematologic and Non-hematologic Adverse Events.|Count of participants with grade 3/4 hematologic and non-hematologic adverse events.|3-4 weeks after completion of study treatment||||Participants|||Count of Participants
1296186|NCT00072514|Secondary|Overall and Complete Response Rates|Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin’s lymphomas. J Clin Oncol 1999;17:1244–1253.)|3-4 weeks after completion of study treatment||||percentage of participants||95% Confidence Interval|Number
1296187|NCT00072514|Primary|Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules|Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.|At 3-4 weeks after completion of study treatment||||Participants|||Count of Participants
1296188|NCT00071812|Other Pre-specified|Adverse Events (AE) Overview|Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 48/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBRA99/NCT00583557).|Up to 56 weeks||||percentage of participants|||Number
1296189|NCT00071812|Secondary|Mean Change in Modified Total Sharp Score at Week 24|The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a modified total Sharp score at baseline and at Week 24.|||scores on a scale||Standard Error|Mean
1296190|NCT00071812|Secondary|Time to First DAS28 Response|DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a “good” or a “moderate” improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as >1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and > 0.6 with a DAS28 score of > 5.1.|0 to 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||days||Full Range|Median
1296191|NCT00071812|Secondary|Mean Change in Disease Activity Score 28 (DAS28) at Week 24|DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (>5.1=active disease; <3.2=well controlled disease; <2.6=remission). Change from baseline >1.2 = good response and ≤0.6 = non-response.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a baseline and a Week 24 DAS28 score.|||scores on a scale||Standard Error|Mean
1296192|NCT00071812|Secondary|Time to First ACR70 Response, Based on ESR|Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study.|0 to 24 weeks|||||||
1296193|NCT00071812|Secondary|Time to First ACR50 Response, Based on ESR|Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study.|0 to 24 weeks|||||||
1296194|NCT00071812|Secondary|Time to First ACR20 Response, Based on ESR|The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24.|0 to 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||days||Inter-Quartile Range|Median
1296195|NCT00071812|Secondary|Percentage of Patients With an ACR70 Response at Week 24, Based on ESR|An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percentage of participants|||Number
1296196|NCT00071812|Secondary|Percentage of Patients With an ACR50 Response at Week 24, Based on ESR|An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percentage of participants|||Number
1296197|NCT00071812|Primary|Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)|An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percentage of participants|||Number
1296198|NCT00071799|Primary|Number of Participants Who Died|Count of participants who died during the study|42 months|Intent to treat population|||participants|||Number
1296199|NCT00071799|Post-Hoc|Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML) Based on the Last Bone Marrow Assessment|A sensitivity analysis of time to transformation to AML during the entire study was performed based on the last bone marrow assessment. Patients were censored based on the last bone marrow assessment.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.|||months||95% Confidence Interval|Median
1296200|NCT00071799|Secondary|Number of Participants in Different Categories of Adverse Experiences During Core Study Period|Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.|Day 1 (randomization) to 42 months|Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.|||participants|||Number
1296201|NCT00071799|Secondary|Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals|The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years. The on-treatment period was considered the period from the date of randomization to the last treatment study visit.|Day 1 (randomization) to 42 months|Intent to treat population|||infections per treatment year|||Number
1296202|NCT00071799|Secondary|Duration of Any Hematologic Improvement|The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.|Day 1 (randomization) to 42 months|Intent to treat population. Participants showing hematologic improvement were 48 in azacitidine and 31 in conventional care.|||months||95% Confidence Interval|Median
1296203|NCT00071799|Secondary|Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause|The time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, or death from any cause.|Day 1 (randomization) to 42 months|Intent to treat population. The number of participants with disease progression, relapse after remission or death from any cause is 84 for azacitidine and 79 for conventional care. Remaining participants were censored.|||months||95% Confidence Interval|Median
1296204|NCT00071799|Secondary|Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee|"IWG 2000 Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L.~Erythroid response: Major->20g/L increase or transfusion independent. Minor- 10-20g/L increase or >=50% decrease in transfusion requirements.~Platelet response: Major-absolute increase of >=30x10^9/L or platelet transfusion independence. Minor->=50% increase.~Neutrophil response: Major->=100% increase or an absolute increase of >0.5x10^9/L. Minor->=100% increase and absolute increase of <0.5x10^9/L."|Day 1 to 42 months|Intent to treat population.|||participants|||Number
1296205|NCT00071799|Secondary|Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)|"Investigator determined responses followed IWG criteria for~complete remission(CR): repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia~partial remission(PR) is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment~stable disease(SD) is a failure to achieve at least a partial remission, but with no evidence of progression for at least 2 months."|Day 1 to 42 months|Intent to treat population.|||participants|||Number
1296206|NCT00071799|Secondary|Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline|Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population|||participants|||Number
1296207|NCT00071799|Secondary|Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population|||participants|||Number
1296352|NCT00069823|Secondary|Exacerbation Components: Urgent Care Visit||Measured at Month 6||||events per person-year|||Number
1296353|NCT00069823|Secondary|Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days||Baseline to 24 Weeks||||events per person-year|||Number
1296505|NCT00068107|Secondary|Globotriaosylceramide (Gb(3)) in Plasma||Baseline and last observation (up to 10 years)||||nanomole/mL|||Number
1296208|NCT00071799|Secondary|Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline|Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population|||participants|||Number
1296209|NCT00071799|Secondary|Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population|||participants|||Number
1296210|NCT00071799|Secondary|Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)|The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.|||months||95% Confidence Interval|Median
1296211|NCT00071799|Secondary|Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First|The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who either transformed to AML or died are 120 for azacitidine and 132 for conventional care. Remaining participants were censored.|||months||95% Confidence Interval|Median
1296212|NCT00071799|Primary|Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause|"Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.~Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification."|Day 1 (randomization) to 42 months|Intent to treat population. Includes participants who died and those who were censored.|||months|||Number
1296213|NCT00071799|Primary|Kaplan-Meier Estimates for Median Time to Death From Any Cause|Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.|Day 1 (randomization) to 42 months|Intent to treat population. Includes participants who died and participants who were censored.|||months|||Number
1296214|NCT00071890|Secondary|AIDS Events|AIDS defined events according to CDC classification|Overall study|"IL-2 arm : Oesophageal candidasis at W196~Control arm :Ocular B-cell lymphoma at W43,Oesophageal candidasis at W82, B-cell lymphoma at W104"|||event|||Number
1296215|NCT00071890|Secondary|Changes in CD4 Counts at Week 72||week 72||||cells per mm3||Inter-Quartile Range|Median
1296216|NCT00071890|Primary|Proportion of Patients Without Failure of Strategy From Week 0 to Week 72|"A failure of strategy is defined on the first occurrence of one of the following events:~CD4 T-lymphocyte count becomes < 350 cells/mm3 between Wk0 and Wk72 (count confirmed by a 2nd measurement after 2-4 weeks~Planned interruption of therapy at Wk24 cannot be done for any reason;~Anti-retroviral treatment is restarted between Wk24 and Wk72 for any reason~Subject experiences clinical progression of HIV infection to a stage C AIDS diagnosis (appendix I)~Subject expires between Wk0 and Wk72 (whatever the cause of death)~Subject is lost to follow up"|week 72|Intent to treat analysis, missing = failure.|||Pourcentage||95% Confidence Interval|Number
1296217|NCT00071760|Secondary|Plasma FPV CL/F Expressed in mL/Min|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1296218|NCT00071760|Secondary|Plasma FPV CL/F Expressed in mL/Min/kg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1296219|NCT00071760|Secondary|Plasma FPV Cmax and Cτ|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1296220|NCT00071760|Secondary|Plasma FPV AUC (0-τ)|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
1296221|NCT00071760|Secondary|Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events|No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.|Week 48|PK Population||||||
1296222|NCT00071760|Secondary|Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child’s Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10|Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian’s perception of the child’s assessment of the oral suspension (Items: 5=reaction to new medicine [med.]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like.|Weeks (W) 2, 24, and 48/premature study discontinuation|Safety Population|||participants|||Number
1296223|NCT00071760|Secondary|Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4|P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G’s perception of the child’s assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit.|Weeks 2, 24, and 48/premature study discontinuation|Safety Population|||participants|||Number
1296224|NCT00071760|Secondary|Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire|A separate questionnaire were administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Question 5 queried about the number of doses of FPV or RTV missed since the participant’s last study visit. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.|Weeks 2, 12, 24, and 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1296225|NCT00071760|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Baseline through Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable|||participants|||Number
1296226|NCT00071760|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|Baseline through Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.|||participants|||Number
1296227|NCT00071760|Secondary|Plasma RTV CL/F Expressed in mL/Min|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).|Week 48|PK Population. Only those participants contributing data were analyzed.|||mL/min||95% Confidence Interval|Geometric Mean
1296228|NCT00071760|Secondary|Plasma RTV CL/F Expressed in mL/Min/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.|||mL/min/kg||95% Confidence Interval|Geometric Mean
1296229|NCT00071760|Secondary|Plasma RTV Cτ|The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
1296230|NCT00071760|Secondary|Plasma RTV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
1296231|NCT00071760|Secondary|Plasma Ritonavir (RTV) AUC (0-τ)|Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted PK analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.|Week 48|PK Population. Only those participants contributing data were analyzed.|||hr*µg/mL||95% Confidence Interval|Geometric Mean
1296232|NCT00071760|Secondary|Number of Participants With the Indicated Virological Outcome at Week 48|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.).|Week 48|ITT-E Population. Only those participants contributing data were analyzed.|||participants|||Number
1296233|NCT00071760|Secondary|Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. Not all participants had values at both baseline and the indicated time points; thus, change from baseline could not be calculated for all participants.|||Percentage of cells||Inter-Quartile Range|Median
1296234|NCT00071760|Secondary|Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.|||Percentage of cells||Inter-Quartile Range|Median
1296235|NCT00071760|Secondary|Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the MSD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1296236|NCT00071760|Secondary|Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.|||log10 copies/mL||Inter-Quartile Range|Median
1296237|NCT00071760|Secondary|Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.|||log10 copies/mL||Inter-Quartile Range|Median
1296238|NCT00071760|Secondary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation=Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 4, 12, 24, 36, and 48|Intent-to-Treat Exposed (ITT-E) Population: participants who received chronic therapy with FPV or FPV/RTV at any dose. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1296239|NCT00071760|Primary|Number of Participants Who Permanently Discontinued the Treatment Due to an AE|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline (Day 1) until Week 48|Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.|||participants|||Number
1296240|NCT00071760|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.|Baseline (Day 1) until Week 48|Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.|||participants|||Number
1296241|NCT00071760|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities|TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Neutropenia is a decrease (d) in the number of Ns, d/increase (I) in glucose is hypo (Hp)/hyper (Hy)glycemia, in potassium is Hp/Hykalemia, and in sodium is Hp/Hynatremia. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.|Baseline (Day 1) until Week 48|Safety Population. Only those participants contributing data were analyzed.|||participants|||Number
1296242|NCT00071760|Primary|Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48|Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, and 48|Safety Population. Only those participants contributing data were analyzed.|||Units per liter (U/L)||Inter-Quartile Range|Median
1296243|NCT00071760|Primary|Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48|Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48|Safety Population. Only those participants contributing data were analyzed.|||Millimoles per liter (mmol/L)||Inter-Quartile Range|Median
1296978|NCT00056407|Secondary|Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms|Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit.|Years 1-2, Overall (Years 1-4)|Efficacy Population|||participants|||Number
1296244|NCT00071760|Primary|Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48|Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in ALT and AST was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48|Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.|||International units per liter (IU/L)||Inter-Quartile Range|Median
1296245|NCT00071760|Primary|Plasma Unbound APV Percent Protein Binding (%Cτ)|Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Percentage of total APV Cτ unbound||Standard Deviation|Mean
1296246|NCT00071760|Primary|Plasma Unbound APV Cτ|"Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or free APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state."|Week 48|PK Population. Only those participants contributing data were analyzed.|||µg/mL||Standard Deviation|Mean
1296247|NCT00071760|Primary|Plasma APV CL/F Following Dosing Expressed in mL/Min|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).|Week 48|PK Population. Only those participants contributing data were analyzed.|||mL/min||95% Confidence Interval|Geometric Mean
1296248|NCT00071760|Primary|Plasma APV CL/F Following Dosing Expressed in mL/Min/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Milliliters/minute/kilogram (mL/min/kg)||95% Confidence Interval|Geometric Mean
1296249|NCT00071760|Primary|Plasma APV Cτ|The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1296250|NCT00071760|Primary|Plasma APV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Least Squares Mean
1296251|NCT00071760|Primary|Plasma Amprenavir (APV) AUC (0-tau[τ])|"Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr."|Week 48|Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.|||Hr per microgram/milliliter (hr*µg/mL)||95% Confidence Interval|Geometric Mean
1296252|NCT00071721|Secondary|Participant’s Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)|ADCS-Clinical Global Impression of Change (ADCS-CGIC) provides a means to reliably assess global change from baseline. It provides a semi-structured format to allow clinicians to gather necessary clinical information from both the participant and informant, in order to make an overall impression of clinical change. The range of this instrument is 1 to 7 with lower numbers indicating improvement and higher numbers indicating a worsened state.|24 months||||Units on a scale||Standard Deviation|Mean
1296253|NCT00071721|Secondary|Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version|The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver rating questionnaire for the assessment of agitation in older persons. It includes descriptions of 29 agitated behaviors, each rated on a 7-point scale of frequency. The range of this instrument is 29 to 203 with higher numbers indicating greater impairment.|24 months||||Units on a scale||Standard Deviation|Mean
1296254|NCT00071721|Secondary|Global Severity of Dementia Using the CDR Sum of Boxes|Clinical Dementia Rating, Sum of Boxes (CDR-SOB) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.|24 months||||Units on a scale||Standard Deviation|Mean
1296255|NCT00071721|Secondary|Functional Performance Assessed by the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory|Alzheimer's Disease Cooperative Study Activities of Daily Living Score (ADCS-ADL) is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.|24 months||||Units on a scale||Standard Deviation|Mean
1296256|NCT00071721|Secondary|Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)|Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year (ADAS-cog) is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.|24 months||||Units on a scale||Standard Deviation|Mean
1296257|NCT00071721|Primary|Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician|NPI quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, and others. This is a questionnaire administered to the subject's study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment. To determine whether or not psychosis or agitation is present, there is no cutoff score but is based on the clinician’s judgment. In the NPI, the subject responds to ‘Yes’ or ‘No’ questions. Then it is determined how often psychosis or agitation occurs and if it is mild, moderate or severe.|24 months||||Participants|||Number
1296258|NCT00071513|Secondary|School Attachment|"School attachment measure consisted of 4 items. Item responses range from 0 (unsatisfied, rarely attended, not involved, etc.) to 6 (highly satisfied, regularly attended, very involved, etc). Scores could range from 0 to 36 with higher scores indicating more positive school attachment. Item were:~My overall satisfaction with classes was… Overall, how safe did school feel last semester… Overall, how friendly did school feel… How involved were you in school activities…"|18 months|T-test differences for HSTS versus Brief Intervention on the School Attachment scale.|||units of a scale||Standard Deviation|Mean
1296259|NCT00071513|Primary|Change in Short Moods and Feelings Questionnaire (SMFQ)|"The Short Moods and Feelings Questionnaire is a 13 item measure of level of self reported depressive symptoms. Each item in scored on a 3-point Likert scale as follows: True (0), Sometimes (1), and Not True (2) rated within the timeframe of the previous two weeks. A total score is obtained; scores can range from 0 to 26. Total scores of 12 or higher may signify that a child/adolescent is suffering from depression. Higher scores on this scale suggest a worse outcome or greater endorsement of depressive symptoms. Change is measured based on two time points baseline to the 18 months follow-up assessment."|Baseline to 18 months|The main study hypothesis was that at-risk middle school students randomly assigned to participate in the CAST-T/HSTS versus the Brief Intervention would demonstrate a greater reduction in self-reported depressive symptoms after the 8th grade intervention as well as lower rate of increase in depressive symptoms at the 18 mos. follow-up.|||units on a scale||Standard Deviation|Mean
1296260|NCT00071487|Other Pre-specified|Adverse Events (AE) Overview|Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).|Up to 84 weeks||||percentage of participants|||Number
1296261|NCT00071487|Secondary|Percentage of Patients With a Reduction in Prednisone Dose|Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.|Baseline, weeks 40 to 52|Analysis was performed on a subgroup of the MITT population, which included only patients with baseline prednisone dose > 7.5 mg/day.|||percentatge of particpants|||Number
1296262|NCT00071487|Secondary|Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks|SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.|0 to 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||days||Inter-Quartile Range|Median
1296263|NCT00071487|Secondary|Area Under the Curve (AUC) of BILAG Score at Week 52|The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.|Baseline and every 4 to 8 weeks through Week 52|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||ratio score*days||Standard Error|Mean
1296264|NCT00071487|Secondary|Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52|The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.|Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percent change||Standard Error|Mean
1296265|NCT00071487|Secondary|Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.|Baseline and every 4 to 8 weeks through Week 52|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||ratio score*days||Standard Error|Mean
1296266|NCT00071487|Secondary|Percentage Change From Baseline in SELENA SLEDAI Score at Week 52|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare|Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percent change||Standard Error|Mean
1296267|NCT00071487|Primary|Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)|"The SLE Flare Index categorized SLE flare as mild or moderate or severe based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe)."|0 to 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||days||Inter-Quartile Range|Median
1296268|NCT00071487|Primary|Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percent change||Standard Error|Mean
1296269|NCT00071396|Primary|Overall Response|Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.|After each 4 week course of treatment|Analysis treated population 41 evaluable patients (44 treated, 3 not evaluable for response).|||Participants|||Number
1296270|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) from baseline to post-intervention across treatment group. Minimum Score = 0 (more); Maximum Score = 100 (less). Positive Mean Change scores indicate improvement (an increase in scale score/less pain).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.|||Units on a scale||Standard Deviation|Mean
1296271|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better) , Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.|||Units on a scale||Standard Deviation|Mean
1296272|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) PHYSICAL Component Score (MOSPCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better), Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score/better).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.|||Units on a scale||Standard Deviation|Mean
1296273|NCT00071110|Primary|Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10|Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.|Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.|||participants|||Number
1296274|NCT00071032|Secondary|Composite Outcomes (a) Death, Myocardial Infarction, and Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism and Stroke)||In-hospital|||||||
1296275|NCT00071032|Secondary|Myocardial Infarction||In-hospital|||||||
1296276|NCT00071032|Secondary|Length of Stay in Hospital||In-hospital|||||||
1296277|NCT00071032|Secondary|Function (e.g., Lower Extremity Activities of Daily Living, Instrumental Activities of Daily Living, Fatigue/Energy)||30 and 60 days|||||||
1296278|NCT00071032|Secondary|Disposition Status (i.e., Nursing Home Placement)||60 days|||||||
1296279|NCT00071032|Secondary|Survival||30-daym, 60- day and long term up to 5 years|||||||
1296280|NCT00071032|Secondary|Postoperative Complications (e.g., Pneumonia, Wound Infection, Thromboembolism, Stroke)||In hospital|||||||
1296281|NCT00071032|Secondary|Myocardial Infarction, Unstable Angina, or Death for Any Reason||In-hospital||||participants|||Number
1296282|NCT00071032|Primary|Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death|ascertained via telephone follow-up|60 days after randomization||||participants|||Number
1296283|NCT00071006|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least every 3 months after discontinuation of study treatment|Analysis for this particular endpoint was not conducted due to lack of efficacy.|||Days||95% Confidence Interval|Median
1296284|NCT00071006|Secondary|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose) and every 4 weeks up to 35 weeks|||||||
1296285|NCT00071006|Secondary|Plasma Vascular Endothelial Growth Factor (VEGF) Concentration|VEGF promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Plasma VEGF concentration evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot.|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Data was not summarized for this particular endpoint due to lack of efficacy.|||pg/mL||Standard Deviation|Mean
1296286|NCT00071006|Secondary|Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation|Vascular endothelial growth factor (VEGF) promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Mononuclear (MNC) cell VEGF receptor expression and phosphorylation was assessed by in situ western blot analysis. VEGFR-1 and VEGFR-2 evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot.|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Data was not summarized for this particular endpoint due to lack of efficacy.|||picograms (pg)/mL||Standard Deviation|Mean
1296287|NCT00071006|Secondary|Bone Marrow Micro Vessel Density (MVD)|Bone marrow MVD in tumors is a measure of angiogenesis and a prognostic indicator that correlates with an increased risk of metastasis in various cancers and with overall and relapse free survival in participants with AML or MDS. Bone marrow biopsies and bone marrow clot samples were assessed for MVD (cluster of differentiation 31 [CD31] staining).|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks|Data was not summarized for this particular endpoint due to lack of efficacy.|||vessels/square millimeter (mm^2)||Standard Deviation|Mean
1296288|NCT00071006|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.|First documentation of objective response until objective disease progression or discontinuation from the study due to any cause assessed every 4 weeks up to 35 weeks|Analysis for this particular endpoint was not conducted due to lack of efficacy.|||Days||95% Confidence Interval|Median
1296289|NCT00071006|Secondary|Percentage of Participants With Hematologic Improvement (HI)|HI was described by the number of individual and positively affected cell lines (Erythroid response, Platelet response, Neutrophil response). Improvements must last at least 2 months.|Baseline, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Analysis for this particular endpoint was not conducted due to lack of efficacy.|||Percentage of participants||95% Confidence Interval|Median
1296290|NCT00071006|Primary|Percentage of Participants With Objective Response (OR)|Participants with OR based on a assessment of confirmed complete remission (CR) or partial remission (PR) according to Cheson criteria for Acute myeloid leukemia (AML) and Myelodysplastic syndrome (MDS). CR: those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood value lasting at least 1 month and 2 months for AML and MDS respectively. PR : those with all criteria for CR except 5-25 % blasts in bone marrow and at least 50% decrease in blast over pretreatment for AML and MDS respectively.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 4 weeks up to 35 weeks|Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.|||Percentage of participants||95% Confidence Interval|Number
1296291|NCT00070941|Primary|Change in Hamilton Depression Scale|very severe, >23/29; severe, 19–22/29; moderate, 14–18/29; mild, 8–13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)|12 weeks||||units on a scale||Standard Deviation|Mean
1296292|NCT00071058|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|60 months, 19 days||||Participants|||Number
1296293|NCT00071058|Primary|Percentage of Participants With a Partial or Complete Response|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all signs and symptoms of tumor for a period of at least 4 weeks. Partial response is defined as at least a 30% decrease in the sum of the longest diameter of all measured lesions lasting for a period of 4 weeks.|Every 6 weeks for up to a year||||Percentage of participants|||Number
1296294|NCT00003907|Secondary|Overall Survival|Overall survival was defined as time from registration to death from any causes.|Assessed every 3 months for 2 years, then every 6 months for 3 year.|all eligible and treated patients|||Months||90% Confidence Interval|Median
1296295|NCT00003907|Secondary|Tumor Response|Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.|Assessed every 6 weeks|all eligible and treated patients|||Proportion of participants||90% Confidence Interval|Number
1296296|NCT00003907|Primary|Time to Progression|Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions|Assessed every 3 months for 2 years, then every 6 months for 3 year.|All eligible and treated patients|||Months||90% Confidence Interval|Median
1296297|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
1296298|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years|Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
1296299|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HR-negative, HER2-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
1296300|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years|Patients with HR-negative, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
1296301|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HR-positive, HER-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
1296302|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years|Patients with HR-positive, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
1296303|NCT00070564|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated every 4 weeks while on protocol therapy.|Limited to patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.|||Participants|||Number
1296304|NCT00070564|Primary|Overall Survival|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Every 6 months for 5 years|Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.|||percentage of participants||95% Confidence Interval|Number
1296305|NCT00070564|Primary|Disease-free Survival|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|every 6 months (annually for mammograms) for 5 years|Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.|||percentage of participants||95% Confidence Interval|Number
1296306|NCT00070499|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.|Eligible patients who started therapy|||Participants with a given type of AE|||Number
1296307|NCT00070499|Secondary|Two Year Relapse-free Survival|Relapse-free survival is measured from the date of documented (possibly unconfirmed) hematologic complete remission until loss of hematologic complete remission or death from any cause. Observations are censored at the date of last contact for patients last known to be alive with report of loss of hematologic complete remission.|every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5|Eligible, treated patients who achieved a hematologic complete remission|||Percent of population|||Number
1296308|NCT00070499|Secondary|2-year Overall Survival (OS)|Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.|Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5|All eligible patients who were treated|||Percent of population|||Number
1296309|NCT00070499|Secondary|Hematologic Response|Hematologic response assesses whether patients' blood counts return to normal|1 month after starting treatment|Eligible, treated patients who were evaluable for hematologic response|||participants|||Number
1296310|NCT00070499|Primary|Molecular Response Rate at 12 Months|Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.|pretreatment and after 12 months of treatment|Patients with follow-up specimens assayed by reverse transcription polymerase chain reaction (RT-PCR)|||participants|||Number
1296311|NCT00070317|Primary|False Negative Predictive Value (FNPV)|The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases|At the time of Surgery|Eligible and evaluable patients who tested as negative sentinel node and have lymph node sampling|||Percentage of participants||90% Confidence Interval|Number
1296314|NCT00070291|Primary|Response Rate (Complete and Partial Response)|Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.|Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.|all 4 enrolled patients|||Proportion of participants||95% Confidence Interval|Number
1296315|NCT00070135|Secondary|Non-relapse Mortality (NRM)|Percentage of patients who died due to causes other than relapse|Up to 5 years||||percentage of patients|||Number
1296316|NCT00070135|Secondary|2 Year DFS for All Patients|Percentage of participants who were alive and relapse free at 2 years for all patients. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
1296317|NCT00070135|Primary|2 Year Disease Free Survival In Unrelated Donor Recipient Group|"Percentage of participants who were alive and relapse free at 2 years for patients who were matched with an unrelated donor for transplant. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.~A relapse is defined as any of the following:~Reappearance of leukemia blasts cells in peripheral blood~>5% blasts in the marrow, not attributable to another cause (e.g., bone marrow regeneration)~If there are no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow ≥ 1 week later with >5% blasts is necessary to meet the criteria for relapse~The development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid"|2 years|Participants who received a matched unrelated donor were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
1296318|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin clearance. Group 1 and group 2 patients were excluded due to not submitting specimens.|||L/hr||Standard Deviation|Mean
1296319|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin AUC. Group 1 and group 2 patients were excluded due to not submitting specimens.|||ng/(mLxh)||Standard Deviation|Mean
1296320|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin half life. Group 1 and group 2 patients were excluded due to not submitting specimens.|||hours||Standard Deviation|Mean
1296321|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate apparent volume at steady state of trabectedin of trabectedin. Group 1 and group 2 patients were excluded due to not submitting specimens.|||L||Standard Deviation|Mean
1296322|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate maximum plasma concentration of trabectedin. Group 1 and group 2 patients were excluded due to not submitting specimens.|||ng/mL||Standard Deviation|Mean
1296323|NCT00070109|Primary|Number of Patients With Dose-Limiting Toxicity (DLT)|Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of > 7 days duration or Grade 4 thrombocytopenia of > 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.|1 Cycle|Two pts in Group 1 and 1 pt in Group 2 were excluded because they were removed from therapy prior to the DLT evaluation period and no DLT had been observed. No patients in Groups 3, 4, or 5 were evaluated for DLT.|||participants|||Number
1296324|NCT00070109|Primary|Response (Complete Response [CR] and Partial Response [PR])|Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - >=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.|Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.|No pts in Group 1 were evaluated for response. 1 pt in Group 3 is excluded because the pt was removed from protocol therapy after cycle 3 when a cardiac evaluation was missed. The pt was removed prior to disease assessment on protocol therapy. 1 pt enrolled in Group 4 was excluded because patient was removed from therapy prior to chemotherapy.|||participants|||Number
1296325|NCT00070018|Primary|Progression-free Survival|Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter||||percentage of participants||95% Confidence Interval|Number
1296326|NCT00069953|Secondary|Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection||Analysis occurs with the primary outcome measure.|||||||
1296327|NCT00069953|Secondary|Frequency of Major (Grade 4) Acute Treatment-related Toxicities||From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).|||||||
1296328|NCT00069953|Primary|Overall Survival (1-year Rate Reported)|One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1296329|NCT00069784|Other Pre-specified|Number of Patients With First Occurrence of Any Type of Cancer|Data on cancers that occurred in association with hospitalizations were collected systematically in both groups from the start of the study. All reported cancers occurring during the trial (new or recurrent) were adjudicated by the Event Adjudication Committee.|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|The analysis was based on the intent-to-treat (ITT) population.|||participants|||Number
1296330|NCT00069784|Other Pre-specified|Number of Patients With Various Types of Symptomatic Hypoglycemia Events|"Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia, based on data recorded in the participant’s diary. These were further categorized as confirmed (ie, with a concomitant home glucose reading ≤54 mg/dL [≤3.0 mmol/L]) or unconfirmed.~Severe hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following:~the event was associated with a documented self-measured or laboratory plasma glucose level ≤36 mg/dL (≤2.0 mmol/L), or~the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration."|on-treatment period (median duration of follow-up: 6.2 years)|The population analyzed was the safety population consisting of all randomized and treated patients (who received at least one dose of study drug) for the insulin glargine group and of all randomized patients for the standard care group.|||participants|||Number
1296331|NCT00069784|Secondary|Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG|The incidence was determined by calculating the proportion of randomized participants without diabetes at randomization who either developed diabetes during the study or who were classified as having possible diabetes based on results of two oral glucose tolerance tests (OGTT) performed after the last follow-up visit (within 21-28 days for OGTT#1 and within 10-14 weeks for OGTT#2).|from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years)|The analysis was based on the subgroup of the intent-to-treat (ITT) population without diabetes at randomization.|||percentage of patients|||Number
1296332|NCT00069784|Secondary|Composite Diabetic Microvascular Outcome (Kidney or Eye Disease)|"The composite outcome used to analyze microvascular disease progression contained components of clinical events:~the occurrence of laser surgery or vitrectomy for diabetic retinopathy (DR);~the development of blindness due to DR;~the occurrence of renal death or renal replacement therapy; as well as the following laboratory-based events:~doubling of serum creatinine; or~progression of albuminuria (from none to microalbuminuria [at least 30 mg/g creatinine], to macroalbuminuria [at least 300 mg/g creatinine])."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."|||participants|||Number
1296333|NCT00069784|Secondary|Total Mortality (All Causes)|Number of deaths due to any cause|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|The analysis was based on the intent-to-treat (ITT) population, which was all randomized participants, regardless of compliance with the protocol.|||participants|||Number
1297055|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 56|Percentage of participants with Viral Load < 400 copies/mL|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1296334|NCT00069784|Primary|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)|"Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease).~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."|||participants|||Number
1296335|NCT00069784|Primary|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke|"Number of participants with a first occurrence of one of the above events.~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."|||participants|||Number
1296336|NCT00069823|Secondary|Change in Number of Gastric Symptoms: No. of Symptoms|Mean change|Baseline to 24 Weeks||||symptoms||95% Confidence Interval|Mean
1296337|NCT00069823|Secondary|Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score|Mean change. The Gastroesophageal Reflux Disease Symptom Assessment Scale score ranges from 0 to 3, with lower numbers indicating less distress.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
1296338|NCT00069823|Secondary|Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component|Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
1296339|NCT00069823|Secondary|Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component|Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
1296340|NCT00069823|Secondary|Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)|Mean change. Scores on the Mini-Asthma Quality of Life Questionnaire (mini-AQLQ)range from 1 to 7, with higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
1296341|NCT00069823|Secondary|Change in Asthma Symptom Utility Index (ASUI)|Mean change. Scores on the ASUI range from 0 to 1, with higher scores indicating less severe asthma.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
1296342|NCT00069823|Secondary|Change in Juniper Asthma Control Score(JACQ)|Mean change. Scores on the JACQ range from 0 to 6, with lower scores indicating better asthma control and 0.5 as the minimal clinically important difference.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
1296343|NCT00069823|Secondary|Pulmonary Function: Change in PC20|Mean Change in the dose of methacholine that results in a 20% drop in FEV1|Baseline to 24 Weeks||||mg/ml||95% Confidence Interval|Mean
1296344|NCT00069823|Secondary|Pulmonary Function: Change in Peak Flow Rate|Mean change from baseline to 24 weeks in the peak flow rate - how forceful patient can blow out air|Baseline to 24 Weeks||||liters/min||95% Confidence Interval|Mean
1296345|NCT00069823|Secondary|Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity|Pulmonary function measured by mean change in Prebronchodilator forced vital capacity from baseline to 24 weeks|Baseline to 24 Weeks||||liters||95% Confidence Interval|Mean
1296346|NCT00069823|Secondary|Pulmonary Function: Change in Prebronchodilator FEV1|Mean change in pre-bronchodilator FEV1 - forced expiratory volume in 1 second; a measure of pulmonary function. The treatment effect is the difference in the mean change in between the groups.|Baseline to 24 Weeks|The analyses are based on data from 191 participants in the placebo group and 201 in the esomeprazole group, with the following exception: 41 participants in the placebo group and 37 in the esomeprazole group for measurement of 20% post-diluent baseline (PC20).|||liters||95% Confidence Interval|Mean
1296347|NCT00069823|Secondary|Night Awakening|Rate of awakening at night because of asthma symptoms|Baseline to 24 Weeks||||events per person-year|||Number
1296348|NCT00069823|Secondary|Use of Rescue Medications|Increase in the use of rescue meds by 4 or more uses on a particular day above the average uses during the run-in period.|Baseline to 24 Weeks||||events per person-year|||Number
1296349|NCT00069823|Secondary|Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists||Baseline to 24 Weeks||||events per person-year|||Number
1296350|NCT00069823|Secondary|Exacerbation Components: New Use of Oral Corticosteroids||Baseline to 24 Weeks||||events per person year|||Number
1296351|NCT00069823|Primary|Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion|Episodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow >=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma|Baseline to 24 Weeks||||events per person year|||Number
1296354|NCT00069641|Secondary|Percent Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 53|Cardiac LVMI was determined by echocardiography. Change was calculated at Week 53 from baseline. LVMI is the LVM, in grams indexed to BSA, in square meter [m^2]. LVMI in g/m^2 = LVM divided by BSA.|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||percent change||Standard Error|Mean
1296355|NCT00069641|Secondary|Mean Cardiac Left Ventricular Mass Index (LVMI) at Baseline|Cardiac LVMI was determined by echocardiography. LVMI is the left ventricular mass (LVM, in grams [g]) indexed to body surface area (BSA), in square meter [m^2]. LVMI (in gram per square meter [g/m^2]) = LVM divided by BSA.|Baseline|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||gram per square meter (g/m^2)||Standard Error|Mean
1296356|NCT00069641|Primary|Ranked Adjusted 2-Component Composite Variable Score Based on Change From Baseline to Week 53|The 2-component composite variable consists of the sum of the ranked changes from baseline to Week 53 for percent predicted Forced Vital Capacity (FVC) and 6-Minute Walking Test (6MWT) total distance walked. For the 2 treatment groups being compared, ranking occurred within the comparison treatment groups combined (idursulfase weekly and placebo treatment groups). These comparison groups were pooled and ranked for each component separately. Within each component (% predicted FVC, 6MWT), the change from baseline was then ranked. The lowest change value was assigned a rank of 1, the next lowest a rank of 2, etc. The composite score for each participant was the sum of the 2 ranked scores corresponding to the 2 individual components (% predicted FVC and 6MWT) for each participant. Thus, the greater the composite score (greater the sum of the ranks of the changes from baseline, where the lowest change was ranked as 1), the greater the improvement.|Baseline, Week 53|Intent-to-treat (ITT) population, Only participants receiving “Idursulfase Weekly” or “Placebo” were to be analyzed for this outcome.|||sum of the ranked scores||Standard Error|Mean
1296357|NCT00069641|Secondary|Change From Baseline in Mean Normalized Urine Glycosaminoglycan (GAG) Levels at Week 53|Mean normalized urine GAG was analyzed using urine testing. Change was calculated at Week 53 from baseline. The urine GAG levels were normalized to urine creatinine and were reported as microgram GAG per milligram creatinine (mcg GAG/mg creatinine).|Baseline, Week 53|ITT population.|||mcg GAG/mg creatinine||Standard Error|Mean
1296358|NCT00069641|Secondary|Percent Change From Baseline in Mean Combined Liver and Spleen Volume at Week 53|Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI). Change was calculated at Week 53 from baseline.|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||percent change||Standard Error|Mean
1296359|NCT00069641|Secondary|Mean Combined Liver and Spleen Volume at Baseline|Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI).|Baseline|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||milliliter (mL)||Standard Error|Mean
1296360|NCT00069641|Secondary|Change From Baseline in Mean Global Joint Range of Motion (JROM) Score at Week 53|Change was calculated at Week 53 from baseline. Global JROM (% of normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension [Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||percentage of normal range of motion||Standard Error|Mean
1296361|NCT00069277|Primary|Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.||12 Weeks||||participants|||Number
1296362|NCT00069264|Primary|Determination of the Maximum Tolerated Dose||28 Days||||mg/m^2|||Number
1296363|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||mm/hour||Standard Deviation|Mean
1296364|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mm/hour||Standard Deviation|Mean
1296365|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mm/hour||Standard Deviation|Mean
1296366|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||mg/dl||Standard Deviation|Mean
1296524|NCT00066781|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due > to any cause. The distribution of survival time will be estimated using > the method of Kaplan-Meier . Overall survival will be calculated for > all evaluable patients combined and by group (ie. for patients with or > without the UGT1A1*28 polymorphism).|Up to 2 years||||Months||95% Confidence Interval|Median
1296367|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mg/dl||Standard Deviation|Mean
1296368|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mg/dl||Standard Deviation|Mean
1296369|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||mg/liter||Standard Deviation|Mean
1296370|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mg/liter||Standard Deviation|Mean
1296371|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mg/liter||Standard Deviation|Mean
1296372|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||units on a scale||Standard Deviation|Mean
1296373|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
1296374|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
1296375|NCT00069329|Primary|Parent /Patient Pain Rating|Visual Analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||units on a scale||Standard Deviation|Mean
1296376|NCT00069329|Primary|Parent /Patient Pain Rating|Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
1296377|NCT00069329|Primary|Parent /Patient Pain Rating|Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
1296388|NCT00069121|Secondary|Overall Survival [Time to Event]|Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.|Intent-to-Treat Population|||months||95% Confidence Interval|Median
1296378|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||units on a scale||Standard Deviation|Mean
1296379|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
1296380|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
1296381|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||units on a scale||Standard Deviation|Mean
1296382|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
1296383|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
1296384|NCT00069238|Secondary|Clinical Response|Response was measured by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (Cru)is as per complete remission criterion except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response (PR) is ≥50% decrease in the SPD of 6 largest dominant nodes or nodal masses. Progressive disease (PD) is ≥50% increase from the nadir in the SPD of any previously identified abnormal node for PRS or non-responders. Stable disease (SD) is less than a PR but not progressive disease.|For patients with response:Restage sites of disease every (q) 3 months for the first year, then q4 months for the second year, and then q6 months for the next 3 years, and yearly thereafter. The timing for these visits may be adjusted + 2 months.||||Participants|||Count of Participants
1296385|NCT00069238|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|67 months and 9 days||||Participants|||Count of Participants
1296386|NCT00069238|Primary|Maximum Tolerated Dose (MTD) of Alemtuzumab|MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously every 3 weeks for up to 6 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT).|Evaluation of dose limiting toxicity was done at the end of each cycle or every 21 days.||||mg|||Number
1296387|NCT00069121|Secondary|Number of Participants Assesed for Adverse Events|"Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline.~See Adverse Events module for details."|followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake|Safety Population|||participants|||Number
1296389|NCT00069121|Secondary|Overall Survival [Number of Events]|Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.|Intent-to-Treat Population|||participants|||Number
1296390|NCT00069121|Secondary|Relapse-free Survival (RFS) [Time to Event]|Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.|Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.|Intent-to-Treat Population|||months||95% Confidence Interval|Median
1296391|NCT00069121|Primary|Disease-free Survival [Time to Event]|Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.|Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.|Intent-to-Treat Population|||months||95% Confidence Interval|Median
1296392|NCT00069121|Secondary|Relapse-free Survival (RFS) [Number of Events]|Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer.|Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.|Intent-to-Treat Population|||participants|||Number
1296393|NCT00069121|Primary|Disease-free Survival (DFS) [Number of Events]|Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.|Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.|Intent-to-Treat Population|||participants|||Number
1296394|NCT00069108|Secondary|Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment|Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.|Up to 3 years|All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters|||participants|||Number
1296395|NCT00069108|Secondary|Time To Treatment Failure|Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.|Up to 3 years|All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters.|||days||95% Confidence Interval|Median
1296396|NCT00069108|Secondary|Duration Of Response|Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented. CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the Intent-to-treat (ITT) population. Participants in this population were analyzed according to the arm to which they were randomized.|||days||95% Confidence Interval|Median
1296397|NCT00069108|Secondary|Time To Response|Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met. CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level. PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.|||participants|||Number
1296398|NCT00069108|Secondary|Overall Survival|Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.|||days||95% Confidence Interval|Median
1296399|NCT00069108|Secondary|Best Overall Response, Independent Review Committee Assessment|Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD. CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. This PFS evaluation was based on Independent Review Committee Assessment.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.|||participants|||Number
1296400|NCT00069108|Secondary|Best Overall Response, Investigators’ Assessments|Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks. For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.|||participants|||Number
1296401|NCT00069108|Secondary|Progression Free Survival Based on Treatment Analysis- Per Population|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization|Up to 3 years|The PP population included randomized participants who received at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.|||days||95% Confidence Interval|Median
1296402|NCT00069108|Secondary|Progression Free Survival Based on Treatment Analysis- Intent To Treat Population|Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the Intent To Treat (ITT) population. Participants were analyzed according to the arm to which they were randomized.|||days||95% Confidence Interval|Median
1296403|NCT00069108|Secondary|Progression Free Survival Based on Independent Review Committee Assessment|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. This PFS evaluation was based on Independent Review Committee Assessment.|Up to 3 years|PP population excluded randomized participants who did not receive at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who had a major violation of protocol inclusion or exclusion criteria.|||days||95% Confidence Interval|Median
1296404|NCT00069108|Primary|Progression Free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization|Up to 3 years|The per protocol (PP) population included randomized participants who received at least one dose of capecitabine, 5-FU, or oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.|||days||95% Confidence Interval|Median
1296405|NCT00069095|Secondary|Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
1296406|NCT00069095|Secondary|Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296568|NCT00065806|Secondary|Change in Natural Log of mg/L for hsCRP||Change from baseline to 36 months||||natural log of mg/L||95% Confidence Interval|Mean
1296407|NCT00069095|Secondary|Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
1296408|NCT00069095|Secondary|Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296409|NCT00069095|Secondary|Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Week 1 to Week 54|The ITT population included all randomized participants who provided written informed consent.|||Participants|||Number
1296410|NCT00069095|Secondary|Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Week 1 to Week 54|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||Participants|||Number
1296411|NCT00069095|Secondary|Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296412|NCT00069095|Secondary|Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296413|NCT00069095|Secondary|BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||Percentage of responders|||Number
1296414|NCT00069095|Secondary|BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||Percentage of responders|||Number
1296415|NCT00069095|Secondary|Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||Percentage of responders|||Number
1296416|NCT00069095|Secondary|Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4|According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||Percentage of responders|||Number
1296417|NCT00069095|Primary|PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
1296418|NCT00069095|Secondary|Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
1296419|NCT00069095|Secondary|Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296420|NCT00069095|Secondary|PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
1296506|NCT00068107|Primary|Estimated Glomerular Filtration Rate (eGFR)|The rate of decline in renal function, as measured by estimation of glomerular filtration rate at baseline when participants were receiving agalsidase alfa (Relagal) every 2 weeks and when participants were receiving weekly infusion of Relagal.|Relagal was administered every 2 weeks for 2-4 years pre-study, Relagal was administred weekly during the study (approx. 4.5-10 years)||||ml/min/month||Standard Deviation|Mean
1296421|NCT00069095|Secondary|PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296422|NCT00069095|Secondary|PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
1296423|NCT00069095|Secondary|PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296424|NCT00069095|Secondary|PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
1296425|NCT00069095|Secondary|PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296437|NCT00068770|Primary|Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib|subjects will take one dose of celecoxib and will then have 6 hours of blood draws, day 2 subject will take 2 doses of celecoxib 8 hours apart with 2 additional blood samples, one hour apart. Subject, will continue to take 2 doses of celecoxib for 6 weeks, with a sample (PK) drawn every week prior to the first dose of the week. Comparison of Cmax of Celecoxib is reported|First dose of celecoxib through completion of radiation, 6 weeks.|"pts who had PK data for the first dose of celecoxib. observations were excluded if sample was not collected within 12 +/- 2h after taking prior dose, was drawn after dosing on same day or determine to be outlier by dixon's test.~PK data was available for 15 pts in the +EIASD group and 12 pts in the -EIASD group"|||(ng/ml)||Standard Deviation|Geometric Mean
1296438|NCT00068718|Secondary|Progression-free Survival|Percentage of patients with progression-free survival|1 year after DLI||||percentage of participants|||Number
1296439|NCT00068718|Secondary|Overall Survival|Percentage patients surviving 1 year post-transplant.|1 year after DLI||||percentage of participants|||Number
1296426|NCT00069095|Primary|Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4|PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.|Baseline until disease progression or death, approximately 2 years 6 months|The eligible patient population (EPP) excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
1296427|NCT00069160|Secondary|Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue|99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001.|3-24 hours||||Percent||Full Range|Median
1296428|NCT00069160|Secondary|Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar|A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan.|3 - 24 hours|Percent increase in sestamibi AUC in liver after tariquidar.|||percent increase in sestamibi AUC||Full Range|Median
1296429|NCT00069160|Primary|Clinical Response Rate|Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/- 20 mm with conventional techniques (CT, MRI, xray) or as >/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter <20 mm with conventional techniques or <10 mm using spiral CT.|4 years, 8-11 months||||Percentage of participants|||Number
1296430|NCT00069160|Primary|Geometric Mean of Area Under Curve (AUC0)-24||24 hours|Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Pharmacokinetic data were evaluable in 39 patients. Paired data from 31 participants were evaluable.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1296431|NCT00069160|Primary|The Number of Participants With Adverse Events.|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|4 yrs 8-11 months||||participants|||Number
1296432|NCT00069160|Primary|Geometric Mean of Maximum Concentration of the Drug (Cmax)|In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared.|24 hours|Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Data were evaluable in 39 patients. Paired data from 31 participants were evaluable.|||Cmax (ng/mL)||95% Confidence Interval|Geometric Mean
1296433|NCT00068822|Primary|Patient's Rating of Average Pain at 1 Month|Patient's rating of average pain intensity during the preceding 24 hours at 1 month. The rating scale was from 0 to 10, with higher scores indicating more severe pain.|1 month|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.|||units on a scale||Standard Deviation|Mean
1296434|NCT00068822|Secondary|Patient Well-being at 1 Month|"Patient well-being was quantified by these tools: Health status outcome using Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).~Pain Frequency Index, Pain Bothersome Index (scores range from 0-4, higher scores indicating more severe pain).~European Quality of Life (QOL) 5 Dimensions (EQ-5D), scale range -0.1 to 1.0; higher scores indicating a better QOL.~Study of Osteoporotic Fractures-Activities of Daily Living (SOF ADL6) range from 0 to 18; higher scores = more back-related disability."|Month 1|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.|||units on a scale||Standard Deviation|Mean
1296435|NCT00068822|Primary|Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month|Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.|1 month after procedure|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.|||units on a scale||Standard Deviation|Mean
1296436|NCT00068770|Secondary|Overall Survival|duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme|date pt started treatment to date pt last known alive|latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group|||months||95% Confidence Interval|Mean
1296442|NCT00068718|Secondary|Incidence of Relapse/Progression|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~CMML, AML, ALL >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.~CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter’s transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|1 year after DLI||||percentage of participants|||Number
1296443|NCT00068718|Secondary|Incidence of Graft Rejection|Percentage patients with graft rejection.|100 days after DLI||||percentage of participants|||Number
1296444|NCT00068718|Primary|Safety of DLI Following a Non-myeloablative Transplant, Defined as Incidence of Grade IV Acute GVHD|Percentage of Participants with Grade IV Acute GVHD|100 days after DLI||||percentage of participants|||Number
1296445|NCT00068692|Secondary|Failure Pattern|Type of failures (local/regional recurrence vs. distant recurrence vs. concurrent recurrence vs. second primary cancer vs. deaths) in the analysis population|assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years|All randomized patients|||Participants|||Count of Participants
1296446|NCT00068692|Secondary|Proportion of Sphincter Preservation|Proportion of sphincter preservation was defined as number of patients with sphincter preservation divided by total number of patients randomized to the arm|assessed at primary surgery time|All randomized patients|||proportion of patients||95% Confidence Interval|Number
1296447|NCT00068692|Secondary|3-year Disease Free Survival|Disease free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer and death from any cause, whichever occurred first. 3-year DFS rate was estimated using Kaplan-Meier method.|assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years|All randomized patients|||proportion of patients||95% Confidence Interval|Number
1296448|NCT00068692|Primary|3-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.|assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years|All randomized patients|||proportion of patients||95% Confidence Interval|Number
1296449|NCT00068601|Secondary|Rate of Ovarian Dysfunction at 1 Year|Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.|1 year|Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 1|||Participants|||Count of Participants
1296450|NCT00068601|Other Pre-specified|Ovarian Reserve at 1 and 2 Years|"Measurements of ovarian reserve will consist of Day 2 - 4 levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25)."|1 and 2 years|||||||
1296451|NCT00068601|Secondary|Rate of Ovarian Dysfunction at 2 Years|Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.|2 years|Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 2|||Participants|||Count of Participants
1296452|NCT00068601|Primary|Rate of Premature Ovarian Failure at 2 Years|Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.|2 years|Patients who completed the study|||Participants|||Count of Participants
1296453|NCT00068588|Primary|Response Rate of a Combination of GTI-2040 and Capecitabine|Following the dose escalation step, additional patients will be accrued at the MTD and evaluated for disease response using RECIST v1.0 criteria. Patients with confirmed complete or partial response are considered to have responded favorably to treatment.The sample size and early stopping for futility was governed by a two stage Optimum design suggested by Simon. It was assumed that a true response rate less than 25% would not warrant further study of this agent. It was also assumed that a response rate of 45% would be considered promising. In the first stage (following the dose escalation step), 15 evaluable patients were treated. Four or fewer observed responses, would stop accrual, while 5 or more observed would continue accrual for an additional 12 patients during the second stage of the study. Ten or more responses out of 27 patients will be considered evidence warranting further study of the regimen providing toxicity and survival also appear favorable.|Up to 6 years|Response Rate was only assessed at the determined MTD. Additional patients were accrued to determine treatment efficacy at the MTD.|||percentage of patients responding|||Number
1296454|NCT00068588|Primary|Maximum Tolerated Dose Determined by Dose-limiting Toxicities|1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0|21 days||||Patients experiencing DLT|||Number
1296455|NCT00068575|Primary|Median Overall Survival (OS)|Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.|Participants followed till disease progression or death (approximately 6 years)|Analysis by protocol.|||months||95% Confidence Interval|Median
1296456|NCT00068445|Secondary|Change in POMS Total Score [Week 10 Minus Baseline]|The average change in POMS Total scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The POMS scales are calculated from patient responses on 30 questions asking how they have been feeling during the past week. The scores are all transformed so that 0 is the worst possible value and 100 is the best possible value.|From baseline to week 10|Participants with POMS scales data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
1296457|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Pain Interference scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Pain Interference data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
1296458|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Pain Relief scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Pain Relief data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
1296459|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Pain Now scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Pain Now data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
1296460|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Average Pain data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
1296461|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]|"The average change in Brief Pain Inventory (BPI) Least Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.~Time Frame:~Up to 1 week post-treatment"|From baseline to week 10|Participants with BPI Least Pain data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
1296462|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Worst Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Worst Pain data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
1296463|NCT00068445|Secondary|The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10|The change in overall quality of life as measured by the Uniscale QOL (Week 10 minus Baseline) using the Wilcoxon test is reported for each arm below. The Uniscale is a score that ranges from 0 to 100, with 0 being QOL as bad as it can be and 100 being as good as it can be.|From baseline to week 10|Participants with Uniscale QOL data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
1296464|NCT00068445|Primary|Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)|The change in mean score for average daily pain from baseline to week 10 using the European Cooperative Oncology Group (ECOG) neuropathy scale (ENS) are reported below. The ENS scale goes from 0 to 3 with 0=none, 1=mild paresthesias, 2=mild or moderate sensory loss and/or moderate paresthesias, and 3=severe sensory loss or paresthesias that interfere with function.|From baseline to week 10||||units on a scale||Standard Deviation|Mean
1296465|NCT00068445|Primary|Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)|The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below. The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.|From baseline to week 10||||units on a scale||Standard Deviation|Mean
1296466|NCT00068419|Secondary|Changes in Magnetic Resonance Imaging (MRI) Signal Features|MRI must include images in at least two planes with (a) pre-contrast images with the following pulse sequences T-1 weighted, fast spin echo T-2 weighted with fat saturation, and a short tau inversion recovery (STIR); and (b) post-contrast images with T-1 weighted pulse sequence with fat suppression.|From baseline to up to 5 years|||||||
1296467|NCT00068419|Secondary|Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)||Up to 5 years|||||||
1296468|NCT00068419|Secondary|Toxicity as Assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0||Up to 12 months|||||||
1296469|NCT00068419|Primary|Event-free Survival|Two-year event-free survival (EFS). Events include disease progression (increase in the greatest product of 2 perpendicular diameters of any lesion by > 25% or new biopsy-proven lesions), and death in absence of disease progression. Reported as Kaplan-Meier estimate of two-year EFS proportion.|Study enrollment until time of disease progression or death as a first event (maximum follow-up 5 years)|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1296470|NCT00068406|Primary|Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period|Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0|Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment|Eligible and treated patients|||Participants|||Count of Participants
1296471|NCT00068406|Primary|Complete Clinical and Pathologic Response|Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.|Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.|Eligible and treated patients|||Percentage of Participants||90% Confidence Interval|Number
1296472|NCT00068393|Secondary|Progression-free Survival|Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.|||Months||95% Confidence Interval|Median
1296473|NCT00068393|Secondary|Overall Survival|Overall survival is defined as the time from study entry until death from any cause.|Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.|||Months||95% Confidence Interval|Median
1296474|NCT00068393|Primary|Response Rate by Solid Tumor Response Criteria (RECIST)|Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.|||Percentage of Participants||90% Confidence Interval|Number
1296475|NCT00068380|Primary|Baseline Gene Expression Levels of the Target Genes (PDGF-R and PDGF), Genes Associated With Induction of Apoptosis (Bcl-2, Bax), and Cell Cycle Regulatory Genes (p53, p21, p27|Will summarized overall and according to response and toxicity (if numbers permit), using medians, quartiles and ranges – or if a transformation is found to render the data compatible with the normal assumptions, with means, standard deviations, and confidence intervals. The association with progression-free survival or overall survival will be assessed by dichotomizing the measures of gene expression at the median (or by previously established cut-points) and constructing Kaplan-Meier plots.|Baseline|Gene data were not collected. Due to budget constraints and recent reprioritizations, CTEP closed the study to accrual prior to collection of correlative data.||||||
1296476|NCT00068380|Primary|Time to Treatment Failure|Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From first day of treatment until discontinuation of treatment, assessed up to 30 days post treatment||||Months||95% Confidence Interval|Median
1296477|NCT00068380|Primary|Overall Survival|Will be summarized using the Kaplan-Meier product-limit estimators.|From first day of treatment to time of death due to any cause, assessed up to 5 years post-treatment||||Months||95% Confidence Interval|Median
1296478|NCT00068380|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 30 days post treatment||||Months||95% Confidence Interval|Median
1296479|NCT00068380|Primary|Toxicity Summary|Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.|Up to 30 days post treatment||||Participants|||Count of Participants
1296480|NCT00068380|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by X-Ray, MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 years||||percentage of patients responding|||Number
1296481|NCT00068367|Other Pre-specified|Feasibility of Accruing These Patients in the Cooperative Group Setting|NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY||||||||
1296482|NCT00068367|Other Pre-specified|Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug.|NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY||||||||
1296483|NCT00068367|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 25 weeks|All participants receiving at least some protocol treatment|||Participants|||Number
1296484|NCT00068367|Primary|Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.|"Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values.~Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions."|25 weeks||||Participants|||Count of Participants
1296485|NCT00068341|Secondary|Pathologic Nodal Status|According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1–3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4–9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer|5 years|only 71 subjects of the 74 subjects could be analyzed for this outcome measure due to data collection error.|||participants|||Number
1297025|NCT00055471|Secondary|Total Prostate Specific Antigen (PSA) Concentration|Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).|Baseline to Day 15.|All dosed patients.|||ng/ml||Full Range|Geometric Mean
1296489|NCT00068341|Primary|Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.|"Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR).~Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen."|5 years|pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]|||participants|||Number
1296490|NCT00068250|Secondary|Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)|Progression is defined as greater than 25% increase in enhancing tumor or the appearance of new lesions in the brain, eye, or the appearance of a new positive cerebrospinal fluid (CSF) cytology. The patient may be neurologically stable or worse and on stable or increasing doses of corticosteroid. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )|Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.|Eligible patients on Temozolomide 100 mg arms who started study treatment|||years||95% Confidence Interval|Median
1296491|NCT00068250|Secondary|Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)|Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )|From start of treatment to 10 weeks if RT received, to 15 weeks if not.|Eligible patients on Temozolomide 100 mg arms who started study treatment and have scans for central review|||Participants|||Count of Participants
1296492|NCT00068250|Primary|Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)|Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )|Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.|Eligible patients on Temozolomide 100 mg arms who started study treatment|||percentage of participants||95% Confidence Interval|Number
1296493|NCT00068250|Primary|Number of Phase I Participants Experiencing Toxicity|A dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematological toxicity (other than grade 3 nausea/vomiting) or any hematological toxicity resulting in the discontinuation of temozolomide. Toxicity evaluation for this dose escalation includes all toxicities occurring prior to the start of radiation therapy. If the patient did not receive radiation therapy, then toxicity evaluation included all toxicities occurring through week 15. Any grade 5 toxicity would result in immediate suspension of accrual.|From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not.|Eligible patients on Phase I arms who started study treatment|||Participants|||Count of Participants
1296494|NCT00068237|Secondary|Overall Survival||From registration to date of death or last follow-up|||||||
1296495|NCT00068237|Secondary|Disease-free Survival||From registration to date of failure (local or regional persistence/relapse or distant metastasis or second primary tumor or death) or last follow-up|||||||
1296496|NCT00068237|Secondary|Toxicity||From start of treatment to last follow-up|||||||
1296497|NCT00068237|Secondary|Quality of Life||From registration to 1 year|||||||
1296498|NCT00068237|Secondary|Salivary Scan Evaluation||From start of treatment to 6 months|||||||
1296499|NCT00068237|Secondary|Rate of Acute Xerostomia||From start of treatment to 90 days|||||||
1296500|NCT00068237|Primary|"Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed Per Protocol"|"Surgery will be scored as per protocol prescription if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery per protocol prescription, then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%."|At the time of the submandibular salivary gland transfer|Eligible patients who started study treatment.|||participants|||Number
1296501|NCT00068107|Secondary|Doppler Skin Blood Flow||10 years|Doppler skin blood flow was not collected in this study because it was judged to not be useful early in the study.||||||
1296502|NCT00068107|Secondary|Quantitative Sensory Testing|For quantitative sensory testing, the outcome variable (detection threshold score) was analyzed for all combinations of location (foot, hand, and thigh) and test (cold, vibration, and warm). Possible threshold scores may range from 1-25. Score values of “>25” were set to 25. Higher scores indicate higher sensory detection threshold. Therefore, lower score is better. Time, measured in years, was centered at the date in which patients switched treatment regimen. All available measurements were used. A linear mixed model analysis was used to test for differences in the linear association between time and detection threshold score pre-and-post ERT regiment change while accounting for the correlation among observations from the same individual. Specifically, the model contained a subject specific random intercept with year as a fixed effect and knot at time of the treatment change.|pre-study was 2-4 years, during study sensory testing measured for approx. 4.5-5 years|Number of participants with a sufficient number of data points to estimate slope|||units on a scale/year||Standard Error|Mean
1296507|NCT00067990|Secondary|Number of Participants With Cortical Interstitial Volume Expansion or Any ESRD|Number of subjects who had doubling of the interstitial or any end stage renal disease (ESRD) not attributed to interstitial fibrosis and tubular atrophy (IF/TA)|Baseline and 5 Years Post Transplant|Number of subjects who had baseline and exit biopsy samples that could be analyzed for doubling of cortical interstitial volume expansion or graft loss from IF/TA.|||Participants|||Count of Participants
1296508|NCT00067990|Primary|Doubling of Interstitium or Any ESRD|Doubling of the interstitial or any defined ESRD (including IF/TA)|Baseline to 5 years||||Participants|||Count of Participants
1296509|NCT00067808|Primary|Participant Responses|Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to >100 x 109/L; and 'No Response'.|Response to treatment after 8 weeks of therapy|As treated: 124 patients completed treatment.|||Participants|||Number
1296510|NCT00067470|Secondary|Change From Baseline in Urinary GAG (uGAG) at 24 Weeks|Glycosaminoglycan (GAG) level measured in urine|baseline and 24 weeks|Baseline uGAG level was measured for 19 rhASB-treated subjects and 20 placebo-treated subjects. However, uGAG levels at 24 weeks were measured for 19 rhASB-treated subjects and 19 placebo-treated subjects, because 1 placebo-treated subject withdrew from the study before week 24.|||micrograms per mg creatinine||Standard Deviation|Mean
1296511|NCT00067470|Secondary|Change From Baseline in 3-minute Stair Climb at 24 Weeks|Number of stairs climbed per minute in 3 minutes at 24 weeks minus number of stairs climbed per minute in 3 minutes at baseline|baseline and 24 weeks|The efficacy analysis included all subjects except one from the placbo group who withdrew from the study prior to the week 24 assessment.|||stairs/min||Standard Deviation|Mean
1296512|NCT00067470|Primary|Change From Baseline in 12-minute Walk Test at 24 Weeks|Number of meters walked in 12 minutes at week 24 minus number of meters walked in 12 minutes at baseline|baseline and 24 weeks|The efficacy analysis included all subjects except one from the placebo group who withdrew from the study prior to the week 24 assessment.|||meters||Standard Deviation|Mean
1296513|NCT00067236|Primary|Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)|Mean change of left ventricular end diastolic volume index (mL/m2) as evaluated via ventricular end-diastolic volume index augmentation 90 days post Myocardial Infarction (MI)|90 days|A patient was considered evaluable for the primary efficacy assessment if data were complete for at least the baseline and Day 90 visit (i.e., no data were imputed for the primary endpoint).|||mL/m2||Standard Error|Mean
1296514|NCT00066963|Primary|Number of Caries Incident Cases|A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.|two years|intention-to-treat with any follow-up information. multiple imputation for sensitivity analyses.|||participants|||Number
1296515|NCT00066937|Secondary|Mental Health as Assessed by the Short Form 36 Healthy Survey|The Mental Health Component score from the Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health. The mental health component score is calculated from responses to the general health, mental health, vitality, physical and emotional role limitations, and social functioning subscales, with higher scores indicating better mental health. The scale ranges from zero (equivalent to maximum disability) to 100 (no disability).|baseline, post-treatment, 3 months, 6 months||||units on a scale||Standard Deviation|Mean
1296516|NCT00066937|Secondary|Worst Pain|0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week|baseline, post-treatment, 3 months, 6 months||||units on a scale||Standard Deviation|Mean
1296517|NCT00066937|Primary|Change in Pain-related Interference|Multidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference|baseline, post-treatment, 3 months, 6 months||||Change in scores on a scale||Standard Deviation|Mean
1296518|NCT00066937|Primary|Average Pain|0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain|baseline, post-treatment, 3 months, 6 months||||units on a scale||Standard Deviation|Mean
1296519|NCT00066807|Secondary|Sites of First Treatment Failure||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.||||||
1296520|NCT00066807|Secondary|Systemic Disease-free Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.||||||
1296521|NCT00066807|Secondary|Overall Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.||||||
1296522|NCT00066807|Primary|Disease-free Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.||||||
1296523|NCT00066781|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Time to disease progression will be calculated for all evaluable patients combined and by group (ie. for patients with or without the UGT1A1*28 polymorphism).|Up to 2 years||||Months||95% Confidence Interval|Median
1297049|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load < 50 copies/mL|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1296525|NCT00066781|Primary|Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria|The primary endpoint is confirmed response rate. If measurable disease is present, a confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All registered patients meeting the eligibility criteria that have signed a consent form and have begun treatment will be evaluable for response.|Up to 2 years|All evaluable patients|||percentage of patients with response||95% Confidence Interval|Number
1296526|NCT00066742|Secondary|Progression-Free Survival|Progression was defined as a >= 20% increase in the sum of longest diameters of measurable lesions over the smallest sum observed or unequivocal progression of non-measurable disease or the appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring discontinuation of treatment. Progression-free survival was defined as the time from the date of enrollment until the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.|At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.||||months||95% Confidence Interval|Median
1296527|NCT00066742|Secondary|Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.|A complete response (CR) was defined as a complete disappearance of all disease with no new lesions. A partial response (PR) was defined as at least a 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. Both CR and PR had to be confirmed by a second determination at least 4 weeks apart. All disease had to be assessed using same method as baseline. Only patients with measurable disease at baseline were included in this analysis.|After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.|Only eligible patients who received protocol treatment were included in the analysis.|||participants|||Number
1296528|NCT00066742|Primary|Overall Survival|Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.|Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.|Only eligible patients who received protocol treatment were included in the analsysis.|||months||95% Confidence Interval|Median
1296529|NCT00066703|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates||2017-12-31|12/2017||||
1296530|NCT00066703|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up|5-year estimates reported at a median follow-up of 72 months|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
1296531|NCT00066703|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimate reported at a median follow-up of 72 months|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
1296532|NCT00066703|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.|5-year estimate reported at a median follow-up of 72 months|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
1296533|NCT00066690|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates||2017-06-30|06/2017||||
1296534|NCT00066690|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
1296535|NCT00066690|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
1296536|NCT00066690|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
1296537|NCT00066573|Secondary|Clinical Fracture Rate: Number of Participants With Bone Fractures.|Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.|8 years||||Participants|||Count of Participants
1296582|NCT00014560|Primary|Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|Day 1-29|||||||
1296538|NCT00066573|Secondary|Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence|Time to distant disease-free survival (DDFS) is defined as the time from randomization to the time of documented distant recurrence. Distant recurrence is the cancer coming back in a part of the body away from the breast, such as the bones or liver.|5 years|Intent to treat|||Participants|||Count of Participants
1296539|NCT00066573|Secondary|Overall Survival: Percentage of Participants Alive at 5 Years|Overall survival is defined as the time from randomization to the time of death from any cause.|5 years|Intend to treat|||Percentage of Participants||95% Confidence Interval|Number
1296540|NCT00066573|Primary|Event-free Survival|Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.|5 years||||percentage of participants||95% Confidence Interval|Number
1296541|NCT00066469|Primary|Event-free Survival|Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method.|2 years|One patient out of the 55 patients enrolled was ineligible for study and therefore was excluded from analysis.|||percentage of participants analyzed||95% Confidence Interval|Number
1296542|NCT00066365|Primary|Feasibility Success|Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs.|Enrollment through 21 days of protocol therapy|This outcome measure was calculated for eligible patients only. This yields 27 patients for assessment of this measure in Group 1 and 16 patients for assessment of this measure in Group 2.|||participants|||Number
1296543|NCT00066365|Primary|Event Free Survival (EFS)|EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact.|Time of enrollment to Event or 5 years from enrollment, whichever occurs first|There were 4 ineligible unilateral patients and 2 ineligible bilateral patients not included in this analysis.|||years||95% Confidence Interval|Median
1296544|NCT00066365|Primary|Clusterin Status in Post Chemotherapy Sample||29 days after start of protocol therapy|This outcome measure was evaluated in 30 patients, 20 patients in the unilateral recurrence group and 10 patients in bilateral recurrence group.|||participants|||Number
1296545|NCT00066365|Primary|Clusterin Status in Pre Chemotherapy Sample|The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were measured from the bilateral recurrence group.|||participants|||Number
1296546|NCT00066365|Primary|S100 Status in Post Chemotherapy Sample|"The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation."|29 days after start of protocol therapy|20 patients from the unilateral recurrence group and 10 patients from the bilateral recurrence group were evaluated for this outcome measure.|||participants|||Number
1296547|NCT00066365|Primary|S100 Status in Pre Chemotherapy Sample|"The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation."|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.|||participants|||Number
1296548|NCT00066365|Primary|CD1a Status in Post Chemotherapy Sample|CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.|29 days after start of protocol therapy|20 patients were evaluated for this outcome measure from the unilateral group and 7 patients were evaluated from the bilateral group.|||participants|||Number
1296549|NCT00066365|Primary|CD1a Status in Pre Chemotherapy Sample|CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.|||participants|||Number
1296550|NCT00066365|Primary|FAS Status in Post Chemotherapy Sample|FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.|||participants|||Number
1296551|NCT00066365|Primary|FAS Ligand in Post Chemotherapy Sample|FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.|||participants|||Number
1296552|NCT00066365|Primary|Presence of FAS in Pre-chemotherapy Sample|FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|Patients who were enrolled in Group 1 (unilateral recurrence) do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment.|||participants|||Number
1296595|NCT00065507|Secondary|Participants Achieving Prothrombin Time Normalization Through Week 48|Number of participants who achieved normalization of prothrombin time (<= 1 x ULN), a measure of liver function, at specific timepoints.|Baseline, Week4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.|||participants|||Number
1296553|NCT00066365|Primary|Status of FAS Ligand in Pre-chemotherapy Sample|FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|Patients who were enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 14 patients were evaluated for this primary outcome measure.|||participants|||Number
1296554|NCT00066222|Secondary|Tumor Response|Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|From the start of treatment to 2 months following the completion of chemotherapy|Eligible patients who started study treatment and were observed for at least 2 months post-treatment|||Participants|||Count of Participants
1296555|NCT00066222|Secondary|Frequency of Treatment-related Fatalities at 2 Years|A treatment-related fatality was any death judged to be related to protocol treatment.|From the start of treatment to 2 years|Eligible patients who started study treatment|||Participants|||Count of Participants
1296556|NCT00066222|Secondary|Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis|Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to toxicity.|From start of radiation therapy until 90 days following the start of radiation therapy|Eligible patients who started study treatment|||Participants|||Count of Participants
1296557|NCT00066222|Secondary|Median Overall Survival Time and Progression-free Survival Time|An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.|From registration to 2 years|All eligible patients who started study treatment|||months||95% Confidence Interval|Median
1296558|NCT00066222|Secondary|Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year|An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.|From registration to one year.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1296559|NCT00066222|Primary|Overall Survival at 2 Years|Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to 2 years|All eligible patients who started study treatment.|||percentage of participants||95% Confidence Interval|Number
1296560|NCT00066170|Primary|Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)|The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.|Baseline to Week 8||||Minutes||Standard Deviation|Mean
1296561|NCT00066066|Primary|Change in Mean Clinical Attachment Level.|Periodontal diseases are clinically diagnosed by assessments of gingival inflammation and measurements of tissue destruction. The damage to the apparatus of support of the teeth is quantified using measurements of probing pocket depth (PD) and clinical attachment level (CAL). These measurements are obtained using a periodontal probe which is introduced into the gingival sulcus to determine the distance in millimeters from the gingival margin to the depth of the sulcus or pocket (PD). Since the gingival margin fluctuates in response to inflammation (hyperplasia) or might recede, a more accurate measure of loss of attachment is obtained using the CAL, which measures the distance from a “fixed” landmark on the tooth such as the cemento-enamel junction to the depth of the pocket. Changes in CAL from baseline were used to assess results obtained with the treatment of periodontal diseases.|Baseline, 3, 6 and 12 months|Of the 146 subjects, 117 were included in the analysis, who had 2 or fewer missing monitoring visits. 84 subjects had complete data, 23 subjects had one missing visit and 10 subjects had 2 missing visits. For the 33 subjects with missing visits, data were carried forward. 68 subjects were non smokers and 49 subjects were current smokers.|||mm||Standard Error|Mean
1296562|NCT00065806|Secondary|Change in Homocysteine||Change from baseline to 36 months||||μmoles/liter||95% Confidence Interval|Mean
1296563|NCT00065806|Secondary|Change in Lipoprotein A||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
1296564|NCT00065806|Secondary|Change in Triglycerides||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
1296565|NCT00065806|Secondary|Change in LDL Cholesterol||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
1296566|NCT00065806|Secondary|Change in HDL Cholesterol||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
1296567|NCT00065806|Secondary|Change in Total Cholesterol||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
1296569|NCT00065806|Secondary|Change in Mean-Mean Near Wall CIMT|For the near wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common near wall mean, right bifurcation near wall mean, right internal near wall mean, left common near wall mean, left bifurcation wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296570|NCT00065806|Secondary|Change in Mean-Max Near Wall CIMT|For the near wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common near wall max, right bifurcation near wall max, right internal near wall max, left common near wall max, left bifurcation near wall max, and left internal near wall max). These 6 summary variables were then averaged to estimate a single mean-max near wall CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296571|NCT00065806|Secondary|Change in Mean-Mean Far Wall CIMT|For the far wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common far wall mean, right bifurcation far wall mean, right internal far wall mean, left common far wall mean, left bifurcation far wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296572|NCT00065806|Secondary|Change in Mean-Max Far Wall CIMT|For the far wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common far wall max, right bifurcation far wall max, right internal far wall max, left common far wall max, left bifurcation far wall max, and left internal far wall max). These 6 summary variables were then averaged to estimate a single mean-max far wall CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296573|NCT00065806|Secondary|Change in Mean-Mean Bifurcation CIMT|For the bifurcation arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right bifurcation near wall mean, right bifurcation far wall mean, left bifurcation near wall mean and left bifurcation far wall mean). These summary variables were then averaged to estimate a single mean-mean bifurcation CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296574|NCT00065806|Secondary|Change in Mean-Max Bifurcation CIMT|For each side and wall of the bifurcation arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right bifurcation near wall max, right bifurcation far wall max, left bifurcation near wall max and left bifurcation far wall max). These summary variables were then averaged to estimate a single mean-max bifurcation CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296575|NCT00065806|Secondary|Change in Mean-Mean Internal CIMT|For the internal carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right internal near wall mean, right internal far wall mean, left internal near wall mean and left internal far wall mean). These summary variables were then averaged to estimate a single mean-mean internal CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296576|NCT00065806|Secondary|Change in Mean-Max Internal CIMT|For each side and wall of the internal carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right internal near wall max, right internal far wall max, left internal near wall max and left internal far wall max). These summary variables were then averaged to estimate a single mean-max internal CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296577|NCT00065806|Secondary|Change in Mean-Max Common CIMT|For each side and wall of the common carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right common near wall max, right common far wall max, left common near wall max and left common far wall max). These summary variables were then averaged to estimate a single mean-max common CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296578|NCT00065806|Secondary|Change in Mean-Mean CIMT|For each side, segment and wall, mean CIMT values were averaged over the 4 angles of interrogation to produce 12 summary variables (right common near wall mean, right common far wall mean, right bifurcation near wall mean, right bifurcation far wall mean, right internal near wall mean, right internal far wall mean, left common near wall mean, left common far wall mean, left bifurcation near wall mean, left bifurcation far wall mean, left internal near wall mean and left internal far wall mean). These 12 summary variables were then averaged to estimate a single mean-mean CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296579|NCT00065806|Secondary|Change in Mean-Max CIMT|For each side, segment and wall, the maximum CIMT over the 4 angles of interrogation was selected to produce 12 summary variables (right common near wall max, right common far wall max, right bifurcation near wall max, right bifurcation far wall max, right internal near wall max, right internal far wall max, left common near wall max, left common far wall max, left bifurcation near wall max, left bifurcation far wall max, left internal near wall max and left internal far wall max). These 12 summary variables were then averaged to estimate a single mean-max CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296580|NCT00065806|Primary|Change in Mean-Mean Common Carotid IMT (CIMT)|For the common carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right common near wall mean, right common far wall mean, left common near wall mean and left common far wall mean). These summary variables were then averaged to estimate a single mean-mean common CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
1296581|NCT00014560|Secondary|Serum Markers of Macrophage Activation|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24|||||||
1297050|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 96|Percentage of participants with Viral Load < 400 copies/mL|week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1296583|NCT00014560|Primary|Clinical Toxicity|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|day 1-29|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).||||||
1296584|NCT00065611|Secondary|CKD-EPI eGFR|Estimate glomerular filtration rate (eGFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.|48 weeks from baseline||||ml/min/1.73m^2||Standard Deviation|Mean
1296585|NCT00065611|Secondary|Urine Protein||48 weeks from baseline||||g/d||Standard Deviation|Mean
1296586|NCT00065611|Primary|Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks|Complete remission is defined as proteinuria <0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria <3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as >60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response.|48 weeks from baseline|ITT|||participants|||Number
1296587|NCT00065507|Secondary|Number of Participants Undergoing Liver Transplant - On-Treatment or 24-Week Follow-Up||On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.|The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.|||participants|||Number
1296588|NCT00065507|Secondary|Number of Participants With Malignant Neoplasms - On Treatment or During 24-Week Follow-up Period|Data includes type of malignant neoplasm.|On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.|The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.|||participants|||Number
1296589|NCT00065507|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Flares - On Treatment|ALT flare=ALT > 2 x baseline and > 10 x upper limit of normal (ULN) by clinical laboratory evaluation. Table includes number of participants with selected clinical events and/or laboratory abnormalities during ALT flares. Selected clinical events during ALT flares=ascites, hepatic encephalopathy, jaundice, bacterial peritonitis. Selected Laboratory abnormalities during ALT flares=international normalized ratio > 1.5 or prothrombin time >= 1.2 x ULN and total bilirubin >2.5 mg/dL and > 1 mg/dL increase from baseline.|On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date.|Treated participants - as treated. The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.|||participants|||Number
1296590|NCT00065507|Secondary|Number of Participants With Treatment-Emergent Grade 3/4 Laboratory Abnormalities - Week 48 and Cumulative Data|Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 48 data set was used to evaluate the Week-48 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.|Week 48=all on-treatment laboratory measurements up to Week 48. Cumulative data = on-treatment laboratory measurements obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received).|||participants|||Number
1296591|NCT00065507|Secondary|Cumulative Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, HCC, Discontinuations Due to AEs, and Confirmed Creatinine Increase >=0.5 mg/dL|AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Confirmed increase in serum creatinine=values ≥0.5 mg/dL compared with baseline on 2 sequential measures.|on-treatment events obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received). Note that 5 additional enrolled participants died prior to initiation of treatment and are not included in this table.|||participants|||Number
1296592|NCT00065507|Secondary|Number of Hepatocellular Carcinoma (HCC) Events at Different Time Points Through Week 48|HCC-free survival was analyzed using life tables. Measured values show the number of HCC events among treated participants at given time points.|Week 48|Treated, through Week 48 - (analyzed as-treated). (Week 48 on-treatment safety data contain all on-treatment data up to study Day 336, if the subject is still on treatment. If the subject discontinued before study Day 336, then all data up to 5 days after the discontinuation date were included.) n=number of participants at risk at each timepoint.|||HCC events|||Number
1296593|NCT00065507|Secondary|Participants Achieving Platelet Count Normalization Through Week 48|Number of participants who achieved normalization of platelet count (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.|||participants|||Number
1296594|NCT00065507|Secondary|Participants Achieving Total Bilirubin Normalization Through Week 48|Number of participants who achieved normalization of total bilirubin (<= 1 x ULN), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.|||participants|||Number
1297083|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 72||Baseline to Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1296596|NCT00065507|Secondary|Participants Achieving Albumin Normalization Through Week 48|Number of participants who achieved normalization of albumin (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects (as randomized). Excludes subjects with normal albumin at Baseline. Non-completer = failure.|||participants|||Number
1296597|NCT00065507|Secondary|Change From Baseline in Platelet Count Through Week 48|Mean baseline platelet count and mean change from baseline in platelet count at specific timepoints. Platelets are the smallest particles found in the blood, which play a major role in forming blood clots. Normal range for platelets = 140 - 450 X 10*9 c/L.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.|||10*9 c/L||Standard Error|Mean
1296598|NCT00065507|Secondary|Mean Change From Baseline in Total Bilirubin Through Week 48|Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.|||mg/dL||Standard Error|Mean
1296599|NCT00065507|Secondary|Mean Change From Baseline in Prothrombin Time Through Week 48|Mean prothrombin time, and mean change from baseline in prothrombin time, a measure of synthetic liver function. Prothrombin time is the time it takes (in seconds) for a sample of blood to clot. Normal range for prothrombin time (PT) = 10-13 seconds.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.|||seconds||Standard Error|Mean
1296600|NCT00065507|Secondary|Change From Baseline in Albumin Through Week 48|Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated participants - as randomized; n=number of participants with value at baseline and given timepoint.|||g/dL||Standard Error|Mean
1296601|NCT00065507|Secondary|Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48|The EQ-5D has 5 attributes (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression), each with 3 levels (no problem, some problems, and major problems). This algorithm gives valuation (weights) to each of the 15 responses on the form. Each valuation is a negative number, subtracted from the maximum score of 1 (perfect well being). The overall health index score ranges from 0 (dead) to 1 (perfect health) value scale, and the visual analog scale ranges from 0 to 100. Item weights will be obtained from the EuroQol group.|Baseline, Week 24, Week 48|This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points.||||||
1296602|NCT00065507|Secondary|Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36)|Scoring for the SF-36 will be done using the algorithm developed by the Research ANd Development(RAND) Corporation (a scale of 0-100). Higher scores represent better quality of life. Coding for items with 2-category responses=0 and 100; 3-category=0/50/100; 5-category=0/25/50/75/100; 6-category=0/20/40/60/80/100. Scores of items in the same scale are combined to create the 8 scale scores (physical functioning, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, mental health). Physical and mental health composite scores will be computed for the group.|Baseline, Week 24, Week 48|This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points.||||||
1296603|NCT00065507|Secondary|Improvement or No Worsening in MELD Score Through Week 48|Participants with improvement or no worsening (any decrease or no change from baseline in score) in MELD score through Week 48. The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.|||Participants|||Number
1296604|NCT00065507|Secondary|Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48|Adjusted mean change from baseline in MELD score through Week 48 (adjusted for baseline value). The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated participants - as-randomized populations; n=number of participants with assessment at baseline and timepoint. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are obtained after the start of therapy and <=5 days after the last dose of study therapy.|||units on a scale||Standard Error|Mean
1296605|NCT00065507|Secondary|Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48|Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C.|Week 24, Week 48|Treated participants (as-randomized). The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|||Participants|||Number
1296606|NCT00065507|Secondary|Change From Baseline in Child-Pugh Score Through Week 48|Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.|||units on a scale||Standard Error|Mean
1296607|NCT00065507|Secondary|Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48|Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated participants (as-randomized). Non-completer=Failure. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|||Participants|||Number
1296608|NCT00065507|Secondary|>=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48|Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated Subjects-As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after start of therapy and <=5 days after the last dose of study therapy.) Non-completer=Failure. n=number of participants with measurement at baseline and timepoint.|||Participants|||Number
1296609|NCT00065507|Secondary|Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48||Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.|||Participants|||Number
1296610|NCT00065507|Secondary|Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48|Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal [ULN]) among those with baseline ALT >1.0 x ULN at Weeks 24 and 48|Week 24, Week 48|Treated Subjects - As-Randomized population, responders only (non-completer=failure).Participants in each group who achieved ALT normalization among those with baseline ALT >1.0 x ULN.|||Participants|||Number
1296611|NCT00065507|Secondary|Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48||Week 48|Treated Subjects - As-Randomized population, responders only (non-completer=failure).|||Participants|||Number
1296612|NCT00065507|Secondary|Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24||Week 24|Treated Subjects - As-Randomized population, responders only (non-completer=failure).|||participants|||Number
1296613|NCT00065507|Secondary|Change From Baseline in HBV DNA by PCR at Week 48|Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status.|Baseline, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 48 analysis window.|||log10 copies/mL||Standard Error|Mean
1296614|NCT00065507|Primary|Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24|Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis.|Baseline, Week 24|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 24 analysis window.|||log10 copies/mL||Standard Error|Mean
1296615|NCT00065468|Secondary|European Quality of Life Health Questionnaire (EQ-5D) - Index Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.|Baseline|ITT;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.|||units on a scale||Full Range|Median
1296616|NCT00065468|Secondary|Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)|The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the “dispersion” of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.|Baseline to Month 80|ITT|||months|||Number
1296617|NCT00065468|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.|Baseline, every month until tumor progression or death (up to Month 80)|ITT|||months||95% Confidence Interval|Median
1297084|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 64||Baseline to Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1296618|NCT00065468|Secondary|Duration of Response (DR)|DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.|Baseline, every month until tumor progression or death (up to Month 80)|ITT subset of participants who had a response|||months||95% Confidence Interval|Median
1296619|NCT00065468|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Baseline, every 2 months until tumor progression or death (up to Month 80)|ITT|||percentage of participants||95% Confidence Interval|Number
1296620|NCT00065468|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline, every 2 months until tumor progression or death (up to Month 80)|ITT|||percentage of participants||95% Confidence Interval|Number
1296621|NCT00065468|Secondary|Progression-Free Survival (PFS)|PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.|Baseline, monthly until tumor progression or death (up to Month 80)|ITT|||months||95% Confidence Interval|Median
1296622|NCT00065468|Primary|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline up to Month 80|Intent-to-treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
1296623|NCT00065442|Secondary|Time to Objective Disease Progression|Measured by imaging studies; confirmed by independent imaging review|Analysis conducted at the time of overall survival analysis||||Weeks||95% Confidence Interval|Median
1296624|NCT00065442|Primary|Overall Survival|Time from randomization until death due to any cause.|Event-driven timeframe. Final analysis at 331 events.||||Months||95% Confidence Interval|Median
1296625|NCT00065429|Primary|Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]|Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks. CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations. PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations. SD: does not qalify for PR or PD based on 2 observations. PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions|6 weeks|All patients with a baseline and follow up imaging scan were evaluated. Data represents information following the first cycle of treatment.|||participants|||Number
1296626|NCT00065429|Primary|Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)|Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.|every 6 weeks|All Phase I enrolled patients who received study drug were analyzed for DLTs.|||participants|||Number
1296627|NCT00065260|Secondary|Secondary Endpoints Will Include: Relapse; Clonal Evolution to Myelodysplastic Syndrome (MDS), Paroxysmal Nocturnal Hemoglobinuria (PNH) or Acute Leukemia||months/years|||||||
1296628|NCT00065260|Primary|No Longer Meeting Criteria for Severe Aplastic Anemia.||6 months||||participants|||Number
1296629|NCT00065156|Secondary|Participants With Bone Marrow Progression|"Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):~Baseline classification of refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) to a during treatment (plus 30 days) classification of refractory anemia with excess blasts (RAEB).~Any baseline FAB classification to a during treatment (plus 30 days) classification of acute myeloid leukemia (AML)."|up to 2 years|Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.|||participants|||Number
1296630|NCT00065156|Secondary|Participants With Complete or Partial Bone Marrow Improvement|Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist.|up to 2 years|Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.|||participants|||Number
1296631|NCT00065156|Secondary|Participant Counts of Absolute Neutrophil Count (ANC) Response|"Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of~≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days."|up to 2 years|Evaluable participants from the modified intent to treat population. Evaluable participants are required to have a baseline absolute neutrophil count (ANC) <1 * 10^9/L.|||participant|||Number
1296670|NCT00064701|Secondary|Change From Month 1 in Creatinine Clearance at Month 6 and Month 12|Renal function was assessed by creatinine clearance, calculated using the Cockcroft-Gault formula.|Month 1, Month 6, and Month 12|The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.|||mL/min||Standard Deviation|Mean
1296632|NCT00065156|Secondary|Participant Counts of Platelet Response|"Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence.~Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions."|up to 2 years|Evaluable participants from the modified intent to treat population. Participants must have a baseline platelet count <100 * 10^9/L to be included in the analysis.|||participants|||Number
1296633|NCT00065156|Secondary|Participant Counts of Cytogenetic Response|"Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least~1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline."|up to 2 years|Evaluable participants from the modified intent to treat population. Evaluable participants had ≥ 20 metaphases analyzed at baseline during the 56-day period immediately preceding the first day of study drug intake and ≥ 20 metaphases analyzed at least once at postbaseline visits.|||participants|||Number
1296634|NCT00065156|Secondary|Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders|The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline.|Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)|Modified intent to treat population who achieved transfusion independence|||g/dL||Standard Deviation|Mean
1296635|NCT00065156|Secondary|Kaplan Meier Estimate for Duration of Transfusion Independence Response|Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence.|up to 2 years|Modified intent to treat population who achieved transfusion independence|||weeks||95% Confidence Interval|Median
1296636|NCT00065156|Secondary|Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study|Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study.|up to 2 years|Modified intent to treat population who achieved transfusion independence|||participants|||Number
1296637|NCT00065156|Secondary|Time to Transfusion Independence|Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period.|up to 2 years|Modified intent to treat population who achieved transfusion independence|||weeks||Standard Deviation|Mean
1296638|NCT00065156|Secondary|Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study|A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment).|Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)|"Modified Intent to Treat (MITT)~diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation~received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period~received ≥1 dose of study drug"|||participant|||Number
1296639|NCT00065156|Secondary|Participants With Adverse Experiences|"Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|Up to 2 Years|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
1296640|NCT00065156|Primary|Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence|Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin.|Up to 2 years|"Modified Intent to Treat (MITT)~diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation~received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period~received ≥1 dose of study drug"|||participants|||Number
1296641|NCT00065065|Secondary|Number of Participants With Endoscopic Remission at 12 Weeks||12 weeks||||Participants|||Count of Participants
1296642|NCT00065065|Secondary|Number of Participants With Clinical Remission at 12 Weeks|Mayo Score <=2 at 12 weeks post intervention|12 weeks||||participants|||Number
1296643|NCT00065065|Primary|Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks|Mayo score decrease >=2 points adjusted for age and smoking status.|12 weeks||||participants|||Number
1296671|NCT00064701|Secondary|Change From Month 1 in Serum Creatinine at Month 6 and Month 12|Renal function was assessed by the change from Month 1 in serum creatinine six months and 12 months after transplant.|Month 1, Month 6, and Month 12|The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.|||mg/dL||Standard Deviation|Mean
1296644|NCT00003895|Primary|T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide|"Frequency measures obtained from each assay will be transformed to (common) logs for purposes of analysis. Repeated measures analyses will be performed on longitudinal data to assess patients’ immune response profiles over time. Comparability of assay methods will be assessed with correlation analyses, regression analyses, standard parametric and nonparametric tests, and agreement methods.~Pre- and post-immunization T-cell immunity to g209–2M peptide, to HPV16E7 peptide, and to a negative control HLA-A2 HIV peptide (pol) were assessed using HLA-A2/peptide tetramer-specific binding analysis. Within-subject analyses were performed to determine differences between pre- and postimmunization responses to the g209 –2M and HPV peptides and to the negative control HIV peptide after completion of 6 months of vaccination. Pre- versus postimmunization response differences were used as criterion measures in between-group (among subjects) analyses."|Baseline to 6 months|Patients were randomly assigned to two different vaccination schedules: group A received vaccinations every 2 weeks for 6 months (13 total injections), and group B received vaccinations every 3 weeks for 6 months (nine total vaccinations).|||% of CD8+ T cells||90% Confidence Interval|Mean
1296645|NCT00064987|Secondary|Fertility|Participants actively seeking to conceive.|24 months|Four subjects in Group 1 and two subjects in Group 2 were actively trying to conceive. Fertility was not tracked in subjects not trying to conceive.|||Participants|||Count of Participants
1296646|NCT00064987|Primary|Sperm Count|Average sperm count after treatment.|month 4 of GnRH treatment||||10^6 sperms/mL||Standard Deviation|Mean
1296647|NCT00064987|Primary|Testicular Size (Volume)|Average testicular volume after treatment.|at baseline and month 4 of GnRH treatment||||mL||Standard Deviation|Mean
1296648|NCT00064987|Primary|Inhibin B|Average Inhibin B Levels after treatment.|month 4 of GnRH treatment||||pg/mL||Standard Deviation|Mean
1296649|NCT00064987|Primary|Testosterone|Average Testosterone levels after treatment.|month 4 of GnRH treatment||||ng/dL||Standard Deviation|Mean
1296650|NCT00064987|Primary|FSH|Average Follicle Stimulating Hormone levels after treatment.|month 4 of GnRH treatment||||IU/L||Standard Deviation|Mean
1296651|NCT00064987|Primary|LH|Average Luteinizing Hormone levels after treatment.|month 4 of GnRH treatment||||IU/L||Standard Deviation|Mean
1296652|NCT00064844|Primary|12 Month Smoking Abstinence|Percentage of participants with prolonged carbon monoxide verified smoking abstinence|12 months after smoking quit date||||percentage of participants abstinent|||Number
1296653|NCT00064844|Primary|6 Month Smoking Abstinence|Percentage of participants with prolonged carbon monoxide verified smoking abstinence|6 months after smoking quit date||||percentage of participants abstinent|||Number
1296654|NCT00064753|Secondary|Renal Artery Revascularization|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296655|NCT00064753|Secondary|Abdominal Aortic Aneurysm Repair|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296656|NCT00064753|Secondary|Carotid Endarterectomy or Angioplasty|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296657|NCT00064753|Secondary|Lower Extremity Peripheral Arterial Disease (PAD)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296658|NCT00064753|Secondary|Coronary Artery Revascularization|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296659|NCT00064753|Secondary|CVD Death|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|P was calculated with stratified proportional hazards models stratified by country|||participants|||Number
1296660|NCT00064753|Secondary|Resuscitated Sudden Death (RSD)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296661|NCT00064753|Secondary|Fatal/Non-fatal Stroke|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296662|NCT00064753|Secondary|Fatal/Non-fatal Myocardial Infarction (MI)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296663|NCT00064753|Secondary|Mortality (All-cause)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
1296664|NCT00064753|Secondary|Renal Graft Failure||Up to 6 years (mean 4 years)|Intention-to-treat|||participants|||Number
1296665|NCT00064753|Primary|Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events||Up to 6 years (mean 4 years)|Censored at 3 months after return to dialysis|||participants|||Number
1296666|NCT00064792|Secondary|Cerebral Spinal Fluid Dehydrocholesterol to Total Sterol Ratio|Percent of 7-dehydrocholesterol + 8-dehydrocholesterol as a fraction of the total sterols (cholesterol + 7-dehydrocholesterol + 8-dehydrocholesterol measured in cerebral spinal fluid|12 months||||percent of total sterols||Standard Deviation|Mean
1296667|NCT00064792|Primary|Serum Cholesterol to Total Sterol Ratio|Total serum cholesterol (mg/dL) divided by the sum of all sterols (cholesterol plus its precursors, 7-dehydrocholesterol - 7DHC, and 8-dehydrocholesterol- 8DHC - in mg/dL).|1 year after therapy.|The number of participants was determined by the total number of participants to complete both phases of the trial (n=18).|||percent total cholesterol||Standard Deviation|Mean
1296668|NCT00064701|Secondary|Kaplan-Meier Estimate of Graft Survival at the End of the Study|"Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was any retransplant or the permanent return to dialysis (more than 30 days) or patient death.~Graft survival was censored at the time of last follow-up contact."|End of study (maximum time on study was 1,941 days).|The number of participants analyzed represents the full analysis set.|||percentage of participants||95% Confidence Interval|Number
1296669|NCT00064701|Secondary|Kaplan-Meier Estimate of Patient Survival at the End of the Study|Patient survival was defined as any participant who was alive at the end of the study. Patient survival was censored at the time of last follow-up contact.|End of study (maximum time on study was 1,941 days).|The number of participants analyzed represents the full analysis set.|||percentage of participants||95% Confidence Interval|Number
1297085|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 56||Baseline to Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1296672|NCT00064701|Secondary|Number of Participants Who Crossed Over Due to Treatment Failure|Participants were allowed to cross over to an alternative primary immunosuppressive regimen (either to the tacrolimus or cyclosporine treatment arms) to address an adverse event which led to randomized study drug discontinuation or in the case of severe or refractory rejection. Crossover to the modified release tacrolimus treatment arm was not permitted.|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
1296673|NCT00064701|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as the discontinuation of randomized study drug for any reason. Participants who met the definition of treatment failure were to be followed throughout the 12-month treatment period.|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
1296674|NCT00064701|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
1296675|NCT00064701|Secondary|Number of Participants Experiencing Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
1296676|NCT00064701|Secondary|Severity of Acute Rejection|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade IA: Significant interstitial infiltration and foci of moderate tubulitis; Grade IB: Significant interstitial infiltration and foci of severe tubulitis; Grade IIA: Mild to moderate intimal arteritis in at least 1 arterial cross section Grade IIB: Severe intimal arteritis comprising >25% of the luminal area lost in at least 1 arterial cross section; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set with a biopsy-confirmed acute rejection episode during one year.|||participants|||Number
1296677|NCT00064701|Secondary|Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Participants with histologically-proven Banff Grade II or III rejection or participants with steroid-resistant rejection were treated with anti-lymphocyte antibody treatment according to institutional practice.~Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
1296678|NCT00064701|Secondary|Time to First Biopsy-confirmed Acute Rejection Episode|"Time to first biopsy-confirmed acute rejection episode defined as the number of days from skin closure (Day 0) to the date of biopsy. Rejection episodes were confirmed by biopsy by the clinical site pathologist and graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~Acute rejection is defined as a grade ≥ I."|one year|The number of participants analyzed represents the full analysis set.|||days||Full Range|Median
1296679|NCT00064701|Secondary|Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~Acute rejection is defined as a grade ≥ I."|Six months and 12 months|The number of participants analyzed represents the full analysis set.|||percentage of participants|||Number
1296680|NCT00064701|Secondary|Graft Survival at One Year|"Graft survival defined as any participant who did not meet the criteria for graft loss, where graft loss is defined as any re-transplant, permanent return to dialysis (> 30 days), patient death, or participant whose outcome at one year was unknown.~Participants were only counted once regardless of how many criteria were met."|One year|The number of participants analyzed represents the full analysis set.|||percentage of participants|||Number
1296681|NCT00064701|Secondary|Patient Survival at One Year|Patient survival is defined as any participant who is known to be alive one year after the skin closure date. Participants who died or whose outcome was unknown at one year were considered to be non-survivors.|One year|The number of participants analyzed represents the full analysis set.|||percentage of participants|||Number
1296682|NCT00064701|Primary|Percentage of Participants With Efficacy Failure|"Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis [> 30 days] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up.~Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set, defined as all randomized patients who received at least one dose of study drug.|||percentage of participants|||Number
1296717|NCT00063986|Secondary|Duration of Operating Time|The length of the operation (total of thoracic and abdominal components) is recorded.|Assessed at surgery|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, 10 patients' length of operation data were unavailable, so the results are based on data from 94 patients.|||Minutes||Full Range|Median
1296683|NCT00064662|Primary|24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)|Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.|Two years|All participants randomized were included in time to event analysis|||% stress-specific success at 24 m||95% Confidence Interval|Number
1296684|NCT00064662|Primary|24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).|Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, <15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.|Two years|All participants randomized were included in time to event analysis.|||% success at 24 months||95% Confidence Interval|Number
1296685|NCT00064350|Secondary|Best Overall Response|The best overall response is the best response (per RECIST 1.0) recorded from randomization until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since randomization.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years||||Participants|||Number
1296686|NCT00064350|Secondary|Overall Survival|Overall survival is defined as the duration from randomization to death or last known alive. Only randomized patients were included in this analysis.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years||||Months||95% Confidence Interval|Median
1296687|NCT00064350|Secondary|Progression-free Survival|Progression-free survival is defined as the duration from randomization to disease progression or death, whichever occurs first. Only randomized patients were included in this analysis.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years.||||Months||95% Confidence Interval|Median
1296688|NCT00064350|Primary|Number of Patients Maintaining Stable Disease or Objective Response 2 Months After Randomization|"Per RECIST Criteria (V1.0):~Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions Progressive Disease (PD): >=20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of longest diameter recorded since randomization, or the appearance of new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|Two months after randomization||||participants|||Number
1296689|NCT00064337|Secondary|Hematologic Response||Until off study||||Participants|||Count of Participants
1296690|NCT00064337|Primary|Overall Survival|Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.|5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years|Eligible and analyzable patients only.|||Months||95% Confidence Interval|Median
1296691|NCT00064298|Secondary|Cell Proliferation (Ki-67) at Baseline and Week 12|Cell proliferation (Ki-67) at baseline and week 12. Ki67 is a cell proliferation associated nuclear protein. It is measured continuously. Higher values are worse.|baseline and 12 weeks|All participants randomized. Not all participants had p27 or Ki67 data so the sample sizes for the primary and secondary analyses differ from the overall sample size.|||percentage of cells||Standard Error|Mean
1296692|NCT00064298|Primary|Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12|Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.|baseline and 12 weeks|All randomized participants. Not all participants had p27 or Ki67 determined, so the sample sizes for the two outcomes differ from the total sample size.|||percentage of cells||Standard Error|Mean
1296693|NCT00064259|Secondary|Microarray Data|This will be primarily descriptive, and will seek to compare patterns of gene expression pre- and post-treatment.|Up to 12 weeks|||||||
1296694|NCT00064259|Primary|Maximum Tolerated Dose (MTD) of Oblimersen in Combination With Cisplatin and 5-FU|Adverse events were evaluated according to the National Cancer Institute Common Toxicity Criteria (version 2.0). DLT was defined as grade 3 to 4 hematologic toxicity lasting more than 1 week after 5-FU/cisplatin, grade 3 to 4 nausea or vomiting occurring later than 11 days after cisplatin, grade 3 to 4 diarrhea occurring later than 10 days after 5-FU, and grade 3 to 4 mucositis at the beginning of the next cycle.|21 days||||mg/kg/d|||Number
1296695|NCT00064077|Secondary|Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).|The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.|Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1|Patients who provided baseline and ≥ one follow-up assessments|||units on a scale||Standard Deviation|Mean
1296696|NCT00064077|Secondary|Pain, Assessed by Brief Pain Inventory|"Single item from the Brief Pain Inventory (BPI) assessing worst pain in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score."|Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1|Patients who provided baseline and ≥ one follow-up assessments|||units on a scale||Standard Deviation|Mean
1296718|NCT00063986|Secondary|Rate of Conversion to Open Operation|Proportion of patients who required conversion to operation will be reported.|Assessed at surgery|Eligible and treated patients are included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1296697|NCT00064077|Secondary|Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)|The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.|Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1|Patients who provided baseline and ≥ one follow-up assessments|||units on a scale||Standard Deviation|Mean
1296698|NCT00064077|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)|Evaluable (treatment)|||months||95% Confidence Interval|Median
1296699|NCT00064077|Secondary|Frequency of Response Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.|Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)|Evaluable (treatment)|||Participants|||Count of Participants
1296700|NCT00064077|Primary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)|Evaluable (treatment)|||months||95% Confidence Interval|Median
1296701|NCT00064038|Primary|Progression-Free Survival|"Progression is defined as a > 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.~In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs."|From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years||||percentage of participants||95% Confidence Interval|Number
1296702|NCT00064038|Secondary|Toxicity|Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.|From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years|All participants receiving at least one dose of induction therapy|||Participants|||Number
1296703|NCT00064025|Secondary|Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression|Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.|During the hysterectomy , which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)|||Aggregate Score from Immunohistochemistr||Standard Error|Mean
1296704|NCT00064025|Secondary|Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression|Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.|During the hysterectomy, which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)|||Aggregate Score from Immunohistochemistr||Standard Error|Mean
1296719|NCT00063986|Primary|Peri-operative Mortality at 30 Days|The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.|Assessed at 30 days from surgery|Eligible and treated patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
1296720|NCT00063934|Secondary|Bcl-2 Expression in Breast Cancer Tissue|Number of participant with Bcl-2 Expression in breast cancer tissue by protein and mRNA expression before treatment and at 3-5 days after oblimersen treatment.|before treatment and at 3-5 days after oblimersen treatment||||participants|||Number
1296737|NCT00063622|Secondary|Number of Participants With Improvement in Hepatocellular Ballooning|Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning. This secondary outcome measure is the number of participants that experienced a decrease in hepatocellular ballooning score, which indicates improvement in hepatocellular ballooning.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
1296705|NCT00064025|Primary|Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative|"To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data.~PR Positivity is based on aggregate score >0.2 (vs. <=0.2). Aggregate score based on product of staining intensity and area."|During the hysterectomy, which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy and had histologic response data)|||percentage of participants|||Number
1296706|NCT00063999|Secondary|Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection|Maximum grade of physician assessed neurotoxicity and infection|Assessed throughout the treatment period and for 30 days after discontinuation of treatment.|Eligible and treated patients|||Participants|||Count of Participants
1296707|NCT00063999|Secondary|Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)|The time alive in months from study entry to last contact or death.|Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.|Eligible patients with estrogen and progesterone receptor data.|||Participants|||Count of Participants
1296708|NCT00063999|Secondary|Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G|The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.|Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment|Eligible and evaluable and enrolled prior to 3/26/2006|||units on a scale||Standard Error|Least Squares Mean
1296709|NCT00063999|Secondary|Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)|The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).|Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start|Eligible and evaluable and enrolled prior to 3/26/2006|||units on a scale||Standard Error|Least Squares Mean
1296710|NCT00063999|Primary|Number of Participants Alive at Time of Last Follow-up.|The time alive in months from study entry to last contact or death.|Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.|Eligible and treated patients. Data are reported from the second interim analysis.|||Participants|||Count of Participants
1296711|NCT00063986|Secondary|Rate of Conversion to Open Operation After Neoadjuvant Therapy|Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.|Assessed at surgery|35 eligible and treated patients with neoadjuvant therapy are included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1296712|NCT00063986|Secondary|30-day Peri-operative Mortality After Neoadjuvant Therapy|Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.|Assessed at 30 days after surgery|35 eligible and treated patients with neoadjuvant therapy are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
1296713|NCT00063986|Secondary|3-year Survival Rate|Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.|Assessed at 3 years|Eligible and treated patients are included in this analysis.|||proportion of participants||95% Confidence Interval|Number
1296714|NCT00063986|Secondary|Total Number of Lymph Nodes Dissected|The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.|Assessed at surgery|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, the number of lymph nodes removed is missing for 1 patient, so the results are based on data from 103 patients.|||Lymph nodes||Full Range|Median
1296715|NCT00063986|Secondary|Overall Length of Hospital Stay|The number of days patients stayed in the hospital after surgery is reported.|Assessed after surgery until patients are out of hospital|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of hospital stay is missing for 3 patients, so the results are based on data from 101 patients.|||Days||Full Range|Median
1296716|NCT00063986|Secondary|Duration of Intensive Care Stay|Number of post-operative days in intensive care is reported.|Assessed after surgery until patients are out of intensive care|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of intensive care stay is missing for 3 patients, so the results are based on data from 101 patients.|||Days||Full Range|Median
1296721|NCT00063934|Secondary|Clinical Imaging Responses|Evaluation target lesions (clinical response) by physical exam/ultrasound measurements of primary tumor and axillary lymph nodes after 3-6 courses: Complete Response: Disappearance of all target lesions; Partial Response: >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1>new lesions; Stable Disease: Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum LD since treatment started.|After 3 and 6 courses of 21 day treatments (up to 18 weeks)||||participants|||Number
1296722|NCT00063934|Primary|Number of Participants With Pathologic Complete Response (pCR)|Pathologic complete responses (pCR), defined as no evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes, measured by microscopic evaluation of tissue specimen at time of definitive surgery (after 6 courses of neoadjuvant therapy). Neoadjuvant (preoperative) therapy administered on the first five days of every 3-week cycle. Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]|At time of definitive surgery (after 6 courses of neoadjuvant therapy in 3 week cycles), approximately 18 weeks|Intention to treat eligible participants per protocol.|||Participants|||Number
1296723|NCT00063934|Primary|Participant Toxicity|Incidence of toxicity summarized using NCI Common Toxicity Criteria, version 3.0 every 3 weeks.|From baseline to study completion, every 3 weeks|||||||
1296724|NCT00063635|Secondary|Change in QOL- Psychosocial Health|Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.|baseline and 96 weeks||||units on a scale||95% Confidence Interval|Mean
1296725|NCT00063635|Secondary|Change in Quality of Life (QOL) Scores- Physical Health|Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.|baseline and 96 weeks||||units on a scale||95% Confidence Interval|Mean
1296726|NCT00063635|Secondary|Change in Serum Vitamin E Levels|Change in alpha-Tocopherol|baseline and 96 weeks||||mg/L||95% Confidence Interval|Mean
1296727|NCT00063635|Secondary|Change in Body Mass Index||baseline and 96 weeks||||kg/m-squared||95% Confidence Interval|Mean
1296728|NCT00063635|Secondary|Number of Participants With Improvement in Ballooning Degradation Score|Ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe ballooning. This secondary outcome measure is the number of participants that experienced a decrease in ballooning score at 96 weeks compared to baseline, which indicates improvement in ballooning.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||participants|||Number
1296729|NCT00063635|Secondary|Number of Participants With Improvement in Lobular Inflammation Score|Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score at 96 weeks compared to baseline, which indicates improvement in lobular inflammation.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||participants|||Number
1296730|NCT00063635|Secondary|Number of Participants With Improvement in Steatosis Score|Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score at 96 weeks compared to baseline, which indicates improvement in steatosis.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||participants|||Number
1296731|NCT00063635|Secondary|Number of Participants With Improvement in Liver Fibrosis Score|Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score at 96 weeks compared to baseline, which indicates improvement in fibrosis.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||participants|||Number
1296732|NCT00063635|Secondary|Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment|Histological activity was assessed using the NAFLD activity score on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (0-3), lobular inflammation (0-3), and hepatocellular ballooning (0-2).|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||units on a scale||95% Confidence Interval|Mean
1296733|NCT00063635|Secondary|Change in Serum Aspartate Aminotransferase (AST)||baseline and 96 weeks||||IU/L||95% Confidence Interval|Mean
1296734|NCT00063635|Primary|Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L|The primary outcome was sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 IU/L or less at each visit from 48 to 96 weeks of treatment.|baseline and 96 weeks|All enrolled patients were included in analysis of the primary outcome, sustained reduction in ALT level. Patients missing a 96-week ALT measurement were imputed as not achieving a sustained reduction.|||participants|||Number
1296735|NCT00063622|Secondary|Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis|The criteria for nonalcoholic steatohepatitis was definite or possible steatohepatitis (assessed by a pathologist) with an activity score of 5 or more, or definite steatohepatitis (confirmed by two pathologists) with an activity score of 4. This secondary outcome measure is the number of participants who met this definition at baseline and did not meet this definition after 96 weeks of treatment and thus had a resolution of steatohepatitis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
1296736|NCT00063622|Secondary|Number of Participants With Improvement in Fibrosis|Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score, which indicates improvement in fibrosis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
1296738|NCT00063622|Secondary|Number of Participants With Improvement in Lobular Inflammation|Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score, which indicates improvement in lobular inflammation.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
1296739|NCT00063622|Secondary|Number of Participants With Improvement in Steatosis|Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score, which indicates improvement in steatosis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
1296740|NCT00063622|Primary|Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment.|Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2). The primary outcome was an improvement in histological findings from baseline to 96 weeks, which required an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.|baseline and 96 weeks|All randomized participants were included in the analysis of the primary outcome.|||participants|||Number
1296741|NCT00063570|Secondary|Overall Survival|Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated||||months||Full Range|Median
1296742|NCT00063570|Secondary|Time to Treatment Failure|Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12)|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Intention to Treat analysis|||months||Full Range|Median
1296743|NCT00063570|Secondary|Time to Progressive Disease|Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Intention to Treat analysis|||months||Full Range|Median
1296744|NCT00063570|Secondary|Duration of (Confirmed) Complete Response or Partial Response|Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Number of patients with a confirmed complete or partial response.|||months||Full Range|Median
1296745|NCT00063570|Primary|Overall Tumor Response|Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Patients who received at least one dose of study drug (pemetrexed or gemcitabine) were included in the analyses.|||participants|||Number
1296746|NCT00063362|Primary|The Proportion of Patients Who Experience a Marked and Persistent Bimodal Response|"A marked bimodal response is defined by the following three conditions over four consecutive weeks while on triple therapy and after three weeks of ltg:~Montgomery Asberg Depression Rating Scale (MADRS) total score of <= 19~Young Mania Rating Scale (YMRS) total score of <= 12.5~Global Assessment Scale (GAS) score >= 51~The MADRS measures the severity of a subject's depression symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe depression.~The YMRS measures the severity of a subject's manic symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe mania.~The GAS measures a used to rate subjectively the social, occupational, and psychological functioning of a subject and ranges in score from 0-100, with a higher score indicating better social, occupational, and psychological functioning."|Baseline and Week 28||||participants|||Number
1296747|NCT00063258|Primary|Number of Patients With Response|Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery.|5 Years to collect outcome information|Analysis limited since of 5 participants enrolled, only 1 evaluable for response.|||Participants|||Number
1296748|NCT00063154|Secondary|Number of Participants Free From Disease Progression at 3, 6, and 12 Months|Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.|||participants|||Number
1296749|NCT00063154|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the first day of pertuzumab treatment (Cycle 1, Day 1) to the time of documented disease progression (per RECIST) or death, whichever occurred first.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.|||weeks||95% Confidence Interval|Median
1296750|NCT00063154|Secondary|Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.|||participants|||Number
1296751|NCT00063154|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.|||percentage of participants|||Number
1296752|NCT00063232|Secondary|Change in Insulin Sensitivity (Glucose Tolerance, Homeostatic Model Assessment of Insulin Resistence (HOMA-IR)) From Baseline|HOMA-IR is calculated from Fasting Glucose and Fasting Insulin|from baseline to 48 weeks||||unit||Standard Deviation|Mean
1296753|NCT00063232|Secondary|Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category)|Alanine transaminase <42 U/L is considered normal|from baseline to 48 weeks||||participants|||Number
1296754|NCT00063232|Primary|Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category)|Patients under went liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint is a three point improvement in the histological NASH activity index with a decrease in at least two of the component scores and no worsening of fibrosis or increase in Mallory bodies.|from baseline to 48 Weeks||||participants|||Number
1296755|NCT00062764|Secondary|Mean BMI Change||48 weeks||||kg/m2||Standard Deviation|Mean
1296756|NCT00062764|Secondary|Average Increase in Weight After Treatment||48 weeks||||kg||Full Range|Mean
1296757|NCT00062764|Secondary|Mean Increase of Insulin Sensitivity Index||48 weeks||||percentage||Standard Deviation|Mean
1296758|NCT00062764|Secondary|Number of Patients With Impaired Glucose Tolerance After Treatment||48 weeks||||participants|||Number
1296759|NCT00062764|Primary|Number of Patients With Improvement in Liver Histology|A histological response was defined as a reduction in the NASH activity index by 3 points or more with improvements of at least 1 point each in steatosis, parenchymal inflammation, and hepatocellular injury.|48 weeks||||participants|||Number
1296760|NCT00062751|Secondary|24-hour Trough Concentration (C Trough)|C trough in whole blood measured as nanograms per milliliter (ng/mL).|Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12|ITT; Final analysis was not conducted.|||ng/mL||Standard Deviation|Mean
1296761|NCT00062751|Secondary|Area Under the Concentration-time Curve (AUC) Sum|Area under the concentration-time curve to infinity (AUC) measured as hours multiplied by nanograms divided by milliliters (hr*ng/mL) for CCI-779, sirolimus and letrozole. Sum is calculated as the sum of CCI-779 plus sirolimus AUCs (AUCsum).|Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12|ITT; Final analysis was not conducted.|||hr*ng/mL||Standard Deviation|Mean
1296762|NCT00062751|Secondary|Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27|Number of participants with antitumor response (CR [disappearance of all target and non-target lesions with normalization of tumor marker level] or PR [at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD]) in relation to plasma levels of Akt phosphorylation, cyclin D1, PTEN, and p27.|Prior to baseline, after Cycle 4 (Week 8), after Cycle 8 (Week 14), and cross-over or final visit (within 15 days of stopping study treatment)|ITT; Final analysis was not conducted.|||participants|||Number
1296801|NCT00061373|Secondary|Bleeding Events|Bleeding events of any type, severity and at any time throughout the 30-day trial period.|2 hr, 24 hr, 72 hr, 5 days, 30 days from start of study drugs|All bleeding events that occurred among all patients enrolled and throughout the 30-day trial period but not classified as a primary outcome event. Bleeding events in this category include asymptomatic ICH(aICH);major systemic bleeding after 72 hours or minor and non-significant bleeding at anytime within the 30-day period.|||participants|||Number
1296763|NCT00062751|Secondary|Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23|Assess specificity of breast cancer symptoms relevant to participant's perceived quality of life (disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm or shoulder pain, breast pain, swollen breast, and skin problems on the breast). 23-item assessment of symptoms or problems during the past week (items 1-13 and 17-23) or during the past 4 weeks (items 14-16); range from 1 (not at all) to 4 (very much). Index scores transformed and range from 0 to 100; higher scores indicate higher level of functioning and quality of life.|Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)|ITT; Final efficacy analysis was not conducted.|||scores on a scale|||Number
1296764|NCT00062751|Secondary|Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)|ITT; Final efficacy analysis was not conducted.|||scores on a scale|||Number
1296765|NCT00062751|Secondary|Number of Participants With Survival|Number of participants with survival (alive) in the interval from start of treatment to last contact for participant or death as a result of any cause.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) until death|ITT; Final efficacy analysis was not conducted.|||participants|||Number
1296766|NCT00062751|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that reoccurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started; the minimal time interval for duration of SD is 8 weeks.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.|||days||Standard Deviation|Mean
1296767|NCT00062751|Secondary|Percentage of Participants Exhibiting Freedom From Progression|Freedom from progression defined as CR (disappearance of all target and non-target lesions with normalization of tumor marker level), PR (at least a 30% decrease in sum of the LD of target lesions taking as reference the screening sum LD), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions]).|Baseline, 8 weeks, 6 months, 12 months, and 24 months|ITT; Final efficacy analysis was not conducted.|||percentage of participants|||Number
1296768|NCT00062751|Secondary|Time to Treatment Failure|Number of days to treatment failure defined as interval from start of treatment to first date of progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death or discontinuation of treatment due to Adverse Event, censored at last evaluation.|Baseline until Progressive disease, death, or discontinuation of study treatment|ITT; Final efficacy analysis was not conducted.|||days||Standard Deviation|Mean
1296769|NCT00062751|Secondary|Time to Disease Progression|Number of days to disease progression defined as the interval from the date of randomization until the first date that recurrence or progression is documented; progression (at least 20% increase in the sum of the LD of target lesions taking as reference the smallest sum of LD; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions).|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.|||days||Standard Deviation|Mean
1296770|NCT00062751|Secondary|Percentage of Participants With Best Overall Response (Clinical Benefit)|Best response (CR, PR, or stable disease (SD) lasting ≥6 months) recorded from baseline to disease progression or recurrence (Progressive disease [PD]). CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR is ≥30% decrease in sum of LD of target lesions; SD=neither sufficient shrinkage to=PR nor sufficient increase to=PD, referencing smallest sum LD since treatment started; PD is ≥20% increase in sum of LD of target lesions referencing smallest sum of LD; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.|||percentage of participants||95% Confidence Interval|Number
1296771|NCT00062751|Primary|Percentage of Participants With Objective Response (OR)|OR measured as Complete response (CR) or Partial response (PR) confirmed by assessments performed no less than 4 weeks after the criteria for the response are first met. CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD. Target lesions=all measurable lesions up to 5 lesions per organ (10 lesions in total), representative of all involved organs, if possible; recorded and measured at screening. Non-target lesions=all other lesions.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression|Intent to treat population (ITT) defined as all participants randomized in the study. Final efficacy analysis was not conducted because the development of temsirolimus (CCI-779) for the treatment of breast cancer was terminated.|||percentage of participants||95% Confidence Interval|Number
1296772|NCT00062738|Secondary|Percent Responders|Percent of patients who had a 50% decrease in total HDRS at 8 weeks|8 weeks|intent to treat|||percent of patients who were responders|||Number
1296773|NCT00062738|Primary|Hamilton Depression Scale|total score on HDRS (0-54 higher score is worse)|8 weeks|intent to treat - total patients in the arm|||units on a scale||Standard Deviation|Least Squares Mean
1296863|NCT00058825|Secondary|2-year Relapse-free Survival|Relapse-free survival (RFS) was calculated from the time of transplant to the date of relapse, death, or last follow-up, whichever occurred first. Survival data were analyzed by Kaplan-Meier method.|2 years||||percentage of participants||95% Confidence Interval|Number
1296774|NCT00062647|Primary|Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation|Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.|12 weeks after start of treatment|The primary efficacy analysis was of the CE Population, defined as those patients meeting meeting inclusion/exclusion criteria, meeting continuation criteria, receiving assigned study drug for at least 14 days and available for assessment of response.|||participants|||Number
1296775|NCT00062439|Secondary|Response|Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.|After completion of induction therapy.|Eligible patients who began the treatment regimen and who had measurable disease (per RECIST) at baseline were included in the analysis of response.|||percentage of participants||95% Confidence Interval|Number
1296776|NCT00062439|Secondary|Progression-Free Survival at 3 Years|Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.|At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment.|Eligible patients who began the treatment regimen were included in the analysis.|||percentage of patients||95% Confidence Interval|Number
1296777|NCT00062439|Secondary|Overall Survival|The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.|Eligible patients who began the treatment regimen were included in the analysis.|||years||95% Confidence Interval|Median
1296778|NCT00062439|Primary|Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.|Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.|After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel|Eligible patients who began the treatment regimen were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1296779|NCT00062439|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.|Eligible patients who received the study intervention.|||Participants|||Number
1296780|NCT00062374|Other Pre-specified|Disease Free Survival (DFS)|Overall Survival (OS) and Disease Free Survival (DFS) are the secondary endpoints. Technical problems with measurement of OS leading to unreliable or uniterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only DFS data is being reported.|Every 3 mos for the first 2 yrs, then every 6 mos for 2 years and once a year afterwards, up to 5 years|Technical problems with measurement leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated.|||months||95% Confidence Interval|Median
1296781|NCT00062374|Primary|Histological Response Determined by FDG Uptake Correlates|"The primary objective was to demonstrate that a decrease in FDG-SUV discriminates treatment response. Response was defined pathologically based on microscopic inspection for residual cancer cells and fibrosis.~Using a two sample t-test, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders. Data adjudication was invalid, and needs to be re-adjudicated~Non-Responder= Tumor Regression Grade 3 or higher Responder=Tumor Regression Grade 1 (CR) or Grade 2 (PR)"|Day 15|Technical problems with measurement of FDG-SUV data leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only histological response is reported.|||participants|||Number
1296782|NCT00062166|Secondary|Number of Participants With Missense or Non-missense Mutations|Count of participants by the type of Von Hippel-Lindau (VHL) gene mutations.|8 years||||Participants|||Count of Participants
1296783|NCT00062166|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|8 years||||Participants|||Count of Participants
1296784|NCT00062166|Secondary|Number of Participants From Which We Obtained Tissue From Pancreatic Lesions and Normal Tissue for Genetic Analysis|Count of participants from which we obtained tissue from pancreatic tumor and normal tissue (when applicable) for Deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and proteins extraction.|initiation of study therapy until 2009, approximately 6 years|Only 319/340 records are available in the database program for this outcome measure. No records are available for the remaining 21 participants.|||Participants|||Count of Participants
1296785|NCT00062166|Secondary|Percentage of Participants With Exon 3 Mutation Compared to Participants With Exon 1 or 2 Von Hippel Lindau (VHL) Mutations Who Required an Intervention|Percentage of patients by the location of germline VHL mutations.|8 years|The exon mutation information only is available in 63 patients. This protocol did not repeat the gene testing in any of the patients.|||percentage of participants|||Number
1296864|NCT00058825|Secondary|Chronic Graft Versus Host Disease|Number of patients with Chronic Graft Versus Host Disease within 1 year post-transplant|1 year||||participants|||Number
1296786|NCT00062166|Primary|Number of Patients With Pancreatic Lesions Defined by Simple Cysts, Microcystic Adenomas, Neuroendocrine Tumors & Other Solid Lesions of the Pancreas Who Had Significant Growth in Lesions or Symptoms Related to the Lesions Requiring Surgical Intervention|Pancreatic lesions defined by simple cysts, microcystic adenomas, neuroendocrine tumors and other solid lesions of the pancreas were evaluated by 18F Fludeoxyglucose (18F-FDG-PET) imaging to determine if the participant developed metastatic disease (e.g. tumor spreads to different organs).|8 years|Only 319/340 records are available in the database program for this outcome measure. No records are available for the remaining 21 participants.|||Participants|||Count of Participants
1296787|NCT00062010|Secondary|Progression-free Survival|Time from registration to documented disease progression (RECIST criteria) or death.|Assessed every 6 weeks|Eligible, treated patients|||months||95% Confidence Interval|Median
1296788|NCT00062010|Secondary|Survival|Time from registration to death.|Assessed every 3 months for 1 year then every 6 months|Eligible, treated patients|||months||95% Confidence Interval|Median
1296789|NCT00062010|Primary|Response by RECIST Criteria (v 1.0)|Number of eligible, treated participants in each response category by RECIST criteria|Assessed every 6 weeks|Eligible, treated patients|||participants|||Number
1296790|NCT00061945|Post-Hoc|Number of Participants Achieving Complete Remission|A complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) > 1500/μl, no circulating blasts, platelets > 100,000/μl; bone marrow cellularity > 20% with trilineage hematopoiesis, and < 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement).|Duration of study (up to 10 years)|Three participants were deemed ineligible and excluded from this analysis.|||participants|||Number
1296791|NCT00061945|Secondary|Overall Survival (Phase II)|Will be estimated using the Kaplan-Meier method with confidence intervals presented.|3 years|||||||
1296792|NCT00061945|Secondary|Disease-free Survival (Phase II)|Will be estimated using the Kaplan-Meier method with confidence intervals presented.|3 years|||||||
1296793|NCT00061945|Secondary|Modulation of Minimal Residual Disease During Treatment With Alemtuzumab (Phase II)||Up to 10 years|||||||
1296794|NCT00061945|Primary|Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)|The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.|8 months|Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.|||participants|||Number
1296795|NCT00061945|Primary|Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)|The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.|6 weeks|Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.|||mg|||Number
1296796|NCT00061932|Secondary|Change in Patterns of Gene Expression Pre- and Post-treatment Performed by GeneChip Analysis||Baseline to 6 years|||||||
1296797|NCT00061932|Primary|True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria|Up to 6 years||||participants||95% Confidence Interval|Number
1296798|NCT00061893|Secondary|Event Free Survival||24 months after start of protocol therapy|By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of Event Free Survival. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.|||percentage of participants||95% Confidence Interval|Number
1296799|NCT00061893|Primary|Occurrence of Severe Toxicity|An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity.|The first two cycles (6 weeks) of protocol chemotherapy|By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of severe toxicity. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.|||participants|||Number
1296800|NCT00061633|Primary|Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|"Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.~Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit.~Indeterminate: Inability to determine outcome."|7-14 days following end of antibiotic treatment|"The CE population were a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population."|||participants|||Number
1296865|NCT00058825|Secondary|Acute Graft Versus Host Disease|Number of patients with Acute Graft Versus Host Disease within 100 days post-transplant|100 days||||participants|||Number
1296802|NCT00061373|Primary|Non-MRI Selected Arm: Substantial Clinical Recovery (Non-MRI Arm)|"This is the primary response outcome measure for subjects in the non-MRI arm. A positive response is measured by a 7 point or more improvement in the NIHSS or for those with less than 7 points at baseline,complete resolution of stroke symptoms.~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms."|up to 24 hours from the start of study drugs|Clinical improvement on NIHSS of 7 points or greater at 72 hours is the primary response outcome for non-MRI selected patients. Clinical response outcome was analyzed on all patients enrolled; MRI selected and non-selected patients.|||participants|||Number
1296803|NCT00061373|Primary|MRI Selected Arm: Complete Brain Reperfusion|This is the primary response outcome measure for patients in the MRI arm. A positive response is measured by evidence of complete reperfusion (or restoration of blood flow)on the perfusion weighted images (PWI) and mean transit time (MTT) maps of MRIs at 2 hours and sustained at 24 hours.|up to 24 hours from the start of study drugs|Complete reperfusion at 2 and 24 hours was measured in MRI-selected patients only.|||participants|||Number
1296804|NCT00061373|Primary|Other Serious Adverse Event Related to Study Drug Administration, Including Death.|This is a primary safety outcome for all subjects.|From start of study drugs and prior to 72-hour head CT|All Patients completed 72-hour study safety evaluation|||participants|||Number
1296805|NCT00061373|Primary|Major Systemic Hemorrhage|Major systemic hemorrhage is defined bleeding associated with an adjusted decrease in hemoglobin of greater than 5 grams per diluent (g/dL), or and adjusted decrease in hematocrit greater than or equal to 15 percentage points or bleeding causing persistent or significant disability or incapacity such as hemorrhage in the eye.|From the start of study drugs and prior to 72-hour head CT|All patients completed 72-hour safety evaluation|||participants|||Number
1296806|NCT00061373|Primary|Symptomatic Intracerebral Hemorrhage (ICH)|"This is a primary safety outcome or toxicity measure for all subjects.~Symptomatic ICH is defined as the presence of two conditions: evidence of hemorrhage on the 72-hour head CT and an increase in the NIHSS score of 4 or more points from the prior examination. Hemorrhage classifications are according to European Cooperative Acute Stroke Study (ECASS).~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms."|From the start of study drugs and prior to the 72-hour safety head CT|All patients had a 72-hour safety head CT performed|||participants|||Number
1296807|NCT00061048|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18 months||||participants|||Number
1296808|NCT00061048|Secondary|Cell Surface Expression of CD52 on Tumor Cells|The CD52 antibody-binding capacity (ABC) value is the measurement of the mean value of the maximum capacity of each cell to bind the anti-CD52 and when determined under conditions of saturating levels of antibody measures number of mean surface CD52 antigens per cell. CD52 ABC is negative when 100% saturation by therapeutic antibody is achieved.|6 months||||ABC value||Standard Deviation|Mean
1296809|NCT00061048|Primary|Time to Progression|Time between the first day of treatment to the day of disease progression which is defined as a persistent (at least two determinations) doubling of the peripheral blood leukemic cell count, the development of new lesions, or Ca elevations that are uncontrolled by conventional therapeutic procedures.|60 months||||months||95% Confidence Interval|Median
1296810|NCT00061048|Primary|Overall Survival|Time between the first day of treatment to the day of death.|60 months||||months||95% Confidence Interval|Median
1296811|NCT00061048|Primary|Overall Response Rate|"Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition.~Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma.~Please see the protocol Link module for the full criteria if desired."|60 months||||percentage of participants||95% Confidence Interval|Number
1296812|NCT00060944|Secondary|Overall Survival|The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.|||months||95% Confidence Interval|Median
1296813|NCT00060944|Secondary|Progression-Free Survival - Independent Review|The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.|||months||95% Confidence Interval|Median
1296814|NCT00060944|Secondary|Duration of Response - Independent Review|Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. Participants with confirmed response only were analyzed.|||Months||95% Confidence Interval|Median
1296815|NCT00060944|Secondary|Percentage of Participants Objective Response - Independent Review|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.|||Percentage of participants||95% Confidence Interval|Number
1296816|NCT00060944|Primary|Time to Progression- Independent Review|Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.|||months||95% Confidence Interval|Median
1296817|NCT00060840|Primary|The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide.|"Failure criteria used to measure outcome includes:~Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2~Administration of ≥ 20 inotropic equivalents (IE)~Mean arterial pressure (MAP) ≤ 55 mm Hg~Central venous pressure (CVP) ≥ 16 mm Hg~Percentage of mixed venous oxygen saturation (SvO2) of ≤ 55% OR failure to wean from cardio pulmonary bypass (CPB) at least once due to hemodynamic failure or death."|28 days|The analysis was determined for intent-to-treat population.|||Participants|||Number
1296818|NCT00060528|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|77.5 months||||Participants|||Count of Participants
1296819|NCT00060528|Secondary|Overall Survival|Overall survival is defined as the date of on-study to the date of death from any cause or last follow-up.|50 months||||Months||Full Range|Median
1296820|NCT00060528|Secondary|Number of Participants With an Objective Response|Objective response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria defined as: measurable disease (at least one measurable lesion), measurable lesions (lesions that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral CT scan. Non-measurable lesions (all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan), i.e. bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion...|53 months|All 12 participants with measurable disease were evaluated.|||Participants|||Count of Participants
1296821|NCT00060528|Secondary|Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels|PSA level at the time treatment is initiated compared to the PSA level at Day 85 and monthly thereafter while the patient continues on trial)|53 months|PSA was taken at multiple time points and proportion of patients (pts) who had a decrease in PSA of at least 30% was reported. This is standard reporting procedures for tumor markers (proportion of patients with a response);similar to RECIST reporting where there may be multiple scans obtained but one reports the proportion of pts with a response|||Percentage of participants|||Number
1296822|NCT00060528|Primary|Number of Participants With an Immune Response|Immune response is defined as an enhanced PSA specific T-cell immune response greater than or equal to twofold post-vaccination. Peripheral blood mononuclear cells (PBMCs) were collected by apheresis prior to treatment with vaccination and after approximately three months of therapy.|48 months||||Participants|||Count of Participants
1296823|NCT00060424|Secondary|Transplant-related Mortality|Defined as death before day +200 not related to progression of disease.|At 200 days||||Participants|||Count of Participants
1296824|NCT00060424|Secondary|Rate and Types of Infections|Number of infections patients experienced, by infection type.|18 months||||infections|||Number
1296825|NCT00060424|Secondary|Acute Grade II-IV GVHD and Chronic (Extensive) GVHD|"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.||||Participants|||Count of Participants
1296826|NCT00060424|Secondary|Rate of Relapse|Number of patients with relapsed disease post-transplant. Relapse/progression is defined as 1) Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, 2) circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, or 3) lymph node Biopsy Richter’s transformation.|18 months||||Participants|||Count of Participants
1296827|NCT00060424|Primary|Overall Survival|Number of patients surviving 18 months post-transplant.|At 18 months||||Participants|||Count of Participants
1296828|NCT00060346|Primary|Objective Response to Treatment|Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.|Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry|All eligible and treated patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
1296866|NCT00058825|Secondary|Donor Chimerism Engraftment of Greater Than 50%|Number of patients that engrafted who showed a chimerism (donor cells) of greater than 50% in the first 30 days|30 days|Patients engrafted|||participants|||Number
1296829|NCT00060333|Secondary|Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory|Fatigue Assessment: A portion of the Brief Fatigue Inventory will be used to determine fatigue changes throughout the course of radiation. Patients will fill out the questionnaire at baseline, weekly during radiation, and 3 months after the beginning of radiation. Fatigue will be defined as: minor if the patient answers 0-3 (on a 10 point scale), mild for answers of 4-6, and severe for answers of 7-10. The percentage of patients that have worsened (improved) fatigue from baseline to the radiation stage will be calculated. We will also compare fatigue levels at baseline to the 3 month visit. Worsened fatigue is defined as going from minor to mild, minor to severe, or mild to severe. Improved fatigue is defined as going from severe to mild, severe to minor, or mild to minor.|Baseline to up to 3 months||||percentage of participants analyzed|||Number
1296830|NCT00060333|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. The number of participants reporting a grade 3 or higher toxicity are reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 5 years||||number of participants|||Number
1296831|NCT00060333|Secondary|Failure Time|Failure time is defined as the time from randomization to death due to any cause or disease progression. The median failure time will be estimated using the method of Kaplan-Meier.|Time from randomization to death due to any cause or disease progression (up to 5 years)||||||95% Confidence Interval|Median
1296832|NCT00060333|Secondary|Survival Time|Survival time: Survival time is defined as the time from randomization to death due to any cause. The median survival time will be estimated using the method of Kaplan-Meier.|up to 5 years||||||95% Confidence Interval|Median
1296833|NCT00060333|Secondary|Incidence of Regional and Systemic Metastases|Incidence of regional and systemic metastasis: Incidences will be calculated for each cohort and 95% confidence intervals will be constructed using the properties of the binomial distribution.|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
1296834|NCT00060333|Primary|2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence|The primary endpoint is the incidence of local recurrence within 2 years after treatment. Local recurrence (LR) is defined as a desmoplastic melanoma lesion recurring within the radiated field. The properties of the binomial distribution will be used to construct a 95% confidence interval for the true 2-year local recurrence rate (LRR). The Kaplan-Meier method will be used if some patients are lost to follow-up.|Within 2 years after treatment||||percentage of patients with LR||95% Confidence Interval|Number
1296835|NCT00060008|Primary|Tumor Progression as Measured by Tumor Area and Volume at 1 Year.|We correlated SUVmax and change in tumor volume over the subsequent year|One year||||percentage of change|Participants|Full Range|Median
1296836|NCT00059839|Primary|Event-free Survival (EFS)|Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level.|From first enrollment up to 3 years.|64 patients from Arm I were analyzed for this outcome measure, one patient was deemed ineligible. 61 patients from Arm II were analyzed for this outcome measure, three patients were deemed ineligible.|||percentage of participants||95% Confidence Interval|Number
1296837|NCT00059787|Secondary|To Determine the Tolerability of Twelve Months of Maintenance Treatment||Twelve months of maintenance||||participants|||Number
1296838|NCT00059787|Secondary|To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin||The duration of the study||||months||95% Confidence Interval|Median
1296839|NCT00059787|Secondary|To Measure EGFR Gene Amplification in Tumor Specimens||The duration of the study for up to 7 years|Tumor specimens were evaluated for EGFR gene amplification in 20 patients|||number of tumor specimens|||Number
1296840|NCT00059787|Primary|The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen|Adverse event assessment|For the duration of the study up to 7 years|Patients enrolled on all stratums included|||percentage of participants|||Number
1296841|NCT00059787|Primary|Pathologic Complete Response Rates|Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.|Up to 7 years|Patients who had optimally debulking surgery|||participants|||Number
1296842|NCT00059475|Primary|Response Rate|Response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR) (whichever is first) until the first date that recurrent disease is objectively documented. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|6 years|The number of participants analyzed and results are correct. We do not have the response rate data for all patients.|||participants|||Number
1296843|NCT00059475|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.|11 months||||Participants|||Number
1296844|NCT00059475|Primary|Immunologic Response Rate|Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.|11 months|The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.|||Participants|||Number
1296845|NCT00059332|Secondary|Mortality||3 months||||participants|||Number
1296846|NCT00059332|Secondary|Symptomatic Intracranial Hemorrhage||3 month||||participants|||Number
1296847|NCT00059332|Secondary|Serious Adverse Events||3 months||||participants|||Number
1296867|NCT00058825|Secondary|Time in Days to ANC Engraftment|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days||||days||Full Range|Median
1296848|NCT00059332|Secondary|Stroke Impact Scale|"The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.~Physical problems~Memory and thinking~Mood and emotions~Communication, reading and understanding~Daily activities~Mobility at home and in the community~Affected hand use~Hobbies and activities participation"|3 months||||units on a scale||Inter-Quartile Range|Median
1296849|NCT00059332|Secondary|Barthel Index|"The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are:~FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)"|3 months||||units on a scale||Inter-Quartile Range|Median
1296850|NCT00059332|Secondary|NIH Stroke Scale|"The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:~1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention"|3 months||||units on a scale||Inter-Quartile Range|Median
1296851|NCT00059332|Secondary|Modified Rankin Score ≤2|Functional independence based on modified Rankin score|3 months||||participants|||Number
1296852|NCT00059332|Secondary|Modified Rankin Score of 0 or 1|Minimal or no disability based on the modified Rankin score|3 months||||participants|||Number
1296853|NCT00059332|Primary|Modified Rankin Scale|"Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.~0 No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|3 months after stroke onset||||units on a scale||Inter-Quartile Range|Median
1296854|NCT00059215|Secondary|Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding or MACE.~Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.~Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL.~MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization"|randomization though 30 days after percutaneous coronary intervention (PCI)||||participants|||Number
1296855|NCT00059215|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.~A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin."|randomization though 30 days after percutaneous coronary intervention (PCI)||||participants|||Number
1296856|NCT00059215|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization.|randomization though 30 days after percutaneous coronary intervention (PCI)||||participants|||Number
1296857|NCT00059215|Primary|Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.~A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.~A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL."|randomization though 30 days after percutaneous coronary intervention (PCI)|Patients who received at least one dose of study drug|||participants|||Number
1296858|NCT00059228|Primary|Beck Depression Inventory|The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Higher total scores indicate more severe depressive symptoms. The range of scores vary from 0 to 63 (highest possible total) for the whole test. A score of 0 – 10 indicates minimal depression, while a score of over 40 indicates extreme depression. No subscales were used for this outcome.|Baseline|The analysis included only those subjects who had taken Estradiol and Placebo|||units on a scale||Standard Error|Mean
1296859|NCT00059228|Primary|Beck Depression Inventory|The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Higher total scores indicate more severe depressive symptoms. The range of scores vary from 0 to 63 (highest possible total) for the whole test. A score of 0 – 10 indicates minimal depression, while a score of over 40 indicates extreme depression. No subscales were used for this outcome.|6 weeks|The analysis included only those subjects who had taken Estradiol and Placebo|||Units on a scale||Standard Error|Least Squares Mean
1296860|NCT00058825|Secondary|Median Time to Engraftment With the Isolex/CLINIMACs System|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days||||days||Full Range|Median
1296861|NCT00058825|Secondary|Number of Patients Who Engrafted With the Isolex/CLINIMACs System|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days||||participants|||Number
1296862|NCT00058825|Secondary|2-year Overall Survival|Overall survival (OS) was calculated from the time of transplant to death from any cause or censored at last follow-up. Survival data were analyzed by Kaplan-Meier method.|2 years||||percentage of participants||95% Confidence Interval|Number
1296868|NCT00058825|Primary|Transplant Related Mortality (TRM)|Percentage of patients with transplant related mortality|100 days||||percentage of participants||97.5% Confidence Interval|Number
1296869|NCT00058552|Secondary|Kaplan Meier Estimate of Percentage of Participants Who Were Free of Disease Progression at 3, 6, and 12 Months|Per RECIST v 1.1, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|3, 6, and 12 months|Efficacy Analysis Population.|||percentage of participants|||Number
1296870|NCT00058552|Secondary|Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)|Efficacy Analysis Population. Seventeen participants in pertuzumab 420 mg arm and 33 participants in pertuzumab 1050 mg were censored for this analysis.|||weeks||95% Confidence Interval|Median
1296871|NCT00058552|Secondary|Percentage of Participants Who Died|The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)|Efficacy Analysis Population.|||percentage of participants|||Number
1296872|NCT00058552|Secondary|Duration of Response|Duration of response was defined as the time from the initial CR or PR to the time of disease progression.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Only responders (CR or PR) were included in the analysis.|||weeks||95% Confidence Interval|Median
1296873|NCT00058552|Secondary|Median Time of PFS|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.|||weeks||95% Confidence Interval|Median
1296874|NCT00058552|Secondary|Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.|||percentage of participants|||Number
1296875|NCT00058552|Primary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or Cancer Antigen 125 (CA-125) Changes|Response by tumor measurement occurred if there was documented and confirmed CR or PR determined by 2 consecutive investigator assessments that were at least 28 days apart. Response was assessed by either the RECIST v 1.1 or by CA-125 changes, based on measurable or non-measurable disease at baseline. Per RECIST v 1.1 (for measurable disease), CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Per CA-125 changes (for non-measurable disease), CR: decrease in the CA-125 to within the normal limits and less than (<) 40 international units per milliliter (IU/mL) and no clinical or radiological evidence of disease, PR: a greater than (>) 50 percent (%) decrease in CA-125 values from baseline, and no clinical or radiological evidence of new lesions.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population: All participants who received at least 1 dose of study drug and either underwent at least one postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.|||percentage of participants||95% Confidence Interval|Number
1296876|NCT00058539|Secondary|Serum Concentrations of Pertuzumab||Assessed at pre-dose, 15-minutes postdose on Day 1 (Cycle 1), Day 22 (Cycle 2), Day 43 (Cycle 3), Day 85 (Cycle 5), and Day 169 (Cycle 9); pre-dose on Day 253 (Cycle 13), and on Days 8, 15, 29 and 36|Pharmacokinetic evaluable participants|||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
1296877|NCT00058539|Secondary|Percentage of Participants Who Progressed at 3, 6 and 9 Months|Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of participants who were free from disease progression was calculated by subtracting the number of participants with disease progression at that time point from the total population at risk of disease progression, multiplied by 100.|3, 6, and 9 months|Efficacy analysis population|||percentage of participants|||Number
1296878|NCT00058539|Secondary|Duration of Response|Duration of response was defined as the time from the initial CR or PR to the time of disease progression.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|No participants experienced either CR or PR.||||||
1296879|NCT00058539|Secondary|Median Time of PFS|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population. Five participants were censored for this analysis.|||weeks||95% Confidence Interval|Median
1297051|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 88|Percentage of participants with Viral Load < 400 copies/mL|week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1296880|NCT00058539|Secondary|Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with an event divided by the number of participants analyzed, multiplied by 100.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population. Five participants were censored for this analysis.|||percentage of participants|||Number
1296881|NCT00058539|Primary|Kaplan Meier Estimate of Percentage of Participants With Disease Progression at 3 Months|Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions.|3 months|Efficacy analysis population.|||percentage of participants|||Number
1296882|NCT00058539|Primary|Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria|Response by tumor measurement occurred if there was documented and confirmed CR or PR. Response was assessed by both the RECIST and by PSA levels measurement, based on measurable or non-measurable disease at baseline. Per RECIST, CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A PSA response was defined as a PSA decline of greater than or equal to (≥) 50%, which had to be confirmed by a second PSA value at least 4 weeks later.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population: All participants who received at least 1 dose of study drug and either underwent at least 1 postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.|||percentage of participants||95% Confidence Interval|Number
1296883|NCT00058240|Secondary|Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 2 years||||patients|||Number
1296884|NCT00058240|Primary|Recommended Dose Level of Flavopiridol|Recommended dose determined by number of DLTs [non-hematologic toxicity grade 3 or greater (excluding not life-threatening transient liver function or transient electrolyte abnormalities, fatigue, or diarrhea resolving within 4 days), some grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity), hematologic toxicity of grade 4 thrombocytopenia/neutropenia persisting for 7 days or greater, or inability to continue cycle 2 by 7 weeks for reasons other than disease progression] and consideration of number of patients with severe tumor lysis requiring hemodialysis with dose 1.|Up to 6 weeks||||mg/m^2|||Number
1296885|NCT00058240|Primary|Number of Patients With Dose Limiting Toxicities (DLTs)|DLTs were defined as non-hematologic toxicity of grade 3 or greater severity (excluding transient liver function abnormalities, transient electrolyte abnormalities that are not life threatening, fatigue, or diarrhea that resolve within 4 days), or in some case grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity). Hematologic toxicity were evaluated by the modified NCI criteria and followed closely. Dose limiting only if grade 4 thrombocytopenia or neutropenia persists for 7 days or greater. Inability to continue with cycle 2 by 7 weeks for reasons other than progression of disease will also be considered a DLT.The National Cancer Institute Common Toxicity Criteria will be used to characterize toxicity.|up to 7 weeks||||patients|||Number
1296886|NCT00058214|Secondary|Time to Progression|Estimated using the product-limit method of Kaplan and Meier. Progression was defined as the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months.|From the date of registration to the date of documented PSA progression, assessed up to 6 years||||months||95% Confidence Interval|Median
1296887|NCT00058214|Primary|PSA Response|A PSA normalization (PSA-N) - was recorded on case report forms for any evaluation in which the PSA level was undetectable (< 0.1 ng/mL). If the PSA-N response was confirmed by a second measurement ≥ 4 weeks later, the patient’s best PSA response was considered PSA-N. PSA-PR was recorded if the PSA decreased by ≥ 50% from baseline (pretreatment) values and confirmed by a second measurement ≥ 4 weeks later. PSA-PD was recorded upon the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months. PSA-SD constituted responses that did not qualify for PSA-N, PSA-PR, or PSA-PD. Response = PSA-N + PSA-PR.|Up to 6 years||||percentage of participants|||Number
1296888|NCT00058123|Secondary|Overall Survival|based on date of study entry|2 years|Survival time was known for all 45 patients and 13 patients were censored as they were alive at last contact|||weeks||95% Confidence Interval|Median
1296889|NCT00058123|Secondary|Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas|Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0|2 years||||Participants|||Count of Participants
1296890|NCT00058123|Primary|Percentage of Participants With Progression Free Survival|Participants evaluated from date of study entry to the 6 month scan for progression|6 months||||percentage of participants|||Number
1296941|NCT00057330|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs have been tabulated for a 31-day period. An unsolicited AE was any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
1296891|NCT00058123|Primary|Proportion of Participants With Objective Response Rate (ORR)|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).~ORR = CR + PR"|2 years||||Participants|||Count of Participants
1296892|NCT00058058|Secondary|AUC to Determine the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast|Area Under the Curve (AUC) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as the Probability of malignancy from the initial MRI interpretation.|within 90 days of a negative mammogram of the study breast|All eligible participants with an analyzable MRI|||Participants|||Count of Participants
1296893|NCT00058058|Secondary|MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy|"Accuracy values (Sensitivity, Specificity, Positive Predicative Value (PPV), Negative Predictive Value (NPV), Diagnostic Yield, and Area Under the Curve (AUC)) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as either the Probability of malignancy from the initial MRI interpretation (for AUC) or the Final BI-RADs, where the final BI-RADS is defined as the BI-RADS assigned after all subsequent work-up and follow-up within 365 from the initial MRI are complete (an explicit recommendation for biopsy always results in a final BI-RADs of 4)."|within 90 days of a negative mammogram of the study breast|All eligible participants with an analyzable MRI|||Participants|||Count of Participants
1296894|NCT00058058|Primary|MRI Diagnostic Yield of Cancers in the Contralateral Breast|"To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.~the Test status was defined based on combinations of the following 4 factors:~The initial BI-RADs: from the MRI of the contralateral breast~The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4).~Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI~Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI"|within 90 days of a negative mammogram of the study breast|All eligible participants with an analyzable MRI|||Participants|||Count of Participants
1296895|NCT00058019|Secondary|Time to Progression|Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|up to 3 years||||Days||95% Confidence Interval|Median
1296896|NCT00058019|Secondary|Overall Survival|Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.|up to 3 years||||Days||95% Confidence Interval|Median
1296897|NCT00058019|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as >=50% decrease in the sum of the products of the greatest diameters; PD is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|up to 3 years||||Days||95% Confidence Interval|Median
1296898|NCT00058019|Primary|Safety and Toxicity of Ixabepilone|Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone.|up to 3 years||||participants|||Number
1296899|NCT00058019|Primary|Objective Overall Response Rate|The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.|up to 3 years||||participants|||Number
1296900|NCT00057954|Secondary|Progression-free Survival|Progression-free survival was defined as time from enrollment to disease progression or death from any cause, whichever occurred first. Patients who did not have progression-free survival events were censored at last date of disease assessment.|Assessed day 100 post transplant and every 3 months during year 1, every 6 months during years 2-3, then every 12 months during years 4-5 or through diagnosis of disease progression|all 6 enrolled patients|||days||95% Confidence Interval|Median
1296901|NCT00057954|Secondary|100-day Overall Survival|Proportion of patients who survived 100 days or more after enrolled on the study|Assessed at least twice a week for the first 60 days and weekly until day 100.|all 6 enrolled patients|||Proportion of participants||95% Confidence Interval|Number
1296902|NCT00057954|Primary|Proportion of Participants With Successful Engraftment||Assessed daily during inpatient stay|all enrolled 6 patients|||Proportion of participants||95% Confidence Interval|Number
1296903|NCT00057941|Primary|Clinical Benefit Rate|Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.|assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years|141 eligible and treated patients, 72 on Arm I (Anastrozole and ZD1839) and 69 on Arm II (Fulvestrant and ZD1839)|||percentage of participants||95% Confidence Interval|Number
1296904|NCT00057876|Secondary|Overall Response|Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis.|assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3|Eligible patients|||participants|||Number
1296905|NCT00057876|Secondary|Progression-free Survival Time|Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival.|assessed every 3 months for 2 years, then every 6 months for year 3|67 eligible patients with data on progression-free survival(PFS)|||Months||95% Confidence Interval|Median
1296906|NCT00057876|Primary|Overall Survival Time|Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.|assessed every 3 months for 2 years, then every 6 months for year 3|71 eligible patients|||Months||95% Confidence Interval|Median
1296907|NCT00057863|Secondary|Toxicities, Assessed and Graded According to CTCAE Version 3.0|Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities|Up to 7 years|There were 135 cycles administered.|||percentage of grade 3/4|||Number
1296908|NCT00057863|Secondary|Overall Survival|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until death, assessed up to 7 years||||weeks||95% Confidence Interval|Mean
1296909|NCT00057863|Secondary|Progression-free Survival|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until objective or symptomatic progression or death, assessed up to 7 years||||weeks||95% Confidence Interval|Mean
1296910|NCT00057863|Primary|Overall Objective Response Rate (CR+PR)|95% confidence interval will be estimated via binomial proportions.|Up to 7 years||||participants|||Number
1296911|NCT00057837|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death.|Assessed every 3 months for 2 years, then every 6 months for 1 years|Only eligible and treated patients are included in this analysis.|||Months||95% Confidence Interval|Median
1296912|NCT00057837|Secondary|Duration of Response|Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started.|Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.|Only eligible and treated patients with response are included in this analysis.|||Months||95% Confidence Interval|Median
1296913|NCT00057837|Primary|Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)|"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.|Only treated and eligible patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
1296914|NCT00057811|Primary|Toxic Death|Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.|Up to 1 year|Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.|||participants|||Number
1296915|NCT00057811|Primary|Minimal Residual Disease|The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).|Not Provided|Population analyzed included patients submitting samples for minimal disease assay at end induction|||percentage of samples analyzed||95% Confidence Interval|Number
1296929|NCT00023673|Primary|Percentage of Patients Who Survive at Least 12 Months|Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%.|From registration to 1 year|Eligible patients at the MTD dose level who started protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1296916|NCT00057811|Primary|Response Rate|Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present..|Up to 5 years|Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).|||percentage of participants analyzed||95% Confidence Interval|Number
1296917|NCT00057811|Primary|Grade ≥ 3 Stomatitis|The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences|Up to 1 year|Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.|||participants|||Number
1296918|NCT00057785|Secondary|Chemotherapy Compliance||From start of treatment to end of treatment|||||||
1296919|NCT00057785|Secondary|Other Acute and Late Toxicities||From start of treatment to last follow-up|||||||
1296920|NCT00057785|Secondary|Whole Mouth Saliva Output Relative to Pretreatment Measurements||From start of treatment to 1 year|||||||
1296921|NCT00057785|Secondary|Rate of Locoregional Control at 2 Years||From registration to 2 years|||||||
1296922|NCT00057785|Secondary|Rate of Xerostomia at 1 Year (Grade ≥ 2)||From start of treatment to 1 year|||||||
1296923|NCT00057785|Primary|Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered|Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.|From start of treatment to end of treatment|First 57 eligible patients who started study treatment.|||participants|||Number
1296924|NCT00057746|Primary|Incidence of Chronic Neurotoxicity|Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.|From study registration to one year.||||percentage of participants||95% Confidence Interval|Number
1296925|NCT00023673|Secondary|Number of Patients With Complete Response at 3 Months After Completion of Therapy|"Complete response means no evidence of tumor on the CT scan."|From start of treatment until 3 months after completion of all study treatment, estimated to be 5 or 6.5 months depending whether or not subject received optional adjuvant chemotherapy.|Eligible patients from Phase I and II 74 Gy arms who started study treatment.|||Participants|||Count of Participants
1296926|NCT00023673|Secondary|Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level)|Mean lung dose was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, mean lung dose, and mean esophageal dose were compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.|From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure|||Gy (mean dose)||Full Range|Mean
1296927|NCT00023673|Secondary|Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level)|Percent volume of total lung receiving > 20 Gy radiation therapy (Lung V20) was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, it was also compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.|From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure|||Percent (V20)||Full Range|Median
1296928|NCT00023673|Secondary|Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities.|Highest grade toxicity per subject was counted. Toxicities were graded using the Common Toxicity Criteria (CTC) v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.Chemotherapy/Acute RT toxicities occur during chemotherapy and/or within 90 days of the start of RT. Late RT toxicities occur more than 90 days after the start of RT.|Chemotherapy/Acute RT toxicity: from start of treatment to 90 days from start of study treatment; Late RT toxicity: from 90 days after start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|Eligible patients from Phase I and II 74 Gy arms who started study treatment. Additionally for late RT toxicity, those who have toxicity data at least 90 days from start of RT.|||Participants|||Count of Participants
1296930|NCT00023673|Primary|Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy|"Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on Radiation Therapy Oncology Group (RTOG) study 94-10. No acute (within 90 days from start of 3DRT) DLT's in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%.~Rating scale: 0 = not the MTD, 1 = MTD"|From start of treatment to 90 days|The first seven eligible patients who started protocol treatment at each dose level.|||units on a scale|||Number
1296931|NCT00057681|Secondary|K-SADS Mania Rating Scale|The K-SADS Mania Rating Scale (KMRS) is comprised of 15 items modified from WASH-U-KSADS items. The individual items are scored on a 1-6 severity scale and then these item scores are summed to create an overall KMRS score. Guidelines for interpretation are as follows: 0-11 = no or minimal mania, 12-17 = mild mania, 18-25 = moderate mania, 26+ = marked or worse mania. The maximum possible score is 64.|Measured at Week 8|KMRS data were analyzed for all subjects completing 8 weeks of the study.|||units on a scale||Standard Deviation|Mean
1296932|NCT00057681|Secondary|Modified Side Effects Form for Children and Adolescents|The Modified Side Effects Form for Children and Adolescents includes 62 potential side effects, with measures of frequency and severity for each item. Frequencies are 0=not present, 1=1-2 days, 2=3-4 days, 3=5-7 days. Severity scores are 0=not present, 1=mild (does not interfere with functioning), 2=moderate (some interference with functioning), 3=severe (functioning is significantly impaired because of side effects). Items for cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nose, genito urinary, dermatology, musculo-skeletal, and other side effects are included. For analyses, side effects that were reported at any frequency and a severity of 2 or greater were considered present.|Measured at Week 8|Modified Side Effects Form for Children and Adolescents data were analyzed for all subjects completing 8 weeks of the study.|||side effects at week 8||Standard Deviation|Mean
1296933|NCT00057681|Primary|Clinical Global Impressions-Bipolar Mania Improvement|The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Measured at Week 8|CGI-BP mania improvement data were analyzed for all subjects completing 8 weeks of the study.|||units on a scale||Standard Deviation|Mean
1296934|NCT00057577|Other Pre-specified|Serious Adverse Events|Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study|Throughout study, up to 54 months||||number of SAE's|||Number
1296935|NCT00057577|Primary|Number of Participants in Recurrence According to the LIFE and HRSD|Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)|Measured up to Month 36 from recovery||||Participants|||Count of Participants
1296936|NCT00057577|Primary|Number of Participants in Recovery According to the LIFE and HRSD|Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)|Through 36 months of treatment||||number participants that reach recovery|||Number
1296937|NCT00057577|Primary|Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)|Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)|Through month 18 of treatment||||number participants that reach remission|||Number
1296938|NCT00057551|Primary|Remission|Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits|12 weeks|Refers to # of subjects who completed 12 weeks of treatment|||percentage of participants|||Number
1296939|NCT00057330|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in a subject’s offspring.|Throughout the study (From Month 0 up to Month 20)|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
1296940|NCT00057330|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)|NOCDs included adverse events (AEs) as autoimmune disorders, asthma, type I diabetes, allergies. MSCs included AEs prompting emergency room or physician visits unrelated to common diseases or routine visits for physical examination or vaccination, or SAEs unrelated to common diseases. SAEs included medical occurrences either life-threatening, requiring hospitalization, or resulting in death, disability/incapacity or congenital anomaly/birth defect in a subject’s offspring. Common diseases included upper respiratory infections (URIs), sinusitis, pharyngitis, gastroenteritis, urinary tract infection, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. The following were not reported if not considered as SAEs and occurring more than 30 days post vaccination: URIs, sinusitis, pharyngitis, gastroenteritis, injury, or visits for routine physical examination or vaccination. AEs are described, using Medical Dictionary for Regulatory Activities’ preferred terms.|Throughout the study (From Month 0 up to Month 20)|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
1296952|NCT00056862|Secondary|Slope of Second Phase Decline in HCV Levels|The 2nd phase slope is defined as the slope of the logarithmic viral levels from week 1 to week 4 of treatment (see Neumann et al, Science, 1998).|day 7 to day 28||||logIU/mL||Standard Deviation|Mean
1297052|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 80|Percentage of participants with Viral Load < 400 copies/mL|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1296942|NCT00057330|Secondary|Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed were fatigue, headache, malaise and fever (oral/axillary/tympanic).~Grade 3 headache, fatigue, malaise = symptom that prevented normal activities.~Grade 3 fever = temperature above 39.0 degrees Celsius.~Related = symptom assessed by the investigator as causally related to the vaccination"|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
1296943|NCT00057330|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed were pain, redness and swelling.~Grade 3 pain = pain that prevented normal activities.~Grade 3 redness/swelling = redness/swelling above 30 mm and persisting for more than 24 hours"|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
1296944|NCT00057330|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed were pain, redness and swelling.~Solicited general symptoms assessed were fatigue, headache, malaise and fever (defined as oral/axillary/tympanic temperature equal to or above 37.5 degrees Celsius)."|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
1296945|NCT00057330|Secondary|Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.|Titers for Anti-HSV neutralizing antibodies are presented as Geometric Mean Titers (GMTs), and are expressed in Estimated Doses (ED), that is, the reciprocal of the dilution necessary to achieve neutralization. Antibody titers below the lowest level of quantification were not calculated .|At Months 0, 2, 6, 7, 12, 16 and 20|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.|||ED||95% Confidence Interval|Geometric Mean
1296946|NCT00057330|Secondary|Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL). The seroprotection cut-off of the assay was 40 EU/mL|At Months 0, 2, 6, 7, 12, 16 and 20|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
1296947|NCT00057330|Secondary|Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion|The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 7 and 20|The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.|||Subjects|||Number
1296948|NCT00057330|Secondary|Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion.|The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 2 and 20|The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.|||Subjects|||Number
1296949|NCT00057330|Secondary|Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2|Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 7 and 20|The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.|||Subjects|||Number
1296950|NCT00057330|Primary|Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2|Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 2 and 20|The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.|||Subjects|||Number
1296951|NCT00056862|Secondary|Time to Negativity|Time from treatment initiation to the first negative HCV RNA test during treatment|24 weeks||||days||95% Confidence Interval|Median
1296953|NCT00056862|Primary|Virological Response Category (Per Protocol)|Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.|6 months after therapy|Per protocol|||participants|||Number
1296954|NCT00056862|Secondary|First Phase Decline in Logarithm of HCV RNA Level|The 1st phase decline is defined as the log difference between baseline HCV RNA level and the level on day 2 of treatment (see Neumann et al, Science, 1998).|2 days||||logIU/mL||Standard Deviation|Mean
1296955|NCT00056862|Primary|Virological Response (Intention to Treat)|Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.|6 months after stopping therapy|Intention-to-treat|||participants|||Number
1296956|NCT00056563|Secondary|The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation|Unified Parkinson’s Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher score indicates that the condition is worse.|at six months||||units||95% Confidence Interval|Mean
1296957|NCT00056563|Primary|The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline.||at six months||||Hours per day||95% Confidence Interval|Mean
1296958|NCT00056550|Secondary|Local Assessment of Thromboembolism by Physical Examination.|The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.|30 days after last dose|14 patients were included in the trial and treated with rhAT.|||Participants in study|||Number
1296959|NCT00056550|Primary|Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).|Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).|Baseline, last day of dosing and day 7 (+ or - 1 day)|14 patients who received at least 1 dose of rhAT were included in the Safety population. During the central review of the duplex ultrasound, 1 delivery patient was diagnosed with a DVT at baseline, and was not evaluable for efficacy, the patient was excluded from the PP population.|||participants|||Number
1296960|NCT00056498|Secondary|Negative Symptom Total Score by Week and Treatment Group|The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change.|Baseline and every two weeks for 16 weeks.|The intent to treat analysis included all participants who received at least one dose of study medication and completed the SANS rating at the specified treatment week.|||units on a scale||Standard Deviation|Mean
1296961|NCT00056498|Secondary|Neuropsychological Testing - Overall Composite Z-score|The neuropsychological testing measured attention, executive function/problem solving, motor speed, processing speed/response generation, and verbal, visual, and working memory. The individual test raw scores were converted to z-scores and an overall composite z-score was computed from the average of the individual test z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance.|Baseline and Week 16|Two participants completed 9 or fewer of the 13 individual tests in the neurocognitive battery, and were omitted from calculation of the overall composite score|||z-score||Standard Deviation|Mean
1296962|NCT00056498|Primary|Positive Symptom Item Scores by Week and Treatment Group|"The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change."|Baseline and every two weeks for 16 weeks.|The intent to treat analysis included all participants who received at least one dose of study medication and completed the BPRS rating at the specified week.|||units on a scale||Standard Deviation|Mean
1296963|NCT00056472|Other Pre-specified|Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.|The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression.|Weeks 1 to 12||||Scores on Ham-D||Standard Error|Mean
1296964|NCT00056472|Secondary|Scores on CGI-S Compared to Baseline Over the Course of the Trial|A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient.|Weeks 1 to 12||||units on CGI scale||Standard Error|Mean
1297053|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 72|Percentage of participants with Viral Load < 400 copies/mL|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1296965|NCT00056472|Primary|Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial|"Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval.~Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior."|Weeks 1 to 12||||participants|||Number
1296966|NCT00056407|Secondary|Mean Change From Baseline in Testosterone at Month 48|Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.|||percent change||Standard Deviation|Mean
1296967|NCT00056407|Secondary|Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48|Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter.|Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||participants|||Number
1296968|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48|The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||points on a scale||Standard Error|Mean
1296969|NCT00056407|Secondary|Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48|The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||points on a scale||Standard Error|Mean
1296970|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48|The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.|||points on a scale||Standard Error|Mean
1296971|NCT00056407|Secondary|Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48|The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.|||points on a scale||Standard Error|Mean
1296972|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48|The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.|||points on a scale||Standard Error|Mean
1296973|NCT00056407|Secondary|Overall Survival|Overall survival is assessed as the number of deaths reported throughout the study.|From time informed consent is signed to 4-month Safety Follow-Up period|Efficacy Population|||number of deaths|||Number
1296974|NCT00056407|Secondary|Number of Participants With Post-biopsy Macroscopic Hematospermia|Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.|Baseline through Year 4|Efficacy Population|||participants|||Number
1296975|NCT00056407|Secondary|Number of Participants With Post-biopsy Macroscopic Hematuria|Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.|Baseline to Year 4|Efficacy Population|||participants|||Number
1296976|NCT00056407|Secondary|Number of Participants With at Least One Urinary Tract Infection (UTI)|A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population|||participants|||Number
1296977|NCT00056407|Secondary|Number of Participants With at Least One Event of Acute Urinary Retention (AUR)|A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study.|Years 1-2 and Overall (Years 1-4)|Efficacy Population|||participants|||Number
1296979|NCT00056407|Secondary|Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48|Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers.|Baseline and Months 12, 24, 36, and 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||milliliters/second||Standard Error|Mean
1296980|NCT00056407|Secondary|Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48|Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value).|Baseline, Month 24, and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||percent change||Standard Error|Mean
1296981|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48|The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline to Year 4 (Month 48)|Efficacy Population, last observation carried forward (LOCF). In the LOCF approach, missing values at post-baseline assessments are replaced with the participant's previous non-missing post-baseline assessment. The number analyzed is smaller than the total number in the population due to missing values.|||points on a scale||Standard Error|Mean
1296982|NCT00056407|Secondary|Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment|The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy).|Baseline to Year 4|Efficacy Population|||participants|||Number
1296983|NCT00056407|Secondary|Treatment Alteration Score|The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes.|Baseline to Year 4|Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||points on a scale||Standard Deviation|Mean
1296984|NCT00056407|Secondary|Number of Cancer-positive Cores|The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant.|Baseline to Year 4|Prostate Cancer Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||number of cores||Standard Deviation|Mean
1296985|NCT00056407|Secondary|Percentage of Core Involved at Diagnosis|The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample.|Baseline to Year 4|Prostate Cancer Population: all participants in the Efficacy Population who received a post-baseline diagnosis of prostate cancer by the central pathology laboratory. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||percentage of core||Standard Deviation|Mean
1296986|NCT00056407|Secondary|Volume of HGPIN at Biopsy|The amount of prostate biopsy tissue with HGPIN was measured.|Baseline to Year 4|Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||cc*10^-3 (microliter)||Standard Deviation|Mean
1296987|NCT00056407|Secondary|Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy|"The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category (HGPIN or prostate cancer diagnosis) and again in the last category (HGPIN, ASAP, or prostate cancer diagnosis)."|Baseline to Year 4|Biopsied Population: the number analyzed is the total number in the population|||participants|||Number
1296988|NCT00056407|Secondary|Number of Participants With the Indicated Gleason Score at Diagnosis|Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10.|Baseline to Year 4|Biopsied Population: all randomized participants with a negative entry biopsy who received at least 1 dose of study treatment and who had at least 1 biopsy reviewed by the central pathology lab. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||participants|||Number
1296999|NCT00056160|Primary|Time to Tumor Progression (TTP)|Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.|60 weeks (median Time To Progression of CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.|||Weeks||95% Confidence Interval|Median
1297000|NCT00055692|Other Pre-specified|Disease Stability||At 6 months|||||||
1296989|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)|Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population, restricted crude rate: the number of prostate cancer events is based on the the number of participants who had at least one biopsy during the time period. Ns at Years 1-2 and Years 3-4 are the number who had a biopsy in those time periods; the overall n is the number of participants who had 1 or more biopsy during Years 1-4.|||participants|||Number
1296990|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)|Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population, modified crude rate: participants who either were diagnosed with prostate cancer during the study or had an end of time period biopsy. N for each time period is the number who either had at least 1 biopsy in the final 6 months of the time period or had a positive biopsy anytime during the time period.|||participants|||Number
1296991|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)|Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia[HGPIN] or typical small acinar proliferation [ASAP]) and prostate surgeries were reviewed by the lead pathologist.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population: all randomized participants with a negative entry biopsy, as determined by the CPL, who received at least 1 dose of study drug. The crude rate approach included all participants at risk at the beginning of each time period .|||participants|||Number
1296992|NCT00056316|Secondary|Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)|"10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = very slightly or not at all, and 5 = extremely. The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion."|Post-intervention, assessed 4-14 days after final intervention session.|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.|||Points on a scale||Standard Deviation|Mean
1296993|NCT00056316|Primary|Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)|21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.|Post-intervention, assessed 4-14 days after final intervention session.|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.|||Points on a scale||Standard Deviation|Mean
1296994|NCT00056316|Secondary|Negative Affect Schedule (Watson, Clark & Tellegen, 1988)|"10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = very slightly or not at all, and 5 = extremely. The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion."|Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.|||Points on a scale||Standard Deviation|Mean
1296995|NCT00056316|Primary|Beck Depression Inventory II (Beck, Steer & Brown, 1996)|21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.|Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention|All randomized participants|||Points on a scale||Standard Deviation|Mean
1296996|NCT00056160|Secondary|Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)|The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.|30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.|||Weeks||Standard Deviation|Mean
1296997|NCT00056160|Secondary|Myeloma Response|The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.|Up to Unblinding (07 Jun 2005)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.|||Participants|||Number
1296998|NCT00056160|Secondary|Overall Survival|Overall survival was calculated as the time from randomization to death from any cause.|170 weeks (median overall survival of CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.|||Weeks||95% Confidence Interval|Median
1297003|NCT00055692|Primary|Mean Arterial Enhancement, Per Lesion, as Determined by Dynamic Gadolinium-enhanced Magnetic Resonance Imaging (MRI), Before and Following Bevacizumab Therapy.||Baseline and 8 weeks after bevacizumab therapy|Eight consecutive patients enrolled at one site were evaluated before and at 8 weeks after bevacizumab therapy with DCE-MRI.|||relative MR units||Standard Deviation|Mean
1297004|NCT00055692|Primary|Disease Response|MRI scan is required at weeks 8, 16 and then every 12 weeks until disease progression. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|MRI is required at weeks 8, 16 and then every 12 weeks until disease progression||||participants||95% Confidence Interval|Number
1297005|NCT00055692|Primary|Progression-free Survival||At 6 months||||percentage of participants||95% Confidence Interval|Number
1297006|NCT00055601|Secondary|Bladder-intact Survival Rate (5 Years)|Bladder-intact survival was measured from the date of randomization to occurrence of cystectomy or death. Five-year rates were estimated using the Kaplan-Meier method.|From the date of randomization to five years.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1297007|NCT00055601|Secondary|Complete Response After Induction|Complete response requires the absence of any tumor in the tumor-site biopsy specimen or elsewhere and a bimanual exam that does not indicate the presence of a tumor mass.|From randomization to eight weeks|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1297008|NCT00055601|Primary|Treatment Completion Rate|Radiation therapy and chemotherapy per protocol or within acceptable variation guidelines based on central review. The study was designed for a two-sided binomial test with 87% power and a significance level of 0.05 with a null hypothesis of a 70% completion rate against the alternative 90% completion rate. For each arm, more than 34 out of 43 evaluable patients completing the treatment, would indicate to reject the null hypothesis for a better treatment completion rate. Fewer than 24 out 43 evaluable patients completing the treatment would indicate to reject the null hypothesis for a worse treatment completion rate. Otherwise, the conclusion would be that there is not enough evidence to reject the null hypothesis of a 70% completion rate in either direction.|From randomization to 11 weeks|All eligible patients who started study treatment.|||percentage of participants||95% Confidence Interval|Number
1297009|NCT00055497|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality on the item (e.g., feeling of fatigue none of the time). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life."|Change from Baseline of lead-in study to Week 24 and Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. OL adalimumab group was all participants assigned to the OL treatment who continued past Week 4. LOCF was used for missing data. 4 participants in OL group did not have IBDQ data at Baseline of lead-in study.|||Scores on a scale||95% Confidence Interval|Mean
1297010|NCT00055497|Secondary|Number of Participants Achieving CR-70 - LOCF|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF imputation was used for missing data.|||Participants|||Number
1297011|NCT00055497|Secondary|Number of Participants Achieving CR-100 - LOCF|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF was used for missing data.|||Participants|||Number
1297012|NCT00055497|Secondary|Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56||||Participants|||Number
1297013|NCT00055497|Secondary|Number of Participants Achieving Clinical Remission at Week 24 - LOCF|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 24|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Last observation carried forward (LOCF) was used for missing data.|||Participants|||Number
1297026|NCT00055471|Primary|Dose Limiting Toxicities (DLTs)|"DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment.~The numbers of patients with a DLT are reported."|Baseline to Day 29.||||Participants|||Number
1297014|NCT00055497|Secondary|Number of Participants Achieving Clinical Response 70 (CR-70)- NRI|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and to Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-70 not achieved) was used for missing data.|||Participants|||Number
1297015|NCT00055497|Secondary|Number of Participants Achieving Clinical Response 100 (CR-100) - NRI|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.|||Participants|||Number
1297016|NCT00055497|Primary|Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Last observation carried forward was used for missing data.|||Participants|||Number
1297017|NCT00055497|Primary|Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.|||Participants|||Number
1297018|NCT00055497|Secondary|Number of OL Participants Achieving Clinical Remission at Week 56 - NRI|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.|||Participants|||Number
1297019|NCT00055497|Secondary|Number of Participants Achieving Clinical Remission at Week 24 - NRI|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 24|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.|||Participants|||Number
1297020|NCT00055471|Secondary|Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)|Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
1297021|NCT00055471|Secondary|Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)|Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
1297022|NCT00055471|Secondary|Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)|"Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).~Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100"|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
1297023|NCT00055471|Secondary|Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)|Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
1297024|NCT00055471|Secondary|Change in Total Prostate Specific Antigen (PSA)|"Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).~Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100"|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
1297027|NCT00055237|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|70 months|"All adverse events regardless of attribution, over 202 cycles in 19 patients. Per protocol analysis of adverse events.~Cohort 1 and 2 are reported together."|||Participants|||Count of Participants
1297028|NCT00055237|Primary|Response Rate|Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.|36 months|Cohort 2 is not reported here because response rate in HIV negative patients was a secondary outcome.|||Percentage of participants||95% Confidence Interval|Mean
1297029|NCT00054847|Secondary|Stroke||Within 1 year of bypass surgery||||participants|||Number
1297030|NCT00054847|Secondary|Myocardial Infarction||Within 1 year of bypass surgery||||participants|||Number
1297031|NCT00054847|Secondary|Death||Within 1 year of surgery.||||participants|||Number
1297032|NCT00054847|Primary|To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.|The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.|1 year|All analyses were performed according to intention to treat. The study was designed to have 90%power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5% and an expected 1-year catheterization completion rate of 65%. .|||grafts|Participants||Number
1297033|NCT00054756|Primary|TSH Response to TRH|Serum TSH Levels in Response to TRH Administration|180 minutes from infusion|2 participants did not have results drawn at 180 minutes|||mcIU/mL||Full Range|Mean
1297034|NCT00054717|Secondary|Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities|NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|240 Weeks|Safety Analysis Set with On-Treatment data (SAF-OT), all patients treated with at least one dose of study drug and have on-treatment laboratory values|||Percentage of participants|||Number
1297035|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 96|Percentage of participants with Viral Load < 50 copies/mL|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297036|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 88|Percentage of participants with Viral Load < 50 copies/mL|Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297037|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 80|Percentage of participants with Viral Load < 50 copies/mL|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297038|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 72|Percentage of participants with Viral Load < 50 copies/mL|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297039|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 64|Percentage of participants with Viral Load < 50 copies/mL|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297040|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 56|Percentage of participants with Viral Load < 50 copies/mL|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297041|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 48|Percentage of participants with Viral Load < 50 copies/mL|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297042|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 40|Percentage of participants with Viral Load < 50 copies/mL|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297043|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 32|Percentage of participants with Viral Load < 50 copies/mL|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297044|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 24|Percentage of participants with Viral Load < 50 copies/mL|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297045|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 16|Percentage of participants with Viral Load < 50 copies/mL|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297046|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 8|Percentage of participants with Viral Load < 50 copies/mL|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297047|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 4|Percentage of participants with Viral Load < 50 copies/mL|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297056|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 48|Percentage of participants with Viral Load < 400 copies/mL|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297057|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 40|Percentage of participants with Viral Load < 400 copies/mL|Week 40||||Percentage of participants|||Number
1297058|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 32|Percentage of participants with Viral Load < 400 copies/mL|week 32||||Percentage of participants|||Number
1297059|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 24|Percentage of participants with Viral Load < 400 copies/mL|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297060|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 16|Percentage of participants with Viral Load < 400 copies/mL|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297061|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 8|Percentage of participants with Viral Load < 400 copies/mL|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297062|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 4|Percentage of participants with Viral Load < 400 copies/mL|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297063|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 2|Percentage of participants with Viral Load < 400 copies/mL|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297064|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load < 400 copies/mL|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297065|NCT00054717|Secondary|Time to New CDC Class C Progression Event or Death.|Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death|after 48 weeks of treatment|Safety Analysis Set (SAF), includes all patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1297066|NCT00054717|Secondary|Mean Change From Baseline to Week 96 in CD4+ Cell Count||Baseline to Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297067|NCT00054717|Secondary|Mean Change From Baseline to Week 88 in CD4+ Cell Count||Baseline to Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297068|NCT00054717|Secondary|Mean Change From Baseline to Week 80 in CD4+ Cell Count||Baseline to Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297069|NCT00054717|Secondary|Mean Change From Baseline to Week 72 in CD4+ Cell Count||Baseline to Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297070|NCT00054717|Secondary|Mean Change From Baseline to Week 64 in CD4+ Cell Count||Baseline to Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297071|NCT00054717|Secondary|Mean Change From Baseline to Week 56 in CD4+ Cell Count||Baseline to Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297072|NCT00054717|Secondary|Mean Change From Baseline to Week 48 in CD4+ Cell Count||Baseline to Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297073|NCT00054717|Secondary|Mean Change From Baseline to Week 40 in CD4+ Cell Count||Baseline to Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297074|NCT00054717|Secondary|Mean Change From Baseline to Week 32 in CD4+ Cell Count||Baseline to Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297075|NCT00054717|Secondary|Mean Change From Baseline to Week 24 in CD4+ Cell Count||Baseline to Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297076|NCT00054717|Secondary|Mean Change From Baseline to Week 16 in CD4+ Cell Count||Baseline to Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297077|NCT00054717|Secondary|Mean Change From Baseline to Week 8 in CD4+ Cell Count||Baseline to Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297078|NCT00054717|Secondary|Mean Change From Baseline to Week 4 in CD4+ Cell Count||Baseline to Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297079|NCT00054717|Secondary|Mean Change From Baseline to Week 2 in CD4+ Cell Count||Baseline to Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
1297080|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 96||Baseline to Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1297081|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 88||Baseline to Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1297082|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 80||Baseline to Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
1297094|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 64|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297095|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 56|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297096|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 48|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297097|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 40|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297098|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 32|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297099|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 24|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297100|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 16|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297101|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 8|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297102|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 4|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297103|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 2|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297104|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297105|NCT00054717|Secondary|Time to Confirmed Virologic Failure Through 96 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1297106|NCT00054717|Secondary|Time to Confirmed Virologic Failure Through 48 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1297107|NCT00054717|Secondary|Time to Treatment Failure Through 96 Weeks of Treatment|time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1297108|NCT00054717|Secondary|Treatment Response at Week 96|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297109|NCT00054717|Secondary|Treatment Response at Week 88|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297110|NCT00054717|Secondary|Treatment Response at Week 80|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297111|NCT00054717|Secondary|Treatment Response at Week 72|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297112|NCT00054717|Secondary|Treatment Response at Week 64|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297273|NCT00047385|Secondary|Lung Cancer Diagnoses|Lung cancer diagnoses confirmed by medical record abstraction.|All events through December 31, 2009; median follow-up 6.5 years|All participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1297113|NCT00054717|Secondary|Treatment Response at Week 56|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297114|NCT00054717|Secondary|Treatment Response at Week 48|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297115|NCT00054717|Secondary|Treatment Response at Week 40|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297116|NCT00054717|Secondary|Treatment Response at Week 32|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297117|NCT00054717|Secondary|Treatment Response at Week 24|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297118|NCT00054717|Secondary|Treatment Response at Week 16|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297119|NCT00054717|Secondary|Treatment Response at Week 8|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
1297120|NCT00054717|Secondary|Treatment Response at Week 4|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297121|NCT00054717|Secondary|Treatment Response at Week 2|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297122|NCT00054717|Secondary|Treatment Response at Week 24|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297123|NCT00054717|Primary|Time to Treatment Failure Through 48 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
1297124|NCT00054717|Primary|Treatment Response at Week 48|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|At week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
1297125|NCT00054704|Primary|Montgomery-Asberg Depression Rating Scale|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of depression symptoms. Patients were rated weekly on 10 symptoms on a scale of 0 to 6 for each item, where 0 indicated no symptoms and 6 indicated the highest severity of that symptom. Total scores range from 0 to 60, where a moderate severity of depression would be present with a score of at least 20.|8 weeks|Data from all patients were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1297126|NCT00054691|Secondary|Duration of Response|Response duration was defined as the time from initial response during therapy to progression of disease.|Every 8 weeks till disease progression.|Out of 40 participants, 19 participants had progressive disease, 2 participants had unmeasurable disease and 1 participant was noncompliant.|||months||Full Range|Median
1297127|NCT00054691|Primary|Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)|Responses were assessed according to the Union Internationale Contre le Cancer (UICC) / World Health Organization (WHO) criteria. Objective response (measurable response) defined as: Partial response (PR): Applies only to participants with at least 1 measurable lesion; >/=50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. Stable Disease (SD): No progression of evaluable disease and/or no new lesions. Progressive Disease (PD): 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease.|Every 8 weeks till disease progression.|Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant.|||participants|||Number
1297128|NCT00054665|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|43 months||||Participants|||Number
1297150|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Tumor Protein p53 (p53)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297129|NCT00054665|Primary|Clinical Response Rate|Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease|18 weeks||||Participants|||Number
1297130|NCT00054639|Primary|Number of Patients With Objective Response|Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment|2 months following study treatment|Analysis was per protocol. Of the 48 participants enrolled, only 42 were evaluable for response.|||participants|||Number
1297131|NCT00054353|Secondary|Response Rate|Number of subjects who achieved CR post-transplant. Response rate will be summarized using cumulative incidence estimates.|Up to 5 years||||Participants|||Count of Participants
1297132|NCT00054353|Secondary|Relapse Rate|Number of subjects who relapsed after achieving CR post-transplant. Relapse rate will be summarized using cumulative incidence estimates.|Up to 5 years||||Participants|||Count of Participants
1297133|NCT00054353|Secondary|Engraftment|Number of subjects who engrafted post-transplant. Engraftment will be monitored in a sequential fashion.|Up to 5 years||||Participants|||Count of Participants
1297134|NCT00054353|Secondary|OS|Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.|At 6 months and then every year thereafter, up to 5 years||||Participants|||Count of Participants
1297135|NCT00054353|Primary|Incidence of Chronic (Extensive) GVHD|Number of subjects with chronic extensive GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.|Up to 5 years||||Participants|||Count of Participants
1297136|NCT00054353|Primary|Incidence of Acute GVHD (Grades III-IV)|Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.|Up to 5 years||||Participants|||Count of Participants
1297137|NCT00054353|Primary|Non-relapse Mortality|Early NRM will be monitored in a sequential fashion.|At day 100||||Participants|||Count of Participants
1297138|NCT00054353|Primary|PFS|PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas.|At 1 year post-transplant|There were 4 patients who, although they did not have progression/relapse, died before the 1 year mark, and thus are not included in the 1 year PFS count.|||Participants|||Count of Participants
1297139|NCT00054327|Post-Hoc|Number of Patients With Overall Survival at 2 Years.||at 2 years from transplant||||participants|||Number
1297140|NCT00054327|Secondary|Toxicity as Measured by CTC v2.0|Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.|at 100 days post transplant||||participants|||Number
1297141|NCT00054327|Secondary|Incidence of Recurrent Disease|Number of patients that have disease recurrence.|at day 100 post transplant||||participants|||Number
1297142|NCT00054327|Secondary|Graft-versus-host Disease (GVHD)|Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe.|at 100 days post transplant||||participants|||Number
1297143|NCT00054327|Primary|Rates of Durable Engraftment|Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC >500/µl and platelets >20K/µl without transfusion support.|at day 42||||days||Standard Deviation|Mean
1297144|NCT00054275|Secondary|Overall Survival as of 2008|Overall survival (OS) was defined as time from the start of treatment to death, and censored at the time of last assessment for survivors.|5 yrs|Including 10 patients with only 1 cycle of treatment|||months||95% Confidence Interval|Median
1297145|NCT00054275|Secondary|Progression Free Survival(PFS)|Progression free survival was defined as time from the start of treatment to the date of cancer progression, or death, and censored at the date of last follow-up for those without disease progression and still alive. Stable disease is measured from the start of the treatment until progression, taking as reference the smallest measurements recorded since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|3 years||||months||95% Confidence Interval|Median
1297146|NCT00054275|Primary|Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000|Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.|after 6 course (6 months) of combination therapy|Excluding 11 not evaluable cases|||participants|||Number
1297147|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGFR-2|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297148|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGF Receptor (VEGFR)-1|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297149|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGF|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297151|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Phosphorylated-v-akt Murine Thymoma Viral Oncogene Homolog 1 (Akt)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297152|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Phosphorylated-mitogen-activated Protein Kinase (MAP) Kinase|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297153|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for p27|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297154|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Marker of Proliferation Ki-67 (Ki-67)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297155|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Human Epidermal Growth Factor Receptor 3 (HER3)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297156|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for EGFR|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
1297157|NCT00054132|Other Pre-specified|HER2 Status|Associations between response and HER2 will be assessed by Fisher's exact test.|Up to 12 years|||||||
1297158|NCT00054132|Secondary|Participants With Duration of Stable Disease Greater Than or Equal to 6 Months|Duration of stable disease greater than or equal to 6 months|From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years||||Participants|||Count of Participants
1297159|NCT00054132|Secondary|Number of Patients Evaluated for Toxicity|graded according to the National Cancer Institute Common Toxicity Criteria version 4.0|up to 12 years|Please see adverse events section.|||Participants|||Count of Participants
1297160|NCT00054132|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years||||weeks||95% Confidence Interval|Median
1297161|NCT00054132|Secondary|Duration of Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).Evaluation of Target Lesions Complete Response (CR):Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|From the time measurement criteria are met for CR and PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years||||months|||Number
1297162|NCT00054132|Primary|Response Rate, Defined as Complete Response (CR) + Partial Response (PR), Using the Response Evaluation Criteria in Solid Tumors|Estimated at the end of the trial. Complete Response (CR):Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD 55 Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|Up to 12 years||||participants|||Number
1297163|NCT00054132|Primary|Level of EGFR Expression|"Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity)~1+ - 3+ = positive:~faint immunoreactivity (weak staining)~intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics."|Up to 12 years||||participants|||Number
1297164|NCT00054028|Secondary|Response as Measured by RECIST Criteria|Evaluation of secondary endpoints will be primarily descriptive. Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Response rates will include 95% confidence limits.|Up to 5 years|Objective Response Rate|||percentage of patients|||Number
1297165|NCT00054028|Primary|Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) for target lesion s and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Up to 8 weeks||||patients|||Number
1297166|NCT00054028|Primary|Percentage of Patients That Achieved Target Suramin Concentrations in Plasma|Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.|Up to 5 years||||percent of patients|||Number
1297167|NCT00053898|Secondary|Quality-adjusted Survival Time|The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method.|10 years||||months||95% Confidence Interval|Mean
1297168|NCT00053898|Secondary|Quality of Life-Short Form 12 (SF-12) Physical Health Component Score|The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0–100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health.|5 years|The Quality of Life study was performed in a subset of B-35 participants. Participants were required to have submitted a baseline and at least one follow-up QOL form to be included in the analysis.|||units on a scale||Standard Deviation|Mean
1297169|NCT00053898|Secondary|Percentage of Patients Alive (Overall Survival)|Percentage of patients alive.|10 years|The analysis for overall survival included those whose method of contact for follow-up was by telephone.|||percentage of participants event-free|||Number
1297170|NCT00053898|Secondary|Percentage of Patients Alive and Disease-free|Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer.|10 years||||percentage of participants event-free|||Number
1297171|NCT00053898|Secondary|Percentage of Patients Free From Osteoporotic Fractures|Percentage of patients free from fractures of the hip, spine, and wrist.|10 years|The analysis for osteoporotic fractures included those whose method of contact for follow-up was by telephone. Two participants were excluded from the analysis because their date of fracture was unknown.|||percentage of participants event-free|||Number
1297172|NCT00053898|Secondary|Percentage of Patients Free From Non-breast Secondary Cancer|Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event.|10 years||||percentage of participants event-free|||Number
1297173|NCT00053898|Secondary|Percentage of Patients Free From Contralateral Breast Cancer|Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event.|10 years||||percentage of participants event-free|||Number
1297174|NCT00053898|Secondary|Percentage of Patients Free From Ipsilateral Recurrence|Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event.|10 years||||percentage of participants event-free|||Number
1297175|NCT00053898|Secondary|Percentage of Patients Free From Invasive Breast Cancer|Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers.|10 years||||percentage of participants event-free|||Number
1297176|NCT00053898|Primary|Percentage of Patients Free From Breast Cancer|Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.|10 years||||percentage of participants event-free|||Number
1297177|NCT00053846|Primary|Dyspnea as Measured by Oxygen Cost Diagram (OCD)|OCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea.|28 days after beginning study drug or placebo||||units on a scale||Standard Deviation|Mean
1297178|NCT00053703|Secondary|Change From Baseline in Body Mass Index Change, kg/m2, at Week 8|Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||kg/m2||Standard Deviation|Mean
1297179|NCT00053703|Primary|Change From Baseline in PANSS Negative Symptom Subscale at Week 8|The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.|8 weeks||||units on a scale||Standard Deviation|Mean
1297180|NCT00053703|Primary|Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.|The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1297181|NCT00053703|Secondary|Change From Baseline in Barnes Akathisia Scale at Week 8|Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1297182|NCT00053703|Secondary|Change From Baseline in Weight at Week 8|change in weight from baseline to week 8 in kg|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||Kg||Standard Deviation|Mean
1297201|NCT00053417|Primary|Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test|The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).|Baseline (placebo run-in period); 12-week stable dose period||||percent change||Full Range|Median
1297183|NCT00053703|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks|Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores > that 60 are considered clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1297184|NCT00053677|Primary|Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)|A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value.|18 weeks||||units on a scale||Standard Deviation|Mean
1297185|NCT00053495|Other Pre-specified|Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 (baseline) and 15 post-vaccination|Hematology parameters were evaluated in the safety, intent-to-treat population.|||x10-6th/μL||Standard Deviation|Mean
1297186|NCT00053495|Other Pre-specified|Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 (baseline) and 15 post-vaccination|Hematology parameters were evaluated in the safety, intent-to-treat population.|||Percentage (%)||Standard Deviation|Mean
1297187|NCT00053495|Primary|Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|Plaque-reduction neutralization test (PRNT50) titers were determined in the antibody evaluable, per-protocol population|||Participants|||Number
1297188|NCT00053495|Other Pre-specified|Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in safety, intent-to-treat population|||mg/dL||Standard Deviation|Mean
1297189|NCT00053495|Other Pre-specified|Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in safety, intent-to-treat population|||IU/L||Standard Deviation|Mean
1297190|NCT00053495|Other Pre-specified|Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 to 30 post-vaccination|Treatment-emergent rash events were assessed in the safety, intent-to-treat population.|||Participants|||Number
1297191|NCT00053495|Primary|Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|Neutralizing antibody response titers were evaluated in the antibody evaluable, per-protocol population.|||PRNT50 Titers||Standard Deviation|Mean
1297192|NCT00053495|Primary|Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine|The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.|Days 0 to 30 post-vaccination|Adverse events were assessed in the safety, intent-to-treat population|||Participants|||Number
1297193|NCT00053482|Other Pre-specified|Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in the intent-to-treat safety population|||IU/L||Standard Deviation|Mean
1297194|NCT00053482|Other Pre-specified|Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in the intent-to-treat safety population|||mg/dL||Standard Deviation|Mean
1297195|NCT00053482|Other Pre-specified|Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|The hematology parameters were assessed in the intent-to-treat safety population.|||x10^6th/µL||Standard Deviation|Mean
1297196|NCT00053482|Other Pre-specified|Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|The hematology parameters were assessed in the intent-to-treat safety population.|||Percentage (%)||Standard Deviation|Mean
1297197|NCT00053482|Other Pre-specified|Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 to 30 post-vaccination|Treatment-emergent rash events were assessed in the safety intent-to-treat population.|||Participants|||Number
1297198|NCT00053482|Primary|Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 to 30 post-vaccination|Post-vaccination adverse events were assessed in the safety, intent-to-treat population.|||Participants|||Number
1297199|NCT00053482|Primary|Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination||||Participants|||Number
1297200|NCT00053482|Primary|The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine|The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)|Day 30 post-vaccination|The neutralizing antibody response titers were assessed in the antibody evaluable, per-protocol population.|||PRNT50 Titers||Standard Deviation|Mean
1297218|NCT00003830|Primary|Morbidity - Number of Participants With Residual Arm Numbness|Morbidity as measured by residual arm numbness|before and after surgery (within 30 days of randomization)|Data missing or unknown for some patients|||Participants|||Count of Participants
1297202|NCT00053365|Secondary|Progression-free Survival|Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria, progression is defined as at least a 20% increase in the sum of longest dimesions(LD) of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|From entry into study to death or date of last contact, assessed up to 5 years|Eligible and evaluable|||months||95% Confidence Interval|Median
1297203|NCT00053365|Primary|Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and evaluable patients|||participants|||Number
1297204|NCT00053365|Primary|Tumor Response|"Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria: Complete Response is disappearance of all target and non-target lesions; Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Response is to be evaluated every 42 days for the first 6 months and every 6 months thereafter while the patient is receiving study treatment, then every 3 months for 2 years and every 6 months for the next 3 years until documented progression or death."|From entry into study until documented progression or death, assessed up to 5 years.||||participants|||Number
1297205|NCT00053352|Secondary|Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0|The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy|Up to 126 days after the start of chemotherapy|182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint|||patients|||Number
1297206|NCT00053352|Secondary|Days Hospitalized for Patients Who Receive Chemotherapy|Calculated to quantify the treatment cost associated with this regimen.|Up to 126 days after the start of chemotherapy|182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint|||Days in the hospital||Standard Deviation|Mean
1297207|NCT00053352|Primary|Overall Survival (OS)|Percentage probability of being alive at 3 years following enrollment.|3 Years after enrollment||||Percent Probability||95% Confidence Interval|Number
1297208|NCT00053352|Primary|Event-Free Survival (EFS)|Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.|3 Years after enrollment|181 patients were evaluated for event free survival through 3 years for patients enrolled on Arm 1. Event-free survival is not a primary outcome measure for Arm 2 patients.|||Percent probability||95% Confidence Interval|Number
1297209|NCT00053014|Secondary|Serious Adverse Events|Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.|9 months|All patients|||participants|||Number
1297210|NCT00053014|Primary|Overall Survival|measured from date of registration to study until death from any cause with patients still alive censored at date of last contact|1 year||||participants|||Number
1297211|NCT00003830|Secondary|Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.|Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.|At time of surgery (within 30 days of randomization)|Data not collected for some patients. This analysis as pre-specified in the approved B-32 protocol required that both a SLN resection and an ALND be performed. The patients in Arm II were assigned to have no ALND so were excluded from the analysis.|||Participants|||Count of Participants
1297212|NCT00003830|Secondary|The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.|Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.|At time of surgery (within 30 days of randomization)|Data missing or unknown for some patients. In Arm I, 19 patients did not accept the protocol and another 42 patients did not have a SLN resection leaving 2746 with a SLN resection. In Arm II, 4 declined the protocol treatment and another 10 patients did not have a SLN resection leaving 2790 with a SLN resection.|||Participants|||Count of Participants
1297213|NCT00003830|Secondary|Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence|Measured at time from randomization to any distant cancer or death to determine percentage of patients distant disease free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.|From the time of randomization until 5 years|Data missing or unknown for some patients|||percentage distant disease free at 5 yrs|||Number
1297214|NCT00003830|Secondary|Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence|Percentage of patients distant disease-free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.|From the time of randomization until 5 years|Data missing or unknown for some patients.|||percentage of patients|||Number
1297215|NCT00003830|Primary|Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.|Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.|8 years||||percentage pts disease free at 8 years||95% Confidence Interval|Number
1297216|NCT00003830|Primary|Overall Survival|Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years|8 years|Data missing or unknown for some patients|||percentage of patients alive at 8 years||95% Confidence Interval|Number
1297217|NCT00003830|Primary|Morbidity - Number of Participants With Residual Arm Tingling|Morbidity as measured by residual arm tingling|before and after surgery (within 30 days of randomization)|Data missing or unknown for some patients|||Participants|||Count of Participants
1297219|NCT00003830|Primary|Morbidity - Number of Participants With Residual Arm Volume Difference|Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery|before and after surgery (within 30 days of randomization)|Data missing or unknown for some patients.|||Participants|||Count of Participants
1297220|NCT00003830|Primary|Morbidity - Number of Participants With Residual Shoulder Abduction Deficit|Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.|Before and after surgery (within 30 days of randomization)|Data missing or unknown for some patients|||Participants|||Count of Participants
1297221|NCT00052962|Secondary|Number of Participants With an Adverse Event|Here is the number of participants with an adverse event. For a detailed list of adverse events see the adverse event module.|2003-2008|Three participants were not included in the analysis because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.|||Participants|||Number
1297222|NCT00052962|Primary|Progression Free Survival|"CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter.~Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans."|2003-2008|Study was closed July 2008 because the PI left the institution, thus the objective was not met.||||||
1297223|NCT00052910|Secondary|Disease Free Survival|Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.|From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years||||years||95% Confidence Interval|Median
1297224|NCT00052910|Primary|Overall Survival|Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From study enrollment until death from any cause; up to 3 years||||years||95% Confidence Interval|Median
1297225|NCT00052715|Secondary|To Determine Tumor Response|Tumor response to treatment with Poly-ICLC|2 years|Data was not collected for this outcome measure due to reports of transient enlargement of contrast enhancing disease with subsequent shrinkage during Poly-ICLC treatment and the lack of central radiological review, the protocol defined criteria for radiological response could not be employed because of the risk of inconsistent results||||||
1297226|NCT00052715|Secondary|To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC|Descriptive measure per investigator to describe change in neurological status post-intervention.|1 year|Data was not collected for this outcome measure due to premature discontinuation of study agent in response to what turned out to be pseudo-progression.||||||
1297227|NCT00052715|Secondary|to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients|CTCAE 4|2 years||||participants|||Number
1297228|NCT00052715|Secondary|Determine the 12-month Survival Rate|12-month survival rate calculated from date of diagnosis|1 year||||percent of participants|||Number
1297229|NCT00052715|Secondary|To Determine 6 Months Progression Free Survival|Patients evaluated from date of diagnosis to the 6 month scan|6 months||||percentage of participants|||Number
1297230|NCT00052715|Primary|Overall Survival in Pts With Newly Diagnosed GBM|Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM|2 years|Four patents were censored for survival at 35, 114, 126, and 166 weeks|||weeks||95% Confidence Interval|Median
1297231|NCT00052429|Primary|Local Control of Participants|Patients will be classified as controlled as long as there is no clinical or radiographic evidence of disease progression. Physical exam with fiberoptic nasopharyngoscopy will be performed approximately every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.|every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.||||percentage of participants|||Number
1297232|NCT00052429|Primary|Survival Rate of Patients|Patients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.|up to 77 months||||months||Full Range|Median
1297233|NCT00049543|Secondary|Incidence of Toxicities Graded Using the NCI Common Terminology Criteria for Adverse Events Version 3.0|The incidence of toxicities will be summarized by type of adverse event and severity. A Fisher’s exact test will be used to compare toxicities between the two arms.|Up to 5 years|All patients who received at least 1 dose of the treatment|||participants|||Number
1297234|NCT00049543|Secondary|Disease Free Survival|The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the disease free survival between two arms adjusting for the stratification factors. Five years disease free survival rate will be reported.|From randomization to the time of documented recurrence of the primary cancer, assessed up to 5 years|ITT population|||percentage of 5-year disease free rate||95% Confidence Interval|Number
1297235|NCT00049543|Primary|Overall Survival|The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported.|From randomization to the time of death from any cause, assessed up to 5 years|ITT population|||percentage of 5 years survival rate||95% Confidence Interval|Number
1297236|NCT00049530|Secondary|Overall Survival|Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.|assessed every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated|||months||95% Confidence Interval|Median
1297526|NCT00026494|Primary|Radiographic Response Assessed by Macdonald Criteria Every 2 Months|All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.|2 years||||participants|||Number
1297237|NCT00049530|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.|assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated patients|||months||95% Confidence Interval|Median
1297238|NCT00049530|Secondary|Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)|"Objective tumor response was assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions. Stable disease (SD) = did not meet criteria for response or progression.~Non-progression rate = CR + PR + SD."|assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
1297239|NCT00049530|Primary|Plasma b-FGF Level Response|The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.|assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
1297240|NCT00049517|Secondary|Overall Survival (Consolidation Phase)|Overall survival is defined as the time from randomization in the consolidation phase to death.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.|Only 270 patients who were randomized in the consolidation phase are included in the analysis.|||Months||95% Confidence Interval|Median
1297241|NCT00049517|Primary|Disease-free Survival (Consolidation Phase)|Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.|Only 270 patients who were randomized in the consolidation phase are included in the analysis.|||Months||95% Confidence Interval|Median
1297242|NCT00049517|Primary|Overall Survival (Induction Phase)|Overall survival is defined as the time from randomization in the induction phase to death.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.|All randomized patients are included in the analysis (intention-to-treat).|||months||95% Confidence Interval|Median
1297243|NCT00049504|Primary|Non-relapse-related Mortality|Number of deaths without progression or recurrence of malignant disease|Up to 200 days after transplantation||||Participants|||Count of Participants
1297244|NCT00049504|Primary|Incidence of Grades III-IV Acute GVHD|Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity|At any time within 200 days after transplantation||||Participants|||Count of Participants
1297245|NCT00049504|Primary|Donor Engraftment (Chimerism)|Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population|At day +84 after transplantation|Patients receiving haploidentical transplant who had T cell chimerism tested at day +84|||Participants|||Count of Participants
1297246|NCT00049322|Secondary|Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab||21 days after TACE||||fold change|||Number
1297247|NCT00049322|Secondary|Assess Pharmakokinetics of Bevacizumab in Liver Disease|bevacizumab serum concentrations|day 85||||micrograms/mL||95% Confidence Interval|Mean
1297248|NCT00049322|Secondary|Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment||16 weeks|subjects that completed all 16 weeks.|||participants|||Number
1297249|NCT00049322|Secondary|Progression Free Survival|Progression free survival (PFS) at 16 weeks (end of the core phase).|16 weeks|Arm I: Patients receive bevacizumab Arm II. Patients do not receive bevacizumab.|||probablility of pfs at 16 weeks|||Number
1297250|NCT00049322|Primary|Neovessel Formation as Measured by Angiogram at 14 Weeks|Angiograms were assessed for changes in vascularity. The numbers indicate how many subjects in each group showed neovessel formation.|14 weeks||||participants|||Number
1297251|NCT00049257|Secondary|Overall Survival Rate|Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.|Assessed every two months after completion of study treatment for 4 years||||participants|||Number
1297252|NCT00049257|Secondary|Objective Response Rate|Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.|Evaluated every 12 weeks during Treatment Period||||participants|||Number
1297253|NCT00049257|Primary|Time to PSA Progression|In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by >=5ng/ml, confirmed by a second value at >=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is >=5ng/ml and is confirmed by a second value at >=4 week intervals.|Evaluated every 28 days during Treatment Period||||days||Full Range|Median
1297254|NCT00049257|Primary|Prostate-specific Antigen (PSA) Response Rate|PSA response is defined as a decline from the baseline value of >=50% confirmed by a second PSA value 4 or more weeks later.|Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.||||participants|||Number
1297255|NCT00049127|Secondary|Overall Time to Death|Kaplan-Meier survival curves and logrank tests will be used to estimate survival distributions.|Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years||||months||95% Confidence Interval|Median
1297256|NCT00049127|Secondary|Percentage of Patients Progression-free|"The percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions.~Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|Time from study registration to date of disease progression or last follow-up, assessed up to 5 years||||months||95% Confidence Interval|Mean
1297257|NCT00049127|Secondary|Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment).|"Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance.~Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), >=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Up to 5 years||||percentage of confirmed responses|||Number
1297258|NCT00049127|Primary|6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration.|"The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm.~Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|6 months||||percentage of patients|||Number
1297259|NCT00049036|Primary|Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment|Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma|60 days|ITT|||proportion|||Number
1297260|NCT00048997|Secondary|Number of Subjects With Central Nervous System (CNS) Metastases in the First Year|The presence of metastases were determined by computerized tomography (CT) of the brain with and without contrast or by magnetic resonance imaging (MRI) of the brain with and without gadolinium, using the same method that was done prior to study entry.|From randomization to one year (Scans given at 6 and 12 months and additionally at other times within the time frame if clinically indicated.)|Eligible patients|||Participants|||Count of Participants
1297261|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Communications Deficit From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain-20 (EORTC QLQ-B20) at One Year|The EORTC QLQ-B20 is a 20-item self-report that assesses 11 symptom scales/items such as future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = “not at all” to 4 = “very much.” It is meant for use among brain cancer patients varying in disease stage and treatment modality (i.e. surgery, chemotherapy, radiotherapy, etc.) and should always be complemented by the QLQ-C30. The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. An increase from baseline to one year by >= 10 points was considered deterioration.|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-B20 communications deficit score|||percentage of participants||95% Confidence Interval|Number
1297262|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Future Uncertainty From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain-20 (EORTC QLQ-B20) at One Year|The EORTC QLQ-B20 is a 20-item self-report that assesses 11 symptom scales/items such as future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = “not at all” to 4 = “very much.” It is meant for use among brain cancer patients varying in disease stage and treatment modality (i.e. surgery, chemotherapy, radiotherapy, etc.) and should always be complemented by the QLQ-C30. The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. An increase from baseline to one year by >= 10 points was considered deterioration.|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-B20 future uncertainty score|||percentage of participants||95% Confidence Interval|Number
1297272|NCT00047385|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test.|Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If participant received 3 positive screens with documented follow-up after each one, he/she would be counted 3 times in the number of units analyzed.|||Pos. screens w/ complications|Participants||Number
1297263|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Fatigue From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year|The EORTC QLQ is an integrated system for assessing the health-related quality of life (QOL) of cancer patients participating in international clinical trials. The QLQ Core-30 (QLQ-C30 ) is a 30-item self-report questionnaire that has patients rate the items on a 4-point scale, with 1 “not at all” to 4 “very much” and is composed of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0-100. A high score for a symptom scale/item represents a high level of symptomatology/problems. An increase from baseline to one year by >= 10 points was considered deterioration.|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-C30 cognitive fatigue score|||percentage of participants||95% Confidence Interval|Number
1297264|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Cognitive Functioning From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year|The EORTC QLQ is an integrated system for assessing the health-related quality of life (QOL) of cancer patients participating in international clinical trials. The QLQ Core-30 (QLQ-C30 ) is a 30-item self-report questionnaire that has patients rate the items on a 4-point scale, with 1 “not at all” to 4 “very much” and is composed of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0-100. A high score for a functional status represents a high QOL. An increase from baseline to one year by >= 10 points was considered deterioration.|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-C30 cognitive functioning score|||percentage of participants||95% Confidence Interval|Number
1297265|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Global Health Status From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year|"The EORTC QLQ is an integrated system for assessing the health-related quality of life (QOL) of cancer patients participating in international clinical trials. The QLQ Core-30 (QLQ-C30 ) is a 30-item self-report questionnaire that has patients rate the items on a 4-point scale, with 1 not at all to 4 very much and is composed of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0-100. A high score for the global health status represents a high QOL. An increase from baseline to one year by >= 10 points was considered deterioration."|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-C30 global health status score|||percentage of participants||95% Confidence Interval|Number
1297266|NCT00048997|Secondary|Percentage of Subjects With Deterioration in the Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recall Score at One Year|The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. The delayed recall part of the test involves memorizing a list of 12 targets and recalling them after a 20-minute delay. The raw score is derived by summing the number of targets correctly recalled and ranges from 0 to 12 with a higher score indicating better functioning. A patient was classified with deterioration if there was a statistically significant decrease in score from baseline to one year as determined by the method of reliable change index.|Baseline and one year post study entry|All eligible patients with a baseline and 12 month HVLT-R assessment.|||percentage of participants||95% Confidence Interval|Number
1297267|NCT00048997|Secondary|Percentage of Subjects With Deterioration in the Hopkins Verbal Learning Test - Revised (HVLT-R) Recall Score at One Year|The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. The recall part of the test involves memorizing a list of 12 targets for 3 consecutive trials for immediate recall. The raw score is derived by summing the number of targets correctly recalled and ranges from 0 to 36 with a higher score indicating better functioning. A patient was classified with deterioration if there was a statistically significant decrease in score from baseline to one year as determined by the method of reliable change index.|Baseline and one year post study entry|All eligible patients with a baseline and 12 month HVLT-R assessment.|||percentage of participants||95% Confidence Interval|Number
1297268|NCT00048997|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.|From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 12 months. Maximum follow-up at time of analysis was 96 months.|All eligible patients|||months||95% Confidence Interval|Median
1297269|NCT00047385|Secondary|T2 Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T2. Includes a comparison with images from T0 and T1 screens.|T2 (two years after entry)|All participants randomized were analyzed|||Participants|||Number
1297270|NCT00047385|Secondary|T1 Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.|T1 (one year after entry)|All participants randomized were analyzed|||Participants|||Number
1297271|NCT00047385|Secondary|T0 (Baseline) Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.|T0 (at study entry)|All participants randomized were analyzed.|||Participants|||Number
1297274|NCT00047385|Secondary|Deaths From All Causes in All Randomized Participants.|Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.|All events through December 31, 2009; median follow-up 6.5 years.|All participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1297275|NCT00047385|Primary|Lung Cancer Deaths|Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.|All events through December 31, 2009; median follow-up 6.5 years.|All participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1297276|NCT00047320|Secondary|Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity|The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.|During chemotherapy(up to 18 weeks)|A total of 102 eligible patients treated with induction chemotherapy were included.|||participants||95% Confidence Interval|Number
1297277|NCT00047320|Secondary|Number of Patients Experiencing Toxic Death|Toxic death, defined as death predominantly attributable to treatment-related causes.|During chemotherapy (up to 18 weeks)|A total of 102 eligible patients treated with induction chemotherapy were included.|||Participants|||Count of Participants
1297278|NCT00047320|Secondary|Overall Survival (OS)|Overall Survival was defined as time from study entry to death from any cause. Overall survival was estimated by KM estimate.|At 3 years from study entry|Two ineligible patients were excluded. A total of 102 eligible patients were analyzed.|||Probability||95% Confidence Interval|Number
1297279|NCT00047320|Secondary|Progression-free Survival (PFS)|Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate.|At 3 years from study entry|Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. one patient died without the disease progression reported. But the death was due to the disease. The death was counted as “event” when progression-free survival (PFS) was calculated. So EFS and PFS at 3 years were same.|||Probability||95% Confidence Interval|Number
1297280|NCT00047320|Secondary|The Probability of Event-free Survival (EFS)|Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm. Event-free survival was estimated by KM estimate.|At 3 years from study entry|Two ineligible patients were excluded. A total of 102 eligible patients were analyzed.|||Probability||95% Confidence Interval|Number
1297281|NCT00047320|Primary|Response to Induction Chemotherapy|A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response.|18 weeks|Of the 102 eligible patients, 85 completed induction chemotherapy with sufficient data to assess response. Central review response assessment is used.|||Participants|||Count of Participants
1297282|NCT00047008|Secondary|Correlation of COX-2 With Outcomes||From randomization to date of death or last follow-up|||||||
1297283|NCT00047008|Secondary|Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes||From randomization to date of death or last follow-up|||||||
1297284|NCT00047008|Secondary|Quality of Life||From randomization to 5 years|||||||
1297285|NCT00047008|Secondary|Rate of Grade 3-5 Toxicity||From start of treatment to last follow-up|||||||
1297286|NCT00047008|Secondary|Disease-free Survival|From randomization to date of failure (local or regional persistence/relapse, distant metastasis, secondary primary tumor or death) or last follow-up. Analysis occurs after 309 deaths have been reported.|From randomization to date of failure|||||||
1297287|NCT00047008|Secondary|Local-regional Control|From randomization to date of failure (local or regional persistence/relapse) or death or last follow-up. Analysis occurs after 309 deaths have been reported.|From randomization to date of failure|||||||
1297288|NCT00047008|Primary|Overall Survival (3-year Rate)|Time from randomization to death due to any cause or last known date alive. Median survival was not reached, therefore 3-year survival rates are reported.|From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported.|Eligible patients who did not withdraw consent.|||percentage of patients||95% Confidence Interval|Number
1297289|NCT00046930|Secondary|Response|Number of eligible participants in each response category. Categories, based on peripheral blood counts and bone marrow aspirate and biopsy, include complete remission (CR), partial remission (PR), morphologic complete remission (MCR), and relapse.|Assessed at the end of induction||||Participants|||Number
1297290|NCT00046930|Secondary|Progression-free Survival (PFS)|Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Eligible participants, as randomized. Patients who had neither documented progression nor death within 3 months of registration without disease evaluation were excluded.|||Months||95% Confidence Interval|Median
1297291|NCT00046930|Primary|Overall Survival (OS)|Time from randomization to death. Patients alive at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Eligible participants, as randomized|||Months||95% Confidence Interval|Median
1297292|NCT00046891|Secondary|Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.|Pearson correlation coefficients conceptually related objective TMT A and B and subjective self-report measures of cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.|||Pearson correlation coefficient|||Number
1297293|NCT00046891|Secondary|Associations Between Self-reported Cognition and the HSCS.|Pearson correlation coefficients conceptually related objective HSCS and subjective self-reported cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.|||Pearson correlation coefficient|||Number
1297294|NCT00046891|Secondary|Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)|Self-reported symptoms or side effects mean change from baseline to 1st post chemo visit (negative numbers indicate worsening symptoms). A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire. This patient diary contains several questions related to potential side effects and side benefits of Ginko Biloba measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity).|Baseline, 1st evaluation of post chemotherapy.|Secondary analyses uses all patients that reported data for baseline and post chemo visit.|||units on a scale||Standard Deviation|Mean
1297295|NCT00046891|Secondary|Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.|TMT A and B were analyzed by evaluating median changes from baseline to different time points. Lower scores are better. The Trail Making Test will provide additional validity and verification for the assessment of overall cognitive dysfunction. Abbreviations used for category titles in the table below: Baseline (BL), change (chg), month (mth).|Baseline, 1, 6, 12, 18 and 24 months post chemotherapy.|Secondary analysis uses all patients that reported baseline and at least one post baseline time point data.|||seconds||Full Range|Median
1297296|NCT00046891|Secondary|Median Scores for Trail Making Tests A and B (Lower Scores Are Better).|The Trail Making Test is a measure of overall brain dysfunction. Time taken to complete TMT tests was recorded. For this analysis median values of the Trail Making tests are calculated at different time points.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for all the time points.|||seconds||Full Range|Median
1297297|NCT00046891|Primary|The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.|The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.|Baseline, 12 months after starting Chemotherapy.|Efficacy analyses uses all patients that reported baseline and one value after baseline.|||units on a scale*months||Standard Deviation|Mean
1297298|NCT00046839|Primary|Overall Survival|Because only 21 patients (18 analyzable) out of 128 planned were accrued on this study, all analyzable patients were combined to report overall survival. The original study design planned for a comparison to a historical control, but due to the small number of patients, survival time is only reported, not tested.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|Eligible patients who started protocol treatment.|||years||95% Confidence Interval|Median
1297299|NCT00046839|Primary|Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT)|"Patients were followed for at least 90 days from start of RT and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as grade 3 or 4 nonhematologic (excluding nausea, vomiting, and alopecia) and grade 4 hematologic toxicities. Six patients were to be accrued at each dose level. If no more than three of the six patients experienced a DLT then that dose level was considered acceptable and dose escalation occurred by accruing six more patients at the next dose level. Otherwise, the preceding dose level, if any, would be declared the MTD. The MTD would be used for the Phase II arm. At a given dose, the probability of halting dose escalation when the true toxicity is 50% or higher is at least 66% (power). In addition, if the true DLT rate is instead 20%, there will still be a 10% probability of halting dose escalation at a given dose level (type I error).~Rating scale: 0 = not the MTD, 1 = MTD"|Start of treatment to 90 days|The first six eligible patients who started protocol treatment at each dose level.|||units on a scale|||Number
1297300|NCT00045734|Other Pre-specified|Determine Correlating Molecular Abnormalities in the Tumor With Response to Treatment|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over Baseline (BL) if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|3 years|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.||||||
1297301|NCT00045734|Other Pre-specified|Evidence of Platelet-derived Growth Factor (PDGF) Inhibition in Tumor Specimens|insufficient samples to allow Platelet-derived growth factor receptor (PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue|- 3 years|insufficient samples to allow PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue||||||
1297302|NCT00045734|Other Pre-specified|Determine Surrogate Markers of Angiogenic Peptides Using Functional Neuro-imaging and in Vitro Bioassays|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due number of patients.|5 years|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.||||||
1297303|NCT00045734|Secondary|Determine Survival for Patients Treated With Imatinib Mesylate|survival determined from start of treatment to date of death|3 years|death date of 7 patients were unknown at time of analysis|||months||Full Range|Median
1297304|NCT00045734|Secondary|Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)|"Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1~result is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8"|pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9|Only 14 samples available / evaluable for analysis|||ng/ml||Standard Deviation|Mean
1297546|NCT00026221|Secondary|Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa|Analyzed by Enzyme-Linked Immunosorbent Assay (ELISA).VEGF only analyzed at baseline.|At baseline||||pg/mL||Full Range|Median
1297305|NCT00045734|Secondary|Tumor Response as Assessed by MRI Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|Up to 5 years|response at first scan|||participants|||Number
1297306|NCT00045734|Secondary|Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0|percentage of patients who had grade 3 or grade 4 adverse events|Up to 5 years after completion of study treatment||||percentage of patients|||Number
1297307|NCT00045734|Secondary|Progression-free Survival According to Response Evaluation Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|3 years|Of the 22 eligible patients only 19 were evaluable for response|||months||Full Range|Median
1297308|NCT00045734|Primary|6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging [MRI]) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|At 6 months|Only 19 of the 23 patients were evaluable for response|||percentage of participants|||Number
1297309|NCT00045708|Secondary|Percent of Subjects With 6M Progression Free Survival at the Phase 2 Arm of Study|subjects who are progression free at 6 month scan|6 months|19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.|||percent of patients||95% Confidence Interval|Number
1297310|NCT00045708|Secondary|The Duration of Progression Free Survival (Phase 2)|only patients treated on the nonP450 MTD|1.5 years|19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.|||months||95% Confidence Interval|Median
1297311|NCT00045708|Secondary|Duration of Overall Survival||1.5 years||||months||95% Confidence Interval|Median
1297312|NCT00045708|Primary|Grade 3 and 4 Toxicity (NCI Common Terminology Criteria for Adverse Events Associated With BMS-247550 Treatment in at Least 5% of Patients|Proportion of patients with serious or life threatening toxicities in at least 5% of patients|Up to 30 days post treatment||||Participants|||Count of Participants
1297313|NCT00045708|Primary|Response Rate of Patients at the MTD|"Complete Response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable/improving neurologic exam for min4 wks.~Partial Response: Greater than or equal to 50% reduction in tumor size on volumetric MRI scan, on a stable/decreasing dose of glucocorticoids, with stable/improving neurologic examination for min 4 wks.~Progressive Disease: Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the volume of the tumor by MRI scan. If neurologic status deteriorates, on stable/increasing dose of steroids, or if new lesions appear on serial MRI, further study treatment will be discontinued.~Stable Disease: A patient whose clinical status and MRI volumetrics do not meet the criteria for Complete Response, Partial Response or Progressive Disease."|3 years|no objective responses observed. 19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.|||participants|||Number
1297314|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Volume of Distribution at Steady State as Related to BMS-247550 and Anticonvulsants|Vss = volume of distribution at steady-state (how widely distributed in the body the drug gets)|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set|||l/m2||Standard Deviation|Mean
1297315|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Clearance as Related to BMS-247550 and Anticonvulsant Measurements|CL = clearance (how much volume of blood is cleared of the drug per unIT of time|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set|||l/h/m2||Standard Deviation|Mean
1297331|NCT00045305|Secondary|Proportion of Graft Versus Host Disease|Proportion of Graft versus Host Disease is calculated as number of patients with Graft versus Host Disease divided by all eligible and treated patients|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
1297316|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Estimation of Half-lives Related to BMS-247550 and Anticonvulsants|T1/2,z = terminal half-life (T1/2) --- for a 2 or 3 compartment drug, idea of how long drugs stick around|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set|||h||Standard Deviation|Mean
1297317|NCT00045708|Primary|Group A (P450) Estimated MTD and Group B (nonP450) Estimated MTD of BMS-247550 in Patients With Recurrent or Progressive Malignant Glioma|Starting dose for both Group A and Group B was 5mg/m2/day. A continuing reassessment method (CRM) was employed independently for each group to estimate the maximum tolerated dose. Only toxicity observed during 1st cycle of treatment (21 days) was used for dose finding. Dose limiting toxicity (DLT) defined as: ANC<500/ul, platelets<25,000, febrile neutropenia or treatment-related grade 3 or 4 non-hematologic toxicity with the exception of nausea and vomiting.|21 days (1 cycle)||||mg/m2/day|||Number
1297318|NCT00045708|Primary|Number of Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) of BMS-247550 in Patients With Recurrent or Progressive Malignant Glioma|Starting dose for both Group A and Group B was 5mg/m2/day. A continuing reassessment method (CRM) was employed independently for each group to estimate the maximum tolerated dose. Only toxicity observed during 1st cycle of treatment (21 days) was used for dose finding. Dose limiting toxicity (DLT) defined as: ANC<500/ul, platelets<25,000, febrile neutropenia or treatment-related grade 3 or 4 non-hematologic toxicity with the exception of nausea and vomiting.|21 days (1 cycle)|4 subjects from Group B (Phase 1) were included in Group 3 (Phase 2). Only those on non-anticonvulsants at the dose of 6.8mg/m2/day were treated in Phase 2. No subjects treated at the MTD for P450, as the accrual goal for phase 2 reached before MTD for p450 was determined. P450 MTD determined as 9.6mg/m2 per CRM after all enrollment of phase 2|||DLTs|||Number
1297319|NCT00045630|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1297320|NCT00045630|Secondary|Overall Survival (OS)|Overall survival is defined from the date of registration to date of death from any cause|0-2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1297321|NCT00045630|Primary|Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy|Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.|up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1297322|NCT00045487|Primary|Number of Patients With Ani-tumor Activity After Taking OSI-774.|Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).|Disease progression or 52 weeks duration|Intent to treat analysis.|||participants|||Number
1297323|NCT00045435|Secondary|Incidence of Acute and Chronic GVHD|Percent patients with acute/chronic GVHD|aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.||||percentage of participants|||Number
1297324|NCT00045435|Secondary|Incidence of Rejection|Percent patients who developed infections post-transplant.|By 1 year after transplant||||percentage of participants|||Number
1297325|NCT00045435|Secondary|Incidence of Relapse|Percent patients with relapsed disease post-transplant.|By 1 year after transplant||||percentage of participants|||Number
1297326|NCT00045435|Secondary|Overall Survival|Percent patients surviving.|By 1 year after transplant||||percentage of participants|||Number
1297327|NCT00045435|Primary|Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death|Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%.|200 days after transplant||||percentage of participants|||Number
1297328|NCT00045435|Primary|Disease-free Survival-incidence of Survival Without Relapse|Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%.|By 1 year after transplant||||percentage of participants|||Number
1297329|NCT00045305|Secondary|Time to Engraftment for Platelet|Time to platelet engraftment is defined from date of infusion to date of platelet engraftment. The platelet engraftment is defined as platelets > 20,000 on two consecutive measurements, at least seven days apart, without platelet transfusions in between and for at least three days before the first measurement that is over 20,000. The date of engraftment is the date of the first measurement that is over 20,000.|Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.|eligible and treated patients|||days||95% Confidence Interval|Median
1297330|NCT00045305|Secondary|Time to Engraftment for Neutrophil|Time to neutrophil engraftment is defined from date of infusion to date of neutrophil engraftment. Neutrophil engraftment is defined as ANC > 500/mm3 on two consecutive measurements. The date of engraftment is the date of the first ANC > 500/mm3.|Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.|eligible and treated patients|||days||95% Confidence Interval|Median
1297566|NCT00025506|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
1297332|NCT00045305|Secondary|Overall Survival|Overall survival (OS) is defined to be the time from registration to death from any cause, with follow-up censored at the date of last contact. Kaplan-Meier method was used to estimate the distribution of OS.|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients|||years||95% Confidence Interval|Median
1297333|NCT00045305|Secondary|Number of Patients Who Developed Disease Progression After Achieving Complete Response|Disease free survival (DFS) was listed as a secondary endpoint in the study protocol, which would be assessed in patients who achieved complete response (CR). It was defined to be time from CR to documented progression or to death without progression. Patients without documented progression or death reported were censored at the time of last disease evaluation. However, due to the small number of patients with CR, the number of patients who developed disease progression was reported here.|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients who achieved complete response|||participants|||Number
1297334|NCT00045305|Primary|Complete Response Rate|"Completed response is defined as:~Bone marrow evaluation: Repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation).~Peripheral blood evaluation [absolute values must last at least 2 months] Hemoglobin >11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present"|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1297335|NCT00045162|Secondary|Number of Patients With a Given Type and Grade of Adverse Event.|Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.|Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.|Eligible patients who received protocol treatment.|||Participants|||Number
1297336|NCT00045162|Secondary|Confirmed and Unconfirmed Complete and Partial Responses.|Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline. A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT). A complete response (CR) was defined as the disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters. Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.|Every 6 weeks while on protocol treatment for a maximum of 12 weeks||||participants|||Number
1297337|NCT00045162|Secondary|Progression-free Survival|Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and without evidence of progression were censored at the date of last contact.|Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.||||months||95% Confidence Interval|Median
1297338|NCT00045162|Primary|Overall Survival|Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.||||Months||95% Confidence Interval|Median
1297339|NCT00045110|Secondary|Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs|Drug administered 6 days prior to surgery|Pre-surgery and time of resection|sample 5 and 6 suspected of contamination with blood clot tumor/tissue concentration|||tumor/tissue concentration ng/g dry weig||Standard Deviation|Mean
1297340|NCT00045110|Secondary|Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs|Drug administered 6 days prior to surgery|Pre-surgery and time of resection|sample 5 and 6 suspected of contamination with blood clot|||plasma concentration ng/mL||Standard Deviation|Mean
1297341|NCT00045110|Secondary|Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|One sample on day 8 cycle 1|Cp=peak plasma concentration; tmax=time to Cp; AUC=area under the curve;|||ng/mL||Standard Deviation|Mean
1297342|NCT00045110|Secondary|Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg-|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|AUC=area under the curve;|||ug * h/mL||Standard Deviation|Mean
1297343|NCT00045110|Secondary|Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|tmax=time to peak plasma concentration;|||h||Standard Deviation|Mean
1297344|NCT00045110|Secondary|Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|Cpmax =peak plasma concentration;|||ng/mL||Standard Deviation|Mean
1297345|NCT00045110|Secondary|Trough Level Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|cycle 1 day eight|trough level|||ng/mL||Standard Deviation|Mean
1297346|NCT00045110|Secondary|Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|AUC=area under the curve|||ug* h/mL||Standard Deviation|Mean
1297347|NCT00045110|Secondary|Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|Cp=peak plasma concentration;|||ng/mL||Standard Deviation|Mean
1297348|NCT00045110|Secondary|Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1.|tmax=time of peak plasma concentration|||h||Standard Deviation|Mean
1297349|NCT00045110|Secondary|Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II|Summarized by descriptive statistics.|Up to 1 year|drug related events grade 3-5 CTCAE. 5 patients were not evaluable for response/toxicity.|||percent of participants|||Number
1297350|NCT00045110|Secondary|Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI~Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|At 1 year|recurrent malignant gliomas - anaplastic and glioblastoma|||participants|||Number
1297351|NCT00045110|Secondary|Overall Survival Newly Diagnosed GBM Post RT|Overall Survival defined as Time from Start of treatment to time of death due to any cause|2 years|not receiving Enzyme-inducing Antiepileptic Drugs, glioblastoma stable after RT|||months||95% Confidence Interval|Median
1297352|NCT00045110|Secondary|1 Year Survival - Phase II Newly Diagnosed GBM Post RT|12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT|At 1 year|not receiving Enzyme-inducing Antiepileptic Drugs; stable glioblastoma after RT|||% of participants|||Number
1297353|NCT00045110|Secondary|Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1|CTCAE|1 year|During Cycle 1 only grade 3 severity; patients on Enzyme-inducing Antiepileptic Drugs|||Participants|||Count of Participants
1297354|NCT00045110|Primary|6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)|Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|38 Glioblastoma, 15 anaplastic gliomas not receiving Enzyme-inducing Antiepileptic Drugs|||Participants|||Count of Participants
1297355|NCT00045110|Primary|Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts|standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.|cycle 1 - 28 days|Cohorts/dose levels: 150mg; 200mg; 275mg; 400mg; 525mg; 650mg; 775mg patients on Enzyme-inducing Antiepileptic Drugs|||mg|||Number
1297356|NCT00045110|Primary|Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I|DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib.|28 days|Patients were eligible if they had recurrent disease or if they were newly diagnosed post RT and did NOT have tumor progression (nonprogression glioblastoma) on Enzyme-inducing Antiepileptic Drugs|||dose limiting toxicities|||Number
1297357|NCT00045032|Secondary|Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up|Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value <50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.|From Baseline until time of event (maximum up to 10 years)|Safety Population|||percentage of participants||95% Confidence Interval|Number
1297358|NCT00045032|Secondary|Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up|Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.|From Baseline until time of event (maximum up to 10 years)|Safety Population: All participants randomized/enrolled in the study according to actual treatment received. Hence, participants assigned to Herceptin who received no study treatment were analyzed in the Observation Arm.|||percentage of participants||95% Confidence Interval|Number
1297642|NCT00022490|Primary|The Rate of Major Cytogenetic Response at 6 Months|Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.|6 months||||Participants|||Number
1297359|NCT00045032|Secondary|RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.|||percentage of participants||95% Confidence Interval|Number
1297360|NCT00045032|Secondary|Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.|||percentage of participants|||Number
1297361|NCT00045032|Secondary|DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
1297362|NCT00045032|Secondary|Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y|||percentage of participants|||Number
1297363|NCT00045032|Secondary|DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297364|NCT00045032|Secondary|Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up|The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
1297365|NCT00045032|Secondary|TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
1297366|NCT00045032|Secondary|Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y|||percentage of participants|||Number
1297367|NCT00045032|Secondary|TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297368|NCT00045032|Secondary|Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up|The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
1297369|NCT00045032|Secondary|DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
1297370|NCT00045032|Secondary|Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y|||percentage of participants|||Number
1297371|NCT00045032|Secondary|DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297372|NCT00045032|Secondary|Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
1297373|NCT00045032|Secondary|RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
1297374|NCT00045032|Secondary|Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y|||percentage of participants|||Number
1297375|NCT00045032|Secondary|RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297376|NCT00045032|Secondary|Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
1297377|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.|Years 3, 5, 7, 9, 10, 11, 12|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
1297378|NCT00045032|Secondary|Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 11 years)|FAS Population 1Y2Y|||percentage of participants|||Number
1297379|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.|Years 3, 5, 7, 9, 10, 11, 12|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297380|NCT00045032|Secondary|Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 11 years)|FAS Population|||percentage of participants|||Number
1297381|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297382|NCT00045032|Secondary|Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
1297383|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants||95% Confidence Interval|Number
1297384|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants||95% Confidence Interval|Number
1297385|NCT00045032|Secondary|Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants|||Number
1297463|NCT00033657|Secondary|Recurrence-free Survival Time|Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients.|Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry||||Months||95% Confidence Interval|Median
1297386|NCT00045032|Secondary|Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants|||Number
1297387|NCT00045032|Secondary|DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Years 3, 5, 7, 8, 9, 10|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
1297388|NCT00045032|Secondary|Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (maximum of 10 years)|FAS Population 1-Year Herceptin Versus 2-Year Herceptin (1Y2Y): Participants without a DFS event and still under follow-up at the pre-defined landmark of 366 days after randomization, analyzed when intent-to-treat principle was applied for comparison of 1 year versus 2 years of Herceptin.|||percentage of participants|||Number
1297389|NCT00045032|Primary|DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 10|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297390|NCT00045032|Primary|DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 9|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297391|NCT00045032|Primary|DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297392|NCT00045032|Primary|DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 7|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297393|NCT00045032|Primary|DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 5|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297394|NCT00045032|Primary|DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 3|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297395|NCT00045032|Primary|Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (maximum of 10 years)|FAS Population|||percentage of participants|||Number
1298349|NCT00047463|Secondary|Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP|Patients all received a CPAP machine which either delivered CPAP or provided the patient with placebo CPAP, which had the same sensation as receiving CPAP|10 weeks||||participants|||Number
1297396|NCT00045032|Primary|DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297397|NCT00045032|Primary|DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 7|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297398|NCT00045032|Primary|DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 5|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297399|NCT00045032|Primary|DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 3|FAS Population|||percentage of participants||95% Confidence Interval|Number
1297400|NCT00045032|Primary|Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
1297401|NCT00045032|Primary|DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants||95% Confidence Interval|Number
1297402|NCT00045032|Primary|DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants||95% Confidence Interval|Number
1297403|NCT00045032|Primary|Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants|||Number
1297415|NCT00042991|Secondary|Change From Baseline in Volume Enhancing at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Volume enhancing is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, for only 19 patients, enhacing tumor was greater than zero based on brain MRI scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the enhancing volumetric data from these 19 patients.|||cc||Full Range|Median
1297404|NCT00045032|Primary|Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants|||Number
1297405|NCT00042991|Secondary|Number of Patients With Epidermal Growth Factor Receptor (EGFR) Amplification|Epidermal growth factor receptor (EFGR) is a protein found on the surface of cells to which epidermal growth factor (EGF) binds. When EGF attaches to EGFR, it activates the enzyme tyrosine kinase, triggering reactions that cause the cells to grow and multiply.|Pre-treatment|Epidermal growth factor receptor is only possible with tumor sample, which is only potentially available from supratentorial malignant glioma patients treated on Stratum-1B and Stratum-2. Of 10 Stratum-1B and 3 Stratum-2 patients (n=13), tumor material was available from 11 patients (8 in Stratum-1A and 3 in Stratum-2).|||Participants|||Number
1297406|NCT00042991|Secondary|Gefitinib Area Under the Concentration Curve From 0-24 Hours (AUC)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||mcg/L*hr||Full Range|Median
1297407|NCT00042991|Secondary|Time of Maximum Clearance of Gefitinib (Tmax)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||Hour||Full Range|Median
1297408|NCT00042991|Secondary|Clearance of Gefitinib (Cl)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||L/hr/m2||Full Range|Median
1297409|NCT00042991|Secondary|Elimination Half Life of Gefitinib (t1/2)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||hour||Full Range|Median
1297410|NCT00042991|Secondary|Peak Serum Concentration of Gefitinib (Cmax)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||mcg/ml||Full Range|Median
1297411|NCT00042991|Secondary|Mean Tumor to White Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.|Baseline|Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.|||Ratio||Full Range|Median
1297412|NCT00042991|Secondary|Mean Tumor to Gray Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.|Baseline|Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.|||Ratio||Full Range|Median
1297413|NCT00042991|Secondary|Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Perfusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, 20 patients had perfusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 20 patients.|||Ratio||Full Range|Median
1297414|NCT00042991|Secondary|Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Diffusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, 29 patients had diffusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 29 patients.|||Ratio||Full Range|Median
1297461|NCT00036738|Secondary|Leukemia-free Survival|Number of patients surviving in CR up to five years post-transplant.|Assessed up to 5 years||||Participants|||Count of Participants
1297416|NCT00042991|Secondary|Change in Tumor Volume Measured on Fluid Attenuated Inversion Recovery (FLAIR) Imaging at Before the Protocol Therapy Started and at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. In this particular objective, the study aimed to investigate how radiation+gefitinib affect the tumor volume. Tumor volume is measured using Fluid Attenuated Inversion Recovery (FLAIR) before and after the radiation therapy.|Baseline and two weeks post completion of radiation|Out of 43 patients, 35 patients had brain MRI before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 35 patients.|||cc||Full Range|Median
1297417|NCT00042991|Primary|Median Survival in Newly Diagnosed Brain Stem Gliomas|Overall survival is defined as the interval from initiation of treatment to death or date of last contact for surviving patients|Assessed from the start of therapy until three years after initiation of gefitinib therapy||||Months||Full Range|Median
1297418|NCT00042991|Primary|Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas|Progression-free survival is defined as the interval from intiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurlogical status) or death for patients who failed or to the last date of follow-up for patients without failure|Assessed pre-radiation, every 8 weeks for 13 courses of therapy, and then every 12 weeks|Here, we only report the results for Phase-II trial as this objective was specifically for the Phase-II trial. This cohort includes seven patients who were treated during Phase-I at Dose 250 mg/m^2 of Gefitinib.|||Months||Full Range|Median
1297419|NCT00042991|Primary|Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy|The dose limiting toxicity (DLT) analysis population consists of stratum 1A phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD based on the tradional 3+3 design, where a dose is considered a safe dose only when 0 out of 3, or at most 1 out of 6 patients has DLTs. When two or more patients in a group of 2 to 6 patients had DLTs, then that dose level was considered to be too toxic.|Day 1 of gefitinib therapy to end of week 8|This cohort includes only the patients who were enrolled and treated on Gefitinib+Radiation during the Phase I component of the trial, where the safety of Gefitinib was assedded at Dose Levels 100 mg/m^2, 250 mg/m^2, and 375 mg/m^2.|||Participants|||Number
1297420|NCT00042939|Secondary|Proportion of Patients With Thromboembolic Events|To determine the rate of thromboembolic events in this population when prophylactic enoxaparin sodium is administered.|Assessed every 6 weeks while on treatment and for 30 days after the end of treatment|Eligible and treated patients|||Proportion of participants||90% Confidence Interval|Number
1297421|NCT00042939|Secondary|Epidermal Growth Factor Receptor (EGFR) Status|EGFR expression was be evaluated by staining 5-micron paraffin sections of tumor biopsies with anti-EGFR clone 2-18C9 (DAKO Corporation, Carpinteria, CA) using an indirect immunoperoxidase technique according to the instructions provided by DAKO. In brief, this includes an antigen retrieval pretreatment, the blocking of endogenous peroxidase activity, incubation with anti-EGFR antibody or a negative reagent control, staining with a detection system, visualization, and coverslipping.|Original tumor tissue samples submitted within one month of patient randomization|Eligible and treated patients with EGFR stain results available.|||participants|||Number
1297422|NCT00042939|Secondary|Overall Survival|Overall survival was defined as time from registration to death from any cause.|Assessed every 3 months for 2 years and then every 6 months for 1 year|Eligible patients who began treatment.|||months||90% Confidence Interval|Median
1297423|NCT00042939|Secondary|Progression-free Survival|"Progression-free survival was defined as the shorter of:~The time from registration to progression. or~The time from registration to death without documentation of progression given that the death occured within 4 months of the last disease assessment without progression (or registration, whichever is more recent).~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every 3 months for 2 years and then every 6 months for 1 year|Eligible patients who began treatment.|||months||90% Confidence Interval|Median
1297424|NCT00042939|Primary|Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)|"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Assessed every 12 weeks until progression|Eligible patients who began treatment were included in the analysis.|||Proportion of participants||90% Confidence Interval|Number
1297425|NCT00041132|Secondary|Overall Survival|Overall Survival rate at 1 year. Time to death is from date of registration to date of death due to any cause.|assessed after cycle 4, after completion of treatment, then every 3 months for 2 years, then every 6 months thereafter until 5 years||||percentage of participants||95% Confidence Interval|Number
1297426|NCT00041132|Secondary|Response|Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of nodes; no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. CRU is complete disappearance of all measurable and non-measurable disease; regressed, non-palpable organs; and one or more exceptions not qualifying for CR (see protocol section 10). PR applies to patients with at least one measurable lesion who do not qualify for CR or CRU. PR is a 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD.|assessed after cycle 4 and after completion of treatment (168 days)||||participants|||Number
1297462|NCT00036738|Primary|Relapse Free Survival|Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of > 5% blasts after a documented complete remission.|Assessed up to 1 year||||Participants|||Count of Participants
1297427|NCT00041132|Primary|Progression-free Survival|Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression.|assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration||||percentage of participants||95% Confidence Interval|Number
1297428|NCT00041119|Secondary|Overall Survival (OS) for 4 vs. 6 Cycles|To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for overall survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.|from baseline up to 4 years|All patients that were eligible and received treatment were analyzed.|||percentage of patients at 4 years|||Number
1297429|NCT00041119|Secondary|Local Control|Local control will be calculated as the cumulative incidence of first local relapse.|from baseline up to 15 years|All patients that were eligible and received treatment were analyzed.|||years||Full Range|Median
1297430|NCT00041119|Secondary|Time to Distant Metastases|Local control and distant metastasis will be calculated as the cumulative incidence of first local relapse and first distant metastasis, respectively.|from baseline up to 15 years|All patients that were eligible and received treatment were analyzed.|||years||Full Range|Median
1297431|NCT00041119|Secondary|Adverse Events|To compare toxicities of short course CA and paclitaxel with long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer. The percentage of patients that received a grade 3 or higher hematologic event will be reported here. We will be combining arm I with arm III, as well as arm II with arm IV. For a complete list of adverse events, please refer to the adverse events section.|from baseline up to 6 weeks post-treatment|3754 patients were considered evaluable for toxicity that occurred during treatment.|||percentage of patients|||Number
1297432|NCT00041119|Secondary|Overall Survival (OS)|To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for overall survival. OS will be measured from study entry until death due to any cause. Survivors will be censored at the date of last follow-up.. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis.|from baseline up to 5 years|All patients that were eligible and treated for the study were evaluated.|||percentage of participants at 5 years|||Number
1297433|NCT00041119|Primary|Duration of Disease Free Survival (RFS)|To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival. Objective progression is defined as the appearance of local (chest wall, axillary, supraclavicular nodes) or distant metastases. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis.|from baseline up to 6.4 years|All eligible patients were treated and analyzed.|||months||95% Confidence Interval|Median
1297434|NCT00041119|Primary|Relapse Free Survival (RFS) 4 vs. 6 Cycles|To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for relapse-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.|from baseline up to 4 years|All patients that were eligible and received treatment were analyzed. 700 patients were not included due to the timing that the analysis was performed.|||years||Full Range|Median
1297435|NCT00041080|Primary|Median Progression-free Survival||from enrollment onto the study until first disease progression or death due to any cause||||months||95% Confidence Interval|Median
1297436|NCT00041067|Secondary|Toxicity|Number of patients for whom highest grade of toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.|toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession|Eligible patients|||Participants|||Number
1297437|NCT00041067|Secondary|Progression-free Survival||2 years|All eligible patients|||months||95% Confidence Interval|Median
1297438|NCT00041067|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Response was measured by the RECIST criteria. A patient was considered a responder if there was confirmed or unconfirmed partial or complete response. All others were considered non-responders even if the patient was technically not assessable due to different measurement techniques at the two time points.|response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession|patients with Response Evaluation Criteria in Solid Tumors measurable disease|||participants|||Number
1297439|NCT00041067|Primary|Survival at 1 Year||1 year|All eligible patients|||percentage of patients||95% Confidence Interval|Number
1297440|NCT00040937|Primary|Overall Survival||4-7 years||||proportion surviving at 4 years||95% Confidence Interval|Number
1297441|NCT00040937|Secondary|Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.|To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.|Induction|All participants receiving at least one dose of induction therapy|||Participants|||Number
1297442|NCT00040846|Secondary|Evaluate the Risk for Disease Progression and Relapse|Percentage patients who relapsed/progressed within 1 year post-transplant.|1 year after transplant||||percentage of participants|||Number
1297443|NCT00040846|Secondary|Evaluate the Risk/Incidence of Infections|Percentage patients who experienced infections within 100 days post-transplant.|100 days after transplant||||percentage of participants|||Number
1297444|NCT00040846|Primary|Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.|Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells.|100 days after transplant||||percentage of participants|||Number
1297445|NCT00040846|Primary|Evaluate the Risk of Occurrence of Acute and Chronic GVHD|"Percentage patients who developed acute/chronic GVHD.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|1 year after transplant||||percentage of participants|||Number
1297446|NCT00040846|Primary|Evaluate the Risk of Transplant Related Mortality.|Percentage patients with Day 100 transplant related mortality.|100 days after transplant||||percentage of participants|||Number
1297447|NCT00040742|Secondary|Average Nausea Severity|"Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings.~Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure.~Negative values for this outcome are favorable."|3-4 days on study drug|Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.|||units on a scale||Standard Error|Mean
1297448|NCT00040742|Primary|Change From Baseline of Peak Acute Nausea|"Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings.~Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure.~Negative values for this outcome are favorable."|3-4 days on study drug|Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.|||units on a scale||Standard Deviation|Mean
1297449|NCT00039377|Secondary|5 Year Overall Survival for Autologous & Allogeneic Transplant Groups|Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.|5 years from registration|Participants who were on autologous or allogeneic transplant arms were analyzed (N=34).|||percentage of patients||95% Confidence Interval|Number
1297450|NCT00039377|Secondary|5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups|Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.|5 years from CR|Participants who received autologous or allogeneic transplants were analyzed (N=34)|||percentage of patients||95% Confidence Interval|Number
1297451|NCT00039377|Primary|Disease Free Survival|"Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.~A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month."|Duration of treatment (up to 10 years)|One participant was excluded per study design as they did not achieve a complete remission. DFS Analysis was powered to include all patients.|||years||95% Confidence Interval|Median
1297452|NCT00039377|Secondary|Number of Participants Who Achieved a BCR-ABL Response at 12 Months|"BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).~Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene~MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally)."|12 months|Peripheral blood stem cells were assayed from 13 patients.|||participants|||Number
1297453|NCT00039377|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|OS Analysis was powered to include all participants.|||years||95% Confidence Interval|Median
1297454|NCT00039195|Primary|Progression Free Survival|Kaplan-Meier estimates will be used to verify the progression free survival.|2 years||||percentage of patients progression free||95% Confidence Interval|Number
1297455|NCT00039130|Secondary|2 Year Overall Survival|Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|2 years||||percentage of participants||95% Confidence Interval|Number
1297456|NCT00039130|Secondary|2 Year Event Free Survival|Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure.|2 years||||percentage of participants||95% Confidence Interval|Number
1297457|NCT00039130|Primary|Complete Response Rate|Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.|6 months||||percentage of participants||95% Confidence Interval|Number
1297458|NCT00036738|Secondary|Transplant-related Mortality|Number of patients with TRM within one year post-transplant.|At 1 year||||Participants|||Count of Participants
1297459|NCT00036738|Secondary|Transplant-related Mortality|Number of patients with TRM within 100 days post-transplant.|At day 100||||Participants|||Count of Participants
1297460|NCT00036738|Secondary|Overall Survival|Number of patients surviving up to five years post-transplant.|Assessed up to 5 years||||Participants|||Count of Participants
1297464|NCT00033657|Secondary|Overall Survival Time|Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients.|Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|Eligible, treated patients|||Months||95% Confidence Interval|Median
1297465|NCT00033657|Primary|Pathologic Complete Response Rate|A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.|approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|Eligible, treated patients|||percentage of participants||90% Confidence Interval|Number
1297466|NCT00033631|Secondary|Normal Tissue Complication Probability||From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.||2018-06-30|06/2018||||
1297467|NCT00033631|Secondary|Tumor Control Probability||From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.||2018-06-30|06/2018||||
1297468|NCT00033631|Secondary|Quality Adjusted Survival by SQLI|This analysis will not be done because there was no difference in survival between the two treatment arms.|From randomization to 5 years.|||||||
1297469|NCT00033631|Secondary|Global Quality of Life (QOL) by Spitzer QOL Index (SQLI)||From randomization to 5 years.|||||||
1297470|NCT00033631|Secondary|Erectile Function by International Index of Erectile Function (IIEF)||From randomization to 5 years.|||||||
1297471|NCT00033631|Secondary|Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity|Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0|From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint|Eligible patients with acute adverse event data who did not withdraw consent.|||percentage of participants|||Number
1297472|NCT00033631|Secondary|Distant Metastases|Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who have not withdrawn consent|||percentage of participants||95% Confidence Interval|Number
1297473|NCT00033631|Secondary|Local Progression|Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who have not withdrawn consent|||percentage of participants||95% Confidence Interval|Number
1297474|NCT00033631|Secondary|Disease Specific Survival|Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.|From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
1297475|NCT00033631|Secondary|Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition|Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.|From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.|All eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
1297476|NCT00033631|Primary|Overall Survival|Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.|All eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
1297477|NCT00033540|Secondary|Median Survival Time for Participants With Relevant Biologic Markers|To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.|All patients will be followed until death or three years after registration, whichever is first.|Eligible patients who received genotyping were included in this analysis.|||months||95% Confidence Interval|Median
1297478|NCT00033540|Secondary|Accrual of Patients With This Disease Site|Only eligible patients who received treatment were evaluable for response and survival outcomes.|1-20 months|Patients with advanced disease accrued between September 2003 to April 2005|||participants|||Number
1297495|NCT00033293|Secondary|Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology|Descriptive analyses on biologic variables will be performed|At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis|The data is not available at this time. Investigators have not finished analyzing the specimens or reviewing the patient study data required to evaluate this study objective.||||||
1297479|NCT00033540|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.|Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1297480|NCT00033540|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|All patients will be followed until death or three years after registration, whichever is first.|All eligible patients who started treatment were included in assessing response estimates.|||months||95% Confidence Interval|Median
1297481|NCT00033540|Primary|Response|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Patients assessed at least every six weeks while on protocol treatment|All eligible patients who started treatment were included in assessing response estimates.|||participants|||Number
1297482|NCT00033514|Primary|Recommended Dose for Phase II||treatment period|patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.|||participants receiving each dose|||Number
1297483|NCT00033514|Secondary|Serum Concentration of Herceptin at Specified Time-points.||4 months||||mcg/mL||95% Confidence Interval|Mean
1297484|NCT00033514|Secondary|Incidence of Adverse Events||5 years|subjects evaluated for SAEs|||participants affected by SAEs|||Number
1297485|NCT00033514|Secondary|Duration of Objective Response||5 years|Subjects that achieved objective response (4). All were from phase II.|||participants|||Number
1297486|NCT00033514|Primary|The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.|"Complete Response:~The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.~Partial Response:~A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission."|5 years|12 patients with measurable disease and no prior trastuzumab in the metastatic setting considered evaluable at the recommended phase II dose level. 2 from phase 1 and 10 from phase 2 Excluded : 14 from Phase I: no measureable disease or previous trastuzumab. Phase II: Withdrawn due to disease complications|||participants|||Number
1297487|NCT00033371|Secondary|Percent Change in the Area of Plaque-like Duodenal Polyps|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment|||||||
1297488|NCT00033371|Secondary|Change in Global Colorectal Polyp Burden|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment|||||||
1297489|NCT00033371|Secondary|Percent Change in Polyp Size in Focal Area(s) of the Colorectum|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment|||||||
1297490|NCT00033371|Secondary|Global Duodenal Polyp Burden|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Up to 2 months after completion of study treatment|||||||
1297491|NCT00033371|Primary|Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum|Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie [(6 months - baseline) x 100]/baseline (%). For each participant, first were matched polyps between baseline & 6 months by region and landmark and summed over all matched regions on number of polyps >2 mm to calculate total number of polyps >2 mm at baseline & 6 months, respectively. For participants refusing exit colonoscopy, 0% change entered as primary endpoint. Defined ITT All: All patients; if 6-month polyp counts missing = 0% change; ITT Measurable: All participants with baseline & 6 month polyp counts; ITT Evaluable: ITT Measurable participants who also took 80% of treatment, both overall as well as during final 60 days.|Baseline up to 6 months|Analysis was by intent to treat (ITT) with a total of 89 ITT participants measurable by having complete polyp information.|||percentage change in polyp count||Standard Error|Mean
1297492|NCT00033293|Secondary|Tumor Outcome in Terms of Overall Survival (OS) Rate|OS rate from time of study enrollment.|Up to 3 years|All eligible randomized patients.|||3 year OS||95% Confidence Interval|Number
1297493|NCT00033293|Secondary|Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death|EFS rate for neuroblastoma event from time of study enrollment.|Up to 3 years|All eligible randomized patients.|||3 year EFS||95% Confidence Interval|Number
1297494|NCT00033293|Secondary|Long-term Prognosis for Neurologic Recovery by Neurological Examination|A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.|At diagnosis and yearly for 10 years after diagnosis|The data is not available at this time. Investigators have not finished analyzing the specimens or reviewing the patient study data required to evaluate this study objective.||||||
1297496|NCT00033293|Secondary|Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing|"The Bayley Scales of infant development mental scale best score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline."|Changes from baseline to the better of 6 months or 1 year|All eligible patients who had Bayley's measures at diagnosis and at least one of 6 months or 1 year.|||Change in Bayley's score||Standard Deviation|Mean
1297497|NCT00033293|Secondary|Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)|"The best score at the two time points will be used in this analysis. For a given patient, this best score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated."|Changes from baseline to the better of 6 months or 1 year|All eligible patients who had VABS measures at diagnosis and at least one of 6 months or 1 year.|||Change in VABS score||Standard Deviation|Mean
1297498|NCT00033293|Primary|Number of Responders|A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.|Changes from baseline to 2 months, 6 months, and 1 year|Eligible patients|||participants|||Number
1297499|NCT00031694|Secondary|Bryostatin 1 Pharmacokinetics||Week 1|||||||
1297500|NCT00031694|Secondary|Overall Survival|Computed using the Kaplan-Meier estimator.|Up to 8 years|||||||
1297501|NCT00031694|Secondary|Adverse Events|95% confidence intervals will be computed and presented.|Up to 8 years|||||||
1297502|NCT00031694|Primary|Response Rate of at Least 30%|Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 8 years||||participants|||Number
1297503|NCT00030901|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|3 months after randomization and then every 3 months for 3 years|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1297504|NCT00030901|Primary|Presence of Carcinoma of the Prostate as Measured by Biopsy|The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.|3 years|All eligible randomized patients who started treatment and have prostate cancer known through an interim biopsy or a biopsy taken at +/- 90 days of the end of study were included in the analysis.|||participants|||Number
1297505|NCT00030823|Primary|Safety|By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.|2 years|All 13 participants experienced toxicities.|||participants|||Number
1297506|NCT00030264|Primary|Time to Disease Progression|"Disease progression was assessed both radiographically and clinically.~Tumor assessments to assess for radiographic disease progression were assessed by magnetic resonance imaging (MRI) measurement whenever possible or computed tomography (CT) scan and/or tumor measurement during physical examination of palpable lesions. Clinical assessments for clinical progression of disease were assessed by treating physician or designee.~Progressive disease as measured by the appearance of new lesions; an increased size of index tumor(s) by >/= 25% of the sum of the products of baseline measurements; and/or by increase in symptoms."|6 months|20 subjects were analyzed for time to progression. 3 subjects were not included in the response analysis due to lost to follow up (N=2) or progression of comorbid condition which required early termination (N=1)|||Months||Full Range|Mean
1297507|NCT00028769|Primary|Overall Survival (OS)|Overall survival is defined from the date of registration to date of death from any cause|0-5 years|All eligible patients who started treatment were included in the analysis|||months||95% Confidence Interval|Median
1297508|NCT00028769|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 5 years after registration|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1297509|NCT00028769|Primary|Progression-free Survival|Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of >=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.|0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)|All eligible patients who started treatment were included in the analysis|||months||95% Confidence Interval|Median
1297524|NCT00027560|Primary|Overall Survival||24 months post transplant|Population is defined as all participants who received transplant as per protocol.|||participants|||Number
1297525|NCT00027560|Primary|Overall Survival||12 months post transplant|Population is defined as all participants who received transplant as per protocol.|||participants|||Number
1297510|NCT00028002|Secondary|FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy|"evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax <1 indicate decreased tumor metabolism while values >1 indicated an increase in tumor metabolism.~Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD."|change from baseline to 1 week post therapy||||percentage change in SUVmax||Full Range|Mean
1297511|NCT00028002|Secondary|Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)|Highest grade toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity, using Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.|Analysis occurs after all patients have been on study for at least 2 years. Measured from start of treatment to end of follow-up, to a maximum of 4.95 years.|All eligible patients who started study treatment (for pre-surgery), and who additionally had surgery (post-surgery)|||percentage of participants||95% Confidence Interval|Number
1297512|NCT00028002|Secondary|Rates of Objective Response (Complete, Partial, and Stable)|The percentage of patients who achieved a complete, partial or stable response prior to surgery as assessed by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf.|Pretreatment and prior to surgery (at 4-10 weeks, based on surgery timing)|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1297513|NCT00028002|Primary|Rate of Disease Progression at 2 Years|Kaplan-Meier estimate of disease progression rate. Disease progression is determined by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf|From registration to two years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1297514|NCT00027846|Secondary|Local Control and Patterns of Failure|Documented and analyzed qualitatively and quantitatively.|Up to 5 years after completion of study treatment|All eligible patients in the study were included.|||Participant|||Number
1297515|NCT00027846|Secondary|Event-free Survival (EFS)|EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.|At 5 years since the time of radiation therapy|Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.|||Probability of EFS at 5 years||95% Confidence Interval|Number
1297516|NCT00027846|Secondary|Event-free Survival (EFS)|EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.|At 5 years since the time of radiation therapy.|Of 64 eligible patients who had initial subtotal resection, 5 patients were off-therapy prior to radiation therapy, and 4 patients had a disease progression prior to radiation therapy. There were 55 eligible patients included in the analysis. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.|||Probability of EFS at 5 years||95% Confidence Interval|Number
1297517|NCT00027846|Secondary|Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy|The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.|At the time of second surgery|Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%.|||percentage of participants||95% Confidence Interval|Number
1297518|NCT00027846|Secondary|Overall Survival|Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.|Up to 5 years after completion of study treatment|All eligible patients in the study were included. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability.|||Probability of OS at 5 years||95% Confidence Interval|Number
1297519|NCT00027846|Primary|Event-free Survival|Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.|Up to 5 years after completion of study treatment|The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included.|||Probability of EFS at 5 years||95% Confidence Interval|Number
1297520|NCT00027560|Secondary|Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients||up to 2 years post transplant|The number of unrelated and mismatched patients was analyzed as per protocol.|||participants|||Number
1297521|NCT00027560|Secondary|Extensive Chronic Graft-versus-Host Disease Matched Related Patients||up to 2 years post transplant|The number of matched related patients was analyzed as per protocol.|||participants|||Number
1297522|NCT00027560|Secondary|Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients|Grade III-IV Acute Graft-versus-Host Disease|up to 4 months post transplant|The number of unrelated and mismatched patients was analyzed as per protocol.|||participants|||Number
1297523|NCT00027560|Primary|Acute Graft-versus-Host Disease Matched Related Patients|Grade III-IV Acute Graft-versus-Host Disease|up to 4 months post transplant|The number of matched related patients was analyzed as per protocol.|||participants|||Number
1297527|NCT00026312|Other Pre-specified|Presence of Naturally Occurring Anti-glycan Antibodies|A Fisher’s exact test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions. A Wilcoxon test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with blood levels of dinutuximab.|Up to 10 years|||||||
1297528|NCT00026312|Other Pre-specified|NKp30 Isoform Expression and SNP|Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of NKp30 isoform expression and SNP, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of NKp30 isoform expression and SNP, adjusting for significant prognostic factors including v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) status, INSS stage, histology and age at diagnosis.|1 week before first sargramostim injection (day -1 of course 1)|||||||
1297529|NCT00026312|Other Pre-specified|Levels of ADCC|Will be descriptively compared.|Up to 10 years|||||||
1297530|NCT00026312|Other Pre-specified|Isotretinoin Pharmacokinetic Parameters|To determine if there is a relationship of the peak serum concentration level with EFS, the term for this level will be tested in a Cox proportional hazards model. To determine if there is a relationship of the peak serum concentration level with toxicity rates, Kendall’s Tau statistic will be calculated.|At 4 hours after administration on day 14 of course 1|||||||
1297531|NCT00026312|Other Pre-specified|Genotype of Kir/Kir-ligand|Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.|Up to 10 years|||||||
1297532|NCT00026312|Other Pre-specified|Genotype of FcR|Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.|Up to 10 years|||||||
1297533|NCT00026312|Other Pre-specified|Circulating B7-H6 Levels|Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of circulating B7-H6 level, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of circulating B7-H6 level, adjusting for significant prognostic factors including MYCN status, INSS stage, histology and age at diagnosis.|1 week before first sargramostim injection (day -1 of course 1)|||||||
1297534|NCT00026312|Other Pre-specified|Change in Tumor Biology|A multivariate Cox proportional hazards regression model will test to see if the dinutuximab serum level, HACA titer, effector cell function, or serum marker for effector cell activation are associated with EFS or OS.|Baseline to up to 10 years|||||||
1297535|NCT00026312|Other Pre-specified|Change in MRD|A descriptive analysis of the change from baseline of MRD will be performed. Also, a Wilcoxon rank-sum test will be performed to compare the median change from baseline of MRD between the two treatment arms. A multivariate Cox proportional hazards regression model will test to see if the change in MRD burden is associated with EFS or OS.|Baseline to up to 10 years|||||||
1297536|NCT00026312|Other Pre-specified|Cardiac Repolarization|In general, descriptive summaries will include n, mean, standard deviation, median, minimum, maximum and 90% confidence intervals for continuous variables, and n and percent for categorical variables. Summaries will present data by assessment time when appropriate.|Up to 10 years|||||||
1297537|NCT00026312|Other Pre-specified|Average Level of HACA|The average level of HACA at each collection time point during immunotherapy will be calculated.|Up to 10 years|||||||
1297538|NCT00026312|Secondary|Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial|OS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.|Three years|Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease|||Percentage of participants||95% Confidence Interval|Number
1297539|NCT00026312|Secondary|Overall Survival (OS)|Comparison to determine if RA + Immunotherapy improves OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease.|Three years|Eligible, randomized patients. Eligible, randomized patients with INSS Stage 4 disease.|||Percentage of participants||95% Confidence Interval|Number
1297540|NCT00026312|Secondary|Number of Courses of Therapy Delivered|Number of courses of therapy delivered for patients randomized to RA + Immunotherapy vs. patients non-randomly assigned to RA + Immunotherapy, excluding patients with persistent disease.|Courses 1-6|Eligible patients assigned to Regimen B, excluding patients with persistent disease.|||courses per patient||Full Range|Median
1297541|NCT00026312|Secondary|Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0|Proportion of patients experiencing at least one Grade 3 or higher toxicity.|From enrollment to follow-up|Eligible patients enrolled prior to halting of randomization.|||Proportion||95% Confidence Interval|Number
1297542|NCT00026312|Secondary|Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial|EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.|Three years|Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease.|||Percentage of participants||95% Confidence Interval|Number
1297543|NCT00026312|Secondary|Event-Free Survival (EFS)|Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981.|Three years|Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.|||Percentage of participants||95% Confidence Interval|Number
1297544|NCT00026312|Primary|Event-Free Survival (EFS)|Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only|Three years|Eligible, randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1297545|NCT00026221|Secondary|New Vessel Formation in Patient Tumor Samples|Evaluated using immunohistochemistry.|Up to 2 years|Data were not collected and not assessed.||||||
1297547|NCT00026221|Primary|Progression-free Survival|Defined as the time from treatment start date until documentation of progressive disease. Evaluated using the new international criteria proposed by the RECIST Committee. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years||||months||Full Range|Median
1297548|NCT00026221|Other Pre-specified|Toxicity|Evaluated using the National Cancer Institute (NCI) Common Toxicity Criteria version 2.0.|Continuously from the start of treatment to the end of study|||||||
1297549|NCT00026221|Primary|Objective Response Rate|Measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 2 years||||patients|||Number
1297550|NCT00026208|Secondary|Survival at 5 and 10 Years|Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints.|5 and 10 years|For overall survival at 5 and 10 years, this analysis does not include those participants known to be alive, but whose diagnosis was less than 5 or 10 years prior to current date or last date known alive, respectively.|||Participants|||Count of Participants
1297551|NCT00026208|Secondary|Overall Survival (OS)|Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation.|16 years|Includes all participants, except those whose treatment was significantly modified due to accidental injury. Subjects who became lost-to-follow-up were censored at their last known value.|||years||Full Range|Median
1297552|NCT00026208|Secondary|Second Hodgkin's Disease Progression|Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis.|16 years|Data to confirm Hodgkin's disease 2nd progression was not available for some participants.|||Participants|||Count of Participants
1297553|NCT00026208|Secondary|Late Treatment-related Toxicity|Late treatment-related toxicity was assessed as the overall number of late-appearing toxicities (ie, related adverse events, after treatment completion) including but not limited to diagnosis of a 2nd cancer; hypothyroidism; infertility; pulmonary toxicity; or cardiac toxicity, at up to 16 years from date of diagnosis.|16 years||||treatment-related adverse events|||Number
1297554|NCT00026208|Secondary|Early Treatment-related Toxicity|Early treatment-related toxicity was assessed as the number of treatment-related, non-serious adverse events that occurred during treatment or within 30 days of the completion of treatment.|Within 30 days of treatment||||treatment-related adverse events|||Number
1297555|NCT00026208|Secondary|Frequency of Complete Response|"The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as complete regression of all palpable and radiographic demonstrable disease by computed tomography (CT) scan or positron emission tomography-CT (PET-CT)."|5 weeks|Participants, for whom a PET-CT scan was not conducted in week 4 to 5 of treatment, were not included.|||Participants|||Count of Participants
1297556|NCT00026208|Primary|Progression-free Survival (PFS)|Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.|up to 3 years|Does not include those participants whose treatment was significantly modified due to accidental injury; or who were lost-to-follow-up.|||percentage of participants|||Number
1297557|NCT00025662|Other Pre-specified|Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.||100 days from transplant|All 22 patients who received the selectively depleted transplant|||percentage of participants|||Number
1297558|NCT00025662|Other Pre-specified|Acute GVHD (Any Grade) Using the CIBMTR Grading System.|Proportion of patients with acute GVHD, grade 1 to 4|100 days from transplant|All 22 subjects who received the selectively depleted transplant|||percentage of participants||95% Confidence Interval|Number
1297559|NCT00025662|Secondary|Cumulative Non Relapse Mortality|Percent non relapse mortality (actuarial) at analysis in Dec 2011|Dec 2011.|All patients who received the selectively depleted transplant|||percentage of participants||95% Confidence Interval|Number
1297560|NCT00025662|Secondary|Overall Survival|Percent overall survival (actuarial) at analysis in Dec 2011.|Dec 2011.|all patients who received the selectively depleted transplant including one special exemption|||percentage of participants||95% Confidence Interval|Number
1297561|NCT00025662|Primary|Treatment-related Mortality|"Nonrelapse mortality in the first 100 days of transplant expressed as a percentage of the total subjects.~This is different from outcome measure 3 (Cumulative Nonrelapse Mortality), which is cumulative non relapse mortality till December 2011."|100 days after stem cell infusion|all 22 patients who received a selectively depleted allogeneic transplant, including one who was a special exemption for not meeting full eligibility criteria|||percentage of participants||95% Confidence Interval|Number
1297562|NCT00025506|Other Pre-specified|Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF||Up to 5 years|||||||
1297563|NCT00025506|Other Pre-specified|Serum and Plasma Concentrations of VEGF and bFGF With PFS||Up to 5 years|||||||
1297564|NCT00025506|Secondary|Initial Histologic Grade|G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.|Baseline|Eligible and evaluable patients|||Participants|||Count of Participants
1297565|NCT00025506|Secondary|Initial Performance Status|"Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction.~Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.~Performance status 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours."|baseline|Eligible and evaluable patients|||Participants|||Count of Participants
1297567|NCT00025506|Secondary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1297568|NCT00025506|Secondary|Progression Free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle until progression or death, up to 5 years.|Eligible and treated patients|||months||Inter-Quartile Range|Median
1297569|NCT00025506|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0||Each cycle during treatment and 30 days after the last treatment (average 4 months)|Eligible and evaluable patients|||Participants|||Count of Participants
1297570|NCT00025506|Primary|Progression-free Survival (PFS) > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for 6 months|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1297571|NCT00025259|Secondary|Overall Survival|Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.|5 years|Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).|||Probability of survival||95% Confidence Interval|Number
1297572|NCT00025259|Secondary|Grade 3 or 4 Non-hematologic Toxicity|Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.|Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).|||Number of participants|||Number
1297573|NCT00025259|Secondary|Disease Response Assessed by Modified RECIST Criteria|Number of participants with complete response and very good partial response at the end of protocol therapy.|Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).|||Number of participants|||Number
1297574|NCT00025259|Primary|Event-free Survival|Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.|5 years|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).|||Probability of survival||95% Confidence Interval|Number
1297575|NCT00025233|Secondary|Age at Enrollment||Baseline|Eligible and treated patients|||Participants|||Count of Participants
1297576|NCT00025233|Secondary|Performance Status|Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Baseline|Eligible and treated patients.|||Participants|||Count of Participants
1297577|NCT00025233|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1297578|NCT00025233|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
1298806|NCT00023595|Secondary|H02: LVEF by CMR Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.|From randomization to 24 months follow-up|Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
1297579|NCT00025233|Secondary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months)|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1297580|NCT00025233|Primary|Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0|The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.|Every cycle and 30 days after the end of treatment. (average 5 months)|Eligible and treated patients|||Participants|||Count of Participants
1297581|NCT00025233|Primary|Progression-free Survival Greater Than 6 Months|Whether or not the patient survived progression-free for at least 6 months.|Every other 3-week treatment cycle for 6 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1297582|NCT00025155|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated participants.|||Months||95% Confidence Interval|Median
1297583|NCT00025155|Secondary|Progression Free Survival|"Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first.~Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression."|From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up|Eligible and treated participants.|||Months||95% Confidence Interval|Median
1297584|NCT00025155|Primary|Number of People With Adverse Effects||Every cycle until completion of study treatment up to 30 days after stopping study treatment|Eligible and treated patients|||Participants|||Count of Participants
1297585|NCT00025155|Primary|Tumor Response|"Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval.~Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation."|Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.|Eligible and treated participants.|||percentage of participants||90% Confidence Interval|Number
1297586|NCT00024258|Primary|Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment||1 year||||participants|||Number
1297587|NCT00024167|Secondary|Overall Survival From Registration|Overall survival (OS) was computed using the number of months from the date of registration to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.|Followed every 4 weeks from registration until death, up to 7 years.||||months||95% Confidence Interval|Median
1297588|NCT00024167|Primary|Overall Survival From Randomization|Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.|Followed every 4 weeks from randomization until death, up to 7 years.||||months||95% Confidence Interval|Median
1297589|NCT00024102|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity.~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Reported during protocol treatment after each cycle||||participants|||Number
1297590|NCT00024102|Secondary|Overall Survival Rate at 2.4 Years|Percentage of patients who were alive at 2.4 years. This rate was estimated using the Kaplan Meier method.|Time from registration to death (up to 15 years)|OS used the intent-to-treat approach.|||percentage of participants|||Number
1297591|NCT00024102|Primary|Relapse-free Survival Rates at 2.4 Years|"Percentage of participants who were alive and relapse-free at time of analysis were counted as Alive without relapse at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as relapse, first occurrence. These rates were estimated using the Kaplan Meier method"|randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)|RFS used the intent-to-treat approach|||percentage of participants|||Number
1297592|NCT00023764|Primary|Response Rate|The response probability will be estimated. The 95% confidence interval will be provided.|Up to 3 years||||participants|||Number
1297643|NCT00021255|Secondary|Overall Survival- Percentage of Participants Who Survived at 10 Years|Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.|From randomization until death or up to 10 years|ITT population.|||percentage of particpants||95% Confidence Interval|Number
1297593|NCT00023712|Secondary|Progression-Free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|From study entry up to 5 years||||months||95% Confidence Interval|Median
1297594|NCT00023712|Secondary|Overall Survival||From study entry, up to 5 years following disease progression||||months||95% Confidence Interval|Median
1297595|NCT00023712|Primary|Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD.|From study entry until disease progression/intolerable toxicity/study withdrawal||||participants|||Number
1297596|NCT00023712|Primary|Frequency and Severity of Observed Adverse Events||Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
1297597|NCT00023712|Primary|Tumor Response Duration|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|From study entry, up to 5 years||||months||Full Range|Median
1297598|NCT00022698|Secondary|Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths|An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.|Approximately 43 Months|The Safety Population consisted of all participants who received at least 1 dose of any study drug and had at least one post-baseline safety assessment. This included participants in Cohort 1 and Cohort 2.|||Number of participants|||Number
1297599|NCT00022698|Secondary|Duration of Overall Complete Response|The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.|||months|||Number
1297600|NCT00022698|Secondary|Duration of Overall Response|Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.|||months||95% Confidence Interval|Median
1297601|NCT00022698|Secondary|Time To Objective Response|The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||months||95% Confidence Interval|Median
1297602|NCT00022698|Secondary|Overall Survival|Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||months||95% Confidence Interval|Median
1297603|NCT00022698|Secondary|Percentage of Participants With One-year Survival|Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.|Up to Month 12|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||percentage of participants||95% Confidence Interval|Number
1297604|NCT00022698|Secondary|Time to Treatment Failure|Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||months||95% Confidence Interval|Median
1297605|NCT00022698|Secondary|Time to Disease Progression|Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||months||95% Confidence Interval|Median
1297606|NCT00022698|Primary|Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)|Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||percentage of participants|||Number
1297607|NCT00022672|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.|Throughout the Study (Up to 5 years)|Safety population included all participants who received at least one dose of study drug.|||Participants|||Number
1297608|NCT00022672|Secondary|Percentage of Participants With Best Tumor Response at End of Study|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.|End of Study (Up to 5 years)|Full Analysis Population includes all randomized participants who received study drug.|||Percentage of participants|||Number
1297609|NCT00022672|Secondary|Percentage of Participants With Overall Tumor Response at End of Study|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.|End of Study (Up to 5 years)|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.|||Percentage of participants|||Number
1297610|NCT00022672|Secondary|Time to Response at End of Study|Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.|End of Study (Up to 5 years)|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.|||Months||Full Range|Median
1297611|NCT00022672|Secondary|Duration of Response at End of Study|Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.|End of Study (Up to 5 years)|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.|||Months||Full Range|Median
1297612|NCT00022672|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline|"Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.~The percentage of participants in the following categories:~Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline."|Baseline, Final Visit (Up to 24 Months)|Participants from the Full Analysis Population (includes all randomized participants who received study drug) with data available for analyses.|||Percentage of participants|||Number
1297613|NCT00022672|Secondary|Percentage of Participants With Best Tumor Response at 24 Months|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.|24 Months|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.|||Percentage of participants|||Number
1297614|NCT00022672|Secondary|Percentage of Participants With Overall Tumor Response at 24 Months|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.|24 Months|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.|||Percentage of participants|||Number
1297615|NCT00022672|Secondary|Percentage of Participants With Two-Year Survival||24 Months|Full Analysis Population included all randomized participants who received study drug.|||Percentage of participants|||Number
1297616|NCT00022672|Secondary|Overall Survival at 24 Months|Overall Survival is defined as the number of days from randomization to death.|24 Months||||Months||95% Confidence Interval|Median
1297617|NCT00022672|Secondary|Time to Response at 24 Months|Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.|24 Months|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.|||Months||Full Range|Median
1297618|NCT00022672|Secondary|Duration of Response at 24 Months|Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.|24 Months|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.|||Months||Full Range|Median
1297619|NCT00022672|Secondary|Percentage of Participants With Clinical Benefit|Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.|24 Months, End of Study (Up to 5 years)||||Percentage of participants|||Number
1297620|NCT00022672|Primary|Progression Free Survival (PFS)|PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.|24 Months, End of Study (Up to 5 years)|Full analysis population included all randomized participants who received study drug.|||Months||95% Confidence Interval|Median
1297621|NCT00022659|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years.|Eligible and treated patients|||months||Inter-Quartile Range|Median
1297622|NCT00022659|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
1297623|NCT00022659|Primary|Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.||Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years.|Eligible and evaluable patients|||Participants|||Count of Participants
1297624|NCT00022659|Primary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1297625|NCT00022659|Primary|Progression-free Survival at 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for 6 months.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1297626|NCT00022633|Secondary|Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||percentage of participants|||Number
1297627|NCT00022633|Secondary|Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||minutes||Full Range|Median
1297695|NCT00012298|Primary|Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)|Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.|Assessed up to week 24|All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.|||participants|||Number
1297628|NCT00022633|Secondary|Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||percentage of participants|||Number
1297629|NCT00022633|Primary|Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols|Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.|66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)|A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.|||participants|||Number
1297630|NCT00022633|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.|Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded|||Participants|||Number
1297631|NCT00022633|Secondary|Overall Survival (OS) in Patients Aged 70 Years and Older|Measured from date of registration to date of death due to any cause.|0-5 years|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||months||95% Confidence Interval|Median
1297632|NCT00022633|Secondary|Progression-free Survival in Patients Aged 70 Years and Older|Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.|0-5 years|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||months||95% Confidence Interval|Median
1297633|NCT00022633|Secondary|Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)|Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.|every week for the first 4 weeks and then every 3 weeks for up to 19 weeks|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1297634|NCT00022516|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention-to-treat (N=1081 patients)|||percentage of participants||95% Confidence Interval|Number
1297635|NCT00022516|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention-to-treat (N=1081 patients)|||percentage of participants||95% Confidence Interval|Number
1297636|NCT00022516|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates, reported at a median follow-up of 6.9 years|Intention to treat (N=1081 patients)|||percentage of participants||95% Confidence Interval|Number
1297637|NCT00022516|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention to treat (N=1081 patients)|||percentage of participants||95% Confidence Interval|Number
1297638|NCT00022490|Secondary|The Rate of Complete Hematologic Responses at 6 and 12 Months||6 and 12 months|||||||
1297639|NCT00022490|Secondary|The Rate of Minor Cytogenetic Responses at 6 and 12 Months||6 and 12 months|||||||
1297640|NCT00022490|Secondary|The Rate of Complete and Major Cytogenetic Responses at 12 Months||12 months|||||||
1297641|NCT00022490|Secondary|The Rate of Complete Cytogenetic Response at 6 Months||6 months|||||||
1297644|NCT00021255|Secondary|Percentage of Participants With Disease Free Survival at 10 Years|Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.|From randomization until relapse or death or up to 10 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
1297645|NCT00021255|Primary|Percentage of Participants With Disease Free Survival at 5 Years|Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.|From randomization until relapse or death or up to 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
1297646|NCT00021229|Secondary|Pre-treatment Vascular Endothelial Growth Factor Values From Plasma|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma VEGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study.|||pg/ml||Standard Error|Mean
1297647|NCT00021229|Secondary|Pre-treatment Vascular Endothelial Growth Factor From Urine|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine VEGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study.|||pg/ml||Standard Deviation|Mean
1297648|NCT00021229|Secondary|Pre-treatment Basic Fibroblast Growth Factor Values From Plasma|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma bFGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study.|||pg/ml||Standard Deviation|Mean
1297649|NCT00021229|Secondary|Pre-treatment Basic Fibroblast Growth Factor Values From Urine|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine bFGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study.|||pg/ml||Standard Deviation|Mean
1297650|NCT00021229|Secondary|Median Overall Survival|Overall Survival (OS) is defined as the interval from initiation of treatment to death or date of last contact for surviving patients.|Assessed before radiation therapy, before the first dose of imatinib, then every 8 weeks.|The analysis population consists of the stratum I participants who received imatinib mesylate at or above the maximum tolerated dose. The median survival reported is based on these 20 participants.|||Days||95% Confidence Interval|Median
1297651|NCT00021229|Secondary|Peak Concentration (Cmax)|Peak concentration (cmax) is a pharmacokinetic measure defined as the highest concentration of a drug measured after the drug is administered. The cmax of imatinib mesylate on day 1 of course 1 is reported. Two milliliter (0.5 ml for children under the age of 5) blood samples were collected immediately prior to imatinib mesylate administration on Day 1 of Course 1 and at the following timepoints following drug administration: 0.5, 1, 1.5, 2, 4, 10 and 12 hours after the morning dose.|Day 1 of Course 1|The analysis population consists of participants who enrolled at the maximum tolerated dose (MTD) of the phase I component and who submitted day 1 course 1 samples for the PK studies. An MTD was not estimated in stratum IIB. For this stratum, reported are values at the stratum IIA MTD to allow comparison.|||µg/ml||Full Range|Mean
1297652|NCT00021229|Secondary|Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of radiation (RT) on changes in various neuroimaging variables in pediatric brainstem gliomas (stratum I). Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline (pre-radiation) and within two (+/- one) weeks after completion of RT.|Baseline and two weeks post completion of radiation|The analysis population consists of Stratum I patients enrolled who had both pre and post radiation (RT) volume FLAIR measures. Stratum II participants did not receive RT and thus were not included.|||cubic centimeters||Full Range|Mean
1297653|NCT00021229|Primary|Median Progression-free Survival (PFS)|Progression-free survival is defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.|Assessed pre-radiation, before the first dose of imatinib, and then every 8 weeks|Per protocol, 40 participants who received at least one dose of drug were needed for this objective. The analysis population consists of stratum I participants enrolled at the maximum tolerated dose (phase 1) and the participants enrolled to the phase II part. The study was terminated because of poor accrual and the objective was not met.||||||
1297725|NCT00006721|Primary|Progression-free Survival at 2 Years|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||percentage of participants|||Number
1298816|NCT00023595|Secondary|H01: All-cause (Unplanned and Elective) Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1297654|NCT00021229|Primary|Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy|The dose limiting toxicity (DLT) analysis population consisted of phase I stratum II participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the DLT analysis population of 20 in stratum IIA was 465 mg/m2/day. An MTD was not established in stratum IIB as no DLTs were observed at the higher dose levels of 620 and 800 mg/m2/day.|Day 1 of Imatinib Mesylate Therapy to Week 8|Per protocol, participants included phase I stratum II participants who developed dose-limiting toxicities (DLT) during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs.|||Participants|||Number
1297655|NCT00021229|Primary|Number of Participants in Phase I Stratum I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy|The dose limiting toxicity (DLT) analysis population consists of phase I stratum I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the 23 participants who either had a DLT during course 1 or 2 or completed courses 1 and 2 without DLT is 265 mg/m2/day.|Day 1 of Imatinib Mesylate Therapy to Week 8|Per protocol, participants included phase I stratum I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.|||Participants|||Number
1297656|NCT00020722|Secondary|Overall Survival||Length of time from day of transplant until death.|Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.||||||
1297657|NCT00020722|Primary|Disease-free Survival||Length of time from day of transplant until recurrence or relapse.|Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.||||||
1297658|NCT00019747|Primary|Time to Progression|Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|62 months|The analysis was not done because there were not enough subjects to do any of the statistical analyses.||||||
1297659|NCT00019682|Secondary|Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)|QOL was measured before and after 2 cycles of treatment using 4 measures: FACT-G is a 27 item measure of QOL. A total score is calculated by summing across responses on a 5 point scale and ranges from 0-135, with higher scores indicating better QOL. FACT-F is 13 item measure of fatigue. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 0-52, with higher scores indicating less fatigue. SF-36 is a 36 item measure of self-reported health status. SF-36 is comprised of 8 subscales: physical function, role physical, bodily pain vitality, role emotional function, mental health, social function and general health. Summated scores range from 0-100, with higher scores indicating a better health state. SDS is a 13 item measure of symptom distress. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 13 to 65, with higher scores indicating more symptom distress.|Baseline to up to 8 weeks||||units on a scale||Standard Error|Mean
1297660|NCT00019682|Secondary|Change in T-cell Precursors|To measure change in T-cell precursors, PBMC were tested for reactivity by measuring gamma-interferon release after overnight coculture with peptide pulsed T2 cells. PBMC obtained after 4 cycles of study treatment were compared to pre treatment PBMC. A positive assay was defined as greater than 100pg/ml gamma-interferon release and at least twice the release (including all control peptides) by post treatment PBMC compared to pre treatment PBMC.|Baseline to up to 12 years|All patients with paired cryopreserved peripheral blood lymphocytes obtained before any treatment and after completing 4 cycles of treatment.|||Participants with a positive assay|||Number
1297661|NCT00019682|Secondary|Progression Free Survival|Progression free survival was compared between groups by means of Kaplan-Meier curves using the log-rank test to evaluate the significance of the difference between the arms.|From the date of randomization until documentation of progression or last follow up, assessed up to 12 years||||months||95% Confidence Interval|Median
1297662|NCT00019682|Primary|Best Response Rate (Partial Response [PR] + Complete Response [CR])|A complete response (CR) was defined as the disappearance of all clinical evidence of disease for at least 4 weeks. A partial response (PR) was defined as a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions could appear, and none could increase 25% or more.|Up to 12 years||||Participants|||Count of Participants
1297663|NCT00019604|Secondary|Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)|PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
1297726|NCT00006478|Secondary|Changes in Quantitative Bcl-2|To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.|1 year post transplant evaluation and then annually until disease progression|The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.||||||
1297664|NCT00019604|Secondary|Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms|Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., <median change, >median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
1297665|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers|Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
1297666|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies|Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
1297667|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)|Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
1297668|NCT00019604|Secondary|Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)|Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
1297669|NCT00019604|Secondary|Tumor Vascular Density|Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.|Baseline, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
1297670|NCT00019604|Secondary|Tumor Blood Flow|Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.|Baseline, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
1297671|NCT00019604|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|9 years, 9 months|NA is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but the format is uninterpretable.|||Participants|||Number
1297672|NCT00019604|Primary|Response|Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.||The time frame for this outcome measure is unknown; the investigator left the institution and there is no available data. We only have access available on 23 participants. We cannot comment on the others or verify because we do not have the data.|||Participants|||Number
1297673|NCT00017563|Primary|Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.|Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.|Every 3 months after surgery for up to 5 years.||||participants|||Number
1297674|NCT00016913|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.|registration to progression, up to 5.5 years from registration|All 27 evaluable patients were used in this analysis|||months||95% Confidence Interval|Median
1297727|NCT00006478|Secondary|Toxicity|To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting|At each immunization and at study completion|The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.||||||
1297675|NCT00016913|Secondary|Time to Prostate-specific Antigen Failure|PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.|PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).|All 27 evaluable patients were used in this analysis.|||months||95% Confidence Interval|Median
1297676|NCT00016913|Primary|Toxicity|Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at >90 days after the completion of radiotherapy.|90 days and 1 year post treatment|Final analyses were performed on all 27 eligible patients.|||Events|||Number
1297677|NCT00016354|Secondary|Test for Antitumor Activity in Blood and Tissue||baseline|||||||
1297678|NCT00016354|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU||8 weeks|||||||
1297679|NCT00016354|Secondary|Number of Patients With Adverse Events||every 4 weeks|||||||
1297680|NCT00016354|Primary|Determine Maximum Tolerated Dose of BPU|Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays >2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting <5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.|4 weeks (1 course of treatment for each subject)|Participants that completed at least 1 cycle of BPU.|||milligrams (mg)|||Number
1297681|NCT00015847|Primary|Major Cytogenetic Response After 6 and 12 Months of Treatment.|"Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:~Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%).~*Major cytogenetic response includes complete and partial cytogenetic response."|6 and 12 months after treatment||||Participants|||Number
1297682|NCT00015847|Primary|Treatment-related Toxicity (i.e., Grade 3 or 4 Nonhematologic Toxicity) as Measured by NCI CTCAE v3.0 (Phase I)|1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death|12 Months||||Participants|||Number
1297683|NCT00015847|Primary|Molecular Response in Patients With Complete Cytogenetic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II|||||||
1297684|NCT00015847|Primary|Complete Hematologic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II|||||||
1297685|NCT00015847|Primary|Minor Cytogenetic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II|||||||
1297686|NCT00015847|Primary|Complete Cytogenetic Response at 6 and 12 Months (Phase II)|"Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:~Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%)."|At 6 and 12 months during phase II||||Participants|||Number
1297687|NCT00014495|Primary|Maximum Tolerated Dose|The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.|2 years||||mCi/kg|||Number
1297688|NCT00012298|Secondary|Tumor Response Rate (Phase II)|Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated.|Assessed up to 5 years|All eligible phase II patients. One of the 39 phase II patients was deemed ineligible|||percentage of patients with response||95% Confidence Interval|Number
1297689|NCT00012298|Secondary|Time to Disease Progression (Phase II)|Estimated using the method of Kaplan-Meier.|From registration to the earliest date documentation of>disease progression, assessed up to 5 years|All eligible phase II patients. One out of the 39 phase II patients was deemed ineligible.|||years||95% Confidence Interval|Median
1297690|NCT00012298|Secondary|Survival (Phase II)|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|Phase II portion of the study. One patient out of the 39 was deemed ineligible and was not included in survival analysis.|||years||95% Confidence Interval|Median
1297691|NCT00012298|Secondary|Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)|Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times.|At week 12|Not collected. Study team decision not to analyze this endpoint.||||||
1297692|NCT00012298|Secondary|Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I)|Explored using a contingency table and sensitivity and specificity will be calculated using 90% exact confidence intervals.|At week 12|Not collected. Study team decision not to analyze this endpoint.||||||
1297693|NCT00012298|Secondary|Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I)|Assessed using a correlated logistic regression model and generalized estimating equations (GEE). Covariates such as dose level and use of prophylactic cytokines may also be included in this model. A Wilcoxon test will be used to assess the equality of the distributions of the continuous levels of predicted tumor radiation from the In2B8 scans by response.|At week 12|Not collected. Study team decision not to analyze this endpoint.||||||
1297694|NCT00012298|Primary|Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II)|Estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.|At 3 years|Forty-five patients were registered to Dose Level 6 (39 patients registered to the Phase II portion and 6 patients registered to Dose Level 6 in the Phase I portion). Of the 45 patients, 33 patients received 2 sequential doses of Y2B8 and were evaluable for this endpoint.|||proportion of participants||95% Confidence Interval|Number
1297696|NCT00012298|Primary|Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)|"This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly.~> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event.~> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here."|At 8 weeks|DLTs were determined in the second cycle of combined treatment. Only Phase I patients that were evaluated after 2 cycles of treatment are included in this evaluation. Two patients at Dose Level 1, 1 patient at Dose Level 2, 4 patients at Dose Level 3, and 1 patient at Dose Level 5 were not evaluated for MTD.|||Patients reporting Dose-Limiting Events|||Number
1297697|NCT00012012|Secondary|Distant Metastases||From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
1297698|NCT00012012|Secondary|Pelvic Tumor Control||From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
1297699|NCT00012012|Primary|Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)|The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%.|From start of treatment to 90 days|All eligible patients|||participants|||Number
1297700|NCT00012012|Primary|Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)|To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study.|From start of treatment to 90 days|All eligible patients|||percentage of participants||95% Confidence Interval|Number
1297701|NCT00011986|Primary|Frequency and Severity of Observed Adverse Effects Assessed by Common Toxicity Criteria Version 2.0||Up to 9 years|||||||
1297702|NCT00011986|Primary|Progression-free Survival|Median duration in months of progression free survival.|From the date of enrollment to first progression or death or last contact, if alive and progression free.||||months||95% Confidence Interval|Median
1297703|NCT00011986|Primary|Overall Survival||Up to 9 years|||||||
1297704|NCT00010257|Secondary|Duration of Response|Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria|assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Number of participants achieving a complete or partial response by RECIST criteria|||Months||95% Confidence Interval|Median
1297705|NCT00010257|Primary|Best Overall Response by RECIST Criteria (Version 1.0)|Number of eligible, treated participants in each response category by RECIST criteria|Assessed every 2 cycles (6 weeks)|Analysis population included all eligible participants who received at least 1 dose of the protocol treatment|||Participants|||Number
1297706|NCT00009945|Secondary|Incidence of Non-skeletal Metastasis|Time from randomization to incidence of non-skeletal metastasis to determine the percentage of patients free from non-skeletal metastasis at 8 years|8 years||||percentage of patients|||Number
1297707|NCT00009945|Secondary|Relapse Free Survival|Time from randomization to any local, regional, or distant recurrence of breast cancer to determine the percentage of patients relapse free at 8 years|8 years||||percentage of patients|||Number
1297708|NCT00009945|Secondary|Overall Survival|Time from randomization to any death to determine the percentage of patients alive at 8 years|8 years||||percentage of patients|||Number
1297709|NCT00009945|Secondary|Skeletal Metastasis Free Survival|Time from randomization to first diagnosis of skeletal metastasis to determine the percentage of patient free of skeletal metastasis at 8 years|8 years||||percentage of patients|||Number
1297710|NCT00009945|Primary|Disease Free Survival.|Time to first event where an event is any recurrences, 2nd primary or death to determine the percentage of patients disease free at 8 years|8 years||||percentage of patients|||Number
1297711|NCT00008385|Secondary|5-year Overall Survival Rate|Overall survival (OS) was defined as the time from randomization to death due to any cause. Cases without death had been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year OS rate.|Assessed annually for 5 years after randomization|All randomized patients|||proportion of participants||95% Confidence Interval|Number
1297712|NCT00008385|Secondary|5-year Progression-free Survival Rate|"Progression-Free Survival (PFS) was defined as the time from randomization to second primary lung cancer or recurrence. Cases without events have been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year PFS rate.~Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer.~Different histologic type~Location in different lobe~Location in contralateral lung~Occurrence > 5 years after initial diagnosis"|Assessed annually for 5 years after randomization|All randomized patients|||proportion of participants||95% Confidence Interval|Number
1297713|NCT00008385|Primary|Incidence Rate of Second Primary Lung Tumor|Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.|Assessed annually for 10 years after randomization|all randomized patients|||cases/100 person years|||Number
1297714|NCT00008138|Primary|Progression-Free Survival|Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment. Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.|Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.|Only eligible patients were included in the analysis.|||months||95% Confidence Interval|Median
1297715|NCT00008138|Primary|Overall Survival|Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.|assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5|Only eligible patients were included in the analysis.|||months||95% Confidence Interval|Median
1297716|NCT00006916|Primary|Overall Survival|This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.|||||||
1297717|NCT00006903|Secondary|Number of Participants With Grade 3 or Greater Toxicity by Common Toxicity Criteria Version 3.0 That Were at Least Possibly Related to Study Drug.|Adverse events at least possibly related to Fulvestrant using Common Terminology Criteria version 3.0 that were grade 3 or higher with the exception of the reported Grade 5. Grade 5 adverse events were reported regardless of attribution to study treatment.|During study treatment and up to 30 days after stopping study|Eligible and evaluable patients.|||Participants|||Count of Participants
1297718|NCT00006903|Primary|Clinical Response by RECIST Criteria of Estrogen Receptor Expression|Per response evaluation criteria in Solid Tumors Criteria (RECIST 1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >=30% decrease in the sum of the longest diameter of target lesions. Overall Response = CR+PR|Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months.|Total number eligible and treated participants within groups defined by estrogen receptor status|||Participants|||Count of Participants
1297719|NCT00006903|Primary|Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks|"Primary outcome measured according to RECIST v1.0 Best Response:~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.|Total number eligible and treated participants within groups defined by estrogen receptor status in metastatic tumor.|||participants|||Number
1297720|NCT00006721|Primary|Overall Survival at 5 Years|Measured from date of registration to date of death due to any cause|0-5 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||percentage of participants|||Number
1297721|NCT00006721|Primary|Overall Survival at 2 Years|Measured from date of registration to date of death due to any cause|0-2 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||percentage of participants|||Number
1297722|NCT00006721|Primary|Progression-free Survival at 5 Years|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-5 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||percentage of participants|||Number
1297723|NCT00006721|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal|Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included|||Participants|||Number
1297724|NCT00006721|Secondary|Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||participants|||Number
1297728|NCT00006478|Secondary|Safety|To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting|At each immunization and at study completion|The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.||||||
1297729|NCT00006478|Primary|Number of Participants With Humoral and Cellular Immune Response|evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation|immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression|NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series.||||||
1297730|NCT00006392|Secondary|Number of Participants With Serious Cardiovascular Events|Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.|||participants|||Number
1297731|NCT00006392|Secondary|Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival|Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. Deaths include those reported as SAEs as well as non-SAE deaths as this was a prevention trial with older generally healthy men at baseline who were followed for a long time.|||participants|||Number
1297732|NCT00006392|Secondary|Number of Participants With Any Diagnosis of Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.|||participants|||Number
1297733|NCT00006392|Secondary|Number of Participants With Colorectal Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.|||participants|||Number
1297734|NCT00006392|Secondary|Number of Participants With Lung Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.|||participants|||Number
1297735|NCT00006392|Primary|Number of Participants With Prostate Cancer|Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.|Every six months for 7 to 12 years depending on when the participant was randomized.|All randomized eligible men not at 2 sites for which the DSMC said the data could not be used due to participant and data management issues as well as regulatory problems.|||participants|||Number
1297736|NCT00006389|Secondary|Progression-free Survival|Progression-free survival was estimated according to the Kaplan-Meier product-limit method|18 months||||months||95% Confidence Interval|Median
1297737|NCT00006389|Secondary|Overall Survival|Overall survival was estimated according to the Kaplan-Meier product-limit method.|18 months||||Months||95% Confidence Interval|Median
1297755|NCT00005879|Primary|Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months|"Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist.~Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia."|Baseline to 6 months|Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in cytomorphology category.|||Participants|||Count of Participants
1297756|NCT00005879|Primary|Change in Masood Score|"Change in the semi-quantitative score assigned by the designated cytopathologist.~Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4."|Baseline to 6 months|Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in Masood score.|||units on a scale||Standard Deviation|Mean
1297738|NCT00006389|Primary|Observed Response Rate.|"All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 “target lesions” were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference~The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval."|Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.|The first 15 patients accrued to an Optimal Three-Stage Phase II design. If 3 or more responses are seen then 18 additional evaluable patients will be accrued to the second stage.|||Percentage of Participants||95% Confidence Interval|Number
1297739|NCT00006244|Secondary|Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity|Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.|First 100 days post-transplant|Of the 36 patients, 16 patients were ≥56 years old and these 16 are used to determine this outcome measure.|||Participants|||Count of Participants
1297740|NCT00006244|Secondary|Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity|Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.|First 100 days post-transplant|Of the 36 patients, 20 patients were <56 years old and these 20 patients are used to determine this outcome measure.|||Participants|||Count of Participants
1297741|NCT00006244|Primary|Proportion of Patients Alive and in Remission||12.9 Median Years||||Participants|||Count of Participants
1297742|NCT00006244|Primary|Time to Disease Progression||12.9 years (median)|Out of 36 patients, 30 have relapsed and they are used to determine this outcome measure.|||years||Full Range|Median
1297743|NCT00006244|Primary|Initial Response to Therapy|Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)|Evaluated at Day +84-90 Post-Transplant||||Participants|||Count of Participants
1297744|NCT00006244|Primary|Overall Survival|Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.|12.9 Median Years||||Participants|||Count of Participants
1297745|NCT00006237|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.|Eligible patients who started therapy|||Participants|||Number
1297746|NCT00006237|Primary|5-year Relapse-Free Survival|Measured from date of registration to date of first observation of progressive disease or death due to any cause.|Every three months for the first year, every 6 months for years 2-5, annually for years 6-10||||Percentage of population|||Number
1297747|NCT00006237|Primary|5-year Overall Survival|Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.|Every three months for a year, every six months for years 2-5, annual for years 5-10||||Percent of population|||Number
1297748|NCT00006110|Secondary|Disease-free Survival (DFS) in Patients Receiving and Not Receiving Herceptin®.|Percent of patients receiving and not receiving Herceptin who are alive and disease-free at 5 years.|5 years||||percentage of patients|||Number
1297749|NCT00006110|Secondary|Overall Response|Measured by the Overall Response. Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|78 weeks (1.5 years)|Protocol specifies that Response will be examined in patients who were treated neoadjuvantly. Because of this, only patients treated with Herceptin neoadjuvantly and non-Herceptin patients were included in this analysis. One patient was found unevaluable in the AC-P group and was not included in the analysis.|||Participants|||Count of Participants
1297750|NCT00006110|Primary|Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.|Doxorubicin + cyclophosphamide in combination with paclitaxel and trastuzumab (AC-TP) Associated Systolic Dysfunction. Systolic function was measured by the ventricular ejection fraction (LVEF). LVEF is a measurement in determining how well your heart is pumping out blood and in diagnosing and tracking heart failure.|78 weeks (1.5 years)|LVEF data during AC-TP are complete on 50 patients. 2 are incomplete because of withdrawal (1) and progressive disease (1). 43 of the 52 patients underwent LVEF determination at 1.5 years.|||Participants|||Count of Participants
1297751|NCT00006101|Primary|Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months|Difference refers to absolute difference of 12 months to baseline and % relative difference refers to the ratio of the absolute difference divided by the baseline times 100.|Baseline and 12 months|The results reported include all men with both an entrance and exit biopsy, regardless of cancer status.|||Relative % difference||Standard Deviation|Mean
1297752|NCT00006011|Primary|Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.|"Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion.~Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization.~Intention to treat among eligible participants who receive random treatment allocation."|study entry up to 5 years post treatment||||participants|||Number
1297753|NCT00005957|Secondary|Disease-free Survival|Disease-free survival (including locoregional and distant disease)|10 years|Intention-to-treat|||percentage of disease-free at 10 years||95% Confidence Interval|Number
1297754|NCT00005957|Primary|Overall Survival|Duration of study|10 years|Intention-to-treat|||percentage of alive at 10 years||95% Confidence Interval|Number
1297757|NCT00005803|Secondary|Progression Free-survival (PFS)|Number of patients surviving without disease by interval. Chemosensitive and chemoresistant subjects will be analyzed separately.|From the date of autologous transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission, assessed up to 3 years|One patient who counted to accrual is not included here. They received conditioning for autologous transplant, but then did not receive the transplant.|||Participants|||Count of Participants
1297758|NCT00005803|Secondary|Overall Survival (OS)|Number of patients surviving by interval. Chemosensitive and chemoresistant subjects will be analyzed separately.|From the date of autologous transplant until the time of death, assessed up to 3 years|One patient who counted to accrual is not included here. They received conditioning for autologous transplant, but then did not receive the transplant.|||Participants|||Count of Participants
1297759|NCT00005803|Primary|Non-Relapse Mortality|"The rates and accompanying confidence intervals associated with transplant-related mortality will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess failure rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease)."|Day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autografting|Although 54 patients received both auto transplant & allo transplant, one patient did not survive to day 100.|||Participants|||Count of Participants
1297760|NCT00005803|Primary|Engraftment of HLA Identical PBSC Allografts|"Number of patients who engrafted by Day 56 post allogeneic transplant. Failure to engraft is defined as the absence of detectable donor cells in the marrow. The rates and accompanying confidence intervals associated with failure of engraftment at day +56 will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess failure rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease)."|Day 56|Only includes patients who received allo transplant. One patient is excluded because they did not survive long enough to test for engraftment.|||Participants|||Count of Participants
1297761|NCT00005047|Secondary|Probability of Overall Survival|Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of survival were based on the Kaplan-Meier product-limit method.|5 years|This analysis compares p53 positive patients (combined arms I, II, and IV) to p53 negative patients (arm III).|||probability||Standard Error|Median
1297762|NCT00005047|Secondary|Probability of Recurrence|"Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations.~Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care."|5 years|This analysis compares p53 positive patients (combined arms I, II, and IV) to p53 negative patients (arm III).|||probability||Standard Error|Median
1297763|NCT00005047|Secondary|Probability of Overall Survival|p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Survival is calculated from registration to death due to any cause. Probabilities of survival were based on the Kaplan-Meier product-limit method.|5 years||||probability||Standard Error|Median
1297764|NCT00005047|Primary|Probability of Recurring|"p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Time from registration to the first observation of disease recurrence, censoring patients who died of unrelated causes. Probabilities of recurring were based on cumulative incidence curves.~Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care."|5 years||||probability||Standard Error|Median
1297765|NCT00005044|Secondary|Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)|Acute drug therapy and radiation (<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with adverse event data in corresponding time frame (during hormone therapy and <=90 days from RT start; > 90 days from RT start)|||percentage of participants|||Number
1297766|NCT00005044|Secondary|Time to Second Biochemical Failure (SBF) (10-year Rates Reported)|Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1297767|NCT00005044|Secondary|Time to First Biochemical Failure (BF) (10-year Rates Reported)|"Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored.~Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported."|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1297791|NCT00004143|Secondary|Overall Survival|Number of patients alive 2 years after transplant|2 years||||participants|||Number
1297768|NCT00005044|Secondary|Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)|Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF [protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1297769|NCT00005044|Secondary|Disease-free Survival (DFS) (10-year Rates Reported)|Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients without follow-up data|||percentage of participants||95% Confidence Interval|Number
1297770|NCT00005044|Secondary|Overall Survival (OS) (10-year Rates Reported)|Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1297771|NCT00005044|Primary|Disease-specific Survival (DSS) (10-year Rates Reported)|Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
1297772|NCT00004888|Secondary|Duration of Response|Defined as time from onset of PR or CR, whichever occurred first, until objective evidence of progression.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|Responders|||Months||95% Confidence Interval|Median
1297773|NCT00004888|Primary|Summary of Left Ventricular Ejection Fraction Values|This table summarizes the LVEF information at baseline, post Cycle 4, post Cycle 8, and 30 or more days after Cycle 8 on all treated patients and on the eligible subset. LVEF drops reported are absolute (not relative) drops.|Baseline, after cycle 4, after cycle 8, and 30 or more days after last cycle of induction therapy.|All treated patients|||LVEF percent||Standard Deviation|Mean
1297774|NCT00004888|Secondary|Progression-Free Survival|Progression-Free Survival was defined as time from study entry to progression or to death without documentation of progression. A progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|All eligible patients were included in this analysis. Please note that 2 patients on Arm B died without documentation of progression. Also, 4 patients died or were taken off treatment before follow-up evaluations, and PFS was censored at zero.|||months||95% Confidence Interval|Median
1297775|NCT00004888|Secondary|Overall Survival||Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|All eligible patients were included in this analysis.|||months||95% Confidence Interval|Median
1297776|NCT00004888|Secondary|Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.|Please note that overall response includes CR and PR. CR is defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. PR is greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. No change is defined as no significant change in measurable or evaluable disease for at least 4 weeks. Progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of Nov 21, 2007 is used for this report. Please note that best overall response is reported in the table.|Eligible Patients|||participants|||Number
1297777|NCT00004888|Primary|Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event|This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) >=10% but <20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF >=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.|Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy|Treated patients who had a cardiotoxicity event|||participants|||Number
1297778|NCT00004859|Primary|Overall Survival Time|Survival time is defined as time from study entry to death from any cause|every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5|intent to treat analysis in the 546 eligible patients|||Months||95% Confidence Interval|Median
1297836|NCT00003659|Secondary|Overall Survival Status|The 5 year survival rate. The survival of patients with this disease is dependent on the stage of disease. Two useful staging systems are: Three-stage Rai System Clinical Feature and the Binet System.|up to 5 years|All assessable patients as indicated in the protocol.|||participants|||Number
1297779|NCT00004859|Secondary|Response Rate at Best Response to Treatment|Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.|every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year||||Proportion of participants||95% Confidence Interval|Number
1297780|NCT00004859|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year||||Months||95% Confidence Interval|Median
1297781|NCT00004259|Secondary|(Phase III) Correlation of Molecular Analyses With Overall Survival and Time to Tumor Progression||From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.||2019-09-30|09/2019||||
1297782|NCT00004259|Secondary|(Phase III) Number of Patients With Grade 3 or Higher Toxicity|Adverse events were graded using CTCAE v2.0. Grade refers to the severity of the AE. The CTCAE v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The number of patients with grade or higher toxicity was calculated overall and for non-hematologic toxicity only. Per the protocol, the pilot arms were not included in the Phase III analyses.|From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.|Eligible randomized patients who started study treatment|||participants|||Number
1297783|NCT00004259|Secondary|(Phase III) Time to Tumor Progression (TTP)|Three-year rate is reported. Progression is defined as a radiographic increase in size of the lesion by > 25%, recurrence of the study lesion, or the development of new lesions, confirmed by imaging. Time to tumor progression was estimated using the cumulative incidence function (CIF) on tumor progression, with death as a competing risk. Per the protocol, the pilot arms were not included in the Phase III analyses.|From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.|Eligible randomized patients|||months||95% Confidence Interval|Median
1297784|NCT00004259|Primary|(Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms|Adverse events were graded using CTCAE v2.0. Grade refers to the severity of the adverse event (AE). The CTCAE v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Dose limiting toxicity (DLT) was defined as grade 3+ pulmonary toxicity, grade 4+ thrombocytopenia (< 25,000 for 5 days), neutropenia (< 500/microl for 7 days), or neutropenia of any duration with fever requiring hospital admission after one dose reduction of 50% in BCNU. A 20% rate of grade 3+ pulmonary toxicities or a 40% rate of grade 4+ thrombocytopenia and neutropenia was considered unacceptable for a treatment arm combining RT, TMZ, and BCNU.|From start of treatment to 3 months|Eligible patients who started study treatment on Pilot Arms 1 and 2|||Participants|||Count of Participants
1297785|NCT00004259|Primary|(Phase III) Overall Survival (OS)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Per the protocol, the pilot arms were not included in the Phase III analyses.|From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.|Eligible randomized patients|||years||95% Confidence Interval|Median
1297786|NCT00004228|Secondary|Percentage of Patients With Overall Survival as Assessed by Time to Death|Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.|5 years|There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.|||percentage of participants||95% Confidence Interval|Number
1297787|NCT00004228|Primary|Event-free Survival|Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.|5 years|There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.|||percentage of particpants||95% Confidence Interval|Number
1297788|NCT00004143|Primary|Number of Participants With Transplant-related Mortality|Number of patients who died due to transplant-related complications|100 days||||participants|||Number
1297789|NCT00004143|Primary|Number of Participants With Grade 3-4 Unexpected Adverse Events|An unexpected adverse event is one that differs in the nature, severity, or frequency from (a) the research procedures that are described in the protocol-related documents, (such as the IRB-approved research protocol and informed consent document) as expected, and/or (b) the characteristics of the subject population being studied.|45 days post transplant||||participants|||Number
1297790|NCT00004143|Primary|Number of Patients With Grade 3-4 Acute Graft Versus Host Disease (GVHD)|Number of patients with Grade 3-4 acute Graft Versus Host Disease (GVHD). GVHD will be monitored at least two times per week through day 45, then weekly through day 60 and graded by 2 persons at each institution, to ensure internal consistency in grading.|60 days post transplant||||participants|||Number
1297792|NCT00004143|Primary|Number of Patients With Platelet Engraftment|Number of patients with platelet engraftment - Platelets > 20,000/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity < 5%, peripheral White Blood Count (WBC) < 500/μL, peripheral ANC < 100/μL, and/or platelets < 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).|1 year post transplant||||participants|||Number
1297793|NCT00004143|Primary|Number of Patients With Neutrophil Engraftment|Number of patients with neutrophil engraftment: Absolute Neutrophil Count (ANC) > 500/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity < 5%, peripheral White Blood Count (WBC) < 500/μL, peripheral ANC < 100/μL, and/or platelets < 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).|1 year post transplant||||participants|||Number
1297794|NCT00004124|Secondary|PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival||Up to 10 Years|Data not collected for analysis.||||||
1297795|NCT00004124|Secondary|PSA Progression Free Survival|Measured from date of randomization to date of PSA progression or death due to any cause. PSA progression is defined as a serum PSA level of > 0.2 ng/mL measured on 3 consecutive occasions or in the absence of increasing PSA, a positive bone scan result or other radiographic or histologic evidence of progression will be used. Date of progression will be the date that the first measure of increasing PSA is noted in the series of 3.|Up to 10 Years|Data for trial not collected for analysis.||||||
1297796|NCT00004124|Secondary|Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients|Number of patients with adverse events that are related to study drug|Up to 22 months from registration|All eligible patients who received protocol therapy|||Participants|||Number
1297797|NCT00004124|Primary|Disease Free Survival|Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact.|at 10 Years|Intent-to-treat|||percentage of probability of survival|||Number
1297798|NCT00004124|Primary|Overall Survival|Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.|at 10 Years||||percentage of probability of survival|||Number
1297799|NCT00004092|Secondary|Five-Year Overall Survival|Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.|Five Years||||percentage of participants||95% Confidence Interval|Number
1297800|NCT00004092|Primary|Five-Year Relapse-free Survival|RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.|Five years||||percentage of participants||95% Confidence Interval|Number
1297801|NCT00004054|Secondary|Disease-free Survival Rate at 5 Years|Disease-free survival (DFS) was measured from the date of randomization to the date of documentation of progression (local, distant, biochemical failure), death, or last follow-up (censored). The Kaplan-Meier method was used to estimate DFS rates.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.|All randomized patients|||percentage of participants||95% Confidence Interval|Number
1297802|NCT00004054|Secondary|Rate of Distant Metastasis at Five Years|Distant metastasis (DM) is defined as documented metastatic disease. Time to distant metastasis is defined as time from randomization to distant metastatic disease, last known follow-up (censored), or death (competing risk). Distant metastasis rates are estimated using the cumulative incidence method.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.|All randomized patients|||percentage of participants||95% Confidence Interval|Number
1297803|NCT00004054|Secondary|Rate of Local Progression at 5 Years|Local progression is defined as documented clinical local and/or regional progression. Time to local progression is defined as time from randomization to local progression, last known follow-up (censored), or death (competing risk). Local progression rates are estimated using the cumulative incidence method.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.|All randomized patients|||percentage of participants||95% Confidence Interval|Number
1297804|NCT00004054|Secondary|Rate of Biochemical Failure at 5 Years|Biochemical failure uses the American Society for Radiation Oncology (ASTRO) definition of prostate-specific antigen (PSA) rises on three consecutive occasions, with biochemical failure date being midway between the last non-rising PSA and the first rise in PSA. Time to biochemical failure is defined as time from randomization to biochemical failure, last known follow-up (censored), or death (competing risk). Biochemical failure rates are estimated using the cumulative incidence method.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.|All randomized patients|||percentage of participants||95% Confidence Interval|Number
1297805|NCT00004054|Primary|Overall Survival (5-year Rate Reported)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years.|From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.|All randomized patients.|||percentage of participants||95% Confidence Interval|Number
1297806|NCT00003910|Secondary|Clinical Response||Assessed during the first 4 months of treatment and followed until reaching full study stop date|||||||
1297837|NCT00003659|Secondary|Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease|The flow cytometric response and the molecular polymerase chain reaction (PCR) response was captured as indicated in the protocol. Immunophenotypic analysis of bone marrow and/ or peripheral blood demonstrate a normal k:λ ratio and a normal number of CD5/CD19 (or CD5/CD20) dual staining cells (<5% of the lymphocyte gate).|3 years|All assessable patients as indicated in the protocol|||participants|||Number
1297807|NCT00003910|Primary|Complete, Partial, and Overall Response Rates of Treatment With MTX, and Also With CY for Patients Failing to Respond to MTX|We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% impr|Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.|Of the 59 pts, 4 were ineligible and excluded from the analysis.|||proportion of participants||95% Confidence Interval|Number
1297808|NCT00003901|Secondary|Disease-Free Survival in Bone Marrow Examined Patients|Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM|||years||95% Confidence Interval|Median
1297809|NCT00003901|Secondary|Disease-Free Survival in Lymph Nodes Examined Patients|Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants with N0 non–small-cell lung cancer who had underwent pulmonary resection and were examined for OM|||years||95% Confidence Interval|Median
1297810|NCT00003901|Primary|Overall Survival in Bone Marrow Examined Patients|Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM|||years||95% Confidence Interval|Median
1297811|NCT00003901|Primary|Overall Survival in Lymph Nodes Examined Patients|Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants with N0 non–small-cell lung cancer who had underwent pulmonary resection and were examined for OM|||years||95% Confidence Interval|Median
1297812|NCT00003896|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly during 6 weeks of protocol treatment|Paclitaxel/CDDP/Liposomal doxorubicin|||Participants|||Number
1297813|NCT00003896|Primary|Overall Survival|from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact|Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.|All eligible patients who began the treatment intervention.|||months||95% Confidence Interval|Median
1297814|NCT00003896|Primary|Progression-free Survival|From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.|Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.|Eligible patients who began the treatment intervention|||months||95% Confidence Interval|Median
1297815|NCT00003875|Secondary|Proportion of Patients Who Relapsed Associated With the Regimen||From date of transplant to date of death from any cause, assessed up to 178 months||||Participants|||Count of Participants
1297816|NCT00003875|Primary|Toxicity Associated With Aldesleukin Treatment After Stem Cell Rescue|Toxicity during IL-2 therapy of any of the following per NCI Common Toxicity version 3: grade 2, 3, 4, or 5 CNS (except grade 0-3 malaise, fatigue, anxiety and depression) toxicity; grade 3, 4, or 5 non-CNS or non-hematologic toxicity; any grade 4 or 5 hematologic toxicity.|IL-2 administration to one month after completion of IL-2 treatment|29 patients underwent autologous transplant and 21 of these patients after transplant went on to get IL-2 treatment . Toxicity for IL-2 therapy thus was only analyzed in these later 21 patients.|||Participants|||Count of Participants
1297817|NCT00003875|Primary|Toxicity Associated With High-dose Busulfan and Etoposide Followed by Stem Cell Rescue|Toxicity is defined as any grade 3 or grade 4 toxicity per the Bearman toxicity grading criteria following Busulfan and Etoposide high-dose chemotherapy, stem cell transplant, and the inability to recover sufficiently by day 100 to start IL-2 therapy.|Day -7 of transplant to 100 days post transplant||||Participants|||Count of Participants
1297818|NCT00003875|Primary|Overall Survival of Patients on Busulfan and Etoposide Followed by Stem Cell Rescue and Aldesleukin|Estimated by the method of Kaplan and Meier.|From date of transplant to date of death from any cause, assessed up to 178 months||||Participants|||Count of Participants
1297819|NCT00003869|Secondary|Number of Patients With a Confirmed Tumor Responses Treated With CAI.|"Confirmed response was defined as a complete response (CR) or partial response (PR) for patients with measurable disease or as a CR or regression (REGR) for patients with evaluable disease noted on 2 consecutive evaluations at least 4 weeks apart.~CR: total disappearance of all tumor;~PR: >=50% reduction of the sum of the products of the two greatest perpendicular diameters of all indicator lesions;~REGR: Definite decrease in tumor size and no new lesion(s)."|During Treatment (up to 5 years)|This data was not (and will never be) analyzed as it was not submitted consistently due to the trial design. (Patients were required to be SD or better to be randomized to carboxyamidotriazole or placebo.)||||||
1297838|NCT00003659|Primary|Overall Response Rate|Response was determined as indicated in the protocol. The categories are: complete response, nodular partial response, partial response and failure. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. The laboratory and radiographic studies which were abnormal pre-study, will be repeated to document the degree of maximal response.|3 years|There were 36 assessable patients as described in the protocol|||participants|||Number
1297820|NCT00003869|Secondary|Clinically Significant (10-point) Decrease in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Quality of Life (QOL)Assessment From Baseline to Week 8|The FACT-L is a 36-item Likert instrument that combines frequency of symptomatic/QOL problems with perceived relative importance of each issue. It includes 4 constructs of well being: physical, social/family, emotional and functional, and a fifth construct, additional concerns, dealing solely with tumor related symptoms. Questionnaires were completed at baseline and 8 weeks. Questions within each construct were summated to obtain a construct score. A higher score relates to higher quality of life. A 10 point or greater decline (from baseline to week 8) was considered clinically significant.|Baseline to week 8|Participants who completed the baseline and week 8 FACT-L assessment are included in the analysis.|||participants|||Number
1297821|NCT00003869|Secondary|Clinically Significant (10-point) Decrease in UNISCALE Quality of Life (QOL)Assessment From Baseline to Week 8|The UNISCALE was used to assess QOL. UNISCALE is a single item global measure of QOL. Participant were to complete the questionnaire at baseline and every 8 weeks, prior to assessment by the treating physician. A high score indicates a higher quality of life while a low score represents a lower quality of life. A 10 point or greater decline (from baseline to week 8) in UNISCALE QOL score was considered clinically significant.|Baseline to week 8|Participants who completed the baseline and week 8 UNISCALE assessment are included in the analysis.|||participants|||Number
1297822|NCT00003869|Secondary|Time to Disease Progression (TTP)|"TTP is defined as the time from randomization to first documented disease progression(PD). Patients who were lost to follow-up were censored at the time of last evaluation. For patients who died without clear documentation, PD was assumed at the midpoint of the time interval between last evaluation and death. Median TTP was estimated using the Kaplan Meier method.~Measurable PD: ≥25% increase in the sum of the products of two greatest perpendicular diameters of all indicator lesions or appearance of new lesion(s). Evaluable PD: definite increase in tumor size or appearance of new lesion(s)"|up to 5 years|TTP was analyzed on all randomized patients on an intent to treat basis.|||Months||95% Confidence Interval|Median
1297823|NCT00003869|Secondary|Participants With Severe Non-hematologic Adverse Events|Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC version 2.0)|every cycle during treatment|All treated participants; all participants who received study treatment.|||Participants|||Number
1297824|NCT00003869|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|Overall survival was analyzed on all randomized participants on an intent to treat basis.|||Months||95% Confidence Interval|Median
1297825|NCT00003820|Secondary|Overall Response Rate (ORR)|"Overall response as assessed as Complete Response (CR) + Partial Response (PR)~CR was determined as complete metabolic response (CMR), meaning complete resolution of 18-fluorodeoxyglucose (FDG) uptake within the tumor volume so that it is indistinguishable from surrounding normal tissue.~PR was determined as partial metabolic response (PMR), meaning reduction of greater than 25% in the standardized uptake value (SUV) adjusted for body surface area (SUV-BSA). A reduction in the extent of tumor FDG uptake is not required for PMR."|4 weeks|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.|||percentage of participants|||Number
1297826|NCT00003820|Secondary|Overall Survival (OS)|OS, assessed as the number of patients 5 years after treatment who are alive|5 years|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.|||participants|||Number
1297827|NCT00003820|Primary|Progression-free Survival (PFS)|PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion|5 years|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.|||participants|||Number
1297828|NCT00003782|Secondary|Amenorrhea in Premenopausal Women||baseline, 9 weeks, and 6, 12, 18, and 24 months|||||||
1297829|NCT00003782|Secondary|Quality of Life Among Breast Cancer Patients||baseline, 9 weeks, and 6, 12, 18, and 24 months|||||||
1297830|NCT00003782|Secondary|Toxicities Among the 3 Regimens||9 years|||||||
1297831|NCT00003782|Primary|Disease Free Survival||time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event|||||||
1297832|NCT00003782|Primary|Overall Survival||8 years||||percentage of patients alive|||Number
1297833|NCT00003702|Secondary|Number of Patients With a Decline of hCG on Day 1 of Treatment|Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start.|Prior to study entry and on Day 1 of treatment|Eligible and evaluated patients|||Participants|||Count of Participants
1297834|NCT00003702|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.|Eligible and treated patients|||Participants|||Count of Participants
1297835|NCT00003702|Primary|Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay|Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.|Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.|Eligible patients who received a random treatment allocation|||Participants|||Count of Participants
1297839|NCT00003641|Secondary|5-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients.|assessed every 3 months for 2 years, every 6 months for 3 years|all randomized patients|||proportion of participants||95% Confidence Interval|Number
1297840|NCT00003641|Primary|5-year Relapse-free Survival Rate|Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.|assessed every 3 months for 2 years, every 6 months for 3 years|all randomized patients|||proportion of participants||95% Confidence Interval|Number
1297841|NCT00003631|Primary|Objective Response|Determine the overall objective response. CR rate [as measured from the start of ICE, (or high dose CTX) to the end of transplant for those who receive it, or the end of ICE for those who do not].Complete response (CR): No evidence of Hodgkin's disease determined clinically, radiologically or pathologically when indicated|2 years||||participants|||Number
1297842|NCT00003590|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal|Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months|Eligible patients who had received any hydroxyurea were included in the adverse event summaries. Any CTC 2.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants with a given type of AE|||Number
1297843|NCT00003590|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed).|Patients treated for 2 years or progression. If responding can continue at physician's discretion.|All eligible patients who started treatment were included in assessing response estimates.|||Participants|||Number
1297844|NCT00003537|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297845|NCT00003537|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
1297846|NCT00003535|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy|||Percentage of Participants|||Number
1297847|NCT00003535|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
1297848|NCT00003483|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy|||Percentage of Participants|||Number
1297849|NCT00003483|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
1297850|NCT00003479|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of Participants|||Number
1297851|NCT00003479|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
1297852|NCT00003477|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297853|NCT00003477|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks. Stable Disease (SD): <50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
1297854|NCT00003476|Secondary|Percentage of Participants Who Survived|Six months and Twelve months overall survival|6 months, 12 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297855|NCT00003476|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
1297856|NCT00003475|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297857|NCT00003475|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
1297858|NCT00003474|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297859|NCT00003474|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
1297860|NCT00003473|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297861|NCT00003473|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
1297862|NCT00003472|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297863|NCT00003472|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
1297864|NCT00003471|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months||||Percentage of participants|||Number
1297865|NCT00003471|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
1297866|NCT00003470|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297867|NCT00003470|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
1297868|NCT00003469|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297869|NCT00003469|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
1297870|NCT00003468|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297871|NCT00003468|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks..|12 months||||Participants|||Number
1297872|NCT00003460|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297873|NCT00003460|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
1297874|NCT00003459|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297875|NCT00003459|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
1297876|NCT00003458|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297877|NCT00003458|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
1297878|NCT00003457|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297879|NCT00003457|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), < 50% decrease and < 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.|12 months||||Participants|||Number
1297880|NCT00003456|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
1297881|NCT00003456|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
1297882|NCT00003453|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months||||Percentage of participants|||Number
1297883|NCT00003453|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
1297884|NCT00003389|Secondary|Incidence of Second Cancers|Number of patients who developed second primary cancers|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years||||participants|||Number
1297885|NCT00003389|Secondary|5-year Overall Survival|Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years.|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years|Eligible patients|||Proportion of patients||95% Confidence Interval|Number
1297886|NCT00003389|Primary|Failure-free Survival at 5 Years|"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission."|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5|Eligible patients|||Proportion of patients||95% Confidence Interval|Number
1297887|NCT00003377|Secondary|Overall Survival at 2 Years|Product-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97)|2 years||||probability||95% Confidence Interval|Mean
1297888|NCT00003377|Secondary|Disease-free Survival at 2 Years|"Product-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86).~Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study."|2 years||||probability||95% Confidence Interval|Mean
1297889|NCT00003377|Primary|Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment||up to 21 weeks||||participants|||Number
1297890|NCT00003199|Secondary|Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF|IL-2/GM-CSF toxicity assessed using the NCI Toxicity Criteria. Toxicity was defined as any grade 2, 3, 4 or 5 CNS (except grade 0-3 malaise and fatigue) toxicity; any grade 3, 4, or 5 non-CNS or non-hematological toxicity (except grade 0-3 bilirubin); or any grade 4 or 5 hematological toxicity.|16 Weeks|28 (56%) of 50 patients started IL-2/GM-CSF immunotherapy. Stopping rules were not met for this study.|||Participants|||Count of Participants
1297891|NCT00003199|Secondary|Overall Survival|Overall survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF.|11 years||||Participants|||Count of Participants
1297892|NCT00003199|Primary|Event-free Survival|Event-free survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF.|11 years|Study-wide, 20 patients out of 50 have event-free survival.|||Participants|||Count of Participants
1297893|NCT00003138|Secondary|Quality of Life- Total Functional Assessment of Cancer Therapy - General (FACT-G) Score at 4 Months|The FACT-G scale has 4 dimensions, including physical well-being, social/family well-being, emotional well-being, and functional well-being. The score for each subscale was added together to obtain the total FACT-G score that was evaluated on this study. The total FACT-G score ranges from 0 to 108 with higher scores reflecting better quality of life. It was administered at the time of study entry, every 4 months for the first year, and at the time patient went off treatment. Due to limited data after 4 months on treatment, the analysis was restricted to the four-month time point.|Assessed at 4 months|Only patients who completed quality of life assessment at 4 months were included in this analysis.|||Scores on a scale||Standard Deviation|Mean
1297894|NCT00003138|Secondary|Overall Survival|Time from randomization to death from any cause. Patients alive at the time of analysis were censored at the date of last contact.|Assessed every 3 months for 2 years, every 6 months for 3 subsequent years, and annually thereafter|All patients with complete data were included in this analysis.|||Months||95% Confidence Interval|Median
1297895|NCT00003138|Primary|Proportion of Patients Free of Transfusion at 4 Months|Whether a patient required transfusion or not at 4 months was recorded.|Assessed at 4 months|Only patients with transfusion data were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1297896|NCT00002975|Primary|Response Rate||One Year|PI died, leaving incomplete data. Data not analyzed.||||||
1297897|NCT00002931|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.||||Months||95% Confidence Interval|Median
1297898|NCT00002931|Primary|Toxic Effects|Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy|From date of randomization until death of any cause, assessed up to 12 weeks||||participants|||Number
1297899|NCT00002931|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.|Until disease progression, up to 5 years.||||Months||95% Confidence Interval|Mean
1297900|NCT00002874|Secondary|Grade 3+ Toxicity|"Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as Acute Radiotherapy, all later toxicities are reported as Hormone therapy and late radiotherapy toxicity. The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death."|From date of randomization to four years.|Eligible patients who started protocol treatment and did not withdraw consent.|||participants|||Number
1297901|NCT00002874|Secondary|Progression-free Survival (12-year Rates Reported)|"Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. Progression-free Survival is more accurate wording for the protocol endpoint of Freedom from Progression, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1297902|NCT00002874|Secondary|Prostate Cancer Death (12-year Rates Reported)|"Prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. Prostate cancer death is a more accurate wording for the protocol endpoint of disease-specific survival, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1297903|NCT00002874|Secondary|Distant Failure (12-year Rates Reported)|Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1297904|NCT00002874|Secondary|PSA Complete Response at End of Protocol Treatment|Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA < 05 ng/ml.|End of protocol treatment, which is planned to last for two years|Eligible patients who did not withdraw consent.|||Participants|||Count of Participants
1297905|NCT00002874|Secondary|Third PSA Recurrence (12-year Rates Reported)|Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From start of salvage hormone therapy to 12 years.|Eligible patients who did not withdraw consent and who started salvage hormone therapy.|||percentage of participants||95% Confidence Interval|Number
1297906|NCT00002874|Secondary|Second PSA Recurrence (12-year Rates Reported)|Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to >= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of >= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of >= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1297907|NCT00002874|Secondary|Non-Prostate Cancer Death (12-year Rates Reported)|"Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported.~Patients are followed until death. Non-Prostate cancer death is a more accurate wording for the protocol endpoint of non-disease-specific survival, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1297908|NCT00002874|Primary|Overall Survival (12-year Rates Reported)|"Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported.~Patients are followed until death."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
1297909|NCT00002850|Primary|Proportion of Patients Experiencing a Serious Bacterial Infection|This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.|First three months of chemotherapy||||percentage of participants||95% Confidence Interval|Number
1297910|NCT00002842|Primary|2 Year Disease-free Survival .|Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.|2 years after treatment||||percentage of participants||95% Confidence Interval|Number
1298395|NCT00045942|Secondary|Summary of Midostaurin Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, was considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
1297911|NCT00002766|Primary|Complete Remission (CR)|complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia.|2 years||||participants|||Number
1297912|NCT00002651|Other Pre-specified|General Symptoms||15 months|||||||
1297913|NCT00002651|Other Pre-specified|Role Functioning|Mean of the change in role functioning from randomization|15 months|||||||
1297914|NCT00002651|Other Pre-specified|Social Functioning|Mean of the change in social functioning from randomization|15 months|||||||
1297915|NCT00002651|Other Pre-specified|Global Perception of Quality of Life||15 months|||||||
1297916|NCT00002651|Primary|Vitality|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. This analysis looks at mean change from Baseline score to 3 Months.|3 months|Only eligible patients with a usable form set for Vitality both at baseline and 3 months were included in this analysis.|||units on a scale||Standard Error|Mean
1297917|NCT00002651|Primary|High Libido|"This outcome was assessed by having patients report whether their interest in sexual activities was very high, high, or moderate (a score of 1) or low or very low (a score of 0). This outcome measure is reporting a change from baseline in the percentage of participants with High Libido at 3 months. High Libido is defined as very high, high or moderate interest in sexual activities."|3 months|Only eligible patients with a usable answers regarding libido both at baseline and 3 months were included in this analysis.|||percentage of participants|||Number
1297918|NCT00002651|Primary|Erectile Dysfunction|This outcome was assessed by having patients report whether they had erectile dysfunction (a score of 1) or no erectile dysfunction (a score of 0). This analysis looks at change from Baseline to 3 Months.|3 months|Only eligible patients with a usable answers regarding erectile dysfunction both at baseline and 3 months were included in this analysis.|||percentage of participants|||Number
1297919|NCT00002651|Primary|Emotional Functioning as Measured by the SF-36 Mental Health Inventory|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months|3 months|Only eligible patients with a usable form set for SF-36 Mental Health Inventory both at baseline and 3 months were included in this analysis.|||units on a scale||Standard Error|Mean
1297920|NCT00002651|Primary|Physical Functioning as Measured by the SF-36|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months|3 months|Only eligible patients with a usable form set for Physical Functioning portion of the SF-36 both at baseline and 3 months were included in this analysis.|||units on a scale||Standard Error|Mean
1297921|NCT00002651|Primary|Overall Survival|Non-inferiority test to determine if intermittent combined androgen deprivation (CAD) overall survival is not substantially worse than continuous CAD overall survival. Specifically, the trial is designed for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. The assumptions used to compute the trial size are an overall type I error rate of 0.05 and a type II error of 0.10 (power = 0.9).|Up to 15 years||||years||95% Confidence Interval|Median
1297922|NCT00002558|Primary|Overall Objective Response|Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy}|2 years||||participants|||Number
1297923|NCT00052078|Primary|Clinical Global Impression - Improvement Scale|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression – Improvement scale.|Measured at Week 12||||percentage of participants||95% Confidence Interval|Number
1297924|NCT00051636|Secondary|Number of Participants With a Disease Relapse During the Extended Observation Period|Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||Participants|||Number
1297925|NCT00051636|Secondary|Number of Participants With a Partial Disease Relapse During the Extended Observation Period|Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||Participants|||Number
1297926|NCT00051636|Secondary|Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period|Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||Participants|||Number
1297927|NCT00051636|Secondary|Change in Pain Interference Score|Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.|||Units on a scale||Standard Deviation|Mean
1297928|NCT00051636|Secondary|Change in Pain Severity Score|Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.|||Units on a scale||Standard Deviation|Mean
1297929|NCT00051636|Secondary|Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline|Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.|Baseline and day 28|Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.|||Participants|||Number
1297930|NCT00051636|Secondary|Time to First Therapeutic Response|A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.|182 days|Intent-to-treat population: all randomized patients.|||Days||Inter-Quartile Range|Median
1297931|NCT00051636|Secondary|Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10|The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.|||Percent change||Standard Deviation|Mean
1297932|NCT00051636|Secondary|Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10|The percent change in serum C-telopeptide from baseline to day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.|||percent change||Standard Deviation|Mean
1297933|NCT00051636|Secondary|Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28|The percent change in serum alkaline phosphatase from baseline to day 28 was measured.|Baseline and day 28|Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.|||percent change||Standard Deviation|Mean
1297934|NCT00051636|Primary|Number of Patients Who Achieve Therapeutic Response at 6 Months.|Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.|6 months|Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.|||participants|||Number
1297935|NCT00051558|Secondary|Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures|Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.|36 months|For vertebral fractures, only those patients with baseline and postbaseline spinal radiographs were included in the analysis.|||participants|||Number
1297936|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers|||percent||Standard Error|Mean
1297937|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers|||percent||Standard Error|Mean
1297938|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers|||percent||Standard Error|Mean
1297939|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers.|||percent||Standard Error|Mean
1297940|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers|||percent||Standard Error|Mean
1297941|NCT00051558|Secondary|Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)|12, 18, 24, and 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.|||grams per square centimeters||Standard Error|Least Squares Mean
1297942|NCT00051558|Secondary|Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)|12, 18, 24, and 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.|||grams per square centimeters||Standard Error|Least Squares Mean
1297943|NCT00051558|Secondary|Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)|18, 24, 36 months, and 18 and 36 month endpoints|The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.|||grams per square centimeters||Standard Error|Least Squares Mean
1297944|NCT00051558|Secondary|Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)|18, 24, 36 months, and 18 and 36 month endpoints|The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied.|||grams per square centimeters||Standard Error|Least Squares Mean
1298425|NCT00044512|Secondary|Time to Progression|Time from the first date of receiving study drug until the first documented PD.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
1297945|NCT00051558|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|24 and 36 months and Endpoint at 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied.|||grams per square centimeters||Standard Error|Least Squares Mean
1297946|NCT00051558|Secondary|Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|3, 6, 12, and 18 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.|||grams per square centimeters||Standard Error|Least Squares Mean
1297947|NCT00051558|Secondary|Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|3, 6, 12, 18, 24, 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.|||grams per square centimeters||Standard Error|Least Squares Mean
1297948|NCT00051558|Secondary|Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset|change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|18 month endpoint|The intention-to-treat analysis was performed using all randomized and treated patients (female only subset).|||grams per square centimeters||Standard Error|Least Squares Mean
1297949|NCT00051558|Primary|Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)|change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|18 month endpoint|The intention-to-treat analysis was performed using all randomized and treated patients.|||grams per square centimeters||Standard Error|Least Squares Mean
1297950|NCT00051363|Other Pre-specified|Functional Magnetic Resonance Imaging (fMRI)||Measured at diagnostic visit (baseline) and 6 months post intervention|fMRI was dropped as a secondary outcome measure for analysis by our Core Team.||||||
1297951|NCT00051363|Secondary|Quality of Life: Calgary Sleep Apnea Quality of Life Index- Total Score (SAQLI-TS)|Quality of life was measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI), which is an interview-administered instrument with high internal consistency and reliability. The SAQLI was designed to assess components identified as important to patients including daily functioning, social interactions, emotional functioning, symptoms experienced, and treatment-related symptoms. Items are scored on a seven-point scale, averaged (taking into account treatment-related symptoms), to yield a composite score between 1 and 7, where higher scores represent better quality of life.|diagnostic visit (baseline)|Analyses performed for group of participants with SAQLI data. Baseline demographics were generally similar (mean age, sex ratio, proportion of white participants, average body mass index), and participants in both groups had similar SAQLI scores at baseline, which are presented below.|||Units on a scale||Standard Deviation|Mean
1297952|NCT00051363|Secondary|Mood||Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Mood was dropped as a secondary outcome measure for analysis by our Core Team.||||||
1297953|NCT00051363|Secondary|Subjective Sleepiness/Alertness: Epworth Sleepiness Scale- Total Score (ESS-TS)|"Subjective sleepiness/alertness was measured using the Epworth Sleepiness Scale (ESS); the outcome variable was ESS Total Score (ESS-TS).~The ESS is a validated questionnaire (8 questions) that ask the chances of dozing off in specific situations. Summing the scores produces a scaled total score between 0 and 24, with higher numbers indicating more subjective sleepiness. The ESS was administered the evening before the polysomnogram (PSG), or overnight sleep study. Data reported here include questionnaires collected at the DX, 2M, and 6M visits."|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||scores on a scale||Standard Deviation|Mean
1297954|NCT00051363|Secondary|Objective Sleepiness/Alertness: Maintenance of Wakefulness Test- Mean Sleep Latency (MWT-MSL)|"Objective sleepiness/alertness was measured using the Maintenance of Wakefulness Test (MWT); the outcome variable was MWT Mean Sleep Latency (MWT-MSL).~The MWT was administered using four twenty-minute trials where the participant was asked to sit in a chair, in a quiet and dimly lit room, with instructions to stay awake. Trials were performed at 10 AM, Noon, 2 PM and 4 PM. The mean sleep latency was calculated using the 4 trials from a given visit, and required that at least 3 of the 4 trials were performed and validated."|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||minutes||Standard Deviation|Mean
1297955|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD), SWMT- Mid-day Activation Index (SWMT-ActMD), and Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh).~These data are for variable #3: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||number of rule changes (dichotomized)||95% Confidence Interval|Mean
1298817|NCT00023595|Secondary|H02: All-cause (Unplanned and Elective) Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1297956|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: SWMT- Mid-day Activation Index (SWMT-ActMD)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh.~These data are for variable #2: SWMT- Mid-day Activation Index (SWMT-ActMD)~SWMT-ActMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline (BL) using standard deviation units. It is computed as the difference from BL relative to EEG power spectral variables (decibels) measured during the easier vs. more difficult working memory (WM) tasks. A positive activation sub-score indicates a larger cortical neuronal population was recruited to perform the more difficult WM task relative to BL, while a negative score indicates a smaller population was recruited."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||score on a scale||95% Confidence Interval|Mean
1297957|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh.~These data are for variable #1: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)~SWMT-BehMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the difference from baseline relative to measures of working memory (WM) task performance accuracy (percent correct) and mean and standard deviation of reaction time (milliseconds). High-load WM tasks receive twice the weight of the low-load WM tasks."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||score on a scale||95% Confidence Interval|Mean
1297958|NCT00051363|Secondary|Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec)|The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. One of the selected variables came from the domain of Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec).|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||number of words recalled||95% Confidence Interval|Mean
1297959|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #3: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||milliseconds||95% Confidence Interval|Mean
1297960|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #2: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||milliseconds||95% Confidence Interval|Mean
1297961|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #1: Pathfinder Number- Reaction Time (PN-RT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||seconds||95% Confidence Interval|Mean
1298692|NCT00032591|Secondary|Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)|Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio|Full length of follow-up; average of 3 years|Randomized participants with at least one day of follow-up, per intent to treat|||percentage||Standard Deviation|Mean
1297962|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: L/M Function- BSRT-SR|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #3: Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR)"|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.|||number of words recalled||95% Confidence Interval|Mean
1297963|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: A/P Function- PFN-TOTL|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #2: Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL)"|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.|||seconds||95% Confidence Interval|Mean
1297964|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: E/F Function- SWMT-OMD|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #1: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD)~SWMT-OMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the mean of three sub-scores, one based on working memory (WM) task performance (behavioral WM sub-score: speed, accuracy), and the other two on electroencephalogram (EEG) (cortical activation sub-score: neural workload, attentional effort during WM task; alertness sub-score: resting alertness)."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.|||score on a scale||95% Confidence Interval|Mean
1297965|NCT00051168|Primary|Mean Intraocular Pressure|"Mean IOP for the patient’s worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken.~All IOP measurements were performed with a Goldmann applanation tonometer."|At 5 years.||||millimeters mercury (mm Hg)||Standard Deviation|Mean
1297966|NCT00051025|Secondary|Time-to-Treatment Failure||From start of first treatment|||||||
1297967|NCT00051025|Secondary|Duration of Response|The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression.|From beginning of response to time of relapse|Intent-to-treat. Please note: Data represent 1 subject in each treatment group who responded.|||Days|||Number
1297968|NCT00051025|Primary|Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.|Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy|24 Weeks|Intent-to-treat|||Participants|||Number
1297969|NCT00050986|Secondary|Progression-free Survival (Phase II)|Efficacy measured by 6 month progression-free survival assessment.|6 months|||||||
1297970|NCT00050986|Primary|Maximal Tolerating Dose (MTD for Phase I)|"Phase I Dose limiting toxicity evaluation at end of first cycle based on blood tests every two weeks and participants' subjective and objective symptoms.~Start Dose Level 100 mg/m² Temozolomide once daily + 400 mg ZARNESTRA twice daily; Dose Level 1 100 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 2 150 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 3 150 mg/m² Temozolomide once daily + 600 mg ZARNESTRA twice daily; Dose Level 4 150 mg/m² Temozolomide once daily + 800 mg ZARNESTRA twice daily"|End of first cycle (4 weeks) evaluation|As treated.|||participants|||Number
1297971|NCT00050960|Primary|Overall Survival||From date of randomization to date of death|Intent-to-Treat (ITT)|||Months||Full Range|Median
1297972|NCT00050778|Secondary|Percent Change From Baseline in MRI T2 Lesion Volume at Year 3|Percent change in lesion volume at Year 3 was calculated from MRI-T2-weighted scans as: 100*([lesion volume at Year 3] minus [lesion volume at Baseline]) divided by [lesion volume at Baseline]).|Baseline, Year 3|Analysis population included participants in the FAS population (randomized with a correct diagnosis of MS) who had an evaluable scan for MRI-T2 lesion volume at Baseline and Year 3.|||percent change||Standard Deviation|Mean
1297973|NCT00050778|Secondary|Percent Change From Baseline in T1 Cerebral Volume at Year 3|Magnetic resonance imaging (MRI) T1 was used to determine rate of cerebral atrophy (decrease in cerebral/brain volume). Partial brain volumes were measured using the technique of Losseff et al. (1996). Percent change in cerebral volume at Year 3 was calculated from MRI-T1-weighted scans as: 100*([brain volume at Year 3] minus [brain volume at Baseline]) divided by [brain volume at Baseline]).|Baseline, Year 3|Analysis population included participants in the FAS population (randomized with a correct diagnosis of MS) who had an evaluable scan for MRI-T1 brain volume at Baseline and Year 3.|||percent change||Standard Deviation|Mean
1297974|NCT00050778|Secondary|Probability of Participants Who Were Relapse Free at 3 Years After Initial Treatment|Participants were considered relapse free at Year 3 if they did not experience a relapse between randomization and study completion at 36 months. Participants who discontinued early were considered relapse free if they did not experience a relapse prior to discontinuation. Probability of participants who were relapse free at Year 3, estimated using the KM method, was reported.|Year 3|FAS population included all randomized participants who had correct diagnosis of MS at entry.|||probability of participants||95% Confidence Interval|Number
1297975|NCT00050778|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated using a Poisson regression model with observed number of relapses as a dependent variable, the log total amount of follow-up from date of randomization for each participant as an offset variable and treatment group indicator as a covariate.|Up to 3 years|FAS population included all randomized participants who had correct diagnosis of MS at entry.|||relapses per participant per year||95% Confidence Interval|Number
1297976|NCT00050778|Primary|Probability of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with Baseline score of 1.0 or more; and the increase persisted for at least next the 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Probability of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 3 years|Full Analysis Set (FAS) population included all randomized participants who had correct diagnosis of MS at entry.|||probability of participants with SAD||95% Confidence Interval|Number
1297977|NCT00050622|Secondary|Treatment Satisfaction|Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).|End of Treatment||||Units on scale||Standard Deviation|Mean
1297978|NCT00050622|Primary|Classroom Behavior|Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.|Daily for 45 days||||Percentage of Work Completed||Standard Deviation|Mean
1297979|NCT00050622|Primary|Social Behavior-Negative Verbalizations|Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.|Daily for 45 days||||Number of Observed Behaviors||Standard Deviation|Mean
1297980|NCT00050167|Secondary|Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes|Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.|7 years|||||||
1297981|NCT00050167|Secondary|Proportion of Participants With Pathological Complete Response|Safety of 2 Different Treatments determined by proportion of participants who achieved pathological complete response (pCR) between two different treatments; where pCR was defined as no histopathologic evidence of any residual invasive cancer cells in the breast and axillary lymph nodes.|7 Years|||||||
1297982|NCT00050167|Primary|Percentage of Participants With Reoccurrence|Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).|Median of 50 months|"(WP Arm):301 included in the intent to treat analysis and 297 included in the safety analysis.~(DX Arm):300 included in the intent to treat analysis and 292 included in the safety analysis."|||participants||95% Confidence Interval|Log Mean
1297983|NCT00050089|Secondary|Number of Participants With New, Non-HIV Related Serious Adverse Event|New, on-study non-HIV related Serious Adverse events were compared between ARDFP (interruption) and No ARDFP (continuation)|From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years||||participants|||Number
1297984|NCT00050089|Secondary|Number of Participants With a New, Non-HIV Related Serious Adverse Event|New, on-study non-HIV related Serious Adverse events were compared between Standard-ART (standard) and Mega-ART (intensification)|From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years||||participants|||Number
1297985|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between No ARDFP (continuation)+Standard-ART (standard), No ARDFP (continuation)+Mega-ART (intensification), ARDFP (interruption)+Standard-ART (standard) and ARDFP (interruption)+Mega-ART (intensification)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to one of the four interventions (339 via the 2X2 factorial design)|||participants|||Number
1297986|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between No ARDFP (continuation) and ARDFP (interruption)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to No ARDFP or ARDFP (339 via the 2X2 factorial design and 0 via the UK Option Scheme)|||participants|||Number
1297987|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to Standard-ART or Mega-ART (339 via the 2X2 factorial design and 29 via the UK Option Scheme)|||participants|||Number
1297988|NCT00050011|Secondary|Rate of Change From Baseline in Total Hip BMD|The rate of change from baseline in BMD was assessed.|Baseline, 5 years|ITT population|||g/sq. cm/month||95% Confidence Interval|Mean
1297989|NCT00050011|Secondary|Rate of Change From Baseline in Lumbar Spine (L1-L4) BMD|The rate of change from baseline in BMD was assessed.|Baseline, 5 years|ITT population|||g/sq cm/month||95% Confidence Interval|Mean
1298807|NCT00023595|Secondary|H01: LVEF by CMR Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.|From randomization to 24 months follow-up|Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
1297990|NCT00050011|Secondary|Time to Disease Recurrence/Relapse|The median time to disease progression was assessed by Kaplan-Meier analysis. The Principal Investigator assessed each participant for disease recurrence at each visit. Further testing was performed at the discretion of the Principal Investigator and as clinically indicated. Disease progression was defined as chest wall and/or regional recurrence confirmed by positive cytology or biopsy, and/or distance recurrence of the 1) skin, subcutaneous tissue, and lymph nodes (other than local or regional), 2) bone marrow, 3) lung, 4) skeleton 5) liver and 6) central nervous system confirmed by positive cytology, biopsy, aspirate or radiology as appropriate.|over 5 years|ITT population|||months||95% Confidence Interval|Median
1297991|NCT00050011|Secondary|Incidence Rate of All Clinical Fractures|The number of participants who experienced a clinical fracture at month 36 was assessed. Initial x-ray (both AP and lateral views) of the lumbar and thoracic spine were performed at baseline to exclude participants with evidence of fracture. In addition, repeated bone scan and/or x-ray were performed at the Principal Investigator's discretion during the course of the study to confirm evidence of clinical fracture, or at month 36 if there was no evidence of clinical fracture (lumbar and thoracic spine - lateral view). X-ray films were sent to a central reader.|3 years|ITT population|||Participants|||Number
1297992|NCT00050011|Secondary|Percent Change From Baseline in Biochemical Markers of Bone Turnover, Serum N-Telopeptide (sNTX) and Bone-specific Alkaline Phosphatase (BSAP)|Blood samples from a subset of participants (231 participants in total) were collected to measure the sNTX and BSAP. Missing data at month 12 were imputed by using the LOCF method. Post-baseline non-missing data from months 6 and 9 were carried forward to month 12. Data prior to month 6 were not carried forward. Missing data beyond month 12 were not imputed by LOCF.|Baseline, 12 months, 2 years, 3 years, 5 years|ITT population|||Percentage of biochemical markers||Standard Deviation|Mean
1297993|NCT00050011|Secondary|Percent Change From Baseline in Total Hip BMD|"Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader.~Percent change = 100*((BMD at Time Frame - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the LOCF method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward."|Baseline, 12 months, 2 years, 3 years, 5 years|ITT population|||Percentage of BMD||Standard Deviation|Mean
1297994|NCT00050011|Secondary|Percent Change From Baseline in Lumbar Spine (L1-L4) BMD|"Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader.~Percent change = 100*((BMD at Time Frame - Baseline BMD)/Baseline BMD)). Missing data beyond month 12 were not imputed by LOCF."|Baseline, 2 years, 3 years, 5 years|ITT population|||Percentage of BMD||Standard Deviation|Mean
1297995|NCT00050011|Primary|Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)|Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.|Baseline, 12 months|Intent to treat (ITT population) was used. The ITT population contained all patients in the safety population for whom at least one post-baseline efficacy measurement was collected.|||Percentage of BMD||Standard Deviation|Mean
1297996|NCT00049842|Secondary|Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.|"Definitions:~Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).~Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.|||Participants|||Number
1297997|NCT00049842|Secondary|Mean Change in the METAVIR Activity Score (Using a Continuous Scale)|"The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.~Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis)."|Baseline to up to Month-36|ITT population who had both pre and up to Month-36 METAVIR activity score.|||Units on a scale||Standard Deviation|Mean
1297998|NCT00049842|Secondary|The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline|"Definitions:~Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).~Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.|||Participants|||Number
1297999|NCT00049842|Secondary|Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)|"The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.~Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis)."|Baseline to up to Month-36|ITT population who had both pre and up to Month-36 METAVIR fibrosis score.|||Units on a scale||Standard Deviation|Mean
1298808|NCT00023595|Secondary|H02: LVEF by RN Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.|From randomization to 24 months follow-up|Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
1298000|NCT00049842|Secondary|Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)|"Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).~Changes in liver inflammation defined as follows:~Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.|||Participants|||Number
1298001|NCT00049842|Primary|Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).|"Definitions:~Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).~Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is Intent-to-Treat (ITT). Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.|||Participants|||Number
1298002|NCT00048932|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337|All DB participants treated on study who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 68 participants were not evaluated for anti-abatacept anti-bodies on study.|||participants|||Number
1298003|NCT00048932|Primary|OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities|Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Days 365 to Day 1821|All Treated Population.|||participants|||Number
1298004|NCT00048932|Primary|OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. N=Number of Participants Analyzed, n=number of participants with measurements at time point|||participants|||Number
1298005|NCT00048932|Primary|OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant was not evaluated for electrolyte abnormalities.|||participants|||Number
1298006|NCT00048932|Primary|OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant was not evaluated for liver function abnormalities.|||participants|||Number
1298007|NCT00048932|Primary|OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population.|||participants|||Number
1298008|NCT00048932|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day 365 to Day 1821|All Treated Participants, all participants who received at least 1 dose of study medication|||participants|||Number
1298009|NCT00048932|Primary|Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug|Day 365 to Day 1,821|All Treated Participants|||participants|||Number
1298010|NCT00048932|Primary|DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities|Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337. Vital signs were measured at these visits before and after study medication infusion.|All Treated Population.|||participants|||Number
1298011|NCT00048932|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1, 29, 57, 85, 113,169, 281, 365|All participants treated during DB who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 561 participants were not evaluated for anti-abatacept anti-bodies during the DB.|||participants|||Number
1298012|NCT00048932|Primary|DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria|ULN=upper level of normal; BL=baseline.Marked abnormality criteria: High alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; high aspartate aminotransferase (AST): >3* ULN (80 U/L), or if BL>ULN then use >4* BL; high alanine aminotransferase (ALT): >3* ULN (34-47 U/L), or if BL>ULN then use >4* BL; high G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; high bilirubin: >2* ULN, or if BL>ULN then use >4* BL; high blood urea nitrogen (BUN): >2* BL; high creatinine: >1.5* BL (ULN 14.6 pg/mg. AST ULN=80 U/L; ALT ULN=34-47 U/L;creatinine ULN=14.6 pg/mg.|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Population. Two participants in the ABA group and 3 participants in the PLA group were not evaluated for blood chemistry abnormalities due to data unavailability (missing data).|||participants|||Number
1298013|NCT00048932|Primary|DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant in each group was not evaluated for hematology abnormalities due to data unavailability (missing data).|||participants|||Number
1298014|NCT00048932|Primary|DB; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Participants, all participants who received at least 1 dose of study medication|||participants|||Number
1298015|NCT00048932|Primary|Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Participants, all participants who received at least 1 dose of study medication|||participants|||Number
1298016|NCT00048815|Primary|Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment|We expect that subjects treated for Minor Depression for 12 weeks with either St. John’s Wort or citalopram will have similar safety profiles to subjects treated with placebo, and will not differ by more than 20% in rates of adverse side effects (e.g., nausea, headache, insomnia, hypersomnia, diarrhea) from subjects treated with placebo. This was measured by the number of adverse events (physical symptoms) emerging or worsening during 12 weeks of treatment.|Change from Baseline to Week 12||||Number of events||Standard Deviation|Mean
1298017|NCT00048815|Primary|Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)|We expect that subjects with minor depression treated for 12 weeks with St. John's Wort or citalopram will have significantly greater reduction in depressive symptom severity than those treated with placebo. This will be measured by blind ratings on the Inventory of Depressive Symptomatology – Clinician Rated (IDS-C) which has a total score range from 0 to 84 with 0 being not depressed at all and 84 being the most depressed. The change will be calculated by subtracting the Week 12 score from the Baseline score.|Change from Baseline to Week 12||||units on a scale||Standard Error|Least Squares Mean
1298018|NCT00048581|Secondary|Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|From BL (Day 1) to Day 1821|All participants treated on study with at least one post-baseline immunogenicity measurement.|||participants|||Number
1298019|NCT00048581|Secondary|OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL|Limitations on activities of daily living in the OL period at each study visit was measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.|Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298020|NCT00048581|Secondary|OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL|Limitations on activities of daily living in the OL period at each study visit were measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298021|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL|Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.|||units on a scale||Standard Error|Mean
1298022|NCT00048581|Secondary|OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL|Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298023|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL|The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.|||units on a scale||Standard Error|Mean
1298024|NCT00048581|Secondary|OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL|The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. The mean score of the SPI in a population with chronic problems is 29.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298025|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298818|NCT00023595|Secondary|H01: All-cause (Unplanned and Elective) Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298026|NCT00048581|Secondary|OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298027|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298028|NCT00048581|Secondary|OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298029|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298030|NCT00048581|Secondary|OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298031|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298069|NCT00048581|Secondary|DB; Number of Participants AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From BL up to database lock for DB period (6/2/2004)|All treated participants|||participants|||Number
1298032|NCT00048581|Secondary|OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298033|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298034|NCT00048581|Secondary|OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298035|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298036|NCT00048581|Secondary|OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298037|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298070|NCT00048581|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From BL up to database lock for DB period (6/2/2004)|All treated participants|||participants|||Number
1298038|NCT00048581|Secondary|OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298039|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298040|NCT00048581|Secondary|OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298041|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298042|NCT00048581|Secondary|OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298043|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL|IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||pg/ml||Standard Error|Mean
1298044|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL|IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Time-matched baseline levels of IL-2R were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||pg/ml||Standard Deviation|Mean
1298809|NCT00023595|Secondary|H01: LVEF by RN Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.|From randomization to 24 months follow-up|Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
1298045|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL|ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mm/hr||Standard Error|Mean
1298046|NCT00048581|Secondary|OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL|ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Time-matched baseline levels of ESR were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mm/hr||Standard Deviation|Mean
1298047|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL|CRP is an acute phase reactant protein that is a clinical marker for RA. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mg/dL||Standard Error|Mean
1298048|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Time-matched baseline levels of CRP were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mg/dL||Standard Deviation|Mean
1298049|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL|RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||IU/ml||Standard Error|Mean
1298050|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL|RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Time-matched baseline levels of RF were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||IU/ml||Standard Deviation|Mean
1298051|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL|HAQ-DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit|BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298052|NCT00048581|Secondary|OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL|The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298053|NCT00048581|Secondary|OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL|The HAQ disability index (HAQ DI) is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants analyzed, n=number of participants with measurements at visit.|||participants|||Number
1298054|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL|DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298055|NCT00048581|Secondary|OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298056|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL|DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
1298057|NCT00048581|Secondary|OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298058|NCT00048581|Secondary|OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||participants|||Number
1298071|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Error|Mean
1298059|NCT00048581|Secondary|OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL|ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||participants|||Number
1298060|NCT00048581|Primary|OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL|Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with serum samples available at that visit.|BL, Days 169, 365, 729, and 1093|All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.|||mg/dL||Standard Error|Mean
1298061|NCT00048581|Primary|OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL|Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with serum samples available at that visit.|Baseline and Days 169, 365, 729, and 1093|All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.|||mg/dL||Standard Deviation|Mean
1298062|NCT00048581|Primary|OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From first day of OL to 5.5 years|All treated participants|||participants|||Number
1298063|NCT00048581|Primary|OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|From first day of OL to 5.5 years|All treated participants|||participants|||Number
1298064|NCT00048581|Primary|OL; Number of Participants AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From first day of OL to 5.5 years|All treated participants|||participants|||Number
1298065|NCT00048581|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|From BL to Day 169|All treated participants in the double-blind period with at least 1 post-baseline immunogenicity result|||participants|||Number
1298066|NCT00048581|Primary|Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From first day of OL to 5.5 years|All treated participants|||participants|||Number
1298067|NCT00048581|Secondary|DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From BL up to database lock for DB period (6/2/2004)|All treated participants|||participants|||Number
1298068|NCT00048581|Secondary|DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|From BL up to database lock for DB period (6/2/2004)|All treated participants|||participants|||Number
1298072|NCT00048581|Secondary|DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline. The mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with assessments available at that visit.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Deviation|Mean
1298073|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169|HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||units on a scale||Standard Deviation|Mean
1298074|NCT00048581|Secondary|DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169|The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||units on a scale||Standard Deviation|Mean
1298075|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value – time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Deviation|Mean
1298076|NCT00048581|Secondary|DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169|SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with data available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Deviation|Mean
1298077|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value – time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 85.|BL, Day 85|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Error|Mean
1298093|NCT00048581|Secondary|DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component|The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298078|NCT00048581|Secondary|DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85|SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 85 BL value for only that cohort of participants with data available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Deviation|Mean
1298079|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status|Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤ 20 IU/mL.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||participants|||Number
1298080|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169|Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. Change from Baseline = Post-baseline value – time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||ng/ml||Standard Error|Mean
1298081|NCT00048581|Secondary|DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169|Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||ng/ml||Standard Deviation|Mean
1298082|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169|The mean change from baseline in levels of potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. Change from Baseline = Post-baseline value – time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||pg/ml||Standard Error|Mean
1298083|NCT00048581|Secondary|DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169|Potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||pg/ml||Standard Deviation|Mean
1298084|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
1298085|NCT00048581|Secondary|DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels of CRP indicate increasing level of disease. For each post-baseline visit in the DB, time-matched baseline CRP values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mg/dL||Standard Deviation|Mean
1298086|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component|Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
1298087|NCT00048581|Secondary|DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component|Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Physician Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298088|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
1298089|NCT00048581|Secondary|DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298090|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component|A self-administered questionnaire with 20 questions assessing physical function in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Questions evaluated on a 4-point scale:0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=weighted sum of scale scores, with higher scores indicating poorer function. Mean time-matched % change from BL=(time-matched BL value - Post-BL value)/time-matched BL value x100, where time-matched BL value=the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
1298091|NCT00048581|Secondary|DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component|HAQ-DI is a self-administered questionnaire composed of 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ-DI is the weighted sum of the scale scores, with higher scores indicating poorer function. For each post-BL visit, time-matched BL HAQ-DI values were presented and represent the mean BL value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1298092|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component|Participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
1298094|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component|The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicate increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
1298095|NCT00048581|Secondary|DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component|The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicates increasing level of severity. Time-matched baseline SJC values for each post-baseline SJC in the DB were presented for each visit and represent the mean baseline SJC value for only that cohort of participants with SJCs available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.|||swollen joints||Standard Deviation|Mean
1298096|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component|The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
1298097|NCT00048581|Secondary|DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component|The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Time-matched baseline TJC values for each post-baseline TJC in the DB were presented for each visit and represent the mean baseline TJC value for only that cohort of participants with TJCs available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.|||tender joints||Standard Deviation|Mean
1298098|NCT00048581|Secondary|DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time|ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.|Days 15, 29, 57, 85, 113, 141, and 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||participants|||Number
1298099|NCT00048581|Primary|DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.|||participants|||Number
1298100|NCT00048581|Primary|Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized participants who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.|||participants|||Number
1298137|NCT00048568|Secondary|Mean Change From BL in RF in the DB Period|The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Error|Mean
1298101|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298102|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298103|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,989|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298104|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,989|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298105|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298106|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298107|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,625|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298108|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,625|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298109|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298110|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298111|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,345|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298112|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,345|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298113|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,261|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298114|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,261|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298115|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,177|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298116|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,177|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298117|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,093|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298118|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,093|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298119|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 981|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis.|||Units on a Scale||Standard Error|Mean
1298120|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 981|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298121|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 897|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298122|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 897|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298123|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 813|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298124|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 813|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298125|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 729|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298126|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 729|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298127|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 617|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298128|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 617|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298129|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 533|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298130|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 533|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298131|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 449|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298132|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 449|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298133|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 365|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298134|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 365|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298135|NCT00048568|Secondary|Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period|The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||ng / mL||Standard Error|Mean
1298136|NCT00048568|Secondary|Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||ng / mL||Standard Error|Mean
1298138|NCT00048568|Secondary|Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period|The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||pg / mL||Standard Error|Mean
1298139|NCT00048568|Secondary|Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||pg / mL||Standard Deviation|Mean
1298140|NCT00048568|Primary|Mean Change From BL in Serum Electrolytes in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mEq/L||Standard Error|Mean
1298141|NCT00048568|Primary|Mean BL Serum Electrolytes in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mEq/L||Standard Deviation|Mean
1298142|NCT00048568|Primary|Mean Change From BL in Select Laboratory Parameters in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
1298143|NCT00048568|Primary|Mean BL Select Laboratory Parameters in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
1298144|NCT00048568|Primary|Mean Change From BL in Liver Function Parameters in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||U/L||Standard Error|Mean
1298145|NCT00048568|Primary|Mean BL Liver Function Parameters in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||U/L||Standard Deviation|Mean
1298146|NCT00048568|Primary|Mean Change From BL in White Blood Cells in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||10^3 c/uL||Standard Error|Mean
1298147|NCT00048568|Primary|Mean BL White Blood Cells in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||10^3 c/uL||Standard Deviation|Mean
1298148|NCT00048568|Secondary|Mean Change From BL in Limitations on Activities of Daily Living in the OL Period|The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.|BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Days||Standard Error|Mean
1298149|NCT00048568|Secondary|Mean BL Limitations on Activities of Daily Living in the OL Period|Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Days||Standard Deviation|Mean
1298842|NCT00023595|Secondary|H01: All-cause Mortality or Heart-failure Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298150|NCT00048568|Secondary|Mean Change From BL in Sleep Quality in the OL Period|The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298151|NCT00048568|Secondary|Mean BL Sleep Quality in the OL Period|Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298152|NCT00048568|Secondary|Mean Change From BL in Fatigue in the OL Period|The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298153|NCT00048568|Secondary|Mean BL Fatigue in the OL Period|Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298154|NCT00048568|Secondary|Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298155|NCT00048568|Secondary|Mean BL Mental Health Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298156|NCT00048568|Secondary|Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298157|NCT00048568|Secondary|Mean BL Vitality Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298158|NCT00048568|Secondary|Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298159|NCT00048568|Secondary|Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298160|NCT00048568|Secondary|Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298161|NCT00048568|Secondary|Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298162|NCT00048568|Secondary|Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298426|NCT00044512|Secondary|Time to Response|Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
1298163|NCT00048568|Secondary|Mean BL General Health Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298164|NCT00048568|Secondary|Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298165|NCT00048568|Secondary|Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|AlAll treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298166|NCT00048568|Secondary|Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298167|NCT00048568|Secondary|Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298168|NCT00048568|Secondary|Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298452|NCT00043979|Secondary|Early Post Transplantation Relapse|Participants who experienced recurrence or progression of disease following transplant.|up to 300 days|One out of 23 participants did not have a recurrence, thus was excluded from analysis.|||Days||Full Range|Median
1298453|NCT00043979|Secondary|Median Time to Reach a Platelet Count of 50,000/mm(3)|Days for participants to achieve a platelet count of 50,000/mm(3).|up to 43 days||||Days||Full Range|Median
1298169|NCT00048568|Primary|Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||g/dL||Standard Error|Mean
1298170|NCT00048568|Primary|Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||g/dL||Standard Deviation|Mean
1298171|NCT00048568|Primary|Mean Change From BL in Participant Platelet Count in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||10^9 c/L||Standard Error|Mean
1298172|NCT00048568|Primary|Mean BL Platelet Count in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.|||10^9 c/L||Standard Deviation|Mean
1298173|NCT00048568|Primary|Mean Change From BL in Participant Hematocrit in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Percentage Blood Volume Occupied by RBCs||Standard Error|Mean
1298174|NCT00048568|Primary|Mean BL Hematocrit in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Percentage of Red Blood Cells||Standard Deviation|Mean
1298175|NCT00048568|Primary|Number of Participants Experiencing AEs of Special Interest in the OL Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
1298176|NCT00048568|Primary|Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period|Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.|Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.|All treated participants entering the OL period.|||Participants|||Number
1298177|NCT00048568|Secondary|Mean BL Physical Function Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298178|NCT00048568|Secondary|Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298195|NCT00048568|Secondary|Participant RF Seroconversion in the OL Period|This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.|Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
1298179|NCT00048568|Secondary|Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298180|NCT00048568|Secondary|Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298181|NCT00048568|Secondary|Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298182|NCT00048568|Secondary|BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period|Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298183|NCT00048568|Secondary|Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
1298184|NCT00048568|Primary|Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period|Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.|Day 1 to Day 1,821|Participants with serum samples available for evaluation of titers to abatacept.|||Participants|||Number
1298185|NCT00048568|Primary|Mean Change From BL in Immunoglobulins in the OL Period||BL (Day 0), Day 365, Day 729, Day 1,093|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).|||mg / mL||Standard Error|Mean
1298186|NCT00048568|Primary|Mean BL Immunoglobulins Over Time in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.|BL (Day 0), Day 365, Day 729, Day 1,093|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).|||mg / mL||Standard Deviation|Mean
1298454|NCT00043979|Secondary|Median Time to Reach Absolute Neutrophil Count of 500/mm(3)|Days for participants to achieve a neutrophil count of 500/mm(3).|up to 12 days||||Days||Full Range|Median
1298187|NCT00048568|Secondary|Mean Change From BL in DAS-28 ESR Over Time in the OL Period|Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Error|Mean
1298188|NCT00048568|Secondary|Mean BL DAS-28 ESR Over Time in the OL Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Deviation|Mean
1298189|NCT00048568|Secondary|Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period|Change from baseline in participant were calculated at all study visits in the DB and OL periods.|BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg / mL||Standard Error|Mean
1298190|NCT00048568|Secondary|Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period|Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg / mL||Standard Deviation|Mean
1298191|NCT00048568|Secondary|Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time|The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (> 5.1); low (≤ 3.2); remission (< 2.6).|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
1298192|NCT00048568|Secondary|Number of ACR 70 Responders in the DB and OL Periods|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
1298193|NCT00048568|Secondary|Number of ACR 50 Responders in the DB and OL Periods|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
1298194|NCT00048568|Secondary|Number of ACR 20 Responders in the DB and OL Periods|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
1298196|NCT00048568|Secondary|Mean Change From BL in ESR in the OL Period|Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Error|Mean
1298197|NCT00048568|Secondary|Mean BL ESR and CRP Levels in the OL Period|Mean baseline values are reported for each cohort at each time point.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Deviation|Mean
1298198|NCT00048568|Secondary|Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period|Marked abnormality criteria were: Aspartate Aminotransferase (AST) >3 * ULN or if BL > ULN then use >4 *BL; Alanine Aminotransferase (ALT) >3 * ULN or if BL > ULN then use > 4 * BL; Creatinine > 1.5 * BL.|Day 1 to Day 365|All treated participants in the DB period.|||Participants|||Number
1298199|NCT00048568|Secondary|Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period|Marked abnormality criteria were: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 1 to Day 365|All treated participants in the DB period.|||Participants|||Number
1298200|NCT00048568|Secondary|Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period||Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.|||Participants|||Number
1298201|NCT00048568|Secondary|Number of New Tender Joints and Number of New Swollen Joints in the DB Period|Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.|Day 169, Day 365|These data were not summarized as it was determined that no meaningful information would be obtained.|||Joints|||Number
1298202|NCT00048568|Secondary|Number of Participants With Immunogenicity to Abatacept in the DB Period|Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.|Day 1 to Day 365|Participants treated with abatacept in the DB period with at least one immunogenicity sample collected in the DB period.|||Participants|||Number
1298203|NCT00048568|Secondary|Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.|||Units on a Scale||Standard Error|Mean
1298204|NCT00048568|Secondary|Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.|||Units on a Scale||Standard Error|Mean
1298205|NCT00048568|Secondary|Mean BL Individual Components of the HAQ DI at Day 169 and Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298206|NCT00048568|Secondary|Participants Experiencing AEs of Special Interest in the DB Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.|Day 1 to Day 365|All treated participants in the DB period.|||Participants|||Number
1298455|NCT00043979|Secondary|Number of Participants With Acute and Chronic GVHD|Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100.|up to 5 years or death||||participants|||Number
1298207|NCT00048568|Secondary|Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period|All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.|Day 1 to Day 365|All randomized and treated participants.|||Participants|||Number
1298208|NCT00048568|Primary|Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period|Glucose: < 65 mg/dL or > 220 mg/dL; Fasting Glucose: <0.8 * LLN or > 1.5 * ULN or if BL < LLN then use < 0.8 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Total protein: < 0.9 * LLN or 1.1 * ULN or if BL < LLN then use 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Albumin: < 0.9 * LLN or if BL < LLN then use 0.75 * BL; Uric acid: > 1.5 * ULN or if BL > ULN then use > 2.0 * BL. All urinalysis abnormalities were defined as: if missing BL then use >= 2 or if value >=4, or if BL = 0 or 0.5 then use >= 2, or if BL = 1.0 then use >= 3, or if BL = 2.0 then use >=4.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
1298209|NCT00048568|Primary|Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period|Sodium < 0.9 * LLN or > 1.05 * ULN or if BL < LLN then use < 0.95 * BL or > ULN or if BL > ULN then use >1.05 *BL or < LLN; Potassium: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use < 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Chloride: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use <0.9 * BL or >ULN or if BL > ULN then use > 1.1 * BL or < LLN; Calcium <0.8 * LLN or > 1.2 * ULN or if BL < LLN then use <0.67 * BL or > ULN or if BL > ULN then use > 1.3 * BL or < LLN.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
1298210|NCT00048568|Primary|Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
1298211|NCT00048568|Primary|Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
1298212|NCT00048568|Primary|Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
1298213|NCT00048568|Secondary|Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.|BL (Day 0), Day 365|This analysis was not completed.|||Participants|||Number
1298214|NCT00048568|Secondary|Number of Participants Discontinuing in the DB Period|Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.|Day 1 to Day 169, Day 170 to Day 365|All randomized and treated participants in the DB period.|||Participants|||Number
1298215|NCT00048568|Secondary|ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period|CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||IU / mL||Standard Deviation|Mean
1298216|NCT00048568|Secondary|ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period|Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298235|NCT00048568|Secondary|ACR 70 Responders at Day 169|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298217|NCT00048568|Secondary|ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298218|NCT00048568|Secondary|ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298219|NCT00048568|Secondary|ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period|Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298220|NCT00048568|Secondary|ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period|The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||joints||Standard Deviation|Mean
1298221|NCT00048568|Secondary|ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period|Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Joints||Standard Deviation|Mean
1298222|NCT00048568|Secondary|Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period|The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.|BL (Day 0), Day 169, Day 365|All treated subjects in the DB period.|||mg / mL||Standard Error|Mean
1298223|NCT00048568|Secondary|Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period|The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.|BL (Day 0), Day 169, Day 365|All treated subjects in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg / mL||Standard Deviation|Mean
1298224|NCT00048568|Secondary|Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period|The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|BL (Day 0), Day 169, Day 365|Due to the closure of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg / mL||Standard Error|Mean
1298225|NCT00048568|Secondary|Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period|The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||mg / mL||Standard Deviation|Mean
1298226|NCT00048568|Secondary|Participants in the DB Period Achieving an Extended Major Clinical Response|An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 1 to Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298227|NCT00048568|Secondary|Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
1298228|NCT00048568|Secondary|Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298229|NCT00048568|Secondary|Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.|BL (Day 0), Day 365|All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Units on a Scale||Standard Deviation|Mean
1298230|NCT00048568|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 1 to Day 365|All treated subjects in the DB period.|||Participants|||Number
1298231|NCT00048568|Secondary|Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365|The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (>5.1); low (≤3.2); remission (<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365, Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
1298232|NCT00048568|Secondary|Number of Participants Achieving Major Clinical Response By Day 365|A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.|Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298233|NCT00048568|Secondary|ACR 70 Responders in the DB Period|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298234|NCT00048568|Secondary|ACR 70 Responders at Day 365|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298285|NCT00048165|Secondary|Median Change From Baseline for LDL/HDL Ratio||From Baseline (Day -2) to 3 months, and 6 months|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||ratio||Full Range|Median
1298456|NCT00043979|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|16.5 months||||Participants|||Number
1298236|NCT00048568|Secondary|ACR 50 Responders in the DB Period|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298237|NCT00048568|Secondary|ACR 50 Responders at Day 365|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298238|NCT00048568|Secondary|ACR 50 Responders at Day 169|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298239|NCT00048568|Secondary|ACR 20 Responders in the Double-Blind (DB) Period|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298240|NCT00048568|Secondary|ACR 20 Responders at Day 365|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298241|NCT00048568|Secondary|BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period|This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.|BL (Day 365)|All treated participants in the OL period (treatment groups represent treatment received in the DB period).|||Participants|||Number
1298242|NCT00048568|Secondary|Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment|Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.|BL (Day 0)|All randomized and treated participants in the DB period.|||Units on a Scale||Standard Deviation|Mean
1298243|NCT00048568|Secondary|Mean Number of Tender Joints and Swollen Joints at DB BL||BL (Day 0)|All randomized and treated participants in the DB period.|||Joints||Standard Deviation|Mean
1298244|NCT00048568|Primary|Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value|BL (Day 0), Day 365|All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the compliance issues of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Units on a Scale||Standard Deviation|Mean
1298245|NCT00048568|Primary|Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298334|NCT00048035|Secondary|Mean Change in Pulse Rate|Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug|||BpM||Standard Deviation|Mean
1298246|NCT00048568|Primary|Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
1298247|NCT00048893|Secondary|Number of Participants With a Clinical Response|Defined as measurable disease (any solid lesion that can be measured accurately in at least one dimension), evaluable disease (disease not readily measurable but can be clinically assessed), complete response (complete disappearance of all measurable and evaluable disease), partial response (decrease of greater than or equal to 50%), stable disease (any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions), or progressive disease (greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease).|At the beginning of each cycle of chemotherapy (every 4 weeks)|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Participants|||Number
1298248|NCT00048893|Secondary|Number of Participants With an Immune Response as a Result of the Salvage Immunization Schedule|Patients showing disease progression or recurrence at any point after the start of the early immunizations series may continue on study in accordance to the off study criteria and will be receiving monthly rF immunizations for a total of 12 months or until further disease progression meets the off study criteria. Immune response as evidenced by change in lymphocyte subsets in the blood.|6 weeks, than 6, 12, 18, 24, 30, 36 (3y), 42, 48 (4y), 60 and 72 months after completion of immune chemotherapy|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Participants|||Number
1298249|NCT00048893|Secondary|Number of Months of Progression Free Survival|The time period a participant remains free from progressive disease. Progressive disease (PD) is defined as a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease or the appearance of new disease or an increase in evaluable disease.|After the immune depletion cycle|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Months|||Number
1298250|NCT00048893|Secondary|Immune Response to the Vaccine in Those Patients With Late Recovery of Thymic Function|It is expected that delayed administration of a vaccine will result in enhancement of immune response to the vaccine in those patients with later recovery of thymic function as evidenced by change in lymphocyte subsets in the blood.|2 years|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Cells/L|||Number
1298251|NCT00048893|Secondary|Log Change of CD4 CEA-specific Immune Responses and Their Kinetics as a Surrogate Marker for Clinical Anti-tumor Activity of the Vaccines|Response is evaluated by CD4 response to CEA soluble protein. The log change in precursor frequencies will be calculated between values obtained at baseline and five months post immune depletion. By flow cytometry of peripheral blood lymphocyte frequency of potential killer cells directed to the CEA protein.|Baseline and 5 months post immune depletion|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||log change of CD4 CEA specific precursor|||Number
1298252|NCT00048893|Secondary|Log Change in Precursor Frequency as Measured by Elispot.|The log change in CEA-specific T cell precursor frequency will be calculated between values obtained at baseline and 5 months post immune depletion. A change equal to 1.0 standard deviation (SD) of the log change is significant.|time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||log change in CEA-specific T cell precur|||Number
1298253|NCT00048893|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|91 months||||Participants|||Number
1298254|NCT00048893|Primary|Event-free Survival as Measured by Clinical Evaluation and Tumor Measurements by Imaging|Complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is a decrease of greater than or equal to 50% in the sum of the products of the longest perpendicular dimensions of all measurable target lesions. Stable disease (SD) is any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions of measurable disease. Progressive disease (PD) is a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease.|time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Months|||Number
1298255|NCT00048737|Primary|Number of Participants With Graft Failure|Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.|100 days||||participants|||Number
1298256|NCT00048724|Secondary|Time to Observation of the Disease Progression Experienced by a Subject|Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.|Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event|Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.|||Participants|||Number
1299039|NCT00001941|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12 months|Data is not available separately per cohort.|||Participants|||Number
1298257|NCT00048724|Primary|Time to Observation of the First Clinical Event Experienced by a Subject|Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation|Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event|Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.|||Participants|||Number
1298258|NCT00048542|Other Pre-specified|Baseline Measure: Age Continuous - OLE FD Phase|Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.|Baseline OLE FD Phase||||Years||Standard Deviation|Mean
1298259|NCT00048542|Other Pre-specified|Baseline Measure: Gender, Female/Male - OLE FD Phase|Gender (female/male) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.|Baseline OLE FD Phase||||Participants|||Number
1298260|NCT00048542|Other Pre-specified|Baseline Measure: Age Continuous - OLE BSA Phase|Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.|Baseline OLE BSA Phase||||Years||Standard Deviation|Mean
1298261|NCT00048542|Other Pre-specified|Baseline Measure: Gender, Female/Male - OLE BSA Phase|Gender (female/male) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.|Baseline OLE BSA Phase||||Participants|||Number
1298262|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. Final Visit = last visit per subject (up to 224 weeks).|Final Visit (up to 224 weeks of OLE FD phase)|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.|||Participants|||Number
1298263|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 112|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.|||Participants|||Number
1298264|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 48|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.|||Participants|||Number
1298265|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Baseline|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.|||Participants|||Number
1298266|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 104|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.|||Participants|||Number
1298267|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 56|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.|||Participants|||Number
1298268|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Open-Label Lead-In Phase Baseline|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.|||Participants|||Number
1298269|NCT00048542|Secondary|Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase|Serum levels of C-reactive protein (CRP) were measured at screening (open-label baseline) and at Week 48. Negative mean changes in CRP from open-label baseline to Week 48 indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.|||mg/dL||Standard Error|Mean
1298270|NCT00048542|Secondary|Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase|A 100 mm horizontal visual analog scale (VAS) was used to assess the Parent's/Patient's Global Assessment of Disease Activity. The left end of the VAS (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.|||Units on a scale||Standard Error|Mean
1298271|NCT00048542|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase|A 100 mm horizontal visual analog scale (VAS) was used to assess the Physician Global Assessment of Disease Activity. The left end of the VAS scale (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.|||Units on a scale||Standard Error|Mean
1298272|NCT00048542|Secondary|Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 70% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.|||Participants|||Number
1298273|NCT00048542|Secondary|Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 50% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.|||Participants|||Number
1298274|NCT00048542|Secondary|Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 30% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core criteria are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.|||Participants|||Number
1298275|NCT00048542|Secondary|Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum|A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum.|||Percent participants w/o disease flare|||Number
1298276|NCT00048542|Secondary|Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum|A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum.|||Percent participants w/o disease flare|||Number
1298277|NCT00048542|Secondary|Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase|Subjects met criteria for disease flare if they had >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16 to Week 48 (32 Weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum. Missing values were treated as disease flare.|||Participants|||Number
1298278|NCT00048542|Secondary|Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase|Responders met the following criteria: >= 30% improvement in >= 3 of 6 JRA core set criteria, and >= 30% worsening in not more than 1 JRA criterion, compared with the open-label baseline. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.|||Participants|||Number
1298279|NCT00048542|Primary|Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase|The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) >= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) >= 30% improvement in not more than 1 of the 6 JRA core set criteria.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. Missing values were treated as disease flare.|||Participants|||Number
1298280|NCT00048347|Primary|Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI)|The primary endpoint is the percent of patients with a clinical response as defined by a drop in the Short Clinical Colitis Score (SCCAI) of at least 3 points from Week 0 to Week 12. Short Clinical Colitis Score (SCCAI): Bowel frequency(day0-3,night0-2),urgency(0-3),rectal bleeding(0-3),well being(0-4),extracolonic features(0-4), total score 0(best)-19(worst).|Baseline, Week 12||||Percent of participants|||Number
1298281|NCT00048165|Secondary|Number of Participants With Malignancies and Opportunistic Infections|The opportunistic infections included infections with Cytomegalovirus, Aspergillus, Candida, Pneumocystis, Cryptococcus, Listeria, Herpes simplex, Herpes zoster. For malignancy, participants with any type of malignancy whose date of onset or diagnosis was after randomization was reported.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc).|||participants|||Number
1298282|NCT00048165|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc).|||participants|||Number
1298283|NCT00048165|Secondary|Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters|A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Biochemistry included blood urea nitrogen, creatinine, serum glutamic oxalacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transferase (GGT), phosphorous, total bilirubin, direct bilirubin, total protein, albumin, glucose, alkaline phosphatase, low density lipoprotein (LDH), uric acid, carbon dioxide, magnesium, sodium, potassium, chloride, calcium, LDL, HDL, total cholesterol, and triglycerides.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by ‘n’.|||participants|||Number
1298284|NCT00048165|Secondary|Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters|A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Hematology included hemoglobin, hematocrit, white blood cell count (WBC) with differential (including granulocytes or neutrophils, basophils, eosinophils, monocytes, lymphocytes), platelets, and erythrocyte count|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by ‘n’.|||participants|||Number
1298286|NCT00048165|Secondary|Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides)|Lipid profile included total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (all total cholesterol, LDL, HDL, and triglycerides with unit milligram per decilitre [mg/dL]), were reported. The median change from baseline (Day -2) in lipid profile values at 3 months and 6 months was reported.|From Baseline (Day -2) to 3 months and 6 months|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified parameters are denoted by 'n'.|||mg/dL||Full Range|Median
1298287|NCT00048165|Secondary|Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT|The maintenance doses of mycophenolate mofetil (1.5g twice a day daily), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg oral [PO]/nasogastric [NG] within 72 hours post-operative]), and cumulative dose of corticosteroids (500-1000 mg IV methylprednisolone pre-operative switched to oral at 0.5-1 mg/kg/day. Tapered to 0.2 mg/kg/d by Day 28, 0.1-0.15 mg/kg/day from Days 36 to 90, and 0.1-0.15 mg/kg/day from Days 120 to 180)at 6 and 12 months PT were reported. Maintenance dose was calculated as total dose per day summed over all days that a participant was administered drug within the specified time interval, divided by number of days that a participant took drug within that time interval.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'.|||mg||Standard Deviation|Mean
1298288|NCT00048165|Secondary|Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT|The number of participants who received monomurab Cluster of differentiation 3, orthoclone, polyclonal antithymocyte globulin or antilymphocyte globulin for treatment of biopsy proven rejection or HDC within 6 and 12 months PT were reported.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
1298289|NCT00048165|Secondary|Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT|The median time to first acute rejection episode within first 6 months and 12 months PT was reported.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'.|||days||Full Range|Median
1298290|NCT00048165|Secondary|Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT|The number of participants with Worst International Society of Heart and Lung Transplant (ISHLT) grade within first 6 months and 12 months PT were reported. ISHLT is a standardized grading method to determine the acute cellular rejection on endomyocardial biopsy ; where 0= no rejection, IA= focal (perivascular or interstitial) infiltrate without necrosis, IB= diffuse but sparse infiltrate without necrosis, II=one focus only with aggressive infiltration and/or focal myocyte damage, IIIA=multifocal aggressive infiltrates and/or myocyte damage, IIIB= diffuse inflammatory process with necrosis, IV= diffuse aggressive polymorphous and/or infiltrate and/or edema and/or hemorrhage and/or vasculitis, with necrosis|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
1298291|NCT00048165|Secondary|Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT|The survival of the graft and participants at 6,12 months and 3 years PT was reported|At 6 months, 12 months , 3 years PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
1298292|NCT00048165|Secondary|Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT|The number of participants with 0,1, 2, 3 or 4 episodes at 6 and 12 months PT were reported. An episode of acute rejection was defined according to the date of positive biopsy of Grade IIIA or worse or the date of start of treatment for HDC, whichever came first.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
1298293|NCT00048165|Secondary|Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT|The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up|Up to 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
1298294|NCT00048165|Primary|Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant|The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up.|Up to 6 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
1298348|NCT00047463|Secondary|Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea|The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization|prior to randomization|These are participants that were enrolled and assessed to determine if one night of baseline sleep study was sufficient to detect sleep apnea. This occurred prior to randomization. Five of the assessed participants were not randomized.|||Participants|||Number
1298295|NCT00048074|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters|Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 – 700 * 10^9/L), low and high white blood cell (WBC) (3.0 - 18.0 * 10^9/L), high alanine aminotransferase (ALAT) (0 – 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 – 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 – 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 – 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L).|Approximately 2 years|Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point. Only participants with data available for the indicated laboratory abnormality were analyzed.|||participants|||Number
1298296|NCT00048074|Secondary|Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Approximately 2 years|Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.|||participants|||Number
1298297|NCT00048074|Secondary|Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
1298298|NCT00048074|Secondary|Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
1298299|NCT00048074|Secondary|Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
1298300|NCT00048074|Secondary|Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
1298301|NCT00048074|Secondary|Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
1298302|NCT00048074|Secondary|Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
1298303|NCT00048074|Secondary|Percentage of Participants With Mean Lumbar Spine (L2 – L4) BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean lumber spine (L2 – L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
1298325|NCT00048061|Secondary|Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD|Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.|From Baseline (Month 0) to Month 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.|||Percent change||Standard Deviation|Mean
1298304|NCT00048074|Secondary|Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.|Baseline, At Month 6, 12, and 24.|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Absolute Change (ng/mL)||Standard Deviation|Mean
1298305|NCT00048074|Secondary|Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.|Baseline, At Month 6, 12, and 24.|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percent Change||Standard Deviation|Mean
1298306|NCT00048074|Secondary|Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24|BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Absolute Change (g/cm^2)||Standard Deviation|Mean
1298307|NCT00048074|Secondary|Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24|BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percent Change||Standard Deviation|Mean
1298308|NCT00048074|Secondary|Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 – L4) at Month 12 and Month 24|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Absolute Change (g/cm^2)||Standard Deviation|Mean
1298309|NCT00048074|Secondary|Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)|Baseline and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percent Change||Standard Deviation|Mean
1298310|NCT00048074|Primary|Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)|Baseline and Month 12|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percent Change||Standard Deviation|Mean
1298311|NCT00048061|Secondary|Number Of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 – 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 – 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].|Up to Month 24|The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.|||Participants|||Number
1298312|NCT00048061|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Event|An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Month 24|The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.|||Participants|||Number
1298313|NCT00048061|Secondary|Absolute Change In Baseline in Serum CTX to Months 12 and 24|Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||ng/ml||Standard Deviation|Mean
1298314|NCT00048061|Secondary|Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).|From Baseline (Month 0) to Months 3, 6, 12, 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
1298315|NCT00048061|Secondary|Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
1298316|NCT00048061|Secondary|Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
1298317|NCT00048061|Secondary|Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
1298318|NCT00048061|Secondary|Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
1298319|NCT00048061|Secondary|Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
1298320|NCT00048061|Secondary|Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
1298321|NCT00048061|Secondary|Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean lumber spine (L2 – L4) BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
1298322|NCT00048061|Secondary|Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.|Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||g/cm2||Standard Deviation|Mean
1298323|NCT00048061|Secondary|Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD|Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
1298324|NCT00048061|Secondary|Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD|The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 – L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||g/cm2||Standard Deviation|Mean
1298326|NCT00048061|Primary|Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 – L4) Bone Mineral Density|Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.|From Baseline (Month 0) to Month 12|The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.|||Percent change||Standard Deviation|Mean
1298327|NCT00048048|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure|Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the SA (Week -3) and Run-in period (Week -2 and Week -1).|From Baseline (Day -28 to Day 1) to Week 125|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1298328|NCT00048048|Secondary|Heart Rate Over Time|Heart rate was defined as the measure of heart beats per minute (bpm). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 125|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||bpm||Standard Deviation|Mean
1298329|NCT00048048|Secondary|Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time|Marked abnormality was defined as above and/or below a value (according to the Roche specified limits) which was considered to be potentially clinically relevant. The Roche reference range are: white blood cells (WBC) (3.0–18.0 10^9 cells/L), platelets (100–550 10^9 cells/L), alanine aminotransferase (ALT) [0-110 units per litre (U/L)], alkaline phosphatase (ALP) (0–220 U/L), aspartate aminotransferase (AST) (0–80 U/L), albumin >= 30 g/L, phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], potassium (2.9 – 5.8 mmol/L), total bilirubin (0-17 µmol/L), lymphocytes (1- 4.80 10^9 cells/L), eosinophils (0 - 0.45 10^9 cells/L), monocytes (0 - 0.8 10^9 cells/L), and neutrophils (1.80 - 7.70 10^9 cells/L). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time, all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 125|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||participants|||Number
1298330|NCT00048048|Secondary|Number of Participants With Any Serious Adverse Events and Any Adverse Events|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 125|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||participants|||Number
1298331|NCT00048048|Secondary|Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen|Reticulocyte levels at EOIT under constant dosing regimen was analysed and reported. Baseline (Day -28 to Day 1) reticulocyte values were calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed reticulocyte count before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The ITT population was defined as all randomized participants. Maximum number of participants with available data was reported.|||Cells x10^3/UL||Inter-Quartile Range|Median
1298332|NCT00048048|Secondary|Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen|Hematocrit (Hct) levels at end of initial treatment under constant dosing regimen were reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The ITT population was defined as all randomized participants. Maximum number of participants with available data was reported.|||g/dL||Inter-Quartile Range|Median
1298333|NCT00048048|Primary|The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes|The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks –2 and –1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants. Maximum number of participants with available data was reported.|||gram/deciliter (g/dL)||Inter-Quartile Range|Median
1298335|NCT00048035|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis|Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week –1).|From Baseline (Day -28 to Day 1) to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||mm HG||Standard Deviation|Mean
1298336|NCT00048035|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0– 18.0 10^9/L), Platelets (100 – 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 – 220 U/L), Aspartate aminotransferase (ASAT) (0 – 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 – 5.8 mmol/L), Glucose (2.80 – 11.10 mmol/L).|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Participants|||Number
1298337|NCT00048035|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Participants|||Number
1298338|NCT00048035|Secondary|Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants.|||g/dL||Inter-Quartile Range|Median
1298339|NCT00048035|Primary|Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week –1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants.|||g/dL||Inter-Quartile Range|Median
1298340|NCT00047879|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|4 months||||Participants|||Number
1298341|NCT00047879|Secondary|Number of Participants With Complete or Partial Response|"Response is defined per RECIST criteria. Measurable disease is defined as bidimensionally measurable lesions with clearly defined margins by CT or MRI scan.~Evaluable disease is defined as unidimensionally measurable lesions, masses with margins not clearly defined, or lesions with a multiple cystic component.~Complete response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products or perpendicular diameters of all measurable lesions."|6 months|Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.|||Participants|||Number
1298342|NCT00047879|Primary|Progression-free Survival|"Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy.~Progression of disease by > 50% increase in the size of the tumor compared to baseline after the first cycle only, and then >25% increase in the size of the tumor for all subsequent cycles."|6 months|The primary objective was not met. Only registered 7 out of 64 participants and they all came off the study for progressive disease around 3-4 months after starting the study. None of the participants were evaluated for progression-free survival at 6 months because the study was stopped at 4 months due to progressive disease.|||Percent of participants|||Number
1298343|NCT00047697|Primary|Cognitive Assessment: CVLT|California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better|8 weeks||||percentage of correct answers||Standard Deviation|Mean
1298344|NCT00047697|Primary|Cognitive Assessment: EOWVT Standard Score|Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better|8 weeks||||units on a scale||Standard Deviation|Mean
1298345|NCT00047697|Primary|Cognitive Assessment: TMT|TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better|8 weeks||||seconds||Standard Deviation|Mean
1298346|NCT00047619|Primary|Pressure Ulcer Volume Measurement|Volume of pressure ulcer was measured by the amount of fluid that could be used to fill the pressure ulcer which was covered by an occlusive dressing|study participation - up to 6 weeks||||cm^3||95% Confidence Interval|Mean
1298347|NCT00047619|Primary|Pressure Ulcer Geometry|Linear assessment of wounds|study participation - up to 6 weeks||||cm||95% Confidence Interval|Mean
1298350|NCT00047463|Primary|CPAP Adherence/Tolerance as Measured by Proportion of Nights Used|This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.|10 weeks||||proportion of nights used (total nights||Standard Deviation|Mean
1298351|NCT00046475|Primary|Post-treatment OHSA Item 1 Score of US Participants With Marked/Severe Disease According to The CGI-S Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Marked or Severe disease severity. Higher scores indicate more severe disease.|End of 2-week treatment period|Randomized participants enrolled at any of the 28 US sites|||scores on a scale||Standard Deviation|Mean
1298352|NCT00046475|Primary|Post-treatment OHSA Item 1 Score of United States (US) Participants With Mild/Moderate Disease According to The Clinical Global Impressions-Severity (CGI-S) Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Mild or Moderate disease severity. Higher scores indicate more severe disease.|End of 2-week treatment period|Randomized participants enrolled at any of the 28 US sites|||scores on a scale||Standard Deviation|Mean
1298353|NCT00046475|Secondary|Convergent Validity of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA and the OHSA composite score were analyzed for convergent validity with the CGI-I-Clinician scores. The change from baseline in the CGI-I scores are correlated with the OHSA Item 1 score change from baseline and the OHSA composite score change from baseline for the subjects in the ITT population. Values shown are Spearman correlation coefficients.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||correlation coefficient|||Number
1298354|NCT00046475|Secondary|Responsiveness of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for responsiveness as a measure of validity. Assuming that subjects who received Placebo during Randomization Period 1 are stable between Visit 3A and Visit 5, and using them as the stable subjects, responsiveness was calculated as [(OH CFB in Midodrine group)-(OH CFB in Placebo group)]/(SD of OH CFB in Placebo group), where CFB is change from baseline, SD is the standard deviation of OH CFB of the stable subjects; the value reported is the quotient of this equation.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||quotient|||Number
1298355|NCT00046475|Secondary|Test Reliability of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for test-retest reliability as a measure of validity. Test-retest reliability is the Pearson product-moment correlation coefficient calculated between OHQ scores at Visit 3A (baseline measure) and OHQ scores at Visit 5 for the subjects who received Placebo during Randomization Period 1.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||correlation coefficient|||Number
1298356|NCT00046475|Secondary|Change From Baseline in Short Form-36 (SF-36) Version 2 Health Survey Questionnaire Scores|"The SF-36 consists of 36 items in eight domains: physical functioning, general health, role-physical, bodily pain, vitality, social functioning, role-emotional, and mental health. Version 2 references one week ago for some questions. Raw scale scores for the SF-36 were transformed to a 0-100 scale with a higher score indicating a better quality of life. A positive change from baseline indicates that symptoms have improved. The SF-36 was completed at Visit 5 (Period 2) and Visit 6 (study completion) and compared to the score from Visit 3A (titration)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
1298357|NCT00046475|Secondary|Change From Baseline in Supine BP|Supine BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Supine BP was measured after the patient had been in the supine position for 5 minutes.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||mmHg||Standard Deviation|Mean
1298358|NCT00046475|Secondary|Change From Baseline in Standing Blood Pressure (BP)|Standing BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Standing BP was measured 3 minutes after the patient rose from the supine position or as soon as the patient indicated they needed to sit down. If the patient indicated he or she needed to sit down, the BP measurement was taken while in the standing position, before the patient sat down.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||mmHg||Standard Deviation|Mean
1298369|NCT00046566|Primary|Change From Baseline in Average Systolic Blood Pressure at 8 Weeks|The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from two baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements.|Every 8 weeks|participants took soy protein during three phases|||mmHg||95% Confidence Interval|Mean
1298359|NCT00046475|Secondary|Percent of Participants Scored as Improved on The Patient Version of The CGI-I Scale|"The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of Overall Improvement. The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||percent of participants|||Number
1298360|NCT00046475|Secondary|Percent of Participants Scored as Improved on The Clinician Version of The Clinical Global Impressions Improvement (CGI-I) Scale|"The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of Overall Improvement. The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||percent of participants|||Number
1298361|NCT00046475|Secondary|Change From Baseline in The Orthostatic Hypotension Global Daily Activity Score|The OHDAS global daily activity score was calculated as the average of all daily activity item scores. The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH) to activities that required standing for a short time, standing for a long time, walking for a short time, walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
1298362|NCT00046475|Secondary|Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 Scores|The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH). Item 1 addressed activities that required standing for a short time; Item 2, activities that required standing for a long time; Item 3, activities that required walking for a short time; and Item 4, activities that required walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
1298363|NCT00046475|Secondary|Change From Baseline in The OHSA Composite Symptom Score|The OHSA composite symptom score was calculated by taking the average of the ratings for the symptoms present at Baseline. Participants were asked to rate symptoms by using a 0-10 scale (0 meaning not bothered and 10 meaning the worst). For subsequent visits, only those symptoms present at Baseline were scored. In this manner, a score was produced that represents the severity (and subsequent change in severity) of the patient's neurogenic OH symptoms, regardless of how many symptoms are presented at Baseline. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
1298364|NCT00046475|Secondary|Change From Baseline in The OHSA Items 2 Through 6 Scores|Items 2 through 6 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of the following symptoms whenever he or she was standing and that improved when he or she sat down or laid down: Item 2 addresses problems with vision (blurring, seeing spots, tunnel vision, etc); Item 3, weakness; Item 4, fatigue; Item 5, trouble concentrating; and Item 6, head or neck discomfort. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
1298365|NCT00046475|Primary|Re-analysis of The Post-treatment Score For Item 1 of The OHSA Scale, Excluding Two Sites|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.|End of 2-week treatment period|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement. Data for 2 sites were excluded from this re-analysis.|||scores on a scale||Standard Deviation|Mean
1298366|NCT00046475|Primary|Post-treatment Score For Item 1 of The Orthostatic Hypotension Symptom Assessment (OHSA) Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.|End of 2-week treatment period|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
1298367|NCT00046566|Secondary|Body Weight at 8 Weeks|Body weight was measured by trained staff using a standard protocol at week 8.|Every 8 weeks|Participants took supplementation for 8 weeks|||kg||95% Confidence Interval|Mean
1298368|NCT00046566|Secondary|Change From Baseline in Serum LDL-cholesterol at 8 Weeks|Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method.|Every 8 weeks|Participants took soy protein for 8 weeks|||mg/dL||95% Confidence Interval|Mean
1298370|NCT00046228|Other Pre-specified|Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7|Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.|Discharge/Day 7|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.|||participants|||Number
1298371|NCT00046228|Other Pre-specified|Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7||Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.|||participants|||Number
1298372|NCT00046228|Other Pre-specified|Subjects With Severe Thrombocytopenia Through Discharge/Day 7|Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.|||participants|||Number
1298373|NCT00046228|Other Pre-specified|Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7|Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.|||participant|||Number
1298374|NCT00046228|Other Pre-specified|Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7|All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.|||participants|||Number
1298375|NCT00046228|Secondary|All-Cause Mortality Through 1 Year|All-cause mortality through 1 year from randomization.|1 year|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.|||participants|||Number
1298376|NCT00046228|Secondary|Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization||60 to 90 minutes|Population is the intent-to-treat subjects who were selected for evaluation by electrocardiogram (ECG) core laboratory.Subjects, who were not evaluable for a 60-90 minute ECG, were considered not having a ST segment resolution.|||participants|||Number
1298377|NCT00046228|Secondary|All-Cause Mortality Through 90 Days|All cause mortality occurred through 90 days from randomization.|90 days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.|||participants|||Number
1298378|NCT00046228|Secondary|Complications of MI as Defined in the Primary Outcome Measure Through 90 Days|The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.|90 Days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects that have been randomly assigned to a treatment group and classified according to the randomization assignment.|||participants|||Number
1298379|NCT00046228|Primary|The Composite of All-Cause Mortality or Complications of MI at 90 Days.|Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization).|90 days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment.|||participants|||Number
1298380|NCT00045942|Secondary|Overall Survival (E2)|OS was measured from the date of the first dose of treatment to the date of death from any cause or the last date the patient was known to be alive (censored observation)|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..|||days||95% Confidence Interval|Median
1298381|NCT00045942|Secondary|Time to Disease Progression (E2)|TTP was defined as the time from the first dose date to the date of disease progression, which was defined as the study completion date for unsatisfactory treatment effect, the date of response assessment of progressive disease, or the date of death from any cause|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..|||days||95% Confidence Interval|Median
1298382|NCT00045942|Secondary|Best Clinical Response (E2)|Best clinical response was defined as CR, PR, MR, MR+BR, or BR . CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..|||Participants|||Number
1298394|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, were considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
1298383|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
1298384|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
1298385|NCT00045942|Secondary|Summary of PKC412 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
1298386|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration for 50 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
1298387|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration for 50 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
1298388|NCT00045942|Secondary|Summary of PKC412 Plasma Concentration for 50 mg Twice Daily (Bid) Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
1298389|NCT00045942|Secondary|Event-free Survival (E1)|Event-free survival was defined as the time from date of start of treatment to the date of death from any cause, treatment failure or relapse|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||days||95% Confidence Interval|Median
1298390|NCT00045942|Secondary|Duration of Best Clinical Response (E1)|Duration of best clinical response was measured from the time that the measurement criteria were met for CR, PR, MR (with or without blast reduction) or BR until the first date that recurrent disease was documented (event) or until the date of last follow up.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Responders from the PEP; PEP defined as all patients who received at least 1 dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||days||95% Confidence Interval|Median
1298391|NCT00045942|Secondary|Overall Survival (OS) (E1)|OS was measured from the date of the first dose of treatment to the date of death from any cause or to the last date that the patient was known to be alive (a censored observation).|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||days||95% Confidence Interval|Median
1298392|NCT00045942|Secondary|Time to Disease Progression (E1)|TTP was defined as the time from the first dose date to the date of disease progression (defined as the study completion date for unsatisfactory treatment effect, date of response assessment of progressive disease, or date of death from any cause). One participant from the wild type 200 mg group did not have any assessment on treatment and therefore was not taken into account for TTP.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||days||95% Confidence Interval|Median
1298393|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, were considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
1298810|NCT00023595|Secondary|H02: LVEF by ECHO Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab|From randomization to 24 months follow-up|Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
1298396|NCT00045942|Secondary|Time to Disease Progression (TTP) (Core)|TTP was defined as the time from first dose date to date of disease progression which is identified as study completion date for unsatisfactory treatment effect or date of death from any cause within the 28 day cutoff post treatment.|from date of FPFV, 29-Jan-2002, to date of LPLV, 04-Sep-2003|Core primary efficacy population: The core primary efficacy population included all participants who were randomized.|||days||95% Confidence Interval|Median
1298397|NCT00045942|Primary|Summary of CGP52421 Concentration (E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Full Range|Median
1298398|NCT00045942|Primary|Summary of CGP62221 Concentration (E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Full Range|Median
1298399|NCT00045942|Primary|Summary of Midostaurin Concentration in the PKC412 Dose Escalation Arms(E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Full Range|Median
1298400|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
1298401|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||hour||Full Range|Median
1298402|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP52421 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
1298403|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP52421 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
1298404|NCT00045942|Primary|Terminal Elimination Half-life (T1/2) for CGP62221 in the PKC + Itrconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: day 22,|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For this end point, 4 participants with non-missing values were analyzed.|||hour||Standard Deviation|Mean
1298405|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP622221 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
1298406|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP62221 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||hour||Full Range|Median
1298407|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP62221 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
1298408|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP62221 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
1298409|NCT00045942|Primary|Terminal Elimination Half-life (T1/2) for PKC412 in the PKC + Itrconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21 and 22|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||hour||Standard Deviation|Mean
1298410|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
1298411|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||hour||Full Range|Median
1298412|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for PKC412 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
1298413|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for PKC412 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
1298414|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (E2)||Days 1, 28|The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting.||||||
1298415|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (E1)||days 1, 28|The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting.||||||
1298416|NCT00045942|Primary|Number of Participants With Overall Clinical Response (E1)|Overall clinical response was defined as CR, PR, minor response (MR) or blast response (BR). CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|E1 primary efficacy population: all participants who received at least one dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||Participants|||Number
1298417|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (Core)||days 1, 28|This outcome measure was not analyzed. Assessment of FLT3 autophosphorylation in leukemic blasts was not possible at the planned time points because the blast reduction was rapid and occurred during the first week in some participants. Thus, by Day 28, the blast count in some participants were too low for autophosphorylation to be measured.||||||
1298418|NCT00045942|Primary|Number of Participants With Best Clinical Response (Core)|Best clinical response was defined as complete response (CR) or partial response (PR), according to NCI definitions for AML and the guidelines for defining responses in MDS.|from date of first patient first visit (FPFV), 29-Jan-2002, to date of last participant last visit (LPLV), 04-Sep-2003|Core primary efficacy population: The core primary efficacy population included all participants who were randomized.|||Participants|||Number
1298419|NCT00044655|Secondary|Psychiatric Symptoms, Hospitalization, and Medication Side Effects||Measured at Year 1|||||||
1298420|NCT00044655|Primary|Number Who Discontinued Medication Within First 6 Study Months||Measured at Six Months|intent to treat samples for 2 substudies: injectable to injectable and polypharmacy to monotherapy|||participants|||Number
1298421|NCT00044512|Secondary|Overall Survival|Time from the first date of receiving study medication to death.|Start of treatment to death|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
1298422|NCT00044512|Secondary|Duration of Minor Response|Time from the date that MR was first documented to the date that PD was first documented.|Time from MR to PD|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||Full Range|Mean
1298423|NCT00044512|Secondary|Time to Minor Response|Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
1298424|NCT00044512|Secondary|Duration of Stable Disease|Time from the first day of receiving study drug until there was a documented PD or response.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
1298427|NCT00044512|Secondary|Duration of Response|Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and C status (positive vs negative). The 3 subjects are censored at time of evaluation. The Median is not estimable so the reported number is biased.|||days||Full Range|Median
1298428|NCT00044512|Primary|Percentage of Participants for Each Type of Response|Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.|Until 30 days after termination of active therapy|Intention to Treat (ITT) analyses were performed on subgroups of patients categorized by baseline characteristics of ECOG Performance Status, Child Pugh status, TNM stage at study entry, prior surgical procedure, hepatitis A and B status, and age.|||percentage of participants|||Number
1298429|NCT00044213|Secondary|A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.|Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used.|Measured over a maximum 5-year follow-up period- 55 month median||||participants|||Number
1298430|NCT00044213|Primary|A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.|Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.|Measured over a maximum 5-year follow-up period- 55 month median||||participants|||Number
1298431|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores|The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.|||units on scale||Standard Error|Least Squares Mean
1298432|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores|The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.|||units on a scale||Standard Error|Least Squares Mean
1298433|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores|The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.|||units on a scale||Standard Error|Least Squares Mean
1298434|NCT00044044|Primary|Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score|"The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia."|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.|||units on a scale||Standard Error|Least Squares Mean
1298435|NCT00044005|Primary|Number of Participants With Adverse Events|The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.|6-months|No formal hypothesis testing was performed. However,descriptive statistics were provided and data summarized. Safety analyses were conducted on the safety population, that included all subjects who had received at least 1 dose of open-label study medication.|||participants|||Number
1298436|NCT00044083|Secondary|Positive and Negative Syndrome Scale|Rating Scales PANSS. The Positive Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The Negative Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The General Scale ranges from 16 to 112, the higher score indicating greater severity of symptoms.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|There were 74 Healthy Volunteers and 33 Patients with Schizophrenia|||units on a scale||Standard Deviation|Mean
1298437|NCT00044083|Primary|N-Back Task Activation by Genotype in Patients With Schizophrenia|Activation beta values (N-Back vs. 0-Back) extracted from DLPFC from the contrast maps in Patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|33 patients with schizophrenia|||beta value||Standard Error|Mean
1298438|NCT00044083|Primary|N-Back Task Activation Genotype Effect in Healthy Volunteers|Activation beta values (N-Back vs. 0-Back) extracted within the Effect of Genotype cluster around the peak (p < 0.05 uncorrected) in right and left DLPFC from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)||||beta value||Standard Error|Mean
1298439|NCT00044083|Primary|N-Back Task Activation in Healthy Volunteers|Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|74 Healthy Volunteers|||beta value||Standard Error|Mean
1298440|NCT00044083|Primary|N-Back Task Activation in DLPFC in Patients With Schizophrenia|Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps in patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|33 Patients with Schizophrenia|||beta value||Standard Error|Mean
1298441|NCT00044083|Primary|N-Back Task Activation Drug Effect|Activation beta values (N-Back vs. 0-Back) extracted within the Main Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps across both groups. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|74 Healthy Volunteers and 33 Patients with Schizophrenia|||beta value||Standard Error|Mean
1298442|NCT00044083|Primary|N-Back Task Activation Diagnosis Effect|Activation beta values (N-Back vs. 0-Back) were extracted within the Main Effect of Diagnosis cluster around the peak (p < 0.05 uncorrected) from the contrast maps in the Placebo condition. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|74 Healthy Volunteers and 33 Patients with Schizophrenia|||beta value||Standard Error|Mean
1298443|NCT00044083|Primary|N-Back Task Performance|Working Memory was measured in HVs and patients with schizophrenia after a 7-day treatment with Tolcapone or placebo in a double-blind, cross-over fashion. The working memory was quantified by taking the number of trials entered correctly divided by the total number of trials multiplied by 100. Values range from 0 to 100. Zero indicates the poorest performance while 100 indicates perfect performance.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|147 HV’s recruited, 8 left after signing consents, 8 excluded for other reasons, 57 excluded for excessive motion, inferior quality or not completion. 63 patients recruited, 4 removed for different reasons, 26 excluded from image analyses for not completing the second phase of the study, excessive motion or bad image quality.|||% of Correct Trials||Standard Error|Mean
1298444|NCT00043979|Other Pre-specified|Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy|Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria.|up to 6 cycles or 168 days|G1, grade 1; G2, grade 2; G3, grade 3; G4, grade 4; G5, grade 5. 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Participants|||Count of Participants
1298445|NCT00043979|Other Pre-specified|Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)|GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy.|up to day 100|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Participants|||Count of Participants
1298446|NCT00043979|Secondary|Median Survival From Date of Progression|Median survival from date of progression is based on the time from on-study date until progression or last follow-up.|up to 77 months|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Months||Full Range|Median
1298447|NCT00043979|Secondary|Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)|Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is >75% reduction in disease) was also employed.|up to 10 cycles of therapy or 280 days|EPOCH-F (Etoposide, Vincristine, Prednisone, Cyclophosphamide, Doxorubicin, and Fludarabine) was modified to EOCH and administered to 12 patients for post-transplantation disease progression.|||Participants|||Count of Participants
1298448|NCT00043979|Secondary|Cluster of Differentiation 4 (CD4) Reconstitution|The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing.|Day +28-42||||mm(3)||Full Range|Median
1298449|NCT00043979|Secondary|Number of Participants to Complete Conversion to >95% Donor Chimerism|Participants who tolerated the transplantation regimen and accepted >95% of the donors blood, marrow, and/or tissue.|up to 30 days|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Participants|||Count of Participants
1298450|NCT00043979|Secondary|Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant|Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant.|2 years|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||percentage of participants|||Number
1298451|NCT00043979|Secondary|Median Progression Free Survival|Progression free survival was based on the time from on-study date until progression or last follow-up.|up to 77 months|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Months||Full Range|Median
1298457|NCT00043979|Primary|Number of Participants With Engraftment|Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, >95% donor engraftment at day 100 in >75% of patients.|100 days|"E.g ...in >75% of patients, shown above is not a conclusion but refers to a hypothesis, the objective of the protocol.~23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling."|||Participants|||Number
1298458|NCT00043550|Primary|Hamilton Rating Scale for Depression-17 Item|Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.|symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16|Numbers vary from consented due to dropout prior to start of study. 156 patients consented and randomized. 11 patients did not complete at least one post-randomization measure and were therefore not included in these analyses.|||units on a scale||Standard Deviation|Mean
1298459|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Inter-Quartile Range|Median
1298460|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Inter-Quartile Range|Median
1298461|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Inter-Quartile Range|Median
1298462|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Inter-Quartile Range|Median
1298463|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Inter-Quartile Range|Median
1298464|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Standard Error|Least Squares Mean
1298465|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Standard Error|Least Squares Mean
1298466|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Standard Error|Least Squares Mean
1298467|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Standard Error|Least Squares Mean
1298468|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
1298469|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing baseline and non-missing value at Month 48.|||Percent change||Standard Error|Least Squares Mean
1298470|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Standard Error|Least Squares Mean
1298471|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Standard Error|Least Squares Mean
1298811|NCT00023595|Secondary|H01: LVEF by ECHO Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab|From randomization to 24 months follow-up|Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
1298472|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Standard Error|Least Squares Mean
1298473|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
1298474|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Standard Error|Least Squares Mean
1298475|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Standard Error|Least Squares Mean
1298476|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Standard Error|Least Squares Mean
1298477|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Standard Error|Least Squares Mean
1298478|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
1298479|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 48|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Inter-Quartile Range|Median
1298480|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 42|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Inter-Quartile Range|Median
1298481|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 36|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Inter-Quartile Range|Median
1298482|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 24|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Inter-Quartile Range|Median
1298483|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 48|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Inter-Quartile Range|Median
1298484|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 42|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participantswith non-missing Baseline and non-missing value at Month 42.|||Percent change||Inter-Quartile Range|Median
1298485|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 36|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Inter-Quartile Range|Median
1298486|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 24|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Inter-Quartile Range|Median
1298487|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Standard Error|Least Squares Mean
1298488|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Standard Error|Least Squares Mean
1298489|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Standard Error|Least Squares Mean
1298490|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Standard Error|Least Squares Mean
1298491|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
1298492|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 12|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Inter-Quartile Range|Median
1298493|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 12|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12|||Percent change||Inter-Quartile Range|Median
1298494|NCT00043186|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
1298495|NCT00042432|Secondary|Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase|Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase|Baseline, efficacy assessment phase (weeks 12-18)|All randomized participants, using Last Value Carried Forward (LVCF) imputation|||Percent change||Standard Error|Mean
1298496|NCT00042432|Primary|Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase|Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase|Efficacy assessment phase (weeks 12-18)|All randomized participants, using Last Value Carried Forward (LVCF) imputation|||Participants|||Number
1298497|NCT00042224|Primary|Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.|Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which is 40% less than participants baseline score. If a participant enters the study with a sub-scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.|8 Weeks|inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y.|||Percentage of responders|||Number
1298498|NCT00041938|Other Pre-specified|Rate Per 100 Patient-years of Minor Hemorrhage.|Rate per 100 patient years of minor hemorrhage. Includes all minor hemorrhages. Minor hemorrhage was defined as any non-major hemorrhage. Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.|From date of randomization until the end of scheduled follow-up, up to 6 years|Intent-to-treat|||events per 100 patient-years|||Number
1298499|NCT00041938|Other Pre-specified|Rate Per 100 Patient Years of Major Hemorrhage|Rate/100 patient-years of major hemorrhage. Includes all major hemorrhages in any patient. Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention. Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization until end of scheduled follow-up, up to 6 years|Intent-to-treat|||events per 100 patient years|||Number
1298500|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome|Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of death component of secondary composite outcome, up to 6 years|Intent-to-treat|||events per 100 patient years|||Number
1298511|NCT00041756|Primary|Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment|The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.|baseline and 12 months|"An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.~analysis."|||mm||Standard Error|Least Squares Mean
1298501|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome|Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years|Intent-to-treat|||events per 100 patient years|||Number
1298502|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome|Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.|From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years|Intent-to-treat.|||events per 100 patient years|||Number
1298503|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.|Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years|Intent-to-treat.|||events per 100 patient years|||Number
1298504|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome|Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years|Intent-to-treat|||events per 100 patient years|||Number
1298505|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Death|Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of death component of primary composite outcome, up to 6 years|Intent-to-treat|||events per 100 patient-years|||Number
1298506|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Intracerebral Hemorrhage|Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years|Intent-to-treat|||rate per 100 patient years|||Number
1298507|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Ischemic Stroke|Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years|Intent-to-treat|||rate per 100 patient years|||Number
1298508|NCT00041938|Secondary|Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.|"The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.~Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25."|From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.|Intent-to-treat analysis: all enrolled patients were analyzed.|||events per 100 patient-years|||Number
1298509|NCT00041938|Primary|Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death|The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years|Intent-to-treat analysis: all enrolled patients were analyzed.|||events per 100 patient-years|||Number
1298510|NCT00041756|Primary|Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year|The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)|baseline and 12 months|An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1298512|NCT00041717|Primary|Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment|This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.|Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98|ITT|||units on a scale||Standard Error|Mean
1298513|NCT00041717|Primary|Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity|The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.|Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98|Intent to treat (ITT) population|||units on a scale||Standard Error|Mean
1298514|NCT00041470|Secondary|To Measure the Qualitative and Quantitative Toxicity of This Regimen.||<=18 months||||Participants|||Count of Participants
1298515|NCT00041470|Primary|To Measure Response Rates, Time to Progression and Survival in Patients so Treated.||1 year||||Participants|||Count of Participants
1298516|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: Ctau|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||microgram per milliliter||95% Confidence Interval|Least Squares Mean
1298517|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: Cmax|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||micrograms/milliliters||95% Confidence Interval|Least Squares Mean
1298518|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: AUC0-tau|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||hours*micrograms/milliliters||95% Confidence Interval|Least Squares Mean
1298519|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: t1/2|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. t1/2=elimination half-life. t1/2=elimination half-life."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||hours||95% Confidence Interval|Geometric Mean
1298520|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: CL/F|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||milliliters/minute||95% Confidence Interval|Geometric Mean
1298521|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: CL/F|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||milliliters/minute/kilogram||95% Confidence Interval|Geometric Mean
1298522|NCT00040664|Primary|Median Steady State Plasma APV Tmax|tmax: time after administration of the drug when maximum concentration is reached|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||hours||Full Range|Median
1298547|NCT00039741|Secondary|Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy|25th Percentiles in weeks from randomization HIV-1 RNA of 400 copies/ml or greater during first-line therapy or permanent discontinuation of first-line therapy.|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||Weeks (25th Percentile)|||Number
1298523|NCT00040664|Secondary|Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class. Virologic failure is defined as HIV-1 RNA greater than or equal to 400 copies/mL.|Time of virologic failure|Participants in the ITT-E Population who met the virologic failure definition. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.|||Participants|||Number
1298524|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: Cmax|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. Cmax= concentration maximum."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||micrograms/milliliter||95% Confidence Interval|Geometric Mean
1298525|NCT00040664|Primary|Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. AUC(0-tau)=area under the concentration curve from time 0 to tau."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The Pharmacokinetic (PK) Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||hours*micrograms/milliliter||95% Confidence Interval|Geometric Mean
1298526|NCT00040664|Primary|Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities|The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug|||Participants|||Number
1298527|NCT00040664|Primary|Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event|The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug|||Participants|||Number
1298528|NCT00040664|Secondary|Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits|A blood sample was drawn to determine the CD4+ cell count at Weeks 24, 48, 96, and 168. Change from Baseline was defined as the CD4+ cell count at Weeks 24, 48, 96, and 168 minus the CD4+ cell count at Baseline.|Baseline and Weeks 12, 48, 96, and 168|ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.|||Cells/mm3||Inter-Quartile Range|Median
1298529|NCT00040664|Secondary|Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 12, 24, 48, 96, and 168. Change from Baseline was defined as the HIV-1 RNA level at Weeks 12, 24, 48, 96, and 168 minus the HIV-1 RNA level at Baseline.|Baseline and Weeks 12, 48, 96, and 168|ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.|||log10 copies/mL||Inter-Quartile Range|Median
1298530|NCT00040664|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies per milliliter (mL) at Weeks 12, 48, 96, and 196. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 12, 48, 96, 168 was determined by the TLOVR algorithm with stratification by the six randomization strata. TLOVR analysis categorizes participants by treatment response. Responders were participants with confirmed viral load <400copies/mL on two consecutive visits.|Weeks 12, 48, 96, and 168|The Intent-to-Treat Exposed (ITT [E]) Population consisted of all subjects with documented evidence of having received at least one dose of study drug. Results are stratified by previous protease inhibitor (PI) experience. Participants with previous PI experience may respond differently to FPV.|||percentage of participants|||Number
1298531|NCT00040664|Primary|Number of Participants Who Discontinued Treatment Due to Adverse Events|The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug|||Participants|||Number
1298532|NCT00041392|Primary|Cognitive Function|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.|Measured at baseline and 6 weeks||||Continuous cognitive change score||Standard Deviation|Mean
1298548|NCT00039741|Secondary|Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen)|25th Percentiles in weeks from randomization to starting an alternative class ART regimen (based on initial randomized regimen)|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||Weeks (25th Percentile)||Inter-Quartile Range|Median
1298549|NCT00039741|Secondary|Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death||Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||participants|||Number
1298533|NCT00040443|Primary|15-Item Word List Delayed Recall|"The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI.~The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled."|28 Days|Intent to Treat (ITT)|||units on a scale - change from baseline||Standard Deviation|Mean
1298534|NCT00040365|Secondary|Number of Participants Who Had Proctoscopic Examinations|Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis.|3 years||||Participants|||Number
1298535|NCT00040365|Secondary|Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)|Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined.|Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18||||scores on a scale||Full Range|Mean
1298536|NCT00040365|Secondary|Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)|The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf|18 months||||scores on a scale||Standard Deviation|Mean
1298537|NCT00040365|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|3 years||||Participants|||Number
1298538|NCT00040365|Secondary|Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.|A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx.|The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment.||||Percentage of Participants|||Number
1298539|NCT00040365|Primary|Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.|A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx|RTOG Acute was used on week 5 and 7|Number of participants 29 versus 30 = One patient was taken off study due to tumor progression prior to the follow up period.|||Percentage of Participants|||Number
1298540|NCT00039871|Secondary|Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12|Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up|24 weeks posttreatment|Participants with detectable but >=2 log drop in HCV-RNA at Treatment Week 12|||Participants|||Number
1298541|NCT00039871|Secondary|Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12|Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up|24 weeks posttreatment|Participants who had undetectable HCV-RNA at Treatment Week 12|||Participants|||Number
1298542|NCT00039871|Primary|Sustained Virologic Response (SVR) Rate|Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)|Assessed at end of 24 weeks posttreatment follow-up|Participants who received at least one dose of study medication|||Participants|||Number
1298543|NCT00039741|Secondary|Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks||24 weeks|Intent to treat - numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 24.|||participants|||Number
1298544|NCT00039741|Secondary|Change in CD4% From Randomization to 4 Years||Randomization to 4 years|Intent to treat, for participants who had CD4% values available at 4 years and at baseline.|||CD4 percent (% of total lymphocytes)||Standard Deviation|Mean
1298545|NCT00039741|Secondary|Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204||Week 204|Intent to treat. Numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 204.|||participants|||Number
1298546|NCT00039741|Secondary|Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy|25th Percentiles in weeks from randomization to HIV-1 RNA of 30,000 copies/ml or greater during second-line therapy or permanent discontinuation of second-line therapy|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||Weeks (25th Percentile)|||Number
1298550|NCT00039741|Secondary|Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced|"Adverse events were graded according to the following guidelines:~PACTG: “The Manual for Expedited Reporting of Adverse Events to DAIDS” (DAIDS EAE Manual) dated May 6, 2004.~PENTA: International Conference for Harmonization (ICH) requirements and the EU Clinical Trials Directive 2001/20/EC (20).~A rating of Grade 3 is severe and Grade 4 is life-threatening. The rate of serious (Grade 3 or above)events is reported as the number of events per 100 child/years."|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||events/100 child-years||95% Confidence Interval|Mean
1298551|NCT00039741|Primary|Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml||Baseline visit and 4 years after Study Entry|Intent-to-treat analyses for those subjects who had data at baseline and 4 years. Analyses were done by collapsing groups to examine drug class (regardless of switch point) and switch point (regardless of drug class).|||log10 HIV-1 RNA||Standard Error|Mean
1298552|NCT00038948|Secondary|First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.|Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).|52 and 104 weeks|Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.|||patients|||Number
1298553|NCT00038948|Primary|Nankivell Glomerular Filtration Rate (GFR)|Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.|52 weeks|Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.|||mL/min||Standard Error|Mean
1298554|NCT00038857|Primary|Number of Participants With Absolute Neutrophil Count Engraftment|Absolute neutrophil engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Baseline to Day 30 post transplant.|Day 0 up to Day 30|Analysis per protocol.|||participant|||Number
1298555|NCT00038727|Secondary|Quality of Life and Economic Analyses|Quality of life measurements include Beck, SF-36, and QWB.|2002-2013|||||||
1298556|NCT00038727|Secondary|Subclinical Atherosclerosis|Measured using coronary artery calcification.|2012|||||||
1298557|NCT00038727|Secondary|Aging Related Outcomes - Cognitive and Physical Function|Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ). Physical function assessed with the same two well-validated composite measures : the Short Physical Performance Battery (SPPB) and the Cardiovascular Health Study Frailty criteria. The SPPB is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands. Frailty is classified based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.|2010 and 2012|||||||
1298558|NCT00038727|Secondary|Microvascular and Cardiovascular Disease Risk Factors|Blood pressure, lipids, medication use, weight, insulin resistance, HbA1c, physical activity by MAQ.|2021||2022-04-30|04/2022||||
1298559|NCT00038727|Primary|MACE|Defined as MI, stroke and CVD death|1996-2025||2025-06-30|06/2025||||
1298560|NCT00038727|Primary|Total Cancer Except Non-melanoma Skin Cancer|All primary incident cancers except non-melanoma skin cancer|1996-2021||2021-06-30|06/2021||||
1298561|NCT00038727|Primary|Prevalence of Aggregate Microvascular Complication|Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on eGFR by CKD-Epi (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).|2012-2013|Number with microvascular outcome data and included in the primary outcome analysis|||average percentage of participants||95% Confidence Interval|Number
1298562|NCT00038727|Primary|Development of Diabetes.|Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram OGTT, and confirmed with a repeat test).|2008||||diabetes incidence (cases per 100 person||95% Confidence Interval|Number
1298563|NCT00038649|Secondary|Participant Complete Hematologic Remission (CHR) Classified|Number of participants with Complete Hematologic Remission (CHR): normalization >4 weeks of bone marrow (<5% blasts), peripheral blood with WBC <10 x 109/L & no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. CHR further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or i Fluorescence In Situ Hybridization (FISH): No cytogenetic response - Ph positive 100% of pretreatment value; Minor cytogenetic response - Ph positive 35-90% of pretreatment value; Partial cytogenetic response - Ph positive 1-34% of pretreatment value; Complete cytogenetic response - Ph positive 0%. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.|Response to imatinib mesylate evaluated after completing 3 - 12 months of therapy.|Analysis was of the 110 participants who achieved a CHR with a cytogenetic response as described in the outcome measure descriptions.|||participants|||Number
1298564|NCT00038649|Primary|Number of Participants With Molecular Response of Complete or Partial Hematologic Remission|Complete Hematologic Remission (CHR): normalization >4 weeks of bone marrow (<5% blasts), peripheral blood with White Blood Cells (WBC) <10 x 109/L & no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly < 50% of pretreatment, or thrombocytosis >450x109/L but <50% of pretreatment. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.|Response to imatinib mesylate evaluated after completing 3 - 12 months of therapy.||||participants|||Number
1298565|NCT00038610|Primary|Disease-Free Survival Rate at 2-year and 5-year.|Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.|Baseline to 2-year and 5-year||||percentage of participants|||Number
1298566|NCT00038610|Secondary|Overall Survival Rate at 2-year and 5-year.|Overall survival (OS) was calculated from the date of initiation of therapy until death.|Baseline to 2-year and 5-year||||percentage of participants|||Number
1298812|NCT00023595|Secondary|H02: Exercise Duration|Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test|From randomization to 24 months follow-up|Only patients with exercise duration data at baseline or 24 months were analyzed.|||meters||Standard Deviation|Mean
1298567|NCT00038610|Primary|Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate|"Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease.~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.~Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl.~Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease."|Baseline to 6 months|Of the 54 participants, 39 (72%) presented with de novo disease, 6 (11%) were refractory to standard induction therapy, and 9 (17%) entered the study in complete remission (CR) after one course of standard induction therapy.|||participants|||Number
1298568|NCT00038467|Secondary|Number of Participants With Histological Findings: Endometrial Sub-study||Baseline up to 24 months post-treatment|Results were not reported for this outcome measure because no data was collected as per change in planned analysis.||||||
1298569|NCT00038467|Secondary|Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study|Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.|Baseline up to 24 months post-treatment|As treated population included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.|||percentage of participants|||Number
1298570|NCT00038467|Secondary|Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study|Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of ‘yes’, ‘no’ or ‘missing’ (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study. Analysis was based on actual treatment received. 'n' signifies those participants who were evaluable for this measure at given time points for each group,respectively.|||participants|||Number
1298571|NCT00038467|Secondary|Uterine and Overall Ovary Volume: Endometrial Sub-study|Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(2*1000). Ovary volume = [(longitudinal diameter * transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.|||cubic centimeter (cm^3)||Full Range|Median
1298572|NCT00038467|Secondary|Endometrial Thickness: Endometrial Sub-study|Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.|||mm||Full Range|Median
1298573|NCT00038467|Secondary|Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study|Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.|||percentage of participants|||Number
1298574|NCT00038467|Secondary|Number of Participants With Severe Endocrine Symptoms: QoL Sub-study|Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories “quite a bit” and “very much”) were presented.|Baseline up to 24 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||participants|||Number
1298587|NCT00038467|Secondary|Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
1298575|NCT00038467|Secondary|Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
1298576|NCT00038467|Secondary|Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
1298577|NCT00038467|Secondary|Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
1298578|NCT00038467|Secondary|Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy|The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
1298579|NCT00038467|Secondary|Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
1298580|NCT00038467|Secondary|Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
1298581|NCT00038467|Secondary|Change From Baseline in Total Functional Assessment of Cancer Therapy – General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
1298582|NCT00038467|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy – Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
1298583|NCT00038467|Secondary|Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy – Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0=‘Not at all’ to 4=‘Very much’. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study included all randomized participants with available data for any given endpoint and were grouped according to randomized treatment, irrespective of whether they were actually treated or not.|||units on a scale||Standard Deviation|Mean
1298584|NCT00038467|Secondary|Number of Participants With Fracture: Bone Metabolism Sub-study||Baseline up to 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.|||participants|||Number
1298585|NCT00038467|Secondary|Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study|N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
1298586|NCT00038467|Secondary|Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study|Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
1298618|NCT00036569|Primary|Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas|Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.|8 yrs 6 mo 0 days||||Percentage of patients|||Number
1298645|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 24|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Baseline, Week 24|Treated Participants, Last Observation Carried Forward (LOCF), as-randomized population (refers to the treatment regimen assigned at randomization).|||percent change|||Number
1298588|NCT00038467|Secondary|Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
1298589|NCT00038467|Secondary|Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
1298590|NCT00038467|Secondary|Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant’s value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.|||T-score||Standard Deviation|Mean
1298591|NCT00038467|Secondary|Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.|||percent change||Standard Deviation|Mean
1298592|NCT00038467|Secondary|Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.|||percent change||Standard Deviation|Mean
1298593|NCT00038467|Secondary|Number of Events of Second Breast Cancer in Contralateral Breast: Main Study|Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.|Baseline up to Month 120|ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.|||events|||Number
1298594|NCT00038467|Secondary|Overall Survival (OS) at Month 36 Post-Randomization: Main Study|OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants’ survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.|Baseline up to Month 120|ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.|||probability of OS||95% Confidence Interval|Number
1298632|NCT00035932|Primary|Mean Change From Baseline in HIV RNA at Week 96||Baseline, Week 96|Randomized participants while on initial regimen|||log10 c/mL||Standard Error|Mean
1298813|NCT00023595|Secondary|H01: Exercise Duration|Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test|From randomization to 24 months follow-up|Only patients with exercise duration data at baseline or 24 months were analyzed.|||minutes||Standard Deviation|Mean
1298595|NCT00038467|Primary|Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study|DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.|Baseline up to Month 36|Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.|||probability of DFS||95% Confidence Interval|Number
1298596|NCT00038103|Secondary|Survival|Time from randomization to date of death (any cause).|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death|Evaluable population|||weeks||95% Confidence Interval|Median
1298597|NCT00038103|Secondary|Time to Treatment Failure|Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population|||Weeks||95% Confidence Interval|Median
1298598|NCT00038103|Secondary|Time to Tumor Progression|Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV|Evaluable population|||weeks||95% Confidence Interval|Median
1298599|NCT00038103|Secondary|Duration of Long-Term SD|Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV|Evaluable population. Number of participants analyzed = number of subjects with long-term SD.|||weeks||95% Confidence Interval|Median
1298600|NCT00038103|Secondary|Duration of Objective Response (in Subjects With CR or PR)|Time from the first objective documentation of response until the first objective documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population. Number of participants analyzed = number of subjects with objective response.|||weeks||95% Confidence Interval|Median
1298601|NCT00038103|Secondary|Duration of Clinical Benefit|Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population. Number of participants analyzed = number of subjects with clinical benefit.|||weeks||95% Confidence Interval|Median
1298602|NCT00038103|Secondary|Number of Subjects With Objective Response|Objective tumor response includes subjects with CR or PR according to RECIST.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population|||participants|||Number
1298603|NCT00038103|Primary|Number of Subjects With Clinical Benefit|Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.|Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)|Evaluable population|||participants|||Number
1298604|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 96 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 96|Number of subjects enrolled at this time point.|||Scores on scale||Standard Error|Mean
1298605|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 72 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 72|Number of subjects enrolled at this time point.|||Scores on a scale||Standard Error|Mean
1298606|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 48 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 48||||Scores on a scale||Standard Error|Mean
1298607|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24||||Scores on a scale||Standard Error|Mean
1298608|NCT00037830|Secondary|Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication|The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Least Squares Mean
1298609|NCT00037830|Secondary|Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication|The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Least Squares Mean
1298610|NCT00037830|Post-Hoc|Estimated Rate of Change in Unified Parkinson's Disease Rating Scale (UPDRS)Motor Scores Assessed Off Medication||Week 36 to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Mean
1298611|NCT00037830|Post-Hoc|Estimated Change in Points Per Week on Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score Assessed Off Medication|Unified Parkinson's Disease Rating Scale (UPDRS) A four part scale used to assess the severity of Parkinson's disease symptoms. Part I contains questions concerning the patient's mentation, behavior and mood. Part II asks questions about the patient's ability to perform activities of daily living. Part III is the motor examination of the patient's symptoms ranging in scores from 0 to 4 with 0 equaling either normal or absence of symptoms. The minimum score on this section is 0 and the maximum is 108. Part IV asks the patient questions about any complications of therapy they have experienced within the past week. However, for this study the total UPDRS included Parts I, II, and III. A higher the score on the scale indicates more severe symptoms.|Week 6 to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Mean
1298612|NCT00037830|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Scores From Baseline to Week 120 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Least Squares Mean
1298613|NCT00037830|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Least Squares Mean
1298614|NCT00036569|Secondary|Number of Participants With a Metabolic and Biological Change in the Brainstem Through Magnetic Resonance Imaging (MRI) Techniques|MRI of the brain will be performed at the NCI prior to cycles 1, 2, 3, 5, 7, and continuing every other month until cycle 27. Following cycle 27 the patient will have an MRI performed every third cycle until cycle 52 at which time they will have an MRI performed annually, and when clinically indicated. Baseline MR images are compared with MR images performed during the various cycles (e.g. cycles 1, 2, 3...) Imaging was exploratory and the degree of change that is considered clinically significant rather than technique related is still being explored.|once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.||||Participants|||Number
1298615|NCT00036569|Secondary|Mean Quality of Life (QOL) Score at Baseline and Follow-Up|QOL questionnaires will be performed prior to every cycle for patients age 6-18 years and their parents until cycle 27 and then prior to every third cycle until cycle 52 when the evaluations will become annual. The QOL (NIH Impact of Pediatric Illness Scale) is too detailed to be described and/or shown here. It is a questionnaire made up of approximately 40 questions-the answers are ranked from 1 to 5 with 5 being no impact and 1 being significant impact-For further details see the protocol.|once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.||||Units on a scale||Standard Error|Mean
1298616|NCT00036569|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|8 yrs 11 mo 22 days||||Participants|||Number
1298617|NCT00036569|Secondary|Median Time to Progression|Time between the final day of treatment to the day of disease progression.|8 yrs 11 mo 22 days||||Days|||Number
1298619|NCT00036270|Secondary|Number of Participants With New Primary Non-breast Cancers|Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.|||Participants|||Number
1298620|NCT00036270|Secondary|Number of Events for Time to Relapse|Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.|||Events (disease relapse)|||Number
1298621|NCT00036270|Secondary|Time to New Primary Breast Cancers|New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).|Baseline (Month 0) up to 5 years|Data was not analyzed due to insufficient number of events reported for the endpoint.||||||
1298622|NCT00036270|Secondary|Number of Events for Overall Survival (OS)|Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.|||Events (death)|||Number
1298623|NCT00036270|Primary|Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years|Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.|Baseline (Month 0) up to 5 years|ITT population included all participants who were randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.|||Events (disease relapse or death)|||Number
1298624|NCT00036270|Primary|Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years|Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.|Baseline (Month 0) up to 2.75 years|Intent-to-Treat (ITT) population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at 2.75 years.|||Events (disease relapse or death)|||Number
1298625|NCT00035932|Secondary|HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48|Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.|||log10 c/mL||Standard Error|Mean
1298626|NCT00035932|Secondary|HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24|Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.|Baseline, Week 24|Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).|||log10 c/mL||Standard Error|Mean
1298627|NCT00035932|Secondary|Inhibitory Quotient at Week 48|Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.|||ratio||Standard Error|Mean
1298628|NCT00035932|Secondary|Inhibitory Quotient at Week 24|Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.|Baseline, Week 24|Participants with evaluable IQ measurements (ie, must have both Cmin and IC50 measurements); as-randomized population (refers to the treatment regimen assigned at randomization).|||ratio||Standard Error|Mean
1298629|NCT00035932|Secondary|HIV IC50 at Week 24|IC50: inhibitory concentration of drug required to reduce viral replication by 50%.|Week 24|Participants with evaluable IC50 measurements; as-randomized population (refers to the treatment regimen assigned at randomization).|||ng/mL||Standard Error|Mean
1298630|NCT00035932|Secondary|Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values|"The minimum or trough concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose."|collected at the pre-dose time point after receiving atazanavir for at least four weeks|Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).|||ng/mL||Standard Error|Mean
1298631|NCT00035932|Secondary|Number of Participants Utilizing Resources for Managing Lipid Elevation|Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions.|Baseline, Week 24, Week 48|Although the intent of this planned analysis was to provide a model of economic value for Lipid Management, a different approach was taken to create this model which did not require data from this trial, and thus this analysis was not done.|||Participants|||Number
1298633|NCT00035932|Secondary|Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)|The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.|Baseline, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.|||units on a scale||Standard Error|Mean
1298634|NCT00035932|Secondary|Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)|The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.|Baseline, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.|||units on a scale||Standard Error|Mean
1298635|NCT00035932|Secondary|Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire|The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Baseline, Week 24, Week 48|Number of Participants Analyzed=treated participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=subset of treated participants (Given the language limitation, a subset of the AI424045 population was included in the MACS adherence analysis.)|||participants|||Number
1298636|NCT00035932|Secondary|PR Interval and Change From Baseline by Analysis Time Point|The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.|Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint|||msec||Standard Error|Mean
1298637|NCT00035932|Secondary|Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula.|Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint|||msec||Standard Error|Mean
1298638|NCT00035932|Secondary|Grade 3/4 Laboratory Abnormalities Through Week 48|Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4).|From Enrollment to Week 48|Evaluable treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
1298639|NCT00035932|Secondary|Fasting Glucose Mean Change From Baseline at Week 48||Week 48|Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).|||mg/dL||Standard Error|Mean
1298640|NCT00035932|Secondary|Fasting Glucose Mean Change From Baseline at Week 24||Baseline, Week 24|Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).|||mg/dL||Standard Error|Mean
1298641|NCT00035932|Secondary|Most Common AEs and AEs of Interest Through Week 48|Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.|From Enrollment to Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
1298642|NCT00035932|Secondary|Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48|AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.|From Enrollment through Week 48|Randomized participants for Deaths and SAEs; treated participants for all others; as-randomized population (refers to the treatment regimen assigned at randomization). In addition, of the 213 screen failures (not randomized), there were 4 subjects who had an SAE; these are not included in the table below.|||participants|||Number
1298643|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 96, Observed Values|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Week 96|Treated Participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||percent change in lipid values|||Number
1298644|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 48|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Week 48|Treated Participants, Last Observation Carried Forward (LOCF); as-randomized population (refers to the treatment regimen assigned at randomization).|||percent change in lipid values|||Number
1298646|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.|||Pearson Correlation Coefficient|||Number
1298647|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.|Baseline, Week 24|Participants with evaluable PK measurements, as-randomized population (refers to the treatment regimen assigned at randomization).|||Pearson Correlation Coefficient|||Number
1298648|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.|||Pearson Correlation Coefficient|||Number
1298649|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.|Baseline, Week 24|Week 24: Participants with evaluable PK measurements|||Pearson Correlation Coefficient|||Number
1298650|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline, Week 96|Randomized participants (while on initial regimen) with evaluation at time point|||cells/mm3||Standard Error|Mean
1298651|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline, Week 48|Randomized participants while on initial regimen (completers censored).|||cells/mm3||Standard Error|Mean
1298652|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Baseline, Week 24|Randomized participantsRandomized participants while on initial regimen (completers censored).|||cells/mm3||Standard Error|Mean
1298653|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 96|Randomized participants while on initial regimen (completers censored)|||participants|||Number
1298654|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 48|Randomized participantsRandomized participants while on initial regimen (completers censored).|||participants|||Number
1298655|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 24|Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
1298656|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 96|Randomized participants while on initial regimen (completers censored).|||participants|||Number
1298657|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 48|Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
1298658|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 24|Randomized participants while on initial regimen Randomized participants, (completers censored).|||participants|||Number
1298659|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96||Week 96|Randomized participants while on initial regimen (completers censored).|||Participants|||Number
1298660|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 48|As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.|||participants|||Number
1298661|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48||Week 48|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||Participants|||Number
1298662|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 24|As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.|||participants|||Number
1298663|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24||Week 24|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
1298664|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96.|Baseline, Week 96|Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement.|||participants|||Number
1298665|NCT00035932|Primary|Mean Change From Baseline in HIV RNA at Week 48||Baseline, Week 48|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||log10 c/mL||Standard Error|Mean
1298666|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 48|Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).n=number of evaluable (overall, PI sensitive, PI resistant) participants.|||participants|||Number
1298667|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 24|Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=number of evaluable (overall, PI sensitive, PI resistant) participants.|||participants|||Number
1298668|NCT00035932|Secondary|Mean Change From Baseline in HIV RNA at Week 2||Baseline, Week 2|Treated participants, as-randomized (refers to the treatment regimen assigned at randomization).|||log10 c/mL||Standard Error|Mean
1298669|NCT00035932|Primary|Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24||Baseline, Week 24|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||log10 c/mL||Standard Error|Mean
1298670|NCT00035815|Secondary|Rate of Change in ALS Functional Rating Scale.|The final secondary outcome measure was the rate of change in the ALS Functional Rating Scale (ALSFRS-r) score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). This is a scale from 0 to 48 assessing functional impairment in 12 clinically relevant areas in ALS. Forty-eight is normal with full function and zero is total loss of function in all clinical functions. As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.|Baseline and 24 months||||Units on a scale per month||Standard Deviation|Mean
1298671|NCT00035815|Secondary|Number of Participants Alive and Tracheostomy-free at 24 Months|Patients who elected to proceed to tracheostomy were assessed the month of their procedure. Subjects who continuously utilized non-invasive positive pressure ventilation for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous Non Invasive Positive Pressure Ventilation (NIPPV). All subjects were followed for the 24 month time period.|baseline to 24 months||||participants|||Number
1298672|NCT00035815|Primary|Rate of Change in Composite Manual Muscle Testing (MMT) Score|The primary outcome measure was the rate of change in the MMT score. MMT involved the examination of 34 muscle groups with standard positioning. The final MMT score represented an average of the 34 muscles examined, and ranged from 10 to 0(10 normal strength, 0 paralyzed). The individual muscle score was based on the medical research council (MRC) grading scale (1-5) modified to a 10 point system corresponding to the MRC modifications of plus and minus (5, 5-,4+,4,4-,3+,3, 3-,2,1,0; with 5 being normal strength and 0 paralyzed).|Baseline and 24 months||||MMT units per month||Standard Deviation|Mean
1298673|NCT00035555|Other Pre-specified|Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results|Normal laboratory values: Hemoglobin (g/dL): Males (18-64 years) 13.8-17, (65 years and older) 11.8-16.8; Females (18-64 years) 12.0-15.6, F (65 years and older) 11.1-15.5. Platelets (per mm^3) 130,000-400,000. Leukocytes (18 years and older) 3.8-10.8 1000/uL. ALT (u/L)(13 years and older) 0-48.|Days 8 and Months 1, 3, 6, 9, and 12 posttransplant (from Day 1)|All randomized participants who underwent transplantation and who received treatment|||Participants|||Number
1298674|NCT00035555|Secondary|Number of Participants With Posttransplant Diabetes Mellitus|Posttransplant diabetes mellitus is defined as the need for treatment of hyperglycemia with either an oral agent or insulin for a total of >4 weeks or hemoglobin A1c (HbA1c) >7% in a participant not known to be diabetic prior to transplantation|By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )|All randomized participants who received transplants and who were not known to be diabetic prior to transplant|||Participants|||Number
1298675|NCT00035555|Secondary|Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels|LDL=low-density lipoprotein; HDL=high-density lipoprotein. Total cholesterol=LDL + HDL + very low-density (VLDL) cholesterol. VLDL=triglycerides divided by 5. Non-HDL cholesterol=Total cholesterol minus HDL cholesterol.|By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)|All randomized participants who received a transplant; n=evaluable participants.|||mg/dL||Standard Deviation|Mean
1298691|NCT00032591|Secondary|DASS at 2 Years of Follow-up|Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction.|At two years of follow-up|Randomized participants with at least one day of follow-up, per intent to treat|||score||Standard Deviation|Mean
1298814|NCT00023595|Secondary|H02: 6 Minute Walk Distance||From randomization to 24 month follow-up|Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.|||meters||Standard Deviation|Mean
1298676|NCT00035555|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 (posttransplant) continuously to 56 days following last dose of study medication|All randomized participants who underwent transplantation and who received treatment|||Participants|||Number
1298677|NCT00035555|Secondary|Number of Participants With Hypertension|Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg or, the use of any antihypertensive medication.|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation|||Participants|||Number
1298678|NCT00035555|Secondary|Percentage of Participants Who Used Antihypertensive Medication|Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation|||Percentage of participants|||Number
1298679|NCT00035555|Secondary|Mean Iohexol Clearance|Iohexol, a true glomerular filtration marker, is used to measure glomerular filtration rate.|By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)|All randomized participants who underwent transplantation|||mL/min per 1.73 m^2||Standard Deviation|Mean
1298680|NCT00035555|Secondary|Percentage of Participants Who Had Chronic Allograft Nephropathy|Based on postbaseline biopsies|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation and who had at least 1 biopsy following Day 1; n=evaluable participants|||Percentage of participants|||Number
1298681|NCT00035555|Secondary|Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)|Throughout this study, acute rejection=clinically-suspected and biopsy-proven acute rejection (BPAR). Clinically-suspected rejection is defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function. BPAR includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. PAR is defined as an elevation in SCr ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function that led the investigator to suspect that the participant had experienced acute rejection, and in whom either the biopsy did not confirm acute rejection and the participant received treatment for acute rejection or the participant received treatment for acute rejection without a biopsy to confirm the diagnosis.|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation|||Percentage of participants|||Number
1298682|NCT00035555|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection|BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. A participant was reported as having had an episode of treated acute rejection if he or she received antirejection therapy during an episode of rejection (clinically-suspected or biopsy-proven rejection).|By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)|All randomized participants who underwent transplantation|||Percentage of participants|||Number
1298683|NCT00035555|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12|BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed.|Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation|||Percentage of participants|||Number
1298684|NCT00035555|Primary|Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)|No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.|By Month 6 posttransplant (From Day 1 to Month 6)|All randomized participants who underwent transplantation|||Participants|||Number
1298685|NCT00033917|Secondary|Language Outcome|"Peabody Picture Vocabulary Test (PPVT) This is a semantic language test. The mean value is 100; standard deviation is 16 points. A higher score means better language; a lower score means poorer language.~There are no subscales to the PPVT. The measurement unit is points on a scale. A score < 70 indicates severely abnormal language function."|at 8 years|Three hundred twenty eight subjects were available at age 8 years. They were tested with the PPVT.|||participants with PPVT score < 70|||Number
1298686|NCT00033917|Primary|IVH at 5 Postnatal Days|Cranial ultrasounds were performed daily for the first 5 postnatal days; the main outcome measure was intraaventricular hemorrhage (IVH) at 5 days of age|at 5 days|All subjects had negative cranial ultrasounds with no evidence for IVH at 6 - 12 postnatal hours|||IVH|||Number
1298687|NCT00032630|Primary|Long-term Composite|Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year.|one-year||||Participants|||Number
1298688|NCT00032630|Primary|Short-term End Point|Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.|30 day||||participants|||Number
1298689|NCT00032591|Secondary|Health Care Costs at 2 Year||After 2 years of follow-up for each subject|Randomized participants with at least one day of follow-up, per intent to treat|||U.S. Dollars||Standard Deviation|Mean
1298690|NCT00032591|Secondary|Cumulative Gain in Health Utilities at 2 Year|Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health. Since the time frame is 2 years, the range is -0.72 to 2.00.|After 2 years of follow-up for each subject|Randomized participants with at least one day of follow-up, per intent to treat|||score||Standard Deviation|Mean
1298693|NCT00032591|Primary|Time to First Event (Death, Stroke, Major Bleed)|"Time to first event (death, stroke, major bleed)~The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information."|Time to event|Randomized participants with at least one day of follow-up, per intent to treat|||cumulative probability of event||95% Confidence Interval|Number
1298694|NCT00032487|Secondary|Secondary Endpoint|New or worsening angina, new transient ischemic attack (TIA), new intermittent claudication or critical limb ischemia with Doppler evidence or total mortality.|Post baseline time to first event up to 82 months||||participants|||Number
1298695|NCT00032487|Primary|Primary Major Macrovascular Events|Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene.|Post baseline time to the first major macrovascular event up to 82 months||||participants|||Number
1298696|NCT00031551|Other Pre-specified|Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy|Participants selected from 14 word descriptors of sensory (S) pain and 11 word descriptors of affective (A) pain.|day 9 (+/- 24 hours) after conditioning chemotherapy|One subject was in critical condition at day 9 after CT, preventing data collection at this time|||percentage of participants|||Number
1298697|NCT00031551|Other Pre-specified|Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)|Subjects rated pain using the Painometer, a hand-held tool with a visual analogue scale to rate overall pain intensity and a list of 14 sensory and 11 affective pain descriptors ranked by intensity values from 1 - 5. Subjects look at the list of sensory and affective words and select words that describe their pain, including Oral Pain and Oral Pain with Swallowing. . The weighted scores assigned to the words are added to obtain a pain intensity score for the sensory and the affective components. The overall pain intensity is measured on a visual analogue scale which has a range of 1 - 10 with high scores indicating higher pain intensity. The sensory and affective pain scores are otained by adding all of the respective intensity values. The range of possible sensory scores is from 0 - 48 and the range of possible affective scores is from 0 - 37. The sensory and affective scores may be added together to obtain the total pain intensity score, which may range from 0 - 85.|Day 9 (+/- 24 hours) after conditioning chemotherapy|One subject was in critical condition at day 9 after CT, preventing data collection at this time|||units on a scale||Standard Deviation|Mean
1298698|NCT00031551|Secondary|What is the Toxicity of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment -Related Stomatitis?|Toxicity will be measured by the incidence of adverse events.|2 years||||event|||Number
1298699|NCT00031551|Primary|What is the Clinical Efficacy of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment-related Stomatitis?|Clinical efficacy will be determined by measurement of stomatitis grade and oropharyngeal pain.|2 years|Participants withdrew and analyses were terminated before any data collected.||||||
1298700|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Glasgow Coma Scale (GCS).|The assessment scoring for the Glasgow Coma Scale is as follows: 15: no neuropsychological impairment; 12 - 14: mild neuropsychological impairment; 9 - 11: moderate neuropsychological impairment; 6 to 8: severe neuropsychological impairment; and <6: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.|||Participants|||Number
1298701|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days, and at 6 and 12 Months, as Measured by the Mini-Mental Status Examination (MMSE).|The assessment score for the Mini-Mental Status Examination is as follows: 27 - 30: no neuropsychological impairment; 23 - 26: mild neuropsychological impairment; 16 - 22: moderate neuropsychological impairment; 11 - 15 severe neuropsychological impairment; and <=10: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.|||Participants|||Number
1298702|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Mattis Dementia Rating Scale (MDRS)|The assessment scoring for the Mattis Dementia Rating Scale is as follows: 139 - 144: no neuropsychological impairment; 121- 138: mild neuropsychological impairment; 114 - 120: moderate neuropsychological impairment; 87 - 113: severe neuropsychological impairment; and <=86: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.|||Participants|||Number
1298703|NCT00031486|Secondary|Median Number of Reported AEs Describing Safety and Tolerance of Valacyclovir (VACV), Evaluated by the Number Adverse Events, Administered at a Dose of 2.0 Grams Given Orally 3 Times a Day for 90 Days.|The measure is the number of adverse events per subject. Adverse events were recorded from time of first dose of study drug through 6 months post start of study drug.|6 months||||Events per participants||Full Range|Median
1298704|NCT00031486|Secondary|Effect of Antiviral Therapy on Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) in Cerebral Spinal Fluid (CSF)|Few CSF specimens were collected on day 90, hence unable to calculate the difference in PCR at day 0 and day 90.[measured quantitatively by polymerase chain reaction (PCR)].|Day 0 and Day 90.|The number of participants analyzed is 0 because there specimens obtained were inadequate and insufficient to analyze.|||viral load|||Number
1298705|NCT00031486|Secondary|Effect of Study Medication on Quality of Life Measurements.|The SF-36 Questionnaire measures quality of life as reported by the subject. The questionnaire contains 36 questions, each questions can be assigned a maximum score of 100. For each subject, a perfect score would be 3600, hence the higher score is best. The calculated scores reported in the table below reflect the diffence between Day 0 (day study drug started) and Day 90, Day 0 (day study drug started) and Month 6, and Day 0 (day study drug started) and Month 12.|Day 0 and 90, Day 0 and Month 6 and Day 0 and Month 12|All subjects that were assessed at baseline and the following time points: 90 days, 6 and 12 months.|||Scores on a scale Change in SF-36||Full Range|Median
1298706|NCT00031486|Primary|Survival With no or Mild Neuropsychological Impairment at 12 Months After Initiation of Study Medication as Measured by the Mattis Dementia Rating Scale (MDRS)|Number of subjects who were assessed to have no or mild neuropsychological impairment at 12 months using the Mattis Dementia Rating Scale. (A score of 121 or higher refects no or mild neuropsychological impairment.) Scale is: 139-144 normal; 121-139 mild; 114-120 moderate; 87-113 severe; and <=86 very severe.|One year post therapy.|All subjects that survived to 12 months and were assessed.|||Participants|||Number
1298707|NCT00031460|Primary|Participants With Neurologic Impairment at 12 Months as Measured by Bayley's Neuro-developmental Assessment.(Mental Scores)|Mental scores of all subjects completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.|At 12 months of life.||||participants|||Number
1298708|NCT00031460|Secondary|Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by PCR at Anytime During the Initial 12 Months of Life.|Number of participants assessed to have a positive herpes simplex virus (HSV) DNA by polymerase chain reaction (PCR) in the cerebrospinal fluid (CSF) at any time during their initial 12 months of life after treatment. The PCR is a technique to help visualize copies of a piece of DNA.|post randomization - 12 months||||participants|||Number
1298709|NCT00031460|Secondary|Number of Participants With Two or Fewer Episodes of Cutaneous Recurrence of Herpes Simplex Virus (HSV) Disease Post-randomization During the Initial 12 Months of Life.|Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.|post randomization - 12 months||||participants|||Number
1298710|NCT00031460|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment (Motor Scores).|Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.|At 12 months of life.||||participants|||Number
1298711|NCT00031447|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)|Mental scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: less than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|Two of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment(mental); therefore, 2 placebo subject and 6 acyclovir subjects are included in the analysis.|||Participants|||Number
1298712|NCT00031447|Secondary|Two or Fewer Episodes of Cutaneous Recurrence of HSV Disease Post-randomization During the Initial 12 Months of Life.|Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.|post randomization - 12 months||||participants|||Number
1298713|NCT00031447|Secondary|Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by Polymerase Chain Reaction (PCR) at Anytime During the Initial 12 Months of Life.|Number of participants with positive herpes simplex virus (HSV) DNA by polymerase cahin reaction (PCR) in the cerebrospinal fluid of subjects assessed during the initial 12 months of life.|post randomization at 12 months||||Participants|||Number
1298714|NCT00031447|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment.(Motor Scores)|Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|Three of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment (motor score); therefore, 1 placebo subject and 6 acyclovir subjects are included in the analysis.|||Participants|||Number
1298715|NCT00030992|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|10 years||||Participants|||Number
1298716|NCT00030992|Primary|Response Rate|Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|6 weeks||||Percentage of participants|||Number
1298717|NCT00030147|Primary|Center for Epidemiologic Studies–Depression Scale (CES-D)|Center for Epidemiologic Studies–Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.|Week 8|The analyses included those subjects who completed eight weeks of study|||Units on a scale||Standard Deviation|Mean
1298734|NCT00029146|Secondary|Disabling Stroke|2 yr Kaplan-Meier estimates of the proportions. Disabling stroke is defined as a modified Barthel Index of <12/20 at the first scheduled return visit more than 3 months after the stroke occurred|within two years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
1298718|NCT00030147|Primary|Center for Epidemiologic Studies–Depression Scale (CES-D)|Center for Epidemiologic Studies–Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.|Baseline|The analyses included those subjects who started the study.|||Units on a scale||Standard Deviation|Mean
1298719|NCT00029536|Secondary|Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.||9 years||||mcg/mL||Standard Deviation|Mean
1298720|NCT00029536|Secondary|Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.|Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.|9 years||||ng/ml||Inter-Quartile Range|Median
1298721|NCT00029536|Secondary|Percentage of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency for Secondary Generalized, Complex Partial and Simple Partial Seizures Considered Separately|Percentage of women who show a greater than 50% decline in average daily seizure frequency for secondary generalized, complex partial and simple partial seizures considered separately|9 years||||percentage of participants|||Number
1298722|NCT00029536|Secondary|Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.|Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.|9 years||||percentage of participants|||Number
1298723|NCT00029536|Primary|Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency|Percent of women who show a greater than 50% decline in average daily seizure frequency|9 years||||percentage of participants|||Number
1298724|NCT00029172|Primary|Twelve Week Depression Outcomes|"Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%.~The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale."|Twelve week||||HAM-D depression score||Standard Deviation|Mean
1298725|NCT00029146|Other Pre-specified|Any Stroke or Death Within 30 Days After Surgery||within 30 days after surgery|Intention-to-treat. All assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy|||participants|||Number
1298726|NCT00029146|Secondary|Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization|2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 years of randomization|On-treatment analysis removing four participants assigned to the surgical group who never underwent surgery and censoring on the day of surgery three participants assigned to the nonsurgical group who underwent EC-IC bypass surgery.|||percentage of participants||95% Confidence Interval|Number
1298727|NCT00029146|Secondary|Summary SS-QOL Score|Summary Stroke Specific Quality of Life score (1-4) askes how self-reported overall quality of life compares with with that before stroke. A higher score indicates is better.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||units on a scale||95% Confidence Interval|Mean
1298728|NCT00029146|Secondary|Modified Barthel Index 19-20|Modified Barthel Index dichotomized 19-20 vs <= 18. The modifed Barthel Index(0-20) describes the degree of independence in day-to-day self-care activities. A higher score indicates greater independence.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants|||Number
1298729|NCT00029146|Secondary|Modified Rankin 0-2|Proportion with Modified Rankin score at 2 yrs, dichotomized 0-2 vs 3-6. The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
1298730|NCT00029146|Secondary|Modified Rankin 0-1|Proportion with modified Rankin score, dichotomized 0 or 1 vs 2-6.The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
1298731|NCT00029146|Post-Hoc|Any Stroke or Death|2 yr Kaplan-Meier estimates of the proportions. Any stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
1298732|NCT00029146|Secondary|Death|2 yr Kaplan-Meier estimates of the proportions. Death of any cause|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
1298733|NCT00029146|Secondary|Fatal Stroke|2 yr Kaplan-Meier estimates of the proportions. Fatal stroke is a stroke that in the investigator’s opinion led directly to the participants death within 30 days of occurrence|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
1298815|NCT00023595|Secondary|H01: 6 Minute Walk Distance||From randomization to 24 month follow-up|Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.|||meters||Standard Deviation|Mean
1298735|NCT00029146|Secondary|All Stroke|2 yr Kaplan-Meier estimates of the proportions. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours|within 2 yrs of randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
1298736|NCT00029146|Primary|Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization|2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 yrs of randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
1298737|NCT00029107|Primary|Percent of Patients in Remission|The primary endpoint was the difference in rate of remission between the 2 arms at 6 months from study entry.|month 6||||percent of participants||95% Confidence Interval|Number
1298738|NCT00028262|Primary|Change in Cellular Granular Osmiophilic Deposits (GRODs) in Electron Micrographs of Peripheral White Blood Cells.|The GRODs in peripheral white blood cells from all patients before and during treatment were analyzed by transmission electron microscopy (TEM) at 30000xmagnification. Two investigators working independently of each other identified and counted the GRODs and the results were averaged.|10 years|Out of 10 enrolled subjects, one subject did not complete study and was lost to follow up.|||Average number of GRODs||95% Confidence Interval|Mean
1298739|NCT00028093|Primary|Change in Hepatitis C Virus RNA Levels During Phase I||From day 0 to day 3||||log(IU/mL)||Full Range|Median
1298740|NCT00027378|Primary|Depressive Symptoms|Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10, 12. The BDI is a subject reported measure that has a minimum score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scale (63).|Average score as measured by participant's report on the Beck Depression Inventory (BDI).||||units on a scale||Standard Deviation|Mean
1298741|NCT00027378|Primary|Alcohol Use Behaviors|Alcohol use behaviors measured by drinks per week.|Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.|Participants were randomized to either fluoxetine-treated or placebo.|||standard drink (14 gr. alcohol)||Standard Deviation|Mean
1298742|NCT00027027|Secondary|Pharmacokinetic Measurement of Terminal Half-Life (t1/2 Terminal) in Days|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants|||days||Standard Deviation|Mean
1298743|NCT00027027|Secondary|Pharmacokinetic Measurement of Initial Distribution Half-Life (t1/2 Initial)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|Only participants in the measured treatment groups where a two-compartment model was used are included in the analysis.|||days||Standard Deviation|Mean
1298744|NCT00027027|Secondary|Pharmacokinetic Measurement of Steady-State Volume of Distribution (Vss)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|Only participants in the measured treatment groups where a two-compartment model was used are included in the analysis.|||mL/kg||Standard Deviation|Mean
1298745|NCT00027027|Secondary|Pharmacokinetic Measurement of Volume of Central Compartment (Vc)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants|||mL/kg||Standard Deviation|Mean
1298746|NCT00027027|Secondary|Pharmacokinetic Measurement of Systemic Clearance (CL)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants|||mL/day/kg||Standard Deviation|Mean
1298747|NCT00027027|Secondary|Pharmacokinetic Measurement of Area Under the Curve (AUC)|Mean rhuMAb 2C4 serum concentrations versus nominal time profiles for the first two treatment cycles are presented for AUC micrograms per milliliters (ug/mL) by day. A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes following start of infusion and at 1.5, 4, and 8 hours postdose) 2, 5, 8 and 15 of Cycle 1; Days 1 (predose and 29 minutes following start of infusion) and 8 of Cycle 2|All enrolled participants|||ug*hr/mL||Standard Deviation|Mean
1298777|NCT00023595|Secondary|H01: KCCQ Social Limitation|"These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298748|NCT00027027|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|"Incidence of DLTs defined as any Grade 3 or 4 major organ toxicity according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2 or any subjectively intolerable toxicity felt by the investigator to be related to rhuMAb 2C4.~One participant in the 15.0 mg/kg dose group experienced a gastrointestinal hemorrhage on Day 16. This event was judged by the investigator to be related to study drug. The participant recovered in 3 days and continued to receive rhuMAb 2C4 beyond Cycle 2.This was the only DLT reported during the first two treatment cycles."|Day 1 of Cycles 1 and 2, and 24 hours after Cycle 2 infusion|All enrolled participants who completed at least 2 cycles of study treatment.|||participants|||Number
1298749|NCT00027027|Primary|Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death|"For this protocol, an AE is defined any untoward medical occurrence (e.g., sign, symptom, disease, syndrome, intercurrent illness, abnormal laboratory finding) that emerges or worsens relative to pretreatment baseline during the treatment or post-treatment periods, regardless of the suspected cause.~For this protocol an SAE was defined as any AE that occurred at any dose if:~It resulted in death (i.e., the AE caused or led to death),~It was life threatening,~It required or prolonged inpatient hospitalization,~It was disabling,~It resulted in a congenital anomaly/birth defect,~It may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above.~The primary cause of death for all reported cases was disease progression, and all of the deaths occurred following study discontinuation, with one death occurring within 4 weeks of the last treatment day."|Days 1, 2, 5, 8, and 15 of Cycle 1; Days 1, 8, and Week 3, of Cycles 2 and beyond up to 1 year and at the follow-up visit (4 weeks after last infusion)|All enrolled participants|||participants|||Number
1298750|NCT00025883|Primary|Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin||Baseline, 6 months, 12 months||||mg/dL||Inter-Quartile Range|Geometric Mean
1298751|NCT00025883|Primary|Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin|Percentage of glycosylated hemoglobin at Baseline, 6 months, and 12 months on treatment with metreleptin|Baseline, 6 months, 12 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
1298752|NCT00023595|Secondary|H02: Cost of Care|Hospital costs and physician fees for US patients|index hospital admission|US patients with hospital bills|||2008 US Dollars||Standard Deviation|Mean
1298753|NCT00023595|Secondary|H01: Cost of Care|Hospital costs and physician fees for US patients|index hospital admission|US patients with hospital bills|||2009 US Dollars||Standard Deviation|Mean
1298754|NCT00023595|Secondary|H02: General Health Rating Scale|This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298755|NCT00023595|Secondary|H01: General Health Rating Scale|This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298756|NCT00023595|Secondary|H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale|"These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298757|NCT00023595|Secondary|H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale|"These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298758|NCT00023595|Secondary|H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale|"These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298759|NCT00023595|Secondary|H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale|"These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298760|NCT00023595|Secondary|H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale|"These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||percentage of participants|||Number
1298761|NCT00023595|Secondary|H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale|"These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||percentage of participants|||Number
1298778|NCT00023595|Secondary|H02: KCCQ Quality-of-Life Scale|These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298762|NCT00023595|Secondary|H02: EQ-5D Health Status Index Score|"This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298763|NCT00023595|Secondary|H01: EQ-5D Health Status Index Score|"This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298764|NCT00023595|Secondary|H02: EQ-5D Visual Analog Scale|This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298765|NCT00023595|Secondary|H01: EQ-5D Visual Analog Scale|Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298766|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale|These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298767|NCT00023595|Secondary|H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale|These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298768|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale|"This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298769|NCT00023595|Secondary|H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale|"This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298770|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale|"These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298771|NCT00023595|Secondary|H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale|"These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298772|NCT00023595|Secondary|H02: KCCQ Overall Summary Score|This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298773|NCT00023595|Secondary|H01: KCCQ Overall Summary Score|This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298774|NCT00023595|Secondary|H02: KCCQ Clinical Summary Score|This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298775|NCT00023595|Secondary|H01: KCCQ Clinical Summary Score|This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298776|NCT00023595|Secondary|H02: KCCQ Social Limitation|"These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298804|NCT00023595|Secondary|H02: B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up|From randomization to 24 months follow-up|Only patients with BNP data at baseline or 4 months were analyzed.|||pg/mL||Standard Deviation|Mean
1298779|NCT00023595|Secondary|H01: KCCQ Quality-of-Life Scale|These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298780|NCT00023595|Secondary|H02: KCCQ Total Symptoms|This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298781|NCT00023595|Secondary|H01: KCCQ Total Symptoms|This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298782|NCT00023595|Secondary|H02: KCCQ Symptom Burden|"These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298783|NCT00023595|Secondary|H01: KCCQ Symptom Burden|"These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298784|NCT00023595|Secondary|H02: KCCQ Symptom Frequency|"These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298785|NCT00023595|Secondary|H01: KCCQ Symptom Frequency|"These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298786|NCT00023595|Secondary|H02: KCCQ Symptom Stability|"This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298787|NCT00023595|Secondary|H01: KCCQ Symptom Stability|"This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298788|NCT00023595|Secondary|H02: KCCQ Physical Limitation Scale|"These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298789|NCT00023595|Secondary|H01: KCCQ Physical Limitation Scale|"Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298790|NCT00023595|Secondary|H02: SF-12 Mental Component Summary (MCS) Scale|Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using “mental” regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the “mental” constant from the scoring table to the sum of the 35 products.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298791|NCT00023595|Secondary|H01: SF-12 Mental Component Summary (MCS) Scale|Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using “mental” regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the “mental” constant from the scoring table to the sum of the 35 products.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298805|NCT00023595|Secondary|H01: B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up|From randomization to 24 months follow-up|Only patients with BNP data at baseline or 4 months were analyzed.|||pg/mL||Standard Deviation|Mean
1298792|NCT00023595|Secondary|H02: SF-12 Physical Component Summary (PCS) Scale|Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using “physical” regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the “physical” constant from the scoring table to the sum of the 35 products.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298793|NCT00023595|Secondary|H01:SF-12 Physical Component Summary (PCS) Scale|Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using “physical” regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the “physical” constant from the scoring table to the sum of the 35 products.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298794|NCT00023595|Secondary|H02: SF-36 Vitality Subscale|"These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298795|NCT00023595|Secondary|H01:SF-36 Vitality Subscale|"These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298796|NCT00023595|Secondary|H02: SF-36 Social Functioning Subscale|"These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298797|NCT00023595|Secondary|H01:SF-36 Social Functioning Subscale|"These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298798|NCT00023595|Secondary|H02: SF-36 Role Emotional Subscale|"These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298799|NCT00023595|Secondary|H01:SF-36 Role Emotional Subscale|"These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298800|NCT00023595|Secondary|H02: SF-36 Role Physical Subscale|"These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298801|NCT00023595|Secondary|H01:SF-36 Role Physical Subscale|"These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298802|NCT00023595|Secondary|H02: SF-36 Mental Health Subscale|"These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1298803|NCT00023595|Secondary|H01: SF-36 Mental Health Subscale|"Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
1298819|NCT00023595|Secondary|H01: All-cause Mortality, Heart Transplant or LVAD|LVAD=Left Ventricular Assist Device|10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298820|NCT00023595|Secondary|H02: All-cause Mortality, Heart Transplant or LVAD||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298821|NCT00023595|Secondary|H01: All-cause Mortality, Heart Transplant or LVAD|LVAD=Left Ventricular Assist Device|5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298822|NCT00023595|Secondary|H01: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298823|NCT00023595|Secondary|H02: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298824|NCT00023595|Secondary|H01: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298825|NCT00023595|Secondary|H02: Stroke||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298826|NCT00023595|Secondary|H01: Stroke||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298827|NCT00023595|Secondary|H01: Stroke||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298828|NCT00023595|Secondary|H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298829|NCT00023595|Secondary|H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298830|NCT00023595|Secondary|H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298831|NCT00023595|Secondary|H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298832|NCT00023595|Secondary|H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298833|NCT00023595|Secondary|H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298834|NCT00023595|Secondary|H01: Cardiac Procedure: Heart Transplant||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298835|NCT00023595|Secondary|H02: Cardiac Procedure: Heart Transplant||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298836|NCT00023595|Secondary|H01: Cardiac Procedure: Heart Transplant||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298837|NCT00023595|Secondary|H01: Heart Failure Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298838|NCT00023595|Secondary|H02: Heart Failure Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298839|NCT00023595|Secondary|H01: Heart Failure Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298840|NCT00023595|Secondary|H01: All-cause Mortality or Heart-failure Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298841|NCT00023595|Secondary|H02: All-cause Mortality or Heart-failure Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298843|NCT00023595|Secondary|H02: All-cause Mortality Within 30 Days After Randomization||30 days post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm|||participants|||Number
1298844|NCT00023595|Secondary|H01: All-cause Mortality Within 30 Days After Randomization||30 days post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298845|NCT00023595|Secondary|H02: All-cause Mortality||up to 5 years|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298846|NCT00023595|Secondary|H01: Mortality or Cardiovascular Hospitalization||up to 10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298847|NCT00023595|Secondary|H01: Mortality or Cardiovascular Hospitalization||up to 5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298848|NCT00023595|Secondary|H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298849|NCT00023595|Secondary|H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298850|NCT00023595|Primary|H02: All-cause Mortality or Cardiovascular Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298851|NCT00023595|Primary|H01: All Cause Mortality||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298852|NCT00023595|Primary|H01: All Cause Mortality||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
1298853|NCT00023452|Secondary|Cumulative Rate of Participants <12 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants <12 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|||||||
1298854|NCT00023452|Secondary|Cumulative Rate of Participants <18 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants <18 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|||||||
1298855|NCT00023452|Secondary|Cumulative Rate of HIV-Infected Participants With Culture-Confirmed or Probable TB Disease at 24 Months After Completion of Study Therapy|Cumulative TB disease rate was defined as number of HIV-infected participants with culture-confirmed TB (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)|||||||
1298856|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed or Probable TB Disease in HIV-Infected Participants Within 33 Months After Enrollment|Cumulative TB disease rate was defined as number of HIV-infected participants ≥2 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline to Month 33|||||||
1298957|NCT00006305|Secondary|Number of Participants With Death, Myocardial Infarction, or Stroke||five years|Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)|||participants|||Number
1298857|NCT00023452|Secondary|Percentage of Participants With Resistance to Study Medications in Isolates of MTB From Participants Who Developed Active TB Disease Within 33 Months of Enrollment|Drug-susceptibility testing (DST) was performed on isolates of MTB obtained from participants who developed signs and symptoms of active TB disease (including sputum specimens or specimens from appropriate body site for extrapulmonary TB disease). DST was performed at site's local laboratory and sent to Sponsor for confirmatory susceptibility testing. DST included all drugs currently used to treat TB disease, including pyrazinamide (PZA) and fluoroquinolones. Susceptibility was tested for other drugs at the Sponsor laboratory at the following concentrations: INH, 0.02, 1.0, and 5.0 micrograms per milliliter (µg/mL) and rifampin (RIF), 1.0 µg/mL. Isolates resistant to RIF were assumed to be resistant to RPT.|Baseline up to Month 33|N equals the number of participants who developed active TB disease during the study for which DST was performed.|||percentage of participants|||Number
1298858|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 33 months after enrollment (for those who completed therapy within 33 months) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|Per Protocol Population: all enrolled and eligible participants (MITT Population) who completed study drug within targeted time period (11-12 3RPT/INH doses within 10-16 weeks; 240-270 INH doses within 35-52 weeks) or developed TB disease or died while on study therapy (or follow-up) but completed ≥75% of expected number of doses prior to event.|||TB cases per 100 participants w/followup|||Number
1298859|NCT00023452|Secondary|Percentage of Participants Who Completed the Treatment Regimen|Completion in the 3RPT/INH arm was defined as: received 12 doses of RPT/INH within 16 weeks (12 weeks optimal). However, participants were considered to have completed therapy if at least 11 doses of RPT/INH had been received (~90%) during the 16-week time period. Completion in the 9INH arm was defined as: received 270 doses of INH within 52 weeks (39 weeks optimal). However, participants were considered to have completed therapy if at least 240 doses of INH were received (~90%) during the 52-week period.|Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)|MITT Population|||percentage of participants|||Number
1298860|NCT00023452|Secondary|Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH|Drug discontinuations for any reason associated with 3RPT/INH or 9INH included all reasons for discontinuation from study treatment, regardless of relationship to treatment.|Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)|MITT Population|||percentage of participants|||Number
1298861|NCT00023452|Secondary|Percentage of Participants With Methadone Withdrawal Associated With 3RPT/INH and 9INH Among Participants Receiving Concomitant Methadone|Among participants concomitantly receiving methadone, the development of methadone withdrawal (defined as having >3 new symptoms for >7 days: nausea and vomiting, abdominal cramps, body aches, restlessness, irritability, dilated pupils, tremors, involuntary twitching, lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose flesh, or diarrhea).|Baseline to Month 33|||||||
1298862|NCT00023452|Secondary|Percentage of Participants With Death Due to Any Cause||Baseline up to Month 35|Safety Population|||percentage of participants|||Number
1298863|NCT00023452|Secondary|Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH|Drug toxicities (or AEs) were graded using Common Toxicity Criteria (CTC version 2.0, Publish Date April 30, 1999, Cancer Therapy Evaluation Program). Grade 3 and 4 drug toxicities associated with 3RPT/INH or 9INH were defined as treatment-related Grade 3 or 4 AEs (considered either possibly, probably, or definitely related to the study drug by the investigator).|Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])|Safety Population|||percentage of participants|||Number
1298864|NCT00023452|Secondary|Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH|Discontinuation of study drug due to an adverse drug reaction associated with either 3RPT/INH or 9INH was defined as discontinuing treatment and/or study due to a treatment-related adverse event (AE) (considered either possibly, probably, or definitely related to the study drug by the investigator).|Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])|Safety Population: all participants who enrolled in the study and took at least 1 dose of study drug.|||percentage of participants|||Number
1298865|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment|Cumulative TB disease rate was defined as number of participants (regardless of age) with culture-confirmed TB disease (defined as positive culture for MTB]) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB, or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to 33 Months||||TB cases per 100 participants w/followup|||Number
1298880|NCT00022763|Secondary|AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)|The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||Ratio||Standard Deviation|Mean
1299037|NCT00001959|Secondary|Proteinuria After Treatment||12 months from baseline||||g/d||Inter-Quartile Range|Median
1298866|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy|Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)|MITT Population|||TB cases per 100 participants w/followup|||Number
1298867|NCT00023452|Primary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment|Cumulative TB disease rate defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for Mycobacterium tuberculosis [MTB]) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, computed tomography [CT] scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for acid-fast bacilli [AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants with (w/)33 months of follow-up calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|Modified Intention-to-Treat (MITT) Population: all participants who enrolled in study and were eligible (Ineligible=source TB case resistant to INH or rifampin; source TB case culture-negative for MTB; positive TST not confirmed; MTB drug susceptibility test results not available for source TB case; or TB disease at enrollment).|||TB cases per 100 participants w/followup|||Number
1298868|NCT00023322|Secondary|Histological Response at 5 Years|Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.|5 years||||participants|||Number
1298869|NCT00023322|Primary|Histological Response at 3 Years|Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.|3 years|Intention to treat|||participants|||Number
1298870|NCT00023309|Secondary|Histological Response|A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.|week 196 from randomization|Analysis was intention to treat. Patients with missing values at timeframe of interest was taken as random missing. No imputation was applied.|||participants|||Number
1298871|NCT00023309|Secondary|Biological Response|A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L).|week 196 from randomization|Intention to treat|||participants|||Number
1298872|NCT00023309|Secondary|Virological Response|A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL).|Week 196 from randomization|Intention to treat|||participants|||Number
1298873|NCT00023309|Secondary|HBeAg Loss at Week 196|Loss of hepatitis B surface antigen (HBsAg) at week 196|Week 196 from randomization|Analysis was intention to treat. Patients with missing values at timeframe of interest was taken as random missing. No imputation was applied.|||participants|||Number
1298874|NCT00023309|Primary|Maintained Combined Response (Virological, Biochemical and Histological Response).|A maintained combined response was defined as a combination of a virological, biochemical and histological responses at weeks 48 and 192. A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL). A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L). A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.|196 weeks from randomization|The analysis was intention to treat. Patients with missing values at week 196 were treated as random missing. No imputation was applied.|||participants|||Number
1298875|NCT00022763|Secondary|Number of Participants With Worst Local Injection Site Reactions|Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded.|Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
1298876|NCT00022763|Secondary|Number of Participants Who Prematurely Withdrew Due to AE||Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
1298877|NCT00022763|Secondary|Number of Participants Who Died||Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
1298878|NCT00022763|Secondary|Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities|Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively.|Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
1298879|NCT00022763|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to Week 4 after discontinuation of therapy|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
1298881|NCT00022763|Secondary|Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)|Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||mcg/mL||Standard Deviation|Mean
1298882|NCT00022763|Secondary|Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide|Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||hour||Standard Deviation|Mean
1298883|NCT00022763|Secondary|Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||mcg/mL||Standard Deviation|Mean
1298884|NCT00022763|Primary|Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)|The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||microgram hour per milliliter (mcg.h/mL)||Standard Deviation|Mean
1298885|NCT00016718|Primary|Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16|Proportion was calculated as number of participants with HIV-1 RNA <= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|At week 16|All Participant who enrolled in the study and with available HIV-RNA at week 16|||proportion of participants||95% Confidence Interval|Number
1298886|NCT00016718|Primary|Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16|Proportion was calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|At week 16|All Participant who enrolled in the study and with available HIV-RNA at week 16|||proportion of participants||95% Confidence Interval|Number
1298887|NCT00016718|Primary|Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment.~Comparisons between age groups were not required as per protocol."|At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3|All Participant who enrolled in the study|||proportion of participants||95% Confidence Interval|Number
1298888|NCT00014911|Post-Hoc|Serum Creatinine Levels for Participants in the Extended Follow-up Study Phase|Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT [NCT01309022]). Serum creatinine is a measure of renal function. Normal ranges are from 0.5 to 1.0 mg/dL for females and 0.7 to 1.2 mg/dL for males.|First transplantation through August 30, 2010 (up to 9 years)|Intent-to-Treat|||mg/dL||Full Range|Mean
1298889|NCT00014911|Post-Hoc|HbA1c Plasma Laboratory Values for Participants in the Extended Follow-up Study Phase|Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT [NCT01309022]). Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time. (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher)|First transplantation through August 30, 2010 (up to 9 years)|Intent-to-Treat|||HbA1c Percentage||Full Range|Mean
1298890|NCT00014911|Secondary|Percent of Participants With Detectable Fasting Basal C-Peptide Levels|C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making. C-peptide secretion is used to measure the function of transplanted islets. Higher levels indicate better islet function. Detectable fasting basal levels of C-peptide secretion are >=0.3 ng/ml.|Two years post first transplantation|Intent-to-Treat|||Percent of Participants|||Number
1298891|NCT00014911|Secondary|Percent of Participants That Achieved Insulin Independence From First Transplant|Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1) a blood glycosylated hemoglobin (HbA1c) level < 6.5% (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: <140mg/dL if <=50 years of age, <150 mg/dL for ages 50-60 years and <160 mg/dL for ages 60+)|First transplantation until end of study (up to six years post final transplantation)|Intent-to-Treat|||Percent of Participants|||Number
1298934|NCT00010803|Secondary|Number of Participants With the Indicated Cardiovascular Disease or Mortality|Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality|6 months|Total cohort of 3069 based on same design as primary outcome, ITT.|||Participants|||Number
1298892|NCT00014911|Secondary|Percent of Participants With Partial Islet Function One Year Post Final Islet Transplantation.|Partial islet function definition: a fasting basal C-peptide level >= 0.3 ng/mL and a continuing need for insulin or suboptimal glycemic control (Note: C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making). Adequate glycemic control is defined by: 1) a blood HbA1c level <6.5%, 2) a blood glucose level after an overnight fast not exceeding 140 mg/dL more than three times in any week and, 3) a 2-hour postprandial blood glucose level not exceeding 180 mg/dL more than four times per week|One year post receipt of final islet transplantation|Intent-to-treat|||Percent of Participants|||Number
1298893|NCT00014911|Primary|Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation.|Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1.) a blood glycosylated hemoglobin (HbA1c) level < 6.5% (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: <140mg/dL if <=50 years of age, <150 mg/dL for ages 50-60 years and <160 mg/dL for ages 60+)|One year status post participant receipt of final islet transplantation|Intent-to-treat|||Percent of Participants|||Number
1298894|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 96||Baseline, Week 96|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||percentage of total lymphocytes||Full Range|Median
1298895|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 48||Baseline, Week 48|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||percentage of total lymphocytes||Full Range|Median
1298896|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 20||Baseline, Week 20|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||percentage of total lymphocytes||Full Range|Median
1298897|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 96||Baseline, Week 96|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||cells/mm^3||Full Range|Median
1298898|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 48||Baseline, Week 48|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||Cells/mm^3||Full Range|Median
1298899|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 20||Baseline, Week 20|"Participants accrued at the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||Cells/mm^3||Full Range|Median
1298900|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Clearance (CL/F)|Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0–24hr.|Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.|||L/hr/m^2||Inter-Quartile Range|Median
1298901|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax)|Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually.|Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.|||ng/mL||Inter-Quartile Range|Median
1298902|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24)|Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration.|Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.|||ng/mL||Inter-Quartile Range|Median
1298903|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h)|Pharmacokinetics were determined by non-compartmental analysis and AUC0–24hr calculated by the linear trapezoidal method.|Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.|||ng*hr/mL||Inter-Quartile Range|Median
1298904|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 96|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 96|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."|||percentage of participants||95% Confidence Interval|Number
1298905|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 48|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 48|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."|||percentage of participants||95% Confidence Interval|Number
1298906|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 24|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 24|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."|||percentage of participants||95% Confidence Interval|Number
1298907|NCT00006604|Primary|Number of Participants Who Died||From study entry up to week 96|Participants accrued at the final recommended dose for each group.|||participants|||Number
1298908|NCT00006604|Primary|Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV|"Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment.~The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team."|From study entry up to week 96|Patients accrued at the final recommended dose for each group.|||participants|||Number
1298909|NCT00004978|Secondary|Hepatic, Metabolic, and Cardiac Conditions|"Number of participants experiencing a serious non-AIDS event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy."|From randomization through study end - median of 7.6 years follow-up||||participants|||Number
1298910|NCT00004978|Secondary|Pattern of Use of Prophylaxis for Opportunistic Infections|Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.|last followup visit - median of 7.6 years follow-up|Intention to treat (ITT) - Medication use recorded on the last followup visit attended among all participants attending at least one followup visit.|||participants|||Number
1298911|NCT00004978|Secondary|Grade 4 Signs and Symptoms|Participants with at least one grade 4 sign or symptom (except those limited to a laboratory measurement), other than AIDS-defining conditions. Events were graded according to a standardized toxicity table. Events not specifically contained in the toxicity table were considered Grade 4 if they resulted in extreme limitation in activity or required significant medical intervention/therapy, hospitalization or hospice care. Grade 4 events by type are given under the adverse events section.|From randomization through study end - median of 7.6 years follow-up||||Participants|||Number
1298912|NCT00004978|Secondary|Number of Participants With Changes in Anti-retroviral Treatment (ART)|Number of participants who changed ART at least once during the study period.|From randomization through study end - median of 7.6 years follow-up||||participants|||Number
1298913|NCT00004978|Secondary|Plasma HIV RNA Levels|log10 HIV-RNA averaged throughout follow-up|From randomization through study end - median of 7.6 years follow-up|HIV-RNA measurement averaged over followup visits for all participants with at least one follow-up measurement.|||log10 HIV-RNA||Standard Deviation|Mean
1298914|NCT00004978|Secondary|Absolute CD4 Cell Counts Averaged Throughout Followup|Average of all available CD4+ cell counts measured at follow-up visits|from randomization through study end - median of 7.6 years follow-up|CD4+ cell counts averaged over all participants with at least one CD4+ measurement recorded during follow-up.|||cells/mm^3||Standard Deviation|Mean
1298915|NCT00004978|Secondary|Participants With a New Disease Progression Event or Death|Includes first new episode of: CDC Category C 1993 AIDS-defining events plus invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease|from randomization through 15 November 2008 - median of 7.6 years follow-up||||participants|||Number
1298916|NCT00004978|Secondary|Number of Participants Who Died From Any Cause||from randomization through study end - median of 7.6 years follow-up||||participants|||Number
1298917|NCT00004978|Secondary|New or Recurrent Serious HIV Disease Progression Event Including Death|Patients with at least one: progressive multifocal leukoencephalopathy, lymphoma, visceral Kaposi's sarcoma, AIDS dementia complex, toxoplasmosis, histoplasmosis, cryptococcosis, Mycobacterium avium complex, wasting syndrome, and cytomegalovirus disease.|from randomization through study end - median of 7.6 years follow-up|ITT|||participants|||Number
1298918|NCT00004978|Primary|New or Recurrent HIV Disease Progression Event Including Death|Participants who die or experience at least one: any CDC Category C 1993 AIDS-defining events or one of the following: invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease|from randomization through study end - median of 7.6 years follow-up|ITT|||participants|||Number
1298919|NCT00021541|Other Pre-specified|Median Time to Progression Using the 2-Dimensional World Health Organization (WHO) Solid Tumor Method|Median time to progression is defined as ≥25% increase in area based on volumetric analysis using the 2-dimensional WHO solid tumor method.|8 years|Phase B- Placebo group is not shown because this outcome measure only applies to the Phase A - Tipifarnib group.|||Months||95% Confidence Interval|Median
1298920|NCT00021541|Other Pre-specified|Median Time to Progression Using the Conventional 1-Dimensional Response Evaluation Criteria in Solid Tumors (RECIST) Method|Median time to progression is defined as ≥20% increase in diameter based on volumetric analysis using the 1-dimensional RECIST method. Start of phase A or phase B to time of progression.|8 years|Phase B - Placebo group is not shown because this outcome measure only applies to the Phase A - Tipifarnib group.|||Months||95% Confidence Interval|Median
1298921|NCT00021541|Secondary|Quality of Life (QOL)|"Parents of participants aged 6-18 years completed the Impact of Pediatric Illness (IPI) Scale about their child prior to the start of cycles 1, 4, 7, and 10 and then after every 6 cycles. The IPI Scale assesses QOL in 4 domains: adaptive behavior, emotional functioning, medical/physical status, and cognitive functioning. Responses to the 43 items are made on a 5-point Likert scale (1-5) ranging from not al all to a lot. Higher mean scores indicate better QOL. Parent total scores for participants on placebo were compared with scores from participants receiving tipifarnib on phase A."|Baseline to pre cycle 4|Participants analyzed includes only those whose parents completed the IPI Scale at baseline and pre cycle 4 on phase A.|||Total scores on a scale||Standard Deviation|Mean
1298922|NCT00021541|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|8 years|Adverse event data is in compliance with DSMB (Data Safety Monitoring Board).|||Participants|||Count of Participants
1298923|NCT00021541|Primary|Median Time to Progression|Median time to progression is defined as a greater than or equal to 20% increase increase in the sum of the volume of all index lesions based on volumetric analysis utilizing magnetic resonance imaging (MRI).Start of phase A or phase B to time of progression.|8 years|phase A - 62 started and 2 were ineligible = 60 phase B - 43 started|||Months||95% Confidence Interval|Median
1298924|NCT00018031|Primary|Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response|"HCV viral kinetics were used to predict rates of sustained virology response (SVR) in HIV/HCV connected subjects.~Measure was determined by analyzing the population of participants with virologic decline of more than 1.0 log at day 3 combined with viral load of less than 5.0 log IU/ml at day 28 to predict sustained virology response"|Day 3 and Day 28|Participants with Virologic decline at both Day 3 and absolute HCV VL at Week 28 were analyzed|||participants with post treatment svr|||Number
1298925|NCT00015457|Secondary|Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo|Self reported duration of effect in weeks.|3 months|Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data.|||weeks||Full Range|Median
1298926|NCT00015457|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score|Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.|1-2 month maximal rating|Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data|||units on a scale||Standard Deviation|Mean
1298927|NCT00013611|Secondary|New or Recurrent Serious Disease Progression Events or Death|"Number of participants with fatal or non-fatal serious AIDS-related opportunistic disease.~A serious disease progression event is one of the following: progressive multifocal leukoencephalopathy (PML), lymphoma, Kaposi's sarcoma (visceral), AIDS dementia complex (ADC) stage II or higher, toxoplasmosis, histoplasmosis (systemic), cryptococcosis (systemic), disseminated Mycobacterium avium complex (MAC) disease, wasting syndrome, and cytomegalovirus (CMV) disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier||||Participants|||Number
1298928|NCT00013611|Secondary|CD4+ Cell Count|Mean CD4+ cell count (cells per cubic mm) averaged over follow-up|Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest .||||cells per cubic mm||Standard Error|Mean
1298929|NCT00013611|Secondary|Grade 4 Clinical Events|Grade 4 clinical events were defined as potentially life-threatening events (excluding opportunistic disease) requiring medical intervention.|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|The outcome is the number of participants experiencing at least one grade 4 event.|||Participants|||Number
1298930|NCT00013611|Secondary|New or Recurrent Disease Progression Events|"Number of participants with fatal or non-fatal AIDS-related opportunistic disease.~AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier||||Participants|||Number
1298931|NCT00013611|Secondary|All-cause Mortality|Number of participants who died.|From randomization to date last known to be alive or November 15, 2008, whichever is earlier||||Participants|||Number
1298932|NCT00013611|Primary|New or Recurrent Disease Progression Events, as Defined, or Death.|"Number of participants with fatal or non-fatal AIDS-related opportunistic disease or death from any cause.~AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier||||Participants|||Number
1298933|NCT00010803|Secondary|Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.|Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline).|6 months/annually|Final test scores were imputed for participants who did not have a cognitive exam during the year before death (n=234) or dropout (n=154) or during the month before censoring for dementia (n=70). Factors in imputed model included treatment group, demographic and health history variables, study site, and other cognitive scores. Higher Z-scores worse|||Z-score units||95% Confidence Interval|Mean
1298955|NCT00006409|Primary|MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)||Post-3 year intervention||||Minutes of MET-weighted MVPA˙||Standard Error|Mean
1298935|NCT00010803|Primary|Number of Participants With Incident Dementia|All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process.|Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up|Subjects developing incident dementia during trial in each group, intention to treat (ITT).|||Participants|||Number
1298936|NCT00010439|Secondary|Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.|Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy.|Before and 12 months after treatment with alendronate|Per protocol|||participants|||Number
1298937|NCT00010439|Primary|Number of Participants With Increased Bone Mineral Density|Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)|at 12 months|per protocol|||participants|||Number
1298938|NCT00007644|Primary|All Cause Mortality|Bi-annually, from date of randomization until the date of death from any cause, assessed up to 8 years.|bi-annual||||percentage of participants||95% Confidence Interval|Number
1298939|NCT00007644|Primary|All Cause Mortality|Annually, from date of randomization until the date of death from any cause, assessed up to 8 years.|Annual|||||||
1298940|NCT00007475|Secondary|Determine Whether Renal Transplantation in Patients Whose Elevated FPF Levels Have Been Reduced for a Sustained Period is Associated With a Reduced Prevalence of Recurrent FSGS.|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|Participants whose post-transplantation follow-up yields 1 or more assayed FPF levels||||||
1298941|NCT00007475|Secondary|Correlate the Effect of Immunosuppressive Agents Which Reduce Proteinuria in Recurrent FSGS With the Effect on FPF Levels|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|Participants with FPF levels assayed following immunosuppressive therapies (currently none). Note: its assay had not yet been developed to an extent that it could be applied beyond the provisional values assayed for 3 of the first 4 enrollees using a version implemented by Dr.Virginia Savin, VA Medical Center/Kidney Institute, Kansas City, Missouri||||||
1298942|NCT00007475|Secondary|Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange.|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study||||1- albumin glomerular permeability ratio||Full Range|Mean
1298943|NCT00007475|Secondary|Comparison of RNA Expression Profiles in PBMC From Patients With FPF, Without FPF and Control Subjects|"No RNA expression profiles have been obtained as FSGS Permeability Factor (FPF) levels NOT available -- its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial.~Note that provisional values (targeting current candidate molecule: cardiotrophin-like cytokine 1) were assayed for 3 of the first 4 enrollees using assay by Dr. Virginia Savin, whose lab is actively investigating a molecular identification of FPF using an isolation approach based on sequential precipitation results in a 100-fold purification, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF include:~Terry Phillips at NIH developed an assay that looked promising but after his retirement it has not been possible for other researchers to get this working.~Avi Rosenberg, NCI has developed a promising ELISA-style assay, as well as some work in a mass spectrometry assay, and this is being further refined."|End of study|Participants with FPF, without FPF and control subjects who have also had RNA expression profiling done in PBMCs.||||||
1299038|NCT00001959|Primary|Decrease in GFR During Treatment Period||12 months from baseline|ITT|||ml/min/1.73 m2||Inter-Quartile Range|Mean
1298944|NCT00007475|Primary|Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide.|"Outcomes for FSGS occurring in native kidneys:~A. Complete remission: proteinuria <0.3 g/d ; B. Partial remission: proteinuria between 0.3 and 2 g/d ; C. Incomplete response: proteinuria between 2 and 3.5 g/d ; D. Relapse: return to proteinuria ≥3.5 g/d ; Note that counts within each category A-D may be summarized relative to remaining categories, as a proportion (relative to complement of the whole group count) with calculations implicitly based on zero/one valued binary variables, whose means are proportions, so to report 95% confidence intervals calculated using an exact binomial distribution."|every 3 months up to a year followed with native kidneys|all participants, regardless of amount of follow-up|||proportion of participants with outcome||95% Confidence Interval|Mean
1298945|NCT00007345|Secondary|Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression|Total ribonucleic acid (RNA) was isolated from peripheral blood mononuclear cells or patient tissue biopsies and analyzed by quantitative polymerase chain reaction (qPCR). Expression of MDR-1/ABCB1 was determined by qPCR relative to an RNA standard, then normalized to ribosomal RNA (rRNA). Fold change is calculated by dividing the level of MDR-1 in a treated sample (at 4, 24, and 48 hours) measured by qPCR, divided by MDR-1 in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).|4 hours, 24 hours, and 48 hours after Romidepsin|ABCB1 expression of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.|||Fold change||Full Range|Median
1298946|NCT00007345|Secondary|Fold Change in Histone Acetylation|Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).|4 hours, 24 hours, and 48 hours after Romidepsin|Global histone acetylation of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.|||Fold change||Full Range|Median
1298947|NCT00007345|Secondary|Time to Progression|Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|Until disease progression, or 30 days following off study date||||Months||95% Confidence Interval|Median
1298948|NCT00007345|Secondary|Median Number of Cycles of Depsipeptide Administered|Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.|83 cycles (i.e., each cycle is 21 days)||||Cycles per patient||Full Range|Median
1298949|NCT00007345|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|147 months and 5 days||||participants|||Number
1298950|NCT00007345|Primary|Duration of Response (DOR)|DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|up to 127 months||||Months||Full Range|Median
1298951|NCT00007345|Primary|Number of Participants With a Response|A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|up to 56.5 days|Two participants were excluded. After further analysis it was determined that the participants did not have PTCL but a different form of lymphoma that was not known at the onset of enrollment.|||participants|||Number
1298952|NCT00006489|Secondary|Penn Alcohol Cravings Scale|The Penn Alcohol Craving Scale is a 5-item self-report measure. It assesses alcohol craving during the prior week. Total scores on this measure range from 0 to 30, with higher scores indicating a higher level of craving.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)||||percentage of days||95% Confidence Interval|Mean
1298953|NCT00006489|Primary|Drinking Timeline Follow-back Interview (TFBI)|The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)||||percentage of days||95% Confidence Interval|Mean
1298954|NCT00006489|Primary|Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)|The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)||||units on a scale||95% Confidence Interval|Mean
1298958|NCT00006305|Primary|Number of Participants With All-Cause Mortality||five years|Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)|||participants|||Number
1298959|NCT00006289|Primary|McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)|"Assessments of pain severity by the patient using a McGill Pain Questionnaire which consists of 3 major classes of word descriptors-sensory, affective and evaluative - that are used by patients to specify subjective pain experience. Each word chosen from descriptor responses to 20 questions is given a value and the sum of the values of the responses provides a score which is an index of the pain severity with a minimum value of 20 and a maximal value of 78. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators are blinded to the treatment code (drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.||||units on a scale||Standard Error|Mean
1298960|NCT00006289|Primary|Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)|"Assessments of pain severity by the patient using a numeric rating scale ranging from 0 to 10 as a verbal response where 0 = no pain and 10 =maximal pain. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while the investigators are blinded to the treatment code (Drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.||||units on a scale||Standard Deviation|Mean
1298961|NCT00006289|Primary|Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )|"Assessments of pain severity by the patient using a visual analogue scale ranging from 0 to 100 (mm), with 0 = no pain and 100 = maximal pain level. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators were blinded to the treatment code (Drug A and B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.||||mm||Standard Error|Mean
1298962|NCT00006184|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|9 years||||Participants|||Count of Participants
1298963|NCT00006184|Primary|Immune Response|Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.|105 days|This outcome measure was only pre-specified to be measured in the recipient Arm/Group.|||Particpants|||Number
1298964|NCT00006178|Secondary|Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)|measure at 12 months after intervention|12 months after intervention||||mL/min||Standard Deviation|Mean
1298965|NCT00006178|Primary|Serum Creatinine Concentration|measures at 12 months after intervention|12 months after intervention||||umol/L||Standard Deviation|Mean
1298966|NCT00006178|Primary|Serum Creatinine Concentration|measures at 6 months after intervention|6 months after intervention|Analysis includes all participants in the study. Analysis was per protocol.|||umol/L||Standard Deviation|Mean
1298967|NCT00006178|Secondary|Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)|measure 6 months after intervention|6 month after intervention||||mL/min||Standard Deviation|Mean
1298968|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|12 months|Participants with available data at 12mo. All others were unable to provide data at this time point.|||percentage of participants|||Number
1298969|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|6 months|Participants with available data at 6mo. All others were unable to provide data at this time point.|||percentage of participants|||Number
1298970|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|3 months|Participants with available data at 3mo. All others were unable to provide data at this time point.|||percentage of participants|||Number
1298971|NCT00006156|Secondary|Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels||24 hours||||participants||Standard Error|Mean
1298972|NCT00006156|Primary|Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.||24 hours||||participants||Standard Error|Mean
1298973|NCT00006164|Secondary|SF-36 Mental Health Summary Score|Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Mental Health summary score. The SF-36 Mental Health summary score is the sum of 5 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.|0.5, 1.5, 2.5, and 3.5 years after randomization|At each visit the analysis population is the number who completed the questionaire|||units on a scale||Standard Deviation|Mean
1298974|NCT00006164|Secondary|SF-36 Physical Function Summary Score|Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Physical Function summary score. The SF-36 Physical Function summary score is the sum of 10 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.|0.5, 1.5, 2.5, and 3.5 years after randomization|At each visit the analysis population is the number who completed the questionaire|||units on a scale||Standard Deviation|Mean
1298975|NCT00006164|Secondary|SF-36 Vitality Summary Score|Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Vitality summary score. The SF-36 Vitality summary score is the sum of 4 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.|0.5, 1.5, 2.5, and 3.5 years after randomization|At each visit the analysis population is the number who completed the questionaire|||units on a scale||Standard Deviation|Mean
1298976|NCT00006164|Secondary|Presumed Hepatocellular Carcinoma (HCC)|"Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is <1000 ng/ml, if:~A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC.~AFP> upper limit of normal (ULN) and 2 imaging studies showed a hepatic lesion with characteristics of HCC.~A progressively enlarging hepatic lesion starting as a new defect resulting in patient death.~A new hepatic defect with at least 1 characteristic scan and:~Increase in size over time or~Increasing AFP rising to a level of >200 ng/ml"|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298977|NCT00006164|Secondary|Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.|Change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) by assessment of a liver-biopsy specimen obtained during the study (collected at baseline, Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)|1400 days (3.85 years) post randomization|Numbers of participants at 1.5 and 3.5 years are the number with biopsies at those time points|||units on a scale||Standard Deviation|Mean
1298978|NCT00006164|Secondary|Serious Adverse Events|"A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following:~Death~Is life threatening (risk of death at the time of the event)~Requires in-patient hospitalization or prolongation of existing hospitalization~Results in persistent or significant disability/incapacity~Congenital abnormality or birth defect~Trial outcomes (except death) were not considered serious adverse events."|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298979|NCT00006164|Primary|Hepatic Encephalopathy|Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause).|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298980|NCT00006164|Primary|Spontaneous Bacterial Peritonitis|Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability.|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298981|NCT00006164|Primary|Ascites|"Any abdominal fluid which is:~Mild, moderate or marked on ultrasound; or~Progressive on serial physical examinations; or~Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is “mild” (“barely detectable”) on physical examination requires ultrasound confirmation that is “mild”, “moderate” or “marked” ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition."|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298982|NCT00006164|Primary|Variceal Hemorrhage|A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298983|NCT00006164|Primary|Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits|Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation)|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298984|NCT00006164|Primary|Development of Hepatocellular Carcinoma (HCC)|"A diagnosis of development of hepatocellular carcinoma (HCC) was based on either~Histology showing HCC (from a biopsy, surgery, or autopsy) or~A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to > 1,000 ng/ml."|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298985|NCT00006164|Primary|Death From Any Cause||1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298986|NCT00006164|Primary|Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies|For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)|1400 days (3.85 years) post randomization|Patients with Ishak fibrosis score <5 at baseline and at least one follow-up biopsy|||Participants|||Count of Participants
1298987|NCT00006164|Primary|Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points|Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
1298988|NCT00006151|Primary|Abstinence Rate|The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.|1 year||||participants|||Number
1298989|NCT00005937|Primary|Red Blood Cell Transfusion Independence|Red blood cell transfusion independence was documented as time from last transfusion of red cells to last day of transfusion free follow-up. Independence or response to the intervention was assessed by weekly blood counts. Transfusion independence was defined as no transfusion requirement for a 3 month period. Complete hematologic response is defined as the normalization of affected cells lines and less than 5% marrow blasts present. Partial hematologic response is defined as greater than 50% improvement from baseline to normal levels of all cell counts and greater than 50% decrease in marrow blasts.|6 months||||participants|||Number
1298990|NCT00005908|Primary|Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models|Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.|6 years|"Specimens from 21 patients. Analysis was per protocol and included only those patients with adequate RNA (ribonucleic acid) for analysis. Since both had the same intervention, the sample size was small, and a dose response was not expected, all patients were analyzed together."|||Participants|||Number
1298991|NCT00005908|Primary|Complementary Deoxyribonucleic Acid (cDNA) Expression|Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.|6 years||||Participants|||Number
1298992|NCT00005908|Primary|Overall Clinical Response Rate|Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module.|6 years|Combined data from 2 dose levels in 29 evaluable patients.|||Percentage of participants|||Number
1298993|NCT00005908|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|6 years||||Participants|||Number
1298994|NCT00005906|Secondary|Number of Participants With Liver Function Abnormalities|"One or more abnormality of the following liver function tests:~Alkaline phosphatase above 116 i.u.~SGPT above 41 i.u.~SGOT from 34 i.u.~Total bilirubin above 1.0 mg/dl"|Six months||||Participants|||Number
1298995|NCT00005906|Primary|Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms.|"Octreotide treatment will be considered successful if the reported pain/symptom score is reduced by at least 2 levels at termination of treatment.~A simple visual numeric distress scale ranging from zero to 10 will be employed to rate the severity of individual symptoms. The best score is zero, which means absence of symptoms and the maximal is 10, meaning that the symptoms are very severe."|Six months|Four patients with lymphangioleiomyomatosis and lymphangioleiomyomas and chylous effusions treated with octreotide injections by the subcutaneous route to determine whether the size of the tumors and effusions decrease with the therapy|||Participants|||Number
1298996|NCT00005906|Primary|Number of Participants With a Reduction in Total Tumor Volume of at Least 20%.|Octreotide treatment will be considered successful if the patient receiving treatment for six months shows a reduction in total tumor mass/ fluid collection or reaccumulation of at least 20%.|Six months||||Participants|||Number
1298997|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 6 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
1298998|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 36 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
1298999|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 30 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
1299000|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 24 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
1299001|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 18 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
1299002|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 12 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
1299003|NCT00005669|Secondary|Change in Body Fat by Bod Pod|Change in body fat mass measured by air displacement plethysmography (kg)|6 months||||kg||95% Confidence Interval|Mean
1299004|NCT00005669|Secondary|Change in Body Fat by DEXA|Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg)|6 months|ITT, multiple imputation model for missing data under a missing-at-random assumption|||kg||95% Confidence Interval|Mean
1299005|NCT00005669|Secondary|Change in Body Weight|Change in body weight (kg)|6 months||||kg||95% Confidence Interval|Mean
1299006|NCT00005669|Secondary|Change in Body Weight as Determined by BMI|Change in body weight as determined by body mass index (kg/m2)|6 months||||kg/m2||95% Confidence Interval|Mean
1299007|NCT00005669|Primary|Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).|Change in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile_data_files.htm for details.|6 months||||Units on a scale||95% Confidence Interval|Mean
1299008|NCT00004980|Secondary|Responder Status|"Responder defined as a participant who attains an endpoint hallucination change score (HCS) of 5 or lower after 9 active/shame rTMS sessions.~Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline"|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|LOCF|||Participants|||Number
1299009|NCT00004980|Secondary|Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions|Scaled from 1-7 as follows: 1=dramatically improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worsened, 6=moderately worsened, 7=dramatically worsened|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)||||Units on a scale||Standard Deviation|Mean
1299010|NCT00004980|Secondary|Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions|Difference between baseline hallucination frequency and hallucintion frequency at last assessment. Assessed on the basis of a 0-9 scale, with higher scores being more severe.|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|LOCF|||Score on a scale||Standard Deviation|Mean
1299011|NCT00004980|Primary|Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions|Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|Last Observation Carried Forward (LOCF)|||Units on a scale||Standard Deviation|Mean
1299012|NCT00004732|Secondary|Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).|4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.|4 years||||Percentage||Standard Error|Mean
1299013|NCT00004732|Primary|Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.|The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (>=50%) or asymptomatic (>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.|30 days and 4 years||||Percentage||Standard Error|Mean
1299014|NCT00004635|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|Date treatment consent signed to date off study, approximately 60 months||||Participants|||Count of Participants
1299015|NCT00004635|Primary|Time to Progression|Time to progression is defined as follows: if the PSA returns to baseline (defined as the PSA value prior to starting leuprolide or goserelin) or increases to the absolute value of 5 ng/ml.|36 months|Per protocol. First intervention phase-73 participants (thalidomide) were analyzed and 0 was excluded; 74 participants were analyzed (placebo) and 1 was excluded for discrepancy in data entry. Crossover phase-50 participants were analyzed (thalidomide)and 1 was excluded for discrepancy in data entry, 38 participants for placebo and 0 excluded.|||months||95% Confidence Interval|Median
1299016|NCT00004563|Secondary|DLCO|diffusing capacity of the lungs for carbon monoxide|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.|||% of predicted||Standard Error|Mean
1299017|NCT00004563|Secondary|Total Lung Capacity|expressed as a percentage of the predicted value|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.|||% of predicted||Standard Error|Mean
1299018|NCT00004563|Primary|Forced Vital Capacity|The primary end point was the forced vital capacity (FVC, expressed as a percentage of the predicted value) at 12 months, after adjustment for the baseline FVC.|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.|||% of predicted||Standard Error|Mean
1299019|NCT00004562|Secondary|Number of Participants With Secondary Outcomes (Safety Events)|Number of Participants with Secondary Outcomes (death from any cause, nonfatal MI, class IV HF, cardiac death, occurrence of selected clinical outcomes including stroke, hospitalization for CHF, sustained ventricular tachycardia/ventricular fibrillation, ICD implantation, or the composite end point). Events were centrally adjudicated.|Measured over a maximum 9-year follow-up period - 6 year median||||participants|||Number
1299020|NCT00004562|Primary|Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF)|Number of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.|Measured over a maximum 9-year follow-up period - 6 year median||||participants|||Number
1299021|NCT00004547|Secondary|Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue|Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.|once during surgery|This outcome measure was not analyzed because it was not feasible.||||||
1299022|NCT00004547|Secondary|Quality of Life Questionnaire Score|"The Short-Form-36 Health Survey (SF-36) and the Functional Assessment of Cancer Therapy Disease Specific for Colorectal Cancer (FACT-C) will be given to the patients upon admission preoperatively, then 6 weeks postoperatively, and then 3, 6, 9, and 12 months for the first year and then every 6 months until the patient goes off study. These forms summarize a participants positive and negative aspects that characterize one's psychological (emotional(, physical, and social well-being at a point in time.~For detailed information about the questionnaires, please see the Protocol Link module."|preop, 6 weeks postop and then 3, 6, 9, and 12 months the first year and then every 6 months until the patient is off study|This outcome measure was not evaluated due to poor patient compliance.||||||
1299023|NCT00004547|Secondary|Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed|Paclitaxel and 5-FU levels in plasma and perfusate will be determined by standard high-performance liquid chromatography (HPLC). Samples will be collected just prior to (Time 0) the infusion of the intraperitoneal dwell of 5-FU and paclitaxel, at the following time intervals after the conclusion of the intraperitoneal dwell infusion (15 minutes, 1 hour, 6 hour, 12 hour, 24 hour, 48 hour).|Perioperative day 7-12 after surgery|This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).||||||
1299024|NCT00004547|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|only assessed during the perioperative period (i.e. up to 90 days following surgery)|188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P. Meso + 48 L. Grade + 57 Adeno. = 188).|||Participants|||Number
1299025|NCT00004547|Primary|Number of Participants With a Response|Response is assessed by measuring the time to clinical or radiographic recurrence of disease. Patients will be followed with computed tomography (CT) scans. At any time point where there is evidence of progressive disease in the peritoneal cavity (imageable tumor nodules or new onset of ascites) the patients will be scored as failing within the abdominal cavity.|Patients were assessed every three months for one year and then every 6 months||||Participants|||Number
1299026|NCT00004547|Primary|Number of Participants With Disease-free Survival|Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.|On study date until the first scan with imageable disease, assessed up to 100 months or more.|This outcome measure was not analyzed because information was not consistently available.||||||
1299027|NCT00001984|Secondary|Monocyte Count||4 day post operation||||cells/mm3||Full Range|Median
1299028|NCT00001984|Primary|Rise in Serum Creatineine Above Posttransplant Nadir||24-32 days post operation||||parcentage rise in serum creatineine||Full Range|Median
1299029|NCT00001984|Secondary|Creatinine at 2 Years|Creatinine level of donor recepient at 2 years after transplantation|2 years post operation||||mg/dL||Standard Deviation|Mean
1299030|NCT00001984|Secondary|Creatinine Level at Year 1 Post Operation||1 year post operation||||mg/dL||Standard Deviation|Mean
1299031|NCT00001984|Secondary|Creatinine Level at 6 Month Post Operation||6 month post operation||||mg/dL||Standard Deviation|Mean
1299032|NCT00001984|Primary|Rejection Day of Onset|The day on which the rejection onsets.|From day 1 to 2 years post operation||||day||Full Range|Median
1299033|NCT00001984|Primary|Number of Patients With Renal Allograft Rejection|The renal allograft tolerance was evaluated clinically, by flow cytometry, and by protocol biopsies analyzed immunohistochemically and with real-time polymerase chain reaction.|from day 1 to 24 months post operation||||participant|||Number
1299034|NCT00001962|Secondary|Change in the Transfusion Requirements, Overall Survival.||3 and 6 months|||||||
1299035|NCT00001962|Primary|Daclizumab Hematologic Response|"Daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment. The Diamond Blackfan anemia arm was closed due to the lack of accrual. The hematologic response will be evaluated at 3 months.~A complete hematologic response will be considered an achievement of normal blood counts. A partial response was defined as any response less than a complete response. The primary endpoint was a hematologic response in at least one affected peripheral blood count parameter, as determined by 3 separate measurements in the first 12 weeks after completion of the infusion."|3 months|The daclizumab hematologic response was evaluated for subjects diagnosed with moderate aplastic anemia (MAA) and pure red cell aplasia (PRCA). The Diamond Blackfan arm was closed due to lack of accrual.|||participants|||Number
1299036|NCT00001959|Secondary|Proportion of Patients With Positive Change in GFR||12 months from baseline||||participants|||Number
1299040|NCT00001941|Primary|Percentage of Participants With an Overall Response Rate|Participants overall response rate was defined as complete response (CR) + partial response (PR) from study consent until progression was measured. Responses was assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; and progressive disease is a >=25% increase in leukemic cell count|up to 220 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.|||Percentage of participants|||Number
1299041|NCT00001941|Primary|Overall Survival|Measured from the time the patient is consented until death.|132.6 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.|||Weeks||95% Confidence Interval|Median
1299042|NCT00001941|Primary|Duration of Response|Duration of response was defined as the interval from the time response is first achieved to the time progression from the best response is detected. Responses are assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; stable disease is patients who did not meet the criteria; and progressive disease is a >=25% increase in leukemic cell count.|21-220 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.|||Weeks||Full Range|Median
1299043|NCT00000392|Secondary|Change in Neurocognitive Performance Domain z Scores From Baseline|Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)|Baseline and 6 months||||z score||Standard Error|Mean
1299044|NCT00000392|Primary|Change in Global Neurocognitive Performance z Score From Baseline|Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)|Baseline and 6 months||||z score||Standard Error|Mean
1299045|NCT00001832|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|10.5 months||||Participants|||Number
1299046|NCT00001832|Primary|Clinical Response|Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.|Every three to four weeks after the treatment, for up to 5 years.||||Participants|||Number
1299047|NCT00001723|Secondary|Effect of Race on Change in Weight (kg)|Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black)|baseline to 6 months|Multiple imputation analysis|||kg||Standard Error|Mean
1299048|NCT00001723|Secondary|Change in Body Fat (kg)|body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA)|baseline to 6 months|Multiple Imputation analysis|||kg||Standard Error|Mean
1299049|NCT00001723|Secondary|Change in Body Mass Index|BMI is calculated in kg/m2. Change from baseline to 6 months of treatment|baseline to 6 months|Muliple imputation analysis|||kg per square meter||Standard Error|Mean
1299050|NCT00001723|Secondary|Change in Body Weight|Weight in kg|baseline to 6 months|Multiple imputation analysis|||kg||Standard Error|Mean
1299051|NCT00001723|Primary|Change in BMI Standard Deviation Score|Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190.|baseline to 6 months|Multiple imputation analysis|||Standard Deviation Score||Standard Error|Mean
1299052|NCT00001703|Secondary|The Number of Participants With Adverse Events.|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|88 months||||participants|||Number
1299053|NCT00001703|Primary|Percentage of Participants Who Generated an Immune Response|The immunological response was assessed by in-vitro T cell cytokine production enzyme-linked immunosorbent spot (ELISPOT). From each patients, post-vaccination peripheral blood mononuclear cells (PBMC) were compared to pre-vaccination as a baseline. A positive ELISPOT result for the patients was defined as a total number of experimental spots in the post-vaccination sample of more than twofold above the total spots in the pre-vaccination sample.|30 months||||percentage of participants|||Number
1299054|NCT00001656|Other Pre-specified|Change in Extrapyramidal Movements as Measured by the Simpson Angus Scale Score|minimum score = 10; maximum score = 90; lower score considered a more favorable outcome|8 week double-blind study period; baseline and 8 weeks||||scores on a scale||95% Confidence Interval|Median
1299055|NCT00001656|Other Pre-specified|Change in Extrapyramidal Movements as Measured by the Abnormal Involuntary Movements Scale (AIMS)|minimum score = 10; maximum score = 50; lower score is considered a more favorable outcome|8 week double-blind study period; baseline and 8 weeks||||scores on a scale||Full Range|Median
1299056|NCT00001656|Other Pre-specified|Change in Body Mass Index (BMI)|BMI is calculated by the following formula: weight (in kilograms) divided by the square of the height (in meters)|8 week double-blind study period; baseline and 8 weeks||||kg/m²||Standard Deviation|Mean
1299057|NCT00001656|Other Pre-specified|Change in Weight||8 week double-blind study period; baseline and 8 weeks||||kilograms||Standard Deviation|Mean
1299058|NCT00001656|Primary|Change in the Bunney-Hamburg Rating Scale for Anxiety|Measures change in the severity of anxiety; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
1299059|NCT00001656|Primary|Change in Bunney-Hamburg Rating Scale for Mania|Measures change in the severity of mania; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
1299060|NCT00001656|Primary|Change in Bunney-Hamburg Rating Scale for Depression|Measures change in severity of depression; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
1299061|NCT00001656|Primary|Change in the Bunney-Hamburg Rating Scale for Psychosis|Measures change in psychosis severity; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
1299062|NCT00001656|Primary|Change in the Scale for the Assessment of Positive Symptoms|Measures change in hallucinations, delusions, bizarre behavior, and thought organization. Minimum score = 0; maximum score = 170; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
1299063|NCT00001656|Primary|Change in the Brief Psychiatric Rating Scale-24|A 24-item scale measuring change in interpersonal behaviors, mood, psychosis, anxiety, speech, sleep, orientation and physical activity. Lowest score = 24; highest score = 168; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
1299064|NCT00001656|Primary|Change in the Clinical Global Impression Severity of Symptoms Scale|Measures change in the severity of symptoms; Minimum score = 1; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
1299065|NCT00001656|Primary|Change in the Scale for the Assessment of Negative Symptoms|Measures change in affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, attention; minimum score = 0; maximum score = 125; lower values are considered a better outcome|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
1299066|NCT00001596|Secondary|Change in 6 Minute Walk Test (12 Months)|Change from baseline of the 6 minute walk test (6MWT) at 12 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data is available at baseline and 12 months.|||meters||Standard Deviation|Mean
1299067|NCT00001596|Secondary|Change in 6 Minute Walk Test (36 Months)|Change from baseline of the 6 minute walk test (6MWT) at 36 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data is available at baseline and 36 months.|||meters||Standard Deviation|Mean
1299068|NCT00001596|Secondary|Change in Adjusted Diffusing Capacity of the Lung for Carbon Monoxide (12 Months)|Change from baseline in adjusted Diffusing Capacity of the lung for carbon monoxide (DLCOa) measured at 12 months. DLCOa measures gas uptake during a single inspiration in a standard time, adjusted for subject's hemoglobin levels.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data is available at baseline and 12 months.|||% of predicted volume||Standard Deviation|Mean
1299069|NCT00001596|Secondary|Change in Adjusted Diffusing Capacity of the Lung for Carbon Monoxide (36 Months)|Change from baseline in adjusted Diffusing Capacity of the lung for carbon monoxide (DLCOa) measured at 36 months. DLCOa measures gas uptake during a single inspiration in a standard time, adjusted for subject's hemoglobin levels.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data was available at baseline and 36 months.|||% of predicted volume||Standard Deviation|Mean
1299070|NCT00001596|Secondary|Change in Total Lung Capacity (12 Months)|Change from baseline in Total Lung Capacity (TLC) measured at 12 months. TLC is the volume in the lungs at maximal inflation. TLC is recorded as the percentage of predicted volume based on subject's height, age, sex, and weight.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data was available at baseline and 12 months.|||% of predicted volume||Standard Deviation|Mean
1299071|NCT00001596|Secondary|Change in Total Lung Capacity (36 Months)|Change from baseline in Total Lung Capacity (TLC) measured at 36 months. TLC is the volume in the lungs at maximal inflation. TLC is recorded as the percentage of predicted volume based on subject's height, age, sex, and weight.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data is available at baseline and 36 months.|||% of predicted volume||Standard Deviation|Mean
1299072|NCT00001596|Secondary|Change in Forced Vital Capacity (12 Months)|Change from baseline in the Forced Vital Capacity (FVC) measurement at 12 months. FVC is the volume of air that can be forcibly blown out from the lungs after full inspiration. FVC is recorded as the percentage of predicted volume (predicted FVC volume is calculated based on subject's height, age, sex, and weight).|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data was available at baseline and 12 months.|||% of predicted volume||Standard Deviation|Mean
1299073|NCT00001596|Primary|Change in Forced Vital Capacity (36 Months)|Change from baseline in the Forced Vital Capacity (FVC) measurement at 36 months. FVC is the volume of air that can be forcibly blown out from the lungs after full inspiration. FVC is recorded as the percentage of predicted volume (predicted FVC volume is calculated based on subject's height, age, sex, and weight).|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data was available at baseline and 36 months.|||% of predicted volume||Standard Deviation|Mean
1299074|NCT00001586|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|13 years, 10.5 months|The low-intermediate risk patients received no treatment so their tissue/blood was not analyzed for change.|||Participants|||Number
1299075|NCT00001586|Primary|Change in Gene Expression Post Chemo|Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a >50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells.|6 hours post treatment, and 24 hours post treatment|There were only 12 patients analyzed for various reasons such as timing of treatment, ability to collect samples, and viability of samples.|||Percent change in cells|||Number
1299076|NCT00001575|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|16 yrs 18 days||||participants|||Number
1299105|NCT00000378|Primary|HAMILTON Rating Scale for DEPRESSION Range|Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement|BASELINE COMPARED TO 12 WEEK MEASUREMENT|intent to treat analysis|||units on a scale||Standard Deviation|Mean
1299077|NCT00001575|Primary|Clinical Response|Clinical Response of patient is measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor responses were evaluated by In-HAT imaging (i.e., simultaneous with administration of therapeutic 90Y-daclizumab), Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scans and computed tomography (CT) scans. Complete response is a disappearance of all measurable and evaluable disease lasting more than I month. Partial response is a reduction by ≥ 50% of leukemic cell count or ≥ 50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesions for 1 month. Stable disease is less than partial response with no more than a 25% increase in leukemic cell count, no new lesions, or less than a 25% increase in any measurable lesion. Progressive disease is at least a 25% increase in leukemic cell count, appearance of new lesions, or an increase of 25% or greater in any measurable lesion after 2 weeks.|Patient would be measured with computed tomography (CT) scan, Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scan in 28 days before treatment. Patient would be evaluated with In-HAT imaging at Day 1,4,5,6 and Day 7 in week 1 of each cycle.|Phase II portion. Only the Hodgkin's participants was analyzed (i.e., added more Hodgkins participants to study).|||participants|||Number
1299078|NCT00001575|Primary|Maximum Tolerated Dose (MTD) of 90Y-HAT|Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy.|Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks.|Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28).|||mci|||Number
1299079|NCT00001566|Secondary|Median Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|5.4 years||||Years||Full Range|Median
1299080|NCT00001566|Primary|Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation|Immune response was defined as a percent specific lysis of >10% following challenge with tumor peptide pulsed targets, or interferon gamma production following challenge with tumor peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0 to tumor peptide targets.Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. See protocol link module for additional information re: peptides.|Once per enrollment||||Participants|||Number
1299081|NCT00001566|Primary|Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7|Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0.|5 years|12 patients were human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+) and therefore evaluable for response to E7 peptides.|||Participants|||Number
1299082|NCT00001566|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years||||Participants|||Number
1299083|NCT00001566|Secondary|Percent of Participants: Event Free Survival|Event free survival is calculated from the date of diagnosis for patients enrolled with newly diagnosed metastatic disease and from the date of the last recurrence detection before enrollment on this study for patients with recurrent disease.|5 years||||Percentage of participants|||Number
1299084|NCT00001566|Secondary|Percentage of Participants Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|5 years||||Percentage of participants|||Number
1299085|NCT00001566|Primary|Number of Participants With an Immune Response to the Translocation Breakpoint Peptide|Immune responses were measured following 3 sequential influenza vaccines during the same period as the peptide-pulsed dendritic cell vaccines.|5 years||||Participants|||Number
1299086|NCT00001566|Primary|The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy|CD4 counts were measured from peripheral blood using standard flow cytometric techniques at the following timepoints: 2 months post-chemotherapy, 4 months post-chemotherapy and 6 months post-chemotherapy. To be eligible for evaluation for this endpoint, patient much have been <10 years of age and sustained a CD4 count of <300 cells/mcl upon completion of standard therapy. Recovery was defined as a CD4 count > 500 cells/mcl at any timepoint within 6 months of completing chemotherapy.|2 to 6 months||||Percentage of participants|||Number
1299087|NCT00001566|Primary|Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution|Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0. Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. Non-tumor specific peptide:HPV16E7 MLDLQPETT-MET-9-THR. See protocol link module for additional information re: peptides.|20 weeks post vaccination||||Participants|||Number
1299088|NCT00001304|Primary|Urine Calcium Excretion Level|Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||mmol/24 h||Standard Deviation|Mean
1299089|NCT00001304|Secondary|Urinary Creatinine Clearance|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ml/min, normal range 90-125. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||ml/min||Standard Deviation|Mean
1299090|NCT00001304|Secondary|Serum Phosphorus Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.7-1.4. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||mmol/liter||Standard Deviation|Mean
1299091|NCT00001304|Secondary|Serum Magnesium Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.65-1.05. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||mmol/liter||Standard Deviation|Mean
1299092|NCT00001304|Primary|Serum Calcium Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||mmol/liter||Standard Deviation|Mean
1299093|NCT00001304|Secondary|Serum 25-hydroxyvitamin D Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ng/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||ng/ml||Standard Deviation|Mean
1299094|NCT00001304|Secondary|Serum 1,25-hydroxyvitamin D Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = pg/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||pg/ml||Standard Deviation|Mean
1299095|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Head Circumference Percentile||36 months or death||||Other - Percentile||Standard Deviation|Mean
1299096|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Length Percentile||36 months or death||||Other - Percentile||Standard Deviation|Mean
1299097|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Weight Percentile||36 months or death||||Other - Percentile||Standard Deviation|Mean
1299098|NCT00001262|Primary|Language Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate language development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death||||Other - Months||Standard Deviation|Mean
1299099|NCT00001262|Primary|Personal-Social Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate personal-social development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death||||Other - Months||Standard Deviation|Mean
1299100|NCT00001262|Primary|Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate fine motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death||||Other - Months||Standard Deviation|Mean
1299101|NCT00001262|Primary|Gross Motor Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate gross motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death||||Other - months||Standard Deviation|Mean
1299102|NCT00001213|Primary|Number of Eyes With a Corneal Cystine Crystal Score (CCCS) Response|"Response is defined as a decrease from baseline of at least 1 in Corneal Cystine Crystal Score (CCCS) at any time on study when baseline CCCS is greater than or equal to 1, or CCCS does not increase at least 1 at any time on study when baseline CCCS is less than 1.~The CCCS is based on a library of slit-lamp photographs of corneas with increasing crystal densities (0-3). Slit-lamp photos were to be taken to assess the extent of the corneal crystal accumulation. To minimize bias when assessing the extent of corneal crystal accumulation, photos were centrally graded at the National Eye Institute (NEI) where each photo was graded independently by masked graders. If more than one CCCS was recorded in a given study year, the highest (worst) CCCS value was used for that year.~The results were obtained from a combined analyses of the NIH cysteamine studies evaluating various cysteamine ophthalmic solution formulations from 1986 through 2005."|Any Time Point Up to 19 Years|One hundred sixty-one (161) participants were analyzed in the pre-specified intent-to-treat population [defined as patients who received study medication (between 1986 and 2005), and had a baseline and a post-baseline CCCS value]. After 2005, all participants enrolled received open-label treatment and only safety data was obtained.|||eyes|Participants||Number
1299103|NCT00001213|Primary|Number of Participants With Serious and Non-Serious Adverse Events|Since efficacy of ophthalmic cysteamine was established and a New Drug Application (NDA) filed, the post-hoc primary outcome measure is the evaluation of safety information. There was no specified time frame for this outcome measure, as safety data was being collected until the drug became available for commercial purchase in May 2013.|Any Time Point up to 27 Years||||participants|||Number
1299104|NCT00001151|Primary|Number of Participants With Normal Serum Calcium Concentrations|Normal calcium concentration 8.2-10.6 mg/dL|1 year average||||participants|||Number
1299120|NCT00000479|Primary|Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer||Average follow-up 10.1 years||||participants|||Number
1299106|NCT00000371|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The slope of SANS total score from baseline to week 8 in the treatment and placebo groups on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model.|Baseline, Week 4, Week 8||||units on a scale/weeks||Standard Error|Mean
1299107|NCT00000620|Secondary|First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior occurrence of event.|||participants|||Number
1299108|NCT00000620|Primary|First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.|||participants|||Number
1299109|NCT00000620|Secondary|Stroke in the Blood Pressure Trial.|Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of stroke.|||participants|||Number
1299110|NCT00000620|Primary|First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.|||participants|||Number
1299111|NCT00000620|Secondary|Death From Any Cause in the Glycemia Trial.|"Time to death from any cause. Secondary measure for Glycemia Trial.~A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid)."|4.9 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to death.|||participants|||Number
1299112|NCT00000620|Primary|First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.|"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).~In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion."|4.9 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.|||participants|||Number
1299113|NCT00000575|Secondary|Standardized Depression Scale -- Children's Depression Inventory|Change in total score on the Children's Depression Inventory from baseline to the end of treatment, 4-6 years later. The total score ranges from 0-54 with higher scores indicating greater levels of depression.|4-6 years from baseline||||units on a scale||Standard Deviation|Mean
1299114|NCT00000575|Secondary|Change in Height From Baseline to End of Treatment, 4-6 Years Later|Change in standing height from baseline to end of treatment. Standing height is measured three times without shoes using a calibrated Harpenden stadiometer; the average of the three repeated heights to the nearest 0.1 cm is the height measure at either baseline or end of treatment.|4-6 years from baseline||||cm||Standard Deviation|Mean
1299115|NCT00000575|Secondary|Mortality|Counts of deaths from asthma.|4-6 years from baseline||||participants|||Number
1299116|NCT00000575|Secondary|Need for Urgent Care for Asthma|Counts during the period of treatment (4-6 years) of visits to emergency rooms or equivalent urgent care settings for asthma treatment.|4-6 years from baseline||||rate per 100 person years|||Number
1299117|NCT00000575|Secondary|Change From Baseline in the Rate of Asthma Free Days|Change from baseline proportion of days without asthma symptoms or other asthma related events to proportion of days during the 4-6 years of follow-up. Asthma free days were determined from daily asthma diaries kept from baseline to the end of treatment, 4-6 years later.|4-6 years from baseline||||days per month||Standard Deviation|Mean
1299118|NCT00000575|Secondary|Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs|Bronchial responsiveness to serial concentrations of inhaled methacholine solution (mg/ml) as measured by serial ratios of follow-up to baseline FEV1 (forced volume of air expired from the lungs in one second). A dose-response curve is calculated from the serial ratios in relation to the serial concentrations to determine PC20, the concentration associated with a 20% drop from baseline in FEV1; this PC20 is the outcome measure with units mg/ml of methacholine.|4-6 years from baseline||||mg/ml of methacholine||Standard Deviation|Geometric Mean
1299119|NCT00000575|Primary|Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period|Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). Percent predicted determined from three separate published sets of reference equations for white, black, and Hispanic children - see NEJM 343: 1054-1062, 2000 for more details and references.|At the end of treatment, 4-6 years from baseline assessment||||percentage of predicted value||Standard Deviation|Mean
1299122|NCT00004500|Secondary|Number of Participants With Air Leaks|Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium|28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."|||participants|||Number
1299123|NCT00004500|Secondary|Incidence of Death||28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."|||participants|||Number
1299124|NCT00004500|Primary|Number of Days Receiving Mechanical Ventilation (MV)|A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.|28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."|||days||Standard Deviation|Mean
1299125|NCT00004412|Secondary|% Ulcers Which Completely Healed in Each Group, After 3 Months|Control Arm: given option to crossover to Treatment Arm if, ulcers have not closed after 12 weeks standard local care alone.|two additional courses of 8 week cycles|Per Protocol|||percentage of completely healed ulcers|Participants||Number
1299126|NCT00004412|Primary|Healing Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area|"Treatment Arm: The AB is given as an IV infusion at 500 mg/kg over 6-9 hrs. 5 days per week for 12 weeks. After 12 weeks of therapy, if he ulcer has decreased by 25% , the AB may be continued for additional 8 weeks (twice) or, until ulcer closes plus 2 weeks, additionally.~Ulcers photographed, traced, and ulcer areas calculated by computerized planimetry."|participants were followed for an average of 3 months|Per protocol|||percentage of healed ulcers|Participants||Number
1299127|NCT00000143|Primary|Survival||3 years||||participants|||Number
1299128|NCT00000142|Primary|Survival||All patients enrolled will be followed until a common study closing date||||participants|||Number
1299129|NCT00000136|Primary|Mortality||All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.||||participants|||Number
1299130|NCT00000135|Primary|Mortality Rate|to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .|All patients enrolled were followed for a 17 month period or until a common study closing date||||deaths per person-year|||Number
1299131|NCT00000134|Primary|Morbidity|To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.|Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial||||participants|||Number
1299132|NCT00000125|Primary|Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients|Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.|5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)|1636 ocular hypertensive participants were randomized to either close observation or treatment with topical hypotensive eyedrops from February 1994 through June 2002. In June 2002 the observation participants were offered treatment with topical hypotensive eyedrops.|||percent of participants|||Number
